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5 ELR 50179 | Environmental Law Reporter | copyright © 1975 | All rights reserved Regulation and Health: How Solid is Our Foundation?Edward J. Burger, Jr. Dr. Burger was a member of the staff of the Office of Science and Technology in the Executive Office of the President between 1969 and 1973.The ideas expressed in this paper reflect the views of the author and do not necessarily represent the opinions of the Science Adviser nor of the National Science Foundation. Introduction On January 28, 1975, the United States Court of Appeals for the District of Columbia ruled that the EPA regulation to reduce the level of tetraethyl lead in gasoline was arbitrary and capricious. Within only slightly more than a month, the Environmental Protection Agency itself reversed a previously held position concerning the schedule for clamping down on automotive exhaust emissions. The reversal was occasioned, it was said, because of the likelihood of sulfuric acid mist emissions from the catalytic devices necessary to meet the more restrictive standards. Each of these decisions was inevitably seen in some quarters as a setback for the cause of preserving environmental integrity. There were other, and perhaps, more fundamental ramifications as well. These two moves — one by the judiciary and one by the executive — both reflected earlier decisions taken on the basis of exceedingly thin scientific fabric. Thus, these represented the latest (yet probably not the last) examples of bringing the scientific basis for a regulatory decision under more careful scrutiny than was exercised when the decision was originally made. In the case of tetraethyl lead, the majority opinion found that "… the evidence does not support the EPA's health concern and … the case against auto lead emissions is a speculative and inconclusive one at best."1 In the case of automotive emissions, the Administrator of EPA declared that the Agency had "… made a mistake …" earlier in its initial decision to rely on the catalytic exhaust device.2 The lead and the exhaust catalyst issues indicate what is well-known within the scientific fraternity but, perhaps, poorly recognized by the public at large. That is, in general, the fund of scientific knowledge available for health-related regulatory decisions for such items as pesticides, air pollutants or food additives is exceedingly poorly stocked — both in quantity and quality. The investments made in behalf of accretion of knowledge for this area, both monetarily and in terms of sophistication of inquiry, are much less than the importance of the decisions would dictate. Further, the capacity of science to contribute is much greater than has been permitted up to now. As a nation, we are at peril in several ways because of the inadequate storehouse of information. Regulation to prevent human exposure to noxious and harmful chemical and physical agents in the environment represents a tangible and achievable opportunity of preventive medicine. Yet, because of the severe lack of basic understanding, we will inevitably err in both directions of missed opportunities and overly zealous but ultimately unproductive regulatory actions. Further, the very nature of the decisions and the expenditures they imply should dictate that they be girded up with a sound scientific rationale. (This last point, of course, has become increasingly repeated as the nation has been forced to take stock of its economic well-being). This prominent lack of scientific information for regulatory decisions reflects a lack of support for the investments in research and analysis necessary to provide sound information. Ultimately, it is the result of a curious phenomenon of a seeming conflict in practice between the political science of regulation and science for regulation. The net result of this pattern will ultimately be a combination of questionable decisions and, probably, an increasing lack of confidence in the regulatory process. The case for assuring an adequate knowledge base is a compelling one and the growing breadth of governmental decision proceses attests to the importance of the research activity. The opportunity for prevention is particularly large and attractive. In the United States, the crude death rate in 1900 was 17.2 per 1000 population. This rate fell rairly consistently through the first half of the twentieth century and by 1960 was 9.5 per 1000. (Figure 1). Between 1900 and 1960, large relative declines in mortality took place during infancy and childhood. In absolute terms, however, the declines in mortality at older ages were also substantial. Various deviations from this trend can be traced to epidemics of infectious disease which occurred from time to time before the 1940's. Substantial changes have taken place in the rank ordering of causes of death by disease category. Notable has been the relative decline in importance of infectious diseases as compared to chronic degenerative diseases (cancer, diseases of the heart, arteriosclerosis, cirrhosis). (Figure 2) In 1900, diseases of the heart caused eight per cent of the deaths in the United States and cancer caused less than four per cent. By 1960, influenza and pneumonia were the only infectious diseases ranking [5 ELR 50180] in the top ten causes of death. (Together, these amounted to less than four per cent in 1969). At the same time by 1960 diseases of the heart were responsible for 39 per cent of all deaths and cancer for over 15 per cent. Most important, these increases were substantially greater than could be accounted for by the decreases in deaths from infectious diseases and the increased portion of the population reaching advanced age. Thus, while cancer, for example, has "taken the place" of other causes of death, the increased age and size of the population