2011 Workshop

The 2011 SCRA Workshop “Nuts and Bolts of US Regulatory Dossiers for Genetically Engineered Crops” was successfully held on 6-8 December 2011 in Riverdale, Maryland.

Unlike other workshops on the US regulatory system for biotech-derived crops, the SCRA workshop provided an opportunity for public sector scientists and public and private sector crop developers to spend two days with regulatory officials and learn the specifics of putting together an actual dossier for regulatory approval. More than 60 crop developers, scientists, and regulatory officials participated in the workshop.  In an effort to simplify and demystify data requirements and regulatory dossier development by small companies, academics, and larger industry entities with small market crops, regulatory officials used three case-studies of actual genetically engineered specialty crops.

Workshop participants included:

– Specialty crop developers interested in achieving regulatory approvals for their biotech crops
– Small and large private sector specialty crop developers
– Public sector scientists and research managers
– Regulatory consultants
– Regulatory officials from USDA, the EPA, and the FDA

Agenda and presentations

Tuesday 6 December
1:00pm – Welcome and Introductions: Alan McHughen, Chair, SCRA and Kellye Eversole, Executive Director, SCRA
1:30pm – Session I: Navigating the US Regulatory System, Chair, Alan McHughen
1:30pm – Overview of the Coordinated Framework: Sally McCammon, APHIS
2:00pm – Overview of APHIS Requirements: John Turner, APHIS
2:45pm – Overview of EPA Requirements: Chris Wozniak and Sheryl Reilly, EPA
3:30pm – Break
3:45pm – Overview of FDA Consultations:  Bob Merker, FDA
4:30pm – Discussion
Session II: Case Studies
5:00pm – Case Study I –  Plum Pox (Virus Resistant)
Moderator: June Blalock, ARS
Overview and Introduction by Ralph Scorza, USDA-ARS
5:45pm – Adjourn

Wednesday 7 December
9:00am – Case Study I –  Plum Pox (continued), Presentations by agency representatives
John Cordts, APHIS
Chris Wozniak, EPA
Carrie McMahon, FDA
10:30am – Discussion
11:00am – Break
11:15am – Case Study II – Peanut (Sclerotinia Blight Resistant)
Moderator:  Elizabeth Hood, Arkansas State University and IE-Strategic Crop Services
Overview and Introduction by Elizabeth Grabau, Virginia Tech
12:00pm – Presentations by agency representatives
Subray Hegde, APHIS
John Kough, EPA
Carrie McMahon, FDA
1:00pm – Networking: Boxed Lunch
2:30pm – Case Study II – Peanut (continued) Continuation of presentations by agency representatives followed by discussions
3:30pm – Case Study III – Potato (Potato Tuber Moth)
Moderator:  Jack Okamuro, ARS
Overview and Introduction by David Douches, Michigan State University
4:15pm – Break
4:30pm – Presentations by representatives
Bill Doley, APHIS
Mike Mendelsohn, EPA
Carrie McMahon, FDA
6:00pm – Adjourn

Thursday 8 December
9:00am – Case Study III –  Potato (continued) Continuation of presentations by agency representatives followed by discussions
10:00am – Session III:  General Open Discussions
Moderators:  Alan McHughen and Kellye Eversole
Carrie McMahon, FDA, List of Considerations
11:30am – Closing remarks:  Alan McHughen
12:00pm – Networking: Boxed Lunch
1:00pm – Adjournment of SCRA Workshop

Optional Afternoon Sessions:
– One-on-one sessions with regulatory consultants (based on pre-scheduled appointments)
– Roundtable to Expedite Deregulation of Transgenic Citrus. Citrus is a critical crop threatened by a devastating disease and the subject of numerous and intensive efforts to develop resistant transgenics.  The purpose of this roundtable is to provide  guidance specific to citrus and the constructs currently under investigation. Chaired by Ed Stover, USDA-ARS.