SA Grams - 2022 | Resources | Federal Select Agent Program

The Federal Select Agent Program (FSAP) received a request for a regulatory interpretation regarding the validation of inactivation procedures for regulated nucleic acids. The FSAP response is as follows:

The select agent and toxin regulations provide that “[n]ucleic acids that can produce infectious forms of any of the select agent viruses” are select agents. 42 CFR § 73.3(c)(1), 7 CFR § 331.3(c)(1), and 9 CFR § 121.3(c)(1). Therefore, to qualify for the exclusion in 42 CFR § 73.3(d)(4) [or the identical exclusions in 42 CFR § 73.4(d)(4), 7 CFR § 331.3(d)(4), and 9 CFR §§ 121.3(d)(4), 121.4(d)(4)] of the select agent and toxin regulations, regulated nucleic acids that can produce infectious forms of any select agent virus must be subjected to a validated inactivation procedure that is confirmed through a viability testing protocol to ensure the nucleic acids are incapable of producing infectious select agent virus. Therefore, entities must determine that the RNA has been rendered incapable of producing infectious virus in order to qualify for the exclusion in 42 CFR § 73.3(d)(4). For more information on viability/infectivity testing of regulated nucleic acids, please see the section on “Infectivity Testing of Inactivation Procedures” in the “Guidance on the Inactivation or Removal of Select Agents or Toxins for Future Use” (Guidance on the Inactivation or Removal of Select Agents and Toxins for Future Use [PDF – 1 MB]).

You can find the full regulatory interpretation on this topic at the Regulatory Interpretation for Validation of Inactivation Procedures for Regulated Nucleic Acids.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another update to the electronic Federal Select Agent Program (eFSAP) Information System.

Beginning December 9, 2022, eFSAP information system users will notice the following system updates:

General Discussion Conversation Mode

eFSAP now includes an optional setting for general discussion messages, “Conversation Mode”
Users can reply to messages directly from the home page rather than having to navigate to the amendment or specific Form 2, 3, or 4 to reply
The conversation generated from the home page will automatically mirror on the Form or amendment
Replies from the Form or amendment will likewise carry over to the home page
Users are also able to generate and reply to new conversations from the home page that may not be specific to any Form or amendment

For more information, please review the tutorial [PDF – 2 MB] with screenshots of the new features attached to this message.

Please note: Users must clear their internet browser cache/cookies for the system to function properly. Instructions can be found on the eFSAP Resource Center page.

FSAP would like to thank the regulated community for its continued feedback regarding eFSAP information system functionality. We look forward to delivering continued improvements based upon your suggestions.

If you experience errors, have questions, or have challenges with 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 reference our newly updated eFSAP user manual.

In June 2022, the Federal Select Agent Program (FSAP) shared an updated draft of the Inventory Guidance document with the regulated community for review and input. The updates included adding a labeling guidance appendix and other edits to enhance material accountability. The September update of the Inventory Guidance document has been further revised based on comments received and can now be found here.

Summary of comments and edits:

One commenter requested that a note be added about exempting of clinical specimens during the course of clinical care.
- FSAP agreed with the commenter and added a sentence referencing Section 5(a)(3) under “Regulated select agents and toxins” (page 5).

Two commenters requested clarification regarding working stock records.
- FSAP clarified in the document that the select agent regulations do not require entities to maintain inventory records in accordance with Section 17(a)(1) for working stock. However, FSAP expects entities be able to clearly identify how and why material is classified as working stock.

Two commenters requested leeway in reporting toxin losses when the root cause is clearly due to sublimation, age of samples and/or process loss, or below a “permissible limit.”
- FSAP made no changes based on this comment. An entity is responsible for maintaining an accurate and current inventory of all registered toxins possessed, regardless of the amount in their possession as stated in Section 7(b).

One commenter stated that the example of grouping specimen vials with date of storage on the primary and secondary container is not practical or feasible.
- FSAP clarified that the example provided on page 9 is a suggestion and is not a regulatory requirement, however, entities are required to maintain an accurate and current inventory of all specimens.

One commenter suggested that the length of time records be kept should be included.
- FSAP agreed with commenter and revised document in accordance with Section 17(c).

