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Thomas O. McGarity, JD

The author is with the University of Texas School of Law, Austin. He is also with the Center for Progressive Regulation, Washington, DC.

Correspondence: Requests for reprint should be sent to Thomas McGarity, JD, University of Texas School of Law, 727 East Dean Keeton St., Austin, TX 78705 (e-mail: tmcgarity{at}mail.law.utexas.edu).

	ABSTRACT

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Assigning a Daubert-like gatekeeper role to courts engaged in judicial review of risk assessments prepared by federal agencies is a profoundly bad idea.

I describe the role of courts in reviewing regulatory agency decisionmaking and explore the potential impact of incorporating Daubert principles into administrative law. A Daubert form of judicial review will prevent agencies from employing a "weight of the evidence" approach, forcing them to adopt a "corpuscular" approach that rewards efforts by regulatees to find and exaggerate flaws in individual scientific studies.

Consequently, applying Daubert to federal agency decisionmaking will have a predictable impact on regulatory policy that runs directly counter to the precautionary policies that animate most health, safety, and environmental statutes.

	INTRODUCTION

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When Congress enacted the landmark health, safety, and environmental laws of the 1970s, it required regulatory agencies such the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) to implement those laws by writing regulations pursuant to the Administrative Procedure Act.¹ Congress understood that executive branch agencies would have the expertise required to bring scientific and other technical considerations to bear on the complex issues raised by governmental attempts to protect human health and the environment. Congress also provided persons adversely affected by those regulations an opportunity to seek judicial review of those rulemaking exercises.²

Scientific expertise plays a critical role in regulatory decisionmaking under health, safety, and environmental laws.³ When EPA or OSHA promulgates an ambient air quality standard or an occupational health standard for an air pollutant, for example, the agency must gather information on the hazard posed by the pollutant to human health, the level of ambient exposure to the pollutant, and the risks to human health posed by that level of ambient exposure. This ordinarily involves an assessment of existing epidemiological, toxicological, and pharmacokinetic studies as well as ambient monitoring and air quality modeling. Some of the relevant scientific studies will be published in the peer-reviewed literature, and some will not have been published. Some will be of very high quality; some will be of relatively low quality or of marginal relevance; and some will be so irrelevant or poorly executed as to warrant very little attention from the agency scientists.

In these scientific rulemaking exercises, agency scientists must exercise scientific discretion in deciding which studies to emphasize, which to consider but not rely upon too heavily, and which to eliminate from consideration altogether. The scientists then prepare an assessment of the relevant studies that reflects their judgment based on the overall weight of the evidence available to them.⁴ The ultimate agency decision-makers must consider the scientific assessment, including the inevitable uncertainties involved in that assessment, and various legal and policy considerations in determining the proper level for the ambient standard. That decision, in turn, is subject to judicial review on the basis of a rulemaking record that will include the scientific assessment, the agency’s explanation, and all of the comments submitted by outsiders during the prescribed comment period.

This article explores the sometimes tense relationship between the exercise of scientific expertise by regulatory agencies and the legal requirement that the outcome of that exercise be reviewed by a court consisting of three nonexpert lawyers.

	SCIENCE IN REGULATORY AGENCIES

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As the process of scientific rulemaking has evolved over the years, agencies have devoted increasing attention to the quality of the scientific information and analysis that they bring to bear on rulemaking initiatives. This topic is, however, inherently difficult to address in a quantitative or otherwise objective way.⁵ Opinions about the quality of the scientific input into agency decisions vary depending on the perspective of the observer and on the level of expectation. Academic scientists accustomed to high levels of quantitative accuracy are frequently disappointed by the lack of quantitative precision in agency risk assessments. Other observers more sensitive to the realities of regulatory decisionmaking under conditions of scientific uncertainty tend to provide more sympathetic evaluations. Not surprisingly, opinions also depend a great deal on the particular regulatory program being evaluated.

In the early 1990s, the administrator of EPA assembled an expert panel of four senior academicians to evaluate the role of science in EPA decisionmaking.⁶ The panel concluded that science at EPA was of "uneven quality," and it reported that the agency’s "policies and regulations" were "frequently perceived as lacking in strong scientific foundation." The panel did not, however, reach a conclusion on whether the perceptions reflected reality. Its findings and regulations instead focused primarily on structural changes, beefing up EPA’s support for its scientific staff, and devoting greater attention to improving outside perceptions of the agency’s scientific activities. The committee urged EPA to "create the climate, culture, and incentives necessary to encourage superior science."

