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[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37201-37202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14705]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0026]

Pioneer Hi-Bred International, Inc.; Determination of 
Nonregulated Status of Maize Genetically Engineered for Herbicide and 
Insect Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that a maize 
line developed by Pioneer Hi-Bred International Inc., designated as 
maize event DP-[Oslash][Oslash]4114-3, which has been genetically 
engineered to be resistant to certain lepidopteran and coleopteran 
pests and to the herbicide glufosinate, is no longer considered a 
regulated article under our regulations governing the introduction of 
certain genetically engineered organisms. Our determination is based on 
our evaluation of data submitted by Pioneer Hi-Bred International, 
Inc., in its petition for a determination of nonregulated status, our 
analysis of available scientific data, and comments received from the 
public in response to our previous notice announcing the availability 
of the petition for nonregulated status and its associated 
environmental assessment and plant pest risk assessment. This notice 
also announces the availability of our written determination and 
finding of no significant impact.

DATES: Effective Date: June 20, 2013.

ADDRESSES: Supporting documents, comments we received on our previous 
notice announcing our preliminary determination, and our responses to 
those comments 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. 
Supporting documents are also available on the APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions/_table_pending.shtml 
under APHIS petition Number 11-244-01p.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Stankiewicz Gabel, Chief, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3927, email: rebecca.l.stankiewicz-gabel@aphis.usda.gov. To 
obtain copies of the documents referred to in this notice, contact Ms. 
Cindy Eck at (301) 851-3892, email: cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: 

Background

    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 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 for maize (Zea mays) designated 
as maize event DP-[Oslash][Oslash]4114-3 (event 4114), which 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), as well as to the herbicide glufosinate. The 
petition stated 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.
    In a notice \1\ published in the Federal Register on February 27, 
2013 (78 FR 13312-13313, Docket No. APHIS-2012-0026), APHIS announced 
the availability of the Pioneer petition, a plant pest risk assessment 
(PPRA), and a draft environmental assessment (EA) for public comment. 
APHIS solicited comments on the petition, whether the subject maize is 
likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on April 29, 2013.
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    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0026.
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    APHIS received 12 comments during the comment period: Several of 
these comments included electronic attachments consisting of a 
consolidated document of identical letters for a total of 573 comments. 
Issues raised during the comment period include potential effects on 
human and animal health and non-target organisms, herbicide resistance, 
corn rootworm resistance, effects of stacked genes, and the length of 
the comment period. APHIS has addressed the issues raised during the 
comment period and has provided responses to comments as an attachment 
to the finding of no significant impact.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
determination of nonregulated status of Pioneer's maize event 4114, an 
EA has been prepared. The 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). Based on our EA, 
the response to public comments, and other pertinent

[[Page 37202]]

scientific data, APHIS has reached a finding of no significant impact 
with regard to the preferred alternative identified in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Pioneer, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, comments 
provided by the public, and information provided in APHIS' response to 
those public comments, APHIS has determined that Pioneer's maize event 
4114 is unlikely to pose a plant pest risk and therefore is no longer 
subject to our regulations governing the introduction of certain 
genetically engineered organisms.
    Copies of the signed determination document, as well as copies of 
the petition, PPRA, EA, finding of no significant impact, and response 
to comments, are available as indicated in the ADDRESSES and FOR 
FURTHER INFORMATION CONTACT sections of this notice.

    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 14th day of June 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-14705 Filed 6-19-13; 8:45 am]
BILLING CODE 3410-34-P
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