The 2023 Nuts and Bolts workshop took place virtually on September 19-21, 2023
Case Studies
- Purple Tomato
- MON 87411-SmartStax ProTM
2023 Workshop Agenda
Tuesday, September 19 | 11:00 a.m. – 5:15 p.m. EDT
11:00 a.m. – Welcome and Introductions – Kellye Eversole, Eversole Associates – Slides (PDF)
Session 1: Navigating the U.S. Regulatory System
Moderator: Kellye Eversole
11:10 a.m. – Overview of the Coordinated Framework – Dusti Gallagher, Eversole Associates – Slides (PDF)
11:25 a.m. – Role of U.S. Regulatory Agencies within the Framework
- USDA-APHIS – Suma Chakravarthy – Slides (PDF)
- FDA – Jason Dietz – Slides (PDF)
- EPA – Alan Reynolds – Slides (PDF)
11:40 a.m. – Q&A Discussion
Session 2: Review & Discussion of Case Study #1: Purple Tomato
Moderator: Kellye Eversole
12:00 p.m. – Case Study 1 Overview – Purple Tomato – Nathan Pumplin, Norfolk Healthy Produce – Slides (PDF)
12:30 p.m. – EPA response – Alan Reynolds
12:50 p.m. – APHIS response – Abigail Walter – Slides (PDF)
1:10 p.m. – FDA response – Jamie Zhu – Slides (PDF)
1:30 p.m. – Q&A Discussion
2:15 p.m. – Lunch Break
Session 3: International Regulations at a Glance
Moderator: Jessica Mahalingappa and Chris Dardick, USDA
2:45 p.m. – National and regional regulatory frameworks for biosafety outside the U.S. – Piet van der Meer, Ghent University and the Free University of Brussels, Belgium – Slides (PDF)
3:15 p.m. – Global Overview of International Regulations – Chris Peterson, Trade Policy & Geographic Affairs, FAS-USDA
3:45 p.m. – Practical Trade Considerations of Okanagan Apple – Neal Carter, Okanagan Specialty Fruits, British Columbia, Canada – Slides (PDF)
4:15 p.m. – Feed the Future Insect Resistant Eggplant Partnership – Maricelis Acevedo, Cornell University – Slides (PDF)
4:30 p.m. – Q&A Discussion
5:15 p.m. – Adjourn for the Day – Dusti Gallagher
Wednesday, September 20 | 11:00 a.m. – 4:45 p.m. EDT
11:00 a.m. – Welcome and Introductions – Dusti Gallagher, Eversole Associates
Session 4: Review and Discussion of Case Study #2: MON 87411-SmartStax ProTM
Moderator: Dusti Gallagher
11:00 a.m. – Case Study 2 – MON 87411-SmartStax ProTM
Trait Overview and EPA response – Nina Ortiz – Slides (PDF)
11:50 a.m. – APHIS response – Katharine Swoboda Bhattarai – Slides (PDF)
12:10 p.m. – FDA response – Jason Dietz – Slides (PDF)
12:30 p.m. – Q&A Discussion
1:15 p.m. – Lunch Break
Session 5: Dissecting the U.S. Regulatory System
Moderator: Jason Dietz, FDA
2:00 p.m. – Ask the Regulator: Common mistakes, pitfalls, and misinformation about developing a regulatory plan for the U.S. regulatory system.
Panel participants: Carrie McMahon, FDA; Kenneth Haymes, USDA APHIS; Mike Mendelsohn, EPA
Session 6: Understanding GE Microbes & U.S. Regulations
Moderator: Kellye Eversole
3:00 p.m. – GE Microbe Technology, Nik Evitt, Switch Bioworks – Slides (PDF)
3:30 p.m. – Regulatory Reactions from:
- USDA-APHIS – Kenneth Haymes
- FDA – Jason Dietz
- EPA –
- Mike Mendelson, Office of Pesticide Programs, Biopesticides and Pollution Prevention Division (BPPD), Emerging Technologies Branch
- Noland Deaver, Office of Pollution Prevention and Toxics (OPPT), New Chemicals Division, Risk Management Branch
- Gwen McClung, Office of Pollution Prevention and Toxics (OPPT), New Chemicals Division, Risk Assessment Branch – Slides (PDF)
4:00 p.m. – Q&A Discussion
4:45 p.m. – Adjourn for the Day – Kellye Eversole
Thursday, September 21 | 11:00 a.m. – 1:15 p.m. EDT
Session 7: Technology Advancements and the U.S. Regulatory System
Moderator: Kellye Eversole
11:00 a.m. – Bioengineered Products Labeling Requirements, Alexandria Fischer, MRP/AMS – Slides (PDF)
11:30 a.m. – A Glimpse into EPA’s Exemption Process for PIPs, Wiebke Striegel, EPA – Slides (PDF)
12:00 a.m. – A Glimpe into the SECURE Act Exemptions, Deshui Zhang, USDA-APHIS – Slides (PDF)
12:30 p.m. – Q&A discussion
1:00 p.m. – Workshop wrap-up, Kellye Eversole & Dusti Gallagher – Slides (PDF)
1:15 p.m. – Adjournment
Register to the mailing list to receive updates about the 2023 workshop.
Download the Workshop Agenda in PDF format
Funding for the workshop was provided through Award no. 2022-33522-37746 Biotechnology Risk Assessment Research Grants Program (BRAG)