FRIDAY

February 5, 1993





Part VI

Environmental Protection Agency





Request for Comment on Petition to Modify Policy on Pesticide Tolerances; Notice


(This reprint was prepared from the electronic file that accompanied the original signed documents transmitted to the Office of the Federal Register. This file was certified to be a true copy of the original.)

(This document appeared at 58 FR 7470 - 7475.)

Federal Register / Vol. 58, No. ? / day, January 00, 1993 / Notices
ENVIRONMENTAL PROTECTION AGENCY
 [OPP - 260053; FRL - 4185 - 1]


Pesticides; Request for Comment on Petition to Modify EPA Policy on Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of receipt and availability of petition.




SUMMARY: This document announces the receipt of and solicits comments on a petition which asks that EPA change its policies related to establishing tolerances for raw and processed foods under the Federal Food, Drug and Cosmetic Act (FFDCA). This petition is of interest in light of a recent court decision involving the Delaney clause of the FFDCA which requires EPA to revoke tolerances for certain cancer-causing pesticides in processed foods. EPA's current policy is that it will generally not allow a pesticide to be used on any raw commodity where a food additive regulation for a food processed from that commodity is barred by the FFDCA. The petition challenges this policy as illegal and unsound and also challenges how EPA determines whether a food additive regulation is needed. This notice seeks comment on this issue and also describes and seeks comments on other issues and policies EPA must consider in determining which pesticide uses are affected by the court ruling in Les v. Reilly, 968 F.2d 985 (9th Cir.).
DATES: Written comments, identified by the document control number [OPP - 260053] must be received on or before April 6, 1993.

ADDRESSES: By mail, requests for copies of the petition and comments should be forwarded to: Public Response and Program Resources Branch, Field Operations Division (H7506C), Office of Pesticide Programs, 401 M St., SW., Washington, DC 20460. Copies of the petition will be available for public inspection from 8 a.m. to 4:30 p.m., Monday through Friday, except legal holidays, at the Public Docket and Freedom of Information Section, Field Operations Division, Office of Pesticide Programs, Environmental Protection Agency, Rm. 1132, CM  2, 1921 Jefferson Davis Highway, Arlington, VA, Telephone: 703 - 305 - 5805.
    Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Otherwise, all written comments will be available for public inspection.
FOR FURTHER INFORMATION CONTACT: Lisa Engstrom, Office of Pesticide Programs (H7508W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone: 703 - 308 - 8031.
SUPPLEMENTARY INFORMATION:
Electronic Availability: This document is available as an electronic file on  The Federal Bulletin Board at 9:00 a.m. on the date of publication in the Federal Register. By modem dial (202) 512 - 1387 or call (202) 512 - 1530 for disks or paper copies. This file is also available in Postscript, Wordperfect and ASCII.

