What's New

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 strainand 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.





  • 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.


  • 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.


  • 4/12/17 - 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).


  • 4/06/17 - 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 posted online at https://www.selectagents.gov/policystatement_inactivation.html.


  • 4/06/17 - 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 posted online at https://www.selectagents.gov/policystatement_patient.html.


  • 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 for the workshop via the FSAP website 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.


  • 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:


    Please note that these are living documents, which we will continue to update and refine over time. 

    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:



  • 1/30/17 - Update on Community Engagement and Transparency

    Beginning in late 2015 and continuing today, FSAP has implemented – and continues to implement – a number of program changes that address a recommendation from the Fast Track Action Committee on the Select Agent Regulations to increase peer-to-peer involvement with FSAP.

    FSAP posted an update on its efforts to ensure that the regulated community has the opportunity to provide input into the program on an ongoing basis. Click here to read more.


  • 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.


  • 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.