Sec. 23, 161, 68 Stat. 925, 948, as amended (42 U.S.C. 2033, 2201); sec. 29, Pub. L. 85-256, 71 Stat. 579, Pub. L. 95-209, 91 Stat. 1483 (42 U.S.C. 2039); sec. 191, Pub. L. 87-615, 76 Stat. 409 (42 U.S.C. 2241); secs. 201, 203, 204, 205, 209, 88 Stat. 1242, 1244, 1245, 1246, 1248, as amended (42 U.S.C. 5841, 5843, 5844, 5845, 5849); 5 U.S.C. 552, 553; Reorganization Plan No. 1 of 1980, 45 FR 40561, June 16, 1980.
(a) The Nuclear Regulatory Commission was established by the Energy Reorganization Act of 1974, as amended, Pub. L. 93-438, 88 Stat. 1233 (42 U.S.C. 5801
(b) As used in this part:
(a) A statement of the NRC's organization, policies, procedures, assignments of responsibility, and delegations of authority is in the Nuclear Regulatory Commission Management Directives System and other NRC issuances, including local directives issued by Regional Offices. Letters and memoranda containing directives, delegations of authority and the like are also issued from time to time and may not yet be incorporated into the Management Directives System, parts of which are revised as necessary. Copies of the Management Directives System and other delegations of authority are available for public inspection and copying for a fee at the NRC Public Document Room, One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland 20852-2738, and at each of NRC's Regional Offices. Information may also be obtained from the Office of Public Affairs or from Public Affairs Officers at the Regional Offices. In addition, NRC Functional Organization Charts, NUREG-0325, contains detailed descriptions of the functional responsibilities of NRC's offices. It is revised annually and is available for public inspection at the NRC Web site, http://www.nrc.gov, and/or at the NRC Public Document Room, or for purchase from the Superintendent of Documents, US Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082; and from the National Technical Information Service, Springfield, VA 22161.
(b) Commission meetings are open to the public, as provided by the Government in the Sunshine Act, unless they fall within an exemption to the Act's openness requirement and the Commission also has determined that the public interest requires that those particular meetings be closed. Information concerning Commission meetings may be obtained from the Office of the Secretary.
(c) Information regarding the availability of NRC records under the Freedom of Information Act and the Privacy Act of 1974 may be obtained from the Information Management Division, Office of the Chief Information Officer. NRC's regulations are published in the
(a) The principal NRC offices are located in the Washington, DC, area. Facilities for the service of process and papers are maintained in the State of Maryland at 11555 Rockville Pike, Rockville, Maryland 20852-2738. The agency's official mailing address is U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The locations of NRC offices in the Washington, DC, area are as follows:
(1) One White Flint North Building, 11555 Rockville Pike, Rockville, Maryland 20852-2738.
(2) Two White Flint North Building, 11545 Rockville Pike, Rockville, Maryland 20852-2738.
(b) The addresses of the NRC Regional Offices are as follows:
(1) Region 1, USNRC, 475 Allendale Road, King of Prussia, PA 19406-1415.
(2) Region II, USNRC, Sam Nunn Atlanta Federal Center, 61 Forsyth Street, SW., Suite 23T85, Atlanta, GA 30303-3415.
(3) Region III, USNRC, 801 Warrenville Road, Lisle, IL 60532-4351.
(4) Region IV, USNRC, 611 Ryan Plaza Drive, Suite 400, Arlington, TX 76011-8064.
(a) The Nuclear Regulatory Commission, composed of five members, one of whom is designated by the President as Chairman, is established pursuant to section 201 of the Energy Reorganization Act of 1974, as amended. The Chairman is the principal executive officer of the Commission, and is responsible for the executive and administrative functions with respect to appointment and supervision of personnel, except as otherwise provided by the Energy Reorganization Act of 1974, as amended, and Reorganizaton Plan No. 1 of 1980 (45 FR 40561); distribution of business; use and expenditures of funds (except that the function of revising budget estimates and purposes is reserved to the Commission); and appointment, subject to approval of the Commission, of heads of major administrative units under the Commission. The Chairman is the official spokesman, as mandated by the Reorganization Plan No. 1 of 1980. The Chairman has ultimate authority for all NRC functions pertaining to an emergency involving an NRC Licensee. The Chairman's actions are governed by the general policies of the Commission.
(b) The Commission is responsible for licensing and regulating nuclear facilities and materials and for conducting research in support of the licensing and regulatory process, as mandated by the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and the Nuclear Nonproliferation Act of 1978; and in accordance with the National Environmental Policy Act of 1969, as amended, and other applicable statutes. These responsibilities include protecting public health and safety, protecting the environment, protecting and safeguarding nuclear materials and nuclear power plants in the interest of national security, and assuring conformity with antitrust laws. Agency functions are performed through standards setting and rulemaking; technical reviews and studies; conduct of public hearings; issuance of authorizations, permits, and licenses; inspection, investigation, and enforcement; evaluation of operating experience; and confirmatory research. The Commission is composed of five members, appointed by the President and confirmed by the Senate.
(c) The following staff units and officials report directly to the Commission: Atomic Safety and Licensing Board Panel, Office of the General Counsel, Office of the Secretary, Office of Commission Appellate Adjudication, Office of International Programs, and other committees and boards that are authorized or established specifically by the Act. The Advisory Committee on Reactor Safeguards and the Advisory Committee on Nuclear Waste also report directly to the Commission.
(d) The Offices of Congressional Affairs and Public Affairs report directly to the Chairman.
(a) Develops policies and standards that govern NRC's financial and management audit program;
(b) Plans, directs, and executes the long-range, comprehensive audit program;
(c) Conducts and reports on investigations and inquiries, as necessary, to ascertain and verify the facts with regard to the integrity of all NRC programs and operations;
(d) Investigates possible irregularities or alleged misconduct of NRC employees and contractors;
(e) Refers suspected or alleged criminal violations concerning NRC employees or contractors to the Department of Justice;
(f) Reviews existing and proposed legislation and regulations for their impact on economy and efficiency in the administration of NRC's programs and operations;
(g) Keeps the Commission and the Congress fully and currently informed, by means of semiannual and other reports, about fraud, abuse, and other serious deficiencies in NRC's programs and operations; and
(h) Maintains liaison with audit and inspector general organizations and
The Advisory Committee on Reactor Safeguards (ACRS) was established by section 29 of the Atomic Energy Act of 1954, as amended. Consisting of a maximum of 15 members, it reviews and reports on safety studies and applications for construction permits and facility operating licenses; advises the Commission with regard to hazards of proposed or existing reactor facilities and the adequacy of proposed reactor safety standards; upon request of the Department of Energy (DOE), reviews and advises with regard to the hazards of DOE nuclear activities and facilities; reviews any generic issues or other matters referred to it by the Commission for advice. The Committee, on its own initiative, may conduct reviews of specific generic matters or nuclear facility safety-related items. The ACRS conducts studies of reactor safety research and submits reports thereon to the U.S. Congress and the NRC as appropriate.
The Atomic Safety and Licensing Board Panel, established pursuant to section 191 of the Atomic Energy Act of 1954, as amended, conducts hearings for the Commission and such other regulatory functions as the Commission authorizes. The Panel is comprised of any number of Administrative Judges (full-time and part-time), who may be lawyers, physicists, engineers, and environmental scientists; and Administrative Law Judges, who hear antitrust, civil penalty, and other cases and serve as Atomic Safety and Licensing Board Chairmen. The Chief Administrative Judge develops and applies procedures governing the activities of Boards, Administrative Judges, and Administrative Law Judges and makes appropriate recommendations to the Commission concerning the rules governing the conduct of hearings. The Panel conducts all licensing and other hearings as directed by the Commission primarily through individual Atomic Safety and Licensing Boards composed of one or three Administrative Judges. Those boards are appointed by either the Commission or the Chief Administrative Judge.
The Advisory Committee on Nuclear Waste (ACNW) provides advice to the Commission on all aspects of nuclear waste management, as appropriate, within the purview of NRC's regulatory responsibilities. The primary emphasis of the ACNW is disposal but will also include other aspects of nuclear waste management such as handling, processing, transportation, storage, and safeguarding of nuclear wastes including spent fuel, nuclear wastes mixed with other hazardous substances, and uranium mill tailings. In performing its work, the committee examines and reports on specific areas of concern referred to it by the Commission or designated representatives of the Commission, and undertakes studies and activities on its own initiative as appropriate to carry out its responsibilities. The committee interacts with representatives of NRC, other Federal agencies, state and local governments, Indian Tribes, and private organizations, as appropriate, to fulfill its responsibilities.
Under section 161a. of the Atomic Energy Act of 1954, as amended, the Commission may establish advisory bodies to make recommendations to it. Currently, four committees are in existence.
(a) The Advisory Committee on Medical Uses of Isotopes (ACMUI) was established by the Atomic Energy Commission in July 1958. The ACMUI, composed of physicians and scientists, considers medical questions referred to it by the NRC staff and renders expert opinions regarding medical uses of radioisotopes. The ACMUI also advises
(b) The Advisory Committee for the Decontamination of Three Mile Island, Unit 2, was established by the NRC in October 1980. Its purpose is to obtain input and views from the residents of the Three Mile Island area and afford Pennsylvania government officials an opportunity to participate in the Commission's decisional process regarding cleanup for Three Mile Island, Unit 2.
(c) The Nuclear Safety Research Review Committee (NSRRC) was established by the NRC in February 1988 for the purpose of reporting to the Commission through the Director of the Office of Nuclear Regulatory Research on important management matters in the direction of the Commission's nuclear safety research program. The committee activities cover all aspects of nuclear safety research including, but not limited to, accident management, plant aging, human factors and system reliability, earth science, waste disposal and seismic and structural engineering. In performing its activities, the committee evaluates and reports on the conformance of the nuclear safety research program to the NRC philosophy of nuclear regulatory research. The committee conducts specialized studies when requested by the Commission or Director of the Office of Nuclear Regulatory Research. The committee interacts with the Office of Research management staff and selected contractors in private industry, at national laboratories and universities.
(d) The Licensing Support System Advisory Review Panel (LSSARP) was established by the Commission on October 3, 1989, pursuant to 10 CFR 2.1011(e) of the Commission's regulations. The LSSARP provides advice to the Commission on the design, development, and operation of the Licensing Support System (LSS), an electronic information management system for use in the Commission's high-level radioactive waste (HLW) licensing proceeding. Membership consists of those interests that will be affected by the use of the LSS, and selected Federal agencies with expertise in large-scale electronic information systems. The individual representatives of these interests and agencies possess expertise in management information science and in managing records of the Commission's licensing process for the HLW repository.
The Office of the General Counsel, established pursuant to section 25 of the Atomic Energy Act of 1954, as amended—
(a) Directs matters of law and legal policy, providing opinions, advice, and assistance to the agency with respect to all of its activities;
(b) Reviews and prepares appropriate draft Commission decisions on public petitions seeking direct Commission action and rulemaking proceedings involving hearings, monitors cases pending before presiding officers and reviews draft Commission decisions on Atomic Safety and Licensing Board decisions and rulings;
(c) Provides interpretation of laws, regulations, and other sources of authority;
(d) Reviews the legal form and content of proposed official actions;
(e) As requested, provides the agency with legal advice and opinions on acquisition matters, including agency procurement contracts; placement of work at Department of Energy national laboratories; interagency agreements to acquire supplies and services; and grants and cooperative agreements. Prepares or concurs in all other interagency agreements, delegations of authority, regulations; orders; licenses; and other legal documents and prepares legal interpretations thereof;
(f) Reviews and directs intellectual property (patent) work;
(g) Represents and protects the interests of the NRC in legal matters and in court proceedings, and in relation to other government agencies, administrative bodies, committees of Congress, foreign governments, and members of the public; and
(h) Represents the NRC staff as a party in NRC administrative hearings.
The Office of Commission Appellate Adjudication—
(a) Monitors cases pending before presiding officers;
(b) Provides the Commission with an analysis of any adjudicatory matter requiring a Commission decision (e.g., petitions for review, certified questions, stay requests) including available options;
(c) Drafts any necessary decisions pursuant to the Commission's guidance after presentation of options; and
(d) Consults with the Office of the General Counsel in identifying the options to be presented to the Commission and in drafting the final decision to be presented to the Commission.
The Office of the Secretary of the Commission—
(a) Provides general management services to support the Commission and to implement Commission decisions; and advises and assists the Commission and staff on the planning, scheduling, and conduct of Commission business including preparation of internal procedures;
(b) Prepares the Commission's meeting agenda;
(c) Manages the Commission Staff Paper and COMSECY systems;
(d) Receives, processes, and controls Commission mail, communications, and correspondence;
(e) Maintains the Commission's official records and acts as Freedom of Information administrative coordinator for Commission records;
(f) Codifies Commission decisions in memoranda directing staff action and monitors compliance;
(g) Receives, processes, and controls motions and pleadings filed with the Commission; issues and serves adjudicatory orders on behalf of the Commission; receives and distributes public comments in rulemaking proceedings, issues proposed and final rules on behalf of the Commission; maintains the official adjudicatory and rulemaking dockets of the Commission; and exercises responsibilities delegated to the Secretary in 10 CFR 2.702 and 2.772;
(h) Administers the NRC Historical Program;
(i) Integrates office automation initiatives into the Commission's administrative system;
(j) Functions as the NRC Federal Advisory Committee Management Officer; and
(k) Provides guidance and direction on the use of the NRC seal and flag.
The Office of Congressional Affairs—
(a) Advises the Chairman, the Commission, and NRC staff on all NRC relations with Congress and the views of Congress toward NRC policies, plans and activities;
(b) Maintains liaison with Congressional committees and members of Congress on matters of interest to NRC;
(c) Serves as primary contact point for all NRC communications with Congress;
(d) Coordinates NRC internal activities with Congress;
(e) Plans, develops, and manages NRC's legislative programs; and
(f) Monitors legislative proposals, bills, and hearings.
The Office of Public Affairs—
(a) Develops policies, programs, and procedures for the Chairman's approval for informing the public of NRC activities;
(b) Prepares, clears, and disseminates information to the public and the news media concerning NRC policies, programs, and activities;
(c) Keeps NRC management informed on media coverage of activities of interest to the agency;
(d) Plans, directs, and coordinates the activities of public information staffs located at Regional Offices;
(e) Conducts a cooperative program with schools; and
(f) Carries out assigned activities in the area of consumer affairs.
The Office of International Programs—
(a) Advises the Chairman, the Commission, and NRC staff on international issues;
(b) Recommends policies concerning nuclear exports and imports, international safeguards, international physical security, nonproliferation matters, and international cooperation and assistance in nuclear safety and radiation protection;
(c) Plans, develops, and manages international nuclear safety information exchange programs and coordinates international research agreements;
(d) Obtains, evaluates, and uses pertinent information from other NRC and U.S. Government offices in processing nuclear export and import license applications;
(e) Establishes and maintains working relationships with individual countries and international nuclear organizations, as well as other involved U.S. Government agencies; and
(f) Assures that all international activities carried out by the Commission and staff are well coordinated internally and Government-wide and are consistent with NRC and U.S. policies.
The Office of the Chief Financial Officer—
(a) Oversees all financial management activities relating to NRC's programs and operations and provides advice to the Chairman on financial management matters;
(b) Develops and transmits the NRC's budget estimates to the Office of Management and Budget (OMB) and Congress;
(c) Establishes financial management policy including accounting principles and standards for the agency and provides policy guidance to senior managers on the budget and all other financial management activities;
(d) Provides an agencywide management control program for financial and program managers that establishes internal control processes and provides for timely corrective actions regarding material weaknesses that are disclosed to comply with the Federal Manager's Financial Integrity Act of 1982;
(e) Develops and manages an agencywide planning, budgeting, and performance management process;
(f) Develops and maintains an integrated agency accounting and financial management system, including an accounting system, and financial reporting and internal controls;
(g) Directs, manages, and provides policy guidance and oversight of agency financial management personnel activities and operations;
(h) Prepares and transmits an annual financial management report to the Chairman and the Director, Office of Management and Budget, including an audited financial statement;
(i) Monitors the financial execution of NRC's budget in relation to actual expenditures, controls the use of NRC funds to ensure that they are expended in accordance with applicable laws and financial management principles, and prepares and submits to the Chairman timely cost and performance reports;
(j) Establishes, maintains, and oversees the implementation of license fee polices and regulations; and
(k) Reviews, on a periodic basis, fees and other charges imposed by NRC for services provided and makes recommendations for revising those charges, as appropriate.
(a) The Executive Director for Operations (EDO) reports for all matters to
(b) The EDO supervises and coordinates policy development and operational activities in the following line offices; the Office of Nuclear Reactor Regulation, the Office of Nuclear Material Safety and Safeguards, the Office of Nuclear Regulatory Research, and the NRC Regional Offices; and the following staff offices: The Office of Enforcement, the Office of Administration, the Office of Investigations, Incident Response Operations, the Office of Small Business and Civil Rights, the Office of Human Resources, the Office of State Programs, and other organizational units as shall be assigned by the Commission. The EDO is also responsible for implementation of the Commission's policy directives pertaining to these offices.
(c) The EDO exercises powers and functions delegated to the EDO under the Reorganization Plan No. 1 of 1980, this chapter, or otherwise by the Commission or Chairman, as appropriate. The EDO has the authority to perform any function that may be performed by an office director reporting to the EDO.
The Office of Enforcement—
(a) Develops policies and programs for enforcement of NRC requirements;
(b) Manages major enforcement actions; and
(c) Assesses the effectiveness and uniformity of Regional enforcement actions.
The Office of Administration—
(a) Develops and implements agencywide contracting policies and procedures;
(b) Develops policies and procedures and manages the operation and maintenance of NRC offices, facilities, and equipment;
(c) Plans, develops, establishes, and administers policies, standards, and procedures for the overall NRC security program; and
(d) Develops and implements policies and procedures for the review and publication of NRC rulemakings, and ensures compliance with the Regulatory Flexibility Act and the Small Business Regulatory Enforcement Fairness Act, manages the NRC management directives program, and provides translations services.
The Office of the Chief Information Officer—
(a) Plans, directs, and oversees the NRC's information resources, including technology infrastructure and delivery of information management services, to meet the mission and goals of the agency;
(b) Provides principal advice to the Chairman to ensure that information technology (IT) is acquired and information resources across the agency are managed in a manner consistent with Federal information resources management (IRM) laws and regulations;
(c) Assists senior management in recognizing where information technology can add value while improving NRC operations and service delivery;
(d) Directs the implementation of a sound and integrated IT architecture to achieve NRC's strategic and IRM goals;
(e) Monitors and evaluates the performance of information technology and information management programs based on applicable performance measures and assesses the adequacy of IRM skills of the agency;
(f) Provides guidance and oversight for the selection, control and evaluation of information technology investments; and
(g) Provides oversight and quality assurance for the design and operation of the Licensing Support System (LSS) services and for the completeness and integrity of the LSS database, ensures that the LSS meets the requirements of 10 CFR part 2, subpart J, concerning the use of the LSS in the Commission's high-level waste licensing proceedings,
The Office of Investigations (OI)—
(a) Conducts investigations of licensees, applicants, their contractors or vendors, including the investigation of all allegations of wrongdoing by other than NRC employees and contractors;
(b) Maintains current awareness of inquiries and inspections by other NRC offices to identify the need for formal investigations;
(c) Makes appropriate referrals to the Department of Justice;
(d) Maintains liaison with other agencies and organizations to ensure the timely exchange of information of mutual interest; and
(e) Issues subpoenas where necessary or appropriate for the conduct of investigations.
The Office of Small Business and Civil Rights—
(a) Develops and implements an effective small and disadvantaged business program in accordance with the Small Business Act, as amended, and plans and implements NRC policies and programs relating to equal employment oppportunity and civil rights matters as required by the Equal Employment Opportunity Commission (EEOC) and the Office of Personnel Management (OPM);
(b) Ensures that appropriate consideration is given to Labor Surplus Area firms and Women Business Enterprises, and conducts an outreach program aimed at contractors desiring to do business with NRC;
(c) Maintains liaison with other Government agencies and trade associations;
(d) Coordinates efforts with the Director, Division of Contracts, and Directors of other affected offices;
(e) Develops and recommends for approval by the Executive Director for Operations, NRC policy providing for equal employment opportunity in all aspects of Federal personnel practice;
(f) Develops, monitors, and evaluates the agency's equal employment opportunity efforts and affirmative action programs to ensure compliance with NRC policy;
(g) Serves as the principal contact with local and national public and private organizations to facilitate the NRC equal opportunity program; and
(h) Coordinates all efforts pertaining to small and disadvantaged business utilization and equal employment opportunity with Office Directors and Regional Administrators.
The Office of Human Resources—
(a) Plans and implements NRC policies, programs, and services to provide for the effective organization, utilization, and development of the agency's human resources;
(b) Provides labor relations and personnel policy guidance and supporting services to NRC managers and employees;
(c) Provides training, benefits administration, and counseling services for NRC employees;
(d) Collects, analyzes, and provides data on the characteristics, allocation, utilization, and retention of NRC's workforce;
(e) Provides staffing advice and services to NRC managers and employees; and
(f) Provides executive resources management and organizational and managerial development services to the NRC.
The Office of State Programs—
(a) Plans and directs NRC's program of cooperation and liaison with States, local governments, interstate and Indian Tribe organizations; and coordinates liaison with other Federal Agencies;
(b) Participates in formulation of policies involving NRC/State cooperation and liaison;
(c) Develops and directs administrative and contractual programs for coordinating and integrating Federal and State regulatory activities;
(d) Maintains liaison between NRC and State, interstate, regional, Indian Tribe, and quasi-governmental organizations on regulatory matters;
(e) Promotes NRC visibility and performs general liaison with other Federal Agencies, and keeps NRC management informed of significant developments at other Federal Agencies which affect the NRC;
(f) Monitors nuclear-related State legislative activities;
(g) Directs regulatory activities of State Liaison and State Agreement Officers located in Regional Offices;
(h) Participates in policy matters on State Public Utility Commissions (PUCs);
(i) Administers the State Agreements program in a partnership arrangement with the States;
(j) Develops staff policy and procedures and implementation of the State Agreements program under the provisions of section 274b of the Atomic Energy Act, as amended;
(k) Provides oversight of program of periodic routine reviews of Agreement State programs to determine their adequacy and compatibility as required by section 274j of the Act and other periodic reviews that may be performed to maintain a current level of knowledge of the status of the Agreement State programs;
(l) Provides training to the States as provided by section 274i of the Act and also to NRC staff and staff of the U.S. Navy and U.S. Air Force;
(m) Provides technical assistance to Agreement States;
(n) Maintains an exchange of information with the States;
(o) Conducts negotiations with States expressing an interest in seeking a section 274b Agreement;
(p) Supports, consistent with Commission directives, State efforts to improve regulatory control for radiation safety over radioactive materials not covered by the Act; and
(q) Serves as the NRC liaison to the Conference of Radiation Control Program Directors, Inc. (CRCPD) and coordinates NRC technical support of CRCPD committees.
(a) The Office of Nuclear Material Safety and Safeguards is responsible for protecting the public health and safety, the common defense and security, and the environment by licensing, inspection, and environmental impact assessment for all nuclear facilities and activities, and for the import and export of special nuclear material.
(b) The Office responsibilities include—
(1) Development and promulgation of regulations;
(2) Development and implementation of NRC policy for the regulation of activities involving safety, quality, approval, and inspection of the use and handling of nuclear and other radioactive materials, such as uranium activities;
(3) Fuel fabrication and fuel development;
(4) Medical, industrial, academic, and commercial uses of radioactive isotopes;
(5) Safeguards activities;
(6) Transportation of nuclear materials, including certification of transport containers;
(7) Out-of-reactor spent fuel storage;
(8) Safe management and disposal of low-level and high-level radioactive wastes;
(9) Planning and direction of program for financial assurance of NMSS licensees; and
(10) Management of the decommissioning of facilities and sites when their licensed functions are over.
(c) Safeguards responsibilities include—
(1) Development of overall agency policy;
(2) Monitoring and assessment of the threat environment, including liaison with intelligence agencies, as appropriate; and
(3) Those licensing and review activities appropriate to deter and protect against threats of radiological sabotage and threats of theft or diversion of special nuclear material at fuel facilities and during transport.
(d) The Office identifies and takes action to control safety and safeguards issues for activities under its responsibility, including consulting and coordinating with international, Federal, State, and local agencies, as appropriate.
The Office of Nuclear Reactor Regulation—
(a) Develops, promulgates and implements regulations and develops and implements policies, programs, and procedures for all aspects of licensing, inspection, and safeguarding of—
(1) Manufacturing, production, and utilization facilities, except for those concerning fuel reprocessing plants and isotopic enrichment plants;
(2) Receipt, possession, and ownership of source, byproduct, and special nuclear material used or produced at facilities licensed under 10 CFR part 50;
(3) Operators of such facilities;
(4) Emergency preparedness at such facilities; and
(5) Contractors and suppliers of such facilities.
(b) Identifies and takes action regarding conditions and licensee performance that may adversely affect public health and safety, the environment, or the safeguarding of nuclear reactor facilities;
(c) Assesses and recommends or takes action regarding incidents or accidents;
(d) Provides special assistance as required in matters involving reactor facilities exempt from licensing;
(e) Provides guidance and implementation direction to Regional Offices on reactor licensing, inspection, and safeguards programs assigned to the Region, and appraises Regional program performance in terms of effectiveness and uniformity;
(f) Performs other functions required for implementation of the reactor licensing, inspection, and safeguards programs;
(g) Performs management of the NRC allegation program; and
(h) Performs review and evaluation related to regulated facilities insurance, indemnity, and antitrust matters.
The Office of Nuclear Regulatory Research—
(a) Plans, recommends, and implements programs of nuclear regulatory research, standards development, and resolution of generic safety issues for nuclear power plants and other facilities regulated by the NRC;
(b) Coordinates research activities within and outside the agency including appointment of staff to committees and conferences; and
(c) Coordinates NRC participation in international standards-related activities and national volunteer standards efforts, including appointment of staff to committees.
Each Regional Administrator executes established NRC policies and assigned programs relating to inspection, enforcement, licensing, State agreements, State liaison, and emergency response within Regional boundaries set out in § 1.5(b) of this part.
(a) Pursuant to section 201(a) of the Energy Reorganization Act of 1974, the Nuclear Regulatory Commission, has adopted an official seal. Its description is as follows: An American bald eagle (similar to that on the Great Seal of the United States of America) of brown and tan with claws and beak of yellow, behind a shield of red, white, and blue, clutching a cluster of thirteen arrows
(b) The Official Seal of the Nuclear Regulatory Commission is illustrated as follows:
(c) The Secretary of the Commission is responsible for custody of the impression seals and of replica (plaque) seals.
(a) The use of the seal or replicas is restricted to the following:
(1) NRC letterhead stationery;
(2) NRC award certificates and medals;
(3) Security credentials and employee identification cards;
(4) NRC documents, including agreements with States, interagency or governmental agreements, foreign patent applications, certifications, special reports to the President and Congress and, at the discretion of the Secretary of the Commission, such other documents as the Secretary finds appropriate;
(5) Plaques—the design of the seal may be incorporated in plaques for display at NRC facilities in locations such as auditoriums, presentation rooms, lobbies, offices of senior officials, on the fronts of buildings, and other places designated by the Secretary;
(6) The NRC flag (which incorporates the design of the seal);
(7) Official films prepared by or for the NRC, if deemed appropriate by the Director of Governmental and Public Affairs;
(8) Official NRC publications that represent an achievement or mission of NRC as a whole, or that are cosponsored by NRC and other Government departments or agencies; and
(9) Any other uses as the Secretary of the Commission finds appropriate.
(b) Any person who uses the official seal in a manner other than as permitted by this section shall be subject to the provisions of 18 U.S.C. 1017, which provides penalties for the fraudulent or wrongful use of an official seal, and to other provisions of law as applicable.
The official flag is based on the design of the NRC seal. It is 50 inches by 66 inches in size with a 38-inch diameter seal incorporated in the center of a dark blue field with a gold fringe.
(a) The use of the flag is restricted to the following:
(1) On or in front of NRC installations;
(2) At NRC ceremonies;
(3) At conferences involving official NRC participation (including permanent display in NRC conference rooms);
(4) At Governmental or public appearances of NRC executives;
(5) In private offices of senior officials; or
(6) As the Secretary of the Commission otherwise authorizes.
(b) The NRC flag must only be displayed together with the U.S. flag.
In order to ensure adherence to the authorized uses of the NRC seal and flag as provided in this subpart, a report of each suspected violation of this subpart, or any questionable use of the NRC seal or flag, should be submitted to the Secretary of the Commission.
Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C. 2201, 2231); sec. 191, as amended, Pub. L. 87-615, 76 Stat. 409 (42 U.S.C. 2241); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); 5 U.S.C. 552.
Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 U.S.C. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f); Pub. L. 97-425, 96 Stat. 2213, as amended (42 U.S.C. 10143(f)); sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301, 88 Stat. 1248 (42 U.S.C. 5871). Section 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183i, 189, 68 Stat. 936, 937, 938, 954, 955, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2233, 2239). Section 2.105 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Sections 2.200-2.206 also issued under secs. 161 b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 U.S.C. 2201 (b), (i), (o), 2236, 2282); sec. 206, 88 Stat 1246 (42 U.S.C. 5846). Sections 2.205(j) also issued under Pub. L. 101-410, 104 Stat. 90, as amended by section 3100(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note). Section 2.600-2.606 also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332). Section 2.700a, 2.719 also issued under 5 U.S.C. 554. Sections 2.754, 2.760, 2.770, 2.780 also issued under 5 U.S.C. 557. Section 2.764 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 U.S.C. 2133) and 5 U.S.C. 552. Sections 2.800 and 2.808 also issued under 5 U.S.C. 553, Section 2.809 also issued under 5 U.S.C. 553, and sec. 29, Pub. L. 85-256, 71 Stat. 579, as amended (42 U.S.C. 2039). Subpart K also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. L. 97-425, 96 Stat. 2230 (42 U.S.C. 10154). Subpart L also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Subpart M also issued under sec. 184 (42 U.S.C. 2234) and sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Appendix A also issued under sec. 6, Pub. L. 91-560, 84 Stat. 1473 (42 U.S.C. 2135).
This part governs the conduct of all proceedings, other than export and import licensing proceedings described in part 110, under the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, for—
(a) Granting, suspending, revoking, amending, or taking other action with respect to any license, construction permit, or application to transfer a license;
(b) Issuing orders and demands for information to persons subject to the Commission's jurisdiction, including licensees and persons not licensed by the Commission;
(c) Imposing civil penalties under section 234 of the Act; and
(d) Public rulemaking.
Each subpart other than subpart G sets forth special rules applicable to the type of proceeding described in the first section of that subpart. Subpart G sets forth general rules applicable to
In any conflict between a general rule in subpart G of this part and a special rule in another subpart or other part of this chapter applicable to a particular type of proceeding, the special rule governs.
As used in this part,
(1) The Commissioners and members of their personal staffs;
(2) The employees of the Office of Commission Appellate Adjudication;
(3) The members of the Atomic Safety and Licensing Board Panel and staff assistants to the Panel;
(4) A presiding officer appointed under § 2.704, including an administrative law judge, and staff assistants to a presiding officer;
(5) Special assistants (as defined in § 2.772);
(6) The General Counsel, the Solicitor, the Deputy General Counsel for Licensing and Regulation, and employees of the Office of the General Counsel under the supervision of the Solicitor or the Deputy General Counsel for Licensing and Regulation;
(7) The Secretary and employees of the Office of the Secretary; and
(8) Any other Commission officer or employee who is appointed by the Commission, the Secretary, or the General Counsel to participate or advise in the Commission's consideration of an initial or final decision in a proceeding. Any other Commission officer or employee who, as permitted by § 2.781, participates or advises in the Commission's consideration of an initial or final decision in a proceeding must be appointed as a Commission adjudicatory employee under this paragraph and the parties to the proceeding must be given written notice of the appointment.
(1) Personal participation in planning, conducting, or supervising an investigation; or
(2) Personal participation in planning, developing, or presenting, or in supervising the planning, development or presentation of testimony, argument, or strategy in a proceeding.
(1) NRC employees;
(2) For the purpose of §§ 2.720, 2.740, and 2.1018 only, persons acting in the capacity of consultants to the Commission, regardless of the form of the contractual arrangements under which such persons act as consultants to the Commission; and
(3) Members of advisory boards, committees, and panels of the NRC; members of boards designated by the Commission to preside at adjudicatory proceedings; and officers or employees of Government agencies, including military personnel, assigned to duty at the NRC.
Except as redefined in this section, words and phrases which are defined in the Act and in this chapter have the same meaning when used in this part.
For
This part contains no information collection requirements and therefore is not subject to requirements of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
This subpart prescribes the procedures for issuance of a license; amendment of a license at the request of the licensee; and transfer and renewal of alicense.
(a)(1) An application for a license, a license transfer, or an amendment to a license shall be filed with the Director of the Office of Nuclear Reactor Regulation or Director of the Office of Nuclear Material Safety and Safeguards, as prescribed by the applicable provisions of this chapter. A prospective applicant may confer informally with the NRC staff prior to the filing of an application.
(2) Each application for a license for a facility or for receipt of waste radioactive material from other persons for the purpose of commercial disposal by the waste disposal licensee will be assigned a docket number. However, to allow a determination as to whether an application for a construction permit or operating license for a production or utilization facility is complete and acceptable for docketing, it will be initially treated as a tendered application. A copy of the tendered application will be available for public inspection at the NRC Web site,
(3) If the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, determines that a tendered application for a construction permit or operating license for a production or utilization facility, and/or any environmental report required pursuant to subpart A of part 51 of this chapter, or part thereof as provided in paragraphs (a)(5) or (a-1) of this section are complete and acceptable for docketing, a docket number will be assigned to the application or part thereof, and the applicant will be notified of the determination. With respect to the tendered application and/or environmental report or part thereof that is acceptable
(i) Submit to the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, such additional copies as the regulations in part 50 and subpart A of part 51 require;
(ii) Serve a copy on the chief executive of the municipality in which the facility is to be located or, if the facility is not to be located within a municipality, on the chief executive of the county, and serve a notice of availability of the application or environmental report on the chief executives of the municipalities or counties which have been identified in the application or environmental report as the location of all or part of the alternative sites, containing the following information: Docket number of the application, a brief description of the proposed site and facility; the location of the site and facility as primarily proposed and alternatively listed; the name, address, and telephone number of the applicant's representative who may be contacted for further information; notification that a draft environmental impact statement will be issued by the Commission and will be made available upon request to the Commission; and notification that if a request is received from the appropriate chief executive, the applicant will transmit a copy of the application and environmental report, and any changes to such documents which affect the alternative site location, to the executive who makes the request. In complying with the requirements of this paragraph (a)(3)(ii) the applicant should not make public distribution of those parts of the application subject to § 2.790(d). The applicant shall submit to the Director of Nuclear Reactor Regulation an affidavit that service of the notice of availability of the application or environmental report has been completed along with a list of names and addresses of those executives upon whom the notice was served; and
(iii) Make direct distribution of additional copies to Federal, State, and local officials in accordance with the requirements of this chapter and written instructions furnished to the applicant by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate. Such written instructions will be furnished as soon as practicable after all or any part of the application, or environmental report, is tendered. The copies submitted to the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, and distributed by the applicant shall be completely assembled documents, identified by docket number. Subsequently distributed amendments to applications, however, may include revised pages to previous submittals and, in such cases, the recipients will be responsible for inserting the revised pages.
(4) The tendered application for a construction permit or operating license for a production or utilization facility will be formally docketed upon receipt by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, of the required additional copies. Distribution of the additional copies shall be deemed to be complete as of the time the copies are deposited in the mail or with a carrier prepaid for delivery to the designated addresses. The date of docketing shall be the date when the required copies are received by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate. Within ten (10) days after docketing the applicant shall submit to the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, an affidavit that distribution of the additional copies to Federal, State, and local officials has been completed in accordance with requirements of this chapter and written instructions furnished to the applicant by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate. Amendments to the application and environmental report shall be filed and distributed and an affidavit shall be furnished to the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, in the same manner as
(5) An applicant for a construction permit for a production or utilization facility which is subject to § 51.20(b) of this chapter, and is of the type specified in § 50.21(b) (2) or (3) or § 50.22 of this chapter or is a testing facility may submit the information required of applicants by part 50 of the chapter in three parts. One part shall be accompanied by the information required by § 50.30(f) of this chapter, another part shall include any information required by § 50.34(a) and, if applicable, § 50.34a of this chapter and a third part shall include any information required by § 50.33a. One part may precede or follow other parts by no longer than six (6) months except that the part including information required by § 50.33a shall be submitted in accordance with time periods specified in § 50.33a. If an applicant for a construction permit for a nuclear power reactor is exempted pursuant to § 50.33a of this chapter from filing the information described by § 50.33a of this chapter, such applicant shall file with the first part of its application an affidavit setting forth facts as to the electrical generating capacity of its system. If it is determined that any one of the parts as described above is incomplete and not acceptable for processing, the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will inform the applicant of this determination and the respects in which the document is deficient. Such a determination of completeness will generally be made within a period of thirty (30) days. Except for the part including information required by § 50.33a, whichever part is filed first shall also include the fee required by §§ 50.30(e) and 170.21 of this chapter and the information required by §§50.33, 50.34((a)(1), and 50.37 of this chapter. The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will accept for docketing an application for a construction permit for a production or utilization facility which is subject to § 51.20(b) of this chapter, and is of the type specified in § 50.21(b) (2) or (3) or § 50.22 of this chapter or is a testing facility where one part of the application as described above is complete and conforms to the requirements of part 50 of this chapter. Additional parts will be docketed upon a determination by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, that they are complete.
(a-1)
(1) Part one shall include or be accompanied by any information required by §§ 50.34(a)(1) and 50.30(f) of this chapter which relates to the issue(s) of site suitability for which an early review, hearing and partial decision are sought, except that information with respect to operation of the facility at the projected initial power level need not be supplied, and shall include the information required by §§ 50.33 (a) through (e) and 50.37 of this chapter. The information submitted shall also include: (i) Proposed findings on the issues of site suitability on which the applicant has requested review and a statement of the bases or the reasons for those findings, (ii) a range of postulated facility design and operation parameters that is sufficient to enable the Commission to perform the requested review of site suitability issues under the applicable provisions of parts
(2) Part two shall include or be accompanied by the remaining information required by §§ 50.30(f), 50.33 and 50.34(a)(1) of this chapter.
(3) Part three shall include the remaining information required by §§ 50.34a and (in the case of a nuclear power reactor) 50.34(a) of this chapter.
(4) The information required for part two or part three shall be submitted during the period the partial decision on part one is effective. Submittal of the information required for part three may precede by no more than six months or follow by no more than six months the submittal of the information required for part two.
(5) Part four,
(b) After the application has been docketed each applicant for a license for receipt of waste radioactive material from other persons for the purpose of commercial disposal by the waste disposal licensee except applicants under part 61 of this chapter, who must comply with paragraph (g) of this section, shall serve a copy of the application and environmental report, as appropriate, on the chief executive of the municipality in which the activity is to be conducted or, if the activity is not to be conducted within a municipality on the chief executive of the county, and serve a notice of availability of the application or environmental report on the chief executives of the municipalities or counties which have been identified in the application or environmental report as the location of all or part of the alternative sites, containing the following information: Docket number of the application; a brief description of the proposed site and facility; the location of the site and facility as primarily proposed and alternatively listed; the name, address, and telephone number of the applicant's representative who may be contacted for further information; notification that a draft environmental impact statement will be issued by the Commission and will be made available upon request to the Commission; and notification that if a request is received from the appropriate chief executive, the applicant will transmit a copy of the application and environmental report, and any changes to such documents which affect the alternative site location, to the executive who makes the request. In complying with the requirements of this paragraph (b) the applicant should not make public distribution of those parts of the application subject to § 2.790(d). The applicant shall submit to the Director of Nuclear Material Safety and Safeguards an affidavit that service of the notice of availability of the application or environmental report has been completed along with a list of names and addresses of those executives upon whom the notice was served.
(c) The notice published in the
(1) The portion of the application filed contains the information requested by the Attorney General for the purpose of an antitrust review of the application as set forth in appendix L to part 50 of this chapter;
(2) Upon receipt and acceptance for docketing of the remaining portions of the application dealing with radiological health and safety and environmental matters, notice of receipt will be published in the
(3) Any person who wishes to have his views on the antitrust matters of the application considered by the NRC and presented to the Attorney General for consideration should submit such views within sixty (60) days after publication of the notice announcing receipt and
(d) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will give notice of the docketing of the public health and safety, common defense and security, and environmental parts of an application for a license for a facility or for receipt of waste radioactive material from other persons for the purpose of commercial disposal by the waste disposal licensee, except that for applications pursuant to part 61 of this chapter paragraph (g) of this section applies, to the Governor or other appropriate official of the State in which the facility is to be located or the activity is to be conducted and will cause to be published in the
(e)(1) Upon receipt of the antitrust information responsive to Regulatory Guide 9.3 submitted in connection with an application for a facility's initial operating license under section 103 of the Act, the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, shall publish in the
(2) If the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, after reviewing any comments or information received in response to the published notice and any comments or information regarding the applicant received from the Attorney General, concludes that there have been no significant changes since the completion of the previous antitrust review in connection with the construction permit, a finding of no significant changes shall be published in the
(3) If, as a result of a reevaluation of the finding described in paragraph (e)(2) of this section, it is determined that there have been no significant changes, the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, shall deny the request and shall publish a notice of finding of no significant changes in the
(4) If the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, concludes that significant
(f)(1) Each application for a license to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter, and any environmental impact statement required in connection therewith pursuant to subpart A of part 51 of this chapter, shall be processed in accordance with the provisions of this paragraph.
(2) To allow a determination as to whether the application is complete and acceptable for docketing, it will be initially treated as a tendered document, and a copy will be available for public inspection in the Commission's Public Document Room. Twenty copies shall be filed to enable this determination to be made.
(3) If the Director of Nuclear Material Safety and Safeguards determines that the tendered document is complete and acceptable for docketing, a docket number will be assigned and the applicant will be notified of the determination. If it is determined that all or any part of the tendered document is incomplete and therefore not acceptable for processing, the applicant will be informed of this determination and the respects in which the document is deficient.
(4) [Reserved]
(5) If a tendered document is acceptable for docketing, the applicant will be requested to submit to the Director of Nuclear Material Safety and Safeguards such additional copies of the application and environmental impact statement as the regulations in part 60 or 63 and subpart A of part 51 of this chapter require; serve a copy of such application and environmental impact statement on the chief executive of the municipality in which the geologic repository operations area is to be located, or if the geologic repository operations area is not to be located within a municipality, on the chief executive of the county (or to the Tribal organization, if it is to be located within an Indian reservation); and make direct distribution of additional copies to Federal, State, Indian Tribe, and local officials in accordance with the requirements of this chapter, and written instructions from the Director of Nuclear Material Safety and Safeguards. All such copies shall be completely assembled documents, identified by docket number. Subsequently distributed amendments to the application, however, may include revised pages to previous submittals and, in such cases, the recipients are responsible for inserting the revised pages.
(6) The tendered document will be formally docketed upon receipt by the Director of Nuclear Material Safety and Safeguards of the required additional copies. The date of docketing shall be the date when the required copies are received by the Director of Nuclear Material Safety and Safeguards. Within ten (10) days after docketing, the applicant shall submit to the Director of Nuclear Material Safety and Safeguards a written statement that distribution of the additional copies to Federal, State, Indian Tribe, and local officials has been completed in accordance with requirements of this chapter and written instructions furnished to the applicant by the Director of Nuclear Material Safety and Safeguards. Distribution of the additional copies shall be deemed to be complete as of the time the copies are deposited in the mail or with a carrier prepaid for delivery to the designated addressees.
(7) Amendments to the application and supplements to the environmental impact statement shall be filed and distributed and a written statement shall be furnished to the Director of Nuclear Material Safety and Safeguards in the same manner as for the initial application and environmental impact statement.
(8) The Director of Nuclear Material Safety and Safeguards will cause to be published in the
(g) Each application for a license to receive radioactive waste from other persons for disposal under part 61 of this chapter and the accompanying environmental report shall be processed in accordance with the provisions of this paragraph.
(1) To allow a determination as to whether the application or environmental report is complete and acceptable for docketing, it will be initially treated as a tendered document, and a copy will be available for public inspection in the Commission's Public Document Room, One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland 20852-2738. One original and two copies shall be filed to enable this determination to be made.
(i) Upon receipt of a tendered application, the Commission will publish in the
(ii) The Commission will also post a public notice in a newspaper or newspapers of general circulation in the affected States and areas summarizing information contained in the applicant's tendered application and noting the opportunity to submit views and comments.
(iii) When the Director of Nuclear Material Safety and Safeguards determines that the tendered document is complete and acceptable for docketing, a docket number will be assigned and the applicant will be notified of the determination. If it is determined that all or any part of the tendered document is incomplete and therefore not acceptable for processing, the applicant will be informed of this determination and the aspects in which the document is deficient.
(2) With respect to any tendered document that is acceptable for docketing, the applicant will be requested to (i) submit to the Director of Nuclear Material Safety and Safeguards such additional copies as the regulations in part 61 and subpart A of part 51 of this chapter require, (ii) serve a copy on the chief executive of the municipality in which the waste is to be disposed of or, if the waste is not to be disposed of within a municipality, serve a copy on the chief executive of the county in which the waste is to be disposed of, (iii) make direct distribution of additional copies to Federal, State, Indian Tribe, and local officials in accordance with the requirements of this chapter and written instructions from the Director of Nuclear Material Safety and Safeguards, and (iv) serve a notice of availability of the application and environmental report on the chief executives or governing bodies of the municipalities or counties which have been identified in the application and environmental report as the location of all or part of the alternative sites if copies are not distributed under paragraph (g)(2)(iii) of this section to the executives or bodies. All distributed copies shall be completely assembled documents identified by docket number. Subsequently distributed amendments, however, may include revised pages to previous submittals and, in such cases, the recipients will be responsible for inserting the revised pages. In complying with the requirements of paragraph (g) of this section the applicant shall not make public distribution of those parts of the application subject to § 2.790(d).
(3) The tendered document will be formally docketed upon receipt by the Director of Nuclear Material Safety and Safeguards of the required additional copies. Distribution of the additional copies shall be deemed to be complete as of the time the copies are deposited in the mail or with a carrier prepaid for delivery to the designated addressees. The date of docketing shall be the date when the required copies
(4) Amendments to the application and environmental report shall be filed and distributed and a written statement shall be furnished to the Director of Nuclear Material Safety and Safeguards in the same manner as for the initial application and environmental report.
(5) The Director of Nuclear Material Safety and Safeguards will cause to be published in the
(a) During review of an application by the staff, an applicant may be required to supply additional information. The staff may request any one party to the proceeding to confer with the staff informally. In the case of a docketed application for a construction permit or an operating license for a facility, the staff shall establish a schedule for its review of the application, specifying the key intermediate steps from the time of docketing until the completion of its review.
(b) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will refer the docketed application to the ACRS as required by law and in such additional cases as he or the Commission may determine to be appropriate. The ACRS will render to the Commission one or more reports as required by law or as requested by the Commission.
(c) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will make each report of the ACRS a part of the record of the docketed application, and transmit copies to the appropriate State and local officials.
(d)(1) Except as provided in paragraph (d)(2) of this section, the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will refer and transmit a copy of each docketed application for a construction permit or an operating license for a utilization or production facility under section 103 of the Act to the Attorney General as required by section 105c of the Act.
(2) The requirements of paragraph (d)(1) of this section do not apply to an application for an operating license for a production or utilization facility under section 103 of the Act for which the construction permit was also issued under section 103, unless the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, determines, after consultation with the Attorney General and in accordance with § 2.101(e), that such review is advisable on the ground that significant changes in the licensee's activities or proposed activities have occurred subsequent to the previous review of the Attorney General and the Commission under section 105c of the Act in connection with the construction permit.
(3) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will cause the Attorney General's advice received pursuant to paragraph (d)(1) of this section to be published in the
(a) If the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, finds that an application for a byproduct, source, special nuclear material, or operator license complies with the requirements of the Act, the Energy Reorganization Act, and this chapter, he will issue a license. If the license is for a facility, or for the receipt of waste radioactive material from other persons for the purpose of commercial disposal by the waste disposal licensee, or if it is to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter, the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, will inform the State, Tribal, and local officials specified in § 2.104(e) of the issuance of the license. For notice of issuance requirements for licenses issued pursuant to part 61 of this chapter, see § 2.106(d).
(b) If the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, finds that an application does not comply with the requirements of the Act and this chapter he may issue a notice of proposed denial or a notice of denial of the application and inform the applicant in writing of:
(1) The nature of any deficiencies or the reason for the proposed denial or the denial, and
(2) The right of the applicant to demand a hearing within twenty (20) days from the date of the notice or such longer period as may be specified in the notice.
(a) In the case of an application on which a hearing is required by the Act or this chapter, or in which the Commission finds that a hearing is required in the public interest, the Secretary will issue a notice of hearing to be published in the
(1) The time, place, and nature of the hearing and/or prehearing conference, if any;
(2) The authority under which the hearing is to be held;
(3) The matters of fact and law to be considered; and
(4) The time within which answers to the notice shall be filed.
(b) In the case of an application for a construction permit for a facility on which the Act requires a hearing, the notice of hearing will, except as provided in paragraph (d) of this section and unless the Commission determines otherwise, state, in implementation of paragraph (a)(3) of this section:
(1) That, if the proceeding is a contested proceeding, the presiding officer will consider the following issues:
(i) Whether in accordance with the provisions of § 50.35(a) of this chapter:
(
(
(
(
(ii) Whether the applicant is technically qualified to design and construct the proposed facility;
(iii) Whether the applicant is financially qualified to design and construct the proposed facility;
(iv) Whether the issuance of a permit for the construction of the facility will be inimical to the common defense and security or to the health and safety of the public;
(v) If the application is for a construction permit for a nuclear power reactor, a testing facility, a fuel reprocessing plant, or other facility whose construction or operation has been determined by the Commission to have a significant impact on the environment, whether, in accordance with the requirements of subpart A of part 51 of this chapter, the construction permit should be issued as proposed.
(2) That, if the proceeding is not a contested proceeding, the presiding officer will determine:
(i) Without conducting a de novo evaluation of the application, whether the application and the record of the proceeding contain sufficient information, and the review of the application by the Commission's staff has been adequate to support affirmative findings on (b)(1) (i) through (iii) specified in this section and a negative finding on (b)(1)(iv) specified in this section proposed to be made and the issuance of the construction permit proposed by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, and
(ii) If the application is for a construction permit for a nuclear power reactor, a testing facility, a fuel processing plant, a uranium enrichment facility, or other facility whose construction or operation has been determined by the Commission to have a significant impact on the environment, whether the review conducted by the Commission pursuant to the National Environmental Policy Act (NEPA) has been adequate.
(3) That, regardless of whether the proceeding is contested or uncontested, the presiding officer will, in accordance with subpart A of part 51 of this chapter.
(i) Determine whether the requirements of section 102(2) (A), (C) and (E) of the National Environmental Policy Act and subpart A of part 51 of this chapter have been complied with in the proceeding;
(ii) Independently consider the final balance among conflicting factors contained in the record of the proceeding with a view to determining the appropriate action to be taken; and
(iii) Determine whether the construction permit should be issued, denied, or appropriately conditioned to protect environmental values.
(c) In the case of an application for an operating license in which a hearing will be held, the notice of hearing will, except as provided in paragraph (d) of this section and unless the Commission determines otherwise, state, in implementation of paragraph (a)(3) of this section, that the presiding officer will consider any matters in controversy among the parties and may, where he or she determines that a serious safety, environmental, or common defense and security matter has not been raised by the parties, consider such other matter within the purview of:
(1) Whether there is reasonable assurance that construction of the facility will be substantially completed on a timely basis, in conformity with the construction permit and the application as amended, the provisions of the Act, and the regulations in this chapter;
(2) Whether the facility will operate in conformity with the application as amended, the provisions of the Act, and the regulations in this chapter;
(3) Whether there is reasonable assurance: (i) That the activities to be authorized by the operating license can be conducted without endangering the health and safety of the public, and (ii) that such activities will be conducted in compliance with the regulations in this chapter;
(4) Whether the applicant is technically and financially qualified to engage in the activities to be authorized by the operating license in accordance with the regulations in this chapter, except that the issue of financial qualification shall not be considered by the presiding officer in an operating license hearing if the applicant is an electric utility seeking a license to operate a utilization facility of the type described in § 50.21(b) or § 50.22;
(5) Whether the applicable provisions of part 140 of this chapter have been satisfied;
(6) Whether issuance of the license will be inimical to the common defense and security or to the health and safety of the public; and
(7) If the application is for an operating license for a nuclear power reactor, a testing facility, or a fuel reprocessing plant, or other facility whose operation has been determined by the Commission to have a significant impact on the environment, whether, in accordance with the requirements of subpart A of part 51 of this chapter, the operating license should be issued as proposed.
(d) In an application for a construction permit or an operating license for a facility on which a hearing is required by the Act or this chapter, or in which the Commission finds that a hearing is required in the public interest to consider the antitrust aspects of the application, the notice of hearing will, unless the Commission determines otherwise, state:
(1) A time of the hearing, which will be as soon as practicable after the receipt of the Attorney General's advice
(2) The presiding officer for the hearing who shall be either an administrative law judge or an atomic safety and licensing board established by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel;
(3) That the presiding officer will consider and decide whether the activities under the proposed license would create or maintain a situation inconsistent with the antitrust laws described in section 105a of the Act; and
(4) That matters of radiological health and safety and common defense and security, and matters raised under the National Environmental Policy Act of 1969, will be considered at another hearing if otherwise required or ordered to be held, for which a notice will be published pursuant to paragraphs (a) and (b) of this section, unless otherwise authorized by the Commission.
(e) The Secretary will give timely notice of the hearing to all parties and to other persons, if any, entitled by law to notice. The Secretary will transmit a notice of the hearing on an application for a license for a production or utilization facility, for a license for receipt of waste radioactive material from other persons for the purpose of commercial disposal by the waste disposal licensee, for a license under part 61 of this chapter, for a license to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter, and for a license under part 72 of this chapter to acquire, receive or possess spent fuel for the purpose of storage in an independent spent fuel storage installation (ISFSI) to the governor or other appropriate official of the State and to the chief executive of the municipality in which the facility is to be located or the activity is to be conducted or, if the facility is not to be located or the activity conducted within a municipality, to the chief executive of the county (or to the Tribal organization, if it is to be so located or conducted within an Indian reservation). The Secretary will transmit a notice of hearing on an application for a license under part 72 of this chapter to acquire, receive or possess spent fuel, high-level radioactive waste or radioactive material associated with high-level radioactive waste for the purpose of storage in a monitored retrievable storage installation (MRS) to the same persons who received notice of docketing under § 72.16(e) of this chapter.
For
(a) If a hearing is not required by the Act or this chapter, and if the Commission has not found that a hearing is in the public interest, it will, prior to acting thereon, cause to be published in the
(1) A license for a facility;
(2) A license for receipt of waste radioactive material from other persons for the purpose of commercial disposal by the waste disposal licensee. All licenses issued under part 61 of this chapter shall be so noticed;
(3) An amendment of a license specified in paragraph (a) (1) or (2) of this section and which involves a significant hazards consideration;
(4) An amendment to an operating license for a facility licensed under § 50.21(b) or § 50.22 of this chapter or for a testing facility, as follows:
(i) If the Commission determines under § 50.58 of this chapter that the amendment involves no significant hazards consideration, though it will provide notice of opportunity for ahearing pursuant to this section, it may make the amendment immediately effective and grant a hearing thereafter; or
(ii) If the Commission determines under §§ 50.58 and 50.91 of this chapter that an emergency situation exists or that exigent circumstances exist and that the amendment involves no significant hazards consideration, it will provide notice of opportunity for a hearing pursuant to § 2.106 (if a hearing is requested, it will be held after issuance of the amendment);
(5) A license to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter.
(6) An amendment to a license specified in paragraph (a)(5) of this section, or an amendment to a construction authorization granted in proceedings on an application for such a license, when such an amendment would authorize actions which may significantly affect the health and safety of the public;
(7) A license under part 72 of this chapter to acquire, receive or possess spent fuel for the purpose of storage in an independent spent fuel storage installation (ISFSI) or to acquire, receive or possess spent fuel, high-level radioactive waste or radioactive material associated with high-level radioactive waste for the purpose of storage in a monitored retrievable storage installation (MRS);
(8) An amendment to a license specified in paragraph (a)(7) of this section when such an amendment presents a genuine issue as to whether the health and safety of the public will be significantly affected; or
(9) Any other license or amendment as to which the Commission determines that an opportunity for a public hearing should be afforded;
(10) In the case of an application for an operating license for a facility of a type described in § 50.21(b) or § 50.22 of this chapter or a testing facility, a notice of opportunity for hearing shall be issued as soon as practicable after the application has been docketed; or
(11) In the case of an application for a license to receive and possess high-level radioactive waste at a geologic repository operations area, a notice of opportunity for hearing, as required by this paragraph, shall be published prior to Commission action authorizing receipt of such wastes; this requirement is in addition to the procedures set out in §§ 2.101(f)(8) and 2.104 of this part, which provide for a hearing on the application prior to issuance of a construction authorization.
(b) The notice of proposed action will set forth:
(1) The nature of the action proposed;
(2) The manner in which a copy of the safety analysis and of the ACRS report, if any, may be obtained or examined.
(c) If an application for a license is complete enough to permit all evaluations, other than completion inspection, necessary for the issuance of a construction permit and operating license, the notice of proposed issuance of a construction permit may provide that on completion of construction and inspection the operating license will be issued without further prior notice.
(d) The notice of proposed action will provide that, within thirty (30) days from the date of publication of the notice in the
(1) The applicant may file a request for a hearing; and
(2) Any person whose interest may be affected by the proceeding may file a request for a hearing or a petition for leave to intervene if a hearing has already been requested.
(e)(1) If no request for a hearing or petition for leave to intervene is filed within the time prescribed in the notice, the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, may take the proposed action, inform the appropriate State and local officials, and publish in the
(2) If a request for a hearing or a petition for leave to intervene is filed within the time prescribed in the notice, the presiding officer who shall be an Atomic Safety and Licensing Board established by the Commission or by the
(f) Applications for facility licenses under section 103 of the Act and for facility operating licenses under section 104b of the Act as to which any person intervened or sought by timely written notice to the Commission to intervene in the construction permit proceeding to obtain a determination of antitrust considerations or to advance a jurisdictional basis for such determination are also subject to the provisions of §§ 2.101(b) and 2.102(d).
For
(a) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will cause to be published in the
(1) A license or an amendment of a license for which a notice of proposed action has been previously published; and
(2) An amendment of a license for a facility of the type described in § 50.21(b) or § 50.22 of this chapter, or a testing facility, whether or not a notice of proposed action has been previously published.
(b) The notice of issuance will set forth:
(1) The nature of the license or amendment;
(2) The manner in which copies of the safety analysis, if any, may be obtained and examined; and
(3) A finding that the application for the license or amendment complies with the requirements of the Act and this chapter.
(c) The Director of Nuclear Material Safety and Safeguards will also cause to be published in the
(d) The Director of Nuclear Material Safety and Safeguards will also cause to be published in the
(a) The Commission may permit an applicant to withdraw an application prior to the issuance of a notice of hearing on such terms and conditions as it may prescribe, or may, on receiving a request for withdrawal of an application, deny the application or dismiss it with prejudice. Withdrawal of an application after the issuance of a notice of hearing shall be on such terms as the presiding officer may prescribe.
(b) The withdrawal of an application does not authorize the removal of any document from the files of the Commission.
(c) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will cause to be published in the
(a) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, may deny an application if an applicant fails to respond to a request for additional information within thirty (30) days from the date of the request, or within such other time as may be specified.
(b) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will cause to be published in the
(c) When both a notice of receipt of the application and a notice of hearing have been published, the presiding officer, upon a motion made by the staff pursuant to § 2.730, will rule whether an application should be denied by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, pursuant to paragraph (a).
(a) Except for the renewal of an operating license for a nuclear power plant under 10 CFR 50.21(b) or 50.22, if, at least 30 days prior to the expiration of an existing license authorizing any activity of a continuing nature, the licensee files an application for a renewal or for a new license for the activity so authorized, the existing license will not be deemed to have expired until the application has been finally determined.
(b) If the licensee of a nuclear power plant licensed under 10 CFR 50.21(b) or 50.22 files a sufficient application for renewal of an operating license at least 5 years prior to the expiration of the existing license, the existing license will not be deemed to have expired until the application has been finally determined.
(a)(1) A submittal pursuant to appendix O of part 52 of this chapter shall be subject to §§ 2.101(a) and 2.790 to the same extent as if it were an application for a permit or license.
(2) Except as specifically provided otherwise by the provisions of appendix Q to part 52 of this chapter, a submittal pursuant to appendix Q shall be subject to § 2.101(a) (2) through (4) to the same extent as if it were an application for a permit or license.
(b) Upon initiation of review by the staff of a submittal of a type described in paragraph (a)(1) of this section, the Director of Nuclear Reactor Regulation shall publish in the
(c) Upon completion of review by the NRC staff and the ACRS of a submittal of the type described in paragraph (a)(1) of this section, the Director of the Office of Nuclear Reactor Regulation shall publish in the
No person shall on the ground of sex be excluded from participation in, be denied a license under, be denied the benefits of, or be subjected to discrimination under any program or activity
(a) This subpart prescribes the procedures in cases initiated by the staff, or upon a request by any person, to impose requirements by order, or to modify, suspend, or revoke a license, or to take other action as may be proper, against any person subject to the jurisdiction of the Commission. However, with regard to the holder of a part 76 certificate of compliance or compliance plan, except for civil penalty procedures in this subpart, the applicable procedures are set forth in § 76.70 of this chapter.
(b) This subpart also prescribes the procedures in cases initiated by the staff to impose civil penalties pursuant to section 234 of the Act and section 206 of the Energy Reorganization Act of 1974.
(a) In response to an alleged violation of any provision of the Act or this chapter or the conditions of a license or an order issued by the Commission, the Commission may serve on the licensee or other person subject to the jurisdiction of the Commission a written notice of violation; a separate notice may be omitted if an order pursuant to § 2.202 or demand for information pursuant to § 2.204 is issued that otherwise identifies the apparent violation. The notice of violation will concisely state the alleged violation and may require that the licensee or other person submit, within 20 days of the date of the notice or other specified time, a written explanation or statement in reply if the Commission believes that the licensee has not already addressed all the issues contained in the notice of violation, including:
(1) Corrective steps which have been taken by the licensee or other person and the results achieved;
(2) Corrective steps which will be taken; and
(3) The date when full compliance will be achieved.
(b) The notice may require the licensee or other person subject to the jurisdiction of the Commission to admit or deny the violation and to state the reasons for the violation, if admitted. It may provide that, if an adequate reply is not received within the time specified in the notice, the Commission may issue an order or a demand for information as to why the license should not be modified, suspended or revoked or why such other action as may be proper should not be taken.
(a) The Commission may institute a proceeding to modify, suspend, or revoke a license or to take such other action as may be proper by serving on the licensee or other person subject to the jurisdiction of the Commission an order that will:
(1) Allege the violations with which the licensee or other person subject to the Commission's jurisdiction is charged, or the potentially hazardous conditions or other facts deemed to be sufficient ground for the proposed action, and specify the action proposed;
(2) Provide that the licensee or other person must file a written answer to the order under oath or affirmation within twenty (20) days of its date, or such other time as may be specified in the order;
(3) Inform the licensee or any other person adversely affected by the order of his or her right, within twenty (20) days of the date of the order, or such other time as may be specified in the order, to demand a hearing on all or part of the order, except in a case where the licensee or other person has consented in writing to the order;
(4) Specify the issues for hearing; and
(5) State the effective date of the order; if the Commission finds that the
(b) A licensee or other person to whom the Commission has issued an order under this section must respond to the order by filing a written answer under oath or affirmation. The answer shall specifically admit or deny each allegation or charge made in the order, and shall set forth the matters of fact and law on which the licensee or other person relies, and, if the order is not consented to, the reasons as to why the order should not have been issued. Except as provided in paragraph (d) of this section, the answer may demand a hearing.
(c) If the answer demands a hearing, the Commission will issue an order designating the time and place of hearing.
(1) If the answer demands a hearing with respect to an immediately effective order, the hearing will be conducted expeditiously, giving due consideration to the rights of the parties.
(2) (i) The licensee or other person to whom the Commission has issued an immediately effective order may, in addition to demanding a hearing, at the time the answer is filed or sooner, move the presiding officer to set aside the immediate effectiveness of the order on the ground that the order, including the need for immediate effectiveness, is not based on adequate evidence but on mere suspicion, unfounded allegations, or error. The motion must state with particularity the reasons why the order is not based on adequate evidence and must be accompanied by affidavits or other evidence relied on. The NRC staff shall respond within (5) days of the receipt of the motion. The motion must be decided by the presiding officer expeditiously. During the pendency of the motion or at any other time, the presiding officer may not stay the immediate effectiveness of the order, either on its own motion, or upon motion of the licensee or other person. The presiding officer will uphold the immediate effectiveness of the order if it finds that there is adequate evidence to support immediate effectiveness. An order upholding immediate effectiveness will constitute the final agency action on immediate effectiveness. An order setting aside immediate effectiveness will be referred promptly to the Commission itself and will not be effective pending further order of the Commission.
(ii) The presiding officer may, on motion by the staff or any other party to the proceeding, where good cause exists, delay the hearing on the immediately effective order at any time for such periods as are consistent with the due process rights of the licensee and other affected parties.
(d) An answer may consent to the entry of an order in substantially the form proposed in the order with respect to all or some of the actions proposed in the order. The consent, in the answer or other written document, of the licensee or other person to whom the order has been issued to the entry of an order shall constitute a waiver by the licensee or other person of a hearing, findings of fact and conclusions of law, and of all right to seek Commission and judicial review or to contest the validity of the order in any forum as to those matters which have been consented to or agreed to or on which a hearing has not been requested. An order that has been consented to shall have the same force and effect as an order made after hearing by a presiding officer or the Commission, and shall be effective as provided in the order.
(e) If the order involves the modification of a part 50 license and is a backfit, the requirements of § 50.109 of this chapter shall be followed, unless the licensee has consented to the action required.
At any time after the issuance of an order designating the time and place of hearing in a proceeding to modify, suspend, or revoke a license or for other action, the staff and a licensee or other person may enter into a stipulation for the settlement of the proceeding or the compromise of a civil penalty. The stipulation or compromise shall be subject to approval by the designated presiding officer or, if none has been designated, by the Chief Administrative
(a) The Commission may issue to a licensee or other person subject to the jurisdiction of the Commission a demand for information for the purpose of determining whether an order under § 2.202 should be issued, or whether other action should be taken, which demand will:
(1) Allege the violations with which the licensee or other person is charged, or the potentially hazardous conditions or other facts deemed to be sufficient ground for issuing the demand; and
(2) Provide that the licensee must, or the other person may, file a written answer to the demand for information under oath or affirmation within twenty (20) days of its date, or such other time as may be specified in the demand for information.
(b) A licensee to whom the Commission has issued a demand for information under this section must respond to the demand by filing a written answer under oath or affirmation; any other person to whom the Commission has issued a demand for information may, in its discretion, respond to the demand by filing a written answer under oath or affirmation. The licensee's answer shall specifically admit or deny each allegation or charge made in the demand for information, and shall set forth the matters of fact and law on which the licensee relies. A person other than a licensee may answer as described above, or by setting forth its reasons why the demand should not have been issued and, if the requested information is not provided, the reasons why it is not provided.
(c) Upon review of the answer filed pursuant to paragraph (a)(2) of this section, or if no answer is filed, the Commission may institute a proceeding pursuant to 10 CFR 2.202 to take such action as may be proper.
(d) An answer may consent to the entry of an order pursuant to § 2.202 in substantially the form proposed in the demand for information. Such consent shall constitute a waiver as provided in § 2.202(d).
(a) Before instituting any proceeding to impose a civil penalty under section 234 of the Act, the Executive Director for Operations or the Executive Director's designee, as appropriate, shall serve a written notice of violation upon the person charged. This notice may be included in a notice issued pursuant to § 2.201 or § 76.70(d) of this chapter. The notice of violation shall specify the date or dates, facts, and the nature of the alleged act or omission with which the person is charged, and shall identify specifically the particular provision or provisions of the law, rule, regulation, license, permit, part 76 certificate of compliance or compliance plan, or cease and desist order involved in the alleged violation and must state the amount of each proposed penalty. The notice of violation shall also advise the person charged that the civil penalty may be paid in the amount specified therein, or the proposed imposition of the civil penalty may be protested in its entirety or in part, by a written answer, either denying the violation or showing extenuating circumstances. The notice of violation shall advise the person charged that upon failure to pay a civil penalty subsequently determined by the Commission, if any, unless compromised, remitted, or mitigated, be collected by civil action, pursuant to Section 234c of the Act.
(b) Within twenty (20) days of the date of a notice of violation or other time specified in the notice, the person charged may either pay the penalty in the amount proposed or answer the notice of violation. The answer to the notice of violation shall state any facts, explanations, and arguments, denying the charges of violation, or demonstrating any extenuating circumstances, error in the notice of violation, or other reason why the penalty
(c) If the person charged with violation fails to answer within the time specified in paragraph (b) of this section, an order may be issued imposing the civil penalty in the amount set forth in the notice of violation described in paragraph (a) of this section.
(d) If the person charged with violation files an answer to the notice of violation, the Executive Director for Operations or the Executive Director's designee, upon consideration of the answer, will issue an order dismissing the proceeding or imposing, mitigating, or remitting the civil penalty. The person charged may, within twenty (20) days of the date of the order or other time specified in the order, request a hearing.
(e) If the person charged with violation requests a hearing, the Commission will issue an order designating the time and place of hearing.
(f) If a hearing is held, an order will be issued after the hearing by the presiding officer or the Commission dismissing the proceeding or imposing, mitigating, or remitting the civil penalty.
(g) The Executive Director for Operations or the Executive Director's designee, as appropriate may compromise any civil penalty, subject to the provisions of § 2.203.
(h) If the civil penalty is not compromised, or is not remitted by the Executive Director for Operations or the Executive Director's designee, as appropriate, the presiding officer, or the Commission, and if payment is not made within ten (10) days following either the service of the order described in paragraph (c) or (f) of this section, or the expiration of the time for requesting a hearing described in paragraph (d) of this section, the Executive Director for Operations or the Executive Director's designee, as appropriate, may refer the matter to the Attorney General for collection.
(i) Except when payment is made after compromise or mitigation by the Department of Justice or as ordered by a court of the United States, following reference of the matter to the Attorney General for collection, payment of civil penalties imposed under Section 234 of the Act are to be made payable to the U.S. Nuclear Regulatory Commission, in U.S. funds, by check, draft, money order, credit cars, or electronic funds transfer such as Automated Clearing House (ACH) using Electronic Data Interchange (EDI). Federal agencies may also make payment by the On-Line Payment and Collections System (OPAC's). All payments are to be made in accordance with the specific payment instructions provided with Notices of Violation that propose civil penalties and Orders Imposing Civil Monetary Penalties.
(j)
(a) Any person may file a request to institute a proceeding pursuant to § 2.202 to modify, suspend, or revoke a license, or for any other action as may be proper. Requests must be addressed to the Executive Director for Operations and must be filed either by delivery to the NRC Public Document Room at 2120 L Street, NW., Washington, DC, or by mail or telegram addressed to the Executive Director for Operations, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The request must specify the action requested and set forth the facts that constitute the basis for the request. The Executive Director for Operations will refer the request to the Director of the NRC office with responsibility for the subject matter of the request for appropriate action in accordance with paragraph (b) of this section.
(b) Within a reasonable time after a request pursuant to paragraph (a) of this section has been received, the Director of the NRC office with responsibility for the subject matter of the request shall either institute the requested proceeding in accordance with this subpart or shall advise the person who made the request in writing that no proceeding will be instituted in whole or in part, with respect to the request, and the reasons for the decision.
(c)(1) Director's decisions under this section will be filed with the Office of the Secretary. Within twenty-five (25) days after the date of the Director's decision under this section that no proceeding will be instituted or other action taken in whole or in part, the Commission may on its own motion review that decision, in whole or in part, to determine if the Director has abused his discretion. This review power does not limit in any way either the Commission's supervisory power over delegated staff actions or the Commission's power to consult with the staff on a formal or informal basis regarding institution of proceedings under this section.
(2) No petition or other request for Commission review of a Director's decision under this section will be entertained by the Commission.
This subpart describes procedures applicable to licensing proceedings which involve the consideration in hearings of a number of applications, filed by one or more applicants pursuant to appendix N of part 52 of this chapter, for licenses to construct and operate nuclear power reactors of essentially the same design to be located at different sites.
(a) In the case of applications pursuant to appendix N of part 52 of this chapter for construction permits for nuclear power reactors of the type described in § 50.22 of this chapter, the Secretary will issue notices of hearing pursuant to § 2.104.
(b) The notice of hearing will also state the time and place of the hearings on any separate phase of the proceeding.
(a) In the case of applications pursuant to appendix N of part 52 of this chapter for construction permits for nuclear power reactors of a type described in § 50.22 of this chapter, the Commission or the presiding officer may order separate hearings on particular phases of the proceeding, such as matters related to the acceptability of the design of the reactor, in the context of the site parameters postulated for the design; environmental matters; or antitrust aspects of the application.
(b) If a separate hearing is held on a particular phase of the proceeding, the Commission or presiding officers of each affected proceeding may, pursuant to § 2.716, consolidate for hearing on that phase two or more proceedings to consider common issues relating to the applications involved in the proceedings, if it finds that such action will be conducive to the proper dispatch of its business and to the ends of justice. In fixing the place of any such consolidated hearing due regard will be given to the convenience and necessity of the parties, petitioners for leave to
In the case of applications pursuant to appendix N of part 52 of this chapter for operating licenses for nuclear power reactors, if the Commission has not found that a hearing is in the public interest, the Director of Nuclear Reactor Regulation will, prior to acting thereon, cause to be published in the
If a request for a hearing and/or petition for leave to intervene is filed within the time prescribed in the notice of proposed action on an application for an operating license pursuant to appendix N of part 52 of this chapter with respect to a specific reactor(s) at a specific site and the Commission or an atomic safety and licensing board designated by the Commission or by the Chairman of the Atomic Safety and Licensing Board Panel has issued a notice of hearing or other appropriate order, the Commission or the atomic safety and licensing board may order separate hearings on particular phases of the proceeding and/or consolidate for hearing two or more proceedings in the manner described in § 2.402.
At the conclusion of any hearing held pursuant to this subpart, the presiding officer will render a partial initial decision which may be appealed pursuant to § 2.762. No construction permit or full power operating license will be issued until an initial decision has been issued on all phases of the hearing and all issues under the Act and the National Environmental Policy Act of 1969 appropriate to the proceeding have been resolved.
Notwithstanding any other provision of this chapter, in a proceeding conducted pursuant to this subpart and appendix N of part 52 of this chapter, no matter which has been reserved for consideration in one phase of the hearing shall be considered at another phase of the hearing except on the basis of significant new information that substantially affects the conclusion(s) reached at the other phase or other good cause.
The provisions of subparts A and G relating to construction permits and operating licenses apply, respectively, to construction permits and operating licenses subject to this subpart, except as qualified by the provisions of this subpart.
This subpart prescribes procedures applicable to licensing proceedings which involve the consideration in separate hearings of an application for a license to manufacture nuclear power reactors pursuant to appendix M of part 52 of this chapter, and applications for construction permits and operating licenses for nuclear power reactors which have been the subject of such an application for a license to
(a) In the case of an application pursuant to appendix M of part 52 of this chapter for a license to manufacture nuclear power reactors of the type described in § 50.22 of this chapter to be operated at sites not identified in the license application, the Secretary will issue a notice of hearing to be published in the
(1) The time, place, and nature of the hearing and/or the prehearing conference;
(2) The authority within which the hearing is to be held;
(3) The matters of fact and law to be considered; and
(4) The time within which answers to the notice shall be filed.
(b) The issues stated in the notice of hearing pursuant to paragraph (a) of this section will not involve consideration of the particular sites at which any of the nuclear power reactors to be manufactured will be located and operated. Except as the Commission determines otherwise, the notice of hearing will state:
(1) That, if the proceeding is a contested proceeding, the presiding officer will consider the following issues:
(i) Whether the applicant has described the proposed design of, and the site parameters postulated for, the reactor(s), including, but not limited to, the principal architectural and engineering criteria for the design, and has identified the major features or components incorporated therein for the protection of the health and safety of the public;
(ii) Whether such further technical or design information as may be required to complete the design report and which can reasonably be left for later consideration, will be supplied in a supplement to the design report;
(iii) Whether safety features or components, if any, which require research and development have been described by the applicant and the applicant has identified, and there will be conducted a research and development program reasonably designed to resolve any safety questions associated with such features or components;
(iv) Whether on the basis of the foregoing, there is reasonable assurance that (A) such safety questions will be satisfactorily resolved before any of the proposed nuclear power reactors are removed from the manufacturing site, and (B) taking into consideration the site criteria contained in part 100 of this chapter, the proposed reactor(s) can be constructed and operated at sites having characteristics that fall within the site parameters postulated for the design of the reactor(s) without undue risk to the health and safety of the public;
(v) Whether the applicant is technically and financially qualified to design and manufacture the proposed reactor(s);
(vi) Whether the issuance of a license for manufacture of the reactor(s) will be inimical to the common defense and security or to the health and safety of the public; and
(vii) Whether, in accordance with the requirements of subpart A of part 51 and appendix M of part 52 of this chapter, the license should be issued as proposed.
(2) That, if the proceeding is not a contested proceeding, the presiding officer will determine (i) without conducting a de novo evaluation of the application, whether the application and the record of the proceeding contain sufficient information, and the review of the application by the Commission's staff has been adequate to support affirmative findings on paragraphs (b)(1) (i) through (v) of this section and a
(3) That, regardless of whether the proceeding is contested or uncontested, the presiding officer will, in accordance with subpart A of part 51 and paragraph 3 of appendix M of part 52 of this chapter,
(i) Determine whether the requirements of section 102(2) (A), (C) and (E) of the National Environmental Policy Act and subpart A of part 51 of this chapter have been complied with in the proceeding;
(ii) Independently consider the final balance among conflicting factors contained in the record of the proceeding with a view to determining the appropriate action to be taken; and
(iii) Determine whether the manufacturing license should be issued, denied or appropriately conditioned to protect environmental values.
(c) The place of hearing on an application for a manufacturing license will be Washington, DC, or such other location as the Commission deems appropriate.
The issues stated for consideration in the notice of hearing on an application for a permit to construct a nuclear power reactor(s) which is the subject of an application for a manufacturing license pursuant to appendix M of part 52 of this chapter, will be those stated in § 2.104(b) and, in addition, whether the site on which the facility is to be operated falls within the postulated site parameters specified in the relevant application for a manufacturing license.
Notwithstanding any other provision of this chapter, no matter which has been resolved at an earlier stage of the licensing process which involves a manufacturing license, a permit to construct a reactor for which a manufacturing license is sought, a license to operate such a reactor, and any amendment to such permit or licenses shall be determined to be at issue in any subsequent state of the licensing process except on the basis of significant new information that substantially affects the conclusion(s) reached at the earlier stage or other good cause.
The provisions of subparts A and G relating to construction permits apply to manufacturing licenses subject to this subpart, with respect to matters of radiological health and safety, environmental protection, and the common defense and security, except that § 2.104 (a) and (b) do not apply to manufacturing licenses. The provisions of subparts A and G relating to construction permits and operating licenses apply, respectively, to construction permits and operating licenses subject to this subpart, except as qualified by the provisions of this subpart.
This subpart prescribes procedures applicable to licensing proceedings which involve an early submittal of site suitability information in accordance with § 2.101(a-1), and a hearing and early partial decision on issues of site
The provisions of subparts A and G relating to applications for construction permits and proceedings thereon apply, respectively, to aplications and proceedings in accordance with this subpart, except as specifically provided otherwise by the provisions of this subpart.
Each application which contains a request for early review of site suitability issues under the procedures of this subpart shall be accompanied by any fee required by § 50.30(e) and part 170 of this chapter.
(a) Each part of an application submitted in accordance with § 2.101(a-1) of this part will be initially treated as a tendered application. If it is determined that any one of the parts as described in § 2.101(a-1) is incomplete and not acceptable for processing, the Director of Nuclear Reactor Regulation will inform the applicant of this determination and the respects in which the document is deficient. Such a determination of completeness will generally be made within a period of thirty (30) days.
(b)(1) The Director of Nuclear Reactor Regulation will accept for docketing an application for a construction permit for a utilization facility which is subject to § 51.20(b) of this chapter and is of the type specified in § 50.21(b) (2) or (3) or § 50.22 or is a testing facility where part one of the application as described in § 2.101(a-1) is complete. Part one of any application will not be considered complete unless it contains proposed findings as required by § 2.101(a-1)(1)(i) and unless it describes the applicant's site selection process, specifies the extent to which that process involves the consideration of alternative sites, explains the relationship between that process and the application for early review of site suitability issues, and briefly describes the applicant's long-range plans for ultimate development of the site. Upon assignment of a docket number, the procedures in § 2.101(a) (3) and (4) relating to formal docketing and the submission and distribution of additional copies of the application shall be followed.
(2) Additional parts of the application will be docketed upon a determination by the Director of Nuclear Reactor Regulation that they are complete.
(c) If part one of the application is docketed, the Director of Nuclear Reactor Regulation will cause to be published in the
(a) Where an applicant for a construction permit for a utilization facility subject to this subpart requests an early review and hearing and an early partial decision on issues of site suitability pursuant to § 2.101(a-1), the provisions in the notice of hearing setting
(b) After docketing of part two of the application, as provided in §§ 2.101(a-1) and 2.603, a supplementary notice of hearing will be published pursuant to § 2.104 with respect to the remaining unresolved issues in the proceeding within the scope of § 2.104. Such supplementary notice of hearing will provide that any person whose interest may be affected by the proceeding and who desires to participate as a party in the resolution of the remaining issues shall file a petition for leave to intervene pursuant to § 2.714 within the time prescribed in the notice. Such supplementary notice will also provide appropriate opportunities for participation by a representative of an interested state under § 2.715(c) and for limited appearances pursuant to § 2.715(a).
(c) Any person who was permitted to intervene as a party pursuant to the initial notice of hearing on site suitability issues and who was not dismissed or did not withdraw as a party may continue to participate as a party to the proceeding with respect to the remaining unresolved issues, provided that within the time prescribed for filing of petitions for leave to intervene in the supplementary notice of hearing, he files a notice of his intent to continue as a party, along with a supporting affidavit identifying the specific aspect or aspects of the subject matter of the proceeding as to which he wishes to continue to participate as a party and setting forth with particularity the basis for his contentions with regard to each such aspect or aspects. A party who files a non-timely notice of intent to continue as a party may be dismissed from the proceeding, absent a determination that the party has made a substantial showing of good cause for failure to file on time, and with particular reference to the factors specified in §§ 2.714(a) (1) through (4) and 2.714(d). The notice will be ruled upon by the Commission or atomic safety and licensing board designated to rule on petitions for leave to intervene.
(d) To the maximum extent practicable, the membership of the atomic safety and licensing board designated to preside in the proceeding on the remaining unresolved issues pursuant to the supplemental notice of hearing will be the same as the membership designated to preside in the initial notice of hearing on site suitability issues.
(a) The Commission will not conduct more than one review of site suitability issues with regard to a particular site prior to filing and review of part two of the application described in § 2.101(a-1) of this part.
(b) The Commission, upon its own initiative, or upon the motion of any party to the proceeding filed at least sixty (60) days prior to the date of the commencement of the evidentiary hearing on site suitability issues, may decline to initiate an early hearing or render an early partial decision on any issue or issues of site suitability:
(1) In cases where no partial decision on the relative merits of the proposed site and alternative sites under subpart A of part 51 is requested, upon determination that there is a reasonable likelihood that further review would identify one or more preferable alternative sites and the partial decision on one or more site suitability issues would lead to an irreversible and irretrievable commitment of resources prior to the submittal of the remainder of the information required by § 50.30(f) of this chapter that would prejudice the later review and decision on such alternative sites; or
(2) In cases where it appears that an early partial decision on any issue or issues of site suitability would not be in the public interest considering (i) the degree of likelihood that any early findings on those issues would retain their validity in later reviews, (ii) the objections, if any, of cognizant state or local government agencies to the conduct of an early review on those issues, and (iii) the possible effect on the public interest and the parties of having an early, if not necessarily conclusive, resolution of those issues.
(a) The provisions of §§ 2.754, 2.755, 2.760, 2.761, 2.762, 2.763, and 2.764(a) shall apply to any partial initial decision rendered in accordance with this subpart. Section 2.764(b) shall not apply to any partial initial decision rendered in accordance with this subpart. No limited work authorization may be issued pursuant to § 50.10(e) of part 50 of this chapter and no construction permit may be issued without completion of the full review required by section 102(2) of the National Environmental Policy Act of 1969, as amended, and subpart A of part 51 of this chapter. The authority of the Commission to review such a partial initial decision
(b)(1) A partial decision on one or more site suitability issues pursuant to the applicable provisions of part 50, subpart A of part 51, and part 100 of this chapter issued in accordance with this subpart shall (i) clearly identify the site to which the partial decision applies and (ii) indicate to what extent additional information may be needed and additional review may be required to enable the Commission to determine in accordance with the provisions of the Act and the applicable provisions of the regulations in this chapter whether a construction permit for a facility to be located on the site identified in the partial decision should be issued or denied.
(2) Following completion of Commission review of the partial initial decision of the Atomic Safety and Licensing Board, after hearing, on the site suitability issues, the partial decision shall remain in effect either for a period of five years or, where the applicant for the construction permit has made timely submittal of the information required to support the application as provided in § 2.101(a-1), until the proceeding for a permit to construct a facility on the site identified in the partial decision has been concluded,
The general rules in this subpart govern procedure in all adjudications initiated by the issuance of an order pursuant to § 2.202, an order pursuant to § 2.205(e), a notice of hearing, a notice of proposed action issued pursuant to § 2.105, or a notice issued pursuant to § 2.102(d)(3). The procedures applicable to the proceeding on an application for a license to receive and possess high-level radioactive waste at a geologic repository operations area are set forth in subpart J.
(a) Consistent with 5 U.S.C. 554(a)(4) of the Administrative Procedure Act, the Commission may provide alternative procedures in adjudications to the extent that there is involved the conduct of military or foreign affairs functions.
(b) This rule shall apply to proceedings in progress where hearings have already been requested or ordered as well as to future proceedings.
(a) Documents shall be filed with the Commission in adjudications subject to this part either:
(1) By delivery to the NRC Public Document Room at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland 20852-2738, or
(2) By mail or addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.
(b) All documents offered for filing shall be accompanied by proof of service upon all parties to the proceeding or their attorneys of record as required by law or by rule or order of the Commission. The staff of the Commission shall be deemed to be a party.
(c) Filing by mail, telegram, or facsimile will be deemed to be complete as of the time of deposit in the mail or with a telegraph company or upon facsimile transmission.
The Secretary shall maintain a docket for each proceeding subject to this part, commencing with the issuance of the initial notice of hearing, notice of consideration of issuance of facility operating license or other proposed action specified in § 2.105, or order. The Secretary shall maintain all files and records, including the transcripts of testimony and exhibits and all papers, correspondence, decisions and orders filed or issued.
(a) In a proceeding in which the terms of a notice of hearing are not otherwise prescribed by this part, the order or notice of hearing will state:
(1) The nature of the hearing, and its time and place, or a statement that the time and place will be fixed by subsequent order;
(2) The legal authority and jurisdiction under which the hearing is to be held;
(3) The matters of fact and law asserted or to be considered; and
(4) The time within which an answer shall be filed.
(b) The time and place of hearing will be fixed with due regard for the convenience of the parties or their representatives, the nature of the proceeding, and the public interest.
(a) The Commission may provide in the notice of hearing that one or more members of the Commission, or an atomic safety and licensing board, or a named officer who has been delegated final authority in the matter, shall preside. If the Commission does not so provide, the Chairman of the Atomic Safety and Licensing Board Panel will issue an order designating an atomic safety and licensing board appointed pursuant to section 191 of the Atomic Energy Act of 1954, as amended, or, if the Commission has not provided for the hearing to be conducted by an atomic safety and licensing board, the Chief Administrative Law Judge will issue an order designating an administrative law judge appointed pursuant to section 3105 of title 5 of the United States Code.
(b) If a designated presiding officer or a designated member of an atomic safety and licensing board deems himself disqualified to preside or to participate as a board member in the hearing, he shall withdraw by notice on the record and shall notify the Commission or the Chairman of the Atomic Safety and Licensing Board Panel, as appropriate, of his withdrawal.
(c) If a party deems the presiding officer or a designated member of an atomic safety and licensing board to be disqualified, he may move that the presiding officer or the board member disqualify himself. The motion shall be supported by affidavits setting forth the alleged grounds for disqualification. If the presiding officer does not grant the motion or the board member does not disqualify himself, the motion shall be referred to the Commission
(d) If a presiding officer or a designated member of an atomic safety and licensing board becomes unavailable during the course of a hearing, the Commission or the Chairman of the Atomic Safety and Licensing Board Panel, as appropriate, will designate another presiding officer or atomic safety and licensing board member. If he becomes unavailable after the hearing has been concluded:
(1)(i) The Commission may designate another presiding officer to make the decision; or
(ii) The Chairman of the Atomic Safety and Licensing Board Panel or the Commission, as appropriate, may designate another atomic safety and licensing board member to participate in the decision;
(2) The Commission may direct that the record be certified to it for decision; or
(3) The Commission may designate another presiding officer.
(e) In the event of substitution of a presiding officer or a designated member of an atomic safety and licensing board for the one originally designated, any motion predicated upon the substitution shall be made within five (5) days thereafter.
(a) Within twenty (20) days after service of the notice of hearing, or such other time as may be specified in the notice of hearing, a party may file an answer which shall concisely state:
(1) The nature of his defense or other position;
(2) The items of the specification of issues he controverts and those he does not controvert; and
(3) Whether he proposes to appear and present evidence.
(b) If facts are alleged in the specification of issues, the answer shall admit or deny specifically each material allegation of fact; or, where the party has no knowledge or information sufficient to form a belief, the answer may so state and the statement shall have the effect of a denial. Material allegations of fact not denied shall be deemed to be admitted. Matters alleged as affirmative defenses or positions shall be separately stated and identified and, in the absence of a reply, shall be deemed to be controverted.
(c) If a party does not oppose an order or proposed action embodied in or accompanying the notice of hearing, or does not wish to appear and present evidence at the hearing, the answer shall so state. In lieu of appearing at the hearing, a party may request leave to file a statement under oath or affirmation of reasons why the proposed order or action should not be issued or should differ from that proposed. Such a statement, if accepted, will be accorded whatever weight is deemed proper.
A party may file a reply to an answer within ten (10) days after it is served.
On failure of a party to file an answer or pleading within the time prescribed in this part or as specified in the notice of hearing or pleading; to appear at a hearing or prehearing conference, to comply with any prehearing order entered pursuant to § 2.751a or § 2.752, or to comply with any discovery order entered by the presiding officer pursuant to § 2.740, the Commission or the presiding officer
(a) Without further notice, find the facts as to the matters regarding which the order was made in accordance with the claim of the party obtaining the order, and enter such order as may be appropriate; or
(b) Proceed without further notice to take proof on the issues specified.
(a) Each document filed in an adjudication subject to this part to which a docket number has been assigned shall bear the docket number and title of the proceeding.
(b) Each document shall be bound on the left side and typewritten, printed or otherwise reproduced in permanent form on good unglazed paper of standard letterhead size. Each page shall begin not less than one and one-quarter inches from the top, with side and bottom margins of not less than one and one-quarter inches. Text shall be double-spaced, except that quotations may be single-spaced and indented. The requirements of this paragraph do not apply to original documents or admissible copies offered as exhibits, or to specially prepared exhibits.
(c) The original of each document shall be signed in ink by the party or his authorized representative, or by an attorney having authority with respect to it. The capacity of the person signing, his address, and the date shall be stated. The signature of a person signing in a representative capacity is a representation that the document has been subscribed in the capacity specified with full authority, that he has read it and knows the contents, that to the best of his knowledge, information, and belief the statements made in it are true, and that it is not interposed for delay. If a document is not signed, or is signed with intent to defeat the purpose of this section, it may be stricken.
(d) Except as otherwise provided by this part or by order, a pleading (or other document) other than correspondence shall be filed in an original and two conformed copies.
(e) The first document filed by any person in a proceeding shall designate the name and address of a person on whom service may be made.
(f) A document filed by telegraph need not comply with the formal requirements of paragraphs (b), (c), and (d) of this section if an original and copies otherwise complying with all of the requirements of this section are mailed within two (2) days thereafter to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.
A document which fails to conform to the requirements of § 2.708 may be refused acceptance for filing and may be returned with an indication of the reason for nonacceptance. Any matter so tendered but not accepted for filing shall not be entered on the Commission's docket.
In computing any period of time, the day of the act, event, or default after which the designated period of time begins to run is not included. The last day of the period so computed is included unless it is a Saturday, Sunday, or legal holiday at the place where the action or event is to occur, in which event the period runs until the end of the next day which is neither a Saturday, Sunday, nor holiday. Whenever a party has the right or is required to do some act within a prescribed period after the service of a notice or other paper upon him or her and the notice or paper is served upon by mail, five (5) days shall be added to the prescribed period. Only two (2) days shall be added when a document is served by express mail.
(a) Except as otherwise provided by law, whenever an act is required or allowed to be done at or within a specified time, the time fixed or the period of time prescribed may for good cause be extended or shortened by the Commission or the presiding officer, or by stipulation approved by the Commission or the presiding officer.
(b) In any instance in which this part does not prescribe a time limit for an action to be taken in the proceeding, the Commission or the presiding officer may set a time limit for that action.
(a)
(b)
(c)
(d)
(2) When pleadings are personally delivered to tribunals while they are conducting proceedings outside the Washington, DC area, service on the Secretary may be accomplished by overnight mail.
(3) Service of pre-filed testimony and demonstrative evidence (
(4) The addresses for the Secretary are:
(i) First class mail: Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.
(ii) Express mail: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemakings and Adjudications Staff.
(iii) Facsimile: (301) 415-1101, verification number is (301) 415-1966; and e-mail: SECY@NRC.gov.
(e)
(1) By personal delivery, on handing the paper to the individual, or leaving it at his office with his clerk or other person in charge or, if there is no one in charge, leaving it in a conspicuous place therein or, if the office is closed or the person to be served has no office, leaving it at his usual place of residence with some person of suitable age and discretion then residing there;
(2) By telegraph, when deposited with a telegraph company, properly addressed and with charges prepaid;
(3) By mail, on deposit in the United States mail, properly stamped and addressed; or
(4) When service cannot be effected in a manner provided by paragraphs (d) (1) to (3) inclusive of this section in any other manner authorized by law.
(f)
(1) Written acknowledgment of the party served or his counsel;
(2) The certificate of counsel if he has made the service; or
(3) The affidavit of the person making the service.
(g)
(a)
(b)
(c)
(2) A reprimand, a censure or a suspension which is ordered to run for one day or less shall be ordered with grounds stated on the record of the proceeding and shall advise the person disciplined of the right to appeal pursuant to paragraph (c)(3) of this section. A suspension which is ordered for a longer period shall be in writing, shall state the grounds on which it is based, and shall advise the person suspended of the right to appeal and to request a stay pursuant to paragraphs (c)(3) and (c)(4) of this section. A proceeding may be stayed for a reasonable time in order for an affected party to obtain other representation if this would be necessary to prevent injustice.
(3) Anyone disciplined pursuant to this section may within ten (10) days after issuance of the order file an appeal with the Commission. The appeal shall be in writing and state concisely, with supporting argument, why the appellant believes the order was erroneous, either as a matter of fact or law. The Commission shall consider each appeal on the merits, including appeals in cases in which the suspension period has already run. If necessary for a full and fair consideration of the facts, the Commission may conduct further evidentiary hearings, or may refer the matter to another presiding officer for development of a record. In the latter event, unless the Commission provides specific directions to the presiding officer, that officer shall determine the procedure to be followed and who shall present evidence, subject to applicable provisions of law. Such hearing shall commence as soon as possible. In the case of an attorney, if no appeal is taken of a suspension, or, if the suspension is upheld at the conclusion of the appeal, the presiding officer, or the Commission, as appropriate, shall notify the state bar(s) to which the attorney is admitted. Such notification shall include copies of the order of suspension, and, if an appeal was taken, briefs of the parties, and the decision of the Commission.
(4) A suspension exceeding 1 day shall not be effective for 72 hours from the
(a)(1) Any person whose interest may be affected by a proceeding and who desires to participate as a party shall file a written petition for leave to intervene. In a proceeding noticed pursuant to § 2.105, any person whose interest may be affected may also request a hearing. The petition and/or request shall be filed not later than the time specified in the notice of hearing, or as provided by the Commission, the presiding officer or the Atomic Safety and Licensing Board designated to rule on the petition and/or request, or as provided in § 2.102(d)(3). Nontimely filings will not be entertained absent a determination by the Commission, the presiding officer or the Atomic Safety and Licensing Board designated to rule on the petition and/or request, that the petition and/or request should be granted based upon a balancing of the following factors in addition to those set out in paragraph (d)(1) of this section:
(i) Good cause, if any, for failure to file on time.
(ii) The availability of other means whereby the petitioner's interest will be protected.
(iii) The extent to which the petitioner's participation may reasonably be expected to assist in developing a sound record.
(iv) The extent to which the petitioner's interest will be represented by existing parties.
(v) The extent to which the petitioner's participation will broaden the issues or delay the proceeding.
(2) The petition shall set forth with particularity the interest of the petitioner in the proceeding, how that interest may be affected by the results of the proceeding, including the reasons why petitioner should be permitted to intervene, with particular reference to the factors in paragraph (d)(1) of this section, and the specific aspect or aspects of the subject matter of the proceeding as to which petitioner wishes to intervene.
(3) Any person who has filed a petition for leave to intervene or who has been admitted as a party pursuant to this section may amend his petition for leave to intervene. A petition may be amended without prior approval of the presiding officer at any time up to fifteen (15) days prior to the holding of the special prehearing conference pursuant to § 2.751a, or where no special prehearing conference is held, fifteen (15) days prior to the holding of the first prehearing conference. After this time a petition may be amended only with approval of the presiding officer, based on a balancing of the factors specified in paragraph (a)(1) of this section. Such an amended petition for leave to intervene must satisfy the requirements of this paragraph (a) of this section pertaining to specificity.
(b)(1) Not later than fifteen (15) days prior to the holding of the special prehearing conference pursuant to § 2.751a, or if no special prehearing conference is held, fifteen (15) days prior to the holding of the first prehearing conference, the petitioner shall file a supplement to his or her petition to intervene that must include a list of the contentions which petitioner seeks to have litigated in the hearing. A petitioner who fails to file a supplement that satisfies the requirements of paragraph (b)(2) of this section with respect to at least one contention will not be permitted to participate as a party. Additional time for filing the supplement may be granted based upon a balancing of the factors in paragraph (a)(1) of this section.
(2) Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner shall provide the following information with respect to each contention:
(i) A brief explanation of the bases of the contention.
(ii) A concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing, together with references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion.
(iii) Sufficient information (which may include information pursuant to paragraphs (b)(2) (i) and (ii) of this section) to show that a genuine dispute exists with the applicant on a material issue of law or fact. This showing must include references to the specific portions of the application (including the applicant's environmental report and safety report) that the petitioner disputes and the supporting reasons for each dispute, or, if the petitioner believes that the application fails to contain information on a relevant matter as required by law, the identification of each failure and the supporting reasons for the petitioner's belief. On issues arising under the National Environmental Policy Act, the petitioner shall file contentions based on the applicant's environmental report. The petitioner can amend those contentions or file new contentions if there are data or conclusions in the NRC draft or final environmental impact statement, environmental assessment, or any supplements relating thereto, that differ significantly from the data or conclusions in the applicant's document.
(c) Any party to a proceeding may file an answer to a petition for leave to intervene or a supplement thereto within ten (10) days after service of the petition or supplement, with particular attention to the factors set forth in paragraph (d)(1) of this section. The staff may file such an answer within fifteen (15) days after service of the petition or supplement.
(d) The Commission, the presiding officer, or the Atomic Safety and Licensing Board designated to rule on petitions to intervene and/or requests for hearing shall permit intervention, in any hearing on an application for a license to receive and possess high-level radioactive waste at a geologic repository operations area, by the State in which such area is located and by any affected Indian Tribe as defined in part 60 or 63 of this chapter. In all other circumstances, such ruling body or officer shall, in ruling on—
(1) A petition for leave to intervene or a request for a hearing, consider the following factors, among other things:
(i) The nature of the petitioner's right under the Act to be made a party to the proceeding.
(ii) The nature and extent of the petitioner's property, financial, or other interest in the proceeding.
(iii) The possible effect of any order that may be entered in the proceeding on the petitioner's interest.
(2) The admissibility of a contention, refuse to admit a contention if:
(i) The contention and supporting material fail to satisfy the requirements of paragraph (b)(2) of this section; or
(ii) The contention, if proven, would be of no consequence in the proceeding because it would not entitle petitioner to relief.
(e) If the Commission or the presiding officer determines that any of the admitted contentions constitute pure issues of law, those contentions must be decided on the basis of briefs or oral argument according to a schedule determined by the Commission or presiding officer.
(f) An order permitting intervention and/or directing a hearing may be conditioned on such terms as the Commission, presiding officer or the designated atomic safety and licensing board may direct in the interests of:
(1) Restricting irrelevant, duplicative, or repetitive evidence and argument,
(2) Having common interests represented by a spokesman, and
(3) Retaining authority to determine priorities and control the compass of the hearing.
(g) In any case in which, after consideration of the factors set forth in paragraph (d)(1) of this section, the Commission or the presiding officer finds that the petitioner's interest is limited to one or more of the issues involved in the proceeding, any order allowing intervention shall limit his participation accordingly.
(h) A person permitted to intervene becomes a party to the proceeding, subject to any limitations imposed pursuant to paragraph (f) of this section.
(i) Unless otherwise expressly provided in the order allowing intervention, the granting of a petition for leave to intervene does not change or enlarge the issues specified in the notice of hearing.
(j) The provisions of this section do not apply to license applications docketed under subpart J of this part.
(a) Notwithstanding the provisions of § 2.730(f), an order of the presiding officer or the atomic safety and licensing board designated to rule on petitions for leave to intervene and/or requests for hearing may be appealed, in accordance with the provisions of this section, to the Commission within ten (10) days after service of the order. The appeal shall be asserted by the filing of a notice of appeal and accompanying supporting brief. Any other party may file a brief in support of or in opposition to the appeal within ten (10) days after service of the appeal. No other appeals from rulings on petitions and/or requests for hearing shall be allowed.
(b) An order wholly denying a petition for leave to intervene and/or request for a hearing is appealable by the petitioner on the question whether the petition and/or hearing request should have been granted in whole or in part.
(c) An order granting a petition for leave to intervene and/or request for a hearing is appealable by a party other than the petitioner on the question whether the petition and/or the request for a hearing should have been wholly denied.
(a) A person who is not a party may, in the discretion of the presiding officer, be permitted to make a limited appearance by making oral or written statement of his position on the issues at any session of the hearing or any prehearing conference within such limits and on such conditions as may be fixed by the presiding officer, but he may not otherwise participate in the proceeding.
(b) The Secretary will give notice of a hearing to any person who requests it prior to the issuance of the notice of hearing, and will furnish a copy of the notice of hearing to any person who requests it thereafter. When a communication bears more than one signature, the Commission will give the notice to the person first signing unless the communication clearly indicates otherwise.
(c) The presiding officer will afford representatives of an interested State, county, municipality, Federally-recognized Indian Tribe, and/or agencies thereof, a reasonable opportunity to participate and to introduce evidence, interrogate witnesses, and advise the Commission without requiring the representative to take a position with respect to the issue. Such participants may also file proposed findings and exceptions pursuant to §§ 2.754 and 2.762 and petitions for review by the Commission pursuant to § 2.786. The presiding officer may require such representative to indicate with reasonable specificity, in advance of the hearing, the subject matters on which he desires to participate.
(d) If a matter is taken up by the Commission pursuant to § 2.786, a person who is not a party may, in the discretion of the Commission, respectively, be permitted to file a brief “amicus curiae”. A person who is not a party and desires to file a brief must submit a motion for leave to do so
On motion or on its or his own initiative, the Commission or the presiding officer may order any parties in a proceeding for the issuance of a construction permit or an operating license for a production or utilization facility who have substantially the same interest that may be affected by the proceeding and who raise substantially the same questions, to consolidate their presentation of evidence, cross-examination, briefs, proposed findings of fact, and conclusions of law and argument. However, it may not order any consolidation that would prejudice the rights of any party. A consolidation under this section may be for all purposes of the proceeding, all of the issues of the proceeding, or with respect to any one or more issues thereof.
On motion and for good cause shown or on its own initiative, the Commission or the presiding officers of each affected proceeding may consolidate for hearing or for other purposes two or more proceedings, or may hold joint hearings with interested States and/or other federal agencies on matters of concurrent jurisdiction, if it is found that such action will be conducive to the proper dispatch of its business and to the ends of justice and will be conducted in accordance with the other provisions of this subpart.
(a) Unless otherwise ordered by the Commission, the jurisdiction of the presiding officer designated to conduct a hearing over the proceeding, including motions and procedural matters, commences when the proceeding commences. If no presiding officer has been designated, the Chief Administrative Law Judge has such jurisdiction or, if he is unavailable, another administrative law judge has such jurisdiction. A proceeding is deemed to commence when a notice of hearing or a notice of proposed action pursuant to § 2.105 is issued. When a notice of hearing provides that the presiding officer is to be an administrative law judge, the Chief Administrative Law Judge will designate by order the administrative law judge who is to preside. The presiding officer's jurisdiction in each proceeding will terminate upon the expiration of the period within which the Commission may direct that the record be certified to it for final decision, or when the Commission renders a final decision, or when the presiding officer shall have withdrawn himself from the case upon considering himself disqualified, whichever is earliest.
(b) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, may issue an order and take any otherwise proper administrative action with respect to a licensee who is a party to a pending proceeding. Any order related to the subject matter of the pending proceeding may be modified by the presiding officer as appropriate for the purpose of the proceeding.
A presiding officer has the duty to conduct a fair and impartial hearing according to law, to take appropriate action to avoid delay, and to maintain order. He has all powers necessary to those ends, including the powers to:
(a) Administer oaths and affirmations.
(b) Issue subpoenas authorized by law.
(c) Rule on offers of proof, and receive evidence.
(d) Order depositions to be taken.
(e) Regulate the course of the hearing and the conduct of the participants.
(f) Dispose of procedural requests or similar matters.
(g) Examine witnesses.
(h) Hold conferences before or during the hearing for settlement, simplification of the issues, or any other proper purpose.
(i) Certify questions to the Commission for its determination, either in his discretion or on direction of the Commission.
(j) Reopen a proceeding for the reception of further evidence at any time prior to initial decision.
(k) Appoint special assistants from the Atomic Safety and Licensing Board Panel pursuant to § 2.722;
(l) Issue initial decisions; and
(m) Take any other action consistent with the Act, this chapter, and sections 551-558 of title 5 of the United States Code.
(a) On application by any party, the designated presiding officer or, if he is not available, the Chairman of the Atomic Safety and Licensing Board Panel, the Chief Administrative Law Judge, or other designated officer will issue subpoenas requiring the attendance and testimony of witnesses or the production of evidence. The officer to whom application is made may require a showing of general relevance of the testimony or evidence sought, and may withhold the subpoena if such a showing is not made, but he shall not attempt to determine the admissibility of evidence.
(b) Every subpoena will bear the name of the Commission, the name and office of the issuing officer and the title of the hearing, and will command the person to whom it is directed to attend and give testimony or produce specified documents or other things at a designated time and place. The subpoena will also advise of the quashing procedure provided in paragraph (f) of this section.
(c) Unless the service of a subpoena is acknowledged on its face by the witness or is served by an officer or employee of the Commission, it shall be served by a person who is not a party to the hearing and is not less than eighteen (18) years of age. Service of a subpoena shall be made by delivery of a copy of the subpoena to the person named in it and tendering him the fees for one day's attendance and the mileage allowed by law. When the subpoena is issued on behalf of the Commission, fees and mileage need not be tendered, and the subpoena may be served by registered mail.
(d) Witnesses summoned by subpoena shall be paid, by the party at whose instance they appear, the fees and mileage paid to witnesses in the district courts of the United States.
(e) The person serving the subpoena shall make proof of service by filing the subpoena and affidavit or acknowledgment of service with the officer before whom the witness is required to testify or produce evidence or with the Secretary. Failure to make proof of service shall not affect the validity of the service.
(f) On motion made promptly, and in any event at or before the time specified in the subpoena for compliance by the person to whom the subpoena is directed, and on notice to the party at whose instance the subpoena was issued, the presiding officer or, if he is unavailable, the Commission may: (1) Quash or modify the subpoena if it is unreasonable or requires evidence not relevant to any matter in issue, or (2) condition denial of the motion on just and reasonable terms.
(g) On application and for good cause shown, the Commission will seek judicial enforcement of a subpoena issued to a party and which has not been quashed.
(h)(1) The provisions of paragraphs (a) through (g) of this section are not applicable to the attendance and testimony of the Commissioners or NRC personnel, or to the production of records or documents in the custody thereof.
(2)(i) In a proceeding in which the NRC is a party, the NRC staff will make available one or more witnesses designated by the Executive Director for Operations, for oral examination at the hearing or on deposition regarding any matter, not privileged, which is relevant to the issues in the proceeding. The attendance and testimony of the Commissioners and named NRC personnel at a hearing or on deposition may not be required by the presiding officer, by subpoena or otherwise:
(ii) In addition, a party may file with the presiding officer written interrogatories to be answered by NRC personnel with knowledge of the facts designated by the Executive Director for Operations. Upon a finding by the presiding officer that answers to the interrogatories are necessary to a proper decision in the proceeding and that answers to the interrogatories are not reasonably obtainable from any other source, the presiding officer may require that the staff answer the interrogatories.
(iii) No deposition of a particular named NRC employee or answer to interrogatories by NRC personnel pursuant to paragraphs (h)(2) (i) and (ii) of this section shall be required before the matters in controversy in the proceeding have been identified by order of the Commission or the presiding officer, pursuant to § 2.751a, or after the beginning of the prehearing conference held pursuant to § 2.752 except upon leave of the presiding officer for good cause shown.
(iv) The provisions of § 2.740 (c) and (e) shall apply to interrogatories served pursuant to this paragraph.
(3) Records or documents in the custody of the Commissioners and NRC personnel are available for inspection and copying or photographing pursuant to §§ 2.744 and 2.790.
(a) The Commission or the Chairman of the Atomic Safety and Licensing Board Panel may from time to time establish one or more atomic safety and licensing boards, each comprised of three members, one of whom will be qualified in the conduct of administrative proceedings and two of whom shall have such technical or other qualifications as the Commission or the Chairman of the Atomic Safety and Licensing Board Panel deems appropriate to the issues to be decided, to preside in such proceedings for granting, suspending, revoking, or amending licenses or authorizations as the Commission may designate, and to perform such other adjudicatory functions as the Commission deems appropriate. The members of an atomic safety and licensing board shall be designated from the Atomic Safety and Licensing Board Panel established by the Commission.
(b) The Commission or the Chairman of the Atomic Safety and Licensing Board Panel may designate an alternate qualified in the conduct of administrative proceedings, or an alternate having technical or other qualifications, or both, for an atomic safety and licensing board established pursuant to paragraph (a) of this section. If a member of a board becomes unavailable, the Commission or the Chairman of the Atomic Safety and Licensing Board Panel may constitute the alternate qualified in the conduct of administrative proceedings, or the alternate having technical or other qualifications, as appropriate, as a member of the board by notifying the alternate who will, as of the date of such notification, serve as member of the board. In the event that an alternate is unavailable or no alternates have been designated, and a member of a board becomes unavailable, the Commission or the Chairman of the Atomic Safety and Licensing Board Panel may appoint a
(c) An atomic safety and licensing board shall have the duties and may exercise the powers of a presiding officer as granted by § 2.718 and otherwise in this part. At any time when such a board is in existence but is not actually in session, any powers which could be exercised by a presiding officer or by the Chief Administrative Law Judge may be exercised with respect to such a proceeding by the chairman of the board having jurisdiction over it. Two members of an atomic safety and licensing board constitute a quorum, if one of those members is the member qualified in the conduct of administrative proceedings.
(a) In consultation with the Panel Chairman, the presiding officer may, at his discretion, appoint from the Atomic Safety and Licensing Board Panel established by the Commission, personnel to assist the presiding officer in taking evidence and preparing a suitable record for review. Such appointment may occur at any appropriate time during the proceeding but shall, at the time of the appointment, be subject to the notice and disqualification provisions as described in § 2.704. Such special assistants may function as:
(1) Technical interrogators in their individual fields of expertise. Such interrogators shall be required to study the written testimony and sit with the presiding officer to hear the presentation and cross-examination by the parties of all witnesses on the issues of the interrogators’ expertise, taking a leading role in examining such witnesses to ensure that the record is as complete as possible;
(2) Upon consent of all the parties, Special Masters to hear evidentiary presentations by the parties on specific technical matters, and, upon completion of the presentation of evidence, to prepare a report that would become part of the record. Special Masters may rule on evidentiary issues brought before them, in accordance with §§ 2.743 and 2.757. Appeals from such rulings may be taken to the presiding officer in accordance with procedures which shall be established in the presiding officer's order appointing the Special Master. Special Masters’ reports are advisory only; the presiding officer shall retain final authority with respect to the issues heard by the Special Master; or
(3) Alternate Atomic Safety and Licensing Board members to sit with the presiding officer, to participate in the evidentiary sessions on the issue for which the alternate members were designated by examining witnesses, and to advise the presiding officer of their conclusions through an on-the-record report. This report is advisory only; the presiding officer shall retain final authority on the issue for which the alternate member was designated.
(4) Discovery Master to rule on the matters specified in § 2.1018(a)(2) of this part.
(b) The presiding officer may, as a matter of discretion, informally seek the assistance of Members of the Atomic Safety and Licensing Board Panel to brief the presiding officer on the general technical background of subjects involving complex issues which the presiding officer might otherwise have difficulty in quickly grasping. Such informal briefings shall take place prior to the hearing on the subject involved and shall supplement the reading and study undertaken by the presiding officer. They are not subject to the procedures described in § 2.704.
(a)
(b)
(c)
(d)
(e) The Board may dispose of written motions either by written order or by ruling orally during the course of a prehearing conference or hearing. The Board should ensure that parties not present for the oral ruling are notified promptly of the order.
(f)
(g)
(h) Where the motion in question is a motion to compel discovery under § 2.720(h)(2) or § 2.740(f), parties may file answers to the motion pursuant to paragraph (c) of this section. The presiding officer in his or her discretion, may order that the answer be given orally during a telephone conference or other prehearing conference, rather than in writing. If responses are given over the telephone the presiding officer shall issue a written order on the motion which summarizes the views presented by the parties. This does not preclude the presiding officer from issuing a prior oral ruling on the matter which is effective at the time of such ruling, provided that the terms of the ruling are incorporated in the subsequent written order.
The presiding officer or the Commission will designate the order of procedure at a hearing. The proponent of an order will ordinarily open and close.
Unless otherwise ordered by the presiding officer, the applicant or the proponent of an order has the burden of proof.
A party may request the presiding officer to permit a qualified individual who has scientific or technical training or experience to participate on behalf of that party in the examination and cross-examination of expert witnesses. The presiding officer may permit such individual to participate on behalf of the party in the examination and cross-examination of expert witnesses,
(a) A motion to reopen a closed record to consider additional evidence will not be granted unless the following criteria are satisfied:
(1) The motion must be timely, except that an exceptionally grave issue may be considered in the discretion of the presiding officer even if untimely presented.
(2) The motion must address a significant safety or environmental issue.
(3) The motion must demonstrate that a materially different result would be or would have been likely had the newly proffered evidence been considered initially.
(b) The motion must be accompanied by one or more affidavits which set forth the factual and/or technical bases for the movant's claim that the criteria of paragraph (a) of this section have been satisfied. Affidavits must be given by competent individuals with knowledge of the facts alleged, or by experts in the disciplines appropriate to the issues raised. Evidence contained in affidavits must meet the admissibility standards set forth in § 2.743(c). Each of the criteria must be separately addressed, with a specific explanation of why it has been met. Where multiple allegations are involved, the movant must identify with particularity each issue it seeks to litigate and specify the factual and/or technical bases which it believes support the claim that this issue meets the criteria in paragraph (a) of this section.
(c) A motion predicated in whole or in part on the allegations of a confidential informant must identify to the presiding officer the source of the allegations and must request the issuance of an appropriate protective order.
(d) A motion to reopen which relates to a contention not previously in controversy among the parties must also satisfy the requirements for nontimely contentions in § 2.714(a)(1) (i) through (v).
(a)
(b)
(1)
(2)
(3) While interrogatories may seek to elicit factual information reasonably related to a party's position in the proceeding, including data used, assumptions made, and analyses performed by the party, such interrogatories may not be addressed to, or be construed to require:
(A) Reasons for not using alternative data, assumptions, and analyses where the alternative data, assumptions, and analyses were not relied on in developing the party's position; or
(B) Performance of additional research or analytical work beyond that which is needed to support the party's position on any particular matter.
(c)
(1) That the discovery not be had;
(2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place;
(3) That the discovery may be had only by a method of discovery other than that selected by the party seeking discovery;
(4) That certain matters not be inquired into, or that the scope of discovery be limited to certain matters;
(5) That discovery be conducted with no one present except persons designated by the presiding officer;
(6) That, subject to the provisions of §§ 2.744 and 2.790, a trade secret or other confidential research, development, or commercial information not be disclosed or be disclosed only in a designated way;
(7) That studies and evaluations not be prepared.
(d)
(e)
(1) A party is under a duty seasonably to supplement his response with respect to any question directly addressed to (i) the identity and location of persons having knowledge of discoverable matters, and (ii) the identity of each person expected to be called as an expert witness at the hearing, the subject matter on which he is expected to testify, and the substance of his testimony.
(2) A party is under a duty seasonably to amend a prior response if he obtains information upon the basis of which (i) he knows that the response was incorrect when made, or (ii) he knows that the response though correct when made is no longer true and the circumstances are such that a failure to amend the response is in substance a knowing concealment.
(3) A duty to supplement responses may be imposed by order of the presiding officer or agreement of the parties.
(f)
(2) In ruling on a motion made pursuant to this section, the presiding officer may make such a protective order as he is authorized to make on a motion made pursuant to paragraph (c) of this section.
(3) This section does not preclude an independent request for issuance of a subpena directed to a person not a party for production of documents and things. This section does not apply to requests for the testimony or interrogatories of the regulatory staff pursuant to § 2.720(h)(2) or production of NRC documents pursuant to § 2.744 or § 2.790, except for paragraphs (c) and (e) of this section.
(a) Any party desiring to take the testimony of any party or other person by deposition on oral examination or written interrogatories shall, without leave of the Commission or the presiding officer, give reasonable notice in writing to every other party, to the person to be examined and to the presiding officer of the proposed time and place of taking the deposition; the name and address of each person to be examined, if known, or if, the name is not known, a general description sufficient to identify him or the class or group to which he belongs; the matters upon which each person will be examined and the name or descriptive title and address of the officer before whom the deposition is to be taken.
(b) [Reserved]
(c) Within the United States, a deposition may be taken before any officer authorized to administer oaths by the laws of the United States or of the place where the examination is held. Outside of the United States, a deposition may be taken before a secretary of an embassy or legation, a consul general, vice consul or consular agent of the United States, or a person authorized to administer oaths designated by the Commission.
(d) The deponent shall be sworn or shall affirm before any questions are put to him. Examination and cross-examination shall proceed as at a hearing. Each question propounded shall be recorded and the answer taken down in the words of the witness. Objections on questions of evidence shall be noted in short form without the arguments. The officer shall not decide on the competency, materiality, or relevancy of evidence but shall record the evidence subject to objection. Objections on questions of evidence not made before the officer shall not be deemed waived unless the ground of the objection is one which might have been obviated or removed if presented at that time.
(e) When the testimony is fully transcribed, the deposition shall be submitted to the deponent for examination and signature unless he is ill or cannot be found or refuses to sign. The officer shall certify the deposition or, if the deposition is not signed by the deponent, shall certify the reasons for the failure to sign, and shall promptly forward the deposition by registered mail to the Commission.
(f) Where the deposition is to be taken on written interrogatories, the party taking the deposition shall serve a copy of the interrogatories, showing each interrogatory separately and consecutively numbered, on every other party with a notice stating the name and address of the person who is to answer them, and the name, description, title, and address of the officer before whom they are to be taken. Within ten (10) days after service, any other party may serve cross-interrogatories. The interrogatories, cross-interrogatories, and answers shall be recorded and signed, and the deposition certified, returned, and filed as in the case of a deposition on oral examination.
(g) A deposition will not become a part of the record in the hearing unless received in evidence. If only part of a deposition is offered in evidence by a party, any other party may introduce any other parts. A party shall not be deemed to make a person his own witness for any purpose by taking his deposition.
(h) A deponent whose deposition is taken and the officer taking a deposition shall be entitled to the same fees as are paid for like services in the district courts of the United States, to be paid by the party at whose instance the deposition is taken.
(i) The witness may be accompanied, represented, and advised by legal counsel.
(j) The provisions of paragraphs (a) through (i) of this section are not applicable to NRC personnel. Testimony of NRC personnel by oral examination and written interrogatories addressed to NRC personnel are subject to the provisions of § 2.720(h).
(a) Any party may serve upon any other party (other than the staff)
(b) Each interrogatory shall be answered separately and fully in writing under oath or affirmation, unless it is objected to, in which event the reasons for objection shall be stated in lieu of an answer. The answers shall be signed by the person making them, and the objections by the attorney making them. The party upon whom the interrogatories were served shall serve a copy of the answers and objections upon all parties to the proceeding within 14 days after service of the interrogatories, or within such shorter or longer period as the presiding officer may allow. Answers may be used in the same manner as depositions (see § 2.740a(g)).
(a)
(1) Produce and permit the party making the request, or a person acting on his behalf, to inspect and copy any designated documents, or to inspect and copy, test, or sample any tangible things which are within the scope of § 2.740 and which are in the possession, custody, or control of the party upon whom the request is served; or
(2) Permit entry upon designated land or other property in the possession or control of the party upon whom the request is served for the purpose of inspection and measuring, surveying, photographing, testing, or sampling the property or any designated object or operation thereon, within the scope of § 2.740.
(b)
(c)
(d)
(e)
(a) Apart from any admissions made during or as a result of a prehearing conference, at any time after his answer has been filed, a party may file a written request for the admission of the genuineness and authenticity of any relevant document described in or attached to the request, or for the admission of the truth of any specified relevant matter of fact. A copy of the document shall be delivered with the request unless a copy has already been furnished.
(b) Each requested admission shall be deemed made unless, within a time designated by the presiding officer or the Commission, and not less than ten (10) days after service of the request or such further time as may be allowed on motion, the party to whom the request is directed serves on the requesting party either (1) a sworn statement denying specifically the relevant matters of which an admission is requested or setting forth in detail the reasons why he can neither truthfully admit nor deny them, or (2) written objections on the ground that some or all of the matters involved are privileged or irrelevant or that the request is otherwise improper in whole or in part. Answers on matters to which such objections are made may be deferred until the objections are determined. If written objections are made to only a part of a request, the remainder of the request shall be answered within the time designated.
(c) Admissions obtained pursuant to the procedure in this section may be used in evidence to the same extent and subject to the same objections as other admissions.
(a)
(b)(1)
(2) The presiding officer may require a party seeking an opportunity to cross-examine to request permission to do so in accordance with a schedule established by the presiding officer. A request to conduct cross-examination shall be accompanied by a cross-examination plan that contains the following information:
(i) A brief description of the issue or issues on which cross-examination will be conducted;
(ii) The objective to be achieved by cross-examination; and
(iii) The proposed line of questions that may logically lead to achieving the objective of the cross-examination.
(3) Paragraphs (b) (1) and (2) of this section do not apply to proceedings under subpart B of this part for modification, suspension, or revocation of a license or to proceedings for imposition of a civil penalty.
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(2) If a decision is stated to rest in whole or in part on official notice of a fact which the parties have not had a prior opportunity to controvert, a party may controvert the fact by filing an appeal from an initial decision or a petition for reconsideration of a final decision clearly and concisely setting forth the information relied upon to show the contrary.
(a) A request for the production of an NRC record or document not available pursuant to § 2.790 by a party to an initial licensing proceeding may be served on the Executive Director for Operations, without leave of the Commission or the presiding officer. The request shall set forth the records or documents requested, either by individual item or by category, and shall describe each item or category with reasonable particularity and shall state why that record or document is relevant to the proceeding.
(b) If the Executive Director for Operations objects to producing a requested record or document on the ground that (1) it is not relevant or (2) it is exempted from disclosure under § 2.790 and the disclosure is not necessary to a proper decision in the proceeding or the document or the information therein is reasonably obtainable from another source, he shall so advise the requesting party.
(c) If the Executive Director for Operations objects to producing a record or document, the requesting party may apply to the presiding officer, in writing, to compel production of that record or document. The application shall set forth the relevancy of the record or document to the issues in the proceeding. The application shall be processed as a motion in accordance with § 2.730 (a) through (d). The record or document covered by the application shall be produced for the “in camera” inspection of the presiding officer, exclusively, if requested by the presiding officer and only to the extent necessary to determine:
(1) The relevancy of that record or document;
(2) Whether the document is exempt from disclosure under § 2.790;
(3) Whether the disclosure is necessary to a proper decision in the proceeding;
(4) Whether the document or the information therein is reasonably obtainable from another source.
(d) Upon a determination by the presiding officer that the requesting party has demonstrated the relevancy of the record or document and that its production is not exempt from disclosure under § 2.790 or that, if exempt, its disclosure is necessary to a proper decision in the proceeding, and the document or the information therein is not reasonably obtainable from another source, he shall order the Executive Director for Operations, to produce the document.
(e) In the case of requested documents and records (including Safeguards Information referred to in sections 147 and 181 of the Atomic Energy Act, as amended) exempt from disclosure under § 2.790, but whose disclosure is found by the presiding officer to be necessary to a proper decision in the proceeding, any order to the Executive Director for Operations to produce the document or records (or any other order issued ordering production of the document or records) may contain such
(f) A ruling by the presiding officer or the Commission for the production of a record or document will specify the time, place, and manner of production.
(g) No request pursuant to this section shall be made or entertained before the matters in controversy have been identified by the Commission or the presiding officer, or after the beginning of the prehearing conference held pursuant to § 2.752 except upon leave of the presiding officer for good cause shown.
(h) The provisions of § 2.740 (c) and (e) shall apply to production of NRC records and documents pursuant to this section.
(a) Any party to a proceeding may move, with or without supporting affidavits, for a decision by the presiding officer in that party's favor as to all or any part of the matters involved in the proceeding. The moving party shall annex to the motion a separate, short, and concise statement of the material facts as to which the moving party contends that there is no genuine issue to be heard. Motions may be filed at any time. Any other party may serve an answer supporting or opposing the motion, with or without affidavits, within twenty (20) days after service of the motion. The party shall annex to any answer opposing the motion a separate, short, and concise statement of the material facts as to which it is contended there exists a genuine issue to be heard. All material facts set forth in the statement required to be served by the moving party will be deemed to be admitted unless controverted by the statement required to be served by the opposing party. The opposing party may, within ten (10) days after service, respond in writing to new facts and arguments presented in any statement filed in support of the motion. No further supporting statements or responses thereto may be entertained. The presiding officer may dismiss summarily or hold in abeyance motions filed shortly before the hearing commences or during the hearing if the other parties or the presiding officer would be required to divert substantial resources from the hearing in order to respond adequately to the motion and thereby extend the proceeding.
(b) Affidavits shall set forth such facts as would be admissible in evidence and shall show affirmatively that the affiant is competent to testify to the matters stated therein. The presiding officer may permit affidavits to
(c) Should it appear from the affidavits of a party opposing the motion that he cannot, for reasons stated, present by affidavit facts essential to justify his opposition, the presiding officer may refuse the application for summary decision or may order a continuance to permit affidavits to be obtained or make such other order as is appropriate and a determination to that effect shall be made a matter of record.
(d) The presiding officer shall render the decision sought if the filings in the proceeding, depositions, answers to interrogatories, and admissions on file, together with the statements of the parties and the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a decision as a matter of law. However, in any proceeding involving a construction permit for a production or utilization facility, the procedure described in this section may be used only for the determination of specific subordinate issues and may not be used to determine the ultimate issue as to whether the permit shall be issued.
(a) A hearing will be reported under the supervision of the presiding officer, stenographically or by other means, by an official reporter who may be designated by the Commission or may be a regular employee of the Commission. The transcript prepared by the reporter is the sole official transcript of the proceeding. Except as limited pursuant to Sec. 181 of the Act or order of the Commission, the transcript will be available for inspection at the NRC Web site,
(b)
(c)
Except as may be requested pursuant to section 181 of the Act, all hearings will be public unless otherwise ordered by the Commission.
(a) In any proceeding involving an application for a construction permit or an operating license for a production or utilization facility, the Commission or the presiding officer will direct the parties and any petitioners for intervention, or their counsel, to appear at a specified time and place, within ninety (90) days after the notice of hearing is published, or such other time as the Commission or the presiding officer may deem appropriate, for a conference
(1) Permit identification of the key issues in the proceeding;
(2) Take any steps necessary for further identification of the issues;
(3) Consider all intervention petitions to allow the presiding officer to make such preliminary or final determination as to the parties to the proceeding, as may be appropriate; and
(4) Establish a schedule for further actions in the proceeding.
(b) The presiding officer may order any further informal conferences among the parties, including telephone conferences, to the extent that he considers that such a conference would expedite the proceeding.
(c) A prehearing conference held pursuant to this section may be stenographically reported.
(d) The presiding officer shall enter an order which recites the action taken at the conference, the schedule for further actions in the proceeding, any agreements by the parties, and which identifies the key issues in the proceeding, makes a preliminary or final determination as to the parties in the proceeding, and provides for the submission of status reports on discovery. The order shall be served upon all parties to the proceeding. Objections to the order may be filed by a party within five (5) days after service of the order, except that the staff may file objections to such order within ten (10) days after service. Parties may not file replies to the objections unless the Board so directs. The filing of objections shall not stay the decision unless the presiding officer so orders. The board may revise the order in consideration of the objections presented and, as permitted by § 2.718(i), may certify for determination to the Commission such matters raised in the objections as it deems appropriate. The order shall control the subsequent course of the proceeding unless modified for good cause.
(a) The Commission or the presiding officer may, and in the case of a proceeding on an application for a construction permit or an operating license for a facility of a type described in §§ 50.21(b) or 50.22 of this chapter or a testing facility, shall direct the parties or their counsel to appear at a specified time and place for a conference to consider:
(1) Simplification, clarification, and specification of the issues;
(2) The necessity or desirability of amending the pleadings;
(3) The obtaining of stipulations and admissions of fact and of the contents and authenticity of documents to avoid unnecessary proof;
(4) Identification of witnesses and the limitation of the number of expert witnesses, and other steps to expedite the presentation of evidence;
(5) The setting of a hearing schedule; and
(6) Such other matters as may aid in the orderly disposition of the proceeding.
(b) Prehearing conferences may be stenographically reported.
(c) The presiding officer shall enter an order which recites the action taken at the conference, the amendments allowed to the pleadings and agreements by the parties, and which limits the issues or defines the matters in controversy to be determined in the proceeding. Objections to the order may be filed by a party within five (5) days after service of the order, except that the regulatory staff may file objections to such order within ten (10) days after service. Parties may not file replies to the objections unless the board so directs. The filing of objections shall not stay the decision unless the presiding officer so orders. The board may revise the order in the light of the objections presented and, as permitted by § 2.718(i) may certify for determination to the Commission such matters raised in the objections as it deems appropriate. The order shall control the subsequent course of the proceeding unless modified for good cause.
Apart from any stipulations made during or as a result of a prehearing conference, the parties may stipulate in writing at any stage of the proceeding or orally during the hearing, any relevant fact or the contents or authenticity of any document. Such a stipulation may be received in evidence. The parties may also stipulate as to the procedure to be followed in the proceeding. Such stipulations may, on motion of all parties, be recognized by the presiding officer to govern the conduct of the proceeding.
(a) Any party to a proceeding may, or if directed by the presiding officer shall, file proposed findings of fact and conclusions of law, briefs and a proposed form or order of decision within the time provided by the following subparagraphs, except as otherwise ordered by the presiding officer:
(1) The party who has the burden of proof shall, within thirty (30) days after the record is closed, file proposed findings of fact and conclusions of law and briefs, and a proposed form of order or decision.
(2) Other parties may file proposed findings, conclusions of law and briefs within forty (40) days after the record is closed. However, the staff may file such proposed findings, conclusions of law and briefs within fifty (50) days after the record is closed.
(3) A party who has the burden of proof may reply within five (5) days after filing of proposed findings and conclusions of law and briefs by other parties.
(b) Failure to file proposed findings of fact, conclusions of law or briefs when directed to do so may be deemed a default, and an order or initial decision may be entered accordingly.
(c) Proposed findings of fact must be clearly and concisely set forth in numbered paragraphs and must be confined to the material issues of fact presented on the record, with exact citations to the transcript of record and exhibits in support of each proposed finding. Proposed conclusions of law must be set forth in numbered paragraphs as to all material issues of law or discretion presented on the record. An intervenor's proposed findings of fact and conclusions of law must be confined to issues which that party placed in controversy or sought to place in controversy in the proceeding.
When, in the opinion of the presiding officer, time permits and the nature of the proceeding and the public interest warrant, he may allow and fix a time for the presentation of oral argument. He will impose appropriate limits of time on the argument. The transcript of the argument shall be a part of the record.
The Commission encourages the use of informal procedures consistent with the Act, sections 551-558 of title 5 of the United States Code, and the regulations in this chapter, and with the orderly conduct of the proceeding and the necessity for preserving a suitable record for review.
To prevent unnecessary delays or an unnecessarily large record, the presiding officer may:
(a) Limit the number of witnesses whose testimony may be cumulative;
(b) Strike argumentative, repetitious, cumulative, or irrelevant evidence;
(c) Take necessary and proper measures to prevent argumentative, repetitious, or cumulative cross-examination; and
(d) Impose such time limitations on arguments as he determines appropriate, having regard for the volume of the evidence and the importance and complexity of the issues involved.
(a) Except as provided in paragraphs (b), (c), and (d) of this section, any rule or regulation of the Commission, or any provision thereof, issued in its program for the licensing of production and utilization facilities, source material, special nuclear material, or byproduct material is not subject to attack by way of discovery, proof, argument, or other means in any adjudicatory proceeding involving initial or renewal licensing subject to this subpart.
(b) A party to an adjudicatory proceeding involving initial or renewal licensing subject to this subpart may petition that the application of a specified Commission rule or regulation or any provision thereof, of the type described in paragraph (a) of this section, be waived or an exception made for the particular proceeding. The sole ground for petition for waiver or exception shall be that special circumstances with respect to the subject matter of the particular proceeding are such that the application of the rule or regulation (or provision thereof) would not serve the purposes for which the rule or regulation was adopted. The petition shall be accompanied by an affidavit that identifies the specific aspect or aspects of the subject matter of the proceeding as to which the application of the rule or regulation (or provision thereof) would not serve the purposes for which the rule or regulation was adopted, and shall set forth with particularity the special circumstances alleged to justify the waiver or exception requested. Any other party may file a response thereto, by counter affidavit or otherwise.
(c) If, on the basis of the petition, affidavit and any response thereto provided for in paragraph (b) of this section, the presiding officer determines that the petitioning party has not made a prima facie showing that the application of the specific Commission rule or regulation or provision thereof to a particular aspect or aspects of the subject matter of the proceeding would not serve the purposes for which the rule or regulation was adopted and that application of the rule or regulation should be waived or an exception granted, no evidence may be received on that matter and no discovery, cross-examination or argument directed to the matter will be permitted, and the presiding officer may not further consider the matter.
(d) If, on the basis of the petition, affidavit and any response provided for in paragraph (b) of this section, the presiding officer determines that such a prima facie showing has been made, the presiding officer shall, before ruling
(e) Whether or not the procedure in paragraph (b) of this section is available, a party to an initial or renewal licensing proceeding may file a petition for rulemaking pursuant to § 2.802.
The Commission recognizes that the public interest may be served through settlement of particular issues in a proceeding or the entire proceeding. Therefore, to the extent that it is not inconsistent with hearing requirements in section 189 of the Act (42 U.S.C. 2239), the fair and reasonable settlement of contested initial licensing proceedings is encouraged. It is expected that the presiding officer and all of the parties to those proceedings will take appropriate steps to carry out this purpose.
(a) After hearing, the presiding officer will render an initial decision which will constitute the final action of the Commission forty (40) days after its date unless any party petitions for Commission review in accordance with § 2.786 or the Commission takes review sua sponte or the decision is subject to the provisions of § 2.764.
(b) Where the public interest so requires, the Commission may direct that the presiding officer certify the record to it without an initial decision, and may:
(1) Prepare its own decision which will become final unless the Commission grants a petition for reconsideration pursuant to § 2.771; or
(2) Omit an initial decision on a finding that due and timely execution of its functions imperatively and unavoidably so requires.
(c) An initial decision will be in writing and will be based on the whole record and supported by reliable, probative, and substantial evidence. The initial decision will include:
(1) Findings, conclusions and rulings, with the reasons or basis for them, on all material issues of fact, law, or discretion presented on the record;
(2) All facts officially noticed and relied on in making the decision;
(3) The appropriate ruling, order or denial of relief with the effective date;
(4) The time within which a petition for review of the decision may be filed, the time within which answers in support of or in opposition to a petition for review filed by another party may be filed and, in the case of an initial decision which may become final in accordance with paragraph (a) of this section, the date when it may become final.
In any initial decision in a contested proceeding on an application for an operating license for a production or utilization facility, the presiding officer shall make findings of fact and conclusions of law on the matters put into controversy by the parties to the proceeding and on matters which have been determined to be the issues in the proceeding by the Commission or the presiding officer. Matters not put into
(a) The presiding officer may determine a proceeding by an order after the conclusion of a hearing without issuing an initial decision, when:
(1) All parties stipulate that the initial decision may be omitted and waive their rights to file a petition for review, to request oral argument, and to seek judicial review;
(2) No unresolved substantial issue of fact, law, or discretion remains, and the record clearly warrants granting the relief requested; and
(3) The presiding officer finds that dispensing with the issuance of the initial decision is in the public interest.
(b) An order entered pursuant to paragraph (a) of this section shall be subject to review by the Commission on its own motion within thirty (30) days after its date.
(c) An initial decision may be made effective immediately, subject to review by the Commission on its own motion within thirty (30) days after its date, except as otherwise provided in this chapter, when:
(1) All parties stipulate that the initial decision may be made effective immediately and waive their rights to file a petition for review, to request oral argument, and to seek judicial review;
(2) No unresolved substantial issue of fact, law, or discretion remains and the record clearly warrants granting the relief requested; and
(3) The presiding officer finds that it is in the public interest to make the initial decision effective immediately.
(d) The provisions of this section do not apply to an initial decision directing the issuance or amendment of a construction permit or construction authorization, or the issuance of an operating license or provisional operating authorization.
In a proceeding on an application for a construction permit for a utilization facility which is subject to § 51.20(b) of this chapter, and is of the type specified in § 51.21(b) (2) or (3) or § 50.22 of this chapter or is a testing facility, the presiding officer shall, unless the parties agree otherwise or the rights of any party would be prejudiced thereby, commence a hearing on issues covered by § 50.10(e)(2)(ii) and subpart A of part 51 of this chapter as soon as practicable after issuance of the staff of its final environmental impact statement, but no later than thirty (30) days after issuance of such statement, and complete such a hearing and issue an initial decision on such matters. Pehearing procedures regarding issues covered by subpart A of part 51 and § 51.10(e)(2)(ii) of this chapter, including any discovery and special prehearing conferences and prehearing conferences as provided in §§ 2.740, 2.740a, 2.740b, 2.741, 2.742, 2.751a, and 2.752, shall be scheduled accordingly. The provisions of §§ 2.754, 2.755, 2.760, 2.762, 2.763, and 2.764(a) shall apply to any proceeding conducted and any initial decision rendered in accordance with this section. Section 2.764(b) shall not apply to any partial initial decision rendered in accordance with this section. This section shall not preclude separate hearings and decisions on other particular issues.
In its discretion the Commission may allow oral argument upon the request of a party made in a petition for review or brief on review, or upon its own initiative.
(a) Except as provided in paragraphs (c) through (f) of this section, or as otherwise ordered by the Commission in special circumstances, an initial decision directing the issuance or amendment of a construction permit, a construction authorization, an operating license, or a license under 10 CFR part 72 to store spent fuel in an independent spent fuel storage installation (ISFSI) at a reactor site shall be effective immediately upon issuance unless the presiding officer finds that good cause has been shown by a party why the initial decision should not become immediately effective, subject to review thereof and further decision by the Commission upon petition for review filed by any party pursuant to § 2.786 or upon its own motion.
(b) Except as provided in paragraphs (c) through (f) of this section, or as otherwise ordered by the Commission in special circumstances, the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, notwithstanding the filing or granting of a petition for review, shall issue a construction permit, a construction authorization, an operating license, or a license under 10 CFR part 72 to store spent fuel in an independent spent fuel storage installation (ISFSI) at a reactor site, or amendments thereto, authorized by an initial decision, within ten (10) days from the date of issuance of the decision.
(c) An initial decision directing the issuance of an initial license for the construction and operation of an independent spent fuel storage installation (ISFSI) located at a site other than a reactor site or a monitored retrievable storage installation (MRS) under 10 CFR part 72 shall become effective only upon order of the Commission. The Director of Nuclear Material Safety and Safeguards shall not issue an initial license for the construction and operation of an independent spent fuel storage installation (ISFSI) located at a site other than a reactor site or a monitored retrievable storage installation (MRS) under 10 CFR part 72 until expressly authorized to do so by the Commission.
(d) [Reserved]
(e)
(ii) In reaching their decisions the Boards should interpret existing regulations and regulatory policies with due consideration to the implications for those regulations and policies of the Three Mile Island accident. As provided in paragraph (e)(3) of this section, in addition to taking generic rulemaking actions, the Commission will be providing case-by-case guidance on changes in regulatory policies in conducting its reviews in adjudicatory proceedings. The Boards shall, in turn, apply these revised regulations and policies in cases then pending before them to the extent that they are applicable. The Commission expects the Licensing Boards to pay particular attention in their decisions to analyzing the evidence on those safety and environmental issues arising under applicable Commission regulations and policies which the Boards believe present serious, close questions and which the Boards believe may be crucial to whether a license should become effective before full appellate review is completed. Furthermore, the Boards should identify any apects of the case which in their judgment, present issues on which prompt Commission policy guidance is called for. The Boards may request the assistance of the parties in identifying such policy issues but, absent specific Commission directives, such policy issues shall not be the subject of discovery, examination, or cross-examination.
(2)
(f)
(ii) In reaching their decisions the Boards should interpret existing regulations and regulatory policies with due consideration to the implications for those regulations and policies of the Three Mile Island accident. In this regard it should be understood that as a result of analyses still under way the Commission may change its present regulations and regulatory policies in important respects and thus compliance with existing regulations may turn out to no longer warrant approval of a license application. As provided in paragraph (f)(2) of this section, in addition to taking generic rulemaking actions, the Commission will be providing case-by-case guidance on changes in regulatory policies in conducting its reviews in adjudicatory proceedings. The Boards shall, in turn, apply these revised regulations and policies in cases then pending before them to the extent that they are applicable. The Commission expects the Licensing Boards to pay particular attention in their decisions to analyzing the evidence on those safety and environmental issues arising under applicable Commission regulations and policies which the Boards believe present serious, close questions and which the Boards believe may be crucial to whether a license should become effective before full appellate review is completed. Furthermore, the Boards should identify any aspects of the case which in their judgment, present issues on which prompt Commission policy guidance is called for. The Boards may request the assistance of the parties in identifying such policy issues but, absent specific Commission directive, such policy issues shall not be the subject of discovery, examination, or cross-examination.
(2)
(ii) For operating license decisions other than those authorizing only fuel loading and low power testing consistent with the target schedule set forth below, the parties may file brief
(iii) The Commission intends to issue a stay decision within 30 days of receipt of the Licensing Board's decision. The Licensing Board's initial decision will be considered stayed pending the Commission's decision insofar as it may authorize operations other than fuel loading and low power (up to 5 percent of rated power) testing.
(iv) In announcing a stay decision, the Commission may allow the proceeding to run its ordinary course or give instructions as to the future handling of the proceeding. Furthermore, the Commission may in a particular case determine that compliance with existing regulations and policies may no longer be sufficient to warrant approval of a license application and may alter those regulations and policies.
(g) The Commission's effectiveness determination is entirely without prejudice to proceedings under § 2.786 or § 2.788.
An initial decision directing the issuance of a license under part 61 of this chapter (relating to land disposal of radioactive waste) or any amendment to such a license authorizing actions which may significantly affect the health and safety of the public, will become effective only upon order of the Commission. The Director of Nuclear Material Safety and Safeguards may not issue a license under part 61 of this chapter, or any amendment to such a license which may significantly affect the health and safety of the public, until expressly authorized to do so by the Commission.
(a) The Commission will ordinarily consider the whole record on review, but may limit the issues to be reviewed to those identified in an order taking review.
(b) The Commission may adopt, modify, or set aside the findings, conclusions and order in the initial decision, and will state the basis of its action. The final decision will be in writing and will include:
(1) A statement of findings and conclusions, with the basis for them on all material issues of fact, law or discretion presented;
(2) All facts officially noticed;
(3) The ruling on each material issue; and
(4) The appropriate ruling, order, or denial of relief, with the effective date.
(a) A petition for reconsideration of a final decision may be filed by a party within ten (10) days after the date of the decision.
(b) The petition for reconsideration shall state specifically the respects in which the final decision is claimed to be erroneous, the grounds of the petition, and the relief sought. Within ten (10) days after a petition for reconsideration has been filed, any other party may file an answer in opposition to or in support of the petition. However, the staff may file such an answer within twelve (12) days after a petition for reconsideration has been filed.
(c) Neither the filing nor the granting of the petition shall stay the decision unless the Commission orders otherwise.
When briefs, motions or other papers listed herein are submitted to the Commission itself, as opposed to officers who have been delegated authority to act for the Commission, the Secretary or the Assistant Secretary are authorized to:
(a) Prescribe schedules for the filing of briefs, motions, or other pleadings, where such schedules may differ from those elsewhere prescribed in these rules or where these rules do not prescribe a schedule;
(b) Rule on motions for extensions of time;
(c) Reject motions, briefs, pleadings, and other documents filed with the Commission later than the time prescribed by the Secretary or the Assistant Secretary or established by an order, rule, or regulation of the Commission unless good cause is shown for the late filing;
(d) Prescribe all procedural arrangements relating to any oral argument to be held before the Commission;
(e) Extend the time for the Commission to rule on a petition for review under 10 CFR 2.786(b);
(f) Extend the time for the Commission to grant review on its own motion under 10 CFR 2.786(a);
(g) Extend time for Commission review on its own motion of a Director's denial under 10 CFR 2.206(c);
(h) Direct pleadings improperly filed before the Commission to the appropriate adjudicatory board for action;
(i) Deny a request for hearings, where the request fails to comply with the Commission's pleading requirements set forth in this part, and fails to set forth an arguable basis for further proceedings;
(j) Refer to the Atomic Safety and Licensing Board Panel or an Administrative Law Judge, as appropriate, requests for hearings not falling under § 2.104 of this part, where the requester is entitled to further proceedings; and
(k) Take action on minor procedural matters.
In any proceeding under this subpart—
(a) Interested persons outside the agency may not make or knowingly cause to be made to any Commission adjudicatory employee, any ex parte communication relevant to the merits of the proceeding.
(b) Commission adjudicatory employees may not request or entertain from any interested person outside the agency or make or knowingly cause to be made to any interested person outside the agency, and ex parte communication relevant to the merits of the proceeding.
(c) Any Commission adjudicatory employee who receives, makes, or knowingly causes to be made a communication prohibited by this section shall ensure that it and any responses to the communication promptly are served on the parties and placed in the public record of the proceeding. In the case of oral communications, a written summary must be served and placed in the public record of the proceeding.
(d) Upon receipt of a communication knowingly made or knowingly caused to be made by a party in violation of this section, the Commission or other adjudicatory employee presiding in a proceeding may, to the extent consistent with the interests of justice and the policy of the underlying statutes, require the party to show cause why its claim or interest in the proceeding should not be dismissed, denied, disregarded, or otherwise adversely affected on account of the violation.
(e) (1) The prohibitions of this section apply—
(i) When a notice of hearing or other comparable order is issued in accordance with §§ 2.104(a), 2.105(e)(2), 2.202(c), 2.204, 2.205(e), or 2.703; or
(ii) Whenever the interested person or Commission adjudicatory employee responsible for the communication has knowledge that a notice of hearing or other comparable order will be issued in accordance with §§ 2.104(a), 2.105(e)(2), 2.202(c), 2.204, 2.205(e), or 2.703.
(2) The prohibitions of this section cease to apply to ex parte communications relevant to the merits of a full or partial initial decision when, in accordance with § 2.786, the time has expired for Commission review of the decision.
(f) The prohibitions in this section do not apply to—
(1) Requests for and the provision of status reports;
(2) Communications specifically permitted by statute or regulation;
(3) Communications made to or by Commission adjudicatory employees in the Office of the General Counsel regarding matters pending before a court or another agency; and
(4) Communications regarding generic issues involving public health and safety or other statutory responsibilities of the agency (e.g., rulemakings, congressional hearings on legislation, budgetary planning) not associated with the resolution of any proceeding under this subpart pending before the NRC.
(a) In any proceeding under this subpart, any NRC officer or employee engaged in the performance of any investigative or litigating function in that proceeding or in a factually related proceeding may not participate in or advise a Commission adjudicatory employee about the initial or final decision on any disputed issue in that proceeding, except—
(1) As witness or counsel in the proceeding;
(2) Through a written communication served on all parties and made on the record of the proceeding; or
(3) Through an oral communication made both with reasonable prior notice to all parties and with reasonable opportunity for all parties to respond.
(b) The prohibition in paragraph (a) of this section does not apply to—
(1) Communications to or from any Commission adjudicatory employee regarding—
(i) The status of a proceeding;
(ii) Matters with regard to which the communications specifically are permitted by statute or regulation;
(iii) Agency participation in matters pending before a court or another agency; or
(iv) Generic issues involving public health and safety or other statutory responsibilities of the agency (e.g., rulemakings, congressional hearings on legislation, budgetary planning) not associated with the resolution of any proceeding under this subpart pending before the NRC.
(2) Communications to or from Commissioners, members of their personal staffs, Commission adjudicatory employees in the Office of the General Counsel, and the Secretary and employees of the Office of the Secretary, regarding—
(i) Initiation or direction of an investigation or initiation of an enforcement proceeding;
(ii) Supervision of agency staff to ensure compliance with the general policies and procedures of the agency;
(iii) Staff priorities and schedules or the allocation of agency resources; or
(iv) General regulatory, scientific, or engineering principles that are useful for an understanding of the issues in a proceeding and are not contested in the proceeding.
(3) None of the communications permitted by paragraph (b)(2) (i) through (iii) of this section is to be associated by the Commission adjudicatory employee or the NRC officer or employee performing investigative or litigating functions with the resolution of any proceeding under this subpart pending before the NRC.
(c) Any Commission adjudicatory employee who receives a communication prohibited under paragraph (a) of this section shall ensure that it and any responses to the communication are placed in the public record of the proceeding and served on the parties. In the case of oral communications, a written summary must be served and placed in the public record of the proceeding.
(d)(1) The prohibitions in this section apply—
(i) When a notice of hearing or other comparable order is issued in accordance with §§ 2.104(a), 2.105(e)(2), 2.202(c), 2.204, 2.205(e), or 2.703; or
(ii) Whenever an NRC officer or employee who is or has reasonable cause
(2) The prohibitions of this section will cease to apply to the disputed issues pertinent to a full or partial initial decision when, in accordance with § 2.786, the time has expired for Commission review of the decision.
(e) Communications to, from, and between Commission adjudicatory employees not prohibited by this section may not serve as a conduit for a communication that otherwise would be prohibited by this section or for an ex parte communication that otherwise would be prohibited by § 2.780.
(f) If an initial or final decision is stated to rest in whole or in part on fact or opinion obtained as a result of a communication authorized by this section, the substance of the communication must be specified in the record of the proceeding and every party must be afforded an opportunity to controvert the fact or opinion. If the parties have not had an opportunity to controvert the fact or opinion prior to the filing of the decision, a party may controvert the fact or opinion by filing a petition for review of an initial decision, or a petition for reconsideration of a final decision that clearly and concisely sets forth the information or argument relied on to show the contrary. If appropriate, a party may be afforded the opportunity for cross-examination or to present rebuttal evidence.
(a) Within forty (40) days after the date of a decision or action by a presiding officer, or within thirty (30) days after a petition for review of the decision or action has been filed under paragraph (b) of this section, whichever is greater, the Commission may review the decision or action on its own motion, unless the Commission, in its discretion, extends the time for its review.
(b)(1) Within fifteen (15) days after service of a full or partial initial decision by a presiding officer, and within fifteen (15) days after service of any other decision or action by a presiding officer with respect to which a petition for review is authorized by this part, a party may file a petition for review with the Commission on the grounds specified in paragraph (b)(4) of this section. The filing of a petition for review is mandatory for a party to exhaust its administrative remedies before seeking judicial review.
(2) A petition for review under this paragraph must be no longer than ten (10) pages, and must contain the following:
(i) A concise summary of the decision or action of which review is sought;
(ii) A statement (including record citation) where the matters of fact or law raised in the petition for review were previously raised before the presiding officer and, if they were not why they could not have been raised;
(iii) A concise statement why in the petitioner's view the decision or action is erroneous; and
(iv) A concise statement why Commission review should be exercised.
(3) Any other party to the proceeding may, within ten (10) days after service of a petition for review, file an answer supporting or opposing Commission review. This answer must be no longer than ten (10) pages and should concisely address the matters in paragraph (b)(2) of this section to the extent appropriate. The petitioning party shall have no right to reply, except as permitted by the Commission.
(4) The petition for review may be granted in the discretion of the Commission, giving due weight to the existence of a substantial question with respect to the following considerations:
(i) A finding of material fact is clearly erroneous or in conflict with a finding as to the same fact in a different proceeding;
(ii) A necessary legal conclusion is without governing precedent or is a departure from or contrary to established law;
(iii) A substantial and important question of law, policy or discretion has been raised;
(iv) The conduct of the proceeding involved a prejudicial procedural error; or
(v) Any other consideration which the Commission may deem to be in the public interest.
(5) A petition for review will not be granted to the extent that it relies on matters that could have been but were not raised before the presiding officer. A matter raised sua sponte by a presiding officer has been raised before the presiding officer for the purpose of this section.
(6) A petition for review will not be granted as to issues raised before the presiding officer on a pending motion for reconsideration.
(c) If within thirty (30) days after the filing of a petition for review the Commission does not grant the petition, in whole or in part, the petition shall be deemed denied, unless the Commission in its discretion extends the time for its consideration of the petition and any answers thereto.
(d) If a petition for review is granted, the Commission will issue an order specifying the issues to be reviewed and designating the parties to the review proceeding and direct that appropriate briefs be filed, oral argument be held, or both.
(e) Petitions for reconsideration of Commission decisions granting or denying review in whole or in part will not be entertained. A petition for reconsideration of a Commission decision after review may be filed within ten (10) days, but is not necessary for exhaustion of administrative remedies. However, if a petition for reconsideration is filed, the Commission decision is not final until the petition is decided.
(f) Neither the filing nor the granting of a petition for review will stay the effect of the decision or action of the presiding officer, unless otherwise ordered by the Commission.
(g) Certified questions and referred rulings. A question certified to the Commission under § 2.718(i) or a ruling referred under § 2.730(f) must meet one of the alternative standards in this subsection to merit Commission review. A certified question or referred ruling will be reviewed if it either—
(1) Threatens the party adversely affected by it with immediate and serious irreparable impact which, as a practical matter, could not be alleviated through a petition for review of the presiding officer's final decision; or
(2) Affects the basic structure of the proceeding in a pervasive or unusual manner.
(a) Within ten (10) days after service of a decision or action of a presiding officer any party to the proceeding may file an application for a stay of the effectiveness of the decision or action pending filing of and a decision on a petition for review. This application may be filed with the Commission or the presiding officer, but not both at the same time.
(b) An application for a stay must be no longer than ten (10) pages, exclusive of affidavits, and must contain the following:
(1) A concise summary of the decision or action which is requested to be stayed;
(2) A concise statement of the grounds for stay, with reference to the factors specified in paragraph (e) of this section; and
(3) To the extent that an application for a stay relies on facts subject to dispute, appropriate references to the record or affidavits by knowledgeable persons.
(c) Service of an application for a stay on the other parties shall be by the same method, e.g., telecopier message, mail, as the method for filing the application with the Commission or the presiding officer.
(d) Within ten (10) days after service of an application for a stay under this section, any party may file an answer supporting or opposing the granting of a stay. This answer must be no longer than ten (10) pages, exclusive of affidavits, and should concisely address the matters in paragraph (b) of this section to the extent appropriate. No further replies to answers will be entertained. Filing of and service of an answer on the other parties must be by the same method, e.g., telecopier message, mail,
(e) In determining whether to grant or deny an application for a stay, the Commission or presiding officer will consider:
(1) Whether the moving party has made a strong showing that it is likely to prevail on the merits;
(2) Whether the party will be irreparably injured unless a stay is granted;
(3) Whether the granting of a stay would harm other parties; and
(4) Where the public interest lies.
(f) In extraordinary cases, where prompt application is made under this section, the Commission or presiding officer may grant a temporary stay to preserve the status quo without waiting for filing of any answer. The application may be made orally provided the application is promptly confirmed by telecopier message. Any party applying under this paragraph shall make all reasonable efforts to inform the other parties of the application, orally if made orally.
(a) Subject to the provisions of paragraphs (b), (d), and (e) of this section, final NRC records and documents, including but not limited to correspondence to and from the NRC regarding the issuance, denial, amendment, transfer, renewal, modification, suspension, revocation, or violation of a license, permit, or order, or regarding a rulemaking proceeding subject to this part shall not, in the absence of a compelling reason for nondisclosure after a balancing of the interests of the person or agency urging nondisclosure and the public interest in disclosure, be exempt from disclosure and will be made available for inspection and copying at the NRC Web site,
(1)(i) Specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy and (ii) are in fact properly classified pursuant to such Executive order;
(2) Related solely to the internal personnel rules and practices of the Commission;
(3) Specifically exempted from disclosure by statute (other than 5 U.S.C.) 552(b), provided that such statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (ii) establishes particular criteria for withholding or refers to particular types or matters to be withheld.
(4) Trade secrets and commercial or financial information obtained from a person and privileged or confidential;
(5) Interagency or intraagency memorandums or letters which would not be available by law to a party other than an agency in litigation with the Commission;
(6) Personnel and medical files and similar files, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
(7) Records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information.
(i) Could reasonably be expected to interfere with enforcement proceedings;
(ii) Would deprive a person of a right to a fair trial or an impartial adjudication;
(iii) Could reasonably be expected to constitute an unwarranted invasion of personal privacy;
(iv) Could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority, or any private institution which furnished information on a confidential basis, and, in the case of a record or information compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, information furnished by a confidential source;
(v) Would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law; or
(vi) Could reasonably be expected to endanger the life or physical safety of any individual;
(8) Contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or
(9) Geological and geophysical information and data, including maps, concerning wells.
(b)(1) A person who proposes that a document or a part be withheld in whole or part from public disclosure on the ground that it contains trade secrets or privileged or confidential commercial or financial information shall submit an application for withholding accompanied by an affidavit which:
(i) Identifies the document or part sought to be withheld and the position of the person making the affidavit, and
(ii) Contains a full statement of the reasons on the basis of which it is claimed that the information should be withheld from public disclosure. Such statement shall address with specificity the considerations listed in paragraph (b)(4) of this section. In the case of an affidavit submitted by a company, the affidavit shall be executed by an officer or upper-level management official who has been specifically delegated the function of reviewing the information sought to be withheld and authorized to apply for its withholding on behalf of the company. The affidavit shall be executed by the owner of the information, even though the information sought to be withheld is submitted to the Commission by another person. The application and affidavit shall be submitted at the time of filing the information sought to be withheld. The information sought to be withheld shall be incorporated, as far as possible, into a separate paper. The affiant may designate with appropriate markings information submitted in the affidavit as a trade secret or confidential or privileged commercial or financial information within the meaning of § 9.17(a)(4) of this chapter and such information shall be subject to disclosure only in accordance with the provisions of § 9.19 of this chapter.
(2) A person who submits commercial or financial information believed to be privileged or confidential or a trade secret shall be on notice that it is the policy of the Commission to achieve an effective balance between legitimate concerns for protection of competitive positions and the right of the public to be fully apprised as to the basis for and effects of licensing or rule making actions, and that it is within the discretion of the Commission to withhold such information from public disclosure.
(3) The Commission shall determine whether information sought to be withheld from public disclosure pursuant to this paragraph: (i) is a trade secret or confidential or privileged commercial or financial information; and (ii) if so, should be withheld from public disclosure.
(4) In making the determination required by paragraph (b)(3)(i) of this section, the Commission will consider:
(i) Whether the information has been held in confidence by its owner;
(ii) Whether the information is of a type customarily held in confidence by its owner and whether there is a rational basis therefor;
(iii) Whether the information was transmitted to and received by the Commission in confidence;
(iv) Whether the information is available in public sources;
(v) Whether public disclosure of the information sought to be withheld is likely to cause substantial harm to the competitive position of the owner of the information, taking into account the value of the information to the owner; the amount of effort or money, if any, expended by the owner in developing the information; and the ease or difficulty with which the information could be properly acquired or duplicated by others.
(5) If the Commission determines, pursuant to paragraph (b)(4) of this section, that the record or document contains trade secrets or privileged or confidential commercial or financial information, the Commission will then determine (i) whether the right of the public to be fully apprised as to the bases for and effects of the proposed action outweighs the demonstrated concern for protection of a competitive position and (ii) whether the information
(6) Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the document. The Commission may require information claimed to be a trade secret or privileged or confidential commercial or financial information to be subject to inspection: (i) Under a protective agreement, by contractor personnel or government officials other than NRC officials; (ii) by the presiding officer in a proceeding; and (iii) under protective order, by parties to a proceeding, pending a decision of the Commission on the matter of whether the information should be made publicly available or when a decision has been made that the information should be withheld from public disclosure. In camera sessions of hearings may be held when the information sought to be withheld is produced or offered in evidence. If the Commission subsequently determines that the information should be disclosed, the information and the transcript of such in camera session will be made publicly available.
(c) If a request for withholding pursuant to paragraph (b) of this section is denied, the Commission will notify an applicant for withholding of the denial with a statement of reasons. The notice of denial will specify a time, not less than thirty (30) days after the date of the notice, when the document will be available at the NRC Web site,
(d) The following information shall be deemed to be commercial or financial information within the meaning of § 9.17(a)(4) of this chapter and shall be subject to disclosure only in accordance with the provisions of § 9.19 of this chapter.
(1) Correspondence and reports to or from the NRC which contain information or records concerning a licensee's or applicant's physical protection, classified matter protection, or material control and accounting program for special nuclear material not otherwise designated as Safeguards Information or classified as National Security Information or Restricted Data.
(2) Information submitted in confidence to the Commission by a foreign source.
(e) The presiding officer, if any, or the Commission may, with reference to the NRC records and documents made available pursuant to this section, issue orders consistent with the provisions of this section and § 2.740(c).
This subpart governs the issuance, amendment and repeal of regulations in which participation by interested persons is prescribed under section 553 of title 5 of the U.S. Code.
Rulemaking may be initiated by the Commission at its own instance, on the recommendation of another agency of the United States, or on the petition of any other interested person.
(a) Any interested person may petition the Commission to issue, amend or rescind any regulation. The petition
(b) A prospective petitioner may consult with the NRC before filing a petition for rulemaking by writing to the Chief, Rules and Directives Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. A prospective petitioner also may telephone the Rules and Directives Branch on (301) 415-7163 or toll free on (800) 368-5642.
(1) In any consultation prior to the filing of a petition for rulemaking, the assistance that may be provided by the NRC staff is limited to—
(i) Describing the procedure and process for filing and responding to a petition for rulemaking;
(ii) Clarifying an existing NRC regulation and the basis for the regulation; and
(iii) Assisting the prospective petitioner to clarify a potential petition so that the Commission is able to understand the nature of the issues of concern to the petitioner.
(2) In any consultation prior to the filing of a petition for rulemaking, in providing the assistance permitted in paragraph (b)(1) of this section, the NRC staff will not draft or develop text or alternative approaches to address matters in the prospective petition for rulemaking.
(c) Each petition filed under this section shall:
(1) Set forth a general solution to the problem or the substance or text of any proposed regulation or amendment, or specify the regulation which is to be revoked or amended;
(2) State clearly and concisely the petitioner's grounds for and interest in the action requested;
(3) Include a statement in support of the petition which shall set forth the specific issues involved, the petitioner's views or arguments with respect to those issues, relevant technical, scientific or other data involved which is reasonably available to the petitioner, and such other pertinent information as the petitioner deems necessary to support the action sought. In support of its petition, petitioner should note any specific cases of which petitioner is aware where the current rule is unduly burdensome, deficient, or needs to be strengthened.
(d) The petitioner may request the Commission to suspend all or any part of any licensing proceeding to which the petitioner is a party pending disposition of the petition for rulemaking.
(e) If it is determined that the petition includes the information required by paragraph (c) of this section and is complete, the Director, Division of Administrative Services, Office of Administration, or designee, will assign a docket number to the petition, will cause the petition to be formally docketed, and will make a copy of the docketed petition available at the NRC Web site,
(f) If it is determined by the Executive Director for Operations that the petition does not include the information required by paragraph (c) of this section and is incomplete, the petitioner will be notified of that determination and the respects in which the petition is deficient and will be accorded an opportunity to submit additional data. Ordinarily this determination will be made within 30 days from the date of receipt of the petition by the Office of the Secretary of the Commission. If the petitioner does not submit additional data to correct the deficiency within 90 days from the date of notification to the petitioner that the petition is incomplete, the petition may be returned to the petitioner without prejudice to the right of the petitioner to file a new petition.
(g) The Director, Division of Administrative Services, Office of Administration, will prepare on a semiannual basis a summary of petitions for rulemaking before the Commission, including the status of each petition. A copy of the report will be available for public inspection and copying at the NRC
No hearing will be held on the petition unless the Commission deems it advisable. If the Commission determines that sufficient reason exists, it will publish a notice of proposed rulemaking. In any other case, it will deny the petition and will notify the petitioner with a simple statement of the grounds of denial.
(a) Except as provided by paragraph (d) of this section, when the Commission proposes to adopt, amend, or repeal a regulation, it will cause to be published in the
(b) The notice will include:
(1) Either the terms or substance of the proposed rule, or a specification of the subjects and issues involved;
(2) The manner and time within which interested members of the public may comment, and a statement that copies of comments may be examined will be made available at the NRC Web site,
(3) The authority under which the regulation is proposed;
(4) The time, place, and nature of the public hearing, if any;
(5) If a hearing is to be held, designation of the presiding officer and any special directions for the conduct of the hearing; and
(6) Such explanatory statement as the Commission may consider appropriate.
(c) The publication or service of notice will be made not less than fifteen (15) days prior to the time fixed for hearing, if any, unless the Commission for good cause stated in the notice provides otherwise.
(d) The notice and comment provisions contained in paragraphs (a), (b), and (c) of this section will not be required to be applied—
(1) To interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or
(2) When the Commission for good cause finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest, and are not required by statute. This finding, and the reasons therefor, will be incorporated into any rule issued without notice and comment for good cause.
(e) The Commission shall provide for a 30-day post-promulgation comment period for—
(1) Any rule adopted without notice and comment under the good cause exception on paragraph (d)(2) of this section where the basis is that notice and comment is “impracticable” or “contrary to the public interest.”
(2) Any interpretative rule, or general statement of policy adopted without notice and comment under paragraph (d)(1) of this section, except for those cases for which the Commission finds that such procedures would serve no public interest, or would be so burdensome as to outweigh any foreseeable gain.
(f) For any post-promulgation comments received under paragraph (e) of this section, the Commission shall publish a statement in the
(a) In all rulemaking proceedings conducted under the provisions of § 2.804(a), the Commission will afford interested persons an opportunity to participate through the submission of statements, information, opinions, and arguments in the manner stated in the notice. The Commission may grant additional reasonable opportunity for the submission of comments.
(b) The Commission may hold informal hearings at which interested persons may be heard, adopting procedures which in its judgment will best serve the purpose of the hearing.
The Commission will incorporate in the notice of adoption of a regulation a concise general statement of its basis and purpose, and will cause the notice and regulation to be published in the
The notice of adoption of a regulation will specify the effective date. Publication or service of the notice and regulation, other than one granting or recognizing exemptions or relieving from restrictions, will be made not less than thirty (30) days prior to the effective date unless the Commission directs otherwise on good cause found and published in the notice of rule making.
When briefs, motions or other papers listed herein are submitted to the Commission itself, as opposed to officers who have been delegated authority to act for the Commission, the Secretary or the Assistant Secretary are authorized to:
(a) Prescribe schedules for the filing of statements, information, briefs, motions, responses or other pleadings, where such schedules may differ from those elsewhere prescribed in these rules or where these rules do not prescribe a schedule;
(b) Rule on motions for extensions of time;
(c) Reject motions, briefs, pleadings, and other documents filed with the Commission later than the time prescribed by the Secretary or the Assistant Secretary or established by an order, rule, or regulation of the Commission unless good cause is shown for the late filing; and
(d) Prescribe all procedural arrangements relating to any oral argument to be held before the Commission.
(a) In its advisory capacity to the Commission, the ACRS may recommend that the Commission initiate rulemaking in a particular area. The Commission will respond to such rulemaking recommendation in writing within 90 days, noting its intent to implement, study, or defer action on the recommendation. In the event the Commission decides not to accept or decides to defer action on the recommendation, it will give its reasons for doing so. Both the ACRS recommendation and the Commission's response will be made available at the NRC Web site,
(b) When a rule involving nuclear safety matters within the purview of the ACRS is under development by the NRC Staff, the Staff will ensure that the ACRS is given an opportunity to provide advice at appropriate stages and to identify issues to be considered during rulemaking hearings.
The NRC shall use the size standards contained in this section to determine whether a licensee qualifies as a small entity in its regulatory programs.
(a) A small business is a for-profit concern and is a—
(1) Concern that provides a service or a concern not engaged in manufacturing with average gross receipts of $5 million or less over its last 3 completed fiscal years; or
(2) Manufacturing concern with an average number of 500 or fewer employees based upon employment during each pay period for the preceding 12 calendar months.
(b) A small organization is a not-for-profit organization which is independently owned and operated and has annual gross receipts of $5 million or less.
(c) A small governmental jurisdiction is a government of a city, county, town, township, village, school district, or special district with a population of less than 50,000.
(d) A small educational institution is one that is—
(1) Supported by a qualifying small governmental jurisdiction; or
(2) Not state or publicly supported and has 500 or fewer employees.
(e) For the purposes of this section, the NRC shall use the Small Business Administration definition of receipts (13 CFR 121.402(b)(2)). A licensee who is a subsidiary of a large entity does not qualify as a small entity for purposes of this section.
(f) Whenever appropriate in the interest of administering statutes and regulations within its jurisdiction, it is the practice of the NRC to answer inquiries from small entities concerning information on and advice about compliance with the statutes and regulations that affect them. To help small entities obtain information quickly, the NRC has established a toll-free telephone number at 1-800-368-5642.
This subpart is issued pursuant to section 181 of the Atomic Energy Act of 1954, as amended, and section 201 of the Energy Reorganization Act of 1974, as amended, to provide such procedures in proceedings subject to this part as will effectively safeguard and prevent disclosure of Restricted Data and National Security Information to unauthorized persons, with minimum impairment of procedural rights.
This subpart applies to all proceedings subject to subpart G.
As used in this subpart:
(a)
(b)
(c) The phrase
(d)
(e)
Nothing in this subpart shall relieve any person from safeguarding Restricted Data or National Security Information in accordance with the applicable provisions of laws of the United States and rules, regulations or orders of any Government Agency.
On request of any party to a proceeding or of the presiding officer, the Commission will designate a representative to advise and assist the presiding officer and the parties with respect to security classification of information and the safeguards to be observed.
(a) Access to restricted data and national security information introduced into proceedings. Except as provided in paragraph (h) of this section, restricted data or national security information introduced into a proceeding subject to this part will be made available to any interested party having the required security clearance; to counsel for an interested party provided the counsel has the required security clearance; and to such additional persons having the required security clearance as the Commission or the presiding officer determined are needed by such party for adequate preparation or presentation of his case. Where the interest of such party will not be prejudiced, the Commission or presiding officer may postpone action upon an application for access under this paragraph until after a notice of hearing, answers, and replies have been filed.
(b) Access to Restricted Data or National Security Information not introduced into proceedings.
(1) On application showing that access to Restricted Data or National Security Information may be required for the preparation of a party's case, and except as provided in paragraph (h) of this section, the Commission or the presiding officer will issue an order granting access to such Restricted Data or National Security Information to the party upon his obtaining the required security clearance, to counsel for the party upon their obtaining the required security clearance, and to such other individuals as may be needed by the party for the preparation and presentation of his case upon their obtaining the required clearance.
(2) Where the interest of the party applying for access will not be prejudiced, the Commission or the presiding officer may postpone action on an application pursuant to this paragraph until after a notice of hearing, answers and replies have been filed.
(c) The Commission will consider requests for appropriate security clearances in reasonable numbers pursuant to this section. A reasonable charge will be made by the Commission for costs of security clearance pursuant to this section.
(d) The presiding officer may certify to the Commission for its consideration and determination any questions relating to access to Restricted Data or National Security Information arising under this section. Any party affected by a determination or order of the presiding officer under this section may appeal forthwith to the Commission from the determination or order. The filing by the staff of an appeal from an order of a presiding officer granting access to Restricted Data or National Security Information shall stay the order pending determination of the appeal by the Commission.
(e) Application granting access to restricted data or national security information.
(1) An application under this section for orders granting access to restricted data or national security information not received from another Government agency will normally be acted upon by the presiding officer, or if a proceeding is not before a presiding officer, by the Commission.
(2) An application under this section for orders granting access to restricted data or national security information where the information has been received by the Commission from another Government agency will be acted upon by the Commission.
(f) To the extent practicable, an application for an order granting access under this section shall describe the subjects of Restricted Data or National Security Information to which access is desired and the level of classification (confidential, secret or other) of the information; the reasons why access to the information is requested; the names of individuals for whom clearances are requested; and the reasons why security clearances are being requested for those individuals.
(g) On the conclusion of a proceeding, the Commission will terminate all orders issued in the proceeding for access to Restricted Data or National Security Information and all security clearances granted pursuant to them; and may issue such orders requiring the disposal of classified matter received
(h) Refusal to grant access to restricted data or national security information.
(1) The Commission will not grant access to restricted data or national security information unless it determines that the granting of access will not be inimical to the common defense and security.
(2) Access to Restricted Data or National Security Information which has been received by the Commission from another Government agency will not be granted by the Commission if the originating agency determines in writing that access should not be granted. The Commission will consult the originating agency prior to granting access to such data or information received from another Government agency.
It is the obligation of all parties in a proceeding subject to this part to avoid, where practicable, the introduction of Restricted Data or National Security Information into the proceeding. This obligation rests on each party whether or not all other parties have the required security clearance.participants, and the LSS Administration.
(a) If, at the time of publication of a notice of hearing, it appears to the staff that it will be impracticable for it to avoid the introduction of Restricted Data or National Security Information into the proceeding, it will file a notice of intent to introduce Restricted Data or National Security Information.
(b) If, at the time of filing of an answer to the notice of hearing it appears to the party filing that it will be impracticable for the party to avoid the introduction of Restricted Data or National Security Information into the proceeding, the party shall state in the answer a notice of intent to introduce Restricted Data or National Security Information into the proceeding.
(c) If, at any later stage of a proceeding, it appears to any party that it will be impracticable to avoid the introduction of Restricted Data or National Security Information into the proceeding, the party shall give to the other parties prompt written notice of intent to introduce Restricted Data or National Security Information into the proceeding.
(d) Restricted Data or National Security Information shall not be introduced into a proceeding after publication of a notice of hearing unless a notice of intent has been filed in accordance with § 2.908, except as permitted in the discretion of the presiding officer when it is clear that no party or the public interest will be prejudiced.
(a) A party who intends to introduce Restricted Data or other National Security Information shall file a notice of intent with the Secretary. The notice shall be unclassified and, to the extent consistent with classification requirements, shall include the following:
(1) The subject matter of the Restricted Data or other National Security Information which it is anticipated will be involved;
(2) The highest level of classification of the information (confidential, secret, or other);
(3) The stage of the proceeding at which he anticipates a need to introduce the information; and
(4) The relevance and materiality of the information to the issues on the proceeding.
(b) In the discretion of the presiding officer, such notice, when required by § 2.907(c), may be given orally on the record.
In any proceeding subject to this part where a party gives a notice of intent to introduce Restricted Data or other National Security Information, and the presiding officer determines that any other interested party does not have
(a) Rearrange the normal order of the proceeding in a manner which gives such interested parties an opportunity to obtain required security clearances with minimum delay in the conduct of the proceeding.
(b) Suspend the proceeding or any portion of it until all interested parties have had opportunity to obtain required security clearances. No proceeding shall be suspended for such reasons for more than 100 days except with the consent of all parties or on a determination by the presiding officer that further suspension of the proceeding would not be contrary to the public interest.
(c) Take such other action as he determines to be in the best interest of all parties and the public.
(a) Whenever Restricted Data or other National Security Information is introduced into a proceeding, the party offering it shall submit to the presiding officer and to all parties to the proceeding an unclassified statement setting forth the information in the classified matter as accurately and completely as possible.
(b) In accordance with such procedures as may be agreed upon by the parties or prescribed by the presiding officer, and after notice to all parties and opportunity to be heard thereon, the presiding officer shall determine whether the unclassified statement or any portion of it, together with any appropriate modifications suggested by any party, may be substituted for the classified matter or any portion of it without prejudice to the interest of any party or to the public interest.
(c) If the presiding officer determines that the unclassified statement, together with such unclassified modifications as he finds are necessary or appropriate to protect the interest of other parties and the public interest, adequately sets forth information in the classified matter which is relevant and material to the issues in the proceeding, he shall direct that the classified matter be excluded from the record of the proceeding. His determination will be considered by the Commission as a part of the decision in the event of review.
(d) If the presiding officer determines that an unclassified statement does not adequately present the information contained in the classified matter which is relevant and material to the issues in the proceeding, he shall include his reasons in his determination. This determination shall be included as part of the record and will be considered by the Commission in the event of review of the determination.
(e) The presiding officer may postpone all or part of the procedures established in this section until the reception of all other evidence has been completed. Service of the unclassified statement required in paragraph (a) of this section shall not be postponed if any party does not have access to Restricted Data or other National Security Information.
A presiding officer shall not receive any Restricted Data or other National Security Information in evidence unless:
(a) The relevance and materiality of the Restricted Data or other National Security Information to the issues in the preceeding, and its competence, are clearly established; and
(b) The exclusion of the Restricted Data or other National Security Information would prejudice the interests of a party or the public interest.
In considering the weight and effect of any Restricted Data or other National Security Information received in evidence to which an interested party has not had opportunity to receive access, the presiding officer and the Commission shall give to such evidence such weight as is appropriate under the circumstances, taking into consideration any lack of opportunity to rebut or impeach the evidence.
At the close of the reception of evidence, the presiding officer shall review the record and shall direct that any Restricted Data or other National Security Information be expunged from the record where such expunction would not prejudice the interests of a party or the public interest. Such directions by the presiding officer will be considered by the Commission in the event of review of the determinations of the presiding officer.
The rules in this subpart govern the procedure for applications for a license to receive and possess high-level radioactive waste at a geologic repository operations area noticed pursuant to § 2.101(f)(8) or § 2.105(a)(5). The procedures in this subpart take precedence over the 10 CFR Part 2, subpart G, rules of general applicability, except for the following provisions: §§ 2.702, 2.703, 2.704, 2.707, 2.711, 2.713, 2.715, 2.715a, 2.717, 2.718, 2.720, 2.721, 2.722, 2.732, 2.733, 2.734, 2.742, 2.743, 2.750, 2.751, 2.753, 2.754, 2.755, 2.756, 2.757, 2.758, 2.759, 2.760, 2.761, 2.763, 2.770, 2.771, 2.772, 2.780, 2.781, 2.786, 2.788, and 2.790.
