Performing Department
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Non Technical Summary
The Specialty Crop Regulatory Assistance (SCRA) initiative is a collaborative program aimed at assisting public and privatesector developers of biotechnology-derived or Genetically Engineered speacialty crops in their efforts to complete the U.S.regulatory process for commercialization. A two-day virtual conference/workshop will be held to focus on practical aspects ofenhancing knowledge of the regulatory process for developing dossiers for submission to U.S. regulatory agencies.
Animal Health Component
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Research Effort Categories
Basic
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Applied
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Developmental
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Goals / Objectives
The main goal of the workshop is to enhance understanding among participants about the U.S. regulatory system to facilitate timely, efficient, and effective regulatory filings by small, GE crop developers.
Project Methods
In addition to the Project Director and Co-Project Director, the steering committee of the workshop will include Kellye Eversole (Chief Science and Technology Officer for IE-SCS and Executive Director of the SCRA), Subray Hegde (USDA-APHIS), Mike Mendelsohn (US-EPA), Jason Dietz (US-FDA), and Chris Dardick (USDA-ARS). The steering committee will work together to plan a two-day virtual conference/workshop focused on the practical aspects of the regulatory process for preparing dossiers on GE specialty crops for submission to U.S. regulatory agencies. This workshop is designed to simplify and demystify data requirements and regulatory dossier development for small companies, academics, and other potential developers.This committee will identify the Case Study topics to be presented by the appropriate person identified by the crop or trait developer. The invited speakers giving the regulatory responses will be the working U.S. regulatory officials who specialize in the subject matter presented and conduct the review of submissions seeking approvals in advance of prospective commercial release and developers of GE crops. Each of the three regulatory agencies and ARS will support us again for the SCRA workshop VI. Other workshop topics will include: case studies on multiple edit events, non-agronomic traits, GE microbes, and genome edited plants; Presentations on any new exemption rules and more on international regulations. Speakers for these sessions will be experts in their respective field and invited by members of the steering committee.