US Supreme Court Briefs

No. 99-1257




Filed September 11th, 2000







    1. Science Describes and Explains

    2. Risk Management Prescribes

    3. Agencies Can Use Science as a "Charade"


    1. Science Alone Cannot Guide Standard-Setting for Non-Threshold Air Pollutants

    2. EPA's Exclusive Reliance on Science to Justify its Standards Creates the Appearance of a "Charade"




Amici are professors and scientists with scholarly or professional interests in the intersection of law and Science. The various amici have taught, researched, and published on issues involving law, science, and policy. Brief summaries of the qualifications and affiliations of the individual amici are provided at the end of this brief.

Amici have an interest in seeing that the Court is informed on the appropriate use and limitations of science in setting national ambient air quality standards (NAAQS) under the Clean Air Act. While amici support reliance on science to assess the risks of altemative air quality standards, science alone cannot provide a principled justification for setting such standards.

Amici file this brief solely as individuals and not on behalf of the institutions with which they are affiliated. In addition, amici take no position on the merits of the specific air quality standards at issue in this case. Rather, their views address the broader question of the role of science in the process by which the U.S. Environmental Protection Agency (EPA) sets air quality standards.1


The Clean Air Act calls for the EPA Administrator to use her "judgment" to select a primary NAAQS that is "requisite to protect the public health" based on the criteria document and allowing "an adequate margin of safety." 42 U.S.C. §7409(b)(1). The statute also specifies that the criteria document shall "reflect the latest scientific knowledge" about

1 Pursuant to Rule 37.6 of the Rules of this Court, amici state that no person or entity, other than the individual amici, authored this brief in whole or in part, or made any monetary contribution to the preparation or submission of this brief. Letters of consent to the filing of this brief from all parties have been lodged with the Clerk of the Court pursuant to Rule 37.3.

the public health and welfare2 effects of the pollutant in question. Id. § 7408(a)(2).

At every step in this proceeding, including before this Court, EPA has purported to rely exclusively on scientific factors to justify its selection of revised NAAQS for ozone and particulate matter (PM). Even though EPA appears to acknowledge in its rulemaking preambles that setting air quality standards is a "policy choice,"3 the only criteria it identifies for making such choices are scientific ones.

In its brief filed in this Court, EPA identified three types of limitations on its NAAQS rulemaking discretion which the Agency argues satisfy the "intelligible principle" requirement. Brief for Petitioner U.S. EPA, No. 99-1257, at 23-24 (July21, 2000) (hereinafter "EPA Br."). The three limitations are the criteria documents reflecting "the latest scientific knowledge," the advice from the EPA's Clean Air Scientific Advisory Committee (CASAC), and the rulemaking requirements of section 307(d) of the Clean Air Act. The latter "limitation~~ is procedural only, while the first two factors emphasize scientific inputs.

Likewise, in the NAAQS rulemakings, EPA justified the selection of its NAAQS standards based exclusively on health effects and scientific criteria. For example, EPA claimed to select its ozone standard based solely on "public health policy judgments in addition to determinations of a strictly scientific nature," with assessments of risk playing a "central role in identifying an appropriate level." 62 Fed. Reg. at 38,863 (quotation omitted). The only type of public health "policy

2 Under the Clean Air Act, "welfare" effects refer to non-human biological and physical effects, not monetary measures of impacts as economists use the term.

3 EPA, Ozone Final Rule, 62 Fed. Reg. 38,856, 38,857 (July 18, 1997); EPA, PM Final Rule, 62 Fed. Reg. 38,652, 38,653 (July 18, 1997).

judgments" that EPA identified were factors such as the nature and severity of health effects, the types of health evidence, the kind and degree of uncertainties involved, and the size and nature of the sensitive populations at risk. Id. at 38,883; EPA Br. at 5.

Finally, in testimony to Congress on the proposed ozone and PM NAAQS, EPA's Administrator stated that "tals you can see from the description of the process I went through to choose proposed levels on ozone and particulate matter, the focus has been entirely on health, risk, exposure and damage to the environment." Testimony of Carol M. Browner, EPA Administrator, Before the Subcomm. on National Economic Growth, Natural Resources, and Regulatory Affairs of the House Comm. on Government Reform and Oversight (Apr.23, 1997) (1997 WL 10571215). In defending her selection of the proposed standards to the public, the Administrator reportedly claimed that "I think it is not a question ofjudgment, I think it is a question of science." Air Quality Standards: Science- Driven Ozone, PMProposals Will Be Finished by July 19, EPA Says, 27 ENV'T REP. (BNA) 2068 (Feb. 14, 1997).


Throughout this proceeding, EPA has identified no policy or normative criteria to justify its NAAQS standards, thus suggesting that science alone can be used to determine the appropriate air quality standard. Science plays a critical, indeed essential, role in evaluating the risks of possible air quality standards being considered for adoption by EPA. However, science by itself cannot provide the justification for selecting a particular air quality standard. Especially in setting standards for non-threshold pollutants, such as in this case, scientific evidence cannot alone indicate where the standard should be set, since any level above zero will cause some health effects. To provide a principled and consistent basis for justifying the setting of such standards at some level above zero, EPA must articulate other factors --whether they be costs or other policy criteria -- to guide its decisions on where to set national ambient air quality standards.


