10.0 Select Agents and Toxins

As required by the Public Health Security and Bioterrorism Act of 2002, the DHHS (Department of Health and Human Services) and USDA (United States Department of Agriculture) have set forth rules regarding the possession, use and transfer of select agents and toxins.  The biological agents and toxins subject to these rules have the potential to pose a severe threat to public health and safety, to animal health or to animal products.  These rules, defined as the Select Agent Program, are outlined in the CFR (Code of Federal Regulations), Title 42, part 73, Possession, Use and Transfer of Select Agents and Toxins.  The initial program took effect in 2002; the interim Final Rule has since been replaced with the Final Rule on March 18, 2005.  

In this section an overview of the Select Agent Program will be presented.  The Select Agent Program requires that any facilities, including government agencies, universities, research institutions and commercial entities, that possess, use or transfer select agents or toxins register with the CDC (Center for Disease Control and Prevention) or USDA (United States Department of Agriculture), depending on the agents involved.  For a more detailed description, please visit the CDC’s or USDA’s Select Agent Homepage where a full account of the Final Rule is published.