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

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, USDA. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are proposing 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. This Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action would implement findings from the biennial review for the list. The biennial review was initiated within 2 years of the completion of the previous biennial review. In addition, we are proposing to add definitions for several terms; codify policies regarding the role of responsible officials and alternate responsible officials, conclusion of patient care, and annual internal inspections; and revise or clarify provisions related to validated inactivation procedures and viable select agent removal methods, recordkeeping, non-possession of select agents and toxins, electronic Federal Select Agent Programs, registration, Tier 1 enhancements, and exclusion of naturally infected animals. We are also proposing to add requirements for reporting discoveries of select agents and toxins, provisions regarding effluent decontamination system, biosafety provisions for facility verification requirements for registered biosafety level 3 and animal biosafety level 3 laboratories, a new requirement related to restricted experiments, and to correct editorial errors. These proposed changes would economically benefit producers, research and reference laboratories, and State and Federal oversight agencies, while also maintaining adequate program oversight of select agents and toxins. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> We will consider all comments that we receive on or before April 1, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments by either of the following methods: • <E T="03">Federal eRulemaking Portal:</E> Go to <E T="03">www.regulations.gov.</E> Enter APHIS-2019-0018 in the Search field. Select the Documents tab, then select the Comment button in the list of documents. • <E T="03">Postal Mail/Commercial Delivery:</E> Send your comment to Docket No. APHIS-2019-0018, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Commenters should not include any information in their comments or supporting materials that they consider confidential or inappropriate for public disclosure. APHIS will carefully consider all comments submitted in preparation of a final rule. Supporting documents and any comments we receive on this docket may be viewed at <E T="03">www.regulations.gov</E> or in our reading room, which is located in Room 1620 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 7997039 before coming. <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 (referred to below as the Bioterrorism Response 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 Bioterrorism Response Act (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) must establish by regulation 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 Act (7 U.S.C. 8401(a)(1)(B)) requires that the following criteria be considered: • The effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products; • The 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; • The availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; • Whether such inclusion would have a substantial negative impact on the research and development of solutions for the animal and 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 • Any 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 found in the Act. <HD SOURCE="HD2">Advance Notice of Proposed Rulemaking</HD> Pursuant to this same paragraph of the Act, on March 17, 2020, we issued an advance notice of proposed rulemaking (ANPR) in the <E T="04">Federal Register</E> (85 FR 15078-15079, Docket No. APHIS-2019-0018) in which we solicited public comment on the possible delisting of one PPQ select agent, <E T="03">Peronosclerospora philippinensis,</E> formerly known as <E T="03">Peronosclerospora 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 took comment on the ANPR for 60 days, ending May 18, 2020. We received 224 comments by that time. They were from private citizens and stakeholders. We discuss the comments on the ANPR below. Commenters overwhelmingly supported delisting of <E T="03">B. abortus, B. suis,</E> and <E T="03">B. melitensis.</E> We did not receive any comments relative to delisting <E T="03">P. philippinensis</E> or African horse sickness virus. Additionally, we did receive adverse comments regarding our proposed possible removal of Venezuelan equine encephalitis virus (VEEV) and <E T="03">Bacillus anthracis</E> (Pasteur strain). Finally, we received two comments suggesting the delisting of <E T="03">Ralstonia solanacearum</E> Race 3 biovar 2 and several comments suggesting delisting of other agents from the list of select agents and toxins. We acknowledge these requests but before we propose to delist or list an agent, it is reviewed by the Agricultural Interagency Select Agents and Toxins Technical Advisory Committee, or Ag-ISATTAC. In that regard, it is beneficial to clarify how those reviews take place. On a biannual basis, the Ag-ISATTAC, a Federal interagency committee of subject matter experts in domestic and transboundary animal diseases and toxins, reviews existing USDA select agents and toxins and makes recommendations regarding their continued listing, possible delisting, or addition of new agents/toxins, according to several risk categories. Until such time as the Ag-ISATTAC has recommended listing or delisting, we do not propose to do so. In the case o ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 179k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━