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Canadian Regulatory Aspects of Gene Editing Technologies - Christine Tibelius

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This presentation addresses the regulatory questions associated with genome editing applications in agriculture in Canada, with a view to discussing approaches to address them.

Publicado en: Medio ambiente
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Canadian Regulatory Aspects of Gene Editing Technologies - Christine Tibelius

  1. 1. © 2017 Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited. Canadian Regulatory Aspects of Gene Editing Technologies Christine Tibelius, Director OECD Conference on Genome Editing June 29th, 2018
  2. 2. • Area of great interest in Canada – trade & regulation – government – stakeholders: industry, academia, research institutes • Hosted workshop on “Gene editing in an international context: scientific, economic and social issues across sectors”, September 2016 in conjunction with OECD – OECD Science, Technology and Industry Working Paper 2018/04 • Participated in industry led workshop on new plant breeding techniques including gene editing, in May 2017 Gene Editing
  3. 3. Biotech-Related Oversight in Canada Lead Product Regulation Canadian Food Inspection Agency Livestock feed Feeds Act Seeds Seeds Act Fertilizer Fertilizers Act Veterinary biologics Health of Animals Act Health Canada Pesticides Pest Control Products Act Novel foods, drugs, and biologics, medical devices Food and Drugs Act ECCC, HC, DFO Animals and all other substances Canadian Environmental Protection Act AAFC, GAC, ISED Non-regulatory considerations Market access, industrial policy, socio-economic impacts, trade ECCC – Environment & Climate Change Canada; DFO - Fisheries & Oceans Canada; AAFC – Agriculture &Agri-Food Canada; GAC – Global Affairs Canada; ISED – Innovation, Science &Economic Development Canada
  4. 4. Same trait, regardless of technology (process) Canada regulates PRODUCTS Breeding X Random Mutagen X Targeted Mutagen X Transgenic (GMO) X Since there are many paths to the same result, the consistent and risk-based regulatory approach is to regulate products, not processes. Canadian Regulatory Approach Genetic Deletion X
  5. 5. Canadian Regulatory Approach • Canada requires a pre-market safety assessment for agriculture biotechnology products, including products produced through gene editing, only if they are novel (i.e., express a new characteristic) and could therefore pose a new risk. • Canada does not require a pre-market safety assessment for products gene-editing, that do not express a novel trait.
  6. 6. Risk-Based Regulatory Approach Risk-Appropriate Regulation • Pre-market assessment required for “novel” products • Not every product would be considered ‘novel’ in terms of environmental release (e.g., Orange petunia) Flexibility of Information Requirements • Not prescriptive • Case by case • Outcome based
  7. 7. Regulation of a Novel Plant Product Product i.e. Canola with Herbicide Tolerance CFIA – Novel Feed HC – Novel Food CFIA – Plants with Novel Traits
  8. 8. Authorization Process Novel Food Assessment (Health Canada - Food & Drugs Act) Livestock Feed Assessment (CFIA – Feeds Act) Environmental Assessment (CFIA – Seeds Act) Authorization For Livestock Feed Use No Objection For Human Food Use No-split approval policy Other non-PNT/GMO regulatory requirements (e.g. Variety Registration) Commercialization Authorization For Unconfined Environmental Release
  9. 9. Regulatory Pathway • Cultivation of plants and use as food and feed are regulated under different pieces of legislation that have different purposes • The regulatory triggers for novel foods, novel feeds and plants with novel traits (PNTs) are somewhat different • Different regulatory triggers specific to novel foods, novel feeds and PNTs is important • This ensures that developers are only subject to the regulatory oversight that is required and appropriate for their particular product
  10. 10. Unconfined Environmental Release Plants with a novel traits (PNTs) are defined as: • Plants into which one or more traits have been intentionally introduced, and • Where the introduced trait is both new to cultivated populations of the species in Canada and has a potential to affect the specific use and safety of the plant with respect to the environment and human health • Risk assessments consider 5 pillars: • Potential for weediness • Consequences of gene flow • Becoming a plant pest • Impact on non-target organisms • Biodiversity
  11. 11. Unconfined Environmental Release • The assessment is comparative • Does the addition of novel trait(s) change the plant’s impact on the environment in comparison to the same crop being grown in an agricultural setting? • Authorized products have been assessed and found to be as safe as comparable products with a history of safe use • Allows the release of a PNT into the environment with limited or no restrictions • May require stewardship plans
