The Osteen Decision

The Osteen Decision

July 17, 1998
Page 2 of 3 pages: |1|3|
pages 30-61
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C. The Timing of Committee Formation

EPA argues that 403(c) is generally worded and does not make the formation of a representative advisory committee a prerequisite that must be satisfied before EPA can undertake a specific activity under the Act. There is no evidence in the record, nor does EPA argue, that EPA established the committee during or after any activity conducted under the Act. Since the committee has not been established, EPA's argument about when it could have sought the committee's assistance appears academic. However, for purposes of fashioning a remedy, 403(c) requires EPA to seek the committee's assistance "in carrying out the research program . . . . Congress intended consultation at least while EPA conducted research. ongoing consultation requires more than post hoc consultation. See Morabito v. Blum, 528 F. Supp. 252, 264- 66 (S.D.N.Y. 1981) (Under the Social Security Act, where consultation with a medical advisory committee is required, committee input must be sought and received before action is taken.).

D. Consequences of EPA's Procedural Failure Plaintiffs argue EPA's actions were unlawful and the ETS Risk Assessment must be set aside. EPA argues Plaintiffs

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were not prejudiced "because EPA in fact utilized extensive public participation and peer review drawing upon all of the designated constituencies in developing the ETS Risk Assessment." (Conformed Mem. Sut; (Conformed drawing upon all of the designated constituencies in developing the ETS Risk Assessment." (Conformed Mem. Sut; (Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J. at 42-43.) Further in its memorandum, however, EPA maintains it did "not have an obligation to respond to public comments in the same manner as in [an APA] section 553 rulemaking," id. at 49, and the court cannot require EPA to respond to comments because "reviewing courts are generally not free to impose additional procedural requirements if the agencies have not chosen to grant them." Id.

Even if EPA did provide a genuine opportunity for comment and SAB review, the Agency was required to carry out its research program with the assistance of an advisory group of representatives of the identified interests. EPA may not rewrite the terms of the Radon Research Act. See Environmental Defense Fund. Inc. v. EPA, 636 F.2d 1267, 1283-84 (D.C. Cir. 1980) (agency-created -de minimis" cutoff from application of statute was struck down because not in compliance with terms of statute); Alabama Power Co. v. Costle, 636 F.2d 323, 365 (D.C. Cir. 1979) (The agency is not "free to ignore the plain meaning of the statute and to substitute its policy judgment for that of

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Congress."). When Congress requires specific procedures, agencies may not ignore them or fashion substitutes. 16 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. This goes far beyond the usual requirements of public notice and opportunity for comment set forth in the Administrative Procedure Act, and represents the Congressional answer to the fears expressed by industry and labor of the prospect of unchecked federal administrative discretion in the field. These rather unique requirements of the Act are an important part of the ultimate legislative compromise, and must be given their due weight.

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16 Even so, the IAQC was a poor proxy for industry representation. EPA sought parties near the "middle" of the spectrum when establishing SAB panels and allegedly avoided representation from either end of the spectrum. 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, industry's ability to submit comments to a "neutral" committee, which itself had access to EPA, is not equivalent to industry access to EPA.

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Zeigler Coal Co. v. Klelppe, 536 F.2d 398, 403 (D.C. Cir. 1976). In National Constructors Ass'n v. Marshal, 581 F.2d 960 (D.C.Cir. 1978), the Secretary of Labor was obligated to establish and consult with a specially constituted advisory committee when promulgating safety standards. The Secretary failed to do so. The Marshal court rejected the agency's effort to equate notice and comment with the required procedures and concluded that "advisory committee consultation should, but in this case did not, consist of something more than a . . . rest stop on the route between a tentative proposal,. and the final promulgation Id. at 971.

EPA relies on Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 558, 98 S. Ct. 1197, 1219, 55 L. Ed. 2d 460 (1978). In Vermont Yankee, the agency complied with statutory procedures, but the appeals court held the agency should have done more. The Supreme Court reversed, noting "we find absolutely nothing in the relevant statutes to Justify what the court did here." Id. at 557, 98 S. Ct. at 1218. In the present action, EPA violated a statutory procedure.

