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1 Summary and 1 Major Recommendations INTRODUCTION This report is an outgrowth of the work of the NRc'S Committee on Environmental Decision Making (CEDM). The first recommendation in that Committee's report reads as follows (NRC 1977c: 10~: EPA'S decisions on standards and regulations should be supported by analyses that explicitly state the objectives of the decisions, identify feasible alternatives, evaluate (quantitatively, to the extent possible) the consequences of each alternative decision, explore potential problems In implementation, and indicate and examine the degree of uncertainty about the effects of EPA actions. He analyses should be available to the public. The authors of that recommendation knew they were setting forth an ideal that many branches of EPA were already striving to attain, and that there was much doubt within EPA that it was feasible to come noticeably closer to attaining that ideal than already was the case, in view of the limited resources and information available to the Agency. The CEDM, however, did not share those doubts. On the contrary, it felt that by intelligent use of the available information and resources EPA could implement the recommendations far more consistently than it had been doing. The CEDM made extensive suggestions to this eject (NRC 1977c:25-36~. With this background, EPA entered into a contract in late 1977 under which the National Academy of Sciences would study the feasibility of 1

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2 REGULATING PESTICIDES implementing routinely the quoted recommendation. This was to be accomplished by the most practical test of actually undertaking to assess the risks and benefits of three pesticides. The Committee on Prototype Explicit Analyses for Pesticides (PEAP), appointed to undertake these three assessments, soon requested that its charge be revised to provide for a closer direct involvement with EPA'S Office of Pesticide Programs (oPP). The new~charge to the PEAP Committee was to observe oPP's assessment of three pesticides and to provide advice and consultation directly to oPP on how to make its analytical assessment methodology more explicit. The methodological recommendations developed from this experience would be written up as the Committee's report and illustrated, to the extent that oPP's three assessments did not follow the recommendations, using the three pesticides oPP was assessing. The focus of the Committee's study was to be oPP's mechanism for conducting benefit-risk analyses, the Rebuttable Presumption Against Registration (RPAR) process. Shortly after beginning to work with oPP, the Committee recognized the overwhelming problem that confronted oPP and its attendant delays. Chapter 3 describes how oPP is charged with issuing literally thousands of legally defensible regulations each year concerning the use of pesticides in U.S. agriculture and elsewhere. The critical need that preoccupies oPP is for procedures and methods that will enable it to process as rapidly as possible the thousands of decisions it is required to make. As soon as PEAP became aware of this urgent need, it tried to meet it. This report is the Committee's attempt. The Committee has not ignored its charge to develop and implement more explicit analytical methods for risk and benefit assessments, but it has embedded that charge in the larger and more immediate problem. In order to expedite its work, the Committee has concentrated on a single pesticide, chlorobenzilate, instead of three. Chapter 2 reviews the legislative and legal status of the Federal Insecticide, Fungicide, and Rodenticide Act of 1947 (FIFING) as amended, which is the legal foundation of oPP's activities. The chapter also describes the administrative procedures that oPP has devised to carry out its responsibilities under the Act. The subsequent chapters discuss in more detail the procedures used by oPP, together with recommended changes the Committee believes will enable oPP to perform analyses in accordance with the recommendation of the CEDM and to do so expeditiously and within the severe constraints of resources and information available to oPP. Chapter 3 deals with a problem of broad strategy: the determination

