E7-24174. Monsanto Company; 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 the Monsanto Company seeking a determination of nonregulated status for insect-resistant corn derived from a transformation event designated as MON 89034. 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 or could be a plant pest. 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 we receive on or before February 11, 2008.

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-2007-0030 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-2007-0030, 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-2007-0030.

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. Robyn Rose, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone], e-mail: [e-mail]. To obtain copies of the petition or the environmental assessment, contact Ms. Cindy Eck at [phone], e-mail: [e-mail]. The petition and the environmental assessment are also available on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​29801p.pdf and http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​29801p_​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 October 26, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS No. 06-298-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, for corn (Zea mays L.) designated as transformation event MON 89034, which has been genetically engineered for resistance to European corn borer (ECB) and other lepidopteran pests, stating that corn line MON 89034 does not present a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340. Monsanto responded to APHIS' subsequent request for additional information and clarification and submitted an addendum to their petition on January 23, 2007. The petition is available for public review and comment.

Analysis

As described in the petition, corn transformation event MON 89034 has been genetically engineered to express the transgenes cry1A.105 and cry2Ab2, both of which were derived from a well-characterized gene sequence from Bacillus thuringiensis, and encode insect control proteins. The neomycin phosphotransferase II (nptII) gene was used as a selectable marker, but was eliminated by traditional breeding methods in the later stages of development of MON 89034. Thus, MON 89034 contains only the cry1A.105 and cry2Ab2 expression cassettes. Expression of the transgenes by corn plants renders the corn line resistant to European corn borer, as well as other lepidopteran pests. Regulatory elements for the transgenes were obtained from 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 binary transformation vector designated PV-ZMIR245.

Transformation event MON 89034 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. MON 89034 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 two alternatives in the draft environmental assessment (EA) based on its analyses of data submitted by Monsanto, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS may: (1) Take no action (MON 89034 remains a regulated article), or (2) deregulate MON 89034.

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 to plant parts and plant products whether natural, manufactured, or processed.

MON 89034 corn 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 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. On July 17, 2006, the EPA announced a temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1A.105 protein and the genetic material necessary for its production in corn on field corn, sweet corn, and popcorn when applied/used as a plant-incorporated protectant (PIP). The temporary tolerance exemption will expire on June 30, 2009 (71 FR 40427-40431). On July 17, 2006, EPA announced a temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry2Ab2 protein and the genetic material necessary for its production in corn on field corn, sweet corn, and popcorn when applied/used as a PIP. The temporary tolerance exemption will expire on June 30, 2009 (71 FR 40431-40436). Pursuant to its authority under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.), EPA conducted a comprehensive assessment of the Cry1A.105 and Cry2Ab2 proteins 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.

Under the FFDCA, 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. Monsanto submitted a summary of their safety assessment to the FDA on October 13, 2006. The FDA consultation for MON 89034 corn as food and feed is currently underway.

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 MON 89034. 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 environmental impacts of the proposed determination for the deregulation of 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 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. 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 or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Monsanto's insect-resistant corn event MON 89034 and the availability of APHIS' written regulatory and environmental decisions.

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 7th day of December 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.