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. |