Preparing for Inspection

The Federal Select Agent Program has posted inspection checklists to assist entities with preparing for an inspection.

Please also view the SA Gram dated July 19, 2012 for more information regarding FSAP’s policy on verifying inspectors and an entity’s request to sign a confidentially agreement.

Inspection Checklists

To ensure that entities are complying with the requirements of the select agent regulations, the Federal Select Agent Program (FSAP) inspects entities using standardized checklists to certify that laboratories have the appropriate safety and security measures in place. These checklists are designed based on provisions outlined in the select agent regulations and nationally recognized standards (e.g., Biosafety in Microbiological and Biomedical Laboratories (BMBL) and NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules).

The Federal Select Agent Program Laboratory Examination Tool (FSAP-LET), available as a download for mobile devices, contains these checklists and was designed to provide laboratory managers and biosafety personnel with a tool to assist with performing internal laboratory inspections.

For those who do not wish to use the app, the regulatory checklists are also available for download below. Please note:

• The biosafety checklists should be used as companion documents based on the laboratory safety level (e.g., Biosafety General and BSL-3).
• Additional agent-specific checklists are available by accessing FSAP-LET.

Regulatory Checklists