 I. Introduction

A. Statutory and Regulatory Framework

    Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), pesticides must be registered with the EPA before they may be sold, distributed, or used in the United States. To qualify for registration, a pesticide must, among other things, perform its intended function without causing ``unreasonable adverse effects to the environment.'' (7 U.S.C. 136a(c)(5)). The term ``unreasonable adverse effects'' is defined as ``any unreasonable risk to man or the environment taking into account the economic, social and environmental costs and benefits of the use of any pesticide.'' (7 U.S.C. 136(bb)). Thus, FIFRA requires EPA to balance the risks and benefits of a pesticide in determining whether or not to grant, or retain, a pesticide registration.
    The Federal Food, Drug and Cosmetic Act (FFDCA) [21 U.S.C. 301 et seq], authorizes the establishment of tolerances and exemptions from tolerances for the residues of pesticides in or on raw agricultural commodities (RAC) in section 408, and the promulgation of food additive regulations for pesticide residues in processed foods under section 409 of that Act [21 U.S.C. 346(a), 348].
    Under section 408, EPA establishes tolerances, or exemptions from tolerances when appropriate, for pesticide residues in raw agricultural commodities. Food additive regulations setting maximum permissible levels of pesticide residues in processed foods are established under section 409. Section 409 tolerances are required, however, only for certain pesticide residues in processed food. Under section 402(a)(2) of the FFDCA, no section 409 tolerance is required if any pesticide residue in a processed food resulting from use on a raw agricultural commodity is below the tolerance for that pesticide in or on the RAC. This exemption in section 402(a)(2) is commonly referred to as the ``flow-through'' provision because it allows the section 408 raw food tolerance to flow through to the processed food form. Thus, a section 409 tolerance is only necessary to prevent foods from being deemed adulterated when the concentration of the pesticide residue in a processed food is greater than the tolerance prescribed for the raw agricultural commodity, or if the processed food itself is treated or comes in contact with a pesticide. Monitoring and enforcement are carried out by the Federal Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA).
    To establish a tolerance or an exemption for pesticide residues on raw agricultural commodities under section 408 of the FFDCA, EPA must make a finding that the promulgation of the rule would ``protect the public health'' [21 U.S.C. 346a(b)]. In reaching this determination, the Agency is directed to consider, among other relevant factors: (1) the necessity for the production of an adequate, wholesome and economical food supply; (2) other ways in which the consumer may be affected by the pesticide; and (3) the usefulness of the pesticide for which a tolerance is sought. Thus, section 408 of the FFDCA requires the Agency to balance risks against benefits in determining whether to establish tolerances.
    The establishment of a food additive regulation under section 409 requires a finding that use of the pesticide will be ``safe'' [21 U.S.C. 348(c)(3)]. Section 409 also contains the Delaney clause, which specifically provides that, with limited exceptions, no additive may be approved if it has been found to induce cancer in man or animals. [21 U.S.C. 348(c)(5)]. Unlike FIFRA registrations and section 408 tolerances, a literal interpretation of the Delaney clause creates a ``zero risk'' standard that does not consider a risk/benefit balance in setting tolerances.
    To coordinate the administration of each of these statutory provisions, EPA has specified that FIFRA registrations for food-use pesticides will not be approved until all tolerance and food additive regulations associated with the use have been obtained. 40 CFR 152.112(g). In addition, it is EPA's current policy that a section 408 raw food tolerance generally will not be established or maintained if a section 409 food additive tolerance for the same pesticide residue in the resulting processed food is needed but cannot be approved (53 FR 41104, 41108, October 19, 1988). This policy, which is also referred to in this document as the ``EPA's coordination policy,'' is discussed further in Units II and III of this notice.

B. EPA's Tolerance Setting Process

    In setting both 408 and 409 tolerances, EPA reviews residue chemistry and toxicology data. To be acceptable, tolerances must be both high enough to cover residues likely to be left when the pesticide is used in accordance with its labeling, and low enough to protect the public health. With respect to section 408 tolerances, EPA determines the highest levels of residues that might be present in a raw agricultural commodity based on controlled field trials conducted under the conditions allowed by the product's labeling that are expected to yield maximum residues.
    EPA's policy concerning when a section 409 tolerance is needed turns on whether there is a possibility that the processing of a raw agricultural commodity containing pesticide residues would result in residues in the processed food at a level greater than the raw food tolerance. As discussed in Part III of this notice, EPA considers several factors in evaluating processing studies to determine when a 409 tolerance is needed. When a 409 tolerance is needed, the level of the food additive regulation is determined by multiplying the raw food tolerance level by the greatest degree of concentration measured in the processing study. Thus, theoretically, residues in processed food should not exceed the level of the food additive regulation even when the residue in the raw food which was processed is at or near the tolerance level.

