i SSSZ ^ Strategy of the | Environmental Protection Agency r for Controlling the Adverse Effects of Pesticides May, 1974 Office of Pesticide Programs Office of Water and Hazardous Materials Environmental Protection Agency ------- STRATEGY OF THE ENVIRONMENTAL PROTECTION AGENCY FOR CONTROLLING THE ADVERSE EFFECTS OF PESTICIDES May, 1974 Office of Pesticide Programs Office of Water and Hazardous Materials Environmental Protection Agency ------- io Sr 41 ____ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 THE ADMINISTRATOR The enactment of the Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1972 has imposed new responsibilities and authorities on Federal and State governments for controlling the adverse effects of chemical pesticides. The new legislation provides for several significant departures from previous mechanisms for dealing with pesticides and presents real challenges to the ingenuity, commitment, and foresight of all concerned - - regulators, the industry, and users. This strategy presents EPA 1 s policies and operational plans for implementing the new legislation. Pesticides do not recognize media boundaries, so the strategy also addresses the need for close coordination with other legislation concerning air, water, solid waste, and food, among others. I hope the fundamental need for cooperation among several Federal agencies, Regional Offices, and the States is clearly evident throughout this document. Successful balancing of the adverse impacts of pesticides against their real benefits depends heavily on uniform action and effective communications among us, industry, pesticide users, and concerned environmental spokesmen. The strategy is part of a management system conceived to implement the pesticides legislation. It should guide EPA Headquarters, EPA Regional Offices, and the States in setting annual objectives, allocating resources in support of these objectives, and regularly reporting on their achievement. It is meant to ensure that the many activities conducted under the 1972 Amendments, by conforming to a cohesive strategy, will complement each other. The strategy will be revised as necessary to reflect the changing circumstances of the national pesticides program. This document relates what EPA intends to do in balancing pesticide costs and benefits. I urge each reader to carefully consider its implications for you - - the importance of your role in the achievement of objectives set forth herein and your contribution to the evolution of an even more effective pesticides strategy. /Russe1l E. Train ------- COI TEflTS SLI 1hu\RY • 11 J NERODLILTION . . . . . . . . . . . . . ........... 1. PROBLEM SIATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 STRATECY OVERViEW . . . . . . . . . . • • • • • • • • , . . . . . . 9 PL 19 1. ------- StTh?IMARY With the 1972 passage of an atnendrient to the Federal Insecticide, Fungicide, and Rodenticide Act of 1947 (FIFRA), the Environmental Pro- tection Agency was given broad new responsibilities -— and powers —— to protect man and his environment from the adverse effects of chemical pesticides. This new FIFRA Amendment, the Federal Environmental Pesticide Control Act, comes at a time when pesticide benefits and costs require thorough reexamination. At the same time, the need for immediate controls Is evident. Accordingly, until October of 1976, the date for full implementation of the amended Act, the Environmental Protection Agency will pursue a course highlighted by four major thrusts. 1. By October, 1976, EPA must register and classify over 40,000 products in addition to its normal workload. This increase is a direct result of the amended Act: all new registration and classification actions must be based on an assessment of the unreasonable adverse effects of pesticides. This requires a comparison of the benefits of using pesticides with their costs. Accomplishing this huge task with available resources requires registration procedures fundamentally different from current ones. EPA will automatically re—register, on appli- cation, those products whose formulation ingredients and previous use records raise no significant questions of safety to human health or the environment. For those compounds that raise questions on the basis of accident history or chen ica1 composition, however, applicants will be required to submit full test and supporting data. These products will be subject to normal registration review. This screening process will focus EPA’s attention on those products which present the greatest potential hazard, will permit EPA to meet its peak workload at only modest resource increases, and, most important, will allow for the development of other important program activities. EPA will assure that products registered will continue to meet conditions of registration and classification through surveillance and testing of samples from producing establishments and the marketplace. 2. FIFRA, as amended, gives to EPA significant tools for the control of local health and environmental problems arising from misuse of pesticides. By requiring that applicators of potentially hazardous products be properly certified, by Improved labeling and packaging of pesticide products, by Th’.posing other regulatory restrictions as warranted, by timely enforcement against instances of misuse, and through public education programs emphasizing proper uses and dangers of pesticides, EPA anticipates a significant reduction in health and environmental effects. 11 ------- 3. A comprehensive hazard evaluation system is needed to better understand the nature and extent of adverse effects of pesticides on man and the environment and to provide a basis for program and regulatory decisions. EPA will significantly alter current prograirs —— pesticide monitoring, human health studies, laboratory experimentation, and special projects —— to more systematically acquire the inforration necessary for review of current and future pesticides. 4. An effective strategy for regulating the use of pesticides must take into account the technological, economic, organiza- tional, social, and physical environment of pesticide use and the changes occurring in that operating environment. Mindful of this, EPA is conducting and supporting basic scientific studies in ecological and human health effects of pesticides to support hazard evaluation and in the development of alternative pest control techniques. Principal near—term research emphasis will be placed on: • generating data to suppcrt current and anticipated litigation, • devising standardized laboratory test methodologies, • developing model ecosystems, and • identifying safer substitute chemical pesticides. Concurrently, policy studies will be undertaken, including: • collection of data and refinement of methodologies for cost—benefit analysis, • investigation of barriers and incentives for the adoption of improved pest control techniques, including integrated pest management programs, and • development of loni—term alternative EPA pesticide program strategies. While these four principal thrusts are being impletrented, EPA will develop a long—term pesticides strategy for the period coirinencing in 1977. The new strategy viii be designed on the basis of experience gained in administering pesticide supply and use control prograirs and in improving evaluation of pesticide hazards and from new knowledge gained in research and policy studies. 111 ------- 1 INTRODUCT ION BACKGROUND The benefits to man’s health, welfare, and comfort from the use of chemical compounds to control certain animals, plants, or micro—organisms are frequently offset by the deleterious effects of these compounds on the environment and on man himself. In the United States, enormous strides have been made in increasing and protecting food, fiber, and forestry products and ;Ln checking disease since the beginning of largescale pesticide use in the middle 1940’s. Domestic consumption of pesticides now amounts to almost one billion pounds of active ingredients —— more than half of that is used in agriculture. At the same time, the public has been increasingly concerned about the nature and extent of adverse pesticide effects. The need for Federal government involvement in the control of pesticides was perceived early and is principally addressed by the Federal Insecticide, Fungicide, and Rodenticide Act of 1947. Since 1970, the responsibility for administering this Act has rested with EPA. In October 1972, the Act was amended to give broad new pesticide control authority to the Agency. Fully implementing the Act, as amended, between now and late 1976 is an essential responsibility of the Environ- mental Protection Agency and strongly influences strategic planning for the period. Further, the new pesticide legislation must be coordinated with provisions of air, water, and labor legislation and the Food, Drug, and Cosmetic Act. PURPOSE The pesticide program strategy presented in this paper has been developed to clarify Agency policy with respect to lessening pesticide problems, balancing controls against the real benefits pesticides offer, and guiding EPA and other Federal and State agencies in implementing the control measures implied by the new law. This strategy is an operational plan. It describes what EPA will do in the period through 1976 in light of existing capabilities, legislation, and resource and other constraints. Actual resource needs will be specified in annual issue papers and detailed plans. However, this strategy has been predicated on a realistic estimation of future resource availability. 1 ------- Despite almost 30 years of intense use in this country, many facets of pesticides benefits and undesirable effects are only partially understood. Thus, a substantial part of this operational strategy is also devoted to uncovering the relationships between pesticides and man and the environment. To be updated as circumstances dictate, the modified strategy will reflect our growing knowledge, the success of past program actions, and changes in priorities brought about by Agency programs and external events involving pesticides. Thus, while this plan does not state EPA’s long—range pesticide strategy, it does provide the basis and mechanisms for determining that strategy. It also serves as the starting point from which detailed sub—strategies and program activities will be specified in the coming months. OUTLINE OF REMAINDER OF THE REPORT Chapter 2, PROELEM STATEMENT, briefly describes problems caused by pesticides —— including a summary of the important problem unknowns and trends. Chapter 3, STRATEGY OVERVIEW, describes policy decisions that directly affect the way the new law is implemented. Chapter 4, OPERATIONAL PLAN, details the important steps to be taken over the next three years in regulating and better understanding pesticides. 