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Annu. Rev. Entomol. 1975.20:119-131. Downloaded from www.annualreviews.org by Universidade Federal do Amazonas on 04/24/14. For personal use only.
FEDERAL AND STATE
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PESTICIDE REGULATIONS AND LEGISLATION Errett Deck Washington State Department of Agriculture, Olympia, Washington
98504
Responsibility for regulating the distribution and use of pesticides in the United States has been shared by state and federal government agencies. Municipal and local governments have played a minor role. Federal authority has emphasized control over labeling, setting of safe residue tolerances, and evaluation of toxicity and safety. State authority has emphasized control over local distribution, storage, use and application, and disposal. Both authorities have cooperated in surveillance, inspection, and analyses of pesticide products. Since the Federal Environmental Pesticide Control Act of 1972 (PL 92-516) (2) was signed on October 21, 1972, pesticide regulatory programs in the United States have been and are being significantly changed. This Act was adopted as a major amendment to the Federal Insecticide, Fungicide, and Rodenticide Act of 1947. As provided in the bill, Congress intends that the new federal responsibilities delegated
in the Act be phased in over a 4-yr period, with final implementation of all provisions by October 21, 1976. Although there will be major changes in pesticide regulatory programs during this implementation period, the new legislation provides for continuing and expanding cooperative responsibility between federal and state agencies. All states will be required to meet certain minimum standards. However, states will be allowed to have more restrictive standards, and a number of states have implemented legisla tion which contains additional statutory authority not provided for in the federal statute. Past and future phases of these coordinated programs will be discussed in this article.
FEDERAL PESTICIDE LEGISLATION
Federal Insecticide Act The first Federal Insecticide Act (4) was passed in 1910 and was intended primarily to protect the buyer (the farmer) against adulterated or misbranded products. Prior 119
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to 1910, the purchase of agricultural chemicals was on a buyer beware basis. Dra matic changes have taken place since that time in the field of chemical pesticides (previously termed economic poisons). Synthetic organic compounds, such as the chlorinated hydrocarbons, organophosphates, carbamates, and phenoxy herbicides, have been added to the early arsenal of pesticides such as arsenic, fluorine, copper, and sulfur compounds. Both private and publicly financed research have greatly increased the number of pesticides available and widened the scope of their useful ness. During this 64-yr period, federal laws have been broadened to regulate the labeling and interstate distribution of insecticides, rodenticides, nematocides, herbi cides, fungicides, plant growth regulators, defoliants, and desiccants for use by farmers, homeowners, and industry. All of these materials which are intended for preventing, destroying, repelling, or mitigating pests or for the purpose of use as plant regulators, defoliants, or desiccants are defined as pesticides.
Federal Insecticide, Fungicide, and Rodenticide Act 0/1947 (5) This Act added a new concept by placing the burden of proof of acceptability of a product on the manufacturer prior to its being marketed. This Act was oriented to protect the user (the consumer) and the general public from pesticides-some of which were highly toxic and all of which were subject to use limitations as required by labeling. The registrant was required to submit scientific proof of the efficacy and safety of the chemical to accomplish the purpose for which it was to be used when the instructions on the label were followed. The U.S. Department of Agriculture was responsible for the enforcement of this Act until December 2, 1970. The U.S. Environmental Protection Agency was created on that date and the responsibility for enforcement of FIFRA was transferred by Executive Order to the new agency. In 1948, the Food and Drug Administration began to establish safe tolerance levels of pesticide residues in foods. In no case were these tolerances established at a level higher than that necessary to accommodate the registered pesticide use as approved by the U.S. Department of Agriculture.
Miller Amendment In 1954, the "Miller Amendment" to the Federal Food, Drug, and Cosmetic Act (3) formalized what had been an informal cooperative arrangement whereby the USDA registered only pesticide uses which resulted in no residues on raw agricul tural commodities or residues declared safe by the FDA. This amendment required that the pesticide registrant submit data not only to the Department of Agriculture, proving the efficacy and safety of the chemical, but also to the FDA, proving the safety of measurable residues found in the raw agricultural commodity produced following labeled use of the pesticide. In establishing this level of safety, the FDA required a safety factor of over 100 to 1 of any measurable effect of the pesticide in controlled warm-blooded animal tests. Residue tolerance-setting has been compli cated for certain pesticides because of interpretation of the "Delaney Clause" (3) [Section 409 (c) (3) (A) Federal Food, Drug, and Cosmetic Act as Amended] to prohibit food uses of pesticides shown capable of inducing cancer in experimental animals. Although the Delaney Clause does not technically apply to pesticide resi-
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dues, this interpretation leaves no room for judgment in determining a no effect level for a weak carcinogen. FDA inspectors regularly examined samples of food products shipped in inter state commerce in order to detect if there were violations of the residue tolerance amendment. This enforcement program proved a significant deterrent to a grower violating the pesticide label directions because if residues were found above the allowable tolerance levels his crop was subject to seizure and he was subject to prosecution. Beginning in 1961, increased emphasis was placed on longer term public health and ecological effects such as the protection of fish, wildlife, and the environment. The President's Science Advisory Committee, the National Academy of Sciences National Research Council, and various subcommittees were instrumental in re shaping the organization and emphasis of pesticide regulation procedures. A federal interdepartmental agreement was developed in 1964 which gave the Department of Health, Education, and Welfare and the Department of the Interior increased pesticide responsibilities in the areas of health and protection of fish and wildlife. Both the Jensen Report of 1969 (7) (by the National Research Council's Committee on Persistent Pesticides) and the Mrak Report of 1969 (9) (by HEW's Commission on Pesticides) expressed concern about the continued use of persistent pesticides and recommended additional restrictions of pesticide uses deemed to be hazardous by any of the three federal agencies.
Environmental Protection Agency This Agency was created December 2, 1970, by a reorganization plan issued by the President. This action brought together the major environmental control programs of the federal government into a single agency. The pesticide regulatory functions of the Departments of Agriculture, Interior, and Health, Education, and Welfare were transferred to this new agency. These regulatory functions included registra tion of pesticides as required under FIFRA; setting of tolerances as required by the Miller Amendment to the Federal Food, Drug, and Cosmetic Act; and many pesticide research and monitoring programs previously conducted by the three departments. In addition, the EPA assumed the functions of the Federal Water Quality Administration (formerly under the Department of Interior); the National Air Pollution Control Administration (formerly under the Department of Health, Education, and Welfare); and the nuclear radiation controls (formerly under the Atomic Energy Commission). Following the creation of this new agency and the required reorganization and consolidation of functions, there was a need to amend prior legislation covering the transferred responsibilities. Since 1970, major amendments have been passed affect ing water quality, air pollution control, and pesticide regulation responsibilities. Details of the new federal pesticide legislation will be covered in this article. Several specialized areas of pesticide responsibility are retained by other federal agencies.
Food and Drug Administration The Food and Drug Administration still retains the responsibility of monitoring food for humans and feed for animals. In addition, any products violating pesticide
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residue tolerances now established by the EPA are subject to seizure by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.
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Department 0/ Transportation The Department of Transportation has rules and regulations governing the trans portation of pesticides under the Code of Federal Regulations (CFR) Title 49Transportation, Parts 100- 199. revised as of January. 1974. Certain pesticides are classified as Class B poisons and are the pesticides of primary concern to the Department of Transportation. Pesticide products designated by the EPA as highly toxic formulations are generally designated by the DOT as Class B poisons for transportation purposes. All labeling requirements and package specifications, in cluding maximum quantities permitted to be shipped in a single outside container. are listed in the DOT regulations for those commodities classified as Class B poisons. Those pesticides not classified as Class B poisons. and Class B poisons moved intrastate by an intrastate carrier not possessing ICC interstate authority, do not fall under DOT authority.
