CRS Report: 96-759 - Pesticide Legislation: Food Quality Protection Act of 1996 (P.L. 104-170)

Linda Jo Schierow
Specialist in Environmental Policy
Environment and natural Resources Policy Division

The 104th congress enacted significant changes to the Federal Insecticide, fungicide, and Rodenticide Act (FIFRA), governing U.S. sale and use of pesticide products, and the Federal Food, Drug, and Cosmetic Act (FFDCA), which limits pesticide residues on food. The vehicle of these changes was H.R. 1627, the "Food Quality Protection Act of 1996" (FQPA), enacted August 3, 1996, as Public Law 104-170. Under FIFRA, the new law will facilitate registrations and reregistrations of pesticides for special (so-called"minor") uses and authorize collection of maintenance fees of support pesticide reregistration. Food safety provisions will establish a single standard of safety for pesticide residue on raw and processed foods; provide information through large food retail stores to consumers about the health risks of pesticide residues and how to avoid them; preempt state and local food safety laws if they are based on concentrations of pesticide residues below recently established federal residue limits(called"tolerances"); and ensure that tolerances protect the health of infants and children.

Contrary to widespread reports, the FQPA does not repeal the Delaney Clause or amend FFDCA section 409: food additives that are not pesticide residues remain subject to the "zero-risk" Delaney standard. Rather, Public Law 104-170 eliminated the distinction between raw and processed food tolerances so that all pesticide residues will be regulated under and amended FFECA Section 408. New Section 408 requires all tolerances to be "safe," ensuring a "reasonable certainty of no harm" from pesticides. It authorizes slightly higher residue concentrations on foods when pesticide use avoids greater health risks to consumers or significant disruptions to domestic production of an adequate, wholesome, and economical food supply.

The FQPA, as enacted, does not address two issues that were addressed by H.R. 1627, as introduced and reported in the House, but were deleted before the House and Senate debates. The FQPA does not include a proposal to federally preempt local pesticide use regulations which was opposed by several states with laws either authorizing or preempting local regulation. the FQPA also omits a provision opposed by Indian tribes and the Administration that would have prohibited tribal enforcement of pesticide use laws on land within tribal boundaries if less than half that land were owned by the tribe or tribal members.

The FQPA has widespread support in the community of growers, food processors, chemical suppliers, environmental and consumer advocacy groups, and state government agriculture officials. The Clinton Administration also generally supports its provisions.

For readers not familiar with the statutes, Appendix A describes key FIFRA and FFDCA authorities and provisions. Appendix B provides a brief section-by-section summary of Public Law 104-170.

The 104th Congress enacted significant changes to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), governing the U.S. sale and use of pesticide products, and to the Federal Food, Drug, and Cosmetic Act (FFDCA), which limits pesticide residues on food in interstate commerce. The vehicle of these changes was H.R. 1627, the "Food Quality Protection Act of 1996" (FQPA), enacted August 3, 1996 as Public Law 104-170. This report summarizes and analyzes provisions of the new law. It also describes key provisions in the bill as reported in the House that were omitted prior to debate on the House floor and markup in the Senate.1 For more information on these provisions, see CRS Report 96-495 Pesticide Legislation: Food Quality Protection Act of 1995 (H. R. 1627 and S. 1166) which summarizes and compares provisions of H.R. 1627, as reported by the House Committee on Agriculture (prior to markup by the House Commerce Committee), with provisions of S. 1166, as introduced in the Senate.

In general, key FIFRA issues revolved around: the roles of state, local, and tribal governments in pesticide regulation and federal law enforcement; the cost of scientific tests required by the U.S. Environmental Protection Agency (EPA) to support pesticide registration and reregistration, and delays in processing applications for new or amended registrations, especially for minor uses; and long delays in reregistration of older pesticides and the need for fees to support the effort. A lesser issue involved state authority to require training of persons who regularly apply non-restricted pesticides in urban and suburban areas.