As in the proceedings below, EPA's brief filed in this Court identifies no factors or criteria other than scientific evidence to guide its selection of revised primary national ambient air quality standards for ozone and particulate matter. While science4 is a critical, indeed essential, input in developing standards, science alone cannot provide an "intelligible principle" to guide policy decisions about the level at which to set EPA's revised NAAQS.


Science has played a prominent and important role in agency regulatory decisions, as well as in judicial review of those decisions. Such reliance on science is justified given the advances that science has made over the past few decades in understanding environmental risks. Yet, purporting to rely solely on science to answer questions science is not designed to address is as misguided as it would be to disregard relevant scientific information. Science plays an appropriate and central role in regulatory agencies' assessments of risk, by providing systematic and reliable knowledge about the world. In contrast, risk management decisions, including decisions on setting health standards, are ones for which science alone cannot provide a principled foundation.

4 The term "science" as used throughout this brief refers to the natural sciences.

A. Science Describes and Explains

As this Court recently noted, science is "a process for proposing and refining theoretical explanations about the world." Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 590 (1993) (citing Brief for American Association for the Advancement of Science et al. as Amici Curiae 7-8). As such, science seeks to supply verifiable descriptions of, and explanations about, what is, rather than imposing judgments about what should be. Science describes, it does not prescribe.

B. Risk Management Prescribes

In the context of health and environmental risks, science plays a critical role in identifying, describing, and quantifying risks, but it does not tell us whether such risks are acceptable or should be reduced. The National Academy of Sciences (NAS) recognized this distinction in its influential 1983 report known as the "Red Book," which established a framework for risk analysis on which regulatory agencies continue to rely today. NATIONAL ACADEMY OF SCIENCES/NATIONAL RESEARCH COUNCIL, RISK ASSESSMENT IN THE FEDERAL GOVERNMENT: MANAGING THE PROCESS (1983) ("NAS Red Book").

The NAS distinguished risk assessment from risk management. It defined risk assessment as "the characterization of the potential adverse health effects of human exposures to environmental hazards." Id. at 18. Risk assessment is based on scientific information, supplemented with what have been termed "risk assessment policy" judgments to bridge gaps and uncertainties in the scientific evidence. Id. at 375 Risk assessment is considered to be

5 Such risk assessment policy judgments include factors such as which health effects to consider and to group together, the type of models and assumptions to use in the risk assessment, how to extrapolate data from one small segment of a population to the entire population, and how to compute

predominantly -- though not exclusively6 -- based on scientific evidence and analysis.

Risk management, on the other hand, is "an agency decision-making process that entails consideration of political, social, economic, and engineering information with risk-related information to develop, analyze, and compare regulatory options and to select the appropriate regulatory response to a potential chronic health hazard." NAS Red Book at 18-19. Risk management "necessarily requires the use of value judgments on such issues as the acceptability of risk and the reasonableness of the costs of control." Id. at l9.7 As a subsequent National Research Council report reiterated, "science alone can never be an adequate basis for a risk decision" because "[r]isk decisions are, ultimately, public policy choices."8 This Court has likewise recognized that the

5 (...continued)
and present uncertainties. NAS Red Book at 29-33. These risk assessment policy judgments are comparable to the "public health policy judgments" that EPA identified as a basis for its NAAQS decisions. See 62 Fed. Reg. at 38,883; supra pp. 2-3.

6 E.g.. Sheila Jasanoff, Contested Boundaries in Policy-Relevant Science, 17 Soc. STUD. Sci. 195, 211(1987) (noting that analysts have "agreed that very little in a typical risk assessment could be labeled as pure science"); DANIEL M. Bvitn III & C. RICHARD COTHERN, INTRODUCTION TO RISK ANALYSIS: A SYSTEMATIC APPROACH To SCIENCE-BASED DECISION MAKING 6-8, 330-34 (2000) (risk assessment inherently and inevitably involves some judgment).

7 See also Craig N. Oren, Run Over By American Trucking Part I; Can EPA Revive Its Air Quality Standards?, 29 ENVT'L L. REp. 10,653, 10,660 (Nov. 1999) ("the decision of who should be protected, and what effects they should be protected against, is an ethical decision, not a scientific one").

8 NATIONAL RESEARCH COUNCIL, UNDERSTANDING RISK: INFORMING DECISIONS IN A DEMOCRATIC SOCIETY 26 (1996). This report cautioned against too strict of a separation between risk assessment and risk management, because non-scientific deliberative and policy factors can also be relevant to risk assessment. Id. at 34.

setting of health and environmental standards is primarily a policy rather than scientific undertaking.9

Risk assessment is therefore understood to be predominantly (but not exclusively) a scientific undertaking, whereas risk management decisions, including the selection of standards, require making value judgments that extend beyond the scope of science.10 The National Academy recommended that regulatory agencies should "maintain a clear conceptual distinction between assessment of risks and consideration of risk management alternatives; that is, the scientific findings and policy judgments embodied in risk assessments should be explicitly distinguished from the political, economic, and technical considerations that influence the design and choice of regulatory strategies." NAS Red Book at 7.

