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

CONTENTS FOR THIS SECTION

Food Safety Provisions and Amendments to the Federal Food, Drug,and Cosmetic Act

Reducing Reregistration Delays
Protecting Infants and Children from Pesticide Residues in the Diet Revising Tolerance-Setting Criteria for Pesticide Residues in Food

The Delaney Clause
A New Standard of Food Safety
Costs and Benefits
Other Provisions Affecting Tolerances

Preempting State Pesticide Residue Tolerances

Food Safety Provisions and Amendments to the Federal Food, Drug, and Cosmetic Act

Reducing Reregistration Delays

Since 1972, FIFRA has required EPA to reregister older pesticides based on data that meet current registration and scientific standards. Long concerned with EPA's progress in reregistration, Congress strengthened and accelerated FIFRA requirements in 1988 and directed the Agency to reregister by 1997 all pesticides originally registered before 1984, when less toxicity information was available. By September 30, 1995, EPA had completed reregistration actions for 170 or about 30% of the active pesticide ingredients for which manufacturers support reregistration. Early in 1996, EPA expected to complete reregistration by the end of FY2004, 7 years after the 1988-mandated deadline of FY1997.

During the debate over H.R. 1627, EPA argued that timely completion of reregistration required that Congress increase and extend EPA's funding authority; this authority would have expired September 30, 1997.7 Reregistration is financed through a combination of appropriated funds and registration "maintenance" fees paid by pesticide manufacturers. Fee collections have been lower and costs higher than originally anticipated, according to EPA. EPA and pesticide registrants agreed upon a schedule of increased revenues that Congress authorized in a package of technical amendments to the 1990 farm bill (P.L. 102-237). It increased the annual registration maintenance fee cap while allowing continued agency discretion to adjust product fees to generate $14 million annually to carry out reregistration. In spite of this change, last year EPA estimated a budget deficit of $105 million to complete reregistration. In 1996, the Assistant Administrator for Prevention, Pesticides., and Toxic Substances predicted that FY1996 registration and reregistration would be at least 20% less than in FY1995 due to budget constraints and the government shutdown.

The FQPA, Title V, extends EPA authorization to collect $14 million annually in registration maintenance fees from pesticide registrants until the end of FY2OO1. It authorizes collection of up to $2 million in additional fees in FY1998, FY1999, and FY2OOO. EPA is required to complete processing of all pending applications for expedited review within 5 years of enactment.

Although pesticide manufacturers supported this extension of the maintenance fees, they argued that historical funding levels had been adequate, and they questioned whether EPA had managed funds efficiently. The industry wanted the Agency to develop a system of accountability for expenditures on reregistration. A recent General Accounting Office (GAO) report responding to a request by the House Committee on Agriculture appeared to support industry's position.8 GAO recommended that Congress require a fiscal 1996 full scope audit of the FIFRA fund to consider "the reasonableness of the overhead allocation and the adequacy of disclosures of direct and indirect costs."9 In addition, EPA should prepare a schedule for the reregistration process indicating how many reregistration decisions will be completed each year and specifying the chemical cases to which decisions will apply, according to the report. GAO indicated that such measures would allow Congress to oversee EPA efforts to ensure that the high-risk pesticides are addressed first. (FIFRA requires EPA to give priority in reregistration to certain pesticides, including pesticide active ingredients used on food that may result in post-harvest residues (7 USC 136a-1(c)(1)(A)). GAO suggested amending H.R. 1627 to incorporate these recommendations.

As GAO suggested, Congress enacted FQPA provisions directing EPA to establish and publish annually performance measures and goals, including goals for reregistration, and to ensure that expenditures from fees are used only to accomplish those goals. The FQPA also requires an annual audit of the fees collected and disbursed, and EPA attainment of performance goals.

One reason for higher than expected costs and reregistration delays has been late and deficient reregistration package submissions, according to EPA, and these problems are being addressed. EPA requires manufacturers applying to register or reregister a pesticide to submit reports of scientific studies on pesticide toxicity and behavior in the environment. The Agency requires that studies conducted by industry conform to EPA standards of scientific quality.