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Summary and Major Recommendations 3 of the order in which pesticides are to be considered for further analyses and possible regulation. As the Committee sees it, the judicious ordering of tasks is the key to the fulfillment of oPP's responsibilities. Chapters 4 and 5 deal with a pair of parallel tasks that have to be performed for each pesticide considered. Chapter 4 is concerned with assessing the risks to public health and to the environment that result from the use of a pesticide and with the erects of alternative regulations on those risks. Chapter 5 deals with the parallel assessment of the social and economic benefits of the use of a pesticide and, again, of the changes in those benefits that result from various regulatory alternatives. Chapter 6 seeks to bring those two assessments together. This is, perhaps, the most difficult part of the task and the part where careful scientific stab work is of least avail. The risks of pesticide use include increases in mortality and morbidity and impairment of environmental vitality and amenities of all kinds. The benefits are largely, but not entirely, an increase in the availability of foods and natural fibers and a reduction in the amounts of resources needed to produce them. It is the responsibility of EPA'S Administrator to select the regulatory alternatives for each pesticide that, in his or her judgment, permit the freest possible use of the pesticide that does not impose additional risks that are excessive in relation to the additional benefits they afford. No one can relieve the Administrator of this responsibility. The benefits, for the most part, are the monetary equivalent of economic resources; the risks concern depends partly on the Administrator's personal scale of values and partly on his or her perception of the values held by the society in whose behalf he or she acts. That is to say, it is partly a moral and partly a political judgment. In these circumstances the most that staff and consultants can do is prepare for the Administrator their best reasoned judgment of the material consequences, in terms of all likely benefits and risks, that are apt to follow from any of the alternatives. The difficulties are magnified by the circumstance that no one knows, or should pretend to know, precisely what risks and benefits will flow from any of the alternatives. The stab has to present to the Administra- tor its reasoned judgment of the limits within which the risks and benefits of the various alternatives are likely to lie. Frequently these will be very broad limits, in spite of the best efforts of the stab to narrow them. The Administrator's task is then more difficult, but it would be misleading for the stab to convey an impression of more certainty than its knowledge affords. The final chapter, Chapter 7, is a sample application of the methods recommended by the Committee in the chapters that precede it. Although the entire study was conducted within the context of oPP, the Committee did not lose sight of its broader objective: to study

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4 REGULATING PESTICIDES empirically the feasibility of implementing CEDM'S recommendation that the benefits and costs of environmental regulations be assessed by explicit and quantitative (insofar as possible) evaluation. The Committee concluded that a policy of maximum explicitness and quantification would facilitate the work of oPP by enforcing systematization and standardization and by increasing the clarity of communication among the various specialists and levels of authority involved. The Committee believes that this conclusion, as well as many of the detailed recommen- dations listed below, is applicable with equal force to other branches of EPA, and it hopes that its recommendations win be accepted in that lift. In one important respect, however, the Committee found that oPP was already carrying quantification to an unwarranted extreme. In many of its evaluations oPP attempts to estimate the effects of various potential regulations on human morbidity and mortality. As set forth in detail in Chapter 4, this effort generally places more weight on our understanding of the pathological effects of pesticides than it will bear. It should be stated before setting forth our recommendations that this Committee, like oPP' labored under severe constraints of resources, time, and talent. There are many issues we have not been able to pursue or to probe as deeply as we should have. We are painfully aware of many deficiencies and gaps in the report. For example, the Committee did not have the time to consider the question of getting much more reliable data (as would be highly desirable) or other questions such as the consider- ation of biological alternatives to pesticide control. Further discussion of how the scope of this report was limited appears at the end of this chapter. Like oPP, we have done the best we could with the limited resources available. SUMMARY AND MAJOR RECOMMENDATIONS Principal recommendations are summarized and discussed briefly below. CHAPTER 3 With responsibility for regulating some 35,000 pesticides and an analytic staff that, though large in absolute terms, is a small fraction of what is required for the task, oPP is in urgent need of a plan of operation that will direct its attention at the earliest possible time to the pesticides whose uses present the gravest threats to public health and the environment. This plan should be adapted to the fragmentary informa- tion now available, should not impose additional burdens on the already overburdened staff, should provide for acquiring all the information that

