CDC - Select Agents and Toxins Exemptions: Highly Pathogenic Avian Influenza (Last Reviewed: May 6, 2024)

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Select Agents and Toxins Exemptions:
Highly Pathogenic Avian Influenza


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May 3, 2024

Subject: Highly Pathogenic Avian Influenza Exemption

The Administrator of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has utilized both his discretionary authority and exemption authority under 9 C.F.R. Part 121 to approve temporary modifications to several requirements under the select agent and toxin regulations to support animal and public health preparedness and response efforts following the recent detections of emerging Highly Pathogenic Avian Influenza (HPAI) in livestock.

In accordance with the discretion provided to the APHIS Administrator in 9 C.F.R. § 121.5(a)(1) and (a)(3) and § 121.9, APHIS will temporarily modify specific requirements for a federal laboratory, state and jurisdictional public health laboratories (including wastewater testing laboratories), and healthcare facilities engaged in patient care, as applicable, for a term not to exceed 180 days from the date of this letter, as described below:

1. Time to destroy or transfer samples identified as HPAI is extended from 7 days to 30 days.
2. Time to destroy or transfer samples collected from a patient infected with HPAI upon the conclusion of patient care is extended from 7 days to 30

In addition, the APHIS Administrator determined that the above-mentioned laboratories and facilities have established good cause for exemption from several additional requirements under the select agent and toxin regulations and further determined that such exemption is consistent with protecting animal health and animal products pursuant to 9 C.F.R. § 121.5(f). Specifically, the APHIS Administrator exempts a federal laboratory, state and jurisdictional public health laboratories, and healthcare facilities engaged in patient care, as applicable, from additional requirements in the select agent and toxin regulations listed in 9 C.F.R. Part 121, for a term not to exceed 180 days from the date of this letter, as outlined below:

1. Samples will not be considered HPAI virus in accordance with 9 F.R §121.3(b) until its identification is confirmed by a laboratory designated by the federal government to perform confirmatory testing.
2. Non-negative samples can ship as diagnostic specimens to a lab designated by the federal government to perform confirmatory testing.
3. Waives the requirement of the responsible official to immediately report the identification of HPAI to APHIS’ Emergency and Regulatory Compliance Services (ERCS), Division of Agricultural Select Agents and Toxins (DASAT).
4. Time for reporting positive results of HPAI identification to DASAT on APHIS/CDC Form 4 is extended from 7 days to 30 Laboratories are allowed to batch report all HPAI positive identifications to DASAT every 30 days.
   1. In batch reporting, the submitter is responsible for providing DASAT with the following information:
   2. Confirming identification of HPAI virus;
   3. Compiling a report of final disposition of all HPAI related materials; and
   4. Submitting the report to DASAT every 30 days. The report will include: submitter name, number of samples, sample type, date of identification, final disposition, date of final disposition, and by “Final disposition” means the sample is either retained, destroyed, or transferred.
5. Transfer of positive HPAI samples without the need for completion or submission to DASAT of APHIS/CDC Form 2 to a confirmatory laboratory for further analysis as diagnostic samples and not as select agents. This is also extended to wastewater testing laboratories. However:
   1. Transfers of pure cultures of HPAI virus are not
   2. Transfers of HPAI between FSAP registered entities are not
   3. Transfer of HPAI for purposes other than diagnosis, patient care or HPAI response efforts are not exempted.
6. Time for decontamination or transfer for destruction of waste generated by health care professionals during the delivery of patient care to an individual infected with HPAI upon the conclusion of patient care is extended from 7 days to 30 days.

As previously stated, these modifications to the select agent and toxin regulations are valid for a term not to exceed 180 days. Should there be a need, the APHIS Administrator will consider whether the use of his discretionary authority should be extended or whether he should issue a new exemption. Per 9 C.F.R. § 121.5(f), exemptions for good cause cannot exceed three years.

Please feel free to share this information with all collaborating laboratories. If you have any questions concerning the modifications to the select agent and toxin regulations discussed in this letter, please contact Division of Agricultural Select Agents and Toxins at 301-851-2070 or by email at DASAT@usda.gov.

Sincerely,

Hallie Zimmers
Acting Deputy Administrator
Emergency and Regulatory Compliance Services
Animal and Plant Health Inspection Service

Last Reviewed: May 6, 2024, 09:55 AM
Source: Division of Regulatory Science and Compliance​

https://www.selectagents.gov/sat/exemptions/avian-influenza.htm