Federal A viation Administration The Federal Aviation Administration. under the Federal Aviation Regulation. Part 137-Agricultural Aircraft Operations, of January 1. 1966, regulates the dispensing of pesticides by aircraft. Under these regulations, as amended, it is a violation for an aerial applicator to apply any pesticide in a manner inconsistent with the direc tions for use on the federally registered label.
Department 0/ Agriculture The Department of Agriculture, through its Consumer and Marketing Services, Meat and Poultry Inspection Program, monitors meat and poultry products includ ing analyses for possible pesticide residues. In addition to the authority to seize contaminated products. the Department identifies. where possible. the source or origin of the contaminated meat with follow-up inspections in order to prevent further marketing of such products. STATE PESTICIDE LEGISLATION
By 1901. five states had enacted insecticide laws to protect the farmer against adulteration of arsenical and sulfur spray materials. In the 70-yr period since that time. all states have adopted pesticide legislation which requires the registration of pesticide products distributed in their respective states. State pesticide registration laws closely coordinate with federal legislation and include authority for inspection and analysis of pesticide products. Many states have adopted very comprehensive pesticide legislation which covers all areas including the labeling. registration, distribution, storage, transportation, use and application, and disposal of pesticides. Over two thirds of the states have found it necessary to adopt legislation which specifically regulates the use and application of pesticides. This includes the regulation of commercial applicators and
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broad authority to control certain uses of pesticides which have proven hazardous and are classified for restricted use in their states. In addition, some states have found it advisable to implement legislation which requires the licensing of pesticide dealers; the licensing and examination of pesticide dealer managers and pesticide consultants; the restriction of the sale and use of restricted-use pesticides by a permit system or other means; and the regulation and inspection of application equipment and pesticide storage and disposal. Legislation in the various states differs greatly because of a difference in need for regulation, due to differences in agricultural and environmental situations, and because of the independent nature of state government. There is a significant differ ence between the necessary level of pesticide control between the open spaces of Wyoming and Montana and the congested intensive agricultural and urban mix of valleys in California or between certain areas of New York and Alaska. Historically and logically, laws to control the local distribution and the application and use of pesticides were within the realm of inherent state police powers. These responsibili ties are essentially intrastate in nature and can best be handled under state legislative authority. Unfortunately, a number of states-some of them important agricultural states-did not choose to accept responsibility for controlling the use of pesticides within their borders. Congress reacted to this lack of control of pesticide use by some states and in 1972 enacted pesticide legislation which gave the federal government the additional authority to regulate the use and registration of pesticides produced and used solely in intrastate commerce. However, Congress recognized the advan tage of utilizing state expertise and the state's understanding of local problems and made provisions for cooperation between the EPA and state government agencies. While the Federal act preempts municipal and local governments from regulating pesticides, it provides that states may retain important functions in pesticide regula tory programs, such as the certification of applicators, the registration of pesticides for special local needs, the issuance of experimental use permits, and the enforce ment of the act. The need for uniform national standards for pesticide labeling, residue tolerances, and the scientific evaluation of toxicity hazards was obvious. For this reason, states have adopted the residue tolerances as established by federal agencies and almost uniformly have accepted federal labels, at least as far as safety precautions, general format, and standard directions for use. The states provided for special local needs, either by means of state supplemental labeling to accompany federally registered products or by issuing state registrations for labels of products formulated for use within the state. Prior to the implementation of the 1972 federal pesticide amendments, state regulations were the only authority filling an important gap between the federal authority to control the interstate shipment of a federally registered pesticide and the interstate shipment of a food or feed grown from a crop treated with that pesticide. Even with the full enactment of the Federal Environmental Pesticide Control Act of 1972, there are several almost mandatory responsibilities and a number of permissive responsibilities which states should accept to assure an effi cient and effective pesticide control program throughout the United States.
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State government was first to adopt and implement pesticide legislation in this country. There was an early attempt to guide states in adopting, as appropriate, uniform legislation. The Uniform State Insecticide, Fungicide, and Rodenticide Act ( 13) was published by the Council of State Governments in 1946 as a guide to state governments for the registration of pesticides. This proposed state legislation was designed to work in harmony with the Federal Insecticide, Fungicide, and Rodenti cide Act, passed by Congress the following year. The 1946 state act (designated as the "Suggested State Pesticide Control Act") was amended in 1971 and again in 1973 to include provisions for: licensing pesticide dealers; licensing pest manage ment consultants; establishing a pesticide advisory board; adopting regulations to control storage, distribution, and disposal of pesticides; and providing for cooper ative agreements with the EPA or other agencies. The 1973-1974 Official Publica tion of the Association of American Pesticide Control Officials includes the latest draft of the "Suggested State Pesticide Control Act" ( 1 1). During the 194Os, a number of states adopted legislation to control the use and application of pesticides. The Association of American Pesticide Control Officials developed the Model Custom Application of Pesticides Act, which was published as suggested state legislation by the Council of State Governments in 1951. This suggested legislation to regulate use was updated again in 1970, and this Model Pesticide Use and Application Act (8), as adopted by AAPCO and the National Association of State Departments of Agriculture (NASDA), was published in the Council of State Governments' publication entitled, " 1971 Suggested State Legisla tion." In order that this suggested state legislation might closely coordinate with the new Federal Act, which now relates to use, it was again updated in 1973 and the "Suggested State Pesticide Use and Application Act" ( 12) is published in the Coun cil of State Governments' " 1974 Suggested State Legislation" (Volume XXXIII, p. 80). These model pesticide registration and application bills, developed by AAPCO, have helped many states to adopt relatively uniform and effective legisla tion to cover their responsibilities. The Association of American Pesticide Control Officials has been an active orga nization in coordinating state and federal legislation. Members include federal and state officials regulating pesticides, individuals inspecting and analyzing pesticides, and research workers investigating pesticides. Members supported a number of proposals to improve the preliminary drafts of the Federal Act and congressional committees were responsive. The Association's purpose, as filed with the Recorder of Deeds, Washington, D.C., emphasizes the promotion of uniform and effective legislation. Pesticides applied according to label directions have not caused significant health hazards or illness�s. The major problems have resulted from misuse--either from ignorance or by accident. Most pesticide incidents have resulted from misuse in the distribution, storage, transportation, or disposal, or by the misapplication by the ultimate user, whether he be a small private user, a large commercial grower, or a commercial applicator. For this reason, the role of states in education and regulation is important. The full implementation of the new federal regulations will encourage states that have not implemented comprehensive control programs to do so, other-
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wise their agricultural producers may not be able to continue to use certain restrict ed-use pesticides necessary for successful crop production. During the past two years, there has been a flurry of activity in initiating or amending state pesticide legislation. Until the final regulations are adopted by the EPA, it is difficult to determine whether a particular state's authority adequately allows for full participation in all the federal-state programs provided for in the federal act. A number of states have either an effective program which should be acceptable, or broad enough legislative authority that their state-developed regula
Annu. Rev. Entomol. 1975.20:119-131. Downloaded from www.annualreviews.org by Universidade Federal do Amazonas on 04/24/14. For personal use only.
tions should satisfy the EPA regulatory requirements. While approximately
35
states
(1) have some type of regulatory control over
commercial pesticide applicators, very few have broad enough statutory authority to certify private applicators (farmers) and no state has fully implemented such a certification program. Even though the EPA has not completed specific guidelines for state plans and other state responsibilities covered by the federal act, those states with no experience in licensing or certifying applicators should be developing and introducing basic enabling legislation. New programs cannot be effective on a crash basis and the action dates of October
2 1, 1974, 1975,
and
1976
may pass without
successful implementation of all requirements.
