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Keeping Pace with Science and Engineering. 1993. Pp. 1-7. Washington, DC: National Academy Press. Introduction: Environmental Regulation and Changing Science and Technology Robert M. White Accommodating environmental regulation is in many cases an engi- neering task that can add significant costs in the production of goods and services as it protects environmental values. How such costs are distributed is itself a contentious issue, as amply demonstrated by the estimate of costs of the recent amendments to the Clean Air Act. When environmental regu- latory costs turn out in retrospect to have been unwarranted because regula- tory decisions were based on inadequate or inaccurate scientific informa- tion, it's only natural to express concern, since costs will have been borne without deriving the projected environmental benefits. The question under discussion in this volume how does changing sci- entific, engineering, and economic understanding precipitate reconsidera- tion of earlier environmental decisions? lies behind current headlines about environmental issues. For example, the New York Times for Sunday, 7 February 1993, carried a thoughtful article on the proposals of the new EPA administrator, Carol Browner, to reconsider the Delaney Clause, the part of the Federal Food, Drug, and Cosmetic Act that strictly bans from food any substance that has been shown to cause cancer in laboratory animals. Since its passage, the technology for measuring trace substances in food has im- proved tremendously, and we have become much more sophisticated in our This paper was prepared in close collaboration with Myron F. Uman, who served as project officer for this symposium. Dr. Uman is assistant executive officer for special projects of the National Research Council.

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2 ROBERT M. WHITE understanding of risks. We now appreciate more fully that difficult trade- offs must be made among alternative risks and that some risks are not unreasonable to accept. According to newspaper reports, Ms. Browner be- lieves that the time has come to change the Delaney Clause in light of current understanding. In a recent editorial in Science magazine, Phil Abelson wrote about the phenomenon of "regulation gone amok."2 He quoted some statistics that I found mind-boggling. He pointed out that there are 59 regulatory agencies with about 125,000 employees at work on 4,186 pending regulations. lIe also reported that the fastest growing component of regulatory costs is envi- ronmental regulation, which in 1991 amounted to $115 billion and is slated to grow by more than 50 percent by the year 2000. Abelson's concern was directed not at the costs of regulation per se, but at the costs of regulations that, on the surface, appear to be unwarranted in light of the benefits derived. Abelson cites as an example the application of national standards for contaminants in drinking water with results that ap- pear nonsensical under certain local conditions. One locality is being re- quired to make large investments in equipment to remove contaminants from water that already meets the standards for those substances. Abelson's editorial touches on the difficulty of applying national stan- dards across a diverse country. Issues of this type arise in two of the case studies presented in this volume, one on compliance strategies for meeting ambient ozone standards in urban areas across the country, and the other on meeting ambient water quality standards in Chesapeake Bay. The conflicts between national standards and regionally variable implementation raise important issues in their own right. For current purposes, however, I only raise them to illustrate the potentially enormous implications of environ- mental regulations-and hence the importance and difficulty of making sound . . decisions. I write of these issues as one who has been in the trenches administer- ing regulatory processes. In one of my previous incarnations, as the first Administrator of the National Oceanic and Atmospheric Administration, I was the responsible federal official for regulation of the U.S. ocean fisheries and of other living marine resources. Although fisheries management and protection of marine mammals constituted only 10 percent of our budget, regulatory oversight and its attendant political ramifications occupied 80 percent of my time. Regulating the take of fish or protecting porpoises and whales, like all presumably rational environmental regulation, is a matter of weighing sci- entific information about causes and effects against legislated criteria for regulatory action. Legislated criteria are generally an amalgam of scientific knowledge and the value judgments of our representatives in the legislature. In the real world, uncertainty clouds not only the scientific interpretation of

