[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41366-41367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17161]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0024]


Syngenta Biotechnology, Inc.; Availability of Petition, Plant 
Pest Risk Assessment, and Environmental Assessment for Determination of 
Nonregulated Status of Corn Genetically Engineered for Insect 
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 received a petition from Syngenta Biotechnology, 
Inc., seeking a determination of nonregulated status of corn designated 
as SYN-05307-1, which has been genetically engineered for resistance to 
corn rootworm, an insect pest of corn. The petition has been submitted 
in accordance with our regulations concerning the introduction of 
certain genetically engineered organisms and products. We are 
soliciting comments on whether this genetically engineered corn is 
likely to pose a plant pest risk. We are making available for public 
comment the Syngenta Biotechnology, Inc., petition, our plant pest risk 
assessment, and our draft environmental assessment for the proposed 
determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
September 11, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0024-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0024, 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-
0024 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, draft environmental assessment, and plant pest risk 
assessment are also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/10_33601p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/10_33601p_dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/10_33601p_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: [email protected]. To obtain copies 
of the petition, draft environmental assessment, or plant pest risk 
assessment, 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 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 10-336-01p) 
from Syngenta Biotechnology, Inc., (Syngenta) of Research Triangle 
Park, NC, seeking a determination of nonregulated status of corn (Zea 
mays L.) designated as event SYN-05307-1, which has been genetically 
engineered for resistance to corn rootworm, an insect pest of corn. The 
petition states that this corn 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, corn event SYN-05307-1 has been 
genetically engineered to contain the transgene ecry3.1Ab encoding a 
novel rootworm-control protein, eCry3.1Ab, and the transgene pmi (also 
known as manA) encoding the enzyme phosphomannose isomerase (PMI). The 
eCry3.1Ab protein is an engineered chimera of the modified Cry3A 
(mCry3A) and Cry1Ab proteins, members of a class of insecticidal 
proteins derived from Bacillus thuringiensis. Corn event SYN-05307-1 is 
currently regulated under 7 CFR part 340. Interstate movements and 
field tests of corn event SYN-05307-1 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 if the 
new variety poses 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

[[Page 41367]]

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 a plant pest 
risk assessment (PPRA) to determine if corn event SYN-05307-1 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 Syngenta, 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 corn event SYN-05307-1 and it would 
continue to be a regulated article, or (2) make a determination of 
nonregulated status of corn event SYN-05307-1.
    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 
corn event SYN-05307-1. 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), (3) USDA regulations implementing NEPA 
(7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR 
part 372).
    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 updated process for 
soliciting public comment when considering such petitions. As described 
in the notice, all petitions received by APHIS on or after March 6, 
2012, will be handled using the updated process, whereby APHIS will 
publish two separate notices in the Federal Register for petitions for 
which APHIS prepares an environmental assessment. For petitions 
received before this date, however, we indicated that petitions may 
follow our previous process, i.e., the petition, draft EA, and PPRA 
will be made available in a single Federal Register notice for a 60-day 
comment period. For this petition, APHIS is following that previous 
process.
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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, 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. We are also soliciting written 
comments from interested or affected persons on the PPRA and the draft 
EA prepared to examine any potential environmental impacts of the 
proposed determination for the deregulation of the subject corn line. 
The petition, draft EA, and PPRA are available for public review, and 
copies of the petition, draft EA, and PPRA are available as indicated 
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    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 petition, draft EA, 
and PPRA will be available for public review. After reviewing and 
evaluating the comments on the petition, the draft EA, PPRA, and other 
data, APHIS will furnish a response to the petitioner, either approving 
or denying the petition. APHIS will also publish a notice in the 
Federal Register announcing the regulatory status of corn event SYN-
05307-1 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 9th day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-17161 Filed 7-12-12; 8:45 am]
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