Which organizations maintain Tier 1 agent/toxin lists that have enforceable regulations attached to them?

• A. CDC and NIH
• B. USDA and CDC
• C. EPA and FDA
• D. NIH and FDA

Answer: (B)

The main idea is that the most dangerous biological agents and toxins are governed by the Federal Select Agent Program, which is run jointly by the Centers for Disease Control and Prevention and the USDA’s Animal and Plant Health Inspection Service. They maintain the lists of Select Agents and Toxins, including the Tier 1 subset, and these items have enforceable regulations attached. Those regulations require facilities to be registered, implement strict security measures, conduct personnel background checks for anyone with access, maintain precise inventories, report incidents, and ensure robust biosafety training. Other agencies such as EPA or FDA oversee different regulatory areas and do not maintain these Tier 1 lists with FSAR-level enforcement. NIH is a research funder and does not administer these enforcement rules. So the responsible pair is CDC and USDA.