C. Background of Proceedings

    In February 1985, EPA commissioned the Board on Agriculture of the National Research Council/National Academy of Sciences (NAS) to examine the impact of the conflicting standards for regulating pesticides discussed above. In the report, ``Regulating Pesticides in Food: The Delaney Paradox'' (NAS, May 29, 1987), NAS recommended that the ``zero-risk'' Delaney clause be replaced by a ``negligible risk'' standard for both raw and processed foods. The NAS thought a negligible risk standard could dramatically reduce total dietary exposure to carcinogenic pesticides with a modest reduction of benefits.
    Following recommendations from the NAS report, EPA published in the Federal Register (53 FR 41104, October 19, 1988) a policy statement announcing that it would treat the Delaney clause as subject to a de minimis exception where the human dietary risk from residues of the pesticide is, at most, negligible. The de minimis exception to the Delaney clause is premised on case law holding that an administrative agency ordinarily has the inherent authority to avoid applying the terms of a statute literally when to do so would yield pointless results. The 1988 policy statement further asserted that a legislative change would be the only way to reconcile the statutory standards fully.
    In 1989, President Bush announced a comprehensive legislative proposal addressing pesticides and food safety including, among other things, a provision which would eliminate the long-standing inconsistency in the laws governing pesticide residues in food and establish instead a negligible risk standard for all food. This proposal was consistent with the NAS recommendation and would have eliminated the conflict which is subject of the petition discussed in this notice. Although Congress has considered a number of food safety bills, no legislation has passed.
    On May 25, 1989, the State of California, the Natural Resources Defense Council, Public Citizen, the AFL-CIO, and several individuals filed a petition (``California petition'') requesting that EPA revoke several food additive regulations and challenging EPA's de minimis interpretation of the Delaney clause. The petition, which sought a ``zero risk'' interpretation of the Delaney clause, requested that EPA revoke the following food additive regulations: trifluralin (spearmint and peppermint oils), benomyl (raisins and tomato products), phosmet (cottonseed oil), mancozeb (raisins, and brans of barley, oats, rye and wheat), dicofol (dried tea), DDVP (packaged and bagged nonperishable processed foods and dried figs), and chlordimeform (dried prunes) (54 FR 27700, June 30, 1989). The petitioners argued that these food additive regulations should be revoked because the seven pesticides to which the regulations apply are animal carcinogens, and thus may not continue in effect due to the Delaney clause.
    EPA responded to the California petition on April 18, 1990 (55 FR 17560, April 25, 1990). EPA agreed to revoke several food additive regulations for which there were no longer any registered pesticide uses. EPA declined, however, to revoke the remaining food additive regulations based on determinations that either:
    1. The food additive posed de minimis risk and that the Delaney clause contained an exception for pesticides posing a de minimis risk.
     2. There was insufficient information to determine whether the food additive regulation posed a de minimis risk and EPA believed that data to be submitted in the future would show the risk from the food additive to be de minimis.
    3. Action under FFDCA was appropriately withheld pending completion of an ongoing FIFRA proceeding, such as a Special Review, which is a detailed assessment of the costs and benefits associated with the registered uses of a pesticide.
    On May 22, 1990, the petitioners filed objections to EPA's response. Again, the petitioners' central objection was that EPA had incorrectly interpreted section 409 by reading a de minimis exception into the Delaney clause. The petitioners also contended that an ongoing review of a pesticide under FIFRA did not provide grounds for refusing to rule on their petition. Although under the FFDCA the petitioners could have requested an administrative hearing on the petition denial, they specifically asserted that no hearing was necessary since their objections involved strictly legal issues. EPA requested public comments on the petitioners' objections (55 FR 26498, June 28, 1990).
    On February 25, 1991, EPA (1) rejected the petitioners' request to revoke the food additive regulation for trifluralin on spearmint and peppermint oils and for benomyl on raisins and tomato products, finding that these regulations posed a trivial risk, thereby falling within the de minimis exception to the Delaney clause; (2) denied the petitioners' request to revoke the food additive regulations for mancozeb on raisins and bran of barley, oats, rye and wheat pending the ongoing FIFRA Special Review; (3) rejected the request to revoke the phosmet food additive regulation on cottonseed oil noting that it was expecting further data on the carcinogenicity of phosmet; (4) noted that the food additive regulation for chlordimeform on dried prunes had been revoked on October 25, 1989 (54 FR 43424); and (5) stated it would propose to revoke the food additive regulations for dicofol on dried tea and DDVP on packaged and bagged nonperishable processed foods. On October 3, 1991, EPA proposed to revoke the DDVP and dicofol food additive regulations (56 FR 50190). On May 13, 1992, EPA issued an additional order on the California petition addressing the mancozeb food additive regulations because the Special Review of mancozeb had been completed. This order denied the petition as to the mancozeb food additive regulations, finding that each of them posed a de minimis risk (57 FR 20481, May 18, 1992).

