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Department of Agriculture Vol. 76 Monday, No. 191 October 3, 2011 Part V Department of Agriculture Animal and Plant Health Inspection Service 7 CFR Part 331 9 CFR Part 121 Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations; Proposed Rule VerDate Mar<15>2010 18:12 Sep 30, 2011 Jkt 226001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\03OCP3.SGM 03OCP3 srobinson on DSK4SPTVN1PROD with PROPOSALS3 61228 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules DEPARTMENT OF AGRICULTURE and Development, PPD, APHIS, Station determines has the potential to pose a 3A–03.8, 4700 River Road Unit 118, severe threat to animal or plant health, Animal and Plant Health Inspection Riverdale, MD 20737–1238. or to animal or plant products. Service Supporting documents and any Paragraph (a)(2) of section 212 requires comments we receive on this docket the Secretary to review and republish 7 CFR Part 331 may be viewed at http:// the list every 2 years and to revise the www.regulations.gov/ list as necessary. In this document, we 9 CFR Part 121 #!docketDetail;D=APHIS-2009-0070 or are proposing to amend and republish [Docket No. APHIS–2009–0070] in our reading room, which is located in the list of select agents and toxins based room 1141 of the USDA South Building, on the findings of our third biennial RIN 0579–AD09 14th Street and Independence Avenue, review of the list. SW., Washington, DC. Normal reading In determining whether to include an Agricultural Bioterrorism Protection room hours are 8 a.m. to 4:30 p.m., agent or toxin on the list, the Act Act of 2002; Biennial Review and Monday through Friday, except requires that the following criteria be Republication of the Select Agent and holidays. To be sure someone is there to considered: Toxin List; Amendments to the Select help you, please call (202) 690–2817 • The effect of exposure to the agent Agent and Toxin Regulations before coming. or the toxin on animal and plant health, AGENCY: Animal and Plant Health FOR FURTHER INFORMATION CONTACT: Mr. and on the production and marketability Inspection Service, USDA. Charles L. Divan, Branch Chief, APHIS of animal or plant products; • The pathogenicity of the agent or ACTION: Proposed rule. Agriculture Select Agent Program, APHIS, 4700 River Road Unit 2, the toxin and the methods by which the SUMMARY: In accordance with the Riverdale, MD 20737–1231; (301) 734– agent or toxin is transferred to animals Agricultural Bioterrorism Protection Act 5960. or plants; • The availability and effectiveness of of 2002, we are proposing to amend and SUPPLEMENTARY INFORMATION: republish the list of select agents and pharmacotherapies and prophylaxis to toxins that have the potential to pose a Background treat and prevent any illness caused by severe threat to animal or plant health, The Public Health Security and the agent or toxin; and • Any other criteria that the Secretary or to animal or plant products. The Act Bioterrorism Preparedness and considers appropriate to protect animal requires the biennial review and Response Act of 2002 (referred to below or plant health, or animal or plant republication of the list of select agents as the Bioterrorism Response Act) products. and toxins and the revision of the list as provides for the regulation of certain We use the term ‘‘select agents and necessary. This action would implement biological agents that have the potential toxins’’ throughout the preamble of this the findings of the third biennial review to pose a severe threat to both human proposed rule. Unless otherwise of the list. In addition, we are proposing and animal health, to animal health, to specified, the term ‘‘select agents and to reorganize the list of select agents and plant health, or to animal and plant toxins’’ will refer to all agents or toxins toxins based on the relative potential of products. The Animal and Plant Health listed by APHIS. When it is necessary to each select agent or toxin to be misused Inspection Service (APHIS) has the specify the type of select agent or toxin, to adversely affect human, plant, or primary responsibility for implementing we will use the following terms: ‘‘PPQ animal health. Such tiering of the list the provisions of the Act within the select agents and toxins’’ (for the plant would allow for the optimization of Department of Agriculture (USDA). agents and toxins listed in 7 CFR 331.3), security measures for those select agents Veterinary Services (VS) select agents ‘‘VS select agents and toxins’’ (for the or toxins that present the greatest risk of and toxins are those that have been animal agents and toxins listed in 9 CFR deliberate misuse with the most determined to have the potential to pose 121.3), or ‘‘overlap select agents