EPA responded by making a commitment in its most recent 10-year plan to "develop and apply the best available science for addressing current and future environmental hazards, as well as new approaches toward improving environmental protection."⁷ The agency also established a National Center for Environmental Research and Quality Assurance to develop and manage quality assurance policy for the scientific input into agency rulemaking initiatives.

A more recent and considerably more comprehensive study of the role of science in EPA decisionmaking concluded that "[o]ver time science at EPA has become more institutionalized, decentralized, consistent, rigorous, and comprehensive." The agency has also "markedly increased its use of external scientific review and become more willing to acknowledge scientific uncertainties." The study cautioned that "while EPA’s use of science has improved gradually, the bar for what passes as adequate regulatory science has been raised substantially." The expectations of outsiders for "sound science" in regulatory decisionmaking "increased faster than the quality and the breadth of the science" available to agencies with limited resources of their own to fund scientific research.

The study noted that one of the more important factors impeding EPA’s use of science in developing regulations was the fact that the rulemaking process was generally driven by the need to produce a product that could survive judicial review and be easily enforceable in court. One internal manifestation of this pressure was a legalistic rulemaking culture that resulted in "the agency’s treatment of scientific evidence as either admissible or inadmissible, rather than [its] taking a scientific approach to see what could be inferred from all of the available evidence."

The primary limitation on the quality of the scientific input into agency rulemaking lies in the poor quality of the data available to the agency. Because regulatory agencies typically lack resources to support much original scientific research related to hazard assessment, they must rely on the published literature, on studies funded by research-oriented agencies like the National Science Foundation, and on data provided regulated industries. For exposure assessments, agencies draw on "a bewildering number of sources of data," very little of which is published in scientific literature because it tends to come from routine and nonexperimental monitoring sources. Hence, the exposure data used in agency rulemaking are typically "sparse and of generally poor quality." Yet attempts to acquire better monitoring data usually encounter opposition from regulated industries.

When agencies lack high-quality scientific data, as is frequently the case with respect to exposure analyses, they fill in the data gaps with modeling exercises based on assumptions. Although the agencies themselves often develop the models, they also draw upon models developed by outside scientists in academia and consulting firms. Disputes over the assumptions that underlie exposure modeling exercises are as often the source of challenges to agency rules as disputes over the quality of the scientific data that the agency uses. In the past, courts have generally deferred to agency modeling exercises when they are persuaded that the dispute is really a battle of experts over the assumptions and algorithms underlying the models.⁸

Agencies frequently rely upon scientific advisory committees composed of highly credentialed academic scientists to provide a critical quality control function. EPA’s prestigious Science Advisory Board, for example, can draw, on an ad hoc basis, on the scientific expertise of hundreds of academic experts from around the country to review and provide constructive comments on EPA decisionmaking documents. In addition, Congress has established separate standing scientific advisory groups, like the Clean Air Scientific Advisory Committee and the FIFRA Scientific Advisory Panel, to provide continuing scientific advice to the agency program offices.⁵ In the last 10 years, the Science Advisory Board has grown in stature and in its importance to EPA rulemaking. By its own estimate, about 50% of EPA’s major activities are "debated, reviewed or influenced" by the Science Advisory Board. Although scientific review committees are sometimes criticized for straying from the realm of science into matters of regulatory policy, few question the effectiveness of the quality control function that they perform.⁵ It is highly unlikely that "junk science" will survive the serious scientific review provided by such entities.

In sum, opinions vary as to the quality of the scientific data and analysis that federal agencies use in promulgating health, safety, and environmental regulations. Undoubtedly, some improvements in the quality of the available data are possible, but major improvements in the scientific information available on the health effects and environmental exposures to pollutants will not be possible without dramatic increases in the resources devoted to health effects research and environmental monitoring. Whatever one’s views on the quality of the scientific information underlying health and environmental rulemaking exercises, it seems clear that the amount and quality of the data available for health and environmental decisionmaking is not something that can adequately be addressed by courts reviewing individual agency rules.

	DAUBERT AND THE CORPUSCULAR APPROACH TO SCIENTIFIC EVIDENCE

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As plaintiff’s lawyers began to build on their successes in the asbestos cases by bringing toxic tort actions against the manufacturers of other disease-causing products, it became increasingly clear to potential defendants and to their trade associations that tort law could bring about profound changes in the way they did business.⁹ Business groups and conservative foundations created think tanks and funded academic research aimed at highlighting so-called "frivolous lawsuits."¹⁰ Manhattan Institute fellow Peter Huber wrote a well-publicized polemic in which he argued, based largely on anecdotal evidence, that plaintiffs’ claims of causal association between exposures to toxic substances and disease were often based on what he pejoratively called "junk science."¹¹ Although the empirical basis for this criticism was never convincingly established,¹² it had a remarkable political salience in subsequent state and federal debates over "tort reform."¹³

