[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Notices]
[Pages 19587-19588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9061]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300381; FRL-4944-1]


Propargite; Request for Comment on Petition to Revoke Certain 
Feed Additive Regulations

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 comments 
on a petition proposing the revocation of the section 409 feed additive 
regulation established under the Federal Food, Drug and Cosmetic Act 
(FFDCA, 21 U.S.C. 348a), for propargite on dried apple pomace. This 
notice sets forth the basis for the petitioner's proposal and provides 
opportunity for comment by the public.

DATES: Written comments, identified by the document control number 
[OPP-300381], must be received on or before May 19, 1995.

ADDRESSES: By mail, requests for copies of the petition and comments 
should be forwarded to Public Response and Program Resources Branch, 
Field Operations Division (7506C), 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 (7502C), 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 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 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 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, Crystal 
Station #1, 2800 Crystal Drive, Arlington, VA, Telephone: 703-308-8028; 
e-mail: Nazmi.N[email protected].

SUPPLEMENTARY INFORMATION:

Introduction

A. 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 (RAC's), and section 409 of the act authorizes promulgation 
of food additive regulations for pesticide residues in processed foods.
    Under section 408, 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. Section 409 food additive regulations are required, 
however, only for certain pesticide residues in processed food. Under 
section 402(a)(2) of the FFDCA, no section 409 food additive regulation 
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 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 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 tolerances and section 409 food 
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. Petitions

    Uniroyal Chemical Co. has submitted a petition requesting the 
revocation of the feed additive regulation (FAR) established under 
section 409 of the FFDCA for propargite on dried apple pomace. This 
regulation is codified in 40 CFR 186.5000 and is established at 80 
parts per million (ppm). [[Page 19588]] 
    In June 1994, EPA updated Table II of the Pesticide Assessment 
Guidelines, Subdivision O, Residue Chemistry. Table II provides a 
listing of all significant food and feed commodities, both raw and 
processed, for which residue data are collected and tolerances or FARs 
are established. The Agency requires data for only those feed items 
considered to be ``significant.'' Feed items are considered to be 
``significant'' if (1) the U.S. annual production of the crop is 
greater than 500 million pounds and the maximum amount in the livestock 
diet is greater than 10 percent; or (2) the commodity is grown mainly 
as a livestock feed. Based on the above criteria, the Agency has 
determined that dried apple pomace is not a significant feed item and 
has removed it from Table II.
    The Petitioner requests that the Agency revoke the section 409 FAR 
for this feed item because it is no longer necessary.
    It should be noted that in the Federal Register of July 1, 1994 (59 
FR 33941), EPA issued a proposed rule to revoke the section 409 food 
additive regulations for propargite because the Agency has determined 
that propargite induces cancer in animals. Thus, the regulation 
violates the Delaney clause in section 409 of the FFDCA. The Agency has 
not yet proposed similar action for the feed additive regulation for 
propargite on dried apple pomace. If this petition is granted, dried 
apple pomace will be removed from the list of pesticides that violate 
the Delaney clause and no further action will be required under section 
408 of the FFDCA for the raw agricultural commodity apples.
    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 date of the publication of the 
order (40 CFR 178.20).

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Feed additives, Food additives, Pesticides 
and pests, Reporting and recordkeeping.

    Dated: April 3, 1995.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

[FR Doc. 95-9061 Filed 4-18-95; 8:45 am]
BILLING CODE 6560-50-F