In this context, congressional concerns about FFDCA centered on the so-called "zero-risk" standard of Section 409 (the Delaney Clause) for concentrated residues in processed foods of pesticides that produce cancer in experimental animals. There also were generally recognized needs for better data on risks to infants and children from pesticide residues on food; coordination of tolerance revocations with pesticide food-use cancellation; and increased monitoring of food imports for pesticide residues. Other issues included a proposal for federal preemption of state and local authority to impose requirements on food with pesticide residues that are not unsafe based on federal law and EPA adoption of international residue standards.

All of these issues were addressed in H.R. 1627, as introduced; provisions related to pesticide use were approved, amended, in May 1995 by a subcommittee of the House Agriculture Committee. The full Committee further amended and reported the bill in July II, 1996. Food safety provisions were referred to the House Commerce Committee, which reported July 23, 1996 (H.Rept. 104-669, Parts I and II). The bill was further amended after being reported in the House but prior to House debate and passage July 23, 1996. The Senate Committee on Agriculture, Nutrition, and Forestry incorporated House-passed language as a substitute for the provisions of S. 1166, and the Senate passed H.R. 1627 the same night, July 24, 1996. The FQPA was amended after it was reported but before it was debated and passed in the House and referred to the Senate. This amended FQPA omitted provisions that were controversial in the House-reported bill that would have preempted local pesticide use ordinances and prohibited tribal enforcement of pesticide use laws within reservation boundaries.

In the following text, analysis of provisions related to pesticide uses, including amendments to FIFRA, precedes analysis of food safety provisions and FFDCA amendments. Within this framework, issues are considered roughly in the order they are treated in the FQPA.

Canceling a pesticide registration, when it is found to cause "unreasonable adverse effects," can be a prolonged process, lasting 4 to 8 years or more. To prevent an "imminent hazard" during this period, EPA can suspend registration
-- meaning that use of the pesticide is immediately prohibited -- but not before EPA has published, or provided the registrant with, a notice of its intention to cancel the registration. Before the FQPA, FIFRA allowed EPA in an emergency to issue a suspension order at the same time it proposed to cancel or change a registration, and the suspension could become final after 30 days. However, the Clinton Administration wanted to allow suspensions in cases of "imminent hazard" before any cancellation action. Others, such as the National Association of State Departments of Agriculture (NASDA), which represents the 54 leading public officials for agricultural policy in each state and territory, found the existing authority adequate.

Public Law 104-170 allows EPA to issue a suspension order in an emergency, before issuing a notice that it intends to cancel a registration or to change a classification of the pesticide, but the suspension order will expire after 90 days if EPA does not provide notice by that time.

While not a particularly large proportion of total pesticide use by volume, household and business uses of pesticides in urban and suburban settings may lead to exposure of larger and more diverse populations than in agricultural applications. Concerns about such exposures include immediate toxic reactions in sensitive individuals, as well as less visible but longer-term health effects such as cancer. Pesticides that end up in rivers, lakes, and groundwater are considered a significant water pollution problem. This can result from excessive and improper application or improper disposal of pesticide containers, for example. While these concerns apply to agricultural applications as well, urban/suburban uses are sometimes at higher concentrations and may be applied by persons unfamiliar with risks or proper application practices. Moreover, when pesticides are applied to lawns and gardens, golf courses, roadsides, public buildings, apartment buildings, and single-family homes, the people exposed may be very young or elderly and in robust or fragile health. People may be exposed to pesticides in such settings unknowingly or at least without prior warning, as for example, when entering a recently treated roadside area or public building.

