Abstract
The evaluation of health risks is characterized by policy judgments which in the United States often lead to judicial review. Those judgments are buttressed by scientific determination of whether a substance will produce adverse health effects or whether a low probability event will have a large consequence, given that it occurs. Science is not able to provide answers with the certainty that the courts have been accustomed to deal with in other areas. “Transcientific” questions abound; answers are often provided by fiat. Thus, whoever bears the burden of proof faces considerable difficulty in showing that an adverse effect is not likely to occur. We analyze two recent decisions by the U.S. Supreme Court, and other decisions, to establish what burden of proof and what balancing of costs and benefits are required under the law. We conclude that decision makers and the courts are troubled by the uncertainty surrounding risk assessments. Nevertheless, risk assessment provides information of fundamental importance for those making decisions involving public and occupational health.
Note: This paper is based, in part on a paper, “Risk and Benefit in Environmental Law” published in Science, V. 214: 1096-1100 (1981).
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References
There is a massive literature on theories of justice. The most significant general work in recent decades is John Rawls, A Theory of Justice (1971). There are also works applying justice principles to the distribution of health care, and theories of bioethics, which are usually formal philosphical theories applied to issues in the life sciencies. What is of special concern for risk policy is the application of a particular piece of a somewhat Utopian world view to a decision. For example, how can we value our special concern for the adverse impacts on the poorest group, and incorporate such values into the analysis?
Weinberg, Science and Trans-Science, 10 Minerva 209 (1972).
Industrial Union Department, AFL-CIO v. Hodgson, 499 F. 2d 267, 474-75 (D.C. Cir. 1974).
Ethyl Corp. v. EPA, 541 F 2nd 1, 24 (D.C. Cir. 1976).
Ibid., pp. 66-67, quoting in part from Judge Bazelon’s earlier concurrence in International Harvester v. Ruckelshaus, 478 F. 2d 615, 652 (D.C. Cir. 1973).
Ibid., at p. 69.
Gellhorn and Robinson, Perspectives in Administrative Law, 75 Colum. L. Rev. 771, 780–81 (1975).
Monsanto v. Kennedy, 613 F. 2d 947, 955 (D.C. Cir. 1979) (acrylonitrile).
EDF v. EPA, 636 F 2nd 1267, 1283 (D.C. Cir. 1980) (PCB’s).
Industrial Union Dep’t, AFL-CIO v. American Petroleum Institute, (1980).
Society of the Plastics Industry v. OSHA, 509 F 2d 1301 (2d Cir. 1975) (vinyl chloride); American Iron and Steel Institute v. OSHA, 577 F. 2d 825 (3rd Cir. 1978) (coke ovens).
The delegation doctrine is a basic principle of constitutional law which blocks Congress from delegating too much of its authority to other branches of government. Key New Deal legislation was invalidated by the courts because it gave the executive too much authority. Schechter Poultry Corp. v. U.S., 295 U.S. 495 (1935) (NIRA unconstitutional). It is a general rule that courts interpret a statute narrowly if this will avoid a finding of unconstitutionality. Justice Stevens’ plurality opinion in the benzene case does this; he raised the possibility that an open-ended grant of authority to OSHA might violate the nondelegation principle. By limiting OSHA’s authority, he avoided the issue.
Carolina Environmental Study Group v. U.S., 510 F. 2d (D.C. Cir. 1975) (Class 9 reactor accidents “almost totally unworthy of consideration” in EIS); Citizens for Safe Power v. NRC, 524 F. 2d 1291, 1300 (D. c. Cir. 1975) (low-level) radiation from Main Yankee plant acceptable).
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Alaska v. Andrus, 580 F. 2d 465, 473 (D.C. Cir. 1978) (cost of proceeding without more data may be outweighed by benefits: NEPA fails to specify level of certainty needed for environmental estimates).
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N.R.D.C. v. Train, 545 F. 2d 320 (2d Cir. 1976). The fact that current knowledge makes this difficult is “irrelevant.” See note 5 in the court’s opinion.
The Supreme Court examined the record in detail. There is little doubt that benzene causes leukemia and nonmalignant blood disorders at high exposures. Studies of U.S. rubber workers exposed to pure benzene as a solvent in the 1940s and 1950s showed a nine-fold increase in leukemia. NIOSH study of workers at two plants in Ohio in the 1940s showed a significantly higher incidence of leukemia. However, exposures were usually in excess of 100 ppm and OSHA concluded no dose-response relationship could be drawn. Only one study of low-level deaths in the workforce (0.2 expected). All three had benzene exposure of 2–9 ppm. Because all three workers were probably exposed to other occupational carcinogens, and since no leukemia deaths appeared in other worker groups with higher exposures, OSHA did not claim this study demonstrated cause and effect. The Supreme Court concluded that evidence in the record of “adverse effects of benzene exposure at 10 ppm is sketchy at best,” and said OSHA had failed to meet its responsibility to show significant risk.
Columbia Basin Land Protection Ass’n v. Schlesinger, 643 F. 2d 585, 594 (9th Cir. 1981). OCS Lands Act, 43 U.S. C. §1347(b).
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The wholly out of proportion phrase originated with Sen. Muskie. See A Legislative History of the Water Pollution Control Act Amendments of 1972, 93rd Cong. 1st Sess., at pl. 170. EPA v. National Crushed Stone Assoc. The case only dealth with variances from Phase I standards; however, the Court indicated (see note 10 of Justice White’s opinion) that it supported the view that cost-benefit is unnecessary for Phase II.
