As used in this part, terms shall have the following meaning:

(a) Communicable diseases means illnesses due to infectious agents or their toxic products, which may be transmitted from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment.

(b) Communicable period means the period or periods during which the etiologic agent may be transferred directly or indirectly from the body of the infected person or animal to the body of another.

(c) Conveyance means any land or air carrier, or any vessel as defined in paragraph (h) of this section.

(d) Incubation period means the period between the implanting of disease organisms in a susceptible person and the appearance of clinical manifestation of the disease.

(e) Interstate traffic means:

(1) The movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation that is entirely within a State or possession—

(i) From a point of origin in any State or possession to a point of destination in any other State or possession; or

(ii) Between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country.

(2) Interstate traffic does not include the following:

(i) The movement of any conveyance which is solely for the purpose of unloading persons or property transported from a foreign country, or loading persons or property for transportation to a foreign country.

(ii) The movement of any conveyance which is solely for the purpose of effecting its repair, reconstruction, rehabilitation, or storage.

(f) Possession means any of the possessions of the United States, including Puerto Rico and the Virgin Islands.

(g) State means any State, the District of Columbia, Puerto Rico, and the Virgin Islands.

(h) Vessel means any passenger-carrying, cargo, or towing vessel exclusive of:

(1) Fishing boats including those used for shell-fishing;

(2) Tugs which operate only locally in specific harbors and adjacent waters;

(3) Barges without means of self-propulsion;

(4) Construction-equipment boats and dredges; and

(5) Sand and gravel dredging and handling boats.

Whenever the Director of the Centers for Disease Control and Prevention determines that the measures taken by health authorities of any State or possession (including political subdivisions thereof) are insufficient to prevent the spread of any of the communicable diseases from such State or possession to any other State or possession, he/she may take such measures to prevent such spread of the diseases as he/she deems reasonably necessary, including inspection, fumigation, disinfection, sanitation, pest extermination, and destruction of animals or articles believed to be sources of infection.

A person who has a communicable disease in the communicable period shall not travel from one State or possession to another without a permit from the health officer of the State, possession, or locality of destination, if such permit is required under the law applicable to the place of destination. Stop-overs other than those necessary for transportation connections shall be considered as places of destination.

The master of any vessel or person in charge of any conveyance engaged in interstate traffic, on which a case or suspected case of a communicable disease develops shall, as soon as practicable, notify the local health authority at the next port of call, station, or stop, and shall take such measures to prevent the spread of the disease as the local health authority directs.

The following provisions are applicable with respect to any person who is in the communicable period of cholera, plague, smallpox, typhus or yellow fever, or who, having been exposed to any such disease, is in the incubation period thereof:

(a) Requirements relating to travelers. (1) No such person shall travel from one State or possession to another, or on a conveyance engaged in interstate traffic, without a written permit of the Surgeon General or his/her authorized representative.

(2) Application for a permit may be made directly to the Surgeon General or to his/her representative authorized to issue permits.

(3) Upon receipt of an application, the Surgeon General or his/her authorized representative shall, taking into consideration the risk of introduction, transmission, or spread of the disease from one State or possession to another, reject it, or issue a permit that may be conditioned upon compliance with such precautionary measures as he/she shall prescribe.

(4) A person to whom a permit has been issued shall retain it in his/her possession throughout the course of his/her authorized travel and comply with all conditions prescribed therein, including presentation of the permit to the operators of conveyances as required by its terms.

(b) Requirements relating to operation of conveyances. (1) The operator of any conveyance engaged in interstate traffic shall not knowingly:

(i) Accept for transportation any person who fails to present a permit as required by paragraph (a) of this section; or

(ii) Transport any person in violation of conditions prescribed in his/her permit.

(2) Whenever a person subject to the provisions of this section is transported on a conveyance engaged in interstate traffic, the operator thereof shall take such measures to prevent the spread of the disease, including submission of the conveyance to inspection, disinfection and the like, as an officer of the Public Health Service designated by the Surgeon General for such purposes deems reasonably necessary and directs.

Regulations prescribed in this part authorize the detention, isolation, quarantine, or conditional release of individuals, for the purpose of preventing the introduction, transmission, and spread of the communicable diseases listed in an Executive Order setting out a list of quarantinable communicable diseases, as provided under section 361(b) of the Public Health Service Act. Executive Order 13295, of April 4, 2003, contains the current revised list of quarantinable communicable diseases, and may be obtained at http://www.cdc.gov, or at http://www.archives.gov/federal_register. If this Order is amended, HHS will enforce that amended order immediately and update this reference.

The provisions of §§ 70.3, 70.4, 70.5, 70.7, and this section shall not apply to members of the military or naval forces, and medical care or hospital beneficiaries of the Army, Navy, Veterans' Administration, or Public Health Service, when traveling under competent orders: Provided, That in the case of persons otherwise subject to the provisions of § 70.5 the authority authorizing the travel requires precautions to prevent the possible transmission of infection to others during the travel period.

As used in this part:

Biological product means a biological product prepared and manufactured in accordance with the provisions of 9 CFR parts 102-104 and 21 CFR parts 312 and 600-680 and which, in accordance with such provisions, may be shipped in interstate traffic.

Diagnostic specimen means any human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue, and tissue fluids being shipped for purposes of diagnosis.

Etiologic agent means a viable microorganism or its toxin which causes, or may cause, human disease.

Interstate traffic means the movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation which is entirely within a State or possession, (a) from a point of origin in any State or possession to a point of destination in any other State or possession, or (b) between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country.

No person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material including, but not limited to, diagnostic specimens and biological products which such person reasonably believes may contain an etiologic agent unless such material is packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.

Notwithstanding the provisions of § 72.2, no person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material (other than biological products) known to contain, or reasonably believed by such person to contain, one or more of the following etiologic agents unless such material is packaged, labeled, and shipped in accordance with the requirements specified in paragraphs (a) through (f) of this section:

(a) Volume not exceeding 50 ml. Material shall be placed in a securely closed, watertight container (primary container (test tube, vial, etc.)) which shall be enclosed in a second, durable watertight container (secondary container). Several primary containers may be enclosed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed 50 ml. The space at the top, bottom, and sides between the primary and secondary containers shall contain sufficient nonparticulate absorbent material (e.g., paper towel) to absorb the entire contents of the primary container(s) in case of breakage or leakage. Each set of primary and secondary containers shall then be enclosed in an outer shipping container constructed of corrugated fiberboard, cardboard, wood, or other material of equivalent strength.

(b) Volume greater than 50 ml. Packaging of material in volumes of 50 ml. or more shall comply with requirements specified in paragraph (a) of this section. In addition, a shock absorbent material, in volume at least equal to that of the absorbent material between the primary and secondary containers, shall be placed at the top, bottom, and sides between the secondary container and the outer shipping container. Single primary containers shall not contain more than 1,000 ml of material. However, two or more primary containers whose combined volumes do not exceed 1,000 ml may be placed in a single, secondary container. The maximum amount of etiologic agent which may be enclosed within a single outer shipping container shall not exceed 4,000 ml.

(c) Dry ice. If dry ice is used as a refrigerant, it must be placed outside the secondary container(s). If dry ice is used between the secondary container and the outer shipping container, the shock absorbent material shall be placed so that the secondary container does not become loose inside the outer shipping container as the dry ice sublimates.

(d)(1) The outer shipping container of all materials containing etiologic agents transported in interstate traffic must bear a label as illustrated and described below:

(2) The color of material on which the label is printed must be white, the symbol red, and the printing in red or white as illustrated.

(3) The label must be a rectangle measuring 51 millimeters (mm) (2 inches) high by 102.5 mm (4 inches) long.

(4) The red symbol measuring 38 mm (11/2 inches) in diameter must be centered in a white square measuring 51 mm (2 inches) on each side.

(5) Type size of the letters of label shall be as follows:

(e) Damaged packages. The carrier shall promptly, upon discovery of evidence of leakage or any other damage to packages bearing an Etiologic Agents/Biomedical Material label, isolate the package and notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333, by telephone: (404) 633-5313. The carrier shall also notify the sender.

