propargite (Omite, Comite) Receipt of Proposed Revocation Petition 8/94
Propargite; Request for Comment on Petition to Revoke Certain
Food Additive Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice; receipt and availability of petition.
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,
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.
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.
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
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
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]