Pesticide legislation:Food Quality Protection Act of 1996
(P.L. 104-170) III 96-759 ENR

96-759 ENR

CONTENTS FOR THIS SECTION

Enforcement of Tolerances: Imports
Harmonizing U.S. Tolerances with International Standards ...

Issues Considered and Dropped Prior to Passage

Preempting State, Tribal, and Local Pesticide Use Laws
Clarifying and Limiting Tribal Pesticide Enforcement

Conclusion
Congressional Hearings
Appendix A. Authorities and General Provisions of Pesticide Laws, as Amended by the FQPA

FIFRA Authority and General Provisions
FFDCA Authority and General Provisions

Enforcement of Tolerances: Imports

The United States imports approximately 15% of total domestic consumption of agricultural products, according to EPA, and pesticides are used in producing and storing many of these imports. The FFDCA prohibits importation of food with a pesticide residue that exceeds its tolerance. According to GAO, in 1994 FDA tested about 1% of all imported shipments for pesticide residue levels.22

Critics such as NASDA, contended that this monitoring rate was too low, making it unlikely that illegal pesticide residues would be detected on imported foods. FDA argued in the past that the low sampling rate understated the effectiveness of its detection program, because the agency concentrated its efforts on the foods and countries likely to be the source of residues and also on shippers with a history of violations. Such a strategy was intended to identify violations more successfully than a more frequent but random sampling. However, FDA officials said that inadequate resources were the primary reason that the agency had not tested a larger percentage of imported foods, according to GAO.23

Some questioned the cost and effectiveness of greatly increased FDA monitoring, arguing that it would be better to prevent problems from happening than to try to remedy them after the fact. They preferred developing bilateral agreements with trading partners to achieve equivalent, but not necessarily identical, inspection systems that could prevent contaminated products from arriving at U.S. ports of entry. The Clinton Administration favored increasing support for FDA monitoring of imported foods. The Administration also wanted enhanced authority to penalize those who introduced into interstate commerce foods with residues above FFDCA tolerances.

The FQPA authorizes an additional $12 million spread over FY1997, FY1998, and FY1999 for increased FDA monitoring of pesticide residues on imported and domestic foods. It also authorizes civil money penalties in lieu of penalties assessed under FFDCA criminal authorities, seizure authorities, or injunction authorities for persons who introduce adulterated food into interstate commerce, but not for growers. Such penalties may not exceed $50,000 for individuals and $250,000 for other persons, and may not exceed $500,000 for all such violations adjudicated in a single proceeding. See CRS Report 93-821 The Safety of Imported Food for more information about this issue.

Harmonizing U.S. Tolerances with International Standards

The United States and its trading partners are concerned about facilitating trade as well as ensuring the safety of food imports. Because diverse health and safety standards can be barriers to international trade, the 104th Congress considered whether to require EPA to "harmonize" tolerances with international pesticide residue limits. Because diverse standards may be justified based on regional or local health and safety concerns, the goal of harmonization is agreement on appropriate scientific and other non-economic bases for setting standards, not a single international set of standards. Proponents of harmonization argue that equivalent standards among countries would promote international economic development by facilitating trade. Critics on the other hand are fearful of weakening U.S. standards and compromising "sovereign rights." They favor harmonization only if countries with less stringent food safety standards are obliged to meet more stringent U.S. standards, a process referred to as "upward harmonization." It is not clear whether they also would favor U.S. adoption of more stringent standards established by other countries.

U.S. agencies have participated for years in the activities of an organization sponsored by the United Nations, the Codex Alimentarius (that is, "food code") Commission, which negotiates international criteria for chemical testing, certification, and laboratory accreditation. The FQPA amends FFDCA Section 408 to encourage EPA to set tolerances at the "Maximum Residue Levels" (MRLs) established by the Codex, if such standards exist. If EPA chooses not to adopt the Codex MRL, the FQPA requires the agency to publish a notice in the Federal Register explaining why.

