{"abstract":"In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is republishing that list. As a result of our review, we have added Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We have also removed from the list of HHS and overlap select agents and toxins, or excluded from compliance with part 73, the agents and toxins described in the Executive Summary. Further, in accordance with Executive Order 13546, \"Optimizing the Security of Biological Select Agents and Toxins in the United States,\" HHS/CDC has designated those select agents and toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence as \"Tier 1\" agents; established new security requirements for entities possessing Tier 1 agents, including the requirement to conduct pre- access assessments and on-going monitoring of personnel with access to Tier 1 agents and toxins; and made revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture (USDA) has made parallel regulatory changes.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2012/10/05/2012-24389.html","cfr_references":[{"chapter":null,"citation_url":null,"part":73,"title":42}],"citation":"77 FR 61084","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective Dates: The amendments to Sec. Sec. 73.1, 73.3 through 73.6, 73.9, 73.10, 73.13, 73.16, 73.17, and 73.20, of Title 42, Code of Federal Regulations are effective December 4, 2012. The remaining provisions to this final rule are effective April 3, 2013.","disposition_notes":null,"docket_ids":["Docket No. CDC-2011-0012"],"dockets":[],"document_number":"2012-24389","effective_on":"2012-12-04","end_page":61115,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/10/05/2012-24389.xml","html_url":"https://www.federalregister.gov/documents/2012/10/05/2012-24389/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-24389?publication_date=2012-10-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-10-05/2012-24389/mods.xml","not_received_for_publication":null,"page_length":32,"page_views":{"count":4286,"last_updated":"2026-06-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-10-05/pdf/2012-24389.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-24389.pdf?1349191033","publication_date":"2012-10-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/10/05/2012-24389.txt","regulation_id_number_info":{"0920-AA34":{"issue":"201110","html_url":"https://www.federalregister.gov/regulations/0920-AA34/public-health-security-and-bioterrorism-preparedness-and-response-act-of-2002-biennial-review-and-re","title":"Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201110&RIN=0920-AA34&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0920-AA34"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Extension to submit public comments","document_id":"CDC-2011-0012-0115"},{"title":"FESAP Report","document_id":"CDC-2011-0012-0003"},{"title":"Regulatory Impact Analysis","document_id":"CDC-2011-0012-0002"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0920-AA34/public-health-security-and-bioterrorism-preparedness-and-response-act-of-2002-biennial-review-and-re","title":"Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CDC-2011-0012","supporting_documents_count":3,"docket_id":"CDC-2011-0012","regulation_id_number":"0920-AA34","title":"Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review","checked_regulationsdotgov_at":"2012-10-25T08:03:38Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":61084,"subtype":null,"title":"Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review","toc_doc":"Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review","toc_subject":null,"topics":["Biologics","Packaging and containers","Penalties","Reporting and recordkeeping requirements","Transportation"],"type":"Rule","volume":77}