[Federal Register Volume 59, Number 239 (Wednesday, December 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30735]
[[Page Unknown]]
[Federal Register: December 14, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300373; FRL-4920-3]
Oxyfluorfen; Request for Comment on Petition To Revoke Certain
Food Additive Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of 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 food
additive regulations established under the Federal Food, Drug and
Cosmetic Act (FFDCA) for the herbicide oxyfluorfen and its metabolites
containing the diphenyl ether linkage (hereinafter oxyfluorfen). 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-300373], must be received on or before January 13, 1995.
ADDRESSES: By mail, requests for copies of the petition and comments
should be forwarded to the 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 in Rm. 1132 at
the Virginia address given above, from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
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 22202, (703-308-8028).
SUPPLEMENTARY INFORMATION:
I. Statutory Framework
The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 136 et
seq.) authorizes under section 408 (21 U.S.C. 346a) the establishent of
tolerances and exemptions from tolerances for the residues of
pesticides in or on raw agricultural commodities (RAC), and section 409
of the act authorizes promulgation of food additive regulations for
pesticide residues in processed foods (21 U.S.C. 348).
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. Section 409 food/feed additive
regulations (FAR) are needed, however, only for certain pesticide
residues in processed food. Under section 402(a)(2) of the FFDCA, no
section 409 FAR is needed 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 FAR 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 into
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)).
In setting both section 408 tolerances and section 409 FAR, 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 FAR 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. Petition
Rohm and Haas Co. has submitted a petition requesting the
revocation of the food additive regulations established under section
409 of the FFDCA for the herbicide oxyfluorfen in or on cottonseed oil,
mint oil, and soybean oil. According to the petition, the oxyfluorfen
FAR for cottonseed oil, mint oil, and soybean oil should be revoked
because residues in the processed oils do not exceed the section 408
tolerance levels for raw commodities.
Rohm and Haas cites the method of application of oxyfluorfen as a
key factor as to why no residues are expected to be present in the
agricultural commodities. Particularly, the petitioner claims that
oxyfluorfen is a nonselective herbicide that destroys plant tissue.
Therefore, oxyfluorfen is not applied to food crops, but is applied
either directly to weeds shortly after they have emerged, or to soil in
order to prevent emergence of weeds. Rohm and Haas has developed and
submitted data to support the assertion that oxyfluorfen does not
translate from the soil into growing plants (MRID Nos. 42913201,
42873301, 42865001, 160143, 00040912, 00040911, 00039926, and
00039925).
The petitioner claims that all processed oil data from field
studies show residue levels below the section 408 tolerance levels,
even when applied at maximum level rates. The petition includes
descriptions of previously submitted field residue data for cottonseed/
cottonseed oil, mint/mint oil, soybean/soybean oil, and some additional
data. These residue data from field trials are on file with the EPA
(MRID Nos. 92136075, 9213081, 92136086).
The petitioner contends that there is further dilution of residues
during processing and before the food containing these commodities is
ready to eat.
Cotton: Although the residue levels in samples from the above
studies are allegedly below the section 408 tolerance levels, Rohm and
Haas claims that the actual processed food, when ready to eat, will
have even lower residues. First, Rohm and Haas asserts that only 4
percent of the cotton grown in the U.S. is treated with oxyfluorfen.
The processing of cottonseed oils occurs at centralized facilities
where cottonseed from different producers is mixed. In addition,
purification of the oil occurs during several stages in order to
transform the crude oil into finished oil. This further processing
would likely remove any oxyfluorfen residues. Finally, the petitioner
contends that further dilution will occur as the cottonseed oil is
incorporated into processed foods before the oil is ready to eat.
Mint: In addition to the claim that residues in the processed mint
oil fraction do not exceed the section 408 mint tolerance, the
petitioner asserts that residue levels in processed food will be much
lower. Rohm and Haas contends that the section 408 tolerance will not
be exceeded.
Soybeans: The petitioner claims that soybean data show residue
levels substantially below the section 408 tolerance. Specifically, 95
percent of the data points are below the detection limit.
Rohm and Haas Co. requests that EPA consider the foregoing
arguments and revoke the section 409 FAR for oxyfluorfen in cottonseed
oil, mint oil, and soybean oil.
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 the publication of the
order (40 CFR 178.20).
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: December 1, 1994.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 94-30735 Filed 12-13-94; 8:45 am]
BILLING CODE 6560-50-F