[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13312-13313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04518]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0026]


Pioneer Hi-Bred International, Inc.; Availability of Petition, 
Plant Pest Risk Assessment, and Environmental Assessment for 
Determination of Nonregulated Status of Maize Genetically Engineered 
for Herbicide Tolerance and Insect Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from Pioneer Hi-Bred 
International, Inc., (Pioneer) seeking a determination of nonregulated 
status of maize designated as maize event DP-[Oslash][Oslash]4114-3, 
which has been genetically engineered to be resistant to certain 
lepidopteran and coleopteran pests and tolerant to the herbicide 
glufosinate. The petition has been submitted in accordance with our 
regulations concerning the introduction of certain genetically 
engineered organisms and products. We are soliciting comments on 
whether this genetically engineered maize is likely to pose a plant 
pest risk. We are making available for public comment the Pioneer 
petition, our plant pest risk assessment, and our draft environmental 
assessment for the proposed determination of nonregulated status.

DATES: We will consider all comments that we receive on or before April 
29, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0026-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0026, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-
0026 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.
    The petition, draft environmental assessment, and plant pest risk 
assessment are also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/11_24401p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/11_24401p _dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/11_24401p _dpra.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, email: [email protected]. To obtain copies 
of the petition, draft environmental assessment, or plant pest risk 
assessment, contact Ms. Cindy Eck at (301) 851-3892, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 
340, ``Introduction of Organisms and Products Altered or Produced 
Through Genetic Engineering Which Are Plant Pests or Which There Is 
Reason to Believe Are Plant Pests,'' regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products altered or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests. Such genetically engineered organisms and 
products are considered ``regulated articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Paragraphs (b) and (c) of Sec.  340.6 describe 
the form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    APHIS has received a petition (APHIS Petition Number 11-244-01p) 
from Pioneer Hi-Bred International, Inc., (Pioneer) of Johnston, IA, 
seeking a determination of nonregulated status of maize (Zea mays) 
designated as maize event DP-[Oslash][Oslash]4114-3 (event 4114). Event 
4114 has been genetically engineered to be resistant to certain 
lepidopteran pests, including European corn borer (Ostrinia nubilalis), 
and certain coleopteran pests, including western corn rootworm 
(Diabrotica virgifera virgifera), and tolerant to the herbicide 
glufosinate. The petition states that this maize is unlikely to pose a 
plant pest risk and, therefore, should not be a regulated article under 
APHIS' regulations in 7 CFR part 340.
    As described in the petition, event 4114 has been genetically 
engineered to produce the Cry proteins Cry1F, Cry34Ab1, and Cry35Ab1, 
as well as the herbicide tolerance protein phosphinothricin 
acetyltransferase (PAT). The Cry1F protein confers resistance to 
certain lepidopteran pests, including European corn borer; the Cry34Ab1 
and Cry35Ab1 proteins confers resistance to certain coleopteran pests, 
including the western corn rootworm; and the PAT protein confers 
tolerance to the herbicidal active ingredient glufosinate-ammonium at 
current labeled rates. Event 4114 is currently regulated under 7 CFR 
part 340. Interstate movements and field tests of event 4114 have been 
conducted under permits issued or notifications acknowledged by APHIS.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the risk of persistence in the environment after completion of the 
test. Data are gathered on multiple parameters and used by the 
applicant to evaluate agronomic characteristics and product 
performance. These and other data are used by APHIS to determine if the 
new variety poses a plant pest risk.
    In section 403 of the Plant Protection Act, ``plant pest'' is 
defined as any

[[Page 13313]]

living stage of any of the following that can directly or indirectly 
injure, cause damage to, or cause disease in any plant or plant 
product: A protozoan, a nonhuman animal, a parasitic plant, a 
bacterium, a fungus, a virus or viroid, an infectious agent or other 
pathogen, or any article similar to or allied with any of the 
foregoing. APHIS has prepared a plant pest risk assessment to determine 
if event 4114 is unlikely to pose a plant pest risk.
    APHIS has also prepared a draft environmental assessment (EA) in 
which it presents two alternatives based on its analyses of data 
submitted by Pioneer, a review of other scientific data, and field 
tests conducted under APHIS oversight. APHIS is considering the 
following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of maize event 4114 and it would continue 
to be a regulated article, or (2) make a determination of nonregulated 
status of event 4114.
    The draft EA has been prepared to provide the APHIS decisionmaker 
with a review and analysis of any potential environmental impacts 
associated with the proposed determination of nonregulated status of 
event 4114. The draft EA was prepared in accordance with (1) the 
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 
4321 et seq.), (2) regulations of the Council on Environmental Quality 
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. In accordance 
with Sec.  340.6(d) of the regulations, we are publishing this notice 
to inform the public that APHIS will accept written comments regarding 
the petition for a determination of nonregulated status from interested 
or affected persons for a period of 60 days from the date of this 
notice. We are also soliciting written comments from interested or 
affected persons on the plant pest risk assessment and the draft EA 
prepared to examine any potential environmental impacts of the proposed 
determination of nonregulated status of the subject maize line. The 
petition, draft EA, and plant pest risk assessment are available for 
public review, and copies of the petition, draft EA, and plant pest 
risk assessment are available as indicated under ADDRESSES and FOR 
FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments received regarding the petition, draft EA, 
and plant pest risk assessment will be available for public review. 
After reviewing and evaluating the comments on the petition, the draft 
EA, plant pest risk assessment, and other data, APHIS will furnish a 
response to the petitioner, either approving or denying the petition. 
APHIS will also publish a notice in the Federal Register announcing the 
regulatory status of event 4114 and the availability of APHIS' written 
environmental decision and regulatory determination.

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 22nd day of February 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology Regulatory Services, Animal and 
Plant Health Inspection Service.
[FR Doc. 2013-04518 Filed 2-26-13; 8:45 am]
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