does not entirely explain the increase in cancer deaths since 1900.3 The environmental contribution to human cancer in general is believed to be possibly quite large.4 CRUDE DEATH RATES IN 1900-1960 PER 1000 POPULATION IN THE UNITED STATES [See Illustration in Original] It is interesting to note that in the United States, the long-term fall in overall death rates which characterized the first half of the twentieth century was interrupted in the decade of the 1950's by a flattening off.5 For males, the shape of the curve for mortality actually changed sign during the 1960's and passed from negative through zero to positive. The "excess" mortality (excess over what would have been expected from previously prevailing trends) was found to have been contributed principally by eight causal categories of which bronchopulmonary diseases accounted for over 50 per cent. Figure 3 illustrates the major causes of death which were responsible for "excess" mortality in 1967 compared with 1960. The apparent influence of environmental factors (in a broad sense) on these extra deaths — notably cigarette smoking along with other forms of air pollution and alcohol — is very prominent. n5,6 In summary, with the passage of time, social habits and environmental influences (in a broad sense) have become increasingly prominent as contributors to human mortality and morbidity.
Attempts over the past few years to search for associations between the health of members of the general community and characteristics of the environment have begun to provide some interesting insights. A recent study of the relationship between cancer rates for various residential locations and industrial activity offers sufficiently strong signals to indicate that the subject to worthy of further serious investigation.7 Finally, a striking group of observations of the past few years implicating environmental factors in the causation of disease has come from a series of migratory studies.8 In these studies, persons who migrate from [5 ELR 50181] one area of the world to take up residence in another appear to adopt the patterns of incidence of disease (notably chronic degenerative diseases) and causes of mortality of their new hosts in place of those characteristic of their former residence. Again, the implication that it is "something" in the environment which had led to the observed altered disease and mortality patterns is a very strong one indeed.
We [scientists] owe someone an apology. How is it we could arrive at this point with so little understanding?9 What Characterizes Present Knowledge for Environmental Health Decision-Making? It seems useful to review some of the important characteristics which mark this area of science and scientific investigation. Several environmental standards have been based on relatively little scientific information. Of the automobile emissions singled out for a mandated standard in 1970 was the family of nitrogen oxides. The basis for the particular numerical standard chosen by the Senate Committee on Public Works was ultimately to be found in a single set of epidemiological observations made as part of a pilot or preliminary study on school children in Chattanooga, Tennessee.10 It has become evident since the emission standard was established in 1970 that such a rough and preliminary piece of work was not adequate as the basis of such an important decision. Further, some of the measurement techniques used in the experiment were ultimately called into question. In similar fashion, the government's decisions and actions concerning the herbicide, 2,4,5-T, were based in the first instance on a single, unconfirmed set of animal screening tests performed for the National Cancer Institute of NIH.11 The basis for the EPA decisions to reduce the level of tetraethyl lead in gasoline was based principally on an inference that airborne lead in particulate form in cities from authomotive emissions was large in quantity, would settle to the earth and would be ingested by urban-dwelling children who already had a high body burden of lead from other sources. The science of environmental health has at times been described as a frontier science. This title has been used to point up the frequency with which the results of preliminary scientific investigations have been taken directly from the laboratory and reflected in judgments and decisions regarding the environment. This process necessarily avoids (or evades) the avenues of interpretation of experimental results by the peers of the investigator, publication in scientific journals, confirmation through further experimentation and, therefore, the several means for maturation of investigative findings traditional to most of science. The consequences of preliminary, frontier, scientific evidence in decision making for environmental health may, in the long run, be very serious and may not necessarily guarantee betterment of health. A measurable amount of the scientific investigation in behalf of environmental health has been of a low order of sophistication. Some of this investigation has been characterized by the term "testing," implying a process of accumulating relatively gross observations reflective not of a particular hypothesis or matter of scientific insight but rather the assumption that the more data gathered the better.12 This phenomenon has come about in part because of certain government policies which have encouraged such investigations. They may be laid in part, also, to the fact that this area of science has not always engaged the best professional and scientific minds. Much of the scientific investigation for environmental health is performed only with great difficulty (still further limiting the number of willing and able investigators). Studies involving human subjects, for example, clearly essential for certain