March 31, 2004

Secretary A.G. Kawamura
California Department of Food and Agriculture
1220 N Street
Sacramento, CA 95814

Dear Secretary Kawamura:

On behalf of the Union of Concerned Scientists (UCS), we urge the California Department of Agriculture (CDFA) to deny the California Rice Commission’s recent recommendation that CDFA consider Ventria Bioscience’s application to grow pharmaceutical-producing rice in California under an emergency regulatory provision. This provision, requiring a decision in 10 days, allows CDFA to circumvent the normal public review process when faced with emergency situations. We are not aware of any emergency that would justify excluding the public from the decision-making process on this application. On the contrary, this is a precedent-setting application that raises significant new food safety, trade, and environmental issues that must be fully addressed and resolved in a public process before the company proceeds.

We understand that the company is seeking an expedited review process in order to plant its lysozyme- and lactoferrin-producing rice this spring. Requests to accelerate approvals to facilitate planting schedules are commonplace among biotechnology companies seeking regulatory approvals. Failure to get into the field as soon as possible is simply not an emergency. Moreover, Ventria Bioscience has not even secured the necessary federal approval to plant this spring.

The California Rice Commission recommendation would require the company to plant the engineered rice in southern California counties. From discussions with U.S. Department of Agriculture (USDA) officials, we understand that Ventria Bioscience does not yet have a Plant Pest Act permit to grow pharmaceutical rice in California counties south of the major rice-growing area of the state. Since the USDA permit may take up to 120 days to obtain and is required before planting can begin, the company may not be able to plant this spring even with CDFA approval.

We urge CDFA to consider the commission’s recommendations under the normal process and take full advantage of the opportunity for public review and comment. The Ventria Bioscience application is the first in the United States seeking permission to grow an engineered pharmaceutical-producing crop for the purpose of commercializing pharmaceutical proteins. The state and federal reviews of this application will set important precedents for the regulation of engineered drug-producing crops.

UCS recommends that pharmaceutical crops be considered in a scientifically rigorous, transparent, participatory process involving the public and disinterested experts. We are enclosing copies of two UCS reports (Gone to Seed: Transgenic Contaminants in the Traditional Seed Supply and Pharm and Industrial Crops: the Next Wave of Agricultural Biotechnology) which raise some of the many issues that must be considered and resolved before commercialization of pharmaceutical crops is allowed in the United States.

Sincerely,

Margaret Mellon, Ph.D., J.D. 
Director                     
Food and Environment Program


Jane Rissler, Ph.D.
Senior Scientist/Deputy Director
Food and Environment Program

Enclosures