[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13303-13304]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04520]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0033]


Stine Seed Farm, Inc.; Availability of Plant Pest Risk 
Assessment, Environmental Assessment, and Preliminary Decision for an 
Extension of a Determination of Nonregulated Status of Corn Genetically 
Engineered for Herbicide Tolerance

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 prepared a preliminary decision regarding a 
request from Stine Seed Farm, Inc., to extend to maize line HCEM485, 
which has been genetically engineered to be tolerant to the herbicide 
glyphosate, our determination of nonregulated status of Roundup 
Ready[supreg] corn line GA21. We are seeking comment on whether this 
genetically engineered corn is likely to pose a plant pest risk. We are 
making available for public comment our plant pest risk assessment and 
draft environmental assessment for the proposed determination of 
nonregulated status.

DATES: We will consider all comments that we receive on or before March 
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-2012-0033-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0033, 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-2012-033 
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 extension request, draft environmental assessment, and plant 
pest risk assessment are also available on the APHIS web site at http://www.aphis.usda.gov/brs/aphisdocs/09_06301p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/09_06301p_dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/09_06301p_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: john.t.turner@aphis.usda.gov. To obtain copies 
of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, 
email: cynthia.a.eck@aphis.usda.gov.

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 organisms (GE) 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 has 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. Stine Seed 
seeks a determination of nonregulated status of corn designated as 
maize line HCEM485, which has been genetically engineered to be 
glyphosate tolerant. 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 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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    As described in the extension request, maize line HCEM485 has been 
genetically engineered by a 6.0 kb corn genomic fragment, originally 
isolated from a bacterial chromosome library derived from the corn 
inbred line B73, containing a modified form of the endogenous Zea mays 
EPSPS encoding gene. The antecedent organism, Roundup Ready[supreg] 
corn line GA21, was made with a 1.3kb restriction fragment of the corn 
EPSPS gene. Both corn lines were produced with the same mutations 
responsible for conferring glyphosate herbicide tolerance. Maize line 
HCEM485 is currently regulated under 7 CFR part 340. Interstate 
movements and field tests of maize line HCEM485 have been conducted 
under 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 
whether the new variety poses a plant pest risk.

[[Page 13304]]

    In section 403 of the PPA, ``plant pest'' is defined as any living 
stage of any of the following that can directly or indirectly injure, 
cause damage to, or cause disease in any 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 prepared a plant pest 
risk assessment (PPRA) and has concluded that maize line HCEM485 is 
similar to the antecedent organism and 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 Stine Seed, 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 line HCEM485 and it would 
continue to be a regulated article, or (2) make a determination of 
nonregulated status of maize line HCEM485.
    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 
maize line HCEM485. 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); (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 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, and the similarity of 
maize line HCEM485 to the antecedent organism, Roundup Ready[supreg] 
corn line GA21, APHIS has determined that maize line HCEM485 is 
unlikely to pose a plant pest risk. We have therefore reached a 
preliminary decision to approve the request to extend the determination 
of nonregulated status of Roundup Ready[supreg] corn line GA21 to maize 
line HCEM485, whereby maize line HCEM485 would no longer be subject to 
our regulations governing the introduction of certain genetically 
engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of Roundup Ready[supreg] corn line GA21 to maize line HCEM485.
    APHIS will accept written comments on the draft EA and PPRA 
regarding a determination of nonregulated status of maize line HCEM485 
for a period of 30 days from the date this notice is published in the 
Federal Register. The draft EA and PPRA, as well as the extension 
request and preliminary determination for maize line HCEM485, are 
available for public review as indicated under ADDRESSES and FOR 
FURTHER INFORMATION CONTACT above. Copies of these documents may also 
be obtained by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    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 EA and PPRA will be 
available for public review. After reviewing and evaluating the 
comments on the EA and PPRA, APHIS will furnish a response to the 
petitioner regarding our final regulatory determination. APHIS will 
also publish a notice in the Federal Register announcing the regulatory 
status of maize line HCEM485 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. 2013-04520 Filed 2-26-13; 8:45 am]
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