[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