[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