At issue then is the proper remedy for agency action that is procedurally deficient. Specifically, the court must determine whether to vacate the ETS Risk Assessment. In Vermont Yankee,


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the Court held "[aldministrative decisions should be set aside . . . only for substantial procedural or substantive reasons as mandated by statute Id. at 558, 98 S. Ct. at 1219.

In Synthetic Organic Chem. Mfrs. Ass'n v. Brennan, 506 F.2d 385, 388-89 (3d Cir. 1974), Congress gave the Secretary of Labor the option of requesting recommendations from an advisory committee prior to promulgating certain rules. If the Secretary used the committee, interested parties could submit their comments about the rule after the committee issued its report. The dispute before the Third Circuit arose when the Secretary consulted the committee but published a proposed rule before the advisory committee submitted its report. The complainants "were not given adequate time to submit comments or to prepare for the hearing after the committee's work was completed." Id. at 388. The court remanded the standards to the agency with the directive to republish them and follow the procedural requirements.

In Marshal, 581 F.2d 960, the agency was required to consult an advisory committee before promulgating the disputed standards. The court found the agency greatly deviated from required procedures and agency regulations by not meaningfully consulting the committee. The court concluded that, had the agency abided by its procedural requirements, the agency may have promulgated

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different standards. Accordingly, the court remanded the standards back to the agency for consultation with the advisory committee. Because the court also found the standards as promulgated were not illegal and the administrative record did not contain any glaring deficiencies, the court ordered a minimum remand of ninety days during which the standards would remain in effect. If the committee recommended alteration, the agency would have to reevaluate the standards.

In Brennan and Marshal, the agencies failed procedural requirements in the process of promulgating agency standards. In both Brennan and Marshal, the courts remanded the disputed agency standards with directives to comply with the procedural directives. The Marshal decision left the standards intact; the Brennan decision did not.

This case is similar to Brennan and Marshal in that the ETS Risk Assessment constitutes an agency characterization promulgated without adherence to statutory procedure. However, this case is also unique. First, it is quite clear that the ETS Risk Assessment consumed significantly more resources than the promulgation of standards in Brennan and Marshal. Second, Congress' procedural requirements in the Radon Research Act adhere to the research process. Remanding the ETS Risk

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Assessment for post hoc consultation could not satisfy statutory requirements of consultation during research.

To satisfy the Radon Research Act's procedural requirements, the court would have to vacate the Assessment. EPA could then conduct research on ETS with the assistance of a representative committee. However, in Vermont Yankee, the Supreme Court advised that agency action should be set aside only for substantial reason. By itself, disregarding a statutory mandate to establish and consult an advisory committee is substantial. Again, EPA expended significant resources over several years in producing an assessment which claimed to deal with public health and safety. The Assessment's subject matter and EPA's expenditures raise the threshold of what constitutes a substantial reason.

EPA's complete disregard of statutory procedure and the potential waste of significant executive branch resources dealing with health and safety each suggest a different remedy. In resolving this conflict, the court finds persuasive the rationale underlying the District of Columbia's remedy in Marshal. In addition to enforcing Congress' directive, the remedy should ameliorate the harm caused, or being caused, by EPA's procedural

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violation." The court is reluctant to characterize EPA's procedural deficiency substantial where EPA would simply reproduce the same ETS Risk Assessment at significant cost. In resolving the substantiality of EPA's procedural defect, the court must inquire whether EPA's procedural failure affected the Assessment. See Textile Workers Union of-America v. Lincoln Mills of Alabama, 353 U.S. 448, 457, 77 S. Ct. 912, 918 (1957) (Some federal law "lack[s] express statutory sanction but will be solved by looking at the policy of -..'ie legislation and fashioning a remedy that will effectuate that policy. The range of judicial inventiveness will be determined by the nature of the problem."); United States v. Field, 193 F.2d 92, 96 (2nd Cir. 1951) ("'[I]t is fundamental that federal courts, in common with other courts, have inherent power to do all things that are reasonably necessary for the administration of justice, within the scope of their jurisdiction.,")

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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 procedural failure constitutes a violation of the law. Where significant agency resources are at stake, the court will not, however, adopt a formal, bright line rule.

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V. THE ENVIRONMENTAL TOBACCO SMOKE RISK ASSESSMENT

A. Overview


The court reviews the performance of the ETS Risk Assessment to determine whether consultation with the representative group would have likely produced a different result.
18 19.

