Pesticide Products; Registration Applications
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
ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPP-2010- 0130; FRL-8812-8
Pesticide Products; Registration Applications
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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
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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
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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.
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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
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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.
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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.
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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
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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
