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RS20043: Pesticide Residue Regulation: Analysis of Food Quality Protection Act Implementation
August 3, 1999
The Food Quality Protection Act of 1996 (FQPA) amended the Federal Insecticide, Fungicide, and Rodenticide Act, governing U.S. registration, sale, and use of pesticide products, and the Federal Food, Drug, and Cosmetic Act, under which the Environmental Protection Agency (EPA) sets allowable pesticide residue levels for food (tolerances). The FQPA directs EPA to ensure a "reasonable certainty of no harm" due to pesticide exposure and requires reevaluation of 33% of existing tolerances against this new safety standard by August 1999, 66% by August 2002, and 100% by August 2006. The Act directs EPA to evaluate aggregate risks of pesticides through all routes of exposure and cumulative risks of different pesticides when they have similar toxic effects. EPA must modiiy or revoke tolerances that are not safe, and modily registrations (labels) for the associated pesticides. EPA reported that one-third of tolerances were reassessed prior to August 1999, but many posed little or no risk to human health. Dissatisfaction with Agency reassessments caused consumer groups to withdraw from stakeholder groups with which EPA consulted in developing implementation policies. Pesticide producers and users remain engaged in policy development. The on-going test case for FQPA implementation is the reevaluation of risks for organophosphate insecticides, used on many popular fruits, vegetables, and grains. EPA has determined that at least two of them pose unacceptable risks to children. As a result, registrations for all fruit uses of methyl parathion will be canceled before the next growing season. EPA claims to be meeting FQPA obligations, but interest groups have filed lawsuits challenging the process and the pace of EPA action.Introduction
The 104th Congress enacted significant changes to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), goveming U.S. registration, sale, and use of pesticide products, and the Federal Food, Drug, and Cosmetic Act (FFDCA), under which the U.S. Environmental Protection Agency (EPA) sets allowable pesticide residue levels in food and animal feed (tolerances). The vehicle of these changes was the "Food Quality Protection Act of 1996" (FQPA; Public Law 104-170), which established a new standard of food safety: a "reasonable certainty of no harm" due to any legally permissible pesticide residue on food, while recognizing the benefits of pesticide use on food crops.
In the three years since FQPA was enacted, EPA implementation of the new safety standard has been carefully observed and often criticized, sometimes for conflicting reasons, by farmers, chemical manufacturers, environmentalists, other stakeholders, and the Administration. This report evaluates the status of FQPA implementation and related issues, particularly potential effects on regulation of certain popular pesticides used in food production and processing. For a detailed summary of the FQPA, including provisions unrelated to food safety, see CR5 Report 96-759 ENR,Pesticide Legislation: The Food Quality Protection Act of 1996 (Public Law 104-170).
Food Quality Protection Act MandatesA key expressed purpose of the FQPA was to coordinate pesticide registration under FIFRA with tolerances set under the FFDCA to ensure that any pesticide allowed to be used on food would leave only a "safe" residue. Section 408(b)(2)(A)(ii) of the FFDCA, as amended, defines "safe" to mean that --
To ensure the safety of tolerances established prior to August 1996 for pesticide residues in or on food or animal feed, the FQPA directs EPA to reevaluate them against the new safety standard. The Act requires reevaluation of 33% of existing residue limits for food-use pesticides by August 3, 1999, 66% by August 3, 2002, and 100% by August 3, 2006. The FQPA directed EPA to reevaluate tolerances for the riskiest pesticides first.
If EPA finds that residues of a pesticide used on food may pose a risk greater than allowed under the FQPA, the Act requires a change in the FFDCA tolerance level as well as in the FIFRA registration (that is, product labels) to restrict the number or manner of approved pesticide uses, and so to reduce human exposure to a "safe" level. In assessing the risk of pesticide residues allowed by a tolerance, the FQPA requires EPA to consider:
in utero exposure;
· aggregate risk from all sources and through all routes of exposure; and
· cumulative risks due to exposure to the pesticide and to other pesticides that may have similar toxic effects (i.e., a "common mechanism of toxicity").
EPA asserts that it is on schedule to achieve statutory milestones for food-use pesticide regulations. By August 3, 1999, EPA reevaluated and, when necessary, modified, more than 33% of tolerances for pesticide residue levels in food to ensure the safety of children and other consumers. EPA has worked with stakeholders to implement the new law. Pesticide producers and users want to secure assurances that the risks of popular organophosphates (used widely on fruits, vegetables, and grains) and other pesticides will be evaluated by EPA based on real data rather than worst-case assumptions. At the same time, public health, environmental, and consumer groups want prompt regulation of pesticides that in their view are not safe.Progress toward Milestones. On the date of FQPA enactment, there were 9,728 residue tolerance levels and exemptions in effect for active and inert pesticide ingredients. EPA divided these into groups, based largely on relative risk to public health, and published a schedule for reevaluation of tolerances in the Federal Register on August 4, 1997. The first group of pesticides subject to tolerance reassessment includes:
· Pesticides subject to reregistration requirements and for which EPA would be issuing Reregistration Eligibility Decisions after FQPA enactment2; and
· Pesticides whose tolerances and exemptions are in the process of being revoked.