  12. 12. Sustainability – Stewardship Requirements • Stewardship plans include strategies allowing for environmentally safe and sustainable use of PNTs • Plans consider recent available scientific evidence, communication with growers, efficient reporting of problems to the developer, and monitoring • Stewardship plans include: • Herbicide tolerant management • Insect resistance management • Disease resistance management
  13. 13. Novel Feeds • Any feed ingredient that is new (i.e. not listed in the Regulations), or has been modified such that it differs from conventional parameters, is required to undergo a pre-market assessment • Only feed ingredients that have been approved and evaluated by the CFIA may be used in livestock feeds; approved ingredients are listed in Schedules IV and V of the Feeds Regulations • Feeds with novel traits can be developed by such methods as traditional breeding, mutagenesis, cell fusion, recombinant DNA techniques, etc. • Products derived from Biotechnology (microbial, plant or animal sources) are treated the same as non-biotech feeds
  14. 14. Novel Food Definition • A substance, including a microorganism, that does not have a history of safe use as a food • A food that has been manufactured, prepared, preserved or packaged by a process that: • has not been previously applied to that food, and • causes the food to undergo a major change
  15. 15. Novel Food Definition • A food that is derived from a plant, animal or microorganism that has been genetically modified such that: • the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism • the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or • one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism
  16. 16. Breakdown of Authorized Crop Kinds Corn 31% Soybean 17% Brassica napus 12% Cotton 12% Wheat 7% Potato 6% Rice 4% Sunflower 2% Alfalfa 2% Brassica rapa 2% Sugar beet 2% Brassica juncea 2% Apple 1% Flax 1% Lentil 1% Sorghum 1% Note: “Novel crop kinds” include both GM and non-GM novel crops (mutagenesis, etc.)
  17. 17. Guidance on PNTs, Novel Feed and Novel Food • Plain language Questions and Answers about gene editing-derived PNTs – a work in progress • Existing Guidance on Novelty • For PNTs - Dir2009-09 • For animal feed, the guidance can be requested through Afd_daa@inspection.gc.ca • Existing Guidance on data requirements
  18. 18. Animals • In Canada, genetically modified animals are regulated under the Canadian Environmental Protection Act for potential environmental or indirect human health concerns. • No specific policy on gene editing yet but inquiries are coming in. • Will need to carefully examine the resulting organism for all genetic changes – case-by-case RA.
  19. 19. Stakeholder Engagement • Proponents are encouraged to contact regulatory authorities early in the product development process to discuss: • Potential regulatory requirements (Pre-submission consultations) • Novelty determinations • Regulators regularly engage with stakeholders: • Biotechnology working groups • Technical meetings with industry and academia
  20. 20. Regulatory Challenges • Some plant or animal products modified through use of gene editing may be considered novel in Canada and not regulated in other jurisdictions • Regulatory asymmetry, asynchronous approvals may increase complexity • Canada is committed to ensuring that new technologies do no face obstacles to innovation while ensuring sufficient oversight to protect public interest, and is consulting with value chain stakeholders to ensure that our regulatory system continues to perform well as new technologies emerge
  21. 21. Socio-economic Factors • Are not considered within our risk assessment frameworks • Upon approval, a novel product is considered to be equivalent to its conventional counterparts • Producers are free to choose amongst products deemed to be safe and to implement the production methods and marketing strategies of their choice
  22. 22. Take Home Messages • Since there are many biotechnological techniques that can be used to achieve the same result, the consistent risk-based regulatory approach is to treat comparable products alike. • Canada regulates PRODUCTS, which may include some products of plant or animal breeding innovations (e.g. CRISPR). • Canada’s regulations have the flexibility to include evolving technologies, when a product is novel. • Ultimately, this is a system that allows for consistent decision-making and a clear regulatory path, which are both essential to supporting innovation.
  23. 23. For more information concerning novel products Health Canada Web address: https://www.canada.ca/en/health-canada.html Feed Web address : http://www.inspection.gc.ca/animals/feeds/eng/1299157225486/132053 6661238 Environmental Release (PNT) Web address: http://www.inspection.gc.ca/plants/plants-with-novel- traits/eng/1300137887237/1300137939635

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