Select Agent Regulations

Who's Affected?
If you receive, use, transfer, or store a select agent or toxin, even if it’s one of those old archived samples that no one has opened in years or a vaccine strain of a biological agent that is used in a different manner than stated in its FDA or USDA approval, regulations effective April 18, 2005 mandate that you follow strict rules regarding possession of and access to those agents. Otherwise severe fines and penalties may be imposed on you and/or the university. In addition to criminal penalties, civil money penalties of not more than $250,000 in the case of an individual, and up to $500,000 in the case of any other person who violates the rule (§1003.103).

Here’s a little history of how certain biological and chemical agents have come under increased Federal scrutiny and are now regulated by federal law.

In response to the mandates of “The Antiterrorism and Effective Death Penalty Act of 1996”, additional shipping and handling requirements were placed on facilities that transferred or received a list of agents deemed agents of mass destruction (aka select agents). As of April 15, 1997, commercial suppliers of “select agents” as well as government agencies, universities, research institutions, individuals and private companies seeking to transfer or obtain regulated “select agents” were required to register with the Centers for Disease Control and Prevention (CDC) as a registered facility.

On March 18, 2005 the Department of Health and Human Services and the Department of Agriculture published final rules governing the way select agents and toxins are to be managed within the United States. The final rule was effective April 18, 2005, with a phase-in schedule for certain sections that includes possession. Updates occur regularly, usually on an annual basis.

To view the regulations click on: 42 CFR Part 73, Possession, Use, and Transfer of Select Agents and Toxins

7 CFR Part 331 and 9 CFR Part 121, Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins; Final Rule

All registrations must be coordinated through the UAB Department of Occupational Health and Safety, who is responsible for the facility (entity) registration. Anyone planning to do research involving “select agents” must register with the UAB Department of Occupational Health and Safety before obtaining a select agent. No “select agent” may be received at or transferred from UAB without prior registration. For Select Agent Registration contact Elaine Broussard.

Investigators expecting to use a “select agent” are advised to contact OH&S (4-2487) for an application packet and obtain a UAB “Permit for Use” to avoid delays in individual receipt, use, or transfer of material. Call OH&S (4-2487) if you have questions.

Changes in the rules may continue to occur, usually annually, but more often as situations arise. Those changes will be posted on the OH&S web site. To have updates forwarded directly to you, subscribe to the OH&S Safety Shorts distribution list. To subscribe to the list click here.

*If you have questions about downloading files Click Here.

Select Agents Handling and Laboratory Security

Click here to view the current list of select agents

42 CFR Part 73 - Possessing, Use and Transfer of Select Agents & Toxins

More Select Agent Info from CDC:

Laboratory Security and Emergency Response Guidance for Laboratories Working with Select Agents

National Select Agent Registry

Send your request for Select Agent Registration to Elaine Broussard