OMB Approves APHIS Toxin List Update Final Rule

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a final rule from the USDA’s Animal and Plant Health Inspection Service (APHIS) on “Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List”. The advanced notice of proposed rulemaking was published on March 17^th, 2020. The notice of proposed rulemaking was published on January 30^th, 2024.

According to the Spring 2024 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. On April 8, 2022, APHIS sent tribal nations a letter outlining the provisions of the proposed rule and soliciting their feedback. On May 5, 2022, the Sac and Fox Tribe of the Mississippi in Iowa submitted a response expressing concerns regarding whether possible Brucella abortus delisting would materially adversely impact APHIS' domestic quarantine program for the control and eradication of brucellosis in cattle and bison. In response, APHIS clarified that the two issues were distinct, and no adverse operational impacts were anticipated. On June 6, 2022, the Tribe indicated that they had no further comments or concerns.”

In January the HHS’ Center for Disease Control and Prevention (CDC) published their NPRM for a similar update of regulations and lists for select agents/toxins. These two rules are typically published in tandem and the final rules for both were sent to OIRA on October 3^rd, 2024. I suspect that we will see OIRA approve the CDC final rule early this coming week.

These are coordinated rulemakings. The APHIS rule targets the protection of animals, live stock in particular. The CDC’s rule targets the protection of humans. This means that there is some degree of overlap between the two sets of lists and regulations.

I will probably publish a single post covering both rules when they are published.