[Federal Register Volume 69, Number 4 (Wednesday, January 7, 2004)]
[Notices]
[Pages 917-918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-87]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0308; FRL-7325-6]


Issuance of an Experimental Use Permit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has granted experimental use permits (EUP) to the 
following pesticide applicant. An EUP permits use of a pesticide for 
experimental or research purposes only in accordance with the 
limitations in the permit.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8715; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this 
action may be of particular interest to those persons who conduct or 
sponsor research on pesticides, the Agency has not attempted to 
describe all the specific entities that may be affected by this action. 
If you have any questions regarding the information in this action, 
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 an official public docket for this 
action under docket identification (ID) number OPP-2003-0308. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, CrystalMall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings athttp://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. EUP

    EPA has issued the following EUPs:
    524-EUP-93. Amendment/extension. Monsanto Company, 800 N. Lindberg 
Blvd., St. Louis, MO 63167. This EUP allows the use of the plant-
incorporated protectants MON863 x MON810 combined insecticidal trait 
stacked hybrids containingBacillus thuringiensis Cry3Bb1 protein and 
the genetic

[[Page 918]]

material necessary for its production (vector ZMIR13L) in corn MON 863 
andBacillus thuringiensis Cry1Ab delta-endotoxin and the genetic 
material necessary for its production (vector PV-ZMCT01) in corn MON810 
on 2,304 acres for breeding and observation nursery, inbred seed 
increase production, line per se and hybrid yield, insect efficacy, 
product characterization and performance/labeling, insect resistance 
management, non-target organism and benefit, and seed treatment trials. 
The program is authorized only in the States of Alabama, Arizona, 
California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, 
Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, 
Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 
North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, 
Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, 
Virginia, and Wisconsin. The EUP is effective from June 20, 2003 to 
December 31, 2003. Tolerance exemptions have been established for 
residues of the active ingredients in or on corn. In the Federal 
Register of April 23, 2003 (68 FR 19995) (FRL-7301-9), EPA announced 
the receipt of application for this EUP. No comments were received in 
response to the Federal Register notice.
    524-EUP-96. Issuance. Monsanto Company, 800 N. Lindberg Blvd., St. 
Louis, MO 63167. This EUP allows the use of the plant-incorporated 
protectants ZMIR39 x MON810 combined insecticidal trait stacked corn 
hybrids along with ZMIR39 and MON810 corn hybrids; Bacillus 
thuringiensis Cry3Bb1 protein and the genetic material necessary for 
its production (vector ZMIR39) in corn ZMIR39 andBacillus thuringiensis 
Cry1Ab delta-endotoxin and the genetic material necessary for its 
production (vector PV-ZMCT01) in corn MON810 on 829.7 acres of field 
corn for breeding and observation nursery, inbred seed increase 
production, line per se and hybrid yield, insect efficacy, product 
characterization and performance/labeling, insect resistance 
management, non-target organism and benefit, seed treatment, swine 
growth and feed efficiency, dairy cattle feed efficiency, beef cattle 
growth and feed efficiency, and cattle grazing feed efficiency trials. 
The program is authorized only in the States of Alabama, California, 
Colorado, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, 
Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Mexico, New 
York, North Carolina, Ohio, Pennsylvania, Puerto Rico, South Dakota, 
Tennessee, Texas, Virginia, and Wisconsin. The EUP is effective from 
July 2, 2003 to December 31, 2003. Tolerance exemptions have been 
established for residues of the active ingredients in or on corn.
    In the Federal Register of April 2, 2003 (68 FR 16050) (FRL-7286-
2), EPA announced the receipt of application for this EUP. One comment, 
by the Sierra Club, was received in response to theFederal Register 
notice. The Sierra Club commented that EPA should require additional 
testing requirements in order to look for reproductive and chronic 
effects in the animal feeding trials. The Cry3Bb1 protein has not been 
shown to be toxic to humans and the Agency concluded on May 11, 2001 
(66 FR 24061) (FRL-6781-6), that there is a reasonable certainty that 
no harm will result from aggregate exposure to the U.S. population, 
including infants and children, to the Cry3Bb1 protein and the genetic 
material necessary for their production in corn (40 CFR 180.1214). 
Accordingly, the Agency does not agree that such additional testing as 
requested by the Sierra Club is necessary. Nevertheless, although the 
Agency is not requiring Monsanto to modify its experimental program as 
requested by the Sierra Club in their comments, Monsanto must 
immediately notify the Agency of any findings from the experimental 
uses that have a bearing on safety (i.e., reporting to the Agency of 
any adverse effects from the use of, or exposure to, the pesticide is 
required).

    Authority: 7 U.S.C. 136c.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: December 19, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 04-87 Filed 1-6-04; 8:45 am]
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