Select Agent (SA) Grams

2019 SA Grams

6/3/19 - New FSAP Inspection Checklist App

The Federal Select Agent Program (FSAP) has developed a new mobile application in order to assist laboratory managers and biosafety personnel in performing internal laboratory inspections. The Federal Select Agent Program Laboratory Examination Tool, or FSAP-LET, contains checklists that are based on federal regulations and biosafety standards used by FSAP inspectors. The checklists cover a variety of areas such as biosafety, security, training, and incident response.

The app is available to download for the following devices:

Please note that, while the tool is intended to assist laboratories in meeting federal regulations and biosafety standards, it is not all-inclusive. The responsibility to fully adhere to applicable federal regulations remains with the entity using the tool.

For more information, please visit: https://www.selectagents.gov/checklistapp.html.





  • 5/20/19 - Changes to the Agriculture Select Agent Services Director Position

    As previously announced, the Agriculture Select Agent Services (AgSAS) National Director position became vacant on April 1, 2019. Leaders from the Veterinary Services program will serve in the position – re-titled AgSAS Director (removing “National”) – on an acting basis until it is permanently filled.

    The Federal Select Agent Program (FSAP) wishes to thank Dr. Narda Huyke, whose detail ended on May 18, 2019, for her service as AgSAS Director over the past months.

    Effective May 19, 2019, Dr. Lisa Dixon has assumed the duties of the AgSAS Director through August 17, 2019.

    Dr. Dixon graduated from Tuskegee University School of Veterinary Medicine, and also holds a Master’s degree in Public Health from Walden University. After completing an equine internal medicine internship at Oklahoma State University, followed by many years of private practice, she entered the federal workforce in 2008.

    Dr. Dixon served as a Supervisory Public Health Veterinarian and Enforcement Investigation and Analysis Officer with the Food Safety and Inspection Service, prior to joining the Animal and Plant Health Inspection Service (APHIS) as a Veterinary Medical Officer in 2013.

    Since 2017, Dr. Dixon has served as the Director of Animal Product Imports, within Veterinary Services. As such, she oversees the program responsible for permitting, negotiation, and policymaking for animal product imports. She is also integrally involved in the USDA Approved Establishment Program for Restricted Products, the Cross Functional Working Group for Regulated Garbage, and the Veterinary Services’ National Civil Rights and Diversity Advisory Council.

    FSAP will continue to inform the regulated community of further changes to the Acting AgSAS Directors via the FSAP website and by SA Gram.

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


  • 5/17/19 - Materials available from recent FSAP webinar on entity annual internal inspections

    The Federal Select Agent Program (FSAP) has posted to its website materials from the April 18, 2019 webinar.  The purpose of the webinar was to discuss and answer questions regarding the recently revised policy statement on entity annual internal inspections.  The materials, including the webinar presentation and a video recording, are available at https://www.selectagents.gov/training.html.

    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.


  • 5/17/19 - eFSAP training on update just released

    The Federal Select Agent Program (FSAP) recently announced the deployment of a major system update to the electronic Federal Select Agent Program (eFSAP) information system. Entities are encouraged to sign up for our upcoming webinars covering: APHIS/CDC Forms 2, 3, and 4 printing; APHIS/CDC Form 1 Section 4 and Section 7B data export; notification table enhancements; and file archiving.

    Sessions will be held at the following dates/time:

    • May 20: 10-11 am ET
    • May 22: 1-2 pm ET
    • May 30: 3-4 pm ET

    To register for a session, please visit the 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.


  • 5/16/19 - Updated regulatory interpretation regarding requirement for inactivation certificates and intra-entity transfers

    In 2017, the Federal Select Agent Program (FSAP) issued a regulatory interpretation regarding the requirement for inactivation certificates and intra-entity transfers.  FSAP has updated that regulatory interpretation to clarify that a certificate must be generated every time material is inactivated, regardless of whether the material is transferred or not.  The updated regulatory interpretation reads as follows:

    A copy of an inactivation certificate must accompany the inactivated material when the inactivated material is transferred externally (from your entity to another entity). It is recommended that an inactivation certificate also accompany the transfer of inactivated material internally (from one PI to another PI at the same registered entity).  Additionally, regardless of whether a transfer is made, an entity remains responsible for the record keeping requirements found in section 17(a)(8) of the select agents and toxins regulations.  An original certificate must be generated for every sample inactivated regardless of future transfer.

