2018 Workshop

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
Introduction – Beth Hood
10:35am       FDA – Patrick Cournoyer
10:50am       EPA – Chris Wozniak
APHIS – Mike Firko
          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