By John Schwartz
The controversial EPA report concluded environmental tobacco smoke is a Class A carcinogen, as hazardous as radon and responsible for some 3,000 lung cancer deaths each year. The tobacco industry promptly sued in federal court to force the study to be withdrawn, arguing that the agency ignored accepted scientific and statistical practices in making its risk assessment -- a contention made at the same time by many independent scientists.
After five years of court pleadings and deliberations, U.S. District Court Judge Thomas Osteen, of the Middle District of North Carolina, ultimately agreed with the industry. He issued his opinion late Friday, and many EPA and tobacco industry officials were still unaware of it even when contacted last evening.
EPA Administrator Carol M. Browner said in a telephone interview last night the opinion is "disturbing" because "it's so widely accepted that secondhand smoke causes very real problems for kids and adults. Protecting people from the health hazards of secondhand smoke should be a national imperative."
Browner said the administration would almost certainly appeal the decision.
Michael York, an attorney for cigarette giant Philip Morris Cos., called Osteen's decision "a very important ruling" that could force the EPA to reverse its stand on secondhand smoke. "Now it will be up to the agency to reexamine all of the relevant studies and make the honest determination that the statistical correlations are extremely weak -- certainly below that necessary to justify their classification of [secondhand smoke] as a Class A human carcinogen."
Reports on the effects of secondhand smoke have long been controversial. While all credible scientific authorities say that cigarette smoking causes cancer, secondhand smoke involves such a low concentration of carcinogens that a strong cancer connection is hard to establish.
A number of studies have found secondhand smoke to raise the risk of cancer about 20 percent -- an increase many epidemiologists say does not constitute convincing proof. Others argue that exposure to secondhand smoke is so widespread that even small increases translate into large numbers of sick people.
Reports continue to emerge with findings that both support and undercut the EPA thesis. A 1998 study by California's environmental protection agency found that secondhand smoke is a potent carcinogen.
A new study, by the International Agency for Research on Cancer, found no statistically significant risk to secondhand smoke. The tobacco industry accused the study's sponsors, the World Health Organization, of trying to suppress the findings; WHO said the companies "completely misrepresented" the study.
Osteen ruled the EPA had wrongly used provisions of the 1986 Radon Gas and Indoor Air Quality Research Act in determining that secondhand smoke is hazardous. That act required a broad-based panel to be convened for such findings, including representatives of affected industries, but the agency excluded industry voices, the judge ruled.
From the time the report was issued, even scientists not affiliated with the industry criticized the EPA for using too low a standard for what constitutes causation rather than chance.
Osteen agreed that the agency's science was lacking. "Using its normal methodology and its selected studies, EPA did not demonstrate a statistically significant association between [secondhand smoke] and lung cancer," he said. Statistical significance is the scientific standard that separates interesting results that could be the product of chance from more convincing evidence that is likely to constitute a true association.
"EPA publicly committed to a conclusion before research had begun; excluded industry by violating the Act's procedural requirements; adjusted established procedure and scientific norms to validate the Agency's public conclusion, and aggressively utilized the Act's authority to disseminate findings to establish a de facto regulatory scheme intended to restrict Plaintiffs' products and to influence public opinion," Osteen wrote.
An EPA official who asked not to be named said the agency's process included peer review and provided the "functional equivalent" of the requirements of the Radon act; the official also said that the judge did not have standing to rule on the EPA report because it was not a formal rule-making or final agency action.
Since the report was issued, indoor smoking bans have popped up in hundreds of states, cities and counties. California, for example, prohibits smoking even in bars.
The blow to the EPA report could give new energy to opponents of these bans, since "the release of the original risk assessment gave an enormous boost to efforts to restrict smoking at the state and local levels," said Matthew L. Myers, a spokesman for the National Center for Tobacco-Free Kids.
In addition, a number of lawsuits filed against tobacco companies over claims of injury from secondhand smoke still lie in the balance. For example, a class-action suit was settled with airline flight attendants last year for $349 million, but individuals still have to sue the industry and prove that secondhand smoke harmed them -- which could be more difficult without the EPA's support.
Myers said, however, that the one judge's ruling could not blunt the national trend -- especially given that so many reports have found secondhand smoke dangerous. "While the move to restrict smoking indoors could be temporarily set back by this decision," he said, "it won't be stopped."