and significant potential for mass casualties a severe threat to animal health or toxins’’ (for the agents and toxins listed or devastating effects to the economy, animal products. Plant Protection and critical infrastructure, or public in both 9 CFR 121.4 and 42 CFR 73.4). Quarantine (PPQ) select agents and On July 29, 2010, we published in the confidence. We are also proposing a toxins are those that have the potential number of amendments to the Federal Register (75 FR 44724–44725, to pose a severe threat to plant health Docket No. APHIS–2009–0070) an regulations, including the addition of or plant products. Overlap select agents definitions and clarification of language advance notice of proposed rulemaking and toxins are those that have been and request for comments (ANPR) 1 in concerning security, training, biosafety, determined to pose a severe threat to biocontainment, and incident response. order to announce our intention to both human and animal health or review and reorganize the select agent These changes would increase the animal products. Overlap select agents usability of the select agent regulations list. We solicited comments regarding are subject to regulation by both APHIS potential additions and deletions from as well as provide for enhanced program and the Centers for Disease Control and oversight. the list of select agents and toxins as Prevention (CDC), which has the well as comments on reorganization of DATES: We will consider all comments primary responsibility for implementing the list based on the relative potential of that we receive on or before December the provisions of the Act for the each select agent or toxin to be misused 2, 2011. Department of Health and Human to adversely affect human, plant, or ADDRESSES: You may submit comments Services (HHS). animal health. We requested Subtitle B (which is cited as the by either of the following methods: recommendations as to what criteria • ‘‘Agricultural Bioterrorism Protection Federal eRulemaking Portal: Go to should be utilized to designate high risk Act of 2002’’ and referred to below as http://www.regulations.gov/ select agents and toxins and the Act), section 212(a), provides, in #!documentDetail;D=APHIS-2009-0070- incorporated those recommendations 0001. part, that the Secretary of Agriculture • Postal Mail/Commercial Delivery: (the Secretary) must establish by 1 To view the ANPR and the comments we Send your comment to Docket No. regulation a list of each biological agent received, go to http://www.regulations.gov/ APHIS–2009–0070, Regulatory Analysis and each toxin that the Secretary #!docketDetail;D=APHIS-2009-0070. VerDate Mar<15>2010 18:12 Sep 30, 2011 Jkt 226001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\03OCP3.SGM 03OCP3 srobinson on DSK4SPTVN1PROD with PROPOSALS3 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Proposed Rules 61229 into the interagency working group (exotic), Bovine spongiform to which Federal, State, and/or local discussions on the matter. We solicited encephalopathy agent; Camel pox virus; officials need to take special action in comments for 30 days ending August Ehrlichia ruminantium (Heartwater); planning for a major animal health 30, 2010. We received 30 comments by Japanese encephalitis virus; Malignant disaster as a result of any of these that date. They were from scientists, catarrhal fever virus (Alcelaphine organisms is decreased in light of these scientific organizations, private herpesvirus type 1); Menangle virus; factors. Therefore, in considering these individuals, and industry groups. and Vesicular stomatitis virus (exotic): reasons as well as recommendations Suggestions in these comments were Indiana subtypes VSV–IN2, VSV–IN3. provided in previous reports such as used in order to inform our discussions The interagency working group ‘‘The Report of the Working Group on on the content of the select agent list considered each of the VS select agents Strengthening the Biosecurity of the and our determination regarding and toxins with respect to the four United States’’ 2 and the ‘‘Federal reorganization of the list. criteria for listing found in the Act and Experts Security Advisory Panel: based on the group’s analysis, APHIS Recommendations Concerning the PPQ Select Agents and Toxins has determined that the nine VS select Select Agent Program’’ 3 as well as APHIS’s PPQ program convened an agents and toxins listed above should be comments received on the ANPR, interagency working group to review the removed from the list. These agents APHIS has determined those pathogens list of PPQ select agents and toxins and were judged not to pose a significant listed here are not likely to be used as develop recommendations regarding threat
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