2023 SA Grams

Today, the Federal Select Agent Program (FSAP) published its eighth annual report of aggregate program data, the 2022 Annual Report of the Federal Select Agent Program.  The report summarizes data for calendar year 2022 and is part of FSAP’s continued efforts to provide the American public with insight into the regulatory activities of the program.

Once again, 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.  The report also highlights FSAP’s efforts to engage with the regulated community throughout the year to enhance regulatory compliance.

As in previous years, data from this year’s report underscore that overall, 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 health or agriculture.

In addition, FSAP is pleased to note that this year marks the 20^th anniversary of the Federal Select Agent Program – two decades of the program providing critical leadership in the areas of biosafety and security.  With the oversight provided by FSAP during this time, laboratories have been able to continue to work with dangerous biological agents and toxins in a safe and secure manner.

The report also reflects the program’s ongoing commitment to transparency.

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

To ensure that entities are complying with the requirements of the select agent and toxin regulations, the Federal Select Agent Program (FSAP) inspects entities using standardized checklists to verify that laboratories have the appropriate safety and security measures in place.  We wish to inform you that FSAP has recently added new, and updated existing, inspection checklists. Please find the new/updated checklists on the FSAP website here.

The following new checklists have been added:

• ABSL-3 Ag Laboratories
• Agent Specific: ASFV, CSFV
• Agent Specific: Avian Influenza Virus
• Agent Specific: FMD and Rinderpest Additional Security
• Agent Specific: Newcastle Disease Virus
• Agent Specific: Rinderpest
• Agent Specific: VEEV, RVFV
• Agent Specific: 1918 Influenza, Poxvirus, RVFV, SARS-CoV, VEEV
• Registration and Restricted Experiments

The following checklists have been updated:

• Biocontainment: Plant Containment Laboratories
• General Biocontainment
• General Biosafety
• Security

Please note the above checklists are in the process of being updated on the FSAP Laboratory Examination Tool (FSAP-LET) App. A notification will be sent once this is complete.

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

Effective October 1, the CDC’s Division of Select Agents and Toxins (DSAT) will be known as the Division of Regulatory Science and Compliance (DRSC).

While the Division’s name is changing, its regulatory authority has not.  DRSC will continue to implement the same regulatory programs – including the Federal Select Agent Program and the Import Permit Program.

The Division will continue to develop and implement U.S. Federal regulations for compliance to help enhance biosafety and security in laboratory science that can lead to improved detection, prevention, diagnostic, and treatment options for some of the most deadly diseases impacting public health.

We would like to make the regulated community aware of this change and assure you that this organizational change will not affect the division’s regulatory oversight.

Please note that our materials and website are currently in the process of being updated to reflect these changes.

If you have any questions, please feel free to contact us at LRSAT@cdc.gov or 404-718-2000.

The Federal Select Agent Program (FSAP) is informing all federal entities of a new Congressional notification requirement for any events/incidents at federal laboratory facilities involving the theft, loss, or release of select agents or toxins. In accordance with Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (42 USC 262a(k)(1); Public Law 117-328), effective December 29, 2022, the Centers for Disease Control and Prevention’s Division of Select Agents and Toxins (DSAT) is required to notify Congress of all select agent and toxin theft, loss, or release (TLR) events at federal laboratory facilities. Specifically, the statute requires that DSAT:

(A) not later than 72 hours after such event is reported to the Secretary, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives of such event, including–

    (i) the Federal laboratory facility in which such release, loss, or theft occurred; and

    (ii) the circumstances of such release, loss, or theft; and

(B) not later than 14 days after such notification, update such Committees on–

   (i) any actions taken or planned by the Secretary to mitigate any potential threat such release, loss, or

    theft may pose to public health and safety; and

    (ii) any actions taken or planned by the Secretary to review the circumstances of such release, loss, or

    theft, and prevent similar events.

Congress established the new requirement for DSAT with the intent of enhancing transparency, oversight, and accountability in managing select agents and toxins, and to ensure swift and appropriate measures are taken to safeguard public health and safety.

