[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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