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Thursday, October 11, 2007  
Lab Fined $450,000 for Anthrax Incident

By: Independent Staff
Published In: The Livermore Independent

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.

It was the largest fine levied in recent history by the federal Department of Health and Human Services (DHHS).

Tri-Valley CAREs has submitted a Freedom of Information Act (FOIA) requests to federal agencies seeking details about an anthrax accident at the facility.

The fine against the University of California, as the Livermore Lab?s manager, was made public last week, October 4, 2007, while the House Energy and Commerce Committee held the first ever congressional hearing on the safety and security of the Nation?s biodefense research laboratories.

The Department of Health Office of Inspector General (OIG) specifically alleged that the Lab violated the transfer requirements of the select agent regulations by failing to comply with the applicable shipping and packaging laws when transferring a select agent. In addition, the OIG alleged that LLNL failed to comply with security and access requirements by allowing an individual not authorized to have access to select agents to package the shipments of anthrax, and that LLNL?s responsible official failed to ensure compliance with the shipping and packaging requirements of the select agent regulations.

Under the terms of the settlement, LLNL agreed to pay the OIG $450,000 to resolve these allegations.

According to a statement issued by the Lab, ?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.?

The statement noted that the Centers for Disease Control (CDC) issued the Lab 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 the Lab to continue research.

Marylia Kelley, the Executive Director of Tri-Valley CAREs who lives across the street from Livermore Lab, responded: ?I am angry that the University of California Regents and Livermore Lab officials deliberately withheld important information from the public.?

The FOIA requests are viewed as important by Tri-Valley CAREs, because very little is currently known about the violations that resulted in the anthrax release. Kelley added, ?We know that the DHHS has determined that anthrax was released, and that employees who opened the shipment were put on Cipro due to their potential exposures. We believe Livermore Lab?s response is not sufficient to protect the public from future mishaps. Serious questions remain.?

Robert Schwartz, Staff Attorney at Tri-Valley CAREs, added, ?I am particularly troubled that Livermore Lab allowed an unauthorized individual to package a biowarfare agent. This not only violates government regulations but raises the specter that Livermore Lab?s handling of dangerous biological agents may increase the risk that a terrorist could access anthrax at the Lab and spread it around the community.

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