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24 ELR 10449 | Environmental Law Reporter | copyright © 1994 | All rights reserved A Practitioner's Guide to the Federal Insecticide, Fungicide, and Rodenticide Act: Part ILinda J. Fisher, Peter L. Winik, Carolyne R. Hathaway, Ann Claassen, and Jeffrey Holmstead Editors' Summary: Since 1910, the federal government has played a role in regulating pesticides. At first the motive was to fight fraud, but as pesticides became more sophisticated and as environmental concerns grew, the government's regulatory efforts became more comprehensive. Now, near the dawn of bioengineered pesticides, with society confronting and reevaluating environmental risks, and with agencies facing fiscal challenges, pesticide regulation continues to evolve. It is a field of concern to the pesticide industry, of course, but in U.S. society, pesticides have a marked impact on almost everyone's food supplies, water, housing, and health. This Article is the first of a three-part series explaining pesticide regulation. This installment gives a capsule history and overview of FIFRA, followed by discussions of federal jurisdiction over pesticides, labeling and packaging requirements, and the overarching requirement of pesticide registration. Future installments will examine end-user requirements, food tolerance regulations, state authority, emerging biotechnology regulation, and other issues. Linda J. Fisher, former Assistant Administrator of EPA for Prevention, Pesticides, and Toxic Substances, is Environmental Counsel at the Washington, D.C., office of the national law firm of Latham & Watkins. Peter L. Winik is a partner and Carolyne R. Hathaway and Jeffrey Holmstead are senior associates with that firm. Ann Claassen is a senior associate with the firm of Weinberg, Bergeson & Neuman in Washington, D.C. The authors acknowledge contributions to the manuscript from Mark E. Newell, partner, and Donna J. Williams, Christopher J. Peters, Chad Johnson, and Jeffrey L. Hallos, associates, of Latham & Watkins. The authors also thank reviewers James V. Aidala Jr. and William L. Jordan for their thoughtful comments on the manuscript. I. Objectives and Overview of FIFRA The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)1 is the primary federal law for the regulation of pesticides.2 It governs the manufacture, sale, and use of a broad range of chemical and biological pest controls as well as substances such as ripening agents used to control plant [24 ELR 10451] growth.3 It also includes limited authorities over mechanical pest control devices.4 If statutes could be said to have drama, the central drama of FIFRA is a struggle between environmental and economic objectives. FIFRA attempts to prevent environmental harm while allowing farmers, home owners, and other users access to effective pest controls. That conflict grows out of the environmental paradox of pesticides. Pesticides are intended to be toxic. At the same time, they are designed to be released into the environment. An ideal pesticide would be highly selective and would be harmful only to the target pest. In the real world, many of our most useful pesticides are toxic to a broad range of species and pose general environmental threats if abused. As with many federal pollution control laws, FIFRA's most complex requirements fall on manufacturers. The manufacturing phase itself offers minor environmental threats compared with what may happen with end use of the product. The regulator must focus on manufacturers because they are a practical point of control and enforcement. The policy debates that drive regulation, though, usually begin by looking at environmental effects that follow product use. Beyond manufacturing, FIFRA also regulates pesticide sale, labeling, and use. The major regulatory components of FIFRA include: * Labeling of Pesticides. All pesticides must bear a U.S. Environmental Protection Agency (EPA)-approved label that describes the pesticide's active ingredients, the hazards it poses, and its proper use. Using a pesticide in a way not described on the label is illegal. Part III of this Article discusses labeling and packaging requirements. * Registration of Pesticides. With limited exceptions, no one may sell or distribute a pesticide product in the United States unless it has been registered with EPA. The registration process gives EPA tremendous leverage over all aspects of pesticide research, manufacture, sale, and use. Parts IV and V of this Article discuss registration of pesticides and related requirements. Part XII discusses the requirement for registrants to report new information on environmental effects. * Regulation of Use. Besides the requirement that users apply pesticides according to their labels, EPA requires people to be certified before they may use certain restricted pesticides. Retailers and commercial applicators must keep records of the sale and use of restricted pesticides. Relatively new regulations protect workers exposed to pesticides. This Article discusses all these issues in Part VI. * Enforcement and Other Authorities. FIFRA provides for civil penalties, administrative actions, and criminal penalties to enforce its provisions. It also has provisions governing rulemaking, consultation, and judicial review. These are covered in Parts VII and VIII. Part XI explores what authorities are available to states. * Regulation of Storage, Disposal and Transportation. In 1988 Congress expanded FIFRA to empower EPA to regulate storage, disposal, and transport of pesticides. Part IX discusses this authority. * Import and Export Requirements. Special requirements apply to import and export of pesticides. Part X discusses these. This Article also discusses some pesticide regulation issues that go beyond the confines of FIFRA. Part XIII discusses the regulation of pesticide residues in foods. Part XV discusses the regulation of pesticides produced through biotechnology. Finally, Part XVI discusses ongoing policy issues that will shape emerging pesticide law. B. Legislative Origins of FIFRA First enacted in 1947, FIFRA has been amended numerous times and revised dramatically over the past 45 years. The principal milestones in FIFRA's history are briefly summarized below. The federal government stepped into the field of pesticide regulation with the Insecticide Act of 1910.5 The Act was not particularly ambitious, doing little more than prohibiting the sale of fraudulently labeled pesticides. It did not establish specific standards for pesticides nor did it require their registration with the government.6 Congress enacted FIFRA in 1947, superseding the Insecticide Act of 1910.7 The statute had two main features. First, it focused on disclosure to pesticide users by establishing product labeling requirements and providing for seizure of products that did not comply with those requirements (so-called misbranded pesticides). Second, the Act mandated that pesticides sold or distributed in interstate or foreign commerce (but not those sold only in intrastate commerce) be registered with the U.S. Department of Agriculture (USDA). Although a registration requirement remains in force, the 1947 statute's provisions bore little resemblance to those in place today. The Secretary of Agriculture had no mandate to evaluate the environmental effects of the pesticides for which registrations were sought or issued and lacked authority to reject an application or to cancel an existing registration. Indeed, an applicant who was informed by the Secretary that its product did not comply with requirements of the statute could nevertheless obtain a so-called registration under protest.8 There were only two significant developments in the first 25 years after FIFRA's enactment. First, in 1964 Congress amended the Act to strengthen the Secretary of Agriculture's enforcement authority. In particular, for the first time the [24 ELR 10452] law empowered the Secretary to refuse to register a new product or to cancel an existing registration, as well as to suspend a registration where necessary to address an imminent hazard to the public.9 Second, when EPA was created in 1970, it was assigned the functions of the USDA's Pesticide Division and other responsibilities for pesticide matters.10 4. Federal Environmental Pesticide Control Act of 1972 The most sweeping amendment in FIFRA's history occurred when Congress enacted the Federal Environmental Pesticide Control Act of 1972 (FEPCA).11 The most significant change was that the Act directed EPA not to register pesticides that caused unreasonable adverse effects to the environment. To buttress this mandate, FEPCA broadened EPA's jurisdiction and powers. For example, the Act extended the registration requirement to intrastate distribution of pesticides; it required establishments that produced pesticides to be registered; it authorized EPA to regulate the use of pesticides, such as by registering certain pesticides only for restricted use as opposed to general use; it established broad new data submission and recordkeeping requirements; it directed EPA to review the registration of pesticides in use (reregistration); and it strengthened EPA's enforcement powers. FEPCA also amended FIFRA in ways intended to benefit pesticide registrants. The statute provided that EPA would pay compensation to registrants and applicators who became unable to sell or use existing stocks of pesticides that were canceled or suspended. In addition, the statute specified that an applicant could not rely on data submitted by another unless the applicant paid reasonable compensation for the data, and created a mechanism for protecting submitted data that qualified as trade secrets. In 1975, Congress again amended FIFRA in several respects.12 Responding to concern that EPA did not give agricultural need sufficient weight in its decisionmaking, Congress required EPA to give the Secretary of Agriculture advance notice of proposed regulations, registration cancellations, and other actions, and created a Scientific Advisory Panel to review such proposed actions. The 1975 amendments also provided that in deciding whether to issue a notice of intent to cancel a pesticide, EPA must take account of the impact of such a cancellation on agriculture. 6. Federal Pesticide Act of 1978 Another major modification of FIFRA occurred when Congress enacted the Federal Pesticide Act of 1978.13 These amendments effected many significant changes, including provisions that empowered EPA to issue conditional registrations where all of the necessary data to support the registration were not yet available; that revamped the Special Review process for assessing whether already registered pesticides caused unreasonable adverse effects; and that substantially overhauled the provisions concerning data rights and data compensation. The most significant aspect of the FIFRA Amendments of 198814 was their creation of a comprehensive reregistration program. In 1972, FEPCA had required EPA to reregister all then-registered pesticides within four years under the Administration's new regulations promulgated under FEPCA.15 In 1978, Congress changed that unmet requirement by instructing EPA simply to undertake reregistration in the most expeditious manner practicable. Because EPA had made little progress, the 1988 Amendments enacted a detailed reregistration program, encompassing all active ingredients first registered before November 1, 1984. The initial time frame for reviewing all active ingredients was nine years, and the program was to be funded by increased fees. The 1988 Amendments also made several other important changes to FIFRA, such as largely eliminating EPA's responsibility to reimburse holders of canceled or suspended pesticides; addressing the storage and disposal of pesticides (including canceled and suspended pesticides); establishing a fast track procedure for registering "me-too" products;16 and strengthening EPA's enforcement powers. The Food, Agriculture, Conservation, and Trade Act of 199017 and the Food, Agriculture, Conservation, and Trade Act Amendments of 199118 further revised FIFRA and created some related provisions outside the Act. The 1990 law established recordkeeping requirements outside of FIFRA for certified applicators of restricted use pesticides. Among its other provisions, it required public notice and an opportunity to comment on a registrant's application for voluntary cancellation. The 1991 law corrected technical and clerical errors in FIFRA. A few key definitions, plus some limited exclusions, set the extent of FIFRA's jurisdiction. FIFRA requires registration of all "pesticides" sold or distributed in the United States. It also grants EPA limited authority to regulate "devices" through labeling and establishment registration. A. The Definition of Pesticide FIFRA defines "pesticide" not in terms of the inherent characteristics of particular substances, but rather in terms of the intent underlying the use of a substance: "'pesticide' [24 ELR 10453] means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest; and (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant.…"19 "Pest" is defined as (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator [of EPA] declares to be a pest under section 25(c)(1).20 To elaborate on the key element of intent, EPA has adopted regulations providing that a pesticide is "any substance (or mixture of substances) intended for a pesticidal purpose,"21 and enumerating three factors to be addressed in deciding whether a substance is for a pesticidal purpose: * Whether the person who distributes or sells the substance claims that it has a pesticidal purpose or use or contains an active ingredient that can be used to manufacture a pesticide. * Whether the substance contains an active ingredient and has no commercially valuable use other than for a pesticidal purpose or use or for the manufacture of a pesticide. * Whether the person who distributes or sells the substance has knowledge that the substance will be used or is intended for use for a pesticidal purpose.22 These factors look primarily to the intent or constructive intent of the distributor rather than the user. Labels or advertising material that recommend a product for use against a pest may be clear evidence of that intent.23 At least one court has applied an objective standard to determine intent. Rather than inquire about a company's actual, subjective intent, the court asked whether the company could expect a reasonable consumer to use the product against pests.24 Some years after that ruling, EPA incorporated an objective standard into its regulations.25 In the preamble to that rulemaking, EPA stated: The Agency does not intend to impose penalties upon the producer of a non-pesticide product, if, without his knowledge, a pesticidal claim is made for the product by someone else. EPA agrees that it would be unreasonable to require registration of a product whose primary uses are non-pesticidal merely because a retailer sold the product as a pesticide. On the other hand, EPA believes that a producer who sells a product with full knowledge of its intended pesticidal use should be held responsible for its registration. This situation might apply, for example, when a producer sells what would ordinarily be considered a basic chemical to a user whose only purpose in acquiring such a chemical would be to use it as a pesticide. If the seller of the product is aware of the nature of his customer's business, EPA may consider him to be selling a product for a pesticidal purpose.26 B. Substances Not Subject to FIFRA's Registration Requirements FIFRA and its implementing regulations identify numerous categories of substances that do not need to comply with the registration requirements. These substances typically are excluded from the regulatory scheme for one of two reasons: they are not within the definition of pesticide or they are otherwise specifically exempted from the registration program. 1. Substances Not Within the Regulatory Definition of Pesticide EPA has specifically identified certain products that are not subject to FIFRA requirements because they are not pesticides [24 ELR 10454] as defined in the statute. Three such categories are summarized below. a. Substances Not Used Against a Pest EPA has stated that the following products are not intended for use against a pest and therefore are not pesticides: * products intended for use only against microorganisms, internal parasites, or nematodes in or on living humans or animals, and labeled accordingly; * products, such as fertilizer, intended only to aid the growth of desirable plants; and * products intended to force bees from hives for collection of honey.27 b. Substances Without a Pesticidal Effect Similarly, EPA has identified certain products that are not pesticides because their intended use does not have a pesticidal effect.28 Several types of product or articles fall into this category, including deodorizers, bleaches, and cleaning agents; nontoxic products intended only to attract pests for survey or detection, and labeled accordingly; and nontoxic products that are intended only to provide a physical barrier against pest access, such as tree pruning paints.29 c. Research and Development Substances Yet another class of substances arguably not pesticides subject to FIFRA are those in the initial stages of research and development. EPA experimental use regulations state: A substance or mixture of substances being put through laboratory or greenhouse tests, or limited replicated field trials to confirm such tests, or other tests, in which the purpose is only to determine its value for pesticide purposes or to determine its toxicity or other properties, and from which the producer, applicator or any otherperson conducting the test does not expect to receive any benefit in pest control from its use, is not considered a pesticide within the meaning of the Act.… 30 EPA presumes such a purpose for tests conducted on a cumulative total of not more than 10 acres of land or not more than one surface acre of water, or for tests conducted only on experimental animals.31 More extensive testing may be permissible as long it is for research and development (R&D) only.32 Despite the language just quoted, EPA takes the position that some portions of FIFRA apply to R&D pesticides. EPA regulations require R&D pesticides to bear a FIFRA label if transferred or sold.33 Other EPA regulations apply to the export of R&D pesticides.34 In the preamble to its new export policy, the Agency stated: "EPA disagrees with those commentors who stated that R&D pesticides are not pesticides regulated under FIFRA. The Agency does regulate R&D pesticides under FIFRA, even though the Agency may have determined that certain R&D pesticides would not be subject to all the requirements of FIFRA.