Jim Barrett (301) 734-6405
Suzanne Bond (301) 734-5175
OF GENETICALLY ENGINEERED SOYBEAN
WASHINGTON, Sept. 2, 2009--The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is seeking public comment on a petition to deregulate a soybean genetically engineered (GE) to have higher levels of oleic acid, a monounsaturated omega-9 fatty acid. APHIS has regulated the soybean, designated as event 305423, through its permitting process since 2002.
The petition for deregulation, submitted by Pioneer Hi-Bred International, Inc., is in accordance with APHIS' regulations concerning the introduction of GE organisms and products. As part of the decisionmaking process, APHIS has also prepared a draft environmental assessment (EA) for review and comment.
Following the comment period, APHIS makes a determination of nonregulated status if it can conclude that the organism does not pose a plant pest risk. If APHIS grants the Pioneer Hi-Bred International, Inc., petition for deregulation, the soybean and its progeny would no longer be regulated articles. The product could then be freely moved and planted without the requirement of permits or other regulatory oversight by APHIS.
APHIS is responsible for protecting U.S. agriculture and the environment from animal and plant pests and has overseen the deregulation of 75 GE products. APHIS regulates GE products in cooperation with the Environmental Protection Agency (EPA) and the U.S. Department of Health and Human Services' Food and Drug Administration (FDA). In addition to APHIS review, Pioneer Hi-Bred International, Inc. has submitted the appropriate documents to FDA to address the requirements specific to that agency; FDA concluded their review and had no further questions regarding the safety of the GE soybean. FDA provides a consultation process to ensure that any human and animal feed safety issues are resolved prior to commercial distribution of a GE food. The scientific evidence indicates that there are unlikely to be any environmental, human health or food safety concerns associated with the GE soybean.
This action is published in today's Sept. 1 Federal Register. APHIS is seeking comment on the petition and on the EA.
Consideration will be given to comments received on or before Nov. 2. Send two copies of postal mail or commercial delivery comments to Docket No. APHIS-2007-0156, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. If you wish to submit a comment using the Internet, go to the
Federal eRulemaking portal at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0156.
Comments are posted on the Regulations.gov Web site and may also be reviewed at USDA, Room 1141, South Building, 14th St. and Independence Ave., S.W., Washington, D.C., between 8 a.m. and 4:30 p.m., Monday through Friday, excluding holidays. To facilitate entry into the comment reading room, please call (202) 690-2817.
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