(a) Subject to the exclusions in § 2.1005 and paragraphs (b) and (c) of this section, DOE shall make available, no later than six months in advance of submitting its license application to receive and possess high-level radioactive waste at a geologic repository operations area, the NRC shall make available no later than thirty days after the DOE certification of compliance under § 2.1009(b), and each other potential party, interested governmental participant or party shall make available no later than ninety days after the DOE certification of compliance under § 2.1009(b)—
(1) An electronic file including bibliographic header for all documentary material (including circulated drafts but excluding preliminary drafts) generated by, or at the direction of, or acquired by, a potential party, interested governmental participant, or party. Concurrent with the production of the electronic file will be an authentication statement that indicates where an authenticated image copy of the document can be obtained.
(2) In electronic image format, subject to the claims of privilege in § 2.1006, graphic-oriented documentary material that includes raw data, computer runs, computer programs and codes, field notes, laboratory notes, maps, diagrams and photographs, which have been printed, scripted, or hand written. Text embedded within these documents need not be separately entered in searchable full text. A bibliographic header must be provided for all graphic-oriented documentary material. Graphic-oriented documents may include—
(i) Calibration procedures, logs, guidelines, data and discrepancies;
(ii) Gauge, meter and computer settings;
(iii) Probe locations;
(iv) Logging intervals and rates;
(v) Data logs in whatever form captured;
(vi) Text data sheets;
(vii) Equations and sampling rates;
(viii) Sensor data and procedures;
(ix) Data Descriptions;
(x) Field and laboratory notebooks;
(xi) Analog computer, meter or other device print-outs;
(xii) Digital computer print-outs;
(xiii) Photographs;
(xiv) Graphs, plots, strip charts, sketches;
(xv) Descriptive material related to the information identified in this paragraph.
(3) In an electronic file, subject to the claims of privilege in § 2.1006, only a bibliographic header for each item of documentary material that is not suitable for image or searchable full text.
(4) An electronic bibliographic header for each documentary material—
(i) For which a claim of privilege is asserted;
(ii) Which constitutes confidential financial or commercial information; or
(iii) Which constitutes safeguards information under § 73.21 of this chapter.
(b) Basic licensing documents generated by DOE, such as the Site Characterization Plan, the Environmental Impact Statement, and the license application, or by NRC, such as the Site Characterization Analysis, and the Safety Evaluation Report, shall be made available in electronic form by the respective agency that generated the document.
(c) The participation of the host State in the pre-license application phase shall not affect the State's ability to exercise its disapproval rights under section 116(b)(2) of the Nuclear Waste Policy Act, as amended, 42 U.S.C. 10136(b)(2).
(d) This subpart shall not affect any independent right of a potential party, interested governmental participant or party to receive information.
Any document that has not been provided to other parties in electronic form must be identified in an electronic notice and made available for inspection and copying by the potential party, interested governmental participant, or party responsible for the submission of the document within five days after it has been requested unless some other time is approved by the Pre-License Application Presiding Officer or the Presiding Officer designated for the high-level waste proceeding. The time allowed under this paragraph will be stayed pending Officer action on a motion to extend the time.
The following material is excluded from the requirement to provide electronic access, either pursuant to § 2.1003, or through derivative discovery pursuant to § 2.1019(i)—
(a) Official notice materials;
(b) Reference books and text books;
(c) Material pertaining exclusively to administration, such as material related to budgets, financial management, personnel, office space, general distribution memoranda, or procurement, except for the scope of work on a procurement related to repository siting, construction, or operation, or to the transportation of spent nuclear fuel or high-level waste;
(d) Press clippings and press releases;
(e) Junk mail;
(f) References cited in contractor reports that are readily available;
(g) Classified material subject to subpart I of this part;
(h) Readily available references, such as journal articles and proceedings, which may be subject to copyright.
(a) Subject to the requirements in § 2.1003(a)(4), the traditional discovery privileges recognized in NRC adjudicatory proceedings and the exceptions from disclosure in § 2.790 may be asserted by potential parties, interested governmental participants, and parties. In addition to Federal agencies, the deliberative process privilege may also be asserted by State and local government entities and Indian Tribes.
(b) Any document for which a claim of privilege is asserted, but is denied in whole or in part by the Pre-License Application Presiding Officer or the Presiding Officer, must be provided in electronic form by the party, interested governmental participant, or potential party that asserted the claim to—
(1) The other participants; or
(2) To the Pre-License Application Presiding Officer or to the Presiding Officer, for entry into a Protective Order file, if the Pre-License Application Presiding Officer or the Presiding Officer so directs under §§ 2.1010(b) or 2.1018(c).
(c) Notwithstanding any availability of the deliberative process privilege under paragraph (a) of this section, circulated drafts not otherwise privileged shall be provided for electronic access pursuant to § 2.1003(a).
(a)(1) A system to provide electronic access to the Licensing Support Network shall be provided at the headquarters of DOE, and at all DOE Local Public Document Rooms established in the vicinity of the likely candidate site for a geologic repository, beginning in the pre-license application phase.
(2) A system to provide electronic access to the Licensing Support Network shall be provided at the NRC Web site,
(3) [Reserved]
(b) Public availability of paper and electronic copies of the records of NRC and DOE, as well as duplication fees, and fee waiver for those records, is governed by the regulations of the respective agencies.
(a) Each potential party, interested governmental participant, or party shall—
(1) Designate an official who will be responsible for administration of its responsibility to provide electronic files of documentary material ;
(2) Establish procedures to implement the requirements in § 2.1003;
(3) Provide training to its staff on the procedures for implementation of the responsibility to provide electronic files of documentary material;
(4) Ensure that all documents carry the submitter's unique identification number;
(5) Cooperate with the advisory review process established by the NRC under § 2.1011(d).
(b) The responsible official designated under paragraph (a)(1) of this section shall certify to the Pre-License Application Presiding Officer that the procedures specified in paragraph (a)(2) of this section have been implemented, and that to the best of his or her knowledge, the documentary material specified in § 2.1003 has been identified and made electronically available. The initial certification must be made at the time the participant is required to comply with § 2.1003. The responsible official for the DOE shall also update this certification at the time DOE submits the license application.
(a)(1) The Commission may designate one or more members of the Commission, or an atomic safety and licensing board, or a named officer who has been delegated final authority on the matter to serve as the Pre-License Application Presiding Officer to rule on disputes over the electronic availability of documents during the pre-license application phase, including disputes relating to privilege, and disputes relating to the implementation of the recommendations of the Advisory Review Panel established under § 2.1011(d).
(2) The Pre-License Application Presiding Officer shall be designated at such time during the pre-license application phase as the Commission finds it appropriate, but in any event no later than fifteen days after the DOE certification of initial compliance under § 2.1009(b).
(b) The Pre-License Application Presiding Officer shall rule on any claim of document withholding to determine—
(1) Whether it is documentary material within the scope of this subpart;
(2) Whether the material is excluded under § 2.1005;
(3) Whether the material is privileged or otherwise excepted from disclosure under § 2.1006;
(4) If privileged, whether it is an absolute or qualified privilege;
(5) If qualified, whether the document should be disclosed because it is necessary to a proper decision in the proceeding;
(6) Whether the material should be disclosed under a protective order containing such protective terms and conditions (including affidavits of nondisclosure) as may be necessary and appropriate to limit the disclosure to potential participants, interested governmental participants and parties in the proceeding, or to their qualified witnesses and counsel. When Safeguards Information protected from disclosure under section 147 of the Atomic Energy Act of 1954, as amended, is received and possessed by a potential party, interested governmental participant, or party, other than the Commission staff, it shall also be protected according to the requirements of § 73.21 of this chapter. The Pre-License Application Presiding Officer may also prescribe such additional procedures as will effectively safeguard and prevent disclosure of Safeguards Information to unauthorized persons with minimum impairment of the procedural rights which would be available if Safeguards Information were not involved. In addition to any other sanction that may be imposed by the Pre-License Application Presiding Officer for violation of an order pertaining to the disclosure of Safeguards Information protected from disclosure under section 147 of the
(c) Upon a final determination that the material is relevant, and not privileged, exempt from disclosure, or otherwise exempt from production under § 2.1005, the potential party, interested governmental participant, or party who asserted the claim of withholding must make the document available in accordance with the provisions of this subpart within five days.
(d) The service of all pleadings and answers, orders, and decisions during the pre-license application phase shall be made according to the procedures specified in § 2.1013(c) and entered into the pre-license application electronic docket.
(e) The Pre-License Application Presiding Officer shall possess all the general powers specified in §§ 2.721(c) and 2.718.
(f) The Commission, in designating the Pre-License Application Presiding Officer in accordance with paragraphs (a) (1) and (2) of this section, shall specify the jurisdiction of the Officer.
(a) Electronic document production and the electronic docket are subject to the provisions of this subpart.
(b)(1) The NRC, DOE, parties, and potential parties participating in accordance with the provision of this subpart shall be responsible for obtaining the computer system necessary to comply with the requirements for electronic document production and service.
(2) The NRC, DOE, parties, and potential parties participating in accordance with the provision of this subpart shall comply with the following standards in the design of the computer systems necessary to comply with the requirements for electronic document production and service:
(i) The participants shall make textual (or, where non-text, image) versions of their documents available on a web accessible server which is able to be canvassed by web indexing software (i.e., a “robot”, “spider”, “crawler”) and the participant system must make both data files and log files accessible to this software.
(ii) The participants shall make bibliographic header data available in an HTTP (Hypertext Transfer Protocol) accessible, ODBC (Open Database Connectivity) and SQL (Structured Query Language)-compliant (ANSI IX3.135-1992/ISO 9075-1992) database management system (DBMS). Alternatively, the structured data containing the bibliographic header may be made available in a standard database readable (e.g., XML (Extensible Markup Language
(iii) Textual material must be formatted to comply with the ISO/IEC 8859-1 character set and be in one of the following acceptable formats: ASCII, native word processing (Word, WordPerfect), PDF Normal, or HTML.
(iv) Image files must be formatted as TIFF CCITT G4 for bi-tonal images or PNG (Portable Network Graphics) per [http://www.w3.org/TR/REC-png-multi.html]) format for grey-scale or color images, or PDF (Portable Document Format—Image). TIFF, PDF, or PNG images will be stored at 300 dpi (dots per inch) or greater, grey scale images at 150 dpi or greater with eight bits of tonal depth, and color images at 150 dpi or greater with 24 bits of color depth. Images found on participant machines will be stored as single image-per-page to facilitate retrieval of no more than a single page, or alternatively, images may be stored in an image-per-document format if software is incorporated in the web server that allows image-per-page representation and delivery.
(v) The participants shall programmatically link, preferably via hyperlink or some other automated process, the bibliographic header record with the text or image file it represents. Each participant's system
(vi) To facilitate data exchange, participants shall adhere to hardware and software standards, including, but not limited to:
(A) Network access must be HTTP/1.1 [http://www.faqs.org/rfcs/rfc2068.html] over TCP (Transmission Control Protocol, [http://www.faqs.org/rfcs/rfc793.html]) over IP (Internet Protocol, [http://www.faqs.org/rfcs/rfc791.html]).
(B) Associating server names with IP addresses must follow the DNS (Domain Name System), [http://www.faqs.org/rfcs/rfc1034.html] and [http://www.faqs.org/rfcs/rfc1035.html].
(C) Web page construction must be HTML [http://www.w3.org/TR/REC-html40/].
(D) Electronic mail (e-mail) exchange between e-mail servers must be SMTP (Simple Mail Transport Protocol, [http://www.faqs.org/rfcs/rfc821.html]).
(E) Format of an electronic mail message must be per [http://www.faqs.org/rfcs/rfc822.html] optionally extended by MIME (Multipurpose Internet MailExtensions) per [http://www.faqs.org/rfcs/rfc2045.html]) to accommodate multipurpose e-mail.
(c) The Licensing Support Network shall be coordinated by the LSN Administrator, who shall be designated before the start of the pre-license application phase. The LSN Administrator shall have the responsibility to—
(1) Identify technical and policy issues related to implementation of the LSN for LSN Advisory Review Panel and Commission consideration;
(2) Address the consensus advice of the LSN Advisory Review Panel under paragraph (e)(1) of this section that is consistent with the requirements of this subpart;
(3) Identify any problems experienced by participants regarding LSN availability, including the availability of individual participant's data, and provide a recommendation to resolve any such problems to the participant(s) and the Pre-License Application Presiding Officer relative to the resolution of any disputes regarding LSN availability, including disputes on the availability of an individual participant's data;
(4) Identify any problems regarding the integrity of documentary material certified in accordance with § 2.1009(b) by the participants to be in the LSN, and provide a recommendation to resolve any such problems to the participant(s) and the Pre-License Application Presiding Officer relative to the resolution of any disputes regarding the integrity of documentary material;
(5) Provide periodic reports to the Commission on the status of LSN functionality and operability.
(6) Evaluate LSN participant compliance with the basic design standards in paragraph (b)(2) of this section, and provide for individual variances from the design standards to accommodate changes in technology or problems identified during initial operability testing of the individual documentary collection websites or the “central LSN site”.
(7) Issue guidance for LSN participants on how best to comply with the design standards in paragraph (b)(2) of this section.
(d) The Secretary of the Commission shall reconstitute the LSS Advisory Review Panel as the LSN Advisory Review Panel, composed of the interests currently represented on the LSS Advisory Review Panel. The Secretary of the Commission shall have the authority to appoint additional representatives to the LSN Advisory Review Panel consistent with the requirements of the Federal Advisory Committee Act, 5 U.S.C. app. I, giving particular consideration to potential parties, parties, and interested governmental participants who were not members of the NRC HLW Licensing Support System Advisory Review Panel.
(e)(1) The LSN Advisory Review Panel shall provide advice to—
(i) NRC on the fundamental issues of the type of computer system necessary to access the Licensing Support Network effectively under paragraph (b) of this section; and
(ii) The Secretary of the Commission on the operation and maintenance of the electronic docket established for the HLW geologic repository licensing proceeding under the Commission's Rules of Practice (10 CFR part 2).
(iii) The LSN Administrator on solutions to improve the functioning of the LSN;
(2) The responsibilities of the LSN Advisory Review Panel shall include advice on—
(i) Format standards for providing electronic access to the documentary material certified by each participant to be made available in the LSN to the other parties, interested governmental participants, or potential parties;
(ii) The procedures and standards for the electronic transmission of filings, orders, and decisions during both the pre-license application phase and the high-level waste licensing proceeding;
(iii) Other duties as specified in this subpart or as directed by the Secretary of the Commission.
(a) If the Department of Energy fails to make its initial certification at least six months prior to tendering the application, upon receipt of the tendered application, notwithstanding the provisions of § 2.101(f)(3), the Director of the NRC's Office of Nuclear Material Safety and Safeguards will not docket the application until at least six months have elapsed from the time of certification. The Director may determine that the tendered application is not acceptable for docketing under this subpart if the application is not accompanied by an updated certification pursuant to § 2.1009(b), or if the Secretary of the Commission determines that the application cannot be effectively accessed through the Commission's electronic docket system.
(b)(1) A person, including a potential party given access to the Licensing Support Network under this subpart, shall not be granted party status under § 2.1014, or status as an interested governmental participant under § 2.715(c), if it cannot demonstrate substantial and timely compliance with the requirements of § 2.1003 at the time it requests participation in the high-level waste licensing proceeding under § 2.1014 or § 2.715(c).
(2) A person denied party status or interested governmental participant status under paragraph (b)(1) of this section may request party status or interested governmental participant status upon a showing of subsequent compliance with the requirements of § 2.1003 of this subpart. Admission of such a party or interested governmental participant under § 2.1014 of this subpart or § 2.715(c) of this part, respectively, shall be conditioned on accepting the status of the proceeding at the time of admission.
(c) The Presiding Officer shall not make a finding of substantial and timely compliance pursuant to paragraph (b) of this section for any person who is not in compliance with all applicable orders of the Pre-License Application Presiding Officer designated pursuant to § 2.1010.
(a)(1) Pursuant to § 2.702, the Secretary of the Commission will maintain the official docket of the proceeding on the application for a license to receive and possess waste at a geologic repository operations area.
(2) Commencing with the docketing in an electronic form of the license application to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter, the Secretary of the Commission, upon determining that the application can be properly accessed under the Commission's electronic docket rules, will establish an electronic docket to contain the official record materials of the high-level radioactive waste licensing proceeding in searchable full text, or, for material that is not suitable for entry in searchable full text, by header and image, as appropriate.
(b) Absent good cause, all exhibits tendered during the hearing must have been made available to the parties in electronic form before the commencement of that portion of the hearing in which the exhibit will be offered. The electronic docket will contain a list of all exhibits, showing where in the transcript each was marked for identification and where it was received into evidence or rejected. Transcripts will be
(c)(1) All filings in the adjudicatory proceeding on the license application to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter shall be transmitted electronically by the submitter to the Presiding Officer, parties, and the Secretary of the Commission, according to established format requirements. Parties and interested governmental participants will be required to use a password security code for the electronic transmission of these documents.
(2) Filings required to be served shall be served upon either the parties and interested governmental participants, or their designated representatives. When a party or interested governmental participant has appeared by attorney, service must be made upon the attorney of record.
(3) Service upon a party or interested governmental participant is completed when the sender receives electronic acknowledgment (“delivery receipt”) that the electronic submission has been placed in the recipient's electronic mailbox.
(4) Proof of service, stating the name and address of the person on whom served and the manner and date of service, shall be shown for each document filed, by—
(i) Electronic acknowledgment (“delivery receipt”);
(ii) The affidavit of the person making the service; or
(iii) The certificate of counsel.
(5) All Presiding Officer and Commission issuances and orders will be transmitted electronically to the parties and interested governmental participants.
(d) Online access to the electronic docket, including a Protective Order File if authorized by a Presiding Officer, shall be provided to the Presiding Officer, the representatives of the parties and interested governmental participants, and the witnesses while testifying, for use during the hearing. Use of paper copy and other images will also be permitted at the hearing.
(a)(1) Any person whose interest may be affected by a proceeding on the application for a license to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter, and who desires to participate as a party, shall file a written petition for leave to intervene. In a proceeding noticed pursuant to § 2.105, any person whose interest may be affected may also request a hearing. The petition and/or request, and any request to participate under § 2.715(c), shall be filed within thirty days after the publication of the notice of hearing in the
(i) Good cause, if any, for failure to file on time;
(ii) The availability of other means whereby the petitioner's interest will be protected;
(iii) The extent to which the petitioner's participation may reasonably be expected to assist in developing a sound record;
(iv) The extent to which the petitioner's interest will be represented by existing parties;
(v) The extent to which the petitioner's participation will broaden the issues or delay the proceeding.
(2) The petition shall set forth with particularity—
(i) The interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding, including the reasons why petitioner should be permitted to intervene, with particular reference to the factors in paragraph (c) of this section;
(ii) A list of the contentions that petitioner seeks to have litigated in the matter;
(iii) With respect to each contention:
(A) A specific statement of the issue of law or fact to be raised or controverted.
(B) A brief explanation of the basis of the contention.
(C) A concise statement of the alleged facts or expert opinion that support the contention and on which the petitioner intends to rely in proving the contention at the hearing, together with references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion.
(D) Sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. This showing must include reference to the specific documentary material that provides a basis for the contention, or if the petitioner believes that any documentary material fails to contain information on a relevant matter as required by law, the identification of each failure and the supporting reasons for the petitioner's belief. In determining whether a genuine dispute exists on a material issue of law or fact, a dispositive factor shall be whether the contention, if proven, would be of no consequence in the proceeding because it would not entitle the petitioner to relief.
(E) The specific regulatory or statutory requirement to which the contention is relevant.
(3) Any petitioner who fails to satisfy paragraphs (a)(2) (ii) and (iii) of this section with respect to at least one contention shall not be permitted to participate as a party.
(4) Any party may amend its contentions specified in paragraph (a)(2)(ii) of this section. The Presiding Officer shall rule on any petition to amend such contentions based on the balancing of the factors specified in paragraph (a)(1) of this section and a showing that a significant safety or environmental issue is involved or that the amended contention raises a material issue related to the performance evaluation anticipated by §§ 60.112 and 60.113 or §§ 63.112 and 63.113 of this chapter.
(b) Any party or interested governmental participant may file an answer to a petition for leave to intervene or a petition to amend contentions within twenty days after service of the petition.
(c) Subject to paragraph (a)(3) of this section, the Commission, or the Presiding Officer designated to rule on petitions to intervene and/or requests for hearing shall permit intervention, in any hearing on an application for a license to receive and possess high-level radioactive waste at a geologic repository operations area, by an affected unit of local government as defined in section 2(31) of the Nuclear Waste Policy Act of 1982, as amended, 42 U.S.C. 10101. In all other circumstances, the Commission or Presiding Officer shall, in ruling on a petition for leave to intervene, consider the following factors, among other things:
(1) The nature of the petitioner's right under the Atomic Energy Act to be made a party to the proceeding;
(2) The nature and extent of the petitioner's property, financial, or other interest in the proceeding;
(3) The possible effect of any order that may be entered in the proceeding on the petitioner's interest;
(4) The failure of the petitioner to participate as a potential party in the pre-license application phase.
(5) In determining whether a genuine dispute exists on a material issue of law or fact, whether the contention, if proven, would be of no consequence in the proceeding because it would not entitle petitioner to relief.
(d) An order permitting intervention and/or directing a hearing may be conditioned on such terms as the Commission, or the designated Presiding Officer may direct in the interests of:
(1) Restricting irrelevant, duplicative, or repetitive evidence and argument,
(2) Having common interests represented by a spokesman, and
(3) Retaining authority to determine priorities and control the compass of the hearing.
(e) In any case in which, after consideration of the factors set forth in paragraph (c) of this section, the Commission or the Presiding Officer finds that the petitioner's interest is limited to one or more of the issues involved in the proceeding, any order allowing intervention shall limit the petitioner's participation accordingly.
(f) A person permitted to intervene becomes a party to the proceeding, subject to any limitations imposed pursuant to paragraph (e) of this section.
(g) Unless otherwise expressly provided in the order allowing intervention, the granting of a petition for leave to intervene does not change or enlarge the issues specified in the notice of hearing.
(h) If the Commission or the Presiding Officer determines that any of the admitted contentions constitute pure issues of law, those contentions must be decided on the basis of briefs or oral argument according to a schedule determined by the Commission or the Presiding Officer.
(a) No appeals from any Pre-License Application Presiding Officer or Presiding Officer order or decision issued under this subpart are permitted, except as prescribed in paragraphs (b), (c), and (d) of this section.
(b) A notice of appeal from (1) a Pre-License Application Presiding Officer order issued pursuant to § 2.1010, (2) a Presiding Officer First or Second Prehearing Conference Order issued pursuant to § 2.1021 or § 2.1022, (3) a Presiding Officer order granting or denying a motion for summary disposition issued in accordance with § 2.1025 of this part, or (4) a Presiding Officer order granting or denying a petition to amend one or more contentions pursuant to § 2.1014(a)(4), must be filed with the Commission no later than (10) days after service of the order. A supporting brief must accompany the notice of appeal. Any other party, interested governmental participant, or potential party may file a brief in opposition to the appeal no later than ten days after service of the appeal.
(c) Appeals from a Presiding Officer initial decision or partial initial decision must be filed and briefed before the Commission in accordance with the following requirements.
(1)
(i) The party taking the appeal; and
(ii) The decision being appealed.
(2)
(3)
(4)
(i) An appellant's brief must clearly identify the errors of fact or law that are the subject of the appeal. An intervenor-appellant's brief must be confined to issues which the intervenor-appellant placed in controversy or sought to place in controversy in the proceeding. For each issue appealed, the precise portion of the record relied upon in support of the assertion of error must also be provided.
(ii) Each responsive brief must contain a reference to the precise portion of the record which supports each factual assertion made.
(5)
(6)
(7)
(d) When, in the judgment of a Pre-License Application Presiding Officer or Presiding Officer, prompt appellate review of an order not immediately appealable under paragraph (b) of this section is necessary to prevent detriment to the public interest or unusual delay or expense, the Pre-License Application Presiding Officer or Presiding Officer may refer the ruling promptly to the Commission, and shall provide notice of this referral to the parties, interested governmental participants, or potential parties. The parties, interested governmental participants, or potential parties may also request that the Pre-License Application Presiding Officer or Presiding Officer certify, pursuant to § 2.718(i) of this part, rulings not immediately appealable under paragraph (b) of this section.
(e) Unless otherwise ordered, the filing of an appeal, petition for review, referral, or request for certification of a ruling shall not stay the proceeding or extend the time for the performance of any act.
(a) All motions shall be addressed to the Commission or, when a proceeding is pending before a Presiding Officer, to the Presiding Officer. All motions, unless made orally on the record, shall be filed according to the provisions of § 2.1013(c) of this subpart.
(b) A motion shall state with particularity the grounds and the relief sought, and shall be accompanied by any affidavits or other evidence relied on, and, as appropriate, a proposed form of order.
(c) Within ten days after service of a motion a party, potential party, or interested governmental participant may file an answer in support of or in opposition to the motion, accompanied by affidavits or other evidence. The moving party shall have no right to reply, except as permitted by the Presiding Officer or the Secretary or the Assistant Secretary.
(d) The Presiding Officer may dispose of motions either by order or by ruling orally during the course of a prehearing conference or hearing.
(e) Where the motion in question is a motion to compel discovery under § 2.720(h)(2) of this part or § 2.1018(f) of this subpart, parties, potential parties, and interested governmental participants may file answers to the motion pursuant to paragraph (c) of this section. The Presiding Officer in its discretion, may order that the answer be given orally during a telephone conference or other prehearing conference, rather than filed electronically. If responses are given over the telephone the Presiding Officer shall issue a written order on the motion which summarizes the views presented by the parties, potential parties, and interested governmental participants unless the conference has been transcribed. This does not preclude the Presiding Officer from issuing a prior oral ruling on the matter which is effective at the time of its issuance, provided that the terms of the ruling are incorporated in the subsequent written order.
In computing any period of time, the day of the act, event, or default after which the designated period of time begins to run is not included. The last day of the period so computed is included unless it is a Saturday, Sunday, or legal holiday at the place where the action or event is to occur, in which event the period runs until the end of the next day which is neither a Saturday, Sunday, nor holiday. Whenever a party, potential party, or interested governmental participant, has the right or is required to do some act within a prescribed period after the service of a notice or other document upon it, one day shall be added to the prescribed period. If the electronic docket is unavailable for more than
(a)(1) Parties, potential parties, and interested governmental participants in the high-level waste licensing proceeding may obtain discovery by one or more of the following methods:
(i) Access to the documentary material made available pursuant to § 2.1003;
(ii) Entry upon land for inspection, access to raw data, or other purposes pursuant to § 2.1020;
(iii) Access to, or the production of, copies of documentary material for which bibliographic headers only have been submitted pursuant to § 2.1003(a);
(iv) Depositions upon oral examination pursuant to § 2.1019;
(v) Requests for admission pursuant to § 2.742;
(vi) Informal requests for information not made electronically available, such as the names of witnesses and the subjects they plan to address; and
(vii) Interrogatories and depositions upon written questions, as provided in paragraph (a)(2) of this section.
(2) Interrogatories and depositions upon written questions may be authorized by order of the discovery master appointed under paragraph (g) of this section, or if no discovery master has been appointed, by order of the Presiding Officer, in the event that the parties are unable, after informal good faith efforts, to resolve a dispute in a timely fashion concerning the production of information.
(b)(1) Parties, potential parties, and interested governmental participants, pursuant to the methods set forth in paragraph (a) of this section, may obtain discovery regarding any matter, not privileged, which is relevant to the licensing of the likely candidate site for a geologic repository, whether it relates to the claim or defense of the person seeking discovery or to the claim or defense of any other person. Except for discovery pursuant to §§ 2.1018(a)(2) and 2.1019 of this subpart, all other discovery shall begin during the pre-license application phase. Discovery pursuant to §§ 2.1018(a)(2) and 2.1019 of this subpart shall begin after the issuance of the first pre-hearing conference order under § 2.1021 of this subpart, and shall be limited to the issues defined in that order or subsequent amendments to the order. It is not ground for objection that the information sought will be inadmissible at the hearing if the information sought appears reasonably calculated to lead to the discovery of admissible evidence.
(2) A party, potential party, or interested governmental participant may obtain discovery of documentary material otherwise discoverable under paragraph (b)(1) of this section and prepared in anticipation of, or for the hearing by, or for another party's, potential party's, or interested governmental participant's representative (including its attorney, surety, indemnitor, insurer, or similar agent) only upon a showing that the party, potential party, or interested governmental participant seeking discovery has substantial need of the materials in the preparation of its case and that it is unable without undue hardship to obtain the substantial equivalent of the materials by other means. In ordering discovery of these materials when the required showing has been made, the Presiding Officer shall protect against disclosure of the mental impressions, conclusions, opinions, or legal theories of an attorney or other representative of a party, potential party, or interested governmental participant concerning the proceeding.
(c) Upon motion by a party, potential party, interested governmental participant, or the person from whom discovery is sought, and for good cause shown, the Presiding Officer may make any order that justice requires to protect a party, potential party, interested governmental participant, or other person from annoyance, embarrassment, oppression, or undue burden, delay, or expense, including one or more of the following:
(1) That the discovery not be had;
(2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place;
(3) That the discovery may be had only by a method of discovery other
(4) That certain matters not be inquired into, or that the scope of discovery be limited to certain matters;
(5) That discovery be conducted with no one present except persons designated by the Presiding Officer;
(6) That, subject to the provisions of § 2.790 of this part, a trade secret or other confidential research, development, or commercial information not be disclosed or be disclosed only in a designated way;
(7) That studies and evaluations not be prepared.
(d) Except as provided in paragraph (b) of this section, and unless the Presiding Officer upon motion, for the convenience of parties, potential parties, interested governmental participants, and witnesses and in the interest of justice, orders otherwise, methods of discovery may be used in any sequence, and the fact that a party, potential party, or interested governmental participant is conducting discovery, whether by deposition or otherwise, shall not operate to delay any other party's, potential party's, or interested governmental participant's discovery.
(e) A party, potential party, or interested governmental participant who has made available in electronic form all material relevant to any discovery request or who has responded to a request for discovery with a response that was complete when made is under no duty to supplement its response to include information thereafter acquired, except as follows:
(1) To the extent that written interrogatories are authorized pursuant to paragraph (a)(2) of this section, a party or interested governmental participant is under a duty to seasonably supplement its response to any question directly addressed to (i) the identity and location of persons having knowledge of discoverable matters, and (ii) the identity of each person expected to be called as an expert witness at the hearing, the subject matter on which the witness is expected to testify, and the substance of the witness’ testimony.
(2) A party, potential party, or interested governmental participant is under a duty seasonably to amend a prior response if it obtains information upon the basis of which (i) it knows that the response was incorrect when made, or (ii) it knows that the response though correct when made is no longer true and the circumstances are such that a failure to amend the response is in substance a knowing concealment.
(3) A duty to supplement responses may be imposed by order of the Presiding Officer or agreement of the parties, potential parties, and interested governmental participants.
(f)(1) If a deponent of a party, potential party, or interested governmental participant upon whom a request for discovery is served fails to respond or objects to the request, or any part thereof, the party, potential party, or interested governmental participant submitting the request or taking the deposition may move the Presiding Officer, within five days after the date of the response or after failure to respond to the request, for an order compelling a response in accordance with the request. The motion shall set forth the nature of the questions or the request, the response or objection of the party, potential party, interested governmental participant, or other person upon whom the request was served, and arguments in support of the motion. For purposes of this paragraph, an evasive or incomplete answer or response shall be treated as a failure to answer or respond. Failure to answer or respond shall not be excused on the ground that the discovery sought is objectionable unless the person, party, potential party, or interested governmental participant failing to answer or respond has applied for a protective order pursuant to paragraph (c) of this section.
(2) In ruling on a motion made pursuant to this section, the Presiding Officer may make such a protective order as it is authorized to make on a motion made pursuant to paragraph (c) of this section.
(3) An independent request for issuance of a subpoena may be directed to a nonparty for production of documents. This section does not apply to requests for the testimony of the NRC regulatory staff pursuant to § 2.720(h)(2)(i) of this part.
(g) The Presiding Officer pursuant to § 2.722 of this part may appoint a discovery master to resolve disputes between parties concerning informal requests for information as provided in paragraphs (a)(1) and (a)(2) of this section.
(a) Any party or interested governmental participant desiring to take the testimony of any person by deposition on oral examination shall, without leave of the Commission or the Presiding Officer, give reasonable notice in writing to every other party and interested governmental participant, to the person to be examined, and to the Presiding Officer of the proposed time and place of taking the deposition; the name and address of each person to be examined, if known, or if the name is not known, a general description sufficient to identify him or her or the class or group to which he or she belongs, the matters upon which each person will be examined and the name or descriptive title and address of the officer before whom the deposition is to be taken.
(b) Within the United States, a deposition may be taken before any officer authorized to administer oaths by the laws of the United States or of the place where the examination is held. Outside of the United States, a deposition may be taken before a secretary of an embassy or legation, a consul general, vice consul or consular agent of the United States, or a person authorized to administer oaths designated by the Commission. Depositions may be conducted by telephone or by video teleconference at the option of the party or interested governmental participant taking the deposition.
(c) The deponent shall be sworn or shall affirm before any questions are put to him or her. Examination and cross-examination shall proceed as at a hearing. Each question propounded shall be recorded and the answer taken down in the words of the witness. Objections on questions of evidence shall be noted in short form without the arguments. The officer shall not decide on the competency, materiality, or relevancy of evidence but shall record the evidence subject to objection. Objections on questions of evidence not made before the officer shall not be deemed waived unless the ground of the objection is one which might have been obviated or removed if presented at that time.
(d) When the testimony is fully transcribed, the deposition shall be submitted to the deponent for examination and signature unless the deponent is ill or cannot be found or refuses to sign. The officer shall certify the deposition or, if the deposition is not signed by the deponent, shall certify the reasons for the failure to sign, and shall promptly transmit an electronic copy of the deposition to the Secretary of the Commission for entry into the electronic docket.
(e) Where the deposition is to be taken on written questions as authorized under § 2.1018(a)(2), the party or interested governmental participant taking the deposition shall electronically serve a copy of the questions, showing each question separately and consecutively numbered, on every other party and interested governmental participant with a notice stating the name and address of the person who is to answer them, and the name, description, title, and address of the officer before whom they are to be asked. Within ten days after service, any other party or interested governmental participant may serve cross-questions. The questions, cross-questions, and answers shall be recorded and signed, and the deposition certified, returned, and transmitted in electronic form to the Secretary of the Commission for entry into the electronic docket as in the case of a deposition on oral examination.
(f) A deposition will not become a part of the evidentiary record in the hearing unless received in evidence. If only part of a deposition is offered in
(g) A deponent whose deposition is taken and the officer taking a deposition shall be entitled to the same fees as are paid for like services in the district courts of the United States, to be paid by the party or interested governmental participant at whose instance the deposition is taken.
(h) The deponent may be accompanied, represented, and advised by legal counsel.
(i)(1) After receiving written notice of the deposition under paragraph (a) or paragraph (e) of this section, and ten days before the scheduled date of the deposition, the deponent shall submit an electronic index of all documents in his or her possession, relevant to the subject matter of the deposition, including the categories of documents set forth in paragraph (i)(2) of this section, to all parties and interested governmental participants. The index shall identify those records which have already been made available electronically. All documents that are not identical to documents already made available electronically, whether by reason of subsequent modification or by the addition of notations, shall be treated as separate documents.
(2) The following material is excluded from the initial requirements of § 2.1003 to be made available electronically, but is subject to derivative discovery under paragraph (i)(1) of this section—
(i) Personal records;
(ii) Travel vouchers;
(iii) Speeches;
(iv) Preliminary drafts;
(v) Marginalia.
(3) Subject to paragraph (i)(6) of this section, any party or interested governmental participant may request from the deponent a paper copy of any or all of the documents on the index that have not already been provided electronically.
(4) Subject to paragraph (i)(6) of this section, the deponent shall bring a paper copy of all documents on the index that the deposing party or interested governmental participant requests that have not already been provided electronically to an oral deposition conducted pursuant to paragraph (a) of this section, or in the case of a deposition taken on written questions pursuant to paragraph (e) of this section, shall submit such documents with the certified deposition.
(5) Subject to paragraph (i)(6) of this section, a party or interested governmental participant may request that any or all documents on the index that have not already been provided electronically, and on which it intends to rely at hearing, be made electronically available by the deponent.
(6) The deposing party or interested governmental participant shall assume the responsibility for the obligations set forth in paragraphs (i)(1), (i)(3), (i)(4), and (i)(5) of this section when deposing someone other than a party or interested governmental participant.
(j) In a proceeding in which the NRC is a party, the NRC staff will make available one or more witnesses designated by the Executive Director for Operations, for oral examination at the hearing or on deposition regarding any matter, not privileged, which is relevant to the issues in the proceeding. The attendance and testimony of the Commissioners and named NRC personnel at a hearing or on deposition may not be required by the Presiding Officer, by subpoena or otherwise:
(a) Any party, potential party, or interested governmental participant may serve on any other party, potential
(b) The request may be served on any party, potential party, or interested governmental participant without leave of the Commission or the Presiding Officer.
(c) The request shall describe with reasonable particularity the land or other property to be inspected either by individual item or by category. The request shall specify a reasonable time, place, and manner of making the inspection and performing the related acts.
(d) The party, potential party, or interested governmental participant upon whom the request is served shall serve on the party, potential party, or interested governmental participant submitting the request a written response within ten days after the service of the request. The response shall state, with respect to each item or category, that inspection and related activities will be permitted as requested, unless the request is objected to, in which case the reasons for objection shall be stated. If objection is made to part of an item or category, the part shall be specified.
(a) In any proceeding involving an application for a license to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter, the Commission or the Presiding Officer will direct the parties, interested governmental participants, and any petitioners for intervention, or their counsel, to appear at a specified time and place, within seventy days after the notice of hearing is published, or such other time as the Commission or the Presiding Officer may deem appropriate, for a conference to:
(1) Permit identification of the key issues in the proceeding;
(2) Take any steps necessary for further identification of the issues;
(3) Consider all intervention petitions to allow the Presiding Officer to make such preliminary or final determination as to the parties and interested governmental participants, as may be appropriate;
(4) Establish a schedule for further actions in the proceeding; and
(5) Establish a discovery schedule for the proceeding taking into account the objective of meeting the three year time schedule specified in section 114(d) of the Nuclear Waste Policy Act of 1982, as amended, 42 U.S.C. 10134(d).
(b) The Presiding Officer may order any further formal and informal conferences among the parties and interested governmental participants including teleconferences, to the extent that it considers that such a conference would expedite the proceeding.
(c) A prehearing conference held pursuant to this section shall be stenographically reported.
(d) The Presiding Officer shall enter an order which recites the action taken at the conference, the schedule for further actions in the proceeding, and any agreements by the parties, and which identifies the key issues in the proceeding, makes a preliminary or final determination as to the parties and interested governmental participants in the proceeding, and provides for the submission of status reports on discovery.
(a) The Commission or the Presiding Officer in a proceeding on an application for a license to receive and possess high-level radioactive waste at a geologic repository operations area shall direct the parties, interested governmental participants, or their counsel to appear at a specified time and place not later than thirty days after the Safety Evaluation Report is issued by
(1) Any amended contentions submitted under § 2.1014(a)(4) of this subpart;
(2) Simplification, clarification, and specification of the issues;
(3) The obtaining of stipulations and admissions of fact and of the contents and authenticity of documents to avoid unnecessary proof;
(4) Identification of witnesses and the limitation of the number of expert witnesses, and other steps to expedite the presentation of evidence;
(5) The setting of a hearing schedule;
(6) Establishing a discovery schedule for the proceeding taking into account the objective of meeting the three year time schedule specified in section 114(d) of the Nuclear Waste Policy Act of 1982, as amended, 42 U.S.C. 10134(d); and
(7) Such other matters as may aid in the orderly disposition of the proceeding.
(b) A prehearing conference held pursuant to this section shall be stenographically reported.
(c) The Presiding Officer shall enter an order which recites the action taken at the conference and the agreements by the parties, limits the issues or defines the matters in controversy to be determined in the proceeding, sets a discovery schedule, and sets the hearing schedule.
(a) Pending review and final decision by the Commission, an initial decision resolving all issues before the Presiding Officer in favor of issuance or amendment of a construction authorization pursuant to § 60.31 or 63.31 of this chapter or a license to receive and possess high-level radioactive waste at a geologic repository operations area pursuant to § 60.41 or 63.41 of this chapter, will be immediately effective upon issuance except—
(1) As provided in any order issued in accordance with § 2.788 of this part that stays the effectiveness of an initial decision; or
(2) As otherwise provided by the Commission in special circumstances.
(b) The Director of Nuclear Material Safety and Safeguards, notwithstanding the filing or pendency of an appeal or a petition for review pursuant to § 2.1015 of this subpart, promptly shall issue a construction authorization or a license to receive and possess high-level radioactive waste at a geologic respository operations area, or amendments thereto, following an initial decision resolving all issues before the Presiding Officer in favor of the licensing action, upon making the appropriate licensing findings, except—
(1) As provided in paragraph (c) of this section; or
(2) As provided in any order issued in accordance with § 2.788 of this part that stays the effectiveness of an initial decision; or
(3) As otherwise provided by the Commission in special circumstances.
(c)(1) Before the Director of Nuclear Material Safety and Safeguards may issue a construction authorization or a license to receive and possess waste at a geologic repository operations area in accordance with paragraph (b) of this section, the Commission, in the exercise of its supervisory authority over agency proceedings, shall undertake and complete a supervisory examination of those issues contested in the proceeding before the Presiding Officer to consider whether there is any significant basis for doubting that the facility will be constructed or operated with adequate protection of the public health and safety, and whether the Commission should take action to suspend or to otherwise condition the effectiveness of a Presiding Officer decision that resolves contested issues in a proceeding in favor of issuing a construction authorization or a license to receive and possess high-level radioactive waste at a geologic repository operations area. This supervisory examination is not part of the adjudicatory proceeding. The Commission shall notify the Director in writing when its supervisory examination conducted in accordance with this paragraph has been completed.
(2) Before the Director of Nuclear Material Safety and Safeguards issues a construction authorization or a license to receive and possess high-level
(3) No suspension of the effectiveness of a Presiding Officer's initial decision or postponement of the Director's issuance of a construction authorization or license that results from a Commission supervisory examination of contested issues under paragraph (c)(1) of this section or a review of uncontested issues under paragraph (c)(2) of this section will be entered except in writing with a statement of the reasons. Such suspension or postponement will be limited to such period as is necessary for the Commission to resolve the matters at issue. If the supervisory examination results in a suspension of the effectiveness of the Presiding Officer's initial decision under paragraph (c)(1) of this section, the Commission will take review of the decision sua sponte and further proceedings relative to the contested matters at issue will be in accordance with procedures for participation by the DOE, the NRC staff, or other parties and interested governmental participants to the Presiding Officer proceeding established by the Commission in its written statement of reasons. If a postponement results from a review under paragraph (c)(2) of this section, comments on the uncontested matters at issue may be filed by the DOE within ten days of service of the Commission's written statement.
(a) Any party may move, with or without supporting affidavits, for a decision by the Presiding Officer in that party's favor as to all or any part of the matters involved in the proceeding. The moving party shall annex to the motion a separate, short, and concise statement of the material facts as to which the moving party contends that there is no genuine issue to be heard. Motions may be filed at any time. Any other party may file an answer supporting or opposing the motion, with or without affidavits, within twenty (20) days after service of the motion. The party shall annex to any answer opposing the motion a separate, short, and concise, statement of the material facts as to which it is contended there exists a genuine issue to be heard. All material facts set forth in the statement to be filed by the moving party will be deemed to be admitted unless controverted by the statement required to be filed by the opposing party. The opposing party may, within ten (10) days after service, respond in writing to new facts and arguments presented in any statement filed in support of the motion. No further supporting statements or responses thereto may be entertained. The Presiding Officer may dismiss summarily or hold in abeyance motions filed shortly before the hearing commences or during the hearing if the other parties or the Presiding Officer would be required to divert substantial resources from the hearing in order to respond adequately to the motion.
(b) Affidavits must set forth those facts that would be admissible in evidence and show affirmatively that the affiant is competent to testify to the matters stated therein. The Presiding Officer may permit affidavits to be supplemented or opposed by further affidavits. When a motion for summary disposition is made and supported as provided in this section, a party opposing the motion may not rest upon the mere allegations or denials of its answer; its answer by affidavits or as otherwise provided in this section must set forth specific facts showing that there is a genuine issue of fact. If no such answer
(c) The Presiding Officer shall render the decision sought if the filings in the proceeding show that there is no genuine issue as to any material fact and that the moving party is entitled to a decision as a matter of law. However, in any proceeding involving a construction authorization for a geologic repository operations area, the procedure described in this section may be used only for the determination of specific subordinate issues and may not be used to determine the ultimate issue as to whether the authorization must be issued.
(a) Subject to paragraphs (b) and (c) of this section, the Presiding Officer shall adhere to the schedule set forth in appendix D of this part.
(b)(1) Pursuant to § 2.711, the Presiding Officer may approve extensions of no more than 15 days beyond any required time set forth in this subpart for a filing by a party to the proceeding. Except in the case of exceptional and unforseen circumstances, requests for extensions of more than 15 days must be filed no later than 5 days in advance of the required time set forth in this subpart for a filing by a party to the proceeding.
(2) Extensions beyond 15 days must be referred to the Commission. If the Commission does not disapprove the extension within 10 days of receiving the request, the extension will be effective. If the Commission disapproves the extension, the date which was the subject of the extension request will be set for 5 days after the Commission's disapproval action.
(c)(1) The Presiding Officer may delay the issuance of an order up to thirty days beyond the time set forth for the issuance in appendix D.
(2) If the Presiding Officer anticipates that the issuance of an order will not occur until after the thirty day extension specified in paragraph (c)(1) of this section, the Presiding Officer shall notify the Commission at least ten days in advance of the scheduled date for the milestone and provide a justification for the delay.
In any initial decision in a proceeding on an application to receive and possess waste at a geologic repository operations area, the Presiding Officer, other than the Commission, shall make findings of fact and conclusions of law on, and otherwise give consideration to, only those matters put into controversy by the parties and determined to be litigable issues in the proceeding.
The regulations in this subpart establish hybrid hearing procedures, as authorized by section 134 of the Nuclear Waste Policy Act of 1982 (96 Stat. 2230), to be used at the request of any party in certain contested proceedings on applications for a license or license amendment to expand the spent nuclear fuel storage capacity at the site of a civilian nuclear power plant. These procedures are intended to encourage and expedite onsite expansion of spent nuclear fuel storage capacity.
The procedures in this subpart apply to contested proceedings on applications filed after January 7, 1983, for a license or license amendment under part 50 of this chapter, to expand the spent fuel storage capacity at the site of a civilian nuclear power plant, through the use of high density fuel storage racks, fuel rod compaction, the transshipment of spent nuclear fuel to another civilian nuclear power reactor within the same utility system, the construction of additional spent nuclear fuel pool capacity or dry storage
As used in this part:
(a)
(b)
In connection with each application filed after January 7, 1983, for a license or an amendment to a license to expand the spent nuclear fuel storage capacity at the site of a civilian nuclear power plant, for which the Commission has not found that a hearing is required in the public interest, for which an adjudicatory hearing has not yet been convened, and for which a notice of proposed action has not yet been published as of the effective date of this subpart, the Commission will, prior to acting thereon, cause to be published in the
(a)(1) Within ten (10) days after an order granting a request for hearing or petition for leave to intervene, any party may invoke the hybrid hearing procedures in this subpart by requesting an oral argument. Requests for oral argument shall be in writing and shall be filed with the presiding officer. The presiding officer shall grant a timely request for oral argument.
(2) The presiding officer may grant an untimely request for oral argument only upon a showing of good cause by the requesting party for failure to file on time and after providing the other parties an opportunity to respond to the untimely request.
(b) The presiding officer shall issue a written order ruling on any requests for oral argument. If the presiding officer grants a request for oral argument, the order shall include a schedule for discovery and subsequent oral argument with respect to the admitted contentions.
(c) If no party to the proceeding requests oral argument, or if all untimely requests for oral argument are denied, the presiding officer shall conduct the proceeding in accordance with subpart G of 10 CFR part 2.
Discovery shall begin and end at such times as the presiding officer shall order. It is expected that all discovery shall be completed within 90 days. The presiding officer may extend the time for discovery upon good cause shown based on exceptional circumstances and after providing the other parties an opportunity to respond to the request.
(a) Fifteen (15) days prior to the date set for oral argument, each party, including the NRC staff, shall submit to the presiding officer a detailed written summary of all the facts, data, and arguments which are known to the party at such time and on which the party proposes to rely at the oral argument
(b) Only facts and data in the form of sworn written testimony or other sworn written submission may be relied on by the parties during oral argument, and the presiding officer shall consider those facts and data only if they are submitted in that form.
(a) After due consideration of the oral presentation and the written facts and data submitted by the parties and relied on at the oral argument, the presiding officer shall promptly by written order:
(1) Designate any disputed issues of fact, together with any remaining issues of law, for resolution in an adjudicatory hearing; and
(2) Dispose of any issues of law or fact not designated for resolution in an adjudicatory hearing.
(b) No issue of law or fact shall be designated for resolution in an adjudicatory hearing unless the presiding officer determines that:
(1) There is a genuine and substantial dispute of fact which can only be resolved with sufficient accuracy by the introduction of evidence in an adjudicatory hearing; and
(2) The decision of the Commission is likely to depend in whole or in part on the resolution of that dispute.
(c) In making a determination under paragraph (b) of this section, the presiding officer shall not consider:
(1) Any issue relating to the design, construction, or operation of any civilian nuclear power reactor already licensed to operate at the site, or any civilian nuclear power reactor for which a construction permit has been granted at the site, unless the presiding officer determines that any such issue substantially affects the design, construction, or operation of the facility or activity for which a license application, authorization, or amendment to expand the spent nuclear fuel storage capacity is being considered; or
(2) Any siting or design issue fully considered and decided by the Commission in connection with the issuance of a construction permit or operating license for a civilian nuclear power reactor at that site, unless (i) such issue results from any revision of siting or design criteria by the Commission following such decision; and (ii) the presiding officer determines that such issue substantially affects the design, construction, or operation of the facility or activity for which a license application, authorization, or amendment to expand the spent nuclear fuel storage capacity is being considered.
(d) The provisions of paragraph (c) of this section shall apply only with respect to licenses, authorizations, or amendments to licenses or authorizations applied for under the Atomic Energy Act of 1954, as amended, before December 31, 2005.
(e) Unless the presiding officer disposes of all issues and dismisses the proceeding, appeals from the presiding officer's order disposing of issues and designating one or more issues for resolution in an adjudicatory hearing are interlocutory and must await the end of the proceeding.
In proceedings subject to this subpart, the provisions of subparts A and
(a) The general rules of this subpart govern procedure in any adjudication initiated by a request for a hearing in a proceeding for—
(1) The grant, renewal or licensee-initiated amendment of a materials license subject to parts 30, 32 through 35, 39, 40, or 70 of this chapter, with the exception of a license amendment related to an application to transfer a license; or
(2) The grant, renewal, or licensee-initiated amendment of an operator or senior operator license subject to part 55 of this chapter.
(3) The amendment of a part 50 license following permanent removal of fuel from the part 50 facility to an authorized facility for licensees that have previously made declarations related to permanent cessation of operations and permanent removal of fuel from the reactor in accordance with § 50.82(a)(1). Subpart L hearings for the license termination plan amendment, if conducted, must be completed before license termination.
(b) Any adjudication regarding, (1) a materials license subject to parts 30, 32 through 35, 39, 40, or 70, or an operator or senior operator license subject to part 55 that is initiated by a notice of hearing issued under § 2.104, or (2) a notice of proposed action under § 2.105, or a request for hearing under subpart B of 10 CFR part 2 on an order or a civil penalty, is to be conducted in accordance with the procedures set forth in subpart G of 10 CFR part 2.
(a) The Secretary shall maintain a docket for each adjudication subject to this subpart, commencing with the filing of a request for a hearing. All papers, including any request for a hearing, petition for leave to intervene, correspondence, exhibits, decisions, and orders, submitted or issued in the proceeding; the hearing file compiled in accordance with § 2.1231; and the transcripts of any oral presentations or oral questioning made in accordance with § 2.1235 or in connection with any appeal under this subpart must be filed with the Office of the Secretary and must be included in the docket. The public availability of official records relating to the proceeding is governed by § 2.790.
(b) Documents are filed with the Office of the Secretary in adjudications subject to this subpart either—
(1)(i) By delivery to the Rulemakings and Adjudications Staff of the Office of the Secretary at One White Flint North, 11555 Rockville Pike, Rockville, MD 20852; or
(ii) By mail, telegram or facsimile addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.
(2) Filing by mail, telegram or facsimile is complete as of the time of deposit in the mail, with the telegraph company, or upon facsimile transmission. Filing by other means is complete as of the time of delivery to the Rulemakings and Adjudications Staff of the Office of the Secretary.
(c) Each document submitted for filing in an adjudication subject to this part, other than an exhibit, must be legibly typed, must bear the docket number and the title of the proceeding, and, if it is the first document filed by that participant, must designate the name and address of a person upon whom service can be made. The document also must be signed in accordance with § 2.708(c). A document, other than correspondence, must be filed in an original and two conforming copies. Documents filed by telegram are governed by § 2.708(f). A document that fails to conform to these requirements may be refused acceptance for filing and may be returned with an indication of the reason for nonacceptance.
(d) Computation of time and extension and reduction of time limits is done in accordance with §§ 2.710-2.711.
(e) A request for a hearing or a petition for leave to intervene must be served in accordance with § 2.712 and § 2.1205 (f) and (k). All other documents issued by the presiding officer or the Commission or offered for filing are served in accordance with § 2.712.
(a) Any person whose interest may be affected by a proceeding for the grant, renewal, or licensee-initiated amendment of a license subject to this subpart may file a request for a hearing.
(b) An applicant for a license, a license amendment, or a license renewal who is issued a notice of proposed denial or a notice of denial and who desires a hearing shall file the request for the hearing within the time specified in § 2.103 in all cases. An applicant may include in the request for hearing a request that the presiding officer recommend to the Commission that procedures other than those authorized under this subpart be used in the proceeding, provided that the applicant identifies the special factual circumstances or issues which support the use of other procedures.
(c) For amendments of part 50 licenses under § 2.1201(a)(3), a notice of receipt of the application, with reference to the opportunity for a hearing under the procedures set forth in this subpart, must be published in the
(d) A person, other than an applicant, shall file a request for a hearing within—
(1) Thirty days of the agency's publication in the
(2) If a
(i) Thirty days after the requester receives actual notice of a pending application, or
(ii) Thirty days after the requester receives actual notice of an agency action granting an application in whole or in part, or
(iii) One hundred and eighty days after agency action granting an application in whole or in part.
(e) The request for a hearing filed by a person other than an applicant must describe in detail—
(1) The interest of the requestor in the proceeding;
(2) How the interests may be affected by the results of the proceeding, including the reasons why the requestor should be permitted a hearing, with particular reference to the factors set out in paragraph (h) of this section;
(3) The requestor's areas of concern about the licensing activity that is the subject matter of the proceeding; and
(4) The circumstances establishing that the request for a hearing is timely in accordance with paragraph (d) of this section.
(f) Each request for a hearing must be served, by delivering it personally or by mail to—
(1) The applicant (unless the requestor is the applicant); and
(2) The NRC Staff, by delivery to the General Counsel, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852, or by mail addressed to the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
(g) Within ten (10) days of service of a request for a hearing filed under paragraph (d) of this section, the applicant may file an answer. The NRC staff, if it chooses or if it is ordered to participate as a party under § 2.1213, may file an answer to a request for a hearing within ten (10) days of the designation of the presiding officer.
(h) In ruling on a request for a hearing filed under paragraph (d) of this section, the presiding officer shall determine that the specified areas of concern are germane to the subject matter of the proceeding and that the petition is timely. The presiding officer also shall determine that the requestor meets the judicial standards for standing and shall consider, among other factors—
(1) The nature of the requestor's right under the Act to be made a party to the proceeding;
(2) The nature and extent of the requestor's property, financial, or other interest in the proceeding; and
(3) The possible effect of any order that may be entered in the proceeding upon the requestor's interest.
(i) If a hearing request filed under paragraph (b) of this section is granted, the applicant and the NRC staff shall be parties to the proceeding. If a hearing request filed under paragraph (c) or (d) of this section is granted, the requestor shall be a party to the proceeding along with the applicant and the NRC staff, if the NRC staff chooses or is ordered to participate as a party in accordance with § 2.1213.
(j) If a request for hearing is granted and a notice of the kind described in paragraph (d)(1) previously has not been published in the
(1) The time, place, and nature of the hearing;
(2) The authority under which the hearing is to be held;
(3) The matters of fact and law to be considered;
(4) The time within which any other person whose interest may be affected by the proceeding may petition for leave to intervene, as specified in paragraph (j) of this section; and
(5) The time within which a request to participate under § 2.1211(b) must be filed.
(k) Any petition for leave to intervene must be filed within 30 days of the date of publication of the notice of hearing. The petition must set forth the information required under paragraph (e) of this section.
(1) A petition for leave to intervene must be served upon the applicant. The petition also must be served upon the NRC staff—
(i) By delivery to the General Counsel, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852; or
(ii) By mail addressed to the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
(2) Within ten (10) days of service of a petition for leave to intervene, the applicant and the NRC staff, if the staff chooses or is ordered to participate as a party in accordance with § 2.1213, may file an answer.
(3) Thereafter, the petition for leave to intervene must be ruled upon by the presiding officer, taking into account the matters set forth in paragraph (h) of this section.
(4) If the petition is granted, the petitioner becomes a party to the proceeding.
(l)(1) A request for a hearing or a petition for leave to intervene found by the presiding officer to be untimely under paragraph (d) or (k) of this section will be entertained only upon determination by the Commission or the presiding officer that the requestor or petitioner has established that—
(i) The delay in filing the request for a hearing or the petition for leave to intervene was excusable; and
(ii) The grant of the request for a hearing or the petition for leave to intervene will not result in undue prejudice or undue injury to any other participant in the proceeding, including the applicant and the NRC staff, if the staff chooses or is ordered to participate as a party in accordance with § 2.1213.
(2) If the request for a hearing on the petition for leave to intervene is found to be untimely and the requestor or petitioner fails to establish that it otherwise should be entertained on the paragraph (l)(1) of this section, the request
(m) The filing or granting of a request for a hearing or petition for leave to intervene need not delay NRC staff action regarding an application for a licensing action covered by this subpart.
(n) An order granting a request for a hearing or a petition for leave to intervene may condition or limit participation in the interest of avoiding repetitive factual presentations and argument.
(o) If the presiding officer denies a request for a hearing or a petition for leave to intervene in its entirety, the action is appealable within ten (10) days of service of the order on the question whether the request for a hearing or the petition for leave to intervene should have been granted in whole or in part. If a request for a hearing or a petition for leave to intervene is granted, parties other than the requestor or petitioner may appeal that action within ten (10) days of service of the order on the question whether the request for a hearing or the petition for leave to intervene should have been denied in its entirety. An appeal may be taken by filing and serving upon all parties a statement that succinctly sets out, with supporting argument, the errors alleged. The appeal may be supported or opposed by any party by filing a counter-statement within fifteen (15) days of the service of the appeal brief.
(a) Unless otherwise ordered by the Commission or as provided in paragraph (b) of this section, within ten (10) days of receiving from the Office of the Secretary a request for a hearing relating to a licensing proceeding covered by this subpart, the Chairman of the Atomic Safety and Licensing Board Panel shall issue an order designating a single member of the panel to rule on the request for a hearing and, if necessary, to serve as the presiding officer to conduct the hearing.
(b) For any request for hearing relating to an application under 10 CFR part 70 to receive and store unirradiated fuel at the site of a production or utilization facility that also is the subject of a proceeding under subpart G of this part for the issuance of an operating license, within ten (10) days of receiving from the Office of the Secretary a request for a hearing the Chairman of the Atomic Safety and Licensing Board Panel shall issue an order designating a Licensing Board conducting the operating license proceeding to rule on the request for a hearing and, if necessary, to conduct the hearing in accordance with this subpart. Upon certification to the Commission by the Licensing Board designated to conduct the hearing that the matters presented for adjudication by the parties with respect to the part 70 application are substantially the same as those being heard in the pending proceeding under 10 CFR part 50, the Licensing Board may conduct the hearing in accordance with the procedures in subpart G.
A presiding officer has the duty to conduct a fair and impartial hearing according to law, to take appropriate action to avoid delay, and to maintain order. The presiding officer has all powers necessary to those ends, including the power to—
(a) Regulate the course of the hearing and the conduct of the participants;
(b) Dispose of procedural requests or similar matters;
(c) Hold conferences before or during the hearing for settlement, simplification of the issues, or any other proper purpose;
(d) Certify questions to the Commission for determination, either in the presiding officer's discretion or on direction of the Commission;
(e) Reopen a closed record for the reception of further information at any time prior to initial decision in accordance with § 2.734;
(f) Administer oaths and affirmations;
(g) Issue initial decisions;
(h) Issue subpoenas requiring the attendance and testimony of witnesses at the hearing or the production of documents for the hearing;
(i) Receive written or oral evidence and take official notice of any fact in accordance with § 2.743(i);
(j) Appoint special assistants from the Atomic Safety and Licensing Board Panel in accordance with § 2.722;
(k) Recommend to the Commission that procedures other than those authorized under this subpart be used in a particular proceeding; and
(l) Take any other action consistent with the Act and this chapter.
(a) The presiding officer may permit a person who is not a party to make a limited appearance in order to state his or her views on the issues. Limited appearances may be in writing or oral, at the discretion of the presiding officer, and are governed by rules adopted by the presiding officer. A limited appearance statement is not to be considered part of the decisional record under § 2.1251(c).
(b) Within 30 days of an order granting a request for a hearing under § 2.1205 (b) through (d) or, in instances when it is published, within 30 days of notice of hearing issued under § 2.1205(j), the representative of an interested State, county, municipality, Federally-recognized Indian Tribe, and/or agencies thereof, may request an opportunity to participate in a proceeding under this subpart. The request for an opportunity to participate must state with reasonable specificity the requester's area of concern about the licensing activity that is the subject matter of the proceeding. Upon receipt of a request that is filed in accordance with these time limits and that specifies the requester's areas of concern, the presiding officer shall afford the requester a reasonable opportunity to make written and oral presentations in accordance with §§ 2.1233 and 2.1235, without requiring the representative to take a position with respect to the issues. Participants under this paragraph may notice an appeal of an initial decision in accordance with § 2.1253 with respect to any issue on which they participate.
If a hearing request is filed under § 2.1205(b), the NRC staff shall be a party to the proceeding. If a hearing request is filed under § 2.1205 (c) or (d), within 10 days of the designation of a presiding officer pursuant to § 2.1207, the NRC staff shall notify the presiding officer whether or not the staff desires to participate as a party to the adjudication. In addition, upon a determination by the presiding officer that the resolution of any issue in the proceeding would be aided materially by the staff's participation in the proceeding as a party, the presiding officer may order or permit the NRC staff to participate as a party with respect to that particular issue.
(a) An individual may appear in an adjudication under this subpart on his or her own behalf or by an attorney-at-law. Representation by an attorney-at-law is not necessary in order for an organization or a § 2.1211(b) participant to appear in an adjudication conducted under this subpart. If the representative of an organization is not an attorney-at-law, he or she shall be a member or officer of the organization represented. Upon request of the presiding officer, an individual acting as a representative shall provide appropriate information establishing the basis of his or her authority to act in a representational capacity.
(b) Any action to reprimand, censure, or suspend a party, a § 2.1211(b) participant, or the representative of a party or a § 2.1211(b) participant must be in accordance with the procedures in § 2.713(c).
(a) Within thirty (30) days of the presiding officer's entry of an order granting a request for a hearing, the NRC staff shall file in the docket, present to the presiding officer, and make available to the applicant and any other party to the proceeding a hearing file. Thereafter, within ten (10) days of the date a petition for leave to intervene or a request to participate under § 2.1211(b) is granted, the NRC staff shall make the hearing file available to the petitioner or the § 2.1211(b) participant.
(1) The hearing file must be made available to the applicant and any other party or § 2.1211(b) participant to the proceeding either by—
(i) Service in accordance with § 2.1203(e); or
(ii) Making the file available at the NRC Web site,
(2) The hearing file also must be made available for public inspection and copying at the NRC Web site,
(b) The hearing file will consist of the application and any amendment thereto, any NRC environmental impact statement or assessment relating to the application, and any NRC report and any correspondence between the applicant and the NRC that is relevant to the application. Hearing file documents already available at the NRC Web site,
(c) The NRC staff has a continuing duty to keep the hearing file up to date with respect to the materials set forth in paragraph (b) of this section and to provide those materials for the docket, the presiding officer, and the applicant or any party or § 2.1211(b) participant in a manner consistent with the way the hearing file was made available initially under paragraph (a).
(d) A party or § 2.1211(b) participant may not seek discovery from any other party, § 2.1211(b) participant, or the NRC or its personnel, whether by document production, deposition, interrogatories, or otherwise.
(a) After publication of a notice of hearing in accordance with § 2.1205(i) and after the NRC staff has made the hearing file available in accordance with § 2.1231, the parties and § 2.1211(b) participants shall be afforded the opportunity to submit, under oath or affirmation, written presentations of their arguments and documentary data, informational material, and other supporting written evidence at the time or times and in the sequence the presiding officer establishes by appropriate order. The presiding officer also may, on his or her initiative, submit written questions to the parties to be answered in writing, under oath or affirmation, and supported by appropriate documentary data, informational material, or other written evidence.
(b) In a hearing initiated under § 2.1205(b), the initial written presentation of the applicant that is issued a notice of proposed denial or a notice of denial must describe in detail any deficiency or omission in the agency's denial or proposed denial of its application and what relief is sought with respect to each deficiency or omission.
(c) In a hearing initiated under § 2.1205(d), the initial written presentation of a party that requested a hearing or petitioned for leave to intervene must describe in detail any deficiency or omission in the license application, with references to any particular section or portion of the application considered deficient, give a detailed statement of reasons why any particular sections or portion is deficient or why an omission is material, and describe in detail what relief is sought with respect to each deficiency or omission.
(d) A party or § 2.1211(b) participant making an initial written presentation
(e) Strict rules of evidence do not apply to written submissions under this section, but the presiding officer may, on motion or on the presiding officer's own initiative, strike any portion of a written presentation or a response to a written question that is cumulative, irrelevant, immaterial, or unreliable.
(a) Upon a determination that it is necessary to create an adequate record for decision, in his or her discretion the presiding officer may allow or require oral presentations by any party or § 2.1211(b) participant, including testimony by witnesses. Oral presentations are subject to any appropriate time limits the presiding officer imposes. Responsibility for the conduct of the examination of any witness rests with the presiding officer who may allow a party or § 2.1211(b) participant to propose questions for the presiding officer to pose to a witness.
(b) Oral presentations and responses to oral questioning to be relied upon as oral evidence must be given under oath or affirmation. All oral presentations or oral questioning must be stenographically reported and, except as requested pursuant to section 181 of the Act, must be public unless otherwise ordered by the Commission.
(c) Strict rules of evidence do not apply to oral submissions under this section, but the presiding officer may, on motion or on the presiding officer's own initiative, strike any portion of an oral presentation or a response to oral questioning that is cumulative, irrelevant, immaterial, or unreliable.
(a) Motions presented in the proceeding must be presented and disposed of in accordance with §§ 2.730 (a)-(g).
(b) Unless otherwise ordered by the presiding officer, the applicant or the proponent of an order has the burden of proof.
(a) Except as provided in paragraph (b) of this section, any regulation of the Commission issued in its program for the licensing and regulation of production and utilization facilities, source material, special nuclear material, or byproduct material may not be challenged in any adjudication subject to this subpart.
(b) A party to an adjudication subject to this subpart may petition that the application of a Commission regulation specified in paragraph (a) of this section be waived or an exception made for the particular proceeding. The sole ground for a request for waiver or exception must be that special circumstances exist so that application of the regulation to the subject matter of the proceeding would not serve the purposes for which the regulation was adopted. In the absence of a prima facie showing of special circumstances, the presiding officer may not further consider the matter. If the presiding officer determines that a prima facie showing has been made, he or she shall certify directly to the Commission itself for determination the matter of whether special circumstances support a waiver or an exception and whether a waiver or an exception should be granted. The Commission's determination shall be made after any further proceeding the Commission deems appropriate.
The fair and reasonable settlement of proceedings subject to this subpart is
(a) Unless the Commission directs that the record be certified to it in accordance with paragraph (b) of this section, the presiding officer shall render an initial decision after completion of an informal hearing under this subpart. That initial decision constitutes the final action of the Commission thirty (30) days after the date of issuance, unless any party petitions for Commission review in accordance with § 2.786 or the Commission takes review of the decision sua sponte.
(b) The Commission may direct that the presiding officer certify the record to it without an initial decision and may omit an initial decision and prepare a final decision upon a finding that due and timely execution of its functions so requires.
(c) An initial decision must be in writing and must be based only upon information in the record or facts officially noticed. The record must include all information submitted in the proceeding with respect to which all parties have been given reasonable prior notice and an opportunity to comment. The initial decision must include—
(1) Findings, conclusions, and rulings, with the reasons or basis for them, on all material issues of fact, law, or discretion presented on the record;
(2) The appropriate ruling, order, or denial of relief with its effective date; and
(3) The time within which a petition for review may be filed, the time within which any answer to a petition for review may be filed, and the date when the decision becomes final in the absence of the Commission taking review of the decision.
(d) Matters not put into controversy by the parties may not be examined and decided by the presiding officer. If the presiding officer believes that a serious safety, environmental, or common defense and security matter exists that has not been placed in controversy, the presiding officer shall advise the Commission promptly of the basis for that view, and the Commission may take appropriate action.
(e) Pending review and final decision by the Commission, an initial decision resolving all issues before the presiding officer in favor of authorizing licensing action subject to this subpart is immediately effective upon issuance except—
(1) As provided in any order issued in accordance with § 2.1263 that stays the effectiveness of an initial decision; or
(2) As otherwise provided by the Commission in special circumstances.
(f) Following an initial decision resolving all issues in favor of the licensing action as specified in paragraph (e) of this section, the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, notwithstanding the filing of a petition for review or pendency of any review taken by the Commission pursuant to § 2.786, shall take the appropriate licensing action upon making the appropriate licensing findings promptly, except as may be provided pursuant to paragraph (e)(1) or (2) of this section.
Parties and § 2.1211(b) participants may petition for review of an initial decision under this subpart in accordance with the procedures set out in §§ 2.786 and 2.763 or the Commission may review the decision on its own motion. Commission review will be conducted in accordance with those procedures the Commission deems appropriate. The filing of a petition for review is mandatory for a party to exhaust its administrative remedies before seeking judicial review.
(a) Commission action to render a final decision must be in accordance with § 2.770.
(b) The provisions of § 2.771 govern the filing of petitions for reconsideration.
The Secretary or the Assistant Secretary may rule on procedural matters relating to proceedings conducted by the Commission itself under this subpart to the same extent they can do so under § 2.772 for proceedings under subpart G.
Applications for a stay of any decision or action of the Commission, a presiding officer, or any action by the NRC staff in issuing a license in accordance with § 2.1205(m) are governed by § 2.788, except that any request for a stay of staff licensing action pending completion of an adjudication under this subpart must be filed at the time a request for a hearing or petition to intervene is filed or within 10 days of the staff's action, whichever is later. A request for a stay of a staff licensing action must be filed with the adjudicatory decisionmaker before which the licensing proceeding is pending.
This subpart governs requests for, and procedures for conducting, hearings on any application for the direct or indirect transfer of control of an NRC license which transfer requires prior approval of the NRC under the Commission's regulations, governing statutes, or pursuant to a license condition. This subpart is to provide the only mechanism for requesting hearings on license transfer requests, unless contrary case specific orders are issued by the Commission.
(a) The Commission will notice the receipt of each application for direct or indirect transfer of a specific NRC license by placing a copy of the application at the NRC Web site,
(b) The Commission will also publish in the
(c) Periodic lists of applications received may be obtained upon request addressed to the NRC Public Document Room, US Nuclear Regulatory Commission, Washington, DC 20555-0001.
The Commission will notice the withdrawal of an application by publishing the notice of withdrawal in the same manner as the notice of receipt of the application was published under § 2.1301.
Unless exempt from disclosure under part 9 of this chapter, the following documents pertaining to each application for a license transfer requiring Commission approval will be placed at the NRC Web site,
(a) The license transfer application and any associated requests;
(b) Commission correspondence with the applicant or licensee related to the application;
(c)
(d) The NRC staff Safety Evaluation Report (SER).
(e) Any NRC staff order which acts on the license transfer application; and
(f) If a hearing is held, the hearing record and decision.
The procedures in this subpart will constitute the exclusive basis for hearings on license transfer applications for all NRC specific licenses.
(a) As an alternative to requests for hearings and petitions to intervene, persons may submit written comments regarding license transfer applications. The Commission will consider and, if appropriate, respond to these comments, but these comments do not otherwise constitute part of the decisional record.
(b) These comments should be submitted within 30 days after public notice of receipt of the application and addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.
(c) The Commission will provide the applicant with a copy of the comments. Any response the applicant chooses to make to the comments must be submitted within 10 days of service of the comments on the applicant. Such responses do not constitute part of the decisional record.
(a) Any person whose interest may be affected by the Commission's action on the application may request a hearing or petition for leave to intervene on a license application for approval of a direct or indirect transfer of a specific license.
(b) Hearing requests and intervention petitions must—
(1) State the name, address, and telephone number of the requestor or petitioner;
(2) Set forth the issues sought to be raised and
(i) Demonstrate that such issues are within the scope of the proceeding on the license transfer application,
(ii) Demonstrate that such issues are relevant to the findings the NRC must make to grant the application for license transfer,
(iii) Provide a concise statement of the alleged facts or expert opinions which support the petitioner's position on the issues and on which the petitioner intends to rely at hearing, together with references to the specific sources and documents on which the petitioner intends to rely to support its position on the issues, and
(iv) Provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact;
(3) Specify both the facts pertaining to the petitioner's interest and how the interest may be affected, with particular reference to the factors in § 2.1308(a);
(4) Be served on both the applicant and the NRC Office of the Secretary by any of the methods for service specified in § 2.1313.
(c) Hearing requests and intervention petitions will be considered timely only if filed not later than:
(1) 20 days after notice of receipt is published in the
(2) 45 days after notice of receipt is placed at the NRC Web site,
(3) Such other time as may be provided by the Commission.
(a) Unless otherwise specified by the Commission, an answer to a hearing request or intervention petition may be filed within 10 days after the request or petition has been served.
(b) Unless otherwise specified by the Commission, a reply to an answer may be filed within 5 days after service of that answer.
(c) Answers and replies should address the factors in § 2.1308.
(a) In considering a hearing request or intervention petition on an application for a transfer of an NRC license, the Commission will consider:
(1) The nature of the Petitioner's alleged interest;
(2) Whether that interest will be affected by an approval or denial of the application for transfer;
(3) The possible effect of an order granting the request for license transfer on that interest, including whether the relief requested is within the Commission's authority, and, if so, whether granting the relief requested would redress the alleged injury; and
(4) Whether the issues sought to be litigated are—
(i) Within the scope of the proceeding;
(ii) Relevant to the findings the Commission must make to act on the application for license transfer;
(iii) Appropriate for litigation in the proceeding; and
(iv) Adequately supported by the statements, allegations, and documentation required by § 2.1306(b)(2) (iii) and (iv).
(b) Untimely hearing requests or intervention petitions may be denied unless good cause for failure to file on time is established. In reviewing untimely requests or petitions, the Commission will also consider:
(1) The availability of other means by which the requestor's or petitioner's interest will be protected or represented by other participants in a hearing; and
(2) The extent to which the issues will be broadened or final action on the application delayed.
(c) The Commission will deny a request or petition to the extent it pertains solely to matters outside its jurisdiction.
(d)(1) After consideration of the factors covered by paragraphs (a) through (c) of this section, the Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
(2) Hearings under this subpart will be oral hearings, unless, within 15 days of the service of the notice or order granting a hearing, the parties unanimously agree and file a joint motion requesting a hearing consisting of written comments. No motion to hold a hearing consisting of written comments will be entertained absent unanimous consent of all parties.
(3) A denial of a request for hearing and a denial of any petition to intervene will set forth the reasons for the denial.
(a) A notice of oral hearing will—
(1) State the time, place, and issues to be considered;
(2) Provide names and addresses of participants,
(3) Specify the time limit for participants and others to indicate whether they wish to present views;
(4) Specify the schedule for the filing of written testimony, statements of position, proposed questions for the Presiding Officer to consider, and rebuttal testimony consistent with the schedule provisions of § 2.1321.
(5) Specify that the oral hearing shall commence within 15 days of the date for submittal of rebuttal testimony unless otherwise ordered;
(6) State any other instructions the Commission deems appropriate;
(7) If so determined by the NRC staff or otherwise directed by the Commission, direct that the staff participate as a party with respect to some or all issues.
(b) If the Commission is not the Presiding Officer, the notice of oral hearing will also state:
(1) When the jurisdiction of the Presiding Officer commences and terminates;
(2) The powers of the Presiding Officer;
(3) Instructions to the Presiding Officer to certify promptly the completed hearing record to the Commission without a recommended or preliminary decision.
A notice of hearing consisting of written comments will:
(a) State the issues to be considered;
(b) Provide the names and addresses of participants;
(c) Specify the schedule for the filing of written testimony, statements of position, proposed questions for the Presiding Officer to consider for submission to the other parties, and rebuttal testimony, consistent with the schedule provisions of § 2.1321.
(d) State any other instructions the Commission deems appropriate.
(a) A notice or order granting a hearing or permitting intervention shall—
(1) Restrict irrelevant or duplicative testimony; and
(2) Require common interests to be represented by a single participant.
(b) If a participant's interests do not extend to all the issues in the hearing, the notice or order may limit her/his participation accordingly.
The Secretary or the Assistant Secretary may rule on procedural matters relating to proceedings conducted by the Commission itself under this subpart to the same extent they can do so under § 2.772 for proceedings under subpart G.
(a) Hearing requests, intervention petitions, answers, replies and accompanying documents must be served as described in paragraph (b) of this section by delivery, facsimile transmission, e-mail or other means that will ensure receipt by close of business on the due date for filing. Any participant filing hearing requests, intervention petitions, replies and accompanying documents should include information on mail and delivery addresses, e-mail addresses, and facsimile numbers in their initial filings which may be used by the Commission, Presiding Officer and other parties for serving documents on the participant.
(b) All filings must be served upon the applicant; the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; and participants if any. If service to the Secretary is by delivery or by mail the filings should be addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. E-mail filings may be sent to the Secretary at the following e-mail address: SECY@NRC.GOV. Facsimile transmission filings may be filed with the Secretary using the following number: 301-415-1101.
(c) Service is completed by:
(1) Delivering the paper to the person; or leaving it in her or his office with someone in charge; or, if there is no one in charge, leaving it in a conspicuous place in the office; or, if the recipient has no office or it is closed, leaving it at her or his usual place of residence with some occupant of suitable age and discretion;
(2) Depositing it in the United States mail, properly stamped and addressed; or
(3) Any other manner authorized by law, when service cannot be made as provided in paragraphs (c) (1) or (2) of this section.
(4) For facsimile transmission, sending copies to the facsimile machine of the person being served;
(5) For e-mail, sending the filing in electronic form attached to an e-mail message directed to the person being served.
(d) Proof of service, stating the name and address of the person served and the manner and date of service, shall be shown, and may be made by—
(1) Written acknowledgment of the person served or an authorized representative; or
(2) The certificate or affidavit of the person making the service.
(e) The Commission may make special provisions for service when circumstances warrant.
(a) In computing time, the first day of a designated time period is not included and the last day is included. If the last day is a Saturday, Sunday or legal holiday at the place where the required action is to be accomplished, the time period will end on the next day which is not a Saturday, Sunday or legal holiday.
(b) In time periods of 7 days or less, Saturdays, Sundays and holidays are not counted.
(c) Whenever an action is required within a prescribed period following service of a paper, 3 days shall be added to the prescribed period if service is by regular mail.
(a) Unless otherwise determined by the Commission with regard to a specific application, the Commission has determined that any amendment to the license of a utilization facility or the license of an Independent Spent Fuel Storage Installation which does no more than conform the license to reflect the transfer action, involves respectively, “no significant hazards consideration” or “no generic issue as to whether the health and safety of the public will be significantly affected.”
(b) Where administrative license amendments are necessary to reflect an approved transfer, such amendments will be included in the order that approves the transfer. Any challenge to the administrative license amendment is limited to the question of whether the license amendment accurately reflects the approved transfer.
(a) During the pendency of any hearing under this subpart, consistent with the NRC staff's findings in its Safety Evaluation Report (SER), the staff is expected to promptly issue approval or denial of license transfer requests. Notice of such action shall be promptly transmitted to the Presiding Officer and parties to the proceeding.
(b) Except as otherwise directed in accordance with § 2.1309(a)(7), the NRC staff is not required to be a party to proceedings under this subpart but will offer into evidence its SER associated with the transfer application and provide one or more sponsoring witnesses.
(c) If the NRC staff desires to participate as a party, the staff shall notify the Presiding Officer and the parties and shall thereupon be deemed to be a party with all the rights and responsibilities of a party.
For each hearing, the Secretary will maintain a docket which will include the hearing transcript, exhibits and all papers filed or issued in connection with the hearing. This file will be made available to all parties in accordance with the provisions of § 2.1303 and will constitute the only discovery in proceedings under this subpart.
(a) Each document filed or issued must be clearly legible and bear the docket number, license application number, and hearing title.
(b) Each document shall be filed in one original and signed by the participant or its authorized representative, with the address and date of signature indicated. The signature is a representation that the document is submitted with full authority, the person signing knows its contents and that, to the best of their knowledge, the statements made in it are true.
(c) A document not meeting the requirements of this section may be returned with an explanation for nonacceptance and, if so, will not be docketed.
(a) The Commission will ordinarily be the Presiding Officer at a hearing under this part. However, the Commission may provide in a hearing notice that one or more Commissioners, or any other person permitted by law, will preside.
(b) A participant may submit a written motion for the disqualification of any person presiding. The motion shall be supported by an affidavit setting forth the alleged grounds for disqualification. If the Presiding Officer does not grant the motion or the person does not disqualify himself and the Presiding Officer or such other person is not the Commission or a Commissioner, the Commission will decide the matter.
(c) If any person presiding deems himself or herself disqualified, he or she shall withdraw by notice on the record after notifying the Commission.
(d) If a Presiding Officer becomes unavailable, the Commission will designate a replacement.
(e) Any motion concerning the designation of a replacement Presiding Officer shall be made within 5 days after the designation.
(f) Unless otherwise ordered by the Commission, the jurisdiction of a Presiding Officer other than the Commission commences as designated in the hearing notice and terminates upon certification of the hearing record to the Commission, or when the Presiding Officer is disqualified.
(a) The Presiding Officer in any oral hearing shall conduct a fair hearing, develop a record that will contribute to informed decisionmaking, and, within the framework of the Commission's orders, have the power necessary to achieve these ends, including the power to:
(1) Take action to avoid unnecessary delay and maintain order;
(2) Dispose of procedural requests;
(3) Question participants and witnesses, and entertain suggestions as to questions which may be asked of participants and witnesses.
(4) Order consolidation of participants;
(5) Establish the order of presentation;
(6) Hold conferences before or during the hearing;
(7) Establish time limits;
(8) Limit the number of witnesses; and
(9) Strike or reject duplicative, unreliable, immaterial, or irrelevant presentations.
(b) Where the Commission itself does not preside:
(1) The Presiding Officer may certify questions or refer rulings to the Commission for decision;
(2) Any hearing order may be modified by the Commission; and
(3) The Presiding Officer will certify the completed hearing record to the Commission, which may then issue its decision on the hearing or provide that additional testimony be presented.
Unless otherwise limited by this subpart or by the Commission, participants in a hearing consisting of written comments may submit:
(a) Initial written statements of position and written testimony with supporting affidavits on the issues. These materials shall be filed within 30 days of the date of the Commission's Notice granting a hearing pursuant to § 2.1308(d)(1), unless the Commission or Presiding Officer directs otherwise.
(b) Written responses, rebuttal testimony with supporting affidavits directed to the initial statements and testimony of other participants, and proposed written questions for the Presiding Officer to consider for submittal to persons sponsoring testimony submitted under paragraph (a) of this section. These materials shall to filed within 20 days of the filing of the materials submitted under paragraph (a) of this section, unless the Commission or Presiding Officer directs otherwise. Proposed written questions directed to rebuttal testimony for the Presiding Officer to consider for submittal to persons offering such testimony shall be filed within 7 days of the filing of the rebuttal testimony.
(c) Written concluding statements of position on the issues. These materials shall be filed within 20 days of the filing of the materials submitted under paragraph (b) of this section, unless the Commission or the Presiding Officer directs otherwise.
(a) Unless otherwise limited by this subpart or by the Commission, participants in an oral hearing may submit and sponsor in the hearings:
(1) Initial written statements of position and written testimony with supporting affidavits on the issues. These materials shall be filed within 30 days of the date of the Commission's notice granting a hearing pursuant to § 2.1308(d)(1), unless the Commission or Presiding Officer directs otherwise.
(2)(i) Written responses and rebuttal testimony with supporting affidavits
(ii) Proposed questions for the Presiding Officer to consider for propounding to persons sponsoring testimony.
(3) These materials must be filed within 20 days of the filing of the materials submitted under paragraph (a)(1) of this section, unless the Commission or Presiding Officer directs otherwise.
(4) Proposed questions directed to rebuttal testimony for the Presiding Officer to consider for propounding to persons offering such testimony shall be filed within 7 days of the filing of the rebuttal testimony.
(b) The oral hearing should commence within 65 days of the date of the Commission's notice granting a hearing unless the Commission or Presiding Officer directs otherwise. Ordinarily, questioning in the oral hearing will be conducted by the Presiding Officer, using either the Presiding Officer's questions or questions submitted by the participants or a combination of both.
(c) Written post-hearing statements of position on the issues addressed in the oral hearing may be submitted within 20 days of the close of the oral hearing.
(d) The Commission, on its own motion, or in response to a request from a Presiding Officer other than the Commission, may use additional procedures, such as direct and cross-examination, or may convene a formal hearing under subpart G of this part on specific and substantial disputes of fact, necessary for the Commission's decision, that cannot be resolved with sufficient accuracy except in a formal hearing. The staff will be a party in any such formal hearing. Neither the Commission nor the Presiding Officer will entertain motions from the parties that request such special procedures or formal hearings.
(a) All direct testimony in an oral hearing shall be filed no later than 15 days before the hearing or as otherwise ordered or allowed pursuant to the provisions of § 2.1322.
(b) Written testimony will be received into evidence in exhibit form.
(c) Participants may designate and present their own witnesses to the Presiding Officer.
(d) Testimony for the NRC staff will be presented only by persons designated by the Executive Director for Operations for that purpose.
(e) Participants and witnesses will be questioned orally or in writing and only by the Presiding Officer. Questions may be addressed to individuals or to panels of participants or witnesses.
(f) The Presiding Officer may accept written testimony from a person unable to appear at the hearing, and may request him or her to respond to questions.
(g) No subpoenas will be granted at the request of participants for attendance and testimony of participants or witnesses or the production of evidence.
(a) A participant may appear in a hearing on her or his own behalf or be represented by an authorized representative.
(b) A person appearing shall file a written notice stating her or his name, address and telephone number, and if an authorized representative, the basis of her or his eligibility and the name and address of the participant on whose behalf she or he appears.
(c) A person may be excluded from a hearing for disorderly, dilatory or contemptuous conduct, provided he or she is informed of the grounds and given an opportunity to respond.
(a) Motions and requests shall be addressed to the Presiding Officer, and, if written, also filed with the Secretary and served on other participants.
(b) Other participants may respond to the motion or request. Responses to written motions or requests shall be filed within 5 days after service unless the Commission or Presiding Officer directs otherwise.
(c) The Presiding Officer may entertain motions for extension of time and
(d) When the Commission does not preside, in response to a motion or request, the Presiding Officer may refer a ruling or certify a question to the Commission for decision and notify the participants.
(e) Unless otherwise ordered by the Commission, a motion or request, or the certification of a question or referral of a ruling, shall not stay or extend any aspect of the hearing.
The applicant or the proponent of an order has the burden of proof.
(a) Any application for a stay of the effectiveness of the NRC staff's order on the license transfer application shall be filed with the Commission within 5 days of the issuance of the notice of staff action pursuant to § 2.1316(a).
(b) An application for a stay must be no longer than 10 pages, exclusive of affidavits, and must contain:
(1) A concise summary of the action which is requested to be stayed; and
(2) A concise statement of the grounds for a stay, with reference to the factors specified in paragraph (d) of this section.
(c) Within 10 days after service of an application for a stay under this section, any participant may file an answer supporting or opposing the granting of a stay. Answers must be no longer than 10 pages, exclusive of affidavits, and should concisely address the matters in paragraph (b) of this section, as appropriate. No further replies to answers will be entertained.
(d) In determining whether to grant or deny an application for a stay, the Commission will consider:
(1) Whether the requestor will be irreparably injured unless a stay is granted;
(2) Whether the requestor has made a strong showing that it is likely to prevail on the merits;
(3) Whether the granting of a stay would harm other participants; and
(4) Where the public interest lies.
When a participant fails to act within a specified time, the Presiding Officer may consider that participant in default, issue an appropriate ruling and proceed without further notice to the defaulting participant.
(a) A participant may petition that a Commission rule or regulation be waived with respect to the license transfer application under consideration.
(b) The sole ground for a waiver shall be that, because of special circumstances concerning the subject of the hearing, application of a rule or regulation would not serve the purposes for which it was adopted.
(c) Waiver petitions shall specify why application of the rule or regulation would not serve the purposes for which it was adopted and shall be supported by affidavits to the extent applicable.
(d) Other participants may, within 10 days, file a response to a waiver petition.
(e) When the Commission does not preside, the Presiding Officer will certify the waiver petition to the Commission, which, in response, will grant or deny the waiver or direct any further proceedings.
(a) A reporter designated by the Commission will record an oral hearing and prepare the official hearing transcript.
(b) Except for any portions that must be protected from disclosure in accordance with law and policy as reflected in 10 CFR 2.790, transcripts will be placed at the NRC Web site,
(c) Corrections of the official transcript may be made only as specified by the Secretary.
(a) Upon completion of a hearing, the Commission will issue a written opinion including its decision on the license transfer application and the reasons for the decision.
(b) The decision on issues designated for hearing pursuant to § 2.1308 will be based on the record developed at hearing.
*In the event of any conflict between the provisions of this appendix and any section of this part, the section governs.
Atomic safety and licensing boards are appointed from time to time by the Commission or the Chairman of the Atomic Safety and Licensing Board Panel to conduct hearings in licensing cases under the authority of section 191 of the Act. Section 191 authorizes the Commission to establish one or more atomic safety and licensing boards to conduct public hearings and to make intermediate or final decisions in administrative proceedings relating to granting, suspending, revoking or amending licenses issued by the Commission. It requires that each board consist of one member who is qualified in the conduct of administrative proceedings and two members who have such technical or other qualifications as the Commission deems appropriate to the issues to be decided. Members of each board may be appointed by the Commission or by the Chairman of the Atomic Safety and Licensing Board Panel from a panel selected from private life, the staff of the Commission or other Federal agencies.
An Atomic Safety and Licensing Board may at its discretion appoint special assistants to the Board from the membership of the Atomic Safety and Licensing Board Panel established by the Commission. These special assistants are to be employed to facilitate the hearing process and improve the quality of the record produced for review. The special assistants may serve as technical interrogators in their individual fields of expertise, alternate Atomic Safety and Licensing Board members to sit with the Board and participate in the evidentiary sessions on the issue for which the alternate members were designated, Special Masters to hear evidentiary presentations by the parties on specific technical matters upon the consent of all parties, or informal consultants to brief the board prior to the hearing on the general technical background of subjects involving complex issues. The term “alternate board member” as a “special assistant” within the meaning of 10 CFR 2.722(a)(3) should not be confused with the use of the term “alternate” in 10 CFR 2.721(b). In the latter situation the “alternate” is a substitute for a member of a Board who becomes unavailable. As a special assistant, the “alternate” sits with the three-member Board and not instead of the Board or any of its members.
(a) A public hearing is announced by the issuance of a notice of hearing, published in the
(b) In fixing the time and place of any conference, including prehearing conferences, or of any adjourned session of the evidentiary hearing, due regard shall be had for the convenience and necessity of the parties, petitioners for leave to intervene, or the representatives of such persons, as well as of the Board members, the nature of such conference or adjourned session, and the public interest. Adjourned sessions of hearings may be held in the Washington, DC area if all parties so stipulate. If the parties disagree, and any party considers that there are valid reasons for holding such session in the Washington, DC area, the matter should be referred to the Commission for resolution.
(c)(1) The Commission or the Atomic Safety and Licensing Board may, consider on their own initiative, or a party may request the Commission or the board to consider, a particular issue or issues separately from, and prior to, other issues relating to the effect of the construction and/or operation of the facility upon the public health and safety, the common defense and security, and the environment or in regard to antitrust considerations. If the Commission or the Board determines that a separate hearing should be held, the notice of hearing or other appropriate notice will state the time and place of the separate hearing on such issue or issues. The board designated to conduct the hearing will issue an initial decision, if deemed appropriate, which will be dispositive of the issue(s) considered at the hearing, in the absence of an appeal or Commission review pursuant to § 2.760, before the hearing on, and consideration of, the remaining issues in the proceeding.
(2) In a proceeding relating to the issuance of a construction permit for a facility which is subject to the environmental impact statement requirements of section 102(2)(C) of the National Environmental Policy Act of 1969 and subpart A of part 51 of this chapter and which is a utilization facility for industrial or commercial purposes or is a testing facility, separate hearings may be held and decisions may be issued on National Environmental Policy Act and site suitability issues and other specified issues as provided by subpart F and § 2.761a.
(d) Prior to a hearing, board members should review and become familiar with: The record of any relevant prior proceedings in the case, including initial decisions and Commission orders, the application, the ARCS report, the staff safety evaluation, the applicant's environmental report, the Commission's environmental impact statement, all other papers filed in the proceeding, the Commission's rules of practice, and other regulations or published statements of policy of the Commission as may be pertinent to the proceeding.
(e) At any time when a board is in existence but is not actually in session, the chairman has all the powers of the board to take action on procedural matters. The chairman may have occasion, when the board is not in session, to dispose of preliminary procedural requests including, among other things, motions by parties relating to the conduct of the hearing. He may wish to discuss such requests with the other members of the board before ruling on them. No interlocutory appeal
(a) A special prehearing conference will be held, within ninety (90) days after the notice of hearing has been published, or such other time as the Commission or the Board may deem appropriate, in addition to the standard prehearing conference provided by § 2.752. The special prehearing conference, authorized by § 2.751a, should be used to permit identification of key issues; take steps necessary for further identification of the issues; consider all intervention petitions to allow preliminary or final determination as to the parties; and establish a schedule for further actions in the proceeding.
(b) Within sixty (60) days after discovery has been completed,
(c) A transcript of each prehearing conference will be prepared. The board will issue an order after the conclusion of the special prehearing conference which recites the action taken at the conference and agreements by the parties, identifies the key issues in controversy, makes a preliminary or final determination as to the parties, and provides for submission of status reports on discovery by the parties. The board will also issue an order after the conclusion of the second prehearing conference that specifies the issues in controversy in the proceeding. Each order shall be served upon all parties to the proceeding. Objections to such order may be filed by a party within five (5) days, or, in the case of the staff, within ten (10) days. The board may revise the order in the light of the objections presented and, as permitted by § 2.718(i), may certify for determination to the Commission such matters raised in the objections as it deems appropriate. As specified in § 2.752, the order shall control the subsequent course of the proceeding unless modified for good cause.
(d) Prehearing conferences are open to the public except under exceptional circumstances involving such matters as classified information and certain privileged information not normally a part of the hearing record.
(e) The applicant, the staff and other parties are required to provide each other and the board with copies of prepared testimony in advance of its being offered at the hearing. A schedule may be established at the second prehearing conference for exchange of prepared testimony. Prepared testimony is filed in the Commission's public document room and is available for public inspection. When the staff has reached its conclusions with respect to the application and prepared a safety evaluation, the safety evaluation will be made available—a point of time which may or may not be prior to the hearing.
(a)(1) As required by § 2.714, a person who wishes to intervene must set forth, in a petition for leave to intervene, his interest in the proceeding and how the interest may be affected by Commission action. Petitions for leave to intervene shall, as a basis for enabling the board or the Commission to determine how the petitioner's interest may be affected by the proceeding, set forth (i) the nature of his right under the Act to be made a party to the proceeding, (ii) the nature and extent of the interest that may be affected by the proceeding, and (iii) the effect of any order which may be entered in the proceeding on the petitioner's interest. The petition must identify the specific aspects as to which the petitioner wishes to intervene and set forth with particularity the facts pertaining to his interest. The petitioner must file a supplement to his petition containing his contention(s) and basis therefor not later than fifteen (15) days prior to the holding of the special prehearing conference pursuant to § 2.751a. After consideration of any answers to the petition, the board will rule on the petition. If the board finds that the petitioner's interest is limited to one or more of the issues in the proceeding, the intervenor's participation will be limited to those issues.
Petitions and supplements thereto which set forth contentions relating only to matters outside the jurisdiction of the Commission will be denied. In any event, the granting of a petition for leave to intervene does not operate to enlarge the issues, or become a basis for receipt of evidence, with respect to matters beyond the jurisdiction of the Commission.
(2) Petitions for leave to intervene which are not filed within the time specified in the notice of hearing will not be granted unless the board determines that the petition should be granted based upon paragraph (a)(1) of this section and upon a balancing of (i) good cause, if any, for petitioner's failure to file on time, (ii) the availability of other
(3) Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have all the rights of the applicant to participate fully in the conduct of the hearing, such as the examination and cross-examination of witnesses, with respect to their contentions related to the matters at issue in the proceeding.
(4) If more than one person who has been granted leave to intervene has substantially the same kind of interest that may be affected by the proceeding, and raises the same basic questions, the board or the Commission may order those persons to consolidate their presentation of evidence, cross-examination, briefs, proposed findings of fact and conclusions of law and argument, unless such consolidation cannot be accomplished without prejudice to the rights of a party.
(b) A person who does not wish to, or is not qualified to become a party may be permitted at the discretion of the board, to make a limited appearance pursuant to § 2.715. Persons permitted to make limited appearances do not become parties, but should be permitted to make statements at such stage of the proceeding as the board may consider appropriate. A person making a limited appearance may only make an oral or written statement on the record, and may not participate in the proceeding in any other way. The board may wish to limit the length of oral statements. A member of the public does not have the right to participate unless he has been granted the right to intervene as a party or the right of limited appearance for the purpose of making a statement.
(a) Once the key issues in controversy are identified in the special prehearing conference order (§ 2.751a.(d)), discovery may proceed and will be limited to those matters. In no event should the parties be permitted to use discovery procedures to conduct a “fishing expedition” or to delay the proceeding.
(b) Under the Commission's rules of practice, discovery permitted by §§ 2.720, 2.740, 2.740a, 2.740b, 2.741, 2.742, and 2.744 must be completed by the second prehearing conference, except upon leave for good case shown.
(c) Depositions, interrogatories and document production between parties other than the staff are obtainable on notice or request to the other party and without leave of the Commission or the board, in line with the Federal Rules of Civil Procedure.
(d) In general, staff documents that are relevant to a proceeding will be publicly available as a matter of course unless there is a compelling justification for their nondisclosure. Therefore, document discovery directed at the staff will be restricted, as provided in § 2.744, since most staff documents will be publicly available and should reasonably disclose the basis for the staff's position. Formal discovery of documents against the staff will be limited to cases where it concerns a matter necessary to a proper decision in a case and the information sought is not obtainable elsewhere. Discovery as a legitimate means of obtaining information will not be inhibited, but in view of the comprehensive body of information routinely available without request, there should be minimum need to resort to time consuming discovery procedures. Discovery against the staff (and other NRC personnel, including consultants) by way of deposition is permitted upon a showing of exceptional circumstances. Interrogatories may be addressed to the staff where the information is necessary to proper decision in the case and not obtainable elsewhere.
The board should use its powers under §§ 2.718 and 2.757 to assure that the hearing is focused upon the matters in controversy among the parties and that the hearing process for the resolution of controverted matters is conducted as expeditiously as possible, consistent with the development of an adequate decisional record.
The following procedures should be observed in the conduct of public hearings:
(a) Preliminary:
(1) A verbatim transcript will be made of the hearing.
(2) The Chairman should convene the hearing by stating the title of the proceeding and describing its nature.
(3) He should state the date, time, and place at which the prehearing conferences were held, and identify the persons participating in them. He should summarize the second prehearing conference order.
(4) He should explain the procedures for the conduct of the hearing. He should request that counsel for the parties identify themselves on the record, and provide them with the opportunity to make opening statements of their respective positions.
(5) He should describe, for the benefit of members of the public who may be present, the respective roles of the board, the ACRS and the staff, and the Commission procedures for review of the decision. He should
(b)(1) The Chairman should call attention to the provisions of § 2.715 for participation by limited appearance. He should briefly explain these provisions and the rights of persons who are permitted to make limited appearances.
(2) The Chairman should inquire of those in attendance whether there are any who wish to participate in the hearing by limited appearance.
(3) Should any person seek leave to intervene when the hearing has been convened, he must set forth, with particularity in a written petition, the reasons why it was not possible to file a petition within the time prescribed in the notice of hearing, as described in section III, to afford a basis for the board to determine whether or not good cause has been shown for the untimely filing. In granting a petition for leave to intervene which is not timely filed, the board will impose such conditions as are appropriate to minimize any delay in the proceeding.
(4) A person making a limited appearance may want not only to state his position, but to raise questions which he would like to have answered. This should be permitted to the extent the questions are within the scope of the proceeding as defined by the issues set out in the notice of hearing, the prehearing conference order, and any later orders. Usually such persons should be asked to make their statements and raise their questions early in the proceeding so that the board will have an opportunity to be sure that relevant and meritorious questions are properly dealt with during the course of the hearing.
(5) It is the Commission's view that the rules governing intervention and limited appearances are necessary in the interest of orderly proceedings. The Commission also believes that through these two methods of public participation all members of the public are assured of the right to participate by a method appropriate to their interest in the matter. This should be fully explained at the beginning of the hearing. In some cases the board may feel that it must deny an application to intervene but that it can still accommodate the desire of the person involved by allowing him to make a statement and raise questions under the limited appearance rule.
(6) Boards have considerable discretion as to the manner in which they accommodate their conduct of the hearing to local public interest and the desires of local citizens to be heard. Particularly in cases where it is evident that there is local concern as to the safety of the proposed plant, boards should so conduct the hearing as to give appropriate opportunity for local citizens to express their views, while at the same time protecting the legal interests of all parties and the public interest in an orderly and efficient licensing process.
(7) In some cases, argument and further hearing can add nothing to the filings of the parties. In those cases the board is authorized, pursuant to § 2.749, on motion, to render a decision, if the filings in the proceeding and other materials show that there is no genuine issue as to any material fact. However, in proceedings involving construction permits, this procedure may be used only for determining subordinate issues and not the ultimate issue as to whether the construction permit should be issued.
(c) Opening statements:
(1) It is anticipated that the applicant, who has the burden of proof, will, at an appropriate time early in the proceeding, make an oral statement describing in terms that will be readily understood by the public, the principal safety and environmental considerations involved in carrying out the activity sought to be authorized.
(2) Other parties to the proceeding may also make an oral opening statement describing their position on the proposed licensing action.
(d) Evidence:
(1) Pursuant to § 2.732, the applicant has the burden of proof.
(2) The parties are required to submit direct testimony in written form and serve copies of such prepared written testimony on all parties pursuant to the schedule established at the second prehearing conference—in any event, at least 15 days in advance of the session of the hearing at which such testimony is to be presented, as provided by § 2.743(b), unless the board orders otherwise on the basis of objections presented. The staff's position is reflected primarily in the safety evaluation and final environmental impact statement. Consequently, the staff will not present its case until these documents are available. The use of such advance written testimony is expected to expedite the hearing process.
(3) The testimony of all witnesses will be given under oath. These witnesses may be collectively sworn at the opening of the hearing or if additional witnesses are called upon to testify at a subsequent stage they may be sworn at the time of their appearance. There is ordinarily no need for oral recital of prepared testimony unless the Board considers that some useful purpose will be served.
(4) The proceedings should be conducted as expeditiously as practicable, without impairing the development of a clear and adequate record. The order of presenting testimony may be freely varied in the conduct of the hearing. The Board may find it helpful to take expert testimony from witnesses on a roundtable basis after the receipt in evidence of prepared testimony.
(5) To prevent unnecessary delays and an unnecessarily large record, the Board may, pursuant to § 2.757, limit cumulative testimony, strike argumentative, repetitious, cumulative, or irrelevant evidence, take other necessary and proper steps to prevent argumentative, repetitious or cumulative cross examination, and impose appropriate time limitations on arguments.
(6) Documentary evidence may be offered in evidence as provided in § 2.743. Such evidence offered during the course of the hearing should be described by counsel, and furnished to the reporter for marking. Documents offered for marking should be numbered in order of receipt. On identification of a document, it may be offered in evidence.
(7) Objections may be made by counsel to any questions or any line of questioning, and to the admission of any document and should be ruled upon by the board. The board may admit the evidence, may sustain the objection, or may receive the evidence, reserving for later determination the question of admissibility. In passing on objections, the board, while not bound to view proferred evidence according to its admissibility under strict application of the rules of evidence in judicial proceedings, should exclude evidence that is irrelevant to issues in the case as defined in the notice of hearing or the prehearing conference order, or that pertains to matters outside the jurisdiction of the board or the Nuclear Regulatory Commission. Irrelevant material in prepared testimony submitted in advance under § 2.743(b) may be subject to a motion to strike under the procedures provided in § 2.730.
(8) Use of scientifically or technically trained persons who are not attorneys to conduct direct or cross-examination on behalf of a party is provided for in § 2.733. This procedure is a privilege, not a right, and may be granted to further the conduct of the hearing. Before permitting such a person to conduct examination of witnesses, the board must determine (i) that he has technical or scientific qualifications, (ii) that he has read the written testimony and any documents which are to be the subject of his examination, and (iii) that he has prepared himself to conduct a meaningful and expeditious examination. Permission to conduct examination will be limited to the areas in which the interrogator is shown to be qualified. The party on whose behalf the interrogator conducts the examination and his attorney are responsible for the interrogator's conduct of examination or cross-examination.
(9) The extent to which challenges to NRC regulations can be made in a licensing proceeding is limited. A party may petition for waiver of or exception to the application of a specified NRC rule or regulation to an aspect of the subject matter of the proceeding. The party must file a petition and an affidavit that identifies the specific aspect of the subject matter of the proceeding as to which application of the rule or regulation would not serve the purpose for which the regulation was adopted and that sets forth with particularity the special circumstances alleged to justify a waiver or exception on that ground (§ 2.758). Upon a finding by the board, based on the petition and affidavits and any material submitted by other parties, that the party has not made a prima facie case, no evidence, discovery, or argument will be allowed on the matter. If the Board finds that such a showing has been made, it will certify the matter, without ruling, directly to the Commission for a determination as to whether the application of the regulation to a particular aspect of the subject matter of the proceeding should be waived or an exception made.
(10) The Commission has recognized the public interest in achieving fair and reasonable settlement of contested proceedings (§ 2.759). Therefore, to the extent not inconsistent with the Act, fair and reasonable settlements are encouraged, either as to particular issues in a proceeding or the entire proceeding.
(11) Unless testimony is being taken on a roundtable basis or there is some occasion for clarification of testimony as rendered, the board may wish to reserve its questions until the parties have completed questioning of the witnesses, since counsel for the respective parties will generally be prepared to develop the various lines of pertinent questions.
(12) Conferences for the clarification of matters between the board and the parties, or the formulation of more meaningful questions, may be used to expedite the hearing and simplify the record. Informal conferences, including telephone conferences, should be encouraged to this end.
(13) The board should ordinarily not adjourn the hearing once it has begun, except as the hearing may be divided into segments to permit consideration of discrete areas, such as (i) radiological health and safety or (ii) environmental impact. To the extent practicable, legal questions should be resolved prior to the hearing. If the board believes that additional information is required in the presentation of the case, it would be expected to request the applicant or other party to supplement the presentation. If a recess should prove necessary to obtain such additional evidence, the recess should ordinarily be postponed until available evidence has been received.
(14) Many of the time limitations prescribed in part 2 were set to allow the maximum time for the parties to the proceedings to perform various activities. Where the activities covered by the limitations can be performed in less time, the time limits may
(e) Record:
(1) The transcript of testimony and the exhibits, together with all of the papers and requests filed in a proceeding, constitute the record for decision, except to the extent that official notice is taken.
(2) Generally speaking, a decision by a board must be made on the basis of evidence which is in the record of the proceeding. A board, however, is expected to use its expert knowledge and experience in evaluating and drawing conclusions from the evidence that is in the record. The board may also take account of and rely on certain facts which do not have to be “proved” since they are “officially noticed”; these facts do not have to be “proved” since they are matters of common knowledge. Pursuant to § 2.743(i) “official notice” may be taken of any fact of which judicial notice might be taken by the courts of the United States and of any technical or scientific fact within the knowledge of the Commission as an expert body. Each fact officially noticed must be specified in the record with sufficient particularity to advise the parties of the matters which have been noticed or brought to the attention of the parties before the final decision, and each party adversely affected by the decision must be afforded an opportunity to controvert the noticed fact. (For example, a board might take “official notice” of the fact that high level wastes are encountered mainly as liquid residue from fuel reprocessing plants.) Matters which are “officially noticed” by a board furnish the same basis for findings of fact as matters which have been placed in evidence and proved in the usual sense.
(f) Participation by board members:
(1) In contested proceedings, the board will determine controverted matters as well as decide whether the findings required by the Act and the Commission's regulations should be made and whether, in accordance with subpart A of part 51, the construction permit should be issued as proposed. Thus, in such proceedings, the board will determine the matters in controversy and may be called upon to make technical judgments of its own on those matters. As to matters pertaining to radiological health and safety which are not in controversy, boards are neither required nor expected to duplicate the review already performed by the staff and ACRS, and they are authorized to rely upon the testimony of the staff, the applicant, and the conclusions of the ACRS, which are not controverted by any party.
(2) In an uncontested case, boards are neither required nor expected to duplicate the radiological safety review already performed by the staff and the ACRS and they are authorized to rely upon the testimony of the staff and the applicant, and the conclusions of the ACRS. The role of the board is not to conduct a de novo evaluation of the application, but rather to decide whether the application and the record of the proceeding contain sufficient information, and the review of the application by the Commission's staff, including the environmental review pursuant to the National Environmental Policy Act of 1969, has been adequate, to support the findings proposed to be made by the Director of Regulation and the issuance of the construction permit proposed by the Director of Regulation. In doing so, the board is expected to be mindful of the fact that it is the applicant, not the staff, who is the proponent of the construction permit and who has the burden of proof.
(3) Whether the construction permit proceeding is contested or uncontested, the board will, as to environmental impact matters, (a) determine whether the requirements of section 102(2) (A), (C) and (E) of the National Environmental Policy Act of 1969 and subpart A of part 51 of this chapter have been complied with; (b) independently consider the final balance among conflicting factors contained in the record, with a view to determining the appropriate action to be taken; and (c) determine whether the construction permit should be granted, denied, or appropriately conditioned to protect environmental values.
(4) A question may be certified to the Commission for determination when a major or novel question of policy, law or procedure is involved which cannot be resolved except by the Commission and when the prompt and final decision of the question is important for the protection of the public interest or to avoid undue delay or serious prejudice to the interests of a party. For example, a board may find it appropriate to certify novel questions as to the regulatory jurisdiction of the Commission or the right of persons to intervene.
(g) Close of hearing:
(1) If, at the close of the hearing, the board should have uncertainties with respect to the matters in controversy because of a need for a clearer understanding of the evidence which has already been presented, it is expected that the board would normally invite further argument from the parties—oral or written or both—before issuing its initial decision. If the uncertainties arise from lack of sufficient information in the record, it is expected that the board would normally require further evidence to be submitted in writing with opportunity for the other parties to reply or reopen the hearing for the taking of further evidence, as appropriate. If either of such courses is followed, it is expected that the applicant would normally be
(2) A board should give each party the opportunity to make a brief closing statement.
(3) A schedule should be set by the board and recorded, either in the transcript or by written order, of the dates upon which the parties are directed by the board to file proposed findings of fact and conclusions of law. In uncontested cases, the proposed findings will ordinarily be extremely brief. In contested proceedings, proposed findings of fact and conclusions of law submitted by the parties may be more detailed. While brevity in such submissions is encouraged, the proposed findings and conclusions should be such as to reflect the position of parties submitting them, and the technical and factual basis therefor.
(4) The board should dispose of any additional procedural requests.
(5) The chairman should formally close the hearing.
(a) A board, acting through the Chairman, should dispose of procedural requests made after the close of the hearing, including motions of the parties for correction of the transcript. Responses to requests and motions of the parties are made part of the record by issuance of written orders.
(b) On receipt of proposed findings and conclusions from the parties, the board should prepare the initial decision. Under the Administrative Procedure Act and the Commission's regulations, the decision should include:
(1) Findings, conclusions, and rulings, with the reasons or basis for them, on all material issues of fact, law, or discretion presented on the record;
(2) All facts officially noticed and relied on, if any, in making the decision;
(3) The appropriate ruling, order, or denial or relief, with the effective date and time within which a notice of appeal from the initial decision may be filed;
(4) The time when the decision becomes final.
(c) Issues to be decided by the board:
(1) In a contested proceedings for the issuance of a construction permit, the board will determine the following issues:
(i) Whether in accordance with the provisions of § 50.35(a) of this chapter:
(
(
(
(
(
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(ii) Whether the applicant is technically qualified to design and construct the proposed facility;
(iii) Whether the applicant is financially qualified to design and construct the proposed facility;
(iv) Whether the issuance of a permit for the construction of the facility will be inimical to the common defense and security or to the health and safety of the public;
(v) Whether, with respect to the requirements of section 102(2) (A), (C) and (E) of the National Environmental Policy Act, in accordance with subpart A of part 51 of this chapter, the construction permit should be issued as proposed.
(2) In an uncontested proceeding for the issuance of a construction permit, the board will, without conducting a de novo evaluation of the application, determine:
(i) Whether the application and the record of the proceeding contain sufficient information, and the review of the application by the Commission's staff has been adequate, to support the findings proposed to be made and required by the Act for the issuance of the construction permit proposed by the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, and
(ii) Whether the review conducted pursuant to the National Environmental Policy Act of 1969 has been adequate.
(3) Regardless of whether the proceeding is contested or uncontested, the board will, in its initial decision, in accordance with subpart A of part 51 of this chapter:
(i) Determine whether the requirements of section 102(2) (A), (C) and (E) of the National Environmental Policy Act and subpart A of part 51 of this chapter have been complied with in the proceeding;
(ii) Independently consider the final balance among conflicting factors contained in the record of the proceeding with a view to
(iii) Determine whether the construction permit should be issued, denied, or appropriately conditioned to protect environmental values.
(d) It is expected that ordinarily a board will render its initial decision within 35 days after its receipt of proposed findings of fact and conclusions of law filed by the parties in a contested case and within 15 days after receipt of such proposed findings and conclusions in an uncontested case.
(e) The initial decision will be transmitted to the Chief, Docketing and Service Section, Office of the Secretary, for issuance.
(f) After the board's initial decision is issued, the entire record of the hearing, including the board's initial decision, will be sent to the Commission for review. In the course of this review, the Commission may allow the board's decision to become the final decision of the Commission, may modify a board decision, or may send the case back to the board for additional testimony on particular points or for further consideration of particular issues.
(a) Two members, being a majority of the board, constitute a quorum, if one of those members is the member qualified in the conduct of administrative proceedings. The vote of a majority controls in any decision by a board, including rulings during the course of a hearing as well as formal orders and the initial decision. A dissenting member is of course, free to express his dissent and the reasons for it in a separate opinion for the record.
(b) The Commission or the Chairman of the Atomic Safety and Licensing Board Panel may designate a technically qualified alternate or an alternate qualified in the conduct of administrative proceedings, or both, for a board. The designation of an alternate is discretionary. Alternates may be designated where the Commission (or the Chairman of the Atomic Safety and Licensing Board Panel) in its judgment believes that a proceeding involves factors that warrant the continuing assignment and presence of an alternate. If any alternates are designated before the hearing, they will receive copies and become familiar with the application and other documents filed by the parties prior to the start of the hearing. It is expected that an alternate will be constituted or appointed by the Commission or the Chairman of the Atomic Safety and Licensing Board Panel as a member of the board in situations where a technically qualified member of the board, or the member qualified in the conduct of administrative proceedings, becomes unavailable.
(c) Section 2.781 specifies when consultation between Commissioners or boards, on the one hand, and the staff, on the other hand, is permitted in licensing proceedings conducted under subpart G. Section 2.781 also permits a board, in the same type of proceeding, to consult with members of the panel from which the members of the board are drawn.
(a) This section sets out certain differences in procedure from those described in sections I-VII above, which are required by the fact that the proceeding is for the issuance of an operating license rather than a construction permit. Otherwise, the provisions of sections I through VII of this statement of general policy also apply to an operating license proceeding, except as the context requires otherwise.
(b) In an operating license proceeding the board will determine the matters in controversy among the parties, and where the board determines that a serious safety, environmental, or common defense and security matter was not raised by the parties, the board will determine such matter as being among the issues to be decided. Those issues will be specified in the notice of a hearing issued by the Commission, or in a prehearing conference order issued by the board in the exercise of its discretion during the hearing.
The issues will be the matters in controversy among the parties or raised by the board within the purview of the following:
(1) Whether there is reasonable assurance that construction of the facility will be substantially completed, on a timely basis, in conformity with the construction permit and the application as amended, the provisions of the Act, and the rules and regulations of the Commission;
(2) Whether the facility will operate in conformity with the application as amended, the provisions of the Act, and the rules and regulations of the Commission;
(3) Whether there is reasonable assurance (i) that the activities to be authorized by the operating license can be conducted without endangering the health and safety of the public, and (ii) that such activities will be conducted in compliance with the Commission's regulations;
(4) Whether the applicant is technically and financially qualified to engage in the activities to be authorized by the operating license in accordance with the Commission's regulations, except that the issue of financial qualification shall not be considered by the board if the applicant is an electric utility seeking a license to operate a utilization facility of the type described in § 50.21(b) or § 50.22.
(5) Whether the applicable provisions of 10 CFR part 140 have been satisfied;
(6) Whether issuance of the license will be inimical to the common defense and security or to the health and safety of the public; and
(7) Whether, with respect to the requirements of section 102(2) (A), (C), and (E) of the National Environmental Policy Act, in accordance with subpart A of part 51, the operating license should be issued as proposed.
(c) The board, in operating license proceedings, will make findings on the matters in controversy among the parties and any matter not raised by the parties but examined by the board in its discretion in accordance with paragraph (b) of this section and § 2.760a. Depending on the resolution of those matters, the Director of Regulation would issue, deny, or appropriately condition the operating license.
(d) In operating license proceedings, the procedure for summary disposition of the proceeding on the pleadings described in § 2.749 may be used to determine the ultimate issue of whether the operating license should be issued.
(a) Under the Atomic Energy Act of 1954, as amended, the Commission is required, with respect to applications for construction permits or operating licenses for production and utilization facilities for industrial or commercial purposes licensed under section 103, which include power reactors subject to the mandatory hearing requirements of section 189a of the Act, to follow procedures for antitrust review in section 105c of the Act. This section outlines the procedures used by the Commission to implement that section.
(b)(1) When the antitrust information portion of an application is received and docketed for a facility construction permit under section 103 of the Act which is subject to antitrust review under section 105c, the notice of receipt of the antitrust information published in the
(2) Upon receipt of the antitrust information responsive to Regulatory Guide 9.3 submitted in connection with an application for a facility operating license under section 103 of the Act, the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, shall publish in the
(3) If the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, after reviewing any comments or information received in response to the published notice and any comments or information regarding the applicant received from the Attorney General, concludes that there have been no significant changes since the completion of the previous antitrust review in connection with the construction permit, a finding of no significant changes shall be published in the
(4) If, as a result of the reevaluation of the finding described above, it is determined that there have been no significant changes, the Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, shall deny the request and shall publish a notice of finding of no significant changes in the
(5) If the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, concludes that significant changes have occurred since the completion of the previous
(c)(1) Except as provided in paragraph (c)(2) below, the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, shall refer and transmit a copy of each application for a construction permit or an operating license for a utilization or production facility under section 103 of the Act, to the Attorney General as required by section 105c of the Act. Under that section, the Attorney General will, within a reasonable time, but in no event to exceed 180 days after receipt, render such advice to the Commission as is determined to be appropriate in regard to the finding to be made by the Commission as to whether the activities under the license would create or maintain a situation inconsistent with the antitrust laws specified in subsection 105a of the Act.
(2) The review by the Attorney General described in paragraph (c)(1) above is not required for applications for operating licenses for production or utilization facilities under section 103 of the Act for which the construction permit was also issued under section 103, unless the Director of Nuclear Reactor Regulation or the Director of Nuclear Material Safety and Safeguards, as appropriate, determines, after consultation with the Attorney General and in accordance with § 2.101(e), that such review is advisable on the ground that significant changes in the licensee's activities or proposed activities have occurred subsequent to the previous review by the Attorney General and by the Commission under section 105c of the Act in connection with the construction permit.
(d) The Director of Nuclear Reactor Regulation or Director of Nuclear Material Safety and Safeguards, as appropriate, will publish the Attorney General's advice in the
(e) If a hearing on antitrust aspects of the application is requested, or is recommended by the Attorney General, it will generally be held separately from the hearing held on matters of radiological health and safety and common defense and security described in sections I-VIII of this appendix. The notice of hearing will fix a time for the hearing, which will be as soon as practicable after the receipt of the Attorney General's advice and compliance with section 189a of the Act and other provisions of this part. However, as permitted by subsection 105c(8) of the Act, with respect to proceedings in which an application for a construction permit was filed prior to December 19, 1970, and proceedings in which a written request for antitrust review of an application for an operating license to be issued under section 104b has been made by a person who intervened or sought by timely written notice to the Commission to intervene in the construction permit proceeding for the facility to obtain a determination of antitrust consideration or to advance a jurisdictional basis for such determination within 25 days after the date of publication in the
(f) Hearings on antitrust aspects will be conducted by a presiding officer, either an Administrative Law Judge or an atomic safety and licensing board comprised of three members, one of whom will be qualified in the conduct of administrative proceedings and two of whom will have such technical or other qualifications as the Commission deems appropriate to the issues to be decided.
(g) When the Attorney General has advised that there may be adverse antitrust aspects and recommends that a hearing be held, the Attorney General or his designee may participate as a party in the proceedings.
(h) At the hearing, the presiding officer will give due consideration to the advice received from the Attorney General and to evidence pertaining to antitrust aspects received at the hearing.
(i) The presiding officer will, in the initial decision, make a finding as to whether the activities under the proposed license would create or maintain a situation inconsistent with the antitrust laws as specified in section 105a of the Act. If the presiding officer finds that such a situation would be created or maintained, it will consider, in determining whether the permit or license should be issued or continued, such other factors as it deems necessary to protect the public interest, including the need for power in the affected area. The certainty of contravening
(j) On the basis of the findings in the proceeding on the antitrust aspect of the application, the presiding officer may (i) authorize the issuance of the permit or license after favorable consideration of matters of radiological health and safety and common defense and security, and matters raised under the National Environmental Policy Act of 1969, at the hearing described in sections I-VIII of this appendix; (ii) authorize the continuation of a permit or license already issued; (iii) direct the denial of the application for the permit or license, or the rescission of a permit or license already issued; or (iv) authorize the issuance of a permit or license subject to appropriate conditions, and subject to favorable consideration of matters of radiological health and safety and common defense matters raised under the National Environmental Policy Act of 1969 at the hearing described in sections I-VIII of this appendix.
For
Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 274, 73 Stat. 688, as amended (42 U.S.C. 2021); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
Subpart A also issued under secs. 602-605, Pub. L. 88-352, 78 Stat. 252, 253 (42 U.S.C. 2000d-1-2000d-4); sec. 401, 88 Stat. 1254 (42 U.S.C. 5891).
Subpart B also issued under sec. 504, Pub. L. 93-112, 87 Stat. 394 (29 U.S.C. 706); sec. 119, Pub. L. 95-602, 92 Stat. 2984 (29 U.S.C. 794); sec. 122, Pub. L. 95-602, 92 Stat. 2984 (29 U.S.C. 706(6)).
Subpart C also issued under Title III of Pub. L. 94-135, 89 Stat. 728, as amended (42 U.S.C. 6101).
Subpart E also issued under 29 U.S.C. 794.
The regulations in this part implement:
(a) The provisions of title VI of the Civil Rights Act of 1964, Pub. L. 88-352; (78 Stat. 241; 42 U.S.C. 2000a note), and title IV of the Energy Reorganization Act of 1974, Pub. L. 93-438, (88 Stat. 1233; 42 U.S.C. 5801 note), which relate to nondiscrimination with respect to race, color, national origin or sex in any program or activity receiving Federal financial assistance from NRC;
(b) The provisions of section 504 of the Rehabilitation Act of 1973, as amended, Pub. L. 93-112 (87 Stat. 355; 29 U.S.C. 701 note), Pub. L. 95-602 (92 Stat. 2955; 29 U.S.C. 701 note), which relates
(c) The provisions of the Age Discrimination Act of 1975, as amended Pub. L. 94-135 (89 Stat. 713; 42 U.S.C. 3001 note), Pub. L. 95-478 (92 Stat. 1513; 42 U.S.C. 3001 note), which relates to nondiscrimination on the basis of age in any program or activity receiving Federal financial assistance.
Subpart A sets forth rules applicable to title VI of the Civil Rights Act of 1964 and title IV of the Energy Reorganization Act of 1974. (The Acts are collectively referred to in subpart A as “the Act”.) Subpart B sets forth rules applicable specifically to matters pertaining to section 504 of the Rehabilitation Act of 1973, as amended. Subpart C sets forth rules pertaining to the provisions of the Age Discrimination Act of 1975, as amended, Pub. L. 94-135 (89 Stat. 713; 42 U.S.C. 3001 note), Pub. L. 95-478 (92 Stat. 1513; 42 U.S.C. 3001 note), which relates to nondiscrimination on the basis of age in any program or activity receiving Federal financial assistance.
This part applies to any program for which Federal financial assistance is authorized under a law administered by NRC. The programs to which this part applies are listed in appendix A of this part; appendix A may be revised from time to time by notice published in the
(a) Contracts of insurance or guaranty; or
(b) Procurement contracts; or
(c) Employment practices under any program or activity except as provided in §§ 4.13, 4.122 and 4.302.
(a)
(b)
(c)
(d)
(1) Funds;
(2) Services of Federal personnel or other personnel at Federal expense; or
(3) Real and personal property or any interest in or use of property, including—
(i) Transfers or leases of property for less than fair market value or for reduced consideration;
(ii) Proceeds from a subsequent transfer or lease of property if the Federal share of its fair market value is not returned to the Federal Government; and the
(iii) Sale and lease of, and the permission to use (other than on casual or transient basis) Federal property or any interest in such property without consideration or at a nominal consideration, or at a consideration which is reduced for the purpose of assisting the
(e)
(f)
(g)
(h)
(i)
(j)
Except as otherwise indicated, all communications and reports relating to this part should be addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Communications and reports may be delivered in person to the Commission's offices at 11555 Rockville Pike, Rockville, Maryland 20852-2738.
Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0053.
(b) The approved information collection requirements contained in this part appear in §§ 4.32, 4.34, 4.125, 4.127, 4.231, 4.232, 4.322, and 4.324.
No person in the United States shall, on the ground of sex, race, color, or national origin, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any program to which this subpart applies.
(a) A recipient under any program to which this subpart applies may not, directly or through contractual or other arrangements, on the ground of sex, race, color, or national origin:
(1) Deny an individual any service, financial aid, or other benefit provided under the program;
(2) Provide any service, financial aid, or other benefit to an individual which is different, or is provided in a different manner, from that provided to others under the program;
(3) Subject an individual to segregation or separate treatment in any matter related to his receipt of any service, financial aid, or other benefit under the program;
(4) Restrict an individual in any way in the enjoyment of any advantage or privilege enjoyed by others receiving any service, financial aid, or other benefit under the program;
(5) Treat an individual differently from others in determining whether he satisfies any admission, enrollment, quota, eligibilty, membership or other requirement or condition which individuals must meet in order to be provided any service, financial aid, or other benefit provided under the program;
(6) Deny an individual an opportunity to participate in the program through the provision of services or otherwise or afford him an opportunity to do so which is different from that afforded others under the program (including the opportunity to participate in the program as an employee but only to the extent set forth in § 4.13).
(b) A recipient in determining the types of services, financial aid, or other benefits, or facilities which will be provided under any such program, or the class of individuals to whom, or the situations in which, such services, financial aid, other benefits, or facilities will be provided under any such program, or the class of individuals to be afforded an opportunity to participate in any such program, may not, directly or through contractual or other arrangements, utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination because of their sex, race, color, or national origin, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program as respects individuals of a particular sex, race, color, or national origin.
(c) In determining the site or location of facilities, a recipient or applicant may not make selections with the purpose or effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any program to which this subpart applies, on the grounds of sex, race, color, or national origin; or with
(d) As used in this section the services, financial aid, or other benefits provided under a program receiving Federal financial assistance shall be deemed to include any services, financial aid, or other benefit provided in or through a facility provided with the aid of Federal financial assistance.
(e) The enumeration of specific forms of prohibited discrimination in this section and § 4.13 does not limit the generality of the prohibition in § 4.11.
(f) This subpart does not prohibit the consideration of sex, race, color, or national origin if the purpose and effect are to remove or overcome the consequences of practices or impediments which have restricted the availability of, or participation in, the program or activity receiving Federal financial assistance, on the grounds of sex, race, color or national origin. Where previous discriminatory practice or usage tends, on the grounds of sex, race, color, or national origin, to exclude individuals from participation in, to deny them the benefits of, or to subject them to discrimination under any program or activity to which this subpart applies, the applicant or recipient has an obligation to take reasonable action to remove or overcome the consequences of the prior discriminatory practice or usage, and to accomplish the purposes of the Act.
(a) Where a primary objective of a program of Federal financial assistance to which this subpart applies is to provide employment, a recipient may not, directly or through contractual or other arrangements, subject an individual to discrimination on the ground of sex, race, color, or national origin in its employment practices under such program (including recruitment or recruitment advertising, employment, layoff or termination, upgrading, demotion, or transfer, rates of pay or other forms of compensation, and use of facilities), including programs where a primary objective of the Federal financial assistance is (1) to assist such individuals through employment to meet expenses incident to the commencement or continuation of their education or training, or (2) to provide work experience which contributes to the education or training of such individuals. (Examples of such programs are nuclear training equipment grants, grants and loans of materials for training, and fellowship programs.) The requirements applicable to construction employment under any such program shall be those specified in or pursuant to part III of Executive Order 11246 or any Executive order which supersedes it.
(b) Where a primary objective of the Federal financial assistance is not to provide employment, but discrimination on the grounds of sex, race, color, or national origin in the employment practices of the recipient or other persons subject to this subpart tends, on the grounds of sex, race, color, or national origin, to exclude individuals from participation in, to deny them the benefits of, or to subject them to discrimination under any program to which this subpart applies, the provisions of paragraph (a) of this section shall apply to the employment practices of the recipient or other persons subject to this subpart to the extent necessary to assure equality of opportunity to, and nondiscriminatory treatment of, beneficiaries.
A recipient shall not be deemed to have failed to comply with § 4.11 if immediate provision of a service or other benefit to an individual is necessary to prevent his death or serious impairment of his health, and such service or other benefit cannot be provided except by or through a medical institution which refuses or fails to comply with § 4.11.
(a) Every grant, loan or contract under a program to which this subpart applies, except a program to which § 4.22 applies, shall, as a condition to its
(b) In the case of real property, structures or improvements thereon, or interests therein, which was acquired with Federal financial assistance, or in the case where Federal financial assistance is provided in the form of a transfer of real property or interest therein from the Federal Government, the instrument effecting or recording the transfer shall contain a covenant running with the land assuring nondiscrimination for the period during which the real property is used for a purpose for which the Federal financial assistance is extended or for another purpose involving the provision of similar services or benefits. Where no transfer of property is involved, but property is improved with Federal financial assistance, the recipient shall agree to include such a covenant in any subsequent transfer of such property. Where the property is obtained from the Federal Government, such convenant may also include a condition coupled with a right to be reserved by the NRC to revert title to the property in the event of a breach of the covenant where, in the discretion of the NRC, such a condition and right of reverter is appropriate to the program and to the nature of the grant and the grantee. In such event if a transferee of real property proposes to mortgage or otherwise encumber the real property as security for financing construction of new, or improvement of existing, facilities on such property for the purposes for which the property was transferred, the NRC may agree, upon request of the transferee and if necessary to accomplish such financing, and upon such conditions as the NRC deems appropriate, to forbear the exercise of such right to revert title for so long as the lien of such mortgage or other encumbrance remains effective.
(c) Transfers of surplus property are subject to regulations issued by the Administrator of General Services (41 CFR 101-6.2).
Every application by a State or a State agency for continuing Federal financial assistance shall require the submission of and every grant, loan, or contract to or with a State or a State agency to carry out a program involving continuing Federal financial assistance to which this subpart applies, shall, as a condition to its approval and the extension of any Federal financial assistance pursuant to the grant, loan or contract, contain or be accompanied by, a statement that the program is (or, in the case of a new program, will be) conducted in compliance with all requirements imposed by or pursuant to this subpart, and shall provide or be accompanied by provisions for such methods of administration for the program as are found by the responsible NRC official to give reasonable assurance that the recipient and all other recipients of Federal financial assistance under such program will comply
(a) In the case of a grant, loan or contract involving Federal financial assistance to an institution of higher education, the assurance required by § 4.21 shall extend to admission practices and to all other practices relating to the treatment of students.
(b) The assurance required with respect to an institution of higher education, hospital, or any other institution, insofar as the assurance relates to the institution's practices with respect to admission or other treatment of individuals as students, patients, or clients of the institution or to the opportunity to participate in the provision of services or other benefits to such individuals, shall be applicable to the entire institution unless the institution establishes, to the satisfaction of the responsible NRC official, that the institution's practices in designated parts or programs of the institution will in no way affect its practices in the program of the institution for which Federal financial assistance is sought, of the beneficiaries of or participants in such program. If in any such case the assistance sought is for the construction of a facility or part of a facility, the assurance shall in any event extend to the entire facility and to facilities operated in connection therewith.
The responsible NRC official shall to the fullest extent practicable seek the cooperation of recipients in obtaining compliance with this subpart and shall provide assistance and guidance to recipients to help them comply voluntarily with this subpart.
(a) Each recipient shall keep records and submit to the responsible NRC official, timely, complete, and accurate compliance reports at the times and in the form and containing the information that the responsible NRC official may determine to be necessary to enable the official to ascertain whether the recipient has complied or is complying with this subpart.
(b) In the case of any program under which a primary recipient extends Federal financial assistance to any other recipient, the other recipient shall also submit necessary compliance reports to the primary recipient to enable the primary recipient to carry out its obligations under this subpart.
(c) The primary recipient shall retain each record of information needed to complete a compliance report pursuant to paragraph (a) of this section for three years or as long as the primary recipient retains the status of primary recipient as defined in § 4.4, whichever is shorter.
Each recipient shall permit access by the responsible NRC official during normal business hours to such of its books, records, accounts, and other sources of information, and its facilities as may be pertinent to ascertain compliance with this subpart. Where any information required of a recipient is in the exclusive possession of any other agency, institution or person and that agency, institution or person shall fail or refuse to furnish this information, the recipient shall so certify in its report and shall set forth what efforts it has made to obtain the information.
Each recipient shall make available to participants, beneficiaries, and other interested persons such information regarding the provisions of this subpart and its applicability to the program under which the recipient receives Federal financial assistance, and make such information available to them in such manner, as the responsible NRC official finds necessary to apprise such persons of the protections against discrimination assured them by the Act and this subpart.
The responsible NRC official shall from time to time review the practices
Any person who believes himself or any specific class of individuals to be subjected to discrimination prohibited by this subpart may by himself or by a representative file with the responsible NRC official a written complaint. A complaint must be filed not later than ninety (90) days from the date of the alleged discrimination, unless the time for filing is extended by the responsible NRC official. A complaint shall be signed by the complainant or his representative.
The responsible NRC official will make a prompt investigation whenever a compliance review, report, complaint, or any other information indicates a possible failure to comply with this subpart. The investigation should include, where appropriate, a review of the pertinent practices and policies of the recipient, the circumstances under which the possible noncompliance with this subpart occurred, and other factors relevant to a determination as to whether the recipient has failed to comply with this subpart.
(a) If an investigation pursuant to § 4.43 indicates a failure to comply with this subpart, the responsible NRC official will so inform the recipient and the matter will be resolved by voluntary means whenever possible. If it has been determined that the matter cannot be resolved by voluntary means, action will be taken as provided for in §§ 4.46 through 4.49.
(b) If an investigation does not warrant action pursuant to paragraph (a) of this section, the responsible NRC official will so inform the recipient and the complainant, if any, in writing.
No recipient or other person shall intimidate, threaten, coerce, or discriminate against any individual for the purpose of interfering with any right or privilege secured by the Act or this subpart, or because he has made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing under this subpart. The identity of complainants shall be kept confidential, except to the extent necessary to carry out the purposes of this subpart including the conduct of any investigation, hearing, or judicial proceeding arising thereunder.
If there appears to be a failure or threatened failure to comply with any of the provisions of this subpart, and if the noncompliance or threatened concompliance cannot be corrected by informal means, compliance with this subpart may be effected by the suspension or termination of or refusal to grant or to continue Federal financial assistance or by any other means authorized by law. Such other means may include, but are not limited to: (a) A reference to the Department of Justice with a recommendation that appropriate proceedings be brought to enforce any rights of the United States under any law of the United States (including other titles of the Act), or any assurance or other contractual undertaking, and (b) any applicable proceeding under State or local law.
If an applicant fails or refuses to furnish an assurance required under § 4.21 or otherwise fails or refuses to comply with a requirement imposed by or pursuant to that section, Federal financial assistance may be refused in accordance with the procedures of § 4.48.
No order suspending, terminating, or refusing to grant or continue Federal financial assistance shall become effective until: (a) The responsible NRC official has advised the applicant or recipient of his failure to comply and has determined that compliance cannot be secured by voluntary means, (b) there
No action to effect compliance by any other means authorized by law shall be taken until: (a) The responsible NRC official has determined that compliance cannot be secured by voluntary means, (b) the recipient or other person has been notified of its failure to comply and of the action to be taken to effect compliance, and (c) the expiration of at least ten (10) days from the mailing of such notice to the recipient or other person. During this period of at least ten (10) days, additional efforts shall be made to persuade the recipient or other person to comply with this subpart and to take such corrective action as may be appropriate.
(a) Whenever an opportunity for hearing is required by § 4.48, the responsible NRC official shall serve on the applicant or recipient, by registered or certified mail, return receipt requested, a notice of opportunity for hearing which will:
(1) Inform the applicant or recipient of his right within twenty (20) days of the date of the notice of opportunity for hearing, or such other period as may be specified in the notice, to request a hearing;
(2) Set forth the alleged item or items of noncompliance with this subpart;
(3) Specify the issues;
(4) State that compliance with this subpart may be effected by an order providing for the termination of or refusal to grant or to continue assistance, as appropriate, under the program involved; and
(5) Provide that the applicant or recipient may file a written answer to the notice of opportunity for hearing under oath or affirmation within twenty (20) days of its date, or such other period as may be specified in the notice.
(b) The applicant or recipient may respond to a notice of opportunity for hearing by filing a written answer under oath or affirmation. The answer shall specifically admit or deny each allegation, or, where the applicant or recipient does not have knowledge or information sufficient to form a belief, the answer may so state and the statements shall have the effect of a denial. Allegations of fact not denied shall be deemed to be admitted. The answer shall separately state and identify matters alleged as affirmative defenses and may also set forth the matters of fact and law on which the applicant or recipient relies. The answer may request a hearing.
(c) If the answer requests a hearing, the Commission will issue a notice of hearing specifying:
(1) The time, place, and nature thereof;
(2) The legal authority and jurisdiction under which the hearing is to be held; and
(3) The matters of fact and law asserted or to be considered. The time and place of hearing will be fixed with due regard for the convenience and necessity of the parties or their representatives and for the public interest. An answer to a notice of hearing is not required.
(d) An applicant or recipient may file an answer, and waive or fail to request
(e) An answer or stipulation may consent to the entry of an order in substantially the form set forth in the notice of opportunity for hearing; such order may be entered by the responsible Commission official. The consent of the applicant or recipient to the entry of an order shall constitute a waiver by him of a right to: (1) A hearing under the Act and § 4.48, (2) findings of fact and conclusions of law, and (3) seek Commission review.
(f) The failure of an applicant or recipient to file an answer within the period prescribed, or, if he requests a hearing, his failure to appear therefor, shall constitute a waiver by him of a right to: (1) A hearing under the Act and § 4.48, (2) conclusions of law, and (3) seek Commission review. In the event of such waiver, the responsible NRC official may find the facts on the basis of the record available and enter an order in substantially the form set forth in the notice of opportunity for hearing.
(g) An order entered in accordance with paragraph (e) or (f) of this section shall constitute the final decision of the Commission, unless the Commission, on its own motion, within forty-five (45) days after entry of the order, issues its own decision, which shall then constitute the final decision of the Commission.
(h) A copy of an order entered by the responsible NRC official shall be mailed to the applicant or recipient and to the complainant, if any.
(i) Nothing in this section shall be deemed to place the burden of proof on the applicant or recipient.
One or more members of the Commission or one or more administrative law judges appointed pursuant to section 3105 of title 5 of the United States Code shall: (a) Preside at a hearing and (b) make findings of fact and conclusions of law if an applicant or recipient waives a hearing and submits written information or argument for the record in accordance with § 4.51(d).
In all proceedings under §§ 4.51-4.81, the applicant or recipient and the responsible NRC official shall have the right to be represented by counsel. A notice of appearance shall be filed by counsel prior to participation in any such proceedings.
(a) The hearing, decision, and any administrative review thereof shall be conducted in conformity with 5 U.S.C. 554-557 (sections 5-8 of the Administrative Procedure Act), and in accordance with such procedures as are proper (and not inconsistent with §§ 4.61 through 4.64) relating to the conduct of the hearing, giving of notices subsequent to those provided for in § 4.51, taking of testimony, exhibits, arguments and briefs, requests for finding, and other related matters. Both the responsible NRC official and the applicant or recipient shall be entitled to introduce all relevant evidence on the issues as stated in the notice of hearing or as determined by the presiding officer at the outset of or during the hearing.
(b) Technical rules of evidence shall not apply to hearings conducted pursuant to this subpart, but rules or principles designed to assure production of the most credible evidence available and to subject testimony to test by cross-examination shall be applied where reasonably necessary by the presiding officer. The presiding officer may exclude irrelevant, immaterial, or unduly repetitious evidence. All documents and other evidence offered or taken for the record shall be open to examination by the parties and opportunity shall be given to refute facts and arguments advanced on either side of the issues. A transcript shall be made of the oral evidence except to the extent the substance thereof is stipulated for the record.
(c) Each decision made after a hearing has been held shall be based on the hearing record, and written findings of fact and conclusions of law shall be made.
(d) If an applicant or recipient waives a hearing and submits written information or argument for the record in accordance with § 4.51(d), written findings of fact and conclusions of law shall be made.
In cases in which the same or related facts are asserted to constitute noncompliance with this subpart with respect to two or more programs to which this subpart applies or noncompliance with this subpart and the regulations of one or more other Federal departments or agencies issued under title VI of the Civil Rights Act of 1964, the Commission may, by agreement with such other departments or agencies, where applicable, provide for the conduct of consolidated or joint hearings, and for the application to such hearings of rules of procedure not inconsistent with this subpart. Final decisions in such cases, insofar as programs subject to this subpart are concerned shall be made in accordance with § 4.72.
The officer designated:
(a) To preside at a hearing, or,
(b) To make findings of fact and conclusions of law if an applicant or recipient waives a hearing and submits written information or argument for the record in accordance with § 4.51(d), shall render an initial decision on the record, or, if the Commission so directs, shall certify the entire record to the Commission for decision, together with a recommended decision on the record. A copy of such initial decision, or of such certification and recommended decision, shall be mailed to the applicant or recipient.
(a) The applicant or recipient, within thirty (30) days of the mailing of an initial decision or a recommended decision, may file with the Commission his exceptions to such decision, with his reasons therefor.
(b) In the absence of exceptions to an initial decision, the Commission may, on its own motion within forty-five (45) days after the mailing of such initial decision, serve on the applicant or recipient a notice that the Commission will review the decision.
(c) Upon the filing of exceptions to an initial decision or of a notice of review, the Commission shall review such initial decision and issue its own decision on the record with its reasons therefor.
(d) In the absence of either exceptions to an initial decision or of a notice of review, such initial decision shall constitute the final decision of the Commission.
(e) Upon the filing of exceptions to a recommended decision, the Commission shall review such recommended decision and issue its own decision on the record with its reasons therefor.
(f) In the absence of exceptions to a recommended decision, the Commission shall review such recommended decision and issue its own decision on the record with its reasons therefor.
Each decision of a presiding officer or the Commission shall set forth the rulings on each finding, conclusion, or exception presented, and shall identify the requirement or requirements imposed by or pursuant to this subpart with which it is found that the applicant or recipient has failed to comply.
The final decision may provide for suspension or termination of, or refusal to grant or continue Federal financial assistance, in whole or in part, under the program involved, and may contain such terms, conditions, and other provisions as are consistent with and will effectuate the purposes of the Act and this subpart, including provisions designed to assure that no Federal financial assistance will thereafter be extended under such program to the applicant or recipient determined by such
(a) An applicant or recipient adversely affected by an order issued under § 4.74 shall be restored to full eligibility to receive Federal financial assistance if it satisfies the terms and conditions of that order for such eligibility or if it brings itself into compliance with this subpart and provides reasonable assurance that it will fully comply with this subpart.
(b) Any applicant or recipient adversely affected by an order entered pursuant to § 4.74 may at any time request the responsible NRC official to restore fully its eligibility to receive Federal financial assistance. Any such request shall be supported by information showing that the applicant or recipient has met the requirements of paragraph (a) of this section. If the responsible NRC official determines that those requirements have been satisfied, he shall restore such eligibility.
(c) If the responsible NRC official denies any such request, the applicant or recipient may submit a request for a hearing in writing, specifying why it believes such official to have been in error. It shall thereupon be given an expeditious hearing, with the decision on the record, in accordance with rules of procedure issued by the responsible NRC official. The applicant or recipient will be restored to such eligibility if it proves at such a hearing that it satisfied the requirements of paragraph (a) of this section. While proceedings under this section are pending, the sanctions imposed by the order issued under § 4.74 shall remain in effect.
Action taken pursuant to section 602 of the Civil Rights Act of 1964 is subject to judicial review as provided in section 603 of that Act.
All regulations, orders, or like directions heretofore issued by any officer of the NRC which impose requirements designed to prohibit any discrimination against individuals on the grounds of sex, race, color, or national origin under any program to which this subpart applies, and which authorize the suspension or termination of or refusal to grant or to continue Federal financial assistance to any applicant for or recipient of such assistance under such program for failure to comply with such requirements, are hereby superseded to the extent that such discrimination is prohibited by this subpart, except that nothing in this subpart shall be deemed to relieve any person of any obligation assumed or imposed under any such superseded regulation, order, instruction, or like direction prior to the effective date of this subpart. Nothing in this subpart, however, shall be deemed to supersede any of the following (including future amendments thereof):
(a) Executive Orders 10925, 11114, and 11246 and regulations issued thereunder, or
(b) Executive Order 11063 and regulations issued thereunder and any other regulations or instructions insofar as such order, regulations or instructions prohibit discrimination on the grounds of sex, race, color, or national origin in any program or situation to which this subpart is inapplicable, or prohibit discrimination on any other ground.
The responsible NRC official shall issue and promptly make available to interested persons forms and detailed instructions and procedures for effectuating this subpart as applied to programs to which this subpart applies and for which he is responsible.
The Commission may from time to time assign to officials of other departments or agencies of the Government, with the consent of the department or agency involved, responsibilities in connection with the effectuation of the purposes of title VI of the Civil Rights Act of 1964 and this subpart, other than responsibility for final decision as provided in § 4.72, including the achievement of effective coordination and maximum uniformity within the NRC and within the Executive Branch of the Government in the application of title VI of the Civil Rights Act and this subpart to similar programs and in similar situations. Any action taken, determination made, or requirement imposed by an official of another department or agency acting pursuant to an assignment of responsibility under this section shall have the same effect as though such action had been taken by the responsible NRC official.
As used in this subpart:
(a)
(b) As used in paragraph (a) of this section, the phrase:
(1)
(2)
(3)
(4)
(i) Has a physical or mental impairment that does not substantially limit major life activities but is treated by a recipient as constituting such a limitation;
(ii) Has a physical or mental impairment that substantially limits major life activities only as a result of the attitudes of others toward such impairment; or
(iii) Does not have a physical or mental impairment but is treated by a recipient as having such an impairment.
(c)
(d)
(a) No qualified handicapped person, shall, on the basis of handicap, be excluded from participation in, be denied the benefits of, or otherwise be subject to discrimination under any program or activity that receives or benefits from Federal financial assistance.
(b)(1) A recipient, in providing any aid, benefit, or service, may not, directly or through contractual, licensing, or other arrangements, on the basis of handicap:
(i) Deny a qualified handicapped person the opportunity to participate in or benefit from the aid, benefit, or service;
(ii) Afford a qualified handicapped person an opportunity to participate in or benefit from the aid, benefit, or service that is not equal to that afforded others;
(iii) Provide a qualified handicapped person with an aid, benefit, or service that is not as effective in affording equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement as that provided to others;
(iv) Provide different or separate aid, benefits, or services to handicapped persons or to any class of handicapped persons than is provided to others unless such action is necessary to provide qualified handicapped persons with aid, benefits, or services that are as effective as those provided to others;
(v) Aid or perpetuate discrimination against a qualified handicapped person by providing significant assistance to any agency, organization, or person that discriminates on the basis of handicap in providing any aid, benefit, or service to beneficiaries of the recipient's program;
(vi) Deny a qualified handicapped person the opportunity to participate as a member of planning or advisory boards; or
(vii) Otherwise limit a qualified handicapped person in the enjoyment of any right, privilege, advantage, or opportunity enjoyed by others receiving the aid, benefit, or service.
(2) A recipient may not deny a qualified handicapped person the opportunity to participate in programs or activities that are not separate or different, despite the existence of permissibly separate or different programs or activities.
(3) A recipient may not directly or through contractual or other arrangements, utilize criteria or methods of administration: (i) That have the effect of subjecting qualified handicapped persons to discrimination on the basis of handicap, (ii) that have the purpose or effect of defeating or substantially impairing accomplishment of the objectives of the recipient's program with respect to handicapped persons, or (iii) that perpetuate the discrimination of another recipient if both recipients are subject to common administrative control or are agencies of the same State.
(4) A recipient may not, in determining the site or location of a facility, make selections: (i) That have the effect of excluding handicapped persons from, denying them the benefits of, or otherwise subjecting them to discrimination under any program or activity that receives or benefits from Federal financial assistance or (ii) that have the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the program or activity with respect to handicapped persons.
(c) The exclusion of nonhandicapped persons from the benefits of a program limited by Federal statute or Executive Order to handicapped persons or the exclusion of a specific class of handicapped persons from a program limited by Federal statute or Executive Order to a different class of handicapped persons is not prohibited by this subpart.
(d) Recipients shall administer programs and activities in the most integrated setting appropriate to the needs of qualified handicapped persons.
(e) Recipients shall take appropriate steps to ensure that communications with their applicants, employees, and beneficiaries are available to persons with impaired vision and hearing.
(a) No qualified handicapped person shall, on the basis of handicap, be subjected to discrimination in employment under any program or activity that receives or benefits from Federal financial assistance.
(b) A recipient shall make all decisions concerning employment under any program or activity to which this subpart applies in a manner which ensures that discrimination on the basis of handicap does not occur and may not limit, segregate, or classify applicants or employees in any way that adversely affects their opportunities or status because of handicap.
(c) The prohibition against discrimination in employment applies to the following activities:
(1) Recruitment, advertising, and the processing of applications for employment;
(2) Hiring, upgrading, promotion, award of tenure, demotion, transfer, layoff, termination, right of return from layoff, and rehiring;
(3) Rates of pay or any other form of compensation and changes in compensation;
(4) Job assignments, job classifications, organizational structures, position descriptions, lines of progression, and seniority lists;
(5) Leaves of absence, sick leave, or any other leave;
(6) Fringe benefits available by virtue of employment, whether or not administered by the recipient;
(7) Selection and financial support for training, including apprenticeship, professional meetings, conferences, and other related activities and selection for leaves of absence to pursue training;
(8) Employer sponsored activities, including social or recreational programs; and
(9) Any other term, condition, or privilege of employment.
(d) A recipient may not participate in a contractual or other relationship that has the effect of subjecting qualified handicapped applicants or employees to discrimination prohibited by this subpart. The relationships referred to in this paragraph include relationships with employment and referral agencies, with labor unions, with organizations providing or administering fringe benefits to employees of the recipient, and with organizations providing training and apprenticeship programs.
(a) A recipient shall make reasonable accommodation to the known physical or mental limitations of an otherwise qualified handicapped applicant or employee unless the recipient can demonstrate that the accommodation would impose an undue hardship on the operation of its program.
(b) Reasonable accommodation may include: (1) Making facilities used by employees readily accessible to and usable by handicapped persons, and (2) job restructuring, part-time or modified work schedules, acquisition or modification of equipment or devices, the provision of readers or interpreters, and other similar actions. This list is neither all-inclusive nor meant to suggest that an employer must follow all the actions listed.
(c) In determining pursuant to paragraph (a) of this section whether an accommodation would impose an undue hardship on the operation of a recipient's program, factors to be considered include:
(1) The overall size of the recipient's program with respect to number of employees, number and type of facilities, and size of budget;
(2) The type of the recipient's operations, including the composition and structure of the recipient's workforce; and
(3) The nature and cost of the accommodation needed.
(d) A recipient may not deny any employment opportunity to a qualified handicapped employee or applicant if the basis for denial is the need to make reasonable accommodation to the
(a) A recipient may not make use of any employment test or other selection criterion that screens out or tends to screen out handicapped persons or any class of handicapped persons unless:
(1) The test score or other selection criterion as used by the recipient is shown to be job-related for the position in question; and
(2) Alternative job-related tests or criteria that do not screen out or tend to screen out as many handicapped persons are not available.
(b) A recipient shall select and administer tests concerning employment so as best to ensure that, when administered to an applicant or employee who has a handicap that impairs sensory, manual, or speaking skills, the test results accurately reflect the applicant's or employee's job skills, aptitude, or whatever other factor the test purports to measure, rather than reflecting the applicant's or employee's impaired sensory, manual, or speaking skills (except where those skills are the factors that the test purports to measure).
(a) Except as provided in paragraphs (b) and (c) of this section, a recipient may not conduct a preemployment medical examination or may not make preemployment inquiry of an applicant as to whether the applicant is a handicapped person or as to the nature of severity of a handicap. A recipient may, however, make preemployment inquiry into an applicant's ability to perform job-related functions.
(b) When a recipient is taking remedial action to correct the effects of past discrimination, or when a recipient is taking voluntary action to overcome the effects of conditions that resulted in limited participation in its federally assisted program or activity, or when a recipient is taking affirmative action pursuant to section 503 of the Rehabilitation Act of 1973, the recipient may invite applicants for employment to indicate whether and to what extent they are handicapped:
(1) The recipient makes clear to the applicant that the information requested is intended for use solely in connection with its remedial action obligations or its voluntary or affirmative action efforts; and
(2) The recipient makes clear to the applicant that the information is being requested on a voluntary basis, that it will be kept confidential as provided in paragraph (d) of this section, that refusal to provide it will not subject the applicant to any adverse treatment, and that it will be used only in accordance with this subpart.
(c) Nothing in this section shall prohibit a recipient from conditioning an offer of employment on the results of a medical examination conducted prior to the employee's entrance on duty:
(1) All entering employees are subjected to such an examination regardless of handicap; and
(2) The results of such an examination are used only in accordance with the requirements of this subpart.
(d) Information obtained in accordance with this section as to the medical condition or history of the applicant must be collected on separate forms. The recipient shall retain each form as a record for three years from the date the applicant's employment ends, or, if not hired, from the date of application. Each form must be accorded confidentiality as a medical record, except that:
(1) Supervisors and managers may be informed regarding restrictions on the work or duties that may be assigned to handicapped persons and regarding necessary accommodations;
(2) First aid and safety personnel may be informed, where appropriate, if the condition associated with the handicap might require emergency treatment; and
(3) Government officials investigating compliance with the Rehabilitation Act of 1973 shall be provided relevant information upon request.
No qualified handicapped person shall, because a recipient's facilities
(a)
(b)
(c)
(d)
(1) Identify physical obstacles in the recipient's facilities that limit the accessibility and usability of its program or activity to handicapped persons;
(2) Describe in detail the methods that will be used to make the facilities accessible to and usable by handicapped persons;
(3) Specify the schedule for taking the steps necessary to achieve full program accessibility and, if the time period or the transition plan is longer than 1 year, identify steps that will be taken during each year of the transition period; and
(4) Indicate the person responsible for implementation of the plan.
(e)
(a)
(b)
(2) For purposes of this section, section 4.1.6(1)(g) of UFAS shall be interpreted to exempt from the requirements of UFAS only mechanical rooms and other spaces that, because of their intended use, will not require accessibility to the public or beneficiaries or result in the employment or residence therein of persons with physical handicaps.
(3) This section does not require recipients to make building alterations that have little likelihood of being accomplished without removing or altering a load-bearing structural member.
(a)
(b)
(c)
(2) Where a recipient is found to have discriminated against persons on the basis of handicap in violation of section 504 or this subpart and where another recipient exercises control over the recipient that has discriminated, the responsible NRC official, where appropriate, may require either or both recipients to take remedial action.
(3) The responsible NRC official may, where necessary to overcome the effects of discrimination in violation of section 504 or this subpart, require a recipient to take remedial action: (i) With respect to handicapped persons who are no longer participants in the recipient's program but who were participants in the program when such discrimination occurred or (ii) with respect to handicapped persons who would have been participants in the program had the discrimination not occurred.
(d)
(e)
(i) Evaluate, with the assistance of interested persons, including handicapped persons or organizations representing handicapped persons, its current policies and practices and the effects thereof that do not or may not meet the requirements of this subpart;
(ii) Modify, after consultation with interested persons, including handicapped persons or organizations representing handicapped persons, any policies and practices that do not meet the requirements of this subpart; and
(iii) Take, after consultation with interested persons, including handicapped persons or organizations representing handicapped persons, appropriate remedial steps to eliminate the effects of any discrimination that resulted from adherence to those policies and practices.
(2) A recipient shall, for at least three years following completion of the evaluation required under paragraph (e)(1) of this section, maintain on file, make available for public inspection, and provide to the responsible NRC official upon request: (i) A list of the interested persons consulted, (ii) a description of areas examined and any problems identified, and (iii) a description of any modifications made and of any remedial steps taken.
(f)
(a) A recipient shall take appropriate initial and continuing steps to notify participants, beneficiaries, applicants, and employees, including those with impaired vision or hearing, and unions or professional organizations holding collective bargaining or professional agreements with the recipient that it does not discriminate on the basis of handicap in violation of section 504 and this subpart. The notification shall state, where appropriate, that the recipient does not discriminate in admission or access to, or treatment or employment in, its programs and activities. The notification shall also include an identification of the responsible employee designated pursuant to § 4.231(f). A present recipient shall make the initial notification required by this paragraph within 90 days of the effective date of this subpart. Methods of initial and continuing notification may include the posting of notices, publication in newspapers and magazines, placement of notices in recipients’ publications, and distribution of memoranda or other written communications.
(b) If a recipient publishes or uses recruitment materials or publications containing general information that it makes available to participants, beneficiaries, applicants, or employees, if shall include in those materials or publications a statement of the policy described in paragraph (a) of this section. A recipient may meet the requirement of this paragraph either by including appropriate inserts in existing materials and publications or by revising and reprinting the materials and publications.
The enforcement and hearing procedures set forth in §§ 4.41 through 4.75 of subpart A with respect to discrimination based on sex, race, color or national origin shall be used for the enforcement of the regulations in subpart B with respect to discrimination based on handicap.
The purpose of this subpart is to set forth NRC policies and procedures under the Age Discrimination Act of 1975 which prohibits discrimination on the basis of age in programs or activities receiving Federal financial assistance.
(a) The Age Discrimination Act of 1975 and these regulations apply to any program or activity receiving Federal financial assistance from NRC.
(b) The Age Discrimination Act of 1975 and these regulations do not apply to—
(1) An age distinction contained in that part of a Federal, State, or local statute or ordinance adopted by an elected, general purpose legislative body that—
(i) Provides any benefits or assistance to persons based on age; or
(ii) Establishes criteria for participation in age-related terms; or
(iii) Describes intended beneficiaries or target groups in age-related terms.
(2) Any employment practice of any employer, employment agency, labor organization, or any labor-management joint apprenticeship training program, except for any program or activity receiving Federal financial assistance for public service employment under the Comprehensive Employment and Training Act of 1974 (CETA) (29 U.S.C. 801
As used in this subpart:
(a)
(b)
(c)
(d)
(e)
(f)
The rules stated in this section are limited by the exceptions contained in §§ 4.313 and 4.314 of this subpart.
(a)
(b)
(1) Excluding individuals from, denying them the benefits of, or subjecting them to discrimination under, a program or activity receiving Federal financial assistance, or
(2) Denying or limiting individuals in their opportunity to participate in any program or activity receiving Federal financial assistance.
(c) The specific forms of age discrimination listed in paragraph (b) of this section do not necessarily constitute a complete list.
For purposes of §§ 4.313 and 4.314, the terms “normal operation” and “statutory objective” have the following meaning:
(a)
(b)
A recipient is permitted to take an action, otherwise prohibited by § 4.311, if the action reasonably takes into account age as a factor necessary to the normal operation or the achievement of any statutory objective of a program of activity. An action reasonably takes into account age as a factor necessary to the normal operation or the achievement of any statutory objective of a program or activity, if—
(a) Age is used as a measure or approximation of one or more other characteristics; and
(b) The other characteristic(s) must be measured or approximated in order for the normal operation of the program or activity to continue, or to achieve any statutory objective of the program or activity; and
(c) The other characteristic(s) can be reasonably measured or approximated by the use of age; and
(d) The other characteristic(s) are impractical to measure directly on an individual basis.
A recipient is permitted to take an action otherwise prohibited by § 4.311 which is based on a factor other than age, even though that action may have a disproportionate effect on persons of different ages. An action may be based on a factor other than age only if the factor bears a direct and substantial relationship to the normal operation of the program or activity or to the achievement of a statutory objective.
The burden of proving that an age distinction or other action falls within the exceptions outlined in §§ 4.313 and 4.314 is on the recipient of Federal financial assistance.
Each NRC recipient has primary responsibility to ensure that its programs and activities are in compliance with the Act and these regulations. Each recipient will sign an assurance of compliance that its programs and activities will be conducted in compliance with all the requirements imposed by the Act and these regulations. A recipient also has responsibility to maintain records, provide information, and to afford access to its records to NRC, to the extent required to determine whether it is in compliance with the Act and these regulations.
(a) NRC will provide written notice to each recipient of its obligations under the Act and these regulations, including its obligation under paragraph (b) of this section.
(b) Where a recipient makes available Federal financial assistance from NRC to a subrecipient, the recipient shall provide the subrecipient written notice of the subrecipient's obligations under the Act and these regulations.
(c) NRC will provide technical assistance, where necessary, to recipients to aid them in complying with the Act and these regulations.
(d) NRC will make available educational materials which set forth the rights and obligations of recipients and beneficiaries under the Act and these regulations.
Each recipient shall:
(a) Make available upon request to NRC information necessary to determine whether the recipient is complying with the Act and these regulations.
(b) Permit reasonable access by NRC to the recipient's books, records, accounts, facilities, and other sources of information to the extent necessary to determine whether the recipient is in compliance with the Act and these regulations.
(a) NRC may conduct compliance reviews and preaward reviews of recipients or use other similar procedures that will permit it to investigate and correct violations of the Act and these regulations. NRC may conduct these reviews even in absence of a complaint against a recipient. The review may be as comprehensive as necessary to determine whether a violation of these regulations has occurred.
(b) If a compliance review or preaward review indicates a violation of the Act or these regulations, NRC will attempt to achieve voluntary compliance with the Act. If voluntary compliance cannot be achieved, NRC will arrange for enforcement as described in § 4.336.
(a) Any person, individually or as a member of a class or on behalf of others, may file a complaint with NRC, alleging discrimination prohibited by the Act or these regulations based on an action occurring on or after July 1, 1979. A complainant shall file a complaint within 180 days from the date the complainant first had knowledge of the alleged act of discrimination. However, for good cause shown, NRC may extend this time limit.
(b) NRC will attempt to facilitate the filing of complaints wherever possible, including taking the following measures:
(1) Accepting a complaint as sufficient for further processing that—
(i) Is made in writing;
(ii) Alleges a violation of the Act;
(iii) Identifies the parties involved and the date the complainant first had knowledge of the alleged violation;
(iv) Describes generally the action or practice complained of; and
(v) Is signed by the complainant.
(2) Freely permitting a complainant to add information to the complaint to
(3) Notifying the complainant and the recipient of their rights and obligations under the complaint procedure, including the right to have a representative at all stages of the complaint procedures.
(4) Notifying the complainant and the recipient (or their representatives) of their right to contact NRC for information and assistance regarding the complaint resolution process.
(c) Each recipient and complainant shall participate actively in efforts toward speedy resolution of the complaint.
(d) NRC will return to the complainant any complaint outside the jurisdiction of these regulations, and will state the reason(s) why it is outside the jurisdiction of these regulations.
(a) Referral of complaints for mediation. NRC will refer to a mediation agency designated by the Secretary of the Department of Health and Human Services all complaints that—
(1) Fall within the jurisdiction of the Act and these regulations; and
(2) Contain all information necessary for further processing.
(b) Both the complainant and the recipient shall participate in the mediation process to the extent necessary to reach an agreement or make an informed judgment that an agreement is not possible. There must be at least one meeting with the mediator before NRC will accept a judgment that an agreement is not possible. However, the recipient and the complainant need not meet with the mediator at the same time.
(c) If the complainant and the recipient reach an agreement, the mediator shall prepare a written statement of the agreement and have the complainant and recipient sign it. The mediator shall send a copy of the agreement to NRC. NRC will take no further action on the complaint unless the complainant or recipient fails to comply with the agreement.
(d) The mediator shall protect the confidentiality of all information obtained in the course of the mediation process. No mediator shall testify in any adjudicative proceeding, produce any document, or otherwise disclose any information obtained in the course of the mediation process without prior approval of the head of the agency appointing the mediator.
(e) NRC will use the mediation process for a maximum of 60 days after receiving a complaint. Mediation ends if—
(1) From the time NRC receives the complaint 60 days elapse; or
(2) Prior to the end of that 60-day period, the mediator determines an agreement is reached; or
(3) Prior to the end of that 60-day period, the mediator determines that an agreement cannot be reached.
(f) The mediator shall return unresolved complaints to NRC.
(a)
(2) As part of the initial investigation, NRC will use informal fact-finding methods, including joint or separate discussions with the complaint and recipient to establish the facts and, if possible, settle the complaint on terms that are mutually agreeable to the parties. NRC may seek the assistance of any involved State program agency.
(3) NRC will put any agreement in writing and have it signed by the parties and an authorized official at NRC.
(4) The settlement shall not affect the operation of any other enforcement effort of NRC, including compliance reviews and investigation of other complaints which may involve the recipient.
(5) Settlement of a complaint under this section will not constitute a finding of discrimination by the NRC against a recipient or an admission of discrimination by the recipient.
(b)
A recipient may not engage in acts of intimidation or retaliation against any person who—
(a) Attempts to assert a right protected by the Act or these regulations; or
(b) Cooperates in any mediation, investigation, hearing, or other part of NRC's investigation, conciliation, and enforcement process.
(a) NRC may enforce the Act and these regulations through—
(1) Termination of a recipient's Federal financial assistance from NRC under the program or activity involved where the recipient has violated the Act or these regulations. The determination of the recipient's violation may be made only after a recipient has had an opportunity for a hearing on the record before an administrative law judge. Therefore, cases that are settled in mediation, or prior to a hearing, will not involve termination of a recipient's Federal fiancial assistance from NRC.
(2) Any other means authorized by law including but not limited to—
(i) Referral to the Department of Justice for proceedings to enforce any rights of the United States or obligations of the recipients created by the Act or these regulations.
(ii) Use of any requirement of or referral to any Federal, State, or local government agency that will have the effect of correcting a violation of the Act or these regulations.
(b) NRC will limit any termination under § 4.336(a)(1) to the particular recipient and particular program or activity NRC finds in violation of Act or these regulations. NRC will not base any part of a termination on a finding with respect to any program or activity of the recipient that does not receive Federal financial assistance from NRC.
(c) NRC will take no action under paragraph (a) until—
(1) The Commission, or designee, has advised the recipient of its failure to comply with the Act or these regulations and has determined that voluntary compliance cannot be obtained.
(2) 30 days have elapsed after the Commission, or designee, has sent a written report of the circumstances and grounds of the action to the committees of the Congress having legislative jurisdiction over the Federal program or activity involved. A report will be filed whenever any action is taken under paragraph (a) of this section.
(d) NRC also may defer granting new Federal financial assistance to a recipient when termination proceedings under § 4.336(a)(1) are initiated.
(1) New Federal financial assistance includes all assistance for which NRC requires an application or approval, including renewal or continuation of existing activities or authorization of new activities, during the deferral period. New Federal financial assistance does not include increases in funding as a result of change computation of formula awards or assistance approved prior to the beginning of termination proceedings under § 4.336(a)(1).
(2) NRC will not begin a deferral until the recipient has received a notice of an opportunity for a hearing under § 4.336(a)(1). NRC will not continue a deferral for more than 60 days unless a hearing has begun within that time or the time for beginning the hearings has been extended by mutual consent of the recipient and NRC. NRC will not continue a deferral for more than 30 days after the close of the hearing, unless the hearing results in a finding against the recipient.
Certain NRC procedural provisions applicable to title VI of the Civil Rights Act of 1964 apply to NRC enforcement of these regulations. They are §§ 4.61 through 4.64 and §§ 4.71 through 4.75.
(a) Where NRC finds a recipient has discriminated on the basis of age, the recipient shall take any remedial action that NRC may require to overcome the effects of the discrimination.
(b) Even in the absence of a finding of discrimination, a recipient may take affirmative action to overcome the effects of conditions that resulted in limited participation in the recipient's program or activity on the basis of age.
(c) If a recipient, operating a program that serves the elderly or children in addition to persons of other ages, provides special benefits to the elderly or to children, the provision of those benefits shall be presumed to be voluntary affirmative action provided that it does not have the effect of excluding otherwise eligible persons from participation in the program.
(a) When NRC withholds funds from a recipient under these regulations, the Commission, or designee, may disburse the withheld funds directly to an alternate recipient, any public or nonprofit private organization or agency, or State or political subdivision of the State.
(b) Any alternative recipient will be required to demonstrate—
(1) The ability to comply with these regulations; and
(2) The ability to achieve the goals of the Federal statute authorizing the program or activity.
(a) A complainant may file a civil action following the exhaustion of administrative remedies under the Act. Administrative remedies are exhausted if—
(1) 180 days have elapsed since the complainant filed the complaint and NRC has made no finding with regard to the complaint; or
(2) NRC issues any finding in favor of the recipient.
(b) If NRC fails to make a finding within 180 days or issues a finding in favor of the recipient, NRC will—
(1) Promptly advise the complainant; and
(2) Advise the complainant of his or her right to bring a civil action under section 305(e) of the Act of injunctive relief that will effect the purposes of the Act; and
(3) Inform the complainant that—
(i) The complainant may bring a civil action only in a United States District Court for the district in which the recipient is found or transacts business;
(ii) A complainant prevailing in a civil action has the right to be awarded the costs of the action, including reasonable attorney's fees, but that the complainant must demand these costs in the complaint;
(iii) That before commencing the action, the complainant shall give 30 days notice by registered mail to the Commission, the Secretary of the Department of Health and Human Services, the Attorney General of the United States, and the recipient;
(iv) The notice must state the relief requested, the court in which the complainant is bringing the action, and whether or not attorney's fees are demanded in the event the complainant prevails; and
(v) The complainant may not bring an action if the same alleged violation of the Act by the same recipient is the subject of pending action in any court of the United States.
The NRC shall submit to the Secretary of Health and Human Services, not later than December 31 of each year, a report which—
(a) Describes in detail the steps taken during the preceding fiscal year to carry out the Act; and
(b) Contains data on the frequency, type, and resolution of complaints and on any compliance reviews, sufficient to permit analysis of the agency's progress in reducing age discrimination in programs receiving Federal financial assistance from NRC; and
(c) Contains data directly relevant to the extent of any pattern or practice of age discrimination which NRC has identified in any programs receiving Federal financial assistance from NRC and to progress toward eliminating it; and
(d) Contains evaluative or interpretative information which NRC determines is useful in analyzing agency
(e) Contains whatever other data the Secretary of HHS may require.
This part effectuates section 119 of the Rehabilitation, Comprehensive Services, and Developmental Disabilities Amendments of 1978, which amended section 504 of the Rehabilitation Act of 1973 to prohibit discrimination on the basis of handicap in programs or activities conducted by Executive agencies or the United States Postal Service.
This part applies to all programs or activities conducted by the agency.
For purposes of this part, the term—
As used in this definition, the phrase:
(1)
(i) Any physiological disorder or condition, cosmetic disfigurement, or anatomical loss affecting one or more of the following body systems: Neurological; musculoskeletal; special sense organs; respiratory, including speech organs; cardiovascular; reproductive; digestive; genitourinary; hemic and lymphatic; skin; and endocrine; or
(ii) Any mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities. The term “physical or mental impairment” includes, but is not limited to, such diseases and conditions as orthopedic, visual, speech, and hearing impairments, cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation, emotional illness, and drug addiction and alcoholism.
(2)
(3)
(4)
(i) Has a physical or mental impairment that does not substantially limit major life activities but is treated by the agency as constituting such a limitation;
(ii) Has a physical or mental impairment that substantially limits major life activities only as a result of the attitudes of others toward such impairment; or
(iii) Has none of the impairments defined in paragraph (1) of this definition but is treated by the agency as having such an impairment.
(1) With respect to preschool, elementary, or secondary education services provided by the agency, a handicapped person who is a member of a class of persons otherwise entitled by statute, regulation, or agency policy to receive education services from the agency.
(2) With respect to any other agency program or activity under which a person is required to perform services or to achieve a level of accomplishment, a handicapped person who meets the essential eligibility requirements and who can achieve the purpose of the program or activity without modifications in the program or activity that the agency can demonstrate would result in a fundamental alteration in its nature;
(3) With respect to any other program or activity, a handicapped person who meets the essential eligibility requirements for participation in, or receipt of benefits from, that program or activity; and
(4)
(a) The agency shall, by August 24, 1987, evaluate its current policies and practices, and the effects thereof, that do not or may not meet the requirements of this part, and, to the extent modification of any such policies and practices is required, the agency shall proceed to make the necessary modifications.
(b) The agency shall provide an opportunity to interested persons, including handicapped persons or organizations representing handicapped persons, to participate in the self-evaluation process by submitting comments (both oral and written).
(c) The agency shall, until three years following the completion of the self-evaluation, maintain on file and make available for public inspection:
(1) A description of areas examined and any problems identified, and
(2) A description of any modifications made.
The agency shall make available to employees, applicants, participants, beneficiaries, and other interested persons such information regarding the provisions of this part and its applicability to the programs or activities conducted by the agency, and make such information available to them in such manner as the head of the agency
(a) No qualified handicapped person shall, on the basis of handicap, be excluded from participation in, be denied the benefits of, or otherwise be subjected to discrimination under any program or activity conducted by the agency.
(b)(1) The agency, in providing any aid, benefit, or service, may not, directly or through contractual, licensing, or other arrangements, on the basis of handicap—
(i) Deny a qualified handicapped person the opportunity to participate in or benefit from the aid, benefit, or service;
(ii) Afford a qualified handicapped person an opportunity to participate in or benefit from the aid, benefit, or service that is not equal to that afforded others;
(iii) Provide a qualified handicapped person with an aid, benefit, or service that is not as effective in affording equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement as that provided to others;
(iv) Provide different or separate aid, benefits, or services to handicapped persons or to any class of handicapped persons than is provided to others unless such action is necessary to provide qualified handicapped persons with aid, benefits, or services that are as effective as those provided to others;
(v) Deny a qualified handicapped person the opportunity to participate as a member of planning or advisory boards; or
(vi) Otherwise limit a qualified handicapped person in the enjoyment of any right, privilege, advantage, or opportunity enjoyed by others receiving the aid, benefit, or service.
(2) The agency may not deny a qualified handicapped person the opportunity to participate in programs or activities that are not separate or different, despite the existence of permissibly separate or different programs or activities.
(3) The agency may not, directly or through contractual or other arrangments, utilize criteria or methods of administration the purpose or effect of which would—
(i) Subject qualified handicapped persons to discrimination on the basis of handicap; or
(ii) Defeat or substantially impair accomplishment of the objectives of a program or activity with respect to handicapped persons.
(4) The agency may not, in determining the site or location of a facility, make selections the purpose or effect of which would—
(i) Exclude handicapped persons from, deny them the benefits of, or otherwise subject them to discrimination under any program or activity conducted by the agency; or
(ii) Defeat or substantially impair the accomplishment of the objectives of a program or activity with respect to handicapped persons.
(5) The agency, in the selection of procurement contractors, may not use criteria that subject qualified handicapped persons to discrimination on the basis of handicap.
(6) The agency may not administer a licensing or certification program in a manner that subjects qualified handicapped persons to discrimination on the basis of handicap, nor may the agency establish requirements for the programs or activities of licensees or certified entities that subject qualified handicapped persons to discrimination on the basis of handicap. However, the programs or activities of entities that are licensed or certified by the agency are not, themselves, covered by this part.
(c) The exclusion of nonhandicapped persons from the benefits of a program limited by Federal statute or Executive order to handicapped persons or the exclusion of a specific class of handicapped persons from a program limited by Federal statute or Executive order to a different class of handicapped persons is not prohibited by this part.
(d) The agency shall administer programs and activities in the most integrated setting appropriate to the needs of qualified handicapped persons.
No qualified handicapped person shall, on the basis of handicap, be subjected to discrimination in employment under any program or activity conducted by the agency. The definitions, requirements, and procedures of section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 791), as established by the Equal Employment Opportunity Commission in 29 CFR part 1613, shall apply to employment in federally conducted programs or activities.
Except as otherwise provided in § 4.550, no qualified handicapped person shall, because the agency's facilities are inaccessible to or unusable by handicapped persons, be denied the benefits of, be excluded from participation in, or otherwise be subjected to discrimination under any program or activity conducted by the agency.
(a)
(1) Necessarily require the agency to make each of its existing facilities accessible to and usable by handicapped persons;
(2) In the case of historic preservation programs, require the agency to take any action that would result in a substantial impairment of significant historic features of an historic property; or
(3) Require the agency to take any action that it can demonstrate would result in a fundamental alteration in the nature of a program or activity or in undue financial and administrative burdens. In those circumstances where agency personnel believe that the proposed action would fundamentally alter the program or activity or would result in undue financial and administrative burdens, the agency has the burden of proving that compliance with § 4.550(a) would result in such alteration or burdens. The decision that compliance would result in such alteration or burdens must be made by the agency head or his or her designee after considering all agency resources available for use in the funding and operation of the conducted program or activity, and must be accompanied by a written statement of the reasons for reaching that conclusion. If an action would result in such an alteration or such burdens, the agency shall take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that handicapped persons receive the benefits and services of the program or activity.
(b)
(2)
(i) Using audio-visual materials and devices to depict those portions of an historic property that cannot otherwise be made accessible;
(ii) Assigning persons to guide handicapped persons into or through portions of historic properties that cannot otherwise be made accessible; or
(iii) Adopting other innovative methods.
(c)
(d)
(1) Identify physical obstacles in the agency's facilities that limit the accessibility of its programs or activities to handicapped persons;
(2) Describe in detail the methods that will be used to make the facilities accessible;
(3) Specify the schedule for taking the steps necessary to achieve compliance with this section and, if the time period of the transition plan is longer than one year, identify steps that will be taken during each year of the transition period; and
(4) Indicate the official responsible for implementation of the plan.
Each building or part of a building that is constructed or altered by, on behalf of, or for the use of the agency shall be designed, constructed, or altered so as to be readily accessible to and usable by handicapped persons. The definitions, requirements, and standards of the Architectural Barriers Act (42 U.S.C. 4151-4157), as established in 41 CFR 101-19.600 to 101-19.607, apply to buildings covered by this section.