…"35 In conformance with this position, EPA has proposed to amend the language of its experimental use regulations "to clarify that the determination of whether an EUP [an experimental use permit] is required is based on risk considerations, rather than on a definitional presumption about whether the substance is a pesticide."36 The amended language would read: An experimental use permit is generally required for testing of any unregistered pesticide for a use not previously approved by EPA in the pesticide's registration. However, as described below …, certain of such test[s] using a pesticidal substance or mixture of substances are presumed not to involve unreasonable risks and, therefore, do not require an experimental use permit.37 Under the proposed amendment, the circumstances under which R&D pesticides need not be registered nor subject to an EUP are essentially the same as those of the current rule. However, a new subsection would be added that would require notification prior to testing a genetically engineered microbial pesticide, even if the test involves less than one acre of surface water or less than 10 acres of land.38 2. Specific Products Exempted From Some or All FIFRA Requirements FIFRA also contains several specific exemptions from requirements for substances that fall within the regulatory definition of pesticide. Some of these exemptions are unconditional and complete; others contain conditions or apply to only certain FIFRA requirements, such as registration. Section 25(b) authorizes EPA to exempt any pesticide from all requirements of the Act if EPA determines that the pesticide is adequately regulated by another federal agency, or if EPA determines it is not of a character requiring regulation under FIFRA.39 EPA has exempted two classes of substances on the basis that they are adequately regulated by another federal agency:40 biological control agents, except [24 ELR 10455] microorganisms;41 and products offered solely for human use that are regulated under the new drug provisions of the Federal Food, Drug, and Cosmetic Act. EPA has found the following classes of substances not to require regulation under FIFRA, when used as specified in the regulations:42 * A substance or article containing a pesticide, e.g., paint containing a biocide, if the pesticide itself is registered for such use and the purpose of the pesticide is to protect the substance itself. (Thus, if the purpose of the biocide is to preserve the paint itself, the paint need not be registered under FIFRA. If the purpose of the biocide is to control microorganisms on objects to which the paint is applied, this exemption does not apply.); * Pheromones labeled for use only in pheromone traps for insects and other arthropods, and the traps themselves; * Preservatives for biological specimens, such as embalming fluids, educational specimen preservatives, and preservatives for body fluids for laboratory analysis; * Low-toxicity vitamin hormone products for non-food plants; and * Foods used to attract pests. EPA has determined that certain custom blends, usually of a pesticide and a fertilizer, do not need to be registered, provided the following conditions are met:43 * the blend is prepared to the order of the user and is not held in inventory by the blender; * the labels of the pesticides used in the blend do not prohibit use of the product in such a blend; * the blend is prepared in a registered establishment; and * the blend is delivered to the user together with a copy of the end use labeling for the pesticides used in the blend and a statement specifying the composition of the mixture. c. Section 18 Emergency Exemptions If EPA determines that emergency conditions exist, it may exempt any federal or state agency from portions of FIFRA.44 The agency may then notify licensed pesticide applicators in the area covered by the exemption of the availability of the exempted pesticide.45 EPA has established procedures for authorizing such exemptions.46 EPA may authorize four types of emergency exemptions: * a specific exemption, to avert a significant economic loss or a significant risk to endangered or threatened species, beneficial organisms, or the environment; * a quarantine exemption, to control the introduction or spread of a pest new to or not widely prevalent in the United States; * a public health exemption, to control a pest that poses a significant risk to human health; and * a crisis exemption, for use when there is insufficient time to obtain authorization for one of the above exemptions.47 For a specific, quarantine, or public health exemption, the state or federal agency must submit an application to EPA that describes the pest and the threat posed by the pest, the pesticide to be used, the location and method of use, potential risks associated with the use, and an explanation of why alternative pesticides registered for the use or alternative practices are not adequate to deal with the emergency.48 EPA is to review the petition expeditiously and approve the use if it determines that an emergency condition exists, that use of the pesticide under the exemption will not cause unreasonable adverse effects on the environment, and that the pesticide use is not one for which registration has been suspended or canceled under FIFRA § 6.49 For certain applications, EPA first issues notice of receipt in the Federal Register and provides a 15-day public comment period. Such notice and comment is required if the application proposes use of a new chemical, the first food use of an active ingredient, or use of a pesticide that is subject to a suspension notice or a special review.50 As required by the Act, EPA will consult with the governor of any state concerned and the Secretary of Agriculture if they so request.51 If there is insufficient time for the normal exemption application process, the head of a state or federal agency, or the governor of a state, or their official designee may issue a crisis exemption for a period not to exceed 15 days.52 If feasible, EPA is to be notified at least 36 hours before issuance of the crisis exemption.53 The crisis provision may not be used if EPA has informed the agency head or governor or designee notto issue such an exemption, if the pesticide use has been suspended or canceled under FIFRA § 6, if the pesticide contains a new chemical, or if the use would be the first food use of the pesticide.54 d. Transfers of Unregistered Pesticides For limited purposes, EPA allows pesticides to be sold or [24 ELR 10456] otherwise transferred without a registration.55 Manufacturers may transfer pesticides between registered establishments that are operated by the same producer.56 Manufacturers may transfer pesticides between registered establishments that are not operated by the same producer for purposes of further packaging or formulation, provided certain conditions are met.57 Persons may transfer pesticides in accordance with an experimental use permit58 or may transfer the pesticides solely for export, provided the export is in compliance with the requirements of EPA's export policy.59 Also, persons may transfer unregistered pesticides solely for purposes of disposal in accordance with an EPA order or FIFRA § 19.60 Congress authorized EPA to designate devices that shall be subject to the provisions of FIFRA §§ 2(q)(1) (labeling requirements) and 7 (establishment registration).61 Devices are also subject to §§ 8 (books and records), 9 (inspection of establishments), 12 (violations), 13 (enforcement), 14 (penalties), 17 (imports and exports), and 25(c)(3) (child-resistant packaging).62 FIFRA § 2(h) defines a "device" as: any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides when sold separately therefrom.63 EPA regulations essentially define "device" the same way, adding an example of equipment used for pesticide application: Tamper-resistant bait boxes for rodenticides.64 In general, an article is a device if it uses physical or mechanical means (as opposed to a chemical or biological agent) to control the pest. In a 1975 preamble to regulatory amendments, EPA exercised its statutory authority to specify classes of devices subject to FIFRA §§ 2(q)(1) and 7.65 The Agency reiterated these designations in a Consolidation and Clarification of Requirements for pesticidal devices published in 1976.66 EPA stated that devices subject to §§ 2(q)(1) and 7 included, but were not limited to: (A) certain ultraviolet light systems, ozone generators, water filters and air filters (except those containing substances or mixtures of substances which are pesticides), and ultrasonic devices, for which claims are made to kill, inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites; (B) certain high frequency sound generators, carbide cannons, foils, and rotating devices, for which claims are made to repel birds; (C) black light traps, fly traps, electronic and heat screens, fly ribbons, and fly paper, for which claims are made to entrap or kill insects; (D) mole thumpers, sound repellents, foils and rotating devices, for which claims are made to repel certain mammals.67 EPA does not consider this list to be all-inclusive. For example, the Agency has determined that electromagnetic devices are also subject to FIFRA §§ 2(q)(1) and 7.68 EPA has specifically found that two types of devices are not subject to FIFRA.69 One is "[t]hose which depend for their effectiveness more upon the performance of the person using the device than on the performance of the device itself." EPA gives fly swatters and tillage equipment for weed control as examples. The other is "[t]hose which operate to entrap vertebrate animals." EPA gives mouse traps and fish traps as examples III. Labeling and Packaging Requirements Pesticide labeling, both historically and currently, is the fulcrum on which FIFRA turns.70 Labeling encompasses labels71 and all other written, printed, or graphic matter accompanying the pesticide or any such matter to which the label or literature accompanying the pesticide refers.72 EPA uses labeling requirements to enforce safety and efficacy standards and to communicate with users about risks and proper use. Labeling enables manufacturers to show they are in compliance with FIFRA. Indeed, as mentioned above in Part II, statements made on labeling often suggest [24 ELR 10457] whether a product is intended to be used as a pesticide and thus is subject to FIFRA. As every holder of a pesticide registration knows, registered pesticides must have EPA-approved labels; in fact, a draft of the label must accompany the registration application.73 Part III herein of this Article discusses in detail the label requirements for registered pesticides. EPA regulations apply the same requirements to several other classes of pesticides: Pesticides subject to an experimental use permit (EUP), unregistered pesticides being tested but expressly exempt from the need for an EUP, pesticides distributed or sold under emergency exemptions, and unregistered pesticides being transferred for disposal.74 It is a direct violation of the statute to distribute any pesticide, registered or not, without an ingredients statement, directions for safe use, information about the manufacturer, and other basic information on the label.75 Several different sources provide guidance on how to develop a pesticide label. First, FIFRA indicates that a pesticide is "misbranded" if there are certain deficiencies in its label.76 Second, the Code of Federal Regulations sets forth specific labeling requirements, governing, for example, the content and placement of a label.77 Additionally, the EPA's Office of Prevention, Pesticide, and Toxic Substances occasionally issues Pesticide Regulation Notices, also known as PR Notices. The PR Notices address various topics, including substantive labeling requirements.78 Finally, the EPA publishes a guide entitled General Information on Applying for Registration of Pesticides in the United States, also known as the Bluebook, which covers the basics on how to register a pesticide and how to apply for use permits.79 A pesticide label must include the name of the product, the name of the producer, the net contents, the registration numbers for the product and for the producing establishment, an ingredient statement, warning or precautionary statements, directions for use, and the use classification, i.e., general or restricted, of the product.80 The ingredient statement must include the name and percentage by weight of each active ingredient and the total percentage by weight of all inert ingredients.81 For each ingredient the statement must use the accepted common name82 followed by the chemical name. The statement may use the common name alone only if it is well-known. If EPA has not established a common name, the statement may use the chemical name alone.83 The statement must give the percentages of ingredients in terms of weight-to-weight.84 Statements for pesticides that change in chemical composition must include the statement, "Not for sale or use after [date]," and the product must meet all label claims up to the expiration date.85 b. Warnings and Precautionary Statements Required warnings and precautionary statements fall into two groups: Those that must appear on the front panel of the labeling and those that may appear elsewhere. The front panel must ordinarily include a basic signal word indicating toxicity, a statement of practical treatment for exposure if the pesticide is highly toxic, and a child hazard warning.86 The regulations set out requirements for placement and prominence of these items.87 In addition, the regulations require specific warnings for environmental hazards, hazards to humans and domestic animals, and physical or chemical hazards such as flammability.88 For example, the regulations require that each label bear the statement "keep out of reach of children" unless the registrant can demonstrate that the likelihood of contact with children during distribution, marketing, storage, and use is "extremely remote."89 When a hazard exists to non-target organisms, the regulations require an appropriate warning, such as "This Pesticide is Toxic to Wildlife."90 Additionally, for all outdoor uses other than aquatic applications, [24 ELR 10458] the label must bear the warning "keep out of lakes, ponds, or streams. Do not contaminate water by cleaning of equipment or disposal of wastes."91 Any specific warnings required by the regulations do not need to appear on the front label. The requirements for warning statements are detailed, but their specificity actually might benefit manufacturers by serving as a defense against allegations that a warning was inadequate. This Article discusses the complex issue of FIFRA's preemption of state tort claims later in Part XI.D.2. Labels must include use directions that the average person likely to use or to supervise the use of the pesticide can easily understand.92 The directions may appear on any portion of the labeling, provided that they are conspicuous enough for the user to read easily.93 When followed, directions must protect the public from fraud and personal injury and must prevent unreasonable adverse effects on the environment.94 EPA regulations list specific items that the directions for use must include.95 The directions must explain permissible sites of use, target pests, dosage rates, methods and frequency of application, worker protection precautions, limits on reentry to treated areas, storage and disposal directions, and any other restrictions that safety or environmental protection demand. The list seems designed both to promote safe use of the pesticide and allow EPA to enforce safe use. The directions must remind the consumer that "[i]t is a violation of Federal law to use this product in a manner inconsistent with its labeling."96 As these requirements together suggest, EPA regulates pesticide use through the use directions. With some exceptions, uses inconsistent with the labeling terms and conditions are violations of FIFRA,97 as are the advertisement or recommendation of such uses.98 This Article discusses restrictions on pesticide use later in Part VI.A. EPA has authority to classify a pesticide product for restricted or general use or to leave the product unclassified.99 EPA uses the "restricted" classification to place extra safeguards on highly toxic pesticides. These safeguards generally include the requirement that the pesticide only be sold to and applied by certified applicators.100 As to labeling, restricted use pesticides must bear statements of restricted use classification on the front panel, which include the statement "Restricted Use Pesticide" and, directly below that, a summary statement of the terms of restrictions imposed. Additionally, sometimes EPA requires the label to state the specific reason for the restricted use pesticide classification, such as aquatic toxicity or danger of groundwater contamination. If use is restricted to certified applicators, the following statement is required: "For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification."101 Any advertising of restricted use pesticides must include prominent mention of the classification or specific restrictions.102 EPA normally does not classifyproducts for general use, believing the term to be "potentially misleading if a user infers from the statement that the product may be used for 'general' purposes not listed on the label."103 Instead, products not classified as restricted usually remain unclassified.104 Those pesticide products that do bear directions for uses classified as general must have the words "General Classification" on their labels immediately below the heading "Directions for Use."105 2. Prominence, Legibility, and Language Label contents must be legible and conspicuous. The required text must be in six-point or larger type, appear on a clear contrasting background and not be obscured or crowded. Such text must appear in English and, where necessary to protect the public, another language or languages.106 Not only is EPA specific in detailing the information required on a label, its regulations also are specific in directing where that information must appear. The label must appear on or be securely attached to the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label also must be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold.107 4. "Misbranded" Pesticide Products or Devices Manufacturers can put claims, including advertising, on the [24 ELR 10459] labeling, so long as the claim does not differ or detract from the approved label or obliterate or obscure the required label language.108 A pesticide product or device is misbranded, however, if "its labeling bears any statement, design, or graphic design relative thereto or to its ingredients which is false or misleading in any particular," including either pesticidal and nonpesticidal claims.109 No one may sell, distribute, or offer for sale a misbranded product or device.110 Determining whether a pesticide is misbranded goes beyond determining whether the statements in the labeling are true. EPA considers claims misleading and therefore unlawful when the manufacturer cannot support the claims with test data.111 Omitting information required under the labeling regulations also is misbranding,112 as is marketing a product in a size too small to satisfy its advertising or labeling claims.113 To avoid misleading users, EPA historically has forbidden direct or comparative safety claims such as "safe," "nonpoisonous," "noninjurious," "harmless," or "nontoxic to humans and pets," and nonnumerical or comparative statements on the safety of the pesticide, such as "contains all natural ingredients," "[a]mong the least toxic chemicals known," and "[p]ollution approved."114 As a result, pesticide labels generally provide no clear basis for comparing risks among alternative pesticides, making it hard for users to choose the pesticide practices most likely to prevent needless pollution or risk to public health and the environment.115 EPA would like to encourage development, registration, and use of pesticides or pest control practices that present lower risks to public health and the environment. To do this, EPA is considering relaxing the prohibition on direct and comparative safety and efficacy claims. For example, the Agency is considering allowing claims that a product is "lower risk" or "safer" than alternatives, or that a product is compatible with the environment, e.g., that the pesticide is "Environmentally Friendly."116 As a corollary, EPA also is considering requiring especially hazardous pesticides to be labeled to highlight that fact to potential users.117 However, EPA remains concerned about undermining labeling's precautionary emphasis, inviting abuse of unsubstantiated safety claims, or causing confusion and dissemination of misinformation among consumers.118 FIFRA does not grant EPA plenary authority to regulate advertising as such. Pesticide advertising119 does become subject to FIFRA when it accompanies the product as it is sold or distributed (and so becomes part of the product's labeling),120 or when it makes claims that differ substantially from claims approved during registration.121 b. Unregistered Pesticides and Uses In 1983, a task force122 recommended that EPA strengthen its position on advertising based on numerous instances of potentially false or misleading advertising