Issues Considered and Dropped Prior to Passage

Preempting State, Tribal, and Local Pesticide Use Laws

Those who register and distribute pesticides sometimes complain that given federal standards, local and state pesticide use restrictions are unnecessary and burdensome to commerce. FIFRA specifically authorizes state regulation of the sale and use of federally registered pesticides, as long as state regulations are at least as restrictive as federal standards. Under FIFRA, for example, states may prohibit the distribution and sale of a federally registered pesticide or restrict pesticide use locally to protect groundwater, wildlife, or human health. (The FQPA does not allow labeling or packaging requirements on pesticides in addition to, or different from, FIFRA requirements.) Where states have not enacted preemptive legislation, local jurisdictions also have the authority under FIFRA to regulate pesticide sales and use, according to the U.S. Supreme Court (Wisconsin Public Intervenor v. Mortier, 111 S.Ct.2321). Environmentalists and some states' rights advocates are determined to preserve this interpretation of FIFRA. The Coalition for Sensible Pesticide Policy, an umbrella group for many representing manufacturers and users of pesticides, proposed to amend FIFRA to establish federal preemption of state regulations and state preemption of local ordinances to facilitate national distribution of pesticide products.24

H.R. 1627, Section 106, as reported by the House Committee on Agriculture, would have prohibited local, but not state regulation of pesticide products. NASDA strongly supported preemption of local pesticide use restrictions, but many states did not. This preemption provision was dropped after the bill was reported in the House but before the bill was debated on the House floor. (FFDCA federal preemption authority is discussed below.)

Clarifying and Limiting Tribal Pesticide Enforcement

H.R. 1627, Title VI would have authorized Indian tribes to regulate the sale or use of any federally registered pesticide or device and to enforce against violations of pesticide use laws within the boundaries of a federal Indian reservation for such tribe, but would have prohibited these tribal activities if less than 50% of such lands were owned by members of the tribe or the tribe. The FQPA, as enacted, does not include this title.

In general, with regard to pesticide laws, EPA treats tribes in the same way it treats states. EPA has approximately 23 cooperative enforcement agreements with tribes. These delegate to designated tribal officers certain authority to conduct activities related to enforcement, such as inspections of pesticide establishments, within reservation boundaries (including land owned by non-members). In addition, tribes may refer violations to EPA for enforcement under FIFRA. However, EPA does not delegate to tribes federal enforcement authority to invoke the penalty provisions in FIFRA. The Agency has encouraged tribes to adopt and implement pesticide laws and regulations that are similar to FIFRA. Where they have done so, tribes enforce tribal codes.

Some who supported Title VI argued during debate on the House floor that states rather than tribes should enforce pesticide laws within reservation boundaries on land owned by people who are not tribal members, if most land within reservation boundaries is owned by nonmembers of the tribe.25 However, tribes opposed this provision, as did the Clinton Administration. The Administration expressed strong support for tribal authority to regulate pesticide use on all lands within tribal jurisdiction, arguing that the federal government lacks resources to implement pesticide programs at the local level, and that significant gaps in environmental protection on reservations might be created if tribal authority were limited. EPA claimed that the historical record of tribal regulation of pesticide use on reservation lands "is one of sensible environmental protection, respect, cooperation, and a few, well-justified enforcement actions" (Goldman, Lynn R., Letter to the Honorable Pat Roberts, Aug. 1, 1995). Four tribal enforcement actions are recorded by EPA Headquarters, three in South Dakota and one in Idaho.

Conclusion

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. The FQPA aims to facilitate FIFRA registration and reregistration of pesticides for minor uses, including public health pesticides, antimicrobial pesticides, and reduced risk pesticides; to improve data collection relevant to pesticide residue risks to children; and to protect consumer health by requiring FFDCA tolerances for pesticide residues on food that are "safe" and provide "a reasonable certainty of no harm" from aggregate exposure. The new law tightly links EPA actions under FFDCA and FIFRA and requires both tolerances and registrations to be reviewed periodically.

The FQPA does not repeal the "zero-risk" Delaney Clause in FFDCA Section 409, but it does ensure that pesticide residues in processed foods are not governed by that provision. Instead, the FQPA subjects all pesticide residues in food to FFDCA Section 408 and tightens the safety standard. In the future, raw food tolerances, as well as tolerances for processed foods, must be "safe" and ensure with "a reasonable certainty" that no harm will result from exposure to that residue, other residues on other foods, other sources, and other pesticides that have the same toxic effects on people. Only pesticides with health effects that have no known threshold (e.g., some cancers) are excepted from the "safe" standard, only under specified conditions, and only if the increased risk is within strict limits.

