The Food Quality Protection Act: A New Way of Looking at Pesticides

Kenneth Weinstein, Jeffrey Holmstead, William Wehrum, and Douglas Nelson

Editors' Summary: In 1996, the Food Quality Protection Act (FQPA) made major changes in the law governing pesticide residues in food, including elimination of the zero-risk standard for carcinogenic food additives. The FQPA instead imposed a new safety standard — a reasonable certainty that no harm will result from aggregate exposure to the pesticide — for establishment of "tolerances" setting maximum allowable amounts of pesticide residue.

In this Article, the authors assess the significant regulatory challenges this new standard poses. They examine the factors EPA must consider in establishing tolerances, including information on the aggregate exposure to a given pesticide and the cumulative effects of pesticides with a common mechanism of toxicity. The authors trace EPA's efforts to begin implementation of the new law and explore the practical and scientific difficulties of developing reliable information on which to base tolerance decisions. They conclude that establishment of tolerances under the FQPA will be challenging, but workable, if EPA relies on and provides sufficient time for collection of good data.

Kenneth Weinstein, Jeffrey Holmstead, and William Wehrum practice environmental law with the Washington, D.C., office of the law firm of Latham & Watkins. Douglas Nelson is Senior Vice President and General Counsel of the American Crop Protection Association.

[28 ELR 10555]

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)¹ and the Federal Food, Drug, and Cosmetic Act (FFDCA)² are the cornerstones of U.S. food safety law. These laws work in tandem to regulate the production, importation, and use of pesticides in the United States.³ In the broadest sense, these statutes and the associated regulations attempt to strike a balance between maximizing the many important benefits derived from pesticides (e.g., enhancing the diversity and abundance of the food supply) and minimizing the potential health and environmental risk associated with their use.

Both FIFRA and the FFDCA have been amended many times over the years to accommodate evolving science and technology and to reflect changing ideas about the role of government in protecting public health and the environment. The most recent changes occurred in 1996, when Congress enacted the Food Quality Protection Act (FQPA).⁴ While the FQPA included many important changes and additions to FIFRA, its most sweeping and controversial aspect was the wholesale rewrite of § 408 of the FFDCA,⁵ which calls for the U.S. Environmental Protection Agency (EPA) to establish "tolerances" prescribingthe maximum amount of pesticide residue allowed in food.⁶

This Article summarizes the key changes in § 408 of the FFDCA and analyzes how these changes will affect EPA, producers and users of pesticides, and others with an interest in the process of establishing and maintaining tolerances under the FFDCA.

"Repeal" of the Delaney Clause and Institution of a New Standard of Safety

One of the principal drivers behind passage of the FQPA was the desire to replace the outdated "Delaney Clause" with a protective, yet workable and more flexible, safety standard.⁷ Before enactment of the FQPA, pesticide residues [28 ELR 10556] in processed foods were considered "food additives." If pesticide residues concentrated in a processed food, FFDCA § 409⁸ required establishment of a separate tolerance. The Delaney Clause of § 409 prohibited the establishment of food additive tolerances for carcinogenic pesticide residues. In effect, the Delaney Clause imposed a "zerorisk" standard for all potentially carcinogenic pesticides subject to the requirements of § 409.

EPA was reluctant to implement the Delaney Clause rigidly, however, because it would have ultimately required the revocation of § 409 tolerances for many valuable pesticides that posed insignificant risks to human health. In the face of EPA's reluctance, the state of California and several public interest groups filed suit against the Agency seeking to compel implementation of the Delaney Clause.⁹ Under the terms of a negotiated settlement, EPA agreed to a schedule that called for the eventual revocation of all § 409 tolerances for pesticides that had been determined to be carcinogens.

With this as a backdrop, Congress stepped in to revise the way that EPA establishes tolerances for pesticide residues in processed food. Congress accomplished this by making two major changes to the FFDCA. First, the FQPA "repealed" the Delaney Clause as applied to pesticides by excluding pesticide residues from the definition of "food additive" in § 201(s).¹⁰ In other words, because pesticide residues are no longer considered food additives, they are no longer subject to § 409 and the Delaney Clause.

The FQPA also revised the § 408 standard of safety. Before this revision, when establishing tolerances under § 408, EPA was required to consider not only the risks to public health, but also certain benefits, such as the necessity to produce an adequate, wholesome, and economical food supply. The FQPA imposed a new standard of safety, located in § 408(b)(2), requiring establishment of tolerances at a level that provides a "reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposure and all other exposures for which there is reliable information."¹¹ The new standard does not generally allow for the consideration of benefits.¹²

The legislative history of the "reasonable certainty of no harm" standard,¹³ as well as the history of the use of this standard by the Food and Drug Administration (FDA),¹⁴ expresses an understanding that proof of safety to an absolute certainty under all conditions of use is not scientifically possible. It was expected that scientific experts would weigh all available information and approve the use of substances that they believed were reasonably certain not to harm humans.¹⁵ Congress enacted the FQPA on the assumption that EPA would continue to apply this long-standing approach to determining a reasonable certainty of no harm, and that the new law would codify this approach.¹⁶

The net result of these changes is that the FQPA effectively established a "single regulatory framework" for both raw and processed foods.¹⁷ As a practical matter, it appears that this new framework represents a more stringent approach to setting tolerances under the FFDCA. On one hand, because the Delaney Clause no longer applies to pesticide residues that concentrate in processed foods, the unyielding zero-risk standard no longer looms over several important pesticides. On the other hand, tolerances for practically all pesticides must now be established according to a standard of safety that does not allow for consideration of their benefits. In addition, as discussed in more detail below, EPA must consider several new factors in establishing tolerances and must reconsider all existing tolerances according to a very ambitious 10-year schedule.

