19 ELR 10070 | Environmental Law Reporter | copyright © 1989 | All rights reserved

1988 FIFRA Amendments: A Major Step in Pesticide Regulation

Editors' Summary: While the 1988 FIFRA Amendments are not the comprehensive reform package many had hoped for, the Amendments do address an issue at the heart of the pesticide program — EPA's reregistration of old pesticides. After unsuccessful attempts to amend FIFRA in 1982 and 1986, Congress passed a bill stripped of controversial issues such as groundwater contamination and farmer liability for contamination resulting from lawful pesticide use. However, the 1988 Amendments greatly accelerate the pace of EPA's reregistration program, under which the safety of older pesticides registered under now obsolete testing methods is reevaluated. The new law also helps ensure that EPA will have the money to implement the program by establishing reregistration fees, limiting the government's indemnification obligations for stocks of banned pesticides, and requiring registrants to assume most of the responsibility for the storage and disposal of banned pesticides. The authors review the origin of the "old pesticides" problem and describe how the Amendments will accelerate the reregistration program. They conclude that the Amendments could speed the abandonment of certain useful pesticide products, especially older products that require significant additional testing, but will provide greater assurance that pesticides do not present unacceptable risks to human health and the environment.

Mr. Ferguson is Vice President-General Counsel of the National Agricultural Chemicals Association (NACA). Mr. Gray is a senior attorney in EPA's Pesticides and Toxic Substances Division. The views expressed in this Article are solely those of the authors and do not necessarily reflect the views of NACA or EPA.

[19 ELR 10070]

The sale and use of pesticides in the United States is regulated by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).¹ In recent years EPA has come under heavy criticism for the slowness of its "registration" program, under which the data supporting the registrations of "old" pesticides are updated and the safety of those products is reevaluated.²

In October 1988, President Reagan signed into law a package of FIFRA amendments³ that are designed to speed up reregistration and remove potential threats to EPA's budget that could thwart its efforts to protect the public. The new law directs EPA to complete reregistration by 1977, at least ten years earlier than would have been required without the amendments.⁴ This expedited reregistration requirement and the financial commitment to make it possible were viewed in Congress as the most important provisions of the 1988 Amendments.⁵

The 1988 Amendments, however, have received only a lukewarm reception. Critics have dubbed the changes "FIFRA Lite" and "another excuse to postpone important issues."⁶ We think the 1988 Amendments will prove to be extremely significant. This Article will try to explain why.

There is widespread agreement among those involved in pesticide matters that prompt completion of the reregistration effort is urgently needed.⁷ Whether one believes that [19 ELR 10071] pesticides pose a dangerous threat to the public and should be stringently regulated or banned,⁸ or that pesticides are essential tools that are safe when used as directed, no one argues that pesticides are risk-free or should not be well tested. So long as there are pesticides in use that have not been subjected to modern testing and evaluation, there will be concern that pesticides are causing health or environmental problems. Much of the public is, rightly or wrongly, highly concerned about perceived pesticide risks. In introducing legislation that formed the basis of the 1988 Amendments, Senator Leahy spoke for many people in saying:

Pesticides are a serious public health hazard. American farmers, consumers and businesses use over 1 billion pounds of pesticides a year on their homes, farms, and businesses. Many of these pesticides are used with little or no knowledge of their long term toxic consequences. Pesticides are in the air we breathe, the food we eat and the water we drink …. In the face of these facts, it is clear that government is not doing its job. Public health has not been adequately protected.⁹

Over the past several years pesticide manufacturers, farmers and other major commercial users of pesticides, and food manufacturers and distributors increasingly have come to appreciate the dimension of this public concern. They have come to realize that the pesticide furor will not abate so long as critics can claim persuasively that some pesticides in use have not been adequately tested.¹⁰

The Origin and Growth of the "Old Pesticides" Problem

Lack of Attention to New Data Requirements for Old Pesticides Under Early Versions of FIFRA

At the core of FIFRA is the requirement that each pesticide must be reviewed by EPA and receive a registration prior to its commercial marketing.¹¹ This concept has been a part of pesticide regulation for over 40 years.¹² But this basic registration requirement, with its emphasis on premarket approval, does not work well as a means for acquiring new data on already marketed products.

Obtaining a registration requires the filing of an application, supported by information describing the composition and labeling of the particular product for which registration is sought and, usually, by data on potential risks.¹³ Data may be required both on the product's active ingredients and formulations.¹⁴ If EPA's evaluation of the application and supporting data indicates that the pesticide may be used without causing "unreasonable adverse effects on the environment,"¹⁵ the registration is approved, thus allowing the product to be sold and used for the purposes specified on the labeling.

In the early years of FIFRA, the data requirements for product registration were modest, but they have grown exponentially as more has been learned about potential hazards and methods to test for these hazards.¹⁶ All pesticides must satisfy applicable requirements for data when they are first registered. The ongoing changes in the data requirements, however, sometimes leave even recently registered products with "data gaps" after a short time. This contributes to the public perception that most pesticides in use are inadequately tested and potentially unsafe.

While stringently regulating the entry of new products on the market through registration, until the 1978 amendments the law only casually addressed how pesticides, once registered, should have their supporting data bases updated to meet current standards.¹⁷ For many years, the main duty [19 ELR 10072] of EPA (and the Department of Agriculture before it) was to react to registration applications. A registration application would trigger EPA action to register the product, encouraged further by the registrant's interest in bringing the product quickly to market. Similarly, the EPA could take action to cancel a pesticide's registration if EPA became aware of a significant product risk.¹⁸ Products that were neither new nor in question received much less attention.¹⁹

The 1972 Amendments Introduce Classification and Require Reregistration

Congress comprehensively rewrote FIFRA in 1972, reacting to concerns about risks to food consumers and to the environment from persistent pesticides that posed chronic hazards, and to concerns about acute toxicity risks to pesticide users and farm workers. It also responded to the concerns of farmers and pesticide registrants that the prior law seemed to allow no middle ground between cancelling the registration of a pesticide despite its benefits, and continuing its registration despite its risks.

In an attempt to reconcile these conflicting concerns, Congress directed EPA to develop regulations under which all registered pesticides would be "classified" for either "restricted use" by trained, certified applicators, or for unrestricted "general use" by anyone.²⁰ EPA was to have developed these regulations by October 1974, and during 1974-1976 was expected to "reregister" the existing pesticides.²¹ By including in FIFRA a provision that equated "reregistration" with "registration,"²² Congress [19 ELR 10073] purported to incorporate into this reregistration step all the provisions regarding data submission, data evaluation, and approval criteria that were to apply to applications for new registrations.²³

Some 30,000 to 60,000 existing products — estimates vary over this range — were subject to the classification and reregistration requirements. If Congress expected in fact that all the data bases could be updated, all the old and new data reevaluated, and all the products reregistered by 1976, as if for the first time, that expectation was wildly over-optimistic.²⁴ For its part, EPA's attempts to implement the 1972 law were marked by a slow start, conflicting signals about the scope of the undertaking, and a belated recognition of the impossibility of completing the needed work in anything approaching the time allotted.²⁵

EPA originally envisioned reregistration as primarily a process of reviewing existing product labels and summary files (supplemented in some cases by review of newly submitted short-term studies), correlating information on the toxicity and use patterns of groups of related products, and requiring the label changes or other actions indicated by these evaluations and by the criteria EPA developed for "restricted use."²⁶ Missing long-term studies would be requested, but reregistration would not await their completion.²⁷ Needed new data on environmental fate and ecological effects would be treated in the same way.²⁸

While EPA was later criticized severely for its early failure to emphasize the review of previously submitted studies to determine which required data had never been submitted or needed to be replaced,²⁹ merely identifying the data gaps would have posed a huge challenge to the Agency in the early- and mid-1970s, shortly after it inherited the FIFRA program from the Department of Agriculture. EPA first published its regulations establishing the data requirements for various types of pesticides in 1975.³⁰ Before 1975, the Agency had only incomplete internal guidance on what data were needed. EPA also lacked a usable catalog of the various studies that had been submitted.³¹ Moreover, the statute did not contain a good mechanism for requiring the submission of data by pesticide registrants once the need for the data was identified.³²

In addition to problems related to identifying and filling data gaps, the Agency faced other problems growing out of the statute's structure. The 1972 law failed to create any special procedures to be used to conduct reregistration.³³ EPA thus had to create by regulation, with virtually no congressional guidance, a process for the orderly processing of thousands of products.

The situation was also complicated by the 1972 statute's somewhat confused and incomplete treatment of a registrant's property rights in its data and of trade secrecy.³⁴ Companies [19 ELR 10074] submitting studies claimed that the Agency could not rely on their studies in evaluating a competitor's product for reregistration, despite the scientific relevance of the studies to the competing product. They also asserted on trade secrecy grounds that EPA could not allow anyone outside the government — whether a competitor or a concerned special interest group — to review their studies. These data use and disclosure isues were the subject of legislative amendments in 1975 and 1978 and of a series of court cases beginning in the early 1970s that were finally resolved by Supreme Court rulings in 1984 and 1985.³⁵

Notwithstanding these problems, in 1975 and early 1976 EPA finally published its plan for accomplishing reregistration.³⁶ The plan was based on the critical assumptions that the existing data in its files accurately reflected the results of properly conducted studies, the data had been reviewed thoroughly when received, and any adverse effects disclosed by the review already had been duly noted and made the subject of appropriate regulatory action.³⁷ If data gaps were found, the Agency expected to "conditionally reregister" products and to receive and review the data later.³⁸ In 1976, however, the Agency discovered that all the assumptions upon which this strategy rested were flawed. Widespread fraud in the conduct of studies by one of the major independent toxicity testing laboratories came to light,³⁹ and a survey of old government reviews of submitted data raised serious doubts about the quality of many of those reviews and the thoroughness of the Agency's follow-up on adverse effects.⁴⁰

Congress Reacts: The 1978 Amendments

EPA halted its reregistration effort in mid-1976 and went to Congress to ask for help. The Agency explained that the combination of the structural problems in the statute itself and the work involved in reevaluating all of the old data meant that the reregistration process would be substantially more demanding than had been expected and would take ten years or more to complete.⁴¹

The resulting 1978 amendments cut the linkage with classification that originally had given reregistration its importance and eliminated any deadline for completion of the reregistration effort, instead directing that it be finished as soon as practicable.⁴² The amendments also gave the Agency important new authority to require data submissions, to provide for registrants to share the cost of data generation, and to suspend the registrations of products if registrants failed to respond to test data requirements in a timely fashion.⁴³ In addition, Congress eliminated a "double standard" for old and new registrants by providing for conditional registration of similar products,⁴⁴ adopted sweeping changes in the provisions governing use and disclosure of data,⁴⁵ and directed the Agency to focus on active ingredient data to expedite registrations.⁴⁶

These amendments removed all the structural problems in the statute that had doomed EPA's first attempt at reregistration. In 1979, the Agency published a general description of how it would proceed.⁴⁷ With some modifications, this approach to reregistration has been used ever [19 ELR 10075] since. The approach has two main stages: first, available information on an active ingredient is gathered and reviewed by EPA to develop an initial "registration standard" that identifies needed studies and requires registrants, through a "data call-in," to perform them and submit the results.⁴⁸ The initial standard also states the regulatory conclusions that can be made on the basis of the data reviews. Second, after registrants submit the data, the Agency conducts a complete data review, issues a final standard, and takes appropriate action on the affected registrations. EPA has completed the first-stage review on almost 200 active ingredients, including most of the major agricultural-use chemicals, and has finished several second-stage standards.⁴⁹ This basic reregistration procedure of data review, data generation, and reassessment is reflected in the 1988 amendments.