of § 5 experimental use permits, § 18 emergency exemptions, § 24(c) special local need registrations, and pending new registrations. EPA concluded that advertising pesticides for uses that are not yet registered, particularly if the pesticide is available for other uses, likely would encourage misuse. A person who sees an advertisement for an unregistered use of a registered pesticide may be tempted to try the pesticide for that illegal use.123 EPA also agreed with the task force that by preventing or limiting advertising of uses of pesticides that are subject of experimental use permits, emergency exemptions, or special local need registrations, the Agency could lessen the likelihood that those pesticides would be misused.124 As a result, EPA now prohibits the advertising of (1) any pesticide for a use authorized under a FIFRA § 5 experimental use permit; (2) any pesticide for a use authorized under an emergency exemption, except for advertisements targeted to the geographic areas covered by the exemption that identify retail dealers who stock the product and state the limitations on the use authorized under the exemption; (3) any pesticide for a use authorized by a FIFRA § 24(c) special local need registration, unless the advertisement includes a notice of the limitations on use; (4) any unregistered pesticide; or (5) any registered pesticide for any use not permitted by its registration.125 News items and announcements are not covered if the information they give on the pesticide does not extend beyond that contained in EPA's approval, and if the limitations on use are clearly specified.126 Likewise, articles in scientific journals reporting on scientific studies are not considered advertising.127 With some exceptions,128 once EPA has registered a pesticide and approved its label, the manufacturer may not change the label without EPA's prior approval.129 An applicant may submit a proposed labeling modification with an application for amended registration, and EPA must approve the application before anyone may legally distribute or sell the product with the new labeling. EPA established a Label Improvement Program in 1980 to allow or require registrants to update and improve their labeling without awaiting reregistration.130 EPA's Registration Division issues label improvement directives in the form of Pesticide Registration Notices sent by certified mail to affected registrants. A notice identifies specific labeling changes to be made and establishes a schedule for compliance, taking into account the need to dispose of existing stocks. If an individual registrant fails to comply, EPA may issue a cancellation notice pursuant to FIFRA § 6(b). Within 30 days after EPA issues a cancellation notice, a registrant may file an objection and request a hearing to challenge the need for the required label changes. "[T]o protect children and adults from serious injury or illness resulting from accidental ingestion or contact"131 EPA requires child-resistant packaging (CRP) for pesticides or devices that are toxic or otherwise dangerous and that are likely to come into the hands of unwary people. EPA requires CRP for pesticide products intended for residential use that meet toxicity criteria and that are not classified for restricted use, packaged in large sizes or otherwise exempted.132 The toxicity criteria correspond generally to FIFRA toxicity categories I and II (products bearing signal words "Danger" and "Warning").133 EPA may also require CRP for pesticides that fall below the toxicity criteria or for devices (for which the toxicity criteria do not apply) if they pose a serious hazard of accidental injury that CRP could help prevent.134 Residential use includes use on people or pets, and use in or around household structures and outbuildings, pleasure boats, recreational vehicles, preschools, or day care facilities.135 In deciding whether a product is intended for residential use, EPA looks first to the labeling.136 For example, the product meets the criterion if the labeling explicitly [24 ELR 10461] recommends residential use, if the labeling mentions use at residential sites, e.g., kitchens, baths, gardens, ornamental plants and flowers, pools, or if the use directions are appropriate for residential sites, e.g., dosages are given in tablespoons or for garden rows.137 Generally, EPA will not require CRP for a product clearly labeled only for agricultural or institutional use with no conflicting directions that could be interpreted as homeowner-oriented. Similarly, EPA will generally not require CRP for a product whose label clearly prohibits sales to or use by homeowner or residential users and whose labeling does not detract from this statement.138 EPA cannot look to labeling alone, however, because there is no way to ensure the product is marketed only as stated on the label. For example, if a manufacturer labels a product for agricultural use only but markets it through retail outlets that primarily serve homeowners, EPA will consider it intended for residential use. EPA generally considers products marketed in small sizes to be directed at residential users. At the same time, producers of specialty products who market only through distinct channels of trade to nonresidential users may reasonably consider their products to be nonresidential and thus not subject to CRP.139 EPA grants exemptions from CRP requirements to products and devices classified for restricted use and products packaged in large sizes, since these categories of pesticides are not generally intended for residential use and thus are not expected to reach inquisitive children.140 EPA also may grant an exemption (1) if it is satisfied that the hazards indicated by the toxicity criteria are not indicative of the hazards to man or (2) based on specified technical considerations, including the product's toxicity, the feasibility, practicality, or appropriateness of the CRP, the composition or use of the product, and the like.141 If granted, the exemption also will apply to other products of substantially similar composition.142 Even if the product fits into an exemption, however, EPA can nevertheless require CRP if it determines that the pesticide product or device poses a risk of serious accidental injury or illness that CRP could reduce.143 Once granted, an exemption may be withdrawn if the lack of CRP actually results in serious illnesses or injuries to children.144 A pesticide that falls under CRP regulations but "is contained in a package or other container or wrapping which does not conform to the standards established by the Administrator" is misbranded and therefore unlawful.145 CRP must meet the following standards: [] Effectiveness. CRP must meet the effectiveness standards prescribed by the Consumer Product Safety Commission (CPSC).146 [] Compatibility. The chemical and physical characteristics of the pesticide product or device must not compromise or interfere with the proper functioning of CRP and the packaging must not be detrimental to the integrity of the product during storage and use.147 [] Durability. Appropriate technical evaluation based on physical wear and stress factors of packaging, the force required for activation, and other relevant factors must show that the package's effectiveness and compatibility continue to meet the requisite standards for the reasonably expected lifetime of the packaging.148 The registrant of a pesticide product or device required to be in CRP must certify to EPA that the packaging meets the standards described above. The certification must contain (1) the product or device's name and EPA registration number, the registrant's name and address, the date, and the name, title, and signature of the company official making the certification; and (2) a statement that the packaging meets the requisite standards.149 For as long as the registration of a pesticide product or device required to be in CRP is in effect, the registrant must maintain the following records: A description of the container and the closure or child-resistant mechanism; a copy of the certification statement; verification that each package [24 ELR 10462] for the product is child-resistant; and verification that the package meets the compatibility and durability standards. A central feature of FIFRA is its requirement that pesticides be registered with EPA.150 EPA grants registrations only after careful review of data regarding the pesticide. EPA protects public health and the environment by refusing or conditioning registration in appropriate cases. FIFRA prohibits almost any sale or distribution of an unregistered pesticide in the United States, and EPA can condition continued validity of a registration on submission of data by the registrant, use of specified labeling, and so forth.151 Therefore, registration provides EPA with a powerful tool for requiring ongoing research on the effects of pesticides, as well as a tool for enforcing the provisions of FIFRA. A. Registration Standards and Scope 1. The Standard for Approving a Registration FIFRA provides that EPA shall register a pesticide if it determines that, in conjunction with any restrictions that may be placed on use of the pesticide, it works as claimed; the materials submitted with the registration application, including the labeling, comply with FIFRA requirements; and expected use of the product will not cause unreasonable environmental harm.152 The first factor addresses the concern of economic fraud. Although this concern historically was a major reason for the Act, it more recently has been overshadowed by health and environmental concerns. FIFRA provides that EPA may waive data requirements pertaining to efficacy.153 EPA routinely requires submission of efficacy data for antimicrobial products and vertebrate pesticide products, but not for most insecticide, fungicide, or herbicide products.154 However, registrants must test their products to ensure that they are effective, and EPA may require submission of such data on a case-by-case basis.155 The registration approval process focuses on the potential health and environmental effects of the pesticide. The standard, "unreasonable adverse effects,"156 incorporates a cost-benefit analysis. FIFRA defines unreasonable adverse effects on the environment to mean "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide."157 That a pesticide will cause some degree of adverse effects is almost to be expected, since a pesticide generally is capable of killing or inhibiting life. On the other hand, the species that pesticides target are pests, and their loss or destruction is beneficial. EPA's task, then, is to determine whether the benefits of the pesticide's use outweigh its potential adverse effects. Specifically excluded from the cost-benefit equation is the question of whether the pesticide is essential. EPA also is not to register one pesticide in preference to another, provided both pesticides meet the requirements of the Act.158 However, EPA is developing policies to encourage the development, registration, and use of pesticides or pest control practices that present lower risks than existing high-risk pesticides. EPA provided notice of its Reduced-Risk Pesticide Policy Initiative in the Federal Register in July 1992, with a request for comments.159 EPA has held workshops on its Reduced-Risk Initiative in October 1992 and June 1994.160 The Montana federal district court succinctly summarized FIFRA's registration standard this way: Under FIFRA, the EPA is required to register a pesticide if it determines (1) the pesticide's labeling and other materials comply with FIFRA's requirements; and (2) the pesticide, when used properly, will perform its intended purpose without unreasonable adverse effects on the environment.161 The Ninth Circuit has held that EPA does not need to prepare an environmental impact statement under the National Environmental Policy Act162 before it can register a pesticide.163 When EPA does not have enough data to make an unconditional registration decision under FIFRA § 3(c)(5), EPA may conditionally register a pesticide under FIFRA § 3(c)(7).164 Currently, most new pesticide registrations are conditional.165 If the new pesticide is substantially similar to a pesticide that is already registered, EPA may conditionally register the new pesticide if such approval would not significantly [MISSING PAGE] One could add that, in yet other circumstances, "pesticide" refers to a substance that is used to control pests yet is not subject to FIFRA.181 One must rely on context to determine how "pesticide" is being used in a particular instance. In any event, a pesticide registration applies to a single pesticide product with a defined composition, physical state, and end use. Under a single registration, EPA may approve several alternate formulations, consisting of a given active ingredient and varying inert ingredients.182 Otherwise, however, any variation in the ingredients -- their number or relative percentages -- results in a separate product, which must be separately registered. A change in the intended use of the product, e.g., additional types of crops, requires a separate or amended registration. (This is not obvious from a review of the Registration Procedures subpart of the regulations, but is implicit in the requirements that the label include directions for the use of the product and that the proposed label be submitted with the registration application.)183 The technical grade of the active ingredient may itself be a registered product. Without a FIFRA registration, no one may distribute or sell a technical grade chemical as a pesticide product or for formulation into pesticide products,184 unless one of the exceptions to FIFRA jurisdiction discussed above applies.185 However, EPA encourages registrants to register the technical grade even if they are not legally required to do so. "[A]dministrative complications and data requirements are reduced if your source of the active ingredient(s) is registered."186 B. Specific Forms of Registrations A new chemical registration involves registration of a pesticide containing an active ingredient that has not been previously registered or used in a registered formulation. Because EPA has neither an existing database nor prior experience with respect to the chemical, these registrations are the most difficult to obtain. The process of generating and evaluating data can take years. If the pesticide product to be registered contains an active ingredient that is already registered, but has not previously been used in the manner proposed for the new product, it is a new use registration. For example, if an active ingredient previously had been registered only for use to control indoor insects, use of that active ingredient on food crops would be a new use. In such a case, EPA can use existing data and experience to help evaluate the product, but EPA may need new data to evaluate the potential effects of the pesticide in the new application. New uses include any use affecting foods that would require establishment or increase of a residue tolerance; any new aquatic, terrestrial, outdoor, or forestry use pattern; or any other new use pattern that would increase potential exposure to the pesticide.187 If the product for which the new use is proposed is a product that is already registered, the new use can be registered through the registration amendment process.188 Registering a pesticide product that is identical to or substantially similar to a pesticide that is already registered is known as a "me-too" registration. To qualify as substantially similar, the new product must contain the same active and similar inert ingredients, in approximately the same percentages, and must have the same or similar uses. Factors such as an increase in dosage rate, change of inert ingredients, or use of an unregistered source for the active ingredient may disqualify a product from being considered a me-too product.189 Me-too applications for end use products are subject to an expedited review process.190 4. Supplemental Registrations and Transfers A registrant may permit another person to distribute or sell a registered product under the other person's name by obtaining a supplemental registration.191 To apply for a supplemental registration, the registrant submits EPA Form 8570-5, Notice of Supplemental Registration of Distributor. The so-called distributor product must be essentially a duplicate of the producer's product, except for the name and other minor changes in labeling. Also, with EPA approval, a registrant may transfer a registration to another person.192 To take a common example, a corporation undergoing a merger, divestiture, or bankruptcy reorganization will want to transfer its registrations to the new corporate entity. The old and new registrant must jointly submit the transfer application. The transfer may not have any incidental legal strings attached; EPA will not allow conditional transfers or transfers ascollateral or security for some other obligation. The new registrant will take on any obligations to the Agency under FIFRA that the old registrant had. The old registrant will keep any rights to compensation for use of registration data,193 unless the registrant separately transfers those rights. States may authorize additional uses for federally registered [24 ELR 10465] pesticides to meet local needs.194 This Article discusses this authority later in Part XI.E. If the registrant wishes to make any significant change in the pesticide product, it must submit an application for an amended registration, unless EPA waives such requirement.195 Significant changes include a change in the concentration of the active ingredient, a substitution of an inert ingredient, or an additional use for the pesticide product. The application for amended registration includes the same elements as an application for registration of a new pesticide product. Registrants may make minor modifications, such as a change in the source for an inert ingredient, simply by notifying EPA.196 Registrants may make some minor changes in labeling and packaging, e.g., correcting typographical errors, with no notification.197 If the proposed amendment is for a use, dosage rate, application method, or other element that already appears on another substantially similar or identical product, it is a me-too amendment. Like me-too registrations, a me-too amendment is subject to an expedited review process. If data supporting an application for an amendment to permit new uses are insufficient to support an unconditional amendment, EPA may conditionally amend the registration.198 EPA must determine that the applicant has submitted sufficient data on the proposed use and that the conditional amendment will not significantly increase the risk of adverse effects on the environment.199 EPA may not permit the additional use if it involves a food crop and EPA has issued a notice stating that any ingredient of the pesticide exceeds dietary risk criteria.200 D. The Registration Application 1. Administrative Process and Timing EPA's Office of Pesticide Programs Registration Division administers the registration process. A person wishing to register a pesticide product must submit an application to the Registration Division.201 EPA has developed several forms to be used; applicants can obtain the forms from: Registration Division (H5704C) U.S. Environmental Protection Agency 401 M St. SW, Washington, DC 20460 Part IV.D.2 of this Article, below, discusses information to be included in the application. If the application is for registration of a pesticide containing a new active ingredient or is for a new use pattern, EPA publishes a notice in the Federal Register. Interested parties have 30 days to comment on the application.202 FIFRA directs EPA to make a determination to register a pesticide or deny approval of registration "as expeditiously as possible."203 In reality, the process can be very lengthy, taking years before EPA deems the application complete and reviews all the data. To avoid delay in the review process, the applicant should strive to ensure that