All told, the repeal of the Delaney Clause as it applied to pesticide residues solved one difficult problem that faced a limited number of pesticides, yet led to the creation of several new problems that will challenge the Agency, pesticide makers and users, and other interested parties for many years to come.

New Factors That Must Be Considered in Establishing Tolerances and the Emphasis on Actual Information

In addition to consolidating the tolerance requirements for raw and processed foods and creating a new standard of safety, the FQPA imposed a number of new requirements governing the establishment of tolerances under § 408 of the FFDCA.¹⁸ For example, EPA is now expressly required to take into account the unique exposures and special susceptibility of infants and children when establishing tolerances.¹⁹ Additionally, § 408 now includes a list of nine factors that EPA must consider in establishing tolerances. Of particular importance is the requirement that the Agency consider available information on the aggregate exposure to a given [28 ELR 10557] pesticide and the cumulative effects of pesticides with a common mechanism of toxicity.

A consistent element of these and other new requirements related to establishing tolerances is an emphasis on the use of "available" and "reliable" information in making tolerance decisions. In the report accompanying the legislation, the FQPA drafters emphasized that "[s]ound, verifiable scientific analysis is critical to ensuring rational regulatory decisions."²⁰

This section summarizes the key FQPA provisions governing establishment of tolerances and assesses how these provisions should work together to ensure that EPA makes informed decisions based on reliable information.

Summary of Key Tolerance-Setting Requirements

Section 408 of the FFDCA, as amended by the FQPA, includes several related provisions that together prescribe the method by which EPA must make tolerance decisions. Below are summaries of the key tolerance-setting requirements.

[] The New Safety Standard. As explained in more detail above, § 408(b)(2)(A)(i) provides that EPA may establish or leave in effect a tolerance only if the tolerance is determined to be "safe."²¹ Section 408(b)(2)(A)(ii) defines "safe" to mean that there is a "reasonable certainty that noharm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information."²²

[] Exposure of Infants and Children. Section 408(b)(2)(C) requires EPA to assess the risk of the pesticide chemical residue to infants and children based on available information on (1) consumption patterns, (2) special susceptibility, and (3) the cumulative effects of such residues and other substances that have a common mechanism of toxicity.²³ In addition, EPA must ensure that there is a reasonable certainty of no harm to infants and children from aggregate exposure to the pesticide chemical residue and publish a specific determination regarding the safety of the pesticide chemical residue for infants and children. Most importantly, for threshold health effects, EPA must impose an additional tenfold safety factor for infants and children to take into account pre- and postnatal toxicity and completeness of the data, unless reliable data show that a different margin will be safe.²⁴

[] Factors to Be Considered in Establishing Tolerances. The new law requires EPA to consider nine factors in setting tolerances. The nine factors are: (1) the validity, completeness, and reliability of the studies; (2) toxic effects caused by the pesticide; (3) available information on human risk; (4) available information on dietary consumption of consumers and major identifiable subgroups; (5) available information on the cumulative effects of the pesticide residue and other substances having a common mechanism of toxicity; (6) available information on aggregate exposure of consumers to the pesticide and to other related substances, including dietary exposure as well as exposure from other nonoccupational sources; (7) available information on the variability of the sensitivities of major identifiable subgroups of consumers; (8) information that EPA requires on estrogenic effects; and (9) appropriate safety factors.²⁵ Five of these factors require EPA to consider information only to the extent that it is "available."²⁶

[] Data Regarding Dietary Exposures. The FQPA contains two provisions specifically addressing the data used by EPA to assess dietary exposures. Section 408(b)(2)(E) of the FFDCA provides that the Agency may consider available data and information on the anticipated residue levels of the pesticide chemical in or on food and the actual residue levels that have been measured.²⁷ If EPA does so, data must be provided five years after the tolerance is established (and thereafter as EPA finds appropriate) demonstrating that the levels are not above those relied on in establishing the tolerance.²⁸ Similarly, § 408(b)(2)(F) states that EPA may, when assessing chronic dietary risk, consider available data and information on the percent of food actually treated.²⁹ If this is done, EPA must meetspecified requirements regarding the reliability and validity of the available data, and must periodically reevaluate the estimate of anticipated dietary exposure.³⁰