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Summary and Major Recommendations s is likely to be available in time to be used in reaching the decisions that require it, and should be flexible enough to be amended as new data emerge. The Comm~ttee's recommendations, outlined below, are de- signed to meet these criteria. The recommendations are closely allied to the concept of generic chemical reviews (U.S. EPA 1978), and like that concept take advantage of the fact that the enormous variety of pesticide formulations makes use of a much smaller number- approximately 500 of active ingredients. The Comm~ttee's first recommendation concerns the all-important matter of deciding on the order in which pesticides should be considered for possible RPAR proceedings. We recommend the following procedure: oPP should review the 500-odd active ingredients used in registered pesticides and identify the ones that appear to be significantly toxic and in widespread use, on the basis of readily available information. Priorities should be assigned to these active ingredients, determined by relative toxicity and extent of use, and oPP should consider registered pesticides for Span proceedings in the order of the priorities that have been assigned to their ~ Cal J ~ active ingredients. Pesticide formulations that have the same active ingredients (or ingredients of equal toxicity) should be considered for REAR in an order that rejects the extent to which each formulation is used. The review and preliminary ordering of the SOO-odd active ingredients could be done by a committee of consultants. This recommendation is discussed in more detail and suggestions for implementing it are made in Chapter 3. In one important respect, however, it will frequently be necessary to diverge from the priority order established by the procedure recommend- ed above. Particularly during the early stages of the process, some of the information needed to evaluate regulatory alternatives will not be at hand when needed by the RPAR assessment team unless special efforts are made to obtain it. The data in question relate to the public health, environmental, and economic ejects of the alternative pesticides that will be brought into use by a regulation that restricts the use of a pesticide high on the priority list. When the alternatives to a pesticide for a particular use are significantly toxic and have not yet been evaluated, assessment of potential regulation requires that their effects be known, in order to estimate the changes in risks and benefits that would result from adopting the regulation. The following recommendation is intended to assure that this information will be at hand at the time that the regulator decision has to be made. At an early stage of the work of reviewing a pesticide for possible regulation, the pesticides that are alternatives to it in its major uses should be identified. If any of them are presumed a potential toxic hazard and have not

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6 REGULATING PESTICIDES yet already been reviewed, they should be promoted from their assigned places in the queue and reviewed as promptly as possible. One consequence of this recommendation will be that the several pesticides that are alternatives for the same use will be reviewed simultaneously. This will make it possible, and advisable, to issue or deny reregistrations for that use for that group of pesticides, without waiting for decisions on the other uses of many of those formulations. The application of this recommendation also is discussed in detail in Chapter 3. CHAPTER 4 The use of a pesticide may entail manifold risks. Risks to public health are currently EPA'S predominant concern. These include the risks of inducing cancers, mutations, spontaneous abortions, or abnormal offspring. A wide variety of other chronic and acute toxic effects may also be induced. In addition to impairing public health, a pesticide may have adverse ejects on nontarget animals and plants, including crops, livestock, and important wild species. Since the purpose of any regulation is to reduce some or all of these risks, estimates have to be made of the severity of the risks under the regulatory options that are considered. Since risks to public health are currently EPA'S primary focus, the Committee concentrated its attention on them, and among these risks paid particular attention to assessing the risks of inducing cancers. It should be pointed out, however, that long-term effects of pesticides on the environment per se and eventual indirect ejects on humans may, in the long run, be more important than evaluations of risks and benefits based solely on toxicity to animal or human. This report admittedly does not address this important topic. The Committee scrutinized carefully the methods used by oPP and EPA'S Carcinogen Assessment Group. As a result of this scrutiny it came to the conclusion, very much in line with the position of the Director of the NC! (Carter 1979), that our present understanding of the mechanisms of cancer.development does not permit us to draw reliable numerical inferences from the kind of laboratory data normally available about the ejects of pesticides and other compounds on the development of cancers in humans. The bases for this conclusion are already well known and are set forth at some length in Chapter 4 and Appendix A. On the basis of this conclusion and the fact that, once outside CAG, numerical estimates of human cancer incidences are often misued in EPA'S decision making, the Committee makes the following recommendation:

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Summary and Major Recommendations 7 oPP should abandon its attempts to produce numerical estimates of the elects of the use of pesticides on human mortality and morbidity except when reliable human epidemiological data are available. In the usual case, in which major reliance has to be placed on the results of bioassays, those results should be used to construct indicators of the relative pathological activity of the pesticide under review in comparison with other pesticides and compounds. The elect on public health of alternative regulations should be presented in the form of estimates of the doses of that pesticide to which pertinent segments of the population will be exposed under those regulations. The doses received should be evaluated according to the pesticide's virulence relative to other pesticides and compounds. The Committee recognizes that this recommendation is inconsistent with the practice and methodological recommendations of some previ- OUS NRC reports that have, in fact, recommended and used extrapolation techniques to derive numerical estimates of human cancer incidence from animal data (NRC 1972; 1976; 1977a, b, d; 1978a, by. But, for the reasons discussed in this report, the Committee feels that the change suggested here will improve the decision-making process. The situation with respect to other aspects of public health appears much the same. Empirical data on the mutagenic, teratogenic, and toxic ejects of pesticides on human populations are rarely available, and the basis for inferring those effects from laboratory experiments with animals is generally lacking. Consequently, for those hazards also, to the extent that they have to be inferred from laboratory experiments with animals, the Committee recommends that the laboratory data be used to show how the pathological activity of the pesticide under review compares with the activities of other pesticides and compounds in producing ejects. The effect on public health can be indicated by estimating the doses to which pertinent segments of the population would be exposed under alternative regulations, taking relative patholog- ical activity into account. An important component of assessing the effects on public health of using a pesticide is-the task of estimating the number of people who would be exposed to it and the doses that major segments of the population would be likely to receive. Empirical data are often deficient or entirely lacking, so that estimates must be inferred from fragmentary sources or by analogy with other pesticides or experiences. Making these inferences requires close familiarity with the conditions under which the pesticide is used and with its routes of transmission, a familiarity that the oPP stab cannot be expected to have in all instances. In order to enhance the quality and reliability of these estimates the Committee makes the following recommendation:

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8 REGULATING PESTICIDES It should be a routine practice for the members of the EPA staid team reviewing a pesticide to visit sites where it is applied, facilities where it is formulated and handled, and laboratories where it is studied, and on those visits to hold informal discussions with the people in day-to-day contact with the manufacture, handling, and use of the pesticide. The risks attendant on the use of a pesticide, as well as the economic benefits that it produces, depend on the length of time it is used. Expenence indicates that the economic lives of most pesticides are limited, both because target species frequently adapt to them and because they are often superseded by improved compounds. Unfortu- nately there is very little information about the economic lives of pesticides or about the factors that influence them. Accordingly the Committee recommends that: OPP should undertake or sponsor a study of the economic lives of pesticides and the factors that inJquence the economic lifetimes. Estimates of both lifetime exposures and economic benef is should be based on the periods of use that are revealed to be reasonable by this study. This discussion and the Comm~ttee's investigation generally have revealed that every component of the appraisal of risks is subject to substantial uncertainty. oPP' however, almost always presents its exposure estimates as single figures without an accompanying indication of the degree of uncertainty. Every reader of the estimates, undoubtedly, is aware that the estimates are subject to error, but normally readers have no grounds for judging how large the errors are likely to be. It is important that this information be provided. The format preferred by the Committee is to present two estimates of every component of risk and the data used in deriving those estimates. One of these figures should convey the analyst's best judgment of the level that actually would be realized under the assumed conditions. The other figure should present an estimate of the maximum risk likely to be experienced (barring an extremely implausible chain of unfavorable circumstances). These two estimates are referred to in the text as the "most-probable" and "maximum-plausible" estimates of risk. In the Committee's own work the most-probable estimates correspond generally to the mode in statistical terminology, and the max~mum-plausible estimates to the upper limit of a 90 percent confidence interval. These considerations lead to the following recommendation: The methods now used by oPp for estimating the exposures associated with various regulatory options are sensible and, with the modifications discussed above, are as sound and reliable as the available data permit. The resultant estimates, however, are subject to substantial ranges of uncertainty that should always be kept in mind. To this end, estimates that are subject to

