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USDA/APHIS seeks public comment on deregulation of genetically engineered soybean MON 89788
Washington, DC
February 9, 2007

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service is seeking public comment on a petition to deregulate MON 89788, a soybean genetically engineered (GE) to be resistant to the herbicide glyphosate.

The petition for deregulation, submitted by Monsanto Company, is in accordance with APHIS’ regulations concerning the introduction of GE organisms and products. APHIS has prepared a draft environmental assessment (EA) to determine whether deregulating the soybean could have a significant impact on the environment. After a thorough review of the scientific evidence, APHIS’ current preferred action is to deregulate the soybean based on the determination that it is as safe as its traditionally bred counterparts.

APHIS makes a determination of nonregulated status only when it can conclude that the organism is no more of a plant pest risk than comparable traditionally bred organisms. If APHIS grants the 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.

MON 89788 is also subject to regulation by the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA). Monsanto has submitted documents to FDA to address these regulations.

APHIS oversees the development and introduction (importation, interstate movement and environmental release) of GE organisms. APHIS regulates GE products in cooperation with FDA and the U.S. Environmental Protection Agency. Products are regulated according to their intended use, with some products regulated under more than one agency.

APHIS has been safely regulating GE organisms since 1986 and has overseen the deregulation of more than 70 GE crop lines.

Notice of this action is published in the Feb. 5 Federal Register.

APHIS is seeking comments on the petition and invites comments on the EA. Consideration will be given to comments received on or before April 6. Send an original and three copies of postal mail or commercial delivery comments to Docket No. APHIS-2006-0195, 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, select “Animal and Plant Health Inspection Service” from the agency drop-down menu; then click on “Submit.” In the Docket ID column, select APHIS-2006-0195 to submit or view public comments and to view supporting and related materials available electronically.

Comments are posted on the Regulations.gov Web site and may also be viewed 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.


RELATED FEDERAL REGISTER NOTICE

U.S. Federal Register: Monsanto Company; availability of petition and environmental assessment for determination of nonregulated status for soybean MON 89788, genetically engineered for glyphosate herbicide tolerance

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