[] Special Data Requirements. Section 408(f)(1) requires EPA to seek additional data if such data are reasonably required to support the continuation of a tolerance.³¹ EPA may seek the additional data by issuing a "data call-in" under FIFRA § 3(c)(2)(B), issuing a rule under § 4 of the Toxic Substances Control Act (TSCA),³² or by publishing an order in the Federal Register.³³

Aggregate Exposure and Cumulative Effects From Compounds With a Common Mechanism of Toxicity

The FQPA fundamentally changed the way in which EPA must conduct exposure and risk assessments in establishing tolerances. In the past, EPA's exposure assessments for tolerance decisions typically took into account only a single mode of human exposure — dietary exposure — and considered the anticipated effects only from exposure to the specific pesticide under consideration. In contrast, the FQPA now requires EPA to consider "aggregate exposure" (i.e., exposure not only from dietary sources, but also from other sources such as drinking water and residential uses of the given pesticide). Also, in establishing tolerances, EPA must consider the cumulative effects from multiple compounds with a common mechanism of toxicity. These provisions are among the most technically challenging mandates imposed by the FQPA, in large part because of the lack of information [28 ELR 10558] and experience in assessing aggregate exposure and cumulative risk.

The term "aggregate exposure" appears in three places in the new § 408. The standard of safety laid out in § 408(b)(2)(A)(ii) provides that tolerance determinations must be made in light of the "aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information."³⁴ Under § 408(b)(2)(C)(ii)(I), EPA must ensure that there is a reasonable certainty of no harm to infants and children from aggregate exposure.³⁵ Lastly, § 408(b)(2)(D)(vi) requires EPA, when establishing a tolerance, to consider available information concerning the aggregate exposure levels of consumers, including dietary exposure and exposure from other nonoccupational sources.³⁶

EPA has indicated that it will implement these requirements by focusing on the dietary, drinking water, and residential exposure pathways. In a November 1997 memorandum from Stephen Johnson, Acting Director of EPA's Office of Pesticide Programs, EPA articulated an interim approach for "incorporating a consideration of pesticide exposures via drinking water into tolerance decisionmaking."³⁷ This document lays out a tiered approach to assessing drinking water exposure. Similarly, on July 18, 1997, EPA issued its draft Standard Operating Procedures (SOPs) for Residential Exposure Assessments. This document provides detailed methods for estimating exposure to pesticides from particular residential sources, such as lawn treatments, swimming pools, painting, and pet care.

These documents illustrate the risks of conducting aggregate exposure assessments when comprehensive and reliable actual information is not available. Both rely on estimating techniques that incorporate extremely conservative default assumptions. For example, the first-tier screening model for drinking water exposure uses a hypothetical "farm pond" model that can produce estimated concentrations in drinking water many orders of magnitude greater than actually occur. As a result, the use of such models could put a tolerance in jeopardy on the basis of hypothetical exposures that do not necessarily have any basis in fact. Such unreasonable results would be magnified if conservative assumptions were used for multiple exposure pathways. It is questionable whether unsupported models and assumptions would constitute "reliable" information under the safety standard of § 408(b)(2)(A)(i).

The requirement to consider the cumulative effects from compounds with a common mechanism of toxicity appears in two places in § 408. First, § 408(b)(2)(C)(i)(III) requires EPA to assess the risk of pesticides to infants and children based in part on available information concerning the cumulative effects of the given pesticide and other substances that have a common mechanism of toxicity.³⁸ Similarly, § 408(b)(2)(D)(v) generally requires the Agency to consider available information concerning the cumulative effects of the given pesticide and other substances that have a common mechanism of toxicity.³⁹

In practice, these requirements pose three major challenges. First, EPA must determine which compounds actually have a common mechanism of toxicity. Once this determination has been made, EPA must devise a method for assessing the cumulative effects that result from exposure to these compounds. Finally, if the cumulative effects of these compounds are determined to be unacceptable, then the Agency must decide how to adjust the use patterns for the affected compounds to achieve an acceptable result.

The extreme difficulty of addressing these issues is illustrated by EPA's tentative determination that the organophosphate pesticides (OPs) share a common mechanism of toxicity because they all inhibit cholinesterase. On March 24, 1998, EPA presented a paper to the FIFRA Scientific Advisory Panel (SAP) that outlined proposed general principles for assessing whether compounds have a common mechanism of toxicity, and presented its tentative determination that OPs do in fact share a common mechanism of toxicity.⁴⁰

In its final report on the March meeting, however, the SAP could not reach consensus on EPA's general principles for making common mechanism determinations and stopped short of affirming the Agency's tentative determination as to the OPs.⁴¹ The SAP concluded that EPA's definition of toxicity (which involved the events following interaction of the pesticide with the target molecule) was too narrow in that it precluded consideration of other potentially relevant factors, such as pharmacodynamics, pharmacokinetics, and synergistic or interactive effects. The SAP further concluded that "the most significant challenges lie not in grouping chemicals, but in reducing the concepts to practice."⁴² Thus, the SAP highlighted the complexity of identifying groups of compounds that share a common mechanism of toxicity and emphasized the difficulty of assessing cumulative effects for compounds belonging to such a group.

