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Prothioconazole; Notice of Filing of a Pesticide Petition for Establishment to Regulations for Residues in or on Soybean Commodities

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 
[Federal Register: July 12, 2006 (Volume 71, Number 133)]
[Notices]
[Page 39313-39315]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy06-64]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0520; FRL-8074-9]
 
Prothioconazole; Notice of Filing of a Pesticide Petition for 
Establishment to Regulations for Residues in or on Soybean 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 the combined 
residues of prothioconazole and its desthio metabolite in or on soybean 
commodities.

DATES: Comments must be received on or before August 11, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0520 and pesticide petition number PP 
6F7073, by one of the following methods:
    ? Federal eRulemaking Portal: http://www.regulations.gov. Exit Disclaimer 
Follow the on-line instructions for submitting comments.
    ? Mail: Office of Pesticide Programs (OPP) Regulatory 
Public Docket (7502P), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    ? Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S.

[[Page 39314]]

Crystal Drive, Arlington, VA. Deliveries are only accepted during the 
Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays). Special arrangements should be made 
for deliveries of boxed information. The Docket telephone number is 
(703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0520. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, Exit Disclaimer 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 regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through 
regulations.gov, your e-mail address will be automatically captured and 
included as part of the comment that is placed in the 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 docket index. 
Although listed in the index, some information is not publicly 
available, e.g., 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 in the electronic docket at http://www.regulations.gov, 
Exit Disclaimer or, if only available in hard copy, at the OPP 
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation 
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The Docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Lana Coppolino, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0086; e-mail address: coppolino.lana@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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
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 document by docket ID 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.

II. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under 
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, proposing the establishment or amendment of regulations in 
40 CFR part 180 for residues of pesticide chemicals in or on various 
food commodities. 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 included in 
this notice, prepared by the petitioner along with a description of the 
analytical method available for the detection and measurement of the 
pesticide chemical residues is available on EPA's Electronic Docket at 
http://www.regulations.gov. Exit Disclaimer To locate this information on the 
home page of EPA's Electronic Docket, select ``Quick Search'' and type the 
OPP docket ID number. 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 6F7073. Bayer CropScience, 2 T.W.Alexander Drive; Research Triangle

[[Page 39315]]

Park, NC 27709, proposes to establish a tolerance for the combined 
residues of the fungicide prothioconazole and its desthio metabolite in 
or on food commodities soybean, seed at 0.15 parts per million (ppm), 
soybean, forage at 5 ppm; soybean, hay at 22 ppm. Bayer CropScience has 
submitted an 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 Liquid Chromatography/Mass Spectrometry/Mass Spectrometry 
(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 JAU6476-4-hydroxy. The method 
for analysis of milk eliminated the initial extraction step in the 
tissue method.]
This method is use to measure and evaluate the chemical 
residue(s).

List of Subjects

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

    Dated: June 28, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-10862 Filed 7-11-06; 8:45 am]
BILLING CODE 6560-50-S

 
 

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