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Workshop 4: Enabling Regulatory Environment for Genome Editing in Agriculture in South Korea – Opportunities & Possibilities

    December 10, 2024-December 11, 2024
    9:00 am - 5:00 pm
    Hotel InterCiti
    Daejeon, South Korea

The Agriculture and Food Systems Institute (AFSI) is organizing the fourth workshop in the series on Gene Edited Plants: Context and Communication for Plant Breeding Innovation on December 10-11, 2024 in Daejeon, South Korea. “Enabling Regulatory Environment for Genome Editing in Agriculture in South Korea: Opportunities & Possibilities” aims to improve dialogue between South Korean government officials, scientists, and other stakeholders, and enable effective communication on issues related to new plant breeding technologies. Supported by a grant from CropLife International, this in-person workshop will bring together government officials and a diverse set of stakeholders involved in biosafety approvals, including scientists and experts from the private sector, academia, Korea Biosafety Clearinghouse, public sector institutions, law firms, and other scientific organizations involved in policy discussions in the country, with the hope of fostering a science-based and transparent exchange of ideas about the regulation of genome edited agricultural products in South Korea.

Program

Overview

Spanning two days, this workshop is divided into four technical sessions:

Session 1: Genome Editing in the Context of Agriculture, Food Security, and Innovation

This session will highlight the products of genome editing at different stages of development and commercialization, around the world and particularly, in South Korea. The science behind the creation of these products will be presented to enable a better understanding of this suite of technologies in the context of traditional plant breeding and provide background for subsequent discussions during this workshop.

Session 2: Global Regulatory Landscape for Genome Edited Plants

This session will cover varying approaches that countries worldwide have taken in relation to the handling and regulation of genome edited organisms. The talks in this session will focus on the drivers for expedited pathways to review and approve genome edited products.

Session 3: Socioeconomic Considerations in Adopting Innovative Technologies

This session will encourage participants to consider the factors that matter when adopting new plant breeding techniques (or not) and the benefits they could offer, both in terms of addressing challenges in agriculture in the wake of climate change and the broad range of traits offered to end users.

Session 4: Considerations for Intellectual Property Rights for Plant Varieties

This session will focus on licensing rights and intellectual property (IP) issues associated with genome editing technologies, particularly CRISPR-Cas, in the context of commercialization by product developers. Although the IP landscape around genome editing is complex, both big and small agricultural biotechnology companies are nevertheless continuing to develop products. In this context, a favorable regulatory environment can help enable the commercialization of these products.

Background

Supported by the United States Department of Agriculture Foreign Agriculture Service (USDA FAS) New Technologies and Production Methods Division, AFSI organized three preceding technical events under this series:

  • Workshop 1, held virtually on April 22, 2021, introduced gene editing and featured presentations on the science, regulatory landscape, and communication.
  • Workshop 2, held virtually from July 19-23, 2021, allowed discussions among South Korean stakeholders to continue over the course of one week and focused on improving their understanding of the technology and varying approaches to regulating the products of gene editing.
  • Workshop 3, held in person on July 25-26, 2022 at the Plaza Hotel in Seoul, covered key concepts in problem formulation, Codex  principles, the basics of food and feed safety assessment for whole foods, and the application of safety assessment concepts to products of gene editing.

