04-87. Issuance of an Experimental Use Permit

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA has granted experimental use permits (EUP) to the following pesticide applicant. 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-2003-0308. 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:

524-EUP-93. Amendment/extension. Monsanto Company, 800 N. Lindberg Blvd., St. Louis, MO 63167. This EUP allows the use of the plant-incorporated protectants MON863 x MON810 combined insecticidal trait stacked hybrids containing Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (vector ZMIR13L) in corn MON 863 and Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic material necessary for its production (vector PV-ZMCT01) in corn MON810 on 2,304 acres 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, and seed treatment trials. The program is authorized only in the States of Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, and Wisconsin. The EUP is effective from June 20, 2003 to December 31, 2003. Tolerance exemptions have been established for residues of the active ingredients in or on corn. In the Federal Register of April 23, 2003 (68 FR 19995) (FRL-7301-9), EPA announced the receipt of application for this EUP. No comments were received in response to the Federal Register notice.

524-EUP-96. Issuance. Monsanto Company, 800 N. Lindberg Blvd., St. Louis, MO 63167. This EUP allows the use of the plant-incorporated protectants ZMIR39 x MON810 combined insecticidal trait stacked corn hybrids along with ZMIR39 and MON810 corn hybrids; Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (vector ZMIR39) in corn ZMIR39 and Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic material necessary for its production (vector PV-ZMCT01) in corn MON810 on 829.7 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 July 2, 2003 to December 31, 2003. Tolerance exemptions have been established for residues of the active ingredients in or on corn.

In the Federal Register of April 2, 2003 (68 FR 16050) (FRL-7286-2), EPA announced the receipt of application for this EUP. One comment, by the Sierra Club, was received in response to the Federal Register notice. The Sierra Club commented that EPA should require additional testing requirements in order to look for reproductive and chronic effects in the animal feeding trials. The Cry3Bb1 protein has not been shown to be toxic to humans and the Agency concluded on May 11, 2001 (66 FR 24061) (FRL-6781-6), that there is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to the Cry3Bb1 protein and the genetic material necessary for their production in corn (40 CFR 180.1214). Accordingly, the Agency does not agree that such additional testing as requested by the Sierra Club is necessary. Nevertheless, although the Agency is not requiring Monsanto to modify its experimental program as requested by the Sierra Club in their comments, Monsanto must immediately notify the Agency of any findings from the experimental uses that have a bearing on safety (i.e., reporting to the Agency of any adverse effects from the use of, or exposure to, the pesticide is required).

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.