04-208. Issuance of Experimental Use Permits

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; e-mail address: [e-mail].

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 [phone].

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 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.