2022 SA Grams
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.
- (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:
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 icon[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 icon[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 Manualpdf icon 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
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- 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.govexternal icon.
- If you use the links in the SAMS portal, these will be updated for you.
- Implementation of Hybrid Inspections
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- 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 tutorialpdf icon 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 Centerpdf iconexternal icon 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 formexternal icon, 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)external icon 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 Noticeexternal icon 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 hereexternal icon. 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/bragexternal icon. 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.