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INTRODUCTION 3 - the evidence and the economic and social costs of action but also the inter- pretation of the intent of the law. Lurking, ready to pounce on decisions whichever way they go, are the affected constituencies. Depending on the intensity of public concern and the political clout of the various parties at interest, the consequences for the regulator can be unenviable, not to mention the consequences for the envi- ronment and the affected constituencies. While the kinds of regulatory decisions that I had to make were differ- ent in some cases from the regulation of toxic emissions or effluents, we also were confronted by the infamous "mercury in fish" scare. The cause was believed to be heavy-metal discharges by industry into the oceans. In the West Coast halibut fishery, the result was the prohibition on the take of fish above a certain size because the concentration of heavy metals in fish increases with age and size. The same was true for swordfish. By examin- ing museum specimens, however, we later found, except in certain circum- stances, such as at Minamata, that the mercury in ocean fish was not a result of industrial pollution of the oceans but reflected natural levels. The environmental case studies presented in this volume reflect the dilemma of regulation in the face of uncertain and changing scientific knowledge. I would like to probe this dilemma more thoroughly. On the one hand, all regulatory policies promulgated legislatively or by executive actions are based on scientific and technical information that is only a snapshot of our knowledge at the time of decision. Our scientific understanding and our technologies for measurement or remediation are continuously changing, however, sometimes at a very rapid rate, unfettered and uninfluenced by the politics of the moment or constituency concerns except as politics might affect federal funding for research and develop ment. Regulation, on the other hand, changes slowly. This is true not only because of the ponderous nature of the legislative and regulatory process, but also because constituencies who have achieved real or imagined gains fear losing them if regulations are conformed to the latest scientific infor- mation. The institutions that must comply with regulations, such as indus- try, value regulatory stability highly because the overall costs of compliance can be increased by rapid changes in understanding and technology. We are all familiar with the cases in which new understanding or tech- nological approaches have revealed that regulation should be changed in some cases tightened and in others loosened. Lead is the classic example in which our improved scientific understanding of health effects and our in- creased ability to measure ever-lower concentrations have resulted, and ap- propriately so, in more comprehensive regulation of lead in all human ac- tivities in fuels, paints, pipes, dinnerware, etc. In other cases, improved

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4 ROBERT M. WHITE understanding has revealed that perhaps earlier regulatory actions have over- estimated risks. The cases of asbestos and perhaps dioxin come to mind. What is to be done? Regulatory actions have vast implications for human health, the quality of the environment, and economic and social welfare. We need to ask how effective are the mechanisms and procedures that have been incorporated into the regulatory process to enable it to keep pace with our scientific understanding and technological capabilities. A host of questions face any regulatory process. Which data shall be accepted for evaluation? What endpoints are appropriate measures of harm? Who is best qualified to provide independent evaluation of the available data? What evaluation processes are the most desirable? How should the results of these evaluations be expressed? And the process is plagued by uncertainties in our understanding of hazards, risks, costs, and benefits. In environmental regulatory affairs, we frequently are confronted with data for which neither the level of precision nor the level of accuracy is particularly high. Physicists may know the value of the speed of light to eight or nine significant digits, but in environ- mental affairs, we must often deal with uncertainties in the first or at best the second significant digit. One reason that uncertainties are high is that environmental regulations address issues at the cutting edge of current scientific understanding. They address issues in which the representativeness of data and measurements are under question. As time goes on, new data are collected and help to im- prove our understanding and occasionally change it radically. New mea- surement techniques allow us to detect the presence of contaminants at lower concentrations than earlier methods did or to gauge their more subtle effects. Both the techniques and the data they produce are likely to be subject to interpretation, and there may be legitimate differences among interpretations, each with different implications for regulatory decisions. Each party to the regulatory process therefore wants to be sure that the available data are properly reviewed and evaluated. While there may be differences among the parties in their attitudes about what constitutes proper review and evaluation, no one argues that the data ought not to be subject to this scrutiny, which presumably results in a body of technical evidence that represents the best that is available at a given time. As I have already indicated, the body of evidence on which a regulatory decision is based our understanding of the scientific data, engineering ca- pabilities, and economic consequences of alternative actions is dynamic. As a rule, scientists, engineers, and economists strive continuously to refine this understanding. As we improve in our ability to measure causes and effects, or to design alternative production or pollution abatement technolo- gies, or to assess consequences, it is likely that sooner or later the time will

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INTROD UCTION s come when the technical basis for a particular decision no longer represents the best available scientific, engineering, or cost data. Some national environmental legislation recognizes the dynamic nature of the technical basis for regulation. In some cases, it mandates research and development programs to improve the data base. In other cases, it provides incentives for the development of new, more cost-effective tech- nology. In still other cases, legislation explicitly includes schedules for reconsidering specific regulatory decisions. The National Academies of Sciences and Engineering have been in- volved in such periodic reviews. In the early 1970s, when the stratospheric ozone layer was thought to be threatened by the NOX emissions of super- sonic aircraft, a substantial stratospheric research program was initiated by the Department of Transportation and several other agencies. The Acad- emies were asked to help with a series of biennial assessments of the latest scientific knowledge of stratospheric ozone and the causes of its variability. The sequence of those reports revealed the changing nature of our under- standing of the photochemistry of the stratosphere and the effects of nitro- gen and chlorine on stratospheric ozone concentrations. Because our under- standing of the chemical and physical processes was changing rapidly at that time, the best estimates from several successive assessments lay outside the error bars of the previous respective assessment. No wonder policymakers were confused and reluctant to act, until the so-called ozone hole was ob- served over Antarctica. Another set of issues arises when the government organizes large scien- tific and technological research programs to improve the basis for decision making. The acid rain case is an excellent example of an attempt by the Congress through legislation to develop the necessary scientific knowledge on which to base recommendations. The National Acid Precipitation As- sessment Program (NAPAP) began in the early 1980s with all the best inten- tions. Hundreds of millions of dollars were invested in improving under- standing of the causes and consequences of acid rain. Our understanding of acid rain was greatly improved, but it is not at all clear that NAPAP pro- vided, on a timely basis, the relevant information that Congress wanted in order to set acid precipitation policy. It is well and good that we want to base environmental regulations on the best available technical understanding, but we need to recognize that that understanding is inherently dynamic. We need to build into the struc- ture of the regulatory system means for reconsidering earlier decisions if and when our understanding changes sufficiently to call earlier decisions into question. On the other hand, it is impractical to attempt to revise regulations continuously in response to new, presumably better data. For one thing, the decision-making process itself is very demanding of the time, energy, and other resources of both the regulatory agency and the affected , _~

