Select Agent (SA) Grams

2020 SA Grams

7/31/20 - Multi-Agency Informational Meeting (Webinar) to Discuss Select Agent and Toxin Reporting Requirements

The Federal Select Agent Program (FSAP) will host a multi-agency public webinar on September 23, 2020 from 11 a.m. to 3 p.m. EDT to provide guidance and information regarding the submission of APHIS/CDC Form 2, APHIS/CDC Form 3 and APHIS/CDC Form 4.  Representatives from the U.S. Department of Transportation and the Minnesota Department of Health will have additional presentations.  All stakeholders from the FSAP-registered and non-registered communities are invited to attend the event.

The webinar agenda and registration instructions can be found on the FSAP website here. 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.   

If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.




  • 6/30/20 - Publication of the 2019 FSAP Inspection Report Processing Annual Summary

    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.

    If you have any questions about the report, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

  • 6/25/20 - eFSAP training on update just released

    The Federal Select Agent Program (FSAP) recently announced the deployment of major system updates to the electronic Federal Select Agent Program (eFSAP) information system.  eFSAP information system users are encouraged to sign up for one of our upcoming training webinars covering recent updates to the system.  During the webinars we will discuss updates to the notifications table, the general discussion page, and APHIS/CDC Form 1, Sections 6, 7A/C and B, as well as APHIS/CDC Form 2.

    Sessions will be held via webinar at the following dates/times:

    • July 7: 1-2:30 pm EDT
    • July 8: 1-2:30 pm EDT
    • July 9: 1-2:30 pm EDT

    To register for a session, please visit the eFSAP updates training registration page.

    Please note: as with every eFSAP system update, users must clear their internet browser cache in order for the system to function properly.  Instructions can be found on the eFSAP Resource Center page.  

    If you experience errors, have questions, or have issues with SAMS access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

  • 6/24/20 - eFSAP System Update Just Released: 1) Redesigned APHIS/CDC Form 1 Section 7B, 2) APHIS/CDC Form 1 Sections 4, 6, and 7A/C Updates, 3) Ability to Cancel APHIS/CDC Form 2 Transfer Requests, 4) General Discussion Updates, and 5) Notifications Table Updates

    The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another major update to the electronic Federal Select Agent Program (eFSAP) information system. 

    Beginning June 24, 2020, eFSAP users will notice the following system updates:

    • Redesigned APHIS/CDC Form 1 Section 7B
      • Section 7B has been redesigned to support bulk-editing and bulk-deleting of strains/serotypes.
      • Upon addition or modification of a strain/serotype, detailed information is no longer required.  Rather, users are provided with a simple drop-down list of the most common strains/serotypes for the agent/toxin that is being added or modified.
      • If the entity has multiple entries of the same strain/serotype, the new 7B table automatically groups those rows together in an expandable/collapsible configuration to make the 7B table more compact and easier to navigate.

    • APHIS/CDC Form 1 Sections 4, 6, and 7A/C Updates
      • Section 4 now supports the withdrawal of expired personnel and also provides the user with a drop-down list of common reasons for withdrawal.
      • Section 6 now allows for the administrative editing of buildings, rooms, or suites that are not currently on an approved work objective.
      • Section 7A/C now permits the modification or removal of suspended work objectives. Enhancements have also been made to work objective histories and Section 7A/C notifications.

    • Ability to Cancel APHIS/CDC Form 2 Transfer Requests
      • The recipient entity of a Form 2 transfer request has the ability to cancel the transfer from Form 2 Section 1.

    • General Discussion Updates
      • The general discussion window now features pagination for faster loading times.
      • General discussion now has a search feature to find messages by date, keyword, or user.

    • Notifications Table Updates
      • The Notifications table now includes a selectable filter to quickly find notifications related to either amendments, inspections, or APHIS/CDC Forms 1, 2, 3, or 4.

    For more information, please review the tutorial with screenshots of the new features attached to this message. 

    FSAP would like to thank the regulated community for its continued feedback regarding eFSAP system functionality.  We look forward to delivering continued improvements based upon your suggestions.

    If you experience errors, have questions, or have challenges with access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

  • 5/09/20 - Updated guidance on the transfer of select agents and toxins

    The Federal Select Agent Program (FSAP) has updated the Guidance on the Transfer of Select Agents and Toxins to include electronic Federal Select Agent Program (eFSAP) information, update links, and remove appendices.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

  • 4/24/20 - Exclusion of African swine fever virus, ASFV-G-ΔI177L

    The Federal Select Agent Program (FSAP) has determined that the ASFV-G-ΔI177L strain of African swine fever virus is excluded from the requirements of the select agent regulations. We made our decision based upon information provided by the entity requesting the exclusion, consultations with subject matter experts and review of published studies. After completion of our review, FSAP concluded that the ASFV-G-ΔI177L strain does not pose a threat to animal health or animal products.