The Daubert/Joiner Impact on Tort Law
The Daubert v Merrell Dow Pharmaceuticals, Inc case gave the Supreme Court an opportunity to address the "junk science" issue head-on.¹⁴ Because nearly all causation claims in toxic tort litigation ultimately stand or fall on expert testimony,¹⁵ one way to ensure the validity of such claims, and incidentally to reduce the number of successful lawsuits, is to raise the bar on admissibility of expert testimony. The Daubert litigation thus gave the Supreme Court an opportunity to stem the increasing flow of resource-intensive toxic tort lawsuits through a politically invisible interpretation of the words "scientific and knowledge" in the obscure Federal Rules of Evidence.¹⁶

The Supreme Court in Daubert held that federal district courts must perform a "gatekeeper" role in cases involving expert testimony.¹⁴ Trial judges with no training in science or scientific method must become sufficiently acquainted with the scientific underpinnings of expert testimony offered by parties in common law litigation to determine whether that testimony represents a sufficiently sound application of the relevant scientific principles to a sufficiently robust set of scientific data to justify the expert’s scientific conclusions.¹⁷ At the same time, the trial judge must determine whether the "fit" between the scientific testimony and the issues raised by the parties is sufficiently tight to render that testimony legally relevant.¹⁷ Dicta in the subsequent General Electric Co v Joiner¹⁸ opinion suggested that the trial court had an obligation to evaluate the scientific validity of an expert’s conclusions as well as the basis for those conclusions. The Federal Rules of Evidence, which are applicable in all civil cases tried in federal courts, were then amended to incorporate the Daubert/Joiner tests.¹⁹

It is now clear after a decade’s experience with Daubert that the lower courts have applied it quite vigorously to exclude expert testimony.²⁰ Because the plaintiff ordinarily has the burden of proof in tort litigation, this aggressive invocation of the judge’s new role as guardian of the purity of scientific evidence has had a disproportionate impact on plaintiffs. Federal courts are now excluding testimony of well-regarded experts based upon smoke screens thrown up by artful defense counsels.¹⁵ A plaintiff’s attorney must come to court prepared not only to establish the expert’s qualifications, but also to demonstrate to a skeptical trial judge that the testimony forms scientifically reliable conclusions based on scientifically reliable data and that those conclusions fit the legal requirements for establishing cause-in-fact.²¹

Extending Daubert to Rulemaking
Attorneys for companies that have used Daubert successfully to avoid accountability for harms caused by their products and byproducts are now urging the federal courts to assume a similar gatekeeper role when they review risk assessments prepared by federal regulatory agencies.²² Convinced that legislative and presidential oversight are not sufficient to ensure responsible and accountable decisionmaking in federal regulatory agencies, corporate attorney Alan Charles Raul argues that the judges must assume a more active role.²³ Applying Daubert principles to judicial review of agency risk assessments would, in Raul’s view, "promote the full disclosure of all of the Agency’s underlying principles, assumptions, and facts and obligate the Agency to come completely clean on the foundation for its scientific decision."²²

Skeptics argue that judicial adoption of a regulatory Daubert approach will likely result in unconstrained regulatory policymaking by unaccountable and scientifically illiterate judges and a much higher incidence of judicial remands of important regulations. Regulatees will devote greater resources to sponsoring research aimed at pointing the regulatory finger away from their products. When scientific studies with adverse regulatory implications for regulatees are published, they will hire consultants to fill the scientific literature with critical letters to the editor that regulatees will later cite to support claims that the studies are fatally flawed. Regulatees will reinvigorate attempts to pack advisory committees with sympathetic scientists in the hope of slipping qualifying language into advisory committee reports, and they will send industry scientific consultants to advisory committee meetings to make the case for such qualifying language. At the end of the process, lawyers for the regulatees will then bring all of this regulatee-generated criticism and information to the attention of credulous judges in an attempt to discredit each of the studies upon which the agency relies. The bottom line will be fewer rules to get in the way of regulatees and fewer protections for the beneficiaries of the congressionally mandated programs.²⁴

Proponents of the regulatory Daubert approach respond that it would "not only encourage less deference and more probing judicial review but also establish more consistent standards."²² If the courts adopted that approach, "it wouldn’t always be a roll of the dice as to which judicial panel you get, or what appellate or district court you’re before, as to how intensive the judicial review of agency science will be."²² This is apparently because even those courts that were previously willing to defer to the agency resolution of complex science/policy issues would now require the agency explanations to meet stringent judicial standards of scientific adequacy.

