[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