2 ------- 2 PROBLEM STATEMENT NATURE OF THE PESTICIDES PROBLEM Pesticides manufacturing, formulating, and sales are big business. In recent years, 1.3 billion pounds of pesticide active ingredients have been produced annually in the United States. About one billion pounds of pesticide active ingredients are consumed each year in the U.S.: 55 percent by the agriculture sector; 30 percent by industrial, institutional, and government users; and 15 percent by home and garden users. Therefore, any action regulating pesticide use must be based on a careful assessment of its effect on those activities to which pesticides represent an important, beneficial input——for pest control in agriculture, homes and gardens, industry, institutions, and government. Pesticides, unlike most air and water pollutants, are intentionally released into the environment —— where their acknowledged benefits are expected to take place. In fact, largely because of those benefits, pesticides now have become increasingly important to agricultural production, to public health and sanitation, to protection of capital investments and natural resources, and to improvement of human comfort and well—being. However, since pesticides are biological poisons that are seldom specific as to the time, place, or target of their chemical activity, their proliferation in the environment has caused serious health and environmental problems and may be causing others not now well under- stood. ADVERSE PESTICIDE IMPACTS Human Health Effects Ultimately, the most important of harmful pesticide impacts are those which occur in humans. Approximately 200 deaths each year (including a small number of suicides and homicides) are caused by pesticide poisoning —— a sizable fraction of all poisoning deaths in the United States. As many as 14,000 individuals may be non—fatally poisoned by pesticides in a given year, 6,000 seriously enough to require hospitalization. * *1972 Poison Control Center data imply ratios of 70 to 1 and 30 to 1 for non—fatal to fatal pesticide poisonings for cases with symptoms only and cases serious enough for hospitalization, respectively. The numbers shown in the text reflect these estimates, using 200 annual fatalities as a base. 3 ------- In general, more is known about exposure to pesticides than about effects, although some revealing data are available. For example, it is apparent that some population groups suffer higher risks of adverse effects than others. Householders The largest single group of individuals exposed to pesticides are those exposed to home and garden products. Children under the age of five are most often affected; they appear to have from two to five times higher incidence of fatal and non—fatal poisoning than the general population. Ingestion, the leading cause of children’s pesticide poisoning, frequently results from improper home storage of chemicals, packaging by manufacturers in breakable containers and containers without childproof closures, and application of products such as powders and baits in places where children can retrieve them. While many adult fatalities are the result of suicide and homicide, continued or repeated low—level exposure to certain home chemicals is nevertheless feared to cause long—term harm. Manufacturing and Formulating Workers Individuals occupationally exposed to pesticides, including manufacturing and formulating workers, applicators and their helpers, and agricultural field workers, constitute a second group at high risk to local pesticide exposure. No reliable national figures are available on acute pesticide poisoning in this group; even less is known about chronic effects. In general, recognition of the hazards has led to protection of pesticide workers through protective clothing and devices such as respirators, ambient air treatment, work station rotation, and health monitoring. Pesticide Applicators Some 40,000 commercial and up to 2,000,000 private applicators and associated workers are exposed to hazards from chemical pesticides in some of their most dangerous forms——unmixed, undiluted, and often in large, bulky containers. As their occupations require frequent handling of pesticides, applicators and helpers could be expected to be wary of acute poisoning dangers, and indeed there seems to be a relatively low incidence of poisonings. Systemic changes, the significance of which has not been fully established, have been measured among this group, however. 4 ------- The principal causes of these human effects are poor application techniques and equipment, failure to use protective clothing and devices, inadequate sanitation, and overall lack of knowledge about hazards —— largely from a simple failure to read, understand, or heed labels or from labels that are not sufficiently informative. Farm Field Workers Other than householders, farm field workers constitute the largest group at risk to pesticide poisoning——several million in the U.S. The principal route of exposure is dermal contact with pesticide residues on plant surfaces; of less frequency is direct exposure during chemical applications. Lack of protective clothing and equipment, lack of know- ledge of pesticide dangers, and, most important, premature reentry to treated fields seem to cause most field worker poisonings. Although few data are available on field worker pesticide exposure, a 1969 study conducted in California showed a thirteen—times higher incidence of individual field workers making doctor visits because of systemic pesticide effects than in a low—exposure control group. General Population Human health effects resulting from diffuse pesticides exposure are poorly understood. Arising both from food residues and from media contamination, diffuse exposure occurs principally from persistent and mobile pesticides. In addition, other compounds with lower persistence may be adding toxic metabolites and breakdown products to the environment. It is known that the body stores several pesticides and that systemic changes may result. Diffuse exposure causes particular concern because of the potential for long—term effects among large numbers of people. Environmental Effects It is not possible to summarize the total extent of environmental effects of pesticides across all ecosystem components. Locally, overuse, misapplication, improper storage, runoff, and improper disposal of pesticides have resulted in many wildlife and domestic animal poisonings, unintentional plant destruction, killing of beneficial insects, develop- ment of pest species resistance, and contamination of soil and water. Neither the short—term loss nor the prognosis for reversibility can currently be evaluated in most cases of local environmental damage. 5 ------- however, an ecosystem more diverse and numerous in species is a stronger and more stable system; it is clear, therefore, that serious damage can be caused and may have been caused already. Diffuse environ- mental effects appear to be largely an extension of local effects to a global scale. A great deal more study of the mechanisms that spread local problems is necessary —— including the modes of pesticide transport through soil, air, water, and biological routes and the effects of chemical properties such as persistence and bioaccumulation. UNKNOWNS The things we do not know about pesticide impacts——both positive and negative——may turn out to be more important than those things we do know. As a result, our strategy must be based on current under- standing while remaining flexible to information improvements. The most important areas of unknowns can be grouped into three broad classes. Problem Definition and Extent While the important types of pesticide problems have been identified, there are substantial gaps in both the qualitative and quantitative description of these problems. This information is necessary both to evaluate pesticide problems relative to other environmental problems and, more particularly, to be prepared to assess fully the costs and benefits of alternative pesticide control actions. A vital element of such an assessment is a clearer picture of what pesticides enter the environment, in what amounts, and in what locations. Further, more knowledge is required of the connecting links: What practices (e.g., failure to read labels, lack of protective measures, inadequate packaging, improper storage and disposal) allow man and his environment to be harmfully exposed to pesticides? Finally, it must be asked how such underlying mechanisms can best be controlled. Structural Uncertainties The most fundamentally difficult and in many ways most important unknowns, and the ones for which solutions can be predicted with least assurance, are those concerning the types and bases of physical/chemical/ toxicological interactions between pesticides and living organisms, particularly those resulting from low—dosage exposure over extended time periods. Still, this knowledge is germane to any understanding of both why pesticides work as intended and how they cause human health and environmental impacts. 6 ------- Differences in Interpretation of minimum thresholds and the significance of low—level, long—term exposures on a population at large make assessments difficult. Tumorigenic, carcinogenic, mutagenic, and teratogenic effects of certain pesticidal compounds have been observed in laboratory situations, but their implication for man Is inconclusive. The grave nature of these potential effects, however, dictates the need for prudence in allowing present use, for further directed research, and for imposition of restrictive control measures once significant risk is established. Beneficial Effects To have the capability for adequate cost—benefit analysis of pesticide control alternatives, the beneficial effects of pesticide chemicals must be better defined. As with pesticide problems, benefits of pesticides have been broadly categorized (e.g., agricultural production, disease control, structur s protection) but require considerably more systematic qualification and quantification. TRENDS Further worsening the difficult task of controlling Imprecisely defined problems are the effects of trends In the economic, technological, organizational, social, and physical environment; to these, the pesticide program strategy must be responsive, able to shift emphasis and change direction to most efficiently protect human health and the environment. Four trend areas are particularly important to the pesticide strategy. Resources: Various shortages could affect pesticide use in uncertain but possibly dramatic ways. On the one hand, increased world—wide demand for U.S. farm products would increase the pressures for more production through all available means, including pesticides. On the other hand, shortages of petroleum, a basic ingredient of many synthetic pesticide chemicals, could raise pesticide prices and reduce availability of pesticide products, forcing the use of more labor or acreage to achieve the same agricultural output. Changes in Types of Chemical Pesticides: Several factors, Including development of pest resistance, more effective chemicals, and regulatory actions, can cause old pesticides, often of known characteristics, to be replaced with new chemicals, frequently with substantially unknown effects. This process may be counteracted to some extent by rising costs of chemical research and development. 