Select Agent (SA) Grams

2018 SA Grams

2/14/18 - RO Workshop Presentations Now Available

The Federal Select Agent Program (FSAP) recently posted presentations online from the November 28-30, 2017 in-person workshop for Responsible Officials held at the Animal and Plant Health Inspection Service headquarters in Riverdale, MD. The workshop provided participants with information about the new eFSAP information system portal, regulatory requirements for inactivation of select agents, and maintaining select agent regulatory compliance, as well as an opportunity to network with colleagues. The presentations are now available here.

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

2/14/18 - New FAQs on FSAP Website

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) on its website in order to clarify regulatory requirements in two areas:


Please see the corresponding web links for more information.

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




  • 2/13/18 - FSAP policy statement on chemical inactivation of whole tissue or homogenized tissue

    The Federal Select Agent Program (FSAP) has issued a new policy regarding the chemical inactivation of whole tissue or homogenized tissue.

    In meeting the in-house validation/verification of inactivation by chemical inactivation of whole tissue or homogenized tissue, it is FSAP policy to allow entities to select one tissue type (either (1) the tissue that is expected to have the highest concentration of the specific agent to be inactivated or (2) determine agent concentration for the agent to be inactivated in a tissue before performing inactivation to use as the maximum limit for that agent) to serve as a surrogate for other tissues, including those in other animal models, so long as all standardized conditions are held constant such as the agent used, tissue size, and ratio of tissue to volume of inactivating chemical. A safety margin must be incorporated into the final chemical inactivation procedure to ensure the effective inactivation of the agent.

    Please see the full policy for additional information. The policy is posted here.

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


  • 2/08/18 - AgSAS policy statement regarding biosafety level requirements for virulent Newcastle
    Disease virus

    The Agriculture Select Agent Services (AgSAS) has issued a policy statement regarding the biosafety level requirements for virulent Newcastle disease virus.

    It is the policy of the Agriculture Select Agent Services (AgSAS) that:

    • Any individual or entity conducting work with any non-exempted virulent Newcastle disease virus isolate must do so within an animal biosafety or biosafety level 3 (ABSL- or BSL-3) space, consistent with the Biosafety in Microbiological and Biomedical Laboratories recommendation for such agents.
    • An individual or entity may request a variance to this policy by submitting a request, accompanied by a risk assessment providing details of enhancements and preventative measures to mitigate work in a lower containment space, by email to AgSAS@aphis.usda.gov.

    The full policy is posted here.

    If you have any questions regarding this email, please contact AgSAS at 301-851-3300 option 3 (voice only) or agsas@aphis.usda.gov.


  • 2/02/18 - AgSAS policy statement regarding live bird lethality testing requirements for
    pathogenicity testing of reverse genetically derived viruses for avian influenza virus

    The Agriculture Select Agent Services (AgSAS) has issued a final policy statement regarding the removal of live bird lethality testing requirements for determining the pathogenicity characteristics of reverse genetically derived viruses, for avian influenza viruses.

    It is the policy of the Agriculture Select Agent Services (AgSAS) that:

    • We will accept reassortant virus exclusion requests, absent of live bird lethality testing data, for avian influenza constructs that meet specific criteria related to replication, cleavage site alteration, and gene insert characterization.
    • In lieu of the bird lethality testing, AgSAS will require all reverse genetically derived H5/H7 viruses with PR8 or similar human vaccine strain backbone to confirm genetic sequencing and demonstrate LPAI virus functionality through alternate requirements specified in the policy statement.

    The full policy is posted here.

    If you have any questions regarding this email, please contact AgSAS at 301-851-3300 option 3 (voice only) or agsas@aphis.usda.gov.


  • 2/05/18 - Update on Access Approval Expirations

    As the Federal Select Agent Program (FSAP) previously shared with the regulated community, the eFSAP system contains a feature to help Responsible Officials (ROs) monitor pending expiration of employee approval for access to select agents and toxins.  In the Section 4 screen of the APHIS/CDC Form 1 found in eFSAP, the system highlights when an individual’s access approval is about to expire.  To prevent an individual’s access to select agents and toxins from terminating unnecessarily, we recommend that any individual identified as needing a renewal (90 days from termination or “orange” designation) should immediately initiate the process for renewal by submitting a new form FD-961 to the Criminal Justice Information Services Division (CJIS).

    Should an individual’s access approval expiration date pass without having completed a renewal, FSAP will remove those individuals from the entity’s registration and their access to select agents and toxins will be revoked.  If this happens, the RO is responsible for requesting that the individual be added back to the registration.

