[Federal Register Volume 69, Number 82 (Wednesday, April 28, 2004)]
[Proposed Rules]
[Pages 23163-23165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9614]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0091; FRL-6773-2]


Fenpyroximate; Time-Limited Pesticide Tolerance Extension

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes the extension of time-limited 
tolerances for the combined residues of fenpyroximate benzoic acid, 4-
[[[(E)-(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino] 
oxy]methyl]-, 1,1- dimethylethyl ester] and its z-isomer benzoic acid, 
4-[[[[(Z)-(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) 
methylene]aminio]oxy]methyl]-,1,1-dimethylethyl ester)] in or on wine 
grapes and hops under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: Comments must be received on or before June 28, 2004.

ADDRESSES: Submit your comments, identified by Docket ID No. OPP-2004-
0091, by one of the following methods:
    Federal eRulemaking Portal:http://www.regulations.gov. Follow the 
on-line instructions for submitting comments.
    Agency Website: http://www.epa.gov/edocket. EDOCKET, EPA's 
electronic public docket and comment system, is EPA's preferred method 
for receiving comments. Follow the on-line instructions for submitting 
comments.
    Mail: Public Information and Records Integrity Branch (PIRIB), 
Office of Pesticide Programs (OPP), Environmental Protection Agency, 
Mailcode: (7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    Hand Delivery: Public Information and Records Integrity Branch 
(PIRIB), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, Attention: Docket ID number OPP-2004-0091. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805. Such deliveries are only accepted during the Docket's normal 
hours of operation, and special arrangements should be made for 
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. OPP-2004-0091. 
EPA's policy is that all comments received will be included in the 
public docket without change and may be made available online at http://www.epa.gov/edocket, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the federal regulations.gov websites are 
``anonymous access'' systems, which means EPA will not know your 
identity or contact information unless you

[[Page 23164]]

provide it in the body of your comment. If you send an e-mail comment 
directly to EPA without going through EDOCKET or regulations.gov, your 
e-mail address will be automatically captured and included as part of 
the comment that is placed in the public docket and made available on 
the Internet. If you submit an electronic comment, EPA recommends that 
you include your name and other contact information in the body of your 
comment and with any disk or CD ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, 
VA, Monday through Friday, excluding legal holidays. The Docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Melody Banks, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-5413; fax number: (703) 305-6596; e-mail 
address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM 
as CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the rulemaking by docket number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

C. How Can I Access Copies of this Document and Other Related 
Information?

    In addition to using EDOCKET (http://epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available atE-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS Harmonized Guideline referenced in this document, go 
directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

II. Background

    In the Federal Register of February 18, 1999 (64 FR 8090) (FRL-
6059-9), EPA issued a notice of filing under section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 5E4435) by Nichino America, Inc., 4550 New Linden Hill 
Road, Wilmington, DE 19808. The petition requested that 40 CFR 180.566 
be amended by establishing an import tolerance for residues of the 
insecticide fenpyroximate and its z-isomer, in or on grapes and hops 
(green and dried) at 1 parts per million (ppm) and hops at 10 ppm. The 
notice included a summary of the petition prepared by Nichino America, 
Inc., the registrant. There were no comments received in response to 
the notice of filing. On April 10, 2001 (66 FR 18561) (FRL-6773-2), EPA 
issued a final rule under section 408(d)(3) of the FFDCA, 21 U.S.C. 
346a(d)(3), announcing the establishment of time-limited pesticide 
tolerances in conjunction to the original pesticide petition (PP 
5E4435).
    This tolerance was time-limited because the Agency lacked data on 
product chemistry for OPPTS Harmonized Guideline 830.6313, additional 
validation of analytical methods for plants, (multiresidue testing and 
specificity), storage stability studies for grapes and grape juice, 
additional grape field trials in Chile, and additional information on 
uses of fenpyroximate in Mexico. That data has been submitted, and the 
Agency has subsequently determined that the independent lab validation 
method submitted by Nichino America, Inc. needs further clarification. 
Nichino America, Inc. was requested to resubmit this data. All other 
required data identified by the Agency prior to the publication on 
April 10, 2001, of the Final Rule have been submitted to the Agency.

[[Page 23165]]

III. Proposal

    EPA is proposing to extend the dates of expiration for the time-
limited tolerances for residues of the insecticide fenpyroximate and 
its z-isomer, in or on grapes and hops (green and dried) at 1 ppm and 
hops at 10 ppm, from April 14, 2004, to December 31, 2009, to provide 
Nichino America, Inc. additional time to develop and resubmit 
additional information for an acceptable independent laboratory 
validation method. Previously, the Agency reviewed all available data, 
and concluded that these import tolerances meet the safety standard 
under FFDCA section 408(b)(2)(A)(ii). The basis for that conclusion is 
explained in the final rule promulgating the time-limited tolerances. 
The Agency has subsequently reviewed a complete toxicology data base 
for fenpyroximate and its z-isomer for the affected import tolerances, 
and determined that upon acceptable review of the recently submitted 
independent lab validation method, that these import tolerances may 
become permanent.

IV. Statutory and Executive Order Reviews

    This proposed rule establishes a tolerance under section 408(d) of 
the FFDCA in response to a petition submitted to the Agency. The Office 
of Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this proposed rule has 
been exempted from review under Executive Order 12866 due to its lack 
of significance, this proposed rule is not subject to Executive Order 
13211, Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed 
rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). A regulatory flexibility analysis of this 
proposed rule under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.) is not required since this action will not have a significant 
economic impact on a substantial number of small entities. Establishing 
pesticide tolerances has a positive economic impact on small entities 
because a pesticide tolerance allows the pesticide to be used in the 
production of food. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This proposed rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this proposed rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This proposed rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: April 19, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

    2. Section 180.566 is amended by revising the table in paragraph 
(a) to read as follows:


Sec.  180.566  Fenpyroximate; tolerances for residues.

    (a) * * *

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                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
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Grape, wine1                                            1.0     12/31/09
Hop1                                                     10     12/31/09
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1There are no U.S. registrations on hop and wine grape.

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[FR Doc. 04-9614 Filed 4-27-04; 8:45 am]
BILLING CODE 6560-50-S