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Summary and Major Recommendations 9 uncertainty should always be presented as a pair of numbers, one showing the exposure or other aspects of risk deemed most probable, and the other showing the maximum exposure or comportment of risk likely to be experienced (in the absence of an implausible array of untoward circum- stances). These conclusions, particularly the rec~i~hat unless there are adequate epidemiologic n~ical estimate should be made of the eject of various regulatory options on human morbidity and mortality, have profound implications for the assessment of regulatory alternatives. They imply, in particular, that regulatory decisions have to be made on the basis of data that do not show explicitly the effect of alternative regulations on the attainment of the purposes being pursued. Put differently, it would be far easier to choose among regulations about which the ejects on mortality rates or on the rate of incidences of cancers are known than among regulations about which the only available information concerning risks is the estimated doses of chemicals having roughly estimated pathological activities to which populations will be exposed. Yet these are the only data that can be provided to the regulatory authorities in most instances. Chapter 6 discusses at some length the problem of reaching regulatory decisions under these circumstances. CHAPTER 5 Pesticides confer many kinds of benefits. They are an essential ingredient of modern commercial agriculture and forestry. They contribute to public health by controlling insect vectors of disease. They protect ornamental trees, lawns, and shrubs. They reduce the numbers of insects in residences and other structures. Since, however, the Committee's resources were limited and according to the 1978 estimates (U.S. EPA 1979) about three fourths of all pesticides by volume are used in agriculture, the Committee devoted its review of benefit estimation entirely to agricultural use. In the course of its review, the Committee studied numerous directives and memoranda that prescribe the methods used for benefit evaluation in oPP and evaluated in detail the benefit analyses of six pesticides. oPP's analyses of the benefits of pesticide use in agriculture are all based on a procedure called "partial farm budgeting." This procedure amounts to estimating the ejects of alternative regulations of the use of a pesticide on the net farm incomes of growers of the crop that the pesticide is used to protect. It therefore implicitly defines the economic eject of regulating a pesticide to be its eject on net farm income. But

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10 REGULATING PESTICIDES this can be misleading. If a regulation increases the cost of producing a certain crop, the total output of that crop will be reduced and its price will generally rise. This rise in price will offset the increase in farm production costs and the decrease in farm revenues caused by the reduction in the size of the crop. The offset can be substantial; in fact, in several of the analyses the Committee studied, it was so great that net farm income was increased as a result of restrictions on the use of a pesticide. But of course national income is not increased. The rise in price that cushions the ejects on the incomes of farmers is borne by the consumer, and in a more complete accounting of the effects of the regulation, the loss on the part of consumers would offset completely the cushioning effect of the price rise on the incomes of farmers. The Committee therefore recommends: ~ In applying the partial farm budgeting approach to estimating the benefits of pesticide use, oPP should exclude the effects on net farm income of changes in crop prices induced by the regulations. A budgeting procedure that implements this recommendation is described in Chapter 5. The estimates obtained by following the corrected farm budgeting approach will be tolerable approximations to the effects of regulations on national income, but they will not reveal the differential ejects on farmers, on consumers, and on other population groups whose welfare may be of interest. Those differential effects are often significant. oPP should therefore continue to use its present methods for estimating ejects on farm income and should supplement those estimates with estimates of the effects of regulations on the incomes of other population groups. A format for incorporating all these consequences of regulation is also suggested in Chapter 5. One of the serious problems inherent in estimating the economic ejects of regulating pesticides is the difficulty of foreseeing how farmers will respond to regulations, in particular of foreseeing what alternative methods of pest control they will employ. The analytical methods currently used by oPP do not allow for farmers' responses to the differing costs of various methods of pest control nor do they take into account the extent of farmers' experience with different methods. It appears that the mechanical method currently used has a tendency to overstate the loss in benefits that would result from restricting the use of pesticides. Though any forecast of changes in pesticide control methods must be conjectural, the Committee recommends that a more realistic and less biased method be used; one such method is suggested in Chapter 5. In making forecasts it is essential to assemble and evaluate all possible information. The site visits recommended in Chapter 4 Drill be useful for this purpose.

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Summary and Major Recommendations 11 Under the best of circumstances the estimation of the economic effects of regulating a pesticide is a difficult task. It must employ data from many sources, often unpublished and sometimes very informal. It requires the exercise of considerable judgment in choosing underlying assumptions and in making approximations where data are deficient. For these reasons the resultant estimates require very careful review with respect both to the quality and reliability of the data employed and to the appropriateness and adequacy of the methods used. The current procedures in oPP provide for a highly qualified review of risk assessments (by the Science Advisory Panel) but not for a comparable review of benefit assessments. The Committee therefore places particular emphasis on the following recommendation: oPP should establish an external Benefits Review Panel, similar in organization to the Scientific Advisory Panel, consisting of entomologists, plant pathologists, weed specialists, economists, and others with expertise in assessing the benefits of pesticide use. This panel should have the responsibility of providing external scientific reviews of the benefits data and analyses. For each RPAR compound, a review team (consisting, for example, of one entomologist and one economist) should be selected from the panel. This team, in contrast to current sAP procedures, should be involvedfrom the earliest stages of the benefits assessment, and should have the primary responsibility for presenting an evaluation of the benefits assessment to the entire Benefits Review Panel. CHAPTER 6 Chapter 6 deals with the assimilation of the results of the risk and benefit analyses discussed in the preceding two chapters. It considers two principal topics: the generation of alternative regulatory options and the comparison of the ejects of the alternative options studied. Actually, the generation of the regulatory options cannot wait until the late stages of the study. At least a general preview of the possibilities that eventually will be evaluated is needed from the very inception of the analytic work in order to initiate the accumulation of relevant data and to establish the assumptions to be used in preparing the estimates of risks and benefits. Additional regulatory possibilities are likely to emerge, however, as the work progresses. The plans for analysis should be revised as such new possibilities come to light, so that the data necessary for appraising them will be available when needed. The options available for regulating a pesticide are generally fairly well standardized. An agricultural pesticide being reviewed for reregis