the application is complete and accurate in every detail. EPA will not begin review of an application until it is complete.204 Also, if at any time during the application review EPA determines it is deficient in any manner, EPA will halt the review process. EPA will notify the applicant of the deficiency, and the applicant then has 75 days to respond. EPA treats failure to respond as a voluntary withdrawal of the application, so that the applicant must reapply to pursue registration.205 To ensure that the application is complete, the applicant should consult with EPA before submitting the application. The Agency will provide potential applicants with an application package that includes a manual, General Information on Applying for Registration of Pesticides in the United States,206 and the proper application forms. Included in the manual is a list of product managers -- persons in charge of various types of pesticide registrations, e.g., chlorinated organic insecticides, fungicides, antifouling paints. The product manager can resolve questions about data requirements.207 The registrant should keep in touch with the product manager during the registration process to identify potential problems and resolve them promptly.208 Me-too Applications. The 1988 amendments to FIFRA created an expedited review process for me-too applications.209 Within 45 days of receipt of a me-too application, [24 ELR 10466] EPA is to determinewhether it is complete. If it is not complete, EPA will deny the application. If it is complete, EPA has another 45 days (90 days from receipt of the application) to approve or deny the application.210 If, after full review of the application and associated data, EPA approves the registration, it so notifies the applicant. For approvals involving new chemicals or new uses, EPA also publishes a notice in the Federal Register.211 Within 30 days of registration, EPA will make the application information and data on which EPA made its decision available to the public.212 If EPA determines that the pesticide product will not meet either the unconditional or conditional standards for registration,213 it notifies the applicant with a statement of reasons and conditions that the applicant must correct prior to registration.214 The applicant then has 30 days to comply or to withdraw the application. If the applicant does neither, EPA may publish a notice of denial in the Federal Register, specifying the reasons for the denial.215 In practice, EPA rarely has occasion to formally deny an application for registration. Normally, a company would not seek registration of a new active ingredient or product unless it was confident the new product would meet EPA's criteria for registration. When EPA has concerns about the potential risk of the product, the Agency and the applicant work together to identify additional data needs or label restrictions to address those concerns. If EPA and the applicant cannot resolve the issues, the applicant usually will choose to withdraw the application. This is because new pesticides often are developed for worldwide markets, and a formal EPA denial of registration may adversely affect the marketability of the product in other countries. Within 30 days of the publication of a notice of denial, the applicant, or another person acting with written approval of the applicant, may petition EPA for a hearing.216 An administrative law judge (ALJ) hears the appeal.217 Either party may appeal the decision of the ALJ to the EPA Environmental Appeals Board.218 Within 60 days after EPA issues its final order, the applicant or person who has been party to the proceedings may file a petition for judicial review in a U.S. court of appeals.219 Venue is in the appellate circuit wherein the petitioner lives or has a place of business.220 Applications to register a pesticide or amend a registration must include the following elements. Applicants must submit a complete application form, EPA Form 8570-1. The Registration Support Branch of the Office of Pesticide Programs can supply copies of the form.221 The applicant must supply its name and address of record.222 If EPA has assigned a company number to the applicant, the applicant must supply that also. An applicant who does not reside in the United States must designate an agent in the United States to whom EPA will send correspondence. Applicants need to keep EPA informed of their current address. EPA sends notices of requirements for additional data or other conditions of registration, which usually have time limits for response, to the address of record. c. Product Identity and Formula The application must specify the name of the product being registered, its trade names, and its EPA registration number if it is already registered.223 In addition, the applicant must submit a Confidential Statement of Formula (EPA Form 8570-4), which lists each ingredient in the product, the ingredient's concentration in the product, its purpose, and any associated impurities.224 The applicant must submit five copies of the proposed labeling with the application.225 This Article discusses the requirements for labeling above in Part III.A. The applicant must submit enough data to enable EPA to determine whether the pesticide meets the environmental and sometimes also the efficacy standards for registration.226 Part IV.E of this Article, below, describes these data requirements. The application must include a summary of all data being submitted with the application.227 If relying on [24 ELR 10467] data previously submitted in support of another registration, the applicant must submit certification that any applicable permission or compensation requirements have been complied with, using EPA Form 8570-29.228 If the product requires child-resistant packaging,229 the application must include a certification that the product will be distributed or sold only in such packaging.230 The Act states that applicants shall request that the pesticide be classified for general use, for restricted use, or for both.231 Normally, pesticides that are not restricted are simply unclassified (rather than classified for general use).232 If the applicant wishes a classification other than that determined by EPA, the application should include a request and information supporting the request.233 h. Statement Concerning Tolerances If the intended use of the pesticide may result in residues being present in food, the applicant must state whether the Federal Food, Drug, and Cosmetic Act authorizes such residues. If not, the applicant must petition for the establishment of a tolerance or for exemption from the requirement.234 The heart of the pesticide registration application consists of the data that the applicant must submit regarding the pesticide. The data requirements are most burdensome for a pesticide containing a new active ingredient, for then the applicant must generate all required data elements. If the pesticide uses an active ingredient that is already registered, the applicant may be able to rely, in part or wholly, on data generated by previous applicants, subject to data compensation requirements. EPA's regulations detail the data requirements.235 The regulations include tables indicating what types of studies the applicant must arrange, depending on the intended use of the pesticide. EPA requires some data on the active ingredient and some on the complete pesticide formulation.236 EPA may require data beyond that listed in the tables if it determines such data are necessary to evaluate the potential effects of the pesticide.237 At a minimum, all applications must provide information on the product chemistry.238 This includes the Confidential Statement of Formula,239 plus physical and chemical characteristics such as melting point and density. The applicant must certify that each ingredient listed in the Statement of Formula will be present at the stated concentration, within specified limits (known as certified limits).240 In most cases, the applicant must also provide acute toxicity data on the pesticide formulation.241 Additional types of data that may be required include the following:242 * Residue Chemistry -- the amount of the pesticide that will remain on food or feed crops; * Environmental Fate -- information on degradation (hydrolysis and photolysis), metabolism, mobility (leaching, volatilization), dissipation, and bioaccumulation; * Animal toxicity studies -- in addition to acute toxicity, EPA may require subchronic or chronic studies, teratogenicity and reproduction studies, mutagenicity studies, and metabolism studies; * Reentry protection -- data needed to assess potential exposure of workers entering fields that have been treated with the pesticide; * Spray drift evaluations -- data that indicate the potential for the pesticide to reach nontarget organisms; * Nontarget organism data -- toxicity data on birds, fish, and other organisms that may be adversely affected by the pesticide use; and * Product performance data -- data to prove the pesticide is efficacious for its stated purpose. Such data is usually required to be submitted only for antimicrobial or vertebrate pesticide products. EPA, the pesticide industry, and academia have formed task groups to create databases for exposure and spray drift data. A pesticide handler's exposure database (PHED) is now available, containing actual field measurement variables that can be used to evaluate exposure from mixing, loading, and application of pesticides. An applicant may be able to use data from the database in lieu of an actual study. The PHED database may be purchased through EPA's contractor, Versar.243 A similar database is being created for spray drift information. Biochemical, Microbial, and Genetically Engineered Plant Pesticides. The data requirements for biochemical, microbial, and genetically engineered plant pesticides are somewhat different from those typically required for other types of pesticides. EPA is in the process of creating [24 ELR 10468] a new policy regarding data requirements for these types of pesticides. EPA does not expect to publish a final policy in the near future, but persons wishing to register biochemical, microbial or genetically engineered plant pesticides should confer with EPA to determine what data EPA will require. Inert Ingredients. In 1987, EPA instituted a policy to review the safety of inert ingredients and to encourage the use of the least toxic ingredients available.244 The Agency reviewed approximately 1,200 substances that had been used in registered pesticide products and grouped them into the four lists, as follows: * List 1 -- inerts of toxicological concern; * List 2 -- potentially toxic inerts, with high priority for testing; * List 3 -- inerts of unknown toxicity; and * List 4 -- inerts of minimal concern. EPA published List 1 and List 2 in the Federal Register in 1987 and published updated lists in 1989.245 In March 1989, EPA issued data call-ins246 on all List 1 inerts, except di(2-ethylhexyl)phthalate and di(2-ethyl-hexyl)adipate. All registrants chose to voluntarily cancel their registrations or committed to reformulate their products to eliminate use of these inerts rather than generate the data required under the data call-ins. EPA issued data call-ins for di(2-ethylhexyl)phthalate and di(2-ethylhexyl)adipate in March 1994. Any applicant who wishes to use a List 1 inert ingredient in a pesticide product will need to generate the data specified in the data call-in for that inert as part of the application process. EPA is monitoring List 2 inerts to determine whether it should require further testing. The Agency will register products containing List 2 inerts if the product is closely similar to existing products. If a new use is proposed for the product, EPA will determine on a case-by-case basis whether it requires additional data on the inert and whether it should register the product. If an inert ingredient proposed for use in a pesticide product has never been used in a registered pesticide, EPA will require data sufficient to evaluate the risks associated with use of the inert ingredient. The minimal data set generally will consist of basic product chemistry, residue chemistry, toxicology, ecotoxicology, and environmental fate data.247 To ensure that data are meaningful, EPA has established standards for good laboratory practice (GLP).248 These standards apply to studies supplying data supporting registration-related applications and to any other request to allow pesticide marketing or research, such as applications for experimental use permits (EUPs), food tolerances, or exemptions.249 The standards apply to studies conducted since October 16, 1989.250 GLP regulations govern laboratory management, facility quality, and study conduct.251 Testing facilities must allow EPA to inspect them to verify compliance with GLP standards.252 If any data in an application come from a study to which GLP standards apply, the application must include a statement declaring whether the study complied with the standards. The applicant, the financial sponsor of the study, and the person actually responsible for the overall conduct of the study all must sign the statement.253 Applicants must submit all required data in the form of individual studies, in triplicate. EPA has set a general format for the studies254 and more detailed requirements for studies performed under GLP standards.255 A statement accompanying each study must declare whether the applicant claims that any data in the study are confidential.256 This Article discusses protection of trade secrets and other confidential information in Part IV below.257 EPA requires applicants to flag several kinds of studies that might show whether the pesticide causes cancer, birth defects, or neurotoxicity. EPA has listed six generic classes of studies of this type, and for each class EPA has written criteria that would indicate that the results of the study show potential adverse effect of special concern. With every study that falls within these six classes the applicant must include a signed statement declaring whether the study meets or exceeds any of the criteria for special concern.258 3. Use of Previously Generated Data Most applications for new pesticide products do not rely on new active ingredients but instead use active ingredients that EPA has previously registered. EPA therefore already has received most or all of the data it would require for the new product. Applicants can rely on data previously submitted, but may be required to obtain permission from and offer compensation to the originator of the data.259 EPA maintains a database of all data submitted in support of applications, along with the identity of the original data submitter. EPA also generates data evaluation reports (DERs), which summarize each study submitted and its adequacy for meeting the applicable data requirement. These DERs can be obtained through Freedom of Information Act (FOIA) requests. a. Original Data Submitter Rights FIFRA gives applicants who submit original data some proprietary rights to those data. A new applicant that wants to rely on data submitted to support an earlier registration of an active ingredient first registered after 1978, must have written permission from the original data submitter. This prohibition lasts for 10 years following the original registration.260 For 15 years following the submission of any data to support or maintain a registration, EPA may consider the data to support a new application only if the new applicant has made an offer to compensate the original data submitter for the use of the data.261 These so-called data compensation provisions are the product of a fairly tumultuous lobbying battle between two concerns. On the one hand, first applicants, having borne substantial testing expenses, do not wish subsequent applicants to have a free ride for their own registrations. On the other hand, a requirement that subsequent applicants duplicate all testing requirements would be wasteful and could deter healthy competition. Congress enacted the current version of § 3(c)(1)(F) after previous versions had proven unworkable.262 This version has withstood constitutional challenges based on Article III and the Takings Clause of the Fifth Amendment.263 Arbitration. FIFRA provides no guidance on how to determine what is adequate compensation.264 It does direct, however, that if the original data submitter and applicant cannot agree on the compensation within 90 days, the matter may go to binding arbitration. The Federal Mediation and Conciliation Service (FMCS) has developed regulations for arbitration of pesticide data disputes.265 Arbitrators have supported use of the following factors in determining compensation: cost of the original study, including supervision costs and other overhead; replacement cost of the study; the risk the original data submitter took in potentially developing adverse data; the competitive advantage to a new applicant of using the data; and whether the data are used only in the United States or in other countries. Arbitrators have not supported compensation schemes that would provide windfall profits to the original data submitter.266 If an applicant formulates an end use pesticide product using a registered pesticide purchased from another person, then FIFRA exempts the applicant from the requirement to submit or cite any data pertaining to the purchased product and from the data compensation requirements.267 This exemption applies only to safety data, e.g., toxicity studies, and not to efficacy data.268 EPA considers efficacy data to be product-specific and therefore one formulation may not rely on efficacy data supporting another. The exemption generally applies only to data on the safety of the active ingredients and not of the end use product itself, unless the new product is simply a repackaging of the purchased product. Persons relying on the formulator's exemption must submit a Formulator's Exemption Statement (EPA Form 8570-27) with the application. 