Plant Breeding Innovation Update CSTA Biotech Committee Krista Thomas, Director of Plant Innovation Canada Grains Council November 28, 2017
Canada Grains Council (CGC) Member Organizations
What is Plant Breeding Innovation (PBI)? International Seed Federation: “PBI is the term we use to describe the constantly evolving ideas and practices which enhance the field of plant breeding.” • Genome Editing • CRISPR Uncertainty about how the • Zinc Finger products produced using these • TALENS techniques will be regulated, how • Cisgenesis readily the public will accept • Intragenesis • Grafting on GM Rootstock them, and what the impacts will • Reverse Breeding be on international trade. • Agroinfiltration
What are the Benefits
What are the Benefits of PBI? • Lifting farmer and ag sector income • through yield increases and agronomic traits, especially in smaller-acreage crops with limited capacity to invest in plant breeding • Meeting consumer demand for healthier, high-quality food • by reducing naturally-occurring mycotoxins, increasing vitamins and nutrients, or developing new types of nutraceuticals and functional foods • Adapting to climate change and reducing the environmental impact of farming • crops that need fewer inputs and help to conserve water and soil and maintain their quality • Fighting quarantine pests • reducing devastating crop loss and risks to food security, as well as preventing serious trade disruptions
What are the Real Benefits of PBI? • Faster • Easier • Less expensive • Investments in breeding programs can go further • Opportunities for cutting-edge innovation in crops that have not adopted GM traits • Opportunities for small or orphan crops If we don’t overregulate and if we have global regulatory alignment
Canadian Grain Heavily Dependent on Trade • Majority of major field crop production exported • Up to 90% of some crops end up in export markets • For some crops there is significant diversity in export destinations (70+ countries for wheat) • China, EU, and Japan figure prominently
Annual Average Continent-to-Continent Trade of Grains and Oilseeds 2011-2015 (1000USD) Europe Americas Asia $678,924 Africa $11,585 Oceania Source: The United Nations Conference on Trade and Development International Trade Data Center. Updated 10/25/2016 VLM.
PBI Regulations: Global Overview • Many countries are considering how PBI should be regulated • Definitions of Biosafety legislation (e.g., for regulating GMOs/LMOs) • So far, no countries have indicated they will fully exempt all products of genome editing from regulatory oversight • Early approaches are case-by-case and product-based • Acknowledge the range of different products that can be produced: • Have minimal genetic changes and could otherwise be developed using conventional breeding techniques (SDN1) • Have more significant genetic changes (SDN2) • Are transgenic plants (contain a gene sequence from non-sexually compatible species) (SDN3)
Country Snapshots Argentina, Chile and Brazil Case by case reviews • • Predictable notification process (20 to 60 day review) Manageable data requirements • Six decisions made so far (all conventional breeding) •
Country Snapshots Australia Completed a public consultation on genome editing • Will include all but simple point mutations under GMO • regulations (SDN2 and SDN3 to be included) Review of Gene Technology Act underway, may allow • flexibility to treat plants differently from animals and microorganisms
Country Snapshots European Union • Currently a lack of regulatory clarity Court ruling expected December 20 th may provide indication of • regulatory direction(final ruling May/June) Increasingly politicized, linked to GMOs and pesticides • Increasing concerns about loss of agricultural innovation • • EU Commission SAM report provides scientific basis to treat some PBI products like conventional: • http://ec.europa.eu/research/sam/pdf/topics/explanatory_no te_new_techniques_agricultural_biotechnology.pdf
Country Snapshots China, Japan, South Korea • Heavy investment in genome editing technology No published guidance or regulatory decisions at this time • • Indications that some form of upfront review will be required but products without “foreign’ DNA should not be treated like GMOs
Country Snapshots Canada and the US • US agencies have consulted public FDA comment period closed in June • USDA announced they will not proceed with proposed amendments • • Some products exempted under current USDA regulations • Canadian regulators have signaled “novelty” based approach is ready to respond to products of any new breeding method Industry dialogue initiated May 30 th workshop to examine regulatory • framework
May 30 th Workshop PRESENTED BY:
Workshop Conclusions • Regulatory efficiency, transparency and predictability are key • Canada needs a modernized system that addresses true risk • Tiered model worth exploration • Ability to adopt innovation hinges on clear, predictable and consistent regulatory environment in all significant markets • Build knowledge, comfort and awareness of plant breeding innovation and the benefits it can bring to society
CGC PBI Working Group • Formed in response to Workshop, to develop input to government about the importance of supporting innovation in agriculture, without disrupting efficient trade • 14 CGC members currently participating: • CSTA, CropLife Canada, CSGA, Cereals Canada, Canola Council, Cargill, GFO, GGC, Monsanto, Pulse Canada, Sask Flax, Soy Canada, Syngenta, Wheat Growers of Canada
PBI Policy Statement Near Final Objective: • The regulatory and policy environment for plant breeding innovation (PBI) must deliver on the dual objectives of driving innovation in the crop sector while maintaining market access abroad.
PBI Policy Statement Near Final • A whole-of-government commitment to support the introduction of PBI • A review of Canadian regulatory policies to ensure they: • are not overregulating, or causing a drag on domestic innovation • are delivering the decisions and transparency required to allow entry of products into the global marketplace • align with like-minded trading partners on the scope of regulated products • Proactive engagement with both like-minded and importing countries to drive a trade-enabling and risk-based global regulatory system • A Government of Canada public communication strategy
Other Domestic Initiatives • Benefits paper and supporting outreach activities • Focusing on 4 crops initially: canola, wheat, flax, lentil • Objective to clearly demonstrate and quantify the opportunity of PBI for these crops • Survey of Plant Breeders • Collect data about the impact of current Canadian regulations on R&D
International Initiatives and Forums • ISF: ongoing international leadership role on PBI, actively encouraging country-to-country discussion, most recently in London • IGTC: recently finalized a position on PBI, emphasizing need for regulatory alignment, and information sharing along the value chain, now situated to increase engagement on this issue • OECD: considering assessment of PBI products, workshop planned for 2018 • APEC: considering proposal for PBI dialogue among member economies • Extended like-minded governments forum led by USDA-FAS
Parting Thoughts • Budget 2017 sets an ambitious goal of growing Canada’s agri -food exports from $55 to $75 billion annually by 2025. • The Canada Grains Council and its members believe it is Canada’s strength in science that places this target within reach. • Only achievable if: • we don’t overregulate, inadvertently placing a drag on innovation • we know Canadian grain will meet foreign regulatory requirements and flow smoothly to international ports, this requires transparency and global regulatory coherence • we can build consumer comfort with PBI and the benefits it can bring to society
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