Federal Register, Volume 75 Issue 8 (Wednesday, January 13, 2010)

[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Notices]
[Pages 1749-1751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-407]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2009-0072]

Syngenta Biotechnology, Inc.; Availability of Petition and
Environmental Assessment for Determination of Nonregulated Status for
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 for corn
designated as transformation event MIR162, which has been genetically
engineered for insect resistance. The petition has been submitted in
accordance with our regulations concerning the introduction of certain
genetically engineered organisms and products. In accordance with those
regulations, we are soliciting comments on whether this genetically
engineered corn is likely to pose a plant pest risk. We are also making
available for public comment an environmental assessment for the
proposed determination of nonregulated status.

DATES: We will consider all comments we receive on or before March 15,
2010.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0072) to submit or view comments
and to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2009-0072, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2009-0072.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room 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) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at (http://www.aphis.usda.gov).

FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0810, email: (subray.hegde@aphis.usda.gov). To
obtain copies of the petition, draft environmental assessment or plant
pest risk assessment, contact Ms. Cindy Eck at (301) 734-0667, email:
(cynthia.a.eck@aphis.usda.gov). Those documents are also available on
the Internet at (http://www.aphis.usda.gov/brs/aphisdocs/07_25301p.pdf), (http://

[[Page 1750]]

www.aphis.usda.gov/brs/aphisdocs/07_25301p_pea.pdf) and (http://www.aphis.usda.gov/brs/aphisdocs/07_25301p_pra.pdf).

SUPPLEMENTARY INFORMATION:

Background

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.
On September 10, 2007, APHIS received a petition seeking a
determination of nonregulated status (APHIS Petition Number 07-253-01p)
from Syngenta Biotechnology, Inc., of Research Triangle Park, NC
(Syngenta), for corn (Zea mays L.) designated as transformation event
MIR162, which has been genetically engineered for insect resistance,
stating that corn line MIR162 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, the MIR162 corn line has been
genetically engineered to express the VIP3Aa20 protein. The VIP3Aa20
gene is based on the sequences from Bacillus thuringiensis, a common
soil bacterium. The VIP3Aa20 gene confers tolerance to certain
lepidopteran (caterpillar) pests of corn. Expression of the VIP3Aa20
gene is driven by the corn ubiquitin promoter (ZmUbilnt), and uses the
terminator sequence from 35S RNA of cauliflower mosaic virus (CaMV).
MIR162 corn also contains the manA gene from E. coli, which encodes the
enzyme phosphomannose isomerase (PMI), and was used only as a
selectable marker during transformant selection and confers no other
benefits to the transformed corn plant. The manA gene is also driven by
the ZmUbilnt promoter, and uses the Nopaline Synthase (NOS) gene from
Agrobacterium tumefaciens as a terminator sequence. All of these
sequences are well-characterized and are non-coding regulatory regions
only. Therefore, these sequences will not cause the MIR162 corn line to
promote plant disease.
A single copy of these genes and other DNA regulatory sequences
were introduced into the corn genome with the transformation vector
pNOV1300 using disarmed (non-plant pest causing) A. tumefaciens
transformation. Plant cells containing the introduced DNA were selected
by culturing them in sugar mannose. After the initial transformation,
the antibiotic cefotoxime was included in the culture medium to kill
any remaining Agrobacterium. Therefore, no part of the plant pest A.
tumefaciens remained in Syngenta MIR162 corn due to the transformation
method.
Syngenta's MIR162 corn line has been considered a regulated article
under the regulations in 7 CFR part 340 because it contains gene
sequences from plant pathogens. The MIR162 corn line has been field
tested in the United States since 1999 as authorized by USDA APHIS
notifications and permits (see appendix A of the petition). In the
process of reviewing the permits for field trials of the subject corn,
APHIS determined that the vectors and other elements used to introduce
the new genes were disarmed and that the trials, which were conducted
under conditions of reproductive and physical confinement or isolation,
would not present a risk of plant pest introduction or dissemination.
Field tests conducted under USDA 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 data are used by APHIS to determine if the new
variety poses a plant pest risk. Syngenta has petitioned APHIS to make
a determination that the MIR162 corn line and the progeny derived from
its crosses with other nonregulated corn shall no longer be considered
regulated articles under 7 CFR part 340.
APHIS has prepared an 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 the MIR162 corn line and it would continue to be a regulated
article, or (2) grant nonregulated status to corn line MIR162 in whole.
In Sec. 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.),
``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.
The MIR162 corn line is subject to regulation by other Federal
agencies. The U.S. Environmental Protection Agency (EPA) is responsible
for the regulation of pesticides under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et
seq.). FIFRA requires that all pesticides, including herbicides, be
registered prior to distribution or sale, unless exempt from EPA
regulation. In order to be registered as a pesticide under FIFRA, it
must be demonstrated that when used with common practices, a pesticide
will not cause unreasonable adverse effects in the environment. Under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C.
301 et seq.), pesticides added to (or contained in) raw agricultural
commodities generally are considered to be unsafe unless a tolerance or
exemption from tolerance has been established. Residue tolerances for
pesticides are established by EPA under the FFDCA, and the U.S. Food
and Drug Administration (FDA) enforce the tolerances set by EPA.
Syngenta submitted the appropriate regulatory package to EPA on
November 2, 2007, seeking an exemption from the requirement of a
tolerance for residues from the Vip3Aa20 protein from B. thuringiensis.
On August 6, 2008, EPA granted the exemption.
FDA's policy statement concerning regulation of products derived
from new plant varieties, including those genetically engineered, was
published in the Federal Register on May 29, 1992 (57 FR 22984-23005).
Under this policy, FDA uses what is termed a consultation process to
ensure that human and animal feed safety issues or other regulatory
issues (e.g., labeling) are resolved prior to commercial distribution
of a bioengineered food. In compliance with the FDA policy, Syngenta
submitted a food and feed safety and nutritional assessment

[[Page 1751]]

summary to FDA for their MIR162 corn line in 2007. FDA completed their
consultation on MIR 162 corn on December 9, 2008, concluding that FDA
had ``no further questions concerning grain and forage derived from
corn event MIR162.''

National Environmental Policy Act

A 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 for
the MIR162 corn line. 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).
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 draft EA prepared
to examine any potential environmental impacts of the proposed
determination for the deregulation of the subject corn line, and the
plant pest risk assessment. The petition, draft EA, and plant pest risk
assessment are available for public review, and copies of the petition,
draft EA, and plant pest risk assessment 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 public comments received regarding the petition, draft
EA, and plant pest risk assessment will be available for public review.
After reviewing and evaluating the comments on the petition, the draft
EA, plant pest risk assessment and other data, APHIS will furnish a
response to the petitioner, either approving or denying the petition.
APHIS will then publish a notice in the Federal Register announcing the
regulatory status of the MIR162 corn line and the availability of
APHIS' written regulatory and environmental decision.

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 6\th\ day of January 2010.

Cindy Smith
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-407 Filed 1-12-10: 2:16 pm]
BILLING CODE 3410-34-S