7 ------- Development of Non—chemical Control Measures: Biological, cultural, and other technological pest—control techniques may some day obviate the need for much chen ical pest control. However, effective control programs using both chemical and non—chemical controls are not now widely available or used. Agriscience Developments: In part a result of the above trends, changes in agricultural technology and economics give rise to new growing methods, improved crop varieties, and shifts among the production inputs. Each of these can affect the need for chemical pesticides. 8 ------- 3 STRATEGY OVERVIEW The goal of the pesticide program —— balancing the benefits of pesticides against their costs —— will be met through the achievement of four objectives: • assuring that products are acceptably safe and effective when used as intended; • assuring that products are properly used; • developing sufficient data and appropriate methodologies for assessing the hazards of pesticides; and • conducting scientific research and policy studies to support current and new programs of control. The first two objectives —— here called Supply Control and Use Control —— are intended to meet the statutory requirements of the new legislation. They are at the core of the EPA ’s near—term regulatory program. The third objective —— Hazard Evaluation —— is also rooted in the new Act. Its implications extend, however, beyond the immediate program. It represents an attempt to provide a firm scientific basis for both a near— and long—term regulatory program. The fourth objective—— Research and Policy Studies —— is aimed at both meeting current and new control objectives and also at supporting the development of the hazard evaluation system. SUPPLY CONTROL The backbone of the pesticide regulatory program is the registra- tion process. It serves to keep highly hazardous chemicals off the market and, through labeling, classification, and other regulatory restrictions, to control the use of others. It must also assure adequate availability of desirable pesticides whose benefits exceed their adverse impacts in use. The new Act requires re—registration and classification of currently registered pesticides by October 1976. A similar requirement applies to those pesticides currently registered by States for use in intrastate commerce. It is estimated that these statutory mandates will add over 40,000 registrations to the normally submitted registration petitions. The choice of a scheme to accomplish this enormous workload greatly influences the resources that can be allocated to other activities. 9 ------- All pesticides that have neither exhibited nor are suspected of causing significant adverse .npacts will be re—registered upon manufacturer application and without requiring further testing data. This determination will be based on groupings by chemical ingredients and safety—in—usc history for’ those pesticides long in use. Corres— ponclingly, full tesLin data, including results of animal toxicological studies, will he required to support re—registration petitions for those pesticides suspect because of ingredients or use history. This group of chen’ic ls t ay be subject to a complete review, comparing their benefits and costs, bc-fore registration. The review will include chemicals currently under administrative review in addition to others that have already been identified as having the potential to cause problems. Emphasis will be placed upon persistent and bio—accuniulative pesticides and those pesticides which potentially present long—term health risks or special d ngcrs to household users. Tho simple expedient of requiring manufacturer application before re—re ’istratior. will serve the further purpose of clearing out currently registered products that are no longer being produced. This, in addition to automatic registration of specified groupings of pesticides, will substantia]ly reduce the workload compared with product—by—product review process. There arc also other registration procedural efficiencies which must be considered in detail; these will be addressed by an EPA--wide task force. t number cf other policy issues have been raised concerning supply control. The registration process was long chiefly concerned with product elf .Lcaty since the time the original pesticide law as enacted in 1910. (tv r the years, the concern for hur’an and environmental safety I as been transformed into a requirement for industry to submit more hazard evaluation data to support their petiticris. Although this trend may well continue, EPA is still concerned with the need for proof of efficacy, since worthless pesticides that enter the environt”cnt create the possibility of risk with no off-setting benefit. however, lower priority will be given to efficacy evaluation in those areas where parties in addition to industry arc- involved in product development. This applies especially to agricultural pesticides whose development has involved land grant universities or other third parties. For those pesticides aimed at the Iior.e market or with direct public—health application, efficacy evaluation will continue to be an important part of thc registration process. As for the test data, no set of criteria can preempt expert judgment. however, standarized review rianuals, procedures, and methods will be developed for registration and tolerance—setting activities. ‘C ------- Standardized criteria and procedures will lessen the possibility of contradictory and uneven reviews and also reduce the amount of time needed to review each application. The possibility of requiring industry to use government certified laboratories to perform testing will be investigated as a further means of ensuring objectivity and standardization in data submissions. While the amended Act carries no specific provisions relating to the contamination of food, EPA will continue setting tolerances for maximum residual amounts of pesticides on food and feed crops under the mandate of the Food, Drug and Cosmetic Act. Tolerance setting remains as an important method for protecting the safety of the consumer. Ways of increasing the efficiency of the process will be explored, notably in reducing the time from manufacturer submission of a tolerance petition to EPA approval or disapproval. Although a regulatory agency, EPA recognizes the importance of ensuring that new and effective pest controls are developed. It is especially important to encourage innovative research and development from private sources. As one element of this program, regulations governing experimental use permits will be developed that fulfill the manufacturer’s need for new data as well as protect the environment during the testing period. Related to this is the minor use problem —— the unavailability of pesticides for uses which account for a relatively small percentage of pesticide sales. Manufacturers are often reluctant to submit such pesticides for minor use registration because the expense of additional testing and liability from damage claims are not economically justified. EPA will investigate methods of facilitating this process for second—party registrants. The continuing review of generic chemical classes Is another major element of supply control which will be given emphasis. In it, suspect products already in use are investigated to determine if their use raises substantial questions of safety. This process has tradi- tionally been an expensive and time—consuming one for all involved parties. Efforts will be intensified in speeding up this process. The first step In this direction Is a two—month mini—review of any suspect compound to determine whether a full review is necessary. This mini—review will be made on the basis of all available dara, including research and hazard data obtained during the re—registration process. Major effort will also be devoted to assessing the relative safety of potential alternatives to products under review. Supply control as underwritten by product registration must be enforced to be effective. A concerted program over the last few years of labeling and quality—control enforcement has reduced the number of gross violations of FIFRA registration requirements. The new Act gives additional enforcement authority in these areas through mandatory registration of establishments, through books and records requirements, and through surveillance at the point of manufacturing rather than in the marketplace. During 11 ------- the next two years the major effort will be directed toward the registra- tion and inspection of manufacturer and formulator establishments; reduced emphasis will be placed on market surveillance. USE CONTROL In addition to controlling the supply of pesticides, EPA will, in close cooperation with States, attack environmental and health problems that arise from poor use practices. Powerful tools to combat them are available in the new legislation. Labeling is a crucial step in assuring proper pesticide use. Labeling is approved at the time of registration if it provides adequate instructions and precautions to prevent unreasonable adverse effects. However, four factors bear recognition——the label is limited in the amount of information it can contain; it has been shown that users often do not read printed instructions; there is some question about how well any user understands labeling instructions even if he does read the label; and a user may choose not to follow the label. These factors suggest the nature of the use control strategy. A major thrust will be to restrict to competent applicators the use of certain compounds with a potential for causing localized damage. Such compounds will be available only to private applicators (farmers) and commercial applicators who have demonstrated competence in their use. This restriction should significantly reduce accidents by keeping hazardous substances out of the home and out of the hands of the untrained. Certified applicators* must know how to follow label Instructions, must know how to augment them when necessary (consistent with label intent), must know safety principles, must demonstrate competence in using application equipment, and must know how to dispose of unused pesticides. Also, since the first decision in pesticide use Is the Identification of a pest problem, certified applicators must be able to identify major classes of pests in their region. Applicators will be certified by States according to Federal standards. Enforcement of restricted—use regulations will be a joint Federal/State responsibility. P6S Lc information programs, including media advertising, will be investigated as a means of complementing the restricted—use program. Rather than emphasizing specific practices, these programs will be *The certified applicator program strongly interacts with the registration/ classification program described above. In fact, denying the registration of potentially toxic products is a clear alternative to restricting their use to certified applicators. During registration/classification, it will be determined whether a pesticide product will cause unreasonable adverse effects and, if so, whether further restrictions will diminish those effects. Certification programs are directed at guaranteeing that applicators of restricted—use pesticides are properly qualified. 