    As previously shared, FSAP will no longer send out “expiring access approval” notification letters.  It is the responsibility of each RO to monitor the status of their entity’s individuals’ access approvals and ensure that the appropriate renewal paperwork is submitted in a timely manner.

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


  • 2/02/18 - Change in Leadership at the Agriculture Select Agent Services (AgSAS)

    The Federal Select Agent Program would like to announce a change in leadership at the Agriculture Select Agent Services (AgSAS). On Monday, February 5, 2018, Dr. Freeda Isaac will leave AgSAS to become the Executive Director of National Import Export Services, under Animal and Plant Health Inspection Service’s (APHIS) Veterinary Services.

    Also effective on February 5, Dr. Keith Wiggins will become AgSAS’ Acting National Director. Before this assignment, Dr. Wiggins served as the Associate National Director of AgSAS. Dr. Wiggins began his APHIS career in 2005. Throughout the last 13 years has served in leadership roles from enforcing regulations for the import of animal products and by-products to mitigate the introduction of foreign animal diseases, to ensuring that agricultural viruses, bacteria, and toxins are safeguarded to prevent agro-bioterrorism and public health threats. Prior to joining APHIS, Dr. Wiggins practiced veterinary medicine in North Carolina, was a Regional Veterinarian for Hill’s Pet Nutrition, and taught college courses at Livingstone College, the College of Southern Maryland, and Prince George’s Community College. Dr. Wiggins holds a Doctorate in Veterinary Medicine from Tuskegee University. He served as a Missile Launch Officer in the United States Air Force, and is currently serving as a Chief Public Health Officer in the New Jersey Air National Guard.

    If you have any questions regarding this email, please contact AgSAS at 301-851-3300 option 3 (voice only) or agsas@aphis.usda.gov.


  • 1/25/18 - Marijuana Use by Individuals Approved for Access to Select Agents and Toxins

    It is has come to the attention of the Federal Select Agent Program (FSAP) that there may be some confusion within the regulated community concerning the use of marijuana by individuals approved for access to select agents and toxins in states where some use of marijuana is now legal as a matter of state law.    

    Responsible Officials need to clearly understand and communicate to persons within their entity, that any person who uses marijuana or holds a medical marijuana card, regardless of state law, is considered by the Federal Government to be an unlawful user of a controlled substance and is therefore a “restricted person” and prohibited by federal law from having access to select agents and toxins.

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

  • 1/17/18 - Exclusion of Burkholderia pseudomallei and Burkholderia malleistrains

    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 several attenuated strains of Burkholderia pseudomallei and Burkholderia mallei are not subject to the requirements of the select agent regulations.  These exclusions include:

    • Nine Burkholderia pseudomallei Δasd strains
    • Four Burkholderia mallei Δasd strains

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

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


  • 1/12/18 - Use of eFSAP for Immediate Notification Submissions (APHIS/CDC Forms 3 and 4A)

    The Federal Select Agent Program (FSAP) would like to ensure eFSAP users are aware that they can now submit immediate notifications for APHIS/CDC Form 3 and APHIS/CDC Form 4A directly to FSAP via the system.

    Attached to this message are tutorials with screenshots detailing these features.  (Available here).  

    eFSAP users may access the system at https://fsap.cdc.gov.  If you experience errors or have questions related to the eFSAP system in general or with SAMS access to the system (e.g.,log in problems, system outage) please continue to contact the eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.   You may also wish to visit our online eFSAP Resource Center

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


  • 1/09/18 - Additional eFSAP Training Videos Now Available

    The Federal Select Agent Program (FSAP) has recently posted several additional online videos to assist users with completing tasks in the electronic Federal Select Agent Program portal, eFSAP.

    The new videos, available here, will help users complete functions associated with APHIS/CDC Forms 1 – 4 and include the following:

    • How to change an entity’s name, abstract, or type (Form 1 Section 1 amendments)
    • How to change an entity’s physical or additional address (Form 1 Section 1 amendments)
    • How to add personnel to an entity’s registration (Form 1 Section 4 amendments)
    • How to submit an APHIS/CDC Form 2 Section 1
    • How to submit an APHIS/CDC Form 2 Section 2
    • How to submit an APHIS/CDC Form 2 Section 3
    • How to submit an APHIS/CDC Form 3
    • How to submit an APHIS/CDC Form 4a Sections a and b
    • How to submit an APHIS/CDC Form 4a Sections c and d
    • How to submit an APHIS/CDC Form 4b

    Additional resources will continue to be posted to this page as they become available.

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