What’s New: 2020

The Federal Select Agent Program (FSAP) wishes to share a preview of its new draft policy, Biosafety for Large Animal Study-Related Activities with B. abortus and B. suis Using Outdoor Containment Spaces, with the regulated community prior to posting the draft policy in the Federal Register.  FSAP is sharing this proposed policy for review and to provide a heads up on the upcoming opportunity to provide feedback by submitting comments through the Federal Register process.

The draft policy states that biosafety plans for large animal B. abortus or B. suis outdoor containment studies within endemic areas of the agents should contain sufficient information for FSAP to determine that the study can be safely conducted in compliance with the select agent and toxin regulations. Please click here to view the draft policy in its entirety.

Today, the Federal Select Agent Program (FSAP) published its fifth annual report of aggregate program data, the 2019 Annual Report of the Federal Select Agent Program, as part of the program’s continued efforts to provide the American public with insight into the regulatory activities of the program.  The annual publication of this report reflects FSAP’s continued commitment to increasing transparency and understanding of the program.

As in previous years, 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.  In addition, the report highlights FSAP’s efforts to engage with the regulated community throughout the year to help ensure regulatory compliance.

The findings underscore that overall, most laboratories registered with the program are compliant with the regulations, and none of the relatively small number of reported incidents during the year resulted in a risk to public or agricultural health.

The report summarizes aggregate program data in areas such as:

• Numbers and types of registered entities, as well as amendments to registrations
• Top registered select agents or toxins
• Security risk assessments performed
• Number of inspections conducted
• Key observations related to inspection findings and compliance with the select agent regulations
• Reported thefts, losses, and releases of select agents or toxins
• Identifications and transfers of select agents or toxins
• Publications and outreach activities

The full report, along with an infographic summarizing the key findings, is now available here.

Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its annual analysis of inspection report timeliness data, the 2019 FSAP Inspection Report Processing Annual Summary.

The analysis finds that FSAP continues to send nearly all inspection reports to entities within the program’s goal of 30 business days following an inspection, underscoring the program’s continued commitment to provide timely feedback.

Key findings include the following:

• FSAP issued 193 final inspection reports in 2019 – with 97 percent overall (188/193) issued within the target timeframe of 30 business days. The average was 21 days.
• Among reports issued by CDC’s Division of Select Agent and Toxins (DSAT), 98 percent met this goal, and among reports issued by APHIS’s Agriculture Select Agent Services (AgSAS), 95 percent met this goal.
• All 7 immediate action reports were issued within the target timeframe of 10 business days. The average was 8 days.
• For the small number of reports that were delayed (5 total), analysis by inspection type found that the most common inspections also continue to be the most commonly delayed report types (verification and renewal inspections).

FSAP will continue to assess this information on an annual basis, including looking at reasons for any delays in order to identify potential opportunities for improvement. The program remains committed to issuing final inspection reports within the target timeframe of 30 business days.

For more information, please see the full report.

A notice has been published in the Federal Register to seek public comment on the Federal Select Agent Program’s request for continued approval by the Office of Management and Budget to collect select agent and toxin information through the use of:

• Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1)
• Request to Transfer Select Agents or Toxins (APHIS/CDC Form 2)
• Incident Notification and Reporting (Theft, Loss, or Release) (APHIS/CDC Form 3)
• Reporting the Identification of a Select Agent or Toxin (APHIS/CDC Form 4)
• Request for Exemption of Select Agents and Toxins for an Investigational Product (APHIS/CDC Form 5)

The Federal Register notice and information on how to submit public comments can be found here.  The public comment period ends on June 2, 2020.

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

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.