[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2169-2170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00389]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0780; FRL-9904-99]


Amendment of a Pesticide Experimental Use Permit; Notice of 
Receipt of Application; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's receipt of an application from 
Monsanto Company requesting to amend 524-EUP-104 experimental use 
permit (EUP) for the plant-incorporated protectants (PIPs) corn event 
MON 87411 in combination with single and combined traits against 
lepidoptera and corn rootworm (CRW). The Agency has determined that the 
amendment request for the permit may be of regional and national 
significance. Therefore, because of the potential significance, and 
pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), EPA is hereby providing notice of receipt and is seeking 
comments on this application.

DATES: Comments must be received on or before February 12, 2014. Submit 
your comments, identified by docket identification (ID) number and the 
EUP File Symbol as shown in the body of this document, by one of the 
following methods:

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number and the EUP File Symbol as shown in the body of this 
document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
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 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and 
Pollution Prevention Division (BPPD), (7511P), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 305-7090; email 
address: [email protected].

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.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov 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

[[Page 2170]]

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 
reproduced.
    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 
population.

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. 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 amended EUP request, and if 
issued, the conditions under which it is to be conducted. Any issuance 
of an amended EUP will be announced in the Federal Register.
    Therefore, pursuant to 40 CFR 172.11(a), the Agency has determined 
that the following amended EUP application may be of regional and 
national significance, and therefore is seeking public comment on the 
following amended EUP application:
    524-EUP-104. (EPA-HQ-OPP-2012-0780). On March 1, 2013, EPA approved 
an application from Monsanto Company, 800 Lindbergh Blvd., St. Louis, 
MO 63167, for an experimental use permit (EPA Reg. No. 524-EUP-104) for 
the PIPs corn events MON 87410 and MON 87411. A notice of issuance of 
the EUP was published in the Federal Register on November 21, 2013 (78 
FR 69849) (FRL-9403-1) . The corn events MON 87410 and Mon 87411 were 
approved for experimental use in combination with single and combined 
traits that produce active ingredients derived from Bacillus 
thuringiensis (Bt) and target lepidoptera and corn rootworm (CRW). The 
EUP allowed planting through February 28, 2015.
    In a subsequent application, dated October 3, 2013, Monsanto has 
proposed to amend this permit (524-EUP-104) to plant MON 87411 in 
combination with other single- and combined-event PIPs that have been 
previously registered. The acreage to be planted under the proposed 
amendment over the 2-year period (2014-2016) are: 13,300 acres of event 
combinations containing MON 87411, 7,032 acres of other unregistered 
PIP combinations, 11,057 acres of registered PIPs to be used in 
comparators, and 14,653 acres of non-PIP and border plants.
    The PIP events comprising the single or combined trait products in 
this EUP include MON 89034, TC1507, MIR162, MON 88017, DAS-59122-7, and 
MON 87411. The proposed new corn event, MON 87411, contains a 
suppression cassette with an inverted repeat sequence (DvSnf7) derived 
from Diabrotica virgifera. The expression of the DvSnf7 suppression 
cassette results in the formation of a double stranded RNA (dsRNA) 
transcript. The researchers postulate that when PIP-produced Dv49 dsRNA 
is consumed by the pest, it down regulates the targeted pest's Snf7 
gene, resulting in CRW mortality. MON 87411 also produces the Cry3Bb1 
protein to protect against CRW larval feeding.
    The Bt proteins to be used in the single or combination traits in 
the proposed amended EUP include Cry1A.105, Cry2Ab2, Cry IF, Vip3Aa20, 
Cry3Bb1, and Cry34Abl/Cry35Abl. The environmental and human health 
safety of these proteins has been demonstrated, and they are 
respectively exempted from the requirement of a tolerance (40 CFR 
174.502, 174.519, 174.520, 174.501, 174.518, 174.506). A permanent 
tolerance exemption has been established for nucleic acids that are 
part of the PIPs proposed for testing, including the dsRNA from MON 
87411 (40 CFR 174.507).
    The tests will be conducted in the U.S. territory of Puerto Rico 
and in the states including: Alabama, Arkansas, California, Colorado, 
Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, 
Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, 
Nebraska, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, 
South Carolina, South Dakota, Tennessee, Texas, Washington and 
Wisconsin.
    Proposed protocols for 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.

    Authority:  7 U.S.C. 136c.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: December 30, 2013.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2014-00389 Filed 1-10-14; 8:45 am]
BILLING CODE 6560-50-P