Agenda

19 Aug. Intro to Biotechnology, US regulations
8:30 - Welcome and Introductions
9:00 - Adrian Percy will provide an introduction to modern biotechnology. Compare and contrast traditional plant breeding with modern biotechnology, and show how they complement each other in current agriculture improvement programs (definitions, technical overview, how do new genes get into plants). HIGHLIGHT gene-edited vs genetically modified (GMO): GMOs and gene-edited organisms are used in agriculture to improve crop traits, they differ in their methods, regulatory frameworks, public perception, and potential applications. 
9:30 - U.S. Government's role in agricultural biotechnology R&D and regulation. Provide insight into the U.S. regulatory system for biotechnology products: USDA, FDA and EPA. Discuss Environmental, food safety, and socioeconomic issues associated with the use of biotechnology products, permitting process, etc. 
9:30 - Chris Peterson (USDA FAS) (via zoom) “Trade in Products of Agricultural Biotechnology, and Intro to US Regulation.” Peterson will provide an overview of the importance of trade to food security, and barriers to trade based on differences between how different countries regulate. Then, provide a very general introduction to the US Coordinated Framework as an intro before turning it over to the regulatory agencies in their slots on the agenda. 
10:45  Jason Dietz, (FDA CFSAN) (via Zoom)
1:30 - Afternoon speakers to continue the discussion from the morning 
1:30 - Amanda Pierce, EPA OPP 
2:30 - Subray Hedge, BRS (via Zoom)
3:00 - closing with a brief overview of the next day

20 Aug. History of Biotech Regulations, Components of a Regulatory Dossier
Why do we have biotech regulations, international context and history – roles of different stakeholders (governments, industry), key regulatory concepts, international context (Biodiversity Convention, Cartagena Protocol, WTO), key commonalities and differences between global biosafety regulations
Speaker: Sarah Lukie, Vice President, Trade Policy and International Affairs, CropLife International
Components of a Dossier - Evaluate the characteristics of the GMO, including its biology, genetics, and behavior. Environmental Risk Assessment and food/feed safety assessment. 
Speaker: Ali Scott, Vice President Global Regulatory Affairs Seeds, BASF
Load van at 12:30 and head to SYNGENTA
1:30-4:30 Syngenta laboratory/field tour 

21 Aug.  Regulatory Approval Process in the Context of Product Commercialization
Concept of Familiarity
Acceptance of Foreign Data/data transportability
Mutual recognition schemes / global harmonization efforts
Speaker: Clara Rubinstein 
Industry approach to developing and commercializing a biotechnology trait and the global regulatory environment (high-level overview) Applicants’ perspectives on importance of regulatory and stewardship processes for product commercialization. 
Speaker: Ray Dobert 
1:30 CLAYTON FIELD  TOUR  for Transformed Cotton and Conventional cotton (Keith Edmisten)

Working Dinner at Lakeview – dinner will include a presentation on Industry’s approach to ensuring the safety and performance of its products. Industry experts will speak on product development, regulatory affairs, insect and weed resistance, and stewardship. Followed by Q and A (Bayer, BASF, Adama, etc.)
Speakers - Ray Dobert, Ali Scott, and Charlotte Sanson

22 Aug. US and International Biotechnology Regulatory Systems
Overall theme- USDA supports agricultural biotechnologies from the lab to your plate / Intro to USDA biotech components / Economics/adoption of biotech/ BE label / Trends in innovation
Speaker: Jennifer Roland, USDA Biotech Coordinator (via Zoom)
Speaker: Jory Weintraub, NC State Director for Science Communication
Science communication, public perceptions, etc. 
Afternoon: Visit Cotton Council


23 Aug. Intro to Genome Editing
8:30 am Concepts of breeding and selection, how breeding processes are implemented in pipeline and development processes, and introduction to new breeding techniques (genome editing) and product commercialization
Speaker: Rodolphe Barrangou, Todd R. Klaenhammer Distinguished Professor in Probiotics Research in the Department of Food, Bioprocessing and Nutrition Sciences at North Carolina State University
Overview of evolving regulatory landscape / Example of commercial product: Pairwise’s mustard greens
Speaker: Dan Jenkins, VP, Regulatory and Government Affairs
GM tasting:
little purple tomatoes To engineer the purple tomatoes, scientists used transcription factors from snapdragons to trigger the tomatoes to produce more anthocyanin, creating a vibrant purple color.
pink pineapple DelMonte
arctic apple 
Buffet Lunch at PSI
Greenhouse tour at the PSB - and  Introduction to transformation of plants using CRISPR technology. 
Set up the hands-on lab portion for tomato transformations with live examples - Dr. Kadong
(done by technician before hand) Explanation of the materials used, brief explanation of the steps and show of an Agro  culture ready to use.  need materials for display and an agro culture already grown for people to see  Preparing Agrobacterium tumefaciens cultures for use in tomato transformation. Sterile techniques for handling bacterial cultures and media preparation. (10 min)
(done by technician beforehand) Explanation of the material used, brief explanation of the test, and show germinated seeds ready to use. (10 minutes)
Demonstration and hands-on practice of inoculating tomato explants with Agrobacterium cultures with already prepared agro and explants. (TEAM hands-on portion) - Cut explants (germinated baby tomato plants), inoculate them with the A. tumefaciens, and put in already prepared media and put in incubator for co-cultivation. 
(done by technician before hand) Show transformed plants to TEAM (using the magic of “it’s already been done” prior to today). (30 min)
(TEAM hands-on using a kit) DNA extraction 

23 Aug. Working Dinner – GRADUATION and Awards Ceremony
Taverna Angora, 326 Hillsborough St, Raleigh

24 Aug Safe travels home!