Continuing Criticism of the Pace of Reregistration Leads to Further Legislative Action

Despite this steady progress on reregistration, criticism increased during the early 1980s about the pace of the program. The major barrier to quicker action was money. Additional resources were necessary even to continue the pace of 25 new first-stage standards per year, while conducting the second-stage reviews on a growing avalanche of data generated by registrants responding to EPA's data call-in requirements.⁵⁰ Speeding the process beyond 25 standards per year in response to this criticism was impossible without a major infusion of funds. The growing national concern with government expenditures and taxes, however, made it clear that additions to EPA's budget for pesticide reregistration would not be forthcoming.⁵¹ Moreover, as EPA continued to expand the data requirements, the backlog — in terms of both needed studies not yet submitted and submitted studies requiring review — was increasing correspondingly.

Much of the criticism in the early 1980s continued to be directed at the problem of "old" pesticides. A report from the National Academy of Sciences in 1984 asserted that there were sufficient health and safety data for complete hazard assessments on only 10 percent of the pesticides in use.⁵² Other congressional studies concluded that EPA's approach to reregistration was plagued with delays and problems.⁵³ These reports, along with highly publicized discoveries of pesticide residues in food and water⁵⁴ and complaints of EPA bias and irregularities in development of registration standards,⁵⁵ continued to shake the public's faith in the capacity of EPA to protect it from pesticide hazards. As a result of these concerns, there were demands in the early 1980s for statutory reform, and unsuccessful attempts to amend FIFRA were made in 1982 and 1986.⁵⁶

While many factors may have contributed to the passage of the 1988 FIFRA amendments, the 1985 negotiations between the agricultural pesticide industry and environmentalists were an important catalyst. In the fall of 1984 and early 1985, a group of environmental and consumer advocates were able to convince House and Senate Judiciary Committee leaders to defer an industry-sponsored patent law amendment until legislative action was taken on FIFRA.⁵⁷ As a result of this development — which the pesticide industry called "blackmail"⁵⁸ — the National Agricultural Chemicals Association (NACA) commenced negotiations in early 1985 to obtain the release of its legislation.⁵⁹ Over the succeeding six months, NACA and the Coalition for Pesticide Reform (CPR),⁶⁰ representing over 40 environmental, consumer, and labor groups, developed [19 ELR 10076] a package of amendments that were, along with others, incorporated into proposed legislation introduced in 1985.⁶¹

The NACA-CPR legislative initiative ultimately failed in late 1986, although the package of amendments passed both the House and Senate in different forms by overwhelming votes.⁶² While identical in most respects, the differences between the versions remained unresolved and the final House version was never considered in the Senate's concluding days.⁶³ The agreement that resulted from the NACA and CPR negotiations was called "historic" and "extraordinary," and helped to shape the final 1986 amendments.⁶⁴ Yet the reregistration schedule and related fees were the only parts of the compomise that succeeded in becoming law in 1988.

Senate hearings in early 1987 on FIFRA amendments confirmed that the once focused backing for FIFRA reform had dissolved. Issues that had blocked passage of the 1986 bill still lingered and interests on all sides questioned the wisdom of continuing their earlier commitments. What the environmental interests earlier had supported was now termed by some of them "a monster" and "a deal with the devil."⁶⁵ While NACA still professed support for the 1986 amendments, most of the industry did not press for reopened negotiations to resolve remaining problems. Agriculture and food industry interests reconsidered the need for FIFRA reform, even though they greatly desired uniform tolerances and farmer liability amendments.⁶⁶ As the deadlock continued throughout 1987 and early 1988, the Congressional leadership wisely decided in late summer of 1988 to move a bill stripped of all but essential elements. The resulting bill was passed by the House and Senate by mid-October, and signed by President Reagan on October 25, 1988.

The 1988 Amendments and Their Significance

The 1988 Amendments do not change the basic standards that determine what pesticides may be marketed, and make only modest changes in the basic procedures that EPA used to regulate pesticides. Indeed, the most important parts of the Amendments are those that, on a superficial reading, appear simply to set procedures for reregistration, provide money, and allow EPA to do other tasks related to reregistration and regulation of older products. In introducing the amendments, Senator Leahy briefly summarized the bill as follows:

It includes provisions that would provide for: First, reregistration, or reexamination, of hundreds of older pesticide products; second, industry-generated fees to pay for the work; and third, transfer of the financial responsibility for storage and disposal of suspended and cancelled pesticides and for reimbursement of pesticide manufacturers from EPA and the taxpayers to pesticide manufacturers.⁶⁷

These ostensibly mundane amendments actually go to the heart of the problem bedeviling pesticide regulation: what to do about old pesticides. The infusion of funds, different allocation of work between EPA and registrants, and protection of EPA financial resources should allow the Agency to accelerate dramatically the reregistration process and direct its energies to other important aspects of pesticide regulation. Also important are changes in the procedures for dealing with the recall, storage, and disposal of these older products when cancellation or the demands of reregistration force than off the market.

The Provisions of the New Law: A Focus on Resources

Reregistration Fees: The 1988 amendments respond to the call for prompt completion of reregistration in precisely the needed way — by providing substantial amounts of money and by protecting the Agency's existing budget from debilitating diversions. The amendments permit EPA to levy two different types of fees to provide sufficient financial resources to conduct reregistration. These resources should exceed $ 150 million over the nine-year life of the reregistration program.⁶⁸ A one-time "active ingredient fee," borne by basic producers of products identified for reregistration, ranges from $ 150,000 for major food and feed use pesticides to nothing for pesticides used only for minor uses.⁶⁹ EPA is also authorized to collect an annual [19 ELR 10077] "maintenance fee" — nominally $ 425 — on each reregistration.⁷⁰

Reregistration Schedule: In addition, the reregistration amendments set an ambitious and detailed schedule designed to guide registrants and EPA through reregistration. This is a long and complex process of identifying weaknesses in the scientific data supporting each product registered before 1984,⁷¹ generating data necessary to the product's continued use, evaluating the data, and making a final administrative decision. Although spelled out in more detail, the process is in many ways similar to EPA's current approach. The complete process of reregistration defined in the 1988 law covers five phases, applied in turn to three different groups of active ingredients:⁷²

Phase One: EPA must publish a priority list of the pesticide active ingredients to be reregistered.⁷³

Phase Two: Registrants are required to notify EPA whether they intend to seek reregistration. Those who reply positively must identify and agree to replace missing or inadequate data, and pay the first installment of the active ingredient fee. EPA may cancel registration if the registrant does not state that reregistration will be sought.⁷⁴

Phase Three: Registrants are required to summarize certain studies submitted in support of the registration, reformat data in the studies according to EPA's guidelines, commit to fill outstanding data requirements, and pay the final installment of the active ingredient fee.⁷⁵

[19 ELR 10078]

Phase Four: The Administrator is required to review submissions of data and other materials to determine if all missing or inadequate data were identified, and identify, publish, and require submission of any outstanding data requirements.⁷⁶

Phase Five: EPA is required to conduct a thorough examination of all data and determine if the active ingredient is eligible for reregistration. All applicants for reregistration are then required to supply necessary product-specific data. The Administrator is obligated to make a final decision on reregistration not later than one year after the submission of all required data.⁷⁷

While similar to EPA's earlier registration standards process, the amendments include a dramatic restructuring of administrative burdens and, consequently, the costs of reregistration. The law formerly placed the administrative task of reregistration squarely on EPA. The Agency had to establish registration criteria, review data already submitted by registrants, identify data gaps, require registrants to submit missing and inadequate data, review the data when received, and finally reregister, change, or cancel the product's registration. The new law shifts to registrants many of these tasks. EPA is still charged with deciding whether data gaps exist, reviewing all data, and making a final regulatory assessment, but the Agency's task will be made considerably easier and less costly to it by the preliminary work of registrants.

The middle three phases of the new five-phased procedure do not apply to the 200 or so active ingredients for which initial registration standards have been previously issued. EPA has already identified data required for such pesticides and has set schedules for the submission of the data. But EPA's ability to promptly complete its reviews of these chemicals — which together comprise most of the important agricultural-use pesticides and largest volume of the pesticides marketed — will be enhanced greatly by the new law, simply because the funds made available can be used to help pay for the needed reviews.