Despite the assurances of its proponents, however, it is by no means certain that good agency decisions would consistently satisfy courts applying regulatory Daubert principles or that "bad" agency decisions would consistently be set aside. The Daubert principles do not constrain judicial discretion within discernible boundaries. Indeed, the essence of the trial judge’s gatekeeper function under Daubert is to exercise judicial discretion over expert testimony that goes before the jury. The court of appeals function under a regulatory Daubert regime is not likely to be less discretionary. Yet, providing wide latitude to reviewing judges is hardly a recipe for arriving at consistency in judicial outcomes. Of greater concern for those interested in the role of science in health, safety, and environmental regulation, the Daubert-izing judicial review of rulemaking would require the courts to employ a Daubert-inspired corpuscular approach to the evaluation of scientific conclusions underlying risk assessments prepared by regulatory agencies that have a great deal more technical expertise than a lay jury.

The Post-Daubert Corpuscular Approach to Conclusions Based on Scientific Studies
In the wake of Daubert and Joiner, most courts have adopted a corpuscular approach to determining the admissibility of expert testimony in toxic tort cases. Under this approach, the party offering scientific expert testimony must establish the relevance and reliability under the Daubert/Joiner criteria of each individual study on which the expert relies as well as the relevance and reliability of the expert’s overall conclusions.¹⁵ If the plaintiff fails to establish the scientific reliability of a sufficient number of individual studies, the trial judge will exclude the expert’s testimony and (in the absence of other relevant and reliable expert testimony on causation) dismiss the case before the jury ever enters the picture. This approach, in practice, places a heavy burden on the plaintiff to validate each of the studies relied upon by the plaintiff’s experts as well as to establish the scientific reliability of their overall conclusions. It invites defendants to focus on flaws in the corpuscles of data underlying the testimony rather than on the scientific reliability of the expert’s overall conclusions.

The corpuscular approach effectively prevents the expert in toxic torts cases from applying the cumulative weight-of-the-evidence approach that regulatory agencies universally employ in assessing the risks that toxic substances pose to human beings.²⁵ The weight-of-the-evidence approach focuses upon the totality of the scientific information and asks in a holistic way whether a cause-and-effect conclusion appears warranted. Given the inevitability of flaws in individual studies and the fact that some of the studies were not undertaken with litigation or the regulatory process in mind, this necessarily involves the exercise of scientific judgment grounded in scientific expertise, and regulatory agencies are supposed to be repositories of scientific expertise. The corpuscular approach to judicial review focuses on the inevitable flaws in individual studies and asks whether a sufficient number of relevant studies with sufficiently few flaws remain to support a conclusion that is itself relevant and reliable. Under the corpuscular approach, a study is either valid or invalid, and it is either relevant or irrelevant to the scientific issue that the agency must resolve. Both determinations are made by judges who lack any scientific expertise.

The courts that apply the corpuscular approach in determining the admissibility of expert testimony have adopted a remarkably different, and arguably much less scientific, approach to causation than the regulatory agencies charged with the responsibility of protecting citizens from toxic risks. Under the regulatory Daubert approach to judicial review of agency risk assessments, the reviewing courts would predictably adopt a similar approach. Ultimately, the agency would have to present its defense of its regulation in the corpuscular format adopted in Joiner. Rather than describing the studies that supported a particular conclusion regarding the risks presented by human exposures to a toxic substance and assessing those risks under a weight-of-the-evidence approach applied to the entirety of the data, the agency would have to establish the scientific validity of each study that it deemed relevant, support its relevance determination with scientifically valid reasoning, and convince skeptical judges that the agency’s overall assessment of the risks was not arbitrary and capricious.

The "Hard Look" Doctrine and the Corpuscular Approach
When federal agencies began seriously exercising their rulemaking powers for the first time in the early 1970s, the District of Columbia Circuit, which heard the bulk of the appeals, crafted the "hard look" metaphor for judicial review of informal rulemaking.²⁶ Under this approach, the courts must take a hard look at the administrative record and the agency’s explanatory material to determine whether the agency used appropriate analytical methodologies, applied the proper criteria, considered the relevant factors, chose from among the available regulatory options, relied upon allowable policies, and pointed to adequate support in the record for material empirical propositions. The "hard look" metaphor rapidly caught on in the courts of appeals and the legal academy, and the Supreme Court arguably adopted a form of hard-look review in Motor Vehicles Manufacturers Association v State Farm Mutual Automobile Insurance Co.²⁷ Under the frequently cited State Farm formula, a regulation is arbitrary and capricious if the following conditions exist:

[T]he agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.