4. Protection of Trade Secrets FIFRA § 10 provides for the protection of trade secrets and commercial and financial information in required data submissions.269 Such information is called confidential business information (CBI). The applicant must clearly indicate the information for which a confidentiality claim is made, otherwise it is not CBI. EPA regulations include specific procedures for marking and submitting such information.270 EPA then makes its own determination whether the information is a trade secret or is privileged or confidential commercial or financial information.271 If so, EPA may not make the information public; a federal employee or contractor who willfully and improperly discloses confidential information is subject to a $ 10,000 fine, one-year imprisonment, or both.272 In addition, it is a violation of FIFRA for any other person who acquires confidential information under the Act to disclose that information or to use it for his or her personal advantage.273 EPA may determine that information which an applicant has labeled as CBI, is not entitled to such treatment. If the Agency proposes to publicly release the information, EPA must notify the registrant or applicant by certified mail. The registrant or applicant then has 30 days in which to initiate an action in a district court for declaratory judgment as to whether the information is entitled to confidential treatment.274 Under several circumstances, EPA may disclose information that otherwise would be protected under the confidentiality provisions. EPA may give other federal agencies information relating to the formula of products and may disclose such information at public hearings and in findings of fact.275 EPA may disclose information to government contractors, if EPA determines the contractor must have the [24 ELR 10470] information to perform satisfactorily. The contractor must maintain the confidentiality of the information.276 EPA may disclose CBI concerning production, distribution, sale, or inventories of a pesticide in connection with a public proceeding to determine whether the pesticide causes unreasonable adverse effects on health or the environment, if EPA finds such disclosure is necessary in the public interest.277 All information concerning the environmental or health effects of a registered or previously registered pesticide or its ingredients is available for public disclosure.278 Under this last exception, EPA may not disclose CBI regarding manufacturing or quality control processes, details of methods for analyzing intentionally added inert ingredients, or the identity or percentage of any intentionally added inert ingredient, unless the Agency finds such disclosure is necessary to protect against an unreasonable risk to health or the environment.279 If EPA makes either of the two findings described in the previous paragraph and proposes to disclose otherwise protected information, it must notify the submitter by certified mail. The submitter then has 30 days (if EPA determines the risk is imminent, it can shorten this period to no less than 10 days) to commence an action in a federal district court to enjoin release of the information.280 Under FIFRA § 10(g), EPA may not release any information submitted by an applicant or registrant to a foreign business or a multinational corporation without first obtaining the submitter's consent.281 This provision applies even if the applicant or registrant has not specifically designated the information as CBI. However, under the export regulations, EPA will provide a copy of the purchaser acknowledgement (which contains information on the product identity and shipment destination) to foreign governments, even if a confidentiality claim is made.282 In addition to the provisions of the Act, EPA has promulgated regulations for the handling of confidential information claims within the Agency.283 However, the general policy of EPA is "make the fullest possible disclosure of records to the public," consistent with CBI rights.284 If a FOIA request is made to the Office of Pesticide Programs for documents containing CBI information (for example, a request for data evaluation reports), the Agency will redact the confidential information and then provide the document to the requester. 5. Continuing Data Requirements: Data Call-Ins; Section 6(a)(2) At any time, EPA may determine that additional data are needed to support continued registration of a pesticide (usually a particular active ingredient).285 In such case, EPA notifies all affected registrants of the additional data requirement. This is known as a data call-in. The registrants must show within 90 days of receipt of the data call-in notice that they are taking appropriate steps to comply with the additional requirements. Failure of any person to comply with the data call-in may result in suspension of that person's pesticide product registration.286 If the additional data requirement affects an on-going application, EPA must provide the applicant with time to develop the data.287 EPA can conditionally register a pesticide for a period sufficient to allow the generation and submission of additional data.288 Besides data call-ins, a registrant has a continuing obligation to submit any new information on unreasonable adverse environmental effects that may come to the registrant's attention.289 This Article explores this obligation in detail later in Part XII. FIFRA prohibits distribution or sale of an unregistered pesticide. However, to generate the data required for a registration application, the applicant may need to test an unregistered substance, which in turn may require distribution. If the applicant keeps the testing within narrow limits, EPA does not consider the substance to be a pesticide, and therefore the applicant may distribute the substance without a registration.290 For more extensive testing, FIFRA provides for the issuance of an EUP to enable the applicant to generate the data required for a registration.291 A person applying for an EUP must use EPA Form 8570-17, "Application for Experimental Use Permit." The applicant must explain the purposes for any testing to be conducted under the EUP and must detail the proposed testing program. Also, the applicant must provide the names and addresses of all persons participating in the testing program (including persons giving permission to apply the pesticide to their land).292 If the applicant is seeking the EUP for an unregistered product, the applicant must provide a Confidential Statement of Formula and other product chemistry. In addition, the applicant must submit results of acute toxicity studies and certain other data.293 Tables in FIFRA regulations list the kinds of data that the applicant must provide.294 3. Tolerances If the experimental pesticide is for use on a food crop and EPA has set no residue tolerance for the pesticide, the applicant must request the establishment of a tolerance or a temporary tolerance. Alternatively, the applicant must certify that the food resulting from the EUP program will be destroyed or will only be fed to experimental animals.295 The EUP holder must label the experimental pesticide with a prominent statement that it is "For Experimental Use Only," and that it is "Not for sale to any person other than a participant or cooperator of the EPA-approved experimental use program."296 The label also must bear certain other information such as an ingredient statement and cautionary statements.297 EPA usually issues EUPs for a period of one or two years.298 EPA may condition the permit in any manner it determines necessary to protect public health and the environment.299 If EPA has not previously registered the experimental pesticide, EPA also may require the permit holder to conduct studies to determine whether the pesticide causes adverse effects.300 EPA may revoke the EUP at any time if it determines that the permittee is not in compliance with the conditions of the permit or that the EUP program use is causing unreasonable adverse effects.301 EPA may authorize a state to issue EUPs.302 EPA has promulgated regulations governing state issuance of EUPs.303 Upon approval of a state plan for the issuance of Experimental Use Permits, EPA will place a notice in the Federal Register. To date, Florida, Idaho, and Vermont have obtained approval to issue EUPs.304 In 1988, Congress added a new § 4 to FIFRA to accelerate the reregistration of pesticides.305 Section 4 of FIFRA requires EPA to reregister all pesticides containing an active ingredient that was a component of any pesticide initially registered before November 1, 1984.306 The purpose of reregistration is to review the approval of pesticides in light of current data and safety standards. The only pesticides exempted from reregistration are those for which EPA determined between November 1, 1984 and December 24, 1988 that there are no outstanding data requirements and the requirements for registration in FIFRA § 3(c)(5) have been satisfied.307 FIFRA § 4 outlines a five-phase process for reregistering covered pesticides and establishes a schedule for completing this process. In accordance with the schedule, EPA commenced the first phase of the reregistration process in March 1989.308 As discussed below, the first four phases have been completed, and EPA currently is evaluating the health and environmental effects data submitted by registrants for particular active ingredients and pesticides. During Phase I, FIFRA required EPA to publish four lists of pesticide active ingredients: Active ingredients for which registration standards had been issued prior to December 24, 1988 (List A); the 150 active ingredients not on List A for which reregistration was the highest priority (List B); of the remaining unlisted active ingredients, the 150 active ingredients for which reregistration was the highest priority (List C); and all other registered active ingredients (List D).309 EPA published Lists A, B, C, and D on February 22, May 25, July 24, and October 24, 1989, respectively.310 Pursuant to § 4, after publishing each list, the Agency sent registrants of pesticides containing the listed active ingredients a notice indicating the date by which they were required to notify EPA during Phase II as to whether they intended to seek reregistration of their pesticides.311 In response to EPA's reregistration notice, registrants of pesticides containing List B, C, or D active ingredients had to notify the Agency of their intent to seek reregistration of their pesticides.312 Registrants intending to reregister their pesticides also had to send to EPA a list of missing and inadequate data for each registered pesticide and a commitment to submit replacement studies for the missing or inadequate data.313 Registrants had to submit the replacement data to EPA within a period of time determined by EPA, which could not exceed two years unless "extraordinary [24 ELR 10472] circumstances beyond the control of the registrant prevent[ed] the registrant from submitting data within such prescribed period."314 FIFRA allowed EPA to cancel pesticide registrations for which the registrant did not submit a notice of intent to reregister.315 During Phase III, each registrant of a pesticide containing a List B, C, or D active ingredient who submitted a notice of intent to reregister had to submit the following documents to EPA: *Summaries of studies previously submitted to EPA to support the registration of the pesticide; *A reformatted outline of the data for each summarized study addressing chronic dosing, oncogenicity, reproductive toxicity, mutagenicity, neurotoxicity, teratogenicity or residue chemistry, or if such data were not required for the active ingredient under FIFRA § 3 or its implementing regulations, a reformatted outline of acute and subchronic data; * Data indicating an adverse effect caused by the pesticide; * Other information that the registrant believed would support the registration; * A certification that the registrant or EPA has access to the summarized data; * A commitment to submit outstanding data identified by the registrant or an offer to share in the cost of developing these data; and * Evidence of compliance with FIFRA § 3(c)(1)(F) for all previously submitted data.316 In accordance with FIFRA § 4(e)(4), EPA issued guidelines for reformatting the required data.317 If a registrant's data submission did not conform to EPA's guidelines, FIFRA directed EPA to determine whether the registrant made a good-faith effort to conform to the guidelines.318 If the registrant made a good-faith attempt to comply with the guidelines, the Agency provided the registrant a reasonable period of time to correct its submission.319 However, if EPA determined that the registrant did not make a good-faith effort to comply, FIFRA § 4 authorized the Agency to issue a notice of intent to cancel the registration.320 Registrants were entitled to request a hearing but the only issue that the hearing could address was whether the registrant made a good-faith attempt to conform its submission to EPA guidelines.321 FIFRA § 4(e)(3) authorized EPA to cancel all pesticide registrations for which registrants failed to submit the information required during Phase III. During Phase IV, FIFRA required EPA to review the registrants' submissions to determine whether the submissions identify all missing or inadequate data for each active ingredient.322 The Agency was required to publish a notice in the Federal Register that identifies the outstanding data requirements for each active ingredient on Lists B, C,and D in accordance with the following schedule: * 18 months after the listing date for List B substances; * 24 months after the listing date for List C substances; and * 36 months after the listing date for List D substances.323 If the Agency issued a notice to a registrant indicating the need for additional data for an active ingredient, the registrant was required to submit such data within the time identified by EPA (which cannot exceed 48 months). If extraordinary circumstances beyond the registrant's control prevented timely compliance, the registrant could petition EPA for more time.324 EPA was required to issue a notice of intent to suspend a pesticide's registration if the Agency determined that (1) The registrant had not initiated the tests necessary to fill all outstanding data requirements within one year after the Agency published the Federal Register notice that identified the data requirements; (2) a registrant's progress was insufficient to ensure a timely submission of the data; or (3) the registrant had not submitted the data to the Agency in accordance with FIFRA § 4's schedule.325 During the final phase of the reregistration process, EPA must review all the data that registrants submit concerning each active ingredient and any other relevant data that the Agency locates to determine whether pesticides containing the active ingredient are eligible for reregistration.326 EPA must make this determination within one year after receiving all data concerning the active ingredient.327 EPA may [24 ELR 10473] extend this time for up to one year "for extraordinary circumstances."328 Before reregistering a pesticide, EPA may require product-specific data in addition to the data concerning the active ingredient.329 The registrant must submit such data within eight months after the Agency determines that the active ingredient is eligible for reregistration, unless the Agency determines that a longer period is required to generate the data. EPA must review such data within 90 days after their submission.330 After reviewing all data for each active ingredient and the product-specific data, EPA must determine whether to reregister a pesticide. The standard for this determination is whether, "when used in accordance with widespread and commonly recognized practice it will not generally cause any unreasonable health effects on the environment."331 If the pesticide does not satisfy this standard, EPA must take appropriate regulatory action, which could include cancellation of the pesticide. If a new application relies on data submitted during reregistration, whoever originally submitted the data is entitled to compensation, the same as with reliance on data used to support an initial registration.332 In setting fair compensation, FIFRA directs the arbitrator to consider the reregistration fees, which this Article discusses next.333 FIFRA required most registrants of pesticides containing an active ingredient included on List A, B, C, or D to pay an initial fee upon submitting a notice of their intent to reregister a pesticide.334 FIFRA exempted some minor use, low value, and low volume pesticides.335 EPA apportioned reregistration fees for pesticide-active ingredients among registrants based on their market share of U.S. sales of the active ingredient for the three calendar years preceding the date such fees were paid.336 EPA apportioned the reregistration fees based upon reports submitted by the registrants.337 EPA canceled registrations held by registrants who did not submit such information after receiving notice of the reporting requirement or who did not pay their share of the fee.338 The Agency then reapportioned the fees among the remaining registrants and notified such registrants that the fees were required to be paid within 30 days after receiving the notice.339 FIFRA § 4 requires each registrant to pay an annual fee.340 EPA has currently set the fee at $ 650 for the registrant's first pesticide and $ 1,300 for each additional registration up to 200 registered pesticides. EPA must adjust the maintenance fees to a level that yields an aggregate amount of $ 14 million each fiscal year.341 Notwithstanding the identified maintenance fees for each registration, FIFRA § 4 limits the aggregate maintenance fees that registrants must pay. The maximum annual maintenance fee for registrants holding 50 or fewer pesticide registrations is $ 55,000, and the annual maintenance fee paid by registrants holding more than 50 registrations cannot exceed $ 95,000.342 The maximum annual maintenance fees for small business registrants are slightly less: $ 38,500 for registrants holding 50 or fewer pesticide registrations; and $ 66,500 for registrants holding 50 or more pesticide registrations.343 Moreover, EPA may reduce or waive maintenance fees for pesticides registered for a minor agricultural use if the Agency determines that the fee would reduce significantly the availability of the pesticide for such use.344 If a registrant fails to make a timely payment of maintenance fees, EPA may, by order and without a hearing, summarily cancel the registration.345 Beginning in October 1997, EPA will require fees to accompany any application for new registrations, EUPs, metoos, and amendments. The tentative fee schedule appears in FIFRA regulations.346 H. Suspension and Cancellation of Pesticide Registrations FIFRA authorizes the Agency to suspend and cancel pesticide registrations. A suspension is a temporary measure that allows the Agency to prohibit distribution or use of a pesticide pending taking action to cancel the pesticide. Suspensions are only allowed if necessary to prevent an imminent hazard, i.e., one that might occur before EPA could cancel the registration. The cancellation of a pesticide is permanent, and EPA may seek it on a number of grounds. 