Document ID: EPA-HQ-OPP-2005-0298-0001
Agency: epa
Document Type: Notice
Title: Notice of Filing of a Pesticide Petition for the Establishment of Regulations for Residues of the Insecticide Clothianidin in or on Food Commodities
Posted Date: 2005-12-14T13:40Z

[Federal Register: December 14, 2005 (Volume 70, Number 239)]
[Notices]               
[Page 74003-74005]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de05-58]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0298; FRL-7747-4]

 
Notice of Filing of a Pesticide Petition for the Establishment of 
Regulations for Residues of the Insecticide Clothianidin in or on Food 
Commodities

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 regulations for residues of the 
insecticide clothianidin in or on cotton, undelinted seed and cotton, 
gin byproducts.

DATES: Comments must be received on or before January 13, 2006.

ADDRESSES: Comments, identified by docket identification (ID) number 
EPA-HQ-OPP-2005-0298 and pesticide petition (PP) number 5F6908, may be 
submitted electronically, by mail, or through hand delivery or courier. 
Follow the detailed instructions as provided in Unit I. of the 
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Kable Davis, Registration Division 
(7505C), Office of Pesticide Programs, U. S. Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; phone 
number: 703-306-0415, e-mail address: davis.kable@epa.gov.

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 code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 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. EPA has established an official public docket for this action 
under docket ID number EPA-HQ-OPP-2005-0298. 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

[[Page 74004]]

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. You may access this document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/
.

    Agency Web site. EDOCKET, EPA's electronic public docket and 
comment system was replaced on November 25, 2005, by an enhanced 
federal-wide electronic docket management and comment system located at 
http://www.regulations.gov. Follow the online instructions.

    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, to 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.1. 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. 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 and cannot contact you for clarification, EPA 
may not be able to consider your comment.
    i. 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 EPA-HQ-OPP-2005-0298. 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 opp-docket@epa.gov, 
Attention: Docket ID Number EPA-HQ-OPP-2005-0298. 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 EPA-HQ-OPP-2005-
0298.
    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 EPA-HQ-OPP-2005-0298. Such deliveries are only accepted during 
the docket's normal hours of operation as identified in Unit I.B.1.

[[Page 74005]]

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 and the pesticide petition number of 
the summary in the subject line on the first page of your response. It 
would also be helpful if you provided the name, date, and Federal 
Register citation related to your comment.

II. What Action Is the Agency Taking?

    EPA is printing the summary of the pesticide petition received 
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a, proposing the establishment of regulations in 40 CFR 
part 180 for residues of the insecticide clothianidin in or on cotton, 
undelinted seed and cotton, gin byproducts. EPA has determined that 
this pesticide 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 pesticide petition. Additional 
data may be needed before EPA rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition, prepared by 
the petitioner along with a description of the analytical methods 
available for the detection and measurement of the pesticide chemical 
residues is available on EPA's Electronic Docket at http://www.epa.gov/edocket.
 To locate this information, on the home page of EPA's 

Electronic Docket select ``Quick Search'' and type the OPP docket ID 
number for the pesticide petition (as specified in Unit I.B.1.) in the 
search field. Once the search has located the docket, clicking on the 
``Docket ID'' will bring up a list of all documents in the docket for 
the pesticide including the petition summary.

New Tolerance

    PP 5F6908. Bayer CropScience, 2 T.W. Alexander Drive, Research 
Triangle Park, NC 27709, proposes to establish a tolerance for residues 
of the insecticide clothianidin in or on raw agricultural commodities 
cotton, undelinted seed at 0.01 parts per million (ppm); and cotton, 
gin byproducts at 0.01 ppm. In plants and plant products, the residue 
of concern, parent clothianidin, can be determined using High 
Performance Liquid Chromatography (HPLC) with Electrospray Mass 
Spectrometry/Mass Spectrometry Detection (MS/MS detection). In an 
extraction efficiency testing, the plant residues method has also 
demonstrated the ability to extract aged clothianidin residue. Although 
the plant residues Liquid Chromatography (LC)-MS/MS method is highly 
suitable for enforcement method, an LC-Ultraviolet (UV) method has also 
been developed which is suitable for enforcement (monitoring) purposes 
in all relevant matrices.

List of Subjects

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

    Dated: December 1, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 05-23975 Filed 12-13-05; 8:45 am]

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