(f) Registered mail or equivalent system. Transportation of the following etiologic agents shall be by registered mail or an equivalent system which requires or provides for sending notification of receipt to the sender immediately upon delivery:

When notice of delivery of materials known to contain or reasonably believed to contain etiologic agents listed in § 72.3(f) is not received by the sender within 5 days following anticipated delivery of the package, the sender shall notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333 (telephone (404) 633-5313).

The Director, Center for Disease Control, may approve variations from the requirements of this section if, upon review and evaluation, it is found that such variations provide protection at least equivalent to that provided by compliance with the requirements specified in this section and such findings are made a matter of official record.

(a) Registration of facilities. (1) Prior to transferring or receiving a select agent listed in Appendix A of this part, a facility shall register with a registering entity authorized by the Secretary (paragraph (c) of this section) or be approved by the Secretary as equipped and capable of handling the covered agent at Biosafety Level (BL) 2, 3, or 4, depending on the agent.

(2) Registration will include:

(i) Sufficient information provided by the responsible facility official indicating that the applicant facility, and its laboratory or laboratories, are equipped and capable of handling the agents at BL 2, 3, or 4, depending upon the agent, and the type of work being performed with the agents;

(ii) Inspection of the applicant facility at the discretion of the Secretary or the registering entity in consultation with the Secretary;

(iii) Issuance by the registering entity of a registration number unique to each facility;

(iv) Collection of a periodic site registration fee by the registering entity or the Secretary.

A schedule of fees collected by the Secretary to cover the direct costs (e.g., salaries, equipment, travel) and indirect costs (e.g., rent, telephone service and a proportionate share of management and administration costs) related to administration of this part will be published in the Federal Register and updated annually.

(v) Follow-up inspections of the facility by the registering entity or the Secretary, as appropriate, to ensure the facility continues to meet approved standards and recordkeeping requirements.

(3) Such registration shall remain effective until relinquished by the facility or withdrawn by the Secretary or the registering entity.

(4) The registration may be denied or withdrawn by the registering entity or the Secretary based on:

(i) Evidence that the facility is not or is no longer capable of handling covered agents at the applicable biosafety level;

(ii) Evidence that the facility has handled covered agents in a manner in contravention of the applicable biosafety level requirements;

(iii) Evidence that the facility has or intends to use covered agents in a manner harmful to the health of humans;

(iv) Evidence that the facility has failed to comply with any provisions of this part or has acted in a manner in contravention of this part; or

(v) Failure to pay any required registration fee.

(5) The biosafety standards and requirements for BSL-2, 3, and 4 operations are contained in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,” Fourth Edition, May 1999 which is hereby incorporated by reference. The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR part 51 the incorporation by reference of the above publication. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop A-13 Atlanta, Georgia, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The manual is also available on the CDC web site at www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm.

(6) Additional specific requirements for handling toxins subject to this part must be met and are found in 29 CFR § 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories.”

(b) Appeals. A decision made by the Secretary or a registering entity to deny or withdraw registration of a particular facility may be appealed to the Secretary. An application for appeal must be received by the Secretary no later than 14 days after the appealing party's application for registration was denied or no later than 14 days after the appealing party's registration was withdrawn. The application must clearly identify the issues presented by the appeal and fully explain the appealing party's position with respect to those issues. The Secretary may allow the filing of opposing briefs, informal conferences, or whatever steps the Secretary considers appropriate to fairly resolve the appeal.

(c) Authorized registering entities. (1) the Secretary may authorize a state agency or private entity to register facilities under paragraph (a) of this section, if the Secretary determines that the registering entity's criteria for determining the biosafety standards for facilities handling select agents are consistent with the requirements contained in the CDC/NIH publication “Biosafety in Microbiological and Biomedical Laboratories,” Fourth Edition.

(2) A registering entity shall maintain:

(i) A database of all facilities formerly and currently registered as BL 2, 3, or 4 and capable of working with agents in Appendix A of this part. The database shall include the name and address of the registered facility, the date the facility was registered, the facility's registration number, and the name and phone number of the responsible facility official.

(ii) A copy of each CDC Form EA-101 transmitted by each transferor registered by that registering entity. Such forms shall be made readily accessible to the Secretary and to appropriate federal law enforcement authorities and/or authorized local law enforcement authorities.

(3) In the event the Secretary authorizes more than one registering entity, or if otherwise necessary, the Secretary may require the establishment of a consolidated database to carry out the provisions of § 72.6(c)(2).

(d) Requests for agents. (1) Prior to the transfer of any agent contained in Appendix A of this part, a CDC Form EA-101 must be completed for each transfer sought. As specified in CDC Form EA-101, the information provided must include:

(i) The name of the requestor and requesting facility;

(ii) The name of the transferor and transferring facility;

(iii) The names of the responsible facility officials for both the transferor and requestor;

(iv) The requesting facility's registration number;

(v) The transferring facility's registration number;

(vi) The name of the agent(s) being shipped;

(vii) The proposed use of the agent(s); and

(viii) The quantity (number of containers and amount per container) of the agent(s) being shipped.

(2) The form must be signed by the transferor and requestor, and the responsible facility officials representing both the transferring and requesting facilities.

(3) A copy of the completed CDC Form EA-101 must be retained by both transferring and requesting facilities for a period of five (5) years after the date of shipment or for five (5) years after the agents are consumed or properly disposed, whichever is longer.

(4) All CDC forms EA-101 must be produced upon request to appropriate federal and authorized local law enforcement authorities, officials authorized by the Secretary, and officials of the registering entity.

(e) Verification of registration. (1) Prior to transferring any agent covered by this part, the transferor's responsible facility official must verify with the requestor's responsible facility official, and as appropriate, with the registering entity:

(i) That the requesting facility retains a valid, current registration;

(ii) That the requestor is an employee of the requesting facility; and

(iii) That the proposed use of the agent by the requestor is correctly indicated on CDC Form EA-101.

(2) In the event that any party is unable to verify the information required in paragraph (e)(1) of this section, or there is suspicion that the agent may not be used for the requested purpose, then the party shall immediately notify CDC.

(f) Transfer. (1) Upon completion of the CDC Form EA-101 and verification of registration, the transferring facility must comply with the packaging and shipping requirements in this part or other applicable regulations when transferring the agent.

(2) The requesting facility's responsible official must acknowledge receipt of the agent telephonically or otherwise electronically within 36 hours of receipt and provide a paper copy or facsimile transmission of receipt to the transferor within 3 business days of receipt of the agent.

(3) Upon telephonic acknowledgment of receipt of the agent, the transferor shall provide a completed paper copy or facsimile transmission of CDC Form EA-101 within 24 hours to the registering entity (holding that facility's registration), in accordance with § 72.6(c)(2) for filing in a centralized repository.

(g) Inspections. (1) Registering entities or the Secretary may conduct random or for cause inspections of registered facilities to assure compliance with this part. All CDC forms EA-101 and records deemed relevant by inspecting officials must be produced upon request to authorized personnel conducting these inspections. Inspections may also include review of the mechanisms developed by a facility to track intrafacility transfers as well as the facility's agent disposal procedures.

(2) In addition, the Secretary may conduct inspections of registering entities, and/or any consolidated database established in accordance with § 72.6(c)(3), to assure compliance with this part.

(h) Exemptions—(1) Exemptions for certain select agents: Select agents otherwise covered by this part are exempt from its provisions if:

(i) The agent is part of a clinical specimen intended for diagnostic, reference, or verification purposes. Isolates of covered agents from clinical specimens shall be disposed of in accordance with § 72.6(i) after diagnostic, reference, or verification procedures have been completed;

(ii) The agent is a toxin having an LD50 for vertebrates of more than 100 nanograms per kilogram of body weight which is used for legitimate medical purposes or biomedical research or is one of the listed toxins which has been inactivated for use as a vaccine or otherwise detoxified for use in biomedical research procedures; or

(iii) The agent(s) is an exempted strain specified in Appendix A of this part and/or CDC Form EA-101. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents (Appendix A of this part). Individuals seeking additions to the list of exemptions should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future changes to the list of exemptions will be published in the Federal Register for review and comment prior to inclusion on Appendix A of this part.

