A Prototype Program for Attaining Specialty Crop Non-Regulated Status

Who are the customers of the service that will be developed through this proposed SBIR project Government laboratories (USDA ARS) as well as university laboratories and small companies will have need of this service-consultation and data collection for a fee, in order to commercialize products of biotechnology. The ability of the laboratory, whether public or private, to move the product toward commercialization depends critically on the ease and cost of deregulation if the product is to be grown in the agricultural sector. Currently, no service is available which fills this need. The alternative to this joint venture concept is each entity from the specialty crop perspective doing its own deregulation petition. Clearly this has not been conducive to success since few or no petitions for non-regulated status from the specialty crop sector have been submitted to the USDA-APHIS. Moreover, the Specialty Crop Regulatory Assistance was initiated to serve this purpose. The vision of SCRA is: Enhanced public good through biotechnology: Increased diversity of specialty crops, traits, and crop developers. The associated mission is: Facilitating regulatory clearance for biotechnology-derived specialty crops. The groundwork for the SCRA service organization has been laid, but funding and services have not been developed. One of the barriers to the development of the SCRA is that cooperative funding from diverse small company entities is not easy to orchestrate, particularly when funds are limited as in the current economic environment. However, the services that would be provided by the SCRA would increase sales and revenues, allowing the entity to have funds to move the SCRA project forward. In this "Catch 22", a new paradigm is necessary to move the project forward. This joint venture concept is being developed to assist the SCRA in achieving its goals. Our efforts on this project could help the SCRA develop a "regulatory atlas" which is a goal of the SCRA. While the atlas per se is not the target of this proposal, the process will help to develop different scenarios that could be used for the creation of a regulatory atlas. The public stands to benefit the most from this project because new products utilizing biotechnology that make foods/feeds/horticultural products with new traits will be available. This is important as there are many such products under development. Moreover, the confidence with which these products are embraced will be high because an independent organization will be responsible for data collection, analysis and interpretation. The benefit to the public is also in the realm of more affordable foods (manufactured with fewer inputs) and more nutritious foods.