The first two elements—whether the agency relied on the wrong factors or failed to consider an important aspect of the problem—invites the reviewing court to evaluate the manner in which the agency goes about implementing its statutory goals as it resolves particular substantive issues. This implementation function includes the analytical methodologies that the agency adopts to resolve certain kinds of issues, the criteria that it employs, the factors that it considers, the range of options from which it chooses, and the policies that guide its resolution of science/policy questions that arise when the existing scientific data do not lead to firm factual conclusions.²⁸

The second two elements of the State Farm test—whether the agency’s explanation runs counter to the evidence or is too implausible—invites the reviewing court to evaluate the plausibility of the agency’s explanations of how it resolved important scientific, economic, and technical questions that arose in the process of promulgating the rule and of why it accepted or rejected material comments from outsiders.²⁹ The court’s role is to determine whether the agency’s technical explanation for how it resolved an important issue or its response to a critical outside comment is inconsistent with the evidence in the rulemaking record or is implausible by some appropriate (and judicially ascertainable) measure of plausibility.

The regulatory Daubert proposal for rulemaking review would intensify the scrutiny with which a reviewing court performs these functions. The court would carefully examine (presumably more carefully than before) whether the studies that the agency relied on were relevant to the factors that Congress deemed applicable. Courts applying a regulatory Daubert approach might conceivably examine more carefully the appropriateness of the agency’s resolution of science/policy questions as it employs scientific and policy considerations in interpreting relevant studies and drawing inferences based on those studies.

The reliability inquiry under a regulatory Daubert approach would have the court skeptically examining the agency’s formal explanation and other supporting documents to determine whether it relied on a sufficient number of scientifically reliable studies to support the conclusions arrived at in its risk assessments. If the reviewing court adhered to the corpuscular approach that characterizes Daubert review in toxic tort cases, it would not matter how many studies in the record demonstrated the existence of smoke, and it would not matter how many studies deemed scientifically invalid by the court purported to observe fire, the agency’s rule would have to be set aside if the agency did not rely upon a sufficient number of scientifically valid studies in which fire was observed.

	THE DANGERS OF DAUBERT-IZING JUDICIAL REVIEW OF RISK ASSESSMENT

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In the past, courts have resisted efforts by regulatees to Daubert-ize judicial review of risk assessment. For example, the D.C. Circuit rejected the industry’s invitation to adopt a Daubert-like judicial review of OSHA rulemaking in reviewing OSHA’s standard for worker exposure to ethylene oxide (EtO) under the substantial evidence test. The court observed that the industry trade association

attacks each piece of evidence, suggesting that no individual piece proves a relationship between EtO exposure and various adverse health effects. This approach disregards the marginal contribution that each piece of evidence makes to the total picture. While some of OSHA’s evidence suffers from shortcomings, such incomplete proof is inevitable when the Agency regulates on the frontiers of scientific knowledge. . . . OSHA need not "prove" its assertions in the manner AEOU demands. . . . Rather, OSHA need only gather evidence from which it can reasonably draw the conclusion it has reached. Our function . . . is only to search for substantial evidence, not proof positive.³⁰

Similarly, in reviewing EPA’s decision to phase tetraethyl lead out of gasoline, the D.C. Circuit stated the following:

Contrary to the apparent suggestion of some of the petitioners, we need not seek a single dispositive study that fully supports the Administrator’s determination. Science does not work that way; nor, for that matter, does adjudicatory factfinding. Rather, the Administrator’s decision may be fully supportable if it is based, as it is, on the inconclusive but suggestive results of numerous studies. By its nature, scientific evidence is cumulative: the more supporting, albeit inconclusive, evidence available, the more likely the accuracy of the conclusion. . . . Thus, after considering the inferences that can be drawn from the studies supporting the Administrator, and those opposing him, we must decide whether the cumulative effect of all this evidence, and not the effect of any single bit of it, presents a rational basis for the . . . regulations.³¹

The courts have thus sensibly refrained from playing a gatekeeper role with respect to the scientific information that agencies rely on in preparing risk assessments. This judicial reticence is altogether appropriate for several reasons. First, the courts have played a prominent role in the "ossification" of informal rulemaking and the consequent inability of regulatory agencies to fulfill their statutory missions. Not knowing how stringently a reviewing court will review the agency’s explanations and how carefully the reviewing court will probe the rulemaking record for evidence supporting critical factual underpinnings for the agency’s conclusions, the agencies tend to load up the record with huge amounts of information and to provide lengthy explanations that answer every question raised by outside commentators in scrupulous detail. The result is that agencies are not able to fulfill their congressionally delegated responsibilities. One partial solution to the ossification problem is for the courts to take an even more deferential approach to scientific rulemaking.³² Daubert-izing judicial review of risk assessment would be a move in precisely the opposite direction.

