National Select Agent Registry phone numbers for APHIS (301-851-3300) and CDC (404-718-2000).
Last Updated: Friday, September 24, 2010

Regulations

Select Agents Regulations

Comments on the 2010 Biennial Review of the Lists of Select Agents and Toxins

Advance notices of proposed rulemaking and request for comments were published in the Federal Register to solicit public comment on the current list of select agents and toxins, including whether any biological agent or toxin should be added to or removed from the list. We also sought comments as to whether we should "tier" or "stratify" the select agent list based on the relative bioterrorism risk of each agent or toxin.

Public comments received by APHIS on the Advance Notice of Proposed Rulemaking
(Note that, to view the list of public comments and to view the comments themselves, you must first check the box "Public Submissions" below the search field in the middle of the page.)

Public comments received by CDC on the Advance Notice of Proposed Rulemaking

The Animal and Plant Health Inspection Service (APHIS) and the Centers for Disease Control and Prevention (CDC) published final rules in the Federal Register on October 16, 2008 that complete the biennial review and republication of the lists of Select Agents and toxins. The Final Rules published on October 16 became effective on November 17, 2008.

The APHIS Select Agents Regulations (7 CFR Part 331 and 9 CFR Part 121) regulates biological agents and toxins (Select Agents) that pose a potential threat to animal and plant health or to the safety of animal or plant products.

Download APHIS Select Agents Regulations (7 CFR Part 331) (published October 16, 2008) Adobe PDF (PDF 35 KB)

Download APHIS Select Agents Regulations (9 CFR Part 121) (published October 16, 2008) Adobe PDF (PDF 97 KB)

The CDC Select Agents Regulations (42 CFR Part 73) govern the possession, use and transfer of Select Agents that have the potential to pose a severe threat to public health and safety.

Download CDC Select Agents Regulations (42 CFR Part 73) (published October 16, 2008) Adobe PDF (PDF 82 KB)

Click here for more information regarding Select Agents and toxins.

History of Select Agents Regulations

Final Rules: APHIS and CDC implemented the provisions of Public Law 107-188, the "Public Health Security and Bioterrorism Preparedness Response Act of 2002" (The Act) through a series of regulations. These regulations culminated with the publication of the final Select Agents Regulations (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121) in the Federal Register on March 18, 2005. The Final Rules were published in the Federal Register on March 18, 2005 and became effective on April 18, 2005.

Download 7 CFR Part 331 and 9 CFR Part 121 Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins; Final Rule (published March 18, 2005) Adobe PDF(one document) (PDF 333 KB)

Download 42 CFR Parts 72 and 73 Office of Inspector General 42 CFR Part 1003 Possession, Use, and Transfer of Select Agents and Toxins; Final Rule (published March 18, 2005) Adobe PDF (PDF 254 KB)


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Animal and Plant Health Inspection Service Agricultural Select Agent Program 4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 Riverdale, MD 20737 FAX: 301-734-3652 E-mail: ASAP@aphis.usda.gov and Centers for Disease Control and Prevention Division of Select Agents and Toxins 1600 Clifton Road NE, Mailstop A-46 Atlanta, GA 30333 FAX: 404-718-2096 E-mail: lrsat@cdc.gov