2018 Federal Select Agent program Inspection report processing annual summary
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2018 Federal Select Agent program Inspection report processing annual summary

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    • Description:
      The 2018 Federal Select Agent Program Inspection Report Processing Annual Summary presents an analysis of the time frame for an entity registered with the program to receive a report after an on-site inspection during calendar year 2018 (CY2018). The Federal Select Agent Program (FSAP) uses this data to improve program performance in providing timely feedback to those registered entities that have received an on-site inspection. The target time frame to process and issue a final inspection report to an entity is 30 business days. Of the 194 final inspection reports issued in CY2018, 93% overall were within the 30-business day time frame.

      The Federal Select Agent Program (FSAP) regulates the possession, use, and transfer of biological select agents and toxins (BSAT)—such as Bacillus anthracis, avian influenza viruses, Ralstonia solanacearum, and botulinum neurotoxin—that have the potential to pose a severe threat to human, animal or plant health, or to animal or plant products. FSAP is managed jointly by the U.S. Department of Health and Human Services (HHS)/ Centers for Disease Control and Prevention (CDC)/ Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)/Agriculture Select Agent Services (AgSAS). HHS provides oversight for biological agents and toxins that have the potential to pose a severe threat to public health and safety. USDA provides oversight for biological agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. HHS and USDA jointly oversee biological agents and toxins which have the potential to pose a severe threat to both public health and safety and animal health and products, also known as overlap select agents and toxins.

      The select agent regulations (SAR) include biosafety/biocontainment, security, and incident response requirements that all registered entities must follow to ensure the safety and security of those working in laboratories and living in surrounding communities. An entity required to register with FSAP (i.e., an entity that possesses, transfers, or works with BSAT) is subject to the SAR and on-site inspections to review laboratory programs to ensure that appropriate biosafety/ biocontainment and security measures are in place.

      This report analyzes FSAP’s responsiveness in providing feedback to entities after an on-site inspection. While DSAT has issued annual summaries in the past three years, this is the first year the annual summary includes AgSAS timeliness data. Previous reports specific to DSAT activities are available on the FSAP website at https://www.selectagents.gov/publications.html.

      CS311039-A

      2018-FSAP-Inspection-Report-Processing-Annual-Summary_508.pdf

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