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12 REGULATING PESTICIDES tration will normally be used on several crops (food and fiber production accounts for almost 75 percent of pesticide use by volume), in several sections of the country, and for contending with a number of different pests. The regulatory options, then, are choices among which of these uses (if any) are to be allowed and disallowed. Restrictions may also be placed on the mode of application of the pesticide in any or all of the uses and on precautions that may be required to reduce the exposures of people and of nontarget species in general. Considerable familiarity with the pesticide and its use, as well as some exercise of ingenuity, is required to select ~ manageably small number of significant regulatory alterna- tives that have good promise of reducing undesirable exposures without imposing prohibitive or excessive costs on the users. It is generally not feasible to analyze more than a half dozen or so alternative options with any thoroughness. The development of alternative options is therefore an important matter, and deserving of considerable deliberation and attention, because it delimits the range of choice. The eventual decision will be a choice of the best of the regulatory alternatives subjected to analysis; regulatory possibilities that may be substantially superior are forever ruled out if they are not included in the list of options subjected to analysis. Thus, the development of the list of regulatory alternatives amounts to a rejection of all possibilities not included in the list and as such is a genuine regulatory decision. It should not be regarded as merely a preliminary stage in the analysis. The second stage in the decision process is the adoption of one of the options that have been proposed and analyzed. The data pertinent to this choice are the costs of the different options (discussed in Chapter 5 as forgone benefits) and their erect on risks of various sorts (discussed in Chapter 4), all of which are imperfectly known. Furthermore, these costs and risks have to be known or estimated in some detail, since different segments of the population will fare differently under the different options. It cannot be expected that there will be any option that is superior to all the rest from all points of view or from the standpoint of all members of the population. Thus the choice inevitably amounts to choosing among risks of various sorts, between risks and economic costs, and among options that are favorable to different segments of the population. These choices are difficult and cannot be made mechanical- ly. Choices of this sort are the subject of decision theory, which by now has developed a substantial body of techniques for facilitating decisions. Most of the techniques used in decision theory depend upon the decision maker's "utility function," which is essentially a scale for measuring the _. . ~.. . . ~.

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Summary and Major Recommendations 13 relative desirability in his or her esteem of different combinations of costs, risks, and other consequences that may be expected to result from the selection of any one of the options. In the Committee's judgment these utility functions cannot be ascertained in the circumstances in which oPP operates. We therefore recommend procedures that do not employ this concept, but rather consist of presenting in intelligible form a menu or range of choices open to the decision maker. The recommend- ed procedures are discussed in some detail in Chapter 6. CHAPTER 7 The Committee's work had both a normative and a descriptive aspect. The normative aspect was to make recommendations that would facilitate the analytic and decision-making work of oPP and would increase the cogency of their analyses. The descriptive or empirical aspect was to test the feasibility of those recommendations in the light of the limitations of data, time, and facilities that constrain oPP in reaching its numerous decisions. In the nature of the case, we were not able to formulate a test with any pretensions to scientific rigor. Our test consisted of working through a single decision problem- the choice among alternatives for regulating the pesticide chlorobenzilate using only data and methods that are available to oPP. We were not able to do even this task completely realistically, because our stab and other resources were far smaller than those that oPP can bring to bear on a similar problem and because we were restricted to using, with some minor exceptions, only the data that oPP had generated in its analysis of chlorobenzilate-although our recommendations called for acquiring certain additional data at an early stage in the study of a pesticide. Chapter 7 reports the results of this test application of our recom- mended procedures. We studied five regulatory options and obtained clear indications of their relative merits and demerits. We deliberately refrained from choosing among those options, since the limitations under which we worked made it presumptuous for us to over such a decision, and since it was not part of our purpose or charge to second-guess oPP's choice. Nevertheless, this small test persuades us that it is entirely practicable for oPP to carry out analyses in accordance with the procedures that we recommend. It is for the reader to judge whether the information yielded by our recommended procedures is significantly more helpful in arriving at decisions than the information provided by oPP's current methods. The Committee thinks that it is.

