9 C.F.R. PART 121—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
Title 9 - Animals and Animal Products
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.
Source: 70 FR 13284, Mar. 18, 2005, unless otherwise noted.
Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Attorney General. The Attorney General of the United States or any person authorized to act for the Attorney General. Biological agent. 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: (1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; (2) Deterioration of food, water, equipment, supplies, or material of any kind; or (3) Deleterious alteration of the environment. Centers for Disease Control and Prevention (CDC). The Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Diagnosis. The analysis of specimens for the purpose of identifying or confirming the presence or characteristics of a select agent or toxin, provided that such analysis is directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products. Entity. Any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity. HHS Secretary. The Secretary of the Department of Health and Human Services or his or her designee, unless otherwise specified. HHS select agent and/or toxin. A biological agent or toxin listed in 42 CFR 73.3. Import. To move into, or the act of movement into, the territorial limits of the United States. Interstate. From one State into or through any other State, or within the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States. Overlap select agent and/or toxin. A biological agent or toxin that is listed in §121.4 and 42 CFR 73.4. Permit. A written authorization by the Administrator to import or move interstate select agents or toxins, under conditions prescribed by the Administrator. Proficiency testing. The process of determining the competency of an individual or laboratory to perform a specified test or procedure. Responsible official. The individual designated by an entity with the authority and control to ensure compliance with the regulations in this part. Select agent and/or toxin. Unless otherwise specified, all of the biological agents or toxins listed in §§121.3 and 121.4. Specimen. Samples of material from humans, animals, plants, or the environment, or isolates or cultures from such samples, for diagnosis, verification, or proficiency testing. State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States. Toxin. 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: (1) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or (2) Any poisonous isomer or biological product, homolog, or derivative of such a substance. United States. All of the States. USDA. The U.S. Department of Agriculture. Verification. The demonstration of obtaining established performance (e.g., accuracy, precision, and the analytical sensitivity and specificity) specifications for any procedure used for diagnosis. VS. The Veterinary Services Programs of the Animal and Plant Health Inspection Service. VS select agent and/or toxin. A biological agent or toxin listed in §121.3. This part implements the provisions of the Agricultural Bioterrorism Protection Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. The biological agents and toxins listed in this part have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. Overlap select agents and toxins are subject to regulation by both APHIS and CDC. (a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to animal health or to animal products. (b) VS select agents and toxins: African horse sickness virus; African swine fever virus; Akabane virus; Avian influenza virus (highly pathogenic); Bluetongue virus (exotic); Bovine spongiform encephalopathy agent; Camel pox virus; Classical swine fever virus; Cowdria ruminantium (Heartwater); Foot-and-mouth disease virus; Goat pox virus; Japanese encephalitis virus; Lumpy skin disease virus; Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1); Menangle virus; Mycoplasma capricolum/M. F38/M. mycoides capri (contagious caprine pleuropneumonia); Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia); Newcastle disease virus (velogenic); Peste des petits ruminants virus; Rinderpest virus; Sheep pox virus; Swine vesicular disease virus; Vesicular stomatitis virus (exotic). (c) Genetic elements, recombinant nucleic acids, and recombinant organisms: (1) Nucleic acids that can produce infectious forms of any of the select agent viruses listed in paragraph (b) of this section.1 1 The importation and interstate movement of VS select agents or toxins listed in paragraphs (c)(1) through (c)(3) of this section may be subject to the permit requirements under part 122 of this subchapter. (2) Recombinant nucleic acids that encode for the functional forms of any toxin listed in paragraph (b) of this section if the nucleic acids: (i) Can be expressed in vivo or in vitro; or (ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro. (3) VS select agents and toxins listed in paragraph (b) of this section that have been genetically modified. (d) VS select agents or toxins that meet any of the following criteria are excluded from the requirements of this part: (1) Any VS select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. (2) Nonviable VS select agents or nonfunctional VS toxins.2 2 However, the importation and interstate movement of these nonviable select agents may be subject to the permit requirements under part 122 of this subchapter. (e) An attenuated strain of a VS select agent or toxin may be excluded from the requirements of this part based upon a determination that the attenuated strain does not pose a severe threat to animal health or to animal products. (1) To apply for an exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification of the applicant. Exclusions will be published periodically in the notice section of the (2) If an excluded attenuated strain is subjected to any manipulation that restores or enhances its virulence, the resulting select agent or toxin will be subject to the requirements of this part. (3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an exclusion application. