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SCRA Workshop 2016

Report Proceedings on the SCRA Nuts and Bolts Workshop II
are now available.

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. This workshop was 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. While most workshops on the US regulatory system for biotech-derived crops provide general overviews of various aspects of the regulatory process, this workshop presented an opportunity for public sector scientists and public or private crop developers to spend two days with regulatory officials and learn the specifics of putting together an actual dossier for regulatory approval.

 

Workshop participants had the opportunity to spend two days with regulatory officials from the 3 agencies with jurisdiction over GE products (USDA-APHIS, FDA, and EPA) and learned the specifics of putting together dossiers 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, focused 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 was 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 were off-the-record.

Full workshop report proceedings can be found here:

 

Specialty Crop Regulatory Assistance Workshop II:
Nuts and Bolts of US Regulatory Dossiers for
Genetically Engineered Products

September 19 - 21, 2016

The SCRA steering committee held a workshop September 19-21, 2016 in Riverdale, Maryland on the practical aspects of developing dossiers on genetically engineered specialty crops for submission to US regulatory agencies. This workshop was a follow-up to the highly successful workshop (Specialty Crop Regulatory Assistance Workshop: Nuts and Bolts of US Regulatory Dossiers for Genetically Engineered  Crops) that was held in December 2011 with the full cooperation and participation of the three US regulatory agencies with jurisdiction over agricultural biotechnology: USDA-APHIS, EPA, and FDA.

The workshop agenda and, if available presentations, follow:

Workshop Agenda:

Monday, 19 September 1:30pm -  5:00pm

 1:30pm      Welcome and Introductions: Beth Hood, Infinite Enzymes and Kellye Eversole, Eversole Associates

 2:00pm      Session 1: Navigating the US Regulatory System, Moderator: Alan McHughen, University                           of California Riverside

                   Overview of the Coordinated Framework (30min): Sally McCammon, Mike Mendelsohn,            
                   USDA-APHIS BRS

                   Overview of APHIS Requirements (30min): John Turner, USDA-APHIS BRS 

                   Overview of EPA Requirements (30min): Chris Wozniak, EPA

 3:45pmSession 1 Continued:

                   Overview of FDA Consultations (30min): Patrick Cournoyer, FDA

 4:15pm      Discussion

 5:00pm      Adjourn

 

Tuesday, 20 September 9:00am - 5:00pm

9:00am       Case Study 1 -  Citrus Tree Defensin Protein, Moderator: Beth Hood

                   Overview and Introduction by developer: Mike Irey, Southern Gardens Citrus

9:45am        Presentations by agency representatives

                    APHIS (30min) Margaret Jones, USDA-APHIS BRS 

                    EPA (30min) Milutin Djurickovic and Shannon Borges, EPA

10:45am      Break

11:00am      Presentations by agency representatives continued

                    FDA (30min) Bob Merker, FDA

11:30am      Case Study 1 Discussion

12:30pm      Networking Boxed Lunch

 1:30pm       Case Study 2 - Simplot W-8 Potato, Moderator: John Cordts, Cordts Consulting

                    Overview and Introduction by developer: Susan Collinge, J.R. Simplot

 2:15pm       Presentations by agency representatives

                    APHIS (30min): Kate Rappaport, USDA-APHIS BRS 

                    EPA (30min): Milutin Djurickovic and Shannon Borges, EPA

 3:15pm       Break

 3:30pm       Presentations by agency representatives continued

                    FDA (30min): Bob Merker, FDA

 4:00pm       Case Study 2 Discussion

 5:00pm       Adjourn

 

Wednesday, 21 September 9:00am - 12:15pm

 9:00am       Case Study 3 - Ultra-low Gossypol Cottonseed, Moderator: Alan McHughen

                    Overview and presentation by developer: Keerti Rathore, Texas A&M

 9:45am        Presentations by agency representatives

                     APHIS (30min): Subray Hegde, USDA-APHIS BRS 

                     EPA (15min): Chris Wozniak, EPA

10:30am       Break

10:45am       Presentations by agency representatives continued

                     FDA (30min):  Patrick Cournoyer, FDA

11:15am       Case Study 3 and General Discussion

12:15pm       Adjournment of workshop, Alan McHughen and Kellye Eversole

 

Infinite Eversole-Strategic Crop Services (IE-SCS) managed and organized the workshop on behalf of the SCRA and in conjunction with the SCRA steering committee. Kellye Eversole, Chief Science and Technology Officer for IE-SCS and Executive Director of the SCRA, serves as the Project Director. Co-Project Directors and members of the SCRA steering committee are, Elizabeth Hood, Chief Executive Officer for IE-SCS, and Alan McHughen, University of California, Riverside, Carrie McMahon, Food and Drug Administration, John Cordts, Cordts’ Consulting, LLC, Chris Wozniak, Environmental Protection Agency, Sally McCammon, USDA-APHIS, and Bob Mustell, IE-SCS.

 

This material is based upon work that is supported by the Biotechnology Risk Assessment Grants (BRAG) program from the U.S. Department of Agriculture, under award number 2015-33522-24108

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the U.S. Department of Agriculture. (must include this statement in this wording)

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