96-13823. Iprodione; Request for Comment on Petition to Revoke Food Additive Regulations for Raisins and Dried Ginseng

[Federal Register Volume 61, Number 109 (Wednesday, June 5, 1996)]
[Notices]
[Pages 28578-28580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13823]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300427; FRL-5374-8]


Iprodione; Request for Comment on Petition to Revoke Food 
Additive Regulations for Raisins and Dried Ginseng

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 iprodione in or on raisins and dried ginseng. 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 [OPP-300427] 
must be received on or before July 5, 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 in the public docket from 8 a.m. to 
4:30 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: [e-mail]. 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

[[Page 28579]]

[OPP-300427]. 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: [phone], 
e-mail: [e-mail].
SUPPLEMENTARY INFORMATION:

I. Introduction

    The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et 
seq., authorizes the establishment by regulation of maximum permissible 
levels of pesticides in foods. Such regulations are commonly referred 
to as ``tolerances.'' Without such a tolerance or an exemption from the 
requirement of a tolerance, a food containing a pesticide residue is 
``adulterated'' under section 402 of the FFDCA and may not be legally 
moved in interstate commerce. 21 U.S.C. 331, 342. EPA was authorized to 
establish pesticide tolerances under Reorganization Plan No. 3 of 1970. 
5 U.S.C. App. at 1343 (1988). Monitoring and enforcement of pesticide 
tolerances are carried out by the U.S. Food and Drug Administration 
(FDA) and the U.S. Department of Agriculture (USDA). EPA can establish 
a tolerance in response to a petition (FFDCA section 408(d)(1), 
409(b)(1)), or on its own initiative (FFDCA sections 408(e), 409(d)).
    The FFDCA has separate provisions for tolerances for pesticide 
residues on raw agricultural commodities (RACs) and tolerances on 
processed food. For pesticide residues in or on RACs, EPA establishes 
tolerances, or exemptions from tolerances when appropriate, under FFDCA 
section 408. 21 U.S.C. 346a. EPA regulates pesticide residues in 
processed foods under FFDCA section 409, which pertains to ``food 
additives.'' 21 U.S.C. 348. Maximum residue regulations established 
under section 409 are commonly referred to as food additive regulations 
(hereafter referred to as ``FARs''). Section 409 FARs are needed, 
however, only for certain pesticide residues in processed food. Under 
section 402(a)(2) of the FFDCA, a pesticide residue in processed food 
generally will not render the food adulterated if the residue results 
from application of the pesticide to a RAC and the residue in the 
processed food when ready to eat is below the RAC tolerance. 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 the processed food forms. Thus, a section 
409 FAR is only necessary to prevent foods from being deemed 
adulterated when the level of the pesticide residue in a processed food 
when ready to eat is greater than the tolerance prescribed for the RAC, 
or if the processed food itself is treated or comes in contact with a 
pesticide. If a FAR must be established, section 409 of the FFDCA 
requires that the use of the pesticide will be ``safe'' (21 U.S.C. 
348(c)(3)). Relevant factors in this safety determination include (1) 
the probable consumption of the pesticide or its metabolites; (2) the 
cumulative effect of the pesticide in the diet of man or animals, 
taking into account any related substances in the diet; and (3) 
appropriate safety factors to relate the animal data to the human risk 
evaluation. Section 409 also contains the Delaney clause, which 
specifically provides that ``no additive shall be deemed safe if it has 
been found, after tests which are appropriate for the evaluation of the 
safety of food additives, to induce cancer when ingested by man or 
animal.''
    FARs are currently established in 40 CFR 185.3750 for iprodione in 
or on dried ginseng and raisin.

II. Petition

A. Raisins

    Rhone-Poulenc is proposing labeling restrictions which would 
prohibit the use of iprodione products on grapes used to produce 
raisins. The Petitioner believes that enforcement of the label 
restriction is possible because: (1) Early in the growing season, 
several cultural practices differentiate grapes grown for raisin 
production from those grown for table or wine grape; and 2) raisins are 
the only commodity produced from raisin grapes and introduced into 
commerce. Rhone-Poulenc contends that a less elaborate trellis system 
is used for raisin grapes than for table grapes. In addition, raisin 
grapes are not irrigated after early August whereas the table and wine 
grapes require irrigation late into the season. Furthermore, producers 
growing grapes for table use tend to use gibberellin early in the 
season to increase size which makes those grapes undesirable as 
raisins. Rhone-Poulenc also claims that all raisins are sold under a 
contract with a buyer, prior to the beginning of the growing season. 
Therefore, grapes intended to be grown for table use or wine production 
would never be sold as raisins.
    To ensure compliance with the proposed label restriction, Rhone-
Poulenc commits to conducting an industry educational program. This 
effort would be in California which is the only state where raisins are 
commercially produced. The program would target the Licensed Pest 
Control Advisors (PCA), reseller, County Agricultural Commissioner, and 
raisin buyers to inform them of the label restriction.
    Rhone-Poulenc proposes to:
    (1) Develop a direct mail notice to the PCAs in the predominant 
raisin growing counties of Fresno, Tulare, and Madera, in California.
    (2) Develop a product bulletin for Rhone-Poulenc's sales associates 
to distribute to resellers and County Agricultural Commissioners.
    (3) Place the label restriction in the Crop Data Management System 
(CDMS). The Petitioner claims that 80 to 90 percent of the 
recommendations written by a PCA are generated by computer through 
CDMS.
    (4) Communicate in person with the management of raisin buying 
companies such as SunMaid. Rhone-Poulenc will attempt to have these 
companies put in writing, that they will not accept any raisins treated 
with iprodione products.

B. Dried Ginseng

    The petitioner claims that ginseng is not a ready-to-eat commodity 
because of the significant amount of dilution of dried ginseng in 
preparation of a ready-to-eat food. According to Rhone-Poulenc, once 
dried ginseng is in its ready-to-eat form, residues are unlikely to 
exceed the RAC tolerance.
    EPA isvites comment on the petition to withdraw the food additive 
regulation for raisins and dried ginseng.
    It should be noted that on January 18, 1995, EPA published a 
proposed rule in the Federal Register to revoke the section 409 FAR for 
iprodione in or on dried ginseng and raisins. That proposal was based 
on a determination that iprodione 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 dried ginseng and 
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

[[Page 28580]]

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 
[OPP-300427] (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.
    Electronic comments can be sent directly to EPA at:
    [e-mail]


     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: May 23, 1996.

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

[FR Doc. 96-13823 Filed 6-4-96; 8:45 am]
BILLING CODE 6560-50-F