(2) Exemption of CLIA certified laboratories: Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, (42 U.S.C. 263a) (CLIA), that utilize these select agents for diagnostic, reference, verification, or proficiency testing purposes are exempt from the provisions of § 72.6.

(3) Procedures for facilities that are not CLIA laboratories but are transferring or receiving select agents to or from a CLIA laboratory: Facilities that are not CLIA laboratories but are transferring or receiving select agents to or from a CLIA laboratory must comply with the following provisions. (No additional paperwork on behalf of CLIA laboratories is required by this section.)

(i) Prior to transferring a select agent subject to this part to a CLIA laboratory for diagnostic, reference, verification, or proficiency testing purposes, the transferor must:

(A) Provide the following information on CDC Form EA-101:

(1) The name of the requestor and requesting facility;

(2) The name of the transferor and transferring facility;

(3) The name of the transferor's responsible facility official;

(4) The requesting facility's CLIA certification number (which the transferor must verify as valid and current with the registering entity);

(5) The transferring facility's registration number;

(6) The name of the agent(s) being shipped;

(7) The proposed use of the agent(s); and

(8) The quantity (number of containers and amount per container) of the agent(s) being shipped.

(B) Verify receipt of the agent with the CLIA laboratory and note such receipt on CDC Form EA-101;

(C) Transmit a copy of the form, signed by the transferror and the responsible facility official representing the transfering facility, to the registering entity holding the transferring facility's registration; and

(D) Retain a copy of CDC Form EA-101 in accordance with § 72.6(d)(3) and § 72.6(d)(4).

(ii) Prior to receiving a select agent listed in Appendix A of this part from a CLIA laboratory, the requestor must be registered in accordance with § 72.6(a) and comply with the following requirements:

(A) Provide the following information on the CDC Form EA-101:

(1) The name of the requestor and requesting facility;

(2) The name of the transferor and transferring facility;

(3) The name of the requestor's responsible facility official;

(4) The transferring facility's CLIA certification number;

(5) The requesting facility's registration number;

(6) The name of the agent(s) being shipped;

(7) The proposed use of the agent(s); and

(8) The quantity (number of containers and amount per container) of the agent(s) being shipped.

(B) Upon receiving the agent, note such receipt on CDC Form EA-101;

(C) Transmit a copy of CDC Form EA-101, signed by the requestor and the responsible facility official representing the requesting facility, to the registering entity holding the requesting facility's registration;

(D) Retain a copy of the CDC Form EA-101 in accordance with §§ 72.6(d)(3) and 72.6(d)(4);

(E) Comply with the disposal requirements of § 72.6(i) and all other sections of this part when subsequently transferring the agent.

(i) Agent disposal. (1) Upon termination of the use of the agent, all cultures and stocks of it will be

(i) Securely stored in accordance with prudent laboratory practices,

(ii) Transferred to another registered facility in accordance with this part, or

(iii) Destroyed on-site by autoclaving, incineration, or another recognized sterilization or neutralization process.

(2) When an agent, previously transferred to a facility in accordance with this part, is consumed or destroyed, the responsible facility official must formally notify the registering entity. Formal notification must be noted on CDC Form EA-101 and a copy kept on record by the responsible facility official for a period of five (5) years and is subject to paragraph (g) of this section.

(j) Definitions. As used in this section:

Facility means any individual or government agency, university, corporation, company, partnership, society, association, firm, or other legal entity located at a single geographic site that may transfer or receive through any means a select agent subject to this part.

Registering entity means an organization or state agency authorized by the Secretary to register facilities as capable of handling select agents at Biosafety Level 2, 3, or 4, depending on the agent, in accordance with the CDC/NIH publication “Biosafety in Microbiological and Biomedical Laboratories.”

Requestor means any person who receives or seeks to receive through any means a select agent subject to this part from any other person.

Responsible facility official means an official authorized to transfer and receive select agents covered by this part on behalf of the transferor's and/or requestor's facility. This person should be either a safety officer, a senior management official of the facility, or both. The responsible facility official should not be an individual who actually transfers or receives an agent at the facility.

Secretary means the Secretary of the Department of Health and Human Services or her or his designee.

Select agent means a microorganism (virus, bacterium, fungus, rickettsia) or toxin listed in Appendix A of this part. The term also includes:

(1) Genetically modified microorganisms or genetic elements from organisms on Appendix A of this part, shown to produce or encode for a factor associated with a disease, and

(2) Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins on Appendix A of this part, or their toxic submits.

Single geographic site means a building or complex of buildings at a single mailing address.

Transfer means:

(1) The conveyance or movement from a point or origination to a point of destination either:

(i) From one state or territory to another or;

(ii) Entirely within one contiguous state or territory.

(2) Intrafacility transfers within a registered facility located at a single geographic site are not covered by the provisions of § 72.6 (d), (e), and (f) provided that:

(i) The intended use of the agent remains consistent with that specified in the most current transfer form; and

(ii) For each intrafacility transfer, the facility maintains records that include the name and location of the recipient; the amount of agent transferred, and the date transferred. Such records must be maintained for a period of five (5) years after the date of transfer or for five (5) years after the agents are consumed or properly disposed, whichever is longer.

Transferor means any person who transfers or seeks to transfer through any means a select agent subject to this part to any other person.

Individuals in violation of this part are subject to a fine of no more than $250,000 or one year in jail, or both. Violations by organizations are subject to a fine or no more than $500,000 per event. A false, fictitious, or fraudulent statement or representation on the Government forms required in the part for registration of facilities or for transfers of select agents is subject to a fine or imprisonment for not more than five years, or both for an individual; and a fine for an organization.

For purposes of this part:

Biological agent means any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; deterioration of food, water, equipment, supplies, or material of any kind; or deleterious alteration of the environment.

CDC means Centers for Disease Control and Prevention of the Department of Health and Human Services.

Diagnosis means the analysis of specimens for the purpose of identifying or confirming the presence of a listed select agent or toxin provided that such analysis is directly related to protecting the public health or safety.

Entity means any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.

HHS means the Department of Health and Human Services.

HHS Secretary means the Department of Health and Human Services or his or her designee, unless otherwise specified.

HHS select agent or toxin means a biological agent or toxin included in § 73.4.

Overlap select agent or toxin means a biological agent or toxin included in § 73.5.

Proficiency testing means a sponsored, time-limited analytical trial whereby one or more analytes, previously confirmed by the sponsor, are submitted to the testing laboratory for analysis and where final results are graded, scores are recorded and provided to participants, and scores for participants are evaluated.

Principal investigator means the one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program.

Select agent or toxin or select agent and toxin without identification as HHS or overlap means all of those biological agents or toxins included in §§ 73.4 and 73.5 of this part.

Toxin means the toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such a substance.

United States means the United States of America, the District of Columbia, Puerto Rico, and the territories and possessions of the United States.

USDA means the United States Department of Agriculture.

USDA Secretary means the Department of Agriculture or his or her designee, unless otherwise specified.

Verification means the processes required to assure the accuracy, precision, and the analytical sensitivity and specificity of any procedure used for diagnosis.

(a) This part sets forth requirements regarding the possession or use in the United States, receipt from outside the United States, or transfer within the United States, of select agents and toxins. The requirements are designed to implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). The Act was designed to provide protection against the effects of misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland or other criminal acts. The agents and toxins subject to requirements under this part are those that have the potential to pose a severe threat to public health and safety. They are further identified as either HHS select agents and toxins or overlap select agents and toxins. The term HHS select agents and toxins refers to those select agents and toxins subject to these regulations but not subject to USDA requirements at 9 CFR part 121. The overlap group consists of those select agents and toxins subject to requirements promulgated by the HHS Secretary under this part and also subject to corresponding requirements promulgated by USDA at 9 CFR part 121.

(b) This part does not set requirements for the exportation of select agents or toxins. The Department of Commerce has primary responsibility for regulating the exportation of microorganisms and toxins in Title 15 of the Code of Federal Regulations.

(c) This part does not set requirements for the transportation in commerce of select agents or toxins. The Department of Transportation has primary responsibility for regulating the transportation of such select agents and toxins as hazardous materials under 49 CFR parts 171 through 180.

