CDC Select Agent

Federal Select Agent Program Annual Reports 2017-2024

The Federal Select Agent Program publishes annual reports covering select agent and toxin regulations, incident data, and laboratory oversight. The 2024 Annual Report was released September 10, 2025, alongside a 2024 Inspection Report Processing Annual Summary released August 20, 2025. The publication index also includes inspection summaries from 2015–2023 and peer-reviewed journal articles on biosafety and select agent program compliance.

Five Select Agents Removed From Regulated List Effective January 16, 2025

HHS and USDA published parallel Final Rules on December 17, 2024 removing five select agents from the regulated list effective January 16, 2025. The removed agents include three Brucella species (B. abortus, B. melitensis, B. suis), African horse sickness virus, and Peronosclerospora philippinensis. The rules also update nomenclature for Ebola and SARS-CoV viruses, designate Nipah virus as Tier 1, and increase the conotoxin exclusion threshold from 100 mg to 200 mg.

Annual Inspection, Biosafety Plan, Drills Guidance

CDC Division of Select Agent and Toxins publishes a comprehensive index of guidance documents for select agent and toxin compliance. The guidance covers annual inspections, biosafety/biocontainment plans, drills and exercises, incident response, security planning, training requirements, and suitability assessments for entities handling select agents and toxins.