Implementation of the Food Quality Protection Act ... - ACS Publications

Chapter 13

Implementation of the Food Quality Protection Act of 1996

Downloaded by UNIV MASSACHUSETTS AMHERST on September 26, 2012 | http://pubs.acs.org Publication Date: June 16, 1999 | doi: 10.1021/bk-1999-0724.ch013

Margaret J. Stasikowski and Kathleen A. Martin Health Effects Division (7509C), Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M Street S.W., Washington, DC 20460

The Food Quality Protection Act of 1996 amended both laws under which pesticides are regulated in the United States. Major provisions of the Federal Insecticide Fungicide and Rodenticide Act include a 15-year registration renewal cycle, acceleration of the registration process for 'safer' pesticides, and the establishment of separate programs for minor uses and antimicrobials. Major provisions of the Federal Food Drug and Cosmetic Act include a single, health-based standard for residues on all foods, special considerations for infants and children, a schedule for reevaluation of all existing tolerances, testing for endocrine disruptors, uniformity of tolerances, and enhanced enforcement capabilities for the Food and Drug Administration. How the Agency has been implementing the new law will be described, with particular emphasis onriskassessment and science policy aspects.

The Food Quality Protection Act of 1996 (FQPA) is a law that was enacted by the President on August 3, 1996, (I) to enhance the safety of the American food supply. It is the most significant piece of pesticide and food safety legislation enacted in many years. In fact, FQPA is the first major revision of pesticide laws in over 30 years. This law is so important because it reflects a national commitment to greater protection of infants and children from the possible effects of pesticide residues in food. FQPA is also important because it introduces a good measure of common sense into the process of pesticide regulation by recognizing that the state-of-the-science is constantly evolving. Two good examples of this are the elimination of the Delaney Clause (2) and the provision that establishes a system for periodic review of all pesticide registrations. The Delaney Clause is the old provision where raw and some processed foods were held to Disclaimer. The views presented in this paper are those of the authors and not necessarily those of the U.S. Environmental Protection Agency (EPA or the Agency).

104

U . S . government work. Published 1999 A m e r i c a n C h e m i c a l Society

In International Pesticide Product Registration Requirements; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1999.


105 different standards of safety. In drafting FQPA, Congress was able to abolish it (for pesticides) because our understanding of toxicity is a great deal better than it was in the 1950s, which is when the Clause was enacted. Much work and thought preceded the enactment of FQPA. Over the past several years, the scientific and public health communities have been raising concerns about the unique susceptibilities of infants and children to environmental toxins. In 1988, The U.S. Congress asked the National Academy of Sciences to evaluate the Agency's existing risk assessment practices to determine whether or not they adequately considered the unique potential for risks to infants and children. In 1993, the Academy published its report, Pesticides in the Diets of Infants and Children, concluding that infants and children may have significantly different exposures and/or responses to pesticides than adults (3). Because of these and other differences, the National Academy of Sciences recommended, among other things, that: "Because there exist specific periods of vulnerability during postnatal development, the committee recommends that an uncertainty factor up to the 10-fold factor traditionally used by EPA and FDA for fetal developmental toxicity should also be considered when there is evidence of postnatal developmental toxicity and when data from toxicity testing relative to children are incomplete in the absence of data to the contrary, there should be a presumption of greater toxicity to infants and children" (4). Eventually, this recommendation, among others, found its way into the provisions of FQPA. Major Provisions of FQPA EPA's Office of Pesticide Programs regulates pesticides under two statutes : FIFRA (The Federal Insecticide, Fungicide, and Rodenticide Act) and FFDCA (The Federal Food, Drug, and Cosmetic Act). Generally speaking, most of the regulatory aspects of the pesticide program are governed by the provisions of FIFRA while the human health risk assessment aspects fall under the scope of FFDCA. FIFRA requires that pesticides be 'registered' (licensed) by EPA before they are sold or distributed for use in the United States. FFDCA authorizes EPA to settolerances,or maximum legal limits, for pesticide residues in food. FQPA amended both of these statutes. On the FIFRA side, FQPA requires that the Office of Pesticide Programs, among other responsibilities: review its pesticide registrations periodically to ensure that they still meet the most up-to-date science; accelerate the registration process for 'safer,' reduced risk pesticides; and establish separate programs for minor uses and antimicrobials. Minor uses of pesticides are generally defined as uses for which pesticide product sales are low enough to make it difficult for a manufacturer (i.e., the registrant) to justify the costs of developing and maintaining EPA registrations. Collectively, such minor crops are very important to a healthy diet and include many fruits and vegetables. Antimicrobial pesticides are substances used to control harmful microorganisms including bacteria, viruses or fungi on inanimate objects and surfaces. Antimicrobial products have traditionally included disinfectants, sanitizers, sterilizers, antiseptics, and germicides. The most significant reforms brought about by FQPA (in terms of human health risk assessment) are on the FFDCA side and revolve around the broad changes to the tolerance setting procedures. FQPA establishes a single, health-based safety standard for