    FSAP recommends that entities maintain the certification of inactivation as long as the material is in their possession.

    The updated regulatory interpretation was posted online today (May 16, 2019) and replaces the previous response dated June 16, 2017.  It is now available at https://www.selectagents.gov/reg-int_certificates.html.

    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.

  • 5/16/19 - eFSAP system update just released: 1) Forms 2, 3, and 4 printing, 2) Form 1 Section 4 and Section 7B data export, 3) Notification table enhancements, 4) File archiving

    The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another major system update to the electronic Federal Select Agent Program (eFSAP) Information System.  Based on feedback from the regulated community, we believe these new features will provide a better user experience. 

    Beginning May 16, 2019, authorized SAMS account holders at all registered entities will notice the following significant updates:

    • APHIS/CDC Forms 2, 3, and 4 printing
      Responsible Officials (ROs), Alternate Responsible Officials (AROs), and entity “read-only” users now have the ability to print all sections of Forms 2, 3, and 4.

    • APHIS/CDC Form 1 Section 4 and Section 7B data export
      ROs and AROs now have the ability to export Section 4 data.  In addition, read-only users as well as ROs and AROs have the ability to export Section 7B data.  The data is exported into a .csv file that is compatible with common spreadsheet applications.

    • Notification table enhancements
      Numerous enhancements have been made to the notification tables found at the top of the entity home page and inspection details page.  Entities now get the following notifications:

      • When a person is approved by FSAP for access to select agents and toxins
      • When a person’s FSAP approval for access to select agents and toxins is 45 and 90 days from approval expiration
      • When a person’s FSAP approval for access to select agents and toxin has expired

      In addition, ROs, AROs, and read-only users now have the ability to flag notifications for follow up and to archive notifications.

    • File archiving
      ROs and AROs now have the ability to archive previously uploaded files.  The archiving feature is available system-wide from the grid tables at the bottom of the entity landing page, inspection details page, and at the bottom of each section of Forms 1-4.

    In addition to the major features listed above, eFSAP users will also notice the following minor enhancements:

    • APHIS/CDC Form 1 Section 7A/C now includes a keyword search feature that filters information down to the requested search term.
    • The Inspection Module has been updated to allow additional response time when FSAP requests subsequent information related to an inspection finding.
    • The APHIS/CDC Form 1 interface has been optimized, making all sections landscape-oriented.

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

    If you experience errors, have questions, or have challenges 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.



  • 4/12/19 - Reminder regarding entity verification requirements for FSAP inspectors performing site visits of registered entities

    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 their performing his/her duties.  Each individual also maintains a copy of his/her immunization records and his/her respirator fit testing card.  The inspectors are not allowed to participate in any 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 the Federal Select Agent Program at 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.


  • 4/02/19 - Agriculture Select Agent Services (AgSAS) National Director Position

    The Federal Select Agent Program (FSAP) congratulates Dr. Adis Dijab, previous National Director of the Agriculture Select Agent Services (AgSAS), on his recent appointment as Executive Director of Field Operations in Veterinary Services. As pleased as we are for Dr. Dijab, this means that the AgSAS National Director position became vacant effective April 1, 2019. Leaders from the Veterinary Services program will serve as National Director on an acting basis until the position is filled permanently.

    Most immediately, Dr. Narda Huyke will provide coverage as acting AgSAS National Director through May 18, 2019. Dr. Huyke received her Bachelor of Science and Doctor of Veterinary Medicine degrees from the University of Illinois. She worked in veterinary pathology, laboratory animal medicine, and research compliance before joining APHIS in 2006. Since then, she has served as a Veterinary Medical Officer in the Diagnostic Virology Laboratory of the National Veterinary Services Laboratories and the Professional Development Services staffs before joining AgSAS in 2016. Most recently, Dr. Huyke served as the acting Technical Unit Director for AgSAS.

