April 2005 E-News

Specialty Crops Regulatory Initiative receives support from U.S. Secretary of Agriculture.
A workshop on regulatory issues for specialty crops held in November 2004 in Washington, D.C. resulted in a recommendation for the establishment of a program to assist public researchers and small companies with meeting the regulatory requirements for commercializing crops developed using biotechnology. Modeled in part on the successful IR-4 program that assists in extending registrations for agricultural chemicals to smaller market crops, the Specialty Crops Regulatory Initiative (SCRI) would help in clarifying and standardizing data requirements, serve as a liaison with APHIS, FDA, EPA and other governmental organizations, identify crop/trait combinations of high value and priority for commercialization, assist in collecting the required data, such as compositional analyses or feeding studies, and maintain a database of information that could be utilized for subsequent petitions. It could also support research that would provide data relevant to changes in the regulatory procedures or requirements. A feasibility committee chaired by Dr. Alan McHughen at UC Riverside recently received $35,000 from the U.S. Secretary of Agriculture’s office to seek stakeholder input and further refine the parameters of the program. Kent Bradford, Director of the SBC, is a member of this committee and will continue to work on implementation of this initiative.

Pew Initiative on Food and Biotechnology releases report. 
The Pew Initiative on Food and Biotechnology has released a report, Impacts of Biotech Regulation on Small Business and University Research: Possible Barriers and Potential Solutions, based on a workshop in June, 2004. David Tricoli of the Ralph M. Parsons Foundation Plant Transformation Center at UC Davis participated in this workshop and contributed substantially to its conclusions, which support the need for the SCRI. The full report is available at http://www.pewtrusts.org/our_work.aspx?category=442

Analysis of current biotechnology regulatory system published.
Kent Bradford and Allen Van Deynze (SBC), Neal Gutterson (Mendel Biotech), Wayne Parrott (University of Georgia) and Steve Strauss (Oregon State University) have published an article in Nature Biotechnology (2005, 23: 439-444) titled “Regulating transgenic crops sensibly: lessons from plant breeding, biotechnology and genomics.” The abstract states: “The costs of meeting regulatory requirements and market restrictions guided by regulatory criteria are substantial impediments to the commercialization of transgenic crops. Although a cautious approach may have been prudent initially, we argue that some regulatory requirements can now be modified to reduce costs and uncertainty without compromising safety. Long-accepted plant breeding methods for incorporating new diversity into crop varieties, experience from two decades of research on and commercialization of transgenic crops, and expanding knowledge of plant genome structure and dynamics all indicate that if a gene or trait is safe, the genetic engineering process itself presents little potential for unexpected consequences that would not be identified or eliminated in the variety development process before commercialization. We propose that as in conventional breeding, regulatory emphasis should be on phenotypic rather than genomic characteristics once a gene or trait has been shown to be safe.” The full article can be obtained at http://www.nature.com/nbt/journal/v23/n4/full/nbt1084.html or from the SBC website at http://sbc.ucdavis.edu .

For questions or comments please contact:

Susan C. Webster
Program Representative
Seed Biotechnology Center
University of California
Plant Reproductive Biology
Extension Center Drive
Davis CA 95616
phone: 530.754.7333
fax: 530.754.7222

scwebster@ucdavis.edu
http://sbc.ucdavis.edu