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OECD activities related to modern techniques of biotechnology and genome editing

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This presentation highlights OECD's activities related to modern techniques of biotechnology including genome editing in light of previous OECD conferences and workshops and technical products, such as consensus documents.

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OECD activities related to modern techniques of biotechnology and genome editing

  1. 1. An Overview of OECD Activities Related to Modern Techniques of Biotechnology and Genome Editing OECD Conference on Genome Editing, June 2018 Presented by Peter Kearns on behalf of OECD
  2. 2. 1) ENVIRONMENTAL safety of GEOs (biosafety) Working Group for the Harmonisation of Regulatory Oversight in Biotechnology 2) FOODS/FEEDS derived from GEOs Working Group for the Safety of Novel Foods and Feeds OECD Bio&Food safety work: 2 programmes Aim: Help to address human health and environmental safety issues, through science-based risk assessment, for products of modern biotechnology (G.E.O.s): plants, animals, micro-organisms These groups are composed of bio/food safety National Authorities: regulators, risk assessors & experts, (and observers from Organisations) 3
  3. 3. Purpose:  Assist countries to evaluate potential risks of modern biotech. products for human-animal health and environment, and ensure high standards of safety  Limit duplicative efforts: mutual understanding, acceptable data  Reduce the potential for non-tariff barriers to trade OECD Biosafety Work Basic Principles Means: Harmonisation of approaches and regulatory frameworks Share/disseminate common base of scientific information 4
  4. 4. “Consensus” and Guidance Documents - to help national assessment and decision-making process - practical tools for comparing conventional and “GE” products - available online OECD Biosafety Work Main Outputs Exchange/cooperation between biosafety Authorities on current and new issues – meetings, workshops, other events Database on transgenic products (approved for release in the environment and/or food and feed use) – available online 5
  5. 5. Consensus documents Is this new food-feed as safe as its conventional counterpart? OECD docs collate key composition elements on foods and feeds issued from G.E. organisms, with compiled data, for possible comparison. The elements are considered --and completed-- at national level. Environmental Safety Consensus Documents Food/Feed Safety Consensus Documents On which features should my environmental RA be based on? OECD docs provide info. on what should be considered for risk assessment of G.E. organisms to be released in the environment. The elements are considered --and completed-- at national level.  Scientific information reference, internationally recognised, a common basis  However NOT prescriptive (= not a compulsory standard) 6
  6. 6. Consensus document: outputs 7 Environmental Safety Environmental Considerations Molecular characterisation Low level presence New Plant Breeding Techniques General documents on ES work Microorganisms Traits introduced Information on  Crop plants  Trees  Mushrooms  Fruits  Animals (coming soon) Biology of Food/Feed Safety Animal feedstuffs Emerging feed ingredients? General documents on F/F S work  Crop plants  Mushrooms  Fruits  Atlantic salmon  Aedes aegyptii Composition on
  7. 7.  Contains Information related to G. E. Products (Unique Identifier, parental crop, introduced trait, developer name…) Approvals (approval date, usage type, authority name, link to decision/risk assessment…)  Information provided on a voluntary basis by biosafety National Authorities;  Validated and uploaded by OECD Secretariat Product Database - Content 14
  8. 8. Gene Editing in the Directorate for Science, Technology and Innovation (OECD STI)
  9. 9. ‘Gene Editing in an International Context: Scientific, Economic and Social Issues across Sectors’ BNCT Workshop on Gene Editing • 29th – 30th September 2016, Ottawa, Canada • Attendees from 14 countries, industry, academia, and pressure groups • Objective: – Information exchange and cross-disciplinary discussion on the science, governance, and economics of gene editing innovations in: • Applications in Agriculture & Aquaculture • Environmental Applications, and • Applications in Human Medicine
  10. 10. Applications of Gene Editing (1) 10 Current Applications: •Health / Medicine: – Fast, targeted breeding of mouse models (e.g. 2 years shortened to 4 months) for advanced understanding of the roles of specific genomes and cures for genetic disorders, or for fertility studies with human embryo cells (cf. Francis Crick Institute, UK, February 2016) – Study of the gene-editing tool itself (i.e. safety issues, off-target effects, efficacy, etc.) (cf. China, April 2015) – Trials to eradicate malaria-transmitting mosquitos (by making them infertile / preventing mating / infecting them with bacteria / etc.) •Agriculture: – Fast, targeted breeding of plants with special resistances (e.g. drought resistance), or with special abilities (e.g. self-fertilization or self-pollination), or for special purposes (e.g. therapeutic applications) •Environment: – Studies to inhibit the spreading of invasive species (e.g. farmed salmon)
  11. 11. Applications of Gene Editing (2) 11 (potential) Future Applications: •Health / Medicine: – Treatment of diseases (i.e. by elimination of genetic mutations that cause a disease, or by modification of human somatic (i.e. non- reproductive) cells): HIV/Aids, haemophilia, sickle-cell-anaemia, some cancers, etc. – Elimination of heritable genetic diseases from a family line (i.e. by KO- or repair of the human germ line in embryonic cells) • Agriculture: – Fast, targeted and ‘cheap’ breeding of plants and animals with specific desirable attributes (cf. super-muscly pigs created by deleting a gene, which inhibits muscle growth, versus the Belgian Blue beef bred through traditional breeding techniques) Taken from: http://www.nature.com/news/super-muscly-pigs-created-by-small-genetic-tweak-1.17874 “Super-muscly pigs created by small genetic tweak.” (Nature 523 (2015) 13-14).
  12. 12. For more information on For more information on OECD Gene Editing Activities: OECD Gene Editing Activities: Please see the Please see the poster in the foyer poster in the foyer
  13. 13. Genome editing Conference web site: www.oecd.org/environment/genome-editing-ag Thank you!