12 ------- directed toward motivating the user to read and adhere to label instructions. Similar educational efforts have been attempted in the past but have suffered from a lack of message specificity and audience direction. The lessons learned from past efforts will be the basis for further development. In addition to restricting certain pesticides to certified applicators, the Act gives the Administrator authority to impose other restrictions on pesticides by regulation. This authority provides a powerful tool to be applied for both supply and use control of those chemicals capable of providing significant benefit but also substantial Costs to society. These other regulatory restrictions will be designed to achieve a satisfactory balance between benefits and risks associated with particular chemicals. Such other restrictions may include seasonal and/or geographic pound limitations on applications, annual permit requirements, control over distribution (including sale and purchase), allowing use of a pesticide only in conjunction with an integrated pest management system, and many others. EPA will develop a structured framework to specify what other regulatory restrictions will be applied under what conditions and to what extent. While these programs are expected to have major impact, certain other clearly needed programs will be instituted to deal with adverse health and environmental effects. These will include specific require- ments for childproof packaging for home—use products, disposal and storage regulation and enforcement, development of dissolvable packaging, and modified formulations of hazardous compounds. The development of dissolvable packaging promises a control of problems arising from direct inhalation and skin contact during mixing and blending operations. Current technology is adequate to meet this problem but details must be worked out. Spillage and food or clothing contamination during transportation will be controlled through promulgation of transportation and storage regulations. Protective clothing —— lack or nonuse of which has been implicated in large numbers of accidents to applicators and farm workers —— will be promoted. Today’s technology appears to be adequate to produce light—weight and comfortable clothing. However, Federal encouragement may be needed to bring about production and use of this clothing. Labeling may be employed to require the use of protective clothing and devices as necessary. Effort will also be directed toward mitigating adverse health effects among farm workers —— a sizeable group. State controls over reentry intervals (time between pesticide application and when workers return to the fields) will be reviewed by EPA. Preferably, enforcement at the Federal level will be a joint venture between the Department of Labor Occupational Safety and Health Administration (OSHA) and EPA enforcement personnel. Further misuse enforcement will be reinforced 13 ------- by evidence from crop residue reports (FDA), accident Investigations, and media monitoring. Enforcement against misuse relies in part on the provision that makes illegal the use of a registered pesticide in a manner inconsistent with its labeling. Consequently, a major effort will be undertaken to encourage the development and use of labels that are both Instructive to the user and enforceable in a court of law and to place in effect cost—effective compliance programs. HAZARD EVALUATION Under FIFRA as amended, pesticide registration and use may be approved only if unreasonable adverse effects on the environment will not result. Two types of dangers are associated with use of pesticides: foreseen dangers inherent in the pesticides even when properly used, and those either unforeseen or associated with misuse. Initial decisions on allowing these potentially toxic materials into the environment are made during the registration process largely on the basis of tests per- formed by the manufacturer under laboratory and controlled field situations. Unfortunately, such testing systems are Incapable of guaranteeing the extent to which toxic or other adverse effects In man and the environment can be expected when pesticides are put to practical use. On the contrary, the value of toxicological assessment of hazards using animals in the laboratory is fundamentally limited. First, the determination of an effect is a difficult and at times uncertain process. Second, large numbers of test animals are required to obtain confidence in dose—response calculations for a specified effect. Third, extrapolating such results from animals to man is as yet a very Inexact art. Fourth, the manner in which the product is used and moves in the environment may bear little relationship to the laboratory experience upon which hazard has been predicted. Finally, the test process cannot anticipate all possible serious effects. Through cancellation and suspension provisions, however, the amended FIFRA does authorize removal from the market of registered products whose use causes unreasonable adverse effects. Human effects monitoring, ambient residue monitoring, and accident surveillance systems now serve to alert EPA and provide supporting data for such actions as well as for periodic reconsideration of products and uses. A comprehensive, effective hazard evaluation system can thus serve EPA in a variety of ways. It can feed information into the registration process by identifying possible harmful effects of pesticides and their by—products. Decisions in the registration process are made many times over a long span of years as uses expand, as registrations expire and must be renewed, and when cancellation/suspension actions and reclassif i— cation actions are under consideration. Hazard evaluation provides a 14 ------- major input to these decisions. It can also identify chemicals re- quiring non—routine, in—depth review, and supply data which may either clear them for continued registration or support cancellation actions for specific classes or uses of pesticides. It can provide a basis for the design of control programs and information for use in making research and other non—regulatory decisions. Ultimate regulatory decisions must be based upon factors in addition to the hazards presented by pesticides. The hazard evaluation system is concerned only with the latter. Socio—econoinic data and other information will complement hazard data to permit an evaluation comparing risks and benefits and leading to the crucial decision as to whether a pesticide as used will produce unreasonable adverse effects. Under amended FIFRA, EPA will design and implement a hazard evaluation system which integrates toxicological testing with programs that provide data on the presence and effects of pesticides and their by—products in man and his environment. Using this design, EPA will consider to what extent existing hazard data programs will be continued and what new ones will be required. This major commitment constitutes the third thrust of the pesticide strategy. Extensive testing, monitor- ing, and surveillance programs have been in operation for a number of years. Performance has suffered, however, from a failure to properly structure and integrate the programs and the data outputs from the various components. The first step in the development of the hazard evaluation system, both conceptually and chronologically, will be the development of overall system design consistent with resource availability and technical feasibility. Second, the individual components will be developed, implemented, and integrated into an operating system. EPA must still meet its regula- tory responsibilities while this process is underway. Certain on- going programs involving field studies, monitoring, accident surveillance, and toxicological testing will continue while system design and program development and integration are underway. As noted above, data to support a hazard evaluation system can be generated both under carefully controlled circumstances, such as laboratory and experimental testing, and under essentially uncontrolled, in—use conditions, as through accident surveillance and monitoring programs. The former class is most useful in making early registration/classification decisions while the latter is most concerned with subsequent decisions including those associated with reclassification, suspension, and cancellation actions. This useful distinction masks the fact, however, that an effective system should integrate all information available at the time of any decision into a unified decision—facilitating apparatus. For this purpose, one primary activity will be the development of one or more model ecosystems as discussed in the next chapter. 