APHIS and CDC send Bio-Toxin Final Rules to OMB

Yesterday, OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received final rules from USDA’s Animal & Plant Inspection Service (APHIS) and the CDC relating to the updating of the Select Agent and Toxin List. These are coordinated rulemakings.

APHIS Final Rule

The APHIS final rule notice is on “Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List”. 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.”

CDC Final Rule

The CDC final rule notice is on “Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review”. The notice of proposed rulemaking was published on January 30^th, 2024.

According to the Spring 2024 Unified Agenda entry for this 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 final rule concludes the biennial review and republication of the list of biological agents and toxins regulated by HHS.”