An entity or individual may not possess or use in the United States, receive from outside the United States, or transfer within the United States, a select agent or toxin unless such activities are conducted for a lawful purpose and in accordance with the provisions of this part. Registration, exclusions, and exemptions are automatically revoked when any event occurs that results in an entity or individual no longer being eligible.

Except for exclusions under paragraph (f) of this section, the viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic acids, and recombinant organisms specified in paragraphs (a) through (e) of this part are HHS select agents and toxins.

(a) Viruses:

(1) Crimean-Congo haemorrhagic fever virus.

(2) Ebola viruses.

(3) Cercopithecine herpesvirus 1 (Herpes B virus).

(4) Lassa fever virus.

(5) Marburg virus.

(6) Monkeypox virus.

(7) South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito).

(8) Tick-borne encephalitis complex (flavi) viruses (Central European Tick-borne encephalitis, Far Eastern Tick-borne encephalitis [Russian Spring and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic Fever]).

(9) Variola major virus (Smallpox virus) and Variola minor virus (Alastrim).

(b) Bacteria:

(1) Rickettsia prowazekii.

(2) Rickettsia rickettsii.

(3) Yersinia pestis.

(c) Fungi: Coccidioides posadasii.

(d) Toxins:

(1) Abrin.

(2) Conotoxins.

(3) Diacetoxyscirpenol.

(4) Ricin.

(5) Saxitoxin.

(6) Tetrodotoxin.

(7) Shiga-like ribosome inactivating proteins.

(e) Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms:

(1) Select agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the select agent viruses.

(2) Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed in paragraph (d) of this section if the nucleic acids:

(i) Are in a vector or host chromosome;

(ii) Can be expressed in vivo or in vitro; or

(iii) Are in a vector or host chromosome and can be expressed in vivo or in vitro.

(3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a) through (d) of this section that have been genetically modified.

(f) Exclusions:

(1) This section does not include any select agent or toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.

(2) This section does not include non-viable select agent organisms or nonfunctional toxins.

(3) Paragraph (a) of this section does not include the vaccine strain of Junin virus (Candid #1).

(4) Paragraph (d) of this section does not include the following toxins (in the purified form or in combinations of pure and impure forms) if the aggregate amount under the control of a principal investigator does not, at any time, exceed the amount specified: 100 mg of Abrin; 100 mg of Conotoxins; 1,000 mg of Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 100 mg of Shiga-like ribosome inactivating proteins; or 100 mg of Tetrodotoxin.

(5) The HHS Secretary may exclude from this section attenuated strains of HHS select agents or toxins upon a determination that they do not pose a severe threat to the public health and safety. To apply for an exclusion an applicant must submit a request in writing in accordance with § 73.21 to the HHS Secretary establishing that the attenuated strain or toxin is eligible for exclusion. The HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request. An exclusion will be effective upon notification to the applicant. Exclusions will be published in the notice section of the Federal Register and will be listed on the CDC Web site at http://www.cdc.gov. Exclusions also will be referenced in this section when changes are made based on periodic reviews.

Except for exclusions under paragraph (f) of this section, the viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic acids, and recombinant organisms specified in paragraphs (a) through (e) of this part are overlap select agents and toxins.

(a) Viruses:

(1) Eastern Equine Encephalitis virus.

(2) Nipah and Hendra Complex viruses.

(3) Rift Valley fever virus.

(4) Venezuelan Equine Encephalitis virus.

(b) Bacteria:

(1) Bacillus anthracis.

(2) Brucella abortus.

(3) Brucella melitensis.

(4) Brucella suis.

(5) Burkholderia mallei (formerly Pseudomonas mallei).

(6) Burkholderia pseudomallei (formerly Pseudomonas pseudomallei).

(7) Botulinum neurotoxin producing species of Clostridium.

(8) Coxiella burnetii.

(9) Francisella tularensis.

(c) Fungi: Coccidioides immitis.

(d) Toxins:

(1) Botulinum neurotoxins.

(2) Clostridium perfringens epsilon toxin.

(3) Shigatoxin.

(4) Staphylococcal enterotoxins.

(5) T-2 toxin.

(e) Genetic elements, recombinant nucleic acids, and recombinant organisms:

(1) Select agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the select agent viruses.

(2) Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed in paragraph (d) of this section if the nucleic acids:

(i) Are in a vector or host chromosome;

(ii) Can be expressed in vivo or in vitro; or

(iii) Are in a vector or host chromosome and can be expressed in vivo or in vitro.

(3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a) through (d) of this section that have been genetically modified.

(f) Exclusions:

(1) This section does not include any select agent or toxin that is in its naturally occurring environment provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.

(2) This section does not include non-viable select agent organisms or nonfunctional toxins.

(3) Paragraph (a) does not include the vaccine strain of Rift Valley fever virus (MP-12) or Venezuelan Equine encephalitis virus vaccine strain TC-83.

(4) Paragraph (d) of this section does not include the following toxins (in the purified form or in combinations of pure and impure forms) if the aggregate amount under the control of a principal investigator does not, at any time, exceed the amount specified: 0.5 mg of Botulinum neurotoxins; 5 mg of Staphylococcal enterotoxins; 100 mg of Clostridium perfringens epsilon toxin; 100 mg of Shigatoxin; or 1,000 mg of T-2 toxin.

(5) The HHS Secretary, after consultation with the USDA Secretary, may exclude from this section attenuated strains of overlap select agents or toxins upon a determination that they do not pose a severe threat to the public health and safety and do not meet the criteria in 9 CFR part 121 for inclusion. To apply for an exclusion, an applicant must submit a request in writing in accordance with § 73.21 to the HHS Secretary or the USDA Secretary in accordance with 9 CFR part 121, establishing that the attenuated strain is eligible for exclusion. In response to an application submitted to the HHS Secretary, the HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request. An exclusion will be effective upon notification to the applicant. Exclusions will be published in the notice section of the Federal Register and will be listed on the CDC Web site at http://www.cdc.gov. Also, they will be referenced in this section when changes are made based on periodic reviews.

(a) An entity is exempt from the provisions of this part, other than § 73.14 (transfer), provided that all of the following apply:

(1) The only activities conducted by the entity that are subject to this part concern select agents or toxins that are contained in specimens or in isolates from specimens presented for diagnosis, verification, or proficiency testing;

(2) Upon identification of a select agent or toxin as the result of diagnosis or verification, the entity immediately reports to the HHS Secretary by telephone, facsimile, or e-mail in accordance with § 73.21 any of the following: Variola major virus (Smallpox virus) and Variola minor (Alastrim), Bacillus anthracis, Yersinia pestis, Botulinum neurotoxins, Francisella tularensis, Ebola viruses, Marburg virus, Lassa fever virus, and South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito);

(3) The entity reports as required under Federal, State, or local law, to appropriate authorities;

(4) After the diagnosis, verification, or proficiency testing, the entity either transfers the specimens or isolates containing a select agent or toxin from the specimens to a facility eligible for receiving them under this part, or destroys them on-site by autoclaving, incineration, or by a sterilization or neutralization process sufficient to cause inactivation;

(5) The entity transfers or destroys those select agents or toxins used for diagnosis or testing within seven days after identification, unless directed otherwise by the Federal Bureau of Investigation or other law enforcement entity after consultation with the HHS Secretary; and

(6) The entity transfers or destroys those select agents or toxins used for proficiency testing within 90 days after receipt; and

(7) The entity prepares a record of the identification and transfer or destruction on CDC Form 0.1318, submits the completed form to the HHS Secretary in accordance with § 73.21 within seven days after identification, and maintains a copy of the record for a period of three years.

(b) Unless the HHS Secretary issues an order to an entity making specific provisions of this part applicable to protect the public health and safety, products that are, bear, or contain listed select agents or toxins that are cleared, approved, licensed, or registered under any of the following laws, are exempt from the provisions of this part insofar as their use is only for the approved purpose and meets the requirements of such laws:

(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);

(2) Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262);

(3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C. 151-159); or

(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq).