15 ------- A very ambitious program has been outlined above. Fundamental scientific and policy problems must be addressed——problems not unique to the pesticides program but conmion to all attempts to control hazardous materials entering the environment. Even given the possi- bility of technological breakthroughs, the resource requirements to implement the program may be exceedingly high. However, a truly effective hazard evaluation system would be of extraordinary usefulness and significance. RESEARCH AND POLICY STUDIES The final thrust of the pesticides stra gy is toward a vigorous investigation both to support current regulatory actions and, more important, to develop data and analytical techniques and program options to meet future control program needs. The research program will have two major components: scientific research and model development; and studies to evaluate specific questions of policy and strategic planning. Research Currently, EPA is conducting and supporting scientific research in several areas of Importance to the pesticide program. First, in support of hazard evaluation, a better knowledge of harmful impacts of pesticides is being reached through a number of environmental and human health effects studies. Second, EPA is supporting research in integrated pest management, as i& the Department of Agriculture, through both cooperative and independent investigations. Third, improved techniques, equipment, and laboratory methods are being sought for monitoring pesticide levels in man and the environment. Finally, problems involved in safe disposal of waste materials are also being addressed. In addition, new emphasis will be placed upon certain areas of scientific research. Research will be intensified toward supporting current and anticipated litigation on chemicals suspected to present unreasonable hazards to health and the environment in direct support of the hazard evaluation system. Of particular concern are chemicals which bioaccumulate or present special toxicities. Although the EPA research burden will be eased by requiring manufacturers to submit extensive data to support their petitions for re—registration, there still remains a significant short—term research need to support review of suspect chemicals. Many of the chemical families currently in use may be expected to continue in use for the next decade or more. Furthermore, because of their extensive use in the past and continuing existence in the environment, they provide an excellent subject for health and environmental effects research. 16 ------- A second new emphasis of the scientific research program will be the development of improved laboratory test methodology for current compounds and development of standards for testing protocols and registration requirements for anticipated pesticides, including biological controls. Standards for test methods are needed for three pesticide regulatory functions: (1) determination of the efficacy of products as a basis for registration; (2) as a basis for enforcement actions, hearings, or other proceedings; and (3) determination of specialized toxic reactions. Actual testing will continue to be an industry responsibility. A third emphasis of the scientific research strategy will be the development of model ecosystems, proceeding from the current state of the art. The models will predict human and environmental hazards on the basis of chemical properties and expected use patterns and serve as a basis for well—founded design of more efficient and effective hazard evalua- tion programs. An EPA research program will also be carried out to systematically identify safer alternative chemicals for pesticides in common use, accounting for relative efficacy, impacts, and costs. This is particularly important so that possible future cancellation or restriction actions do not result in unacceptable user hardships or food shortages. Policy Studies Policy studies will complement scientific research. Through socioeconomic and system investigations they will better define the nature and scope of pesticides problems and thus lead to improved long—run programs. Five major areas have thus far been identified in which studies will be performed. First, methodologies will be developed to give quantitative support to the notion of “unreasonable adverse effects.” Since, according to the new Act, registration and cancellation/suspension actions must take into account the economic, social, and environmental costs and benefits of the use of any pesticides, this concept underlies a major part of the entire regulatory program. Studies will be undertaken to improve the quantitative determination of the costs and benefits resulting from pesticides use. Second, studies will be performed to develop viable options that stimulate the development and use of improved pest control techniques. These will be directed at determining the extent to which regulatory actions affect industrial innovation; the need for incentives in encouraging private research; and the potential impact of government testing, regulation, and—other--mechanisms for directing research activities. The Act directs that research priority be given to biological alternatives and integrated pest management. While the actual develop- ment of specific alternative pest control techniques will largely be the responsibility of other Federal agencies, studies will be made of institutional factors in their development and use. Under 17 ------- its authority to provide special restrictions when necessary to prevent unreasonable adverse effects on the environment, EPA may, for example, allow the use of a particular product only if it is part of an integrated program of pest management. Third, program strategies that differ significantly from the current one of controlling the supply of pesticides and of preventing their misuse will be investigated. Such options as demand control through crop insurance programs; taxes on products related to social costs of their use; and more refined controls, such as prescription systems or licensed pest—control advisors, will be explored. Fourth, studies of how to increase the operating efficiency and effectiveness of EPA’s supply and use control activities will also be made, including evaluation of how the authorities of legislation other than FIFRA —— air, water, labor, and food and drug acts —— can best be utilized to both complement and supplement pesticide legislation. Fifth, a major study of the future (the years 1985 — 2000) will be initiated. Since agricultural policies, population trends, food demand, resource depletions, and other economic factors are the context in which regulation takes place, a forecast of alternative future conditions is important to any longer—term strategy. 18 ------- 4 OPERATIONAL PLAN The previous chapter has outlined the major elements of the EPA pesticides strategy to be pursued over the next three years. This chapter presents specific program plans. Although there are numerous activities necessary to meet objectives, these will be presented in detailed operating plans for each fiscal year. However, detailed implementation plans for important segments of this strategy will be initiated immediately. SUPPLY CONTROL The program activities primarily related to control of the supply of pesticides reaching the market place are incorporated in: (1) registration and classification of pesticides; (2) review of suspect chemicals and then suspension/cancellation/reclassification actions as appropriate; (3) distribution and sales control; and (4) enforcement and compliance control. The former two of these areas are principally headquarters responsibilities, while the latter two will progressively be the responsibility of Regional Offices and States. Actions of EPA Headquarters Principal EPA headquarters activities will be to: • issue regulations for experimental—use permits; • accomplish the registration and classification of over 40,000 pesticides; • develop restrictions applicable to pesticide products; • develop and improve registration and enforcement data handling systems; • conduct review of suspect chemicals; • issue regulations defining book— and recordkeeping requirements for pesticide producers; and • assure full compliance with regulations under the amended FIFRA. 19 ------- SUPPLY CONTROL SUMMARY Major Actions and Milestones FY 74 FY 75 FY 76 FY 77 Experimental Use Permit Regulations XX Experimental Use Permit Monitoring — _______ _______ _______ New Registration Regulations Re—registration/Intrastate Registration — Product Guidelines for Re—registration XX State Registration Analysis and Guidance Improved Registration Data System Chemical Reviews Review/Improvement of Registration Enforcement — ________ ________ ________ Establishment Registration and Records Regulations XX Coordination of Regions/States Registra- tion Enforcement Regions Restricted Use Surveillance Plans XX Structure Other Regulatory Restrictions ________ ________ _______ 20 ------- Experimental use permit regulations, which provide the first opportunity for EPA to apply controls to a particular product, will be issued for public comment in March 1974 and in final form within an estimated three months; until that time, procedures under the 1947 FIFRA remain in effect. Following regulations, specific guidelines wi1l be issued establishing data requirements for permits, safeguards to protect experimental users, and reporting requirements. The registration process must cope with re—registration and classification of some 32,000 previously Federally registered products... It must also review, register, and classify an estimated 12,000 products now registered by the States only, from October 1974 to October 1976, in addition to nortrai annual workloads of some 35,000 actions. Special procedures uill be required to assure efficient, effective handling of registration during this transitional period. However, through improvements and changes in the system as outlined below, it is anticipated that a 100 — 200 percent increase in workload can be handled by a moderate increase in resources. After the major -transition, these process improvements will allow a resource decrease of up to 50 percent to handle the future workload projected for FY 77 (last three quarters) and beyond. E r1y guidance to industry on both registration and classification aspects of currently registered products is important. It will provide a smooth transition for EPA and an opportunity for industry to pre- pare additional data in an orderly fashion. EPA will issue final regulitions for registration and classification by October 1974. During past years a considerable body of knowledge and independent data have been gathered by EPA. On that basis, guidelines will be provided which will identify those product types that EPA would propose to re—register on the basis of: (1) simple application of the manufacturer; (2) minimal basic data; and (3) complete test data consistent with standards. Similarly, guidance will be issued on product types which EPA would propose to subject to a case—by— case review for classification to restricted or general use and those which would be considered initially for the general—use category with only minor label amendments. Procedures for processing new registrations, as well as for re—registration of currently registered products, will be contained in registration regulations to be promulgated in October 1974. Federal registration of products previously registered only intrastate will depend upon the quality of the original State review procedures and upon the extent of review which would be applied to a similar Federal registration. Analysis of State registration processes will be completed by September 1974, and guidance will be Issued within the next quarter. 