Congressional Hearings

U.S. Congress. House. Committee on Agriculture. Subcommittee on Department Operations, Nutrition, and Foreign Agriculture. Food Quality Protection Act of 1995. Hearing, 104th Congress, 1st session, May 16, 1995. Washington, DC, Govt. Print. Off., 1995. 248 p.

U.S. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry, Subcommittee on Agricultural Research, Conservation, Forestry, and General Legislation. The Federal Insecticide, Fungicide, and Rodenticide Act (S. 958, S. 1478, and S. 2050). Hearing, 103rd Congress, 2nd session, July 28, 1994. Washington, DC, Govt. Print. Off., 1995. 145 p.

U.S. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry. Testimony from Administration Witnesses on Pesticide Legislation (S. 985, S. 1478, and S. 2050). Hearing, 103rd Congress, 2nd session, June 29, 1994. Washington, DC, Govt. Print. Off., 1995, 79 p.

Appendix A. Authorities and General Provisions of Pesticide Laws, as Amended by the FQPA

FIFRA Authority and General Provisions

FIFRA, as amended (7 USC 136-136y),26 requires the U.S. Environmental Protection Agency (EPA) to regulate the sale and use of pesticides in the United States through registration and labeling of the estimated 21,000 pesticide products currently in use.27 The Act directs EPA to restrict the use of pesticides as necessary to prevent unreasonable adverse effects on people and the environment, taking into account the economic, social, and environmental costs and benefits of various pesticide uses. To this end, EPA registers each pesticide for each approved use, for example, to control boll weevils on cotton. FIFRA prohibits sale of any pesticide in the United States unless it is registered. In addition, FIFRA requires EPA to reregister older pesticides based on new data that meet current regulatory and scientific standards. Most pesticides currently registered in the United States are older pesticides and were not subject to the modern safety reviews.

When pesticide manufacturers apply to register or reregister a pesticide active ingredient or a particular use of a registered pesticide, EPA requires them to submit scientific data on pesticide toxicity and behavior in the environment. EPA may require any combination of more than 100 different tests. To register a pesticide use on food, EPA also requires applicants to identify analytical methods that can be used to test food for residues and to provide data on the amount of pesticide residue that could remain on crops as well as on (or in) food products, assuming that the pesticide is applied according to the manufacturers' recommended rates and methods. Based on the data submitted, EPA determines whether and under what conditions the proposed pesticide use presents an unreasonable risk to human health or the environment, and if proposed for use on a food crop, whether a safe level of pesticide residue can be established. Establishing a safe level of residue is necessary before granting a pesticide registration for a food-use. If a registration is granted, the Agency specifies the approved uses and conditions of use, which the registrant must explain on the product label. FIFRA requires that federal regulations for pesticide labels preempt state, local, and tribal regulations. Use of a pesticide product in a manner inconsistent with its label is prohibited.

EPA may classify and register a pesticide product for general or restricted use. Restricted-use products are considered more dangerous (to the applicator or the environment) and can be used only by trained pesticide applicators certified by states. Individual states and Indian tribes generally are responsible for training pesticide applicators for certification.

EPA also evaluates the safety of pesticides after they are registered (or reregistered). Registrants are required to report promptly any new evidence of adverse effects of pesticide exposure. If evidence indicates that a registered pesticide may pose an unreasonable risk, EPA may initiate a special review of available information and may reevaluate the risks and benefits of each registered use. Registrants also may be required to conduct new studies to fill gaps in scientific understanding to permit risk assessments. If a special review or reregistration evaluation finds that a registered use may cause "unreasonable adverse effects," the registration may be amended or canceled.28 Registrants also may voluntarily request cancellation or amendment of a registration to terminate selected pesticide uses. A request for voluntary cancellation sometimes reflects a registrant's conclusion that the cost of additional studies is not worth the expected benefit (that is, profit) from sales if the registration is maintained.

