Osha Regulation of Low-exposure Carcinogens: a New Approach to Judicial Analysis of Scientific Evidence

• Publication year: 1990

UNIVERSITY OF PUGET SOUND LAW REVIEWVolume 14, No. 2WINTER 1991

OSHA Regulation of Low-Exposure Carcinogens: A New Approach to Judicial Analysis of Scientific Evidence

Victor B. Flatt(fn*)

I. Scientific Uncertainty in Risk Assessment: Introduction(fn1)

Both industry and worker safety advocates often complain that our country's system of risk management for low-exposure carcinogens(fn2) is not at a regulatory level sufficient to provide optimal "benefits"(fn3) to society in the worker safety area.(fn4) While industry may not consider regulations to be unfair on their face, as they are designed to correct for market failures by internalizing certain costs such as lost productivity and medical expenses,(fn5) industry often considers the regulations to be unfairly applied and overly expensive. Industry claims that these regulations impose great cost on it both directly and indirectly, while the benefits are not certain or easily quantifiable.(fn6)

Many consumer and worker advocate organizations also feel that the benefits of low-exposure carcinogen regulation are not easily quantifiable. They would argue, however, that society is not at an optimal level of regulation because benefits are undervalued.(fn7) Nowhere is this disagreement and uncertainty more apparent than in the case of suspected low-exposure carcinogens in the workplace. Such disagreements can be expected to increase as more and more substances are recognized as carcinogens at low-exposure levels. The decision to regulate such substances is clearly a congressional policy choice. However, the ultimate implementation of regulations depends upon our court system's analysis of agency regulation, including analysis of the scientific data or evidence which the agency relies upon in making its regulatory decisions. Congress provided the Occupational Safety and Health Administration (OSHA) with the power to assure a "safe and healthful" working environment for the nation's employees and the Secretary of Labor with the authority to promulgate occupational safety and health standards which are "reasonably necessary or appropriate" to accomplish this goal.(fn8)

This Article submits that the current judicial analyses of scientific studies or data upon which OSHA relies in its regulation of low-exposure carcinogens are often uninformed and inadequate, and that these analyses may prevent OSHA from achieving the level of substance regulation mandated by Congress. This Article advocates an alternative approach to judicial review of the scientific evidence upon which OSHA relies in its regulatory duties. A uniform judicial approach toward the analysis of statistical evidence and the use of a scientific master in judicial review may approximate more closely the preferred level of regulation within the legal framework established by Congress. This Article does not criticize the statutory requirements governing OSHA's regulation of low-exposure carcinogens; rather, it criticizes the judiciary's analytical approach to the evidence upon which OSHA relies when determining appropriate regulatory levels of low-exposure carcinogens.

This Article will examine the legal framework governing OSHA risk regulation, the scientific studies and evidence that the judiciary currently accepts for challenging or supporting this regulation, and the effect of this standard of judicial acceptance on OSHA regulation. This Article will then compare the present state of judicial analysis of scientific evidence with alternative analyses in order to determine the most effective means of promoting a level of worker safety regulation that creates the greatest benefit to society within the legal framework established by Congress.

II. Current Judicial Approaches to Scientific Evidence in OSHA Risk Assessment Cases

A. The Statutory Framework for OSHA Regulation of Toxic Substances

The Occupational Safety and Health Act (OSH Act) of 1970(fn9) seeks to "assure so far as possible every working man and woman in the Nation safe and healthful working conditions."(fn10) Unlike other federal environmental regulatory agencies where rulemaking procedures are governed by the notice and comment requirements of the Administrative Procedure Act,(fn11) OSHA must have a hearing with cross-examination before it can promulgate rules.(fn12) In order to attain the goal of safe and healthful working conditions, Congress gave the Secretary of Labor the power to promulgate occupational safety and health standards, which must be "reasonably necessary or appropriate to provide safe or healthful employment and places of employment."(fn13) If the standard involves a toxic material or harmful physical agent, it is to be set at the level that "most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity."(fn14) The Secretary's determinations are conclusive if "supported by substantial evidence in the record considered as a whole."(fn15) The seminal case interpreting the OSH Act's standard for regulation of toxics is Industrial Union Department, AFL-CIO v. The American Petroleum Institute,(fn16) which is commonly known as the Benzene case.

B. The Benzene Case

In the Benzene case, the Supreme Court held that OSHA's regulation lowering the exposure levels for airborne benzene from a previously allowed exposure level of 10 ppm (parts per million) to a proposed level of 1 ppm was an invalid exercise of administrative discretion under the OSH Act. A four judge plurality made up of Justices Stevens, Stewart, Burger, and Powell held that the OSH Act required the Secretary of Labor to make specific determinations and presumably held that OSHA's evidence did not show a significant risk at a level to be regulated. In other words, in order to regulate a toxic material or harmful agent, the Secretary must determine that a significant risk exists at the present exposure level and that this risk can be alleviated by the proposed change in the exposure level.(fn17) Justice Rehnquist, concurring in the result and thereby completing the majority needed to overturn OSHA's action, found that the OSH Act was invalid as an impermissible delegation of legislative power to the Secretary of Labor. In Justice Rehnquist's interpretation, the OSH Act provided the Secretary with no guidance on where to set a regulatory standard.(fn18) In a spirited dissent, Justices Marshall, Brennan, White, and Blackmun attacked the plurality opinion's interpretation of what constitutes substantial evidence for purposes of regulation.(fn19)

The Benzene case and the later Cotton Dust case(fn20) dictate a two pronged approach to health regulations promulgated under the OSH Act.(fn21) First, OSHA must show that the proposed standard will cause a reduction of a "significant risk" specifically at the level being regulated.(fn22) Second, the agency must show that the proposed standard is feasible from an economic and technical point of view.(fn23) What the Benzene Court was less clear about, and what this Article examines, is the proper judicial analysis of scientific evidence upon which OSHA may rely in meeting the first prong of this test. In other words, the Benzene Court did not make clear the kinds of studies that will constitute "substantial evidence" to establish that there will be a reduction of a significant health risk.(fn24) OSHA's findings are conclusive only if "supported by substantial evidence in the record considered as a whole."(fn25) However, in judicial analysis of OSHA regulation of low-exposure carcinogens, it is difficult to determine what constitutes "substantial evidence."

The Benzene Court did not define "substantial evidence" directly. However, the Benzene case must be regarded as the critical case in determining what constitutes "substantial evidence" for low-exposure carcinogen regulation. Benzene is the only case in which the Supreme Court has examined evidence relied upon by OSHA in the regulation of low-exposure carcinogens. Moreover, when interpreting "substantial evidence" in low-exposure carcinogen cases, other federal courts have relied on the Benzene Court's standard.(fn26) The Benzene Court never specifically defined "substantial evidence." However, examination of the studies offered by OSHA in that case as evidence of the need for exposure reduction and the Benzene Court's general approach and rejection of these studies provide a useful picture of the Court's conception of "substantial evidence."

The Benzene Court's analysis included an evaluation of the studies relied on by OSHA in formulating its benzene standard. OSHA considered both the nonmalignant and malignant (carcinogenic) effects of benzene in establishing its standard for occupational exposure to airborne benzene.(fn27) In determining benzene's malignant effects, OSHA relied primarily upon studies of epidemiologic data. However, the Court found these studies flawed in two respects. First, some studies measured the impacts of benzene at a level higher than the level regulated. Second, the other studies demonstrated effects from exposure within the regulated range but in the presence of other possible carcinogens.(fn28) The agency did not construct a dose response curve in which estimates of risks at lower exposures are derived from higher exposure levels, because it claimed...