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Syngenta Seeds, Inc.; Availability of Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: March 23, 2007 (Volume 72, Number 56)]
[Notices]
[Page 13736-13737]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr07-29]

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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2006-0157]

Syngenta Seeds, Inc.; Availability of 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 of our determination that a corn
line developed by Syngenta, designated as transformation event MIR604,
which has been genetically engineered for resistance to corn rootworm,
is no longer considered a regulated article under our regulations
governing the introduction of certain genetically engineered organisms.
Our determination is based on our evaluation of data submitted by
Syngenta Seeds, Inc., in their petition for a determination of
nonregulated status, our analysis of other scientific data, and
comments received from the public in response to a previous notice
announcing the availability of the petition for nonregulated status and
an environmental assessment. This notice also announces the
availability of our written determination and our finding of no
significant impact.

DATES: Effective Date: March 16, 2007.

ADDRESSES: You may read the petition, the environmental assessment, the
determination, the finding of no significant impact, the comments we
received on our previous notice, and our responses to those comments 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. To view those documents on
the Internet, go to http://www.regulations.gov, click on the ``Advanced
Search'' tab, and select ``Docket Search.'' In the Docket ID field,
enter APHIS-2006-0157, then click ``Submit.'' Clicking on the Docket ID
link in the search results page will produce a list of all documents in
the docket.

FOR FURTHER INFORMATION CONTACT: Dr. Catherine Preston, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5874. To obtain copies of the petition or the
environmental assessment (EA) and finding of no significant impact
(FONSI), contact Ms. Cynthia Eck at (301) 734-0667, e-mail: 
cynthia.a.eck@aphis.usda.gov. The petition, EA, and FONSI are also
available on the Internet at: 
http://www.aphis.usda.gov/brs/aphisdocs/04_36201p.pdf and 
http://www.aphis.usda.gov/brs/aphisdocs/04_36201p_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 December 24, 2004, APHIS received a petition (APHIS No. 04-362-
01p) from Syngenta Seeds, Inc. (Syngenta) of Research Triangle Park,
NC, requesting a determination of nonregulated status under 7 CFR part
340 for corn (Zea mays L.) designated as transformation event MIR604,
which has been genetically engineered for resistance to corn rootworm
(CRW). In response to APHIS' subsequent requests for additional
information and clarification, Syngenta submitted a revised final
petition on August 2, 2006. The Syngenta petition states that the
subject corn should not be regulated by APHIS because it does not
present a plant pest risk.

Analysis

    As described in the petition, corn transformation event MIR604 has
been genetically engineered to express two transgenes: (1) The modified
cry3A (mcry3A) gene derived from a well-characterized gene sequence
from Bacillus thuringiensis, encoding the mCRY3A insect control protein
and (2) the pmi (manA) gene from Escherichia coli, which encodes the
enzyme phosphomannose isomerase (PMI) for use as a selectable marker.
Expression of the mcry3A gene by corn plants renders the corn line
resistant to CRW. Regulatory elements for the mcry3A and pmi genes were
derived from maize and Agrobacterium tumefaciens. These regulatory
sequences are not transcribed and do not encode proteins. The DNA was
introduced into corn cells using Agrobacterium-mediated transformation
methodology with the T-DNA transformation vector designated pZM26. In
addition to transgenes necessary for insertion into the plant genome,
the T-DNA vector also contained two additional genetic elements: (1) A
gene conferring bacterial resistance to the antibiotics erythromycin,
streptomycin, and spectinomycin and (2) the bacterial origin of
replication. Plant cells containing the introduced DNA were then
selected by culturing in the presence of mannose. After the initial
incubation with Agrobacterium, the broad-spectrum antibiotic cefotaxime
was included in the culture medium to kill any remaining Agrobacterium.
    In a notice published in the Federal Register on January 10, 2007
(72 FR 1212-1214, Docket No. APHIS-2006-0157), APHIS announced the
availability of the Syngenta petition and an environmental assessment
(EA). APHIS solicited comments on whether the subject corn would
present a plant pest risk for 60 days ending on March 12, 2007, and on
the EA for 30 days ending on February 9, 2007. In order to provide
interested persons additional time to prepare and submit comments on
the draft EA, APHIS extended the comment period for the EA until March
9, 2007, i.e., the date 15 days after the publication of our notice of
extension. APHIS received 14 comments on the EA and 27 comments on the
petition by the close of their respective comment periods. There were
20 comments submitted in support of the petition to grant nonregulated
status to MIR604 corn and 7 that were opposed. With regard to the EA
prepared by APHIS to examine the potential environmental impacts of
granting nonregulated status to MIR604 corn, there were seven

[[Page 13737]]

comments submitted in support of the conclusions drawn in the EA and
seven comments opposed to the conclusions drawn in the EA. APHIS'
responses to these comments can be found in an attachment to the
finding of no significant impact (FONSI).

Determination

    Based on APHIS' analysis of field, greenhouse, and laboratory data
submitted by Syngenta, references provided in the petition, other
relevant information described in the EA, and comments provided by the
public, APHIS has determined that MIR604 will not pose a plant pest
risk for the following reasons: (1) Gene introgression from MIR604 corn
into wild relatives in the United States and its territories is
extremely unlikely and is not likely to increase the weediness
potential of any resulting progeny nor adversely affect genetic
diversity of related plants any more than would introgression from
traditional corn hybrids; (2) it exhibits no characteristics that would
cause it to be weedier than the non-genetically engineered parent corn
line or other cultivated corn; (3) it does not pose a risk to non-
target organisms, including beneficial organisms and threatened or
endangered species, because the insecticidal activity of the mCry3A
protein is limited to target pest species, namely corn rootworm; (4) it
does not pose a threat to biodiversity as it does not exhibit traits
that increase its weediness and its unconfined cultivation should not
lead to increased weediness of other cultivated corn, it exhibits no
changes in disease susceptibility, and it is unlikely to harm non-
target organisms common to the agricultural ecosystem or threatened or
endangered species recognized by the U.S. Fish and Wildlife Service;
(5) compared to current corn pest and weed management practices,
cultivation of MIR604 corn should not impact standard agricultural
practices in corn cultivation and controlling volunteer corn, including
those for organic farmers; and (6) disease susceptibility and
compositional profiles of MIR604 corn are similar to those of its
parent variety and other corn cultivars grown in the United States,
therefore no direct or indirect plant pest effects on raw or processed
plant commodities are expected.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
determination of nonregulated status for MIR604, an EA was prepared.
The 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). Based on that EA, APHIS has
reached a FONSI with regard to the determination that Syngenta corn
line MIR604 and lines developed from it are no longer regulated
articles under its regulations in 7 CFR part 340. Copies of the EA and
FONSI are available as indicated in the ADDRESSES and FOR FURTHER
INFORMATION CONTACT sections of this notice.

    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 20th day of March 2007.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-5345 Filed 3-22-07; 8:45 am]
BILLING CODE 3410-34-P

 
 

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