OMB Approved Bioterrorism NPRMs – 1-5-24

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a notice of proposed rulemaking (NPRM) from the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) for “Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List”. The NPRM was sent to OIRA on July 26^th, 2023.

According to the Fall 2023 Unified Agenda entry for this rulemaking:

“In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are proposing to amend and republish the select agent and toxin lists that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action would implement findings of biennial review of the lists. In addition, we are proposing to codify operational procedures and policies necessary to enforce the regulations. This action was vetted with Tribal nations, and APHIS has subsequent conversations with one Tribal nation in order to ensure the provisions would not adversely affect them.”

A companion rulemaking sent to OIRA on the same day from HHS’s Centers for Disease Control and Prevention (CDC) on “Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review” was also approved by OIRA.

According to the latest Unified Agenda entry for that rulemaking:

“The Bioterrorism Preparedness Act requires that the Department of Health and Human Services (HHS) Secretary review and republish the list of select agents and toxins on at least a biennial basis. This document begins the biennial review and republication of the list of biological agents and toxins regulated by HHS.”

These two NPRM’s will almost certainly be published in the Federal Register on the same day, probably in the coming week.