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SRA Risk Science & Law Specialty Group

Flue-Cured Tobacco Cooperative Stabilization Corporation v. EPA: Judging Complex Scientific Evidence

Was a government agency correct in asserting that its risk assessment supporting the classification of Environmental Tobacco Smoke (ETS) as a known human carcinogen was not judicially reviewable because, in part, the factual issues involved complicated and highly technical scientific evidence?

In Flue-Cured Tobacco Cooperative Stabilization Corporation v. EPA, 857 F.Supp. 1137 (M.D.N.C. 1994), district court Judge Osteen found that fact by itself does not preclude judicial review. On this question, the court cited the precedent of Ethyl Corp. v. Environmental Protection Agency, 541 F.2d 1, 35-37 (D.C.Cir. 1976).

The competence of the courts to adjudicate complex scientific disputes was an issue addressed in the affirmative by the U.S. Supreme Court in Daubert v. Merrell-Dow Pharmaceuticals, Inc., 113 S.Ct. 2786, 2800 (1993), except for the notable dissenting opinion of Chief Justice Rehnquist:

The Court speaks of its confidence that federal judges can make a "preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.

I do not doubt that Rule 702 confides to the judge some gatekeeping responsibility in deciding questions of the admissibility of proffered expert testimony. But I do not think it imposes on them either the obligation or the authority to become amateur scientists in order to perform that role.

This post-Daubert decision from North Carolina suggests that government risk assessments will continue to be judicially reviewable on issues of science itself as well as science policy.

EPA's risk assessment that classified ETS as a known human carcinogen also concluded that indoor ETS increases the risk of lung cancer in healthy nonsmokers and that exposure in children is causally linked to increased risk of lung infections, a reduction in lung function, and increased risk of asthma. Yet the EPA claimed its ETS health risk report and cancer classification did not constitute "final agency action," as required for judicial review under the Administrative Procedures Act (APA). Accordingly, no entity or individual need "pay the slightest heed" to the report or classification.

But the Middle District of North Carolina disagreed, finding that the agency's classification had direct economic effects and regulatory impact. The court did not believe Congress would have called for dissemination of research results under the Radon Gas and Indoor Air Quality Research Act (1986) as an empty gesture.

Although the EPA has no authority to regulate indoor air quality, the mandated report on research results clearly was intended to identify sources of indoor air pollution and assist other regulatory agencies in setting priorities for action. Consequently, the court found the EPA's health risk report and classification of carcinogenicity had the effect of a final agency action and was ripe for judicial review.

Even an agency risk assessment that does not accompany final rule-making may nevertheless be subject to judicial review.

[Contributed by Wayne Roth-Nelson]

CLASSIFICATION: JUDICIAL REVIEW; REGULATORY AGENCY CHEMICAL RISK ASSESSMENT; COURT JURISDICTION

Copyright © 1999 by Tec-Com, Inc.
Last modified July 29, 1999.