2021 SA Grams
The Federal Select Agent Program (FSAP) has determined that the ASFV-G-ΔI177L ΔLVR strain of African swine fever virus is excluded from the requirements of the select agent regulations. This decision was made based upon information provided by the entity requesting the exclusion, consultation with subject matter experts, and a review of published studies. After completion of this review, FSAP concluded that the ASFV-G-ΔI177L ΔLVR strain does not pose a threat to animal health or animal products.
Additional information regarding the specific excluded strain can be found here.
The Federal Select Agent Program requested clarification from the Department of Transportation (DOT) on whether a “technical name” and/or “specific name” is required to be marked on package containing a select agent and toxin.
The DOT clarification can be found at Department of Transportation Clarificationpdf iconexternal icon.
Following Office of Management and Budget (OMB) approval, the Federal Select Agent Program (FSAP) has posted updated APHIS/CDC Forms 2-5 to its website (available here) and eFSAP for use by the regulated community. Changes were made to the forms to improve data collection and clarify questions. No changes were made to APHIS/CDC Form 1.
On January 15, 2021, the Federal Select Agent Program (FSAP) published notices in the Federal Register the request for comments on its new draft policy, Biosafety for Large Animal Study-Related Activities with B. abortus and B. suis Using Outdoor Containment Spaces. The 60-day comment period will end on March 16, 2021.
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.
Administrator Michon Oubichon. Moving AgSAS to ERCS addresses a recommendation from the Government Accountability Office’s “High-Containment Laboratories: Coordinated Actions Needed to Enhance the Select Agent Program’s Oversight of Hazardous Pathogens” audit (GAO 18-145). The recommendation for the Animal and Plant Health Inspection Service (APHIS) Administrator to change and formally document the reporting structure for the APHIS component of the Federal Select Agent Program (FSAP) from the APHIS director of the program to the Administrator of APHIS.
As part of this transition, APHIS is renaming AgSAS to the Division of Agricultural Select Agents and Toxins (DASAT), which betters aligns with FSAP nomenclature.
We want to make regulated community aware of these changes and assure you that this organizational change will not affect your regulatory oversight.
Please note that http://www.selectagents.gov/external iconexternal icon is in the process of being updated to reflect this change.
In 2020, due to the COVID-19 pandemic, the Federal Select Agent Program (FSAP) replaced its annual in-person workshop for Responsible Officials and Alternate Responsible Officials with a series of five webinars. Each webinar was designed to provide participants with information related to compliance with the select agent regulations, and updates from FSAP on a variety of topics.
The webinar presentations have been posted to the FSAP website and are now available for download here.