21 ------- Registration guidelines, to be issued by June 1974, will appear in a looseleaf updatable format and will initially specify registration submission requirements applicable to 50 to 60 percent of all products. By the end of FY 75, EPA expects to issue specifications for test methods. By the end of FY 76, further expansion and detailing of the guidelines will be accomplished to objectively define requirements covering 80 to 90 percent of all products submitted for registration. This will leave only the most difficult registrations for review outside the guidelines. Requirements for efficacy review when supported by third party testing (except for public health uses) will be deeniphasized in favor of human and environmental effects. As Federal registration begins to incorporate intrastate products, provisions for special circumstances and minor uses of a local nature will be critical. flegulations and guidelines for State certification under a special local need program will be issued in October 1974. Regulations governing exemptions from the provisions of the Act for Federal and State agencies under emergency conditions are now in effect. Other regulatory restrictions, as provided for in the registration authority of amended FIFRA, will play an increasing role in supply control, particularly in those cases where: (1) total poundage released to the environment is critical; (2) hazards are presented to non—target organisms, including man, which can be limited more efficiently than by restriction to use by certified applicators; (3) benefit/risk relations may be improved by simply confining use to within a total pest management program; (4) specificity and care in the decision to use are particularly important to avoid potentially serious effects remote in time or distance from the application site; and (5) other special cases which may arise from time to time. EPA will structure during FY 74 a plan to determine when, where, and to what extent these special restrictions should be applied. The intent is to establish consistency of control where environmental protection requires restrictions other than or in addition to those available through certified applicator regulations. Key elements of a supply control program consistent with an efficient, effective internal operation will be put in play by October 1974 and will include: • computerized data and information—handling facilities for registration, chemical reviews, and regional support; • internal review criteria and guidelines for registration personnel to apply existing data in a consistent way in making registration decisions; and • improved access to monitoring and enforcement data. 22 ------- Initial registration cannot anticipate the potential consequence o cvery registration or classification action. EPA must therefore conduct a review program. Generic reviews of chemicals will continue to deternine the benefits and risks of continued use——clearing some compounds and restricting others to varying degrees. Over 100 suspect chemical substances have been identified to date. Even though the more efficient new procedures of mini—reviews followed as necessary by full reviews are employed, this process could take well past the year 2000 at the current rate of 6 to 8 compounds per year. Additional major resource emphasis must therefore be devoted to this area. Priority emphasis is planned for: (1) “genetic” effect home and garden compounds and (2) large—volume/use compounds with potential for persistence and bioaccuirulaticn. Safer alternatives for suspect chemicals will be sought through a formal review and research program. A systematic effort is now being mounted to identify and evaluate the relative merits of possible substitutes for potentially hazardous chemicals. Compliance with the registration requirement of FIFRA is monitored through a random sampling scheme determined by the EPA Office of Enforcement. Enforcement intelligence gained from this program —— as carried cut through Regional Offices —— as well as from the selective sampling of products and firms with known violation histories, will be reviewed at the end of FY 74 to determine if program modifications are necessary. The change in surveillance emphasis from the market- place to establishments, which was begun in FY 74, will continue to more efficiently ensure that unsafe products do not reach users. Regulations for establishment registration, requirements for books and records, and inspection schedules are now being developed and will be operational by late FY 74. These regulations will be important to EPA’s ability to track product dIstribution and to structure an effective sampling scheme. Actions of Regional Offices In controlling supply of pesticides, Regional Offices will: • survey compliance with experimental use permits; • help develop “special local need” registration programs with States; register all pesticide producing establishments; and play the primary role In enforcing Federal registration provisions. Regions will continue to monitor performance of experimental use permits to assure that permit conditions are being met and that unforeseen events of a significant nature are immediately made known to Headquarters. Enforcement actions to prevent or prosecute violations are e Regional responsibility. 23 ------- Regions will also play a key role in working with States to develop and monitor State performance under certified plans and enforcement agreements in the areas of: (1) experimental use permits, which a State may issue (if approved) and (2) a program of registration of pesticides for special local needs. Although EPA Headquarters will review and approve State plans and specific State local need regis- trations, regions will be expected to (1) monitor the extent of use of local need registrations, (2) provide necessary Federal enforcement, (3) comment on State plans before approval, and (4) comment on specific State registrations with respect to nature of local use, expected extent of use, and environmental impacts. Regions will continue as the primary EPA element in registration compliance surveillance and enforcement and will continue to sample products under Headquarters guidance, carry out chemical laboratory analyses, and take enforcement actions. During FY 75 coordinated programs will be developed by Regional Offices with States to avoid duplication of efforts. Compliance surveillance by Regions of sale of restricted—use pesticides should be programmed for FY 77. State Responsibilities States desiring to register pesticides for special local needs or to exercise other authorities delegated by FIFRA must submit plans to the Administrator after the Federal regulations are issued. Plans must provide assurance of: (1) adequate technical review capability; (2) surveillance of experimental uses; (3) appropriate authorities to take remedial actions to revoke permits or registration; and (4) procedures and authorities to assure consistency with Federal registration and classification policy. A Federal/State cooperative enforcement program is being developed to involve States in programs of product supply surveillance and enforcement and to avoid duplication. Although resource constraints are significant, it is evident that an increasing State partnership will be required. Other Federal agencies, particularly USDA, must contribute to the fund of knowledge available for supply control, including: (1) sponsorship of pest control research that must be publicly provided in minor use areas; and (2) identification of ttessentialte uses, benefits, and alternatives during chemical reviews. USE CONTROL The current major regulatory thrust in use control is provided by classification and applicator certification. The new enforcement and 24 ------- USE CONTROL SUNNARY Major Actions and Milestones FY 74 FY 75 FY 76 FY 77 Applicator Certification Standards XX State Certification Program Guidelines XX Product Classification Standards XX Applicator Certification Training Demonstration Projects Improved Labeling Regulations XX Public Education Programs Product Packaging Requirements Agricultural Worker Protection Standards XX Food Tolerance Improvements XX Cocperative Regions/States Use Enforce- ment Plans XX Product Storage, Transport, and Disposal Procedures and Regulations State Certification Program Plans Submitted Cooperative EPA/OSHA Reentry Surveillar ce Plans ________ _______ ------- penalty provisions are expected to enhance both these control measures. Classification and certification can provide control over significant problems of applicator, farm worker, and local environmental hazards while alleviating diffuse problems stemming from misuse and overuse. Regional Offices and States will play key roles in implementing and enforcing all use controls. Other regulatory restrictions, discussed under supply control, will also be investigated as a means of improving use control. Actions of EPA Headquarters EPA headquarters will issue; • Standards of competency for certified February 1974 (Proposed) applicators June 1974 (Final) • Regulations for State Certification September 1974 Programs • Regulations for Classification October 1974 (Effective date applicator certification October 1976) Technical assistance for applicator training and development of State plans will be provided xd.th.in available resources. Demonstration contracts are currently being developed to test alternative methods of training applicators and to assess innovative methods of training. These will be completed by mid FY 75; results will be made available to the States beginning in September 1974. Labeling is a key tool in both user information and enforcement. Significant improvements will be required to improve clarity and coinprehensibility of labels. Studies carried out over the past three years have provided insights into needed improvements; these will be implemented durinp the 197^-76 re-registration period. A labeling symposium will be held in FY 1974. Public education through a media-oriented program will be instituted in FY 75 on an experimental basis to enhance the potential benefit of improving labeling. Studies have shown that the majority of users do not now read labels. Media spots directed at the potential hazard of improperly handled pesticides and the value of label infor- mation have beer, shown effective in some cases. Use-control programs will depend upon a mix of regulation, education, and training directed toward voluntary compliance and enforcement. Enforcement strategies in such a broad new field are difficult at best and are irade irore difficult by resource constraints. 