EPA has had similar difficulty in achieving general consensus on a method of "adjusting" use patterns to achieve an acceptable level of cumulative effects. In a briefing paper for the Office of Pesticide Programs Office Director dated February 5, 1998, EPA staff presented options for mitigating OP "risk."⁴³ The paper appeared to favor the option [28 ELR 10559] that would call for EPA to propose a rule to revoke the tolerances for all OPs and then, on the basis of information provided during the comment period by interested parties, promulgate rules modifying or revoking all tolerances shown not to fit in the collective "risk cup." For obvious reasons, this paper created a storm of protest from pesticide makers, farmers, and the food industry that ultimately led Vice President Gore to issue a directive to the Agency to work with the Secretary of Agriculture to ensure that implementation of the FQPA "is informed by a sound regulatory approach, by the expertise of the Department of Agriculture (USDA), by appropriate input from affected members of the public, and by due regard for the needs of our Nation's agricultural producers."⁴⁴ As a result, EPA convened an advisory committee to consider this as well as a variety of other FQPA implementation issues.

In sum, the requirements to consider aggregate exposure and cumulative effects from compounds with a common mechanism of toxicity have made it much more difficult to establish tolerances under § 408. Informed decisions will require much more information than was historically collected by the Agency for issuing registrations under FIFRA and tolerances under the FFDCA. Moreover, gathering high quality information could take years, depending on the nature of the information and the studies that may be needed to generate that information. It is imperative for EPA to devise an implementation strategy that avoids the use of conservative assumptions and incomplete data and instead promotes informed decisionmaking on the basis of reliable information.

The Mandatory Duty to Seek Additional Data

When Congress passed the FQPA, it was well known that the new factors to be considered in making decisions on tolerances could require far more information than EPA historically collected under FIFRA and the FFDCA. It was equally well known that reliable information on certain issues would simply not be available until there was significant further research on those issues. For example, as discussed above, conclusively establishing a common mechanism of toxicity, even for closely related compounds, is an exercise that currently poses a major challenge to the scientific community.

Knowing all of this, Congress could easily have instructed EPA to use assumptions and scientific best guesses to fill in the data gaps and to bridge areas of uncertainty. The FQPA, however, requires that tolerance decisions be made only on the basis of reliable available information. Section 408(b)(2)(D) of the FFDCA explicitly states that five of the nine factors for making decisions on tolerances may only be considered to the extent the Agency has "available information" on the relevant factor.⁴⁵ For example, aggregate exposure and the cumulative effects of substances with a common mechanism of toxicity may only be considered to the extent that the Agency has "available information."⁴⁶

The FQPA also included, however, an important tool to be used in obtaining relevant and necessary information. Section 408(f)(1) of the FFDCA requires EPA to obtain additional data if such data are reasonably required to support the continuation of a tolerance.⁴⁷ The statute provides three mechanisms for obtaining additional information: the "data call-in" provisions of § 3(c)(2)(B) of FIFRA, a test rule under TSCA, or by rule through notice and comment in the Federal Register. This provision does not simply grant authority to the Agency to obtain additional information where needed. Rather, it is a clear mandate that requires EPA to obtain information through one of the three specified mechanisms when "reasonably required to support the continuation of a tolerance."⁴⁸

The Tenfold Safety Factor to Protect Infants and Children

The FQPA places special emphasis on reducing the risk of pesticide residues to infants and children. Section 408(b)(2)(C) of the FFDCA requires EPA to assess the risk of pesticide chemical residues to infants and children, based on available information about unique consumption patterns, special susceptibility, and the cumulative effects of compounds with a common mechanism of toxicity. When it establishes a tolerance, the Agency must make a specific determination that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. In addition, the Secretary of Health and Human Services and the Secretary of Agriculture, in consultation with the EPA Administrator, must conduct surveys to document dietary exposure to pesticides among infants and children.⁴⁹

Most importantly, EPA must apply an additional tenfold margin of safety for threshold effects on infants and children to take into account potential pre- and postnatal toxicity and completeness of data. Even if there is such toxicity or the data are not complete, EPA may apply a different margin, if justified on the basis of reliable data. Congress emphasized that EPA should interpret these requirements according to the recommendations of the National Research Council's study, Pesticides in the Diets of Infants and Children.⁵⁰ That report observed that EPA typically applies a third uncertainty factor⁵¹ whenever the available information indicates fetal developmental effects. The report concludes that the additional tenfold factor to protect infants and children should also be considered when there is evidence of postnatal developmental toxicity and when data from toxicity testing relative to children are incomplete.⁵²

[28 ELR 10560]

Immediately prior to enactment of the FQPA, EPA Assistant Administrator Lynn Goldman sent letters explaining the Agency's understanding of these new requirements to Rep. Thomas Bliley (R-Va.), Chairman of the House Committee on Commerce,⁵³ and to Sen. Richard Lugar (R-Ind.), Chairman of the Senate Committee on Agriculture, Nutrition, and Forestry.⁵⁴ In these letters, Dr. Goldman indicated that the provision was consistent with then-current Agency risk assessment practices and that EPA would apply an additional factor of 3 to 10 based on how much information is incomplete. She noted that EPA would not apply an additional safety factor when reproductive and developmental data are acceptable and do not indicate effects of concern.