Second, the expectation of judicial review has already had an impact on the way that the agencies use science internally. Concerned about corpuscular attacks on the agency’s reasoning process, agency working groups can become dominated by a legalistic attitude that puts pressure on agency scientists to treat "scientific evidence as admissible or inadmissible, rather than taking a scientific approach to see what could be inferred from all of the available evidence."⁵ Daubert-izing judicial review can only exacerbate this tendency and render the internal decisionmaking process even less receptive to scientific nuance.

Third, judges do not always have a good sense for what is relevant in complex rulemakings. The petitioners’ briefs, which are the primary indicators of the importance of particular issues, tend to elevate trivial issues to whatever level of importance is required to convince the court that the error or failure warrants remand. Reviewing judges can, in the words of Professor Pierce, demonstrate a "remarkable instinct for the capillary" in reviewing agency rules.³³ Not knowing what trivial issue may ultimately doom a rulemaking initiative, agencies are compelled to analyze every issue in detail and to waste scarce analytical resources responding to otherwise trivial comments. Under the regulatory Daubert approach, blunderbuss attacks on every conceivable flaw in the scientific studies relied on by the agency stand a good chance of producing the desired result—a regulatory process malfunction.

Fourth, judges who come to the task with a laissez faire ideological perspective are not always as concerned with the quality of agency decisions as they are with ensuring that agencies do not encroach too deeply upon private markets.³⁴ Assigning a gatekeeper role to the courts under a regulatory Daubert regime will provide an opportunity for judges intent on reducing the federal government’s role in business activity to force agencies to be more timid in carrying out their statutory missions. Although it is unclear whether Daubert-izing judicial review will enhance the quality of agency decisionmaking, it almost certainly will result in regulations that are less burdensome to regulatees. This is precisely the outcome that most regulatees, and many judges, desire.

Fifth, Daubert-izing judicial review of agency rules will encourage lawyer-dominated attempts in scientific arenas outside the courtroom to bend science to the regulated industry’s will. The industry challenge to EPA’s risk assessment for environmental tobacco smoke (ETS) is an excellent example.³⁵ From the moment that the tobacco industry learned that an epidemiological study suggesting an association between exposure to ETS and lung cancer would soon be published in a scientific journal, the industry and its lawyers launched an all-out crusade to discredit that study and subsequent studies. Industry consultants were hired to flood the scientific journals with letters critiquing the study. Public relations consultants filled the media with attacks on the studies and statements from industry-funded scientists that the question of the health risks of ETS was still very much up in the air. Industry lawyers and sympathetic politicians attempted to determine the composition of the agency’s advisory committee, and the industry deluged the agency with a flood of industry-funded comments and criticisms of the agency’s early drafts. All of this was undertaken with the expectation that the agency would ultimately back off and write a more equivocal document, but it was also done with an eye toward litigation that would follow if the agency did not retreat.

Finally, and most importantly, by encouraging such blunderbuss attacks, regulatory Daubert judicial review will ultimately distort the science underlying health, safety, and environmental regulation by reducing the ability of agencies to take a weight-of-the-evidence approach. No study is perfect, and scientists are constantly making assessments about how the universe works on the basis of incomplete scientific information. Risk assessments are necessarily tentative, and they are frequently stated with greater confidence as additional studies help to firm up the underlying scientific foundation. If agency rules are to be based on science, agency scientists must be permitted, perhaps with the help of panels of qualified experts, to look at the entirety of the scientific database. Their analyses should not be confined to those studies that are likely to be deemed scientifically reliable by a judge at the end of an adversarial proceeding.

	CONCLUSIONS

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The predictable consequence of Daubert-izing judicial review of regulatory agency rulemaking will be an overall reduction in the protections that government provides to those who are at risk. At the very least, more stringent judicial review will result in more judicial remands. If agencies react as regulatory Daubert advocates hope they will, then risk assessments will contain better supported and more cautious conclusions. To the extent that the agencies rely upon risk assessments to support regulatory action, more cautious risk assessments should yield less stringent regulations. Thus, though Daubert-izing judicial review may or may not produce more scientifically sound agency decisions, it will almost certainly yield fewer and less stringent regulations.

