The 2018 Nuts and Bolts Workshop took place in Riverdale, Maryland, USA on 3-5 October 2018
Case studies:
- Transgenic Blight Resistant American Chestnut
- Golden Rice
- Hypoallergenic Peanut
This was the third installment of our workshops held in 2011 and 2016.
To be commercialized and grown in the US, genetically engineered (GE) crops go through an extensive food, feed, and environmental safety assessment process, which in certain instances, requires complex consultations with three different US regulatory agencies. Many small market, niche, and specialty crops have been genetically engineered over the past 25 years but the majority has not been commercialized due to real or perceived regulatory constraints.
While most workshops on the US regulatory system for biotech-derived crops provide general overviews of various aspects of the regulatory process, this workshop presents an opportunity for public sector scientists and public or private crop developers to spend two days with the regulatory officials from the 3 agencies with jurisdiction over GE products, USDA-APHIS, FDA, and EPA, and learn the specifics of putting together an actual dossier for regulatory approval.
Overviews of the regulatory requirements of APHIS, EPA, and FDA were presented by representatives from each agency. The majority of the workshop, however, focuses on actual case studies (i.e., dossiers of actual approved GE products and of GE products poised to enter or complete the regulatory process). After a brief overview by the product/crop developer, the case study is used by the participating officials of each relevant agency to explain how assessments were or would be conducted. To ensure the broadest exchange of information among participants, workshop discussions are off-the-record.
This workshop is partially supported by the Biotechnology Risk Assessment Grants (BRAG) program on the practical aspects of developing dossiers on genetically engineered (GE) specialty, niche, or small-market crops/products for submission to US regulatory agencies.
2018 Workshop Agenda
Wednesday, 3 October 10:30am – 5:00pm
Special Session: US Regulation and Plant Breeding Innovation: An Update
10:30am Introduction – Beth Hood
10:35am FDA – Patrick Cournoyer
10:50am EPA – Chris Wozniak
11:00am APHIS – Mike Firko
11:45am Questions
12:00pm Lunch
1:30pm Welcome and Introductions
2:00pm Session 1: Navigating the US Regulatory System
Overview of the Coordinated Framework (30min) – Sally McCammon
Overview of APHIS Requirements (30min) – John Turner
Overview of EPA Requirements (30min) – Alan Reynolds
3:30pm Break
3:45pm Session 1 Continued:
Overview of FDA Consultations (30min) – Patrick Cournoyer
4:15pm Discussion
5:00pm Adjourn for day
Thursday, 4 October 9:00am – 5:00pm
9:00am Case Study 1 – American Chestnut
Overview and Introduction by developer Bill Powell
9:45am Presentations by agency representatives
APHIS (30min) – Christina Vieglais
EPA (30min) – Chris Wozniak
10:45am Break
11:00am Presentations by agency representatives continued
FDA (30min) – Bob Merker
1:30am Case Study 1 Discussion
12:30pm Networking Boxed Lunch
1:30pm Case Study 2 – Golden Rice
Overview and Introduction by developer Don MacKenzie
2:15pm Presentations by agency representatives
APHIS (30min) – Deshui Zhang
EPA (30min) – Chris Wozniak
3:15pm Break
3:30pm Presentations by agency representatives continued
FDA (30min) – Carrie McMahon
4:00pm Case Study 2 Discussion
5:00pm Adjourn for the day
Friday, 5 October 9:00am – 12:15pm
9:00am Case Study 3 – Hypoallergenic Peanut
Overview and presentation by developer Hortense Dodo
9:45am Presentations by agency representatives
APHIS (30min) – Subray Hegde
EPA (15min) – Chris Wozniak
10:30am Break
10:45am Presentations by agency representatives continued
FDA (30min) – Jason Dietz
11:15am Case Study 3 and General Discussion
12:15pm Official Adjournment of workshop
1:30-3:30pm Special Satellite Session with Citrus Group