D. The Ninth Circuit Decision

    The petitioners challenged EPA's February 25, 1991 Final Order in the U.S. Court of Appeals, Ninth Circuit. On July 8, 1992 , in Les v. Reilly, 968 F.2d 985 (9th Cir.), the court overturned EPA's interpretation that the Delaney clause contains an exception for pesticide uses that present no more than a de minimis cancer risk. The court ruled that food additive regulations are barred for any pesticides that are animal or human carcinogens. Although the court's ruling immediately affects only the pesticides involved in the petition, under the court's interpretation of the Delaney clause, food additive regulations will have to be revoked or denied for dozens of pesticide uses that either have or need such regulations.
    EPA disagrees with the Ninth Circuit's decision and continues to believe that a de minimis exception is appropriate both as a legal matter and as a matter of public policy. EPA asked the Department of Justice (DOJ) to petition the Supreme Court for a writ of certiorari on behalf of EPA. The Solicitor General in DOJ makes decisions concerning whether cases involving Federal agencies will be appealed to the Supreme Court. The Solicitor General ultimately decided against petitioning the Supreme Court to review this case. The Solicitor General concluded that this case was not one of the small number of Federal cases, from among many presented each year for possible Supreme Court action, that merited a petition for certiorari.
    The National Agricultural Chemicals Association (NACA), which intervened in the case supporting EPA's position, has filed a petition with the Supreme Court for a writ of certiorari asking the Supreme Court to overturn the Circuit Court's decision. For the moment, the effect of the Ninth Circuit's decision has been stayed by the filing of NACA's petition with the Supreme Court. EPA does not know when the Supreme Court will rule on NACA's petition. If the Supreme Court does not agree to hear NACA's petition, or uphold's the Ninth Circuit's decision, EPA will be required to revoke the tolerances that were the subject of the California petition. EPA is prepared to act promptly after any adverse Supreme Court action.

E. Other Judicial Action Involving the Delaney Clause

    The same parties which petitioned EPA to revoke several existing 409 tolerances as violative of the Delaney clause have also filed suit seeking to compel EPA action on data showing that various pesticides concentrate during processing on certain foods. The plaintiffs contend that the FFDCA, and specifically the Delaney clause, requires EPA to revoke section 408 tolerances for all pesticide uses for which processing studies show concentration in a processed food form. The plaintiffs are seeking an injunction from the court ordering EPA to take prompt action to revoke all affected 408 tolerances. At present, the Court is considering motions by both the plaintiffs and EPA that the case should be decided without a trial, based on each side's legal arguments.

II. NFPA Petition

    On September 11, 1992, several groups representing pesticide users and food processors (National Food Processors Association (NFPA), the United Fresh Fruit and Vegetable Association, the Florida Fruit and Vegetable Association, the Northwest Horticultural Council and the Western Growers Association) filed a petition (hereafter referred to as the ``NFPA petition'') with EPA requesting that section 408 tolerances remain effective for pesticides when, under the Les decision, the associated section 409 tolerances could not be established or would be revoked because the pesticides to which the tolerances relate induce cancer in animals or man. The NFPA petition characterizes EPA's coordination policy as the ``EPA concentration policy.'' The ``Summary and Conclusions'' section of the petition, which summarizes its contents, is quoted below. (A full copy of the petition and its attachments are available as described in the ADDRESSES section of this document.)