(c) The HHS Secretary may exempt from the requirements of this part on a case-by-case basis an investigational product that is, bears, or contains a select agent or toxin, when such product is being used in an investigation authorized under a Federal Act referred to in paragraph (b) of this section and additional regulation under this part is not necessary to protect public health and safety. To apply for an exemption an applicant must submit to the HHS Secretary in accordance with § 73.21 a completed CDC Form 0.1317 certifying that the product is being used in an investigation authorized under a Federal Act referred to in paragraph (b) of this section, and that additional regulation under this part is not necessary to protect public health and safety. The HHS Secretary shall make a determination regarding the application within 14 calendar days after receipt, provided the application meets all of the requirements of this section and the application establishes that the investigation has been authorized under the cited Act. The HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request. The applicant must notify the HHS Secretary when an authorization for an investigation no longer exists. This exemption automatically ceases when such authorization is no longer in effect.

(d) The HHS Secretary may temporarily exempt an entity from the requirements of this part, in whole or in part, based on a determination that the exemption is necessary to provide for the timely participation of the entity in response to a domestic or foreign public health emergency. With respect to the emergency involved, the exemption may not exceed 30 days, except that the HHS Secretary may grant one extension of an additional 30 days. To apply for an exemption or an extension of an exemption, an applicant must submit to the HHS Secretary in accordance with § 73.21 a completed CDC Form 0.1317 establishing the need to provide for the timely participation of the entity in a response to a domestic or foreign public health emergency. The HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request.

(e) Upon request of the USDA Secretary, after the USDA Secretary has granted an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of 2002 based on a finding that there is an agricultural emergency, the HHS Secretary may temporarily exempt an entity from the applicability of the requirements of this part, in whole or in part, to provide for the timely participation of the entity in response to the agricultural emergency. With respect to the emergency, the exemption under this part may not exceed 30 days, except that upon the request of the USDA Secretary, the HHS Secretary may grant one extension of an additional 30 days.

(a) An entity may not possess or use in the United States, receive from outside the United States, or transfer within the United States, any select agent or toxin unless the entity has been granted a certificate of registration by the HHS Secretary or the USDA Secretary.

(b) To apply for a certificate of registration an entity must:

(1) Obtain a registration application number from the HHS Secretary and then apply for approval under § 73.8 for the entity, the Responsible Official, and any individual who owns or controls the entity; and

(2) In accordance with § 73.21, submit the information requested to the HHS Secretary or the USDA Secretary as specified in the registration application package [CDC Form 0.1319]. Information submitted will be used to determine whether the applicant would be eligible to conduct activities under this part. Minimum information required includes:

(i) Identification information (e.g., name, address, contact numbers, identification number assigned by the Attorney General for compliance with § 73.8);

(ii) The name, source, and characterization information on select agents and toxins included in the registration, and quantities held at the time of the application;

(iii) The location, including building and room and floor plans for each building and room, where each select agent or toxin will be stored or used;

(iv) Information addressing safety, security, emergency response plans, and training, including descriptions of any equivalent measures adopted pursuant to § 73.11(d);

(v) The name, position, and identification information regarding the Responsible Official, including the identification number assigned by the Attorney General for compliance with § 73.8;

(vi) A list of individuals who will need access to select agents and toxins;

(vii) A certification statement signed by the Responsible Official attesting to the accuracy of the information submitted; and

(viii) Any other information necessary for the determination.

(c) An application that covers any HHS select agents or toxins (regardless of whether it also covers overlap select agents or toxins) must be submitted to the HHS Secretary in accordance with § 73.21. An application that covers only overlap select agents or toxins may be submitted to either the HHS Secretary or the USDA Secretary.

(d) A certificate of registration will be valid only for the specific select agents and toxins, and the specified activities and locations that are consistent with the information provided by the entity upon which the certificate of registration or amendment was granted. The Responsible Official must promptly notify the HHS Secretary in writing in accordance with § 73.21, if a change occurs in any information submitted to the HHS Secretary in the application for the certificate of registration or amendments. This includes modifications to the list of individuals approved under § 73.8, changes in area of work, or changes in protocols or objectives of studies. To apply for an amendment to a certificate of registration to add select agents or toxins or to change specified activities or locations, an entity must obtain the relevant portion of the registration application package and submit the information requested in the package to the agency that issued the certificate of registration. The package must be submitted to the appropriate address specified in the package.

(e) In response to an application to the HHS Secretary for a certificate of registration or amendment for select agents and toxins, the HHS Secretary will issue a certificate of registration or amendment if it is determined that the stated activities would be lawful (based on information submitted by the applicant or otherwise obtained by the HHS Secretary) and meet the requirements of this part. Otherwise, the application for a certificate of registration or amendment will be denied. The HHS Secretary will issue a certificate of registration or amendment for an overlap select agent or toxin only if the USDA Secretary concurs that the requirements for obtaining a certificate of registration or amendment under 9 CFR part 121 have been met. The determination of whether a certificate of registration or amendment will be granted may be contingent upon inspection or submission of additional information.

(f) A certificate of registration will cover activities at only one general physical location (a building or a complex of buildings at a single mailing address).

(g) Unless terminated sooner in accordance with this paragraph, a certificate of registration will be valid for up to three years. To obtain a new certificate of registration an entity must submit a new application. (Note: To help ensure timely processing of an application for a certificate of registration or amendment, the applicant should submit the application at least eight weeks prior to the expiration date.)

(1) The HHS Secretary will terminate a certificate of registration based on a determination that the recipient no longer conducts activities covered by the certificate.

(2) Also, the HHS Secretary may terminate a certificate of registration based on a security risk assessment under § 73.8 or failure to comply with the provisions of this part, and may take such action immediately if necessary to protect the public health or safety. Upon such termination, any select agent or toxin in the possession of the entity must be destroyed or transferred as directed by the HHS Secretary.

(h) An entity must provide notice in writing to the HHS Secretary in accordance with § 73.21 at least five business days before destroying a select agent or toxin, if the destruction would be for the purpose of discontinuing activities with a select agent or toxin covered by a certificate of registration. This will allow the HHS Secretary to observe the destruction or take other action as appropriate.

(a) An entity may not possess or use in the United States, receive from outside the United States, or transfer within the United States, any select agent or toxin unless approved by the HHS Secretary or the USDA Secretary based on a security risk assessment by the Attorney General. This paragraph does not apply to Federal, State, or local governmental agencies, but does apply to the Responsible Official and others working for or otherwise acting on behalf of such agencies.

(b) An entity may not provide an individual access to a select agent or toxin and an individual may not access a select agent or toxin, unless the individual is approved by the HHS Secretary or the USDA Secretary, based on a security risk assessment by the Attorney General.

(c) To obtain a security risk assessment under this section, an entity must submit to the Attorney General the information requested for the entity, the Responsible Official, any individual who owns or controls the entity, and any other individuals required to obtain approval under this section. The determinations regarding approval will be made by the agency that is responsible for making determinations regarding the corresponding certificate of registration. An entity will receive prompt notice of action taken in response to a request for approval for the entity, the Responsible Official, and individuals. An individual will receive prompt notice of a denial of approval.

(d) The Attorney General will conduct a security risk assessment on entities and individuals whose identifying information is properly submitted. Based on the security risk assessment, the Attorney General will notify the HHS Secretary if the Attorney General identifies any entity, individual who owns or controls the entity, or any other individual who is:

(1) A restricted person under 18 U.S.C. 175b; or

(2) Reasonably suspected by any Federal law enforcement or intelligence agency of:

(i) Committing a crime specified in 18 U.S.C. 2332b(g)(5);

(ii) Having a knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or

(iii) Being an agent of a foreign power (as defined in 50 U.S.C. 1801).

(e) The HHS Secretary will deny or revoke access to any select agent or toxin to an entity or individual identified by the Attorney General as a restricted person under paragraph (d)(1). The HHS Secretary will deny or revoke access to any select agent or toxin to an entity or individual identified by the Attorney General as meeting the criteria of paragraph (d)(2) unless determined by the HHS Secretary to be warranted in the interest of the public health and safety or national security. For individuals meeting the criteria of paragraph (d)(2) the HHS Secretary may provide a limited approval for a specified time based upon the finding that circumstances warrant such action in the interest of the public health and safety or national security.

(f) Unless a shorter period is granted under paragraph (e) of this section, an approval for an entity or individual under this section will be valid for five years unless terminated sooner. The HHS Secretary may terminate an approval for an entity or an individual based on a request from the entity or individual, a security risk assessment under this section, or a failure to comply with the provisions of this part, and may take such action immediately if necessary to protect the public health and safety, or national security.