EPA has endorsed and relied on the NAS's distinction between risk assessment and risk management.11 For example,

9 In the Court's 1980 review of OSHA's benzene occupational exposure standard, Justice Marshall's dissenting opinion stated: "[W]hen the question involves determination of an acceptable level of risk, the ultimate decision must necessarily be based on considerations ofpolicy as well as empirically verifiable facts. Factual determinations can at most define the risk in some statistical way; the judgment whether that risk is tolerable cannot be based solely on a resolution of the facts." Industrial Union Dep't, AFL-CIO v. American Petroleum Inst., 448 U.S. 607,706(1980). The plurality opinion quoted Justice Marshall's statement, and then responded: "We agree. Thus, while the Agency must support its finding that a certain level of risk exists by substantial evidence, we recognize that its determination that a particular level of risk is 'significant' will be based largely on policy considerations." Id. at 655 n.62 (plurality opinion).

10 See also WILLIAM W. LOwRANCE, OF ACCEPTABLE RISK 75-76 (1976) ("Determining safety, then, involves two extremely different kinds of activities... Measuring risk - measuring the probability and severity of harm--is an empirical, scientific activity; Judging safety judging the acceptability of risks, is a normative, political activity.").

11 E.g., EPA, Science Policy Council, Guidance for Risk Characterization 2 (Feb. 1995) (available at http://www.ena.eov/ORD/spc/rcguide.htm) ("In

in a recent EPA guidance on conducting risk analysis, EPA directed that agency staff should clearly separate risk assessment from risk management, with risk assessment involving the selection, evaluation and presentation of "scientific information," but not "decisions on the acceptability of any risk level for protecting public health or selecting procedures for reducing risks." EPA, Risk Characterization Guidance, supra note 11, at 3.

In contrast, EPA noted that risk management decisions should be based on, to the extent permissible, a consideration of"technological feasibility (e.g., treatability, detection limits), economic, social, political, and legal factors," in addition to the output of the risk assessment process. ld. According to EPA, "risk assessors and risk managers should understand that the regulatory decision is usually not determined solely by the outcome of the risk assessment." Id. In order to make risk assessments "transparent," EPA has further stated that it is important "that conclusions drawn from the science are identified separately from policy judgments and risk management decisions." 63 Fed. Reg. 43,756, 43,769 (Aug. 14, 1998).

3. Agencies Can Use Science as a "Charade"

Notwithstanding broad acceptance that science alone cannot justify judgments about acceptable levels of risk, regulatory agencies such as EPA may find it expedient to cloak policy judgments under the guise of science. Professor Wendy

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1984, EPA endorsed these [NAS] distinctions between risk assessment and risk management for Agency use, and later relied on them in developing risk assessment guidelines.") (endnotes omitted) [hereinafter EPA Risk Characterization Guidance]; EPA, 61 Fed. Reg. 17,960, 17,960 (Apr. 23, 1996) (citing NAS report in adopting risk assessment guidelines "to ensure that the risk assessment process was maintained as a scientific effort separate from risk management.").

Wagner has dubbed this practice a "science charade," which occurs when "agencies exaggerate the contributions made by science in setting [environmental] standards in order to avoid accountability for the underlying policy decision."12

Professor Wagner identified several political, legal and institutional incentives for agencies to engage in the science charade by exaggerating the role and capability of science in making environmental decisions. Id. at 1650-73. For example, the strong deference that reviewing courts give EPA's scientific determinations creates "strong and virtually inescapable incentives to conceal policy choices under the cover of scientific judgments and citations." Id. at 1663. Professor Wagner identified previous NAAQS rulemakings as examples of a science charade. Id. at 1640-44.


Science is central to evaluating the health risks of possible alternative air quality standards, but the decision of which standard to adopt is a risk management determination. As such, standard-setting should utilize all the available scientific evidence on health effects, but also needs to incorporate policy considerations. Scientific data on ozone and particulate matter do not and cannot, without more, provide a principled justification for the level at which the respective NAAQS are set.13

12 Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COL.L.REV. 1613, 1617 (1995).

13 See Congressional Testimony of John D. Graham, Director of Harvard Center for Risk Analysis, on Clean Air Act Reauthorization (Oct. 14, 1999) (1999 WL 27595650) ("scientific information (alone) does not typically provide an intelligible basis for the setting of safe (yet non-zero) amounts of air pollution.").

