Select Agent Program

Ricketts-Lab-700px.jpg                                    Howard T. Ricketts in a lab in Mexico, n.d.                        

 

Our Biological Safety Team oversees research related to biological select agents and toxins to ensure compliance with federal regulations. Our select agent program is currently managed at the state-of-the-art biocontainment facility, the Howard Taylor Ricketts Laboratory, situated on Argonne National Labs campus.

The Select Agent Regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) implement the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. The Select Agent Regulations can be found here.

What is a select agent and toxin?

Select agents and toxins are those biological agents and toxins that have the potential to pose a severe threat to public health and safety, to animal health, or to animal products.

What if I don’t know if I’m working with a select agent or toxin?

If you are unsure whether you are working with biological materials that are considered select agents or toxins, you can view a complete list here.

For more information on the University of Chicago Select Agent Program or to inquire about initiating research involving Select Agents, please contact our Biological Safety Team.

A Brief History

On October 26, 2001, President Bush signed the “Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism” (USA PATRIOT) Act. The law places restrictions on persons who possess select agents and provides criminal penalties for possession of any biological agent that cannot be justified for specified peaceful purposes. More information on the USA PATRIOT Act can be found at Department of Justice website.

On June 12, 2002, President Bush signed the “Public Health Security and Bioterrorism Preparedness and Response Act of 2002” (the Act). The Act is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.

Section 201(a) of the Act amends the Public Health Service Act (42 U.S.C. 262a) by requiring all persons possessing, using or transferring biological agents or toxins designated by the Secretary of the U.S. Department of Health and Human Services (HHS Secretary) as having the potential to pose a severe threat to public health and safety (i.e., HHS select agents and toxins) to register with the HHS Secretary and meet biosafety and security procedures established by the HHS Secretary.

Section 212 of the Act requires all persons possessing, using or transferring biological agents or toxins designated by the Secretary of the U.S. Department of Agriculture as having the potential to pose a severe threat to animal or plant health and to animal or plant products (i.e. USDA select agents and toxins) to register with the USDA Secretary and meet biosafety and security procedures established by the USDA Secretary.

The HHS Select Agent regulations can be found in part 73 of Title 42 of the Code of Federal Regulations (42 CFR 73).

The USDA Select Agent regulations covering threats to animals and animal products can be found at part 121 of Title 9 Code of Federal Regulations (9 CFR 121). The USDA Select Agent regulations covering threats to plants and plant products can be found at part 331 of Title 7 Code of Federal Regulations (7 CFR 331).

The Centers for Disease Control and Prevention (CDC) has been designated as the HHS agency responsible for promulgating, implementing, and providing guidance on 42 CFR 73.

The Animal and Plant Health Inspection Service (APHIS) has been designated as the USDA agency responsible for promulgating, implementing, and providing guidance on 9 CFR 121 and 7 CFR 331.

The Act can be found at the Federal Register website.