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Feds scramble to list bioterror holdings

By STEVE MITCHELL, UPI Medical Correspondent

WASHINGTON, Aug. 13 (UPI) -- The federal government is frantically trying to track down which U.S. labs have potential bioterror pathogens in time to meet the September deadline set by a new law, but experts on biological agents said the measure will do little to prevent a person with devious intentions from fraudulently obtaining the lethal agents.

Driving the new requirement is the federal government's lack of knowledge about which labs are working with potential bioweapons. This came to light during the FBI's investigation of the anthrax mailings when the bureau, which believes the anthrax originated from a domestic source, acknowledged it had no way of knowing which labs across the country may have been dealing with the deadly agent.

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The new law, part of the Public Health Security and Bioterrorism Preparedness and Response Act, is aimed at setting up a database of government and private labs working with biological agents that pose a threat to humans, animals or plants. The Centers for Disease Control and Prevention in Atlanta, which is heading up the effort, has mailed forms to 190,000 facilities requesting information on the biological agents they are using or studying.

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The facilities are required to respond by Sept. 10. Those failing to respond face prison time of up to five years and fines up to $250,000.

At present, the government is concerned about 36 biological agents, including smallpox, anthrax and Ebola.

"Most of these agents require significant levels of biocontainment or could cause significant illnesses and mass casualties," Stephen Ostroff, acting director of the CDC's National Center of Infectious Diseases, told United Press International.

"All 36 are potential bioterrorist agents, the most dangerous pathogens known to humankind (with some) history of having been weaponized in the past," Janet Shoemaker, director of public and scientific affairs at the American Society for Microbiology, which is working with the CDC to implement the guidelines, told UPI.

At present there is no database of labs working with these deadly agents, Ostroff said. "We won't know how many of (the 190,000) facilities do possess these agents until we receive all of those forms back.

"Laboratories transporting deadly agents between states have been required to register with the CDC and there may be 250 such labs based on those records, Shoemaker said.

"You wouldn't have to register if you didn't transfer it, so there could be more," she noted.

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"If the records of transfer truly represented records of who had the material, then the FBI would have had a better handle on which labs were likely of having anthrax," said Stephen Prior, a bioterrorism expert at the Arlington, Va.-based think tank Potomac Institute for Policy Studies.

Prior noted that the bureau "went on record as saying they had no indication of how many labs had the material."

Ed Curlett, spokesman for the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, which is responsible for tracking down labs working with biological agents of threat to agriculture, told UPI that records of interstate movement gives APHIS an accurate account of such labs.

"We do know pretty much who has what because they would've had to have gotten a permit from us to get it in the first place," he said, regarding agriculturally related pathogens.

Henry Miller, a bioterrorism expert at the Hoover Institution at Stanford University and the founding director of the FDA's Office of Biotechnology, said, "The CDC doesn't have any idea" which labs are working with these agents.

Miller said the new law is "more a public policy fig leaf than it is a genuine mechanism for protecting us." He also said it is not cost-effective, noting that it comes at a substantial cost -- about $5 million per year.

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There are "so many gaps here that it's almost nothing," he said.

Miller noted that although labs are required to report the most lethal bioweapons, they do not have to report other potentially dangerous organisms like salmonella and E. coli. He pointed out that salmonella was used as a bioterrorist weapon in Oregon in 1984, when members of the Rajneeshee cult sprayed the bacteria in several salad bars. More than 700 people became ill, but no one died from the attack.

In addition, you can easily obtain some of these agents from nature, he said, noting that anthrax, salmonella and E. coli are ubiquitous in the environment. "We're never 100 percent safe from these things. They're out there," he said.

Prior said he doubted the law would "provide the degree of protection everybody is expecting."

CDC's Ostroff disagreed, saying, "It certainly will have a deterrent effect ... Will it absolutely deter every potential scenario one could imagine? I don't think you could write a law that would do something like that."

Despite the law's shortcomings, Prior called it a "very important exercise," because "it will give an idea of the extent of what's out there and it will increase awareness that there is a responsibility not to widely disseminate these agents."

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One concern is that some labs may have worked with these agents in the past and may still have specimens but not realize it. Thus they would erroneously inform the government that they are not working with dangerous biological agents, leaving an undisclosed source of bioweapons for a researcher with devious intentions.

"That would be a concern," Curlett said, but added, "We believe these labs want to be in compliance and want to protect the bioterrorist security of the U.S." In addition, APHIS would "encourage them to look at their inventory and know what they have."

Shoemaker agreed that there is a possibility that some labs working with these agents may be overlooked.

Academic labs are one of the most likely facilities that may be missed, Miller said. "Investigators move on to other projects and don't clean out their freezers, so they forget they even have the stuff and it may never be discovered," he said.

A bioterrorism expert who spent time as an academic researcher and who requested anonymity told UPI that compliance with this new law "is likely to be low" among academicians.

"Academics are not good record keepers when it doesn't advance their work and they perceive it as unnecessary," the source said. "They will do what's necessary for safety but they let the paperwork slip," and hence will probably fail to notify the government of agents they have in their lab.

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Miller said, "The reality is that the government is not going to investigate an academic investigator at Berkeley or MIT for failing to send in a registration form." Most researchers will "view it as an empty threat," he said.

Shoemaker said, "Biosecurity is going to very much rest with the integrity of personnel who have access to it." Because biological materials are self-replicating, they are different from nuclear and chemical weapons, she said. "You can't just take inventory and lock them up" because more can always be grown, she said.

Compliance is "always a problem," Prior said. "Unfortunately in all these cases, the advantage is with the bad guy because the bad guy doesn't have to tell the truth."

"We're never going to have 100 percent certainty of protecting us from people with nefarious intentions almost no matter what you do," Miller said.

Another loophole is the availability of these biological agents in other countries. A bioterrorist expert who requested anonymity said the CIA is more concerned with the threat of these agents being obtained internationally than domestically.

"No matter how much security we have in this country, it can always be obtained internationally, and if other countries don't have similar regulations we're all still at risk," Shoemaker explained.

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However, Prior said the U.S.'s effort to uncover dangerous agents "increases the pressure on other nations to do the same." But he added that for the vast majority of countries, "we won't have any idea what they've got."

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