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FIFRA and the REAR Process LEGISLATIVE FRAMEWORK INTRODUCTION The stakes are high in pesticide regulation. The increased yield and subsequent economic return to U.S. agriculture from pesticide technolo- gy and the return to the chemical industry have encouraged many to rely on pesticides as a primary means of pest control. Farmers spend more than $2.2 billion a year on chemical pest control, thereby increasing the value of their output by an estimated $8.7 billion, that is, by about 9 percent (Pimentel et al. 1978~. However, the possibility of substantial risks to human health and to ecosystems from wide-scale use and, sometimes, misuse of chemicals may entail costs beyond those that society is willing to accept. On the other hand, depriving agriculture of an important tool for which there is no substitute may involve risks and economic costs both to the industry and to society that are - also unacceptable. Pesticides, depending upon the dose or exposure level, may produce acute or chronic toxic effects in nontarget organisms, including humans. There is increasing evidence that some chemical pesticides pose long- term cancer and other risks to humans exposed to them through dermal contact, inhalation, or the food chain. Society thus must decide how much, what kinds, and what uses of chemical pesticides to allow. In recent years, the historical presumption that unrestrained technolo- gy is beneficial (the protechnical attitude) has been questioned. Evidence 18

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FIFRA and the RPAR Process 19 is accumulating, largely from the sciences of public health, ecology, and economics, that technologies may have hidden impacts that produce unacceptable side ejects. Consequently, society has increasingly come to accept the proposition that technologies that affect the environment should be rigorously assessed before they are applied. The case for evaluating technologies by some form of benefit-cost analysis (the analytical attitude) is a strong one, in the abstract. In practice, however, because of the great uncertainties involved in pesticide assessment, rigorous benefit-cost analysis is almost impossible. The most rational comparison of the benefits of using a pesticide with the risks it entails is fraught with uncertainty. Beyond that, stating the question as one of comparing risks against benefits runs the danger of weighting the answer on the side of risks, for there is a general reluctance to balance risks to human health against mere economic gains. Calabresi and Bobbitt (1978) in their book, Tragic Choices, explain why society is reluctant to attempt rational trade-o~s: When tragic choices are made through the pure market within an ex~st~g distribution of wealth, costs arise which are external to the immediate decision makers and are borne instead by the rest of us. These external costs may limit our willingness to permit a market: The social costs of Indentured labor, for example, surely include one's outrage at inducing the poor to sell themselves, and this cost must be considered before the society allows peonage. The willingness of a poor man, confronting a tragic situation, to choose money rather than the tragically scarce resource always represents an oblique indictment of society's distribution of wealth. That willingness, when it follows a first-order determination which has been made collectively, is a yet more insistent accusation; it presents the wrenching spectacle of a rich man and a poor man bidding against each other for it. Yet the degree of redistribution of wealth necessary to avoid such external costs would itself be too costly. It might require a virtual equivalence of wealth such that incentives to produce would not survive. The tragedy of the choice is the basis for adoption of a conservative attitude that urges society to avoid the risks of introducing untried technologies. The conservative attitude has both a substantive and a procedural dimension. Substantively, it asserts categorically that it is wrong to subject persons to certain risks. Procedurally, it places the burden of proof on advocates of technological innovation and requires that change be held in abeyance pending the production of information necessary to a rational assessment of the innovation's net value to society. Distinctions among the protechnical, analytical, and conservative attitudes as discussed above are essential to understanding the role of the legal system in setting rules for pesticide regulation. But it must be

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20 REGULATING PESTICIDES realized that the political process is too dynamic and flexible to fix consistently on one attitude to the exclusion of others. Because the stakes are high in pesticide regulation, the decision-making process can accommodate diverse interests only through compromise. For this reason, laws regulating the entry of pesticides into the market and their subsequent use reflect simultaneously all three of the above attitudes. The task of implementing the compromise legislation is then delegated to an administrative agency EPA. The legislation tells the Agency that pesticides are to be assessed rationally, that some risk is acceptable, but that in any given case the Agency may be conservative in deciding to prefer risk avoidance over economic benefits: in short, that EPA has great but not unlimited discretion to regulate pesticides. Knowledge of the background and structure of the laws regulating pesticides is essential to understanding the problem with which this report is concerned: How can EPA improve its procedures for rational evaluation and regulation of pesticides? The problem is at one level a technical one; at another level it is a question of consensus about issues. But the consensus does not exist. EARLY LEGISLATION: CONSUMER PROTECTION Pesticide regulation developed in an atmosphere that presumed that the application of technology was beneficial. Subsequent legislation has challenged, but not supplanted, the earlier legislation based on this assumption, although the first two statutes regulating pesticide manufac- ture and use were classic examples of consumer protection legislation. Chemical pesticides came into widespread use toward the end of the nineteenth century. The formulas were simple and the compounds were sold by many small, often itinerant dealers, or mixed by farmers themselves with products ordered by mail. The fragmented market made it easy to pass on adulterated goods, and this state of affairs alarmed Congress in 1910. In response to pressure from the U.S. Department of Agriculture (USDA) and farm organizations, a simple statute was passed in 1910 specifying the percentage of certain ingredients for Paris green and lead arsenate (arsenical pesticides) and setting general standards for other insecticides or fungicides. Enforcement was ad hoc, as the evidence necessary to prove a violation of the statute was collected only by random plant inspections or through user complaints. The Insecticide Act of 1910, therefore, had a limited purpose-the protection of consumers from fraudulent goods-but the purpose was seen as an adequate response to the problem until 1947. Pesticide compounds ceased to be simple by the end of World War II

