The Catholic University of America

Summary of Federal Laws

Environmental Laws

Public Health Service Laws on Quarantine, Inspection and Licensing of Biological Products

42 U.S.C. § 264 and 42 U.S.C. § 262; 42 C.F.R. Part 72 (interstate shipment of etiologic agents)

Facilities that transfer or receive certain biological agents must be registered. Biological agents include viruses, bacteria, rickettsiae, fungi, toxins, and recombinant organisms/molecules. Prior to transfer of any covered agent, a Center for Disease Control (CDC) Form 1 must be completed for each transfer. In addition, the transferor must verify that the requester's facility has a current registration, verify that the intended use of the agent is correctly indicated on the Form,  and provide a copy of the Form to the registering agency. Penalties for violating this requirement go up to $250,000 per individual and $500,000 per organization. see Enforcement of Select Agent and Toxin Regulations.



Resources


Select Toxin Guidance and Due Diligence: CDC


Select Agents and Toxins: What is the Role of The Clinical Laboratory? by Peter Iwen, PhD, Associate Director, NPHL



updated 8-24-18  mlo