A. Science Alone Cannot Guide Standard-Setting for Non-Threshold Air Pollutants

The scientific data for ozone and PM indicate a continuum of health effects down to background (or natural) concentrations of the pollutant in the air, at which point the health effects associated with the pollutants cannot be distinguished from effects caused by other factors. There appears to be no clear demarcation of a discrete threshold below which a standard could be set to avoid all health effects.14 EPA acknowledges that there is probably no threshold level for ozone below which no health effects would be expected to occur:

The Administrator's decision to propose the level of an 8-hour primary O3 standard at 0.08 ppm necessarily reflected a recognition ... that it is likely that O3 may elicit a continuum of biological responses down to background concentrations.... Thus, in the absence of any discernable threshold, it is not possible to select a level below which absolutely no effects are likely to occur. Nor does it seem possible, in the Administrator's judgment, to identify a level at which it can be concluded with confidence that no "adverse" effects are likely to occur.
62 Fed: Reg. at 38,863 (citation omitted). EPA further acknowledged that "no standard within the range of levels and forms considered in this review, including the selected standard

14 Science can provide a distinct starting point for standard-setting for a pollutant for which the scientific evidence indicates a threshold in the exposure-response relationship, although the decision to set the standard at or below the threshold is itself a policy rather than scientific determination. In such cases, the Administrator can focus on how far below the threshold to set the standard to achieve an "adequate margin of safety," which also is a policy decision.

is risk-free, due to the continuum of risk likely posed by exposures to ambient O3 potentially down to background levels." Id. at 38,873.15 Given a continuum of health effects, science provides information on the frequency and severity of adverse effects at various levels, but this information by itself does not identify the level at which to set the standard. For non- threshold pollutants, the only standard that could conceivably protect against all health effects would be a standard set at the level of zero, an option that EPA has explicitly ruled out. E.g., 62 Fed. Reg. at 38,863 ("a zero-risk standard is neither possible nor required by the Act").

EPA's own Clean Air Scientific Advisory Committee concluded with respect to ozone that "there is no bright line which distinguishes any of the proposed standards (either the level or the number of allowable exceedences) as being significantly more protective of health" and "[c]onsequently, the selection of a specific level and number of allowable exceedences is apolicyjudgment."'6 In testimony to Congress, the Chair of CASAC reiterated that "the decisions to select a given level or number of allowable exceedences within their proposed ranges cannot be based on science;" rather, the

15 See also id. at 38,867 ("Clearly, for pollutants, such as 03, that have no discernable thresholds for health effects, no standard can be risk-free."). With respect to particulate matter, EPA similarly noted that "the single most important factor influencing the uncertainty associated with the risk estimates is whether or not a threshold concentration exists below which PM-associated health risks are not likely to occur." 62 Fed. Reg. at 38,656. The Agency also recognized that the alternative PM standards it considered "will not he risk-free." Id.

16 Closure Letter from George T. Wolff, Chair, Clean Air Scientific Advisory Committee, to Administrator Carol M. Browner (Nov.30, 1995), at 3 (EPA-SAB-CASAC-LTR-96002) (emphasis added).

selection of a particular standard is "strictly a policy judgment."17

B. EPA's Exclusive Reliance on Science to Justify its Standards Creates the Appearance of a "Charade"

In its brief filed in this Court, as well as in the proceedings below, EPA has defended its selection of its revised ozone and PM NAAQS based solely on scientific grounds. See pp. 2-3, supra. In addition, EPA suggests that this Court should be highly deferential to its selection of NAAQS standards precisely because it is a "scientific determination."18 EPA's justification for its NAAQS standards appears to fit the pattern of what has been called a "science charade," in which an agency attempts to use science to justify its standards, even though the level and form of the standards is not something that science alone can determine.

Scholars have suggested that EPA has not been forthright in justifying its selection of current and past NAAQS standards based solely on science, when the selection of such a standard necessarily depends on risk management value judgments.19

17 Written Statement of George T. Wolff, Chair, EPA's Clean Air Scientific Advisory Committee's Panels on Ozone and PM, for the House Comm. on Health and Env't, Subcomm. on Oversight and Investigations (Apr. 10, 1997) (1997 WL 10569483).

18 EPA Br. at 27 ("When examining this kind of scientific determination, as opposed to simple findings of fact, a reviewing court must generally be at its most deferential.") (quoting Baltimore Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103 (1983)).

19 Wagner, supra note 12, at 1640-44 (EPA's reliance on scientific and medical evidence alone to justify its previous ozone NAAQS is a "vivid illustration" of an "intentional science charade"); R. SHEP MELNICK, REGULATION AND THE COURTS: THE CASE OF THE CLEAN AIR ACT 261 (1983) ("There is, in short, no simple answer to the question of how the EPA sets air quality standards. Medical evidence cannot offer definitive guidance.... The EPA itself has refused to deal with the problem in a

Professor David Faigman, for example, has recently argued that the "real loser in the PM/ozone drama was candor":

The debate was phrased almost entirely in terms of science when the science played a decidedly minor role in the actual decision.... Science should not be used to hide what are essentially the true bases for decision.20
Amici do not purport to know the "true bases" of EPA's selection of its NAAQS, only that science alone cannot provide a consistent and principled basis for its standard- setting.