FEDERAL ENVIRONMENTAL PESTICIDE CONTROL ACT OF 1972 After two years of intensive study by the House Agriculture Committee, the Senate Agriculture and Forestry Committee, and the Senate Commerce Committee, Con gress enacted PL 92-516, which was a major amendment to the Federal Insecticide,
1947. This bill was signed by President Nixon 21, 1972. Committee members, through input at public hearings and
Fungicide, and Rodenticide Act of on October
volumes of written testimony, considered all affected segments of our society in developing this legislation. There was extensive testimony from environmental groups, chemical industry associations, consumer interest groups, agricultural pro ducer associations, and many governmental agencies, both federal and state. In total, over
15 drafts of this legislation were proposed and evaluated
before the final
draft was submitted by the Joint House/Senate Committee of Conference (Report No.
92-1540) (6). This process required thousands of hours of input and resulted
in the elimination of hundreds of unworkable proposals. Many were submitted by individuals with no experience in enforcing pesticide legislation and with little understanding of the problems their proposals would create for the federal enforcing agency (EPA), cooperating state control officials, agriculture, other users of pesti cides, the chemical industry, and eventually the public welfare. As is true with all compromise legislation involving a controversial issue, no one is completely satisfied with the act. There were many vitally interested groups, some constructive and some polarized on opposite extremes. Some may question the need for certain provisions in the act or the lack of certain authorities, however, at this point such deliberation is academic. The legislation does grant the EPA broad and flexible authority to regulate pesticides in order to provide for the protection of man and his environ-
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ment. The successful implementation of the many provisions in the act will depend upon the responsible development of regulations and enforcement policies by the EPA. The EPA could accomplish the purposes of the act and carry out the intent of Congress without undue interference in the country's ability to control pests or without creating hardship on the producers or users of pesticides.
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Major New Responsibilities 0/ the EPA The Federal Environmental Pesticide Control Act of 1972 increases the responsibil ity and authority of the EPA substantially. Some of the major new provisions are: (a) Regulate the use of all pesticides (some previously covered only by state author ity). (b) Extend Fedenil pesticide regulations to actions entirely within a single state (intrastate registration, distribution, and use). (c) Prohibit the use of any pesticide in a manner inconsistent with its labeling. In Senate Report No. 92-838 (10), the committee indicated that administrative interpretation of this provision should not prohibit a use "which has only beneficial effects on man and his environment.... Further, it is the belief of the Committee that the use of the word 'inconsistent' should be read and administered in a way so as to visit penalties only upon those individuals who have disregarded instructions on a label that would indicate to a man of ordinary intelligence that use not in accordance with such instructions might endanger the safety of others or the environment." (d) Require pesticides and their uses to be classified for general or restricted use (explained below under heading: Classifications of Pesticides and Pesticide Uses). (e) Require the registration of all pesticide-producing establishments (explained below under heading: Registration of Establishments). if) Authorize stop sale, use, or removal orders and provide for civil penalties. While criminal provisions may be used where circumstances warrant, the flexibility of having civil remedies available provides an appropriate means of enforcement without subjecting a person to criminal sanctions. (g) Authorize the establishment of packaging standards and the regulation of pesticide and container disposal. (h) Give applicants for registration proprietary rights in their test data. (i) Authorize cooperation with the states in enforcement, registration of pesticides for special local needs, training and certification of applicators (explained below under heading: Certification of Applicators), research and monitoring, and issuing experimental use permits. Section 2 of Public Law 92-516 contains all the amendments to the Federal Insecticide, Fungicide, and Rodenticide Act. It consists of 27 sections which may be cited as the "Federal Environmental Pesticide Control Act of 1972." The act is now commonly being referred to as "Amended FIFRA." Section 3 of PL 92-516 briefly amends the Federal Hazardous Substances Act, the Poison Prevention Pack aging Act, and the Federal Food, Drug, and Cosmetic Act. Section 4 of PL 92-516 provides the effective dates for implementation of the various provisions of the act. While it was provided that the amendments to FIFRA would take effect at the close of the date of enactment of the act, the exemptions and timing for their implementa tion are very important. All procedures and established regulations which are consistent with the amendments are to remain in force until amended or superseded. New regulations were necessary for implementing some provisions of the act that
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were to become effective on date of enactment. Those regulations were to be promul gated and become effective within 90 days of enactment. This was a difficult require ment and in a number of instances the EPA was not able to comply with the time frame. In order to allow everyone an opportunity to comply with the provisions of the new regulations, no criminal or civil penalties are to be imposed for any act or failure to act until 60 days after the effective regulations have been published in the Federal Register. For the purposes of this article, it is not appropriate that details of implementation of each section of the 27 sections of the amendments be listed. but it is important to outline the annual bench-marks in implementation that are to be met.
Certification 0/ Applicators By October 21 , 1973, the Administrator of the EPA was to have prescribed stan dards for the certification of applicators. The law states that certified applicators are to be individuals who are certified as competent and authorized to use or supervise the use and handling of any pesticide classified for restricted use. This certification is to be accomplished by states who are approved by the Administrator to implement this function under an approved state plan. The complexity of establishing these standards and the considerable controversy over how specific, comprehensive, or restrictive the standards should be resulted in delay. The proposed regulation was not published in the Federal Register until February 22, 1974. There was tremen dous input from all interested and affected persons in the development of these proposed regulations and the final regulations should be adopted by June 1974. These regulations can serve as a guide for states in developing their state plan and in developing and testing programs for certifying applicators to cover the require ments of the federal act. By October 1, 1975, each state that desires to certify applicators must submit a state plan indicating how it proposes to accomplish this responsibility. Regulations or guidelines for these state plans (developed at regional meetings between state control officials and the EPA staff ) are now being prepared for publication in the Federal Register. By October 21. 1 976. states must have certification plans in operation in order that commercial or private applicators may use pesticides which are restricted for use only by certified applicators. At this time. the EPA has no plans to set up a federal applicator certification program and indeed the federal act does not prescribe a mechanism for setting up such a program. According to the EPA the availability of restricted use pesticides in a state for its legitimate users could depend upon the success of a state in submitting. getting approved, and implementing a state plan for certifying applicators.
Registration 0/ Establishments The act required that. by October 21, 1973, the EPA promulgate effective regula tions relating to the registration of establishments. On November 6, 1973, the EPA published adopted regulations regarding the registration of pesticide-producing es-
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tablishments and the submission of pesticide reports and labeling by the pesticide producer. Under this legislation, an establishment is a location in which any pesti cide subject to the act is produced. Under this establishment registration require ment, the producer who operates the establishment must apply for registration and must inform the EPA of the types and amounts of pesticides he is currently produc ing, the amount he produced during the past year, and the type and amount he has old or distributed during the past year. After the initial registration application, the producer is required to keep a current record and submit this record annually to the Administrator of the EPA. The timetable as developed in the regulations re quires registration by December 24, 1973, of all establishments producing pesticides distributed in interstate commerce and by October 21, 1974, for all establishments producing pesticides solely for intrastate commerce. Each location will be assigned an establishment registration number and that number must appear on the container or label of each pesticide product produced at that location.
