2023 SA Grams

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.