- Annual Refresher Training
This interpretation clarifies what is meant by “annually” in regards to the annual refresher training required by the regulations.
- Gram Stained Slides Containing Select Agents
This interpretation answers questions about primary containment and exposure in regards to the preparation of gram stained slides of bacterial select agents, including Burkholderia psuedomallei.
- Regulatory Interpretation for “SRA approved laboratorians working
at unregistered facilities with excluded levels of toxins”
This regulatory interpretation clarifies requirements for SRA-approved laboratorians working with excluded levels of select toxins at unregistered facilities.
- Requirement for Inactivation Certificates and Intra-Entity Transfers
This interpretation provides clarification regarding requirements for inactivation certificates for an intra-entity transfer.
- Signature by “Principal Investigator” on Inactivation Certificates
This interpretation clarifies the requirements for a Principal Investigator signature on inactivation certificates.
- Surrogate Strains Which Can Be Used to Validate Inactivation Procedures
This interpretation elaborates on the allowance of the use of surrogate strains to validate inactivation procedures.
- Synthetically Created DNA Sequence
This interpretation explains which synthetically created DNA sequences are regulated.
- Transfer of Excluded Toxins
This interpretation clarifies transfers involving excluded toxins.
- Waste Disposal of Select Agents and Toxins
This interpretation provides clarification regarding the decontamination or destruction procedures of select agent or toxin material intended for waste disposal.
To submit an interpretation request, an individual submits the request to the Federal Select Agent Program. The request should contain the regulatory requirement of concern, issues regarding the application of the regulatory requirement, and where appropriate, the requestor’s desired outcome.
Division of Select Agents and Toxins
1600 Clifton Road, NE, Mailstop H21-7
Atlanta, GA 30329
Agriculture Select Agent Services
4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
Phone: 301-851-3300 option 3 (voice only)