Select Agent (SA) Grams

2017 SA Grams


9/14/17 - Final Severity Spectrum of Inspection Departures and Enforcement Options

The Federal Select Agent Program (FSAP) has finalized its severity spectrum of inspection departures and enforcement options; this spreadsheet outlines categories of inspection regulatory departures grouped according to the level of severity, as well as related enforcement options that may be applied. The document, posted online and now available here, aims to provide awareness of how FSAP considers the severity of inspection findings and provide visibility to the application of enforcement options to these findings. Example violations are grouped into a three-tier risk scoring system in the categories of low, moderate, and serious severity levels.

Departures may include findings of low risk as well as findings that may lead to an immediate stoppage of some or all activities. Please note that this is not meant to be an all-inclusive list of possible departures, but is meant to convey, at a large scale, how FSAP views risk.

As you may recall, the draft document was previously shared with the regulated community for review and input prior to being finalized. While the final document incorporates feedback received to date, it does not reflect any major changes from the draft version.

The document was developed as a part of FSAP’s efforts to increase the quality and consistency of inspections and addresses a number of program improvement recommendations received as part of the CDC 90-day Review and the Fast Track Action Committee on the Select Agent Regulations. Completion of this item reflects another important milestone for the program in meeting those recommendations.

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.



  • 8/21/17 - FSAP policy statement regarding the approval of a person to be a Responsible Official at only one entity


    The Federal Select Agent Program (FSAP) has issued a final policy statement regarding the approval of a person to be a Responsible Official (RO) at only one entity.

    It is the policy of the FSAP that:

    • An individual will not be approved by the FSAP to be an RO at more than one entity.
    • An individual who has been approved to be an RO will not be approved by the FSAP to be an Alternate Responsible Official (ARO) at another registered entity.
    • An individual who has been approved by the FSAP to be an ARO at one entity can be approved by the FSAP to be an ARO at another registered entity as long as when they serve as RO, they can meet the provisions outlined in Section 9 of the select agent regulations.

    This policy is posted here.

    A draft of this policy was previously shared with the regulated community for feedback. As a result of feedback received during this period, revisions were made to address the ability for a single individual to be approved as an ARO at multiple entities.

    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.

    8/18/17 - FSAP policy statement regarding the non-exclusion of study-related activities involving naturally infected animals

    The Federal Select Agent Program (FSAP) has issued a policy statement regarding the non-exclusion of study-related activities involving naturally infected animals from the requirements of the select agent regulations.

    Per the select agent regulations, possession of an animal which is naturally infected with a select agent, either within its natural environment or having been transported to an artificially established environment, meets the regulatory exclusion criteria.  [See 42 C.F.R. §§73.3(d)(1), §73.4(d)(1); 9 C.F.R. §§121.3(d)(1), 121.4(d)(1)]

    However, it is the policy of the Federal Select Agent Program that

    • removal of an animal which is naturally infected with a select agent from its natural environment to an artificially established environment for the purpose of the intentional exposure or introduction of a select agent to a naïve or experimental animal, or
    • the introduction of a naïve animal to a natural environment where there is an animal which is naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to the naïve or experimental animal

    does not meet the regulatory exclusion criteria. Accordingly, any work with an animal naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to any naïve or experimental animal may only be conducted after FSAP approval for an entity or individual registered for possession and use of such select agent.

    If an animal is confirmed to be naturally infected with a select agent there may be additional transfer and/or transport restrictions based upon specific USDA and state requirements.

    This policy is posted here.

    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.


  • 8/18/17 - FSAP policy statement regarding the non-exclusion of study-related activities involving naturally infected animals


    The Federal Select Agent Program (FSAP) has issued a final policy statement regarding the approval of a person to be a Responsible Official (RO) at only one entity.

    It is the policy of the FSAP that:

    • An individual will not be approved by the FSAP to be an RO at more than one entity.
    • An individual who has been approved to be an RO will not be approved by the FSAP to be an Alternate Responsible Official (ARO) at another registered entity.
    • An individual who has been approved by the FSAP to be an ARO at one entity can be approved by the FSAP to be an ARO at another registered entity as long as when they serve as RO, they can meet the provisions outlined in Section 9 of the select agent regulations.

    This policy is posted here.

    A draft of this policy was previously shared with the regulated community for feedback. As a result of feedback received during this period, revisions were made to address the ability for a single individual to be approved as an ARO at multiple entities.

    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.

    8/18/17 - FSAP policy statement regarding the non-exclusion of study-related activities involving naturally infected animals

    The Federal Select Agent Program (FSAP) has issued a policy statement regarding the non-exclusion of study-related activities involving naturally infected animals from the requirements of the select agent regulations.

    Per the select agent regulations, possession of an animal which is naturally infected with a select agent, either within its natural environment or having been transported to an artificially established environment, meets the regulatory exclusion criteria.  [See 42 C.F.R. §§73.3(d)(1), §73.4(d)(1); 9 C.F.R. §§121.3(d)(1), 121.4(d)(1)]

    However, it is the policy of the Federal Select Agent Program that

    • removal of an animal which is naturally infected with a select agent from its natural environment to an artificially established environment for the purpose of the intentional exposure or introduction of a select agent to a naïve or experimental animal, or
    • the introduction of a naïve animal to a natural environment where there is an animal which is naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to the naïve or experimental animal

    does not meet the regulatory exclusion criteria. Accordingly, any work with an animal naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to any naïve or experimental animal may only be conducted after FSAP approval for an entity or individual registered for possession and use of such select agent.

    If an animal is confirmed to be naturally infected with a select agent there may be additional transfer and/or transport restrictions based upon specific USDA and state requirements.

    This policy is posted here.

    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.