The proponents of strict judicial scrutiny of health, safety, and environmental regulations have a clear normative agenda in mind. Having failed during the 104th Congress to reign in federal regulatory agencies by enacting sometimes draconian proposals for regulatory reform legislation,³⁶ regulatory reformers are now attempting to gain the regulatory relief they desire quietly in the courts by subtly assigning a more activist role to judges whom they perceive to be more sympathetic to those goals than Congress appears to be. The courts should forcefully reject this invitation to play an overtly political role in transforming protective health, safety, and environmental regulation to fit the regulated industries’ views on the proper role of federal regulation in society.

	Acknowledgments

 
This work benefited from the continuing research support of the University of Texas School of Law.

	Footnotes

 
Peer Reviewed

Accepted for publication August 10, 2004.

	References

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1. 5 USC 553.

2. 5 USC 702.

3. See Carnegie Commission on Science, Technology & Government. Risk and the Environment: Improving Regulatory Decisionmaking. New York, NY: Carnegie; 1993; Jasanoff S. The Fifth Branch: Science Advisors as Policymakers. Cambridge, Mass: Harvard University Press; 1990; Latin H. Good science, bad regulation, and toxic risk assessment. Yale J Reg. 1998;5:89–148; Majone G. Science and trans-science in standard setting. Sci Tech Hum Values. 1984;9:15–22; Scmandt J. Regulation and science. Sci Tech Hum Values. 1984;9: 23–38.

4. Krimsky S. The ‘weight-of-scientific-evidence’ in policy and law. AJPH (this issue).

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6. Environmental Protection Agency. Safeguarding the Future: Credible Science, Credible Decisions, Report of the Expert Panel on the Role of Science at EPA. Washington, DC: US EPA; 1992.

7. Environmental Protection Agency. EPA Strategic Plan. Washington, DC: US EPA; 1997; quoted in National Academy of Sciences. Strengthening Science at the US Environmental Protection Agency: Research Management and Peer Review Practices. Washington, DC: US NAS; 2000.

8. McGarity TO, Wagner WE. Legal aspects of the regulatory use of environmental modeling. Environ Law Rep. 2003;33:10751–10774.

9. Feldman HL. Science and uncertainty in mass exposure litigation. Texas Law Rev. 1995;74:1–48.

10. Solomon B. Finger-pointing distinguishes attempts to fix blame for liability crisis. Natl J. 1986;18: 378–384; Glen M. Congress joins the hue and cry over liability insurance crisis. Natl J. 1986;18: 380–381.

11. Huber PW. Galileo’s Revenge: Junk Science in the Courtroom. New York, NY: Basic Books; 1991.

12. Professor Huber’s mostly anecdotal accounts were heavily relied upon by the tort reformers, but they were harshly reviewed by academics and practitioners. See Blomquist RF. Science, toxic tort law, and expert evidence: a reaction to Peter Huber. Ark Law Rev. 1991;44:629–653; Chesebro KJ. Peter Huber’s junk scholarship. Am Univ Law Rev. 1993;42:1637–1726.

13. President’s Council on Competitiveness, Agenda for Civil Justice Reform in America. 1991;11:21–22; reprinted in Quayle D. Agenda for civil justice reform in America. Univ Cinn Law Rev. 1992;60:979–1007. Chesebro KJ. Peter Huber’s junk scholarship. Am Univ Law Rev. 1993;42:1637–1726; Green, supra note, pp. 19–22.

14. Daubert v Merrell Dow Pharmaceuticals, Inc, 509 US 579 (1993); Sanders J. The Bendectin litigation: a case study in the life cycle of mass torts. Hastings Law J. 1992;43:301–418, 391.

15. Beecher-Monas E. The heuristics of intellectual due process: a primer for triers of science. NYU Law Rev. 2000;75:1563–1657, 1637.

16. Finley LM. Guarding the gate to the courthouse: how trial judges are using their evidentiary screening role to remake tort causation rules. DePaul Law Rev. 1999;49:335–376, 341–342; Gottesman MH. From Barefoot to Daubert to Joiner: triple play or double error? Ariz Law Rev. 1998;40:753–780, 756–759.

17. Daubert v Merrell Dow Pharmaceuticals, Inc, 509 US 579,593–595 (1993).

18. General Electric Co v Joiner, 522 US 136, 146 (1997).

19. Federal Rules of Evidence 702. The Advisory Committee Notes state that Rule 702 was amended "in response to" Daubert and "to the many cases applying Daubert."

