3/17/20 - Advance Notices of Proposed Rulemaking – Biennial Review
Today, the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published Advance Notices of Proposed Rulemaking (ANPRM) in the Federal Register regarding the biennial review and republication of the list of select agents and toxins. Public comments are being accepted for the next 60 days.
Please visit the following links for more information:
- HHS: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review
- USDA: Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
1/21/20 - Publication of the 2018 Annual Report of the Federal Select Agent Program
Today, the Federal Select Agent Program (FSAP) published its annual report of aggregate program data, the 2018 Annual Report of the Federal Select Agent Program.
Now in its fourth year, this report continues to provide the American public with insight into the regulatory activities of the program. The content includes a look at both the regulatory functions of FSAP, as well as compliance with the select agent regulations at laboratories across the nation. The report also highlights FSAP’s efforts to engage with the regulated community throughout the year in order to ensure regulatory compliance.
As in previous years, the report summarizes aggregate program data in areas such as:
- Numbers and types of registered entities
- Security risk assessments performed
- Number of inspections conducted
- Top registered select agents or toxins, by agency
- Key observations related to inspection findings and compliance with the select agent regulations
- Identifications and transfers of select agents or toxins
- Thefts, losses, and releases of select agents or toxins
- Publications and outreach activities
The annual publication of this report reflects the program’s ongoing commitment to increasing transparency and understanding of the program.
The full report, along with an infographic summarizing the key findings, is now available online.