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FIFRA and the RPAR Process 21 as synthetic organic pesticides came into widespread domestic use. The new chemicals were more toxic, and valuable nontarget species were vulnerable to damage if the pesticide was not used with care. Congress, therefore, felt that there was a need to provide users with the advance information necessary to make informed choices. The Federal Insecti- cide, Fungicide, and Rodenticide Act of 1947 (FIFED) required for the first time that all pesticides be registered before they could be marketed and that the label specify the content. This law is an extension of classic consumer protection objectives. A rational user is assumed and the problem is defined as the disclosure of sufficient information for the user to make an informed choice. The crucial assumption underlying FIFRA was that the major problem associated with the use of pesticides was their efficacy. The major basis for denying registration was that the label contained claims that differed from those made to the USDA. The only protection against undesirable erects of the pesticide on nontarget species and plants was afforded by the requirement that the label identify the pesticide as a poison. The USDA administered FIFED on the assumption that efficacy was the major problem and, as a consequence, the bulk of the USDA'S regulatory activity was concerned with ensuring that pesticides were labeled accurately. Few chemicals were barred from the market. SHIFT TO HEALTH AND ENVIRONMENTAL PROTECTION The assumption that efficacy was the principal problem was challenged in the 1960s, first by Rachel Carson's Silent Spring (1962) and then by a series of presidential commissions. These challenges led to the current laws. The basic argument raised by critics of pesticide use is that the major problem is safety, not efficacy: pesticides are potentially unsafe because they have unanticipated erects on nontarget species, and thereby pose risks to ecosystem stability and to human health. The problem can be solved only partially by the disclosure of impact information. A full solution requires that some pesticides be barred from the market or have limits placed on the circumstances in which they can be used. Theoretically, this solution was possible under FIFRA because the statute had established three review points for a pesticide: (1) registration, where the chemical was screened prior to market entry; (2) suspension, a quasi- summary removal from the market; and (3) cancellation of a registra- tion, which resulted in permanent removal from the market. However, as administered by the USDA, there was no substantial safety review at any of these three stages. In part, the lack of adequate safety review was

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22 REGULATING PESTICIDES caused by 1947 legislation that allowed a registrant whose chemical was challenged to obtain a protest registration, thereby shifting the burden of proving a pesticide ineffective or unsafe to the government and allowing the challenged chemical on the market. In the 1960s, a two-pronged attack was made against USDA'S interpretation of FIFRA and on the adequacy of the legislation itself. Fit was attacked by both the courts and Congress. Each branch of government produced a reform of pesticide law, but the reforms were not identical. The divergence between the approaches of the Congress and the courts accounts for the tension in EPA'S current regulatory policy and the continuing controversy that surrounds the scope of pesticide regulation. The courts adopted a conservative strategy by giving the USDA and, subsequently, EPA the discretion to ban pesticides on the basis of a comparison of benefits and risks that took a very conservative view of socially acceptable risk. Congress accepted the necessity of basing decisions upon risk as opposed to proof of harm, but attempted to ensure that risk would be only one of the relevant factors considered by EPA. To this end, Congress imposed a process that based all decisions on a balanced benefit-cost analysis derived from neoclassical welfare econom- ics. These two strains of reform the courts' and Congress's form the basis of EPA'S current regulatory policy. An appreciation of the related but distinct nature of each is essential to understanding the problems that EPA iS now facing in subjecting pesticides to a rational benefit-risk analysis. The Role of Congress Congress reformed FIFRA in two stages. In 1964, protest registrations were eliminated and the definition of a misbranded pesticide was expanded to include pesticides that would injure invertebrate animals, as well as vertebrates and plants valuable to man. The 1964 amendments expressly directed the USDA'S attention to safety considerations for the first time. Eight years later, FIFRA was supplemented by the Federal Environmental Pesticide Control Act of 1972 (FEPCA). FEPCA did not eliminate the consumer protection objectives of the earlier statute, but supplemented them with the recognition that the public generally needed to be protected from potentially harmful erects of pesticide use. The heart of EPA'S expanded mandate is Section 3(c)~5), which requires the Agency to refuse to register a pesticide unless it is determined that "when used in accordance with widespread and commonly accepted practice it will not cause unreasonable adverse

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FIERY and the RPAR Process 23 ejects on the environment." The phrase "unreasonable adverse ejects on the environment" is defined in Section 2(bb) as "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide" (emphasis added). The standard, "unreasonable adverse ejects on the environ- ment," controls the Agency's determinations about the acceptability of a proposed use of a pesticide. A reading of the legislative history supports the Agency's position that FIFE, as amended by FEPCA, requires the Agency to subject all pesticide uses to benefit-cost (or benefit-risk) analysis. The legislative history is equally clear that in all stages of decision making the analysis should be a balanced one, that is, that equal weight be given to benefits and risks. Congress recognized that some risks are inherent and unavoidable in pesticide decision making, but wanted risks to be weighed against benefits in every decision. Some environmentalists have questioned this reading of the legislative history. They argue, on the basis of drafts and explanations by the environmen- tally oriented Senate Commerce Committee, that a substantial showing of benefits would be required if a finding of risk were made. However, a close reading of the legislative history indicates that the analysis was to be a balanced one. The "spirit" of the section was summed up by the report of the House Committee on Agriculture, whose version became the final bill: "As the committee labored through the months of hearings and discussions, one central legislative philosophy developed . . . the theme of the 'search of balance!"' (U.S. Congress, House 1971:5~. Any doubts that Congress intended a balanced assessment of benefits and risks were dispelled in 1975 and 1978 amendments to the legislation. A constant theme in the 1975 hearings was that EPA was not giving adequate attention to agricultural development (i.e., benefits of pesticide use) in its decisions. Congress redressed the imbalance indirectly by strengthening the role of the USDA in the decision-making process and by creating a new Scientific Advisory Panel, composed of seven persons appointed from a list of six nominated by the National Institutes of Health and six nominated by the National Science Foundation. The 1975 amendments have been described as a shotgun wedding between EPA and the USDA. Specifically, FEPCA was amended to require the Administrator of EPA to take into account the ejects of cancellation and suspension of a pesticide's use upon the production and prices of the relevant agricultural commodities when the Agency issues a notice of intent to cancel. Further, in connection with final action, the Administra- tor must prepare and publish an agricultural economic impact statement. To ensure that the Administrator receives the views of the agricultural community, proposed cancellation and suspension notices must be sent