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�
Classification of Pesticides and Pesticide Uses Two years after enactment of the act, the EPA must have final regulations adopted which provide for the classification of pesticide uses. After that time all new applica tions for registration must be classified either restricted use or general use. Between October 21, 1974 and October 21, 1976 all prior registered pesticide uses will have to be reclassified and designated as either restricted or general use pesticides. The federal act provides that: (B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environ ment, he will classify the pesticide or the particular use or uses of the pesticide to which the determination applies, for general use.
In the same manner, the federal act provides that: (C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, may generally cause, without additional regulatory restrictions, un reasonable adverse effects on the environment, including injury to the applicator, he shall classify the pesticide, or the particular use or uses to which the determination applies, for restricted use.
These two very general definitions leave considerable flexibility for judgment. The standards developed to implement this requirement are of critical importance to the federal scheme. Many of the regulatory provisions of the act hinge on the classifica tion scheme. For many years, the basic consideration for safety in pesticide use was "Before Using Any Pesticide-STOP-Read the Label-Follow Label Directions." Because of the comprehensive requirements that must be met before a pesticide use and its labeling can be registered, there have been few incidents of illegal residues on food crops and few illnesses of users and the public when labeling directions and
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precautions have been followed. Those uses which present a special hazard to the applicator or the environment, for which labeling restrictions are not sufficient protection, can be further regulated by the restricted use concept. An example would be sodium fiuoroacetate (compound 1080), an effective but hazardous rodenticide which has been strictly regulated because of its high toxicity and potential for secondary poisoning. Within the restricted use classification there will be those pesticide uses which, because of acute dermal or inhalation toxicity, present a hazard to the applicator and for that reason may be applied only by or under the direct supervision of a certified applicator. Other pesticides or pesticide uses may cause unreasonable adverse effects on the environment. These pesticides or pesticide uses may be re stricted to use by, or under the direct supervision of, a certified applicator, or may be subject to other restrictions as provided by the EPA regulations. The final date for requiring the classification of all pesticides and their uses as general use or restricted use and for the certification of those persons who need to apply restricted use pesticides is coordinated in the one date for full implementation of the act-October 21, 1976.
Registrations for Special Local Needs After October 21, 1974, not only must all new pesticide registrations be classified as general or restricted use, but all intrastate pesticides must be registered under provisions of the act. The Conference Report No. 92-1540, page 33, point (47), clarifies the issue of the validity of state registrations of pesticides which are distrib uted only in intrastate commerce: "Section 4(c)(l ) of this bill gives the Administra tor up to two years to promulgate regulations providing for registration of pesticides under provisions of H.R. 10729. This provision of section 4(d) makes it clear that state registered pesticides moving only in intrastate commerce would be provided an opportunity to register under the federal law before their distribution would be prohibited. " Section 24(c) of the act provides for states to continue to register pesticides for special local needs. A copy of the subsection follows : Sec. 24.(c) A Stat e may provide registration for pesticides fonnulated for distribution and use within that State to meet special local needs if that State is certified by the Administrator as capable of exercising adequate controls to assure that such registration will be in accord with the purposes of this Act and if registration for such use has not previously been denied, disapproved, or canceled by the Administrator. Such registration shall be deemed registration under Section 3 for all purposes of this Act, but shall authorize distribution and use only within such State and shall not be effective for more than 90 days if disapproved by the Administrator within that period.
The EPA regulations setting standards for these registrations must be published with a dequate lead time so that states can be certified well in advance of October 21, 1974. States will be able to assist the EPA in the registration of these locally formulated products for local or minor uses, pesticide-fertilizer mixes, or special package mixes. Other special local needs include supplemental labeling to accoml
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pany a product. This labeling may contain minor changes or additions to directions for use which will accommodate special situations but which are within the scope of federally approved uses. The Congressional intent is expressed in Senate Report No. 92-838: "The purpose of this subsection is to give a State the opportunity to meet expeditiously and with less cost and administrative burden on the registrant the problem of registering for local use a pesticide needed to treat a pest infestation which is a problem in such State but is not sufficiently widespread to warrant the expense and difficulties of Federal registration."
SUMMARY The combined research, education, and regulatory efforts of federal and state gov ernments have made possible an impressive record of abundant production while imposing minimal harm to human health and the environment. Considering that approximately one billion pounds of pesticides are being applied in the United States annually to control about 2000 pest species, the safety record is remarkable. The increased public concern about environmental values and long-term health effects is constructive and is resulting in some of the regulatory changes discussed in this article. The Federal Environmental Pesticide Control Act can result in an improved and expanded joint effort by federal and state governments to limit the misuse of pesticides while permitting their use to facilitate increased production of food, feed, and fiber; provide protection from spoilage; improve health; and control nuisance insects and unwanted plants. Implementation of current regulations, plus those in the process of being enacted under authority of the new federal act, will be complex and costly. Regulations will control the registration, labeling, distribution, storage, use and application, and disposal of pesticides. A small segment of our society would like to have the use of all chemicals banned. A few individuals oppose all government controls. However, the vast majority of agricultural producer groups, representatives of industry, and the public support the need for pesticide regulations. Only through continued legal controls over pesticides may we hope to retain their use. Our society has gained tremendous benefits from the use of pesticides to prevent disease and to increase the production of food and fiber. Our need to use pesticides will continue to increase for the foreseeable future. Government agencies responsible for protecting human health and the environment must make sound judgments on an individual basis in evaluating the evidence concerning both the benefits and risks of using pesticides.
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Literature Cited
1. Baker, E. R. 1973. Digest ofState Pesti cide Use and Application Laws. EPA Operations Division. l a-55j 2. Federal Environmental Pesticide Con trol Act of 1972. Public Law 92-516. Amendment to Federal Insecticide, Fungicide, and'Rodenticide Act of 1947 3. Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, 21 U.S.c. 301 et/seq. 1938. Miller Amendment, 68 Stat. 511; 21 U.S.c. 346a. 1954. As amended 1958. Delaney Clause, 21 U.S.C. 348(c)(3)(A) 4. Federal Insecticide Act, 36 Stat. 335; 7 U.S.C. 121. 1910 5. Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 135-135K. 1947 6. House of Representatives Conference Report No. 92-1540. October 5, 1972. Federal Environmental Pesticide Con trol Act 7. Jensen, J. H. 1969. Report of Committee on Persistent Pesticides of the National Research Council's Division 0/ Biology
and Agriculture, 1-34 8. Model Pesticide Use and Application Act. 1971. Council of State Govern ment's Suggested State Legislation. 1971. 30:185-200 9. Mrak, E. M. 1969. Report of the Secre
tary's Commission on Pesticides and Their Relationship to Environmental Health U.S. Dep. Health, Education
and Welfare 10. Senate Report No. 92-838. June 7, 1972. Report to Accompany H.R. 10729. 16 . II. Suggested State Pesticide Control Act. 1973. The 1973-74 Official Publication of the Association of American Pesti cide Control Officials, 20-39 12. Suggested State Pesticide Use and Ap plication Act. 1973. Council of State Government's Suggested State Legisla tion. 1974. 33:80-100 13. Uniform State Insecticide, Fungicide, and Rodenticide Act. 1946. Council of State Government's Suggested State Legislation, Program for 1947. 1946. A89-109
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FEDERAL AND STATE
+6083
PESTICIDE REGULATIONS AND LEGISLATION Errett Deck Washington State Department of Agriculture, Olympia, Washington
98504
Responsibility for regulating the distribution and use of pesticides in the United States has been shared by state and federal government agencies. Municipal and local governments have played a minor role. Federal authority has emphasized control over labeling, setting of safe residue tolerances, and evaluation of toxicity and safety. State authority has emphasized control over local distribution, storage, use and application, and disposal. Both authorities have cooperated in surveillance, inspection, and analyses of pesticide products. Since the Federal Environmental Pesticide Control Act of 1972 (PL 92-516) (2) was signed on October 21, 1972, pesticide regulatory programs in the United States have been and are being significantly changed. This Act was adopted as a major amendment to the Federal Insecticide, Fungicide, and Rodenticide Act of 1947. As provided in the bill, Congress intends that the new federal responsibilities delegated
in the Act be phased in over a 4-yr period, with final implementation of all provisions by October 21, 1976. Although there will be major changes in pesticide regulatory programs during this implementation period, the new legislation provides for continuing and expanding cooperative responsibility between federal and state agencies. All states will be required to meet certain minimum standards. However, states will be allowed to have more restrictive standards, and a number of states have implemented legisla tion which contains additional statutory authority not provided for in the federal statute. Past and future phases of these coordinated programs will be discussed in this article.
