III. Applicable Regulations

Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001:

This law criminalizes the possession of select agents for which there is no legitimate purpose, banned the possession of select agents by a set of “restricted persons”, and required the Secretary of Health and Human Services (HSS) to establish additional standards and procedures governing the possession, use, and transfer of select agents. 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. The Patriot Act is a Federal anti-Terrorism Law that makes it criminal to “knowingly possess any biological agent, toxin, or delivery system of a type or in a quantity that … is not reasonably justified by a … bona fide research or other peaceful purpose.” Intent to use the material as a weapon is not required.

Public Health Security and Bioterrorism Preparedness and Response Act of 2002:

This law established legal requirements regarding the possession, use and transfer of select agents and toxins. The Department of Health and Human Services (DHHS)/Center for Disease Control and Prevention (CDC [2]) and United States Department of Agriculture (USDA [3]) have set forth rules regarding the possession, use and transfer of select agents and toxins. These rules, defined as the Select Agent Program , are outlined in 42 CFR 73 [4] (Code of Federal Regulations) for the CDC and 7 CFR 331 and 9 CFR 121 [4] for USDA/APHIS. The initial program took effect in 2002; the interim Final Rule has since been replaced with the Final Rule on March 18, 2005; the regulations undergo biennial review.