1. Suspension of a Pesticide Registration EPA may suspend a pesticide registration immediately if the Agency determines that the suspension is necessary "to [24 ELR 10474] prevent an imminent hazard during the time required for cancellation or change in classification proceedings."347 However, EPA may not issue a suspension order until it has issued a notice of intent to cancel the registration or to change the classification of the pesticide.348 Before issuing a suspension order, the Agency must notify the registrant.349 This notice must include the findings upon which EPA has relied to make its imminent hazard finding.350 A registrant may request an expedited hearing before EPA on the issue of whether the pesticide presents an imminent hazard.351 If the registrant does not request a hearing within five days after receiving the suspension notification, the Agency's suspension order takes effect and no court may review it.352 If the registrant requests a hearing, the hearing must commence within five days after the Agency receives the request unless the registrant and the Agency agree to a later date.353 The presiding officer at the hearing (generally an ALJ) must submit recommended findings and conclusions within 10 days after all evidence has been presented.354 EPA then has seven days to render a final order on the suspension issue.355 If EPA determines that an immediate suspension is required to prevent an emergency with respect to the registered pesticide, EPA may issue a suspension order before notifying the registrant and prior to holding a hearing.356 The registrant may challenge the suspension order under the same procedure as discussed above.357 However, the suspension is effective pending the issuance of a final order.358 FIFRA § 6 authorizes certain parties to seek judicial review of suspension orders. A federal court of appeals may review EPA's final order of suspension following an administrative hearing even though related cancellation proceedings have not been completed.359 In contrast, suspension orders entered before a hearing are subject to immediate review in an appropriate federal district court with such review limited solely to determining whether thesuspension order was arbitrary, capricious, an abuse of discretion or not issued in accordance with procedures established by law.360 Only affected registrants or other individuals with the consent of the registrant may seek judicial review. The only relief a district court may order is a stay of the suspension order pending EPA's final decision with respect to cancellation or changing classification.361 Judicial review may go forward simultaneously with administrative review proceedings under this section.362 a. Cancellation After Five Years FIFRA § 6(a) requires EPA to cancel a pesticide's registration five years after its effective date if the registrant or an interested person who has obtained the registrant's approval does not request that the registration be continued.363 If no one requests continuation within 30 days prior to the expiration of the five-year period, EPA must publish a notice in the Federal Register indicating that the registration will be canceled unless the registrant or an interested person (who has the approval of the registrant) requests that the registration be continued.364 If the registration is canceled, EPA may allow existing stocks to be sold and used if such sale or use "will not have unreasonable adverse effects on the environment."365 EPA has seldom invoked this provision. b. Cancellation Initiated by EPA Standards. EPA may cancel a registration if the pesticide, its labeling, or other material required to be submitted are not in compliance with the provisions of FIFRA or if the pesticide, "when used in accordance with widespread and commonly recognized practice, generally causes unreasonable [24 ELR 10475] adverse effects on the environment."366 To make an unreasonable adverse effect determination, EPA must weigh the pesticide's potential risks against its benefits.367 FIFRA § 6 explicitly requires EPA to "take into account the impact of [the cancellation] … on production and prices of agricultural commodities, retail food prices and otherwise on the agricultural economy."368 Process. EPA initiates the cancellation process by issuing a notice of its intent to cancel the registration or by conducting a hearing to determine whether the registration should be canceled.369 Notices of intent to cancel must include an explanation of the factual basis for the Agency's decision. EPA must seek input from the USDA before issuing either notice. FIFRA § 6(b) requires EPA to provide a copy of the intended notice and an analysis of its impact on the agricultural economy to the USDA at least 60 days before sending the notice to the registrant or the public.370 EPA must publish any comments received from the USDA and its response to these comments in the Federal Register.371 If the USDA does not provide written comments to EPA within 30 days after receiving the Agency's notice and analysis, EPA may send the notice to the registrant and the public.372 At least 60 days prior to sending the intended notice to the registrant, EPA also must provide the Scientific Advisory Panel (SAP) with a copy of the notice of its intent to cancel a pesticide registration and an analysis of the proposed cancellation's impact on health and the environment.373 The SAP is a multidisciplinary group of seven scientists appointed by the EPA Administrator.374 EPA must publish any comments, evaluations, and recommendations from the SAP, with EPA's response, in the Federal Register.375 When EPA proposes to cancel a registration, the action becomes final and effective 30 days after the registrant receives notice or the notice appears in the Federal Register (whichever occurs later)376 unless the registrant remedies the problems with the registration or unless EPA holds a hearing on the proposal. EPA will hold a hearing at the request of any adversely affected person, or it may do so on its own initiative.377 If EPA holds a hearing, the proposed action becomes final at the completion of the hearing. Cancellation Hearings. EPA has promulgated extensive rules governing cancellation and similar hearings.378 Under these rules, a person requesting a hearing must file a statement articulating objections to cancellation.379 If EPA initiates the hearing, it must issue anotice of an intent to hold a hearing and, at the same time, a statement of issues.380 EPA will send these papers to the registrant and publish them in the Federal Register.381 A person who wants to participate in the hearing must file a written response to the statement of issues.382 The statement of issues will include a deadline for filing responses (which must be at least 30 days from the date of the notice).383 Before the hearing commences, all parties must make available to the other parties the names of all witnesses (including expert witnesses) expected to testify, a narrative summary of the expected testimony, and a list of documents and exhibits to be introduced into evidence.384 FIFRA § 6 authorizes the presiding ALJ to compel witnesses or the production of evidence through a subpoena.385 At the hearing, EPA must first present its affirmative case for canceling the registration.386 However, the party challenging the cancellation of the registration has the burden of persuasion.387 Within 90 days after completing the hearing, the ALJ must issue an order that cancels the registration or revokes the notice of intention to cancel.388 FIFRA § 6(d) requires the order to set forth detailed findings of fact upon which the ALJ's decision is based.389 After the ALJ issues the initial decision, any party may appeal the decision to EPA's Environmental Appeals Board.390 Once the Environmental Appeals Board issues a final decision, it may be judicially challenged within 60 days.391 The party challenging the final decision must file a petition for review with a U.S. court of appeals.392 The court may reverse EPA's decision only if it is not supported by substantial evidence based on the entire record.393 FIFRA § 6(f) authorizes registrants to seek voluntarily to cancel a pesticide registration, or to amend a registration to delete one or more uses, at any time.394 Prior to taking [24 ELR 10476] action at a registrant's request, EPA must publish a notice in the Federal Register indicating that it has received a request to cancel or amend the registration and provide a 30-day public comment period.395 If EPA determines that the cancellation of a pesticide registered for a minor agricultural use "would adversely affect the availability of the pesticide," the Agency must make reasonable efforts to inform persons who use the pesticide of the request to cancel.396 Moreover, the Agency may not act on the request until 90 days after the notice is published in the Federal Register, unless EPA determines that the use of the pesticide during that period "would pose an unreasonable adverse effect on the environment."397 During the 90-day waiting period, the registrant may notify EPA that it has agreed to transfer the pesticide registration to another person.398 The registrant must file an application for transferring a registration within 30 days after notifying EPA of the intent to transfer.399 After EPA receives the application, EPA must approve the transfer unless it determines that continued use of the pesticide would cause an unreasonable adverse affect on the environment.400 The new registrant must comply with all outstanding data and other requirements for the pesticide.401 3. Disposition of Stocks of Suspended or Canceled Pesticides FIFRA § 6(g) requires any person who distributes or sells any pesticide that has been canceled or suspended, including producers, exporters, registrants, applicants for registration and commercial applicators, to notify EPA and appropriate state and local officials if they possess such a pesticide.402 The notice must identify the quantity the person possesses and the location of the pesticide.403 EPA may restrict the use of suspended or canceled pesticides through several means. First, EPA may do this by the terms of cancellation or suspension orders.404 Second, EPA may issue a "stop sale, use, or removal" order to persons who own, control, or have custody of such pesticides.405 Any person receiving such an order is prohibited from selling, using, or removing the pesticide except in accordance with provisions included in the order.406 Third, the Agency may issue requirements and procedures to be followed by any person who stores or transports a suspended or canceled pesticide.407 Finally, EPA may order a recall of a suspended or canceled pesticide if the Agency determines that a recall is necessary to protect health or the environment.408 a. Persons Entitled to Indemnification Under certain circumstances, FIFRA § 15 requires EPA to indemnify manufacturers, end users, dealers, and distributors of pesticides that have been suspended or canceled.409 The following discussion summarizes the federal government's indemnity obligation to each of these groups. Manufacturers. Before indemnifying a manufacturer, EPA must report to the Committee on Agriculture in the House of Representatives, the Committee on Agriculture, Nutrition, and Forestry in the Senate, and the committees on Appropriations in both houses. EPA's report must describe the action to be taken that will require indemnification, the reasons for taking the action, the estimated cost of payment, and a request for the appropriation of funds for payment.410 EPA cannot make an indemnification payment to a manufacturer unless Congress makes a specific line item appropriation of funds in advance.411 Moreover, the indemnity obligation does not extend to manufacturers who had information that indicated that the pesticide did not meet the requirements for registration and who continued to produce the pesticide without giving timely notice of such information to EPA.412 End Users. End users are entitled to indemnification from the U.S. Treasury's judgment fund, without restriction.413 End users include all persons who immediately before the suspension or cancellation owned any quantity of the pesticide for the purpose of applying or using it rather than distributing or selling the pesticide or further processing it for distribution or sale.414 Dealers and Distributors. Dealers and distributors holding stocks of suspended or canceled pesticides must seek reimbursement from the seller for the cost of the pesticide unless the seller, at the time of the sale of the pesticide, provided written notice that no reimbursement would be made under such circumstances.415 If the seller provided such notice or is unable to reimburse dealers and distributors because of insolvency or bankruptcy, the government must indemnify such persons.416 b. Amount of the Indemnification A person may claim an indemnity payment equal to the cost of the pesticide owned by the person immediately before EPA issued a notice to the registrant of its intent to [24 ELR 10477] cancel or suspend the pesticide.417 However, the indemnity payment cannot exceed the fair market value of the pesticide owned by the person immediately before the issuance of such notice.418 In addition, EPA may provide a reasonable time for using or disposing of the pesticide.419 EPA owes no indemnity for any pesticide used or disposed of during that time.420 The Special Review process provides EPA with a means to evaluate concerns about pesticide safety.421 As part of the FEPCA amendments, in 1972, Congress required EPA to review the thousands of pesticides registered prior to 1972, and reregister only those that generally did not cause unreasonable adverse effects.422 In July 1975, EPA devised the Rebuttal Presumption Against Registration (RPAR) process to identify such pesticides.423 Later, in response, the 1978 Grassley-Allen Amendment created FIFRA § 3(c)(8). It prohibited the Administrator from initiating a "public interim administrative review process," unless based on a "validated test or other significant evidence raising prudent concerns of unreasonable adverse risk to man or to the environment."424 In 1985, the RPAR process was renamed "Special Review."425 The Special Review and Reregistration Division administers Special Reviews. The Special Review regulations prescribe the applicable procedures.426 EPA may conduct a Special Review only if the Administrator first determines that a pesticide's uses, taking into account the pesticide's ingredients, impurities, metabolites and degradation products, may pose an environmental risk. This initial determination focuses only on risk, not on potential benefits.427 The regulations detail some specific kinds of risks that may trigger Special Review, such as acute injury to humans or harm to endangered species.428 They also include a catch-all category of "risk to humans or to the environment which is of significant magnitude to merit a determination whether the use of the pesticide product offers offsetting social, economic and environmental benefits that justify initial or continued registration."429 "The Administrator may evaluate [whether a pesticide raises these risks] either on his or her own initiative, or at the suggestion of any interested person."430 EPA must give affected registrants written notification before commencing the Special Review process.431 This allows registrants an opportunity to refute the Agency's findings and thereby "furnish[es] a greater degree of protection for the property rights of pesticide registrants and ameliorate[s] the indictment-like characteristics of the interim public review process."432 The notification generally includes EPA's basis for commencing a Special Review. Registrants have 30 days from receipt of the notification to respond in writing to dispute the validity of the Agency's conclusion.433 One option available to registrants is to propose, in response, risk reduction measures in order to avoid initiation of a Special Review.434 Following this comment period, the Agency must decide whether to initiate a Special Review. If EPA decides to proceed, it must publish a Notice of Special Review including a supporting statement of reasons in the Federal Register.435 If EPA proposes not to proceed, it must publish that proposed decision and give interested persons opportunity to comment.436 EPA must then publish a final decision and a statement of reasons.437 If EPA reverses itself and decides to proceed, it must publish a Notice of Special Review as mentioned above.438 The Notice of Special Review identifies each use under review and the risk criteria that each use has triggered.439 The Notice also invites registrants, users, or other interested persons to file written comments before a set date.440 During the comment period Agency staff are free to meet with interested persons about the proceeding, and EPA may hold informal public hearings.441 After the comment period closes, EPA publishes a Notice of Preliminary Determination. This notice states EPA's conclusions about the risks from the pesticide and what action EPA plans to pursue.442 The Agency solicits public comments on the preliminary determination. It also refers the [24 ELR 10478] determination to the Secretary of Agriculture and the SAP for comment.443 The last step in the Special Review Process is the Agency's announcement of its final determination.444 The Agency may announce that it is taking no action; requiring additional label warnings, use precautions, and protective clothing requirements; or taking stronger steps including seeking permanent cancellation of the registration. If the decision involves a change in registration that stops short of cancellation of all use, the Agency will announce its intent to cancel the existing registration unless the registrant applies to amend its registration consistent with the Agency's final determination. If EPA issues a notice of intent to cancel, the cancellation of a registration pursuant to the Special Review process will take effect within 30 days unless the registrant files a timely request for a hearing pursuant to FIFRA Section 6(b). EPA has been moving away from the use of the Special Review procedures because they are time-consuming and costly.445 EPA has not initiated such a procedure since 1988.446 1. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA §§ 2-31. 2. FIFRA is not the only federal statute that affects pesticides. The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.A. §§ 301-395 (West 1972 & Supp. 1994), regulates pesticides in a number of ways. In particular, the FFDCA requires EPA to establish a "tolerance" for each ingredient of a pesticide used in connection with food or animal feed. These provisions are discussed in detail in Part XIII, to follow. In addition, pesticides may fall within requirements of various other laws regulating chemical substances, such as the Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2601-2671, ELR STAT. TSCA §§ 2-311; the Hazardous Materials Transportation Act, 49 App. U.S.C.A. §§ 1801-1819 (West 1976 & 1994 Supp.); and the Occupational Safety and Health Act Hazard Communication Standard, 29 C.F.R. § 1910.1200 (1993). 3. 7 U.S.C. § 136(u), ELR STAT. FIFRA § 2(u). 4. For a detailed discussion of FIFRA's jurisdiction, see infra, Part II. 5. Ch. 191, 36 Stat. 331. 6. Id. 7. Pub. L. No. 80-104, 61 Stat. 163 (1947). 8. Id. 9. See Pub. L. No. 88-305, 78 Stat. 190 (1964). 10. Reorganization Plan No. 3 of 1970, § 2(a)(8), reprinted in 5 U.S.C. app. at 1343, 1344 (1988) and 84 Stat. 2086 (1970). For delegation of authority over pesticides within EPA, see 40 C.F.R. § 1.43 (1993). 11. Pub. L. No. 92-516, 86 Stat. 973 (1972). 12. Pub. L. No. 94-140, 89 Stat. 751 (1975). 13. Pub. L. No. 95-396, 92 Stat. 819 (1978). 14. Pub. L. No. 100-532, 102 Stat. 2654 (1988). 15. Pub. L. No. 92-571, § 4(c)(2), 86 Stat. 973, 999 (1972). 16. Part IV.B.3, infra discusses me-too registrations. 17. §§ 1491-1499, Pub. L. No. 101-624, 104 Stat. 3359, 3627-32 (1990). 18. Pub. L. No. 102-237, § 1006, 105 Stat. 1818, 1894-97 (1991). 19. 7 U.S.C. § 136(u), ELR STAT. FIFRA § 2(u). The portion of the definition not quoted in the text excludes "new animal drugs" as defined by the Federal Food, Drug, and Cosmetic Act. See also 40 C.F.R. § 152.3(s) (1993). There are, however, a number of other substances that are subject to the jurisdiction of both EPA and the Food and Drug Administration (FDA) and that require approvals from both agencies. These are: * Products intended to sanitize food contact surfaces. See 21 C.F.R. § 178.1010 (1993); * Microbiocides used in paper and other packaging that comes into contact with food. See id. pt. 176; * Antimicrobial agents used on medical devices. FDA requires premarket notification for such products under § 501(k) of the FFDCA, 21 U.S.C. § 360(k); and * Substances used to control micro-organisms in cane- and beet-sugar mills. See 21 C.F.R. § 173.320 (1993). EPA and the FDA have entered a Memorandum of Agreement (MOA) and a Memorandum of Understanding (MOU) that outline which agency has primary jurisdiction for substances used on humans and animals. 36 Fed. Reg. 24234 (Dec. 22, 1971) (MOA); 38 Fed. Reg. 24233 (Sept. 6, 1978) (final regulation exempting from FIFRA certain products subject to the FFDCA); 44 Fed. Reg. 63749 (Nov. 5, 1979) (update to MOA); 48 Fed. Reg. 22799 (May 20, 1983) (MOU). In general, EPA has primary jurisdiction over disinfectants and sanitizers that do not claim disease control. The FDA generally has primary jurisdiction over products that control or relieve the effects of parasites, insect bites, diaper rash, athlete's foot, and certain animal diseases. 20. 7 U.S.C. § 136(t), ELR STAT. FIFRA § 2(t). EPA regulations elaborate on this statutory definition of "pest" and make clear that EPA has used its statutory authority to declare essentially all organisms to be pests "under circumstances that make [them] deleterious to man or the environment." 40 C.F.R. § 152.5 (1993). 21. 40 C.F.R. § 152.15 (1993). 22. Id. EPA takes a somewhat different approach to the intent element for purposes of determining when a chemical substance is exempt from TSCA because it is a FIFRA substance. 15 U.S.C. § 2602(2)(B)(ii), ELR STAT. TSCA § 3(2)(B)(ii). In interpreting this exemption, EPA has stated that it will find the necessary element of intent only when the pesticide producer has applied for an experimental use permit or for registration of the pesticide. Revisions of Premanufacture Notification Regulations, 51 Fed. Reg. 15096, 15098 (Apr. 22, 1986); Inventory Reporting Requirements, 42 Fed. Reg. 64572, 64585 (Dec. 23, 1977) (response to comment 38); see also 40 C.F.R. § 172.3 (1993) (discussing research and development activities that may be undertaken without an experimental use permit or a FIFRA registration). For a comprehensive guide to TSCA, see Carolyne Hathaway et al., A Practitioner's Guide to the Toxic Substances Control Act: Part I, 24 ELR 10207, 10211 (1994). 