[Federal Register Volume 69, Number 3 (Tuesday, January 6, 2004)]
[Notices]
[Pages 658-659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-208]


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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: [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-2003-0318. 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]
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