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Six tobacco organizations sued the Environmental Protection Agency yesterday, challenging the scientific evidence the agency used in concluding that second-hand smoke causes 3,000 cases of lung cancer in nonsmokers each year.
The civil lawsuit filed in U.S. District Court contends that the EPA misused scientific data in a report in January that formally classified second-hand smoke as a cause of cancer. The suit listed a number of smoking bans and regulations that expressly cited the EPA’s declaration of passive smoke as a "class A" carcinogen.
These include a nationwide ban on smoking in all 400,000 Postal Service facilities that began June 13 and workplace smoking restrictions or bans at numerous private employers, including Raytheon Co., Southern California Edison Co., and Greyhound Lines Inc.
Congress is considering regulations that would greatly restrict smoking in federal buildings, again as a stated response to the EPA findings.
"What the EPA did was more political science than anything else," said Steven Parrish, a lawyer for Philip Morris USA, Philip Morris Cos.’ domestic tobacco unit.
If governments or companies want to ban smoking on the basis of aesthetic preferences, "That is one thing," he said. "But if somebody says we should ban smoking because it’s harmful to nonsmokers, they need to be able to back that up."
The lawsuit was filed by RJR Nabisco Holdings Corp.’s R.J. Reynolds Tobacco Co. unit in Winston-Salem, N.C.; Philip Morris USA, New York; Universal Leaf Tobacco Co., Richmond, Va.; Gallins Vending Co., Winston-Salem; the Council for Burley Tobacco, Lexington, Ky.; and the Flue-Cured Tobacco Cooperative Stabilization Corp., Raleigh, N.C.
EPA spokeswoman Lauren Mical defended the agency’s findings.
"EPA’s environmental tobacco smoke report has gone through extensive scientific review by scientists inside and outside the EPA," she said.
"We have faith in our scientific process. The risks associated with environmental tobacco smoke are at least an order of magnitude greater than they are for virtually any chemical or risk that EPA regulates."
Michael Greve, executive director ofthe Center for Individual Rights in Washington, said the best the tobacco companies can do is to get the courts to force the EPA to re-evaluate its findings.
"The question is how far they can get, and I think the answer lies with Congress, and I don’t know how much punch the tobacco industry has in Congress," said Greve.
Alfred Wehner, a toxicologist who headed a panel of scientists and doctors who analyzed the draft of the EPA report for the tobacco industry, said the main problem with the report "was the statistical handling of the data."
The EPA report was essentially a survey of 11 American studies of spouses of smokers. The report discussed the results of 19 other studies conducted outside the U.S. but did not include these studies in its statistical analysis.
In the combined analysis of the U.S. studies, the EPA found a "statistically significant" difference in the 119 lung cancers suffered by nonsmoking spouses of smokers and the 100 cancers in nonsmoking spouses of nonsmokers.
The finding of statistical significance may sound arcane but is quite important. It is used to establish that the excess cancers didn’t happen by chance.
Traditionally, epidemiologists have allowed a 5% possibility that the results occurred by chance. But for the second-hand smoke study, the EPA doubled that allowance for error to 10%, then used an additional statistical technique to lower the confidence level even further.
At the traditional 5% confidence level, the EPA could not have declared the association between lung cancer and second-hand smoke to be statistically significant.
Critics such as Glenn Lammi, chief counsel of the legal studies division at the Washington Legal Foundation, said that amounts to "moving the goal posts during the game."
"They changed the rules with no public comment and no explanation as to why they did it," he said.
That’s a sentiment shared by University of California at Los Angeles epidemiologist James Enstrom.
"They’re just using it so they can get an effect," said Enstrom when the EPA announced its findings.
Lammi said the stakes in the suit are much greater than the profits of tobacco companies or the rights of smokers.
"It’s a very definite slippery slope, and we think this is very dangerous for the whole community," he said, noting that a huge number of chemicals have been accused of being cancer-causing on evidence similar to that used in the second-hand smoke analysis.
"It really gives the EPA a lot of power to skew the science," said Lammi.