EPA claims to exclude, for example, considerations of costs and feasibility in setting air quality standards. However, as Professor Joseph Feller, a former EPA attorney, has written, "[i]f all costs are truly ignored, then no risk would be acceptable."21 Scholars and commentators from a diverse range of viewpoints have argued that EPA- does consider costs in setting its air quality standards, even though it excludes consideration of costs in its public justification for its standards.22 Dr. John Graham, Director of the Harvard Center

19 (...continued)
forthright manner, hiding its policy choices behind its interpretation of scientific evidence."); Graham, supra note 13 ("When multi-billion dollar rulemaking decisions are made, it is inevitable that regulators will consider the consequences of their actions as well as the reasonableness of the relationship between risks, benefits and costs.").


21 Joseph M. Feller, Non-Threshold Pollutants and Air Quality Standards, 24 ENVTL. LAW 821, 833 (1994).

22 E.g., FAIGMAN, supra note 13, at 183 ("In practice, therefore, despite the legal technicality limiting EPA to promulgating regulations solely to promote health, costs are an integral part of the policy-making process at EPA."); MELNICK, supra note 12, at 297 ("[R]egulators inevitably consider cost [in setting air quality standards]. But presently they cannot explain

for Risk Analysis, has further argued that EPA's "legal fiction" that it does not consider costs when setting NAAQS is "dysfunctional" because "it (1) reduces political accountability for valuejudgments and political choices, [and] (2) hides from public scrutiny claims that are made about risks, benefits and costs (since such claims are driven 'underground' in the course of regulatory deliberations)." Graham, supra note 13.

EPA's exclusive reliance on science to justify its standard selection thus creates the appearance that the Agency is using science to shield its decision-making from scrutiny. See Wagner, supra note 12, at 1656 (agencies may be able to find refuge from controversial public debates by relying on the

22 (...continued)
how they do."); MARC K. LANDY, MARC J. ROBERTS & STEPHEN R. THOMAS, THE ENVIRONMENTAL PROTECTION AGENCY: ASKING THE WRONG QUESTIONS 238 (1990) ("[I]n the absence of any threshold for risk, some balancing between costs and benefits had to be implicit in the standard setting decision a reality EPA neither acknowledged nor forced the Congress to confront."); George Eads, The Confusion of Goals and Instruments: The Explicit Consideration of Cost in Setting NationalAmbient Air Quality Standards, in MARY GinsoN (ed.), To BREATHE FREELY: RISK, CONSENT, AND AIR 222, 229 (1985) (it is a "policy fiction" that costs are not considered in setting NAAQS); Oren, supra note 7, at 10,662 ("EPA inevitably must therefore consider costs in standard-setting to help decide how stringent to make the standards."); THOMAS 0. MCGARITY, REINVENTING RATIONALITY 253 (1991) ("The institution has considered costs and benefits, and the advice that the Administrator receives orally from subordinates reflects those considerations."); Gary B. Marchant, Turning Two Blind Eyes: The EPA 's Failure to Consider Costs and Health Benefits in Revising the Ozone Standard, 11 Tul. Envtl. L.J. 261, 267-68 (1998) (EPA failed "to 'come clean' about the true nature of its decision-making"); C. Boyden Gray, The Clean Air Act Under Regulatory Reform, 11 TUL. ENVTL. L. J. 235, 235 (1998) ("The plain fact is that the EPA has for a long time considered costs and benefits in setting ambient standardsonly it has done so behind closed doors ); Cass R. Sunstein, Is the Clean Air Act Unconstitutional?, 98 MICH. L. REX'. 303, 317-3 18 (1999) ("Only insiders know for certain whether EPA does in fact consider costs in issuing national ambient air quality standards," but evidence suggests that "costs do matter in the context of standard-setting for nonthreshold pollutants.").

science charade); MELNICK, supra note 12, at 297 ("Far from opening agency decisionmaking to public view, the courts have allowed and encouraged the EPA to sustain a myth and to keep secret its bureaucratic motives."). More significantly, such reliance prevents the Agency from including the careful and open consideration of relevant policy considerations in its justification for its air quality standards.


The EPA has available to it several alternative approaches by which it could incorporate policy considerations into the reasons it provides for setting and revising NAAQS. Such alternative approaches have been relied upon by the EPA and other agencies in other contexts and have been endorsed in the risk management literature. By adopting one or more of these approaches and openly addressing the policy choices reflected in each, EPA can provide a more principled and consistent explanation for its air quality standards.

