2023 Workshop

The 2013 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

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 MendelsonOffice of Pesticide Programs, Biopesticides and Pollution Prevention Division (BPPD), Emerging Technologies Branch
    • Noland DeaverOffice of Pollution Prevention and Toxics (OPPT), New Chemicals Division, Risk Management Branch
    • Gwen McClungOffice 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)