[Federal Register: January 7, 2009 (Volume 74, Number 4)]
[Notices]               
[Page 709-710]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja09-43]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0933; FRL-8398-7]

 
Issuance of an Experimental Use Permit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: 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.

FOR FURTHER INFORMATION CONTACT: 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 Mendelsohn@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 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 http://www.regulations.gov, 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 http://www.epa.gov/fedrgstr.

II. EUP

    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.

[[Page 710]]

List of Subjects

    Environmental protection, Experimental use permits.


    Dated: December 29, 2008.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.
[FR Doc. E8-31409 Filed 1-6-09; 8:45 am]

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