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

    If you have any questions regarding this email, please contact 301-851-3300 option 3 (voice only) or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

  • 4/22/20 - Exclusion of attenuated strains of Burkholderia pseudomallei, Clostridium botulinum, and Yersinia pestis, and modified toxin of Botulinum neurotoxin

    Based upon consultations with subject matter experts and a review of relevant published studies and information provided by the entities requesting the exclusions, the Federal Select Agent Program has determined that the following attenuated strains and modified toxin are not subject to the requirements of the select agent regulations:

    • Burkholderia pseudomallei strain PBK001 (ΔtonB Δhcp1)
    • Clostridium botulinum Beluga Ei strain
    • Yersinia pestis CO92 strain ΔlppΔmsbBΔpla 
    • Catalytically inactive Botulinum neurotoxin (ciBoNT)/D

    In addition, the exclusions were revised for clarity for Anhydrotetrodotoxin (a derivative of wild-type tetrodotoxin), South American genotypes of Eastern Equine Encephalitis virus, and Burkholderia pseudomallei strain 576mn.  

    Additional information regarding the excluded strains and toxins can be found here.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.


  • 4/10/20 - Updated FAQs Regarding Security Risk Assessments

    The Federal Select Agent Program (FSAP) has updated its Frequently Asked Questions (FAQs) regarding security risk assessments.  See https://www.selectagents.gov/faq-risk.html for the updated FAQs.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.


  • 4/09/20 - Select Agent Forms Available for Public Comment

    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. 

  • 4/03/20 - Updated eFSAP Amendment Instructions

    The Federal Select Agent Program (FSAP) has updated its electronic Federal Select Agent Program (eFSAP) Resource Center to include two new tools to assist users in requesting APHIS/CDC Form 1 registration changes.  The new resources include a full instruction document, as well as an appendix highlighting the most frequently requested changes.  Updates have also been made to other materials throughout the page to reflect screen shots of the current eFSAP system.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

  • 4/02/20 - Web Posting of Inspection Checklists

    In June 2019, the Federal Select Agent Program (FSAP) introduced the Federal Select Agent Program Laboratory Examination Tool (FSAP-LET) app. The app is designed as a tool to assist laboratory managers and biosafety personnel with performing internal laboratory inspections and is available as a download for mobile devices at the link above. The app contains checklists that are used by FSAP inspectors. The checklists cover a variety of areas such as biosafety, security, training, and incident response. 

    In addition, FSAP is making the inspection checklists available for download as individual PDF files here

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

  • 3/19/20 - Electronic Federal Select Agent Program (eFSAP) information system – training on update just released

    The Federal Select Agent Program (FSAP) recently announced the deployment of major system updates to the electronic Federal Select Agent Program (eFSAP) information system.  eFSAP information system users are encouraged to sign up for one of our upcoming training webinars covering recent updates to the system. During the webinars we will discuss new and redesigned features such as: the principal investigator user role, entity admin center, redesign of the landing page, and printable entity registration certificate.

    Sessions will be held via webinar at the following dates/times:

    • March 23: 1-2 pm ET
    • March 25: 1-2 pm ET
    • March 26: 1-2 pm ET

    To register for a session, please visit the eFSAP updates March 2020 training registration page.

    Please note: as with every eFSAP system update, users must clear their internet browser cache in order for the system to function properly.  Instructions can be found on the eFSAP Resource Center page.  

    If you experience errors, have questions, or have issues with SAMS access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.


  • 3/18/20 - eFSAP System Update Just Released: 1) Principal Investigator User Role, 2) Entity Admin Center, 3) Landing Page Redesign, and 4) Printable Registration Certificate

    The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another major update to the electronic Federal Select Agent Program (eFSAP) Information System. 

    Beginning March 18, 2020, eFSAP users will notice the following system updates:

    Principal Investigator User Role

    • Responsible Officials (ROs) can now request system access for their Principal Investigators (PIs).
    • Upon accessing eFSAP, PIs are able to view limited information in Form 1 Section 7A/C and 7B (PIs can only see strains/serotypes and work objectives to which they are currently assigned).
    • PIs are able to view, edit, and save (but not submit) Form 1 Section 7A/C amendments (provided they are listed as a PI on the work objective the amendment is adding or modifying).

    Entity Admin Center

    • RO/ARO users now have access to a dedicated entity admin center.
    • Within the admin center, the RO/AROs will see a list of all users with access to their select agent and toxin information.
    • Each user's role is also displayed; read-only and super-admin user's roles can be modified directly.

    Redesigned Landing Page

    • Navigation links have been moved to the page header.
    • The names and contact information of the entity’s primary and secondary FSAP points of contact have been added.

    Printable Registration Certificate

    • Your Certificate of Registration is now available for instant viewing/downloading/printing.

    For more information, please review the tutorial with screenshots of the new features attached to this message. 

    FSAP would like to thank the regulated community for its continued feedback regarding eFSAP system functionality. We look forward to delivering continued improvements based upon your suggestions. 

    Please note: as with every eFSAP system update, users must clear their internet browser cache/cookies in order for the system to function properly.  Instructions can be found on the eFSAP Resource Center page.  