    FSAP will continue to inform the regulated community of changes to the Acting National Directors via the FSAP website and by SA Gram. Coverage of this position is expected to rotate as outlined below:

    April 1 – May 18, 2019
    Dr. Narda Huyke
    Narda.Huyke@usda.gov
    301-851-3376

    May 19 – August 17, 2019
    Dr. Lisa Dixon
    Lisa.M.Dixon@usda.gov
    301-851-3373

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

  • 3/27/19 - New FSAP Compliance Infographics Now Available Online

    The Federal Select Agent Program (FSAP) regulates laboratories working with select agents and toxins and helps to ensure that lifesaving research conducted with these potentially dangerous materials is done as safely and securely as possible.  While there is always some risk in working with select agents and toxins, our goal is to get as close to zero risk as possible.  Unfortunately, incidents do occur, and sometimes serious deficiencies in biosafety or security measures are identified at the laboratories that work with these materials.

    The good news is that the vast majority of laboratories are doing well in following the select agent regulations. However, when issues do arise, systems are in place to deal with those situations.  Importantly, FSAP can take action in order to protect public, animal, and plant health, using a number of available options to address any potential risks and bring the entity back into compliance with the regulations.

    The Federal Select Agent Program has developed a new series of infographics in order to describe these processes in more detail.  Posted to the FSAP website (available at https://www.selectagents.gov/infographics-compliance.html), you will find new infographics covering the following topics:

    • How the Federal Select Agent Program Addresses Serious Biosafety or Security Concerns
    • Theft or Loss of a Select Agent or Toxin
    • Release of a Select Agent or Toxin
    • About the Federal Select Agent Program

    We hope that these materials are useful references for you, and that they help to provide additional insight into these processes – for both the regulated community as well as anyone else who is interested in learning more about compliance with the select agent regulations.  Please feel free to share them with others in your organization who may be interested as well.

    If you have any questions, 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.


  • 3/22/19 - Revised policy statement regarding the entity annual internal inspections

    The Federal Select Agent Program (FSAP) has issued a revised policy statement regarding the entity annual internal inspection required by section 9(a)(6) of the select agent regulations. The revised policy clarifies that the annual inspection must include the biosafety, security, incident response and training sections of the regulations.

    The revised policy replaces the previous FSAP policy statement on the subject (issued August 9, 2018).  All elements of the revised policy take effect immediately. 

    The policy is available online at https://www.selectagents.gov/policystatement_annualinspection.html.  

    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.


  • 2/26/19 - Updated Responsible Official Guidance Document Now Available

    The Federal Select Agent Program (FSAP) has finalized updates to its guidance document for Responsible Officials (ROs), the Responsible Official Resource Manual. This document includes helpful information for ROs on fundamental responsibilities of the role, authority, delegating, compliance, reporting, records, and internal inspections. The new guidance is available at https://www.selectagents.gov/rorm-changes.html.

    A draft version of this guidance document was previously shared with the regulated community for review and input prior to being finalized. Based on comments from the regulated community, the final document includes a security risk assessment section and a table that outlines the notification process utilizing the select agent program forms.

    In addition, changes from the previous published version of the document include removal of the section titled “Three Year Cycle of RO Tasks” and adds references to FSAP’s recently issued policy and guidance on entity annual internal inspections.

    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@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

  • 2/12/19 - eFSAP System Training on APHIS/CDC Form 1 Amendments and Inspection Module version 1.1

    The Federal Select Agent Program (FSAP) recently announced the deployment of a major system update to the electronic Federal Select Agent Program (eFSAP) information system. Entities are encouraged to sign up for our upcoming webinars covering the new APHIS/CDC Form 1 amendment types and the eFSAP inspection module. To register for these webinars, please visit the Training Registration 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 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.

