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Shifting Sands: The Limits of Science in
Setting Risk Standards
Cary Coglianese and Gary E. Marchant
August 2003
RWP03-036
SHIFTING SANDS:
THE LIMITS OF SCIENCE IN SETTING RISK STANDARDS
Cary Coglianese
*
and Gary E. Marchant
**
Introduction…………………………………………………………….. 2
I. Science and Setting Risk Standards..………………………………... 7
A. “Listen to the Science:” EPA’s Use of Science as a
Policy Rationale………………………………………………… 10
B. Standard-Setting, Science, and the Management of Risk..……... 21
C. The Clean Air Act and the Problem of Non-Threshold
Pollutants………………………………………………………... 31
II. The Abandonment of Reason in EPA’s Air Quality Standard
Setting……………………………………………………………… 40
A. Science and EPA’s Ad Hoc Policy Making…………………….. 42
B. EPA’s Incoherent Disregard of the Health Effects from
Particulates ……………………………………………………... 51
C. EPA’s Incoherent Disregard of the Health Effects from Ozone... 59
D. Comparing the Health Benefits of the Ozone and Particulates
Standards………………………………………………………... 73
III. Toward More Principled Risk Management……………………….. 76
A Risk Management Principles……………………………………. 77
B Abandoning the Fiction of Ignoring Costs……………………… 93
C Reforming EPA’s Air Quality Risk Management………………. 101
Conclusion……………………………………………………………… 113
*
Cary Coglianese is Associate Professor of Public Policy and Chair of the
Regulatory Policy Program at the John F. Kennedy School of Government,
Harvard University. He is also an affiliated scholar at the Harvard Law School and
in 2004 will be the Irvine Visiting Professor of Law at Stanford Law School. He
served as counsel of record and co-author with Gary Marchant on an amicus curiae
brief filed with the U.S. Supreme Court in Whitman v. American Trucking
Associations on behalf of twenty scientists and legal scholars.
**
Gary E. Marchant is Professor and Executive Director of the Center for the Study
of Law, Science, and Technology at the Arizona State University College of Law.
When in private practice, he represented the American Trucking Associations in its
initial proceedings in the D.C. Circuit Court of Appeals, but he has had no
association with any of the parties since assuming his current position in advance
of the briefing of Whitman in the Supreme Court.
1
We are grateful for helpful comments on earlier versions of this article from
John Applegate, James Conrad, E. Donald Elliott, James Hamilton, Prasad
Kadambi, Richard Pierce, and Cass Sunstein.
Introduction
Administrative law aspires to bring reason to agency
policymaking.
1
The Administrative Procedure Act
2
requires agencies
to specify the basis for the rules they promulgate, and in exercising
their review of agency action under the arbitrary and capricious
standard,
3
courts have repeatedly demanded that agencies justify their
decisions with careful reasoning.
4
In striving to meet administrative
1
See, e.g., Lisa Schultz Bressman, Disciplining Delegation After Whitman v.
American Trucking Ass’ns, 87 CORN. L. REV. 452, 485 (2002) (Administrative law
principles “require agencies in general to articulate a basis for their policy
determinations and, in particular, to articulate the standards for those
determinations.”); Jerry L. Mashaw, Small Things Like Reasons Are Put in a Jar:
Reason and Legitimacy in the Administrative State, 70 F
ORD. L. REV. 17 (2001)
(arguing that the demand for reason is stronger in administrative law than even in
judicial decisionmaking); CASS R. SUNSTEIN, ONE CASE AT A TIME: JUDICIAL
MINIMALISM ON THE SUPREME COURT 31 (1999) (“Much of administrative law
consists of an effort to ensure reason-giving by regulatory agencies. . .The agency. .
. must generate a convincing explanation.”).
2
5 U.S.C. § 553(c) (1994).
3
5 U.S.C. § 706(2)(a) (1994).
2
4
See, e.g., Motor Vehicle Manufacturers Assn. v. State Farm Mutual Automobile
Insurance Co., 463 U.S. 29 (1983) (referring to the “strict and demanding
requirement” that “an agency must cogently explain why it has exercised its
discretion in a given manner.”). See also AT&T Corp. v. FCC, 236 F.3d729, 736
(D.C. Cir. 2001) (invalidating FCC rule because the agency “has considered this
question on several occasions, each time applying a test different from that applied
here”); Pearson v. Shalala, 164 F.3d 650, 660-61 (D.C. Cir. 1999) (an agency
cannot “refuse to define the criteria it is applying,” and “it must be possible for the
regulated class to perceive the principles which are guiding agency action.”);
American Lung Ass’n v. EPA, 134 F.3d 388, 392-93 (D.C. Cir. 1998) (“[U]nless
[the Administrator] describes the standard under which she has arrived at this
conclusion, ... we have no basis for exercising our responsibility to determine
whether her decision is ‘arbitrary [or] capricious.’”); Hall v. McLaughlin, 864 F.2d
868, 872 (D.C. Cir. 1989) (“Reasoned decisionmaking requires treating like cases
alike; an agency may not casually ignore its own past decisions. . . . Divergence
from agency precedent demands an explanation.”); Small Refiners Lead Phase-
Down Task Force v. EPA, 705 F.2d 506, 525 (D.C. Cir. 1983) (“By EPA’s logic,
adverse health effects would permit it to justify any lead standard at all, without
explaining why it chose the level it did. We cannot accept such incomplete
reasoning.”); Greater Boston Television Corp. v. FCC, 444 F.2d 841, 852 (D.C.