Chapter 1 summarizes the claim that ETS is a Group A carcinogen that causes approximately 3,000 lung cancer deaths per

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18 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.

19 The parties' arguments to the court address whether EPA's conduct was arbitrary and capricious and whether the record demonstrates reasoned decision making. The court uses the arguments to determine whether the Assessment would have been different had industry (and state) representatives addressed their concerns directly to EPA. The inquiry turns on the legitimacy of Plaintiffs, concerns.

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ETS Risk Assessment at 2-7 thru 2-8. The report then states that although ETS and MS are chemically similar, "ETS is rapidly diluted into the environment, and consequently, passive smokers are exposed to much lower concentrations of these agents than are active smokers." Id. at 2-8.

Chapter 3 establishes that ETS and MS are chemically similar because: (a) ETS is composed of aged, diluted sidestream smoke (SS),
21 and aged, diluted, exhaled MS, and (b) fifty-two of the 4,000+ characterized chemical constituents of MS were found in SS, which include most of the suspected carcinogens identified in Ms.

Chapter 4 states that the high relative risks (RR) for lung cancer associated with active smoking along "with no evidence of a threshold level of exposure,"
id. at 2-9, the chemical similarity between MS and ETS, and corroborative evidence for the carcinogenicity of tobacco smoke provided by animal bioassay and genotoxicity studies "clearly establish the biological plausibility that ETS is also a human lung carcinogen." Id. at 2- 9; see also 4-27 thru 4-29. EPA asserts these observations

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21 Sidestream smoke is the smoke emitted from a smoldering cigarette between puffs.

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alone are sufficient to establish ETS as a Group A carcinogen designation 22

Chapter 4 concludes with recognition that EPA should examine the "vast body of epidemiologic data dealing specifically with lung cancer and exposure to ETS." Id. at 4-29. The chapter concludes this data should be examined: (1) to promote "the interest of weighing all the available evidence, as recommended by EPA's [Risk Assessment Guidelines] (2) because SS and MS rapidly dilute into the environment and ETS components change phase distributions over time, which raises questions about the carcinogenicity of ETS exposure under environmental conditions, and (3) since "active smoking data do not constitute a good basis for quantitative estimation of the health effects of passive

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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. 2. The possibility of confounding has been considered and ruled out as explaining the association. 3. The association is unlikely to be due to chance.

Id. at 33,999.

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smoking because the relative uptake and deposition between active and passive smokers of the agent(s) responsible for these effects are not known Id.

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. "The justification for this usage is based on the
a priori hypothesis [from the theory of biological plausibility] that a positive association exists between exposure to ETS and lung cancer." Id. at 5-2.

Chapter 6 conducts an exposure assessment in an attempt to quantify the threat posed by ETS. Chapter 6 concludes that MS and ETS are too dissimilar to use data about MS to assess the risks of ETS exposure.
Id. at 6-6. Chapter 6 thus bases its exposure assessment on data from the spousal smoking studies and

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asserts that ETS exposure causes approximately 3,000 nonsmoker lung cancer deaths each year."

The Addendum addresses large U.S. spousal smoking studies published in 1992. It claims "these new studies are generally consistent with this report's conclusions . . . . Id. at ADD-1. Appendix A reviews the thirty-one spousal smoking studies and explains how the studies were assigned to tiers based on their perceived utility. Appendix B explains how EPA adjusted the data used in Chapter 5's meta-analysis to address the effects of smoker misclassification bias.,

There are two issues. The first is whether EPA's consulting a representative committee, on which industry's concerns were represented during the research process, likely would have caused EPA to change the conduct or conclusions of its ETS assessment. The key to this determination is whether industry representatives could have presented meritable criticism and advice. The second issue is whether EPA's conduct was otherwise in accordance with the Radon Research Act.

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23 Chapters 7 and 8 do not involve the carcinogenicity of ETS.

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B. Biological Plausibility

1.
Industry Criticism

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.

