No. 99-1257
========================================
IN THE SUPREME COURT OF THE UNITED STATES
--------------------
CAROL M. BROWNER, ADMINISTRATOR OF THE
ENVIRONMENTAL PROTECTION AGENCY, ET AL.,
Petitioners,
v.
AMERICAN TRUCKING ASSOCIATIONS, INC., ET AL.,
Respondents.
--------------------
BRIEF AMICI CURIAE OF GARY E. MARCHANT, CARY COGLIANESE, DANIEL M. BYRD III, GAIL CHARNLEY, MAUREEN L. CROPPER, E. DONALD ELLIOTT, DAVID L. FAIGMAN, JAMES K. HAMMITT, JAMES E. KRIER, WILLIAM H. LASH III, ROGER O. McCLELLAN, THOMAS W. MERRILL, LARS NOAH, JOYCE E. PENNER, ROBERT PHALEN, JEFFREY J. RACHLINSKI, JOSEPH SANDERS, ROBERT N. STAVINS, JONATHAN B. WIENER and JAMES D. WILSON IN SUPPORT OF RESPONDENTS
Filed September 11th, 2000
TABLE OF CONTENTS
INTEREST OF THE AMICI
BACKGROUND
SUMMARY OF ARGUMENT
ARGUMENT
- SCIENCE ALONE CANNOT PROVIDE A BASIS FOR RISK MANAGEMENT DECISIONS
- Science Describes and Explains
- Risk Management Prescribes
- Agencies Can Use Science as a "Charade"
- SCIENCE ALONE CANNOT PROVIDE A BASIS FOR THE OZONE AND PM NAAQS
- Science Alone Cannot Guide Standard-Setting for Non-Threshold Air Pollutants
- EPA's Exclusive Reliance on Science to Justify its Standards Creates the Appearance of a "Charade"
- PRINCIPLED STANDARD-SETTING REQUIRES CONSIDERATION OF MORE TITAN SCIENCE
CONCLUSION
APPENDIX: IDENTIFICATION OF AMICI
INTEREST OF AMICI
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
BACKGROUND
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).
SUMMARY OF ARGUMENT
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.
ARGUMENT
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 science
4 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.
I. SCIENCE ALONE CANNOT PROVIDE A BASIS FOR RISK MANAGEMENT DECISIONS
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
(continued...)
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
(continued...)
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
11 (...continued)
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.
II. SCIENCE ALONE CANNOT PROVIDE A BASIS
FOR THE OZONE AND PM NAAQS
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
(continued...)
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.").
20 DAvID L. FAIGMAN, LEGAL ALCHEMY: TI-IEUSE AND MISUES OF
SCIENCE
IN THE LAW 187 (1999).
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
(continued...)
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 standards—only 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.
III. PRINCIPLED STANDARD-SETTING REQUIRES CONSIDERATION OF MORE THAN SCIENCE
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.
CONCLUSION
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,
GARY E. MARCHANT
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
|
CARY COGLIANESE
Counsel of Record
Harvard University
John F. Kennedy School of
Government
79 John F. Kennedy Street
Cambridge, MA 02138
(617) 495-1402
|
SEPTEMBER 11,2000
APPENDIX
IDENTIFICATION OF AMICI
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.