[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41366-41367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17161]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: john.t.turner@aphis.usda.gov. To obtain copies
of the petition, draft environmental assessment, or plant pest risk
assessment, contact Ms. Cindy Eck at (301) 851-3892, email:
cynthia.a.eck@aphis.usda.gov.
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.
---------------------------------------------------------------------------
\1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------
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]
BILLING CODE 3410-34-P