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24 REGULATING PESTICIDES to the Secretary of Agriculture at least 60 days before they are issued, and if the Secretary comments in writing within 30 days, the comments must be published in the Federal Register. The Scientific Advisory Panel was created to review health and environmental hazard assessments with the intent to provide unbiased and objective opinion on the risk side. The thought was to put a check on EPA'S use of a line of reasoning that held that lack of knowledge about ejects is a valid basis for banning a chemical in order to err on the side of safety. Proposed cancellation and suspension notices are sent to the Scientific Advisory Panel, and the Panel's comments are published along with those of the Secretary of Agriculture. Upon a finding of imminent hazard to human health, however, the Administrator may waive the notice and comment procedure for a suspension proceeding. The conclusion that emerges from the legislative history is that Congress recognized that a certain level of risk is inevitable in pesticide use and that the presence of risk is not sufficient reason to deny or cancel the registration of a pesticide. The Role of the Courts At the same time, however, the courts were developing the doctrine that risk alone is sufficient grounds for denying or cancelling a registration. The doctrine evolved in a series of decisions reviewing USDA and, subsequently, EPA decisions to suspend and cancel registrations. What these decisions did was to set a conservative risk standard to determine what evidence would trigger a benefit-risk analysis and, then, to hold that the trigger evidence would be a sufficient basis to support a final conclusion that the risks exceeded the benefits. Only secondary attention was required for benefits. This is the assumption behind the Rebuttable Presumption Against Registration (RP~) process (described later in this chapter). RPAR rules stem much more from the pesticide precedents in the U.S. Court of Appeals for the District of Columbia Circuit than from Congress, as the 1978 amendments to FEPCA illustrate. The first issue the courts were required to decide was when the USDA had a duty to suspend a chemical and institute cancellation proceedings under FIFED. We issue arose in 1969, when the Environmental Defense Fund (EDF) petitioned the USDA to cancel all DDT registrations and the USDA refused. The 1964 legislation required the USDA to suspend a pesticide and institute cancellation proceedings if suspension were necessary to "prevent imminent hazard." In a major decision interpret- ing the phrase, the court transformed FIFING from a consumer protection to a regulatory statute by holding that once a substantial question of

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FIFRA and the RPAR Process 25 safety was raised, the burden of proof shifted to the manufacturer to justify continued registration (EDF V. Ruckelshaus 1971~. This burden has been described as "heavy" (EDF V. U.S. EPA 1971) in that it requires the registrant to establish the safety of a pesticide. Similarly, another court said that "once risk is shown, the responsibility to demonstrate that the benefits (of continued use) outweigh the risks is a heavy one . . . " (EDF V. U.S. EPA 1976~. A risk analysis often hinges on important but abstruse debates among scientists about the permissible inferences that can be drawn from laboratory expenments. In such situations, the most the courts can do is attempt to understand the issues, make sure that the Agency has considered all relevant factors and that all parties have had adequate and real participation in the decision process, insist that the Agency has disclosed the basis of its reasoning sufficiently to pendant a court to conclude that the decisionfollows from the evidence, and make sure that there is some objective basis for the decision. However, in the end' as long as EPA bases its cancellation or suspension decisions on a risk analysis that has respectable scientific support, its discretion is practical- ly unreviewable. In the heptachlor-chlordane suspension decision, the U.S. Court of Appeals for the District of Columbia Circuit announced the following standard: An ultimate finding in a suspension proceeding that continued use of challenged pesticides poses a "substantial likelihood of serious harm" must be supported by substantial, but not conclusive, evidence. In evaluating laboratory animal studies on heptachlor and chlordane there was sufficient "respectable scientific authori- ty" upon which the Administration could rely in detennining that heptachlor and chlordane were carcinogenic in laboratory animals. Human epidemiology studies so far attempted on chlordane and heptachlor gave no basis for concluding that the two pesticides are safe with respect to the issue of cancer. To conclude that they pose a carcinogenic risk to humans on the basis of such a finding of risk to laboratory animals, the Administrator must show a causal connection between the uses of the pesticides challenged and resultant exposure of humans to those pesticides. He made that link by showing that widespread residues of heptachlor and chlordane are present in the human diet and in human tissues. Their widespread occurrence in the environment and accumulation in the food chain is explained by their chemical properties of persistence, mobility and high solubility in lipids (the fats contained in all organic substances). Residues of chlordane and heptachlor remain in soils and in air and aquatic ecosystems for long periods of time. They are readily transported by means of vaporization, aerial drift, and run-off of eroding soil particles. The residues have been consistently found in meat, fish, poultry and dairy products monitored in the FDA Market Basket Survey and are also frequent in components of animal feeds. This evidence supports a finding that a major route of human exposure is ingestion of contaminated food-stu~s. EPA'S National Human

