| 1998 Full-text Online
Casebook: "Risk Analysis in the Courts: A Roadmap for Risk Analysts" |
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Poster 16a JUDICIAL REVIEW OF REGULATORY ACTION Site-specific Decisions SETTINGS CERCLA, landfill siting, facility siting, permits (air, water, multimedia) FUNCTIONS OF RISK ANALYSIS Baseline risk assessment Identify areas for risk reduction Determine degree of clean‑up activity SPECIAL CHALLENGES FOR RISK ANALYSIS Multiple exposure pathways Multiple toxins Unlikely or extreme scenarios Sierra Club v. Utah Solid and Hazardous Waste Control Board, 964 P.2d335 (Utah App. 1998). Environmental, anti‑chemical weapons, and veterans groups sued to prevent the testing of anchemical‑weapons incineration facility in Tooele County, Utah. For screening purposes, the Army's risk assessment had used assumptions that "intentionally overstat[e] what is known to be true." The court held that the plaintiffs erred in taking the results obtained thereby at face value. The Board was entitled to permit the test burn on the ground (among others) that risks based on human exposure via milk were irrelevant since no dairy farming in fact occurred in the area. This case suggests that agencies and courts are able to understand and account for intended conservatism in risk assessments, as long as the assumptions in question are fully disclosed. [Applegate] Contra Costa County v. Peña, 1998 WL 164966 (N.D. Cal. 1998). In this case a county government challenged the Department of Energy's decision to repatriate foreign spent nuclear fuel to the United States through a military port within the county's borders. The county's primary challenge was to the risk assessment in the environmental impact statement, regarding the health effects of a terrorist attack on the fuel. Throughout the EIS, DOE deliberately chose to study the "upper bound" risks of such events, but concluded that a quantitative estimate of the risk of such an occurrence was inappropriate. The court upheld DOE's judgment, explaining that it was reasonable for DOE to conclude that the likelihood of such an event occurring was extremely remote, in view of the nature of the containers and the extensive security measures being employed. [Applegate] Communication and justification Sierra Club v. U.S. Army Corps of Engineers, 772 F.2d 1043 (2d Cir. 1985). A poor effort at risk communication proved fatal to an enormous public works project. The risk involved was the effect that a landfill in the Hudson River along the west bank of Manhattan, built to support an interstate highway to be called Westway, would have on the striped bass. The draft supplemental environmental impact statement prepared by the Corps of Engineers concluded that the proposed landfill would cause a "significant adverse impact to the Hudson River Stock of this species." After public hearings but no new data collection, the final supplemental EIS concluded that the perceptible long‑term decline in stock would be difficult to discern from normal yearly fluctuations and would have only "minor impacts" on the fishery. The FSEIS offered no explanation for the change. When sued by project opponents, the Corps of Engineers argued that in using the word "significant" in the draft it was employing a term of art that is defined as "measurable but minor." The Second Circuit concluded that "[n]either [the District Court] nor we are required to defer to the Corps' Orwellian‑like >doublespeak,'" and that "the change from >significant adverse impact' to >minor impacts' required an explanation and that explanation should have been in the final report." The Second Circuit affirmed the revocation of the permit issued by the Corps for the project. With that, after 15 years of planning and $100 million in expenditures, the $1.5 billion Westway project was abandoned. [Gerrard] RANGE OF JUDICIAL RESPONSES Confrontation United States v. Broderick Investment Co., 955 F. Supp. 1268 (D. Colo. 1997). Judge Weinshienck reviewed the request of the United States for reimbursement of its costs incurred in connection with cleaning up the Broderick Wood Products Company site in Colorado. Under section 107(a) of the Comprehensive Environmental Response, Compensation, and Liability Act ("CERCLA"), the United States is entitled to recover all costs incurred in responding to the release or threatened release of a hazardous substance that are not inconsistent with the National Contingency Plan. At issue was the U.S. Environmental Protection Agency's choice of cleanup remedy for groundwater contamination. In determining the appropriate remedy for a site, the National Contingency Plan provides that, for known or suspected carcinogens, acceptable exposure levels are generally concentration levels that represent an upper bound lifetime cancer risk to an individual of between 1 X 10 ‑4 and 1 X 10‑6 . For this site, EPA chose a cleanup level of 10‑5 , or the odds that one case of cancer would result for every 100,000 persons subjected to continual exposure to the site over a 70‑year lifetime. The defendants argued that EPA should have selected the less protective standard of 1 X 10 ‑4 . Among the reasons found by the judge for holding that EPA's decision to require that the site be cleaned up to a 1 X 10‑5 risk factor was arbitrary and capricious was the judge's determination that a 10‑5 risk factor is only appropriate for a population of 100,000 or greater: If fewer than 100,000 are exposed, the one additional incident of cancer prevented by using a 105 's risk factor will never be realized, and a 104 factor is appropriate. Because of the improbability that 100,000 persons might live or work in close proximity to the Site, the Court is satisfied that it was arbitrary and capricious for EPA to utilize a risk factor of 105 . Under the Broderick case, therefore, it is arbitrary and capricious for the government to chose or impose a cleanup risk level unless exposure to that