Plaintiffs assert the record does not explain why EPA ignored record evidence and EPA's own findings in the chemical similarity analysis of Chapter 3. Plaintiffs point out that EPA analyzed the similarity of MS and ETS three times and reached three different conclusions. Chapter 6 establishes ETS and MS were too dissimilar to use MS data to establish the carcinogenic risk of ETS, and Chapter 2 states the similarity of ETS to MS was too indeterminate to assess risk according to EPA's Guidelines for the Health Risk Assessment of Chemical-Mixtures. Chapter 3, however, uses the chemical similarities of ETS and MS to

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establish ETS as a known human carcinogen. Plaintiffs argue Chapter 3's similarity analysis fails for three reasons: (1) the chapter ignored Assessment findings about the differences between MS and ETS; (2) EPA ignored evidence rejecting any chemical similarity; and (3) EPA did not define the criteria used to reach conclusions about the similarity/dissimilarity/indeterminacy of MS and ETS.

Plaintiffs point out Chapter 3's similarity analysis is contradicted by the explanation at the end of Chapter 4 for analyzing epidemiologic data. Specifically, "[t]he rapid dilution of both SS and exhaled MS into the environment and changing phase distributions of ETS components over time raise some questions about the carcinogenic potential of ETS under actual environmental exposure conditions." ETS Risk Assessment at 4-29.

in rejecting using a "cigarette-equivalents" correlation, Chapter 2 states that although MS and ETS are qualitatively similar, the absolute and proportional quantities of the components, as well as their physical state, differ substantially. EPA also rejects this equivalents analysis because it does not know which tobacco smoke chemicals cause cancer nor the effect metabolic differences between active and

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passive smokers have on carcinogenicity. See id. at 2-7 thru 2-9. Chapter 6 bases its rejection of an equivalents analysis on the differences between MS and SS:

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. This assumption may not be tenable, however, as MS and SS differ in the relative composition of carcinogens and other components identified in tobacco smoke and in their physicochemical properties in general; the lung and systemic distribution of chemical agents common to MS and SS are affected by their relative distribution between the vapor and particle phases, which differs between MS and SS and changes with SS as it ages. Active and passive smoking also differ in characteristics of intake . . . which may affect deposition and systemic distribution of various tobacco smoke components as well. Id. at 6-6. 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

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risk that are not fully understood." Kenneth G. Brown, Draft Report Responses to Public Comments on the First
EPA Draft Risk Assessment of ETS with Discussion of Revisions that Appear in the Second Draft Report,
Response To Comment 3.1.4, at 16 (June 1992) (JA 6,457) (Draft Responses). The author agrees "that active and passive smoking are vastly dissimilar with regard to exposure," id., and states,

[a]lthough it would be of interest to know more about the physicochemical properties of ETS, the distribution of exposure concentration, exposure duration, and other characteristics, these things do not need to be fully understood to conclude that
ETS is a carcinogen . . . . If the unknown characteristics regarding the properties of ETS or exposure to ETS nullified the carcinogenic potential in fresh sidestream smoke, then we would not expect to see an association of ETS exposure with increased lung cancer, as the study data indicate.

Id., Response To 3.1.2, at 14 (JA 6,455).

Plaintiffs assert EPA's statements impact EPA's biological plausibility analysis. Regarding EPA's a priori hypothesis, Plaintiffs conclude: (1) ETS cannot be a known carcinogen if dilution and aging raise unresolved questions about its potential carcinogenicity, and (2) ETS and MS are not "sufficiently similar" carcinogens if they are "vastly dissimilar" as to exposure.

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Plaintiffs next point to comments submitted by scientists 24 and by the tobacco industry citing scientific literature
21 that reject EPA's similarity conclusions. Plaintiffs contend EPA selectively cites or ignores certain studies, depending on whether the Agency is explaining or disclaiming similarities between ETS and MS. Plaintiffs also point out that none of the eleven U.S. epidemiologic studies analyzed in the ETS Risk Assessment, as reported by their authors, shows an overall statistically significant association between ETS and lung cancer.

Plaintiffs also argue EPA failed to identify the criteria used to determine chemical similarity. Plaintiffs insist the criteria EPA-used to analyze similarity must be precise for two reasons. First, at different times in the same ETS Risk Assessment, EPA concluded that MS and ETS are similar,

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24 See, e.g., Comments of Cronan (JA 6,188); Comments of Gori (JA 10,839); Comments of Todhunter (JA 10,072); Comments of Flamm (JA 10,633-34); Comments of Newell (JA 10,660-61); Comments of Reasor (JA 10,786).

