Global Regulatory Status of Gene Edited Products
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Global Regulatory Status of Gene Edited Products by S. Ruthner during the Regional Expert Consultation on Gene Editing in Agriculture and its Regulations Technical Session I
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Global Regulatory Status of Gene Edited Products
- 1. Global Regulatory Status of Gene Edited Products Regional Expert Consultation on Gene Editing in Agriculture and its Regulation 10-11 October, 2019 Hyderabad, India
- 2. 2 • “Voice of the global seed industry” • Non-governmental, non-profit making organization • Recognizes its members’ contributions to food security and sustainable agriculture. What is ISF?
- 3. ISF in figures 3 58 National Seed Associations 75 countries 7500+ companies
- 4. PLANT BREEDERS’ RESPONSE TO GLOBAL CHALLENGES
- 5. The Plant Breeding Innovation Tradition
- 7. 7 Plant Breeding Innovation: Goals of Global Seed Sector The seed sector and agriculture are global—what are our goals? ─ Clear, science-based, government policy ─ Facilitation of innovation and collaboration ─ Consistent policies across economies
- 8. Basic Approach • Goal: Consistent, science-based approach for regulatory oversight • Agreement among governments on the criteria to determine the scope of regulatory oversight Underlying principle: “Plant varieties developed through the latest breeding methods should not be differentially regulated if they are similar or indistinguishable from varieties that could have been produced through earlier breeding methods.” 8
- 9. What we need…. Two essential factors affect predictability of policy approach 1. Agreement on criteria to determine scope of regulatory oversight 2. Agreement around implementation--timelines and any requirements Recognition of the existing regulatory mechanisms for new plant varieties and resulting products • variety registration • seed laws and regulations • phytosanitary regulations • general environmental safety/liability laws and regulations • general food/feed laws and regulations 9
- 10. 10 Argentina, Chile, Brazil, Paraguay Colombia, Honduras, Guatemala: Case-by-case approach, excluding certain edited products (El Salvador likely to follow) NZ: High Court decision that a few specific techniques are GMO US: Proposed new USDA policy excludes certain techniques; Executive Order on Modernizing Regulatory Framework for Biotechnology Canada: Product based approach; ongoing discussions to improve system Europe: ECJ decision calls all mutagenesis “GMO” and subject to EU GMO regulation China: China unofficial “GMO-lite” proposal Australia: Revised gene tech regulation exclude some gene editing applications Israel: Guidance that specific techniques are outside GMO scope Policy developments in different Countries around the world (10/2019) Russia: decree for R&D program clarifying that “conventional-like” genome editing products are not regulated as “GMO” Japan: excluding certain edited products (Korea likely to follow)
- 11. Comparison of existing regulations in South America Last Updated 1 Oct, 2019 Agency No DNA sequence from a different species DNA sequence from a different species Countries Targeted deletions Targeted edits Targeted allele replacements Targeted insertions Null Segregant Targeted Insertion Argentina MAGYP No No No Yes No Yes Chile SAG No No No Yes No Yes Brazil CTNBio No No No Yes No Yes Colombia ICA No No No Yes No Yes Paraguay CONBIO No No No Yes No Yes Honduras SENASA No No No Yes No Yes Guatemala MAGA No No No Yes No Yes
- 12. QUANTITATIVE IMPACT ON INNOVATION (ARGENTINA) 0 2 4 6 8 10 12 14 2008 2010 2012 2014 2016 2018 Approved GM crops Precision breeding products Source: Whelan, Lema (2019).
- 13. IMPACT ON INNOVATORS´ PROFILE DIVERSIFICATON (ARGENTINA) GM crops approved Foreign SMEs Multinational Companies National SMEs and Research institutions Precision Breeding Products Foreign SMEs Multinational Companies National SMEs and Research institutions Source: Whelan, Lema (2019).
- 14. MORE DIVERSITY IN IMPROVED SPECIES, MORE INNOVATION (ARGENTINA) Cereals Oilseeds Fiber crops Fruits and Vegetables Ornamental Livestock Fish Microorganisms PRECISION BREEDING PRODUCTS Cereals Oilseeds Fiber crops Fruits and Vegetables APPROVED GMO (ONLY CROPS)
- 15. Impact of Public Policy-Lessons from the Past The risk is to create another system of patchwork regulations and asynchronous decisions repeating some of the mistakes of GMO regulation 1. Only the largest seed companies will have the financial capability to manage the costs related to regulation. 2. Only a limited number of crops will benefit from breeding innovations. 3. The accessibility of these tools to the academic community, domestic agricultural research organizations, and international agricultural research centers / CGIAR centers will be restricted. 4. Global economic activity in the seed and grain trade will decrease. 5. Research cooperation and germplasm exchange for global breeding will become more challenging. 6. Increasing productivity in a sustainable way will become more challenging. 15
- 16. Conclusion 16 Latest breeding methods provide opportunities to target global challenges as well as local needs and can help us achieve sustainable agricultural production and food security.
- 17. Chemin du Reposoir 7 | 1260 Nyon | Switzerland www.worldseed.org Seed is Life
Notes de l'éditeur
- This set of slides tells the plant breeding innovation story. Slides 3-5 set the scene with the global challenges and explains the role of plant breeding innovation in overcoming them, supported by statistics. Slides 6-7 explore the goals of plant breeding innovation and current definitions. Slides 8-10 demonstrate the evolution of plant breeding methods and describe gene editing techniques. Slides 11-14 examine the regulatory aspects in the context of the ISF Consistent Criteria paper
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