level of risk would be expected to result in or "realize" at least on cancer among persons living or working in close proximity to the source of contamination. However, regardless of whether the exposed future population at the Broderick site turns out to be 10 or 10 million, the probability of one exposed person developing cancer would still be the same. Under the court's logic, EPA would have to accept an individual cancer risk of 1 in 100 in a community of 100, yet could protect to a risk level of 1 in 100,000 in a community of 100,000. The result C persons living in more sparsely populated communities would receive less environmental protection, and be exposed to greater risks, than those living in more populated areas. [Kuehn] Poster 16b RANGE OF JUDICIAL RESPONSES (CONT.) Avoidance Salmon River Concerned Citizens v. Robertson, 32 F.3d 1346 (9th Cir. 1994) Can a government agency justify herbicide spraying based on a health risk analysis that provides a safety factor of 100 when extrapolating low‑level human risks from laboratory animal studies? In Salmon River Concerned Citizens v. Robertson, a public interest group challenged a Forest Service Environmental Impact Statement (EIS) that evaluated the health risks of herbicide spraying. The Ninth Circuit Court of Appeals found the risk assessment was adequate and contained standard risk assessment methodology. The court approved the safety margins the agency built into the risk analysis to account for uncertainty in predicting the toxic effects of herbicides: (a) a safety factor of one order of magnitude (10 times) applied to the No‑Observable‑Adverse‑Effects Level (NOAEL) measured in laboratory animals exposed at high levels to adjust for extrapolating human response at low levels of exposure; and (b) another safety factor of an order of magnitude applied to the NOAEL to allow for specially sensitive individuals. The court did not accept plaintiffs' argument that the risk analysis failed to adequately discuss risks of herbicide exposure for persons with multiple chemical sensitivity syndrome (MCSS). The agency's safety margin of 100 (or two orders of magnitude) was considered sufficient to protect those individuals in view of a consensus in the scientific community that there is no definable, discrete MCS syndrome and it cannot be determined what causes a reaction in a chemically sensitive person. Further, the Forest Service intentionally overstated the risks of harm posed by active ingredients to account for the uncertainty regarding the toxicity of ingredients, particularly inert substances, not previously studied by the EPA. The plaintiffs argued that two orders of magnitude were insufficient, and the EIS concedes that "unusually sensitive individuals may experience effects even when the margin of safety is equal to or greater than 100." The position taken by the District Court, 798 F.Supp. 1434, 1442 (E.Dist.Cal. 1992) was: An EIS need not quantify every risk, particularly less likely risks. Moreover, the risk analysis used by the government, [using] a margin of safety of 100, is the scientifically accepted method. The Court of Appeals' standard of review was Oregon Envtl. Counsel v. Kunzman, 817 F.2d, 484, 491 (9th Cir. 1987):[T]he court cannot substitute its judgment for that of the agency in question, as the agency has a measure of expertise in the area which the court lacks. Thus, the District Court decision to deny a motion for summary judgment favoring the plaintiffs was affirmed. This decision may affect how a regulatory risk assessment is performed to account for protecting sensitive individuals or subpopulations in a normal population, or how threshold limits of exposure are interpreted where plaintiffs in a civil lawsuit allege special sensitivity. [Roth‑Nelson] Deference In Weyerhauser Co. v. Costle, 590 F.2d 1011 (D.C. Cir. 1978), the U.S. Court of Appeals for the District of Columbia Circuit considered plaintiffs' claim that the federal Environmental Protection Agency's (EPA's) regulations establishing effluent discharge standards for the paper mill industry were invalid because, inter alia, EPA failed to consider the quality of receiving bodies of water. Plaintiffs argued that: 1) certain paper mills discharged wastewater into the Pacific Ocean; 2) the Ocean naturally dilutes or treats the effluent; and 3) EPA should use "common sense" by considering the capacity of the Ocean ("receiving water capacity") in setting effluent limitations. EPA argued, and the Court of Appeals held, that Congress limited the role of water quality in setting industrial effluent limits only to making limits more stringent than they would be using technology‑based approaches. Among other factors, the Court found that a water quality‑based approach would not work for various reasons; that Congress "considered uniformity vital" to avoid forum shopping by companies and wooing by states; and that the Clean Water Act's technology‑based approach "implemented changing views as to the relative rights of the public and of industrial polluters." The Court noted that under traditional common law principles, "the right of the polluter was preeminent, unless the damage caused by pollution could be proven." It concluded that "henceforth," under the Clean Water Act, "the right of the public to a clean environment would be preeminent, unless pollution treatment was impractical or unachievable. "The Court found that uncertainty about the effects of pollution was a major cause of this new approach: "This new view of relative rights was based in part on the hard‑nosed assessment of our scientific ignorance: >we know so little about the ultimate consequences of injection of new matter into water that [the Act requires] a presumption of pollution.'" [D. Markell] Do you have any additions or
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Copyright © 2000.
John Applegate and Wendy Wagner. |
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