Risk assessment: the Supreme Court rules define significant risk on the basis of the “best available evidence.” Thus, while regulatory agencies retain considerable flexibility, are free to use “conservative assumptions” and to risk “error on the side of overprotection,” they can no longer impose the entire burden on industry. At the very least, the regulators now have a threshold responsibility to establish the need for more stringent standards. In a case decided just prior to its summer recess, the U S . Supreme Court held that 1he benzene standards written by the Labor Department’s Occupational Safety and Health Administration (OSHA) were invalid on the grounds that OSHA had not made a “threshold” finding that benzene poses a significant health risk and that a new lower standard is therefore “reasonably necessary or appropriate” (Industrial Union Department u . American PetroEeum Institute, 48 Law Week 5022). The plurality opinion, from which four justices dissented, directly impacts, other ongoing standard setting within OSHA, EPA, and other agencies and will shape the environmental rulemaking process.
Burden of proof OSHA argued that there is ample evidence to support the conclusion that there is no absolutely safe level for a carcinogen and therefore the burden belongs to industry to prove that a safe level for exposure can be determined. The Court, rejecting this argument, stated that “the burden was on the agency t.0 show. on the basis of substantial evidence, that it is at least more likely than not that long-term exposure . . . presents a significant risk of material health impairment.” This was qualified by the finding that “significant risk” is not a “mathematical straitjacket,” but rather that the agency has the responsibility to 0013-936X/80/0914-1051$01 .OO/O
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Cost-benefit analysis One important related question, which was directly addressed only in a separate opinion by Justice Powell, is the relationship between the expected benefits of regulation and the cost to industry. Powell found that “the statute requires the agency to determine that the economic effects of its standard bear a reasonable relationship to the expected benefits.’’ A standard is neither “reasonably necessary” nor “feasible” if it requires “expenditures wholly disproportionate to the expected health and safety benefits.” The full Court is expected to confront this issue during its fall term in a case brought by the steel industry challenging OSHA’s standards for coke oven emissions (American Iron & Steel Institute u . OSHA, No. 78-919). Further highlighting this debate, the U S . Court of Appeals for the District of Columbia recently rejected arguments by the lead industry that EPA did not properly weigh economic considerations in holding that the agency had not exceeded its authority by “promulgating a primary air quality standard for lead which is more stringent than necessary to protect public health .”
EPA and OSHA cancer policies At stake are the cancer policies of both agencies. OSHA’s is in the early stages of litigation while EPA’s “airborne carcinogen policy,” originally
1980 American Chemical Society
proposed in October 1979, has been further delayed to provide additional opportunity for public comment when EPA’s Science Advisory Board Subcommittee meets in November. Reacting initially to the benzene decision, EPA’s assistant administrator for pesticides and toxic substances was qusted as saying, “The Court may have set an impossible standard. By the time the proof arrives in the form of dead bodies, it will be too late.” Since then the agency has closed ranks behind the position that it is complying with the degree of analysis required by the Court to determine a “significant risk” and that its carcinogen policy and other standard setting therefore will not be affected.
Continuing debate While the Supreme Court did reject out-of-hand OSHA’s benzene standard and did shift the agency’s traditional concept of burden of proof, it by no means resolved the critical question of risk assessment upon which so much of environmental regulation now hinges. Still very much at issue is how a significant risk can be quantified. By its plurality 5-4 decision, the Court served notice that to achieve agreement within the legal community is every bit as difficult as reaching concensus among scientists. The minority viewed the key issue in such cases to be one of “scientific uncertainty” and felt that “the existing evidence may frequently be inadequate to make the threshold finding of ‘significance’ . . .” It further hinted that in cases where human lives are at stake, a cost-benefit analysis may not be appropriate-a position long espoused by environmental groups. The debate over how to approach the regulation of carcinogens has just been joined and is certain to be one of the more pervasive and persistent environmental problems of this decade. Volume 14, Number 9, September 1980
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