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Biotechnology

Public Research and the Regulatory Review of Small-Market (Specialty) Biotechnology-Derived Crops

Proceedings of a Workshop, November 2004

A workshop on Public Research and Regulatory Review of Small-Market (or Specialty) Biotechnology-Derived Crops was organized by the National Center for Food and Agricultural Policy (NCFAP); Langston University, OK; and three USDA agencies—NIFA, Agricultural Research Service (ARS), and Animal Plant Health Inspection Service (APHIS). The workshop was held November 8-9, 2004, at APHIS headquarters in Riverdale, MD.

Workshop participants discussed how public research sector, regulatory agencies, and the private sector can work together to facilitate the regulatory review of specialty (small market) biotechnology-derived crops. Specific objectives included:

  • Identify aspects of in the current regulatory process that are major sources of cost and uncertainty
  • Identify researchable issues that can help meet these requirements effectively and at minimal cost
  • Consider existing models that have enabled other small-market products, also subject to regulation, to complete the requirements necessary to come to market
  • Propose one of these models or a new model for specialty transgenic crops

Discussions topics included criteria for prioritizing crops and traits to move through the regulatory process, and areas of research that could enhance and accelerate the deregulation of small market crops.

Workshop participants recommended the development of a concept for a public organization to facilitate interactions between developers of biotech specialty crops and regulatory agencies to help provide advice and data necessary for regulatory evaluation of those crops.  A planning committee formed at the workshop to coordinate the first draft of an organizational plan and organize a second workshop to add detail to the plan through input from a broader stakeholders group. 

The planning group is Specialty Crop Regulatory Assistance initiative (SCRI).  Alan McHughen, University of California-Riverside, is chair of the planning committee.   NIFA contacts for SCRI are Ann Marie Thro and William Goldner.

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