Shaping Science and Technology Policy: The Next Generation of Research

5. EPA's Drinking Water Standards and the Shaping of Sound Science

Introduction Charged with incorporating “sound science” into its policy decisions, the U.S. Environmental Protection Agency (EPA) has been embroiled in intense scientific disputes about the regulation of chemicals to protect public health. These conflicts underscore the dependence of the agency’s reputation on its scientific credibility based on the presumed authority of science (Smith 1992). In the regulatory arena, scientific expertise is often idealized: “Science seeks truth; science pursues objective knowledge ; science is not influenced by political interests or short-term considerations or emotion. Science, in other words, is supposed to be everything that politics is not” (ibid. 74). Operating under tensions and constraints imposed by its regulatory environment, EPA uses a type of science referred to as “regulatory science”—scientific knowledge created specifically for regulatory purposes , under time and political restrictions ( Jasanoff 1990). Unlike socalled research science, which is open-ended with extended timelines, regulatory science is subject to statutory and court-ordered timelines. 102 5 EPA’s Drinking Water Standards and the Shaping of Sound Science  .  While research science is based on peer-reviewed papers published in esteemed journals, regulatory science often relies on unpublished studies or “gray literature.” Yet regulatory science is held accountable to Congress, courts, and the general public. Within the American regulatory milieu, three key constraints directly impact EPA’s ability to incorporate science into regulatory development : (1) regulatory procedures (2) requirements for openness and transparency, and (3) judicial intervention. As this chapter illustrates, these constraints hamper the agency’s ability to assess science and make regulatory decisions. Most EPA rulemaking follows the so-called informal or notice and comment procedures specified in §553 of the Administrative Procedures Act (APA). These requirements include timelines, public notification, and public comment periods. They prolong the rule-making process, which averages four years at EPA (Kerwin and Furlong 1992). American requirements for openness in the regulatory process are rooted in the need for public accountability. William Ruckelshaus, EPA’s first administrator, stated, “I am convinced that if a decision regarding the use of particular chemicals is to have credibility with the public and with the media . . . then the decision must be made in the full glare of the public limelight.”1 EPA is subject to the Federal Advisory Committee Act (FACA), which requires that advisory committee activities be open to the public. Perhaps the single most significant aspect of the American regulatory context is the activist role of the courts, which have the ability and the willingness to intervene in agency rule making ( Jasanoff 1995; Kagan 2001). The courts ensure that agencies interpret statutes according to legislative intent, properly follow procedural requirements, and do not exceed statutory authority (Levine 1992). Under the APA (§706), agency rule making is subject to judicial review if agency actions are (1) “unlawfully withheld or unreasonably delayed;” (2) “arbitrary, capricious , an abuse of discretion, or otherwise not in accordance with law;” (3) “without observance of procedure required by law;” or (4) “unwarranted by the facts.” Traditionally, the courts granted administrative agencies substantial deference in technical matters. For example, Judge Bazelon advocates judicial deference to agencies in technical matters: “Where administrative decisions on scientific issues are concerned, it makes no sense to rely upon the courts to evaluate the agency’s scientific and technological Franklin: EPA’s Drinking Water Standards 103 determinations; and there is perhaps even less reason for the courts to substitute their own value preferences for those of the agency” (Bazelon 1977, 822). In contrast, the “hard look” doctrine supports greater judicial oversight over agency decisionmaking (McSpadden 1997). For example, Judge Levanthal believes that the courts have “a supervisory function” over agency decisionmaking, including review of the rationale for technical decisions (Leventhal 1974, 511). Since EPA’s founding, the courts have played an increasingly active role in regulatory actions (O’Leary 1993; Jasanoff 1995; Kagan 2001). Litigation is “an ordinary, rather than an extraordinary, part of the overall administrative process” (O’Leary 1993). A significant fraction of EPA’s major regulations are challenged in courts (Coglianese 1996; Kerwin 1994). Two Supreme Court cases have established important, yet somewhat contradictory, precedents regarding regulatory decisionmaking . The landmark 1984 Supreme Court decision in Chevron v. NRDC holds that if a statute is ambiguous, the judiciary must defer to any reasonable interpretation offered by the agency.2 Yet in Daubert v. Merrill Dow Pharmaceuticals, the Court ruled that judges, rather than juries or scientific institutions, should determine the appropriateness of expertise...