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SCRA Nuts and Bolts Workshop 2011

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


December 6-8, 2011


USDA APHIS Center
4700 River Road
Riverdale, Maryland  20737

Unlike other workshops on the US regulatory system for biotech-derived crops, the SCRA workshop provided an opportunity for public sector scientists and public and private sector crop developers to spend two days with regulatory officials and learn the specifics of putting together an actual dossier for regulatory approval. More than 60 crop developers, scientists, and regulatory officials participated in the workshop.  In an effort to simplify and demystify data requirements and regulatory dossier development by small companies, academics, and larger industry entities with small market crops, regulatory officials used three case-studies of actual genetically engineered specialty crops.    

Workshop participants included: 

  • Specialty crop developers interested in achieving regulatory approvals for their biotech crops
  • Small and large private sector specialty crop developers
  • Public sector scientists and research managers
  • Regulatory consultants
  • Regulatory officials from USDA, the EPA, and the FDA.

The Workshop Agenda and, if available, the PowerPoint Presentations follow:

Tuesday, December 6:

 1:00pm     Welcome and Introductions

                           •    Alan McHughen, Chair, SCRA

                           •    Kellye Eversole, Executive Director, SCRA

 1:30pm     Session I: Navigating the US Regulatory System, Chair, Alan McHughen

 1:30pm     Overview of the Coordinated Framework: Sally McCammon, APHIS

 2:00pm     Overview of APHIS Requirements: John Turner, APHIS

 2:45pm     Overview of EPA Requirements: Chris Wozniak   and Sheryl Reilly , EPA                     

 3:30pm      Break

 3:45pm      Overview of FDA Consultations:  Bob Merker, FDA

 4:30pm      Discussion

Session II: Case Studies             

 5:00pm      Case Study I -  Plum Pox (Virus Resistant)

                      Moderator: June Blalock, ARS

                      Overview and Introduction by Ralph Scorza, USDA-ARS

5:45pm      Adjourn

Wednesday, December 7:

 9:00am     Case Study I -  Plum Pox (continued)

                    Presentations by agency representatives

                                •     John Cordts, APHIS

                                •     Chris Wozniak, EPA

                                •     Carrie McMahon, FDA

10:30am    Discussion           

11:00am    Break

11:15am    Case Study II - Peanut (Sclerotinia Blight Resistant)

                     Moderator:  Elizabeth Hood, Arkansas State University and IE-Strategic Crop
                                   Services

                      Overview and Introduction by Elizabeth Grabau, Virginia Tech

12:00pm     Presentations by agency representatives

                                •     Subray Hegde, APHIS

                                •     John Kough, EPA

                                •     Carrie McMahon, FDA

  1:00pm        Networking: Boxed Lunch

 2:30pm         Case Study II -  Peanut (continued)

                        Continuation of presentations by agency representatives followed by
                        discussions

 3:30pm         Case Study III - Potato (Potato Tuber Moth)

                         Moderator:  Jack Okamuro, ARS

                         Overview and Introduction by David Douches, Michigan State University

 4:15pm          Break         

 4:30pm          Presentations by representatives

                                •     Bill Doley, APHIS

                                •    Mike Mendelsohn, EPA

                                •    Carrie McMahon, FDA

 6:00pm          Adjourn

Thursday, December 8:

 9:00am        Case Study III -  Potato (continued)

                        Continuation of presentations by agency representatives followed by
                        discussions

10:00am       Session III:  General Open Discussions

                        Moderators:  Alan McHughen and Kellye Eversole

Carrie McMahon, FDA, List of Considerations

11:30am       Closing remarks:  Alan McHughen

12:00pm       Networking: Boxed Lunch     

 1:00pm        Adjournment of SCRA Workshop

 

Optional Afternoon Sessions:

          •     One-on-one sessions with regulatory consultants
                      (based on pre-scheduled appointments)

           •      Roundtable to Expedite Deregulation of Transgenic Citrus

Citrus is a critical crop threatened by a devastating disease and the subject of numerous and intensive efforts to develop resistant transgenics.  The purpose of this roundtable is to provide  guidance specific to citrus and the constructs currently under investigation. Chaired by Ed Stover, USDA-ARS.  

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