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CDC Tightens Oversight on Labs Capable of Fueling Bioterrorism

By David Wahlberg

Cox News Service -- ATLANTA

So many labs across the country store dangerous germs that could be used for bioterrorism -- 414 at last count -- that the Centers for Disease Control and Prevention is requiring they register and submit to inspections and security clearances.

“Up until this rule, we had no idea who possessed all these agents in the United States,” said Mike Sage, deputy director of the Atlanta-based CDC’s Office of Terrorism and Emergency Response. “Historically, you just put it on a UPS truck and sent it.”

While some researchers say they understand the need for tighter security, others claim the new regulations are interfering with studies on developing drugs and vaccines to respond to bioterrorism.

Some cite the indictment of a Texas Tech researcher who goes on trial Monday on charges he mishandled plague samples as reason for concern.

CDC officials say the rules, mandated by the 2002 Patriot Act and a separate public health security law, aim to avoid problems like those that arose during the 2001 anthrax attacks: confusion over where anthrax is stored and who has access to it.

“The goal is to help deter the potential use of these agents or the release of these agents, which could harm human health,” Sage said.

Under the rules, labs that keep any of a list of 49 biological agents considered dangerous to humans must register with the CDC by Nov. 12. So far, 414 universities, government agencies, businesses and research foundations have signed up.

The CDC won’t release the list of labs, saying it would pose a threat to national security.

Labs that use 33 other agents considered harmful to animals and plants must register with the U.S. Department of Agriculture, which will inspect the labs.

Both agencies are required to inspect each lab at least every three years. Laboratory workers -- including scientists, students and secretaries -- must undergo FBI background checks.

The CDC’s list of germs includes anthrax, ricin, smallpox and botulinum toxin, as well as lesser-known pathogens such as the Lassa and Marburg viruses, which can rapidly cause severe bleeding and organ failure.

CDC previously had a list of labs that transported agents, but didn’t require notice of when each sample was shipped and who was responsible, Sage said.

The rules also didn’t apply to storage of the germs.

Nearly half of the newly registered labs have been inspected. The searches have revealed some shortcomings, including inadequate security plans and the need for better door locks, CDC officials said.

Making all lab workers clear FBI background checks led biologist Daniel Portnoy of the University of California, Berkeley, to destroy his bubonic plague samples.

He said he’s one less scientist who may have helped develop countermeasures for the disease.

“I work in a lab where there are undergraduates, rotating students and people coming in for office hours,” Portnoy said. “Completely eliminating any access to the lab would have been too difficult.”

Some researchers at Emory University in Atlanta have also discarded samples instead of facing increased scrutiny and paperwork, said Kristin West, director of Emory’s Office of Research Compliance. She would not identify the researchers.