Many biological agents and toxins have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. An attenuated strain of a select agent or an inactive form of a select toxin may be excluded from the requirements of the Select Agent Regulations.
Various agencies have contributed to the list of select agents, and as such groups of agents and toxins have been made primarily related to whether it causes harm in humans, animals, both, and/or plants.
- HHS Select Agents And Toxins
- Overlap Select Agents And Toxins
- USDA Veterinary Services (VS) Select Agents
- USDA Plant Protection And Quarantine (PPQ) Select Agents And Toxins
You may report biosafety/security concerns associated with Select Agents/Toxins via an anonymous hotline. When reporting issues indicate it’s a "Select Agent Program" issue.
USDA Office of Inspector General
Complete List of Select Agents and Toxins (SelectAgents.gov)
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (FDA.gov)
Public Health Security and Bioterrorism Preparedness
Act of 2002 - Public Law 107-877 - July 12, 2002
THIS NEW REGULATION COULD AFFECT YOUR RESEARCH
Management of the Select Agents Program at the University of South Alabama is accomplished through the Biosafety Office. The contact is Ms. Dusty Layton at 460-6041. This new regulation addresses the security of select infectious agents, toxins, and genetic elements (refer to attached list). The new law focuses on possession of materials that are not uncommon in biomedical research labs, and calls for the Department of Health and Human Services to be more aggressive in tracking individuals who have them. This new law takes the Patriot Act to the next level. The intensified concern over bioterrorism in the aftermath of September 11 have caused Congress to increase its scrutiny of potential sources of biological agents that could pose a risk to the public's health and safety, including the nation's university laboratories. On May 22, the US House and Senate approved House Rule 3448 and President Bush signed it into law on June 12, 2002 (Public Law 107-188).
BACKGROUND - Why is there a Select Agents Law? "The Antiterrorism and Effective Death Penalty Act of 1996," which became effective on April 15, 1997, and the "Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) of 2001'' establish provisions that regulate the possession, usage, or transfer of hazardous agents, and required the Department of Health and Human Services to issue rules to implement these provisions. The Center for Disease Control proposed new regulations to meet the requirements of this statute. Specifically, the law was designed to (1) establish a system of safeguards to be followed when specific agents are transported; (2) collect and provide information concerning the location where certain potentially-hazardous agents are transferred (3) track the acquisition and transfer of these specific agents; and (4) establish a process for alerting appropriate authorities if an unauthorized attempt is made to acquire these agents. The directive also places additional shipping and handling requirements on facilities that transfer or receive select infectious agents.
The new law dictates that you must register with the CDC if you merely possess these infectious agents, toxins, and genetic elements. In the July 2nd Federal Register, the CDC published a proposed data collection system for notification of Select Agents possession. Section 202(a) of the Act requires that all persons in possession of a Select Agent notify the Secretary of Health and Human Services by September 10, 2002. Excerpt from the FR notice "In order to complete the application, the RFO will need to inventory its facility and consult with others (e.g., principal investigators) as necessary to obtain the information required for this application. The Responsible Facility Official (RFO) must review and sign the application and will be the point of contact if CDC has questions concerning the application or other matters related to the Public Law.