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Issuance of an Experimental Use Permit

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Environmental Protection Agency (EPA).




EPA has granted an experimental use permit (EUP) (524-EUP-99) to the pesticide applicant--Monsanto Company. An EUP permits use of a pesticide for experimental or research purposes only in accordance with the limitations in the permit.

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Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8715; e-mail address: Mike

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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 a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0933. Publicly available docket materials are available either in the electronic docket at, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility 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​fedrgstr.


EPA has issued the following EUP:

524-EUP-99—Issuance. Monsanto Company, 800 N. Lindbergh Blvd St. Louis, MO 63167. This EUP allows the use of the plant-incorporated protectants:

1. Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary for its production (vector PV-ZMIR245) in event MON 89034 corn,

2. Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production (vector PV-ZMIR245) in event MON 89034 corn,

3. Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (vector ZMIR39) in event MON 88017 corn (Organization for Economic Cooperation Development (OECD) Unique Identifier: MON-88017-3),

4. Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production (plasmid insert PHI 8999) in corn (TC1507),

5. Bacillus thuringiensis Cry34Ab1 and Cry 35Ab1 proteins and the genetic material necessary for their production (plasmid insert PHP 17662) in event DAS-59122-7 corn.

These plant-incorporated protectants will be planted in the following combinations:

  • MON 89034,
  • MON 89034 x MON 88017,
  • MON 89034 x TC1507,
  • MON 89034 x DAS-59122-7,
  • MON 89034 x MON 88017 x TC1507,
  • MON 89034 x TC1507 x DAS-59122-7,
  • MON 89034 x MON 88017 x DAS-59122-7,
  • MON 88017 x TC1507 x DAS-59122-7,
  • MON 88017,
  • TC1507,
  • DAS-59122-7,
  • TC1507 x DAS-59122-7, and
  • MON 89034 x MON 88017 x TC1507 x DAS-59122-7.

The quantity authorized equates to 73, 080 lbs of corn seed (4.385 lbs active ingredients) on 4993 acres. This program is authorized to take place in the states of Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington, and Wisconsin. This EUP is effective from July 17, 2008, through June 30, 2009, and allows the protocols of breeding and observation, inbred seed increase and sample hybrid production, line per se, hybrid yield and herbicide tolerance trials, insect efficacy, product characterization and performance trials, insect resistance management trials, benefit trials, and seed treatment trials.

Two comments were submitted in response to the notice of receipt for this permit application which was published in the Federal Register on April 16, 2008 (73 FR 20625) (FRL-8357-8). Both comments were submitted by one individual who objected to issuance of an EUP. Comments expressed concern over Monsanto's credibility, unspecified environmental and human health effects, as well as the Agency's methodology in granting EUPs. The Agency understands the commenter's concerns and recognizes that some individuals believe that genetically modified crops and food should be banned completely. However, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Agency is tasked with reviewing applications for EUPs and granting such applications to the extent that the conditions of FIFRA section 5, and the regulations thereunder, have been met (subject to such terms and conditions as the Agency determines are warranted). In this instance, EPA has determined that the relevant statutory and regulatory conditions have been met. Furthermore, EPA has concluded that there is a reasonable certainty that no harm will result from dietary exposure to these proteins as expressed in corn. Further, the Agency has concluded that no adverse environmental effects will be expected from their expression in corn via the subject testing which is of limited scope and duration.

III. What is the Agency's Authority for Taking this Action?

The Agency's authority for taking this action is 7 U.S.C. 136c.

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List of Subjects

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Dated: December 29, 2008.

W. Michael McDavit,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

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[FR Doc. E8-31409 Filed 1-6-09; 8:45 am]