kinds of insight, are extraordinarily time consuming, are difficult [5 ELR 50182] logistically, and generally produce statistical associations rather than establish cause and effect relationships. Similarly, some investigations are aimed at an understanding of the low-dose end of dose-response relationships. These investigations, by definition, deal with low-probability events and therefore require very large experimental samples in order to assure statistical validity. Finally, some mention should be made of the difficulties in matching the products of scientific research to the public expectations and to the requirements reflected in various legal instruments. For example, the establishment of environmental standards implies in many cases the identification of effective thresholds of effects. Major problems arise when multiple biological effects occur, when several organ systems are involved, and when effective thresholds cannot be established (or, in fact, do not exist). Further, the establishment of relationships between hazardous exposures and human subjects implies detailed or, at least, statistical knowledge of biological variability and knowledge as to how that variability is altered by diseases to give a pattern of known susceptibilities. This complex question of identification of susceptible members of the population and appreciation of susceptibility in reasonably detailed biological terms is one to which some discussion has been devoted recently although large numbers of unanswered questions remain.13 Again, the degree of biological understanding presently available is far less than is implied by the present-day political and legal instruments.13 Science Versus Political Science: A Vicious Cycle Protection of human health has been the overriding (and in some cases exclusive) motivation for environmental and consumer-related activity by governments — including the federal government. One might have predicted that all parties to these questions would have been highly motivated to bring about well-informed decisions solidly based on scientific information. In fact, quite a different pattern has emerged. The political constituency interested and influential in regulation has not been interested in the quantity and quality of information for regulatory decisions, and, to some extent, actively discourages the development of a sound scientific basis. In practice, the political climate surrounding regulation has been favorable for the gathering of basic scientific understanding upon which judicious and meaningful decisions should be made. Regulation by the federal government as an instrument for the protection of human health against noxious environmental substances and adulterated foods has a relatively recent history in the United States. The Pure Food and Drug Act, passed in 1906, has been considered as the first comprehensive measure of control.A succession of statutory authorities evolved over the years which extended the breadth of regulation, sometimes times its strength, and often its details. Food quality, therapeutic drugs, cosmetics, meat inspection, household products, machines emitting ionizing and nonionizing radiation, have in succession all been added to this list. Successful legislative moves have characteristically been advanced immediately following a perceived crisis. The Food, Drug and Cosmetic Act of 1938 was passed following the elixir of sulfanilamide disaster of that year.14 The next increment of this sort was the 1962 drug amendments following on the heels of the Thalidomide tragedy.15 The environmental legislation of the past few years concerning water quality, pesticides, automobile and industrial emissions into the atmosphere, etc., has almost all been based, according to both its language and its legislative history, on considerations of human health. Essentially, the promise offered by regulation has been that of prevention of disease that would accrue from exposure to noxious and harmful substances. The overriding issue in 1970 in the development of the Clean Air Act amendments was, by design, protection of human health. This was explicit in the legislative history of the Act,16 has been the consistent theme in all the public statements about the Act, and continues to be the exclusive aim of the framers of this legislation.17 In parallel with this succession of regulatory legislation has occurred another trend which is usually thought of as complementary to the first. This has been the separation of the government's protection or regulatory activities from its promotion activities. Successively, the nation through its Congress has demanded that an institutional distinction be made between those agencies of the government responsible for encouraging productivity in agriculture or favoring the development of new drugs and those responsible for protection from these products and their by-products. Thus, the Food and Drug Administration, which began its life as a part of the Department of Agriculture, was separated from it and made a part of the Federal Security Agency in 1940, and of the Department of Health, Education and Welfare in 1953. In 1970, the federal government established the Environmental Protection Agency — a new amalgam of bureaus and departments from several federal agencies, including Interior, Agriculture, HEW and the AEC. Some of these agencies had traditionally been charged with the development or promotion of a variety of desired elements of national life, such as recreational parks, electric power from nuclear fuel, or an assured [5 ELR 50183] supply of food at reasonable cost. Again, the intent in the case of EPA's formation was clearly to bring about a separation between agencies and institutions which aimed at development and promotion and those which were responsible for human protection