Regulatory Interpretations
- 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: Constructs of Botulinum Neurotoxin GenesThis interpretation clarifies which constructs containing genes encoding botulinum neurotoxin would be subject to the select agent regulations as outlined and in 42 CFR § 73.3(c)(2).
- 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: 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: Interpretation on mRNA Subject to the Select Agent and Toxin Regulations as Outlined in 42 CFR §73.3(c)(2)This interpretation clarifies whether messenger RNA (mRNA) from Botulinum neurotoxin producing species of Clostridium would be subject to the select agent and toxin regulations as outlined in 42 CFR § 73.3(c)(2).
- 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 or Permissible Amounts of HHS ToxinsThis interpretation clarifies requirements for the transfer of less than or equal to permissible toxin amounts by or to entities registered to possess toxin covered on the permissible toxin amounts outlined under §73.3(d)(7).
- Regulatory Interpretation: Transfer of Excluded ToxinsThis interpretation clarifies transfers involving excluded toxins.
- Regulatory Interpretation: Validation of Inactivation Procedures for Regulated Nucleic AcidsThis interpretation verifies that any select agent virus must be subjected to a validated inactivation procedure and viability testing protocol.
- 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.
Interpretation Request
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.
Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road, NE, Mailstop H21-5
Atlanta, GA 30329
Telephone: 404-718-2000
Fax: 404-718-2096
Email: LRSAT@cdc.gov
Phone: 404-718-2000
Animal and Plant Health Inspection Service
Division of Agricultural Select Agents and Toxins
5601 Sunnyside Ave #AP-780-003
Beltsville, MD 20705
Telephone: 301-851-2070
Fax: 301-734-3652
Email: DASAT@usda.gov