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. (f) Any VS select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that: (1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process. (2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin. (3) The Federal law enforcement agency reports the seizure of the select agent or toxin to APHIS or CDC. (i) The seizure of any of the following VS select agents and toxins must be reported within 24 hours by telephone, facsimile, or e-mail: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic), bovine spongiform encephalopathy agent, classical swine fever virus, foot-and-mouth disease virus, Newcastle disease virus (velogenic), rinderpest virus, and swine vesicular disease virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the select agent or toxin. (ii) For all other VS select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin. (iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years. (4) The Federal law enforcement agency reports the final disposition of the select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years. (a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. (b) Overlap select agents and toxins:
Bacillus anthracis; Botulinum neurotoxins; Botulinum neurotoxin producing species of Clostridium; Brucella abortus; Brucella melitensis; Brucella suis; Burkholderia mallei; Burkholderia pseudomallei; Clostridium perfringens epsilon toxin; Coccidioides immitis; Coxiella burnetii; Eastern equine encephalitis virus; Francisella tularensis; Hendra virus; Nipah virus; Rift Valley fever virus; Shigatoxin; Staphylococcal enterotoxins; T–2 toxin; Venezuelan equine encephalitis virus. (c) Genetic elements, recombinant nucleic acids, and recombinant organisms: (1) Nucleic acids that can produce infectious forms of any of the overlap select agent viruses listed in paragraph (b) of this section.3 3 The importation and interstate movement of overlap select agents or toxins listed in paragraphs (c)(1) through (c)(3) of this section may be subject to the permit requirements under part 122 of this subchapter. (2) Recombinant nucleic acids that encode for the functional forms of any overlap toxin listed in paragraph (b) of this section if the nucleic acids: (i) Can be expressed in vivo or in vitro; or (ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro. (3) Overlap select agents and toxins listed in paragraph (b) of this section that have been genetically modified. (d) Overlap select agents or toxins that meet any of the following criteria are excluded from the requirements of this part: (1) Any overlap select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. (2) Nonviable overlap select agents or nonfunctional overlap toxins.4 4 However, the importation and interstate movement of these nonviable overlap select agents may be subject to the permit requirements under part 122 of this subchapter. (3) Overlap toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor, if the aggregate amount does not, at any time, exceed the following amounts: 0.5 mg of Botulinum neurotoxins, 100 mg of Clostridium perfringens epsilon toxin, 100 mg of Shigatoxin, 5 mg of Staphylococcal enterotoxins, and 1,000 mg of T–2 toxin. (e) An attenuated strain of an overlap select agent or toxin may be excluded from the requirements of this part based upon a determination that the attenuated strain does not pose a severe threat to public health and safety, to animal health, or to animal products. (1) To apply for an exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification of the applicant. Exclusions will be published periodically in the notice section of the (2) If an excluded attenuated strain is subjected to any manipulation that restores or enhances its virulence, the resulting overlap select agent or toxin will be subject to the requirements of this part. (3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an exclusion application. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. (f) Any overlap select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that: (1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process. (2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin. (3) The Federal law enforcement agency reports the seizure of the overlap select agent or toxin to APHIS or CDC. (i) The seizure of any of the following overlap select agents and toxins must be reported within 24 hours by telephone, facsimile, or e-mail: Bacillus anthracis, Botulinum neurotoxins, Brucella melitensis, Francisella tularensis, Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan equine encephalitis virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the overlap select agent or toxin. (ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin. (iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years. (4) The Federal law enforcement agency reports the final disposition of the overlap select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years. (a) Diagnostic laboratories and other entities that possess, use, or transfer a VS select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that: (1) Unless directed otherwise by the Administrator, within 7 calendar days after identification, the agent or toxin is transferred in accordance with §121.16 or destroyed on-site by a recognized sterilization or inactivation process; (2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and (3) The identification of the agent or toxin is reported to APHIS or CDC. (i) The identification of any of the following select agents and toxins must be immediately reported by telephone, facsimile, or e-mail: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic), bovine spongiform encephalopathy agent, classical swine fever virus, foot-and-mouth disease virus, Newcastle disease virus (velogenic), rinderpest virus, and swine vesicular disease virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after identification. (ii) For all other VS select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after