FEDERAL PESTICIDE LEGISLATION
Federal Insecticide Act The first Federal Insecticide Act (4) was passed in 1910 and was intended primarily to protect the buyer (the farmer) against adulterated or misbranded products. Prior 119
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to 1910, the purchase of agricultural chemicals was on a buyer beware basis. Dra matic changes have taken place since that time in the field of chemical pesticides (previously termed economic poisons). Synthetic organic compounds, such as the chlorinated hydrocarbons, organophosphates, carbamates, and phenoxy herbicides, have been added to the early arsenal of pesticides such as arsenic, fluorine, copper, and sulfur compounds. Both private and publicly financed research have greatly increased the number of pesticides available and widened the scope of their useful ness. During this 64-yr period, federal laws have been broadened to regulate the labeling and interstate distribution of insecticides, rodenticides, nematocides, herbi cides, fungicides, plant growth regulators, defoliants, and desiccants for use by farmers, homeowners, and industry. All of these materials which are intended for preventing, destroying, repelling, or mitigating pests or for the purpose of use as plant regulators, defoliants, or desiccants are defined as pesticides.
Federal Insecticide, Fungicide, and Rodenticide Act 0/1947 (5) This Act added a new concept by placing the burden of proof of acceptability of a product on the manufacturer prior to its being marketed. This Act was oriented to protect the user (the consumer) and the general public from pesticides-some of which were highly toxic and all of which were subject to use limitations as required by labeling. The registrant was required to submit scientific proof of the efficacy and safety of the chemical to accomplish the purpose for which it was to be used when the instructions on the label were followed. The U.S. Department of Agriculture was responsible for the enforcement of this Act until December 2, 1970. The U.S. Environmental Protection Agency was created on that date and the responsibility for enforcement of FIFRA was transferred by Executive Order to the new agency. In 1948, the Food and Drug Administration began to establish safe tolerance levels of pesticide residues in foods. In no case were these tolerances established at a level higher than that necessary to accommodate the registered pesticide use as approved by the U.S. Department of Agriculture.
Miller Amendment In 1954, the "Miller Amendment" to the Federal Food, Drug, and Cosmetic Act (3) formalized what had been an informal cooperative arrangement whereby the USDA registered only pesticide uses which resulted in no residues on raw agricul tural commodities or residues declared safe by the FDA. This amendment required that the pesticide registrant submit data not only to the Department of Agriculture, proving the efficacy and safety of the chemical, but also to the FDA, proving the safety of measurable residues found in the raw agricultural commodity produced following labeled use of the pesticide. In establishing this level of safety, the FDA required a safety factor of over 100 to 1 of any measurable effect of the pesticide in controlled warm-blooded animal tests. Residue tolerance-setting has been compli cated for certain pesticides because of interpretation of the "Delaney Clause" (3) [Section 409 (c) (3) (A) Federal Food, Drug, and Cosmetic Act as Amended] to prohibit food uses of pesticides shown capable of inducing cancer in experimental animals. Although the Delaney Clause does not technically apply to pesticide resi-
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dues, this interpretation leaves no room for judgment in determining a no effect level for a weak carcinogen. FDA inspectors regularly examined samples of food products shipped in inter state commerce in order to detect if there were violations of the residue tolerance amendment. This enforcement program proved a significant deterrent to a grower violating the pesticide label directions because if residues were found above the allowable tolerance levels his crop was subject to seizure and he was subject to prosecution. Beginning in 1961, increased emphasis was placed on longer term public health and ecological effects such as the protection of fish, wildlife, and the environment. The President's Science Advisory Committee, the National Academy of Sciences National Research Council, and various subcommittees were instrumental in re shaping the organization and emphasis of pesticide regulation procedures. A federal interdepartmental agreement was developed in 1964 which gave the Department of Health, Education, and Welfare and the Department of the Interior increased pesticide responsibilities in the areas of health and protection of fish and wildlife. Both the Jensen Report of 1969 (7) (by the National Research Council's Committee on Persistent Pesticides) and the Mrak Report of 1969 (9) (by HEW's Commission on Pesticides) expressed concern about the continued use of persistent pesticides and recommended additional restrictions of pesticide uses deemed to be hazardous by any of the three federal agencies.
Environmental Protection Agency This Agency was created December 2, 1970, by a reorganization plan issued by the President. This action brought together the major environmental control programs of the federal government into a single agency. The pesticide regulatory functions of the Departments of Agriculture, Interior, and Health, Education, and Welfare were transferred to this new agency. These regulatory functions included registra tion of pesticides as required under FIFRA; setting of tolerances as required by the Miller Amendment to the Federal Food, Drug, and Cosmetic Act; and many pesticide research and monitoring programs previously conducted by the three departments. In addition, the EPA assumed the functions of the Federal Water Quality Administration (formerly under the Department of Interior); the National Air Pollution Control Administration (formerly under the Department of Health, Education, and Welfare); and the nuclear radiation controls (formerly under the Atomic Energy Commission). Following the creation of this new agency and the required reorganization and consolidation of functions, there was a need to amend prior legislation covering the transferred responsibilities. Since 1970, major amendments have been passed affect ing water quality, air pollution control, and pesticide regulation responsibilities. Details of the new federal pesticide legislation will be covered in this article. Several specialized areas of pesticide responsibility are retained by other federal agencies.
Food and Drug Administration The Food and Drug Administration still retains the responsibility of monitoring food for humans and feed for animals. In addition, any products violating pesticide
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residue tolerances now established by the EPA are subject to seizure by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.
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Department 0/ Transportation The Department of Transportation has rules and regulations governing the trans portation of pesticides under the Code of Federal Regulations (CFR) Title 49Transportation, Parts 100- 199. revised as of January. 1974. Certain pesticides are classified as Class B poisons and are the pesticides of primary concern to the Department of Transportation. Pesticide products designated by the EPA as highly toxic formulations are generally designated by the DOT as Class B poisons for transportation purposes. All labeling requirements and package specifications, in cluding maximum quantities permitted to be shipped in a single outside container. are listed in the DOT regulations for those commodities classified as Class B poisons. Those pesticides not classified as Class B poisons. and Class B poisons moved intrastate by an intrastate carrier not possessing ICC interstate authority, do not fall under DOT authority.