Agenda - Day 1

Tuesday, December 10, 2024 | 9:00 am – 5:00 pm

Time Title/Activity Presenter/Lead
Session 1: Genome Editing in the Context of Agriculture, Food Security, and Innovation
10:00 am Introduction to the Program and Review of the Agenda Dr. Bhavneet Bajaj
Senior Manager, Agriculture & Food Systems Institute (AFSI), USA
10:20 am Virtual Greeting Congressman Soo Jin Choi
South Korea
10:30 am Opening Remarks  Dr. Jang Ryol Liu
President, Future Food Resources Forum and Member, Korean Academy of Science and Technology, South Korea
10:45 am Global Status of Genome Edited Organisms: Better Traits and Broader Application in Enhancing Productivity and Ensuring Food Security Dr. Andrew Roberts
Chief Executive Officer, Agriculture & Food Systems Institute (AFSI), USA
11:05 am Research & Development in Agricultural Biotechnology and New Plant Breeding Techniques in South Korea: An Overview Dr. Jae-Yean Kim
Professor, Gyeongsang National University and Founder, Nulla Bio, South Korea
11:25 am Tea Break
12:00 pm Traditional Plant Breeding and Precision Breeding: History and Outlook on Similarities and Differences Dr. Wayne Parrott
Distinguished Research Professor, Institute of Plant Breeding, Genetics & Genomics, University of Georgia, USA
12:20 pm Moderated Q&A Dr. Bhavneet Bajaj
12:45 pm Lunch  
Session 2: Global Regulatory Landscape for Genome Edited Plants
1:45 pm The U.S. Food and Drug Administration’s Approach to Genome Edited Products Mr. Jason Dietz (virtual)
Senior Policy Advisor, Food and Drug Administration (FDA), USA
2:05 pm Overview of the Genome Editing Regulations in Argentina Mr. Andrés Frankow
Coordination of Innovation and Biotechnology, Secretariat of Agriculture, Livestock, and Fisheries, Argentina
2:25 pm Genome Editing Regulations in Brazil: The Case of Gene Edited Sugarcane Dr. Hugo Molinari
R&D Innovation Director, SEMPRE AgTech, Brazil
3:00 pm Tea Break  
3:20 pm Genome Editing Regulations in Singapore Ms. Emily Teo (virtual)
Senior Scientist, National Centre for Food Science, Singapore Food Agency, Singapore
3:40 pm Genome Editing Regulations in the Philippines Dr. Claro Mingala
Scientist IV, Philippine Carabao Center, Department of Agriculture, Philippines
  Ms. Alexis Marie Sagisi
Bureau of Plant Industry
Department of Agriculture
Philippines
4:10 pm Status of Regulations on Genome Editing in the European Union Mr. Jens Kahrmann
Genetic Engineering Department, Federal Office of Consumer Protection, Germany
4:30 pm Developments in Regulations on Genome Edited Plants in South Korea Mr. Junesung Jo
Senior Director and Legal Counsel, Legal Affairs, ToolGen, Inc., South Korea
4:50 pm Moderated Q&A Dr. Andrew Roberts
5:00 pm Close of Day 1  

Agenda - Day 2

Wednesday, December 11, 2024 | 9:00 am – 4:45 pm

Time Title/Activity Presenter/Lead
Session 3: Socioeconomic Considerations in Adopting Innovative Technologies
10:00 am Recap of Day 1 and Review of Agenda for Day 2 Dr. Bhavneet Bajaj
10:05 am Socio-Economic Considerations and Potential Implications for Gene-Edited Crops Dr. Stuart Smyth
Professor and Agri-Food Innovation & Sustainability Enhancement Chair, University of Saskatchewan, Canada
10:25 am Consumer Acceptance of Gene-Edited Products Dr. R. Karina Gallardo (virtual)
Professor and Extension Specialist, School of Economic Sciences, Puyallup Research and Extension Center, Washington State University, USA
10:45 am Moderated Q&A Dr. Bhavneet Bajaj
11:00 am Tea Break
11:15 am Introduction to Case Studies Dr. Bhavneet Bajaj
Case Study Discussion

  • Genome Edited Chinese Cabbage
  • Genome Edited Soybeans
Moderated Breakout Groups
1:15 pm Lunch
Session 4: Considerations for Intellectual Property Rights for Plant Varieties
2:15 pm Basics of Patenting: Why Do Scientists Patent Their Inventions? Mr. Jason Kim
Lee & Ko, South Korea
2:35 pm Intellectual Property (IP) and Legal Landscape in South Korea and the Commercial Impact on Genome Editing Mr. John Kim
Lee & Ko, South Korea
2:55 pm Moderated Q&A Dr. Andrew Roberts
3:10 pm Tea Break  
3:30 pm Case Study Presentation: GABA Tomatoes in Japan Dr. Minako Sumiyoshi
Sanatech Seed Co., Ltd., Japan
3:50 pm Case Study Presentation: Genome Edited Rice in India Dr. Satendra Kumar Mangrauthia
Senior Scientist, Institute of Rice Research, Indian Council of Agricultural Research (ICAR), India
4:10 pm Moderated Q&A Dr. Bhavneet Bajaj
4:30 pm Participant Survey Dr. Bhavneet Bajaj
4:45 pm Close of Workshop