Idemnification: Before the 1988 amendments, FIFRA required EPA to make indemnity payments for economic losses suffered by holders of a pesticide whose registration was suspended and cancelled.⁷⁸ The indemnity provision, added in 1972, was designed to protect holders of registered products that the EPA must quickly act to ban.⁷⁹ This relief was seen as particularly important for agricultural pesticides, inventories of which would be very large at certain times in anticipation of seasonal needs. Indemnity has become a serious problem for EPA in the last few years. Claims received for indemnity payments to producers, distributors, and others for two suspended and cancelled chemicals, 2, 4, 5-T/silvex and ethylene dibromide (EDB), totalled more than $ 30 million. Since the annual operating budget for its pesticide program is only about $ 60 million, this obligation has posed a considerable threat to the Agency's resources, although most of these claims were eventually paid from sources other than EPA's operating budget. Registrations of a third chemical, dinoseb, were suspended in October 1986 and recently cancelled. The indemnification costs for these products are anticipated to be as high as $ 40 million.⁸⁰

The amendment addresses this financial threat by changing the terms under which the holder of a suspended and cancelled pesticide will be reimbursed by the federal government. "Automatic" indemnification is limited to end users and is to be paid out of a general appropriation, the so-called "Judgment Fund," reserved for paying claims against the federal government.⁸¹ Dealers and distributors [19 ELR 10079] holding suspended or cancelled products may be eligible for federal indemnification only if the company selling the pesticide is bankrupt and did not notify the dealer or distributor that it would not give reimbursement for the product upon suspension or cancellation.⁸² Registrants and pesticide producers can be indemnified under the statute only if funds are specifically appropriated by Congress for that purpose.

The amendments to FIFRA's indemnification provisions were designed to relieve the federal government, and EPA in particular, of what Congress and others saw as excessive and unfair financial demands. With respect to EDB indemnification and disposal, Representative Synar commented:

Already the diversion of program funds for EDB disposal is irrevocably compromising EPA's initiatives to identify and accelerate the suspension of other unsafe pesticides. We are spending enormous sums of taxpayers' money while jeopardizing the health and welfare of our farmers and agricultural consumers …. [T]he system is broke and needs fixing. But before we call the repairman, we need to ask one vital question: Why is the taxpayer being tagged to pay disposal costs and reimburse pesticide producers for products that are found to present an imminent public health hazard, when we do not do so for any other industry?⁸³

Although earlier congressional action already had temporarily removed the indemnity burden from EPA's operating budget,⁸⁴ there remained a perception in Congress that this unique benefit accorded pesticide registrants and their customers should no longer be provided at taxpayer expense.⁸⁵ Perhaps more importantly to some, the amendment removed the possibility that having to make indemnity payments would discourage EPA from aggressive regulation.⁸⁶ Especially in this last respect, the changes to indemnification were a natural extension of the expedited reregistration program's potential to result in suspension and cancellation of some registrations.

Recalls, Storage, and Disposal: Prior to the 1988 amendments, FIFRA also required EPA to "accept for safe disposal," on request, pesticides whose registrations were suspended and cancelled. Disposal actions for three products on which EPA has recently acted — 2, 4, 5-T/silvex, EDB, and dinoseb — have been very expensive.⁸⁷ To eliminate this EPA expense, and to remedy what was perceived to be another windfall for registrants similar to indemnification, the 1988 Amendments shifted the responsibility for disposal — and most of the financial burden of this responsibility — to the pesticide industry. The result will likely be a significant government savings and benefit EPA in much the same way as the amendments to FIFRA's indemnity provisions.⁸⁸

A second important change provides EPA with enforceable authority to require holders of cancelled pesticides to dispose of the products and to specify the means of disposal.⁸⁹ Under the amended FIFRA, these directives may be issued by regulation or as part of a cancellation order.⁹⁰ The Agency has great discretion: the statute broadly authorizes EPA to "issue requirements and procedures for the disposal of any pesticide the registration of which has been cancelled." However, the law disclaims any intention of overriding the Resource Conservation and Recovery Act and contains no express preemption of state authority to regulate disposal.⁹¹

[19 ELR 10080]

These amendments also establish new authority for EPA to require recalls of pesticides whose registrations have been suspended and cancelled. Upon a finding that a recall is "necessary to protect public health or the environment," the Agency must order either a "voluntary" or "mandatory" recall.⁹² If EPA finds that a voluntary recall "may be as safe and effective as a mandatory recall," the Agency mustrequire the registrant or registrants of the product to submit a voluntary recall plan within 60 days.⁹³ If EPA initially rejects the idea of a voluntary recall or if a proposed voluntary plan fails the statutory criteria, the amendments require that EPA issue a regulation that prescribes a mandatory recall plan.⁹⁴

Voluntary recall plans may vary with respect to the activities that are included, so long as prescribed standards of safety and efficacy are satisfied.⁹⁵ Mandatory plans, implemented by regulations, may specify storage, transportation, and other requirements. Storage costs — but not transportation or disposal costs — incurred by a registrant under either a voluntary or a mandatory plan are to be partially reimbursed by the federal government.⁹⁶

Finally, Congress required EPA to issue regulations aimed at avoiding or lessening the problems associated with pesticide disposal in the first instance. The Agency must issue within three years (and enforce within five years) regulations for the design of pesticide containers to aid storage and disposal and for the removal of pesticides from containers prior to disposal. EPA is also instructed to conduct a study of options to facilitate or require container recycling, rinsing, and use of bulk storage.⁹⁷

Why the Amendments Are Important

The amendments will be important in changing the pesticide industry and the products it sells. Most evident will be the loss and abandonment of products, perhaps as much as one-third of current registrations.⁹⁸ This reduction is already occurring under EPA's registration standards program; the 1988 Amendments will make it happen more quickly.

This loss of products will result primarily from the cost of reregistration testing. Certainly some products will be lost because studies show a health or environmental problem, or because registrants decide to abandon products outright in anticipation of unfavorable study results. But many products will be lost merely because of the cost of testing required by reregistration. These testing costs inevitably will be considerable.⁹⁹ While the amendments do [19 ELR 10081] not modify the tests required for registration,¹⁰⁰ they require tests sooner and concentrate them within a shorter period. The previous pace of testing will double, with important consequences.

The concentrated reregistration schedule will increase demands on the capacity of available testing facilities and may increase per-test costs. These cost increases, and the accelerated pace of testing called for by the expedited schedule, will force registrants to make early, hard decisions on whether they wish to continue marketing certain pesticides. Many useful products will disappear, not necessarily because they are unsafe. This attrition will be especially visible among older products that require significant additional tests, but whose sales are inadequate to support the added costs. For most active ingredients used in food production, the major decisions about data generation have already been made as a result of the registration standards program, and weaker products have already been abandoned.¹⁰¹ The expedited testing schedule imposed by the new law is most likely to have a significant impact on the 400 or more remaining active ingredients used outside of agriculture, those used in homes, industry, and institutions.

Throughout deliberations on the 1988 Amendments, pesticides producers and consumers alike were fearful that reregistration fees would make some pesticides uneconomical and cause products to be abandoned.¹⁰² While this fear may be realized in some instances, principally with respect to unused registrations held for speculative purposes, product losses from the reregistration fees alone will not be widespread. Some such attrition will occur. Small volume pesticides will be particularly vulnerable,¹⁰³ although the amendments provide exceptions for certain minor use products and other small volume pesticides.¹⁰⁴ How EPA exercises its discretion in defining "small volume" products will be important, although not vital, to a product's survival. More influential will be the cost, uncertainty, and problems revealed by the testing required, and the pesticides sellers' ability to pass added costs to customers through price increases or other means.

Some observers speculate that pesticide users may choose to assume directly the costs of testing to preserve pesticides that would otherwise be abandoned. This thought is reflected in the amendments' provision that allows users and others an opportunity to assume responsibility for products whose registrants elect not to seek reregistration.¹⁰⁵ In the past, user interest in registering and reregistering products has not often been expressed, but this could change if products vital to users are threatened.¹⁰⁶

Some observers also anticipate that the financial pressure and uncertainty of reregistration on older products will encourage the development and marketing of new products. With the ever-increasing number and sophistication of testing requirements for registration, new products have been generally less able to compete economically with the older products already on the market. Although subjecting older products to current testing requirements sooner will place new products on an equal footing quicker, this change is unlikely to have a major effect on new product introduction. The loss of products already at the end of their market life or failing to attract further investment in testing costs is unlikely to open the kind of significant new markets to be an incentive to new product development.

The amendments will also affect the composition of the industry, particularly impacting those who produce and market older products. Over the last several years, a segment of the pesticide industry based on generic products has matured. These products, competing with "brand name" pesticides, are generally older and may be produced by anyone who is willing to conduct the tests for registration or to pay compensation for the right to rely on existing data. For older products that have not been required to meet current testing and registration requirements, there will be increased costs that will challenge their producers' commitment to further marketing. If there are fewer survivors among these older products, as is to be expected, there will be increased competition among the producers of the remaining viable generic alternatives.¹⁰⁷

Changes to FIFRA's provisions on indemnification, recall, storage, and disposal will also disproportionately affect producers of older products. Older products are more likely to pose health or environmental problems that will be revealed by the modern testing requirements to which they have not previously been subjected. They are [19 ELR 10082] prime targets for suspension and cancellation. Producers who choose to continue to market such products will face significant potential costs if the product has to be recalled and purchasers indemnified.

The amendments will also affect the relationship between buyers and sellers of products subject to cancellation or suspension. The amendments require all in the chain of distribution to reimburse their formulator, wholesaler, and retailer customers for products that are suspended or cancelled after the sale occurs, unless the supplier provides notice at the time of the sale that there will be no reimbursements. Assurance of reimbursement will be a marketing necessity for many products, even those facing no realistic threat of adverse government action. Companies that can credibly assure their customers of reimbursement will be advantaged. This ability will put a premium on a company's independent financial strength or on assurances from financially secure suppliers. The alternatives are to market only "safe" products, where assurances of reimbursement are unnecessary, or to attempt to sell products under a potential regulatory cloud to skittish customers. Neither option may be realistic for some companies.

Conclusion

The 1988 Amendments are important in addressing the problem of older pesticides and in their effects on the regulated industry and the public. The result of expedited reregistration and related provisions will be a greater assurance that pesticides do not present unacceptable risks and still provide the benefits that justify their use. While there will remain sharp differences about whether certain products cause unreasonable adverse effects on the environment, the amendments should improve the nature of the debate, so that it is based more on scientific fact and less on emotion.

