Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List

<RULE> DEPARTMENT OF AGRICULTURE <SUBAGY>Animal and Plant Health Inspection Service</SUBAGY> <CFR>7 CFR Part 331</CFR> <CFR>9 CFR Part 121</CFR> <DEPDOC>[Docket No. APHIS-2019-0018]</DEPDOC> <RIN>RIN 0579-AE52</RIN> <SUBJECT>Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Animal and Plant Health Inspection Service, Department of Agriculture (USDA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> In accordance with Title II, Subtitle B of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (which is cited as the “Agricultural Bioterrorism Protection Act of 2002” and referred to as the Act), we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins (the list) and the revision of the list as necessary. This action implements the findings from the biennial review of the list. The biennial review was initiated within 2 years of the completion of the previous biennial review. This final rule will focus solely on removing from the select agent list the following pathogens: <E T="03">Peronosclerospora philippinensis (Peronosclerospora sacchari)</E> (Plant Protection and Quarantine select agent), African horse sickness virus (Veterinary Services select agent), and <E T="03">Brucella abortus, Brucella suis,</E> and <E T="03">Brucella melitensis</E> (overlap select agents). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Effective January 16, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Dr. Jacek Taniewski, DVM, Director, Division of Agricultural Select Agents and Toxins, ERCS, APHIS, 4700 River Road, Riverdale, MD 20737; (301) 851-3352; <E T="03">jacek.taniewski@usda.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Background</HD> The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as amended (referred to below as the Bioterrorism Response Act or the Act) provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to human, animal, and plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the responsibility for implementing the provisions of the Bioterrorism Response Act within the U.S. Department of Agriculture (USDA). Veterinary Services (VS) select agents and toxins, listed in 9 CFR 121.3, are those that have been determined to have the potential to pose a severe threat to animal health or animal products. Plant Protection and Quarantine (PPQ) select agents and toxins, listed in 7 CFR 331.3, are those that have been determined to have the potential to pose a severe threat to plant health or plant products. Overlap select agents and toxins, listed in 9 CFR 121.4, are those that have been determined to pose a severe threat to public health and safety, to animal health, or to animal products. Overlap select agents are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), which has the primary responsibility for implementing the provisions of the Act for the U.S. Department of Health and Human Services (HHS). Together, APHIS and CDC comprise the Federal Select Agent Program (FSAP). Title II, Subtitle B of The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as amended, (which is cited as the “Agricultural Bioterrorism Protection Act of 2002,” and referred to below as the Act), section 212(a)(1)(A) (7 U.S.C. 8401(a)(1)(A)), provides, in part, that the Secretary of Agriculture (the Secretary) “shall by regulation establish and maintain a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products.” In determining whether to include an agent or toxin in the list, the Secretary shall consider the following criteria stated in the Act (7 U.S.C. 8401(a)(1)(B)): • “[T]he effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products;” • “[T]he pathogenicity of the agent or the toxicity of the toxin and the methods by which the agent or toxin is transferred to animals or plants;” • “[T]he availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin;” • “[W]hether such inclusion would have a substantial negative impact on the research and development of solutions for the animal or plant disease caused by the agent or toxin; and whether the negative impact [on research and development] would substantially outweigh the risk posed by the agent or toxin to animal or plant health if it is not included on the list” (added by the 2018 Farm Bill); and • “[A]ny other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.” Paragraph (a)(2) of section 212 of the Act (7 U.S.C. 8401(a)(2)) requires the Secretary to review and republish the list of select agents and toxins every 2 years and to otherwise revise the list as necessary. To fulfill this statutory mandate, APHIS convenes separate interagency working groups in order to review the lists of PPQ and VS select agents and toxins, as well as any overlap select agents and toxins, and develop recommendations regarding possible changes to the list using the five criteria for listing, stated above, found in the Act. APHIS and CDC coordinate on the biennial review for overlap select agents and toxins that have been determined to pose a severe threat to human and animal health or animal products. On March 17, 2020, we published in the <E T="04">Federal Register</E> (85 FR 15078-01, Docket No. APHIS-2019-0018) an advance notice of proposed rulemaking (ANPR)  <SU>1</SU> <FTREF/> and request for comments in which we solicited public comment on the possible delisting of one PPQ select agent, <E T="03">Peronosclerospora philippinensis (P. sacchari),</E> one VS select agent, African horse sickness virus, and five overlap select agents, <E T="03">Bacillus anthracis</E> (Pasteur strain), <E T="03">Brucella abortus, B. suis,</E> and <E T="03">B. melitensis,</E> and Venezuelan equine encephalitis virus. We discussed the comments received on the ANPR in the proposed rule that followed. On January 30, 2024, we published in the <E T="04">Federal Register</E> (89 FR 5795-5819, Docket No. APHIS-2019-0018) a proposal  <SU>2</SU> <FTREF/> to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. We proposed to delist P. philippinensis ( <E T="03">sacchari),</E> African horse sickness virus, <E T="03">B. abortus, B. suis,</E> and <E T="03">B. melitensis.</E> <FTNT> <SU>1</SU>  To view the ANPR and the comments we received, go to <E T="03">www.regulations.gov.</E> Enter APHIS-2019-0018 in the Search field. </FTNT> <FTNT> <SU>2</SU>  To view the proposed rule and the comments we received, go to <E T="03">www.regulations.gov.</E> Enter APHIS-2019-0018 in the Search field. </FTNT> In the proposed rule, we also proposed additional changes to the regulations beyond those discussed in the ANPR. Certain of these changes were, in our assessment, codifications of existing operational policy. These included provisions related to: Discovery of a select agent or toxin, disposal of select agent waste after conclusion of patient care, the exclusion of animals naturally infected with select agents from the requirements of the regulations, allowing individuals other than the responsible official ( <E T="03">e.g.,</E> principal investigators) to revise inactivation procedure documentation, removal procedures, and the content of annual internal inspections. Other changes were intended as clarifications of existing provisions of the regulations. These included proposed definitions of loss, release, and theft, clarifying reporting requirements for “discovered” select agents or toxins, a clarification regarding what constitutes an acceptable “validated inactivation procedure,” clarifications related to the existing reporting requirements, clarifying that certificates must accompany transfers of a select agent or toxin, including intra-entity transfers, clarifying that the documentation in the IT system for the FSAP program serves as official records required by the regulations, clarifying the documentation that may be needed for the issuance of a certificate of registration, clarifying that a responsible official cannot be approved as the responsible official at more than one registered entity and cannot be the sole alternate responsible official at another registered entity, clarifying requirements related to restricted experiments, clarifying the notification requirements for changes to the application for registration, and clarifying the scope of pre-access suitability assessments. Finally, certain proposed provisions would have been new, including provisions regarding effluent decontamination system, biosafety provisions for facility verification requirements for registered biosafety level 3 and animal biosafety level 3 laboratories, and a new requirement related to restricted experiments. We solicited comments concerning our proposal for 60 days, ending April 1, 2024. We received 69 comments by that date. The comments were from private citizens, research institutions, organizations representing r ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 64k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━