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: (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, 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