(a) The agency shall take appropriate steps to ensure effective communication with applicants, participants, personnel of other Federal entities, and members of the public.
(1) The agency shall furnish appropriate auxiliary aids where necessary to afford a handicapped person an equal opportunity to participate in, and enjoy the benefits of, a program or activity conducted by the agency.
(i) In determining what type of auxiliary aid is necessary, the agency shall give primary consideration to the requests of the handicapped person.
(ii) The agency need not provide individually prescribed devices, readers for personal use or study, or other devices of a personal nature.
(2) Where the agency communicates with applicants and beneficiaries by telephone, telecommunication devices for deaf person (TDD's) or equally effective telecommunication systems shall be used.
(b) The agency shall ensure that interested persons, including persons with impaired vision or hearing, can obtain information as to the existence and location of accessible services, activities, and facilities.
(c) The agency shall provide signage at a primary entrance to each of its inaccessible facilities, directing users to a location at which they can obtain information about accessible facilities. The international symbol for accessibility shall be used at each primary entrance of an accessible facility.
(d) This section does not require the agency to take any action that it can
(a) Except as provided in paragraph (b) of this section, this section applies to all allegations of discrimination on the basis of handicap in programs or activities conducted by the agency.
(b) The agency shall process complaints alleging violations of section 504 with respect to employment according to the procedures established by the Equal Employment Opportunity Commission in 29 CFR part 1613 pursuant to section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 791).
(c) The Civil Rights Program Manager, Office of Small and Disadvantaged Business Utilization/Civil Rights, shall be responsible for coordinating implementation of this section. Complaints may be sent to Nuclear Regulatory Commission, Washington, DC 20555.
(d) The agency shall accept and investigate all complete complaints for which it has jurisdiction. All complete complaints must be filed within 180 days of the alleged act of discrimination. The agency may extend this time period for good cause.
(e) If the agency receives a complaint over which it does not have jurisdiction, it shall promptly notify the complainant and shall make reasonable efforts to refer the complaint to the appropriate government entity.
(f) The agency shall notify the Architectural and Transportation Barriers Compliance Board upon receipt of any complaint alleging that a building or facility that is subject to the Architectural Barriers Act of 1968, as amended (42 U.S.C. 4151-4157), or section 502 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 792), is not readily accessible to and usable by handicapped persons.
(g) Within 180 days of the receipt of a complete complaint for which it has jurisdiction, the agency shall notify the complainant of the results of the investigation in a letter containing—
(1) Findings of fact and conclusions of law;
(2) A description of a remedy for each violation found; and
(3) A notice of the right to appeal.
(h) Appeals of the findings of fact and conclusions of law or remedies must be filed by the complainant within 90 days of receipt from the agency of the letter required by § 4.570(g). The agency may extend this time for good cause.
(i) Timely appeals shall be accepted and processed by the head of the agency.
(j) The head of the agency shall notify the complainant of the results of the appeal within 60 days of the receipt of the request. If the head of the agency determines that additional information is needed from the complainant, he or she shall have 60 days from the date of receipt of the additional information to make his or her determination on the appeal.
(k) The time limits cited in paragraphs (g) and (j) of this section may be extended with the permission of the Assistant Attorney General.
(l) The agency may delegate its authority for conducting complaint investigations to other Federal agencies, except that the authority for making
(a)
(b)
(c)
(d)
(e)
20 U.S.C. 1681, 1682, 1683, 1685, 1686, 1687, 1688.
The purpose of these Title IX regulations is to effectuate Title IX of the Education Amendments of 1972, as amended (except sections 904 and 906 of those Amendments) (20 U.S.C. 1681, 1682, 1683, 1685, 1686, 1687, 1688), which is designed to eliminate (with certain exceptions) discrimination on the basis of sex in any education program or activity receiving Federal financial assistance, whether or not such program or activity is offered or sponsored by an educational institution as defined in these Title IX regulations. The effective date of these Title IX regulations shall be September 29, 2000.
As used in these Title IX regulations, the term:
(1) A grant or loan of Federal financial assistance, including funds made available for:
(i) The acquisition, construction, renovation, restoration, or repair of a building or facility or any portion thereof; and
(ii) Scholarships, loans, grants, wages, or other funds extended to any entity for payment to or on behalf of students admitted to that entity, or extended directly to such students for payment to that entity.
(2) A grant of Federal real or personal property or any interest therein, including surplus property, and the proceeds of the sale or transfer of such property, if the Federal share of the fair market value of the property is not, upon such sale or transfer, properly accounted for to the Federal Government.
(3) Provision of the services of Federal personnel.
(4) Sale or lease of Federal property or any interest therein at nominal consideration, or at consideration reduced for the purpose of assisting the recipient or in recognition of public interest to be served thereby, or permission to use Federal property or any interest therein without consideration.
(5) Any other contract, agreement, or arrangement that has as one of its purposes the provision of assistance to any education program or activity, except a contract of insurance or guaranty.
(1) Offers academic study beyond the bachelor of arts or bachelor of science degree, whether or not leading to a certificate of any higher degree in the liberal arts and sciences;
(2) Awards any degree in a professional field beyond the first professional degree (regardless of whether the first professional degree in such field is awarded by an institution of undergraduate higher education or professional education); or
(3) Awards no degree and offers no further academic study, but operates ordinarily for the purpose of facilitating research by persons who have received the highest graduate degree in any field of study.
(1) An institution offering at least two but less than four years of college-level study beyond the high school level, leading to a diploma or an associate degree, or wholly or principally creditable toward a baccalaureate degree; or
(2) An institution offering academic study leading to a baccalaureate degree; or
(3) An agency or body that certifies credentials or offers degrees, but that may or may not offer academic study.
(a)
(b)
(c)
(1) Evaluate, in terms of the requirements of these Title IX regulations, its current policies and practices and the effects thereof concerning admission of students, treatment of students, and employment of both academic and non-academic personnel working in connection with the recipient's education program or activity;
(2) Modify any of these policies and practices that do not or may not meet the requirements of these Title IX regulations; and
(3) Take appropriate remedial steps to eliminate the effects of any discrimination that resulted or may have resulted from adherence to these policies and practices.
(d)
(a)
(b)
(2) In the case of Federal financial assistance extended to provide personal property, such assurance shall obligate the recipient for the period during which it retains ownership or possession of the property.
(3) In all other cases such assurance shall obligate the recipient for the period during which Federal financial assistance is extended.
(c)
(2) The designated agency official will specify the extent to which such assurances will be required of the applicant's or recipient's subgrantees, contractors, subcontractors, transferees, or successors in interest.
If a recipient sells or otherwise transfers property financed in whole or in part with Federal financial assistance to a transferee that operates any education program or activity, and the Federal share of the fair market value of the property is not upon such sale or transfer properly accounted for to the Federal Government, both the transferor and the transferee shall be deemed to be recipients, subject to the provisions of §§ 5.205 through 5.235(a).
(a)
(b)
(c)
The obligation to comply with these Title IX regulations is not obviated or alleviated because employment opportunities in any occupation or profession are or may be more limited for members of one sex than for members of the other sex.
(a)
(b)
(a)
(2) Each recipient shall make the initial notification required by paragraph (a)(1) of this section within 90 days of September 29, 2000 or of the date these Title IX regulations first apply to such recipient, whichever comes later, which notification shall include publication in:
(i) Newspapers and magazines operated by such recipient or by student, alumnae, or alumni groups for or in connection with such recipient; and
(ii) Memoranda or other written communications distributed to every student and employee of such recipient.
(b)
(2) A recipient shall not use or distribute a publication of the type described in paragraph (b)(1) of this section that suggests, by text or illustration, that such recipient treats applicants, students, or employees differently on the basis of sex except as such treatment is permitted by these Title IX regulations.
(c)
Except as provided in §§ 5.205 through 5.235(a), these Title IX regulations apply to every recipient and to each education program or activity operated by such recipient that receives Federal financial assistance.
(a)
(b)
These Title IX regulations do not apply to an educational institution whose primary purpose is the training of individuals for a military service of the United States or for the merchant marine.
(a)
(b)
(c)
(a) Admissions to educational institutions prior to June 24, 1973, are not covered by these Title IX regulations.
(b)
(c)
(d)
(e)
(a)
(1) Admitted students of only one sex as regular students as of June 23, 1972; or
(2) Admitted students of only one sex as regular students as of June 23, 1965, but thereafter admitted, as regular students, students of the sex not admitted prior to June 23, 1965.
(b)
(a)
(b)
(1) State the name, address, and Federal Interagency Committee on Education Code of the educational institution submitting such plan, the administratively separate units to which the plan is applicable, and the name, address, and telephone number of the person to whom questions concerning the plan may be addressed. The person who submits the plan shall be the chief administrator or president of the institution, or another individual legally authorized to bind the institution to all actions set forth in the plan.
(2) State whether the educational institution or administratively separate unit admits students of both sexes as regular students and, if so, when it began to do so.
(3) Identify and describe with respect to the educational institution or administratively separate unit any obstacles to admitting students without discrimination on the basis of sex.
(4) Describe in detail the steps necessary to eliminate as soon as practicable each obstacle so identified and indicate the schedule for taking these steps and the individual directly responsible for their implementation.
(5) Include estimates of the number of students, by sex, expected to apply for, be admitted to, and enter each class during the period covered by the plan.
(c)
(d)
(a) This section, which applies to all provisions of these Title IX regulations, addresses statutory amendments to Title IX.
(b) These Title IX regulations shall not apply to or preclude:
(1) Any program or activity of the American Legion undertaken in connection with the organization or operation of any Boys State conference, Boys Nation conference, Girls State conference, or Girls Nation conference;
(2) Any program or activity of a secondary school or educational institution specifically for:
(i) The promotion of any Boys State conference, Boys Nation conference, Girls State conference, or Girls Nation conference; or
(ii) The selection of students to attend any such conference;
(3) Father-son or mother-daughter activities at an educational institution or in an education program or activity, but if such activities are provided for students of one sex, opportunities for reasonably comparable activities shall be provided to students of the other sex;
(4) Any scholarship or other financial assistance awarded by an institution of higher education to an individual because such individual has received such award in a single-sex pageant based upon a combination of factors related to the individual's personal appearance, poise, and talent. The pageant, however, must comply with other nondiscrimination provisions of Federal law.
(c)
(1) All of the operations of any entity described in paragraphs (c)(1)(i) through (iv) of this section, any part of which is extended Federal financial assistance:
(i)(A) A department, agency, special purpose district, or other instrumentality of a State or of a local government; or
(B) The entity of such State or local government that distributes such assistance and each such department or agency (and each other State or local government entity) to which the assistance is extended, in the case of assistance to a State or local government;
(ii)(A) A college, university, or other postsecondary institution, or a public system of higher education; or
(B) A local educational agency (as defined in section 8801 of title 20), system of vocational education, or other school system;
(iii)(A) An entire corporation, partnership, or other private organization, or an entire sole proprietorship—
(
(
(B) The entire plant or other comparable, geographically separate facility to which Federal financial assistance is extended, in the case of any other corporation, partnership, private organization, or sole proprietorship; or
(iv) Any other entity that is established by two or more of the entities described in paragraphs (c)(1)(i), (ii), or (iii) of this section.
(2)(i)
(ii) For example, all of the operations of a college, university, or other postsecondary institution, including but not limited to traditional educational operations, faculty and student housing, campus shuttle bus service, campus restaurants, the bookstore, and other commercial activities are part of a “program or activity” subject to
(d)(1) Nothing in these Title IX regulations shall be construed to require or prohibit any person, or public or private entity, to provide or pay for any benefit or service, including the use of facilities, related to an abortion. Medical procedures, benefits, services, and the use of facilities, necessary to save the life of a pregnant woman or to address complications related to an abortion are not subject to this section.
(2) Nothing in this section shall be construed to permit a penalty to be imposed on any person or individual because such person or individual is seeking or has received any benefit or service related to a legal abortion. Accordingly, subject to paragraph (d)(1) of this section, no person shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any academic, extracurricular, research, occupational training, employment, or other educational program or activity operated by a recipient that receives Federal financial assistance because such individual has sought or received, or is seeking, a legal abortion, or any benefit or service related to a legal abortion.
(a)
(b)
(i) Give preference to one person over another on the basis of sex, by ranking applicants separately on such basis, or otherwise;
(ii) Apply numerical limitations upon the number or proportion of persons of either sex who may be admitted; or
(iii) Otherwise treat one individual differently from another on the basis of sex.
(2) A recipient shall not administer or operate any test or other criterion for admission that has a disproportionately adverse effect on persons on the basis of sex unless the use of such test or criterion is shown to predict validly success in the education program or activity in question and alternative tests or criteria that do not have such a disproportionately adverse effect are shown to be unavailable.
(c)
(1) Shall not apply any rule concerning the actual or potential parental, family, or marital status of a student or applicant that treats persons differently on the basis of sex;
(2) Shall not discriminate against or exclude any person on the basis of pregnancy, childbirth, termination of pregnancy, or recovery therefrom, or establish or follow any rule or practice that so discriminates or excludes;
(3) Subject to § 5.235(d), shall treat disabilities related to pregnancy, childbirth, termination of pregnancy, or recovery therefrom in the same manner and under the same policies as any other temporary disability or physical condition; and
(4) Shall not make pre-admission inquiry as to the marital status of an applicant for admission, including whether such applicant is “Miss” or “Mrs.” A recipient may make pre-admission inquiry as to the sex of an applicant for admission, but only if such inquiry is made equally of such applicants of both sexes and if the results of such inquiry are not used in connection with discrimination prohibited by these Title IX regulations.
A recipient to which §§ 5.300 through 5.310 apply shall not give preference to applicants for admission, on the basis of attendance at any educational institution or other school or entity that
(a)
(b)
(a)
(b)
(1) Treat one person differently from another in determining whether such person satisfies any requirement or condition for the provision of such aid, benefit, or service;
(2) Provide different aid, benefits, or services or provide aid, benefits, or services in a different manner;
(3) Deny any person any such aid, benefit, or service;
(4) Subject any person to separate or different rules of behavior, sanctions, or other treatment;
(5) Apply any rule concerning the domicile or residence of a student or applicant, including eligibility for in-state fees and tuition;
(6) Aid or perpetuate discrimination against any person by providing significant assistance to any agency, organization, or person that discriminates on the basis of sex in providing any aid, benefit, or service to students or employees;
(7) Otherwise limit any person in the enjoyment of any right, privilege, advantage, or opportunity.
(c)
(d)
(2) Such recipient:
(i) Shall develop and implement a procedure designed to assure itself that the operator or sponsor of such other education program or activity takes no action affecting any applicant, student, or employee of such recipient that these Title IX regulations would prohibit such recipient from taking; and
(ii) Shall not facilitate, require, permit, or consider such participation if such action occurs.
(a)
(b)
(2) Housing provided by a recipient to students of one sex, when compared to that provided to students of the other sex, shall be as a whole:
(i) Proportionate in quantity to the number of students of that sex applying for such housing; and
(ii) Comparable in quality and cost to the student.
(c)
(2)(i) A recipient which, through solicitation, listing, approval of housing, or otherwise, assists any agency, organization, or person in making housing available to any of its students, shall take such reasonable action as may be necessary to assure itself that such housing as is provided to students of one sex, when compared to that provided to students of the other sex, is as a whole:
(A) Proportionate in quantity; and
(B) Comparable in quality and cost to the student.
(ii) A recipient may render such assistance to any agency, organization, or person that provides all or part of such housing to students of only one sex.
A recipient may provide separate toilet, locker room, and shower facilities on the basis of sex, but such facilities provided for students of one sex shall be comparable to such facilities provided for students of the other sex.
(a) A recipient shall not provide any course or otherwise carry out any of its education program or activity separately on the basis of sex, or require or refuse participation therein by any of its students on such basis, including health, physical education, industrial, business, vocational, technical, home economics, music, and adult education courses.
(b)(1) With respect to classes and activities in physical education at the elementary school level, the recipient shall comply fully with this section as expeditiously as possible but in no event later than one year from September 29, 2000. With respect to physical education classes and activities at the secondary and post-secondary levels, the recipient shall comply fully with this section as expeditiously as possible but in no event later than three years from September 29, 2000.
(2) This section does not prohibit grouping of students in physical education classes and activities by ability as assessed by objective standards of individual performance developed and applied without regard to sex.
(3) This section does not prohibit separation of students by sex within physical education classes or activities during participation in wrestling, boxing, rugby, ice hockey, football, basketball, and other sports the purpose or major activity of which involves bodily contact.
(4) Where use of a single standard of measuring skill or progress in a physical education class has an adverse effect on members of one sex, the recipient shall use appropriate standards that do not have such effect.
(5) Portions of classes in elementary and secondary schools, or portions of education programs or activities, that deal exclusively with human sexuality may be conducted in separate sessions for boys and girls.
(6) Recipients may make requirements based on vocal range or quality that may result in a chorus or choruses of one or predominantly one sex.
A recipient that is a local educational agency shall not, on the basis of sex, exclude any person from admission to:
(a) Any institution of vocational education operated by such recipient; or
(b) Any other school or educational unit operated by such recipient, unless such recipient otherwise makes available to such person, pursuant to the same policies and criteria of admission, courses, services, and facilities comparable to each course, service, and facility offered in or through such schools.
(a)
(b)
(c)
(a)
(1) On the basis of sex, provide different amounts or types of such assistance, limit eligibility for such assistance that is of any particular type or source, apply different criteria, or otherwise discriminate;
(2) Through solicitation, listing, approval, provision of facilities, or other services, assist any foundation, trust, agency, organization, or person that provides assistance to any of such recipient's students in a manner that discriminates on the basis of sex; or
(3) Apply any rule or assist in application of any rule concerning eligibility for such assistance that treats persons of one sex differently from persons of the other sex with regard to marital or parental status.
(b)
(2) To ensure nondiscriminatory awards of assistance as required in paragraph (b)(1) of this section, recipients shall develop and use procedures under which:
(i) Students are selected for award of financial assistance on the basis of nondiscriminatory criteria and not on the basis of availability of funds restricted to members of a particular sex;
(ii) An appropriate sex-restricted scholarship, fellowship, or other form of financial assistance is allocated to each student selected under paragraph (b)(2)(i) of this section; and
(iii) No student is denied the award for which he or she was selected under paragraph (b)(2)(i) of this section because of the absence of a scholarship, fellowship, or other form of financial assistance designated for a member of that student's sex.
(c)
(2) A recipient may provide separate athletic scholarships or grants-in-aid for members of each sex as part of separate athletic teams for members of each sex to the extent consistent with this paragraph (c) and § 5.450.
(a)
(1) Shall assure itself that such employment is made available without discrimination on the basis of sex; and
(2) Shall not render such services to any agency, organization, or person that discriminates on the basis of sex in its employment practices.
(b)
Subject to § 5.235(d), in providing a medical, hospital, accident, or life insurance benefit, service, policy, or plan to any of its students, a recipient shall not discriminate on the basis of sex, or provide such benefit, service, policy, or plan in a manner that would violate §§ 5.500 through 5.550 if it were provided to employees of the recipient. This section shall not prohibit a recipient from providing any benefit or service that may be used by a different proportion of students of one sex than of the other, including family planning services. However, any recipient that provides full coverage health service shall provide gynecological care.
(a)
(b)
(2) A recipient may require such a student to obtain the certification of a physician that the student is physically and emotionally able to continue participation as long as such a certification is required of all students for other physical or emotional conditions requiring the attention of a physician.
(3) A recipient that operates a portion of its education program or activity separately for pregnant students, admittance to which is completely voluntary on the part of the student as provided in paragraph (b)(1) of this section, shall ensure that the separate portion is comparable to that offered to non-pregnant students.
(4) Subject to § 5.235(d), a recipient shall treat pregnancy, childbirth, false pregnancy, termination of pregnancy
(5) In the case of a recipient that does not maintain a leave policy for its students, or in the case of a student who does not otherwise qualify for leave under such a policy, a recipient shall treat pregnancy, childbirth, false pregnancy, termination of pregnancy, and recovery therefrom as a justification for a leave of absence for as long a period of time as is deemed medically necessary by the student's physician, at the conclusion of which the student shall be reinstated to the status that she held when the leave began.
(a)
(b)
(c)
(i) Whether the selection of sports and levels of competition effectively accommodate the interests and abilities of members of both sexes;
(ii) The provision of equipment and supplies;
(iii) Scheduling of games and practice time;
(iv) Travel and per diem allowance;
(v) Opportunity to receive coaching and academic tutoring;
(vi) Assignment and compensation of coaches and tutors;
(vii) Provision of locker rooms, practice, and competitive facilities;
(viii) Provision of medical and training facilities and services;
(ix) Provision of housing and dining facilities and services;
(x) Publicity.
(2) For purposes of paragraph (c)(1) of this section, unequal aggregate expenditures for members of each sex or unequal expenditures for male and female teams if a recipient operates or sponsors separate teams will not constitute noncompliance with this section, but the designated agency official may consider the failure to provide necessary funds for teams for one sex in assessing equality of opportunity for members of each sex.
(d)
Nothing in these Title IX regulations shall be interpreted as requiring or prohibiting or abridging in any way the use of particular textbooks or curricular materials.
(a)
(2) A recipient shall make all employment decisions in any education program or activity operated by such recipient in a nondiscriminatory manner and shall not limit, segregate, or classify applicants or employees in any way that could adversely affect any applicant's or employee's employment opportunities or status because of sex.
(3) A recipient shall not enter into any contractual or other relationship which directly or indirectly has the effect of subjecting employees or students to discrimination prohibited by §§ 5.500 through 5.550, including relationships with employment and referral agencies, with labor unions, and with organizations providing or administering fringe benefits to employees of the recipient.
(4) A recipient shall not grant preferences to applicants for employment on the basis of attendance at any educational institution or entity that admits as students only or predominantly members of one sex, if the giving of such preferences has the effect of discriminating on the basis of sex in violation of these Title IX regulations.
(b)
(1) Recruitment, advertising, and the process of application for employment;
(2) Hiring, upgrading, promotion, consideration for and award of tenure, demotion, transfer, layoff, termination, application of nepotism policies, right of return from layoff, and rehiring;
(3) Rates of pay or any other form of compensation, and changes in compensation;
(4) Job assignments, classifications, and structure, including position descriptions, lines of progression, and seniority lists;
(5) The terms of any collective bargaining agreement;
(6) Granting and return from leaves of absence, leave for pregnancy, childbirth, false pregnancy, termination of pregnancy, leave for persons of either sex to care for children or dependents, or any other leave;
(7) Fringe benefits available by virtue of employment, whether or not administered by the recipient;
(8) Selection and financial support for training, including apprenticeship, professional meetings, conferences, and other related activities, selection for tuition assistance, selection for sabbaticals and leaves of absence to pursue training;
(9) Employer-sponsored activities, including social or recreational programs; and
(10) Any other term, condition, or privilege of employment.
A recipient shall not administer or operate any test or other criterion for any employment opportunity that has a disproportionately adverse effect on persons on the basis of sex unless:
(a) Use of such test or other criterion is shown to predict validly successful performance in the position in question; and
(b) Alternative tests or criteria for such purpose, which do not have such disproportionately adverse effect, are shown to be unavailable.
(a)
(b)
A recipient shall not make or enforce any policy or practice that, on the basis of sex:
(a) Makes distinctions in rates of pay or other compensation;
(b) Results in the payment of wages to employees of one sex at a rate less than that paid to employees of the opposite sex for equal work on jobs the performance of which requires equal skill, effort, and responsibility, and that are performed under similar working conditions.
A recipient shall not:
(a) Classify a job as being for males or for females;
(b) Maintain or establish separate lines of progression, seniority lists, career ladders, or tenure systems based on sex; or
(c) Maintain or establish separate lines of progression, seniority systems, career ladders, or tenure systems for similar jobs, position descriptions, or job requirements that classify persons on the basis of sex, unless sex is a bona fide occupational qualification for the positions in question as set forth in § 5.550.
(a)
(b)
(1) Discriminate on the basis of sex with regard to making fringe benefits available to employees or make fringe benefits available to spouses, families, or dependents of employees differently upon the basis of the employee's sex;
(2) Administer, operate, offer, or participate in a fringe benefit plan that does not provide for equal periodic benefits for members of each sex and for equal contributions to the plan by such recipient for members of each sex; or
(3) Administer, operate, offer, or participate in a pension or retirement plan that establishes different optional or compulsory retirement ages based on sex or that otherwise discriminates in benefits on the basis of sex.
(a)
(1) Concerning the potential marital, parental, or family status of an employee or applicant for employment that treats persons differently on the basis of sex; or
(2) Which is based upon whether an employee or applicant for employment is the head of household or principal wage earner in such employee's or applicant's family unit.
(b)
(c)
(d)
(a)
(b)
A recipient shall not in any advertising related to employment indicate preference, limitation, specification, or discrimination based on sex unless sex is a bona fide occupational qualification for the particular job in question.
(a)
(b)
A recipient may take action otherwise prohibited by §§5.500 through 5.550 provided it is shown that sex is a bona fide occupational qualification for that action, such that consideration of sex with regard to such action is essential to successful operation of the employment function concerned. A recipient shall not take action pursuant to this section that is based upon alleged comparative employment characteristics or stereotyped characterizations of one or the other sex, or upon preference based on sex of the recipient, employees, students, or other persons, but nothing contained in this section shall prevent a recipient from considering an employee's sex in relation to employment in a locker room or toilet facility used only by members of one sex.
Within 60 days of September 29, 2000, each Federal agency that awards Federal financial assistance shall publish in the
The investigative, compliance, and enforcement procedural provisions of Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d) (“Title VI”) are hereby adopted and applied to these Title IX regulations. These procedures may be found at 10 CFR 4.21 through 4.75.
All recipients of Federal financial assistance from NRC are subject to Title IX,
(a)
(b)
(c)
(d)
(e)
Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); Pub. L. 92-463, 86 Stat. 770 (5 U.S.C. App.).
The regulations in this part define the policies and procedures to be followed by the Nuclear Regulatory Commission in the establishment, utilization, and termination of advisory committees. In general, it is the policy of the Commission that—
(a) Except where there is express legal authority to the contrary, the function of NRC advisory committees shall be advisory only.
(b) Each NRC advisory committee shall function in compliance with the Federal Advisory Commitee Act and this part.
(c) The number of NRC advisory committees shall be kept to the minimum necessary, and the number of members of each NRC advisory committee shall be limited to the fewest necessary to accomplish committee objectives.
(d) An NRC advisory committee shall be established only when establishment of the committee is required by law or when the Commission determines that the committee is essential to the conduct of NRC business. In making such a determination, the Commission shall consider whether committee deliberations will result in a significant contribution to the creation, amendment, or elimination of regulations, guidelines, or rules affecting NRC business; whether the information to be obtained is available through another source within the Federal Government; whether the committee will make recommendations resulting in significant improvements in service or reductions
(e) Except where otherwise required by law, an NRC advisory committee shall be terminated whenever the stated objectives of the committee have been accomplished, the subject matter or work of the committee has become obsolete, the committee's main functions have been assumed by another entity within the Federal Government, or the cost of operating the committee has become excessive in relation to the benefits accruing to the Federal Government from its activities.
(f) NRC advisory committees shall be balanced in their membership in terms of the points of view represented and the functions to be performed.
(g) The Congress shall be kept informed of the number, purpose, membership, activities, and cost of NRC advisory committees.
(h) NRC advisory committee meetings shall be open to the public, except where closure is determined to be justified under § 7.15.
At 67 FR 79838, Dec. 31, 2002, § 7.1 was amended by revising paragraph (d) and adding paragraphs (e)(1), (e)(2) and (i), effective Jan. 30, 2003. For the convenience of the user, the revised and added text is set forth as follows:
(d)(1) An NRC advisory committee shall be established only:
(i) When establishment of the committee is required by law;
(ii) When the Commission determines that the committee is essential to the conduct of NRC business; or
(iii) When the information to be obtained is not available through an existing advisory committee or a source within the Federal Government.
(2) Before establishing an advisory committee, the Commission shall consider whether:
(i) Committee deliberations will result in a significant contribution to the creation, amendment, or elimination of regulations, guidelines, or rules affecting NRC business;
(ii) The information to be obtained is available through another source within the Federal Government;
(iii) The committee will make recommendations resulting in significant improvements in service or reductions in cost; or
(iv) The committee's recommendations will provide an important additional perspective or viewpoint relating to NRC's mission. The advice or recommendations of an advisory committee should be the result of the advisory committee's independent judgment.
(e) * * *
(1) An advisory committee not required to be established by statute terminates no later than two years after its establishment or last renewal, unless renewed.
(2) An advisory committee required to be established by statute terminates upon the expiration of the time explicitly specified in the statute or implied by operation of the statute.
(i) The Commission may periodically invite feedback from the public regarding the effectiveness of NRC advisory committees.
As used in this part:
(1)
(2) For purposes of the definition of “advisory committee” in paragraph (1) of this definition, a group shall be considered to be “utilized by the President or any agency official to obtain advice or recommendations on issues or policies that fall within the scope of his or her responsibilities” if (i) the group is composed in whole or in part of other than full-time officers or employees of the Federal Government, (ii) the group has an established existence outside
(3) The following advisory meetings or groups are not included in the definition of “advisory committee” in paragraph (1) of this definition:
(i) Any group composed wholly of full-time officers or employees of the Federal Government;
(ii) Any group specifically exempted from the Act or these regulations by an Act of Congress;
(iii) Any local civic group whose primary function is that of rendering a public service with respect to a Federal program, or any State or local committee, council, board, commission, or similar group established to advise or make recommendations to any State or local government unit or an official thereof;
(iv) Any group that performs primarily operational functions specifically provided by law, as opposed to advisory functions;
(v) Any meeting initiated by the President or one or more Federal officials for the purpose of obtaining advice or recommendations from one individual;
(vi) Any meeting that is initiated by a Federal official and that is held with more than one individual for the purpose of obtaining the advice of individual attendees and not for the purpose of utilizing the group to obtain consensus advice or recommendations, except where the agency accepts the group's deliberations as a source of consensus advice or recommendations;
(vii) Any meeting initiated by a group with the President or one or more Federal officials for the purpose of expressing the group's view, provided that the President or Federal official does not use the group recurrently as a preferred source of advice or recommendations;
(viii) Any meeting of two or more advisory committee members convened solely to gather information or conduct research for a chartered advisory committee to analyze relevant issues and facts for a chartered advisory committee, or to draft proposed position papers for deliberation by a chartered advisory committee; and
(ix) Any meeting with a group initiated by the President or by one or more Federal officials for the purpose of exchanging facts or information.
At 67 FR 79839, Dec. 31, 2002, § 7.2 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(1) Any group composed wholly of full-time officers or employees of the Federal Government;
(2) Any group specifically exempted from the Act or these regulations by an Act of Congress;
(3) Any local civic group whose primary function is that of rendering a public service with respect to a Federal program, or any State or local committee, council, board, commission, or similar group established to advise or make recommendations to any State or local government unit or an official thereof;
(4) Any group that performs primarily operational functions specifically provided by law. Operational functions are those specifically authorized by statute or Presidential directive, such as making or implementing Government decisions or policy, as long as the group does not become primarily advisory in nature;
(5) Any meeting initiated by the President or one or more Federal employees for the purpose of obtaining advice or recommendations from one individual;
(6) Any meeting between an NRC employee with a non-governmental individual or group where advice or recommendations are provided by the attendees on an individual basis and are not sought from the group as a whole;
(7) Any meeting with a committee or group created by a non-Federal entity that is not managed or controlled by the President or a Federal employee;
(8) Any meeting of two or more advisory committee members convened solely to:
(i) Discuss administrative matters relating to the operation of their advisory committee;
(ii) Receive administrative information from a Federal employee;
(iii) Gather information or conduct research for a chartered advisory committee to analyze relevant issues and facts for their advisory committee; or
(iv) Draft proposed position papers for deliberation by their advisory committee;
(9) Any meeting with a group initiated by the President or by one or more Federal employees for the purpose of exchanging facts or information;
(10) Any meeting attended only by full-time or permanent part-time officers or employees of the Federal Government and elected officers of State, local, and tribal governments (or their designated employees with authority to act on their own behalf), acting in their official capacities. However, the purpose of the meeting must be solely to exchange views, information, or advice relating to the management or implementation of Federal programs established pursuant to statute, that explicitly or inherently share intergovernmental responsibilities or administration;
(11) Any meeting of an NRC contractor, applicant, or licensee with an NRC employee to discuss specific matters involving the solicitation, issuance, or implementation of a contract or the Commission's effort to ensure compliance with its regulations; and
(12) Any meeting of a subcommittee or other subgroup of an advisory committee where the subgroup's recommendations will be reviewed by its parent advisory committee.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by an NRC officer or employee, other than a written interpretation by the General Counsel, shall be binding upon the Commission.
(a) An NRC advisory committee may be established under this part only if its establishment—
(1) Is specifically directed or authorized by statute or by Executive Order of the President; or
(2) Has been determined by the Commission to be in the public interest and essential to the performance of the duties imposed on the Commission by law.
(a) Whenever the NRC proposes to establish or utilize an advisory committee, a letter requesting review of the proposal and transmitting a proposed charter for the committee shall be submitted to the GSA Secretariat by the Commission. The letter shall contain the following information:
(1) An explanation of why the committee is essential to the conduct of NRC business and is in the public interest;
(2) An explanation of why the committee's functions cannot be performed by NRC, another existing NRC advisory committee, or other means (such as a public hearing); and
(3) A description of NRC's plan to attain balanced membership on the committee.
(b) Each proposed committee charter submitted for review pursuant to paragraph (a) of this section shall contain the following information:
(1) The committee's official designation;
(2) The committee's objectives and the scope of its activity;
(3) The period of time necessary for the committee to carry out its purposes;
(4) The NRC official to whom the committee will report;
(5) The NRC office responsible for providing support for the committee;
(6) A description of the duties for which the committee will be responsible, and if such duties are not solely advisory, a specification of the authority for the functions that are not advisory;
(7) The estimated annual operating costs, in dollars and man-years, for the committee;
(8) The estimated number and frequency of committee meetings; and
(9) The committee's termination date, if less than two years from the date of the committee's establishment.
(c)(1) A subcommittee that does not function independently of its parent advisory committee shall be subject to the requirements of this part, except that it shall not be subject to the requirements of paragraphs (a) and (b) of this section. Such a subcommittee shall not, however, be subject to the requirements of this part with respect to any meeting of its members devoted solely to a function described in § 7.2(c)(3)(viii).
(2) The requirements of this part, including the requirements of paragraphs (a) and (b) of this section, shall apply to any subcommittee that functions independently of the parent advisory committee (such as by making recommendations directly to the agency rather than to the parent advisory committee), regardless of whether the subcommittee's members are drawn in whole or in part from the parent advisory committee.
(d) After the GSA Secretariat has notified the Commission of the results of its review of a proposal to establish or utilize an NRC advisory committee, submitted pursuant to paragraph (a) of this section, the Commission shall notify the GSA Secretariat in writing whether the advisory committee is actually being established. Filing of the advisory committee charter pursuant to § 7.8 shall be deemed to fulfill this notification requirement. If the advisory committee is not being established, the Commission shall so advise the GSA Secretariat in writing, stating whether NRC intends to take any further action with respect to the proposed advisory committee.
(e) The date of filing of an advisory committee charter pursuant to § 7.8 shall appear on the face of the charter and shall constitute the date of establishment, renewal, or reestablishment of the committee.
At 67 FR 79840, Dec. 31, 2002, § 7.5 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) Before establishing a discretionary advisory committee, the NRC shall consult with the Committee Management Secretariat. With a full understanding of the background and purpose behind the proposed advisory committee, the Committee Management Secretariat may share its knowledge and experience with the NRC on how best to make use of the proposed committee, alternate methods of attaining the agency's purpose, or whether a pre-existing advisory committee performs similar functions. Such consultation should include the transmittal of the proposed committee charter and the following information:
(1) A request for a review of the proposed charter;
(2) An explanation stating why the committee is essential to the conduct of NRC business and is in the public interest;
(3) An explanation stating why the committee's functions cannot be performed by the NRC, an existing NRC advisory committee, or other means (such as a public hearing); and
(4) A description of NRC's plan to attain balanced membership on the committee. The plan must ensure that, in the selection of members for the advisory committee, the NRC will consider a cross-section of those directly affected, interested, and qualified, as appropriate to the nature and functions of the committee. For purposes of attaining balance in an NRC advisory committee's membership, the Commission shall consider for membership interested persons and groups with professional, technical, or personal qualifications or experience that will contribute to the functions and tasks to be performed.
(b) Each proposed committee charter submitted for review pursuant to paragraph (a)
(1) The committee's official designation;
(2) The committee's objectives and the scope of its activity;
(3) The period of time necessary for the committee to carry out its purposes;
(4) The NRC official to whom the committee will report;
(5) The NRC office responsible for providing support for the committee;
(6) A description of the duties that the committee will perform, and if such duties are not solely advisory, a specification of the authority for the functions that are not advisory;
(7) The estimated annual operating costs, in dollars and person years, for the committee;
(8) The estimated number and frequency of committee meetings; and
(9) The committee's termination date, if less than two years from the date of the committee's establishment.
(c) The requirements of this part, including the requirements of paragraphs (a) and (b) of this section, shall apply to any subcommittee that functions independently of the parent advisory committee (such as by making recommendations directly to the agency rather than to the parent advisory committee), regardless of whether the subcommittee's members are drawn in whole or in part from the parent advisory committee.
(d) After the Committee Management Secretariat has notified the Commission of the results of its review of a proposal to establish or utilize an NRC discretionary advisory committee, submitted pursuant to paragraph (a) of this section, the Commission shall notify the Committee Management Secretariat whether the advisory committee is actually being established. Filing of the advisory committee charter pursuant to § 7.8 shall be deemed to fulfill this notification requirement. If the advisory committee is not being established, the Commission shall so advise the Committee Management Secretariat, stating whether NRC intends to take any further action with respect to the proposed advisory committee.
(e) The date of filing of an advisory committee charter pursuant to § 7.8 shall be added to the charter when such filing takes place, shall appear on the face of the charter, and shall constitute the date of establishment, renewal, or reestablishment of the committee.
(a) Final authority for amending the charter of an NRC advisory committee established or utilized by the NRC is vested in the Commission.
(b) Any proposed minor technical changes made to a current charter for an NRC advisory committee whose establishment is required or authorized by statute or by Executive Order of the President shall be coordinated with the General Counsel to ensure that they are consistent with the applicable statute or Executive Order. When the statute or Executive Order that directed or authorized the establishment of an advisory committee is amended to change the language that has been the basis for establishing the advisory committee, those sections of the current charter affected by the statute or Executive Order shall also be amended, and the amended charter shall be filed as specified in § 7.8.
(c)(1) The charter of an NRC advisory committee established under general agency authority may be amended when the Commission determines that the existing charter no longer reflects the objectives or functions of the committee. Such changes may be minor (such as revising the name of the advisory committee or modifying the estimated number or frequency of meetings), or they may be major (such as revising the objectives or composition of the committee). The procedures specified in paragraph (b) of this section shall be used in the case of charter amendments involving minor changes.
(2) In the case of a major amendment to the charter of an advisory committee established under general agency authority, a letter requesting review of the proposed amendment and transmitting the proposed amended charter shall be submitted to the GSA Secretariat. The letter shall explain the purpose of the changes and why they are necessary.
(3) A committee charter that has been amended pursuant to this paragraph is subject to the filing requirements set forth in § 7.8.
(4) Amendment of an existing advisory committee charter pursuant to this paragraph does not constitute renewal of the committee for purposes of § 7.7.
At 67 FR 79840, Dec. 31, 2002, § 7.6 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) Final authority for amending the charter of an NRC advisory committee established or utilized by the NRC is vested in the Commission.
(b) Any proposed changes made to a current charter for an NRC advisory committee shall be coordinated with the General Counsel to ensure that they are consistent with applicable legal requirements. When a statute or Executive Order that directed or authorized the establishment of an advisory committee is amended, those sections of the advisory committee's charter affected by the amendments shall also be amended.
(c)(1) The charter of an NRC advisory committee established under general agency authority may be amended when the Commission determines that the existing charter no longer reflects the objectives or functions of the committee. Such changes may be minor (such as revising the name of the advisory committee or modifying the estimated number or frequency of meetings), or they may be major (such as revising the objectives or composition of the committee).
(2) The procedures in paragraph (b) of this section shall be used in the case of charter amendments involving minor changes. A proposed major amendment to the charter of an advisory committee established under general agency authority shall be submitted to the Committee Management Secretariat for review with an explanation of the purpose of the changes and why they are necessary.
(3) A committee charter that has been amended pursuant to this paragraph is subject to the filing requirements set forth in § 7.8.
(4) Amendment of an existing advisory committee charter pursuant to this paragraph does not constitute renewal of the committee for purposes of § 7.7.
(a) Except as provided in paragraph (b)(1) of this section, each NRC advisory committee shall terminate two years after it is established, reestablished, or renewed, unless—
(1) It has been terminated sooner;
(2) It has been renewed or reestablished before the end of such period in accordance with the procedures set forth in paragraph (b) of this section; or
(3) Its duration has been otherwise designated by law.
The NRC Committee Management Officer shall notify the GSA Secretariat in writing of the effective date of termination of any advisory committee that has been terminated by the NRC.
(b)(1) An NRC advisory committee that is established by statute shall require rechartering by the filing of a new charter every 2 years after the date of enactment of the statute establishing the committee. If a new charter is not filed, the committee is not terminated, but it may not meet or take any actions.
(2) Any other NRC advisory committee may be renewed, provided that such renewal is carried out in compliance with the procedures set forth in § 7.5 at least 30 and not more than 60 days before the committee would otherwise terminate; except that an advisory committee established by the President may be renewed by appropriate action of the President and the filing of a new charter. Renewal of an NRC advisory committee shall not be deemed to terminate the appointment of any committee member who was previously appointed to serve on the committee.
At 67 FR 79840, Dec. 31, 2002, § 7.7 was amended by revising paragraphs (a)(3) and (b)(2), effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(3) Its duration has been otherwise designated by law. The NRC Committee Management Officer shall notify the Committee Management Secretariat of the effective date of termination of any advisory committee that has been terminated by the NRC.
(b) * * *
(2) Any other NRC advisory committee may be renewed, provided that such renewal is carried out in compliance with the procedures set forth in § 7.5, except that an advisory committee established by the President may be renewed by appropriate action of the President and the filing of a new charter. Renewal of an NRC advisory committee shall not be deemed to terminate the appointment of any committee member who was previously appointed to serve on the committee.
(a) Except as provided in paragraph (b) of this section, an NRC advisory committee may not operate, meet, or take any action unless a copy of the committee's charter has been filed
(b) When either the President or the Congress establishes an advisory committee that advises the President and for which NRC is responsible, the Commission shall—
(1) File the committee's charter with the GSA Secretariat;
(2) File a copy of the committee's charter with the Library of Congress at the address listed in paragraph (a) of this section; and
(3) If specifically directed by law, file with the Congressional Committees listed in paragraph (a) of this section a copy of the charter that shows its date of filing with the GSA Secretariat.
(c) For purposes of the filing requirements established by this section, the filing date of an advisory committee charter shall be the date on which the charter, or a copy of the charter where appropriate, is offered for filing at the office in which it is required to be filed (in the case of hand delivery), or on which it is deposited in the mail (in the case of delivery by mail).
(d) The charter filing requirements established by this section are subject to the public notice requirements of § 7.9.
At 67 FR 79841, Dec. 31, 2002, § 7.8 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
No advisory committee may meet or take any action until a charter has been filed by the Committee Management Officer designated in accordance with § 7.10.
(a) To establish, renew, or reestablish a discretionary advisory committee, a charter must be filed with:
(1) The Commission;
(2) The Committee on Environment and Public Works of the United States Senate and the Committee on Energy and Commerce of the United States House of Representatives;
(3) The Library of Congress, Anglo-American Acquisitions Division, Government Documents Section, Federal Advisory Committee Desk, 101 Independence Avenue, S.E., Washington, DC 20540-4172; and
(4) The Committee Management Secretariat, indicating the date the charter was filed with the congressional committees.
(b) Charter filing requirements for non-discretionary advisory committees are the same as those in paragraph (a) of this section, except the date of establishment for a Presidential advisory committee is the date the charter is filed with the Secretariat.
(c) Subcommittees that report directly to a Federal employee or agency must comply with this subpart.
(a) After the Commission has received the GSA Secretariat's response to a request (in accordance with § 7.5) for review of a proposal to establish, reestablish, renew, or utilize an NRC advisory committee, the Commission shall publish a notice in the
(b) Notices required to be published pursuant to paragraph (a) of this section shall be published at least 15 calendar days before the committee charter is filed pursuant to § 7.8, except that the GSA Secretariat may approve less than 15 days for good cause shown. The 15-day advance notice requirement does not apply to committee renewals, notices of which may be published concurrently with the filing of the charter.
At 67 FR 79841, Dec. 31, 2002, § 7.9 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) After the Commission has received notice from the Committee Management Secretariat that its review of a proposal to establish, reestablish, renew, or utilize an NRC discretionary advisory committee has been completed, the Commission shall publish a notice in the
(b) Notices required to be published pursuant to paragraph (a) of this section shall be published at least 15 calendar days before the committee charter is filed pursuant to § 7.8, except that the Committee Management Secretariat may approve publication for less than 15 days for good cause shown. The 15-day advance notice requirement does not apply to advisory committee renewals, notices of which may be published concurrently with the filing of the charter.
(a) The Chairman of the Commission shall appoint an NRC Advisory Committee Management Officer to carry out the functions specified in paragraph (b) of this section.
(b) The NRC Advisory Committee Management Officer shall—
(1) Carry out all responsibilities relating to NRC advisory committees delegated to such officer by the Commission;
(2) Ensure that administrative guidelines and management controls are issued that apply to all NRC advisory committees;
(3) Exercise control and supervision over the establishment, procedures, and accomplishments of NRC advisory committees;
(4) Assemble and maintain the reports, records, and other papers of any such committee during this existence;
(5) Carry out, on behalf of NRC, the provisions of the Freedom of Information Act (5 U.S.C. 552) and NRC's Freedom of Information Act Regulations (10 CFR part 9, subpart A) with respect to such reports, records, and other papers;
(6) Ensure that, subject to the Freedom of Information Act and NRC's Freedom of Information Act regulations at 10 CFR part 9, subpart A, copies of the records, reports, transcript minutes, appendices, working papers, drafts, studies, agenda, or other documents that were made available to or prepared for or by each NRC advisory committee are available for public inspection and copying at the NRC Web site
(7) Ensure that, subject to the Freedom of Information Act and NRC's Freedom of Information Act Regulations, at least eight copies of each report made by each NRC advisory committee and, where appropriate, background papers prepared by consultants, shall be filed with the Library of Congress;
(8) Ensure that NRC keeps such records as will fully disclose the disposition of any funds that may be at the disposal of NRC advisory committees and the nature and extent of their activities; and
(9) Ensure that NRC keeps such other records and provides such support services as are required by § 7.22.
(c) For purposes of paragraph (b) of this section, the term “records” includes (but is not limited to):
(1) A set of approved charters and membership lists for each NRC advisory committee;
(2) Copies of NRC's portion of the President's annual report to the Congress on Federal advisory committees required by section 6(c) of the Act;
(3) NRC guidelines on committee management operations and procedures as maintained and updated; and
(4) NRC determinations to close advisory committee meetings made pursuant to § 7.15.
At 67 FR 79841, Dec. 31, 2002, § 7.10 was amended by revising paragraphs (a), (b)(5), (b)(6), (b)(7) and (c)(2), effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) The Chairman of the Commission or designee shall appoint an NRC Advisory Committee Management Officer to carry out
(b) * * *
(5) Carry out, on behalf of the NRC, the provisions of the Freedom of Information Act (5 U.S.C. 552) and implementing NRC regulations (10 CFR part 9, subpart A) with respect to such reports, records, and other papers;
(6) Ensure that, subject to the Freedom of Information Act and implementing NRC regulations at 10 CFR part 9, subpart A, copies of the records, reports, transcript minutes, appendices, working papers, drafts, studies, agenda, or other documents that were made available to or prepared for or by each NRC advisory committee are available for public inspection and copying at the NRC Web site,
(7) Ensure that, subject to the Freedom of Information Act and implementing NRC regulations, at least eight copies of each report made by each NRC advisory committee and, where appropriate, background papers prepared by consultants, shall be filed with the Library of Congress;
(c) * * *
(2) Copies of NRC's portion of the Committee Management Secretariat Annual Comprehensive Review of Federal advisory committees required by section 7(b) of the Act;
(a) The Chairman of the Commission shall appoint a Designated Federal Officer for each NRC advisory committee and its subcommittees. The individual holding this position must be employed by the Federal Government on either a full-time or a permanent part-time basis.
(b) All meetings of an NRC advisory committee must be convened or approved by the committee's Designated Federal Officer, and the agenda for each committee meeting (except a meeting of a Presidential advisory committee) must be approved by that individual.
(c) An NRC advisory committee may not hold a meeting in the absence of its Designated Federal Officer.
(d) It shall also be the responsibility of the Designated Federal Officer to—
(1) Attend all meetings of the committee for which he or she has been appointed;
(2) Adjourn the meetings of the committee when such adjournment is in the public interest;
(3) Chair the meetings of the committee when so directed by the Commission;
(4) Ensure compliance with the requirements of § 7.13 regarding minutes of meetings of the committee; and
(5) Make copies of committee documents required to be maintained for public inspection and copying pursuant to § 7.14(b) available at the NRC Web site,
At 67 FR 79841, Dec. 31, 2002, § 7.11 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) The Chairman of the Commission or designee shall appoint a Designated Federal Officer or alternate Designated Federal Officer for each NRC advisory committee. The individual holding either position must be employed by the Federal Government on either a full-time or a permanent part-time basis.
(b) All meetings of an NRC advisory committee must be convened or approved by the committee's Designated Federal Officer or alternate, and the agenda for each committee meeting (except a meeting of a Presidential advisory committee) must be approved by that individual.
(c) An NRC advisory committee may not hold a meeting in the absence of its Designated Federal Officer or alternate.
(d) It shall also be the responsibility of the Designated Federal Officer or alternate to:
(1) Attend all meetings of the committee for which he or she has been appointed;
(2) Adjourn the meetings of the committee when such adjournment is in the public interest;
(3) Chair the meetings of the committee when so directed by the Commission;
(4) Ensure compliance with the requirements of § 7.13 regarding minutes of meetings of the committee; and
(5) Make copies of committee documents required to be maintained for public inspection and copying pursuant to § 7.14(b) and ensure their availability at the NRC Web site,
(a) Each meeting of an NRC advisory committee shall be held at a reasonable time and in a place reasonably accessible to the public. The size of the meeting room must be sufficient to accommodate advisory committee members, committee or agency staff, and interested members of the public; except that, the provisions of this paragraph shall not apply where an entire NRC advisory committee meeting has been closed pursuant to § 7.15.
(b) Any member of the public who wishes to do so shall be permitted to file a written statement with an NRC advisory committee regarding any matter discussed at a meeting of the committee. The committee chairman may also permit members of the public to speak at meetings of the committee in accordance with procedures established by the committee.
(c) Except when the President or his designee determines in writing that no notice should be published for reasons of national security, at least 15 days prior to an NRC advisory committee meeting, a notice that includes the following information shall be published in the
(1) The exact name of the advisory committee as chartered;
(2) The time, date, place, and purpose of the meeting;
(3) A summary of the agenda of the meeting; and
(4) Whether all or part of the meeting is open to the public.
(d) In exceptional circumstances, less than 15 days notice of an advisory committee meeting may be given, provided that there is as much prior notice as possible and the reasons for the shorter time are included in the committee meeting notice published in the
(e) In addition to notice required by paragraph (c) of this section, the NRC may also use other forms of notice, such as public releases and notice by mail, to inform the public of advisory committee meetings. To that end, the Designated Federal Officer of each NRC advisory committee will, to the extent practicable, maintain lists of people and organizations interested in that advisory committee and notify them of meetings by mail.
At 67 FR 79841, Dec. 31, 2002, § 7.12 was amended by revising paragraphs (a), (c), and (e) and by adding paragraph (f), effective Jan. 30, 2003. For the convenience of the user, the revised and added text is set forth as follows:
(a) Each meeting of an NRC advisory committee shall be held at a reasonable time and in a place reasonably accessible to the public, including persons with disabilities. Any advisory committee meeting conducted in whole or part by teleconference, video conference, the Internet, or other electronic medium must comply with this section. The size of the meeting room must be sufficient to accommodate advisory committee members, committee or agency staff, and interested members of the public, except that the provisions of this paragraph relating to the room size shall not apply to any part of an NRC advisory committee meeting that has been closed pursuant to § 7.15.
(c)(1) Except when the President or designee determines in writing that no notice should be published for reasons of national security, at least 15 days prior to an NRC advisory committee meeting, a notice that includes the following information shall be published in the
(i) The exact name of the advisory committee as chartered;
(ii) The time, date, place, and purpose of the meeting;
(iii) A summary of the agenda of the meeting;
(iv) Whether all or part of the meeting is open to the public; and
(v) The name and telephone number of the Designated Federal Officer, alternate, or other responsible agency employee who may be contacted for additional information concerning the meeting.
(2) If any part of the meeting is closed, the notice shall provide the reasons for the closure, citing the specific matter that has been determined to justify the closure under § 7.15. The Commission may publish a single notice announcing multiple meetings; however, a meeting may not be announced so far in advance as to prevent the public from being
(e) In addition to notice required by paragraph (c) of this section, the NRC may also use other forms of notice, such as press releases, posting the information on the NRC Web site,
(f) Meetings of a subcommittee whose recommendations will not be reviewed by its parent advisory committee shall be conducted in accordance with all notice and openness requirements contained in this section and in §§ 7.13, 7.14, and 7.15.
(a) Detailed minutes shall be kept of each NRC advisory committee meeting. The minutes shall include the following information:
(1) The time, date, and place of the meeting;
(2) A list of the attendees at the meeting who are advisory committee members or staff, agency employees, or members of the public who presented oral or written statements;
(3) An estimate of the number of other members of the public who were present;
(4) The extent of public participation; and
(5) An accurate description of each matter discussed during the meeting and its resolution, if any, by the committee.
(b) The minutes of an NRC advisory committee meeting shall include a copy of each report or other document received, issued, or approved by the committee in connection with the meeting. If it is impracticable to attach a document to the minutes, the minutes shall describe the document in sufficient detail to permit it to be identified readily.
(c) The chairperson of an NRC advisory committee shall certify to the accuracy of the minutes of each of the committee's meetings. In the case of a subgroup of an advisory committee, the chairperson of the subgroup shall certify to the accuracy of the minutes.
(d) A verbatim transcript of an advisory committee meeting may be substituted for minutes required by this section, providing that the use of such a transcript is in accordance with the requirements of paragraphs (a), (b), and (c) of this section.
At 67 FR 79842, Dec. 31, 2002, § 7.13 was amended by revising paragraph (c), effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(c) The chairperson of an NRC advisory committee shall certify the accuracy of the minutes of each of the committee's meetings.
(a) The Nuclear Regulatory Commission shall maintain systematic information on the nature, functions, and operations of each NRC advisory committee. A complete set of the charters of NRC advisory committees and copies of the annual reports required by § 7.17(a) will be maintained for public inspection at either the NRC Web site,
(b) Subject to the provisions of the Freedom of Information Act (5 U.S.C. 552) and NRC's Freedom of Information Act regulations at 10 CFR part 9, subpart A, copies of NRC advisory committees’ records, reports, transcripts, minutes, appendices, working papers, drafts, studies, agenda, and other documents shall be maintained for public inspection and copying at the NRC Web site,
At 67 FR 79842, Dec. 31, 2002, § 14 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) The Nuclear Regulatory Commission shall maintain systematic information on the nature, functions, and operations of each NRC advisory committee. A complete set of the charters of NRC advisory committees and copies of the annual reports required by § 7.17(a) will be maintained for public inspection at either the NRC Web site,
(b) Subject to the provisions of the Freedom of Information Act (5 U.S.C. 552) and NRC's Freedom of Information Act regulations at 10 CFR part 9, subpart A, copies of NRC advisory committees' records, reports, transcripts, minutes, appendices, working papers, drafts, studies, agenda, and other documents shall be maintained for public inspection and copying at the NRC Web site,
(c) Official records generated by or for an advisory committee must be retained for the duration of the advisory committee. Upon termination of the advisory committee, the records must be processed in accordance with the Federal Records Act (44 U.S.C. Chapters 21, 29-33) and regulations issued by the National Archives and Records Administration (
(a) To close all or part of a meeting of an NRC advisory committee, the committee shall submit a written request for closure to the Chairman of the Commission, citing specific matter listed in the Government in the Sunshine Act (5 U.S.C. 552b), as implemented by 10 CFR 9.104, to justify the closure. The request shall provide the Chairman sufficient time for review in order to make a determination prior to publication of the meeting notice pursuant to § 7.12.
(b) The General Counsel shall review all requests to close meetings of NRC advisory committees.
(c) If the Chairman of the Commission agrees that the request is consistent with the policies of this part, a determination shall be issued in writing that all or part of the meeting will be closed. The determination shall include a statement of the reasons for the closing.
(d) Except when the President or his designee determines in writing that no notice should be published for reasons of national security, the Chairman of the Commission shall make a copy of the determination to close all or part of an NRC advisory committee meeting available to the public upon request, and shall state the reasons why all or part of the meeting is closed, citing the specific matter listed in the Government in the Sunshine Act (as implemented by 10 CFR 9.104) in the meeting notice published in the
(e) The Chairman of the Commission may delegate the Chairman's functions under paragraphs (c) and (d) of this section to such officer of the Commission as the Chairman considers appropriate. The General Counsel shall review any determination to close a meeting made by a delegate.
At 67 FR 79842, Dec. 31, 2002, § 7.15 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) To close all or part of a meeting of an NRC advisory committee, the committee shall submit a written request for closure to the General Counsel, citing specific exemptions listed in the Government in the Sunshine Act (5 U.S.C. 552b), as implemented by 10 CFR 9.104, that justify the closure. The request shall provide the General Counsel sufficient time for review in order to make a determination prior to publication of the meeting notice pursuant to § 7.12.
(b) If the General Counsel finds that the request for closure is consistent with the provisions of the Government in the Sunshine Act and this part, a determination shall be issued in writing that all or part of the meeting will be closed. The determination shall include a statement of the reasons for the closing, citing the applicable exemptions in the Government in the Sunshine Act (as implemented by 10 CFR 9.104).
(c) Except when the President or designee determines in writing that no notice should be published for reasons of national security, the Secretary of the Commission shall make a copy of the determination to close all or part of an NRC advisory committee meeting
(a) The Chairman of the Commission shall conduct an annual comprehensive review of the activities and responsibilities of each NRC advisory committee to determine whether the committee—
(1) Is carrying out its purposes or, consistent with the provisions of applicable statutes, its responsibilities should be revised.
(2) Should be merged with another advisory committee.
(3) Should be terminated.
(b) The comprehensive review required by paragraph (a) of this section shall include consideration of such information regarding the committee as is required for the Commission's annual report to the GSA Secretariat pursuant to § 7.27(a) and such other information as may be requested from the Committee by the NRC Advisory Committee Management Officer. The results of such review shall be included in the annual report to the GSA Secretariat.
(c) If, as a result of the review required by this section, the Commission determines that an advisory committee is no longer needed, the committee shall be terminated; except that in the case of an advisory committee established by an Act of Congress or the President, the committee's termination shall be recommended to the President or the Congress, as the case may be.
At 67 FR 79842, Dec. 31, 2002, § 7.16 was amended in paragraph (b) by removing the reference to “7.27(a)” and adding, in its place, a reference to “7.17(a)”, effective Jan. 30, 2003.
(a) The Commission shall furnish a report on the activities of NRC advisory committees annually to the Administrator and the GSA Secretariat on a fiscal year basis. The report must contain information regarding NRC advisory committees required by Section 6(c) of the Act for the President's annual report to the Congress and be consistent with instructions provided by the GSA Secretariat. A copy of the report is made available at the NRC Web site,
(b) Any NRC advisory committee holding closed meetings shall issue a report, at least annually, setting forth a summary of its activities consistent with the policy of the Government in the Sunshine Act (5 U.S.C. 552b), as implemented by 10 CFR 9.104. A copy of the report is made available at the NRC Web site,
(c) Subject to the Freedom of Information Act (5 U.S.C. 552) and NRC's Freedom of Information Act Regulations (10 CFR part 9, subpart A), eight copies of each report made by an advisory committee, including any report on closed meetings pursuant to paragraph (b) of this section, and, where appropriate, background papers prepared by consultants, shall be filed for public inspection and use with the Library of Congress, Exchange and Gift Division, Federal Documents Section, Federal Advisory Committee Desk, Washington, DC 20540.
At 67 FR 79842, Dec. 31, 2002, § 7.17 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) The Commission shall furnish a report on the activities of NRC advisory committees annually to the Committee Management Secretariat on a fiscal year basis. The report must contain information regarding NRC advisory committees consistent with instructions provided by the Committee Management Secretariat. A copy of the report shall be made available at the NRC Web site,
(b) Any NRC advisory committee holding closed or partially closed meetings shall issue a report, at least annually, setting forth a summary of its activities consistent with the policy of the Government in the Sunshine Act (5 U.S.C. 552b), as implemented by 10 CFR 9.104. A copy of the report shall be
(c) Subject to the Freedom of Information Act (5 U.S.C. 552) and implementing NRC regulations (10 CFR part 9, subpart A), eight copies of each report made by an advisory committee, including any report on closed meetings pursuant to paragraph (b) of this section, and, where appropriate, background papers prepared by consultants, shall be filed for public inspection and use with the Library of Congress, Anglo-American Acquisitions Division, Government Documents Section, Federal Advisory Committee Desk, 101 Independence Avenue, SE., Washington, DC 20540-4172.
(a) Except where otherwise provided by law, the Commission may accept the gratuitous services of an NRC advisory committee member, staff member, or consultant who agrees in advance to serve without compensation.
(b)(1) Subject to the provisions of paragraph (b)(2) of this section, if the Commission determines that compensation of a member of an NRC advisory committee is appropriate, the amount that will be paid shall be fixed by the Chairman of the Commission at a rate that is the daily equivalent of a rate of NRC's General Salary Schedule, unless the member is appointed as a consultant and compensated at a rate applicable to NRC consultants. (See NRC Manual for NRC's General Salary Schedule and rates applicable to NRC consultants.)
(2) In determining an appropriate rate of pay for a member of an NRC advisory committee, the Chairman of the Commission shall give consideration to the significance, scope, and technical complexity of the matters with which the advisory committee is concerned and the qualifications required of the committee member; provided that the Chairman may not set the rate of pay for an NRC advisory committee member higher than the daily equivalent of the maximum rate for a GG-15 under NRC's General Salary Schedule, unless a higher rate is mandated by statute or the Commission itself has determined that a higher rate is justified and necessary. The Commission may not delegate the responsibility for making a determination that such a higher rate of pay is necessary and justified for an NRC advisory committee member, and such a determination must be reviewed annually.
(3) An advisory committee member may not be paid at a rate higher than the daily equivalent of the maximum rate for a GG-18 under NRC's General Salary Schedule.
(c)(1) Each NRC advisory committee staff member may be paid at a rate that is the daily equivalent of a rate of NRC's General Salary Schedule in which the staff member's position would appropriately be placed.
(2) A staff member of an NRC advisory committee may not be paid at a rate higher than the daily equivalent of the maximum rate for a GG-15 under NRC's General Salary Schedule, unless the Chairman of the Commission determines that the staff member's position would appropriately be placed at a grade higher than GG-15; provided that in establishing rates of compensation, the Chairman shall comply with any applicable statutes, regulations, Executive Orders, and administrative guidelines.
(3) A determination to set the rate of pay of a staff position at a grade higher than GG-15 under the NRC's General Salary Schedule rate of pay shall be reviewed annually by the Chairman of the Commission.
(4) A Federal employee may serve as a staff member of an NRC advisory committee only with the knowledge of the Designated Federal Officer for the committee and the approval of the employee's direct supervisor. A staff member who is not otherwise a Federal employee shall be appointed in accordance with applicable agency procedures, following consultation with the advisory committee.
(d) The following factors shall be considered in determining an appropriate rate of pay for a consultant to an NRC advisory committee:
(1) The qualifications required of the consultant, and
(2) The significance, scope, and technical complexity of the work for which his services are required;
(e) A member or staff member of an NRC advisory committee engaged in the performance of duties away from his or her home or regular place of business may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703, title 5, United States Code, for persons employed intermittently in the Government service.
(f) Nothing in this section shall—
(1) Prevent any full-time Federal employee who provides services to an NRC advisory committee from receiving compensation at a rate at which he or she would otherwise be compensated as a full-time Federal employee.
(2) Prevent any individual who provides services to an NRC advisory committee, and who immediately before providing such services was a full-time Federal employee, from receiving compensation at a rate at which he or she was compensated as a full-time Federal employee.
(3) Affect a rate of pay or a limitation on a rate of pay that is specifically established by law or a rate of pay established under the NRC's General Salary Schedule and evaluation system (see NRC Manual).
At 67 FR 79843, Dec. 31, 2002, § 7.18 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
(a) Unless otherwise provided by law, advisory committee members serve at the pleasure of the Commission and their terms are at the sole discretion of the Commission.
(b) Except where otherwise provided by law, the Commission may accept the gratuitous services of an NRC advisory committee member, staff member, or consultant who agrees in advance to serve without compensation.
(c)(1) Subject to the provisions of paragraph (c)(2) of this section, if the Commission determines that compensation of a member of an NRC advisory committee is appropriate, the amount that will be paid shall be fixed by the Chairman of the Commission at a rate that is the daily equivalent of a rate in NRC's General Grade Salary Schedule, unless the member is appointed as a consultant and compensated at a rate applicable to NRC consultants.
(2) In determining an appropriate rate of pay for a member of an NRC advisory committee, the Chairman of the Commission shall give consideration to the significance, scope, and technical complexity of the matters with which the advisory committee is concerned and the qualifications required of the committee member; provided that the Chairman may not set the rate of pay for an NRC advisory committee member higher than the daily equivalent rate for level IV of the Executive Schedule under 5 U.S.C. 5315, unless a higher rate is expressly allowed by another statute. The Chairman may authorize a rate of basic pay in excess of the maximum rate of basic pay established for NRC's General Grade Salary Schedule. This maximum rate includes an applicable locality payment. The Commission may pay advisory committee members on either an hourly or a daily rate basis. The Commission may not provide additional compensation in any form, such as bonuses or premium pay. The Chairman may not delegate the responsibility for making a determination that a higher rate of pay than that established by NRC's General Grade Salary Schedule is necessary and justified for an NRC advisory committee member, and such a determination must be reviewed annually.
(d)(1) Each NRC advisory committee staff member may be paid at a rate that is the daily equivalent of a rate in NRC's General Grade Salary Schedule in which the staff member's position would appropriately be placed.
(2) A staff member of an NRC advisory committee may not be paid at a rate higher than the daily equivalent of the maximum rate for a GG-15 under NRC's General Grade Salary Schedule, unless the Chairman of the Commission determines that the staff member's position would appropriately be placed at a grade higher than GG-15, provided that in establishing rates of compensation, the Chairman shall comply with any applicable statutes, regulations, Executive Orders, and administrative guidelines. The Commission may provide advisory committee staff members with additional compensation, such as bonuses or premium pay, as long as the aggregate compensation does not exceed the rate of pay for Executive Schedule level IV.
(3) A Federal employee may serve as a staff member of an NRC advisory committee only with the knowledge of the advisory committee's Designated Federal Officer or alternate and the approval of the employee's direct supervisor. A staff member who is not otherwise a Federal employee shall be appointed in accordance with applicable agency procedures, following consultation with the advisory committee.
(e)(1) Subject to the limitations in paragraph (e)(2) of this section, the following factors shall be considered in determining an appropriate rate of pay for a consultant to an NRC advisory committee:
(i) The qualifications required of the consultant, and
(ii) The significance, scope, and technical complexity of the work for which his services are required;
(2) The rate of pay for an NRC advisory committee consultant may not be higher than the maximum rate of basic pay established by NRC's General Salary Schedule (that is, the GG-15, step 10 rate, excluding locality pay or any other supplement), unless a higher rate is expressly allowed by another statute. The appointment and compensation of NRC experts and consultants must be in conformance with applicable regulations issued by the United States Office of Personnel Management (see 5 CFR part 304).
(f) A member or staff member of an NRC advisory committee engaged in the performance of duties away from his or her home or regular place of business may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703, title 5, United States Code, for persons employed intermittently in the Government service.
(g) Nothing in this section shall:
(1) Prevent any full-time Federal employee who provides services to an NRC advisory committee from receiving compensation at a rate at which he or she would otherwise be compensated as a full-time Federal employee;
(2) Prevent any individual who provides services to an NRC advisory committee, and who immediately before providing such services was a full-time Federal employee, from receiving compensation at a rate at which he or she was compensated as a full-time Federal employee; or
(3) Affect a rate of pay or a limitation on a rate of pay that is specifically established by law or a rate of pay established under the NRC's General Grade Salary Schedule and evaluation system.
An NRC advisory committee member who is blind or deaf or otherwise handicapped may be provided services by a personal assistant for handicapped employees while performing advisory committee duties, if the member—
(a) Qualifies as a handicapped individual as defined by section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 794); and
(b) Does not otherwise qualify for assistance under 5 U.S.C. 3102 by reason of being an employee of NRC.
At 67 FR 79843, Dec. 31, 2002, § 7.19 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
An NRC advisory committee member who is disabled may be provided services by a personal assistant while performing advisory committee duties, if the member;
(a) Qualifies as disabled under section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 794) ; and
(b) Does not otherwise qualify for assistance under 5 U.S.C. 3102 by reason of being an employee of NRC.
The Designated Federal Officer of each NRC advisory committee and the General Counsel shall review the interests and affiliations of each member of the Designated Federal Officer's advisory committee annually, and upon the commencement and termination of the member's appointment to the committee, for the purpose of ensuring that such appointment is consistent with the laws and regulations on conflict of interest applicable to that member.
At 67 FR 79843, Dec. 31, 2002, § 7.20 was revised, effective Jan. 30, 2003. For the convenience of the user, the revised text is set forth as follows:
The Designated Federal Officer or alternate for each NRC advisory committee and the General Counsel or designee shall review the interests and affiliations of each member of the Designated Federal Officer's advisory committee annually, and upon the commencement of the member's appointment to the committee, for the purpose of ensuring that such appointment is consistent with the laws and regulations on conflict of interest applicable to that member.
Copies of the records, reports, transcripts, minutes, appendices, working papers, drafts, studies, agenda, or other documents that were made available to
(a) The Office of the Chief Financial Officer shall keep such records as will fully disclose the disposition of any funds that may be at the disposal of NRC advisory committees.
(b) The Office of the Chief Information Officer shall keep such records as will fully disclose the nature and extent of activities of NRC advisory committees.
(c) NRC shall provide support services (including staff support and meeting space) for each advisory committee established by or reporting to it unless the establishing authority provides otherwise. Where any such advisory committee reports to another agency in addition to NRC, only one agency shall be responsible for support services at any one time, and the establishing authority shall designate the agency responsible for providing such services.
Secs. 152, 161, 68 Stat. 944, 948, as amended; 42 U.S.C. 2182, 2201.
(a) Inquiries have been received as to the applicability of the provisions of section 152 of the Atomic Energy Act of 1954 (68 Stat. 944) to inventions or discoveries made or conceived in the course of activities under licenses issued by the Atomic Energy Commission.
(b) In my [General Counsel, U.S. Atomic Energy Commission] opinion a license issued by the Atomic Energy Commission is not a “contract, subcontract, arrangement or other relationship with the Commission” as those terms are used in section 152 of the act. Hence, the mere fact that an invention or discovery is made by a licensee in the course of activities authorized by a license would not give the Commission rights under section 152 with respect to such invention or discovery. On the other hand, if a licensee has entered into a “contract,subcontract, arrangement or other relationship with the Commission,” inventions or discoveries made or conceived by the licensee under the contract or other relationship would come within the purview of section 152.
(c) As used in this section, “license” means a license issued pursuant to Chapter 6 (Special Nuclear Material), 7 (Source Material), 8 (Byproduct Material) or 10 (Atomic Energy Licenses) of the Atomic Energy Act of 1954, or a construction permit issued pursuant to section 185 of the act.
(a) It is my opinion that an indemnity agreement entered into by the Atomic Energy Commission under the authority of the Atomic Energy Act of 1954 (42 U.S.C. 2011,
(b) Section 170 authorizes the Commission to indemnify against “public liability” as defined in section 11(u) of
(c) In the case of damage outside of the United States caused by a nuclear facility based in the United States there would be a “nuclear incident” as defined in section 11(o) since there would be an “occurrence within the United States causing * * * damage.”
(d) Similarly, the requirement of “legal liability” would be met. The words of the Act impose no limitation that the liability be one for damage caused in the United States but, on the contrary, are exceedingly broad permitting indemnification for “any legal liability.” In the most exhaustive study of the subject, it is stated that the phrase “any legal liability” indicates that liability for damage outside the United States is covered by the Act. Atomic Industrial Forum, Financial Protection Against Atomic Hazards 61 n. 355 (1957).
(e) Thus the precise language of the Act provides coverage for damage ensuing both within and without the United States arising out of an occurrence within the United States. There would be no occasion for doubt were it not for a single statement contained in the Report of the Joint Committee on Atomic Energy on the Price-Anderson Act. The Report states, at p. 16 that “[i]f there is anything from a nuclear incident at the licensed activity which causes injury abroad, or if there is any activity abroad which causes further injury in the United States the situation will require further investigation at that time.” This sentence follows an explicit and lengthy statement that the “occurrence” is an event at the site of the activity:
* * * The occurrence which is the subject of this definition is that event at the site of the licensed activity, or activity for which the Commission has entered into a contract, which may cause damage, rather than the site where the damage may perhaps be caused. This site must be within the United States. The suggested exclusion of facilities under license for export was not accepted. This is because the definition of “nuclear incident” limits the occurrence causing damage to one within the United States. It does not matter what license may be applicable if the occurrence is within the United States. If there is anything from a nuclear incident at the licensed activity which causes injury abroad or if there is any activity abroad
(f) The point in question received scant consideration during the hearings preceding adoption of the bill held by the Joint Committee on Atomic Energy. A summary of the study of the Atomic Industrial Forum, cited above, was introduced into the record of the hearing and included a conclusion that the provisions of the bill seemed to cover the situation.
(g) There was also a rather ambiguous colloquy in the hearings between Representative Cole and Mr. Charles Haugh in which Representative Cole indicated that the Joint Committee
(h) Congress, in enacting the Price-Anderson Indemnity Act added to section 2 of the Atomic Energy Act of 1954, a new subsection which stated, inter alia:
In order * * * to encourage the development of the atomic energy industry, * * * the United States may make funds available for a portion of the damages suffered by the public from nuclear incidents and may limit the liability of those persons liable for such losses.
(i) It is my opinion that since the language of the Act draws no distinction between damage received in the United States and that received abroad, none can properly be drawn. To read the Act as imposing such a limitation in the absence of statutory direction and in the light of an avowed Congressional intention to encourage the development of the atomic energy industry would be unwarranted. The confusing sentence cited in the Report must, therefore, be read consistently with the language of the Act in the manner suggested above, i.e., as recognizing Congressional inability to limit foreign liability, or must be ignored as inconsistent with the broad coverage of the statutory language.
(a) By virtue of the Atomic Energy Act of 1954, as amended,
(b) The Atomic Energy Act of 1954 sets out a pattern for licensing and regulation of certain nuclear materials and facilities on the basis of the common defense and security and radiological health and safety. The regulatory pattern requires, in general, that the construction and operation of production facilities (nuclear reactors used for production and separation of plutonium or uranium-233 or fuel reprocessing plants) and utilization facilities (nuclear reactors used for production of power, medical therapy, research, and testing) and the possession and use of byproduct material (radioisotopes), source material (thorium and uranium ores), and special nuclear material (enriched uranium and plutonium, used as fuel in nuclear reactors), be licensed and regulated by the Commission.
(c) The Atomic Energy Act of 1954 had the effect of preempting to the Federal Government the field of regulation of nuclear facilities and byproduct, source, and special nuclear material. Whatever doubts may have existed as to that preemption were settled by the passage of the Federal-State amendment to the Atomic Energy Act of 1954 in 1959.
(d) Prior to 1954, all nuclear facilities and the special nuclear material produced by or used in them were owned by the AEC.
(e) Section 274 (42 U.S.C. 2021) authorizes the Commission to enter into an agreement with the Governor of any State providing for the discontinuance of regulatory authority of the Commission with respect to byproduct materials, source materials, and special nuclear materials in quantities not sufficient to form a “critical mass.” However, section 274c (42 U.S.C. 2021(c)) provides that the Commission shall retain authority and responsibility with respect to the regulation of:
(1) The construction and operation of production or utilization facilities (note: this includes construction and operation of nuclear power plants);
(2) The export and import of by-product, source or special nuclear material or production or utilization facilities;
(3) The disposal into the ocean of waste byproduct, source or special nuclear materials; and
(4) The disposal of such other byproduct, source or special nuclear material as the Commission determines should, because of the hazards or potential hazards thereof, not be so disposed of without a Commission license.
(f) The amendment, in providing for the discontinuance of some of the AEC's regulatory authority over source, by-product and special nuclear material in States which entered into agreements with the AEC, made clear that there should be no “dual regulation” with respect to those materials for the purpose of protection of the public health and safety from radiation hazards.
(g) Section 274b of the Atomic Energy Act (42 U.S.C. 2021(b)) states that:
During the duration of such an agreement it is recognized that the State shall have authority to regulate the materials covered by the agreement for the protection of the public health and safety from radiation hazards.
Nothing in this section shall be construed to affect the authority of any State or local agency to regulate activities for purposes other than protection against radiation hazards.
(h) In its comments on the bill that was enacted as section 274, the Joint Committee on Atomic Energy commented that:
It is not intended to leave any room for the exercise of dual or concurrent jurisdiction by States to control radiation hazards by regulating byproduct, source, or special nuclear materials. The intent is to have the material regulated and licensed either by the Commission, or by the State and local governments, but not by both.
As indicated elsewhere, the Commission has exclusive authority to regulate for protection against radiation hazards until such
(i) It seems completely clear that the Congress, in enacting section 274, intended to preempt to the Federal Government the total responsibility and authority for regulating, from the standpoint of radiological health and safety, the specified nuclear facilities and materials; that it stated that intent unequivocally; and that the enactment of section 274 effectively carried out the Congressional intent, subject to the arrangement for limited relinquishment of AEC's regulatory authority and assumption thereof by states in areas permitted, and subject to conditions imposed, by section 274.
(j) Thus, under the pattern of the Atomic Energy Act, as amended by section 274, States which have not entered into a section 274 agreement with the AEC are without authority to license or regulate, from the standpoint of radiological health and safety, byproduct, source, and special nuclear material or production and utilization facilities. Even those States which have entered into a section 274 agreement with the AEC (Agreement States) lack authority to license or regulate, from the standpoint of radiological health and safety, the construction and operation of production and utilization facilities (including nuclear power plants) and other activities reserved to the AEC by section 274c. (To the extent that Agreement States have authority to regulate byproduct, source, and special nuclear material, their section 274 Agreements require them to use their best efforts to assure that their regulatory programs for protection against radiation hazards will continue to be compatible with the AEC's program for the regulation of byproduct, source and special nuclear material.)
(k) The following judicial precedents and legal authorities support the foregoing conclusions: Northern California Ass'n, Etc. v. Public Utilities Commission, 37 Cal. Rep. 432, 390 P. 2d 200 (1964); Boswell v. City of Long Beach, CCH Atomic Energy Law Reports, par. 4045 (1960); Opinion of the Attorney General of Michigan (Oct. 31, 1962); Opinion of the Attorney General of South Dakota (July 23, 1964); New York State Bar Association, Committee on Atomic Energy, State Jurisdiction to Regulate Atomic Activities (July 12, 1963). No precedents or authorities to the contrary have come to our attention.
(a) A request has been received to interpret 10 CFR 73.55(c)(5) and 73.55(d)(1).
Isolation zones and all exterior areas within the protected area shall be provided with illumination sufficient for the monitoring and observation requirements of paragraphs (c)(3), (c)(4), and (h)(4) of this section, but not less than 02. footcandle measured horizontally at ground level.
(b) The requester contends that the regulation is satisfied if 0.2 footcandle is provided only at the protected area boundary and the isolation zone. The language of the regulation is clearly to the contrary. It requires not less than 0.2 footcandle for “all exterior areas within the protected area.” This regulation helps effectuate the monitoring and observation requirements of 10 CFR 73.55. For example, 10 CFR 73.55(c)(4) states that “All exterior areas within the protected area shall be periodically checked to detect the presence of unauthorized persons, vehicles, or materials.” In the absence of illumination, such checking could not be fully effective.
(c) The requester also asks whether the illumination requirement extends
(d) 10 CFR 73.55(d)(1) provides in pertinent part: The search function for detection of firearms, explosives, and incendiary devices shall be conducted either by a physical search or by use of equipment capable of detecting such devices.
(e) The requester contends that until “equipment capable of detecting such devices” is in place, a licensee need not comply with the search requirement, but can utilize instead previous security programs. This contention is based on the first sentence of 10 CFR 73.55 which provides in pertinent part that the requirements of paragraph (d) of that section shall be met by May 25, 1977, “except for any requirement involving construction and installation of equipment not already in place expressed in (paragraph)(d)(1) * * * ” Under this sentence only those requirements of paragraph (d) which involve “construction and installation of equipment” do not take effect on May 25, 1977. Because a “physical search” does not require “constuction and installation of equipment”, implementation of such searches is required on May 25, 1977. The regulation provides alternative: “the search function * * * shall be conducted either by a physical search or by use of equipment * * *.” Thus when appropriate equipment is in place, the search function need not involve a physical search.
(f) The paragraphs above set forth interpretation of regulations; they do not apply those regulations to particular factual settings. For example, no effort is made to state what lighting system might be used for a given facility; all that is stated is that a system must provide not less than 0.2 footcandle for all exterior areas within the protected area. Similarly, no effort is made to define what is an adequate “physical search”; all that is stated is that, in the absence of appropriate equipment, such searches must begin on May 25, 1977.
Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
Subpart A also issued under 5 U.S.C. 552; 31 U.S.C. 9701; Pub. L. 99-570.
Subpart B is also issued under 5 U.S.C. 552a.
Subpart C also issued under 5 U.S.C. 552b.
(a) Subpart A implements the provisions of the Freedom of Information Act, 5 U.S.C. 552, concerning the availability to the public of Nuclear Regulatory Commission records for inspection and copying.
(b) Subpart B implements the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, concerning disclosure and availability of certain Nuclear Regulatory Commission records maintained on individuals.
(c) Subpart C implements the provisions of the Government in the Sunshine Act, 5 U.S.C. 552b, concerning the opening of Commission meetings to public observation.
(d) Subpart D describes procedures governing the production of agency records, information, or testimony in response to subpoenas or demands of courts or other judicial or quasi-judicial authorities in State and Federal proceedings.
As used in this part:
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by an officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized as binding upon the Commission.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0043.
(b) The approved information collection requirements contained in this part appear in §§ 9.23, 9.29, 9.40, 9.41, 9.53, 9.54, 9.55, 9.65, 9.66, and 9.67.
This subpart prescribes procedures for making NRC agency records available to the public for inspection and copying pursuant to the provisions of the Freedom of Information Act (5 U.S.C. 552) and provides notice of procedures for obtaining NRC records otherwise publicly available. This subpart does not affect the dissemination or distribution of NRC-originated, or NRC contractor-originated, information to the public under any other NRC public, technical, or other information program or policy.
(1) Publicly-available books, periodicals, or other publications that are owned or copyrighted by non-Federal sources;
(2) Records solely in the possession and control of NRC contractors;
(3) Personal records in possession of NRC personnel that have not been circulated, were not required to be created or retained by the NRC, and can be retained or discarded at the author's sole discretion, or records of a personal nature that are not associated with any Government business; or
(4) Non-substantive information in logs or schedule books of the Chairman or Commissioners, uncirculated except for typing or recording purposes.
(1) The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;
(2) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records demanded in a single request; or
(3) The need for consultation, which will be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request or among two or more components of the NRC having substantial subject-matter interest therein.
The NRC will make available for public inspection and copying any reasonably described agency record in the possession and control of the NRC under the provisions of this subpart, and upon request by any person. Records will be made available in any form or format requested by a person if the record is readily reproducible by NRC in that form or format. NRC will make reasonable efforts to maintain its records in forms or formats that are reproducible. NRC will make reasonable efforts to search for records in
(a) The following types of agency records are exempt from public disclosure under § 9.15:
(1) Records—
(i) That are specifically authorized under criteria established by an Executive Order to be kept secret in the interest of national defense or foreign policy, and
(ii) That are in fact properly classified pursuant to such Executive Order;
(2) Records related solely to the internal personnel rules and practices of the agency;
(3) Records specifically exempted from disclosure by statute (other than 5 U.S.C. 552b), provided that the statute—
(i) Requires that the matters be withheld from the public in a manner that leaves no discretion on the issue; or
(ii) Establishes particular criteria for withholding or refers to particular types of matters to be withheld;
(4) Trade secrets and commercial or financial information obtained from a person that are privileged or confidential;
(5) Interagency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency;
(6) Personnel and medical files and similar files, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
(7) Records or information compiled for law enforcement purposes, but only to the extent that the production of these law enforcement records or information—
(i) Could reasonably be expected to interfere with enforcement proceedings;
(ii) Would deprive a person of a right to a fair trial or an impartial adjudication;
(iii) Could reasonably be expected to constitute an unwarranted invasion of personal privacy;
(iv) Could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority, or any private institution which furnished information on a confidential basis, and, in the case of a record or information compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, or information furnished by a confidential source;
(v) Would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions, if the disclosure could reasonably be expected to risk circumvention of the law; or
(vi) Could reasonably be expected to endanger the life or physical safety of any individual;
(8) Matters contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of any agency responsible for the regulation or supervision of financial institutions; or
(9) Geological and geophysical information and data, including maps, concerning wells.
(b) Nothing in this subpart authorizes withholding of information or limiting the availability of records to the public except as specifically provided in this part, nor is this subpart authority to withhold information from Congress.
(c) Whenever a request is made that involves access to agency records described in paragraph (a)(7) of this section, the NRC may, during only the time as that circumstance continues, treat the records as not subject to the requirements of this subpart when—
(1) The investigation or proceeding involves a possible violation of criminal law; and
(2) There is reason to believe that—
(i) The subject of the investigation or proceeding is not aware of its pendency; and
(ii) Disclosure of the existence of the records could reasonably be expected to interfere with enforcement proceedings.
(a) For records required to be made available under 5 U.S.C. 552(a)(2), the NRC shall delete information that is exempt under one or more of the exemptions cited in § 9.17. The amount of information deleted will be indicated on the released portion of the record, unless providing this indication would harm an interest protected by the exemption(s) under which the matter has been withheld.
(b) In responding to a request for information submitted under § 9.23, in which it has been determined to withhold exempt information, the NRC shall segregate—
(1) Information that is exempt from public disclosure under § 9.17(a) from nonexempt information; and
(2) Factual information from advice, opinions, and recommendations in predecisional records unless the information is inextricably intertwined, or is contained in drafts, legal work products, and records covered by the lawyer-client privilege, or is otherwise exempt from disclosure.
(c) In denying a request for records, in whole or in part, NRC will make a reasonable effort to estimate the volume of any information requested that is denied and provide the estimate to the person making the request, unless providing the estimate would harm an interest protected by the exemption(s) under which the information has been denied.
(d) When entire records or portions thereof are denied and deletions are made from parts of the record by computer, the amount of information deleted will be indicated on the released portion of the record, unless providing this indication would harm an interest protected by the exemption(s) under which the matter has been denied.
(a) Single copies of NRC publications in the NUREG series, NRC Regulatory Guides, and Standard Review Plans can be ordered from the National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia, 22161.
(b) For the convenience of persons who may wish to inspect without charge, or purchase copies of a record or a limited category of records for a fee, publicly available records of the NRC's activities described in paragraph (c) of this section are also made available at the NRC Web site,
(c) The following records of NRC activities are available for public inspection and copying:
(1) Final opinions including concurring and dissenting opinions as well as orders of the NRC issued as a result of adjudication of cases;
(2) Statements of policy and interpretations that have been adopted by the NRC and have not been published in the
(3) Nuclear Regulatory Commission rules and regulations;
(4) Nuclear Regulatory Commission Manuals and instructions to NRC personnel that affect any member of the public;
(5) Copies of records that have been released to a person under the Freedom of Information Act that, because of the nature of their subject matter, the NRC determines have become or are likely to become the subject of subsequent requests for substantially the same records.
(6) A general index of the records released under the FOIA.
(d) The published versions of the records made publicly available under paragraph (c)(1) of this section are available under the title, Nuclear Regulatory Issuances, NUREG-0750, for purchase through the National Technical Information Service.
(a)(1) A person may request access to records routinely made available by the NRC under § 9.21 in person, by telephone, by e-mail, facsimile, or U.S. mail from the NRC Public Document Room, One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland 20852-2738.
(i) Each record requested must be described in sufficient detail to enable the NRC Public Document Room staff to locate the record.
(ii) In order to obtain copies of records expeditiously, a person may open an account at the NRC Public Document Room with the private contracting firm that is responsible for duplicating NRC records.
(2) [Reserved]
(b) A person may request agency records by submitting a request authorized by 5 U.S.C. 552(a)(3) to the Freedom of Information Act and Privacy Act Officer, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The request must be in writing and clearly state on the envelope and in the letter that it is a “Freedom of Information Act request.” The NRC does not consider a request as received until it has been received and logged in by the office of the Freedom of Information Act and Privacy Act Officer.
(1) A Freedom of Information Act request covers only agency records that are in existence on the date the Freedom of Information Act and Privacy Act Officer receives the request. A request does not cover agency records destroyed or discarded before receipt of a request or which are created after the date of the request.
(2) All Freedom of Information Act requests for copies of agency records must reasonably describe the agency records sought in sufficient detail to permit the NRC to identify the requested agency records. Where possible, the requester should provide specific information regarding dates, titles, docket numbers, file designations, and other information which may help identify the agency records. If a requested agency record is not described in sufficient detail to permit its identification, the Freedom of Information Act and Privacy Act Officer will contact the requester within 10 working days after receipt of the request and inform the requester of the additional information or clarification needed to process the request.
(3) Upon receipt of a request made under paragraph (b) of this section, the NRC will provide written notification to the requester that indicates the request has been received, the name and telephone number of the NRC point of contact to find out the status of the request, and other pertinent matters regarding the processing of the request.
(4)(i) The NRC shall advise a requester that fees will be assessed if—
(A) A request involves anticipated costs in excess of the minimum specified in § 9.39; and
(B) Search and duplication is not provided without charge under § 9.39; or
(C) The requester does not specifically state that the cost involved is acceptable or acceptable up to a specified limit.
(ii) The NRC has discretion to discontinue processing a request made under this paragraph until—
(A) A required advance payment has been received;
(B) The requester has agreed to bear the estimated costs;
(C) A determination has been made on a request for waiver or reduction of fees; or
(D) The requester meets the requirements of § 9.39.
(c) If a requested agency record that has been reasonably described is located at a place other than at the NRC Web site,
(d) Except as provided in § 9.39—
(1) If the record requested under paragraph (b) of this section is a record available through the National Technical Information Service, the NRC shall refer the requester to the National Technical Information Service; and
(2) If the requested record has been placed on the NRC Internet Web site, under § 9.21, the NRC may inform the requester that the record is available at the NRC Web site,
(e) The Freedom of Information Act and Privacy Act Officer will promptly forward a Freedom of Information Act request made under paragraph (b) of this section for an agency record to the head of the office(s) primarily concerned with the records requested, as appropriate. The responsible office will conduct a search for the agency records responsive to the request and compile those agency records to be reviewed for initial disclosure determination and/or identify those that have already been made publicly available at the NRC Web site,
(a)
(b)
(1) The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;
(2) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or
(3) The need for consultation, which will be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request or among two or more components of the NRC having substantial subject-matter interest therein.
(c)
(d)
(1) NRC uses a three-track system.
(i) The first track is for requests of simple to moderate complexity that are expected to be completed within 20 working days.
(ii) The second track is for requests involving “unusual circumstances” that are expected to take between 21-30 working days to complete (e.g. requests involving possible records from two or three offices and/or various types of files of moderate volume, of which, some are expected to be exempt)
(iii) The third track is for requests that, because of their unusual volume or other complexity, are expected to take more than 30 working days to complete (e.g. requests involving several offices, regional offices, another
(2) Upon receipt of requests, NRC will notify requesters of the track in which the request has been placed for processing and the estimated time for completion. Should subsequent information substantially change the estimated time to process a request, the requester will be notified telephonically or in writing. A requester may modify the request to allow it to be processed faster or to reduce the cost of processing. Partial responses may be sent to requesters as documents are obtained by the FOIA office from the supplying offices.
(e)
(i) That a failure to obtain requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or
(ii) With respect to a request made by a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal Government activity.
(2) A person requesting expedited processing must include a statement certifying the compelling need given to be true and correct to the best of his or her knowledge and belief. The certification requirement may be waived by the NRC as a matter of agency discretion.
(3) The Freedom of Information Act and Privacy Act Officer will make the initial determination whether to grant or deny a request for expedited processing and will notify a requester within 10 calendar days after the request has been received whether expedited processing will be granted.
(f)
(g)
(h)
(i)
(j) If the NRC does not respond to a request within the 20 working-day period, or within the extended periods described in paragraph (b) of this section, the requester may treat that delay as a denial of the request and immediately appeal as provided in § 9.29(a) or sue in a Federal District Court as noted in § 9.29(c).
(a) When the NRC has located a requested agency record and has determined to disclose the agency record, the Freedom of Information Act and Privacy Act Officer will promptly furnish the agency record or notify the requester where and when the agency record will be available for inspection and copying. The NRC will also advise the requester of any applicable fees under §§ 9.35 and 9.37. The NRC will routinely place copies of non-sensitive agency records disclosed in response to Freedom of Information Act requests in the NRC Public Document Room and on microfiche in Local Public Document Rooms. Records will not be routinely placed in the NRC Public Document Room and Local Public Document Rooms that contain information personal to the requester, involve matters that are not likely to be of public interest to anyone other than the requester or contain privileged or proprietary information that should only be disclosed to the requester.
(b) When the NRC denies access to a requested agency record or denies a request for expedited processing or for a waiver or reduction of fees, the Freedom of Information Act and Privacy Act Officer will notify the requester in writing. The denial will include as appropriate—
(1) The reason for the denial;
(2) A reference to the specific exemption under the Freedom of Information Act, or other appropriate reason, and the Commission's regulations authorizing the denial;
(3) The name and title or position of each person responsible for the denial of the request, including the head of the office recommending denial of the record;
(4) A statement stating why the request does not meet the requirements of § 9.41 if the request is for a waiver or reduction of fees; and
(5) A statement that the denial may be appealed within 30 calendar days from the date of the denial to the Executive Director for Operations, to the Secretary of the Commission, or to the Inspector General, as appropriate.
(c) The Freedom of Information Act and Privacy Act Officer will maintain a copy of each letter granting or denying requested agency records, denying a request for expedited processing, or denying a request for a waiver or reduction
(a) A requester may appeal a notice of denial of a Freedom of Information Act request for access to agency records, denial of a request for waiver or reduction of fees, or denial of a request for expedited processing under this subpart within 30 calendar days of the date of the NRC's denial. For agency records denied by an Office Director reporting to the Executive Director for Operations, the appeal must be in writing and addressed to the Executive Director for Operations, U.S. Nuclear Regulatory Commission, Washington, DC 20555. For agency records denied by an Office Director reporting to the Commission, the Assistant Secretary of the Commission, or the Advisory Committee Management Officer and for a denial of a request for a waiver or reduction of fees, or denial of a request for expedited processing, the appeal must be in writing and addressed to the Secretary of the Commission. For agency records denied by the Assistant Inspector General for Investigations, the appeal must be in writing and addressed to the Inspector General. The appeal should clearly state on the envelope and in the letter that it is an “Appeal from Initial FOIA Decision.” The NRC does not consider an appeal that is not marked as indicated in this paragraph as received until it is actually received by the Executive Director for Operations, Secretary of the Commission, or the Inspector General.
(b) The NRC will make a determination on any appeal made under this section within 20 working days after the receipt of the appeal, except an appeal of the denial of a request for expedited processing will be determined within 10 working days after receipt of the appeal.
(c)(1) If the appeal is denied in whole or in part, the Executive Director for Operations or a Deputy Director, the Secretary of the Commission, or the Inspector General, as appropriate, will notify the requester of the denial, explaining the exemptions relied upon and how the exemptions apply to the agency records withheld.
(2) If, on appeal, the denial of a request for expedited processing or for a waiver or reduction of fees for locating and reproducing agency records is upheld in whole or in part, the Secretary of the Commission will notify the person making the request of the decision to sustain the denial, including a statement explaining why the request does not meet the requirements of § 9.25(e) (1) and (2) or § 9.41.
(3) The Executive Director for Operations, or a Deputy Executive Director, or the Secretary of the Commission, or the Inspector General will inform the requester that the denial is a final agency action and that judicial review is available in a district court of the United States in the district in which the requester resides or has a principal place of business, in which the agency records are situated, or in the District of Columbia.
(d) The Executive Director for Operations, or a Deputy Executive Director, or the Secretary of the Commission, or the Inspector General will furnish copies of all appeals and written determinations on appeals to the Freedom of Information Act and Privacy Act Officer.
(a) In unusual circumstances defined in § 9.13, the NRC may extend the time limits prescribed in § 9.25 or § 9.29 by not more than 10 working days. The extension may be made by written notice to the person making the request to explain the reasons for the extension and indicate the date on which a determination is expected to be dispatched.
(b) An extension of the time limits prescribed in §§ 9.25 and 9.29 may not exceed a combined total of 10 working days per request, unless a requester has agreed to an alternative time frame as described in § 9.25 (c).
(a) The NRC charges fees for—
(1) Search, duplication, and review, when agency records are requested for commercial use;
(2) Duplication of agency records provided in excess of 100 pages when agency records are not sought for commercial use and the request is made by an educational or noncommercial scientific institution, or a representative of the news media;
(3) Search time that exceeds two hours and duplication of agency records of more than 100 pages for requests from all other categories of requesters not described in paragraphs (a)(1) and (a)(2) of this section;
(4) The direct costs of searching for agency records. The NRC will assess fees even when no agency records are located as a result of the search or when agency records that are located as a result of the search are not disclosed; and
(5) Computer searches which includes the cost of operating the Central Processing Unit for the portion of operating time that is directly attributable to searching for agency records plus the operator/programmer salary apportionable to the search.
(b) The NRC may charge requesters who request the following services for the direct costs of the service:
(1) Certifying that records are true copies;
(2) Sending records by special methods, such as express mail, package delivery service, courier, and other means other than first class mail; or
(3) Producing or converting records to formats specified by a requester other than ordinary copying processes that are readily available in NRC.
(a) The NRC will assess interest on the fee amount billed starting on the 31st day following the day on which the billing was sent in accordance with NRC's regulations set out in § 15.37 of this chapter. The rate of interest is prescribed in 31 U.S.C. 3717.
(b) The NRC will use its debt collection procedures under part 15 of this chapter for any overdue fees.
(a)(1) The charges by the duplicating service contractor for the duplication of records made available under § 9.21 at the NRC Public Document Room (PDR), One White Flint North, 11555 Rockville Pike, Room O-1F23, Rockville, MD are as follows:
(i) Paper-to-paper reproduction is $0.15 per page for standard size (up to 11′ × 14′). Pages 11′ × 17′ are $0.30 per page. Pages larger than 11′ × 17′, including engineering drawings, are $2.50 per square foot.
(ii) Color drawings are $2.00 per 8
(iii) Microfiche-to-paper reproduction is $0.15 per page. Aperture cards are $2.50 per square foot.
(iv) The charges for Electronic Full Text (EFT) (ADAMS documents) copying are as follows:
(A) Electronic Full Text (EFT) copying of ADAMS documents to paper (applies to images, OCR TIFF, and PDF text) is $0.15 per page.
(B) Electronic Full Text (EFT) copying of ADAMS documents to CD-ROM is $10.00 for the first document on the CD-ROM and $5.00 for each additional document per accession number on the same CD-ROM.
(C) CD-ROM-to-paper reproduction is $0.15 per page.
(v) Priority rates (rush processing) are as follows:
(A) The priority rate is offered for standard size paper-to-paper reproduction, microfiche-to-paper reproduction, electronic full text (EFT) copying of ADAMS documents to paper, and CD-ROM-to-paper production at $0.20 per page. The priority rate for standard size color prints is $2.50 per print. The priority rate for color drawings larger than 8
(B) The priority rate for aperture cards is $3.50 per square foot. The priority rate for electronic full text (EFT) to CD-ROM is $15.00 for the first document on the CD-ROM and $7.50 per each additional document on the same CD-ROM.
(vi) Facsimile charges are $0.30 per page for local calls; $0.50 per page for U.S. long distance calls, and $1.00 per page for foreign long distance calls.
(2) Self-service duplicating machines are available at the NRC Public Document Room for the use of the public. Paper to paper copy is $0.08 per page. Microfiche to paper is $0.10 per page on the reader printers.
(3) A requester may submit mail-order requests for contractor duplication of NRC records made by writing to the NRC Public Document Room. The charges for mail-order duplication of records are the same as those set out in paragraph (a)(1) of this section, plus mailing or shipping charges.
(4) A requester may open an account with the duplicating service contractor. A requester may obtain the name and address and billing policy of the contractor from the NRC Public Document Room.
(5) Any change in the costs specified in this section will become effective immediately pending completion of the final rulemaking that amends this section to reflect the new charges. The Commission will post the charges that will be in effect for the interim period at the NRC Public Document Room. The Commission will publish a final rule in the
(b) The NRC will assess the following charges for copies of records to be duplicated by the NRC at locations other than the NRC Public Document Room located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland.
(1) Sizes up to 8
(2) The charge for duplicating records other than those specified in paragraphs (a) and (b) of this section is computed on the basis of NRC's direct costs.
(c) In compliance with the Federal Advisory Committee Act, a requester may purchase copies of transcripts of testimony in NRC Advisory Committee proceedings, which are transcribed by a reporting firm under contract with the NRC directly from the reporting firm at the cost of reproduction as provided for in the contract with the reporting firm. A requester may also purchase transcripts from the NRC at the cost of reproduction as set out in paragraphs (a) and (b) of this section.
(d) Copyrighted material may not be reproduced in violation of the copyright laws. As such, requesters will be given the citation to any copyrighted documents and a copy of the material will be placed in the Public Document Room where it may be viewed by requesters.
The NRC will charge the following hourly rates for search and review of agency records by NRC personnel:
(a) Clerical search and review at a salary rate that is equivalent to a GG-7/step 7, plus 16 percent fringe benefits;
(b) Professional/managerial search and review at a salary rate that is equivalent to a GG-13/step 6, plus 16 percent fringe benefits; and
(c) Senior executive or Commissioner search and review at a salary rate that is equivalent to an ES-4, plus 16 percent fringe benefits.
(a) The NRC will search for agency records requested under § 9.23(b) without charges when agency records are not sought for commercial use and the records are requested by an educational or noncommercial scientific institution, or a representative of the news media.
(b) The NRC will search for agency records requested under § 9.23(b) without charges for the first two hours of search for any request not sought for commercial use and not covered in paragraph (a) of this section.
(c) The NRC will duplicate agency records requested under § 9.23(b) without charge for the first 100 pages of standard paper copies, or the equivalent cost of 100 pages of standard paper copies when providing the requester copies in microfiche or electronic form such as computer disks, if the requester is not a commercial use requester.
(d) The NRC may not bill any requester for fees if the cost of collecting the fee would be equal to or greater than the fee itself.
(e) The NRC may aggregate requests in determining search and duplication to be provided without charge as provided in paragraphs (a) and (b) of this
(a) If the request is expected to require the NRC to assess fees in excess of $25 for search and/or duplication, the NRC will notify the requester that fees will be assessed unless the requester has indicated in advance his or her willingness to pay fees as high as estimated.
(b) In the notification, the NRC will include the estimated cost of search fees and the nature of the search required and estimated cost of duplicating fees.
(c) The NRC will encourage requesters to discuss with the NRC the possibility of narrowing the scope of the request with the goal of reducing the cost while retaining the requester's original objective.
(d) If the fee is determined to be in excess of $250, the NRC will require an advance payment.
(e) Unless a requester has agreed to pay the estimated fees or, as provided for in paragraph (d) of this section, the requester has paid an estimated fee in excess of $250, the NRC may not begin to process the request.
(f) If the NRC receives a new request and determines that the requester has failed to pay a fee charged within 30 calendar days of receipt of the bill on a previous request, the NRC may refuse to accept the new request for processing until payment is made of the full amount owed on the prior request, plus any applicable interest assessed as provided in § 9.34.
(g) Within 10 working days of the receipt of NRC's notice that fees will be assessed, the requester will provide advance payment if required, notify the NRC in writing that the requester agrees to bear the estimated costs, or submit a request for a waiver or reduction of fees pursuant to § 9.41.
(a)(1) The NRC will collect fees for searching for, reviewing, and duplicating agency records, except as provided in § 9.39, unless a requester submits a request in writing for a waiver or reduction of fees. To ensure that there will be no delay in the processing of Freedom of Information Act requests, the request for a waiver or reduction of fees should be included in the initial Freedom of Information Act request letter.
(2) Each request for a waiver or reduction of fees must be addressed to the Freedom of Information Act and Privacy Act Officer, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
(b) A person requesting the NRC to waive or reduce search, review, or duplication fees will—
(1) Describe the purpose for which the requester intends to use the requested information;
(2) Explain the extent to which the requester will extract and analyze the substantive content of the agency record;
(3) Describe the nature of the specific activity or research in which the agency records will be used and the specific qualifications the requester possesses to utilize information for the intended use in such a way that it will contribute to public understanding;
(4) Describe the likely impact on the public's understanding of the subject as compared to the level of public understanding of the subject before disclosure;
(5) Describe the size and nature of the public to whose understanding a contribution will be made;
(6) Describe the intended means of dissemination to the general public;
(7) Indicate if public access to information will be provided free of charge or provided for an access fee or publication fee; and
(8) Describe any commercial or private interest the requester or any other party has in the agency records sought.
(c) The NRC will waive or reduce fees, without further specific information from the requester if, from information provided with the request for agency records made under § 9.23(b), it can determine that disclosure of the information in the agency records is in
(d) In making a determination regarding a request for a waiver or reduction of fees, the NRC will consider the following factors:
(1) How the subject of the requested agency records concerns the operations or activities of the Federal Government;
(2) How the disclosure of the information is likely to contribute significantly to public understanding of Federal Government operations or activities;
(3) The extent to which, the requester has a commercial interest that would be furthered by the disclosure of the requested agency records; and whether that commercial interest exceeds the public interest in disclosure.
(e) The Freedom of Information Act and Privacy Act Officer will make an initial determination whether a request for a waiver or reduction of fees meets the requirements of this section. The Freedom of Information Act and Privacy Act Officer will inform requesters whenever their request for a waiver or reduction of fees is denied and will inform them of their appeal rights under § 9.29.
(a) Within 20 working days after receipt of a request for access to agency records for which the NRC agrees to waive fees under § 9.39 (a) through (d) or § 9.41(c), the NRC will respond to the request as provided in § 9.25.
(b) In making a request for a waiver or reduction of fees, a requester shall provide the information required by § 9.41(b).
(c) After receipt of a request for the waiver or reduction of fees made in accordance with § 9.41, the NRC will either waive or reduce the fees and notify the requester of the NRC's intent to provide the agency records promptly or deny the request and provide a statement to the requester explaining why the request does not meet the requirements of § 9.41(b).
(d) As provided in § 9.29, a requester may appeal a denial of a request to waive or reduce fees to the Secretary to the Commission. The appeal must be submitted within 30 calendar days from the date of the notice.
(a) On or before February 1 of each year, the NRC will submit a report covering the preceding fiscal year to the Attorney General of the United States which shall include—
(1) The number of determinations made by the NRC to deny requests for records made to the NRC under this part and the reasons for each determination;
(2) The number of appeals made by persons under § 9.29, the results of the appeals, and the reason for the action taken on each appeal that results in a denial of information;
(3) A complete list of all statutes that the NRC relied upon to withhold information under subsection (b)(3) of 5 U.S.C. 552, a description of whether a court has upheld the decision of the NRC to withhold information under each such statute, and a concise description of the scope of any information withheld;
(4) The number of requests for records pending before the NRC as of September 30 of the preceding year, and the median number of days that such requests had been pending before the agency as of that date;
(5) The number of requests for records received by the NRC and the number of requests that the NRC processed;
(6) The median number of days taken to process different types of requests;
(7) The total amount of fees collected by the NRC for processing requests;
(8) The number of full-time staff of the NRC devoted to processing requests under the FOIA and the total amount expended for processing these requests.
(b) The NRC will make a copy of the most recent report available to the public at the NRC Web site,
This subpart implements the provisions of section 3 of the Privacy Act of 1974, Pub. L. 93-579, 5 U.S.C. 552a, with respect to (a) the procedures by which individuals may determine the existence of, seek access to and request correction of NRC records concerning themselves, and (b) the requirements applicable to NRC personnel with respect to the use and dissemination of such records. The regulations in this subpart apply to all records which are retrievable from a system of records under the control of the Nuclear Regulatory Commission by the use of an individual's name or of an identifying number, symbol, or other identifying particular assigned to such individual. Except where specifically provided otherwise, this subpart applies to all NRC records maintained on individuals whether they predate or postdate September 27, 1975.
As used in this subpart:
(a)
(b) The term
(c)
(d)
(e)
(f)
(g)
(a) Individuals may make the following requests respecting records about themselves maintained by NRC in a system of records subject to the provisions of the Privacy Act of 1974:
(1) Request a determination whether a record about the individual is contained in a system of records.
(2) Request access to a record about the individual. Access requests may include requests to review the record and to have a copy made of all or any portion thereof in a form comprehensible to the individual.
(3) Request correction or amendment of a record about the individual.
(b)
(a) Requests may be made in person or in writing. Assistance regarding requests or other matters relating to the Privacy Act of 1974 may be obtained by writing to the Freedom of Information Act and Privacy Act Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Requests relating to records in multiple systems of records should be made to the Freedom of Information Act and Privacy Act and Privacy Act Officer, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The Freedom of Information Act and Privacy Act Officer shall assist the requestor in identifying his request more precisely and shall be responsible for forwarding the request to the appropriate system manager.
(b) All written requests shall be made to the Freedom of Information Act and Privacy Act Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and should clearly state on the envelope and in the letter, as appropriate: “Privacy Act Request,” “Privacy Act Disclosure Accounting Request,” “Privacy Act Correction Request.” A request that is not so marked will be deemed not to have been received by the NRC until it is actually received by the Freedom of Information Act and Privacy Act Officer.
(c) Requests may be made in person during official hours at the U.S. Nuclear Regulatory Commission office where the record is located, as listed in the “Notice of System of Records” for the system in which the record is contained.
(a) Identification requirements in paragraphs (a) (1) and (2) of this section are applicable to any individual who makes requests respecting records about himself, except that no verification of identity shall be required if the records requested are available to the public under the provisions of the Freedom of Information Act. With respect to certain sensitive records, additional requirements for verification of identity stated in the appropriate published “Notice of System of Records” may be imposed.
(1)
(2)
(b)
(c)
(a)(1) Requests relating to records shall, insofar as practicable, specify the nature of the record sought, the approximate dates covered by the record, the system of records in which the record is thought to be included and the system manager having custody of the record system as shown in the annual compilation, “Notices of Records Systems”, published by the General Services Administration. Requests shall, in addition, comply with any additional specification requirements contained in the published “Notice of System of Records” for that system.
(2) Requests for correction or amendment of records shall, in addition, specify the particular record involved, state the nature of the correction or amendment sought and furnish justification for the correction or amendment.
(b) Requests which do not contain information sufficient to identify the record requested will be returned promptly to the requestor, with a notice indicating what information is lacking. Individuals making requests in person will be informed of any deficiency in the specification of records at the time the request is made. Individuals making requests in writing will be notified of any such deficiency when their request is acknowledged.
An individual requesting access to records about himself may be accompanied by another individual of his own choosing. Both the individual requesting access and the individual accompanying him shall sign the required form indicating that the Nuclear Regulatory Commission is authorized to discuss the contents of the subject record in the presence of both individuals.
(a) Written requests by individuals to verify the existence of, obtain access to or correct or amend records about themselves maintained by NRC in a system of records subject to the provisions of the Privacy Act of 1974, shall be acknowledged in writing by the Freedom of Information Act and Privacy Act Officer within ten working days after date of actual receipt. The acknowledgement shall advise the requestor if any additional information is needed to process the request. Wherever practicable, the acknowledgement shall notify the individual whether his request to obtain access to the record or to correct or amend the record has been granted or denied.
(b) When an individual requests access to records or permission to correct or amend records in person, every effort will be made to make an immediate determination as to whether access or correction or amendment should be granted. If an immediate determination cannot be made, the request will be processed in the same manner as a written request. Records will be made available for immediate inspection whenever possible.
(a) When an individual requests information concerning the existence of, or access to, records about himself which have been compiled in reasonable anticipation of a civil action or proceeding in either a court or before an administrative tribunal, the NRC shall advise the individual only that no record available to him pursuant to the Privacy Act of 1974 has been identified.
(b)
(1) Information compiled for the purpose of identifying individual criminal offenders and alleged offenders and consisting only of identifying data and notations of arrests, the nature and disposition of criminal charges, sentencing, confinement, release and parole, and probation status;
(2) Information compiled for the purpose of a criminal investigation, including reports of informants and investigators, and associated with an identifiable individual; or
(3) Reports identifiable to an individual compiled at any stage of the process of enforcement of the criminal laws from arrest or indictment through release from supervision.
(c)
(1)
(ii) Information which no longer warrants classification under these criteria shall be declassified and made available to the individual. If the requested information has been classified by another agency, the responsible official of the NRC will request the classifying agency to review the information to ascertain if classification is still warranted. If the information continues to warrant classification, the individual shall be advised that the information sought is classified, that it has been reviewed and continues to warrant classification, and that it has been exempted from access pursuant to 5 U.S.C. 552a(k)(1).
(2)
(3)
(4)
(5)
(a)
(2)
(a)
(1) Notices granting access shall inform the individual when and where the requested record may be seen, how copies may be obtained, and of any fees or anticipated charges which may be incurred pursuant to § 9.85 of this subpart.
(2) Notices denying access must state the reasons for the denial, and advise the individual that the denial may be appealed to the Inspector General, for agency records located in the Office of Inspector General, or the Executive Director for Operations, for all other agency records, in accordance with the procedures set forth in this section.
(b)
(c)
(2) If the Inspector General, or the Executive Director for Operations or the EDO's designee, determines that access was properly denied because the information requested has been exempted from disclosure, the Inspector General, or the Executive Director for Operations or the EDO's designee shall undertake a review of the exemption to determine whether the information should continue to be exempt from disclosure. The Inspector General, or the Executive Director for Operations or the EDO's designee, shall notify the individual in writing of the final agency determination to grant or deny the request for access. Notices denying access must state the reasons therefor and must advise the individual of his/her right to judicial review pursuant to 5 U.S.C. 552a(g).
(a)
(i) Records shall contain only such information about an individual as is relevant and necessary to accomplish an NRC function required to be accomplished by statute or by executive order of the President;
(ii) Records used by NRC in making any determination about any individual shall be as accurate, relevant, current, and complete as is reasonably necessary to assure fairness to the individual in the determination;
(iii) No record shall describe how any individual has exercised rights guaranteed by the First Amendment unless such record is expressly authorized by statute or by the individual about whom the record is maintained, or is pertinent to and within the scope of an authorized law enforcement activity.
(2) For agency records located in the Office of Inspector General, if correction or amendment of a record is authorized, the Assistant Inspector General for Investigations shall correct or amend the record. For all other agency records, the Freedom of Information Act and Privacy Act Officer shall correct or amend the record. The Freedom of Information Act and Privacy Act Officer shall notify the requesting individual in writing that the correction or amendment has been made and provide the individual with a courtesy copy of the corrected record.
(3) If correction or amendment of a record is refused, the Freedom of Information Act and Privacy Act Officer shall notify the requesting individual in writing of the refusal and the reasons therefor, and shall advise the individual that the refusal may be appealed to the Inspector General or the Executive Director for Operations, as appropriate, in accordance with the procedures set forth in this section.
(b)
(c)
(2) For agency records located in the Office of the Inspector General, if the Inspector General makes a final determination that an amendment or correction of the record is warranted on the facts, the Inspector General or the IG's designee, shall correct or amend the record pursuant to the procedures in § 9.66(a)(2). For all other agency records, if the Executive Director for Operations, or the EDO's designee, makes a final determination that an amendment or correction of the record is warranted on the facts, the EDO or the EDO's designee, shall notify the Freedom of Information Act and Privacy Act Officer to correct or amend the record to the procedures in § 9.66(a)(2).
(3) If the Inspector General, or the Executive Director for Operations or the EDO's designee, makes a final determination that an amendment or correction of the record is not warranted on the facts, the individual shall be notified in writing of the refusal to authorize correction or amendment of the record in whole or in part, and of the reasons therefor, and the individual shall be advised of his/her right to provide a “Statement of Disagreement” for the record and of his/her right to judicial review pursuant to 5 U.S.C. 552a(g).
(a) Written “Statements of Disagreement” may be furnished by the individual within 30 working days of the date of receipt of the final adverse determination of the Inspector General or the Executive Director for Operations. “Statements of Disagreement” must be addressed, as appropriate, to the Inspector General or the Executive Director for Operations, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and should be clearly marked on the statement and on the envelope “Privacy Act Statement of Disagreement”.
(b) The Inspector General or the Executive Director for Operations, or their designees, as appropriate, are responsible for ensuring that: (1) The “Statement of Disagreement” is included in the system or systems of records in which the disputed item of information is maintained; and (2) the original record is marked to indicate the information disputed, the existence of a “Statement of Disagreement” and
The Inspector General, or the Executive Director for Operations or the EDO's designee, may if deemed appropriate, prepare a concise statement of the reasons why the requested amendments or corrections were not made. Any NRC “Statement of Explanation” must be included in the system of records in the same manner as the “Statement of Disagreement”. Courtesy copies of the NRC statement and of the notation of the dispute as marked on the original record must be furnished to the individual who requested correction or amendment of the record.
(a) When a record has been corrected upon request or when a “Statement of Disagreement” has been filed, the Freedom of Information Act and Privacy Act Officer shall, within 30 working days thereof, advise all prior recipients of the affected record whose identity can be determined pursuant to an accounting of disclosures required by the Privacy Act or any other accounting previously made, of the correction or of the filing of the “Statement of Disagreement”.
(b) Any disclosure of disputed information occurring after a “Statement of Disagreement” has been filed shall clearly identify the specific information disputed and be accompanied by a copy of the “Statement of Disagreement” and a copy of any NRC “Statement of Explanation”.
(a) NRC Commissioners and NRC personnel shall not disclose any record which is contained in a system of records maintained by NRC by any means of communication to any person, or to another Government agency, except pursuant to a written request by, or with the prior written consent of, the individual to whom the record pertains, unless disclosure of the record is:
(1) To NRC Commissioners and NRC personnel who have a need for the record in the performance of their duties;
(2) Required under 5 U.S.C. 552;
(3) For a routine use published in the
(4) To the Bureau of the Census for purposes of planning or carrying out a census or survey or related activity pursuant to the provisions of Title 13 of the United States Code;
(5) To a recipient who has provided the agency with advance adequate written assurance that the record will be used solely as a statistical research or reporting record and the record is transferred in a form that is not individually identifiable. The advance written statement of assurance shall (i) state the purpose for which the record is requested, and (ii) certify that the record will be used only for statistical purposes. Prior to release for statistical purposes in accordance with the provisions of this paragraph, the record shall be stripped of all personally identifying information and reviewed to ensure that the identity of any individual cannot reasonably be determined by combining two or more statistical records;
(6) To the National Archives and Records Administration as a record that has sufficient historical or other value to warrant its continued preservation by the United States Government, or to the Archivist of the United States or designee for evaluation to determine whether the record has such value;
(7) To another agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States for a civil or criminal law enforcement activity if the activity is authorized by law, and if the head of the agency or instrumentality has made a written request to the NRC specifying the particular portion of the
(8) To any person upon a showing of compelling circumstances affecting the health or safety of any individual;
(9) To either House of Congress or, to the extent of matter within its jurisdiction, to any committee or subcommittee thereof or to any joint committee of the Congress or to any subcommittee of such joint committee;
(10) To the Comptroller General, or any authorized representatives, in the course of the performance of the duties of the General Accounting Office;
(11) Pursuant to the order of a court of competent jurisdiction; or
(12) To a consumer reporting agency in accordance with 31 U.S.C. 3711(f).
(b) [Reserved]
When records concerning an individual are subpoenaed or otherwise disclosed pursuant to court order, the NRC officer or employee served with the subpoena shall be responsible for assuring that the individual is notified of the disclosure within five days after such subpoena or other order becomes a matter of public record. The notice shall be mailed to the last known address of the individual and shall contain the following information: (a) The date the subpoena is returnable; (b) the court in which it is returnable; (c) the name and number of the case or proceeding; and (d) the nature of the information sought.
When information concerning an individual has been disclosed to any person under compelling circumstances affecting health or safety, the NRC officer or employee who made or authorized the disclosure shall notify the individual at his last known address within five days of the disclosure. The notice shall contain the following information: (a) The nature of the information disclosed; (b) the person or agency to whom the information was disclosed; (c) the date of the disclosure; and (d) the compelling circumstances justifying the disclosure.
Fees shall not be charged for search for or review of records requested pursuant to this subpart or for making copies or extracts of records in order to make them available for review. Fees established pursuant to 31 U.S.C. 483c and 5 U.S.C. 552a(f)(5) shall be charged according to the schedule contained in § 9.35 of this part for actual copies of records requested by individuals, pursuant to the Privacy Act of 1974, unless the Freedom of Information Act and Privacy Act Officer waives the fee because of the inability of the individual to pay or because making the records available without cost, or at a reduction in cost, is otherwise in the public interest.
(a) An injunction or other court order may be obtained pursuant to 5 U.S.C. 552a(g) (1-3) to compel NRC to permit an individual to review, amend or copy a record pertaining to him, or to be accompanied by someone of his own choosing when he reviews his record. A court order may be obtained for the payment of a civil penalty imposed pursuant to 5 U.S.C. 552a(g)(4) if NRC intentionally or willfully fails to maintain a record accurately, or fails to comply with any provision of 5 U.S.C. 552a, or any provision of this subpart, if such failure results in an adverse determination or has an adverse effect on an individual. Court costs and attorney's fees may be awarded in civil actions.
(b) Any officer or employee of NRC who willfully maintains a system of
The following records contained in the designated NRC Systems of Records (NRC-5, NRC-9, NRC-11, NRC-18, NRC-22, NRC-23, NRC-28, NRC-29, NRC-31, NRC-33, NRC-35, NRC-37, and NRC-39) are exempt from 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), (H), and (I), and (f) in accordance with 5 U.S.C. 552a(k). In addition, the records contained in NRC-18 are exempt from the provisions of 5 U.S.C. 552a and the regulations in this part, under 5 U.S.C. 552a(j)(2), except subsections (b), (c) (1) and (2), (e)(4) (A) through (F), (e) (6), (7), (9), (10), and (11), and (i). Each of these systems of records is subject to the provisions of § 9.61:
(a) Contracts Records Files, NRC-5 (Exemptions (k)(1) and (k)(5));
(b) Equal Employment Opportunity Discrimination Complaint Files, NRC-9 (Exemption (k)(5));
(c) General Personnel Records (Official Personnel Folder and Related Records), NRC-11 (Exemptions (k)(5) and (k)(6));
(d) Office of the Inspector General (OIG) Investigative Records, NRC-18 (Exemptions (j)(2), (k)(1), (k)(2), (k)(5), and (k)(6));
(e) Personnel Performance Appraisals, NRC-22 (Exemptions (k)(1) and (k)(5));
(f) Office of Investigations Indices, Files, and Associated Records, NRC- 23 (Exemptions (k)(1), (k)(2), and (k)(6));
(g) Recruiting, Examining, and Placement Records, NRC-28 (Exemption (k)(5));
(h) Nuclear Documents System (NUDOCS), NRC-29 (Exemption (k)(1));
(i) Correspondence and Records, Office of the Secretary, NRC-31 (Exemption (k)(1));
(j) Special Inquiry File, NRC-33 (Exemptions (k)(1), (k)(2), and (k)(5));
(k) Drug Testing Program Records, NRC-35 (Exemption (k)(5));
(l) Information Security Files and Associated Records, NRC-37 (Exemptions (k)(1) and (k)(5)); and
(m) Personnel Security Files and Associated Records, NRC-39 (Exemptions (k)(1), (k)(2), and (k)(5)).
This subpart prescribes procedures pursuant to which NRC meetings shall be open to public observation pursuant to the provisions of 5 U.S.C. 552b. This subpart does not affect the procedures pursuant to which NRC records are made available to the public for inspection and copying which remain governed by subpart A, except that the exemptions set forth in § 9.104(a) shall govern in the case of any request made pursuant to § 9.23 to copy or inspect the transcripts, recordings, or minutes described in § 9.108. Access to records considered at NRC meetings shall continue to be governed by subpart A of this part.
As used in this subpart:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
Commissioners shall not jointly conduct or dispose of Commission business in Commission meetings other than in accordance with this subpart. Except as provided in § 9.104, every portion of every meeting of the Commission shall be open to public observation.
The Secretary shall ensure that all open Commission meetings are held in a location such that there is reasonable space and adequate visibility and acoustics, for public observation. No additional right to participate in Commission meetings is granted to any person by this subpart. An open meeting is not part of the formal or informal record of decision of the matters discussed therein except as otherwise required by law. Statements of views or expressions of opinion made by Commissioners or NRC employees at open meetings are not intended to represent final determinations or beliefs. Such statements may not be pleaded, cited, or relied upon before the Commission or in any proceeding under part 2 of these regulations (10 CFR part 2) except as the Commission may direct. Members of the public attending open Commission meetings may use small electronic sound recorders to record the meeting, but the use of other electronic recording equipment and cameras requires the advance written approval of the Secretary.
(a) Except where the Commission finds that the public interest requires otherwise, Commission meetings shall be closed, and the requirements of §§ 9.105 and 9.107 shall not apply to any information pertaining to such meeting otherwise required by this subpart to be disclosed to the public, where the Commission determines in accordance with the procedures of § 9.105 that opening such meetings or portions thereof or disclosing such information, is likely to:
(1) Disclose matters that are (i) specifically authorized under criteria established by an Executive order to be kept secret in the interests of national defense or foreign policy, and (ii) in fact properly classified pursuant to such Executive order;
(2) Relate solely to the internal personnel rules and practices of the Commission;
(3) Disclose matters specifically exempted from disclosure by statute (other than 5 U.S.C. 552) provided that such statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld;
(4) Disclose trade secrets and commercial or financial information obtained from a person and privileged or confidential, including such information as defined in § 2.790(d) of this title;
(5) Involve accusing any person of a crime, imposing a civil penalty on any person pursuant to 42 U.S.C. 2282 or 42 U.S.C. 5846, or any revocation of any license pursuant to 42 U.S.C. sec. 2236, or formally censuring any person;
(6) Disclose information of a personal nature where such disclosure would constitute a clearly unwarranted invasion of personal privacy;
(7) Disclose investigatory reports compiled for law enforcement purposes, including specifically enforcement of the Atomic Energy Act of l1954, as amended, 42 U.S.C. 2011
(8) [Reserved]
(9) Disclose information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed Commission action, except that this subparagraph shall not apply in any instance where the Commission has already disclosed to the public the content or nature of its proposed action, or where the Commission is required to make such disclosure on its own initative prior to taking final action on such proposal; or
(10) Specifically concern the Commission's issuance of a subpoena, or the Commission's participation in a civil action or proceeding or an action or proceeding before a state or federal administrative agency, an action in a foreign court or international tribunal, or an arbitration, or the initiation, conduct or disposition by the Commission of a particular case of formal agency adjudication pursuant to 5 U.S.C. 554 or otherwise involving a determination on the record after an opportunity for a hearing pursuant to part 2 or similar provisions.
(b) Examples of situations in which Commission action may be deemed to be significantly frustrated are: (1) If opening any Commission meeting or negotiations would be likely to disclose information provided or requests made to the Commission in confidence by persons outside the Commission and which would not have been provided or made otherwise; (2) if opening a meeting or disclosing any information would reveal legal or other policy advice, public knowledge of which could substantially affect the outcome or conduct of pending or reasonably anticipated litigation or negotiations; or (3) if opening any meeting or disclosing any information would reveal information requested by or testimony or proposals to be given to other agencies of government, including the Congress and the Executive Branch before the requesting agency would receive the information, testimony or proposals. The examples in the above sentence are for illustrative purposes only and are not intended to be exhaustive.
(a) Action under § 9.104 shall be taken only when a majority of the entire membership of the Commission votes to take such action. A separate vote of the Commissioners shall be taken with respect to each Commission meeting a portion or portions of which are proposed to be closed to the public pursuant to § 9.104, or which respect to any information which is proposed to be withheld under § 9.105(c). A single vote may be taken with respect to a series of meetings, a portion or portions of which are proposed to be closed to the public, or with respect to any information concerning such series of meetings, so long as each meeting in such series involves the same particular matters and is scheduled to be held no more than thirty days after the initial meeting in such series. The vote of each Commissioner participating in
(b) Within one day of any vote taken pursuant to paragraph (a) of this section, § 9.106(a), or § 9.108(c), the Secretary shall make publicly available at the NRC Web site,
(c) The notices and lists required by paragraph (b) of this section to be made public may be withheld from the public to the extent that the Commission determines that such information itself would be protected against disclosure by § 9.104(a). Any such determination shall be made independently of the Commission's determination pursuant to paragraph (a) of this section to close a meeting, but in accordance with the procedure of that subsection. Any such determination, including a written explanation for the action and the specific provision or provisions of § 9.104(a) relied upon, must be made publicly available to the extent permitted by the circumstances.
(a) Whenever any person whose interests may be directly affected by a portion of a meeting requests that the Commission close such portion to the public for any of the reasons referred to in paragraphs (a) (5), (6), or (7) of § 9.104, the Commission, upon request of any one Commissioner, shall vote by recorded vote whether to close such meeting.
(b) Any person may petition the Commission to reconsider its action under § 9.105(a) or paragraph (a) of this section by filing a petition for reconsideration with the Commission within seven days after the date of such action and before the meeting in question is held.
(c) A petition for reconsideration filed pursuant to paragraph (b) of this section shall state specifically the grounds on which the Commission action is claimed to be erroneous, and shall set forth, if appropriate, the public interest in the closing or opening of the meeting. The filing of such a petition shall not act to stay the effectiveness of the Commission action or to postpone or delay the meeting in question unless the Commission orders otherwise.
(a) In the case of each meeting, the Secretary shall make public announcement, at least one week before the meeting, of the time, place, and subject matter of the meeting, whether it is to be open or closed to the public, and the name and phone number of the official designated by the Commission to respond to requests for information about the meeting. Such announcement shall be made unless a majority of the members of the Commission determines by a recorded vote that Commission business requires that such meeting be called at an earlier date, in which case the Secretary shall make public announcement of the time, place and subject matter of such meeting, and whether open or closed to the public, at the earliest practical time.
(b) The time or place of a meeting may be changed following the public announcement required by paragraph (a) of this section only if the Secretary publicly announces such changes at the earliest practicable time. The subject matter of as meeting, or the determination of the Commission to open or close a meeting, or portion of a meeting, to the public, may be changed following the public announcement required by this subsection only if: (1) A majority of the entire membership of the Commission determines by a recorded vote that Commission business so requires and that no earlier announcement of the change was possible, and (2) the Secretary publicly announces such change and the vote of each member upon such change at the earliest practicable time.
(c) Immediately following each public announcement required by this section, notice of the time, place, and subject matter of a meeting, whether the meeting is open or closed, any change in one of the preceding, and the name and phone number of the official designated by the Commission to respond to requests for information about the meeting, shall also be submitted for publication in the
(d) The public announcement required by paragraph (a) of this section shall consist of the Secretary:
(1) Publicly posting a copy of the document at the NRC Web site, http://www.nrc.gov and, to the extent appropriate under the circumstances;
(2) Mailing a copy to all persons whose names are on a mailing list maintained for this purpose;
(3) Submitting a copy for possible publication to at least two newspapers of general circulation in the Washington, DC metropolitan area;
(4) Any other means which the Secretary believes will serve to further inform any persons who might be interested.
(e) Action under the second sentence of paragraph (a) or (b) of this section shall be taken only when the Commission finds that the public interest in prompt Commission action or the need to protect the common defense or security or to protect the public health or safety overrides the public interest in having full prior notice of Commission meetings.
(a) For every meeting closed pursuant to paragraphs (a) (1) through (10) of § 9.104 and for every determination pursuant to § 9.105(c), the General Counsel shall publicly certify at the time of the public announcement of the meeting, or if there is no public announcement at the earliest practical time, that, in his or her opinion, the meeting may be closed to the public and shall state each relevant exemptive provision unless the Commission votes pursuant to § 9.105(c) that such certification is protected against disclosure by § 9.104(a). A copy of such certification, together with a statement from the presiding officer of the meeting setting forth the time and place of the meeting, and the persons present, shall be retained by the Commission. The Commission shall maintain a complete transcript or electronic recording adequate to record fully the proceedings of each meeting, or portion of a meeting closed to the public, except that in the case of a meeting, or portion of a meeting, closed to the public pursuant to paragraph (c)(10) of § 9.104, the Commission shall maintain such a transcript, or recording or a set of minutes. Such minutes shall fully and clearly describe all matters discussed and shall provide a full and accurate summary of any actions taken, and the reasons therefor, including a description of each of the views expressed on any item and the record of any rollcall vote (reflecting the vote of each Commissioner on the question). All documents considered in connection with any action shall be identified in such minutes.
(b) The Commission shall make promptly available to the public at the NRC Web site,
(c) In the case of any meeting closed pursuant to § 9.104, the Secretary of the Commission, upon the advice of the General Counsel and after consultation with the Commission, shall determine which, if any, portions of the electronic recording, transcript or minutes and which, if any, items of information withheld pursuant to § 9.105(c) contain information which should be withheld pursuant to § 9.104, in the event that a request for the recording, transcript, or minutes is received within the period during which the recording, transcript, or minutes must be retained, under paragraph (b) of this section.
(d) If at some later time the Commission determines that there is no further justification for withholding any transcript, recording or other item of information from the public which has previously been withheld, then such information shall be made available.
The Secretary shall annually report to the Congress regarding the Commission's compliance with the Government in the Sunshine Act, including a tabulation of the total number of open meetings, the total number of closed meetings, the reasons for closing such meetings and a description of any litigation brought against the Commission pursuant to the Government in the Sunshine Act, including any cost assessed against the Commission in such litigation (whether or not paid by the Commission).
(a) This subpart sets forth the procedures to be followed when a subpoena, order, or other demand (hereinafter referred to as a “demand”) for the production of NRC records or disclosure of NRC information, including testimony regarding such records, is issued by a court or other judicial or quasi-judicial authority in a proceeding, excluding Federal grand jury proceedings, to which the NRC is not a party. Information and documents subject to this subpart include:
(1) Any material contained in the files of the NRC;
(2) Any information relating to material contained in the files of the NRC.
(b) For purposes of this subpart, the term “employee of the NRC” includes all NRC personnel as that term is defined in § 9.3 of this part, including NRC contractors.
(c) This subpart is intended to provide instructions regarding the internal operations of the NRC and is not intended, and does not, and may not, be relied upon to create any right or benefit, substantive or procedural, enforceable at law by a party against the NRC.
No employee of the NRC shall, in response to a demand of a court or other judicial or quasi-judicial authority, produce any material contained in the files of the NRC or disclose, through testimony or other means, any information relating to material contained in the files of the NRC, or disclose any information or produce any material acquired as part of the performance of that employee's official duties or official status without prior approval of the appropriate NRC official. When the demand is for material contained in the files of the Office of the Inspector General or for information acquired by an employee of that Office, the Inspector General is the appropriate NRC official. In all other cases, the General Counsel is the appropriate NRC official.
(a) Prior to or simultaneous with a demand upon an employee of the NRC for the production of material or the disclosure of information described in
(b)(1) If oral testimony is sought by the demand, a summary of the testimony desired must be furnished to the General Counsel by a detailed affidavit or, if that is not feasible, a detailed statement by the party seeking the testimony or the party's attorney. This requirement may be waived by the General Counsel in appropriate circumstances.
(2) The General Counsel may request a plan from the party seeking discovery of all demands then reasonably foreseeable, including but not limited to, names of all NRC personnel from whom discovery is or will be sought, areas of inquiry, length of time away from duty involved, and identification of documents to be used in each deposition, where appropriate.
(c) The Inspector General or the General Counsel will notify the employee and such other persons, as circumstances may warrant, of the decision on the matter.
If a response to the demand is required before the instructions from the Inspector General or the General Counsel are received, a U.S. attorney or NRC attorney designated for the purpose shall appear with the employee of the NRC upon whom the demand has been made, and shall furnish the court or other authority with a copy of the regulations contained in this subpart and inform the court or other authority that the demand has been, or is being, as the case may be, referred for the prompt consideration of the appropriate NRC official and shall respectfully request the court or authority to stay the demand pending receipt of the requested instructions. In the event that an immediate demand for production or disclosure is made in circumstances which would preclude the proper designation or appearance of a U.S. or NRC attorney on the employee's behalf, the employee shall respectfully request the demanding authority for sufficient time to obtain advice of counsel.
If the court or other judicial or quasi-judicial authority declines to stay the effect of the demand in response to a request made in accordance with § 9.203 pending receipt of instructions, or if the court or other authority rules that the demand must be complied with irrespective of instructions not to produce the material or disclose the information sought, the employee upon whom the demand has been made shall respectfully decline to comply with the demand, citing these regulations and
Secs. 145, 161, 68 Stat. 942, 948, as amended (42 U.S.C. 2165, 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); E.O. 10450, 3 CFR parts 1949—1953 COMP., p. 936, as amended; E.O. 10865, 3 CFR 1959-1963 COMP., p. 398, as amended; 3 CFR Table 4.; E.O. 12968, 3 CFR 1995 COMP., p.396.
(a) This part establishes the criteria, procedures, and methods for resolving questions concerning:
(1) The eligibility of individuals who are employed by or applicants for employment with NRC contractors, agents, and licensees of the NRC, individuals who are NRC employees or applicants for NRC employment, and other persons designated by the Deputy Executive Director for Management Services of the NRC, for access to Restricted Data pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, or for access to national security information; and
(2) The eligibility of NRC employees, or the eligibility of applicants for employment with the NRC, for employment clearance.
(b) This part is published to implement the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, Executive Order 10865, 25 FR 1583 (February 24, 1960) Executive Order 10450, 18 FR 2489 (April 27, 1954), and Executive Order 12968, 60 FR 40245 (August 2, 1995).
The criteria and procedures in this part shall be used in determining eligibility for NRC access authorization and/or employment clearance involving:
(a) Employees (including consultants) of contractors and agents of the Nuclear Regulatory Commission and applicants for employment;
(b) Licensees of the NRC and their employees (including consultants) and applicants for employment;
(c) NRC employees (including consultants) and applicants for employment; and
(d) Any other person designated by the Deputy Executive Director for Management Services of the Nuclear Regulatory Commission.
It is the policy of the Nuclear Regulatory Commission to carry out its responsibility for the security of the nuclear energy program in a manner consistent with traditional American concepts of justice. To this end, the Commission has established criteria for determining eligibility for access authorization and/or employment clearance
(a) The decision as to access authorization and/or employment clearance is a comprehensive, common-sense judgment, made after consideration of all the information, favorable or unfavorable, relevant to whether the granting of access authorization and/or employment clearance would not endanger the common defense and security and would be clearly consistent with the national interest.
(b) The criteria in § 10.11 set forth a number of the types of derogatory information used to assist in making determinations of eligibility for access authorization and/or employment clearance. These criteria are not exhaustive but contain the principal types of derogatory information which create a question as to the individual's eligibility for access authorization and/or employment clearance. While there must necessarily be adherence to such criteria, the NRC is not limited to them, nor precluded from exercising its judgment that information or facts in
(c) When the reports of investigation of an individual contain information reasonably tending to establish the truth of one or more of the items in the criteria, such information shall be regarded as derogatory and shall create a question as to the individual's eligibility for access authorization and/or employment clearance. A question concerning the eligibility of an individual for access authorization and/or employment clearance shall be resolved in accordance with the procedures set forth in § 10.20
(d) In resolving a question concerning the eligibility or continued eligibility of an individual for access authorization and/or employment clearance, the following principles shall be applied by the Director, Division of Facilities and Security, Hearing Examiners, and the NRC Personnel Security Review Panel:
(1) Information reasonably tending to establish the truth of one or more of the items in the criteria shall be the basis for recommending denial or revocation of access authorization and/or employment clearance unless evidence to support faith in the individual's reliability and trust-worthiness is affirmatively shown.
(2) When deemed material to the deliberations, the extent of the activity, conduct, or condition, the period in which they occurred or existed, the length of time which has since elapsed, and the attitude and convictions of the individual shall be considered in determining whether the recommendation will be adverse or favorable.
(a) The criteria for determining eligibility for access authorization and/or employment clearance shall relate, but not be limited, to the following where an individual:
(1) Committed, attempted to commit, aided, or abetted another who committed or attempted to commit any act of sabotage, espionage, treason, sedition, or terrorism.
(2) Publicly or privately advocated actions that may be inimical to the interest of the United States, or publicly or privately advocated the use of force or violence to overthrow the Government of the United States or the alteration of the form of government of the United States by unconstitutional means.
(3) Knowingly established or continued a sympathetic association with a saboteur, spy, traitor, seditionist, anarchist, terrorist, or revolutionist, or with an espionage agent or other secret agent or representative of a foreign nation whose interests may be inimical to the interests of the United States, or with any person who advocates the use of force or violence to overthrow the Government of the United States or the alteration of the form of government of the United States by unconstitutional means.
(4) Joined or engaged in any activity knowingly in sympathy with or in support of any foreign or domestic organization, association, movement, group, or combination of persons which unlawfully advocates or practices the commission of acts of force or violence to prevent others from exercising their rights under the Constitution or laws of the United States or any State or any subdivisions thereof by unlawful means, or which advocate the use of force and violence to overthrow the Government of the United States or the alteration of the form of government of the United States by unconstitutional means. (Ordinarily, criteria (3) and (4) will not include chance or casual meetings or contacts limited to normal business or official relations.)
(5) Deliberately misrepresented, falsified or omitted relevant and material facts from or in a personnel security questionnaire, a personal qualifications statement, a personnel security interview, or any other information submitted pursuant this part.
(6) Willfully violated or disregarded security regulations or was grossly negligent with respect thereto to a degree which could endanger the common defense and security; or by intention or gross carelessness disclosed Restricted Data or national security information
(7) Has any illness or mental condition which in the opinion of competent medical authority may cause significant defect in the judgment or reliability of the individual.
(8) Has been convicted of crimes indicating habitual criminal tendencies.
(9) Has been convicted of a crime, or has a background, where the facts, circumstances, or conduct are of a nature indicating poor judgment, unreliabilty, or untrustworthiness.
(10) Is a user of alcohol habitually and to excess, or has been such without adequate evidence of rehabilitation.
(11) Has been, or is, a user of a drug or other substance listed in the schedules of Controlled Substances established pursuant to the Controlled Substances Act of 1970 (such as amphetamines, barbiturates, narcotics, etc.), except as prescribed or administered by a physician licensed to dispense drugs in the practice of medicine, without adequate evidence of rehabilitation.
(12) Refused, without satisfactory explanation, to answer questions before a congressional committee, Federal or state court, or Federal administrative body including the NRC regarding charges relevant to the individual's eligibility for access authorization and/or employment clearance.
(13) Engaged in any other conduct or is subject to any other circumstances which tend to show that the individual is not reliable or trustworthy, or which furnishes reason to believe that the individual may be subject to coercion, influence, or pressures which may cause the individual to act contrary to the national interest.
(a) The Director, Division of Facilities and Security, Office of Administration, may authorize the granting of access authorization and/or employment clearance on the basis of the information in the possession of the NRC or may authorize an interview with the individual, if the individual consents to be interviewed, or other investigation as the Director deems appropriate. On the basis of this interview and/or an investigation, the Director may authorize the granting of access authorization and/or employment clearance.
(b) The individual may elect on constitutional or other grounds not to participate in an interview or other investigation; however, such refusal or failure to furnish or authorize the furnishing of relevant and material information is deemed to be derogatory information pursuant to § 10.11(a) (5) and (12).
(c) If the Director, Division of Facilities and Security, cannot make a favorable finding regarding the eligibility of an individual for access authorization and/or employment clearance, the question of the individual's eligibility must be resolved in accordance with the procedures set forth in § 10.20
These procedures establish methods for the conduct of hearings and administrative review of questions concerning an individual's eligibility for an access authorization and/or an employment clearance pursuant to the Atomic Energy Act of 1954, as amended, and Executive Orders 10450, 10865, and 12968 when a resolution favorable to the individual cannot be made on the basis of the interview or other investigation.
In those cases where information is received which raises a question concerning the continued eligibility of an individual for an access authorization and/or an employment clearance, the Director, Division of Facilities and Security, through the Director, Office of Administration, shall forward to the Deputy Executive Director for Management Services or other Deputy Executive Director, his or her recommendation as to whether the individual's access authorization and/or employment clearance should be suspended pending the final determination resulting from
A notification letter, prepared by the Division of Facilities and Security, approved by the Office of the General Counsel, and signed by the Director, Office of Administration, must be presented to each individual whose eligibility for an access authorization and/or an employment clearance is in question. Where practicable, the letter will be presented to the individual in person. The letter will be accompanied by a copy of this part and must state:
(a) That reliable information in the possession of the NRC has created a substantial doubt concerning the individual's eligibility for an access authorization and/or an employment clearance;
(b) The information that creates a substantial doubt regarding the individual's eligibility for an access authorization and/or an employment clearance, that must be as comprehensive and detailed as the national security interests and other applicable law permit;
(c) That the individual has the right to be represented by counsel or other representative at their own expense;
(d) That the individual may request within 20 days of the date of the notification letter, any documents, records and reports which form the basis for the question of their eligibility for an access authorization and/or an employment clearance. The individual will be provided within 30 days all such documents, records and reports to the extent they are unclassified and do not reveal a confidential source. The individual may also request the entire investigative file, which will be promptly provided, as permitted by the national security interests and other applicable law;
(e) That unless the individual files with the Director, Office of Administration, a written request for a hearing within 20 days of the individual's receipt of the notification letter or 20 days after receipt of the information provided in response to a request made under paragraph (d) of this section, whichever is later, the Director, Division of Facilities and Security, through the Director, Office of Administration, will submit a recommendation as to the final action to the Deputy Executive Director for Management Services on the basis of the information in the possession of the NRC;
(f) That if the individual files a written request for a hearing with the Director, Office of Administration, the individual shall file with that request a written answer under oath or affirmation that admits or denies specifically each allegation and each supporting fact contained in the notification letter. A general denial is not sufficient to controvert a specific allegation. If the individual is without knowledge, he or she shall so state and that statement will operate as a denial. The answer must also state any additional facts and information that the individual desires to have considered in explanation or mitigation of allegations in the notification letter. Failure to specifically deny or explain or deny knowledge of any allegation or supporting fact will be deemed an admission that the allegation or fact is true.
(g) That if the individual does not want to exercise his or her right to a hearing, but does want to submit an answer to the allegations in the notification letter, the individual may do so by filing with the Director, Office of Administration, within 20 days of receipt of the notification letter or 20 days after receipt of the information provided in response to a request made under paragraph (d) of this section, whichever is later, a written answer in accordance with the requirements of paragraph (f) of this section;
(h) That the procedures in § 10.24
(a) In the event the individual fails to file a timely written request for a hearing pursuant to § 10.22, a recommendation as to the final action to be taken will be made by the Director, Division of Facilities and Security, through the Director, Office of Administration, to the Deputy Executive Director for Management Services on the basis of the information in the possession of the NRC, including any answer filed by the individual.
(b) The Director, Office of Administration, may for good cause shown, at the request of the individual, extend the time for filing a written request for a hearing or for filing a written answer to the matters contained in the notification letter.
(a) Upon receipt of a timely filed request for a hearing and answer complying with the requirements set forth in § 10.22, the Director, Office of Administration, shall forthwith appoint a Hearing Examiner, and the General Counsel shall forthwith assign an NRC attorney to act as Hearing Counsel. The Director, Office of Administration, shall promptly notify the individual of the identity of the Hearing Examiner and proposed hearing date, which shall be selected with due regard for the convenience of the parties and their representatives.
(b) Within 72 hours of being notified of the identity of the Hearing Examiner, the individual may request that the Hearing Examiner be disqualified for cause by filing with the Director, Office of Administration, a written statement of the individual's reasons for seeking disqualification. The time for filing the request may be extended by the Director, Office of Administration, for good cause shown. If the Director, Office of Administration, grants the request the procedures of paragraph (a) of this section and this paragraph shall be followed just as though there had been no prior appointment.
(c) The individual shall have the right to appear at the hearing before the Hearing Examiner, to be represented by counsel or other representative, to introduce documentary or other evidence, and to call, examine, and cross-examine witnesses, subject to the provisions and limitations set forth in this part.
(a) Hearing Counsel assigned pursuant to § 10.24 will, before the scheduling of the hearing, review the information in the case and will request the presence of witnesses and the production of documents and other physical evidence relied upon by the Director, Division of Facilities and Security, in making a finding that a question exists regarding the eligibility of the individual for an NRC access authorization and/or an employment clearance in accordance with the provisions of this part. When the presence of a witness and the production of documents and other physical evidence is deemed by the Hearing Counsel to be necessary or desirable for a determination of the issues, the Director, Division of Facilities and Security, will make arrangements for the production of evidence and for witnesses to appear at the hearing by subpoena or otherwise.
(b) Hearing Counsel is authorized to consult directly with individual's counsel or representative or the individual, if the individual is not so represented, for purposes of reaching mutual agreement upon arrangements for expeditious hearing of the case. Such arrangements may include clarification of issues and stipulations with respect to testimony and contents of documents and other physical evidence. Such stipulations when entered into shall be binding upon the individual and the NRC for the purposes of this part. Prior to any consultation with the individual, the Hearing Counsel shall advise the individual of his or her rights under this part, of his or her
(c) The individual is responsible for producing witnesses in his or her own behalf and/or presenting other evidence before the Hearing Examiner to support the individual's answer and defense to the allegations contained in the notification letter. When requested by the individual, however, the Hearing Counsel may assist the individual to the extent practicable and necessary. The Hearing Counsel may at his or her discretion request the Director, Division of Facilities and Security, to arrange for the issuance of subpoenas for witnesses to attend the hearing in the individual's behalf, or for the production of specific documents or other physical evidence, provided a showing of the necessity for assistance has been made.
The appointment of a Hearing Examiner, pursuant to § 10.24 of this part, shall be from a list of qualified attorneys possessing the highest degree of integrity, ability, and good judgment. To qualify, an attorney shall have an NRC “Q” access authorization and may be an employee of the NRC, its contractors, agents or licensees. However, no employee or consultant of the NRC shall serve as Hearing Examiner hearing the case of an employee (including a consultant) or applicant for employment with the NRC; nor shall any employee or consultant of an NRC contractor, agent or licensee serve as Hearing Examiner hearing the case of an employee (including a consultant) or an applicant for employment of that contractor, agent, or licensee. No Hearing Examiner shall be selected who has knowledge of the case or of any information relevant to the disposition of it, or who for any reason would be unable to issue a fair and unbiased recommendation.
(a) After the appointment of the Hearing Examiner, he or she shall be furnished the record in the case, which shall consist of the letter of notification, the request for hearing and its supporting answer, and the notice of hearing, if it has been issued, and any stipulations agreed to by the individual and the Hearing Counsel.
(b) The Hearing Examiner may on his or her own motion, or on that of either party, convene a prehearing conference with the Hearing Counsel and the individual and his or her counsel or representative, if any, for the purpose of clarifying the issues, identifying witnesses who may be called, identifying documents and other physical evidence that may be offered into evidence, and entering into stipulations of fact.
(c) The parties will be notified by the Hearing Examiner at least ten days in advance of the hearing of the time and place of the hearing. For good cause shown, the Hearing Examiner may order postponements or continuances from time to time. If, after due notice, the individual fails to appear at the hearing, or appears but is not prepared to proceed, the Hearing Examiner shall, unless good cause is shown, return the case to the Director, Division of Facilities and Security, who shall make a recommendation on final action to be taken, through the Director, Office of Administration, to the Deputy Executive Director for Management Services on the basis of the information in the possession of the NRC.
(a) The Hearing Examiner shall conduct the hearing in an orderly, impartial and decorous manner. Technical rules of evidence may be relaxed so that a full evidentiary record may be made based on all material and relevant facts. Hearsay evidence may for good cause shown be received at the discretion of the Hearing Examiner and accorded such weight as the circumstances warrant.
(b) The proceedings shall be open only to duly authorized representatives
(c) Witnesses, including the individual, shall be examined under oath or affirmation by the party who called them and may be cross-examined by the other. The Hearing Examiner shall rule on all evidentiary matters, may further examine any witness, and may call for additional witnesses or the production of documentary or other physical evidence if, in the exercise of his or her discretion, such additional evidence is deemed necessary to the resolution of an issue.
(d) If it appears during the hearing that Restricted Data or national security information may be disclosed, the Hearing Examiner shall assure that disclosure is made only to persons authorized to receive it.
(e) The Hearing Examiner may, at any time during the hearing, permit the Hearing Counsel to amend the notification letter to add or modify allegations to be considered. In the event of such an amendment to the notification letter, the individual shall be given an opportunity to answer the amended allegations. If the changes are of such a substantial nature that the individual cannot answer the amended allegations without additional time, the Hearing Examiner shall grant such additional time as he or she deems necessary.
(f) The Hearing Examiner may receive and consider evidence in the form of depositions or responses to interrogatories upon a showing that the witness is not available for good reason such as death, serious illness or similar cause, or in the form of depositions, interrogatories, affidavits or statements with agreement of the parties. The Hearing Examiner may take official notice at any stage of the proceeding, where appropriate, of any fact not subject to reasonable dispute in that it is either (1) generally known within the United States or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned. A party is entitled upon timely request to an opportunity to be heard as to the propriety of taking such official notice. In the absence of prior notification the request may be made after notice is taken.
(g) Hearing Counsel shall examine and cross-examine witnesses and otherwise assist the Hearing Examiner in such a manner as to bring out a full and true disclosure of all facts, both favorable and unfavorable, having a bearing on the issues before the Hearing Examiner. In performing these duties, the Hearing Counsel shall avoid the attitude of a prosecutor and shall always bear in mind that the proceeding is an administrative hearing and not a trial.
(h) Hearing Counsel shall not participate in the deliberations of the Hearing Examiner, and shall express no opinion to the Hearing Examiner concerning the merits of the case. Hearing Counsel shall also, during the course of the hearing, advise the individual of his or her rights under these procedures when the individual is not represented by counsel or other representative.
(i) The individual shall be afforded an opportunity to cross-examine persons who have made oral or written statements adverse to the individual relating to a controverted issue except that any such statement may be received and considered by the Hearing Examiner without affording such opportunity in either of the following circumstances:
(1) The head of the department or agency supplying the statement certifies that the person who furnished the information is a confidential informant who has been engaged in obtaining intelligence information for the Government and that disclosure of the informant's identity would substantially harm the national interest or would endanger the well-being of the informant.
(2) The Commission has determined, after considering the information furnished by the investigative agency concerning the reliability of the person who furnished the information and the accuracy of the statement concerned, that the statement appears to be reliable and material, and that failure of the Hearing Examiner to receive and
(j)(1) Whenever the procedure under paragraph (i)(1) of this section is used, the individual shall be given a summary of the information which shall be as comprehensive and detailed as the national security permits.
(2) Whenever the procedure under paragraph (i)(2) is used, the individual shall be provided the identity of the person and the information to be considered.
(3) In both paragraph (i) (1) and (2) procedures, appropriate consideration shall be accorded to the fact that the individual did not have an opportunity to cross-examine such informant or person.
(k) Records provided by investigative agencies that were compiled as a regular or routine procedure by the business or agency from which obtained, or other physical evidence other than investigative reports, may be received and considered subject to rebuttal without authenticating witnesses, provided that the investigative agency furnished such information to the NRC pursuant to its responsibilities in connection with assisting the NRC in determining the individual's eligibility for access authorization and/or employment clearance.
(l) Records compiled in the regular course of business, or other physical evidence other than investigative reports, relating to a controverted issue which, because they are classified, may not be inspected by the individual, may be received and considered provided that:
(1) The Commission has made a determination that such records or other physical evidence appears to be material;
(2) The Commission has made a determination that failure to receive and consider such records or other physical evidence would, in view of the fact that access authorization and/or employment clearance is being sought, be substantially harmful to the national security; and
(3) To the extent that national security permits, a summary or description of such records or other physical evidence is made available to the individual. In every such case, information as to the authenticity and accuracy of such physical evidence furnished by the investigative agency shall be considered.
(m) If the Hearing Examiner determines that additional investigation of any material information is required, he or she shall request in writing that the Director, Office of Administration, arrange for the investigation and shall specify those issues upon which more evidence is requested and identify, where possible, any persons or sources that might provide the evidence sought.
(n) A written transcript of the entire proceeding must be made by a person possessing appropriate NRC access authorization and/or employment clearance and, except for portions containing Restricted Data or National Security Information, or other lawfully withholdable information, a copy of the transcript will be furnished the individual without cost. The transcript or recording will be made part of the applicant's or employee's personnel security file.
(a) The Hearing Examiner's findings and recommendation shall be based upon the entire record consisting of the transcript of the hearing, the documentary and other evidence adduced therein, and the letter of notification and answer. The Hearing Examiner shall also consider the circumstances of the receipt of evidence pursuant to § 10.28, the individual's record of past employment, and the nature and sensitivity of the job the individual is or may be expected to perform.
(b) The Hearing Examiner shall make specific findings on each allegation in the notification letter including the reasons for his or her findings, and shall make a recommendation as to the
(c) The Hearing Examiner's recommendation shall be predicated upon his or her findings. If, after considering all the factors in light of the criteria in this part, the Hearing Examiner is of the opinion that granting or continuing access authorization and/or employment clearance to the individual will not endanger the common defense and security and will be clearly consistent with the national interest, a favorable recommendation shall be made; otherwise, an adverse recommendation shall be made.
(d) The Hearing Examiner shall submit his or her findings and recommendation in a signed report together with the record of the case to the Director, Office Administration, with the least practical delay.
(e) The Hearing Examiner shall not consider the possible impact of the loss of the individual's services upon the NRC program.
After the close of the hearing, in the event the individual discovers new evidence not previously available or known to him or her, the individual may petition the Hearing Examiner if the Hearing Examiner's recommendation has not yet been issued, or thereafter, the Director, Office of Administration, to reopen the record to receive that evidence. If the Hearing Examiner or the Director, respectively, deem it material and appropriate, the record may be reopened to accept the evidence either by stipulation, with the agreement of the Hearing Counsel, or in a reconvened hearing.
(a) Upon receipt of the findings and recommendation from the Hearing Examiner, and the record, the Director, Office of Administration, shall forthwith transmit it to the Deputy Executive Director for Management Services who has the discretion to return the record to the Director, Office of Administration, for further proceedings by the Hearing Examiner with respect to specific matters designated by the Deputy Executive Director for Management Services.
(b)(1) In the event of a recommendation by the Hearing Examiner that an individual's access authorization and/or employment clearance be denied or revoked, the Deputy Executive Director for Management Services shall immediately notify the individual in writing of the Hearing Examiner's findings with respect to each allegation contained in the notification letter, and that the individual has a right to request a review of his or her case by the NRC Personnel Security Review Panel and of the right to submit a brief in support of his or her contentions. The request for a review must be submitted to the Deputy Executive Director for Management Services within five days after the receipt of the notice. The brief will be forwarded to the Deputy Executive Director for Management Services, for transmission to the NRC Personnel Security Review Panel not later than 10 days after receipt of the notice.
(2) In the event the individual fails to request a review by the NRC Personnel Security Review Panel of an adverse recommendation within the prescribed time, the Deputy Executive Director for Management Services may at his or her discretion request a review of the record of the case by the NRC Personnel Security Review Panel. The request will set forth those matters at issue in the hearing on which the Deputy Executive Director for Management Services desires a review by the NRC Personnel Security Review Panel.
(c) Where the Hearing Examiner has made a recommendation favorable to the individual, the Deputy Executive Director for Management Services may at his or her discretion request a review of the record of the case by the NRC Personnel Security Review Panel. If this request is made, the Deputy Executive Director for Management Services shall immediately cause the individual to be notified of that fact and of those matters at issue in the hearing
(d) In the event of a request for a review pursuant to paragraphs (b) and (c) of this section, the Hearing Counsel may file a brief within 10 days of being notified by the Deputy Executive Director for Management Services that a review has been requested. The brief will be forwarded to the Deputy Executive Director for Management Services for transmission to the NRC Personnel Security Review Panel.
(e) The Hearing Counsel may also request a review of the case by the NRC Personnel Security Review Panel. The request for review, which will set forth those matters at issue in the hearing on which the Hearing Counsel desires a review, will be submitted to the Deputy Director Executive for Management Services within five days after receipt of the Hearing Examiner's findings and recommendation. Within 10 days of the request for review, the Hearing Counsel may file a brief which will be forwarded to the Deputy Executive Director for Management Services for transmission to the NRC Personnel Security Review Panel. A copy of the request for review, and a copy of any brief filed, will be immediately sent to the individual. If the Hearing Counsel's request is for a review of a recommendation favorable to the individual, the individual may, within 10 days of receipt of a copy of the request for review, submit a brief concerning those matters at issue for consideration of the NRC Personnel Security Review Panel. The brief will be forwarded to the Deputy Executive Director for Management Services for transmission to the NRC Personnel Security Review Panel and Hearing Counsel. A copy of the brief will be made a part of the applicant's personnel security file.
(f) The time limits imposed by this section for requesting reviews and the filing of briefs may be extended by the Deputy Executive Director for Management Services for good cause shown.
(g) In the event a request is made for a review of the record by the NRC Personnel Security Review Panel, the Deputy Executive Director for Management Services shall send the record, with all findings and recommendations and any briefs filed by the individual and the Hearing Counsel, to the NRC Personnel Security Review Panel. If neither the individual, the Deputy Executive Director for Management Services, nor the Hearing Counsel requests a review, the final determination will be made by the Deputy Executive Director for Management Services on the basis of the record with all findings and recommendations.
(a) The Deputy Executive Director for Management Services shall designate an NRC Personnel Security Review Panel to conduct a review of the record of the case. The NRC Personnel Security Review Panel shall be comprised of three members, two of whom shall be selected from outside the security field. To qualify as an NRC Personnel Security Review Panel member, the person designated shall have an NRC “Q” access authorization and may be an employee of the NRC, its contractors, agents, or licensees. However, no employee or consultant of the NRC shall serve as an NRC Personnel Security Review Panel member reviewing the case of an employee (including a consultant) or applicant for employment with the NRC; nor shall any employee or consultant of an NRC contractor, agent or licensee serve as an NRC Personnel Security Review Panel member reviewing the case of an employee (including a consultant) or an applicant for employment of that contractor, agent, or licensee. No NRC Personnel Security Review Panel member shall be selected who has knowledge of the case or of any information relevant to the disposition of it, or who
(b) The NRC Personnel Security Review Panel shall consider the matter under review based upon the record supplemented by any brief submitted by the individual or the Hearing Counsel. The NRC Personnel Security Review Panel may request additional briefs as the Panel deems appropriate. When the NRC Personnel Security Review Panel determines that additional evidence or further proceedings are necessary, the record may be returned to the Deputy Executive Director for Management Services with a recommendation that the case be returned to the Director, Office of Administration, for appropriate action, which may include returning the case to the Hearing Examiner and reconvening the hearing to obtain additional testimony. When additional testimony is taken by the Hearing Examiner, a written transcript of the testimony will be made a part of the record and will be taken by a person possessing an appropriate NRC access authorization and/or employment clearance and, except for portions containing Restricted Data or National Security Information, or other lawfully withholdable information, a copy of the transcript will be furnished the individual without cost.
(c) In conducting the review, the NRC Personnel Security Review Panel shall make its findings and recommendations as to the eligibility or continued eligibility of an individual for an access authorization and/or an employment clearance on the record supplemented by additional testimony or briefs, as has been previously determined by the NRC Personnel Security Review Panel as appropriate.
(d) The NRC Personnel Security Review Panel shall not consider the possible impact of the loss of the individual's services upon the NRC program.
(e) If, after considering all the factors in light of the criteria set forth in this part, the NRC Personnel Security Review Panel is of the opinion that granting or continuing an access authorization and/or an employment clearance to the individual will not endanger the common defense and security and will be clearly consistent with the national interest, the NRC Personnel Security Review Panel shall make a favorable recommendation; otherwise, the NRC Personnel Security Review Panel shall make an adverse recommendation. The NRC Personnel Security Review Panel shall prepare a report of its findings and recommendations and submit the report in writing to the Deputy Executive Director for Management Services, who shall furnish a copy to the individual. The findings and recommendations must be fully supported by stated reasons.
(a) The Deputy Executive Director for Management Services, on the basis of the record accompanied by all findings and recommendations, shall make a final determination whether access authorization and/or employment clearance shall be granted, denied, or revoked, except when the provisions of § 10.28 (i), (j), or (l) have been used and the Deputy Executive Director for Management Services determination is adverse, the Commission shall make the final agency determination.
(b) In making the determination as to whether an access authorization and/or an employment clearance shall be granted, denied, or revoked, the Deputy Executive Director for Management Services or the Commission shall give due recognition to the favorable as well as the unfavorable information concerning the individual and shall take into account the value of the individual's services to the NRC's program and the consequences of denying or revoking access authorization and/or employment clearance.
(c) In the event of an adverse determination, the Deputy Executive Director for Management Services shall promptly notify the individual through the Director, Office of Administration, of his or her decision that an access authorization and/or an employment clearance is being denied or revoked and of his or her findings with respect to each allegation contained in the notification letter for transmittal to the individual.
(d) In the event of a favorable determination, the Deputy Executive Director for Management Services shall
(a) Whenever, under the provisions of § 10.28(i), (j), or (l) an individual has not been afforded an opportunity to confront and cross-examine witnesses who have furnished information adverse to the individual and an adverse recommendation has been made by the Deputy Executive Director for Management Services, the Commission shall review the record and determine whether an access authorization and/or an employment clearance should be granted, denied, or revoked, based upon the record.
(b) When the Commission determines to deny or revoke access authorization and/or employment clearance, the individual shall promptly be notified through the Director, Office of Administration, of its decision that access authorization and/or employment clearance is being denied or revoked and of its findings and conclusions with respect to each allegation contained in the notification letter for transmittal to the individual.
(c) Nothing contained in these procedures shall be deemed to limit or affect the responsibility and powers of the Commission to deny or revoke access to Restricted Data or national security information if the security of the nation so requires. Such authority may not be delegated and may be exercised when the Commission determines that invocation of the procedures prescribed in this part is inconsistent with the national security. Such determination shall be conclusive.
(a) Where, pursuant to the procedures set forth in §§ 10.20 through 10.34, the Deputy Executive Director for Management Services or the Commission has made a determination granting an access authorization and/or an employment clearance to an individual, the individual's eligibility for an access authorization and/or an employment clearance will be reconsidered only when subsequent to the time of that determination, new derogatory information has been received or the scope or sensitivity of the Restricted Data or National Security Information to which the individual has or will have access has significantly increased. All new derogatory information, whether resulting from the NRC's reinvestigation program or other sources, will be evaluated relative to an individual's continued eligibility in accordance with the procedures of this part.
(b) Where, pursuant to these procedures, the Commission or Deputy Executive Director for Management Services has made a determination denying or revoking an access authorization and/or an employment clearance to an individual, the individual's eligibility for an access authorization and/or an employment clearance may be reconsidered when there is a bona fide offer of employment and/or a bona fide need for access to Restricted Data or National Security Information and either material and relevant new evidence is presented, which the individual and his or her representatives are without fault in failing to present before, or there is convincing evidence of reformation or rehabilitation. Requests for reconsideration must be submitted in writing to the Deputy Executive Director for Management Services through the Director, Office of Administration. Requests must be accompanied by an affidavit setting forth in detail the information referred to above. The Deputy Executive Director for Management Services shall cause the individual to be notified as to whether his or her eligibility for an access authorization and/or an employment clearance will be reconsidered and if so, the method by which a reconsideration will be accomplished.
(c) Where an access authorization and/or an employment clearance has been granted to an individual by the Director, Division of Facilities and Security, without recourse to the procedures set forth in §§ 10.20 through 10.34, the individual's eligibility for an access authorization and/or an employment clearance will be reconsidered only in a case where, subsequent to the granting of the access authorization
In the event the individual is no longer an applicant for access authorization and/or employment clearance or no longer requires such, the procedures of this part shall be terminated without a final determination as to the individual's eligibility for access authorization and/or employment clearance.
In the event the individual is represented by an attorney or other representative, the individual shall file with the Director, Office of Administration, a document designating such attorney or representative and authorizing such attorney or representative to receive all correspondence, transcripts, and other documents pertaining to the proceeding under this part.
Whenever information is made a part of the record under the exceptions authorized by § 10.28 (i), (j), or (l), the record shall contain certificates evidencing that the required determinations have been made.
Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
Section 11.15(e) also issued under sec. 501, 85 Stat. 290 (31 U.S.C. 483a).
This part establishes the requirements for special nuclear material access authorization, and the criteria and procedures for resolving questions concerning the eligibility of individuals to receive special nuclear material access authorization for conduct of certain activities, licensed or otherwise, which involve access to or control over special nuclear material.
(a) The requirements, criteria, and procedures of this part apply to the establishment of and eligibility for special nuclear material access authorization for employees, contractors, consultants of, and applicants for employment with licensees or contractors of the Nuclear Regulatory Commission. This employment, contract, service, or consultation may involve any duties or assignments within the criteria of § 11.11 or § 11.13 requiring access to, or control over, formula quantities of special nuclear material (as defined in part 73 of this chapter).
(b) The requirements, criteria, and procedures of this part are in addition to and not in lieu of any requirements, criteria, or procedures for access to or control over classified special nuclear material.
It is the policy of the Nuclear Regulatory Commission to carry out its authority to establish and administer, in a manner consistent with traditional American concepts of justice, a personnel security program in the interests of the common defense and security for the purpose of safeguarding special nuclear material and preventing sabotage which would endanger the public by exposure to radiation. To this end, the Commission has established criteria for determining eligibility for special nuclear material access authorization and will afford affected individuals the opportunity for administrative review of questions concerning their eligibility for special nuclear material access authorization.
As used in this part:
Terms defined in parts 10, 25, 50, 70, 72, 73, and 95 of this chapter have the same meaning when used in this part.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0062.
(b) The approved information collection requirements contained in this part appear in §§ 11.9, 11.11, 11.13, 11.15, and 11.16.
The Commission may, upon application of any interested party, grant an exemption from the requirements of this part. Exemptions will be granted only if they are authorized by law and will not constitute an undue risk to
Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawing, specification, must include all pertinent information such as stamps, initials, and signatures etc. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a) Each licensee who uses, processes, stores, transports, or delivers to a carrier for transport, formula quantities of special nuclear material (as defined in part 73 of this chapter) subject to the physical protection requirements of §§ 73.20, 73.25, 73.26, 73.45, and 73.46, and each person subject to the general licensing requirements of § 70.20a, shall identify at its facility or plant (excluding all non-power reactor facilities and storage of fuel incident thereto and facilities and plants in which the licensee possesses or uses only irradiated special nuclear material subject to the exemption of § 73.6(b)), describe, and if not already provided, provide to the Commission, by December 26, 1985 by amendment to its security plan:
(1) All jobs in which an individual could steal or divert special nuclear material, or commit sabotage which would endanger the public by exposure to radiation, by working alone or in cooperation with an individual who does not possess an NRC-U special nuclear material access authorization, or by directing or coercing any individual to assist in the theft, diversion, or sabotage. Such jobs include but are not limited to:
(i) All positions in the licensee's security force,
(ii) Management positions with the authority to:
(A) Direct the actions of members of the security force or alter security procedures, or
(B) Direct routine movements of special nuclear material, or
(C) Direct the routine status of vital equipment.
(iii) All jobs which require unescorted access within onsite alarm stations.
(iv) All jobs which require unescorted access
(2) All jobs which require unescorted access within protected areas and which do not fall within the criterion of paragraph (a)(1) of this section.
(b) After 365 days following Commission approval of the amended security plan submitted in accordance with paragraph (a) of this section, no individual may be permitted to work at any job determined by the Commission to fall within the criterion of paragraph (a)(1) of this section without an NRC-U special nuclear material access authorization, and no individual may be permitted unescorted access to any protected area at any site subject to this part without either an NRC-U or NRC-R special nuclear material access authorization. The exceptions to the requirement for an NRC-U and NRC-R special nuclear material access authorization are as follows:
(1) Exceptions to the requirement for an NRC-U special nuclear material access authorization for an individual to work at a job within the criteria of paragraph (a)(1) are provided for:
(i) Any individual employed in such a job on October 28, 1985, who is not yet in receipt of an NRC-U special nuclear material access authorization from the Commission, provided that a complete application has been submitted to and is pending before the NRC for processing for that employee in accordance with § 11.15 (a) and (b); or
(ii) Any individual in possession of an NRC-L or R access authorization or an equivalent active Federal security clearance but not yet in receipt of the NRC-U special nuclear material access authorization, provided that a complete application has been submitted to and is pending before the NRC for processing for that employee in accordance with § 11.15 (a) or (b), or both.
(2) Exceptions to the requirement for an NRC-R special nuclear material access authorization for an individual to have unescorted access to a protected area are provided for:
(i) Any individual employed in such a job on October 28, 1985 who is not yet in receipt of an NRC-R special nuclear material access authorization from the Commission, provided that a complete application has been submitted to and is pending before the NRC for processing for that employee in accordance with § 11.15 (a) and (b); or
(ii) Any individual in possession of an NRC-L access authorization or an equivalent active Federal security clearance, provided that a complete application has been submitted to the NRC for processing for that employee in accordance with § 11.15 (a) or (b), or both.
(a) All individuals who, after 365 days following approval of the amended security plan submitted in accordance with § 11.11(a), transport, arrange for transport, drive motor vehicles in road shipments of special nuclear material, pilot aircraft in air shipments of special nuclear material, act as monitors at transfer points, or escort road, rail, sea, or air shipments of special nuclear material subject to the appropriate physical protection requirements of §§ 73.20, 73.25, 73.26, or 73.27 of this chapter, or who are authorized to alter the scheduling and routing of such transport shall have NRC-U special nuclear material access authorization. Exceptions are provided for:
(1) Any individual who is employed in such a job on October 28, 1985 and who is not yet in receipt of an NRC-U special nuclear material access authorization from the Commission, provided that a complete application has been submitted to and is pending before the NRC for processing for that employee in accordance with § 11.15 (a) and (b) or
(2) Any individual in possession of an NRC-L or R access authorization or equivalent active Federal security clearance but not yet in receipt of the NRC-U special nuclear material access authorization, provided that a complete application has been submitted to and is pending before the NRC for processing for that employee in accordance with § 11.15 (a) or (b), or both.
(b) Each licensee who, 365 days after Commission approval of the amended security plan submitted in accordance with § 11.11(a), transports or delivers to a carrier for transport special nuclear material subject to the physical protection requirement of §§ 73.20, 73.25, 73.26, or 73.27 of this chapter shall confirm and record prior to shipment the name and special nuclear material access authorization number of all individuals identified in paragraph (a) of this section assigned to the shipment. The licensee shall retain this record for three years after the last shipment is made. However, the licensee need not confirm and record the special nuclear material access authorization number in the case of any individual for whom an application has been submitted and is pending before the NRC in accordance with paragraph (a) of this section.
(a)(1) Application for special nuclear material access authorization, renewal, or change in level must be filed by the licensee on behalf of the applicant with the Director, Division of Facilities and Security, U.S. Nuclear Regulatory
(2) Licensees who wish to secure NRC-U or NRC-R special nuclear material access authorizations for individuals in possession of an active NRC Q or L access authorization or other security clearance granted by another Federal agency based on an equivalent investigation shall submit a “Security Acknowledgment” (NRC Form 176) and a “Request for Access Authorization” (NRC Form 237). NRC will process these requests by verifying the data on an NRC-cleared individual, or by contacting the Federal agency that granted the clearance, requesting certification of the security clearance, and determining the investigative basis and level of the clearance. Licensees may directly request the Federal agency that administered the security clearance, if other than NRC, to certify to the NRC that it has on file an active security clearance for an individual and to specify the investigative basis and level of the clearance.
(b) Applications for special nuclear material access authorization for individuals, other than those qualifying under the provisions of § 11.15(a)(2), must be made on forms supplied by the Commission, including:
(1) Questionnaire for National Security Positions (SF-86, Parts 1 and 2);
(2) Two completed standard fingerprint cards (FD-258);
(3) Security Acknowledgment (NRC Form 176);
(4) Other related forms where specified in accompanying instruction (NRC-254); and
(5) A statement by the employer, prospective employer, or contractor identifying the job to be assigned to or assumed by the individual and the level of authorization needed, justified by appropriate reference to the licensee's security plan.
(c)(1) Except as provided in paragraph (c)(2) of this section, NRC-U special nuclear material access authorizations must be renewed every five years from the date of issuance. Except as provided in paragraph (c)(3) of this section, NRC-R special nuclear material access authorizations must be renewed every ten years from the date of issuance. An application for renewal must be submitted at least 120 days before the expiration of the five-year period for NRC-U and ten-year period for NRC-R, respectively, and must include:
(i) A statement by the licensee that at the time of application for renewal the individual's assigned or assumed job requires an NRC-U or an NRC-R special nuclear material access authorization, justified by appropriate reference to the licensee's security plan;
(ii) The Questionnaire for National Security Positions (SF-86, Parts 1 and 2);
(iii) Two completed standard fingerprint cards (FD-258); and
(iv) Other related forms specified in accompanying NRC instructions (NRC Form 254).
(2) An exception to the time for submission of NRC-U special nuclear material access authorization renewal applications and the paperwork required is provided for individuals who have a current and active DOE-Q access authorization and are subject to DOE Reinvestigation Program requirements. For these individuals, the submission to DOE of the SF-86 pursuant to DOE Reinvestigation Program requirements (generally every five years) will satisfy the NRC renewal submission and paperwork requirements even if less than five years has passed since the date of issuance or renewal of the NRC-U access authorization. Any NRC-U special nuclear material access authorization renewed in response to provisions of this paragraph will not be due for renewal until the date set by DOE for the next reinvestigation of the individual pursuant to DOE's Reinvestigation Program.
(3) An exception to the time for submission of NRC-R special nuclear material access authorization renewal applications and the paperwork required is provided for individuals who have a current and active DOE-L or DOE-Q access authorization and are subject to DOE Reinvestigation Program requirements. For these individuals, the submission to DOE of the SF-86 pursuant
(4) Notwithstanding the provisions of paragraph (c)(2) of this section, the period of time for the initial and each subsequent NRC-U renewal application to NRC may not exceed seven years.
(5) Notwithstanding the provisions of paragraph (c)(3) of this section, the period of time for the initial and each subsequent NRC-R renewal application to NRC may not exceed twelve years. Any individual who is subject to the DOE Reinvestigation Program requirements but, for administrative or other reasons, does not submit reinvestigation forms to DOE within seven years of the previous submission, for a NRC-U renewal or twelve years of the previous submission for a NRC-R renewal, shall submit a renewal application to NRC using the forms prescribed in paragraph (c)(1) of this section before the expiration of the seven year period for NRC-U or twelve year period for NRC-R renewal.
(d) If at any time, due to new assignment or assumption of duties, a change in a special nuclear material access authorization level from NRC “R” to “U” is required, the individual shall apply for a change of level of special nuclear material access authorization. The application must include a description of the new duties to be assigned or assumed, justified by appropriate reference to the licensee's security plan.
(e)(1) Each application for a special nuclear material access authorization, renewal, or change in level must be accompanied by the licensee's remittance, payable to the U.S. Nuclear Regulatory Commission, according to the following schedule:
(2) Material access authorization fees will be published each time the Office of Personnel Management notifies NRC of a change in the background investigation rate it charges NRC for conducting the investigation. Any changed access authorization fees will be applicable to each access authorization request received upon or after the date of publication. Applications from individuals having current Federal access authorizations may be processed expeditiously at no cost because the Commission may accept the certification of access authorizations and investigative data from other Federal government agencies that grant personnel access authorizations.
(f)(1) Any Federal employee, employee of a contractor of a Federal agency, licensee, or other person visiting an affected facility for the purpose of conducting official business, who possesses an active NRC or DOE-Q access authorization or an equivalent Federal security clearance granted by another Federal agency (“Top Secret”) based on a comparable single scope background investigation may be permitted, in accordance with § 11.11, the same level of unescorted access that an NRC-U special nuclear material access authorization would afford.