(g) The HHS Secretary will request the Attorney General to expedite the review process for an individual and will take action to expedite the HHS Secretary's review process for an individual upon a showing of good cause (e.g., public health or agricultural emergencies, national security, impending expiration of a research grant, a short-term visit by a prominent researcher). To apply for an expedited review, an entity must submit a request in writing in accordance with § 73.21 to the HHS Secretary establishing the need for such action. The HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request.

(a) As a condition of conducting activities regulated under this part, an entity must identify and authorize an individual as the Responsible Official. The Responsible Official may identify one or more individuals, any of whom may serve as the Alternate Responsible Official when the Responsible Official is unavailable. The Responsible Official and all individuals identified to serve as the Alternate Responsible Official must meet all of the qualifications for a Responsible Official. The Responsible Official and all Alternate Responsible Officials must:

(1) Be approved under § 73.8;

(2) Be familiar with the requirements of this part; and

(3) Have authority and responsibility to ensure that the requirements of this part are met, on behalf of the entity.

(b) For purposes of this part, the Alternate Responsible Official acting in the absence of the Responsible Official may conduct all of those activities required under this part to be performed by the Responsible Official.

(c) The Responsible Official is responsible for ensuring compliance with the regulations, including:

(1) Developing and implementing safety, security and emergency response plans in accordance with § 73.10—§ 73.12;

(2) Allowing only approved individuals to have access to select agents or toxins in accordance with § 73.8 and § 73.11;

(3) Providing appropriate training for safety, security and emergency response in accordance with § 73.13;

(4) Transferring select agents or toxins in accordance with § 73.14;

(5) Providing timely notice of any theft, loss, or release of a select agent or toxin in accordance with § 73.13;

(6) Maintaining detailed records of information necessary to give a complete accounting of all activities related to select agents or toxins in accordance with § 73.15.

(7) The reporting of the identification of a select agent or toxin as a result of diagnosis, verification or proficiency testing in accordance with § 73.6.

(a) An entity subject to the provisions of this part, must develop and implement a safety plan. In developing a safety plan, an entity should consider:

(1) The biosafety standards and requirements for BSL 2, 3, or 4 operations, as they pertain to the respective select agents, that are contained in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,” including all appendices except Appendix F. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Post Office Box 371954, Pittsburgh, Pennsylvania, 75250-7954 or call in the Washington, DC metropolitan area 202-512-1800 or outside that area call toll free 1-866-512-1800. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia. This publication is also available on the CDC Web site at http://www.cdc.gov.

(2) The specific requirements for handling toxins found in 29 CFR 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories” and/or 29 CFR 1910.1200, “Hazard Communication,” whichever applies and specific provisions for handling toxins found in Appendix I in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,”

(3) For provisions of the safety plan relating to genetic elements, recombinant nucleic acids and recombinant organisms, the “NIH Guidelines for Research Involving Recombinant DNA Molecules,” (NIH Guidelines). This includes, among other things, provisions regarding risk assessment, physical containment, biological containment, and local review and applies to all recombinant DNA research, regardless of funding. Copies may be obtained from the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia, 30333. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia. The “NIH Guidelines for Research Involving Recombinant DNA Molecules,” is also available on the CDC Web site at http://www.cdc.gov.

(b) The Responsible Official or his or her designee must conduct regular inspections (at least annually) of the laboratory where select agents and toxins are stored or used to ensure compliance with all of the procedures and protocols of the safety plan. The results of these inspections must be documented, and any deficiencies identified during inspections must be corrected.

(c) An entity may not conduct the following experiments unless approved by the HHS Secretary after consultation with experts:

(1) Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.

(2) Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight.

(d) [Reserved]

(a) An entity must develop and implement a security plan establishing policy and procedures that ensure the security of areas containing select agents and toxins. The security plan must be based on a systematic approach in which threats are defined, vulnerabilities are examined, and risks associated with those vulnerabilities are mitigated with a security systems approach.

(b) The plan must:

(1) Describe inventory control procedures, minimal education and experience criteria for those individuals with access to select agents or toxins, physical security, and cyber security;

(2) Contain provisions for routine cleaning, maintenance, and repairs; provisions for training personnel in security procedures; provisions for securing the area (e.g., card access, key pads, locks) and protocols for changing access numbers or locks following staff changes;

(3) Describe procedures for loss or compromise of keys, passwords, combinations, etc.;

(4) Contain procedures for reporting suspicious persons or activities, loss or theft of listed agents or toxins, release of listed agents or toxins, or alteration of inventory records;

(5) Contain provisions for the control of access to containers where listed agents and toxins are stored; and procedures for reporting and removing unauthorized persons;

(6) Contain provisions for ensuring that all individuals with access, including workers and visitors, understand security requirements and are trained and equipped to follow established procedures;

(7) Establish procedures for reporting and removing unauthorized persons; and

(8) Establish procedures for securing the area when individuals approved under § 73.8 are not present (e.g., card access system, key pads, locks), including protocols for changing access numbers or locks following staff changes.

(c) The security plan must be reviewed by the RO at least annually and after any incident.

(d) With respect to areas containing select agents and toxins, the entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security as the provisions below:

(1) Allow unescorted access only to individuals who have been approved under § 73.8 and who are performing a specifically authorized function during hours required to perform the defined job (including delivery to an outside shipping agent for transportation in commerce);

(2) Allow individuals not approved under § 73.8 to conduct routine cleaning, maintenance, repairs, and other non-laboratory functions only when escorted and continually monitored by individuals approved under § 73.8;

(3) Provide for the control of access to containers where select agents and toxins are stored by requiring freezers, refrigerators, cabinets, and other containers where stocks of select agents and toxins are stored to be locked (e.g., card access system, lock boxes) when they are not in the direct view of approved staff, and by using other monitoring measures as needed, such as video surveillance;

(4) Require the inspection of all packages upon entry to and exit from the area;

(5) Establish a protocol for intra-entity transfers, including provisions for ensuring that the packaging, and movement from a laboratory to another laboratory or from a laboratory to a shipping place, is conducted under the supervision of an individual approved under § 73.8;

(6) Require that each approved individual under 73.8 does not share with any other person, his or her unique means (e.g., keycards or passwords) of accessing the area or select agent or toxin;

(7) Require that each individual approved under § 73.8 report any of the following immediately to the Responsible Official:

(i) Any loss or compromise of their keys, passwords, combinations, etc.;

(ii) Any suspicious persons or activities;

(iii) Any loss or theft of select agents or toxins;

(iv) Any release of select agents or toxins; and

(v) Any sign that inventory and use records of select agents or toxins have been altered or otherwise compromised.

(e) The entity must separate areas where select agents and toxins are stored or used from the public areas of the buildings.

(f) Upon termination of the use, a select agent or toxin must be

(1) Securely stored in accordance with the requirements of this section;

(2) Transferred to another registered facility in accordance with § 73.14; or

(3) Destroyed on-site by autoclaving, incineration, or another recognized sterilization or neutralization process.

(a) An entity required to register under this part must develop and implement an emergency response plan that meets the requirements of OSHA Hazardous waste operations and emergency response standard at 29 CFR 1910.120. Nothing in this section is to supersede or preempt the enforcement of the emergency response requirements imposed by the other statute or regulation.

(b) The emergency response plan must be coordinated with any entity-wide plans. The plan must address such events as bomb threats, severe weather (hurricanes, floods), earthquakes, power outages, and other natural disasters or emergencies.

(c) The emergency response plan must address the following:

(1) The hazards associated with the use of the select agents and toxins;

(2) Any hazards associated with response actions that could lead to a spread of a select agent or toxin;

(3) Planning and coordination with outside parties;

(4) Personnel roles, lines of authority, training, and communication;

(5) Emergency recognition and prevention;

(6) Safe distances and places of refuge;

(7) Site security and control;

(8) Evacuation routes and procedures;

(9) Decontamination;

(10) Emergency medical treatment and first aid;

(11) Emergency alerting and response procedures;

(12) Critique of response and follow-up;

(13) Personal protective and emergency equipment; and

(14) Special procedures needed to address the hazards of specific agents.