  • 8/17/17 - Information Requirement for HHS/USDA Office of Inspector General Hotlines

    The Federal Select Agent Program (FSAP) wishes to provide the following information to the regulated community to assist with the implementation of the specific requirements related to information provision and documentation as outlined in Section 9(a)(7) and Section 15(e) of the select agent regulations.

    Specifically:

    • Section 9(a)(7) – The RO must ensure that as of March 21, 2017, all individuals listed on the entity’s registration have been provided the contact information for the HHS Office of Inspector General Hotline and the USDA Office of Inspector General Hotline so that they may anonymously report any biosafety or security concerns related to select agents and toxins); and
    • Section 15(e) – The RO document that individuals have been provided the above referenced information.

    We note that the regulatory requirements found in sections 9(a)(7) and 15(e) of the select agent regulations are not an “annual training” requirement; but rather, an “ongoing” requirement.

    We also note that a registered entity has a great deal of flexibility in how it meets these requirements. It may post the information where everyone associated with the registered entity has ready access to the information. It may individually inform each person associated with the registered entity; but if it takes that approach, the entity must ensure that each new person also receives the information. As for documentation, a registered entity may either do so by posting the information or creating some type of record describing the method the entity uses to ensure that individuals are provided the contact 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.

  • 8/14/17 - Revised policy statement regarding the inactivation of Bacillus anthracis and Bacillus cereus Biovar anthracis

    The Federal Select Agent Program (FSAP) has issued a revised policy statement regarding the inactivation of Bacillus anthracis, including Bacillus anthracis Pasteur strain and Bacillus cereus Biovar anthracis. Key changes are as follows:

    1. Clarifies that the policy includes exclusion for certain inactivated material
    2. Removes the kill curve and neutralization curve requirements
    3. Clarifies other language throughout (non-substantive changes)

    The revised policy replaces the previous FSAP policy statement on the subject (issued April 19, 2017). All elements of the revised policy take effect immediately.

    The policy is available here.

    The corresponding frequently asked questions have also been updated, and are available here.

  • 8/11/17 - Reminder regarding the requirement for a “validated inactivation procedure”

    The Federal Select Agent Program (FSAP) wishes to remind the regulated community that the requirement to validate inactivation procedures applies to formalin fixation of tissues. Entities must validate the formalin fixation procedure by performing a viability test in-house.

    Please refer to the FSAP policy dated April 6, 2017 for more information on in-house validation. The policy is available at here. For your reference, the latest FSAP guidance document on inactivation is also available at 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 DSATScienceoffice@cdc.gov for CDC/DSAT entities.

  • 8/10/17 - Revised APHIS/CDC Form 3 (Report of Theft, Loss, or Release of Select Agents and Toxins) Available for Public Comment

    The Federal Select Agent Program (FSAP) wishes to share the following information for your awareness.

    The Centers for Disease Control and Prevention recently published a notice in the Federal Register on August 3, 2017 seeking public comment on the revised APHIS/CDC Form 3, which is used by entities to report theft, loss, or release of a select agent or toxin. The Federal Select Agent Program (FSAP) revised the APHIS/CDC Form 3 to further clarify what needs to be reported as a "release" and "loss" and included additional fields to assist with categorizing the type of release (e.g., spill within secondary containment, release due to failure of inactivation, occupational exposure, possible breach of facility containment, etc.), type of exposure, and the understanding of safety and security risk levels relative to human illness.

    Efforts to update the APHIS/CDC Form 3 follow recent recommendations for program improvements, and you may recall that earlier versions of this revised document have been previously shared by FSAP for feedback, as well as updated accordingly. The notice also acknowledges that FSAP has updated its series of guidance documents.

    To request additional information on the revised APHIS/CDC Form 3 or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or suggestions on the APHIS/CDC Form 3 should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments must be received on or before September 2, 2017.

  • 7/26/17 - Update on DSAT Inspection Report Card Pilot

    As a part of the Federal Select Agent Program (FSAP)’s efforts to increase the quality and consistency of inspections, as well as the content and clarity of inspection reports, in October 2016 the Centers for Disease Control and Prevention (CDC)’s Division of Select Agent and Toxins (DSAT) began a pilot project for issuing inspection summaries (“report cards”) to DSAT-registered entities. These report cards were issued along with the inspection report to summarize the entity’s regulatory departures following an inspection and show how its performance compares relative to other entities.

    After a pilot period, during which approximately 50 report cards were issued, DSAT has concluded the pilot and will not be issuing any further inspection report cards in the immediate future. During this intermission, DSAT will work to adjust the model used to develop these report cards to better incorporate and reflect recent changes to the regulations following the March implementation of the amended select agent regulations. The program will also make any additional needed adjustments, including changes that may need to be made as a result of implementation of the new FSAP IT system (eFSAP).

    Following this evaluation period, DSAT intends to resume issuing inspection report cards as a routine part of inspection reports. We will continue to keep you updated.

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

  • 7/24/17 - eFSAP/SAMS Updates and FAQs

    The Federal Select Agent Program (FSAP) recently conducted Secure Asset Management System (SAMS) enrollment training as part of the transition to FSAP’s new secure information system, eFSAP. SAMS enrollment is required to access the eFSAP information system. Many ROs and AROs have already received an automated invitation directly from SAMS to initiate enrollment; those who have not yet received an invitation will receive one shortly.

    We have received a number of questions about SAMS and the upcoming transition to eFSAP. Please see the information below and attached to assist you with enrollment questions and to provide additional information about eFSAP.