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26 REGULATING PESTICIDES Monitoring Survey data show that heptachlor epoxide and oxychlordane, the principal metabolites of heptachlor and chlordane respectively, are present in the adipose tissue of over 90% of the U.S. population. (EDF v. U.S. EPA 1976) The other side of a benefit-risk analysis is an evaluation of the benefits of a pesticide's use. Welfare economics has made some progress In developing benefit-cost (or risky procedures that can be applied to pesticide decisions. EPA has generally argued that its mission is to protect the public from environmental harm, and thus it is entitled to devote more attention to the risks of an activity than to its economic benefits. EPA'S general policy has never been directly challenged in the courts, but there are indications that the courts may define with some precision the duty to consider benefits as the choices the EPA must make become harder. When the court reviewed the aldr~n-dieldrin suspension hearing, it was the first time that the court considered EPA'S duty to assess benefits, and out of this case a rather casual attitude toward benefits developed: a suspension was analogized to a preliminary injunction (a decision before a court decides the merits). The duty to consider a suspension arises when any substantial question about a pesticide's safety is posed. When this occurs, EPA is obliged to suspend whenever there are no offsetting benefits to the public. Therefore, the Administrator has not exercised his or her discretion properly unless he or she has given adequate consideration to benefits. The court's standard makes it clear, however, that the court is interested primarily in a discussion of benefits that is basically adequate to support a suspension decision, but it does not expect a rigorous analysis: The Administrator's mere mention of these products' major uses, emphasized by the EPA, cannot suffice as a discussion of benefits, even though "the data before him . . . reflected the view that aldrin-dieldrin pesticides are the only control presently available for some twenty insects which attack corn and for one pest which poses a real danger to citrus orchards. . . . " (Brief for EPA: 19) The interests at stake here are too important to permit the decision to be sustained on the basis of speculative inference as to what the Administrator's findings and conclusions might have been regarding benefits. Sound principle sustains the practice of vesting choice of policy with the Administrator. Its corollary is that the specific decision must be explained, not merely explainable, in terms of the ingredients announced by the Administrator as compromising the Agency's policies and standards. This is the case even though the variables of the policy approach selected by the Administrator are not necessarily required by the underlying statute. Our conclusion that a mere recitation of a pesticide's uses does not suffice as an analysis of benefits is fortified where, as here, there was a submission, by EDF, that alternative pest control mechanisms are available for such use. The analysis

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FIFRA and the RPAR Process 27 of benefit requires some consideration of whether such proposed alternatives are available or feasible, or whether such availability is in doubt. (EDF V. U.S. EPA 1972) In subsequent cancellation and suspension cases, the adequacy of benefit analyses has been given secondary emphasis, although the duty to consider benefits is higher in the former than in the latter. This secondary emphasis is given because (1) the benefit claims have often been raised by manufacturers without adequate evidence, and (2) alternative chemicals have been available. For example, in the hepta- chlor-chlordane suspension hearing, the Administrator's benefit analysis of use on corn was sustained on this ground: Heptachlor and chlordane were used on an estimated 3.5% of the total corn acreage in the United States in 1975, largely in an effort to control black cutworm. Cutworms sporadically infest 2 to 8% of total U.S. corn farms, and occur most often in lowland, river bottom areas. Chlordane and heptachlor are used as preplan" treatments to insure against possible infestations. The Adminis- trator found, with record support, that no macro-economic impact will occur as a result of suspending those pesticides. He also found that crop surveillance or "scouting" for infestations during the early weeks of plant growth, together with application of post-emergence baits or sprays where necessary, provide an effective alternative to the more indiscriminate prophylactic use of chlordane and heptachlor. Velsicol urges that this approach is not as effective as the persistent protection provided by chlordane. Especially in the absence of proof of a serious threat to the nation's corn, there is no requirement that a pesticide can be suspended only if alternatives to its use are absolutely equivalent in electiveness. The Administrator reasonably took into account that a transition period would be necessary to implement post-emergent techniques of control and concluded that the challenged pesticides could continue in use for corn protection until August 1, 1976. This evaluation of alternatives and the time required to implement them is supported by substantial evidence, and we find no basis to disturb the Adm~n~strator's balancing of costs and benefits. (EDF V. U.S. EPA 1976) However, the attitude of giving secondary attention to benefits is changing for institutional and legal reasons. As pesticide issues become more difficult to resolve, and better benefit evidence is generated, the hard-look doctrine, which courts follow with respect to judicial review, may require EPA to present a more technically acceptable benefit component of the benefit-risk analysis. A benefit advisory panel to parallel the Scientific Advisory Panel might do much to strengthen EPA'S benefits presentation (see Chapter 51. A recent circuit court decision on an issue not involving pesticides illustrates the possible procedural impact of such a panel. Seacoast Anti

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28 REGULATING PESTICIDES Pollution League v. Costle (1978) held that the Administrator cannot use a technical panel's recommendation as the basis for his or her decision when the technical panel's assertions rest on scientific literature not introduced into evidence in the hearing. Seacoast held, in erect, that if an expert advisory panel is asked for a recommendation, the conclusions on which the recommendation is based must be documented with evidence consistent with the state of the art. Seacoast further suggested that the use of advisory panels will require the Administrator to weigh a panel recommendation carefully or run the risk that a decision will be remanded for failure to justify departures from the recommendations. Formally, of course, science advisory panels cannot bind the Adminis- trator, since the issues at stake in a pesticide regulatory decision are ones of policy. However, in subtle but significant ways, a technical panel shapes the issues and the weighing of the evidence. To summarize, from 1910 to the present, federal pesticide legislation has evolved from largely a registration to primarily a regulatory statute affording greater protection to both human health and the environment. The legislation of 1910 and 1947 was basically concerned with consumer protection. In the 1960s and early 1970s, the need was recognized to evaluate a pesticide's safety and to remove unsafe pesticides from the market. The 1972 legislation provided the framework for weighing the benefits of using a pesticide (theretofore unquestioned) against the risks it entails, and for cancelling unsafe pesticide uses. It required that all the pesticides then registered, some 35,000, be reviewed under the newly established standards of safety. In the mid-1970s judicial decisions seemed to weigh risks more heavily than benefits. As a result, in 1975 and 1978 additional legislation was enacted in an attempt to restore the balance between risk and benefit considerations. Recent court decisions appear to be moving in that direction. THE RPAR PROCESS: A DESCRIPTION The preceding discussion of the legislative framework describes the evolution of EPA'S current mandate to protect public health and the environment from "unreasonable adverse effects" of pesticide use. The mandate is interpreted to authorize an evaluation and weighing of costs (or risks) and benefits to be used in determining whether a pesticide should be registered, reregistered, or cancelled. The following discussion describes EPA'S current procedures (as of mid-1979) for implementing that mandate, namely, the Rebuttable Presumption Against Registration (RPAR) process. The RPAR process was adopted in late 1975, and it is a key part of EPA'S plan to review the approximately 35,000 pesticide

