[Federal Register Volume 68, Number 72 (Tuesday, April 15, 2003)]
[Notices]
[Pages 18297-18300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9027]
[[Page 18297]]
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NUCLEAR REGULATORY COMMISSION
State of Wisconsin: NRC Staff Draft Assessment of a Proposed
Agreement Between the Nuclear Regulatory Commission and the State of
Wisconsin
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of a proposed agreement with the State of Wisconsin.
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SUMMARY: By letter dated August 21, 2002, former Governor Scott
McCallum of Wisconsin requested that the U. S. Nuclear Regulatory
Commission (NRC) enter into an Agreement with the State as authorized
by section 274 of the Atomic Energy Act of 1954, as amended (Act).
Under the proposed Agreement, the Commission would relinquish, and
Wisconsin would assume, portions of the Commission's regulatory
authority exercised within the State. As required by the Act, NRC is
publishing the proposed Agreement for public comment. NRC is also
publishing the summary of a draft assessment by the NRC staff of the
Wisconsin regulatory program. Comments are requested on the proposed
Agreement and the staff's draft assessment which finds the Program
adequate to protect public health and safety and compatible with NRC's
program for regulation of Agreement material.
The proposed Agreement would release (exempt) persons who possess
or use certain radioactive materials in Wisconsin from portions of the
Commission's regulatory authority. The Act requires that NRC publish
those exemptions. Notice is hereby given that the pertinent exemptions
have been previously published in the Federal Register and are codified
in the Commission's regulations as 10 CFR part 150.
DATES: The comment period expires May 15, 2003. Comments received after
this date will be considered if it is practical to do so, but the
Commission cannot assure consideration of comments received after the
expiration date.
ADDRESSES: Written comments may be submitted to Mr. Michael T. Lesar,
Chief, Rules and Directives Branch, Division of Administrative
Services, Office of Administration, Washington, DC 20555-0001. Comments
may be submitted electronically at [email protected].
The NRC maintains an Agencywide Documents Access and Management
System (ADAMS), which provides text and image files of NRC's public
documents. The documents may be accessed through the NRC's Public
Electronic Reading Room on the Internet at http://www.nrc.gov/NRC/ADAMS/index.html. If you do not have access to ADAMS or if there are
problems in accessing the documents located in ADAMS, contact the NRC
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by e-mail to [email protected].
Copies of comments received by NRC may be examined at the NRC
Public Document Room, 11555 Rockville Pike, Public File Area O-1-F21,
Rockville, Maryland. Copies of the request for an Agreement by the
Governor of Wisconsin including all information and documentation
submitted in support of the request, and copies of the full text of the
NRC Staff Draft Assessment are also available for public inspection in
the NRC's Public Document Room--ADAMS Accession Numbers: ML030160104
and ML030900662.
FOR FURTHER INFORMATION CONTACT: Lloyd A. Bolling, Office of State and
Tribal Programs, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001. Telephone (301) 415-2327 or e-mail [email protected].
SUPPLEMENTARY INFORMATION: Since section 274 of the Act was added in
1959, the Commission has entered into Agreements with 32 States. The
Agreement States currently regulate approximately 16,250 agreement
material licenses, while NRC regulates approximately 4,900 licenses.
Under the proposed Agreement, approximately 260 NRC licenses will
transfer to Wisconsin. NRC periodically reviews the performance of the
Agreement States to assure compliance with the provisions of section
274.
Section 274e requires that the terms of the proposed Agreement be
published in the Federal Register for public comment once each week for
four consecutive weeks. This Notice is being published in fulfillment
of the requirement.
I. Background
(a) Section 274d of the Act provides the mechanism for a State to
assume regulatory authority, from the NRC, over certain radioactive
materials \1\ and activities that involve use of the materials.
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\1\ The radioactive materials are: (a) Byproduct materials as
defined in Section 11e.(1) of the Act; (b) byproduct materials as
defined in Section 11e.(2) of the Act; (c) source materials as
defined in Section 11z. of the Act; and (d) special nuclear
materials as defined in Section 11aa. of the Act, restricted to
quantities not sufficient to form a critical mass.
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In a letter dated August 21, 2002, former Governor McCallum
certified that the State of Wisconsin has a program for the control of
radiation hazards that is adequate to protect public health and safety
within Wisconsin for the materials and activities specified in the
proposed Agreement, and that the State desires to assume regulatory
responsibility for these materials and activities. Included with the
letter was the text of the proposed Agreement, which is shown in
Appendix A to this Notice.
