Document ID: EPA-HQ-OPP-2010-0130-0001
Agency: epa
Document Type: Notice
Title: Pesticide Products; Registration Applications
Posted Date: 2010-02-26T05:00Z

[Federal Register: February 26, 2010 (Volume 75, Number 38)]
[Notices]               
[Page 8939-8942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe10-55]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010- 0130; FRL-8812-8]

 
Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register pesticide products 
containing an active ingredient not included in any previously 
registered pesticide products. Pursuant to the provisions of section 
3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), EPA is hereby providing notice of receipt and opportunity to 
comment on these applications.

DATES: Comments must be received on or before March 29, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0130, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
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 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through

[[Page 8940]]

Friday, excluding legal holidays). Special arrangements should be made 
for deliveries of boxed information. The Docket Facility telephone 
number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0130. 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, 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 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 
available at http://www.regulations.gov. 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, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., 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 Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Rita Kumar, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 308-8291; e-mail address: kumar.rita@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. Background

A. FIFRA Registration Applications

    On October 10, 2006, EPA received applications from Bayer 
CropScience LLC, 2 T.W. Alexander Drive, Research Triangle Park, NC 
27709, to register three new pesticide products containing the active 
ingredient spirotetramat - a tetramic acid derivative insecticide - 
under section 3 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), 7 U.S.C. 136a, for use on a wide variety of agricultural 
crops and on Christmas trees. On February 5, 2007, EPA received another 
application from Bayer Environmental Science for a spirotetramat end-
use product for insect control in greenhouses, nurseries, and interior 
plantscapes. On April 27, 2007, EPA received an application from Bayer 
CropScience for another spirotetramat end-use product for agricultural 
use. The applications are described in Unit IV. of this Notice.
    Although later vacated by court order (described in this unit), the 
Agency approved the applications for the technical and one end-use 
product on June 30, 2008, as Spirotetramat Technical and Movento (EPA 
Registration Number 264-1049 and 264-1050, respectively) for control of 
insects on several agricultural crops and Christmas trees. The Agency 
approved the application for Spirotetramat 240 SC Greenhouse and 
Nursery (EPA Registration Number 432-1471) on August 8, 2008 for insect 
control in greenhouses, nurseries, and interior plantscapes. The Agency 
approved the application for BYI 8330 150 OD

[[Page 8941]]

Insecticide (EPA Registration Number 264-1051) on September 24, 2008 
for control of insects on several agricultural crops and Christmas tree 
plantations. The Agency approved the application for Ultor (EPA 
Registration Number 264-1065) on December 16, 2008 for control of 
insects on several agricultural crops and Christmas tree plantations.
     On December 23, 2009, due to lack of publication of a notice of 
receipt of the spirotetramat registration applications in the Federal 
Register under section 3(c)(4) of FIFRA, the U.S. District Court for 
the Southern District of New York issued an order vacating the 
spirotetramat registrations that the Agency issued in 2008, and 
remanding the matter to EPA for further proceedings in accordance with 
FIFRA and the Administrative Procedure Act (APA). See Natural Resources 
Defense Council, Inc. v. EPA, 2009 WL 5033959 (Dec. 23, 2009). As a 
result of the court's order, the spirotetramat registration 
applications submitted to EPA in 2008 are currently pending before the 
Agency.
    While the 2009 case was pending before the U.S. District Court for 
the Southern District of New York, EPA published in the Federal 
Register on August 6, 2009 (74 FR 39321) (FRL-8431-6), a Notice of 
Pesticide Product Registration Approval; Opportunity for Public 
Comment, seeking comment on the spirotetramat registrations. EPA 
received a number of comments in response to the August 6, 2009 Notice, 
but has not responded to those comments. As described in Unit III. of 
this Notice, EPA is now issuing a new notice of receipt of the pending 
spirotetramat registration applications and opening a new comment 
period. EPA will place the comments received in response to the August 
6, 2009 Notice in the new docket and consider those comments, along 
with all new comments received, in issuing a decision on the pending 
applications. Commenters who wish the Agency to consider their earlier 
comments are welcome to submit additional comments, as well, if they so 
desire.

