[Federal Register Volume 59, Number 201 (Wednesday, October 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25921]
[[Page Unknown]]
[Federal Register: October 19, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300358; FRL-4909-6]
Dimethipin; Request for Comment on Petition To Revoke Certain
Feed Additive Regulation
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, a petition proposing the revocation of the section 409 feed
additive regulation established under the Federal Food, Drug and
Cosmetic Act (FFDCA) for dimethipin on cottonseed hulls. This notice
sets forth the basis for the petitioner's proposal and provides
opportunity for public comment.
DATES: Written comments, identified by the document control number
[OPP-300358], must be received on or before November 18, 1994.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 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 (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA, 703-305-5805. In person, bring comments to: Rm.
1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Information submitted and any comment(s) 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(s) 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 to the submitter. All written comments will be
available for public inspection at the address and hours given above.
FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi, Special
Review and Reregistration Division (7508W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. WF32C5, CS #1, 1921
Jefferson Davis Hwy., Arlington, VA, (703)-308-8028.
SUPPLEMENTARY INFORMATION:
I. Introduction
Statutory Framework
Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) (21
U.S.C. 346a) authorizes establishment of tolerances and exemptions from
tolerances for the residues of pesticides in or on raw agricultural
commodities (RAC's), and section 409 of the act authorizes promulgation
of food additive regulations for pesticide residues in processed foods
(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 402 of the act. Section 409 food/feed
additive regulations are required, however, only for certain pesticide
residues in processed food. Under section 409(a)(2) of the FFDCA, no
section 409 food/feed additive regulation is required if any pesticide
residues 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 that 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 food
additive regulation is only necessary to prevent foods from being
deemed adulterated when despite the use of good manufacturing practices
the concentration of the pesticide residues 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).
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 tolerances and section 409 food/feed
additive regulations, 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 food additive
regulation 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. Petition
Uniroyal Chemical Co. has submitted a petition requesting the
revocation of the feed additive regulation established under section
409 of the FFDCA for dimethipin on cottonseed hulls. The following
provides background information and sets forth the basis for the
petitioner's request.
The section 408 tolerance for dimethipin on cottonseed is
established at 0.5 part per million (ppm) (40 CFR 180.406). The section
409 feed additive regulation on cottonseed hulls has been established
at 0.7 ppm (40 CFR 186.2050). In a peer review of dimethipin, dated
January 5, 1990, EPA classified dimethipin as a Group C (possible
human) carcinogen.
Dimethipin is the active ingredient in Harvade harvest growth
regulants registered by Uniroyal. Uniroyal claims that since Harvade is
applied to cotton 7 to 14 days before anticipated harvest, a high
percentage of the chemical is deposited on the cotton leaf which
subsequently abscises and drops to the soil surface.
Uniroyal Chemical is requesting revocation of the section 409 feed
additive regulation for cottonseed hulls because, they claim, that it
is not needed and that revoking it will avoid any inconsistency with
the Delaney Clause in section 409 of the FFDCA. According to Uniroyal,
concentration of dimethipin in cottonseed hulls does not exceed the
section 408 tolerance for cottonseed.
To support the assertion that there is no concentration in the
processed commodity, the Petitioner references a processing study [MRID
No. 42920902], which was submitted as a requirement of reregistration
of dimethipin. Uniroyal claims that this work demonstrates that
dimethipin residues do not concentrate in cottonseed hulls (a processed
commodity) when compared with those in ginned cottonseed (a raw
agricultural commodity) (MRID No. 42467001 and 42920901). The study
results are summarized below.
In this new processed fraction study, maturing cotton was treated
with an exaggerated (2X) rate, resulting in an average cottonseed
residue of 0.563 ppm. Values for cottonseed hulls averaged 0.451 ppm.
Only one out of four of the individual sample concentration factors
(values for which are -41%, -30%, -5%, and +7%) suggest a small
possibility of concentration. The mean factor of -17% indicates a net
dilution of nearly one-sixth in generating cottonseed hulls from raw
cottonseed. Uniroyal declares that since the 2X rate produced no
residue in hulls higher than 0.53 ppm, treatment at the full labeled 1X
rate will not have a reasonable probability of producing residues in
cottonseed hulls higher than the RAC tolerance of 0.5 ppm.
Uniroyal submitted a critique of two previous studies addressing
the magnitude of dimethipin residues in cottonseed and processed
fractions. Uniroyal claims that the new study is better documented and
more representative of real-world conditions. In light of new data, the
Petitioner urges EPA to reconsider whether a section 409 feed additive
regulation is necessary for dimethipin in cottonseed hulls.
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, any 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 the date of publication of the
order (40 CFR 178.20).
Authority: 21 U.S.C. 346a and 348.
Dated: September 30, 1994.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 94-25921 Filed 10-18-94; 8:45 am]
BILLING CODE 6560-50-F