The radioactive materials and activities (which together are
usually referred to as the ``categories of materials'') which the State
of Wisconsin requests authority over are: (1) The possession and use of
byproduct materials as defined in section 11e.(1) of the Act; (2) the
possession and use of source materials; and (3) the possession and use
of special nuclear materials in quantities not sufficient to form a
critical mass, as provided for in regulations or orders of the
Commission.
(b) The proposed Agreement contains articles that:
--Specify the materials and activities over which authority is
transferred;
--Specify the activities over which the Commission will retain
regulatory authority;
--Continue the authority of the Commission to safeguard nuclear
materials and restricted data;
--Commit the State of Wisconsin and NRC to exchange information as
necessary to maintain coordinated and compatible programs;
--Provide for the reciprocal recognition of licenses;
--Provide for the suspension or termination of the Agreement; and
--Specify the effective date of the proposed Agreement.
The Commission reserves the option to modify the terms of the
proposed Agreement in response to comments, to correct errors, and to
make editorial changes. The final text of the Agreement, with the
effective date, will be published after the Agreement is approved by
the Commission, and signed by the Chairman of the Commission and the
Governor of Wisconsin.
(c) Wisconsin currently registers users of naturally-occurring and
accelerator-produced radioactive materials. The regulatory program is
authorized by law in section 3145, subsection 254.34 of the revised
Wisconsin Statutes. Subsection 254.335(1) provides the authority for
the Governor to enter into an Agreement
[[Page 18298]]
with the Commission. Wisconsin law (subsection 254.335(2)) contains
provisions for the orderly transfer of regulatory authority over
affected licensees from NRC to the State. After the effective date of
the Agreement, licenses issued by NRC would continue in effect as
Wisconsin licenses until the licenses expire or are replaced by State-
issued licenses.
(d) The NRC staff draft assessment finds that the Wisconsin program
is adequate to protect public health and safety, and is compatible with
the NRC program for the regulation of agreement materials.
II. Summary of the NRC Staff Draft Assessment of the Wisconsin Program
for the Control of Agreement Materials
NRC staff has examined the Wisconsin request for an Agreement with
respect to the ability of the Wisconsin radiation control program to
regulate agreement materials. The examination was based on the
Commission's policy statement ``Criteria for Guidance of States and NRC
in Discontinuance of NRC Regulatory Authority and Assumption Thereof by
States Through Agreement'' (referred to herein as the ``NRC
criteria''), (46 FR 7540; January 23, 1981, as amended by policy
statements published at 46 FR 36969; July 16, 1981 and at 48 FR 33376;
July 21, 1983).
(a) Organization and Personnel. The agreement materials program
will be located within the existing Radiation Protection Section
(Program) of the Wisconsin Department of Health and Family Services.
The Program will be responsible for all regulatory activities related
to the proposed Agreement.
The educational requirements for the Program staff members are
specified in the Wisconsin State personnel position descriptions, and
meet the NRC criteria with respect to formal education or combined
education and experience requirements. All current staff members hold
at least bachelor's degrees in physical or life sciences, or have a
combination of education and experience at least equivalent to a
bachelor's degree. Several staff members hold advanced degrees, and all
staff members have had additional training plus working experience in
radiation protection. Supervisory level staff have more than ten years
working experience each, in radiation protection.
The Program currently has one staff vacancy, which they are
actively recruiting to fill. The Program performed, and NRC staff
reviewed, an analysis of the expected Program workload under the
proposed Agreement. Based on the NRC staff review of the State's staff
analysis, Wisconsin has an adequate number of staff to regulate
radioactive materials under the terms of the Agreement. The Program
will employ a staff of 9.5 full-time professional/technical and
administrative employees for the agreement materials program. The
distribution of the qualifications of the individual staff members will
be balanced to the distribution of categories of licensees transferred
from NRC. Each individual on the staff is qualified in accordance with
the Program's training and qualification procedure to function in the
areas of responsibility to which the individual is assigned.
(b) Legislation and Regulations. The Wisconsin Department of Health
and Family Services (DHFS) is designated by law in Chapter 254 of the
Wisconsin Revised Statutes to be the radiation control agency. The law
provides the DHFS the authority to issue licenses, issue orders,
conduct inspections, and to enforce compliance with regulations,
license conditions, and orders. Licensees are required to provide
access to inspectors. The DHFS is authorized to promulgate regulations.