An itemized list of these pesticides appears in theFederal Register notice announcing the schedule and requesting public comments.3 EPA completed reevaluation of more than 3,000 tolerances before the August deadline. EPA concluded that relatively few of these tolerances posed significant risks to human health: many were for crop uses that were not current, i.e., for residues on crops not treated with the pesticide in question. Consequently, on August 3, 1999, the Natural Resources Defense Council (NRDC) announced that it would file a lawsuit in the U.S. District Court for the Northem District of Califomia accusing EPA of failing to satisfy the FQPA requirement to review first the tolerances for higher-risk chemicals.
Stakeholder Involvement. According to EPA, pesticide regulations directly affect approximately 30 major pesticide producers, 100 smaller producers, 2,500 formulators, 29,000 distributors and retailers, 40,000 commercial pest control firms, 1 million farms, 3.5 million farm workers, several million industry and government users, and all households.4 Within each of these groups there are distinct subgroups with different views on the federal role in pesticide regulation. Some politically active stakeholder groups include multinational pesticide producers (e.g., Monsanto), specialty chemical manufacturers, agribusinesses, organic farmers, dairy farmers, fruit and nut growers, landscape gardeners, environmentalists, public health advocates, and consumer groups.
A handful of contentious issues has potentially far-reaching impacts on the availability of pesticides for particular uses, the cost of food and other consumer products, and intemational competitiveness of U.S. agricultural products. These issues are summarized below. EPA is seeking to resolve them through cooperative decisions involving the major stakeholders.
EPA has been working with several committees since passage of the law to ensure an open decision-making process. A Food Safety Advisory Committee (FSAC), consisting of growers, pesticide companies, environmental groups, and state officials, was established immediately after FQPA passage, and it developed interim decision policies, which still are being employed. This committee finished its work in December 1996. A permanent, broadly representative advisory committee, the Pesticide Program Dialogue Committee, has had on-going discussions about FQPA implementation. EPA also has involved its FIFRA Science Advisory Panel of independent scientists in developing approaches for implementing several of the more technically challenging FQPA provisions. Another standing committee advising EPA is the State FIFRA Research and Evaluation Group. Several task forces and ad hoc working groups have worked on very specific issues. For example, EPA created a task force to identify data and methods needed to apply the 10-times safety factor to protect the health of children.
Despite these consultative efforts, growers and chemical manufacturers continued to express concerns, and Vice President Gore sent a memorandum April 8, 1998 to EPA directing the Agency to work more closely with the U.S. Department of Agriculture and with stakeholders in implementing the FQPA. In response, EPA established a new advisory group and committed itself to apply sound science, employ an open process of decision making, and ease any necessary transition to new rules so as not to jeopardize agriculture and farm communities. The Tolerance Reassessment Advisory Committee (TRAC) was established jointly by EPA and the U.S. Department of Agriculture (USDA) on April 30, 1998, as a subcommittee of EPA's National Advisory Council for Environmental Policy and Technology. During the first year of its existence, the 45 committee members represented environmental and public interest groups; pesticide industry and trade associations; users, growers, and commodity organizations; pediatric and public health organizations; federal agencies, tribal, state, and local governments; academia; and consumer groups. However, the Environmental Working Group, a consumer advocacy group, resigned from TRAC in October 1998, claiming that the Clinton Administration had failed to take action to protect children from pesticide risks. The remaining environmental, consumer, and public health advocacy groups resigned in late April 1999 citing the slow pace of EPA action to reassess tolerances of concern.
Implementation Issues. TRAC has identified nine science policy issue areas affecting implementation of the FQPA with regard to tolerances:
· Exposure assessment (how to interpret a result of "no detectable residue");
· Dietary exposure estimates (need for better data);
· Dietary (drinking water) exposure estimates;
· Assessing residential exposure;
· Aggregating exposures from all non-occupational sources;
· Cumulative risk assessments for pesticides with a common mechanism of toxicity (e.g., organophosphates); and
· Appropriate toxicity endpoints for risk assessments of organophosphates.
EPA is developing policy guidance documents on each of these issues.6 Draft policies are being published in the Federal Register and public comments are being sought. EPA will evaluate the policies alter considering public comments. Pesticide industry and agricultural organizations would like EPA to use a notice-and-comment rulemaking process to establish science policies, but EPA has resisted that approach fearing loss of flexibility and delays. Eighteen organizations filed a complaint June 7, 1999 challenging EPA's consultative process (American Farm Bureau Federation v. U.S. Environmental Protection Agency, No. 99-CV-1405 (D.D.C. filed June 7, 1999)).