from the undesirable or unexpected by-products of these developments. The rationale behind this insistence on division between protection and promotion is fairly straightforward and well recognized. Basically, there has existed the feeling that the conflict of interest was too strong and that protection through regulation could not be carried out under the shadow of a primary mandate to develop and promote. Many have therefore argued that regulation would inevitably be compromised if left in the hands of agencies such as the Department of Agriculture or the Department of Interior. The presidential statements accompanying the Reorganization Plan submitted to Congress proposing the establishment of EPA listed, among the advantages of the new agency, the fact that it would "… insulate pollution abatement standard-setting from the promotional interests of other departments."18 The parallel and related proposals for consumer product legislation have touched more or less strongly on this aspect of independence of regulatory authority. One of the major legislative proposals during the 1972 session of Congress, the Consumer Safety Act of 1972, would have removed the Food and Drug Administration from its present parent, the Department of Health, Education, and Welfare, and made it the nucleus of a new, independent regulatory activity. Here again the proponents for this legislative move argued that a Food and Drug Consumer Product Agency, administratively singled out and given independent status, would better serve the public's interest than would a Food and Drug Administration which was obliged to compete for attention and funds with other parts of HEW. The President's National Commission on Product Safety in 1970 concluded: Statutory regulatory programs buried in agencies with broad and diverse missions have, with few exceptions, rarely fulfilled their missions…. The reasons for their weaknesses include lack of adequate funding and staffing because of competition with other deserving programs within an agency…. Identification of the regulator with the regulated must be avoided if federal consumer safety programs are to succeed.19 It is, perhaps, to the meaning of the word "succeed" that attention should be given. If success is measured simply as the degree and aggressiveness of regulation, the admonition is undeniably correct.If, however, success is described in terms of the judiciousness of decision making in the public interest, of the quality of information and the breadth of issues considered in decision making or of the degree to which health is protected, the hypothesis which claims net public benefit of the separation of regulation from promotion perhaps deserves a further examination. Having acknowledged the established trend, it is important to consider some of the results (and especially the by-products) of rendering protective and regulatory functions independent of promotion. A major and commonly overlooked result of this separation is a corresponding division in the public constituency interested in and concerned with regulatory affairs. In brief, the active support of a regulatory agency, such as the Food and Drug Administration, tends to be as narrow as is its focus and to include only those strongly interested in regulation and protection. This institutional separation of regulation from promotion seems, in fact, to lead to the promotion of regulation to the virtual exclusion of all else. From the point of view of preserving the purity of the regulatory affair, this tendency toward bureaucratic isolation has been fairly successful. On the other hand, since the actively interested and supporting constituency for the FDA and the EPA is a narrow one, certain desirable elements (such as the doing of science for meaningful decisions) are not supported and tend to be forgotten. As a result of the narrowing of the regulatory agency's constituency (and, hence, of the agency's own interests and goals) there arises an interesting if unfavorable vicious cycle whose net result, in the case of regulation for health, seems to be to diminish the prospects of serving the best public interest, including the improvement of health. For example, there is little constituent interest or support for the quality of the scientific fabric behind standards and regulatory decisions. As there is little constituent support, there is little congressional support, and in turn, little support within the regulatory agencies themselves. Where logic would lead one to believe that the supply of good information on risks and benefits was vital to good regulatory decisions, in fact, there has been remarkably little support for the research necessary to back good decision making with adequate information of suitable scientific quality. Decision makers are left frighteningly empty-handed more often than may be realized. There is little incentive for good science for regulation and there are, as well, some frank disincentives. One of the strong underlying currents within the consumer movement in the United States during the past few years has been that it is "… time to stop studying and to start regulating." Some view science as inhibitory to desirable regulation rather than supportive and contributory. Representative Fountain has borne down more than once on the FDA — insisting that the Food and Drug regulator "… has preoccupied itself too much with science and insufficiently with regulation."20 During the floor debate on the 1973 appropriation bill for agriculture, environment, and consumer protection, Representative Delaney introduced an amendment to [5 ELR 50184] prohibit expenditurs for research on suspected carcinogens. He specifically opposed further government expenditures for scientific investigations to examine food and feed additives which were governed by the (prior) Delaney amendment. He urged that such scientific studies would be done only "… at the double expense of the consumer's pocketbook and his physical well-being." He contended that we would all fare better if studies ceased or were curtailed and the law enforced against dangerous cancer-causing substances.21