     A. The EPA Concentration Policy is Unlawful

    1. The EPA policy is in direct conflict with the contemporaneous and consistent construction of the 1958 food additive amendments by the Federal Food and Drug Administration (FDA), which was closely involved in the drafting and Congressional consideration of the amendments and which was responsible for administering sections 408 and 409 from 1958 until 1970. Moreover, because the EPA consistently relies on its extra statutory concentration policy as a basis for denying or revoking section 408 tolerances, the policy is in effect an unlawful substantive regulation that has never been proposed for public comment or published as a rule in the Code of Federal Regulations.
    2. The EPA policy unlawfully incorporates the Delaney Clause of section 409 into section 408 for commodities that may concentrate during processing. EPA's risk assessment procedures under the general safety provision of section 408 should govern the determination of whether a pesticide can be approved for use on an agricultural crop, regardless of whether processing of the commodity may result in some concentration.
    3. The EPA policy unlawfully disregards the requirement in section 408 that it ``give appropriate consideration * * * to the necessity for the production of an adequate, wholesome and economical food supply,'' since the policy automatically results in the denial or revocation of section 408 tolerances for some pesticides that are important in the production of food and that satisfy the safety standards of section 408.
    4. The EPA concentration policy unlawfully ignores the language and intent of the flow-through provision of section 402(a)(2)(C). The Agency policy totally disregards the explicit Congressional directive that a pesticide residue in a processed food is lawful under the flow through provision if the level of the ``residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity'' (emphasis added).

    B. The EPA Concentration Policy is Not Necessary to Protect the Public Health or to Avoid Uncertainty in the Marketplace 
    1. Because raw product pesticide tolerances that are subject to revocation on the basis of the EPA concentration policy have previously been found to satisfy the safety standard of section 408, the policy cannot be justified on public health or safety grounds.
    2. FDA and industry pesticide residue data demonstrate that actual residue levels in agricultural commodities and in processed foods are well below section 408 tolerances. As recognized in the language of the flow-through provision itself, pesticide residues are typically reduced during shipment, handling, cleaning and processing of agricultural commodities.
    3. EPA's sole publicly stated justification for its concentration policy is that growers and processors would be unsure which pesticides to use and which crops to purchase, since some raw products containing lawful residues might concentrate on processing and the residue in the processed product might exceed the raw product tolerance. Actual experience demonstrates, however, that growers and processors take great care to maintain pesticide residues at the lowest feasible levels, and that processors can and will produce finished products that are in full compliance with section 402(a)(2)(C).

    C. The EPA Concentration Policy is Contrary to the Public Interest

    1. The EPA policy will force the Agency to prohibit the use on food of beneficial pesticides that pose trivial risks, encouraging the use of alternatives that may be more harmful.
    2. The EPA policy will compel the Agency to prohibit the use on food of numerous valuable and safe pesticides, thereby reducing the availability and increasing the cost to consumers of nutritious fruit, vegetable, and grain products. Continued adherence to the EPA policy is likely to have a particularly adverse impact on minor crops for which relatively few effective pesticides are registered.

III. Issues Raised in the NFPA Petition

    If the Les decision stands, EPA will begin taking action to comply with the Ninth Circuit's decision. The NFPA petition raises several issues EPA should consider when determining which pesticide uses are subject to the Delaney clause. EPA believes that public comment on these issues, which are summarized below, will be beneficial. Therefore, EPA is soliciting comments on the issues raised in or by the NFPA petition.

A. EPA's Coordination Policy

    Several issues under consideration arise from or are related to EPA's policy for coordinating FFDCA sections 408 and 409 (``coordination policy''). Under current policy, where data show that a section 409 food additive regulation is required but cannot be established, or that an existing section 409 tolerance must be revoked, EPA has generally not granted the section 408 tolerance for the associated raw agricultural commodity. Permitting the use of a pesticide where subsequent processing may yield a food with residues above the 408 tolerance, but where no food additive regulation has been established, could produce food that is adulterated. Continuing this policy in light of the Les decision may lead to the revocation of the section 408 tolerances associated with the affected food additive regulations. EPA is seeking comment on what relationship, if any, should be maintained between section 408 and 409 approvals and what goals EPA should pursue with such a policy. In particular, EPA is interested in receiving comments on whether EPA's current policy (if maintained) should be modified to allow 408 tolerances when for example, (1) treated raw agricultural commodities could be segregated and sent to the fresh market; (2) significant economic impacts on pesticide users and consumers would result if the 408 tolerances were revoked; or (3) the risks from residues on the raw commodities would be very small.