The law requires the DHFS to adopt rules that are compatible with
equivalent NRC regulations and that are equally stringent to the
equivalent NRC regulations. Wisconsin has adopted HFS 157 Radiation
Protection Code effective August 1, 2002. The NRC staff reviewed and
forwarded comments on these regulations to the Wisconsin staff. The NRC
staff review verified that, with the comments incorporated, the
Wisconsin rules (and legally binding requirements) contain all of the
provisions that are necessary in order to be compatible with the
regulations of the NRC on the effective date of the Agreement between
the State and the Commission. The DHFS has extended the effect of the
rules, where appropriate, to apply to naturally occurring radioactive
materials and to radioactive materials produced in particle
accelerators, in addition to agreement materials. The NRC staff also
concludes that Wisconsin will not attempt to enforce regulatory matters
reserved to the Commission.
Wisconsin regulations are different from the NRC regulations with
respect to the termination of the license. Current NRC regulations
permit a license to be terminated when the facility has been
decommissioned, i.e., cleaned of radioactive contamination, such that
the residual radiation will not cause a total effective dose equivalent
greater than 25 millirem per year to an average member of the group of
individuals reasonably expected to receive the greatest exposure.
Normally, the NRC regulations require that the 25 millirem dose
constraint be met without imposing any restrictions regarding the
future use of the land or buildings of the facility (``unrestricted
release''). Under certain circumstances, NRC regulations in 10 CFR part
20, subpart E, allow a license to be terminated if the 25 millirem dose
constraint is met with restrictions on the future use (``restricted
release''). Wisconsin law does not allow a license to be terminated
under restricted release conditions. Wisconsin will instead issue a
special ``decommissioning-possession only'' license as an alternate to
license termination under restricted release. NRC staff has concluded
that this approach is compatible with NRC regulations.
(c) Storage and Disposal. Wisconsin has also adopted NRC compatible
requirements for the handling and storage of radioactive material.
Wisconsin will not seek authority to regulate the land disposal of
radioactive material as waste. The Wisconsin waste disposal
requirements cover the preparation, classification and manifesting of
radioactive waste, generated by Wisconsin licensees, for transfer for
disposal to an authorized waste disposal site or broker.
(d) Transportation of Radioactive Material. Wisconsin has adopted
regulations compatible with NRC regulations in 10 CFR part 71. Part 71
contains the requirements that licensees must follow when preparing
packages containing radioactive material for transport. Part 71 also
contains requirements related to the licensing of packaging for use in
transporting radioactive materials. Wisconsin will not attempt to
enforce portions of the regulations related to activities, such as
approving packaging designs, which are reserved to NRC.
(e) Recordkeeping and Incident Reporting. Wisconsin has adopted the
sections compatible with the NRC regulations which specify requirements
for licensees to keep records, and to report incidents, accidents, or
events involving materials.
(f) Evaluation of License Applications. Wisconsin has adopted
regulations compatible with the NRC regulations that specify the
requirements which a person must meet in order to get a license to
possess or use radioactive materials. Wisconsin has also developed a
licensing procedures manual, along with the accompanying regulatory
guides, which are adapted from similar NRC documents and contain
guidance for the Program staff when evaluating license applications.
[[Page 18299]]
(g) Inspections and Enforcement. The Wisconsin radiation control
program has adopted a schedule providing for the inspection of
licensees as frequently as the inspection schedule used by NRC. The
Program has adopted procedures for the conduct of inspections, the
reporting of inspection findings, and the reporting of inspection
results to the licensees. The Program has also adopted, by rule based
on the Wisconsin Revised Statutes, procedures for the enforcement of
regulatory requirements.
(h) Regulatory Administration. The Wisconsin Department of Health
and Family Services is bound by requirements specified in State law for
rulemaking, issuing licenses, and taking enforcement actions. The
Program has also adopted administrative procedures to assure fair and
impartial treatment of license applicants. Wisconsin law prescribes
standards of ethical conduct for State employees.
(i) Cooperation with Other Agencies. Wisconsin law deems the holder
of an NRC license on the effective date of the proposed Agreement to
possess a like license issued by Wisconsin. The law provides that these
former NRC licenses will expire either 90 days after receipt from the
radiation control program of a notice of expiration of such license or
on the date of expiration specified in the NRC license, whichever is
earlier.
Wisconsin also provides for ``timely renewal.'' This provision
affords the continuance of licenses for which an application for
renewal has been filed more than 30 days prior to the date of
expiration of the license. NRC licenses transferred while in timely
renewal are included under the continuation provision. The Wisconsin
Radiation Protection Code provides exemptions from the State's
requirements for licensing of sources of radiation for NRC and U.S.
