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USDA Deregulates Genetically Engineered High Oleic Soybeans

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WASHINGTON, June 9, 2010 - The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) will deregulate a genetically engineered soybean line developed by Pioneer Hi-Bred International because it has been found to be as safe as its traditionally bred counterparts. The deregulated soybean line has been genetically engineered to have higher levels of oleic acid, and lower levels of linoleic and linolenic acids in its soybean oil.

In making an informed determination on this petition for nonregulated status, APHIS used the best available scientific information, data and expert advice available, including comments received from the public on the notice announcing the availability of the petition and the associated environmental assessment (EA) and plant pest risk assessment. APHIS also evaluated data submitted by Pioneer Hi-Bred International in its petition for a determination of nonregulated status. After analyzing this information, and carefully considering the possible environmental impacts of this action in the EA and based on the reviews conducted, APHIS concluded that the soybean line does not pose a plant pest risk.

Notice of this action is published in today's June 8 Federal Register and becomes effective upon publication.

On Dec. 20, 2006, APHIS received a petition seeking a determination of nonregulated status from Pioneer Hi-Bred International, Inc., of Johnston, Iowa, for a soybean, which genetically engineered for higher levels of oleic acid, a monounsaturated fatty acid in soybean oil. Pioneer-Hi-Bred stated that the soybean line did not present a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

APHIS announced in the Federal Register on Sept. 2, 2009 the availability of Pioneer's petition for non-regulated status, as well as the Agency's draft environmental assessment (EA) and plant pest risk assessment. APHIS is required to do both of these assessments under the National Environmental Policy Act (NEPA).

APHIS solicited comments for 60 days ending on Nov. 2, 2009, on whether the genetically engineered soybean is or could be a plant pest. In a subsequent Federal Register notice, APHIS extended the comment period until Dec. 28, 2009. APHIS received 40 comments during the comment period.

APHIS has safely regulated GE organisms since 1986 and has overseen the deregulation of more than 79 GE products.

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