The Agency could begin by establishing an acceptable risk level as its core policy criterion. For example, EPA has defined "acceptable risk" for hazardous air pollutants based on a maximum individual mortality risk of no greater than 1 in 10 thousand. 54 Fed. Reg. 38,044 (Sept. 14, 1989). The agency has similarly set acceptable risk levels to guide its decision making under other statutes.23 To be sure, extending this "acceptable risk" approach to NAAQS will be complicated by the diverse range of types and severity of health effects

23 The Agency has defined acceptable risk targets under the Clean Water Act, the Comprehensive Environmental Response, Compensation and Liability Act ("Superfund"), the Resource Conservation and Recovery Act, the Federal Insecticide, Fungicide & Rodenticide Act, and the Safe Drinking Water Act. See generally March Sadowitz & John D. Graham, A Survey of Residual Cancer Risks Permitted by Health, Safety and Environmental Policy, 6 RISK 17 (1995).

attributed to ozone or PM exposure. Moreover, using such an approach would mean that the acceptable risk level would become the standard no matter what the costs of achieving it. Nevertheless, if the Agency chose to pursue such an approach in order to establish an intelligible principle for setting air quality standards, it could then apply its acceptable risk criterion to select the least burdensome standard that results in an acceptable level of risk.24

Alternatively, the Agency could find a principle for standard-setting in the comparison of the adverse health and enviroumental effects of pollutants to any countervailing, beneficial effects of those pollutants (such as screening out harmful ultraviolet radiation).25 The Agency would thereby select a level that minimizes overall risk. In such instances of risk-risk tradeoffs, the Agency would combine scientific information about risk with policy judgment about how best to resolve the tradeoff. See generally JOHN D. GRAHAM & JONATHAN B. WIENER, RISK VS. RISK: TRADEOFFS IN PROTECTING HEALTH AND THE ENVIRONMENT (1995).

Another option is for the Agency to consider the full range of costs, beyond countervailing health risks, that can be anticipated to arise from a proposed standard. The Agency could use these broader estimates of costs to balance against estimated benefits in determining the level at which to set a standard. As already noted, it may be that EPA already tacitly

24 Comparative risk analysis may also be helpful in deciding acceptable risk levels, in which the Agency would compare ozone or PM risks to similar risks from other causes. See generally J. CLARENCE DAVIES, COMPARING ENVIRONMENTAL RISKS (1996).

25 The Court of Appeals found that EPA had failed to consider such risk- risk tradeoffs in setting its ozone standards. American Trucking Associations, Inc. v. U.S. Enviromnental Protection Agency, 175 F. 3d 1027, 1052 (D.C. Cir. 1999). Because it did not seek review of that holding by this Court, EPA is required to consider such risk-risk tradeoffs on remand.

takes costs or feasibility considerations into account. By openly incorporating the use of economic analysis into its decision making, the EPA could provide a consistent basis for setting particular air quality standards. As a group of distinguished economists has collectively noted, "[t]he estimation of benefits and costs of a proposed regulation can provide illuminating evidence for a decision, even if precision cannot be achieved."26 In the case of non- threshold pollutants, consideration of costs would not only be illuminating but also is probably inevitable.27 Open deliberation of both benefits and costs by the Agency would provide a principled basis for setting air quality standards.28

Finally, as with costs, the Agency could incorporate into its decision-making explicit and detailed considerations of issues of equity. It would be relevant to risk management decisions for the Agency to consider how the effects of alternative standards may be distributed within society, such as whether health risks are differentially distributed across different racial and socio-economic groups.29

26 Kenneth J. Arrow, Maureen L. Cropper, George C. Eads, Robert W. Hahn, Lester B. Lave, Roger G. Noll, Paul R. Portney, Milton Russell, Richard Schmatensee, V. Kerry Smith, and Robert N. Stavins, Is There a Role for Benefit-Cost Analysis in Environmental, Health, and Safety Regulation?, 272 SCIENCE 221(1996).

27 Sunstein, supra note 22, at 378 ("The problem is that it is impossible to assess 'safety' in a cost vacuum. In general cost-benefit analysis should be followed, acknowledging that it will raise some hard questions of value.")

28 See Edward W. Warren & Gary F. Marchant, "More Good Than Harm A First Principle for Environmental Agencies and Reviewing Courts, 20 ECOL. L. Q. 379 (1993).

29 NATIONAL RESEARCH COUNCIL, UNDERSTANDING RISK, supra note 6, at 40 (noting that "[f]or some interested and affected parties in risk decisions, managing environmental risks has become a question of fairness, moral responsibility, and distributional equity.")

EPA's current approach, purporting to rely exclusively on scientific evidence of adverse health effects, has precluded it from openly adopting alternative approaches that would provide a more reasoned basis for guiding its policy judgment. As with any risk management decision, to justify air quality standards in a principled manner the EPA should expressly consider policy criteria such as acceptable risk, costs, risk-risk tradeoffs, or equity in addition to all the available science.


The lower court's conclusion that EPA "offers no intelligible principle by which to identify a stopping point" (175 F.3d at 1037) is well supported by an understanding of the appropriate role that science is able to play in risk management decision making. While science can identify the level and severity of the health effects from different levels of exposure to ozone or PM in various populations, science alone cannot establish what is acceptable for society.

Respectfully submitted,

 Center for the Study of Law,
 Science and Technology
 Arizona State University 
   College of Law
 P.O. Box 877906
 Tempe, AZ 85257-7906
 (480) 965-3246
 Counsel of Record
 Harvard University
 John F. Kennedy School of 
 79 John F. Kennedy Street
 Cambridge, MA 02138
 (617) 495-1402



GARY E. MARCHANT is Associate Professor of Law at Arizona State University School of Law, and a Faculty Fellow at the Center for the Study of Law, Science and Technology at the same institution. His academic degrees include a J.D. from Harvard in 1990, an M.P.P from the Kennedy School of Government in 1990, and a Ph.D. in Genetics from the University of British Columbia in 1986. His research and teaching interests include Environmental Law, Risk Assessment and Management, Genetics and the Law, and Law, Science, and Technology.