FSAP received multiple comments regarding Appendix 1: Labeling Guidance and whether or not this guidance was required.
- Please note that Appendix 1: Labeling Guidance is guidance and not a regulatory requirement. For inventory requirements, please reference Section 17(a)(1,2,3).

Two commenters were confused about “unique linkage” and asked for a definition or an example of what this meant under Appendix 1: Labeling Guidance.
- Upon further review, FSAP agreed with the commenter and deleted the bullet.

Two commenters asked if secondary containers were required to have the same information as the primary vial regarding the last paragraph in Appendix 1: Labeling Guidance.
- FSAP agreed with the commenter and revised the last paragraph in Appendix 1: Labeling Guidance.

The HHS Select Agent and Toxin Regulations require entities, unless directed otherwise, to report the identification of a select agent or toxin to the Division of Select Agents and Toxins (DSAT) within seven days of identification by submitting an APHIS/CDC Form 4 (Report of the Identification of a Select Agent or Toxin). Monkeypox virus is a select agent. See 42 CFR Part 73.

In accordance with the HHS Select Agent and Toxin Regulations, 42 C.F.R. § 73.5 (a)(4)(iii), DSAT has authorized less stringent reporting requirements for the identification of monkeypox virus due to the 2022 Monkeypox Outbreak:

Until the conclusion of the monkeypox virus outbreak as determined by the Centers for Disease Control and Prevention, clinical and diagnostic labs and other entities that possess HHS select agents and toxins may submit one consolidated report, using the APHIS/CDC Form 4, to report all identifications of monkeypox virus for a 180-day period. All monkeypox virus positive samples, not characterized to clade level or identified as Clade I of the monkeypox virus, can be submitted on a single APHIS/CDC Form 4 with an accompanied spreadsheet listing the different sample providers, as long as the form submission date is within 180 days of the earliest sample identification date.

Please note, Clade II (West African Clade) monkeypox virus is excluded from the select agent regulatory requirements, including identification reporting. Therefore, samples that have been identified to be or contain Clade II (West African Clade) monkeypox virus, do not need to be reported to DSAT. However, each identification of monkeypox virus, clade undetermined, or Clade I (Congo Basin Clade) monkeypox virus must be reported to DSAT using an individual or consolidated APHIS/CDC Form 4 report.

If an entity reports an identification of monkeypox virus, clade undetermined to DSAT and the sample is later determined to be the excluded Clade II (West African Clade) of monkeypox virus, the entity should update DSAT once the identification is known by sending an email to CDCForm4@cdc.gov. The entity should also update the identification to the recipient of the sample material if previously transferred.

This is a notification that the IT Call Center will no longer be functional, including the current phone number (877-232-3322).

Any future requests for IT support regarding the eFSAP Information System, can now be made by:

Phone: 404-718-2000
Online: By completing a Customer Support Request Form
E-mail: eFSAPsupport@cdc.gov

Currently, there are two clades of Monkeypox virus: Congo Basin clade (Clade I) and West African clade (Clades IIa and IIb). Up to this point in the 2022 U.S. Monkeypox Outbreak, laboratory testing has indicated that the current outbreak is associated with the Clade IIb of Monkeypox virus.¹

CDC’s Division of Select Agents and Toxins (CDC/DSAT) is issuing this SA Gram to clarify the regulatory status of materials (patient samples, cultures, diagnostic materials, etc.) related to the 2022 U.S. Monkeypox Outbreak.

Monkeypox virus is regulated as an HHS-only select agent [42 CFR 73.3(b)] and entities that possess, use, or transfer this agent must comply with the HHS Select Agent and Toxin Regulations [42 CFR 73] (“the regulations”) unless there is an applicable exemption or exclusion, such as the following:

West African Clade Exclusion (Clade IIa or IIb): The regulations provide that “any West African Clade of Monkeypox virus [is excluded from the requirements of the regulations] provided that the individual or entity can identify that the agent is within the exclusion category.” 42 CFR 73.3(d)(12).

This exclusion would apply to material that has been identified as being or containing West African Clade (Clade II) Monkeypox virus.

Diagnostic Specimen Exemption: The regulations provide that clinical or diagnostic laboratories or other entities that possess, use or transfer an HHS select agent contained in a specimen presented for diagnosis or verification will be exempt from the requirements of the regulations for such agent if the entity, 1) reports the identification of the agent to the Federal Select Agent Program (FSAP) and other authorities as required by law, 2) secures the select agent after identification, and 3) transfers or destroys the material, in accordance with 42 CFR 73.5(a).

