Page:United States Statutes at Large Volume 116 Part 1.djvu/679

 PUBLIC LAW 107-188-JUNE 12, 2002 116 STAT. 653 (i) the identification of such agents or toxins is reported to the Secretary, and when required under Federal, State, or local law, to other appropriate authorities; and (ii) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation. (C) PRODUCTS. — (i) IN GENERAL.—Regulations under subsections (b) and (c) shall exempt products that are, bear, or contain overlap agents or toxins and are cleared, approved, licensed, or registered under any of the Acts specified in clause (ii), unless the Secretary by order determines that applying additional regulation under subsection (b) or (c) to a specific product is necessary to protect animal or plant health, or animal or plant products. (ii) RELEVANT LAWS.— For purposes of clause (i), the Acts specified in this clause are the following: (I) The Federal Food, Drug, and Cosmetic Act. (II) Section 351 of the Public Health Service Act. (III) The Act commonly known as the Virus- Serum-Toxin Act (the eighth paragraph under the heading "Bureau of Animal Industry" in the Act of March 4, 1913; 21 U.S.C. 151-159). (IV) The Federal Insecticide, Fungicide, and Rodenticide Act. (iii) INVESTIGATIONAL USE.— (I) IN GENERAL. —The Secretary may exempt an investigational product that is, bears, or contains an overlap agent or toxin from the applicability of provisions of regulations under subsection (b) or (c) when such product is being used in an investigation authorized under any Federal Act and the Secretary determines that applying additional regulation under subsection (b) or (c) to such product is not necessary to protect animal and plant health, and animal and plant products. (II) CERTAIN PROCESSES. —Regulations under subsections (b) and (c) shall set forth the procedures for applying for an exemption under subclause (I). In the case of investigational products authorized under any of the Acts specified in clause (ii), the Secretary shall make a determination regarding a request for an exemption not later than 14 days after the first date on which both of the following conditions have been met by the person requesting the exemption: (aa) The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary. (bb) The person has notified the Secretary that the investigation has been authorized under such an Act. (D) AGRICULTURAL EMERGENCIES.— The Secretary may temporarily exempt a person from the applicability of the

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