The 2021 Nuts and Bolts Workshop took place on June 8-9, 2021 (virtual event)
Case studies:
- High Oleic Soybean
- Blight Resistant Potato
2021 Workshop Agenda
Tuesday, June 8 — 10:00 a.m. – 5:30 p.m. EDT
10:00 a.m. – Welcome and introductions – Kellye Eversole, IE-SCS
Session 1: Navigating the new U.S. regulatory system
Moderator: Kellye Eversole, IE-SCS
10:15 a.m. – Overview of the Coordinated Framework, Sally McCammon – Slides (PDF)
10:45 a.m. – Overview of APHIS requirements, Subray Hegde – Slides (PDF)
11:15 a.m. – Overview of EPA requirements, Chris Wozniak – Slides (PDF)
11:45 a.m. – FDA consultations, Jason Dietz – Slides (PDF)
12:15 p.m. – Discussion
1:00 p.m. – Lunch break
Session 2: Review & Discussion of Case Study #1: High Oleic Soybean
Moderator: Elizabeth Hood, IE-SCS
1:45 p.m. – Case Study 1 Overview – High Oleic Soybean – Chloe Pavely, Global Regulatory Director, Calyxt, Inc. – Slides (PDF)
2:15 p.m. – APHIS response, Kenneth Haymes – Slides (PDF)
2:35 p.m. – EPA response, Chris Wozniak
2:55 p.m. – FDA response, Patrick Cournoyer – Slides (PDF)
3:15 p.m. – Open discussion
Session 3: Myths and Truths about the U.S. regulatory system
Moderator: Elizabeth Hood, IE-SCS
4:00 p.m. – Suma Chakravarthy, USDA – Slides (PDF)
Elizabeth Milewski, EPA – Slides (PDF)
Carrie McMahon, FDA – Slides (PDF)
4:45 p.m. – Discussion and Wrap-up
5:30 p.m. – Adjourn for the Day
Wednesday, June 9 — 1:00 – 5:00 p.m. EDT
Welcome and introductions – Alan McHughen, University of California, Riverside
Session 4: Review and Discussion of Case Study #2: Blight Resistant Potato
Moderator: Alan McHughen, University of California, Riverside
1:00 p.m. – Case Study 2 Overview – Blight Resistant Potato – Matthew Pence, Regulatory Manager, J.R. Simplot Company – Slides (PDF)
1:30 p.m. – APHIS response, Kate Rappaport – Slides (PDF)
1:50 p.m. – EPA response, Natalya Baranova – Slides (PDF)
2:10 p.m. – FDA response, Jason Dietz – Slides (PDF)
2:30 p.m. – Open discussion
Session 5: Various Case Studies: Review & Discussion of Unique Aspects of Case Studies as Identified by U.S. Regulatory Agencies
Moderator: Alan McHughen, University of California, Riverside
3:15 p.m. – APHIS – Deshui Zhang – Slides (PDF)
3:40 p.m. – FDA – Pink Pineapple – Carrie McMahon – Slides (PDF)
4:05 p.m. – EPA – Chris Wozniak – Slides (PDF)
4:15 p.m. – Open discussion and Wrap-up
5:00 p.m. – Workshop wrap-up and adjournment – Kellye Eversole, IE-SCS – Slides (PDF)