identification. (iii) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas. (iv) A copy of APHIS/CDC Form 4 must be maintained for 3 years. (b) Diagnostic laboratories and other entities that possess, use, or transfer a VS select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that: (1) Unless directed otherwise by the Administrator, within 90 calendar days of receipt, the agent or toxin is transferred in accordance with §121.16 or destroyed on-site by a recognized sterilization or inactivation process; (2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and (3) The identification of the agent or toxin, and its derivative, is reported to APHIS or CDC. To report the identification of a select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years. (c) Diagnostic reagents and vaccines that are, bear, or contain VS select agents or toxins that are produced at USDA diagnostic facilities will be exempt from the requirements of this part. (d) Unless the Administrator by order determines that additional regulation is necessary to protect animal health or animal products, products that are, bear, or contain VS select agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to: (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); (2) Section 351 of Public Health Service Act (42 U.S.C. 262); (3) The Virus-Serum-Toxin Act (21 U.S.C. 151–159); or (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131 et seq.). (e) The Administrator may exempt from the requirements of this part an experimental product that is, bears, or contains a VS select agent or toxin if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal health or animal products. To apply for an exemption, an individual or entity must submit APHIS/CDC Form 5. A written decision granting or denying the exemption will be issued. The applicant must notify APHIS when an authorization for an investigation no longer exists. This exemption automatically terminates when such authorization is no longer in effect. (f) In addition to the exemptions provided in paragraphs (a) through (e) of this section, the Administrator may grant a specific exemption upon a showing of good cause and upon his or her determination that such exemption is consistent with protecting animal health or animal products. An individual or entity may request in writing an exemption from the requirements of this part. If granted, such exemptions are valid for a maximum of 3 years; thereafter, an individual or entity must request a new exemption. If a request for exemption is denied, an individual or entity may request reconsideration in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. (a) Clinical or diagnostic laboratories and other entities that possess, use, or transfer an overlap select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that: (1) Unless directed otherwise by the Administrator or the HHS Secretary, within 7 calendar days after identification, the agent or toxin is transferred in accordance with §121.16 or 42 CFR 73.16 or destroyed on-site by a recognized sterilization or inactivation process; (2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and (3) The identification of the agent or toxin is reported to APHIS or CDC. (i) The identification of any of the following overlap select agents and toxins must be immediately reported by telephone, facsimile, or e-mail: Bacillus anthracis, Botulinum neurotoxins, Brucella melitensis, Francisella tularensis, Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan equine encephalitis virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after identification. (ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after identification. (iii) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas. (iv) A copy of APHIS/CDC Form 4 must be maintained for 3 years. (b) Clinical or diagnostic laboratories and other entities that possess, use, or transfer an overlap select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that: (1) Unless directed otherwise by the Administrator or the HHS Secretary, within 90 days of receipt, the agent or toxin is transferred in accordance with §121.16 or 42 CFR 73.16 or destroyed on-site by a recognized sterilization or inactivation process; (2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and (3) The identification of the agent or toxin, and its derivative, is reported to APHIS or CDC. To report the identification of an overlap select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 calendar days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years. (c) Unless the Administrator by order determines that additional regulation of a specific product is necessary to protect animal health or animal products, products that are, bear, or contain overlap select agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to: (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); (2) Section 351 of Public Health Service Act (42 U.S.C. 262); (3) The Virus-Serum-Toxin Act (21 U.S.C. 151–159); or (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131 et seq.). (d) After consultation with the HHS Secretary, the Administrator may exempt from the requirements of this part an investigational product that is, bears, or contains an overlap select agent or toxin if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal health or animal products. (1) To apply for an exemption, an individual or entity must submit APHIS/CDC Form 5. (2) The Administrator will make a determination regarding an exemption within 14 calendar days after receipt of the application and notification that the investigation has been authorized under a Federal law. A written decision granting or denying the exemption will be issued. (3) The applicant must notify APHIS or CDC when an authorization for an investigation no longer exists. This exemption automatically terminates when such authorization is no longer in effect. (e) The Administrator may exempt an individual or entity from the requirements of this part for 30 calendar days if it is necessary to respond to a domestic or foreign agricultural emergency involving an overlap select