(2) Any Federal employee, employee of a contractor of a Federal agency, licensee, or other person visiting an affected facility for the purpose of conducting official business, who possesses an active NRC or DOE-L access authorization or an equivalent security clearance granted by another Federal agency (“Secret”) based on a comparable or greater background investigation consisting of a national agency check with law and credit may be permitted, in accordance with § 11.11, the same level of unescorted access that an NRC-R special nuclear material access authorization would afford. An NRC or DOE-L access authorization or an equivalent security clearance (“Secret”), based on a background investigation or national agency check with credit granted or being processed by another Federal agency before January 1, 1998, is acceptable to meet this requirement.
When a request for an individual's access authorization is withdrawn or canceled, the licensee shall notify the Chief, Personnel Security Branch, NRC Division of Facilities and Security immediately, by telephone, so that the investigation may be discontinued. The caller shall provide the full name and date of birth of the individual, the date of request, and the type of access authorization originally requested (“U” or “R”). The licensee shall promptly submit written confirmation of the telephone notification to the Personnel Security Branch, NRC Division of Facilities and Security. A portion of the fee for the “U” special nuclear material access authorization may be refunded depending upon the status of the single scope investigation at the time of withdrawal or cancellation.
(a) The decision to grant or deny special nuclear material access authorization is a comprehensive, common-sense judgment, made after consideration of all the relevant information, favorable or unfavorable, that to grant or deny special nuclear material access authorization is or is not inimical to the common defense and security and is or is not clearly consistent with the national interest.
(b) To assist in making these determinations, on the basis of all the information in a particular case, there are set forth in § 10.11 of this chapter a number of specific types of derogatory information. These criteria are not exhaustive but contain the principal types of derogatory information which in the opinion of the Commission create a question as to the individual's eligibility for special nuclear material access authorization. These criteria are subject to continuing review and may be revised from time to time as experience and circumstances may make desirable.
(c) When the reports of an investigation of an individual contain information reasonably falling within one or more of the classes of derogatory information listed in § 10.11, it creates a question as to the individual's eligibility for special nuclear material access authorization. In these cases, the application of the criteria must be made in light of and with specific regard to whether the existence of the information supports a reasonable belief that the granting of a special nuclear material access authorization would be inimical to the common defense and security. The Director, Division of Facilities and Security, may authorize the granting of a special nuclear material access authorization on the basis of the information in the case or may authorize the conduct of an interview with the individual and, on the basis of the interview and other investigation as the Director deems appropriate, may authorize the granting of a special nuclear material access authorization. Otherwise, a question concerning the eligibility of an individual for a special nuclear material access authorization must be resolved in accordance with the procedures set forth in §§ 10.20 through 10.38 of this chapter.
(d) In resolving a question concerning the eligibility or continued eligibility of an individual for a special nuclear
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all regulations in part 11 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 11 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 11.1, 11.3, 11.5, 11.7, 11.8, 11.9, 11.16, 11.21, 11.30, and 11.32.
Sec. 203(a)(1), Pub. L. 96-481, 94 Stat. 2325 (5 U.S.C. 504(c)(1)); Pub. L. 99-80, 99 Stat. 183.
The purpose of this part is to state the regulatory requirements for award of attorney fees to eligible individuals and entities in certain administrative proceedings before the Nuclear Regulatory Commission, in implementation of the Equal Access to Justice Act, 5 U.S.C. 504 (EAJA), which provides for the award of attorney fees and other expenses to parties to “adversary adjudications”, as defined in 5 U.S.C. 504(b)(1)(C). In general, an “adversary adjudication” is an adjudication that is required by statute to be determined on the record after opportunity for hearing before an agency of the United States and in which the position of the agency, or any component of the agency, is presented by an attorney or other representative who enters an appearance and participates in the proceeding. However, some agency adjudications are expressly excluded from coverage by 5 U.S.C. 504 (e.g., an adjudication for the purpose of granting or renewing a license) even though they fall within this general definition, and certain appeals before an agency board of contract appeals and Program Fraud Civil Remedies Act hearings conducted under 31 U.S.C. ch. 38 are expressly covered.
An eligible party may receive an award in an adversary adjudication when the party prevails over the Commission, unless the Commission's position was substantially justified or special circumstances make an award unjust. The regulations in this part describe the parties eligible for awards and the proceedings that are covered. They also explain how to apply for awards, and the procedures and standards that the Commission will use to make them.
The EAJA applies to any covered adversary adjudication pending or commenced before the Commission on or after August 5, 1985.
(a) The EAJA applies to the following proceedings:
(1) Hearings under the Program Fraud Civil Remedies Act (31 U.S.C. 3801-12);
(2) Any appeal of a decision made pursuant to section 6 of the Contract Disputes Act of 1978 (41 U.S.C. 605) before an agency board of contract appeals as provided in section 8 of that Act (41 U.S.C. 607); and
(3) Adversary adjudications conducted by the Commission pursuant to any other statutory provision that requires a proceeding before the Nuclear Regulatory Commission to be so conducted as to fall within the meaning of “adversary adjudication” under 5 U.S.C. 504(b)(1)(C).
(b) The Commission's failure to identify a type of proceeding as an adversary adjudication shall not preclude the filing of an application by a party who believes the proceeding is covered by the EAJA. Whether the proceeding is covered will then be an issue for resolution in proceedings on the application.
(c) If a proceeding includes both matters covered by the EAJA and matters specifically excluded from coverage, any award made will include only fees and expenses related to covered issues.
(a) To be eligible for an award of attorney fees and other expenses under the EAJA, the applicant must be a party to the adversary adjudication for which it seeks an award. The term “party” is defined in 5 U.S.C. 551(3). The applicant must show that it meets all conditions of eligibility set out in this subpart and in subpart B.
(b) The types of eligible applicants are as follows:
(1) An individual with a net worth of not more than $2 million;
(2) The sole owner of an unincorporated business who has a net worth of not more than $7 million, including both personal and business interests, and not more than 500 employees;
(3) A charitable or other tax-exempt organization described in section
(4) A cooperative association as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)) with not more than 500 employees; and
(5) Any other partnership, corporation, association, unit of local government, or organization with a net worth of not more than $7 million and not more than 500 employees.
(c) For the purpose of eligibility, the net worth and number of employees of an applicant shall be determined as of the date the proceeding was initiated.
(d) An applicant who owns an unincorporated business will be considered as an “individual” rather than a “sole owner of an unincorporated business” if the issues on which the applicant prevails are related primarily to personal interests rather than to business interests.
(e) The employees of an applicant include all persons who regularly perform services for remuneration for the applicant, under the applicant's direction and control. Part-time employees shall be included on a proportional basis.
(f) The net worth and number of employees of the applicant and all of its affiliates shall be aggregated to determine eligibility. Any individual, corporation, or other entity that directly or indirectly controls or owns a majority of the voting shares or other interests of the applicant, or any corporation or other entity of which the applicant directly or indirectly owns or controls a majority of the voting shares or other interest, will be considered an affiliate for purposes of this part, unless the adjudicative officer determines that such treatment would be unjust and contrary to the purposes of the Act in light of the actual relationship between the affiliated entities. In addition, the adjudicative officer may determine that financial relationships of the applicant other than those described in this paragraph constitute special circumstances that would make an award unjust.
(g) An applicant that participates in a proceeding primarily on behalf of one or more other persons or entities that would be ineligible is not itself eligible for an award.
(a) A prevailing applicant may receive an award for fees and expenses incurred in connection with a proceeding or a significant and discrete substantive portion of the proceeding, unless the position of the Commission over which the applicant has prevailed was substantially justified. The position of the Commission includes, in addition to the position taken by the Commission in the adversary adjudication, the action or failure to act by the Commission upon which the adversary adjudication is based. The burden of proof that an award should not be made to a prevailing applicant because the Commission's position was substantially justified is on the Commission counsel.
(b) An award will be reduced or denied if the applicant has unduly or unreasonably protracted the proceeding or if special circumstances make the award sought unjust.
(a) Awards will be based on rates customarily charged by persons engaged in the business of acting as attorneys, agents, and expert witnesses, even if the services were made available without charge or at reduced rate to the applicant.
(b) No award for the fee of an attorney or agent under this part may exceed $75.00 per hour. No award to compensate an expert witness may exceed the highest rate at which the Commission pays expert witnesses. However, an award may also include the reasonable expenses of the attorney, agent, or witness as a separate item, if the attorney, agent, or witness ordinarily charges clients separately for these expenses.
(c) In determining the reasonableness of the fee sought for an attorney, agent, or expert witness, the adjudicative officer shall consider the following:
(1) If the attorney, agent, or witness is in private practice, his or her customary fees for similar services, or, if an employee of the applicant, the fully allocated costs of the services;
(2) The prevailing rate for similar services in the community in which the attorney, agent, or witness ordinarily performs services;
(3) The time actually spent in the representation of the applicant;
(4) The time reasonably spent in light of the difficulty or complexity of the issues in the proceeding; and
(5) Other factors that bear on the value of the services provided.
(d) The reasonable cost of any study, analysis, engineering report, test, project, or similar matter prepared on behalf of a party may be awarded, to the extent that the charge for the services does not exceed the prevailing rate for similar services, and the study or other matter was necessary for preparation of applicant's case.
(a) If warranted by an increase in the cost of living or by special circumstances (such as limited availability of attorneys qualified to handle certain types of proceedings), the Commission may adopt regulations providing that attorney fees may be awarded at a rate higher than $75 per hour in some, or all of the types of proceedings covered by this part. The Commission will conduct any rulemaking proceedings for this purpose under the informal rulemaking procedures of the Administrative Procedure Act.
(b) Any person may file with the Commission a petition for rulemaking to increase the maximum rate for attorney fees, in accordance with the requirements of 10 CFR 2.802. The petition should identify the rate the petitioner believes the Commission should establish and the types of proceedings in which the rate should be used. It should also explain fully the reasons why the higher rate is warranted. Within 90 days after the petition is filed, the Commission will determine whether it will initiate a rulemaking proceeding, deny the petition, or take other appropriate action on the petition. The Commission will act on the petition in accordance with 10 CFR 2.803.
If an applicant is entitled to an award because it prevails over another agency of the United States that participates in a proceeding before the Commission and takes a position that is not substantially justified, the award or an appropriate portion of the award shall be made against that agency.
Unless otherwise ordered by the Commission in a particular proceeding, each application under this part shall be assigned for decision to the official or decisionmaking body that entered the decision in the adversary adjudication. That official or decisionmaking body is referred to in this part as the “adjudicative officer.”
(a) An application for an award of fees and expenses under the EAJA shall identify the applicant and the proceeding for which an award is sought. The application shall show that the applicant has prevailed and identify the position of the Commission or other agency that the applicant alleges was not substantially justified. Unless the applicant is an individual, the application shall also state the number of employees of the applicant and describe briefly the type and purpose of its organization or business.
(b) The application shall also include a statement that the applicant's net worth does not exceed $2 million (if an individual) or $7 million (for all other applicants, including their affiliates). However, an applicant may omit this statement if:
(1) The applicant attaches a copy of a ruling by the Internal Revenue Service that it qualifies as an organization described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) or, in the case of a tax-exempt organization not required to obtain a ruling from the Internal Revenue Service on
(2) The applicant states that it is a cooperative association as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)).
(c) The application shall state the amount of fees and expenses for which an award is sought.
(d) The application may also include any other matters that the applicant wishes the Commission to consider in determining whether, and in what amount, an award should be made.
(e) The application shall be signed by the applicant or an authorized officer or attorney of the applicant. It shall also contain or be accompanied by a written verification under oath or under penalty of perjury that the information provided in the application is true and correct.
(a) Each applicant, except a qualified tax-exempt organization or cooperative association must provide with its application a detailed exhibit showing the net worth of the applicant and any affiliates (as defined in § 12.104(f) of this part) when the proceeding was initiated. The exhibit may be in any form convenient to the applicant that provides full disclosure of the applicant's and its affiliates’ assets and liabilities and is sufficient to determine whether the applicant qualifies under the standards in this part. The adjudicative officer may require an applicant to file additional information to determine its eligibility for an award.
(b) Ordinarily, the net worth exhibit will be included in the public record of the proceeding. However, an applicant that objects to public disclosure of information in any portion of the exhibit and believes there are legal grounds for withholding it from disclosure may submit that portion of the exhibit directly to the adjudicative officer in a sealed envelope labeled “Confidential Financial Information,” accompanied by a motion to withhold the information from public disclosure. The motion shall describe the information sought to be withheld and explain, in detail, why it falls within one or more of the specific exemptions from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b)(1)-(9), why public disclosure of the information would adversely affect the applicant, and why disclosure is not required in the public interest. The material in question shall be served on counsel representing the agency against which the applicant seeks an award, but need not be served on any other party to the proceeding. If the adjudicative officer finds that the information should not be withheld from disclosure, it shall be placed in the public record of the proceeding. Otherwise, any request to inspect or copy the exhibit shall be disposed of in accordance with the Commission's established procedures under the Freedom of Information Act, 10 CFR part 9, subpart A.
The application shall be accompanied by full documentation of the fees and expenses, including the cost of any study, analysis, engineering report, test, project, or similar matter for which an award is sought. A separate itemized statement shall be submitted for each professional firm or individual whose services are covered by the application, showing the hours spent in connection with the proceeding by each individual, a description of the specific services performed, the rates at which each fee has been computed, any expenses for which reimbursement is sought, the total amount claimed, and the total amount paid or payable by the applicant or by any other person or entity for the services provided. The adjudicative officer may require the applicant to provide vouchers, receipts, logs, or other substantiation for any fees or expenses claimed, pursuant to § 12.306 of this part.
(a) An application may be filed whenever the applicant has prevailed in the proceeding or in a significant and discrete substantive portion of the proceeding, but in no case later than 30 days after the date on which a decision or order disposing of the merits of the
(b) If after the filing of an application for an award, review or reconsideration is sought or taken of a decision as to which an applicant believes it has prevailed, proceedings for the award of fees shall be stayed pending final disposition of the underlying controversy. When the United States appeals the underlying merits of an adversary adjudication to a court, no decision on an application for fees and other expenses in connection with that adversary adjudication shall be made until a final and unreviewable decision is rendered by the court on the appeal or until the underlying merits of the case have been finally determined pursuant to the appeal.
Any application for an award or other pleading or document related to an application shall be filed and served on all parties to the proceeding in the same manner as other pleadings in the proceeding, except as provided in § 12.202(b) for confidential financial information.
(a) Within 30 days after service of an application, counsel representing the NRC against which an award is sought may file an answer to the application. Unless the NRC counsel requests an extension of time for filing or files a statement of intent to negotiate under paragraph (b) of this section, failure to file an answer within the 30-day period may be treated as a consent to the award requested.
(b) If the NRC counsel and the applicant believe that the issues in the fee application can be settled, they may jointly file a statement of their intent to negotiate a settlement. The filing of this statement shall extend the time for filing an answer for an additional 30 days, and further extensions may be granted by the adjudicative officer upon request by the NRC counsel and the applicant.
(c) The answer shall explain in detail any objections to the award requested and identify the facts relied on in support of the NRC counsel's position. If the answer is based on any alleged facts not already in the record of the proceeding, the NRC counsel shall include with the answer either supporting affidavits or a request for further proceedings under § 12.306.
Within 15 days after service of an answer, the applicant may file a reply. If the reply is based on any alleged facts not already in the record of the proceeding, the applicant shall include with the reply either supporting affidavits or a request for further proceedings under § 12.306.
Any party to a proceeding other than the applicant and the NRC counsel may file comments on an application within 30 days after it is served, or on an answer within 15 days after it is served. A commenting party may not participate further in proceedings on the application unless the adjudicative officer determines that the public interest requires participation in order to permit full exploration of matters raised in the comments.
The applicant and the NRC counsel may agree on a proposed settlement of the award before final action on the application, either in connection with a settlement of the underlying proceeding, or after the underlying proceeding has been concluded, in accordance with the NRC's standard settlement procedure. If a prevailing party and the NRC's counsel agree on a proposed settlement of an award before an application has been filed, the application shall be filed with the proposed settlement.
(a) Ordinarily, the determination of an award will be made on the basis of the written record. However, on request of either the applicant or the
(b) A request that the adjudicative officer order further proceedings under this section shall specifically identify the information sought or the disputed issues and shall explain why the additional proceedings are necessary to resolve the issues.
(a) The adjudicative officer shall issue an initial decision on the application within 90 days after completion of proceedings on the application. If the adjudicative officer fails to issue an initial decision within 90 days, he or she shall notify the parties of the reason for the delay and shall set a new deadline.
(b) The initial decision shall include written findings and conclusions on the applicant's eligibility and status as a prevailing party, and an explanation of the reasons for any difference between the amount requested and the amount awarded. The decision shall also include, if at issue, findings on whether the NRC's position was substantially justified, whether the applicant unduly protracted the proceedings, or whether special circumstances make an award unjust. If the applicant has sought an award against more than one agency, the decision shall allocate responsibility for payment of any award made among the agencies, and shall explain the reasons for the allocation made.
(a) Either the applicant or the NRC counsel may seek review of the initial decision on the fee application, or the Commission may decide to review the decision on its own initiative, in accordance with the Commission's review procedures set out in 10 CFR 2.786. The filing of a petition for review is mandatory for a party to exhaust its administrative remedies before seeking judicial review. If neither the applicant nor NRC counsel seeks review and the Commission does not take review on its own initiative, the initial decision on the application shall become a final decision of the NRC forty (40) days after it is issued.
(b) Notwithstanding anything to the contrary in any other part of the Commission's regulations, the initial decision shall be inoperative (i.e., the decision shall not be final and any award made shall not be paid) until the later of—
(1) The expiration of the forty-day period provided in paragraph (a) of this section; or
(2) If within the forty-day period provided in paragraph (a) of this section the Commission elects to review the decision, the Commission's issuance of a final decision on review of the initial decision.
(c) Whether to review a decision on its own motion is a matter within the discretion of the Commission. If review is taken, the Commission will issue a final decision on the application or remand the application to the adjudicative officer for further proceedings.
Judicial review of final agency decisions on awards may be sought as provided in 5 U.S.C. 504(c)(2).
An applicant seeking payment of an award shall submit to the appropriate official of the paying agency a copy of the Commission's final decision granting the award, accompanied by a certification that the applicant will not seek review of the decision in the United States courts. Where the award is granted against the Commission, the applicant shall make the submission to the Director, Division of Accounting
Public Law 99-509, secs. 6101-6104, 100 Stat. 1874 (31 U.S.C. 3801-3812). Sections 13.13 (a) and (b) also issued under section Pub. L. 101-410, 104 Stat. 890, as amended by section 31001(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note).
(a)
(b)
As used in this part:
(a) Made to the authority for property, services, or money (including money representing grants, loans, insurance, or benefits);
(b) Made to a recipient of property, services, or money from the authority or to a party to a contract with the authority—
(1) For property or services if the United States—
(i) Provided such property or services;
(ii) Provided any portion of the funds for the purchase of such property or services; or
(iii) Will reimburse such recipient or party for the purchase of such property or services; or
(2) For the payment of money (including money representing grants, loans, insurance, or benefits) if the United States—
(i) Provided any portion of the money requested or demanded; or
(ii) Will reimburse such recipient or party for any portion of the money paid on such request or demand; or
(c) Made to the authority which has the effect of decreasing an obligation to pay or account for property, services, or money.
(a) Has actual knowledge that the claim or statement is false, fictitious, or fraudulent;
(b) Acts in deliberate ignorance of the truth or falsity of the claim or statement; or
(c) Acts in reckless disregard of the truth or falsity of the claim or statement.
(a) Not subject to supervision by, or required to report to, the investigating official;
(b) Not employed in the organizational unit of the authority in which the investigating official is employed; and
(c) Serving in a position for which the rate of basic pay is not less than the minimum rate of basic pay for grade GS-16 under the General Schedule.
(a) With respect to a claim or to obtain the approval or payment of a claim (including relating to eligibility to make a claim); or
(b) With respect to (including relating to eligibility for)—
(1) A contract with, or a bid or proposal for a contract with; or
(2) A grant, loan, or benefit from, the authority, or any State, political subdivision of a State, or other party, if the United States government provides any portion of the money or property under such contract or for such grant, loan, or benefit, or if the Government will reimburse such State, political subdivision, or party for any portion of the money or property under such contract or for such grant, loan, or benefit.
(a)
(i) Is false, fictitious, or fraudulent;
(ii) Includes or is supported by any written statement which asserts a material fact which is false, fictitious, or fraudulent;
(iii) Includes or is supported by any written statement that—
(A) Omits a material fact;
(B) Is false, fictitious, or fraudulent as a result of such omission; and (C) Is a statement in which the person making such statement has a duty to include such material fact; or
(iv) Is for payment for the provision of property or services which the person has not provided as claimed, shall be subject, in addition to any other remedy that may be prescribed by law, to a civil penalty of not more than $6,000 for each such claim.
(2) Each voucher, invoice, claim form, or other individual request or demand for property, services, or money constitutes a separate claim.
(3) A claim shall be considered made to the authority, recipient, or party when such claim is actually made to an agent, fiscal intermediary or other entity, including any State or political subdivision thereof, acting for or on behalf of the authority, recipient, or party.
(4) Each claim for property, services, or money is subject to a civil penalty regardless of whether such property, services, or money is actually delivered or paid.
(5) If the Government has made any payment (including transferred property or provided services) on a claim, a person subject to a civil penalty under paragraph (a)(1) of this section shall also be subject to an assessment of not more than twice the amount of such claim or that portion thereof that is determined to be in violation of paragraph (a)(1) of this section. Such assessment shall be in lieu of damages sustained by the Government because of such claim.
(b)
(i) The person knows or has reason to know—
(A) Asserts a material fact which is false, fictitious, or fraudulent; or
(B) Is false, fictitious, or fraudulent because it omits a material fact that the person making the statement has a duty to include in such statement; and
(ii) Contains or is accompanied by an express certification or affirmation of the truthfulness and accuracy of the contents of the statement, shall be subject, in addition to any other remedy that may be prescribed by law, to a civil penalty of not more than $6,000 for each such statement.
(2) Each written representation, certification, or affirmation constitutes a separate statement.
(3) A statement shall be considered made to the authority when such statement is actually made to an agent, fiscal intermediary, or other entity, including any State or political subdivision thereof, acting for or on behalf of the authority.
(c) No proof of specific intent to defraud is required to establish liability under this section.
(d) In any case in which it is determined that more than one person is liable for making a claim or statement under this section, each such person may be held liable for a civil penalty under this section.
(e) In any case in which it is determined that more than one person is liable for making a claim under this section on which the Government has made payment (including transferred property or provided services), an assessment may be imposed against any such person or jointly and severally against any combination of such persons.
(a) If an investigating official concludes that a subpoena pursuant to the authority conferred by 31 U.S.C. 3804(a) is warranted—
(1) The subpoena so issued shall notify the person to whom it is addressed of the authority under which the subpoena is issued and shall identify the records or documents sought;
(2) The investigating official may designate a person to act on his or her behalf to receive the documents sought; and
(3) The person receiving such subpoena shall be required to tender to the
(b) If the investigating official concludes that an action under the Program Fraud Civil Remedies Act may be warranted, the investigating official shall submit a report containing the findings and conclusions of such investigation to the reviewing official. To the extent possible, before initiating an investigation or submitting a report involving a licensee false statement to the reviewing official, the investigating official shall consult with the Executive Director for Operations to ascertain whether any other agency action is under consideration, pending, or may be taken with regard to the licensee, and to allow for coordination between any action under this part and other enforcement action.
(c) Nothing in this section shall preclude or limit an investigating official's discretion to refer allegations directly to the Department of Justice for suit under the False Claims Act or other civil relief, or to refer the matter to the Executive Director for Operations for enforcement action under the Atomic Energy Act, or to defer initiating an investigation or postpone a report or referral to the reviewing official to avoid interference with other enforcement action by the Commission or with a criminal investigation or prosecution.
(d) Nothing in this section modifies any responsibility of an investigating official to report violations of criminal law to the Attorney General.
(a) If, based on the report of the investigating official under § 13.4(b), the reviewing official determines that there is adequate evidence to believe that a person is liable under § 13.3 of this part, the reviewing official shall transmit to the Attorney General a written notice of the reviewing official's intention to issue a complaint under § 13.7.
(b) Such notice shall include—
(1) A statement of the reviewing official's reasons for issuing a complaint;
(2) A statement specifying the evidence that supports the allegations of liability;
(3) A description of the claims or statements upon which the allegations of liability are based;
(4) An estimate of the amount of money or the value of property, services, or other benefits requested or demanded in violation of § 13.3 of this part;
(5) A statement of any exculpatory or mitigating circumstances that may relate to the claims or statements known by the reviewing official or the investigating official; and
(6) A statement that there is a reasonable prospect of collecting an appropriate amount of penalties and assessments.
(a) The reviewing official may issue a complaint under § 13.7 only if—
(1) The Department of Justice approves the issuance of a complaint in a written statement described in 31 U.S.C. 3803(b)(1), and
(2) In the case of allegations of liability under § 13.3(a) with respect to a claim, the reviewing official determines that, with respect to such claim or a group of related claims submitted at the same time such claim is submitted (as defined in paragraph (b) of this section), the amount of money or the value of property or services demanded or requested in violation of § 13.3(a) does not exceed $150,000.
(b) For the purposes of this section, a related group of claims submitted at the same time shall include only those claims arising from the same transaction (
(c) Nothing in this section shall be construed to limit the reviewing official's authority to join in a single complaint against a person claims that are unrelated or were not submitted simultaneously, regardless of the amount of
(a) On or after the date the Department of Justice approves the issuance of a complaint in accordance with 31 U.S.C. 3803(b)(1), the reviewing official may serve a complaint on the defendant, as provided in § 13.8.
(b) The complaint shall state—
(1) The allegations of liability against the defendant, including the statutory basis for liability, an identification of the claims or statements that are the basis for the alleged liability, and the reasons why liability allegedly arises from such claims or statements;
(2) The maximum amount of penalties and assessments for which the defendant may be held liable;
(3) Instructions for filing an answer to request a hearing, including a specific statement of the defendant's right to request a hearing by filing an answer and to be represented by a representative; and
(4) That failure to file an answer within 30 days of service of the complaint will result in the imposition of the maximum amount of penalties and assessments without right to appeal, as provided in § 13.10.
(c) At the same time the reviewing official serves the complaint, he or she shall serve the defendant with a copy of these regulations.
(a) Service of a complaint must be made by certified or registered mail or by delivery in any manner authorized by Rule 4(d) of the Federal Rules of Civil Procedure. Service is complete under receipt.
(b) Proof of service, stating the name and address of the person on whom the complaint was served, and the manner and date of service, may be made by—
(1) Affidavit of the individual serving the complaint by delivery;
(2) A United States Postal Service return receipt card acknowledging receipt; or
(3) Written acknowledgment of receipt by the defendant or his or her representative.
(a) The defendant may request a hearing by filing an answer with the reviewing official within 30 days of service of the complaint. Service of an answer shall be made by delivering a copy to the reviewing official or by placing a copy in the United States mail, postage prepaid and addressed to the reviewing official. An answer shall be deemed to be a request for hearing.
(b) In the answer, the defendant—
(1) Shall admit or deny each of the allegations of liability made in the complaint;
(2) Shall state any defense on which the defendant intends to rely;
(3) May state any reasons why the defendant contends that the penalties and assessments should be less than the statutory maximum; and
(4) Shall state the name, address, and telephone number of the person authorized by the defendant to act as defendant's representative, if any.
(c) If the defendant is unable to file an answer meeting the requirements of paragraph (b) of this section within the time provided, the defendant may, before the expiration of 30 days from service of the complaint, file with the reviewing official a general answer denying liability and requesting a hearing, and a request for an extension of time within which to file an answer meeting the requirements of paragraph (b) of this section. The reviewing official shall file promptly with the ALJ the complaint, the general answer denying liability, and the request for an extension of time as provided in § 13.11. For good cause shown, the ALJ may grant the defendant up to 30 additional days within which to file an answer meeting the requirements of paragraph (b) of this section.
(a) If the defendant does not file an answer within the time prescribed in § 13.9(a), the reviewing official may refer the complaint to the ALJ.
(b) Upon the referral of the complaint, the ALJ shall promptly serve on defendant in the manner prescribed in § 13.8 a notice that an initial decision will be issued under this section.
(c) The ALJ shall assume the facts alleged in the complaint to be true, and, if such facts establish liability under § 13.3, the ALJ shall issue an initial decision imposing the maximum amount of penalties and assessments allowed under the statute.
(d) Except as otherwise provided in this section, by failing to file a timely answer, the defendant waives any right to further review of the penalties and assessments imposed under paragraph (c) of this section and the initial decision shall become final and binding upon the parties 30 days after it is issued.
(e) If, before such an initial decision becomes final, the defendant files a motion with the ALJ seeking to reopen on the grounds that extraordinary circumstances prevented the defendant from filing an answer, the initial decision shall be stayed pending the ALJ's decision on the motion.
(f) If, on such motion, the defendant can demonstrate extraordinary circumstances excusing the failure to file a timely answer, the ALJ shall withdraw the initial decision in paragraph (c) of this section if such a decision has been issued, and shall grant the defendant an opportunity to answer the complaint.
(g) A decision of the ALJ denying a defendant's motion under paragraph (e) of this section is not subject to reconsideration under § 13.38.
(h) The defendant may appeal to the authority head the decision denying a motion to reopen by filing a notice of appeal with the authority head within 15 days after the ALJ denies the motion. The timely filing of a notice of appeal shall stay the initial decision until the authority head decides the issue.
(i) If the defendant files a timely notice of appeal with the authority head, the ALJ shall forward the record of the proceeding to the authority head.
(j) The authority head shall decide expeditiously whether extraordinary circumstances excuse the defendant's failure to file a timely answer based solely on the record before the ALJ.
(k) If the authority head decides that extraordinary circumstances excused the defendant's failure to file a timely answer, the authority head shall remand the case to the ALJ with instructions to grant the defendant an opportunity to answer.
(l) If the authority head decides that the defendant's failure to file a timely answer is not excused, the authority head shall reinstate the initial decision of the ALJ, which shall become final and binding upon the parties 30 days after the authority head issues such decision.
Upon receipt of an answer, the reviewing official shall file the complaint and answer with the ALJ.
(a) When the ALJ receives the complaint and answer, the ALJ shall promptly serve a notice of hearing upon the defendant in the manner prescribed by § 13.8. At the same time, the ALJ shall send a copy of such notice to the representative of the authority.
(b) Such notice shall include—
(1) The tentative time and place, and the nature of the hearing;
(2) The legal authority and jurisdiction under which the hearing is to be held;
(3) The matters of fact and law to be asserted;
(4) A description of the procedures for the conduct of the hearing;
(5) The name, address, and telephone number of the representative of the authority and of the defendant, if any; and
(6) Such other matters as the ALJ deems appropriate.
(a) The parties to the hearing shall be the defendant and the authority.
(b) Pursuant to 31 U.S.C. 3730(c)(5), a private plaintiff under the False Claims Act may participate in these proceedings to the extent authorized by the provisions of that Act.
(a) The investigating official, the reviewing official, and any employee or agent of the authority who takes part in investigating, preparing, or presenting a particular case may not, in such case or a factually related case—
(1) Participate in the hearing as the ALJ;
(2) Participate or advise in the initial decision or the review of the initial decision by the authority head, except as a witness or a representative in public proceedings; or
(3) Make the collection of penalties and assessments under 31 U.S.C. 3806.
(b) The ALJ shall not be responsible to, or subject to the supervision or direction of, the investigating official or the reviewing official.
(c) Except as provided in paragraph (a) of this section, the representative for the Government may be employed anywhere in the authority, including in the offices of either the investigating official or the reviewing official.
No party or person (except employees of the ALJ's office) shall communicate in any way with the ALJ on any matter at issue in a case, unless on notice and opportunity for all parties to participate. This provision does not prohibit a person or party from inquiring about the status of a case or asking routine questions concerning administrative functions or procedures.
(a) A reviewing official or ALJ in a particular case may disqualify himself or herself at any time.
(b) A party may file with the ALJ a motion for disqualification of a reviewing official or an ALJ. Such motion shall be accompanied by an affidavit alleging personal bias or other reason for disqualification.
(c) Such motion and affidavit shall be filed promptly upon the party's discovery of reasons requiring disqualification, or such objections, shall be deemed waived.
(d) Such affidavit shall state specific facts that support the party's belief that personal bias or other reason for disqualification exists and the time and circumstances of the party's discovery of such facts. It shall be accompanied by a certificate of the representative of record that it is made in good faith.
(e) Upon the filing of such a motion and affidavit, the ALJ shall proceed no further in the case until he or she resolves the matter of disqualification in accordance with paragraph (f) of this section.
(f)(1) If the ALJ determines that a reviewing official is disqualified, the ALJ shall dismiss the complaint without prejudice.
(2) If the ALJ disqualifies himself or herself, the case shall be reassigned promptly to another ALJ.
(3) If the ALJ denies a motion to disqualify, the authority head may determine the matter only as part of its review of the initial decision upon appeal, if any.
Except as otherwise limited by this part, all parties may—
(a) Be accompanied, represented, and advised by a representative;
(b) Participate in any conference held by the ALJ;
(c) Conduct discovery;
(d) Agree to stipulation of fact or law, which shall be made part of the record;
(e) Present evidence relevant to the issues at the hearing;
(f) Present and cross-examine witnesses;
(g) Present oral arguments at the hearing as permitted by the ALJ; and
(h) Submit written briefs and proposed findings of fact and conclusions of law after the hearing.
(a) The ALJ shall conduct a fair and impartial hearing, avoid delay, maintain order, and assure that a record of the proceeding is made.
(b) The ALJ has the authority to—
(1) Set and change the date, time, and place of the hearing upon reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a reasonable period of time;
(3) Hold conferences to identify or simplify the issues, or to consider other matters that may aid in the expeditious disposition of the proceeding;
(4) Administer oaths and affirmations;
(5) Issue subpoenas requiring the attendance of witnesses and the production of documents at depositions or at hearings;
(6) Rule on motions and other procedural matters;
(7) Regulate the scope and timing of discovery;
(8) Regulate the course of the hearing and the conduct of representatives and parties;
(9) Examine witnesses;
(10) Receive, rule on, exclude, or limit evidence;
(11) Upon motion of a party, take official notice of facts;
(12) Upon motion of a party, decide cases, in whole or in part, by summary judgment where there is no disputed issue of material fact;
(13) Conduct any conference, argument, or hearing on motions in person or by telephone; and
(14) Exercise such other authority as is necessary to carry out the responsibilities of the ALJ under this part.
(c) The ALJ does not have the authority to find Federal statutes or regulations invalid.
(a) The ALJ may schedule prehearing conferences as appropriate.
(b) Upon the motion of any party, the ALJ shall schedule at least one prehearing conference at a reasonable time in advance of the hearing.
(c) The ALJ may use prehearing conferences to discuss the following:
(1) Simplification of the issues;
(2) The necessity or desirability of amendments to the pleadings, including the need for a more definite statement;
(3) Stipulations and admissions of fact or as to the contents and authenticity of documents;
(4) Whether the parties can agree to submission of the case on a stipulated record;
(5) Whether a party chooses to waive appearance at an oral hearing and to submit only documentary evidence (subject to the objection of other parties) and written argument;
(6) Limitation of the number of witnesses;
(7) Scheduling dates for the exchange of witness lists and of proposed exhibits;
(8) Discovery;
(9) The time and place for the hearing; and
(10) Such other matters as may tend to expedite the fair and just disposition of the proceedings.
(d) The ALJ may issue an order containing all matters agreed upon by the parties or ordered by the ALJ at a prehearing conference.
(a) Upon written request to the reviewing official, the defendant may review any relevant and material documents, transcripts, records, and other materials that relate to the allegations set out in the complaint and upon which the findings and conclusions of the investigating official under § 13.4(b) are based, unless such documents are subject to a privilege under Federal law. Upon payment of fees for duplication, the defendant may obtain copies of such documents.
(b) Upon written request to the reviewing official, the defendant also may obtain a copy of all exculpatory information in the possession of the reviewing official or investigating official relating to the allegations in the complaint, even if it is contained in a document that would otherwise be privileged. If the document would otherwise be privileged, only that portion containing exculpatory information must be disclosed.
(c) The notice sent to the Attorney General from the reviewing official as described in § 13.5 is not discoverable under any circumstances.
(d) The defendant may file a motion to compel disclosure of the documents subject to the provisions of this section. Such a motion may only be filed with the ALJ following the filing of an answer pursuant to § 13.9.
(a) The following types of discovery are authorized:
(1) Requests for production of documents for inspection and copying;
(2) Requests for admissions of the authenticity of any relevant document or of the truth of any relevant fact;
(3) Written interrogatories; and
(4) Depositions.
(b) For the purpose of this section and §§ 13.22 and 13.23, the term “documents” includes information, documents, reports, answers, records, accounts, papers, and other data and documentary evidence. Nothing contained herein shall be interpreted to require the creation of a document.
(c) Unless mutually agreed to by the parties, discovery is available only as ordered by the ALJ. The ALJ shall regulate the timing of discovery.
(d)
(1) A party seeking discovery may file a motion with the ALJ. Such a motion shall be accompanied by a copy of the requested discovery, or in the case of depositions, a summary of the scope of the proposed deposition.
(2) Within ten days of service, a party may file an opposition to the motion and/or a motion for protective order as provided in § 13.24.
(3) The ALJ may grant a motion for discovery only if he or she finds that the discovery sought—
(i) Is necessary for the expeditious, fair, and reasonable consideration of the issues;
(ii) Is not unduly costly or burdensome;
(iii) Will not unduly delay the proceeding; and
(iv) Does not seek privileged information.
(4) The burden of showing that discovery should be allowed is on the party seeking discovery.
(5) The ALJ may grant discovery subject to a protective order under § 13.24.
(e)
(2) The party seeking to depose shall serve the subpoena in the manner prescribed in § 13.8.
(3) The deponent may file with the ALJ a motion to quash the subpoena or a motion for a protective order within ten days of service.
(4) The party seeking to depose shall provide for the taking of a verbatim transcript of the deposition, which it shall make available to all other parties for inspection and copying.
(f) Each party shall bear its own costs of discovery.
(a) At least 15 days before the hearing or at such other times as may be ordered by the ALJ, the parties shall exchange witness lists, copies of prior statements of proposed witnesses, and copies of proposed hearing exhibits, including copies of any written statements that the party intends to offer in lieu of live testimony in accordance with § 13.33(b). At the time the above documents are exchanged, any party that intends to rely on the transcript of deposition testimony in lieu of live testimony at the hearing, if permitted by the ALJ, shall provide each party with a copy of the specific pages of the transcript it intends to introduce into evidence.
(b) If a party objects, the ALJ shall not admit into evidence the testimony of any witness whose name does not appear on the witness list or any exhibit not provided to the opposing party as provided above unless the ALJ finds good cause for the failure or that there in no prejudice to the objecting party.
(c) Unless another party objects within the time set by the ALJ, documents exchanged in accordance with paragraph (a) of this section shall be deemed to be authentic for the purpose of admissibility at the hearing.
(a) A party wishing to procure the appearance and testimony of any individual at the hearing may request that the ALJ issue a subpoena.
(b) A subpoena requiring the attendance and testimony of an individual
(c) A party seeking a subpoena shall file a written request therefor not less than 15 days before the date fixed for the hearing unless otherwise allowed by the ALJ for good cause shown. Such request shall specify any documents to be produced and shall designate the witnesses and describe the address and location thereof with sufficient particularity to permit such witnesses to be found.
(d) The subpoena shall specify the time and place at which the witness is to appear and any documents the witness is to produce.
(e) The party seeking the subpoena shall serve it in the manner prescribed in § 13.8. A subpoena on a party or upon an individual under the control of a party may be served by first class mail.
(f) A party or the individual to whom the subpoena is directed may file with the ALJ a motion to quash the subpoena within ten days after service or on or before the time specified in the subpoena for compliance if it is less than ten days after service.
(a) A party or a prospective witness or deponent may file a motion for a protective order with respect to discovery sought by an opposing party or with respect to the hearing, seeking to limit the availability or disclosure of evidence.
(b) In issuing a protective order, the ALJ may make any order which justice requires to protect a party or person from annoyance, embarrassment, oppression, or undue burden or expense, including one or more of the following:
(1) That the discovery not be had;
(2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place;
(3) That the discovery may be had only through a method of discovery other than that requested;
(4) That certain matters not be inquired into, or that the scope of discovery be limited to certain matters;
(5) That discovery be conducted with no one present except persons designated by the ALJ;
(6) That the contents of discovery or evidence by sealed;
(7) That a deposition after being sealed be opened only by order of the ALJ;
(8) That a trade secret or other confidential research, development, commercial information, or facts pertaining to any criminal investigation, proceeding, or other administrative investigation not be disclosed or be disclosed only in a designated way; or
(9) That the parties simultaneously file specified documents or information enclosed in sealed envelopes to be opened as directed by the ALJ.
The party requesting a subpoena shall pay the cost of the fees and mileage of any witness subpoenaed in the amounts that would be payable to a witness in a proceeding in United States District Court. A check for witness fees and mileage shall accompany the subpoena when served, except that when a subpoena is issued on behalf of the authority, a check for witness fees and mileage need not accompany the subpoena.
(a)
(2) Every pleading and paper filed in the proceeding shall contain a caption setting forth the title of the action, the case number assigned by the ALJ, and a designation of the paper (
(3) Every pleading and paper shall be signed by, and shall contain the address and telephone number of the party or the person on whose behalf the paper was filed, or his or her representative.
(4) Papers are considered filed when they are mailed. Date of mailing may be established by a certificate from the party or its representative or by proof that the document was sent by certified or registered mail.
(b)
(c)
(a) In computing any period of time under this part or in an order issued thereunder, the time begins with the day following the act, event, or default, and includes the last day of the period, unless it is a Saturday, Sunday, or legal holiday observed by the Federal government, in which event it includes the next business day.
(b) When the period of time allowed is less than seven days, intermediate Saturdays, Sundays, and legal holidays observed by the Federal government shall be excluded from the computation.
(c) Where a document has been served or issued by placing it in the mail, an additional five days will be added to the time permitted for any response.
(a) Any application to the ALJ for an order or ruling shall be by motion. Motions shall state the relief sought, the authority relied upon, and the facts alleged, and shall be filed with the ALJ and served on all other parties.
(b) Except for motions made during a prehearing conference or at the hearing, all motions shall be in writing. The ALJ may require that oral motions be reduced to writing.
(c) Within 15 days after a written motion is served, or such other time as may be fixed by the ALJ, any party may file a response to such motion.
(d) The ALJ may not grant a written motion before the time for filing responses thereto has expired, except upon consent of the parties or following a hearing on the motion, but may overrule or deny such motion without awaiting a response.
(e) The ALJ shall make a reasonable effort to dispose of all outstanding motions prior to the beginning of the hearing.
(a) The ALJ may sanction a person, including any party or representative for—
(1) Failing to comply with an order, rule, or procedure governing the proceeding;
(2) Failing to prosecute or defend an action; or
(3) Engaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.
(b) Any such sanction, including but not limited to those listed in paragraphs (c), (d), and (e) of this section, shall reasonably relate to the severity and nature of the failure or misconduct.
(c) When a party fails to comply with an order, including an order for taking a deposition, the production of evidence within the party's control, or a request for admission, the ALJ may—
(1) Draw an inference in favor of the requesting party with regard to the information sought;
(2) In the case of requests for admission, deem each matter of which an admission is requested to be admitted;
(3) Prohibit the party failing to comply with such order from introducing evidence concerning, or otherwise relying upon testimony relating to the information sought; and
(4) Strike any part of the pleadings or other submissions of the party failing to comply with such request.
(d) If a party fails to prosecute or defend an action under this part commenced by service of a notice of hearing, the ALJ may dismiss the action or may issue an initial decision imposing penalties and assessments.
(e) The ALJ may refuse to consider any motion, request, response, brief or other document which is not filed in a timely fashion.
(a) The ALJ shall conduct a hearing on the record in order to determine
(b) The authority shall prove defendant's liability and any aggravating factors by a preponderance of the evidence.
(c) The defendant shall prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.
(d) The hearing shall be open to the public unless otherwise ordered by the ALJ for good cause shown.
(a) In determining an appropriate amount of civil penalties and assessments, the ALJ and the authority head, upon appeal, should evaluate any circumstances that mitigate or aggravate the violation and should articulate in their opinions the reasons that support the penalties and assessments they impose. Because of the intangible costs of fraud, the expense of investigating such conduct, and the need to deter others who might be similarly tempted, ordinarily double damages and a significant civil penalty should be imposed.
(b) Although not exhaustive, the following factors are among those that may influence the ALJ and the authority head in determining the amount of penalties and assessments to impose with respect to the misconduct (
(1) The number of false, fictitious, or fraudulent claims or statements;
(2) The time period over which such claims or statements were made;
(3) The degree of the defendant's culpability with respect to the misconduct;
(4) The amount of money or the value of the property, services, or benefit falsely claimed;
(5) The value of the Government's actual loss as a result of the misconduct, including foreseeable consequential damages and the costs of investigation;
(6) The relationship of the amount imposed as civil penalties to the amount of the Government's loss;
(7) The potential or actual impact of the misconduct upon national defense, public health or safety, or public confidence in the management of Government programs and operations, including particularly the impact on the intended beneficiaries of such programs;
(8) Whether the defendant has engaged in a pattern of the same or similar misconduct;
(9) Whether the defendant attempted to conceal the misconduct;
(10) The degree to which the defendant has involved others in the misconduct or in concealing it;
(11) Where the misconduct of employees or agents is imputed to the defendant, the extent to which the defendant's practices fostered or attempted to preclude such misconduct;
(12) Whether the defendant cooperated in or obstructed an investigation of the misconduct;
(13) Whether the defendant assisted in identifying and prosecuting other wrongdoers;
(14) The complexity of the program or transaction, and the degree of the defendant's sophistication with respect to it, including the extent of the defendant's prior participation in the program or in similar transactions;
(15) Whether the defendant has been found, in any criminal, civil, or administrative proceeding to have engaged in similar misconduct or to have dealt dishonestly with the Government of the United States or of a State, directly or indirectly; and
(16) The need to deter the defendant and others from engaging in the same or similar misconduct.
(c) Nothing in this section shall be construed to limit the ALJ or the authority head from considering any other factors that in any given case may mitigate or aggravate the offense for which penalties and assessments are imposed.
(a) The hearing may be held—
(1) In any judicial district of the United States in which the defendant resides or transacts business;
(2) In any judicial district of the United States in which the claim or statement in issue was made; or
(3) In such other place as may be agreed upon by the defendant and the ALJ.
(b) Each party shall have the opportunity to present argument with respect to the location of the hearing.
(c) The hearing shall be held at the place and at the time ordered by the ALJ.
(a) Except as provided in paragraph (b) of this section, testimony at the hearing shall be given orally by witnesses under oath or affirmation.
(b) At the discretion of the ALJ, testimony may be admitted in the form of a written statement or deposition. Any such written statement must be provided to all other parties along with the last known address of such witness, in a manner which allows sufficient time for other parties to subpoena such witness for cross-examination at the hearing. Prior written statements of witnesses proposed to testify at the hearing and deposition transcripts shall be exchanged as provided in § 13.22(a).
(c) The ALJ shall exercise reasonable control over the mode and order of interrogating witnesses and presenting evidence so as to—
(1) Make the interrogation and presentation effective for the ascertainment of the truth;
(2) Avoid needless consumption of time; and
(3) Protect witnesses from harassment or undue embarrassment.
(d) The ALJ shall permit the parties to conduct such cross-examination as may be required for a full and true disclosure of the facts.
(e) At the discretion of the ALJ, a witness may be cross-examined on matters relevant to the proceeding without regard to the scope of his or her direct examination. To the extent permitted by the ALJ, cross-examination on matters outside the scope of direct examination shall be conducted in the manner of direct examination and may proceed by leading questions only if the witness is a hostile witness, an adverse party, or a witness identified with an adverse party.
(f) Upon motion of any party, the ALJ shall order witnesses excluded so that they cannot hear the testimony of other witnesses. This rule does not authorize exclusion of—
(1) A party who is an individual;
(2) In the case of a party that is not an individual, an officer or employee of the party appearing for the entity pro se or designated by the party's representative; or
(3) An individual whose presence is shown by a party to be essential to the presentation of its case, including an individual employed by the Government engaged in assisting the representative for the Government.
(a) The ALJ shall determine the admissibility of evidence.
(b) Except as provided in this part, the ALJ shall not be bound by the Federal Rules of Evidence. However, the ALJ may apply the Federal Rules of Evidence where appropriate,
(c) The ALJ shall exclude irrelevant and immaterial evidence.
(d) Although relevant, evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or by considerations of undue delay or needless presentation of cumulative evidence.
(e) Although relevant, evidence may be excluded if it is privileged under Federal law.
(f) Evidence concerning offers of compromise or settlement shall be inadmissible to the extent provided in Rule 408 of the Federal Rules of Evidence.
(g) The ALJ shall permit the parties to introduce rebuttal witnesses and evidence.
(h) All documents and other evidence offered or taken for the record shall be open to examination by all parties, unless otherwise ordered by the ALJ pursuant to § 13.24.
(a) The hearing will be recorded and transcribed. Transcripts may be obtained following the hearing from the
(b) The transcript of testimony, exhibits and other evidence admitted at the hearing, and all papers and requests filed in the proceeding constitute the record for the decision by the ALJ and the authority head.
(c) The record may be inspected and copied (upon payment of a reasonable fee) by anyone, unless otherwise ordered by the ALJ pursuant to § 13.24.
The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief. The ALJ shall fix the time for filing such briefs, not to exceed 60 days from the date the parties receive the transcript of the hearing or, if applicable, the stipulated record. Such briefs may be accompanied by proposed findings of fact and conclusions of law. The ALJ may permit the parties to file reply briefs.
(a) The ALJ shall issue an initial decision based only on the record, which shall contain findings of fact, conclusions of law, and the amount of any penalties and assessments imposed.
(b) The findings of fact shall include a finding on each of the following issues:
(1) Whether the claims or statements identified in the complaint, or any portions thereof, violate § 13.3; and
(2) If the person is liable for penalties or assessments, the appropriate amount of any such penalties or assessments considering any mitigating or aggravating factors that he or she finds in the case, such as those described in § 13.31.
(c) The ALJ shall promptly serve the initial decision on all parties within 90 days after the time for submission of post-hearing briefs and reply briefs (if permitted) has expired. The ALJ shall at the same time serve all parties with a statement describing the right of any defendant determined to be liable for a civil penalty or assessment to file a motion for reconsideration with the ALJ or a notice of appeal with the authority head. If the ALJ fails to meet the deadline contained in this paragraph, he or she shall notify the parties of the reason for the delay and shall set a new deadline.
(d) Unless the initial decision of the ALJ is timely appealed to the authority head, or a motion for reconsideration of the initial decision is timely filed, the initial decision shall constitute the final decision of the authority head and shall be final and binding on the parties 30 days after it is issued by the ALJ.
(a) Except as provided in paragraph (d) of this section, any party may file a motion for reconsideration of the initial decision within 20 days of receipt of the initial decision. If service was made by mail, receipt will be presumed to be five days from the date of mailing in the absence of contrary proof.
(b) Every such motion must set forth the matters claimed to have been erroneously decided and the nature of the alleged errors. Such motion shall be accompanied by a supporting brief.
(c) Responses to such motions shall be allowed only upon request of the ALJ.
(d) No party may file a motion for reconsideration of an initial decision that has been revised in response to a previous motion for reconsideration.
(e) The ALJ may dispose of a motion for reconsideration by denying it or by issuing a revised initial decision.
(f) If the ALJ denies a motion for reconsideration, the initial decision shall constitute the final decision of the authority head and shall be final and binding on the parties 30 days after the ALJ denies the motion, unless the initial decision is timely appealed to the authority head in accordance with § 13.39.
(g) If the ALJ issues a revised initial decision, that decision shall constitute the final decision of the authority head and shall be final and binding on the parties 30 days after it is issued, unless it is timely appealed to the authority head in accordance with § 13.39.
(a) Any defendant who has filed a timely answer and who is determined in an initial decision to be liable for a
(b)(1) A notice of appeal may be filed at any time within 30 days after the ALJ issues an initial decision. However, if another party files a motion for reconsideration under § 13.38, consideration of the appeal shall be stayed automatically pending resolution of the motion for reconsideration.
(2) If a motion for reconsideration is timely filed, a notice of appeal may be filed within 30 days after the ALJ denies the motion or issues a revised initial decision, whichever applies.
(3) The authority head may extend the initial 30 day period for an additional 30 days if the defendant files with the authority head a request for an extension within the initial 30 day period and shows good cause.
(c) If the defendant files a timely notice of appeal with the authority head and the time for filing motions for reconsideration under § 13.38 has expired, the ALJ shall forward the record of the proceeding to the authority head.
(d) A notice of appeal shall be accompanied by a written brief specifying exceptions to the initial decision and reasons supporting the exceptions.
(e) The representative for the Government may file a brief in opposition to exceptions within 30 days of receiving the notice of appeal and accompanying brief.
(f) There is no right to appear personally before the authority head.
(g) There is no right to appeal any interlocutory ruling by the ALJ.
(h) In reviewing the initial decision, the authority head shall not consider any objection that was not raised before the ALJ unless a demonstration is made of extraordinary circumstances causing the failure to raise the objection.
(i) If any party demonstrates to the satisfaction of the authority head that additional evidence not presented at each hearing is material and that there were reasonable grounds for the failure to present such evidence at such hearing, the authority head shall remand the matter to the ALJ for consideration of such additional evidence.
(j) The authority head may affirm, reduce, reverse, compromise, remand, or settle any penalty or assessment, determined by the ALJ in any initial decision.
(k) The authority head shall promptly serve each party to the appeal with a copy of the decision of the authority head and a statement describing the right of any person determined to be liable for a penalty or assessment to seek judicial review.
(l) Unless a petition for review is filed as provided in 31 U.S.C. 3805 after a defendant has exhausted all administrative remedies under this part and within 60 days after the date on which the authority head serves the defendant with a copy of the authority head's decision, a determination that a defendant is liable under § 13.3 is final and is not subject to judicial review.
If at any time the Attorney General or an Assistant Attorney General designated by the Attorney General transmits to the authority head a written finding that continuation of the administrative process described in this part with respect to a claim or statement may adversely affect any pending or potential criminal or civil action related to such claim or statement, the authority head shall stay the process immediately. The authority head may order the process resumed only upon receipt of the written authorization of the Attorney General.
(a) An initial decision is stayed automatically pending disposition of a motion for reconsideration or of an appeal to the authority head.
(b) No administrative stay is available following a final decision of the authority head.
Section 3805 of title 31, United States Code, authorizes judicial review by an appropriate United States District Court of a final decision of the authority head imposing penalties or assessments under this part and specifies the procedures for such review.
Sections 3806 and 3808(b) of title 31, United States Code, authorize actions for collection of civil penalties and assessments imposed under this part and specify the procedures for such actions.
The amount of any penalty or assessment which has become final, or for which a judgment has been entered under § 13.42 or § 13.43, or any amount agreed upon in a compromise or settlement under § 13.46, may be collected by administrative offset under 31 U.S.C. 3716, except that an administrative offset may not be made under this subsection against a refund of an overpayment of Federal taxes, then or later owing by the United States to the defendant.
All amounts collected pursuant to this part shall be deposited as miscellaneous receipts in the Treasury of the United States, except as provided in 31 U.S.C. 3806(g).
(a) Parties may make offers of compromise or settlement at any time.
(b) The reviewing official has the exclusive authority to compromise or settle a case under this part at any time after the date on which the reviewing official is permitted to issue a complaint and before the date on which the ALJ issues an initial decision.
(c) The authority head has exclusive authority to compromise or settle a case under this part at any time after the date on which the ALJ issues an initial decision, except during the pendency of any review under § 13.42 or during the pendancy of any action to collect penalties and assessments under § 13.43.
(d) The Attorney General has exclusive authority to compromise or settle a case under this part during the pendancy of any review under § 13.42 or of any action to recover penalties and assessments under 31 U.S.C. 3806.
(e) The investigating officer may recommend settlement terms to the reviewing official, the authority head, or the Attorney General, as appropriate. The reviewing official may recommend settlement terms to the authority head, or the Attorney General, as appropriate.
(f) Any compromise or settlement must be in writing.
(a) The notice of hearing with respect to a claim or statement must be served in the manner specified in § 13.8 within 6 years after the date on which such claim or statement is made.
(b) If the defendant fails to serve a timely answer, service of a notice under § 13.10(b) shall be deemed a notice of hearing for purposes of this section.
(c) The statute of limitations may be extended by agreement of the parties.
Sec. 1, 80 Stat. 306 (28 U.S.C. 2672); sec. 2679, 62 Stat. 984 as amended (28 U.S.C. 2679); sec. 161, 68 Stat. 948 as amended (42 U.S.C. 2201); 28 CFR 14.11.
(a) The terms “Nuclear Regulatory Commission” and “NRC” as used in this part mean the agency established by section 201(a) of the Energy Reorganization Act of 1974, but do not include any contractor with the Nuclear Regulatory Commission.
(b) The regulations in this part supplement the Department of Justice's regulations in 28 CFR parts 14 and 15.
(c) These regulations apply to administrative claims under the Federal Tort Claims Act, as amended, asserted on or after the effective date of this rule, for money damages against the United States for damage to or loss of property or personal injury or death caused by the negligent or wrongful act or omission of any employee of the NRC while acting within the scope of his or her office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred.
(d) These regulations also set forth the procedures when lawsuits are commenced against an employee of the NRC resulting from the operation of a motor vehicle while acting within the scope of his or her employment.
(a) An attorney may not charge or receive fees in excess of:
(1) 25 percent of any judgment rendered under 28 U.S.C. 1346(b);
(2) 25 percent of any settlement made under 28 U.S.C. 2677; or
(3) 20 percent of any award, compromise, or settlement made under 28 U.S.C. 2672.
(b) Any attorney who charges or receives any amount in excess of that allowed under this section is subject to a fine of not more than $2,000 or imprisonment for not more than one year, or both. (28 U.S.C. 2678)
(a) A claim for damage to or loss of property may be presented by the owner of the property interest which is the subject of the claim, his or her duly authorized agent, or his or her legal representative.
(b) A claim for personal injury may be presented by the injured person, his or her duly authorized agent, or his or her legal representative.
(c) A claim based on death may be presented by the executor or administrator of the decedent's estate, or by any other person legally entitled to assert the claim under applicable State law.
(d) A claim for loss wholly compensated by an insurer with the rights of a subrogee may be presented by the insurer. A claim for loss partially compensated by an insurer with the rights of a subrogee may be presented by the insurer or the insured individually, to the extent of their respective interests, or jointly. Whenever an insurer presents a claim asserting the rights of a subrogee, the insurer shall present with the claim appropriate evidence that the insurer has the rights of a subrogee.
(e) If a claim is presented by an agent or legal representative that person shall:
(1) Present the claim in the name of the claimant;
(2) Sign the claim;
(3) Show the title or legal capacity of the person signing the claim; and
(4) Include with the claim evidence of his or her authority to present a claim on behalf of the claimant as agent, executor, administrator, parent, guardian, or other representative.
For purposes of the provisions of 28 U.S.C. 2672, a claim is presented when NRC receives from a claimant, or the claimant's duly authorized agent or legal representative, an executed
A claimant shall mail or deliver the claim to the office of employment of the NRC employee whose negligent or wrongful act or omission is alleged to have caused the loss or injury. If the office of employment is not known, the claimant shall file the claim with the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
A claimant shall present the claim to the Federal agency whose activities gave rise to the claim. If a claim is erroneously presented to the NRC, the NRC shall transfer it to the appropriate agency, if the proper agency can be identified from the claim, and shall advise the claimant of the transfer. If transfer is not feasible, the NRC shall return the claim to the claimant. The fact of transfer does not, in itself, preclude further transfer, return of the claim to the claimant, or other appropriate disposition of the claim. A claim shall be presented, as required by 28 U.S.C. 2401(b), as of the date it is received by the appropriate agency.
(a) If the NRC and one or more other Federal agencies is or may be involved in the events giving rise to the claim, and if the claim is filed with the NRC, the NRC shall contact all other affected agencies in order to designate the single agency which will investigate and decide the merits of the claim.
(1) In the event that an agreed upon designation cannot be made by the affected agencies, the Department of Justice will be consulted and will designate a primary agency to investigate and decide the merits of the claim. If the NRC is designated as the primary agency, it shall notify the claimant that all future correspondence concerning the claim shall be directed to the NRC.
(2) All involved Federal agencies can agree either to conduct their own administrative reviews and to coordinate the results or to have the investigations conducted by the primary agency. In either event, the primary agency is responsible for the final determination of the claim.
(b) A claimant presenting a claim arising from an incident to more than one agency should identify each agency to which the claim is submitted at the time each claim is presented. If a claim arising from an incident is presented to more than one Federal agency without any indication that more than one agency is involved, and any one of the concerned Federal agencies takes final action on that claim, the final action is conclusive on the claims presented to the other agencies in regard to the time required for filing suit set forth in 28 U.S.C. 2401(b). However, if NRC, as a subsequently involved Federal agency, desires to take further action with a view towards settling the claim, the NRC may treat the matter as a request for reconsideration of the final denial under 10 CFR 14.39, unless suit has been filed in the interim, and advise the claimant of the action.
If, after a final denial by another agency, the claimant files with the NRC a claim arising out of the same incident on which the claim filed with the other agency was based, the submission of the claim to NRC will not toll the requirement of 28 U.S.C. 2401(b) that suit must be filed within six months of the final denial by the other agency, unless the other agency specifically and explicitly treats the submission to NRC as a request for reconsideration under 10 CFR 14.39 and advises the claimant of the action.
(a)
(1) An authenticated death certificate or other competent evidence showing cause of death, date of death, and age of decedent.
(2) Decedent's employment or occupation at time of death, including his or her monthly or yearly salary or earnings (if any), and the duration of his or her last employment or occupation.
(3) Full names, addresses, birth dates, kinship, and marital status of the decedent's survivors, including identification of those survivors who were dependent for support upon the decedent at the time of death.
(4) Degree of support afforded by the decedent to each survivor dependent upon him or her for support at the time of death.
(5) Decedent's general physical and mental condition before death.
(6) Itemized bills for medical and burial expenses incurred by reason of the incident causing death, or itemized receipts of payment for these expenses.
(7) If damages for pain and suffering prior to death are claimed, a physician's detailed statement specifying the injuries suffered, duration of pain and suffering, any drugs administered for pain, and the decedent's physical condition in the interval between injury and death.
(8) Any other evidence or information which may have a bearing on either the responsibility of the United States for the death or the amount of damages claimed.
(b)
(1) A written report by the attending physician or dentist setting forth the nature and extent of the injury, nature and extent of treatment, any degree of temporary or permanent disability and prognosis, period of hospitalization, and any diminished earning capacity. In addition, the claimant may be required to submit to a physical or mental examination by a physician employed by the NRC or another Federal agency. The claimant may request in writing a copy of the report of the examining physician if the claimant has:
(i) Furnished the report referred to in paragraph (a)(1) of this section on request; and
(ii) Made or agrees to make available to the NRC all other reports of the claimant's physical or mental condition which have been or are made by any physician.
(2) Itemized bills for medical, dental, and hospital expenses incurred, or itemized receipts of payment for these expenses.
(3) If the prognosis reveals the necessity for future treatment, a statement of expected expenses for the treatment.
(4) If a claim is made for loss of time from employment, a written statement from his or her employer showing actual time lost from employment, whether he or she is a full- or part-time employee, and wages or salary actually lost.
(5) If a claim is made for loss of income and the claimant is self-employed, documentary evidence showing the amount of earnings actually lost.
(6) Any other evidence or information which may have a bearing on either the responsibility of the United States for the personal injury or the damages claimed.
(c)
(1) Proof of ownership of the property interest which is the subject of the claim.
(2) A detailed statement of the amount claimed with respect to each item of property.
(3) An itemized receipt of payment for necessary repairs or itemized written estimates of the cost of these repairs.
(4) A statement listing date of purchase, purchase price, and salvage value, where repair is not economical.
(5) Any other evidence or information which may have a bearing on either the responsibility of the United States for the injury to or loss of property or the damages claimed.
The claimant may amend a claim presented in compliance with 10 CFR 14.13 at any time prior to final agency action or prior to the exercise of the claimant's option under 28 U.S.C. 2675(a). The claimant or his or her duly authorized agent or legal representative shall sign each amendment and submit it in writing. Upon the timely filing of an amendment to a pending claim, the agency shall have six months in which to make a final disposition of the claim as amended and the claimant's option under 28 U.S.C. 2675(a) does not accrue until six months after the filing of an amendment.
The claimant shall furnish evidence and information of the types described in 10 CFR 14.23, to the extent reasonably practicable, when the claim is initially presented. If the claimant fails to furnish sufficient evidence and information within six months after the claim was initially presented to enable NRC to adjust, determine, compromise and settle the claim, NRC may consider the claim a nullity.
The NRC may:
(a) Require the claimant to furnish any evidence or information which is relevant to its consideration of the claim;
(b) Examine the claimant; or
(c) Investigate, or request any other Federal agency to investigate, a claim filed under this part.
The General Counsel or the General Counsel's designee shall exercise the authority to adjust, determine, compromise and settle a claim under the provisions of 28 U.S.C. 2672.
(a) The NRC shall effect an award, compromise, or settlement of a claim hereunder in excess of $25,000 only with the prior written approval of the Attorney General or his designee. For the purposes of this paragraph, a principal claim and any derivative or subrogated claim are treated as a single claim.
(b) The NRC may adjust, determine, compromise, or settle a claim under this part only after consultation with the Department of Justice if, in the opinion of the Office of the General Counsel:
(1) A new precedent or a new point of law is involved;
(2) A question of policy is or may be involved;
(3) The United States is or may be entitled to indemnity or contribution from a third party and the NRC is unable to adjust the third party claim; or
(4) The compromise of a particular claim, as a practical matter, will or may control the disposition of a related claim in which the amount to be paid may exceed $25,000.
(c) The NRC may adjust, determine, compromise, or settle a claim under this part only after consultation with the Department of Justice if the NRC is informed or is otherwise aware that the United States, or an employee, agent, or cost-plus contractor of the United States, is involved in litigation based on a claim arising out of the same incident or transaction.
(d) When Department of Justice approval or consultation is required under this section or the advice of the Department of Justice is otherwise requested, the NRC shall direct the referral or request to the Assistant Attorney General, Civil Division, Department of Justice, in writing. The NRC shall ensure that the referral or request contains:
(1) A short and concise statement of the facts and the reasons for the referral or request;
(2) Copies of relevant portions of NRC's claim file; and
(3) A statement of the recommendations or views of the NRC.
The NRC shall send notice of a final denial of a claim in writing to the claimant, his or her attorney or legal representative, by certified or registered mail. The notification of final denial may include a statement of the reasons for the denial. The NRC shall include a statement in the notification of final denial that, if the claimant is dissatisfied with NRC's action, he or she may file suit in an appropriate U.S. District Court not later than 6 months after the date of mailing of the notification.
Prior to the commencement of suit and prior to the expiration of the 6-month period provided in 28 U.S.C. 2401(b), a claimant, or his or her duly authorized agent, or legal representative, may file a written request with the NRC for reconsideration of a final denial of a claim. Upon the timely filing of a request for reconsideration, the NRC shall have 6 months from the date of filing in which to make a final disposition of the claim, and the claimant's option under 28 U.S.C. 2675(a) does not accrue until 6 months after the filing of a request for reconsideration. Final NRC action on a request for reconsideration shall be effected in accordance with the provisions of 10 CFR 14.37.
(a) The NRC shall pay any award, compromise, or settlement in an amount of $2,500 or less made under the provisions of 28 U.S.C. 2672 out of the appropriations available to it. The NRC shall obtain payment of any award, compromise, or settlement in excess of $2,500 from the Department of the Treasury by forwarding Standard Form 1145 to the Payment Branch, Claims Group, General Accounting Office. If an award, compromise, or settlement is in excess of $25,000, Standard Form 1145 must be accompanied by evidence that the award, compromise, or settlement has been approved by the Attorney General or the Attorney General's designee. When the use of Standard Form 1145 is required, it must be executed by the claimant or it must be accompanied by either a claims settlement agreement or a Standard Form 95 executed by the claimant.
(b) If a claimant is represented by an attorney, the voucher for payment must designate both the claimant and his or her attorney as payees, and the check must be delivered to the attorney whose address appears on the voucher.
Acceptance by the claimant, his agent, or legal representative, of any award, compromise, or settlement made under the provisions of 28 U.S.C. 2672 or 2677, is final and conclusive on the claimant, his or her agent or legal representative and any other person on whose behalf or for whose benefit the claim has been presented. Acceptance constitutes a complete release of any claim against the United States and against any employee of the Government whose act or omission gave rise to the claim.
(a) Any NRC employee against whom a civil action or proceeding is brought for damage to property, or for personal injury or death, on account of the employee's operation of a motor vehicle in the scope of his or her office or employment with the NRC, shall promptly deliver all process and pleadings served upon the employee, or an attested true copy, to the Office of the General Counsel. If the action is brought against an employee's estate, this procedure applies to the employee's personal representative.
(b) In addition, upon the employee's receipt of any process or pleadings, or any prior information regarding the commencement of a civil action or proceeding, the employee shall immediately advise the Office of the General Counsel by telephone or telegraph.
A report containing all data bearing upon the question whether the employee was acting within the scope of
Upon a certification by the United States Attorney that the defendant employee was acting within the scope of his or her office or employment at the time of the incident out of which the suit arose, any civil action or proceeding commenced in a State court may be removed to the district court of the United States for the district and division encompassing the place where the action or proceeding is pending in accordance with 28 U.S.C. 2679.
The remedy against the United States provided by 28 U.S.C. 1346(b) and 2672 for damage to or loss of property or personal injury or death, resulting from the operation by an employee of the Government of any motor vehicle while acting within the scope of his or her office or employment, is exclusive of any other civil action or proceeding by reason of the same subject matter against the employee or his or her estate whose act or omission gave rise to the claim.
Secs. 161, 186, 68 Stat. 948, 955, as amended (42 U.S.C. 2201, 2236); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1, Pub. L. 97-258, 96 Stat. 972 (31 U.S.C. 3713); sec. 5, Pub. L. 89-508, 80 Stat. 308, as amended (31 U.S.C. 3716); Pub. L. 97-365, 96 Stat. 1749 (31 U.S.C. 3719); Federal Claims Collection Standards, 31 CFR Chapter IX, parts 900-904; 31 U.S.C. Secs. 3701, 3716; 31 CFR Sec. 285; 26 U.S.C. Sec. 6402(d); 31 U.S.C. Sec. 3720A; 26 U.S.C. Sec. 6402(c); 42 U.S.C. Sec. 664; Pub. L. 104-134, as amended (31 U.S.C. 3713); 5 U.S.C. 5514; Executive Order 12146 (3 CFR, 1980 Comp. pp. 409-412); Executive Order 12988 (3 CFR, 1996 Comp., pp. 157-163).
(a) This part applies to claims for the payment of debts owed to the United States Government in the form of money or property and; unless a different procedure is specified in a statute, regulation, or contract; prescribes procedures by which the NRC—
(1) Collects, compromises, suspends, offsets, and terminates collection action for claims;
(2) Determines and collects interest and other charges on these claims; and
(3) Refers unpaid claims over 180 days delinquent to Treasury for offset and collection and to the DOJ for litigation.
(b) The following are examples of kinds of debts to which special statutory and administrative procedures apply:
(1) A claim against an employee for erroneous payment of pay and allowances subject to waiver under 5 U.S.C. 5584 are covered by the provisions of 10 CFR part 16.
(2) A claim against an applicant for, or a holder or former holder of, an NRC license involving the payment of civil penalties imposed by the NRC under 10 CFR 2.205.
(3) A claim involved in a case pending before any Federal Contract Appeals Board or Grant Appeals Board. However, nothing in this part prevents negotiation and settlement of a claim pending before a Board.
(c) The NRC is not limited to collection remedies contained in the revised Federal Claims Collection Standards (FCCS). The FCCS is not intended to impair common law remedies.
Unless otherwise specified, all communications concerning the regulations in this part should be addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff. Communications may be delivered in person to the Commission's offices located at 11555 Rockville Pike, One White Flint North, Rockville, Maryland 20852-2738.
(a) These procedures generally apply to any claim for payment of a debt which:
(1) Results from activities of the NRC, including fees imposed under part 170 and part 171; or
(2) Is referred to the NRC for collection.
(b) These procedures do not apply to:
(1) A claim based on a civil monetary penalty for violation of a licensing requirement unless § 2.205 of this chapter provides otherwise;
(2) A claim as to which there is an indication of fraud, the presentation of a false claim, or misrepresentation on the part of the debtor or any other party having an interest in the claim;
(3) A claim based in whole or in part on conduct in violation of the antitrust laws;
(4) A claim under the Internal Revenue Code of 1986.
(5) A claim between Federal agencies. Federal agencies should attempt to resolve interagency claims as referenced in Executive Order 12146 (3 CFR, 1980 Comp., pp. 409-412).
(6) A claim once it becomes subject to salary offset under 5 U.S.C. 5514. These claims are subject to the provisions of 10 CFR part 16.
(7) A claim involving bankruptcy is covered by Title 11 of the United States Code.
The NRC's authority to compromise a claim, or to terminate or suspend collection action on a claim covered by these procedures, is limited by 31 U.S.C. 3711(a) to claims that—
(a) Have not been referred to another Federal Agency for further collection actions; and
(b) Do not exceed $100,000 (exclusive of interest, penalties, and administrative charges) or such higher amount as the Attorney General shall from time to time prescribe for purposes of compromise or suspension or termination of collection activity.
This part contains no information collection requirements, and therefore, is not subject to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501
(a) The failure of NRC to include in this part any provision of the FCCS, 31 CFR Chapter IX, parts 900-904, does not prevent the NRC from applying these provisions.
(b) A debtor may not use the failure of the NRC to comply with any provision of this part or of the Federal
These procedures are directed primarily to the recovery of money on behalf of the Government. The NRC may demand:
(a) The return of specific property; or
(b) The performance of specific services.
The NRC shall consider a debtor's liability arising from a particular transaction or contract as a single claim in determining whether the claim is less than the monetary limitation for the purpose of compromising or suspending or terminating collection action. A claim may not be subdivided to avoid the monetary limitation established by 31 U.S.C. 3711(a)(2) and § 15.7.
(a) The NRC shall take aggressive action to collect all debts. These collection activities will be undertaken promptly and follow-up action will be taken as appropriate. These regulations do not require the Department of Justice, Department of the Treasury (Treasury), or any other Treasury-designated collection center to duplicate collection activities previously undertaken by NRC.
(b) Debt referred or transferred to Treasury or to a Treasury-designated debt collection center under the authority of 31 U.S.C. 3711(g) must be serviced, collected, or compromised, or the collection action will be suspended or terminated, in accordance with the statutory requirements and authorities applicable to the collection of the debts.
(c) The NRC shall cooperate with other agencies in their debt collection activities.
(d) The NRC will consider referring debts that are less than 180 days delinquent to Treasury or to a Treasury-designated debt collection center to accomplish efficient, cost-effective debt collection. Referrals to debt collection centers are at the discretion of, and for a time period acceptable to, Treasury.
(e) The NRC shall transfer any debt that has been delinquent for 180 days or more to Treasury so that it may take appropriate action to collect the debt or terminate collection actions. This requirement does not apply to any debt that—
(1) Is in litigation or foreclosure;
(2) Will be disposed of under an approved asset sale program;
(3) Has been referred to a private collection contractor for a period of time acceptable to Treasury;
(4) Is at a debt collection center for a period of time acceptable to Treasury;
(5) Will be collected under internal offset procedures within 3 years after the date the debt first became delinquent; or
(6) Is exempt from this requirement based on a determination by Treasury that exemption for a certain class of debt is in the best interest of the United States.
(f) Agencies operating Treasury-designated debt collection centers are authorized to charge a fee for services rendered regarding referred or transferred debts. The fee may be paid out of amounts collected and may be added to the debt as an administrative cost.
(a) The NRC shall make appropriate written demands upon the debtor for payment of money or the return of specific property in terms which specify:
(1) The basis of the indebtedness and the right of the debtor to seek review within the NRC;
(2) The amount claimed;
(3) A description of any property which is to be returned by a date certain;
(4) The date on which payment is to be made (which is normally the date
(5) The applicable standards for assessing interest, penalties, and administrative costs under 31 CFR 901.9;
(6) The applicable policy for reporting the delinquent debt to consumer reporting agencies; and
(7) The name, address, and phone number of a contact person or office within the NRC will be included with each demand letter.
(b) The NRC shall normally send two demand letters to debtors. The initial demand letter will be followed approximately 30 days later with a second demand letter, unless circumstances indicate that alternative remedies better protect the Government's interest, that the debtor has explicitly refused to pay, or that sending a further demand letter is futile. Depending upon the circumstances, the first and second demand letters may—
(1) Offer or seek to confer with the debtor;
(2) State the amount of the interest and penalties that will be added on a daily basis as well as the administrative costs that will be added to the debt until the debt is paid; and
(3) State that the authorized collection procedures include any procedure authorized in this part including:
(i) Contacts with the debtor's employer when the debtor is employed by the Federal Government or is a member of the military establishment or the Coast Guard;
(ii) The NRC may report debts to credit bureaus, refer debts to debt collection centers and collection agencies for cross-servicing (including wage garnishment), tax refund offset, administrative offset, and litigation. Any eligible debt that is delinquent for 180 days or more will be transferred to the Treasury for collection. Credit bureau reporting for transferred debts will be handled by Treasury or a Treasury-designated center.
(iii) Possible reporting of the delinquent debt to consumer reporting agencies in accordance with the guidance and standards contained in 31 CFR 901.4.
(iv) The suspension or revocation of a license or other remedy under § 15.29;
(v) Installment payments possibly requiring security; and
(vi) The right to refer the claim to DOJ for litigation.
(c) The NRC shall normally send only one written demand to a debtor who is a current NRC employee. The procedure described in § 15.33 and 10 CFR part 16 will be followed if full payment is not received either 30 days from the date the initial written demand was mailed or hand delivered. If the NRC cannot obtain full payment by following the procedures described in § 15.33 and 10 CFR part 16, the NRC may follow other collection procedures described in this subpart.
(d) The failure to state in a letter of demand a matter described in § 15.21 is not a defense for a debtor and does not prevent the NRC from proceeding with respect to that matter.
(e) When the NRC learns that a bankruptcy petition has been filed with respect to a debtor, the NRC will cease collection action immediately unless it has been determined that under 11 U.S.C. 362, the automatic stay has been lifted or is no longer in effect.
(a) If a debtor has not responded to one or more demands, the NRC shall make reasonable efforts by telephone or internet to determine the debtor's intentions.
(b) The NRC may undertake an investigation to locate a debtor if the whereabouts of a debtor is a problem, or if a debtor cannot be contacted by telephone.
(c) The NRC, under 15 U.S.C. 1681(f), may obtain consumer credit information from private firms, including the name, address, former addresses, place of employment, and former places of employment of a debtor.
(a) The NRC may seek an interview with the debtor at the offices of the NRC when—
(1) A matter involved in the claim needs clarification;
(2) Information is needed concerning the debtor's circumstances; or
(3) An agreement for payment might be negotiated.
(b) The NRC shall grant an interview with a debtor upon the debtor's request. The NRC will not reimburse a debtor's interview expenses.
(a) In addition to assessing interest, penalties, and administrative costs under § 15.37, the NRC may report a debt that has been delinquent for 90 days to a consumer reporting agency if all the conditions of this paragraph are met.
(1) The debtor has not—
(i) Paid or agreed to pay the debt under a written payment plan that has been signed by the debtor and agreed to by the NRC; or
(ii) Filed for review of the debt under § 15.26 (a)(2)(iv).
(2) The NRC has included a notification in the second written demand (see § 15.21(b)) to the individual debtor stating—
(i) That the payment of the debt is delinquent;
(ii) That within not less than 60 days after the date of the notification, the NRC intends to disclose to a consumer reporting agency that the individual debtor is responsible for the debt;
(iii) The specific information to be disclosed to the consumer reporting agency; and
(iv) That the debtor has a right to a complete explanation of the debt (if that has not already been given), to dispute information in NRC records about the debt, and to request reconsideration of the debt by administrative appeal or review of the debt.
(3) The NRC has reconsidered its initial decision on the debt when the debtor has requested a review under paragraph (a)(2)(iv) of this section.
(4) The NRC has taken reasonable action to locate a debtor for whom the NRC does not have a current address to send the notification provided for in paragraph (a)(2) of this section.
(b) If there is a substantial change in the condition or amount of the debt, the NRC shall—
(1) Promptly disclose that fact(s) to each consumer reporting agency to which the original disclosure was made;
(2) Promptly verify or correct information about a debt on request of a consumer reporting agency for verification of information disclosed by the NRC; and,
(3) Obtain assurances from the consumer reporting agency that the agency is complying with all applicable Federal, state and local laws relating to its use of consumer credit information.
(c) The information the NRC discloses to the consumer reporting agency is limited to—
(1) Information necessary to establish the identity of the individual debtor, including name, address, and taxpayer identification number;
(2) The amount, status, and history of the debt; and
(3) The NRC activity under which the debt arose.
If the debtor is employed by the Federal government or is a member of the military establishment or the Coast Guard, collection by offset must be accomplished in accordance with 5 U.S.C. 5514 and the provisions of 10 CFR part 16.
In non-bankruptcy cases, the NRC may suspend or revoke any license, permit, or approval which the NRC has granted to the debtor for any inexcusable, prolonged, or repeated failure of the debtor to pay a delinquent debt. Before suspending or revoking any license, permit, or approval for failure to pay a debt, the NRC shall issue to the
(a) A debtor who disputes a debt shall explain why the debt is incorrect in fact or in law within 30 days from the date that the initial demand letter was mailed or hand-delivered. The debtor may support the explanation by affidavits, cancelled checks, or other relevant evidence.
(b) If the debtor's arguments appear to have merit, the NRC may extend the interest waiver period as described in § 15.37(j) pending a final determination of the existence or amount of the debt.
(c) The NRC may investigate the facts involved in the dispute and, if it considers it necessary, arrange for a conference at which the debtor may present evidence and any arguments in support of the debtor's position.
The NRC may contract for collection services in order to recover delinquent debts only if the debts are not subject to the DCIA requirement to transfer debts to Treasury for debt collection services, e.g. debts that are less than 180 days delinquent. However, the NRC retains the authority to resolve disputes, compromise claims, suspend or terminate collection action, and initiate enforced collection through litigation. When appropriate, the NRC shall contract for collection services in accordance with the guidance and standards contained in 31 CFR chapter IX, parts 900-904.
(a)
(2) This section does not apply to:
(i) Debts arising under the Social Security Act, except as provided in 42 U.S.C. 404;
(ii) Payments made under the Social Security Act, except as provided for in 31 U.S.C. 3716(c) (see 31 CFR 285.4, Federal Benefit Offset);
(iii) Debts arising under, or payments made under, the Internal Revenue Code (see 31 CFR 285.2, Tax Refund Offset) or the tariff laws of the United States;
(iv) Offsets against Federal salaries to the extent these standards are inconsistent with regulations published to implement such offsets under 5 U.S.C. 5514 and 31 U.S.C. 3716 (see 5 CFR part 550, subpart K, and 31 CFR 285.7, Federal Salary Offset);
(v) Offsets under 31 U.S.C. 3728 against a judgment obtained by a debtor against the United States;
(vi) Offsets or recoupments under common law, State law, or Federal statutes specifically prohibiting offsets or recoupments of particular types of debts; or
(vii) Offsets in the course of judicial proceedings, including bankruptcy.
(3) Unless otherwise provided for by contract or law, debts or payments that are not subject to administrative offset under 31 U.S.C. 3716 may be collected by administrative offset under the common law or their applicable statutory authority.
(4) Unless otherwise provided by law, the NRC may not initiate administrative offset of payments under the authority of 31 U.S.C. 3716 to collect a debt more than 10 years after the Government's right to collect the debt first accrued, unless facts material to the Government's right to collect the debt were not known and could not reasonably have been known to the NRC, or collection of “approval” fees has been deferred under 10 CFR part 170. If the collection of “approval” fees has been deferred, the ten-year period begins to run at the end of the deferral period.
(5) In bankruptcy cases, the NRC will seek legal advice from its Office of the General Counsel concerning the impact of the Bankruptcy Code on pending or contemplated collections by offset.
(b)
(2) The names and taxpayer identifying numbers (TINs) of debtors who owe debts referred to Treasury as described in paragraph (b)(1) of this section must be compared to the names and TINs on payments to be made by Federal disbursing officials. Federal disbursing officials include disbursing officials of Treasury, the Department of Defense, the United States Postal Service, other Government corporations, and disbursing officials of the United States designated by Treasury. When the name and TIN of a debtor match the name and TIN of a payee and all other requirements for offset have been met, the payment will be offset to satisfy the debt.
(3) Federal disbursing officials will notify the debtor/payee in writing that an offset has occurred to satisfy, in part or in full, a past due, legally enforceable delinquent debt. The notice must include a description of the type and amount of the payment from which the offset was taken, the amount of offset that was taken, the identity of the creditor agency (NRC) requesting the offset, and a contact point within NRC who will respond to questions regarding the offset
(c)
(i) Offsets may be initiated only after the debtor has been sent written notice of the type and amount of the debt, the intention of the NRC to use administrative offset to collect the debt, and an explanation of the debtor's rights under 31 U.S.C. 3716; and
(ii) The debtor has been given—
(A) The opportunity to inspect and copy NRC records related to the debt;
(B) The opportunity for a review within the NRC of the determination of indebtedness; and
(C) The opportunity to make a written agreement to repay the debt.
(iii) The procedures set forth in paragraph (c)(1)(i) of this section may be omitted when—
(A) The offset is in the nature of a recoupment;
(B) The debt arises under a contract as set forth in Cecile Industries, Inc. v. Cheney, 995 F.2d 1052 (Fed. Cir. 1993) (notice and other procedural protections set forth in 31 U.S.C. 3716(a) do not supplant or restrict established procedures for contractual offsets accommodated by the Contracts Disputes Act); or
(C) The NRC first learns of the existence of the amount owed by the debtor when there is insufficient time before payment would be made to the debtor/payee to allow for prior notice and an opportunity for review. This applies to non-centralized offsets conducted under paragraph (d) of this section. When prior notice and an opportunity for review are omitted, the NRC shall give the debtor notice and an opportunity for review as soon as practicable
(iv) When an agency previously has given a debtor any of the required notice and review opportunities with respect to a particular debt (31 CFR 901.2), the NRC need not duplicate the notice and review opportunities before administrative offset may be initiated.
(2) When referring delinquent debts to Treasury, the NRC shall certify, in a form acceptable to Treasury, that:
(i) The debt is past due and legally enforceable; and
(ii) The NRC has complied with all due process requirements under 31 U.S.C. 3716(a) and the NRC's regulations.
(3) Payments that are prohibited by law from being offset are exempt from centralized administrative offset. The Treasury shall exempt payments under means-tested programs from centralized administrative offset when requested in writing by the head of the payment-certifying or authorizing agency. Also, the Treasury may exempt other classes of payments from centralized offset upon the written request of the head of the payment-certifying or authorizing agency.
(4) Benefit payments made under the Social Security Act (42 U.S.C. 301
(5) In accordance with 31 U.S.C. 3716(f), the Treasury may waive the provisions of the Computer Matching and Privacy Protection Act of 1988 concerning matching agreements and post-match notification and verification (5 U.S.C. 552a(o) and (p)) for centralized administrative offset upon receipt of a certification from the NRC that the due process requirements enumerated in 31 U.S.C. 3716(a) have been met. The certification of a debt in accordance with paragraph (c)(2) of this section will satisfy this requirement. If a waiver is granted, only the Data Integrity Board of the Department of the Treasury is required to oversee any matching activities, in accordance with 31 U.S.C. 3716(g). This waiver authority does not apply to offsets conducted under paragraphs (c) and (d) of this section.
(d)
(2) Before requesting Treasury to conduct a non-centralized administrative offset, the NRC adopts the following procedures, which provide that such offsets may occur only after:
(i) The debtor has been provided due process as set forth in paragraph (c)(1) of this section; and
(ii) The Treasury has received written certification from NRC that the debtor owes the past due, legally enforceable delinquent debt in the amount stated, and that the NRC has fully complied with its regulations concerning administrative offset.
(3) Treasury shall comply with offset requests by NRC to collect debts owed to the United States, unless the offset would not be in the best interests of the United States with respect to the Treasury's program, or would otherwise be contrary to law. Appropriate use should be made of the cooperative efforts of other agencies in effecting collection by administrative offset.
(4) When collecting multiple debts by non-centralized administrative offset, the NRC will apply the recovered amounts to those debts in accordance
(e)
(f)
(2) Unless otherwise required by law, an oral hearing under this section is not required to be a formal evidentiary hearing, although the NRC should carefully document all significant matters discussed at the hearing.
(3) This section does not require an oral hearing with respect to debt collection systems in which a determination of indebtedness rarely involves issues of credibility or veracity, and the NRC has determined that review of the written record is ordinarily an adequate means to correct prior mistakes.
(4) In those cases in which an oral hearing is not required by this section, the NRC shall accord the debtor a “paper hearing,” that is, a determination of the request for reconsideration based upon a review of the written record.
(a)
(b) Payment by installment. If a debtor furnishes satisfactory evidence of inability to pay a claim in one lump sum, payment in regular installments may be arranged. Evidence may consist of a financial statement or a signed statement that the debtor's application for a loan to enable the debtor to pay the claim in full was rejected. Except for a claim described in 5 U.S.C. 5514 and codified in 10 CFR part 16, all installment payment arrangements must be in writing and require the payment of interest and administrative charges.
(1) Installment note forms may be used. The written installment agreement must contain a provision accelerating the debt payment in the event the debtor defaults. If the debtor's financial statement discloses the ownership of assets which are free and clear of liens or security interests, or assets in which the debtor owns an equity, the debtor may be asked to secure the payment of an installment note by executing a Security Agreement and Financing Statement transferring to the United States a security interest in the asset until the debt is discharged.
(2) If the debtor owes more than one debt, the NRC will apply the payment to the various debts in accordance with the best interests of the United States, as determined by the facts and circumstances of the particular case.
(c) To whom payment is made. Payment of a debt is made by check, electronic transfer, draft, credit card, or money order and should be payable to the United States Nuclear Regulatory Commission, License Fee and Accounts Receivable Branch, P.O. Box 954514, St. Louis, MO. 63195-4514, unless payment is—
(1) Made pursuant to arrangements with DOJ;
(2) Ordered by a Court of the United States; or
(3) Otherwise directed in any other part of this chapter.
(a) The NRC shall assess interest, penalties, and administrative costs on debts owed to the United States Government in accordance with the guidance provided under the FCCS, 31 CFR 901.9.
(b) Before assessing any charges on delinquent debt, the NRC shall mail or hand-deliver a written notice to the debtor explaining its requirements concerning these charges under 31 CFR 901.2 and 901.9, except where these charges are included in a contractual or repayment agreement.
(c) Interest begins to accrue from the date on which the initial written demand, advising the debtor of the interest requirements, is first mailed or hand delivered to the debtor unless a different date is specified in a statute, regulation, or contract.
(d) The NRC shall assess interest based upon the rate of the current value of funds to the United States Treasury (the Treasury tax and loan account rate) prescribed for the current quarter and published in the
(e) Interest is computed only on the principal of the debt and the interest rate remains fixed for the duration of the indebtedness, unless a debtor defaults on a repayment agreement and seeks to enter into a new agreement.
(f) The NRC shall assess against a debtor charges to cover administrative costs incurred as a result of a delinquent debt. Administrative costs may include costs incurred in obtaining a credit report or in using a private debt collector, to the extent they are attributable to the delinquency.
(g) The NRC shall assess a penalty charge of 6 percent a year on any portion of a debt that is delinquent for more than 90 days. The charge accrues retroactively to the date that the debt became delinquent.
(h) Amounts received by the NRC as partial or installment payments are applied first to outstanding penalty and administrative cost charges, second to accrued interest, and third to outstanding principal.
(i) The NRC shall waive collection of interest on the debt or any portion of the debt which is paid in full within 30 days after the date on which interest began to accrue.
(j) The NRC may waive interest during the period a debt disputed under § 15.31 is under investigation or review by the NRC. However, this additional waiver is not automatic and must be requested before the expiration of the initial 30-day waiver period. The NRC may grant the additional waiver only when it finds merit in the explanation the debtor has submitted under § 15.31.
(k) The NRC may waive the collection of interest, penalties, and administrative costs if it finds that one or more of the following conditions exist:
(1) The debtor is unable to pay any significant sum toward the debt within a reasonable period of time;
(2) Collection of interest, penalties, and administrative costs will jeopardize collection of the principal of the debt;
(3) The NRC is unable to enforce collection in full within a reasonable time by enforced collection proceedings; or
(4) Collection would be against equity and good conscience or not in the best interests of the United States, including the situation in which an administrative offset or installment payment agreement is in effect.
(l) The NRC is authorized to impose interest and related charges on debts not subject to 31 U.S.C. 3717, in accordance with common law.
The NRC may institute a credit investigation of the debtor at any time following receipt of knowledge of the
(a) The collection and compromise of a debt;
(b) The collection of interest, penalties, and administrative costs;
(c) The use of administrative offset;
(d) The use of other collection methods; and
(e) The likelihood of collecting the debt.
When the NRC learns that a bankruptcy petition has been filed with respect to a debtor, before proceeding with further collection action, the NRC will immediately seek legal advice from its Office of the General Counsel concerning the impact of the Bankruptcy Code on any pending or contemplated collection activities. Unless the NRC determines that the automatic stay imposed at the time of filing pursuant to 11 U.S.C. 362 has been lifted or is no longer in effect, collection activity against the debtor will in most cases stop immediately.
(a) After seeking legal advice from its Office of the General Counsel, a proof of claim usually will be filed with the bankruptcy court or the Trustee.
(b) If the NRC is a secured creditor, it may seek relief from the automatic stay regarding its security, subject to the provisions and requirements of 11 U.S.C. 362.
(c) Offset is stayed in most cases by the automatic stay. However, the NRC will seek legal advice from its Office of the General Counsel to determine whether its payments to the debtor and payments of other agencies available for offset may be frozen by the agency until relief from the automatic stay can be obtained from the bankruptcy court. The NRC will seek legal advice from its Office of the General Counsel to determine if recoupment is available.
(a) The NRC may compromise a claim not in excess of the monetary limitation if it has not been referred to DOJ for litigation.
(b) Unless otherwise provided by law, when the principal balance of a debt, exclusive of interest, penalties, and administrative costs, exceeds $100,000 or any higher amount authorized by the Attorney General, the authority to accept the compromise rests with the DOJ. The NRC will evaluate the compromise offer, using the factors set forth in this part. If an offer to compromise any debt in excess of $100,000 is acceptable to the NRC, the NRC shall refer the debt to the Civil Division or other appropriate litigating division in the DOJ using a CCLR. The referral must include appropriate financial information and a recommendation for the acceptance of the compromise offer. DOJ approval is not required if the compromise offer is rejected by NRC.
A claim may be compromised for one or more of the reasons set forth below:
(a) The full amount cannot be collected because:
(1) The debtor is unable to pay the full amount within a reasonable time; or
(2) The debtor refuses to pay the claim in full and the Government is unable to enforce collection in full within a reasonable time by enforced collection proceedings.
(b) There is a real doubt concerning the Government's ability to prove its case in Court for the full amount claimed, either because of the legal issues involved or a bona fide dispute as to the facts.
(c) The cost of collecting the claim does not justify the enforced collection of the full amount. The NRC shall
(d) The NRC shall determine the debtor's inability to pay, the Government's ability to enforce collection, and the amounts that are acceptable in compromise in accordance with the FCCS, 31 CFR part 902.
(e) Compromises payable in installments are discouraged, but, if necessary, must be in the form of a legally enforceable agreement for the reinstatement of the prior indebtedness less sums paid thereon. The agreement also must provide that in the event of default—
(1) The entire balance of the debt becomes immediately due and payable; and
(2) The Government has the right to enforce any security interest.
(a) The NRC may accept a percentage of a debtor's profits or stock in a debtor corporation in compromise of a claim. In negotiating a compromise with a business concern, the NRC should consider requiring a waiver of tax-loss-carry-forward and tax-loss-carry-back rights of the debtor. For information on reporting requirements, see § 15.60.
(b) When two or more debtors are jointly and severally liable, the NRC will pursue collection activity against all debtors, as appropriate. The NRC will not attempt to allocate the burden of payment between the debtors but will proceed to liquidate the indebtedness as quickly as possible. The NRC will ensure that a compromise agreement with one debtor does not release the NRC's claim against the remaining debtors. The amount of a compromise with one debtor shall not be considered a precedent or binding in determining the amount that will be required from other debtors jointly and severally liable on the claim.
An offer of compromise must be in writing and signed by the debtor. An offer of compromise which is accepted by the NRC is final and conclusive on the debtor and on all officials, agencies, and courts of the United States, unless obtained by fraud, misrepresentation, the presentation of a false claim, or mutual mistake of fact.
(a) In all appropriate instances, a compromise that is accepted by NRC should be implemented by means of a mutual release.
(1) The debtor is released from further non-tax liability on the compromised debt in consideration of payment in full of the compromised amount.
(2) The Government and its officials, past and present, are released and discharged from any and all claims and causes of action arising from the same transaction held by the debtor.
(b) If a mutual release is not executed when a debt is compromised, unless prohibited by law, the debtor is still deemed to have waived any and all claims and causes of action against the Government and its officials related to the transaction giving rise to the compromised debt.
The NRC may suspend or terminate collection action on a claim not in excess of the monetary limitation of $100,000 or such other amount as the Attorney General may direct, exclusive of interest, penalties, and administrative costs, after deducting the amount of partial payments or collections, if any of the debt has not been referred to the DOJ for litigation. If, after deducting the amount of any partial payments or collections, the principal amount of a debt exceeds $100,000, or such other amount as the Attorney General may direct, exclusive of interest, penalties, and administrative
The NRC may suspend collection activity when:
(a) The NRC cannot locate the debtor;
(b) The debtor's financial condition is not expected to improve; or
(c) The debtor has requested a waiver or review of the debt.
(d) Based on the current financial condition of the debtor, the NRC may suspend collection activity on a debt when the debtor's future prospects justify retention of the debt for periodic review and collection activity and:
(1) The applicable statute of limitations has not expired; or
(2) Future collection can be effected by administrative offset, notwithstanding the expiration of the applicable statute of limitations for litigation of claims, with due regard to the 10-year limitation for administrative offset prescribed by 31 U.S.C. 3716(e)(1); or
(3) The debtor agrees to pay interest on the amount of the debt on which collection will be suspended, and such suspension is likely to enhance the debtor's ability to pay the full amount of the principal of the debt with interest at a later date.
(e)(1) The NRC shall suspend collection activity during the time required for consideration of the debtor's request for waiver or administrative review of the debt, if the statute under which the request is sought prohibits the NRC from collecting the debt during that time.
(2) If the statute under which the request is sought does not prohibit collection activity pending consideration of the request, the NRC may use discretion, on a case-by-case basis, to suspend collection. Further, the NRC ordinarily should suspend collection action upon a request for waiver or review, if the NRC is prohibited by statute or regulation from issuing a refund of amounts collected prior to NRC consideration of the debtor's request. However, the NRC should not suspend collection when the NRC determines that the request for waiver or review is frivolous or was made primarily to delay collection.
(f) When the NRC learns that a bankruptcy petition has been filed with respect to a debtor, in most cases, the collection activity on a debt must be suspended, pursuant to the provisions of 11 U.S.C. 362, 1201, and 1301, unless the NRC can clearly establish that the automatic stay has been lifted or is no longer in effect. The NRC should seek legal advice immediately from its Office of the General Counsel and, if legally permitted, take the necessary steps to ensure that no funds or money are paid by the NRC to the debtor until relief from the automatic stay is obtained.
The NRC may terminate collection activity when:
(a) The NRC is unable to collect any substantial amount through its own efforts or through the efforts of others;
(b) The NRC is unable to locate the debtor;
(c) Costs of collection are anticipated to exceed the amount recoverable,
(d) The debt is legally without merit or enforcement of the debt is barred by any applicable statute of limitations;
(e) The debt cannot be substantiated; or
(f) The debt against the debtor has been discharged in bankruptcy.
(a) Before terminating collection activity, the NRC should have pursued all appropriate means of collection and determined, based upon the results of the collection activity, that the debt is uncollectible. Termination of collection activity ceases active collection of the debt. The termination of collection activity does not preclude the NRC from retaining a record of the account for purposes of:
(1) Selling the debt, if the Treasury determines that such sale is in the best interests of the United States;
(2) Pursuing collection at a subsequent date in the event there is a change in the debtor's status or a new collection tool becomes available;
(3) Offsetting against future income or assets not available at the time of termination of collection activity; or
(4) Screening future applicants for prior indebtedness.
(b) Generally, the NRC will terminate collection activity on a debt that has been discharged in bankruptcy, regardless of the amount. However, the NRC may continue collection activity, subject to the provisions of the Bankruptcy Code, for any payments provided under a plan of reorganization.
When a significant enforcement policy is involved, or recovery of a judgment is a prerequisite to the imposition of administrative sanctions, the NRC may refer debts for litigation, although termination of collection activity may be appropriate.
(a) Before discharging a delinquent debt (also referred to as a close out of the debt), the NRC shall take all appropriate steps to collect the debt in accordance with 31 U.S.C. 3711(g), including, as applicable, administrative offset; tax refund offset; Federal salary offset; referral to Treasury, Treasury-designated debt collection centers, or private collection contractors; credit bureau reporting; wage garnishment; litigation; and foreclosure. Discharge of indebtedness is distinct from termination or suspension of collection activity under 10 CFR 15.55 and 15.57 and is governed by the Internal Revenue Code. When collection action on a debt is suspended or terminated, the debt remains delinquent, and further collection action may be pursued at a later date. When the NRC discharges a debt in full or in part, further collection action is prohibited. Therefore, the NRC will make the determination that collection action is no longer warranted before discharging a debt. Before discharging a debt, the NRC must terminate debt collection action.
(b) Section 3711(i), title 31, United States Code, requires agencies to sell a delinquent nontax debt upon termination of collection action if Treasury determines such a sale is in the best interests of the United States. Since the discharge of a debt precludes any further collection action (including the sale of a delinquent debt), the NRC may not discharge a debt until the requirements of 31 U.S.C. 3711(i) have been met.
(c) Upon discharge of an indebtedness, the NRC shall report the discharge to the IRS in accordance with the requirements of 26 U.S.C. 6050P and 26 CFR 1.6050P-1. The NRC may request Treasury or a Treasury-designated debt collection center to file a discharge report to the IRS on the NRC's behalf.
(d) When discharging a debt, the NRC shall request that litigation counsel release any liens of record securing the debt.
(a) The NRC shall promptly refer debts that are subject to aggressive collection activity (as described in subpart B of this part) and that cannot be compromised, or debts on which collection activity cannot be suspended or terminated, to DOJ for litigation. Debts for which the principal amount exceeds $1,000,000, or such other amount as the Attorney General may
(b) DOJ has exclusive jurisdiction over the debts referred to in paragraph (a) of this section. The NRC shall terminate the use of any administrative collection activities to collect a debt when the debt is referred to DOJ. The NRC shall advise the DOJ of the collection activities it used and the results. The NRC shall refrain from having any contact with the debtor and shall direct all inquiries to DOJ. The NRC shall immediately notify DOJ of any payments credited to the debtor's account after the account has been referred to DOJ. DOJ shall notify NRC in a timely manner of any payments it receives from the debtor.
The NRC may refer a debtor's firm written offer of compromise, which is substantial in amount, to the Civil Division or other appropriate litigating division in DOJ using a CCLR accompanied by supporting data and particulars concerning the debt.
(a) Unless excepted by DOJ, the NRC shall complete the CCLR accompanied by a Certificate of Indebtedness, to refer all administratively uncollectible claims to the DOJ for litigation.
(b) The NRC shall indicate the actions it wishes DOJ to take regarding the referred claim on the CCLR.
(c) Before referring a debt to DOJ for litigation, the NRC shall notify each person determined to be liable for the debt that, unless the debt can be collected administratively, litigation may be initiated. This notification must comply with Executive Order 12988 (3 CFR, 1996 Comp., pp 157-163) and may be given as part of a demand letter or as a separate document.
(d) The NRC shall preserve all files and records that DOJ may need to prove the claim in court.
(e) The NRC may ordinarily not refer for litigation claims of less than $2,500, exclusive of interest, penalties, and administrative charges, or such other amount as the Attorney General shall from time to time prescribe.
(f) The NRC may not refer claims of less than the minimum amount unless:
(1) Litigation to collect a smaller claim is important to ensure compliance with NRC's policies and programs;
(2) The claim is being referred solely to secure a judgment against the debtor, which will be filed as a lien against the debtor's property under 28 U.S.C. 3201 and returned to the NRC for enforcement, or
(3) The debtor has the clear ability to pay the claim, and the Government effectively can enforce payment, with due regard for the exemptions available to the debtor under state and Federal law and the judicial remedies available to the Government.
Secs. 161, 186, 68 Stat. 948, 955, as amended (42 U.S.C. 2201, 2236); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1, Pub. L. 97-258, 96 Stat. 972 (31 U.S.C. 3713); sec 5, Pub. L. 89-508, 80 Stat. 308, as amended (31 U.S.C. 3711, 3717, 3718); Pub. L. 97-365, 96 Stat. 1749; Federal Claims Collection Standards, 31 CFR Chapter IX, Parts 900-904; 31 U.S.C. Secs. 3701, 3716; 31 CFR Sec 285; 26 U.S.C. Sec 6402(d); 31 U.S.C. Sec. 3720A; 26 U.S.C. Sec. 6402(c); 42 U.S.C. Sec. 664; Pub. L. 104-134, as amended (31 U.S.C. 3713); 5 U.S.C. 5514; Executive Order 12988 (3 CFR, 1996 Comp., pp. 157-163); 5 CFR 550.
(a) This part provides procedures for the collection by administrative offset of a Federal employee's salary without his/her consent to satisfy certain debts owed to the Federal Government. This part applies to all Federal employees who owe debts to the Nuclear Regulatory Commission (NRC) and to current employees of the NRC who owe debts to other Federal agencies. This part does not apply when the employee consents to recovery from his/her current pay account.
(b) These procedures do not apply to debts or claims arising under:
(1) The Internal Revenue Code of 1954, as amended, 26 U.S.C. 1
(2) The tariff laws of the United States; or
(3) Any case where a collection of a debt by salary offset is explicitly provided for or prohibited by another statute.
(c) These procedures do not apply to any adjustment to pay arising out of an employee's selection of coverage or a change in coverage under a Federal benefits program requiring periodic deductions from pay if the amount to be recovered was accumulated over four pay periods or less.
(d) These procedures do not preclude the compromise, suspension, or termination of collection action where appropriate under the standards implementing the revised Federal Claims Collection Standards (FCCS), 31 U.S.C. 3711
(e) This part does not preclude an employee from requesting waiver of an overpayment under 5 U.S.C. 5584, 10 U.S.C. 2774, or 32 U.S.C. 716 or in any way questioning the amount or validity of the debt by submitting a subsequent claim to the NRC. This part does not preclude an employee from requesting a waiver pursuant to other statutory provisions applicable to the particular debt being collected.
(f) The NRC is not limited to collection remedies contained in the revised FCCS. The FCCS is not intended to impair common law remedies.
For the purposes of this part, the following definitions apply:
(1) Any amount required by law to be withheld;
(2) Amounts properly withheld for Federal, state or local income tax purposes;
(3) Amounts deducted as health insurance premiums;
(4) Amounts deducted as normal retirement contributions, not including amounts deducted for supplementary coverage; and
(5) Amounts deducted as normal life insurance premiums not including amounts deducted for supplementary coverage.
The regulations in this part are to be followed when:
(a) The NRC is owed a debt by an individual currently employed by another Federal agency;
(b) The NRC is owed a debt by an individual who is a current employee of the NRC; or
(c) The NRC employs an individual who owes a debt to another Federal agency.
(a) If the NRC is the creditor agency, deductions will not be made unless the NRC provides the employee with a signed written notice of the debt at least 30 days before salary offset commences. The notice will be delivered in person or by certified or registered mail, return receipt requested, with receipt returned as proof of delivery.
(b) The written notice must contain:
(1) A statement that the debt is owed and an explanation of its origin, nature, and amount;
(2) The NRC's intention to collect the debt by deducting from the employee's current disposable pay account;
(3) The amount and frequency of the intended deduction (stated as a fixed dollar amount or as a percentage of pay, not to exceed 15 percent of disposable pay) and the intention to continue the deduction until the debt is paid in full or otherwise resolved.
(4) An explanation of interest, penalties, and administrative charges, including a statement that these charges will be assessed unless excused in accordance with the Federal Claims Collection Standards at 4 CFR parts 101-105;
(5) The employee's right to inspect and copy government records pertaining to the debt or, if the employee or his or her representative cannot personally inspect the records, to request and receive a copy of these records;
(6) If not previously provided, the opportunity (under terms agreeable to the NRC) to establish a schedule for the voluntary repayment of the debt or to enter into a written agreement to establish a schedule for repayment of the debt in lieu of offset (31 CFR Chapter IX, 901.2). The agreement must be in writing, signed by the employee and the NRC, and documented in the NRC's files.
(7) The employee's right to a hearing conducted by an official arranged for by the NRC (an administrative law judge, or alternatively, a hearing official not under the control of the head of the agency) if a petition is filed as prescribed in § 16.9;
(8) The methods and time period for petitioning for hearings;
(9) A statement that the timely filing of a petition for a hearing will stay the commencement of collection proceedings;
(10) A statement that a final decision on the hearing will be issued not later than 60 days after the filing of the petition requesting the hearing unless the employee requests and the hearing official grants a delay in the proceedings;
(11) A statement that knowingly false or frivolous statements, representations, or evidence may subject the employee to appropriate disciplinary procedures under chapter 75 of title 5, United States Code and 5 CFR part 752, penalties under the False Claims Act, sections 3729-3731 of title 31, United States Code or other applicable statutory authority, or criminal penalties under section 286, 287, 1001 and 1002 of title 18, United States Code or any other applicable statutory authority;
(12) A statement of other rights and remedies available to the employee under statutes or regulations governing the program for which the collection is being made; and
(13) Unless there are contractual or statutory provisions to the contrary, a statement that amounts paid on or deducted for the debt which are later waived or found not owed to the United States will be promptly refunded to the employee.
This part contains no information collection requirements, and, therefore, is not subject to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501
(a)
(2) If the NRC is the creditor agency, a hearing may be requested by filing a written petition stating why the employee disputes the existence or amount of the debt or the repayment schedule if it was not established by written agreement between the employee and the NRC. The employee shall sign the petition and fully identify and explain with reasonable specificity all the facts, evidence, and witnesses, if any, which the employee believes support his or her position. The petition for a hearing must be received no later than fifteen (15) calendar days after receipt of the notice of offset unless the employee can show that the delay in meeting the deadline date was because of circumstances beyond his or her control or because of failure to receive notice of the time limit (unless otherwise aware of it).
(b)
(2) The hearing must conform to procedures contained in the revised FCCS, 31 CFR Chapter IX, 901.3(e). The burden
(3) An employee is entitled to representation of his or her choice at any stage of the proceeding. NRC attorneys may not be provided as representatives for the debtor. The NRC will not compensate the debtor for representation expenses, including hourly fees for attorneys, travel expenses, and costs for reproducing documents.
(a) The hearing official will issue a written opinion no later than 60 days after the hearing.
(b) The written opinion must include:
(1) A statement of the facts presented to demonstrate the nature and origin of the alleged debt;
(2) The hearing official's analysis, findings, and conclusions;
(3) The amount and validity of the debt; and
(4) The repayment schedule, where appropriate.
(a) The NRC must notify Treasury of all debts that are delinquent as defined in the FCCS (over 180 days old) so that recovery may be made by centralized administrative offset. This includes those debts the NRC seeks to recover from the pay account of an employee of another agency via salary offset. The Treasury and other Federal disbursing officials will match payments, including Federal salary payments, against such debts. When a match occurs, and all the requirements for offset have been met, the payments will be offset to collect the debt. Prior to offset of the pay account of an employee, the NRC must comply with the requirements of 5 U.S.C. 5514, 5 CFR part 550, and 10 CFR part 15. Procedures for notifying Treasury of a debt for purposes of collection by centralized administrative offset are contained in 31 CFR part 285 and 10 CFR 15.33. Procedures for internal salary offset are contained in § 16.15 of this chapter.
(b) When the NRC determines that an employee of another Federal agency owes a delinquent debt to the NRC, the NRC will, as appropriate:
(1) Arrange for a hearing upon the proper petitioning by the employee;
(2) Provide the Federal employee with a notice and an opportunity to dispute the debt as contained in 5 U.S.C. 5514 and 10 CFR 15.26.
(3) Submit the debt to Treasury for centralized administrative offset and certify in writing that the debtor has been afforded the legally required due process notification.
(4) If collection must be made in installments, the NRC must advise the paying agency of the amount or percentage of disposable pay to be collected in each installment.
(c)
(i) The amount of the debt, including any interest, penalties, and administrative costs; or
(ii) An amount up to 15 percent of the debtor's disposable pay.
(2) Alternatively, the amount offset may be an amount agreed upon, in writing, by the debtor and the NRC.
(3) Offsets will continue until the debt, including any interest, penalties, and administrative costs, is paid in full or otherwise resolved to the satisfaction of the NRC.
(d)
(2) When a salary payment may be reduced to collect more than one debt, amounts offset under this section will be applied to a debt only after amounts offset have been applied to satisfy past due child support debt assigned to a State pursuant 26 U.S.C. 6402(c) and 31 CFR 285.7(h)(2).
(e)
(2)(i) When an offset occurs under this section, the disbursing official, or the paying agency on behalf of the disbursing official, shall notify the Federal employee in writing that an offset has occurred including:
(A) A description of the payment and the amount of the offset taken;
(B) Identification of NRC as the agency requesting the offset; and,
(C) A contact point within the NRC that will handle concerns regarding the offset.
(ii) The information described in paragraphs (e)(2)(i)(B) and (e)(2)(i)(C) of this section does not need to be provided to the Federal employee when the offset occurs if such information was included in a prior notice from the disbursing official or paying agency.
(3) The disbursing official will advise the NRC of the names, mailing addresses, and taxpayer identifying numbers of the debtors from whom amounts of past-due, legally enforceable debt were collected and of the amounts collected from each debtor. The disbursing official will not advise the NRC of the source of payment from which such amounts were collected.
(f)
(g)
(a) Deductions to liquidate an employee's debt will be by the method and in the amount stated in the NRC's notice of intention to offset as provided in § 16.7. Debts will be collected in one lump sum where possible. If the employee is financially unable to pay in one lump sum, collection must be made in installments.
(b) Debts will be collected by deduction at officially established pay intervals from an employee's current pay account unless alternative arrangements for repayment are made.
(c) Installment deductions will be made over a period not greater than the anticipated period of employment. The size of installment deductions must bear a reasonable relationship to the size of the debt and the employee's ability to pay. The deduction for the pay intervals for any period may not exceed 15% of disposable pay unless the employee has agreed in writing to a deduction of a greater amount.
(d) Offset against any subsequent payment due an employee who retires or resigns or whose employment or period of active duty ends before collection of the debt is completed is provided for in accordance with 31 U.S.C. 3716. These payments include but are not limited to final salary payment or lump-sum leave due the employee from the paying agency as of the date of separation to the extent necessary to liquidate the debt.
(a) The NRC will refund promptly any amounts deducted to satisfy debts owed to the NRC when the debt is waived, found not owed to the NRC, or when directed by an administrative or Judicial order.
(b) The creditor agency will promptly return any amounts deducted by NRC to satisfy debts owed to the creditor agency when the debt is waived, found
(c) Unless required or permitted by law or contract, refunds under this section may not bear interest.
If a debt has been outstanding for more than 10 years after the agency's right to collect the debt first accrued, the agency may not collect by salary offset unless facts material to the Government's right to collect were not known and could not reasonably have been known by the NRC official or officials who were charged with the responsibility for discovery and collection of the debts.
An employee's involuntary payment of all or any part of a debt collected under these regulations will not be construed as a waiver of any rights that the employee may have under 5 U.S.C. 5514 or any other provision of contract or law, unless there are statutes or contract(s) to the contrary.
Charges may be assessed for interest, penalties, and administrative charges in accordance with the FCCS, 31 CFR Chapter IX, 901.9.
Secs. 53, 63, 81, 103, 104, 161, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 955, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2236, 2282, 2297f); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851).
The regulations in this part establish requirements for notices, instructions, and reports by licensees to individuals participating in licensed activities and options available to these individuals in connection with Commission inspections of licensees to ascertain compliance with the provisions of the Atomic Energy Act of 1954, as amended, title II of the Energy Reorganization Act of 1974, and regulations, orders, and licenses thereunder regarding radiological working conditions. The regulations in this part also establish the rights and responsibilities of the Commission and individuals during interviews compelled by subpoena as part of agency inspections or investigations pursuant to section 161c of the Atomic Energy Act of 1954, as amended, on any matter within the Commission's jurisdiction.
The regulations in this part apply to all persons who receive, possess, use, or transfer material licensed by the Nuclear Regulatory Commission pursuant to the regulations in parts 30 through 36, 39, 40, 60, 61, 63, 70, or part 72 of this chapter, including persons licensed to operate a production or utilization facility under part 50 of this chapter, persons licensed to possess power reactor spent fuel in an independent spent fuel storage installation (ISFSI) pursuant to part 72 of this chapter, and in accordance with 10 CFR 76.60 to persons
As used in this part:
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
Except where otherwise specified in this part, all communications and reports concerning the regulations in this part should be addressed to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in Appendix D of part 20 of this chapter. Communications, reports, and applications may be delivered in person at the Commission's offices at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0044.
(b) The approved information collection requirements contained in this part appear in §§ 19.13 and 19.16.
(a) Each licensee shall post current copies of the following documents:
(1) The regulations in this part and in part 20 of this chapter;
(2) The license, license conditions, or documents incorporated into a license by reference, and amendments thereto;
(3) The operating procedures applicable to licensed activities;
(4) Any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued pursuant to subpart B of part 2 of this chapter, and any response from the licensee.
(b) If posting of a document specified in paragraph (a) (1), (2) or (3) of this section is not practicable, the licensee may post a notice which describes the document and states where it may be examined.
(c)(1) Each licensee and each applicant for a specific license shall prominently post NRC Form 3, “Notice to Employees,” dated August 1997. Later versions of NRC Form 3 that supersede the August 1997 version shall replace the previously posted version within 30 days of receiving the revised NRC Form 3 from the Commission.
(2) Additional copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D to part 20 of this chapter or by calling the NRC Information and Records Management Branch at 301-415-7232.
(d) Documents, notices, or forms posted pursuant to this section shall appear in a sufficient number of places to permit individuals engaged in licensed activities to observe them on the way to or from any particular licensed activity location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.
(e) Commission documents posted pursuant to paragraph (a)(4) of this section shall be posted within 2 working days after receipt of the documents from the Commission; the licensee's response, if any, shall be posted within 2 working days after dispatch by the licensee. Such documents shall remain posted for a minimum of 5 working days or until action correcting the violation has been completed, whichever is later.
(a) All individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) shall be—
(1) Kept informed of the storage, transfer, or use of radiation and/or radioactive material;
(2) Instructed in the health protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;
(3) Instructed in, and required to observe, to the extent within the workers control, the applicable provisions of Commission regulations and licenses for the protection of personnel from exposure to radiation and/or radioactive material;
(4) Instructed of their responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or unnecessary exposure to radiation and/or radioactive material;
(5) Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material; and
(6) Advised as to the radiation exposure reports which workers may request pursuant to § 19.13.
(b) In determining those individuals subject to the requirements of paragraph (a) of this section, licensees must take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to
(a) Radiation exposure data for an individual, and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual, shall be reported to the individual as specified in this section. The information reported shall include data and results obtained pursuant to Commission regulations, orders or license conditions, as shown in records maintained by the licensee pursuant to Commission regulations. Each notification and report shall: be in writing; include appropriate identifying data such as the name of the licensee, the name of the individual, the individual's social security number; include the individual's exposure information; and contain the following statement:
This report is furnished to you under the provisions of the Nuclear Regulatory Commission regulation 10 CFR part 19. You should preserve this report for further reference.
(b) Each licensee shall advise each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of § 20.2106 of 10 CFR part 20.
(c)(1) At the request of a worker formerly engaged in licensed activities controlled by the licensee, each licensee shall furnish to the worker a report of the worker's exposure to radiation and/or to radioactive material:
(i) As shown in records maintained by the licensee pursuant to § 20.2106 for each year the worker was required to be monitored under the provisions of § 20.1502; and
(ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to January 1, 1994.
(2) This report must be furnished within 30 days from the time the request is made or within 30 days after the exposure of the individual has been determined by the licensee, whichever is later. This report must cover the period of time that the worker's activities involved exposure to radiation from radioactive material licensed by the Commission and must include the dates and locations of licensed activities in which the worker participated during this period.
(d) When a licensee is required pursuant to §§ 20.2202, 20.2203, 20.2204, or 20.2206 of this chapter to report to the Commission any exposure of an individual to radiation or radioactive material the licensee shall also provide the individual a report on his or her exposure data included therein. This report must be transmitted at a time not later than the transmittal to the Commission.
(e) At the request of a worker who is terminating employment with the licensee that involved exposure to radiation or radioactive materials, during the current calendar quarter or the current year, each licensee shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.
(a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect materials, activities, facilities, premises, and records pursuant to the regulations in this chapter.
(b) During an inspection, Commission inspectors may consult privately with workers as specified in § 19.15. The licensee or licensee's representative may accompany Commission inspectors during other phrases of an inspection.
(c) If, at the time of inspection, an individual has been authorized by the
(d) Each workers’ representative shall be routinely engaged in licensed activities under control of the licensee and shall have received instructions as specified in § 19.12.
(e) Different representatives of licensees and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers’ representative at a time may accompany the inspectors.
(f) With the approval of the licensee and the workers’ representative an individual who is not routinely engaged in licensed activities under control of the license, for example, a consultant to the licensee or to the workers’ representative, shall be afforded the opportunity to accompany Commission inspectors during the inspection of physical working conditions.
(g) Notwithstanding the other provisions of this section, Commission inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the U.S. Government in the interest of national security, an individual who accompanies an inspector may have access to such information only if authorized to do so. With regard to any area containing proprietary information, the workers’ representative for that area shall be an individual previously authorized by the licensee to enter that area.
(a) Commission inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of Commission regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.
(b) During the course of an inspection any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which he has reason to believe may have contributed to or caused any violation of the act, the regulations in this chapter, or license condition, or any unnecessary exposure of an individual to radiation from licensed radioactive material under the licensee's control. Any such notice in writing shall comply with the requirements of § 19.16(a).
(c) The provisions of paragraph (b) of this section shall not be interpreted as authorization to disregard instructions pursuant to § 19.12.
(a) Any worker or representative of workers who believes that a violation of the Act, the regulations in this chapter, or license conditions exists or has occurred in license activities with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Administrator of the appropriate Commission Regional Office, or to Commission inspectors. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of workers. A copy shall be provided the licensee by the Regional Office Administrator, or the inspector no later than at the time of inspection except that, upon the request of the worker giving such notice, his name and the name of individuals referred to therein shall not appear in such copy or on any record published, released or made available by the Commission, except for good cause shown.
(b) If, upon receipt of such notice, the Regional Office Administrator determines that the complaint meets the requirements set forth in paragraph (a) of this section, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, he shall cause an inspection to be made as soon as practicable, to determine if such alleged violation exists or has occurred. Inspections pursuant to this
(a) If the Administrator of the appropriate Regional Office determines, with respect to a complaint under § 19.16, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, he shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the Executive Director for Operation, U.S. Nuclear Regulatory Commission, Washington, DC 20555, who will provide the licensee with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee may submit an opposing written statement of position with the Executive Director for Operations who will provide the complainant with a copy of such statement by certified mail. Upon the request of the complainant, the Executive Director for Operations or his designee may hold an informal conference in which the complainant and the licensee may orally present their views. An informal conference may also be held at the request of the licensee, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written and oral views presented, the Executive Director for Operations shall affirm, modify, or reverse the determination of the Administrator of the appropriate Regional Office and furnish the complainant and the licensee a written notification of his decision and the reason therefor.
(b) If the Administrator of the appropriate Regional Office determines that an inspection is not warranted because the requirements of § 19.16(a) have not been met, he shall notify the complainant in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of § 19.16(a).
(a) All witnesses compelled by subpoena to submit to agency interviews shall be sequestered unless the official conducting the interviews permits otherwise.
(b) Any witness compelled by subpoena to appear at an interview during an agency inquiry may be accompanied, represented, and advised by counsel of his or her choice. However, when the agency official conducting the inquiry determines, after consultation with the Office of the General Counsel, that the agency has concrete evidence that the presence of an attorney representing multiple interests would obstruct and impede the investigation or inspection, the agency official may prohibit that counsel from being present during the interview.
(c) The interviewing official is to provide a witness whose counsel has been excluded under paragraph (b) of this section and the witness's counsel a written statement of the reasons supporting the decision to exclude. This statement, which must be provided no later than five working days after exclusion, must explain the basis for the counsel's exclusion. This statement must also advise the witness of the witness’ right to appeal the exclusion decision and obtain an automatic stay of the effectiveness of the subpoena by filing a motion to quash the subpoena with the Commission within five days of receipt of this written statement.
(d) Within five days after receipt of the written notification required in paragraph (c) of this section, a witness whose counsel has been excluded may appeal the exclusion decision by filing a motion to quash the subpoena with the Commission. The filing of the motion to quash will stay the effectiveness of the subpoena pending the Commission's decision on the motion.
(e) If a witness’ counsel is excluded under paragraph (b) of this section, the interview may, at the witness’ request,
Employment discrimination by a licensee (or a holder of a certificate of compliance issued pursuant to part 76) or a contractor or subcontractor of a licensee (or a holder of a certificate of compliance issued pursuant to part 76) against an employee for engaging in protected activities under this part or parts 30, 40, 50, 60, 61, 63, 70, 72, 76, or 150 of this chapter is prohibited.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
The Commission may upon application by any licensee or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not result in undue hazard to life or property.
No person shall on the ground of sex be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity licensed by the Nuclear Regulatory Commission. This provision will be enforced through agency provisions and rules similar to those already established, with respect to racial and other discrimination, under Title VII of the Civil Rights Act of 1964. This remedy is not exclusive, however, and will not prejudice or cut off any other legal remedies available to a discriminatee.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 19 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 19 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 19.1, 19.2, 19.3, 19.4, 19.5, 19.8, 19.16, 19.17, 19.18, 19.30, 19.31, and 19.40.
Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
(a) The regulations in this part establish standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the Nuclear Regulatory Commission. These regulations are issued under the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended.
(b) It is the purpose of the regulations in this part to control the receipt, possession, use, transfer, and disposal of licensed material by any licensee in such a manner that the total dose to an individual (including doses resulting from licensed and unlicensed radioactive material and from radiation sources other than background radiation) does not exceed the standards for protection against radiation prescribed in the regulations in this part. However, nothing in this part shall be construed as limiting actions that may be necessary to protect health and safety.
The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under Parts 30 through 36, 39, 40, 50, 60, 61, 63, 70, or 72 of this chapter, and in accordance with 10 CFR 76.60 to persons required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter. The limits in this part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released under § 35.75, or to exposure from voluntary participation in medical research programs.
As used in this part:
(1) In excess of the derived air concentrations (DACs) specified in appendix B, to §§ 20.1001-20.2401, or
(2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours.
(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material; and
(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute
(1) Release of the property for unrestricted use and termination of the license; or
(2) Release of the property under restricted conditions and the termination of the license.
(1) The assessment of dose equivalent by the use of devices designed to be worn by an individual;
(2) The assessment of committed effective dose equivalent by bioassay (see
(3) The assessment of dose equivalent by the use of survey data.
(1) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission or the Department of Energy (except that the Department shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission under section
(2) Any legal successor, representative, agent, or agency of the foregoing.
(1) Uranium or thorium or any combination of uranium and thorium in any physical or chemical form; or
(2) Ores that contain, by weight, one-twentieth of 1 percent (0.05 percent), or more, of uranium, thorium, or any combination of uranium and thorium. Source material does not include special nuclear material.
(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Commission, pursuant to the provisions of section 51 of the Act, determines to be special nuclear material, but does not include source material; or
(2) Any material artificially enriched by any of the foregoing but does not include source material.
At very high doses received at high dose rates, units of absorbed dose (e.g., rads and grays) are appropriate, rather than units of dose equivalent (e.g., rems and sieverts)).
(a) Definitions. As used in this part, the units of radiation dose are:
(b) As used in this part, the quality factors for converting absorbed dose to dose equivalent are shown in table 1004(b).1.
(c) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent
For the purposes of this part, activity is expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), or their multiples, or disintegrations (transformations) per unit of time.
(a) One becquerel = 1 disintegration per second (s
(b) One curie = 3.7×10
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by an officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
Unless otherwise specified, communications or reports concerning the regulations in this part should be addressed to the Executive Director for Operations, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A communication, report, or application may be delivered in person to the Office of the Executive Director for Operations, 11555 Rockville Pike, Rockville, MD 20852.
(a) [Reserved]
(b) The applicable section of §§ 20.1001-20.2402 must be used in lieu of requirements in the standards for protection against radiation in effect prior to January 1, 1994
(c) Any existing license condition or technical specification that is more restrictive than a requirement in §§ 20.1001-20.2402 remains in force until there is a technical specification change, license amendment, or license renewal.
(d) If a license condition or technical specification exempted a licensee from a requirement in the standards for protection against radiation in effect prior
(e) If a license condition cites provisions in requirements in the standards for protection against radiation in effect prior to January 1, 1994
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501
(b) The approved information collection requirements contained in this part appear in §§ 20.1003, 20.1101, 20.1202, 20.1203, 20.1204, 20.1206, 20.1208, 20.1301, 20.1302, 20.1403, 20.1404, 20.1406, 20.1501, 20.1601, 20.1703, 20.1901, 20.1904, 20.1905, 20.1906, 20.2002, 20.2004, 20.2005, 20.2006, 20.2102, 20.2103, 20.2104, 20.2105, 20.2106, 20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 20.2205, 20.2206, 20.2301, and appendix G to this part.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In § 20.2104, NRC Form 4 is approved under control number 3150-0005.
(2) In §§ 20.2106 and 20.2206, NRC Form 5 is approved under control number 3150-0006.
(3) In § 20.2006 and appendix G to 10 CFR part 20, NRC Form 540 and 540A is approved under control number 3150-0164.
(4) In § 20.2006 and appendix G to 10 CFR part 20, NRC Form 541 and 541A is approved under control number 3150-0166.
(5) In § 20.2006 and appendix G to 10 CFR part 20, NRC Form 542 and 542A is approved under control number 3150-0165.
(a) Each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of this part. (See § 20.2102 for recordkeeping requirements relating to these programs.)
(b) The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).
(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.
(d) To implement the ALARA requirements of § 20.1101 (b), and notwithstanding the requirements in § 20.1301 of this part, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to § 50.34a, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in § 20.2203 and promptly take appropriate
(a) The licensee shall control the occupational dose to individual adults, except for planned special exposures under § 20.1206, to the following dose limits.
(1) An annual limit, which is the more limiting of—
(i) The total effective dose equivalent being equal to 5 rems (0.05 Sv); or
(ii) The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems (0.5 Sv).
(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:
(i) A lens dose equivalent of 15 rems (0.15 Sv), and
(ii) A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity.
(b) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year (see § 20.1206(e)(1)) and during the individual's lifetime (see § 20.1206(e)(2)).
(c) The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent must be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.
(d) Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in table 1 of appendix B to part 20 and may be used to determine the individual's dose (see § 20.2106) and to demonstrate compliance with the occupational dose limits.
(e) In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (see footnote 3 of appendix B to part 20).
(f) The licensee shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person (see § 20.2104(e)).
(a) If the licensee is required to monitor under both §§ 20.1502 (a) and (b), the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under § 20.1502(a) or only under § 20.1502(b), then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (b) of this section and the conditions in paragraphs (c) and (d) of this section.
The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.)
(b)
(1) The sum of the fractions of the inhalation ALI for each radionuclide, or
(2) The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or
(3) The sum of the calculated committed effective dose equivalents to all significantly irradiated
(c)
(d)
The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated.
Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent from external exposure to the radioactive cloud (see appendix B to part 20, footnotes 1 and 2).
Airborne radioactivity measurements and DAC values should not be used as the primary means to assess the deep-dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep-dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.
(a) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under § 20.1502, take suitable and timely measurements of—
(1) Concentrations of radioactive materials in air in work areas; or
(2) Quantities of radionuclides in the body; or
(3) Quantities of radionuclides excreted from the body; or
(4) Combinations of these measurements.
(b) Unless respiratory protective equipment is used, as provided in § 20.1703, or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.
(c) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior or the material in an individual is known, the licensee may—
(1) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and
(2) Upon prior approval of the Commission, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material (e.g., aerosol size distribution or density); and
(3) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide (see appendix B to part 20) to the committed effective dose equivalent.
(d) If the licensee chooses to assess intakes of Class Y material using the measurements given in § 20.1204(a)(2) or (3), the licensee may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by §§ 20.2202 or 20.2203, in order to permit the licensee to make
(e) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours must be either—
(1) The sum of the ratios of the concentration to the appropriate DAC value (e.g., D, W, Y) from appendix B to part 20 for each radio-nuclide in the mixture; or
(2) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.
(f) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture must be the most restrictive DAC of any radionuclide in the mixture.
(g) When a mixture of radionuclides in air exists, licensees may disregard certain radionuclides in the mixture if—
(1) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in § 20.1201 and in complying with the monitoring requirements in § 20.1502(b), and
(2) The concentration of any radionuclide disregarded is less than 10 percent of its DAC, and
(3) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent.
(h)(1) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 5 rems (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent.
(2) When the ALI (and the associated DAC) is determined by the nonstochastic organ dose limit of 50 rems (0.5 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) (the stochastic ALI) is listed in parentheses in table 1 of appendix B to part 20. In this case, the licensee may, as a simplifying assumption, use the stochastic ALIs to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALIs, the licensee must also demonstrate that the limit in § 20.1201(a)(1)(ii) is met.
A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in § 20.1201 provided that each of the following conditions is satisfied—
(a) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.
(b) The licensee (and employer if the employer is not the licensee) specifically authorizes the planned special exposure, in writing, before the exposure occurs.
(c) Before a planned special exposure, the licensee ensures that the individuals involved are—
(1) Informed of the purpose of the planned operation;
(2) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and
(3) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.
(d) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by § 20.2104(b) during the lifetime of the individual for each individual involved.
(e) Subject to § 20.1201(b), the licensee does not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed—
(1) The numerical values of any of the dose limits in § 20.1201(a) in any year; and
(2) Five times the annual dose limits in § 20.1201(a) during the individual's lifetime.
(f) The licensee maintains records of the conduct of a planned special exposure in accordance with § 20.2105 and submits a written report in accordance with § 20.2204.
(g) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures is not to be considered in controlling future occupational dose of the individual under § 20.1201(a) but is to be included in evaluations required by § 20.1206 (d) and (e).
The annual occupational dose limits for minors are 10 percent of the annual dose limits specified for adult workers in § 20.1201.
(a) The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy, due to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see § 20.2106.)
(b) The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (a) of this section.
(c) The dose equivalent to the embryo/fetus is the sum of—
(1) The deep-dose equivalent to the declared pregnant woman; and
(2) The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.
(d) If the dose equivalent to the embryo/fetus is found to have exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with paragraph (a) of this section if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
(a) Each licensee shall conduct operations so that —
(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with § 20.2003, and
(2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.
(b) If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.
(c) Notwithstanding paragraph (a)(1) of this section, a licensee may permit visitors to an individual who cannot be released, under § 35.75, to receive a radiation dose greater than 0.1 rem (1 mSv) if—
(1) The radiation dose received does not exceed 0.5 rem (5 mSv); and
(2) The authorized user, as defined in 10 CFR Part 35, has determined before the visit that it is appropriate.
(d) A licensee or license applicant may apply for prior NRC authorization to operate up to an annual dose limit for an individual member of the public
(1) Demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (a) of this section;
(2) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and
(3) The procedures to be followed to maintain the dose as low as is reasonably achievable.
(e) In addition to the requirements of this part, a licensee subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190 shall comply with those standards.
(f) The Commission may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.
(a) The licensee shall make or cause to be made, as appropriate, surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in § 20.1301.
(b) A licensee shall show compliance with the annual dose limit in § 20.1301 by—
(1) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or
(2) Demonstrating that—
(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in table 2 of appendix B to part 20; and
(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.
(c) Upon approval from the Commission, the licensee may adjust the effluent concentration values in appendix B to part 20, table 2, for members of the public, to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium, chemical form).
(a) The criteria in this subpart apply to the decommissioning of facilities licensed under parts 30, 40, 50, 60, 61, 63, 70, and 72 of this chapter, as well as other facilities subject to the Commission's jurisdiction under the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended. For high-level and low-level waste disposal facilities (10 CFR parts 60, 61, and 63), the criteria apply only to ancillary surface facilities that support radioactive waste disposal activities. The criteria do not apply to uranium and thorium recovery facilities already subject to Appendix A to 10 CFR part 40 or to uranium solution extraction facilities.
(b) The criteria in this subpart do not apply to sites which:
(1) Have been decommissioned prior to the effective date of the rule in accordance with criteria identified in the Site Decommissioning Management Plan (SDMP) Action Plan of April 16, 1992 (57 FR 13389);
(2) Have previously submitted and received Commission approval on a license termination plan (LTP) or decommissioning plan that is compatible with the SDMP Action Plan criteria; or
(3) Submit a sufficient LTP or decommissioning plan before August 20, 1998 and such LTP or decommissioning plan is approved by the Commission before August 20, 1999 and in accordance with the criteria identified in the SDMP Action Plan, except that if an EIS is required in the submittal, there will be a provision for day-for-day extension.
(c) After a site has been decommissioned and the license terminated in accordance with the criteria in this subpart, the Commission will require additional cleanup only if based on new information, it determines that the criteria of this subpart were not met and residual activity remaining at the site could result in significant threat to public health and safety.
(d) When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first 1000 years after decommissioning.
A site will be considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 25 mrem (0.25 mSv) per year, including that from groundwater sources of drinking water, and that the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.
A site will be considered acceptable for license termination under restricted conditions if:
(a) The licensee can demonstrate that further reductions in residual radioactivity necessary to comply with the provisions of § 20.1402 would result in net public or environmental harm or were not being made because the residual levels associated with restricted conditions are ALARA. Determination of the levels which are ALARA must take into account consideration of any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal;
(b) The licensee has made provisions for legally enforceable institutional controls that provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) per year;
(c) The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. Acceptable financial assurance mechanisms are—
(1) Funds placed into an account segregated from the licensee's assets and outside the licensee's administrative control as described in § 30.35(f)(1) of this chapter;
(2) Surety method, insurance, or other guarantee method as described in § 30.35(f)(2) of this chapter;
(3) A statement of intent in the case of Federal, State, or local Government licensees, as described in § 30.35(f)(4) of this chapter; or
(4) When a government entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity.
(d) The licensee has submitted a decommissioning plan or License Termination Plan (LTP) to the Commission indicating the licensee's intent to decommission in accordance with §§ 30.36(d), 40.42(d), 50.82 (a) and (b), 70.38(d), or 72.54 of this chapter, and specifying that the licensee intends to decommission by restricting use of the site. The licensee shall document in the LTP or decommissioning plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice.
(1) Licensees proposing to decommission by restricting use of the site shall seek advice from such affected parties regarding the following matters concerning the proposed decommissioning—
(i) Whether provisions for institutional controls proposed by the licensee:
(A) Will provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) TEDE per year;
(B) Will be enforceable; and
(C) Will not impose undue burdens on the local community or other affected parties.
(ii) Whether the licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site;
(2) In seeking advice on the issues identified in § 20.1403(d)(1), the licensee shall provide for:
(i)Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;
(ii) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and
(iii) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement or disagreement among the participants on the issues; and
(e) Residual radioactivity at the site has been reduced so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is as low as reasonably achievable and would not exceed either—
(1) 100 mrem (1 mSv) per year; or
(2) 500 mrem (5 mSv) per year provided that the licensee—
(i) Demonstrates that further reductions in residual radioactivity necessary to comply with the 100 mrem/y (1 mSv/y) value of paragraph (e)(1) of this section are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm;
(ii) Makes provisions for durable institutional controls;
(iii) Provides sufficient financial assurance to enable a responsible government entity or independent third party, including a governmental custodian of a site, both to carry out periodic rechecks of the site no less frequently than every 5 years to assure that the institutional controls remain in place as necessary to meet the criteria of § 20.1403(b) and to assume and carry out responsibilities for any necessary control and maintenance of those controls. Acceptable financial assurance mechanisms are those in paragraph (c) of this section.
(a) The Commission may terminate a license using alternate criteria greater than the dose criterion of §§ 20.1402, 20.1403(b), and 20.1403(d)(1)(i)(A), if the licensee—
(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the 1 mSv/y (100 mrem/y) limit of subpart D, by submitting an analysis of possible sources of exposure;
(2) Has employed to the extent practical restrictions on site use according to the provisions of § 20.1403 in minimizing exposures at the site; and
(3) Reduces doses to ALARA levels, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste disposal.
(4) Has submitted a decommissioning plan or License Termination Plan (LTP) to the Commission indicating the licensee's intent to decommission in accordance with §§ 30.36(d), 40.42(d), 50.82 (a) and (b), 70.38(d), or 72.54 of this chapter, and specifying that the licensee proposes to decommission by use of alternate criteria. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the
(i) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;
(ii) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and
(iii) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement on the issues.
(b) The use of alternate criteria to terminate a license requires the approval of the Commission after consideration of the NRC staff's recommendations that will address any comments provided by the Environmental Protection Agency and any public comments submitted pursuant to § 20.1405.
Upon the receipt of an LTP or decommissioning plan from the licensee, or a proposal by the licensee for release of a site pursuant to §§ 20.1403 or 20.1404, or whenever the Commission deems such notice to be in the public interest, the Commission shall:
(a) Notify and solicit comments from:
(1) Local and State governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and
(2) The Environmental Protection Agency for cases where the licensee proposes to release a site pursuant to § 20.1404.
(b) Publish a notice in the
Applicants for licenses, other than renewals, after August 20, 1997, shall describe in the application how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste.
(a) Each licensee shall make or cause to be made, surveys that—
(1) May be necessary for the licensee to comply with the regulations in this part; and
(2) Are reasonable under the circumstances to evaluate—
(i) The magnitude and extent of radiation levels; and
(ii) Concentrations or quantities of radioactive material; and
(iii) The potential radiological hazards.
(b) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.
(c) All personnel dosimeters (except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities) that require processing to determine the radiation dose and that are used by licensees to comply with § 20.1201, with other applicable provisions of this chapter, or with conditions specified in a license must be processed and evaluated by a dosimetry processor—
(1) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and
(2) Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
Each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum—
(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by—
(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),
(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);
(4) Individuals entering a high or very high radiation area.
(b) Each licensee shall monitor (see § 20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to—
(1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, columns 1 and 2, of appendix B to §§ 20.1001-20.2402;
(2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and
(3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).
(a) The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features—
(1) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep-dose equivalent of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates;
(2) A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or
(3) Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.
(b) In place of the controls required by paragraph (a) of this section for a high radiation area, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
(c) A licensee may apply to the Commission for approval of alternative methods for controlling access to high radiation areas.
(d) The licensee shall establish the controls required by paragraphs (a) and (c) of this section in a way that does not prevent individuals from leaving a high radiation area.
(e) Control is not required for each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the Department of Transportation provided that—
(1) The packages do not remain in the area longer than 3 days; and
(2) The dose rate at 1 meter from the external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour.
(f) Control of entrance or access to rooms or other areas in hospitals is not required solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who will take the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the limits established in this part and to operate within the ALARA provisions of the licensee's radiation protection program.
In addition to the requirements in § 20.1601, the licensee shall institute additional measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 grays) or more in 1 hour at 1 meter from a radiation source or any surface through which the radiation penetrates.
The licensee shall use, to the extent practical, process or other engineering controls (
(a) When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means—
(1) Control of access;
(2) Limitation of exposure times;
(3) Use of respiratory protection equipment; or
(4) Other controls.
(b) If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee should also consider the impact of respirator use on workers’ industrial health and safety.
If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material,
(a) The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this part.
(b) If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the NRC for authorized use of this equipment except as provided in this part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information.
(c) The licensee shall implement and maintain a respiratory protection program that includes:
(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;
(2) Surveys and bioassays, as necessary, to evaluate actual intakes;
(3) Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use;
(4) Written procedures regarding—
(i) Monitoring, including air sampling and bioassays;
(ii) Supervision and training of respirator users;
(iii) Fit testing;
(iv) Respirator selection;
(v) Breathing air quality;
(vi) Inventory and control;
(vii) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;
(viii) Recordkeeping; and
(ix) Limitations on periods of respirator use and relief from respirator use;
(5) Determination by a physician that the individual user is medically fit to use respiratory protection equipment:
(i) Before the initial fitting of a face sealing respirator;
(ii) Before the first field use of non-face sealing respirators, and
(iii) Either every 12 months thereafter, or periodically at a frequency determined by a physician.
(6) Fit testing, with fit factor ≥ 10 times the APF for negative pressure devices, and a fit factor ≥ 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode.
(d) The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.
(e) The licensee shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.
(f) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.
(g) Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, “Commodity Specification for Air,” 1997 and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E)). Grade D quality air criteria include—
(1) Oxygen content (v/v) of 19.5-23.5%;
(2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;
(3) Carbon monoxide (CO) content of 10 ppm or less;
(4) Carbon dioxide content of 1,000 ppm or less; and
(5) Lack of noticeable odor.
(h) The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face—facepiece seal or valve function, and that are under
(i) In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.
The Commission may impose restrictions in addition to the provisions of §§ 20.1702, 20.1703, and Appendix A to Part 20, in order to:
(a) Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and
(b) Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.
The licensee shall obtain authorization from the Commission before using assigned protection factors in excess of those specified in Appendix A to part 20. The Commission may authorize a licensee to use higher assigned protection factors on receipt of an application that—
(a) Describes the situation for which a need exists for higher protection factors; and
(b) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.
The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
(a)
(1) Cross-hatched area is to be magenta, or purple, or black, and
(2) The background is to be yellow.
(b)
(c)
(a)
(b)
(c)
(d)
(e)
(a) A licensee is not required to post caution signs in areas or rooms containing radioactive materials for periods of less than 8 hours, if each of the following conditions is met:
(1) The materials are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation or radioactive materials in excess of the limits established in this part; and
(2) The area or room is subject to the licensee's control.
(b) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to § 20.1902 provided that the patient could be released from licensee control pursuant to § 35.75 of this chapter.
(c) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at 30 centimeters from the surface of the source container or housing does not exceed 0.005 rem (0.05 mSv) per hour.
(d) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs under § 20.1902 if—
(1) Access to the room is controlled pursuant to 10 CFR 35.615; and
(2) Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this part.
(a) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL.” The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.
(b) Each licensee shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.
A licensee is not required to label—
(a) Containers holding licensed material in quantities less than the quantities listed in appendix C to part 20; or
(b) Containers holding licensed material in concentrations less than those specified in table 3 of appendix B to part 20; or
(c) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by this part; or
(d) Containers when they are in transport and packaged and labeled in
(e) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record (examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells). The record must be retained as long as the containers are in use for the purpose indicated on the record; or
(f) Installed manufacturing or process equipment, such as reactor components, piping, and tanks.
(a) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in § 71.4 and appendix A to part 71 of this chapter, shall make arrangements to receive—
(1) The package when the carrier offers it for delivery; or
(2) Notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
(b) Each licensee shall—
(1) Monitor the external surfaces of a labeled
(2) Monitor the external surfaces of a labeled
(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
(c) The licensee shall perform the monitoring required by paragraph (b) of this section as soon as practical after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours.
(d) The licensee shall immediately notify the final delivery carrier and the NRC Operations Center (301-816-5100), by telephone, when—
(1) Removable radioactive surface contamination exceeds the limits of § 71.87(i) of this chapter; or
(2) External radiation levels exceed the limits of § 71.47 of this chapter.
(e) Each licensee shall—
(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and
(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.
(f) Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of paragraph (b) of this section, but are not exempt from the survey requirement in paragraph (b) of this section for measuring radiation levels that is required to ensure that the source is still properly lodged in its shield.
(a) A licensee shall dispose of licensed material only—
(1) By transfer to an authorized recipient as provided in § 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of this chapter;
(2) By decay in storage; or
(3) By release in effluents within the limits in § 20.1301; or
(4) As authorized under §§ 20.2002, 20.2003, 20.2004, or § 20.2005.
(b) A person must be specifically licensed to receive waste containing licensed material from other persons for:
(1) Treatment prior to disposal; or
(2) Treatment or disposal by incineration; or
(3) Decay in storage; or
(4) Disposal at a land disposal facility licensed under part 61 of this chapter; or
(5) Disposal at a geologic repository under part 60 or part 63 of this chapter.
A licensee or applicant for a license may apply to the Commission for approval of proposed procedures, not otherwise authorized in the regulations in this chapter, to dispose of licensed material generated in the licensee's activities. Each application shall include:
(a) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties important to risk evaluation, and the proposed manner and conditions of waste disposal; and
(b) An analysis and evaluation of pertinent information on the nature of the environment; and
(c) The nature and location of other potentially affected licensed and unlicensed facilities; and
(d) Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in this part.
(a) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:
(1) The material is readily soluble (or is readily dispersible biological material) in water; and
(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table 3 of appendix B to part 20; and
(3) If more than one radionuclide is released, the following conditions must also be satisfied:
(i) The licensee shall determine the fraction of the limit in table 3 of appendix B to part 20 represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table 3 of appendix B to part 20; and
(ii) The sum of the fractions for each radionuclide required by paragraph (a)(3)(i) of this section does not exceed unity; and
(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials combined.
(b) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (a) of this section.
(a) A licensee may treat or dispose of licensed material by incineration only:
(1) As authorized by paragraph (b) of this section; or
(2) If the material is in a form and concentration specified in § 20.2005; or
(3) As specifically approved by the Commission pursuant to § 20.2002.
(b)(1) Waste oils (petroleum derived or synthetic oils used principally as lubricants, coolants, hydraulic or insulating fluids, or metalworking oils)
(2) Solid residues produced in the process of incinerating waste oils must be disposed of as provided by § 20.2001.
(3) The provisions of this section authorize onsite waste oil incineration under the terms of this section and supersede any provision in an individual plant license or technical specification that may be inconsistent.
(a) A licensee may dispose of the following licensed material as if it were not radioactive:
(1) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; and
(2) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal.
(b) A licensee may not dispose of tissue under paragraph (a)(2) of this section in a manner that would permit its use either as food for humans or as animal feed.
(c) The licensee shall maintain records in accordance with § 20.2108.
(a) The requirements of this section and appendix G to 10 CFR part 20 are designed to—
(1) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee, as defined in this part, who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level waste land disposal facility (as defined in part 61 of this chapter);
(2) Establish a manifest tracking system; and
(3) Supplement existing requirements concerning transfers and recordkeeping for those wastes.
(b) Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility must document the information required on NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with appendix G to 10 CFR part 20.
(c) Each shipment manifest must include a certification by the waste generator as specified in section II of appendix G to 10 CFR part 20.
(d) Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in section III of appendix G to 10 CFR part 20.
Nothing in this subpart relieves the licensee from complying with other applicable Federal, State, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this subpart.
(a) Each licensee shall use the units: curie, rad, rem, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this part.
(b) In the records required by this part, the licensee may record quantities in SI units in parentheses following each of the units specified in paragraph (a) of this section. However, all quantities must be recorded as stated in paragraph (a) of this section.
(c) Not withstanding the requirements of paragraph (a) of this section, when recording information on shipment manifests, as required in § 20.2006(b), information must be recorded in the International System of Units (SI) or in SI and units as specified in paragraph (a) of this section.
(d) The licensee shall make a clear distinction among the quantities entered on the records required by this part (e.g., total effective dose equivalent, shallow-dose equivalent, lens dose equivalent, deep-dose equivalent, committed effective dose equivalent).
(a) Each licensee shall maintain records of the radiation protection program, including:
(1) The provisions of the program; and
(2) Audits and other reviews of program content and implementation.
(b) The licensee shall retain the records required by paragraph (a)(1) of this section until the Commission terminates each pertinent license requiring the record. The licensee shall retain the records required by paragraph (a)(2) of this section for 3 years after the record is made.
(a) Each licensee shall maintain records showing the results of surveys and calibrations required by §§ 20.1501 and 20.1906(b). The licensee shall retain these records for 3 years after the record is made.
(b) The licensee shall retain each of the following records until the Commission terminates each pertinent license requiring the record:
(1) Records of the results of surveys to determine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents. This includes those records of results of surveys to determine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents required under the standards for protection against radiation in effect prior to January 1, 1994; and
(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose. This includes those records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose required under the standards for protection against radiation in effect prior to January 1, 1994; and
(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to § 20.1703(c)(1) and (2). This includes those records showing the results of air sampling, surveys, and bioassays required under the standards for protection against radiation in effect prior to January 1, 1994; and
(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment. This includes those records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment required under the standards for protection against radiation in effect prior to January 1, 1994.
(a) For each individual who is likely to receive in a year, an occupational dose requiring monitoring pursuant to § 20.1502 the licensee shall—
(1) Determine the occupational radiation dose received during the current year; and
(2) Attempt to obtain the records of cumulative occupational radiation dose.
(b) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine—
(1) The internal and external doses from all previous planned special exposures; and
(2) All doses in excess of the limits (including doses received during accidents and emergencies) received during the lifetime of the individual.
(c) In complying with the requirements of paragraph (a) of this section, a licensee may—
(1) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;
(2) Accept, as the record of cumulative radiation dose, an up-to-date NRC Form 4, or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee); and
(3) Obtain reports of the individual's dose equivalent(s) from the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee) by telephone, telegram, electronic media, or letter. The licensee shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.
(d) The licensee shall record the exposure history of each individual, as required by paragraph (a) of this section, on NRC Form 4, or other clear and legible record, including all of the information required by NRC Form 4
(e) If the licensee is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee shall assume—
(1) In establishing administrative controls under § 20.1201(f) for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and
(2) That the individual is not available for planned special exposures.
(f) The licensee shall retain the records on NRC Form 4 or equivalent until the Commission terminates each pertinent license requiring this record. The licensee shall retain records used in preparing NRC Form 4 for 3 years after the record is made. This includes records required under the standards for protection against radiation in effect prior to January 1, 1994.
(a) For each use of the provisions of § 20.1206 for planned special exposures, the licensee shall maintain records that describe—
(1) The exceptional circumstances requiring the use of a planned special exposure; and
(2) The name of the management official who authorized the planned special exposure and a copy of the signed authorization; and
(3) What actions were necessary; and
(4) Why the actions were necessary; and
(5) How doses were maintained ALARA; and
(6) What individual and collective doses were expected to result, and the doses actually received in the planned special exposure.
(b) The licensee shall retain the records until the Commission terminates each pertinent license requiring these records.
(a)
(1) The deep-dose equivalent to the whole body, lens dose equivalent, shallow-dose equivalent to the skin, and shallow-dose equivalent to the extremities;
(2) The estimated intake of radionuclides (see § 20.1202);
(3) The committed effective dose equivalent assigned to the intake of radionuclides;
(4) The specific information used to assess the committed effective dose equivalent pursuant to § 20.1204 (a) and (c), and when required by § 20.1502;
(5) The total effective dose equivalent when required by § 20.1202; and
(6) The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose.
(b)
(c)
(d)
(e) The licensee shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records.
(f) The licensee shall retain the required form or record until the Commission terminates each pertinent license requiring this record. This includes records required under the standards for protection against radiation in effect prior to January 1, 1994.
(a) Each licensee shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public (see § 20.1301).
(b) The licensee shall retain the records required by paragraph (a) of this section until the Commission terminates each pertinent license requiring the record.
(a) Each licensee shall maintain records of the disposal of licensed materials made under §§ 20.2002, 20.2003, 20.2004, 20.2005, 10 CFR part 61 and disposal by burial in soil, including burials authorized before January 28, 1981.
(b) The licensee shall retain the records required by paragraph (a) of
Each record required by this part must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a)
(i) Immediately after its occurrence becomes known to the licensee, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in appendix C to part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas; or
(ii) Within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in appendix C to part 20 that is still missing at this time.
(2) Reports must be made as follows:
(i) Licensees having an installed Emergency Notification System shall make the reports to the NRC Operations Center in accordance with § 50.72 of this chapter, and
(ii) All other licensees shall make reports by telephone to the NRC Operations Center (301-816-5100).
(b)
(i) A description of the licensed material involved, including kind, quantity, and chemical and physical form; and
(ii) A description of the circumstances under which the loss or theft occurred; and
(iii) A statement of disposition, or probable disposition, of the licensed material involved; and
(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas; and
(v) Actions that have been taken, or will be taken, to recover the material; and
(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.
(2) Reports must be made as follows:
(i) For holders of an operating license for a nuclear power plant, the events included in paragraph (b) of this section must be reported in accordance with the procedures described in § 50.73(b), (c), (d), (e), and (g) of this chapter and must include the information required in paragraph (b)(1) of this section, and
(ii) All other licensees shall make reports to the Administrator of the appropriate NRC Regional Office listed in appendix D to part 20.
(c) A duplicate report is not required under paragraph (b) of this section if the licensee is also required to submit a report pursuant to §§ 30.55(c), 40.64(c),
(d) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.
(e) The licensee shall prepare any report filed with the Commission pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable part of the report.
(a) Immediate notification. Notwithstanding any other requirements for notification, each licensee shall immediately report any event involving byproduct, source, or special nuclear material possessed by the licensee that may have caused or threatens to cause any of the following conditions—
(1) An individual to receive—
(i) A total effective dose equivalent of 25 rems (0.25 Sv) or more; or
(ii) A lens dose equivalent of 75 rems (0.75 Sv) or more; or
(iii) A shallow-dose equivalent to the skin or extremities of 250 rads (2.5 Gy) or more; or
(2) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the annual limit on intake (the provisions of this paragraph do not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures).
(b) Twenty-four hour notification. Each licensee shall, within 24 hours of discovery of the event, report any event involving loss of control of licensed material possessed by the licensee that may have caused, or threatens to cause, any of the following conditions:
(1) An individual to receive, in a period of 24 hours—
(i) A total effective dose equivalent exceeding 5 rems (0.05 Sv); or
(ii) A lens dose equivalent exceeding 15 rems (0.15 Sv); or
(iii) A shallow-dose equivalent to the skin or extremities exceeding 50 rems (0.5 Sv); or
(2) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational annual limit on intake (the provisions of this paragraph do not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures).
(c) The licensee shall prepare any report filed with the Commission pursuant to this section so that names of individuals who have received exposure to radiation or radioactive material are stated in a separate and detachable part of the report.
(d) Reports made by licensees in response to the requirements of this section must be made as follows:
(1) Licensees having an installed Emergency Notification System shall make the reports required by paragraphs (a) and (b) of this section to the NRC Operations Center in accordance with 10 CFR 50.72; and
(2) All other licensees shall make the reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operations Center (301) 816-5100.
(e) The provisions of this section do not include doses that result from planned special exposures, that are within the limits for planned special exposures, and that are reported under § 20.2204.
(a)
(1) Any incident for which notification is required by § 20.2202; or
(2) Doses in excess of any of the following:
(i) The occupational dose limits for adults in § 20.1201; or
(ii) The occupational dose limits for a minor in § 20.1207; or
(iii) The limits for an embryo/fetus of a declared pregnant woman in § 20.1208; or
(iv) The limits for an individual member of the public in § 20.1301; or
(v) Any applicable limit in the license; or
(vi) The ALARA constraints for air emissions established under § 20.1101(d); or
(3) Levels of radiation or concentrations of radioactive material in—
(i) A restricted area in excess of any applicable limit in the license; or
(ii) An unrestricted area in excess of 10 times any applicable limit set forth in this part or in the license (whether or not involving exposure of any individual in excess of the limits in § 20.1301); or
(4) For licensees subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.
(b)
(i) Estimates of each individual's dose; and
(ii) The levels of radiation and concentrations of radioactive material involved; and
(iii) The cause of the elevated exposures, dose rates, or concentrations; and
(iv) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license conditions.
(2) Each report filed pursuant to paragraph (a) of this section must include for each occupationally overexposed
(c) For holders of an operating license for a nuclear power plant, the occurrences included in paragraph (a) of this section must be reported in accordance with the procedures described in § 50.73(b), (c), (d), (e), and (g) of this chapter and must also include the information required by paragraph (b) of this section. Occurrences reported in accordance with § 50.73 of this chapter need not be reported by a duplicate report under paragraph (a) of this section.
(d) All licensees, other than those holding an operating license for a nuclear power plant, who make reports under paragraph (a) of this section shall submit the report in writing to the U.S. Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555, with a copy to the appropriate NRC Regional Office listed in appendix D to part 20.
The licensee shall submit a written report to the Administrator of the appropriate NRC Regional Office listed in appendix D to part 20 within 30 days following any planned special exposure conducted in accordance with § 20.1206, informing the Commission that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by § 20.2105.
When a licensee is required, pursuant to the provisions of §§ 20.2203, 20.2204, or 20.2206, to report to the Commission
(a) This section applies to each person licensed by the Commission to—
(1) Operate a nuclear reactor designed to produce electrical or heat energy pursuant to § 50.21(b) or § 50.22 of this chapter or a testing facility as defined in § 50.2 of this chapter; or
(2) Possess or use byproduct material for purposes of radiography pursuant to parts 30 and 34 of this chapter; or
(3) Possess or use at any one time, for purposes of fuel processing, fabricating, or reprocessing, special nuclear material in a quantity exceeding 5,000 grams of contained uranium-235, uranium-233, or plutonium, or any combination thereof pursuant to part 70 of this chapter; or
(4) Possess high-level radioactive waste at a geologic repository operations area pursuant to part 60 or 63 of this chapter; or
(5) Possess spent fuel in an independent spent fuel storage installation (ISFSI) pursuant to part 72 of this chapter; or
(6) Receive radioactive waste from other persons for disposal under part 61 of this chapter; or
(7) Possess or use at any time, for processing or manufacturing for distribution pursuant to parts 30, 32, 33 or 35 of this chapter, byproduct material in quantities exceeding any one of the following quantitites:
(b) Each licensee in a category listed in paragraph (a) of this section shall submit an annual report of the results of individual monitoring carried out by the licensee for each individual for whom monitoring was required by § 20.1502 during that year. The licensee may include additional data for individuals for whom monitoring was provided but not required. The licensee shall use Form NRC 5 or electronic media containing all the information required by Form NRC 5.
(c) The licensee shall file the report required by § 20.2206(b), covering the preceding year, on or before April 30 of each year. The licensee shall submit the report to the REIRS Project Manager, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
The Commission may, upon application by a licensee or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it determines the exemption is authorized by law and would not result in undue hazard to life or property.
The Commission may, by rule, regulation, or order, impose requirements on a licensee, in addition to those established in the regulations in this part, as it deems appropriate or necessary to protect health or to minimize danger to life or property.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107 or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; and
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under Section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in §§ 20.1001 through 20.2402 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) this section.
(b) The regulations in §§ 20.1001 through 20.2402 that are not issued under Sections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 20.1001, 20.1002, 20.1003, 20.1004, 20.1005, 20.1006, 20.1007, 20.1008, 20.1009, 20.1405, 20.1704, 20.1903, 20.1905, 20.2002, 20.2007, 20.2301, 20.2302, 20.2401, and 20.2402.
For each radionuclide table 1 indicates the chemical form which is to be used for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 μm and for three classes (D,W,Y) of radioactive material, which refer to their retention (approximately days, weeks or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times of less than 10 days for D, for W from 10 to 100 days, and for Y greater than 100 days. The class (D, W, or Y) given in the column headed “Class” applies only to the inhalation ALIs and DACs given in table 1, columns 2 and 3. Table 2 provides concentration limits for airborne and liquid effluents released to the general environment. Table 3 provides concentration limits for discharges to sanitary sewer systems.
The values in tables 1, 2, and 3 are presented in the computer “E” notation. In this notation a value of 6E−02 represents a value of 6×10
Note that the columns in table 1, of this appendix captioned “Oral Ingestion ALI,” “Inhalation ALI,” and “DAC,” are applicable to occupational exposure to radioactive material.
The ALIs in this appendix are the annual intakes of a given radionuclide by “Reference Man” which would result in either (1) a committed effective dose equivalent of 5 rems (stochastic ALI) or (2) a committed dose equivalent of 50 rems to an organ or tissue (non-stochastic ALI). The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 5 rems. The derivation includes multiplying the committed dose equivalent to an organ or tissue by a
A value of w
Note that the dose equivalents for extremities (hands and forearms, feet and lower legs), skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately.
When an ALI is defined by the stochastic dose limit, this value alone, is given. When an ALI is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. (Abbreviated organ or tissue designations are used: LLI wall = lower large intestine wall; St. wall = stomach wall; Blad wall = bladder wall; and Bone surf = bone surface.)
The use of the ALIs listed first, the more limiting of the stochastic and non-stochastic ALIs, will ensure that non-stochastic effects are avoided and that the risk of stochastic effects is limited to an acceptably low value. If, in a particular situation involving a radionuclide for which the non-stochastic ALI is limiting, use of that non-stochastic ALI is considered unduly conservative, the licensee may use the stochastic ALI to determine the committed effective dose equivalent. However, the licensee shall also ensure that the 50-rem dose equivalent limit for any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the internal committed dose to that organ (not the effective dose). For the case where there is no external dose contribution, this would be demonstrated if the sum of the fractions of the nonstochastic ALIs (ALI
The derived air concentration (DAC) values are derived limits intended to control chronic occupational exposures. The relationship between the DAC and the ALI is given by: DAC=ALI(in μCi)/(2000 hours per working year×60 minutes/hour×2×10
The DAC values relate to one of two modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. Derived air concentrations based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately.
The ALI and DAC values relate to exposure to the single radionuclide named, but also include contributions from the in-growth of any daughter radionuclide produced in the body by the decay of the parent. However, intakes that include both the parent and daughter radionuclides should be treated by the general method appropriate for mixtures.
The value of ALI and DAC do not apply directly when the individual both ingests and inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external radiation (see § 20.1202). When an individual is exposed to radioactive materials which fall under several of the translocation classifications (i.e., Class D, Class W, or Class Y) of the same radionuclide, the exposure may be evaluated as if it were a mixture of different radionuclides.
It should be noted that the classification of a compound as Class D, W, or Y is based on the chemical form of the compound and does not take into account the radiological half-life of different radioisotopes. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionuclides.
The columns in table 2 of this appendix captioned “Effluents,” “Air,” and “Water,” are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of § 20.1302. The concentration values given in columns 1 and 2 of table 2 are equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the course of a year, would produce a total effective dose equivalent of 0.05 rem (50 millirem or 0.5 millisieverts).
Consideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at the dose levels established for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was used in deriving the
The air concentration values listed in table 2, column 1, were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by 2.4×10
For those radionuclides for which submersion (external dose) is limiting, the occupational DAC in table 1, column 3, was divided by 219. The factor of 219 is composed of a factor of 50, as described above, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full-time exposure (8,760 hours per year). Note that an additional factor of 2 for age considerations is not warranted in the submersion case.
The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3×10
Note 2 of this appendix provides groupings of radionuclides which are applicable to unknown mixtures of radionuclides. These groupings (including occupational inhalation ALIs and DACs, air and water effluent concentrations and sewerage) require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded either from knowledge of the radionuclide composition of the source or from actual measurements.
The monthly average concentrations for release to sanitary sewers are applicable to the provisions in § 20.2003. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3×10
A waste generator, collector, or processor who transports, or offers for transportation, low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste land disposal facility must prepare a Manifest (OMB Control Numbers 3150-0164, -0165, and -0166) reflecting information requested on applicable NRC Forms 540 (Uniform Low-Level Radioactive Waste Manifest (Shipping Paper)) and 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description)) and, if necessary, on an applicable NRC Form 542 (Uniform Low-Level Radioactive Waste Manifest (Manifest Index and Regional Compact Tabulation)). NRC Forms 540 and 540A must be completed and must physically accompany the pertinent low-level waste shipment. Upon agreement between shipper and consignee, NRC Forms 541 and 541A and 542 and 542A may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete records on the respective forms. Licensees are not required by NRC to comply with the manifesting requirements of this part when they ship:
(a) LLW for processing and expect its return (i.e., for storage under their license) prior to disposal at a licensed land disposal facility;
(b) LLW that is being returned to the licensee who is the “waste generator” or “generator,” as defined in this part; or
(c) Radioactively contaminated material to a “waste processor” that becomes the processor's “residual waste.”
For guidance in completing these forms, refer to the instructions that accompany the forms. Copies of manifests required by this appendix may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform manifest.
NRC Forms 540, 540A, 541, 541A, 542 and 542A, and the accompanying instructions, in hard copy, may be obtained from the Information and Records Management Branch, Office of Information Resources Management, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-7232.
This appendix includes information requirements of the Department of Transportation, as codified in 49 CFR part 172. Information on hazardous, medical, or other waste, required to meet Environmental Protection Agency regulations, as codified in 40 CFR parts 259, 261 or elsewhere, is not addressed in this section, and must be provided on the required EPA forms. However, the required EPA forms must accompany the Uniform Low-Level Radioactive Waste Manifest required by this chapter.
As used in this appendix, the following definitions apply:
The shipper of the radioactive waste, shall provide the following information on the uniform manifest:
1. The name, facility address, and telephone number of the licensee shipping the waste;
2. An explicit declaration indicating whether the shipper is acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and
3. The name, address, and telephone number, or the name and EPA identification number for the carrier transporting the waste.
The shipper of the radioactive waste shall provide the following information regarding the waste shipment on the uniform manifest:
1. The date of the waste shipment;
2. The total number of packages/disposal containers;
3. The total disposal volume and disposal weight in the shipment;
4. The total radionuclide activity in the shipment;
5. The activity of each of the radionuclides H-3, C-14, Tc-99, and I-129 contained in the shipment; and
6. The total masses of U-233, U-235, and plutonium in special nuclear material, and the total mass of uranium and thorium in source material.
The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding the waste and each disposal container of waste in the shipment:
1. An alphabetic or numeric identification that uniquely identifies each disposal container in the shipment;
2. A physical description of the disposal container, including the manufacturer and model of any high integrity container;
3. The volume displaced by the disposal container;
4. The gross weight of the disposal container, including the waste;
5. For waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;
6. A physical and chemical description of the waste;
7. The total weight percentage of chelating agent for any waste containing more than 0.1% chelating agent by weight, plus the identity of the principal chelating agent;
8. The approximate volume of waste within a container;
9. The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name;
10. The identities and activities of individual radionuclides contained in each container, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material. For discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides associated with or contained on these waste types within a disposal container shall be reported;
11. The total radioactivity within each container; and
12. For wastes consigned to a disposal facility, the classification of the waste pursuant to § 61.55 of this chapter. Waste not meeting the structural stability requirements of § 61.56(b) of this chapter must be identified.
The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding a waste shipment delivered without a disposal container:
1. The approximate volume and weight of the waste;
2. A physical and chemical description of the waste;
3. The total weight percentage of chelating agent if the chelating agent exceeds 0.1% by weight, plus the identity of the principal chelating agent;
4. For waste consigned to a disposal facility, the classification of the waste pursuant to § 61.55 of this chapter. Waste not meeting the structural stability requirements of § 61.56(b) of this chapter must be identified;
5. The identities and activities of individual radionuclides contained in the waste, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material; and
6. For wastes consigned to a disposal facility, the maximum radiation levels at the surface of the waste.
This section applies to disposal containers enclosing mixtures of waste originating from different generators. (Note: The origin of the LLW resulting from a processor's activities may be attributable to one or more “generators” (including “waste generators”) as defined in this part). It also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators.
1. For homogeneous mixtures of waste, such as incinerator ash, provide the waste description applicable to the mixture and the volume of the waste attributed to each generator.
2. For heterogeneous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each generator, provide the following:
(a) The volume of waste within the disposal container;
(b) A physical and chemical description of the waste, including the solidification agent, if any;
(c) The total weight percentage of chelating agents for any disposal container containing more than 0.1% chelating agent by weight, plus the identity of the principal chelating agent;
(d) The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in 10 CFR 61.56(b); and
(e) Radionuclide identities and activities contained in the waste, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material if contained in the waste.
An authorized representative of the waste generator, processor, or collector shall certify by signing and dating the shipment manifest that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the Department of Transportation and the Commission. A collector in signing the certification is certifying that nothing has been done to the collected waste which would invalidate the waste generator's certification.
A. Any licensee who transfers radioactive waste to a land disposal facility or a licensed waste collector shall comply with the requirements in paragraphs A.1 through 9 of this section. Any licensee who transfers waste to a licensed waste processor for waste treatment or repackaging shall comply with the requirements of paragraphs A.4 through 9 of this section. A licensee shall:
1. Prepare all wastes so that the waste is classified according to § 61.55 and meets the waste characteristics requirements in § 61.56 of this chapter;
2. Label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste to identify whether it is Class A waste, Class B waste, Class C waste, or greater then Class C waste, in accordance with § 61.55 of this chapter;
3. Conduct a quality assurance program to assure compliance with §§ 61.55 and 61.56 of this chapter (the program must include management evaluation of audits);
4. Prepare the NRC Uniform Low-Level Radioactive Waste Manifest as required by this appendix;
5. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either (i) receipt of the manifest precedes the LLW shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;
6. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in paragraph A.5 of this section;
7. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;
8. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter; and
9. For any shipments or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix.
B. Any waste collector licensee who handles only prepackaged waste shall:
1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540;
2. Prepare a new manifest to reflect consolidated shipments that meet the requirements of this appendix. The waste collector shall ensure that, for each container of waste in the shipment, the manifest identifies the generator of that container of waste;
3. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either: (i) Receipt of the manifest precedes the LLW shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;
4. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in paragraph B.3 of this section;
5. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;
6. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter;
7. For any shipments or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix; and
8. Notify the shipper and the Administrator of the nearest Commission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.
C. Any licensed waste processor who treats or repackages waste shall:
1. Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540;
2. Prepare a new manifest that meets the requirements of this appendix. Preparation of the new manifest reflects that the processor is responsible for meeting these requirements. For each container of waste in the shipment, the manifest shall identify the waste generators, the preprocessed waste volume, and the other information as required in paragraph I.E. of this appendix;
3. Prepare all wastes so that the waste is classified according to § 61.55 of this chapter and meets the waste characteristics requirements in § 61.56 of this chapter;
4. Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with §§ 61.55 and 61.57 of this chapter;
5. Conduct a quality assurance program to assure compliance with §§ 61.55 and 61.56 of this chapter (the program shall include management evaluation of audits);
6. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so
7. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in paragraph C.6 of this section;
8. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;
9. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by 10 CFR parts 30, 40, and 70 of this chapter;
10. For any shipment or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with paragraph E of this appendix; and
11. Notify the shipper and the Administrator of the nearest Commission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.
D. The land disposal facility operator shall:
1. Acknowledge receipt of the waste within one week of receipt by returning, as a minimum, a signed copy of NRC Form 540 to the shipper. The shipper to be notified is the licensee who last possessed the waste and transferred the waste to the operator. If any discrepancy exists between materials listed on the Uniform Low-Level Radioactive Waste Manifest and materials received, copies or electronic transfer of the affected forms must be returned indicating the discrepancy;
2. Maintain copies of all completed manifests and electronically store the information required by 10 CFR 61.80(l) until the Commission terminates the license; and
3. Notify the shipper and the Administrator of the nearest Commission Regional Office listed in appendix D of this part when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.
E. Any shipment or part of a shipment for which acknowledgement is not received within the times set forth in this section must:
1. Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and
2. Be traced and reported. The investigation shall include tracing the shipment and filing a report with the nearest Commission Regional Office listed in appendix D to this part. Each licensee who conducts a trace investigation shall file a written report with the appropriate NRC Regional Office within 2 weeks of completion of the investigation.
Sec. 161, 68 Stat. 948, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2953 (42 U.S.C. 2201, 2282, 2297f); secs. 201, as amended, 206, 88 Stat. 1242, as amended, 1246 (42 U.S.C. 5841, 5846).
Section 21.2 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
The regulations in this part establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. That section requires any individual director or responsible officer of a firm constructing, owning, operating or supplying the components of any facility
(a) The regulations in this part apply, except as specifically provided otherwise in parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or part 72 of this chapter, to each individual, partnership, corporation, or other entity licensed pursuant to the regulations in this chapter to possess, use, or transfer within the United States source material, byproduct material, special nuclear material, and/or spent fuel and high-level radioactive waste, or to construct, manufacture, possess, own, operate, or transfer within the United States, any production or utilization facility or independent spent fuel storage installation (ISFSI) or monitored retrievable storage installation (MRS); and to each director and responsible officer of such a licensee. The regulations in this part apply also to each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such organization, that constructs a production or utilization facility licensed for the manufacture, construction, or operation pursuant to part 50 of this chapter, an ISFSI for the storage of spent fuel licensed pursuant to part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste pursuant to part 72 of this chapter, or a geologic repository for the disposal of high-level radioactive waste under part 60 or 63 of this chapter; or supplies basic components for a facility or activity licensed, other than for export, under parts 30, 40, 50, 60, 61, 63, 70, 71, or part 72 of this chapter.
(b) For persons licensed to construct a facility under a construction permit issued under § 50.23 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under § 50.55(e) of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974.
(c) For persons licensed to operate a nuclear power plant under part 50 of this chapter, evaluation of potential defects and appropriate reporting of defects under §§ 50.72, 50.73 or § 73.71 of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974.
(d) Nothing in these regulations should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item (as defined in § 21.3) not subject to the regulations in this part from reporting to the Commission, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. NRC regional offices and headquarters will accept collect telephone calls from individuals who wish to speak to NRC representatives concerning nuclear safety-related problems. The location and telephone numbers of the four regions (answered during regular working hours), are listed in appendix D to part 20 of this chapter. The telephone number of the NRC Operations Center (answered 24 hours a day—including holidays) is (301) 816-5100.
(e) The regulations in this part apply in accordance with 10 CFR 76.60 to each
As used in this part:
(A) The integrity of the reactor coolant pressure boundary;
(B) The capability to shut down the reactor and maintain it in a safe shutdown condition; or
(C) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to those referred to in § 50.34(a)(1), § 50.67(b)(2), or § 100.11 of this chapter, as applicable.
(ii) Basic components are items designed and manufactured under a quality assurance program complying with 10 CFR part 50, appendix B, or commercial grade items which have successfully completed the dedication process.
(2) When applied to other facilities and when applied to other activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic component means a structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee of a facility or activity subject to the regulations in this part and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the Commission could create a substantial safety hazard.
(3) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.
(2) When applied to facilities and activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, commercial grade item means an item that is:
(i) Not subject to design or specification requirements that are unique to those facilities or activities;
(ii) Used in applications other than those facilities or activities; and
(iii) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog).
(2) When applied to facilities and activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, dedication occurs after receipt when that item is designated for use as a basic component.
(1) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to the regulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or
(2) The installation, use, or operation of a basic component containing a defect as defined in this section; or
(3) A deviation in a portion of a facility subject to the construction permit or manufacturing licensing requirements of part 50 of this chapter provided the deviation could, on the basis of an evaluation, create a substantial safety hazard and the portion of the facility containing the deviation has been offered to the purchaser for acceptance; or
(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued pursuant to part 50 of this chapter.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
Except where otherwise specified in this part, all written communications and reports concerning the regulations in this part must be addressed to the Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555. In the case of a licensee, a copy must also be sent to the appropriate Regional Administrator at the address specified in appendix D to part 20 of this chapter.
(a)(1) Each individual, partnership, corporation, dedicating entity, or other entity subject to the regulations in this part shall post current copies of—
(i) The regulations in this part;
(ii) Section 206 of the Energy Reorganization Act of 1974; and
(iii) Procedures adopted pursuant to the regulations in this part.
(2) These documents must be posted in a conspicuous position on any premises within the United States where the activities subject to this part are conducted.
(b) If posting of the regulations in this part or the procedures adopted pursuant to the regulations in this part is not practicable, the licensee or firm subject to the regulations in this part may, in addition to posting section 206, post a notice which describes the regulations/procedures, including the name of the individual to whom reports may be made, and states where they may be examined.
(c) The effective date of this section has been deferred until January 6, 1978.
The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this part to the extent that they supply commercial grade items.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0035.
(b) The approved information collection requirements contained in this part appear in §§ 21.7, 21.21 and 21.51.
(a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall adopt appropriate procedures to—
(1) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (a)(2) of this section, in all cases within 60 days of discovery, in order to identify a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, and
(2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the Commission through a director or responsible officer or designated person as discussed in § 21.21(d)(5). The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply.
