[Federal Register Volume 70, Number 229 (Wednesday, November 30, 2005)]
[Notices]
[Pages 71831-71834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23438]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0312; FRL-7747-6]


Notice of Filing of a Pesticide Petition for the Establishment of 
Regulations for Residues of the Fungicide Prothioconazole and its 
Metabolites 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 
fungicide prothioconazole and its desthio metabolite in or on barley, 
bran/grain/hay/pearled/straw; black mustard/borage/canola/ crambe/field 
mustard/flax/Indian mustard/Indian rapeseed/rapeseed, seed; flax, grain 
and aspirated fractions; peas and beans, dried shelled (except 
soybeans); peanut, nutmeat/hay/ meal; rice, grain/straw/hulls; and 
wheat, grain/bran/forage/germ/hay/straw; and for residues of 
prothioconazole, its desthio and 4-hydroxy metabolites, and conjugates 
of each in cattle, meat/meat byproducts/fat/milk.

DATES: Comments must be received on or before December 30, 2005.

ADDRESSES: Comments, identified by docket identification (ID) number 
OPP-2005-0312 and pesticide petition (PP) number PP 4F6830, 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: Lana Coppolino, Registration Division 
(7505C), Office of Pesticide Programs, U.S. Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
telephone number: 703-305-0086; 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 code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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    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-2005-0312. 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 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, 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. 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 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-2005-0312. 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-2005-0312. 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

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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-2005-0312.
    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-2005-0312. 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 and the pesticide petition number of 
the summary of interest 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 comments.

II. What Action is the Agency Taking?

    EPA is printing a 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 fungicide prothioconazole and its desthio 
metabolite in or on barley, bran/grain/hay/pearled/straw; black 
mustard/borage/canola/ crambe/field mustard/flax/Indian mustard/Indian 
rapeseed /rapeseed, seed; flax, grain and aspirated fractions; peas and 
beans, dried shelled (except soybeans); peanut, nutmeat/hay/ meal; 
rice, grain/straw/hulls; and wheat, grain/bran/ forage/germ/hay/straw; 
and for residues of prothioconazole, its desthio and 4-hydroxy 
metabolites, and conjugates of each in cattle, meat/meat byproducts/
fat/milk. 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 4F6830. Bayer CropScience, 2 T. W. Alexander Dr., Research 
Triangle Park, NC 27709, proposes to establish a tolerance for residues 
of the fungicide prothioconazole and its desthio metabolite in or on 
food and feed commodities barley, grain at 0.2 parts per million (ppm); 
barley, hay at 7.0 ppm; barley, straw at 2.0 ppm; barley, pearled at 
0.2 ppm; barley, bran at 0.4 ppm; black mustard, seed at 0.10 ppm; 
borage, seed at 0.1 ppm; canola, seed at 0.1 ppm; crambe, seed at 0.1 
ppm; field mustard, seed at 0.1 ppm; flax, seed at 0.1 ppm; grain, 
aspirated fractions at 13.0 ppm; Indian mustard, seed at 0.1 ppm; 
Indian rapeseed at 0.1 ppm; pea and bean, dried shelled, except 
soybean, subgroup at 0.8 ppm; peanut, nutmeat at 0.02 ppm; peanut, hay 
at 5.0 ppm; peanut, meal at 0.3 ppm; rapeseed at 0.1 ppm; rice, grain 
at 0.25 ppm; rice, straw at 1.5 ppm; rice, hulls at 1.0 ppm; wheat, 
grain at 0.06 ppm; wheat, bran at 1.5 ppm; wheat, forage at 7.0 ppm; 
wheat, germ at 0.15 ppm; wheat, hay at 4.0 ppm; and wheat, straw at 2.3 
ppm; as well as tolerances for residues of prothioconazole, its desthio 
metabolite, and 4-hydroxy metabolite and conjugates of each in meat, 
cattle at 0.01 ppm; meat by-products, cattle at 1.2 ppm; fat, cattle at 
0.1 ppm and milk at 0.006 ppm. The analytical method for determining 
residues of concern in plants extracts residues of prothioconazole and 
JAU6476-desthio and converts the prothioconazole to JAU6476-desthio and 
JAU6476-sulfonic acid. Following addition of internal standards, the 
sample extracts are analyzed by LC/MS/MS. Radiovalidation and 
independent laboratory validation have shown that the method adequately 
quantifies prothioconazole residues in treated commodities. The 
analytical method for analysis of large animal tissues includes 
extraction of the residues of concern, followed by addition of an 
internal standard to the extract. The extract is then hydrolyzed to 
release conjugates, partitioned and analyzed by LC/MS/MS as 
prothioconazole, JAU6476-desthio and JAU6476-hydroxy. The method for 
analysis of milk eliminated the initial extraction step in the tissue 
method.

List of Subjects

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



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    Dated: November 15, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 05-23438 Filed 11-29-05; 8:45 am]
BILLING CODE 6560-50-S