Select Agents & Toxins
- Current List of Select Agents and Toxins
- Permissible Toxin Amounts (Duke Policy Applies)
- Permissible Toxin Ordering
- Duke Exempt Quantity Select Toxin Policy
Biological agents and toxins that the Federal Select Agent Program (FSAP) has determined to pose a severe threat to both human and animal health, to plant health, or to animal and plant products are known as Select Agents/Toxins. The Duke Select Agent Program (SAP) has oversight over all research, transfer, receipt and storage of select agents and toxins at Duke University as outlined in the Federal Select Agents and Toxins Regulations, 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121. The Duke SAP helps achieve compliance by providing initial and annual training, facilitating FBI/CJIS security clearance for registrants, maintaining program records for inspection by the CDC/USDA, leading inspection visits, coordinating the transfer of select agents and toxins, ensuring properly functioning facilities and conducting drills and exercises to test the various site-specific response and safety plans.
The regulations requires that a Responsible Official (RO) be designated at each institution. The RO is the primary point of contact for all select agents and toxins related matters. The primary responsibility of the RO is to oversee the registration of laboratories with the CDC and/or the APHIS, and assure that all requirements of compliance are met. The Director of the Biological Safety Division of the Occupational and Environmental Safety Office (OESO) serves as the Duke RO. Additional individuals, known as Alternate Responsible Officials (ARO), may be designated by the RO to act as the RO during their absence.
Working with Select Agents and Toxins
Anyone planning to work with select agents/toxins must enroll in the Duke SAP and receive approval prior to the possession, use and transfer of select agents/toxins. If unescorted access to registered select agents and toxins areas is needed, contact the RO to enroll in the Duke SAP.
Prior to being granted access to Tier 1 select agents and toxins, all registrants must be successfully enrolled in the Personnel Suitability Program in addition to being enrolled in the SAP. Registrants must also be able to successfully complete the annual on-going suitability assessments. Contact the RO for more details.
The Principal Investigator (PI) is held responsible for assuring that they register all possession, transfer, and receipt of select agents and toxins through the Biological Safety Office. They are also responsible for assuring that their laboratory fully complies with all the prescribed safety policies and procedures. Consequently, the PI must work closely with the RO to assure compliance with the federal select agent regulations and Duke policies and procedures.