agent or toxin. The Administrator may extend the exemption once for an additional 30 days. An individual or entity may apply for this exemption by submitting APHIS/CDC Form 5. A written decision granting or denying the exemption will be issued. (f) Upon request of the Secretary of Health and Human Services, the Administrator may exempt an individual or entity from the requirements of this part for 30 calendar days if the Secretary of Health and Human Services has granted an exemption for a public health emergency involving an overlap select agent or toxin. The Administrator may extend the exemption once for an additional 30 days. (a) Unless exempted under §121.5, an individual or entity shall not possess, use, or transfer any VS select agent or toxin without a certificate of registration issued by the Administrator. Unless exempted under §121.6 or 42 CFR 73.6, an individual or entity shall not possess, use, or transfer any overlap select agent or toxin without a certificate of registration issued by the Administrator and the HHS Secretary. (b) As a condition of registration, each entity must designate an individual to be its responsible official. While most registrants are likely to be entities, in the event that an individual applies for and is granted a certificate of registration, the individual will be considered the responsible official. (c)(1) As a condition of registration, the following must be approved by the Administrator or the HHS Secretary based on a security risk assessment by the Attorney General: (i) The individual or entity; (ii) The responsible official; and (iii) Unless otherwise exempted under this section, any individual who owns or controls the entity. (2) Federal, State, or local governmental agencies, including public accredited academic institutions, are exempt from the security risk assessments for the entity and the individual who owns or controls such entity. (3) An individual will be deemed to own or control an entity under the following conditions:5 5 These conditions may apply to more than one individual. (i) For a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity. (ii) For entities other than institutions of higher education, an individual will be deemed to own or control the entity if the individual: (A) Owns 50 percent or more of the entity, or is a holder or owner of 50 percent or more of its voting stock; or (B) Is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity. (4) An entity will be considered to be an institution of higher education if it is an institution of higher education as defined in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or is an organization described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501(c)(3)). (5) To obtain a security risk assessment, an individual or entity must submit the information necessary to conduct a security risk assessment to the Attorney General. (d) To apply for a certificate of registration for only VS select agents or toxins, or for VS and PPQ select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS. To apply for a certificate of registration for overlap select agents or toxins, overlap select agents or toxins and any combination of PPQ or VS select agents or toxins, or HHS select agents or toxins and any combination of PPQ or VS select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS or CDC, but not both. (e) Prior to the issuance of a certificate of registration, the responsible official must promptly provide notification of any changes to the application for registration by submitting the relevant page(s) of the registration application. (f) The issuance of a certificate of registration may be contingent upon inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part. (g) A certificate of registration will be valid for one physical location (a room, a building, or a group of buildings) where the responsible official will be able to perform the responsibilities required in this part, for specific select agents or toxins, and for specific activities. (h) A certificate of registration may be amended to reflect changes in circumstances (e.g., replacement of the responsible official or other personnel changes, changes in ownership or control of the entity, changes in the activities involving any select agents or toxins, or the addition or removal of select agents or toxins). (1) Prior to any change, the responsible official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application.6 6 Depending on the change, a security risk assessment by the Attorney General may also be required (e.g., replacement of the responsible official, changes in ownership or control of the entity, new researchers or graduate students, etc.) (2) The responsible official will be notified in writing if an application to amend a certificate of registration has been approved. Approval of an amendment may be contingent upon an inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part. (3) No change may be made without such approval. (i) An entity must immediately notify APHIS or CDC if it loses the services of its responsible official. In the event that an entity loses the services of its responsible official, an entity may continue to possess or use select agents or toxins only if it appoints as the responsible official another individual who has been approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General and who meets the requirements of this part. (j) A certificate of registration will be terminated upon the written request of the entity if the entity no longer possesses or uses any select agents or toxins and no longer wishes to be registered. (k) A certificate of registration will be valid for a maximum of 3 years. (a) An application may be denied or a certificate of registration revoked or suspended if: (1) The individual or entity, the responsible official, or an individual who owns or controls the entity is within any of the categories described in 18 U.S.C. 175b; (2) The individual or entity, the responsible official, or an individual who owns or controls the entity is reasonably