** Budget of the United States, Special Analysis, various years.
** Budget of the United States, Special Analysis, various years. There is an additional explanation for this lack of support for the government's acquisition of scientific information for regulatory decision making. Information is a strategic instrument. To some extent, he who controls the information for regulation controls the regulatory activity.Therefore, it is to the advantage of the parties most directly concerned with the character of regulation (both industry and the consumerists-environmentalists) to supply the information for its decisions rather than to encourage the government to develop its own resources. Thus, for example, the regulation of therapeutic drugs and food additives is performed essentially entirely on information supplied to the FDA by the producing industries. The budget record of investments in research and development by the regulatory agencies reflects this phenomenon. The Environmental Protection Agency, which was first brought into being in 1970, has enjoyed a steadily and rapidly mounting total budget for pollution abatement and environmental control activities. Between fiscal years 1970 and 1973 this agency's total budget increased from $1 billion to $7.4 billion (Figure 4). The majority of this money is dedicated to waste treatment plant construction for the control of water pollution as well as for assistance in the abatement of air and other pollutants. During this same period, the total research and development budget of that agency rose from $75 million to $177 million. The important fact to note is a very small and declining percentage of the total budget is spent in behalf of information (7.2 percent in 1970 versus 2.4 percent in 1973).
** Budget of the United States, various years. *** Budget of the United States, Special Analysis, various years. A marked contrast is seen in the case of the former Atomic Energy Commission (Figure 5). The total budget of this agency was of the same order as that of EPA ($2.6 billion in fiscal year 1973). The expenditure in behalf of research and development — especially that aimed at an understanding of the biological effects of radiation — was impressively large. Thus, of a total research and development budget of 50 to 60 percent of the total agency's budget, nearly 10 percent of that research and development effort was dedicated to biology and medicine. The interpretation which this author chooses to draw is that the Atomic Energy Commission (either with the acquiescence or encouragement of the Joint Committee on Atomic Energy) had seen that it was to its advantage to make investments in behalf of information as insurance for good regulatory decisions. Indeed, while the field of radiological health and safety is still filled with public controversy, there exists a better scientific understanding of the biological effects of radiation and the research work has been generally more sophisticated than for nearly all if not all other physical and chemical substances which are [5 ELR 50185] considered specific environmental hazards to man.22 To emphasize this point one more time, an accounting of all of the federal research monies spent in behalf of an understanding of the human health effects of environmental agents reveals that almost half has been dedicated to ionizing radiation. The Food and Drug Administration has fared better — especially in recent years (Figure 6). Since 1970, between a quarter and a third of its total budget has been dedicated to research. Former Commissioner Edwards' testimony to Mr. Fountain indicated, however, it has been because of that Agency's pressure and persuasion, not that of Congress. There is a curious circular chain of events in which this lack of suitable information for regulation is prominent. Isolated or semi-isolated regulatory agencies are not characteristically inclined to lend aggressive support to research and to the acquisition of scientific information. The administrators are sensitive to the views of their constituents, many of whom view this type of research as dilatory rather than contributory. At issue is the conflict between a short-term desire for protection and regulation and the length of time required for science to provide definitive results. An investment in chronic disease epidemiology (to ascertain the effects of DDT on human populations, for example) is an investment in future earnings where the period of the investment is thought of as too long to produce useful results. Since this translates directly into less financial grant and contract support for this area of research, university-based scientists are little inclined to prevail upon the EPA or the FDA as sources of funds for their studies. This is particularly unfortunate for at least two reasons. In the first place, this area of science is traditionally viewed as mundane and pedestrian and not of the sort which produces rewards in academic settings. Paradoxically, of course, is the fact that there is a true need for sophisticated insight into the disease processes thought to be caused by the very environmental agents under regulation. Secondly, and of immediate importance is the fact that the best of the scientific community is noticeably absent from much of the public discussion and interpretation of the scientific arguments used in particular regulatory discussions. A recent FDA Commissioner pointed to this lack of scientific support in a number of public utterances: We have had very little support