Guidance on the Inventory of Select Agents and Toxins: Record Maintenance

Section 17(c) outlines the requirements for the maintenance of complete records involving select agents and toxins. Upon request, the entity must be able to promptly produce those records as well as any information related to the records requirements that is not contained in a record. Such information may be located in:

  • Biocontainment certifications
  • Laboratory notebooks
  • Institutional biosafety and/or animal use committee minutes and approved protocols
  • Records associated with occupational health and suitability programs

If any of the above documents contain information related to select agent regulation requirements, FSAP will only review the relevant portions of those documents.

Records required to comply with the select agent regulations must be maintained for 3 years, following final disposition of material.