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Pioneer Hi-Bred International, Inc.; 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 of our determination that a soybean line developed by Pioneer Hi-Bred International, designated as transformation event 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, 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 Pioneer Hi-Bred International in its petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to our previous notice announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.


June 8, 2010.


You may read the documents referenced in this notice and the comments we received 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. Those documents are also available on the Internet at (​brs/​not_​reg.html) and are posted with the previous notices and the comments we received on the Web site at (​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2007-0156).

Other Information: Additional information about APHIS and its programs is available on the Internet at (

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Ms. Karen Green, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0672, email: ( To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, email: (

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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 Start Printed Page 32357determination 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.

In a notice 1 published in the Federal Register on September 2, 2009 (74 FR 45413-45415, Docket No. APHIS-2007-0156), APHIS announced the availability of Pioneer’s petition and the associated draft environmental assessment (EA) and plant pest risk assessment for public comment. APHIS solicited comments for 60 days ending on November 2, 2009, on whether the genetically engineered soybean is or could be a plant pest and on the draft EA and the risk assessment. In a subsequent notice published in the Federal Register on October 26, 2009 (74 FR 54950-54951, Docket No. APHIS-2007-0156), we extended the comment period until December 28, 2009.

APHIS received 40 comments during the comment period. There were 22 comments from groups or individuals who supported deregulation and 18 from those who opposed deregulation. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact.

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 Pioneer’s 305423 soybean, an EA has been 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, the response to public comments, and other pertinent scientific data, APHIS has reached a finding of no significant impact with regard to the preferred alternative identified in the EA, i.e., that Pioneer’s 305423 soybean line and lines developed from it are granted nonregulated status and are no longer regulated articles under its regulations in 7 CFR part 340.


Based on APHIS’ analysis of field, greenhouse, and laboratory data submitted by Pioneer, references provided in the petition, information analyzed in the EA, the plant pest risk assessment, comments provided by the public, and information provided in APHIS’ response to those public comments, APHIS has determined that Pioneer’s 305423 soybean is unlikely to pose a plant pest risk and should be granted nonregulated status.

Copies of the signed determination document, as well as copies of the petition, plant pest risk assessment, EA, finding of no significant impact, and response to comments are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

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Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

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Done in Washington, DC, this 2nd day of June 2010.

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Kevin Shea

Acting Administrator, Animal and Plant Health Inspection Service.

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1.  To view the notices, petition, EA, risk assessment, and the comments we received, go to (​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2007-0156).

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[FR Doc. 2010-13722 Filed 6-7-10; 6:37 am]