(3) Ensure that a director or responsible officer subject to the regulations of this part is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in § 21.21(a)(1) or § 21.21(a)(2) if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity—
(i) Fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to a substantial safety hazard, or
(ii) Contains a defect.
(b) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply, pursuant to § 21.21(a).
(c) A dedicating entity is responsible for—
(1) Identifying and evaluating deviations and reporting defects and failures to comply associated with substantial safety hazards for dedicated items; and
(2) Maintaining auditable records for the dedication process.
(d)(1) A director or responsible officer subject to the regulations of this part or a person designated under § 21.21(d)(5) must notify the Commission when he or she obtains information reasonably indicating a failure to comply or a defect affecting—
(i) The construction or operation of a facility or an activity within the United States that is subject to the licensing requirements under parts 30, 40, 50, 60, 61, 63, 70, 71, or 72 of this chapter and that is within his or her organization's responsibility; or
(ii) A basic component that is within his or her organization's responsibility and is supplied for a facility or an activity within the United States that is subject to the licensing requirements under parts 30, 40, 50, 60, 61, 63, 70, 71, or 72 of this chapter.
(2) The notification to NRC of a failure to comply or of a defect under paragraph (d)(1) of this section and the evaluation of a failure to comply or a defect under paragraphs (a)(1) and (a)(2) of this section, are not required if the director or responsible officer has actual knowledge that the Commission has been notified in writing of the defect or the failure to comply.
(3) Notification required by paragraph (d)(1) of this section must be made as follows—
(i) Initial notification by facsimile, which is the preferred method of notification, to the NRC Operations Center at (301) 816-5151 or by telephone at (301) 816-5100 within two days following receipt of information by the director or
(ii) Written notification to the NRC at the address specified in § 21.5 within 30 days following receipt of information by the director or responsible corporate officer under paragraph (a)(3) of this section, on the identification of a defect or a failure to comply.
(4) The written report required by this paragraph shall include, but need not be limited to, the following information, to the extent known:
(i) Name and address of the individual or individuals informing the Commission.
(ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.
(iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.
(iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.
(v) The date on which the information of such defect or failure to comply was obtained.
(vi) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in this part.
(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
(viii) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.
(5) The director or responsible officer may authorize an individual to provide the notification required by this paragraph, provided that, this shall not relieve the director or responsible officer of his or her responsibility under this paragraph.
(e) Individuals subject to this part may be required by the Commission to supply additional information related to a defect or failure to comply. Commission action to obtain additional information may be based on reports of defects from other reporting entities.
Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall ensure that each procurement document for a facility, or a basic component issued by him, her or it on or after January 6, 1978, specifies, when applicable, that the provisions of 10 CFR part 21 apply.
Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall permit the Commission to inspect records, premises, activities, and basic components as necessary to accomplish the purposes of this part.
(a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall prepare and maintain records necessary to accomplish the purposes of this part, specifically—
(1) Retain evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation;
(2) Suppliers of basic components must retain any notifications sent to purchasers and affected licensees for a
(3) Suppliers of basic components must retain a record of the purchasers of basic components for 10 years after delivery of the basic component or service associated with a basic component.
(b) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall permit the Commission the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.
(a) Any director or responsible officer of an entity (including dedicating entity) that is not otherwise subject to the deliberate misconduct provisions of this chapter but is subject to the regulations in this part who knowingly and consciously fails to provide the notice required as by § 21.21 shall be subject to a civil penalty equal to the amount provided by section 234 of the Atomic Energy Act of 1954, as amended.
(b) Any NRC licensee subject to the regulations in this part who fails to provide the notice required by § 21.21 or otherwise fails to comply with the applicable requirements of this part shall be subject to a civil penalty as provided by section 234 of the Atomic Energy Act of 1954, as amended.
(c) The dedicating entity, pursuant to § 21.21(c) of this part, is responsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintaining auditable records of the dedication process. NRC enforcement action can be taken for failure to identify and evaluate deviations, failure to report defects and failures to comply, or failure to maintain auditable records.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 21 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 21 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 21.1, 21.2, 21.3, 21.4 21.5, 21.7, 21.8, 21.61, and 21.62.
Secs. 145, 161, 68 Stat. 942, 948, as amended (42 U.S.C. 2165, 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); E.O. 10865, as amended, 3 CFR 1959—1963 Comp., p. 398 (50 U.S.C. 401, note); E.O. 12829, 3 CFR, 1993 Comp., p. 570; E.O. 12958, 3 CFR, 1995 Comp., p. 333; E.O. 12968, 3 CFR, 1995 Comp., p. 396.
Appendix A also issued under 96 Stat. 1051 (31 U.S.C. 9701).
The regulations in this part establish procedures for granting, reinstating, extending, transferring, and terminating access authorizations of licensee personnel, licensee contractors or agents, and other persons (e.g., individuals involved in adjudicatory procedures as set forth in 10 CFR part 2, subpart I) who may require access to classified information.
The regulations in this part apply to licensees and others who may require access to classified information related to a license or an application for a license.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0046.
(b) The approved information collection requirements contained in this part appear in §§ 25.11, 25.17, 25.21, 25.23, 25.25, 25.27, 25.29, 25.31, 25.33, and 25.35.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In §§ 25.17(b), 25.21(c), 25.27(a), 25.29, and 25.31, NRC Form 237 is approved under control number 3150-0050.
(2) In §§ 25.17(c), 25.21(c), 25.27(b), 25.29, and 25.31, SF-86 is approved under control number 3206-0007.
(3) In § 25.21(b), NRC Form 354 is approved under control number 3150-0026.
(4) In § 25.33, NRC Form 136 is approved under control number 3150-0049.
(5) In § 25.35, NRC Form 277 is approved under control number 3150-0051.
Except where otherwise specified, all communications and reports concerning the regulations in this part should be addressed to the Director, Division of Facilities and Security, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
The NRC may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of the regulations of this part, that are—
(a) Authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security; or
(b) Coincidental with one or more of the following:
(1) An application of the regulation in the particular circumstances conflicts with other NRC rules or requirements;
(2) An application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule;
(3) When compliance would result in undue hardship or other costs that significantly exceed those contemplated when the regulation was adopted, or that significantly exceed those incurred by others similarly situated;
(4) When the exemption would result in benefit to the common defense and security that compensates for any decrease in the security that may result from the grant of the exemption;
(5) When the exemption would provide only temporary relief from the applicable regulation and the licensee or applicant has made good faith efforts to comply with the regulation;
(6) When there is any other material circumstance present that was not considered when the regulation was adopted that would be in the public interest to grant an exemption. If this condition is relied on exclusively for satisfying paragraph (b) of this section, the exemption may not be granted until the Executive Director for Operations has consulted with the Commission.
(a) Each licensee or organization employing individuals approved for personnel security access authorization under this part, shall maintain records as prescribed within the part. These records are subject to review and inspection by CSA representatives during security reviews.
(b) Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a) A “Q” access authorization permits an individual access on a need-to-know basis to (1) Secret and Confidential Restricted Data and (2) Secret and Confidential National Security Information including intelligence information, CRYPTO (i.e., cryptographic information) or other classified communications security (COMSEC) information.
(b) An “L” access authorization permits an individual access on a need-to-know basis to Confidential Restricted Data and Secret and Confidential National Security Information other than the categories specifically included in paragraph (a) of this section. In addition, access to certain Confidential COMSEC information is permitted as authorized by a National Communications Security Committee waiver dated February 14, 1985.
(c) Each employee of the Commission is processed for one of the two levels of access authorization. Licensees and other persons will furnish National Security Information and/or Restricted Data to a Commission employee on official business when the employee has the appropriate level of NRC access authorization and need-to-know. Some individuals are permitted to begin NRC employment without an access authorization. However, no NRC employee shall be permitted access to any classified information until the appropriate level of access authorization has been granted to that employee by NRC.
(a) Access authorizations must be requested for licensee employees or other persons (e.g., 10 CFR part 2, subpart I) who need access to classified information in connection with activities under 10 CFR parts 50, 52, 54,70, 72, or 76.
(b) The request must be submitted to the facility CSA. If the NRC is the CSA, the procedures in § 25.17 (c) and (d) will be followed. If the NRC is not the CSA, the request will be submitted to the CSA in accordance with procedures established by the CSA. The NRC will be notified of the request by a letter that includes the name, Social Security number and level of access authorization.
(c) The request must include a completed personnel security packet (see § 25.17(d)) and request form (NRC Form 237) signed by a licensee, licensee contractor official, or other authorized person.
(d)(1) Each personnel security packet submitted must include the following completed forms:
(i) Questionnaire for National Security Positions (SF-86, Parts 1 and 2) (Part 2 is to be completed by the applicant and placed in a sealed envelope which is to be forwarded to NRC unopened. No licensee, licensee contractor official, or other person at a facility is permitted to review Part 2 information);
(ii) Two standard fingerprint cards (FD-258);
(iii) Security Acknowledgment (NRC Form 176); and
(iv) Other related forms where specified in accompanying instructions (NRC Form 254).
(2) Only a Security Acknowledgment (NRC Form 176) need be completed by any person possessing an active access authorization, or who is being processed for an access authorization, by another Federal agency. The active or pending access authorization must be at an equivalent level to that required by the NRC and be based on an adequate investigation of not more than five years old.
(e) To avoid delays in processing requests for access authorizations, each security packet should be reviewed for completeness and correctness (including legibility of response on the forms) before submittal.
(f) Applications for access authorization or access authorization renewal processing that are submitted to the NRC for processing must be accompanied by a check or money order, payable to the United States Nuclear Regulatory Commission, representing the current cost for the processing of each “Q” and “L” access authorization, or renewal request. Access authorization and access authorization renewal fees will be published each time the Office of Personnel Management notifies the NRC of a change in the rates it charges the NRC for the conduct of investigations. Any changed access authorization or access authorization renewal fees will be applicable to each access authorization or access authorization renewal request received upon or after the date of publication. Applications
Each application for an access authorization or access authorization renewal must be submitted to the CSA. If the NRC is the CSA, the application and its accompanying fee must be submitted to the NRC Division of Facilities and Security. If necessary, the NRC Division of Facilities and Security may obtain approval from the appropriate Commission office exercising licensing or regulatory authority before processing the access authorization or access authorization renewal request. If the applicant is disapproved for processing, the NRC Division of Facilities and Security shall notify the submitter in writing and return the original application (security packet) and its accompanying fee.
(a) Following receipt by the CSA of the reports of the personnel security investigations, the record will be reviewed to determine that granting an access authorization or renewal of access authorization will not endanger the common defense and security and is clearly consistent with the national interest. If this determination is made, access authorization will be granted or renewed. If the NRC is the CSA, questions as to initial or continued eligibility will be determined in accordance with part 10 of chapter I. If another agency is the CSA, that agency will, under the requirements of the NISPOM, have established procedures at the facility to resolve questions as to initial or continued eligibility for access authorization. These questions will be determined in accordance with established CSA procedures already in effect for the facility.
(b) The CSA must be promptly notified of developments that bear on continued eligibility for access authorization throughout the period for which the authorization is active (e.g., persons who marry subsequent to the completion of a personnel security packet must report this change by submitting a completed NRC Form 354, “Data Report on Spouse” or equivalent CSA form).
(c)(1) Except as provided in paragraph (c)(2) of this section, an NRC “Q” access authorization must be renewed every five years from the date of issuance. Except as provided in paragraph (c)(2) of this section, an NRC “L” access authorization must be renewed every ten years from the date of issuance. An application for renewal must be submitted at least 120 days before the expiration of the five-year period for a “Q” access authorization and the ten-year period for an “L” access authorization, and must include:
(i) A statement by the licensee or other person that the individual continues to require access to classified National Security Information or Restricted Data; and
(ii) A personnel security packet as described in § 25.17(d).
(2) Renewal applications and the required paperwork are not required for individuals who have a current and active access authorization from another Federal agency and who are subject to a reinvestigation program by that agency that is determined by the NRC to meet the NRC's requirements. (The DOE Reinvestigation Program has been determined to meet the NRC's requirements.) For these individuals, the submission of the SF-86 by the licensee or other person to the other Government agency pursuant to their reinvestigation requirements will satisfy the NRC's renewal submission and paperwork requirements, even if less than five years have passed since the date of issuance or renewal of the NRC “Q” access authorization, or if less than 10 years have passed since the date of issuance or renewal of the NRC “L” access authorization. Any NRC access authorization continued in response to the provisions of this paragraph will, thereafter, not be due for renewal until the date set by the other Government
(3) If the NRC is not the CSA, reinvestigation program procedures and requirements will be set by the CSA.
The determination to grant or renew access authorization will be furnished in writing to the licensee or organization that initiated the request. Upon receipt of the notification of original grant of access authorization, the licensee or organization shall obtain, as a condition for grant of access authorization and access to classified information, an executed “Classified Information Nondisclosure Agreement” (SF-312) from the affected individual. The SF-312 is an agreement between the United States and an individual who is cleared for access to classified information. An employee issued an initial access authorization shall execute a SF-312 before being granted access to classified information. The licensee or other organization shall forward the executed SF-312 to the CSA for retention. If the employee refuses to execute the SF-312, the licensee or other organization shall deny the employee access to classified information and submit a report to the CSA. The SF-312 must be signed and dated by the employee and witnessed. The employee's and witness' signatures must bear the same date. The individual shall also be given a security orientation briefing in accordance with § 95.33 of this chapter. Records of access authorization grant and renewal notification must be maintained by the licensee or other organization for three years after the access authorization has been terminated by the CSA. This information may also be furnished to other representatives of the Commission, to licensees, contractors, or other Federal agencies. Notifications of access authorization will not be given in writing to the affected individual except:
(a) In those cases when the determination was made as a result of a Personnel Security Hearing or by a Personnel Security Review Panel ; or
(b) When the individual also is the official designated by the licensee or other organization to whom written NRC notifications are forwarded.
When a request for an individual's access authorization or renewal of an access authorization is withdrawn or canceled, the requestor shall notify the CSA immediately by telephone so that the single scope background investigation, national agency check with law and credit investigation, or other personnel security action may be discontinued. The requestor shall identify the full name and date of birth of the individual, the date of request, and the type of access authorization or access authorization renewal requested. The requestor shall confirm each telephone notification promptly in writing.
(a) In conjunction with a new request for access authorization (NRC Form 237 or CSA equivalent) for individuals whose cases were previously canceled, new fingerprint cards (FD-257) in duplicate and a new Security Acknowledgment (NRC Form 176), or CSA equivalent, must be furnished to the CSA along with the request.
(b) Additionally, if 90 days or more have elapsed since the date of the last
(a) An access authorization can be reinstated provided that:
(1) No more than 24 months has lapsed since the date of termination of the clearance;
(2) There has been no break in employment with the employer since the date of termination of the clearance;
(3) There is no known adverse information;
(4) The most recent investigation must not exceed 5 years (Top Secret, Q) or 10 years (Secret, L); and
(5) The most recent investigation must meet or exceed the scope of the investigation required for the level of access authorization that is to be reinstated or granted.
(b) An access authorization can be reinstated at the same, or lower, level by submission of a CSA-designated form to the CSA. The employee may not have access to classified information until receipt of written confirmation of reinstatement and an up-to-date personnel security packet will be furnished with the request for reinstatement of an access authorization. A new Security Acknowledgement will be obtained in all cases. Where personnel security packets are not required, a request for reinstatement must state the level of access authorization to be reinstated and the full name and date of birth of the individual to establish positive identification. A fee, equal to the amount paid for an initial request, will be charged only if a new or updating investigation by the NRC is required.
(a) The NRC Division of Facilities and Security may, on request, extend the authorization of an individual who possesses an access authorization in connection with a particular employer or activity to permit access to classified information in connection with an assignment with another employer or activity.
(b) The NRC Division of Facilities and Security may, on request, transfer an access authorization when an individual's access authorization under one employer or activity is terminated, simultaneously with the individual being granted an access authorization for another employer or activity.
(c) Requests for an extension or transfer of an access authorization must state the full name of the person, date of birth, and level of access authorization. The Director, Division of Facilities and Security, may require a new personnel security packet (see § 25.17(c)) to be completed by the applicant. A fee, equal to the amount paid for an initial request, will be charged only if a new or updating investigation by the NRC is required.
(d) The date of an extension or transfer of access authorization may not be used to determine when a request for renewal of access authorization is required. Access authorization renewal requests must be timely submitted, in accordance with § 25.21(c).
(a) Access authorizations will be terminated when:
(1) An access authorization is no longer required;
(2) An individual is separated from the employment or the activity for which he or she obtained an access authorization for a period of 90 days or more; or
(3) An individual, pursuant to 10 CFR part 10 or other CSA-approved adjudicatory standards, is no longer eligible for an access authorization.
(b) A representative of the licensee or other organization that employs the individual whose access authorization will be terminated shall immediately notify the CSA when the circumstances noted in paragraph (a)(1) or (a)(2) of this section exist; inform the individual that his or her access authorization is being terminated, and the reason; and that he or she will be considered for reinstatement of an access authorization if he or she resumes work requiring the authorization.
(c) When an access authorization is to be terminated, a representative of the licensee or other organization shall conduct a security termination briefing of the individual involved, explain the Security Termination Statement (NRC Form 136 or CSA approved form) and have the individual complete the form. The representative shall promptly forward the original copy of the completed Security Termination Statement to CSA.
(a) The number of classified visits must be held to a minimum. The licensee, certificate holder, or other facility shall determine that the visit is necessary and that the purpose of the visit cannot be achieved without access to, or disclosure of, classified information. All classified visits require advanced notification to, and approval of, the organization to be visited. In urgent cases, visit information may be furnished by telephone and confirmed in writing.
(b) Representatives of the Federal Government, when acting in their official capacities as inspectors, investigators, or auditors, may visit a licensee, certificate holder, or other facility without furnishing advanced notification, provided these representatives present appropriate Government credentials upon arrival. Normally, however, Federal representatives will provide advance notification in the form of an NRC Form 277, “Request for Visit or Access Approval,” with the “need-to-know” certified by the appropriate NRC office exercising licensing or regulatory authority and verification of an NRC access authorization by the Division of Facilities and Security.
(c) The licensee, certificate holder, or others shall include the following information on all Visit Authorization Letters (VAL) which they prepare.
(1) Visitor's name, address, and telephone number and certification of the level of the facility security clearance;
(2) Name, date and place of birth, and citizenship of the individual intending to visit;
(3) Certification of the proposed visitor's personnel clearance and any special access authorizations required for the visit;
(4) Name of person(s) to be visited;
(5) Purpose and sufficient justification for the visit to allow for a determination of the necessity of the visit; and
(6) Date or period during which the VAL is to be valid.
(d) Classified visits may be arranged for a 12 month period. The requesting facility shall notify all places honoring these visit arrangements of any change in the individual's status that will cause the visit request to be canceled before its normal termination date.
(e) The responsibility for determining need-to-know in connection with a classified visit rests with the individual who will disclose classified information during the visit. The licensee, certificate holder or other facility shall establish procedures to ensure positive identification of visitors before the disclosure of any classified information.
(a) An injunction or other court order may be obtained to prohibit a violation of any provision of:
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) Any regulation or order issued under these Acts.
(b) National Security Information is protected under the requirements and sanctions of Executive Order 12958.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 25 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 25 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 25.1, 25.3, 25.5, 25.7, 25.8, 25.9, 25.11, 25.19, 25.25, 25.27, 25.29, 25.31, 25.37, and 25.39.
Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930, 935, 936, 937, 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2111, 2112, 2133, 2134, 2137, 2201, 2297f); secs. 201, 202, 206, 88 S at. 1242, 1244, 1246, as amended (42 U.S.C. 5841, 5842, 5846).
This part prescribes requirements and standards for the establishment andmaintenance of certain aspects of fitness-for-duty programs and procedures by the licensed nuclear power industry, and by licensees authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM).
(a) The regulations in this part apply to licensees authorized to operate a nuclear power reactor, to possess or use
(1) Are granted unescorted access to Category IA Material;
(2) Create or have access to procedures or records for safeguarding SSNM;
(3) Make measurements of Category IA Material;
(4) Transport or escort Category IA Material; or
(5) Guard Category IA Material.
(b) The regulations in this part do not apply to NRC employees, to law enforcement personnel, or offsite emergency fire and medical response personnel while responding onsite, or SSNM transporters who are subject to U.S. Department of Transportation drug or alcohol fitness programs that require random testing for drugs and alcohol. The regulations in this part also do not apply to spent fuel storage facility licensees or non-power reactor licensees who possess, use, or transport formula quantities of irradiated SSNM as these materials are exempt from the Category I physical protection requirements as set forth in 10 CFR 73.6.
(c) Certain regulations in this part apply to licensees holding permits to construct a nuclear power plant. Each construction permit holder, with a plant under active construction, shall comply with §§ 26.10, 26.20, 26.23, 26.70, and 26.73 of this part; shall implement a chemical testing program, including random tests; and shall make provisions for employee assistance programs, imposition of sanctions, appeals procedures, the protection of information, and recordkeeping.
(d) The regulations in this part apply to the Corporation required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter only if the Corporation elects to engage in activities involving formula quantities of strategic special nuclear material. When applicable, the requirements apply only to the Corporation and personnel carrying out the activities specified in § 26.2(a)(1) through (5).
(1) The dimensions are large enough (at least 2 meters in one dimension, greater than 1 meter in each of two dimensions, or greater than 25 cm in each of three dimensions) to preclude hiding the item on an individual;
(2) The total weight of 5 formula kilograms of SSNM plus its matrix (at least 50 kilograms) cannot be carried inconspicuously by one person; or
(3) The quantity of SSNM (less than 0.05 formula kilogram) in each container requires protracted diversions in order to accumulate 5 formula kilograms.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
(b) The approved information collection requirements contained in this part appear in §§ 26.6, 26.20, 26.21, 26.22, 26.23, 26.24, 26.25, 26.27, 26.28, 26.29, 26.70, 26.71, 26.73, 26.80, and appendix A to this part.
Fitness-for-duty programs must:
(a) Provide reasonable assurance that nuclear power plant personnel, transporter personnel, and personnel of licensees authorized to possess or use formula quantities of SSNM, will perform their tasks in a reliable and trustworthy manner and are not under the influence of any substance, legal or illegal, or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and competently perform their duties;
(b) Provide reasonable measures for the early detection of persons who are not fit to perform activities within the scope of this part; and
(c) Have a goal of achieving a drug-free workplace and a workplace free of the effects of such substances.
Each licensee subject to this part shall establish and implement written policies and procedures designed to meet the general performance objectives and specific requirements of this part. Each licensee shall retain a copy of the current written policy and procedures as a record until the Commission terminates each license for which the policy and procedures were developed and, if any portion of the policies and procedures are superseded, retain the superseded material for three years after each change. As a minimum, written policies and procedures must address fitness for duty through the following:
(a) An overall description of licensee policy on fitness for duty. The policy must address use of illegal drugs and abuse of legal drugs (e.g., alcohol, prescription and over-the-counter drugs). Written policy documents must be in sufficient detail to provide affected individuals with information on what is expected of them, and what consequences may result from lack of adherence to the policy. As a minimum, the written policy must prohibit the consumption of alcohol—
(1) Within an abstinence period of at least 5 hours preceding any scheduled working tour, and
(2) During the period of any working tour.
(b) A description of programs which are available to personnel desiring assistance in dealing with drug, alcohol, or other problems that could adversely affect the performance of activities within the scope of this part.
(c) Procedures to be utilized in testing for drugs and alcohol, including procedures for protecting the employee and the integrity of the specimen, and the quality controls used to ensure the test results are valid and attributable to the correct individual.
(d) A description of immediate and follow-on actions which will be taken, and the procedures to be utilized, in those cases where employees, vendors, or contractors assigned to duties within the scope of this part are determined to have been involved in the use, sale, or possession of illegal drugs; or to have consumed alcohol during the mandatory pre-work abstinence period, while on duty, or to excess prior to reporting to duty as demonstrated with a test that can be used to determine blood alcohol concentration.
(e) A procedure that will ensure that persons called in to perform an unscheduled working tour are fit to perform the task assigned. As a minimum, this procedure must—
(1) Require a statement to be made by a called-in person as to whether he or she has consumed alcohol within the
(2) If alcohol has been consumed within this period, require a determination of fitness for duty by breath analysis or other means; and
(3) Require the establishment of controls and conditions under which a person who has been called-in can perform work, if necessary, although alcohol has been consumed. Consumption of alcohol during the abstinence period shall not by itself preclude a licensee from using individuals needed to respond to an emergency.
(f) The Commission may at any time review the licensee's written policy and procedures to assure that they meet the performance objectives of this part.
(a) Persons assigned to activities within the scope of this part shall be provided with appropriate training to ensure they understand—
(1) Licensee policy and procedures, including the methods that will be used to implement the policy;
(2) The personal and public health and safety hazards associated with abuse of drugs and misuse of alcohol;
(3) The effect of prescription and over-the-counter drugs and dietary conditions on job performance and on chemical test results, and the role of the Medical Review Officer;
(4) Employee assistance programs provided by the licensee; and
(5) What is expected of them and what consequences may result from lack of adherence to the policy,
(b) Initial training must be completed prior to assignment to activities within the scope of this part. Refresher training must be completed on a nominal 12 month frequency or more frequently where the need is indicated. A record of the training must be retained for a period of at least three years.
(a) Managers and supervisors of activities within the scope of this part must be provided appropriate training to ensure they understand—
(1) Their role and responsibilities in implementing the program;
(2) The roles and responsibilities of others, such as the personnel, medical, and employee assistance program staffs;
(3) Techniques for recognizing drugs and indications of the use, sale, or possession of drugs;
(4) Behavioral observation techniques for detecting degradation in performance, impairment, or changes in employee behavior; and
(5) Procedures for initiating appropriate corrective action, to include referral to the employee assistance program.
(b) Persons assigned to escort duties shall be provided appropriate training in techniques for recognizing drugs and indications of the use, sale, or possession of drugs, techniques for recognizing aberrant behavior, and the procedures for reporting problems to supervisory or security personnel.
(c) Initial training must be completed prior to assignment of duties within the scope of this part and within 3 months after initial supervisory assignment, as applicable. Refresher training must be completed on a nominal 12 month frequency, or more frequently where the need is indicated. A record of the training must be retained for a period of at least three years.
(a) All contractor and vendor personnel performing activities within the scope of this part for a licensee must be subject to either the licensee's program relating to fitness for duty, or to a program, formally reviewed and approved by the licensee, which meets the requirements of this part. Written agreements between licensees and contractors or vendors for activities within the scope of this part must be retained for the life of the contract and will clearly show that—
(1) The contractor or vendor is responsible to the licensee for adhering to the licensee's fitness-for-duty policy, or maintaining and adhering to an effective fitness-for-duty program; which meets the standards of this part; and
(2) Personnel having been denied access or removed from activities within the scope of this part at any nuclear power plant for violations of a fitness-
(b) Each licensee subject to this part shall assure that contractors whose own fitness-for-duty programs are relied on by the licensee adhere to an effective program, which meets the requirements of this part, and shall conduct audits pursuant to § 26.80 for this purpose.
(a) To provide a means to deter and detect substance abuse, the licensee shall implement the following chemical testing programs for persons subject to this part:
(1) Testing within 60 days prior to the initial granting of unescorted access to protected areas or assignment to activities within the scope of this part.
(2) Unannounced drug and alcohol tests imposed in a statistically random and unpredictable manner so that all persons in the population subject to testing have an equal probability of being selected and tested. The tests must be administered so that a person completing a test is immediately eligible for another unannounced test. As a minimum, tests must be administered on a nominal weekly frequency and at various times during the day. Random testing must be conducted at an annual rate equal to at least 50 percent of the workforce.
(3) Testing for-cause, i.e., as soon as possible following any observed behavior indicating possible substance abuse; after accidents involving a failure in individual performance resulting in personal injury, in a radiation exposure or release of radioactivity in excess of regulatory limits, or actual or potential substantial degradations of the level of safety of the plant if there is reasonable suspicion that the worker's behavior contributed to the event; or after receiving credible information that an individual is abusing drugs or alcohol.
(4) Follow-up testing on an unannounced basis to verify continued abstention from the use of substances covered under this part.
(b) Testing for drugs and alcohol, at a minimum, must conform to the “Guidelines for Drug and Alcohol Testing Programs,” issued by the Nuclear Regulatory Commission and appearing in appendix A to this part, hereinafter referred to as the NRC Guidelines. Licensees, at their discretion, may implement programs with more stringent standards (e.g., lower cutoff levels, broader panel of drugs). All requirements in this part still apply to persons who fail a more stringent standard, but do not test positive under the NRC Guidelines. Management actions must be the same with the more stringent standards as if the individual had failed the NRC standards.
(c) Licensees shall test for all substances described in paragraph 2.1(a) of the NRC Guidelines. In addition, licensees may consult with local law enforcement authorities, hospitals, and drug counseling services to determine whether other substances with abuse potential are being used in the geographical locale of the facility and the local workforce. When appropriate, other substances so identified may be added to the panel of substances for testing. Appropriate cutoff limits must be established by the licensee for these substances.
(d)(1) Licensees may conduct initial screening tests of an aliquot before forwarding selected specimens to a laboratory certified by the Department of Health and Human Services (HHS), provided the licensee's staff possesses the necessary training and skills for the tasks assigned, the staff's qualifications are documented, and adequate quality controls for the testing are implemented. Quality control procedures for initial screening tests by a licensee's testing facility must include the processing of blind performance test specimens and the submission to the HHS-certified laboratory of a sampling of specimens initially tested as negative. Except for the purposes discussed below, access to the results of preliminary tests must be limited to the licensee's testing staff, the Medical Review Officer (MRO), the Fitness-for-Duty Program Manager, and the employee assistance program staff, when appropriate.
(2) No individual may be removed or temporarily suspended from unescorted
(i) For the drug for which action will be taken, at least 85 percent of the specimens which were determined to be presumptively positive as a result of preliminary onsite screening tests during the last 6-month data reporting period submitted to the Commission under § 26.71(d) were subsequently reported as positive by the HHS-certified laboratory as the result of a GC/MS confirmatory test.
(ii) There is no loss of compensation or benefits to the tested person during the period of temporary administrative action.
(iii) Immediately upon receipt of a negative report from the HHS-certified laboratory, any matter which could link the individual to a temporary suspension is eliminated from the tested individual's personnel record or other records.
(iv) No disclosure of the temporary removal or suspension of, or other administrative action against, an individual whose test is not subsequently confirmed as positive by the MRO may be made in response to a suitable inquiry conducted under the provisions of § 26.27(a), a background investigation conducted under the provisions of § 73.56, or to any other inquiry or investigation. For the purpose of assuring that no records have been retained, access to the system of files and records must be provided to licensee personnel conducting appeal reviews, inquiries into an allegation, or audits under the provisions of § 26.80, or to an NRC inspector or other Federal officials. The tested individual must be provided a statement that the records in paragraph (d)(2)(iii) of this section have not been retained and must be informed in writing that the temporary removal or suspension or other administrative action that was taken will not be disclosed, and need not be disclosed by the individual, in response to requests for information concerning removals, suspensions, administrative actions or history of substance abuse.
(e) The Medical Review Officer's review of the test results must be completed and licensee management notified within 10 days of the initial presumptive positive screening test.
(f) All testing of specimens for urine drug testing, except onsite testing under paragraph (d) above, must be performed in a laboratory certified by the U.S. Department of Health and Human Services for that purpose consistent with its standards and procedures for certification. Except for suspect specimens submitted for special processing (Section 2.7(d) of appendix A), all specimens sent to certified laboratories shall be subject to initial screening by the laboratory and all specimens screened as presumptively positive shall be subject to confirmation testing by the laboratory. Licensees shall submit blind performance test specimens to certified laboratories in accordance with the NRC Guidelines (appendix A).
(g) Tests for alcohol must be administered by breath analysis using breath alcohol analyses devices meeting evidential standards described in section 2.7(O)(3) of appendix A. A breath alcohol content indicating a blood alcohol concentration of 0.04 percent or greater must be a positive test result. The confirmatory test for alcohol shall be done with another breath measurement instrument. Should the person demand further confirmation, the test must be a gas chromatography analysis of blood.
Each licensee subject to this part shall maintain an employee assistance program to strengthen fitness-for-duty
(a)(1) The licensee shall obtain a written statement from the individual as to whether activities within the scope of this part were ever denied the individual before the initial—
(i) Granting of unescorted access to a nuclear power plant protected area;
(ii) Granting of unescorted access by a formula quantity SSNM licensee to Category IA Material;
(iii) Assignment to create or the initial granting of access to safeguards of procedures for SSNM;
(iv) Assignment to measure Category IA Material;
(v) Assignment to transport or escort Category IA Material;
(vi) Assignment to guard Category IA Material; or
(vii) Assignment to activities within the scope of this part to any person.
(2) The licensee, as applicable, shall complete a suitable inquiry on a best-efforts basis to determine if that person was, in the past—
(i) Tested positive for drugs or use of alcohol that resulted in on-duty impairment;
(ii) Subject to a plan for treating substance abuse (except for self-referral for treatment);
(iii) Removed from activities within the scope of this part;
(iv) Denied unescorted access at any other nuclear power plant;
(v) Denied unescorted access to SSNM;
(vi) Removed from responsibilities to create or have access to safeguards records or procedures for SSNM;
(vii) Removed from responsibilities to measure SSNM;
(viii) Removed from the responsibilities of transporting or escorting SSNM; or
(ix) Removed from the responsibilities of guarding SSNM at any other facility in accordance with a fitness-for-duty policy.
(3) If a record of the type described in paragraph (a)(2) of this section is established, the new assignment to activities within the scope of this part or granting of unescorted access must be based upon a management and medical determination of fitness for duty and the establishment of an appropriate follow-up testing program, provided the restrictions of paragraph (b) of this section are observed. To meet this requirement, the identity of persons denied unescorted access or removed under the provisions of this part and the circumstances for the denial or removal, including test results, will be made available in response to a licensee's, contractor's or vendor's inquiry supported by a signed release from the individual.
(4) Failure to list reasons for removal or revocation of unescorted access is sufficient cause for denial of unescorted access. Temporary access provisions are not affected by this part if the prospective worker passes a chemical test conducted according to the requirements of § 26.24(a)(1).
(b) Each licensee subject to this part shall, as a minimum, take the following actions. Nothing herein shall prohibit the licensee from taking more stringent action.
(1) Impaired workers, or those whose fitness may be questionable, shall be removed from activities within the scope of this part, and may be returned only after determined to be fit to safely and competently perform activities within the scope of this part.
(2) Lacking any other evidence to indicate the use, sale, or possession of illegal drugs onsite, a confirmed positive test result must be presumed to be an indication of offsite drug use. The first confirmed positive test must, as a minimum, result in immediate removal from activities within the scope of this part for at least 14 days and referral to the EAP for assessment and counseling
(i) Removal from unescorted access to nuclear power plant protected areas;
(ii) Removal from unescorted access to Category IA Material;
(iii) Removal from responsibilities to create or have access to records or procedures for safeguarding SSNM;
(iv) Removal from responsibilities to measure Category IA Material;
(v) Removal from the responsibilities of transporting or escorting Category IA Material;
(vi) Removal from the responsibilities of guarding Category IA Material at any other licensee facility; and
(vii) Removal from activities within the scope of this part for a minimum of 3 years from the date of removal.
(3) Any individual determined to have been involved in the sale, use, or possession of illegal drugs, while, as applicable, within a protected area of any nuclear power plant, within a facility that is licensed to possess or use SSNM, or within a transporter's facility or vehicle, must be removed from activities within the scope of this part. The individual may not—
(i) Be granted unescorted access to nuclear power plant protected areas;
(ii) Be granted unescorted access to Category IA Material;
(iii) Be given responsibilities to create or have access to safeguards records or procedures for SSNM;
(iv) Be given responsibilities to measure Category IA Material;
(v) Be given responsibilities to transport or escort Category IA Material;
(vi) Be given responsibilities to guard Category IA Material; or
(vii) Be assigned to activities within the scope of this part for a minimum of 5 years from the date of removal.
(4) Persons removed for periods of three years or more under the provisions of paragraphs (b) (2) and (3) of this section for the illegal sale, use or possession of drugs and who would have been removed under the current standards of a hiring licensee, may be granted unescorted access and assigned duties within the scope of this part by a licensee subject to this part only when the hiring licensee receives satisfactory medical assurance that the person has abstained from drugs for at least three years. Satisfactory management and medical assurance of the individual's fitness to adequately perform activities within the scope of this part must be obtained before permitting the individual to perform activities within the scope of this part. Any person granted unescorted access or whose access is reinstated under these provisions must be given unannounced follow-up tests at least once every month for four months and at least once every three months for the next two years and eight months after unescorted access is reinstated to verify continued abstinence from proscribed substances. Any confirmed use of drugs through this process or any other determination of subsequent involvement in the sale, use or possession of illegal substances must result in permanent denial of unescorted access.
(5) Paragraphs (b) (2), (3), and (4) of this section do not apply to alcohol, valid prescriptions, or over-the-counter drugs. Licensee sanctions for confirmed misuse of alcohol, valid prescription, and over-the-counter drugs shall be sufficient to deter abuse of legally obtainable substances as a substitute for abuse of proscribed drugs.
(c) Refusal to provide a specimen for testing and resignation prior to removal for violation of company fitness-for-duty policy concerning drugs must be recorded as removals for cause. These records must be retained for the purpose of meeting the requirements of § 26.27(a).
(d) If a licensee has a reasonable belief that an NRC employee may be under the influence of any substance, or otherwise unfit for duty, the licensee may not deny access but shall escort the individual. In any instance
Each licensee subject to this part, and each contractor or vendor implementing a fitness-for-duty program under the provisions of § 26.23, shall establish a procedure for licensee and contractor or vendor employees to appeal a positive alcohol or drug determination. The procedure must provide notice and an opportunity to respond and may be an impartial internal management review. A licensee review procedure need not be provided to employees of contractors or vendors when the contractor or vendor is administering his own alcohol and drug testing.
(a) Each licensee subject to this part, who collects personal information on an individual for the purpose of complying with this part, shall establish and maintain a system of files and procedures for the protection of the personal information. This system must be maintained until the Commission terminates each license for which the system was developed.
(b) Licensees, contractors, and vendors shall not disclose the personal information collected and maintained to persons other than assigned Medical Review Officers, other licensees or their authorized representatives legitimately seeking the information as required by this part for unescorted access decisions and who have obtained a release from current or prospective employees or contractor personnel, NRC representatives, appropriate law enforcement officials under court order, the subject individual or his or her representative, or to those licensee representatives who have a need to have access to the information in performing assigned duties, including audits of licensee's, contractor's, and vendor's programs, to persons deciding matters on review or appeal, and to other persons pursuant to court order. This section does not authorize the licensee, contractor, or vendor to withhold evidence of criminal conduct from law enforcement officials.
(a) Each licensee subject to this part shall permit duly authorized representatives of the Commission to inspect, copy, or take away copies of its records and inspect its premises, activities, and personnel as may be necessary to accomplish the purposes of this part.
(b) Written agreements between licensees and their contractors and vendors must clearly show that the—
(1) Licensee is responsible to the Commission for maintaining an effective fitness-for-duty program in accordance with this part; and
(2) Duly authorized representatives of the Commission may inspect, copy, or take away copies of any licensee, contractor, or vendor's documents, records, and reports related to implementation of the licensee's, contractor's, or vendor's fitness-for-duty program under the scope of the contracted activities.
Each licensee subject to this part and each contractor and vendor implementing a licensee approved program under the provisions of § 26.23 shall—
(a) Retain records of inquiries conducted in accordance with § 26.27(a), that result in the granting of unescorted access to protected areas, until five years following termination of such access authorizations;
(b) Retain records of confirmed positive test results which are concurred in by the Medical Review Officer, and the related personnel actions for a period of at least five years;
(c) Retain records of persons made ineligible for three years or longer for assignment to activities within the scope of this part under the provisions of § 26.27(b) (2), (3), (4) or (c), until the Commission terminates each license under which the records were created; and
(d) Collect and compile fitness-for-duty program performance data on a standard form and submit this data to
(a) Each licensee subject to this part shall inform the Commission of significant fitness-for-duty events including:
(1) Sale, use, or possession of illegal drugs within the protected area and,
(2) Any acts by any person licensed under 10 CFR part 55 to operate a power reactor or by any supervisory personnel assigned to perform duties within the scope of this part—
(i) Involving the sale, use, or possession of a controlled substance,
(ii) Resulting in confirmed positive tests on such persons,
(iii) Involving use of alcohol within the protected area, or
(iv) Resulting in a determination of unfitness for scheduled work due to the consumption of alcohol.
(b) Notifications must be made to the NRC Operations Center by telephone within 24 hours of the discovery of the event by the licensee.
(c) Fitness-for-duty events shall be reported under this section rather than reported under the provisions of § 73.71.
(d) By November 30, 1993 each licensee who is authorized to possess, use, or transport formula quantities of SSNM shall certify to the NRC that it has implemented a fitness-for-duty program that meets the requirements of 10 CFR part 26. The certification shall describe any licensee cut-off levels more stringent than those imposed by this part.
(a) Each licensee subject to this part shall audit the fitness-for-duty program nominally every 12 months. In addition, audits must be conducted, nominally every 12 months, of those portions of fitness-for-duty programs implemented by contractors and vendors. Licensees may accept audits of contractors and vendors conducted by other licensees and need not re-audit the same contractor or vendor for the same period of time. Each sharing utility shall maintain a copy of the audit report, to include findings, recommendations and corrective actions. Licensees retain responsibility for the effectiveness of contractor and vendor programs and the implementation of appropriate corrective action.
(b) Audits must focus on the effectiveness of the program and be conducted by individuals qualified in the subject(s) being audited, and independent of both fitness-for-duty program management and personnel directly responsible for implementation of the fitness-for-duty program.
(c) The result of the audit, along with recommendations, if any, must be documented and reported to senior corporate and site management. The resolution of the audit findings and corrective actions must be documented. These documents must be retained for three years. NRC Guidelines require licensee audits of HHS-certified laboratories as described in appendix A.
(a) An injunction or other court order may be obtained to prohibit a violation of any provision of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974; or
(3) Any regulation or order issued under these Acts.
(b) A court order may be obtained for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act of 1954, for violations of—
(1) Section 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Act;
(2) Section 206 of the Energy Reorganization Act of 1974;
(3) Any rule, regulation, or order issued under these Sections;
(4) Any term, condition, or limitation of any license issued under these Sections; or
(5) Any provisions for which a license may be revoked under section 186 of the Atomic Energy Act of 1954.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 26 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 26 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 26.1, 26.2, 26.3, 26.4, 26.6, 26.8, 26.90, and 26.91.
(1) These guidelines apply to licensees authorized to operate nuclear power reactors and licensees who are authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM).
(2) Licensees may set more stringent cut-off levels than specified herein or test for substances other than specified herein and shall inform the Commission of such deviation within 60 days of implementing such change. Licensees may not deviate from the provisions of these guidelines without the written approval of the Commission.
(3) Only laboratories which are HHS-certified are authorized to perform urine drug testing for NRC licensees, vendors, and licensee contractors.
For the purposes of this part, the following definitions apply:
“Aliquot.” A portion of a specimen used for testing.
“BAC.” Blood alcohol concentration (BAC), which can be measured directly from blood or derived from a measure of the concentration of alcohol in a breath specimen, is a measure of the mass of alcohol in a volume of blood such that an individual with 100 mg of alcohol per 100 ml of blood has a BAC of 0.10 percent.
“Commission.” The U.S. Nuclear Regulatory Commission or its duly authorized representatives.
“Chain-of-custody.” Procedures to account for the integrity of each specimen by tracking its handling and storage from the point of specimen collection to final disposition of the specimen.
“Collection site.” A place designated by the licensee where individuals present themselves for the purpose of providing a specimen of their urine, breath, and/or blood to be analyzed for the presence of drugs or alcohol.
“Collection site person.” A person who instructs and assists individuals at a collection site and who receives and makes an initial examination of the specimen(s) provided by those individuals. A collection site person shall have successfully completed training to carry out this function or shall be a licensed medical professional or technician who is provided instructions for collection under this part and certifies completion as required herein. In any case where: (a) a collection is observed or (b) collection is monitored by nonmedical personnel, the collection site person must be a person of the same gender as the donor.
“Confirmatory test.” A second analytical procedure to identify the presence of a specific drug or drug metabolite which is independent of the initial screening test and which uses a different technique and chemical principle from that of the initial test in order to ensure reliability and accuracy. (At this time gas chromatography/mass spectrometry [GC/MS] is the only authorized confirmation method for cocaine, marijuana, opiates, amphetamines, phencyclidine). For determining blood alcohol levels, a “confirmatory test” means a second test using another breath alcohol analysis device. Further confirmation upon demand will be by gas chromatography analysis of blood.
“Confirmed positive test.” The result of a confirmatory test that has established the presence of drugs, drug metabolites, or alcohol in a specimen at or above the cut-off level, and that has been deemed positive by the Medical Review Officer (MRO) after evaluation. A “confirmed positive test” for alcohol can also be obtained as a result of a confirmation of blood alcohol levels with a second breath analysis without MRO evaluation.
“HHS-certified laboratory.” A urine and blood testing laboratory that maintains certification to perform drug testing under the Department of Health and Human Services (HHS) “Mandatory Guidelines for Federal Workplace Drug Testing Programs” (53 FR 11970).
“Illegal drugs.” Those drugs included in Schedules I through V of the Controlled Substances Act (CSA), but not when used pursuant to a valid prescription or when used as otherwise authorized by law.
“Initial or screening test.” An immunoassay screen for drugs or drug metabolites to eliminate “negative” urine specimens from further consideration or the first breathalyzer test for alcohol.
“Licensee's testing facility.” A drug testing facility operated by the licensee or one of its vendors or contractors to perform the initial testing of urine samples and to perform initial breath tests for alcohol. Such a testing facility is optional and not required to maintain HHS certification under this part.
“Medical Review Officer.” A licensed physician responsible for receiving laboratory results generated by an employer's drug testing program who has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate an individual's positive test result together with his or her medical history and any other relevant biomedical information.
“Permanent record book.” A permanently bound book in which identifying data on each specimen collected at a collection site are permanently recorded in the sequence of collection.
“Reason to believe.” Reason to believe that a particular individual may alter or substitute the urine specimen.
“Split sample.” A portion of a urine specimen that may be stored by the licensee to be tested in the event of appeal.
(a) Licensees shall, as a minimum, test for marijuana, cocaine, opiates, amphetamines, phencyclidine, and alcohol for pre-access, for-cause, random, and follow-up tests.
(b) Licensees may test for any illegal drugs during a for-cause test, or analysis of any specimen suspected of being adulterated or diluted through hydration or other means.
(c) Licensees shall establish rigorous testing procedures that are consistent with the intent of these guidelines for any other drugs not specified in these guidelines for which testing is authorized under 10 CFR 26, so that the appropriateness of the use of these substances can be evaluated by the Medical Review Officer to ensure that individuals granted unescorted access are fit for maintaining access to and for performing duties in protected areas.
(d) Specimens collected under NRC regulations requiring compliance with this part may only be designated or approved for testing as described in this part and shall not be used to conduct any other analysis or test without the permission of the tested individual.
(e) This section does not prohibit procedures reasonably incident to analysis of a specimen for controlled substances (e.g., determination of pH on tests for specific gravity, creatinine concentration, or presence of adulterants).
The licensee testing facilities and HHS-certified laboratories described in this part shall develop and maintain clear and well-
(a) Use of a chain-of-custody form. The original shall accompany the specimen to the HHS-certified laboratory. A copy shall accompany any split sample. The form shall be a permanent record on which is retained identity data (or codes) on the employee and information on the specimen collection process and transfers of custody of the specimen.
(b) Use of a tamperevident sealing system designed in a manner such that the specimen container top can be sealed against undetected opening, the container can be identified with a unique identifying number identical to that appearing on the chain-of-custody form, and space has been provided to initial the container affirming its identity. For purposes of clarity, this requirement assumes use of a system made up of one or more pre-printed labels and seals (or a unitary label/seal), but use of other, equally effective technologies is authorized.
(c) Use of a shipping container in which one or more specimens and associated paperwork may be transferred and which can be sealed and initialled to prevent undetected tampering.
(d) Written procedures, instructions, and training shall be provided as follows:
(1) Licensee collection site procedures and training of collection site personnel shall clearly emphasize that the collection site person is responsible for maintaining the integrity of the specimen collection and transfer process, carefully ensuring the modesty and privacy of the individual tested, and is to avoid any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate.
(2) A non-medical collection site person shall receive training in compliance with this appendix and shall demonstrate proficiency in the application of this appendix prior to serving as a collection site person. A medical professional, technologist, or technician licensed or otherwise approved to practice in the jurisdiction in which collection occurs may serve as a collection site person if that person is provided the instructions described in 2.2(3) and performs collections in accordance with those instructions.
(3) Collection site persons shall be provided with detailed, clearly-illustrated, written instructions on the collection of specimens in compliance with this part. Individuals subject to testing shall also be provided standard written instructions setting forth their responsibilities.
(4) The option to provide a blood specimen for confirmatory analysis following a positive breath test shall be specified in the written instructions provided to individuals tested. The instructions shall also state that failure to request a confirmatory blood test indicates that the individual accepts the breath test results.
Licensees shall carefully select and monitor persons responsible for administering the testing program (e.g., collection site persons, laboratory technicians, specimen couriers, and those selecting and notifying personnel to be tested), based upon the highest standards for honesty and integrity, and shall implement measures to ensure that these standards are maintained. As a minimum, these measures shall ensure that the integrity of such persons is not compromised or subject to efforts to compromise due to personal relationships with any individuals subject to testing.
As a minimum:
(1) Supervisors, co-workers, and relatives of the individual being tested shall not perform any collection, assessment, or evaluation procedures.
(2) Appropriate background checks and psychological evaluations shall be completed prior to assignment of any tasks associated with the administration of the program, and shall be conducted at least once every three years.
(3) Persons responsible for administering the testing program shall be subjected to a behavioral observation program designed to assure that they continue to meet the highest standards for honesty and integrity.
(a) “Designation of Collection Site.” Each drug testing program shall have one or more designated collection sites which have all necessary personnel, materials, equipment, facilities, and supervision to provide for the collection, security, temporary storage, and shipping or transportation of urine or blood specimens to a drug testing laboratory. A properly equipped mobile facility that meets the requirements of this part is an acceptable collection site.
(b) “Collection Site Person.” A collection site person shall have successfully completed training to carry out this function. In any case where the collection of urine is observed, the collection site person must be a person of the same gender as the donor. Persons drawing blood shall be qualified to perform that task.
(c) “Security.” The purpose of this paragraph is to prevent unauthorized access which could compromise the integrity of the collection process or the specimen. Security procedures shall provide for the designated collection site to be secure. If a collection site facility cannot be dedicated solely to drug and alcohol testing, the portion of the facility used for testing shall be secured during that testing.
(1) A facility normally used for other purposes, such as a public rest room or hospital examining room, may be secured by visual inspection to ensure other persons are not present, and that undetected access (e.g., through a rear door not in the view of the collection site person) is impossible. Security during collection may be maintained by effective restriction of access to collection materials and specimens. In the case of a public rest room, the facility must be posted against access during the entire collection procedure to avoid embarrassment to the individual or distraction of the collection site person.
(2) If it is impractical to maintain continuous physical security of a collection site from the time the specimen is presented until the sealed container is transferred for shipment, the following minimum procedures shall apply: The specimen shall remain under the direct control of the collection site person from delivery to its being sealed in a mailer or secured for shipment. The mailer shall be immediately mailed, maintained in secure storage, or remain until mailed under the personal control of the collection site person. These minimum procedures shall apply to the mailing of specimens to licensee testing facilities from collection sites (except where co-located) as well as to the mailing of specimens to HHS-certified laboratories. As an option, licensees may ship several specimens via courier in a locked or sealed shipping container.
(d) “Chain-of-Custody.” Licensee chain-of-custody forms shall be properly executed by authorized collection site personnel upon receipt of specimens. Handling and transportation of urine and blood specimens from one authorized individual or place to another shall always be accomplished through chain-of-custody procedures. Every effort shall be made to minimize the number of persons handling the specimens.
(e) “Access to Authorized Personnel Only.” No unauthorized personnel shall be permitted in any part of the designated collection site where specimens are collected or stored. Only the collection site person may handle specimens prior to their securement in the mailing or shipping container or monitor or observe specimen collection (under the conditions specified in this part). In order to promote security of specimens, avoid distraction of the collection site person, and ensure against any confusion in the identification of specimens, a collection site person shall conduct only one collection procedure at any given time. For this purpose, a collection procedure is complete when the specimen container has been sealed and initialed, the chain-of-custody form has been executed, and the individual has departed the collection site.
(f) “Privacy.” Procedures for collecting urine specimens shall allow individual privacy unless there is reason to believe that a particular individual may alter or substitute the specimen to be provided. For purposes of this appendix the following circumstances are the exclusive grounds constituting a reason to believe that the individual may alter or substitute a urine specimen:
(1) The individual has presented a urine specimen that falls outside the normal temperature range, and the individual declines to provide a measurement of oral body temperature by sterile thermometer, as provided in paragraph (g)(14) of this appendix, or the oral temperature does not equal or exceed that of the specimen.
(2) The last urine specimen provided by the individual (i.e., on a previous occasion) was determined by the laboratory to have a specific gravity of less than 1.003 or a creatinine concentration below .2 g/L.
(3) The collection site person observes conduct clearly and unequivocally indicating an attempt to substitute or adulterate the sample (e.g., substitute urine in plain view, blue dye in specimen presented, etc.).
(4) The individual has previously been determined to have used a substance inappropriately or without medical authorization and the particular test is being conducted as a part of a rehabilitation program or on return to service after evaluation and/or treatment for a confirmed positive test result.
(g) “Integrity and Identity of Specimens.” Licensees shall take precautions to ensure that a urine specimen is not adulterated or diluted during the collection procedure, that a blood sample or breath exhalent tube cannot be substituted or tampered with, and that the information on the specimen container and in the record book can identify the individual from whom the specimen was collected. The following minimum precautions shall be taken to ensure that authentic specimens are obtained and correctly identified:
(1) To deter the dilution of urine specimens at the collection site, toilet bluing agents shall be placed in toilet tanks wherever possible, so the reservoir of water in the toilet bowl always remains blue. There shall be no other source of water (e.g., no shower or sink) in the enclosure where urination occurs. If there is another source of water in the enclosure, it shall be effectively secured or monitored to ensure it is not used (undetected) as a source for diluting the specimen.
(2) When an individual arrives at the collection site for a urine or breath test, the collection site person shall ensure that the individual is positively identified as the person selected for testing (e.g., through presentation of photo identification or identification by the employer's representative). If the individual's identity cannot be established, the collection site person shall not proceed with the collection.
(3) If the individual fails to arrive for a urine or breath test at the assigned time, the collection site person shall contact the appropriate authority to obtain guidance on the action to be taken.
(4) After the individual has been positively identified, the collection site person shall ask the individual to sign a consent-to-testing form and to list all of the prescription medications and over-the-counter preparations that he or she can remember using within the past 30 days.
(5) The collection site person shall ask the individual to remove any unnecessary outer garments such as a coat or jacket that might conceal items or substances that could be used to tamper with or adulterate the individual's urine, breath, or blood specimen. The collection site person shall ensure that all personal belongings such as a purse or briefcase remain with the outer garments outside of the room in which the blood, breath, or urine sample is collected. The individual may retain his or her wallet.
(6) The individual shall be instructed to wash and dry his or her hands prior to urination.
(7) After washing hands prior to urination, the individual shall remain in the presence of the collection site person and shall not have access to any water fountain, faucet, soap dispenser, cleaning agent or any other materials which could be used to adulterate the urine specimen.
(8) The individual may provide his/her urine specimen in the privacy of a stall or otherwise partitioned areas that allows for individual privacy.
(9) The collection site person shall note any unusual behavior or appearance in the permanent record book and on the chain-of-custody form.
(10) In the exceptional event that a designated collection site is inaccessible and there is an immediate requirement for urine specimen collection (e.g., an accident investigation), a public or on-site rest room may be used according to the following procedures. A collection site person of the same gender as the individual shall accompany the individual into the rest room which shall be made secure during the collection procedure. If possible, a toilet bluing agent shall be placed in the bowl and any accessible toilet tank. The collection site person shall remain in the rest room, but outside the stall, until the specimen is collected. If no bluing agent is available to deter specimen dilution, the collection site person shall instruct the individual not to flush the toilet until the specimen is delivered to the collection site person. After the collection site person has possession of the specimen, the individual will be instructed to flush the toilet and to participate with the collection site person in completing the chain-of-custody procedures.
(11) Upon receiving a urine specimen from the individual, the collection site person shall determine that it contains at least 60 milliliters of urine. If there is less than 60 milliliters of urine in the container, additional urine shall be collected in a separate container to reach a total of 60 milliliters. (The temperature of the partial specimen in each separate container shall be measured in accordance with paragraph (f)(13) of this section, and the partial specimens shall be combined in one container.) The individual may be given a reasonable amount of liquid to drink for this purpose (e.g., a glass of water). If the individual fails for any reason to provide 60 milliliters of urine, the collection site person shall contact the appropriate authority to obtain guidance on the action to be taken.
(12) After the urine specimen has been provided and submitted to the collection site person, the individual shall be allowed to wash his or her hands.
(13) Immediately after the urine specimen is collected, the collection site person shall measure the temperature of the specimen. The temperature measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen. The time from urination to temperature measurement is critical and in no case shall exceed 4 minutes.
(14) If the temperature of a urine specimen is outside the range of 32.5°- 37.7 °C/90.5°-99.8 °F, that is a reason to believe that the individual may have altered or substituted the specimen, and another specimen shall be collected under direct observation of a same gender collection site person and both specimens shall be forwarded to the laboratory for testing. An individual may volunteer to have his or her oral temperature taken to provide evidence to counter the reason to believe the individual may have altered or substituted the specimen caused by the specimen's temperature falling outside the prescribed range.
(15) Immediately after a urine specimen is collected, the collection site person shall also inspect the specimen to determine its color and look for any signs of contaminants. Any unusual findings shall be noted in the permanent record book.
(16) All urine specimens suspected of being adulterated or found to be diluted shall be forwarded to the laboratory for testing.
(17) Whenever there is reason to believe that a particular individual may alter or substitute the urine specimen to be provided, a second specimen shall be obtained as soon as possible under the direct observation of a same gender collection site person. Where appropriate, measures will be taken to prevent additional hydration.
(18) Alcohol breath tests shall be delayed at least 15 minutes if any source of mouth alcohol (e.g., breath fresheners) or any other
(19) If the alcohol breath tests indicates that the individual is positive for a BAC at or above the 0.04 percent cut-off level, the individual may request a confirmatory blood test, at his or her discretion. All vacuum tube and needle assemblies used for blood collection shall be factory-sterilized. The collection site person shall ensure that they remain properly sealed until used. Antiseptic swabbing of the skin shall be performed with a nonethanol antiseptic. Sterile procedures shall be followed when drawing blood and transferring the blood to a storage container; in addition, the container must be sterile and sealed.
(20) Both the individual being tested and the collection site person shall keep urine and blood specimens in view at all times prior to their being sealed and labeled. If a urine specimen is split (as described in Section 2.7(j)) and if any specimen is transferred to a second container, the collection site person shall request the individual to observe the splitting of the urine sample or the transfer of the specimen and the placement of the tamperevident seal over the container caps and down the sides of the containers.
(21) The collection site person and the individual shall be present at the same time during procedures outlined in paragraphs (h) through (j) of this section.
(22) The collection site person shall place securely on each container an identification label which contains the date, the individual's specimen number, and any other identification information provided or required by the drug testing program. If separate from the labels, the tamperevident seals shall also be applied.
(23) The individual shall initial the identification labels on the specimen containers for the purpose of certifying that it is the specimen collected from him or her.
(i) The individual shall be asked to read and sign a statement on either the chain-of-custody form or in the permanent record book certifying that the specimens identified as having been collected from him or her are in fact the specimen he or she provided.
(ii) The individual shall be provided an opportunity to set forth on the urine chain-of-custody form information concerning medications taken or administered in the past 30 days.
(24) The collection site person shall enter in the permanent record book all information identifying the specimens. The collection site person shall sign the permanent record book next to the identifying information.
(25) A higher level supervisor in the drug testing program shall review and concur in advance with any decision by a collection site person to obtain a urine specimen under the direct observation of a same gender collection site person based on a reason to believe that the individual may alter or substitute the specimen to be provided.
(26) The collection site person shall complete the chain-of-custody forms for both the aliquot and the split sample, if collected, and shall certify proper completion of the collection.
(27) The specimens and chain-of-custody forms are now ready for transfer to the laboratory or the licensee's testing facility. If the specimens are not immediately prepared for shipment, they shall be appropriately safeguarded during temporary storage.
(28) While any part of the above chain-of-custody procedures is being performed, it is essential that the specimens and custody documents be under the control of the involved collection site person. The collection site person shall not leave the collection site in the interval between presentation of the specimen by the individual and securement of the samples with identifying labels bearing the individual's specimen identification numbers and seals initialled by the individual. If the involved collection site person leaves his or her work station momentarily, the specimens and chain-of-custody forms shall be taken with him or her or shall be secured. If the collection site person is leaving for an extended period of time, the specimens shall be packaged for transfer to the laboratory before he or she leaves the site.
(h) “Collection Control.” To the maximum extent possible, collection site personnel shall keep the individual's specimen containers within sight both before and after the individual has urinated or provided a breath or blood sample. After the specimen is collected and whenever urine specimens are split, they shall be properly sealed and labeled. A chain-of-custody form shall be used for maintaining control and accountability of each specimen from the point of collection to final disposition of the specimen. The date and purpose shall be documented on the chain-of-custody form each time a specimen is handled or transferred, and every individual in the chain of custody
(i) “Transportation to Laboratory or Testing Facility.” Collection site personnel shall arrange to transfer the collected specimens to the drug testing laboratory or licensee testing facility. To transfer specimens off-site for initial screening and for a second screen and confirmatory analysis of presumptive positive specimens and for transferring suspect specimens to a laboratory for analysis under special processing [Section 2.7(d)], the specimens shall be placed in containers designed to minimize the possibility of damage during shipment (e.g., specimen boxes, padded mailers, or bulk shipping containers with that capability) and those containers shall be securely sealed to eliminate the possibility of undetected tampering. On the tape sealing the container, the collection site person shall sign and enter the date specimens were sealed in the containers for shipment. The collection site personnel shall ensure that the chain-of-custody documentation is attached to each container sealed for shipment to the drug testing laboratory.
(j) “Failure to Cooperate.” If the individual refuses to cooperate with the urine collection or breath analysis process (e.g., refusal to provide a complete specimen, complete paperwork, initial specimen), then the collection site person shall inform the Medical Review Officer and shall document the non-cooperation in the permanent record book and on the specimen custody and control form. The Medical Review Officer shall report the failure to cooperate to the appropriate management. The provision of blood specimens for use to confirm a positive breath test for alcohol shall be entirely voluntary, at the individual's discretion. In the absence of a voluntary blood test the second positive breath test shall be considered a confirmed positive.
(a) “Day-to-Day Management of the HHS-certified Laboratories.”
(1) The HHS-certified laboratory shall have a qualified individual to assume professional, organizational, educational, and administrative responsibility for the laboratories’ drug testing facilities.
(2) This individual shall have documented scientific qualifications in analytical forensic toxicology. Minimum qualifications are:
(i) Certification as a laboratory director by the appropriate State in forensic or clinical laboratory toxicology; or
(ii) A Ph.D. in one of the natural sciences with an adequate undergraduate and graduate education in biology, chemistry, and pharmacology or toxicology, or
(iii) Training and experience comparable to a Ph.D. in one of the natural sciences, such as a medical or scientific degree with additional training and laboratory/research experience in biology, chemistry, and pharmacology or toxicology, and
(iv) In addition to the requirements in (i), (ii), and (iii) above, minimum qualifications also require:
(A) Appropriate experience in analytical forensic toxicology including experience with the analysis of biological material for drugs of abuse; and
(B) Appropriate training and/or experience in forensic applications of analytical toxicology, e.g., publications, court testimony, research concerning analytical toxicology of drugs of abuse, or other factors which qualify the individual as an expert witness in forensic toxicology.
(3) This individual shall be engaged in and responsible for the day-to-day management of the testing laboratory even where another individual has overall responsibility for an entire multispecialty laboratory.
(4) This individual shall be responsible for ensuring that there are enough personnel with adequate training and experience to supervise and conduct the work of their testing laboratories. He or she shall assure the continued competency of laboratory personnel by documenting their inservice training, reviewing their work performance, and verifying their skills.
(5) This individual shall be responsible for the laboratory's having a procedure manual which is complete, up-to-date, available for personnel performing tests, and followed by those personnel. The procedure manual shall be reviewed, signed, and dated by this responsible individual whenever procedures are first placed into use or changed or when a new individual assumes responsibility for management of the laboratory. Copies of all procedures and dates on which they are in effect shall be maintained. (Specific contents of the procedure manual are described in Section 2.7(0) of this appendix).
(6) This individual shall be responsible for maintaining a quality assurance program to assure the proper performance and reporting of all test results; for maintaining acceptable analytical performance for all controls and standards; for maintaining quality control testing; and for assuring and documenting the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(7) This individual shall be responsible for taking all remedial actions necessary to maintain satisfactory operation and performance of the laboratory in response to quality control systems not being within performance specifications, errors in result reporting or in analysis of performance testing results. This individual shall ensure that test results are not reported until all corrective actions have been taken and he or she can assure that the test results provided are accurate and reliable.
(b) “Test Validation.” The laboratory's urine drug testing facility shall have a qualified individual(s) who reviews all pertinent data and quality control results in order to attest to the validity of the laboratory's test reports. A laboratory may designate more than one person to perform this function. This individual(s) may be any employee who is qualified to be responsible for day-to-day management or operation of the drug testing laboratory.
(c) “Day-to-Day Operations and Supervision of Analysts.” The laboratory's urine drug testing facility shall have an individual to be responsible for day-to-day operations and to supervise the technical analysts. This individual(s) shall have at least a bachelor's degree in the chemical or biological sciences or medical technology or equivalent. He or she shall have training and experience in the theory and practice of the procedures used in the laboratory, resulting in his or her thorough understanding of quality control practices and procedures; the review, interpretation, and reporting of test results; maintenance of chain-of-custody; and proper remedial actions to be taken in response to test systems being out of control limits or detecting aberrant test or quality control results.
(d) “Other Personnel.” Other technicians or nontechnical staff shall have the necessary training and skills for the tasks assigned.
(e) “Training.” The laboratory's testing program shall make available continuing education programs to meet the needs of laboratory personnel.
(f) “Files.” Laboratory personnel files shall include: résumé of training and experience; certification or license, if any; references; job descriptions; records of performance evaluation and advancement; incident reports; and results of tests which establish employee competency for the position he or she holds, such as a test for color blindness, if appropriate.
(a) “Day-to-Day Management of Operations.” Any licensee testing facility shall have an individual to be responsible for day-to-day operations and to supervise the testing technicians. This individual(s) shall have at least a bachelor's degree in the chemical or biological sciences or medical technology or equivalent. He or she shall have training and experience in the theory and practice of the procedures used in the licensee testing facility, resulting in his or her thorough understanding of quality control practices and procedures; the review, interpretation, and reporting of test results; and proper remedial actions to be taken in response to detecting aberrant test or quality control results.
(b) “Other Personnel.” Other technicians or nontechnical staff shall have the necessary training and skills for the tasks assigned.
(c) “Files.” Licensees’ testing facility personnel files shall include: résumé of training and experience; certification or license, if any; references; job descriptions; records of performance evaluation and advancement; incident reports; results of tests which establish employee competency for the position he or she holds, such as a test for color blindness, if appropriate and appropriate data to support determinations of honesty and integrity conducted in accordance with Section 2.3 of this appendix.
(a) “Security and Chain-of-Custody.”
(1) HHS-certified drug testing laboratories and any licensee testing facility shall be secure at all times. They shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle specimens or gain access to the laboratory processes or to areas where records and split samples are stored. Access to these secured areas shall be limited to specifically authorized individuals whose authorization is documented. All authorized visitors and maintenance and service personnel shall be escorted at all times in the HHS-certified laboratory and in the licensee's testing facility. Documentation of individuals accessing these areas, dates, and times of entry and purpose of entry must be maintained.
(2) Laboratories and testing facilities shall use chain-of-custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results, during storage, and continuing until final disposition of specimens. The date and purpose shall be documented on an appropriate chain-of-custody form each time a specimen is handled or transferred, and every individual in the chain shall be identified. Accordingly, authorized technicians shall be responsible for each urine specimen or aliquot in their possession and shall sign and complete chain-of-custody forms for those specimens or aliquots as they are received.
(b) “Receiving.”
(1) When a shipment of specimens is received, laboratory and licensee's testing facility personnel shall inspect each package for evidence of possible tampering and compare information on specimen containers within each package to the information on the accompanying chain-of-custody forms. Any direct evidence of tampering or discrepancies in the information on specimen containers and the licensee's chain-of-custody forms attached to the shipment shall be reported within 24 hours to the licensee, in the case of HHS-certified laboratories, and shall
(2) Specimen containers will normally be retained within the laboratory's or testing facility's accession area until all analyses have been completed. Aliquots and the chain-of-custody forms shall be used by laboratory or testing facility personnel for conducting initial and confirmatory tests, as appropriate.
(c) “Short-Term Refrigerated Storage.” Specimens that do not receive an initial test within 7 days of arrival at the laboratory or are not shipped within 6 hours from the licensee's testing facility and any retained split samples shall be placed in secure refrigeration units. Temperatures shall not exceed 6 °C. Emergency power equipment shall be available in case of prolonged power failure.
(d) “Specimen Processing.” Urine specimens identified as presumptive positive by a licensee's testing facility shall be shipped to an HHS-certified laboratory for testing. Laboratory facilities for drug testing will normally process urine specimens by grouping them into batches. The number of specimens in each batch may vary significantly depending on the size of the laboratory and its workload. When conducting either initial or confirmatory tests at either the licensee's testing facility or an HHS-certified laboratory, every batch shall contain an appropriate number of standards for calibrating the instrumentation and a minimum of 10 percent controls. Both quality control and blind performance test samples shall appear as ordinary samples to laboratory analysts. Special processing may be conducted to analyze specimens suspected of being adulterated or diluted (including hydration). Any evidence of adulteration or dilution, and any detected trace amounts of drugs or metabolites, shall be reported to the Medical Review Officer.
(e) “Preliminary Initial Test.”
(1) For the analysis of urine specimens, any preliminary test performed by a licensee's testing facility and the initial screening test performed by a HHS-certified laboratory shall use an immunoassay which meets the requirements of the Food and Drug Administration for commercial distribution. The initial test of breath for alcohol performed at the collection site shall use a breath measurement device which meets the requirements of Section 2.7(o)(3). The following initial cut-off levels shall be used when screening specimens to determine whether they are negative for the indicated substances:
*25 ng/ml is immunoassay specific for free morphine.
In addition, licensees may specify more stringent cutoff levels. Results shall be reported for both levels in such cases.
(2) The list of substances to be tested and the cut-off levels are subject to change by the NRC in response to industry experience and changes to the HHS Guidelines made by the Department of Health and Human Services as advances in technology, additional experience, or other considerations warrant the inclusion of additional substances and other concentration levels.
(f) “Confirmatory Test.”
(1) Specimens which test negative as a result of this second screening shall be reported as negative to the licensee and will not be subject to any further testing unless special processing of the specimen is desired because adulteration or dilution is suspected.
(2) All urine samples identified as presumptive positive on the screening test performed by a HHS-certified laboratory shall be confirmed using gas chromatography/mass spectrometry -(GC/MS) techniques at the cut-off values listed in this paragraph for each drug, and at the cut-off values required by the licensee's unique program, where differences exist. All confirmations shall be by quantitative analysis. Concentrations which exceed the linear region of the standard curve shall be documented in the laboratory record as “greater than highest standard curve value.”
*Delta-9-tetrahydrocannabinol-9-carboxylic acid.
**Benzoylecgonine.
In addition, licensees may specify more stringent cut-off levels. Results shall be reported for both levels in such cases.
(3) The analytic procedure for confirmatory analysis of blood specimens voluntarily provided by individuals testing positive for alcohol on a breath test shall be gas chromatography analysis.
(4) The list of substances to be tested and the cut-off levels are subject to change by
(5) Confirmatory tests for opiates shall include a test for 6-monoacetylmorphine (MAM) if the screening test is presumptive positive for morphine.
(g) “Reporting Results.”
(1) The HHS-certified laboratory shall report test results to the licensee's Medical Review Officer within 5 working days after receipt of the specimen by the laboratory. Before any test result is reported (the results of initial tests, confirmatory tests, or quality control data), it shall be reviewed and the test certified as an accurate report by the responsible individual at the laboratory. The report shall identify the substances tested for, whether positive or negative, the cut-off(s) for each, the specimen number assigned by the licensee, and the drug testing laboratory specimen identification number. The results (positive and negative) for all specimens submitted at the same time to the laboratory shall be reported back to the Medical Review Officer at the same time when possible.
(2) The HHS-certified laboratory and any licensee testing facility shall report as negative all specimens, except suspect specimens being analyzed under special processing, which are negative on the initial test or negative on the confirmatory test. Specimens testing positive on the confirmatory analysis shall be reported positive for a specific substance. Except as provided in § 26.24(d), presumptive positive results of preliminary testing at the licensee's testing facility will not be reported to licensee management.
(3) The Medical Review Officer may routinely obtain from the HHS-certified laboratory, and the laboratory shall provide, quantitation of test results. The Medical Review Officer may only disclose quantitation of test results for an individual to licensee management, if required in an appeals process, or to the individual under the provisions of Section 3.2. (This does not preclude the provision of program performance data under the provisions of 10 CFR 26.71(d).) Quantitation of negative tests for urine specimens shall not be disclosed, except where deemed appropriate by the Medical Review Officer for proper disposition of the results of tests of suspect specimens. Alcohol quantitation for a blood specimen shall be provided to licensee management with the Medical Review Officer's evaluation.
(4) The laboratory may transmit results to the Medical Review Officer by various electronic means (e.g., teleprinters, facsimile, or computer) in a manner designed to ensure confidentiality of the information. Results may not be provided verbally by telephone from HHS-certified laboratory personnel to the Medical Review Officer. The HHS-certified laboratory must ensure the security of the data transmission and limit access to any data transmission, storage, and retrieval system.
(5) The laboratory shall send only to the Medical Review Officer a certified copy of the original chain-of-custody form signed by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports and attached to which shall be a copy of the test report.
(6) The HHS-certified laboratory and the licensee's testing facility shall provide to the licensee official responsible for coordination of the fitness-for-duty program a monthly statistical summary of urinalysis and blood testing and shall not include in the summary any personal identifying information. Initial test data from the licensee's testing facility and the HHS-certified laboratory, and confirmation data from HHS-certified laboratories shall be included for test results reported within that month. Normally this summary shall be forwarded from HHS-certified laboratories by registered or certified mail and from the licensee's testing facility not more than 14 calendar days after the end of the month covered by the summary. The summary shall contain the following information:
(i) Initial Testing:
(A) Number of specimens received;
(B) Number of specimens reported out; and
(C) Number of specimens screened positive for:
(ii) Confirmatory Testing:
(A) Number of specimens received for confirmation;
(B) Number of specimens confirmed positive for:
(7) The statistics shall be presented for both the cut-off levels in these guidelines and any more stringent cut-off levels which licensees may specify. The HHS-certified laboratory and the licensee's testing facility shall make available quantitative results for all samples tested when requested by the
(8) Unless otherwise instructed by the licensee in writing, all records pertaining to a given urine or blood specimen shall be retained by the HHS-certified drug testing laboratory and the licensee's testing facility for a minimum of 2 years.
(h) “Long-Term Storage.” Long-term frozen storage (−20 °C or less) ensures that positive urine specimens will be available for any necessary retest during administrative or disciplinary proceedings. Unless otherwise authorized in writing by the licensee, HHS-certified laboratories shall retain and place in properly secured long-term frozen storage for a minimum of 1 year all specimens confirmed positive. Within this 1-year period a licensee or the NRC may request the laboratory to retain the specimen for an additional period of time, but if no such request is received, the laboratory may discard the specimen after the end of 1 year, except that the laboratory shall be required to maintain any specimens under legal challenge for an indefinite period. Any split samples retained by the licensee shall be transferred into long-term storage upon determination by the Medical Review Officer that the specimen has a confirmed positive test.
(i) “Retesting Specimens.” Because some analytes deteriorate or are lost during freezing and/or storage, quantitation for a retest is not subject to a specific cut-off requirement but must provide data sufficient to confirm the presence of the drug or metabolite.
(j) “Split Samples.” Urine specimens may be split, at the licensee's discretion, into two parts at the collection site. One half of such samples (hereafter called the aliquot) shall be analyzed by the licensee's testing facility or the HHS-certified laboratory for the licensee's purposes as described in this appendix. The other half of the sample (hereafter called the split sample) may be withheld from transfer to the laboratory, sealed, and stored in a secure manner by the licensee until the aliquot has been determined to be negative or until the positive result of a screening test has been confirmed. As soon as the aliquot has tested negative, the split sample in storage may be destroyed. If the aliquot tests positive by confirmatory testing, then, at the tested individual's request, the split sample may be forwarded on that day to another HHS-certified laboratory that did not test the aliquot. The chain-of-custody and testing procedures to which the split sample is subject, shall be the same as those used to test the initial aliquot and shall meet the standards for retesting specimens [Section 2.7(i)]. The quantitative results of any second testing process shall be made available to the Medical Review Officer and to the individual tested.
(k) “Subcontracting.” HHS-certified laboratories shall not subcontract and shall perform all work with their own personnel and equipment unless otherwise authorized by the licensee. The laboratory must be capable of performing testing of the five classes of drugs (marijuana, cocaine, opiates, phencyclidine, and amphetamines) and of whole blood and confirmatory GC/MS methods specified in these guidelines.
(l) “Laboratory Facilities.”
(1) HHS-certified laboratories shall comply with applicable provisions of any State licensure requirements.
(2) HHS-certified laboratories shall have the capability, at the same laboratory premises, of performing initial tests for each drug and drug metabolite for which service is offered, and for performing confirmatory tests for alcohol and for each drug and drug metabolite for which service is offered. Any licensee testing facilities shall have the capability, at the same premises, of performing initial screening tests for each drug and drug metabolite for which testing is conducted. Breath tests for alcohol may be performed at the collection site.
(m) “Inspections.” The NRC and any licensee utilizing an HHS-certified laboratory shall reserve the right to inspect the laboratory at any time. Licensee contracts with HHS-certified laboratories for drug testing and alcohol confirmatory testing, as well as contracts for collection site services, shall permit the NRC and the licensee to conduct unannounced inspections. In addition, prior to the award of a contract, the licensee shall carry out pre-award inspections and evaluation of the procedural aspects of the laboratory's drug testing operation. The NRC shall reserve the right to inspect a licensee's testing facility at any time.
(n) “Documentation.” HHS-certified laboratories and the licensee's testing facility shall maintain and make available for at least 2 years documentation of all aspects of the testing process. This 2-year period may be extended upon written notification by the NRC or by any licensee for which laboratory services are being provided. The required documentation shall include personnel files on all individuals authorized to have access to specimens; chain-of-custody documents; quality assurance/quality control records; procedure manuals; all test data (including calibration curves and any calculations used in determining test results); reports; performance records on performance testing; performance on certification inspections; and hard copies of computer-generated data. The HHS-certified laboratory and the licensee's testing facility shall be required to maintain documents for any specimen under legal challenge for an indefinite period.
(o) “Additional Requirements for HHS-certified Laboratories and Licensee's Testing Facilities.”
(1) “Procedure manual.” Each laboratory and licensee's testing facility shall have a procedure manual which includes the principles of each test, preparation of reagents, standards and controls, calibration procedures, derivation of results, linearity of methods, sensitivity of the methods, cutoff values, mechanisms for reporting results, controls, criteria for unacceptable specimens and results, remedial actions to be taken when the test systems are outside of acceptable limits, reagents and expiration dates, and references. Copies of all procedures and dates on which they are in effect shall be maintained as part of the manual. Superseded material must be retained for three years.
(2) “Standards and controls.” HHS-certified laboratory standards shall be prepared with pure drug standards which are properly labeled as to content and concentration. The standards shall be labeled with the following dates: when received; when prepared or opened; when placed in service; and expiration date.
(3) “Instruments and equipment.”
(i) Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by gravimetric, colorimetric, or other verification procedure. Automatic pipettes and dilutors shall be checked for accuracy and reproducibility before being placed in service and checked periodically thereafter.
(ii) Alcohol breath analysis equipment shall be an evidental-grade breath alcohol analysis device of a brand and model that conforms to National Highway Traffic Safety Administration (NHTSA) standards (49 FR 48855) and to any applicable State statutes.
(iii) There shall be written procedures for instrument set-up and normal operation, a schedule for checking critical operating characteristics for all instruments, tolerance limits for acceptable function checks, and instructions for major troubleshooting and repair. Records shall be available on preventive maintenance.
(4) “Remedial actions.” There shall be written procedures for the actions to be taken when systems are out of acceptable limits or errors are detected. There shall be documentation that these procedures are followed and that all necessary corrective actions are taken. There shall also be in place systems to verify all stages of testing and reporting and documentation that these procedures are followed.
(5) “Personnel available to testify at proceedings.” The licensee's testing facility and HHS-certified laboratory shall have qualified personnel available to testify in an administrative or disciplinary proceeding against an individual when that proceeding is based on positive breath analysis or urinalysis results reported by the licensee's testing facility or the HHS-certified laboratory.
(a) “General.” HHS-certified laboratories and the licensee's testing facility shall have a quality assurance program which encompasses all aspects of the testing process including but not limited to specimen acquisition, chain-of-custody, security, reporting of results, initial and confirmatory testing, and validation of analytical procedures. Quality assurance procedures shall be designed, implemented, and reviewed to monitor the conduct of each step of the process of testing for drugs.
(b) “Licensee's Testing Facility Quality Control Requirements for Initial Tests.” Because all positive preliminary tests for drugs are forwarded to an HHS-certified laboratory for screening and confirmatory testing when appropriate, the NRC does not require licensees to assess their testing facility's false positive rates for drugs. To ensure that the rate of false negative tests is kept to the minimum that the immunoassay technology supports, licensees shall process blind performance test specimens and submit a sampling of specimens screened as negative from every test run to the HHS-certified laboratory. In addition, the manufacturer-required performance tests of the breath analysis equipment used by the licensee shall be conducted as set forth in the manufacturer's specifications.
(c) “Laboratory Quality Control Requirements for Initial Tests at HHS-Certified Laboratories.” Each analytical run of specimens to be screened shall include:
(1) Urine specimens certified to contain no drug;
(2) Urine specimens fortified with known standards; and
(3) Positive controls with the drug or metabolite at or near the threshold (cut-off).
In addition, with each batch of samples, a sufficient number of standards shall be included to ensure and document the linearity of the assay method over time in the concentration area of the cut-off. After acceptable values are obtained for the known standards, those values will be used to calculate sample data. Implementation of procedures to ensure that carryover does not contaminate the testing of an individual's specimen shall be documented. A minimum of 10 percent of all test samples shall be quality control specimens. Laboratory quality control samples, prepared from spiked urine samples of determined concentration, shall be included in the run and should appear as normal samples to laboratory analysts. One percent of each run, with a minimum of at least one sample, shall be the laboratory's own quality control samples.
(d) “Laboratory Quality Control Requirements for Confirmation Tests.” Each analytical run of specimens to be confirmed shall include:
(1) Urine specimens certified to contain no drug;
(2) Urine specimens fortified with known standards; and
(3) Positive controls with the drug or metabolite at or near the threshold (cut-off).
The linearity and precision of the method shall be periodically documented. Implementation of procedures to ensure that carryover does not contaminate the testing of an individual's specimen shall also be documented.
(e) “Licensee Blind Performance Test Procedures.”
(1) Licensees shall purchase chemical testing services only from laboratories certified by DHHS or a DHHS-recognized certification program in accordance with the HHS Guidelines. Laboratory participation is encouraged in other performance testing surveys by which the laboratory's performance is compared with peers and reference laboratories.
(2) During the initial 90-day period of any new drug testing program, each licensee shall submit blind performance test specimens to each HHS-certified laboratory it contracts within the amount of at least 50 percent of the total number of samples submitted (up to a maximum of 500 samples) and thereafter a minimum of 10 percent of all samples (to a maximum of 250) submitted per quarter.
(3) Approximately 80 percent of the blind performance test samples shall be blank (i.e., certified to contain no drug) and the remaining samples shall be positive for one or more drugs per sample in a distribution such that all the drugs to be tested are included in approximately equal frequencies of challenge. The positive samples shall be spiked only with those drugs for which the licensee is testing.
(4) The licensee shall investigate, or shall refer to DHHS for investigation, any unsatisfactory performance testing result, and based on this investigation, the laboratory shall take action to correct the cause of the unsatisfactory performance test result. A record shall be made of the investigative findings and the corrective action taken by the laboratory, and that record shall be dated and signed by the individuals responsible for the day-to-day management and operation of the HHS-certified laboratory. Then the licensee shall send the document to the NRC as a report of the unsatisfactory performance testing incident within 30 days. The NRC shall ensure notification of the finding to DHHS.
(5) Should a false positive error occur on a blind performance test specimen and the error is determined to be an administrative error (clerical, sample mixup, etc.), the licensee shall promptly notify the NRC. The licensees shall require the laboratory to take corrective action to minimize the occurrence of the particular error in the future; and, if there is reason to believe the error could have been systematic, the licensee may also require review and reanalysis of previously run specimens.
(6) Should a false positive error occur on a blind performance test specimen and the error is determined to be a technical or methodological error, the licensee shall instruct the laboratory to submit to them all quality control data from the batch of specimens which included the false positive specimen. In addition, the licensee shall require the laboratory to retest all specimens analyzed positive for that drug or metabolite from the time of final resolution of the error back to the time of the last satisfactory performance test cycle. This retesting shall be documented by a statement signed by the individual responsible for day-to-day management of the laboratory's substance testing program. The licensee and the NRC may require an on-site review of the laboratory which may be conducted unannounced during any hours of operation of the laboratory. Based on information provided by the NRC, DHHS has the option of revoking or suspending the laboratory's certification or recommending that no further action be taken if the case is one of less serious error in which corrective action has already been taken, thus reasonably assuring that the error will not occur again.
(a) “Medical Review Officer shall review results.” An essential part of the licensees' testing programs is the final review of results. A positive test result does not automatically identify a nuclear power plant worker as having used substances in violation of the NRC's regulations or the licensee's company policies. An individual with a detailed knowledge of possible alternate medical explanations is essential to the review of results. This review shall be performed by the Medical Review Officer prior to the transmission of results to licensee management officials.
(b) “Medical Review Officer—qualifications and responsibilities.” The Medical Review Officer shall be a licensed physician with knowledge of substance abuse disorders and may be a licensee or contract employee. The role of the Medical Review Officer is to review and interpret positive test results obtained through the licensee's testing program. In carrying out this responsibility, the Medical Review Officer shall examine alternate medical explanations for any positive test result (this does not include confirmation of blood alcohol levels obtained through the use of a breath alcohol anaylsis device). This action could include conducting a medical interview with the individual, review of the individual's medical history, or review of any other relevant biomedical factors. The
(c) “Positive Test Results.” Prior to making a final decision to verify a positive test result, the Medical Review Officer shall give the individual an opportunity to discuss the test result with him or her. Following verification of a positive test result, the Medical Review Officer shall, as provided in the licensee's policy, notify the applicable employee assistance program and the licensee's management official empowered to recommend or take administrative action (or the official's designated agent).
(d) “Verification for opiates; review for prescription medication.” Before the Medical Review Officer verifies a confirmed positive result and the licensee takes action for opiates, he or she shall determine that there is clinical evidence—in addition to the urine test—of unauthorized use of any opium, opiate, or opium derivative (e.g., morphine/codeine). Clinical signs of abuse include recent needle tracks or behavioral and psychological signs of acute opiate intoxication or withdrawal. This requirement does not apply if the GC/MS confirmation testing for opiates confirms the presence of 6-monoacetylmorphine. For other drugs that are commonly prescribed or commonly included in over-the-counter preparations (e.g., benzodiazepines in the first case, barbiturates in the second) and that are listed in the licensee's panel of substances to be tested, the Medical Review Officer shall also determine whether there is clinical evidence—in addition to the urine test—of unauthorized use of any of these substances or their derivatives.
(e) “Reanalysis authorized.” Should any question arise as to the accuracy or validity of a positive test result, only the Medical Review Officer is authorized to order a reanalysis of the original sample and such retests are authorized only at laboratories certified by DHHS. The Medical Review Officer shall authorize a reanalysis of the original aliquot on timely request of the individual tested, and shall also authorize an analysis of any sample stored by the licensee.
(f) “Results consistent with responsible substance use.” If the Medical Review Officer determines that there is a legitimate medical explanation for the positive test result and that use of the substance identified through testing in the manner and at the dosage prescribed does not reflect a lack of reliability and is unlikely to create on-the-job impairment, the Medical Review Officer shall report the test result to the licensee as negative.
(g) “Result scientifically insufficient.” Additionally, the Medical Review Officer, based on review of inspection reports, quality control data, multiple samples, and other pertinent results, may determine that the result is scientifically insufficient for further action and declare the test specimen negative. In this situation, the Medical Review Officer may request reanalysis of the original sample before making this decision. (The Medical Review Officer may request that reanalysis be performed by the same laboratory or, that an aliquot of the original specimen be sent for reanalysis to an alternate laboratory which is certified in accordance with the HHS Guidelines.) The licensee's testing facility and the HHS-certified laboratory shall assist in this review process as requested by the Medical Review Officer by making available the individual(s) responsible for day-to-day management of the licensee's test facility, of the HHS-certified laboratory or other individuals who are forensic toxicologists or who have equivalent forensic experience in urine drug testing, to provide specific consultation as required by the licensee. The licensee shall maintain records that summarize any negative findings based on scientific insufficiency and shall make them available to the NRC on request, but shall not include any personal identifying information in such reports.
Licensee contracts with HHS certified laboratories and procedures for the licensee's testing facility shall require that test records be maintained in confidence, as provided in 10 CFR 26.29. Records shall be maintained and used with the highest regard for individual privacy.
Any individual who is the subject of a drug or alcohol test under this part shall, upon written request, have access to any records relating to his or her tests and any records relating to the results of any relevant laboratory certification, review, or revocation-of-certification proceedings.
(a) Licensees subject to this part and their contractors shall use only laboratories certified under the DHHS “Mandatory Guidelines for Federal Workplace Drug Testing
(b) Licensees or their contractors may use only HHS-certified laboratories that agree to follow the same rigorous chemical testing, quality control, and chain-of-custody procedures when testing for more stringent cut-off levels as may be specified by licensees for the classes of drugs identified in this part, for analysis of blood specimens for alcohol, and for any other substances included in licensees’ drug panels.
Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83, Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201 as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
This part prescribes rules applicable to all persons in the United States governing domestic licensing of byproduct material under the Atomic Energy Act of 1954, as amended (68 Stat. 919), and under title II of the Energy Reorganization Act of 1974 (88 Stat. 1242), and exemptions from the domestic licensing requirements permitted by Section 81 of the Act. This part also gives notice to all persons who knowingly provide to any licensee, applicant, certificate of registration holder, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's, applicant's or certificate of registration holder's activities subject to this part, that they may be individually subject to NRC enforcement action for violation of § 30.10.
The requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In any conflict between the requirements in this part and a specific requirement in another part of the regulations in this chapter, the specific requirement governs.
Except for persons exempt as provided in this part and part 150 of this chapter, no person shall manufacture, produce, transfer, receive, acquire, own, possess, or use byproduct material except as authorized in a specific or general license issued pursuant to the regulations in this chapter.
(1) Release of the property for unrestricted use and termination of the license; or
(2) Release of the property under restricted conditions and termination of the license.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part and parts 31 through 36 and 39 by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
(a) Unless otherwise specified or covered under the regional licensing program as provided in paragraph (b) of this section, any communication or report concerning the regulations in parts 30 through 36 and 39 of this chapter and any application filed under these regulations may be submitted to the Commission as follows:
(1) By mail addressed to: Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
(2) By delivery in person to the Commission's offices to the Director, Office of Nuclear Material Safety and Safeguards at:
(i) 2120 L Street, NW., Washington, DC; or
(ii) 11545 Rockville Pike, Two White Flint North, Rockville, Maryland.
(b) The Commission has delegated to the five Regional Administrators licensing authority for selected parts of its decentralized licensing program for nuclear materials as described in paragraph (b)(1) of this section. Any communication, report, or application covered under this licensing program must be submitted as specified in paragraph (b)(2) of this section.
(1) The delegated licensing program includes authority to issue, renew, amend, cancel, modify, suspend, or revoke licenses for nuclear materials issued pursuant to 10 CFR parts 30 through 36, 39, 40, and 70 to all persons for academic, medical, and industrial uses, with the following exceptions:
(i) Activities in the fuel cycle and special nuclear material in quantities sufficient to constitute a critical mass in any room or area. This exception
(ii) Health and safety design review of sealed sources and devices and approval, for licensing purposes, of sealed sources and devices.
(iii) Processing of source material for extracting of metallic compounds (including Zirconium, Hafnium, Tantalum, Titanium, Niobium, etc.).
(iv) Distribution of products containing radioactive material to persons exempt pursuant 10 CFR 32.11 through 32.26.
(v) New uses or techniques for use of byproducts, source, or special nuclear material.
(2)
(ii)
(iii)
(iv)
(a) Discrimination by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act.
(1) The protected activities include but are not limited to:
(i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of this section or possible violations of requirements imposed under either of those statutes;
(ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer;
(iii) Requesting the Commission to institute action against his or her employer for the administration or enforcement of these requirements;
(iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text.
(v) Assisting or participating in, or is about to assist or participate in, these activities.
(2) These activities are protected even if no formal proceeding is actually initiated as a result of the employee assistance or participation.
(3) This section has no application to any employee alleging discrimination prohibited by this section who, acting without direction from his or her employer (or the employer's agent), deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as amended, or the Atomic Energy Act of 1954, as amended.
(b) Any employee who believes that he or she has been discharged or otherwise discriminated against by any person for engaging in protected activities specified in paragraph (a)(1) of this section may seek a remedy for the discharge or discrimination through an administrative proceeding in the Department of Labor. The administrative proceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Employment Standards Administration, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.
(c) A violation of paragraphs (a), (e), or (f) of this section by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant may be grounds for—
(1) Denial, revocation, or suspension of the license.
(2) Imposition of a civil penalty on the licensee or applicant.
(3) Other enforcement action.
(d) Actions taken by an employer, or others, which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee's engagement in protected activities does not automatically render him or her immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.
(e)(1) Each specific licensee, each applicant for a specific license, and each general licensee subject to part 19 shall prominently post the revision of NRC Form 3, “Notice to Employees,” referenced in 10 CFR 19.11(c).
(2) The posting of NRC Form 3 must be at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted not later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days following license termination.
(3) Copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D to part 20 of this chapter or by calling the NRC Information and Records Management Branch at (301) 415-7230.
(f) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department of Labor pursuant to section 211 of the Energy Reorganization Act of 1974, as amended, may contain any provision which would prohibit, restrict, or otherwise discourage an employee from
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0017.
(b) The approved information collection requirements contained in this part appear in §§ 30.9, 30.11, 30.15, 30.19, 30.20, 30.32, 30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, and appendices A, C, D, and E to this part.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In §§ 30.32, 30.37, and 30.38, NRC Form 313 is approved under control number 3150-0120.
(2) In § 30.36, NRC Form 314 is approved under control number 3150-0028.
(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.
(b) Each applicant or licensee shall notify the Commission of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or updating requirements.
(a) Any licensee, certificate of registration holder, applicant for a license or certificate of registration, employee of a licensee, certificate of registration holder or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or certificate of registration holder or applicant for a license or certificate of registration, who knowingly provides to any licensee, applicant, certificate holder, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's, certificate holder's or applicant's activities in this part, may not:
(1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, certificate of registration holder, or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or
(2) Deliberately submit to the NRC, a licensee, certificate of registration holder, an applicant, or a licensee's, certificate holder's or applicant's, contractor or subcontractor, information
(b) A person who violates paragraph (a)(1) or (a)(2) of this section may be subject to enforcement action in accordance with the procedures in 10 CFR part 2, subpart B.
(c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:
(1) Would cause a licensee, certificate of registration holder or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or
(2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, applicant, contractor, or subcontractor.
(a) The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part and parts 31 through 36 and 39 of this chapter as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
(b) Any licensee's activities are exempt from the requirements of this part to the extent that its activities are licensed under the requirements of part 72 of this chapter.
(c) The Department of Energy is exempt from the requirements of this part to the extent that its activities are subject to the requirements of part 60 or 63 of this chapter.
(d) Except as specifically provided in part 61 of this chapter, any licensee is exempt from the requirements of this part to the extent that its activities are subject to the requirements of part 61 of this chapter.
Except to the extent that Department facilities or activities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 are involved, any prime contractor of the Department is exempt from the requirements for a license set forth in sections 81 and 82 of the Act and from the regulations in this part to the extent that such contractor, under his prime contract with the Department manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material for:
(a) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of byproduct material to or from such site and the performance of contract services during temporary interruptions of such transportation;
(b) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or
(c) The use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel.
Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the regulations in this part and parts 31 through 36 and 39 of this chapter and the requirements for a license set forth in section 81 of the Act to the extent that they transport or store byproduct material in the regular course of carriage for another or storage incident thereto.
(a) Except as provided in paragraphs (c) and (d) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part and parts 31 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns or acquires products or materials containing byproduct material in concentrations not in excess of those listed in § 30.70.
(b) This section shall not be deemed to authorize the import of byproduct material or products containing byproduct material.
(c) A manufacturer, processor, or producer of a product or material in an agreement State is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part and parts 31, 32, 33, 34, 36 and 39 of this chapter to the extent that he transfers byproduct material contained in a product or material in concentrations not in excess of those specified in § 30.70 and introduced into the product or material by a licensee holding a specific license issued by an agreement State, the Commission, or the Atomic Energy Commission expressly authorizing such introduction. This exemption does not apply to the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
(d) No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this section or equivalent regulations of an Agreement State, except in accordance with a license issued pursuant to § 32.11 of this chapter or the general license provided in § 150.20 of this chapter.
(a) Except for persons who apply byproduct material to, or persons who incorporate byproduct material into, the following products, or persons who initially transfer for sale or distribution the following products containing byproduct material, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:
(1) Timepieces or hands or dials containing not more than the following specified quantities of byproduct material and not exceeding the following specified levels of radiation:
(i) 25 millicuries of tritium per timepiece,
(ii) 5 millicuries of tritium per hand,
(iii) 15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial),
(iv) 100 microcuries of promethium 147 per watch or 200 microcuries of promethium 147 per any other timepiece,
(v) 20 microcuries of promethium 147 per watch hand or 40 microcuries of promethium 147 per other timepiece hand,
(vi) 60 microcuries of promethium 147 per watch dial or 120 microcuries of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial),
(vii) The levels of radiation from hands and dials containing promethium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:
(A) For wrist watches, 0.1 millirad per hour at 10 centimeters from any surface,
(B) For pocket watches, 0.1 millirad per hour at 1 centimeter from any surface,
(C) For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.
(2) Lock illuminators containing not more than 15 millicuries of tritium or not more than 2 millicuries of promethium 147 installed in automobile locks. The levels of radiation from each lock illuminator containing promethium 147 will not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber.
(3) Balances of precision containing not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part.
(4) Automobile shift quadrants containing not more than 25 millicuries of tritium.
(5) Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas.
(6) Thermostat dials and pointers containing not more than 25 millicuries of tritium per thermostat.
(7) [Reserved]
(8) Electron tubes:
(i) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;
(ii) 1 microcurie of cobalt-60;
(iii) 5 microcuries of nickel-63;
(iv) 30 microcuries of krypton-85;
(v) 5 microcuries of cesium-137;
(vi) 30 microcuries of promethium-147;
(9) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of byproduct material:
(i) Each source contains no more than one exempt quantity set forth in § 30.71, Schedule B, and
(ii) Each instrument contains no more than 10 exempt quantities. For purposes of this paragraph (a)(9), an instrument's source(s) may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in § 30.71, Schedule B, provided that the sum of such fractions shall not exceed unity.
(iii) For purposes of this paragraph (a)(9), 0.05 microcurie of americium-241 is considered an exempt quantity under § 30.71, Schedule B.
(10) Spark gap irradiators containing not more than 1 microcurie of cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least 3 gallons per hour (11.4 liters per hour).
(b) Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in paragraph (a) of this section, or who desires to initially transfer for sale or distribution such products containing byproduct material, should apply for a specific license pursuant to § 32.14 of this chapter, which license states that the product may be distributed by the licensee to persons exempt from the regulations
Any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires synthetic plastic resins containing scandium-46 which are designed for sand-consolidation in oil wells, and which have been manufactured or initially transferred for sale or distribution, in accordance with a specific license issued pursuant to § 32.17 of this chapter or equivalent regulations of an agreement State. The exemption in this section does not authorize the manufacture or initial transfer for sale or distribution of any resins containing scandium-46.
(a) Except as provided in paragraphs (c) and (d) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 30 through 34, 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in individual quantities each of which does not exceed the applicable quantity set forth in § 30.71, Schedule B.
(b) Any person who possesses byproduct material received or acquired prior to September 25, 1971 under the general license then provided in § 31.4 of this chapter is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 30 through 34 of this chapter to the extent that such person possesses, uses, transfers, or owns such byproduct material.
(c) This section does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of byproduct material or the incorporation of byproduct material into products intended for commercial distribution.
(d) No person may, for purposes of commercial distribution, transfer byproduct material in the individual quantities set forth in § 30.71 Schedule B, knowing or having reason to believe that such quantities of byproduct material will be transferred to persons exempt under this section or equivalent regulations of an Agreement State, except in accordance with a license issued under § 32.18 of this chapter, which license states that the byproduct material may be transferred by the licensee to persons exempt under this section or the equivalent regulations of an Agreement State.
(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in paragraph (c) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to § 32.22 of this chapter, which license authorizes the initial transfer of the product for use under this section.
(b) Any person who desires to manufacture, process, or produce self-luminous products containing tritium,
(c) The exemption in paragraph (a) of this section does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.
(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing byproduct material, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material, in gas and aerosol detectors designed to protect life or property from fires and airborne hazards, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to § 32.26 of this chapter, which license authorizes the initial transfer of the product for use under this section.
(b) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use pursuant to paragraph (a) of this section, should apply for a license pursuant to § 32.26 of this chapter, which license states that the product may be initially transferred by the licensee to persons exempt from the regulations pursuant to paragraph (a) of this section or equivalent regulations of an Agreement State.
(a) Except as provided in paragraphs (b) and (c) of this section, any person is exempt from the requirements for a license set forth in Section 81 of the Act and from the regulations in this part and part 35 of this chapter provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 μ Ci) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for “in vivo” diagnostic use for humans.
(b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to part 35 of this chapter.
(c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to § 32.21 of this chapter.
(d) Nothing in this section relieves persons from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs.
Licenses for byproduct material are of two types: General and specific.
(a) The Commission issues a specific license to a named person who has filed an application for the license under the provisions of this part and parts 32 through 36, and 39.
(b) A general license is provided by regulation, grants authority to a person for certain activities involving byproduct material, and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. However, registration with the Commission may be required by the particular general license.
(a) A person may file an application in duplicate on NRC Form 313, “Application for Material License,” in accordance with the instructions in § 30.6 of this chapter. Information contained in previous applications, statements or reports filed with the Commission or the Atomic Energy Commission may be incorporated by reference, provided that the reference is clear and specific.
(b) The Commission may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Commission to determine whether the application should be granted or denied or whether a license should be modified or revoked.
(c) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.
(d) An application for license filed pursuant to the regulations in this part and parts 32 through 35 of this chapter will be considered also as an application for licenses authorizing other activities for which licenses are required by the Act, provided that the application specifies the additional activities for which licenses are requested and complies with regulations of the Commission as to applications for such licenses.
(e) Each application for a byproduct material license, other than a license exempted from part 170 of this chapter, shall be accompanied by the fee prescribed in § 170.31 of this chapter. No fee will be required to accompany an application for renewal or amendment of a license, except as provided in § 170.31 of this chapter.
(f) An application for a license to receive and possess byproduct material for the conduct of any activity which the Commission has determined pursuant to subpart A of part 51 of this chapter will significantly affect the quality of the environment shall be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any Environmental Report required pursuant to subpart A of part 51 of this chapter.
(g) An application for a specific license to use byproduct material in the form of a sealed source or in a device that contains the sealed source must either—
(1) Identify the source or device by manufacturer and model number as registered with the Commission under § 32.210 of this chapter or with an Agreement State; or
(2) Contain the information identified in § 32.210(c).
(h) As provided by § 30.35, certain applications for specific licenses filed under this part and parts 32 through 35 of this chapter must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning. In the case of renewal applications submitted before July 27, 1990, this submittal may follow the renewal application but must be submitted on or before July 27, 1990.
(i)(1) Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in § 30.72, “Schedule C—Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release,” must contain either:
(i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or
(ii) An emergency plan for responding to a release of radioactive material.
(2) One or more of the following factors may be used to support an evaluation submitted under paragraph (i)(1)(i) of this section:
(i) The radioactive material is physically separated so that only a portion could be involved in an accident;
(ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;
(iii) The release fraction in the respirable size range would be lower than the release fraction shown § 30.72 due to the chemical or physical form of the material;
(iv) The solubility of the radioactive material would reduce the dose received;
(v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in § 30.72;
(vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in § 30.72; or
(vii) Other factors appropriate for the specific facility.
(3) An emergency plan for responding to a release of radioactive material submitted under paragraph (i)(1)(ii) of this section must include the following information:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
(x)
(xi)
(xii)
(xiii)
(4) The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to NRC. The licensee shall provide any comments received within the 60 days to the NRC with the emergency plan.
(a) An application for a specific license will be approved if:
(1) The application is for a purpose authorized by the Act;
(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property;
(3) The applicant is qualified by training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property;
(4) The applicant satisfies any special requirements contained in parts 32 through 36 and 39; and
(5) In the case of an application for a license to receive and possess byproduct material for the conduct of any activity which the Commission determines will significantly affect the quality of the environment, the Director of Nuclear Material Safety and Safeguards or his designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess byproduct material in such plant or facility. As used in this paragraph the term “commencement of construction” means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.
(b) Upon a determination that an application meets the requirements of the Act, and the regulations of the Commission, the Commission will issue a specific license authorizing the possession and use of byproduct material (Form NRC 374, “Byproduct Material License”).
(a) Each license issued pursuant to the regulations in this part and the regulations in parts 31 through 36 and 39 of this chapter shall be subject to all the provisions of the Act, now or hereafter in effect, and to all valid rules, regulations and orders of the Commission.
(b) No license issued or granted pursuant to the regulations in this part
(c) Each person licensed by the Commission pursuant to the regulations in this part and parts 31 through 36 and 39 shall confine his possession and use of the byproduct material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the regulations in this part and parts 31 through 36 and 39 of this chapter shall carry with it the right to receive, acquire, own, and possess byproduct material. Preparation for shipment and transport of byproduct material shall be in accordance with the provisions of part 71 of this chapter.
(d) Each license issued pursuant to the regulations in this part and parts 31 through 36 and 39 shall be deemed to contain the provisions set forth in section 183b.-d., inclusive, of the Act, whether or not these provisions are expressly set forth in the license.
(e) The Commission may incorporate, in any license issued pursuant to the regulations in this part and parts 31 through 36 and 39, at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of byproduct material as it deems appropriate or necessary in order to:
(1) Promote the common defense and security;
(2) Protect health or to minimize danger to life or property;
(3) Protect restricted data;
(4) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.
(f) Licensees required to submit emergency plans by § 30.32(i) shall follow the emergency plan approved by the Commission. The licensee may change the approved without Commission approval only if the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the appropriate NRC Regional Office specified in § 30.6 and to affected offsite response organizations within six months after the change is made. Proposed changes that decrease, or potentially decrease, the effectiveness of the approved emergency plan may not be implemented without prior application to and prior approval by the Commission.
(g) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators shall test the generator eluates for molybdenum-99 breakthrough in accordance with § 35.204 of this chapter. The licensee shall record the results of each test and retain each record for three years after the record is made.
(h)(1) Each general licensee that is required to register by § 31.5(c)(13) of this chapter and each specific licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against:
(i) The licensee;
(ii) An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or
(iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.
(2) This notification must indicate:
(i) The bankruptcy court in which the petition for bankruptcy was filed; and
(ii) The date of the filing of the petition.
(a) Each applicant for a specific license authorizing the possession and
(b) Each applicant for a specific license authorizing possession and use of byproduct material of half-life greater than 120 days and in quantities specified in paragraph (d) of this section shall either—
(1) Submit a decommissioning funding plan as described in paragraph (e) of this section; or
(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (d) of this section using one of the methods described in paragraph (f) of this section. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section must be submitted to NRC before receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to NRC, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section.
(c)(1) Each holder of a specific license issued on or after July 27, 1990, which is of a type described in paragraph (a) or (b) of this section, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section.
(2) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (a) of this section shall submit, on or before July 27, 1990, a decommissioning funding plan as described in paragraph (e) of this section or a certification of financial assurance for decommissioning in an amount at least equal to $750,000 in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in any application for license renewal.
(3) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (b) of this section shall submit, on or before July 27, 1990, a decommissioning funding plan as described, in paragraph (e) of this section, or a certification of financial assurance for decommissioning in accordance with the criteria set forth in this section.
(4) Any licensee who has submitted an application before July 27, 1990, for renewal of license in accordance with § 30.37 shall provide financial assurance for decommissioning in accordance with paragraphs (a) and (b) of this section. This assurance must be submitted when this rule becomes effective November 24, 1995.
(d) Table of required amounts of financial assurance for decommissioning by quantity of material.
(e) Each decommissioning funding plan must contain a cost estimate for decommissioning and a description of
(f) Financial assurance for decommissioning must be provided by one or more of the following methods:
(1)
(2)
(i) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the Commission, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Commission within 30 days after receipt of notification of cancellation.
(ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Commission. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.
(iii) The surety method or insurance must remain in effect until the Commission has terminated the license.
(3)
(4) In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the table in paragraph (d) of this section, and indicating that funds for decommissioning will be obtained when necessary.
(5) When a government entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such government entity.
(g) Each person licensed under this part or parts 32 through 36 and 39 of this chapter shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with § 30.34(b), licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the Commission considers important to decommissioning consists of—
(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.
(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.
(3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak) or byproduct materials having only half-lives of less than 65 days, a list contained in a single document and updated every 2 years, of the following:
(i) All areas designated and formerly designated restricted areas as defined in 10 CFR 20.1003 (For requirements prior to January 1, 1994, see 10 CFR 20.3 as contained in the CFR edition revised as of January 1, 1993.);
(ii) All areas outside of restricted areas that require documentation under § 30.35(g)(1).
(iii) All areas outside of restricted areas where current and previous wastes have been buried as documented under 10 CFR 20.2108; and
(iv) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 10 CFR part 20, subpart E, or apply for approval for disposal under 10 CFR 20.2002.
(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.
(a)(1) Except as provided in paragraph (a)(2) of this section, each specific license expires at the end of the
(2) Each specific license that has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deemed to have an expiration date that is five years after the expiration date stated in the current license.
(3) The following specific licenses are not subject to, or otherwise affected by, the provisions of paragraph (a)(2) of this section:
(i) Specific licenses for which, on February 15, 1996, an evaluation or an emergency plan is required in accordance with § 30.32(i);
(ii) Specific licenses whose holders are subject to the financial assurance requirements specified in 10 CFR 30.35, and on February 15, 1996, the holders either:
(A) Have not submitted a decommissioning funding plan or certification of financial assurance for decommissioning; or
(B) Have not received written notice that the decommissioning funding plan or certification of financial assurance for decommissioning is acceptable;
(iii) Specific licenses whose holders are listed in the SDMP List published in NUREG 1444, Supplement 1 (November 1995);
(iv) Specific licenses whose issuance, amendment, or renewal, as of February 15, 1996, is not a categorical exclusion under 10 CFR 51.22(c)(14) and, therefore, need an environmental assessment or environmental impact statement pursuant to subpart A of part 51 of this chapter;
(v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before February 15, 1996;
(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before February 15, 1996, have been:
(A) Cited for a Severity Level I, II, or III violation in a Notice of Violation;
(B) Subject to an Order issued by the NRC; or
(C) Subject to a Confirmatory Action Letter issued by the NRC.
(vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under 10 CFR 30.37 of this part.
(b) Each specific license revoked by the Commission expires at the end of the day on the date of the Commission's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Commission Order.
(c) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of byproduct material until the Commission notifies the licensee in writing that the license is terminated. During this time, the licensee shall—
(1) Limit actions involving byproduct material to those related to decommissioning; and
(2) Continue to control entry to restricted areas until they are suitable for release in accordance with NRC requirements.
(d) Within 60 days of the occurrence of any of the following, consistent with the administrative directions in § 30.6, each licensee shall provide notification to the NRC in writing of such occurrence, and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in accordance with NRC requirements,
(1) The license has expired pursuant to paragraph (a) or (b) of this section; or
(2) The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with NRC requirements; or
(3) No principal activities under the license have been conducted for a period of 24 months; or
(4) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with NRC requirements.
(e) Coincident with the notification required by paragraph (d) of this section, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to § 30.35 in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to paragraph (g)(4)(v) of this section.
(1) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this rule becomes effective November 24, 1995.
(2) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Commission.
(f) The Commission may grant a request to extend the time periods established in paragraph (d) if the Commission determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to paragraph (d) of this section. The schedule for decommissioning set forth in paragraph (d) of this section may not commence until the Commission has made a determination on the request.
(g)(1) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Commission and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:
(i) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;
(ii) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;
(iii) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or
(iv) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.
(2) The Commission may approve an alternate schedule for submittal of a decommissioning plan required pursuant to paragraph (d) of this section if the Commission determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.
(3) Procedures such as those listed in paragraph (g)(1) of this section with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan.
(4) The proposed decommissioning plan for the site or separate building or outdoor area must include:
(i) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;
(ii) A description of planned decommissioning activities;
(iii) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;
(iv) A description of the planned final radiation survey; and
(v) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.
(vi) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the delay based on the criteria in paragraph (i) of this section.
(5) The proposed decommissioning plan will be approved by the Commission if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.
(h)(1) Except as provided in paragraph (i) of this section, licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of decommissioning.
(2) Except as provided in paragraph (i) of this section, when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.
(i) The Commission may approve a request for an alternative schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Commission determines that the alternative is warranted by consideration of the following:
(1) Whether it is technically feasible to complete decommissioning within the allotted 24-month period;
(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;
(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;
(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and
(5) Other site-specific factors which the Commission may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.
(j) As the final step in decommissioning, the licensee shall—
(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed NRC Form 314 or equivalent information; and
(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E. The licensee shall, as appropriate—
(i) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per 100 square centimeters—removable and fixed—for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and
(ii) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.
(k) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Commission determines that:
(1) Byproduct material has been properly disposed;
(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and
(3)(i) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E; or
(ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E.
(4) Records required by § 30.51 (d) and (f) have been received.
(a) Application for renewal of a specific license must be filed on NRC Form 313 and in accordance with § 30.32.
(b) If any licensee granted the extension described in 10 CFR 30.36(a)(2) has a currently pending renewal application for the extended license, that application will be considered withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded.
Applications for amendment of a license shall be filed on Form NRC-313 in accordance with § 30.32 and shall specify the respects in which the licensee desires its license to be amended and the grounds for the amendment.
In considering an application by a licensee to renew or amend his license the Commission will apply the applicable criteria set forth in § 30.33 and parts 32 through 36 and 39 of this chapter.
(a) No licensee shall transfer byproduct material except as authorized pursuant to this section.
(b) Except as otherwise provided in his license and subject to the provisions of paragraphs (c) and (d) of this section, any licensee may transfer byproduct material:
(1) To the Department;
(2) To the agency in any Agreement State which regulates radioactive material pursuant to an agreement under section 274 of the Act;
(3) To any person exempt from the licensing requirements of the Act and regulations in this part, to the extent permitted under such exemption;
(4) To any person in an Agreement State, subject to the jurisdiction of that State, who has been exempted from the licensing requirements and regulations of that State, to the extent permitted under such exemption;
(5) To any person authorized to receive such byproduct material under terms of a specific license or a general license or their equivalents issued by the Atomic Energy Commission, the Commission, or an Agreement State;
(6) To a person abroad pursuant to an export license issued under part 110 of this chapter; or
(7) As otherwise authorized by the Commission in writing.
(c) Before transferring byproduct material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State prior to receipt of the byproduct material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of byproduct material to be transferred.
(d) The following methods for the verification required by paragraph (c) of this section are acceptable:
(1) The transferor may have in his possession, and read, a current copy of
(2) The transferor may have in his possession a written certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date;
(3) For emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date:
(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registration; or
(5) When none of the methods of verification described in paragraphs (d)(1) to (4) of this section are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the byproduct material.
(a)
(b)
(1) An unplanned contamination event that:
(i) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;
(ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and
(iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.
(2) An event in which equipment is disabled or fails to function as designed when:
(i) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;
(ii) The equipment is required to be available and operable when it is disabled or fails to function; and
(iii) No redundant equipment is available and operable to perform the required safety function.
(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.
(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:
(i) The quantity of material involved is greater than five times the lowest annual limit on intake specified in appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and
(ii) The damage affects the integrity of the licensed material or its container.
(c) Preparation and submission of reports. Reports made by licensees in response to the requirements of this section must be made as follows:
(1) Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operations Center.
(i) The caller's name and call back telephone number;
(ii) A description of the event, including date and time;
(iii) The exact location of the event;
(iv) The isotopes, quantities, and chemical and physical form of the licensed material involved; and
(v) Any personnel radiation exposure data available.
(2) Written report. Each licensee who makes a report required by paragraph (a) or (b) of this section shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be sent to the U.S. Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555, with a copy to the appropriate NRC Regional office listed in appendix D of 10 CFR part 20. The reports must include the following:
(i) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;
(ii) The exact location of the event;
(iii) The isotopes, quantities, and chemical and physical form of the licensed material involved;
(iv) Date and time of the event;
(v) Corrective actions taken or planned and the results of any evaluations or assessments; and
(vi) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.
(3) The provisions of § 30.50 do not apply to licensees subject to the notification requirements in § 50.72. They do apply to those part 50 licensees possessing material licensed under part 30, who are not subject to the notification requirements in § 50.72.
(a) Each person who receives byproduct material pursuant to a license issued pursuant to the regulations in this part and parts 31 through 36 of this chapter shall keep records showing the receipt, transfer, and disposal of the byproduct material as follows:
(1) The licensee shall retain each record of receipt of byproduct material as long as the material is possessed and for three years following transfer or disposal of the material.
(2) The licensee who transferred the material shall retain each record of transfer for three years after each transfer unless a specific requirement in another part of the regulations in this chapter dictates otherwise.
(3) The licensee who disposed of the material shall retain each record of disposal of byproduct material until the Commission terminates each license that authorizes disposal of the material.
(b) The licensee shall retain each record that is required by the regulations in this part and parts 31 through 36 of this chapter or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, the record must be retained until the Commission terminates each license that authorizes the activity that is subject to the recordkeeping requirement.
(c)(1) Records which must be maintained pursuant to this part and parts 31 through 36 of this chapter may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations.
(2) If there is a conflict between the Commission's regulations in this part and parts 31 through 36 and 39 of this chapter, license condition, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this part and parts 31 through 36 and 39 of this chapter for such records shall apply unless the Commission, pursuant to § 30.11, has granted a specific exemption from the record retention requirements specified in the regulations in this part or parts 31 through 36 and 39 of this chapter.
(d) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the appropriate NRC Regional Office:
(1) Records of disposal of licensed material made under §§ 20.2002 (including burials authorized before January 28, 1981
(2) Records required by § 20.2103(b)(4).
(e) If licensed activities are transferred or assigned in accordance with § 30.34(b), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:
(1) Records of disposal of licensed material made under §§ 20.2002 (including burials authorized before January 28, 1981
(2) Records required by § 20.2103(b)(4).
(f) Prior to license termination, each licensee shall forward the records required by § 30.35(g) to the appropriate NRC Regional Office.
(a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect byproduct material and the premises and facilities wherein byproduct material is used or stored.
(b) Each licensee shall make available to the Commission for inspection, upon reasonable notice, records kept by him pursuant to the regulations in this chapter.
Each licensee shall perform, or permit the Commission to perform, such tests as the Commission deems appropriate or necessary for the administration of the regulations in this part and parts 31 through 36 and 39 of this chapter, including tests of:
(a) Byproduct material;
(b) Facilities wherein byproduct material is utilized or stored;
(c) Radiation detection and monitoring instruments; and
(d) Other equipment and devices used in connection with the utilization or storage of byproduct material.
(a)-(b) [Reserved]
(c) Except as specified in paragraph (d) of this section, each licensee who is authorized to possess tritium shall report promptly to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter by telephone and telegraph, mailgram, or facsimile any incident in which an attempt has been made or is believed to have been made to commit a theft or unlawful diversion of more than 10 curies of such material at any one time or more than 100
(d) The reports described in this section are not required for tritium possessed pursuant to a general license provided in part 31 of this chapter or for tritium contained in spent fuel.
(a) The terms and conditions of each license issued pursuant to the regulations in this part and parts 31 through 35 of this chapter shall be subject to amendment, revision or modification by reason of amendments to the Act, or by reason of rules, regulations and orders issued in accordance with the terms of the Act.
(b) Any license may be revoked, suspended or modified, in whole or in part, for any material false statement in the application or any statement of fact required under section 182 of the Act, or because of conditions revealed by such application or statement of fact or any report, record or inspection or other means which would warrant the Commission to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and provisions of the Act or of any rule, regulation or order of the Commission.
(c) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.
The Commission may cause the withholding or recall of byproduct material from any licensee who is not equipped to observe or fails to observe such safety standards to protect health as may be established by the Commission, or who uses such materials in violation of law or regulation of the Commission, or in a manner other than as disclosed in the application therefor or approved by the Commission.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 30 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 30 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 30.1, 30.2, 30.4, 30.5, 30.6, 30.8, 30.11, 30.12, 30.13, 30.15, 30.16, 30.31, 30.32, 30.33, 30.37, 30.38, 30.39, 30.61, 30.62, 30.63, 30.64, 30.70, 30.71, and 30.72.
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the parent company passes a financial test. This appendix establishes criteria for passing the financial test and for obtaining the parent company guarantee.
A. To pass the financial test, the parent company must meet the criteria of either paragraph A.1 or A.2 of this section:
1. The parent company must have:
(i) Two of the following three ratios: A ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and a ratio of current assets to current liabilities greater than 1.5; and
(ii) Net working capital and tangible net worth each at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used), or, for a power reactor licensee, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof (Tangible net worth shall be calculated to exclude the net book value of the nuclear unit(s)); and
(iii) Tangible net worth of at least $10 million; and
(iv) Assets located in the United States amounting to at least 90 percent of the total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used), or, for a power reactor licensee, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof.
2. The parent company must have:
(i) A current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poor's or Aaa, Aa, A, or Baa as issued by Moody's; and
(ii) Tangible net worth each at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used), or, for a power reactor licensee, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof (Tangible net worth shall be calculated to exclude the net book value of the nuclear unit(s)); and
(iii) Tangible net worth of at least $10 million; and
(iv) Assets located in the United States amounting to at least 90 percent of the total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used), or, for a power reactor licensee, at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all reactor units or parts thereof.
B. The parent company's independent certified public accountant must have compared the data used by the parent company in the financial test, which is derived from the independently audited, year end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure the licensee shall inform NRC within 90 days of any matters coming to the auditor's attention which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.
C. 1. After the initial financial test, the parent company must repeat the passage of the test within 90 days after the close of each succeeding fiscal year.
2. If the parent company no longer meets the requirements of paragraph A of this section, the licensee must send notice to the Commission of intent to establish alternate financial assurance as specified in the Commission's regulations. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year end financial data show that the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.
The terms of a parent company guarantee which an applicant or licensee obtains must provide that:
A. The parent company guarantee will remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the Commission. Cancellation may not occur, however, during the 120 days
B. If the licensee fails to provide alternate financial assurance as specified in the Commission's regulations within 90 days after receipt by the licensee and Commission of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor will provide such alternative financial assurance in the name of the licensee.
C. The parent company guarantee and financial test provisions must remain in effect until the Commission has terminated the license.
D. If a trust is established for decommissioning costs, the trustee and trust must be acceptable to the Commission. An acceptable trustee includes an appropriate State or Federal Government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.
For purposes of § 20.303, where there is involved a combination of isotopes in known amounts, the limit for the combination should be derived as follows: Determine, for each isotope in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific isotope when not in combination. The sum of such ratios for all the isotopes in the combination may not exceed “1” (i.e., “unity”).
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix. This appendix establishes criteria for passing the financial test for the self guarantee and establishes the terms for a self-guarantee.
A. To pass the financial test, a company must meet all of the following criteria:
(1) Tangible net worth at least 10 times the total current decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used), or, for a power reactor licensee, at least 10 times the amount of decommissioning funds being assured by a self guarantee, for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor for the total of all reactor units or parts thereof (Tangible net worth shall be calculated to exclude the net book value of the nuclear unit(s)).
(2) Assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used), or, for a power reactor licensee, at least 10 times the amount of decommissioning funds being assured by a self guarantee, for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor for the total of all reactor units or parts thereof.
(3) A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys.
B. To pass the financial test, a company must meet all of the following additional requirements:
(1) The company must have at least one class of equity securities registered under the Securities Exchange Act of 1934.
(2) The company's independent certified public accountant must have compared the data used by the company in the financial test which is derived from the independently audited, yearend financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform NRC within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.
(3) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.
C. If the licensee no longer meets the requirements of Section II.A. of this appendix, the licensee must send immediate notice to the Commission of its intent to establish alternate financial assurance as specified in the Commission's regulations within 120 days of such notice.
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
A. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Commission. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Commission, as evidenced by the return receipt.
B. The licensee shall provide alternative financial assurance as specified in the Commission's regulations within 90 days following receipt by the Commission of a notice of cancellation of the guarantee.
C. The guarantee and financial test provisions must remain in effect until the Commission has terminated the license or until another financial assurance method acceptable to the Commission has been put in effect by the licensee.
D. The licensee will promptly forward to the Commission and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of section 13 of the Securities and Exchange Act of 1934.
E. If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of “A” or above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to the Commission within 20 days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the licensee no longer meets the requirements of Section II.A. of this appendix.
F. The applicant or licensee must provide to the Commission a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Commission, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix. This appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.
A. To pass the financial test a company must meet the following criteria:
(1) Tangible net worth greater than $10 million, or at least 10 times the total current decommissioning cost estimate (or the current amount required if certification is
(2) Assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.
(3) A ratio of cash flow divided by total liabilities greater than 0.15 and a ratio of total liabilities divided by net worth less than 1.5.
B. In addition, to pass the financial test, a company must meet all of the following requirements:
(1) The company's independent certified public accountant must have compared the data used by the company in the financial test, which is required to be derived from the independently audited year end financial statement based on United States generally accepted accounting practices for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform NRC within 90 days of any matters that may cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.
(2) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.
(3) If the licensee no longer meets the requirements of paragraph II.A of this appendix, the licensee must send notice to the NRC of intent to establish alternative financial assurance as specified in NRC regulations. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year end financial data show that the licensee no longer meets the financial test requirements. The licensee must provide alternative financial assurance within 120 days after the end of such fiscal year.
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
A. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the NRC. Cancellation may not occur until an alternative financial assurance mechanism is in place.
B. The licensee shall provide alternative financial assurance as specified in the regulations within 90 days following receipt by the NRC of a notice of cancellation of the guarantee.
C. The guarantee and financial test provisions must remain in effect until the Commission has terminated the license or until another financial assurance method acceptable to the Commission has been put in effect by the licensee.
D. The applicant or licensee must provide to the Commission a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Commission, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the applicant or licensee passes the financial test of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix. This appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.
A. For colleges and universities, to pass the financial test a college or university must meet either the criteria in Paragraph II.A.(1) or the criteria in Paragraph II.A.(2) of this appendix.
(1) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys.
(2) For applicants or licensees that do not issue bonds, unrestricted endowment consisting of assets located in the United States of at least $50 million, or at least 30 times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all decommissioning activities for which the college or university is responsible as a self-guaranteeing licensee.
B. For hospitals, to pass the financial test a hospital must meet either the criteria in Paragraph II.B.(1) or the criteria in Paragraph II.B.(2) of this appendix:
(1) For applicants or licensees that issue bonds, a current rating for its most recent
(2) For applicants or licensees that do not issue bonds, all the following tests must be met:
(a) (Total Revenues less total expenditures) divided by total revenues must be equal to or greater than 0.04.
(b) Long term debt divided by net fixed assets must be less than or equal to 0.67.
(c) (Current assets and depreciation fund) divided by current liabilities must be greater than or equal to 2.55.
(d) Operating revenues must be at least 100 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the hospital is responsible as a self-guaranteeing license.
C. In addition, to pass the financial test, a licensee must meet all the following requirements:
(1) The licensee's independent certified public accountant must have compared the data used by the licensee in the financial test, which is required to be derived from the independently audited year end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform NRC within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the licensee no longer passes the test.
(2) After the initial financial test, the licensee must repeat passage of the test within 90 days after the close of each succeeding fiscal year.
(3) If the licensee no longer meets the requirements of Section I of this appendix, the licensee must send notice to the NRC of its intent to establish alternative financial assurance as specified in NRC regulations. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year end financial data show that the licensee no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.
The terms of a self-guarantee which an applicant or licensee furnishes must provide that—
A. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, and/or return receipt requested, to the Commission. Cancellation may not occur unless an alternative financial assurance mechanism is in place.
B. The licensee shall provide alternative financial assurance as specified in the Commission's regulations within 90 days following receipt by the Commission of a notice of cancellation of the guarantee.
C. The guarantee and financial test provisions must remain in effect until the Commission has terminated the license or until another financial assurance method acceptable to the Commission has been put in effect by the licensee.
D. The applicant or licensee must provide to the Commission a written guarantee (a written commitment by a corporate officer or officer of the institution) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Commission, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.
E. If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of “A” or above by either Standard and Poors or Moodys, the licensee shall provide notice in writing of such fact to the Commission within 20 days after publication of the change by the rating service.
Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).
Section 31.6 also issued under sec. 274, 73 Stat. 688 (42 U.S.C. 2021).
This part establishes general licenses for the possession and use of byproduct material and a general license for ownership of byproduct material. Specific provisions of 10 CFR Part 30 are applicable to general licenses established by this part. These provisions are specified in § 31.2 or in the particular general license.
The general licenses provided in this part are subject to the general provisions of Part 30 of this chapter (§§ 30.1 through 30.10), the provisions of §§ 30.14(d), 30.34(a) to (e), 30.41, 30.50 to 30.53, 30.61 to 30.63, and Parts 19, 20, and 21, of this chapter
A general license is hereby issued to transfer, receive, acquire, own, possess and use byproduct material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with the specifications contained in a specific license issued to him by the Commission.
(a)
(b)-(c) [Reserved]
(d)
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0016.
(b) The approved information collection requirements contained in this part appear in §§ 31.5, 31.8, and 31.11.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In § 31.11. NRC Form 483 is approved under control number 3150-0038.
(2) [Reserved]
(a) A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and Federal, State or local government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of paragraphs (b), (c) and (d) of this section, byproduct material contained in devices designed and manufactured for the purpose of detecting, measuring,
(b)(1) The general license in paragraph (a) of this section applies only to byproduct material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in—
(i) A specific license issued under § 32.51 of this chapter; or
(ii) An equivalent specific license issued by an Agreement State.
(2) The devices must have been received from one of the specific licensees described in paragraph (b)(1) of this section or through a transfer made under paragraph (c)(9) of this section.
(c) Any person who acquires, receives, possesses, uses or transfers byproduct material in a device pursuant to the general license in paragraph (a) of this section:
(1) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels;
(2) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:
(i) Devices containing only krypton need not be tested for leakage of radioactive material, and
(ii) Devices containing only tritium or not more than 100 microcuries of other beta and/or gamma emitting material or 10 microcuries of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;
(3) Shall assure that the tests required by paragraph (c)(2) of this section and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:
(i) In accordance with the instructions provided by the labels; or
(ii) By a person holding a specific license pursuant to parts 30 and 32 of this chapter or from an Agreement State to perform such activities;
(4) Shall maintain records showing compliance with the requirements of paragraphs (c)(2) and (c)(3) of this section. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:
(i) Each record of a test for leakage or radioactive material required by paragraph (c)(2) of this section must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.
(ii) Each record of a test of the on-off mechanism and indicator required by paragraph (c)(2) of this section must be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.
(iii) Each record that is required by paragraph (c)(3) of this section must be retained for three years from the date of the recorded event or until the device is transferred or disposed of.
(5) Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 185 bequerel (0.005 microcurie) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under parts 30 and 32 of this chapter or by an Agreement State. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the byproduct material in the device or as otherwise approved by the Commission. A report containing a
(6) Shall not abandon the device containing byproduct material;
(7) Shall not export the device containing byproduct material except in accordance with part 110 of this chapter;
(8)(i) Shall transfer or dispose of the device containing byproduct material only by export as provided by paragraph (c)(7) of this section, by transfer to another general licensee as authorized in paragraph (c)(9) of this section, or to a person authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter, or part 30 of this chapter that authorizes waste collection, or equivalent regulations of an Agreement State, or as otherwise approved under paragraph (c)(8)(iii) of this section.
(ii) Shall furnish a report to the Director of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days after the transfer of a device to a specific licensee or export. The report must contain—
(A) The identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;
(B) The name, address, and license number of the person receiving the device (license number not applicable if exported); and
(C) The date of the transfer.
(iii) Shall obtain written NRC approval before transferring the device to any other specific licensee not specifically identified in paragraph (c)(8)(i) of this section.
(9) Shall transfer the device to another general licensee only if—
(i) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this section, a copy of §§ 31.2, 30.51, 20.2201, and 20.2202 of this chapter, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to the Director of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001—
(A) The manufacturer's (or initial transferor's) name;
(B) The model number and the serial number of the device transferred;
(C) The transferee's name and mailing address for the location of use; and
(D) The name, title, and phone number of the responsible individual identified by the transferee in accordance with paragraph (c)(12) of this section to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or
(ii) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.
(10) Shall comply with the provisions of §§ 20.2201, and 20.2202 of this chapter for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of parts 19, 20, and 21, of this chapter.
(11) Shall respond to written requests from the Nuclear Regulatory Commission to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by submitting a letter to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 and provide written justification as to why it cannot comply.
(12) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard.
(13)(i) Shall register, in accordance with paragraphs (c)(13)(ii) and (iii) of this section, devices containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, or 37 MBq (1 mCi) of americium-241 or any other transuranic (
(ii) If in possession of a device meeting the criteria of paragraph (c)(13)(i) of this section, shall register these devices annually with the Commission and shall pay the fee required by § 170.31 of this chapter. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Commission. The registration information must be submitted to the NRC within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of paragraph (c)(13)(i) of this section is subject to the bankruptcy notification requirement in § 30.34(h) of this chapter.
(iii) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Commission—
(A) Name and mailing address of the general licensee.
(B) Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label).
(C) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under paragraph (c)(12) of this section.
(D) Address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage.
(E) Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.
(F) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.
(iv) Persons generally licensed by an Agreement State with respect to devices meeting the criteria in paragraph (c)(13)(i) of this section are not subject to registration requirements if the devices are used in areas subject to NRC jurisdiction for a period less than 180 days in any calendar year. The Commission will not request registration information from such licensees.
(14) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the Director of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage.
(15) May not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the
(d) The general license in paragraph (a) of this section does not authorize the manufacture or import of devices containing byproduct material.
Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, install, or service a device described in § 31.5 within such Agreement State is hereby granted a general license to install and service such device in any non-Agreement State and a general license to install and service such device in offshore waters, as defined in § 150.3(f) of this chapter:
(a) [Reserved]
(b) The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the Agreement State.
(c) Such person assures that any labels required to be affixed to the device under regulations of the Agreement State which licensed manufacture of the device bear a statement that removal of the label is prohibited.
(a) A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 10 curies of tritium or 300 millicuries of promethium-147 and that each device has been manufactured, assembled or initially transferred in accordance with a license issued under the provisions of § 32.53 of this chapter or manufactured or assembled in accordance with a specific license issued by an Agreement State which authorizes manufacture or assembly of the device for distribution to persons generally licensed by the Agreement State.
(b) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this section are exempt from the requirements of parts 19, 20, and 21, of this chapter, except that they shall comply with the provisions of §§ 20.2201, and 20.2202 of this chapter.
(c) This general license does not authorize the manufacture, assembly, repair or import of luminous safety devices containing tritium or promethium-147.
(d) This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.
(e) This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.
(a) A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use and transfer, in accordance with the provisions of paragraphs (b) and (c) of this section, americium-241 in the form of calibration or reference sources:
(1) Any person in a non-Agreement State who holds a specific license issued pursuant to this chapter which authorizes him to receive, possess, use and transfer byproduct material, source material, or special nuclear material; and
(2) Any Government agency, as defined in § 30.4(g) of this chapter, which holds a specific license issued pursuant to this chapter which authorizes it to receive, possess, use and transfer byproduct material, source material, or special nuclear material.
(b) The general license in paragraph (a) of this section applies only to calibration or reference sources which
(c) The general license in paragraph (a) of this section is subject to the provisions of §§ 30.14(d), 30.34 (a) to (e), and 30.50 to 30.63 of this chapter, and to the provisions of parts 19, 20, and 21, of this chapter. In addition, persons who own, receive, acquire, possess, use and transfer one or more calibration or reference sources pursuant to this general license:
(1) Shall not possess at any one time, at any one location of storage or use, more than 5 microcuries of americium-241 in such sources:
(2) Shall not receive, possess, use or transfer such source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in the following statement:
The receipt, possession, use and transfer of this source, Model __, Serial No. __, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
(3) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license pursuant to this chapter or from an Agreement State to receive the source.
(4) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241 which might otherwise escape during storage.
(5) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
(d) This general license does not authorize the manufacture or import of calibration or reference sources containing americium-241.
(e) This general license does not authorize the export of calibration or reference sources containing americium-241.
A general license is hereby issued to own byproduct material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this paragraph is not authorized to manufacture, produce, transfer, receive, possess, use, import or export byproduct material, except as authorized in a specific license.
(a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection devices, provided each device contains not more than fifty microcuries of strontium 90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to § 32.61 of this chapter or in accordance with the specifications contained in a specific license issued to the manufacturer by an Agreement State which authorizes manufacture of the ice detection devices for distribution to persons generally licensed by the Agreement State.
(b) Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice detection devices pursuant to the general license in paragraph (a) of this section:
(1) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license pursuant to part 30 or 32 of this chapter or from an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of § 20.2001.
(2) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon;
(3) Are exempt from the requirements of parts 19, 20, and 21, of this chapter except that such persons shall comply with the provisions of §§ 20.2001, 20.2201, and 20.2202 of this chapter.
(c) The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium 90 in ice detection devices.
(a) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of paragraphs (b), (c), (d), (e), and (f) of this section, the following byproduct materials in prepackaged units:
(1) Iodine-125, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.
(2) Iodine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.
(3) Carbon-14, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.
(4) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.
(5) Iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings, or animals.
(6) Selenium-75, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.
(7) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.
(b) A person shall not receive, acquire, possess, use, or transfer byproduct material under the general license established by paragraph (a) of this section unless that person:
(1) Has filed Form NRC-483, “Registration Certificate—In Vitro Testing with Byproduct Material Under General License,” with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555 and received from the Commission a validated copy of Form NRC-483 with a registration number assigned; or
(2) Has a license that authorizes the medical use of byproduct material that was issued under part 35 of this chapter.
(c) A person who receives, acquires, possesses, or uses byproduct material
(1) The general licensee shall not possess at any one time, pursuant to the general license in paragraph (a) of this section, at any one location of storage or use, a total amount of iodine 125, iodine 131, selenium-75, and/or iron-59 in excess of 200 microcuries.
(2) The general licensee shall store the byproduct material, until used, in the original shipping container or in a container providing equivalent radiation protection.
(3) The general licensee shall use the byproduct material only for the uses authorized by paragraph (a) of this section.
(4) The general licensee shall not transfer the byproduct material except by transfer to a person authorized to receive it by a license pursuant to this chapter or from an Agreement State, nor transfer the byproduct material in any manner other than in the unopened, labeled shipping container as received from the supplier.
(5) The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in paragraph (a)(7) of this section as required by § 20.2001.
(d) The general licensee shall not receive, acquire, possess, or use byproduct material pursuant to paragraph (a) of this section:
(1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of § 32.71 of this chapter or in accordance with the provisions of a specific license issued by an Agreement State that authorizes manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, or Mock Iodine-125 for distribution to persons generally licensed by the Agreement State.
(2) Unless the following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.
(e) The registrant possessing or using byproduct materials under the general license of paragraph (a) of this section shall report in writing to the Director of Nuclear Material Safety and Safeguards, any changes in the information furnished by him in the “Registration Certificate—In Vitro Testing With Byproduct Material Under General License”. Form NRC-483. The report shall be furnished within 30 days after the effective date of such change.
(f) Any person using byproduct material pursuant to the general license of paragraph (a) of this section is exempt from the requirements of parts 19, 20, and 21, of this chapter with respect to byproduct materials covered by that general license, except that such persons using the Mock Iodine-125 described in paragraph (a)(7) of this section shall comply with the provisions of §§ 20.2001, 20.2201, and 20.2202.
Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as letters, stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 31 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 31 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 31.1, 31.2, 31.3, 31.4, 31.9, 31.13, and 31.14.
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
(a) This part prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing byproduct material for sale or distribution to:
(1) Persons exempted from the licensing requirements of part 30 of this chapter, or
(2) Persons generally licensed under part 31 or 35 of this chapter.
(b) The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of part 30 of this chapter apply to applications, licenses and certificates of registration subject to this part.
As used in this part:
(a)
(b)
Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy of a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0001.
(b) The approved information collection requirements contained in this part appear in §§ 32.11, 32.12, 32.14, 32.15, 32.16, 32.17, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, and 32.210.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In § 32.11, NRC Form 313 is approved under control number 3150-0120.
(2) [Reserved]
An application for a specific license on Form NRC-313 authorizing the introduction of byproduct material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the byproduct material will be approved if the applicant:
(a) Satisfies the general requirements specified in § 30.33 of this chapter;
(b) Provides a description of the product or material into which the byproduct material will be introduced, intended use of the byproduct material and the product or material into which it is introduced, method of introduction, initial concentration of the byproduct material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioisotopes in the product or material at the time of transfer; and
(c) Provides reasonable assurance that the concentrations of byproduct material at the time of transfer will not exceed the concentrations in § 30.70 of this chapter, that reconcentration of the byproduct material in concentrations exceeding those in § 30.70 is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
(a) Each person licensed under § 32.11 shall maintain records of transfer of material and file a report with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, with a copy to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter.
(b) The report must identify the:
(1) Type and quantity of each product or material into which byproduct material has been introduced during the reporting period;
(2) Name and address of the person who owned or possessed the product or material, into which byproduct material has been introduced, at the time of introduction;
(3) The type and quantity of radionuclide introduced into each product or material; and
(4) The initial concentrations of the radionuclide in the product or material at time of transfer of the byproduct material by the licensee.
(c) The licensee shall file the report within 30 days following:
(1) Five years after filing the preceding report; or
(2) Filing an application for renewal of the license under § 30.37; or
(3) Notifying the Commission under § 30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under § 32.11.
(d) The report must cover the period between the filing of the preceding report and the occurrence specified in paragraphs (c) (1), (2), or (3) of this section. If no transfers of byproduct material have been made under § 32.11 during the reporting period, the report shall so indicate.
(e) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission.
No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under § 30.14 of this chapter or equivalent regulations of an Agreement State, except in accordance with a license issued pursuant to § 32.11 or the general license provided in § 150.20 of this chapter.
An application for a specific license to apply byproduct material to, or to incorporate byproduct material into, the products specified in § 30.15 of this chapter or to initially transfer for sale or distribution such products containing byproduct material for use pursuant to § 30.15 of this chapter will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;
(b) The applicant submits sufficient information regarding the product pertinent to evaluation of the potential radiation exposure, including:
(1) Chemical and physical form and maximum quantity of byproduct material in each product;
(2) Details of construction and design of each product;
(3) The method of containment or binding of the byproduct material in the product;
(4) Procedures for and results of prototype testing to demonstrate that the material will not become detached from the product and that the byproduct material will not be released to the environment under the most severe conditions likely to be encountered in normal use of the product;
(5) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet;
(6) The proposed method of labeling or marking each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container with the identification of the manufacturer or initial transferor of the product and the byproduct material in the product;
(7) For products for which limits on levels of radiation are specified in § 30.15 of this chapter, the radiation level and the method of measurement;
(8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the product.
(c) Each product will contain no more than the quantity of byproduct material specified for that product in § 30.15 of this chapter. The levels of radiation from each product containing byproduct material will not exceed the limits specified for that product in § 30.15 of this chapter.
(d) The Commission determines that:
(1) The byproduct material is properly contained in the product under the most severe conditions that are likely to be encountered in normal use and handling.
(2) For automobile lock illuminators, the product has been subjected to and meets the requirements of the prototype tests prescribed by § 32.40, schedule A.
(a) Each person licensed under § 32.14 shall:
(1) Maintain quality assurance practices in the manufacture of the part or product, or the installation of the part into the product;
(2) Subject inspection lots to such testing as may be required as a condition of the license issued under § 32.14 taking a random sample of the size required by the tables in § 32.110, and for Lot Tolerance Percent Defective of 5.0 percent, accept or reject inspection lots in accordance with the directions of § 32.110; and
(3) Visually inspect each unit, except electron tubes containing byproduct material, in inspection lots. Any unit which has an observable physical defect that could affect containment of the byproduct material shall be considered as a defective unit.
(b) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (a)(2) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that the operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk of 0.10.
(c) No person licensed under § 32.14 shall transfer to other persons for use under § 30.15 of this chapter or equivalent regulations of an Agreement State:
(1) Any part or product which has been tested and found defective under the criteria and procedures specified in the license issued under § 32.14, unless the defective units have been repaired or reworked and have then met such
(2) Any inspection lot which has been rejected as a result of the procedures in § 32.110 or alternative procedures in paragraph (b) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met such criteria as may be required as a condition of the license issued under § 32.14.
(d) Label or mark each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container so that the manufacturer or initial transferor of the product and the byproduct material in the product can be identified.
(a) Each person licensed under § 32.14 or § 32.17 shall maintain records of transfer of material and report to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, with a copy to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter.
(b) The report must include the following information on items transferred to other persons for use under § 30.15 or § 30.16 of this chapter or equivalent regulations of an Agreement State:
(1) A description or identification of the type of each product;
(2) For each radionuclide in each type of product, the total quantity of the radionuclide; and
(3) The number of units of each type of product transferred during the reporting period.
(c) The licensee shall file the report within 30 days after:
(1) Five years after filing the preceding report; or
(2) Filing an application for renewal of the license under § 30.37; or
(3) Notifying the Commission under § 30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under § 32.14 or § 32.17.
(d) The report must cover the period between the filing of the preceding report and the occurrence specified in paragraphs (c) (1), (2), or (3) of this section. If no transfers of byproduct material have been made under § 32.14 or § 32.17 during the reporting period, the report must so indicate.
(e) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission.
An application for a specific license to manufacture, or initially transfer for sale or distribution, synthetic plastic resins containing scandium-46 for use pursuant to § 30.16 of this chapter will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;
(b) The product is designed to be used only for sand-consolidation in oil wells;
(c) The applicant submits the following information:
(1) The general description of the product to be manufactured or initially transferred.
(2) A description of control procedures to be used to assure that the concentration of scandium-46 in the final product at the time of distribution will not exceed 1.4×10
(d) Each container of such product will bear a durable, legible lable approved by the Commission, which contains the following information:
(1) The product name;
(2) A statement that the product contains radioactive scandium and is designed and manufactured only for sand-consolidation in oil wells;
(3) Instructions necessary for proper use; and
(4) The manufacturer's name.
An application for a specific license to manufacture, process, produce, package, repackage, or transfer quantities of byproduct material for commercial distribution to persons exempt pursuant to § 30.18 of this chapter or the equivalent regulations of an Agreement State will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter:
(b) The byproduct material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;
(c) The byproduct material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and
(d) The applicant submits copies of prototype labels and brochures and the Commission approves such labels and brochures.
Each license issued under § 32.18 is subject to the following conditions:
(a) No more than 10 exempt quantities set forth in § 30.71, Schedule B of this chapter shall be sold or transferred in any single transaction. For purposes of this requirement, an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in § 30.71, Schedule B of this chapter, provided that the sum of such fractions shall not exceed unity.
(b) Each quantity of byproduct material set forth in § 30.71, Schedule B of this chapter shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to § 30.18 of this chapter. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.
(c) The immediate container of each quantity or separately packaged fractional quantity of byproduct material shall bear a durable, legible label which (1) identifies the radioisotope and the quantity of radioactivity, and (2) bears the words “Radioactive Material.”
(d) In addition to the labeling information required by paragraph (c) of this section, the label affixed to the immediate container, or an accompanying brochure, shall also (1) state that the contents are exempt from NRC or Agreement State licensing requirements; (2) bear the words “Radioactive Material—Not for Human Use—Introduction Into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or Into Products Manufactured for Commercial Distribution is Prohibited—Exempt Quantities Should Not be Combined”; and (3) set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.
(a) Each person licensed under § 32.18 of this part shall maintain records of transfer of material identifying, by name and address, each person to whom byproduct material is transferred for use under § 30.18 of this chapter or the equivalent regulations of an Agreement State and stating the kinds and quantities of byproduct material transferred. The licensee shall maintain the record of a transfer for a period of one year after the event is included in a summary report to the Commission.
(b) The licensee shall file a summary report stating the total quantity of
(c) The licensee shall file the summary report within 30 days following:
(1) Five years after filing the preceding report; or
(2) Filing an application for renewal of the license under § 30.37; or
(3) Notifying the Commission under § 30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under § 32.18.
(d) The report must cover the period between the filing of the preceding report and the occurrences specified in paragraph (c) (1), (2), or (3) of this section. If no transfers of byproduct material have been made under § 32.18 during the reporting period, the report must so indicate.
(a) An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1 μ Ci) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for “in vivo” diagnostic use, to persons exempt from licensing under § 30.21 of this chapter or the equivalent regulations of an Agreement State will be approved if:
(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter, provided that the requirements of § 30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, prepared, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State;
(2) The applicant meets the requirements under § 32.72(a)(2) of this part;
(3) The applicant provides evidence that each capsule contains 37 kBq (1 μ Ci) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process);
(4) The carbon-14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being;
(5) The carbon-14 urea is in the form of a capsule, identified as radioactive, and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and
(6) The applicant submits copies of prototype labels and brochures and the NRC approves these labels and brochures.
(b) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing drugs.
Each license issued under § 32.21 of this part is subject to the following conditions:
(a) The immediate container of the capsule(s) must bear a durable, legible label which:
(1) Identifies the radioisotope, the physical and chemical form, the quantity of radioactivity of each capsule at a specific date; and
(2) Bears the words “Radioactive Material.”
(b) In addition to the labeling information required by paragraph (a) of this section, the label affixed to the immediate container, or an accompanying brochure also must:
(1) State that the contents are exempt from NRC or Agreement State licensing requirements; and
(2) Bears the words “Radioactive Material. For “In Vivo” Diagnostic Use Only. This Material Is Not To Be Used for Research Involving Human Subjects and Must Not Be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products
(a) An application for a specific license to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to initially transfer such products for use pursuant to § 30.19 of this chapter or equivalent regulations of an Agreement State, will be approved if:
(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter:
(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the self-luminous product to demonstrate that the product will meet the safety criteria set forth in § 32.23. The information should include:
(i) A description of the product and its intended use or uses.
(ii) The type and quantity of byproduct material in each unit.
(iii) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product.
(iv) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (a)(2) (iii) and (xii) of this section.
(v) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product.
(vi) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement.
(vii) Degree of access of human beings to the product during normal handling and use.
(viii) Total quantity of byproduct material expected to be distributed in the product annually.
(ix) The expected useful life of the product.
(x) The proposed method of labeling or marking each unit with identification of the manufacturer or initial transferor of the product and the byproduct material in the product.
(xi) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product.
(xii) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features.
(xiii) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.23 and the basis for such estimates.
(xiv) A determination that the probabilities with respect to the doses referred to in § 32.23(d) meet the criteria of that paragraph.
(xv) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet.
(xvi) Any additional information, including experimental studies and tests, required by the Commission.
(b) Notwithstanding the provisions of paragraph (a) of this section, the Commission may deny an application for a specific license under this section if the end uses of the product cannot be reasonably foreseen.
An applicant for a license under § 32.22 shall demonstrate that the product is designed and will be manufactured so that:
(a) In normal use and disposal of a single exempt unit, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.24 of this part.
(b) In normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column II of the table in § 32.24.
(c) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.
(d)
Low—not more than one such failure per year for each 10,000 exempt units distributed.
Negligible—not more than one such failure per year for each 1 million exempt units distributed.
Each person licensed under § 32.22 shall:
(a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission;
(b) Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the product and the byproduct material in the product can be identified; and
(c) Maintain records and file reports with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, with copies to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter.
(1) The report must include the following information on products transferred to other persons for use under
(i) A description or identification of the type of each product;
(ii) For each radionuclide in each type of product, the total quantity of the radionuclide; and
(iii) The number of units of each type of product transferred during the reporting period.
(2) The licensee shall file the report within 30 days following:
(i) Five years after filing the preceding report; or
(ii) Filing an application for renewal of the license under § 30.37; or
(iii) Notifying the Commission under § 30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under § 32.22.
(3) The report must cover the period between the filing of the preceding report and the occurrences specified in paragraphs (c)(2)(i), (ii), or (iii) of this section. If no transfers of byproduct material have been made under § 32.22 during the reporting period, the report must so indicate.
(4) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission.
An application for a specific license to manufacture, process, or produce gas and aerosol detectors containing byproduct material and designed to protect life or property from fires and airborne hazards, or to initially transfer such products for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State, will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter:
(b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the gas and aerosol detector to demonstrate that the product will meet the safety criteria set forth in § 32.27. The information should include:
(1) A description of the product and its intended use or uses;
(2) The type and quantity of byproduct material in each unit;
(3) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product;
(4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b) (3) and (12) of this section;
(5) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product;
(6) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement;
(7) Degree of access of human beings to the product during normal handling and use;
(8) Total quantity of byproduct material expected to be distributed in the product annually;
(9) The expected useful life of the product;
(10) The proposed methods of labeling or marking the detector and its point-of-sale package to satisfy the requirements of § 32.29(b);
(11) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product;
(12) Results of the prototype testing of the product, including any change in
(13) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.27 and the basis for such estimates;
(14) A determination that the probabilities with respect to the doses referred to in § 32.27(c) meet the criteria of that paragraph;
(15) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet; and
(16) Any additional information, including experimental studies and tests, required by the Commission.
An applicant for a license under § 32.26 shall demonstrate that the product is designed and will be manufactured so that:
(a) In normal use and disposal of a single exempt unit, and in normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.28.
(b) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.
(c) In use and disposal of a single exempt unit and in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in § 32.28, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in § 32.28.
Low—not more than one such failure per year for each 10,000 exempt units distributed.
Negligible—not more than one such failure per year for each one million exempt units distributed.
Each person licensed under § 32.26 shall:
(a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission;
(b) Label or mark each detector and its point-of-sale package so that:
(1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing:
(i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”;
(ii) The name of the radionuclide and quantity of activity; and
(iii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State.
(2) The labeling or marking specified in paragraph (b)(1) of this section is located where its will be readily visible when the detector is removed from its mounting.
(3) The external surface of the point-of-sale package has a legible, readily visible label or marking containing:
(i) The name of the radionuclide and quantity of activity;
(ii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State; and
(iii) The following or a substantially similar statement:
THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.
(4) Each detector and point-of-sale package is provided with such other information as may be required by the Commission; and
(c) Maintain records and file a report with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, with copies to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter.
(1) The report must include the following information on products transfered to other persons for use under § 30.20 of this chapter or equivalent regulations of an Agreement State:
(i) A description or identification of the type of each product;
(ii) For each radionuclide in each type of product, the total quantity of the radionuclide; and
(iii) The number of units of each type of product transferred during the reporting period.
(2) The licensee shall file the report within 30 days following:
(i) Five years after filing the preceding report; or
(ii) Filing an application for renewal of the license under § 30.37; or
(iii) Notifying the Commission under § 30.34(f) of the licensee's decision to permanently discontinue activities authorized pursuant to the license issued under § 32.26.
(3) The report must cover the period between the filing of the preceding report and the occurrences specified in paragraphs (c)(2) (i), (ii), or (iii) of this section. If no transfers of byproduct material have been made under § 32.26 during the reporting period, the report must so indicate.
(4) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission.
An applicant for a license pursuant to § 32.14 to install lock illuminators into automobile locks, or to initially transfer lock illuminators in automobile locks for use pursuant to § 30.15 of this chapter shall conduct the following prototype tests on each of five prototype devices, consisting of the automobile lock with the installed illuminator in the following order:
(a) The device shall be subjected to 100 hours of accelerated weathering in a suitable weathering machine which simulates the most severe conditions of normal use;
(b) The device shall be dropped upon a concrete or iron surface in a 3-foot free gravitational fall, or shall be subjected to an equivalent treatment in a test device simulating such a fall. The drop test shall be repeated 100 times from random orientations;
(c) The device shall be attached to a vibratory fixture and vibrated at a rate of not less than 26 cycles per second and a vibration acceleration of not less
(d) On completion of the foregoing tests, the device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of water entry into the lock illuminator. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any evidence of bubbles emanating from within the lock illuminator, or water entering the lock illuminator, shall be considered leakage;
(e) After each of the tests prescribed by this section, each device shall be examined for evidence of physical damage and for loss of tritium or promethium-147. Any evidence of damage to or failure of any device which could affect the containment of the tritium or promethium-147 in such devices shall be cause for rejection of the design on which such prototype devices were constructed or manufactured if the damage or failure is attributable to design defect. Loss of tritium or promethium-147 from each tested device shall be measured both by sampling the immersion test water used in paragraph (d) of this section and by wiping with filter paper the entire accessible area of the lock illuminator. Measurements of tritium or promethium-147 shall be made in an apparatus calibrated to measure tritium or promethium-147, as appropriate. If more than 0.1 percent of the original amount of tritium or promethium-147 in the device is found in the immersion test water of the test in paragraph (d) of this section, or if more than 2,200 disintegrations per minute of tritium or promethium-147 on the filter paper is measured after any of the tests in paragraphs (a) to (d) of this section the device shall be rejected.
(a) An application for a specific license to manufacture, or initially transfer devices containing byproduct material to persons generally licensed under § 31.5 of this chapter or equivalent regulations of an Agreement State will be approved if:
(1) The applicant satisfies the general requirements of § 30.33 of this chapter;
(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:
(i) The device can be safely operated by persons not having training in radiological protection;
(ii) Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in 1 year a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter; and
(iii) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in § 32.24.
(3) Each device bears a durable, legible, clearly visible label or labels approved by the Commission which contain in a clearly identified and separate statement:
(i) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);
(ii) The requirements, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and
(iii) The information called for in the following statement in the same or substantially similar form:
The receipt, possession, use, and transfer of this device Model ____
(4) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, “Caution-Radioactive Material,” the radiation symbol described in § 20.1901 of this chapter, and the name of the manufacturer or initial distributor.
(5) Each device meeting the criteria of § 31.5(c)(13)(i) of this chapter, bears a permanent (
(b) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, he shall include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Commission will consider information which includes, but is not limited to:
(1) Primary containment (source capsule);
(2) Protection of primary containment;
(3) Method of sealing containment;
(4) Containment construction materials;
(5) Form of contained radioactive material;
(6) Maximum temperature withstood during prototype tests;
(7) Maximum pressure withstood during prototype tests;
(8) Maximum quantity of contained radioactive material;
(9) Radiotoxicity of contained radioactive material; and
(10) Operating experience with identical devices or similarly designed and constructed devices.
(c) In the event the applicant desires that the general licensee under § 31.5 of this chapter, or under equivalent regulations of an Agreement State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the bases for these estimates. The submitted information must demonstrate that performance of this activity or activities by an individual untrained in radiological protection, in addition to
(a) If a device containing byproduct material is to be transferred for use under the general license contained in § 31.5 of this chapter, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes—
(1) A copy of the general license contained in § 31.5 of this chapter; if paragraphs (c)(2) through (4) or (c)(13) of § 31.5 do not apply to the particular device, those paragraphs may be omitted.
(2) A copy of §§ 31.2, 30.51, 20.2201, and 20.2202 of this chapter;
(3) A list of the services that can only be performed by a specific licensee;
(4) Information on acceptable disposal options including estimated costs of disposal; and
(5) An indication that NRC's policy is to issue high civil penalties for improper disposal.
(b) If byproduct material is to be transferred in a device for use under an equivalent general license of an Agreement State, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes—
(1) A copy of the Agreement State's regulations equivalent to §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a copy of §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter. If a copy of the NRC regulations is provided to a prospective general licensee in lieu of the Agreement State's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted.
(2) A list of the services that can only be performed by a specific licensee;
(3) Information on acceptable disposal options including estimated costs of disposal; and
(4) The name or title, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.
(c) An alternative approach to informing customers may be proposed by the licensee for approval by the Commission.
(d) Each device that is transferred after February 19, 2002 must meet the labeling requirements in § 32.51(a)(3) through (5).
(e) If a notification of bankruptcy has been made under § 30.34(h) or the license is to be terminated, each person licensed under § 32.51 shall provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under § 32.52(c).
Each person licensed under § 32.51 to initially transfer devices to generally licensed persons shall comply with the requirements of this section.
(a) The person shall report all transfers of devices to persons for use under the general license in § 31.5 of this chapter and all receipts of devices from persons licensed under § 31.5 to the Director of the Office of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The report must be submitted on a quarterly basis
(1) The required information for transfers to general licensees includes—
(i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.
(ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;
(iii) The date of transfer;
(iv) The type, model number, and serial number of the device transferred; and
(v) The quantity and type of byproduct material contained in the device.
(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).
(3) For devices received from a § 31.5 general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.
(4) If the licensee makes changes to a device possessed by a § 31.5 general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.
(5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
(6) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.
(7) If no transfers have been made to or from persons generally licensed under § 31.5 of this chapter during the reporting period, the report must so indicate.
(b) The person shall report all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.5 of this chapter and all receipts of devices from general licensees in the Agreement State's jurisdiction to the responsible Agreement State agency. The report must be submitted on Form 653—“Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form.
(1) The required information for transfers to general licensees includes—
(i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.
(ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;
(iii) The date of transfer;
(iv) The type, model number, and serial number of the device transferred; and
(v) The quantity and type of byproduct material contained in the device.
(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).
(3) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and,
(4) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.
(5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
(6) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.
(7) If no transfers have been made to or from a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon request of the agency.
(c) The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this paragraph must be maintained for a period of 3 years following the date of the recorded event.
An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under § 31.7 of this chapter, will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;
(b) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:
(1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;
(2) Details of construction and design;
(3) Details of the method of binding or containing the tritium or promethium-147;
(4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;
(5) Any quality control procedures proposed as alternatives to those prescribed by § 32.55;
(6) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device.
(c) Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber.
(d) The Commission determines that:
(1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;
(2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;
(3) The device is so designed that it cannot easily be disassembled; and
(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.101, Schedule B, of this part.
(a) A person licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under § 31.7 of this chapter shall, except as provided in paragraph (b) of this section, affix to each device a label containing the radiation symbol prescribed by § 20.1901 of
The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing ______ (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
*The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.
(b) If the Commission determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (a) of this section, it may waive the requirements of that paragraph and require in lieu thereof that:
(1) A label be affixed to the device identifying:
(i) The manufacturer, assembler, or initial transferor; and
(ii) The type of radioactive material; and
(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:
(i) The name of the manufacturer, assembler, or initial transferor,
(ii) The type and quantity of radioactive material,
(iii) The model number,
(iv) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the U.S. NRC or of an Agreement State, and
(v) Such other information as may be required by the Commission, including disposal instructions when appropriate.
(a) Each person licensed under § 32.53 shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the tritium or promethium-147.
(b) Each person licensed under § 32.53 shall take a random sample of the size required by the table in § 32.110 for Lot Tolerance Percent Defective of 5.0 percent from each inspection lot, and shall subject each unit in the sample to the following tests:
(1) Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of water entry. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks as evidenced by bubbles emanating from within the device, or water entering the device, shall be considered as a defective unit.
(2) The immersion test water from the preceding test in paragraph (b)(1) of this section shall be measured for tritium or promethium-147 content by an apparatus that has been calibrated to measure tritium or promethium-147, as appropriate. If more than 0.1 percent of the original amount of tritium or promethium-147 in any device is found to have leaked into the immersion test water, the leaking device shall be considered as a defective unit.
(3) The levels of radiation from each device containing promethium-147 shall be measured. Any device which has a radiation level in excess of 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, shall be considered as a defective unit.
(c) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (b) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that:
(1) They will consider defective any sampled device which has a leakage rate exceeding 0.1 percent of the original quantity of tritium or promethium 147 in any 24-hour period; and
(2) The operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk of 0.10.
(d) No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter:
(1) Any luminous safety device which has been tested and found defective under the criteria and procedures specified in this section, unless the defective units have been repaired or reworked and have then met the tests set out in paragraph (b) of this section; or
(2) Any inspection lot which has been rejected as a result of the procedures in § 32.110 or alternative procedures in paragraph (c) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met the tests set out in paragraph (b) of this section.
Each person licensed under § 32.53 shall file an annual report with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under § 31.7 of this chapter. The report must identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report must cover the year ending June 30 and must be filed within thirty (30) days thereafter.
An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241, for distribution to persons generally licensed under § 31.8 of this chapter, will be approved if:
(a) The applicant satisfies the general requirements of § 30.33 of this chapter;
(b) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:
(1) Chemical and physical form and maximum quantity of americium 241 in the source;
(2) Details of construction and design;
(3) Details of the method of incorporation and binding of the americium-241 in the source;
(4) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241, to demonstrate that the americium-241 contained in each source will not be released or be removed from the source under normal conditions of use;
(5) Details of quality control procedures to be followed in manufacture of the source;
(6) Description of labeling to be affixed to the source or the storage container for the source;
(7) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source.
(c) Each source will contain no more than 5 microcuries of americium-241.
(d) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium-241, that:
(1) The method of incorporation and binding of the americium-241 in the
(2) The source has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.102, Schedule C, of this part.
Each person licensed under § 32.57 shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement:
The receipt, possession, use and transfer of this source, Model __-, Serial No. __-, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
Each person licensed under § 32.57 shall perform a dry wipe test upon each source containing more than 0.1 microcurie of americium-241 prior to transferring the source to a general licensee under § 31.8 of this chapter. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detection instrumentation capable of detecting 0.005 microcurie of americium-241. If any such test discloses more than 0.005 microcurie of radioactive material, the source shall be deemed to be leaking or losing americium-241 and shall not be transferred to a general licensee under § 31.8 of this chapter.
An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under § 31.10 of this chapter will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;
(b) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:
(1) Chemical and physical form and maximum quantity of strontium-90 in the device;
(2) Details of construction and design of the source of radiation and its shielding;
(3) Radiation profile of a prototype device;
(4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;
(5) Details of quality control procedures to be followed in manufacture of the device;
(6) Description of labeling to be affixed to the device;
(7) Instructions for handling and installation of the device;
(8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device;
(c) Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;
(d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.1901(a) of this chapter, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;
(e) The Commission determines that:
(1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;
(2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;
(3) The device is so designed that it cannot be easily disassembled;
(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.103; and
(5) Quality control procedures have been established to satisfy the requirements of § 32.62.
(a) Each person licensed under § 32.61 shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.
(b) Each person licensed under § 32.61 shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.
(c) Each person licensed under § 32.61 shall take a random sample of the size required by the table in § 32.110 for Lot Tolerance Percent Defective of 5.0 percent from each inspection lot, and shall subject each unit in the sample to the following tests:
(1) Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of physical contact between the water and the strontium-90. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks, as evidenced by physical contact between the water and the strontium-90, shall be considered as a defective unit.
(2) The immersion test water from the preceding test in paragraph (c)(1) of this section shall be measured for radioactive material. If the amount of radioactive material in the immersion test water is greater than 0.1 percent of the original amount of strontium-90 in any device, the device shall be considered as a defective unit.
(d) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (c) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that:
(1) They will consider defective any sampled device which has a leakage rate exceeding 0.1 percent of the original quantity of strontium-90 in any 24-hour period; and
(2) The operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of
(e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter:
(1) Any device which has been tested and found defective under the criteria and procedures specified in this § 32.62 unless the defective units have been repaired or reworked and then met the tests set out in paragraph (c) of this section; or
(2) Any inspection lot which has been rejected as a result of the procedures in § 32.110 or alternative procedures in paragraph (d) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met the tests set out in paragraph (c) of this section.
An application for a specific license to manufacturer or distribute byproduct material for use under the general license of § 31.11 of this chapter will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter.
(b) The byproduct material is to be prepared for distribution in prepackaged units of:
(1) Iodine-125 in units not exceeding 10 microcuries each.
(2) Iodine-131 in units not exceeding 10 microcuries each.
(3) Carbon-14 in units not exceeding 10 microcuries each.
(4) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each.
(5) Iron-59 in units not exceeding 20 microcuries each.
(6) Selenium-75 in units not exceeding 10 microcuries each.
(7) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each.
(c) Each prepackaged unit bears a durable, clearly visible label:
(1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-131, iodine-125, selenium-75, or carbon-14; 50 microcuries of hydrogen-3 (tritium); or 20 microcuries of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each; and
(2) Displaying the radiation caution symbol described in § 20.1901(a) of this chapter and the words, “Caution, Radioactive Material”, and “Not for Internal or External Use in Humans or Animals.”
(d) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.
(e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such byproduct material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the
(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized pursuant to part 35 of this chapter will be approved if:
(1) The applicant satisfies the general requirements specified in 10 CFR 30.33;
(2) The applicant submits evidence that the applicant is at least one of the following:
(i) Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer;
(ii) Registered or licensed with a state agency as a drug manufacturer;
(iii) Licensed as a pharmacy by a State Board of Pharmacy; or
(iv) Operating as a nuclear pharmacy within a Federal medical institution.
(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and
(4) The applicant satisfies the following labeling requirements:
(i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.
(ii) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL” and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.
(b) A licensee described by paragraph (a)(2)(iii) or (iv) of this section:
(1) May prepare radioactive drugs for medical use, as defined in 10 CFR 35.2, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraphs (b)(2) and (b)(4) of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in 10 CFR 35.27.
(2) May allow a pharmacist to work as an authorized nuclear pharmacist if:
(i) This individual qualifies as an authorized nuclear pharmacist as defined in 10 CFR 35.2,
(ii) This individual meets the requirements specified in 10 CFR 35.55(b) or, prior to October 25, 2004, 10 CFR 35.980(b) and 35.59 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or
(iii) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (b)(4) of this section.
(3) The actions authorized in paragraphs (b)(1) and (b)(2) of this section are permitted in spite of more restrictive language in license conditions.
(4) May designate a pharmacist (as defined in 10 CFR 35.2) as an authorized nuclear pharmacist if the individual is identified as of December 2, 1994, as an “authorized user” on a nuclear pharmacy license issued by the Commission under this part.
(5) Shall provide to the Commission a copy of each individual's certification by the Board of Pharmaceutical Specialties, the Commission or Agreement State license, or the permit issued by a licensee of broad scope, and a copy of
(c) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:
(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and
(2) Check each instrument for constancy and proper operation at the beginning of each day of use.
(d) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.
(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to part 35 of this chapter for use as a calibration or reference source or for the uses listed in §§ 35.400, 35.500, and 35.600 of this chapter will be approved if:
(1) The applicant satisfies the general requirements in § 30.33 of this chapter;
(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:
(i) The byproduct material contained, its chemical and physical form, and amount;
(ii) Details of design and construction of the source or device;
(iii) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;
(iv) For devices containing byproduct material, the radiation profile of a prototype device;
(v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;
(vi) Procedures and standards for calibrating sources and devices;
(vii) Legend and methods for labeling sources and devices as to their radioactive content;
(viii) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device:
(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the U.S. Nuclear Regulatory Commission has approved distribution of the (name of source or device) to persons licensed to use byproduct material identified in §§ 35.65, 35.400, 35.500, and 35.600 as appropriate, and to persons who hold an equivalent license issued by an Agreement State. However, labels worded in accordance with requirements that were in place on March 30, 1987 may be used until March 30, 1989.
(b)(1) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he shall include in his application sufficient information to demonstrate that such longer interval
(2) In determining the acceptable interval for test of leakage of radioactive material, the Commission will consider information that includes, but is not limited to:
(i) Primary containment (source capsule);
(ii) Protection of primary containment;
(iii) Method of sealing containment;
(iv) Containment construction materials;
(v) Form of contained radioactive material;
(vi) Maximum temperature withstood during prototype tests;
(vii) Maximum pressure withstood during prototype tests;
(viii) Maximum quantity of contained radioactive material;
(ix) Radiotoxicity of contained radioactive material;
(x) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.
(c) If an application is filed pursuant to paragraph (a) of this section on or before October 15, 1974, for a license to manufacture and distribute a source or device that was distributed commercially on or before August 16, 1974, the applicant may continue the distribution of such source or device to group licensees until the Commission issues the license or notifies the applicant otherwise.
An applicant for a license pursuant to § 32.53 shall conduct prototype tests on each of five prototype luminous safety devices for use in aircraft as follows:
(a)
Step 1. The internal temperature of the test chamber shall be reduced to −62 °C. (−80 °F.) and the device shall be maintained for at least 1 hour at this temperature at atmospheric pressure.
Step 2. The internal temperature of the test chamber shall be raised to −54 °C. (−65 °F.) and maintained until the temperature of the device has stabilized at −54 °C. at atmospheric pressure.
Step 3. The atmospheric pressure of the chamber shall be reduced to 83 millimeters of mercury absolute pressure while the chamber temperature is maintained at −54 °C.
Step 4. The internal temperature of the chamber shall be raised to −10 °C. (+14 °F.) and maintained until the temperature of the device has stabilized at −10 °C., and the internal pressure of the chamber shall then be adjusted to atmospheric pressure. The test chamber door shall then be opened in order that frost will form on the device, and shall remain open until the frost has melted but not long enough to allow the moisture to evaporate. The door shall then be closed.
Step 5. The internal temperature of the chamber shall be raised to +85 °C. (185 °F.) at atmospheric pressure. The temperature of the device shall be stabilized at +85 °C. and maintained for 2 hours. The device shall then be visually inspected to determine the extent of any deterioration.
Step 6. The chamber temperature shall be reduced to +71 °C. (160 °F.) at atmospheric pressure. The temperature of the device shall be stabilized at +71 °C. for a period of 30 minutes.
Step 7. The chamber temperature shall be reduced to +55 °C. (130 °F.) at atmospheric pressure. The temperature of the device shall be stabilized at this temperature for a period of 4 hours.
Step 8. The internal temperature of the chamber shall be reduced to +30 °C. (86 °F.) and the pressure to 138 millimeters of mercury absolute pressure and stabilized. The device shall be maintained under these conditions for a period of 4 hours.
Step 9. The temperature of the test chamber shall be raised to +35 °C. (95 °F.) and the pressure reduced to 83 millimeters of mercury absolute pressure and stabilized. The device shall be maintained under these conditions for a period of 30 minutes.
Step 10. The internal pressure of the chamber shall be maintained at 83 millimeters of mercury absolute pressure and the temperature reduced to +20 °C. (68 °F.) and stabilized. The device shall be maintained under these conditions for a period of 4 hours.
(b)
(1)
(2)
(3)
(c)
(d)
(e)
(f)
An applicant for a license pursuant to § 32.57 shall, for any type of source which is designed to contain more than 0.005 microcurie of americium-241, conduct prototype tests, in the order listed, on each of five prototypes of such source, which contains more than 0.005 microcurie of americium-241, as follows:
(a)
(b)
(c)
(d)
(e)
(f)
An applicant for a license pursuant to § 32.61 shall conduct prototype tests on each of five prototype ice detection devices as follows:
(a)
(b)
(c)
(d)
(e)
(a) A random sample shall be taken from each inspection lot of devices licensed under §§ 32.14, 32.53, or 32.61 of this part for which testing is required pursuant to §§ 32.15, 32.55, or 32.62 in accordance with the appropriate Sampling Table in this section determined by the designated Lot Tolerance Percent Defective. If the number of defectives in the sample does not exceed the acceptance number in the appropriate Sampling Table in this section, the lot shall be accepted. If the number of defectives in the sample exceeds the acceptance number in the appropriate Sampling Table in this section, the entire inspection lot shall be rejected.
(b) Single sampling tables for Lot Tolerance Percent Defective:
(1) Lot Tolerance Percent Defective 0.5 percent:
(2) Lot Tolerance Percent Defective 1.0 percent:
(3) Lot Tolerance Percent Defective 2.0 percent:
(4) Lot Tolerance Percent Defective 3.0 percent:
(5) Lot Tolerance Percent Defective 4.0 percent:
(6) Lot Tolerance Percent Defective 5.0 percent:
(7) Lot Tolerance Percent Defective 7.0 percent:
(8) Lot Tolerance Percent Defective 10.0 percent:
(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to NRC
(b) The request for review must be made in duplicate and sent to the U.S. Nuclear Regulatory Commission; Division of Industrial and Medical Nuclear Safety; Medical, Academic, and Commercial Use Safety Branch; Washington, DC 20555.
(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.
(d) The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria with the help of the manufacturer or distributor. The NRC shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.
(e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product.
(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with—
(1) The statements and representations, including quality control program, contained in the request; and
(2) The provisions of the registration certificate.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 32 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 32 that are not issued under subsections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 32.1, 32.2, 32.8, 32.11, 32.14, 32.17, 32.18, 32.22, 32.23, 32.24, 32.26, 32.27, 32.28, 32.51, 32.53, 32.57, 32.61, 32.71, 32.74, 32.301, and 32.303.
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
This part prescribes requirements for the issuance of specific licenses of broad scope for byproduct material (“broad licenses”) and certain regulations governing holders of such licenses. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of part 30 of this chapter apply to applications and licenses subject to this part.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0015.
(b) The approved information collection requirements contained in this part appear in §§ 33.12, 33.13, 33.14 and 33.15.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In § 33.12, NRC Form 313 is approved under control number 3150-0120.
(2) [Reserved]
(a) A “Type A specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the byproduct material specified in the license, but not exceeding quantities specified in the license, for purposes authorized by the Act. The quantities specified are usually in the multicurie range.
(b) A “Type B specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of byproduct material specified in § 33.100, Schedule A, of this part for purposes authorized by the Act. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in § 33.100, Schedule A, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in
(c) A “Type C specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of byproduct material specified in § 33.100, Schedule A, for purposes authorized by the Act. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in § 33.100, Schedule A, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in § 33.100, Schedule A, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.
A person may file an application for specific license of broad scope in duplicate on NRC Form 313, “Application for Material License,” in accordance with the provisions of § 30.32 of this chapter.
An application for a Type A specific license of broad scope will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;
(b) The applicant has engaged in a reasonable number of activities involving the use of byproduct material; and
(c) The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:
(1) The establishment of a radiation safety committee composed of such persons as a radiological safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive materials;
(2) The appointment of a radiological safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and
(3) The establishment of appropriate administrative procedures to assure:
(i) Control of procurement and use of byproduct material;
(ii) Completion of safety evaluations of proposed uses of byproduct material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and
(iii) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with paragraph (c)(3)(ii) of this section prior to use of the byproduct material.
An application for a Type B specific license of broad scope will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; and
(b) The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:
(1) The appointment of a radiological safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and
(2) The establishment of appropriate administrative procedures to assure:
(i) Control of procurement and use of byproduct material;
(ii) Completion of safety evaluations of proposed uses of byproduct material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and
(iii) Review, approval, and recording by the radiological safety officer of safety evaluations of proposed uses prepared in accordance with paragraph (b)(2)(ii) of this section prior to use of the byproduct material.
An application for a Type C specific license of broad scope will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; and
(b) The applicant submits a statement that byproduct material will be used only by, or under the direct supervision of, individuals who have received:
(1) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and
(2) At least 40 hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of byproduct material to be used; and
(c) The applicant has established administrative controls and provisions relating to procurement of byproduct material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.
An application filed pursuant to part 30 of this chapter for a specific license other than one of broad scope will be considered by the Commission as an application for a specific license of broad scope under this part if the requirements of the applicable sections of this part are satisfied.
(a) Unless specifically authorized pursuant to other parts of this chapter, persons licensed under this part shall not:
(1) Conduct tracer studies in the environment involving direct release of byproduct material;
(2) Receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of byproduct material in sealed sources used for irradiation of materials;
(3) Conduct activities for which a specific license issued by the Commission under part 32, 34, or 35 of this chapter is required; or
(4) Add or cause the addition of byproduct material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.