Federal A viation Administration The Federal Aviation Administration. under the Federal Aviation Regulation. Part 137-Agricultural Aircraft Operations, of January 1. 1966, regulates the dispensing of pesticides by aircraft. Under these regulations, as amended, it is a violation for an aerial applicator to apply any pesticide in a manner inconsistent with the direc tions for use on the federally registered label.
Department 0/ Agriculture The Department of Agriculture, through its Consumer and Marketing Services, Meat and Poultry Inspection Program, monitors meat and poultry products includ ing analyses for possible pesticide residues. In addition to the authority to seize contaminated products. the Department identifies. where possible. the source or origin of the contaminated meat with follow-up inspections in order to prevent further marketing of such products. STATE PESTICIDE LEGISLATION
By 1901. five states had enacted insecticide laws to protect the farmer against adulteration of arsenical and sulfur spray materials. In the 70-yr period since that time. all states have adopted pesticide legislation which requires the registration of pesticide products distributed in their respective states. State pesticide registration laws closely coordinate with federal legislation and include authority for inspection and analysis of pesticide products. Many states have adopted very comprehensive pesticide legislation which covers all areas including the labeling. registration, distribution, storage, transportation, use and application, and disposal of pesticides. Over two thirds of the states have found it necessary to adopt legislation which specifically regulates the use and application of pesticides. This includes the regulation of commercial applicators and
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broad authority to control certain uses of pesticides which have proven hazardous and are classified for restricted use in their states. In addition, some states have found it advisable to implement legislation which requires the licensing of pesticide dealers; the licensing and examination of pesticide dealer managers and pesticide consultants; the restriction of the sale and use of restricted-use pesticides by a permit system or other means; and the regulation and inspection of application equipment and pesticide storage and disposal. Legislation in the various states differs greatly because of a difference in need for regulation, due to differences in agricultural and environmental situations, and because of the independent nature of state government. There is a significant differ ence between the necessary level of pesticide control between the open spaces of Wyoming and Montana and the congested intensive agricultural and urban mix of valleys in California or between certain areas of New York and Alaska. Historically and logically, laws to control the local distribution and the application and use of pesticides were within the realm of inherent state police powers. These responsibili ties are essentially intrastate in nature and can best be handled under state legislative authority. Unfortunately, a number of states-some of them important agricultural states-did not choose to accept responsibility for controlling the use of pesticides within their borders. Congress reacted to this lack of control of pesticide use by some states and in 1972 enacted pesticide legislation which gave the federal government the additional authority to regulate the use and registration of pesticides produced and used solely in intrastate commerce. However, Congress recognized the advan tage of utilizing state expertise and the state's understanding of local problems and made provisions for cooperation between the EPA and state government agencies. While the Federal act preempts municipal and local governments from regulating pesticides, it provides that states may retain important functions in pesticide regula tory programs, such as the certification of applicators, the registration of pesticides for special local needs, the issuance of experimental use permits, and the enforce ment of the act. The need for uniform national standards for pesticide labeling, residue tolerances, and the scientific evaluation of toxicity hazards was obvious. For this reason, states have adopted the residue tolerances as established by federal agencies and almost uniformly have accepted federal labels, at least as far as safety precautions, general format, and standard directions for use. The states provided for special local needs, either by means of state supplemental labeling to accompany federally registered products or by issuing state registrations for labels of products formulated for use within the state. Prior to the implementation of the 1972 federal pesticide amendments, state regulations were the only authority filling an important gap between the federal authority to control the interstate shipment of a federally registered pesticide and the interstate shipment of a food or feed grown from a crop treated with that pesticide. Even with the full enactment of the Federal Environmental Pesticide Control Act of 1972, there are several almost mandatory responsibilities and a number of permissive responsibilities which states should accept to assure an effi cient and effective pesticide control program throughout the United States.
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State government was first to adopt and implement pesticide legislation in this country. There was an early attempt to guide states in adopting, as appropriate, uniform legislation. The Uniform State Insecticide, Fungicide, and Rodenticide Act ( 13) was published by the Council of State Governments in 1946 as a guide to state governments for the registration of pesticides. This proposed state legislation was designed to work in harmony with the Federal Insecticide, Fungicide, and Rodenti cide Act, passed by Congress the following year. The 1946 state act (designated as the "Suggested State Pesticide Control Act") was amended in 1971 and again in 1973 to include provisions for: licensing pesticide dealers; licensing pest manage ment consultants; establishing a pesticide advisory board; adopting regulations to control storage, distribution, and disposal of pesticides; and providing for cooper ative agreements with the EPA or other agencies. The 1973-1974 Official Publica tion of the Association of American Pesticide Control Officials includes the latest draft of the "Suggested State Pesticide Control Act" ( 1 1). During the 194Os, a number of states adopted legislation to control the use and application of pesticides. The Association of American Pesticide Control Officials developed the Model Custom Application of Pesticides Act, which was published as suggested state legislation by the Council of State Governments in 1951. This suggested legislation to regulate use was updated again in 1970, and this Model Pesticide Use and Application Act (8), as adopted by AAPCO and the National Association of State Departments of Agriculture (NASDA), was published in the Council of State Governments' publication entitled, " 1971 Suggested State Legisla tion." In order that this suggested state legislation might closely coordinate with the new Federal Act, which now relates to use, it was again updated in 1973 and the "Suggested State Pesticide Use and Application Act" ( 12) is published in the Coun cil of State Governments' " 1974 Suggested State Legislation" (Volume XXXIII, p. 80). These model pesticide registration and application bills, developed by AAPCO, have helped many states to adopt relatively uniform and effective legisla tion to cover their responsibilities. The Association of American Pesticide Control Officials has been an active orga nization in coordinating state and federal legislation. Members include federal and state officials regulating pesticides, individuals inspecting and analyzing pesticides, and research workers investigating pesticides. Members supported a number of proposals to improve the preliminary drafts of the Federal Act and congressional committees were responsive. The Association's purpose, as filed with the Recorder of Deeds, Washington, D.C., emphasizes the promotion of uniform and effective legislation. Pesticides applied according to label directions have not caused significant health hazards or illness�s. The major problems have resulted from misuse--either from ignorance or by accident. Most pesticide incidents have resulted from misuse in the distribution, storage, transportation, or disposal, or by the misapplication by the ultimate user, whether he be a small private user, a large commercial grower, or a commercial applicator. For this reason, the role of states in education and regulation is important. The full implementation of the new federal regulations will encourage states that have not implemented comprehensive control programs to do so, other-
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wise their agricultural producers may not be able to continue to use certain restrict ed-use pesticides necessary for successful crop production. During the past two years, there has been a flurry of activity in initiating or amending state pesticide legislation. Until the final regulations are adopted by the EPA, it is difficult to determine whether a particular state's authority adequately allows for full participation in all the federal-state programs provided for in the federal act. A number of states have either an effective program which should be acceptable, or broad enough legislative authority that their state-developed regula
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tions should satisfy the EPA regulatory requirements. While approximately
35
states
(1) have some type of regulatory control over
commercial pesticide applicators, very few have broad enough statutory authority to certify private applicators (farmers) and no state has fully implemented such a certification program. Even though the EPA has not completed specific guidelines for state plans and other state responsibilities covered by the federal act, those states with no experience in licensing or certifying applicators should be developing and introducing basic enabling legislation. New programs cannot be effective on a crash basis and the action dates of October
2 1, 1974, 1975,
and
1976
may pass without
successful implementation of all requirements.