suspected by any Federal law enforcement or intelligence agency of: (i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or (ii) 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; (3) The individual or entity does not meet the requirements of this part;7 7 If registration is denied for this reason, we may provide technical assistance and guidance. (4) It is determined that such action is necessary to protect animal health or animal products. (b) Upon revocation or suspension of a certificate of registration, the individual or entity must: (1) Immediately stop all use of each select agent or toxin covered by the revocation or suspension order; (2) Immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release; and (3) Comply with all disposition instructions issued by the Administrator for each select agent or toxin covered by the revocation or suspension. (c) Denial of an application for registration and revocation of registration may be appealed under §121.20. However, any denial of an application for registration or revocation of a certificate of registration will remain in effect until a final agency decision has been rendered. (a) An individual or entity required to register under this part must designate an individual to be the responsible official. The responsible official must: (1) Be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General; (2) Be familiar with the requirements of this part; (3) Have authority and responsibility to act on behalf of the entity; (4) Ensure compliance with the requirements of this part; and (5) Ensure that annual inspections are conducted for each laboratory where select agents or toxins are stored or used in order to determine compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected. (b) An entity may designate one or more individuals to be an alternate responsible official, who may act for the responsible official in his/her absence. These individuals must have the authority and control to ensure compliance with the regulations when acting as the responsible official. (c) The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification. (1) The identification of any of the following select agents or toxins must be immediately reported by telephone, facsimile, or e-mail: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic), Bacillus anthracis, Botulinum neurotoxins, bovine spongiform encephalopathy agent, Brucella melitensis, classical swine fever virus, foot-and-mouth disease virus, Francisella tularensis, Hendra virus, Newcastle disease virus (velogenic), Nipah virus, Rift Valley fever virus, rinderpest virus, swine vesicular disease virus, and Venezuelan equine encephalitis virus. The final disposition of the agent or toxin must be reported by submission of APHIS/CDC Form 4 within 7 calendar days after identification. A copy of the completed form must be maintained for 3 years. (2) To report the identification and final disposition of any other select agent or toxin, APHIS/CDC Form 4 must be submitted within 7 calendar days after identification. A copy of the completed form must be maintained for 3 years. (3) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas. (d) The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for proficiency testing. To report the identification and final disposition of a select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 calendar days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years. (a) An individual or entity required to register under this part 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 Administrator or the HHS Secretary following a security risk assessment by the Attorney General. (b) An individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin (e.g., carries, uses, or manipulates) or the ability to gain possession of a select agent or toxin. (c) Each individual with access to select agents or toxins must have the appropriate education, training, and/or experience to handle or use such agents or toxins. (d) To apply for access approval, each individual must submit the information necessary to conduct a security risk assessment to the Attorney General. (e) An individual's security risk assessment may be expedited upon written request by the responsible official and a showing of good cause (e.g., public health or agricultural emergencies, national security, or a short-term visit by a prominent researcher). A written decision granting or denying the request will be issued. (f) An individual's access approval for VS select agents or toxins may be denied, limited, or revoked if: (1) The individual is within any of the categories described in 18 U.S.C. 175b; (2) The individual is reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); 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 being an agent of a foreign power as defined in 50 U.S.C. 1801; or (3) It is determined that such action is necessary to protect animal health or animal products. (g) For overlap select agents or toxins, an individual's access approval will be denied or revoked if the individual is within any of the categories described in 18 U.S.C. 175b. An individual's access approval may be denied, limited, or revoked for the reasons set forth in paragraphs (f)(2) through (f)(3) of this section. (h) An individual may appeal the Administrator's decision to deny, limit, or revoke access approval under §121.20. (i) Access approval is valid for a maximum of 5 years. (j) The responsible official must immediately notify APHIS or CDC when an individual's access to select agents or toxins is terminated by the entity and the reasons therefore. (a) An individual or entity required to register under this part must develop and implement a written security plan. The security plan must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release. (b) The security plan must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the risk of the select agent or toxin, given its intended use. The security plan must be submitted upon request. (c) The security plan must: (1) Describe procedures for physical security, inventory