The 2016 SCRA Workshop was successfully held on 19-21 September 2016 in Riverdale, Maryland on the practical aspects of developing dossiers on genetically engineered specialty crops for submission to US regulatory agencies.
Workshop participants had the opportunity to spend two days with regulatory officials from the 3 agencies with jurisdiction over GE products (USDA-APHIS, FDA, and EPA) and learned the specifics of putting together dossiers for regulatory approval. Overviews of the regulatory requirements of APHIS, EPA, and FDA were presented by representatives from each agency. The majority of the workshop, however, focused 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 was 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 were off-the-record.
This workshop was 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 presented 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.
Report: (2019) Report on the SCRA Nuts and Bolts Workshop II: case studies of citrus greening, Ultra-low Gossypol Cotton, and blight tolerant, low-acrylamide potato, GM Crops & Food, 10:3, 139-158, DOI: 10.1080/21645698.2019.1634989
Agenda and presentations
Monday 19 September
1:30pm – Welcome and Introductions: Beth Hood, Infinite Enzymes and Kellye Eversole, Eversole Associates
2:00pm – Session 1: Navigating the US Regulatory System, Moderator: Alan McHughen, University of California Riverside
Overview of the Coordinated Framework: Sally McCammon, Mike Mendelsohn, USDA-APHIS BRS
Overview of APHIS Requirements: John Turner, USDA-APHIS BRS
Overview of EPA Requirements: Chris Wozniak, EPA
3:45pm – Session 1, continued
Overview of FDA Consultations: Patrick Cournoyer, FDA
4:15pm – Discussion
5:00pm – Adjourn
Tuesday 20 September
9:00am – Case Study 1 – Citrus Tree Defensin Protein, Moderator: Beth Hood
Overview and Introduction by developer: Mike Irey, Southern Gardens Citrus
9:45am – Presentations by agency representatives
Margaret Jones, USDA-APHIS BRS
Milutin Djurickovic and Shannon Borges, EPA
10:45am – Break
11:00am – Presentations by agency representatives continued
Bob Merker, FDA
11:30am – Case Study 1 Discussion
12:30pm – Networking Boxed Lunch
1:30pm – Case Study 2 – Simplot W-8 Potato, Moderator: John Cordts, Cordts Consulting
Overview and Introduction by developer: Susan Collinge, J.R. Simplot
2:15pm – Presentations by agency representatives
Kate Rappaport, USDA-APHIS BRS
Milutin Djurickovic and Shannon Borges, EPA
3:15pm – Break
3:30pm – Presentations by agency representatives, continued
Bob Merker, FDA
4:00pm – Case Study 2 Discussion
5:00pm – Adjourn
Wednesday, 21 September
9:00am – Case Study 3 – Ultra-low Gossypol Cottonseed, Moderator: Alan McHughen
Overview and presentation by developer: Keerti Rathore, Texas A&M
9:45am – Presentations by agency representatives
Subray Hegde, USDA-APHIS BRS
Chris Wozniak, EPA
10:30am – Break
10:45am – Presentations by agency representatives continued
Patrick Cournoyer, FDA
11:15am – Case Study 3 and General Discussion
12:15pm – Adjournment of workshop, Alan McHughen and Kellye Eversole
Infinite Eversole-Strategic Crop Services (IE-SCS) managed and organized 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.