B. Concentration of Residues

    EPA's current policy is that a section 409 food additive regulation is needed when there is a possibility that the processing of a raw food containing pesticide residues would result in residues in the processed food at a level greater than the raw food tolerance. If residues in the raw commodity are at or near the tolerance level, there is a possibility of over-tolerance residues in processed food where a processing study shows that concentration of residues occurs through the processing of raw agricultural commodities. Each decision on whether concentration occurs is based on a careful review of scientific data from a processing study. In evaluating whether a processing study shows concentration of residues in the processed food, EPA considers such factors as: (1) the variability in the residue data; and (2) the variability in the analytical method. In the past, taking these factors into account, EPA has concluded in some cases that concentration in the range of 10% requires a section 409 food additive regulation.
    EPA solicits comment on its policy regarding when a food additive regulation is needed. Additionally, EPA solicits comment on whether there are additional or different factors it should consider in determining whether, upon processing, there is a possibility of residues exceeding the raw food tolerance.

C. ``Ready-to-Eat'' Classification

    Enforcement of a section 409 tolerance for pesticide residues carried over from a raw commodity into a processed food is directed to food which is considered ``ready-to-eat.'' [See paragraph A.4. of the NFPA petition summary in Unit II of this document.] Section 402(a)(2)(C) provides that a section 409 tolerance is not necessary when the concentration of a pesticide in a processed food when ready to eat is not greater than the associated section 408 tolerance. The Agency has not previously issued guidance on what constitutes a ``ready-to-eat'' processed food. EPA's general approach to that phrase has been that ``ready-to-eat'' food is processed food or feed available to the consumer or food processor. EPA has not interpreted the phrase ``ready-to-eat'' to mean necessarily ready for immediate consumption without any further mixing, cooking, or other preparation by the consumer. Thus, EPA has set food additive regulations for foods such as flour and tomato paste as well as for apple juice and potato chips. In setting food additive regulations on such commodities as flour and tomato paste, EPA has not considered whether the residue level of the pesticide in, for example, pizza, breads, cakes, or spaghetti sauce is likely to be greater than the corresponding raw food tolerances. EPA requests comment on this policy.
    EPA requests that if any commenter advocates a narrow interpretation of the phrase ``ready-to-eat'' which excludes certain processed food forms, the commenter also address the feasibility of implementing such an interpretation for foods deemed not ``ready-to-eat.'' The comment should address the consequences both for EPA in establishing tolerances and for FDA and USDA in enforcing the FFDCA.

D. Cancelling Affected FIFRA Registrations

    Just as EPA attempts to coordinate its regulatory decisions under sections 408 and 409 of the FFDCA, EPA also attempts to coordinate its regulatory actions under FIFRA and the FFDCA; therefore, EPA does not permit registration under FIFRA of a pesticide whose use would result in adulterated food (40 CFR 152.112(g)). Under this coordination policy, as currently implemented, EPA does not register FIFRA uses or set section 408 tolerances where section 409 food additive regulations are needed for a pesticide use but cannot be established. Therefore, current policy dictates that generally, when a section 409 tolerance must be revoked, EPA should not only revoke the associated section 408 tolerance, but it should cancel the FIFRA registration for that use as well. Although not explicitly mentioned in the NFPA petition, this issue is related to the policies EPA must consider when determining what regulatory actions to take with respect to what pesticide uses affected by the Ninth Circuit's decision. EPA requests comment on this aspect of its policy. In particular, if commenters support continuing registrations and section 408 tolerances for pesticides that need section 409 tolerances, but are barred by the Delaney clause, EPA requests comments on whether, and what type of, warning statements would be appropriate on pesticide labels for affected uses.

IV. Related Issues for EPA Consideration in Future Regulation of Residues in Raw and Processed Foods

    In addition to the issues specifically raised in or by the NFPA petition, there are other issues EPA must consider when determining which pesticides will be affected by the Les decision. EPA has outlined those issues below for the purpose of soliciting public comment. If the Les decision is upheld, these issues will assume greater significance in EPA's regulation of pesticide residues.

