Bioscope ‘08

by  Dr. Barbara Price

US Biodefense Labs' Fines

          Texas A&M University has agreed to pay a $1 million fine to the U.S. Department of Health and Humans Services for safety failures at its biodefense laboratories (February, 2008). The university will pay the fine with research-compliance dollars. The CDC investigated the operation of the laboratories in July 2007 and took away the certification that permitted the university at Texas A&M to operate with select agents. A 2003 regulation requires that labs using select agents register with the CDC and undergo inspections and most of the inspections have centered on facilities and equipment, not necessarily operating procedures. An inspection at Texas A&M in February 2006 found only minor problems, such as variations in tracking lab inventory, which is an operating procedure.

          Will and should the fines paid to the DHHS pay for the inspections the CDC performs for laboratories using select agents? Who pays for the inspections of the Office of the Inspector General of DHHS? This office set the fine after a separate inspection. If Texas A&M uses its "research-compliance dollars", what funds will they use to become compliant and stay compliant? How much do the inspections (including the GAO inspection), and the preparations for them, add to the overall cost of the biodefense laboratory program?

          What did Texas A&M do? The university administrators did not report infections and exposures to dangerous agents to the CDC according to the safety standards. Several researchers were exposed to Brucella and Q fever, one researcher became ill. They did not report several missing vials of Brucella and at least seven cases of unauthorized access to select agents. In several cases the agents and exposed animals were not stored correctly and the security plans, training procedures and record keeping were inadequate.

          In October 2007, the federal government levied a $450,000 fine on the University of California after a Lawrence Livermore National Laboratory scientist sent an uninspected package containing two unsealed vials of the deadly pathogen anthrax across the country and the vials leaked. In 2006, the University of South Carolina agreed to pay $50,000 in fines for failing to maintain training and inspection records and for having inadequate security, biosafety, and incident-response plans.

          Since the start of the select agent program, 105 possible exposures and losses have been reported to CDC and the Office of the Inspector General to the US DHHS [Science, 2007]. Perhaps the country would have been better off with a few less laboratories, but ones that could meet the requirements for working with select agents. Are other countries operating on a safer basis? Probably not.

For the Professional in Government and Industry with an interest in Nuclear, Biological and Chemical Defense, Disarmament and Verification; Emergency and Disaster Medical Planning; Industrial Health and Safety; and Environmental Protection