    A few of our most frequently asked questions are as follows:

    1. I have not yet received my SAMS invitation email. Was I overlooked?
      We are still issuing SAMS invitations for ROs and AROs who did not attend SAMS training. We have issued invitations to all SAMS training participants. If you attended any of our training sessions but did not yet receive your invitation, please look first in your spam folder, then contact us at DSATSAMSHELP@cdc.gov for another invitation to be sent to you.
    2. I have completed the SAMS enrollment process. When I click on the SAMS link, I get an error message. What am I doing wrong?
      You will receive an error message when you attempt to access the system until we activate the system for you. The initial step for you to gain access to eFSAP was enrollment in the SAMS system. We will notify you when you are able to view your data. We will also provide additional training for you on the eFSAP system and communicating with FSAP through the portal prior to our launch date.
    3. Our ROs and AROs share a corporate email box. Will this be an issue when we try to enroll in SAMS?
      Yes, each SAMS user must have a unique email address associated with your account. You may use the shared email address but it will only be associated with one specific person.
    4. I did not finish the enrollment process within 30 days as required. What do I need to do?
      Once you receive your invitation to enroll in SAMS, you must complete the enrollment process within 30 days. We will send you a reminder email prior to your invitation expiring, but after 30 days you must contact DSATSAMSHELP@cdc.gov for another invitation to be issued.

    Additional notes:

    • CDC-led entities are requested to use the DSATOps@cdc.gov mailbox for submission of all amendments and inspection-related documents.
    • APHIS-led entities should continue to use the agsas@aphis.usda.gov mailbox for submission of amendments and inspection-related documents.
    • Entities adding personnel to the entity registration must submit applications for security risk assessment (FD-961) directly to the Criminal Justice Information Service (CJIS) in order to expedite the amendment approval process. Applications should be submitted to:
      • FBI, CJIS, Bioterrorism
        1000 Custer Hollow Road, Module E-3
        Clarksburg, WV 26306-0147

    For guidance on how to complete the FD-961 form, please see the FBI website for additional information.

    We hope that this additional information is helpful to you. If you have further questions, 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.


  • 7/07/17 - 2017 Federal Select Agent Program Webcast Materials Now Available

    On April 28, 2017, the Federal Select Agent Program (FSAP) hosted a webcast to provide specific regulatory guidance and information on changes to the select agent regulations and on standards concerning biosafety, security, and incident response.  The Federal Register notice, workshop agenda, presentations, a recording of the webcast, and responses to questions received during the webcast are now posted on the FSAP website at https://www.selectagents.gov/training.html.    

    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.

  • 6/28/17 - Regulatory interpretation regarding waste disposal of select agents and toxins

    In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation regarding a select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.

    The questions and answers are as follows:

    • Does waste containing select agents or toxins decontaminated with commercial products (i.e. phenol, chloroform, phenol/chloroform, or Trizol™ or other similar commercial product waste) meet the exclusion provisions outlined in sections 3(d)(3) and 4 (d)(3) of the select agent regulations?

      Yes. For chemical decontamination, the chemical used must be appropriate for the select agent or toxin (Manufacturers normally test surrogates and not select agents and toxins. This would be acceptable.), and the chemical concentration and contact time should be defined in the procedure. The procedure should also address whether chemicals used for decontamination must be freshly prepared or can be stored, and note the shelf life if stored.

    • Is waste containing select agents or toxins decontaminated with commercial products (i.e. phenol, chloroform, phenol/chloroform, or Trizol™ or other similar commercial product waste) allowed to be moved to off-site for disposal by incineration as chemical waste, using an Environmental Protection Agency-registered hazardous waste contractor?

      Yes. The decontaminated waste would be considered excluded from the select agent regulations as outlined in sections 3(d)(3) and 4 (d)(3) of the select agent regulations

      You can find the full regulatory interpretation on this topic 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.


  • 6/26/17 - Regulatory interpretation regarding Gram stained slides containing select agents

    In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation regarding the select agent regulations as it relates to the preparation of a Gram stain slide using Burkholderia pseudomallei inside the biosafety cabinet (BSC) located in a registered room that is read on the microscope on the benchtop within the same room.

    The questions and answers are as follows:

    • Is the select agent considered outside of primary containment if viewed on the benchtop microscope?

      No. The select agent is not considered a release outside of the primary barriers of the biocontainment area because the agent is fixed onto the slide or washed off during Gram staining procedure.

    • If not wearing respiratory protection, is the staff member “potentially exposed” for just viewing the slide on the microscope outside of primary containment?

      No. A staff member viewing a Gram stain slide of B. pseudomallei on a microscope within the same registered room would not be considered exposed to the select agent.


    Please note that:

    • The regulatory interpretation applies to Gram staining of all bacterial select agents.
    • If you want to remove Gram stained slides of select agents from registered space, you must validate in-house that the Gram stained slides do not contain viable agent.

    You can find the full regulatory interpretation on this topic 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.

  • 6/26/17 - Updated Inactivation Guidance Document Now Available

    Today, the Federal Select Agent Program (FSAP) released an updated version of its inactivation guidance document, Guidance on the Inactivation or Removal of Select Agents and Toxins for Future Use

    Changes have been made throughout the document for clarity and to update the recordkeeping section of the document to reflect the recent FSAP regulatory interpretation regarding the inactivation certificates as it relates to external and intra-entity transfers.

    This and other FSAP guidance documents are living documents, which we will continue to update and refine over time. 

    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 DSATScienceoffice@cdc.gov for CDC/DSAT entities.


  • 6/23/17 - Update Regarding the New Electronic Federal Select Agent Program Information System: Changes in Submission Process for Registration and Inspection-Related Documents

    The Federal Select Agent Program (FSAP) is transitioning to a new secure information system that will contain select agent program information from all registered entities.  When completed, all registered entities will be able to review/print their current registration, submit all amendments, submit supporting documentation, and communicate with FSAP via the electronic portal.