FEDERAL ENVIRONMENTAL PESTICIDE CONTROL ACT OF 1972 After two years of intensive study by the House Agriculture Committee, the Senate Agriculture and Forestry Committee, and the Senate Commerce Committee, Con gress enacted PL 92-516, which was a major amendment to the Federal Insecticide,
1947. This bill was signed by President Nixon 21, 1972. Committee members, through input at public hearings and
Fungicide, and Rodenticide Act of on October
volumes of written testimony, considered all affected segments of our society in developing this legislation. There was extensive testimony from environmental groups, chemical industry associations, consumer interest groups, agricultural pro ducer associations, and many governmental agencies, both federal and state. In total, over
15 drafts of this legislation were proposed and evaluated
before the final
draft was submitted by the Joint House/Senate Committee of Conference (Report No.
92-1540) (6). This process required thousands of hours of input and resulted
in the elimination of hundreds of unworkable proposals. Many were submitted by individuals with no experience in enforcing pesticide legislation and with little understanding of the problems their proposals would create for the federal enforcing agency (EPA), cooperating state control officials, agriculture, other users of pesti cides, the chemical industry, and eventually the public welfare. As is true with all compromise legislation involving a controversial issue, no one is completely satisfied with the act. There were many vitally interested groups, some constructive and some polarized on opposite extremes. Some may question the need for certain provisions in the act or the lack of certain authorities, however, at this point such deliberation is academic. The legislation does grant the EPA broad and flexible authority to regulate pesticides in order to provide for the protection of man and his environ-
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ment. The successful implementation of the many provisions in the act will depend upon the responsible development of regulations and enforcement policies by the EPA. The EPA could accomplish the purposes of the act and carry out the intent of Congress without undue interference in the country's ability to control pests or without creating hardship on the producers or users of pesticides.
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Major New Responsibilities 0/ the EPA The Federal Environmental Pesticide Control Act of 1972 increases the responsibil ity and authority of the EPA substantially. Some of the major new provisions are: (a) Regulate the use of all pesticides (some previously covered only by state author ity). (b) Extend Fedenil pesticide regulations to actions entirely within a single state (intrastate registration, distribution, and use). (c) Prohibit the use of any pesticide in a manner inconsistent with its labeling. In Senate Report No. 92-838 (10), the committee indicated that administrative interpretation of this provision should not prohibit a use "which has only beneficial effects on man and his environment.... Further, it is the belief of the Committee that the use of the word 'inconsistent' should be read and administered in a way so as to visit penalties only upon those individuals who have disregarded instructions on a label that would indicate to a man of ordinary intelligence that use not in accordance with such instructions might endanger the safety of others or the environment." (d) Require pesticides and their uses to be classified for general or restricted use (explained below under heading: Classifications of Pesticides and Pesticide Uses). (e) Require the registration of all pesticide-producing establishments (explained below under heading: Registration of Establishments). if) Authorize stop sale, use, or removal orders and provide for civil penalties. While criminal provisions may be used where circumstances warrant, the flexibility of having civil remedies available provides an appropriate means of enforcement without subjecting a person to criminal sanctions. (g) Authorize the establishment of packaging standards and the regulation of pesticide and container disposal. (h) Give applicants for registration proprietary rights in their test data. (i) Authorize cooperation with the states in enforcement, registration of pesticides for special local needs, training and certification of applicators (explained below under heading: Certification of Applicators), research and monitoring, and issuing experimental use permits. Section 2 of Public Law 92-516 contains all the amendments to the Federal Insecticide, Fungicide, and Rodenticide Act. It consists of 27 sections which may be cited as the "Federal Environmental Pesticide Control Act of 1972." The act is now commonly being referred to as "Amended FIFRA." Section 3 of PL 92-516 briefly amends the Federal Hazardous Substances Act, the Poison Prevention Pack aging Act, and the Federal Food, Drug, and Cosmetic Act. Section 4 of PL 92-516 provides the effective dates for implementation of the various provisions of the act. While it was provided that the amendments to FIFRA would take effect at the close of the date of enactment of the act, the exemptions and timing for their implementa tion are very important. All procedures and established regulations which are consistent with the amendments are to remain in force until amended or superseded. New regulations were necessary for implementing some provisions of the act that
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were to become effective on date of enactment. Those regulations were to be promul gated and become effective within 90 days of enactment. This was a difficult require ment and in a number of instances the EPA was not able to comply with the time frame. In order to allow everyone an opportunity to comply with the provisions of the new regulations, no criminal or civil penalties are to be imposed for any act or failure to act until 60 days after the effective regulations have been published in the Federal Register. For the purposes of this article, it is not appropriate that details of implementation of each section of the 27 sections of the amendments be listed. but it is important to outline the annual bench-marks in implementation that are to be met.
Certification 0/ Applicators By October 21 , 1973, the Administrator of the EPA was to have prescribed stan dards for the certification of applicators. The law states that certified applicators are to be individuals who are certified as competent and authorized to use or supervise the use and handling of any pesticide classified for restricted use. This certification is to be accomplished by states who are approved by the Administrator to implement this function under an approved state plan. The complexity of establishing these standards and the considerable controversy over how specific, comprehensive, or restrictive the standards should be resulted in delay. The proposed regulation was not published in the Federal Register until February 22, 1974. There was tremen dous input from all interested and affected persons in the development of these proposed regulations and the final regulations should be adopted by June 1974. These regulations can serve as a guide for states in developing their state plan and in developing and testing programs for certifying applicators to cover the require ments of the federal act. By October 1, 1975, each state that desires to certify applicators must submit a state plan indicating how it proposes to accomplish this responsibility. Regulations or guidelines for these state plans (developed at regional meetings between state control officials and the EPA staff ) are now being prepared for publication in the Federal Register. By October 21. 1 976. states must have certification plans in operation in order that commercial or private applicators may use pesticides which are restricted for use only by certified applicators. At this time. the EPA has no plans to set up a federal applicator certification program and indeed the federal act does not prescribe a mechanism for setting up such a program. According to the EPA the availability of restricted use pesticides in a state for its legitimate users could depend upon the success of a state in submitting. getting approved, and implementing a state plan for certifying applicators.
Registration 0/ Establishments The act required that. by October 21, 1973, the EPA promulgate effective regula tions relating to the registration of establishments. On November 6, 1973, the EPA published adopted regulations regarding the registration of pesticide-producing es-
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tablishments and the submission of pesticide reports and labeling by the pesticide producer. Under this legislation, an establishment is a location in which any pesti cide subject to the act is produced. Under this establishment registration require ment, the producer who operates the establishment must apply for registration and must inform the EPA of the types and amounts of pesticides he is currently produc ing, the amount he produced during the past year, and the type and amount he has old or distributed during the past year. After the initial registration application, the producer is required to keep a current record and submit this record annually to the Administrator of the EPA. The timetable as developed in the regulations re quires registration by December 24, 1973, of all establishments producing pesticides distributed in interstate commerce and by October 21, 1974, for all establishments producing pesticides solely for intrastate commerce. Each location will be assigned an establishment registration number and that number must appear on the container or label of each pesticide product produced at that location.
