- Regulatory Interpretation: Annual Refresher TrainingThis interpretation clarifies what is meant by “annually” in regards to the annual refresher training required by the regulations.
- Regulatory Interpretation: Gram Stained Slides Containing Select AgentsThis 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: FSAP-Approved Laboratorians Working at Unregistered Facilities with Excluded Levels of ToxinsThis regulatory interpretation clarifies requirements for FSAP-approved laboratorians working with excluded levels of select toxins at unregistered facilities.
- Regulatory Interpretation: Requirement for Inactivation Certificates and Intra-entity TransfersThis interpretation provides clarification regarding requirements for inactivation certificates for an intra-entity transfer.
- Regulatory Interpretation: Signature by “Principal Investigator” on Inactivation CertificatesThis interpretation clarifies the requirements for a Principal Investigator signature on inactivation certificates.
- Regulatory Interpretation: Surrogate Strains Which Can Be Used to Validate Inactivation ProceduresThis interpretation elaborates on the allowance of the use of surrogate strains to validate inactivation procedures.
- Regulatory Interpretation: Synthetically Created DNA SequenceThis interpretation explains which synthetically created DNA sequences are regulated.
- Regulatory Interpretation: Transfer of Excluded ToxinsThis interpretation clarifies transfers involving excluded toxins.
- Regulatory Interpretation: Waste Disposal of Select Agents and ToxinsThis 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.
Animal and Plant Health Inspection Service
Division of Agricultural Select Agents and Toxins
4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737