    The FSAP is pleased to announce that it has begun the process of migrating all current APHIS/CDC Form 1 information into the new secure information system.  Soon, the FSAP will be issuing Secure Access Management Services (SAMS) account invitations to all Responsible and Alternate Responsible Officials currently registered with the FSAP so that they may access their select agent and toxin information in the new system and directly manage their registration information.  FSAP expects initial release of the new database system to all entities by late summer.

    The FSAP is committed to ensuring that new APHIS/CDC Form 1 amendments and updates to any pending amendments continue to be accepted and processed during the migration of existing entity data.  In order to ensure continuity of operations during the data migration, effective Monday, June 26, submission of all APHIS/CDC Form 1 documents should proceed as follows:

    1. For submission by email, entities registered with the Centers for Disease Control and Prevention, Division of Select Agents and Toxins, should use the following email address:  dsatops@cdc.gov.  Entities registered with the Animal and Plant Health Inspection Service, Agriculture Select Agent Services should use the following email address:  agsas@aphis.usda.gov.  Please do NOT send documents to your file manager’s email account.  Begin the subject line of the email with the name of your entity exactly as indicated on section 1 of your latest approved APHIS/CDC Form 1. 

    2. For submission by facsimile, entities registered with the Centers for Disease Control and Prevention, Division of Select Agents and Toxins, should use fax number 404-471-8425.  Please do NOT use 404-718-2096.  Entities registered with the Animal and Plant Health Inspection Service, Agriculture Select Agent Services should use the following fax number 301-734-3652.  You must include your entity’s name in the fax cover sheet or cover letter accompanying your submission.

    All entities should continue to submit all other FSAP documents – APHIS/CDC Form 2 (“Request to Transfer Select Agents and Toxins”); APHIS/CDC Form 3 (“Report of Theft, Loss, or Release of Select Agents and Toxins”); and APHIS/CDC Form 4 (“Report of the Identification of a Select Agent or Toxin”) – in the same manner as you have done in the past.  For questions and general correspondence, continue to use your file manager’s email account or telephone number.

    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.


  • 6/19/17 - Regulatory interpretation regarding requirement for inactivation certificates and intra-entity transfers

    In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation regarding whether there is a requirement for a copy of an inactivation certificate signed by a Principal Investigator (PI) to accompany “routine inactivation of materials being tested at a lower biocontainment level in the same building.”

    The inactivation certificate is only required when the material is transferred externally (entity to entity). It is recommended that an inactivation certificate accompanies intra-entity transfers of inactivated material internally (PI to PI). Additionally, regardless of the type of subsequent transfer, an entity remains responsible for the recordkeeping requirements found in section 17(a)(8) of the select agent and toxin regulations.

    Separately, the interpretation also notes that a contractor can be designated as a PI.

    You can find the full regulatory interpretation on this topic 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.


  • 6/02/17 - Permits for Asian lineage H7N9 strains

    On February 18, 2017, the OIE (World Organisation for Animal Health) reported samples obtained from live bird markets in China, sent to the National Reference Laboratory for Avian Influenza by the Guangdong veterinary authorities, tested positive for H7N9 highly pathogenic avian influenza virus [1] (HPAIV). Retrospectively, samples were identified as H7N9 HPAIV in Guangdong extending back to as early as October 2016. This Asian lineage H7N9 HPAIV is not related to the recent finding of North American wild bird lineage H7N9 HPAIV in United States (US) poultry during March 2017.

    The Asian H7N9 lineage was first reported in February 2013 as a low pathogenic avian influenza virus (LPAIV) which continues to circulate primarily in live bird markets in China, and causes human morbidity and mortality. As of April 2017, the Asian lineage H7N9 HPAIV has been isolated from poultry, the environment, and from people (http://www.fao.org/ag/againfo/programmes/en/empres/h7n9/situation_update.html).

    In light of these recent findings, additional supporting information will now be required for facilities requesting Asian lineage H7N9 strains in order to differentiate LPAIV from HPAIV. HPAIV is a USDA VS Select Agent, and may only be possessed, used or transferred in the United States by entities registered with the Federal Select Agent Program.

    In general, any request to receive low pathogenicity avian influenza A viruses for import and/or interstate transportation requires a VS 16-6 permit from the National Import Export Service (NIES), Organisms and Vectors (OV) Unit. This permit can be requested via the VS 16-3 permit application.

    As of the date of this notice, facilities requesting to receive Asian lineage H7N9 LPAIV will also be required to obtain a letter of exclusion at the time of the VS 16-3 permit application submission, which indicates that the material requested demonstrates a low pathogenicity phenotype. To obtain a letter of exclusion, provide either A) HA-gene sequence data consistent with H7N9 LPAIV genotype, and in vivo testing per OIE indicating a low pathogenic phenotype (either intravenous pathogenicity index [IVPI] of <1.2, or chicken lethality assay), or B) next generation full genome sequence data with depth of coverage >1000-fold to aid in excluding the potential of co-infection/ contamination with a high pathogenicity genotype, and duplicate plaque characterization testing using chicken embryo fibroblast cells (or other suitable cell line) with and without trypsin. Data should be sent to Agsas@aphis.usda.gov.

    A facility requesting to receive Asian lineage H7N9 LPAIV will also be required to request a letter of exclusion from APHIS (indicating that the material requested demonstrates a low pathogenicity phenotype) at the time of the VS 16-6 permit application submission.

    Permit application requests to Centers for Disease Control (CDC) for the importation of Asian lineage H7N9 strains will be held by CDC until an approved APHIS VS 16-6 permit is submitted to the CDC Import Permit program as supporting documentation.

    Movement of all other HPAI material requires an APHIS/CDC Form 2 “Request to Transfer Select Agents and Toxins”.

    Additional information related to avian influenza viruses can be found here.