Subsequently, on February 25, 1998, EPA Administrator Carol M. Browner and EPA Deputy Administrator Fred Hansen issued a memorandum that provided more affirmative instructions to EPA staff as to how decisions on the tenfold safety factor are to be made — instructions that appear to mark a change in the Agency's approach to implementing this factor.⁵⁵ The memorandum explained that when there is uncertainty as to the need for additional studies, uncertainty itself mandates application of the tenfold safety factor. Additionally, the tenfold safety factor should be used when there are severe effects or heightened exposures for children.

Dr. Goldman then elaborated on the Agency's view in a letter to Rep. Henry A. Waxman (D-Cal.).⁵⁶ Dr. Goldman explained that "EPA has required, by regulation, a basic core set of toxicity and exposure data since 1984."⁵⁷ These data include at least one reproductive toxicity study and two developmental toxicity studies, as well as other acute, subchronic, and chronic studies. In addition, EPA may call for other studies or information where existing information indicates the need.⁵⁸ If EPA determines that available information is insufficient, either the tolerance will not be granted or the tenfold factor will be applied.⁵⁹

Materials that EPA prepared for the March 25, 1998, Office of Pesticide Programs SAP meeting contain a much more detailed discussion of EPA's proposed approach to implementing the tenfold safety factor. In a paper titled Presentation for FIFRA Scientific Advisory Panel by Office of Pesticide Programs, Health Effects Division on FQPA Safety Factor for Infants and Children,⁶⁰ the Agency explained that it will conduct a weight-of-evidence evaluation on the basis of all applicable data and sound scientific judgment and principles. In its response, the SAP encouraged the Agency to refine its approach and return it to the SAP for further consideration.⁶¹

While EPA is still developing its approach for determining whether to apply an additional safety factor to protect infants and children, the final policy will almost certainly require consideration of two principal issues: (1) whether "complete" information is available, and (2) whether the available information indicates that infants or children have special susceptibility. Much of the debate to date has centered on the first issue — the question of what constitutes "complete" information.

This is an issue of great practical importance because it can take months or years to conduct the studies that may be required. If EPA determines that sufficient information is not available to make an informed decision, then there may not be time to generate that information before the Agency moves forward with the given tolerance decision. Under such an approach, § 408(b)(2)(C) would create "instant" data gaps that would impel the Agency to impose the tenfold factor for lack of information that could be developed, but not within the time frame provided by the Agency's schedule for acting on tolerances.

Interpreting the FQPA in the context in which it was enacted avoids such unreasonable results. In particular, it has been a long-standing EPA practice to rely on the FIFRA data requirements promulgated at 40 C.F.R. Part 158 for issuing tolerances under the FFDCA. If data beyond those prescribed by Part 158 were needed, the Agency would obtain those data by issuing a data call-in to the affected parties pursuant to FIFRA § 3(c)(2)(A) and (B). These provisions state that "the Administrator shall permit sufficient time for applicants to obtain such additional information."⁶² Consistent with this requirement, the Agency has not historically placed a registration or tolerance in jeopardy due to the existence of a data gap without first providing a reasonable amount of time for generation of the needed data.

EPA affirmed this approach to the tenfold safety factor in its briefing paper for the March 1998 SAP meeting when it observed that, "[f]or a food-use chemical, core data requirements are specified in 40 C.F.R. Part 158." The Agency further indicated that a "data call-in" should be used if additional data, such as a developmental neurotoxicity test, are needed.⁶³

Moreover, the FQPA itself prescribes this approach. As discussed above, § 408(f)(1) provides that EPA must seek additional information when such information is reasonably required to support the continuation of a tolerance. Three mechanisms to obtain such information are provided, including the data call-in provisions of FIFRA § 3(c)(2)(B).

[28 ELR 10561]

Thus, when placed in the context of long-standing Agency practices, the requirements of § 408(b)(2)(C) should be interpreted in a way that avoids the problems associated with the creation of instant data gaps. Specifically, EPA should view data for a given pesticide as complete for purposes of determining the need for the additional tenfold safety factor to protect infants and children, if all of the data required by Part 158 are available. When EPA determines that additional data are needed, it should seek that information (and provide a reasonable amount of time to obtain that information) under the authority of § 408(f).