Studies that do not meet EPA standards are rejected and must be repeated and then reevaluated. Rejected studies contribute to the high cost of registration. While pesticide registrants have argued that EPA's scientific standards for maintaining pesticide registrations are excessive, EPA has insisted that registration decisions should be based on the best available science. In the past, EPA rejected approximately 30% of studies submitted. A 1991 analysis of factors contributing to late and deficient study submissions prompted a joint EPA-industry project to improve performance. Due to workshops, additional EPA guidance, and independent efforts of individual companies, the study rejection rate today is half of what it was 3 years ago and many submissions are more timely, according to EPA.

Some argued that industries have little incentive to submit timely and adequate applications to maintain registrations of older pesticides; while a decision is pending about the safety of the older pesticides, manufacturers may continue to market them. The sooner the application is complete the sooner EPA will be able to make a reregistration eligibility decision (RED), and there is no guarantee that EPA will declare the pesticide eligible to be reregistered for all uses, given current safety standards. Delayed REDs (and delayed potential registration cancellations), in turn, reduce demand for alternative pesticide products. This is true in part because new product alternatives, although they may be less hazardous and equivalently effective for similar uses, tend to be more expensive than older products that have not been subjected to the full battery of safety studies, giving them a competitive advantage over newer pesticides.

Provisions of the FQPA meant to reduce potential disincentives to registration and reregistration of certain minor-use pesticides were discussed above. In addition, the FQPA directs the Administrator to require the submission of data when necessary for registration review which the FQPA requires periodically, with a goal of every 15 years. To ensure data submission in a timely manner, the FQPA requires EPA to suspend a registration if the registrant fails to take appropriate steps to secure the data required within the time required by the Administrator.

Protecting Infants and Children from Pesticide Residues in the Diet

For several years, Congress has been concerned about pesticide residues in the diets of infants and children. A 1993 National Academy of Sciences (NAS), National Research Council (NRC) report concluded that there are both quantitative and sometimes qualitative differences between children and adults in toxicity of pesticides and in exposure to pesticide residues in foods.10 It recommended that "better data on dietary exposure to pesticide residues should be combined with improved information on the potentially harmful effects of pesticides on infants and children."11 Information on the potentially harmful effects of pesticides would be improved, it stated, by toxicological testing of pesticides to determine perinatal and childhood toxicity and developing better methods to estimate exposure and the magnitude of potential adverse health effects. The committee also advised EPA to revise its process for setting pesticide residue tolerances under the FFDCA so as to safeguard the health of infants and children.

The FQPA, Title III requires that the USDA Secretary, in consultation with EPA and DHHS --

· develop and implement procedures to collect data on food consumption patterns of infants and children;

· improve residue data collection by providing guidelines for analysis and reporting and increasing sampling of foods most likely consumed by infants and children; and

· collect data of statewide or regional significance on pesticide use on major crops and crops of dietary significance.

In addition, EPA is required to ensure that pesticide tolerances adequately safeguard the health of infants and children (Section 405, amending FFDCA Section 408(b)(1)(E)).

Some scientists have argued that data gathering provisions alone are not adequate to protect the health of infants and children; their sensitivities and exposures must be taken into account in risk assessment and tolerance setting, these scientists say. The Administration asked Congress to require EPA to consider the diets and sensitivity of children in setting tolerances.12 Congress added such provisions by amending tolerance setting procedures of the FFDCA Section 408. (See the discussion below.)

In addition, Title III requires EPA to report to Congress on progress in improving federal efforts to collect pesticide use information, including an analysis of the quality and reliability of information collected by USDA, EPA, and other federal agencies and of options to improve performance with respect to costs, burdens on pesticide users, and tracking of risk reduction.

Revising Tolerance-Setting Criteria for Pesticide Residues in Food

The Delaney Clause. A key issue in the 104th Congress was whether to revise the so-called "zero-risk" standard of the Delaney Clause (FFDCA, Section 409) which prohibits the addition of potentially cancer-causing substances to foods. The application of the Delaney Clause to pesticide residues has been criticized for being unscientific and creating a confusing and inconsistent set of standards for safety, depending on whether a pesticide was on a raw or processed food and whether it was a carcinogen or not.