23. In re Chemco Indus., Inc., I.F. & R. VII-501C-83P, 1987 WL 50057, at *4-5 (EPA Jan. 24, 1984); see also In re Myers, I.F. & R. VII-344-C, 1980 WL 19379, at *5 (EPA July 31, 1980) ("the intended use of a product may be determined from its label, accompanying labeling, promotional material, advertising and any other relevant sources") (citing United States v. 216 Carton Bot., 409 F.2d 734, 739 (2d Cir. 1969)). 24. N. Jonas & Co. v. U.S. Environmental Protection Agency, 666 F.2d 829, 833, 12 ELR 20255, 20256-57 (3d Cir. 1981). 25. See 40 C.F.R. § 152.15(c), added in the final rule published in 53 Fed. Reg. 15952 (May 4, 1988). 26. 53 Fed. Reg. at 15954. 27. 40 C.F.R. § 152.8 (1993). 28. Id. § 152.10. 29. Id. 30. Id. § 172.3(a). 31. Id. 32. Id. § 172.3(b). 33. 40 C.F.R. § 152.30(c)(2) (1993). 34. R&D pesticides are subject to EPA's export labeling requirements. 40 C.F.R. § 168.65 (1993). They are subject to the purchaser notification requirements of the export policy, unless the export of the product would not involve more than 10 acres of land or one surface acre of water, and the product would not be used with food or feed crops, or water used for irrigation, drinking or recreation or animals used for food or feed. Id. § 168.75(b)(5)(i). These criteria apply to the total shipment in any one year to a particular country. Id. § 168.75(b)(5)(ii). The exporter bears the burden of demonstrating that the product meets these criteria prior to shipment. Id. § 168.75(b)(5)(iii). Export requirements are discussed in detail in Part X, to follow. 35. 58 Fed. Reg. 9062, 9066 (Feb. 18, 1993). 36. 58 Fed. Reg. 5878, 5881 (Jan. 22, 1993). 37. Id. at 5898. 38. Id. at 5899. 39. 7 U.S.C. § 136w(b), ELR STAT. FIFRA § 25(b). 40. 40 C.F.R. § 152.20 (1993). 41. The regulations, id., actually specifically exempt eucaryotic and procaryotic microorganisms and viruses, which fairly well covers the microbiological field. 42. Id. § 152.25. 43. EPA, CUSTOM BLENDS -- FIFRA COMPLIANCE PROGRAM POLICY No. 3.4 (May 10, 1982); see also EPA, CUSTOM BLENDS -- FIFRA COMPLIANCE PROGRAM POLICY No. 7.1 (May 10, 1982). 44. 7 U.S.C. § 136p, ELR STAT. FIFRA § 18; 40 C.F.R. § 152.30(e) (1993). Note that exempted pesticides still must comply with labeling requirements. Id. 45. 40 C.F.R. § 166.7 (1993). 46. Id. pt. 166. 47. Id. § 166.2. 48. Id. § 166.20. 49. Id. § 166.25. 50. Id. § 166.24. 51. 7 U.S.C. § 136p, ELR STAT. FIFRA § 18; 40 C.F.R. § 166.22 (1993). 52. 40 C.F.R. §§ 166.40, .45 (1993). 53. Id. § 166.43. 54. Id. § 166.41. 55. Id. § 152.30. 56. Id. § 152.30(a); 7 U.S.C. § 136a(b), ELR STAT. FIFRA § 3(b). 57. 40 C.F.R. § 152.30(b) (1993). 58. Id. § 152.30(c). For an explanation of experimental use permits, see infra Part IV.F. 59. 40 C.F.R. § 152.30(d) and pt. 168, subpt. D (1993). For a discussion of export requirements in general, see Part X.A, to follow. 60. Id. § 152.30(f) (1993). For a discussion of FIFRA regulation of disposal, see Part IX, to follow. 61. 7 U.S.C. § 136w(c)(4), ELR STAT. FIFRA § 25(c)(4). 62. See 40 C.F.R. § 153.240(b) (1993). 63. 7 U.S.C. § 136(h), ELR STAT. FIFRA § 2(h). 64. 40 C.F.R. § 153.240(a) (1993). 65. 40 Fed. Reg. 28242 (July 3, 1975). 66. 41 Fed. Reg. 51065 (Nov. 19, 1976). 67. Id. 68. EPA, GENERAL INFORMATION ON APPLYING FOR REGISTRATION OF PESTICIDES IN THE UNITED STATES 10-2 (2d ed. 1992). 69. Id.; 41 Fed. Reg. at 51065. 70. See Ruckelshaus v. Monsanto Co., 467 U.S. 986, 991, 14 ELR 20539, 20540 (1984) (FIFRA historically has focused on pesticide labeling). The 1972 amendments strengthened existing labeling requirements still further. Wisconsin Pub. Intervenor v. Mortier, 111 S. Ct. 2476, 2486, 21 ELR 21127, 21127 (1991). 71. "The term 'label' means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers." 7 U.S.C. § 136(p)(1), ELR STAT. FIFRA § 2(p)(1). 72. 7 U.S.C. § 136(p)(2), ELR STAT. FIFRA § 2(p)(2). This definition has been interpreted narrowly, so that additional warnings or instructions are not within the definition and thus are not preempted by FIFRA so long as they are aimed at persons other than end users. New York State Pesticide Coalition v. Jorling, 874 F.2d 115, 119, 19 ELR 20859, 20860-61 (2d Cir. 1989) (state-mandated warning and safety information, including signs posted on affected property and newspaper notifications of prospective pesticide use, are not labeling because they are meant to reach those who might happen upon the area or who contract to have pesticides applied, rather than end users); see also Wisconsin Pub. Intervenor, 111 S. Ct. at 2480, 21 ELR at 21127 (warning placards on property being treating with pesticides not labeling); Chemical Specialties Mfrs. Ass'n v. Allenby, 958 F.2d 941, 947, 22 ELR 20822, 20825 (9th Cir. 1990), cert. denied, 113 S. Ct. 80 (1992) (statute that required posting of point-of-sale warnings where pesticides sold held to be not labeling); Macrie v. SDS Biotech Corp., 630 A.2d 805, 812 (N.J. Super. Ct. App. Div. 1993) (warnings given to protect safety of those other than users not preempted). 73. 40 C.F.R. § 152.50 (1993). 74. Id. § 152.30. 75. 7 U.S.C. §§ 136j(a)(1)(E), 136(q), ELR STAT. FIFRA § 12(a)(1)(E), 2(q) (prohibition against misbranding and definition of misbranding). 76. Id. § 136(q), ELR STAT. FIFRA § 2(q). 77. See 40 C.F.R. pts. 152, 156 (1993). 78. EPA mails PR Notices to registrants of record when issued. Other persons may also obtain copies from EPA. 79. Persons may buy copies of the Bluebook from the National Technical Information Service. 80. 40 C.F.R. § 156.10(a)(1) (1993). 81. Id. § 156.10(g)(1). The percentage must be the ingredient's nominal concentration, which is defined as the amount of the ingredient "in a typical sample of a pesticide product at the time the product is produced." Id. § 158.153(i). Previously, the Office of Pesticides and Toxic Substances had allowed the label to display the lower certified limit, which is the percentage of the ingredient expected to be present at the end of a product's shelf life. See Notice to Manufacturers, Producers, Formulators, and Registrants of Pesticides, PR Notice 91-2 (EPA May 2, 1991). This change currently applies to all new registrants and those having products subject to reregistration; other currently registered products must comply with the notice by July 1, 1997. Id. 82. Under the statute, the Administrator has the authority after notice and an opportunity for hearing to "determine and establish suitable names to be used in the ingredient statement." 7 U.S.C. § 136w(c), ELR STAT. FIFRA § 25(c). 83. 40 C.F.R. § 156.10(g)(3) (1993). 84. Id. § 156.10(g)(4). 85. Id. § 156.10(g)(6). 86. Id. § 156.10(h)(1). FIFRA regulations call for the use of the signal words "DANGER," "POISON," "WARNING," and "CAUTION" to give a general sense of the toxicity of the pesticide. The most acutely toxic of pesticides (for which ingestion of only a few drops by mouth can prove fatal) must include the word "DANGER" on the front of the label; if the product qualifies for this most toxic of categories on the basis of oral, inhalation, or dermal toxicity, the label must also bear a skull and crossbones symbol, the word "POISON" in red on a contrasting background, id. § 156.10(h)(1)(i)(A), and a statement of practical treatment or first aid, Id. § 156(h)(1)(iii). EPA may allow the treatment statement to go on a back label if the front label refers to it clearly. Pesticides falling into the second highest toxicity category must bear the signal word "WARNING," id. § 156.10(h)(1)(i)(B); labels for pesticides less toxic to humans must include the word "CAUTION," id. § 156.10(h)(1)(i)(C). 87. Id. § 156.10(h)(1)(iv). The regulations require that the signal words be in capital letters and set out particular type sizes, which vary with the size of the label. Id. 88. Id. § 156.10(h)(2). 89. Id. § 156.10(h)(1)(ii). EPA may also waive this requirement if the product is approved for use on infants and small children. Id. 90. Id. § 156.10(h)(2)(ii). 91. Id. § 156.10(h)(2)(ii)(F). 92. Id. § 156.10(i)(1)(i). EPA can waive or modify the need for directions when the pesticide will only be used in industrial or health care applications by highly qualified users. Id. § 156.10(i)(1)(iii). 93. Id. § 156.10(i) 94. Id. 95. Id. § 156.10(i)(2). 96. Id. 97. 7 U.S.C. § 136j(a)(2)(G), ELR STAT. FIFRA § 12(a)(2)(G) ("It shall be unlawful for any person to use any registered pesticide in a manner inconsistent with its labeling"); see Sierra Club v. Mullen, 619 F. Supp. 1244, 1249, 16 ELR 20148 (D.D.C. 1985) (Drug Enforcement Administration's spraying paraquat on marijuana crops in known wildlife habitats was a use contrary to the express provisions of the EPA-approved pesticide label and thus a "clear violation of FIFRA."). 98. 7 U.S.C. § 136j(a)(1)(B), ELR STAT. FIFRA § 12(a)(1)(B). 99. Id. § 136a(d), ELR STAT. FIFRA § 3(d); 40 C.F.R. § 152.160 (1993). 100. See 40 C.F.R. §§ 152.160(b), 152.170 (1993). This Article discusses applicator certification in Part VI.B, to follow. 101. 40 C.F.R. § 156.10(j) (1993). 102. Id. § 152.168. 103. 49 Fed. Reg. 37960, 37966 (Sept. 26, 1984) (preamble to proposed regulations to be codified at 40 C.F.R. pts. 156, 167). 104. 40 C.F.R. § 152.160 (1993). 105. Id. § 156.10(j)(1). 106. Id. § 156.10(a)(2)-(3). 107. Id. § 156.10(a)(4); see also Aero-Master, Inc. v. U.S. Environmental Protection Agency, 765 F.2d 746, 746-47 (8th Cir. 1985) (manufacturer fined $ 2,100 for wiring label to handle of machine instead of "securely affixing" it as required by the relevant regulation). 108. 7 U.S.C. § 136(q)(E), ELR STAT. FIFRA § 2(q)(E); 40 C.F.R. § 156.10(a)(5)(viii) (1993). 109. 7 U.S.C. § 136(q), ELR STAT. FIFRA § 2(q); 40 C.F.R. § 156.10(a)(5) (1993). 110. 7 U.S.C. § 136j(a)(1)(E), ELR STAT. FIFRA § 12(a)(1)(E). A product or device also is misbranded if it falls under child-resistant packaging regulations (discussed infra in Part III.B) but does not conform to those standards. 111. For example, EPA fined a manufacturer $ 1,000 and prohibited it from selling its ultrasonic pest control device, the "RAT-I-CA-TOR," because the device's labeling claims about the effectiveness against rodents were not supported by test results. In re Electronics for Indus., Inc., I.F. & R. 04-8506-C, 1986 WL 69001, at *1 (EPA July 25, 1986); see also Notice of Intent to Cancel, 58 Fed. Reg. 41779 (Aug. 5, 1993) (announcing EPA's intent to cancel the registration of WipeOut Cold Sterilizing Disinfecting Solution for, inter alia, false and misleading claims constituting misbranding under FIFRA § 12(a)(1)(E) regarding the product's ability to sterilize or kill spores); In re Electronic Exterminators, Inc., I.F. & R. IV-384-c, 1981 WL 27904, at *2-3 (EPA Mar. 31, 1981) (Exterma Pulse Nofleez and Exterma Pulse Pest Control devices, the labeling of which claimed that the devices effectively controlled fleas and rodents, respectively, did not effectively control those pests and thus were misbranded). 112. Where a manufacturer of a roach bait failed to state limits on use to protect health or the environment, failed to list the ingredients on the front panel clearly distinguishable from other written parts of the label, did not state the percentage of active and inert ingredients, and did not include the required warnings concerning toxicological hazards, including dangers to children and the environment, EPA held it in violation of FIFRA's misbranding provisions. EPA v. Exsterex, Inc., I.F. & R. VI-210C, 1985 WL 57123, at *3-4 (EPA Aug. 23, 1985) (product also misbranded because labeling's statements that product designed to eliminate roaches was "a new concept in pest control: It is not a pesticide! … Ordinary pesticides can be dangerous," "contains all natural ingredients," and "because it is probably the safest possible solution to the roach problem, it can be used freely throughout a home or apartment" were false and misleading). 113. See U.S. EPA Settles Pesticide Labeling Complaint With LiphaTech, PR Newswire, Sept. 16, 1992 (describing consent decree in which LiphaTech, Inc. agreed to pay $ 10,000 after inspections revealed advertising and labeling claims for "Just One Bite" pesticide product were unfounded and misrepresented the product's efficacy, because the product was marketed in amounts too small to satisfy its claims that it would kill rats). 114. See 40 C.F.R. § 156.10(a)(5) (1993); see also Incentives for Development and Registration of Reduced Risk Pesticides, 57 Fed. Reg. 32140, 32141 (July 20, 1992); In re Farnam Cos., 96 F.T.C. 826 (1980) (consent order requiring manufacturer to cease representing through advertising or otherwise that its pesticide products are "absolutely or unqualifiedly safe, non-toxic or free of hazard to humans, pets, wildlife or the environment"). 115. See Incentives for Development and Registration of Reduced Risk Pesticides, 57 Fed. Reg. at 32141. 116. Id. 117. Id. 118. Id. California is trying a similar approach, allowing farmers to use EPA pesticides before California's studies are completed if the manufacture has shown that the pesticide would "provide a more benign alternative to a pesticide in use" and reduce the overall use of agricultural chemicals. New Law Speeds Use of Some Pesticides and Developing Regulations Seek to Cut Pesticide Emissions, 3 Shepard's Cal. Envtl. L. & Reg. Rep. 220 (Jan. 1994). 119. Advertising includes (1) brochures, pamphlets, circulars, and similar material offered to purchasers at the point of sale or by direct mail; (2) newspapers, magazines, newsletters, and other material in circulation or available to the public; (3) advertisements on broadcast media such as radio and television; (4) telephone advertising; and (5) billboards and posters. See 54 Fed. Reg. 1122, 1125 (Jan. 11, 1989) (preamble to regulations codified at 40 C.F.R. §§ 166.7, 168.22). 120. See 51 Fed. Reg. 24393 (July 3, 1986) (preamble to proposed regulations ultimately codified at 40 C.F.R. §§ 166.7, 168.22) (promotional material that accompanies a product as the product is sold or distributed, e.g., product inserts, is considered labeling, not advertising). Promotional material distributed to the public apart from the pesticide product is not considered labeling, even though it makes claims for the product. See In re Sporicidin Int'l, FIFRA-88-H-02, 1988 WL 236319, at *16, 18 n.31 (EPA Nov. 1, 1988). 121. See 7 U.S.C. § 136j(a)(1)(B), ELR STAT. FIFRA § 12(a)(1)(B) (unlawful to distribute or sell any registered pesticide if claims madeas part of pesticide's distribution or sale "substantially differ" from any claims made as part of the statement required for pesticide registration); see also In re Sporicidin Int'l, 1988 WL 236319, at *16, 18 n.31 (quoting letter from EPA regarding its regulation of pesticide advertising). 122. The task force was known as the Working Committee on Registration and Classification of the State FIFRA Issue Research and Evaluation Group. 123. See 54 Fed.Reg. 1122, 1125 (Jan. 11, 1989) (preamble to regulations to be codified at 40 C.F.R. §§ 166.7, 168.22). 124. 51 Fed. Reg. 24393 (July 3, 1986) (preamble to proposed regulations ultimately codified at 40 C.F.R. §§ 166.7, 168.22). 125. 40 C.F.R. §§ 166.7(b), 168.22 (1993); see also 54 Fed. Reg. 1122, 1125 (Jan. 11, 1989) (preamble to cited regulations, describing policy). 126. See 51 Fed. Reg. 24393 (July 3, 1986) (preamble to proposed regulations ultimately codified at 40 C.F.R. §§ 166.7, 168.22). 127. If a scientific journal article is later used in an advertisement, however, claims in the article may be treated as if made originally by the person placing the advertisement. See In re Sporicidin Int'l, 1988 WL 236319, at *16, 18 n.31. 128. See 40 C.F.R. § 152.46 (1993) (listing exceptions to general rule that labeling modifications require applying or amending registration). In addition, EPA may waive the requirement for submitting an application for amended registration, require that the applicant certify it has complied with an EPA directive rather than submit an application for amended registration, or let the applicant consolidate amendments affecting a number of products into one application. Id. § 152.44. 129. See Chemical Specialties Mfrs. Ass'n v. Allenby, 958 F.2d 941, 944, 22 ELR 20822, 20823 (9th Cir. 1990), cert. denied, 113 S. Ct. 80 (1992). 130. See 45 Fed. Reg. 37884 (June 5, 1980). 131. 7 U.S.C. § 136w(c)(3), ELR STAT. FIFRA § 25(c)(3). 132. The regulations governing the need for CRP are in 40 C.F.R. pt. 157, subpt. B (1993). 133. The only exception is oral toxicity, which is based on the average weight of a small child, the amount a child could easily ingest, and a safety factor of three; in this case, the requirement for CRP extends into Toxicity Category III. See 51 Fed.Reg. 21276 (June 11, 1986) (preamble to regulations to be codified at 40 C.F.R. pts. 157, 162). 134. 40 C.F.R. § 157.22(a)(6) (1993). 135. Id. § 157.21(e). 136. Id. § 157.22(b). 137. See 51 Fed. Reg. 21276 (June 11, 1986) (preamble to regulations codified at 40 C.F.R. pts. 157, 162). 138. Id. 139. Id. 140. 40 C.F.R. § 157.24(a) (1993); see also 51 Fed. Reg. 21276 (June 11, 1986) (preamble to regulations codified at 40 C.F.R. pts. 157, 162). The rule exempts large packages from CRP requirements based on EPA's expectation that the exemption will limit the accessibility of non-CRP-packaged pesticide products to clearly non-residential users while permitting continued unrestricted sale of CRP-packaged products. See id. (objective of protecting children from exposure to harmful toxic pesticides can be accomplished by requiring sizes normally distributed and sold to residential users to be in CRP while exempting larger sizes). To determine size criteria, EPA asked the American Association of Pesticide Control Officials to survey various types of retail establishments and identify the sizes of individually registered pesticide products available in retail establishments in which homeowners might be expected to buy pesticides. Id. 141. 40 C.F.R. § 157.24(b) (1993). 142. Id. § 157.24(b)(2). 143. Id. § 157.24(a)(1)(ii); see also 51 Fed. Reg. 21276 (June 11, 1986) (preamble of regulations codified at 40 C.F.R. pts. 157, 162). 144. 40 C.F.R. § 157.24(b)(4) (1993). 145. 7 U.S.C. § 136(q)(1)(B), ELR STAT. FIFRA § 2(q)(1)(B). For discussion of misbranding, see supra Part III.A.4. 146. 40 C.F.R. § 157.32(a) (1993). CRP packaging is designed so that children under age five find it "significantly" hard to open or obtain a toxic or harmful amount of pesticide from the pesticide products or devices so packaged. Id. § 157.21(b). The full CPSC standards are at 16 C.F.R. § 1700.15(b) (1993). 147. 40 C.F.R. § 157.22(b) (1993). 148. Id. § 157.22(c). 149. Id. § 157.34. 150. 7 U.S.C. § 136a, ELR STAT. FIFRA § 3. Prior to creation of EPA, the Department of Agriculture administered pesticide registrations. 151. Id. § 136a(c)(2)(B), ELR STAT. FIFRA § 3(c)(2)(B). 152. Id. § 136a(c)(5), ELR STAT. FIFRA § 3(c)(5). Registrations under § 3(c)(5) are called unconditional registrations to distinguish them from conditional registrations, discussed infra in this Part. 153. 7 U.S.C. § 136a(c)(5), ELR STAT. FIFRA § 3(c)(5). 154. See 40 C.F.R. § 158.640 (1993). 155. Id. n.1. 156. This standard actually is stated as two standards in the statute: "(C) [the pesticide] will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment." 7 U.S.C. § 136a(3)(c)(5)(C) & (D), ELR STAT. FIFRA § 3(c)(5)(C) & (D); see also 40 C.F.R. § 152.112(e) (1993). 157. 7 U.S.C. § 136(bb), ELR STAT. FIFRA § 2(bb). 158. Id. § 136a(c)(5), ELR STAT. FIFRA § 3(c)(5). 159. Incentives for Development and Registration of Reduced Risk Pesticides, 57 Fed. Reg. 32140 (July 20, 1992). 160. The Clinton Administration has also expressed a commitment to the reduction in the use of/risk of pesticides used for sustainable agriculture. EPA, FDA and USDA have cosponsored workshops on the Reduced Use Initiative in February and June 1994. 161. Montana Pole & Treating Plant v. I. F. Laucks, 775 F. Supp. 1339 (D. Mont. 1991), aff'd, 993 F.2d 676, 23 ELR 20843 (9th Cir. 1993). 162. 