Pesticide Experimental Use Permit Applications


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[Federal Register Volume 77, Number 225 (Wednesday, November 21, 2012)]
[Pages 69838-69839]
From the Federal Register Online via the Government Printing Office []
[FR Doc No: 2012-28215]

[[Page 69838]]



[EPA-HQ-OPP-2012-0780; FRL-9368-5]

MON 87410 and MON 87411 Pesticide-Incorporated Protectant Corn
Events: Pesticide Experimental Use Permit; Receipt of Application;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: This notice announces EPA’s receipt of an application 524-EUP-
RNU from Monsanto Company requesting an experimental use permit (EUP)
for the plant-incorporated protectants (PIPs) corn events with a double
stranded RNA (dsRNA) transcript comprising a Dv49 inverted repeat
sequence derived from Diabrotica virgifera, and the genetic material
necessary for its production (vector PV-ZMIR10871). These events are
proposed for experimental use in combination with single and combined
traits against lepidoptera and corn rootworm (CRW). The Agency has
determined that the permit may be of regional and national
significance. Therefore, because of the potential significance, EPA is
seeking comments on this application.

DATES: Comments must be received on or before December 21, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0780, by one of the following methods:
    Federal eRulemaking Portal:
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
    Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC
    Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8097; email


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.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general

II. What action is the agency taking?

    Under section 5 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), 7 U.S.C. 136c, EPA can allow manufacturers to
field test pesticides under development. Manufacturers are required to
obtain an EUP before testing new pesticides or new uses of pesticides
if they conduct experimental field tests on 10 acres or more of land or
one acre or more of water.
    In accordance with 40 CFR 172.11(a), the Agency has determined that
the following EUP application may be of regional and national
significance, and therefore is seeking public comment on the EUP
    Submitter: Monsanto Company, (524-EUP-RNU).
    Pesticide Chemical: Double stranded RNA (dsRNA) transcript
comprising a Dv49 inverted repeat sequence derived from Diabrotica
virgifera, and the genetic material necessary for its production
(vector PV-ZMIR10871).
    Summary of Request: Monsanto is requesting a EUP for two years to
test new PIP technology for control of corn rootworm (CRW), a major
pest of corn in the United States (U.S.). Corn Events MON 87410 and
87411 express a double stranded RNA (dsRNA) transcript suppression
cassette with an inverted repeat sequence, Dv49, obtained from
Diabrotica virgifera. When PIP-produced Dv49 dsRNA is consumed by the
pest, it down regulates the targeted pest’s Snf7 gene, resulting in
pest mortality.
    As described in the application documents for 524-EUP-RNU in this
docket, the PIP events comprising the single and combined trait
products in this request include other registered PIP Bacillus
thuringiensis (Bt) proteins and either of the two new corn events MON
87410 and 87411. The Bt proteins to be used in the single or
combination traits

[[Page 69839]]

in the proposed EUP include Cry1A.105, Cry2Ab2, Cry IF, Vip3Aa20,
Cry3Bb1, Cry34Abl/Cry35Abl and eCry3.1Ab. The environmental and human
health safety of these proteins has been demonstrated, and they are
exempted from the requirement of a tolerance (40 CFR 174.501, 174.502,
174.506, 174.518, 174.519, 174.520, 174.528, 174.532). A permanent
tolerance exemption has been established for nucleic acids including
the dsRNA that is part of the PIPs (40 CFR 174.507). Other marker
proteins PAT, CP4 EPSPS, and PMI are also exempt from the requirement
of a tolerance (40 CFR 174.522, 174.523, 174.527).
    The tests will be conducted in the U.S. territory of Puerto Rico
and in the U.S. in twenty two (22) states as follows: Arkansas (AR),
California (CA), Colorado (CO), Georgia (GA), Hawaii (HI), Idaho (ID),
Illinois (IL), Indiana (IN), Iowa (IA), Kansas (KS), Michigan (MI),
Minnesota (MN), Mississippi (MS), Missouri (MO), Nebraska (NE), North
Carolina (NC), Ohio (OH), Pennsylvania (PA), South Carolina (SC), South
Dakota (SD), Tennessee (TN), Wisconsin (WI).
    The two protocols in the EUP include: (1) Seed development and
increase for future testing including nursery observations of traits in
various genetic backgrounds; and (2) product characterization work
including phenotypic and agronomic observations, efficacy, yield
benefit evaluations and regulatory data generation.
    A copy of the application and any information submitted is
available for public review in the docket established for this EUP
    Following the review of the application and any comments and data
received in response to this solicitation, EPA will decide whether to
issue or deny the EUP request, and if issued, the conditions under
which it is to be conducted. Any issuance of an EUP will be announced
in the Federal Register.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: November 8, 2012,
Keith Matthews,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 2012-28215 Filed 11-20-12; 8:45 am]



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