Critics of pesticide regulation under the Delaney Clause maintained that it was unscientific, because very small pesticide residues pose no significant risk to health. Technology is now sophisticated enough to detect extremely small amounts of pesticides in food, in some cases levels of parts per trillion. Thus, food industry representatives claimed that rigid enforcement of the Delaney Clause (i.e., banning any measurable pesticide concentration) stifled research and development of new pesticides which might have been safer than products on the market. Critics noted that many foods contain natural carcinogens (which are not regulated under Delaney) that may be more concentrated and more potent than pesticide chemical residues; they said that residues might even have resulted from pesticide use to control fungi or bacteria that produce natural carcinogens. In addition, they claimed that in some cases, the distinction between raw and processed foods made no sense: the absolute amount of pesticide in a food before and after processing might be the same, yet a tolerance could be set for the residue in raw food and prohibited for the residue in processed food, because the residue had concentrated relative to the total food weight (due to drying or other processing).

Delaney Clause supporters argued that the public does not want to be exposed to carcinogenic pesticides in their food, no matter how small the risk. With regard to naturally occurring carcinogens in food, they argued that federal agencies could not readily assess and reduce that risk, especially since natural anti-carcinogens often are found in the same food as the carcinogens. To reduce the overall cancer risk, therefore, they believe the federal government should minimize pesticide chemical residues in food.

The Delaney Clause also was problematic, according to some, because it required regulators to treat potentially carcinogenic pesticides more stringently than pesticides that may exert other health effects. This situation set up a paradox: by stringently regulating carcinogens, Section 409 may have reduced the safety of some foods. Section 409 allowed approval of pesticide residues that posed greater risks than residues of carcinogens which Section 409 did not permit, because many registered pesticide products have health effects other than cancer. For this reason, the National Research Council (NRC) of the National Academy of Sciences recommended in 1987 that all pesticide residues in food, whether raw or processed, should be regulated on the basis of a consistent "negligible risk" standard.13

A New Standard of Food Safety. H.R. 1627, as introduced, proposed a single "negligible risk" standard for pesticide residue tolerances. This provision was strongly supported by food processors, growers, the agricultural chemical industry, and the National Association of State Departments of Agriculture (NASDA). Others preferred keeping the "zero-risk" standard and phasing out the use on food of pesticides classified as "probable human carcinogens."14

The Administration favored a single statutory standard for pesticide residues in raw and processed food. However, it argued that for pesticide residues with health effects other than cancer, such as birth defects or neurotoxicity, it was unclear how a negligible risk standard would apply.15 EPA wanted to set tolerances based on the health-based standard for non-carcinogens in the FFDCA, Section 409-- "a reasonable certainty of no harm."16 The Administration's view is reflected in the FQPA.

The FQPA, Title IV amended the FFDCA, but did not amend or repeal Section 409 which contains the Delaney Clause; Section 409 remains in effect for food additives that are not pesticide residues. Rather, the FQPA redefined terms such as "pesticide chemical" and "food additive" so that residues of pesticides in processed as well as raw foods will be regulated under an amended Section 408, rather than under Section 409. Section 408 tolerances also will apply to residues of breakdown products of pesticides -- i.e., substances resulting from metabolism or degradation of pesticides -- and to residues of inert ingredients and their breakdown products in raw and processed food.

As amended by the FQPA, Section 408 authorizes EPA to set a tolerance for a pesticide residue in or on food (whether raw or processed) only if the Administrator decides that the tolerance is "safe." A "safe" tolerance is defined as a level at which there is "a reasonable certainty of no harm" from the exposure. This is the same standard that formerly was applied to non-carcinogenic pesticide residues in processed foods under Section 409. However, the new law requires EPA to assess safety in terms of total exposure to the pesticide (that is, to the concentration of pesticide allowed by the tolerance together with all other dietary and non-food exposures for which there is reliable information) and to other pesticides that have the same toxic effects on people. No quantitative standard of safety is established by the new law, but the Committee on Commerce expects EPA to continue setting standards to ensure safety as it has in the past:

the Committee expects that a tolerance will provide a 'reasonable certainty of no harm' if the Administrator determines that the aggregate exposure to the pesticide chemical residue will be lower by an ample margin of safety than the level at which the pesticide chemical residue will not cause or contribute to any known or anticipated harm to human health. The Committee further expects, based on discussions with the Environmental Protection Agency, that the Administrator will interpret an ample margin of safety to be a 100-fold safety factor applied to the scientifically determined 'no observable effect' level when data are extrapolated from animal studies.17

In determining a safe level, EPA is directed to take into account many factors, including available information on dietary exposure to pesticides among infants and children.