(a) An entity required to register under this part and falls outside of the OSHA Bloodborne Pathogen Standard 29 CFR 1910.1030(a) must provide information and training on safety and security for working with select agents and toxins to each individual approved for access under § 73.8 and each unapproved individual working in, or visiting, areas where select agents and toxins are handled or stored. The information and training must meet the requirements of this section and must ensure that all individuals who work in, or visit, the areas understand the hazards of select agents and toxins present in the area.

(b) The entity must provide information and training at the time of an individual's initial assignment to a work area where select agents or toxins are present and prior to assignments involving new exposure situations. The entity must provide refresher training annually.

(c) The Responsible Official must provide appropriate training in safety, containment, and security to all individuals with access to areas where select agents and toxins are handled or stored.

(d) In lieu of initial training for those individuals already involved in handling select agents or toxins, the Responsible Official may certify in writing that the individual has the required knowledge, skills, and abilities to safely carry out the duties and responsibilities.

(e) The entity must ensure that each individual with access to areas where select agents or toxins are handled or stored received and understood the training required by this section unless certified under paragraph (d) of this section. The entity must record the identity of the individual trained, the date of training, and the means used to verify that the employee understood the training.

A select agent or toxin may not be transferred from one entity to another entity within the United States (regardless of whether the transfer is interstate or intrastate), or received by an entity in the United States from an entity outside the United States, unless:

(a) The sender:

(1) Has a certificate of registration that covers the transfer of the particular select agent or toxin to be transferred,

(2) Meets the exemption requirements under § 73.6 (a) for the particular select agent or toxin to be transferred, or

(3) Is transferring the select agent or toxin from outside the United States (and all import requirements are met);

(b) The recipient has a certificate of registration that includes the particular select agent or toxin to be transferred;

(c) Prior to the transfer, the recipient and sender completes CDC Form EA-101, and the recipient submits to the HHS Secretary in accordance with § 73.21 a completed CDC Form EA-101.

(d) CDC has authorized the transfer based on the finding that the recipient has a certificate of registration covering the transfer of the select agent or toxin;

(e) The sender complies with all applicable laws concerning packaging and shipping;

(f) The Responsible Official of the recipient provides a completed paper copy or facsimile transmission of CDC Form EA-101 to the sender and to the HHS Secretary within 2 business days of receipt of the select agent or toxin; and

(g) The recipient immediately reports to the HHS Secretary if the select agent or toxin has not been received within 48 hours after the expected delivery time, or if the package received containing select agents or toxins has been leaking or was otherwise damaged.

(h) When the select agents or toxins are consumed or destroyed after a transfer, the recipient must within five business days report such fact to the HHS Secretary in accordance with § 73.21 on a CDC Form EA-101.

The Responsible Official must maintain complete records relating to the activities covered by this Part. Such records include:

(a) An entity required to register under this part must maintain an up-to-date, accurate list of the individuals approved under § 73.8 for access to select agents and toxins.

(b) The entity must maintain an accurate, current inventory of each select agent and toxin held. The inventory records must include the following information for each select agent and toxin:

(1) The name, characteristics, and source data;

(2) The quantity held on the date of the first inventory (toxins only);

(3) The quantity acquired, the source, and date of acquisition;

(4) The quantity, volume, or mass destroyed or otherwise disposed of and the date of each such action;

(5) The quantity used and date(s) of the use (toxins only);

(6) The quantity transferred, the date of transfer, and individual to whom it was transferred (this includes transfers within an entity when the sender and the recipient are covered by the same certificate of registration);

(7) The current quantity held (toxins only);

(8) Any select agent or toxin lost, stolen, or otherwise unaccounted for; and

(9) A written explanation of any discrepancies.

(c) The entity must maintain the following records:

(1) For access to the select agents or toxins:

(i) The name of each individual who has accessed any select agent or toxin;

(ii) The select agent or toxin used;

(iii) The date when the select agent or toxin was removed, if removed from long-term storage or holdings for stock cultures;

(iv) The quantity removed (toxins only);

(v) The date the select agent or toxin was returned to the long-term storage or holdings for stock cultures; and

(vi) The quantity returned (toxins only);

(2) For access to the area where select agents are used or stored:

(i) The name of each individual who has accessed the area;

(ii) The date and time the individual entered the area;

(iii) The date and time the individual left the area; and

(iv) For individuals not approved under § 73.8, the individual approved under § 73.8 who accompanied the unapproved individual into the area.

(d) The entity must implement a system to ensure that all records and databases created under paragraphs (b) and (c) of this section are accurate, and that the authenticity of records may be verified.

(e) The entity must create a record concerning inspections conducted under § 73.10(b).

(f) Safety, security, and emergency response plans.

(g) Training records.

(h) Transfer documents (CDC Form EA-101) and permits.

(i) Safety and security incident reports.

(j) The entity must maintain all records created under this part for three years.

The HHS Secretary, without prior notification and with or without cause, shall be allowed to inspect any site at which activities regulated by this part are conducted and shall be allowed to inspect and copy any records relating to the activities covered by this part.

(a) Upon discovery of a theft or loss of a select agent or toxin, an entity required to register under this part must immediately notify the HHS Secretary and State and local law enforcement. The notification must be reported to the HHS Secretary by either telephone, facsimile, or e-mail in accordance with § 73.21.

(b) Thefts or losses must be reported whether the select agent or toxin is subsequently recovered or the responsible parties are identified.

(c) When reporting a theft or loss, the entity must provide the following information:

(1) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information);

(2) An estimate of the quantity lost or stolen;

(3) An estimate of the time during which the theft or loss occurred; and

(4) The location (building, room) from which the theft or loss occurred.

(d) The entity shall immediately notify the HHS Secretary and State and local public health agencies of any release of a select agent or toxin causing occupational exposure or release outside of the primary containment barriers. The report must be made to the HHS Secretary by telephone, facsimile, or e-mail in accordance with § 73.21.

(e) When reporting a release, the entity must provide the following information:

(1) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information);

(2) An estimate of the quantity released;

(3) The time and duration of the release;

(4) The environment into which the release occurred (e.g., in building or outside of building, waste system);

(5) The location (building, room) from which the release occurred;

(6) The number of individuals potentially exposed at the facility.

(7) Actions taken to respond to the release; and

(8) Hazards posed by the release.

(f) Within seven calendar days of theft, loss, or release, the entity must submit a follow-up report in writing to the HHS Secretary on CDC Form 0.1316 in accordance with § 73.21.

An entity may obtain review of a decision denying or revoking a certificate of registration under § 73.7 and the affected entity or individual may obtain review of a decision denying or revoking approval under § 73.8 by requesting such review in writing within 30 calendar days after the adverse decision. The request for review must state the factual basis for the review, which will be carried out in accordance with 42 U.S.C. 262a(e)(7). Where the adverse decision is in whole or in part based upon notification by the Attorney General under 42 U.S.C. 262a (e)(3), the request for review will be forwarded to the Attorney General for the Attorney General's review and final notification to the HHS Secretary.

(a) The Inspector General of the Department of Health and Human Services is delegated authority to conduct investigation and to impose civil money penalties against any individual or entity in accordance with regulations in 42 CFR part 1003 for violation of the regulations in this part, as authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). The delegation of authority includes all powers contained in section 6 of the Inspector General Act of 1978 (5 U.S.C. App.).

(b) The administrative law judges in, assigned to, or detailed to the Departmental Appeals Board (DAB) have been delegated authority to conduct hearings and to render decisions with respect to the imposition of civil money penalties, as authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). This delegation includes, but is not limited to, the authority to administer oaths and affirmations, to subpoena witnesses and documents, to examine witnesses, to exclude or receive and give appropriate weight to materials and testimony offered as evidence, to make findings of fact and conclusions of law, and to determine the civil money penalties to be imposed.

(c) The DAB of the Department of Health and Human Services is delegated authority to make final determinations with respect to the imposition of civil money penalties for violations of the regulations of this part.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188) provides specific criminal penalties for violation of provisions of this part. This is in addition to any other criminal penalties that would apply for violation of provisions of this part.