GARY COGLIANESE is Associate Professor of Public Policy at Harvard University's John F. Kennedy School of Government. He received his J.D., M.P.P. (public policy), and Ph.D. in political science from the University of Michigan. His interdisciplinary research in administrative and environmental law explores the impact of procedural design and judicial review on the regulatory process. He teaches in the areas of law, regulatory policy, and ethics.

DANIEL M. BYRD III received both B .A. (1964) and Ph.D. (1971) degrees from Yale University. Since 1988, Dr. Byrd has directed Consultants in Toxicology, Risk Assessment and Product Safety (CTRAPS), a scientific support firm that helps clients acquire, interpret, and use biomedical information. Previously, he conducted independent research into mechanisms ofchemotherapeutic drugs at Roswell Park Memorial Institute and at the University of Oklahoma. He subsequently held positions in the Office of Chemical Control, the Office ofPesticide Programs, the Carcinogen Assessment Group, and the Science Advisory Board (SAB) at the U.S. Environmental Protection Agency (EPA).

GAIL CHARNLEY is an internationally recognized expert in environmental health risk assessment and risk management science and policy. Dr. Chamley has over 20 years of experience in environmental toxicology, human health risk assessment, and risk management. During its tenure, she was executive director of the Presidential/Congressional Commission on Risk Assessment and Risk Management, mandated by Congress to evaluate the role that risk assessment and risk management play in federal regulatory programs. She is immediate past-president of the international Society for Risk Analysis and holds an adjunct faculty position at the Harvard Center for Risk Analysis.

MAUREEN L. CROPPER is a Professor of Economics at the University of Maryland, a Lead Economist at the World Bank and a University Fellow at Resources for the Future. She is past president of the Association of Environmental and Resource Economists and chairs the Advisory Council on Clean Air Compliance Analysis, a subcommittee of EPA's Science Advisory Board. Most of Dr. Cropper's research has dealt with valuing environmental amenities, especially environmental health effects, both from an empirical and a theoretical perspective. Her current research deals with valuing the health impacts of pollution in developing countries and with the economics of deforestation.

E. DONALD ELLIOTT is Professor (Adjunct) of Law at Yale Law School and Georgetown University Law Center, and a Partner in the Washington, D.C. office of Paul, Hastings, Janofsky & Walker. He is a former Assistant Administrator and General Counsel of the U.S. Environmental Protection Agency from 1989-1991, and was previously the Julien and Virginia Cornell Professor of Environmental Law and Litigation at Yale Law School. His research interests are in Law and Science, Environmental Law, and Administrative Law. He is Advisor on Law and Science to the Carnegie Commission on Science, Technology and Government, the Federal Courts Study Committee and the Federal Judicial Center.

DAVID L. FAIGMAN is a Professor of Law at the University of California, Hastings College of Law. He writes extensively on subjects related to the law's use of science. He is a coauthor/coeditor of the three volume work Modern Scient~fic Evidence: The Law and Science of Expert Testimony (West Group, 1997, 2000 Supp.) (with David H. Kaye, Michael J. Saks and Joseph Sanders). He is also the author of the recently published book, LegalAlchemy: The Use and Misuse of Science in the Law (W.H. Freeman & Co. 1999).

JAMES K. HAMMITT is Associate Professor of Economics and Decision Sciences at Harvard University. His research concerns the development and application of quantitative methods -- including benefit-cost, decision, and risk analysis, game theory, and mathematical modeling -- to health and environmental policy. His current research topics include the management of long-term environmental issues with important scientific uncertainties, such as global climate change and stratospheric- ozone depletion, the evaluation of ancillary benefits and countervailing risks associated with risk-control measures, and the characterization of social preferences over health and environmental risks using revealed-preference and contingent- valuation methods. He received his Ph.D. in 1988 from Harvard University.

JAMES E. KRIER is Earl Warren DeLano Professor of Law at the University of Michigan Law School. He has taught and written in the field of environmental law for thirty years. He is the author of Environmental Law and Policy (1971), with a second edition published in 1978 (with Richard Stewart). He is also the co- author (with Ursin) of Pollution and Policy (University of California Press 1977).

WILLIAM HENRY LASH, III is Professor of Law at George Mason University School of Law, and Distinguished Senior Fellow at the Center for the Study of American Business, Washington University. He is also an Adjunct Fellow at Citizens for a Sound Economy and Visiting Professor of Law, Boston College School of Law. He has testified before Congressional committees, spoken before industry and business associations, and written on the limits of EPA regulatory authority and the law and economics of climate change.

