[Federal Register: December 22, 2004 (Volume 69, Number 245)]
[Notices]               
[Page 76732-76733]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de04-47]                         

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0199; FRL-7688-7]

 
Issuance of Experimental Use Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has granted experimental use permits (EUPs) to the 
following pesticide applicants. 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: mendelsohn.mike@epa.gov.

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-2004-0199. 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, Crystal Mall 2, 
1801 S. Bell St., 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 at http://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.
    Information on the EUPs cited in this notice are also available on 
the ``Current Plant Incorporated Protectant (PIP) Experimental Use 
Permits'' web page on the EPA Internet. This page provides a 
consolidated list of active PIP EUPs with direct edocket links at 
http://www.epa.gov/pesticides/biopesticides/pips/current_pip_eups.htm
.


II. EUPs

    EPA has issued the following EUPs:
    524-EUP-96. Extension/Amendment. Monsanto Company, 800 North 
Lindbergh Blvd., St. Louis, MO 63167. This EUP allows the use of 2.8 
pounds of the plant-incorporated protectant Bacillus thuringiensis 
Cry3Bb1 protein and the genetic material necessary for its production 
(vector ZMIR39) in corn on 2,530 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,

[[Page 76733]]

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 April 27, 2004 to February 28, 2005. A 
tolerance has been established for residues of the active ingredient in 
or on corn.
    Two comments were submitted in response to the notice of receipt 
for this permit application, which was published in the Federal 
Register on March 3, 2004 (69 FR 10040) (FRL-7344-5). Comments were 
received from private citizens who objected to EUP issuance. They 
expressed doubt regarding Monsanto's truthfulness, were concerned about 
unspecified environmental and human health effects, as well as the 
purity of food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that genetically modified 
crops and food should be banned completely. Pursuant to its authority 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA has 
conducted a comprehensive assessment of the Cry1Ab and Cry3Bb1 delta 
endotoxins and the genetic material necessary for their production in 
corn. EPA has concluded that there is a reasonable certainty that no 
harm will result from dietary exposure to these endotoxins as expressed 
in genetically modified corn. The Cry1Ab and Cry3Bb1 corn tested under 
this permit are covered by tolerance exemptions under 40 CFR 180.1173 
and 40 CFR 180.1214. No adverse effects are anticipated as a result of 
Cry3Bb1 and/or Cry1Ab expression in transgenic corn.
    68467-EUP-7. Extension/Amendment. Mycogen Seeds c/o Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. 
This EUP allows the use of 0.94 pounds of the plant-incorporated 
protectant Bacillus thuringiensis Cry34/35Ab1 proteins and the genetic 
material necessary for their production (from the insert of plasmid 
PHP17662) in corn on 1,177 acres of field corn for maize breeding and 
observation nursery, maize agronomic observation, herbicide tolerance, 
maize efficacy, insect resistance management, and maize demonstration 
trials. The program is authorized only in the States of Arizona, 
Colorado, Delaware, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, 
Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New 
York, North Dakota, Ohio, Pennyslvania, Puerto Rico, South Dakota, 
Tennessee, Texas, Wisconsin, and Vermont. The EUP is effective from 
April 29, 2004 to April 30, 2005. A tolerance has been established for 
residues of the active ingredient in or on corn.
    29964-EUP-5. Extension/Amendment. Pioneer Hi-Bred International, 
P.O. Box 552, Johnston, IA 50131-0552. This EUP allows the use of 3.97 
pounds of the plant-incorporated protectant Bacillus thuringiensis 
Cry34/35Ab1 proteins and the genetic material necessary for their 
production (from the insert of plasmid PHP17662) in corn on 4,690 acres 
of field corn for insect resistance management, maize agronomic 
observation, maize breeding and observation, maize demonstration, maize 
efficacy, maize research seed production, maize inbred seed increase, 
maize regulatory studies, non-target organism, and herbicide tolerance 
trials. The program is authorized only in the States of Alabama, 
Arkansas, California, Colorado, Delaware, Georgia, Hawaii, Illinois, 
Indiana, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, 
Mississippi, Missouri, Nebraska, North Carolina, North Dakota, Ohio, 
Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington, 
and Wisconsin. The EUP is effective from April 29, 2004 to April 30, 
2005. A tolerance has been established for residues of the active 
ingredient in or on corn.
    One comment was submitted in response to the notice of receipt for 
this permit application, which was published in the Federal Register on 
March 10, 2004 (69 FR 11431) (FRL-7346-6). The commenter objected to 
EUP issuance. The commenter indicated denial should be based on their 
view of chemical companies' record, unspecified environmental and human 
health effects, and food purity. The Agency understands the commenter's 
concerns and recognizes that some individuals believe that genetically 
modified crops and food should be banned completely. Pursuant to its 
authority under the FFDCA, EPA has conducted a comprehensive assessment 
of the Cry34Ab1/Cry35Ab1 delta endotoxins and the genetic material 
necessary for their production in corn. EPA has concluded that there is 
a reasonable certainty that no harm will result from dietary exposure 
to these endotoxins as expressed in genetically modified corn. The 
Cry34Ab1/Cry35Ab1 tested under these permits are covered by the 
tolerance exemption under 40 CFR 180.1242. No adverse effects are 
anticipated as a result of Cry34Ab1/Cry35Ab1 expression in transgenic 
corn.


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

List of Subjects

    Environmental protection, Experimental use permits.


    Dated: December 8, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. 04-27773 Filed 12-21-04; 8:45 am]

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