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2018 SCRA Workshop

The next SCRA workshop will be held in Riverdale, Maryland on October 3-5 2018.

Registration is now open! Click here to register.

This will be the third installment of our workshops held in 2011 and 2016.

To be commercialized and grown in the US, genetically engineered (GE) crops go through an extensive food, feed, and environmental safety assessment process, which in certain instances, requires complex consultations with three different US regulatory agencies. Many small market, niche, and specialty crops have been genetically engineered over the past 25 years but the majority has not been commercialized due to real or perceived regulatory constraints.

This workshop is partially supported by the Biotechnology Risk Assessment Grants (BRAG) program on the practical aspects of developing dossiers on genetically engineered (GE) specialty, niche, or small-market crops/products for submission to US regulatory agencies. While most workshops on the US regulatory system for biotech-derived crops provide general overviews of various aspects of the regulatory process, this workshop presents an opportunity for public sector scientists and public or private crop developers to spend two days with regulatory officials and learn the specifics of putting together an actual dossier for regulatory approval.

Workshop participants have the opportunity to spend two days with regulatory officials from the 3 agencies with jurisdiction over GE products (USDA-APHIS, FDA, and EPA) and learn the specifics of putting together dossiers for regulatory approval. Overviews of the regulatory requirements of APHIS, EPA, and FDA will be presented by representatives from each agency. The majority of the workshop, however, focuses on actual case studies (i.e., dossiers of actual approved GE products and of GE products poised to enter or complete the regulatory process). After a brief overview by the product/crop developer, the case study is used by the participating officials of each relevant agency to explain how assessments were or would be conducted. To ensure the broadest exchange of information among participants, workshop discussions are off-the-record.

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