    If you have any questions regarding this notice, please contact the Federal Select Agent Program at 301-851-3300 option 3 (8:00 am to 4:30 pm Eastern) or agsas@aphis.usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

    [1] There are molecular and biologic criteria, specific to chickens, which define an avian influenza virus as either low or high pathogenicity. Such criteria do not address infectivity nor pathogenicity in humans.


  • 5/18/17 - Publication of CDC’s 2016 DSAT Inspection Report Processing Annual Summary

    Today, CDC’s Division of Select Agents and Toxins (DSAT) has published its second annual analysis of inspection report timeliness, the 2016 DSAT Inspection Report Processing Annual Summary

    Inspection reports play a critical role in ensuring the safety and security of work with select agents and toxins.  These reports contain findings from inspections conducted by the Federal Select Agent Program (FSAP) and detail any corrective actions needed – therefore, timely issuance allows entities to take action and promptly address any concerns. 

    The new report (available here) analyzes inspection report timeliness throughout 2016, examining the length of time required to issue a report following an inspection (for both final reports and new interim reports), as well as associated variables.  For those reports with delays, the analysis also looks at the reason for those delays. 

    This second annual report comes as a result of program improvement recommendations made to DSAT in late 2015.  All DSAT-led inspections conducted as part of FSAP, including joint inspections with colleagues at the Agriculture Select Agent Services, are included in the data.

    Key findings include:

    • DSAT made substantial improvements in its ability to provide timely feedback to entities -- through the introduction of new interim reports as well as by reaffirming its commitment to issuing final reports within 30 days after an inspection.
    • Improvements in report timeliness occurred across all inspection types where there was room for improvement.
    • Inspection type is a reliable predictor of report timeliness, with complex maximum containment inspections taking the longest to complete.

    The findings also underscore the importance of routine analyses of reasons for any delays, because the earlier these issues can be identified, the quicker they can be addressed to prevent reoccurring concerns.

    These substantial improvements in timeliness reflect DSAT’s commitment to improving the program over the past year, and the publication of today’s report represents our continued pledge to increase transparency and understanding of the program.  However, despite the signs of progress detailed in this report, our work here is not done – we will continue to work towards further improvement.

    If you have any questions about the report, please contact DSAT at 404-718-2000 or DSATScienceoffice@cdc.gov.


  • 5/17/17 - Updated Select Toxin Guidance Document Now Available

    Today, the Federal Select Agent Program (FSAP) has released an updated version of its select toxin guidance document.  The document is available here and includes updates to the section regarding the reporting requirements for identification of a select toxin (APHIS/CDC Form 4).  The updates clarify the circumstances in which original food and clinical samples are excluded from the requirements of the regulations.

    This and other FSAP guidance documents are living documents, which we will continue to update and refine over time. 

    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 DSATScienceoffice@cdc.gov for CDC/DSAT entities.

  • 5/16/17 - New Biosafety Plan Template Now Available

    The Federal Select Agent Program (FSAP) has posted a new template online (available here) to assist entities in developing biosafety/biocontainment plans that meet the requirements found in section 12 of the select agent regulations.  The template is customizable to fit the specific needs of the entity.

    This document is provided as a resource. FSAP does not require use of this specific template. 

    A previous version of the template was shared with the regulated community for feedback.  In the process of finalizing the document, information on occupational health programs has now been incorporated into this template. 

    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.

  • 5/12/17 - FSAP Policy Statement: Meaning of the phrase “a deviation from a validated inactivation procedure or a viable select agent removal method”

    The Federal Select Agent Program (FSAP) has developed a policy statement to clarify new regulatory requirements for the inactivation of select agents which call for the Responsible Official (RO) to “investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material.” The regulations state that if the RO is “unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives a report of any inactivation failure after the movement of material to another location, the Responsible Official must report immediately by telephone or email the inactivation or viable agent removal method failure to CDC or APHIS.” See 42 C.F.R. § 73.9(a)(8), 9 C.F.R. § 121.9(a)(8), 7 C.F.R. §331.9(a)(8).

    It was and is the intent of the FSAP that the use of the phrase “a deviation from a validated inactivation procedure or a viable select agent removal method” means “a failure of a validated inactivation procedure or a viable select agent removal method.”

    This policy is posted here.

    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.


  • 5/11/17 - FSAP policy for approving transfers to non-possessor entities

    The Federal Select Agent Program (FSAP) recognizes that there are several parts of the select agent and toxin regulations (e.g. biosafety, security, and inventory) that are not required to be followed by an entity that is registered with the program but does not possess a biological select agent or toxin. 

    A “non-possessor” entity is an entity that may be registered for one or more select agents and/or toxins but does not currently possess any select agents or toxins.  There are some entities that are currently registered with FSAP that have been non-possessors for several years. 

    A non-possessor entity could potentially receive a select agent or toxin without FSAP having the opportunity to verify that the entity has implemented the proper biosafety and security requirements for working with the select agent or toxin.

    As of May 11, 2017, it is FSAP policy that FSAP will not approve the transfer of a select agent or toxin to a registered non-possessor entity until FSAP is able to verify that the non-possessor entity can be in compliance with all sections of the select agent and toxin regulations at the time of possession. This verification may involve an inspection of the non-possessor entity. 

    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.


  • 4/28/17 - Access control systems

    It has come to the attention of the Federal Select Agent Program (FSAP) that certain access control systems (ACS) may automatically delete some data when an access badge is inactivated. For these ACS, the date and time of entry of an individual’s badge number is retained, but the name field becomes blank.

    This ACS technical issue could cause an entity to have an inadvertent departure from the select agents and toxins regulations. Section 17(a)(5) of the regulations requires the recording of “all entries into areas containing select agents or toxins, including the name of the individual, name of the escort (if applicable), and date and time of entry.” Furthermore, section 17(c) of the regulations requires that “all records created under this part must be maintained for 3 years.” If the ACS is deleting the “name” in less than 3 years, the record of entry is no longer available to either the entity or to FSAP.