Department of Energy contractors or subcontractors. The proposed
Agreement commits Wisconsin to use its best efforts to cooperate with
the NRC and the other Agreement States in the formulation of standards
and regulatory programs for the protection against hazards of radiation
and to assure that Wisconsin's program will continue to be compatible
with the Commission's program for the regulation of agreement
materials. The proposed Agreement stipulates the desirability of
reciprocal recognition of licenses, and commits the Commission and
Wisconsin to use their best efforts to accord such reciprocity.
III. Staff Conclusion
Subsection 274d of the Act provides that the Commission shall enter
into an agreement under subsection 274b with any State if:
(a) The Governor of the State certifies that the State has a
program for the control of radiation hazards adequate to protect public
health and safety with respect to the agreement materials within the
State, and that the State desires to assume regulatory responsibility
for the agreement materials; and
(b) The Commission finds that the State program is in accordance
with the requirements of subsection 274o, and in all other respects
compatible with the Commission's program for the regulation of
materials, and that the State program is adequate to protect public
health and safety with respect to the materials covered by the proposed
Agreement.
On the basis of its draft assessment, the NRC staff concludes that
the State of Wisconsin meets the requirements of the Act. The State's
program, as defined by its statutes, regulations, personnel, licensing,
inspection, and administrative procedures, is compatible with the
program of the Commission and adequate to protect public health and
safety with respect to the materials covered by the proposed Agreement.
NRC will continue the formal processing of the proposed Agreement
which includes publication of this Notice once a week for four
consecutive weeks for public review and comment.
IV. Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, the NRC has determined that this action is not a
major rule and has verified this determination with the Office of
Information and Regulatory Affairs of the Office of Management and
Budget (OMB).
Dated at Rockville, Maryland, this 2nd day of April, 2003.
For the Nuclear Regulatory Commission.
Paul H. Lohaus,
Director, Office of State and Tribal Programs.
Appendix A
Agreement Between the United States Nuclear Regulatory Commission and
the State of Wisconsin for the Discontinuance of Certain Commission
Regulatory Authority and Responsibility Within the State Pursuant to
Section 274 of the Atomic Energy Act of 1954, as Amended
Whereas, The United States Nuclear Regulatory Commission
(hereinafter referred to as the Commission) is authorized under
Section 274 of the Atomic Energy Act of 1954, as amended
(hereinafter referred to as the Act), to enter into agreements with
the Governor of the State of Wisconsin providing for discontinuance
of the regulatory authority of the Commission within the State under
Chapters 6, 7, and 8, and Section 161 of the Act with respect to
byproduct materials as defined in Sections 11e. (1) and (2) of the
Act, source materials, and special nuclear materials in quantities
not sufficient to form a critical mass; and,
Whereas, The Governor of the State of Wisconsin is authorized
under s. 254.335 (1), Wisconsin Statutes, to enter into this
Agreement with the Commission; and,
Whereas, The Governor of the State of Wisconsin certified on
August 21, 2002, that the State of Wisconsin (hereinafter referred
to as the State) has a program for the control of radiation hazards
adequate to protect public health and safety with respect to the
materials within the State covered by this Agreement, and that the
State desires to assume regulatory authority for such materials;
and,
Whereas, The Commission found on [date] that the program of the
State for the regulation of the materials covered by this Agreement
is compatible with the Commission's program for the regulation of
such materials and is adequate to protect public health and safety;
and,
Whereas, The State and the Commission recognize the desirability
and importance of cooperation between the Commission and the State
in the formulation of standards for protection against hazards of
radiation and in assuring that State and Commission programs for
protection against hazards of radiation will be coordinated and
compatible; and,
Whereas, The Commission and the State recognize the desirability
of the reciprocal recognition of licenses, and of the granting of
limited exemptions from licensing of those materials subject to this
Agreement; and,
Whereas, This Agreement is entered into pursuant to the
provisions of the Atomic Energy Act of 1954, as amended;
Now, therefore, It is hereby agreed between the Commission and
the Governor of the State, acting on behalf of the State, as
follows:
Article I
Subject to the exceptions provided in articles II, IV, and V,
the Commission shall discontinue, as of the effective date of this
Agreement, the regulatory authority of the Commission in the State
under chapters 6, 7, and 8, and section 161 of the Act with respect
to the following materials:
A. By-product materials as defined in section 11e. (1) of the
Act;
B. Source materials;
C. Special nuclear materials in quantities not sufficient to
form a critical mass.