42 U.S.C. § 4332(2)(C), ELR STAT. NEPA § 102(2)(C). 163. Merrell v. Thomas, 807 F.2d 776, 18 ELR 21215 (9th Cir. 1986), cert. denied, 484 U.S. 848 (1987); cf. Wyoming v. Hathaway, 525 F.2d 66, 6 ELR 20169 (10th Cir. 1975), cert. denied, 426 U.S. 906 (1976); Environmental Defense Fund v. U.S. Environmental Protection Agency, 489 F.2d 1247, 4 ELR 20031 (D.C. Cir. 1973); Environmental Defense Fund v. Blum, 458 F. Supp. 650, 8 ELR 20748 (D.D.C. 1978). 164. 7 U.S.C. § 136a(c)(7), ELR STAT. FIFRA § 3(c)(7). 165. See 40 C.F.R. § 152.111 (1993) (EPA discretion to review new pesticide applications under the unconditional or conditional registration standards). 181. See supra Part II.B.2. 182. 40 C.F.R. § 152.43 (1993). 183. See 7 U.S.C. § 136a(c)(1)(C), ELR STAT. FIFRA § 3(c)(1)(C); 40 C.F.R. §§ 152.50(e), 156.10(i) (1993). 184. 40 C.F.R. § 152.15 (1993). 185. See supra Part II.B., 40 C.F.R. § 152.30 (1993) details the specific exemptions. 186. OPP, EPA, GENERAL INFORMATION ON APPLYING FOR REGISTRATION OF PESTICIDES IN THE UNITED STATES 6-16 (2d ed. 1992) (informally, "the Bluebook") (NTIS Order No. PB92-221811). 187. 40 C.F.R. § 152.3 (1993). 188. See infra Part IV.C. 189. See 40 C.F.R. § 152.113(b) (1993). 190. 7 U.S.C. § 136a(c)(3)(B), ELR STAT. FIFRA § 3(c)(3)(B); see infra Part IV.D.1.6. 191. 7 U.S.C. § 136a(e), ELR STAT. FIFRA § 3(e); 40 C.F.R. § 152.132 (1993). 192. 40 C.F.R. § 152.135 (1993). 193. See discussion infra in Part IV.E.3. 194. 7 U.S.C. § 136v(c), ELR STAT. FIFRA § 24(c). 195. 40 C.F.R. § 152.44 (1993). 196. Id. § 152.46(a). 197. Id. § 152.46(b). 198. 7 U.S.C. § 136a(c)(7)(B), ELR STAT. FIFRA § 3(c)(7)(B). 199. Id. 200. Id. 201. 40 C.F.R. § 152.55 (1993). 202. 7 U.S.C. § 136a(c)(4), ELR STAT. FIFRA § 3(c)(4); 40 C.F.R. § 152.102 (1993). 203. 7 U.S.C. § 136a(c)(3), ELR STAT. FIFRA § 3(c)(3); 40 C.F.R. § 152.110 (1993). 204. 40 C.F.R. § 152.105 (1993). 205. Id. 206. OPP, EPA (2d ed. 1992) (informally, "the Bluebook") (NTIS Order No. PB92-221811). 207. 40 C.F.R. §§ 158.35-.40 (1993). 208. Above the product manager level, for purposes of managing registrations, EPA has divided pesticides into three groups. Each group comes under the purview of a branch within the Registration Division. The Insecticide-Rodenticide Branch is responsible for pesticides used to control insects, mites, snails, and slugs, and vertebrate pests, e.g., rats, mice, and birds. This group of pesticides includes insect repellents and animal repellents, as well as biochemical and microbial insect control agents. The Fungicide-Herbicide Branch is responsible for substances used to control fungi, weeds, nematodes, and plant disease. This includes wood preservatives, desiccants, and plant growth regulators. The Antimicrobial Program Branch is responsible for pesticides used for disinfection, water treatment, and antifouling paints. This includes swimming pool chemicals, sterilants, and fumigants. Some products may be reviewed by more than one branch. Additional information on the classification of pesticides for registration purposes can be obtained by calling or writing the Registration Division of the EPA Office of Pesticides. 209. 7 U.S.C. § 136a(c)(3)(B), ELR STAT. FIFRA § 3(c)(3)(B). See supra Part IV.B.3. 210. 7 U.S.C. § 136a(c)(3)(B)(ii)(I), (II), ELR STAT. FIFRA § 3(c)(3)(B)(ii)(I), (II). 211. 40 C.F.R. §§ 152.102, .117 (1993). 212. Id. § 152.119. 213. 7 U.S.C. § 136a(c)(5),(7), ELR STAT. FIFRA § 3(c)(5), (7). 214. Id. § 136a(c)(6), ELR STAT. FIFRA § 3(c)(6); 40 C.F.R. § 152.118 (1993). 215. 7 U.S.C. § 136a(c)(6), ELR STAT. FIFRA § 3(c)(6); 40 C.F.R. § 152.118 (1993). 216. 40 C.F.R. § 152.118(e) (1993). 217. 40 C.F.R. pt. 164 (1993) contains the rules of practice governing these hearings. 218. Id. §§ 164.100-.111. 219. 7 U.S.C. § 136n(b), ELR STAT. FIFRA § 16(b). 220. Id. 221. 40 C.F.R. § 152.50(a) (1993). 222. 7 U.S.C. § 136a(c)(1)(A), ELR STAT. FIFRA § 3(c)(1)(A); 40 C.F.R. § 152.50(b) (1993). 223. 7 U.S.C. § 136a(c)(1)(B), ELR STAT. FIFRA § 3(c)(1)(B); 40 C.F.R. § 152.50(d) (1993). 224. 7 U.S.C. § 136a(c)(1)(D), ELR STAT. FIFRA § 3(c)(1)(D); 40 C.F.R. § 158.155 (1993). 225. 7 U.S.C. § 136a(c)(1)(C), ELR STAT. FIFRA § 3(c)(1)(C); 40 C.F.R. § 152.50(e) (1993). Labeling requirements are in id. pt. 156. 226. 7 U.S.C. § 136a(c)(1)(F), ELR STAT. FIFRA § 3(c)(1)(F); 40 C.F.R. § 152.50(f) (1993). 227. 40 C.F.R. § 152.50(c) (1993). 228. See infra Part IV.E.3 (discussion of use of previously submitted data). 229. This Article describes those requirements supra in Part III.B. 230. 40 C.F.R. § 152.50(g) (1993). 231. 7 U.S.C. § 136a(c)(1)(E), ELR STAT. FIFRA § 3(c)(1)(E). See the discussion of restricted use supra in Part III.A. 232. 40 C.F.R. § 152.160(a) (1993). 233. Id. § 152.50(h). 234. Id. § 152.50(i); see id. pts. 180, 185, 186. 235. Id. pt. 158. 236. In addition to the active ingredient, pesticide formulations commonly contain other ingredients with nonpesticidal functional purposes, such as solvents, surfactants, emulsifiers, humectants, perfumes, and so forth. 237. Id. §§ 158.35-40. 238. Id. §§ 158.150-.190. 239. See supra Part IV.D.2.c. 240. 40 C.F.R. § 158.175 (1993). 241. Me-too applicants generally can simply cite to data already in EPA's possession. 242. For a more complete list, see id. § 158.202. 243. For information, contact Kim Leighton at (703) 750-3000 or 1-800-2VERSAR. 244. 52 Fed. Reg. 13305 (Apr. 22, 1987). 245. 54 Fed. Reg. 48314 (Nov. 22, 1989). 246. This Article discusses data call-ins infra in Part IV.E.5. 247. 52 Fed. Reg. at 13308-09. 248. 40 C.F.R. pt. 160. 249. Id. §§ 160.1(a) (applicability to applications for research and marketing permits), .3 (definition of application for research or marketing permit). 250. Id. § 160.1(b). 251. Id. pt. 160, subpts, B, C, D, E, F, G. 252. Id. § 160.15. 253. Id. § 160.12. 254. Id. § 158.32; see also OPP, EPA, STANDARD FORMAT FOR DATA SUBMITTED UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) AND CERTAIN PROVISIONS OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (FFDCA), PR NOTICE 86-5 (July 29, 1986). 255. 40 C.F.R. § 160.185 (1993). 256. Id. § 158.32(b)(2)(ii). 257. Part IV.E.4. 258. 40 C.F.R. § 158.34 (1993). 259. Id. §§ 152.80-.98. 260. 7 U.S.C. § 136a(c)(1)(F)(i), ELR STAT. FIFRA § 3(c)(1)(F)(i). 261. Id. § 136a(c)(1)(F)(ii), ELR STAT. FIFRA § 3(c)(1)(F)(ii). 262. For legislative histories of the data compensation provision, see Ruckelshaus v. Monsanto Co., 467 U.S. 986, 14 ELR 20539 (1984); Amchem Prods. v. GAF Corp., 594 F.2d 470, 9 ELR 20610 (5th Cir. 1979); PPG Indus. v. Stauffer Chem. Co., 637 F. Supp. 85 (D.D.C. 1986). 263. Thomas v. Union Carbide Agric. Prods. Co., 473 U.S. 568, 15 ELR 20698 (1985); Ruckelshaus v. Monsanto Co., 467 U.S. 986, 14 ELR 20539 (1984); PPG Indus. v. Stauffer Chem. Co., 637 F. Supp. 85 (D.D.C. 1986). 264. PPG Indus., 637 F. Supp. at 88; Monsanto Co. v. U.S. Environmental Protection Agency, 564 F. Supp. 552, 561, 13 ELR 20561, 20566 (E.D. Mo. 1983), vacated on other grounds, 467 U.S. 986 (1984). 265. 29 C.F.R. pt. 1440 (1993). 266. See Union Carbide v. Thompson-Hayward Chem. Co., FIFRA Comp. Docket No. 27 (EPA, 1982) (initial decision); Stauffer Chem. Co. v. PPG Indus., Docket No. PPG Industries, Inc., 16 199 077 82 FIFRA (FMCS, 1983) (award); E. I. Du Pont de Nemours & Co. v. Griffin Corp., Docket No. 16-171-0080-86M (Am. Arb. Assoc., 1988) (award); American Cyanamide Co. v. Aceto Corp. Docket No. 13-171-0800-85 (Am. Arb. Assoc., 1989) (arbitrators' decision); Abbott Lab. v. Agtrol Chem. Prod., Docket No. 16-171-00536-89G (Am. Arb. Assoc. 1991) (arbitrator's decision and award). 267. 7 U.S.C. § 136a(c)(2)(D), ELR STAT. FIFRA § 3(c)(2)(D). 268. 40 C.F.R. § 158.50(b) (1993). 269. 7 U.S.C. § 136h, ELR STAT. FIFRA § 10. 270. Id. § 136h(a), ELR STAT. FIFRA § 10(a); 40 C.F.R. § 158.33 (1993). 271. 7 U.S.C. § 136h(b), ELR STAT. FIFRA § 10(b). 272. Id. § 136h(f), ELR STAT. FIFRA § 10(f). 273. Id. § 136j(a)(2)(D), ELR STAT. FIFRA § 12(a)(2)(D). 274. Id. § 136h(c), ELR STAT. FIFRA § 10(c). 275. Id. § 136h(b), ELR STAT. FIFRA § 10(b). 276. Id. § 136h(e), ELR STAT. FIFRA § 10(e). 277. Id. § 136h(d)(2), ELR STAT. FIFRA § 10(d)(2). 278. Id. § 136h(d)(1), ELR STAT. FIFRA § 10(d)(1). 279. Id. 280. Id. § 136h(d)(3), ELR STAT. FIFRA § 10(d)(3). 281. Id. § 136h(g). 282. 40 C.F.R. § 168.75(c)(2)(iii). 283. 40 C.F.R. pt. 2, subpt. B; see also id. § 2.307 (special rule concerning information obtained under FIFRA); id. § 2.308 (special rule concerning information obtained under FFDCA, i.e., pesticide tolerance information). 284. 40 C.F.R. § 2.101. 285. Id. § 136a(c)(2)(B)(i), ELR STAT. FIFRA § 3(c)(2)(B)(i). 286. Id. § 136a(c)(2)(B)(iv), ELR STAT. FIFRA § 3(c)(2)(B)(iv). 287. Id. § 136a(c)(2)(A), ELR STAT. FIFRA § 3(c)(2)(A). 288. Id. § 136a(c)(7)(C), ELR STAT. FIFRA § 3(c)(7)(C). 289. Id. § 136d(a)(2), ELR STAT. FIFRA § 6(a)(2). 290. See supra Part II.B. 291. 7 U.S.C. § 136c, ELR STAT. FIFRA § 5; 40 C.F.R. pt. 172 (1993). 292. 40 C.F.R. § 172.4(b) (1993). 293. Id. § 172.4(b)(3). 294. Id. pt. 158. 295. 7 U.S.C. § 136c(b), ELR STAT. FIFRA § 5(b); 40 C.F.R. § 172.4(b)(2) (1993). 296. 40 C.F.R. § 172.6(a)(1), (3) (1993). 297. Id. § 172.6. 298. Id. § 172.5(b). 299. 7 U.S.C. § 136c, ELR STAT. FIFRA § 5(c); 40 C.F.R. § 172.5(c) (1993). 300. Id. § 136c(d), ELR STAT. FIFRA § 5(d); 40 C.F.R. § 172.5(d) (1993). 301. 7 U.S.C. § 136c(e), ELR STAT. FIFRA § 5(e); 40 C.F.R. § 172.10 (1993). 302. 7 U.S.C. § 136c(f), ELR STAT. FIFRA § 5(f). 303. 40 C.F.R. §§ 172.20-.26 (1993). 304. 48 Fed. Reg. 44903 (Sept. 30, 1983) (Florida); 47 Fed. Reg. 18177 (Apr. 28, 1982) (Idaho); 47 Fed. Reg. 16096 (Apr. 14, 1982) (Vermont). 305. See 7 U.S.C. § 136a-1, ELR STAT. FIFRA § 4. 306. Id. § 136a-1(a), ELR STAT. FIFRA § 4(a). 307. Id. 308. See id. § 136a-1(c), ELR STAT. FIFRA § 4(c). 309. See id. 310. 54 Fed. Reg. 7740 (Feb. 22, 1989); 54 Fed. Reg. 22706 (May 25, 1989); 54 Fed. Reg. 30846 (July 24, 1989); 54 Fed. Reg. 43388 (Oct. 24, 1989). 311. 7 U.S.C. § 136a-1(e)(4), ELR STAT. FIFRA § 4(e)(4). 312. Id. § 136a-1(d)(2), ELR STAT. FIFRA § 4(d)(2). 313. Id. § 136a-1(d)(3), ELR STAT. FIFRA § 4(d)(3). 314. Id. § 136a-1(d)(4)(B), ELR STAT. FIFRA § 4(d)(4)(B). 315. See id. § 136a-1(d)(5), ELR STAT. FIFRA § 4(d)(5). 316. Id. § 136a-1(e)(1), ELR STAT. FIFRA § 4(e)(1). The reregistrant need not include all of the information that would be necessary for an initial registration if such information is on file with EPA and is current and accurate. 40 C.F.R. § 152.65 (1993). 317. OPP, EPA, FIFRA ACCELERATED REREGISTRATION -- PHASE 3 TECHNICAL GUIDELINES (Dec. 21, 1989); see also OPP, EPA, FORMAT STANDARDS FOR REREGISTRATION PHASE 3 SUMMARIES AND REFORMATTED VERSIONS OF STUDIES PREVIOUSLY SUBMITTED UNDER THE FEDERAL FUNGICIDE, INSECTICIDE, AND RODENTICIDE ACT (FIFRA) AND CERTAIN PROVISIONS OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (FFDCA), PR NOTICE 89-3 (Dec. 12, 1989); OPP, EPA, STANDARD FORMAT FOR DATA SUBMITTED UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) AND CERTAIN PROVISIONS OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (FFDCA), PR NOTICE 86-5 (July 26, 1986). The TECHNICAL GUIDELINES are a comprehensive guide to EPA's view of data requirements and are available from NTIS (Order No. PB90-161530). 318. 7 U.S.C. § 136a-1(e)(3)(B), ELR STAT. FIFRA § 4(e)(3)(B). 319. Id. 320. Id. 321. Id. 322. Id. § 136a-1(f)(1)(A), ELR STAT. FIFRA § 4(f)(1)(A). EPA completed this phase in 1993. 323. Id. § 136a-1(f)(1), (2), ELR STAT. FIFRA § 4(f)(1), (2). 324. Id. § 136a-1(f)(2)(B), ELR STAT. FIFRA § 4(f)(2)(B). 325. Id. § 136a-1(f)(3), ELR STAT. FIFRA § 4(f)(3). 326. Id. § 136a-1(g)(1), ELR STAT. FIFRA § 4(g)(1); see also 40 C.F.R. § 152.60 (1993). 327. 7 U.S.C. § 136a-1(g)(2)(A), ELR STAT. FIFRA § 4(g)(2)(A). 328. Id. 329. Id. § 136a-1(g)(2)(B), ELR STAT. FIFRA § 4(g)(2)(B). 330. Id. 331. See id. §§ 136a(c)(5), 136a-1(g)(2)(C), ELR STAT. FIFRA §§ 3(c)(5), 4(g)(2)(C). If EPA decides to reregister the pesticide, it is still free to take any other subsequent regulatory actions with respect to the pesticide. Report of the House Comm. on Agriculture, H.R. REP. No. 939, 100th Cong., 2d Sess. 30, reprinted in 1988 U.S.C.C.A.N. 3474, 3479. 332. See 7 U.S.C. § 136a-1(h), ELR STAT. FIFRA § 4(h); see also supra Part IV.E.3. 333. 7 U.S.C. § 136a-1(h), ELR STAT. FIFRA § 4(h). 334. See id. § 136a-1(i), ELR STAT. FIFRA § 4(i). 335. Id. § 136a-1(i)(4)(A), ELR STAT. FIFRA § 4(i)(4)(A). Antimicrobial active ingredients are also exempt provided that their production level does not exceed 1,000,000 pounds per year. Id. § 136a-1(i)(4)(B), ELR STAT. FIFRA § 4(i)(4)(B). 336. Id. § 136a-1(i)(7)(A), ELR STAT. FIFRA § 4(i)(7)(A). 337. Id. § 136a-1(i)(7)(B), ELR STAT. FIFRA § 4(i)(7)(B). 338. Id. § 136a-1(i)(7)(C), ELR STAT. FIFRA § 4(i)(7)(C). 339. Id. 340. Id. § 136a-1(i)(5)(A), ELR STAT. FIFRA §4(i)(5)(A). 341. Id. § 136a-1(i)(5)(C), ELR STAT. FIFRA § 4(i)(5)(C). 342. Id. § 136a-1(i)(5)(D), ELR STAT. FIFRA § 4(i)(5)(D). 343. Id. 344. Id. § 136a-1(i)(5)(B), ELR STAT. FIFRA § 4(i)(5)(B). 345. Id. § 136a-1(i)(5)(F), ELR STAT. FIFRA § 4(i)(5)(F). 346. 40 C.F.R. §§ 152.400-.414 (1993). 347. 7 U.S.C. § 136d(c)(1), ELR STAT. FIFRA § 6(c)(1). 348. Id. 349. Id. EPA must publish the notice in the Federal Register as well as contact the registrant by certified mail. Id. § 136d(f)(2), ELR STAT. FIFRA § 6(f)(2). 350. Id. § 136d(c)(1), ELR STAT. FIFRA § 6(c)(1). 351. Only the registrant may request an expedited hearing. See id.; 40 C.F.R. § 164.121(a) (1993). 352. 7 U.S.C. § 136d(c)(2), ELR STAT. FIFRA § 6(c)(2). 353. Id. Once the registrant has requested a hearing, any person "adversely affected by the notice" may move to intervene within five days after the registrant's receipt of the notice. 40 C.F.R. § 164.121(e). Leave to intervene will be granted if the intervenor will raise "matters which are pertinent to and do not unreasonably broaden the issues already presented," and will "raise matters or introduce evidence pertinent to the issue of imminent hazard which would substantially assist in its resolution." Id. §§ 164.31(c), 164.121(e). 354. 7 U.S.C. § 136d(c)(2), ELR STAT. FIFRA § 6(c)(2). 355. Id. 356. Id. § 136d(c)(3), ELR STAT. FIFRA § 6(c)(3); see Love v. Thomas, 858 F.2d 1347, 1350, 1363, 18 ELR 20368, 20369, 20376 (9th Cir. 1988) (although "imminent hazard" includes noncrisis situations in which there is a "substantial likelihood of serious harm" if an emergency order is not entered, EPA must find an "ongoing health hazard" before issuing an emergency suspension order), cert. denied, 490 U.S. 1035 (1989). 357. 7 U.S.C. § 136d(c)(3), ELR STAT. FIFRA § 6(c)(3). 358. Id; 40 C.F.R. § 164.123 (1993). 359. 7 U.S.C. § 136d(c)(4), ELR STAT. FIFRA § 6(c)(4). 360. Id. 361. Id.; see Love, 858 F.2d at 1364, 18 ELR at 20377 (district court must either uphold or stay the suspension; it may not "craft an alternative suspension order"). 362. 7 U.S.C. § 136d(c)(4), ELR STAT. FIFRA § 6(c)(4). 363. Id. § 136d(a)(1), ELR STAT. FIFRA § 6(a)(1). 364. Id. 365. Id.; see 56 Fed. Reg. 29362 (June 26, 1991) (Statement of Policy on Existing Stocks of Pesticide Products); see also National Coalition Against Misuse of Pesticides v. U.S. Environmental Protection Agency, 867 F.2d 636, 645, 19 ELR 20539, 20544 (D.C. Cir. 1989) (when there was an unsettled question with respect to a chemical's environmental effects, it was not unreasonable for EPA to enter a settlement agreement allowing for the continued sale of existing stock). 366. 7 U.S.C. § 136d(b), ELR STAT. FIFRA § 6(b). 367. See id. § 136(bb), ELR STAT. FIFRA § 2(bb). 368. Id. § 136d(b), ELR STAT. FIFRA § 6(b). 369. Id. 370. Id. 371. Id. 372. Id. 373. Id. § 136w(d), ELR STAT. FIFRA § 25. 374. Id. 375. Id. 376. Id. § 136d(b), ELR STAT. FIFRA § 6(b). If the notice mailed to the registrant is undeliverable, the law deems the applicant to have constructive notice on the day the notice appears in the Federal Register. Id. § 136d(f)(2), ELR STAT. FIFRA § 6(f)(2). 377. Id. § 136d(b), ELR STAT. FIFRA § 6(b); cf. Chemical Specialties Mfrs. Ass'n v. U.S. Environmental Protection Agency, 484 F. Supp. 513, 519-20, 10 ELR 20430, 20433 (D.D.C. 1980) (plaintiffs lacked standing to challenge EPA memorandum as constituting an undue burden on FIFRA registrants when the memorandum was merely an interpretive statement that created no new rights or responsibilities). 378. See 40 C.F.R. pt. 164 (1993). These same rules also govern administrative appeals of other EPA FIFRA actions, such as refusal to register a pesticide, suspensions, or amendments. 379. Id. § 164.20(a). 380. Id. § 164.20(b). 381. Id. § 164.8. 382. Id. § 164.23. 383. Id. § 164.24. 384. Id. § 164.50(b). 385. 7 U.S.C. § 136d(d), ELR STAT. FIFRA § 6(d); see also 40 C.F.R. § 164.70(a) (1993). 386. 40 C.F.R. § 164.80(a) (1993). 387. Id. § 164.80(b). 388. 7 U.S.C. § 136d(d), ELR STAT. FIFRA § 6(d). 389. Id. 390. See 40 C.F.R. § 164.101 (1993). 391. See 7 U.S.C. § 136n(b), ELR STAT. FIFRA § 16(b). 392. Id. 393. Id. 394. Id. § 136d(f)(1)(A), ELR STAT. FIFRA § 6(f)(1)(A). 395. Id. § 136d(f)(1)(B), ELR STAT. FIFRA § 6(f)(1)(B). 396. Id. § 136d(f)(1)(C), ELR STAT. FIFRA § 6(f)(1)(C). 397. Id. 398. Id. § 136d(f)(3)(A), ELR STAT. FIFRA § 6(f)(3)(A). Transfers are discussed in Part VI.B.4, to follow. 399. 7 U.S.C. § 136d(f)(3)(B), ELR STAT. FIFRA § 6(f)(3)(B). 400. Id. 401. Id. § 136d(f)(3)(D), ELR STAT. FIFRA § 6(f)(3)(D). 402. Id. § 136d(g)(1), ELR STAT. FIFRA § 6(g)(1). 403. Id. 404. Id. § 136d(a)(1), ELR STAT. FIFRA § 6(a)(1). 405. Id. § 136d(a), ELR STAT. FIFRA § 13(a). 406. Id. 407. Id. § 136q(a)(2), ELR STAT. FIFRA § 19(a)(2). 408. Id. § 136q(b)(1), ELR STAT. FIFRA § 19(b)(1). 409. See id. § 136m, ELR STAT. FIFRA § 15. 410. Id. § 136m(a)(3), ELR STAT. FIFRA § 15(a)(3). 411. Id. § 136m(a)(4), ELR STAT. FIFRA § 15(a)(4). 412. Id. § 136m(a)(2), ELR STAT. FIFRA § 15(a)(2). 413. Id. § 136m(b)(1), (3), ELR STAT. FIFRA § 15(b)(1), (3). 414. Id. § 136m(b)(1)(C), ELR STAT. FIFRA § 15(b)(1)(C). 415. Id. § 136m(b)(2), ELR STAT. FIFRA § 15(b)(2). 416. Id. 417. Id. § 136m(c)(1), ELR STAT. FIFRA § 15(c)(1). 418. Id. 419. Id. § 136m(c)(2), ELR STAT. FIFRA § 15(c)(2). 420. Id. 421. EPA may also evaluate concerns through investigating a registration and proposing changes or cancellations. 422. See 7 U.S.C. § 136a-1(g)(2)(C), ELR STAT. FIFRA § 4(g)(2)(C). 423. 40 Fed. Reg. 28242 (July 3, 1975). 424. 7 U.S.C. § 136a(c)(8), ELR STAT. FIFRA § 3(c)(8). 425. See 50 Fed. Reg. 12188, 12191-92 (Mar. 27, 1985). 426. 40 C.F.R. pt. 154, subpt. B (1993). 427. Id. § 154.7. 428. Id. 429. Id. § 154.7(a)(6). 430. Id. § 154.10. 431. Id. § 154.21. Once EPA gives private notice to registrants, it must establish a docket for the particular pesticide. Id. § 154.15(a). The docket must be available for public inspection and copying. Id. § 154.15(f). 432. 50 Fed. Reg. 12188, 12190 (Mar. 27, 1985); 50 Fed. Reg. 48998, 49008 (Nov. 27, 1985). 433. See 40 C.F.R. § 154.21 (1993). 434. See 50 Fed. Reg. at 49009-10. 435. 40 C.F.R. § 154.25(c) (1993). Under the regulations, EPA may shorten the process by simultaneously issuing the Notice of Special Review and the Notice of Preliminary Determination. Id. § 154.34. 436. Id. § 154.23. 437. Id. § 154.25(b). 438. Id. § 154.25(c). 439. A Notice of Special Review is usually supported by a "Position Document 1." 440. 40 C.F.R. § 154.26 (1993). 441. 7 U.S.C. § 136s(b), ELR STAT. FIFRA § 21(b); 40 C.F.R. §§ 154.27, .29 (1993). 442. 40 C.F.R. § 154.31(a) (1993). A detailed technical support document (commonly referred to as Position Document 2/3) discusses the rationale for the action being taken. This document combines Position Document 2, which discusses risks, and Position Document 3, which presents a use-by-use risk-benefit assessment. 443. Id. § 154.31(b). The USDA does not conduct any public process, although it does accept public input. The SAP, however, normally conducts a public meeting to receive input. 444. Id. § 154.33. A detailed Position Document 4 supports the final determination. 445. EPA Office of Inspector General, Report of Audit: Special Review Process for Pesticides (EPA July 22, 1993). 446. Id. 24 ELR 10449 | Environmental Law Reporter | copyright © 1994 | All rights reserved |