[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Pages 25941-25942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10510]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0033]


Stine Seed Farm, Inc.; Extension of a Determination of 
Nonregulated Status of Corn Genetically Engineered for Herbicide 
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 is extending to maize line HCEM485, which has been 
genetically engineered to be resistant to the herbicide glyphosate, our 
determination of nonregulated status of Roundup Ready[supreg] corn line 
GA21. Therefore, APHIS no longer considers maize line HCEM485 to be a 
regulated article under Agency regulations governing the introduction 
of certain genetically engineered organisms. Our decision is based on 
our evaluation of data submitted by Stine Seed Farm, Inc., in its 
request for an extension of a determination of nonregulated status, an 
analysis of other scientific data, and comments received from the 
public in response to a previous notice announcing our preliminary 
determination. This notice also announces the availability of our 
written determination, final environmental assessment, plant pest risk 
assessment, and our finding of no significant impact.

DATES: Effective Date: May 3, 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-2012-0033 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 09-063-01p Extension of 97-099-01p.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Stankiewicz Gabel, Chief, 
Biotechnology Environmental Analysis Branch, Environmental Risk 
Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3927, email: 
[email protected]. To obtain copies of the 
supporting documents, contact Ms. Cindy Eck at (301) 851-3885, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (PPA) (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 (GE) 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. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.
    In a notice published in the Federal Register on December 5, 1997 
(62 FR 64350-64351, Docket No. 97-052-2), APHIS announced our 
determination of nonregulated status of Roundup Ready[supreg] corn line 
GA21. APHIS received a request for an extension of a determination of 
nonregulated status (APHIS Number 09-063-01p) of Roundup Ready[supreg] 
corn line GA21 to maize line HCEM485 \1\ from Stine Seed Farm, Inc., 
(Stine Seed) of Research Triangle Park, NC. In its request, Stine Seed 
stated that this corn is similar to Roundup Ready[supreg] corn line 
GA21 and, based on the similarity to the antecedent organism, is 
unlikely to pose a plant pest risk and, therefore, should not be

[[Page 25942]]

a regulated article under APHIS' regulations in 7 CFR part 340.
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    \1\ The terms ``corn'' and ``maize'' both refer to Zea mays. In 
this notice, we refer to ``maize line HCEM485'' as this is the name 
used by Stine Seed in its extension request to identify its GE corn. 
Otherwise, we use the more common term ``corn'' when referring to 
Zea mays.
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    On February 27, 2013, APHIS published a notice \2\ in the Federal 
Register (78 FR 13303-13304, Docket No. APHIS-2012-0033) announcing the 
availability of a draft environmental assessment (EA) and plant pest 
risk assessment (PPRA) for public comment for the Stine Seed extension 
request. The extension request and APHIS' preliminary decision were 
also published with that notice. APHIS received three comments on the 
subject EA and PPRA during the designated 30-day public comment period, 
which ended March 29, 2013. Issues raised during the comment period 
included effects of glyphosate, pollen drift, crop diversity, and human 
health concerns. APHIS has addressed the issues raised during the 
comment period and has provided responses to these comments as an 
attachment to the finding of no significant impact (FONSI).
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    \2\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0033.
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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 maize line HCEM485, 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 scientific data, 
APHIS has reached a FONSI with regard to the preferred alternative 
identified in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Stine Seed, references provided in the extension request, peer-reviewed 
publications, information analyzed in the EA, the similarity of maize 
line HCEM485 to the antecedent organism, Roundup Ready[supreg] corn 
line GA21, comments provided by the public, and information provided in 
APHIS' response to those public comments, APHIS has determined that 
maize line HCEM485 is unlikely to pose a plant pest risk. We are 
therefore extending the determination of nonregulated status of Roundup 
Ready[supreg] corn line GA21 to maize line HCEM485, whereby maize line 
HCEM485 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 extension request, PPRA, EA, and FONSI 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 29th day of April 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-10510 Filed 5-2-13; 8:45 am]
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