"Risk Analysis in the Courts: A Roadmap for Risk Analysts"
Menu of 1998 Full-text Online Casebook
Poster 17a
JUDICIAL REVIEW OF REGULATORY ACTION
Generally Applicable Regulations
SETTINGS
All of the basic pollution and toxic substances statutes C air pollution, water pollution, solid and hazardous waste, pesticides, industrial chemicals -- require EPA to promulgate regulations to implement Congress' wishes. EPA justifies its regulation of toxic substances (primarily carcinogens) with the use of some form of risk analysis, preferably quantitative risk assessment.
FUNCTIONS OF RISK ANALYSIS
Estimating safe doses and margins of safety
Identifying exposure pathways and relative contributions
SPECIAL CHALLENGES FOR RISK ANALYSIS
Generalizing Data
Protecting the Most Sensitive Group
Cumulative Risks
Uncertainties
Unrealistic or Unsupported Assumptions
Extrapolations
RANGE OF JUDICIAL RESPONSES
Confrontation
Flue‑Cured Tobacco Cooperative Stabilization Corp. v. EPA, 4 F. Supp 2d 435 (M.D.N.C.1998).
In Flue‑Cured Tobacco, the other shoe finally dropped on EPA's risk assessment for environmental tobacco smoke (ETS). The EPA report both characterized ETS as a human carcinogen and estimated exposure levels and associated risks. The district court in Winston‑Salem, N.C., had decided in 1994 that the risk assessment perse was reviewable as a final agency action. In the 1998 decision, the court "vacated" several chapters of the report. The court undertook an unusually searching examination of EPA's risk assessment methods and analytical techniques, and it found several inconsistencies with EPA's Risk Assessment Guidelines and internal inconsistencies in the report itself. The tobacco
industry's detailed critique was compounded by several internal EPA criticisms of the report's methods, and by a recurring failure of the report to explain (at least to the court's satisfaction) the use of different techniques at different points in the analysis and decisions to include or exclude certain data. [Applegate]
Asbestos Information Association v. Occupational Safety and Health Administration, 727 F.2d415 (5thCir. 1984).
OSHA attempted to set a sixth month emergency standard for workers' exposure to asbestos. In staying the emergency standard, the Fifth Circuit held that the urgency of the standard was not established because of the numerous uncertainties in the agency's risk assessment. Although "[t]he Agency need not support its conclusion 'with anything supporting scientific certainty'" (citing Benzene), the court rejected OSHA's risk assessment as too "speculative" because it attempted to make death predictions for only a six month period. "Indeed, OSHA concedes some unreliability and uncertainty to be inherent in risk assessment generally. Applying the risk assessment process to a period of six months, one‑ninetieth of OSHA's estimated working lifetime, only magnifies those inherent uncertainties." Id. at 426. The court also noted that contrary to OSHA's calculation that the six‑month emergency standard might prevent 80 asbestos‑related cancer deaths during that period, the agency's own data could be recalculated to predict that only about 14 deaths would be prevented during the six month emergency period. Id. at 419 n.8. [Wagner]
Avoidance
Texas Independent Ginners Association v. Marshall, 630 F.2d398, 409 (5th Cir. 1980).
OSHA attempted to set cotton dust exposure standards for the ginning industry. In validating OSHA's standard, the court concluded that OSHA had not produced "substantial evidence" for its standard. Instead, OSHA's standard was based only on extrapolating risks from one type of work place setting (cotton manufacturing) to the ginning industry which involved significantly different exposure levels and conditions. Citing Benzene, the court held that "'assumptions are not a proper substitute for the findings of a significant risk of harm required by the Act.'" Id. at 409. [Wagner]
AFL‑CIO v. OSHA, 965 F.2d 962 (11th Cir.1992).