If a registration is canceled for one or more uses of a pesticide, it may no longer be sold or distributed for those uses in the United States, although for a specified period of time, U.S. farmers may use remaining stocks, and commerce may continue for commodities that were legally treated with the pesticide. An EPA decision to cancel a registration may be appealed by the registrant. An appeal initiates a lengthy decision review process during which the product may continue to be marketed. However, if there is threat of an "imminent hazard" during the time required to cancel registration, EPA is authorized to suspend registration. Suspension orders, which also may be appealed, stop sales and use of the pesticide.

Generally, FIFRA requirements are enforced by EPA. However, FIFRA Section 26 gives states primary authority, including inspection authority, for enforcing FIFRA provisions related to pesticide use.

Prior to enactment of P.L 104-170, the last significant changes to the general provisions of FIFRA were enacted in 1988 (P.L. 100-352). Authorization for appropriations expired on September 30, 1991, although appropriations have continued. The history and provisions of FIFRA prior to the 1996 amendments are summarized in CRS Report 95-59 ENR, Summaries of Environmental Laws Administered by the Environmental Protection Agency, pages 83-90.

FFDCA Authority and General Provisions

FFDCA, as amended (21 USC 301-392), requires various federal agencies to regulate foods, drugs, and cosmetics to ensure that they are safe for use. For the approximately 300 pesticides registered for use in food production, the FFDCA directs EPA to establish allowable pesticide residue levels (called tolerances) in food and animal feed. Under FFDCA, foods with a residue of a pesticide for which there is no tolerance established, or with a residue level exceeding an established tolerance limit, are declared "unsafe" and "adulterated;" such foods cannot be sold in interstate commerce in the United States.

Any person who has registered a pesticide may petition EPA proposing establishment of a tolerance or an exemption for that pesticide to permit its use on food.29 Tolerance petitions must include information about pesticide application rates, measured concentrations of pesticide residues on the food after the pesticide has been applied according to directions on its label, and safety of pesticide use on food. FFDCA requires EPA to respond to each petition by establishing a tolerance or exempting the pesticide from the requirement. If the pesticide will not leave residues above an established safe level, EPA will register the pesticide for use on that food and set the tolerance level by issuing a regulation. EPA tolerances for pesticide residues preempt state and local restrictions on food if they are based on lower residue levels. States may petition for an exception if the residue level threatens public health.

Prior to P.L. 104-170, the FFDCA directed EPA to establish tolerances for pesticide residues on food according to criteria which differed for raw and processed commodities. Residues in raw commodities were subject to Section 408 of FFDCA. This provision required that residue tolerances be set at levels necessary to protect public health considering: 1) "the necessity for the production of an adequate, wholesome, and economical food supply," and 2) the opinion of the Secretary of Agriculture as to the usefulness of the pesticide. EPA interpreted this directive to require a balancing of risks and benefits in the setting of tolerances. If a tolerance was not necessary to protect public health, EPA was required to grant the pesticide an exemption from the requirement for a tolerance. Section 408 made no reference to cancer-causing chemicals.

In contrast, the former FFDCA treated pesticide residues in processed food as food additives, which are governed by Section 409. This provision requires tolerances for food additives to be based on "a fair evaluation of the data" establishing that the proposed use of the additive is safe. Moreover, Section 409(c)(3)(A) prohibits a finding that a food additive is safe, if it has been found "to induce cancer in man or animal," Thus, it prohibits the addition of potentially carcinogenic substances to foods. This FFDCA clause is known as the Delaney Clause. Notwithstanding the provisions of Section 409, however, a pesticide residue in processed food was not unsafe if it: resulted from pesticide use on a raw food in accord with a prescribed tolerance (or exemption), was "removed to the extent possible in good manufacturing practice," and was in ready-to-eat food at a concentration not greater than the tolerance for the raw food product (FFDCA Section 402(a)(2)(C)).30 A pesticide residue in processed food was "safe," therefore, if it had not concentrated during food processing. If it did concentrate, the food could be sold only if a food additive tolerance (i.e., a Section 409 tolerance) had been established (indicating that the pesticide residue was "safe" at or below that level), and the pesticide residue on the processed food was below that tolerance level, or an exemption had been granted for the pesticide in that food. However, if the pesticide was a potential carcinogen, no food additive tolerance could be established. Therefore, processed foods could contain no greater concentration of a potentially carcinogenic pesticide residue than was permitted in the same food before processing, and no residue at all if the pesticide was not used on the raw food. A 1992 decision by the U.S. Court of Appeals for the Ninth Circuit explicitly barred balancing of risks and costs in setting a Section 409 tolerance for a carcinogenic pesticide, no matter how small the cancer risk (Les V. EPA, CA 9, No.91-70234). This decision led EPA to propose revoking several food additive tolerances for potentially carcinogenic pesticide residues in processed foods.

