[Federal Register Volume 60, Number 240 (Thursday, December 14, 1995)]
[Notices]
[Pages 64163-64165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30502]



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ENVIRONMENTAL PROTECTION AGENCY

[OPP-300404; FRL-4986-5]


Benomyl, Propargite, Thiophanate-Methyl, and Triadimefon; Request 
for Comment on Petitions to Revoke Certain Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; Receipt and Availability of Petitions.

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SUMMARY: This document announces the receipt of and solicits comments 
on three petitions. A petition filed by the International Apple 
Institute requests revocation of four section 409 feed additive 
regulations (FARs) established under the Federal Food, Drug and 
Cosmetic Act (FFDCA) for residues of benomyl, propargite, thiophanate-
methyl, and triadimefon in dried apple pomace. A petition filed by 
Janssen Pharmaceutica requests revocation of the food additive 
regulation for residues of imazalil in citrus oil. A petition filed by 
the Mancozeb Task Force requests revocation of the FARs for residues of 
mancozeb in or on milled feed fractions of barley, oats, rye, and 
wheat. This notice sets forth the basis for the petitioners' proposals 
and provides opportunity for public comment.

DATES: Written comments, identified by the document control number 
[OPP-300304], must be received on or before January 16, 1996.

ADDRESSES: By mail, requests for copies of the petition and comments 
should be forwarded to 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 4:30 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 at the address 
and hours given above.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [OPP-300404]. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
notice may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in [OPP-
300304] of this document.

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. Telephone: 703-308-8028; 
e-mail: [email protected].

I. Introduction

Statutory Framework

    The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 136 et 
seq.) authorizes the establishment of tolerances and exemptions from 
tolerances for the residues of pesticides in or on raw agricultural 
commodities (RACs), and section 409 of the Act authorizes promulgation 
of food additive regulations for pesticide residues in processed foods.
    Under section 408 of the FFDCA, EPA establishes tolerances, or 
exemptions from tolerances when appropriate, for pesticide residues in 
raw agricultural commodities. Food/feed additive regulations (FARs) 
setting maximum permissible levels of pesticide residues in processed 
foods are established under section 409. Section 409 FARs are required, 
however, only for certain pesticide residues in processed food. Under 
section 402(a)(2) of the FFDCA, no section 409 food additive regulation 
is required if any pesticide residue in a processed food resulting from 
use on an 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 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 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 

[[Page 64164]]
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 FARs, EPA 
reviews residue chemistry and toxicology data. To be acceptable, 
tolerances and FARs 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 an RAC 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 an RAC containing pesticide residues 
would result in residues in the processed food at a level greater than 
the raw food tolerance. EPA makes these determinations based on 
processing studies.

II. International Apple Institute Petition

    The International Apple Institute (IAI) has submitted a petition 
requesting the revocation of the FAR established under section 409 of 
the FFDCA for residues of benomyl, propargite, thiophanate-methyl, and 
triadimefon in dried apple pomace. The FARs for residues of benomyl, 
propargite, thiophanate-methyl, and triadimefon in dried apple pomace 
are codified in 40 CFR 186.350, 186.5000, 186.5700, and 186.800, 
respectively.

Background

    EPA requires processing data and sets tolerances and FARs only on 
animal feeds that are consumed in significant amounts in the United 
States. Table II of the Pesticide Assessment Guidelines, Subdivision O, 
Residue Chemistry, provides a listing of all significant food and feed 
commodities, both raw and processed, for which residue data are 
collected and tolerances or FARs are established. On September 21, 
1995, EPA announced the availability of the updated Table II and 
modified its guidelines regarding which raw commodities and processing 
byproducts EPA will consider as animal feeds requiring FARs (60 FR 
49150). The general cutoff point used by EPA in deciding which feed 
items are considered ``significant'', is whether the feed item 
constitutes greater than 0.04 percent, by weight, of the total feed 
available to livestock in the U.S.
    Based on the above criteria, the Agency has determined that dried 
apple pomace is not a significant feed item and has removed it from 
Table II. Subsequently, in the Federal Register of September 21, 1995 
(60 FR 49141), EPA issued a proposed rule to revoke the FARs for 
residues of benomyl, propargite, thiophanate-methyl, and triadimefon in 
dried apple pomace.

