Small Market Biotech Crops Initiative

Navigating the regulatory process and obtaining approval from as many as three federal agencies is a significant challenge in commercializing a new biotechnology-derived crop. This can be especially daunting for entities working on specialty crops or developing products with limited markets. On January 2005, the Secretary of Agriculture awarded $35,000 for drafting and obtaining stakeholder input on a proposed organizational plan for a Specialty Crops Regulatory Initiative (SCRI) to assisting developers of such crops through the scientific regulatory approval process. The proposed initiative will help clarify regulatory data requirements, collect required data, maintain a database of information for future applications, and serve as a liaison with regulatory agencies.

The SCRI grew out of recommendations of a workshop, “Public Research and the Regulatory Review of Small-Market (Specialty) Biotechnology-Derived Crops,” held November 8-9, 2004, to discuss how the public research sector, regulatory agencies and the private sector could collaborate to facilitate the regulatory review of specialty (small market) biotechnology-derived crops. Over 125 federal, academic and private-sector leaders participated.

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