control, and information systems control; (2) Contain provisions for the control of access to select agents and toxins; (3) Contain provisions for routine cleaning, maintenance, and repairs; (4) Establish procedures for removing unauthorized or suspicious persons; (5) Describe procedures for addressing loss or compromise of keys, passwords, combinations, etc. and protocols for changing access numbers or locks following staff changes; (6) Contain procedures for reporting unauthorized or suspicious persons or activities, loss or theft of select agents or toxins, release of select agents or toxins, or alteration of inventory records; and (7) Contain provisions for ensuring that all individuals with access approval from the Administrator or the HHS Secretary understand and comply with the security procedures. (d) An individual or entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security: (1) Allow access only to individuals with access approval from the Administrator or the HHS Secretary; (2) Allow individuals not approved for access by the Administrator or the HHS Secretary to conduct routine cleaning, maintenance, repairs, and other activities not related to select agents or toxins only when continuously escorted by an approved individual; (3) Provide for the control of select agents and toxins by requiring freezers, refrigerators, cabinets, and other containers where select agents or toxins are stored to be secured against unauthorized access (e.g., card access system, lock boxes); (4) Inspect all suspicious packages before they are brought into or removed from an area where select agents or toxins are used or stored; (5) Establish a protocol for intra-entity transfers under the supervision of an individual with access approval from the Administrator or the HHS Secretary, including chain-of-custody documents and provisions for safeguarding against theft, loss, or release; and (6) Require that individuals with access approval from the Administrator or the HHS Secretary refrain from sharing with any other person their unique means of accessing a select agent or toxin (e.g., keycards or passwords); (7) Require that individuals with access approval from the Administrator or the HHS Secretary immediately report any of the following to the responsible official: (i) Any loss or compromise of keys, passwords, combinations, etc.; (ii) Any suspicious persons or activities; (iii) Any loss or theft of select agents or toxins; (iv) Any release of a select agent or toxin; and (v) Any sign that inventory or use records for select agents or toxins have been altered or otherwise compromised; and (8) Separate areas where select agents and toxins are stored or used from the public areas of the building. (e) In developing a security plan, an individual or entity should consider the document entitled, “Laboratory Security and Emergency Response Guidance for Laboratories Working with Select Agents,” in Morbidity and Mortality Weekly Report (December 6, 2002); 51 (No. RR–19):1–6. This document is available on the Internet at http://www.cdc.gov/mmwr. (f) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. (a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use.8 8 Technical assistance and guidance may be obtained by contacting APHIS. (b) The biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards). (c) In developing a biosafety plan, an individual or entity should consider the following: (1) The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document may be obtained from the U.S. Government Printing Office. It is also available on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index.php. (2) The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR 1910.1200 and 1910.1450. (3) The “NIH Guidelines for Research Involving Recombinant DNA Molecules.” This document is available on the Internet at http://www.aphis.usda.gov./programs/ag_selectagent/index.php. (d) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. 9 For guidance, see the NIH publication, “NIH Guidelines for Research Involving Recombinant DNA Molecules.” This document is available on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index.php. (a) An individual or entity may not conduct a restricted experiment with a VS select agent or toxin unless approved by and conducted in accordance with any conditions prescribed by the Administrator. In addition, an individual or entity may not conduct a restricted experiment with an overlap select agent or toxin unless approved by and conducted in accordance with any conditions prescribed by the Administrator and the HHS Secretary. (b) Restricted experiments: (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 toxins lethal for vertebrates at an LD50 <100 ng/kg body weight. (c) The Administrator may revoke approval to conduct any of the experiments in paragraph (b) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part. (d) To apply for approval to conduct any of the experiments in paragraph (b) of this section, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. 10 Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations. (a) An individual or entity required to register under this part must develop and implement a written incident response plan.11 11 Technical assistance and guidance may be obtained by contacting APHIS. (b) The incident response plan must fully describe the entity's response procedures for the theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, etc. The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such agent or toxin. (c) The incident response plan must also contain the following information: (1) The name and contact information (e.g., home and work) for the individual or entity (e.g., responsible official, alternate responsible official(s), biosafety officer, etc.); (2) The name and contact information for the building owner and/or manager, where applicable; (3) The name and contact information for tenant offices, where applicable; (4) The name and contact information for the physical security official for the building, where applicable; (5) Personnel