Syngenta; 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 Seeds, Inc., seeking a determination of nonregulated status for corn rootworm-resistant corn derived from a transformation event designated as MIR604. 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 corn presents a plant pest risk. We are also making available for public comment a draft environmental assessment for the proposed determination of nonregulated status.

DATES:

We will consider all comments on the petition that are received on or before March 12, 2007. We will consider all comments on the draft environmental assessment that are received on or before February 9, 2007.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov , select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0157 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0157, 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-2006-0157.

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. Catherine Preston, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5874, e-mail: catherine.a.preston@aphis.usda.gov. To obtain copies of the petition or the environmental assessment, contact Mr. Steve Bennett at (301) 734-5672, e-mail: steven.m.bennett@aphis.usda.gov. The petition and the environmental assessment 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 27, 2004, APHIS received a request seeking a determination of nonregulated status (APHIS No. 04-362-01p) from Syngenta Seeds, Inc. (Syngenta) of Research Triangle Park, NC, for corn (Zea mays L.) designated as transformation event MIR604, which has been genetically engineered for resistance to corn rootworm (CRW), stating that corn line MIR604 does not present a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340. Syngenta responded to APHIS' subsequent request for additional information and clarification and submitted a revised petition on May 17, 2006. Another request for information and clarification was sent to Syngenta on July 25, 2006. Syngenta subsequently revised and resubmitted their petition and response to APHIS' request on August 2, 2006. The final two versions of the petition, submitted on May 17, 2006, and August 2, 2006, as well as Syngenta's written responses to APHIS' request sent on July 25, 2006, are available for public review and comment.

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.

Transformation event MIR604 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. MIR604 corn has been field tested in the United States since 2001 under notifications and permits authorized by the U.S. Department of Agriculture (USDA). APHIS has presented three alternatives in the draft environmental assessment (EA) based on its analyses of data submitted by Syngenta, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS may: (1) Take no action, (2) deregulate MIR604, or (3) deregulate MIR604 in part.

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. APHIS views this definition broadly 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 organisms that may be beneficial to plants, such as honeybees.

MIR604 corn is subject to regulation by other 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 cases in which genetically engineered plants allow for a new use of a pesticide or involve a different use pattern for the pesticide, EPA must approve the new or different use. Accordingly, Syngenta submitted two petitions to the EPA, which announced its receipt of the petitions in two notices published in the Federal Register on October 27, 2004. The first petition requested an exemption from tolerance from the requirement of a tolerance for residues of the mCRY3A protein and the genetic material necessary for their production in corn (69 FR 62688-62692), and the second was an application to register a pesticide product containing a new active ingredient (69 FR 62678-62680). On April 6, 2005, a temporary tolerance exemption was granted for residues of the mCRY3A protein and the genetic material necessary for their production in corn, concluding that there was a reasonable certainty of no harm from consumption of the protein, as it is digestible in gastric fluid and not considered an allergen (70 FR 17323-17327). This temporary exemption was subsequently renewed (69 FR 11431-11433) and is currently set to expire on October 15, 2007 (71 FR 13269-13274). On January 25, 2006, EPA announced the receipt of an application filed by Syngenta to amend an application for an Experimental Use Permit (EUP) to include the plant-incorporated protectant Event MIR604 mCry3A corn (71 FR 4141-4142). Also on January 25, 2006, EPA announced Syngenta applied for an extension to the tolerance exemption expiring on October 15, 2006 (69 FR 11431-11433). On January 25, 2006, the EPA announced a 2-day meeting (March 14-15, 2006) for the FIFRA Scientific Advisory Panel to consider and review human health and environmental issues associated with MIR604 Modified Cry3A Protein Bt Corn-Plant Incorporated Protectant (71 FR 4130-4133).

Under the Federal Food, Drug, and Cosmetic Act (FFDCA) (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 Food and Drug Administration (FDA) enforces tolerances set by EPA under the FFDCA.

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. Syngenta submitted a summary of their safety assessment on February 25, 2005, and additional information on March 21, 2006. The Syngenta assessment submitted to the FDA indicated no changes in composition, safety, or other relative parameters. The consultation process for MIR604 corn as food and feed is nearing completion.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status for MIR604, a draft EA has been prepared. 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)(2), 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 for a period of 30 days from the date of this notice on the EA prepared to examine any environmental impacts of the proposed determination for the subject corn event. The petition, the draft EA, and any comments received are available for public review, and copies of the petitions and the draft EA are available as indicated in the FOR FURTHER INFORMATION CONTACT section of this notice.

After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. After reviewing and evaluating the comments on the petition and the EA and other data and information, APHIS will furnish a response to the petitioner, either approving the petition in whole or in part, or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Syngenta's insect-resistant corn event MIR604 and the availability of APHIS' written 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.