[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13305-13307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04521]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0090]


Syngenta Seeds, Inc., and Bayer CropScience AG; Availability of 
Petition for Determination of Nonregulated Status of Soybean 
Genetically Engineered for Herbicide Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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[[Page 13306]]

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has received a petition from Syngenta Seeds, 
Inc., and Bayer CropScience AG seeking a determination of nonregulated 
status of soybean designated as event SYHTOH2, which has been 
genetically engineered for tolerance to the herbicides glufosinate and 
mesotrione. The petition has been submitted in accordance with our 
regulations concerning the introduction of certain genetically 
engineered organisms and products. We are making the Syngenta Seeds, 
Inc., and Bayer CropScience AG petition available for review and 
comment to help us identify potential environmental and interrelated 
economic issues and impacts that APHIS may determine should be 
considered in our evaluation of the petition.

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-2012-0090-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0090, 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-
0090 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 is also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/12_21501p.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, 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 (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. 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 12-215-01p) 
from Syngenta Seeds, Inc., and Bayer CropScience (BCS) AG of Research 
Triangle Park, NC, seeking a determination of nonregulated status of 
soybean designated as event SYHTOH2, which has been genetically 
engineered to tolerate exposure to the herbicides glufosinate and 
mesotrione. Glufosinate tolerance is not a new engineered trait in GE 
soybean, while mesotrione tolerance is a new trait. The petition states 
that this soybean event 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, soybean event SYHTOH2 has been 
genetically engineered for tolerance to herbicides that inhibit p-
hydroxyphenylpyruvate dioxygenase (HPPD), such as mesotrione, and 
tolerance to applications of glufosinate-ammonium herbicide. Soybean 
derived from transformation event SYHTOH2 was developed through 
Agrobacterium-mediated transoformation to stably incorporate the genes 
avhppd-03 and pat into the soybean genome. The gene avhppd-03 encodes 
the enzyme p-hydroxyphenylpyruvate dioxygenase (AvHPPD-03) derived from 
oat (Avena sativa). AvHPPD-03 has lower binding affinity to mesotrione 
than does native soybean HPPD. When expressed in soybean, avhppd-03 
conveys pre-and post-emergence tolerance to mesotrione. The gene pat 
encodes the enzyme phosphinothricin acetyltransferase (PAT) which, when 
produced in plants, acetylates L-phosphinothricin, the active form of 
glufosinate-ammonium herbicide, resulting in post-emergence tolerance. 
Soybean event SYHTOH2 is currently regulated under 7 CFR part 340. 
Interstate movement and field tests of soybean event SYHTOH2 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 
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.
    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. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
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    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, 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. The petition is available for 
public review, and copies are available as indicated under ADDRESSES 
and FOR FURTHER INFORMATION CONTACT above.
    We are interested in receiving comments regarding potential 
environmental and interrelated economic issues and impacts that APHIS 
may determine should be considered in our evaluation of the petition. 
We are particularly interested in receiving comments regarding 
biological, cultural, or ecological issues,

[[Page 13307]]

and we encourage the submission of scientific data, studies, or 
research to support your comments. We also request that, when possible, 
commenters provide relevant information regarding specific localities 
or regions as soybean growth, crop management, and crop utilization may 
vary considerably by geographic region.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information; any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decisionmaking documents.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a plant pest risk assessment to 
assess its plant pest risk and the appropriate environmental 
documentation--either an environmental assessment (EA) or an 
environmental impact statement (EIS)--in accordance with the National 
Environmental Policy Act (NEPA), to provide the Agency with a review 
and analysis of any potential environmental impacts associated with the 
petition request. For petitions for which APHIS prepares an EA, APHIS 
will follow our published process for soliciting public comment (see 
footnote 1) and publish a separate notice in the Federal Register 
announcing the availability of APHIS' EA and plant pest risk 
assessment. Should APHIS determine that an EIS is necessary, APHIS will 
complete the NEPA EIS process in accordance with Council on 
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' 
NEPA implementing regulations (7 CFR part 372).

    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. 2013-04521 Filed 2-26-13; 8:45 am]
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