and understanding from the medical and scientific community…. The very strange fact is, however, that when we need support for reasonableness before our congressional and other critics there is a deafening silence from our friends — both in and out of Government — case in point DES. Gentlemen, we can't have it both ways — either support our efforts to bring better science and perhaps more reasonableness into our regulatory efforts or accept more strictly defined regulations.23 Consequences of an Inadequate Knowledge Base The first and foremost consequence of an inadequate fund of scientific information concerning environmental health is missed opportunities for prevention of ill health. This, of course, is a serious consequence since protection of human health is the rationale for environmental control and regulation. Thus, exposures to methyl mercury might have been avoided if the process of microbiological methylation of mercury had been recognized and if the unusual biological properties of alkyl mercury had been appreciated. Similarly, several years' exposures of occupational groups to radon-filled atmospheres in uranium mines and to coal dust in coal mines occurred before the biological implications of these exposures were appreciated. Again, the automobile emission standards were designed in 1970 to treat only three substances thought to be of consequence to human health — nitrogen oxides, hydrocarbons and carbon monoxide. Within three years it became apparent (although not entirely clear) that additional substances, such as sulfates, may pose at least as serious a burden to health. A second consequence is that of inappropriate decisions which are occasionally offered in the place of incomplete information. This is often an unfortunate consequence regardless of how well-intentioned the decisions may have been. Environmental decisions characteristically imply large expenditures of money and have far-reaching impacts (as, of course, they are designed to do). Because they provoke large rearrangements in our lives, however, they require and deserve the best possible foundation of information. The petroleum industry, for example, has claimed that requirements to remodel refineries in order to produce lead-free gasoline or to remove sulfur from gasoline would place a severe strain on the construction industry in the United States. There have emerged, also, some paradoxical results of well-meaning decision making done in behalf of health. In some cases, for example, a regulation or judgment has only succeeded in trading one hazard for another. For many years, the federal government encouraged a view which condemned phosphate substances (known as builders) in detergents as contributory to accelerated eutrophication of streams and rivers in the United States. While the federal government exercised no regulatory action in this case, its point of view did encourage the development of a number of chemical substitutes for phosphate compounds in household detergents.One of the unforeseen results has been in an entirely unrelated area — the flameproofing of children's clothing. Regulations and standards for flameproofing had been prompted by public demand and these had been developed through the efforts of a different part of [5 ELR 50186] the federal establishment. What emerged was the fact that the flameproofing treatments on fabrics were compromised and rendered useless if the fabrics were washed in soap or, in fact, in any non-phosphate detergent. A second and better known example of a hazard exchanged for another hazard through regulation occurred with the banning of DDT and its replacement by organophosphate insecticides. These latter, while not possessing the high physical and chemical stability of DDT in the environment, are much more toxic acutely and, therefore, have posed severe occupational problems. A third and current example is that of the automobile emissions standards. The accomodation to the congressionally mandated standards would require the use of a series of anti-emission controls and devices on automobiles — the principal one of which is a catalytic converter. What became apparent only later was the high probability that catalytic converters would accelerate the conversion of sulfur contaminants in gasoline to sulfates leading to a new and less than healthful automotive emission.24 In addition to inappropriate decisions, a further consequence of a paucity of information for regulation is a peculiar rigidity in the regulatory process. This is, interestingly, a political response to inadequate information. In the face of a lack of scientific information, Congress and the regulatory agencies generally have tended in recent years strongly toward conservatism (i.e., protection of human health). This can be seen in tighter environmental standards, more conservative interpretation of the laws, and most important, a trend toward standards mandated directly by Congress. The most far-reaching and most controversial feature of the amendments to the Clean Air Act of 1970 was the set of quantitative limitations for automotive emissions.The Administrator of EPA enjoys essentially no discretion in this case but rather is obliged simply to enforce the imposed numerical standards. The other outstanding example of a statutorily mandated standard is the Delaney amendment to the Food, Drug, and Cosmetic Act mentioned above which relates to suspected carcinogens in food additives. In this case, of course, the mandated level is zero. These are clearly examples of a Congress' retrieving the regulatory decision process from the Executive Branch by relieving the agency of its descretionary powers. James Q. Wilson commented that the power of an agency is diminished the greater the degree there is of codification of its policies and rules. Power, he asserts, depends