CDC to review inspections rules for labs

The U.S. government does not conduct surprise inspections of laboratories handling the world's most dangerous organisms and poisons, but regulators said Thursday they may change their tactics.

Officials of the Centers For Disease Control and Prevention said they're reviewing the policy, following the failure of inspectors to learn of worker infections last year at Texas A&M University.

"As a rule, we do not do surprise inspections," said Dr. Robbin Weyant, director of Select Agents and Toxins at the CDC. "The issue of unannounced inspections is something we need to consider."

The CDC inspects high-security research laboratories only once every three years, although there are additional inspections when an accident is reported or a lab changes its research.

Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce investigations subcommittee, pointed out that CDC inspectors who visited the Texas A&M lab last year _ shortly after a worker was exposed to Brucella bacteria _ didn't catch the problem.

The lab was required to report the problem to the government immediately, but did not do so until this year.

"Without a surprise inspection, how are you going to know?" Stupak asked.

While CDC inspectors didn't learn of the worker exposure, a watchdog group did. The Sunshine Project, through the Texas open records law, discovered not only the Brucella infection but the exposure of three other workers to the agent that causes Q Fever.

Dr. Richard Besser, the CDC's anti-terrorism coordinator, told the House hearing the agency is looking at ways to improve its inspection program. It may change the composition of inspection teams and increase the frequency of inspections.

The interim president of Texas A&M, Dr. Eddie Davis, said the school was committed "to research, to safety and to compliance." He did not oppose surprise inspections.

"We should have a program that can endure any type of inspection, announced or unannounced," he testified.

Davis said the Sunshine Project's open records request triggered a much more thorough document search than the one sought by the CDC inspectors.

"I assume the CDC didn't do that level of inquiry," Davis said.

"They could have asked us."

The Texas A&M lab has been suspended by the CDC from working with the most dangerous organisms. Davis promised that all problems eventually found by regulators would be fixed before the lab applied to resume the research.

"This is not the type of role model we would like to be," he said, referring to past violations.

Congressional investigators, also testifying at the House hearing, said that unregulated laboratories are experimenting with potentially deadly germs _ increasing public risk in a system that relies on self-reporting of accidents.

Operators of the labs are the only people who know whether a few known cover-ups of accidents "are the tip of the iceberg or the iceberg itself," said Keith Rhodes, a Government Accountability Office expert on lab research.

No government agency knows the total number of unregulated labs or tries to keep track of them, the GAO official said.

The number of labs is expanding, in large part because of an increased counterterrorism effort to develop vaccines and treatments for biological agents that could be used in an attack.

Yet, even the FBI and intelligence agencies are unable to keep track of the proliferating labs, Rhodes said. Only the 409 labs working with at least one of 72 germs and toxins _ designated by the government as "select agents" _ are registered and must report accidents.

Beyond those labs there is "an informational black hole," Rhodes said.

More labs mean "more people who possibly could be compromised ... and the more material you have to move," Rhodes testified.

"The fact that there is so much unknown at the moment, I would have to say there is a greater risk" to the public, he added.

The Associated Press reported this week that American laboratories handling the world's deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing as more labs do the work.

No one died, and regulators said the public was never at risk during these incidents. But the documented cases reflect poorly on procedures and oversight at high-security labs. In some cases, labs have failed to report accidents as required by law.

Lab accidents, ranging from skin cuts to animal bites, result mostly from "human error due to carelessness, inadequate training or poor judgment," Rhodes said.