WEDNESDAY
May 19, 1993
Part IV
Environmental Protection Agency
Request for Comment on Petition to Revoke Certain Food Additive Regulations for Benomyl and Mancozeb; Office of Pesticide Programs; 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 29317 - 29319.)
Federal Register / Vol. 58, No. 95 / Wednesday, May 19, 1993 / Notices
ENVIRONMENTAL PROTECTION AGENCY
[OPP - 300285; FRL - 4583 - 2]
Request for Comment on Petition to Revoke Certain Food Additive Regulations for Benomyl and Mancozeb
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice; Receipt and Availability of Petition.
SUMMARY: This document announces the receipt of and solicits comment on two petitions proposing the revocation of certain section 409 food additive tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA). This notice sets forth the basis for the petitioners' proposal and provides opportunity for comment by the public.
DATES: Written comments, identified by the document control number, [OPP-300285], must be received on or before June 18, 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 p.m., Monday through Friday, except legal holidays in: Information Services Branch, Program Management and Support Division (H7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 1132, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-5805.
Information submitted as a comment concerning this notice 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. All written comments will be available for public inspection in Rm. 1128 at the address given above, from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Niloufar Nazmi, Special Review and Reregistration Division (H7508W), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. WF31L1, Crystal Station 1, 2800 Crystal Drive, Arlington, VA 22202, (703)-308-8028.
SUPPLEMENTARY INFORMATION:
Electronic Availability: This document is available as an electronic file on The Federal Bulletin Board at 9 a.m. the day 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 available in Postscript, Wordperfect 5.1, and ASCII.
I. Introduction
Statutory Framework
The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 136 et seq.) authorizes the establishment of tolerances and exemptions from tolerances for the residues of pesticides in or on raw agricultural commodities (RACs) in section 408 of the act, and the promulgation of food additive regulations for pesticide residues in processed foods under section 409 of the act (21 U.S.C. 346(a), 348).
Under section 408 of the act, 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 of the act. 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 RAC has been removed to the extent possible by good manufacturing practices and 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 processed food. Thus, a section 409 tolerance is only necessary to prevent foods from being deemed adulterated when despite the use of good manufacturing practices 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 Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA).
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)).
In setting both section 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. Generally, EPA's policy concerning whether a section 409 tolerance is needed depends 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.
II. Petitions
EPA has received two petitions, from the E.I. du Pont de Nemours & Co. and the Mancozeb Task Force, regarding the revocation of certain tolerances established under section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). Both petitioners claim that no food additive tolerances are necessry for these uses because residues do not concentrate during processing. The following sets forth the basis for the petitioners' requests. (A full copy of the petitions and their attachments, including the referenced studies, is available as described in the ADDRESSES section above in this document.)
E.I. du Pont de Nemours & Co.
E.I. du Pont de Nemours & Co. has submitted a petition requesting revocation of the tolerance established under section 409 of the FFDCA for combined residues of the fungicide benomyl (methyl-1-(butylcarbamoyl)-2-benzimidazolecarbamate) and its metabolites containing the benzimidazole moiety (calculated as benomyl) in concentrated tomato products. The tolerance level for benomyl in concentrated tomato products is 50 parts per million (ppm) (40 CFR 185.350). The tolerance level under section 408 of the FFDCA for tomatoes is 4 ppm (40 CFR 180.294).
According to the petition, benomyl residues are primarily surface residues that wash away during the preparation of tomatoes for processing. The section 409 tolerance was originally set on the basis of a study where tomatoes were not washed, which is not the way tomatoes are actually handled, when being processed into concentrated tomato products. The petition cites recent studies to support the contention that total benomyl residues in concentrated tomato products are below the residues in the RAC. The petition further notes that the FDA/USDA sampling of processed tomato products in 1991 also indicates that no concentration of benomyl residues occurs during processing.
The Mancozeb Task Force, Including E.I. du Pont de Nemours & Co., Elf Atochem North America, Inc., and Rohm and Haas Co.
The Mancozeb Task Force has submitted a petition requesting the revocation of tolerances established under section 409 of the FFDCA for a fungicide which is a coordination product of zinc ion and maneb (manganous ethylene-bisdithiocarbamate, hereinafter referred to as mancozeb) in or on certain processed foods. The processed foods included in this petition are raisins, bran of barley, oats, rye, and wheat, and the flours of barley, oats, rye, and wheat. These tolerances are currently listed in 40 CFR 185.6300. The tolerance levels under section 408 of the FFDCA for grapes and the grains of barley, oats, rye, and wheat are currently listed in 40 CFR 180.176.
The section 409 tolerance for mancozeb on the flours of barley, oats, rye, and wheat is set below the section 408 tolerance for these grains. The lower level for flour was based on FDA's conclusion that good manufacturing practices reduce mancozeb residues in flour (32 FR 7523, May 23, 1967). It should be noted that revoking the section 409 tolerance for mancozeb on flours of barley, oats, rye, and wheat will actually allow a higher level of residues to be legally used on these commodities.
The petition requests revocation of the section 409 tolerance for mancozeb on raisins on the basis of data showing that residues in grapes do not concentrate in raisins. No concentration occurs according to the petition since mancozeb results only in surface residues that wash away during normal handling and processing.
For residues in bran and flour, the petition states that the residues do not concentrate. In support of this position, the petition notes that mancozeb is applied during the early growth stages of wheat, barely, oats, and rye, and that any residues detected in the harvested grain occur from contamination with treated straw or ground. Furthermore, the petition cites submitted data to support the claim that residues in processed grains do not exceed the residues for the grain.
III. Conclusion
EPA has received petitions from E.I. du Pont de Nemours & Co. and the Mancozeb Task Force requesting revocation of certain food additive regulations. The petitioners claim that no section 409 tolerances are necessary for these uses because the residues do not concentrate during processing. EPA announces the receipt of and solicits comment on these two petitions. EPA especially requests comment on the request to revoke the mancozeb tolerances for various flours because the rationale stated in the petition (that residues decrease during processing) was the reason these tolerances were set at a lower level than the section 408 tolerances.
It should be noted that there is currently another petition before EPA requesting the revocation of the benomyl food additive tolerance for concentrated tomato products and the mancozeb food additive tolerances on raisins and bran of wheat. The petition asserts that these food additive tolerances should be revoked because of the Delaney anti-cancer clause in section 409. EPA's earlier order denying that petition as to these tolerances was set aside by the U.S. Court of Appeals, Ninth Circuit, in Les v. Reilly, 968 F. 2d 985 (9th Cir. 1992).
Pursuant to 40 CFR 177.125 and 177.30, EPA may issue an order ruling on the petition or may issue a proposal in response to the petition and seek further comment. If EPA issues an order in response to the petition, a person adversely affected by the order may file written objections and a request for a hearing on those objections with EPA on or before the 30th day after date of the publication of the order. 40 CFR 178.20.
Authority: 7 U.S.C. 346a and 348.
Dated: May 1, 1993.
Lawrence E. Culleen,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 93 - 11874; Filed 5 - 18 - 93; 8:45 am]
BILLING CODE 6560 - 50 - F