Select Agent Program
The Federal Select Agent Program regulates all work with select agents and toxins, including possession, use and transfer. Select agents and toxins can pose a severe threat to public, animal or plant health, or to animal or plant products. The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention and the Animal and Plant Health Inspection Services. At the LSU, there is currently NO established Select Agent Program, therefore work with Select Agents is at present, prohibited.
Working with select agents and toxins requires higher scrutiny and increased responsibility for biosecurity. Researchers who work with Select Agents must comply with all components of the Federal Select Agent Program, including federal security clearance, ongoing training, inventory management and authorization. The Federal Select Agent Program website has more information about personnel restrictions, agent registration, laboratory security requirements, and strict criteria to receive or transfer select agents and toxins.
Failure to comply with the Select Agent regulations is considered a violation of federal law and may be associated with criminal and civil liability.
For any transfer of select toxins in any amount to any intra- or extramural entity or individual requires documentation of due diligence.
Regulated select toxins include:
- Botulinum neurotoxins
- Short, paralytic alpha conotoxins
- Diacetoxyscirpenol (DAS)
- Staphylococcal enterotoxins (subtypes A, B, C, D, and E)
- T2 toxin
All work with Select Toxins, including work below the permissible limit, must be registered with the Inter-Institutional Biological and Recombinant DNA Safety Committee.
Dual Use Research of Concern (DURC)
Dual use research of concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products or technologies that could be directly misused to pose a significant threat with broad consequences to public health and safety, agricultural crops and other plants, animals, the environment or national security.
The U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern describes the policies, practices and procedures required to ensure that DURC is identified and risk mitigation measures are implemented. A brief overview of DURC can be found here.
- Enhances the harmful consequences of the agent or toxin
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification
- Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
- Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
- Alters the host range or tropism of the agent or toxin
- Enhances susceptibility of a host population to the agent or toxin
- Generates or reconstitutes an eradicated or extinct agent or toxin listed here.
What you need to know
Research with select agents and toxins is highly regulated by the Federal Select Agent Program and requires increased oversight. Contact the Biological Safety Officer at firstname.lastname@example.org or 225-578-4658 for additional information.