EBDCs (General Information) Petition To Revoke Certain Food Additive Regulations 5/93
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,
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,
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.
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.
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.
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
[FR Doc. 93-11874; Filed 5-18-93; 8:45 am]
BILLING CODE 6560-50-F