A. The DES Proviso

    The Delaney clause contains an exception to the prohibition of additives found to induce cancer for substances used: as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations * * *) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal. (21 U.S.C. 1348(c)(3)).
    This provision is commonly referred to as the DES proviso because it was adopted in response to the use of the animal drug diethylstilbestrol (DES). FDA interprets the ``no residue'' language in the DES proviso to mean residues of the pesticide in the food which pose an upper-bound lifetime cancer risk of 1 in 1 million or less. 21 CFR 500.84. FDA's interpretation is not based on a de minimis interpretation, but on the principle of statutory construction that every provision of a statute must be given an effect. See 52 FR 49572. A literal application of the ``no residue'' requirement would, as a practical matter, make the DES proviso inoperable because given the increased sophistication of analytical methods, FDA has been unable to conclude that no trace of any given substance will remain in edible products. Id.
    EPA solicits comment on the application of the DES proviso to pesticide residues in animal feeds, particularly in light of the Les decision.

B. Constituents Policy

    Both EPA and FDA interpret the term ``additive'' in the Delaney clause to refer to the added substance as a whole and not to contaminants or impurities in the substance. Thus, if a constituent of a food additive such as a contaminant or impurity has been found to induce cancer, but the parent additive has not, the FDA and EPA have not invoked the Delaney clause, but rather have evaluated the parent (including risk from the constituents) under the general safety clause of the FFDCA. EPA does not regard deliberately added active or inert ingredients, and/or metabolites thereof, as candidates for consideration under the constituents policy, rather, EPA regards these substances as subject to the Delaney clause. EPA solicits comment on this interpretation of the term ``additive'' in the Delaney clause.

C. Section 18 Emergency Exemptions

    Section 18 of FIFRA permits EPA to exempt State governments or Federal agencies from the requirements of FIFRA when EPA determines that an emergency situation exists and that the emergency use of the pesticide will not result in unreasonable adverse effects to the environment. The section 18 regulations require that, in deciding whether to issue an emergency exemption, EPA give ``due consideration * * * to the progress which has been made toward registration of the proposed use, if a repeated specific or public health exemption is sought'' (40 CFR 166.25(b)(2)). Because of EPA's coordination policy, whereby EPA will not register a use or establish a section 408 tolerance if concentration during processing indicates that a section 409 tolerance is required, but prohibited by Delaney, EPA could not make the finding of sufficient progress toward registration in cases where a food additive regulation is needed, but would be barred by the Delaney clause. If the Les decision is upheld, EPA will alert appropriate State and Federal agencies that EPA may not grant exemptions for uses that trigger Delaney clause concerns.
    EPA seeks comment on this issue and on the impact of the potential elimination of the de minimis policy and retention of the coordination policy on the Agency's granting of FIFRA section 18 exemptions.

