United States District Court for the Middle District of North Carolina

“ Plaintiffs argue EPA's "biological plausibility" analysis is flawed because the Agency disregarded evidence that MS and ETS are not similar, failed to identify the criteria used in equating MS and ETS, and disregarded evidence that MS has a no-effect threshold. The importance of Plaintiffs' arguments is that the biological plausibility analysis establishes Chapter 5's "a priori hypothesis" that ETS is a Group A carcinogen. EPA uses this hypothesis to justify the use of one-tailed significance tests, which the Agency in turn relies upon to switch from a 95% to 90% confidence interval. ”

“ The basic assumption of cigarette-equivalents procedures is that the lung cancer risks in passive and active smokers are equivalently indexed by the common measure of exposure to tobacco smoke, i.e., a common value of the surrogate measure of exposure in an active and a passive smoker would imply the same lung cancer risk in both. ”

“ Mainstream smoke is the smoke inhaled by the smoker.
(21) Sidestream smoke is the smoke emitted from a smoldering cigarette between puffs.
(22) A substance is categorized as a Group A Human Carcinogen "only when there is sufficient evidence from epidemiologic studies to support a causal association between exposure to the agents and cancer." Risk Assessment Guidelines at 34,000.
Three criteria must be met before a causal association can be inferred between exposure and cancer in humans: 1. There is no identified bias that could explain the association. ”

“ As a general rule, the tobacco industry occupies that end of the spectrum contesting the carcinogenicity of ETS and EPA's motives. A committee aspiring to represent the middle of the ETS debate necessarily suppresses the tobacco industry's perspective. Further, the industry's ability to submit comments to a "neutral" committee, which itself had access to EPA, is not equivalent to industry access to EPA.
(17) In deciding whether procedural compliance could have produced a different outcome, the Marshal decision also distinguished agency action that violated the law. ”

“ EPA's study selection is disturbing. First, there is evidence in the record supporting the accusation that EPA "cherry picked" its data. Without criteria for pooling studies into a meta-analysis, the court cannot determine whether the exclusion of studies likely to disprove EPA's a priori hypothesis was coincidence or intentional. Second, EPA's excluding nearly half of the available studies directly conflicts with EPA's purported purpose for analyzing the epidemiological studies and conflicts with EPA's Risk Assessment Guidelines. ”

“ In determining whether health is affected by a pollutant, the researcher must identify whether a causal relationship exists between the pollutant and deteriorating health. Put simply, the researcher must determine how, if at all, a pollutant affects health. ”

“ Finally, when an agency conducts activities under an act authorizing information collection and dissemination of findings, the agency has a duty to disseminate the findings made. EPA did not disclose in the record or in the Assessment: its inability to demonstrate a statistically significant relationship under normal methodology; the reasoning behind adopting a one-tailed test, or that only after adjusting the Agency's methodology could a weak relative risk be demonstrated. ”

“ Chapter 5 analyzes thirty-one epidemiologic studies of nonsmoking women married to smoking spouses (spousal smoking studies) . Chapter 5 combines the spousal smoking studies data into six statistical "meta-analysis" based on geographic origin. Chapter 5 also analyzes high-exposure groups in the studies, conducts a trend analysis, and categorizes studies into four tiers based on their perceived utility for assessing an ETS/lung cancer association. The analysis within Chapter 5 utilizes one-tailed tests of significance and 90% confidence intervals. ”

“ EPA defends its Chapter 3 findings of chemical similarity by stating the Agency never suggested ETS and MS are identical compounds. Rather, EPA found that ETS and MS are similar in some respects and can be compared in terms of carcinogenicity. Differences between the compounds were not disregarded by the Agency. EPA cites to the many portions in the ETS Risk Assessment where EPA discusses the dissimilarities between MS and ETS. (FN27)
EPA asserts the Assessment specifically discusses dilution in ambient air, aging, and exposure characteristics. ”

