title: Public participation in data audits.
abstract: The United States in the early 1980s faced a crisis of confidence in the institutions that it had created to protect public health and the environment from the risks posed by toxic chemicals. Although the political climate of the times had a lot to do with the loss of public confidence in agencies like the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) and the Occupational Safety and Health Administration (OSHA), perhaps the most profound crack in the institutional edifice was the revelation that much (or at least some, depending upon whom you believed) of the scientific basis for past health and environmental decisions was grounded in invalid and even fraudulent health and safety studies. The IBT scandal (named after the Industrial Biotest Laboratories whose misadventures ultimately resulted in jail sentences for its officers) fueled accusations that the health and environmental agencies could not be trusted to reign in the chemical industry.(1) Public apprehensions were hardly quelled by the revelation in late 1982 that EPA had assigned only one full-time professional to audit the performance of all pesticide testing laboratories for evidence of additional fraud or misreporting.(2) It is fair to conclude that the recent trend toward establishing procedures for independent audits of health and safety data is a direct response to the crisis of public confidence resulting from the IBT scandal. Both EPA and FDA have promulgated "Good Laboratory Practice"; guidelines that serve as a baseline for such audits, and an increasing number of firms have established new "quality assurance"; controls to insure the agencies (and themselves) that the scientific underpinnings of health and safety decisions are sound. There is little reason to conclude, however, that this more-or-less unilateral response to the IBT scandal will by itself stem public distrust in health and safety decisionmaking. Knowledgeable members of the public will not trust the agencies until they know that they can trust the audits, and they will not trust the audits until they begin to trust the auditors. This resurrects the ages-old conundrum: Who shall guard the guardians? Representatives of public interest groups, such as the Natural Resources Defense Council, Inc. and Ralph Nader's Public Citizen Health Research Group, have an easy answer to this question. They strongly believe that the only way to ensure the integrity of the scientific basis for health and safety decisionmaking is to spread all aspects of health and safety studies fully on the public record for all to see.(1) Representatives of the pharmaceutical and chemical industries, however, complain that this solution would expose valuable trade secrets to easy appropriation by unscrupulous competitors, thereby reducing industry incentives to develop new drugs and chemicals. Herein lies the core of a debate that has animated more than one congressional hearing and has reached all the way to the Supreme Court in recent years. This paper will examine the arguments for and against affording trade secrecy protection to health and safety testing data and apply those policies to the specific question of data audits. Finally, it will suggest a way to resolve the problem that enhances public trust in the audits while at the same time minimizing any disincentives to innovate.
authors: a William Stamps Parish Professor of Law , University of Texas School of Law , Austin , Texas , 78705.
authors: T O
authors: TO
authors: McGarity
keywords: Public health; environment; fraudulent studies; public confidence; risk; safety and health; toxic chemicals