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USDA to update biotech rules

“The science of biotechnology is continually evolving, so we must ensure that our regulatory framework remains robust by anticipating and keeping pace with those changes,” Veneman said. “A comprehensive environmental impact statement is the critical first step in the process. Our regulatory system must be both rigorous and flexible and based on sound science principles and mitigation of risks.”

USDA’s Animal and Plant Health Inspection Service will prepare an environmental impact statement evaluating its biotechnology regulations and several possible regulation changes, including the development of a multi-tiered, risk-based permitting system to replace the current permit/notification system, along with enhancements to the deregulation process to provide flexibility for long term monitoring.

Any proposed changes to the regulations will be science and risk-based, she said.

USDA’s APHIS has regulated agriculture biotechnology since 1987, ensuring the safe field testing of more than 10,000 GE organisms and overseeing the deregulation of more than 60 GE products.

Over the past several years, USDA has taken steps to strengthen its biotechnology regulations through the creation of the biotechnology regulatory services program, enhancements to its permitting system for plant-made pharmaceuticals and industrials and the development of a compliance and enforcement unit to ensure adherence to the agency’s regulations.

APHIS welcomes comments and input from stakeholders and the public to assist in determining the scope of the EIS and any proposed regulations. This notice is scheduled for publication in the Jan. 23 Federal Register and is available for viewing today at

APHIS documents published in the Federal Register and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at

Consideration will be given to comments received on or before Feb. 23. Comments may be submitted by postal mail, commercial delivery or e-mail.

Send an original and three copies of postal mail or commercial delivery comments to Docket No. 03-031-2, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road, Unit 118, Riverdale, Md. 20737-1238. If you use e-mail, address comments to Comments must be contained in the body the message; do not send attached files. Please include your name and address in the body of the message and use “Docket No. 03-031-2" on the subject line.

Comments may be reviewed in USDA’s South Building, Room 1141, 14th Street and Independence Avenue, SW, Washington, D.C., between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to view comments are requested to call ahead on (202) 690-2817 to facilitate entry into the reading room.


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