2021 SA Grams

The Federal Select Agent Program (FSAP) has updated its eFSAP Form 1 Amendment Instructions and posted the new document to the FSAP website.  Sections on modifying an unassigned room or suite, modifying a select agent or toxin strain or serotype, removing a room or suite, and adding personnel were updated based on current eFSAP instructions.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@cdc.gov.

The Division of Agricultural Select Agents and Toxins (DASAT) has issued a policy statement regarding personal quarantine for individuals working with, or in proximity to, specific Veterinary Services (VS) select agents.  The new policy is available here.

In short, the policy statement contains the following information:

The select agent and toxin regulations require that a biosafety plan include biosafety and containment procedures sufficient to contain the select agent or toxin (9 C.F.R. § 121.12(b)). It is DASAT policy that the biosafety plan for African swine fever virus, classical swine fever virus, foot-and-mouth disease virus, highly pathogenic avian influenza virus, rinderpest virus, and virulent Newcastle disease virus include a personal quarantine policy.  A personal quarantine policy mitigates the ease with which these viruses can be spread by restricting personnel from coming in contact with susceptible species after having performed work with, or in proximity to, these VS select agents. The policy statement includes the conditions for a personal quarantine policy and the minimum quarantine time periods. DASAT will consider the inclusion of a personal quarantine policy when evaluating the adequacy of the biosafety and containment procedures for the aforementioned VS select agents.

A draft version of the policy statement was previously shared with the regulated community for review and input prior to being finalized.  The final policy statement does not reflect any major changes from the draft version.

If you have any questions regarding this email, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov.

This a reminder that section 18 of the select agents and toxins regulations provides that, without prior notification, representatives of the HHS Secretary and the APHIS Administrator (FSAP inspectors) shall be allowed to inspect any site at which activities regulated by the federal select agents and toxins regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331) are conducted and shall be allowed to inspect and copy any records relating to the activities covered by said regulations.

• All FSAP inspectors will, where required, have the appropriate security clearance for the entity to be inspected. For those entities requiring pre-access verification, FSAP will have shared with the entity confirmation of the security clearance prior to the beginning of the inspection.
• All FSAP inspectors will have undergone the appropriate medical clearance for the entity to be inspected. Each inspector has been certified to not have any underlying medical conditions which would interfere with performing his/her duties. Each individual also maintains a copy of his/her immunization records and his/her respirator fit testing card. Entities may not require inspectors to participate in an entity medical surveillance program.
• All FSAP inspectors will adhere to FSAP’s policy for safeguarding select agent and toxin information.
• The FSAP inspector will identify himself or herself by their personal identity verification (PIV) card (his/her official government identification card).
• The FSAP inspector is not allowed to surrender his/her PIV card to the entity or exchange the PIV card for the entity’s identification badge.
• An entity is not allowed to copy the PIV card.
• The FSAP inspector will not provide an entity with any personal identification (e.g., a driver’s license, social security number).
• The FSAP inspector is not authorized to sign and will not sign any type of an entity confidentiality agreement.
• The FSAP inspector is not authorized to sign and will not sign any type of document releasing the entity from any liability.

The failure to allow an FSAP inspector access to a registered entity to conduct an inspection is a violation of federal regulations that may result in the imposition of civil penalties. Such failure may result in the immediate suspension or revocation of the entity’s approval to possess and use select agents and toxins.

If you have any questions regarding this email, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

Today, the Centers for Disease Control and Prevention (CDC)’s Division of Select Agents and Toxins published an Interim Final Rule adding SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins.  In addition, the work to create this chimeric virus is a ‘restricted experiment’ and requires prior approval from CDC before performing the experiment.

The regulation, available at https://www.federalregister.gov/d/2021-25204, was published in the Federal Register and CDC will accept public comments on the addition of the agent for the next 60 days.  Comments on the Interim Final Rule should be submitted via the regulations.gov website; a direct link is available here.

HHS/CDC believes that immediate regulatory oversight of these experiments and the resulting chimeric viruses is essential to protect the public from the potential consequences of a release of these viruses. Once the 60-day public comment period has closed, CDC will consider the comments received.  In the meantime:

• Within 30 days of the publication of the notice in the Federal Register (by December 17, 2021), any individual or entity that possesses SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors must provide notice to the Federal Select Agent Program regarding their possession of this agent.
• By 90 days after the publication (by February 15, 2022), any individual or entity that intends to continue to possess, use, or transfer this agent will be required to either register in accordance with the select agent regulations (42 CFR part 73), or amend their current registration [in accordance with § 73.7(h)] and meet all of the requirements of the select agent regulations.

If you have any questions, please contact CDC’s Division of Select Agents and Toxins at lrsat@cdc.gov or 404-718-2000.

