The complementary roles of common law courts and federal agencies in producing and using policy-relevant scientific information.

• Author: McGarity, Thomas O.
• Position: Symposium

1. INTRODUCTION II. SCIENTIFIC INFORMATION IN REGULATORY AGENCIES A. Adverse Effects Reporting Requirements B. TSCA Testing Rules III. SCIENTIFIC INFORMATION IN COMMON LAW COURTS IV. A CASE STUDY IN COOPERATION A. Teflon, C-8, and other Perfluorinated Compounds B. 3M Gets Out of the Business C. DuPont Expands Its Business D. EPA Acts E. DuPont's Litigation Woes F. The Scene Shifts Back to EPA V. THE ADVANTAGES OF COOPERATION VI. IMPEDIMENTS TO COOPERATION A. Agency Impediments B. Common Law Impediments C. Protective Orders and Sealed Settlements VII. TOWARD GREATER COOPERATION IN THE FUTURE A. Ease the Burden on EPA Test Rules B. Easier Access to Agency Information through FOIA or Posting on the Internet C. Change the Rules of Practice to Allow Parties to Provide Information to Agencies VIII. CONCLUSION I. INTRODUCTION

   Beginning in the early 1970s, Congress empowered federal agencies, like the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration, and the Food and Drug Administration, to protect human health and the environment from a variety of risks posed by useful consumer products and less useful activities that result in discharges of pollutants into the nation's air and water. The agencies implement their often overwhelming responsibilities by promulgating rules governing private conduct or, in some cases, by approving products for public marketing. To assess the risks posed by such products and activities properly, these agencies rely upon scientific information from a variety of sources ranging from published scientific articles to unpublished reports from regulatees on the results of product testing to adverse effects reports indicating that particular products or activities pose unacceptable risks. (1) The agencies have become repositories of huge amounts of scientific information that they may use in taking regulatory action or disseminate to the public by way of warnings or cautionary statements.

   Common law courts entertaining products liability and toxic tort claims rely upon the same kind of scientific information in 1) assessing whether the defendant's products are defective or its activities subject workers or neighbors to unreasonable risks and 2) determining whether the defendant's products or activities caused damage to the plaintiff. Defendants in such actions are often subject to federal regulatory requirements as well, and they can provide the courts with the same information that they supply to the agencies. (2) Private litigants can also commission their own studies and hire experts to assess and opine on the scientific literature. (3) Unlike regulatory agencies, litigants can also dig through the files of the opposing parties in an effort to uncover additional scientific information and evidence that they may or may not have shared with the appropriate regulatory agencies. (4) The situation therefore offers the potential for cooperative sharing of scientific information between regulatory agencies and common law courts. (5) Relying on a case study of the regulatory and litigation history of the ubiquitous chemical compound perfluorooctanoic acid (PFOA), this Article probes that potential and the impediments that stand in the way of its full realization.

2. SCIENTIFIC INFORMATION IN REGULATORY AGENGIES

   Agencies can draw on a wide variety of sources of scientific information to use in promulgating rules and regulating products. Agency staff with expertise in the relevant scientific disciplines can comb the published literature for relevant studies. During the rulemaking process, agencies ask members of the public to provide any information they possess that might be relevant. (6) This typically yields large submissions from the regulated entities and sometimes from nongovernmental public interest groups. (7) In the context of product licensing, the primary source of agency information, however, is neither the published scientific literature nor public comments. It is the entity that is seeking the agency's approval to market the product. Submitters of health and environmental information in these contexts typically claim that the information is "trade secret" or "confidential business information" that the agency may not disclose to the public. (8) Finally, agencies can commission their own health and environmental studies. (9) Although some agencies have modest research budgets, very few of those very limited dollars go into health and environmental testing and analysis. (10)