1. 7 U.S.C. §§ 136-136y (1988), amended by Pub. L. No. 100-532, __ Stat. __ (1988), ELR STAT. FIFRA 001-034. A "pesticide" is a substance or mixture that is intended to prevent, destroy, repel, or otherwise control "pests," or is a plant dessicant or growth regulator. FIFRA § 2(u), 7 U.S.C. § 136(u), ELR STAT. FIFRA 004. Pests include undesired insects, weeds, and microorganisms. FIFRA § 2(t), 7 U.S.C. § 136(t), ELR STAT. FIFRA 004. There are about 40,000 registered pesticide products in use, each containing one or more of some 600 active ingredients. Of the approximately 1 billion pounds of pesticides annually sold in the United States, approximately 80 percent are used in agriculture, 15 percent in industry and government, and 5 percent in homes. GENERAL ACCOUNTING OFFICE, PESTICIDES — EPA's FORMIDABLE TASK TO ASSESS AND REGULATE THEIR RISKS, at 10, RCED 86-125 (1986) (hereinafter "GAO REPORT"). EPA assumed responsibility for administering FIFRA in 1970 when President Nixon transferred responsibility from the Department of Agriculture (USDA) to EPA in Reorganization Plan No. 3 of 1970, reprinted in 5 U.S.C. App. at 1132 (1982), and in 84 Stat. 2086 (1970).

2. A registration is a license issued by EPA that allows the sale and distribution in commerce of a particular pesticide product. A registration is issued in response to an application that describes the product's proposed composition, packaging, and labeling. A registrant may also request EPA approval of an amendment to an existing registration, e.g., to change the labeling to permit the product's use on additional crops or allow different methods of use. "Reregistration" has come to mean a systematic, EPA-initiated reevaluation of previous registration decisions on pesticide products having an active ingredient, including an examination of the data base now thought necessary to support the product's uses, a requirement for submission of any missing data, and a reevaluation of the old and new data. See also infra note 22.

3. Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988, Pub. L. No. 100-532, __ Stat. __ (1988). While federal pesticide regulation dates from the early 1900s with enactment of the Insecticide Act of 1910 (36 Stat. 331), significant government control over pesticides did not begin until 1947 with the passage of the Federal Insecticide, Fungicide, and Rodenticide Act. Pub. L. No. 80-104, 61 Stat. 163 (1947). The law has been amended several times since then: Pub. L. No. 88-305, 78 Stat. 190 (1964); Pub. L. No. 92-516, 86 Stat. 973 (1972); Pub. L. No. 94-140, 89 Stat. 751 (1975); Pub. L. No. 95-396, 92 Stat. 819 (1978); Pub. L. No. 96-539, 94 Stat. 3194 (1980).

4. SENATE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY, REPORT ON THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE REFORM ACT OF 1988, Rep. No. 346, 100th Cong., 2d Sess. (1988) (hereinafter "SENATE REPORT").

5. See, e.g., 134 CONG. REC. S13456 (daily ed. Sept. 28, 1988) (remarks of Senator Lugar).

6. Pesticide Safety Legislation Sent to President, Wash. Post, Sept. 29, 1988, at A14.

7. See, e.g., SENATE REPORT, supra note 4, at 7. In a 1976 study of EPA's reregistration efforts, a Senate staff report asserted that "the importance of EPA's determining whether the previously registered 50,000 pesticide products should be reregistered for continued use cannot be overemphasized." STAFF OF SENATE SUBCOMMITTEE ON ADMINISTRATIVE PRACTICE AND PROCEDURE, 94TH CONG., 2D SESS., REPORT ON THE ENVIRONMENTAL PROTECTION AGENCY AND THE REGULATION OF PESTICIDES (1976)(hereinafter "KENNEDY REPORT") 5.

8. This viewpoint has become more prevalent since 1962, when Rachel Carson's Silent Spring warned of the "contamination of air, earth, rivers, and sea with dangerous and even lethal materials," namely chemical pesticides. R. CARSON, SILENT SPRING 6 (1962). While recognized as not a scientific treatise, the book mobilized public interest in increased pesticide regulation that continues to the present. See, e.g., Hearings on H.R. 2463 Before the Subcommittee on Department Operations, Research, and Foreign Agriculture of the House Committee on Agriculture, Serial No. 100-13, 100th Cong., 1st Sess. 660 (Apr. 7, June 10, 16, and 17, 1987) (statement by Ralph Nader that public opposition to pesticides is growing).

9. Press Release on Introducing the FIFRA Reform Act of 1987, Senator Leahy, July 21, 1987.

10. See, e.g., Hearings on H.R. 4364 Before the Subcommittee on Department Operations, Research, and Foreign Agriculture of the House Committee on Agriculture, Serial No. 99-7, Pt. 2, 99th Cong., 2nd Sess. (Mar. 19-20, 1986), at 7-23 and 93-97.

11. FIFRA §§ 3(a), 12(a)(1)(A), 7 U.S.C. §§ 136a(a), 136j(a)(1)(A), ELR STAT. FIFRA 005,022.

12. The 1947 FIFRA amendments introduced the concept of product registration. Until 1964, however, registration did not necessarily signify government approval. See infra note 22.

13. Registration data requirements for a pesticide may include hundreds of individual studies on health and environmental effects. These studies are prescribed in detail by regulation, with specified test protocols and laboratory practices. 40 C.F.R. §§ 158 and 160. Such regulations require tests to determine acute toxic effects through oral, dermal, and inhalation exposure, possible chronic toxic effects such as cancer, birth defects, and reproductive harm, and the efficacy of the product. Detailed studies must also be made of the possibility of residues remaining on the crop or in the animal, of effects on soil microfauna and microflora, and of possible dangers, either directly or indirectly, to fish, birds, and other wildlife.

14. Pesticide active ingredients are rarely sold to users in their pure form. They are usually sold in formulations that facilitate their effectiveness and safety. Formulations contain the active ingredient and various other chemicals (such as solvents, colors, and preservatives) called "inert" ingredients. Some so-called inert ingredients have significant toxic effects themselves, while others are innocuous (such as salt, sugar, and water).

15. FIFRA § 3(c)(5), 7 U.S.C. § 136a(c)(5), ELR STAT. FIFRA 007.

16. For a discussion of this evolution of testing requirements, see HOUSE SUBCOMMITTEE ON DEPARTMENT OPERATIONS, RESEARCH, AND FOREIGN AGRICULTURE, REGULATORY PROCEDURES AND PUBLIC HEALTH ISSUES IN THE EPA'S OFFICE OF PESTICIDE PROGRAMS, H. DOC. NO. NNNN, 97th Cong., 2d Sess. 105-109 (1982). See also GENERAL ACCOUNTING OFFICE, FEDERAL PESTICIDE REGISTRATION PROGRAM: IS IT PROTECTING THE PUBLIC AND THE ENVIRONMENT ADEQUATELY FROM PESTICIDE HAZARDS?, RED 76-42 (1975).

17. In 1978, Congress provided EPA withexplicit authority under FIFRA § 3(c)(2)(B) to require the generation and submission of additional data needed to support the ongoing registration of a pesticide, and provided a very persuasive sanction — suspension of the pesticide's registration — in cases where the registrant failed to take appropriate steps to ensure the timely submission of requested data. Before 1978, EPA's authority to require the submission of data on old pesticides was not clear.

One long-standing provision of FIFRA perhaps could have been used to update the data on file in support of registrations, but never has been. FIFRA § 6(a)(1) states:

The Administrator shall cancel the registration of any pesticide at the end of the five-year period which begins on the date of its registration (or at the end of any five-year period thereafter) unless the registrant, or other interested person, requests in accordance with regulations prescribed by the Administrator that the registration be continued in effect: Provided, That the Administrator may permit the continued sale and use of existing stocks of a pesticide whose registration is canceled under this subsection or subsection (b) to such extent, under such conditions, and for such uses as he may specify if he determines that such sale or use is not inconsistent with the purposes of this Act and will not have unreasonable adverse effects on the environment. The Administrators shall publish in the Federal Register, at least 30 days prior to the expiration of such five-year period, notice that the registration will be canceled if the registrant or other interested person with the concurrence of the registrant does not request that the registration be continued in effect.

7 U.S.C. § 136d(a), ELR STAT. FIFRA 016.

This provision originated in the 1947 FIFRA. Implementing regulations in effect from 1964 through 1976 stated simply that, upon a request for continuation of a registration,

it shall be continued in effect under the same terms as the original registration; Provided, however, That if, on the basis of information available at the time, it appears that the product or its labeling fails to comply with the Act, the registrant shall be so notified …. If the [needed] corrections are not made, registration will be cancelled as provided for in section 4(c) of the [1964] Act.

See 7 C.F.R. § 362.10 (1964); 40 C.F.R. § 162.10(j)(1975). Regulations issued in July 1975 that became effective in 1976 (see, e.g., 40 C.F.R. § 162.6(c) (1978)) purported to change the significance of the "continuation" provision. Those regulations required EPA to issue a notice of intent to cancel five years a product's registration. The notice was to cite FIFRA § 6(a)(1) as its authority. The regulations said that the product could be canceled unless continuation was requested, and went on to spell out a requirement for updating the data base:

The Administrator shall continue in effect a registration only upon determination that the registration complies with all requirements of the Act and the current regulations promulgated thereunder, including all data requirements as specified in the Registration Guidelines for new registrations.

However, events overtook this regulatory approach. In September 1975, EPA issued further regulations concerning reregistration (40 C.F.R. § 162.43(f)(3)) that stated:

For the duration of the period of reregistration, the five-year renewal requirement has been suspended. No product registration will lapse prior to October 21, 1976, because of the expiration of the five-year period.

The stretch-out of reregistration (see infra text accompanying note 42) and the 1978 addition of authority to require data submissions under FIFRA § 3(c)(2)(B) may have rendered § 6(a)(1) obsolete as a device for updating a pesticide's data base. Indeed, EPA's recently issued regulations replacing 40 C.F.R. § 162 (40 C.F.R. § 152, 53 Fed. Reg. 15952, May 4, 1988) contain no mention of the five-year renewal provision. Moreover, questions remain about whether EPA really has authority to cancel a registration without an administrative hearing on the basis of an informal, unilateral EPA decision that a renewal request is not supported by all required data. Finally, a periodic renewal process is likely to be a clumsy way to deal with similar products that happen to have different anniversary dates. FIFRA § 6(a)(1) has not been used at all since 1976. However, the possibility exists that EPA may attempt to bring it out of mothballs as a means of concluding the reregistration process itself, e.g., by refusing to "continue" the registration of a product that has been found not eligible for "reregistration."