26 ------- A 10 to 20 percent shift in product surveillance resources is planned for FY 75 to initiate misuse enforcement programs. Short—term emphasis will be on design, testing, and development of cooperative Federal/State strategies. A substantial degree of compliance by certified applicators can be expected since loss of certification could result from violation of FIFRA. Packaging requirements for home—use products to prevent child poisonings will be prepared in cooperation with the Consumer Products Safety Commission and will be incorporated in re—registration review of all such products. A variety of other Headquarters activities impacting on effects of pesticide use include: • Standards for agricultural worker protection are now in preparation and are scheduled for publication before the 1974 growing season. • Plans for the surveillance of field reentry conditions will be developed cooperatively with the Occupational Safety and Health Administration (OSHA). • Food residue tolerances established under the Food, Drug, and Cosmetic Act will continue to be a strong motivation to proper use of chemical pesticides on food and feed to avoid confiscation and loss of crops under FDA enforcement programs. To simplify the numerous tolerances now in effect, EPA will seek to develop crop groupings and codify existing tolerances in 1975. These crop groupings will also be helpful in allowing pesticides cleared for one crop to be used on similar crops produced on a much smaller scale——the so—called “minor crops.” • International tolerances established by the Codex Alimentarius Commission have a direct impact on international trade positions and on domestic tolerances. Increased attention will be paid to this area. • In cooperation with the Office of Solid Waste Management, recommendations dealing with safe storage and disposal techniques for pesticides and containers are being developed; prel1n inary guidelines have already been published. • The Office of Water Programs will be designing regulations dealing with water pollution from pesticide runoff, including non— point—source control. • Pesticide transportation regulations, where now incomplete or inadequate, will be developed through cooperation with the Department of Transportation. 27 ------- Actions of Regional Offices Regions will gradually assume a major EPA role in use control. Resources devoted to use control should be increased significantly by F? 76. Regions will help the States develop their certified—applicator programs and will provide final review and approval of State plans. They will also monitor performance under approved plans. Regions must become familiar with applicator training techniques and provide technical assistance to States. Regions will also work with media organizations in promoting public service materials for safety—in—use programs. The groundwork for cooperative—use compliance programs with States should start in FY 74 in coordination with Regional activities related to applicator certification. States will be encouraged to obtain adequate legislative bases for misuse enforcement if they do not currently exist. Regions will also cooperate with the Occupational Safety and Nealth Administration (OSFJA) in a sharing of information concerning field reentry and factory worker surveillance. Regions will extend national interagency agreements with USDA Extension Service into States where they currently do not exist and assure that States, in developing applicator training programs, make maximum use of existing capabilities. Monitoring of program performance and environmental impacts arising from emergency condition exemptions for State and Federal agencies will be carried out by Regions with reporting to Headquarters. Regions will also coordinate with States in assuring compliance with pesticide storage and disposal regulations and implementing local disposal plans and systems. State Responsibilities States must play a primary role in use control through training a necessary and certifying applicators and executing appropriate post— certification control. States must submit plans for certification programs by October 1975. Although States will need specific legislati e authority, to be detailed by March 1974, conditional approval may have to be given to plans which identify such authority as pending. State cooperative enforcement programs are essential to adequate FIFRA implementation. Existing state enforcement programs are uniquely. qualified to fill certain deficiencies in Federal enforcement capabili- ties. Cooperative efforts with other agencies will form a major basis of use control due to the magnitude of the task and the diversity of use control needs and potentials; duplication must be avoided and 28 ------- expertise of agencies outside EPA fully utilized. Enforcement of worker protection standards is expected to be carried out cooperatively with OSHA in the Department of Labor through cooperative State programs for worker protection. HAZARD EVALUATION Hazard evaluation programs have traditionally been directed by Headquarters. This orientation will continue through FY 1976. The hazard evaluation programs conducted up to the present time have included human and environmental monitoring and accident and incident reporting, as well as the traditional toxicological testing programs and experimental use programs conducted by applicants for registration. Major emphasis through FY 1976 will be on design of an overall system —— review and restructure of existing component programs, development of new programs, and the integration of program outputs. The objective is a comprehensive, operational system responsive to EPA’s decision— making needs. Neither the difficulty of designing nor the resources to operate the system should be underestimated. Allowance must be made for the fact that many crucial aspects of the relationships between pesticide use and human and environmental effects will not be clearly known in the near future. System conceptualization and overall design will be the primary focus through FY 75. An essential element will be the integration of hazard data of varying types and quality, made available from multiple sources. Integration implies a way to relate and compare data on different aspects of a pesticide use situation so as to display the relative significance of the various hazard aspects of the pesticide use and to help in evaluating total hazard. Integration of data should help in posing useful hypotheses about kinds of hazards for which there are no direct data; such hypotheses might be drawn from data available on other hazards and from analagous pesticide use situations. An important component of the integration effort will be the development of one or more model ecosystems. A model eco ystem should provide a means for interrelating laboratory toxicological data, environmental levels and effects data, human levels and effects data, and use and other•data. Design of the model ecosystem iil1 require an understanding of interactions among ecological subsystems; the model itself will in turn facilitate additional understanding of these relationships. Such a model would prove a framework for field testing, and would lead to the identification of organisms and subecosystems in which to monitor for ambient pesticide alert levels. Modeling of such biological systems is now primitive. However, the availability of a better framework for understanding the relationships and impacts of pesticides in the real environment would justify the effort needed to construct improved mode1’ ecosystems. 29 ------- Monitoring systems will be designed to acquire data on human effects both immediate and remote in time and place from the application site and also both acute and chronic in nature. Review of programs conducted up to the present, especially the epidemiological studies, and their redesign, or the design of completely new programs, will be a major activity in FY 1974 and 1975. A basic question is whether such programs can be designed and carried out with the resources likely to be available and still promise output justifying the investment. Design studies must consider: (1) rules for deciding which study populations and which pesticides to observe; (2) statistical integrity and design of samples from populations to be studied; (3) other aspects of study design including long term followup of the observed population; (4) ease of integrating results with those from other data acquisition activities into the hazard evaluation system; and (5).managerial and organizational arrangements insuring quality in performance over the life of the studies. To accomplish this, the most capable experts available, in or out of government, will be retained. Completion of this effort is projected for inid—FY 1975. Monitoring of pesticides and their effects in parts of the environment other than man also involves the acquisition of data on both immediate and remote phenomena. The ambient environmental monitoring programs carried out by EPA and others under the general design (1967) of the Federal Working Group on Pest Management are being reviewed in connection with development by EPA of a National Pesticides Monitoring Plan as required by the amended FIFRA. The Plan and its components must be completely integrated into the hazard evaluation system. Review, re- design and development of environmental monitoring programs will entail development of a rationale for selecting the pesticides to study; for selecting the environmental media, organisms, and ecosystems on which to acquire data; and for decisions on sample selection and other aspects of integrity and usefulness of the programs. In addition to long term, ongoing environmental monitoring programs, short term projects will be designed and conducted to acquire information on the environmental’ behavior of pesticides or uses of special significance, because of highly suspected hazard or for other reasons. These special studies must also provide results that can be integrated into the hazard evafuation system as well as serve their more immediate purposes. Some resource will be reserved and kept in readiness to carry out such high prioritfy, largely unforeseeable projects. Another major program contributing to the hazard evaluation system will report data on accidents and other incidents Involving pesticidel. Existing EPA activities are being reviewed, and a program will be (‘ designed to provide coverage and accurate and useful data consistent with resources. The extent and method of investigation of Incidents, 30 ------- comparability of data, statistical validity and other design and managerial issues must be addressed. The Regions, together with State and local agencies, will play a major role in the acquisition and sub- mittal of such data. In addition to the acquisition of data bearing directly on hazard, alerting (alarm level) programs will be designed and implemented, if possible by adding them to other data acquisition programs, to provide indicators of potential hazard. At the present time, knowledge as