    Due to this issue, entities are encouraged to proactively manage their ACS. For example, one entity began backing the access records up as spreadsheets; this was done monthly. Another entity met the requirements by mapping the badge number to the (deleted) name. These methods were accepted by FSAP, but there may be others that work best for you.

    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.

  • 4/27/17 - Updated Inactivation Guidance Document Now Available

    Today, the Federal Select Agent Program (FSAP) has released an updated version of its inactivation guidance document, Guidance on the Inactivation or Removal of Select Agents and Toxins for Future Use. The updated guidance addresses feedback received from the regulated community since the original document was posted online in March.

    Most notably, changes in the updated document include the following:

    1. Clarification that the new inactivation regulations do not pertain to select toxins.
    2. Clarification on the level of surrogates that can be used for viruses, bacteria, and regulated nucleic acids.
      • Since the final rule went into effect, the regulated community asked FSAP to consider a broader use of surrogate organisms to validate an inactivation procedure for select agents.
      • Based on input from subject matter experts, FSAP will recognize the use of viruses from the same family as suitable surrogates for select agent viruses, bacteria from the same genus as suitable surrogates for select agent bacteria, and any positive single strand RNA as suitable surrogates for regulated positive single strand RNA.
    3. Updates to the section dealing with validation to reflect the recently issued FSAP Policy Statement: Application of the requirement for a “validated inactivation procedure” as used in the select agent regulations.
    4. Updates to the section dealing with the inactivation certificate to reflect the recently issued FSAP Regulatory Interpretation regarding the requirement for a signature by “Principal Investigator” on inactivation certificates.

    This and other FSAP guidance documents are living documents, which we will continue to update and refine over time. We thank the regulated community for input provided to-date, and always welcome additional comments.

    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 DSATScienceoffice@cdc.gov for CDC/DSAT entities.
  • 4/24/17 - Regulatory interpretation regarding surrogate strains which can be used to validate inactivation procedures

    In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation regarding surrogate strains which can be used to validate inactivation procedures.

    The select agent regulations provide that surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure. However, the select agent regulations also provide that if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains. See, for example, 42 C.F.R. § 73.3 (d)(4).

    For purposes of the requirement found in 42 C.F.R. §§ 73.3 and 4 (d)(4), 9 C.F.R. §§ 121.3 and 4 (d)(4), and 7 C.F.R. § 331.3 (d)(4),

    • Viruses from the same family can be suitable surrogates for select agent viruses,
    • Bacteria from the same genus can be suitable surrogates for select agent bacteria, and
    • Any positive single stranded RNA can be suitable surrogates for regulated positive single stranded RNA.

    You can find the full regulatory interpretation on this topic 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.

  • 4/19/17 - Revised policy statement regarding the inactivation of Bacillus anthracis and Bacillus cereus Biovar anthracis

    In response to the recently amended select agent regulations, the Federal Select Agent Program (FSAP) has issued a revised policy statement regarding the inactivation of Bacillus anthracis and Bacillus cereus Biovar anthracis.

    The revised policy replaces the previous FSAP policy statement on the subject (issued September 30, 2016).  All elements of the revised policy take effect immediately. 

    The policy is available online at http://www.selectagents.gov/policystatement_bacillus.html.   Key changes are as follows:

    1. Updated regulatory citations in the policy to reflect amended regulatory language that became effective on March 21, 2017.
    2. Modified the incubation temperature to align with recognized incubation standards.
    3. Required initial in-house validation of all inactivation or removal procedures using 100% of the sample or filtering of 100% of the sample and then culturing the filter.

  • 4/13/17 - Regulatory interpretation regarding signature by “Principal Investigator” on inactivation certificates

    In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation regarding the requirement for a “Principal Investigator” to sign a certificate for select agents or materials containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agent. See, for example, 42 C.F.R. § 73.17 (a)(8)(vii).

    For purposes of the requirement found in 42 C.F.R. § 73.17 (a)(8)(vii), 9 C.F.R. § 121.17(a)(8)(vii), and 7 C.F.R. § 331.17 (a)(8)(vii), the Principal Investigator is the one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program (including all inactivation procedures or removal procedures associate with that project); or in the absence of that Principal Investigator, the individual designated by that Principal Investigator and approved by the entity Responsible Official to sign the certificate in his or her absence. In order for an individual to be the Principal Investigator’s designee to sign the certificate, a person must be listed on the entity’s registration and have the knowledge and expertise to provide scientific and technical direction regarding the validated inactivation procedure or the procedure for removal of viable select agent to which the certificate refers.

    You can find the full regulatory interpretation on this topic at https://www.selectagents.gov/policystatement_pi.html.

    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.

  • 4/12/17 - Publication of final rule for Bacillus cereus Biovar anthracis

    Today, HHS/CDC adopts the interim final rule adding B. cereus Biovar anthracis to the list of HHS select agents and toxins, to be regulated as a Tier 1 agent, as final without change. The interim final rule was effective on October 14, 2016.

    The final rule was published today in the Federal Register (available here), along with a response to public comments. CDC received two comments, both of which supported the rule change.

    In accordance with the interim final rule, any individual or entity that in possession of B. cereus Biovar anthracis is required to either register in accordance with 42 CFR Part 73 or amend their current registration in accordance with 42 CFR § 73.7(h) and meet all of the requirements of the select agent regulations (42 CFR Part 73).

  • 4/6/17 - Final FSAP policy statement regarding the application of the phrases “conclusion of patient care” or “delivery of patient care by health care professionals has concluded” as used in the select agent regulations

    The Federal Select Agent Program (FSAP) has issued a final policy statement outlining the application of the phrases “conclusion of patient care” or “delivery of patient care by health care professionals has concluded” as used in the select agent regulations.