(b) Each Type A specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.
(c) Each Type B specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiological safety officer.
(d) Each Type C specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of § 33.15 of this part.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 33 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 33 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 33.1, 33.8, 33.11, 33.12, 33.13, 33.14, 33.15, 33.16, 33.21, 33.23 and 33.100.
Section 34.45 also issued under sec. 206, 88 Stat. 1246 (42 U.S.C. 5846).
This part prescribes requirements for the issuance of licenses for the use of sealed sources containing byproduct material and radiation safety requirements for persons using these sealed sources in industrial radiography. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the requirements and provisions of 10 parts 19, 20, 21, 30, 71, 150, 170, and 171 of this chapter apply to applications and licenses subject to this part. This rule does not apply to medical uses of byproduct material.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may nor conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0007.
(b) The approved information collection requirements contained in this part appear in §§ 34.13, 34.20, 34.25, 34.27, 34.29, 34.31, 34.33, 34.35, 34.41, 34.42, 34.43, 34.45, 34.47, 34.49, 34.53, 34.61, 34.63, 34.65, 34.67, 34.69, 34.71, 34.73, 34.75, 34.79, 34.81, 34.83, 34.85, 34.87, 34.89, 34.101, and appendix A.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. The information collection requirements and the control numbers under which it is approved are as follows:
(1) In § 34.11, NRC Form 313 is approved under control number 3150-0120.
(2) [Reserved]
A person may file an application for specific license for use of sealed sources in industrial radiography, in duplicate, on NRC Form 313, “Application for Material License,” in accordance with the provisions of § 30.32 of this chapter.
An application for a specific license for the use of licensed material in industrial radiography will be approved if the applicant meets the following requirements:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter for byproduct material, as appropriate, and any special requirements contained in this part.
(b) The applicant submits an adequate program for training radiographers and radiographers’ assistants that meets the requirements of § 34.43.
(1) After May 28, 1999, a license applicant need not describe its initial training and examination program for radiographers in the subjects outlined in § 34.43(g).
(2) From June 27, 1997 to May 28, 1999 a license applicant may affirm that all individuals acting as industrial radiographers will be certified in radiation safety by a certifying entity before commencing duty as radiographers. This affirmation substitutes for a description of its initial training and examination program for radiographers in the subjects outlined in § 34.43(g).
(c) The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.
(d) The applicant submits written operating and emergency procedures as described in § 34.45.
(e) The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographers’ assistant at intervals not to exceed 6 months as described in § 34.43(e).
(f) The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility.
(g) The applicant identifies and lists the qualifications of the individual(s) designated as the RSO (§ 34.42) and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with approved procedures.
(h) If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing and the qualifications of the person(s) authorized to do the leak testing. If the applicant intends to analyze its own wipe samples, the application must include a description of the procedures to be followed. The description must include the—
(1) Instruments to be used;
(2) Methods of performing the analysis; and
(3) Pertinent experience of the person who will analyze the wipe samples.
(i) If the applicant intends to perform “in-house” calibrations of survey instruments the applicant must describe methods to be used and the relevant experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in § 34.25.
(j) The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations.
(k) The applicant identifies the locations where all records required by this part and other parts of this chapter will be maintained.
Equipment used in industrial radiographic operations must meet the following minimum criteria:
(a)(1) Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standards Institute, N432-1980 “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography,” (published as NBS Handbook 136, issued January 1981). This publication has been approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a)and 1 CFR part 51. This publication may be purchased from the American National Standards Institute, Inc., 1430 Broadway, New York, New York 10018 Telephone (212) 642-4900. Copies of the document are available for inspection at the Nuclear Regulatory Commission Library, 11545 Rockville Pike, Rockville, Maryland 20852. A copy of the document is also on file at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC.
(2) Engineering analysis may be submitted by an applicant or licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the Commission may find this an acceptable alternative to actual testing of the component pursuant to the above referenced standard.
(b) In addition to the requirements specified in paragraph (a) of this section, the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources.
(1) The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the—
(i) Chemical symbol and mass number of the radionuclide in the device;
(ii) Activity and the date on which this activity was last measured;
(iii) Model (or product code) and serial number of the sealed source;
(iv) Manufacturer's identity of the sealed source; and
(v) Licensee's name, address, and telephone number.
(2) Radiographic exposure devices intended for use as Type B transport containers must meet the applicable requirements of 10 CFR part 71.
(3) Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless the design of any replacement component,including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system.
(c) In addition to the requirements specified in paragraphs (a) and (b) of this section, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers.
(1) The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.
(2) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.
(3) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.
(4)(i) Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words: “DANGER—RADIOACTIVE.”
(ii) The label may not interfere with the safe operation of the exposure device or associated equipment.
(5) The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use.
(6) Guide tubes must be used when moving the source out of the device.
(7) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.
(8) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432-1980.
(9) Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.
(d) All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of this section.
(e) Notwithstanding paragraph (a)(1) of this section, equipment used in industrial radiographic operations need not comply with § 8.9.2(c) of the Endurance Test in American National Standards Institute N432-1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism.
The maximum exposure rate limits for storage containers and source changers are 2 millisieverts (200 millirem) per hour at any exterior surface, and 0.1 millisieverts (10 millirem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position.
(a) Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked (and if a keyed-lock, with the key removed at all times) when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in § 34.51. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.
(b) Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked (and if a keyed-lock, with the key removed at all times) when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.
(a) The licensee shall keep sufficient calibrated and operable radiation survey instruments at each location where radioactive material is present to make the radiation surveys required by this part and by 10 CFR part 20 of this chapter. Instrumentation required by this section must be capable of measuring a range from 0.02 millisieverts (2 millirems) per hour through 0.01 sievert (1 rem) per hour.
(b) The licensee shall have each radiation survey instrument required under paragraph (a) of this section calibrated—
(1) At intervals not to exceed 6 months and after instrument servicing, except for battery changes;
(2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on
(3) So that an accuracy within plus or minus 20 percent of the calibration source can be demonstrated at each point checked.
(c) The licensee shall maintain records of the results of the instrument calibrations in accordance with § 34.65.
(a) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized to do so by the NRC or an Agreement State.
(b) The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the Commission or an Agreement State.
(c) Testing and recordkeeping requirements.
(1) Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed 6 months. The leak testing of the source must be performed using a method approved by the Commission or by an Agreement State. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 Bq (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis.
(2) The licensee shall maintain records of the leak tests in accordance with § 34.67.
(3) Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within 6 months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds 6 months.
(d) Any test conducted pursuant to paragraph (c) of this section which reveals the presence of 185 Bq (0.005 microcurie) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with Commission regulations. A report must be filed with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, within 5 days of any test with results that exceed the threshold in this subsection, describing the equipment involved, the test results, and the corrective action taken. A copy of the report must be sent to the Administrator of the appropriate Nuclear Regulatory Commission's Regional Office listed in appendix D of 10 CFR part 20 of this chapter “Standards for Protection Against Radiation.”
(e) Each exposure device using depleted uranium (DU) shielding and an “S” tube configuration must be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 Bq (0.005 microcuries) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis. Should such testing reveal the presence of 185 Bq (0.005 microcuries) or more of removable DU contamination, the exposure device must be removed from use until an evaluation of the wear on the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while in storage and not in use. Before using or transferring such a device however, the device must be tested for DU contamination if the interval of storage exceeded 12 months. A record of the DU leak-test must be made in accordance with § 34.67. Licensees will have until June 27, 1998, to
(a) Each licensee shall conduct a quarterly physical inventory to account for all sealed sources and for devices containing depleted uranium received and possessed under this license.
(b) The licensee shall maintain records of the quarterly inventory in accordance with § 34.69.
(a) The licensee shall perform visual and operability checks on survey meters, radiographic exposure devices, transport and storage containers, associated equipment and source changers before use on each day the equipment is to be used to ensure that the equipment is in good working condition, that the sources are adequately shielded, and that required labeling is present. Survey instrument operability must be performed using check sources or other appropriate means. If equipment problems are found, the equipment must be removed from service until repaired.
(b) Each licensee shall have written procedures for:
(1) Inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed 3 months or before the first use thereafter to ensure the proper functioning of components important to safety. Replacement components shall meet design specifications. If equipment problems are found, the equipment must be removed from service until repaired.
(2) Inspection and maintenance necessary to maintain the Type B packaging used to transport radioactive materials. The inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.
(c) Records of equipment problems and of any maintenance performed under paragraphs (a) and (b) of this section must be made in accordance with § 34.73.
(a) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:
(1) An entrance control of the type described in § 20.1601(a)(1) of this chapter that reduces the radiation level upon entry into the area, or
(2) Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed.
(b) The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry (designated in paragraph (a)(1) of this section) must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within 7 calendar days. The facility may continue to be used during this 7-day period, provided the licensee implements the continuous surveillance requirements of § 34.51 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarm must be maintained in accordance with § 34.75.
(a) The licensee may not use a source changer or a container to store licensed material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution
(b) The licensee may not transport licensed material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in 10 CFR part 71.
(c) Locked radiographic exposure devices and storage containers must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store licensed material in a manner which will minimize danger from explosion or fire.
(d) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the vehicle.
(a) Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of § 34.43(c). The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.
(b) All radiographic operations conducted at locations of use authorized on the license must be conducted in a permanent radiographic installation, unless specifically authorized by the Commission.
(c) A licensee may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the Commission or by an Agreement State.
(d) Licensees will have until June 27, 1998, to meet the requirements for having two qualified individuals present at locations other than a permanent radiographic installation as specified in paragraph (a) of this section.
The RSO shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's program.
(a) The minimum qualifications, training, and experience for RSOs for industrial radiography are as follows:
(1) Completion of the training and testing requirements of § 34.43(a);
(2) 2000 hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and
(3) Formal training in the establishment and maintenance of a radiation protection program.
(b) The Commission will consider alternatives when the RSO has appropriate training and/or experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.
(c) The specific duties and authorities of the RSO include, but are not limited to:
(1) Establishing and overseeing all operating, emergency, and ALARA procedures as required by 10 CFR part 20 of this chapter, and reviewing them regularly to ensure that the procedures in use conform to current 10 CFR part 20 procedures, conform to other NRC regulations and to the license conditions.
(2) Overseeing and approving all phases of the training program for radiographic personnel, ensuring that appropriate and effective radiation protection practices are taught;
(3) Ensuring that required radiation surveys and leak tests are performed and documented in accordance with the
(4) Ensuring that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by § 20.2203 of this chapter; and
(5) Ensuring that operations are conducted safely and to assume control for instituting corrective actions including stopping of operations when necessary.
(d) Licensees will have until June 27, 1999, to meet the requirements of paragraph (a) or (b) of this section.
(a) The licensee may not permit any individual to act as a radiographer until the individual—
(1) Has received training in the subjects in paragraph (g) of this section, in addition to a minimum of 2 months of on-the-job training, and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in appendix A of this part. (An independent organization that would like to be recognized as a certifying entity shall submit its request to the Director, Office of Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC. 20555-0001.) or
(2) The licensee may, until June 27, 1999, allow an individual who has not met the requirements of paragraph (a)(1) of this section, to act as a radiographer after the individual has received training in the subjects outlined in paragraph (g) of this section and demonstrated an understanding of these subjects by successful completion of a written examination that was previously submitted to and approved by the Commission.
(b) In addition, the licensee may not permit any individual to act as a radiographer until the individual—
(1) Has received copies of and instruction in the requirements described in NRC regulations contained in this part; in §§ 30.7, 30.9, and 30.10 of this chapter; in the applicable sections of 10 CFR parts 19 and 20, of this chapter, in applicable DOT regulations as referenced in 10 CFR part 71, in the NRC license(s) under which the radiographer will perform industrial radiography, and the licensee's operating and emergency procedures;
(2) Has demonstrated understanding of the licensee's license and operating and emergency procedures by successful completion of a written or oral examination covering this material.
(3) Has received training in the use of the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments.
(4) Has demonstrated understanding of the use of radiographic exposure devices, sources, survey instruments and associated equipment described in paragraphs (b)(1) and (b)(3) of this section by successful completion of a practical examination covering this material.
(c) The licensee may not permit any individual to act as a radiographer's assistant until the individual—
(1) Has received copies of and instruction in the requirements described in NRC regulations contained in this part, in §§ 30.7, 30.9, and 30.10 of this chapter, in the applicable sections of 10 CFR parts 19 and 20 of this chapter, in applicable DOT regulations as referenced in 10 CFR part 71, in the NRC license(s) under which the radiographer's assistant will perform industrial radiography, and the licensee's operating and emergency procedures;
(2) Has developed competence to use, under the personal supervision of the radiographer, the radiographic exposure devices, sealed sources, associated equipment, and radiation survey instruments that the assistant will use; and
(3) Has demonstrated understanding of the instructions provided under (c)(1) of this section by successfully completing a written test on the subjects covered and has demonstrated competence in the use of hardware described in (c)(2) of this section by successful completion of a practical examination on the use of such hardware.
(d) The licensee shall provide annual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed 12 months.
(e) Except as provided in paragraph (e)(4), the RSO or designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the Commission's regulations, license requirements, and the applicant's operating and emergency procedures are followed. The inspection program must:
(1) Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed 6 months; and
(2) Provide that, if a radiographer or a radiographer's assistant has not participated in an industrial radiographic operation for more than 6 months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of § 34.43(b)(3) and the radiographer's assistant must re-demonstrate knowledge of the training requirements of § 34.43(c)(2) by a practical examination before these individuals can next participate in a radiographic operation.
(3) The Commission may consider alternatives in those situations where the individual serves as both radiographer and RSO.
(4) In those operations where a single individual serves as both radiographer and RSO, and performs all radiography operations, an inspection program is not required.
(f) The licensee shall maintain records of the above training to include certification documents, written and practical examinations, refresher safety training and inspections of job performance in accordance with § 34.79.
(g) The licensee shall include the following subjects required in paragraph (a) of this section:
(1) Fundamentals of radiation safety including—
(i) Characteristics of gamma radiation;
(ii) Units of radiation dose and quantity of radioactivity;
(iii) Hazards of exposure to radiation;
(iv) Levels of radiation from licensed material; and
(v) Methods of controlling radiation dose (time, distance, and shielding);
(2) Radiation detection instruments including—
(i) Use, operation, calibration, and limitations of radiation survey instruments;
(ii) Survey techniques; and
(iii) Use of personnel monitoring equipment;
(3) Equipment to be used including—
(i) Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails).
(ii) Storage, control, and disposal of licensed material; and
(iii) Inspection and maintenance of equipment.
(4) The requirements of pertinent Federal regulations; and
(5) Case histories of accidents in radiography.
(h) Licensees will have until June 27, 1998, to comply with the additional training requirements specified in paragraphs (b)(1) and (c)(1) of this section.
(i) Licensees will have until June 27, 1999 to comply with the certification requirements specified in paragraph (a)(1) of this section. Records of radiographer certification maintained in accordance with § 34.79(a) provide appropriate affirmation of certification requirements specified in paragraph (a)(1) of this section.
(a) Operating and emergency procedures must include, as a minimum, instructions in the following:
(1) Appropriate handling and use of licensed sealed sources and radiographic exposure devices so that no person is likely to be exposed to radiation doses in excess of the limits established in 10 CFR part 20 of this chapter “Standards for Protection Against Radiation”;
(2) Methods and occasions for conducting radiation surveys;
(3) Methods for controlling access to radiographic areas;
(4) Methods and occasions for locking and securing radiographic exposure devices, transport and storage containers and sealed sources;
(5) Personnel monitoring and the use of personnel monitoring equipment;
(6) Transporting sealed sources to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when needed, and control of the sealed sources during transportation (refer to 49 CFR parts 171-173);
(7) The inspection, maintenance, and operability checks of radiographic exposure devices, survey instruments, transport containers, and storage containers;
(8) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarm ratemeter alarms unexpectedly.
(9) The procedure(s) for identifying and reporting defects and noncompliance, as required by 10 CFR part 21 of this chapter;
(10) The procedure for notifying proper persons in the event of an accident;
(11) Minimizing exposure of persons in the event of an accident;
(12) Source recovery procedure if licensee will perform source recovery;
(13) Maintenance of records.
(b) The licensee shall maintain copies of current operating and emergency procedures in accordance with §§ 34.81 and 34.89.
Whenever a radiographer's assistant uses radiographic exposure devices, associated equipment or sealed sources or conducts radiation surveys required by § 34.49(b) to determine that the sealed source has returned to the shielded position after an exposure, the assistant shall be under the personal supervision of a radiographer. The personal supervision must include:
(a) The radiographer's physical presence at the site where the sealed sources are being used;
(b) The availability of the radiographer to give immediate assistance if required; and
(c) The radiographer's direct observation of the assistant's performance of the operations referred to in this section.
(a) The licensee may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a direct reading dosimeter, an operating alarm ratemeter, and a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor. At permanent radiography installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required.
(1) Pocket dosimeters must have a range from zero to 2 millisieverts (200 millirems) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.
(2) Each personnel dosimeter must be assigned to and worn only by one individual.
(3) Film badges must be replaced at periods not to exceed one month and other personnel dosimeters processed and evaluated by an accredited NVLAP processor must be replaced at periods not to exceed three months.
(4) After replacement, each personnel dosimeter must be processed as soon as possible.
(b) Direct reading dosimeters such as pocket dosimeters or electronic personal dosimeters, must be read and the exposures recorded at the beginning and end of each shift, and records must be maintained in accordance with § 34.83.
(c) Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maintained in accordance with § 34.83. Acceptable dosimeters must read within plus or minus 20 percent of the true radiation exposure.
(d) If an individual's pocket chamber is found to be off-scale, or if his or her electronic personal dosimeter reads greater than 2 millisieverts (200 millirems), and the possibility of radiation exposure cannot be ruled out as the cause, the individual's personnel dosimeter must be sent for processing within 24 hours. In addition, the individual may not resume work associated with licensed material use until a determination of the individual's radiation exposure has been made. This determination must be made by the RSO or the RSO's designee. The results of this determination must be included in the records maintained in accordance with § 34.83.
(e) If the personnel dosimeter that is required by paragraph (a) of this section is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter meeting the requirements in paragraph (a) is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained in accordance with § 34.83.
(f) Dosimetry reports received from the accredited NVLAP personnel dosimeter processor must be retained in accordance with § 34.83.
(g) Each alarm ratemeter must—
(1) Be checked to ensure that the alarm functions properly (sounds) before using at the start of each shift;
(2) Be set to give an alarm signal at a preset dose rate of 5 mSv/hr (500 mrem/hr); with an accuracy of plus or minus 20 percent of the true radiation dose rate;
(3) Require special means to change the preset alarm function; and
(4) Be calibrated at periods not to exceed 12 months for correct response to radiation. The licensee shall maintain records of alarm ratemeter calibrations in accordance with § 34.83.
The licensee shall:
(a) Conduct surveys with a calibrated and operable radiation survey instrument that meets the requirements of § 34.25.
(b) Using a survey instrument meeting the requirements of paragraph (a) of this section, conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. The survey must determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment.
(c) Conduct a survey of the radiographic exposure device with a calibrated radiation survey instrument any time the source is exchanged and whenever a radiographic exposure device is placed in a storage area (as defined in § 34.3), to ensure that the sealed source is in its shielded position.
(d) Maintain records in accordance with § 34.85.
During each radiographic operation the radiographer, or the other individual present, as required by § 34.41, shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in 10 CFR part 20 of this chapter, except at permanent radiographic installations where all entryways are locked and the requirements of § 34.33 are met.
All areas in which industrial radiography is being performed must be conspicuously posted as required by § 20.1902(a) and (b) of this chapter. Exceptions listed in § 20.1903 of this chapter do not apply to industrial radiographic operations.
Each licensee shall maintain a copy of its license, license conditions, documents incorporated by reference, and
(a) Each licensee shall maintain records showing the receipts and transfers of sealed sources and devices using DU for shielding and retain each record for 3 years after it is made.
(b) These records must include the date, the name of the individual making the record, radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.
Each licensee shall maintain records of the calibrations of its radiation survey instruments that are required under § 34.25 and retain each record for 3 years after it is made.
Each licensee shall maintain records of leak test results for sealed sources and for devices containing DU. The results must be stated in units of becquerels (microcuries). The licensee shall retain each record for 3 years after it is made or until the source in storage is removed.
(a) Each licensee shall maintain records of the quarterly inventory of sealed sources and of devices containing depleted uranium as required by § 34.29 and retain each record for 3 years after it is made.
(b) The record must include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of becquerels (curies) or mass (for DU) in each device, location of sealed source and/or devices, and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.
(a) Each licensee shall maintain utilization logs showing for each sealed source the following information:
(1) A description, including the make, model, and serial number of the radiographic exposure device or transport or storage container in which the sealed source is located;
(2) The identity and signature of the radiographer to whom assigned; and
(3) The plant or site where used and dates of use, including the dates removed and returned to storage.
(b) The licensee shall retain the logs required by paragraph (a) of this section for 3 years after the log is made.
(a) Each licensee shall maintain records specified in § 34.31 of equipment problems found in daily checks and quarterly inspections of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments; and retain each record for 3 years after it is made.
(b) The record must include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was done.
Each licensee shall maintain records of alarm system and entrance control device tests required under § 34.33 and retain each record for 3 years after it is made.
Each licensee shall maintain the following records (of training and certification) for 3 years after the record is made:
(a) Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents and verification of certification status,
(b) Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's assistant. The records must list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any non-compliances observed by the RSO.
Each licensee shall maintain a copy of current operating and emergency procedures until the Commission terminates the license. Superseded material must be retained for 3 years after the change is made.
Each licensee shall maintain the following exposure records specified in § 34.47:
(a) Direct reading dosimeter readings and yearly operability checks required by § 34.47 (b) and (c) for 3 years after the record is made.
(b) Records of alarm ratemeter calibrations for 3 years after the record is made.
(c) Personnel dosimeter results received from the accredited NVLAP processor until the Commission terminates the license.
(d) Records of estimates of exposures as a result of: off-scale personal direct reading dosimeters, or lost or damaged personnel dosimeters until the Commission terminates the license.
Each licensee shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in § 34.49(c), if that survey is the last one performed in the workday. Each record must be maintained for 3 years after it is made.
Each record required by this part must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a) Each licensee shall maintain copies of records required by this part and other applicable parts of this chapter at the location specified in § 34.13(k).
(b) Each licensee shall also maintain copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite;
(1) The license authorizing the use of licensed material;
(2) A copy of 10 CFR parts 19, 20, and 34 of NRC regulations;
(3) Utilization records for each radiographic exposure device dispatched from that location as required by § 34.71.
(4) Records of equipment problems identified in daily checks of equipment as required by § 34.73(a);
(5) Records of alarm system and entrance control checks required by § 34.75, if applicable;
(6) Records of direct reading dosimeters such as pocket dosimeter and/or electronic personal dosimeters readings as required by § 34.83;
(7) Operating and emergency procedures required by § 34.81;
(8) Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by § 34.65;
(9) Evidence of the latest calibrations of alarm ratemeters and operability checks of pocket dosimeters and/or electronic personal dosimeters as required by § 34.83;
(10) Latest survey records required by § 34.85;
(11) The shipping papers for the transportation of radioactive materials required by § 71.5 of this chapter; and
(12) When operating under reciprocity pursuant to § 150.20 of this chapter, a copy of the Agreement State license authorizing the use of licensed materials.
(a) In addition to the reporting requirements specified in § 30.50 and under other sections of this chapter, such as § 21.21, each licensee shall provide a written report to the U.S. Nuclear Regulatory Commission, Division of Industrial and Medical Nuclear Safety, Washington, DC 20555-0001, with a copy to the Director, Incident Response Operations, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, within 30 days of the occurrence of any of the following incidents involving radiographic equipment:
(1) Unintentional disconnection of the source assembly from the control cable;
(2) Inability to retract the source assembly to its fully shielded position and secure it in this position; or
(3) Failure of any component (critical to safe operation of the device) to properly perform its intended function;
(b) The licensee shall include the following information in each report submitted under paragraph (a) of this section, and in each report of overexposure submitted under 10 CFR 20.2203 which involves failure of safety components of radiography equipment:
(1) A description of the equipment problem;
(2) Cause of each incident, if known;
(3) Name of the manufacturer and model number of equipment involved in the incident;
(4) Place, date, and time of the incident;
(5) Actions taken to establish normal operations;
(6) Corrective actions taken or planned to prevent recurrence; and
(7) Qualifications of personnel involved in the incident.
(c) Any licensee conducting radiographic operations or storing radioactive material at any location not listed on the license for a period in excess of 180 days in a calendar year, shall notify the appropriate NRC regional office listed in § 30.6(a)(2) of this chapter prior to exceeding the 180 days.
The Commission may, upon application of any interested person or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it determines the exemption is authorized by law and would not endanger life or property or the common defense and security and is otherwise in the public interest.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to these Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under Section 234 of the Atomic Energy Act;
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section.
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1952, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under one or more of §§ 161b, 161i, or 161o of the Act. For purposes of Section 223, all the regulations in 10 CFR part 34 are issued under one or more of §§ 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in 10 CFR part 34 that are not issued under sections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 34.1, 34.3, 34.5, 34.8, 34.11, 34.13, 34.111, 34.121, 34.123.
An independent certifying organization shall:
1. Be an organization such as a society or association, whose members participate in, or have an interest in, the fields of industrial radiography;
2. Make its membership available to the general public nationwide that is not restricted because of race, color, religion, sex, age, national origin or disability;
3. Have a certification program open to nonmembers, as well as members;
4. Be an incorporated, nationally recognized organization, that is involved in setting national standards of practice within its fields of expertise;
5. Have an adequate staff, a viable system for financing its operations, and a policy-and decision-making review board;
6. Have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies;
7. Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and procedures, and to advise the organization's staff in implementing the certification program;
8. Have a committee, whose members can carry out their responsibilities impartially, to review complaints against certified individuals and to determine appropriate sanctions;
9. Have written procedures describing all aspects of its certification program, maintain records of the current status of each individual's certification and the administration of its certification program;
10. Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against certified individuals;
11. Have procedures for proctoring examinations, including qualifications for proctors. These procedures must ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees;
12. Exchange information about certified individuals with the Commission and other independent certifying organizations and/or Agreement States and allow periodic review of its certification program and related records; and
13. Provide a description to the Commission of its procedures for choosing examination sites and for providing an appropriate examination environment.
All certification programs must:
1. Require applicants for certification to (a) receive training in the topics set forth in § 34.43(g) or equivalent Agreement State regulations, and (b) satisfactorily complete a written examination covering these topics;
2. Require applicants for certification to provide documentation that demonstrates that the applicant has: (a) received training in the topics set forth in § 34.43(g) or equivalent Agreement State regulations; (b) satisfactorily completed a minimum period of on-the-job training; and (c) has received verification by an Agreement State or a NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer;
3. Include procedures to ensure that all examination questions are protected from disclosure;
4. Include procedures for denying an application, revoking, suspending, and reinstating a certificate;
5. Provide a certification period of not less than 3 years nor more than 5 years;
6. Include procedures for renewing certifications and, if the procedures allow renewals without examination, require evidence of recent full-time employment and annual refresher training.
7. Provide a timely response to inquiries, by telephone or letter, from members of the
All examinations must be:
1. Designed to test an individual's knowledge and understanding of the topics listed in § 34.43(g) or equivalent Agreement State requirements;
2. Written in a multiple-choice format;
3. Have test items drawn from a question bank containing psychometrically valid questions based on the material in § 34.43(g).
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
This part contains the requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19, 20, 21, 30, 71, 170, and 171 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.
(1) Meets the requirements in §§ 35.51(a) and 35.59; or
(2) Is identified as an authorized medical physicist or teletherapy physicist on—
(i) A specific medical use license issued by the Commission or Agreement State;
(ii) A medical use permit issued by a Commission master material licensee;
(iii) A permit issued by a Commission or Agreement State broad scope medical use licensee; or
(iv) A permit issued by a Commission master material license broad scope medical use permittee.
(1) Meets the requirements in §§ 35.55(a) and 35.59; or
(2) Is identified as an authorized nuclear pharmacist on—
(i) A specific license issued by the Commission or Agreement State that authorizes medical use or the practice of nuclear pharmacy;
(ii) A permit issued by a Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;
(iii) A permit issued by a Commission or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or
(iv) A permit issued by a Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or
(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or
(4) Is designated as an authorized nuclear pharmacist in accordance with § 32.72(b)(4).
(1) Meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 35.690(a); or
(2) Is identified as an authorized user on—
(i) A Commission or Agreement State license that authorizes the medical use of byproduct material;
(ii) A permit issued by a Commission master material licensee that is authorized to permit the medical use of byproduct material;
(iii) A permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or
(iv) A permit issued by a Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material.
(1) In a written directive; or
(2) In accordance with the directions of the authorized user for procedures performed pursuant to §§ 35.100 and 35.200.
(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;
(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;
(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or
(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.
(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and
(2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.
(1) Meets the requirements in §§ 35.50(a) and 35.59; or
(2) Is identified as a Radiation Safety Officer on—
(i) A specific medical use license issued by the Commission or Agreement State; or
(ii) A medical use permit issued by a Commission master material licensee.
Each record required by this part must be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license for the uses authorized on its license.
(b) If the research is conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research—
(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and
(2) Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject.
(c) If the research will not be conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its NRC medical use license. The amendment request must include a written commitment that the licensee will, before conducting research—
(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and
(2) Obtain “informed consent”, as defined and described in the Federal Policy, from the human research subject.
(d) Nothing in this section relieves licensees from complying with the other requirements in this part.
Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.
(a) The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid
(b) The approved information collection requirements contained in this part appear in §§ 35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 35.310, 35.315, 35.390, 35.392, 35.394, 35.404, 35.406, 35.410, 35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 35.652, 35.655, 35.690, 35.900, 35.910, 35.920, 35.930, 35.940, 35.950, 35.960, 35.961, 35.980, 35.981, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.3045, 35.3047, and 35.3067.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In § 35.12, NRC Form 313, including NRC Form 313A, which licensees may use to provide supplemental information, is approved under control number 3150-0120.
(2) [Reserved]
(a) A licensee shall implement the provisions in this part on or before October 24, 2002, with the exception of the requirements listed in paragraph (b) of this section.
(b) A licensee shall implement the training requirements in §§ 35.50(a), 35.51(a), 35.55(a), 35.59, 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a) on or before October 25, 2004.
(c) Prior to October 25, 2004, a licensee shall satisfy the training requirements of this part for a Radiation Safety Officer, an authorized medical physicist, an authorized nuclear pharmacist, or an authorized user by complying with either:
(1) The appropriate training requirements in subpart J; or
(2) The appropriate training requirements in subpart B or subparts D through H.
(d) If a license condition exempted a licensee from a provision of Part 35 on October 24, 2002, then the license condition continues to exempt the licensee from the requirements in the corresponding provision of §§ 35.1-35.4002.
(e) When a requirement in this part differs from the requirement in an existing license condition, the requirement in this part shall govern.
(f) A licensee shall continue to comply with any license condition that requires it to implement procedures required by §§ 35.610, 35.642, 35.643, and 35.645 until there is a license amendment or renewal that modifies the license condition.
(a) A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer byproduct material for medical use only in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraphs (b)(1) or (b)(2) of this section.
(b) A specific license is not needed for an individual who—
(1) Receives, possesses, uses, or transfers byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in § 35.27, unless prohibited by license condition; or
(2) Prepares unsealed byproduct material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in § 35.27, unless prohibited by license condition.
(a) An application must be signed by the applicant's or licensee's management.
(b) An application for a license for medical use of byproduct material as described in §§ 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000 must be made by—
(1) Filing an original and one copy of NRC Form 313, “Application for Material License,” that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, authorized user(s), authorized medical physicist(s), and authorized nuclear pharmacist(s); and
(2) Submitting procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable.
(c) A request for a license amendment or renewal must be made by—
(1) Submitting an original and one copy of either—
(i) NRC Form 313, “Application for Material License”; or
(ii) A letter requesting the amendment or renewal; and
(2) Submitting procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable.
(d) In addition to the requirements in paragraphs (b) and (c) of this section, an application for a license or amendment for medical use of byproduct material as described in § 35.1000 must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in Subparts A through C of this part.
(1) The applicant shall also provide specific information on—
(i) Radiation safety precautions and instructions;
(ii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and
(iii) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.
(2) The applicant or licensee shall also provide any other information requested by the Commission in its review of the application.
(e) An applicant that satisfies the requirements specified in § 33.13 of this chapter may apply for a Type A specific license of broad scope.
A licensee shall apply for and must receive a license amendment—
(a) Before it receives, prepares, or uses byproduct material for a type of use that is permitted under this part, but that is not authorized on the licensee's current license issued under this part;
(b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except—
(1) For an authorized user, an individual who meets the requirements in §§ 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), 35.690(a), 35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.950(a), or 35.960(a) and 35.59;
(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§ 35.55(a) or 35.980(a) and 35.59;
(3) For an authorized medical physicist, an individual who meets the requirements in §§ 35.51(a) or 35.961(a) or (b) and 35.59;
(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist—
(i) On a Commission or Agreement State license or other equivalent permit or license recognized by NRC that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy;
(ii) On a permit issued by a Commission or Agreement State specific license of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy;
(iii) On a permit issued by a Commission master material licensee that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy; or
(iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists.
(c) Before it changes Radiation Safety Officers, except as provided in § 35.24(c);
(d) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;
(e) Before it adds to or changes the areas of use identified in the application or on the license, except for areas of use where byproduct material is used only in accordance with either § 35.100 or § 35.200;
(f) Before it changes the address(es) of use identified in the application or on the license; and
(g) Before it revises procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety.
(a) A licensee shall provide the Commission a copy of the board certification, the Commission or Agreement State license, the permit issued by a Commission master material licensee, the permit issued by a Commission or Agreement State licensee of broad scope, or the permit issued by a Commission master material license broad scope permittee for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist, under § 35.13 (b)(1) through (b)(4).
(b) A licensee shall notify the Commission by letter no later than 30 days after:
(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;
(2) The licensee's mailing address changes;
(3) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in § 30.34(b) of this chapter; or
(4) The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100 or § 35.200.
(c) The licensee shall mail the documents required in this section to the appropriate address identified in § 30.6 of this chapter.
A licensee possessing a Type A specific license of broad scope for medical use, issued under Part 33 of this chapter, is exempt from—
(a) The provisions of § 35.12(d) regarding the need to file an amendment to the license for medical use of byproduct material, as described in § 35.1000;
(b) The provisions of § 35.13(b);
(c) The provisions of § 35.13(e) regarding additions to or changes in the areas of use at the addresses identified in the application or on the license;
(d) The provisions of § 35.14(a);
(e) The provisions of § 35.14(b)(1) for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist;
(f) The provisions of § 35.14(b)(4) regarding additions to or changes in the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100 or § 35.200.
(g) The provisions of § 35.49(a).
(a) The Commission shall issue a license for the medical use of byproduct material if—
(1) The applicant has filed NRC Form 313 “Application for Material License” in accordance with the instructions in § 35.12;
(2) The applicant has paid any applicable fee as provided in Part 170 of this chapter;
(3) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this Chapter for the protection of the public health and safety; and
(4) The applicant meets the requirements of Part 30 of this chapter.
(b) The Commission shall issue a license for mobile medical service if the applicant:
(1) Meets the requirements in paragraph (a) of this section; and
(2) Assures that individuals or human research subjects to whom unsealed byproduct material or radiation from implants containing byproduct material will be administered may be released following treatment in accordance with § 35.75.
The Commission may, upon application of any interested person or upon its own initiative, grant exemptions from the regulations in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
(a) In addition to the radiation protection program requirements of § 20.1101 of this chapter, a licensee's management shall approve in writing—
(1) Requests for a license application, renewal, or amendment before submittal to the Commission;
(2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and
(3) Radiation protection program changes that do not require a license amendment and are permitted under § 35.26;
(b) A licensee's management shall appoint a Radiation Safety Officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements.
(c) For up to 60 days each year, a licensee may permit an authorized user or an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in paragraph (g) of this section, if the licensee takes the actions required in paragraphs (b), (e), (g), and (h) of this section and notifies the Commission in accordance with § 35.14(b).
(d) A licensee may simultaneously appoint more than one temporary Radiation Safety Officer in accordance with paragraph (c) of this section, if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of uses of byproduct material permitted by the license.
(e) A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety Officer in writing.
(f) Licensees that are authorized for two or more different types of uses of byproduct material under Subparts E, F, and H of this part, or two or more types of units under Subpart H of this part, shall establish a Radiation Safety Committee to oversee all uses of byproduct material permitted by the license. The Committee must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. The Committee may include other members the licensee considers appropriate.
(g) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to—
(1) Identify radiation safety problems;
(2) Initiate, recommend, or provide corrective actions;
(3) Stop unsafe operations; and,
(4) Verify implementation of corrective actions.
(h) A licensee shall retain a record of actions taken under paragraphs (a), (b), and (e) of this section in accordance with § 35.2024.
(a) A licensee may revise its radiation protection program without Commission approval if—
(1) The revision does not require a license amendment under § 35.13;
(2) The revision is in compliance with the regulations and the license ;
(3) The revision has been reviewed and approved by the Radiation Safety Officer and licensee management; and
(4) The affected individuals are instructed on the revised program before the changes are implemented.
(b) A licensee shall retain a record of each change in accordance with § 35.2026.
(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user, as allowed by § 35.11(b)(1), shall—
(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of byproduct material; and
(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of byproduct material.
(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by § 35.11(b)(2), shall—
(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual's involvement with byproduct material; and
(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, written radiation protection procedures established by the licensee, the regulations of this chapter, and license conditions.
(c) A licensee that permits supervised activities under paragraphs (a) and (b) of this section is responsible for the acts and omissions of the supervised individual.
(a) A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 Megabecquerels (MBq) (30 microcuries (μCi)), any therapeutic dosage of unsealed byproduct material or any therapeutic dose of radiation from byproduct material.
(1) If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within 48 hours of the oral directive.
(b) The written directive must contain the patient or human research subject's name and the following information—
(1) For any administration of quantities greater than 1.11 MBq (30 μCi) of sodium iodide I-131: the dosage;
(2) For an administration of a therapeutic dosage of unsealed byproduct material other than sodium iodide I-131: the radioactive drug, dosage, and route of administration;
(3) For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;
(4) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;
(5) For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or
(6) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:
(i) Before implantation: treatment site, the radionuclide, and dose; and
(ii) After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose).
(c) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration
(1) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within 48 hours of the oral revision.
(d) The licensee shall retain a copy of the written directive in accordance with § 35.2040.
(a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:
(1) The patient's or human research subject's identity is verified before each administration; and
(2) Each administration is in accordance with the written directive.
(b) At a minimum, the procedures required by paragraph (a) of this section must address the following items that are applicable to the licensee's use of byproduct material—
(1) Verifying the identity of the patient or human research subject;
(2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;
(3) Checking both manual and computer-generated dose calculations; and
(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by § 35.600.
(c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with § 35.2041.
For medical use, a licensee may only use—
(a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State;
(b) Sealed sources or devices noncommercially transferred from a Part 35 licensee; or
(c) Teletherapy sources manufactured and distributed in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an Agreement State.
Except as provided in § 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in § 35.24 to be an individual who—
(a) Is certified by a specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed a structured educational program consisting of both:
(i) 200 hours of didactic training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Radiation biology; and
(E) Radiation dosimetry; and
(ii) One year of full-time radiation safety experience under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license or permit issued by a Commission master material licensee that authorizes similar type(s) of use(s) of byproduct material involving the following—
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages,
(C) Securing and controlling byproduct material;
(D) Using administrative controls to avoid mistakes in the administration of byproduct material;
(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;
(F) Using emergency procedures to control byproduct material; and
(G) Disposing of byproduct material; and
(2) Has obtained written certification, signed by a preceptor Radiation Safety Officer, that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of radiation safety knowledge sufficient to function independently as a Radiation Safety Officer for a medical use licensee; or
(c) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual has Radiation Safety Officer responsibilities.
Except as provided in § 35.57, the licensee shall require the authorized medical physicist to be an individual who—
(a) Is certified by a specialty board whose certification process includes all of the training and experience requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Holds a master's or doctor's degree in physics, biophysics, radiological physics, medical physics, or health physics and has completed 1 year of full-time training in therapeutic radiological physics and an additional year of full-time work experience under the supervision of an authorized medical physicist at a medical institution that includes the tasks listed in §§ 35.67, 35.433, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, and 35.652, as applicable; and
(2) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written certification must be signed by a preceptor authorized medical physicist who meets the requirements in § 35.51 or equivalent Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
Except as provided in § 35.57, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who—
(a) Is certified as a nuclear pharmacist by a specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed 700 hours in a structured educational program consisting of both:
(i) Didactic training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Supervised practical experience in a nuclear pharmacy involving—
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages,
(C) Calculating, assaying, and safely preparing dosages for patients or human research subjects;
(D) Using administrative controls to avoid medical events in the administration of byproduct material; and
(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and
(2) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.
(a) An individual identified as a Radiation Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license or a permit issued by a Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope before October 24, 2002 need not comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively.
(b) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permittee before October 24, 2002 who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Subparts D-H of this part.
The training and experience specified in Subparts B, D, E, F, G, H, and J of this part must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.
(a) For direct measurements performed in accordance with § 35.63, a licensee shall possess and use instrumentation to measure the activity of unsealed byproduct material before it is administered to each patient or human research subject.
(b) A licensee shall calibrate the instrumentation required in paragraph (a) of this section in accordance with nationally recognized standards or the manufacturer's instructions.
(c) A licensee shall retain a record of each instrument calibration required by this section in accordance with § 35.2060.
(a) A licensee shall calibrate the survey instruments used to show compliance with this part and 10 CFR Part 20 before first use, annually, and following a repair that affects the calibration. A licensee shall—
(1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;
(2) Calibrate two separated readings on each scale or decade that will be used to show compliance; and
(3) Conspicuously note on the instrument the date of calibration.
(b) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.
(c) A licensee shall retain a record of each survey instrument calibration in accordance with § 35.2061.
(a) A licensee shall determine and record the activity of each dosage before medical use.
(b) For a unit dosage, this determination must be made by—
(1) Direct measurement of radioactivity; or
(2) A decay correction, based on the activity or activity concentration determined by—
(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(ii) An NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA.
(c) For other than unit dosages, this determination must be made by—
(1) Direct measurement of radioactivity;
(2) Combination of measurement of radioactivity and mathematical calculations; or
(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements.
(d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.
(e) A licensee shall retain a record of the dosage determination required by this section in accordance with § 35.2063.
Any person authorized by § 35.11 for medical use of byproduct material may receive, possess, and use any of the following byproduct material for check, calibration, transmission, and reference use.
(a) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations.
(b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under § 32.74 of this chapter, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.
(c) Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi).
(d) Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 μCi) or 1000 times the quantities in Appendix B of Part 30 of this chapter.
(e) Technetium-99m in amounts as needed.
(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.
(b) A licensee in possession of a sealed source shall—
(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and
(2) Test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the Commission or an Agreement State in the Sealed Source and Device Registry.
(c) To satisfy the leak test requirements of this section, the licensee shall measure the sample so that the leak test can detect the presence of 185 Bq (0.005 μCi) of radioactive material in the sample.
(d) A licensee shall retain leak test records in accordance with § 35.2067(a).
(e) If the leak test reveals the presence of 185 Bq (0.005 μCi) or more of removable contamination, the licensee shall—
(1) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in parts 20 and 30 of this chapter; and
(2) File a report within 5 days of the leak test in accordance with § 35.3067.
(f) A licensee need not perform a leak test on the following sources:
(1) Sources containing only byproduct material with a half-life of less than 30 days;
(2) Sources containing only byproduct material as a gas;
(3) Sources containing 3.7 MBq (100 μCi) or less of beta or gamma-emitting material or 0.37 MBq (10 μCi) or less of alpha-emitting material;
(4) Seeds of iridium-192 encased in nylon ribbon; and
(5) Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within 6 months before the date of use or transfer.
(g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with § 35.2067(b).
Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.
(a) In addition to the surveys required by Part 20 of this chapter, a licensee shall survey with a radiation detection survey instrument at the end of each day of use. A licensee shall survey all areas where unsealed byproduct material requiring a written directive was prepared for use or administered.
(b) A licensee does not need to perform the surveys required by paragraph (a) of this section in an area(s) where patients or human research subjects are confined when they cannot be released under § 35.75.
(c) A licensee shall retain a record of each survey in accordance with § 35.2070.
(a) A licensee may authorize the release from its control of any individual who has been administered unsealed byproduct material or implants containing byproduct material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).
(b) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include—
(1) Guidance on the interruption or discontinuation of breast-feeding; and
(2) Information on the potential consequences, if any, of failure to follow the guidance.
(c) A licensee shall maintain a record of the basis for authorizing the release of an individual in accordance with § 35.2075(a).
(d) The licensee shall maintain a record of instructions provided to a breast-feeding female in accordance with § 35.2075(b).
(a) A licensee providing mobile medical service shall—
(1) Obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;
(2) Check instruments used to measure the activity of unsealed byproduct material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this paragraph must include a constancy check;
(3) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and
(4) Before leaving a client's address, survey all areas of use to ensure compliance with the requirements in Part 20 of this chapter.
(b) A mobile medical service may not have byproduct material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the byproduct material. Byproduct material delivered to the client must be received and handled in conformance with the client's license.
(c) A licensee providing mobile medical services shall retain the letter required in paragraph (a)(1) and the record of each survey required in paragraph (a)(4) of this section in accordance with § 35.2080(a) and (b), respectively.
(a) A licensee may hold byproduct material with a physical half-life of less than 120 days for decay-in-storage before disposal without regard to its radioactivity if it—
(1) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and
(2) Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.
(b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with § 35.2092.
Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is—
(a) Obtained from a manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in §§ 35.290 or 35.390, or an individual under the supervision of either as specified in § 35.27; or
(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.
Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.100 to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under §§ 35.290 or 35.390 or equivalent Agreement State requirements; or
(c)(1) Has completed 60 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user who meets the requirements in § 35.190, § 35.290, or § 35.390 or equivalent Agreement State requirements, involving—
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(F) Administering dosages of radioactive drugs to patients or human research subjects; and
(2) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in §§ 35.190, 35.290, or 35.390 or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.100.
Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is—
(a) Obtained from a manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in §§ 35.290 or 35.390, or an individual under the supervision of either as specified in § 35.27;
(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.
(a) A licensee may not administer to humans a radiopharmaceutical that contains more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m).
(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section.
(c) If a licensee is required to measure the molybdenum-99 concentration, the licensee shall retain a record of each measurement in accordance with § 35.2204.
Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.200 to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under § 35.390 or equivalent Agreement State requirements; or
(c)(1) Has completed 700 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. The training and experience must include, at a minimum,—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use;
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user, who meets the requirements in §§ 35.290 or 35.390 or equivalent Agreement State requirements, involving—
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;
(F) Administering dosages of radioactive drugs to patients or human research subjects; and
(G) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
(2) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in §§ 35.290 or 35.390 or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under §§ 35.100 and 35.200.
A licensee may use any unsealed byproduct material prepared for medical use and for which a written directive is required that is—
(a) Obtained from a manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in §§ 35.290 or 35.390, or an individual under the supervision of either as specified in § 35.27; or
(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or
(d) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.
In addition to the requirements of § 19.12 of this chapter,
(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects
(1) Patient or human research subject control;
(2) Visitor control, including—
(i) Routine visitation to hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter;
(3) Contamination control;
(4) Waste control; and
(5) Notification of the Radiation Safety Officer, or his or her designee, and the authorized user if the patient or the human research subject has a medical emergency or dies.
(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.
(a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall—
(1) Quarter the patient or the human research subject either in—
(i) A private room with a private sanitary facility; or
(ii) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under § 35.75;
(2) Visibly post the patient's or the human research subject's room with a “Radioactive Materials” sign.
(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and
(4) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle the material and items as radioactive waste.
(b) A licensee shall notify the Radiation Safety Officer, or his or her designee, and the authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.
Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.300 to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or(b)(1) Has completed 700 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The training and experience must include—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user who meets the requirements in § 35.390(a), § 35.390(b), or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)(
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Calibrating instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;
(F) Eluting generator systems, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
(G) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status—
(
(
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(2) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.300. The written certification must be signed by a preceptor authorized user who meets the requirements in § 35.390(a), § 35.390(b), or equivalent Agreement State requirements. The preceptor authorized user, who meets the requirements in § 35.390(b), must have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)(
Except as provided in § 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under § 35.390(a), § 35.390(b), for uses listed in § 35.390(b)(1)(ii)(G)(
(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Chemistry of byproduct material for medical use; and
(v) Radiation biology; and
(2) Has work experience, under the supervision of an authorized user who meets the requirements in § 35.390(a), § 35.390(b), § 35.392, § 35.394, or equivalent Agreement State requirements. A supervising authorized user who meets the requirements in § 35.390(b), must have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(
(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(ii) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation for survey meters;
(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;
(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and
(3) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under § 35.300. The written certification must be signed by a preceptor authorized user who meets the requirements in § 35.390(a), § 35.390(b), § 35.392, § 35.394, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirement in § 35.390(b), must have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(
Except as provided in § 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under § 35.390(a), § 35.390(b) for uses listed in § 35.390(b)(1)(ii)(G)(
(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Chemistry of byproduct material for medical use; and
(v) Radiation biology; and
(2) Has work experience, under the supervision of an authorized user who meets the requirements in § 35.390(a), § 35.390(b), § 35.394, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(
(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(ii) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation for survey meters;
(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;
(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and
(3) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under § 35.300. The written certification must be signed by a preceptor authorized user who meets the requirements in § 35.390(a), § 35.390(b), § 35.394, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in
A licensee shall use only brachytherapy sources for therapeutic medical uses:
(a) As approved in the Sealed Source and Device Registry; or
(b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met.
(a) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.
(b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.
(c) A licensee shall retain a record of the surveys required by paragraphs (a) and (b) of this section in accordance with § 35.2404.
(a) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.
(b) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.
(c) A licensee shall maintain a record of the brachytherapy source accountability in accordance with § 35.2406.
In addition to the requirements of § 19.12 of this chapter,
(a) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the—
(1) Size and appearance of the brachytherapy sources;
(2) Safe handling and shielding instructions;
(3) Patient or human research subject control;
(4) Visitor control, including both:
(i) Routine visitation of hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter; and
(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.
(a) For each patient or human research subject who is receiving brachytherapy and cannot be released under § 35.75, a licensee shall—
(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;
(2) Visibly post the patient's or human research subject's room with a “Radioactive Materials” sign; and
(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.
(b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source—
(1) Dislodged from the patient; and
(2) Lodged within the patient following removal of the source applicators.
(c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.
(a) Before the first medical use of a brachytherapy source on or after October 24, 2002, a licensee shall have—
(1) Determined the source output or activity using a dosimetry system that meets the requirements of § 35.630(a);
(2) Determined source positioning accuracy within applicators; and
(3) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of paragraphs (a)(1) and (a)(2) of this section.
(b) A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with paragraph (a) of this section.
(c) A licensee shall mathematically correct the outputs or activities determined in paragraph (a) of this section for physical decay at intervals consistent with 1 percent physical decay.
(d) A licensee shall retain a record of each calibration in accordance with § 35.2432.
(a) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under § 35.432.
(b) A licensee shall retain a record of the activity of each strontium-90 source in accordance with § 35.2433.
The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:
(a) The source-specific input parameters required by the dose calculation algorithm;
(b) The accuracy of dose, dwell time, and treatment time calculations at representative points;
(c) The accuracy of isodose plots and graphic displays; and
(d) The accuracy of the software used to determine sealed source positions from radiographic images.
Except as provided in § 35.57, the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under § 35.400 to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes—
(i) 200 hours of classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in § 35.490 or equivalent Agreement State requirements at a medical institution, involving—
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Checking survey meters for proper operation;
(C) Preparing, implanting, and removing brachytherapy sources;
(D) Maintaining running inventories of material on hand;
(E) Using administrative controls to prevent a medical event involving the use of byproduct material;
(F) Using emergency procedures to control byproduct material; and
(2) Has obtained 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in § 35.490 or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in § 35.490 or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (b)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under § 35.400.
Except as provided in § 35.57, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who—
(a) Is an authorized user under § 35.490 or equivalent Agreement State requirements; or
(b)(1) Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity; and
(iv) Radiation biology; and
(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve—
(i) Examination of each individual to be treated;
(ii) Calculation of the dose to be administered;
(iii) Administration of the dose; and
(iv) Follow up and review of each individual's case history; and
(3) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in § 35.490, § 35.491, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (a) and (b) of this section and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.
A licensee shall use only sealed sources for diagnostic medical uses as approved in the Sealed Source and Device Registry.
Except as provided in § 35.57, the licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized under § 35.500 to be a physician, dentist, or podiatrist who—
(a) Is certified by a specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Has had 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include—
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity;
(4) Radiation biology; and
(5) Training in the use of the device for the uses requested.
A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:
(a) As approved in the Sealed Source and Device Registry; or
(b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met.
(a) Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.
(b) A licensee shall retain a record of these surveys in accordance with § 35.2404.
(a) Only a person specifically licensed by the Commission or an Agreement State shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).
(b) Except for low dose-rate remote afterloader units, only a person specifically licensed by the Commission or an Agreement State shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.
(c) For a low dose-rate remote afterloader unit, only a person specifically licensed by the Commission or an Agreement State or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.
(d) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with § 35.2605.
(a) A licensee shall—
(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;
(2) Permit only individuals approved by the authorized user, Radiation Safety Officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);
(3) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and
(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include—
(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
(ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and
(iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
(b) A copy of the procedures required by paragraph (a)(4) of this section must be physically located at the unit console.
(c) A licensee shall post instructions at the unit console to inform the operator of—
(1) The location of the procedures required by paragraph (a)(4) of this section; and
(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
(d) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in—
(1) The procedures identified in paragraph (a)(4) of this section; and
(2) The operating procedures for the unit.
(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
(f) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with § 35.2310.
(g) A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) in accordance with § 35.2610.
(a) A licensee shall control access to the treatment room by a door at each entrance.
(b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will—
(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;
(2) Cause the source(s) to be shielded when an entrance door is opened; and
(3) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.
(c) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.
(d) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.
(e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.
(f) In addition to the requirements specified in paragraphs (a) through (e) of this section, a licensee shall—
(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require—
(i) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and
(ii) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.
(2) For high dose-rate remote afterloader units, require—
(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and
(ii) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in
(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.
(4) Notify the Radiation Safety Officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.
(g) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source—
(1) Remaining in the unshielded position; or
(2) Lodged within the patient following completion of the treatment.
(a) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.
(1) The system must have been calibrated using a system or source traceable to the National Institute of Science and Technology (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous 2 years and after any servicing that may have affected system calibration; or
(2) The system must have been calibrated within the previous 4 years. Eighteen to thirty months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must indicate that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.
(b) The licensee shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section.
(c) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with § 35.2630.
(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit—
(1) Before the first medical use of the unit; and
(2) Before medical use under the following conditions:
(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location;
(iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and
(3) At intervals not exceeding 1 year.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of—
(1) The output within ±3 percent for the range of field sizes and for the distance or range of distances used for medical use;
(2) The coincidence of the radiation field and the field indicated by the light beam localizing device;
(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam;
(4) Timer accuracy and linearity over the range of use;
(5) On-off error; and
(6) The accuracy of all distance measuring and localization devices in medical use.
(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.
(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies.
(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at intervals consistent with 1 percent decay for all other nuclides.
(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist.
(g) A licensee shall retain a record of each calibration in accordance with § 35.2632.
(a) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit—
(1) Before the first medical use of the unit;
(2) Before medical use under the following conditions:
(i) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and
(ii) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and
(3) At intervals not exceeding 1 quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and
(4) At intervals not exceeding 1 year for low dose-rate remote afterloader units.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include, as applicable, determination of:
(1) The output within ± 5 percent;
(2) Source positioning accuracy to within ±1 millimeter;
(3) Source retraction with backup battery upon power failure;
(4) Length of the source transfer tubes;
(5) Timer accuracy and linearity over the typical range of use;
(6) Length of the applicators; and
(7) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.
(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output.
(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies.
(e) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (b) of this section, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 quarter.
(f) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with paragraphs (a) through (e) of this section.
(g) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay at intervals consistent with 1 percent physical decay.
(h) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (g) of this section must be performed by the authorized medical physicist.
(i) A licensee shall retain a record of each calibration in accordance with § 35.2632.
(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit—
(1) Before the first medical use of the unit;
(2) Before medical use under the following conditions—
(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and
(iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and
(3) At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of—
(1) The output within ±3 percent;
(2) Relative helmet factors;
(3) Isocenter coincidence;
(4) Timer accuracy and linearity over the range of use;
(5) On-off error;
(6) Trunnion centricity;
(7) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;
(8) Helmet microswitches;
(9) Emergency timing circuits; and
(10) Stereotactic frames and localizing devices (trunnions).
(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.
(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies.
(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.
(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist.
(g) A licensee shall retain a record of each calibration in accordance with § 35.2632.
(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of—
(1) Timer accuracy, and timer linearity over the range of use;
(2) On-off error;
(3) The coincidence of the radiation field and the field indicated by the light beam localizing device;
(4) The accuracy of all distance measuring and localization devices used for medical use;
(5) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b); and
(6) The difference between the measurement made in paragraph (a)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).
(b) A licensee shall perform measurements required by paragraph (a) of this
(c) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.
(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of—
(1) Electrical interlocks at each teletherapy room entrance;
(2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);
(3) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;
(4) Viewing and intercom systems;
(5) Treatment room doors from inside and outside the treatment room; and
(6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
(e) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section, and a copy of the procedures required by paragraph (b), in accordance with § 35.2642.
(a) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit—
(1) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;
(2) Before each patient treatment with a low dose-rate remote afterloader unit; and
(3) After each source installation.
(b) A licensee shall perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.
(c) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.
(d) To satisfy the requirements of paragraph (a) of this section, spot-checks must, at a minimum, assure proper operation of—
(1) Electrical interlocks at each remote afterloader unit room entrance;
(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;
(3) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;
(4) Emergency response equipment;
(5) Radiation monitors used to indicate the source position;
(6) Timer accuracy;
(7) Clock (date and time) in the unit's computer; and
(8) Decayed source(s) activity in the unit's computer.
(e) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(f) A licensee shall retain a record of each check required by paragraph (d) of this section and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2643.
(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit—
(1) Monthly;
(2) Before the first use of the unit on a given day; and
(3) After each source installation.
(b) A licensee shall—
(1) Perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.
(2) Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.
(c) To satisfy the requirements of paragraph (a)(1) of this section, spot-checks must, at a minimum—
(1) Assure proper operation of—
(i) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;
(ii) Helmet microswitches;
(iii) Emergency timing circuits; and
(iv) Stereotactic frames and localizing devices (trunnions).
(2) Determine—
(i) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b);
(ii) The difference between the measurement made in paragraph (c)(2)(i) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);
(iii) Source output against computer calculation;
(iv) Timer accuracy and linearity over the range of use;
(v) On-off error; and
(vi) Trunnion centricity.
(d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of this section, spot-checks must assure proper operation of—
(1) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;
(2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;
(3) Viewing and intercom systems;
(4) Timer termination;
(5) Radiation monitors used to indicate room exposures; and
(6) Emergency off buttons.
(e) A licensee shall arrange for the repair of any system identified in paragraph (c) of this section that is not operating properly as soon as possible.
(f) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(g) A licensee shall retain a record of each check required by paragraphs (c) and (d) and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2645.
(a) A licensee providing mobile remote afterloader service shall—
(1) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and
(2) Account for all sources before departure from a client's address of use.
(b) In addition to the periodic spot-checks required by § 35.643, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of—
(1) Electrical interlocks on treatment area access points;
(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;
(3) Viewing and intercom systems;
(4) Applicators, source transfer tubes, and transfer tube-applicator interfaces;
(5) Radiation monitors used to indicate room exposures;
(6) Source positioning (accuracy); and
(7) Radiation monitors used to indicate whether the source has returned to a safe shielded position.
(c) In addition to the requirements for checks in paragraph (b) of this section, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.
(d) If the results of the checks required in paragraph (b) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(e) A licensee shall retain a record of each check required by paragraph (b) of this section in accordance with § 35.2647.
(a) In addition to the survey requirement in § 20.1501 of this chapter, a person licensed under this subpart shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.
(b) The licensee shall make the survey required by paragraph (a) of this section at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).
(c) A licensee shall retain a record of the radiation surveys required by paragraph (a) of this section in accordance with § 35.2652.
(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism.
(b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State.
(c) A licensee shall keep a record of the inspection and servicing in accordance with § 35.2655.
The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:
(a) The source-specific input parameters required by the dose calculation algorithm;
(b) The accuracy of dose, dwell time, and treatment time calculations at representative points;
(c) The accuracy of isodose plots and graphic displays;
(d) The accuracy of the software used to determine sealed source positions from radiographic images; and
(e) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.
Except as provided in § 35.57, the licensee shall require an authorized user of a sealed source for a use authorized under § 35.600 to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes—
(i) 200 hours of classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in § 35.690 or equivalent Agreement State requirements at a medical institution, involving—
(A) Reviewing full calibration measurements and periodic spot-checks;
(B) Preparing treatment plans and calculating treatment doses and times;
(C) Using administrative controls to prevent a medical event involving the use of byproduct material;
(D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;
(E) Checking and using survey meters; and
(F) Selecting the proper dose and how it is to be administered; and
(2) Has completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in § 35.690 or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (b)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written certification must be signed by a preceptor authorized user who meets the requirements in § 35.690 or equivalent Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status.
Except as provided in § 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in § 35.24 to be an individual who—
(a) Is certified by the—
(1) American Board of Health Physics in Comprehensive Health Physics;
(2) American Board of Radiology;
(3) American Board of Nuclear Medicine;
(4) American Board of Science in Nuclear Medicine;
(5) Board of Pharmaceutical Specialties in Nuclear Pharmacy;
(6) American Board of Medical Physics in radiation oncology physics;
(7) Royal College of Physicians and Surgeons of Canada in nuclear medicine;
(8) American Osteopathic Board of Radiology; or
(9) American Osteopathic Board of Nuclear Medicine; or
(b) Has had classroom and laboratory training and experience as follows—
(1) 200 hours of classroom and laboratory training that includes—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Radiation biology; and
(v) Radiopharmaceutical chemistry; and
(2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or
(c) Is an authorized user identified on the licensee's license.
Except as provided in § 35.57, the licensee shall require the authorized user of a radiopharmaceutical in § 35.100(a) to be a physician who—
(a) Is certified in—
(1) Nuclear medicine by the American Board of Nuclear Medicine;
(2) Diagnostic radiology by the American Board of Radiology;
(3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology;
(4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
(5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or
(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, and supervised clinical experience as follows—
(1) 40 hours of classroom and laboratory training that includes—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Radiation biology; and
(v) Radiopharmaceutical chemistry; and
(2) 20 hours of supervised clinical experience under the supervision of an authorized user and that includes—
(i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;
(ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;
(iii) Administering dosages to patients or human research subjects and using syringe radiation shields;
(iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and
(v) Patient or human research subject follow up; or
(c) Has successfully completed a 6-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section.
Except as provided in § 35.57, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit in § 35.200(a) to be a physician who—
(a) Is certified in—
(1) Nuclear medicine by the American Board of Nuclear Medicine;
(2) Diagnostic radiology by the American Board of Radiology;
(3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology;
(4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
(5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or
(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, supervised work experience, and supervised clinical experience as follows—
(1) 200 hours of classroom and laboratory training that includes—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Radiopharmaceutical chemistry; and
(v) Radiation biology; and
(2) 500 hours of supervised work experience under the supervision of an authorized user that includes—
(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters;
(iii) Calculating and safely preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent the medical event of byproduct material;
(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(vi) Eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; and
(3) 500 hours of supervised clinical experience under the supervision of an authorized user that includes—
(i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;
(ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;
(iii) Administering dosages to patients or human research subjects and using syringe radiation shields;
(iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and
(v) Patient or human research subject follow up; or
(c) Has successfully completed a 6-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section.
Except as provided in § 35.57, the licensee shall require the authorized user of radiopharmaceuticals in § 35.300 to be a physician who—
(a) Is certified by—
(1) The American Board of Nuclear Medicine;
(2) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology;
(3) The Royal College of Physicians and Surgeons of Canada in nuclear medicine; or
(4) The American Osteopathic Board of Radiology after 1984; or
(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows—
(1) 80 hours of classroom and laboratory training that includes—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity; and
(iv) Radiation biology; and
(2) Supervised clinical experience under the supervision of an authorized user at a medical institution that includes—
(i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and
(ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals.
Except as provided in § 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experience as follows—
(a) 80 hours of classroom and laboratory training that includes—
(1) Radiation physics and instrumentation;
(2) Radiation protection,
(3) Mathematics pertaining to the use and measurement of radioactivity; and
(4) Radiation biology; and
(b) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for diagnosis of thyroid function, and the treatment of hyperthyroidism in 10 individuals.
Except as provided in § 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows—
(a) 80 hours of classroom and laboratory training that includes—
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity; and
(4) Radiation biology; and
(b) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for the treatment of thyroid carcinoma in 3 individuals.
Except as provided in § 35.57, the licensee shall require the authorized user of a brachytherapy source listed in § 35.400 for therapy to be a physician who—
(a) Is certified in—
(1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;
(2) Radiation oncology by the American Osteopathic Board of Radiology;
(3) Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or
(4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
(b) Is in the active practice of therapeutic radiology, has had classroom and laboratory training in radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources, supervised work experience, and supervised clinical experience as follows—
(1) 200 hours of classroom and laboratory training that includes—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity; and
(iv) Radiation biology;
(2) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes—
(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(ii) Checking survey meters for proper operation;
(iii) Preparing, implanting, and removing sealed sources;
(iv) Maintaining running inventories of material on hand;
(v) Using administrative controls to prevent a medical event involving byproduct material; and
(vi) Using emergency procedures to control byproduct material; and
(3) Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes—
(i) Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications;
(ii) Selecting the proper brachytherapy sources and dose and method of administration;
(iii) Calculating the dose; and
(iv) Post-administration follow up and review of case histories in collaboration with the authorized user.
Except as provided in § 35.57, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory
(a) 24 hours of classroom and laboratory training that includes—
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity; and
(4) Radiation biology;
(b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes—
(1) Examination of each individual to be treated;
(2) Calculation of the dose to be administered;
(3) Administration of the dose; and
(4) Follow up and review of each individual's case history.
Except as provided in § 35.57, the licensee shall require the authorized user of a sealed source in a device listed in § 35.500 to be a physician, dentist, or podiatrist who—
(a) Is certified in—
(1) Radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;
(2) Nuclear medicine by the American Board of Nuclear Medicine;
(3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or
(4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
(b) Has had 8 hours of classroom and laboratory training in basic radioisotope handling techniques specifically applicable to the use of the device that includes—
(1) Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation;
(2) Radiation biology;
(3) Radiation protection; and
(4) Training in the use of the device for the uses requested.
Except as provided in § 35.57, the licensee shall require the authorized user of a sealed source listed in § 35.600 to be a physician who—
(a) Is certified in—
(1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;
(2) Radiation oncology by the American Osteopathic Board of Radiology;
(3) Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or
(4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
(b) Is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a therapeutic medical device, supervised work experience, and supervised clinical experience as follows—
(1) 200 hours of classroom and laboratory training that includes—
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity; and
(iv) Radiation biology;
(2) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes—
(i) Review of the full calibration measurements and periodic spot-checks;
(ii) Preparing treatment plans and calculating treatment times;
(iii) Using administrative controls to prevent medical events;
(iv) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical device or console; and
(v) Checking and using survey meters; and
(3) Three years of supervised clinical experience that includes one year in a formal training program approved by
(i) Examining individuals and reviewing their case histories to determine their suitability for teletherapy, remote afterloader, or gamma stereotactic radiosurgery treatment, and any limitations or contraindications;
(ii) Selecting the proper dose and how it is to be administered;
(iii) Calculating the doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses as warranted by patients' or human research subjects' reaction to radiation; and
(iv) Post-administration follow up and review of case histories.
The licensee shall require the authorized medical physicist to be an individual who—
(a) Is certified by the American Board of Radiology in—
(1) Therapeutic radiological physics;
(2) Roentgen ray and gamma ray physics;
(3) X-ray and radium physics; or
(4) Radiological physics; or
(b) Is certified by the American Board of Medical Physics in radiation oncology physics; or
(c) Holds a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and has completed 1 year of full time training in therapeutic radiological physics and an additional year of full time work experience under the supervision of a medical physicist at a medical institution that includes the tasks listed in §§ 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 35.645 and 35.652, as applicable.
The licensee shall require the authorized nuclear pharmacist to be a pharmacist who—
(a) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties; or
(b)(1) Has completed 700 hours in a structured educational program consisting of both—
(i) Didactic training in the following areas:
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Supervised experience in a nuclear pharmacy involving the following—
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;
(C) Calculating, assaying, and safely preparing dosages for patients or human research subjects;
(D) Using administrative controls to avoid mistakes in the administration of byproduct material;
(E) Using procedures to prevent or minimize contamination and using proper decontamination procedures; and
(2) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy.
A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual
A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through H of this part if—
(a) The applicant or licensee has submitted the information required by § 35.12(b) through (d); and
(b) The applicant or licensee has received written approval from the Commission in a license or license amendment and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material.
(a) A licensee shall retain a record of actions taken by the licensee's management in accordance with § 35.24(a) for 5 years. The record must include a summary of the actions taken and a signature of licensee management.
(b) The licensee shall retain a copy of both authority, duties, and responsibilities of the Radiation Safety Officer as required by § 35.24(e), and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by § 35.24(b), for the duration of the license. The records must include the signature of the Radiation Safety Officer and licensee management.
A licensee shall retain a record of each radiation protection program change made in accordance with § 35.26(a) for 5 years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change.
A licensee shall retain a copy of each written directive as required by § 35.40 for 3 years.
A licensee shall retain a copy of the procedures required by § 35.41(a) for the duration of the license.
A licensee shall maintain a record of instrument calibrations required by § 35.60 for 3 years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.
A licensee shall maintain a record of radiation survey instrument calibrations required by § 35.61 for 3 years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.
(a) A licensee shall maintain a record of dosage determinations required by § 35.63 for 3 years.
(b) The record must contain—
(1) The radiopharmaceutical;
(2) The patient's or human research subject's name, or identification number if one has been assigned;
(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 μCi);
(4) The date and time of the dosage determination; and
(5) The name of the individual who determined the dosage.
(a) A licensee shall retain records of leak tests required by § 35.67(b) for 3 years. The records must include the model number, and serial number if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.
(b) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by § 35.67(g) for 3 years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.
A licensee shall retain a record of each survey required by § 35.70 for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.
(a) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with § 35.75, if the total effective dose equivalent is calculated by—
(1) Using the retained activity rather than the activity administered;
(2) Using an occupancy factor less than 0.25 at 1 meter;
(3) Using the biological or effective half-life; or
(4) Considering the shielding by tissue.
(b) A licensee shall retain a record that the instructions required by § 35.75(b) were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).
(c) The records required by paragraphs (a) and (b) of this section must be retained for 3 years after the date of release of the individual.
(a) A licensee shall retain a copy of each letter that permits the use of byproduct material at a client's address, as required by § 35.80(a)(1). Each letter must clearly delineate the authority and responsibility of the licensee and the client and must be retained for 3 years after the last provision of service.
(b) A licensee shall retain the record of each survey required by § 35.80(a)(4) for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.
A licensee shall maintain records of the disposal of licensed materials, as required by § 35.92, for 3 years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.
A licensee shall maintain a record of the molybdenum-99 concentration tests required by § 35.204(b) for 3 years. The record must include, for each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per
A licensee shall maintain a record of safety instructions required by §§ 35.310, 35.410, and 35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.
A licensee shall maintain a record of the surveys required by §§ 35.404 and 35.604 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.
(a) A licensee shall maintain a record of brachytherapy source accountability required by § 35.406 for 3 years.
(b) For temporary implants, the record must include—
(1) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and
(2) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.
(c) For permanent implants, the record must include—
(1) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;
(2) The number and activity of sources not implanted, the date they were returned to storage, and the name of the individual who returned them to storage; and
(3) The number and activity of sources permanently implanted in the patient or human research subject.
(a) A licensee shall maintain a record of the calibrations of brachytherapy sources required by § 35.432 for 3 years after the last use of the source.
(b) The record must include—
(1) The date of the calibration;
(2) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;
(3) The source output or activity;
(4) The source positioning accuracy within the applicators; and
(5) The signature of the authorized medical physicist.
(a) A licensee shall maintain a record of the activity of a strontium-90 source required by § 35.433 for the life of the source.
(b) The record must include—
(1) The date and initial activity of the source as determined under § 35.432; and
(2) For each decay calculation, the date and the source activity as determined under § 35.433.
A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.
A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) until the licensee no longer
(a) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with § 35.630 for the duration of the license.
(b) For each calibration, intercomparison, or comparison, the record must include—
(1) The date;
(2) The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of § 35.630;
(3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and
(4) The names of the individuals who performed the calibration, intercomparison, or comparison.
(a) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by §§ 35.632, 35.633, and 35.635 for 3 years.
(b) The record must include—
(1) The date of the calibration;
(2) The manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrate the unit(s);
(3) The results and an assessment of the full calibrations;
(4) The results of the autoradiograph required for low dose-rate remote afterloader units; and
(5) The signature of the authorized medical physicist who performed the full calibration.
(a) A licensee shall retain a record of each periodic spot-check for teletherapy units required by § 35.642 for 3 years.
(b) The record must include—
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;
(3) An assessment of timer linearity and constancy;
(4) The calculated on-off error;
(5) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;
(6) The determined accuracy of each distance measuring and localization device;
(7) The difference between the anticipated output and the measured output;
(8) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and
(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
(c) A licensee shall retain a copy of the procedures required by § 35.642(b) until the licensee no longer possesses the teletherapy unit.
(a) A licensee shall retain a record of each spot-check for remote afterloader units required by § 35.643 for 3 years.
(b) The record must include, as applicable—
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;
(3) An assessment of timer accuracy;
(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and
(5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
(c) A licensee shall retain a copy of the procedures required by § 35.643(b) until the licensee no longer possesses the remote afterloader unit.
(a) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years.
(b) The record must include—
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;
(3) An assessment of timer linearity and accuracy;
(4) The calculated on-off error;
(5) A determination of trunnion centricity;
(6) The difference between the anticipated output and the measured output;
(7) An assessment of source output against computer calculations;
(8) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and
(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
(c) A licensee shall retain a copy of the procedures required by § 35.645(b) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.
(a) A licensee shall retain a record of each check for mobile remote afterloader units required by § 35.647 for 3 years.
(b) The record must include—
(1) The date of the check;
(2) The manufacturer's name, model number, and serial number of the remote afterloader unit;
(3) Notations accounting for all sources before the licensee departs from a facility;
(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces, and source positioning accuracy; and
(5) The signature of the individual who performed the check.
(a) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with § 35.652 for the duration of use of the unit.
(b) The record must include—
(1) The date of the measurements;
(2) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;
(3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and
(4) The signature of the individual who performed the test.
(a) A licensee shall maintain a record of the 5-year inspections for teletherapy and gamma stereotactic radiosurgery units required by § 35.655 for the duration of use of the unit.
(b) The record must contain—
(1) The inspector's radioactive materials license number;
(2) The date of inspection;
(3) The manufacturer's name and model number and serial number of both the treatment unit and source;
(4) A list of components inspected and serviced, and the type of service; and
(5) The signature of the inspector.
(a) A licensee shall report any event, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material results in—
(1) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and
(i) The total dose delivered differs from the prescribed dose by 20 percent or more;
(ii) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or
(iii) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.
(2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following—
(i) An administration of a wrong radioactive drug containing byproduct material;
(ii) An administration of a radioactive drug containing byproduct material by the wrong route of administration;
(iii) An administration of a dose or dosage to the wrong individual or human research subject;
(iv) An administration of a dose or dosage delivered by the wrong mode of treatment; or
(v) A leaking sealed source.
(3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site).
(b) A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.
(c) The licensee shall notify by telephone the NRC Operations Center
(d) The licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 15 days after discovery of the medical event.
(1) The written report must include—
(i) The licensee's name;
(ii) The name of the prescribing physician;
(iii) A brief description of the event;
(iv) Why the event occurred;
(v) The effect, if any, on the individual(s) who received the administration;
(vi) What actions, if any, have been taken or are planned to prevent recurrence; and
(vii) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.
(2) The report may not contain the individual's name or any other information that could lead to identification of the individual.
(e) The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without
(f) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.
(g) A licensee shall:
(1) Annotate a copy of the report provided to the NRC with the:
(i) Name of the individual who is the subject of the event; and
(ii) Social security number or other identification number, if one has been assigned, of the individual who is the subject of the event; and
(2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.
(a) A licensee shall report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.
(b) A licensee shall report any dose to a nursing child that is a result of an administration of byproduct material to a breast-feeding individual that—
(1) Is greater than 50 mSv (5 rem) total effective dose equivalent; or
(2) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
(c) The licensee shall notify by telephone the NRC Operations Center no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraphs (a) or (b) in this section.
(d) The licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraphs (a) or (b) in this section.
(1) The written report must include—
(i) The licensee's name;
(ii) The name of the prescribing physician;
(iii) A brief description of the event;
(iv) Why the event occurred;
(v) The effect, if any, on the embryo/fetus or the nursing child;
(vi) What actions, if any, have been taken or are planned to prevent recurrence; and
(vii) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.
(2) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.
(e) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under paragraph (a) or (b) of this section, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother
(f) A licensee shall:
(1) Annotate a copy of the report provided to the NRC with the:
(i) Name of the pregnant individual or the nursing child who is the subject of the event; and
(ii) Social security number or other identification number, if one has been assigned, of the pregnant individual or the nursing child who is the subject of the event; and
(2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.
A licensee shall file a report within 5 days if a leak test required by § 35.67 reveals the presence of 185 Bq ( 0.005 μCi) or more of removable contamination. The report must be filed with the appropriate NRC Regional Office listed in § 30.6 of this chapter, with a copy to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The written report must include the model number and serial number if assigned, of the leaking source; the radionuclide and its estimated activity; the results of the test; the date of the test; and the action taken.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued under those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under Section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued under the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under Section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of Section 223, all the regulations in 10 CFR part 35 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in 10 CFR part 35 that are not issued under subsections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19, 35.65, 35.100, 35.200, 35.300, 35.4001, and 35.4002.
Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
(a) This part contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. This part also contains radiation safety requirements for operating irradiators. The requirements of this part are in addition to other requirements of this chapter. In particular, the provisions of parts 19, 20, 21, 30, 71, 170, and 171 of this chapter apply to applications and licenses subject to this part. Nothing in this part relieves the licensee from complying with other applicable Federal, State and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.
(b) The regulations in this part apply to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates exceed 5 grays (500 rads) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this part.
(c) The regulations in this part do not apply to self-contained dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0158.
(b) The approved information collection requirements contained in this part appear in §§ 36.11, 36.13, 36.17, 36.19, 36.21, 36.53, 36.69, 36.81, and 36.83.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers
(1) In § 36.11, NRC Form 313 is approved under control number 3150-0120.
(2) [Reserved]
A person, as defined in § 30.4 of this chapter, may file an application for a specific license authorizing the use of sealed sources in an irradiator on Form NRC 313, “Application for Material License.” Each application for a license, other than a license exempted from part 170 of this chapter, must be accompanied by the fee prescribed in § 170.31 of this chapter. The application and one copy must be sent to the appropriate NRC Regional Office listed in appendix D to part 20 of this chapter.
The Commission will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section.
(a) The applicant shall satisfy the general requirements specified in § 30.33 of this chapter and the requirements contained in this part.
(b) The application must describe the training provided to irradiator operators including—
(1) Classroom training;
(2) On-the-job or simulator training;
(3) Safety reviews;
(4) Means employed by the applicant to test each operator's understanding of the Commission's regulations and licensing requirements and the irradiator operating and emergency procedures; and
(5) Minimum training and experience of personnel who may provide training.
(c) The application must include an outline of the written operating and emergency procedures listed in § 36.53 that describes the radiation safety aspects of the procedures.
(d) The application must describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application must specify who, within the management structure, has the authority to stop unsafe operations. The application must also describe the training and experience required for the position of radiation safety officer.
(e) The application must include a description of the access control systems required by § 36.23, the radiation monitors required by § 36.29, the method of detecting leaking sources required by § 36.59 including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.
(f) If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the Commission. The description must include the—
(1) Instruments to be used;
(2) Methods of performing the analysis; and
(3) Pertinent experience of the individual who analyzes the samples.
(g) If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading must be done by an organization specifically authorized by the Commission or an Agreement State to load or unload irradiator sources.
(h) The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by § 36.61.
The applicant may not begin construction of a new irradiator prior to the submission to NRC of both an application for a license for the irradiator and the fee required by § 170.31. As used in this section, the
(a) The Commission may, upon application of any interested person or upon its own initiative, grant any exemptions from the requirements in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
(b) Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this part. The Commission will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that they are likely to provide an adequate level of safety for workers and the public.
(a) After the filing of the original application, the Commission may request further information necessary to enable the Commission to determine whether the application should be granted or denied.
(b) Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the Commission's request, submit written statements to enable the Commission to determine whether the license should be modified, suspended, or revoked.
(a)
(1) Must have a certificate of registration issued under 10 CFR 32.210;
(2) Must be doubly encapsulated;
(3) Must use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator;
(4) Must be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools; and
(5) In prototype testing of the sealed source, must have been leak tested and found leak-free after each of the tests described in paragraphs (b) through (g) of this section.
(b)
(c)
(d)
(e)
(f)
(g)
(a) Each entrance to a radiation room at a panoramic irradiator must have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It must not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed must cause the sources to return promptly to their shielded position. The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources. The doors and barriers must not prevent any individual in the radiation room from leaving.
(b) In addition, each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make the individual entering the room aware of the hazard. The alarm must also alert at least one other individual who is onsite of the entry. That individual shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.
(c) A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels, must activate the alarm described in paragraph (b) of this section. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.
(d) Before the sources move from their shielded position in a panoramic irradiator, the source control must automatically activate conspicuous visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position. The alarms must give individuals enough time to leave the room before the sources leave the shielded position.
(e) Each radiation room at a panoramic irradiator must have a clearly visible and readily accessible control that would allow an individual in the room to make the sources return to their fully shielded position.
(f) Each radiation room of a panoramic irradiator must contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control.
(g) Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator must be posted as required by 10 CFR 20.1902. Radiation postings for panoramic irradiators must comply with the posting requirements of 10 CFR 20.1902, except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.
(h) If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.
(i) Underwater irradiators must have a personnel access barrier around the pool which must be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access barrier. There must be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) who is
(a) The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (2 millirems) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed 100 square centimeters having no linear dimension greater than 20 cm. Areas where the radiation dose rate exceeds 0.02 millisievert (2 millirems) per hour must be locked, roped off, or posted.
(b) The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 0.02 millisievert (2 millirems) per hour when the sources are in the fully shielded position.
(c) The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (2 millirems) per hour and at 5 centimeters from the shield may not exceed 0.2 millisievert (20 millirems) per hour.
(a) The radiation room at a panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected.
(b) The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas.
(a) Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility who is prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of this paragraph.
(b) Underwater irradiators that are not in a shielded radiation room must have a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond promptly.
(a) The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key.
(b) The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in the fully shielded position, when they are in transit, and when the sources are exposed.
(c) The control console of a panoramic irradiator must have a control that promptly returns the sources to the shielded position.
(d) Each control for a panoramic irradiator must be clearly marked as to its function.
(a) For licenses initially issued after July 1, 1993, irradiator pools must either:
(1) Have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool; or
(2) Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination. In either case, the licensee shall have a method to safely store the sources during repairs of the pool.
(b) For licenses initially issued after July 1, 1993, irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons must have siphon breakers to prevent the siphoning of pool water.
(c) A means must be provided to replenish water losses from the pool.
(d) A visible indicator must be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level.
(e) Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly.
(f) A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations.
(g) If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not exceed 0.02 millisievert (2 millirems) per hour.
If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.
(a) If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically return to the shielded position.
(b) The lock on the door of the radiation room of a panoramic irradiator may not be deactivated by a power failure.
(c) During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter.
Irradiators whose construction begins after July 1, 1993, must meet the design requirements of this section.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
The requirements of this section must be met for irradiators whose construction begins after July 1, 1993. The requirements must be met prior to loading sources.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(a) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must be instructed in:
(1) The fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination, units of radiation dose, NRC dose limits, why large radiation doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic function of the irradiator);
(2) The requirements of parts 19 and 36 of NRC regulations that are relevant to the irradiator;
(3) The operation of the irradiator;
(4) Those operating and emergency procedures listed in § 36.53 that the individual is responsible for performing; and
(5) Case histories of accidents or problems involving irradiators.
(b) Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision.
(c) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating and
(d) The licensee shall conduct safety reviews for irradiator operators at least annually. The licensee shall give each operator a brief written test on the information. Each safety review must include, to the extent appropriate, each of the following—
(1) Changes in operating and emergency procedures since the last review, if any;
(2) Changes in regulations and license conditions since the last review, if any;
(3) Reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any;
(4) Relevant results of inspections of operator safety performance;
(5) Relevant results of the facility's inspection and maintenance checks; and
(6) A drill to practice an emergency or abnormal event procedure.
(e) The licensee shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct any mistakes or deficiencies observed.
(f) Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators and the radiation safety officer, shall be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in § 36.53 that they are expected to perform or comply with, and their proper response to alarms required in this part. Tests may be oral.
(g) Individuals who must be prepared to respond to alarms required by §§ 36.23(b), 36.23(i), 36.27(a), 36.29(a), 36.29(b), and 36.59(b) shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral.
(a) The licensee shall have and follow written operating procedures for—
(1) Operation of the irradiator, including entering and leaving the radiation room;
(2) Use of personnel dosimeters;
(3) Surveying the shielding of panoramic irradiators;
(4) Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas;
(5) Leak testing of sources;
(6) Inspection and maintenance checks required by § 36.61;
(7) Loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and
(8) Inspection of movable shielding required by § 36.23(h), if applicable.
(b) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for—
(1) Sources stuck in the unshielded position;
(2) Personnel overexposures;
(3) A radiation alarm from the product exit portal monitor or pool monitor;
(4) Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water;
(5) A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool;
(6) A prolonged loss of electrical power;
(7) A fire alarm or explosion in the radiation room;
(8) An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area;
(9) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and
(10) The jamming of automatic conveyor systems.
(c) The licensee may revise operating and emergency procedures without Commission approval only if all of the following conditions are met:
(1) The revisions do not reduce the safety of the facility,
(2) The revisions are consistent with the outline or summary of procedures submitted with the license application,
(3) The revisions have been reviewed and approved by the radiation safety officer, and
(4) The users or operators are instructed and tested on the revised procedures before they are put into use.
(a) Irradiator operators shall wear a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter processor must be accredited for high energy photons in the normal and accident dose ranges (see 10 CFR 20.1501(c)). Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be processed at least monthly, and other personnel dosimeters must be processed at least quarterly.
(b) Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within plus or minus 30 percent of the true radiation dose.
(a) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed 3 years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.
(b) If the radiation levels specified in § 36.25 are exceeded, the facility must be modified to comply with the requirements in § 36.25.
(c) Portable radiation survey meters must be calibrated at least annually to an accuracy of ±20 percent for the gamma energy of the sources in use. The calibration must be done at two points on each scale or, for digital instruments, at one point per decade over the range that will be used. Portable radiation survey meters must be of a type that does not saturate and read zero at high radiation dose rates.
(d) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in 10 CFR part 20, table 2, column 2 or table 3 of appendix B, “Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage.”
(e) Before releasing resins for unrestricted use, they must be monitored before release in an area with a background level less than 0.5 microsievert (0.05 millirem) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.5 microsievert (0.05 millirem) per hour.
(a) Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed 6 months using a leak test kit or method approved by the Commission or an Agreement State. In the absence of a certificate from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested. The test must be capable of detecting the presence of 200 becquerels (0.005 microcurie) of radioactive material and must be performed
(b) For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that leak test has been done within the 6 months before the transfer. Water from the pool must be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis must be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.
(c) If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in table 2, column 2, appendix B to part 20. (See 10 CFR 30.50 for reporting requirements.)
(a) The licensee shall perform inspection and maintenance checks that include, as a minimum, each of the following at the frequency specified in the license or license application:
(1) Operability of each aspect of the access control system required by § 36.23.
(2) Functioning of the source position indicator required by § 36.31(b).
(3) Operability of the radiation monitor for radioactive contamination in pool water required by § 36.59(b) using a radiation check source, if applicable.
(4) Operability of the over-pool radiation monitor at underwater irradiators as required by § 36.29(b).
(5) Operability of the product exit monitor required by § 36.29(a).
(6) Operability of the emergency source return control required by § 36.31(c).
(7) Leak-tightness of systems through which pool water circulates (visual inspection).
(8) Operability of the heat and smoke detectors and extinguisher system required by § 36.27 (but without turning extinguishers on).
(9) Operability of the means of pool water replenishment required by § 36.33(c).
(10) Operability of the indicators of high and low pool water levels required by § 36.33(d).
(11) Operability of the intrusion alarm required by § 36.23(i), if applicable.
(12) Functioning and wear of the system, mechanisms, and cables used to raise and lower sources.
(13) Condition of the barrier to prevent products from hitting the sources or source mechanism as required by § 36.35.
(14) Amount of water added to the pool to determine if the pool is leaking.
(15) Electrical wiring on required safety systems for radiation damage.
(16) Pool water conductivity measurements and analysis as required by § 36.63(b).
(b) Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay.
(a) Pool water purification system must be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, the licensee shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences.
(b) The licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters must be calibrated at least annually.
(a) Both an irradiator operator and at least one other individual, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite:
(1) Whenever the irradiator is operated using an automatic product conveyor system; and
(2) Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.
(b) At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, a person who has received the training on how to respond to alarms described in § 36.51(g) must be onsite.
(c) At an underwater irradiator, an irradiator operator must be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they must have received the training described in § 36.51 (f) and (g). Static irradiations may be performed without a person present at the facility.
(a) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.
(b) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall:
(1) Visually inspect the entire radiation room to verify that no one else is in it; and
(2) Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control.
(c) During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by § 36.29(b) is operating with backup power.
(a) Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the Commission. Authorization will not be granted unless the licensee can demonstrate that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel.
(b) Irradiation of more than small quantities of flammable material (flash point below 140 °F) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the Commission. Authorization will not be granted unless the licensee can demonstrate that a fire in the radiation room could be controlled without damage to sealed sources or
The licensee shall maintain the following records at the irradiator for the periods specified.
(a) A copy of the license, license conditions, documents incorporated into a license by reference, and amendments thereto until superseded by new documents or until the Commission terminates the license for documents not superseded.
(b) Records of each individual's training, tests, and safety reviews provided to meet the requirements of § 36.51 (a), (b), (c), (d), (f), and (g) until 3 years after the individual terminates work.
(c) Records of the annual evaluations of the safety performance of irradiator operators required by § 36.51(e) for 3 years after the evaluation.
(d) A copy of the current operating and emergency procedures required by § 36.53 until superseded or the Commission terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by § 36.53(c)(3) retained for 3 years from the date of the change.
(e) Evaluations of personnel dosimeters required by § 36.55 until the Commission terminates the license.
(f) Records of radiation surveys required by § 36.57 for 3 years from the date of the survey.
(g) Records of radiation survey meter calibrations required by § 36.57 and pool water conductivity meter calibrations required by § 36.63(b) until 3 years from the date of calibration.
(h) Records of the results of leak tests required by § 36.59(a) and the results of contamination checks required by § 36.59(b) for 3 years from the date of each test.
(i) Records of inspection and maintenance checks required by § 36.61 for 3 years.
(j) Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for 3 years after repairs are completed.
(k) Records of the receipt, transfer and disposal, of all licensed sealed sources as required by §§ 30.51 and 30.41.
(l) Records on the design checks required by § 36.39 and the construction control checks as required by § 36.41 until the license is terminated. The records must be signed and dated. The title or qualification of the person signing must be included.
(m) Records related to decommissioning of the irradiator as required by § 30.35(g).
(a) In addition to the reporting requirements in other parts of NRC regulations, the licensee shall report the following events if not reported under other parts of NRC regulations:
(1) Source stuck in an unshielded position.
(2) Any fire or explosion in a radiation room.
(3) Damage to the source racks.
(4) Failure of the cable or drive mechanism used to move the source racks.
(5) Inoperability of the access control system.
(6) Detection of radiation source by the product exit monitor.
(7) Detection of radioactive contamination attributable to licensed radioactive material.
(8) Structural damage to the pool liner or walls.
(9) Abnormal water loss or leakage from the source storage pool.
(10) Pool water conductivity exceeding 100 microsiemens per centimeter.
(b) The report must include a telephone report within 24 hours as described in § 30.50(c)(1), and a written report within 30 days as described in § 30.50(c)(2).
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 36 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 36 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 36.1, 36.2, 36.5, 36.8, 36.11, 36.13, 36.17, 36.19, 36.91, and 36.93.
Secs. 53, 57, 62, 63, 65, 69, 81, 82, 161, 182, 183, 186, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
(a) This part prescribes requirements for the issuance of a license authorizing the use of licensed materials including sealed sources, radioactive tracers, radioactive markers, and uranium sinker bars in well logging in a single well. This part also prescribes radiation safety requirements for persons using licensed materials in these operations. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of parts 19, 20, 21, 30, 40, 70, 71, and 150 of this chapter apply to applicants and licensees subject to this part.
(b) The requirements set out in this part do not apply to the issuance of a license authorizing the use of licensed material in tracer studies involving multiple wells, such as field flooding studies, or to the use of sealed sources auxiliary to well logging but not lowered into wells.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S. 3501 et seq.) The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0130.
(b) The approved information collection requirements contained in this part appear in §§ 39.11, 39.13, 39.15, 39.17, 39.31, 39.33, 39.35, 39.37, 39.39, 39.43, 39.51, 39.61, 39.63, 39.65, 39.67, 39.73, 39.75, 39.77, and 39.91.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In § 39.11, NRC Form 313 is approved under control 3150-0120.
(2) [Reserved]
A person, as defined in § 30.4 of this chapter, shall file an application for a specific license authorizing the use of licensed material in well logging on Form NRC 313, “Application for Material License.” Each application for a license, other than a license exempted from part 170 of this chapter, must be accompanied by the fee prescribed in § 170.31 of this chapter. The application must be sent to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter.
The Commission will approve an application for a specific license for the use of licensed material in well logging if the applicant meets the following requirements:
(a) The applicant shall satisfy the general requirements specified in § 30.33 of this chapter for byproduct material, in § 40.32 of this chapter for source material, and in § 70.33 of this chapter for special nuclear material, as appropriate, and any special requirements contained in this part.
(b) The applicant shall develop a program for training logging supervisors and logging assistants and submit to the Commission a description of this program which specifies the—
(1) Initial training;
(2) On-the-job training;
(3) Annual safety reviews provided by the licensee;
(4) Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the Commission's regulations and licensing requirements and the applicant's operating and emergency procedures; and
(5) Means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the applicant's operating and emergency procedures.
(c) The applicant shall submit to the Commission written operating and emergency procedures as described in § 39.63 or an outline or summary of the procedures that includes the important radiation safety aspects of the procedures.
(d) The applicant shall establish and submit to the Commission its program for annual inspections of the job performance of each logging supervisor to ensure that the Commission's regulations, license requirements, and the applicant's operating and emergency procedures are followed. Inspection records must be retained for 3 years after each annual internal inspection.
(e) The applicant shall submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility.
(f) If an applicant wants to perform leak testing of sealed sources, the applicant shall identify the manufacturers and the model numbers of the leak test kits to be used. If the applicant wants to analyze its own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the Commission. The description must include the—
(1) Instruments to be used;
(2) Methods of performing the analysis; and
(3) Pertinent experience of the person who will analyze the wipe samples.
(a) A licensee may perform well logging with a sealed source only after the licensee has a written agreement with the employing well owner or operator. This written agreement must identify who will meet the following requirements:
(1) If a sealed source becomes lodged in the well, a reasonable effort will be made to recover it.
(2) A person may not attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture.
(3) The radiation monitoring required in § 39.69(a) will be performed.
(4) If the environment, any equipment, or personnel are contaminated with licensed material, they must be decontaminated before release from the site or release for unrestricted use; and
(5) If the sealed source is classified as irretrievable after reasonable efforts at recovery have been expended, the following requirements must be implemented within 30 days:
(i) Each irretrievable well logging source must be immobilized and sealed in place with a cement plug.
(ii) A means to prevent inadvertent intrusion on the source, unless the source is not accessible to any subsequent drilling operations; and
(iii) A permanent identification plaque, constructed of long lasting material such as stainless steel, brass, bronze, or monel, must be mounted at the surface of the well, unless the mounting of the plaque is not practical. The size of the plaque must be at least 17 cm [7 inches] square and 3 mm [
(A) The word “CAUTION”;
(B) The radiation symbol (the color requirement in § 20.1901(a) need not be met);
(C) The date the source was abandoned;
(D) The name of the well owner or well operator, as appropriate;
(E) The well name and well identification number(s) or other designation;
(F) An identification of the sealed source(s) by radionuclide and quantity;
(G) The depth of the source and depth to the top of the plug; and
(H) An appropriate warning, such as, “DO NOT RE-ENTER THIS WELL.”
(b) The licensee shall retain a copy of the written agreement for 3 years after the completion of the well logging operation.
(c) A licensee may apply, pursuant to § 39.91, for Commission approval, on a case-by-case basis, of proposed procedures to abandon an irretrievable well logging source in a manner not otherwise authorized in paragraph (a)(5) of this section.
(d) A written agreement between the licensee and the well owner or operator is not required if the licensee and the well owner or operator are part of the same corporate structure or otherwise similarly affiliated. However, the licensee shall still otherwise meet the requirements in paragraphs (a)(1) through (a)(5).
Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the Commission's request, submit written statements, signed under oath or affirmation, to enable the Commission to determine whether or not the license should be modified, suspended, or revoked.
(a)
(2) The licensee may not use a container to store licensed material unless the container has securely attached to it a durable, legible, and clearly visible label. The label must contain the radiation symbol specified in § 20.1901(a) of this chapter and the wording “CAUTION (or DANGER), RADIOACTIVE MATERIAL, NOTIFY CIVIL AUTHORITIES (or NAME OF COMPANY).”
(3) The licensee may not transport licensed material unless the material is packaged, labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in 10 CFR part 71.
(b)
(2) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the vehicle.
(a) The licensee shall keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at each field station and temporary jobsite to make the radiation surveys required by this part and by part 20 of this chapter. To satisfy this requirement, the radiation survey instrument must be capable of measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 mrem) per hour.
(b) The licensee shall have available additional calibrated and operable radiation detection instruments sensitive enough to detect the low radiation and contamination levels that could be encountered if a sealed source ruptured. The licensee may own the instruments
(c) The licensee shall have each radiation survey instrument required under paragraph (a) of this section calibrated—
(1) At intervals not to exceed 6 months and after instrument servicing;
(2) For linear scale instruments, at two points located approximately
(3) So that an accuracy within plus or minus 20 percent of the calibration standard can be demonstrated on each scale.
(d) The licensee shall retain calibration records for a period of 3 years after the date of calibration for inspection by the Commission.
(a)
(b)
(c)
(2) Each ECS that is not exempt from testing in accordance with paragraph (e) of this section must be tested at intervals not to exceed 3 years. In the absence of a certificate from a transferor that a test has been made within the 3 years before the transfer, the ECS may not be used until tested.
(d)
(2) The licensee shall submit a report to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter, within 5 days of receiving the test results. The report must describe the equipment involved in the leak, the test results, any contamination which resulted from the leaking source, and the corrective actions taken up to the time the report is made.
(e)
(1) Hydrogen-3 (tritium) sources;
(2) Sources containing licensed material with a half-life of 30 days or less;
(3) Sealed sources containing licensed material in gaseous form;
(4) Sources of beta- or gamma-emitting radioactive material with an activity of 3.7 MBq [100 microcuries] or less; and
(5) Sources of alpha- or neutron-emitting radioactive material with an activity of 0.37 MBq [10 microcuries] or less.
Each licensee shall conduct a semi-annual physical inventory to account for all licensed material received and possessed under the license. The licensee shall retain records of the inventory for 3 years from the date of the inventory for inspection by the Commission. The inventory must indicate the quantity and kind of licensed material, the location of the licensed material, the date of the inventory, and the name of the individual conducting the inventory. Physical inventory records may be combined with leak test records.
(a) Each licensee shall maintain records for each use of licensed material showing—
(1) The make, model number, and a serial number or a description of each sealed source used;
(2) In the case of unsealed licensed material used for subsurface tracer studies, the radionuclide and quantity of activity used in a particular well and the disposition of any unused tracer materials;
(3) The identity of the logging supervisor who is responsible for the licensed material and the identity of logging assistants present; and
(4) The location and date of use of the licensed material.
(b) The licensee shall make the records required by paragraph (a) of this section available for inspection by the Commission. The licensee shall retain the records for 3 years from the date of the recorded event.
(a) A licensee may use a sealed source for use in well logging applications if —
(1) The sealed source is doubly encapsulated;
(2) The sealed source contains licensed material whose chemical and physical forms are as insoluble and nondispersible as practical; and
(3) Meets the requirements of paragraph (b), (c), or (d) of this section.
(b) For a sealed source manufactured on or before July 14, 1989, a licensee may use the sealed source, for use in well logging applications if it meets the requirements of USASI N5.10-1968, “Classification of Sealed Radioactive Sources,” or the requirements in paragraph (c) or (d) of this section.
(c) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source, for use in well logging applications if it meets the oil-well logging requirements of ANSI/HPS N43.6-1997, “Sealed Radioactive Sources—Classification.”
(d) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source, for use in well logging applications, if—
(1) The sealed source's prototype has been tested and found to maintain its integrity after each of the following tests:
(i)
(ii)
(iii)
(iv)
(v)
(e) The requirements in paragraphs (a), (b), (c), and (d) of this section do not apply to sealed sources that contain licensed material in gaseous form.
(f) The requirements in paragraphs (a), (b), (c), and (d) of this section do not apply to energy compensation sources (ECS). ECSs must be registered with the Commission under § 32.210 of this chapter or with an Agreement State.
(a) Each licensee shall visually check source holders, logging tools, and source handling tools, for defects before each use to ensure that the equipment is in good working condition and that required labeling is present. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing: the date of check, name of inspector, equipment involved, defects found, and repairs made. These records must be retained for 3 years after the defect is found.
(b) Each licensee shall have a program for semiannual visual inspection and routine maintenance of source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars to ensure that the required labeling is legible and that no physical damage is visible. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing: date, equipment involved, inspection and maintenance operations performed, any defects found, and any actions taken to correct the defects. These records must be retained for 3 years after the defect is found.
(c) Removal of a sealed source from a source holder or logging tool, and maintenance on sealed sources or holders in which sealed sources are contained may not be performed by the licensee unless a written procedure developed pursuant to § 39.63 has been approved either by the Commission pursuant to § 39.13(c) or by an Agreement State.
(d) If a sealed source is stuck in the source holder, the licensee may not perform any operation, such as drilling, cutting, or chiseling, on the source holder unless the licensee is specifically approved by the Commission or an Agreement State to perform this operation.
(e) The opening, repair, or modification of any sealed source must be performed by persons specifically approved to do so by the Commission or an Agreement State.
(a) The licensee shall require all personnel handling radioactive tracer material to use protective gloves and, if required by the license, other protective clothing and equipment. The licensee shall take precautions to avoid ingestion or inhalation of radioactive tracer material and to avoid contamination of field stations and temporary jobsites.
(b) A licensee may not knowingly inject licensed material into fresh water aquifers unless specifically authorized to do so by the Commission.
The licensee may use radioactive markers in wells only if the individual markers contain quantities of licensed material not exceeding the quantities specified in § 30.71 of this chapter. The use of markers is subject only to the requirements of § 39.37.
The licensee may use a uranium sinker bar in well logging applications only if it is legibly impressed with the words “CAUTION—RADIOACTIVE-DEPLETED URANIUM” and “NOTIFY CIVIL AUTHORITIES (or COMPANY NAME) IF FOUND.”
The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the source becoming lodged in the well. The procedure must be approved by the Commission pursuant to § 39.13(c) or by an Agreement State.
The licensee may use an energy compensation source (ECS) which is contained within a logging tool, or other tool components, only if the ECS contains quantities of licensed material not exceeding 3.7 MBq [100 microcuries].
(a) For well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only
(b) For well logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of §§ 39.15, 39.35, 39.37, 39.39, 39.51, and 39.77.
(a) Use of a tritium neutron generator target source, containing quantities not exceeding 1,110 MBq [30 curies] and in a well with a surface casing to protect fresh water aquifers, is subject to the requirements of this part except §§ 39.15, 39.41, and 39.77.
(b) Use of a tritium neutron generator target source, containing quantities exceeding 1,110 MBq [30 curies] or in a well without a surface casing to protect fresh water aquifers, is subject to the requirements of this part except § 39.41.
(a) The licensee may not permit an individual to act as a logging supervisor until that person—
(1) Has completed training in the subjects outlined in paragraph (e) of this section;
(2) Has received copies of, and instruction in—
(i) The NRC regulations contained in the applicable sections of parts 19, 20, and 39 of this chapter;
(ii) The NRC license under which the logging supervisor will perform well logging; and
(iii) The licensee's operating and emergency procedures required by § 39.63;
(3) Has completed on-the-job training and demonstrated competence in the use of licensed materials, remote handling tools, and radiation survey instruments by a field evaluation; and
(4) Has demonstrated understanding of the requirements in paragraphs (a) (1) and (2) of this section by successfully completing a written test.
(b) The licensee may not permit an individual to act as a logging assistant until that person—
(1) Has received instruction in applicable sections of parts 19 and 20 of this chapter;
(2) Has received copies of, and instruction in, the licensee's operating and emergency procedures required by § 39.63;
(3) Has demonstrated understanding of the materials listed in paragraphs (b) (1) and (2) of this section by successfully completing a written or oral test; and
(4) Has received instruction in the use of licensed materials, remote handling tools, and radiation survey instruments, as appropriate for the logging assistant's intended job responsibilities.
(c) The licensee shall provide safety reviews for logging supervisors and logging assistants at least once during each calendar year.
(d) The licensee shall maintain a record on each logging supervisor's and logging assistant's training and annual safety review. The training records must include copies of written tests and dates of oral tests given after July 14, 1987. The training records must be retained until 3 years following the termination of employment. Records of annual safety reviews must list the topics discussed and be retained for 3 years.
(e) The licensee shall include the following subjects in the training required in paragraph (a)(1) of this section:
(1) Fundamentals of radiation safety including—
(i) Characteristics of radiation;
(ii) Units of radiation dose and quantity of radioactivity;
(iii) Hazards of exposure to radiation;
(iv) Levels of radiation from licensed material;
(v) Methods of controlling radiation dose (time, distance, and shielding); and
(vi) Radiation safety practices, including prevention of contamination, and methods of decontamination.
(2) Radiation detection instruments including—
(i) Use, operation, calibration, and limitations of radiation survey instruments;
(ii) Survey techniques; and
(iii) Use of personnel monitoring equipment;
(3) Equipment to be used including—
(i) Operation of equipment, including source handling equipment and remote handling tools;
(ii) Storage, control, and disposal of licensed material; and
(iii) Maintenance of equipment.
(4) The requirements of pertinent Federal regulations. And
(5) Case histories of accidents in well logging.
Each licensee shall develop and follow written operating and emergency procedures that cover—
(a) The handling and use of licensed materials including the use of sealed sources in wells without surface casing for protecting fresh water aquifers, if appropriate;
(b) The use of remote handling tools for handling sealed sources and radioactive tracer material except low-activity calibration sources;
(c) Methods and occasions for conducting radiation surveys, including surveys for detecting contamination, as required by § 39.67(c)-(e);
(d) Minimizing personnel exposure including exposures from inhalation and ingestion of licensed tracer materials;
(e) Methods and occasions for locking and securing stored licensed materials;
(f) Personnel monitoring and the use of personnel monitoring equipment;
(g) Transportation of licensed materials to field stations or temporary jobsites, packaging of licensed materials for transport in vehicles, placarding of vehicles when needed, and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss, tampering, or unauthorized removal;
(h) Picking up, receiving, and opening packages containing licensed materials, in accordance with § 20.1906 of this chapter;
(i) For the use of tracers, decontamination of the environment, equipment, and personnel;
(j) Maintenance of records generated by logging personnel at temporary jobsites;
(k) The inspection and maintenance of sealed sources, source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars as required by § 39.43;
(l) Identifying and reporting to NRC defects and noncompliance as required by part 21 of this chapter;
(m) Actions to be taken if a sealed source is lodged in a well;
(n) Notifying proper persons in the event of an accident; and
(o) Actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments as required by § 39.33(b).
(a) The licensee may not permit an individual to act as a logging supervisor or logging assistant unless that person wears, at all times during the handling of licensed radioactive materials, a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor. Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be replaced at least monthly and other personnel dosimeters replaced at least quarterly. After replacement, each personnel dosimeter must be promptly processed.
(b) The licensee shall provide bioassay services to individuals using licensed materials in subsurface tracer studies if required by the license.
(c) The licensee shall retain records of personnel dosimeters required by paragraph (a) of this section and bioassay results for inspection until the Commission authorizes disposition of the records.
(a) The licensee shall make radiation surveys, including but not limited to the surveys required under paragraphs (b) through (e) of this section, of each area where licensed materials are used and stored.
(b) Before transporting licensed materials, the licensee shall make a radiation survey of the position occupied by each individual in the vehicle and of the exterior of each vehicle used to transport the licensed materials.
(c) If the sealed source assembly is removed from the logging tool before departure from the temporary jobsite, the licensee shall confirm that the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter.
(d) If the licensee has reason to believe that, as a result of any operation involving a sealed source, the encapsulation of the sealed source could be damaged by the operation, the licensee shall conduct a radiation survey, including a contamination survey, during and after the operation.
(e) The licensee shall make a radiation survey at the temporary jobsite before and after each subsurface tracer study to confirm the absence of contamination.
(f) The results of surveys required under paragraphs (a) through (e) of this section must be recorded and must include the date of the survey, the name of the individual making the survey, the identification of the survey, instrument used, and the location of the survey. The licensee shall retain records of surveys for inspection by the Commission for 3 years after they are made.
(a) If the licensee detects evidence that a sealed source has ruptured or licensed materials have caused contamination, the licensee shall initiate immediately the emergency procedures required by § 39.63.
(b) If contamination results from the use of licensed material in well logging, the licensee shall decontaminate all work areas, equipment, and unrestricted areas.
(c) During efforts to recover a sealed source lodged in the well, the licensee shall continuously monitor, with an appropriate radiation detection instrument or a logging tool with a radiation detector, the circulating fluids from the well, if any, to check for contamination resulting from damage to the sealed source.
(a) A logging supervisor must be physically present at a temporary jobsite whenever licensed materials are being handled or are not stored and locked in a vehicle or storage place. The logging supervisor may leave the jobsite in order to obtain assistance if a source becomes lodged in a well.
(b) During well logging, except when radiation sources are below ground or in shipping or storage containers, the logging supervisor or other individual designated by the logging supervisor shall maintain direct surveillance of the operation to prevent unauthorized entry into a restricted area, as defined in § 20.1003 of this chapter.
Each licensee shall maintain the following documents and records at the field station:
(a) A copy of parts 19, 20, and 39 of NRC regulations;
(b) The license authorizing the use of licensed material;
(c) Operating and emergency procedures required by § 39.63;
(d) The record of radiation survey instrument calibrations required by § 39.33;
(e) The record of leak test results required by § 39.35;
(f) Physical inventory records required by § 39.37;
(g) Utilization records required by § 39.39;
(h) Records of inspection and maintenance required by § 39.43;
(i) Training records required by § 39.61(d); and
(j) Survey records required by § 39.67.
Each licensee conducting operations at a temporary jobsite shall maintain the following documents and records at the temporary jobsite until the well logging operation is completed:
(a) Operating and emergency procedures required by § 39.63.
(b) Evidence of latest calibration of the radiation survey instruments in use at the site required by § 39.33.
(c) Latest survey records required by §§ 39.67 (b), (c), and (e).
(d) The shipping papers for the transportation of radioactive materials required by § 71.5 of this chapter; and
(e) When operating under reciprocity pursuant to § 150.20 of this chapter, a copy of the Agreement State license authorizing use of licensed materials.
(a) The licensee shall immediately notify the appropriate NRC Regional Office by telephone and subsequently, within 30 days, by confirmatory letter if the licensee knows or has reason to believe that a sealed source has been ruptured. The letter must designate the well or other location, describe the magnitude and extent of the escape of licensed materials, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences.
(b) The licensee shall notify the Commission of the theft or loss of radioactive materials, radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as required by §§ 20.2201-20.2202, § 20.2203 and § 30.50 of this chapter.
(c) If a sealed source becomes lodged in a well, and when it becomes apparent that efforts to recover the sealed source will not be successful, the licensee shall—
(1) Notify the appropriate NRC Regional Office by telephone of the circumstances that resulted in the inability to retrieve the source and—
(i) Obtain NRC approval to implement abandonment procedures; or
(ii) That the licensee implemented abandonment before receiving NRC approval because the licensee believed there was an immediate threat to public health and safety; and
(2) Advise the well owner or operator, as appropriate, of the abandonment procedures under § 39.15 (a) or (c); and
(3) Either ensure that abandonment procedures are implemented within 30 days after the sealed source has been classified as irretrievable or request an extension of time if unable to complete the abandonment procedures.
(d) The licensee shall, within 30 days after a sealed source has been classified as irretrievable, make a report in writing to the appropriate NRC Regional Office. The licensee shall send a copy of the report to each appropriate State or Federal agency that issued permits or otherwise approved of the drilling operation. The report must contain the following information:
(1) Date of occurrence;
(2) A description of the irretrievable well logging source involved including the radionuclide and its quantity, chemical, and physical form;
(3) Surface location and identification of the well;
(4) Results of efforts to immobilize and seal the source in place;
(5) A brief description of the attempted recovery effort;
(6) Depth of the source;
(7) Depth of the top of the cement plug;
(8) Depth of the well;
(9) The immediate threat to public health and safety justification for implementing abandonment if prior NRC approval was not obtained in accordance with paragraph (c)(1)(ii) of this section;
(10) Any other information, such as a warning statement, contained on the permanent identification plaque; and
(11) State and Federal agencies receiving copy of this report.
The Commission may, upon application of any interested person or upon
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 39 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 39 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 39.1, 39.2, 39.5, 39.8, 39.13, 39.91, 39.101, and 39.103.
Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2), 83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274, Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L. 97-415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 193, 104 Stat. 2835, as amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243).
Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
(a) The regulations in this part establish procedures and criteria for the issuance of licenses to receive title to, receive, possess, use, transfer, or deliver source and byproduct materials, as defined in this part, and establish and provide for the terms and conditions upon which the Commission will issue such licenses. (Additional requirements applicable to natural and depleted uranium at enrichment facilities are set forth in § 70.22 of this chapter.) These regulations also provide for the disposal of byproduct material and for the long-term care and custody of byproduct material and residual radioactive material. The regulations in this part also establish certain requirements for the physical protection of import, export, and transient shipments of natural uranium. (Additional requirements applicable to the import and export of natural uranium are set forth in part 110 of this chapter.)
(b) The regulations contained in this part are issued under the Atomic Energy Act of 1954, as amended (68 Stat. 919), title II of the Energy Reorganization Act of 1974, as amended (88 Stat. 1242), and titles I and II of the Uranium Mill Tailings Radiation Control Act of 1978, as amended (42 U.S.C. 7901).
Except as provided in §§ 40.11 to 40.14, inclusive, the regulations in this part apply to all persons in the United States. This part also gives notice to all persons who knowingly provide to any licensee, applicant, contractor, or subcontractor, components, equipment, materials, or other goods or services,
(a) Prior to the completion of the remedial action, the Commission will not require a license pursuant to 10 CFR chapter I for possession of residual radioactive materials as defined in this part that are located at a site where milling operations are no longer active, if the site is covered by the remedial action program of title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended. The Commission will exert its regulatory role in remedial actions primarily through concurrence and consultation in the execution of the remedial action pursuant to title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended. After remedial actions are completed, the Commission will license the long-term care of sites, where residual radioactive materials are disposed, under the requirements set out in § 40.27.
(b) The Commission will regulate byproduct material as defined in this part that is located at a site where milling operations are no longer active, if such site is not covered by the remedial action program of title I of the Uranium Mill Tailings Radiation Control Act of 1978. The criteria in appendix A of this part will be applied to such sites.
A person subject to the regulations in this part may not receive title to, own, receive, possess, use, transfer, provide for long-term care, deliver or dispose of byproduct material or residual radioactive material as defined in this part or any source material after removal from its place of deposit in nature, unless authorized in a specific or general license issued by the Commission under the regulations in this part.
With the exception of “byproduct material” as defined in section 11e. of the Act, other terms defined in section 11 of the Act shall have the same meaning when used in the regulations in this part.
(1) Release of the property for unrestricted use and termination of the license; or
(2) Release of the property under restricted conditions and termination of the license.
(1) Any facility used for separating the isotopes of uranium or enriching uranium in the isotope 235, except laboratory scale facilities designed or used for experimental or analytical purposes only; or
(2) Any equipment or device, or important component part especially designed for such equipment or device, capable of separating the isotopes of uranium or enriching uranium in the isotope 235.
For
(a) Unless otherwise specified or covered under the regional licensing program as provided in paragraph (b) of this section, any communication or report concerning the regulations in this part and any application filed under these regulations may be submitted to the Commission as follows:
(1) By mail addressed to: Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
(2) By delivery in person to the Commission's offices to the Director, Office of Nuclear Material Safety and Safeguards at:
(i) 2120 L Street, NW., Washington, DC; or
(ii) 11545 Rockville Pike, Two White Flint North, Rockville, Maryland.
(b) The Commission has delegated to the five Regional Administrators licensing authority for selected parts of its decentralized licensing program for nuclear materials as described in paragraph (b)(1) of this section. Any communication, report, or application covered under this licensing program must be submitted as specified in paragraph (b)(2) of this section.
(1) The delegated licensing program includes authority to issue, renew, amend, cancel, modify, suspend, or revoke licenses for nuclear materials issued pursuant to 10 CFR parts 30 through 36, 39, 40, and 70 to all persons for academic, medical, and industrial uses, with the following exceptions:
(i) Activities in the fuel cycle and special nuclear material in quantities sufficient to constitute a critical mass in any room or area. This exception does not apply to license modifications relating to termination of special nuclear material licenses that authorize
(ii) Health and safety design review of sealed sources and devices and approval, for licensing purposes, of sealed sources and devices.
(iii) Processing of source material for extracting of metallic compounds (including Zirconium, Hafnium, Tantalum, Titanium, Niobium, etc.).
(iv) Distribution of products containing radioactive material to persons exempt pursuant to 10 CFR 32.11 through 32.26.
(v) New uses or techniques for use of byproduct, source, or special nuclear material.
(vi) Uranium enrichment facilities.
(2)
(ii)
(iii)
(iv)
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
(a) Discrimination by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general
(1) The protected activities include but are not limited to:
(i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of this section or possible violations of requirements imposed under either of those statutes;
(ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer;
(iii) Requesting the Commission to institute action against his or her employer for the administration or enforcement of these requirements;
(iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text.
(v) Assisting or participating in, or is about to assist or participate in, these activities.
(2) These activities are protected even if no formal proceeding is actually initiated as a result of the employee assistance or participation.
(3) This section has no application to any employee alleging discrimination prohibited by this section who, acting without direction from his or her employer (or the employer's agent), deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as amended, or the Atomic Energy Act of 1954, as amended.
(b) Any employee who believes that he or she has been discharged or otherwise discriminated against by any person for engaging in protected activities specified in paragraph (a)(1) of this section may seek a remedy for the discharge or discrimination through an administrative proceeding in the Department of Labor. The administrative proceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Employment Standards Administration, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.
(c) A violation of paragraphs (a), (e), or (f) of this section by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant may be grounds for—
(1) Denial, revocation, or suspension of the license.
(2) Imposition of a civil penalty on the licensee or applicant.
(3) Other enforcement action.
(d) Actions taken by an employer, or others, which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee's engagement in protected activities does not automatically render him or her immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.
(e)(1) Each specific licensee, each applicant for a specific license, and each general licensee subject to part 19 shall prominently post the revision of NRC Form 3, “Notice to Employees”, referenced in 10 CFR 19.11(c).
(2) The posting of NRC Form 3 must be at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted not later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days following license termination.
(3) Copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D to part 20 of this chapter or by calling the NRC Information and Records Management Branch at (301) 415-7230.
(f) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0020.
(b) The approved information collection requirements contained in this part appear in §§ 40.9, 40.23, 40.25, 40.26, 40.27, 40.31, 40.35, 40.36, 40.41, 40.42, 40.43, 40.44, 40.51, 40.60, 40.61, 40.64, 40.65, 40.66, 40.67, and appendix A to this part.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In §§40.31, 40.43, 40.44, and appendix A, NRC Form 313 is approved under control number 3150-0120.
(2) In § 40.31, Form N-71 is approved under control number 3150-0056.
(3) In § 40.42, NRC Form 314 is approved under control number 3150-0028.
(4) In § 40.64, DOE/NRC Form 741 is approved under control number 3150-0003.
(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.
(b) Each applicant or licensee shall notify the Commission of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or undating requirements.
(a) Any licensee, applicant for a license, employee of a licensee or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or applicant for a license, who knowingly provides to any licensee, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's or applicant's activities in this part, may not:
(1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or
(2) Deliberately submit to the NRC, a licensee, an applicant, or a licensee's
(b) A person who violates paragraph (a)(1) or (a)(2) of this section may be subject to enforcement action in accordance with the procedures in 10 CFR part 2, subpart B.
(c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:
(1) Would cause a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or
(2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, applicant, contractor, or subcontractor.
Except to the extent that Department facilities or activities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 or the Uranium Mill Tailings Radiation Control Act of 1978 are involved, any prime contractor of the Department is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the Act and from the regulations in this part to the extent that such contractor, under his prime contract with the Department, receives, possesses, uses, transfers or delivers source material for: (a) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of source material to or from such site and the performance of contract services during temporary interruptions of such transportation; (b) research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or (c) the use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel. In addition to the foregoing exemptions, and subject to the requirement for licensing of Department facilities and activities pursuant to section 202 of the Energy Reorganization Act of 1974 or the Uranium Mill Tailings Radiation Control Act of 1980, any prime contractor or subcontractor of the Department or the Commission is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor receives, possesses, uses, transfers or delivers source material under his prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
(a) Except as specified in paragraph (b) of this section, common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the regulations in this part and the requirements for a license set forth in section 62 of the Act to the extent that they transport or store source material in the regular course of the carriage for another or storage incident thereto.
(b) The exemption in paragraph (a) of this section does not apply to a person who possesses a transient shipment (as defined in § 40.4(r)), an import shipment, or an export shipment of natural uranium in an amount exceeding 500 kilograms, unless the shipment is in the form of ore or ore residue.
(a) Any person is exempt from the regulations in this part and from the requirements for a license set forth in
(b) Any person is exempt from the regulations in this part and from the requirements for a license set forth in section 62 of the act to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided, that, except as authorized in a specific license, such person shall not refine or process such ore.
(c) Any person is exempt from the regulation in this part and from the requirements for a license set forth in section 62 of the Act to the extent that such person receives, possesses, uses, or transfers:
(1) Any quantities of thorium contained in (i) incandescent gas mantles, (ii) vacuum tubes, (iii) welding rods, (iv) electric lamps for illuminating purposes:
(2) Source material contained in the following products:
(i) Glazed ceramic tableware, provided that the glaze contains not more than 20 percent by weight source material;
(ii) Piezoelectric ceramic containing not more than 2 percent by weight source material;
(iii) Glassware containing not more than 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction;
(iv) Glass enamel or glass enamel frit containing not more than 10 percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983.
(3) Photographic film, negatives, and prints containing uranium or thorium;
(4) Any finished product or part fabricated of, or containing tungsten or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4 percent by weight and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such product or part; and
(5) Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights:
(i) The counterweights are manufactured in accordance with a specific license issued by the Commission or the Atomic Energy Commission authorizing distribution by the licensee pursuant to this paragraph;
(ii) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: “Depleted Uranium”;
(iii) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: “Unauthorized Alterations Prohibited”;
(iv) The exemption contained in this paragraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of
(6) Natural or depleted uranium metal used as shielding constituting part of any shipping container:
(i) The shipping container is conspicuously and legibly impressed with the legend “CAUTION—RADIOACTIVE SHIELDING—URANIUM”; and
(ii) The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one-eighth inch (3.2 mm).
(7) Thorium contained in finished optical lenses, provided that each lens does not contain more than 30 percent by weight of thorium; and that the exemption contained in this subparagraph shall not be deemed to authorize either:
(i) The shaping, grinding or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens; or
(ii) The receipt, possession, use, transfer, or of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.
(8) Thorium contained in any finished aircraft engine part containing nickel-thoria alloy,
(i) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and
(ii) The thorium content in the nickel-thoria alloy does not exceed 4 percent by weight.
(9) The exemptions in this paragraph (c) do not authorize the manufacture of any of the products described.
(d) Any person is exempt from the regulations in this part and from the requirements for a license set forth in section 62 of the Act to the extent that such person receives, possesses, uses, or transfers uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie of uranium. The exemption in this paragraph does not authorize the manufacture of any detector head containing uranium.
For
(a) The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulation in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
(b) [Reserved]
(c) The Department of Energy is exempt from the requirements of this part to the extent that its activities are subject to the requirements of part 60 or 63 of this chapter.
(d) Except as specifically provided in part 61 of this chapter any licensee is exempt from the requirements of this part to the extent that its activities are subject to the requirements of part 61 of this chapter.
(a) Licenses for source material and byproduct material are of two types: general and specific. Licenses for long-term care and custody of residual radioactive material at disposal sites are general licenses. The general licenses provided in this part are effective without the filing of applications with the Commission or the issuance of licensing documents to particular persons. Specific licenses are issued to named persons upon applications filed pursuant to the regulations in this part.
(b) Section 40.27 contains a general license applicable for custody and long-term care of residual radioactive material at uranium mill tailings disposal sites remediated under title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended.
(c) Section 40.28 contains a general license applicable for custody and long-term care of byproduct material at
A general license is hereby issued authorizing the receipt of title to source or byproduct material, as defined in this part, without regard to quantity. This general license does not authorize any person to receive, possess, deliver, use, or transfer source or byproduct material.
(a) A general license is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions and Federal, State and local government agencies to use and transfer not more than fifteen (15) pounds of source material at any one time for research, development, educational, commercial or operational purposes. A person authorized to use or transfer source material, pursuant to this general license, may not receive more than a total of 150 pounds of source material in any one calendar year.
(b) Persons who receive, possess, use, or transfer source material pursuant to the general license issued in paragraph (a) of this section are exempt from the provisions of parts 19, 20, and 21, of this chapter to the extent that such receipt, possession, use or transfer are within the terms of such general license:
(c) Persons who receive, possess, use or transfer source material pursuant to the general license in paragraph (a) of this section are prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by NRC in a specific license.
(a) A general license is hereby issued to any person to possess a transient shipment of natural uranium, other than in the form of ore or ore residue, in amounts exceeding 500 kilograms.
(b)(1) Persons generally licensed under paragraph (a) of this section, who plan to carry a transient shipment with scheduled stops at a United States port, shall notify the Division of Industrial and Medical Nuclear Safety, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The notification must be in writing and must be received at least 10 days before transport of the shipment commences at the shipping facility.
(2) The notification must include the following information:
(i) Location of all scheduled stops in United States territory;
(ii) Arrival and departure times for all scheduled stops in United States territory;
(iii) The type of transport vehicle;
(iv) A physical description of the shipment;
(v) The numbers and types of containers;
(vi) The name and telephone number of the carrier's representatives at each stopover location in the United States territory;
(vii) A listing of the modes of shipments, transfer points, and routes to be used;
(viii) The estimated date and time that shipment will commence and that each nation (other than the United States) along the route is scheduled to be entered;
(ix) For shipment between countries that are not party to the Convention on the Physical Protection of Nuclear Material (i.e., not listed in appendix F to part 73 of this chapter), a certification that arrangements have been made to notify the Division of Industrial and Medical Nuclear Safety when
(c) Persons generally licensed under this section making unscheduled stops at United States ports, immediately after the decision to make an unscheduled stop, shall provide to the Division of Industrial and Medical Nuclear Safety the information required under paragraph (b) of this section.
(d) A licensee who needs to amend a notification may do so by telephoning the Division of Industrial and Medical Nuclear Safety at (301) 415-7197.
(a) A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of paragraphs (b), (c), (d), and (e) of this section, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.
(b) The general license in paragraph (a) of this section applies only to industrial products or devices which have been manufactured or initially transferred in accordance with a specific license issued pursuant to § 40.34 (a) of this part or in accordance with a specific license issued by an Agreement State which authorizes manufacture of the products or devices for distribution to persons generally licensed by the Agreement State.
(c)(1) Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by paragraph (a) of this section shall file Form NRC 244, “Registration Certificate—Use of Depleted Uranium Under General License,” with the Director, Division of Industrial and Medical Nuclear Safety, U.S. Nuclear Regulatory Commission, Washington, DC 20555 with a copy to the appropriate NRC Regional Administrator. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium. The registrant shall furnish on Form NRC 244 the following information and such other information as may be required by that form:
(i) Name and address of the registrant;
(ii) A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in paragraph (a) of this section and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and
(iii) Name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in paragraph (c)(1)(ii) of this section.
(2) The registrant possessing or using depleted uranium under the general license established by paragraph (a) of this section shall report in writing to the Director, Division of Industrial and Medical Nuclear Safety, with a copy to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D of part 20 of this chapter, any changes in information furnished by him in the Form NRC 244 “Registration Certificate—Use of Depleted Uranium Under General License.” The report shall be submitted within 30 days after the effective date of such change.
(d) A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by paragraph (a) of this section:
(1) Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.
(2) Shall not abandon such depleted uranium.
(3) Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of § 40.51 of this part. In the case where the transferee receives the depleted uranium pursuant to the general license established by paragraph (a) of
(4) Within 30 days of any transfer, shall report in writing to the Director, Division of Industrial and Medical Nuclear Safety, with a copy to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D of part 20 of this chapter, the name and address of the person receiving the source material pursuant to such transfer.
(e) Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by paragraph (a) of this section is exempt from the requirements of parts 19, 20 and 21 of this chapter with respect to the depleted uranium covered by that general license.
(a) A general license is hereby issued to receive title to, own, or possess byproduct material as defined in this part without regard to form or quantity.
(b) The general license in paragraph (a) of this section applies only: In the case of licensees of the Commission, where activities that result in the production of byproduct material are authorized under a specific license issued by the Commission pursuant to this part, to byproduct material possessed or stored at an authorized disposal containment area or transported incident to such authorized activity:
(c) The general license in paragraph (a) of this section is subject to:
(1) The provisions of parts 19, 20, 21, and §§ 40.1, 40.2a, 40.3, 40.4, 40.5, 40.6, 40.41, 40.46, 40.60, 40.61, 40.62, 40.63, 40.65, 40.71, and 40.81 of part 40 of this chapter; and
(2) The documentation of daily inspections of tailings or waste retention systems and the immediate notification of the appropriate NRC regional office as indicated in appendix D to 10 CFR part 20 of this chapter, or the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, of any failure in a tailings or waste retention system that results in a release of tailings or waste into unrestricted areas, or of any unusual conditions (conditions not contemplated in the design of the retention system) that if not corrected could lead to failure of the system and result in a release of tailings or waste into unrestricted areas; and any additional requirements the Commission may by order deem necessary. The licensee shall retain this documentation of each daily inspection as a record for three years after each inspection is documented.
(d) The general license in paragraph (a) of this section shall expire nine months from the effective date of this subparagraph unless an applicable licensee has submitted, pursuant to the provisions of § 40.31 of this part, an application for license renewal or amendment which includes a detailed program for meeting the technical and financial criteria contained in appendix A of this part.
(a) A general license is issued for the custody of and long-term care, including monitoring, maintenance, and emergency measures necessary to protect public health and safety and other actions necessary to comply with the standards promulgated under section 275(a) of the Atomic Energy Act of 1954, as amended, for disposal sites under title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended. The license is available only to the Department of Energy, or another Federal agency designated by the President to provide long-term care. The purpose of this general license is to ensure that uranium mill tailings disposal sites will be cared for in such a manner as to protect the public health, safety, and the environment after remedial action has been completed.
(b) The general license in paragraph (a) of this section becomes effective when the Commission accepts a site Long-Term Surveillance Plan (LTSP) that meets the requirements of this section, and when the Commission concurs with the Department of Energy's determination of completion of remedial action at each disposal site. There is no termination of this general license. The LTSP may incorporate by reference information contained in documents previously submitted to the Commission if the references to the individual incorporated documents are clear and specific. Each LTSP must include—
(1) A legal description of the disposal site to be licensed, including documentation on whether land and interests are owned by the United States or an Indian tribe. If the site is on Indian land, then, as specified in the Uranium Mill Tailings Radiation Control Act of 1978, as amended, the Indian tribe and any person holding any interest in the land shall execute a waiver releasing the United States of any liability or claim by the Tribe or person concerning or arising from the remedial action and holding the United States harmless against any claim arising out of the performance of the remedial action;
(2) A detailed description, which can be in the form of a reference, of the final disposal site conditions, including existing ground water characterization and any necessary ground water protection activities or strategies. This description must be detailed enough so that future inspectors will have a baseline to determine changes to the site and when these changes are serious enough to require maintenance or repairs. If the disposal site has continuing aquifer restoration requirements, then the licensing process will be completed in two steps. The first step includes all items other than ground water restoration. Ground water monitoring, which would be addressed in the LTSP, may still be required in this first step to assess performance of the tailings disposal units. When the Commission concurs with the completion of ground water restoration, the licensee shall assess the need to modify the LTSP and report results to the Commission. If the proposed modifications meet the requirements of this section, the LTSP will be considered suitable to accommodate the second step.
(3) A description of the long-term surveillance program, including proposed inspection frequency and reporting to the Commission (as specified in appendix A, criterion 12 of this part), frequency and extent of ground water monitoring if required, appropriate constituent concentration limits for ground water, inspection personnel qualifications, inspection procedures, recordkeeping and quality assurance procedures;
(4) The criteria for follow-up inspections in response to observations from routine inspections or extreme natural events; and
(5) The criteria for instituting maintenance or emergency measures.
(c) The long-term care agency under the general license established by paragraph (a) of this section shall—
(1) Implement the LTSP as described in paragraph (b) of this section;
(2) Care for the disposal site in accordance with the provisions of the LTSP;
(3) Notify the Commission of any changes to the LTSP; the changes may
(4) Guarantee permanent right-of-entry to Commission representatives for the purpose of periodic site inspections; and
(5) Notify the Commission prior to undertaking any significant construction, actions, or repairs related to the disposal site, even if the action is required by a State or another Federal agency.
(d) As specified in the Uranium Mill Tailings Radiation Control Act of 1978, as amended, the Secretary of the Interior, with the concurrence of the Secretary of Energy and the Commission, may sell or lease any subsurface mineral rights associated with land on which residual radioactive materials are disposed. In such cases, the Commission shall grant a license permitting use of the land if it finds that the use will not disturb the residual radioactive materials or that the residual radioactive materials will be restored to a safe and environmentally sound condition if they are disturbed by the use.
(e) The general license in paragraph (a) of this section is exempt from parts 19, 20, and 21 of this chapter, unless significant construction, actions, or repairs are required. If these types of actions are to be undertaken, the licensee shall explain to the Commission which requirements from these parts apply for the actions and comply with the appropriate requirements.
(a) A general license is issued for the custody of and long-term care, including monitoring, maintenance, and emergency measures necessary to protect the public health and safety and other actions necessary to comply with the standards in this part for uranium or thorium mill tailings sites closed under title II of the Uranium Mill Tailings Radiation Control Act of 1978, as amended. The licensee will be the Department of Energy, another Federal agency designated by the President, or a State where the disposal site is located. The purpose of this general license is to ensure that uranium and thorium mill tailings disposal sites will be cared for in such a manner as to protect the public health, safety, and the environment after closure.
(b) The general license in paragraph (a) of this section becomes effective when the Commission terminates, or concurs in an Agreement State's termination of, the current specific license and a site Long-Term Surveillance Plan (LTSP) meeting the requirements of this section has been accepted by the Commission. There is no termination of this general license. If the LTSP has not been formally received by the NRC prior to termination of the current specific license, the Commission may issue a specific order to the intended custodial agency to ensure continued control and surveillance of the disposal site to protect the public health, safety, and the environment. The Commission will not unnecessarily delay the termination of the specific license solely on the basis that an acceptable LTSP has not been received. The LTSP may incorporate by reference information contained in documents previously submitted to the Commission if the references to the individual incorporated documents are clear and specific. Each LTSP must include—
(1) A legal description of the disposal site to be transferred (unless transfer is exempted under provisions of the Atomic Energy Act, § 83(b)(1)(A)) and licensed;
(2) A detailed description, which can be in the form of a reference of the final disposal site conditions, including existing ground water characterization. This description must be detailed enough so that future inspectors will have a baseline to determine changes to the site and when these changes are serious enough to require maintenance or repairs;
(3) A description of the long-term surveillance program, including proposed inspection frequency and reporting to the Commission (as specified in appendix A, Criterion 12 of this part), frequency and extent of ground water monitoring if required, appropriate constituent concentration limits for ground water, inspection personnel qualifications, inspection procedures,
(4) The criteria for follow-up inspections in response to observations from routine inspections or extreme natural events; and
(5) The criteria for instituting maintenance or emergency measures.
(c) The long-term care agency who has a general license established by paragraph (a) of this section shall—
(1) Implement the LTSP as described in paragraph (b) of this section;
(2) Care for the disposal site in accordance with the provisions of the LTSP;
(3) Notify the Commission of any changes to the LTSP; the changes may not conflict with the requirements of this section;
(4) Guarantee permanent right-of-entry to Commission representatives for the purpose of periodic site inspections; and
(5) Notify the Commission prior to undertaking any significant construction, actions, or repairs related to the disposal site, even if the action is required by a State or another Federal agency.
(d) Upon application, the Commission may issue a specific license, as specified in the Uranium Mill Tailings Radiation Control Act of 1978, as amended, permitting the use of surface and/or subsurface estates transferred to the United States or a State. Although an application may be received from any person, if permission is granted, the person who transferred the land to DOE or the State shall receive the right of first refusal with respect to this use of the land. The application must demonstrate that—
(1) The proposed action does not endanger the public health, safety, welfare, or the environment;
(2) Whether the proposed action is of a temporary or permanent nature, the site would be maintained and/or restored to meet requirements in appendix A of this part for closed sites; and
(3) Adequate financial arrangements are in place to ensure that the byproduct materials will not be disturbed, or if disturbed that the applicant is able to restore the site to a safe and environmentally sound condition.
(e) The general license in paragraph (a) of this section is exempt from parts 19, 20, and 21 of this chapter, unless significant construction, actions, or repairs are required. If these types of actions are to be undertaken, the licensee shall explain to the Commission which requirements from these parts apply for the actions and comply with the appropriate requirements.
(f) In cases where the Commission determines that transfer of title of land used for disposal of any byproduct materials to the United States or any appropriate State is not necessary to protect the public health, safety or welfare or to minimize or eliminate danger to life or property (Atomic Energy Act, § 83(b)(1)(A)), the Commission will consider specific modifications of the custodial agency's LTSP provisions on a case-by-case basis.
(a) A person may file an application for specific license in duplicate on NRC Form 313, “Application for Material License,” in accordance with the instructions in § 40.5 of this chapter. Information contained in previous applications, statements or reports filed with the Commission may be incorporated by reference provided that the reference is clear and specific.
(b) The Commission may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Commission to determine whether the application should be granted or denied or whether a license should be modified or revoked. All applications and statements shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.
(c) Applications and documents submitted to the Commission in connection with applications will be made available for public inspection in accordance with the provisions of the regulations contained in parts 2 and 9 of this chapter.
(d) An application for a license filed pursuant to the regulations in this part
(e) Each application for a source material license, other than a license exempted from part 170 of this chapter, shall be accompanied by the fee prescribed in § 170.31 of this chapter. No fee will be required to accompany an application for renewal or amendment of a license, except as provided in § 170.31 of this chapter.
(f) An application for a license to possess and use source material for uranium milling, production of uranium hexafluoride, or for the conduct of any other activity which the Commission has determined pursuant to subpart A of part 51 of this chapter will significantly affect the quality of the environment shall be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any Environmental Report required pursuant to subpart A of part 51 of this chapter.
(g) In response to a written request by the Commission, an applicant for a license to possess and use source material in a uranium hexafluoride production plant or a fuel fabrication plant and any other applicant for a license to possess and use more than one effective kilogram of source material (except for ore processing, as defined in § 75.4(o) of this chapter) shall file with the Commission the installation information described in § 75.11 of this chapter, on Form N-71. The applicant shall also permit verification of this installation information by the International Atomic Energy Agency and take other action as may be necessary to implement the US/IAEA Safeguards Agreement, in the manner set forth § 75.6 and §§ 75.11 through 75.14 of this chapter.
(h) An application for a license to receive, possess, and use source material for uranium or thorium milling or byproduct material, as defined in this part, at sites formerly associated with such milling shall contain proposed written specifications relating to milling operations and the disposition of the byproduct material to achieve the requirements and objectives set forth in appendix A of this part. Each application must clearly demonstrate how the requirements and objectives set forth in appendix A of this part have been addressed. Failure to clearly demonstrate how the requirements and objectives in appendix A have been addressed shall be grounds for refusing to accept an application.
(i) As provided by § 40.36, certain applications for specific licenses filed under this part must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning. In the case of renewal applications submitted before July 27, 1990, this submittal may follow the renewal application but must be submitted on or before July 27, 1990.
(j)(1) Each application to possess uranium hexafluoride in excess of 50 kilograms in a single container or 1000 kilograms total must contain either:
(i) An evaluation showing that the maximum intake of uranium by a member of the public due to a release would not exceed 2 milligrams; or
(ii) An emergency plan for responding to the radiological hazards of an accidental release of source material and to any associated chemical hazards directly incident thereto.
(2) One or more of the following factors may be used to support an evaluation submitted under paragraph (j)(1)(i) of this section:
(i) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;
(ii) Facility design or engineered safety features in the facility would reduce the amount of the release; or
(iii) Other factors appropriate for the specific facility.
(3) An emergency plan submitted under paragraph (j)(1)(ii) of this section must include the following:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
(x)
(xi)
(xii)
(xiii)
(4) The licensee shall allow the offsite response organizations expected to
(k) A license application for a uranium enrichment facility must be accompanied by an Environmental Report required under subpart A of part 51 of this chapter.
(l) A license application that involves the use of source material in a uranium enrichment facility must include the applicant's provisions for liability insurance.
An application for a specific license will be approved if:
(a) The application is for a purpose authorized by the Act; and
(b) The applicant is qualified by reason of training and experience to use the source material for the purpose requested in such manner as to protect health and minimize danger to life or property; and
(c) The applicant's proposed equipment, facilities and procedures are adequate to protect health and minimize danger to life or property; and
(d) The issuance of the license will not be inimical to the common defense and security or to the health and safety of the public; and
(e) In the case of an application for a license for a uranium enrichment facility, or for a license to possess and use source and byproduct material for uranium milling, production of uranium hexafluoride, or for the conduct of any other activity which the Commission determines will significantly affect the quality of the environment, the Director of Nuclear Material Safety and Safeguards or his designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to this conclusion is grounds for denial of a license to possess and use source and byproduct material in the plant or facility. As used in this paragraph, the term “commencement of construction” means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, roads necessary for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.
(f) The applicant satisfies any applicable special requirements contained in § 40.34.
(g) If the proposed activity involves use of source material in a uranium enrichment facility, the applicant has satisfied the applicable provisions of part 140 of this chapter.
(a) The Commission will hold a hearing pursuant to 10 CFR part 2, subparts A, G, and I, on each application with regard to the licensing of the construction and operation of a uranium enrichment facility. The Commission will publish public notice of the hearing in the
(b) A license for a uranium enrichment facility may not be issued before the hearing is completed and a decision issued on the application.
(a) An application for a specific license to manufacture industrial products and devices containing depleted uranium, or to initially transfer such products or devices, for use pursuant to § 40.25 of this part or equivalent regulations of an Agreement State, will be approved if:
(1) The applicant satisfies the general requirements specified in § 40.32;
(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in 1 year a radiation dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter; and
(3) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
(b) In the case of an industrial product or device whose unique benefits are questionable, the Commission will approve an application for a specific license under this paragraph only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.
(c) The Commission may deny an applicant for a specific license under this paragraph if the end uses of the industrial product or device cannot be reasonably foreseen.
Each person licensed pursuant to § 40.34 shall:
(a) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;
(b) Label or mark each unit to: (1) Identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and (2) state that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. NRC or of an Agreement State;
(c) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: “Depleted Uranium”;
(d)(1) Furnish a copy of the general license contained in § 40.25 and a copy of Form NRC 244 to each person to whom he transfers source material in a product or device for use pursuant to the general license contained in § 40.25; or
(2) Furnish a copy of the general license contained in the Agreement State's regulation equivalent to § 40.25 and a copy of the Agreement State's certificate, or alternately, furnish a copy of the general license contained in § 40.25 and a copy of Form NRC 244 to each person to whom he transfers source material in a product or device for use pursuant to the general license of an Agreement State. If a copy of the general license in § 40.25 and a copy of Form NRC 244 are furnished to such person, they shall be accompanied by a note explaining that use of the product or device is regulated by the Agreement State under requirements substantially the same as those in § 40.25; and
(e)(1) Report to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, all
(2) Report to the responsible Agreement State Agency all transfers of industrial products or devices to persons for use under the general license in the Agreement State's regulation equivalent to § 40.25. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. If no transfers have been made to a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State Agency;
(3) Keep records showing the name, address, and a point of contact for each general license to whom he or she transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in § 40.25 or equivalent regulations of an Agreement State. The records must be retained for three years from the date of transfer and must show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.
(f) Licensees required to submit emergency plans by § 40.31(i) shall follow the emergency plan approved by the Commission. The licensee may change the plan without Commission approval if the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555 and to affected offsite response organizations within six months after the change is made. Proposed changes that decrease the effectiveness of the approved emergency plan may not be implemented without application to and prior approval by the Commission.
Except for licenses authorizing the receipt, possession, and use of source material for uranium or thorium milling, or byproduct material at sites formerly associated with such milling, for which financial assurance requirements are set forth in appendix A of this part, criteria for providing financial assurance for decommissioning are as follows:
(a) Each applicant for a specific license authorizing the possession and use of more than 100 mCi of source material in a readily dispersible form shall submit a decommissioning funding plan as described in paragraph (d) of this section.
(b) Each applicant for a specific license authorizing possession and use of quantities of source material greater than 10 mCi but less than or equal to 100 mCi in a readily dispersible form shall either—
(1) Submit a decommissioning funding plan as described in paragraph (d) of this section; or
(2) Submit a certification that financial assurance for decommissioning has been provided in the amount of $150,000 using one of the methods described in paragraph (e) of this section. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If
(c)(1) Each holder of a specific license issued on or after July 27, 1990, which is covered by paragraph (a) or (b) of this section, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section.
(2) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (a) of this section shall submit, on or before July 27, 1990, a decommissioning funding plan as described in paragraph (d) of this section or a certification of financial assurance for decommissioning in an amount at least equal to $750,000 in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in any application for license renewal.
(3) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (b) of this section shall submit, on or before July 27, 1990, a decommissioning funding plan, as described in paragraph (d) of this section, or a certification of financial assurance for decommissioning in accordance with the criteria set forth in this section.
(4) Any licensee who has submitted an application before July 27, 1990, for renewal of license in accordance with § 40.43 shall provide financial assurance for decommissioning in accordance with paragraphs (a) and (b) of this section. This assurance must be submitted when this rule becomes effective November 24, 1995.
(d) Each decommissioning funding plan must contain a cost estimate for decommissioning and a description of the method of assuring funds for decommissioning from paragraph (e) of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility. The decommissioning funding plan must also contain a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning and a signed original of the financial instrument obtained to satisfy the requirements of paragraph (e) of this section.
(e) Financial assurance for decommissioning must be provided by one or more of the following methods:
(1)
(2)
(i) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the Commission, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Commission within 30 days after receipt of notification of cancellation.
(ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Commission. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.
(iii) The surety method or insurance must remain in effect until the Commission has terminated the license.
(3) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provision must be as stated in paragraph (e)(2) of this section.
(4) In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on paragraph (b) of this section, and indicating that funds for decommissioning will be obtained when necessary.
(5) When a government entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such government entity.
(f) Each person licensed under this part shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with § 40.41(b) licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the Commission considers important to decommissioning consists of—
(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.
(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each
(3) Except for areas containing depleted uranium used only for shielding or as penetrators in unused munitions, a list contained in a single document and updated every 2 years, of the following:
(i) All areas designated and formerly designated as restricted areas as defined under 10 CFR 20.1003;
(ii) All areas outside of restricted areas that require documentation under § 40.36(f)(1);
(iii) All areas outside of restricted areas where current and previous wastes have been buried as documented under 10 CFR 20.2108; and
(iv) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 10 CFR part 20, subpart E, or apply for approval for disposal under 10 CFR 20.2002.
(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.
A license may not be issued to the Corporation if the Commission determines that:
(a) The Corporation is owned, controlled, or dominated by an alien, a foreign corporation, or a foreign government; or
(b) The issuance of such a license would be inimical to—
(1) The common defense and security of the United States; or
(2) The maintenance of a reliable and economical domestic source of enrichment services.
(a) Each license issued pursuant to the regulations in this part shall be subject to all the provisions of the act, now or hereafter in effect, and to all rules, regulations and orders of the Commission.
(b) Neither the license nor any right under the license shall be assigned or otherwise transferred in violation of the provisions of the Act.
(c) Each person licensed by the Commission pursuant to the regulations in this part shall confine his possession and use of source or byproduct material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the regulations in this part shall carry with it the right to receive, possess, and use source or byproduct material. Preparation for shipment and transport of source or byproduct material shall be in accordance with the provisions of part 71 of this chapter.
(d) Each license issued pursuant to the regulations in this part shall be deemed to contain the provisions set forth in sections 183b.-d., of the Act, whether or not said provisions are expressly set forth in the license.
(e) The Commission may incorporate in any license at the time of issuance, or thereafter, by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of source or byproduct material as it deems appropriate or necessary in order to:
(1) Promote the common defense and security;
(2) Protect health or to minimize danger of life or property;
(3) Protect restricted data;
(4) Require such reports and the keeping of such records, and to provide for such inspections of activities under
(f)(1) Each licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against:
(i) The licensee;
(ii) An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or
(iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.
(2) This notification must indicate:
(i) The bankruptcy court in which the petition for bankruptcy was filed; and
(ii) The date of the filing of the petition.
(g) No person may commence operation of a uranium enrichment facility until the Commission verifies through inspection that the facility has been constructed in accordance with the requirements of the license. The Commission shall publish notice of the inspection results in the
(a)(1) Except as provided in paragraph (a)(2) of this section, each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under § 40.43 not less than 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph). If an application for renewal has been filed at least 30 days before the expiration date stated in the existing license (or, for those licenses subject to paragraph (a)(2) of this section, 30 days before the deemed expiration date in that paragraph), the existing license expires at the end of the day on which the Commission makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.
(2) Each specific license that has an expiration date after July 1, 1995, and is not one of the licenses described in paragraph (a)(3) of this section, shall be deemed to have an expiration date that is five years after the expiration date stated in the current license.
(3) The following specific licenses are not subject to, or otherwise affected by, the provisions of paragraph (a)(2) of this section:
(i) Specific licenses for which, on February 15, 1996, an evaluation or an emergency plan is required in accordance with § 40.31(j);
(ii) Specific licenses whose holders are subject to the financial assurance requirements specified in 10 CFR 40.36, and on February 15, 1996, the holders either:
(A) Have not submitted a decommissioning funding plan nor certification of financial assurance for decommissioning; or
(B) Have not received written notice that the decommissioning funding plan or certification of financial assurance for decommissioning is acceptable;
(iii) Specific licenses whose holders are listed in the SDMP List published in NUREG 1444, Supplement 1 (November 1995);
(iv) Specific licenses whose issuance, amendment, or renewal, as of February 15, 1996, is not a categorical exclusion under 10 CFR 51.22(c)(14) and, therefore, need an environmental assessment or environmental impact statement pursuant to subpart A of part 51 of this chapter;
(v) Specific licenses whose holders have not had at least one NRC inspection of licensed activities before February 15, 1996;
(vi) Specific licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before February 15, 1996, have been:
(A) Cited for a Severity Level I, II, or III violation in a Notice of Violation;
(B) Subject to an Order issued by the NRC; or
(C) Subject to a CAL issued by the NRC.
(vii) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under 10 CFR 40.43 of this part.
(b) Each specific license revoked by the Commission expires at the end of the day on the date of the Commission's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Commission Order.
(c) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of source material until the Commission notifies the licensee in writing that the license is terminated. During this time, the licensee shall—
(1) Limit actions involving source material to those related to decommissioning; and
(2) Continue to control entry to restricted areas until they are suitable for release in accordance with NRC requirements;
(d) Within 60 days of the occurrence of any of the following, consistent with the administrative directions in § 40.5, each licensee shall provide notification to the NRC in writing and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity, so that the building or outdoor area is suitable for release in accordance with NRC requirements, or submit within 12 months of notification a decommissioning plan, if required by paragraph (g)(1) of this section, and begin decommissioning upon approval of that plan if—
(1) The license has expired pursuant to paragraph (a) or (b) of this section; or
(2) The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area; or
(3) No principal activities under the license have been conducted for a period of 24 months; or
(4) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with NRC requirements.
(e) Coincident with the notification required by paragraph (d) of this section, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to § 40.36 in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to paragraph (g)(4)(v) of this section.
(1) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this rule becomes effective November 24, 1995.
(2) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Commission.
(f) The Commission may grant a request to delay or postpone initiation of the decommissioning process if the Commission determines that such relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to paragraph (d) of this section. The schedule for decommissioning set forth in paragraph (d) of this section may not commence until the Commission has made a determination on the request.
(g)(1) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Commission and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:
(i) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;
(ii) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;
(iii) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or
(iv) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.
(2) The Commission may approve an alternate schedule for submittal of a decommissioning plan required pursuant to paragraph (d) of this section if the Commission determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.
(3) The procedures listed in paragraph (g)(1) of this section may not be carried out prior to approval of the decommissioning plan.
(4) The proposed decommissioning plan for the site or separate building or outdoor area must include:
(i) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;
(ii) A description of planned decommissioning activities;
(iii) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;
(iv) A description of the planned final radiation survey; and
(v) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.
(vi) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay based on the criteria in paragraph (i) of this section.
(5) The proposed decommissioning plan will be approved by the Commission if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.
(h)(1) Except as provided in paragraph (i) of this section, licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of decommissioning.
(2) Except as provided in paragraph (i) of this section, when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.
(i) The Commission may approve a request for an alternate schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Commission determines that the alternative is warranted by consideration of the following:
(1) Whether it is technically feasible to complete decommissioning within the allotted 24-month period;
(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;
(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;
(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and
(5) Other site-specific factors which the Commission may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.
(j) As the final step in decommissioning, the licensee shall—
(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed NRC Form 314 or equivalent information; and
(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E or, for uranium milling (uranium and thorium recovery) facilities, Criterion 6(6) of Appendix A to this part. The licensee shall, as appropriate—
(i) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per 100 square centimeters removable and fixed for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and
(ii) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.
(k) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Commission determines that:
(1) Source material has been properly disposed;
(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and
(3)(i) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E or, for (uranium and thorium recovery) facilities, Criterion 6(6) of Appendix A to this part; or
(ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E or, for uranium milling (uranium and thorium recovery) facilities, Criterion 6(6) of Appendix A to this part.
(4) Records required by § 40.61 (d) and (f) have been received.
(l) Specific licenses for uranium and thorium milling are exempt from paragraphs (d)(4), (f) and (g) of this section with respect to reclamation of tailings impoundments and/or waste disposal areas.
(a) Application for renewal of a specific license must be filed on NRC Form 313 and in accordance with § 40.31.
(b) If any licensee granted the extension described in 10 CFR 40.42(a)(2) has a currently pending renewal application for the extended license, that application will be considered to be withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded.
Applications for amendment of a license shall be filed on NRC Form 313 in accordance with § 40.31 and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.
In considering an application by a licensee to renew or amend his license the Commission will apply the applicable criteria set forth in § 40.32.
No license issued or granted pursuant to the regulations in this part shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly,
(a) No licensee shall transfer source or byproduct material except as authorized pursuant to this section.
(b) Except as otherwise provided in his license and subject to the provisions of paragraphs (c) and (d) of this section, any licensee may transfer source or byproduct material:
(1) To the Department of Energy;
(2) To the agency in any Agreement State which regulates radioactive materials pursuant to an agreement with the Commission or the Atomic Energy Commission under section 274 of the Act;
(3) To any person exempt from the licensing requirements of the Act and regulations in this part, to the extent permitted under such exemption;
(4) To any person in an Agreement State subject to the jurisdiction of that State who has been exempted from the licensing requirements and regulations of that State, to the extent permitted under such exemptions;
(5) To any person authorized to receive such source or byproduct material under terms of a specific license or a general license or their equivalents issued by the Commission or an Agreement State;
(6) To any person abroad pursuant to an export license issued under part 110 of this chapter; or
(7) As otherwise authorized by the commission in writing.
(c) Before transferring source or byproduct material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State prior to receipt of the source or byproduct material, the licensee transferring the material shall verify that the transferee's license authorizes receipt of the type, form, and quantity of source or byproduct material to be transferred.
(d) The following methods for the verification required by paragraph (c) of this section are acceptable:
(1) The transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate;
(2) The transferor may have in his possession a written certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of source or byproduct material to be transferred, specifying the license or registration certification number, issuing agency and expiration date;
(3) For emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of source or byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date:
(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registrations; or
(5) When none of the methods of verification described in paragraphs (d)(1) to (4) of this section are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the source or byproduct material.
(a)
(b)
(1) An unplanned contamination event that:
(i) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;
(ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and
(iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.
(2) An event in which equipment is disabled or fails to function as designed when:
(i) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;
(ii) The equipment is required to be available and operable when it is disabled or fails to function; and
(iii) No redundant equipment is available and operable to perform the required safety function.
(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.
(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:
(i) The quantity of material involved is greater than five times the lowest annual limit on intake specified in appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and
(ii) The damage affects the integrity of the licensed material or its container.
(c)
(1) Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operations Center.
(i) The caller's name and call back telephone number;
(ii) A description of the event, including date and time;
(iii) The exact location of the event;
(iv) The isotopes, quantities, and chemical and physical form of the licensed material involved; and
(v) Any personnel radiation exposure data available.
(2)
(i) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;
(ii) The exact location of the event;
(iii) The isotopes, quantities, and chemical and physical form of the licensed material involved;
(iv) Date and time of the event;
(v) Corrective actions taken or planned and the results of any evaluations or assessments; and
(vi) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.
(3) The provisions of § 40.60 do not apply to licensees subject to the notification requirements in § 50.72. They do apply to those part 50 licensees possessing material licensed under part 40 who are not subject to the notification requirements in § 50.72.
(a) Each person who receives source or byproduct material pursuant to a license issued pursuant to the regulations in this part shall keep records showing the receipt, transfer, and disposal of this source or byproduct material as follows:
(1) The licensee shall retain each record of receipt of source or byproduct material as long as the material is possessed and for three years following transfer or disposition of the source or byproduct material.
(2) The licensee who transferred the material shall retain each record of transfer or source or byproduct material until the Commission terminates each license that authorizes the activity that is subject to the recordkeeping requirement.
(3) The licensee shall retain each record of disposal of source or byproduct material until the Commission terminates each license that authorizes the activity that is subject to the recordkeeping requirement.
(4) If source or byproduct material is combined or mixed with other licensed material and subsequently treated in a manner that makes direct correlation of a receipt record with a transfer, export, or disposition record impossible, the licensee may use evaluative techniques (such as first-in-first-out), to make the records that are required by this part account for 100 percent of the material received.
(b) The licensee shall retain each record that is required by the regulations in this part or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, each record must be maintained until the Commission terminates the license that authorizes the activity that is subject to the recordkeeping requirement.
(c)(1) Records which must be maintained pursuant to this part may be the original or reproduced copy or microform if the reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(2) If there is a conflict between the Commission's regulations in this part, license condition, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this part for such records shall apply unless the Commission, pursuant to § 40.14 of this part, has granted a specific exemption from the record retention requirements specified in the regulations in this part.
(d) Prior to license termination, each licensee authorized to possess source material, in an unsealed form, shall forward the following records to the appropriate NRC Regional Office:
(1) Records of disposal of licensed material made under § 20.2002 (including burials authorized before January 28, 1981
(2) Records required by § 20.2103(b)(4).
(e) If licensed activities are transferred or assigned in accordance with § 40.41(b), each licensee authorized to possess source material, in an unsealed form, shall transfer the following
(1) Records of disposal of licensed material made under § 20.2002 (including burials authorized before January 28, 1981
(2) Records required by § 20.2103(b)(4).
(f) Prior to license termination, each licensee shall forward the records required by § 40.36(f) to the appropriate NRC Regional Office.
(a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect source or byproduct material and the premises and facilities wherein source or byproduct material is used or stored.
(b) Each licensee shall make available to the Commission for inspection, upon reasonable notice, records kept by him pursuant to the regulations in this chapter.
Each licensee shall perform, or permit the Commission to perform, such tests as the Commission deems appropriate or necessary for the administration of the regulations in this part, including tests of:
(a) Source or byproduct material;
(b) Facilities wherein source or byproduct material is utilized or stored;
(c) Radiation detection and monitoring instruments; and
(d) Other equipment and devices used in connection with the utilization and storage of source or byproduct material.
(a) Except as specified in paragraphs (d) and (e) of this section, each specific licensee who transfers, receives, or adjusts the inventory, in any manner, of uranium or thorium source material of foreign origin by 1 kilogram or more or who imports or exports 1 kilogram of uranium or thorium source material of any origin shall complete a Nuclear Material Transaction Report in computer-readable format in accordance with instructions (NUREG/BR-0006 and NMMSS Report D-24 “Personal Computer Data Input for NRC Licensees”). Copies of the instructions may be obtained from the U.S. Nuclear Regulatory Commission, Division of Fuel Cycle Safety and Safeguards, Washington, DC 20555-0001. Each licensee who transfers the material shall submit a Nuclear Material Transaction Report in computer-readable format in accordance with instructions no later than the close of business the next working day. Each licensee who receives the material shall submit a Nuclear Material Transaction Report in computer-readable format in accordance with instructions within ten (10) days after the material is received. The Commission's copy of the report must be submitted to the address specified in the instructions. These prescribed computer-readable forms replace the DOE/NRC Form 741 which has been previously submitted in paper form.
(b) Except as specified in paragraphs (d) and (e) of this section, each licensee authorized to possess at any one time and location more than 1,000 kilograms of uranium or thorium, or any combination of uranium or thorium, shall submit to the Commission within 30 days after September 30 of each year a statement of its foreign origin source material inventory. This statement must be submitted to the address specified in the reporting instructions (NUREG/BR-0007), and include the Reporting Identification Symbol (RIS) assigned by the Commission to the licensee. Copies of the reporting instructions may be obtained by writing to the U.S. Nuclear Regulatory Commission, Division of Safeguards and Transportation, Washington, DC 20555.
(c) Except as specified in paragraph (d) of this section, each licensee who is authorized to possess uranium or thorium pursuant to a specific license shall report promptly to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter by telephone and telegraph, mailgram, or facsimile any incident in which an attempt has been made or is believed to have been made to commit a theft or unlawful diversion of more than 15
(d) The reports described in paragraphs (a), (b), and (c) of this section are not required for:
(1) Processed ores containing less than five (5) percent of uranium or thorium, or any combination of uranium or thorium, by dry weight;
(2) Thorium contained in magnesium-thorium and tungsten-thorium alloys, if the thorium content in the alloys does not exceed 4 percent by weight;
(3) Chemical catalysts containing uranium depleted in the U-235 isotope to 0.4 percent or less, if the uranium content of the catalyst does not exceed 15 percent by weight; or
(4) Any source material contained in non-nuclear end use devices or components, including but not limited to permanently installed shielding, teletherapy, radiography, X-ray, accelerator devices, or munitions.
(e) Any licensee who is required to submit inventory change reports and material status reports pursuant to part 75 of this chapter (pertaining to implementation of the US/IAEA Safeguards Agreement) shall prepare and submit such reports only as provided in §§ 75.34 and 75.35 of this chapter (instead of as provided in paragraphs (a) and (b) of this section).
(a) Each licensee authorized to possess and use source material in uranium milling, in production of uranium hexafluoride, or in a uranium enrichment facility shall:
(1) Submit a report to the appropriate NRC Regional Office shown in appendix D of part 20 of this chapter, with copies to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, within 60 days after January 1, 1976 and July 1, 1976, and within 60 days after January 1 and July 1 of each year thereafter, specifying the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in gaseous effluents during the previous six months of operation, and such other information the Commission may require to estimate maximum potential annual radiation doses to the public resulting from effluent releases. If quantities of radioactive materials released during the reporting period are significantly above the licensee's design objectives previously reviewed as part of the licensing action, the report shall cover this specifically. On the basis of such reports and any additional information the Commission may obtain from the licensee or others, the Commission may from time to time require the licensee to take such action as the Commission deems appropriate.
(2) [Reserved]
(b) [Reserved]
(a) Each licensee authorized to export natural uranium, other than in the form of ore or ore residue, in amounts exceeding 500 kilograms, shall notify the Division of Industrial and Medical Nuclear Safety, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
The notification must be in writing and must be received at least 10 days before transport of the shipment commences at the shipping facility.
(b) The notification must include the following information:
(1) The name(s), address(es), and telephone number(s) of the shipper, receiver, and carrier(s);
(2) A physical description of the shipment;
(3) A listing of the mode(s) of shipment, transfer points, and routes to be used;
(4) The estimated date and time that shipment will commence and that each nation (other than the United States) along the route is scheduled to be entered; and
(5) A certification that arrangements have been made to notify the Division of Industrial and Medical Nuclear Safety when the shipment is received at the receiving facility.
(c) A licensee who needs to amend a notification may do so by telephoning the Division of Industrial and Medical Nuclear Safety at (301) 415-7197.
(a) Each licensee authorized to import natural uranium, other than in the form of ore or ore residue, in amounts exceeding 500 kilograms, from countries not party to the Convention on the Physical Protection of Nuclear Material (see appendix F of part 73 of this chapter) shall notify the Division of Industrial and Medical Nuclear Safety, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The notification must be in writing and must be received at least 10 days before transport of the shipment commences at the shipping facility.
(b) The notification must include the following information:
(1) The name(s), address(es), and telephone number(s) of the shipper, receiver, and carrier(s);
(2) A physical description of the shipment;
(3) A listing of the mode(s) of shipment, transfer points, and routes to be used;
(4) The estimated date and time that shipment will commence and that each nation along the route is scheduled to be entered.
(c) The licensee shall notify the Division of Industrial and Medical Nuclear Safety by telephone at (301) 415-7197 when the shipment is received at the receiving facility.
(d) A licensee who needs to amend a notification may do so by telephoning the Division of Industrial and Medical Nuclear Safety at (301) 415-7197.
(a) The terms and conditions of each license shall be subject to amendment, revision, or modification by reason of amendments to the Act, or by reason of rules, regulations, or orders issued in accordance with the Act.
(b) Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under section 182 of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Commission to refuse to grant a license on an original application, or for violation of, or failure to observe any of, the terms and conditions of the Act, or the license, or of any rule, regulation or order of the Commission.
(c) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded opportunity to demonstrate or achieve compliance with all lawful requirements.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 40 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in part 40 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 40.1, 40.2, 40.2a, 40.4, 40.5, 40.6, 40.8, 40.11, 40.12, 40.13, 40.14, 40.20, 40.21, 40.31, 40.32, 40.34, 40.43, 40.44, 40.45, 40.71, 40.81, and 40.82.
In many cases, flexibility is provided in the criteria to allow achieving an optimum tailings disposal program on a site-specific basis. However, in such cases the objectives, technical alternatives and concerns which must be taken into account in developing a tailings program are identified. As provided by the provisions of § 40.31(h) applications for licenses must clearly demonstrate how the criteria have been addressed.
The specifications must be developed considering the expected full capacity of tailings or waste systems and the lifetime of mill operations. Where later expansions of systems or operations may be likely (for example, where large quantities of ore now marginally uneconomical may be stockpiled), the amenability of the disposal system to accommodate increased capacities without degradation in long-term stability and other performance factors must be evaluated.
Licensees or applicants may propose alternatives to the specific requirements in this appendix. The alternative proposals may take into account local or regional conditions, including geology, topography, hydrology, and meterology. The Commission may find that the proposed alternatives meet the Commission's requirements if the alternatives will achieve a level of stabilization and containment of the sites concerned, and a level of protection for public health, safety, and the environment from radiological and nonradiological hazards associated with the sites, which is equivalent to, to the extent practicable, or more stringent than the level which would be achieved by the requirements of this appendix and the standards promulgated by the Environmental Protection Agency in 40 CFR part 192, subparts D and E.
All site specific licensing decisions based on the criteria in this appendix or alternatives proposed by licensees or applicants will take into account the risk to the public health and safety and the environment with due consideration to the economic costs involved and any other factors the Commission determines to be appropriate. In implementing this appendix, the Commission will consider “practicable” and “reasonably achievable” as equivalent terms. Decisions involved these terms will take into account the state of technology, and the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to the utilization of atomic energy in the public interest.
The following definitions apply to the specified terms as used in this appendix:
(1) Physical conditions at the site;
(2) Inclement weather or climatic conditions;
(3) An act of God;
(4) An act of war;
(5) A judicial or administrative order or decision, or change to the statutory, regulatory, or other legal requirements applicable to the licensee's facility that would preclude or delay the performance of activities required for compliance;
(6) Labor disturbances;
(7) Any modifications, cessation or delay ordered by State, Federal, or local agencies;
(8) Delays beyond the time reasonably required in obtaining necessary government permits, licenses, approvals, or consent for activities described in the reclamation plan proposed by the licensee that result from agency failure to take final action after the licensee has made a good faith, timely effort to submit legally sufficient applications, responses to requests (including relevant data requested by the agencies), or other information, including approval of the reclamation plan; and
(9) An act or omission of any third party over whom the licensee has no control.
Remoteness from populated areas;
Hydrologic and other natural conditions as they contribute to continued immobilization and isolation of contaminants from ground-water sources; and
Potential for minimizing erosion, disturbance, and dispersion by natural forces over the long term.
The site selection process must be an optimization to the maximum extent reasonably achievable in terms of these features.
In the selection of disposal sites, primary emphasis must be given to isolation of tailings or wastes, a matter having long-term impacts, as opposed to consideration only of short-term convenience or benefits, such as minimization of transportation or land acquisition costs. While isolation of tailings will be a function of both site and engineering design, overriding consideration must be given to siting features given the long-term nature of the tailings hazards.
Tailings should be disposed of in a manner that no active maintenance is required to preserve conditions of the site.
(a) Upstream rainfall catchment areas must be minimized to decrease erosion potential and the size of the floods which could erode or wash out sections of the tailings disposal area.
(b) Topographic features should provide good wind protection.
(c) Embankment and cover slopes must be relatively flat after final stabilization to minimize erosion potential and to provide conservative factors of safety assuring long-term stability. The broad objective should be to contour final slopes to grades which are as close as possible to those which would be provided if tailings were disposed of below grade; this could, for example, lead to slopes of about 10 horizontal to 1 vertical (10h:1v) or less steep. In general, slopes should not be steeper than about 5h:1v. Where steeper slopes are proposed, reasons why a slope less steep than 5h:1v would be impracticable should be provided, and compensating factors and conditions which make such slopes acceptable should be identified.
(d) A full self-sustaining vegetative cover must be established or rock cover employed to reduce wind and water erosion to negligible levels.
Where a full vegetative cover is not likely to be self-sustaining due to climatic or other conditions, such as in semi-arid and arid regions, rock cover must be employed on slopes of the impoundment system. The NRC will consider relaxing this requirement for extremely gentle slopes such as those which may exist on the top of the pile.
The following factors must be considered in establishing the final rock cover design to avoid displacement of rock particles by human and animal traffic or by natural process, and to preclude undercutting and piping:
Shape, size, composition, and gradation of rock particles (excepting bedding material average particles size must be at least cobble size or greater);
Rock cover thickness and zoning of particles by size; and
Steepness of underlying slopes.
Individual rock fragments must be dense, sound, and resistant to abrasion, and must be free from cracks, seams, and other defects that would tend to unduly increase their destruction by water and frost actions. Weak, friable, or laminated aggregate may not be used.
Rock covering of slopes may be unnecessary where top covers are very thick ( or less); bulk cover materials have inherently favorable erosion resistance characteristics; and, there is negligible drainage catchment area upstream of the pile and good wind protection as described in points (a) and (b) of this Criterion.
Furthermore, all impoundment surfaces must be contoured to avoid areas of concentrated surface runoff or abrupt or sharp changes in slope gradient. In addition to rock cover on slopes, areas toward which surface runoff might be directed must be well protected with substantial rock cover (rip rap). In addition to providing for stability of the impoundment system itself, overall stability, erosion potential, and geomorphology of surrounding terrain must be evaluated to assure that there are not ongoing or potential processes, such as gully erosion, which would lead to impoundment instability.
(e) The impoundment may not be located near a capable fault that could cause a maximum credible earthquake larger than that which the impoundment could reasonably be expected to withstand. As used in this criterion, the term “capable fault” has the same meaning as defined in section III(g) of appendix A of 10 CFR part 100. The term “maximum credible earthquake” means that
(f) The impoundment, where feasible, should be designed to incorporate features which will promote deposition. For example, design features which promote deposition of sediment suspended in any runoff which flows into the impoundment area might be utilized; the object of such a design feature would be to enhance the thickness of cover over time.
5A(1)—The primary ground-water protection standard is a design standard for surface impoundments used to manage uranium and thorium byproduct material. Unless exempted under paragraph 5A(3) of this criterion, surface impoundments (except for an existing portion) must have a liner that is designed, constructed, and installed to prevent any migration of wastes out of the impoundment to the adjacent subsurface soil, ground water, or surface water at any time during the active life (including the closure period) of the impoundment. The liner may be constructed of materials that may allow wastes to migrate into the liner (but not into the adjacent subsurface soil, ground water, or surface water) during the active life of the facility, provided that impoundment closure includes removal or decontamination of all waste residues, contaminated containment system components (liners, etc.), contaminated subsoils, and structures and equipment contaminated with waste and leachate. For impoundments that will be closed with the liner material left in place, the liner must be constructed of materials that can prevent wastes from migrating into the liner during the active life of the facility.
5A(2)—The liner required by paragraph 5A(1) above must be—
(a) Constructed of materials that have appropriate chemical properties and sufficient strength and thickness to prevent failure due to pressure gradients (including static head and external hydrogeologic forces), physical contact with the waste or leachate to which they are exposed, climatic conditions, the stress of installation, and the stress of daily operation;
(b) Placed upon a foundation or base capable of providing support to the liner and resistance to pressure gradients above and below the liner to prevent failure of the liner due to settlement, compression, or uplift; and
(c) Installed to cover all surrounding earth likely to be in contact with the wastes or leachate.
5A(3)—The applicant or licensee will be exempted from the requirements of paragraph 5A(1) of this criterion if the Commission finds, based on a demonstration by the applicant or licensee, that alternate design and operating practices, including the closure plan, together with site characteristics will prevent the migration of any hazardous constituents into ground water or surface water at any future time. In deciding whether to grant an exemption, the Commission will consider—
(a) The nature and quantity of the wastes;
(b) The proposed alternate design and operation;
(c) The hydrogeologic setting of the facility, including the attenuative capacity and thickness of the liners and soils present between the impoundment and ground water or surface water; and
(d) All other factors which would influence the quality and mobility of the leachate produced and the potential for it to migrate to ground water or surface water.
5A(4)—A surface impoundment must be designed, constructed, maintained, and operated to prevent overtopping resulting from normal or abnormal operations, overfilling, wind and wave actions, rainfall, or run-on; from malfunctions of level controllers, alarms, and other equipment; and from human error.
5A(5)—When dikes are used to form the surface impoundment, the dikes must be designed, constructed, and maintained with sufficient structural integrity to prevent massive failure of the dikes. In ensuring structural integrity, it must not be presumed that the liner system will function without leakage during the active life of the impoundment.
5B(1)—Uranium and thorium byproduct materials must be managed to conform to the following secondary ground-water protection standard: Hazardous constituents entering the ground water from a licensed site must not exceed the specified concentration limits in the uppermost aquifer beyond the point of compliance during the compliance period. Hazardous constituents are those constituents identified by the Commission pursuant to paragraph 5B(2) of this criterion. Specified concentration limits are those limits established by the Commission as indicated in paragraph 5B(5) of this criterion. The Commission will also establish the point of compliance and compliance period on a site specific basis through license conditions and orders. The objective in selecting the point of compliance is to provide the earliest practicable warning that the impoundment is releasing hazardous constituents to the
5B(2)—A constituent becomes a hazardous constituent subject to paragraph 5B(5) only when the constituent meets all three of the following tests:
(a) The constituent is reasonably expected to be in or derived from the byproduct material in the disposal area;
(b) The constituent has been detected in the ground water in the uppermost aquifer; and
(c) The constituent is listed in Criterion 13 of this appendix.
5B(3)—Even when constituents meet all three tests in paragraph 5B(2) of this criterion, the Commission may exclude a detected constituent from the set of hazardous constituents on a site specific basis if it finds that the constituent is not capable of posing a substantial present or potential hazard to human health or the environment. In deciding whether to exclude constituents, the Commission will consider the following:
(a) Potential adverse effects on ground-water quality, considering—
(i) The physical and chemical characteristics of the waste in the licensed site, including its potential for migration;
(ii) The hydrogeological characteristics of the facility and surrounding land;
(iii) The quantity of ground water and the direction of ground-water flow;
(iv) The proximity and withdrawal rates of ground-water users;
(v) The current and future uses of ground water in the area;
(vi) The existing quality of ground water, including other sources of contamination and their cumulative impact on the ground-water quality;
(vii) The potential for health risks caused by human exposure to waste constituents;
(viii) The potential damage to wildlife, crops, vegetation, and physical structures caused by exposure to waste constituents;
(ix) The persistence and permanence of the potential adverse effects.
(b) Potential adverse effects on hydraulically-connected surface water quality, considering—
(i) The volume and physical and chemical characteristics of the waste in the licensed site;
(ii) The hydrogeological characteristics of the facility and surrounding land;
(iii) The quantity and quality of ground water, and the direction of ground-water flow;
(iv) The patterns of rainfall in the region;
(v) The proximity of the licensed site to surface waters;
(vi) The current and future uses of surface waters in the area and any water quality standards established for those surface waters;
(vii) The existing quality of surface water, including other sources of contamination and the cumulative impact on surface-water quality;
(viii) The potential for health risks caused by human exposure to waste constituents;
(ix) The potential damage to wildlife, crops, vegetation, and physical structures caused by exposure to waste constituents; and
(x) The persistence and permanence of the potential adverse effects.
5B(4)—In making any determinations under paragraphs 5B(3) and 5B(6) of this criterion about the use of ground water in the area around the facility, the Commission will consider any identification of underground sources of drinking water and exempted aquifers made by the Environmental Protection Agency.
5B(5)—At the point of compliance, the concentration of a hazardous constituent must not exceed—
(a) The Commission approved background concentration of that constituent in the ground water;
(b) The respective value given in the table in paragraph 5C if the constituent is listed in the table and if the background level of the constituent is below the value listed; or
(c) An alternate concentration limit established by the Commission.
5B(6)—Conceptually, background concentrations pose no incremental hazards and the drinking water limits in paragraph 5C state acceptable hazards but these two options may not be practically achievable at a specific site. Alternate concentration limits that present no significant hazard may be proposed by licensees for Commission consideration. Licensees must provide the basis for any proposed limits including consideration of practicable corrective actions, that limits are as low as reasonably achievable, and information on the factors the Commission must consider. The Commission will establish a site specific alternate concentration limit for a hazardous constituent as provided in paragraph 5B(5) of this criterion if it finds that the proposed limit is as low as reasonably achievable, after considering practicable corrective actions, and that the constituent will not pose a substantial present or potential hazard to human health or the
(a) Potential adverse effects on ground-water quality, considering—
(i) The physical and chemical characteristics of the waste in the licensed site including its potential for migration;
(ii) The hydrogeological characteristics of the facility and surrounding land;
(iii) The quantity of ground water and the direction of ground-water flow;
(iv) The proximity and withdrawal rates of ground-water users;
(v) The current and future uses of ground water in the area;
(vi) The existing quality of ground water, including other sources of contamination and their cumulative impact on the ground-water quality;
(vii) The potential for health risks caused by human exposure to waste constituents;
(viii) The potential damage to wildlife, crops, vegetation, and physical structures caused by exposure to waste constituents;
(ix) The persistence and permanence of the potential adverse effects.