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�
Classification of Pesticides and Pesticide Uses Two years after enactment of the act, the EPA must have final regulations adopted which provide for the classification of pesticide uses. After that time all new applica tions for registration must be classified either restricted use or general use. Between October 21, 1974 and October 21, 1976 all prior registered pesticide uses will have to be reclassified and designated as either restricted or general use pesticides. The federal act provides that: (B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environ ment, he will classify the pesticide or the particular use or uses of the pesticide to which the determination applies, for general use.
In the same manner, the federal act provides that: (C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, may generally cause, without additional regulatory restrictions, un reasonable adverse effects on the environment, including injury to the applicator, he shall classify the pesticide, or the particular use or uses to which the determination applies, for restricted use.
These two very general definitions leave considerable flexibility for judgment. The standards developed to implement this requirement are of critical importance to the federal scheme. Many of the regulatory provisions of the act hinge on the classifica tion scheme. For many years, the basic consideration for safety in pesticide use was "Before Using Any Pesticide-STOP-Read the Label-Follow Label Directions." Because of the comprehensive requirements that must be met before a pesticide use and its labeling can be registered, there have been few incidents of illegal residues on food crops and few illnesses of users and the public when labeling directions and
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precautions have been followed. Those uses which present a special hazard to the applicator or the environment, for which labeling restrictions are not sufficient protection, can be further regulated by the restricted use concept. An example would be sodium fiuoroacetate (compound 1080), an effective but hazardous rodenticide which has been strictly regulated because of its high toxicity and potential for secondary poisoning. Within the restricted use classification there will be those pesticide uses which, because of acute dermal or inhalation toxicity, present a hazard to the applicator and for that reason may be applied only by or under the direct supervision of a certified applicator. Other pesticides or pesticide uses may cause unreasonable adverse effects on the environment. These pesticides or pesticide uses may be re stricted to use by, or under the direct supervision of, a certified applicator, or may be subject to other restrictions as provided by the EPA regulations. The final date for requiring the classification of all pesticides and their uses as general use or restricted use and for the certification of those persons who need to apply restricted use pesticides is coordinated in the one date for full implementation of the act-October 21, 1976.
Registrations for Special Local Needs After October 21, 1974, not only must all new pesticide registrations be classified as general or restricted use, but all intrastate pesticides must be registered under provisions of the act. The Conference Report No. 92-1540, page 33, point (47), clarifies the issue of the validity of state registrations of pesticides which are distrib uted only in intrastate commerce: "Section 4(c)(l ) of this bill gives the Administra tor up to two years to promulgate regulations providing for registration of pesticides under provisions of H.R. 10729. This provision of section 4(d) makes it clear that state registered pesticides moving only in intrastate commerce would be provided an opportunity to register under the federal law before their distribution would be prohibited. " Section 24(c) of the act provides for states to continue to register pesticides for special local needs. A copy of the subsection follows : Sec. 24.(c) A Stat e may provide registration for pesticides fonnulated for distribution and use within that State to meet special local needs if that State is certified by the Administrator as capable of exercising adequate controls to assure that such registration will be in accord with the purposes of this Act and if registration for such use has not previously been denied, disapproved, or canceled by the Administrator. Such registration shall be deemed registration under Section 3 for all purposes of this Act, but shall authorize distribution and use only within such State and shall not be effective for more than 90 days if disapproved by the Administrator within that period.
The EPA regulations setting standards for these registrations must be published with a dequate lead time so that states can be certified well in advance of October 21, 1974. States will be able to assist the EPA in the registration of these locally formulated products for local or minor uses, pesticide-fertilizer mixes, or special package mixes. Other special local needs include supplemental labeling to accoml
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pany a product. This labeling may contain minor changes or additions to directions for use which will accommodate special situations but which are within the scope of federally approved uses. The Congressional intent is expressed in Senate Report No. 92-838: "The purpose of this subsection is to give a State the opportunity to meet expeditiously and with less cost and administrative burden on the registrant the problem of registering for local use a pesticide needed to treat a pest infestation which is a problem in such State but is not sufficiently widespread to warrant the expense and difficulties of Federal registration."
SUMMARY The combined research, education, and regulatory efforts of federal and state gov ernments have made possible an impressive record of abundant production while imposing minimal harm to human health and the environment. Considering that approximately one billion pounds of pesticides are being applied in the United States annually to control about 2000 pest species, the safety record is remarkable. The increased public concern about environmental values and long-term health effects is constructive and is resulting in some of the regulatory changes discussed in this article. The Federal Environmental Pesticide Control Act can result in an improved and expanded joint effort by federal and state governments to limit the misuse of pesticides while permitting their use to facilitate increased production of food, feed, and fiber; provide protection from spoilage; improve health; and control nuisance insects and unwanted plants. Implementation of current regulations, plus those in the process of being enacted under authority of the new federal act, will be complex and costly. Regulations will control the registration, labeling, distribution, storage, use and application, and disposal of pesticides. A small segment of our society would like to have the use of all chemicals banned. A few individuals oppose all government controls. However, the vast majority of agricultural producer groups, representatives of industry, and the public support the need for pesticide regulations. Only through continued legal controls over pesticides may we hope to retain their use. Our society has gained tremendous benefits from the use of pesticides to prevent disease and to increase the production of food and fiber. Our need to use pesticides will continue to increase for the foreseeable future. Government agencies responsible for protecting human health and the environment must make sound judgments on an individual basis in evaluating the evidence concerning both the benefits and risks of using pesticides.
PESTICIDE REGULATIONS AND LEGISLATION
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Literature Cited
1. Baker, E. R. 1973. Digest ofState Pesti cide Use and Application Laws. EPA Operations Division. l a-55j 2. Federal Environmental Pesticide Con trol Act of 1972. Public Law 92-516. Amendment to Federal Insecticide, Fungicide, and'Rodenticide Act of 1947 3. Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, 21 U.S.c. 301 et/seq. 1938. Miller Amendment, 68 Stat. 511; 21 U.S.c. 346a. 1954. As amended 1958. Delaney Clause, 21 U.S.C. 348(c)(3)(A) 4. Federal Insecticide Act, 36 Stat. 335; 7 U.S.C. 121. 1910 5. Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 135-135K. 1947 6. House of Representatives Conference Report No. 92-1540. October 5, 1972. Federal Environmental Pesticide Con trol Act 7. Jensen, J. H. 1969. Report of Committee on Persistent Pesticides of the National Research Council's Division 0/ Biology
and Agriculture, 1-34 8. Model Pesticide Use and Application Act. 1971. Council of State Govern ment's Suggested State Legislation. 1971. 30:185-200 9. Mrak, E. M. 1969. Report of the Secre
tary's Commission on Pesticides and Their Relationship to Environmental Health U.S. Dep. Health, Education
and Welfare 10. Senate Report No. 92-838. June 7, 1972. Report to Accompany H.R. 10729. 16 . II. Suggested State Pesticide Control Act. 1973. The 1973-74 Official Publication of the Association of American Pesti cide Control Officials, 20-39 12. Suggested State Pesticide Use and Ap plication Act. 1973. Council of State Government's Suggested State Legisla tion. 1974. 33:80-100 13. Uniform State Insecticide, Fungicide, and Rodenticide Act. 1946. Council of State Government's Suggested State Legislation, Program for 1947. 1946. A89-109