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6 ROBERT M. WHITE parties. Much effort, including independent reviews and often intense ne- gotiations among the parties, goes into the effort. We cannot afford the continuous and considerable commitment of resources required. Perhaps more important, as desirable as it is to have regulations that are based on the best, most current technical understanding, it is also desirable to have a stable regulatory regime within which the affected parties can intelligently plan to come into compliance and implement their plans. If they know what is expected of them, most firms will strive to comply. However, doing so not only takes time but also involves capital expense. Within their frameworks for planning and executing capital investments in pollution abatement technology or alternative production processes or prod- uct formulations, regulated industries prefer-and deserve predictable regula- tory regimes. We have then two characteristics that we all would agree the environ- mental regulatory system should exhibit: it should keep pace with changes in our understanding of the technical aspects of the issues, and it should remain stable on a time scale sufficient for regulated parties to comply with some measure of economic efficiency. It is evident that these two norma- tive characteristics can be, and frequently are, in conflict. It is not unusual for scientific discoveries or economic conditions to change our understanding of the relative risks, benefits, and costs of regula- tion faster than industry can innovate, develop, and install improvements in pollution control or production technologies. We may not be able to predict when our technical understanding will change, but we can reasonably pre- dict that occasions will indeed arise in which it changes much more quickly than we might have thought and more quickly than can be readily accom- modated by affected parties. How quickly or on what time scale should we either expect or accept changes in regulation as a consequence of new scientific, engineering, or economic understanding? Is there a threshold for change, an accumulation of new understanding which, when reached, should trigger a response by the regulatory system? When is the legitimate desire of the regulated indus- try for stability an appropriate barrier to change? The primary question of policy is this: Does the current environmental regulatory system strike an appropriate balance between dynamic change and stability? As my colleagues and I thought about this question, we discovered to our surprise that while the regulatory combatants have "war stories" to tell, there have been few, if any, attempts to analyze how the system has been working in practice. We know, for example, that the national ambient air quality standards for the criteria pollutants have not been reviewed on the five-year cycle that is mandated in the Clean Air Act. Why? Is it because new data or improved technical understanding has not developed on this time scale, or because the .

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INTRODUCTION 7 affected industries need longer periods over which the standards remain constant, or because the investments of time, personnel, and other resources- including political capital-are too great to repeat the decision-making pro- cess this frequently? Should this provision of the Clean Air Act be changed? To take another example, several pieces of environmental legislation contain provisions that, at the time they were adopted, were intended to provide incentives for innovation in pollution control technology. The de- velopment and demonstration of improved technology were thought to com- pel reconsideration of performance standards for abatement, at least in some cases. Did the provisions work as intended? When many of these provisions were enacted, the technological focus in environmental affairs was on pollution control, that is, on end-of-pipe treatment. More recently, the focus has been on pollution prevention, that is, on product reformulation or process redesign. How does this change in focus affect regulatory decision making on performance standards? Are changes warranted in the provisions themselves? This volume is about keeping pace with changing technical understand- ing in environmental regulation. Its purposes are to shine a spotlight on the competing demands for keeping regulations in step with current knowledge and for maintaining regulatory stability and to serve as a catalyst for further consideration of and debate about the appropriate balance between these goals. My hope is that the case studies and essays in this volume will stimulate additional analytic examination of current policies and past prac- tices, leading to a better understanding of whether the current regulatory system does about as well as can be expected or, if not, what alternatives might be considered. NOTES 1. Keith Schneider. A trace of pesticide, an accepted risk. The New York Times, 7 February 1993. 2. Philip H. Abelson. Regulatory risks. Science 259(8 January 1993):159. _