9 C.F.R. § 121.6 Exemptions for overlap select agents and toxins.
Title 9 - Animals and Animal Products
(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.
Title 9: Animals and Animal Products
PART 121—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
§ 121.6 Exemptions for overlap select agents and toxins.
