BIO Supports Evolving Biotech Regulatory System

Dr. Val Giddings, vice president of agriculture for the Biotechnology Industry Organization (BIO) issued the following statement in response to today's announcement by the Animal Plant Health Inspection Service (APHIS) of the United States Department of Agriculture regarding proposed changes to regulations governing biotechnology products to be published in the Federal Register January 23.

WASHINGTON, DC (January 22, 2004) -- "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."

Related Information

The Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.