The tobacco industry has sued the Environmental Protection Agency in an attempt to overturn the agency's recent designation of secondhand tobacco smoke as a potent carcinogen that kills some 3,000 Americans a year.
The lawsuit filed Tuesday alleges that the EPA manipulated scientific studies and ignored scientific and statistical practices in making its risk assessment. The suit, filed in U.S. District Court in North Carolina by industry giants R.J. Reynolds and Philip Morris and four groups representing growers, distributors and marketers, also alleges that EPA exceeded its regulatory authority in declaring secondhand smoke a known cause of cancer.
Tobacco company spokesmen said the EPA action has provoked hundreds of government and private efforts to ban or restrict indoor smoking that have resulted in economic harm to the industry.
"The EPA, when it could not reach its predetermined conclusion with the available data, simply changed generally accepted statistical practices to achieve its findings," charged Dan Donahue, an R.J. Reynolds vice president and counsel.
In a terse response, EPA administrator Carol Browner said: "This assessment is based on scientific evidence that has been thoroughly peer-reviewed and we stand by it."
The EPA's designation of second-hand smoke as a carcinogen was an action instituted by Browner's Republican predecessor.
The EPA's January 7 declaration on the hazards of "environmental tobacco smoke," or ETS, had no direct effect on smoking regulations since the agency has no authority to regulate indoor air quality. But as a practical matter, EPA's placement of ETS in the same category as radon and asbestos, and declaration that it causes hundreds of thousands of respiratory illnesses in children, has had a powerful impact on the movement to create smoke-free workplaces.
Donahue said that 145 local governments have instituted smoking bans since the EPA announcement.
But Donahue had no figures to back up the claim that the EPA action has economically harmed the tobacco industry.
"We don't have any specific figure that would represent bills for any one company directly related to this EPA action," he said.
"There is no loss from it as it stands now," said John Maxwell, a tobacco industry analyst with the Richmond firm of Wheat First Butcher and Singer. The decline in smoking this year, said Maxwell, is about 2 percent, consistent with the annual slide observed over the past few years.
Bill Wordham, an official with The Tobacco Institute, said the fear is that the future financial impact could be huge.
"I'm not sure you could show a clearly demonstrated financial loss or job loss. . . . but I don't think there's any doubt about the potential," he said.
Anti-smoking activists derided the suit as the desperate act of an industry fighting a rear-guard action against scientific evidence fearful of its economic future.
"Despite literally tens of thousands of studies on what we call active smoking, they deny smoking causes cancer in smokers," said John F. Banzhaf, a law professor and executive director of Action on Smoking and Health in Washington. "So there's no way they're going to admit secondhand smoke can cause cancer."
Whether or not the suit succeeds in court, it is almost certainly going to spark a lively debate on the whole subject of risk assessment, an often controversial process. The EPA study, for example, employed meta-analysis, a statistical technique of combining the results of numerous small studies to reach a broader conclusion that might not be justified by any single one.
In its lawsuit, the tobacco companies and their co-plaintiffs argue that EPA's conclusion flies in the face of the results of 24 out of 30 scientific studies, and that "EPA was able to reach its conclusion only by manipulating and "cherry-picking' data."
The suit criticizes only EPA's conclusions about cancer risk, specifically arguing the agency used sloppy or questionable methods to analyze the 30 different medical studies it reviewed.
EPA estimated that long-term exposure to household smoking increases a non-smoker's risk of cancer by 19 percent, and accounts for about 3,000 cancer deaths a year. Annual deaths from lung cancer in the United States total about 160,000.
In reaching this conclusion, the agency used a somewhat unusual yardstick of accuracy. When reporting their results, most medical researchers use what is known as a "95 percent confidence level." That means there is no more than a 5 percent chance the conclusion is wrong and the experimental results occurred purely by chance.
Fewer than half the studies examined by EPA find an association between environmental smoke and cancer with that degree of certainty. However, when the "threshold" is lowered to the 90 percent confidence level _ where there's a 10 percent chance any experimental result is wrong _ many more studies show a link between ETS and cancer.
This decision essentially lowered the hurdle that scientific evidence had to jump over in order to convince EPA of ETS's danger to the public. The EPA followed a similar practice in evaluating the relationship between radon gas exposure and lung cancer.
"This is a little bit worse than bad science," said Donahue.
The agency defended the statistical practice Tuesday, saying the unquestionable link between smoking and lung cancer (as between cancer and high-dose radon exposure in uranium miners) makes it defensible to accept a slightly lower standard of proof in the case of ETS.
"If you have a body of evidence that is pointing you toward a conclusion, and the question is do you need to be 90 percent sure or 95 percent sure that the effects you are seeing aren't just due to chance, then we think it is reasonable to accept 90 percent certainty," said William H. Farland, director of the EPA's office of health and environmental assessment.
_ Information from the Associated Press was used in this report.