Statutory Timing for Reassessing All Existing Tolerances

Among the most ambitious changes imposed by the FQPA is the requirement for EPA to reassess all existing tolerances within 10 years after the FQPA enactment date (i.e., by August 3, 2006). Specifically, § 408(q) of the FFDCA requires EPA to review all tolerances and exemptions in effect on August 3, 1996, as expeditiously as possible under the new FQPA safety standard.⁶⁴ The Agency must conduct the reviews in three phases: (1) one-third within 3 years, (2) two-thirds within 6 years, and (3) all within 10 years. Before the expiration of the applicable review period, EPA must issue regulations modifying or revoking tolerances and exemptions that do not meet the new safety standard. In conducting these reviews, EPA must give priority to those tolerances and exemptions that appear to pose the greatest risk to public health.

EPA published a schedule for tolerance reassessments on August 4, 1997.⁶⁵ The Group 1 pesticides — those scheduled for reassessment within three years — include OPs, carbamates, probable human carcinogens, high-hazard inert ingredients, and pesticides that, based on the best available data at the time of scheduling, appear to exceed their respective reference doses. The Group 2 pesticides — scheduled for reassessment within six years — include possible human carcinogens not included in Group 1. The remaining group, Group 3, consists of biological pesticides, inert ingredients that are not high-hazard inerts, and all other post-1984 pesticides with tolerances or exemptions not yet reassessed under the FQPA.

According to EPA estimates, there are a total of about 20,000 registered pesticide product formulations, with close to 500 pesticide active ingredients used in agriculture. Because a separate tolerance is required for each different crop use, more than 9,000 tolerances have been established for pesticides.⁶⁶ Thus, to meet the statutory schedule for reassessing all existing tolerances, EPA will need to average more than 3 tolerance reassessments per working day for the entire 10-year period.⁶⁷

Even under the best of circumstances, this would be a daunting task. The schedule will be particularly challenging, however, in light of the many new substantive requirements imposed by the FQPA, such as the requirements to consider aggregate exposure and the cumulative effects from compounds with a common mechanism of toxicity. Additionally, since the FQPA required EPA to front load the tolerance reassessment schedule with some of the most widely used and difficult to assess pesticides, the Agency will not have much time to develop its new policies and procedures before having to tackle some of the toughest issues. To make matters worse, more than two years of the first three-year period have passed and the Agency has not yet issued a tolerance reassessment for any existing tolerance under the FQPA.

All told, EPA is under tremendous pressure to make thousands of complex determinations in an unreasonably short period of time. One real danger is that poor quality data and unrealistically conservative assumptions will take the place of actual, reliable information when the Agency makes tolerance determinations under the FQPA schedule. As noted above, it can take years to develop the kind of high-quality data on which EPA has historically relied in making tolerance decisions. Providing such time to gather needed information could quickly put the Agency behind schedule. Yet not providing adequate time to gather reliable information could unfairly put many safe and effective tolerances in jeopardy.

EPA has at least three ways, however, to meet the statutory schedule while making informed and fair decisions. First, § 408(e)(1)(A) and (B) provide that the EPA Administrator may initiate tolerance rulemakings on her own initiative.⁶⁸ This empowers the Agency to take a two-step approach to assessing tolerances under the FQPA. First, to meet the statutory reassessment schedule, EPA could gather all of the readily available and reliable information and, on the basis of such information, conduct tolerance reassessments according to the schedule. After this initial review, EPA could then seek additional potentially relevant information for particular tolerances and, if justified in light of such information, initiate a subsequent rulemaking to amend these tolerances as needed.

Section 408(g)(1), which states that a regulation establishing a tolerance shall take effect on publication, unless the regulation or order specifies otherwise, provides a second possible approach.⁶⁹ This provision plainly gives EPA the authority to establish deferred effective dates for tolerance determinations. In circumstances where additional data or information are needed to make an informed tolerance determination, the Agency could promulgate a tentative tolerance determination within the time provided by the statutory reassessment schedule, but defer the effective date until it obtains the additional data or information. If the additional data validate the Agency's preliminary determination, the rule could become effective as promulgated. If the additional data supported a different result, then the Agency could promulgate a new determination that would supersede the deferred determination.

A third flexible timing option is based on § 408(f)(l)(A). This provision authorizes the Agency to seek additional data under § 3(c)(2)(B) of FIFRA when additional data or information are reasonably required to support the continuation of a tolerance.⁷⁰ Section 3(c)(2)(B) in turn anticipates that registrants will be given adequate time to produce needed information before their registrations or tolerances [28 ELR 10562] are put in jeopardy.⁷¹ Section 3(c)(2)(A), which is a necessary predicate to § 3(c)(2)(B), expressly provides that EPA shall allow sufficient time to obtain needed information.⁷² The only reasonable way to give meaning to these provisions is to interpret them as requiring the Agency to provide sufficient time to obtain necessary data, even if the additional time would extend the tolerance decision beyond the general § 408(q) reassessment schedule. These provisions, therefore, effectively provide that EPA must defer the decision on a particular tolerance reassessment for the period necessary to obtain information.

In sum, EPA has several legally and practically workable methods of providing sufficient time to carry out the generation of data needed to make informed decisions for tolerance reassessments. The continuation of tolerances for many safe and effective pesticides depends on the Agency's ability and willingness to provide a reasonable amount of time for data gathering.