Article II
This Agreement does not provide for discontinuance of any
authority and the Commission shall retain authority and
responsibility with respect to:
A. The regulation of the construction and operation of any
production or utilization facility or any uranium enrichment
facility;
B. The regulation of the export from or import into the United
States of byproduct,
[[Page 18300]]
source, or special nuclear material, or of any production or
utilization facility;
C. The regulation of the disposal into the ocean or sea of
byproduct, source, or special nuclear material wastes as defined in
the regulations or orders of the Commission;
D. The regulation of the disposal of such other byproduct,
source, or special nuclear material as the Commission from time to
time determines by regulation or order should, because of the
hazards or potential hazards thereof, not be so disposed without a
license from the Commission;
E. The evaluation of radiation safety information on sealed
sources or devices containing byproduct, source, or special nuclear
materials and the registration of the sealed sources or devices for
distribution, as provided for in regulations or orders of the
Commission;
F. The regulation of the land disposal of byproduct, source, or
special nuclear material waste received from other persons;
G. The extraction or concentration of source material from
source material ore and the management and disposal of the resulting
byproduct material.
Article III
With the exception of those activities identified in Article II,
paragraphs A through D, this Agreement may be amended, upon
application by the State and approval by the Commission, to include
the additional areas specified in Article II, paragraphs E, F and G,
whereby the State can exert regulatory authority and responsibility
with respect to those activities and materials.
Article IV
Notwithstanding this Agreement, the Commission may from time to
time by rule, regulation, or order, require that the manufacturer,
processor, or producer of any equipment, device, commodity, or other
product containing source, byproduct, or special nuclear material
shall not transfer possession or control of such product except
pursuant to a license or an exemption from licensing issued by the
Commission.
Article V
This Agreement shall not affect the authority of the Commission
under subsection 161b or 161i of the Act to issue rules,
regulations, or orders to protect the common defense and security,
to protect restricted data, or to guard against the loss or
diversion of special nuclear material.
Article VI
The Commission will cooperate with the State and other Agreement
States in the formulation of standards and regulatory programs of
the State and the Commission for protection against hazards of
radiation and to assure that Commission and State programs for
protection against hazards of radiation will be coordinated and
compatible. The State agrees to cooperate with the Commission and
other Agreement States in the formulation of standards and
regulatory programs of the State and the Commission for protection
against hazards of radiation and will assure that the State's
program will continue to be compatible with the program of the
Commission for the regulation of materials covered by this
Agreement.
The State and the Commission agree to keep each other informed
of proposed changes in their respective rules and regulations, and
to provide each other the opportunity for early and substantive
contribution to the proposed changes.
The State and the Commission agree to keep each other informed
of events, accidents, and licensee performance that may have generic
implication or otherwise be of regulatory interest.
Article VII
The Commission and the State agree that it is desirable to
provide reciprocal recognition of licenses for the materials listed
in Article I licensed by the other party or by any other agreement
state. Accordingly, the Commission and the State agree to develop
appropriate rules, regulations, and procedures by which such
reciprocity will be accorded.
Article VIII
The Commission, upon its own initiative after reasonable notice
and opportunity for hearing to the State, or upon request of the
Governor of the State, may terminate or suspend all or part of this
agreement and reassert the licensing and regulatory authority vested
in it under the Act if the Commission finds that (1) such
termination or suspension is required to protect public health and
safety, or (2) the State has not complied with one or more of the
requirements of section 274 of the Act. The Commission may also,
pursuant to section 274j of the Act, temporarily suspend all or part
of this agreement if, in the judgement of the Commission, an
emergency situation exists requiring immediate action to protect
public health and safety and the State has failed to take necessary
steps. The Commission shall periodically review this Agreement and
actions taken by the State under this Agreement to ensure compliance
with Section 274 of the Act which requires a State program to be
adequate to protect public health and safety with respect to the
materials covered by the Agreement and to be compatible with the
Commission's program.
Article IX
This Agreement shall become effective on July 1, 2003, and shall
remain in effect unless and until such time as it is terminated
pursuant to Article VIII.
For the United States Nuclear Regulatory Commission.
Nils J. Diaz,
Chairman.
For the State of Wisconsin.
Jim Doyle,
Governor.
[FR Doc. 03-9027 Filed 4-14-03; 8:45 am]
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