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WASHINGTON - Five years before the first case of mad cow disease was discovered in the United States, the Department of Agriculture asked Harvard University's Center for Risk Analysis to evaluate whether existing safeguards could prevent the disease from spreading to humans and animals.
The center concluded it was "extremely unlikely" that mad cow disease, or bovine spongiform encephalopathy (BSE), would establish itself in the United States. Even if cases were reported, the center said, it was "virtually certain" the disease would burn itself out within 20 years because of steps federal regulators already had taken.
Now, as the Bush administration and the cattle industry deal with the fallout from the discovery of an infected Holstein at a Washington state dairy farm shortly before Christmas, the Harvard study has become their bible. Administration officials from Agriculture Secretary Ann Veneman on down cite it frequently as proof there is nothing to worry about.
But the study, and the Harvard center, has it critics.
Consumer groups say the Harvard center has a reputation for "soft" scientific studies, often funded by private corporations.
"It's notorious for invariably underplaying public health concerns," said Michael Hansen, who tracks food safety issues for Consumers Union.
Even the head of an international panel of experts hired by Veneman to review U.S. regulations questioned the Harvard study.
"Harvard says if you wait long enough, (BSE) will die out," Ulrich Kihm, chief veterinarian of Switzerland who has been in the front lines of battling the disease, told a USDA advisory committee. "But if you don't implement strong measures, it will go on and on."
The advisory committee recommended tough new safeguards including a vastly expanded testing program for BSE and even stricter restrictions on animal feed.
Founded in 1989, the Center for Risk Analysis has often provided the fodder for those who believe federal health, safety and environmental regulations provide too little benefit when compared with their cost.
Using risk analysis, cost-benefit analysis and other studies, the center over the years has looked at everything from car air bags and pesticides to cell phones and clean air regulations. It has received funding from Dow Chemical, Exxon, Pfizer, General Motors, Monsanto, 3M, ASARCO, Boise Cascade and dozens of other companies and industries that are heavily regulated.
The center's influence has spread to the inside of the Bush administration.
John Graham, who founded the center, is now President Bush's regulatory czar. Although his nomination was widely opposed by consumer and environmental groups and 39 senators voted against his confirmation, Graham's supporters said he would bring some sanity to the Byzantine world of federal regulations.
As head of the Office of Information and Regulatory Affairs at the White House, Graham has to sign off on hundreds of regulations proposed by federal agencies every year, including any final regulations from the Agriculture Department and the Food and Drug Administration involving mad cow disease.
"It's his shop that will pass judgment," said Tony Corbo, who has been tracking mad cow issues for Public Citizen.
While the Harvard center's BSE study made no recommendations, it concluded that even if animals infected with mad cow had been imported from Europe during the 1980s and 1990s, existing regulations were more than adequate to protect human health and prevent the disease from spreading.
The study looked at a number of different scenarios, including the possibility BSE could be spread to cattle by pigs, mink, deer and elk and other animals infected with similar diseases. Computer models were developed that mimicked how the cattle industry operates, how and what cattle are fed, how they are moved from farm to farm, how they are slaughtered and how their parts are rendered.
Thousands of computer simulation runs were made and the conclusion was always the same.
"If BSE has been introduced into the U.S., as had been suggested by some observers, the course of the disease has been arrested, and it is destined for eradication by the measures currently in place," the report said.
One of the authors of the report, George Gray, said Kihm and others "misunderstand" the report and its methodology and have been too quick to criticize the results.
"I think we did a pretty good job," said Gray, who has met with Kihm and another member of the international panel, William Hueston, director of the Center for Animal Health and Food Safety at the University of Minnesota.
Hueston said he didn't find a lot of disagreement between the Harvard study and what an international panel of experts recommended.
"I think the Harvard risk assessment and the international panel said pretty much the same thing," he said.
But Hueston also said more cattle need to be tested and a broader ban adopted on feed that could be contaminated. Scientists believe BSE spreads through cattle feed that could include parts of animals infected with the disease. Although such feeds have been banned since 1997, there are concerns that the ban needs to be expanded to include feed for other animals.
Corbo, Hansen and others skeptics of the Harvard center's BSE study said it was based on computer models that may have included outdated assumptions.
One example, they say, is the Harvard study's assumption that a cow would have to eat 1 gram of infected material to come down with the disease. Kihm said most scientists now believe a cow would have to eat only 10 milligrams of infected material, a piece the size of a peppercorn, to catch the disease. That's 100 times smaller than the assumption in the Harvard study.
Recent British studies suggest the infectious dose could be 400 micrograms, which is 25 times smaller than 10 milligrams, said Hansen.
"They (the Harvard center) way overestimated the infectious dose," he said.
The Harvard center's BSE study was requested by the Agriculture Department, and there are no signs it received financial support from the cattle industry. But among the dozens of individuals the authors acknowledge provided scientific input and support were some with ties to ConAgra Beef, the National Cattleman's Beef Association, the National Renderers Association and the American Feed Industry Association.
Although industry groups were consulted, consumers groups were shut out, Corbo said. Hansen's name, however, appears in the list of acknowledgments.
Hueston, Corbo and others argue that even though the Europeans, including Britain, where BSE was discovered, have implemented even more rigid safeguards on animal feed than the United States, cases of mad cow disease continue to be found.
"There is a disconnect between the Harvard study and the facts," Corbo said.
But Hueston and Gray said the number of cases in Europe and Britain have been in decline since the feed bans took effect. Symptoms of the disease can take four or five years to appear in infected cattle.
Last year, there were 425 cases of BSE reported in Britain. That's down from a high of more than 1,000 cases a week at the peak of the outbreak in the early 1990s.
"The animals we are seeing now are tail-end animals, the last ones infected before the feed bans," Hueston said. "The difficulty of this disease is it can take four and a half or five years before you know whether new regulations are working."
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