III. Janssen Pharmaceutica Petition

    Janssen Pharmaceutica is petitioning EPA to revoke the section 409 
FAR for imazalil in citrus oil on the grounds that, in the ready-to-eat 
form, the residue levels are below the section 408 tolerance level 
established for imazalil in the RAC. The Petitioner argues that by the 
virtue of the flow-through provision of section 402(a)(2) of the FFDCA, 
the FAR is unnecessary. The FAR for residues of imazalil in citrus oil 
is codified in 40 CFR 185.3650.
    The Petitioner maintains that citrus oil is used as a flavoring 
agent in minuscule amounts, and if used in excess, it renders food 
unpalatable. Included in the petition is a survey of flavoring 
ingredient usage levels conducted by the Flavoring Extract 
Manufacturers' Association. These values allegedly represent the 
quantity of citrus oil added to food to accomplish its intended 
physical effect. The data presented show that maximum residues of 
imazalil in ready-to-eat foods are below the section 408 tolerance. 
Therefore, Janssen Pharmaceutica argues that the section 409 FAR is not 
needed and should be revoked on the basis that it is not necessary.

Background

    In the Federal Register of January 18, 1995 (60 FR 3607), EPA 
issued a proposed rule to revoke the section 409 FAR for imazalil in 
citrus oil because the Agency has determined that imazalil induces 
cancer in animals and therefore violates the Delaney clause in section 
409 of the FFDCA.
    In the Federal Register of June 14, 1995 (60 FR 31300), EPA issued 
its response to a petition filed by the National Food Processors 
Association that sought the revision of many EPA policies. In that 
notice, EPA announced its revised approach to the term ready-to-eat 
(RTE). EPA believes that a food should be considered ready to eat only 
if it is consumed ``as is'' or added to other ready-to-eat foods.If EPA 
finds that a processed food form is not ready to eat, and once diluted 
to its RTE form the residues are below that of the RAC, then a section 
409 FAR would not be needed and the Delaney clause would not apply. The 
Agency's final rule regarding the residues of imazalil in citrus oil 
will be published by July 1996.

IV. Mancozeb Task Force Petition

    The Mancozeb Task Force (DuPont, Elf Atochem North America, Inc., 
and Rohm & Haas Co.) has submitted a petition requesting the revocation 
of the FARs established under section 409 of the FFDCA for residues of 
mancozeb in or on milled feed fractions of barley, oats, rye, and 
wheat. This FAR is codified in 40 CFR 186.6300.
    As explained in section II above, EPA recently updated Table II of 
the Pesticide Assessment Guidelines, Subdivision O, Residue Chemistry. 
EPA has determined that milled fractions of barley, oats, and rye are 
not significant feed items, and therefore the section 409 FAR is no 
longer necessary. In the Federal Register of September 21, 1995 (60 FR 
4915), EPA issued a proposed rule to revoke the FAR for residues of 
mancozeb on milled fractions of barley, oats, and rye.
    As explained in section III above, on June 14, 1995, EPA announced 
its revised approach to the term ready-to-eat. Based on this policy, 
EPA has determined that milled fractions of wheat is not a ready-to-eat 
feed item, and once diluted, the residues of mancozeb in the RTE animal 
feeds are unlikely to exceed the section 408 tolerance level. 
Therefore, a section 409 FAR is unnecessary. On this basis, in the 
Federal Register of September 21, 1995 (60 FR 49150), EPA revoked the 
section 409 FAR on milled fractions of wheat.
    Pursuant to 40 CFR 177.125 and 177.30, EPA may issue an order 
ruling on the petitions or may issue a proposal in response to the 
petitions and seek further comment. If EPA issues an order in response 
to the petitions, 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 date of the publication of the 
order (40 CFR 178.20).
     A record has been established for this notice under docket number 
[OPP-300404] (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, 

[[Page 64165]]
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this notice, as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: November 13, 1995.

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

[FR Doc. 95-30502 12-11-95; 3:28 pm]
BILLING CODE 6560-50-F