Conclusion

The FQPA fundamentally changed the standards for establishing tolerances for pesticide residues in food. While it facilitated the issuance of tolerances for certain pesticides by eliminating the zero-risk Delaney Clause standard as it applied to pesticide residues in food, the FQPA included a number of other provisions that, in the aggregate, make the issuance of tolerances much more complex. When the ambitious statutory schedule for reassessing all existing tolerances is factored in, implementing the FQPA will be a substantial challenge, but nevertheless can be effectively accomplished if the statute is interpreted in a manner that is consistent with historical practices and that gives high regard to the importance of sound science in tolerance decisionmaking.

1. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA §§ 2-34.

2. 21 U.S.C. §§ 301-395.

3. Under § 2(u) of FIFRA, a "pesticide" is "(1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer, except that the term 'pesticide' shall not include any article that is a 'new animal drug' within the meaning of section 201(2) of the [FFDCA] …." 7 U.S.C. § 136(u), ELR STAT. FIFRA § 2(u). As the title of the Act suggests, the term "pesticide" is broadly defined to include insecticides, fungicides, and rodenticides, as well as other categories of compounds, such as herbicides.

4. Pub. L. No. 104-170, 110 Stat. 1489 (1996).

5. 21 U.S.C. § 346a.

6. § 405, 110 Stat. at 1514.

7. See H.R. REP. No. 104-669, pt. 2, at 29 (1996).

8. 21 U.S.C. § 348.

9. See California ex rel. Van de Kamp v. Reilly, 750 F. Supp. 433 (E.D.Cal. 1990). See also Les v. Reilly, 968 F.2d 985, 22 ELR 21303 (9th Cir. 1992), cert. denied, 113 S. Ct. 1361 (1993).

10. 21 U.S.C. § 321(s). Note that the Delaney Clause was not deleted from § 409; the prohibition against establishing tolerances for carcinogenic food additives remains in place. Because pesticide residues are no longer considered food additives, § 409 and the Delaney Clause do not apply to pesticide residues.

11. Id. § 346a(b)(2).

12. Note that FFDCA § 408(b)(2)(B) provides that EPA may consider benefits for "eligible" pesticide residues. Id. § 346a(b)(2)(B). To be eligible, a pesticide must meet three criteria: (1) it must have an existing tolerance, (2) it must be a carcinogenic pesticide that poses a nonnegligible risk, and (3) the pesticide's noncarcinogenic risks must pass the new safety standard. Additionally, for EPA to consider benefits for an eligible pesticide, two sets of conditions must be met: one concerning the need for the pesticide and a second concerning the risk posed by the pesticide. In short, the criteria for consideration of benefits are stringent.

13. H.R. REP. No. 104-669 (1996), reprinted in 1996 U.S.C.C.A.N. 1208.

14. The FDA is responsible for implementing the provisions of the FFDCA applicable to drugs and cosmetics.

15. H.R. REP. No. 85-2284, at 4 (1958); S. REP. No. 86-795, at 9 (1959).

16. In the House report accompanying the FQPA legislation, Congress explained its understanding of EPA's current approach to determining a reasonable certainty of no harm. For threshold effects, a tolerance will provide a reasonable certainty of no harm if the aggregate exposure will be lower by an ample margin of safety than the level at which the compound will not cause or contribute to harm to human health. When extrapolating from animal studies, a 100-fold safety factor below the no observable effect level is considered an ample margin of safety. For nonthreshold effects that can be assessed through quantitative risk assessment, a reasonable certainty of no harm is provided if any increase in lifetime risk will be no greater than "negligible." Negligible risk is interpreted to be one in a million. H.R. REP. No. 104-669, pt. 2, at 40-41.

17. Id. at 39.

18. In this Article, the term "establishing tolerances" includes establishing a new tolerance and continuing, revising, or revoking an existing tolerance.

19. Even before this change, it was EPA practice to consider the variability among humans in setting an appropriate margin of safety.

20. H.R. REP. No. 104-669, pt. 1, at 37.

21. 21 U.S.C. § 346a(b)(2)(A)(i).

22. Id. § 346a(b)(2)(A)(ii).

23. Id. § 346a(b)(2)(C).

24. Id.

25. Id. § 346a(b)(2)(D).

26. Id. § 346a(b)(2)(D)(iii)-(vii).

27. Id. § 346a(b)(2)(E).

28. Id.

29. Id. § 346a(b)(2)(F).

30. Id.

31. Id. § 346a(f)(1).

32. 15 U.S.C. § 2603, ELR STAT. TSCA § 4.

33. 21 U.S.C. § 346a(f)(1).

34. Id. § 346a(b)(2)(A)(ii).

35. Id. § 346a(b)(2)(C)(ii)(I).

36. Id. § 346a(b)(2)(D)(vi).

37. Memorandum from Stephen Johnson. Acting Director, Office of Pesticides Programs, U.S. EPA, to EPA Office of Pesticide Division Directors (Nov. 20, 1997).

38. 21 U.S.C. § 346a(b)(2)(C)(i)(III).

