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benomyl (Benlate) Petition To Revoke Certain Food Additive Regulations 5/93

[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.
.
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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