Document ID: EPA-HQ-OPP-2010-0130-0081
Agency: epa
Document Type: Notice
Title: Pesticide Product Registrations: Conditional Approval
Posted Date: 2011-01-05T05:00Z

[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 551-552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-33279]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0130; FRL-8855-2]

Pesticide Product Registrations; Conditional Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces Agency approval of an application to 
register the pesticide products Spirotetramat Technical, Movento, BYI 
8330 150 OD Insecticide, Ultor, and Spirotetramat 240 SC Greenhouse & 
Nursery Insecticide/Miticide containing an active ingredient not 
included in any previously registered products pursuant to the 
provisions of section 3(c)(7) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended. Spirotetramat is a tetramic 
acid derivative (ketoenole), and is active against sucking insects in 
vegetables, citrus, pome fruit, stone fruit, grapes, cotton and other 
plants. It is systemic (xylem and phloem mobile) and can control hidden 
pests and protect new shoots.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division 
(7505P), 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. How can I get copies of this document and other related information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2010-0130. 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 Office of Pesticide Programs (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.
    In accordance with section 3(c)(2) of FIFRA, a copy of the approved 
labels, the list of data references, the data and other scientific 
information used to support registration, except for material 
specifically protected by section 10 of FIFRA, are also available for 
public inspection. Requests for data must be made in accordance with 
the provisions of the Freedom of Information Act and must be addressed 
to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001. Such requests should: Identify the 
product name and registration number and specify the data or 
information desired.
    A paper copy of the fact sheet, which provides more detail on this 
registration, may be obtained from the National Technical Information 
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.

II. Did EPA conditionally approve the application?

    A conditional registration may be granted under section 3(c)(7)(C) 
of FIFRA for a new active ingredient where certain data are lacking, on 
condition that such data are received by the end of the conditional 
registration period and do not meet or exceed the risk criteria set 
forth in 40 CFR 154.7; that use of the pesticide during the conditional 
registration period will not cause unreasonable adverse effects; and 
that use of the pesticide is in the public interest. The Agency has 
considered the available data on the risks associated with the proposed 
use of spirotetramat, and information on social, economic, and 
environmental benefits to be derived from such use. Specifically, the 
Agency has considered the nature and its pattern of use, application 
methods and rates, and level and extent of potential exposure. Based on 
these reviews, the Agency was able to make basic health and safety 
determinations which show that use of spirotetramat during the period 
of conditional registration will not cause any unreasonable adverse 
effect on the environment, and that use of the pesticide is in the 
public interest.
    Consistent with section 3(c)(7)(C) of FIFRA, the Agency has 
determined that these conditional registrations are in the public 
interest. Use of the pesticides are of significance to the user 
community, and appropriate labeling, use directions, and other measures 
have been taken to ensure that use of the pesticides will not result in 
unreasonable adverse effects to man and the environment.

III. Approved Applications

    EPA issued a notice, published in the Federal Register of February 
26, 2010 (75 FR 8939) (FRL-8812-8), which announced that Bayer 
CropScience and Bayer Environmental Science had submitted applications 
to register the pesticide products, Spirotetramat Technical, Movento, 
BYI 8330 150 OD Insecticide, Ultor, and Spirotetramat 240 SC Greenhouse 
& Nursery Insecticide/Miticide, for control of insect pests, (EPA File 
Symbols 264-RNUO, 264-RNLN, 264-RNLR, 264-RNAL, and 432-RUTR), 
containing 97.37%, 22.4%, 15.3%, 14.5%, and 22.4% active ingredient 
respectively. These products were previously registered in 2008, but 
the registrations were vacated by court order on December 23, 2009, due 
to lack of publication of a notice of receipt of the registration 
applications in the Federal Register under section 3(c)(4) of FIFRA. As 
a result of the vacatur, EPA treated Bayer's earlier-filed applications 
for registration as then-pending before the Agency.
    The applications were conditionally approved on October 15, 2010, 
as Spirotetramat Technical, Movento, BYI 8330 150 OD Insecticide, 
Ultor, and Spirotetramat 240 SC Greenhouse & Nursery Insecticide/
Miticide (EPA Registration Numbers 264-1049, 264-1050, 264-1051, 264-
1065, and 432-

[[Page 552]]

1471 respectively) for insect control on citrus, grapes, pome fruit, 
stone fruit, tree nuts, hops, Christmas tree plantations, vegetables 
except cucurbits, potato, greenhouses, nurseries, and interiorscapes. 
The registrations for end-use products were limited to 3 years, 
expiring on October 15, 2013.

IV. Missing Data

    1. Conditional data required for Spirotetramat Technical consists 
of:
    a. Avian Reproduction Study with the Mallard Duck (Anas 
platyrhynchos) (OPPTS Guideline 850.2300).
    b. Immunotoxicity Study (OPPTS Guideline 870.6200).
    c. Subchronic Neurotoxicity Study (OPPTS Guideline 870.6200).
    d. Full-scale five-batch preliminary analysis of the technical 
material (OPPTS Guideline 830.1700).
    2. Conditional data required for the end-use products consists of:
    a. Residue Analysis of Nectar and Pollen in Flowering Citrus (OPPTS 
Guideline: Special Study).
    b. Residue Analysis of Nectar and Pollen in Flowering Tree Crops 
OPPTS Guideline: Special Study).

V. Response to Comments

    EPA issued a notice, published in the Federal Register of February 
26, 2010 (75 FR 8939), which announced that Bayer CropScience and Bayer 
Environmental Science had submitted applications to register the 
pesticide products, Spirotetramat Technical, Movento, BYI 8330 150 OD 
Insecticide, Ultor, and Spirotetramat 240 SC Greenhouse & Nursery 
Insecticide/Miticide. During the public comment period of this notice, 
comments were received from growers, non-governmental organizations, 
and the applicant. EPA's response to these comments is posted to the 
docket EPA-HQ-OPP-2010-0130.

List of Subjects

    Environmental protection, Chemicals, Pests and pesticides.

    Dated: December 23, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2010-33279 Filed 1-4-11; 8:45 am]
BILLING CODE 6560-50-P