In construing the NAAQS provision, the Supreme Court held that “claims of economic or technological infeasibility may not be considered by the Administrator in evaluating a state requirement that primary ambient air quality standards be met in the mandatory three years.” Union Electric Co. v. EPA, 427 U.S. 246, 266 (1976).
Industrial Union Pep’t., AFL-CIO v. Hodgson, 499 F. 2d 465 (D.C. Cir. 1974).
American Iron and Steel Institute v. OSHA, 577 F. 2d 825 (3rd Cir. 1978).
American Petroleum Institute v. OSHA, 581 F. 2d 493 (5th Cir. 1978) aff’d on other grounds, sub nom. Industrial Union Pep’t., AFL-CIO v. American Petroleum Institute, (1980).
Means-end analysis is common in judging the constitutionality or validity of regulations. The Supreme Court has held (in a case under the Truth-in-Lending Act) that a statute allowing such rules “as may be necessary” only requires that the means chosen by the agency reasonably relate to the purpose of the statute. Mourning v. Family Publication Service, 411 U.S. 356, 359 (1972). Whether in CPSA or OSHA, “reasonably necessary” probably was not intended to limit agency authority.
AFL-CIO v. Marshall, 617 F 2d 636, 665 (D.C. Cir. 1979).
American Textile Manufacturers Association v. Donovan, 49 (1981).
International Harvester v. OSHRC, 628 F 2d 982, 988 (7th Cir. 1980), citing Turner v. Sect’y of Labor, 561 F 2d 82 (7th Cir. 1977). RMI Co. v. Sect’y of Labor, 594 F 2d 566 (6th Cir. 1979) requires ad hoc balancing to determine whether the means selected to meet the standard is “feasible.”
See, e. g., Etzioni, “How Much Is A Life Worth,” Social Policy, March–April 1979, p. 4.
For examples of the costs per life saved of these and other funding decisions, see Rodgers, Benefits, Costs, and Risks: Oversight of Health and Environmental Decision Making, 4 Harv. Env. L. Rev. 191 (1980), at pp. 194-95. This method allows us to look at societal judgments on the value of one life, in the abstract. It has traditionally been unacceptable to limit the amount we will spend to save the life of one known and endangered individual; e. g., a doctor or hospital will not evaluate the cost of saving a heart attack victim.
President Reagan signed Executive Order 12291 in early 1981which is intended to inter alia, “... reduce the burdens of existing and future regulations, increase agency accountability for regulatory actions...,” with certain specific exclusions, through Regulatory Impact Analysis. Such impact analysis should contain information on potential net benefits to include “evaluation of effects that cannot be quantified in monetary terms” and the identification of distributional effects.
McGarity, supra note 15
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Yellin, High Technology and the Courts: Nuclear Power and the Need for Institutional Reform, 94 Harv. L. Rev. 489 (1981).
U.S.C. §551 et seq.
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M. F. Sheena, “Importance of the Burden of Proof in Environmental Litigation,” The Environmental Professional, 4:75–83 (1982).
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D. D. Doniger, The Law and Policy of Toxic Substances Control: A Case Study of Vinyl Chloride, The Johns Hopkins University Press (for RFF), Baltimore (1978)
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S. Jasanoff and D. Nelkin, “Science, Technology, and the Limits of Judicial Competence,” Science, 214:1211–1215 (1981).
See Rodgers for a classification of legislative models which use cost-benefit analysis, W. H. Rodgers, “Benefit, Costs, and Risks: Oversight of Health and Environmental Decision making,” Harv. Env. L. Rev., 191 (1980).
See People Against Nuclear Energy (PANE) v. United States Nuclear Regulatory Commission, 678 F 2nd 222 D.C. Cir. (1981) Cert. granted November 1, 1982. PANE contends that the restart of TMI-1 might cause near-by residents: a) “severe psychological distress” causing or aggravating physical disorders; b) severe harm to “stability, cohesiveness and well-being... (perpetuating) loss of confidence in community institutions”; and c) “would discourage economic growth.” The NRC contends principally that the psychological effects are not sufficiently quantifiable to “permit a meaningful assessment of the phenomenon.” The DC court, Wilkey dissenting, held inter alia, that the NRC should study the effect of “post-traumatic” (i. e., effects which have occurred after the TMI-2 accident) psychological stress on near-by communities and then decide whether a supplemental EIS would be required, should it make “a threshold finding of significant new information on psychological health effects. The majority decision held that the effects of psychological stress on human health are medically “cognizable,” thus to be included under NEPA-related federal actions. Judge J. Skelley Wright attempt to single out “post-traumatic” stress leading to physical effects: NEPA does not encompass more dissatisfactions arising from social opinions, economic concerns, or political disagreements over agency policies. It does encompass “post-traumatic” anxieties, accompanied by physical effects and caused by fears of recurring catastrophe. Whether indeed it is appropriate to speak of “recurring catas-rophe” for the TMI-2 accident, in light of facts, is certainly questionable. (See Wilkey dissent, notes 36 and 37, at 242.)
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Ricci, P., Molton, L. (1984). Risk Analysis in the United States Law: Cost Versus Risk. In: Waller, R.A., Covello, V.T. (eds) Low-Probability High-Consequence Risk Analysis. Advances in Risk Analysis, vol 2. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-1818-8_23
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