[Federal Register Volume 69, Number 246 (Thursday, December 23, 2004)]
[Notices]
[Pages 76942-76945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28095]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0422; FRL-7694-1]


Buprofezin; Notice of Filing a Pesticide Petition to Establish a 
Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of

[[Page 76943]]

regulations for residues of a certain pesticide chemical in or on 
various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2004-0422, must be received on or before January 24, 2005.

ADDRESSES:  Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Richard J. Gebken, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6701; 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 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0422. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. 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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties

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and cannot contact you for clarification, EPA may not be able to 
consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0422. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2004-0422. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0422.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0422. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

 D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
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 CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

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

     You may find the following suggestions helpful for preparing your 
comments:
     1. Explain your views as clearly as possible.
     2. Describe any assumptions that you used.
     3. Provide copies of any technical information and/or data you 
used that support your views.
     4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
     5. Provide specific examples to illustrate your concerns.
     6. Make sure to submit your comments by the deadline in this 
notice.
     7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

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


    Dated: December 17, 2004.
Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

Nichino America, Inc.

PP 4F6887

    EPA has received a revision to pesticide petition (PP 4F6887) from 
Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, 
Wilmington, DE 19808, proposing, pursuant to section 408(d) of the 
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.511 by establishing 
permanent tolerances for residues of buprofezin (2-[(1,1-
dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one) in or on the following raw agricultural commodities: 
Head lettuce, leaf lettuce, vegetables, vegetables, cucurbits, group 9.

A. Background

    In the Federal Register of August 26, 1998 (63 FR 45483) (FRL-5791-
1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), as amended by the Food Quality Protection Act of 
1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide 
petition (PP 7F4923) by Nichino America, Inc., 4550 New Linden Hill 
Road, Wilmington, DE 19808. The petition requested that 40 CFR 180.511 
be amended by establishing a tolerance for residues of the insecticide 
buprofezin in or on head lettuce, leaf lettuce, and vegetables, 
cucurbits, group 9 at 5.0, 13.0, and 0.50 parts per million (ppm), 
respectively.

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The notice included a summary of the petition prepared by Nichino 
America, Inc., the registrant. There were no comments received in 
response to the initial notice of filing. On August 31, 2000 (65 FR 
52938) (FRL-6740-1), 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 tolerances in conjunction to the original pesticide petition 
(PP 7F4923).
    These tolerances were time-limited because the Agency lacked data 
on a developmental neurotoxicity study in rats (OPPTS Harmonized 
Guideline 870.6300) guideline requirement (40 CFR part 158) for food/
feed use, validation of frozen storage intervals, petition method 
validation, an interference study, a confirmatory method, and 
additional cantaloupe and leaf lettuce field trials.
    Nichino America, Inc. has addressed all the data deficiencies, 
identified in the final rule described above, and is therefore 
requesting that permanent tolerances be established for head and leaf 
lettuce and vegetables, cucurbits, group 7 at 5.0, 13.0, and 0.50 ppm, 
respectively.

B. Toxicological Profile

    An extensive battery of toxicology studies has been conducted with 
buprofezin. EPA has evaluated the available toxicity data and 
considered its validity, completeness, and reliability as well as the 
relationship of the results of the studies to human risk The nature of 
the toxic effects caused by buprofezin is discussed in Unit III.A. of 
the final rule on Buprofezin Pesticide Tolerance published in the 
Federal Register of August 31, 2000 (65 FR 52938) (FRL-6740-1). A 
subsequent assessment of toxic effects caused by buprofezin, including 
the toxicological endpoints of concern, is discussed in Unit III.A. and 
Unit III.B. of the final rule in the Federal Register published June 
25, 2003 (68 FR 37766) (FRL-7310-7).

C. Aggregate Exposure

    The Agency conducted acute and chronic dietary risk analyses using 
the Dietary Exposure Evaluation Model (DEEM\TM\) and concluded that 
acute exposure to buprofezin, as a result of dietary exposure, is below 
the Agency's level of concern. The anticipated residues were used for 
evaluation. The Agency evaluated chronic risk for buprofezin, as a 
result of dietary (food and water) exposure, is below the Agency's 
level of concern. The Agency concluded with reasonable certainty that 
residues of buprofezin in food and drinking water do not contribute 
significantly to the acute or chronic aggregate human health risk.
    The term residential exposure is used in this document to refer to 
non-occupational, non-dietary exposure (e.g., for lawn and garden pest 
control, indoor pest control, termiticides, and flea and tick control 
on pets). Buprofezin is not registered for use on any sites that would 
result in residential exposure.

D. Cumulative Effects

    A determination has not been made that buprofezin has a common 
mechanism of toxicity with other substances. Buprofezin does not appear 
to produce a common toxic metabolite with other substances. A 
cumulative risk assessment was, therefore, not performed for this 
analysis.

E. Safety Determination

    Based on the acute dietary, chronic dietary, and water risk 
assessments, EPA concludes that there is a reasonable certainty that no 
harm will result to the general population and to infants and children 
from aggregate exposure to buprofezin residues.

F. International Tolerances

    Canada, Codex, and Mexico do not have maximum residue limits for 
residues of buprofezin in/on the proposed crops. Therefore, 
harmonization is not an issue.

[FR Doc. 04-28095 Filed 12-22-04; 8:45 am]
BILLING CODE 6560-50-S