The SCRA) organizes workshops on the practical aspects of developing dossiers on genetically engineered (GE) specialty crops for submission to US regulatory agencies
The workshops present an opportunity for small and large companies, academics, and other potential developers to spend time with regulatory officials from three US regulatory agencies (USDA-APHIS, FDA, and EPA) and learn the specifics of putting together an actual dossier for regulatory approval.
The workshops are designed to simplify and demystify data requirements and regulatory dossier development by small companies, academics, and other potential developers.
Typically, the majority of a workshop 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.