January 5, 2000Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
RE: Comments on FDA Docket 99N-4282 (Policy on Food Biotechnology)Henry I. Miller, MD
Stanford, CA 94305-6010
I am a former FDA reviewer, manager and office director. From 1979-93, I had responsibility for various aspects of biotechnology product review and/or policy-making; I was the founding director of the agency's Office of Biotechnology, 1989-93. As a fellow at Stanford University's Hoover Institution since 1994, I have studied domestic and international regulation of biotechnology. I have published widely on various aspects of biotechnology, including three books and more than 300 articles.
The attached two reprints summarize my views on the FDA's oversight of foods and food ingredients made with the techniques of the new biotechnology. In short, the agency's 1992 policy on foods from new plant varieties is scientifically defensible and risk-based (with the exception of CFSAN's "voluntary consultation procedures," which are, in fact, hardly voluntary and are, arguably, extra-legal). The agency's official policy generally conforms to the broad scientific consensus that gene-splicing is an extension, or refinement, of earlier, widely-used techniques.
Therefore, the underlying principles and scientific assumptions embodied in this policy should continue to serve as the basis for the FDA's approach to biotech foods. Altering this policy in any way that discriminates against or excessively regulates the use of gene-splicing - that is, to focus regulation on the use of certain processes or techniques, instead of on the characteristics or use of a product - would jeopardize the ability of research and development to offer important new products to American consumers.
** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. **
Last Updated on 1/7/00
By Karen Lutz