25 See, e.g., Comments of The Tobacco Institute (JA 9,537-38, 9,543); Comments of Reasor (JA 10,789-90); Comments of R.J. Reynolds (JA 5,841-58); Comments of Philip Morris (JA 10,012, 10,024).

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dissimilar, and of indeterminate similarity . 26 Second, EPA's chemical similarity analysis is inconsistent with the Agency's prior risk assessment practices. See Risk Assessment Guidelines at 33,992 (listing "consistency of carcinogen risk assessments" as an EPA goal). Plaintiffs then provide evidence that., previously, EPA did not classify agents in Group A because they contain the same constituents as other Group A carcinogens. See Tennessee Gas Pipelines Co. v. F.E.R.C., 926 F.2d 1206, 1211 (D..C. Cir. 1991) (When an agency decision is inconsistent with prior decisions, it must explain the change.).

As their final argument against EPA's biological plausibility hypothesis, Plaintiffs dispute EPA's conclusion that ETS exposure causes lung cancer because "[a] clear dose- response relationship exists between lung cancer and amount of exposure [to MS], without any evidence of a threshold level." ETS Risk Assessment at 4-1. EPA's "no threshold" finding means EPA

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26 See Dithiocarbamate Task Force v. EPA, 98 F.3d 1394, 1404-05 (D.C. Cir. 1996) (vacating EPA's listing of a carbamate as a "K waste" because EPA could not employ a highly discretionary and unarticulated "environmental concern" standard and then fail to explain why that carbamate failed to meet that standard); see also Toler v. Eastern Assoc. Coal Co., 43 F.3d 109, 115-16 (4th Cir. 1995) (review of denial of medical benefits, requiring an ALJ to identify specific and persuasive reasons to justify seemingly paradoxical reasoning).

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purported to find no concentration level at which MS ceases to be carcinogenic. This finding was critical because Plaintiffs assert that nonsmokers are exposed to only minute concentrations of ETS. If EPA had found a threshold for exposure to MS, then one would have to be established for ETS. Evidence of an MS exposure threshold would jeopardize EPA's biological plausibility analysis since ETS is substantially more dilute than MS. Plaintiffs point to comments and evidence in the record of thresholds in human, animal, and genotoxicity studies. Again, Plaintiffs point to EPA's selective use of studies and failure to consider or respond to contrary evidence.

2. EPA's Response

In response to Plaintiffs, claim that EPA failed to respond to certain public comments, EPA asserts that it did not have an obligation to respond to public comments in the same manner as in formal rulemaking. EPA further reminds that it is not the province of the court to impose additional procedural requirements outside those mandated by Congress.

In assessing the health risk of ETS, EPA claims it used a "total weight of the evidence" approach, see Risk Assessment Guidelines at 33,996, 33,999-34,000, and the Agency's conclusions

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rely upon all of the available evidence, not on any single analysis or theory. EPA offers two reasons the ETS Risk Assessment is unique. First, the database of evidence concerning ETS is large and derived from human data. "The use of human evidence eliminates the uncertainties that normally arise when one has to base hazard identification on the results of high-dose animal experiments." ETS Risk Assessment at 2-7. 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.)

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

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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. Further, EPA argues that its bioplausibility theory alone need not be sufficient to support the Assessment's conclusion, because the theory is confirmed by the findings from the epidemiologic studies.

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

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27 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 substantively 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.

(continued...

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EPA asserts the Assessment specifically discusses dilution in ambient air, aging, and exposure characteristics. Review of EPA's citations reveals very limited discussion. The discussions primarily admit that these are areas of uncertainty. See ETS Risk Assessment at 3-10 ("Detailed chemical characterizations of ETS emissions . . . are limited. As a result, the impact on ETS of factors such as the rapid dilution of SS emissions, adsorption and remission of contaminants, and exhaled MS is not well understood."); see also id. at 3-12 (ETS concentration is the result of a complex interaction of at least 13 variables; studies show large variations in contaminant concentrations.). EPA asserts that despite these uncertainties, nonsmokers, lungs are nevertheless exposed to and absorb contaminants, including carcinogens, and that exposure can be at significant levels relative to active smokers.