This exemption would apply to material that has been identified as being or containing Monkeypox virus, but the clade has not been determined or the clade has been determined to be Congo Basin clade (Clade I). An entity may retain this material if registered with FSAP and approved to possess Monkeypox virus.

FSAP regulates material that has been identified as being or containing a select agent or toxin. Therefore, confirmed identifications of Orthopoxvirus that are presumptive identifications of Monkeypox virus², are not considered select agents by FSAP until identified to be Monkeypox virus or another select agent.

CDC/DSAT strongly recommends that entities possessing materials associated with the current outbreak ensure they comply with the applicable regulations and clearly label and inventory the samples as being associated with the 2022 U.S. Monkeypox Outbreak in case there are any future questions regarding the possessed material.

CDC/DSAT also recommends entities separate materials associated with the current outbreak from materials confirmed to be or confirmed to contain Congo Basin clade (Clade I) Monkeypox virus to prevent uncertainty in the inventory and cross contamination.

References

CDC Monkeypox Laboratory Procedures and Biosafety Guidelines (see: Select Agent Regulations). August 22, 2022. Available at: https://www.cdc.gov/poxvirus/monkeypox/lab-personnel/lab-procedures.html
CDC Official Health Update: Update for Clinicians on Testing and Treatment for Monkeypox (see: Orthopoxvirus Results Interpretation). July 28, 2022. Available at: https://emergency.cdc.gov/han/2022/han00471.asp?ACSTrackingID=USCDC_511-DM86728&ACSTrackingLabel=HAN%20471%20-%20General%20Public&deliveryName=USCDC_511-DM86728

Today, the Federal Select Agent Program (FSAP) published its seventh annual report of aggregate program data, the 2021 Annual Report of the Federal Select Agent Program. The report summarizes data for calendar year 2021 and is part of FSAP’s continued efforts to provide the American public with insight into the regulatory activities of the program. The annual publication of this report reflects FSAP’s ongoing commitment to transparency.

As in previous years, the content includes a look at the regulatory functions of FSAP, as well as compliance with the select agent regulations at laboratories across the nation. This year’s report provides insight into key ways the program has adapted to carry out its mission during the COVID-19 pandemic, as well as highlights FSAP’s efforts to engage with the regulated community throughout the year to ensure regulatory compliance.

Once again, the content of the report underscores that overall, most laboratories registered with the program are compliant with the regulations, and none of the small number of reported incidents during the year resulted in a significant risk to public or agricultural health.

The report summarizes aggregate program data in areas such as:

Numbers and types of registered entities, as well as amendments to registrations
Top registered select agents or toxins
Security risk assessments performed
Number of inspections conducted
Key observations related to inspection findings and compliance with the select agent regulations
Reported thefts, losses, and releases of select agents or toxins
Identifications and transfers of select agents or toxins
Publications and outreach activities

The full report, along with an infographic summarizing the key findings, is now available here.

The Federal Select Agent Program (FSAP) published two Federal Register Notices regarding the excluded attenuated strain Venezuelan Equine Encephalitis Virus (VEEV) TC-83 (CDC Notice, APHIS Notice). New information has shown that a modification to the excluded attenuated strain Venezuelan Equine Encephalitis Virus (VEEV) TC-83 (A3G) has been shown to increase its virulence. Therefore, the modified VEEV strain TC-83 (A3G) is a select agent and subject to the select agent regulations. More information is available here.

Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its annual analysis of inspection report timeliness data, the 2021 FSAP Inspection Report Processing Annual Summary.

Inspection reports play a critical role in ensuring the safety and security of work with select agents and toxins. Timely feedback following an inspection is essential so that FSAP can quickly get important information back to entities, therefore allowing the entities to promptly address any identified concerns.

The new FSAP analysis finds continued program success in providing timely feedback to entities following an inspection, with nearly all final inspection reports sent to entities in 2021 within the program’s goal of 30 business days.

