The 2025 Nuts and Bolts workshop will take place virtually on October 28-30, 2025
Case Studies
- Canker-resistant Citrus
- S4A Strawberry
2025 Workshop DRAFT Agenda (as of May 14, 2025) – Visit this page regularly for updates
All times are in US Eastern Time (EDT)
Tuesday, October 28 | 11:00 am – 4:30 pm EDT
11:00 am – Welcome and Introductions – Dusti Gallagher, Eversole Associates
Session 1: Navigating the U.S. Regulatory System
Moderator: Dusti Gallagher
11:15 am – State of U.S. regulatory agencies & role within the Coordinated Framework
- USDA-APHIS
- FDA – Jason Dietz
- EPA
12:45 pm – Q&A Discussion
1:45 pm – Lunch Break
Session 2: Review & Discussion of Case Study #1: Canker-resistant Citrus
Moderator: Wayne Parrot
2:15 pm – Case Study 1 Overview – Canker-resistant Citrus – Nian Wang, University of Florida
2:45 pm – APHIS response
3:05 pm – EPA response
3:25 pm – FDA response
3:45 pm – Q&A Discussion
4:30 pm – Wrap up & Adjourn Day 1
Wednesday, October 29 | 11:00 am – 5:30 pm EDT
11:00 am – Welcome and Introductions – Dusti Gallagher, Eversole Associates
Session 3: Review & Discussion of Case Study #2: TBD
Moderator: Chris Dardick
11:00 am – Case Study 2 Overview –
11:30 am – EPA response
11:50 am – FDA response
12:10 pm – APHIS response
1:15 pm – Lunch Break
Session 4: Under-represented Aspects of Biotechnology
Moderator: Wayne Parrot
1:45 pm – Nuances of Biotech Field Trials & Permitting – Chris Dardick, ARS
2:15 pm – Marketing Strategies: How to avoid over promising and under delivering new product value and benefits – Speaker Invited
2:45 pm – Q&A Discussion
Session 5: The Gene Editing Regulatory Landscape
Moderator: Wayne Parrot
3:15 pm – Case Study #3 Overview: Gene Edited S4A Strawberry – Muffy Kock, J.R. Simplot
3:45 pm – FDA response
4:05 pm – APHIS response
4:25 pm – EPA response
4:45 pm – Q&A Discussion
5:30 pm – Wrap up & Adjourn Day 2
Thursday, October 30 | 10:00 am – 2:00 pm EDT
Welcome and Introductions – Dusti Gallagher, Eversole Associates
Session 6:The European Union Regulatory Perspective
Moderator: TBD
11:00 am – A deep dive into European Union regulations – Speaker Invited
11:30 am – Q&A Discussion
Session 7:Dissecting the U.S. Regulatory System
Moderator: Jennifer Rowland
12:00 pm –Ask the Regulator: Common mistakes, pitfalls, and misinformation about developing a regulatory plan for the U.S. regulatory system.
Panel participants: Jason Dietz, FDA; Subray Hegde, USDA APHIS; Mike Mendelsohn, EPA
1:45 pm – Workshop Wrap up & Announcements – Dusti Gallagher and Wayne Parrott
2:00 pm – Adjournment