[Federal Register: January 6, 2004 (Volume 69, Number 3)]
[Notices]
[Page 658-659]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja04-82]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0318; FRL-7328-5]
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-2003-0318. 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,
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 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.
II. EUP
EPA has issued the following EUPs:
68467-EUP-7. Issuance. Mycogen Seeds c/o Dow AgroSciences LLC, 9330
Zionsville Road, Indianapolis, IN
[[Page 659]]
46268-1054. This EUP allows the use 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 624 acres of field corn to conduct insect
resistance management, maize agronomic observation, maize breeding and
observation nursery, maize demonstration, maize efficacy, maize hybrid
production plots, maize regulatory field studies, non-target organism,
and herbicide tolerance trials. The program is authorized only in the
States of California, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas,
Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio,
Pennsylvania, South Dakota, Tennessee, Texas, Wisconsin, and the
Commonwealth of Puerto Rico. The EUP is effective from June 24, 2003 to
May 1, 2004.
29964-EUP-5. Issuance. Pioneer Hi-Bred International, Inc., P.O.
Box 552, Johnston, Iowa 50131-0552. This EUP allows the use 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 624 acres of field corn to
conduct insect resistance management, maize agronomic observation,
maize breeding and observation nursery, maize demonstration, maize
efficacy, maize hybrid production plots, maize regulatory field
studies, non-target organism, and herbicide tolerance trials. The
program is authorized only in the States of California, Georgia,
Hawaii, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri,
Nebraska, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee,
Texas, Wisconsin, and the Commonwealth of Puerto Rico. The EUP is
effective from June 24, 2003 to May 1, 2004.
A tolerance has been established for residues of Bacillus
thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material
necessary for their production in corn when used as plant-incorporated
protectants in the food and feed commodities of field corn, sweet corn,
and popcorn.
The Federal Register document announcing receipt of these and other
Cry34/35Ab1 EUPs (68 FR 12073) (FRL-7286-3) received 42 comments, with
4 of these being received after the comment due date. Thirty commentors
were in favor of EPA granting the EUPs. Twelve commentors urged the
Agency not to approve them. Commentors included farmers and other
private citizens, medium to smaller seed companies, the American
Soybean Association, and the environmental groups Hawaii Genetic
Engineering Action Network and Earthjustice.
Commentors in favor of EPA granting the EUPs cited the reduced use
of conventional insecticides, insect resistant management benefits, a
lack of antibiotic resistance marker proteins in the Cry34/35Ab1 corn
products, the need for competition in the marketplace for rootworm
resistant corn, and the need to test the products this season.
Commentors against EPA's granting of the permits cited that there was
no tolerance exemption for Cry34/35Ab1, allergen and toxin concerns,
concerns regarding adequate containment, and concerns regarding EPA
enforcement.
First, EPA has, in fact, granted a temporary exemption from the
requirement of a tolerance for Bacillus thuringiensis Cry34Ab1 and
Cry35Ab1 proteins and the genetic material necessary for their
production in corn, 40 CFR 180.1242 (68 FR 40178) (FRL-7310-1). In
doing so, EPA concluded that there was a reasonable certainty that no
harm will result from aggregate exposure to the U.S. population,
including infants and children, to the Cry34Ab1 and Cry35Ab1 proteins
and the genetic material necessary for their production. In addition,
although the subject EUPs have a temporary tolerance exemption
associated with them and under this condition EPA would not normally
require such containment, both Dow and Pioneer's experimental programs
require containment consisting of border rows; (distance isolation of
660 ft., or reproductive isolation, or temporal isolation); as well as
having seed produced reserved for experimental work or future
plantings. Finally, EPA's regional offices currently cooperate with
State agencies in the enforcement of plant-incorporated protectant
EUPs.
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. 04-208 Filed 1-5-04; 8:45 am]
BILLING CODE 6560-50-S