[Federal Register: August 21, 2002 (Volume 67, Number 162)]
[Notices]               
[Page 54187-54188]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au02-62]                         

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0186; FRL-7193-3]

 
Pesticide Product; Registration 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 product Bollgard II containing an active 
ingredient not included in any previously registered product pursuant 
to the provisions of section 3(c)(5) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5412; e-mail address: 
cole.leonard@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:


------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    To access a fact sheet which provides more detail on this 
registration, go to the Home Page for the Office of Pesticide Programs 
at http://www.epa.gov/pesticides/, and select ``fact sheet.''
    2.In person. The Agency has established an official record for this 
action under docket control number OPP-2002-0186. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as Confidential Business Information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    In accordance with section 3(c)(2) of FIFRA, a copy of the approved 
label, 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. The request 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 Road, Springfield, VA 22161.

II. Did EPA Approve the Application?

    The Agency approved the application after considering all required 
data on risks associated with the proposed use of Cry1Ac and Cry2Ab 
stacked proteins, and information on social, economic, and 
environmental benefits to be derived from use. Specifically, the

[[Page 54188]]

Agency has considered the nature of the chemical 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 Cry1Ac and 
Cry2Ab stacked proteins when used in accordance with widespread and 
commonly recognized practice, will not generally cause unreasonable 
adverse effects to the environment.

III. Approved Applications

    EPA issued a notice, published in the Federal Register of March 21, 
2001 (66 FR 15867) (FRL-6770-6), which announced that Monsanto Company, 
700 Chesterfield Parkway North, St. Louis, MO 63198, had submitted an 
application to register the pesticide product, Bollgard II Cotton (EPA 
File Symbol 524-LEE) containing the active Bacillus thuringiensis 
Cry2Ab protein and the genetic material necessary for its production 
(Vector GHBK11L) in cotton. Monsanto transformed a Bollgard cotton 
variety with vector GHBK11L using particle bombardment to add the 
Cry2Ab gene for full commercial registration on cotton. This product 
was not previously registered.
    The application was approved on June 14, 2002, as Bollgard II, 
Plant-incorporated protectant containing Cry1Ac and Cry2Ab stacked 
proteins (EPA Registration Number 524-522) for a 20,000 acre seed 
increase.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: August 7, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 02-20873 Filed 8-20-02; 8:45 am]
BILLING CODE 6560-50-S