20. McGarity TO. On the prospect of "Daubertizing" judicial review of risk assessment. Law Contemp Prob. 2003;66:155–225; Finley LM. Guarding the gate to the courthouse: how trial judges are using their evidentiary screening role to remake tort causation rules. DePaul Law Rev. 1999;49:335–376, 341–342; Cutler JD. Implications of strict scrutiny of scientific evidence: does Daubert deal a death blow to toxic tort plaintiffs? J Environ Law Litig. 1995;10:189, 214–220; Sanders J. The Bendectin litigation: a case study in the life cycle of mass torts. Hastings Law J. 1992;43:301–418, 391.

21. Brown H. Eight gates for expert witnesses. Hous Law Rev. 1999;36:743–882.

22. Elliott ED, Raul AC, Pierce RJ Jr, McGarity TO, Wagner WE. Science, agencies, and the courts: is three a crowd? Environ Law Rep. 2001;31:10125–10140; Truong DH. Daubert and judicial review: how does an administrative agency distinguish valid science from junk science? Akron Law Rev. 2000;33:365–390; Weller CD, Graham DB. New approaches to environmental law and agency regulation: the Daubert litigation approach. Environ Law Rep. 2000; 30:10557–10573, 10566–10572.

23. Elliott ED, Raul AC, Pierce RJ Jr, McGarity TO, Wagner WE. Science, agencies, and the courts: is three a crowd? Environ Law Rep. 2001;31:10125.

24. McGarity TO. On the prospect of "Daubertizing" judicial review of risk assessment. Law Contemp Prob. 2003;66:155–225.

25. Brown H. Eight gates for expert witnesses. Hous Law Rev. 1999;36:743–882; Gottesman MH. From Barefoot to Daubert to Joiner: triple play or double error? Ariz Law Rev. 1998;40:753–780, 756–759; Beecher-Monas E. The heuristics of intellectual due process: a primer for triers of science. NYU Law Rev. 2000;75:1563–1657, 1637; Finley LM. Guarding the gate to the courthouse: how trial judges are using their evidentiary screening role to remake tort causation rules. DePaul Law Rev. 1999;49:335–376, 341–342; Sanders J. The Bendectin litigation: a case study in the life cycle of mass torts. Hastings Law J. 1992; 43:301–418, 391. At least one post-Daubert court has explicitly rejected an expert’s conclusions based on a weight-of-the-evidence approach; see Allen v Pa. Engineering Corp, 102 F3d 194,196–198 (5th Cir 1996).

26. Bonine J, McGarity T. The Law of Environmental Protection: Cases, Legislation, Policies. 2nd ed. St. Paul, MN: West, 1992.

27. Motor Vehicles Manufacturers Association v State Farm Mutual Automobile Insurance Co, 463 US 29,43 (1983).

28. Applegate JS. The perils of unreasonable risk: information, regulatory policy, and toxic substances control. Columbia Law Rev. 1991;91:261–333; Hornstein DT. Reclaiming environmental law: a normative critique of comparative risk analysis. Columbia Law Rev. 1992; 92:562–633; Wagner WE. The science charade in toxic risk regulation. Columbia Law Rev. 1995;95: 1613–1723.

29. Portland Cement Association v Ruckelshaus, 486 F2d 375, 386 (DC Cir 1973); International Harvester Corp v Ruckelshaus, 478 F2d 615, 633 (DC Cir 1973); Kennecott Copper Corp v EPA, 462 F2d 846, 849 (DC Cir 1972).

30. Public Citizen Health Research Group v Tyson, 796 F2d 1479,1495 (DC Cir 1986).

31. Ethyl Corp v EPA, 541 F2d 1,37–38 (DC Cir 1976) (en banc).

32. McGarity TO. Some thoughts on "deossifying" the rulemaking process. Duke Law J. 1992;41:1385–1462, 1453.[CrossRef]

33. Pierce R. Unruly judicial review of rulemaking. Nat Resources Environ. 1990;5:23–50,23–24.

34. Gulf S. Insulation v Consumer Product Safety Commission, 701 F2d 1137 (5th Cir 1983); see also Ashford N., et al. A hard look at federal regulation of formaldehyde: a departure from reasoned decisionmaking. Harv Environ Law Rev. 1983;7:297–370, 368; Latin H. Good science, bad regulation, and toxic risk assessment. Yale J Reg. 1989;5:89–148, 131.

35. The ETS story is recounted in detail in McGarity TO. Daubertizing judicial review. Law Contemp. Prob. 2003;66:155–225, 178–225.

36. McGarity TO. Deflecting the assault: how EPA survived a "disorganized revolution" by "reinventing" itself a bit. Environ Law Rep. 2001;31:11249–11265; Buzbee WW. Regulatory reform or statutory muddle: the "legislative mirage" of single statute regulatory reform. NYU Environ Law J. 1996;5:298–381.

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