Concerns about routine applications of pesticides in urban and suburban areas have led to calls for training of "maintenance applicators" of unrestricted pesticides, such as janitors, general maintenance personnel, sanitation personnel, and grounds maintenance personnel. (Applicators of restricted pesticides already must be trained.) The FQPA, Title I, Subtitle B adds a new section to FIFRA authorizing, but not requiring, states to establish minimum requirements for training of maintenance pesticide applicators and any individual who uses or supervises the use of pesticides not classified for restricted use for the purpose of providing structural pest control or lawn pest control on the property of another for a fee. Any training provided must include instruction in the safe and effective handling and use of pesticides in accordance with EPA-approved labels and in integrated pest management techniques. Requirements do not apply to government employees, individuals who use antimicrobial pesticides, private (e.g., household) use of pesticides, or any use of ready-to-use consumer products. The bill authorizes EPA only to inform states about the provisions of this subtitle.

According to experts, about 1000 pesticide use registrations important to the agricultural community for low-acreage, specialty crops (so-called "minor" agricultural uses) may be canceled rather that reregistered.2 Another 2,600 new minor-use registrations would be submitted through FY1997 to meet new pest control needs or to replace disappearing minor-use registrations.3 Without such registrations, production of many fruit, nut, and vegetable crops might be more costly, result in lower quality, and diminish availability to consumers. Any loss in productivity could have a detrimental economic impact on agricultural interests, and possibly an adverse impact on consumer nutrition. About $35 billion in fruit, vegetable, and other specialty crops are produced annually in the United States (20% of total farm receipts, 42% of total crop receipts). Some farmers also believe the loss of minor-use pesticide products will put them at a competitive disadvantage with foreign producers who would continue to have access to the pesticides.

Although producers sometimes may cancel a registration because they fear complete safety testing will reveal an unreasonable risk from the pesticide use, the more common obstacle to maintaining the availability of pesticides for minor uses is economic: for some pesticides the markets are not large enough to economically justify the testing costs of maintaining minor-use registrations. These problems persist despite amendments to FIFRA in the 1990 farm bill (Public Law 101-624) which: eliminated a requirement for field residue data --the data most often lacking for minor food uses -- for minor use pesticides in geographic areas where the pesticide would not be registered for use; authorized EPA to reduce or waive the fee for a minor use pesticide registration; required public notice of voluntary registration cancellations and established a grace period to transfer registrations for minor use pesticides to new registrants; and authorized research that emphasized minor or local pests.

EPA would like to expedite procedures for registering minor-use pesticides. The Agency claims that it is now doing as much as possible administratively under FIFRA to expedite the process of minor-use approval. Concerned growers have organized the Minor Crop Farmers Alliance to seek legislative remedies. One of their goals is to increase federal funding through such programs as the USDA interregional project (IR-4) for data collection in support of minor-use registration.

The FQPA, Title II, Subtitle A, addresses minor uses of pesticides. All interest groups as well as EPA backed these provisions. In support of minor-use registrations and reregistrations, the FQPA will:

The FQPA also extends the period of exclusive use -- that is, the years during which no one but the original registrant may use the safety data -- for registrants of minor uses. This will provide more time for the registrant to recover costs and make a profit. The current 10-year period of exclusive use is expanded one additional year for each 3 minor uses registered within 7 years of the first use registration. No exclusive use period can be longer than 13 years. Data supporting a new minor use registered after the original exclusive use period has lapsed is protected for 10 years, as long as the data are not used to support a registration for a non-minor use and the minor use registration remains in effect.

The FQPA requires EPA to report within 3 years of enactment on its progress in registering minor uses.

A second category of minor-use pesticides are the "antimicrobial pesticides" used, for example, as preservatives in paint, antifoulants in industrial cooling water, disinfectants, and sanitizers. The FQPA, Title II, Subtitle B sets time limits for registration of such pesticides and directs EPA to identify and evaluate reforms to the registration process to reduce review periods to the maximum extent practicable. Maximum time periods for review are specified in Subtitle B for various activities. EPA believes that these provisions might divert scarce EPA resources from more important tasks.

