Agricultural Select Agent Program
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188; June 12, 2002) requires that the United States improve its ability to prevent, prepare for, and respond to acts of bioterrorism and other public health emergencies that could threaten either public health and safety or American Agriculture. It necessitates that individuals possessing, using, or transferring agents or toxins deemed a severe threat to public, animal or plant health, or to animal or plant products notify either the Secretary of the Department of Health and Human Services (HHS) or the Secretary of the Department of Agriculture (USDA). In accordance with the Act, implementing regulations detailing the requirements for possession, use, and transfer for select agents and toxins were published by HHS (42 CFR part 73) and by USDA (9 CFR part 121 and 7 CFR part 331) .
Registration of an entity requires that an “Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins” (APHIS/CDC Form 1) should be completed and submitted to either HHS Centers for Disease Control (CDC) or to USDA Animal Plant Health Inspection Service (APHIS). Registration also requires that the U.S. Department of Justice (DOJ) complete a security risk assessment (SRA) for the facility, its owners, and the designated responsible official. Before registration is granted, the facility must also meet biosafety requirements that are commensurate with the risk that the select agent or toxin poses and must establish security measures that provide graded protection in accordance with the threat that the agent or toxin poses.
An entity that needs to register in order to possess, use, or transfer a select agent or toxin must submit its registration information to either APHIS or CDC, but is not required to submit the application to both APHIS and CDC.
In determining whether a select agent or toxin should be included on the USDA list, the following were considered:
• The effect of an agent or toxin on animal or plant health or products;
• The virulence of an agent or degree of toxicity of the toxin and the methods by which the agents or toxins are transferred to animals or plants;
• The availability and effectiveness of medicines and vaccines to treat and prevent any illness caused by an agent or toxin; and
• Other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.
Information Resources |
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Preconference ABSA Course About Select Agents
March 8, 2007 Security Plan Information
Oct 20, 2006 Revised Version of the FBI FD-961 Form
Jun 6, 2006 Please note that the Select Agent Forms formerly available on this website have been revised and are now available only at http://www.selectagents.gov/.
Mar 18, 2005 USDA Finalizes Regulations on Agricultural Select Agents and Toxins
The U.S. Departments of Agriculture and Health and Human Services (HHS) (USDA) published final rules for the possession, use, and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) in the Federal Register on March 18, 2005. All provisions of these final rules supersede those contained in the interim final rules and became effective on April 18, 2005.
Mar 10, 2005 Plum Pox potyvirus and Phakopsora pachyrhizi, commonly known as Asian soybean rust have been removed from the USDA list of Select agents and toxins; however, the interstate movement or importation of cultures or infected plant material still requires a PPQ plant pest permit (PPQ Form 526) in accordance with 7 CFR part 330.200. For further information about PPQ permits contact the permit unit at 1-877-770-5990 or visit the PPQ permit website.
Contacts |
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APHIS Select Agent Program:
4700 River Road , Unit 2
Riverdale , MD 20737
Email: Agricultural.Select.Agent.Program@aphis.usda.gov
Phone: 301-734-5960
Fax: 301-734-3652
CDC Select Agent Program:
Email: lrsat@cdc.gov
Phone 404-718-2000
Fax: 404-718-2097