|Last Updated: Thursday, August 22, 2013|
The Federal Select Agent Program has posted the inspection checklists in order for the regulated entities to have access to one of the tools used during select agent site-inspections. To ensure that entities are complying with the requirements of the select agent regulations, the Federal Select Agent Program inspects entities using these standardized checklists to certify that laboratories have the appropriate measures in place to deter the unauthorized access, theft, loss, or release of select agents. The biosafety checklists are derived from the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, NIH Guidelines for Research Involving Recombinant DNA Molecules, USDA Agricultural Research Service (ARS) Facility Design Standards (DM 242.1), Guidance on the Use of Infectious Waste Treatment and Radiation Facilities Outside of Registered Space, and the ARS Directive on Biohazardous Waste Decontamination, Management, and Quality Control at Laboratories and Technical Facilities (DR 9630-001). These checklists will be updated as needed.
The agent specific enhancement checklists contain additional requirements which were developed upon consultation with Federal subject matter experts based on their knowledge and experience on the risk of the agents. These additional requirements need to be considered when conducting work with these agents. An entity should provide alternative and/or equivalent mitigation measures consistent with the risk of the work they are doing if they are not able to meet these enhanced requirements. Please direct any questions or comments to email@example.com or firstname.lastname@example.org.
APHIS-CDC Responsible Official (Section 9) and Registration (Section 7) Checklist(PDF 53KB)
BSL3Ag Checklist(PDF 146KB)
|*Website is being revamped based on Revised Select Agent regulations.
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