(b) Potential adverse effects on hydraulically-connected surface water quality, considering—
(i) The volume and physical and chemical characteristics of the waste in the licensed site;
(ii) The hydrogeological characteristics of the facility and surrounding land;
(iii) The quantity and quality of ground water, and the direction of ground-water flow;
(iv) The patterns of rainfall in the region;
(v) The proximity of the licensed site to surface waters;
(vi) The current and future uses of surface waters in the area and any water quality standards established for those surface waters;
(vii) The existing quality of surface water including other sources of contamination and the cumulative impact on surface water quality;
(viii) The potential for health risks caused by human exposure to waste constituents;
(ix) The potential damage to wildlife, crops, vegetation, and physical structures caused by exposure to waste constituents; and
(x) The persistence and permanence of the potential adverse effects.
5D—If the ground-water protection standards established under paragraph 5B(1) of this criterion are exceeded at a licensed site, a corrective action program must be put into operation as soon as is practicable, and in no event later than eighteen (18) months after the Commission finds that the standards have been exceeded. The licensee shall submit the proposed corrective action program and supporting rationale for Commission approval prior to putting the program into operation, unless otherwise directed by the Commission. The objective of the program is to return hazardous constituent concentration levels in ground water to the concentration limits set as standards. The licensee's proposed program must address removing the hazardous constituents that have entered the ground water at the point of compliance or treating them in place. The program must also address removing or treating in place any hazardous constituents that exceed concentration limits in ground water between the point of compliance and the downgradient facility property boundary. The licensee shall continue corrective action measures to the extent necessary to achieve and maintain compliance with the ground-water protection standard. The Commission will determine when the licensee may terminate corrective action measures based on
5E—In developing and conducting ground-water protection programs, applicants and licensees shall also consider the following:
(1) Installation of bottom liners (Where synthetic liners are used, a leakage detection system must be installed immediately below the liner to ensure major failures are detected if they occur. This is in addition to the ground-water monitoring program conducted as provided in Criterion 7. Where clay liners are proposed or relatively thin, in-situ clay soils are to be relied upon for seepage control, tests must be conducted with representative tailings solutions and clay materials to confirm that no significant deterioration of permeability or stability properties will occur with continuous exposure of clay to tailings solutions. Tests must be run for a sufficient period of time to reveal any effects if they are going to occur (in some cases deterioration has been observed to occur rather rapidly after about nine months of exposure)).
(2) Mill process designs which provide the maximum practicable recycle of solutions and conservation of water to reduce the net input of liquid to the tailings impoundment.
(3) Dewatering of tailings by process devices and/or in-situ drainage systems (At new sites, tailings must be dewatered by a drainage system installed at the bottom of the impoundment to lower the phreatic surface and reduce the driving head of seepage, unless tests show tailings are not amenable to such a system. Where in-situ dewatering is to be conducted, the impoundment bottom must be graded to assure that the drains are at a low point. The drains must be protected by suitable filter materials to assure that drains remain free running. The drainage system must also be adequately sized to assure good drainage).
(4) Neutralization to promote immobilization of hazardous constituents.
5F—Where ground-water impacts are occurring at an existing site due to seepage, action must be taken to alleviate conditions that lead to excessive seepage impacts and restore ground-water quality. The specific seepage control and ground-water protection method, or combination of methods, to be used must be worked out on a site-specific basis. Technical specifications must be prepared to control installation of seepage control systems. A quality assurance, testing, and inspection program, which includes supervision by a qualified engineer or scientist, must be established to assure the specifications are met.
5G—In support of a tailings disposal system proposal, the applicant/operator shall supply information concerning the following:
(1) The chemical and radioactive characteristics of the waste solutions.
(2) The characteristics of the underlying soil and geologic formations particularly as they will control transport of contaminants and solutions. This includes detailed information concerning extent, thickness, uniformity, shape, and orientation of underlying strata. Hydraulic gradients and conductivities of the various formations must be determined. This information must be gathered from borings and field survey methods taken within the proposed impoundment area and in surrounding areas where contaminants might migrate to ground water. The information gathered on boreholes must include both geologic and geophysical logs in sufficient number and degree of sophistication to allow determining significant discontinuities, fractures, and channeled deposits of high hydraulic conductivity. If field survey methods are used, they should be in addition to and calibrated with borehole logging. Hydrologic parameters such as permeability may not be determined on the basis of laboratory analysis of samples alone; a sufficient amount of field testing (e.g., pump tests) must be conducted to assure actual field properties are adequately understood. Testing must be conducted to allow estimating chemi-sorption attenuation properties of underlying soil and rock.
(3) Location, extent, quality, capacity and current uses of any ground water at and near the site.
5H—Steps must be taken during stockpiling of ore to minimize penetration of radionuclides into underlying soils; suitable methods include lining and/or compaction of ore storage areas.
(2) As soon as reasonably achievable after emplacement of the final cover to limit releases of radon-222 from uranium byproduct material and prior to placement of erosion protection barriers or other features necessary for long-term control of the tailings, the licensee shall verify through appropriate testing and analysis that the design and construction of the final radon barrier is effective in limiting releases of radon-222 to a level not exceeding 20 pCi/m
(3) When phased emplacement of the final radon barrier is included in the applicable reclamation plan, the verification of radon-222 release rates required in paragraph (2) of this criterion must be conducted for each portion of the pile or impoundment as the final radon barrier for that portion is emplaced.
(4) Within ninety days of the completion of all testing and analysis relevant to the required verification in paragraphs (2) and (3) of this criterion, the uranium mill licensee shall report to the Commission the results detailing the actions taken to verify that levels of release of radon-222 do not exceed 20 pCi/m
(5) Near surface cover materials (i.e., within the top three meters) may not include waste or rock that contains elevated levels of radium; soils used for near surface covermust be essentially the same, as far as radioactivity is concerned, as that of surrounding surface soils. This is to ensure that surface radon exhalation is not significantly above background because of the cover material itself.
(6) The design requirements in this criterion for longevity and control of radon releases apply to any portion of a licensed and/or disposal site unless such portion contains a concentration of radium in land, averaged over areas of 100 square meters, which, as a result of byproduct material, does not exceed the background level by more than: (i) 5 picocuries per gram (pCi/g) of radium-226, or, in the case of thorium byproduct material, radium-228, averaged over the first 15 centimeters (cm) below the surface, and (ii) 15 pCi/g of radium-226, or, in the case of thorium byproduct material, radium-228, averaged over 15-cm thick layers more than 15 cm below the surface.
Byproduct material containing concentrations of radionuclides other than radium in soil, and surface activity on remaining structures, must not result in a total effective dose equivalent (TEDE) exceeding the dose from cleanup of radium contaminated soil to the above standard (benchmark dose), and must be at levels which are as low as is reasonably achievable. If more than one residual radionuclide is present in the same 100-square-meter area, the sum of the ratios for each radionuclide of concentration present to the concentration limit will not exceed “1” (unity). A calculation of the potential peak annual TEDE within 1000 years to the average member of the critical group that would result from applying the radium standard (not including radon) on the site must be submitted for approval. The use of decommissioning plans with benchmark doses which exceed 100 mrem/yr, before application of ALARA, requires the approval of the Commission after consideration of the recommendation of the NRC staff. This requirement for dose criteria does not apply to sites that have decommissioning plans for soil and structures approved before June 11, 1999.
(7) The licensee shall also address the nonradiological hazards associated with the wastes in planning and implementing closure. The licensee shall ensure that disposal areas are closed in a manner that minimizes the need for further maintenance. To the extent necessary to prevent threats to human health and the environment, the licensee shall control, minimize, or eliminate post-closure escape of nonradiological hazardous
(2) The Commission may approve a licensee's request to extend the time for performance of milestones related to emplacement of the final radon barrier if, after providing an opportunity for public participation, the Commission finds that the licensee has adequately demonstrated in the manner required in paragraph (2) of Criterion 6 that releases of radon-222 do not exceed an average of 20 pCi/m
(3) The Commission may authorize by license amendment, upon licensee request, a portion of the impoundment to accept uranium byproduct material or such materials that are similar in physical, chemical, and radiological characteristics to the uranium mill tailings and associated wastes already in the pile or impoundment, from other sources, during the closure process. No such authorization will be made if it results in a delay or impediment to emplacement of the final radon barrier over the remainder of the impoundment in a manner that will achieve levels of radon-222 releases not exceeding 20 pCi/m
7A—The licensee shall establish a detection monitoring program needed for the Commission to set the site-specific ground-water protection standards in paragraph 5B(1) of this appendix. For all monitoring under this paragraph the licensee or applicant will propose for Commission approval as license conditions which constituents are to be monitored on a site specific basis. A detection monitoring program has two purposes.The initial purpose of the program is to detect leakage of hazardous constituents from the disposal area so that the need to set ground-water protection standards is monitored. If leakage is detected, the second purpose of the program is to generate data and information needed for the Commission to establish the standards under Criterion 5B. The data and information must provide a sufficient basis to identify those hazardous constituents which require concentration limit standards and to enable the Commission to set the limits for those constituents and the compliance period. They may also need to provide the basis for adjustments to the point of compliance. For licenses in effect September 30, 1983, the detection monitoring programs must have been in place by
Checks must be made and logged hourly of all parameters (e.g., differential pressures and scrubber water flow rates) that determine the efficiency of yellowcake stack emission control equipment operation. The licensee shall retain each log as a record for three years after the last entry in the log is made. It must be determined whether or not conditions are within a range prescribed to ensure that the equipment is operating consistently near peak efficiency; corrective action must be taken when performance is outside of prescribed ranges. Effluent control devices must be operative at all times during drying and packaging operations and whenever air is exhausting from the yellowcake stack. Drying and packaging operations must terminate when controls are inoperative. When checks indicate the equipment is not operating within the range prescribed for peak efficiency, actions must be taken to restore parameters to the prescribed range. When this cannot be done without shutdown and repairs, drying and packaging operations must cease as soon as practicable. Operations may not be restarted after cessation due to off-normal performance until needed corrective actions have been identified and implemented. All these cessations, corrective actions, and restarts must be reported to the appropriate NRC regional office as indicated in Criterion 8A, in writing, within ten days of the subsequent restart.
To control dusting from tailings, that portion not covered by standing liquids must be wetted or chemically stabilized to prevent or minimize blowing and dusting to the maximum extent reasonably achievable. This requirement may be relaxed if tailings are effectively sheltered from wind, such as may be the case where they are disposed of below grade and the tailings surface is not exposed to wind. Consideration must be given in planning tailings disposal programs to methods which would allow phased covering and reclamation of tailings impoundments because this will help in controlling particulate and radon emissions during operation. To control dusting from diffuse sources, such as tailings and ore pads where automatic controls do not apply, operators shall develop written operating procedures specifying the methods of control which will be utilized.
Milling operations producing or involving thorium byproduct material must be conducted in such a manner as to provide reasonable assurance that the annual dose equivalent does not exceed 25 millirems to the whole body, 75 millirems to the thyroid, and 25 millirems to any other organ of any member of the public as a result of exposures to the planned discharge of radioactive materials, radon-220 and its daughters excepted, to the general environment.
Uranium and thorium byproduct materials must be managed so as to conform to the applicable provisions of title 40 of the Code of Federal Regulations, part 440, “Ore Mining and Dressing Point Source Category: Effluent Limitations Guidelines and New Source Performance Standards, subpart C, Uranium, Radium, and Vanadium Ores Subcategory,” as codified on January 1, 1983.
This will yield a surety that is at least sufficient at all times to cover the costs of decommissioning and reclamation of the areas that are expected to be disturbed before the next license renewal. The term of the surety mechanism must be open ended, unless it can be demonstrated that another arrangement would provide an equivalent level of assurance. This assurance would be provided with a surety instrument which is written for a specified period of time (e.g., 5 years) yet which must be automatically renewed unless the surety notifies the beneficiary (the Commission or the State regulatory agency) and the principal (the licensee) some reasonable time (e.g., 90 days) prior to the renewal date of their intention not to renew. In such a situation the surety requirement still exists and the licensee would be required to submit an acceptable replacement surety within a brief period of time to allow at least 60 days for the regulatory agency to collect.
Proof of forfeiture must not be necessary to collect the surety so that in the event that the licensee could not provide an acceptable replacement surety within the required time, the surety shall be automatically collected prior to its expiration. The conditions described above would have to be clearly stated on any surety instrument which is not open-ended, and must be agreed to by all parties. Financial surety arrangements generally acceptable to the Commission are:
(a) Surety bonds;
(b) Cash deposits;
(c) Certificates of deposits;
(d) Deposits of government securities;
(e) Irrevocable letters or lines of credit; and
(f) Combinations of the above or such other types of arrangements as may be approved by the Commission. However, self insurance, or any arrangement which essentially constitutes self insurance (e.g., a contract with a State or Federal agency), will not satisfy the surety requirement since this provides no additional assurance other than that which already exists through license requirements.
If site surveillance or control requirements at a particular site are determined, on the basis of a site-specific evaluation, to be significantly greater than those specified in Criterion 12 (e.g., if fencing is determined to be necessary), variance in funding requirements may be specified by the Commission. In any case, the total charge to cover the costs of long-term surveillance must be such that, with an assumed 1 percent annual real interest rate, the collected funds will yield interest in an amount sufficient to cover the annual costs of site surveillance. The total charge will be adjusted annually prior to actual payment to recognize inflation. The inflation rate to be used is that indicated by the change in the Consumer Price Index published by the U.S. Department of Labor, Bureau of Labor Statistics.
B. Any uranium or thorium milling license or tailings license must contain such terms and conditions as the Commission determines necessary to assure that prior to termination of the license, the licensee will comply with ownership requirements of this criterion for sites used for tailings disposal.
C. Title to the byproduct material licensed under this part and land, including any interests therein (other than land owned by the United States or by a State) which is used for the disposal of any such byproduct material, or is essential to ensure the long term stability of such disposal site, must be transferred to the United States or the State in which such land is located, at the option of such State. In view of the fact that physical isolation must be the primary means of long-term control, and Government land ownership is a desirable supplementary measure, ownership of certain severable subsurface interests (for example, mineral rights) may be determined to be unnecessary to protect the public health and safety and the environment. In any case, however, the applicant/operator must demonstrate a serious effort to obtain such subsurface rights, and must, in the event that certain rights cannot be obtained, provide notification in local public land records of the fact that the land is being used for the disposal of radioactive material and is subject to either an NRC general or specific license prohibiting the disruption and disturbance of the tailings. In some rare cases, such as may occur with deep burial where no ongoing site surveillance will be required, surface land ownership transfer requirements may be waived. For licenses issued before November 8, 1981, the Commission may take into account the status of the ownership of such land, and interests therein, and the ability of a licensee to transfer title and custody thereof to the United States or a State.
D. If the Commission subsequent to title transfer determines that use of the surface or subsurface estates, or both, of the land transferred to the United States or to a State will not endanger the public health, safety, welfare, or environment, the Commission may permit the use of the surface or subsurface estates, or both, of such land in a manner consistent with the provisions provided in these criteria. If the Commission permits such use of such land, it will provide the person who transferred such land with the right of first refusal with respect to such use of such land.
E. Material and land transferred to the United States or a State in accordance with this Criterion must be transferred without cost to the United States or a State other than administrative and legal costs incurred in carrying out such transfer.
F. The provisions of this part respecting transfer of title and custody to land and tailings and wastes do not apply in the case of lands held in trust by the United States for any Indian tribe or lands owned by such Indian tribe subject to a restriction against alienation imposed by the United States. In the case of such lands which are used for the disposal of byproduct material, as defined in this part, the licensee shall enter into arrangements with the Commission as may be appropriate to assure the long-term surveillance of such lands by the United States.
Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936, 937, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2236, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5841). Section 50.10 also issued under secs. 101, 185, 68 Stat. 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd), and 50.103 also
The regulations in this part are promulgated by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended (68 Stat. 919), and Title II of the Energy Reorganization Act of 1974 (88 Stat. 1242), to provide for the licensing of production and utilization facilities. This part also gives notice to all persons who knowingly provide to any licensee, applicant, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's or applicant's activities subject to this part, that they may be individually subject to NRC enforcement action for violation of § 50.5.
As used in this part,
(1) Is connectable to but not normally connected to the offsite or onsite emergency ac power systems;
(2) Has minimum potential for common mode failure with offsite power or the onsite emergency ac power sources;
(3) Is available in a timely manner after the onset of station blackout; and
(4) Has sufficient capacity and reliability for operation of all systems required for coping with station blackout and for the time required to bring and maintain the plant in safe shutdown (non-design basis accident).
(1) When applied to nuclear power reactors, any plant structure, system, component, or part thereof necessary to assure
(i) The integrity of the reactor coolant pressure boundary,
(ii) The capability to shut down the reactor and maintain it in a safe shutdown condition, or
(iii) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to those referred to in § 50.34(a)(1), § 50.67(b)(2), or § 100.11 of this chapter, as applicable.
(2) When applied to other types of facilities or portions of such facilities for which construction permits are issued under § 50.23, a component, structure, system or part thereof that is directly procured by the construction permit holder for the facility subject to the regulations of this part and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the Commission could create a substantial safety hazard.
(3) In all cases,
(1) Release of the property for unrestricted use and termination of the license; or
(2) Release of the property under restricted conditions and termination of the license.
(1) A deviation in a basic component delivered to a purchaser for use in a facility or activity subject to a construction permit under this part, if on the basis of an evaluation, the deviation could create a substantial safety hazard; or
(2) The installation, use, or operation of a basic component containing, a defect as defined in paragraph (1) of this definition; or
(3) A deviation in a portion of a facility subject to the construction permit of this part provided the deviation could, on the basis of an evaluation, create a substantial safety hazard.
(1) Any nuclear reactor designed or used primarily for the formation of plutonium or uranium-233; or
(2) Any facility designed or used for the separation of the isotopes of plutonium, except laboratory scale facilities designed or used for experimental or analytical purposes only; or
(3) Any facility designed or used for the processing of irradiated materials containing special nuclear material, except (i) laboratory scale facilities designed or used for experimental or analytical purposes, (ii) facilities in which the only special nuclear materials contained in the irradiated material to be processed are uranium enriched in the isotope U-235 and plutonium produced by the irradiation, if the material processed contains not more than 10
(1) Part of the reactor coolant system, or
(2) Connected to the reactor coolant system, up to and including any and all of the following:
(i) The outermost containment isolation valve in system piping which penetrates primary reactor containment,
(ii) The second of two valves normally closed during normal reactor operation in system piping which does not penetrate primary reactor containment,
(iii) The reactor coolant system safety and relief valves.
(1) The integrity of the reactor coolant pressure boundary
(2) The capability to shut down the reactor and maintain it in a safe shutdown condition; or
(3) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to the applicable guideline exposures set forth in § 50.34(a)(1) or § 100.11 of this chapter, as applicable.
(1) A thermal power level in excess of 10 megawatts; or
(2) A thermal power level in excess of 1 megawatt, if the reactor is to contain:
(i) A circulating loop through the core in which the applicant proposes to conduct fuel experiments; or
(ii) A liquid fuel loading; or
(iii) An experimental facility in the core in excess of 16 square inches in cross-section.
Pursuant to subsections 11v. and 11cc., respectively, of the Act, the Commission may from time to time add to, or otherwise alter, the foregoing definitions of production and utilization facility. It may also include as a facility an important component part especially designed for a facility, but has not at this time included any component parts in the definitions.
For
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.
(a)
(b)
(1)
(2)
(i) Applications for licenses for facilities described in § 50.21 (a) and (c) and amendments to these applications: The signed original must be sent to the Nuclear Regulatory Commission. Document Control Desk, Washington, DC 20555 and one copy to the appropriate Regional Office.
(ii) Applications for permits and licenses for facilities described in § 50.21(b) or § 50.22, and amendments to these applications: the signed original and 37 copies must be sent to the Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555, one copy to the appropriate Regional Office, and one copy to the appropriate NRC Resident Inspector, if one has been assigned to the site of the facility.
(3)
(4)
(i) Physical security plan pursuant to § 50.34;
(ii) Safeguards contingency plan pursuant to § 50.34;
(iii) Change to security plan, guard training and qualification plan, or safeguards contingency plan made without prior Commission approval pursuant to § 50.54(p);
(iv) Application for amendment of physical security plan, guard training and qualification plan, or safeguards contingency plan pursuant to § 50.90.
(5)
(i) Emergency plan pursuant to § 50.34;
(ii) Change to an emergency plan pursuant to § 50.54(q);
(iii) Emergency implementing procedures pursuant to appendix E.V of this part.
(6)
(7)
(ii) A change to an NRC-accepted quality assurance topical report from nonlicensees (i.e., architect/engineers, NSSS suppliers, fuel suppliers, constructors, etc.) must be submitted as follows: one signed original to the Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555.
(8)
(9)
(c)
(d)
(e)
(f)
(a) Any licensee, applicant for a license, employee of a licensee or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or applicant for a license, who knowingly provides to any licensee, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's or applicant's activities in this part, may not:
(1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or
(2) Deliberately submit to the NRC, a licensee, an applicant, or a licensee's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the NRC.
(b) A person who violates paragraph (a)(1) or (a)(2) of this section may be subject to enforcement action in accordance with the procedures in 10 CFR part 2, subpart B.
(c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:
(1) Would cause a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or
(2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, applicant, contractor, or subcontractor.
(a) Discrimination by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act.
(1) The protected activities include but are not limited to:
(i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of this section or possible violations of requirements imposed under either of those statutes;
(ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer;
(iii) Requesting the Commission to institute action against his or her employer for the administration or enforcement of these requirements;
(iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text.
(v) Assisting or participating in, or is about to assist or participate in, these activities.
(2) These activities are protected even if no formal proceeding is actually initiated as a result of the employee assistance or participation.
(3) This section has no application to any employee alleging discrimination prohibited by this section who, acting without direction from his or her employer (or the employer's agent), deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as amended, or the Atomic Energy Act of 1954, as amended.
(b) Any employee who believes that he or she has been discharged or otherwise discriminated against by any person for engaging in protected activities specified in paragraph (a)(1) of this section may seek a remedy for the discharge or discrimination through an administrative proceeding in the Department of Labor. The administrative proceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Employment Standards Administration, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.
(c) A violation of paragraph (a), (e), or (f) of this section by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant may be grounds for—
(1) Denial, revocation, or suspension of the license.
(2) Imposition of a civil penalty on the licensee or applicant.
(3) Other enforcement action.
(d) Actions taken by an employer, or others, which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee's engagement in protected activities does not automatically render him or her immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.
(e)(1) Each licensee and each applicant for a license shall prominently post the revision of NRC Form 3, “Notice to Employees,” referenced in 10 CFR 19.11(c). This form must be posted at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted not later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days following license termination.
(2) Copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D to part 20 of this chapter or by calling the NRC Information and Records Management Branch at (301) 415-7230.
(f) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department of Labor pursuant to section 211 of the Energy Reorganization Act of 1974, as amended, may contain any provision which would prohibit, restrict, or otherwise discourage an employee from participating in protected activity as defined in paragraph (a)(1) of this section including, but not limited to, providing information to the NRC or to his or her employer on potential violations or other matters within NRC's regulatory responsibilities.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management
(b) The approved information collection requirements contained in this part appear in §§ 50.30, 50.33, 50.33a, 50.34, 50.34a, 50.35, 50.36, 50.36a, 50.36b, 50.44, 50.46, 50.47, 50.48, 50.49, 50.54, 50.55, 50.55a, 50.59, 50.60, 50.61, 50.62, 50.63, 50.64, 50.65, 50.66, 50.68, 50.71, 50.72, 50.74, 50.75, 50.80, 50.82, 50.90, 50.91, 50.120, and appendices A, B, E, G, H, I, J, K, M, N, O, Q, R, and S to this part.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1) In § 50.73, NRC Form 366 is approved under control number 3150-0104.
(2) In § 50.78, Form N-71 is approved under control number 3150-0056.
(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.
(b) Each applicant or licensee shall notify the Commission of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or updating requirements.
(a) Except as provided in § 50.11, no person within the United States shall transfer or receive in interstate commerce, manufacture, produce, transfer, acquire, possess, or use any production or utilization facility except as authorized by a license issued by the Commission.
(b) No person shall begin the construction of a production or utilization facility on a site on which the facility is to be operated until a construction permit has been issued. As used in this paragraph, the term “construction” shall be deemed to include pouring the foundation for, or the installation of, any portion of the permanent facility on the site, but does not include:
(1) Site exploration, site excavation, preparation of the site for construction of the facility, including the driving of piles, and construction of roadways, railroad spurs, and transmission lines;
(2) Procurement or manufacture of components of the facility;
(3) Construction of non-nuclear facilities (such as turbogenerators and turbine buildings) and temporary buildings (such as construction equipment storage sheds) for use in connection with the construction of the facility; and
(4) With respect to production or utilization facilities, other than testing facilities, required to be licensed pursuant to section 104a or section 104c of the Act, the construction of buildings which will be used for activities other than operation of a facility and which may also be used to house a facility. (For example, the construction of a college laboratory building with space for installation of a training reactor is
(c) Notwithstanding the provisions of paragraph (b) of this section, and subject to paragraphs (d) and (e) of this section, no person shall effect commencement of construction of a production or utilization facility subject to the provisions of § 51.20(b) of this chapter on a site on which the facility is to be operated until a construction permit has been issued. As used in this paragraph, the term “commencement of construction” means any clearing of land, excavation or other substantial action that would adversely affect the environment of a site, but does not mean:
(1) Changes desirable for the temporary use of the land for public recreational uses, necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site or to the protection of environmental values;
(2) Procurement or manufacture of components of the facility; and
(3) With respect to production or utilization facilities, other than testing facilities, required to be licensed pursuant to section 104a or section 104c of the Act, the construction of buildings which will be used for activities other than operation of a facility and which may also be used to house a facility. (For example, the construction of a college laboratory building with space for installation of a training reactor is not affected by this paragraph.)
(d)(1) Each person subject to the provisions of paragraph (c) of this section, who is, on March 21, 1972, conducting activities permitted pursuant to paragraph (b) of this section in effect prior to March 21, 1972, may furnish to the Commission within 30 days after March 21, 1972 or such later date as may be approved by the Commission upon good cause shown, a written statement of any reasons, with supporting factual submission, why, with reference to the factors stated in paragraph (d)(2) of this section, the activities should be continued, pending the issuance of a construction permit, notwithstanding the provisions of paragraph (c) of this section. If such written statement has been submitted, within the time specified, such activities may continue to be conducted pending Commission action pursuant to paragraph (d)(2) of this section.
(2) Upon submission of a statement of reasons pursuant to paragraph (d)(1) of this section the Commission may authorize the continued conduct of activities permitted by paragraph (b) of this section in effect prior to March 21, 1972, upon consideration and balancing of the following factors:
(i) Whether continuation of the activities will give rise to a significant adverse impact on the environment and the nature and extent of such impact, if any;
(ii) Whether redress of any adverse environmental impact from continuation of the activities can reasonably be effected should such redress be necessary;
(iii) Whether continuation of the activities would foreclose subsequent adoption of alternatives; and
(iv) The effect of delay in conducting such activities on the public interest, including the power needs to be served by the proposed facility, the availability of alternative sources, if any, to meet those needs on a timely basis, and delay costs to the applicant and to consumers.
(3) Activities permitted to be continued pursuant to this paragraph (d) shall be conducted in such a manner as will minimize or reduce their environmental impact.
(e)(1) The Director of Nuclear Reactor Regulation may authorize an applicant for a construction permit for a utilization facility which is subject to § 51.20(b) of this chapter, and is of the type specified in § 50.21(b) (2) or (3) or § 50.22 or is a testing facility to conduct the following activities: (i) Preparation of the site for construction of the facility (including such activities as clearing, grading, construction of temporary access roads and borrow areas); (ii) installation of temporary construction support facilities (including such items as warehouse and shop facilities,
(2) Such an authorization shall be granted only after the presiding officer in the proceeding on the construction permit application (i) has made all the findings required by §§ 51.104(b) and 51.105 of this chapter to be made prior to issuance of the construction permit for the facility, and (ii) has determined that, based upon the available information and review to date, there is reasonable assurance that the proposed site is a suitable location for a reactor of the general size and type proposed from the standpoint of radiological health and safety considerations under the Act and rules and regulations promulgated by the Commission pursuant thereto.
(3)(i) The Director of Nuclear Reactor Regulation may authorize an applicant for a construction permit for a utilization facility which is subject to § 51.20(b) of this chapter, and is of the type specified in § 50.21(b) (2) or (3) or § 50.22 or is a testing facility to conduct, in addition to the activities described in paragraph (e)(1) of this section, the installation of structural foundations, including any necessary subsurface preparation, for structures, systems and components which prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public.
(ii) Such an authorization, which may be combined with the authorization described in paragraph (e)(1) of this section, or may be granted at a later time, shall be granted only after the presiding officer in the proceeding on the construction permit application has, in addition to making the findings and determinations required by paragraph (e)(2) of this section, determined that there are no unresolved safety issues relating to the additional activities that may be authorized pursuant to this paragraph that would constitute good cause for withholding authorization.
(4) Any activities undertaken pursuant to an authorization granted under this paragraph shall be entirely at the risk of the applicant and, except as to matters determined under paragraphs (e)(2) and (e)(3)(ii), the grant of the authorization shall have no bearing on the issuance of a construction permit with respect to the requirements of the Act, and rules, regulations, or orders promulgated pursuant thereto.
Nothing in this part shall be deemed to require a license for:
(a) The manufacture, production, or acquisition by the Department of Defense of any utilization facility authorized pursuant to section 91 of the Act, or the use of such facility by the Department of Defense or by a person under contract with and for the account of the Department of Defense;
(b) Except to the extent that Administration facilities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 are involved;
(1)(i) The processing, fabrication or refining of special nuclear material or the separation of special nuclear material, or the separation of special nuclear material from other substances by a prime contractor of the Department under a prime contract for:
(A) The performance of work for the Department at a United States government-owned or controlled site;
(B) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or
(C) The use or operation of a production or utilization facility in a United States owned vehicle or vessel; or
(ii) By a prime contractor or subcontractor of the Commission or the Department under a prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety;
(2)(i) The construction or operation of a production or utilization facility for the Department at a United States government-owned or controlled site, including the transportation of the production or utilization facility to or from such site and the performance of contract services during temporary interruptions of such transportation; or the construction or operation of a production or utilization facility for the Department in the performance of research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof; or the use or operation of a production or utilization facility for the Department in a United States government-owned vehicle or vessel:
(ii) The construction or operation of a production or utilization facility by a prime contractor or subcontractor of the Commission or the Department under his prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
(c) The transportation or possession of any production or utilization facility by a common or contract carrier or warehousemen in the regular course of carriage for another or storage incident thereto.
(a) The Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of the regulations of this part, which are—
(1) Authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security.
(2) The Commission will not consider granting an exemption unless special circumstances are present. Special circumstances are present whenever—
(i) Application of the regulation in the particular circumstances conflicts with other rules or requirements of the Commission; or
(ii) Application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule; or
(iii) Compliance would result in undue hardship or other costs that are significantly in excess of those contemplated when the regulation was adopted, or that are significantly in excess of those incurred by others similarly situated; or
(iv) The exemption would result in benefit to the public health and safety that compensates for any decrease in safety that may result from the grant of the exemption; or
(v) The exemption would provide only temporary relief from the applicable regulation and the licensee or applicant has made good faith efforts to comply with the regulation; or
(vi) There is present any other material circumstance not considered when the regulation was adopted for which it would be in the public interest to grant an exemption. If such condition is relied on exclusively for satisfying paragraph (a)(2) of this section, the exemption may not be granted until the Executive Director for Operations has consulted with the Commission.
(b) Any person may request an exemption permitting the conduct of activities prior to the issuance of a construction permit prohibited by § 50.10. The Commission may grant such an exemption upon considering and balancing the following factors:
(1) Whether conduct of the proposed activities will give rise to a significant adverse impact on the environment and the nature and extent of such impact, if any;
(2) Whether redress of any adverse environment impact from conduct of the proposed activities can reasonably be effected should such redress be necessary;
(3) Whether conduct of the proposed activities would foreclose subsequent adoption of alternatives; and
(4) The effect of delay in conducting such activities on the public interest, including the power needs to be used by the proposed facility, the availability of alternative sources, if any, to meet those needs on a timely basis and delay costs to the applicant and to consumers.
An applicant for a license to construct and operate a production or utilization facility, or for an amendment to such license, is not required to provide for design features or other measures for the specific purpose of protection against the effects of (a) attacks and destructive acts, including sabotage, directed against the facility by an enemy of the United States, whether a foreign government or other person, or (b) use or deployment of weapons incident to U.S. defense activities.
Licenses will be issued to named persons applying to the Commission therefor, and will be either class 104 or class 103.
A class 104 license will be issued, to an applicant who qualifies, for any one or more of the following: to transfer or receive in interstate commerce, manufacture, produce, transfer, acquire, possess, or use.
(a) A utilization facility for use in medical therapy; or
(b)(1) A production or utilization facility the construction or operation of which was licensed pursuant to subsection 104b of the Act prior to December 19, 1970;
(2) A production or utilization facility for industrial or commercial purposes constructed or operated under an arrangement with the Administration entered into under the Cooperative Power Reactor Demonstration Program, except as otherwise specifically required by applicable law; and
(3) A production or utilization facility for industrial or commercial purposes, when specifically authorized by law.
(c) A production or utilization facility, which is useful in the conduct of research and development activities of the types specified in section 31 of the Act, and which is not a facility of the type specified in paragraph (b) of this section or in § 50.22.
A class 103 license will be issued, to an applicant who qualifies, for any one or more of the following: To transfer or receive in interstate commerce, manufacture, produce, transfer, acquire, possess, or use a production or utilization facility for industrial or commercial purposes;
A construction permit for the construction of a production or utilization facility will be issued prior to the issuance of a license if the application is otherwise acceptable, and will be converted upon due completion of the facility and Commission action into a license as provided in § 50.56 of this part. A construction permit for the alteration of a production or utilization facility will be issued prior to the issuance of an amendment of a license, if the application for amendment is otherwise acceptable, as provided in § 50.91.
(a)
(2) An additional 10 copies of the general information and 30 copies of the safety analysis report, or part thereof or amendment thereto, must be retained by the applicant for distribution in accordance with the written instructions of the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as appropriate.
(3) Each applicant shall, upon notification by the Atomic Safety and Licensing Board appointed to conduct the public hearing required by the Atomic Energy Act for the issuance of a construction permit, update the application and serve the updated copies of the application or parts of it, eliminating all superseded information, together with an index of the updated application, as directed by the Atomic Safety and Licensing Board. In addition, at that time the applicant shall serve a copy of the updated application on the Atomic Safety and Licensing Appeal Panel. Any subsequent amendment to the application must be served on those served copies of the application and must be submitted to the U.S. Nuclear Regulatory Commission as specified in § 50.4.
(4) The applicant must make a copy of the updated application available at the public hearing for the use of any other parties to the proceeding, and shall certify that the updated copies of the application contain the current contents of the application submitted in accordance with the requirements of this part.
(5) At the time of filing an application, the Commission will make available at the NRC Web site,
(6) The serving of copies required by this section must not occur until the application has been docketed pursuant to § 2.101(a) of this chapter. Copies must be submitted to the Commission, as specified in § 50.4, to enable the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as appropriate, to determine whether the application is sufficiently complete to permit docketing.
(b)
(c) [Reserved]
(d)
(e)
(f)
An applicant may combine in one his several applications for different kinds of licenses under the regulations in this chapter.
In his application, the applicant may incorporate by reference information contained in previous applications, statements or reports filed with the Commission:
Each application shall state:
(a) Name of applicant;
(b) Address of applicant;
(c) Description of business or occupation of applicant;
(d)(1) If applicant is an individual, state citizenship.
(2) If applicant is a partnership, state name, citizenship and address of each partner and the principal location where the partnership does business.
(3) If applicant is a corporation or an unincorporated association, state:
(i) The state where it is incorporated or organized and the principal location where it does business;
(ii) The names, addresses and citizenship of its directors and of its principal officers;
(iii) Whether it is owned, controlled, or dominated by an alien, a foreign corporation, or foreign government, and if so, give details.
(4) If the applicant is acting as agent or representative of another person in filing the application, identify the principal and furnish information required under this paragraph with respect to such principal.
(e) The class of license applied for, the use to which the facility will be put, the period of time for which the license is sought, and a list of other licenses, except operator's licenses, issued or applied for in connection with the proposed facility.
(f) Except for an electric utility applicant for a license to operate a utilization facility of the type described in § 50.21(b) or § 50.22, information sufficient to demonstrate to the Commission the financial qualification of the applicant to carry out, in accordance with regulations in this chapter, the activities for which the permit or license is sought. As applicable, the following should be provided:
(1) If the application is for a construction permit, the applicant shall
(2) If the application is for an operating license, the applicant shall submit information that demonstrates the applicant possesses or has reasonable assurance of obtaining the funds necessary to cover estimated operation costs for the period of the license. The applicant shall submit estimates for total annual operating costs for each of the first five years of operation of the facility. The applicant shall also indicate the source(s) of funds to cover these costs. An application to renew or extend the term of an operating license must include the same financial information as is required in an application for an initial license.
(3) Each application for a construction permit or an operating license submitted by a newly-formed entity organized for the primary purpose of constructing or operating a facility must also include information showing:
(i) The legal and financial relationships it has or proposes to have with its stockholders or owners;
(ii) Its financial ability to meet any contractual obligation to the entity which they have incurred or proposed to incur; and
(iii) Any other information considered necessary by the Commission to enable it to determine the applicant's financial qualification.
(4) The Commission may request an established entity or newly-formed entity to submit additional or more detailed information respecting its financial arrangements and status of funds if the Commission considers this information appropriate. This may include information regarding a licensee's ability to continue the conduct of the activities authorized by the license and to decommission the facility.
(g) If the application is for an operating license for a nuclear power reactor, the applicant shall submit radiological emergency response plans of State and local governmental entities in the United States that are wholly or partially within the plume exposure pathway Emergency Planning Zone (EPZ)
(h) If the applicant proposes to construct or alter a production or utilization facility, the application shall state the earliest and latest dates for completion of the construction or alteration.
(i) If the proposed activity is the generation and distribution of electric energy under a class 103 license, a list of the names and addresses of such regulatory agencies as may have jurisdiction over the rates and services incident to the proposed activity, and a list of trade and news publications which circulate in the area where the proposed activity will be conducted and which are considered appropriate to
(j) If the application contains Restricted Data or other defense information, it shall be prepared in such manner that all Restricted Data and other defense information are separated from the unclassified information.
(k)(1) For an application for an operating license for a production or utilization facility, information in the form of a report, as described in § 50.75 of this part, indicating how reasonable assurance will be provided that funds will be available to decommission the facility.
(2) On or before July 26, 1990, each holder of an operating license for a production or utilization facility in effect on July 27, 1990, shall submit information in the form of a report as described in § 50.75 of this part, indicating how reasonable assurance will be provided that funds will be available to decommission the facility.
(a)(1) An applicant for a construction permit for a nuclear power reactor shall submit the information requested by the Attorney General as described in appendix L to this part, if the application is for a class 103 permit and if the applicant has electrical generating capacity exceeding 1400 MW(e).
(2) An applicant for a construction permit for a nuclear power reactor shall submit the information requested by the Attorney General as described in paragraph 9 of section II of appendix L if the applicant has electrical generating capacity exceeding 200 MW(e) but no more than 1400 MW(e). Upon request of the Commission, the applicant shall furnish the other information described in appendix L.
(3) An applicant for a construction permit for a nuclear power reactor is not required to submit the information described in appendix L unless specifically requested by the Commission to provide the information, if the applicant has electrical generating capacity of 200 MW(e) or less.
(4) The information described in paragraphs (a) (1) and (2) of this section shall be submitted as a separate document prior to any other part of the license application as provided in paragraph (b) and in accordance with § 2.101 of this chapter.
(b) Except as provided in paragraph (d), any person who applies for a class 103 construction permit for a nuclear power reactor on or after July 28, 1975 shall submit the document titled “Information Requested by the Attorney General for Antitrust Review” at least nine (9) months but not more than thirty-six months prior to the date of submittal of any part of the application for a class 103 construction permit.
(c) [Reserved]
(d) Any person who applies for a class 103 construction permit for a nuclear power reactor pursuant to the provisions of § 2.101(a-1) and subpart F of part 2 of this chapter shall submit the document title “Information Requested by the Attorney General for Antitrust Review” at least nine (9) months but not more than thirty-six months prior to the filing of part two or part three of the application, whichever part is filed first, as specified in § 2.101(a-1) of this chapter.
(e) Any person who applies for a class 103 construction permit for a fuel reprocessing plant shall submit the information requested by the Attorney General for antitrust review, as a separate document, as soon as possible and in accordance with § 2.101 of this chapter.
(a)
(1) Stationary power reactor applicants for a construction permit pursuant to this part, or a design certification or combined license pursuant to part 52 of this chapter who apply on or after January 10, 1997, shall comply with paragraph (a)(1)(ii) of this section. All other applicants for a construction permit pursuant to this part or a design certification or combined license pursuant to part 52 of this chapter, shall comply with paragraph (a)(1)(i) of this section.
(i) A description and safety assessment of the site on which the facility is to be located, with appropriate attention to features affecting facility design. Special attention should be directed to the site evaluation factors identified in part 100 of this chapter. The assessment must contain an analysis and evaluation of the major structures, systems and components of the facility which bear significantly on the acceptability of the site under the site evaluation factors identified in part 100 of this chapter, assuming that the facility will be operated at the ultimate power level which is contemplated by the applicant. With respect to operation at the projected initial power level, the applicant is required to submit information prescribed in paragraphs (a)(2) through (a)(8) of this section, as well as the information required by this paragraph, in support of the application for a construction permit, or a design approval.
(ii) A description and safety assessment of the site and a safety assessment of the facility. It is expected that reactors will reflect through their design, construction and operation an extremely low probability for accidents that could result in the release of significant quantities of radioactive fission products. The following power reactor design characteristics and proposed operation will be taken into consideration by the Commission:
(A) Intended use of the reactor including the proposed maximum power level and the nature and inventory of contained radioactive materials;
(B) The extent to which generally accepted engineering standards are applied to the design of the reactor;
(C) The extent to which the reactor incorporates unique, unusual or enhanced safety features having a significant bearing on the probability or consequences of accidental release of radioactive materials;
(D) The safety features that are to be engineered into the facility and those barriers that must be breached as a result of an accident before a release of radioactive material to the environment can occur. Special attention must be directed to plant design features intended to mitigate the radiological consequences of accidents. In performing this assessment, an applicant shall assume a fission product release
(
(
(E) With respect to operation at the projected initial power level, the applicant is required to submit information prescribed in paragraphs (a)(2) through (a)(8) of this section, as well as the information required by this paragraph (a)(1)(i), in support of the application for a construction permit, or a design approval.
(2) A summary description and discussion of the facility, with special attention to design and operating characteristics, unusual or novel design features, and principal safety considerations.
(3) The preliminary design of the facility including:
(i) The principal design criteria for the facility.
(ii) The design bases and the relation of the design bases to the principal design criteria;
(iii) Information relative to materials of construction, general arrangement, and approximate dimensions, sufficient to provide reasonable assurance that the final design will conform to the design bases with adequate margin for safety.
(4) A preliminary analysis and evaluation of the design and performance of structures, systems, and components of the facility with the objective of assessing the risk to public health and safety resulting from operation of the facility and including determination of (i) the margins of safety during normal operations and transient conditions anticipated during the life of the facility, and (ii) the adequacy of structures, systems, and components provided for the prevention of accidents and the mitigation of the consequences of accidents. Analysis and evaluation of ECCS cooling performance following postulated loss-of-coolant accidents shall be performed in accordance with the requirements of § 50.46 of this part for facilities for which construction permits may be issued after December 28, 1974.
(5) An identification and justification for the selection of those variables, conditions, or other items which are determined as the result of preliminary safety analysis and evaluation to be probable subjects of technical specifications for the facility, with special attention given to those items which may significantly influence the final design:
(6) A preliminary plan for the applicant's organization, training of personnel, and conduct of operations.
(7) A description of the quality assurance program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility. Appendix B, “Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,” sets forth the requirements for quality assurance programs for nuclear power plants and fuel reprocessing plants. The description of the quality assurance program for a nuclear power plant or a fuel reprocessing plant shall include a discussion of
(8) An identification of those structures, systems, or components of the facility, if any, which require research and development to confirm the adequacy of their design; and identification and description of the research and development program which will be conducted to resolve any safety questions associated with such structures, systems or components; and a schedule of the research and development program showing that such safety questions will be resolved at or before the latest date stated in the application for completion of construction of the facility.
(9) The technical qualifications of the applicant to engage in the proposed activities in accordance with the regulations in this chapter.
(10) A discussion of the applicant's preliminary plans for coping with emergencies. Appendix E sets forth items which shall be included in these plans.
(11) On or after February 5, 1979, applicants who apply for construction permits for nuclear power plants to be built on multiunit sites shall identify potential hazards to the structures, systems and components important to safety of operating nuclear facilities from construction activities. A discussion shall also be included of any managerial and administrative controls that will be used during construction to assure the safety of the operating unit.
(12) On or after January 10, 1997, stationary power reactor applicants who apply for a construction permit pursuant to this part, or a design certification or combined license pursuant to part 52 of this chapter, as partial conformance to General Design Criterion 2 of appendix A to this part, shall comply with the earthquake engineering criteria in appendix S to this part.
(b)
(1) All current information, such as the results of environmental and meteorological monitoring programs, which has been developed since issuance of the construction permit, relating to site evaluation factors identified in part 100 of this chapter.
(2) A description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, with technical justification therefor, upon which such requirements have been established, and the evaluations required to show that safety functions will be accomplished. The description shall be sufficient to permit understanding of the system designs and their relationship to safety evaluations.
(i) For nuclear reactors, such items as the reactor core, reactor coolant system, instrumentation and control systems, electrical systems, containment system, other engineered safety features, auxiliary and emergency systems, power conversion systems, radioactive waste handling systems, and fuel handling systems shall be discussed insofar as they are pertinent.
(ii) For facilities other than nuclear reactors, such items as the chemical, physical, metallurgical, or nuclear process to be performed, instrumentation and control systems, ventilation and filter systems, electrical systems, auxiliary and emergency systems, and radioactive waste handling systems shall be discussed insofar as they are pertinent.
(3) The kinds and quantities of radioactive materials expected to be produced in the operation and the means for controlling and limiting radioactive effluents and radiation exposures within the limits set forth in part 20 of this chapter.
(4) A final analysis and evaluation of the design and performance of structures, systems, and components with the objective stated in paragraph (a)(4) of this section and taking into account any pertinent information developed since the submittal of the preliminary safety analysis report. Analysis and
(5) A description and evaluation of the results of the applicant's programs, including research and development, if any, to demonstrate that any safety questions identified at the construction permit stage have been resolved.
(6) The following information concerning facility operation:
(i) The applicant's organizational structure, allocations or responsibilities and authorities, and personnel qualifications requirements.
(ii) Managerial and administrative controls to be used to assure safe operation. Appendix B, “Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,” sets forth the requirements for such controls for nuclear power plants and fuel reprocessing plants. The information on the controls to be used for a nuclear power plant or a fuel reprocessing plant shall include a discussion of how the applicable requirements of appendix B will be satisfied.
(iii) Plans for preoperational testing and initial operations.
(iv) Plans for conduct of normal operations, including maintenance, surveillance, and periodic testing of structures, systems, and components.
(v) Plans for coping with emergencies, which shall include the items specified in appendix E.
(vi) Proposed technical specifications prepared in accordance with the requirements of § 50.36.
(vii) On or after February 5, 1979, applicants who apply for operating licenses for nuclear power plants to be operated on multiunit sites shall include an evaluation of the potential hazards to the structures, systems, and components important to safety of operating units resulting from construction activities, as well as a description of the managerial and administrative controls to be used to provide assurance that the limiting conditions for operation are not exceeded as a result of construction activities at the multiunit sites.
(7) The technical qualifications of the applicant to engage in the proposed activities in accordance with the regulations in this chapter.
(8) A description and plans for implementation of an operator requalification program. The operator requalification program must as a minimum, meet the requirements for those programs contained in § 55.59 of part 55 of this chapter.
(9) A description of protection provided against pressurized thermal shock events, including projected values of the reference temperature for reactor vessel beltline materials as defined in § 50.61 (b)(1) and (b)(2).
(10) On or after January 10, 1997, stationary power reactor applicants who apply for an operating license pursuant to this part, or a design certification or combined license pursuant to part 52 of this chapter, as partial conformance to General Design Criterion 2 of appendix A to this part, shall comply with the earthquake engineering criteria of appendix S to this part. However, for those operating license applicants and holders whose construction permit was issued prior to January 10, 1997, the earthquake engineering criteria in section VI of appendix A to part 100 of this chapter continues to apply.
(11) On or after January 10, 1997, stationary power reactor applicants who apply for an operating license pursuant to this part, or a combined license pursuant to part 52 of this chapter, shall provide a description and safety assessment of the site and of the facility as in § 50.34(a)(1)(ii) of this part. However, for either an operating license applicant or holder whose construction permit was issued prior to January 10, 1997, the reactor site criteria in part 100 of this chapter and the seismic and geologic siting criteria in appendix A to part 100 of this chapter continues to apply.
(c) Each application for a license to operate a production or utilization facility must include a physical security plan. The plan must describe how the applicant will meet the requirements of part 73 (and part 11 of this chapter, if applicable, including the identification and description of jobs as required by § 11.11(a), at the proposed facility). The plan must list tests, inspections,
(d)
(e) Each applicant for a license to operate a production or utilization facility, who prepares a physical security plan, a safeguards contingency plan, or a guard qualification and training plan, shall protect the plans and other related Safeguards Information against unauthorized disclosure in accordance with the requirements of § 73.21 of this chapter, as appropriate.
(f)
(1) To satisfy the following requirements, the application shall provide sufficient information to describe the nature of the studies, how they are to be conducted, estimated submittal dates, and a program to ensure that the results of such studies are factored into the final design of the facility. All studies shall be completed no later than two years following issuance of the construction permit or manufacturing license.
(i) Perform a plant/site specific probabilistic risk assessment, the aim of which is to seek such improvements in the reliability of core and containment
(ii) Perform an evaluation of the proposed auxiliary feedwater system (AFWS), to include (applicable to PWR's only) (II.E.1.1):
(A) A simplified AFWS reliability analysis using event-tree and fault-tree logic techniques.
(B) A design review of AFWS.
(C) An evaluation of AFWS flow design bases and criteria.
(iii) Perform an evaluation of the potential for and impact of reactor coolant pump seal damage following small-break LOCA with loss of offsite power. If damage cannot be precluded, provide an analysis of the limiting small-break loss-of-coolant accident with subsequent reactor coolant pump seal damage. (II.K.2.16 and II.K.3.25)
(iv) Perform an analysis of the probability of a small-break loss-of-coolant accident (LOCA) caused by a stuck-open power-operated relief valve (PORV). If this probability is a significant contributor to the probability of small-break LOCA's from all causes, provide a description and evaluation of the effect on small-break LOCA probability of an automatic PORV isolation system that would operate when the reactor coolant system pressure falls after the PORV has opened. (Applicable to PWR's only). (II.K.3.2)
(v) Perform an evaluation of the safety effectiveness of providing for separation of high pressure coolant injection (HPCI) and reactor core isolation cooling (RCIC) system initiation levels so that the RCIC system initiates at a higher water level than the HPCI system, and of providing that both systems restart on low water level. (For plants with high pressure core spray systems in lieu of high pressure coolant injection systems, substitute the words, “high pressure core spray” for “high pressure coolant injection” and “HPCS” for “HPCI”) (Applicable to BWR's only). (II.K.3.13)
(vi) Perform a study to identify practicable system modifications that would reduce challenges and failures of relief valves, without compromising the performance of the valves or other systems. (Applicable to BWR's only). (II.K.3.16)
(vii) Perform a feasibility and risk assessment study to determine the optimum automatic depressurization system (ADS) design modifications that would eliminate the need for manual activation to ensure adequate core cooling. (Applicable to BWR's only). (II.K.3.18)
(viii) Perform a study of the effect on all core-cooling modes under accident conditions of designing the core spray and low pressure coolant injection systems to ensure that the systems will automatically restart on loss of water level, after having been manually stopped, if an initiation signal is still present. (Applicable to BWR's only). (II.K.3.21)
(ix) Perform a study to determine the need for additional space cooling to ensure reliable long-term operation of the reactor core isolation cooling (RCIC) and high-pressure coolant injection (HPCI) systems, following a complete loss of offsite power to the plant for at least two (2) hours. (For plants with high pressure core spray systems in lieu of high pressure coolant injection systems, substitute the words, “high pressure core spray” for “high pressure coolant injection” and “HPCS” for “HPCI”) (Applicable to BWR's only). (II.K.3.24)
(x) Perform a study to ensure that the Automatic Depressurization System, valves, accumulators, and associated equipment and instrumentation will be capable of performing their intended functions during and following an accident situation, taking no credit for non-safety related equipment or instrumentation, and accounting for normal expected air (or nitrogen) leakage through valves. (Applicable to BWR's only). (II.K.3.28)
(xi) Provide an evaluation of depressurization methods, other than by full actuation of the automatic depressurization system, that would reduce the possibility of exceeding vessel integrity limits during rapid cooldown. (Applicable to BWR's only) (II.K.3.45)
(xii) Perform an evaluation of alternative hydrogen control systems that would satisfy the requirements of paragraph (f)(2)(ix) of this section. As a minimum include consideration of a hydrogen ignition and post-accident
(A) A comparison of costs and benefits of the alternative systems considered.
(B) For the selected system, analyses and test data to verify compliance with the requirements of (f)(2)(ix) of this section.
(C) For the selected system, preliminary design descriptions of equipment, function, and layout.
(2) To satisfy the following requirements, the application shall provide sufficient information to demonstrate that the required actions will be satisfactorily completed by the operating license stage. This information is of the type customarily required to satisfy 10 CFR 50.35(a)(2) or to address unresolved generic safety issues.
(i) Provide simulator capability that correctly models the control room and includes the capability to simulate small-break LOCA's. (Applicable to construction permit applicants only) (I.A.4.2.)
(ii) Establish a program, to begin during construction and follow into operation, for integrating and expanding current efforts to improve plant procedures. The scope of the program shall include emergency procedures, reliability analyses, human factors engineering, crisis management, operator training, and coordination with INPO and other industry efforts. (Applicable to construction permit applicants only) (I.C.9)
(iii) Provide, for Commission review, a control room design that reflects state-of-the-art human factor principles prior to committing to fabrication or revision of fabricated control room panels and layouts. (I.D.1)
(iv) Provide a plant safety parameter display console that will display to operators a minimum set of parameters defining the safety status of the plant, capable of displaying a full range of important plant parameters and data trends on demand, and capable of indicating when process limits are being approached or exceeded. (I.D.2)
(v) Provide for automatic indication of the bypassed and operable status of safety systems. (I.D.3)
(vi) Provide the capability of high point venting of noncondensible gases from the reactor coolant system, and other systems that may be required to maintain adequate core cooling. Systems to achieve this capability shall be capable of being operated from the control room and their operation shall not lead to an unacceptable increase in the probability of loss-of-coolant accident or an unacceptable challenge to containment integrity. (II.B.1)
(vii) Perform radiation and shielding design reviews of spaces around systems that may, as a result of an accident, contain accident source term
(viii) Provide a capability to promptly obtain and analyze samples from the reactor coolant system and containment that may contain accident source term
(ix) Provide a system for hydrogen control that can safely accommodate hydrogen generated by the equivalent of a 100% fuel-clad metal water reaction. Preliminary design information on the tentatively preferred system option of those being evaluated in paragraph (f)(1)(xii) of this section is sufficient at the construction permit stage. The hydrogen control system and associated systems shall provide, with reasonable assurance, that: (II.B.8)
(A) Uniformly distributed hydrogen concentrations in the containment do not exceed 10% during and following an accident that releases an equivalent amount of hydrogen as would be generated from a 100% fuel clad metal-water reaction, or that the post-accident atmosphere will not support hydrogen combustion.
(B) Combustible concentrations of hydrogen will not collect in areas where unintended combustion or detonation could cause loss of containment integrity or loss of appropriate mitigating features.
(C) Equipment necessary for achieving and maintaining safe shutdown of the plant and maintaining containment integrity will perform its safety function during and after being exposed to the environmental conditions attendant with the release of hydrogen generated by the equivalent of a 100% fuel-clad metal water reaction including the environmental conditions created by activation of the hydrogen control system.
(D) If the method chosen for hydrogen control is a post-accident inerting system, inadvertent actuation of the system can be safely accommodated during plant operation.
(x) Provide a test program and associated model development and conduct tests to qualify reactor coolant system relief and safety valves and, for PWR's, PORV block valves, for all fluid conditions expected under operating conditions, transients and accidents. Consideration of anticipated transients without scram (ATWS) conditions shall be included in the test program. Actual testing under ATWS conditions need not be carried out until subsequent phases of the test program are developed. (II.D.1)
(xi) Provide direct indication of relief and safety valve position (open or closed) in the control room. (II.D.3)
(xii) Provide automatic and manual auxiliary feedwater (AFW) system initiation, and provide auxiliary feedwater system flow indication in the control room. (Applicable to PWR's only) (II.E.1.2)
(xiii) Provide pressurizer heater power supply and associated motive and control power interfaces sufficient to establish and maintain natural circulation in hot standby conditions with only onsite power available. (Applicable to PWR's only) (II.E.3.1)
(xiv) Provide containment isolation systems that: (II.E.4.2)
(A) Ensure all non-essential systems are isolated automatically by the containment isolation system,
(B) For each non-essential penetration (except instrument lines) have two isolation barriers in series,
(C) Do not result in reopening of the containment isolation valves on resetting of the isolation signal,
(D) Utilize a containment set point pressure for initiating containment isolation as low as is compatible with normal operation,
(E) Include automatic closing on a high radiation signal for all systems that provide a path to the environs.
(xv) Provide a capability for containment purging/venting designed to minimize the purging time consistent with ALARA principles for occupational exposure. Provide and demonstrate high assurance that the purge system will reliably isolate under accident conditions. (II.E.4.4)
(xvi) Establish a design criterion for the allowable number of actuation cycles of the emergency core cooling system and reactor protection system consistent with the expected occurrence rates of severe overcooling events (considering both anticipated transients and accidents). (Applicable to B&W designs only). (II.E.5.1)
(xvii) Provide instrumentation to measure, record and readout in the control room: (A) containment pressure, (B) containment water level, (C) containment hydrogen concentration, (D) containment radiation intensity (high level), and (E) noble gas effluents at all potential, accident release points. Provide for continuous sampling of radioactive iodines and particulates in gaseous effluents from all potential accident release points, and for onsite capability to analyze and measure these samples. (II.F.1)
(xviii) Provide instruments that provide in the control room an unambiguous indication of inadequate core cooling, such as primary coolant saturation meters in PWR's, and a suitable combination of signals from indicators of coolant level in the reactor vessel
(xix) Provide instrumentation adequate for monitoring plant conditions following an accident that includes core damage. (II.F.3)
(xx) Provide power supplies for pressurizer relief valves, block valves, and level indicators such that: (A) Level indicators are powered from vital buses; (B) motive and control power connections to the emergency power sources are through devices qualified in accordance with requirements applicable to systems important to safety and (C) electric power is provided from emergency power sources. (Applicable to PWR's only). (II.G.1)
(xxi) Design auxiliary heat removal systems such that necessary automatic and manual actions can be taken to ensure proper functioning when the main feedwater system is not operable. (Applicable to BWR's only). (II.K.1.22)
(xxii) Perform a failure modes and effects analysis of the integrated control system (ICS) to include consideration of failures and effects of input and output signals to the ICS. (Applicable to B&W-designed plants only). (II.K.2.9)
(xxiii) Provide, as part of the reactor protection system, an anticipatory reactor trip that would be actuated on loss of main feedwater and on turbine trip. (Applicable to B&W-designed plants only). (II.K.2.10)
(xxiv) Provide the capability to record reactor vessel water level in one location on recorders that meet normal post-accident recording requirements. (Applicable to BWR's only). (II.K.3.23)
(xxv) Provide an onsite Technical Support Center, an onsite Operational Support Center, and, for construction permit applications only, a nearsite Emergency Operations Facility. (III.A.1.2).
(xxvi) Provide for leakage control and detection in the design of systems outside containment that contain (or might contain) accident source term
(xxvii) Provide for monitoring of inplant radiation and airborne radioactivity as appropriate for a broad range of routine and accident conditions. (III.D.3.3)
(xxviii) Evaluate potential pathways for radioactivity and radiation that may lead to control room habitability problems under accident conditions resulting in an accident source term
(3) To satisfy the following requirements, the application shall provide sufficient information to demonstrate that the requirement has been met. This information is of the type customarily required to satisfy paragraph (a)(1) of this section or to address the applicant's technical qualifications and management structure and competence.
(i) Provide administrative procedures for evaluating operating, design and construction experience and for ensuring that applicable important industry experiences will be provided in a timely manner to those designing and constructing the plant. (I.C.5)
(ii) Ensure that the quality assurance (QA) list required by Criterion II, app. B, 10 CFR part 50 includes all structures, systems, and components important to safety. (I.F.1)
(iii) Establish a quality assurance (QA) program based on consideration of: (A) Ensuring independence of the organization performing checking functions from the organization responsible for performing the functions; (B) performing quality assurance/quality control functions at construction sites to the maximum feasible extent; (C) including QA personnel in the documented review of and concurrence in quality related procedures associated with design, construction and installation; (D) establishing criteria for determining QA programmatic requirements; (E) establishing qualification requirements for QA and QC personnel; (F) sizing the QA staff commensurate with its duties and responsibilities; (G)
(iv) Provide one or more dedicated containment penetrations, equivalent in size to a single 3-foot diameter opening, in order not to preclude future installation of systems to prevent containment failure, such as a filtered vented containment system. (II.B.8)
(v) Provide preliminary design information at a level of detail consistent with that normally required at the construction permit stage of review sufficient to demonstrate that: (II.B.8)
(A)(
(
(B)(
(vi) For plant designs with external hydrogen recombiners, provide redundant dedicated containment penetrations so that, assuming a single failure, the recombiner systems can be connected to the containment atmosphere. (II.E.4.1)
(vii) Provide a description of the management plan for design and construction activities, to include: (A) The organizational and management structure singularly responsible for direction of design and construction of the proposed plant; (B) technical resources director by the applicant; (C) details of the interaction of design and construction within the applicant's organization and the manner by which the applicant will ensure close integration of the architect engineer and the nuclear steam supply vendor; (D) proposed procedures for handling the transition to operation; (E) the degree of top level management oversight and technical control to be exercised by the applicant
(g)
(ii) Applications for light water cooled nuclear power plant construction permits, manufacturing licenses, and preliminary or final design approvals for standard plants docketed after May 17, 1982 shall include an evaluation of the facility against the SRP in effect on May 17, 1982 or the SRP revision in effect six months prior to the docket date of the application, whichever is later.
(2) The evaluation required by this section shall include an identification and description of all differences in design features, analytical techniques, and procedural measures proposed for a facility and those corresponding features, techniques, and measures given in the SRP acceptance criteria. Where such a difference exists, the evaluation shall discuss how the alternative proposed provides an acceptable method of complying with those rules or regulations of Commission, or portions thereof, that underlie the corresponding SRP acceptance criteria.
(3) The SRP was issued to establish criteria that the NRC staff intends to use in evaluating whether an applicant/licensee meets the Commission's regulations. The SRP is not a substitute for the regulations, and compliance is not a requirement. Applicants shall identify differences from the SRP acceptance criteria and evaluate how the proposed alternatives to the SRP criteria provide an acceptable method of complying with the Commission's regulations.
For
(a) An application for a permit to construct a nuclear power reactor shall include a description of the preliminary design of equipment to be installed to maintain control over radioactive materials in gaseous and liquid effluents produced during normal reactor operations, including expected operational occurrences. In the case of an application filed on or after January 2, 1971, the application shall also identify the design objectives, and the means to be employed, for keeping levels of radioactive material in effluents to unrestricted areas as low as is reasonably achievable. The term “as low as is reasonably achievable” as used in this part means as low as is reasonably achievable taking into account the state of technology, and the economics of improvements in relation to benefits to the public health and safety and other societal and socioeconomic considerations, and in relation to the utilization of atomic energy in the public interest. The guides set out in appendix I to this part provide numerical guidance on design objectives for light-water-cooled nuclear power reactors to meet the requirements that radioactive material in effluents released to unrestricted areas be kept as low as is reasonably achievable. These numerical guides for design objectives and limiting conditions for operation are not to be construed as radiation protection standards.
(b) Each application for a permit to construct a nuclear power reactor shall include:
(1) A description of the preliminary design of equipment to be installed pursuant to paragraph (a) of this section;
(2) An estimate of:
(i) The quantity of each of the principal radio-nuclides expected to be released annually to unrestricted areas in liquid effluents produced during normal reactor operations; and
(ii) The quantity of each of the principal radio-nuclides of the gases, halides, and particulates expected to be released annually to unrestricted areas
(3) A general description of the provisions for packaging, storage, and shipment offsite of solid waste containing radioactive materials resulting from treatment of gaseous and liquid effluents and from other sources.
(c) Each application for a license to operate a nuclear power reactor shall include (1) a description of the equipment and procedures for the control of gaseous and liquid effluents and for the maintenance and use of equipment installed in radioactive waste systems, pursuant to paragraph (a) of this section; an (2) a revised estimate of the information required in paragraph (b)(2) of this section if the expected releases and exposures differ significantly from the estimates submitted in the application for a construction permit.
(a) When an applicant has not supplied initially all of the technical information required to complete the application and support the issuance of a construction permit which approves all proposed design features, the Commission may issue a construction permit if the Commission finds that (1) the applicant has described the proposed design of the facility, including, but not limited to, the principal architectural and engineering criteria for the design, and has identified the major features or components incorporated therein for the protection of the health and safety of the public; (2) such further technical or design information as may be required to complete the safety analysis, and which can reasonably be left for later consideration, will be supplied in the final safety analysis report; (3) safety features or components, if any, which require research and development have been described by the applicant and the applicant has identified, and there will be conducted, a research and development program reasonably designed to resolve any safety questions associated with such features or components; and that (4) on the basis of the foregoing, there is reasonable assurance that, (i) such safety questions will be satisfactorily resolved at or before the latest date stated in the application for completion of construction of the proposed facility, and (ii) taking into consideration the site criteria contained in part 100 of this chapter, the proposed facility can be constructed and operated at the proposed location without undue risk to the health and safety of the public.
When an applicant has supplied initially all of the technical information required to complete the application, including the final design of the facility, the findings required above will be appropriately modified to reflect that fact.
(b) A construction permit will constitute an authorization to the applicant to proceed with construction but will not constitute Commission approval of the safety of any design feature or specification unless the applicant specifically requests such approval and such approval is incorporated in the permit. The applicant, at his option, may request such approvals in the construction permit or, from time to time, by amendment of his construction permit. The Commission may, in its discretion, incorporate in any construction permit provisions requiring the applicant to furnish periodic reports of the progress and results of research and development programs designed to resolve safety questions.
(c) Any construction permit will be subject to the limitation that a license authorizing operation of the facility will not be issued by the Commission until (1) the applicant has submitted to the Commission, by amendment to the application, the complete final safety analysis report, portions of which may be submitted and evaluated from time to time, and (2) the Commission has found that the final design provides reasonable assurance that the health and safety of the public will not be endangered by operation of the facility in accordance with the requirements of
(a) Each applicant for a license authorizing operation of a production or utilization facility shall include in his application proposed technical specifications in accordance with the requirements of this section. A summary statement of the bases or reasons for such specifications, other than those covering administrative controls, shall also be included in the application, but shall not become part of the technical specifications.
(b) Each license authorizing operation of a production or utilization facility of a type described in § 50.21 or § 50.22 will include technical specifications. The technical specifications will be derived from the analyses and evaluation included in the safety analysis report, and amendments thereto, submitted pursuant to § 50.34. The Commission may include such additional technical specifications as the Commission finds appropriate.
(c) Technical specifications will include items in the following categories:
(1)
(B) Safety limits for fuel reprocessing plants are those bounds within which the process variables must be maintained for adequate control of the operation and that must not be exceeded in order to protect the integrity of the physical system that is designed to guard against the uncontrolled release or radioactivity. If any safety limit for a fuel reprocessing plant is exceeded, corrective action must be taken as stated in the technical specification or the affected part of the process, or the entire process if required, must be shut down, unless this action would further reduce the margin of safety. The licensee shall notify the Commission, review the matter, and record the results of the review, including the cause of the condition and the basis for corrective action taken to preclude recurrence. If a portion of the process or the entire process has been shutdown, operation must not be resumed until authorized by the Commission. The licensee shall retain the record of the results of each review until the Commission terminates the license for the plant.
(ii)(A) Limiting safety system settings for nuclear reactors are settings for automatic protective devices related to those variables having significant safety functions. Where a limiting safety system setting is specified for a variable on which a safety limit has been placed, the setting must be so chosen that automatic protective action will correct the abnormal situation before a safety limit is exceeded. If, during operation, it is determined that the automatic safety system does not function as required, the licensee shall take appropriate action, which may include shutting down the reactor. The licensee shall notify the Commission, review the matter, and record the results of the review, including the cause of the condition and the basis for corrective action taken to preclude recurrence. The licensee shall retain the record of the results of each review until the Commission terminates the
(B) Limiting control settings for fuel reprocessing plants are settings for automatic alarm or protective devices related to those variables having significant safety functions. Where a limiting control setting is specified for a variable on which a safety limit has been placed, the setting must be so chosen that protective action, either automatic or manual, will correct the abnormal situation before a safety limit is exceeded. If, during operation, the automatic alarm or protective devices do not function as required, the licensee shall take appropriate action to maintain the variables within the limiting control-setting values and to repair promptly the automatic devices or to shut down the affected part of the process and, if required, to shut down the entire process for repair of automatic devices. The licensee shall notify the Commission, review the matter, and record the results of the review, including the cause of the condition and the basis for corrective action taken to preclude recurrence. The licensee shall retain the record of the results of each review until the Commission terminates the license for the plant.
(2)
(ii) A technical specification limiting condition for operation of a nuclear reactor must be established for each item meeting one or more of the following criteria:
(A)
(B)
(C)
(D)
(iii) A licensee is not required to propose to modify technical specifications that are included in any license issued
(3)
(4)
(5)
(6)
(7)
(i) Licensees that have an installed Emergency Notification System shall make the initial notification to the NRC Operations Center in accordance with § 50.72 of this part.
(ii) All other licensees shall make the initial notification by telephone to the Administrator of the appropriate NRC Regional Office listed in appendix D, part 20, of this chapter.
(8)
(d)(1) This section shall not be deemed to modify the technical specifications included in any license issued prior to January 16, 1969. A license in which technical specifications have not been designated shall be deemed to include the entire safety analysis report as technical specifications.
(2) An applicant for a license authorizing operation of a production or utilization facility to whom a construction permit has been issued prior to January 16, 1969, may submit technical specifications in accordance with this section, or in accordance with the requirements of this part in effect prior to January 16, 1969.
(3) At the initiative of the Commission or the licensee, any license may be amended to include technical specifications of the scope and content which would be required if a new license were being issued.
(e) The provisions of this section apply to each nuclear reactor licensee whose authority to operate the reactor has been removed by license amendment, order, or regulation.
(a) In order to keep releases of radioactive materials to unrestricted areas during normal conditions, including expected occurrences, as low as is reasonably achievable, each licensee of a nuclear power reactor will include technical specifications that, in addition to requiring compliance with applicable provisions of § 20.1301 of this chapter, require that:
(1) Operating procedures developed pursuant to § 50.34a(c) for the control of effluents be established and followed and that the radioactive waste system,
(2) Each licensee shall submit a report to the Commission annually that specifies the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in gaseous effluents during the previous 12 months, including any other information as may be required by the Commission to estimate maximum potential annual radiation doses to the public resulting from effluent releases. The report must be submitted as specified in § 50.4, and the time between submission of the reports must be no longer than 12 months. If quantities of radioactive materials released during the reporting period are significantly above design objectives, the report must cover this specifically. On the basis of these reports and any additional information the Commission may obtain from the licensee or others, the Commission may require the licensee to take action as the Commission deems appropriate.
(b) In establishing and implementing the operating procedures described in paragraph (a) of this section, the licensee shall be guided by the following considerations: Experience with the design, construction, and operation of nuclear power reactors indicates that compliance with the technical specifications described in this section will keep average annual releases of radioactive material in effluents and their resultant committed effective dose equivalents at small percentages of the dose limits specified in § 20.1301 and in the license. At the same time, the licensee is permitted the flexibility of operation, compatible with considerations of health and safety, to assure that the public is provided a dependable source of power even under unusual conditions which may temporarily result in releases higher than such small percentages, but still within the limits specified in § 20.1301 of this chapter and in the license. It is expected that in using this flexibility under unusual conditions, the licensee will exert its best efforts to keep levels of radioactive material in effluents as low as is reasonably achievable. The guides set out in appendix I, provide numerical guidance on limiting conditions for operation for light-water cooled nuclear power reactors to meet the requirement that radioactive materials in effluents released to unrestricted areas be kept as low as is reasonably achievable.
Each license authorizing operation of a production or utilization facility, and each license for a nuclear power reactor facility for which the certification of permanent cessation of operations required under § 50.82(a)(1) has been submitted, which is of a type described in § 50.21(b) (2) or (3) or § 50.22 or is a testing facility, may include conditions to protect the environment to be set out in an attachment to the license which is incorporated in and made a part of the license. These conditions will be derived from information contained in the environmental report and the supplement to the environmental report submitted pursuant to §§ 51.50 and 51.53 of this chapter as analyzed and evaluated in the NRC record of decision, and will identify the obligations of the licensee in the environmental area, including, as appropriate, requirements for reporting and keeping records of environmental data, and any conditions and monitoring requirement for the protection of the nonaquatic environment.
As part of its application and in any event before the receipt of Restricted Data or classified National Security Information or the issuance of a license or construction permit, the applicant shall agree in writing that it will not permit any individual to have access to or any facility to possess Restricted Data or classified National Security Information until the individual and/or facility has been approved for such access under the provisions of 10 CFR parts 25 and/or 95. The agreement of
Any person who is a citizen, national, or agent of a foreign country, or any corporation, or other entity which the Commission knows or has reason to believe is owned, controlled, or dominated by an alien, a foreign corporation, or a foreign government, shall be ineligible to apply for and obtain a license.
Applications and documents submitted to the Commission in connection with applications may be made available for public inspection in accordance with the provisions of the regulations contained in part 2 of this chapter.
In determining that a license will be issued to an applicant, the Commission will be guided by the following considerations:
(a) The processes to be performed, the operating procedures, the facility and equipment, the use of the facility, and other technical specifications, or the proposals, in regard to any of the foregoing collectively provide reasonable assurance that the applicant will comply with the regulations in this chapter, including the regulations in part 20, and that the health and safety of the public will not be endangered.
(b) The applicant is technically and financially qualified to engage in the proposed activities in accordance with the regulations in this chapter. However, no consideration of financial qualification is necessary for an electric utility applicant for an operating license for a utilization facility of the type described in § 50.21(b) or § 50.22.
(c) The issuance of a license to the applicant will not, in the opinion of the Commission, be inimical to the common defense and security or to the health and safety of the public.
(d) Any applicable requirements of subpart A of part 51 have been satisfied.
In determining that a class 104 license will be issued to an applicant, the Commission will, in addition to applying the standards set forth in § 50.40 be guided by the following considerations:
(a) The Commission will permit the widest amount of effective medical therapy possible with the amount of special nuclear material available for such purposes.
(b) The Commission will permit the conduct of widespread and diverse research and development.
(c) An application for a class 104 operating license as to which a person who intervened or sought by timely written notice to the Commission to intervene in the construction permit proceeding for the facility to obtain a determination of antitrust considerations or to advance a jurisdictional basis for such determination has requested an antitrust review under section 105 of the Act within 25 days after the date of publication in the
In determining whether a class 103 license will be issued to an applicant, the Commission will, in addition to applying the standards set forth in § 50.40, be guided by the following considerations:
(a) The proposed activities will serve a useful purpose proportionate to the
(b) Due account will be taken of the advice provided by the Attorney General, under subsection 105c of the Act, and to any evidence that may be provided during any proceedings in connection with the antitrust aspects of the application for a construction permit or the facility's initial operating license.
(1) For this purpose, the Commission will promptly transmit to the Attorney General a copy of the construction permit application or initial operating license application. The Commission will request any advice as the Attorney General considers appropriate in regard to the finding to be made by the Commission as to whether the proposed license would create or maintain a situation inconsistent with the antitrust laws, as specified in subsection 105a of the Act. This requirement will not apply—
(i) With respect to the types of class 103 licenses which the Commission, with the approval of the Attorney general, may determine would not significantly affect the applicant's activities under the antitrust laws; and
(ii) To an application for an initial license to operate a production or utilization facility for which a class 103 construction permit was issued unless the Commission, after consultation with the Attorney General, determines such review is advisable on the ground that significant changes have occurred subsequent to the previous review by the Attorney General and the Commission.
(2) The Commission will publish any advice it receives from the Attorney General in the
In addition to applying the standards set forth in §§ 50.40 and 50.42, in the case of a class 103 license for a facility for the generation of commercial power:
(a) The NRC will:
(1) Give notice in writing of each application to the regulatory agency or State as may have jurisdiction over the rates and services incident to the proposed activity;
(2) Publish notice of the application in trade or news publications as it deems appropriate to give reasonable notice to municipalities, private utilities, public bodies, and cooperatives which might have a potential interest in the utilization or production facility; and
(3) Publish notice of the application once each week for 4 consecutive weeks in the
(b) If there are conflicting applications for a limited opportunity for such license, the Commission will give preferred consideration in the following
(c) The licensee who transmits electric energy in interstate commerce, or sells it at wholesale in interstate commerce, shall be subject to the regulatory provisions of the Federal Power Act.
(d) Nothing herein shall preclude any government agency, now or hereafter authorized by law to engage in the production, marketing, or distribution of electric energy, if otherwise qualified, from obtaining a license for the construction and operation of a utilization facility for the primary purpose of producing electric energy for disposition for ultimate public consumption.
(a) Each boiling or pressurized light-water nuclear power reactor fueled with oxide pellets withincylindrical zircaloy or ZIRLO cladding, must, as provided in paragraphs (b) through (d) of this section, include means for control of hydrogen gas that may be generated, following a postulated loss-of-coolant accident (LOCA) by—
(1) Metal-water reaction involving the fuel cladding and the reactor coolant,
(2) Radiolytic decomposition of the reactor coolant, and
(3) Corrosion of metals.
(b) Each boiling or pressurized light-water nuclear power reactor fueled with oxide pellets within cylindrical zircaloy or ZIRLO cladding must be provided with the capability for—
(1) Measuring the hydrogen concentration in the containment,
(2) Insuring a mixed atmosphere in the containment, and
(3) Controlling combustible gas concentrations in the containment following a postulated LOCA.
(c)(1) For each boiling or pressurized light-water nuclear power reactor fueled with oxide pellets within cylindrical zircaloy or ZIRLO cladding, it must be shown that during the time period following a postulated LOCA, but prior to effective operation of the combustible gas control system, either:
(i) An uncontrolled hydrogen-oxygen recombi-nation would not take place in the containment; or
(ii) The plant could withstand the consequences of uncontrolled hydrogen-oxygen recombination without loss of safety function.
(2) If the conditions set out in paragraph (c)(1) of this section cannot be shown, the containment shall be provided with an inerted or an oxygen deficient atmosphere in order to provide protection against hydrogen burning and explosions during the time period specified in paragraph (c)(1) of this section.
(3) Notwithstanding paragraphs (c)(1) and (c)(2) of this section:
(i) Effective May 4, 1982 or 6 months after initial criticality, whichever is later, an inerted atmosphere shall be provided for each boiling light-water nuclear power reactor with a Mark I or Mark II type containment; and
(ii) By the end of the first scheduled outage beginning after July 5, 1982 and of sufficient duration to permit required modifications, each light-water nuclear power reactor that relies upon a purge/repressurization system as the primary means for controlling combustible gases following a LOCA shall be provided with either an internal recombiner or the capability to install an external recombiner following the start of an accident. The internal or external recombiners must meet the combustible gas control requirements in paragraph (d) of this section. The containment penetrations used for external recombiners must either be:
(A) Dedicated to that service only, conform to the requirements of Criteria 54 and 56 of appendix A of this part, be designed against postulated
(B) Of a combined design for use by either external recombiners or purge/repressurization systems and other systems, conform to the requirements of criteria 54 and 56 of appendix A of this part, be designed against postulated single failures both for containment isolation purposes and for operation of the external recombiners or purge/repressurization systems, and be sized to satisfy the flow requirements of the external recombiners or purge repressurization systems.
(iii) To provide improved operational capability to maintain adequate core cooling following an accident, by the end of the first scheduled outage beginning after July 1, 1982 and of sufficient duration to permit required modifications, each light-water nuclear power reactor shall be provided with high point vents for the reactor coolant system, for the reactor vessel head, and for other systems required to maintain adequate core cooling if the accumulation of noncondensible gases would cause the loss of function of these systems. (High point vents are not required, however, for the tubes in U-tube steam generators.) The high point vents must be remotely operated from the control room. Since these vents form a part of the reactor coolant pressure boundary, the design of the vents and associated controls, instruments and power sources must conform to the requirements of appendix A and appendix B of this part. In particular, the vent system shall be designed to ensure a low probability that (A) the vents will not perform their safety functions and (B) there would be inadvertent or irreversible actuation of a vent. Furthermore, the use of these vents during and following an accident must not aggravate the challenge to the containment or the course of the accident.
(iv)(A) Each licensee with a boiling light-water nuclear power reactor with a Mark III type of containment and each licensee with a pressurized light-water nuclear power reactor with an ice condenser type of containment issued a construction permit before March 28, 1979, shall provide its nuclear power reactor with a hydrogen control system justified by a suitable program of experiment and analysis. The hydrogen control system must be capable of handling without loss of containment structural integrity an amount of hydrogen equivalent to that generated from a metal-water reaction involving 75% of the fuel cladding surrounding the active fuel region (excluding the cladding surrounding the plenum volume).
(B) Containment structural integrity must be demonstrated by use of an analytical technique that is accepted by the NRC staff. This demonstration must include sufficient supporting justification to show that the technique describes the containment response to the structural loads involved. This method could include the use of actual material properties with suitable margins to account for uncertainties in modeling, in material properties, in construction tolerances, and so on. Another method could include a showing that the following specific criteria of the ASME Boiler and Pressure Vessel Code are met:
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(C) Subsubarticle NE-3220, Division 1, and Subsubarticle CC-3720, Division 2, of Section III of the ASME Boiler and Pressure Vessel Code, referenced in paragraphs (c)(3)(iv)(B)(
(D) If the hydrogen control system relies on post-accident inerting, the containment structure must be capable of withstanding the increased pressure:
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(
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(E) If the hydrogen control system relies on post-accident inerting, the systems and components required to establish and maintain safe shutdown and containment integrity must be designed and qualified for the environment caused by such inerting. Furthermore, inadvertent full inerting during normal plant operations must not adversely affect systems and components needed for safe operation of the plant.
(v)(A) Each licensee with a boiling light-water nuclear power reactor with a Mark III type of containment and each licensee with a pressurized light-water nuclear power reactor with an ice condenser type of containment issued a construction permit before March 28, 1979, for a reactor that does not rely upon an inerted atmosphere to control hydrogen inside the containment, shall provide its nuclear power reactor with systems and components necessary to establish and maintain safe shutdown and to maintain containment integrity. These systems and components must be capable of performing their functions during and after exposure to the environmental conditions created by the burning of hydrogen. Environmental conditions caused by local detonations of hydrogen must also be included, unless such detonations can be shown unlikely to occur.
(B) The amount of hydrogen to be considered is equivalent to that generated from a metal-water reaction involving 75% of the fuel cladding surrounding the active fuel region (excluding the cladding surrounding the plenum volume).
(vi)(A) Each applicant for or holder of an operating license for a boiling light-water nuclear power reactor with a Mark III type of containment or for a pressurized light-water nuclear power reactor with an ice condenser type of containment issued a construction permit before March 28, 1979, shall submit an analysis to the Commission as specified in § 50.4.
(B) The analysis required by paragraph (c)(3)(vi)(A) of this section must:
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(
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(vii)(A) By June 25, 1985, each applicant for or holder of an operating license subject to the requirements of paragraphs (c)(3) (iv), (v) and (vi) of this section shall develop and submit to the Commission a proposed schedule for meeting these requirements. The schedule may be developed using integrated scheduling systems previously approved for the facility by the NRC.
(B) For each applicant for an operating license as of Febuary 25, 1985, the schedule shall provide for compliance with the requirements of paragraph (c)(3)(iv)(A) of this section prior to operation of the reactor in excess of 5 percent power. Completed final analyses are not necessary for a staff determination that a plant is safe to operate at full power provided that prior to such operation an applicant has provided a preliminary analysis which the staff has determined provides a satisfactory basis for a decision to support interim operation at full power until the final analysis has been completed. However, the record in this rulemaking shows that such preliminary analyses are not necessary for a staff determination that a plant is safe to operate at full power if the staff has determined for similar plants, referenced in this notice of rulemaking, that similar systems provide a satisfactory basis for a decision to support operation at full power until the preliminary analyses have been completed.
(C) For those holders of operating licenses containing license conditions on Hydrogen Control Measures covered by this section, the schedule shall be consistent with those license conditions, or approved amendments thereto.
(D) For those facilities not having an NRC approved integrated scheduling system, a final schedule for meeting the requirements of paragraphs (c)(3) (iv), (v) and (vi) of this section shall be established by the NRC staff within 90 days of receipt of a proposed schedule from the licensee or applicant, taking into account the current status of efforts at the facility to comply with the requirements; analyses that may be provided by applicants or licensees regarding the impacts of these requirements on other scheduled plant modifications, including any NRC-mandated safety modifications, and their relative importance to safety; and the Commission's objective that these requirements be complied with without undue delay.
(d)(1) For facilities that are in compliance with § 50.46(b), the amount of hydrogen contributed by core metal-water reaction (percentage of fuel cladding that reacts with water), as a result of degradation, but not total failure, of emergency core cooling functioning shall be assumed either to be five times the total amount of hydrogen calculated in demonstrating compliance with § 50.46(b)(3), or to be the amount that would result from reaction of all the metal in the outside surfaces of the cladding cylinders surrounding the fuel (excluding the cladding surrounding the plenum volume) to a depth of 0.00023 inch (0.0058 mm), whichever amount is greater. A time period of 2 minutes shall be used as the interval after the postulated LOCA over which the metal-water reaction occurs.
(2) For facilities as to which no evaluation of compliance in accordance with § 50.46(b) has been submitted and evaluated, the amounts of hydrogen so contributed shall be assumed to be that amount resulting from the reaction of 5 percent of the mass of metal in the cladding cylinders surrounding the fuel, excluding the cladding surrounding the plenum volume.
(e) For facilities whose notice of hearing on the application for a construction permit was published on or after November 5, 1970, purging and/or repressurization shall not be the primary means for controlling combustible gases following a LOCA. However, the capability for controlled purging shall be provided. For these facilities, the primary means for controlling combustible gases following a LOCA shall consist of a combustible gas control system, such as recombiners, that does not result in a significant release from containment.
(f) For facilities with respect to which the notice of hearing on the application for a construction permit was published between December 22, 1968, and November 5, 1970, if the incremental radiation dose from purging (and repressurization if a repressurization system is provided) occurring at all points beyond the exclusion area boundary after a postulated LOCA calculated in accordance with § 100.11(a)(2) of this chapter is less than 2.5 rem to the whole body and less than 30 rem to the thyroid, and if the combined radiation dose at the low population zone outer boundary from purging and the postulated LOCA calculated in accordance with § 100.11(a)(2) of this chapter is less than 25 rem to the whole body and less than 300 rem to the thyroid, only a purging system is necessary, provided that the purging system and any filtration system associated with it are designed to conform with the general requirements of Criteria 41, 42, and 43 of appendix A to this part. Otherwise the facility shall be provided with another type of combustible gas control system (a repressurization system is acceptable) designed to conform with the general requirements of Criteria 41, 42, and 43 of appendix A to this part. If a purge system is used as part of the repressurization system, the purge system shall be designed to conform with the general requirements of Criteria 41, 42, and 43 of appendix A to this part. The containment shall not be repressurized beyond 50 percent of the containment design pressure.
(g) For facilities with respect to which the notice of hearing on the application for a construction permit was published on or before December 22, 1968, if the combined radiation dose at the low population zone outer boundary from purging (and repressurization if a repressurization system is provided) and the postulated LOCA calculated in accordance with § 100.11(a)(2) of this chapter is less than 25 rem to the whole body and less than 300 rem to the thyroid, only a purging system is necessary, provided that the purging system and any filtration system associated with it are designed to conform with the general requirements of Criteria 41, 42, and 43 of appendix A to this part. Otherwise, the facility shall be provided with another type of combustible gas control system (a repressurization system is acceptable) designed to conform with the general requirements of Criteria 41, 42, and 43 of appendix A to this part. If a purge system is used as part of the repressurization system, it shall be designed to conform with the general requirements of Criteria 41, 42, and 43 of appendix A to this part. The containment shall not be repressurized beyond 50 percent of the containment design pressure.
(h) As used in this section: (1) Degradation, but not total failure, of emergency core cooling functioning means that the performance of the emergency core cooling system is postulated, for purposes of design of the combustible gas control system, not to meet the acceptance criteria in § 50.46 and that there could be localized clad melting and metal-water reaction to the extent postulated in paragraph (d) of this section. The degree of performance degradation is not postulated to be sufficient to cause core meltdown.
(2) A combustible gas control system is a system that operates after a LOCA to maintain the concentrations of combustible gases within the containment, such as hydrogen, below flammability limits. Combustible gas control systems are of two types: (i) Systems that allow controlled release from containment, through filters if necessary, such as purging systems and repressurization systems, and (ii) systems that do not result in a significant release from containment such as recombiners.
(3) A purging system is a system for the controlled release of the containment atmosphere to the environment through filters if needed.
(4) A repressurization system is a system used to dilute the concentration of combustible gas within containment by adding inert gas or air to the containment. Dilution of the combustible gas results in a delay in time until a flammable concentration is reached and permits fission product decay. Operation is limited to a containment repressurization to 50 percent of the containment design pressure. A
An applicant for a license or an amendment of a license who proposes to construct or alter a production or utilization facility will be initially granted a construction permit, if the application is in conformity with and acceptable under the criteria of §§ 50.31 through 50.38 and the standards of §§ 50.40 through 50.43.
(a)(1)(i) Each boiling or pressurized light-water nuclear power reactor fueled with uranium oxide pellets within cylindrical zircaloy or ZIRLO cladding must be provided with an emergency core cooling system (ECCS) that must be designed so that its calculated cooling performance following postulated loss-of-coolant accidents conforms to the criteria set forth in paragraph (b) of this section. ECCS cooling performance must be calculated in accordance with an acceptable evaluation model and must be calculated for a number of postulated loss-of-coolant accidents of different sizes, locations, and other properties sufficient to provide assurance that the most severe postulated loss-of-coolant accidents are calculated. Except as provided in paragraph (a)(1)(ii) of this section, the evaluation model must include sufficient supporting justification to show that the analytical technique realistically describes the behavior of the reactor system during a loss-of-coolant accident. Comparisons to applicable experimental data must be made and uncertainties in the analysis method and inputs must be identified and assessed so that the uncertainty in the calculated results can be estimated. This uncertainty must be accounted for, so that, when the calculated ECCS cooling performance is compared to the criteria set forth in paragraph (b) of this section, there is a high level of probability that the criteria would not be exceeded. Appendix K, Part II Required Documentation, sets forth the documentation requirements for each evaluation model. This section does not apply to a nuclear power reactor facility for which the certifications required under § 50.82(a)(1) have been submitted.
(ii) Alternatively, an ECCS evaluation model may be developed in conformance with the required and acceptable features of appendix K ECCS Evaluation Models.
(2) The Director of Nuclear Reactor Regulation may impose restrictions on reactor operation if it is found that the evaluations of ECCS cooling performance submitted are not consistent with paragraphs (a)(1) (i) and (ii) of this section.
(3)(i) Each applicant for or holder of an operating license or construction permit shall estimate the effect of any change to or error in an acceptable evaluation model or in the application of such a model to determine if the change or error is significant. For this purpose, a significant change or error is one which results in a calculated peak fuel cladding temperature different by more than 50 °F from the temperature calculated for the limiting transient using the last acceptable model, or is a cumulation of changes and errors such that the sum of the absolute magnitudes of the respective temperature changes is greater than 50 °F.
(ii) For each change to or error discovered in an acceptable evaluation model or in the application of such a model that affects the temperature calculation, the applicant or licensee shall report the nature of the change or error and its estimated effect on the limiting ECCS analysis to the Commission at least annually as specified in § 50.4. If the change or error is signficant, the applicant or licensee shall provide this report within 30 days and include with the report a proposed schedule for providing a reanalysis or taking other action as may be needed to show compliance with § 50.46 requirements. This schedule may be developed using an integrated scheduling system
(b)(1)
(2)
(3)
(4)
(5)
(c) As used in this section: (1) Loss-of-coolant accidents (LOCA's) are hypothetical accidents that would result from the loss of reactor coolant, at a rate in excess of the capability of the reactor coolant makeup system, from breaks in pipes in the reactor coolant pressure boundary up to and including a break equivalent in size to the double-ended rupture of the largest pipe in the reactor coolant system.
(2) An evaluation model is the calculational framework for evaluating the behavior of the reactor system during a postulated loss-of-coolant accident (LOCA). It includes one or more computer programs and all other information necessary for application of the calculational framework to a specific LOCA, such as mathematical models used, assumptions included in the programs, procedure for treating the program input and output information, specification of those portions of analysis not included in computer programs, values of parameters, and all other information necessary to specify the calculational procedure.
(d) The requirements of this section are in addition to any other requirements applicable to ECCS set forth in this part. The criteria set forth in paragraph (b), with cooling performance calculated in accordance with an acceptable evaluation model, are in implementation of the general requirements with respect to ECCS cooling performance design set forth in this
(a)(1) Except as provided in paragraph (d) of this section, no initial operating license for a nuclear power reactor will be issued unless a finding is made by the NRC that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. No finding under this section is necessary for issuance of a renewed nuclear power reactor operating license.
(2) The NRC will base its finding on a review of the Federal Emergency Management Agency (FEMA) findings and determinations as to whether State and local emergency plans are adequate and whether there is reasonable assurance that they can be implemented, and on the NRC assessment as to whether the applicant's onsite emergency plans are adequate and whether there is reasonable assurance that they can be implemented. A FEMA finding will primarily be based on a review of the plans. Any other information already available to FEMA may be considered in assessing whether there is reasonable assurance that the plans can be implemented. In any NRC licensing proceeding, a FEMA finding will constitute a rebuttable presumption on questions of adequacy and implementation capability.
(b) The onsite and, except as provided in paragraph (d) of this section, offsite emergency response plans for nuclear power reactors must meet the following standards:
(1) Primary responsibilities for emergency response by the nuclear facility licensee and by State and local organizations within the Emergency Planning Zones have been assigned, the emergency responsibilities of the various supporting organizations have been specifically established, and each principal response organization has staff to respond and to augment its initial response on a continuous basis.
(2) On-shift facility licensee responsibilities for emergency response are unambiguously defined, adequate staffing to provide initial facility accident response in key functional areas is maintained at all times, timely augmentation of response capabilities is available and the interfaces among various onsite response activities and offsite support and response activities are specified.
(3) Arrangements for requesting and effectively using assistance resources have been made, arrangements to accommodate State and local staff at the licensee's near-site Emergency Operations Facility have been made, and other organizations capable of augmenting the planned response have been identified.
(4) A standard emergency classification and action level scheme, the bases of which include facility system and effluent parameters, is in use by the nuclear facility licensee, and State and local response plans call for reliance on information provided by facility licensees for determinations of minimum initial offsite response measures.
(5) Procedures have been established for notification, by the licensee, of State and local response organizations and for notification of emergency personnel by all organizations; the content of initial and followup messages to response organizations and the public has been established; and means to provide early notification and clear instruction to the populace within the plume exposure pathway Emergency Planning Zone have been established.
(6) Provisions exist for prompt communications among principal response organizations to emergency personnel and to the public.
(7) Information is made available to the public on a periodic basis on how they will be notified and what their initial actions should be in an emergency (e.g., listening to a local broadcast station and remaining indoors), the principal points of contact with the news media for dissemination of information during an emergency (including the physical location or locations) are established in advance, and procedures for coordinated dissemination of information to the public are established.
(8) Adequate emergency facilities and equipment to support the emergency response are provided and maintained.
(9) Adequate methods, systems, and equipment for assessing and monitoring actual or potential offsite consequences of a radiological emergency condition are in use.
(10) A range of protective actions has been developed for the plume exposure pathway EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidance, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed.
(11) Means for controlling radiological exposures, in an emergency, are established for emergency workers. The means for controlling radiological exposures shall include exposure guidelines consistent with EPA Emergency Worker and Lifesaving Activity Protective Action Guides.
(12) Arrangements are made for medical services for contaminated injured individuals.
(13) General plans for recovery and reentry are developed.
(14) Periodic exercises are (will be) conducted to evaluate major portions of emergency response capabilities, periodic drills are (will be) conducted to develop and maintain key skills, and deficiencies identified as a result of exercises or drills are (will be) corrected.
(15) Radiological emergency response training is provided to those who may be called on to assist in an emergency.
(16) Responsibilities for plan development and review and for distribution of emergency plans are established, and planners are properly trained.
(c)(1) Failure to meet the applicable standards set forth in paragraph (b) of this section may result in the Commission declining to issue an operating license; however, the applicant will have an opportunity to demonstrate to the satisfaction of the Commission that deficiencies in the plans are not significant for the plant in question, that adequate interim compensating actions have been or will be taken promptly, or that there are other compelling reasons to permit plant operations. Where an applicant for an operating license asserts that its inability to demonstrate compliance with the requirements of paragraph (b) of this sectionresults wholly or substantially from the decision of stateand/or local governments not to participate further in emergency planning, an operating license may be issued if the applicant demonstrates to the Commission's satisfaction that:
(i) The applicant's inability to comply with the requirements of paragraph (b) of this section is wholly or substantially the result of the non-participation of state and/or local governments.
(ii) The applicant has made a sustained, good faith effort to secure and retain the participation of the pertinent state and/or local governmental authorities, including the furnishing of copies of its emergency plan.
(iii) The applicant's emergency plan provides reasonable assurance that public health and safety is not endangered by operation of the facility concerned. To make that finding, the applicant must demonstrate that, as outlined below, adequate protective measures can and will be taken in the event of an emergency. A utility plan will be evaluated against the same planning standards applicable to a state or local plan, as listed in paragraph (b) of this section, with due allowance made both for—
(A) Those elements for which state and/or local non-participation makes compliance infeasible and
(B) The utility's measures designed to compensate for any deficiencies resulting from state and/or local non-participation.
(2) Generally, the plume exposure pathway EPZ for nuclear power plants shall consist of an area about 10 miles (16 km) in radius and the ingestion pathway EPZ shall consist of an area about 50 miles (80 km) in radius. The exact size and configuration of the EPZs surrounding a particular nuclear power reactor shall be determined in relation to local emergency response needs and capabilities as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries. The size of the EPZs also may be determined on a case-by-case basis for gas-cooled nuclear reactors and for reactors with an authorized power level less than 250 MW thermal. The plans for the ingestion pathway shall focus on such actions as are appropriate to protect the food ingestion pathway.
(d) Notwithstanding the requirements of paragraphs (a) and (b) of this section, and except as specified by this paragraph, no NRC or FEMA review, findings, or determinations concerning the state of offsite emergency preparedness or the adequacy of and capability to implement State and local or utility offsite emergency plans are required prior to issuance of an operating license authorizing only fuel loading or low power testing and training (up to 5 percent of the rated power). Insofar as emergency planning and preparedness requirements are concerned, a license authorizing fuel loading and/or low power testing and training may be issued after a finding is made by the NRC that the state of onsite emergency preparedness provides reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. The NRC will base this finding on its assessment of the applicant's onsite emergency plans against the pertinent standards in paragraph (b) of this section and appendix E. Review of applicant's emergencyplans will include the following standards with offsite aspects:
(1) Arrangements for requesting and effectively using offsite assistance on site have been made, arrangements to accommodate State and local staff at the licensee's near-site Emergency Operations Facility have been made, and other organizations capable of augmenting the planned onsite response have been identified.
(2) Procedures have been established for licensee communications with State and local response organizations, including initial notification of the declaration of emergency and periodic provision of plant and response status reports.
(3) Provisions exist for prompt communications among principal response organizations to offsite emergency personnel who would be responding onsite.
(4) Adequate emergency facilities and equipment to support the emergency response onsite are provided and maintained.
(5) Adequate methods, systems, and equipment for assessing and monitoring actual or potential offsite consequences of a radiological emergency condition are in use onsite.
(6) Arrangements are made for medical services for contaminated and injured onsite individuals.
(7) Radiological emergency response training has been made available to those offsite who may be called to assist in an emergency onsite.
(a)(1) Each operating nuclear power plant must have a fire protection plan that satisfies Criterion 3 of appendix A to this part. This fire protection plan must:
(i) Describe the overall fire protection program for the facility;
(ii) Identify the various positions within the licensee's organization that are responsible for the program;
(iii) State the authorities that are delegated to each of these positions to implement those responsibilities; and
(iv) Outline the plans for fire protection, fire detection and suppression capability, and limitation of fire damage.
(2) The plan must also describe specific features necessary to implement the program described in paragraph (a)(1) of this section such as—
(i) Administrative controls and personnel requirements for fire prevention and manual fire suppression activities;
(ii) Automatic and manually operated fire detection and suppression systems; and
(iii) The means to limit fire damage to structures, systems, or components important to safety so that the capability to shut down the plant safely is ensured.
(3) The licensee shall retain the fire protection plan and each change to the plan as a record until the Commission terminates the reactor license. The licensee shall retain each superseded revision of the procedures for 3 years from the date it was superseded.
(b) Appendix R to this part establishes fire protection features required to satisfy Criterion 3 of appendix A to this part with respect to certain generic issues for nuclear power plants licensed to operate before January 1, 1979.
(1) Except for the requirements of Sections III.G, III.J, and III.O, the provisions of Appendix R to this part do not apply to nuclear power plants licensed to operate before January 1, 1979, to the extent that—
(i) Fire protection features proposed or implemented by the licensee have been accepted by the NRC staff as satisfying the provisions of Appendix A to Branch Technical Position (BTP) APCSB 9.5-1 reflected in NRC fire protection safety evaluation reports issued before the effective date of February 19, 1981; or
(ii) Fire protection features were accepted by the NRC staff in comprehensive fire protection safety evaluation reports issued before Appendix A to Branch Technical Position (BTP) APCSB 9.5-1 was published in August 1976.
(2) With respect to all other fire protection features covered by Appendix R, all nuclear power plants licensed to operate before January 1, 1979, must satisfy the applicable requirements of Appendix R to this part, including specifically the requirements of Sections III.G, III.J, and III.O.
(c)-(e) [Reserved]
(f) Licensees that have submitted the certifications required under § 50.82(a)(1) shall maintain a fire protection program to address the potential for fires that could cause the release or spread of radioactive materials (i.e., that could result in a radiological hazard).
(1) The objectives of the fire protection program are to—
(i) Reasonably prevent these fires from occurring;
(ii) Rapidly detect, control, and extinguish those fires that do occur and that could result in a radiological hazard; and
(iii) Ensure that the risk of fire-induced radiological hazards to the public, environment and plant personnel is minimized.
(2) The licensee shall assess the fire protection program on a regular basis. The licensee shall revise the plan as appropriate throughout the various stages of facility decommissioning.
(3) The licensee may make changes to the fire protection program without NRC approval if these changes do not reduce the effectiveness of fire protection for facilities, systems, and equipment that could result in a radiological hazard, taking into account the decommissioning plant conditions and activities.
(a) Each holder of or an applicant for a license for a nuclear power plant, other than a nuclear power plant for which the certifications required under § 50.82(a)(1) have been submitted, shall establish a program for qualifying the electric equipment defined in paragraph (b) of this section.
(b) Electric equipment important to safety covered by this section is:
(1) Safety-related electric equipment.
(i) This equipment is that relied upon to remain functional during and following design basis events to ensure—
(A) The integrity of the reactor coolant pressure boundary;
(B) The capability to shut down the reactor and maintain it in a safe shutdown condition; or
(C) The capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposures comparable to the guidelines in § 50.34(a)(1), § 50.67(b)(2), or § 100.11 of this chapter, as applicable.
(ii) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be designed to ensure functions (b)(1)(i) (A) through (C) of this section.
(2) Nonsafety-related electric equipment whose failure under postulated environmental conditions could prevent satisfactory accomplishment of safety functions specified in subparagraphs (b)(1)(i)(A) through (C) of this section by the safety-related equipment.
(3) Certain post-accident monitoring equipment.
(c) Requirements for (1) dynamic and seismic qualification of electric equipment important to safety, (2) protection of electric equipment important to safety against other natural phenomena and external events, and (3) environmental qualification of electric equipment important to safety located in a mild environment are not included within the scope of this section. A mild environment is an environment that would at no time be significantly more severe than the environment that would occur during normal plant operation, including anticipated operational occurrences.
(d) The applicant or licensee shall prepare a list of electric equipment important to safety covered by this section. In addition, the applicant or licensee shall include the information in paragraphs (d)(1), (2), and (3) of this section for this electric equipment important to safety in a qualification file. The applicant or licensee shall keep the list and information in the file current and retain the file in auditable form for the entire period during which the covered item is installed in the nuclear power plant or is stored for future use to permit verification that each item of electric equipment is important to safely meet the requirements of paragraph (j) of this section.
(1) The performance specifications under conditions existing during and following design basis accidents.
(2) The voltage, frequency, load, and other electrical characteristics for which the performance specified in accordance with paragraph (d)(1) of this section can be ensured.
(3) The environmental conditions, including temperature, pressure, humidity, radiation, chemicals, and submergence at the location where the equipment must perform as specified in accordance with paragraphs (d) (1) and (2) of this section.
(e) The electric equipment qualification program must include and be based on the following:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(f) Each item of electric equipment important to safety must be qualified by one of the following methods:
(1) Testing an identical item of equipment under identical conditions or under similar conditions with a supporting analysis to show that the equipment to be qualified is acceptable.
(2) Testing a similar item of equipment with a supporting analysis to show that the equipment to be qualified is acceptable.
(3) Experience with identical or similar equipment under similar conditions with a supporting analysis to show that the equipment to be qualified is acceptable.
(4) Analysis in combination with partial type test data that supports the analytical assumptions and conclusions.
(g) Each holder of an operating license issued prior to February 22, 1983, shall, by May 20, 1983, identify the electric equipment important to safety within the scope of this section already qualified and submit a schedule for either the qualification to the provisions of this section or for the replacement of the remaining electric equipment important to safety within the scope of this section. This schedule must establish a goal of final environmental qualification of the electric equipment within the scope of this section by the end of the second refueling outage after March 31, 1982 or by March 31, 1985, whichever is earlier. The Director of the Office of Nuclear Reactor Regulation may grant requests for extensions of this deadline to a date no later than November 30, 1985, for specific pieces of equipment if these requests are filed on a timely basis and demonstrate good cause for the extension, such as procurement lead time, test complications, and installation problems. In exceptional cases, the Commission itself may consider and grant extensions beyond November 30, 1985, for completion of environmental qualification.
(h) Each license shall notify the Commission as specified in § 50.4 of any significant equipment qualification problem that may require extension of
(i) Applicants for operating licenses granted after February 22, 1983, but prior to November 30, 1985, shall perform an analysis to ensure that the plant can be safely operated pending completion of equipment qualification required by this section. This analysis must be submitted, as specified in § 50.4, for consideration prior to the granting of an operating license and must include, where appropriate, consideration of:
(1) Accomplishing the safety function by some designated alternative equipment if the principal equipment has not been demonstrated to be fully qualified.
(2) The validity of partial test data in support of the original qualification.
(3) Limited use of administrative controls over equipment that has not been demonstrated to be fully qualified.
(4) Completion of the safety function prior to exposure to the accident environment resulting from a design basis event and ensuring that the subsequent failure of the equipment does not degrade any safety function or mislead the operator.
(5) No significant degradation of any safety function or misleading information to the operator as a result of failure of equipment under the accident environment resulting from a design basis event.
(j) A record of the qualification, including documentation in paragraph (d) of this section, must be maintained in an auditable form for the entire period during which the covered item is installed in the nuclear power plant or is stored for future use to permit verification that each item of electric equipment important to safety covered by this section:
(1) Is qualified for its application; and
(2) Meets its specified performance requirements when it is subjected to the conditions predicted to be present when it must perform its safety function up to the end of its qualified life.
(k) Applicants for and holders of operating licenses are not required to requalify electric equipment important to safety in accordance with the provisions of this section if the Commission has previously required qualification of that equipment in accordance with “Guidelines for Evaluating Environmental Qualification of Class 1E Electrical Equipment in Operating Reactors,” November 1979 (DOR Guidelines), or NUREG-0588 (For Comment version), “Interim Staff Position on Environmental Qualification of Safety-Related Electrical Equipment.”
(l) Replacement equipment must be qualified in accordance with the provisions of this section unless there are sound reasons to the contrary.
Upon determination that an application for a license meets the standards and requirements of the act and regulations, and that notifications, if any, to other agencies or bodies have been duly made, the Commission will issue a license, or if appropriate a construction permit, in such form and containing such conditions and limitations including technical specifications, as it deems appropriate and necessary.
(a) Each license will be issued for a fixed period of time to be specified in the license but in no case to exceed 40 years from date of issuance. Where the operation of a facility is involved, the Commission will issue the license for the term requested by the applicant or for the estimated useful life of the facility if the Commission determines that the estimated useful life is less than the term requested. Where construction of a facility is involved, the Commission may specify in the construction permit the period for which the license will be issued if approved
(b) Each license for a facility that has permanently ceased operations, continues in effect beyond the expiration date to authorize ownership and possession of the production or utilization facility, until the Commission notifies the licensee in writing that the license is terminated. During such period of continued effectiveness the licensee shall—
(1) Take actions necessary to decommission and decontaminate the facility and continue to maintain the facility, including, where applicable, the storage, control and maintenance of the spent fuel, in a safe condition, and
(2) Conduct activities in accordance with all other restrictions applicable to the facility in accordance with the NRC regulations and the provisions of the specific 10 CFR part 50 license for the facility.
The Commission may combine in a single license the activities of an applicant which would otherwise be licensed severally.
No license under this part shall be deemed to have been issued for activities which are not under or within the jurisdiction of the United States.
Whether stated therein or not, the following shall be deemed conditions in every license issued:
(a)(1) Each nuclear power plant or fuel reprocessing plant licensee subject to the quality assurance criteria in appendix B of this part shall implement, pursuant to § 50.34(b)(6)(ii) of this part, the quality assurance program described or referenced in the Safety Analysis Report, including changes to that report.
(2) Each licensee described in paragraph (a)(1) of this section shall, by June 10, 1983, submit to the appropriate NRC Regional Office shown in appendix D of part 20 of this chapter the current description of the quality assurance program it is implementing for inclusion in the Safety Analysis Report, unless there are no changes to the description previously accepted by NRC. This submittal must identify changes made to the quality assurance program description since the description was submitted to NRC. (Should a licensee need additional time beyond June 10, 1983 to submit its current quality assurance program description to NRC, it shall notify the appropriate NRC Regional Office in writing, explain why additional time is needed, and provide a schedule for NRC approval showing when its current quality assurance program description will be submitted.)
(3) Each licensee described in paragraph (a)(1) of this section may make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report without prior NRC approval, provided the change does not reduce the commitments in the program description as accepted by the NRC. Changes to the quality assurance program description that do not reduce the commitments must be submitted to the NRC in accordance with the requirements of § 50.71(e). In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, the following changes are not considered to be reductions in commitment:
(i) The use of a QA standard approved by the NRC which is more recent than the QA standard in the licensee's current QA program at the time of the change;
(ii) The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility;
(iii) The use of generic organizational position titles that clearly denote the
(iv) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text;
(v) The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the licensee is committed; and
(vi) Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.
(4) Changes to the quality assurance program description that do reduce the commitments must be submitted to the NRC and receive NRC approval prior to implementation, as follows:
(i) Changes made to the quality assurance program description as presented in the Safety Analysis Report or in a topical report must be submitted as specified in § 50.4.
(ii) The submittal of a change to the Safety Analysis Report quality assurance program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of this part and the Safety Analysis Report quality assurance program description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).
(iii) A copy of the forwarding letter identifying the change must be maintained as a facility record for three years.
(iv) Changes to the quality assurance program description included or referenced in the Safety Analysis Report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first.
(b) No right to the special nuclear material shall be conferred by the license except as may be defined by the license.
(c) Neither the license, nor any right thereunder, nor any right to utilize or produce special nuclear material shall be transferred, assigned, or disposed of in any manner, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission shall, after securing full information, find that the transfer is in accordance with the provisions of the act and give its consent in writing.
(d) The license shall be subject to suspension and to the rights of recapture of the material or control of the facility reserved to the Commission under section 108 of the act in a state of war or national emergency declared by Congress.
(e) The license shall be subject to revocation, suspension, modification, or amendment for cause as provided in the act and regulations, in accordance with the procedures provided by the act and regulations.
(f) The licensee shall at any time before expiration of the license, upon request of the Commission, submit, as specified in § 50.4, written statements, signed under oath or affirmation, to enable the Commission to determine whether or not the license should be modified, suspended, or revoked. Except for information sought to verify licensee compliance with the current licensing basis for that facility, the NRC must prepare the reason or reasons for each information request prior to issuance to ensure that the burden to be imposed on respondents is justified in view of the potential safety significance of the issue to be addressed in the requested information. Each such justification provided for an evaluation performed by the NRC staff must be approved by the Executive Director for Operations or his or her designee prior to issuance of the request.
(g) The issuance or existence of the license shall not be deemed to waive, or relieve the licensee from compliance with, the antitrust laws, as specified in
(h) The license shall be subject to the provisions of the Act now or hereafter in effect and to all rules, regulations, and orders of the Commission. The terms and conditions of the license shall be subject to amendment, revision, or modification, by reason of amendments of the Act or by reason of rules, regulations, and orders issued in accordance with the terms of the act.
(i) Except as provided in § 55.13 of this chapter, the licensee may not permit the manipulation of the controls of any facility by anyone who is not a licensed operator or senior operator as provided in part 55 of this chapter.
(i-1) Within three months after issuance of an operating license, the licensee shall have in effect an operator requalification program which must as a minimum, meet the requirements of § 55.59(c) of this chapter. Notwithstanding the provisions of § 50.59, the licensee may not, except as specifically authorized by the Commission decrease the scope of an approved operator requalification program.
(j) Apparatus and mechanisms other than controls, the operation of which may affect the reactivity or power level of a reactor shall be manipulated only with the knowledge and consent of an operator or senior operator licensed pursuant to part 55 of this chapter present at the controls.
(k) An operator or senior operator licensed pursuant to part 55 of this chapter shall be present at the controls at all times during the operation of the facility.
(l) The licensee shall designate individuals to be responsible for directing the licensed activities of licensed operators. These individuals shall be licensed as senior operators pursuant to part 55 of this chapter.
(m)(1) A senior operator licensed pursuant to part 55 of this chapter shall be present at the facility or readily available on call at all times during its operation, and shall be present at the facility during initial start-up and approach to power, recovery from an unplanned or unscheduled shut-down or significant reduction in power, and refueling, or as otherwise prescribed in the facility license.
(2) Notwithstanding any other provisions of this section, by January 1, 1984, licensees of nuclear power units shall meet the following requirements:
(i) Each licensee shall meet the minimum licensed operator staffing requirements in the following table:
(ii) Each licensee shall have at its site a person holding a senior operator license for all fueled units at the site who is assigned responsibility for overall plant operation at all times there is fuel in any unit. If a single senior operator does not hold a senior operator license on all fueled units at the site, then the licensee must have at the site two or more senior operators, who in combination are licensed as senior operators on all fueled units.
(iii) When a nuclear power unit is in an operational mode other than cold shutdown or refueling, as defined by the unit's technical specifications, each licensee shall have a person holding a senior operator license for the nuclear power unit in the control room at all times. In addition to this senior operator, for each fueled nuclear power unit, a licensed operator or senior operator shall be present at the controls at all times.
(iv) Each licensee shall have present, during alteration of the core of a nuclear power unit (including fuel loading or transfer), a person holding a senior operator license or a senior operator license limited to fuel handling to directly supervise the activity and, during this time, the licensee shall not assign other duties to this person.
(3) Licensees who cannot meet the January 1, 1984 deadline must submit by October 1, 1983 a request for an extension to the Director of the Office of Nuclear Regulation and demonstrate good cause for the request.
(n) The licensee shall not, except as authorized pursuant to a construction permit, make any alteration in the facility constituting a change from the technical specifications previously incorporated in a license or construction permit pursuant to § 50.36 of this part.
(o) Primary reactor containments for water cooled power reactors, other than facilities for which the certifications required under § 50.82(a)(1) have been submitted, shall be subject to the requirements set forth in appendix J to this part.
(p)(1) The licensee shall prepare and maintain safeguards contingency plan procedures in accordance with appendix C of part 73 of this chapter for effecting the actions and decisions contained in the Responsibility Matrix of the safeguards contingency plan. The licensee may make no change which would decrease the effectiveness of a security plan, or guard training and qualification plan, prepared pursuant to § 50.34(c) or part 73 of this chapter, or of the first four categories of information (Background, Generic Planning Base, Licensee Planning Base, Responsibility Matrix) contained in a licensee safeguards contingency plan prepared pursuant to § 50.34(d) or part 73 of this chapter, as applicable, without prior approval of the Commission. A licensee desiring to make such a change shall submit an application for an amendment to the licensee's license pursuant to § 50.90.
(2) The licensee may make changes to the plans referenced in paragraph (p)(1) of this section, without prior Commission approval if the changes do not decrease the safeguards effectiveness of the plan. The licensee shall maintain records of changes to the plans made without prior Commission approval for a period of three years from the date of the change, and shall submit, as specified in § 50.4, a report containing a description of each change within two months after the change is made. Prior to the safeguards contingency plan being put into effect, the licensee shall have:
(i) All safeguards capabilities specified in the safeguards contingency plan available and functional,
(ii) Detailed procedures developed according to appendix C to part 73 available at the licensee's site, and
(iii) All appropriate personnel trained to respond to safeguards incidents as outlined in the plan and specified in the detailed procedures.
(3) The licensee shall provide for the development, revision, implementation, and maintenance of its safeguards contingency plan. The licensee shall ensure that all program elements are reviewed by individuals independent of both security program management and personnel who have direct responsibility for implementation of the security program either:
(i) At intervals not to exceed 12 months, or
(ii) As necessary, based on an assessment by the licensee against performance indicators, and as soon as reasonably practicable after a change occurs in personnel, procedures, equipment, or facilities that potentially could adversely affect security, but no longer than 12 months after the change. In any case, all elements of the safeguards contingency plan must be reviewed at least once every 24 months.
(4) The review must include a review and audit of safeguards contingency procedures and practices, an audit of the security system testing and maintenance program, and a test of the safeguards systems along with commitments established for response by local law enforcement authorities. The results of the review and audit, along with recommendations for improvements, must be documented, reported to the licensee's corporate and plant management, and kept available at the plant for inspection for a period of 3 years.
(q) A licensee authorized to possess and operate a nuclear power reactor shall follow and maintain in effect emergency plans which meet the standards in § 50.47(b) and the requirements in appendix E of this part. A licensee authorized to possess and/or operate a research reactor or a fuel facility shall follow and maintain in effect emergency plans which meet the requirements in appendix E to this part. The licensee shall retain the emergency plan and each change that decreases the effectiveness of the plan as a record until the Commission terminates the license for the nuclear power reactor. The nuclear power reactor licensee may make changes to these plans without Commission approval only if the changes do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the standards of § 50.47(b) and the requirements of appendix E to this part. The research reactor and/or the fuel facility licensee may make changes to these plans without Commission approval only if these changes do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the requirements of appendix E to this part. This nuclear power reactor, research reactor, or fuel facility licensee shall retain a record of each change to the emergency plan made without prior Commission approval for a period of three years from the date of the change. Proposed changes that decrease the effectiveness of the approved emergency plans may not be implemented without application to and approval by the Commission. The licensee shall submit, as specified in § 50.4, a report of each proposed change for approval. If a change is made without approval, the licensee shall submit, as specified in § 50.4, a report of each change within 30 days after the change is made.
(r) Each licensee who is authorized to possess and/or operate a research or test reactor facility with an authorized power level greater than or equal to 2 MW thermal, under a licensee of the type specified in § 50.21(c), shall submit emergency plans complying with 10 CFR part 50, appendix E, to the Director of the Office of Nuclear Reactor Regulation for approval by September 7, 1982. Each licensee who is authorized to possess and/or operate a research or test reactor facility with an authorized power level less than 2 MW thermal, under a license of the type specified in § 50.21(c), shall submit emergency plans complying with 10 CFR part 50, appendix E, to the Director of the Office of Nuclear Reactor Regulation for approval by November 3, 1982.
(s)(1) Each licensee who is authorized to possess and/or operate a nuclear power reactor shall submit to NRC within 60 days of the effective date of this amendment the radiological emergency response plans of State and local governmental entities in the United States that are wholly or partially within a plume exposure pathway EPZ, as well as the plans of State governments wholly or partially within an ingestion pathway EPZ.
(2)(i) For operating power reactors, the licensee, State, and local emergency response plans shall be implemented by April 1, 1981, except as provided in section IV.D.3 of appendix E to this part.
(ii) If after April 1, 1981, the NRC finds that the state of emergency preparedness does not provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency (
(3) The NRC will base its finding on a review of the FEMA findings and determinations as to whether State and local emergency plans are adequate and capable of being implemented, and on the NRC assessment as to whether the licensee's emergency plans are adequate and capable of being implemented. Nothing in this paragraph shall be construed as limiting the authority of the Commission to take action under any other regulation or authority of the Commission or at any time other than that specified in this paragraph.
(t)(1) The licensee shall provide for the development, revision, implementation, and maintenance of its emergency preparedness program. The licensee shall ensure that all program elements are reviewed by persons who have no direct responsibility for the implementation of the emergency preparedness program either:
(i) At intervals not to exceed 12 months or,
(ii) As necessary, based on an assessment by the licensee against performance indicators, and as soon as reasonably practicable after a change occurs in personnel, procedures, equipment, or facilities that potentially could adversely affect emergency preparedness, but no longer than 12 months after the change. In any case, all elements of the emergency preparedness program must be reviewed at least once every 24 months.
(2) The review must include an evaluation for adequacy of interfaces with State and local governments and of licensee drills, exercises, capabilities, and procedures. The results of the review, along with recommendations for improvements, must be documented, reported to the licensee's corporate and plant management, and retained for a period of 5 years. The part of the review involving the evaluation for adequacy of interface with State and local governments must be available to the appropriate State and local governments.
(u) Within 60 days after the effective date of this amendment, each nuclear power reactor licensee shall submit to the NRC plans for coping with emergencies that meet standards in § 50.47(b) and the requirements of appendix E to this part.
(v) Each licensee subject to the requirements of part 73 of this chapter shall ensure that physical security, safeguards contingency and guard qualification and training plans and other related Safeguards Information are protected against unauthorized disclosure in accordance with the requirements of § 73.21 of this chapter, as appropriate.
(w) Each power reactor licensee under this part for a production or utilization facility of the type described in § 50.21(b) or § 50.22 shall take reasonable steps to obtain insurance available at reasonable costs and on reasonable terms from private sources or to demonstrate to the satisfaction of the NRC that it possesses an equivalent amount of protection covering the licensee's obligation, in the event of an accident at the licensee's reactor, to stabilize and decontaminate the reactor and the reactor station site at which the reactor experiencing the accident is located, provided that:
(1) The insurance required by paragraph (w) of this section must have a minimum coverage limit for each reactor station site of either $1.06 billion or whatever amount of insurance is generally available from private sources, whichever is less. The required insurance must clearly state that, as and to the extent provided in paragraph (w)(4) of this section, any proceeds must be payable first for stabilization of the reactor and next for decontamination of the reactor and the reactor station site. If a licensee's coverage falls below the required minimum, the licensee shall within 60 days take all reasonable steps to restore its coverage to the required minimum. The required insurance may, at the option of the licensee, be included within policies that also provide coverage for other risks, including, but not limited to, the risk of direct physical damage.
(2)(i) With respect to policies issued or annually renewed on or after April 2, 1991, the proceeds of such required insurance must be dedicated, as and to the extent provided in this paragraph, to reimbursement or payment on behalf of the insured of reasonable expenses incurred or estimated to be incurred by the licensee in taking action to fulfill the licensee's obligation, in the event of an accident at the licensee's reactor, to ensure that the reactor is in, or is returned to, and maintained in, a safe and stable condition and that radioactive contamination is removed or controlled such that personnel exposures are consistent with the occupational exposure limits in 10 CFR part 20. These actions must be consistent with any other obligation the licensee may have under this chapter and must be subject to paragraph (w)(4) of this section. As used in this section, an “accident” means an event that involves the release of radioactive material from its intended place of confinement within the reactor or on the reactor station site such that there is a present danger of release off site in amounts that would pose a threat to the public health and safety.
(ii) The stabilization and decontamination requirements set forth in paragraph (w)(4) of this section must apply uniformly to all insurance policies required under paragraph (w) of this section.
(3) The licensee shall report to the NRC on April 1 of each year the current levels of this insurance or financial security it maintains and the sources of this insurance or financial security.
(4)(i) In the event of an accident at the licensee's reactor, whenever the estimated costs of stabilizing the licensed reactor and of decontaminating the reactor and the reactor station site exceed $100 million, the proceeds of the insurance required by paragraph (w) of this section must be dedicated to and used, first, to ensure that the licensed reactor is in, or is returned to, and can be maintained in, a safe and stable condition so as to prevent any significant risk to the public health and safety and, second, to decontaminate the reactor and the reactor station site in accordance with the licensee's cleanup plan as approved by order of the Director of the Office of Nuclear Reactor Regulation. This priority on insurance
(A) Shutdown of the reactor;
(B) Establishment and maintenance of long-term cooling with stable decay heat removal;
(C) Maintenance of sub-criticality;
(D) Control of radioactive releases; and
(E) Securing of structures, systems, or components to minimize radiation exposure to onsite personnel or to the offsite public or to facilitate later decontamination or both.
(ii) The licensee shall inform the Director of the Office of Nuclear Reactor Regulation in writing when the reactor is and can be maintained in a safe and stable condition so as to prevent any significant risk to the public health and safety. Within 30 days after the licensee informs the Director that the reactor is in this condition, or at such earlier time as the licensee may elect or the Director may for good cause direct, the licensee shall prepare and submit a cleanup plan for the Director's approval. The cleanup plan must identify and contain an estimate of the cost of each cleanup operation that will be required to decontaminate the reactor sufficiently to permit the licensee either to resume operation of the reactor or to apply to the Commission under § 50.82 for authority to decommission the reactor and to surrender the license voluntarily. Cleanup operations may include one or more of the following, as appropriate:
(A) Processing any contaminated water generated by the accident and by decontamination operations to remove radioactive materials;
(B) Decontamination of surfaces inside the auxiliary and fuel-handling buildings and the reactor building to levels consistent with the Commission's occupational exposure limits in 10 CFR part 20, and decontamination or disposal of equipment;
(C) Decontamination or removal and disposal of internal parts and damaged fuel from the reactor vessel; and
(D) Cleanup of the reactor coolant system.
(iii) Following review of the licensee's cleanup plan, the Director will order the licensee to complete all operations that the Director finds are necessary to decontaminate the reactor sufficiently to permit the licensee either to resume operation of the reactor or to apply to the Commission under § 50.82 for authority to decommission the reactor and to surrender the license voluntarily. The Director shall approve or disapprove, in whole or in part for stated reasons, the licensee's estimate of cleanup costs for such operations. Such order may not be effective for more than 1 year, at which time it may be renewed. Each subsequent renewal order, if imposed, may be effective for not more than 6 months.
(iv) Of the balance of the proceeds of the required insurance not already expended to place the reactor in a safe and stable condition pursuant to paragraph (w)(2)(i) of this section, an amount sufficient to cover the expenses of completion of those decontamination operations that are the subject of the Director's order shall be dedicated to such use, provided that, upon certification to the Director of the amounts expended previously and from time to time for stabilization and decontamination and upon further certification to the Director as to the sufficiency of the dedicated amount remaining, policies of insurance may provide for payment to the licensee or other loss payees of amounts not so dedicated, and the licensee may proceed to use in parallel (and not in preference thereto) any insurance proceeds not so dedicated for other purposes.
(x) A licensee may take reasonable action that departs from a license condition or a technical specification (contained in a license issued under this part) in an emergency when this action is immediately needed to protect the public health and safety and no action consistent with license conditions and
(y) Licensee action permitted by paragraph (x) of this section shall be approved, as a minimum, by a licensed senior operator, or, at a nuclear power reactor facility for which the certifications required under § 50.82(a)(1) have been submitted, by either a licensed senior operator or a certified fuel handler, prior to taking the action.
(z) Each licensee with a utilization facility licensed pursuant to sections 103 or 104b. of the Act shall immediately notify the NRC Operations Center of the occurrence of any event specified in § 50.72 of this part.
(aa) The license shall be subject to all conditions deemed imposed as a matter of law by sections 401(a)(2) and 401(d) of the Federal Water Pollution Control Act, as amended (33 U.S.C.A. 1341 (a)(2) and (d).)
(bb) For nuclear power reactors licensed by the NRC, the licensee shall, within 2 years following permanent cessation of operation of the reactor or 5 years before expiration of the reactor operating license, whichever occurs first, submit written notification to the Commission for its review and preliminary approval of the program by which the licensee intends to manage and provide funding for the management of all irradiated fuel at the reactor following permanent cessation of operation of the reactor until title to the irradiated fuel and possession of the fuel is transferred to the Secretary of Energy for its ultimate disposal in a repository. Licensees of nuclear power reactors that have permanently ceased operation by April 4, 1994 are required to submit such written notification by April 4, 1996. Final Commission review will be undertaken as part of any proceeding for continued licensing under part 50 or part 72 of this chapter. The licensee must demonstrate to NRC that the elected actions will be consistent with NRC requirements for licensed possession of irradiated nuclear fuel and that the actions will be implemented on a timely basis. Where implementation of such actions requires NRC authorizations, the licensee shall verify in the notification that submittals for such actions have been or will be made to NRC and shall identify them. A copy of the notification shall be retained by the licensee as a record until expiration of the reactor operating license. The licensee shall notify the NRC of any significant changes in the proposed waste management program as described in the initial notification.
(cc)(1) Each licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against:
(i) The licensee;
(ii) An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or
(iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.
(2) This notification must indicate:
(i) The bankruptcy court in which the petition for bankruptcy was filed; and
(ii) The date of the filing of the petition.
(dd) A licensee may take reasonable action that departs from a license condition or a technical specification (contained in a license issued under this part) in a national security emergency:
(1) When this action is immediately needed to implement national security objectives as designated by the national command authority through the Commission, and
(2) No action consistent with license conditions and technical specifications that can meet national security objectives is immediately apparent.
(ee)(1) Each license issued under this part authorizing the possession of byproduct and special nuclear material produced in the operation of the licensed reactor includes, whether stated in the license or not, the authorization to receive back that same material, in the same or altered form or combined with byproduct or special nuclear material produced in the operation of another reactor of the same licensee located at that site, from a licensee of the Commission or an Agreement State, or from a non-licensed entity authorized to possess the material.
(2) The authorizations in this subsection are subject to the same limitations and requirements applicable to the original possession of the material.
(3) This paragraph does not authorize the receipt of any material recovered from the reprocessing of irradiated fuel.
(ff) For licensees of nuclear power plants that have implemented the earthquake engineering criteria in appendix S to this part, plant shutdown is required as provided in paragraph IV(a)(3) of appendix S to this part. Prior to resuming operations, the licensee shall demonstrate to the Commission that no functional damage has occurred to those features necessary for continued operation without undue risk to the health and safety of the public and the licensing basis is maintained.
For
Each construction permit shall be subject to the following terms and conditions:
(a) The permit shall state the earliest and latest dates for completion of the construction or modification.
(b) If the proposed construction or modification of the facility is not completed by the latest completion date, the permit shall expire and all rights thereunder shall be forfeited:
(c) Except as modified by this section and § 50.55a, the construction permit shall be subject to the same conditions to which a license is subject.
(d) At or about the time of completion of the construction or modification of the facility, the applicant will file any additional information needed to bring the original application for license up to date, and will file an application for an operating license or an amendment to an application for a license to construct and operate the facility for the issuance of an operating license, as appropriate, as specified in § 50.30(d) of this part.
(e)(1) Each individual, corporation, partnership, or other entity holding a facility construction permit subject to this part must adopt appropriate procedures to—
(i) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (e)(1)(ii) of this section, in all cases within 60 days of discovery, in order to identify a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected.
(ii) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the Commission through a director or responsible officer or designated person as discussed in paragraph (e)(7) of this section. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in
(iii) Ensure that a director or responsible officer of the holder of a facility construction permit subject to this part is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in paragraph (e)(1)(i) or (e)(1)(ii) of this section, if the construction of a facility or activity, or a basic component supplied for such facility or activity—
(A) Fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to a substantial safety hazard,
(B) Contains a defect, or
(C) Undergoes any significant breakdown in any portion of the quality assurance program conducted pursuant to the requirements of appendix B to 10 CFR part 50 which could have produced a defect in a basic component. Such breakdowns in the quality assurance program are reportable whether or not the breakdown actually resulted in a defect in a design approved and released for construction or installation.
(2) The holder of a facility construction permit subject to this part who obtains information reasonably indicating that the facility fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to a substantial safety hazard must notify the Commission of the failure to comply through a director or responsible officer or designated person as discussed in paragraph (e)(7) of this section.
(3) The holder of a facility construction permit subject to this part who obtains information reasonably indicating the existence of any defect found in construction or any defect found in the final design of a facility as approved and released for construction must notify the Commission of the defect through a director or responsible officer or designated person as discussed in paragraph (e)(7) of this section.
(4) The holder of a facility construction permit subject to this part who obtains information reasonably indicating that the quality assurance program has undergone any significant breakdown discussed in paragraph (e)(1)(ii)(C) of this section must notify the Commission of the breakdown in the quality assurance program through a director or responsible officer or designated person as discussed in paragraph (e)(7) of this section.
(5) The notification requirements of paragraphs (e)(2), (e)(3), and (e)(4) of this section apply to all defects and failures to comply associated with a substantial safety hazard regardless of whether extensive evaluation, redesign, or repair is required to conform to the criteria and bases stated in the safety analysis report or construction permit. Evaluation of potential defects and failures to comply and reporting of defects and failures to comply under this section satisfies the construction permit holder's evaluation and notification obligations under part 21 of this chapter and, satisfies the responsibility of individual directors or responsible officers of holders of construction permits issued under § 50.23 of this chapter to report defects, and failures to comply associated with substantial safety hazards under section 206 of the Energy Reorganization Act of 1974.
(6) The notification required by paragraphs (e)(2), (e)(3), and (e)(4) of this section must consist of—
(i) Initial notification by facsimile, which is the preferred method of notification, to the NRC Operations Center at (301) 816-5151 or by telephone at (301) 816-5100 within two days following receipt of information by the director or responsible corporate officer under paragraph (e)(1)(iii) of this section, on the identification of a defect or a failure to comply. Verification that the facsimile has been received should be made by calling the NRC Operations Center. This paragraph does not apply to interim reports described in paragraph (e)(1)(ii).
(ii) Written notification submitted to the Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555, with a copy to the appropriate Regional Administrator at the address specified in appendix D to part 20 of this chapter and a copy to the appropriate NRC resident inspector
(7) The director or responsible officer may authorize an individual to provide the notification required by this section, provided that this must not relieve the director or responsible officer of his or her responsibility under this section.
(8) The written notification required by paragraph (e)(6)(ii) of this section must clearly indicate that the written notification is being submitted under § 50.55(e) and include the following information, to the extent known—
(i) Name and address of the individual or individuals informing the Commission.
(ii) Identification of the facility, the activity, or the basic component supplied for the facility or the activity within the United States which contains a defect or fails to comply.
(iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.
(iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.
(v) The date on which the information of such defect or failure to comply was obtained.
(vi) In the case of a basic component which contains a defect or fails to comply, the number and location of all the components in use at the facility subject to the regulations in this part.
(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
(viii) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to other entities.
(9) The holder of a construction permit must prepare and maintain records necessary to accomplish the purposes of this section, specifically —
(i) Retain procurement documents, which define the requirements that facilities or basic components must meet in order to be considered acceptable, for the lifetime of the basic component.
(ii) Retain evaluations of all deviations and failures to comply for a minimum of five years.
(iii) Maintaining records in accordance with this section satisfies the construction permit holders recordkeeping obligations under part 21 of this chapter. The recordkeeping obligations of responsible officers and directors under part 21 of this chapter are met by recordkeeping in accordance with this section.
(10) The requirements of this § 50.55(e) are satisfied when the defect or failure to comply associated with a substantial safety hazard has been previously reported under part 21 of this chapter or under § 73.71 of this chapter under § 50.55(e) or § 50.73 of this part. For holders of construction permits issued prior to October 29, 1991. Evaluation, reporting and recordkeeping requirements of § 50.55(e) may be met by complying with the comparable requirements of part 21 of this chapter.
(f)(1) Each nuclear power plant or fuel reprocessing plant construction permit holder subject to the quality assurance criteria in appendix B of this part shall implement, pursuant to § 50.34(a)(7) of this part, the quality assurance program described or referenced in the Safety Analysis Report, including changes to that report.
(2) Each construction permit holder described in paragraph (f)(1) of this section shall, by June 10, 1983, submit to the appropriate NRC Regional Office shown in appendix D of part 20 of this chapter the current description of the quality assurance program it is implementing for inclusion in the Safety Analysis Report, unless there are no changes to the description previously accepted by NRC. This submittal must identify changes made to the quality assurance program description since the description was submitted to NRC.
(3) After March 11, 1983, each construction permit holder described in paragraph (f)(1) of this section may make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report, provided the change does not reduce the commitments in the program description previously accepted by the NRC. Changes to the quality assurance program description that do not reduce the commitments must be submitted to NRC within 90 days. Changes to the quality assurance program description that do reduce the commitments must be submitted to NRC and receive NRC approval before implementation, as follows:
(i) Changes to the Safety Analysis Report must be submitted for review as specified in § 50.4. Changes made to NRC-accepted quality assurance topical report descriptions must be submitted as specified in § 50.4.
(ii) The submittal of a change to the Safety Analysis Report quality assurance program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of this part and the Safety Analysis Report quality assurance program description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).
(iii) A copy of the forwarding letter identifying the changes must be maintained as a facility record for three years.
(iv) Changes to the quality assurance program description included or referenced in the Safety Analysis Report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first.
Each operating license for a boiling or pressurized water-cooled nuclear power facility is subject to the conditions in paragraphs (f) and (g) of this section and each construction permit for a utilization facility is subject to the following conditions in addition to those specified in § 50.55.
(a)(1) Structures, systems, and components must be designed, fabricated, erected, constructed, tested, and inspected to quality standards commensurate with the importance of the safety function to be performed.
(2) Systems and components of boiling and pressurized water-cooled nuclear power reactors must meet the requirements of the ASME Boiler and Pressure Vessel Code specified in paragraphs (b), (c), (d), (e), (f), and (g) of this section. Protection systems of nuclear power reactors of all types must meet the requirements specified in paragraph (h) of this section.
(3) Proposed alternatives to the requirements of paragraphs (c), (d), (e), (f), (g), and (h) of this section or portions thereof may be used when authorized by the Director of the Office of Nuclear Reactor Regulation. The applicant shall demonstrate that:
(i) The proposed alternatives would provide an acceptable level of quality and safety, or
(ii) Compliance with the specified requirements of this section would result in hardship or unusual difficulty without a compensating increase in the level of quality and safety.
(b) The ASME Boiler and Pressure Vessel Code, and the ASME Code for Operation and Maintenance of Nuclear Power Plants, which are referenced in
(1) As used in this section, references to Section III of the ASME Boiler and Pressure Vessel Code refer to Section III, and include the 1963 Edition through 1973 Winter Addenda, and the 1974 Edition (Division 1) through the 2000 Addenda (Division 1), subject to the following limitations and modifications:
(i)
(ii)
(iii)
(iv)
(v)
(2) As used in this section, references to Section XI of the ASME Boiler and Pressure Vessel Code refer to Section XI, and include the 1970 Edition through the 1976 Winter Addenda, and the 1977 Edition (Division 1) through the 2000 Addenda (Division 1), subject to the following limitations and modifications:
(i)
(ii)
(iii)
(iv)
(B) For a nuclear power plant whose application for a construction permit was docketed prior to July 1, 1978, when applying editions and addenda up to the 1983 Edition through the Summer 1983 Addenda of section XI of the ASME Code, the extent of examination for Code Class 2 pipe welds may be determined by the requirements of paragraph IWC-1220, Table IWC-2520 Category C-F and C-G and paragraph IWC-2411 in the 1974 Edition and Addenda through the Summer 1975 Addenda of Section XI of the ASME Code or other requirements the Commission may adopt.
(v) Evaluation procedures and acceptance criteria for austenitic piping (applies to IWB-3640). When applying the Winter 1983 Addenda and Winter 1984 Addenda, the rules of paragraph IWB-3640 may be used for all applications permitted in that paragraph, except those associated with submerged arc welds (SAW) or shielded metal arc welds (SMAW). For SAW or SMAW, use paragraph IWB-3640, as modified by the Winter 1985 Addenda.
(vi)
(vii)
(viii)
(A) Grease caps that are accessible must be visually examined to detect grease leakage or grease cap deformations. Grease caps must be removed for this examination when there is evidence of grease cap deformation that indicates deterioration of anchorage hardware.
(B) When evaluation of consecutive surveillances of prestressing forces for the same tendon or tendons in a group indicates a trend of prestress loss such that the tendon force(s) would be less than the minimum design prestress requirements before the next inspection interval, an evaluation must be performed and reported in the Engineering Evaluation Report as prescribed in IWL-3300.
(C) When the elongation corresponding to a specific load (adjusted for effective wires or strands) during retensioning of tendons differs by more than 10 percent from that recorded during the last measurement, an evaluation must be performed to determine whether the difference is related to
(D) The licensee shall report the following conditions, if they occur, in the ISI Summary Report required by IWA-6000:
(
(
(
(E) For Class CC applications, the licensee shall evaluate the acceptability of inaccessible areas when conditions exist in accessible areas that could indicate the presence of or result in degradation to such inaccessible areas. For each inaccessible area identified, the licensee shall provide the following in the ISI Summary Report required by IWA-6000:
(
(
(
(F) Personnel that examine containment concrete surfaces and tendon hardware, wires, or strands must meet the qualification provisions in IWA-2300. The “owner-defined” personnel qualification provisions in IWL-2310(d) are not approved for use.
(ix)
(A) For Class MC applications, the licensee shall evaluate the acceptability of inaccessible areas when conditions exist in accessible areas that could indicate the presence of or result in degradation to such inaccessible areas. For each inaccessible area identified, the licensee shall provide the following in the ISI Summary Report as required by IWA-6000:
(
(
(
(B) When performing remotely the visual examinations required by Subsection IWE, the maximum direct examination distance specified in Table IWA-2210-1 may be extended and the minimum illumination requirements specified in Table IWA-2210-1 may be decreased provided that the conditions or indications for which the visual examination is performed can be detected at the chosen distance and illumination.
(C) The examinations specified in Examination Category E-B, Pressure Retaining Welds, and Examination Category E-F, Pressure Retaining Dissimilar Metal Welds, are optional.
(D) Section 50.55a(b)(2)(ix)(D) may be used as an alternative to the requirements of IWE-2430.
(
(
(
(
(
(E) A general visual examination as required by Subsection IWE must be performed once each period.
(F) VT-1 and VT-3 examinations must be conducted in accordance with IWA-2200. Personnel conducting examinations in accordance with the VT-1 or VT-3 examination method shall be qualified in accordance with IWA-2300. The “owner-defined” personnel qualification provisions in IWE-2330(a) for personnel that conduct VT-1 and VT-3 examinations are not approved for use.
(G) The VT-3 examination method must be used to conduct the examinations in Items E1.12 and E1.20 of Table IWE-2500-1, and the VT-1 examination method must be used to conduct the examination in Item E4.11 of Table IWE-2500-1. An examination of the pressure-retaining bolted connections in Item E1.11 of Table IWE-2500-1 using the VT-3 examination method must be conducted once each interval. The “owner-defined” visual examination provisions in IWE-2310(a) are not approved for use for VT-1 and VT-3 examinations.
(H) Containment bolted connections that are disassembled during the scheduled performance of the examinations in Item E1.11 of Table IWE-2500-1 must be examined using the VT-3 examination method. Flaws or degradation identified during the performance of a VT-3 examination must be examined in accordance with the VT-1 examination method. The criteria in the material specification or IWB-3517.1 must be used to evaluate containment bolting flaws or degradation. As an alternative to performing VT-3 examinations of containment bolted connections that are disassembled during the scheduled performance of Item E1.11, VT-3 examinations of containment bolted connections may be conducted whenever containment bolted connections are disassembled for any reason.
(I) The ultrasonic examination acceptance standard specified in IWE-3511.3 for Class MC pressure-retaining components must also be applied to metallic liners of Class CC pressure-retaining components.
(x)
(xi)
(xii)
(xiii)
(A) When implementing Code Case N-513, the specific safety factors in paragraph 4.0 must be satisfied.
(B) Code Case N-513 may not be applied to:
(
(
(
(
(xiv)
(xv)
(A) When applying Supplements 2, 3, and 10 to Appendix VIII, the following examination coverage criteria requirements must be used:
(
(
(B) The following provisions must be used in addition to the requirements of Supplement 4 to Appendix VIII:
(
(
(C) When applying Supplement 4 to Appendix VIII, the following provisions must be used:
(
(
(
(
(
(
(
(D) The following provisions must be used in addition to the requirements of Supplement 6 to Appendix VIII:
(
(
(
(
(
(
(E) When applying Supplement 6 to Appendix VIII, the following provisions must be used:
(
(
(
(
(
(F) The following provisions may be used for personnel qualification for combined Supplement 4 to Appendix VIII and Supplement 6 to Appendix VIII qualification. Licensees choosing to apply this combined qualification shall apply all of the provisions of Supplements 4 and 6 including the following provisions:
(
(
(
(G) When applying Supplement 4 to Appendix VIII, Supplement 6 to Appendix VIII, or combined Supplement 4 and Supplement 6 qualification, the following additional provisions must be used, and examination coverage must include:
(
(
(
(H) When applying Supplement 5 to Appendix VIII, at least 50 percent of the flaws in the demonstration test set must be cracks and the maximum misorientation shall be demonstrated with cracks. Flaws in nozzles with bore diameters equal to or less than 4 inches may be notches.
(I) When applying Supplement 5, Paragraph (a), to Appendix VIII, the following provision must be used in calculating the number of permissible false calls:
(
(J) When applying the requirements of Supplement 5 to Appendix VIII, qualifications for the nozzle inside radius performed from the outside surface may be performed in accordance with Code Case N-552, “Qualification for Nozzle Inside Radius Section from the Outside Surface,” provided that 10 CFR 50.55a(b)(2)(xv)(I)(
(K) When performing nozzle-to-vessel weld examinations, the following provisions must be used when the requirements contained in Supplement 7 to Appendix VIII are applied for nozzle-to-vessel welds in conjunction with Supplement 4 to Appendix VIII, Supplement 6 to Appendix VIII, or combined Supplement 4 and Supplement 6 qualification.
(
(
(
(
(
(
(
(
(
(
(
(
(L) As a modification to the requirements of Supplement 8, Subparagraph 1.1(c), to Appendix VIII, notches may be located within one diameter of each end of the bolt or stud.
(M) When implementing Supplement 12 to Appendix VIII, only the provisions related to the coordinated implementation of Supplement 3 to Supplement 2 performance demonstrations are to be applied.
(xvi)
(A) Examinations performed from one side of a ferritic vessel weld must be conducted with equipment, procedures, and personnel that have demonstrated proficiency with single side examinations. To demonstrate equivalency to two sided examinations, the demonstration must be performed to the requirements of Appendix VIII as modified by this paragraph and §§ 50.55a(b)(2)(xv) (B) through (G), on specimens containing flaws with non-optimum sound energy reflecting characteristics or flaws similar to those in the vessel being examined.
(B) Examinations performed from one side of a ferritic or stainless steel pipe weld must be conducted with equipment, procedures, and personnel that have demonstrated proficiency with single side examinations. To demonstrate equivalency to two sided examinations, the demonstration must be performed to the requirements of Appendix VIII as modified by this paragraph and § 50.55a(b)(2)(xv)(A).
(xvii)
(xviii)
(B) Paragraph IWA-2316 of the 1998 Edition through the latest edition and addenda incorporated by reference in paragraph (b)(2) of this section, may only be used to qualify personnel that observe for leakage during system leakage and hydrostatic tests conducted in accordance with IWA-5211(a) and (b), 1998 Edition through the latest edition and addenda incorporated by reference in paragraph (b)(2) of this section.
(C) When qualifying visual examination personnel for VT-3 visual examinations under paragraph IWA-2317 of the 1998 Edition through the latest edition and addenda incorporated by reference in paragraph (b)(2) of this section, the proficiency of the training must be demonstrated by administering an initial qualification examination and administering subsequent examinations on a 3-year interval.
(xix)
(xx)
(xxi)
(B) The provisions of Table IWB-2500-1, Examination Category B-G-2, Item B7.80, that are in the 1995 Edition are applicable only to reused bolting when using the 1997 Addenda through the latest edition and addenda incorporated by reference in paragraph (b)(2) of this section.
(C) The provisions of Table IWB-2500-1, Examination Category B-K, Item B10.10, of the 1995 Addenda must be applied when using the 1997 Addenda through the latest edition and addenda incorporated by reference in paragraph (b)(2) of this section.
(3) As used in this section, references to the OM Code refer to the ASME Code for Operation and Maintenance of Nuclear Power Plants, and include the 1995 Edition through the 2000 Addenda subject to the following limitations and modifications:
(i)
(ii)
(iii)
(A) The adequacy of the diagnostic test interval for each valve must be evaluated and adjusted as necessary but not later than 5 years or three refueling outages (whichever is longer) from initial implementation of ASME Code Case OMN-1.
(B) When extending exercise test intervals for high risk motor-operated valves beyond a quarterly frequency, licensees shall ensure that the potential increase in core damage frequency and risk associated with the extension is small and consistent with the intent of the Commission's Safety Goal Policy Statement.
(iv)
(A) Valve opening and closing functions must be demonstrated when flow testing or examination methods (nonintrusive, or disassembly and inspection) are used;
(B) The initial interval for tests and associated examinations may not exceed two fuel cycles or 3 years, whichever is longer; any extension of this interval may not exceed one fuel cycle per extension with the maximum interval not to exceed 10 years; trending and evaluation of existing data must be used to reduce or extend the time interval between tests.
(C) If the Appendix II condition monitoring program is discontinued, then the requirements of ISTC 4.5.1 through 4.5.4 must be implemented.
(D) The provisions of ISTC-3510, ISTC-3520, and ISTC-3540 in addition to ISTC-5221 must be implemented if the Appendix II condition monitoring program is discontinued.
(v)
(vi)
(c)
See footnotes at end of section.
(2) Components which are connected to the reactor coolant system and are part of the reactor coolant pressure boundary as defined in § 50.2 need not meet the requirements of paragraph (c)(1) of this section,
(i) In the event of postulated failure of the component during normal reactor operation, the reactor can be shut down and cooled down in an orderly manner, assuming makeup is provided by the reactor coolant makeup system; or
(ii) The component is or can be isolated from the reactor coolant system by two valves in series (both closed, both open, or one closed and the other open). Each open valve must be capable of automatic actuation and, assuming the other valve is open, its closure time must be such that, in the event of postulated failure of the component during normal reactor operation, each valve remains operable and the reactor can be shut down and cooled down in an orderly manner, assuming makeup is provided by the reactor coolant makeup system only.
(3) The Code Edition, Addenda, and optional Code Cases
(4) For a nuclear power plant whose construction permit was issued prior to May 14, 1984 the applicable Code Edition and Addenda for a component of the reactor coolant pressure boundary continue to be that Code Edition and Addenda that were required by Commission regulations for such component at the time of issuance of the construction permit.
(d)
(2) The Code Edition, Addenda, and optional Code Cases
(e)
(2) The Code Edition, Addenda, and optional Code Cases
(f)
(1) For a boiling or pressurized water-cooled nuclear power facility whose construction permit was issued prior to January 1, 1971, pumps and valves must meet the test requirements of paragraphs (f)(4) and (f)(5) of this section to the extent practical. Pumps and valves which are part of the reactor coolant pressure boundary must meet the requirements applicable to components which are classified as ASME Code Class 1. Other pumps and valves that perform a function to shut down the reactor or maintain the reactor in a safe shutdown condition, mitigate the consequences of an accident, or provide overpressure protection for safety-related systems (in meeting the requirements of the 1986 Edition, or later, of the Boiler and Pressure Vessel or OM Code) must meet the test requirements applicable to components which are classified as ASME Code Class 2 or Class 3.
(2) For a boiling or pressurized water-cooled nuclear power facility whose construction permit was issued on or after January 1, 1971, but before July 1, 1974, pumps and valves which are classified as ASME Code Class 1 and Class 2 must be designed and be provided with access to enable the performance of inservice tests for operational readiness set forth in editions of Section XI of the ASME Boiler and Pressure Vessel Code and Addenda
(3) For a boiling or pressurized water-cooled nuclear power facility whose construction permit was issued on or after July 1, 1974:
(i)-(ii) [Reserved]
(iii)(A) Pumps and valves, in facilities whose construction permit was issued before November 22, 1999, which are classified as ASME Code Class 1 must be designed and be provided with access to enable the performance of inservice testing of the pumps and valves for assessing operational readiness set forth in Section XI of editions of the ASME Boiler and Pressure Vessel Code and Addenda
(B) Pumps and valves, in facilities whose construction permit is issued on or after November 22, 1999, which are classified as ASME Code Class 1 must be designed and be provided with access to enable the performance of inservice testing of the pumps and valves for assessing operational readiness set forth in editions and addenda of the ASME OM Code referenced in paragraph (b)(3) of this section at the time the construction permit is issued.
(iv)(A) Pumps and valves, in facilities whose construction permit was issued before November 22, 1999, which are classified as ASME Code Class 2 and Class 3 must be designed and be provided with access to enable the performance of inservice testing of the pumps and valves for assessing operational readiness set forth in Section XI of editions of the ASME Boiler and Pressure Vessel Code and Addenda
(B) Pumps and valves, in facilities whose construction permit is issued on or after November 22, 1999, which are classified as ASME Code Class 2 and 3 must be designed and be provided with access to enable the performance of inservice testing of the pumps and valves for assessing operational readiness set forth in editions and addenda of the ASME OM Code referenced in paragraph (b)(3) of this section at the time the construction permit is issued.
(v) All pumps and valves may meet the test requirements set forth in subsequent editions of codes and addenda or portions thereof which are incorporated by reference in paragraph (b) of this section, subject to the limitations
(4) Throughout the service life of a boiling or pressurized water-cooled nuclear power facility, pumps and valves which are classified as ASME Code Class 1, Class 2 and Class 3 must meet the inservice test requirements, except design and access provisions, set forth in the ASME OM Code and addenda that become effective subsequent to editions and addenda specified in paragraphs (f)(2) and (f)(3) of this section and that are incorporated by reference in paragraph (b) of this section, to the extent practical within the limitations of design, geometry and materials of construction of the components.
(i) Inservice tests to verify operational readiness of pumps and valves, whose function is required for safety, conducted during the initial 120-month interval must comply with the requirements in the latest edition and addenda of the Code incorporated by reference in paragraph (b) of this section on the date 12 months prior to the date of issuance of the operating license, subject to the limitations and modifications listed in paragraph (b) of this section.
(ii) Inservice tests to verify operational readiness of pumps and valves, whose function is required for safety, conducted during successive 120-month intervals must comply with the requirements of the latest edition and addenda of the Code incorporated by reference in paragraph (b) of this section 12 months prior to the start of the 120-month interval, subject to the limitations and modifications listed in paragraph (b) of this section.
(iii) [Reserved]
(iv) Inservice tests of pumps and valves may meet the requirements set forth in subsequent editions and addenda that are incorporated by reference in paragraph (b) of this section, subject to the limitations and modifications listed in paragraph (b) of this section, and subject to Commission approval. Portions of editions or addenda may be used provided that all related requirements of the respective editions or addenda are met.
(5)(i) The inservice test program for a boiling or pressurized water-cooled nuclear power facility must be revised by the licensee, as necessary, to meet the requirements of paragraph (f)(4) of this section.
(ii) If a revised inservice test program for a facility conflicts with the technical specification for the facility, the licensee shall apply to the Commission for amendment of the technical specifications to conform the technical specification to the revised program. The licensee shall submit this application, as specified in § 50.4, at least 6 months before the start of the period during which the provisions become applicable, as determined by paragraph (f)(4) of this section.
(iii) If the licensee has determined that conformance with certain code requirements is impractical for its facility, the licensee shall notify the Commission and submit, as specified in § 50.4, information to support the determination.
(iv) Where a pump or valve test requirement by the code or addenda is determined to be impractical by the licensee and is not included in the revised inservice test program as permitted by paragraph (f)(4) of this section, the basis for this determination must be demonstrated to the satisfaction of the Commission not later than 12 months after the expiration of the initial 120-month period of operation from start of facility commercial operation and each subsequent 120-month period of operation during which the test is determined to be impractical.
(6)(i) The Commission will evaluate determinations under paragraph (f)(5) of this section that code requirements are impractical. The Commission may grant relief and may impose such alternative requirements as it determines is authorized by law and will not endanger life or property or the common defense and security and is otherwise in the public interest giving due consideration to the burden upon the licensee that could result if the requirements were imposed on the facility.
(ii) The Commission may require the licensee to follow an augmented inservice test program for pumps and valves for which the Commission deems that added assurance of operational readiness is necessary.
(g)
(1) For a boiling or pressurized water-cooled nuclear power facility whose construction permit was issued before January 1, 1971, components (including supports) must meet the requirements of paragraphs (g)(4) and (g)(5) of this section to the extent practical. Components which are part of the reactor coolant pressure boundary and their supports must meet the requirements applicable to components which are classified as ASME Code Class 1. Other safety-related pressure vessels, piping, pumps and valves, and their supports must meet the requirements applicable to components which are classified as ASME Code Class 2 or Class 3.
(2) For a boiling or pressurized water-cooled nuclear power facility whose construction permit was issued on or after January 1, 1971, but before July 1, 1974, components (including supports) which are classified as ASME Code Class 1 and Class 2 must be designed and be provided with access to enable the performance of inservice examination of such components (including supports) and must meet the preservice examination requirements set forth in editions of section XI of the ASME Boiler and Pressure Vessel Code and Addenda
(3) For a boiling or pressurized water-cooled nuclear power facility whose construction permit was issued on or after July 1, 1974:
(i) Components (including supports) which are classified as ASME Code Class 1 must be designed and be provided with access to enable the performance of inservice examination of such components and must meet the preservice examination requirements set forth in Section XI of editions of the ASME Boiler and Pressure Vessel Code and Addenda
(ii) Components which are classified as ASME Code Class 2 and Class 3 and supports for components which are classified as ASME Code Class 1, Class 2, and Class 3 must be designed and be provided with access to enable the performance of inservice examination of such components and must meet the preservice examination requirements set forth in section XI of editions of the ASME Boiler and Pressure Vessel Code and Addenda
(iii)-(iv) [Reserved]
(v) All components (including supports) may meet the requirements set forth in subsequent editions of codes and addenda or portions thereof which are incorporated by reference in paragraph (b) of this section, subject to the limitations and modifications listed therein.
(4) Throughout the service life of a boiling or pressurized water-cooled nuclear power facility, components (including supports) which are classified as ASME Code Class 1, Class 2 and Class 3 must meet the requirements, except design and access provisions and preservice examination requirements, set forth in Section XI of editions of the ASME Boiler and Pressure Vessel Code and Addenda that become effective subsequent to editions specified in paragraphs (g)(2) and (g)(3) of this section and that are incorporated by reference in paragraph (b) of this section, to the extent practical within the limitations of design, geometry and materials of construction of the components. Components which are classified as Class MC pressure retaining components and their integral attachments, and components which are classified as Class CC pressure retaining components and their integral attachments must meet the requirements, except design and access provisions and preservice examination requirements, set forth in Section XI of the ASME Boiler and Pressure Vessel Code and Addenda that are incorporated by reference in paragraph (b) of this section, subject to the limitation listed in paragraph (b)(2)(vi) of this section and the modifications listed in paragraphs (b)(2)(viii) and (b)(2)(ix) of this section,
(i) Inservice examinations of components and system pressure tests conducted during the initial 120-month inspection interval must comply with the requirements in the latest edition and addenda of the Code incorporated by reference in paragraph (b) of this section on the date 12 months prior to the date of issuance of the operating license, subject to the limitations and modifications listed in paragraph (b) of this section.
(ii) Inservice examination of components and system pressure tests conducted during successive 120-month inspection intervals must comply with the requirements of the latest edition and addenda of the Code incorporated by reference in paragraph (b) of this section 12 months prior to the start of the 120-month inspection interval, subject to the limitations and modifications listed in paragraph (b) of this section.
(iii) Licensees may, but are not required to, perform the surface examinations of High Pressure Safety Injection Systems specified in Table IWB-2500-1, Examination Category B-J, Item Numbers B9.20, B9.21, and B9.22.
(iv) Inservice examination of components and system pressure tests may meet the requirements set forth in subsequent editions and addenda that are incorporated by reference in paragraph (b) of this section, subject to the limitations and modifications listed in paragraph (b) of this section, and subject to Commission approval. Portions of editions or addenda may be used provided that all related requirements of the respective editions or addenda are met.
(v) For a boiling or pressurized water-cooled nuclear power facility whose construction permit was issued after January 1, 1956:
(A) Metal containment pressure retaining components and their integral attachments must meet the inservice inspection, repair, and replacement requirements applicable to components which are classified as ASME Code Class MC;
(B) Metallic shell and penetration liners which are pressure retaining components and their integral attachments in concrete containments must meet the inservice inspection, repair, and replacement requirements applicable to components which are classified as ASME Code Class MC; and
(C) Concrete containment pressure retaining components and their integral attachments, and the post-tensioning systems of concrete containments must meet the inservice inspection, repair, and replacement requirements applicable to components which are classified as ASME Code Class CC.
(5)(i) The inservice inspection program for a boiling or pressurized water-cooled nuclear power facility must be revised by the licensee, as necessary, to meet the requirements of paragraph (g)(4) of this section.
See footnotes at end of section.
(ii) If a revised inservice inspection program for a facility conflicts with the technical specification for the facility, the licensee shall apply to the Commission for amendment of the technical specifications to conform the technical specification to the revised program. The licensee shall submit this application, as specified in § 50.4, at least six months before the start of the period during which the provisions become applicable, as determined by paragraph (g)(4) of this section.
(iii) If the licensee has determined that conformance with certain code requirements is impractical for its facility, the licensee shall notify the Commission and submit, as specified in § 50.4, information to support the determinations.
(iv) Where an examination requirement by the code or addenda is determined to be impractical by the licensee and is not included in the revised inservice inspection program as permitted by paragraph (g)(4) of this section, the basis for this determination must be demonstrated to the satisfaction of the Commission not later than 12 months after the expiration of the initial 120-month period of operation from start of facility commercial operation and each subsequent 120-month period of operation during which the
(6)(i) The Commission will evaluate determinations under paragraph (g)(5) of this section that code requirements are impractical. The Commission may grant such relief and may impose such alternative requirements as it determines is authorized by law and will not endanger life or property or the common defense and security and is otherwise in the public interest giving due consideration to the burden upon the licensee that could result if the requirements were imposed on the facility.
(ii) The Commission may require the licensee to follow an augmented inservice inspection program for systems and components for which the Commission deems that added assurance of structural reliability is necessary.
(A) Augmented examination of reactor vessel.
(
(
(
(
(
(
(
(
(
(
(
(B) Licensees do not have to submit to the NRC staff for approval of their containment inservice inspection programs which were developed to satisfy the requirements of Subsection IWE and Subsection IWL with specified modifications and limitations. The program elements and the required documentation must be maintained on site for audit.
(C)
(
(h) Protection and safety systems. (1) IEEE Std. 603-1991, including the correction sheet dated January 30, 1995, which is referenced in paragraphs (h)(2) and (h)(3) of this section, is approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. Copies of IEEE Std. 603-1991 may be purchased from the Institute of Electrical and Electronics Engineers Service Center, 445 Hoes Lane, Piscataway, NJ 08855. The standard is also available for inspection at the NRC Library, 11545 Rockville Pike, Rockville, Md; and at the Office of the Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC IEEE Std. 279, which is referenced in paragraph (h)(2) of this section, was approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. Copies of IEEE Std. 279 are also available as indicated for IEEE Std. 603-1991.
(2) Protection systems. For nuclear power plants with construction permits issued after January 1, 1971, but before May 13, 1999, protection systems must meet the requirements stated in either IEEE Std. 279, “Criteria for Protection Systems for Nuclear Power Generating Stations,” or in IEEE Std. 603-1991, “Criteria for Safety Systems for Nuclear Power Generating Stations,” and the correction sheet dated January 30, 1995. For nuclear power plants with construction permits issued before January 1, 1971, protection systems must be consistent with their licensing basis or may meet the requirements of IEEE Std. 603-1991 and the correction sheet dated January 30, 1995.
(3) Safety systems. Applications filed on or after May 13, 1999 for preliminary and final design approvals (10 CFR Part 52, Appendix O), design certifications,
Footnotes to § 50.55a:
For
Upon completion of the construction or alteration of a facility, in compliance with the terms and conditions of the construction permit and subject to any necessary testing of the facility for health or safety purposes, the Commission will, in the absence of good cause shown to the contrary issue a license of the class for which the construction permit was issued or an appropriate amendment of the license, as the case may be.
(a)Pursuant to § 50.56, an operating license may be issued by the Commission, up to the full term authorized by § 50.51, upon finding that:
(1) Construction of the facility has been substantially completed, in conformity with the construction permit and the application as amended, the provisions of the Act, and the rules and regulations of the Commission; and
(2) The facility will operate in conformity with the application as amended, the provisions of the Act, and the rules and regulations of the Commission; and
(3) There is reasonable assurance (i) that the activities authorized by the operating license can be conducted without endangering the health and safety of the public, and (ii) that such activities will be conducted in compliance with the regulations in this chapter; and
(4) The applicant is technically and financially qualified to engage in the activities authorized by the operating license in accordance with the regulations in this chapter. However, no finding of financial qualification is necessary for an electric utility applicant
(5) The applicable provisions of part 140 of this chapter have been satisfied; and
(6) The issuance of the license will not be inimical to the common defense and security or to the health and safety of the public.
(b) Each operating license will include appropriate provisions with respect to any uncompleted items of construction and such limitations or conditions as are required to assure that operation during the period of the completion of such items will not endanger public health and safety.
(c) An applicant may, in a case where a hearing is held in connection with a pending proceeding under this section make a motion in writing, pursuant to this paragraph (c), for an operating license authorizing low-power testing (operation at not more than 1 percent of full power for the purpose of testing the facility), and further operations short of full power operation. Action on such a motion by the presiding officer shall be taken with due regard to the rights of the parties to the proceeding, including the right of any party to be heard to the extent that his contentions are relevant to the activity to be authorized. Prior to taking any action on such a motion which any party opposes, the presiding officer shall make findings on the matters specified in paragraph (a) of this section as to which there is a controversy, in the form of an initial decision with respect to the contested activity sought to be authorized. The Director of Nuclear Reactor Regulation will make findings on all other matters specified in paragraph (a) of this section. If no party opposes the motion, the presiding officer will issue an order pursuant to § 2.730(e) of this chapter, authorizing the Director of Nuclear Reactor Regulation to make appropriate findings on the matters specified in paragraph (a) of this section and to issue a license for the requested operation.
(a) Each application for a construction permit or an operating license for a facility which is of a type described in § 50.21(b) or § 50.22, or for a testing facility, shall be referred to the Advisory Committee on Reactor Safeguards for a review and report. An application for an amendment to such a construction permit or operating license may be referred to the Advisory Committee on Reactor Safeguards for review and report. Any report shall be made part of the record of the application and available to the public, except to the extent that security classification prevents disclosure.
(b)(1) The Commission will hold a hearing after at least 30-days’ notice and publication once in the
(2) When a construction permit has been issued for such a facility following the holding of a public hearing, and an application is made for an operating license or for an amendment to a construction permit or operating license, the Commission may hold a hearing after at least 30-days’ notice and publication once in the
(3) If the Commission finds, in an emergency situation, as defined in § 50.91, that no significant hazards consideration is presented by an application for an amendment to an operating license, it may dispense with public notice and comment and may issue the amendment. If the Commission finds that exigent circumstances exist, as described in § 50.91, it may reduce the period provided for public notice and comment.
(4) Both in an emergency situation and in the case of exigent circumstances, the Commission will provide 30 days notice of opportunity for a hearing, though this notice may be published after issuance of the amendment if the Commission determines that no significant hazards consideration is involved.
(5) The Commission will use the standards in § 50.92 to determine whether a significant hazards consideration is presented by an amendment to an operating license for a facility of the type described in § 50.21(b) or § 50.22, or which is a testing facility, and may make the amendment immediately effective, notwithstanding the pendency before it of a request for a hearing from any person, in advance of the holding and completion of any required hearing, where it has determined that no significant hazards consideration is involved.
(6) No petition or other request for review of or hearing on the staff's significant hazards consideration determination will be entertained by the Commission. The staff's determination is final, subject only to the Commission's discretion, on its own initiative, to review the determination.
(a) Definitions for the purposes of this section:
(1)
(2)
(i) Changing any of the elements of the method described in the FSAR (as updated) unless the results of the analysis are conservative or essentially the same; or
(ii) Changing from a method described in the FSAR to another method unless that method has been approved by NRC for the intended application.
(3)
(i) The structures, systems, and components (SSC) that are described in the final safety analysis report (FSAR) (as updated),
(ii) The design and performance requirements for such SSCs described in the FSAR (as updated), and
(iii) The evaluations or methods of evaluation included in the FSAR (as updated) for such SSCs which demonstrate that their intended function(s) will be accomplished.
(4)
(5)
(6)
(i) Outside the reference bounds of the design bases as described in the final safety analysis report (as updated) or
(ii) Inconsistent with the analyses or descriptions in the final safety analysis report (as updated).
(b) Applicability. This section applies to each holder of a license authorizing operation of a production or utilization facility, including the holder of a license authorizing operation of a nuclear power reactor that has submitted the certification of permanent cessation of operations required under § 50.82(a)(1) or a reactor licensee whose license has been amended to allow possession of nuclear fuel, but not operation of the facility.
(c)(1) A licensee may make changes in the facility as described in the final
(i) A change to the technical specifications incorporated in the license is not required, and
(ii) The change, test, or experiment does not meet any of the criteria in paragraph (c)(2) of this section.
(2) A licensee shall obtain a license amendment pursuant to § 50.90 prior to implementing a proposed change, test, or experiment if the change, test, or experiment would:
(i) Result in more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the final safety analysis report (as updated);
(ii) Result in more than a minimal increase in the likelihood of occurrence of a malfunction of a structure, system, or component (SSC) important to safety previously evaluated in the final safety analysis report (as updated);
(iii) Result in more than a minimal increase in the consequences of an accident previously evaluated in the final safety analysis report (as updated);
(iv) Result in more than a minimal increase in the consequences of a malfunction of an SSC important to safety previously evaluated in the final safety analysis report (as updated);
(v) Create a possibility for an accident of a different type than any previously evaluated in the final safety analysis report (as updated);
(vi) Create a possibility for a malfunction of an SSC important to safety with a different result than any previously evaluated in the final safety analysis report (as updated);
(vii) Result in a design basis limit for a fission product barrier as described in the FSAR (as updated) being exceeded or altered; or
(viii) Result in a departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses.
(3) In implementing this paragraph, the FSAR (as updated) is considered to include FSAR changes resulting from evaluations performed pursuant to this section and analyses performed pursuant to § 50.90 since submittal of the last update of the final safety analysis report pursuant to § 50.71 of this part.
(4) The provisions in this section do not apply to changes to the facility or procedures when the applicable regulations establish more specific criteria for accomplishing such changes.
(d)(1) The licensee shall maintain records of changes in the facility, of changes in procedures, and of tests and experiments made pursuant to paragraph (c) of this section. These records must include a written evaluation which provides the bases for the determination that the change, test, or experiment does not require a license amendment pursuant to paragraph (c)(2) of this section.
(2) The licensee shall submit, as specified in § 50.4, a report containing a brief description of any changes, tests, and experiments, including a summary of the evaluation of each. A report must be submitted at intervals not to exceed 24 months.
(3) The records of changes in the facility must be maintained until the termination of a license issued pursuant to this part or the termination of a license issued pursuant to 10 CFR part 54, whichever is later. Records of changes in procedures and records of tests and experiments must be maintained for a period of 5 years.
(a) Except as provided in paragraph (b) of this section, all light-water nuclear power reactors, other than reactor facilities for which the certifications required under § 50.82(a)(1) have been submitted, must meet the fracture toughness and material surveillance program requirements for the reactor coolant pressure boundary set forth in appendices G and H to this part.
(b) Proposed alternatives to the described requirements in Appendices G and H of this part or portions thereof
(a)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(b)
(2) The pressurized thermal shock (PTS) screening criterion is 270 °F for plates, forgings, and axial weld materials, and 300 °F for circumferential weld materials. For the purpose of comparison with this criterion, the value of RT
(3) For each pressurized water nuclear power reactor for which the value of RT
(4) For each pressurized water nuclear power reactor for which the analysis required by paragraph (b)(3) of this section indicates that no reasonably practicable flux reduction program will prevent RT
(5) After consideration of the licensee's analyses, including effects of proposed corrective actions, if any, submitted in accordance with paragraphs (b)(3) and (b)(4) of this section, the Director, Office of Nuclear Reactor Regulation, may, on a case-by-case basis, approve operation of the facility with RT
(6) If the Director, Office of Nuclear Reactor Regulation, concludes, pursuant to paragraph (b)(5) of this section, that operation of the facility with RT
(7) If the limiting RT
(c)
(1) Equation 1 must be used to calculate values of RT
(i) If a measured value of RT
(ii) For generic values of weld metal, the following generic mean values must be used unless justification for different values is provided: 0 °F for welds made with Linde 80 flux, and −56 °F for welds made with Linde 0091, 1092 and 124 and ARCOS B-5 weld fluxes.
(iii)
(A) In Equation 2, σ
(B) In Equation 2, σ
(iv) ΔRT
(A)
(B)
(v) Equation 4 must be used for determining RT
(2) To verify that RT
(i) Results from the plant-specific surveillance program must be integrated into the RT
(A) The materials in the surveillance capsules must be those which are the controlling materials with regard to radiation embrittlement.
(B) Scatter in the plots of Charpy energy versus temperature for the irradiated and unirradiated conditions must be small enough to permit the determination of the 30-foot-pound temperature unambiguously.
(C) Where there are two or more sets of surveillance data from one reactor, the scatter of ΔRT
(D) The irradiation temperature of the Charpy specimens in the capsule must equal the vessel wall temperature at the cladding/base metal interface within ±25 °F.
(E) The surveillance data for the correlation monitor material in the capsule, if present, must fall within the scatter band of the data base for the material.
(ii)(A) Surveillance data deemed credible according to the criteria of paragraph (c)(2)(i) of this section must be used to determine a material-specific value of CF for use in Equation 3. A material-specific value of CF is determined from Equation 5.
(B) In Equation 5, “n” is the number of surveillance data points, “A
(iii) For cases in which the results from a credible plant-specific surveillance program are used, the value of σ
(iv) The use of results from the plant-specific surveillance program may result in an RT
(3) Any information that is believed to improve the accuracy of the RT
(a)
(b)
(c)
(2) Each pressurized water reactor manufactured by Combustion Engineering or by Babcock and Wilcox must have a diverse scram system from the sensor output to interruption of power to the control rods. This scram system must be designed to perform its function in a reliable manner and be independent from the existing reactor trip system (from sensor output to interruption of power to the control rods).
(3) Each boiling water reactor must have an alternate rod injection (ARI) system that is diverse (from the reactor trip system) from sensor output to the final actuation device. The ARI system must have redundant scram air header exhaust valves. The ARI must be designed to perform its function in a reliable manner and be independent (from the existing reactor trip system) from sensor output to the final actuation device.
(4) Each boiling water reactor must have a standby liquid control system (SLCS) with the capability of injecting into the reactor pressure vessel a borated water solution at such a flow rate, level of boron concentration and boron-10 isotope enrichment, and accounting for reactor pressure vessel volume, that the resulting reactivity control is at least equivalent to that resulting from injection of 86 gallons per minute of 13 weight percent sodium pentaborate decahydrate solution at the natural boron-10 isotope abundance into a 251-inch inside diameter reactor pressure vessel for a given core design. The SLCS and its injection location must be designed to perform its function in a reliable manner. The SLCS initiation must be automatic and must be designed to perform its function in a reliable manner for plants granted a construction permit after July 26, 1984, and for plants granted a construction permit prior to July 26, 1984, that have already been designed and built to include this feature.
(5) Each boiling water reactor must have equipment to trip the reactor coolant recirculating pumps automatically under conditions indicative of an ATWS. This equipment must be designed to perform its function in a reliable manner.
(6) Information sufficient to demonstrate to the Commission the adequacy of items in paragraphs (c)(1) through (c)(5) of this section shall be submitted to the Commission as specified in § 50.4.
(d)
(a)
(i) The redundancy of the onsite emergency ac power sources;
(ii) The reliability of the onsite emergency ac power sources;
(iii) The expected frequency of loss of offsite power; and
(iv) The probable time needed to restore offsite power.
(2) The reactor core and associated coolant, control, and protection systems, including station batteries and any other necessary support systems, must provide sufficient capacity and capability to ensure that the core is cooled and appropriate containment integrity is maintained in the event of a station blackout for the specified duration. The capability for coping with a station blackout of specified duration shall be determined by an appropriate coping analysis. Licensees are expected to have the baseline assumptions, analyses, and related information used in their coping evaluations available for NRC review.
(b)
(c)
(i) A proposed station blackout duration to be used in determining compliance with paragraph (a) of this section, including a justification for the selection based on the four factors identified in paragraph (a) of this section;
(ii) A description of the procedures that will be implemented for station blackout events for the duration determined in paragraph (c)(1)(i) of this section and for recovery therefrom; and
(iii) A list of modifications to equipment and associated procedures, if any, necessary to meet the requirements of paragraph (a) of this section, for the specified station blackout duration determined in paragraph (c)(1)(i) of this section, and a proposed schedule for implementing the stated modifications.
(2)
(3)
(4)
(a)
(b)
(2) Unless the Commission has determined, based on a request submitted in accordance with paragraph (c)(1) of this section, that the non-power reactor has a unique purpose, each licensee authorized to possess and use HEU fuel in connection with the reactor's operation shall:
(i) Not initiate acquisition of additional HEU fuel, if low enriched uranium (LEU) fuel acceptable to the Commission for that reactor is available when it proposes that acquisition; and
(ii) Replace all HEU fuel in its possession with available LEU fuel acceptable to the Commission for that reactor, in accordance with a schedule determined pursuant to paragraph (c)(2) of this section.
(3) If not required by paragraphs (b) (1) and (2) of this section to use LEU fuel, the applicant or licensee must use HEU fuel of enrichment as close to 20% as is available and acceptable to the Commisson.
(c)
(2) (i) By March 27, 1987 and at 12-month intervals thereafter, each licensee of a non-power reactor authorized to possess and use HEU fuel shall develop and submit to the Director of the Office of Nuclear Reactor Regulation a written proposal for meeting the requirements of paragraph (b) (2) or (3) of this section. The licensee shall include in the proposal a certification that Federal Government funding for conversion is available through the Department of Energy (DOE) or other appropriate Federal Agency. The licensee shall also include in the proposal a schedule for conversion, based upon availability of replacement fuel acceptable to the Commisson for that reactor and upon consideration of other factors such as the availability of shipping casks, implementation of arrangements for the available financial support, and reactor usage.
(ii) If Federal Government funding for conversion cannot be certified, the proposal's contents may be limited to a statement of this fact. If a statement of non-availability of Federal Government funding for conversion is submitted by a licensee, then it shall be required to resubmit a proposal for meeting the requirements of paragraph (b) (2) or (3) of this section at 12-month intervals.
