Bioterrorism Rule Updates Sent to OMB

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received two notices of proposed rulemakings (NPRMs) supporting biennial updates required by the bioterrorism acts. NPRMs were received from Agriculture Department’s Animal and Plant Health Inspection Service (APHIS) the CDC.

According to the Spring 2023 Unified Agenda entry for the APHIS 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.”

According to the Spring 2023 Unified Agenda entry for the CDC 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.”