106 pesticide tolerances and provides special considerations for infants and children. Prior to FQPA, EPA operated under a dual safety standard where raw and some processed foods were regulated under different sections of FFDCA, each with its own standard of safety; this was the old Delaney Clause. The FQPA provisions revolving around the special considerations for children are dramatically impacting the way the pesticide program assesses risk. Specifically, FQPA directs the Agency to use an extra 10-fold safety factor to take into account potential pre- and postnatal developmental toxicity and completeness of the data with respect to exposure and toxicity to infants and children; a different safety factor may be used only if, on the basis of reliable data, such a factor will be safe for infants and children. Additionally, the new law directs EPA to consider available information on : aggregate exposure from all nonoccupational sources (i.e., oral exposure from food and drinking water and dermal and inhalation exposure from pesticides used in and around the home); the effects of cumulative exposure to the pesticide and other substances with common mechanisms of toxicity; the effects of in utero exposure; and the potential for endocrine disrupting effects. Incorporating these factors into the tolerance setting process poses a challenge, largely because the risk assessment methodologies and science policies for handling the additional 10-fold safety factor, aggregating exposure, and looking at common mechanisms of toxicity were not in place the day FQPA was signed, and the new law did not provide a phase-in period. Meeting the Challenge When FQPA was passed, EPA took an aggressive approach to implementation, with a strong emphasis on public and stakeholder involvement. The following standing committees, which all operate under the rules of the Federal Advisory Committee Act (5), are providing advice to EPA on FQPA matters: (1) The FIFRA Scientific Advisory Panel and the Agency's Science Advisory Board, external peer review groups made up of experts in key scientific and public health disciplines, advise EPA on major scientific issues; (2) The Pesticide Program Dialogue Committee, a broadly representative committee, provides advice and guidance to the Agency on regulatory development and reform initiatives as well as public policy and regulatory issues associated with evaluating and reducingrisksfrom pesticide use; and (3) The Endocrine Disrupters Screening and Testing Advisory Committee provides advice and counsel to the Agency on a strategy to screen and test endocrine disrupting chemicals and pesticides. In addition to this very direct public involvement, EPA has been consulting with other government agencies including the U.S. Department of Agriculture, the U.S. Department of Health and Human Services, and the U.S. Department of Justice on a range of issues relevant to improving food safety, as directed by the new law. Addressing the Scientific Provisions As stated previously, implementing the scientific provisions of FQPA presents quite a challenge to the Agency. In broad terms, the mandates of this new law require us to dramatically strengthen the way in which we conduct our risk assessments. As defined by the National Research Council, risk assessment can be thought of as four steps (6):



107 hazard identification; dose-response assessment; exposure assessment; and risk characterization. During the hazard identification stage, all available toxicology data are reviewed and the endpoints (i.e., what effects the pesticide will cause) are identified. Some common endpoints include carcinogenicity, mutagenicity, and general systemic toxicity. In dose-response assessment, a reference dose or RfD is determined for toxicological effects that are believed to occur via a 'threshold' model (i.e., the effect occurs once a certain dose is met). A reference dose is an estimate of the level of daily exposure to a pesticide residue, which, over a 70-year life span, is believed to have no significant deleterious effects. Other federal agencies, such as the Food and Drug Administration, refer to this as an acceptable daily intake or ADI. The pesticide program calculates a reference dose by dividing the no-observed-effect level from a chronic study by two uncertainty factors - a 10-fold factor to account for uncertainty in extrapolating from animals to humans (i.e., interspecies) and a 10-fold factor to account for the variation within the human population (i.e., intraspecies). Exposure assessment involves determining how much pesticide humans are exposed to by the three routes: oral, dermal, and inhalation. Finally, risk characterization is the process of combining the dose-response and exposure information to describe the overall magnitude of the public health impact. Risk characterization can be expressed quantitatively via a margin-of-exposure or MOE; it includes a discussion of the uncertainties inherent to the hazard and exposure assessments. The Additional Safety Factor. One of the more significant and interesting aspects of the new law is the additional 10-fold safety factor or 'FQPA Factor' provision. FQPA states: "In the case of threshold effects...an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children. Notwithstanding such requirement for an additional margin of safety, the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children" (7). Over the past year and a half, EPA has been striving to implement this provision of FQPA. Early on, FQPA Factor decisions were made at the dose-response assessment stage and were largely driven by the completeness of the toxicological database and whether or not children appeared to be or were more likely to be more sensitive to the pesticide under question. Now, as the pesticide program has given this provision more thought and other parts of the Agency and the federal government have taken an interest in this issue, the Agency is considering moving the FQPA decision point from dose-response to risk characterization. In the same discussions, EPA is also trying to establish criteria for more widely applying the FQPA Factor - that is, applying the factor based on the entire toxicity profile and exposure scenarios, using a weight-of-the-evidence approach, and not just on the basis of increased susceptibility.