Can a government agency set permissible exposure levels (PELs) for 428 toxic substances without specific, substantial evidence, relying instead on consensus levels among scientists? AFL‑CIO v. OSHA involved the Occupational Safety and Health Administration's (OSHA's) Air Contaminants Standard, where the agency set PELs for 428 potentially toxic substances at once. This was accomplished by "generic" rulemaking; substances were grouped into 18 categories by their primary health response, such as neuropathic effects, sensory irritation, and cancer. The agency explained:[I]t would take decades to review currently used chemicals [individually] and OSHA would never be able to keep up with the many chemicals which will be newly introduced in the future. The 11th Circuit, however, believed the PEL for each substance must stand independently; each PEL must be supported by substantial evidence and be accompanied by adequate explanation. The court adhered to the U.S. Supreme Court's standard adopted in the Benzene case, 100 S.Ct. at 2870‑71, which holds that the agency has . . . no duty to calculate the exact probability of harm [or] to support its finding that a significant risk exists with anything approaching scientific certainty. OSHA is required to at least estimate actual risk associated with a particular substance. Also at issue was OSHA's use of safety factors to make a standard stricter than the levels at which available evidence shows no significant health risk. The basis is the possibility the evidence is incorrect or incomplete, thus conceding that existing evidence does not adequately show the extent of risk. The agency merely observed how it is "customary" to set a PEL by applying a safety factor between 10 and 100 to the lowest level at which adverse effects had been observed. The court cited the lesson of Benzene that OSHA may use assumptions only to the extent they have some basis in reputable scientific evidence. If a standard should be more stringent than even a conservative interpretation of the existing evidence, then additional evidence must be acquired to support a more protective limit. The 11th Circuit vacated and remanded the rule for OSHA to make specific findings with respect to each substance. OSHA had based its rule on epidemiological or toxicological studies or, in their absence, simply adopted what it called "consensus levels" among scientists. The court applied the "harder look" doctrine to meet a statutory requirement in the Air Contaminants Standard of "substantial evidence," instead of the more deferential arbitrary and capricious standard under the Administrative Procedures Act (APA). This case presents at least two major implications for risk analysis: (1) Regulation by classes of chemicals cannot be supported using a "generic" approach to risk assessment; and (2) the convention of using safety factors in risk assessment to superimpose conservative health risk policy on scientifically derived LOAELs (Lowest Observable Adverse Effects Levels) for noncarcinogens may not survive judicial review.[Roth‑Nelson]
Deference
Public Citizen Health Research Group v. Tyson, 796 F.2d 1479, 1489, 1495 (D.C. Cir. 1986).
Taking the epidemiological and experimental studies together, OSHA found that EtO causes cancer in laboratory animals and poses a significant cancer risk for humans. While each study individually may not be a model of textbook scientific inquiry, the cumulative evidence is compelling... While some of OSHA's evidence suffers from shortcomings, such incomplete proof is inevitable when the Agency regulates on the >frontiers of scientific knowledge.' A reasonable person could draw from this evidence the conclusion that exposure to EtO presents a risk of cancer. Thus, the substantial evidence test is met, even if a reasonable person could also draw the opposite conclusion."
Poster 17b
Risk Reform Legislation
For several years, Congress has considered bills to require agencies to rely more heavily on risk assessment and to regulate their procedures for conducting risk assessments. "Risk reform" was a prominent feature of the Republican "Contract with America" in the 104th Congress (1995‑96) (H.R.9, H.R. 1022, S. 333, S. 343), but that Congress was only able to pass a couple of modest measures like changes to the Safe Drinking Water Act (42 U.S.C. 300g‑1(b)(3)). The Levin‑Thompson bill (S. 981) in the just‑ended 105th Congress represented a bipartisan compromise, but it, too, was unable to pass the Senate. The legislation has many important elements, including the role that the courts are to play in reviewing risk assessments. Some proposals would have made risk assessments review able independently of the regulatory action they supported and would have encouraged rigorous scrutiny of the assessors' conclusions and analysis. The compromise versions most likely to pass would make risk assessments part of the whole record upon which the agency's action is evaluated, place judicial review at the end of the regulatory process (i.e., after final agency action), and set the standard of review at the level of scrutiny otherwise applicable to the agency action. For the text and status of risk legislation, see www.thomas.loc.gov. [Applegate]
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Copyright © 2000.
John Applegate and Wendy Wagner.
Last modified September 28, 2000