Pesticide residues in processed food, even if they have concentrated during processing, are no longer subject to Section 409 or the Delaney Clause. All pesticide residues are regulated under the amended FFDCA Section 408. The standard for tolerance setting under this revised standard is that aggregate exposure to the pesticide must be "safe". See pages 11 to 12 in the main body of this report for more information about the revised food safety standard.

EPA has long coordinated pesticide registrations for food uses under FIFRA with tolerance setting under FFDCA. Public Law 104-170 codifies this policy. Thus, if EPA revokes a residue tolerance under FFDCA, it cancels the FIFRA pesticide registration for that food use. EPA explains, "Legally-used pesticides should not result in illegal food" (61 Federal Register 2379, Jan.25, 1996). EPA traces the origin of its coordination policy to the legislative history of FFDCA Section 408 (5. Rept. 1635, 83rd Cong., 2nd Sess. 1954, p.3). Similarly, if a pesticide registration for use on a food crop is canceled, EPA also cancels the residue tolerance for the food. However, just as FIFRA allows continued use of remaining pesticide stocks after a registration is canceled, FFDCA allows continued commerce in commodities legally treated with a pesticide. Thus, EPA does not immediately revoke the tolerance for the pesticide residue, when it cancels the corresponding registration. (Formerly, the Agency also coordinated pesticide residue tolerances for raw foods with food additive tolerances for the corresponding processed foods: when it revoked a Section 409 (food additive) tolerance for a processed food, it also revoked the corresponding tolerance for the raw agricultural commodity. This effort will no longer be required as both raw and processed foods are subject to the same Section 408 tolerance.)

FFDCA directs the Food and Drug Administration (FDA) in the Department of Health and Human Services (DHHS) and U.S. Department of Agriculture (USDA) to monitor pesticide residue levels in food in interstate commerce and to enforce tolerances through their food inspection programs. USDA is responsible for inspecting meat and poultry; FDA inspects all other foods. States also may monitor pesticide residues in food sold within their jurisdictions.

Prior to P.L. 104-170, FFDCA provisions related to pesticide residues on food were last significantly amended in 1958 by the Food Additives Amendments of 1958 (P.L. 85-929). There is no specific authorization for FFDCA appropriations.

ENDNOTES

22 U.S. GAO. Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food, GAO/RCED-94-192. Gaithersburg, MD. p.50.

23 Ibid

24 According to its literature, the Coalition for Sensible Pesticide Policy consists of state, regional and national trade associations for users and manufacturers of pesticides. Members include associations for nursery, arbor, floral, lawn and garden, agricultural, and structural pest control companies, as well as the American Farm Bureau Federation, the National Association of State Departments of Agriculture, and the U.S. Chamber of Commerce.

25 The Honorable Doug Bereuter, Congressional record, July 24, 1996, p. H8146.

26 FIFRA also is known as the Act of June 25, 1947.

27 Exceptions are noted in 40 CFR 152.20, 152.25, and 152.30.

28 Registrations also may be canceled under other conditions, for example, if data are not submitted in response to EPA's request for additional information to maintain a registration or if a registrant fails to pay the maintenance fee.

29 That Is, use on food crops, animal feed crops, or food products directly (e.g., grains, fruits, or vegetables after harvest).

30 Section 402 has become known as the "flow-through" provision. This means that if the amount of the pesticide residue in the processed food is less than the tolerance for the raw food, then EPA does not need to establish a tolerance under Section 409.

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