October 28-30, 2025 POSTPONED
The workshop originally scheduled for October 28-30, 2025 has been postponed due to the ongoing U.S. government shutdown. The participation of federal regulatory presenters from USDA-APHIS, FDA, and EPA is essential for delivering a successful workshop.
Stay Tuned for New Dates
Case Studies
- Canker-resistant Citrus
- Insect Resistant and Herbicide Tolerant DP23211 Maize
- Gene-edited S4A Strawberry
2025 Workshop Agenda
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 – U.S. Regulatory Agencies & Role within the Coordinated Framework
- USDA-APHIS – Donna Lalli
- FDA – Jason Dietz
- EPA – Shannon Borges
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 – Rebecca Fletcher
3:05 pm – EPA response – Amanda Pierce
3:25 pm – FDA response – Charles Kanobe
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: Insect Resistant and Herbicide Tolerant DP23211 Maize
Moderator: Chris Dardick
11:00 am – Case Study #2 Overview – Insect Resistant and Herbicide Tolerant DP23211 Maize – Jamie Staley, Corteva
11:30 am – EPA response – Alex Blumenfeld
11:50 am – FDA response – Jing Ning
12:10 pm – APHIS response – Abigail Walter
12:30 pm – Q&A Discussion
1:15 pm – Lunch Break
Session 4: Beyond the Trait: Field trials and Marketing Strategies
Moderator: Wayne Parrot
1:45 pm – The 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 – Sarah Evanega, Okanagan Specialty Fruits
2:45 pm – Q&A Discussion
Session 5: Review & Discussion of Case Study #3: Gene-edited S4A Strawberry
Moderator: Wayne Parrot
3:15 pm – Case Study #3 Overview: Gene-edited S4A Strawberry – Muffy Koch, J.R. Simplot
3:45 pm – FDA response – Matt Fabian
4:05 pm – APHIS response – Kenneth Haymes
4:25 pm – EPA response – Amanda Pierce
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: An International Regulatory Perspective
Moderator: Kellye Eversole
10:00 am – An Overview of Canada’s Regulatory Frameworks for Genetically Engineered and Gene-Edited Crops – Jordan Bean, Health Canada
11:00 am – Q&A Discussion
Session 7: Dissecting the U.S. Regulatory System
Moderator: Jennifer Rowland
12:00 pm – Ask the Regulator: Common Mistakes and Pitfalls about Developing a Regulatory Plan for the U.S. Regulatory System.
Panel participants: Jason Dietz and Jianmei (Jamie) Zhu, FDA; Subray Hegde, APHIS; Mike Mendelsohn, EPA
1:45 pm – Workshop Wrap up & Announcements – Dusti Gallagher and Wayne Parrott
2:00 pm – Adjournment