[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31079-31080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12554]


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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 
Plant Pest Risk Assessment, Environmental Assessment, Preliminary 
Finding of No Significant Impact, and Preliminary Determination of 
Nonregulated Status of Soybean 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 has prepared a preliminary determination regarding a 
request from Syngenta Seeds, Inc., and Bayer CropScience AG seeking a 
determination of nonregulated status of soybean designated as SYHTOH2, 
which has been genetically engineered for resistance to the herbicide 
glufosinate and p-hydroxyphenylpyruvate dioxygenase inhibiting 
herbicides such as isoxaflutole and mesotrione. We are also making 
available for public review our plant pest risk assessment, 
environmental assessment, and preliminary finding of no significant 
impact for the preliminary determination of nonregulated status.

DATES: We will consider any information that we receive on or before 
June 30, 2014.

ADDRESSES: You may submit any information by either of the following 
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0090.
     Postal Mail/Commercial Delivery: Send your information 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 for this petition and any other information 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.
    Supporting documents for this petition are also available on the 
APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 12-215-01p.

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 supporting documents for this petition, contact Ms. Cindy Eck at 
(301) 851-3892, email: [email protected].

SUPPLEMENTARY INFORMATION: 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. APHIS received a petition (APHIS Petition Number 
12-215-01p) from Syngenta Seeds, Inc., (Syngenta) and Bayer CropScience 
AG (BCS) of Research Triangle Park, NC, seeking a determination of 
nonregulated status of soybean (Glycine max) designated as event 
SYHTOH2, which has been genetically engineered to withstand exposure to 
the herbicide glufosinate and p-hydroxyphenylpyruvate dioxygenase 
inhibiting herbicides such as isoxaflutole and mesotrione. The petition 
states that this soybean is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
    According to our process \1\ for soliciting public input when 
considering petitions for determinations of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. In a notice \2\ published in the Federal 
Register on February 27, 2013, (78 FR 13305-13307, Docket No. APHIS-
2012-0090), APHIS announced the availability of the Syngenta/BCS 
petition for public comment. APHIS solicited comments on the petition 
for 60 days ending on April 29, 2013, in order to help identify 
potential environmental and interrelated economic impacts that APHIS 
may determine should be considered in our evaluation of the petition.
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    \1\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for GE organisms. To view the notice, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \2\ To view the notice, the petition, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2012-0090.
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    APHIS received 28 comments on the petition. Several of these 
comments included electronic attachments consisting of many identical 
or nearly identical letters, for a total of 584 comments. Issues raised 
during the comment period include concerns regarding the development of 
herbicide-resistant weeds, potential impacts on organic farmers, and 
health concerns. APHIS has evaluated the issues raised during the 
comment period and, where appropriate, has provided a discussion of 
these issues in our environmental assessment (EA).
    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public input process (see footnote 1), the second opportunity for 
public involvement follows one of two approaches, as described below.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises no substantive new issues, APHIS will follow 
Approach 1 for public involvement. Under Approach 1, APHIS announces in 
the Federal Register the availability of

[[Page 31080]]

APHIS' preliminary regulatory determination along with its EA, 
preliminary finding of no significant impact (FONSI), and its plant 
pest risk assessment (PPRA) for a 30-day public review period. APHIS 
will evaluate any information received related to the petition and its 
supporting documents during the 30-day public review period. For this 
petition, we are using Approach 1.
    Alternatively, if APHIS decides, based on its review of the 
petition and its evaluation and analysis of comments received during 
the 60-day public comment period on the petition, that the petition 
involves a new crop-trait GE organism or raises substantive new issues, 
APHIS will follow Approach 2. Under Approach 2, APHIS first solicits 
written comments from the public on a draft EA and a PPRA for a 30-day 
comment period through the publication of a Federal Register notice. 
Then, after reviewing and evaluating the comments on the draft EA and 
the PPRA and other information, APHIS will revise the PPRA as necessary 
and prepare a final EA and, based on the final EA, a National 
Environmental Policy Act (NEPA) decision document (either a FONSI or a 
notice of intent to prepare an environmental impact statement).
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a PPRA to assess the plant pest risk 
of the article. APHIS also prepares the appropriate environmental 
documentation--either an EA or an environmental impact statement--in 
accordance with NEPA, to provide the Agency and the public with a 
review and analysis of any potential environmental impacts that may 
result if the petition request is approved.
    APHIS has prepared a PPRA and has concluded that soybean event 
SYHTOH2 is unlikely to pose a plant pest risk. In section 403 of the 
Plant Protection Act, ``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 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 an EA in which we present two alternatives based 
on our analysis of data submitted by Syngenta/BCS, a review of other 
scientific data, field tests conducted under APHIS oversight, and 
comments received on the petition. APHIS is considering the following 
alternatives: (1) Take no action, i.e., APHIS would not change the 
regulatory status of soybean event SYHTOH2 and it would continue to be 
a regulated article, or (2) make a determination of nonregulated status 
of soybean event SYHTOH2. APHIS' preferred alternative is to make a 
determination of nonregulated status of soybean event SYHTOH2.
    The EA was prepared in accordance with (1) 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 and other pertinent scientific data, APHIS has reached 
a preliminary FONSI with regard to the preferred alternative identified 
in the EA.
    Based on APHIS' analysis of field and laboratory data submitted by 
Syngenta/BCS, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, comments 
provided by the public on the petition, and discussion of issues in the 
EA, APHIS has determined that soybean event SYHTOH2 is unlikely to pose 
a plant pest risk. We have therefore reached a preliminary decision to 
make a determination of nonregulated status of soybean event SYHTOH2, 
whereby soybean event SYHTOH2 would no longer be subject to our 
regulations governing the introduction of certain GE organisms.
    We are making available for a 30-day review period APHIS' 
preliminary regulatory determination of soybean event SYHTOH2, along 
with our PPRA, EA, and preliminary FONSI for the preliminary 
determination of nonregulated status. The PPRA, EA, preliminary FONSI, 
and our preliminary determination for soybean event SYHTOH2, as well as 
the Syngenta/BCS petition and the comments received on the petition, 
are available as indicated under ADDRESSES and FOR FURTHER INFORMATION 
CONTACT above. Copies of these documents may also be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT.
    After the 30-day review period closes, APHIS will review and 
evaluate any information received during the 30-day review period. If, 
after evaluating the information received, APHIS determines that we 
have not received substantive new information that would warrant APHIS 
altering our preliminary regulatory determination or FONSI, 
substantially changing the proposed action identified in the EA, or 
substantially changing the analysis of impacts in the EA, APHIS will 
notify the public through an announcement on our Web site of our final 
regulatory determination. If, however, APHIS determines that we have 
received substantive new information that would warrant APHIS altering 
our preliminary regulatory determination or FONSI, substantially 
changing the proposed action identified in the EA, or substantially 
changing the analysis of impacts in the EA, then APHIS will notify the 
public of our intent to conduct additional analysis and to prepare an 
amended EA, a new FONSI, and/or a revised PPRA, which would be made 
available for public review through the publication of a notice of 
availability in the Federal Register. APHIS will also notify the 
petitioner.

    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 23rd day of May 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-12554 Filed 5-29-14; 8:45 am]
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