Costs and Benefits. Prior to P.L. 104-170, EPA set tolerances for pesticide residues in processed foods under Section 409 to ensure that they were safe, without considering benefits of pesticide use. In contrast, EPA balanced risks and benefits in setting tolerances under Section 408. H.R. 1627, as introduced, would have regulated pesticide residues under the old Section 408 standard. It also would have allowed EPA to set tolerances for residues posing more than a negligible risk if the risk were "not unreasonable" relative to the benefits of pesticide use. The Administration objected to this proposal. In its view, agencies should weigh only health risks and benefits that accrue to consumers, without consideration of the "broader benefits considerations, such as regional benefits, regional economic benefits, or economic benefits that are not direct benefits to consumers."18 In contrast, NASDA wanted benefits to the agricultural economy weighed against the risks of pesticide use.

As enacted, FQPA strictly limits the nature and influence of benefits considered in tolerance setting under Section 408. It allows EPA to maintain or modify existing tolerances (but not to establish new tolerances) at higher than "safe" residue levels only if the pesticide use avoids other greater risks to consumers or is necessary to avoid significant disruption in domestic production of an adequate, wholesome, and economical food supply. Such higher tolerance levels may be set only for pesticides that are potential carcinogens (or have some other health effect) for which there is no known level of exposure at which no harm is anticipated (known as a non-threshold effect). The higher tolerance level allowed for such pesticide residues must be "safe" for infants and children as well as with respect to health effects for which there is a known threshold (that is, a level below which exposure is known to be harmless). The higher cancer (or other non-threshold) risk posed by the tolerance may not be more than 10 times the risk at a "safe" level of exposure on an annual basis and not more than twice the risk of a "safe" level over a lifetime.

For nonthreshold effects, the House Commerce Committee provided additional guidance for establishing a level of residue that should be considered "safe."

In the case of a nonthreshold effect which can be assessed through quantitative risk assessment, such as a cancer effect, the Committee expects, based on its understanding of current EPA practice, that a tolerance will be considered to provide a 'reasonable certainty of no harm' if any increase in lifetime risk, based on quantitative risk assessment using conservative assumptions, will be no greater than 'negligible.' It is the Committee's understanding that, under current EPA practice, ... EPA interprets a negligible risk to be a one-in-a-million lifetime risk. The Committee expects the Administrator to continue to follow this interpretation.19

The FQPA also requires EPA to distribute to major food stores nationwide easily understood information for public display about the risks and benefits of such pesticide residues on food and how consumers may avoid the risks without sacrificing nutrition.

The National Coalition Against the Misuse of Pesticides reportedly has criticized the new law for "legalizing levels of pesticides that cause cancer and other adverse effects."20 However, very small risks from low concentrations of pesticide residues such as those permitted under the FQPA also were permitted prior to passage of the new law. In addition, low concentrations of potential carcinogens were legal on raw food before passage of the FQPA, as long as the risks were reasonable considering the benefits of the pesticide. The new Section 408 tightens the standard for pesticide residues in food. 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. Moreover, the new law allows growers to avoid use of pesticides that pose relatively large risks of health effects other than cancer by allowing pesticide residues in processed foods that pose smaller cancer risks.

Other Provisions Affecting Tolerances. The FQPA directs EPA to develop a screening program to evaluate whether pesticides may have effects in humans that are similar to effects produced by naturally occurring estrogen or other endocrine effects. If EPA finds such effects, it is required to use its existing statutory authority to ensure the protection of public health.

