Guidance on the Inventory of Select Agents and Toxins: Record Maintenance
Section 17(c) requires the entity to maintain all long term storage records for 3 years. 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 information locations contain information related to select agent regulation requirements, FSAP will only review the relevant portions of those documents.
Record of Final Disposition
Section 17 (a)(1)(v) requires an entity to maintain a record of the select agent used, purpose of use, and, when applicable, final disposition for all long-term storage select agent materials that are no longer in their possession. Examples of final disposition may include transfer of material to another registered entity or investigator, consumption of the material during an experiment, or intentional destruction of the material. The disposition can be included with an entity’s existing recordkeeping system (e.g., inventory spreadsheet).