2010-407. 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.

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 [phone] 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; [phone], email: ([e-mail]). To obtain copies of the petition, draft environmental assessment or plant pest risk assessment, contact Ms. Cindy Eck at [phone], email: ([e-mail]). Those documents are also available on the Internet at (http://www.aphis.usda.gov/​brs/​aphisdocs/​07_​25301p.pdf), (http://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 § 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 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 § 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 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 § 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.