2023 SA Grams

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.

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.

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.

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.