“ Instead of explaining the criteria used to make findings, EPA's citations reveal more uncertainty. "Standardized testing protocols for assessing the physical and chemical nature of SS emissions . . . do not exist, and data on SS are not as extensive as those for MS emissions." ETS Risk Assessment at 3-2.
Although ETS is a major source of indoor air contaminants, the actual contribution of ETS to indoor air is difficult to assess due to the background levels of many contaminants contribute from a variety of other indoor and outdoor sources. ”

“ Second, the evidence consists of exposure at environmental levels people are exposed to in everyday life. EPA states such data are rare in risk assessments and obviate the need to extrapolate a response from high to low exposures. The available data being unique, EPA asserts "the guidelines themselves stress that risk analysis is not subject to hard and fast rules, but rather must be 'conducted on a case-by-case basis, giving consideration to all relevant scientific information.'" (Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J. at 47; quoting Risk Assessment Guidelines at 33,992.) ”

“ Finally, EPA defends its determination that there is no safe level of exposure to MS by referring to several studies that found a risk of lung cancer at the lowest levels of exposure to MS. EPA also relies upon SAB's finding it plausible that prolonged inhalation of ETS results in some increase of lung cancer. Finally, EPA asserts the record rebuts Plaintiffs' argument that nonsmokers are exposed only to small amounts of ETS.
3. Analysis
EPA offers three assertions as the foundation for its biological plausibility hypothesis. ”

“ When Congress requires specific procedures, agencies may not ignore them or fashion substitutes. (FN16)
A congressional directive to consult an advisory committee is more than a formality. The Court of Appeals for the District of Columbia emphasized the significance of advisory committees in explaining the procedural requirements within the Federal Coal Mine Health and Safety Act of 1969:
The most important aspect is the requirement of consultation with knowledgeable representatives of federal and state government, industry and labor. ”

“ Office Director Terry Harvey also concluded that the ETS Classification's analysis violated EPA's Risk Assessment Guidelines: " [l] ike it or not, EPA should live within its own categorization framework or clearly explain why we chose not to do so." (FN34)
In summary, Plaintiffs raise legitimate questions not addressed in the record regarding EPA's bioplausibility theory. If confronted by a representative committee that voiced industry concerns, EPA would likely have had to resolve these issues in the record. It is not clear whether EPA could have or can do so. ”

“ EPA also claims that workplace exposure data were disregarded because only two studies made an attempt to classify by amount of exposure. Again, EPA's explanation appears nowhere in that portion of the Risk Assessment cited by the Agency. Further, EPA's explanation appears targeted only at workplace data contained within the spousal smoking studies and does not address the Agency's decision to disregard workplace and childhood exposure data reported outside spousal studies. ”

“ Review of Draft Passive Smoking Health Effects Document, EPA/SAB/IAQC/93/003, at 11, November 20, 1992.
(28) [S] ome persons suggest a dosimetric approach (called "cigarette-equivalents" in the Report) to estimate lung cancer risk from ETS exposure from data on active smoking. An average ETS exposure is determined to be equivalent to actively smoking some percentage of one cigarette per day. Extrapolating downward on a does-response [sic] curve for active smoking at that level suggests a negligible" lung cancer risk. ”

“ Plaintiffs initially argue that had industry been consulted during the research process, EPA likely would not have conducted a risk assessment and carcinogen classification. Plaintiffs' argument depends on the ETS Risk Assessment being ultra vires. As already addressed, risk assessment is incidental to gathering information, researching, and disseminating the findings. ”

“ EPA explains that its biological plausibility findings rest on three considerations. First, active smoking causes lung cancer in humans, and MS is chemically similar to ETS. Second, considerable evidence exists that nonsmokers exposed to ETS absorb and metabolize significant amounts of ETS, including carcinogenic compounds. Third, laboratory studies show ETS can cause cancer in animals and damage DNA, which scientists recognize as being an instrumental mechanism for cancer development. ”