ROGER O. McCLELLAN is President Emeritus of the Chemical Industry Institute of Toxicology, having served as President of the Institute from 1988 through 1999, and is an Adjunct Professor at Duke University, University of North Carolina at Chapel Hill, North Carolina State University, University of New Mexico, and Washington State University. Dr. McClellan has served as past Chairman of EPA's Clean Air Scientific Advisory Committee, is a member of the Executive Committee of EPA's Science Advisory Board, has served on several past and current committees of the National Academy of Sciences/National Research Council, and has served in an advisory role to numerous other governmental and private organizations on toxicology issues. He has received numerous honors, including election to membership in the Institute of Medicine of the National Academy of Sciences.

THOMAS W. MERRILL is Professor of Law, Northwestern University School of Law. He was formerly a Deputy Solicitor General (1987-1990) of the United States. His academic interests are centered on Administrative Law but also include Environmental Law and Constitutional Law.

LARS NOAH is a Professor of Law at the University of Florida. His scholarly work has focused on questions of law and medicine, administrative procedure, and products liability, and he has done work for the National Institutes of Health and National Academy of Sciences (Institute of Medicine).

JOYCE E. PENNER is a Professor in the Department of Atmospheric, Oceanic, and Space Sciences at the University of Michigan, Ann Arbor, and is Director of the Laboratory for Atmospheric Science and Environmental Research. She has ongoing research relating to improving climate models through the addition of interactive chemistry and the description of aerosols and their direct and indirect effects on the radiation balance in climate models. These models run in both a parallel computing environment and vector supercomputers. She has an ongoing interest in urban, regional and global tropospheric chemistry and budgets, cloud and aerosol interactions and cloud microphysics, climate and climate change, model development and interpretation.

ROBERT PHALEN is a Professor of Community and Environmental Medicine at the College of Medicine of the University of California, Irvine, CA. He is also the Director of the Air Pollution Health Effects Laboratory at the University of California, Irvine.

JEFFREY J. RACHLINSKI is Professor of Law at Cornell Law School. His academic degrees include a B.A./M.A. in Psychology from the Johns Hopkins University (1988), a J.D. from Stanford Law School (1993), and a Ph.D. in Psychology from Stanford University (1994). Dr. Rachlinski was a National Science Foundation Graduate Fellow in psychology at Stanford University from 1989 to 1993, and a visiting associate professor at the University of Chicago Law School in the spring of 1999. His research interests primarily involve the application of cognitive and social psychology to law, but also include some aspects of Environmental Law.

JOSEPH SANDERS is A.A. White Professor of Law at the University of Houston. He earned both a J.D. and a Ph.D. in sociology from Northwestern University. His research and writing interests include mass torts and scientific evidence. He is the author of Bendectin on Trial (1998) and is a co-editor of Modern Scient~fic Evidence (1997).

ROBERT N. STAVINS is the Albert Pratt Professor of Business and Government, and Faculty Chair of the Environment and Natural Resources Program at the John F. Kennedy School of Government, Harvard University. He is a University Fellow of Resources for the Future, the Chairman of the Environmental Economics Advisory Committee of the U.S. Environmental Protection Agency's Science Advisory Board, and a Member of EPA's Clean Air Act Advisory Committee, the Intergovernmental Panel on Climate Change, and the editorial boards of several scholarly journals. He directed Project 88, a bi-partisan effort co-chaired by former Senator Timothy Wirth and the late Senator John Heinz, to develop innovative approaches to environmental and resource problems. Prior to coming to Harvard, he was a staff economist at the Environmental Defense Fund.

JONATHAN B. WIENER is Professor at the Law School and at the Nicholas School of the Environment, Duke University, where he writes and teaches on issues of environmental law and risk regulation. In 1999 he was a visiting professor at Harvard Law School. His writing includes Risk vs. Risk (1995) (with John Graham) and "Managing the latrogenic Risks ofRisk Management," 9 Risk 39-82 (1998). He has served as President of the Society for Risk Analysis, Research Triangle Chapter, and as a senior aide in the President's Council of Economic Advisers (CEA), the Office of Science & Technology Policy (OSTP), and the Department of Justice, in both the Clinton and Bush administrations. He clerked for Judge Jack B. Weinstein, U.S. District Court, EDNY, and for Judge Stephen G. Breyer, U.S. Court of Appeals for the First Circuit, after graduating from college and law school at Harvard.

JAMES D. WILSON is Senior Fellow and leader of the risk analysis program in the Center for Risk Management at Resources for the Future. An organic chemist by training, he spent twenty-nine years with the Monsanto Company, in research, research management and then health and environmental policy. His research has focused on structure-activity relationships, including environmental chemistry broadly, "dioxin" and related chemicals, relation of chemical structure to physical and physiological propcrties, the use of science in dccision making, and tl~c influcncc oforganizational structure on decision making. His current research at RFF concerns the development and use of standardized risk assessment practices, particularly default options, lie was President of the Society for Risk Analysis in 1993 and was named a Fellow of the Society in that year. He holds an A.B. from Harvard and a Ph.D. (organic chemistry) from the University of Washington.

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