  • 2/08/19 - Revised FAQ Posted on FSAP Website

    The Federal Select Agent Program (FSAP) has posted a revised Frequently Asked Question (FAQ) on its website in order to address the applicability of the exclusion provisions found in section 3d(4) and section 4d(4) (a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure) to a clinical or diagnostic laboratory identifying a select agent in a specimen presented for diagnosis or verification or proficiency testing as outlined in sections 5 and 6 of the select agent regulations.

    The following revised FAQ can be found at https://www.selectagents.gov/faq-inactivation.html:

    If a laboratory receives a diagnostic sample and extracts nucleic acids for polymerase chain reaction (PCR), do the inactivation requirements found in section 3d(4) and section 4d(4) apply to the extracted nucleic acids?

    The inactivation requirements found in section 3d(4) and section 4d(4) do not apply if the purpose of the diagnostic work is not for future use of a known select agent, and the nucleic acids extracted do not meet the definition of regulated nucleic acids:

    1. Nucleic acids that can produce infectious forms of any of the select agent viruses or
    2. Recombinant and/or synthetic nucleic acids that encode for the toxic form(s) of any of the select toxins if the nucleic acids: (i) Can be expressed in vivo or in vitro, or (ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro.

    However, if the diagnostic work identifies a select agent, then the original clinical or diagnostic sample would be considered a select agent and must be transferred or destroyed on-site (by a recognized sterilization or inactivation process) within seven calendar days after delivery of patient care by health care professionals has concluded, or put into long term storage inventory (if registered with FSAP).
    It is strongly recommended, but not required, that a clinical or diagnostic laboratory validates their inactivation procedures in-house to reduce the risk of failure of an inactivation procedure. The failure of a clinical or diagnostic laboratory to destroy a select agent or toxin using an inactivation procedure could result in civil and/or criminal penalties.

  • 1/31/19 - eFSAP system update just released: 1) All APHIS/CDC Form 1 Amendments Types now Available electronically in eFSAP, 2) release of Inspection Module version 1.1 for use on all FSAP inspections

    The Federal Select Agent Program (FSAP) is pleased to announce the deployment of a major system update to the electronic Federal Select Agent Program (eFSAP) information system.  With this release, APHIS/CDC Form 1 now joins APHIS/CDC Forms 2-4 in providing registered entities the ability to complete all sections of the form 100% electronically in eFSAP.  We have also made enhancements to the eFSAP inspection module based on feedback from FSAP and entity users during the late 2018 pilot period.

    Beginning January 31, 2019, authorized SAMS account holders at all registered entities will notice the following updates:

    Additional APHIS/CDC Form 1 Amendment Types

    Responsible Officials (ROs) and Alternate Responsible Officials (AROs) have the ability to perform the following Form 1 amendments directly in eFSAP:

    • Section 3: Add, Remove, or Reactive select agents and toxins
    • Section 4: Request Change of Responsible Official
    • Section 6: Add, Remove, or Modify Buildings
    • Section 6: Add, Remove, or Modify Laboratory Rooms and Suites
    • Section 7: Add, Remove, or Modify work objectives

    In preparation for these new amendment types, in November 2018 FSAP staff began migrating entities’ Form 1 Sections 7a and 7c data to a new format.  Entities were asked to verify that the data was migrated correctly by the end of December 2018.  FSAP would like to thank the majority of entities who completed this verification and encourage those few entities that have not yet verified their data to do so as soon as possible. To make use of the new electronic amendment types listed above, verification of the new Form 1 section 7a and 7c is required.