18. Under FIFRA § 6 (and somewhat similar provisions of § 4(c) of the pre-1972 FIFRA), EPA may cancel the registration of a pesticide found to pose unreasonable adverse effects on the environment (i.e., its risks exceed its benefits). The major effect of cancellation is to make illegal the further sale or distribution of the pesticide except to the extent allowed by EPA. A registrant who receives a notice of EPA's intent to cancel a registration has the right to demand an adjudicatory hearing before the Agency prior to issuance of a cancellation order, and to obtain judicial review of an unfavorable hearing decision. FIFRA §§ 6(b), 6(d), 16(b), 7 U.S.C. §§ 136d(b), 136d(d), 136n(b), ELR STAT. FIFRA 016, 017, 026. See also infra note 78.

19. Some updating and reevaluation does occur as a result of requests for amendments to registrations. The registrant of a pesticide may apply for an amendment to the registration to add new uses or otherwise change the labeling. Applications for such amendments often are supported by new data that must be evaluated. Since the filing of amendments is within the control of the registrant, however, this updating is not systematic. Moreover, applicants seeking amendments usually have been required to submit only that new data needed to justify approval of the amendment. They usually have not been required to rejustify, under the newer data requirements in effect at the time of the request for amendment, the uses previously approved. This again is a function of the statute's basic structure — government reaction to an applicant's request.

20. FIFRA §§ 3(d) and 4, 7 U.S.C. §§ 136a(d), 136b (1982). (Note that the 1988 amendments moved the contents of old § 4 to § 11.)

21. Section 4(c)(2) of the Federal Environmental Pesticide Control Act of 1972 (FEPCA), Pub. L. No. 92-516, October 21, 1972. FEPCA contained the 1972 FIFRA amendments as well as separate effective-date and implementation schedule provisions.

22. FIFRA § 2(z), 7 U.S.C. § 136(z), ELR STAT. FIFRA 004. The term "reregistration" was not introduced in the 1972 FIFRA amendments. From 1947 until 1972, FIFRA § 3(a)(1) said that it was unlawful for any person to sell any pesticide

if any of the claims made for it or any of the directions for its use differ in substance from the representations made in connection with its registration, or if [its] composition … differs from its composition as represented in connection with its registration; Provided, that in the discretion of the Secretary, a change in the labeling or formula of [the pesticide] may be made within a registration period without requiring reregistration of the product.

FIFRA § 3(a)(1), 7 U.S.C. § 135a(a)(1) (1970) (emphasis added). Under FIFRA from 1947 until the 1964 amendments, a pesticide legally could be sold without prior USDA approval. If USDA, after review of an application for registration, found that the pesticide did not comply with FIFRA's requirements, the applicant could insist that USDA register the pesticide "under protest." In fact, only a few products were issued "protest" registrations; most were approved by USDA before being registered. But in any event, a pesticide could not be legally marketed unless it had some type of registration, ensuring that USDA would be aware of the labeling, packaging, and composition of the product being marketed. USDA could bring a court action to seize a pesticide that was "misbranded," even if it had been registered under protest. The quoted language thus meant that a product generally could not legally be sold in a form significantly different from that previously described to USDA without first being "reregistered" as a new product. In 1964, the law was amended to require USDA approval before a registration was issued, thus eliminating "protest" registrations, but the provision in which "reregistration" appeared was not changed.

It is thus not particularly surprising that Congress in 1972 did not spell out how EPA was to conduct "reregistration," nor that the only mention of "reregistration" in the 1972 FIFRA was the sentence in the definitions section stating that "[t]he term 'registration' includes 'reregistration'." Reregistration was simply the time-honored name for the result sought by a registrant who requested EPA approval of a significant change inthe composition or labeling of an already registered product.

The 1972 amendments did, of course, contemplate that EPA would receive and have to process thousands of requests for such "reregistrations" in a short time, as a result of the major new classification program and a new, corollary provision stating that a registered product would be "misbranded" and, thus not legally marketable, if its label did not state the product's classification.

23. See FIFRA § 3(c)(2)(A), 7 U.S.C. § 136a(c)(2)(A), ELR STAT. FIFRA 006 (data requirements); FIFRA § 3(c)(5), 7 U.S.C. § 136a(c)(5), ELR STAT. FIFRA 007 (evaluation and approval of applications for registration). An early draft of the bill would have included the term "registration or reregistration" in those two sections. House Agriculture Committee, "Committee Print No. 2," June 16, 1971.

24. In his introduction to a 1976 Senate staff report on the problems of reregistration, Senator Kennedy remarked:

I fully appreciate the constraints under which EPA was operating in attempting to perform the pesticide reregistration task. The agency was faced with a Congressional deadline of October 1976 (later extended to October 1977) to complete it. Determining whether to reregister 50,000 pesticide products currently on the market is an enormous undertaking. EPA was unable to obtain sufficient resources with which to accomplish the task. These factors have played a part in making pesticide regulation a failure.

KENNEDY REPORT, supra note 7, at 1.

25. These early problems are described in GAO REPORT, supra note 16.

26. An EPA witness told Congress in 1977:

The original strategy for reregistration was to screen and separate pesticides into two categories: one, those suspected of posing an unreasonable risk to man or the environment; and two, those for which no evidence of potential unreasonable adverse effects was known.

Pesticides falling into the first category were to be subjected to an intensive review with a full data validation — scientific review and confirmation of results by EPA technical staff. Those in the second category were to be classified, their labeling updated, and examined for data gaps — tests required by today's standards which were not performed in the past.

The data supporting registrations of products in that [second] category were not to be individually evaluated and validated ….

Hearings Before the House Committee on Agriculture, Serial No. 95-H, 95th Cong., 1st Sess. 201-202 (Mar. 7, 1978) (statement of Andrew Briedenbach).

27. 40 C.F.R. § 162.6(b)(5)(ii) (1976); 40 Fed. Reg. 28242, 28250, 28274 (July 3, 1975); 41 Fed. Reg. 7218, 7219 (Feb. 17, 1976).

28. Compare 40 C.F.R. § 162.8(c) (1976) (data required for reregistration) with 40 C.F.R. § 162.8(b) (data required for new registration). In issuing these regulations, EPA said:

[F]ull compliance with the data requirements imposed on new registrations would be desirable for reregistration as well. By October 1976, however, EPA must reregister in excess of 30,000 pesticide products. It would be administratively impossible to require all of these products to satisfy the data requirements for new registration.

40 Fed. Reg. 28242, 28250 (July 3, 1975).

EPA planned to use the five-year renewal requirement of FIFRA § 6(a)(1) to obtain the remaining data (see supra note 17).

29. KENNEDY REPORT, supra note 7, at 1, 14-15.

30. 40 Fed. Reg. 28242 (July 3, 1975); 40 Fed. Reg. 26801 (June 25, 1975).

31. KENNEDY REPORT, supra note 7, at 16; Hearings Before the Subcommittee on Departmental Investigations, Oversight, and Research, House Committee on Agriculture, 95th Cong., 1st Sess., at 163 (Apr. 27, 1977) (EPA witness states that EPA "is making every effort to catalog data").

32. Supra note 17.

33. Other important questions, such as whether an application for reregistration was required and had to be approved or denied, and whether the existing registration expired immediately if the reregistration application was so denied, were not addressed by the law (and still have not been). An additional problem was that the statute seemed to require an applicant for a new registration to submit or cite a complete set of data in support of his application, while registrants of identical or closely similar products already on the market would be allowed to continue marketing while filling in the data gaps, thus creating a double standard.

34. The issues of data compensation and trade secrecy have plagued pesticide regulation in recent years and undoubtedly will be a future problem as well. These issues were not significant prior to 1972 because of the structure of the industry and the relatively small economic stake of companies in data necessary for registration. The 1972 law's inadequacy in addressing the issues was partially remedied in 1975 and in 1978. The "data compensation" issue arises under FIFRA § 3(c)(1)(D). To avoid unnecessary and duplicative testing and to foster competition among pesticide producers, Congress permitted "follow-on" or "me-too" registrants to obtain a registration by citing data previously submitted by another registrant. In doing so, a follow-on registrant must offer to pay compensation. Disputes over compensation are resolved by binding arbitration. FIFRA does not define what compensation is "appropriate," leaving the definition to private negotiations between the registrants or to arbitrators. Because of evident uncertainties and potentially prohibitive costs of compensation presented in this provision, certain follow-on registrants from time to time have pressed for amendments to clarify their liabilities. The issue has been sharply contested and, although a partial compromise was adopted in the failed 1986 amendments, no resolution was contained in the 1988 amendments.

35. Ruckelshaus v. Monsanto, 467 U.S. 986, 14 ELR 20539 (1984) (EPA's use of post-1978 data does not constitute an unconstitutional taking); Thomas v. Union Carbide Agricultural Products Co., 473 U.S. 568, 15 ELR 20698 (1985) (FIFRA's arbitration requirement is not an unconstitutional delegation to the executive branch of the judicial power). See also National Agricultural Chemicals Association v. United States Environmental Protection Agency, 554 F. Supp. 1209, 13 ELR 20560 (D.D.C. 1983)(EPA's "cite all" regulations exceed FIFRA authority); Safire and Reagan, Data Use and Compensation Under FIFRA: Can Monsanto Survive Supreme Court Review? 14 ELR 10055 (1984).

36. The basic regulations setting out EPA's approach to reregistration appeared as 40 C.F.R. § 162.6(b)(5) (requirements and procedures), § 162.8(c) (data requirements), § 162.11(a) and (b) (criteria, based on toxicity and exposure, raising presumption against registration or reregistration), and § 162.11(c)(criteria for classification), in 40 Fed. Reg. 28242, 28274, 28277, 28281-84 (July 3, 1975). Additional regulations concerning application procedures and Agency processing of applications appeared as 40 C.F.R. §§ 162.41-162.47 in 40 Fed. Reg. 42788 (Sept. 9, 1975). EPA also published a notice (41 Fed. Reg. 7218, Feb. 17, 1976) dealing with data requirements for reregistration. This notice explained that each active ingredient had been assigned to one of five groups on the basis of (1) EPA's determinations regarding the presence or absence of various required studies in its files and (2) whether the data indicated that a presumption existed against continued reregistration of products containing the ingredient. The notice also specified a schedule for submission of applications for reregistration.