on uncertainty.25 Thus, this pattern would seem to be an example of bad public policy in the first instance. It also runs counter to science. Codification brings with it rigidity of regulation which conflicts directly with the dynamic character of science. By definition, science is a dynamic affair — continually raising new questions and new concepts and often overturning old ones.26 Finally, an additional undesirable consequence of rigid and mandated standards is that they tend to limit or discourage further research which is often needed to gain real understanding of the character and seriousness of an implied hazard. Once the preliminary observation was made of bladder tumors in laboratory animals and this was associated with the experimental feeding of cyclamates, there was little incentive to proceed further to understand the meaning of those observations. One should refer again here to Representative Delaney's conviction, cited at the beginning of this article, that investments in further research aimed at insight into suspected food additive carcinogens was to be discouraged. This vicious cycle is completed, when, as a result of little support for science leading to the serial consequences of inadequate scientific information and scientifically inappropriate decisions, there follows a further falling away of support by the scientific community. That his phenomenon has been increasingly characteristic of EPA there can be little doubt. Beleaguered as that agency has become because of the very nature of its mission, it has in addition been a party to a continually increasing falling away of support by the academic community — not only because of a paucity of monetary investment in research by that agency but additionally because of a number of questionably based decisions. A consequence of the narrowed constituency of regulation separated from promotion is lack of support for balanced decisions. From the point of view of the public's interest, this consequence is probably the most important one. Balancing, in this case, refers to an explicit and systematic consideration of a broad portfolio of matters which are inevitably related to a proposed regulatory action. Regulation to protect human health alone to the explicit exclusion of economics and of technological capability (which is the congressional mandate of the Clean Air Act) is antithetical to the achievement of balanced decisions. Yet, appropriate balancing in decision making is clearly in the nation's best interest. It was the perceived importance of this issue which led a recently concluded study of a Panel on Chemicals and Health of the President's Science Advisory Committee to place this subject of balanced decisions at the beginning of its set of conclusions and recommendations: "The single most important principle of this report is simple to state, but not easy to implement. Indeed, [5 ELR 50187] though it may sound obvious, we have found it frequently and conspicuously lacking in many administrative actions…. Regulatory procedures should ensure balanced consideration and balanced decision in regulatory action. This implies consideration of both direct and indirect consequences that will flow from eachof the possible actions."27 (Italics in the original.) This admonition by the President's Science Advisory Committee in favor of balanced decisions betrays the fact that, in general, these decisions have not been balanced. Again, balancing necessarily depends upon a suitable fund of information in every instance. The task of gaining new knowledge for this area of public decisions is an enormous one to the extent that it has appeared overwhelming to some who are charged with establishing its priorities. Yet, however acutely that message is felt within the scientific community, it is not well appreciated by others. There is need for biological insight across a broad front for environmental substances. At least as important, however, is a strong need for an increase in the level of sophistication of the research performed. Much decision making reflects the results of gross "testing" — the fulfillment of "standard" or "established" procedures. By contrast, there is an impelling need to insert a new but clearly attainable degree of sophistication into the research performed for the environment and health. Investigations should reflect specific hypotheses and scientific insight and should aim at uncovering an understanding of biological mechanisms of environmentally-related diseases. If the hypothesis outlined at the beginning is correct, that the narrow focus of the health-related regulatory actions (exacerbated by the enforced separation of protection from promotion) is inevitably antithetical to the appropriate investments in research and information-gathering and, in turn, to valid and balanced decisions in the public's best interest, then any solution must contemplate some element of compensation for this narrowness. An obvious option would be to replace the regulatory and protective functions within the walls of the promotional agencies and to undo a major trend of the past several years. The traditional argument in favor of separation is the perception that government regulatory activities become "captured" by the institutions which they are supposed to regulate. J. Q. Wilson has urged that this traditional viewpoint be re-examined suggesting instead that "… whether a [regulatory] Commission does or does not serve the ends of industry is much less important than whether it serves the correct ends…."28 While the assertion contains the elements of theoretical validity, it is also true that the public interest has often not been well served when regulation was heavily influenced by the industries regulated. However, the trading of one narrowness of decision making for another does