roles and lines of authority and communication; (6) Planning and coordination with local emergency responders; (7) Procedures to be followed by employees performing rescue or medical duties; (8) Emergency medical treatment and first aid; (9) A list of personal protective and emergency equipment, and their locations; (10) Site security and control; (11) Procedures for emergency evacuation, including type of evacuation, exit route assignments, safe distances, and places of refuge; and (12) Decontamination procedures. (d) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. (a) An individual or entity required to register under this part must provide information and training on biosafety and security to each individual with access approval from the Administrator or the HHS Secretary before he/she has such access. In addition, an individual or entity must provide information and training on biosafety and security to each individual not approved for access by the Administrator or the HHS Secretary before he/she works in or visits areas where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, etc.). The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins.12 12 For guidance, see the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document is available on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index.php. (b) Refresher training must be provided annually. (c) A record of the training provided to each individual must be maintained. The record must include the name of the individual, the date of training, a description of the training provided, and the means used to verify that the employee understood the training. (a) Except as provided in paragraphs (c) and (d) of this section, a select agent or toxin may only be transferred to individuals or entities registered to possess, use, or transfer that agent or toxin. A select agent or toxin may only be transferred under the conditions of this section and must be authorized by APHIS or CDC prior to the transfer.13 13 The requirements of this section do not apply to transfers within a registered entity (i.e., the sender and the recipient are covered by the same certificate of registration). (b) In addition to any permit required under part 122 of this subchapter, a transfer may be authorized if: (1) The sender: (i) Has at the time of transfer a certificate of registration that covers the particular select agent or toxin to be transferred and meets all the requirements of this part; (ii) Meets the exemption requirements for the particular select agent or toxin to be transferred; or (iii) Is transferring the select agent or toxin from outside of the United States and meets all import requirements. (2) At the time of transfer, the recipient has a certificate of registration that includes the particular select agent or toxin to be transferred and meets all of the requirements of this part. (c) A select agent or toxin that is contained in a specimen for proficiency testing may be transferred without prior authorization from APHIS or CDC provided that, at least 7 calendar days prior to the transfer, the sender reports to APHIS or CDC the select agent or toxin to be transferred and the name and address of the recipient. (d) On a case-by-case basis, the Administrator may authorize a transfer of a select agent or toxin not otherwise eligible for transfer under this part under conditions prescribed by the Administrator. (e) To obtain authorization for a transfer, APHIS/CDC Form 2 must be submitted. (f) The recipient must submit a completed APHIS/CDC Form 2 within 2 business days of receipt of a select agent or toxin. (g) The recipient must immediately notify APHIS or CDC if the select agent or toxin has not been received within 48 hours after the expected delivery time or if the package containing the select agent or toxin has been damaged to the extent that a release of the select agent or toxin may have occurred. (h) An authorization for a transfer shall be valid only for 30 calendar days after issuance, except that such an authorization becomes immediately null and void if any facts supporting the authorization change (e.g., change in the certificate of registration for the sender or recipient, change in the application for transfer). (i) The sender must comply with all applicable laws governing packaging and shipping. (a) An individual or entity required to register under this part must maintain complete records relating to the activities covered by this part. Such records must include: (1) An accurate, current inventory for each select agent (including viral genetic elements, recombinant nucleic acids, and recombinant organisms) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or lyophilized materials), including: (i) The name and characteristics (e.g., strain designation, GenBank Accession number, etc.); (ii) The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source; (iii) Where stored (e.g., building, room, and freezer); (iv) When moved from storage and by whom and when returned to storage and by whom; (v) The select agent used and purpose of use; (vi) Records created under §121.16 or 42 CFR 73.16 (Transfers); (vii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the select agent, the quantity transferred, the date of transfer, the sender, and the recipient; and (viii) Records created under §121.19 or 42 CFR 73.19 (Notification of theft, loss, or release); (2) An accurate, current inventory for each toxin held, including: (i) The name and characteristics; (ii) The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source; (iii) The initial and current quantity amount (e.g., milligrams, milliliters, grams, etc.); (iv) The toxin used and purpose of use, quantity, date(s) of the use and by whom; (v) Where stored (e.g., building, room, and freezer); (vi) When moved from storage and by whom and when returned to storage and by whom, including quantity amount; (vii) Records created under §121.16 or 42 CFR 73.16 (Transfers); (viii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the toxin, the quantity transferred, the date