EPA characterizes Plaintiffs, contrasting the Agency's differing conclusions on ETS-MS similarities as nothing more than obfuscating the differences between qualitative and quantitative assessments. EPA claims the first issue (hazard identification)

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27 ( ... continued)


EPA, An SAB Report: Review of Draft Passive Smoking Health Effects Document,
EPA/SAB/IAQC/93/003, at 11, November 20, 1992.

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in the risk assessment process is a qualitative determination as to whether a substance is carcinogenic. See Risk Assessment Guidelines at 33,993 ("The hazard identification component qualitatively answers the question of how likely an agent is to be a human carcinogen."). 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 also claims it explained four criteria for finding MS and ETS chemically similar: (1) the process resulting in the generation of MS and SS; (2) the identity of toxins and carcinogens in the two substances; (3) the relative toxicity and carcinogenicity of SS and MS per cigarette smoke; and (4) the demonstrated exposure to and absorption by the body of significant levels of carcinogens and other toxins. In response to the charge that it changed its approach in evaluating biological plausibility vis-a-vis other Group A carcinogen determinations, EPA states risk assessments are conducted on a case-by-case basis. Thus, comparison to other EPA Group A determinations are not relevant. EPA then re-explains the basis

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for its plausibility hypothesis and states no other EPA Group A determination involves comparison with a substance whose carcinogenicity is as potent and as well documented as MS.

EPA asserts the epidemiologic studies reviewed in Chapter 4 establish MS as a human carcinogen. In defense of chemical similarity, EPA recites the similarities between SS and MS. Both compounds contain the same carcinogenic compounds, moreover, EPA asserts "there is voluminous record evidence demonstrating that SS is more toxic per cigarette smoked than the carcinogenic MS." (Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J. at 62.)

In recognizing that ETS is rapidly diluted into the environment, EPA explains that it analyzed the extent to which nonsmokers actually absorb and metabolize ETS. First, EPA examined the extent of nonsmokers, actual exposure to ETS in a variety of indoor environments. 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

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concentrations of one-tenth to one-fifth of that found in active smokers. These studies lead EPA to conclude that nonsmokers exposed to ETS absorb and metabolize ETS, including carcinogenic compounds.

EPA asserts that Plaintiffs, arguments are simply attacks on the uncertainties inherent in the risk assessment process. A risk assessment, by its very nature, is not a final determination about the health effects of a substance but is instead an assessment that makes the best judgments possible based upon the available evidence. Ethyl Corp. v. EPA, 541 F.2d 1, 24 (D.C. Cir. 1976). In conducting risk assessments, an agency must adopt inference options and point out where evidence and scientific knowledge are incomplete. NRC Redbook, at 18, 28.

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.

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3. Analysis

EPA offers three assertions as the foundation for its biological plausibility hypothesis. Plaintiffs contest EPA's first assertion that MS and ETS are similar. In support of its second assertion, EPA points to evidence in the record that some components of ETS are absorbed by nonsmokers. EPA does not, however, direct the court to evidence in the record demonstrating that the observed absorption of ETS constituents answers the questions of carcinogenicity raised elsewhere in EPA's analysis.

There is limited evidence in the record supporting EPA's final basis for its plausibility hypothesis. The animal laboratory studies used by EPA present some evidence supporting EPA's hypothesis. EPA conducted no animal lifetime inhalation studies of ETS but did conduct cigarette smoke inhalation studies on Syrian golden hamsters. The studies detected no evidence of lung cancer but did detect evidence of cancer of the upper larynx and a dose- response relationship. The record does not state whether the substance analyzed, air-diluted cigarette smoke (1:15), replicated MS, SS, or ETS. The remaining studies, upon which EPA relies, involve analysis of SS condensates from smoking machines. The Assessment does not explain, nor does EPA direct

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the court to any evidence within the record explaining, how SS condensate demonstrates similarities between MS and ETS.

