2022 SA Grams

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.

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:

1. 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.

1. 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

1. 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
2. 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

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.

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.

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.