Select Agent (SA) Grams

2019 SA Grams

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.


  • 1/22/19 - Save-the-Date: 2019 Responsible Official Workshop to be held July 23-25

    On July 23-25, 2019, the Federal Select Agent Program (FSAP) will host a multi-day in-person workshop for Responsible Officials at the USDA Headquarters Building, Jefferson Auditorium, in Washington DC (1400 Independence Ave. SW, Washington, DC, 20250). The Headquarters building is located on the National Mall, near the Smithsonian Metro station. This year’s workshop will cover topics such as updates to the program, and improved functionality of the eFSAP program, among other items.  The format will include presentations and small group discussion sessions, as well as provide an opportunity to network with colleagues.

    We would respectfully request your input on additional items that are not covered by this list, so we can provide you with the most up to date and focused topics possible. Please send suggestions for agenda topics to lrsat@cdc.gov or agsas@aphis.usda.gov.

    The workshop is open only to Responsible Officials and Alternate Responsible Officials and limited to 200 participants. Information about registration and a detailed agenda will be provided in the coming weeks. You will find some information regarding the venue and some lodging information attached.

  • 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.