[Federal Register Volume 59, Number 172 (Wednesday, September 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21691]


[[Page Unknown]]

[Federal Register: September 7, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300355; FRL-4905-9]

 

Propargite; Request for Comment on Petition to Revoke Certain 
Food 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 a petition proposing 
the revocation of the section 409 food additive regulations established 
under the Federal Food, Drug and Cosmetic Act (FFDCA) for propargite on 
raisins and dry grape pomace. The petitioner also requests that EPA not 
pursue a section 409 food additive regulation for propargite in raisin 
waste. 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-300355], must be received on or before October 7, 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.
    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 food 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 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)).
    EPA reviews residue chemistry and toxicology data in setting both 
section 408 tolerances and section 409 food additive regulations. 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 food and feed additive regulations established under 
section 409 of the FFDCA for propargite on raisins and dry grape 
pomace. In addition, the petitioner requests that EPA withdraw its 
petition to establish a section 409 food additive regulation for 
propargite in raisin waste. Propargite is the active ingredient in 
Omite miticides registered by Uniroyal. Uniroyal claims that Omite is a 
nonsystemic contact miticide that acts primarily by surface contact and 
that surface residues are susceptible to release through mechanical 
and/or washing processes.
    To support these claims, the Petitioner submitted two studies: A 
propargite Market Basket study, which was submitted on September 15, 
1992, and a processing study submitted with this petition. The petition 
involves raisins, dry grape pomace as animal feed, and raisin waste as 
animal feed. The following sets forth the basis for the petitioner's 
request.
    The Petitioner asserts that the processing study shows that 
propargite residues do not concentrate in raisins. The Petitioner also 
asserts that the processing study supports the results of Uniroyal's 
Market Basket study showing residues of propargite in raisins to be in 
the range of 0.02 to 0.69 part per million (ppm). The section 408 
tolerance for propargite in grapes is currently established at 10 ppm 
(40 CFR 180.259). Therefore, the Petitioner asserts that the section 
409 food additive regulation is not needed at this time.
    In regard to dry grape pomace, again the Petitioner claims that the 
section 409 food additive regulation for dry grape pomace is not needed 
because residues of propargite do not concentrate above the level of 
section 408 tolerance in grapes. Furthermore, Uniroyal contends that 
since dry grape pomace is not ``intended for use as a substantial 
source of nutrients in the diet of the animal,'' it does not meet the 
definition of ``animal feed'' in section 201(x) of the FFDCA. Finally, 
the Petitioner asserts that even if dry grape pomace is used, it would 
be diluted with other food matter and when ``ready to eat'' would not 
exceed the section 408 tolerance for grapes. For these reasons, 
Uniroyal believes that the section 409 food additive regulation for 
propargite on dry grape pomace is not needed. The section 409 food 
additive regulation for propargite on dry grape pomace is 40 ppm (40 
CFR 186.5000).
    In regard to raisin waste, Uniroyal presents two reasons why EPA 
should not pursue a section 409 food additive regulation for propargite 
in raisin waste. First, Uniroyal maintains that residues of propargite 
in raisin waste would not be expected to exceed the section 408 
tolerance in grapes. Second, since raisin waste has low nutritional 
value and is usually discarded, it does not meet the definition of an 
``animal feed'' under FFDCA section 201(x). Therefore, the Petitioner 
requests that EPA not pursue a section 409 food additive regulation for 
propargite on raisin waste.
    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 regulation for propargite in raisins 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 actions for the feed additive 
regulations for propargite.
    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: August 24, 1994.

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

[FR Doc. 94-21691 Filed 9-6-94; 8:45 am]
BILLING CODE 6560-50-F