Key findings include the following:

FSAP issued 201 final inspection reports in 2021 – with 99 percent of those (199/201) issued within the target timeframe of 30 business days. The average was 20 days.
The Centers for Disease Control and Prevention’s Division of Select Agents and Toxins issued 168 final inspection reports at an average of 20 days, and the Animal and Plant Health Inspection Service’s Division of Agricultural Select Agents and Toxins issued 33 final inspection reports at an average of 17 days.
All 6 immediate action observations were issued within the target timeframe of 10 business days. The average was 7 days.

Throughout 2021, FSAP continued to implement key changes to the inspection process due to the COVID-19 pandemic, including the use of multiple types of inspections to best meet the needs at each entity. Beginning in April 2020 and continuing into 2021, FSAP adjusted its inspection processes by adopting remote or hybrid (i.e., part on-site and part remote) inspections, due to travel restrictions and for the safety of FSAP inspectors and regulated entity staff, in addition to on-site inspections. These changes did not adversely impact timeliness or result in delays in issuing inspection reports, but rather, helped FSAP to become more efficient and continue to carry out its program mission despite the pandemic. Moving forward, FSAP will continue to use all available inspection types as needed and appropriate.

For more information, please see the full report, available here [PDF – 578 KB].

If you have any questions about the report, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@cdc.gov.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another update to the electronic Federal Select Agent Program (eFSAP) Information System.

Beginning June 8, 2022, eFSAP information system users will notice the following system updates:

Updated Personnel Statuses

Terminology in eFSAP regarding an individual’s access approval status has been updated to match terminology in the select agents and toxins regulations:

Terminology in eFSAP regarding an individual’s access approval status
Former eFSAP statuses	New eFSAP statuses
Unrestricted	Approved
Restricted	Denied/Restricted
	Revoked/Restricted
Denied	Denied (For Cause)
	Revoked (For Cause)
Withdrawn	Terminated

APHIS/CDC Form 2 Auto-Expiration

- Form 2s in ‘Approved Section 2 Pending’ status for 30 days will auto-expire on the 31st calendar day.
- Transfers set to expire within 7 days will show in bold on the grid table.
- Prior to the Form 2 being auto-expired, there will be notifications generated to the notifications grid table at 7, 3 and 1 day(s) prior to auto-expiration.

Progress Bar for Replacement of Principal Investigator
- When executing an amendment to replace a principal investigator, users are now provided a “progress bar” to track the status of the data changes.

Reclassification of File Uploads
- Users can reclassify previously uploaded files if needed.
- Reclassification does not affect the original upload date/time or the current review status.

For more information, please review the tutorial [PDF – 594 KB] with screenshots of the new features.

Please note: Users must clear their internet browser cache/cookies in order for the system to function properly. Instructions can be found on the eFSAP Resource Center page.

FSAP would like to thank the regulated community for its continued feedback regarding eFSAP information system functionality. We look forward to delivering continued improvements based upon your suggestions.

If you experience errors, have questions, or have challenges with 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; or, reference our newly updated eFSAP user manual [PDF – 641 KB].

If you have any questions regarding this email, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has updated the training section of its Suitability Guidance document and the frequently asked questions (FAQs) regarding trainings that are posted to the FSAP website to clarify that entities with Tier 1 select agents and toxins must conduct annual insider threat awareness briefings for all FSAP-approved personnel on the entity’s registration. The updated Suitability Guidance document and Training FAQs are available on the FSAP website.

Effective March 16, 2022, the Federal Select Agent Program (FSAP) excluded the attenuated ∆norD ∆znuA Brucella melitensis-mCherry (znBM-mC) strain from the select agent regulations [42 CFR 73.4(e) and 9 CFR 121.4(e)]. The znBM-mC strain contains the same two mutations as a previously excluded Brucella abortus strain [ΔnorDΔznuA Brucella abortus-lacZ (vaccine strain)] and a B. melitensis strain (∆norD ∆znuA Brucella melitensis-lacZ (znBM-lacZ). The ∆norD ∆znuA Brucella melitensis–mCherry strain was excluded based on data provided that demonstrated that the deletion of two virulence genes (norD and znuA) resulted in attenuation in both in vivo and in vitro assays. The selectagents.gov exclusion website has been modified to include the additional znBM-mC strain in the same listing as the znBM-lacZ strain.

