United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-10-05 article Part III Rules and Regulations D09002ee1c7fc5995 D09002ee1c7fc5aa5 United States Department of Health and Human Services originator org United States Government Agency or Subagency 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. 77 FR 61084 https://www.govinfo.gov/app/details/FR-2012-10-05/2012-24389 2012-24389 fr05oc12-23 RIN 0920-AA34 4163-18-P Docket No. CDC-2011-0012 https://www.govinfo.gov/app/details/FR-2012-10-05/2012-24389 https://www.govinfo.gov/content/pkg/FR-2012-10-05/html/2012-24389.htm https://www.govinfo.gov/content/pkg/FR-2012-10-05/pdf/2012-24389.pdf Biologics Packaging and Containers Penalties Reporting and Recordkeeping Requirements Transportation 32 p. 61084 61115 77 FR 61084 Title 42 Part 73 42 CFR Part 73 RIN 0920-AA34 Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Federal Register Vol. 77, Issue RULE 2012-24389 III DEPARTMENT OF HEALTH AND HUMAN SERVICES 2012-12-04 Docket No. CDC-2011-0012 4163-18-P 2012-24389 Final rule.

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.

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. Robbin Weyant, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop A-46, Atlanta, Georgia 30333. Telephone: (404) 718-2000. Biologics Packaging and Containers Penalties Reporting and Recordkeeping Requirements Transportation Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review , Agricultural.Select.Agent.Program@aphis.usda.gov lrsat@cdc.gov omb@cdc.gov agents.gov http://edocket.access.gpo.gov/2009/pdf/E9-818.pdf http://oba.od.nih.gov/biosecurity/meetings/200905T/NSABB%20Final%20Report%20on%20PR%205-29-09.pdf http://orise.orau.gov/emi/scapa/files/biosecurity-report.pdf http://www.acq.osd.mil/dsb/reports/ADA499977.pdf http://www.cdc.gov/biosafety/publications/bmbl5/index.htm http://www.selectagent.gov/Select%20Agents%20and%20Toxins%20Exclusions.html http://www.selectagent.gov/SyntheticGenomics.html http://www.selectagents.gov http://www.selectagents.gov/ http://www.who.int/csr/don/2004_04_30/en http://www.who.int/csr/don/2004_05_18a/en/index.html http://www.who.int/csr/sars/country/table2004_04_21/en/ http://www.who.int/mediacentre/releases/2003/np26/en/ http://www8.nationalacademies.org/cp/projectview.aspx?key=49097 www.plospathogens.org www.regulations.gov www.selectagents.gov Vol. 77, no. 194 Office of the Federal Register, National Archives and Records Administration 2012-10-05 continuing daily deposited born digital 353 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-10-05 P0b002ee183626f57 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05oc12 https://www.govinfo.gov/app/details/FR-2012-10-05 https://www.govinfo.gov/content/pkg/FR-2012-10-05/pdf/FR-2012-10-05.pdf https://www.govinfo.gov/content/pkg/FR-2012-10-05/xml/FR-2012-10-05.xml fdlp 60883 61227 DGPO 2012-10-05 2024-06-03 FR-2012-10-05 machine generated eng FR FR-2012-10-05 77 194