D. Regulatory Impacts

    EPA is required under Executive Order 12291 to assess the benefits and costs to society which would result from revocation of tolerances affected by the court's decision, as well as from other regulatory actions which these revocations may trigger under current EPA policy. EPA has not undertaken a systematic assessment of the costs and benefits under EPA's policy, or the impacts associated with the policy changes suggested in the NFPA petition. While the degree of disruption will depend on which policies EPA ultimately uses, preliminary analyses suggest that section 409 tolerance revocations, coupled with current EPA policy, would significantly affect production of some agricultural commodities. These impacts may result in income loss to users, a reduction in the quality and quantity of affected crops, and increases in consumer prices. In many instances, impacts are expected to be concentrated in different geographic regions as affected by each region's degree of dependence on specific pesticides. There is also the possibility that some alternatives to affected pesticides may pose higher human (non-cancer) or environmental risks than the risks posed by the affected pesticides.
    The Agency will conduct an assessment of the costs and benefits to society as a part of any regulatory action involving the Delaney clause and EPA's coordination policy. EPA has identified information, which is presented below, it believes would be useful to conduct this assessment. EPA requests comments on whether and what types of additional information would be useful to fully assess the costs and benefits of revoking affected tolerances.
    Specifically, EPA believes information would be useful regarding the nature and extent of use (namely percent of crop treated, number of acre treatments applied annually, typical rate of application, and time of application) of pesticides and uses affected by the Delaney clause, pests controlled, likely alternative chemical and non-chemical controls, relative efficacy or performance of alternatives, the economic impacts to different sectors of the economy ( e.g. crop producers, food processors and final consumers), and the impacts on imports and foreign competition which would result from the revocation of tolerances and food additive regulations on affected commodities and processed food products. EPA will also find its useful to consider the comparative risks of likely alternatives to affected pesticides. EPA will also consider information on the percent of each affected processed food product which has pesticide residues above the current associated section 408 tolerance, as well as information on the number of current users who would be affected if only section 409 tolerances were revoked.
    Information on the timing of issuing tolerance revocations and effective dates would be useful in conducting the regulatory impact assessments once a decision to revoke is announced. EPA would find useful information, by both commodity and processed food, on the time of year for both pesticide use and crop harvest, the timing of processing in relation to harvest, and the length of time following harvest for both the raw agricultural commodities and different processed food products to clear domestic channels of trade. EPA will conduct an assessment using both typical and worst case estimates, as well as consideration of regional impacts. This latter information will be helpful to EPA in assessing the impact to growers who use the pesticides prior to the revocation and in analyzing the extent of any dislocation resulting from the revocations.

E. Determining the Level for Section 408 Tolerances

    As noted in Unit I of this notice, EPA sets section 408 tolerances based on the highest levels observed in controlled field trials. EPA's current policy is to include all data points reflecting the maximum application rate and minimum preharvest interval allowed on the label since crops could be legally treated in this manner. This tolerance setting procedure reduces the chances of a crop treated according to label directions having illegal residues. On some occasions, EPA has discarded one or more of the higher residue values in a particular set of data when there is evidence of extremely unusual weather conditions, misapplication of the pesticide, or the possibility of samples being switched after harvest. It is relatively rare that such discarding occurs when EPA establishes tolerances. On the other hand, international organizations such as the Codex Alimentarius often discard higher residue values such that their maximum residue limits (MRL's) tend to be lower than U.S. tolerances. EPA's approach has thus been occasionally criticized as producing section 408 tolerances that are unnecessarily high.
    If EPA were to change its current policy and exclude these high residue values, EPA would sometimes set lower tolerances. As a consequence, residues would more often exceed tolerance levels in both raw and processed foods. However, it should be noted that there are other factors which more frequently account for the U.S. tolerances being higher than Codex MRL's. For example, the use patterns of the pesticide often differ in the United States and EPA includes residues of metabolites in tolerances more often than the international organizations.
    EPA requests comments on the present policy used to establish section 408 tolerances. In particular, the Agency asks commenters to address the relationship between EPA's use of high residue values in setting section 408 tolerances and policies regarding when there is sufficient concentration of residues during processing to require a section 409 tolerance. Finally, EPA asks that comments address the advantages and disadvantages of changing the current policy on high residue values to follow more closely the approach used by the Codex Alimetarius.

V. Conclusion

    The issues described above are among the considerations raised by the Ninth Ciruit's ruling on the Delaney clause and the NFPA petition. If the Les decision is upheld, EPA may solicit further comment on these issues, as well as other issues which are raised by the conflicts in the legislative scheme governing pesticides. In view of the complexity, interrelatedness, and number of the considerations arising from Les, and the NFPA petition, however, EPA believes these matters to be of sufficient public concern that EPA should begin soliciting comment at this time. EPA is not including a list of potentially affected pesticides in this notice. Instead, EPA expects to release a list of potentially affected pesticides at a later date, either prior to or as part of future regulatory actions. The Agency will consider public comment submitted in response to this notice in focusing and refining its discussion in future notices or actions involving the Delaney clause.

    Dated: January 19, 1993.

William K. Reilly,
Administrator.

[FR Doc. 93 - 2701 Filed 2 - 4 - 93; 8:45 am]
BILLING CODE 6560 - 50 - F