of transfer, the sender, and the recipient; (ix) Records created under §121.19 or 42 CFR 73.19 (Notification of theft, loss, or release); (x) If destroyed, the quantity of toxin destroyed, the date of such action, and by whom. (3) A current list of all individuals that have been granted access approval by the Administrator or the HHS Secretary; (4) Information about all entries into areas containing select agents or toxins, including the name of the individual, name of the escort (if applicable), and the date and time of entry; (5) Accurate, current records created under §121.9 or 42 CFR 73.9 (Responsible official), §121.11 or 42 CFR 73.11 (Security), §121.12 or 42 CFR 73.12 (Biosafety), §121.14 or 42 CFR 73.14 (Incident response), and §121.15 or 42 CFR 73.15 (Training); and (6) A written explanation of any discrepancies. (b) The individual or entity must implement a system to ensure that all records and databases created under this part are accurate, have controlled access, and that their authenticity may be verified. (c) All records created under this part must be maintained for 3 years and promptly produced upon request. (a) Without prior notification, APHIS must be allowed to inspect any site at which activities regulated under this part are conducted and must be allowed to inspect and copy any records relating to the activities covered by this part. (b) Prior to issuing a certificate of registration to an individual or entity, APHIS may inspect and evaluate the premises and records to ensure compliance with this part. (a) An individual or entity must immediately notify APHIS or CDC upon discovery of the theft or loss of a select agent or toxin. Thefts or losses must be reported even if the select agent or toxin is subsequently recovered or the responsible parties are identified. (1) The theft or loss of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided: (i) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information); (ii) An estimate of the quantity stolen or lost; (iii) An estimate of the time during which the theft or loss occurred; (iv) The location (building, room) from which the theft or loss occurred; and (v) The list of Federal, State, or local law enforcement agencies to which the individual or entity reported, or intends to report, the theft or loss. (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days. (b) An individual or entity must immediately notify APHIS or CDC upon discovery of a release of a select agent or toxin causing occupational exposure or a release of a select agent or toxin outside of the primary barriers of the biocontainment area. (1) The release of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided: (i) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information); (ii) An estimate of the quantity released; (iii) The time and duration of the release; (iv) The environment into which the release occurred (e.g., in building or outside of building, waste system); (v) The location (building, room) from which the release occurred; and (vi) The number of individuals potentially exposed at the entity; (vii) Actions taken to respond to the release; and (viii) Hazards posed by the release. (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days. An individual or entity may appeal a denial, revocation, or suspension of registration under this part. An individual may appeal a denial, limitation, or revocation of access approval under this part.14 14 An entity may not appeal the denial or limitation of an individual's access to select agents or toxins.
Title 9: Animals and Animal Products
PART 121—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
Section Contents
§ 121.1 Definitions.
§ 121.2 Purpose and scope.
§ 121.3 VS select agents and toxins.
§ 121.4 Overlap select agents and toxins.
§ 121.5 Exemptions for VS select agents and toxins.
§ 121.6 Exemptions for overlap select agents and toxins.
§ 121.7 Registration and related security risk assessments.
§ 121.8 Denial, revocation, or suspension of registration.
§ 121.9 Responsible official.
§ 121.10 Restricting access to select agents and toxins; security risk assessments.
§ 121.11 Security.
§ 121.12 Biosafety.
§ 121.13 Restricted experiments.9
§ 121.14 Incident response.10
§ 121.15 Training.
§ 121.16 Transfers.
§ 121.17 Records.
§ 121.18 Inspections.
§ 121.19 Notification of theft, loss, or release.
§ 121.20 Administrative review.
§ 121.1 Definitions.
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§ 121.2 Purpose and scope.
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§ 121.3 VS select agents and toxins.
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§ 121.4 Overlap select agents and toxins.
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§ 121.5 Exemptions for VS select agents and toxins.
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§ 121.6 Exemptions for overlap select agents and toxins.
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§ 121.7 Registration and related security risk assessments.
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§ 121.8 Denial, revocation, or suspension of registration.
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§ 121.9 Responsible official.
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§ 121.10 Restricting access to select agents and toxins; security risk assessments.
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§ 121.11 Security.
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§ 121.12 Biosafety.
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§ 121.13 Restricted experiments.9
top§ 121.14 Incident response.10
top§ 121.15 Training.
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§ 121.16 Transfers.
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§ 121.17 Records.
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§ 121.18 Inspections.
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§ 121.19 Notification of theft, loss, or release.
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§ 121.20 Administrative review.
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