    If you experience errors, have questions, or have challenges with access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.


  • 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:


    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.


  • 2/26/20 - Revised security plan guidance

    The Federal Select Agent Program (FSAP) has revised the Security Plan Guidance to update inventory language to match the Inventory Guidance and to correct editorial errors from the previous version.

  • 2/25/20 - Further clarification on which SARS viruses are regulated under the select agent regulations

    On February 18, 2020, the Federal Select Agent Program (FSAP) sent a notice to clarify that viruses identified as SARS-CoV are regulated by the select agent regulations, while viruses identified as SARS-CoV-2 are not currently regulated. 

    FSAP wishes to further clarify that the positive strand RNA genome of SARS-COV is also a select agent because this genomic material represents nucleic acids capable of generating infectious virus, SARS-CoV. 

  • 2/18/20 - Clarification on which SARS viruses are regulated under the select agent regulations

    On February 11, 2020, the International Committee on Taxonomy of Viruses (ICTV) announced that taxonomically, what has previously been referred to as 2019-nCoV should now be referred to as SARS-CoV-2.  The “Severe acute respiratory syndrome-related coronavirus: The species and its viruses – a statement of the Coronavirus Study Group” indicates that SARS-CoV-2 is not a descendent of SARS-CoV, but is genetically closely related. 

    The select agent regulations currently regulate viruses identified as SARS-CoV and not viruses identified as SARS-CoV-2.

    As the Federal Select Agent Program gains more information about the SARS-CoV-2, we will reassess the select agent status as needed.  Any changes in the select agent status of SARS-CoV-2 will be published in the Federal Register.

  • 2/14/20 - Revised policy statement regarding regulated genomes and guidance regarding the regulation of select agent and toxin nucleic acids

    The Federal Select Agent Program (FSAP) has issued a revised policy statement regarding laboratory work with  genomes capable of producing infectious virus of regulated Risk Group 3 and 4 (RG3 and RG4) select agents and Veterinary Services  select agents (VSsa) at one containment level lower than the infectious virus without RNA inactivation.  The policy was revised to allow entities that work with RG3 and VSsa genomic material in a BSL2 laboratory under biosafety and security requirements dictated by a risk assessment. 

    The revised policy replaces the previous FSAP policy statement on the subject (issued August 13, 2014) and is posted here.

    In addition, FSAP has revised the Guidance on the Regulation of Select Agent and Toxin Nucleic Acids to correct editorial errors, improve clarity and update the information related to a policy posted on our website.

  • 2/13/20 - Updated Responsible Official Knowledge Check

    The Federal Select Agent Program (FSAP) has updated the Knowledge Check Self-Exam (available here) for the Responsible Official (RO).  The self-exam serves as a tool for ROs and Alternate ROs to familiarize themselves with the regulatory responsibilities of an RO.  Additionally, while updating this tool, FSAP incorporated feedback received from the regulated community.

  • 2/12/20 - Exclusion of African swine fever viruses, ASFV-G-Δ9GL/ΔUK and ASFV-G-ΔMGF

    Based upon consultations with subject matter experts and a review of relevant published studies and information provided by the entities requesting the exclusions, the Federal Select Agent Program has determined that the ASFV-G-Δ9GL/ΔUK and ASFV-G-ΔMGF strains of African swine fever virus are excluded from the requirements of the select agent regulations because they do not pose a severe threat to animal health or animal products.

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

    If you have any questions regarding this email, please contact 301-851-3300 option 3 (voice only) or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

  • 1/27/20 - Update to Frequently Asked Question (FAQ) regarding positive identification of select agents

    In response to a recent request, the Federal Select Agent Program (FSAP) is clarifying the below Frequently Asked Question (FAQ) on whether a sample that has been serologically identified as suspect/positive for antibodies is considered to be a select agent. FSAP does not consider a test result identifying the presence of antibodies to select agent antigen(s) in a sample as positive identification of the select agent. 

    The newly updated FAQ is as follows:

    What test or procedure determines whether a select agent or toxin is contained in a specimen presented for diagnosis or verification?

    The test or procedure used to determine whether a select agent or toxin is contained in a specimen presented for diagnosis or verification will depend on the select agent or toxin, and whether the agent is identified at the genus or the genus/species level. A particular test or procedure used by an accredited laboratory, and/or disease program approved laboratory, and/or reference laboratory will have a recognized capability to make either a tentative or positive identification depending on the exactness of the identification needed. In some cases, an agent may need to be cultured for confirmatory test purposes and may also require specific disease program testing requirements. The Federal Select Agent Program (FSAP) does not consider a test result identifying the presence of antibodies to select agent antigen(s) in a sample as positive identification of the select agent. FSAP does not define which tests or procedures constitute positive identification of a select agent or toxin.

    The updated FAQ can be found on the FSAP website.

    If you have any questions regarding this email, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

  • 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.

    If you have any questions about the report, please contact APHIS/AgSAS at 301-851-3300 option 3 (voice only) or agsas@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.