Finally, the FQPA directs EPA to review within 10 years of enactment all pesticide residue tolerances and exemptions in effect before enactment. It authorizes anyone to petition EPA to establish, modify, or revoke a tolerance or an exemption, and provides 60 days for public comments on pending proposals. In addition, a person adversely affected by a final regulation has twice the time provided under previous law --60 days rather than 30-- to file an objection.

Preempting State Pesticide Residue Tolerances

Although federal pesticide residue tolerances are typically accepted across the nation, the FFDCA, before it was amended by P.L. 104-170, authorized states to impose tighter restrictions. For example, California requires businesses to warn the public about pesticide residues on food that pose a "significant risk" (defined as more risky than one chance in 100,000) of causing cancer or birth defects. The agricultural sector, particularly the food industry, wanted federal standards to preempt state standards. The National Food Processors Association argued that differing state tolerances disrupt interstate commerce. In addition, it said farmers in states with tighter standards might be at a competitive disadvantage to those in states with weaker regulations or enforcement. Supporters of the balance of authority reflected by the FFDCA before amendment argued that unique regional demographic or food consumption characteristics made it prudent to allow states flexibility concerning food safety. Such flexibility is built into most environmental federal laws. EPA opposed preemption, while NASDA supported preemption of tolerance setting and warning requirements.

The FQPA establishes federal preemptive authority over tolerance setting and exemptions when federal standards ensure that residues are "safe", but allows for state action under compelling local conditions with EPA approval. State and local laws requiring a warning when a pesticide residue is present in food are permitted.21

ENDNOTES

7 The President's "Balanced Budget Act of 1995 for Economic Growth and Fairness" proposes extending until 1999 existing EPA authority to impose maintenance fees; this authority expires in FY 1997. The President also would authorize collection of additional fees to support reregistration.

8 U.S. GAO. FIFRA Reporting Requirements. GAO/AIMD/RCED-96-21R. Gaithersburg, MD.

9 Ibid.

10 Pesticides in the Diets of lnfants and Children, Washington, DC, National Academy Press. (1993) 386 p.

11 Ibid. p.12.

12 Congress. House. Committee on Agriculture. Subcommittee on Department Operations, Nutrition, and Foreign Agriculture. Food Quality Protection Act of 1995. Hearing, 104th Cong., 1st Sess., May 16,1995. Washington, U.S. Govt. Print. Off., 1995. p.15.

13 National Research Council, National Academy of Sciences. Regulating Pesticides in Foods: The Delaney Paradox, Washington, National Academy Press, 1987.272 p.

14 Depending on the overall weight of scientific evidence for carcinogenicity, EPA has classified some chemicals, including pesticides, as:

Group A - Known human carcinogens
Group B - Probable human carcinogens
Group C - Possible human carcinogens
Group D - Inadequate evidence to classify, or
Group E - Not likely to be carcinogenic to humans

This classification scheme may soon change: EPA has proposed new guidelines for cancer risk assessment. The new scheme would describe the cancer-causing potential of a chemical in a narrative up to two pages long. Carcinogenic potential would be categorized as "likely," "known," "not likely," and "cannot be determined."

15 U.S. Congress. House. Committee on Agriculture. Subcommittee on Department Operations, Nutrition, and Foreign Agriculture. Food Quality Protection Act of 1995. Hearing, 104th Cong., 1st Sess., May 16,1995. Washington, U.S. Govt. Print. Off., 1995. p.15.

16 The phrase "a reasonable certainty of no harm" is taken from the legislative history of FFD CA, Section 409: "Safety requires proof of a reasonable certainty that no harm will result from a proposed use of an additive. It does not -- and cannot -- require proof beyond any possible doubt that no harm will result under any conceivable circumstance" (H. Rept. 2284, 85th Cong., 2d Sess. (1958)).

17 U.S. House. Committee on Commerce. Food Quality Protection Act of 1996, H.Rept. 104-669, Part 2, 104th Congress, 2nd Sess. 1996. p.6.

18 Ibid.

19 Ibid.

20 Broderick, Brian, "House repeals Delaney Clause in compromise FIFRA, FFDCA bill, Daily Environmental News, July 24,1996. Bureau of National Mfairs, Washington, p. A-1.

21 The introduced version of H.R. 1627 would have preempted such warnings, but this provision was dropped from the reported bill.

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