Federal Court Rejects EPA Secondhand Smoke Study

Published September 1, 1998

In one of the most embarrassing setbacks for EPA in recent memory, a federal judge has thrown out the agency’s landmark 1993 risk assessment linking secondhand smoke to cancer.

The ruling, handed down July 17, invalidated EPA research linking exposure to secondhand smoke, also known as environmental tobacco smoke (ETS), to 3,000 cancer deaths each year. The agency’s ETS risk assessment was subsequently challenged by tobacco industry officials who feared–quite rightly, as it turned out–that the agency’s findings would be used to justify smoking bans in public places. Tobacco companies argued that EPA cherry-picked data and ignored standard scientific and statistical practices to reach its conclusions, an opinion shared by a large number of independent scientists.

The new court ruling could have a profound effect on the risk assessments and other scientific reviews periodically released by the federal government. If allowed to stand, the decision will establish a precedent that risk assessments are subject to judicial review in instances where they have a regulatory impact. That prospect is nothing short of a nightmare for federal agencies unaccustomed to seeing their scientific pronouncements challenged in court.

In his blistering 92-page decision, Judge William Osteen of the Middle District of North Carolina essentially vindicated those who had accused EPA of manipulating data in order to reach a preconceived conclusion. Osteen ruled that EPA had violated provisions of the 1986 Radon Gas and Indoor Air Quality Act, under which the agency determined that exposure to ETS is hazardous.

“EPA publicly committed to a conclusion before research had begun; excluded industry by violating the Act’s procedural requirements; adjusted established procedure and established 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 Plaintiff’s products and to influence public opinion,” Osteen wrote.

Among other things, the Act requires that a broad-based, stakeholder advisory panel–one that includes the participation of affected industries–be convened to review the findings of EPA research alleging a substance is dangerous to human health. Judge Osteen noted, however, that the tobacco industry had been excluded from the secondhand smoke panel.

“Findings Based on Selective Information”

Osteen added that EPA’s findings were based on insufficiently rigorous statistical tests and were therefore invalid. EPA, he noted, “disregarded information and made findings based on selective information . . . ; deviated from its risk assessment guidelines; failed to disclose important [opposition] findings and reasoning; and left significant questions without answers.”

Osteen’s ruling isn’t expected to have much impact on smoking bans already in place. (Some California communities might be an exception, where bans on smoking in bars are immensely unpopular with patrons and owners.) But the ruling is certain to discourage lawsuits aimed at recovering damages for people claiming to have been harmed by exposure to ETS. Plaintiffs will no longer be able to cite EPA’s now-discredited risk assessment to buttress their claims.

No Choice but to Appeal

Although legal observers agree Osteen’s ruling is likely to be upheld by a higher court, EPA has little choice but to appeal. Risk assessments are the foundation of the agency’s regulatory action. To have one of its high-profile risk assessments invalidated by a federal judge for violating standard scientific and statistical practices is nothing short of an humiliation for EPA. It raises serious questions about the science underlying other EPA regulatory decisions, including last year’s controversial decision to tighten standards for particulate matter and ground-level ozone. That action is also being challenged in court, with a ruling expected in the next twelve months.