E7-5345. 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.

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 [phone] 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; [phone]. To obtain copies of the petition or the environmental assessment (EA) and finding of no significant impact (FONSI), contact Ms. Cynthia Eck at [phone], e-mail: [e-mail]. 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 § 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 § 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 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.