Laboratory Biosafety Regulation – Select Agents      

Since September 11, 2001, two major pieces of legislation, the USA PATRIOT Act of  2001 and the “Public Health Security and Bioterrorism Preparedness Act of 2002” have changed the law governing the possession, use, and transport of etiologic agents.  Following is a summary of key points most relevant to you as researchers.

A current list of select agents and other updates may be found at the CDC Office of the Director Select Agent Program website, http://www.cdc.gov/od/sap/index.htm.

Please contact Wayne Brannan, Director, University Risk Management, who is the MUSC Responsible Official if you have any questions regarding select agent registration, security, or transfer of select agents.

• HHS will:
• be more aggressive in maintaining a current select agent list
• expand regulations to include those governing possession and use in addition to previous ones regulating transfer of select agents
• include safeguard and security provisions in their select agents regulations
• have the authority to conduct inspections re:  access to select agents
• exempt specific products that are, contain, or bear a select agent from the regulations

• Individuals must:
• register possession, use, or transfer of select agents
• undergo a background check to obtain access to select agents
• restrict access to select agents to registered individuals with a “legitimate need”
• provide the Department of Justice with the identity of individuals seeking access to select agents.  The Department is responsible for background checks.
• promptly notify the proper authorities if select agents are released outside the biocontainment area or if they are stolen or lost

PENALTIES FOR FAILURE TO COMPLY: 

• Civil penalties for violating the regulations may amount to $250,000 for an individual.
• Criminal penalties include a fine or imprisonment up to five years for possession without registration or transfer of a select agent to an unregistered individual.