Facility Security,Regulations

APHIS TO REVISE ITS LIST OF SELECT AGENTS AND TOXINS
On August 28, 2007, APHIS proposed to amend and republish for the second time its list of select agents and toxins – those agents and toxins that may risk the health of humans, animals, plants, and products of animals and plants,¹ as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.² This Act, also known as “Agricultural Bioterrorism Protection Act of 2002,” requires the Secretary of Agriculture to review and republish the list of select agents and toxins every two years and revise it as necessary.

The U.S. Departments of Health and Human Services (HHS) and Agriculture (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.

The Centers for Disease Control and Prevention (CDC) regulates the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. It has the primary responsibility for implementing this Act for the Department of Health and Human Services (HHS).³ The CDC Select Agent Program oversees these activities and registers all laboratories and other entities in the United States of America that possess, use, or transfer a select agent or toxin.

Both APHIS and the CDC regulate overlap select agents and toxins –those agents and toxins that may be a severe threat to both human and animal health, and animal products. In determining whether to include an agent or toxin in the list, the Act requires APHIS and HHS consider:

“The effect of exposure to the agent or toxin on animal or plant health and on the production and marketability of animal or plant products;
“ The pathogenicity of the agent or the toxin and the methods by which the agent or toxin is transferred to animals or plants;
“ The availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and
“ Any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.”

APHIS propose to remove 10 of the 20 overlap select agents and toxins from the previous list, and add others to create a revised list which is described in Table 1. The CDC would still regulate some of the agents and toxins removed by APHIS.

In its proposal, APHIS redefined the agents and technical terms in order to be consistent with the definitions of the World Organization for Animal Health (OIE).⁴