[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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