Cir. 1970), cert. denied, 91 S.Ct. 2229 (1971) (“But an agency changing its course
must supply a reasoned analysis indicating that prior policies and standards are
being deliberately changed, not casually ignored, . . . and if an agency glosses over
law’s demands and aspirations, agencies have applied their expertise
to gather facts and invest in sustained scientific research. For
regulatory decisionmakers, science provides a systematic basis for
understanding policy problems and the consequences of different
policy options, and thus scientific evidence needs to play a key role
in agency decisionmaking.
5
But even though science is valuable for
what it can tell administrators about policy problems and their
possible solutions, science does not by itself provide a complete
reason for a policy decision because it does not address the normative
aspects of administrative policymaking.
6
To fulfill administrative
law’s aspiration of reason, agencies need to explain their decisions by
reference not only to scientific evidence but also to policy principles
that speak to the value choices implicit in their decisionmaking.
In this article, we examine the role and limitations of science in
the important policy domain of environmental risk management. In
particular, we offer a detailed account of the use – and misuse – of
science by the Environmental Protection Agency (EPA) in its efforts
to justify recent changes to its national ambient air quality standards
(NAAQS) for ozone and particulate matter (PM).
7
Environmental
risk management is an area of public policy where science plays a
vital role for what it reveals about the health effects associated with
human exposure to different substances.
8
It is also an area, however,
or swerves from prior precedents without discussion it may cross the line from the
tolerably terse to the intolerably mute.”).
5
NATIONAL RESEARCH COUNCIL, STRENGTHENING SCIENCE AT THE U.S.
E
NVIRONMENTAL PROTECTION AGENCY: RESEARCH MANAGEMENT AND PEER
REVIEW PRACTICES 24 (2000) (“In the absence of sound scientific information,
high-risk problems might not be adequately addressed, while high-profile but
lower-risk problems might be targeted wastefully.”); C
HRISTOPHER F. EDLEY, JR.,
A
DMINISTRATIVE LAW: RETHINKING JUDICIAL CONTROL OF BUREAUCRACY 14
(1990) (highlighting science as one of the three central aspects of administrative
decisionmaking); Alon Rosenthal, George M. Gray & John D. Graham, Legislating
Acceptable Cancer Risk from Exposure to Toxic Chemicals, 19 ECOL. L.Q. 269,
270 (1992) (“Scientific information about the human health risks of exposure to
toxic chemicals is critical to making sound regulatory decisions.”).
6
See infra notes 35-37 and accompanying text.
7
EPA, National Ambient Air Quality Standards for Ozone; Final Rule, 62 Fed.
Reg. 38,856 (July 18, 1997) [hereinafter “EPA, Ozone Final Rule”]; EPA, National
Ambient Air Quality Standards for Particulate Matter; Final Rule, 62 Fed. Reg.
38,651 (July 18, 1997) [hereinafter “EPA, PM Final Rule”].
3
8
See infra notes 35, 410 and accompanying text.
where agencies have often exaggerated the role of science and thus
have escaped responsibility for giving careful reasons for the value
judgments implicit in their decisionmaking.
9
EPA’s recent revisions to its air quality standards hold enormous
implications for society in terms of their impact on both public health
and the economy.
10
These revisions generated substantial political
controversy
11
and led to several rounds of litigation.
12
In the initial
round in the United States Court of Appeal for the District of
Columbia Circuit, the majority rejected EPA’s revised standards,
holding that the Agency’s application of the Clean Air Act violated
the constitutional non-delegation doctrine.
13
Congress delegated
authority to the EPA to set air quality standards that “protect the
public health” with “an adequate margin of safety,”
14
language that
the majority held could meet constitutional muster only if EPA
applied an “intelligible principle” to cabin its discretion in setting air
quality standards.
15
The D.C. Circuit’s novel constitutional ruling
generated considerable attention and seemed even possibly to cast
other regulatory statutes into some doubt.
16
On appeal, in the much-
9
Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COL. L.
R
EV. 1613 (1995).
10
See infra notes 366-67 and accompanying text.
11
See infra note 70 and accompanying text.
12
The standards were the subject of multiple decisions in the D.C. Circuit Court
in addition to a major decision in the Supreme Court. For discussion of the
litigation, see infra notes 13-18, 405-09 and accompanying text.
13
American Trucking Ass’ns, Inc. v. EPA, 175 F.3d 1027 (D.C. Cir. 1999).
14
42 U.S.C. § 7409(b)(1).
15
American Trucking, 175 F.3d at 1037.
4
16
The constitutional issues presented in Whitman received extensive academic and
legal analysis. E.g., Craig N. Oren, Run Over By American Trucking Part I; Can
EPA Revive Its Air Quality Standards?, 29
ENVT’L L. REP. 10,653 (Nov. 1999);
Cass R. Sunstein, Is the Clean Air Act Unconstitutional?, 98 M
ICH. L. REV. 303
(1999) [hereinafter “Sunstein, Unconstitutionality”]; Richard J. Pierce, The
Inherent Limits on Judicial Control of Agency Discretion: The D.C. Circuit and the
Nondelegation Doctrine, 52 ADMIN. L. REV. 63 (2000); C. Boyden Gray, The
Search for an Intelligible Principle: Cost-Benefit Analysis and the Nondelegation
Doctrine, 5 TEX. REV. L. & POL. 1 (2000).; Ernest Gellhorn, The Proper Role of
the Nondelegation Doctrine, 31 ENVT’L L. REP. 10232 (2001); Thomas O.
McGarity, The Clean Air Act at a Crossroads: Statutory Interpretation and
Longstanding Administrative Practice in the Shadow of the Delegation Doctrine, 9
N.Y.U. L. Rev. 1 (2000); Cass R. Sunstein, Regulating Risks After ATA, 2001 Sup.