39. Id. § 346a(b)(2)(D)(v).

40. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, A COMMON MECHANISM OF ACTION: THE ORGANOPHOSPHATE PESTICIDES (1998).

41. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, SCIENTIFIC ADVISORY PANEL (SAP) MEETING — MARCH 1998 FINAL REPORT (meeting held Mar. 24-25, 1998) http://www.epa.gov/opp00001/SAP/march/finalmar.htm [hereinafter MARCH 1998 FINAL REPORT].

42. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, SCIENTIFIC ADVISORY PANEL (SAP) MEETING, COMMON MECHANISM OF ACTION OF ORGANOPHOSPHATES REPORT 1 (1998).

43. U.S. EPA, Addressing Organophosphate Risk, Briefing of the OPP Office Director (Feb. 5, 1998) (unpublished). This briefing paper illustrates a common misperception about the FQPA requirements governing compounds determined to have a common mechanism of toxicity. Throughout this paper, EPA addresses the need to reduce the cumulative "risk" associated with exposure to OPs, which the Agency assumes share a common mechanism of toxicity. The statute, however, does not use the term "risk" with regard to compounds with a common mechanism of toxicity. Rather, the statute expressly provides, in both FFDCA § 408(b)(2)(C)(i)(III) and § 408(b)(2)(D)(v), that tolerance decisions should be made in light of the cumulative "effects" of exposure to compounds with a common mechanism of toxicity. 21 U.S.C. § 346a(b)(2)(C)(i)(III), (D)(v). Since tolerances are set at levels far below those that would be expected to produce a toxic effect, then it is not at all certain that exposure to multiple compounds with a common mechanism of toxicity at their tolerance levels would necessarily result in any toxic effect (i.e., adding multiple zeros still yields a zero). For the OPs, this effect may be magnified because EPA establishes the tolerances on the basis of measurable cholinesterase inhibition, which, in and of itself, is not necessarily a toxic effect.

44. Memorandum from the Vice President to Daniel R. Glickman, Secretary of Agriculture, and Carol M. Browner, Administrator, U.S. EPA (Apr. 8, 1998) (Food Quality Protection).

45. 21 U.S.C. § 346a(b)(2)(D).

46. Id. § 346a(b)(2)(D)(v) & (vi).

47. Id. § 346a(f)(1).

48. Id.

49. Id. § 346a(b)(2)(C).

50. H.R. REP. NO. 104-669, pt. 2, at 43 (1996).

51. The "third" factor would be in addition to the factors normally applied to account for intraspecies and interspecies variability.

52. H.R. REP. NO. 104-669, pt. 2, at 93.

53. Letter from Lynn R. Goldman, M.D., Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. EPA, to Rep. Thomas Bliley, Chairman, Committee on Commerce, U.S. House of Representatives (July 23, 1996).

54. Letter from Lynn R. Goldman, M.D., Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. EPA, to Sen. Richard Lugar, Chairman, Committee on Agriculture, Nutrition, and Forestry, U.S. Senate (July 23, 1996).

55. Memorandum from Carol M. Browner, Administrator, U.S. EPA, and Fred Hansen, Deputy Administrator, U.S. EPA, to Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, Acting Assistant Administrator, Office of Research and Development, and Director, Office of Children's Health Protection, U.S. EPA (Feb. 25, 1998) (Implementation of Special Children's Protections in Food Quality Protection Act).

56. Letter from Lynn R. Goldman, M.D., Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, U.S. EPA, to Rep. Henry A. Waxman, U.S. House of Representatives (Mar. 17, 1998).

57. Id. at 3.

58. Id. at 2.

59. Id. at 3.

60. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, PRESENTATION FOR FIFRA SCIENTIFIC ADVISORY PANEL BY OFFICE OF PESTICIDE PROGRAMS, HEALTH EFFECTS DIVISION ON FQPA SAFETY FACTOR FOR INFANTS AND CHILDREN (1998) (available from the ELR Document Service, ELR Order No. AD-3706) [hereinafter PRESENTATION FOR FIFRA SCIENTIFIC ADVISORY PANEL].

61. MARCH 1998 FINAL REPORT, supra note 41.

62. 7 U.S.C. § 136a(c)(2)(A) & (B), ELR STAT. FIFRA § 3(c)(2)(A) & (B).

63. PRESENTATION FOR FIFRA SCIENTIFIC ADVISORY PANEL, supra note 60, at 5.

64. 21 U.S.C. § 346a(q).

65. 62 Fed. Reg. 42020 (Aug. 4, 1997).

66. See OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES, U.S. EPA, 1996 FOOD QUALITY PROTECTION ACT IMPLEMENTATION PLAN 4 (1997).

67. This assumes that there are 250 working days per year.

68. 21 U.S.C. § 346a(e)(1)(A) & (B).

69. Id. § 346a(g)(1).

70. Id. § 346a(f)(1)(A).

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

72. Id. § 136a(c)(2)(A), ELR STAT. FIFRA § 3(c)(2)(A).