LLNL Statement on DHHS Notice of Violation

October 5, 2007 -- Lawrence Livermore National Laboratory has reached a $450,000 settlement agreement with the U.S. Department of Health and Human Services, Office of the Inspector General (OIG). The agreement concerns violations of the Centers for Disease Control’s (CDC) select agent regulations and involves errors in two shipments of bacillus anthracis dating back to September 2005.

In this particular situation, LLNL sent a shipment that had been inappropriately packaged and another shipment with incorrect paperwork. Upon discovery, we voluntarily suspended all select agent research for seven months and took aggressive action to correct the issues. We conducted an extensive review to ensure that new procedures, processes and training now preclude the acknowledged errors and that our practices effectively protect both our personnel and the general public.

Subsequently, the Centers for Disease Control (CDC) issued our laboratory a three-year renewal of its select agent registration — without restriction. This renewal came in April 2006 following a CDC inspection of LLNL policies, practices and procedures. The registration allows our laboratory to continue necessary research on behalf of the nation. We have conducted research and worked with biological level agents since the 1960’s and level 2 select agents since 2000.

Best management practices involving the use of select agents and the safety, protection and consideration of our employees and the general public is and will continue to be a top priority at our laboratory.

Source: Lawrence Livermore National Laboratory

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