108 Aggregate Exposure. Another significant provision of FQPA is the requirement for 'aggregate' exposure. Under the law, "In establishing...a tolerance...for a pesticide chemical residue, the Administrator shall consider.. .available information concerning the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational sources" (8). The Agency has interpreted this provision to mean that exposures for tolerance assessments must be aggregated across all routes - oral (from food and drinking water); dermal (from residential exposure); and inhalation (from residential exposure). Prior to FQPA, in assessing exposures for tolerances, the pesticide program only considered the oral route, and generally only food, but not drinking water. The pesticide program is faced with two challenges in implementing the aggregate exposure provision: (1) determining pesticide residues in drinking water; and (2) adequately estimating pesticide residues that occur as a result of residential exposure. Drinking water residues are difficult to discern because the Agency typically does not require these types of data. Although available from various sources (U.S. Geological Survey, states, and academia) monitoring data for pesticide residues in ground and surface water are extremely limited and often provide information on ambient water quality only and not drinking water quality, per se. Because of this lack of actual pesticide monitoring data for drinking water and the limited nature of ambient water quality data for pesticides, the Agency currently uses simulation models, which utilize conservative assumptions (health-protective), as screening tools to estimate pesticide residues in ground and surface water. To address the problem of estimating pesticide residues in drinking water, EPA has been working with the International Life Sciences Institute, a nonprofit, worldwide foundation established in 1978 to advance the understanding of scientific issues related to nutrition, food safety, toxicology, and the environment. A Workshop has been organized that will include participation from scientists with expertise in fate, transport, and occurrence of pesticides in ground and surface water. The working group will be asked to identify and critique currently available methods to estimate concentrations of pesticides in ground and surface waters using models and monitoring data. Calculating reasonable residential exposure is problematic because again, these data are not routinely required and the pesticide program's current methods for estimating residential exposure tend to greatly overestimate the actual exposure. To secure better residential exposure data, the Office of Pesticide Programs is working with industry in the development of indoor and outdoor residential exposure data. Currently, the Outdoor Residential Exposure Task Force is developing exposure data for professional and nonprofessionals (i.e., homeowners) who use pesticides on turf or lawns and for exposure incurred while coming into contact with a lawn that has been treated. Additionally, industry is now considering a similar effort to generate indoor residential exposure data. Common Mechanism. A third important scientific consideration stemming from FQPA is the 'common mechanism' provision. According to FQPA, "In establishing...a


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tolerance...for a pesticide chemical residue, the Administrator shall consider...available information concerning the cumulative effects o f such residues and other substances that have a common mechanism o f toxicity" (9). The classic group o f pesticides that are believed to act v i a a common mechanism o f toxicity are the organophosphates. A s with the drinking water issue, E P A has enlisted the assistance o f the International L i f e Sciences Institute to define what is a common mechanism and then to figure out how to add up' the cumulative effects. Downloaded by UNIV MASSACHUSETTS AMHERST on September 26, 2012 | http://pubs.acs.org Publication Date: June 16, 1999 | doi: 10.1021/bk-1999-0724.ch013

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Endocrine Disruptors. The final major F Q P A scientific provision relates to endocrine disruptors, where the Agency is required to develop a screening and testing program to determine whether certain substances (including all pesticides) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect..." (10). So far, E P A has: (1) Formed the Endocrine Disruptors Screening and Testing Advisory Committee to provide recommendations on a strategy for selecting and setting priorities for screening and testing; on identifying new/existing screening tests for validation; on the use o f available screens; and on how to determine the need to test beyond the initial screens; (2) Established a national research strategy and a $10 million research program through the Agency's Office o f Research and Development; and (3) Established international cooperation through the Organization for Economic and Cooperative Development and other international organizations to increase research and develop harmonized approaches to endocrine disruption issues. Conclusion The advent o f F Q P A has presented the Agency with some challenging and fascinating issues to tackle. In response to this challenge, E P A has enlisted the talents o f industry, academia, environmental groups, etc., as well as our own professional staff and staff o f other government agencies, to devise new and creative methodologies for fully implementing the provisions o f this new law. In the years to come, we hope to continually guarantee the children o f the United States a safe and healthful food supply.

Literature Cited

(1) Food Quality Protection Act of 1996, Public Law 104-170, August 3, 1996. (2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 306b(d)(1)(H), 348(c)(3)(A), 376(b)(5)(B), 1994. (3) National Research Council. Pesticides in the Diets of Infants andChildren;National Academy: Washington, DC, 1993; p 359. (4) National Research Council. Pesticides in the Diets ofInfants and Children; Nationa Academy: Washington, DC, 1993; p 9. (5) Federal Advisory Committee Act, 5 U.S.C. App. 2. (6) National Research Council. Risk Assessment in the Federal Government: Mana the Process; National Academy: Washington, DC, 1983; p 38. (7) FederalFood,Drug, and Cosmetic Act, § 408(b)(2)(C)(ii), 1996. (8) Federal Food, Drug, and Cosmetic Act, § 408(b)(2)(D)(vi), 1996. (9) Federal Food, Drug, and Cosmetic Act, § 408(b)(2)(D)(v), 1996. (10) Federal Food, Drug, and Cosmetic Act, § 408(p)(1), 1996. In International Pesticide Product Registration Requirements; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1999.

Implementation of the Food Quality Protection Act ... - ACS Publications

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