Agriculture Secretary Ann M. Veneman today announced USDA’s intention to update and strengthen its biotechnology regulations for the importation, interstate movement and environmental release of certain genetically engineered (GE) organisms.

“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 (APHIS) 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.

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, the Bush Administration has taken steps to strengthen USDA’s 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 www.aphis.usda.gov/. 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 http://www.aphis.usda.gov/ppd/rad/webrepor.html.

Consideration will be given to comments received on or before March 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 mailto:regulations@aphis.usda.gov. 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.

Comments from Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology: 

“APHIS should be commended for taking the first steps needed to ensure that the regulatory review process keeps pace with the application of genetic engineering technology to agriculture.  By proposing to conduct this review in a transparent manner in which all interested parties can participate, APHIS is taking an important step toward safeguarding public trust in the regulatory system and helping build confidence in the environmental safety of the products it approves.”

Comments from Dr. Val Giddings, vice president of agriculture for the Biotechnology Industry Organization (BIO):

“Today APHIS announced its intent to modify the regulations for biotech products that have been in place since 1986.  This decision is particularly timely and coincides with, and implements, recent recommendations from the National Academies of Science and the Pew Initiative to revisit existing regulations with an eye towards new products and applications in the R&D pipeline.

“USDA notes that current regulations have served agriculture and public health very well, but acknowledges that they must look at the new uses that scientists are exploring that will affect animals, insects, and plants for industrial and pharmaceutical needs.  We support USDA’s decision to place a high priority on this review and the desire that it be open and transparent with numerous opportunities for public involvement. 

“When the regulatory framework was created in 1986, biotechnology was a very young technology and not in everyone’s vocabulary.  Today, more people than ever understand that biotechnology touches many aspects of our lives, whether for family health, such as protection against hepatitis B and production of human insulin; our food, through consumption of higher-yielding crops grown with fewer pesticides; or the manufacturing of plastics and fuel from renewable resources such as corn and soybeans.  Therefore it is only appropriate that such a wide-ranging technology embrace extensive public participation to ensure that any concerns are addressed by scientists and health experts.

 “From a global consideration, the United States, as the leader in this technology, has the resources, ability and obligation to provide a roadmap to other rule-making bodies as they develop their own regulatory standards.  The U.S. model is built on three principles:  that all regulations are science-based; that they focus on properties of the transferred gene; and that the corresponding regulations are based on the level of risk to public health, informed by our experience and familiarity with the regulated article.  This solid foundation will be the basis for change as we look to the exciting possibilities that lie ahead.”

Comments from Dr. Jeffrey Barach, Vice President of Special Projects for the National Food Processors Association (NFPA):

“The initiatives announced by APHIS will help to ensure that the Agency's regulations keep pace with advances in agricultural biotechnology. A thorough pre-market review – which NFPA has urged APHIS to institute – will help to provide further assurances of the safety of new agricultural biotechnology applications.

“NFPA applauds APHIS's proposal to make the permitting procedure for field trials of new agricultural biotechnology crops a multi-tiered system, with oversight requirements based on a review of risk. The APHIS proposal also addresses the issue of an early safety assessment for new crop traits under development, with an emphasis on determining the safety of the biotech plant as well as ensuring containment of the plant species through appropriate good agricultural practices. NFPA believes these actions will strengthen USDA's evolving review process.”