“ EPA asserts that if the substance is identified as a hazard, the second question is a quantitative assessment as to how dangerous a carcinogenic substance is to humans. See id. (Quantitative risk assessment is a general term to describe all or parts of dose-response assessment, exposure assessment, and risk characterization.) ”

“ EPA further revealed that such differences affect carcinogenicity; "Pipe and cigar smokers, who inhale less deeply than cigarette smokers, have lower risks of lung cancer than cigarette smokers." Id. at 4-10.
In a draft response to comments, Kenneth Brown, the primary author of Chapters 5 and 6, and Appendices C and D, rejects using a cigarette-equivalents analysis because "there are differences between active and passive smoking that may affect carcinogenic risk that are not fully understood." ”

“ There is no just reason for so delaying final judgment regarding EPA's ETS Risk Assessment. However, Plaintiffs' new allegations are significantly related to the Complaint. Precedent as well as principles of judicial economy and justice urge the court to allow Plaintiffs' motion. To cure this dilemma, the court will allow Plaintiffs to serve their supplemental pleading and will sua sponte make an express direction for the entry of judgment regarding the parties' motions for summary judgment. Accordingly, the court's judgment will be certified for review pursuant to Fed. ”

“ EPA also relies upon IAQC's finding:
there are substantial differences in the relative composition of the smoke formed between mainstream and sidestream smoke, . . . but there is no reason to suppose that the qualitative toxicities of ETS and MS are substantially different. In comparing these two agents, the differences are largely ones of dose and duration of exposure rather than fundamental differences in the toxicity or carcinogenicity of the agent in question. ”

“ So useful they are and of such service in the efficient administration of justice that they ought to be allowed as of course, unless some particular reason for disallowing them appears, though the court has the unquestioned right to impose terms upon their allowance when fairness appears to require them. ”

“ The studies EPA reviewed showed measurable carcinogens and toxins in ETS at levels that varied but consistently exceeded background levels. Second, EPA reviewed biomarker studies which showed at least some of the carcinogens in ETS are absorbed by the body at a higher rate than nicotine. The human carcinogen 4-aminobiphenyl (4-ABP) , which is emitted at concentrations 31 times greater in SS than MS, was present in the blood of nonsmokers exposed to ETS in concentrations of one-tenth to one-fifth of that found in active smokers. ”

“ Given the ETS Risk Assessment shortcomings already discussed, it is neither necessary or desirable to delve further into EPA's epidemiological web. However, two of Plaintiffs' arguments require mention. (FN36) The first contention is EPA switched, without explanation, from using standard 95% confidence intervals to 90% confidence intervals to enhance the likelihood that its meta-analysis would appear statistically significant. This shift assisted EPA in obtaining statistically significant results. Studies that are not statistically significant are "null studies" ”

“ EPA's conduct raises several concerns besides whether a relative risk of 1.19 is credible evidence supporting a Group A classification. First, with such a weak showing, if even a fraction of Plaintiffs' allegations regarding study selection or methodology is true, EPA cannot show a statistically significant association between ETS and lung cancer. ”

“ E.L. Wynder & G. C. Kabat, Environmental Tobacco Smoke and Lung Cancer: A Critical Assessment, ORD.C.1 S59-1 (JA 5,020) . Nowhere in the Assessment is there a suggestion that childhood exposure data should be ignored.
EPA claims it excluded the latest two U.S. spousal smoking studies because they were submitted after the close of the comment period, and EPA already had a considerable database. EPA claims the Fontham study was used because it published interim results, was the largest U.S. ETS study, and its methodology was superior to any other study. ”

“ EPA also failed the Act's procedural requirements. In the Radon Research Act, Congress granted EPA limited research authority along with an obligation to seek advice from a representative committee during such research. Congress intended industry representatives to be at the table and their voices heard during the research process. EPA's authority under the act is contingent upon the Agency hearing and responding to the represented constituents' concerns. ”