Summary of Federal Laws

 

Environmental Laws                                                

Compliance Partners

Industrial Hygienist/Biosafety Officer

 

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 EA-101 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 CDC Form EA-101, and provide a copy of Form EA-101 to the registering agency.  Penalties for violating this requirement go up to $250,000 per individual and $500,000 per organization.

Resources

Form EA 101: Transfer of Select Agent                      

EA-101 Instructions
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Select Agents and Toxins: What is the Role of The Clinical Laboratory? by Peter Iwen, PhD, Associate Director, NPHL



CFR updated 11/12/2008 RAB
links updated 6/23/08 rab

links updated, resources added, and compliance partner added mlo 2/25/09

Checked Compliance Partners link and updated 05/13/2009 PK