Shifting sands: the limits of science in setting risk standards.

• Author: Coglianese, Cary

INTRODUCTION I. SCIENCE AND SETTING RISK STANDARDS A. "Listen to the Science:" EPA 's Use of Science as a Policy Rationale B. Standard Setting, Science, and the Management of Risk C. The Clean Air Act and the Problem of Non-Threshold Pollutants II. THE ABANDONMENT OF REASON IN EPA's AIR QUALITY STANDARD SETTING A. Science and EPA's Ad Hoc Policymaking B. EPA's Incoherent Disregard of the Health Effects from Particulate Matter C. EPA's Incoherent Disregard of the Health Effects from Ozone D. Comparing the Health Benefits of the Ozone and Particulate Matter Standards III. TOWARD MORE PRINCIPLED RISK MANAGEMENT A. Risk Management Principles 1. Eliminate All Risks 2. Avoid Unacceptable Risks 3. Avoid Unacceptable Costs 4. Balance Costs and Benefits B. Abandoning the Fiction of Ignoring Costs C. Reforming EPA's Air Quality Risk Management CONCLUSION 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, (3) and in exercising their review of agency action under the arbitrary and capricious standard, (4) courts have repeatedly demanded that agencies justify their decisions with careful reasoning. (5) In striving to meet administrative law's demands and aspirations, agencies have applied their expertise to gather facts and to invest in sustained scientific research For regulatory decision makers, science provides a systematic basis for understanding policy problems and the potential consequences of different policy options, and therefore, scientific evidence must play a key role in agency decision making. (6) But even though science is valuable for what it can tell administrators about policy problems and their possible solutions, science alone cannot provide a complete rationale for a policy decision because it does not address the normative aspects of administrative policymaking. (7) 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 inherent in their decision making

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 (8) and particulate matter (PM). (9) Environmental risk management is an area of public policy where science plays a vital role in revealing the health effects associated with human exposure to different substances. (10) It is also an area, however, where agencies have often exaggerated the role of science and thus have escaped their responsibility to give careful reasons for the value judgments implicit in their decision making. (11)

EPA's recent revisions to its air quality standards hold profound implications for both public health and the economy. (12) Not surprisingly, these revisions generated substantial political controversy (13) and led to several rounds of litigation. (14) In the first case to come before the D.C. Circuit, the majority rejected EPA's revised standards, holding that the Agency's application of the Clean Air Act violated the constitutional nondelegation doctrine. (15) Congress delegated authority to EPA to set air quality standards that "'protect the public health' with an 'adequate margin of safety,'" (16) language that the majority held could pass constitutional muster only if EPA applied an "intelligible principle" to cabin its discretion in setting air quality standards. (17) The D.C. Circuit's novel constitutional ruling generated considerable attention and seemed potentially to cast other regulatory statutes into some doubt. (18) On appeal, in the much-heralded case of Whitman v. American Trucking Ass'ns, (19) the Supreme Court rejected the D.C. Circuit's constitutional analysis, holding that the Clean Air Act did not violate the nondelegation doctrine. (20)

The Supreme Court's decision to uphold the Act--and by implication EPA's revised standards--against constitutional challenge resolved what had become one of the most significant and controversial issues in environmental, health, and safety regulation to emerge in recent years. Nevertheless, although the constitutional issues raised by the case have been settled, the revised ozone and particulate standards remain one of EPA's most significant environmental policy decisions. Not only will the standards have important impacts on public health, but these two standards alone are expected to impose more costs on the economy than all other air pollution regulations corn breed. (21) The policy significance of these standards makes all the more salient another vital issue raised by this case, one that was not explicitly addressed by the Supreme Court and that has also escaped much scrutiny in the academic commentary on the case. (22) The unaddressed issue is the question of the appropriate role of science in setting risk standards.

Agencies like EPA must rely on science to make well-informed and effective policy decisions, such as where air quality standards should be set, but they cannot rely on science exclusively to justify these decisions. (23) This Article explains how EPA's invocation of science in defense of its new air quality standards contributed to, or at least deflected attention from, a remarkable series of inconsistencies in EPA's positions Given the way EPA and the courts have interpreted the Clean Air Act, the Agency has been able to, if not been forced to, cloak its policy judgments under the guise of scientific objectivity, with the consequence that the Agency has evaded accountability for a shifting set of policy positions having major implications for public health and the economy. (24) In short, EPA's use of a science-based rhetoric enabled it to avoid responsibility for providing any clear, consistent reasons for its policy choices in setting air quality standards. (25) The Agency's shifting and incoherent approach to its NAAQS decisions ultimately failed to live up to the aspiration for reasoned decision making that undergirds contemporary administrative law. (26)

In Part I of this Article, we show how EPA invoked science to justify its NAAQS revisions, and we explain why such an approach misconceived the role of science in regulatory decision making. Drawing on the conventional distinction between risk assessment and risk management, we show how EPA's retreat behind the cloak of science mistook the normative nature of risk management decisions, such as those involved in setting air quality standards. We also show how policy choices enter into standard setting even more starkly for non-threshold pollutants (such as ozone and particulate matter), where it appears there is no level of exposure that is free from all health effects.

In Part II, we demonstrate that EPA's positions on various aspects of its NAAQS decision making have shifted over time, even during the course of its most recent rulemakings on ozone and particulate matter. When agencies like EPA rely on science as a justification for how they set risk standards, they neglect to offer a principled justification for their policy decisions. (27) In fact, EPA has quite explicitly argued that it should be able to approach each NAAQS rulemaking in an ad hoc manner. (28) With such an ad hoc approach to risk management, inconsistencies are to be expected as an inevitable result, as we show in the incoherent positions EPA adopted in its recent revisions to its air quality standards.

Finally, in Part III we review several alternative principles for justifying risk standards, showing what direction EPA and other regulatory agencies need to take in order to develop more principled approaches to risk management. We conclude that in order to bring greater clarity and coherence to air quality standard setting, Congress will need to step in and direct EPA to use clear policy principles in justifying its decisions. This will almost certainly require a repudiation of the fundamental fiction, endorsed by both EPA and the Supreme Court in Whitman, that risk standards can be set without consideration for the costs or feasibility of complying with them. (29) By amending the underlying statute, Congress can enable and encourage the Agency to live up to the aspirations for reason embedded within contemporary administrative law.

1. SCIENCE AND SETTING RISK STANDARDS

   Throughout its recent ozone and particulate matter rulemakings, EPA attempted to justify its selection of its air quality standards based on scientific evidence, namely evidence of the health effects of such pollution. (30) In the early stages of the rulemaking, EPA's emphasis on science was more restrained, and Agency documents sometimes noted obliquely that there was some room for policy inputs in risk management. (31) As the Agency's rulemaking proceedings progressed, however, and as the amount of controversy surrounding them increased, EPA's reliance on science to justify and defend its standards became more pronounced.

   EPA initially emphasized its scientific evidence partly in response to a campaign by opponents who questioned the soundness of the science underlying EPA's standards. (32) EPA understandably responded to these attacks by attempting to defend the validity of its scientific findings. Yet, in addition to defending the Agency's scientific research on its own merits, EPA soon came to inflate the role of science, using science in an attempt to justify its standards in order to provide greater support for its position in the political arena and the courts. (33)

   In this Part, we show how EPA appealed to a science-based rhetoric in its ozone and particulate matter rulemakings, and we explain why such...