(iii) The proposal shall include, to the extent required to effect the conversion, all necessary changes in the license, facility, or procedures. Supporting safety analyses should be provided so as to meet the schedule established for conversion. As long as Federal Government funding for conversion is not available, the resubmittal may be a reiteration of the original proposal. The Director of the Office of Nuclear Reactor Regulation shall review the proposal and confirm the status of Federal Government funding for conversion and, if a schedule for conversion has been submitted by the licensee, will then determine a final schedule.
(3) After review of the safety analysis required by paragraph (c)(2), the Director of the Office of Nuclear Reactor Regulation will issue an appropriate enforcement order directing both the conversion and, to the extent consistent with protection of the public health and safety, any necessary changes to the license, facility, or procedures.
The requirements of this section are applicable during all conditions of plant operation, including normal shutdown operations.
(a)(1) Each holder of a license to operate a nuclear power plant under §§ 50.21(b) or 50.22 shall monitor the performance or condition of structures, systems, or components, against licensee-established goals, in a manner
(2) Monitoring as specified in paragraph (a)(1) of this section is not required where it has been demonstrated that the performance or condition of a structure, system, or component is being effectively controlled through the performance of appropriate preventive maintenance, such that the structure, system, or component remains capable of performing its intended function.
(3) Performance and condition monitoring activities and associated goals and preventive maintenance activities shall be evaluated at least every refueling cycle provided the interval between evaluations does not exceed 24 months. The evaluations shall take into account, where practical, industry-wide operating experience. Adjustments shall be made where necessary to ensure that the objective of preventing failures of structures, systems, and components through maintenance is appropriately balanced against the objective of minimizing unavailability of structures, systems, and components due to monitoring or preventive maintenance.
(4) Before performing maintenance activities (including but not limited to surveillance, post-maintenance testing, and corrective and preventive maintenance), the licensee shall assess and manage the increase in risk that may result from the proposed maintenance activities. The scope of the assessment may be limited to structures, systems, and components that a risk-informed evaluation process has shown to be significant to public health and safety.
(b) The scope of the monitoring program specified in paragraph (a)(1) of this section shall include safety related and nonsafety related structures, systems, and components, as follows:
(1) Safety-related structures, systems and components that are relied upon to remain functional during and following design basis events to ensure the integrity of the reactor coolant pressure boundary, the capability to shut down the reactor and maintain it in a safe shutdown condition, or the capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposure comparable to the guidelines in § 50.34(a)(1), § 50.67(b)(2), or § 100.11 of this chapter, as applicable.
(2) Nonsafety related structures, systems, or components:
(i) That are relied upon to mitigate accidents or transients or are used in plant emergency operating procedures (EOPs); or
(ii) Whose failure could prevent safety-related structures, systems, and components from fulfilling their safety-related function; or
(iii) Whose failure could cause a reactor scram or actuation of a safety-related system.
(c) The requirements of this section shall be implemented by each licensee no later than July 10, 1996.
See 64 FR 38551, July 19, 1999, for effectiveness of § 50.65 (a)(3) and (a)(4).
(a) For those light water nuclear power reactors where neutron radiation has reduced the fracture toughness of the reactor vessel materials, a thermal annealing may be applied to
(1) Submitting the Thermal Annealing Report required by paragraph (b) of this section;
(2) The NRC makes available the results of its evaluation of the Thermal Annealing Report at the NRC Web site,
(3) The requirements of paragraph (f)(1) of this section have been satisfied.
(b)
(1)
(i) A detailed description of the pressure vessel and all structures and components that are expected to experience significant thermal or stress effects during the thermal annealing operation;
(ii) An evaluation of the effects of mechanical and thermal stresses and temperatures on the vessel, containment, biological shield, attached piping and appurtenances, and adjacent equipment and components to demonstrate that operability of the reactor will not be detrimentally affected. This evaluation must include:
(A) Detailed thermal and structural analyses to establish the time and temperature profile of the annealing operation. These analyses must include heatup and cooldown rates, and must demonstrate that localized temperatures, thermal stress gradients, and subsequent residual stresses will not result in unacceptable dimensional changes or distortions in the vessel, attached piping and appurtenances, and that the thermal annealing cycle will not result in unacceptable degradation of the fatigue life of these components.
(B) The effects of localized high temperatures on degradation of the concrete adjacent to the vessel and changes in thermal and mechanical properties, if any, of the reactor vessel insulation, and on detrimental effects, if any, on containment and the biological shield. If the design temperature limitations for the adjacent concrete structure are to be exceeded during the thermal annealing operation, an acceptable maximum temperature for the concrete must be established for the annealing operation using appropriate test data.
(iii) The methods, including heat source, instrumentation and procedures proposed for performing the thermal annealing. This shall include any special precautions necessary to minimize occupational exposure, in accordance with the As Low As Reasonably Achievable (ALARA) principle and the provisions of § 20.1206.
(iv) The proposed thermal annealing operating parameters, including bounding conditions for temperatures and times, and heatup and cooldown schedules.
(A) The thermal annealing time and temperature parameters selected must be based on projecting sufficient recovery of fracture toughness, using the procedures of paragraph (e) of this section, to satisfy the requirements of § 50.60 and § 50.61 for the proposed period of operation addressed in the application.
(B) The time and temperature parameters evaluated as part of the thermal annealing operating plan, and supported by the evaluation results of paragraph (b)(1)(ii) of this section, represent the bounding times and temperatures for the thermal annealing operation. If these bounding conditions
(2)
(3)
(i)
(B) If the percent recovery is determined from testing surveillance specimens or from testing materials removed from the reactor vessel, then it shall be demonstrated that the proposed thermal annealing parameters used in the test program are equal to or bounded by those used in the vessel annealing operation.
(C) If generic computational methods are used, appropriate justification must be submitted as a part of the application.
(ii)
(B) The post-anneal reembrittlement trend of both RT
(4)
(c)
(2) If the thermal annealing was completed but the annealing was not performed in accordance with the Thermal Annealing Operating Plan and the Requalification Inspection and Test Program, the licensee shall submit a summary of lack of compliance with the Thermal Annealing Operating Plan and the Requalification Inspection and Test Program and a justification for subsequent operation to the Director, Office of Nuclear Reactor Regulation. Any changes to the facility as described in the final safety analysis report (as updated) which are attributable to the noncompliances and which require a license amendment pursuant to § 50.59(c)(2) and any changes to the Technical Specifications shall also be identified.
(i) If no changes requiring a license amendment pursuant to § 50.59(c)(2) or changes to Technical Specifications are identified, the licensee may restart its reactor after the requirements of paragraph (f)(2) of this section have been met.
(ii) If any changes requiring a license amendment pursuant to § 50.59(c)(2) or changes to the Technical Specifications are identified, the licensee may not restart its reactor until approval is obtained from the Director, Office of Nuclear Reactor Regulation and the requirements of paragraph (f)(2) of this section have been met.
(3) If the thermal annealing was terminated prior to completion, the licensee shall immediately notify the NRC of the premature termination of the thermal anneal.
(i) If the partial annealing was otherwise performed in accordance with the Thermal Annealing Operating Plan and relevant portions of the Requalification Inspection and Test Program, and the licensee does not elect to take credit for any recovery, the licensee need not submit the Thermal Annealing Results Report required by paragraph (d) of this section but instead shall confirm in writing to the Director, Office of Nuclear Reactor Regulation that the partial annealing was otherwise performed in accordance with the Thermal Annealing Operating Plan and relevant portions of the Requalification Inspection and Test Program. The licensee may restart its reactor after the requirements of paragraph (f)(2) of this section have been met.
(ii) If the partial annealing was otherwise performed in accordance with the Thermal Annealing Operating Plan and relevant portions of the Requalification Inspection and Test Program, and the licensee elects to take full or partial credit for the partial annealing, the licensee shall confirm in writing to the Director, Office of Nuclear Reactor Regulation that the partial annealing was otherwise performed in compliance with the Thermal Annealing Operating Plan and relevant portions of the Requalification Inspection and Test Program. The licensee may restart its reactor after the requirements of paragraph (f)(2) of this section have been met.
(iii) If the partial annealing was not performed in accordance with the Thermal Annealing Operating Plan and the Requalification Inspection and Test Program, the licensee shall submit a summary of lack of compliance with the Thermal Annealing Operating Plan and the Requalification Inspection and Test Program and a justification for subsequent operation to the Director, Office of Nuclear Reactor Regulation. Any changes to the facility as described in the final safety analysis report (as updated) which are attributable to the noncompliances and which require a license amendment pursuant to § 50.59(c)(2) and any changes to the technical specifications which are required as a result of the noncompliances, shall also be identified.
(A) If no changes requiring a license amendment pursuant to § 50.59(c)(2) or changes to Technical Specifications are identified, the licensee may restart its reactor after the requirements of paragraph (f)(2) of this section have been met.
(B) If any changes requiring a license amendment pursuant to § 50.59(c)(2) or changes to Technical Specifications
(d)
(1) The time and temperature profiles of the actual thermal annealing;
(2) The post-anneal RT
(3) The projected post-anneal reembrittlement trends for both RT
(4) The projected values of RT
(e)
(1) For those reactors with surveillance programs which have developed credible surveillance data as defined in § 50.61, percent recovery due to thermal annealing (R
(2) Alternatively, the percent recovery due to thermal annealing (R
(3) Generic computational methods may be used to determine recovery if adequate justification is provided.
(f)
(i) Notify and solicit comments from local and State governments in the vicinity of the site where the thermal annealing will take place and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the thermal annealing,
(ii) Publish a notice of a public meeting in the
(iii) Hold a public meeting on the licensee's Thermal Annealing Report.
(2) Within 15 days after the NRC's receipt of the licensee submissions required by paragraphs (c)(1), (c)(2) and (c)(3)(i) through (iii) of this section, the NRC staff shall make available at the NRC Web site,
(i) For the licensee to explain to NRC and the public the results of the reactor pressure vessel annealing,
(ii) for the NRC to discuss its inspection of the reactor vessel annealing, and
(iii) for the NRC to receive public comments on the annealing.
(3) Within 45 days of NRC's receipt of the licensee submissions required by paragraphs (c)(1), (c)(2) and (c)(3)(i) through (iii) of this section, the NRC staff shall complete full documentation of its inspection of the licensee's annealing process and make available
See 64 FR 53582, Oct. 4, 1999, for effectiveness of § 50.66 (b) introductory text, paragraphs (b)(4), (c)(2), and (c)(3)(iii).
(a)
(b)
(2) The NRC may issue the amendment only if the applicant's analysis demonstrates with reasonable assurance that:
(i) An individual located at any point on the boundary of the exclusion area for any 2-hour period following the onset of the postulated fission product release, would not receive a radiation dose in excess of 0.25 Sv (25 rem)
(ii) An individual located at any point on the outer boundary of the low population zone, who is exposed to the radioactive cloud resulting from the postulated fission product release (during the entire period of its passage), would not receive a radiation dose in excess of 0.25 Sv (25 rem) total effective dose equivalent (TEDE).
(iii) Adequate radiation protection is provided to permit access to and occupancy of the control room under accident conditions without personnel receiving radiation exposures in excess of 0.05 Sv (5 rem) total effective dose equivalent (TEDE) for the duration of the accident.
(a) Each holder of a construction permit or operating license for a nuclear power reactor issued under this part or a combined license for a nuclear power reactor issued under part 52 of this chapter, shall comply with either 10 CFR 70.24 of this chapter or the requirements in paragraph (b) of this section.
(b) Each licensee shall comply with the following requirements in lieu of maintaining a monitoring system capable of detecting a criticality as described in 10 CFR 70.24:
(1) Plant procedures shall prohibit the handling and storage at any one time of more fuel assemblies than have been determined to be safely subcritical under the most adverse moderation conditions feasible by unborated water.
(2) The estimated ratio of neutron production to neutron absorption and leakage (k-effective) of the fresh fuel in the fresh fuel storage racks shall be calculated assuming the racks are loaded with fuel of the maximum fuel assembly reactivity and flooded with unborated water and must not exceed 0.95, at a 95 percent probability, 95 percent confidence level. This evaluation need not be performed if administrative controls and/or design features
(3) If optimum moderation of fresh fuel in the fresh fuel storage racks occurs when the racks are assumed to be loaded with fuel of the maximum fuel assembly reactivity and filled with low-density hydrogenous fluid, the k-effective corresponding to this optimum moderation must not exceed 0.98, at a 95 percent probability, 95 percent confidence level. This evaluation need not be performed if administrative controls and/or design features prevent such moderation or if fresh fuel storage racks are not used.
(4) If no credit for soluble boron is taken, the k-effective of the spent fuel storage racks loaded with fuel of the maximum fuel assembly reactivity must not exceed 0.95, at a 95 percent probability, 95 percent confidence level, if flooded with unborated water. If credit is taken for soluble boron, the k-effective of the spent fuel storage racks loaded with fuel of the maximum fuel assembly reactivity must not exceed 0.95, at a 95 percent probability, 95 percent confidence level, if flooded with borated water, and the k-effective must remain below 1.0 (subcritical), at a 95 percent probability, 95 percent confidence level, if flooded with unborated water.
(5) The quantity of SNM, other than nuclear fuel stored onsite, is less than the quantity necessary for a critical mass.
(6) Radiation monitors are provided in storage and associated handling areas when fuel is present to detect excessive radiation levels and to initiate appropriate safety actions.
(7) The maximum nominal U-235 enrichment of the fresh fuel assemblies is limited to five (5.0) percent by weight.
(8) The FSAR is amended no later than the next update which § 50.71(e) of this part requires, indicating that the licensee has chosen to comply with § 50.68(b).
(a) Each licensee and each holder of a construction permit shall permit inspection, by duly authorized representatives of the Commission, of his records, premises, activities, and of licensed materials in possession or use, related to the license or construction permit as may be necessary to effectuate the purposes of the Act, including section 105 of the Act.
(b)(1) Each licensee and each holder of a construction permit shall upon request by the Director, Office of Nuclear Reactor Regulation, provide rent-free office space for the exclusive use of the Commission inspection personnel. Heat, air conditioning, light, electrical outlets and janitorial services shall be furnished by each licensee and each holder of a construction permit. The office shall be convenient to and have full access to the facility and shall provide the inspector both visual and acoustic privacy.
(2) For a site with a single power reactor or fuel facility licensed pursuant to part 50, the space provided shall be adequate to accommodate a full-time inspector, a part-time secretary and transient NRC personnel and will be generally commensurate with other office facilities at the site. A space of 250 square feet either within the site's office complex or in an office trailer or other on site space is suggested as a guide. For sites containing multiple power reactor units or fuel facilities, additional space may be requested to accommodate additional full-time inspector(s). The office space that is provided shall be subject to the approval of the Director, Office of Nuclear Reactor Regulation. All furniture, supplies and communication equipment will be furnished by the Commission.
(3) The licensee or construction permit holder shall afford any NRC resident inspector assigned to that site, or other NRC inspectors identified by the Regional Administrator as likely to inspect the facility, immediate unfettered access, equivalent to access provided regular plant employees, following proper identification and compliance with applicable access control meaures for security, radiological protection and personal safety.
(4) The licensee or construction permit holder (nuclear power reactor only) shall ensure that the arrival and presence of an NRC inspector, who has been
(a) Each licensee and each holder of a construction permit shall maintain all records and make all reports, in connection with the activity, as may be required by the conditions of the license or permit or by the rules, regulations, and orders of the Commission in effectuating the purposes of the Act, including section 105 of the Act. Reports must be submitted in accordance with § 50.4.
(b) With respect to any production or utilization facility of a type described in § 50.21(b) or 50.22, or a testing facility, each licensee and each holder of a construction permit shall submit its annual financial report, including the certified financial statements, to the Commission, as specified in § 50.4, upon issuance of the report.
(c) Records that are required by the regulations in this part, by license condition, or by technical specifications, must be retained for the period specified by the appropriate regulation, license condition, or technical specification. If a retention period is not otherwise specified, these records must be retained until the Commission terminates the facility license.
(d)(1) Records which must be maintained pursuant to this part may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability of producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(2) If there is a conflict between the Commission's regulations in this part, license condition, or technical specification, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this part for such records shall apply unless the Commission, pursuant to § 50.12 of this part, has granted a specific exemption from the record retention requirements specified in the regulations in this part.
(e) Each person licensed to operate a nuclear power reactor pursuant to the provisions of § 50.21 or § 50.22 of this part shall update periodically, as provided in paragraphs (e) (3) and (4) of this section, the final safety analysis report (FSAR) originally submitted as part of the application for the operating license, to assure that the information included in the report contains the latest information developed. This submittal shall contain all the changes necessary to reflect information and analyses submitted to the Commission by the licensee or prepared by the licensee pursuant to Commission requirement since the submittal of the original FSAR, or as appropriate the last update to the FSAR under this section. The submittal shall include the effects
(1) The licensee shall submit revisions containing updated information
(2) The submittal shall include (i) a certification by a duly authorized officer of the licensee that either the information accurately presents changes made since the previous submittal, necessary to reflect information and analyses submitted to the Commission or prepared pursuant to Commission requirement, or that no such changes were made; and (ii) an identification of changes made under the provisions of § 50.59 but not previously submitted to the Commission.
(3)(i) A revision of the original FSAR containing those original pages that are still applicable plus new replacement pages shall be filed within 24 months of either July 22, 1980, or the date of issuance of the operating license, whichever is later, and shall bring the FSAR up to date as of a maximum of 6 months prior to the date of filing the revision.
(ii) Not less than 15 days before § 50.71(e) becomes effective, the Director of the Office of Nuclear Reactor Regulation shall notify by letter the licensees of those nuclear power plants initially subject to the NRC's systematic evaluation program that they need not comply with the provisions of this section while the program is being conducted at their plant. The Director of the Office of Nuclear Reactor Regulation will notify by letter the licensee of each nuclear power plant being evaluated when the systematic evaluation program has been completed. Within 24 months after receipt of this notification, the licensee shall file a complete FSAR which is up to date as of a maximum of 6 months prior to the date of filing the revision.
(4) Subsequent revisions must be filed annually or 6 months after each refueling outage provided the interval between successive updates does not exceed 24 months. The revisions must reflect all changes up to a maximum of 6 months prior to the date of filling. For nuclear power reactor facilities that have submitted the certifications required by § 50.82(a)(1), subsequent revisions must be filed every 24 months.
(5) Each replacement page shall include both a change indicator for the area changed, e.g., a bold line vertically drawn in the margin adjacent to the portion actually changed, and a page change identification (date of change or change number or both).
(6) The updated FSAR shall be retained by the licensee until the Commission terminates their license.
(f) The provisions of this section apply to nuclear power reactor licensees that have submitted the certification of permanent cessation of operations required under § 50.82(a)(1)(i). The provisions of paragraphs (a), (c), and (d) of this section also apply to non-power reactor licensees that are no longer authorized to operate.
See 64 FR 53582, Oct. 4, 1999, for effectiveness of § 50.71(e) introductory text.
(a)
(i) The declaration of any of the Emergency Classes specified in the licensee's approved Emergency Plan;
(ii) Those non-emergency events specified in paragraph (b) of this section that occurred within three years of the date of discovery.
(2) If the Emergency Notification System is inoperative, the licensee shall make the required notifications via commercial telephone service, other dedicated telephone system, or any other method which will ensure
(3) The licensee shall notify the NRC immediately after notification of the appropriate State or local agencies and not later than one hour after the time the licensee declares one of the Emergency Classes.
(4) The licensee shall activate the Emergency Response Data System (ERDS)
(5) When making a report under paragraph (a)(1) of this section, the licensee shall identify:
(i) The Emergency Class declared; or
(ii) Paragraph (b)(1), “One-hour reports,” paragraph (b)(2), “Four-hour reports,” or paragraph (b)(3), “Eight-hour reports,” as the paragraph of this section requiring notification of the non-emergency event.
(b)
(2)
(i) The initiation of any nuclear plant shutdown required by the plant's Technical Specifications.
(ii)-(iii) [Reserved]
(iv)(A) Any event that results or should have resulted in emergency core cooling system (ECCS) discharge into the reactor coolant system as a result of a valid signal except when the actuation results from and is part of a pre-planned sequence during testing or reactor operation.
(B) Any event or condition that results in actuation of the reactor protection system (RPS) when the reactor is critical except when the actuation results from and is part of a pre-planned sequence during testing or reactor operation.
(v)-(x) [Reserved]
(xi) Any event or situation, related to the health and safety of the public or onsite personnel, or protection of the environment, for which a news release is planned or notification to other government agencies has been or will be made. Such an event may include an onsite fatality or inadvertent release of radioactively contaminated materials.
(3)
(i) [Reserved]
(ii) Any event or condition that results in:
(A) The condition of the nuclear power plant, including its principal safety barriers, being seriously degraded; or
(B) The nuclear power plant being in an unanalyzed condition that significantly degrades plant safety.
(iii) [Reserved]
(iv)(A) Any event or condition that results in valid actuation of any of the systems listed in paragraph (b)(3)(iv)(B) of this section, except when the actuation results from and is part of a pre-planned sequence during testing or reactor operation.
(B) The systems to which the requirements of paragraph (b)(3)(iv)(A) of this section apply are:
(
(
(
(
(
(
(
(
(v) Any event or condition that at the time of discovery could have prevented the fulfillment of the safety function of structures or systems that are needed to:
(A) Shut down the reactor and maintain it in a safe shutdown condition;
(B) Remove residual heat;
(C) Control the release of radioactive material; or
(D) Mitigate the consequences of an accident.
(vi) Events covered in paragraph (b)(3)(v) of this section may include one or more procedural errors, equipment failures, and/or discovery of design, analysis, fabrication, construction, and/or procedural inadequacies. However, individual component failures need not be reported pursuant to paragraph (b)(3)(v) of this section if redundant equipment in the same system was operable and available to perform the required safety function.
(vii)-(xi) [Reserved]
(xii) Any event requiring the transport of a radioactively contaminated person to an offsite medical facility for treatment.
(xiii) Any event that results in a major loss of emergency assessment capability, offsite response capability, or offsite communications capability (
(c)
(1)
(2)
(3) Maintain an open, continuous communication channel with the NRC Operations Center upon request by the NRC.
(a)
(2) The licensee shall report:
(i)(A) The completion of any nuclear plant shutdown required by the plant's Technical Specifications.
(B) Any operation or condition which was prohibited by the plant's Technical Specifications except when:
(
(
(
(C) Any deviation from the plant's Technical Specifications authorized pursuant to § 50.54(x) of this part.
(ii) Any event or condition that resulted in:
(A) The condition of the nuclear power plant, including its principal safety barriers, being seriously degraded; or
(B) The nuclear power plant being in an unanalyzed condition that significantly degraded plant safety.
(iii) Any natural phenomenon or other external condition that posed an actual threat to the safety of the nuclear power plant or significantly hampered site personnel in the performance of duties necessary for the safe operation of the nuclear power plant.
(iv)(A) Any event or condition that resulted in manual or automatic actuation of any of the systems listed in paragraph (a)(2)(iv)(B) of this section, except when:
(
(
(
(
(B) The systems to which the requirements of paragraph (a)(2)(iv)(A) of this section apply are:
(
(
(
(
(
(
(
(
(
(v) Any event or condition that could have prevented the fulfillment of the safety function of structures or systems that are needed to:
(A) Shut down the reactor and maintain it in a safe shutdown condition;
(B) Remove residual heat;
(C) Control the release of radioactive material; or
(D) Mitigate the consequences of an accident.
(vi) Events covered in paragraph (a)(2)(v) of this section may include one or more procedural errors, equipment failures, and/or discovery of design,
(vii) Any event where a single cause or condition caused at least one independent train or channel to become inoperable in multiple systems or two independent trains or channels to become inoperable in a single system designed to:
(A) Shut down the reactor and maintain it in a safe shutdown condition;
(B) Remove residual heat;
(C) Control the release of radioactive material; or
(D) Mitigate the consequences of an accident.
(viii)(A) Any airborne radioactive release that, when averaged over a time period of 1 hour, resulted in airborne radionuclide concentrations in an unrestricted area that exceeded 20 times the applicable concentration limits specified in appendix B to part 20, table 2, column 1.
(B) Any liquid effluent release that, when averaged over a time period of 1 hour, exceeds 20 times the applicable concentrations specified in appendix B to part 20, table 2, column 2, at the point of entry into the receiving waters (
(ix)(A) Any event or condition that as a result of a single cause could have prevented the fulfillment of a safety function for two or more trains or channels in different systems that are needed to:
(
(
(
(
(B) Events covered in paragraph (a)(2)(ix)(A) of this section may include cases of procedural error, equipment failure, and/or discovery of a design, analysis, fabrication, construction, and/or procedural inadequacy. However, licensees are not required to report an event pursuant to paragraph (a)(2)(ix)(A) of this section if the event results from:
(
(
(x) Any event that posed an actual threat to the safety of the nuclear power plant or significantly hampered site personnel in the performance of duties necessary for the safe operation of the nuclear power plant including fires, toxic gas releases, or radioactive releases.
(b)
(1) A brief abstract describing the major occurrences during the event, including all component or system failures that contributed to the event and significant corrective action taken or planned to prevent recurrence.
(2)(i) A clear, specific, narrative description of what occurred so that knowledgeable readers conversant with the design of commercial nuclear power plants, but not familiar with the details of a particular plant, can understand the complete event.
(ii) The narrative description must include the following specific information as appropriate for the particular event:
(A) Plant operating conditions before the event.
(B) Status of structures, components, or systems that were inoperable at the start of the event and that contributed to the event.
(C) Dates and approximate times of occurrences.
(D) The cause of each component or system failure or personnel error, if known.
(E) The failure mode, mechanism, and effect of each failed component, if known.
(F) The Energy Industry Identification System component function identifier and system name of each component or system referred to in the LER.
(
(
(
(G) For failures of components with multiple functions, include a list of systems or secondary functions that were also affected.
(H) For failure that rendered a train of a safety system inoperable, an estimate of the elapsed time from the discovery of the failure until the train was returned to service.
(I) The method of discovery of each component or system failure or procedural error.
(J) For each human performance related root cause, the licensee shall discuss the cause(s) and circumstances.
(K) Automatically and manually initiated safety system responses.
(L) The manufacturer and model number (or other identification) of each component that failed during the event.
(3) An assessment of the safety consequences and implications of the event. This assessment must include:
(i) The availability of systems or components that could have performed the same function as the components and systems that failed during the event, and
(ii) For events that occurred when the reactor was shutdown, the availability of systems or components that are needed to shutdown the reactor and maintain safe shutdown conditions, remove residual heat, control the release of radioactive material, or mitigate the consequences of an accident.
(4) A description of any corrective actions planned as a result of the event, including those to reduce the probability of similar events occurring in the future.
(5) Reference to any previous similar events at the same plant that are known to the licensee.
(6) The name and telephone number of a person within the licensee's organization who is knowledgeable about the event and can provide additional information concerning the event and the plant's characteristics.
(c)
(d)
(e)
(f) [Reserved]
(g)
Each licensee shall notify the Commission in accordance with § 50.4 within
(a) Permanent reassignment from the position for which the licensee has certified the need for a licensed operator or senior operator under § 55.31(a)(3) of this chapter;
(b) Termination of any operator or senior operator;
(c) Permanent disability or illness as described in § 55.25 of this chapter.
(a) This section establishes requirements for indicating to NRC how a licensee will provide reasonable assurance that funds will be available for the decommissioning process. For power reactor licensees, reasonable assurance consists of a series of steps as provided in paragraphs (b), (c), (e), and (f) of this section. Funding for the decommissioning of power reactors may also be subject to the regulation of Federal or State Government agencies (e.g., Federal Energy Regulatory Commission (FERC) and State Public Utility Commissions) that have jurisdiction over rate regulation. The requirements of this section, in particular paragraph (c) of this section, are in addition to, and not substitution for, other requirements, and are not intended to be used, by themselves, by other agencies to establish rates.
(b) Each power reactor applicant for or holder of an operating license for a production or utilization facility of the type and power level specified in paragraph (c) of this section shall submit a decommissioning report, as required by § 50.33(k) of this part.
(1) The report must contain a certification that financial assurance for decommissioning will be (for a license applicant) or has been (for a license holder) provided in an amount which may be more but not less than the amount stated in the table in paragraph (c)(1) of this section.
(2) The amount to be provided must be adjusted annually using a rate at least equal to that stated in paragraph (c)(2) of this section.
(3) The amount must use one or more of the methods described in paragraph (e) of this section as acceptable to the NRC.
(4) The amount stated in the applicant's or licensee's certification may be based on a cost estimate for decommissioning the facility. As part of the certification, a copy of the financial instrument obtained to satisfy the requirements of paragraph (e) of this section must be submitted to NRC.
(c) Table of minimum amounts (January 1986 dollars) required to demonstrate reasonable assurance of funds for decommissioning by reactor type and power level, P (in MWt); adjustment factor.
(2) An adjustment factor at least equal to 0.65 L + 0.13 E + 0.22 B is to be used where L and E are escalation factors for labor and energy, respectively, and are to be taken from regional data of U.S. Department of Labor Bureau of Labor Statistics and B is an escalation factor for waste burial and is to be taken from NRC report NUREG-1307, “Report on Waste Burial Charges.”
(d)(1) Each non-power reactor applicant for or holder of an operating license for a production or utilization facility shall submit a decommissioning report as required by § 50.33(k) of this part.
(2) The report must:
(i) Contain a cost estimate for decommissioning the facility;
(ii) Indicate which method or methods described in paragraph (e) of this
(iii) Provide a description of the means of adjusting the cost estimate and associated funding level periodically over the life of the facility.
(e)(1) Financial assurance is to be provided by the following methods.
(i)
(ii)
(A) By a licensee that recovers, either directly or indirectly, the estimated total cost of decommissioning through rates established by “cost of service” or similar ratemaking regulation. Public utility districts, municipalities, rural electric cooperatives, and State and Federal agencies, including associations of any of the foregoing, that establish their own rates and are able to recover their cost of service allocable to decommissioning, are assumed to meet this condition.
(B) By a licensee whose source of revenues for its external sinking fund is a “non-bypassable charge,” the total amount of which will provide funds estimated to be needed for decommissioning pursuant to §§ 50.75(c), 50.75(f), or 50.82 of this part.
(iii) A surety method, insurance, or other guarantee method:
(A) These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:
(
(
(B) A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix A to 10 CFR part 30.
(C) For commercial companies that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix C to 10 CFR part 30. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in appendix D to 10 CFR part 30. For non-profit entities, such as colleges, universities, and non-profit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in appendix E to 10 CFR part 30. A guarantee by the applicant or licensee may not be used in any situation in which the applicant or licensee has a parent company holding majority control of voting stock of the company.
(iv) For a power reactor licensee that is a Federal licensee, or for a non-power reactor licensee that is a Federal, State, or local government licensee, a statement of intent containing a cost estimate for decommissioning, and indicating that funds for decommissioning will be obtained when necessary.
(v) Contractual obligation(s) on the part of a licensee's customer(s), the total amount of which over the duration of the contract(s) will provide the licensee's total share of uncollected funds estimated to be needed for decommissioning pursuant to §§ 50.75(c), 50.75(f), or § 50.82. To be acceptable to the NRC as a method of decommissioning funding assurance, the terms of the contract(s) shall include provisions that the electricity buyer(s) will pay for the decommissioning obligations specified in the contract(s), notwithstanding the operational status either of the licensed power reactor to which the contract(s) pertains or force majeure provisions. All proceeds from the contract(s) for decommissioning funding will be deposited to the external sinking fund. The NRC reserves the right to evaluate the terms of any contract(s) and the financial qualifications of the contracting entity(ies) offered as assurance for decommissioning funding.
(vi) Any other mechanism, or combination of mechanisms, that provides, as determined by the NRC upon its evaluation of the specific circumstances of each licensee submittal, assurance of decommissioning funding equivalent to that provided by the mechanisms specified in paragraphs (e)(1)(i) through (v) of this section. Licensees who do not have sources of funding described in paragraph (e)(1)(ii) of this section may use an external sinking fund in combination with a guarantee mechanism, as specified in paragraph (e)(1)(iii) of this section, provided that the total amount of funds estimated to be necessary for decommissioning is assured.
(2) The NRC reserves the right to take the following steps in order to ensure a licensee's adequate accumulation of decommissioning funds: review, as needed, the rate of accumulation of decommissioning funds; and, either independently or in cooperation with the FERC and the licensee's State PUC, take additional actions as appropriate on a case-by-case basis, including modification of a licensee's schedule for the accumulation of decommissioning funds.
(f)(1) Each power reactor licensee shall report, on a calendar-year basis, to the NRC by March 31, 1999, and at least once every 2 years thereafter on the status of its decommissioning funding for each reactor or part of a reactor that it owns. The information in this report must include, at a minimum: the amount of decommissioning funds estimated to be required pursuant to 10 CFR 50.75 (b) and (c); the amount accumulated to the end of the calendar year
(2) Each power reactor licensee shall at or about 5 years prior to the projected end of operations submit a preliminary decommissioning cost estimate which includes an up-to-date assessment of the major factors that could affect the cost to decommission.
(3) Each non-power reactor licensee shall at or about 2 years prior to the projected end of operations submit a preliminary decommissioning plan containing a cost estimate for decommissioning and an up-to-date assessment of the major factors that could affect planning for decommissioning. Factors to be considered in submitting this preliminary plan information include—
(i) The decommissioning alternative anticipated to be used. The requirements of § 50.82(b)(4)(i) must be considered at this time;
(ii) Major technical actions necessary to carry out decommissioning safely;
(iii) The current situation with regard to disposal of high-level and low-level radioactive waste;
(iv) Residual radioactivity criteria;
(v) Other site specific factors which could affect decommissioning planning and cost.
(4) If necessary, the cost estimate, for power and non-power reactors, shall also include plans for adjusting levels of funds assured for decommissioning to demonstrate that a reasonable level of assurance will be provided that funds will be available when needed to cover the cost of decommissioning.
(g) Each licensee shall keep records of information important to the safe and effective decommissioning of the facility in an identified location until the license is terminated by the Commission. If records of relevant information are kept for other purposes, reference to these records and their locations may be used. Information the Commission considers important to decommissioning consists of—
(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when significant contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.
(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.
(3) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.
At 67 FR 78350, Dec. 24, 2002, § 50.75 was amended by revising the introductory text of paragraph (e)(1) and paragraphs (e)(1)(i) and (e)(1)(ii), and adding paragraph (h), effective Dec. 24, 2003. For the
(e)(1) Financial assurance is to be provided by the following methods.
(i)
(ii)
(h)(1) Licensees that are not “electric utilities” as defined in § 50.2 that use prepayment or an external sinking fund to provide financial assurance shall provide in the terms of the arrangements governing the trust, escrow account, or Government fund, used to segregate and manage the funds that—
(i) The trustee, manager, investment advisor, or other person directing investment of the funds:
(A) Is prohibited from investing the funds in securities or other obligations of the licensee or any other owner or operator of the power reactor or their affiliates, subsidiaries, successors or assigns, or in a mutual fund in which at least 50 percent of the fund is invested in the securities of a licensee or parent company whose subsidiary is an owner of a foreign or domestic nuclear power plant. However, the funds may be invested in securities tied to market indices or other non-nuclear sector collective, commingled, or mutual funds, provided that this subsection shall not operate in such a way as to require the sale or transfer either in whole or in part, or other disposition of any such prohibited investment that was made before the publication date of this rule, provided further that these restrictions do not apply to 10 percent or less of their trust assets in securities of any other entity owning one or more nuclear power plants.
(B) Is obligated at all times to adhere to a standard of care set forth in the trust, which either shall be the standard of care, whether in investing or otherwise, required by State or Federal law or one or more State or Federal regulatory agencies with jurisdiction over the trust funds, or, in the absence of any such care, whether in investing or otherwise, that a prudent investor would use in the same circumstances. The term “prudent investor,” shall have the same meaning as set forth in the Federal Energy Regulatory Commission's “Regulations Governing Nuclear Plant Decommissioning Trust Funds” at 18 CFR 35.32(a)(3), or any successor regulation.
(ii) The licensee, its affiliates, and its subsidiaries are prohibited from being engaged as investment manager for the funds or from giving day-to-day management direction of the funds' investments or direction on individual investments by the funds, except in the case of passive fund management of trust funds where management is limited to investments tracking market indices.
(iii) The trust, escrow account, Government fund, or other account used to segregate and manage the funds may not be amended in any material respect without written notification to the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as applicable, at least 30 working days before the proposed effective date of the amendment. The licensee shall provide the text of the proposed amendment and a statement of the reason for the proposed amendment. The trust, escrow account, Government fund, or other account may not be amended if the person responsible for managing the trust, escrow account, Government fund, or other account receives written notice of objection from the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as applicable, within the notice period; and
(iv) Except for withdrawals being made under 10 CFR 50.82(a)(8), no disbursement or payment may be made from the trust, escrow account, Government fund, or other account used to segregate and manage the funds until written notice of the intention to make a disbursement or payment has been given to the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as applicable, at least 30 working days before the date of the intended disbursement or payment. The disbursement or payment from the trust, escrow account, Government fund or other account may be made following the 30-working day notice period if the person responsible for managing the trust, escrow account, Government fund, or other account does not receive written notice of objection from the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as applicable, within the notice period. Disbursements or payments from the trust, escrow account, Government fund, or other account used to segregate and manage the funds, other than for payment of ordinary administrative costs (including taxes) and other incidental expenses of the fund (including legal, accounting, actuarial, and trustee expenses) in connection with the operation of the fund, are restricted to decommissioning expenses or transfer to another financial assurance method acceptable under paragraph (e) of this section until final decommissioning has been completed. After decommissioning has begun and withdrawals from the decommissioning fund are made under 10 CFR 50.82(a)(8), no further notification need be made to the NRC.
(2) Licensees that are “electric utilities” under § 50.2 that use prepayment or an external sinking fund to provide financial assurance shall provide in the terms of the trust, escrow account, Government fund, or other account used to segregate and manage funds that except for withdrawals being made under 10 CFR 50.82(a)(8), no disbursement or payment may be made from the trust, escrow account, Government fund, or other account used to segregate and manage the funds until written notice of the intention to make a disbursement or payment has been given the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as applicable, at least 30 working days before the date of the intended disbursement or payment. The disbursement or payment from the trust, escrow account, Government fund or other account may be made following the
(3) A licensee that is not an “electric utility” under § 50.2 and using a surety method, insurance, or other guarantee method to provide financial assurance shall provide that the trust established for decommissioning costs to which the surety or insurance is payable contains in its terms the requirements in paragraphs (h)(1)(i), (ii), (iii), and (iv) of this section.
(4) Unless otherwise determined by the Commission with regard to a specific application, the Commission has determined that any amendment to the license of a utilization facility that does no more than delete specific license conditions relating to the terms and conditions of decommissioning trust agreements involves “no significant hazards consideration.”
Each holder of a construction permit shall, if requested by the Commission, submit installation information on Form N-71, permit verification thereof by the International Atomic Energy Agency, and take such other action as may be necessary to implement the US/IAEA Safeguards Agreement, in the manner set forth in §§ 75.6 and 75.11 through 75.14 of this chapter.
(a) No license for a production or utilization facility, or any right thereunder, shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission shall give its consent in writing.
(b) An application for transfer of a license shall include as much of the information described in §§ 50.33 and 50.34 of this part with respect to the identity and technical and financial qualifications of the proposed transferee as would be required by those sections if the application were for an initial license, and, if the license to be issued is a class 103 construction permit or initial operating license, the information required by § 50.33a. The Commission may require additional information such as data respecting proposed safeguards against hazards from radioactive materials and the applicant's qualifications to protect against such hazards. The application shall include also a statement of the purposes for which the transfer of the license is requested, the nature of the transaction necessitating or making desirable the transfer of the license, and an agreement to limit access to Restricted Data pursuant to § 50.37. The Commission may require any person who submits an application for license pursuant to the provisions of this section to file a written consent from the existing licensee or a certified copy of an order or judgment of a court of competent jurisdiction attesting to the person's right (subject to the licensing requirements of the Act and these regulations) to possession of the facility involved.
(c) After appropriate notice to interested persons, including the existing licensee, and observance of such procedures as may be required by the Act or regulations or orders of the Commission, the Commission will approve an application for the transfer of a license, if the Commission determines:
(1) That the proposed transferee is qualified to be the holder of the license; and
(2) That transfer of the license is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto.
(a) Pursuant to section 184 of the Act, the Commission consents, without individual application, to the creation of any mortgage, pledge, or other lien upon any production or utilization facility not owned by the United States which is the subject of a license or upon any leasehold or other interest in such facility:
(1) That the rights of any creditor so secured may be exercised only in compliance with and subject to the same requirements and restrictions as would apply to the licensee pursuant to the provisions of the license, the Atomic Energy Act of 1954, as amended, and regulations issued by the Commission pursuant to said Act; and
(2) That no creditor so secured may take possession of the facility pursuant to the provisions of this section prior to either the issuance of a license from the Commission authorizing such possession or the transfer of the license.
(b) Any creditor so secured may apply for transfer of the license covering such facility by filing an application for transfer of the license pursuant to § 50.80(b). The Commission will act upon such application pursuant to § 50.80 (c).
(c) Nothing contained in this regulation shall be deemed to affect the means of acquiring, or the priority of, any tax lien or other lien provided by law.
(d) As used in this section: (1) “License” includes any license or construction permit which may be issued by the Commission with regard to the facility;
(2) “Creditor” includes, without implied limitation, the trustee under any mortgage, pledge or lien on a facility made to secure any creditor, any trustee or receiver of the facility appointed by a court of competent jurisdiction in any action brought for the benefit of any creditor secured by such mortgage, pledge or lien, any purchaser of such facility at the sale thereof upon foreclosure of such mortgage, pledge, or lien or upon exercise of any power of sale contained therein, or any assignee of any such purchaser.
For power reactor licensees who, before the effective date of this rule, either submitted a decommissioning plan for approval or possess an approved decommissioning plan, the plan is considered to be the PSDAR submittal required under paragraph (a)(4) of this section and the provisions of this section apply accordingly. For power reactor licensees whose decommissioning plan approval activities have been relegated to notice of opportunity for a hearing under subpart G of 10 CFR part 2, the public meeting convened and 90-day delay of major decommissioning activities required in paragraphs (a)(4)(ii) and (a)(5) of this section shall not apply, and any orders arising from proceedings under subpart G of 10 CFR part 2 shall continue and remain in effect absent any orders from the Commission.
(a) For power reactor licensees—
(1)(i) When a licensee has determined to permanently cease operations the licensee shall, within 30 days, submit a written certification to the NRC, consistent with the requirements of § 50.4(b)(8);
(ii) Once fuel has been permanently removed from the reactor vessel, the licensee shall submit a written certification to the NRC that meets the requirements of § 50.4(b)(9) and;
(iii) For licensees whose licenses have been permanently modified to allow possession but not operation of the facility, before the effective date of this rule, the certifications required in paragraphs (a)(1) (i)-(ii) of this section shall be deemed to have been submitted.
(2) Upon docketing of the certifications for permanent cessation of operations and permanent removal of fuel from the reactor vessel, or when a final
(3) Decommissioning will be completed within 60 years of permanent cessation of operations. Completion of decommissioning beyond 60 years will be approved by the Commission only when necessary to protect public health and safety. Factors that will be considered by the Commission in evaluating an alternative that provides for completion of decommissioning beyond 60 years of permanent cessation of operations include unavailability of waste disposal capacity and other site-specific factors affecting the licensee's capability to carry out decommissioning, including presence of other nuclear facilities at the site.
(4) (i) Prior to or within 2 years following permanent cessation of operations, the licensee shall submit a post-shutdown decommissioning activities report (PSDAR) to the NRC, and a copy to the affected State(s). The report must include a description of the planned decommissioning activities along with a schedule for their accomplishment, an estimate of expected costs, and a discussion that provides the reasons for concluding that the environmental impacts associated with site-specific decommissioning activities will be bounded by appropriate previously issued environmental impact statements.
(ii) The NRC shall notice receipt of the PSDAR and make the PSDAR available for public comment. The NRC shall also schedule a public meeting in the vicinity of the licensee's facility upon receipt of the PSDAR. The NRC shall publish a notice in the
(5) Licensees shall not perform any major decommissioning activities, as defined in § 50.2, until 90 days after the NRC has received the licensee's PSDAR submittal and until certifications of permanent cessation of operations and permanent removal of fuel from the reactor vessel, as required under § 50.82(a)(1), have been submitted.
(6) Licensees shall not perform any decommissioning activities, as defined in § 50.2, that—
(i) Foreclose release of the site for possible unrestricted use;
(ii) Result in significant environmental impacts not previously reviewed; or
(iii) Result in there no longer being reasonable assurance that adequate funds will be available for decommissioning.
(7) In taking actions permitted under § 50.59 following submittal of the PSDAR, the licensee shall notify the NRC, in writing and send a copy to the affected State(s), before performing any decommissioning activity inconsistent with, or making any significant schedule change from, those actions and schedules described in the PSDAR, including changes that significantly increase the decommissioning cost.
(8)(i) Decommissioning trust funds may be used by licensees if—
(A) The withdrawals are for expenses for legitimate decommissioning activities consistent with the definition of decommissioning in § 50.2;
(B) The expenditure would not reduce the value of the decommissioning trust below an amount necessary to place and maintain the reactor in a safe storage condition if unforeseen conditions or expenses arise and;
(C) The withdrawals would not inhibit the ability of the licensee to complete funding of any shortfalls in the decommissioning trust needed to ensure the availability of funds to ultimately release the site and terminate the license.
(ii) Initially, 3 percent of the generic amount specified in § 50.75 may be used for decommissioning planning. For licensees that have submitted the certifications required under § 50.82(a)(1) and commencing 90 days after the NRC has received the PSDAR, an additional 20 percent may be used. A site-specific decommissioning cost estimate must be submitted to the NRC prior to the licensee using any funding in excess of these amounts.
(iii) Within 2 years following permanent cessation of operations, if not already submitted, the licensee shall submit a site-specific decommissioning cost estimate.
(iv) For decommissioning activities that delay completion of decommissioning by including a period of storage or surveillance, the licensee shall provide a means of adjusting cost estimates and associated funding levels over the storage or surveillance period.
(9) All power reactor licensees must submit an application for termination of license. The application for termination of license must be accompanied or preceded by a license termination plan to be submitted for NRC approval.
(i) The license termination plan must be a supplement to the FSAR or equivalent and must be submitted at least 2 years before termination of the license date.
(ii) The license termination plan must include—
(A) A site characterization;
(B) Identification of remaining dismantlement activities;
(C) Plans for site remediation;
(D) Detailed plans for the final radiation survey;
(E) A description of the end use of the site, if restricted;
(F) An updated site-specific estimate of remaining decommissioning costs; and
(G) A supplement to the environmental report, pursuant to § 51.53, describing any new information or significant environmental change associated with the licensee's proposed termination activities.
(iii) The NRC shall notice receipt of the license termination plan and make the license termination plan available for public comment. The NRC shall also schedule a public meeting in the vicinity of the licensee's facility upon receipt of the license termination plan. The NRC shall publish a notice in the
(10) If the license termination plan demonstrates that the remainder of decommissioning activities will be performed in accordance with the regulations in this chapter, will not be inimical to the common defense and security or to the health and safety of the public, and will not have a significant effect on the quality of the environment and after notice to interested persons, the Commission shall approve the plan, by license amendment, subject to such conditions and limitations as it deems appropriate and necessary and authorize implementation of the license termination plan.
(11) The Commission shall terminate the license if it determines that—
(i) The remaining dismantlement has been performed in accordance with the approved license termination plan, and
(ii) The terminal radiation survey and associated documentation demonstrates that the facility and site are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E.
(b) For non-power reactor licensees—
(1) A licensee that permanently ceases operations must make application for license termination within 2 years following permanent cessation of operations, and in no case later than 1 year prior to expiration of the operating license. Each application for termination of a license must be accompanied or preceded by a proposed decommissioning plan. The contents of the decommissioning plan are specified in paragraph (b)(4) of this section.
(2) For decommissioning plans in which the major dismantlement activities are delayed by first placing the facility in storage, planning for these delayed activities may be less detailed. Updated detailed plans must be submitted and approved prior to the start of these activities.
(3) For decommissioning plans that delay completion of decommissioning by including a period of storage or surveillance, the licensee shall provide that—
(i) Funds needed to complete decommissioning be placed into an account segregated from the licensee's assets and outside the licensee's administrative control during the storage or surveillance period, or a surety method or fund statement of intent be maintained
(ii) Means be included for adjusting cost estimates and associated funding levels over the storage or surveillance period.
(4) The proposed decommissioning plan must include—
(i) The choice of the alternative for decommissioning with a description of activities involved. An alternative is acceptable if it provides for completion of decommissioning without significant delay. Consideration will be given to an alternative which provides for delayed completion of decommissioning only when necessary to protect the public health and safety. Factors to be considered in evaluating an alternative which provides for delayed completion of decommissioning include unavailability of waste disposal capacity and other site-specific factors affecting the licensee's capability to carry out decommissioning, including the presence of other nuclear facilities at the site.
(ii) A description of the controls and limits on procedures and equipment to protect occupational and public health and safety;
(iii) A description of the planned final radiation survey;
(iv) An updated cost estimate for the chosen alternative for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequate funds for completion of decommissioning; and
(v) A description of technical specifications, quality assurance provisions and physical security plan provisions in place during decommissioning.
(5) If the decommissioning plan demonstrates that the decommissioning will be performed in accordance with the regulations in this chapter and will not be inimical to the common defense and security or to the health and safety of the public, and after notice to interested persons, the Commission will approve, by amendment, the plan subject to such conditions and limitations as it deems appropriate and necessary. The approved decommissioning plan will be a supplement to the Safety Analysis report or equivalent.
(6) The Commission will terminate the license if it determines that—
(i) The decommissioning has been performed in accordance with the approved decommissioning plan, and
(ii) The terminal radiation survey and associated documentation demonstrate that the facility and site are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E.
(c) For a facility that has permanently ceased operation before the expiration of its license, the collection period for any shortfall of funds will be determined, upon application by the licensee, on a case-by-case basis taking into account the specific financial situation of each licensee.
Whenever a holder of a license or construction permit desires to amend the license (including the Technical Specifications incorporated into the license) or permit, application for an amendment must be filed with the Commission, as specified in § 50.4, fully describing the changes desired, and following as far as applicable, the form prescribed for original applications.
See 64 FR 53582, Oct. 4, 1999, for effectiveness of § 50.90.
The Commission will use the following procedures for an application requesting an amendment to an operating license for a facility licensed under § 50.21(b) or § 50.22 or for a testing facility, except for amendments subject to hearings governed by §§ 2.1201-2.1263 of this chapter. For amendments subject to §§ 2.1201-2.1263 of this chapter, the following procedures will apply only to the extent specifically referenced in § 2.1205 (c) and (d) of this chapter:
(a)
(2)(i) The Commission may publish in the
(ii) For each amendment proposed to be issued, the notice will (A) contain the staff's proposed determination, under the standards in § 50.92, (B) provide a brief description of the amendment and of the facility involved, (C) solicit public comments on the proposed determination, and (D) provide for a 30-day comment period.
(iii) The comment period will begin on the day after the date of the publication of the first notice, and, normally, the amendment will not be granted until after this comment period expires.
(3) The Commission may inform the public about the final disposition of an amendment request for which it has made a proposed determination of no significant hazards consideration either by issuing an individual notice of issuance under § 2.106 of this chapter or by publishing such a notice in its periodic system of
(4) Where the Commission makes a final determination that no significant hazards consideration is involved and that the amendment should be issued, the amendment will be effective upon issuance, even if adverse public comments have been received and even if an interested person meeting the provisions for intervention called for in § 2.714 of this chapter has filed a request for a hearing. The Commission need hold any required hearing only after it issues an amendment, unless it determines that a significant hazards consideration is involved in which case the Commission will provide an opportunity for a prior hearing.
(5) Where the Commission finds that an emergency situation exists, in that failure to act in a timely way would result in derating or shutdown of a nuclear power plant, or in prevention of either resumption of operation or of increase in power output up to the plant's licensed power level, it may issue a license amendment involving no significant hazards consideration without prior notice and opportunity for a hearing or for public comment. In such a situation, the Commission will not publish a notice of proposed determination on no significant hazards consideration, but will publish a notice of issuance under § 2.106 of this chapter, providing for opportunity for a hearing and for public comment after issuance. The Commission expects its licensees to apply for license amendments in timely fashion. It will decline to dispense with notice and comment on the determination of no significant hazards consideration if it determines that the licensee has abused the emergency provision by failing to make timely application for the amendment and thus itself creating the emergency. Whenever an emergency situation exists, a licensee requesting an amendment must explain why this emergency situation occurred and why it could not avoid this situation, and the Commission will assess the licensee's reasons for failing to file an application sufficiently in advance of that event.
(6) Where the Commission finds that exigent circumstances exist, in that a licensee and the Commission must act quickly and that time does not permit the Commission to publish a
(i)(A) Will either issue a
(B) Will use local media to provide reasonable notice to the public in the area surrounding a licensee's facility of the licensee's amendment and of its proposed determination as described in paragraph (a)(2) of this section, consulting with the licensee on the proposed media release and on the geographical area of its coverage;
(ii) Will provide for a reasonable opportunity for the public to comment, using its best efforts to make available to the public whatever means of communication it can for the public to respond quickly, and, in the case of telephone comments, have these comments recorded or transcribed, as necessary and appropriate;
(iii) When it has issued a local media release, may inform the licensee of the public's comments, as necessary and appropriate;
(iv) Will publish a notice of issuance under § 2.106;
(v) Will provide a hearing after issuance, if one has been requested by a person who satisfies the provisions for intervention called for in § 2.714 of this chapter;
(vi) Will require the licensee to explain the exigency and why the licensee cannot avoid it, and use its normal public notice and comment procedures in paragraph (a)(2) of this section if it determines that the licensee has failed to use its best efforts to make a timely application for the amendment in order to create the exigency and to take advantage of this procedure.
(7) Where the Commission finds that significant hazards considerations are involved, it will issue a
(b)
(2) The Commission will advise the State of its proposed determination about no significant hazards consideration normally by sending it a copy of the
(3) The Commission will make available to the State official designated to consult with it about its proposed determination the names of the Project Manager or other NRC personnel it designated to consult with the State. The Commission will consider any comments of that State official. If it does not hear from the State in a timely manner, it will consider that the State has no interest in its determination; nonetheless, to ensure that the State is aware of the application, before it issues the amendment, it will make a good faith effort to telephone that official. (Inability to consult with a responsible State official following good faith attempts will not prevent the Commission from making effective a license amendment involving no significant hazards consideration.)
(4) The Commission will make a good faith attempt to consult with the State before it issues a license amendment involving no significant hazards consideration. If, however, it does not have time to use its normal consultation procedures because of an emergency situation, it will attempt to telephone the appropriate State official. (Inability to consult with a responsible State official following good faith attempts will not prevent the Commission from making effective a license amendment involving no significant hazards consideration, if the Commission deems it necessary in an emergency situation.)
(5) After the Commission issues the requested amendment, it will send a copy of its determination to the State.
(c)
(i) To veto the Commission's proposed or final determination;
(ii) To a hearing on the determination before the amendment becomes effective; or
(iii) To insist upon a postponement of the determination or upon issuance of the amendment.
(2) These procedures do not alter present provisions of law that reserve to the Commission exclusive responsibility for setting and enforcing radiological health and safety requirements for nuclear power plants.
(a) In determining whether an amendment to a license or construction permit will be issued to the applicant, the Commission will be guided by the considerations which govern the issuance of initial licenses or construction permits to the extent applicable and appropriate. If the application involves the material alteration of a licensed facility, a construction permit will be issued before the issuance of the amendment to the license. If the amendment involves a significant hazards consideration, the Commission will give notice of its proposed action (1) pursuant to § 2.105 of this chapter before acting thereon and (2) as soon as practicable after the application has been docketed.
(b) The Commission will be particularly sensitive to a license amendment request that involves irreversible consequences (such as one that permits a significant increase in the amount of effluents or radiation emitted by a nuclear power plant).
(c) The Commission may make a final determination, pursuant to the procedures in § 50.91, that a proposed amendment to an operating license for a facility licensed under § 50.21(b) or § 50.22 or for a testing facility involves no significant hazards consideration, if operation of the facility in accordance with the proposed amendment would not:
(1) Involve a significant increase in the probability or consequences of an accident previously evaluated; or
(2) Create the possibility of a new or different kind of accident from any accident previously evaluated; or
(3) Involve a significant reduction in a margin of safety.
A license or construction permit may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application for license or in the supplemental or other statement of fact required of the applicant; or because of conditions revealed by the application for license or statement of fact or any report, record, inspection, or other means, which would warrant the Commission to refuse to grant a license on an original application (other than those relating to §§ 50.51, 50.42(a), and 50.43(b) of this part); or for failure to construct or operate a facility in accordance with the terms of the construction permit or license, provided that failure to make timely completion of the proposed construction or alteration of a facility under a construction permit shall be governed by the provisions of § 50.55(b); or for violation of, or failure to observe, any of the terms and provisions of the act, regulations, license, permit, or order of the Commission.
Upon revocation of a license, the Commission may immediately cause the retaking of possession of all special nuclear material held by the licensee.
Whenever the Commission finds that the public convenience and necessity, or the Department finds that the production program of the Department requires continued operation of a production or utilization facility, the license for which has been revoked, the Commission may, after consultation with the appropriate federal or state regulatory agency having jurisdiction, order that possession be taken of such facility and that it be operated for a period of time as, in the judgment of
(a) Whenever Congress declares that a state of war or national emergency exists, the Commission, if it finds it necessary to the common defense and security, may,
(1) Suspend any license it has issued.
(2) Cause the recapture of special nuclear material.
(3) Order the operation of any licensed facility.
(4) Order entry into any plant or facility in order to recapture special nuclear material or to operate the facility.
(b) Just compensation shall be paid for any damages caused by recapture of special nuclear material or by operation of any facility, pursuant to this section.
(a)(1) Backfitting is defined as the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position after:
(i) The date of issuance of the construction permit for the facility for facilities having construction permits issued after October 21, 1985; or
(ii) Six months before the date of docketing of the operating license application for the facility for facilities having construction permits issued before October 21, 1985; or
(iii) The date of issuance of the operating license for the facility for facilities having operating licenses; or
(iv) The date of issuance of the design approval under appendix M, N, or O of part 52.
(2) Except as provided in paragraph (a)(4) of this section, the Commission shall require a systematic and documented analysis pursuant to paragraph (c) of this section for backfits which it seeks to impose.
(3) Except as provided in paragraph (a)(4) of this section, the Commission shall require the backfitting of a facility only when it determines, based on the analysis described in paragraph (c) of this section, that there is a substantial increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit and that the direct and indirect costs of implementation for that facility are justified in view of this increased protection.
(4) The provisions of paragraphs (a)(2) and (a)(3) of this section are inapplicable and, therefore, backfit analysis is not required and the standards in paragraph (a)(3) of this section do not apply where the Commission or staff, as appropriate, finds and declares, with appropriated documented evaluation for its finding, either:
(i) That a modification is necessary to bring a facility into compliance with a license or the rules or orders of the Commission, or into conformance with written commitments by the licensee; or
(ii) That regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security; or
(iii) That the regulatory action involves defining or redefining what level of protection to the public health and safety or common defense and security should be regarded as adequate.
(5) The Commission shall always require the backfitting of a facility if it determines that such regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security.
(6) The documented evaluation required by paragraph (a)(4) of this section shall include a statement of the objectives of and reasons for the modification and the basis for invoking the exception. If immediately effective regulatory action is required, then the documented evaluation may follow rather than precede the regulatory action.
(7) If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or with written licensee commitments, or there are two or more ways to reach a level of protection which is adequate, then ordinarily the applicant or licensee is free to choose the way which best suits its purposes. However, should it be necessary or appropriate for the Commission to prescribe a specific way to comply with its requirements or to achieve adequate protection, then cost may be a factor in selecting the way, provided that the objective of compliance or adequate protection is met.
(b) Paragraph (a)(3) of this section shall not apply to backfits imposed prior to October 21, 1985.
(c) In reaching the determination required by paragraph (a)(3) of this section, the Commission will consider how the backfit should be scheduled in light of other ongoing regulatory activities at the facility and, in addition, will consider information available concerning any of the following factors as may be appropriate and any other information relevant and material to the proposed backfit:
(1) Statement of the specific objectives that the proposed backfit is designed to achieve;
(2) General description of the activity that would be required by the licensee or applicant in order to complete the backfit;
(3) Potential change in the risk to the public from the accidental off-site release of radioactive material;
(4) Potential impact on radiological exposure of facility employees;
(5) Installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay;
(6) The potential safety impact of changes in plant or operational complexity, including the relationship to proposed and existing regulatory requirements;
(7) The estimated resource burden on the NRC associated with the proposed backfit and the availability of such resources;
(8) The potential impact of differences in facility type, design or age on the relevancy and practicality of the proposed backfit;
(9) Whether the proposed backfit is interim or final and, if interim, the justification for imposing the proposed backfit on an interim basis.
(d) No licensing action will be withheld during the pendency of backfit analyses required by the Commission's rules.
(e) The Executive Director for Operations shall be responsible for implementation of this section, and all analyses required by this section shall be approved by the Executive Director for Operations or his designee.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended; or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under Section 234 of the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.
(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 50 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.
(b) The regulations in 10 CFR part 50 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 50.1, 50.2, 50.3, 50.4, 50.8, 50.11, 50.12, 50.13, 50.20, 50.21, 50.22, 50.23, 50.30, 50.31, 50.32, 50.33, 50.34a, 50.35, 50.36b, 50.37, 50.38, 50.39, 50.40, 50.41, 50.42, 50.43, 50.45, 50.50, 50.51, 50.52, 50.53, 50.56, 50.57, 50.58, 50.81, 50.90, 50.91, 50.92, 50.100, 50.101, 50.102, 50.103, 50.109, 50.110, 50.111.
(a)
(b)
(i) Non-licensed operator.
(ii) Shift supervisor.
(iii) Shift technical advisor.
(iv) Instrument and control technician.
(v) Electrical maintenance personnel.
(vi) Mechanical maintenance personnel.
(vii) Radiological protection technician.
(viii) Chemistry technician.
(ix) Engineering support personnel.
(2) The training program must incorporate the instructional requirements necessary to provide qualified personnel to operate and maintain the facility in a safe manner in all modes of operation. The training program must be developed so as to be in compliance with the facility license, including all technical specifications and applicable regulations. The training program must be periodically evaluated and revised as appropriate to reflect industry experience as well as changes to the facility, procedures, regulations, and quality assurance requirements. The training program must be periodically reviewed by licensee management for effectiveness. Sufficient records must be maintained by the licensee to maintain program integrity and kept available for NRC inspection to verify the adequacy of the program.
Pursuant to the provisions of § 50.34, an application for a construction permit must include the principal design criteria for a proposed facility. The principal design criteria establish the necessary design, fabrication, construction, testing, and performance requirements for structures, systems, and components important to safety; that is, structures, systems, and components that provide reasonable assurance that the facility can be operated without undue risk to the health and safety of the public.
These General Design Criteria establish minimum requirements for the principal design criteria for water-cooled nuclear power plants similar in design and location to plants for which construction permits have been issued by the Commission. The General Design Criteria are also considered to be generally applicable to other types of nuclear power units and are intended to provide guidance in establishing the principal design criteria for such other units.
The development of these General Design Criteria is not yet complete. For example, some of the definitions need further amplification. Also, some of the specific design requirements for structures, systems, and components important to safety have not as yet been suitably defined. Their omission does not relieve any applicant from considering these matters in the design of a specific facility and satisfying the necessary safety requirements. These matters include:
(1) Consideration of the need to design against single failures of passive components in fluid systems important to safety. (See Definition of Single Failure.)
(2) Consideration of redundancy and diversity requirements for fluid systems important to safety. A “system” could consist of a number of subsystems each of which is separately capable of performing the specified system safety function. The minimum acceptable redundancy and diversity of subsystems and components within a subsystem, and the required interconnection and independence of the subsystems have not yet been developed or defined. (See Criteria 34, 35, 38, 41, and 44.)
(3) Consideration of the type, size, and orientation of possible breaks in components of the reactor coolant pressure boundary in determining design requirements to suitably protect against postulated loss-of-coolant accidents. (See Definition of Loss of Coolant Accidents.)
(4) Consideration of the possibility of systematic, nonrandom, concurrent failures of
It is expected that the criteria will be augmented and changed from time to time as important new requirements for these and other features are developed.
There will be some water-cooled nuclear power plants for which the General Design Criteria are not sufficient and for which additional criteria must be identified and satisfied in the interest of public safety. In particular, it is expected that additional or different criteria will be needed to take into account unusual sites and environmental conditions, and for water-cooled nuclear power units of advanced design. Also, there may be water-cooled nuclear power units for which fulfillment of some of the General Design Criteria may not be necessary or appropriate. For plants such as these, departures from the General Design Criteria must be identified and justified.
The onsite electric power supplies, including the batteries, and the onsite electric distribution system, shall have sufficient independence, redundancy, and testability to perform their safety functions assuming a single failure.
Electric power from the transmission network to the onsite electric distribution system shall be supplied by two physically independent circuits (not necessarily on separate rights of way) designed and located so as to minimize to the extent practical the likelihood of their simultaneous failure under operating and postulated accident and environmental conditions. A switchyard common to both circuits is acceptable. Each of these circuits shall be designed to be available in sufficient time following a loss of all onsite alternating current power supplies and the other offsite electric power circuit, to assure that specified acceptable fuel design limits and design conditions of the reactor coolant pressure boundary are not exceeded. One of these circuits shall be designed to be available within a few seconds following a loss-of-coolant accident to assure that core cooling, containment integrity, and other vital safety functions are maintained.
Provisions shall be included to minimize the probability of losing electric power from any of the remaining supplies as a result of, or coincident with, the loss of power generated by the nuclear power unit, the loss of power from the transmission network, or the loss of power from the onsite electric power supplies.
Applicants for and holders of construction permits and operating licenses under this part who apply on or after January 10, 1997, applicants for design certifications under part 52 of this chapter who apply on or after January 10, 1997, applicants for and holders of combined licenses under part 52 of this chapter who do not reference a standard design certification, or holders of operating licenses using an alternative source term under § 50.67, shall meet the requirements of this criterion, except that with regard to control room access and occupancy, adequate radiation protection shall be provided to ensure that radiation exposures shall not exceed 0.05 Sv (5 rem) total effective dose equivalent (TEDE) as defined in § 50.2 for the duration of the accident.
Suitable redundancy in components and features, and suitable interconnections, leak detection, and isolation capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
Suitable redundancy in components and features, and suitable interconnections, leak detection, isolation, and containment capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
Suitable redundancy in components and features, and suitable interconnections, leak detection, isolation, and containment capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
Each system shall have suitable redundancy in components and features, and suitable interconnections, leak detection, isolation, and containment capabilities to assure
Suitable redundancy in components and features, and suitable interconnections, leak detection, and isolation capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
(1) One locked closed isolation valve inside and one locked closed isolation valve outside containment; or
(2) One automatic isolation valve inside and one locked closed isolation valve outside containment; or
(3) One locked closed isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment; or
(4) One automatic isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment.
Other appropriate requirements to minimize the probability or consequences of an accidental rupture of these lines or of lines connected to them shall be provided as necessary to assure adequate safety. Determination of the appropriateness of these requirements, such as higher quality in design, fabrication, and testing, additional provisions for inservice inspection, protection against more severe natural phenomena, and additional isolation valves and containment, shall include consideration of the population density, use characteristics, and physical characteristics of the site environs.
(1) One locked closed isolation valve inside and one locked closed isolation valve outside containment; or
(2) One automatic isolation valve inside and one locked closed isolation valve outside containment; or
(3) One locked closed isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment; or
(4) One automatic isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment.
As used in this appendix, “quality assurance” comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to the physical characteristics of a material, structure, component, or system which provide a means to control the quality of the material, structure, component, or system to predetermined requirements.
The applicant
The applicant shall establish at the earliest practicable time, consistent with the schedule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix. This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions. The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations participating in the program, together with the designated functions of these organizations. The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety. Activities affecting quality shall be accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanness; and assurance that all prerequisites for the given activity have been satisfied. The program shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test. The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained. The applicant shall regularly review the status and adequacy of the quality assurance program. Management of other organizations participating in the quality assurance program shall regularly review the status and adequacy of that part of the quality assurance program which they are executing.
Measures shall be established to assure that applicable regulatory requirements and the design basis, as defined in § 50.2 and as specified in the license application, for those structures, systems, and components to which this appendix applies are correctly translated into specifications, drawings, procedures, and instructions. These measures shall include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled. Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components.
Measures shall be established for the identification and control of design interfaces and for coordination among participating design organizations. These measures shall include the establishment of procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces.
The design control measures shall provide for verifying or checking the adequacy of design, such as by the performance of design reviews, by the use of alternate or simplified calculational methods, or by the performance of a suitable testing program. The verifying or checking process shall be performed by individuals or groups other than those who performed the original design, but who may be from the same organization. Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking processes, it shall include suitable qualifications testing of a prototype unit under the most adverse design conditions. Design control measures shall be applied to items such as the following: reactor physics, stress, thermal, hydraulic, and accident analyses; compatibility of materials; accessibility for inservice inspection, maintenance, and repair; and delineation of acceptance criteria for inspections and tests.
Design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design and be approved by the organization that performed the original design unless the applicant designates another responsible organization.
Measures shall be established to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its contractors or subcontractors. To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent with the pertinent provisions of this appendix.
Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings. Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
Measures shall be established to control the issuance of documents, such as instructions, procedures, and drawings, including changes thereto, which prescribe all activities affecting quality. These measures shall assure that documents, including changes, are reviewed for adequacy and approved for release by authorized personnel and are distributed to and used at the location where the prescribed activity is performed. Changes to documents shall be reviewed and approved by the same organizations that performed the original review and approval unless the applicant designates another responsible organization.
Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. Documentary evidence that material and equipment conform to the procurement requirements shall be available at the nuclear power plant or fuel reprocessing plant site prior to installation or use of such material and equipment. This documentary evidence shall be retained at the nuclear power plant or fuel reprocessing plant site and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and equipment. The effectiveness of the control of quality by contractors and subcontractors shall be assessed by the applicant or designee at intervals consistent with the importance, complexity, and quantity of the product or services.
Measures shall be established for the identification and control of materials, parts, and components, including partially fabricated assemblies. These measures shall assure that identification of the item is maintained by heat number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, erection, installation, and use of the item. These identification and control measures shall be designed to prevent the use of incorrect or defective material, parts, and components.
Measures shall be established to assure that special processes, including welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.
A program for inspection of activities affecting quality shall be established and executed by or for the organization performing the activity to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity. Such inspection shall be performed by individuals other than those who performed the activity being inspected. Examinations, measurements, or tests of material or products processed shall be performed for each work operation where necessary to assure quality. If inspection of processed material or products is impossible or disadvantageous, indirect control by monitoring processing methods, equipment, and personnel shall be provided. Both inspection and process monitoring shall be provided when control is inadequate without both. If mandatory inspection hold points, which require witnessing or inspecting by the applicant's designated representative and beyond which work shall not proceed without the consent of its designated representative are required, the specific hold points shall be indicated in appropriate documents.
A test program shall be established to assure that all testing required to demonstrate that structures, systems, and components will perform satisfactorily in service is identified and performed in accordance with written test procedures which incorporate the requirements and acceptance limits contained in applicable design documents. The test program shall include, as appropriate, proof tests prior to installation, preoperational tests, and operational tests during nuclear power plant or fuel reprocessing plant operation, of structures, systems,
Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.
Measures shall be established to control the handling, storage, shipping, cleaning and preservation of material and equipment in accordance with work and inspection instructions to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, specific moisture content levels, and temperature levels, shall be specified and provided.
Measures shall be established to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the nuclear power plant or fuel reprocessing plant. These measures shall provide for the identification of items which have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypassing of such inspections and tests. Measures shall also be established for indicating the operating status of structures, systems, and components of the nuclear power plant or fuel reprocessing plant, such as by tagging valves and switches, to prevent inadvertent operation.
Measures shall be established to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation. These measures shall include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures.
Measures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected. In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.
Sufficient records shall be maintained to furnish evidence of activities affecting quality. The records shall include at least the following: Operating logs and the results of reviews, inspections, tests, audits, monitoring of work performance, and materials analyses. The records shall also include closely-related data such as qualifications of personnel, procedures, and equipment. Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. Records shall be identifiable and retrievable. Consistent with applicable regulatory requirements, the applicant shall establish requirements concerning record retention, such as duration, location, and assigned responsibility.
A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or check lists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audit results shall be documented and reviewed by management having responsibility in the area audited. Followup action, including reaudit of deficient areas, shall be taken where indicated.
This appendix is intended to apprise applicants for licenses to construct production or utilization facilities of the types described in § 50.21(b) or § 50.22, or testing facilities, of the general kinds of financial data and other related information that will demonstrate the financial qualification of the applicant to carry out the activities for which the permit is sought. The kind and depth of information described in this guide is not intended to be a rigid and absolute requirement. In some instances, additional pertinent material may be needed. In any case, the applicant should include information other than that specified, if such information is pertinent to establishing the applicant's financial ability to construct the proposed facility.
It is important to observe also that both § 50.33(f) and this appendix distinguish between applicants which are established organizations and those which are newly-formed entities organized primarily for the purpose of engaging in the activity for which the permit is sought. Those in the former category will normally have a history of operating experience and be able to submit financial statements reflecting the financial results of past operations. With respect, however, to the applicant which is a newly formed company established primarily for the purpose of carrying out the licensed activity, with little or no prior operating history, somewhat more detailed data and supporting documentation will generally be necessary. For this reason, the appendix describes separately the scope of information to be included in applications by each of these two classes of applicants.
In determining an applicant's financial qualification, the Commission will require the minimum amount of information necessary for that purpose. No special forms are prescribed for submitting the information. In many cases, the financial information usually contained in current annual financial reports, including summary data of prior years, will be sufficient for the Commission's needs. The Commission reserves the right, however, to require additional financial information at the construction permit stage, particularly in cases in which the proposed power generating facility will be commonly owned by two or more existing companies or in which financing depends upon long-term arrangements for sharing of the power from the facility by two or more electrical generating companies.
Applicants are encouraged to consult with the Commission with respect to any questions they may have relating to the requirements of the Commission's regulations or the information set forth in this appendix.
1.
Since the composition of construction cost estimates for production and utilization facilities other than nuclear power reactors will vary according to the type of facility, no particular format is suggested for submitting such estimates. The estimate should, however, be itemized by categories of cost in sufficient detail to permit an evaluation of its reasonableness.
2.
3.
1.
2.
Each holder of a construction permit for a production or utilization facility of a type described in § 50.21(b) or § 50.22, or a testing facility is required by § 50.71(b) to file its annual financial report with the Commission at the time of issuance thereof. This requirement does not apply to licensees or holders of construction permits for medical and research reactors.
The Commission may, from time to time, request the applicant, whether an established organization or newly formed entity, to submit additional or more detailed information respecting its financial arrangements and status of funds if such information is deemed necessary to enable the Commiasion to determine an applicant's financial qualifications for the license.
Each applicant for a construction permit is required by § 50.34(a) to include in the preliminary safety analysis report a discussion of preliminary plans for coping with emergencies. Each applicant for an operating license is required by § 50.34(b) to include in the final safety analysis report plans for coping with emergencies.
This appendix establishes minimum requirements for emergency plans for use in attaining an acceptable state of emergency preparedness. These plans shall be described generally in the preliminary safety analysis report and submitted as part of the final safety analysis report.
The potential radiological hazards to the public associated with the operation of research and test reactors and fuel facilities licensed under 10 CFR parts 50 and 70 involve considerations different than those associated with nuclear power reactors. Consequently, the size of Emergency Planning Zones
Notwithstanding the above paragraphs, in the case of an operating license authorizing only fuel loading and/or low power operations up to 5% of rated power, no NRC or FEMA review, findings, or determinations concerning the state of offsite emergency preparedness or the adequacy of and the capability to implement State and local offsite emergency plans, as defined in this appendix, are required prior to the issuance of such a license.
The Preliminary Safety Analysis Report shall contain sufficient information to ensure the compatibility of proposed emergency plans for both onsite areas and the EPZs, with facility design features, site layout, and site location with respect to such considerations as access routes, surrounding population distributions, land use, and local jurisdictional boundaries for the EPZs in the case of nuclear power reactors as well as the means by which the standards of § 50.47(b) will be met.
As a minimum, the following items shall be described:
A. Onsite and offsite organizations for coping with emergencies and the means for notification, in the event of an emergency, of persons assigned to the emergency organizations.
B. Contacts and arrangements made and documented with local, State, and Federal governmental agencies with responsibility for coping with emergencies, including identification of the principal agencies.
C. Protective measures to be taken within the site boundary and within each EPZ to protect health and safety in the event of an accident; procedures by which these measures are to be carried out (e.g., in the case of an evacuation, who authorizes the evacuation, how the public is to be notified and instructed, how the evacuation is to be carried out); and the expected response of offsite agencies in the event of an emergency.
D. Features of the facility to be provided for onsite emergency first aid and decontamination and for emergency transportation of onsite individuals to offsite treatment facilities.
E. Provisions to be made for emergency treatment at offsite facilities of individuals injured as a result of licensed activities.
F. Provisions for a training program for employees of the licensee, including those who are assigned specific authority and responsibility in the event of an emergency, and for other persons who are not employees of the licensee but whose assistance may be needed in the event of a radiological emergency.
G. A preliminary analysis that projects the time and means to be employed in the notification of State and local governments and the public in the event of an emergency. A nuclear power plant applicant shall perform a preliminary analysis of the time required to evacuate various sectors and distances within the plume exposure pathway EPZ for transient and permanent populations, noting major impediments to the evacuation or taking of protective actions.
H. A preliminary analysis reflecting the need to include facilities, systems, and methods for identifying the degree of seriousness and potential scope of radiological consequences of emergency situations within and outside the site boundary, including capabilities for dose projection using real-time meteorological information and for dispatch of radiological monitoring teams within the EPZs; and a preliminary analysis reflecting the role of the onsite technical support center and of the near-site emergency operations facility in assessing information, recommending protective action, and disseminating information to the public.
The Final Safety Analysis Report shall contain the plans for coping with emergencies. The plans shall be an expression of the overall concept of operation; they shall describe the essential elements of advance planning that have been considered and the provisions that have been made to cope with emergency situations. The plans shall incorporate information about the emergency response roles of supporting organizations and offsite agencies. That information shall be sufficient to provide assurance of coordination among the supporting groups and with the licensee.
The plans submitted must include a description of the elements set out in section IV for the Emergency Planning Zones (EPZs) to an extent sufficient to demonstrate that the plans provide reasonable assurance that adequate protective measures can and will be taken in the event of an emergency.
The applicant's emergency plans shall contain, but not necessarily be limited to, information needed to demonstrate compliance
The organization for coping with radiological emergencies shall be described, including definition of authorities, responsibilities, and duties of individuals assigned to the licensee's emergency organization and the means for notification of such individuals in the event of an emergency. Specifically, the following shall be included:
1. A description of the normal plant operating organization.
2. A description of the onsite emergency response organization with a detailed discussion of:
a. Authorities, responsibilities, and duties of the individual(s) who will take charge during an emergency;
b. Plant staff emergency assignments;
c. Authorities, responsibilities, and duties on an onsite emergency coordinator who shall be in charge of the exchange of information with offsite authorities responsible for coordinating and implementing offsite emergency measures.
3. A description, by position and function to be performed, of the licensee's headquarters personnel who will be sent to the plant site to augment the onsite emergency organization.
4. Identification, by position and function to be performed, of persons within the licensee organization who will be responsible for making offsite dose projections, and a description of how these projections will be made and the results transmitted to State and local authorities, NRC, and other appropriate governmental entities.
5. Identification, by position and function to be performed, of other employees of the licensee with special qualifications for coping with emergency conditions that may arise. Other persons with special qualifications, such as consultants, who are not employees of the licensee and who may be called upon for assistance for emergencies shall also be identified. The special qualifications of these persons shall be described.
6. A description of the local offsite services to be provided in support of the licensee's emergency organization.
7. Identification of, and assistance expected from, appropriate State, local, and Federal agencies with responsibilities for coping with emergencies.
8. Identification of the State and/or local officials responsible for planning for, ordering, and controlling appropriate protective actions, including evacuations when necessary.
The means to be used for determining the magnitude of and for continually assessing the impact of the release of radioactive materials shall be described, including emergency action levels that are to be used as criteria for determining the need for notification and participation of local and State agencies, the Commission, and other Federal agencies, and the emergency action levels that are to be used for determining when and what type of protective measures should be considered within and outside the site boundary to protect health and safety. The emergency action levels shall be based on in-plant conditions and instrumentation in addition to onsite and offsite monitoring. These emergency action levels shall be discussed and agreed on by the applicant and State and local governmental authorities and approved by NRC. They shall also be reviewed with the State and local governmental authorities on an annual basis.
The entire spectrum of emergency conditions that involve the alerting or activating of progressively larger segments of the total emergency organization shall be described. The communication steps to be taken to alert or activate emergency personnel under each class of emergency shall be described. Emergency action levels (based not only on onsite and offsite radiation monitoring information but also on readings from a number of sensors that indicate a potential emergency, such as the pressure in containment and the response of the Emergency Core Cooling System) for notification of offsite agencies shall be described. The existence, but not the details, of a message authentication scheme shall be noted for such agencies. The emergency classes defined shall include: (1) notification of unusual events, (2) alert, (3) site area emergency, and (4) general emergency. These classes are further discussed in NUREG-0654; FEMA-REP-1.
1. Administrative and physical means for notifying local, State, and Federal officials
2. Provisions shall be described for yearly dissemination to the public within the plume exposure pathway EPZ of basic emergency planning information, such as the methods and times required for public notification and the protective actions planned if an accident occurs, general information as to the nature and effects of radiation, and a listing of local broadcast stations that will be used for dissemination of information during an emergency. Signs or other measures shall also be used to disseminate to any transient population within the plume exposure pathway EPZ appropriate information that would be helpful if an accident occurs.
3. A licensee shall have the capability to notify responsible State and local governmental agencies within 15 minutes after declaring an emergency. The licensee shall demonstrate that the State/local officials have the capability to make a public notification decision promptly on being informed by the licensee of an emergency condition. By February 1, 1982, each nuclear power reactor licensee shall demonstrate that administrative and physical means have been established for alerting and providing prompt instructions to the public within the plume exposure pathway EPZ. The four-month period in 10 CFR 50.54(s)(2) for the correction of emergency plan deficiencies shall not apply to the initial installation of this public notification system that is required by February 1, 1982. The four-month period will apply to correction of deficiencies identified during the initial installation and testing of the prompt public notification systems as well as those deficiencies discovered thereafter. The design objective of the prompt public notification system shall be to have the capability to essentially complete the initial notification of the public within the plume exposure pathway EPZ within about 15 minutes. The use of this notification capability will range from immediate notification of the public (within 15 minutes of the time that State and local officials are notified that a situation exists requiring urgent action) to the more likely events where there is substantial time available for the State and local governmental officials to make a judgment whether or not to activate the public notification system. Where there is a decision to activate the notification system, the State and local officials will determine whether to activate the entire notification system simultaneously or in a graduated or staged manner. The responsibility for activating such a public notification system shall remain with the appropriate governmental authorities.
Adequate provisions shall be made and described for emergency facilities and equipment, including:
1. Equipment at the site for personnel monitoring;
2. Equipment for determining the magnitude of and for continuously assessing the impact of the release of radioactive materials to the environment;
3. Facilities and supplies at the site for decontamination of onsite individuals;
4. Facilities and medical supplies at the site for appropriate emergency first aid treatment;
5. Arrangements for the services of physicians and other medical personnel qualified to handle radiation emergencies on-site;
6. Arrangements for transportation of contaminated injured individuals from the site to specifically identified treatment facilities outside the site boundary;
7. Arrangements for treatment of individuals injured in support of licensed activities on the site at treatment facilities outside the site boundary;
8. A licensee onsite technical support center and a licensee near-site emergency operations facility from which effective direction can be given and effective control can be exercised during an emergency;
9. At least one onsite and one offsite communications system; each system shall have a backup power source.
All communication plans shall have arrangements for emergencies, including titles and alternates for those in charge at both ends of the communication links and the primary and backup means of communication. Where consistent with the function of the governmental agency, these arrangements will include:
a. Provision for communications with contiguous State/local governments within the plume exposure pathway EPZ. Such communications shall be tested monthly.
b. Provision for communications with Federal emergency response organizations. Such communications systems shall be tested annually.
c. Provision for communications among the nuclear power reactor control room, the onsite technical support center, and the near-site emergency operations facility; and among the nuclear facility, the principal State and local emergency operations centers, and the field assessment teams. Such communications systems shall be tested annually.
d. Provisions for communications by the licensee with NRC Headquarters and the appropriate NRC Regional Office Operations Center from the nuclear power reactor control room, the onsite technical support center, and the near-site emergency operations facility. Such communications shall be tested monthly.
1. The program to provide for: (a) The training of employees and exercising, by periodic drills, of radiation emergency plans to ensure that employees of the licensee are familiar with their specific emergency response duties, and (b) The participation in the training and drills by other persons whose assistance may be needed in the event of a radiation emergency shall be described. This shall include a description of specialized initial training and periodic retraining programs to be provided to each of the following categories of emergency personnel:
i. Directors and/or coordinators of the plant emergency organization;
ii. Personnel responsible for accident assessment, including control room shift personnel;
iii Radiological monitoring teams;
iv. Fire control teams (fire brigades);
v. Repair and damage control teams;
vi. First aid and rescue teams;
vii. Medical support personnel;
viii. Licensee's headquarters support personnel;
ix. Security personnel.
In addition, a radiological orientation training program shall be made available to local services personnel; e.g., local emergency services/Civil Defense, local law enforcement personnel, local news media persons.
2. The plan shall describe provisions for the conduct of emergency preparedness exercises as follows: Exercises shall test the adequacy of timing and content of implementing procedures and methods, test emergency equipment and communications networks, test the public notification system, and ensure that emergency organization personnel are familiar with their duties.
a. A full participation
b. Each licensee at each site shall conduct an exercise of its onsite emergency plan every 2 years. The exercise may be included in the full participation biennial exercise required by paragraph 2.c. of this section. In addition, the licensee shall take actions necessary to ensure that adequate emergency response capabilities are maintained during the interval between biennial exercises by conducting drills, including at least one drill involving a combination of some of the principal functional areas of the licensee's onsite emergency response capabilities. The principal functional areas of emergency response include activities such as management and coordination of emergency response, accident assessment, protective action decisionmaking, and plant system repair and corrective actions. During these drills, activation of all of the licensee's emergency response facilities (Technical Support Center (TSC), Operations Support Center (OSC), and the Emergency Operations Facility (EOF)) would not be necessary, licensees would have the opportunity to consider accident management strategies, supervised instruction would be permitted, operating staff would have the opportunity to resolve problems (success paths) rather than have controllers intervene, and the drills could focus on onsite training objectives.
c. Offsite plans for each site shall be exercised biennially with full participation by each offsite authority having a role under the plan. Where the offsite authority has a role under a radiological response plan for more than one site, it shall fully participate in one exercise every two years and shall, at
d. A State should fully participate in the ingestion pathway portion of exercises at least once every six years. In States with more than one site, the State should rotate this participation from site to site.
e. Licensees shall enable any State or local Government located within the plume exposure pathway EPZ to participate in the licensee's drills when requested by such State or local Government.
f. Remedial exercises will be required if the emergency plan is not satisfactorily tested during the biennial exercise, such that NRC, in consultation with FEMA, cannot find reasonable assurance that adequate protective measures can be taken in the event of a radiological emergency. The extent of State and local participation in remedial exercises must be sufficient to show that appropriate corrective measures have been taken regarding the elements of the plan not properly tested in the previous exercises.
g. All training, including exercises, shall provide for formal critiques in order to identify weak or deficient areas that need correction. Any weaknesses or deficiencies that are identified shall be corrected.
h. The participation of State and local governments in an emergency exercise is not required to the extent that the applicant has identified those governments as refusing to participate further in emergency planning activities, pursuant to 10 CFR 50.47(c)(1). In such cases, an exercise shall be held with the applicant or licensee and such governmental entities as elect to participate in the emergency planning process.
Provisions to be employed to ensure that the emergency plan, its implementing procedures, and emergency equipment and supplies are maintained up to date shall be described.
Criteria to be used to determine when, following an accident, reentry of the facility would be appropriate or when operation could be resumed shall be described.
No less than 180 days prior to the scheduled issuance of an operating license for a nuclear power reactor or a license to possess nuclear material the applicant's detailed implementing procedures for its emergency plan shall be submitted to the Commission as specified in § 50.4. Licensees who are authorized to operate a nuclear power facility shall submit any changes to the emergency plan or procedures to the Commission, as specified in § 50.4, within 30 days of such changes.
1. The Emergency Response Data System (ERDS) is a direct near real-time electronic data link between the licensee's onsite computer system and the NRC Operations Center that provides for the automated transmission of a limited data set of selected parameters. The ERDS supplements the existing voice transmission over the Emergency Notification System (ENS) by providing the NRC Operations Center with timely and accurate updates of a limited set of parameters from the licensee's installed onsite computer system in the event of an emergency. When selected plant data are not available on the licensee's onsite computer system, retrofitting of data points is not required. The licensee shall test the ERDS periodically to verify system availability and operability. The frequency of ERDS testing will be quarterly unless otherwise set by NRC based on demonstrated system performance.
2. Except for Big Rock Point and all nuclear power facilities that are shut down permanently or indefinitely, onsite hardware shall be provided at each unit by the licensee to interface with the NRC receiving system. Software, which will be made available by the NRC, will assemble the data to be transmitted and transmit data from each unit via an output port on the appropriate data system. The hardware and software must have the following characteristics:
a. Data points, if resident in the in-plant computer systems, must be transmitted for four selected types of plant conditions: Reactor core and coolant system conditions; reactor containment conditions; radioactivity release rates; and plant meteorological tower data. A separate data feed is required for each reactor unit. While it is recognized that ERDS is not a safety system, it is conceivable that a licensee's ERDS interface could communicate with a safety system. In this case, appropriate isolation devices would be required at these interfaces.
(i) For pressurized water reactors (PWRs), the selected plant parameters are: (1) Primary coolant system: pressure, temperatures
(ii) For boiling water reactors (BWRs), the selected parameters are: (1) Reactor coolant system: Reactor pressure, reactor vessel level, feedwater flow, and reactor power; (2) Safety injection: Reactor core isolation cooling flow, high-pressure coolant injection/high-pressure core spray flow, core spray flow, low-pressure coolant injection flow, and condensate storage tank level; (3) Containment: drywell pressure, drywell temperatures, drywell sump levels, hydrogen and oxygen concentrations, suppression pool temperature, and suppression pool level; (4) Radiation monitoring system: Reactor coolant radioactivity level, primary containment radiation level, condenser off-gas radiation level, effluent radiation monitor, and process radiation levels; and (5) Meteorological data: Wind speed, wind direction, and atmospheric stability.
b. The system must be capable of transmitting all available ERDS parameters at time intervals of not less than 15 seconds or more than 60 seconds. Exceptions to this requirement will be considered on a case by case basis.
c. All link control and data transmission must be established in a format compatible with the NRC receiving system
3. Maintaining Emergency Response Data System:
a. Any hardware and software changes that affect the transmitted data points identified in the ERDS Data Point Library
b. Hardware and software changes, with the exception of data point modifications, that could affect the transmission format and computer communication protocol to the ERDS must be provided to the NRC as soon as practicable and at least 30 days prior to the modification.
c. In the event of a failure of the NRC supplied onsite modem, a replacement unit will be furnished by the NRC for licensee installation.
4. Implementing the Emergency Response Data System Program:
a. Each licensee shall develop and submit an ERDS implementation program plan to the NRC by October 28, 1991. To ensure compatibility with the guidance provided for the ERDS, the ERDS implementation program plan,
b. Licensees must comply with appendix E to part 50, section V.
c. Licensees that have submitted the required information under the voluntary ERDS implementation program will not be required to resubmit this information. The licensee shall meet the implementation schedule of appendix E to part 50, section VI.4d.
d. Each licensee shall complete implementation of the ERDS by February 13, 1993, or before initial escalation to full power, whichever comes later. Licensees with currently operational ERDS interfaces approved under the voluntary ERDS implementation program
1. Public health and safety considerations relating to licensed fuel reprocessing plants do not require that such facilities be located on land owned and controlled by the Federal Government. Such plants, including the facilities for the temporary storage of highlevel radioactive wastes, may be located on privately owned property.
2. A fuel reprocessing plant's inventory of high-level liquid radioactive wastes will be
3. Disposal of high-level radioactive fission product waste material will not be permitted on any land other than that owned and controlled by the Federal Government.
4. A design objective for fuel reprocessing plants shall be to facilitate decontamination and removal of all significant radioactive wastes at the time the facility is permanently decommissioned. Criteria for the extent of decontamination to be required upon decommissioning and license termination will be developed in consultation with competent groups. Opportunity will be afforded for public comment before such criteria are made effective.
5. Applicants proposing to operate fuel reprocessing plants, in submitting information concerning financial qualifications as required by § 50.33(f), shall include information enabling the Commission to determine whether the applicant is financially qualified, among other things, to provide for the removal and disposal of radioactive wastes, during operation and upon decommissioning of the facility, in accordance with the Commission's regulations, including the requirements set out in this appendix.
6. With respect to fuel reprocessing plants already licensed, the licenses will be appropriately conditioned to carry out the purposes of the policy stated above with respect to high-level radioactive fission product wastes generated after installation of new equipment for interim storage of liquid wastes, or after installation of equipment required for solidification without interim liquid storage. In either case, such equipment shall be installed at the earliest practicable date, taking into account the time required for design, procurement and installation thereof. With respect to such plants, the application of the policy stated in this appendix to existing wastes and to wastes generated prior to the installation of such equipment, will be the subject of a further rulemaking proceeding.
This appendix specifies fracture toughness requirements for ferritic materials of pressure-retaining components of the reactor coolant pressure boundary of light water nuclear power reactors to provide adequate margins of safety during any condition of normal operation, including anticipated operational occurrences and system hydrostatic tests, to which the pressure boundary may be subjected over its service lifetime.
The ASME Code forms the basis for the requirements of this appendix. “ASME Code” means the American Society of Mechanical Engineers Boiler and Pressure Vessel Code. If no section is specified, the reference is to Section III, Division 1, “Rules for Construction of Nuclear Power Plant Components.” “Section XI” means Section XI, Division 1, “Rules for Inservice Inspection of Nuclear Power Plant Components.” If no edition or addenda are specified, the ASME Code edition and addenda and any limitations and modifications thereof, which are specified in § 50.55a, are applicable.
The sections, editions and addenda of the ASME Boiler and Pressure Vessel Code specified in § 50.55a have been approved for incorporation by reference by the Director of the Federal Register. A notice of any changes
The requirements of this appendix apply to the following materials:
A. Carbon and low-alloy ferritic steel plate, forgings, castings, and pipe with specified minimum yield strengths not over 50,000 psi (345 MPa), and to those with specified minimum yield strengths greater than 50,000 psi (345 MPa) but not over 90,000 psi (621 MPa) if qualified by using methods equivalent to those described in paragraph G-2110 of appendix G of section XI of the latest edition and addenda of the ASME Code incorporated by reference into § 50.55a(b)(2).
B. Welds and weld heat-affected zones in the materials specified in paragraph I.A. of this appendix.
C. Materials for bolting and other types of fasteners with specified minimum yield strengths not over 130,000 psi (896 MPa).
The adequacy of the fracture toughness of other ferritic materials not covered in this section must be demonstrated to the Director, Office of Nuclear Reactor Regulation, on an individual case basis.
A.
B.
C.
D.
(i) For the pre-service or unirradiated condition, RT
(ii) For the reactor vessel beltline materials, RT
E. Δ
F.
A. To demonstrate compliance with the fracture toughness requirements of section IV of this appendix, ferritic materials must be tested in accordance with the ASME Code and, for the beltline materials, the test requirements of appendix H of this part. For a reactor vessel that was constructed to an ASME Code earlier than the Summer 1972 Addenda of the 1971 Edition (under § 50.55a), the fracture toughness data and data analyses must be supplemented in a manner approved by the Director, Office of Nuclear Reactor Regulation, to demonstrate equivalence with the fracture toughness requirements of this appendix.
B. Test methods for supplemental fracture toughness tests described in paragraph IV.A.1.b of this appendix must be submitted to and approved by the Director, Office of Nuclear Reactor Regulation, prior to testing.
C. All fracture toughness test programs conducted in accordance with paragraphs III.A and III.B must comply with ASME Code requirements for calibration of test equipment, qualification of test personnel, and retention of records of these functions and of the test data.
A. The pressure-retaining components of the reactor coolant pressure boundary that are made of ferritic materials must meet the requirements of the ASME Code, supplemented by the additional requirements set forth below, for fracture toughness during system hydrostatic tests and any condition of normal operation, including anticipated operational occurrences. Reactor vessels may continue to be operated only for that service period within which the requirements of this section are satisfied. For the reactor vessel beltline materials, including welds, plates and forgings, the values of RT
a. Reactor vessel beltline materials must have Charpy upper-shelf energy,
b. Additional evidence of the fracture toughness of the beltline materials after exposure to neutron irradiation may be obtained from results of supplemental fracture toughness tests for use in the analysis specified in section IV.A.1.a.
c. The analysis for satisfying the requirements of section IV.A.1 of this appendix must be submitted, as specified in § 50.4, for review and approval on an individual case basis at least three years prior to the date when the predicted Charpy upper-shelf energy will no longer satisfy the requirements of section IV.A.1 of this appendix, or on a schedule approved by the Director, Office of Nuclear Reactor Regulation.
a. Pressure-temperature limits and minimum temperature requirements for the reactor vessel are given in table 3, and are defined by the operating condition (i.e., hydrostatic pressure and leak tests, or normal operation including anticipated operational occurrences), the vessel pressure, whether or not fuel is in the vessel, and whether the core is critical. In table 3, the vessel pressure is defined as a percentage of the preservice system hydrostatic test pressure. The appropriate requirements on both the pressure-temperature limits and the minimum permissible temperature must be met for all conditions.
b. The pressure-temperature limits identified as “ASME Appendix G limits” in table 3 require that the limits must be at least as conservative as limits obtained by following the methods of analysis and the margins of safety of Appendix G of Section XI of the ASME Code.
c. The minimum temperature requirements given in table 3 pertain to the controlling material, which is either the material in the closure flange or the material in the beltline region with the highest reference temperature. As specified in table 3, the minimum temperature requirements and the controlling material depend on the operating condition (i.e., hydrostatic pressure and leak tests, or normal operation including anticipated operational occurrences), the vessel pressure, whether fuel is in the vessel, and whether the core is critical. The metal temperature of the controlling material, in the region of the controlling material which has the least favorable combination of stress and temperature, must exceed the appropriate minimum temperature requirement for the condition and pressure of the vessel specified in table 1.
d. Pressure tests and leak tests of the reactor vessel that are required by Section XI of the ASME Code must be completed before the core is critical.
B. If the procedures of section IV.A. of this appendix do not indicate the existence of an equivalent safety margin, the reactor vessel beltline may be given a thermal annealing treatment to recover the fracture toughness of the material, subject to the requirements of § 50.66. The reactor vessel may continue to be operated only for that service period within which the predicted fracture toughness of the beltline region materials satisfies the requirements of section IV.A. of this appendix using the values of RT
The purpose of the material surveillance program required by this appendix is to monitor changes in the fracture toughness properties of ferritic materials in the reactor vessel beltline region of light water nuclear power reactors which result from exposure of these materials to neutron irradiation and the thermal environment. Under the program, fracture toughness test data are obtained from material specimens exposed in surveillance capsules, which are withdrawn periodically from the reactor vessel. These data will be used as described in section IV of appendix G to part 50.
ASTM E 185-73, -79, and -82, “Standard Practice for Conducting Surveillance Tests for Light-Water Cooled Nuclear Power Reactor Vessels,” which are referenced in the following paragraphs, have been approved for incorporation by reference by the Director of the Federal Register. Copies of ASTM E 185-73, -79, and -82, may be purchased from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 19103 and are available for inspection at the NRC Library, 11545 Rockville Pike, Two White Flint North, Rockville, MD 20852-2738.
All terms used in this appendix have the same meaning as in appendix G.
A. No material surveillance program is required for reactor vessels for which it can be conservatively demonstrated by analytical methods applied to experimental data and tests performed on comparable vessels, making appropriate allowances for all uncertainties in the measurements, that the peak neutron fluence at the end of the design life of the vessel will not exceed 10
B. Reactor vessels that do not meet the conditions of paragraph III.A of this appendix must have their beltline materials monitored by a surveillance program complying with ASTM E 185, as modified by this appendix.
1. The design of the surveillance program and the withdrawal schedule must meet the requirements of the edition of ASTM E 185 that is current on the issue date of the ASME Code to which the reactor vessel was purchased. Later editions of ASTM E 185 may be used, but including only those editions through 1982. For each capsule withdrawal, the test procedures and reporting requirements must meet the requirements of ASTM E 185-82 to the extent practicable for the configuration of the specimens in the capsule.
2. Surveillance specimen capsules must be located near the inside vessel wall in the beltline region so that the specimen irradiation history duplicates, to the extent practicable within the physical constraints of the system, the neutron spectrum, temperature history, and maximum neutron fluence experienced by the reactor vessel inner surface. If
3. A proposed withdrawal schedule must be submitted with a technical justification as specified in § 50.4. The proposed schedule must be approved prior to implementation.
C. Requirements for an Integrated Surveillance Program.
1. In an integrated surveillance program, the representative materials chosen for surveillance for a reactor are irradiated in one or more other reactors that have similar design and operating features. Integrated surveillance programs must be approved by the Director, Office of Nuclear Reactor Regulation, on a case-by-case basis. Criteria for approval include the following:
a. The reactor in which the materials will be irradiated and the reactor for which the materials are being irradiated must have sufficiently similar design and operating features to permit accurate comparisons of the predicted amount of radiation damage.
b. Each reactor must have an adequate dosimetry program.
c. There must be adequate arrangement for data sharing between plants.
d. There must be a contingency plan to assure that the surveillance program for each reactor will not be jeopardized by operation at reduced power level or by an extended outage of another reactor from which data are expected.
e. There must be substantial advantages to be gained, such as reduced power outages or reduced personnel exposure to radiation, as a direct result of not requiring surveillance capsules in all reactors in the set.
2. No reduction in the requirements for number of materials to be irradiated, specimen types, or number of specimens per reactor is permitted.
3. After (the effective date of this section), no reduction in the amount of testing is permitted unless previously authorized by the Director, Office of Nuclear Reactor Regulation.
A. Each capsule withdrawal and the test results must be the subject of a summary technical report to be submitted, as specified in § 50.4, within one year of the date of capsule withdrawal, unless an extension is granted by the Director, Office of Nuclear Reactor Regulation.
B. The report must include the data required by ASTM E 185, as specified in paragraph III.B.1 of this appendix, and the results of all fracture toughness tests conducted on the beltline materials in the irradiated and unirradiated conditions.
C. If a change in the Technical Specifications is required, either in the pressure-temperature limits or in the operating procedures required to meet the limits, the expected date for submittal of the revised Technical Specifications must be provided with the report.
SECTION I.
Section 50.36a contains provisions designed to assure that releases of radioactive material from nuclear power reactors to unrestricted areas during normal conditions, including expected occurrences, are kept as low as practicable.
A. The calculated annual total quantity of all radioactive material above background
B.1. The calculated annual total quantity of all radioactive material above background to be released from each light-water-cooled nuclear power reactor to the atmosphere will not result in an estimated annual air dose from gaseous effluents at any location near ground level which could be occupied by individuals in unrestricted areas in excess of 10 millirads for gamma radiation or 20 millirads for beta radiation.
2. Notwithstanding the guidance of paragraph B.1:
(a) The Commission may specify, as guidance on design objectives, a lower quantity of radioactive material above background to be released to the atmosphere if it appears that the use of the design objectives in paragraph B.1 is likely to result in an estimated annual external dose from gaseous effluents to any individual in an unrestricted area in excess of 5 millirems to the total body; and
(b) Design objectives based upon a higher quantity of radioactive material above background to be released to the atmosphere than the quantity specified in paragraph B.1 will be deemed to meet the requirements for keeping levels of radioactive material in gaseous effluents as low as is reasonably achievable if the applicant provides reasonable assurance that the proposed higher quantity will not result in an estimated annual external dose from gaseous effluents to any individual in unrestricted areas in excess of 5 millirems to the total body or 15 millirems to the skin.
C. The calculated annual total quantity of all radioactive iodine and radioactive material in particulate form above background to be released from each light-water-cooled nuclear power reactor in effluents to the atmosphere will not result in an estimated annual dose or dose commitment from such radioactive iodine and radioactive material in particulate form for any individual in an unrestricted area from all pathways of exposure in excess of 15 millirems to any organ.
D. In addition to the provisions of paragraphs A, B, and C above, the applicant shall include in the radwaste system all items of reasonably demonstrated technology that, when added to the system sequentially and in order of diminishing cost-benefit return, can for a favorable cost-benefit ratio effect reductions in dose to the population reasonably expected to be within 50 miles of the reactor. As an interim measure and until establishment and adoption of better values (or other appropriate criteria), the values $1000 per total body man-rem and $1000 per man-thyroid-rem (or such lesser values as may be demonstrated to be suitable in a particular case) shall be used in this cost-benefit analysis. The requirements of this paragraph D need not be complied with by persons who have filed applications for construction permits which were docketed on or after January 2, 1971, and prior to June 4, 1976, if the radwaste systems and equipment described in the preliminary or final safety analysis report and amendments thereto satisfy the Guides on Design Objectives for Light-Water-Cooled Nuclear Power Reactors proposed in the Concluding Statement of Position of the Regulatory Staff in Docket-RM-50-2 dated February 20, 1974, pp. 25-30, reproduced in the annex to this appendix I.
2. The characteristics attributed to a hypothetical receptor for the purpose of estimating internal dose commitment shall take into account reasonable deviations of individual habits from the average. The applicant may take account of any real phenomenon or factors actually affecting the estimate of radiation exposure, including the characteristics of the plant, modes of discharge of radioactive materials, physical processes tending to attenuate the quantity of radioactive material to which an individual would be exposed, and the effects of averaging exposures over times during which determining factors may fluctuate.
B. If the applicant determines design objectives with respect to radioactive iodine on the basis of existing conditions and if potential changes in land and water usage and food pathways could result in exposures in
1. The quantities of radioactive iodine actually released to the atmosphere and deposited relative to those estimated in the determination of design objectives;
2. Whether changes in land and water usage and food pathways which would result in individual exposures greater than originally estimated have occurred; and
3. The content of radioactive iodine and foods involved in the changes, if and when they occur.
SEC. IV.
Section 50.36a(b) provides that licensees shall be guided by certain considerations in establishing and implementing operating procedures specified in technical specifications that take into account the need for operating flexibility and at the same time assure that the licensee will exert his best effort to keep levels of radioactive material in effluents as low as is reasonably achievable. The guidance set forth below provides additional and more specific guidance to licensees in this respect.
Through the use of the guides set forth in this section it is expected that the annual release of radioactive material in effluents from light-water-cooled nuclear power reactors can generally be maintained within the levels set forth as numerical guides for design objectives in Section II.
At the same time, the licensee is permitted the flexibility of operations, compatible with considerations of health and safety, to assure that the public is provided a dependable source of power even under unusual conditions which may temporarily result in releases higher than numerical guides for design objectives but still within levels that assure that the average population exposure is equivalent to small fractions of doses from natural background radiation. It is expected that in using this operational flexibility under unusual conditions, the licensee will exert his best efforts to keep levels of radioactive material in effluents within the numerical guides for design objectives.
A. If the quantity of radioactive material actually released in effluents to unrestricted areas from a light-water-cooled nuclear power reactor during any calendar quarter is such that the resulting radiation exposure, calculated on the same basis as the respective design objective exposure, would exceed one-half the design objective annual exposure derived pursuant to Sections II and III, the licensee shall:
1. Make an investigation to identify the causes for such release rates;
2. Define and initiate a program of corrective action; and
3. Report these actions as specified in § 50.4, within 30 days from the end of the quarter during which the release occurred.
B. The licensee shall establish an appropriate surveillance and monitoring program to:
1. Provide data on quantities of radioactive material released in liquid and gaseous effluents to assure that the provisions of paragraph A of this section are met;
2. Provide data on measurable levels of radiation and radioactive materials in the environment to evaluate the relationship between quantities of radioactive material released in effluents and resultant radiation doses to individuals from principal pathways of exposure; and
3. Identify changes in the use of unrestricted areas (e.g., for agricultural purposes) to permit modifications in monitoring programs for evaluating doses to individuals from principal pathways of exposure.
C. If the data developed in the surveillance and monitoring program described in paragraph B of Section III or from other monitoring programs show that the relationship between the quantities of radioactive material released in liquid and gaseous effluents and the dose to individuals in unrestricted areas is significantly different from that assumed in the calculations used to determine design objectives pursuant to Sections II and III, the Commission may modify the quantities in the technical specifications defining the limiting conditions in a license to operate a light-water-cooled nuclear power reactor or a license whose holder has submitted a certification of permanent cessation of operations under § 50.82(a)(1).
B. For each light-water-cooled nuclear power reactor constructed pursuant to a permit for which application was filed prior to January 2, 1971, the holder of the permit or a license, authorizing operation of the reactor shall, within a period of twelve months from June 4, 1975, file with the Commission:
1. Such information as is necessary to evaluate the means employed for keeping levels of radioactivity in effluents to unrestricted areas as low as is reasonably achievable, including all such information as is required by § 50.34a (b) and (c) not already contained in his application; and
2. Plans and proposed technical specifications developed for the purpose of keeping releases of radioactive materials to unrestricted areas during normal reactor operations, including expected operational occurrences, as low as is reasonably achievable.
A. For radioactive material above background
1. The calculated annual total quantity of all radioactive material from all light-water-cooled nuclear power reactors at a site should not result in an annual dose or dose commitment to the total body or to any organ of an individual in an unrestricted area from all pathways of exposure in excess of 5 millirems; and
2. The calculated annual total quantity of radioactive material, except tritium and dissolved gases, should not exceed 5 curies for each light-water-cooled reactor at a site.
3. Notwithstanding the guidance in paragraph A.2, for a particular site, if an applicant for a permit to construct a light-water-cooled nuclear power reactor has proposed baseline in-plant control measures
a. The applicant submits, as specified in § 50.4, an evaluation of the potential for effects from long-term buildup on the environment in the vicinity of the site of radioactive material, with a radioactive half-life greater than one year, to be released; and
b. The provisions of paragraph A.1 are met.
B. For radioactive material above background in gaseous effluents the annual total quantity of radioactive material to be released to the atmosphere by all light-water-cooled nuclear power reactors at a site:
1. The calculated annual air dose due to gamma radiation at any location near ground level which could be occupied by individuals at or beyond the boundary of the site should not exceed 10 millirads; and
2. The calculated annual air dose due to beta radiation at any location near ground level which could be occupied by individuals at or beyond the boundary of the site should not exceed 20 millirads.
3. Notwithstanding the guidance in paragraphs B.1 and B.2, for a particular site:
a. The Commission may specify, as guidance on design objectives, a lower quantity of radioactive material above background in gaseous effluents to be released to the atmosphere if it appears that the use of the design objectives described in paragraphs B.1 and B.2 is likely to result in an annual dose to an individual in an unrestricted area in excess of 5 millirems to the total body or 15 millirems to the skin; or
b. Design objectives based on a higher quantity of radioactive material above background in gaseous effluents to be released to the atmosphere than the quantity specified in paragraphs B.1 and B.2 may be deemed to meet the requirements for keeping levels of radioactive material in gaseous effluents as low as practicable if the applicant provides reasonable assurance that the proposed higher quantity will not result in annual doses to an individual in an unrestricted area in excess of 5 millirems to the total body or 15 millirems to the skin.
C. For radioactive iodine and radioactive material in particulate form above background released to the atmosphere:
1. The calculated annual total quantity of all radioactive iodine and radioactive material in particulate form from all light-water-cooled nuclear power reactors at a site should not result in an annual dose or dose commitment to any organ of an individual in
2. The calculated annual total quantity of iodine-131 in gaseous effluents should not exceed 1 curie for each light-water-cooled nuclear power reactor at a site.
3. Notwithstanding the guidance in paragraphs C.1 and C.2 for a particular site, if an applicant for a permit to construct a light-water-cooled nuclear power reactor has proposed baseline in-plant control measures
This appendix includes two options, A and B, either of which can be chosen for meeting the requirements of this appendix.
I. Introduction.
II. Explanation of terms.
III. Leakage test requirements.
A. Type A test.
B. Type B test.
C. Type C test.
D. Periodic retest schedule.
IV. Special test requirements.
A. Containment modifications.
B. Multiple leakage-barrier containments.
V. Inspection and reporting of tests.
A. Containment inspection.
B. Repordkeeping of test results.
One of the conditions of all operating licenses for water-cooled power reactors as specified in § 50.54(o) is that primary reactor containments shall meet the containment leakage test requirements set forth in this appendix. These test requirements provide for preoperational and periodic verification by tests of the leak-tight integrity of the primary reactor containment, and systems and components which penetrate containment of water-cooled power reactors, and establish the acceptance criteria for such tests. The purposes of the tests are to assure that (a) leakage through the primary reactor containment and systems and components penetrating primary containment shall not exceed allowable leakage rate values as specified in the technical specifications or associated bases and (b) periodic surveillance of reactor containment penetrations and isolation valves is performed so that proper maintenance and repairs are made during the service life of the containment, and systems and components penetrating primary containment. These test requirements may also be used for guidance in establishing appropriate containment leakage test requirements in technical specifications or associated bases for other types of nuclear power reactors.
A. “Primary reactor containment” means the structure or vessel that encloses the components of the reactor coolant pressure boundary, as defined in § 50.2(v), and serves as an essentially leak-tight barrier against the uncontrolled release of radioactivity to the environment.
B. “Containment isolation valve” means any valve which is relied upon to perform a containment isolation function.
C. “Reactor containment leakage test program” includes the performance of Type A, Type B, and Type C tests, described in II.F, II.G, and II.H, respectively.
D. “Leakage rate” for test purposes is that leakage which occurs in a unit of time, stated as a percentage of weight of the original content of containment air at the leakage rate test pressure that escapes to the outside atmosphere during a 24-hour test period.
E. “Overall integrated leakage rate” means that leakage rate which obtains from a summation of leakage through all potential leakage paths including containment
F. “Type A Tests” means tests intended to measure the primary reactor containment overall integrated leakage rate (1) after the containment has been completed and is ready for operation, and (2) at periodic intervals thereafter.
G. “Type B Tests” means tests intended to detect local leaks and to measure leakage across each pressure-containing or leakage-limiting boundary for the following primary reactor containment penetrations:
1. Containment penetrations whose design incorporates resilient seals, gaskets, or sealant componds, piping penetrations fitted with expansion bellows, and electrical penetrations fitted with flexible metal seal assemblies.
2. Air lock door seals, including door operating mechanism penetrations which are part of the containment pressure boundary.
3. Doors with resilient seals or gaskets except for seal-welded doors.
4. Components other than those listed in II.G.1, II.G.2, or II.G.3 which must meet the acceptance criteria in III.B.3.
H. “Type C Tests” means tests intended to measure containment isolation valve leakage rates. The containment isolation valves included are those that:
1. Provide a direct connection between the inside and outside atmospheres of the primary reactor containment under normal operation, such as purge and ventilation, vacuum relief, and instrument valves;
2. Are required to close automatically upon receipt of a containment isolation signal in response to controls intended to effect containment isolation;
3. Are required to operate intermittently under postaccident conditions; and
4. Are in main steam and feedwater piping and other systems which penetrate containment of direct-cycle boiling water power reactors.
I. Pa (p.s.i.g.) means the calculated peak containment internal pressure related to the design basis accident and specified either in the technical specification or associated bases.
J. Pt (p.s.i.g.) means the containment vessel reduced test pressure selected to measure the integrated leakage rate during periodic Type A tests.
K. La (percent/24 hours) means the maximum allowable leakage rate at pressure Pa as specified for preoperational tests in the technical specifications or associated bases, and as specified for periodic tests in the operating license.
L. Ld (percent/24 hours) means the design leakage rate at pressure, Pa, as specified in the technical specifications or associated bases.
M. Lt (percent/24 hours) means the maximum allowable leakage rate at pressure Pt derived from the preoperational test data as specified in III.A.4.(a)(iii).
N. Lam, Ltm (percent/24 hours) means the total measured containment leakage rates at pressure Pa and Pt, respectively, obtained from testing the containment with components and systems in the state as close as practical to that which would exist under design basis accident conditions (e.g., vented, drained, flooded or pressurized).
O. “Acceptance criteria” means the standard against which test results are to be compared for establishing the functional acceptability of the containment as a leakage limiting boundary.
A program consisting of a schedule for conducting Type A, B, and C tests shall be developed for leak testing the primary reactor containment and related systems and components penetrating primary containment pressure boundary.
Upon completion of construction of the primary reactor containment, including installation of all portions of mechanical, fluid, electrical, and instrumentation systems penetrating the primary reactor containment pressure boundary, and prior to any reactor operating period, preoperational and periodic leakage rate tests, as applicable, shall be conducted in accordance with the following:
A.
(b) Closure of containment isolation valves for the Type A test shall be accomplished by normal operation and without any preliminary exercising or adjustments (e.g., no tightening of valve after closure by valve motor). Repairs of maloperating or leaking valves shall be made as necessary. Information on any valve closure malfunction or valve leakage that require corrective action before the test, shall be included in the summary report required by V.B.
(c) The containment test conditions shall stabilize for a period of about 4 hours prior to the start of a leakage rate test.
(d) Those portions of the fluid systems that are part of the reactor coolant pressure boundary and are open directly to the containment atmosphere under post-accident conditions and become an extension of the boundary of the containment shall be opened or vented to the containment atmosphere prior to and during the test. Portions of closed systems inside containment that penetrate containment and rupture as a result of a loss of coolant accident shall be vented to the containment atmosphere. All vented systems shall be drained of water or other fluids to the extent necessary to assure exposure of the system containment isolation valves to containment air test pressure and to assure they will be subjected to the post accident differential pressure. Systems that are required to maintain the plant in a safe condition during the test shall be operable in their normal mode, and need not be vented. Systems that are normally filled with water and operating under post-accident conditions, such as the containment heat removal system, need not be vented. However, the containment isolation valves in the systems defined in III.A.1.(d) shall be tested in accordance with III.C. The measured leakage rate from these tests shall be included in the summary report required by V.B.
2.
3.
(b) The accuracy of any Type A test shall be verified by a supplemental test. An acceptable method is described in Appendix C of ANSI N45.4-1972. The supplemental test method selected shall be conducted for sufficient duration to establish accurately the change in leakage rate between the Type A and supplemental test. Results from this supplemental test are acceptable provided the difference between the supplemental test data and the Type A test data is within 0.25 La (or 0.25 Lt). If results are not within 0.25 La (or 0.25 Lt), the reason shall be determined, corrective action taken, and a successful supplemental test performed.
(c) Test leakage rates shall be calculated using absolute values corrected for instrument error.
4.
(ii) A second test shall be performed at pressure Pa to measure a leakage rate Lam.
(iii) The leakage characteristics yielded by measurements Ltm and Lam shall establish the maximum allowable test leakage rate Lt of not more than La (Ltm/Lam). In the event Ltm/Lam is greater than 0.7, Lt shall be specified as equal to La (Pt/Pa).
(2)
(b)
(2)
5.
(2) Peak pressure tests shall be conducted at Pa.
(b)
(2)
6.
(b) If two consecutive periodic Type A tests fail to meet the applicable acceptance criteria in III.A.5(b), notwithstanding the periodic retest schedule of III.D., a Type A test shall be performed at each plant shutdown for refueling or approximately every 18 months, whichever occurs first, until two consecutive Type A tests meet the acceptance criteria in III.A.5(b), after which time the retest schedule specified in III.D. may be resumed.
B.
(a) Examination by halide leak-detection method (or by other equivalent test methods such as mass spectrometer) of a test chamber, pressurized with air, nitrogen, or pneumatic fluid specified in the technical specifications or associated bases and constructed as part of individual containment penetrations.
(b) Measurement of the rate of pressure loss of the test chamber of the containment penetration pressurized with air, nitrogen, or pneumatic fluid specified in the technical specifications or associated bases.
(c) Leakage surveillance by means of a permanently installed system with provisions for continuous or intermittent pressurization of individual or groups of containment penetrations and measurement of rate of pressure loss of air, nitrogen, or pneumatic fluid specified in the technical specification or associated bases through the leak paths.
2.
3.
(b) Leakage measurements obtained through component leakage surveillance systems (e.g., continuous pressurization of individual containment components) that maintains a pressure not less than Pa at individual test chambers of containment penetrations during normal reactor operation, are acceptable in lieu of Type B tests.
C.
2.
(b) Valves, which are sealed with fluid from a seal system shall be pressurized with that fluid to a pressure not less than 1.10 Pa.
3.
(a) Such valves have been demonstrated to have fluid leakage rates that do not exceed those specified in the technical specifications or associated bases, and
(b) The installed isolation valve seal-water system fluid inventory is sufficient to assure the sealing function for at least 30 days at a pressure of 1.10 Pa.
D.
(b) Permissible periods for testing. The performance of Type A tests shall be limited to periods when the plant facility is non-operational and secured in the shutdown condition under the administrative control and in accordance with the safety procedures defined in the license.
2.
(b)(i) Air locks shall be tested prior to initial fuel loading and at 6-month intervals thereafter at an internal pressure not less than P
(ii) Air locks opened during periods when containment integrity is not required by the plant's Technical Specifications shall be tested at the end of such periods at not less than P
(iii) Air locks opened during periods when containment integrity is required by the plant's Technical Specifications shall be tested within 3 days after being opened. For air lock doors opened more frequently than once every 3 days, the air lock shall be tested at least once every 3 days during the period of frequent openings. For air lock doors having testable seals, testing the seals fulfills the 3-day test requirements. In the event that the testing for this 3-day interval cannot be at P
(iv) The acceptance criteria for air lock testing shall be stated in the Technical Specifications.
3.
A.
B.
A.
B.
2. For each periodic test, leakage test results from Type A, B, and C tests shall be included in the summary report. The summary report shall contain an analysis and interpretation of the Type A test results and a summary analysis of periodic Type B and Type C tests that were performed since the last type A test. Leakage test results from type A, B, and C tests that failed to meet the acceptance criteria of III.A.5(b), III.B.3, and III.C.3, respectively, shall be included in a separate accompanying summary report that includes an analysis and interpretation of the test data, the least squares fit analysis of the test data, the instrumentation error analysis, and the structural conditions of the containment or components, if any, which contributed to the failure in meeting the acceptance criteria. Results and analyses of the supplemental verification test employed to demonstrate the validity of the leakage rate test measurements shall also be included.
One of the conditions required of all operating licenses for light-water-cooled power reactors as specified in § 50.54(o) is that primary reactor containments meet the leakage-rate test requirements in either Option A or B of this appendix. These test requirements ensure that (a) leakage through these containments or systems and components penetrating these containments does not exceed allowable leakage rates specified in the Technical Specifications and (b) integrity of the containment structure is maintained during its service life. Option B of this appendix identifies the performance-based requirements and criteria for preoperational and subsequent periodic leakage-rate testing.
Type A tests to measure the containment system overall integrated leakage rate must be conducted under conditions representing design basis loss-of-coolant accident containment peak pressure. A Type A test must be conducted (1) after the containment system has been completed and is ready for operation and (2) at a periodic interval based on the historical performance of the overall containment system as a barrier to fission product releases to reduce the risk from reactor accidents. A general visual inspection of the accessible interior and exterior surfaces of the containment system for structural deterioration which may affect the containment leak-tight integrity must be conducted prior to each test, and at a periodic interval between tests based on the performance of the containment system. The leakage rate must not exceed the allowable leakage rate (La) with margin, as specified in the Technical Specifications. The test results must be compared with previous results to examine the performance history of the overall containment system to limit leakage.
Type B pneumatic tests to detect and measure local leakage rates across pressure retaining, leakage-limiting boundaries, and Type C pneumatic tests to measure containment isolation valve leakage rates, must be conducted (1) prior to initial criticality, and (2) periodically thereafter at intervals based on the safety significance and historical performance of each boundary and isolation valve to ensure the integrity of the overall containment system as a barrier to fission product release to reduce the risk from reactor accidents. The performance-based testing program must contain a performance criterion for Type B and C tests, consideration of leakage-rate limits and factors that are indicative of or affect performance, when establishing test intervals, evaluations of performance of containment system components, and comparison to previous test results to examine the performance history of the overall containment system to limit leakage. The tests must demonstrate that the sum of the leakage rates at accident pressure of Type B tests, and pathway leakage rates from Type C tests, is less than the performance criterion (La) with margin, as specified in the Technical Specification.
The results of the preoperational and periodic Type A, B, and C tests must be documented to show that performance criteria for leakage have been met. The comparison to previous results of the performance of the overall containment system and of individual components within it must be documented to show that the test intervals established for the containment system and components within it are adequate. These records must be available for inspection at plant sites.
If the test results exceed the performance criteria (La) as defined in the plant Technical Specifications, those exceedances must be assessed for Emergency Notification System reporting under §§ 50.72 (b)(1)(ii) and § 50.72 (b)(2)(i), and for a Licensee Event Report under § 50.73 (a)(2)(ii).
The requirements in either or both Option B, III.A for Type A tests, and Option B, III.B for Type B and C tests, may be adopted on a voluntary basis by an operating nuclear power reactor licensee as specified in § 50.54 in substitution of the requirements for those tests contained in Option A of this appendix. If the requirements for tests in Option B, III.A or Option B, III.B are implemented, the recordkeeping requirements in Option B, IV for these tests must be substituted for the reporting requirements of these tests contained in Option A of this appendix.
1. Specific exemptions to Option A of this appendix that have been formally approved by the AEC or NRC, according to 10 CFR 50.12, are still applicable to Option B of this appendix if necessary, unless specifically revoked by the NRC.
2. A licensee or applicant for an operating license may adopt Option B, or parts thereof, as specified in Section V.A of this appendix, by submitting its implementation plan and request for revision to technical specifications (see paragraph B.3 below) to the Director of the Office of Nuclear Reactor Regulation.
3. The regulatory guide or other implementation document used by a licensee, or applicant for an operating license, to develop a performance-based leakage-testing program must be included, by general reference, in the plant technical specifications. The submittal for technical specification revisions must contain justification, including supporting analyses, if the licensee chooses to deviate from methods approved by the Commission and endorsed in a regulatory guide.
4. The detailed licensee programs for conducting testing under Option B must be available at the plant site for NRC inspection.
I. Required and Acceptable Features of Evaluation Models.
II. Required Documentation.
A.
1.
2.
3.
4.
5.
6.
7.
Each evaluation model shall include a provision for predicting cladding swelling and rupture from consideration of the axial temperature distribution of the cladding and from the difference in pressure between the inside and outside of the cladding, both as functions of time. To be acceptable the swelling and rupture calculations shall be based on applicable data in such a way that the degree of swelling and incidence of rupture are not underestimated. The degree of swelling and rupture shall be taken into account in calculations of gap conductance, cladding oxidation and embrittlement, and hydrogen generation.
The calculations of fuel and cladding temperatures as a function of time shall use values for gap conductance and other thermal parameters as functions of temperature and other applicable time-dependent variables. The gap conductance shall be varied in accordance with changes in gap dimensions and any other applicable variables.
1.
b.
c.
d.
2.
3.
4.
b. Steady-state CHF correlations acceptable for use in LOCA transients include, but are not limited to, the following:
(1)
(2)
(3)
(4)
(5)
(6)
c. Correlations of appropriate transient CHF data may be accepted for use in LOCA transient analyses if comparisons between the data and the correlations are provided to demonstrate that the correlations predict values of CHF which allow for uncertainty in the experimental data throughout the range of parameters for which the correlations are to be used. Where appropriate, the comparisons shall use statistical uncertainty analysis of the data to demonstrate the conservatism of the transient correlation.
d. Transient CHF correlations acceptable for use in LOCA transients include, but are not limited to, the following:
(1)
e. After CHF is first predicted at an axial fuel rod location during blowdown, the calculation shall not use nucleate boiling heat transfer correlations at that location subsequently during the blowdown even if the calculated local fluid and surface conditions would apparently justify the reestablishment of nucleate boiling. Heat transfer assumptions characteristic of return to nucleate boiling (rewetting) shall be permitted when justified by the calculated local fluid and surface conditions during the reflood portion of a LOCA.
5.
b. The Groeneveld flow film boiling correlation (equation 5.7 of D.C. Groeneveld, “An Investigation of Heat Transfer in the Liquid Deficient Regime,” AECL-3281, revised December 1969) and the Westinghouse correlation of steady-state transition boiling (“Proprietary Redirect/Rebuttal Testimony of Westinghouse Electric Corporation,” USNRC Docket RM-50-1, page 25-1, October 26, 1972) are acceptable for use in the post-CHF boiling regimes. In addition, the transition boiling correlation of McDonough, Milich, and King (J.B. McDonough, W. Milich, E.C. King, “An Experimental Study of Partial Film Boiling Region with Water at Elevated Pressures in a Round Vertical Tube,” Chemical Engineering Progress Symposium Series, Vol. 57, No. 32, pages 197-208, (1961) is suitable for use between nucleate and film boiling. Use of all these correlations is restricted as follows:
(1) The Groeneveld correlation shall not be used in the region near its low-pressure singularity,
(2) The first term (nucleate) of the Westinghouse correlation and the entire McDonough, Milich, and King correlation shall not be used during the blowdown after the temperature difference between the clad and the saturated fluid first exceeds 300 °F,
(3) Transition boiling heat transfer shall not be reapplied for the remainder of the LOCA blowdown, even if the clad superheat returns below 300 °F, except for the reflood portion of the LOCA when justified by the calculated local fluid and surface conditions.
c. Evaluation models approved after October 17, 1988, which make use of the Dougall-Rohsenow flow film boiling correlation (R.S. Dougall and W.M. Rohsenow, “Film Boiling on the Inside of Vertical Tubes with Upward Flow of Fluid at Low Qualities,” MIT Report Number 9079 26, Cambridge, Massachusetts, September 1963) may not use this correlation under conditions where nonconservative predictions of heat transfer result. Evaluation models that make use of the Dougall-Rohsenow correlation and were approved prior to October 17, 1988, continue to be acceptable until a change is made to, or an error is corrected in, the evaluation model that results in a significant reduction in the overall conservatism in the evaluation model. At that time continued use of the Dougall-Rohsenow correlation under conditions where nonconservative predictions of heat transfer result will no longer be acceptable. For this purpose, a significant reduction in the overall conservatism in the evaluation model would be a reduction in the calculated peak fuel cladding temperature of at least 50 °F from that which would have been calculated on October 17, 1988, due either to individual changes or error corrections or the net effect of an accumulation of changes or error corrections.
6.
7.
a. The flow rate through the hot region of the core during blowdown shall be calculated as a function of time. For the purpose of these calculations the hot region chosen shall not be greater than the size of one fuel assembly. Calculations of average flow and flow in the hot region shall take into account cross flow between regions and any flow blockage calculated to occur during blowdown as a result of cladding swelling or rupture. The calculated flow shall be smoothed to eliminate any calculated rapid oscillations (period less than 0.1 seconds).
b. A method shall be specified for determining the enthalpy to be used as input data to the hot channel heatup analysis from quantities calculated in the blowdown analysis, consistent with the flow distribution calculations.
1.
2.
3.
The effects on reflooding rate of the compressed gas in the accumulator which is discharged following accumulator water discharge shall also be taken into account.
4.
5.
b. During refill and during reflood when reflood rates are less than one inch per second, heat transfer calculations shall be based on the assumption that cooling is only by steam, and shall take into account any flow blockage calculated to occur as a result of cladding swelling or rupture as such blockage might affect both local steam flow and heat transfer.
6.
a. During the period following lower plenum flashing but prior to the core spray reaching rated flow, a convective heat transfer coefficient of zero shall be applied to all fuel rods.
b. During the period after core spray reaches rated flow but prior to reflooding, convective heat transfer coefficients of 3.0, 3.5, 1.5, and 1.5 Btu-hr
c. After the two-phase reflooding fluid reaches the level under consideration, a convective heat transfer coefficient of 25 Btu-hr
7.
a. During the period after lower plenum flashing, but prior to core spray reaching rated flow, a convective coefficient of zero shall be applied to the fuel assembly channel box.
b. During the period after core spray reaches rated flow, but prior to wetting of the channel, a convective heat transfer coefficient of 5 Btu-hr
c. Wetting of the channel box shall be assumed to occur 60 seconds after the time determined using the correlation based on the Yamanouchi analysis (“Loss-of-Coolant Accident and Emergency Core Cooling Models for General Electric Boiling Water Reactors,” General Electric Company Report NEDO-10329, April 1971). This report was approved for incorporation by reference by the Director of the Federal Register. A copy of the report is available for inspection at the NRC Library, 11545 Rockville Pike, Rockville, Maryland 20852-2738.
1. a. A description of each evaluation model shall be furnished. The description shall be sufficiently complete to permit technical review of the analytical approach including the equations used, their approximations in difference form, the assumptions made, and the values of all parameters or the procedure for their selection, as for example, in accordance with a specified physical law or empirical correlation.
b. A complete listing of each computer program, in the same form as used in the evaluation model, must be furnished to the Nuclear Regulatory Commission upon request.
2. For each computer program, solution convergence shall be demonstrated by studies of system modeling or noding and calculational time steps.
3. Appropriate sensitivity studies shall be performed for each evaluation model, to evaluate the effect on the calculated results of variations in noding, phenomena assumed in the calculation to predominate, including pump operation or locking, and values of parameters over their applicable ranges. For items to which results are shown to be sensitive, the choices made shall be justified.
4. To the extent practicable, predictions of the evaluation model, or portions thereof, shall be compared with applicable experimental information.
5. General Standards for Acceptability—Elements of evaluation models reviewed will include technical adequacy of the calculational methods, including: For models covered by § 50.46(a)(1)(ii), compliance with required features of section I of this appendix K; and, for models covered by § 50.46(a)(1)(i), assurance of a high level of probability that the performance criteria of § 50.46(b) would not be exceeded.
1. “Applicant” means the entity applying for authority to construct or initially operate subject unit and each corporate parent, subsidiary and affiliate. Where application is made by two or more electric utilities not under common ownership or control, each utility, subject to the applicable exclusions contained in § 50.33a, should set forth separate responses to each item herein.
2. “Subject unit” means the nuclear generating unit or units for which application for construction or operation is being made.
3. “Initially operate” a unit means to operate the unit pursuant to the first operating license issued by the Commission for the unit.
4. “Electric utility” or “system” means any entity owning, controlling or operating facilities for the generation or transmission or distribution of electric power.
5. “Coordination” means any arrangement between two or more systems for generation
6. “Coordinating power and energy” means energy transmitted in accordance with an arrangement for coordination including but not limited to emergency power, economy energy, deficiency power and associated energy, and maintenance power and energy.
7. Except where specifically mentioned otherwise, the term “reserve generating capacity” or “reserves” shall refer to installed reserves in contrast to spinning or operating reserves.
1. State separately for hydroelectric and thermal generating resources applicant's most recent peak load and dependable capacity for the same time period. State applicant's dependable capacity at time of system peak for each of the next 10 years for which information is available. Identify each new unit or resource. For hydroelectric generating capacity, indicate the number of kilowatt hours of use associated with each kilowatt of capacity during the “adverse water year” upon which dependable capacity is based. Indicate average annual kilowatt hour loads per kilowatt, associated with each system peak shown (exclusive of interchange arrangements).
2. State applicant's estimated annual load growth for each of the next 20 years or for the period applicant utilizes in system planning. Indicate growth both in kilowatt requirements and kilowatt hour requirements.
3. State estimated annual load growth in kilowatts and kilowatt hours of companies or pools upon which the economic justification of the subject unit is based for each of the next 20 years or for the period applicant utilized in system planning. Identify each company or pool member.
4. For the year the subject unit would first come on line, state estimated annual load growth in kilowatts and kilowatt hours of any coordinating group or pool of which the applicant is a member (other than the coordinating group or pool referred to in the applicant's response to item 3) which has generating and/or transmission planning functions. Identify each company or pool member whose loads are indicated in the response thereto.
5. State applicant's minimum installed reserve criterion (as a percentage of load)
6. Describe methods used as a basis to establish, or as a guide in establishing the criteria for applicant's and/or applicant's pool's minimum amount of installed reserves (e.g., (a) single largest unit down, (b) probability methods such as loss of load one day in 20 years, loss of capacity once in 5 years, (c) other methods and/or (d) judgment. List contingencies other than risk of forced outage that enter into the determination).
7. Indicate whether applicant's system interconnections are credited explicitly or implicitly in establishing applicant's installed reserves.
8. List rights to receive emergency power and obligations to deliver emergency power, rights or obligations to receive or deliver deficiency power or unit power, or other coordinating arrangements, by reference to applicant's Federal Power Commission (FPC) rate schedules (i.e., ABC Power & Light Co., FPC Rate Schedule No. 15 including supplements 1-5),
9. List, and provide the mailing address for non-affiliated electric utility systems with peak loads smaller than applicant's which serve either at wholesale or at retail adjacent to areas served by the applicant.
10. List separately those systems in Item 9 which purchase from applicant (a) all bulk power supply and (b) systems which purchase partial bulk power supply requirements.
11. State as to all power generated and sold by applicant the most recent average cost of bulk power supply experienced by applicant (a) at site of generating facilities, (b) at the delivery points from the primary transmission (backbone) system, (c) at delivery points from the secondary transmission system, and (d) at delivery points from the distribution system, in terms of dollars per kilowatt per year, in mills per kilowatt hour, and in both the kilowatt costs and kilowatt hour costs divided by the kilowatt hours. If wholesale sales are made at varying voltages, indicate average costs at each voltage.
12. State (a) for generating facilities and (b) for transmission subdivided by voltage classes, the most recent estimated cost of applicant's bulk power supply expansion program of which the subject unit is a part, in terms of dollars per kilowatt per year, in mills per kilowatt hour and in both the kilowatt costs and kilowatt hour costs divided by the kilowatt hours. Also state separately the most recently estimated cost of the subject unit(s).
13. List and describe all requests for, or indications of interest in, interconnection and/or coordination and purchases or sales of coordinating power and energy from adjacent utilities listed in item 9 since 1960 and state applicant's response thereto. List and describe all requests for, or indications of interest in, supply of full or partial requirements of bulk power for the same period and state applicant's response thereto.
14. List (a) agreements to which applicant is a party (reproducing relevant paragraphs) and (b) State laws (supply citations only) which restrict or preclude coordination by, with, between, or among any electric utilities or systems identified in applicant's response to items 8 and 9. List (a) agreements to which the applicant is a party (reproducing relevant paragraphs) and (b) State laws (supply citations only) which restrict or preclude substitution of service or establishment of service of full or partial bulk power supply requirements by an electric utility other than applicant to systems identified in items 8 and 9. Where the contract provision appears in contracts or rate schedules on file with a Federal agency, identify each in the same form as in previous responses. Where the contract has not been filed with a Federal agency, a copy should be supplied unless it has been supplied pursuant to another item hereto. Where it is not in writing, it should be described.
15. State, at point of delivery, average future costs of power purchased from applicant to adjacent systems identified in applicant's response to item 9 in terms of dollars/month/kw for capacity, mills/kw for energy and mills/kwh for both power and energy at purchaser's present load factor (a) at present load, (b) at 50 percent increase over present load, (c) at 100 percent increase over present load, and (d) at 200 percent increase over present load. (All costs should be determined under present rate schedules.) Where sales are made under contracts or rate schedules on file with a Federal agency and not included in the response to item 9, identify each in the same form as in previous responses. Where the contract has not been filed with a Federal agency, a copy should be supplied.
16. State whether applicant has prepared, caused to be prepared, or received engineering studies for generation and transmission expansion programs which include loads of each system in item 9.
17. List adjacent systems to which applicant has offered to sponsor or to conduct system surveys in contemplation of an offer by applicant to purchase, merge or consolidate with said adjacent system, subsequent to January 1, 1960.
18. List applicant's offers or proposals to purchase, merge or consolidate with electric utilities, subsequent to January 1, 1960.
19. List all acquisitions of or mergers or consolidations with electric utilities by applicant, subsequent to January 1, 1960, including:
(a) The name and principal place of business of the system prior to the acquisition, merger or consolidation;
(b) The date the acquisition, merger or consolidation was consummated;
(c) Gross annual revenue and most recent peak load, dependable capacity and the largest thermal generating unit of the system, prior to the dates of consummation.
20. State applicant's six (or fewer if there are not six) lowest industrial or large commercial rates for firm electric power supply in terms of cost for power and energy in mills per kilowatt hour (and separately, the demand and energy components) and indicate the portion of the charge attributed to bulk power supply. State the rates or rate blocks applicant utilizes for its six (or fewer if there are not six) promotional services such as electric space heating, electric hot water heating, and the like, in terms of mills per kilowatt hour for power and energy and indicate the portion of the rate or rate blocks attributed to bulk power supply.
Section 101 of the Atomic Energy Act of 1954, as amended, and § 50.10 require a Commission license to transfer or receive in interstate commerce, manufacture, produce, transfer, acquire, possess, use, import, or export any production or utilization facility. The regulations in the part require the issuance of a construction permit by the Commission before commencement of construction of a production or utilization facility, and the issuance of an operating license before operation of the facility. The provisions of this part relating to the facility licensing process are, in general, predicated on the assumption that the facility will be assembled and constructed on the site at which it is to be operated. In those circumstances, both facility design and site-related issues can be considered in the initial, construction permit stage of the licensing process.
However, under the Atomic Energy Act, a license may be sought and issued authorizing the manufacture of facilities but not their construction and installation at the sites on which the facilities are to be operated. Prior to the “commencement of construction”, as defined in § 50.10(c), of a facility (manufactured pursuant to such a Commission license) on the site at which it is to operate—that is preparation of the site and installation of the facility—a construction permit that, among other things, reflects approval of the site on which the facility is to be operated, must be issued by the Commission. This appendix sets out the particular requirements and provisions applicable to such situations where nuclear power reactors to be manufactured pursuant to a Commission license and subsequently installed at the site pursuant to a Commission construction permit, are of the type described in § 50.22. It thus codifies one approach to the standardization of nuclear power reactors.
1. Except as otherwise specified in this appendix or as the context otherwise indicates, the provisions in this part applicable to construction permits, including the requirement in § 50.58 for review of the application by the Advisory Committee on Reactor Safeguards and the holding of a public hearing, apply in context, with respect to matters of radiological health and safety, environmental protection, and the common defense and security, to licenses pursuant to this appendix M to manufacture nuclear power reactors (manufacturing licenses) to be operated at sites not identified in the license application.
2. An application for a manufacturing license pursuant to this appendix M must be submitted, as specified in § 50.4, and meet all the requirements of §§ 50.34(a) (1)-(9) and 50.34a (a) and (b), except that the preliminary safety analysis report shall be designated as a “design report” and any required information or analyses relating to site matters shall be predicated on postulated site parameters which must be specified in the application. The application must also include information pertaining to design features of the proposed reactor(s) that affect plans for coping with emergencies in the operation of the reactor(s).
3. An applicant for a manufacturing license pursuant to this appendix M shall submit with his application an environmental report as required of applicants for construction permits in accordance with subpart A of part 51 of this chapter, provided, however, that such report shall be directed at the manufacture of the reactor(s) at the manufacturing site; and, in general terms, at the construction and operation of the reactor(s) at an hypothetical site or sites having characteristics that fall within the postulated site parameters. The related draft and final environmental impact statement prepared by the Commission's regulatory staff will be similarly directed.
4. (a) Sections 50.10 (b) and (c), 50.12(b), 50.23, 50.30(d), 50.34(a)(10), 50.34a(c), 50.35 (a) and (c), 50.40(a), 50.45, 50.55(d), 50.56, and appendix J do not apply to manufacturing licenses. Appendices E and H apply to manufacturing licenses only to the extent that the requirements of these appendixes involve facility design features.
(b) The financial information submitted pursuant to § 50.33(f) and appendix C shall be directed at a demonstration of the financial qualifications of the applicant for the manufacturing license to carry out the manufacturing activity for which the license is sought.
5. The Commission may issue a license to manufacture one or more nuclear power reactors to be operated at sites not identified in the license application if the Commission finds that:
(a) The applicant has described the proposed design of and the site parameters postulated for the reactor(s), including, but not limited to, the principal architectural and engineering criteria for the design, and has identified the major features or components incorporated therein for the protection of the health and safety of the public.
(b) Such further technical or design information as may be required to complete the design report and which can reasonably be left for later consideration, will be supplied in a supplement to the design report.
(c) Safety features or components, if any, which require research and development have been described by the applicant and the
(d) On the basis of the foregoing, there is reasonable assurance that (i) such safety questions will be satisfactorily resolved before any of the proposed nuclear power reactor(s) are removed from the manufacturing site and (ii) taking into consideration the site criteria contained in part 100 of this chapter, the proposed reactor(s) can be constructed and operated at sites having characteristics that fall within the site parameters postulated for the design of the reactor(s) without undue risk to the health and safety of the public.
(e) The applicant is technically and financially qualified to design and manufacture the proposed nuclear power reactor(s).
(f) The issuance of a license to the applicant will not be inimical to the common defense and security or to the health and safety of the public.
(g) On the basis of the evaluations and analyses of the environmental effects of the proposed action required by subpart A of part 51 of this chapter and paragraph 3 of this appendix, the action called for is the issuance of the license.
When an applicant has supplied initially all of the technical information required to complete the application, including the final design of the reactor(s), the findings required for the issuance of the license will be appropriately modified to reflect that fact.
6. Each manufacturing license issued pursuant to this appendix will specify the number of nuclear power reactors authorized to be manufactured and the latest date for the completion of the manufacture of all such reactors. Upon good cause shown, the Commission will extend such completion date for a reasonable period of time.
7. The holder of a manufacturing license issued pursuant to this appendix M shall submit to the Commission the final design of the nuclear power reactor(s) covered by the license as soon as such design has been completed. Such submittal shall be in the form of an application for amendment of the manufacturing license.
8. The prohibition in § 50.10(c) against commencement of construction of a production or utilization facility prior to issuance of a construction permit applies to the transport of a nuclear power reactor(s) manufactured pursuant to a license issued pursuant to this appendix from the manufacturing facility to the site at which the reactor(s) will be installed and operated. In addition, such nuclear power reactor(s) shall not be removed from the manufacturing site until the final design of the reactor(s) has been approved by the Commission in accordance with paragraph 7.
9. An application for a permit to construct a nuclear power reactor(s) which is the subject of an application for a manufacturing license pursuant to this appendix M need not contain such information or analyses as have previously been submitted to the Commission in connection with the application for a manufacturing license, but shall contain, in addition to the information and analyses otherwise required by §§ 50.34(a) and 50.34a, sufficient information to demonstrate that the site on which the reactor(s) is to be operated falls within the postulated site parameters specified in the relevant manufacturing license application.
10. The Commission may issue a permit to construct a nuclear power reactor(s) which is the subject of an application for a manufacturing license pursuant to this appendix M if the Commission (a) finds that the site on which the reactor is to be operated falls within the postulated site parameters specified in the relevant application for a manufacturing license and (b) makes the findings otherwise required by this part. In no event will a construction permit be issued until the relevant manufacturing license has been issued.
11. An operating license for a nuclear power reactor(s) that has been manufactured under a Commission license issued pursuant to this appendix M may be issued by the Commission pursuant to § 50.57 and subpart A of part 51 of this chapter except that the Commission shall find, pursuant to § 50.57(a)(1), that construction of the reactor(s) has been substantially completed in conformity with both the manufacturing license and the construction permit and the applications therefor, as amended, and the provisions of the Act, and the rules and regulations of the Commission. Notwithstanding the other provisions of this paragraph, no application for an operating license for a nuclear power reactor(s) that has been manufactured under a Commission license issued pursuant to this appendix M will be docketed until the application for an amendment to the relevant manufacturing license required by paragraph 7 has been docketed.
12. In making the findings required by this part for the issuance of a construction permit or an operating license for a nuclear power reactor(s) that has been manufactured under a Commission license issued pursuant to this appendix, or an amendment to such a manufacturing license, construction permit, or operating license, the Commission will treat as resolved those matters which have
Section 101 of the Atomic Energy Act of 1954, as amended, and § 50.10 of this part require a Commission license to transfer or receive in interstate commerce, manufacture, produce, transfer, acquire, possess, use, import or export any production or utilization facility. The regulations in this part require the issuance of a construction permit by the Commission before commencement of construction of a production or utilization facility, except as provided in § 50.10(e), and the issuance of an operating license before operation of the facility.
The Commission's regulations in part 2 of this chapter specifically provide for the holding of hearings on particular issues separately from other issues involved in hearings in licensing proceedings (§ 2.761a, appendix A, section I(c)), and for the consolidation of adjudicatory proceedings and of the presentations of parties in adjudicatory proceedings such as licensing proceedings (§§ 2.715a, 2.716).
This appendix sets out the particular requirements and provisions applicable to situations in which applications are filed by one or more applicants for licenses to construct and operate nuclear power reactors of essentially the same design to be located at different sites.
1. Except as otherwise specified in this appendix or as the context otherwise indicates, the provisions of this part applicable to construction permits and operating licenses, including the requirement in § 50.58 for review of the application by the Advisory Committee on Reactor Safeguards and the holding of public hearings, apply to construction permits and operating licenses subject to this appendix N.
2. Applications for construction permits submitted pursuant to this appendix must include the information required by §§ 50.33, 50.33a, 50.34(a) and 50.34a (a) and (b) and be submitted as specified in § 50.4. The applicant shall also submit the information required by § 51.50 of this chapter.
For the technical information required by §§ 50.34(a) (1) through (5) and (8) and 50.34a (a) and (b), reference may be made to a single preliminary safety analysis of the design
3. Applications for operating licenses submitted pursuant to this appendix N shall include the information required by §§ 50.33, 50.34(b) and (c), and 50.34a(c). The applicant shall also submit the information required by § 51.53 of this chapter. For the technical information required by §§ 50.34(b)(2) through (5) and 50.34a(c), reference may be made to a single final safety analysis of the design.
This appendix sets out procedures for the filing, staff review and referral to the Advisory Committee on Reactor Safeguards of standard designs for a nuclear power reactor of the type described in § 50.22 or major portions thereof.
1. Any person may submit a proposed preliminary or final standard design for a nuclear power reactor of the type described in § 50.22 to the regulatory staff for its review. Such a submittal may consist of either the preliminary or final design for the entire reactor facility or the preliminary or final design of major portions thereof.
2. The submittal for review of the standard design must be made in the same manner and in the same number of copies as provided in §§ 50.4 and 50.30 for license applications.
3. The submittal for review of the standard design shall include the information described in § 50.33(a) through (d) and the applicable technical information required by §§ 50.34 (a) and (b), as appropriate, and 50.34a (other than that required by §§ 50.34(a) (6) and (10), 50.34(b)(1), (6)(i), (ii), (iv), and (v) and 50.34(b) (7) and (8)). The submittal shall also include a description, analysis and evaluation of the interfaces between the submitted design and the balance of the nuclear power plant. With respect to the requirements of §§ 50.34(a)(1), the submittal for review of a standard design shall include the site parameters postulated for the design, and an analysis and evaluation of the design in terms of such postulated site parameters. The information submitted pursuant to § 50.34(a)(7) shall be limited to the quality assurance program to be applied to the design, procurement and fabrication of the structures, systems, and components for which design review has been requested and the information submitted pursuant to § 50.34(a)(9) shall be limited to the qualifications of the person submitting the standard design to design the reactor or major portion thereof. The submittal shall also include information pertaining to design features that affect plans for coping with emergencies in the operation of the reactor or major portion thereof.
4. Once the regulatory staff has initiated a technical review of a submittal under this appendix, the submittal will be referred to the Advisory Committee on Reactor Safeguards (ACRS) for a review and report.
5. Upon completion of their review of a submittal under this appendix, the NRC regulatory staff shall publish in the
6. The determination and report by the regulatory staff shall not constitute a commitment to issue a permit or license, or in any way affect the authority of the Commission, Atomic Safety and Licensing Appeal Panel, Atomic Safety and Licensing Panel, and other presiding officers in any proceeding under subpart G of part 2 of this chapter.
7. The Commission may, on its own initiative or in response to a petition for rule making, approve the design in a rulemaking proceeding and in that event, the approved design will be subject to challenge only as provided in § 2.758 of this chapter. An environmental impact statement may be prepared for such a rule making action in accordance with §§ 51.20(b)(13) and 51.85 of this chapter. If an environmental impact statement is prepared, the Commission may require the petitioner for rulemaking to submit information to the Commission to aid the Commission in the preparation of the environmental impact statement.
8. Information requests to the approval holder regarding an approved design shall be evaluated prior to issuance to ensure that the burden to be imposed on respondents is justified in view of the potential safety significance of the issue to be addressed in the requested information. Each such evaluation performed by the NRC staff shall be in accordance with 10 CFR 50.54(f) and shall be approved by the Executive Director for Operations or his or her designee prior to issuance of the request.
This appendix sets out procedures for the filing, Staff review, and referral to the Advisory Committee on Reactor Safeguards of requests for early review of one or more site suitability issues relating to the construction and operation of certain utilization facilities separately from and prior to the submittal of applications for construction permits for the facilities. The appendix also sets out procedures for the preparation and issuance of Staff Site Reports and for their incorporation by reference in applications for the construction and operation of certain utilization facilities. The utilization facilities are those which are subject to § 51.20(b) of this chapter and are of the type specified in § 50.21(b) (2) or (3) or § 50.22 or are testing facilities. This appendix does not apply to proceedings conducted pursuant to subpart F of part 2 of this chapter.
1. Any person may submit information regarding one or more site suitability issues to the Commission's Staff for its review separately from and prior to an application for a construction permit for a facility. Such a submittal shall be accompanied by any fee required by part 170 of this chapter and shall consist of the portion of the information required of applicants for construction permits by §§ 50.33(a)-(c) and (e), and, insofar as it relates to the issue(s) of site suitability for which early review is sought, by §§ 50.34(a)(1)
2. The submittal for early review of site suitability issue(s) must be made in the same manner and in the same number of copies as provided in §§ 50.4 and 50.30 for license applications. The submittal must include sufficient information concerning a range of postulated facility design and operation parameters to enable the Staff to perform the requested review of site suitability issues. The submittal must contain suggested conclusions on the issues of site suitability submitted for review and must be accompanied by a statement of the bases or the reasons for those conclusions. The submittal must also list, to the extent possible, any long-range objectives for ultimate development of the site, state whether any site selection process was used in preparing the submittal, describe any site selection process used, and explain what consideration, if any, was given to alternative sites.
3. The Staff shall publish a notice of docketing of the submittal in the
4. Upon completion of review by the NRC staff and, if appropriate by the ACRS, of a submittal under this appendix, the NRC staff shall prepare a Staff Site Report which shall identify the location of the site, state the site suitability issues reviewed, explain the nature and scope of the review, state the conclusions of the staff regarding the issues reviewed and state the reasons for those conclusions. Upon issuance of an NRC Staff Site Report, the NRC staff shall publish a notice of the availability of the report in the
5. Any Staff Site Report prepared and issued in accordance with this appendix may be incorporated by reference, as appropriate, in an application for a construction permit for a utilization facility which is subject to § 51.20(b) of this chapter and is of the type specified in § 50.21(b) (2) or (3) or § 50.22 of this chapter or is a testing facility. The conclusions of the Staff Site Report will be reexamined by the staff where five years or more have elapsed between the issuance of the Staff Site Report and its incorporation by reference in a construction permit application.
6. Issuance of a Staff Site Report shall not constitute a commitment to issue a permit or license, to permit on-site work under § 50.10(e), or in any way affect the authority of the Commission, Atomic Safety and Licensing Appeal Panel, Atomic Safety and Licensing Board, and other presiding officers in any proceeding under subpart F and/or G of part 2 of this chapter.
7. The staff will not conduct more than one review of site suitability issues with regard to a particular site prior to the full construction permit review required by subpart A of part 51 of this chapter. The staff may decline to prepare and issue a Staff Site Report in response to a submittal under this appendix where it appears that, (a) in cases where no review of the relative merits of the submitted site and alternative sites under subpart A of part 51 of this chapter is requested, there is a reasonable likelihood that further Staff review would identify one or more preferable alternative sites and the Staff review of one or more site suitability issues would lead to an irreversible and irretrievable commitment of resources prior to the submittal of the analysis of alternative sites in the Environmental Report that would prejudice the later review and decision on alternative sites under subpart F and/or G of part 2 and subpart A of part 51 of this chapter; or (b) in cases where, in the judgment of the Staff, early review of any site suitability issue or issues would not be in the public interest, considering (1) the degree of likelihood that any early findings on those issues would retain their validity in later reviews, (2) the objections, if any, of cognizant state or local government agencies to the conduct of an early review on those issues, and (3) the possible effect on the public interest of having
This appendix applies to licensed nuclear power electric generating stations that were operating prior to January 1, 1979, except to the extent set forth in § 50.48(b) of this part. With respect to certain generic issues for such facilities it sets forth fire protection features required to satisfy Criterion 3 of appendix A to this part.
Criterion 3 of appendix A to this part specifies that “Structures, systems, and components important to safety shall be designed and located to minimize, consistent with other safety requirements, the probability and effect of fires and explosions.”
When considering the effects of fire, those systems associated with achieving and maintaining safe shutdown conditions assume major importance to safety because damage to them can lead to core damage resulting from loss of coolant through boiloff.
The phrases “important to safety,” or “safety-related,” will be used throughout this appendix R as applying to all safety functions. The phrase “safe shutdown” will be used throughout this appendix as applying to both hot and cold shutdown functions.
Because fire may affect safe shutdown systems and because the loss of function of systems used to mitigate the consequences of design basis accidents under postfire conditions does not per se impact public safety, the need to limit fire damage to systems required to achieve and maintain safe shutdown conditions is greater than the need to limit fire damage to those systems required to mitigate the consequences of design basis accidents. Three levels of fire damage limits are established according to the safety functions of the structure, system, or component:
The most stringent fire damage limit shall apply for those systems that fall into more than one category. Redundant systems used to mitigate the consequences of other design basis accidents but not necessary for safe shutdown may be lost to a single exposure fire. However, protection shall be provided so that a fire within only one such system will not damage the redundant system.
A.
The fire protection program shall be under the direction of an individual who has been delegated authority commensurate with the responsibilities of the position and who has available staff personnel knowledgeable in both fire protection and nuclear safety.
The fire protection program shall extend the concept of defense-in-depth to fire protection in fire areas important to safety, with the following objectives:
• To prevent fires from starting;
• To detect rapidly, control, and extinguish promptly those fires that do occur;
• To provide protection for structures, systems, and components important to safety so that a fire that is not promptly extinguished by the fire suppression activities will not prevent the safe shutdown of the plant.
B.
C.
1. In situ fire hazards shall be identified and suitable protection provided.
2. Transient fire hazards associated with normal operation, maintenance, repair, or modification activities shall be identified and eliminated where possible. Those transient fire hazards that can not be eliminated shall be controlled and suitable protection provided.
3. Fire detection systems, portable extinguishers, and standpipe and hose stations shall be installed.
4. Fire barriers or automatic suppression systems or both shall be installed as necessary to protect redundant systems or components necessary for safe shutdown.
5. A site fire brigade shall be established, trained, and equipped and shall be on site at all times.
6. Fire detection and suppression systems shall be designed, installed, maintained, and tested by personnel properly qualified by experience and training in fire protection systems.
7. Surveillance procedures shall be established to ensure that fire barriers are in place and that fire suppression systems and components are operable.
D.
A.
Each supply shall consist of a storage tank, pump, piping, and appropriate isolation and control valves. Two separate redundant suctions in one or more intake structures from a large body of water (river, lake, etc.) will satisfy the requirement for two separated water storage tanks. These supplies shall be separated so that a failure of one supply will not result in a failure of the other supply.
Each supply of the fire water distribution system shall be capable of providing for a period of 2 hours the maximum expected water demands as determined by the fire hazards analysis for safety-related areas or other areas that present a fire exposure hazard to safety-related areas.
When storage tanks are used for combined service-water/fire-water uses the minimum volume for fire uses shall be ensured by means of dedicated tanks or by some physical means such as a vertical standpipe for other water service. Administrative controls, including locks for tank outlet valves, are unacceptable as the only means to ensure minimum water volume.
Other water systems used as one of the two fire water supplies shall be permanently connected to the fire main system and shall be capable of automatic alignment to the fire main system. Pumps, controls, and power supplies in these systems shall satisfy the requirements for the main fire pumps. The use of other water systems for fire protection shall not be incompatible with their functions required for safe plant shutdown. Failure of the other system shall not degrade the fire main system.
B.
C.
D.
Access to permit effective functioning of the fire brigade shall be provided to all areas that contain or present an exposure fire hazard to structures, systems, or components important to safety.
Standpipe and hose stations shall be inside PWR containments and BWR containments that are not inerted. Standpipe and hose stations inside containment may be connected to a high quality water supply of sufficient quantity and pressure other than the fire main loop if plant-specific features prevent extending the fire main supply inside containment. For BWR drywells, standpipe and hose stations shall be placed outside the dry well with adequate lengths of hose to reach any location inside the dry well with an effective hose stream.
E.
F.
G.
a. One train of systems necessary to achieve and maintain hot shutdown conditions from either the control room or emergency control station(s) is free of fire damage; and
b. Systems necessary to achieve and maintain cold shutdown from either the control room or emergency control station(s) can be repaired within 72 hours.
2. Except as provided for in paragraph G.3 of this section, where cables or equipment, including associated non-safety circuits that could prevent operation or cause maloperation due to hot shorts, open circuits, or shorts to ground, of redundant trains of systems necessary to achieve and maintain hot shutdown conditions are located within the same fire area outside of primary containment, one of the following means of ensuring that one of the redundant trains is free of fire damage shall be provided:
a. Separation of cables and equipment and associated non-safety circuits of redundant trains by a fire barrier having a 3-hour rating. Structural steel forming a part of or supporting such fire barriers shall be protected to provide fire resistance equivalent to that required of the barrier;
b. Separation of cables and equipment and associated non-safety circuits of redundant trains by a horizontal distance of more than 20 feet with no intervening combustible or fire hazards. In addition, fire detectors and an automatic fire suppression system shall be installed in the fire area; or
c. Enclosure of cable and equipment and associated non-safety circuits of one redundant train in a fire barrier having a 1-hour rating, In addition, fire detectors and an automatic fire suppression system shall be installed in the fire area;
Inside noninerted containments one of the fire protection means specified above or one of the following fire protection means shall be provided:
d. Separation of cables and equipment and associated non-safety circuits of redundant trains by a horizontal distance of more than 20 feet with no intervening combustibles or fire hazards;
e. Installation of fire detectors and an automatic fire suppression system in the fire area; or
f. Separation of cables and equipment and associated non-safety circuits of redundant trains by a noncombustible radiant energy shield.
3. Alternative of dedicated shutdown capability and its associated circuits,
a. Where the protection of systems whose function is required for hot shutdown does not satisfy the requirement of paragraph G.2 of this section; or
b. Where redundant trains of systems required for hot shutdown located in the same fire area may be subject to damage from fire suppression activities or from the rupture or inadvertent operation of fire suppression systems.
In addition, fire detection and a fixed fire suppression system shall be installed in the area, room, or zone under consideration.
H.
The minimum equipment provided for the brigade shall consist of personal protective equipment such as turnout coats, boots, gloves, hard hats, emergency communications equipment, portable lights, portable ventilation equipment, and portable extinguishers. Self-contained breathing apparatus
At least a 1-hour supply of breathing air in extra bottles shall be located on the plant site for each unit of self-contained breathing appratus. In addition, an onsite 6-hour supply of reserve air shall be provided and arranged to permit quick and complete replenishment of exhausted air supply bottles as they are returned. If compressors are used as a source of breathing air, only units approved for breathing air shall be used and the compressors shall be operable assuming a loss of offsite power. Special care must be taken to locate the compressor in areas free of dust and contaminants.
I.
1.
a. The initial classroom instruction shall include:
(1) Indoctrination of the plant fire fighting plan with specific identification of each individual's responsibilities.
(2) Identification of the type and location of fire hazards and associated types of fires that could occur in the plant.
(3) The toxic and corrosive characteristics of expected products of combustion.
(4) Identification of the location of fire fighting equipment for each fire area and familiarization with the layout of the plant, including access and egress routes to each area.
(5) The proper use of available fire fighting equipment and the correct method of fighting each type of fire. The types of fires covered should include fires in energized electrical equipment, fires in cables and cable trays, hydrogen fires, fires involving flammable and combustible liquids or hazardous process chemicals, fires resulting from construction or modifications (welding), and record file fires.
(6) The proper use of communication, lighting, ventilation, and emergency breathing equipment.
(7) The proper method for fighting fires inside buildings and confined spaces.
(8) The direction and coordination of the fire fighting activities (fire brigade leaders only).
(9) Detailed review of fire fighting strategies and procedures.
(10) Review of the latest plant modifications and corresponding changes in fire fighting plans.
Items (9) and (10) may be deleted from the training of no more than two of the non-operations personnel who may be assigned to the fire brigade.
b. The instruction shall be provided by qualified individuals who are knowledgeable, experienced, and suitably trained in fighting the types of fires that could occur in the plant and in using the types of equipment available in the nuclear power plant.
c. Instruction shall be provided to all fire brigade members and fire brigade leaders.
d. Regular planned meetings shall be held at least every 3 months for all brigade members to review changes in the fire protection program and other subjects as necessary.
e. Periodic refresher training sessions shall be held to repeat the classroom instruction program for all brigade members over a two-year period. These sessions may be concurrent with the regular planned meetings.
2.
Practice sessions shall be held for each shift fire brigade on the proper method of fighting the various types of fires that could occur in a nuclear power plant. These sessions shall provide brigade members with experience in actual fire extinguishment and the use of emergency breathing apparatus under strenuous conditions encountered in fire fighting. These practice sessions shall be provided at least once per year for each fire brigade member.
3.
a. Fire brigade drills shall be performed in the plant so that the fire brigade can practice as a team.
b. Drills shall be performed at regular intervals not to exceed 3 months for each shift fire brigade. Each fire brigade member should participate in each drill, but must participate in at least two drills per year.
A sufficient number of these drills, but not less than one for each shift fire brigade per year, shall be unannounced to determine the fire fighting readiness of the plant fire brigade, brigade leader, and fire protection systems and equipment. Persons planning and authorizing an unannounced drill shall ensure that the responding shift fire brigade members are not aware that a drill is being planned until it is begun. Unannounced drills shall not be scheduled closer than four weeks.
At least one drill per year shall be performed on a “back shift” for each shift fire brigade.
c. The drills shall be preplanned to establish the training objectives of the drill and
d. At 3-year intervals, a randomly selected unannounced drill must be critiqued by qualified individuals independent of the licensee's staff. A copy of the written report from these individuals must be available for NRC review and shall be retained as a record as specified in section III.I.4 of this appendix.
e. Drills shall as a minimum include the following:
(1) Assessment of fire alarm effectiveness, time required to notify and assemble fire brigade, and selection, placement and use of equipment, and fire fighting strategies.
(2) Assessment of each brigade member's knowledge of his or her role in the fire fighting strategy for the area assumed to contain the fire. Assessment of the brigade member's conformance with established plant fire fighting procedures and use of fire fighting equipment, including self-contained emergency breathing apparatus, communication equipment, and ventilation equipment, to the extent practicable.
(3) The simulated use of fire fighting equipment required to cope with the situation and type of fire selected for the drill. The area and type of fire chosen for the drill should differ from those used in the previous drill so that brigade members are trained in fighting fires in various plant areas. The situation selected should simulate the size and arrangement of a fire that could reasonably occur in the area selected, allowing for fire development due to the time required to respond, to obtain equipment, and organize for the fire, assuming loss of automatic suppression capability.
(4) Assessment of brigade leader's direction of the fire fighting effort as to thoroughness, accuracy, and effectiveness.
4.
Individual records of training provided to each fire brigade member, including drill critiques, shall be maintained for at least 3 years to ensure that each member receives training in all parts of the training program. These records of training shall be available for NRC review. Retraining or broadened training for fire fighting within buildings shall be scheduled for all those brigade members whose performance records show deficiencies.
J.
K.
1. Govern the handling and limitation of the use of ordinary combustible materials, combustible and flammable gases and liquids, high efficiency particulate air and charcoal filters, dry ion exchange resins, or other combustible supplies in safety-related areas.
2. Prohibit the storage of combustibles in safety-related areas or establish designated storage areas with appropriate fire protection.
3. Govern the handling of and limit transient fire loads such as combustible and flammable liquids, wood and plastic products, or other combustible materials in buildings containing safety-related systems or equipment during all phases of operating, and especially during maintenance, modification, or refueling operations.
4. Designate the onsite staff member responsible for the inplant fire protection review of proposed work activities to identify potential transient fire hazards and specify required additional fire protection in the work activity procedure.
5. Govern the use of ignition sources by use of a flame permit system to control welding, flame cutting, brazing, or soldering operations. A separate permit shall be issued for each area where work is to be done. If work continues over more than one shift, the permit shall be valid for not more than 24 hours when the plant is operating or for the duration of a particular job during plant shutdown.
6. Control the removal from the area of all waste, debris, scrap, oil spills, or other combustibles resulting from the work activity immediately following completion of the activity, or at the end of each work shift, whichever comes first.
7. Maintain the periodic housekeeping inspections to ensure continued compliance with these administrative controls.
8. Control the use of specific combustibles in safety-related areas. All wood used in safety-related areas during maintenance, modification, or refueling operations (such as lay-down blocks or scaffolding) shall be treated with a flame retardant. Equipment or supplies (such as new fuel) shipped in untreated combustible packing containers may be unpacked in safety-related areas if required for valid operating reasons. However, all combustible materials shall be removed from the area immediately following the unpacking. Such transient combustible material, unless stored in approved containers, shall not be left unattended during lunch
9. Control actions to be taken by an individual discovering a fire, for example, notification of control room, attempt to extinguish fire, and actuation of local fire suppression systems.
10. Control actions to be taken by the control room operator to determine the need for brigade assistance upon report of a fire or receipt of alarm on control room annunciator panel, for example, announcing location of fire over PA system, sounding fire alarms, and notifying the shift supervisor and the fire brigade leader of the type, size, and location of the fire.
11. Control actions to be taken by the fire brigade after notification by the control room operator of a fire, for example, assembling in a designated location, receiving directions from the fire brigade leader, and discharging specific fire fighting responsibilities including selection and transportation of fire fighting equipment to fire location, selection of protective equipment, operating instructions for use of fire suppression systems, and use of preplanned strategies for fighting fires in specific areas.
12. Define the strategies for fighting fires in all safety-related areas and areas presenting a hazard to safety-related equipment. These strategies shall designate:
a. Fire hazards in each area covered by the specific prefire plans.
b. Fire extinguishants best suited for controlling the fires associated with the fire hazards in that area and the nearest location of these extinguishants.
c. Most favorable direction from which to attack a fire in each area in view of the ventilation direction, access hallways, stairs, and doors that are most likely to be free of fire, and the best station or elevation for fighting the fire. All access and egress routes that involve locked doors should be specifically identified in the procedure with the appropriate precautions and methods for access specified.
d. Plant systems that should be managed to reduce the damage potential during a local fire and the location of local and remote controls for such management (e.g., any hydraulic or electrical systems in the zone covered by the specific fire fighting procedure that could increase the hazards in the area because of overpressurization or electrical hazards).
e. Vital heat-sensitive system components that need to be kept cool while fighting a local fire. Particularly hazardous combustibles that need cooling should be designated.
f. Organization of fire fighting brigades and the assignment of special duties according to job title so that all fire fighting functions are covered by any complete shift personnel complement. These duties include command control of the brigade, transporting fire suppression and support equipment to the fire scenes, applying the extinguishant to the fire, communication with the control room, and coordination with outside fire departments.
g. Potential radiological and toxic hazards in fire zones.
h. Ventilation system operation that ensures desired plant air distribution when the ventilation flow is modified for fire containment or smoke clearing operations.
i. Operations requiring control room and shift engineer coordination or authorization.
j. Instructions for plant operators and general plant personnel during fire.
L.
2. The performance goals for the shutdown functions shall be:
a. The reactivity control function shall be capable of achieving and maintaining cold shutdown reactivity conditions.
b. The reactor coolant makeup function shall be capable of maintaining the reactor coolant level above the top of the core for BWRs and be within the level indication in the pressurizer for PWRs.
c. The reactor heat removal function shall be capable of achieving and maintaining decay heat removal.
d. The process monitoring function shall be capable of providing direct readings of the process variables necessary to perform and control the above functions.
e. The supporting functions shall be capable of providing the process cooling, lubrication, etc., necessary to permit the operation of the equipment used for safe shutdown functions.
3. The shutdown capability for specific fire areas may be unique for each such area, or it may be one unique combination of systems
4. If the capability to achieve and maintain cold shutdown will not be available because of fire damage, the equipment and systems comprising the means to achieve and maintain the hot standby or hot shutdown condition shall be capable of maintaining such conditions until cold shutdown can be achieved. If such equipment and systems will not be capable of being powered by both onsite and offsite electric power systems because of fire damage, an independent onsite power system shall be provided. The number of operating shift personnel, exclusive of fire brigade members, required to operate such equipment and systems shall be on site at all times.
5. Equipment and systems comprising the means to achieve and maintain cold shutdown conditions shall not be damaged by fire; or the fire damage to such equipment and systems shall be limited so that the systems can be made operable and cold shutdown can be achieved within 72 hours. Materials for such repairs shall be readily available on site and procedures shall be in effect to implement such repairs. If such equipment and systems used prior to 72 hours after the fire will not be capable of being powered by both onsite and offsite electric power systems because of fire damage, an independent onsite power system shall be provided. Equipment and systems used after 72 hours may be powered by offsite power only.
6. Shutdown systems installed to ensure postfire shutdown capability need not be designed to meet seismic Category I criteria, single failure criteria, or other design basis accident criteria, except where required for other reasons, e.g., because of interface with or impact on existing safety systems, or because of adverse valve actions due to fire damage.
7. The safe shutdown equipment and systems for each fire area shall be known to be isolated from associated non-safety circuits in the fire area so that hot shorts, open circuits, or shorts to ground in the associated circuits will not prevent operation of the safe shutdown equipment. The separation and barriers between trays and conduits containing associated circuits of one safe shutdown division and trays and conduits containing associated circuits or safe shutdown cables from the redundant division, or the isolation of these associated circuits from the safe shutdown equipment, shall be such that a postulated fire involving associated circuits will not prevent safe shutdown.
M.
1. The cable fire barrier penetration seal has withstood the fire endurance test without passage of flame or ignition of cables on the unexposed side for a period of time equivalent to the fire resistance rating required of the barrier;
2. The temperature levels recorded for the unexposed side are analyzed and demonstrate that the maximum temperature is sufficiently below the cable insulation ignition temperature; and
3. The fire barrier penetration seal remains intact and does not allow projection of water beyond the unexposed surface during the hose stream test.
N.
One of the following measures shall be provided to ensure they will protect the opening as required in case of fire:
1. Fire doors shall be kept closed and electrically supervised at a continuously manned location;
2. Fire doors shall be locked closed and inspected weekly to verify that the doors are in the closed position;
3. Fire doors shall be provided with automatic hold-open and release mechanisms and inspected daily to verify that doorways are free of obstructions; or
4. Fire doors shall be kept closed and inspected daily to verify that they are in the closed position.
The fire brigade leader shall have ready access to keys for any locked fire doors.
Areas protected by automatic total flooding gas suppression systems shall have electrically supervised self-closing fire doors or shall satisfy option 1 above.
O.
Such collection systems shall be capable of collecting lube oil from all potential pressurized and unpressurized leakage sites in the reactor coolant pump lube oil systems. Leakage shall be collected and drained to a vented closed container that can hold the entire lube oil system inventory. A flame arrester is required in the vent if the flash point characteristics of the oil present the hazard of fire flashback. Leakage points to be protected shall include lift pump and piping, overflow lines, lube oil cooler, oil fill and drain lines and plugs, flanged connections on oil lines, and lube oil reservoirs where such features exist on the reactor coolant pumps. The drain line shall be large enough to accommodate the largest potential oil leak.
This appendix applies to applicants for a design certification or combined license pursuant to part 52 of this chapter or a construction permit or operating license pursuant to part 50 of this chapter on or after January 10, 1997. However, for either an operating license applicant or holder whose construction permit was issued prior to January 10, 1997, the earthquake engineering criteria in Section VI of appendix A to 10 CFR part 100 continues to apply.
(a) Each applicant for a construction permit, operating license, design certification, or combined license is required by § 50.34 (a)(12), (b)(10), and General Design Criterion 2 of appendix A to this part to design nuclear power plant structures, systems, and components important to safety to withstand the effects of natural phenomena, such as earthquakes, without loss of capability to perform their safety functions. Also, as specified in § 50.54(ff), nuclear power plants that have implemented the earthquake engineering criteria described herein must shut down if the criteria in Paragraph IV(a)(3) of this appendix are exceeded.
(b) These criteria implement General Design Criterion 2 insofar as it requires structures, systems, and components important to safety to withstand the effects of earthquakes.
The evaluations described in this appendix are within the scope of investigations permitted by § 50.10(c)(1).
As used in these criteria:
The
A
The
The
(1) The integrity of the reactor coolant pressure boundary;
(2) The capability to shut down the reactor and maintain it in a safe shutdown condition; or
(3) The capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposures comparable to the guideline exposures of § 50.34(a)(1).
The following are pursuant to the seismic and geologic design basis requirements of § 100.23 of this chapter:
(a) Vibratory Ground Motion.
(1) Safe Shutdown Earthquake Ground Motion.
(i) The Safe Shutdown Earthquake Ground Motion must be characterized by free-field ground motion response spectra at the free ground surface. In view of the limited data available on vibratory ground motions of strong earthquakes, it usually will be appropriate that the design response spectra be smoothed spectra. The horizontal component of the Safe Shutdown Earthquake Ground Motion in the free-field at the foundation level of the structures must be an appropriate response spectrum with a peak ground acceleration of at least 0.1g.
(ii) The nuclear power plant must be designed so that, if the Safe Shutdown Earthquake Ground Motion occurs, certain structures, systems, and components will remain functional and within applicable stress, strain, and deformation limits. In addition to seismic loads, applicable concurrent normal operating, functional, and accident-induced loads must be taken into account in the design of these safety-related structures, systems, and components. The design of the nuclear power plant must also take into account the possible effects of the Safe Shutdown Earthquake Ground Motion on the facility foundations by ground disruption, such as fissuring, lateral spreads, differential settlement, liquefaction, and landsliding, as required in § 100.23 of this chapter.
(iii) The required safety functions of structures, systems, and components must be assured during and after the vibratory ground motion associated with the Safe Shutdown Earthquake Ground Motion through design, testing, or qualification methods.
(iv) The evaluation must take into account soil-structure interaction effects and the expected duration of vibratory motion. It is permissible to design for strain limits in excess of yield strain in some of these safety-related structures, systems, and components during the Safe Shutdown Earthquake Ground Motion and under the postulated concurrent loads, provided the necessary safety functions are maintained.
(2) Operating Basis Earthquake Ground Motion.
(i) The Operating Basis Earthquake Ground Motion must be characterized by response spectra. The value of the Operating Basis Earthquake Ground Motion must be set to one of the following choices:
(A) One-third or less of the Safe Shutdown Earthquake Ground Motion design response spectra. The requirements associated with this Operating Basis Earthquake Ground Motion in Paragraph (a)(2)(i)(B)(
(B) A value greater than one-third of the Safe Shutdown Earthquake Ground Motion design response spectra. Analysis and design must be performed to demonstrate that the requirements associated with this Operating Basis Earthquake Ground Motion in Paragraph (a)(2)(i)(B)(
(
(3) Required Plant Shutdown. If vibratory ground motion exceeding that of the Operating Basis Earthquake Ground Motion or if significant plant damage occurs, the licensee must shut down the nuclear power plant. If systems, structures, or components necessary for the safe shutdown of the nuclear power plant are not available after the occurrence of the Operating Basis Earthquake Ground Motion, the licensee must consult with the Commission and must propose a plan for the timely, safe shutdown of the nuclear power plant. Prior to resuming operations, the licensee must demonstrate to the Commission that no functional damage has occurred to those features necessary for continued operation without undue risk to the health and safety of the public and the licensing basis is maintained.
(4) Required Seismic Instrumentation. Suitable instrumentation must be provided so that the seismic response of nuclear power plant features important to safety can be evaluated promptly after an earthquake.
(b) Surface Deformation. The potential for surface deformation must be taken into account in the design of the nuclear power plant by providing reasonable assurance that in the event of deformation, certain structures, systems, and components will remain functional. In addition to surface deformation induced loads, the design of safety features must take into account seismic loads and applicable concurrent functional and accident-induced loads. The design provisions for surface deformation must be based on its postulated occurrence in any direction and azimuth and under any part of the nuclear power plant, unless evidence indicates this assumption is not appropriate, and must take into account the estimated rate at which the surface deformation may occur.
(c) Seismically Induced Floods and Water Waves and Other Design Conditions. Seismically induced floods and water waves from either locally or distantly generated seismic activity and other design conditions determined pursuant to § 100.23 of this chapter must be taken into account in the design of the nuclear power plant so as to prevent undue risk to the health and safety of the public.