Some pesticides used to protect public health from diseases carried by insects or other animals are considered minor-use pesticides. The FQPA, Title II, Subtitle C extends some of the provisions for agricultural minor uses to "public health pesticides," but also increases the involvement of the DHHS Secretary in decisions about pesticide registration.4 It also directs EPA to identify pests of significant public health importance and to analyze and compare public health benefits of pesticide use against the risks. This subtitle authorizes appropriations up to $12 million for FY1997 and "such sums as may be necessary thereafter to implement FIFRA Section 4.5 EPA supported these provisions.

Title II, Subtitle D of the FQPA establishes an expedited review process for applications to register or amend registrations for pesticides that are expected to reduce overall pesticide risks. EPA also supported this subtitle.

Title III defines "integrated pest management" and directs USDA and EPA to cooperate in establishing a research, demonstration, and education program to support adoption of IPM techniques. In addition, federal agencies would be directed to use and promote IPM. This provision was not controversial.

EPA has a long-standing policy of coordinating implementation of all statutory provisions governing pesticides for food uses, which the agency recently reaffirmed (61 Federal Register 2378, Jan.25, 1996). Based on this coordination policy, EPA revoked FFDCA Section 408 tolerances for raw agricultural commodities if it revoked the corresponding FFDCA Section 409 food additive tolerances for residues in processed foods. Public Law 104-170 eliminates the distinction between raw and processed food tolerances and the need to coordinate two sets of tolerances, because FFDCA now regulates all pesticide residues under an amended FFDCA Section 408.

To ensure that pesticide registrations are based on current scientific and legal standards, FIFRA requires EPA to reregister all pesticides registered for use prior to 1984. Prior to enactment of P.L. 104-170, FFDCA did not have a similar requirement for revisiting pesticide residue tolerances. EPA partly addressed concerns about tolerances for older pesticides through its coordination policy: EPA revoked FFDCA pesticide residue tolerances after it canceled the corresponding FIFRA pesticide registrations for food uses if (and vice versa). However, EPA took 6 years on average, far longer than necessary, according to a December 1994 GAO report, to revoke tolerances after food-use pesticide registrations were canceled.6 Delays in completing the reregistration process were further cause for concern about the adequacy of older tolerances to protect human health.

Public Law 104-170 mandates FIFRA-FFDCA coordination as well as periodic review of tolerances for pesticide residues. All tolerances and exemptions in effect when P.L. 104-170 was enacted must be reviewed within 10 years. The law also requires EPA to reevaluate FFDCA tolerances and exemptions when reregistering older pesticides for uses on food and animal feed. It requires EPA to revoke or suspend tolerances for pesticides if the relevant food-use registration is canceled or suspended under FIFRA. Revocation of a tolerance will become effective within 180 days of the date on which the pesticide use becomes unlawful, unless residue of the pesticide will unavoidably persist. The reverse situation also is covered: by amending the FIFRA definition of "unreasonable adverse effects on the environment" to include human dietary risk from pesticide residue that violates a tolerance, it will prevent EPA from registering a pesticide (or will require cancellation of an existing registration) for a food use if a tolerance cannot be established (or is revoked) for that pesticide on that food. The FQPA also requires EPA to establish tolerances for residues that are expected to result from pesticide applications to foods allowed because EPA has granted an emergency exemption from FIFRA registration requirements under FIFRA Section 18.

1 Other legislative proposals to amend FIFRA are discussed in ORS Issue Brief 95016, Pesticide Policy Issues in the 104th Congress. CRS issue briefs are updated regularly to facilitate legislative tracking.

2 Pesticides: Minor Uses/Major Issues. Council for Agricultural Science and Technology. Ames, Iowa, 1992. p.3, 5.

5 Based on the heading for subsection (m), "Authorization of Funds To Develop Public Health Data," this $12 million is intended to develop data to support registration of public health pesticides, but the sentence authorizing appropriations states that it is "to carry out the purposes of this section" [emphasis added].

6 U.S. GAO. Pesticides: Reducing Exposure to Residues of Canceled Pesticides, GAO/RCED-95-23. Gaithersburg, MD.

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