The court is disturbed that EPA and Kenneth Brown buttress the bioplausibility theory with the epidemiology studies. EPA's theory must be independently plausible. EPA relied upon similarities between MS and ETS to conclude that it is biologically plausible that ETS causes cancer. EPA terms this theory its "a priori hypothesis" in justifying Chapter 5's methodology. Chapter 5's methodology allowed EPA to demonstrate a statistically significant association between ETS exposure and lung cancer. See Federal Judicial Center, Reference Manual on Scientific Evidence 154-55, (1994) (Narrowing the confidence intervals makes it more likely that a study will be found to be statistically significant.). Chapter 5's analysis rests on the validity of the biological plausibility theory. It is circular for EPA to now argue the epidemiology studies support the Agency's a priori theory. Without the theory, the studies would likely have done no such thing.

The record also does not support EPA's argument that contrasting EPA's three positions on ETS-MS similarities constitutes obfuscation. EPA's Risk Assessment Guidelines establish a distinction between qualitative and quantitative

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analysis. However, for purposes of EPA's bioplausibility theory, neither the ETS Risk Assessment or administrative record demonstrates a difference or attempt the explanation which EPA now offers the court. Quantity versus quality may be a relevant distinction in certain situations, e.g., the amount of arsenic naturally occurring in an apple. Plaintiffs assert that since ETS is a gas, considering the evidence regarding ETS' physicochemical properties and the characteristics of the particles and gases comprising ETS is necessary to determine the quality of ETS. This suggests an analytical process combining qualitative and quantitative analysis, which is also what EPA's Risk Assessment Guidelines suggest.

EPA's Risk Assessment Guidelines do not support the Agency's argument that risk assessment is a bifurcated, quantitative then qualitative, analysis. To the contrary, "[r]isk assessment includes one or more of the following components: hazard identification, dose-response assessment, exposure assessment, and risk characterization (NRC "Risk Assessment Guidelines at 33,993 (emphasis added). "[Q]uantitative risk assessment has been used as an inclusive term to describe all or parts of dose- response assessment, exposure assessment, and risk characterization. . . . [However,] the more explicit terminology

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developed by the NRC (1983) is usually preferred." Id. Neither the Assessment or the administrative record explains why physicochemical inquiries require a bifurcated analysis instead of a combined analysis as per the Guidelines, or why MS and ETS are similar for purposes of hazard identification, but not for purposes of quantitative risk assessments. Since Chapter 2 found ETS and MS not sufficiently similar, Chapter 3 found them similar, and Chapter 6 found them dissimilar, EPA apparently used a different risk assessment methodology for each chapter. Again, neither the Assessment nor the record explains the risk assessment components used in the different chapters, why methodologies varied between chapters, or why ETS and MS were or were not similar using each methodology.

The court is faced with the ugly possibility that EPA adopted a methodology for each chapter, without explanation, based on the outcome sought in that chapter. This possibility is most potent where EPA rejected MS-ETS similarities to avoid a "cigarette- equivalents" analysis in determining carcinogenicity of ETS exposure. Use of cigarette-equivalents analysis may have lead to a conclusion that ETS is not a Group A carcinogen." It

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28 [S]ome persons suggest a dosimetric approach
(continued...

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is striking that MS and ETS were similar only where such a conclusion promoted finding ETS a carcinogen.

EPA's assertion that "EPA did explain the numerous criteria it used in assessing similarity . . . " (Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J. at 73), is without merit. EPA merely parrots the findings made in Chapter 3 of the ETS Risk Assessment. The record presents no evidence of EPA establishing similarity criteria before the Assessment
.29 Nor did the

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28 ... continued)
(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.

Kenneth G. Brown, Draft Report Responses to Public Comments on the First EPA Draft Risk Assessment of ETS with Discussion of Revisions that Appear in the Second Draft Report, Comment 3.1.4, at 15 (June 25, 1992) (JA 6,456) (Draft Responses). Dr. Brown's response does not rebut the asserted consequences of a cigarette equivalents analysis.

29
See Portland Cement Ass'n v. Ruckelshaus,
486 F.2d. 375, 395 (D.C. Cir. 1973) ("A troublesome aspect of this case is the identification of what, in fact, formed the basis for the standards promulgated by EPA - a question that must be probed prior to consideration of whether the basis or bases for the standards is reliable."); see also Independent U.S. Tanker Owners Comm. v. Lewis,, 690 F.2d 908, 920 (D.C. Cir. 1982) (noting that when agency action is undertaken prior to disclosure of the basis (continued...

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