37. Testimony by EPA Assistant Administrator Andrew Breidenbach, supra note 26.

38. Supra note 27.

39. In spring 1976, the U.S. Food and Drug Administration audited the Industrial Bio-test Laboratory (IBT), then a major toxicological testing laboratory, and found serious inadequacies and fraud in some experiments. Many of these studies had been central to the support of applications for pesticide registrations. See Hearings on EPA's Pesticide Registration Activities Before the House Committee on Government Operations, 98th Cong., 1st Sess. (Sept. 12, 1983). See also HOUSE SUBCOMM. REPORT, Supra note 16, at 201-202.

40. See KENNEDY REPORT, supra note 7, at 27-29.

41. ENVIRONMENTAL PROTECTION AGENCY, FIFRA: IMPACT ON THE INDUSTRY, SENATE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY, REPORT ON EXTENSION OF THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT, REP. NO. 334, 95th Cong., 1st Sess. 34-55 (1977).

42. FIFRA § 3(g) (repealed by 1988 amendments). See SENATE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY, REPORT ON THE FEDERAL PESTICIDE ACT OF 1978, 95th Cong., 2nd Sess. 45 and 147 (Jan. 1979). see also SENATE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY, REPORT ON THE EXTENSION OF THE FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT, Rep. No. 334, 95th Cong., 1st Sess. 3 (1977).

43. FIFRA § 3(c)(2)(B), 7 U.S.C. § 136a(c)(2)(B), ELR STAT. FIFRA 006.

44. FIFRA § 3(c)(7), 7 U.S.C. § 136a(c)(7), ELR STAT. FIFRA 008. See supra note 33.

45. FIFRA §§ 3(c)(1)(D) (exclusive use and mandatory licensing) and 10 (public disclosure of health and environmental data and disclosure to foreign or multinational producers), 7 U.S.C. §§ 136a(c)(1)(D), 136h, ELR STAT. FIFRA 005.

46. FIFRA § 3(c)(2)(D), 7 U.S.C. § 136a(c)(2)(D), ELR STAT. FIFRA 007.

47. 44 Fed. Reg. 76311 (Dec. 26, 1979).

48. Essentially, a "registration standard" sets out the conditions that products containing an active ingredient must meet if they are to be reregistered. The process of standard generation consists of a determination of the validity of existing data, identification of data gaps, a "request" (i.e., a demand) for necessary data, data generation and submission, and review. The process concludes with publication of a final regulatory standard and, as needed, tolerance reassessment. 40 C.F.R. § 155 (1987). For registration standards currently under development, see 53 Fed. Reg. 47865-47867 (Nov. 28, 1988).

49. HOUSE COMMITTEE ON AGRICULTURE, REPORT ON THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT AMENDMENTS OF 1988, Rep. No. 939 (Part 1), 100th Cong., 2nd Sess. (1988) (hereinafter "HOUSE REPORT") 28.

50. GAO REPORT, supra note 1.

51. In 1980, the EPA's pesticide program had about 830 employees and $ 45 million expenditures. In 1985, the program had about 600 employees and $ 44 million expenditures. Id. at 45. See also HOUSE SUBCOMM. REP., supra note 16, at 270-272.

52. National Academy of Sciences, Toxicity Testing: Strategies to Determine Needs and Priorities (1984).

53. GAO REPORT, supra note 1, at 20-57; GENERAL ACCOUNTING OFFICE, DELAYS AND UNRESOLVED ISSUES PLAGUE NEW PESTICIDE PROTECTION PROGRAMS, at 4-27, CED-80-32 (1980).

54. A suspect carcinogen, EDB, was found in much of the nation's food. Hearings on Government Regulation of the Pesticide Ethylene Dibromide (EDB), Before the House Committee on Government Operations, Subcommittees on Environment, Energy, and Natural Resources and Intergovernmental Relations and Human Resources, 98th Cong., 2d Sess. (Mar. 5-6, 1984). Heptachlor was discovered in milk in Arkansas, and aldicarb in watermelons in California and drinking water in Long Island. Robbins, Tainted Feed Brings Milk Recalls: Is a Costly Nightmare to Farmers, New York Times, Mar. 16, 1986, at A1. Diamond, Union Carbide Pesticide Drawing New Scrutiny, New York Times, July 10, 1985, at D1.

55. Natural Resources Defense Council, Inc. v. Environmental Protection Agency, No. 83-1509 (D.D.C., Oct. 10, 1984) (order approving a settlement agreement on alleged preferential access to EPA decisionmakers and the decisionmaking process).

56. In 1982, the House Agriculture Committee, at the urging of the pesticide industry, reported a bill to address a number of "business" issues. Major amendments were to increase the period of "exclusive use" of new pesticide data from 10 to 15 years, preempt state efforts to regulate pesticides, and restrict public access to proprietary test data. With active environmental lobbying, the House rewrote the bill on the floor, significantly modifying several provisions and adding both a private right of action and a ban on toxaphene. The bill was never considered in the Senate.

57. NACA has sought patent term restoration (PTR) legislation since 1980, almost succeeding in 1982 and 1984. The pharmaceutical industry was able to obtain passage of a similar bill in 1984, the Pharmaceutical Patent Term Restoration Act, Pub. L. No. 98-417. A PTR bill would amend the patent law to restore the portion of the 17-year patent term that pesticides lose as a result of federal testing and review requirements. Research-based companies represented by NACA see PTR as a way to encourage needed research that may yield useful new products. For a discussion of the role of PTR in the NACA-CPR negotiations, see Control Pests and Monopoly, Too, New York Times, Mar. 13, 1986, at A26.

58. Stanfield, Politics Pushes Pesticide Manufacturers and Environmentalists Closer Together, National Journal, Dec. 14, 1985, at 2846.

59. NACA represents 80 ofthe largest U.S. manufacturers and distributors of agricultural pesticides.

60. The Coalition for Pesticide Reform (CPR) was a diverse group, including the Natural Resources Defense Council, AFL-CIO, Public Citizen's Congress Watch, Sierra Club, and Consumer Federation of America. However, CPR did not represent all of the environmental interests pressing for FIFRA reform. The National Audubon Society, Defenders of Wildlife, and Environmental Defense Fund never joined CPR, although their informal support for CPR's efforts varied depending on CPR's perceived success on various issues.

61. The centerpiece of the legislation was a detailed schedule for reregistration and a directive for fees to support reregistration's cost. Other important provisions were changes to EPA's procedures for canceling registrations, clarification of EPA's groundwater protection authority for pesticides, regulation of inert ingredients in pesticide formulations, provision for public access to data supporting registration applications, limitations on state authority to set residue tolerances for pesticides in food, and limitations on farmer liability for lawful pesticide use.

62. The House passed H.R. 2482 on September 19, 1986. 132 CONG. REC. H7240, H7243, H7248 (daily ed. Sept. 19, 1986). The Senate passed a similar bill (S.2792) on October 6. 132 CONG. REC. S15286, S15355 (daily ed. Oct. 6, 1986). The House again passed H.R. 2482 with some of the Senate's amendments on October 16. The Senate never reconsidered the bill.

63. The unresolved issues were: (1) state authority on pesticide residues in food, (2) groundwater, (3) farmer liability for lawful pesticide use, (4) data compensation, and (5) patent term restoration. No single issue was fatal and all could have been compromised if more time had been available. For a discussion of the failure of the 1986 amendments, see Freistadt, Time for Cooperation, AGRICHEMICAL AGE, Jan. 1988, at 22; Davis, Pesticide Law Overhaul: Back to Square One, CONG. Q., Feb. 21, 1987, at 321.

64. For a discussion of these negotiations, see Stanfield, supra note 58, at 2846; J. BOSSO, PESTICIDES AND POLITICS 207 (1987).

65. Davis, supra note 63, at 322.

66. Both amendments were highly controversial. The uniform tolerances amendment would have clarified federal and state authority to set pesticide residues on food, with a presumption that federal tolerances for reregistered pesticides would preempt state tolerances. The farmer liability amendment would have exempted agricultural producers from liability imposed under federal statutes for damages caused from pesticides applied in accordance with FIFRA label directions.

67. 134 CONG. REC. S13454 (daily ed. Sept. 28, 1988).

68. The active ingredient fee is expected to raise a total of $ 20 million to $ 45 million over six years. The maintenance fee is expected to raise $ 14 million annually over nine years. HOUSE REPORT, supra note 49, at 77. Critical to lack of opposition by the pesticide industry was the fee's 1997 sunset provision that coincides with the projected end of the reregistration program, and the prohibition on any other fees for pesticide registration during the period. See HOUSE REPORT, supra note 49, at 45. This latter prohibition mooted EPA's recently issued registration fee regulations, 53 Fed. Reg. 19108-19115 (May 26, 1988).

69. New FIFRA § 4(i)(1)-(4), ELR STAT. FIFRA 013. A detailed breakdown of the active ingredient fees is as follows:

Active Ingredients With Major Food Uses

* $ 50,000 at Phase Two.

* $ 100,000 at Phase Three.

* $ 150,000 at EPA discretion for those pesticides for which a registration standard has been issued.

Active Ingredients Without Major Food Uses

* $ 25,000-$ 50,000 at Phase Two.

* $ 50,000-$ 100,000 at Phase Three.

* $ 50,000-$ 100,000 at EPA discretion for those pesticides for which a registration standard has been issued.

Active Ingredients Solely With Minor Uses/Small Businesses/Small Uses

* No fees for pesticides registered solely for minor uses.

* Small business (150 or fewer employees and gross chemical sales of $ 40 million or less):

* less than $ 5 million — 0.5% of revenues from the sale of pesticides containing the active ingredient.

* $ 5 million-$ 10 million — 1.0% of revenues.

* more than $ 10 million — 1.5% of revenues up to $ 150,000 cap.

* No fees for certain antimicrobial active ingredients under 1 million pounds annual production.

* No fees for formulators.