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FIFRA and the RPAR Process ~5 EPA erred in determining that the pesticide meets or exceeds the risk criteria in 40 CFR 162.11; (2) any risk that exists can be reduced to such an extent that significant adverse elects are unlikely to occur; or (3) benefits of using the pesticide exceed the anticipated risks. By the time 180 days have elapsed, EPA iS supposed to have determined whether all risks have been rebutted. A second Agency position document may be issued at this point presenting EPA'S analysis of the rebuttals. If the risks are rebutted, the RPAR iS cancelled, and PD 2 iS issued. More commonly, however, if all risks have not been rebutted, PD 2 and PD 3 are issued jointly in one document. PD 3 iS issued together with a notice of the proposed determination concluding the RPAR ("notice of intent") and presenting the benefit-risk analysis supporting the proposed action. The collection of benefit data, like risk data, begins well before PD 1 iS issued, even though the benefit assessment does not appear in a position document until PD 3. The benefit assessment procedure is a joint effort between USDA and EPA. Current USDA/EPA procedures provide for the establishment of a joint assessment team as soon as oPP announces an- intention to issue an RPAR. In practice, the procedure will usually allow teams to be formed approximately 60 90 days prior to issuance of the RPAR. The collection of benefit data is supposed to be completed within 180 days of issuance of the RPAR. An additional 60 days is then provided for completion of the analysis, although extension of this deadline is frequently necessary. The proposed determination and PD 3 (or PD 2/3) are issued upon completion of the independent risk and benefit assessments, supposedly 240 days after the initial RPAR notice. Sixty days before the Agency plans to issue a final determination, the proposed action and supporting position document (PD 3 or 2/3) are sent to the independent FIFED Scientific Advisory Panel (SAP) and the USDA for their review as required by the 1975 amendments to FIFING. Me scientific review given to the risk and benefit assessments is described later in this chapter.) If comments are received within 30 days, the comments and EPA'S response are published in the Federal Register with the proposed regulation. Thirty days after comments are received, EPA'S Administrator is supposed to issue the final determination, supported by PD 4. Of the above deadlines, only the rebuttal period and the final external (USDA and SAP) review period are Congressionally imposed, and even there, some flexibility is allowed. In 1977, EPA estimated 4 1/2 months (135 days) between rebuttals and PD 2/3, making the total time from PD 1 to PD 4 roughly 300 days (see Figure 2.3~. In fact, however, delays occur at each step of the process, extending the deadline indefinitely.

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36 THE ANALYSIS REGULATING PESTICIDES The preceding sections have described the framework into which the actual activity flows involved in conducting the risk and benefit evaluations fit. In practice, the purpose of the RPAR process is to provide a decision maker with information on the trade-o~s between risks and benefits associated with regulatory options for each RPAR pesticide. This section describes the sequence of steps and the organizational arrange- ments involved in the development of an RPAR decision document. Details of the methods used in the various analyses that ultimately constitute the risk and benefit assessments are described in Chapters 4 and 5, respectively. The major participants in an RPAR analysis are the project manager and the RPAR team. The project manager coordinates and synthesizes the benefit and risk assessment activities carried on by the members of the RPAR team. In accordance with the Administrator's Health Risk and Economic Impact Assessments of Suspected Carcinogens: Interim Proce- dures and Guidelines (U.S. EPA 1976), benefit and risk assessments are conducted separately. Thus, when the management, risk, and benefit components are considered together, a tripartite flow of activities results. The basic steps involved in these activity flows are presented in Figure 2.4 (see Figure 2.3 for the related time schedule). It should be emphasized that there is continuous communication and interaction among individuals from each activity stream. Organizational Arrangements Risk Assessment Lead organizational responsibility for conducting risk assessments in oPP lies with the Hazard Evaluation Division (HED), which is divided into four branches: Toxicology, Environmental Fate, Residue Chemistry, and Ecological Erects. Table 2.1 shows the major components of oPP's risk assessment and the lead organizational responsibilities. The HED iS responsible for analyzing human exposure and human health and ecological hazards associated with pesticide use. Throughout the RPAR process, technical competence is provided both by HED stab and outside consultants. While HED iS responsible for assessing acute and chronic hazards, investigation and analysis of cancer hazard is delegated to CAG, an agency-wide group that focuses on predicted human risks from exposure to suspected carcinogens. Cancer risk assessments made by CAG are submitted to HED for further review and evaluation. In cases where carcinogenicity is the only hazard, HED provides the exposure analysis

