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Pioneer Hi-Bred International, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Genetically Engineered High-Oleic Soybeans

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Animal and Plant Health Inspection Service, USDA.




We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Pioneer Hi-Bred International, Inc., seeking a determination of nonregulated status for soybean designated as transformation Start Printed Page 45414event 305423, which has been genetically engineered to have higher levels of oleic acid, and lower levels of linoleic and linolenic acids in the soybean oil. 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 soybean is or could be a plant pest. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.


We will consider all comments we receive on or before November 2, 2009.


You may submit comments by either of the following methods:

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

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Mrs. Karen Green, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0672, e-mail: To obtain copies of the petition or the draft environmental assessment, contact Ms. Cindy Eck at (301) 734-0667, e-mail: The petition, the draft environmental assessment, and the plant pest risk assessment are also available on the Internet at​brs/​aphisdocs/​06_​35401p.pdf,​brs/​aphisdocs/​06_​35401p_​ea.pdf, and​brs/​aphisdocs/​06_​35401p_​pra.pdf.

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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 20, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition No. 06-354-01p) from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer), for soybean (Glycine max L.) designated as transformation event 305423, which has been genetically engineered for higher levels of oleic acid, a monounsaturated fat in soybean oil, stating that soybean line 305423 does not present 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, 305423 soybean has been genetically engineered to suppress the expression of the soybean endogenous microsomal omega-6 desaturases gene (FAD2-1). The introduced endogenous FAD2-1 gene fragment acts to silence expression of the endogenous FAD2-1 gene, which is responsible for an increased level of oleic acid and decreased levels of linoleic acid, a major polyunsaturated fatty acid present in soybean oil.

In addition, Pioneer 305423 soybean contains a slightly modified version of an endogenous acetolactate synthase gene (ALS). Expression of the protein can increase the inherent tolerance level to the ALS-inhibiting class of herbicides. This trait is intended for selecting and identifying this bioengineered event, rather than as a separate commercial trait as this version of the gene does not confer commercial levels of herbicide tolerance in Pioneer 305423 soybean.

APHIS has prepared an environmental assessment (EA) that presents two alternatives based on APHIS' analyses of data submitted by Pioneer, a review of other scientific data, and information obtained during field tests conducted under APHIS oversight. APHIS may either: (1) Take no action, i.e., APHIS would not change the regulatory status of 305423 soybeans and they would continue to be regulated articles, or (2) deregulate 305423 soybeans in whole.

Section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), defines “plant pest” 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 plant pest 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.

The 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. Pioneer submitted a food and feed safety and nutritional assessment summary to the FDA for 305423 soybeans. On January 15, 2009, the FDA concluded their review of the data submitted by Pioneer and had no further questions regarding the safety of 305423 soybean.

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 305423 soybeans, an EA has been prepared. The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 Start Printed Page 45415(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 7 CFR 340.6(d), 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. During the same comment period, we are also soliciting written comments from interested or affected persons on the plant pest risk assessment and on the EA prepared to examine any environmental impacts of the proposed deregulation determination for the subject soybean event. The petition, plant pest risk assessment, EA, and any comments we receive are available for public review, and copies of the petition, plant pest risk assessment, and 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 60-day comment period and any other relevant information. All public comments received regarding the petition, plant pest risk assessment, and draft EA will be available for public review. After reviewing and evaluating the comments on the petition, plant pest risk assessment, draft EA, and other data, APHIS will furnish a response to the petitioner, either approving in whole or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Pioneer's 305423 soybean and the availability of APHIS' written decision.

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Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.8, and 371.3.

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Done in Washington, DC, this 26th day of August 2009.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. E9-21277 Filed 8-31-09; 11:15 am]