04-86. Issuance of an Experimental Use Permit

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA has granted an experimental use permit (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-2003-0299. 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 EUP:

68467-EUP-4. Extension/amendment. 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 Cry1F protein and the genetic material necessary for its production (from the insert of plasmid PHP12537) in corn (moCry1F corn) on 291 acres of field corn to conduct insect resistance management, agronomic observation, breeding and observation nursery, efficacy, maize demonstration, and herbicide tolerance study trials. The program is authorized only in the States of Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Mississippi, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin and the Commonwealth of Puerto Rico. EUP plantings are effective from April 11, 2003 to March 31, 2004.

In the Federal Register of March 7, 2003 (68 FR 11103) (FRL-7289-3), EPA announced the notice of receipt for the amendment/extension application (docket identification number OPP-2003-0016). Fifteen public comments were received in response to the notice. Commenters requested EPA not to issue the amendment/extension and expressed concern regarding food and environmental safety, gene flow, impacts on organic production, and the level of government oversight.First, moCry1F corn is covered by the tolerance exemption that permits Cry1F corn in food, 40 CFR 180.1217, (66 FR 30321) (FRL-6783-3). In granting that tolerance exemption, the Agency concluded 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 Cry1F protein and the genetic material necessary for its production. In addition, the approved experimental program submitted by Mycogen Seeds, c/o Dow AgroSciences LLC requires the destruction of seed or plant material resulting from this permit that are not saved for future research, analysis, or future plantings.This EUP was limited to 291 acres and moCry1F corn produces the Cry1F protein whose non-target organism toxicity was evaluated during the Bt Crops Reassessment in October 2001 (October 15, 2001 Plant-Incorporated Protectants Biopesticide Registration Action Document (pages II.C38-C44, VI.2), http://www.epa.gov/​pesticides/​biopesticides/​pips/​bt_​brad.htm). In the Cry1F ecological effects testing done, no treatment-related effects were observed in bobwhite quail fed Cry1F corn as part of their diet. No measurable deleterious effects from the Cry1F protein on honey bees, parasitic wasps, ladybird beetles, green lacewings, collembola (springtails), earthworms, daphnia, and monarch butterflies were observed in submitted studies. The reassessment document also addresses the concern raised regarding impacts on organic production in its benefits section (II.E2-6). 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.