    As of April 6, 2017, it is the policy of the Federal Select Agent Program that for an individual who has been admitted to a medical facility, that individual’s “conclusion of patient care” and the point when “delivery of patient care by heath care professionals has concluded” is when that individual has been released from the medical facility where treatment was being provided. The select agent regulations regarding select agent waste generated during the delivery of patient care apply only to the treatment of humans. Accordingly, specimens or waste associated with that individual (e.g., tissue samples, body fluids, fomites and any other contaminated material likely to transmit an infection to people through the environment if it is unable to be decontaminated) must be destroyed or transferred to a registered entity within seven days after an individual’s release from a medical facility.

    This policy is attached and will be posted online here.

    A draft of this policy was previously shared with the regulated community for feedback. As a result of feedback received during this period, revisions were made to clarify that this policy only applies to the treatment of humans who receive patient care at a medical facility and to provide examples of waste associated with those individuals.

    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.


  • 4/6/17 - FSAP Policy Statement: Application of the requirement for a “validated inactivation procedure” as used in the select agent regulations

    The Federal Select Agent Program (FSAP) has developed a policy statement to clarify new regulatory requirements for the inactivation of select agents, as outlined in the select agent regulatory sections 3(d)(4) and 4(d)(4). These sections now provide that a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus is excluded from the requirements of the select agent and toxin regulations if it meets the following criteria: it “has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol."

    It is the policy of FSAP that section 3(d)(4) and section 4(d)(4) exclusion provisions require that the validation of the inactivation procedure must be performed in-house by the entity when the procedure will be used to inactivate a select agent or nucleic acids that can produce infectious forms of any select agent virus.

    This policy is attached and will be posted online at https://www.selectagents.gov/policystatement_inactivation.html

    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 DSATScienceoffice@cdc.gov for CDC/DSAT entities.


  • 3/27/17 - Rescheduled Federal Select Agent Program Webcast – April 28

    As recently announced in the Federal Register, the Federal Select Agent Program (FSAP) will host a webcast on April 28, 2017 from 12:00 p.m. to 4:00 p.m. EDT. The purpose of the webcast is to provide guidance related to the amended select agent regulations. A more detailed agenda will be forthcoming.

    Anyone who wishes to participate in the rescheduled webcast must pre-register via the FSAP website (http://www.selectagents.gov/webform.html) before April 14. There is no charge for registration. The webcast link and supporting information will be sent to registered participants prior to the webcast. Participants that had already registered for the previously scheduled webcast date will not need to re-submit registration requests for the new date.

    If you have any questions regarding this webcast, please contact the FSAP via CDC (Diane Martin, lrsat@cdc.gov) or APHIS (Dr. Charles Divan, AgSAS@aphis.usda.gov).


  • 3/21/17 - Updated Select Agent and Toxin Guidance Documents Now Available

    In response to the recently amended select agent regulations, the Federal Select Agent Program has updated its series of guidance documents.

    The following guidance documents are now available online:


    We thank the regulated community for feedback provided on the draft documents. Please note that these are living documents, which we will continue to update and refine over time. Further input on the guidance documents is always welcome, and will be taken into account for future updates.

    For your reference, we have also updated the Frequently Asked Questions posted on our website (see https://www.selectagents.gov/faq.html) and will continue to do so over time.

  • 2/15/17 - Delay in Effective Date of Amendments to the HHS/USDA Select Agent Regulations

    Today, notice was put on display in the Federal Register that the effective dates for the recently published HHS/CDC and USDA/APHIS amendments to the select agent regulations (i.e., final rules) have been delayed.  With these Federal Register notices, the agencies announce a new effective date for these regulations of March 21, 2017.  The information will officially publish on Thursday, February 16 on the Federal Register website.

    This action is undertaken in accordance with the Reince Priebus memorandum of January 20, 2017, which directed the heads of executive departments and agencies to temporarily postpone for sixty days from the date of the memorandum the effective dates of all regulations that had been published in the Federal Register but had not yet taken effect.

    As a reminder, you can find the full text of the amendments to the regulations available at the following links:


    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.

  • 2/13/17 - Regulatory Interpretation - Synthetically Created DNA Sequence

    In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation on whether synthetically created DNA sequences would be considered a select agent or toxin as defined by sections 3(c)(3) and 4 (c)(3) of the select agent regulations, which states  “…select agents and toxins that have been genetically modified” are select agents and toxins.

    You can find the full regulatory interpretation on this topic at https://www.selectagents.gov/policystatement_DNA.html.

    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.


  • 2/09/17 - Changes to Registration Renewal Process

    In order to streamline the registration renewal process and decrease the burden on the regulated community, the Federal Select Agent Program (FSAP) has recently implemented a significant change to this process.  Effective immediately, FSAP will no longer require an entity to submit a comprehensive Form 1 at the time of the entity’s registration renewal. 
    The new process will be as follows:

    • Six months prior to the entity’s registration renewal date, the Responsible Official will receive a notice via email that contains:
      • A notice of registration renewal
      • A list of all security risk assessment (SRA)-approved and non-approved individuals at the entity
      • A summary of the entity’s currently registered agent(s), space(s), and PI(s)
    • The RO/ARO must provide a written verification to the entity’s file manager that the information contained in the documents is accurate at least 30 days prior to the entity’s renewal inspection.
    • If the information contained in the documents is inaccurate, your file manager will work with you to submit an amendment to your registration.  Any required changes to information captured on the Form 1, including work objectives, should be submitted via an amendment at this time. The amendment process will remain the same. 