If two or more active ingredient registrants must pay the fee, it is apportioned by U.S. market share. New FIFRA § 4(i)(7), ELR STAT. FIFRA 015. Registrants with no market share pay the lesser of 15 percent of the fee or lowest share percentage with a cap of 25 percent. In discussions on the 1988 amendments, the generic pesticide producers prevailed against earlier proposals to split the registration fee evenly among all producers. Presumably, an equal allocation would favor large manufacturers. (Congress was careful to state that this market share allocation for fees was to have no implications for the data compensation provisions of FIFRA. See HOUSE REPORT, supra note 49, at 45; supra, note 34.) This allocation by market share, however, may delay EPA in collecting the fee, because to do so the Agency will need sales information from registrants and OMB approval for the data request.

70. New FIFRA § 4(i)(5), ELR STAT. FIFRA 014. While subject to adjustment to raise $ 14 million per year, the fee set in the statute for a registrant's first 50 registrations nominally is $ 425 per registration, with a cap of $ 20,000. The fee for registrants holding more than 50 but less than 200 registrations is $ 100 per registration over 50, with a total cap of $ 35,000. No fee is levied on registrations over 200. There is no exemption for formulators. Most registrants have 10 or fewer product registrations. See SENATE REPORT, supra note 4, at 109. It is important to note that EPA may cancel the registration by order and without hearing if a fee is not paid on time. New FIFRA § 4(i)(5)(D), ELR STAT. FIFRA 014.

71. Active ingredients not present in any product registered before November 1, 1984, are exempt from reregistration. New FIFRA § 4(a), ELR STAT. FIFRA 010. Also exempt are products that EPA finds have no outstanding data requirements and otherwise meet FIFRA § 3(c)(5) registration requirements (this category is likely to be small).

72. The phased application of requirements and schedules to groups of active ingredients will result in a process that resembles a staggered-start race. One block of 150 active ingredients is to begin the process four months after the effective date of the amendments, to be followed three months later by a second block, followed by a third block three months after the second. The plan is for each block to go through the reregistration process in about eight to ten years, although it could easily take longer. Like a staggered-start race, once it begins it may be difficult for observers and participants alike to tell how registrants of various products are performing.

73. New FIFRA § 4(c), ELR STAT. FIFRA 010. EPA must list all active ingredients for which registration standards have been issued and then split the other active ingredients into three groups according to their priority for reregistration. The statutory requirements for EPA's priority setting are common sense ones. EPA is instructed to give priority to those active ingredients that, among other things, may leave residues in food or feed, may cause significant groundwater and seafood contamination, have been identified as already containing significant data deficiencies, or are used in areas where worker exposure is most likely to occur.

The registration standards list must be completed by March 4, 1989 (70 days after the law's effective date of December 24, 1988). The first block of 150 priority pesticide active ingredients must be identified by April 24, 1989 (four months after the effective date), and the second block of 150 pesticide active ingredients filled by July 24, 1989 (seven months after the effective date). The third and final block of the remainder of pesticide active ingredients for reregistration must be filled by October 24, 1989 (ten months after the effective date). The priority listing in each block is to be published in the Federal Register and is not subject to judicial review.

74. New FIFRA § 4(d), ELR STAT. FIFRA 010. Participating registrants must supply, in addition to the first part of their reregistration fee in Phase Two (due about the end of 1989), and identification of (i) data that are required to support each registration, (ii) data submitted that were "inadequate" to meet such requirements, and (iii) data that were not submitted. Inadequate data are studies for which a registrant cannot certify that it possesses or has access to the raw data, and studies conducted before January 1, 1970 (unless the registrant demonstrates to EPA's satisfaction that they support the registration). It is unclear at this point whether this initial "screen" for data that should be developed and submitted to EPA means more than simply data that are missing or developed prior to 1970.

Registrants must make their responses within three months after EPA's notice, although the Administrator may extend the time indefinitely for good cause. Registrants have a reasonable period of time, but not more than four years after this commitment, to conduct the missing and inadequate studies. The Administrator may extend this testing two years for good cause. EPA may suspend a registration if insufficient progress is made to meet the test deadlines. See infra note 78 on "suspension."

With respect to registrants who do not reply to EPA's notice, EPA must publish an intent to cancel the applicable registrations and allow 60 days for comment. See infra note 78 on "cancellation." The Administrator then may cancel the registrations without a hearing or take such other action necessary to enable reregistration of the pesticides by another person. If all registrants of products containing a particular active ingredient fail to reply or decline reregistration, the Administrator must publish a notice of intent to cancel the registrations and provide a 60-day opportunity for comment, and then may cancel all such registrations without a hearing, unless certain prescribed actions are taken by others to acquire the rights of the registrants and meet the requirements of Phase Two.

75. New FIFRA § 4(e), ELR STAT. FIFRA 011. If the registrant fails to submit the information required, the Administrator must cancel the registration by order and without hearing. Notably, EPA is not authorized by FIFRA to extend the nine-month deadline for completion and submission of this information. The Administrator may, however, allow additional time if the registrant submitted inadequate information in good faith. Disputes over whether a registrant acted in good faith are decided by a formal hearing. Registrants who make the second commitment to submit data must conduct the studies and submit the data within a reasonable time determined by the Administrator, but not more than four years. Again, the Administrator may extend this time by no more than two years for extraordinary circumstances. The Administrator is charged to monitor the progress of registrants in acquiring and submitting the data required and may take action to suspend the registration if insufficient progress is made.

76. New FIFRA § 4(f), ELR STAT. FIFRA 013. The amendments permit the Agency a different time period to complete this independent review for each block of priority active ingredients: 6 months for the first 150 active ingredients, 12 months for the second, and 21 months for the third. Again, registrants must submit the required data within a reasonable period of time as determined by the Administrator, but not more than four years, with a two-year extension if extraordinary circumstances warrant. The Administrator also has authority to suspend the registration of products for which tests are not initiated within one year after EPA's data call-in notice or if progress is insufficient to ensure submission of the data within the time required by the Agency.

77. New FIFRA § 4(g), ELR STAT. FIFRA 013. EPA must conduct the examination of the data submitted to support the active ingredients within twelve months, and may extend the period for an additional one year for extraordinary circumstances. If additional product-specific data are needed, as they may be on individual formulations, the Administrator may permit eight months for the generation of that data, including an additional indefinite extension if a "longer period is required." Upon the submission of the additional data, EPA has three months to review the data after their submission. Upon submission of all the data required for each product to be reregistered, the Administrator has six months to reregister the pesticide or take other appropriate regulatory action.

78. If EPA determines that use of a pesticide is no longer acceptable, two procedures are available to discontinue its use:

Suspension — The agency can notify registrants of its intent to suspend the registration immediately if use of the pesticide would present an "imminent hazard" during the time needed for cancellation. FIFRA § 6(c), 7 U.S.C. § 136d(c), ELR STAT. FIFRA 017. An "emergency suspension" causes the suspension to remain effective pending a hearing and any appeals. FIFRA § 6(c)(3). (Suspension is also an available remedy to EPA under FIFRA §§ 3(c)(2)(B) or 4 for a registrant's failure to comply with data submission requirements without regard to the actual hazards the pesticide may pose.)

Cancellation — The agency can issue a notice of intent to cancel a registration if it believes the pesticide "generally causes unreasonable adverse effects on the environment." FIFRA § 6(b), 7 U.S.C. § 136d(b), ELR STAT. FIFRA 016.

A cancellation may occur without suspension, but all suspensions must be preceded or accompanied by a cancellation notice.

79. Indemnification served other purposes as well. The Agency formerly used claims for indemnification as a way to locate stocks of suspended and canceled pesticides. Although registrants had a financial incentive to inform EPA of the location of such products, submission of indemnity claims was voluntary. Prior to the 1988 amendments, FIFRA contained no requirement or incentive for holders to inform the Agency about products that had only been canceled, or that had been suspended but not yet canceled. The 1988 amendments correct this deficiency. New FIFRA § 6(g) now requires anyone who possesses a pesticide with a canceled or suspended registration to notify EPA of such possession, the quantity, and the place where the pesticide is stored. EPA must decide whether it needs information on every canceled pesticide (including those that are voluntarily canceled) or whether it should announce a lack of interest in reports on some such pesticides.

80. SENATE REPORT, supra note 4, at 7.

81. New FIFRA § 15(b)(1), ELR STAT. FIFRA 025. Congress explicitly restated its intention that the approach adopted in the fiscal year 1988 Continuing Appropriations Act (Pub. L. 100-202) for paying indemnification claims from the "Judgment Fund," rather than EPA's operating budget, would continue. The House Report quoted with approval the conference report on that provision:

The conferees want to make clear that this provision is not intended to change the responsibility of the U.S. Government for indemnification. The conferees understand that claims for indemnification will continue to be submitted by claimants to EPA. The Agency should continue to conduct the technical review of such claims in an expeditious manner to determine the validity of amounts claimed. Claims will then be referred by EPA to the Department of Justice under 28 U.S.C. § 2414 for settlement (or for litigation if the liability or amount are disputed by the Government) and paid pursuant to 31 U.S.C. § 1304. The conferees expect that claims which EPA deems valid should be processed routinely by the Justice Department and that approved claims should be paid promptly from the Judgment Fund of the Treasury.

HOUSE REPORT, supra note 49, at 33. There still remains some ambiguity in the statute between the rights of registrants to receive indemnification and the need for congressional appropriation. See ID. at 77 (potential for litigation if funds are not appropriated).

82. New FIFRA § 15(b)(2), ELR STAT. FIFRA 025. The amendments require that anyone selling a registered pesticide to anyone other than an end user must promise to reimburse the purchaser in the event of a suspension or cancellation unless a written notice is given at the time of sale that the pesticide's cost would not be reimbursed. Notably, this provision for reimbursement of dealers and distributors applies to losses occasioned by suspension, cancellation, or both, whereas indemnification applies only for cancellation and suspension. End users and registrants may obtain government indemnification under the amended FIFRA only if both suspension and cancellation occurs. It is unclear whether "end users" include commercial applicators of pesticides. Compare SENATE REPORT, supra note 4, at 67, with the House floor debate, 134 CONG. REC. H7823-H7826 (daily ed. Sept. 20, 1988).