not appear to serve the public's interest to any greater degree. In a way regulatory activities have to some extent been "captured" —if not by industry, then by a different but vitally interested constituency — well-meaning and dedicated but, at times, questionably informed. It may be inappropriate to think of a regulatory agency, separated out of other parts of administrative government, as independent. In fact, in some important aspects, it may become wholly dependent or responsive to certain elements or institutions of public and private life and, thereby, skewed in its views. The case does not seem to be one favoring reamalgamation of protection and promotion in single agencies. There is a case, however, for support — both from within and without the government — for broadly-based and balanced decisions and for sound information of high quality for decision makers. In brief, there must be created an effective constituency in support of the information fabric for decisions.Some imaginative thinking should be given to new mechanisms for the regulatory agencies and their administrators which would compensate for the narrowness of focus imposed by the political climate of regulation. Experiences in some other industrialized nations in this regard may be useful. It is clearly in the public's and, hence, the Congress' best interest to assure that health-related regulatory decisions are well informed. Otherwise, one can only expect a continuing series of frustrations on the part both of Congress and the Executive Branch punctuated by reversals of decisions and by occasional attempts to "lift" the decision process out of the hands of the agency responsible. 1. Ethyl Corporation v. Environmental Protection Agency, 5 ELR 20096 (D.C. Cir. Jan. 28, 1975), vacated, petition for rehearing en banc granted, 5 ELR 20450 (D.C. Cir. Mar. 17, 1975). 2. Environmental Protection Agency, Press Release and Report of the Decision of the Administrator Concerning the Suspension of the 1977 Motor Vehicle Exhaust Emission Standards, March 5, 1975. 3. Dept. of Health, Education, and Welfare, Cancer Rates and Risks, Public Health Service Publication No. 1148 (1964). 4. Dept. of Health, Education, and Welfare, Man's Health and the Environment. Some Research Needs (1970). 5. Dept. of Health, Education, and Welfare, Leading Components of Upturn in Mortality for Man, United States 1952-1967, National Center for Health Statistics, Publication No. (HSM), 72-1008, Series 20, Number 11, 1971. 6. Chemicals and Health, A Report of the Panel on Chemicals and Health of the President's Science Advisory Committee, Science and Technology Policy Office, National Science Foundation, September 1973. 7. R. Hoover & J. F. Fraumini, Cancer Mortality in U.S. Counties With Chemical Industries, Environmental Research (in press). 8. W. Haenszel, Migrant Studies: Contributions to Cancer Control and Epidemiologic Research, National Cancer Institute, National Institutes of Health (1974). 9. N. Nelson, Summary Remarks, Academy Forum on the Health Effects of Air Pollutants, National Academy of Sciences, Washington, D.C., October 1973. 10. Environmental Protection Agency, Air Quality Criteria for Nitrogen Oxides (1971). 11. J. R. M. Innes, B. M. Ulland, M. G. Valerio, L. Petrucelli, L. Fishbein, E. R. Hart, A. J. Pallotta, R. R. Bates, H. L. Falk, J. J. Gast, M. Klein, I. Mitchell, & J. J. Peters, 42 National Cancer Institute 1101 (1969). 12. L. Goldberg, Safety of Environmental Chemicals, The Need and the Challenge, presented before the Panel on Chemicals and Health of the President's Science Advisory Committee, Washington, D.C., February 7, 1971. 13. J. Finklea, Conceptual Basis for Establishing Standards, remarks presented to the Academy Forum on the Health Effects of Air Pollutants, National Academy of Sciences. Washington, D.C. October 1973. 14. J. H. Young, The 1938 Food, Drug and Cosmetic Act, in The Government and the Consumer: Evolution of Food and Drug Laws, 13 J. Public Law 197-204 (1964). 15. W. F. Janssen, FDA Since 1938: The Major Trends and Developments, 13 J. Public Law 205-221 (1964). 16. S. Rep. No. 91-1116, 91st Cong., 2nd Sess. 1 (1970). 17. A Congressional Perspective on the Role of the Scientific Community in the Development of Environmental Policy, remarks by Senator Edmund S. Muskie, Conference on Health Effects of Air Pollutants, National Academy of Sciences, October 3, 1973. 18. The White House, Fact Sheet on Reorganization Plan Nos. 3 and 4, July 9, 1970. 19. National Commission on Product Safety, Final Report, June 1970. 20. Regulatory Policies of the Food and Drug Administration, Subcommittee on Intergovernmental Relations of the Committee on Government Operations, June 9, 1970. 21. 119 Cong. Rec. H4811 (daily ed. June 15, 1973). 22. It will be interesting to test his interpretation over the next few years since the regulatory and the developmental portions of the AEC have now been institutionally separated and reside in the Nuclear Regulatory Commission and the Energy Research and Development Agency, respectively. 23. C.C. Edwards, FDA and the Medical Community, speech presented at the Institute of Medicine, Washington, D.C., November 17, 1971. 24. A Review of the Health Effects of Sulfur Oxides, submitted by Dr. David P. Rall, Director, National Institute of Environmental Health Sciences, National Institutes of Health, October 9, 1973. 25. J. Q. Wilson, The Dead Hand of Regulation, 25 Public Interest 39-58 (1971). 26. It is, in fact, the aspect of old decisions (especially for regulated products) perturbed by new scientific insight which has been at the heart of nearly all of the regulatory crises of the past three to five years. 27. Chemicals and Health, supra, n. 6. 28. Wilson, supra n. 25. 5 ELR 50179 | Environmental Law Reporter | copyright © 1975 | All rights reserved |