[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]               
[Page 69602-69604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no08-37]                         

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0016]

 
Syngenta Seeds, Inc.; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Corn 
Genetically Engineered To Produce an Enzyme That Facilitates Ethanol 
Production

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 Seeds, Inc., 
seeking a determination of nonregulated status for corn designated as 
transformation event 3272, which has been genetically engineered to 
produce a microbial enzyme that facilitates ethanol production. 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 January 
20, 2009.

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-2007-0016 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-2007-0016, 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-2007-0016.

[[Page 69603]]

    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. Andrea Huberty, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 146, Riverdale, MD 
20737-1236; (301) 734-0485, e-mail: andrea.f.huberty@aphis.usda.gov. To 
obtain copies of the petition or the draft environmental assessment, 
contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
cynthia.a.eck@aphis.usda.gov. The petition and the draft environmental 
assessment are also available on the Internet at http://
www.aphis.usda.gov/brs/aphisdocs/05_28001p.pdf and http://
www.aphis.usda.gov/brs/aphisdocs/05_28001p_ea.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 October 7, 2005, APHIS received a petition seeking a 
determination of nonregulated status (APHIS Petition No. 05-280-01p) 
from Syngenta Seeds, Inc., of Research Triangle Park, NC (Syngenta), 
for corn (Zea mays L.) designated as transformation event 3272, which 
has been genetically engineered to produce a microbial enzyme that 
facilitates ethanol production. The petition stated that Event 3272 
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, Event 3272 corn has been genetically 
engineered to contain two transgenes: (1) The amy797E gene encoding the 
thermostable AMY797E alpha-amylase enzyme and (2) the pmi (manA) gene 
from Escherichia coli, which encodes the enzyme phosphomannose 
isomerase, used as a selectable marker. The AMY797E alpha-amylase 
enzyme is a chimeric, thermostable enzyme derived from three alpha-
amylase genes originating from three hyperthermophilic microorganisms 
of the archael order Thermococcales. The expression of amy797E is 
driven by the promoter from a corn seed storage (gamma-zein) gene, 
which directs the accumulation of alpha-amylase in the corn kernel. The 
pmi gene is from one of the main species of bacteria living in mammal 
intestines, E. coli, and is driven by the polyubiquitin promoter from 
corn.
    This genetic insert also contains the terminator sequences from two 
plant pests, cauliflower mosaic virus and Agrobacterium tumefaciens. 
Both of these sequences are well-characterized, and are noncoding 
regulatory regions only. These sequences will not cause Event 3272 corn 
to promote plant disease.
    DNA was introduced into corn cells from a proprietary corn line 
using disarmed (non-plant pest causing) Agrobacterium tumefaciens-
mediated transformation methodology with the transformation vector 
designated pNOV7013. Plant cells containing the introduced DNA were 
selected by culturing in the presence of mannose. After the initial 
transformation, broad-spectrum antibiotic cefotaxime was included in 
the culture medium to kill any remaining Agrobacterium. Therefore, no 
part of the plant pest A. tumefaciens is remaining in Event 3272 corn 
due to the transformation method.
    Event 3272 corn has been considered a regulated article under the 
regulations in 7 CFR part 340 because it contains gene sequences from 
plant pathogens. Event 3272 corn has been field-tested in the United 
States since 2002, as authorized by APHIS notifications and permits. 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 APHIS regulatory 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 field test data, in turn, are used by APHIS to 
determine whether the regulated corn event poses a plant pest risk. 
Syngenta has petitioned APHIS to make a determination that Event 3272 
corn and the progeny derived from its crosses with other nonregulated 
corn will no longer be considered regulated articles under 7 CFR part 
340.
    APHIS has prepared an environmental assessment (EA) in which it 
presents two alternatives for the determination of nonregulated status 
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 Event 3272 corn and it 
would continue to be a regulated article; or (2) the preferred 
alternative, grant nonregulated status to Event 3272 corn in whole. The 
EA also describes other alternatives that were initially evaluated but 
rejected from further consideration in the decision process for reasons 
explained in the EA.
    In section 403 of the Plant Protection Act (PPA) (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. APHIS views this PPA definition to cover 
direct or indirect injury, disease, or damage not just to agricultural 
crops, but also to other plants, for example, native species, as well 
as to plant parts and plant products whether natural, manufactured, or 
processed.
    Event 3272 corn is also subject to regulation by other Federal 
agencies. The Food and Drug Administration (FDA) policy statement 
concerning regulation of products derived from new plant varieties, 
including those

[[Page 69604]]

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 summary to FDA for Event 3272 corn which was 
completed in August 2007 acknowledging that based on the information 
available, Event 3272 corn did not raise safety or other issues that 
would require pre-market review or approval by the FDA. As Event 3272 
corn does not produce a pesticide or have a tolerance to any pesticide, 
the Environmental Protection Agency is not involved with evaluating 
Event 3272.

National Environmental Policy Act

    A draft EA has been prepared to inform the public of, and to 
provide the APHIS decisionmaker with, a review and analysis of 
potential environmental impacts associated with the proposed 
determination of nonregulated status for Event 3272 corn. 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 potential environmental impacts of the proposed 
determination for the deregulation of the subject corn line. The 
petition and the draft EA are available for public review, and copies 
of the petition and the draft EA are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will evaluate all written 
comments received during the comment period and any other relevant 
information. All public comments received regarding the petition and 
draft EA will be available for public review. After reviewing and 
evaluating the comments on the petition and the draft EA 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 Event 3272 corn 
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 13th day of November 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-27479 Filed 11-18-08; 8:45 am]

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