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FIFRA and the RPAR Process 37 and retains review and evaluation responsibilities for the risk assess- ments prepared by CAG. There is, however, a move within the Agency to centralize risk assessment, and changes in the organizational arrange- ments described above can be expected. A close, informal working relationship is maintained between HED and oPP's Benefit and Field Studies Division (BFSD). The primary aim of this interaction is to enhance HED'S understanding of basic pesticide formulation and to use concepts as they relate to areas of potential risk. The interaction also provides insight into the feasibility of various regulatory options being considered by HED. Such insight is important when the issue of enforceability of proposed regulatory options is taken into account. Benefit Assessment Lead organizational responsibility for conducting benefit analysis in oPP lies with BFSD, which is divided into three branches that are organized along disciplinary lines: Animal Science and Index, Plant Sciences, and Economic Analysis. Table 2.2 shows the major components of oPP's pesticide benefit analysis and the lead organizational responsibilities for analysis. The general guidelines for the joint EPA and USDA benefit assessment effort are presented in a 1976 "Memorandum of Understanding between the U.S. Department of Agriculture and the U.S. Environmental Protection Agency" and an October 1977 supplement to that memorandum. A key element of the guidelines is a provision for establishing a joint assessment team for gathering and analyzing benefits data. The assess- ment teams (officially referred to as the usDA/state/EPA Benefit Assessment Teams and hereafter abbreviated to USDA/EPA) consist of representatives from USDA, state departments of agriculture and agricul- tural colleges (extension service and experimental station personnel), and EPA. The USDA, state, and college representatives including the team leader are selected by the USDA (through the Pesticide Coordinator, Office of Environmental Quality Activities, USDA). The EPA personnel are appointed by the BFSD within oPP. The size of the team varies from about three to fifteen, depending upon the complexity of the assessment. An important function of the state and agricultural college people, who are usually biologists, is to develop the basic biological information (e.g., yield effects) and, to some extent, the economic data (e.g., price per pound of active ingredient) necessary for conducting a benefit analysis. In addition, the extension and experimental station experts frequently provide information (e.g., method of application) useful in exposure analyses. These data are gathered through a combination of literature searches and personal communications with various agricultural experts

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38 ~ Management \ Flow Risk Analysis Flow \ REGULATING PESTICIDES AWL Assemble Data Base (ex isti ng files, lit. search ) Select Studies V d for Risk - (Triggers) ~all ate Assessment Establish Use Determine / Profile _ Routes of Data Exposure l at' Form Risk Analysis Team Form Benefit _ Conditional _ Analysis _ Benefit _ Team ~ Review and Request Data Review Val idations, Guide Initial Analysis ~ _ Determine Uses to be _ Analyzed / / / _ Initial Statement / / a. _ Risk _ of Data ~/ Analysis Needs / Review and / Evaluate _ Statement / Assessment Needs Plan FIGURE 2.4 Tripartite activity flow (sequence of steps) in support of the RPAR process. Source: Keaney (1977). TABLE 2.1 Components of Pesticide Risk Assessment and Principal Organizational Responsibilities in the Office of Pesticide Programs Component Background Chemical and physical properties Environmental fate and persistence Human exposure analysis Dermal Respiratory Dietary (food and water) Inhalation, penetration and absorption rates Human health risk Cancer Acute toxicity Other chronic toxicity Ecological hazard a Not a branch of HED. HED Branch Residue Chemistry Environmental Fate Environmental Fate Environmental Fate Residue Chemistry Toxicology CAG,a Toxicology Toxicology Toxicology Ecological Effects

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FIFRA and the RPAR Process Draft Regulatory notions Distribute Statement of Data Needs Validate, Document and Modify Initial Risk Assessment Document \ Validate, Document and Modify Conditional Benefit Document _ _ Prepare Potential Adverse Effects Document for Chemical in RPAR Process _ _ Convey Document on Substitutes to Management Representative Risk Analysis Team etc. I Decisi on on Review Rebuttals Convey Relevant Triggers within Information to _ Previously Risk and Benefit Defined Structure Teams Prepare Conditional Risk Argument on Substitutes _ _ Consideration of Information Generated from Interaction with USDA, Regions, and States _ Review Scientific and Analytic Progress. Final Statement of Regulatory Options. Fine Tune Analytical Process Where Appropriate. Conditional Risk Expanded to Include Secondary Risk from S',hstit''t~c Develop Arguments or Calculus of Benefits by Option 39 . ~ Consolidation of Risks and Benefits Attendant to Regulatory Options. 77 If/ l (reviewed in Chapter 5~. Finally, it appears commonplace for some of the agricultural college (or perhaps USDA) people to have a background in toxicology or allied fields, thereby allowing the joint assessment team to comment on EPA'S risk assessment. The economic impact assessment is usually a joint effort by economists from both USDA (Economics, Statistics, and Cooperatives Service) and EPA (Economic Analysis Branch, BFSD, OPP). Before the official report of the assessment team is forwarded to oPP, it must be approved by a variety of USDA officials, including the Secretary of Agriculture. However, the terms of the Memorandum of Understand- ing allow each agency to reach independent assessments if necessary; consequently, oPP is not bound to rely only upon the findings of the USDA/EPA assessment teams. The joint assessment team can be reactivat- ed by USDA if further data collection or analysis becomes necessary. Benefit-Risk Analysis The SPRD, in the person of the project manager, has responsibility for coordinating the risk and benefit analyses and for assembling appropriate decision-making (position) documents based on contributions from various offices in oPP. SPRD is composed of five chemical review branches and a Regulatory Analysis and Laboratory Audit Branch. At the conclusion of the benefit and risk assessments, an effort to weigh the benefits and risks is undertaken by the RPAR team under the general supervision of SPRD'S Regulatory Analysis Branch. The