to the relationship between the presence of pesticides or their break- down products in environmental media or organisms and adverse effects is not sufficient to define danger levels. Under these circumstances, the “trigger” level in the alerting system may initially be set at levels presumed to be below those at which control action would other- wise be appropriate. Data showing the presence of a pesticide at the trigger level should thus not foreclose the opportunity to conduct special research and data acquisition before occurrence of wide—ranging, significant health or environmental effects. The usefulness of the alarm mechanisms should be enhanced by improvements in model ecosystems. Studies will (1) develop rules for deciding which compounds, ecosystems and indicators to use; (2) develop the rationale for determining the trigger level; (3) develop the course of action to follow after alert - levels have been triggered; and (4) design the operating system for acquiring the data. Design of the hazard evaluation system and design of its coitponents will not be completed until sometime in FY 1975. In the meantime, decisions must be made as to whether to continue current programs, with appropriate adjustments in resources and emphasis. Considerable attention has already been given to the development of a program strategy for this interim period. Under consideration are: (1) a trial experimental—use surveillance program; (2) a compilation of data gathered during previous efforts; and (3) special short term projects, particularly in the area of acute effects on agricultural workers. A decision on the short term program strategy will be made in the near future. T he Regions can contribute significantly to hazard evaluation system design efforts overall during FY 1974 and early FY 1975 by cata]. oging and reporting on ongoing pesticide monitoring and accident reporting activities within the areas for which they are responsible. Other Federal agencies currently play major roles in monitoring and data acquisition, and will be expected to continue to do so. Their cooperation is essential both to the redesign and implementation of a national monitoring plan. 31 ------- RESEARCH AND POLICY STUDIES The fourth strategic thrust consists of a flexible program of directed research and policy studies. While important elements of this program can now be identified, a capability to quickly redirect certain elements must be maintained so that the program ca i fully support an evolving strategy. Primarily a Headquarters effort, Regions will be asked to support research and policy studies on the basis of their experience and specialized expertise. Research Program EPA is now conducting and supporting a scientific research program directed both at providing support for pesticide regulatory actions and toward establishing a firmer understanding of pest control methods as they impact on man and the environment. The current research program is composed of a variety of both short and long term inves- tigations. The amended FIFRA, and this strategy, impose new requirements for changes in emphasis among some of the research efforts. Currently, scientific research is being carried out in three broad pest control areas. Effects Development of an operational hazard evaluation system requires that many unknowns concerning pesticide effects be addressed. Several longer term investigations (3 years or more) of both ecological and human health effects are now underway or planned: • baseline studies of a relatively uncontaminated ecosystem to allow measurement of net chemical effects; • development of methodologies for assessing pesticide effects in particular environmental systems; • studies of synergistic effects of pesticides in combination with other pollutants; • studies to quantify transport, transformations, degradation, and fate of pesticides in the natural environment; • development of pesticide/fertilizer runoff models; • expanded and improved laboratory studies of pesticide toxicities to man. Alternative Pest Control Methods The Department of Agriculture has a large program devoted to developing alternatives to chemical pest control. EPA ’s research here is directed at supplementing this program, filling in gaps that 32 ------- may occur and involving segments of the research community not traditionally involved with agriculture. Two principal studies being supported in part by EPA are: • a study of the potential for alternate pest control methods for seven major crop types; • a study of control alternatives for soil insects. Both studies are concerned with pest populations dynamics and inter- actions, damage thresholds, natural enemies and resistance, and new control possibilities. The objective of both USDA and EPA programs in integrated pest management is the availability and use of pest control methods, including selective chemicals use, which permit adequate control with reduced unwanted effects on man and the total environment. Other Research Current research efforts are directed at filling several other important needs: • development of new methods, techniques, and equipment for monitoring pesticides in the environment; • provision of standard reference materials, analytical techniques, and samples for residue laboratory work; • assurance of inter—laboratory quality control in analysis of monitoring samples; • development and evaluation of technology for recovery and conversion of pesticide waste materials; • attention to the problems of field worker exposure and means of establishing safe reentry conditions. The pesticides strategy has several implications for the relative emphasis among research topics. Higher near—term priority will be given principally to four areas. • Research in support of chemical reviews and litigation will be of high priority between now and 1980. In many cases, basic groundwork must be accomplished to quantify specific chemical effects and interactions as described above. In most anticipated review/litigation cases, the capability for rapidly acquiring quality research results will also be required. 33 ------- • Also of high importance will be research projects to develop product test methods and protocols. For eventual use by both industry and government, two particular needs are evident: (1) tests for new generations of pesticides such as viruses and hormones to assess potential for hazard; and (2) tests to establish the efficacy of public health products, including disinfectants. • The linkages among subsystems of the environment for use in models to support the hazard evaluation system will also be developed. Model development must proceed carefully yet rapidly from a generally primitive base. In this regard, relationships must also be developed for relating laboratory experimentation to real world effects. • A large effort to systematically identify safer chemical alternatives to currently used pesticides is being initiated. This substitutability among chemicals must take into account the relative efficacy, impacts, and economics of alternate chemicals. EPA must be in a position to recommend the best available pest control methods in the event of cancellation or use restriction of pesticides now in common use so that unacceptable economic impacts or food shortages do not result. Policy Studies A major focus of the next two years will be a series of policy— oriet ted studies to explore direct and indirect determinants of pest’icide demand, pesticide benefits, alternative pest control options, and institutional mechanisms and constraints. Some of these studies are currently underway or about to be contracted while others will be initiated during FY 75. First round studies will be completed by the end of FY 75 and the remainder in FY 76 to form the basis for pesticide strategy in the period following full implementation of the amended FIFRA in October 1976. The following five study areas will he pursued: 1. The foundations will be set for the assessment of pesticide costs and benefits, including an operational definition of “unreasonable adverse effects” of pesticides as referred to in the amended FIFRA. Several specific EPA studies include: • a review of applicability of cost—effectiveness methodologies from other fields; • assessments of the magnitude, Impacts, and control of pesticide pollution from urban usage and agricultural non—point sources; • a study of the factors underlying crop yield increases; • an evaluation of the effect of food quality and appearance standards on pesticide use. 34 ------- 2. The EPA role in and alternatives for influencing Integrated pest management will be assessed. A preliminary report is to be cor.:pleted by the end of FY 74. Additional efforts in this area are: • evaluation of pesticide user decision—making criteria and sources of information; • evaluation of the institutional mechanisms and incentives for modifying the decision process; • study of private sector research decision—making criteria in terms of prospects for innovations and need for direct Federal research or incentive programs; • determination of desirable directions for research in integrated pest management. 3. flew approaches to pesticide control will be Investigated to either cor:’plement or supplement current programs. Planned studies include: • evaluation of crop insurance as a means of reducing pesticides use; • study of the feasibility of using licensed pest control advisors to prescribe pesticides. 4. P. set of studies will be initiated to Improve the efficiency and effectiveness of supply and use control aspects of pesticide re- gulation. These will include: • design of information nanagement and decision—making processes that will serve to focus results of human and environmental monitoring, enforcement, research results, and economic analysis in the regulatory process; • evaluation of risks of less stringent registration requirements to determine a minimum set of data consistent with an acceptable risk level; • evaluation of an industry self—testing program similar to that employed by FDA; • coordination and evaluation of air, water, and other legislation as they relate to program objectives. 35 ------- 5. Alternative futures in which the pesticide programs may be operating over the long run will be studied. The pesticide programs at all levels of government do not operate independently of other aspects of society and the economy. Significant recent changes in food supply and energy availability bring home the fact that a long— term program cannot be designed on the basis of current conditions. As assessment of the potential worlds in which a regulatory program may find itself 10 — 25 years from now is essential to planning a flexible yet meaningful strategy for the future. This study will be initiated for completion by January 1976. 36 ------- |