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propargite (Omite, Comite) Receipt of Proposed Revocation Petition 8/94

[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]