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40 REGULATING PESTICIDES TABLE 2.2 Components of Pesticide Benefit Analysis (for a given site) and Principal Organizational Responsibilities in the Office of Pesticide Programs BFSD Branch Component Insecticides/ Rodenticides Herbicides/ Fungicides Current use analysis EPA registrations of RPARs and ASIBa PSBb alternatives Recommendations for use of RPAR and ASIB PSB alternatives Use of RPAR and alternatives EABC EAB Performance evaluation of RPAR and alternatives Pest infestation and damage ASIB PSB Comparative performance evaluation ASIB PSB Use impact analysis EAB EAB (projected change in use) Economic impact analysis Impact on production cost EAB EAB Impact on volume produced EAB EAB Impact on consumer prices EAB EAB Aggregated economic impact EAB EAB Limitations of analysis EAB EAB a Animal Sciences and Index Branch. b Plant Sciences Branch. c Eiconorruc Analysis Branch. Source: U.S. EPA (1977b). procedure involves determining trade-offs between risks and benefits associated with each regulatory option and presenting them to the Deputy Assistant Administrator for Pesticide Programs. The integrity of the individual benefit and risk assessments is not compromised since they have already been completed. Regulatory action recommended on the basis of the benefit-risk analysis is presented. Activity Flow As shown in Figure 2.4, the first step in the RPAR activity flow is "core" data collection and validation, and the development of a use profile for the RPAR pesticide. The data gathered during this initial stage are augmented and used during the entire scientific inquiry of the RPAR *

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FIERY and the RPAR Process 41 process. oPP's Program Support Division provides core data from registrant files, other EPA files, and most importantly a worldwide literature search that is done under contract and produces a list of abstracts. The abstracts are reviewed by oPP often by the project manager alone or with assistance from HED and complete studies are obtained for selected abstracts. Studies that are relevant to the risk assessment are subjected to a validation procedure (see the section on Scientific Review in this chapter). The next step is to determine routes of exposure. The project manager engages appropriate individuals from BFSD, HED, USDA, or outside contractors to determine routes of exposure on the basis of information about the chemistry and use of the compound. The early involvement of USDA, before the issuance of an RPAR notice, is important in order to begin fine tuning the mechanism for evaluating high-risk uses as opposed to low-risk uses. While the project manager is coordinating the risk data validation procedure and evaluating the status of existing and needed data, risk and benefit assessment teams are formed and begin initial analyses. The risk analysis involves linking uses of the RPAR pesticide with hazards considered valid. The HED develops a preliminary exposure profile, i.e., a rough estimate of the number of people exposed to different dose rates, using the core data provided by the project manager (see Chapter 4, section on Exposure Analysis). The early presence of an exposure analysis enables a clear articulation of potential risk in the issuance of the RPAR notice and PD 1. It also creates the framework for formulating preliminary regulatory options to reduce exposure that can then be used as background material for subsequent benefit and risk analyses. The preliminary exposure profile and hazard data are used to provide the initial risk analysis transmitted to the project manager for use in developing PD 1. The benefit analysis team begins the process of linking uses of the RPAR pesticide with economic and agricultural impacts attendant on the uses. This effort results in an initial examination of conditions that would be likely to result from cancellation, including use of alternative pesticides. The principal concern of a benefit analysis is assessment of the economic impacts a regulatory action would have on the pesticide users and on the consumers of the products of the users. The assessments are explicitly prohibited from considering any of the potential economic impacts a regulatory decision might have on pesticide manufacturers (U.S. EPA 1976: Appendix II). From the initial analysis, a plan of work is developed that will be shared with the risk analysis team and will be critical in selecting uses for in-depth analysis. The project manager, taking into consideration uses, potential expo

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42 REGULATING PESTICIDES sure, and toxicity data, drafts PD 1 or the statement of presumptive risk. If the risk criteria are reached or exceeded, an RPAR is issued. The RPAR notice should specify the extent to which critical information regarding exposure is unavailable, and requests should be made for this specific information. At the same time, additional data required for more definitive assessment of benefits and risks are identified and steps to acquire them are initiated. Following the RPAR notice, the RPAR team determines the uses of the pesticide to be analyzed in depth and develops a range of draft regulatory options. The determination of which uses to analyze in depth depends significantly upon data supplied by the USDA/EPA benefit assessment team. The benefit assessment team elaborates upon its initial estimate of alternative pesticides and the new use patterns that would result from the regulatory options that have been analyzed. The estimation of new use patterns is conveyed to the project manager and to the risk team. The risk team continues to validate or modify its initial risk assessment document and begins an assessment of the risks associated with alternative pesticides that would be likely to be used if a particular regulatory option regarding the RrAR pesticide were chosen. Meanwhile the project manager asks HED to conduct an analysis of rebuttals using HED staff and the CAG or contractors. Relevant information from this process is fed into the risk assessment. The rebuttal analysis and the decision as to whether the risk criteria have been rebutted are presented inPD2. The assessment of risks associated with current use of the RPAR compound is expanded by HED to include a comparison with risks from alternative pesticides that would be brought into use by the regulatory options being considered. Concurrently, the benefits team completes its assessment of economic impacts that would be expected to result from the previously formulated regulatory options. The project manager next reviews the risk and benefit analyses to determine whether they can be used to describe the benefit-risk trade- o~s associated with each regulatory option. A final group of regulatory options is then chosen, on the basis of the ability of changes in use patterns or use conditions to reduce the risks. The project manager, in consultation with the RPAR team, writes PD 3, which is a synthesis of the risk and benefit analyses. It describes and documents the risks and benefits associated with each regulatory option, and demonstrates the trade-offs between risks and benefits and the trade-o~s among risks when alternative options are considered. When possible, the relevant trade-o~s are displayed in a matrix, in which economic impacts of each