    Inspection Module version 1.1

    In late August 2018, FSAP released the first version of a new, interactive, electronic inspection module in eFSAP.  From September – December, 2018, FSAP employed limited use of the inspection module during an initial pilot phase.  Based on feedback from FSAP inspectors and entities participating in the pilot, additional features and refinements have been implemented.  The following is the full list of features entities will now experience:

    • Entities have awareness regarding the inspection team and inspection focus as soon as FSAP staffs the inspection and generates checklists for the inspection.
    • Entities have the ability to respond to inspection findings on an individual basis as time and resources permit.
    • The inspection resolution page (inspection report) contains toggle filters allowing quick navigation to inspection findings based on their status (open vs. closed) and type (departure, general concern, request for information, etc.)
    • Directly through the inspection module, FSAP has the ability to close inspection findings or ask for additional information. 
    • Entities have the ability to print their inspection findings with or without all correspondence with FSAP regarding the inspection findings.
    • eFSAP generates automated entity notifications regarding the following inspection-related events: when inspections are scheduled, as inspection findings are released for entity review, any time there is correspondence to or from FSAP regarding resolution of inspection findings, and upon closeout of each finding.

    In addition to the major features listed above, eFSAP users will also notice the following minor enhancements:

    • Users will be notified when trying to upload a file with a title containing special characters incompatible with eFSAP (e.g., ~, #, &, ?, +)
    • The Help and Support Section at the bottom of every page of eFSAP now contains a direct link to the eFSAP resource center.
    • Entities are able to request a change of their lead regulatory agency (HHS vs. USDA) in a manner similar to how they currently request a renewal of their registration

    For more information, please review the tutorials with screenshots of the new features attached to this message.  Entities are also encouraged to sign up for our upcoming webinars covering the new APHIS/CDC Form 1 amendment types and the eFSAP inspection module. To register for these webinars, please visit the Training Registration 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.


  • 1/18/19 - Federal Bureau of Investigation’s Criminal Justice Information Services Division and Processing Security Risk Assessments

    This information concerns those individuals whose Federal Select Agent Program (FSAP) approval to access select agents and toxins had an expiration date falling within or shortly after the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS) partial government shutdown period.

    The furloughed CJIS employees who process security risk assessments have resumed normal operations.  During the 20 day shutdown for these employees, CJIS continued to receive FD-961 Forms and fingerprint cards for security risk assessments.  To address the renewal of FSAP access approvals associated with the backlog in the processing of security risk assessments created by the 20 day shutdown period, FSAP has determined that all personnel with current access approval whose FD-961 has been received by CJIS will remain approved for a period of 60 days (unless that person is identified by CJIS as a “restricted person”) to allow CJIS sufficient time to process these renewal security risk assessments and FSAP to process access approvals.

    If you have any questions, please contact sra.cdc@leo.gov.

  • 1/09/19 - Packages sent to AgSAS

    Due to the absence of either an FY 2019 appropriation or Continuing Resolution for the Department of Agriculture, the Agriculture Select Agent Services is unable to accept any packages mailed to:

    Animal and Plant Health Inspection Service
    Agriculture Select Agent Services
    4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07
    Riverdale, MD 20737

    Information can be submitted through fax: 301-734-3652, email: AgSAS@usda.gov, or submission through eFSAP. 

  • 1/02/19 - Processing Security Risk Assessments due to Government Shutdown for Criminal Justice Information Services Division

    Due to the absence of either an FY 2019 appropriation or Continuing Resolution for the Department of Justice that affected the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS), the Federal Select Agent Program (FSAP) has determined that all personnel whose access approval expires during the shutdown will remain approved. After the resolution of the shutdown, FSAP will notify entities of the revised access approval expiration date through eFSAP.

    Entities should continue to submit renewal documents to CJIS.  Please email documentation to fd961@leo.gov and sra.cdc@leo.gov. For new applications, please mail document to CJIS at:

    Bioterrorism Security Risk Assessment Group E-3
    CJIS Division
    1000 Custer Hollow Road
    Clarksburg, WV 26306-0002

    Do not mail or email documents directly to FSAP. CJIS will start processing security risk assessments after the resolution of the shutdown.

    It should be noted that the Division of Select Agents and Toxins and Agriculture Select Agent Services are not be affected by the government shutdown.

    If you have any questions, please contact sra.cdc@leo.gov.