The Federal Select Agent Program (FSAP) has been asked to notify the regulated community of the following on behalf of the Federal Bureau of Investigation/Criminal Justice Information Service/Bioterrorism Risk Assessment Group (BRAG):

A revised FD-961 form has been approved by the Office of Management and Budget (OMB) (OMB No. 1110-0039 [Exp. 07-31-2024]) and should now be used when submitting security risk assessments.  BRAG will continue to accept the expired form, FD-961 (OMB No. 1110-0039 [Exp. 4-30-2021]), until December 4, 2021.  Previous versions of the FD-961 will not be accepted after this date and will result in return of the form to the submitter. This could result in the delay of processing an individual’s security risk assessment.

A link to the revised FD-961 form is also available on the FSAP website.

If you have any questions regarding the FD-961 form, please contact BRAG at 304-625-4900.

In 2021, due to the continuing COVID-19 pandemic and concerns for safety, the Federal Select Agent Program (FSAP) replaced its annual in-person workshop for Responsible Officials and Alternate Responsible Officials with a series of six webinars.  Each webinar was designed to provide participants with information related to compliance with the select agent regulations, as well as 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.

The Federal Select Agent Program (FSAP) inspects entities using standardized checklists to ensure compliance with the select agent regulations.  FSAP also makes inspection checklists available to the regulated community to assist with preparation for an inspection.

As shared via SA Gram on May 19, 2021, FSAP has updated its inspection checklists to reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL), and we wish to remind you that these inspection checklists are now being used for all inspections, as of October 1, 2021.

The updated inspection checklists are available on the FSAP website.

Please note that the Federal Select Agent Program Laboratory Examination Tool (FSAP-LET) mobile app is still in the process of being updated to reflect these changes to the checklists.

The Federal Select Agent Program (FSAP) will host two multi-agency public webinars this fall to provide guidance and information regarding the submission of APHIS/CDC Form 2, APHIS/CDC Form 3 and APHIS/CDC Form 4.

The two webinars, which will each cover the same agenda, will take place at the following dates and times:

• October 6, 2021 from 10:00 am to 12:30 pm EDT
• November 3, 2021 from 1:30 pm to 4:00 pm EDT

All stakeholders from the FSAP-registered and non-registered communities are invited to attend.

Registration instructions and the webinar agenda can be found here on the FSAP website.  Registration is limited to the first 1000 participants.

Registration will be confirmed by email and registrants will receive a link to enter the meeting prior to the date of the webinar.

Today, the Federal Select Agent Program (FSAP) published its sixth annual report of aggregate program data, the 2020 Annual Report of the Federal Select Agent Program.  The report, which summarizes data for calendar year 2020, is a part of FSAP’s continued efforts to provide the American public with insight into the regulatory activities of the program and reflects FSAP’s ongoing commitment to transparency.

As in previous years, the content includes a look at the regulatory functions of FSAP, as well as compliance with the select agent regulations at laboratories across the nation.  The report highlights FSAP’s efforts to engage with the regulated community throughout the year to ensure regulatory compliance.  This year, it also provides insight into key changes made to program operations during the COVID-19 pandemic.

Once again, the content of the report underscores that overall, most laboratories registered with the program are compliant with the regulations, and none of the small number of reported incidents during the year resulted in a significant 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.

On March 3, 2016, the Federal Select Agent Program (FSAP) published an SA Gram entitled “Regulatory Oversight of Pigeon Paramyxovirus (PPMV-1)” that announced the following:

[E]ffective March 3, 2016 and until further notice, the Federal Select Agent Program (FSAP) will not apply the requirement in 9 CFR Section 121.7, “Registration and related security risk assessments” of the select agent regulations for work with [Pigeon Paramyxovirus (PPMV-1)]. The FSAP’s exercise of enforcement discretion regarding work with PPMV-1 is temporary and applied to address a critical shortage in the manufacture of a killed vaccine for non-poultry species.

FSAP is revoking the aforementioned exercise of enforcement discretion regarding work with PPMV-1. FSAP has determined that this exercise of enforcement discretion is no longer needed as this was a temporary measure to address a select agent regulation technical amendment allowing for exclusion of properly identified PPMV-1 from the select agent regulations. The technical amendment was finalized and provides exclusion of properly identified PPMV-1 from select agent regulation. Therefore, the March 3, 2016 SA Gram entitled “Regulatory Oversight of Pigeon Paramyxovirus (PPMV-1)” is hereby withdrawn and has been removed from the FSAP website.

As stated in 9 CFR § 121.3(d)(9), properly identified PPMV-1 isolated from a non-poultry species is excluded from the requirements of the select agent and toxin regulations in 9 CFR Part 121. PPMV-1 is a species-adapted APMV-1 virus which is endemic in pigeons and doves in the United States and can be identified through demonstration of the characteristic amino acid signature at the fusion gene cleavage site along with accompanying phylogenetic analysis confirming classification as a PPMV-1.

The Federal Select Agent Program (FSAP) has updated its Incident Response Plan Guidance and posted the new document to the FSAP website.  Updates include:

• Adding fire, workplace violence, and power outage incidents to the Section 14b table as examples of what the incident response plan should describe.
• Revising occupational exposure and discovery incident examples on the Immediate Response table to reflect accurate immediate responsibilities.

Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its annual analysis of inspection report timeliness data, the 2020 FSAP Inspection Report Processing Annual Summary.

This FSAP analysis finds continued program improvement in providing timely feedback to entities following an inspection, with all final inspection reports sent to entities in 2020 within FSAP’s goal of 30 business days.

Key findings include the following:

• FSAP issued 157 final inspection reports in 2020 – with 100 percent issued within the target timeframe of 30 business days.  The average was 19.5 days.
• CDC’s Division of Select Agents and Toxins issued 125 final inspection reports at an average of 21.1 days, and APHIS’s Division of Agricultural Select Agents and Toxins issued 32 final inspection reports at an average of 13.3 days.
• Nearly all (7 out of 8) immediate action observations were issued within the target timeframe of 10 business days.  The average was 7 days.

FSAP made several important changes to the inspection process during the COVID-19 pandemic.  Beginning in April 2020, FSAP adjusted its inspection processes by adopting remote or hybrid (i.e., part on-site and part remote) inspections, due to travel restrictions and for the safety of FSAP inspectors and regulated entity staff.  These changes did not adversely impact timeliness or result in delays in issuing inspection reports, but rather, helped FSAP to become more efficient and continue to carry out its program mission despite the pandemic.

For more information, please see the full report, available at here.

The Federal Select Agent Program (FSAP) has finalized a user manual for the electronic Federal Select Agent Program (eFSAP) information system. The manual is intended to assist entities in using eFSAP and is now available on the FSAP website here [PDF – 917 KB].

A draft version of the user manual was previously shared with the regulated community for review and input prior to being finalized. FSAP did not receive any comments regarding the manual, and therefore, did not make any changes to the final document.

The Federal Select Agent Program (FSAP) will host two multi-agency public webinars this fall to provide guidance and information regarding the submission of APHIS/CDC Form 2, APHIS/CDC Form 3 and APHIS/CDC Form 4.

The two webinars, which will each cover the same agenda, will take place at the following dates and times:

• October 6, 2021 from 10:00 am to 12:30 pm EDT
• November 3, 2021 from 1:30 pm to 4:00 pm EDT

All stakeholders from the FSAP-registered and non-registered communities are invited to attend.

Registration instructions can be found here on the FSAP website, and the webinar agenda will be posted to this same webpage once finalized.  Registration is limited to the first 1000 participants.

Registration will be confirmed by email and registrants will receive a link to enter the meeting one week prior to the date of the webinar.

The Federal Select Agent Program (FSAP) is pleased to announce two updates to the APHIS/CDC Form 2, Request to Transfer Select Agents and Toxins, in the electronic Federal Select Agent Program (eFSAP) information system.

1. The update removes question 4 regarding the PPQ permit number.  The U.S. Department of Agriculture/Animal and Plant Health Inspection Service/Plant Protection and Quarantine (PPQ) has determined that a PPQ 526 permit (Permit to Move Live Plant Pests, Noxious Weeds, Soil, and Prohibited Plants) is no longer required for the importation or interstate/intrastate movement of the PPQ select agents listed in 7 CFR 331.3.
2. The update also removes the block for the transfer extension from the APHIS/CDC Form 2, as the regulations do not support transfer extension.

In 2020, the Federal Select Agent Program held a multi-agency public webinar on reporting requirements related to the select agent regulations.  During the event, among other topics, speakers discussed the submission of the APHIS/CDC Form 2, APHIS/CDC Form 3, and APHIS/CDC Form 4.  The presentations are now available on the FSAP website.

At the request of the Federal Bureau of Investigation/Criminal Justice Information Service/Bioterrorism Risk Assessment Group (BRAG), the Federal Select Agent Program (FSAP) would like to notify the regulated community that the FD-961 form used by individuals to submit information for security risk assessments has expired.  However, BRAG will continue to accept this expired form, FD-961 (OMB No. 1110-0039 [Exp. 4-30-2021]) until further notice.

The Federal Select Agent Program (FSAP) inspects entities using standardized checklists to ensure compliance with the select agent regulations.  FSAP also makes inspection checklists available to the regulated community to assist with preparation for an inspection.

FSAP has updated its inspection checklists to reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). The updated inspection checklists are now available on the FSAP website. In addition, to reflect changes, the Federal Select Agent Program Laboratory Examination Tool (FSAP-LET) mobile app is also in the process of being updated.

FSAP will use the new checklists for inspections after October 1, 2021.  In the interim, the current inspection checklists will also remain on the website until this time.

The Federal Select Agent Program (FSAP) has updated guidance for the Occupational Health Program. Revisions included removal of certain suggested information provided on emergency contact cards.

The Federal Select Agent Program (FSAP) has determined that the ASFV-G-Δ9GLΔMGF 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-Δ9GLΔMGF strain does not pose a threat to animal health or animal products.

Additional information regarding the specific excluded strain can be found at here.

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 (FSAP) has updated the Guidance to the Select Agent Regulations Training Requirements to add a section on non-FSAP-approved individuals.

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 Clarification.

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 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.