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FIFRA and the RPAR Process 43 option are presented in dollar terms and risks are presented in terms of numbers of anticipated morbidity or mortality incidences. For a more detailed discussion of oPP's current methodology for comparing risks and benefits see Chapter 6. Once PD 3 iS developed and approved, the proposed regulatory determination is drafted and sent to USDA and the SAP for external review. SCIENTIFIC REVIEW i' There is a consensus within EPA on the need for scientific review of the data base and positions formulated at the various steps in the RPAR process. There are several points in the process at which such review occurs. These reviews can be internal or external. Some are required by law, others have been created by EPA for the RPAR procedure, and still others are imposed by outside interests. The first scientific review, which occurs before the RPAR notice is ssued, involves only the risk data. The data base that is collected from the worldwide literature search to support PD 1 is subjected to a validation procedure. Validation is coordinated through the project manager and done either by contract, by in-house EPA scientists, or by a combination of these. It involves an examination of the test methodology or protocol, consideration of whether the results support the conclusions, evaluation of the study's weaknesses and strengths, and a general review of the value of the study to the RPAR process. Where cancer is an issue, this review is performed by the CAG. Once an RPAR is issued, a kind of de facto scientific review of the risk data and EPA'S assessment of it can occur through the rebuttal process. Often, major manufacturers will subject the scientific studies on which EPA'S RPAR determination is based to a very thorough review and at the same time will review EPA'S use of the studies in coming to its conclusions. These rebuttals, in turn, must be analyzed and evaluated by the project manager and the RPAR team. Again, if cancer is an issue, CAG is involved in the review. If the risk criteria are not rebutted, a draft position document (PD 2/3) is prepared with an appropriate benefit-risk evaluation and presented to the working group and the PCRC for their review (see the previous section on Administrative Responsibility in this chapter). The final scientific reviews are required by FIFED, as amended, and are performed by external bodies. These reviews occur when a tentative decision is made and a notice of regulatory intent is issued. The tentative decision and the supporting benefit-risk evaluation are submitted to the

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44 REGULATING PESTICIDES USDA and the SAP. The USDA iS expected to review the decision with respect to agricultural economics; the SAP reviews it with respect to human health and environmental factors. NOTE 1. Acute Toxicity (A) Hazard to Humans and Domestic Animals. mist or spray; (3) Has an inhalation LC50 of 0.04 mg/liter or less as formulated. (B) Hazard to Wildlife (1) Occurs as a residue immediately following application in or on the feed of a mammalian species representative of the species likely to be exposed to such feed in amounts equivalent to the average daily intake of such representative species, at levels equal to or greater than the acute oral LD50 measured in mammalian test animals as specified in the Registration Guidelines. (2) Occurs as a residue immediately following application in or on avian feed of an avian species, representative of the species likely to be exposed to such feed in amounts equivalent to the average Gaily intake of such representative species, at levels equal to or greater than the subacute dietary LC50 measured in avian test animals as specified in the Registration Guidelines. (3) Results in a maximum calculated concentration following direct application to a 6-inch layer of water more than 1/2 the acute LC50 for aquatic organisms representative of the organisms likely to be exposed as measured on test animals specified in the Registration Guidelines. (1) Has an acute dermal LD50 of 40 mg/kg or less as formulated; or (2) Has an acute dermal LD50 of 6 g/kg or less as diluted for use in the form of a Chronic Toxicity (A) Induces oncogenic effects in experimental mammalian species or in man as a result of oral inhalation or dermal exposure; or induces mutagenic ejects, as determined by multitest evidence. (B) Produces any other chronic or delayed toxic effect in test animals at any dosage up to a level, as determined by the Administrator, which is substantially higher than that to which humans can reasonably be anticipated to be exposed, taking into account ample margins of safety; or (C) Can reasonably be anticipated to result in significant local, regional, or national population reductions in nontarget organisms, or fatality to members of endangered species. Lack of Emergency Treatments Has no known antidotal, palliative, or first aid treatments for amelioration of toxic effects in man resulting from a single exposure. REFERENCES Calabresi, G. and P. Babbitt (1978) Tragic Choices. New York: W.W. Norton and Company, Inc.

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FIFRA and the RPAR Process 45 Carson, R.L. (1962) Silent Spring. Boston: Houghton Mifflin Co. Environmental Defense Fund v. Ruckelshaus (1971) 439 F 2d 584 (D.C. Cir.). Environmental Defense Fund v. U.S. Environmental Protection Agency (1971) 510 F 2d 1292 (D.C. Cir.). Environmental Defense Fund v. U.S. Environmental Protection Agency (1972) 465 F 2d 528 (D.C. Cir.). Environmental Defense Fund v. U.S. Environmental Protection Agency (1976) 548 F 2d 998 (D.C. Cir.). Keaney, K. (1977) A Guide to the Management, the Risk and the Benefit Activity Flows in Support of the RPAR Process. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. (Unpublished) Pesticide and Toxic Chemical News (1979) Carter budget proposes $81.6 million for taxies in fiscal year 1980. January 24, 1978, pages 1~15. Washington, D.C.: Food Chemical News, Inc. Pimentel, D., J. Krummel, D. Callahan, J. Hough, A. Merrill, I. Schreiner, P. Vittum, F. Koziol, E. Back, D. Yen, and S. Fiance (1978) Benefits and costs of pesticide use in U.S. food production. BioScience 28:772, 778-784. Seacoast Anti-Pollution League v. Costle (1978) 572 F 2d 872 (1st Cir.). U.S. Congress, House (1971) To Amend the Federal Insecticide, Fungicide, and Rodenticide Act and for Other Purposes (Federal Environmental Pest Control Act of 1971). H.R. No. 92-511, Committee on Agriculture, 92nd Congress, 1st Session. U.S. Environmental Protection Agency (1976) Health Risk and Economic Impact Assessment of Suspected Carcinogens: Interim Procedures and Guidelines. 41 Federal Register (102)21402-21405. U.S. Environmental Protection Agency (1977a) Pesticide Benefit Analysis Seminar: Session I, Overview of Benefit Analyses Under FIFRA. Briefing Materials. September 14, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. (Un- published. Available from A. Aspelin, Benefit and Field Studies Division, oPP.) U.S. Environmental Protection Agency (1977b) Plan for Benefit Analysis in the Office of Pesticide Programs, October 20, 1977. U.S. Environmental Protection Agency, Wash- ington, D.C. (Unpublished. Available from A. Aspelin, Benefit and Field Studies Division, oPP.) 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.