If you have any questions regarding this email, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program recently received a request for a regulatory interpretation regarding constructs of botulinum neurotoxin genes. The Centers for Disease Control and Prevention/Division of Select Agents and Toxins response is as follows:

This is in response to your letter dated April 7, 2022, requesting clarification of which constructs containing genes encoding botulinum neurotoxin would be subject to the select agent regulations as outlined below and in 42 CFR § 73.3(c)(2). The regulatory provision provides:

73.3 (c) Genetic Elements, Recombinant and/or Synthetic Nucleic Acids, and Recombinant and/or Synthetic Organisms:
- (2) Recombinant and/or Synthetic nucleic acids that encode for the toxic form(s) of any of the toxins listed in paragraph (b) of this section 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.

The Division of Select Agents and Toxins (DSAT) has determined the following based on the submitted questions:

Are plasmids containing full-length botulinum neurotoxin genes without a promoter for expression of the neurotoxin gene (DNA only, cannot be expressed even in a bacterial strain) subject to the select agent regulations?

No. Plasmids containing genes encoding the full-length botulinum neurotoxin without a promoter for expression of the neurotoxin genes are not regulated nucleic acids because the plasmids cannot be expressed in vitro or in vivo as outlined in § 73.3(c)(2).

Are plasmids containing full-length botulinum neurotoxin genes with a promoter for expression of the neurotoxin gene (DNA only, can be expressed only in a bacterial expression strain) subject to the select agent regulations?

Yes. Plasmids containing genes encoding the full-length botulinum neurotoxin with a promotor for expression of the neurotoxin genes are regulated nucleic acids because the plasmids can be expressed in the bacterial strain as outlined in § 73.3(c)(2).

Are plasmids containing full-length botulinum neurotoxin genes with no promoter for expression of the neurotoxin gene in a bacterial strain subject to the select agent regulations?

No. Plasmids containing genes encoding the full-length botulinum neurotoxin without a promoter for expression of the neurotoxin genes in a bacterial strain are not regulated nucleic acids because the plasmids cannot be expressed in vitro or in vivo as outlined in § 73.3(c)(2).

Are plasmids containing full-length botulinum neurotoxin genes with a promoter for expression of the neurotoxin gene in a bacterial strain subject to the select agent regulations?

Yes. Plasmids containing full-length botulinum neurotoxin genes with a promotor for expression of the neurotoxin gene in a bacterial strain are regulated nucleic acids because the plasmids can be expressed in the bacterial strain as outlined in § 73.3(c)(2).

You can find the full regulatory interpretation on this topic here.

If you have any questions regarding this email, please contact 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has updated its APHIS/CDC Form 1 Guidance Instructions [PDF – 1 MB] to further clarify guidance provided for Section 7B—Strain or Serotype Designation and posted the updated document to the FSAP website. The APHIS/CDC Form 1 Guidance Instructions are used by entities to newly register with FSAP. For changing or updating a Form 1, see eFSAP Form 1 Amendment Instructions [PDF – 715 KB].

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@cdc.gov.

Effective May 30, 2022, the Federal Select Agent Program (FSAP) will no longer grant access approval extensions past the original access approval expiration date as indicated in the October 19, 2020, SA Gram entitled “Reminder Regarding Processing of Security Risk Assessments During the COVID-19 Pandemic.”

To assist the Federal Bureau of Investigation/Criminal Justice Information Service/Bioterrorism Risk Assessment Group (BRAG) with the processing of security risk assessments (SRAs), FSAP and BRAG would like to remind the regulated community of the following:

Per the FD-961 instructions, the applicant’s signature date must be current (occurring within the last 90 days).
For renewals, BRAG will not process FD-961 forms and/or fingerprint cards that are submitted more than 90 days prior to the applicant’s access approval expiration date.
For renewals, FD-961 forms and/or fingerprint cards should be submitted to BRAG no less than 60 days prior to the applicant’s access approval expiration date.
All requests for expedited SRAs must be sent to FSAP. BRAG should not be contacted.
Responsible Officials can verify updates through eFSAP by checking their APHIS/CDC Form 1 Section 4 table.

If you have any questions regarding this email, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has updated the Chapter 9 – Inspection Module section of the eFSAP Manual and posted the new document to the FSAP website. The updates reflect recent changes to the eFSAP information system.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@cdc.gov.