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14 CONCLUDING REMARKS REGULATING PESTICIDES The Committee's thinking evolved strikingly in the course of its work. In the beginning, it perceived its task as testing the feasibility of employing the established methods of benefit-risk analysis in decision-making procedures of EPA, using the Office of Pesticide Programs as a test case. Almost immediately it became embroiled in the overwhelming problems that oPP confronts: the problem of processing the reregistrations of some 35,000 pesticides within the tight timetable prescribed by the legislation. The Committee became increasingly impressed by the enormousness of the task assigned to oPP. On the one hand, it was obvious that simple expeditious procedures were required for processing the individual pesticides. On the other hand, it was just as obvious that rough and ready methods would not suffice. The implications of the decisions for public health and environmental integrity were too great, and the stakes that many people had in them were too high for decisions to be reached lightly or without thorough analysis of their implications for consumers, for farmers, for farm workers, and for everyone concerned with health and with environmental conditions. The recommendations summarized above show that the Committee did not choose to sit on either horn of this dilemma. Life for oPP cannot be made simple, and the Committee quickly abandoned the attempt to make it so. Most of the recommendations are directed to increasing the logical and scientific probity of oPP's analyses. The Committee believes that by following standardized procedures of greater logical clarity, oPP can save some time and effort in the performance of its tasks, but not very much. More time can be saved, and electiveness can be increased, by following a more systematic strategy for selecting pesticides for review, as recommended in Chapter 3. These improvements can alleviate oPP's predicament somewhat, but they can by no means enable oPP to complete its assigned task within the time allotted. The Committee cannot claim to be offering oPP a solution to its central problem, that of arriving at considered judgments about the regulation of all the pesticides used in this country in a short space of time. So much for the quantity of decisions. Quality is also important, and here the Committee feels more content with its work. The Committee was impressed by the carefulness and thoughtfulness of oPP's work, but it did observe a number of significant shortcomings. These have already been summarized and there is no need to repeat them. Still it is worth repeating that many of the deficiencies result from inadequacy of the data available to oPP. Insufficiency of data is a frustrating and time consuming obstacle to every phase of the analyses. Appraisals of risk to

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Summary and Major Recommendations 15 human health are made complicated and uncertain by the lack of information about human exposures. Estimates of the costs of restrictive regulations are made vague and controversial by the paucity of information about the electiveness of pesticides. There is little reliable information about the elects of most pesticides on nontarget species of animals or vegetation, wild or domestic. As exemplified in Chapter 7, mucn or tne analytic effort of oPP Is devoted to attempting to bridge these gaps in the data by interpolating, extrapolating, or inferring from whatever tangentially relevant information can be found. Research designed to remedy these deficiencies would expedite and strengthen oPP's analyses greatly. Of course, much such research is in progress; it should be pursued vigorously. More complete and systematic monitoring of exposures of people and wildlife to pesticides and the ~nn~.~ll~nr are of particular importance. L . 1~ ~ _ ~ the . ~ . . . . . . ., , ~ ~ _,__-, The recommendations in Chapter 4 concerning the characterization of the pathological potencies of different pesticides point to an area of special concern. This report has already raised strong objections to the methods currently in use. The proposed alternative, Carcinogenic Activity Indicators, have more scientific justification, but they, too, rest on assumptions that stand in need of verification. The CAN'S also are somewhat difficult to interpret, though this difficulty may stem largely from their unfamiliarity. Although the Committee recommends that CA'S be employed as indicators of the relative hazardousness of different chemicals, it does not feel that the measure recommended is the ultimate word. Serious research should be undertaken into methods for measuring and expressing the potencies of different chemicals in inducing, ~.~nrPr~ and other diseases. _ ~ This report has commented several times on the vast scope of oPP's task. The Committee's task was correspondingly large, so that we were forced to concentrate on a few salient aspects of the work to the neglect of many other important issues. For example, our review of the analysis of the cost of pesticide regulation was confined to the costs of regulating pesticide use in commercial agriculture. Other uses, for the control of disease vectors, for noncommercial gardening, and many other purposes are by no means negligible, and in fact account for over a third of total pesticide use. Though the Committee could not review the costs of regulating any application of pesticides other than in commercial agriculture, those costs are undoubtedly substantial and the methods used to estimate them should be audited carefully by some specialists who are independent of EPA. The Committee's review of the estimation of the risks of using pesticides was similarly incomplete. It was limited almost entirely to the

