[Federal Register Volume 61, Number 21 (Wednesday, January 31, 1996)]
[Notices]
[Pages 3401-3403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1904]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-645; FRL-4996-8]
Captan; Request for Comment on Petition to Revoke Food Additive
Regulations for Raisins
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
regulation established under the Federal Food, Drug and Cosmetic Act
(FFDCA), for captan in or on washed raisins. This notice sets forth the
basis for the petitioner's proposal and provides opportunity for
comment by the public.
DATES: Written comments, identified by the docket number [PF-645] must
be received on or before March 1, 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
[[Page 3402]]
Pesticide Programs, 401 M St., SW., Washington, DC 20460. Copies of the
petition will be available for public inspection in the public docket
from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays, in
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. The
telephone number of the docket is 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: opp-docket@epamail.epa.gov. 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 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [PF-645]. No CBI should be submitted through e-mail.
Electronic comments on this document may be filed online at any Federal
Depository Library. Additional information on electronic submissions
can be found below in 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:nazmi.niloufar@epamil.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
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, EPA establishes tolerances, or exemptions from
tolerances when appropriate, for pesticide residues in RACs. Food
additive regulations setting maximum permissible levels of pesticide
residues in processed foods are established under section 409. Section
409 food additive regulations 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 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 residue in a processed food is
greater than the tolerance prescribed for the RAC, 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)]
In setting both section 408 tolerances and section 409 food
additive regulations, EPA reviews residue chemistry and toxicology
data. To be acceptable, tolerances must be able both to cover residues
likely to be left when the pesticide is used in accordance with its
labeling, and to protect the public health. With respect to section 408
tolerances, EPA determines the highest levels of residues that might be
present in a 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 food additive regulation is needed depends on whether there is a
possibility that the processing of a RAC containing pesticide residues
would result in residues in the processed food at a level grater than
the raw food tolerance.
Food additive regulations are currently established in 40 CFR
185.500 for captan on raisins resulting both from its preharvest
application to grapes and from post-harvest application to raisins
during the drying process.
II. Petition
The Captan Task Force and its members, Makhteshim Chemical Works,
Ltd., and ZENECA, Inc., have submitted a petition requesting the
revocation of the food additive regulation established under section
409 of the FFDCA for captan in or on washed raisins. The petition
claims that: good manufacturing practice for producing raisins requires
that the raisins be washed before they are ``ready-to-eat''; washing
raisins substantially eliminates remaining captan residues because
captan is highly susceptible to hydrolytic degradation; and therefore,
captan residues do not concentrate in washed raisins above residue
levels on treated grapes, and do not require a food additive
regulation. The petition also claims that there is no registration for
post-harvest use of captan directly on raisins, and therefore the food
additive regulation covering that application method is unnecessary.
To support these claims, the petition cited the following: A
processing study which was submitted in March, 1987 (MRID No.
40189812); a pamphlet from the California Raisin Advisory Board
describing raisin production practices, which was submitted with this
petition; hydrolysis data which was submitted in May, 1989 (MRID No.
41176301); and labels for Captan 50-WP products.
In regard to washed raisins, the petition claims that the
processing study shows that captan residues do not concentrate in
raisins above the level of the 408 tolerance for captan on grapes,
currently established at 50 ppm (40 CFR 180.103). Therefore, the
petition asserts that the section 409 food additive regulation is not
needed for washed raisins.
In regard to post-harvest application to raisins, the petition
claims that the section 409 food additive regulation is not needed
because there are no registered products containing captan which
include label directions for post-harvest use on raisins. For this
reason, the Petitioner believes that the section 409 food additive
regulation for captan on raisin due to post-harvest application is not
needed.
It should be noted that on July 1, 1994 EPA published a proposed
rule in the Federal Register to revoke the section
[[Page 3403]]
409 food additive regulation for captain in or on raisins (59 FR
33941). That proposal was based on a determination that captan induces
cancer in animals, and thus, the regulation violates the Delaney clause
in section 409 of the FFDCA. However, the Agency could finalize
revocation of the captan raisin regulation on the grounds requested in
the petition announced in this notice.
Pursuant to 40 CFR 177.125 and 177.130, 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 date of the publication of the
order, (40 CFR 178.20).
A record has been established for this document under docket number
[PF-643] (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, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Elecrtronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
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 document, 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.
Dated: January 25, 1996.
Penelope A. Fenner-Crisp,
Acting Director, Office of Pesticide Programs.
[FR Doc. 96-1904 Filed 1-26-96; 2:55 pm]
BILLING CODE 6560-50-M