(a) CDC forms referred to in this part, including registration application packages, may be obtained on the Select Agent Program Web site at http://www.cdc.gov, or by requesting them in writing from the Select Agent Program, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Mail Stop E 79, Atlanta, Georgia 30333. Forms (including any required attachments) must be submitted in accordance with the instructions on the form.

(b) Applications, requests, notifications, and other information required to be submitted to the HHS Secretary in writing, but not required to be on a form, unless otherwise specified, must be submitted to the Select Agent Program, Center for Disease Control and Prevention, 1600 Clifton Road, NE., Mail Stop E 79, Atlanta, Georgia 30333, or by e-mail at lrsat@cdc.gov.

(c) Information not required to be submitted to the HHS Secretary on a form may be submitted to the Select Agent Program, Center for Disease Control and Prevention, 1600 Clifton Road, NE., Mail Stop E 79, Atlanta, Georgia 30333, or by e-mail at lrsat@cdc.gov.

(d) If an application or request submitted to the HHS Secretary is incomplete or additional information is needed to allow the decision maker to make a determination, the HHS Secretary will notify the applicant or requester in writing of the deficiency and request additional information. If the applicant or requester fails to respond within 30 calendar days (or within such time period agreed upon by the applicant or requester and the HHS Secretary) the application or request will be deemed abandoned.

(e) You may request forms or other information from the USDA at the following address: APHIS, Veterinary Services, National Center for Import and Export, 4700 River Road Unit 40, Riverdale, MD 20737-1231.

(a) The purpose of these regulations is to implement the provisions of section 979 of the Consumer-Patient Radiation Health and Safety Act of 1981, 42 U.S.C. 10004, which requires the establishment by the Secretary of Health and Human Services of standards for the accreditation of programs for the education of certain persons who administer radiologic procedures and for the credentialing of such persons.

(b) Section 979 requires the Secretary, after consultation with specified Federal agencies, appropriate agencies of States, and appropriate professional organizations, to promulgate by regulation the minimum standards described above. These standards distinguish between the occupations of (1) radiographer, (2) dental hygienist, (3) dental assistant, (4) nuclear medicine technologist, and (5) radiation therapy technologist. In the interest of public safety and to prevent the hazards of improper use of medical radiation identified by Congress in its determination of the need for standards, the Secretary is also authorized to prepare standards for other occupational groups utilizing ionizing and non-ionizing radiation as he/she finds appropriate. However, the standards set out below are limited to the five occupational groups listed above, utilizing ionizing radiation. Nothing in these accreditation standards is intended to discriminate against proprietary schools.

All terms not defined herein shall have the meaning given them in the Act. As used in this part:

Accreditation, as applied to an educational program, means recognition, by a State government or by a nongovernmental agency or association, of a specialized program of study as meeting or exceeding certain established qualifications and educational standards. As applied to a health care or educational institution, accreditation means recognition, by a State government or by a nongovernmental agency or association, of the institution as meeting or exceeding certain established standards or criteria for that type of institution.

Act means the Consumer-Patient Radiation Health and Safety Act of 1981, 42 U.S.C. 10001-10008.

Continuing competency means the maintenance of knowledge and skills and/or demonstrated performance that are adequate and relevant to professional practice needs.

Credentialing means any process whereby a State Government or nongovernmental agency or association grants recognition to an individual who meets certain predetermined qualifications.

Dental hygienist means a person licensed by the State as a dental hygienist.

Dental assistant means a person other than a dental hygienist who assists a dentist in the care of patients.

Educational program means a set of formally structured activities designed to provide students with the knowledge and skills necessary to enter an occupation, with evaluation of student performance according to predetermined objectives.

Energized laboratory means any facility which contains equipment that generates ionizing radiation. This does not include facilities for training students when the equipment is not powered to emit ionizing radiation, e.g., practice in setting controls and positioning of patients.

Formal training means training or education, including either didactic or clinical practicum or both, which has a specified objective, planned activities for students, and suitable methods for measuring student attainment, and which is offered, sponsored, or approved by an organization or institution which is able to meet or enforce these criteria.

Ionizing radiation means any electromagnetic or particulate radiation (X-rays, gamma rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles) which interacts with atoms to produce ion pairs in matter.

Licensed practitioner means a licensed doctor of medicine, osteopathy, dentistry, podiatry, or chiropractic.

Licensure means the process by which an agency of State government grants permission to persons meeting predetermined qualifications to engage in an occupation.

Nuclear medicine technologist means a person other than a licensed practitioner who prepares and administers radio-pharmaceuticals to human beings and conducts in vivo or in vitro detection and measurement of radioactivity for medical purposes.

Permit means an authorization issued by a State for specific tasks or practices rather than the entire scope of practice in an occupation.

Radiation therapy technologist means a person other than a licensed practitioner who utilizes ionizing radiation-generating equipment for therapeutic purposes on human subjects.

Radiographer means an individual other than a licensed practitioner who (1) performs, may be called upon to perform, or who is licensed to perform a comprehensive scope of diagnostic radiologic procedures employing equipment which emits ionizing radiation, and (2) is delegated or exercises responsibility for the operation of radiation-generating equipment, the shielding of patient and staff from unnecessary radiation, the appropriate exposure of radiographs, or other procedures which contribute to any significant extent to the site or dosage of ionizing radiation to which a patient is exposed. Radiographers are distinguished from personnel whose use of diagnostic procedures is limited to a few specific body sites and/or standard procedures, from those personnel in other clinical specialties who may occasionally be called upon to assist in diagnostic radiology, and from those technicians or assistants whose activities do not, to any significant degree, determine the site or dosage of radiation to which a patient is exposed.

Radiologist means a physician certified in radiology by the American Board of Radiology or the American Osteopathic Board of Radiology.

(a) Federal Government. Except as provided in section 983 of the Act, the credentialing standards set out in the Appendixes to this part apply to those individuals who administer or propose to administer radiologic procedures, in each department, agency and instrumentality of the Federal Government as follows:

(1) Radiographer Standards apply to all individuals who are radiographers as defined in § 75.2 and who are not practitioners excepted by the Act.

(2) Nuclear Medicine Technologist Standards apply to all individuals who are nuclear medicine technologists as defined in § 75.2, who perform in vivo nuclear medicine procedures, and who are not practitioners excepted by the Act. For purposes of this Act, any administration of radiopharmaceuticals to human beings is considered an in vivo procedure.

(3) Radiation Therapy Technologist Standards apply to all individuals who perform radiation therapy and who are not practitioners excepted by the Act.

(4) Dental Hygienist Standards apply to all dental hygienists who perform dental radiography.

(5) Dental Assistant Standards apply to all dental assistants who perform dental radiography.

(6) The following persons are deemed to have met the requirements of these standards:

(i) Persons employed by the Federal government as radiologic personnel prior to the effective date of this regulation and who show evidence of current or fully satisfactory performance or certification of such from a licensed practitioner:

(ii) Uniformed military personnel who receive radiologic training from or through the Armed Forces of the United States and who meet standards established by the Department of Defense or components thereof, provided that those standards are determined by such Department or component to offer equivalent protection of patient health and safety:

(iii) Foreign national employed by the Federal government in positions outside of the United States who show evidence of training, experience, and competence determined by the employing agency to be equally protective of patients health and safety; and

(iv) Persons first employed by the Federal government as radiologic personnel after the effective date of this regulation who (a) received training from institutions in a State or foreign jurisdiction which did not accredit training in that particular field at the time of graduation, or (b) practiced in a State or foreign jurisdiction which did not license that particular field or which did not allow special eligibility to take a licensure examination for those who did not graduate from an accredited educational program; provided that such persons show evidence of training, experience, and competence determined by the Office of Personnel Management or the employing agency to be equally protective of patient health and safety.

(7) The following persons are exempted from these standards:

(i) Persons who are trained to perform, or perform, covered radiologic procedures in emergency situations which preclude use of fully qualified personnel; and

(ii) Students in approved training programs.

(8) A department, agency, or instrumentality of the Federal government may, after consultation with the Secretary, use alternative criteria which it determines would offer equivalent protection of patient health and safety.

(b) States. The States may, but are not required to, adopt standards for accreditation and credentialing that are consistent with the standards set out in the appendixes to this part.