A particularly contentious implementation issue revolves around the FQPA directives to use "available data" and "reliable data" as well as the FQPA mandate to order testing if EPA determines that data are "reasonably required to support the continuation of a tolerance or exemption that is in effect . . . for a pesticide chemical residue on a food," [FFDCA, Section 408(D(1)]. Stakeholders disagree about what is an appropriate course of action for EPA when there is insufficient "reliable" data to estimate risk. Pesticide producers ideally would like EPA to delay estimating risk until reliable data can be collected; public health advocates would like EPA to estimate risk based on "available" data and, if risk is found unacceptable, to reduce the potential for human exposure through regulations. A suggested compromise alternative is for EPA to set a time-limited temporary tolerance for pesticide residues on certain crops (a procedure allowed by FQPA and in current use for emergency exemptions).
Members of the pesticide industry also want EPA to "call in" data, particularly on exposure levels; EPA failure to issue a data call in was another issue raised by the lawsuit filed June 7 (see above). Although pesticide producers conduct toxicity testing, and they need not wait for an EPA order to produce data, such an order provides certain legal and financial protections. Recently, EPA announced plans to call in data on neurotoxicity and pesticide residues.Food Tolerances for Organaphasphate Pesticide Residues
Organic phosphates, or organophosphates, are complex synthetic compounds. Two well-known organophosphates are methyl parathion and malathion. In agriculture, organophosphates are used as broadly effective insecticides, for example, to kill boll weevils, spider mites, fruit flies, or aphids. Various organophosphates are used on fruit trees, vegetables, ornamental plants, cotton, corn, soybeans, rice, and wheat.
EPA has determined that organophosphates are among the pesticides posing the greatest risks to human health and the environment, and therefore the Agency began to evaluate the safety of these products during the first 3-year period following enactment of the FQPA in 1996. Organophosphates have a highly variable, toxic effect on the nervous systems of people and other animals. Some are acutely toxic, others much less so; but, because they share a common mechanism for exerting this effect, they are the first pesticides that will be considered as a group.7 There are 1,800 tolerances established for various organophosphate pesticide residues on crops.
Growers and pesticide manufacturers are concerned about the impact of FQPA implementation on these widely used pesticides. Although rumors that EPA might cancel registrations for the entire class of organophosphates appear alarmist, concern about the fiuure availability of some of these pesticides for some uses is justified, because evidence suggests that cumulative risk probably is greater than allowed under the new law. EPA's preliminary risk assessments for 28 organophosphates indicated that the risks of some individual organophosphates (e.g., methyl parathion) exceeded acceptable levels, even if non-food sources of exposure to the pesticide were not considered. However, most of the preliminary risk assessments relied on numerous assumptions about exposure, because data were either not available or unreliable. As more data are collected, assessments might narrow the range of probable exposures and risks to levels that are reasonably certain to be safe, as farm groups and pesticide producers contend. On the other hand, data might support conclusions of the Environmental Working Group, a consumer safety advocacy group, which claims that children are exposed to unsafe levels of organophosphates on pears, apples, grapes, and peaches, and that the exposure can damage developing brains and nervous systems. In the case of methyl parathion, EPA determined that the risks to children were unacceptable. Registrations for all fruit uses and many other food and non-food uses will be canceled before the next growing season.Conclusion
When Congress passed the FQPA by unanimous votes in both Chambers, many hailed it as one of two "risk-based" laws enacted in 1996 (the other being the Safe Drinking Water Act Amendments). It established a new standard for food safety that recognized the benefits of pesticide use on food crops, but also guaranteed there would be a reasonable certainty of no harm from pesticide residues. Three years after enactment, EPA claims to be meeting statutory deadlines. However, lawsuits filed in June and August 1999 question the process and pace of EPA implementation activities.
1 A reference dose (RfD) is an estimate of a safe daily exposure level that is likely to be safe over a lifetime.
2 EPA has a deadline of 2002 for completing the reregistration of pesticides registered prior to 1984. Amendments to HFRA in 1972 directed EPA to "reregister" approximately 35,000 older products, thereby assessing their safety in light of current standards.
3 62 Federal Register 42019, Aug. 4, 1997
4 EPA, Office of Prevention, Pesticides, and Toxic Substances. 1996 Food Quality Protection Act Implementation Plan. Mar.1997. p.4.
5 For the most part, the arguments surrounding these issues are technical. The impact of decisions may be substantial. For example, EPA currently uses a 99.9th percentile to generate risk estimates. According to a summary of a March 1998 meeting of the FIFRA Scientific Advisory Panel, "The Panel differed on whether setting criteria at the 99.9th percentile is a conservative approach. However, if the 99.9th percentile is utilized, a percentage of the population (e.g., 23,000 children) will still be exposed to acute effects" (http://www.epa.gov/pesticides/SAP ) . Critics want EPA to use a 95th percentile which would leave a greater percentage of the populafion exposed to potential acute effects but would allow the pesticide to be used more.
6 63 Federal Register 58038, Oct. 29, 19987 Organophosphates inhibit cholinesterase, an enzyme necessary for the proper functioning of the nervous system.
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