Anthrax error in 2004 revealed lab problems
The Birmingham News
DAVE PARKS, News staff writer
An anthrax mistake two years involving Southern Research Institute revealed gaps in the nation's system of regulating labs, and an activist organization says a comprehensive lab safety law is badly needed.
The problem occurred in 2004 when Southern Research's lab in Frederick, Md., shipped anthrax spores that were supposed to be inactivated to Children's Hospital Oakland Research Institute in California for vaccine studies.
Lab animals started dying, and scientists found that the spores were still active. Nobody became ill, but the mistake sparked an investigation by the Centers for Disease Control.
The CDC found a flaw in the process used by lab workers in Frederick to inactivate anthrax spores. And they found that lab workers in Frederick failed to test cultures to ensure that the anthrax was deactivated.
Debra Sharpe, safety and security manager for Southern Research, said the process has been corrected, and safety oversight has been increased.
Procedures for inactivating anthrax or any other pathogens are now reviewed by the company's institutional biosafety committee, which oversees labs in Birmingham and Frederick, and by the CDC, she said.
But there are no laws requiring such oversight, Sharpe said. Institutional biosafety committees, which are supposed to be a cornerstone of lab safety, grew years ago out of concern about genetic engineering. They are based upon guidelines from the National Institutes of Health, which require that these committees oversee government-funded research involving recombinant DNA technology.
But the committees are not required to oversee other research, including so-called "dual use" research - legitimate scientific work with agents such as anthrax that could be misused. A government committee, the National Science Advisory Board for Biosecurity, has been meeting on the issue.
Edward Hammond, director of the U.S. office of the activist organization Sunshine Project, said the Board for Biosecurity is moving too slowly, and the nation needs stronger laws regulating lab safety, something that is being resisted by many scientists.
"We have a sort of fuzzy system," he said.
There are too many vague regulations and too much secrecy surrounding research into bioterror agents, Hammond said. Taxpayers are spending billions of dollars for this research, he said, and they have a right to know what's being done and the dangers to the community.
The CDC refuses to release specific information about which labs are performing this sensitive research. The information is exempt from the Freedom of Information Act, said Von Roebuck, a CDC spokesman. "It's a security measure."
Under NIH guidelines, minutes from institutional biosafety committee meetings are public information. But Southern Research and other labs have determined that only minutes involving recombinant DNA technology have to be made public.
Sharpe said there is no law or guideline requiring full disclosure, and minutes pertaining to bioterror research include proprietary information.
Sharpe said Southern Research is open about the kind of work it's doing.
"I don't want some black cloak around what we do," she said. "We don't feel like we have anything to hide."
Sharpe agreed that a comprehensive lab safety law would clarify things, but it would be controversial. "I think it's a lot of control and a lot of Big Brother, but I believe we ought to do that."
DAVE PARKS, News staff writer
An anthrax mistake two years involving Southern Research Institute revealed gaps in the nation's system of regulating labs, and an activist organization says a comprehensive lab safety law is badly needed.
The problem occurred in 2004 when Southern Research's lab in Frederick, Md., shipped anthrax spores that were supposed to be inactivated to Children's Hospital Oakland Research Institute in California for vaccine studies.
Lab animals started dying, and scientists found that the spores were still active. Nobody became ill, but the mistake sparked an investigation by the Centers for Disease Control.
The CDC found a flaw in the process used by lab workers in Frederick to inactivate anthrax spores. And they found that lab workers in Frederick failed to test cultures to ensure that the anthrax was deactivated.
Debra Sharpe, safety and security manager for Southern Research, said the process has been corrected, and safety oversight has been increased.
Procedures for inactivating anthrax or any other pathogens are now reviewed by the company's institutional biosafety committee, which oversees labs in Birmingham and Frederick, and by the CDC, she said.
But there are no laws requiring such oversight, Sharpe said. Institutional biosafety committees, which are supposed to be a cornerstone of lab safety, grew years ago out of concern about genetic engineering. They are based upon guidelines from the National Institutes of Health, which require that these committees oversee government-funded research involving recombinant DNA technology.
But the committees are not required to oversee other research, including so-called "dual use" research - legitimate scientific work with agents such as anthrax that could be misused. A government committee, the National Science Advisory Board for Biosecurity, has been meeting on the issue.
Edward Hammond, director of the U.S. office of the activist organization Sunshine Project, said the Board for Biosecurity is moving too slowly, and the nation needs stronger laws regulating lab safety, something that is being resisted by many scientists.
"We have a sort of fuzzy system," he said.
There are too many vague regulations and too much secrecy surrounding research into bioterror agents, Hammond said. Taxpayers are spending billions of dollars for this research, he said, and they have a right to know what's being done and the dangers to the community.
The CDC refuses to release specific information about which labs are performing this sensitive research. The information is exempt from the Freedom of Information Act, said Von Roebuck, a CDC spokesman. "It's a security measure."
Under NIH guidelines, minutes from institutional biosafety committee meetings are public information. But Southern Research and other labs have determined that only minutes involving recombinant DNA technology have to be made public.
Sharpe said there is no law or guideline requiring full disclosure, and minutes pertaining to bioterror research include proprietary information.
Sharpe said Southern Research is open about the kind of work it's doing.
"I don't want some black cloak around what we do," she said. "We don't feel like we have anything to hide."
Sharpe agreed that a comprehensive lab safety law would clarify things, but it would be controversial. "I think it's a lot of control and a lot of Big Brother, but I believe we ought to do that."