DSAT, with the Animal and Plant Health Inspection Service (APHIS) Division of Agricultural Select Agents and Toxins (DASAT) voluntary cooperation, will provide the required notifications by using information from the APHIS/CDC Form 3 (Report of a Release/Loss/Theft) submitted by federal entities.  DSAT plans to begin submitting the required reports to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives in the coming weeks. The first report will include all prior APHIS/CDC Form 3 reports of thefts, losses, or releases from federal entities since December 29, 2022, the effective date of the new requirement.

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

On October 4, 2022, in accordance with the HHS Select Agent and Toxin Regulations, 42 C.F.R. § 73.5(a)(4)(iii), the Division of Select Agents and Toxins (DSAT) authorized less stringent reporting requirements for the identification of Mpox virus due to the 2022 Mpox Outbreak. This less stringent reporting allowed clinical and diagnostic laboratories and other entities that possess the HHS select agent to submit one consolidated report, using the APHIS/CDC Form 4, to report all identifications of Mpox virus for a 180-day period.

Today, on August 31, 2023, the Centers for Disease Control and Prevention (CDC) ended their public health response to the 2022 Mpox Outbreak, thereby marking the conclusion of the outbreak as determined by the CDC. Therefore, beginning on October 30, 2023, clinical and diagnostic laboratories and other entities are no longer allowed less stringent reporting for the identification of Mpox virus. Please note that an APHIS/CDC Form 4 must be submitted within seven calendar days after identification of Mpox virus. See 42 C.F.R. § 73.5(a)(4) and § 73.9(c)(2).

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

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

CDC/DSAT highly recommends that entities maintaining materials after completion of diagnostic procedures or for research purposes clearly label samples with the appropriate clade determination in case there are any future questions on regulatory status of possessed material. Separation of 2022 U.S. Mpox Outbreak samples from confirmed regulated strains of Congo Basin clade (Clade 1) is also recommended to prevent uncertainty in the inventory and cross contamination.

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

Today, August 10, 2023, the Centers for Disease Control and Prevention (CDC) published a Federal Register Notice regarding Coxiella burnetii Phase II, Nine Mile Strain, plaque purified clone 4 with reversion to wildtype cbu0533.  The CDC has determined that an excluded attenuated strain, Coxiella burnetii Phase II, Nine Mile Strain, plaque purified clone 4, has, in one instance, been shown to spontaneously mutate when passaged in vivo. The resulting mutant, C. burnetii Phase II, Nine Mile Strain, plaque purified clone 4 with reversion to wildtype cbu0533, has enhanced pathogenicity and virulence.  Therefore, C. burnetii Phase II, Nine Mile Strain, plaque purified clone 4 with reversion to wildtype cbu0533 IS NOT an excluded strain but IS a select agent and therefore subject to the select agent and toxin regulations. More information is available here.

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

Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its fifth annual joint-program analysis of inspection report timeliness data, the 2022 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 100% of final inspection reports sent to entities in 2022 within the program’s goal of 30 business days.

Key findings include the following:

• FSAP issued 198 final inspection reports in 2022, with 100% of those reports on time.
• The average time to issue a final report was 17 days.
• FSAP issued 1 immediate action observation, also within the target timeframe of 10 business days.

These data reflect the sixth consecutive year for CDC’s Division of Select Agents and Toxins, and the fourth consecutive year for APHIS’ Division of Agricultural Select Agents and Toxins, in which at least 95% of final inspection reports were issued on time.  While the program is pleased by these results, FSAP will continue to track and analyze this data to ensure that entities receive timely feedback and to identify any necessary opportunities for improvement.

For more information, please see the full report, available here.

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) would like to provide a reminder of the regulations that apply when manipulating excluded attenuated strains of select agents and modified toxins.  While some attenuated strains of select agents and modified toxins may be excluded due to their low virulence or toxic activity, it is important to note that this material may be subject to the select agent and toxin regulations if it is manipulated and virulence or toxic activity is restored or enhanced.

The regulations provide that “[i]f an excluded attenuated strain or modified toxin is subjected to any manipulation that restores or enhances its virulence or toxic activity, the resulting select agent or toxin will be subject to the requirements of this part” [42 CFR 73.3(e)(2), 42 CFR 73.4(e)(2), 9 CFR 121.3(e)(2), 9 CFR 121.4(e)(2), and 7 CFR 331.3(e)(2)]. Therefore, an excluded attenuated select agent strain or modified toxin will be subject to the regulations if there is a reintroduction of factor(s) associated with virulence, toxic activity, or other manipulations that modify the attenuation such that virulence or toxic activity is restored or enhanced.

