"Risk Analysis in the Courts: A Roadmap for Risk Analysts"
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Poster 13a
JUDICIAL REVIEW OF REGULATORY ACTION
Anatomy of Judicial Review
DECISION POINTS
Legislative identification of problem, strategies, and goals
Agency decision to take action
Agency investigation
Notice of proposal
Comment, paper hearing, real hearing, etc.
Submission to OMB, other agencies, boards, etc.
Final agency decision (general rule or individual order)
Judicial review in district court or court of appeals
Dismissal of petition
Judicial review is only rarely available before the promulgation of a final agency action.
Flue-Cured Tobacco Cooperative Stabilization Corporation v. EPA, 857 F.Supp. 1137 (M.D.N.C. 1994).
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 involve complicated and highly technical scientific evidence? In Flue-Cured Tobacco Cooperative Stabilization Corporation v. EPA, 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 method‑ology 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 lassification. 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. [Roth-Nelson]
Poster 13b
KEY DIFFERENCES FROM CIVIL LITIGATION
Legal standard for taking action: low-level risk is sufficient, as opposed to likelihood of harm
ACTUAL HARM IMMINENT HARM SIGNIFICANT/ACCEPTABLE DE MINIMIS
NEGLIGIBLE ZERO
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Ethyl Corp. v. EPA, 541 F.2d 1 (D.C. Cir. 1976) (en banc).
The D.C. Circuit established that Congress could and had decided to regulate on the basis of risk rather than actual harm. "[E]ndanger [in the Clean Air Act] means something less than actual harm..., A statute allowing for regulation in the face of danger is, necessarily, a precautionary statute. Regulatory action may be taken before the threatened harm occurs . . . ." The court went on: "Where a statute is precautionary in nature, the evidence difficult to come by, uncertain, or conflicting because it is on the frontiers of scientific knowledge, the regulations designed to protect the public health, and the decision that of an expert administrator, we will not demand rigorous step‑by‑step proof of cause and effect. . . . [Instead,] in such cases the Administrator may assess risks. "Moreover, the court allowed regulation on a "reasonable" or "potential" showing of danger, hardly the "probable" finding urged by Ethyl as the proper reading of the . . . Clean Air Act . "The reason this relatively slight showing of probability of risk justified regulation is clear: the harm to be avoided, cancer, was particularly great."
The Toxic Substances Control Act, 15 U.S.C. '2605.
TSCA Permits regulation on the basis of risk rather than actual harm, but it does not require the achievement of a risk‑free state, but rather the elimination of "unreason able" risks. Between actual harm and zero risk lie several different risk levels that different statutes and courts give different names. For one attempt to rank the various risk levels, see John S. Applegate, Worst Things First: Risk, Information, and Regulatory Structure in Toxic Substances Control, 9 Yale J. on Reg. 277, 308‑09 (1992).
Synonyms for "acceptable": significant, unreasonable, protective
Several different names are given to the point between actual harm and zero risk at which regulatory action is authorized or required. With the exception of the Clean Air Act Amendments of 1990, which mandate a 1/1,000,000 residual risk level for hazardous air pollutants, 42 U.S.C. '7412(f), Congress invariably uses a verbal or narrative standard to describe this point.
Burden of proof in licensing
In licensing statutes, the burden of proof is on the applicant seeking a license, unlike ordinary regulations in which the agency carries the burden of proof. In environmental law, the most prominent example of a licensing statute is the federal pesticide law, FIFRA. "The burden of establishing the safety of a product requisite for compliance with the labeling requirements [for pesticides] at all times [rests] on the applicant and registrant." Environmental Defense Fund v. EPA, 465 F.2d 528, 532 (D.C. Cir.1972).
Deference to agency
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A decision is in place (court is not forum of first instance)
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Coordinate, policymaking branch of government
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Agency expertise
Statute must trigger liability for action
Long Island Pine Barrens Society v. Planning Board of the Town of Brookhaven, 80 N.Y.2d 500, 606 N.E.2d 1373 (1992).
This is a case of judicial bucking of responsibility for a large environmental risk to the legislature occurred in the New York Court of Appeals, the state's high court, found that the Pine Barrens region was "an indispensable component of the aquifer system that is the sole natural source of drinking water for over two and a half million inhabitants of Long Island," and that this component was threatened by 224 separate proposed development projects. The plaintiffs sought a cumulative environmental impact statement that would review the danger posed by these developments to the drinking water supply. While the Court agreed that "an exhaustive and thorough approach to evaluating projects affecting this region is unquestionably desirable and, indeed, may well be essential to its preservation," it refused to step in. The state legislature had created a planning body which had failed to do its job. The Court ruled that "[w]e in the judiciary are not free to piece together statutes and regulations that were never meant to address a problem of this magnitude in order to fill the gap left by the responsible planning entity's inaction," and "the solution must be devised by the legislature." To the amazement of all, the legislature, faced with this judicial call to action, did devise a solution C the creation of a new mechanism for cumulative impact review. [Gerrard]
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Copyright © 2000.
John Applegate and Wendy Wagner.
Last modified September 28, 2000