The Specialty Crops Regulatory Assistance (SCRA) is a collaborative, public-private effort to assist public and private-sector developers of biotechnology-derived specialty crops in their efforts to complete the complex US regulatory process for commercialization of biotechnology-derived crops. The innovative nature of some of this research, the limited market potential, and, often, the small-scale of the developing entities make the regulatory process especially challenging. Regulatory costs and complexities can impede and obstruct the availability of diverse crops and biotechnology-derived traits even for those companies with resources to address the regulatory process.
Specialty crop growers can continue to provide an ever expanding, abundant, and diverse supply of safe, high quality food for the public good if they have ready access to diverse crops and diverse traits. The SCRA will help to ensure that regulatory costs or complexity does not stand in the way of the development of biotechnology-derived specialty crops for a range of crop developers, from small entities to large firms with interests in the specialty crops. The SCRA program will allow these entities to broaden their portfolio in the specialty crops.
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Announcing the Specialty Crop Regulatory Assistance Workshop II: Nuts and Bolts of US Regulatory Dossiers forGenetically Engineered Products
The SCRA steering committee is planning a workshop September 19-21in Riverdale, Maryland on the practical aspects of developing dossiers on genetically engineered specialty crops for submission to US regulatory agencies. This workshop is a follow-up to the highly successful workshop (Specialty Crop Regulatory Assistance Workshop: Nuts and Bolts of US Regulatory Dossiers for Genetically Engineered Crops) that was held in December 2011 with the full cooperation and participation of the three US regulatory agencies with jurisdiction over agricultural biotechnology: USDA-APHIS, EPA, and FDA.
The workshop will begin at 1:30pm on September 19th and conclude at 12:30pm on the 21st.
To see the tentative agenda for the workshop please click here.
This workshop presents an opportunity for public sector scientists and public and private sector crop developers to spend time with regulatory officials and to learn the specifics of putting together an actual dossier for regulatory review. This workshop is designed to simplify and demystify data requirements and regulatory dossier development by small companies, academics, and other potential developers. The majority of the workshop will focus on actual case studies (i.e., dossiers of actual approved GE products and of GE products poised to enter or complete the regulatory process).
Case Studies to be presented:
· Defensin-expressing citrus tree
· Blight-resistant potato with reduced acrylamide potential
· Ultra-low gossypol cotton
Infinite Eversole-Strategic Crop Services (IE-SCS) will manage and organize the workshop on behalf of the SCRA and in conjunction with the SCRA steering committee. Kellye Eversole, Chief Science and Technology Officer for IE-SCS and Executive Director of the SCRA, serves as the Project Director. Co-Project Directors and members of the SCRA steering committee are, Elizabeth Hood, Chief Executive Officer for IE-SCS, and Alan McHughen, University of California, Riverside, Carrie McMahon, Food and Drug Administration, John Cordts, Cordts’ Consulting, LLC, Chris Wozniak, Environmental Protection Agency, Sally McCammon, USDA-APHIS, and Bob Mustell, IE-SCS.
This material is based upon work that is supported by the Biotechnology Risk Assessment Grants (BRAG) program from the U.S. Department of Agriculture, under award number 2015-33522-24108
Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the U.S. Department of Agriculture. (must include this statement in this wording)