    The rest of the registration renewal process will remain the same.  Please be reminded that:

    • As a condition of the renewal of your registration, the Responsible Official, Alternate Responsible Official(s), and any individual who owns or controls the entity must have had a SRA conducted within the last three years, prior to the entity’s expiration date.
    • FSAP will continue to request additional documentation, such as the submission of the entity’s biosafety, security, and incident response plans, closer to the date of the renewal inspection.

    If you have any questions or concerns regarding this new process, 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.


  • 1/26/17 - Use of Typed Initials on the FD 961

    We have noticed an increase in cancelled security risk assessments (SRAs) because of typed initials on the FD 961.

    All initials on the FD 961 must be handwritten. CJIS will not accept typed initials on any part of the FD 961. Failure to do so will result in your SRA application or renewal being cancelled.

    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.

  • 1/19/17 - Publication of Amendments to the HHS and USDA Select Agent Regulations

    Today, HHS and USDA have published parallel amendments to federal regulations for work with select agents and toxins.  The regulatory amendments include critical changes to the requirements that must be followed by those working with select agents and toxins, and aim to increase the safety and security of work with these materials. 

    Key components include:

    • Changes to the toxin permissible limits
    • Addition of specific requirements that must be followed for the inactivation of select agents
    • New provisions to the biosafety sections
    • Clarifications to the regulatory language regarding security, training, incident response, and records
    • Clarification that each registered entity must comply with the regulations for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin 

    No changes are being made to the list of select agents and toxins at this time.

    The amendments take effect 30 days from the date of publication and are available at the following links:


    The publication of these amendments reflects the culmination of an extensive process, and includes input received from public comments and federal advisory bodies.  Elements are also responsive to recommendations received through recent program reviews.

    Multiple efforts are underway by the Federal Select Agent Program (FSAP) to help registered entities comply with the regulations.  FSAP is updating current guidance documents, as well as developing new guidance, and will be holding an upcoming webcast to address the changes and provide an opportunity to ask questions about the regulations.

    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.

  • 1/12/17 - Select Agent Program Webcast Postponed

    Due to a scheduling conflict, the Federal Select Agent Program (FSAP) webcast – originally scheduled for February 8, 2017 from 12:00 PM to 4:00 PM EST – has been postponed. Details on a new date will be forthcoming once confirmed. An announcement will also be published in the Federal Register.

    Participants that have already registered for the webcast will not need to re-submit registration requests for the new date. 

    If you have any questions, please contact the FSAP via CDC (Diane Martin, lrsat@cdc.gov) or APHIS (Leon White, AgSAS@aphis.usda.gov).


  • 1/10/17 - Updated APHIS/CDC Form 3 (Report of Theft, Loss, or Release of Select Agents and Toxins) Now Available for Public Comment

    The Federal Select Agent Program (FSAP) wishes to share the following information for your awareness.

    The Department of Health and Human Services recently published a “60-day notice” in the Federal Register. The purpose of the notice is to seek official public comment on FSAP’s request through the Office of Management and Budget to revise the APHIS/CDC Form 3, which is used by entities to report theft, loss, or release of a select agent or toxin. Revisions seek to further clarify what needs to be reported as a ‘‘release’’ and ‘‘loss’’ and include additional fields to assist with categorizing the type of release (e.g., spill within secondary containment, occupational exposure, possible breach of facility containment, etc.), type of exposure, and the understanding of safety and security risk levels relative to human illness.

    Efforts to update APHIS/CDC Form 3 follow recent recommendations for program improvement, and an earlier version of this revised document was informally shared by FSAP with the regulated community for feedback in fall 2016. The updated version that is now being shared for official public comment incorporates feedback received during that period.

    To request more information, obtain a copy of the proposed form, or submit comments, please contact CDC’s Information Collection Review Office, 1600 Clifton Road, NE., MS–D74, Atlanta, Georgia 30329 or send an email to omb@cdc.gov. Written comments must be received on or before February 28, 2017.

  • 1/06/17 - Final FSAP policy statement regarding the specific circumstances in which a registered entity may allow a “restricted person” into an area containing a select agent or toxin

    The Federal Select Agent Program (FSAP) has issued a final policy statement outlining the specific circumstances in which a registered entity may allow a “restricted person” into an area containing a select agent or toxin. 

    As of January 6, 2017, it is the policy of the Federal Select Agent Program (FSAP) that a registered entity may allow a “restricted person” into an area containing a select agent or toxin only if the entity meets all of the following conditions:

    • The restricted person is never allowed to have access to any select agent or toxin.  An individual will be deemed to have such access at any point in time if the individual has possession of a select agent or toxin (e.g., ability to carry, use, or manipulate) or the ability to gain possession of a select agent or toxin.  (See section 10 (b) of the select agent regulations.)
    • The entity’s security plan specifically addresses how the entity will safeguard select agents and toxins against theft, loss, release, or unauthorized access when a restricted person is present in an area containing a select agent or toxin.
    • The entity’s Responsible Official receives prior notification of the individual’s need for access to the area in which a select agent or toxin is stored or in use and approves the entry of the restricted person into an area containing a select agent or toxin.  
    • For all registered areas the restricted person will enter, the entity secures all select agents and toxins against unauthorized access while the restricted person is in a registered area (e.g., select agents or toxins are removed from the area or agents and toxins are secured in containers that would not allow access by the restricted person) as described in the entity’s security plan.
    • The restricted person is continuously escorted and monitored by an entity representative with FSAP approval to access select agents and toxins. The designated entity escort must be aware of their duty to not allow the restricted person access to a select agent or toxin. 


    This policy is attached and will be posted online at www.selectagents.gov.

    A draft of this policy was previously shared with the regulated community for feedback.  As a result of feedback received during this period, revisions were made to clarify that this policy describes the only acceptable, specific conditions in which a registered entity may allow a “restricted person” into an area containing a select agent or toxin (i.e., not just examples of what those conditions may be). 

    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.