B. FFDCA Tolerances

    Along with the applications for registration of Spirotetramat 
Technical, Movento 240 SC Insecticide, and Movento 150 OD Insecticide 
filed on October 10, 2006, Bayer CropScience also filed a petition 
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a, to establish tolerances for residues of spirotetramat 
in or on the raw agricultural commodities citrus (Crop Group 10); 
cucurbit vegetables (Crop Group 9); fruiting vegetables (Crop Group 8); 
grape (Crop Subgroup 13F); hops; leafy Brassica vegetables (Crop Group 
5); leafy Non-Brassica vegetables (Crop Group 4); pome fruit (Crop 
Group 11); potato and other tuberous and corm vegetables (Crop Subgroup 
1C); stone fruit (Crop Group 12); tree nuts (Crop Group 14); import 
tolerances on onions and strawberries; milk; meat, fat, and meat 
byproducts of cattle, goat, hog, sheep and horse.
    EPA issued a Notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), in the Federal Register of July 25, 2007 (72 FR 
40877) (FRL-8137-1) announcing the filing of the petition for 
tolerances. EPA issued a Final Rule establishing tolerances for 
spirotetramat in the Federal Register of July 9, 2008 (73 FR 39251) 
(FRL-8367-1). The final rule establishing tolerances for spirotetramat 
was not before the court in Natural Resources Defense Council, Inc. v. 
EPA, 2009 WL 5033959 (Dec. 23, 2009), and that rule remains in effect.

III. What Action is the Agency Taking?

    EPA is now issuing a new notice of receipt of the pending 
spirotetramat registration applications and opening a new comment 
period pursuant to section 3(c)(4) of FIFRA. EPA will place the 
comments received in response to the August 6, 2009 Notice (74 FR 
39321) (FRL-8431-6) in the new docket (OPP-2010-0130) and consider 
those comments, along with all new comments received in response to the 
present Notice, in issuing a decision on the pending applications. 
Commenters to the August 6, 2009 Notice may elect to:
    1. Submit new, amended, or additional comments; or
    2. Do nothing and rely on their original comments.
    With respect to this new comment period, the question has arisen as 
to whether the spirotetramat applications will be subject to the new 
comment period opportunity EPA has been providing on certain pesticide 
applications since October 1, 2009 (see EPA's website at http://
epa.gov/pesticides/regulating/registration-public-involvement.html). 
Because of the very limited information available for comment in the 
early stages of pesticide applications, EPA last year established a 
second comment period for certain applications that takes place at the 
end of the application period, when EPA has completed its scientific 
reviews of the application and has prepared a draft decision. Given the 
amount of information that is now available to commenters with respect 
to spirotetramat, including the Agency's science reviews and risk 
assessments and the public availability of the earlier decision that 
EPA reached on the applications without the benefit of public comment, 
EPA does not believe it necessary to have two separate new comment 
periods on the spirotetramat applications; the comment period here 
commenced will provide the robust comment opportunity that the Agency 
sought to provide with the policy that went into effect on October 1, 
2009.

IV. Registration Applications

    EPA received applications as follows to register pesticide products 
containing active ingredients not included in any previously registered 
products pursuant to the provision of section 3(c)(4) of FIFRA. Notice 
of receipt of these applications does not imply a decision by the 
Agency on the applications.
    1. Applicant: Bayer CropScience LLC, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. Product name: Spirotetramat 
Technical. Product type: Insecticide. Active ingredient: Spirotetramat 
at 97.37%. PC Code: 392201. Proposed classification: None. Use: For 
formulating use only.
    2. Applicant: Bayer CropScience LLC, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. Product name: Movento. Product type: 
Insecticide. Active ingredient: Spirotetramat at 22.4%. PC Code: 
392201. Proposed classification: None. Use: For insect control on 
citrus, grapes, pome fruit, stone fruit, tree nuts, hops, Christmas 
tree plantations, vegetables, and potato.
    3. Applicant: Bayer CropScience LLC, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. Product name: Spirotetramat 240 SC 
Greenhouse and Nursery. Product type: Insecticide. Active ingredient: 
Spirotetramat at 22.4%. PC Code: 392201. Proposed classification: None. 
Use: For insect control on ornamentals, fruit and nut trees, and 
vegetable plants in greenhouses, nurseries, and interiorscapes.
    4. Applicant: Bayer CropScience LLC, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. Product name: BYI 8330 150 OD 
Insecticide. Product type: Insecticide. Active ingredient: 
Spirotetramat at 15.3%. PC Code: 392201. Proposed classification: None. 
Use: For insect control on citrus, grapes, pome fruit, stone fruit, 
tree nuts, hops, Christmas tree plantations, vegetables, and potato.
    5. Applicant: Bayer CropScience LLC, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. Product name: Ultor. Product type: 
Insecticide. Active ingredient: Spirotetramat at 14.5%. PC

[[Page 8942]]

Code: 392201. Proposed classification: None. Use: For insect control on 
citrus, grapes, pome fruit, stone fruit, tree nuts, hops, Christmas 
tree plantations, vegetables, and potato.

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: February 18, 2010.
 G. Jeffrey Herndon,
 Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2010-3857 Filed 2-25-10; 8:45 am]
BILLING CODE 6560-50-S