[Federal Register Volume 72, Number 56 (Friday, March 23, 2007)]
[Notices]
[Pages 13736-13737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5345]


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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: 
[email protected]. 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]
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