83. Hearings on EPA's Pesticide Indemnification and Disposal Program Before the Subcommittee on Environment, Energy, and Natural Resources of the House Committee on Government Operations, 100th Cong., 1st Sess. 2 (1987).

84. See supra note 81.

85. See 134 CONG. REC. S13457 (daily ed. Sept. 29, 1988) (remarks by Senator Lugar).

86. HOUSE COMMITTEE ON GOVERNMENT OPERATIONS, SOARING SUBSIDIES FOR BANNED PESTICIDES STYMIE SAFETY REVIEWS, Rep. No. 459, 100th Cong., 1st Sess. 14 (1987).

87. The cost of disposal for the three pesticides is estimated to exceed $ 195 million. HOUSE REPORT, supra note 49, at 31. EPA has disposed of most of the 2, 4, 5-T/silvex stocks, constituting approximately 1.4 million pounds of granular material and 35,000 gallons of liquid material. EDB, suspended in 1983, remains in storage pending development of safe disposal. Approximately 3 to 5 million gallons of dinoseb, suspended in 1986, are being collected, stored, and will ultimately be disposed. See Hearings on EPA's Pesticide Indemnification and Disposal Program Before the Committee on Government Operations, Subcommittee on the Environment, Energy and Natural Resources, 100th Cong., 1st Sess. 3-24 (1987) (statement of John A. Moore, Asst. Administrator for Pesticides and Toxic Subtances).

88. HOUSE REPORT, supra note 49, at 78 (analysis by Congressional Budget Office).

89. The pre-1988 version of FIFRA § 19(a) also purported to authorize EPA to issue regulations governing the storage and disposal of canceled pesticides, but no provision of FIFRA made it unlawful to violate such a regulation. New FIFRA § 12(a)(2)(S) corrects this omission by stating that it is unlawful for any person "to violate any regulation issued under … section 19."

90. The broad new § 19(a)(2) authority is theoretically applicable to any holder of a canceled pesticide, whether the holder is a manufacturer, distributor, or user of the pesticide. It is reasonable to expect that in the future pesticide purchasers at all commercial levels will take this new potential financial liability into account when they negotiate the terms of their pesticide purchase contracts. A similarly broad authority is granted to EPA by the new law to prescribe requirements to be followed by any person who elects to store or transport a pesticide whose registration has been either suspended or canceled, and again it is predictable that purchasers will seek to allocate this risk by contract terms.

91. New FIFRA § 19(f)(1)(B), (f)(3), and (h), ELR STAT. FIFRA 029. It is unclear what impact the references to the Resource Conservation and Recovery Act (RCRA) will have on FIFRA disposal actions. 42 U.S.C. §§ 6901-6991i, ELR STAT. RCRA 001-046. While RCRA § 1006(b) requires EPA to "integrate" the provisions of that Act with other federal environmental laws, nothing in RCRA repeals or supercedes the provisions of FIFRA. Many of the current disposal requirements promulgated by EPA under RCRA and FIFRA overlap or conflict.

92. New FIFRA § 19(b)(1), ELR STAT. FIFRA 028. In establishing such a prerequisite for either recall, Congress implicitly acknowledged that some canceled and suspended products might not be recalled. It is not clear how EPA may choose to implement the provision. Formerly, FIFRA did not give EPA explicit authority to require product recalls, although some cancellation or suspension orders encouraged recalls. Often, pesticides were permitted to be used until supplies were exhausted, on the assumption that limited use over the country was environmentally preferable to concentration of the product through recall and disposal. Support for this approach arguably is furnished by the environmental and health risks posed by centralized storage of stocks of 2,4,5-T/silvex and EDB. See Hearings on EDB Pesticide Disposal Problems Before the Subcommittee on Environment, Energy, and Natural Resources of the House Committee on Government Operations, 99th Cong., 2d Sess. (1986). Environmentalists and others have questioned the logic of suspending and canceling a pesticide as an imminent hazard and unreasonable risk, yet allowing continued use of existing stocks.

93. New FIFRA § 19(b)(2), ELR STAT. FIFRA 028. The required contents of a voluntary recall plan and the participants in it are not defined in the amendments, except for an identification of the level in the distribution chain to which the recall will extend, the schedule for recall, and means to verify the recall's effectiveness. EPA must approve a voluntary plan unless the Agency determines, after an informal hearing, that the plan is "inadequate" to protect the public health or the environment. Id. It is unclear what hearing rights those who are included in a voluntary recall plan have, if any, if the plan is approved. The lack of explicit requirements and bias toward approving voluntary recall plans presumably reflects Congress' recognition that registrants are more familiar than EPA with their own pesticide distribution systems.

94. New FIFRA § 19(b)(3), ELR STAT. FIFRA 028. A mandatory recall plan may apply to the product's registrant, distributors, sellers, or any successor in interest. The regulation may require such persons to establish storage facilities and inform EPA of their locations, store the recalled products, provide transportation, and publicize the recall program. New FIFRA § 19(b)(4), ELR STAT. FIFRA 028. A registrant is not liable for recall and related activities for any pesticide other than its own. Similarly, a distributor or seller is not responsible for pesticides that it did not hold or sell. New FIFRA § 19(d)(3), ELR STAT. FIFRA 029.

95. Omitted in both the voluntary and mandatory recall provisions is a statutory requirement that the product be disposed, recognizing that recalled products may be reprocessed for their chemical value, used for purposes other than a pesticide, or lawfully exported.

96. New FIFRA § 19(c), ELR STAT. FIFRA 028. The scheme providing for reimbursement for the costs of storage of recalled products is complicated. A registrant who wishes to be eligible for reimbursement must submit a storage and disposal plan that meets criteria established by regulation as soon as practicable after the suspension. Notably, registrants of products whose registrations are suspended but not ultimately canceled, canceled without first being suspended, or not recalled receive no reimbursement for storage. Upon meeting the prerequisites of submitting a timely plan that meets EPA's criteria, storing the product, and paying for the storage, registrants are entitled to be reimbursed:

* nothing for costs incurred before the plan was submitted.

* 100% between (i) the later of when the plan was submitted or when the product was canceled, and (ii) before the plan is approved.

* 50% for the first year after the plan was approved or when product was canceled, which ever is later.

* nothing for the next three years.

* 25% thereafter until a disposal permit is granted or alternate disposal plan developed.

While the amendments provide that nothing precludes private agreements to allocate the costs of transportation, storage, and disposal, the reimbursement provision for storage applies only to registrants. New FIFRA § 19(c) and (d)(1), ELR STAT. FIFRA 028.

97. The complexity of the management of pesticide wastes and containers is just beginning to be understood and addressed. The technical and logistic challenges alone are staggering: pesticides vary in toxicity and physical form; containers differ inshape, size, and composition; the persons affected range from farmers, urban users, utilities, and industry to the government itself. EPA estimates that over 220 million empty pesticide containers were created in 1986: 50 percent from home and garden products, 40 percent from agriculture, and 10 percent from industrial and government operations. Adding to the complexity are often overlapping and contradictory laws and authorities. Several states, such as Maine, Oregon, and Iowa, already are active in studying and regulating pesticide container disposal. A useful discussion of this emerging issue is contained in Managing Pesticide Wastes: Recommendations for Action, July 1988 (a summary of two national conferences and four regional workshops attended by government, user, and pesticide industry representatives) (available from NACA).

98. GAO REPORT, supra note 1, at 35.

99. Hearings on S.1516 Before the Senate Committee on Agriculture, 100th Cong., 1st Sess. 164-165 (Apr. 29, May 20, and July 30, 1987).

100. Although the 1988 amendments did not change the pesticide registration criteria, Congress did direct EPA to examine methods to test for pesticides' possible neurotoxic and behavioral effects. HOUSE REPORT, supra note 49, at 33.

101. HOUSE REPORT, supra note 49, at 28.

102. Hearings Before the Subcommittee on Energy and Agriculture of the House Committee on Small Business, Pesticide Registration Fees, Ser. No. 100-30, 100th Cong., 1st Sess. (Nov. 3 and 5, 1987).

103. Some observers believe that the timing of fee payments is more important than their amount. Assessment of significant fees early in reregistration would cause registrants to reassess earlier their commitment to certain products. This potential for voluntary abandonment of registrations was seen as desirable in assisting EPA's reregistration task. While no doubt reduction in the number of product registrations by the pressure of early fees is possible, it is hardly likely in most cases. The fees are simply not large enough in themselves to affect products being actively marketed. Early composition of reregistration fees (or even the relatively small annual maintenance fees) may, however, lead to the abandonment of registrations being held for purely speculative purposes.

104. New FIFRA § 4(i)(4), ELR STAT. FIFRA 014.

105. New FIFRA § 4(d)(5)(B)(i), ELR STAT. FIFRA 011.

106. EPA is not charged with conducting tests on needed but orphaned products. Compare, e.g., Birth Defect Prevention Act of 1984, California Food and Agriculture Code, §§ 13121 et seq.

107. The 1988 amendments attempted elsewhere to assist these generic producers by adding new FIFRA § 3(c)(3)(B), ELR STAT. FIFRA 007. Registration is a necessary barrier to the introduction of new products, even those substantially the same as or identical to existing registered products. These products may be ones introduced by competing manufacturers or by existing registrants who see a market for a slightly modified product. While "delays" may be due to real differences between products, the perception has been that pro forma administrative review, having little to do with new health or environmental concerns, should be much quicker. "Fast-track" for "me-too" registrations only applies to end-use pesticides that would be identical or substantially similar to currently registered pesticides, or would differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment. Other registrations that do not require scientific review of data may be given "fast-track" review. Products like those that are under interim administrative review or that raise prudent concerns of unreasonable risk are not entitled to expedited registration. See HOUSE REPORT, supra note 49, at 31. Within 45 days of receipt, EPA must notify the applicant that the application is complete or, if the application is incomplete, reject it. EPA must also grant or deny a complete application within 90 days of receipt. The standard for registration remains unchanged. SENATE REPORT, supra note 4, at 31. Two million dollars of the total revenue collected each year from the active ingredient and maintenance fees go to supporting EPA's fast-track registration effort.

19 ELR 10070 | Environmental Law Reporter | copyright © 1989 | All rights reserved