If an excluded attenuated strain of a select agent is manipulated to restore or enhance its virulence, it is subject to the select agent and toxin regulations. This means that the entity working with the manipulated attenuated select agent strain must be registered with FSAP, and any activities involving the manipulated attenuated select agent strain must be conducted in compliance with the select agent and toxin regulations.

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.

In 2022, the Federal Select Agent Program (FSAP) held a series of six webinars for Responsible Officials and Alternate Responsible Officials.  Each webinar was designed to provide participants with information related to compliance with the select agent regulations, as well as updates from FSAP on a variety of topics.

The webinar presentations have been posted to the FSAP website and are now available for download here.

Today, the Federal Select Agent Program (FSAP) is announcing the Centers for Disease Control and Prevention (CDC)’s publication of a Final Rule in the Federal Register regarding the addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses to the HHS list of Select Agents and Toxins.

The Final Rule states that HHS/CDC has amended the select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. HHS/CDC also requires regulated entities to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.

No changes were made to the regulatory requirements in the Interim Final Rule as a result of public comments received; however, CDC has developed the Guidance on the Regulation of SARS-CoV/SARS-CoV-2 Chimeric Viruses and Frequently Asked Questions to help entities comply with the regulations.

If you have any questions regarding this email, please contact 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 the Notice of Availability in the Federal Register for the Policy Statement for Biosafety Level 4 (BSL-4)/Animal Biosafety Level 4 (ABSL-4) Laboratory Facility Verification.  The policy statement assists 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)).

A draft version of this policy was published in the Federal Register on January 19, 2022 for public comment. All comments were taken into account during the finalization of the policy; as a result of comments received, clarification was added to address HVAC operational verification, examples of major changes to the HVAC system, and what BSL-4/ABSL-4 facility verification entails and how often and when it should be performed. A full summary of the comments and responses can be reviewed in the Federal Register Notice.

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

On October 4, 2022, in accordance with the HHS Select Agent and Toxin Regulations, 42 C.F.R. § 73.5 (a)(4)(iii), the Division of Select Agents and Toxins (DSAT) authorized less stringent reporting requirements for the identification of Monkeypox (Mpox*) virus due to the 2022 Mpox Outbreak. This less stringent reporting allows clinical and diagnostic laboratories and other entities that possess the HHS select agent to submit one consolidated report, using the APHIS/CDC Form 4, to report all identifications of Mpox virus for a 180-day period:

Until the conclusion of the Mpox virus outbreak as determined by the Centers for Disease Control and Prevention (CDC), 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 Mpox virus for a 180-day period. All Mpox virus positive samples, not characterized to clade level or identified as Clade I of the Mpox 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 that because the Mpox virus outbreak is still ongoing, DSAT is continuing to authorize this less stringent reporting requirement. The 180-day reporting period should be utilized on a continual or rolling basis until the end of the 2022 Mpox Outbreak, as determined by the CDC. For example, if an entity identifies an Mpox virus positive sample on October 4, 2022, the entity will have 180-days from that date to report this identification and may do so in a consolidated report, to report all Mpox virus samples identified during the 180-day time period. Likewise, if an entity identifies a Mpox virus positive sample today, the entity will have 180-days from today to report this positive sample and may do so in a consolidated report.

As a reminder, Clade II (West African Clade) Mpox virus is excluded from the select agent and toxin regulatory requirements, including identification reporting. Therefore, samples that have been identified to be or contain Clade II (West African Clade) Mpox virus, do not need to be reported to DSAT. However, all identifications of Mpox virus, clade undetermined, or Clade I (Congo Basin Clade) Mpox virus must be reported to DSAT using an APHIS/CDC Form 4 report.

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

DSAT will continue to review the status of the 2022 Mpox Outbreak and reporting requirements and communicate information to entities.

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

*The World Health Organization recently recommended the nomenclature for Monkeypox virus be changed to Mpox virus. Details of this decision can be found here.