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16 REGULATING PESTICIDES estimation of risks to public health, and within that area to the risks of increasing the incidence of cancer and adverse mutations. The Commit- tee feels that most of the risks to public health that result from prolonged exposures to pesticides give rise to issues similar to the ones studied and should be dealt with by similar methods. The estimation of the risks of acute toxic ejects is an entirely different, but apparently less difficult, task. The Committee did not consider it. Neither was it able to consider the appraisal of the environmental and ecological consequences of pesticide use beyond noticing that the data available for making such estimates are particularly inadequate and untrustworthy. No attention could be paid to the possibility of long-run climatolog~cal, ecological, or evolutionary effects. In short, there are wide gaps in this study, long though it is, gaps that may be serious and which ought to be filled. Finally, while enumerating the inadequacies that the Committee is painfully aware of, the length of the report has to be included. The report is far too long, but to quote Sam Johnson, "there was no time to make it shorter." REFERENCES Carter, L.J. (1979) How to assess cancer risks. Science 204:811-815. National Research Council (1972) The Effects on Population of Exposure to Low Levels of Ionizing Radiation. Assembly of Life Sciences. 1974-582412:45. Washington, D.C.: U.S. Government Printing Office. National Research Council (1976) Health Effects of Alpha-Emitting Particles (Hot Particles) in the Respiratory Tract. Assembly of Life Sciences. BPA 520/4-7~013. Washington, D.C.: U.S. Environmental Protection Agency. National Research Council (1977a) A Review of the Use of Ionizing Radiation for the Treatment of Benign Diseases. Assembly of Life Sciences. U.S. DHEW (PDA) 78-8043. Washington, D.C.: U.S. Department of Health, Education and Welfare. National Research Council (1977b) Considerations of Health Benefit-Cost Analysis for Activities Involving Ionizing Radiation Exposure and Alternatives. Assembly of Life Sciences. BPA 520/4 77-003. Washington, D.C.: U.S. Environmental Protection Agency. National Research Council (1977c) Decision Making in the Environmental Protection Agency. Volume II, Analytical Studies for the U.S. Environmental Protection Agency. Committee on Environmental Decision Making, Environmental Studies Board, Com- mission on Natural Resources. Washington, D.C.: National Academy of Sciences. National Research Council (1977d) Drinking Water and Health. Assembly of Life Sciences. Washington, D.C.: National Academy of Sciences. National Research Council (1978a) Nitrates: An Environmental Assessment. Environmen- tal Studies Board, Commission on Natural Resources. Washington, D.C.: National Academy of Sciences. National Research Council (1978b) Chloroform, Carbon Tetrachloride, and Over Halomethanes: An Environmental Assessment. Environmental Studies Board, Commis- sion on Natural Resources. Washington, D.C.: National Academy of Sciences.

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Summary and Major Recommendations U.S. Environmental Protection Agency (1978) Notice of Intent to Establish a Generic Standards System for the Registration of Pesticide Products; Solicitation of Public Views. Proposed Federal Register Document, Office of Pesticide Programs, Washington, D.C. U.S. Environmental Protection Agency (1979) Pesticide Industry Sales and Usage 1979 Market Estimates. Office of Pesticide Programs, EPA, Washington, D.C. 20460. (Unpublished) 17