The Federal Select Agent Program (FSAP), via the CDC Division of Select Agents and Toxin (DSAT), recently received a request for a regulatory interpretation. This interpretation, which has just been posted to the FSAP website, clarifies requirements for the transfer of less than or equal to permissible toxin amounts outlined in 42 CFR §73.3(d)(7) by or to entities registered to possess the toxin.

Read the full regulatory interpretation here.

If you have any questions regarding this email, please contact CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another update to the electronic Federal Select Agent Program (eFSAP) Information System.

Beginning January 31, 2022, eFSAP users will notice the following system updates:

Improved Loading Times and Overall User Experience

- eFSAP is now hosted in a secure cloud environment.
- Users will notice faster page loading times, and a better overall user experience.
- As it is a new environment, you will need to update any saved favorites to the new destination: https://efsap.selectagents.gov.
- If you use the links in the SAMS portal, these will be updated for you.

Implementation of Hybrid Inspections

- Inspection teams are now able to link an initial remote inspection with an on-site follow-up visit.
- Checklist notes, inspector findings, and entity responses from the remote portion are synced with the on-site inspection to flag previously assessed items and eliminate redundancy.

Improved Inspection Document Uploads
- Entity users can now upload documents directly to specific departures and requests for information at the inspection resolution page.

Inspection Finding/Work Objective Associations
- Departures and concerns regarding biosafety requirements now display the specific work objective(s) to which the inspection finding applies.

New “Closed Conditionally” Inspections
- Inspection findings that require no current action to resolve but may require future action to fully close the requirement will be marked “closed conditionally.”
- Inspections will display the status of “closed conditionally” if one or more findings have been closed conditionally.

For more information, please review the tutorial with screenshots of the new features.

Please note: Users must clear their internet browser cache/cookies in order for the system to function properly. Instructions can be found on the eFSAP Resource Center page.

FSAP would like to thank the regulated community for its continued feedback regarding eFSAP system functionality. We look forward to delivering continued improvements based upon your suggestions.

If you experience errors, have questions, or have challenges with access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.

If you have any questions regarding this email, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) has completed the updates to its Federal Select Agent Program Laboratory Examination Tool (FSAP-LET) mobile apps to reflect the program’s updated inspection checklists. As a reminder, FSAP’s updated inspection checklists are now being used for all inspections, as of October 1, 2021, and reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Please visit the FSAP webpage for more information on the mobile apps, or to access a link to download the apps.

We recognize that some organizations are not allowed to self-install applications on Windows devices. For organizations that are part of FSAP, the eFSAP Help Desk can assist your IT staff with being able to load the application using organization-based tools rather than the download from the Microsoft Store. If you require this assistance, please contact us at efsapsupport@cdc.gov.

For PDF versions of the updated inspection checklists, please continue to visit the FSAP Preparing for Inspection webpage.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

Today, the Federal Select Agent Program (FSAP) is announcing the Centers for Disease Control and Prevention’s publication of a Federal Register Notice seeking public comment on a draft policy statement that describes verification requirements for Biosafety Level 4 (BSL-4)/Animal BSL-4 laboratory facilities, including heating, ventilation, and air conditioning (HVAC) systems testing. The requirements are intended to assist individuals and entities in verifying that facility design parameters and operational procedures are functioning as intended to meet the biosafety requirements in the select agent and toxin regulations (42 CFR 73.12(b)).

Comments on the Federal Register Notice should be submitted via the regulations.gov website; more information is available here. Public comments on the policy will be accepted until March 21, 2022.

If you have any questions regarding this email, please contact CDC/DSAT at 404-718-2000 or LRSAT@CDC.gov.

The Federal Bureau of Investigation’s Bioterrorism Risk Assessment Group (BRAG) – which conducts security risk assessments (SRA) for those requesting approval to possess or access select agents and toxins as a part of the Federal Select Agent Program – wants to let the regulated community know that they have recently published a new website for their program, available at https://www.fbi.gov/brag. On this page, you will find information about the SRA process, required forms, and the phone number for the BRAG customer service main line. If you have any questions, please contact BRAG at 304-625-4900.

In fall 2021, the Federal Select Agent Program held two multi-agency public webinars on reporting requirements related to the select agent regulations. During the events, speakers discussed the submission of the APHIS/CDC Form 2, APHIS/CDC Form 3, and APHIS/CDC Form 4, among other topics. The presentations are now available on the FSAP website.

2022 SA Grams