   1. Adverse Effects Reporting Requirements

      Several health and environmental statutes require regulatees to report to the relevant regulatory agency any information they acquire indicating their products or activities may have a significant adverse effect on human health or the environment. (11) In particular, section 8(e) of the Toxic Substances Control Act (TSCA) requires any manufacturer, processor, or distributor of a chemical substance who has "information which reasonably supports the conclusion that such substance ... presents a substantial risk or injury to health or the environment" to "immediately inform" EPA of such information, unless the agency has already been adequately informed of the information. (12) Since this very broad requirement is backed up by criminal penalties, (13) it should have a profound impact on a company. It is, however, very difficult to enforce, and what little evidence exists suggests that noncompliance rates are high. According to Professor Arnold Reitze's treatise, the adverse effects reporting requirements are at the bottom of EPA's list of regional inspections. (14)

   2. TSCA Testing Rules

      A few agencies have the authority to require regulatees to conduct scientific testing to evaluate the health and environmental risks posed by their products and activities. The most comprehensive of these testing authorities is section 4 of TSCA, which authorizes EPA to order manufacturers of new or existing chemical substances to test those substances. (15) If EPA can support one of several findings, it may promulgate an appropriate testing rule. First, EPA may require testing if it finds that the manufacture, distribution, or other covered uses of a chemical substance "may present an unreasonable risk of injury to health or the environment," that "there are insufficient data and experience upon which the effects" of the chemical "on health or the environment can reasonably be determined or predicted," and that "testing ... with respect to such effects is necessary to develop such data." (16) Alternatively, EPA may base a testing rule on a finding that the substance "will be produced in substantial quantities" and either "enters or may reasonably be anticipated to enter the environment in substantial quantities" or "there is or may be significant or substantial human exposure to such substance." (17) Finally, if "there are insufficient data and experience upon which the effects" of the chemical "on health or the environment can reasonably be determined or predicted," then "testing ... with respect to such effects is necessary to develop such data." (18) The statute also creates an Interagency Testing Committee (ITC), composed of representatives of several federal agencies, to nominate for testing chemicals that meet this multi-faceted threshold test. (19) Once a chemical appears on the ITC "priority list" of fifty chemicals, EPA must in theory decide within one year whether to issue a rule ordering further testing. (20)

      Surprisingly, EPA has exercised this power quite sparingly. Instead of initiating rulemaking actions, it tends to invite manufacturers to meetings with agency staff to negotiate about the nature and extent of additional testing that needs to be done. (21) These negotiations can drag on for years, and they do not always result in especially stringent testing requirements. Former Assistant Administrator Lynn Goldman admits that EPA is "quite gun shy" when it comes to regulating under TSCA, and points out that "[w]hen you don't have the ability to regulate in your armamentarium, you are in a very weak negotiating position." (22) The Government Accountability Office concluded that "EPA does not routinely assess the human health and environmental risks of existing chemicals and faces challenges in obtaining the information necessary to do so." (23) As of 1998, at least one-third of the toxic chemicals produced in the highest volumes still failed to satisfy minimal data requirements. (24)

3. SCIENTIFIC INFORMATION IN COMMON LAW COURTS

   Many kinds of products liability claims and most toxic tort claims at common law demand large amounts of scientific information. Ordinarily, plaintiffs need such information to establish a cause-effect relationship between exposure to a toxic product or discharge and actual damage to the plaintiffs health or economic well-being. (25) Common law courts do not have the power to order private entities to conduct testing. Since the burden of proof in common law cases is on the plaintiff, it behooves plaintiffs' attorneys to identify existing studies or commission new ones to be presented to the fact-finders through the testimony of qualified experts. (26) Like agency staffers, experts for plaintiffs can pour through the existing scientific literature, but they do not always have the same access to the information that companies provide to regulatory agencies for reasons that we shall probe below. Unlike agencies, plaintiffs' attorneys have a strong incentive to probe another source of information--the files of the companies (frequently the same companies that the agencies regulate) for scientific information and, importantly, for evidence that the companies knew in advance of the risks that their products and activities posed to the attorneys' clients.

   In the now famous case of Daubert v. Merrell Dow Pharmaceuticals, Inc., (27) the Supreme Court seized an opportunity to address complaints from traditional...