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Presentation - Dagallier-Nikaido - OECD and risk-safety assessment in modern biotechnology


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Presentation by Bertrand Dagallier and Takahiko Nikaido, OECD experts, on OECD and risk-safety assessment in modern biotechnology.

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Presentation - Dagallier-Nikaido - OECD and risk-safety assessment in modern biotechnology

  1. 1. OECD AND RISK-SAFETY ASSESSMENT IN MODERN BIOTECHNOLOGY COP/MOP8 side-event, 8th December 2016, Cancun, Mexico Presented by Bertrand DAGALLIER and Takahiko NIKAIDO OECD, Environment, Health and Safety Division biosafety, novel food and feed safety
  2. 2. Organisation for Economic Co-operation and Development Intergovernmental, 35 member countries + other partners Deals with all aspects of economy, incl. governance, green growth, agriculture, environment, industry, trade… Advice to governments, information exchange, Analyse/compare data, harmonised practices and standards, recommends policies “Better policies for better lives” 1 What is the OECD?
  3. 3. • 35 Member Countries from Americas, Europe, Asia and Pacific Members and partners • + 5 Key Partners: Brazil, China, India, Indonesia, South Africa + Candidates: Colombia, Costa Rica, Lithuania OECD Biosafety work: Need for global collaboration Further countries involved: Argentina, Bangladesh, Kenya, Moldova, Paraguay, Philippines, Russia, Vietnam (others); and Observer organisations: UNEP, FAO, WHO, World Bank, ILSI-CERA, NEPAD-African Biosafety Network of Expertise, Industry, CGIAR Centres (& others) 2
  4. 4. 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
  5. 5. Purposes:  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
  6. 6. “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
  7. 7. 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
  8. 8. 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  Animals (in future?) Composition on
  9. 9. Overview of OECD Consensus Documents 8
  10. 10. Include information (for use in risk assessment) on the biology of crops and traits : Consensus Document- Content (Biosafety)  The use of the crop/ trait in agriculture practice  Taxonomy  Centre of origin and diversity  Reproduction  Wild relatives – hybridisation  Weediness 9
  11. 11.  Consensus documents on the Biology of - Tomato, - Eucalyptus, - Common bean, - Cowpea, - Grain sorghum Recent publications - Biosafety  Safety Assessment of Transgenic Organisms in the Environment – compendia of consensus documents (Vol. 5 and 6, April 2016)  Biosafety and the Environmental Uses of Micro-Organisms (2015: Proceedings of the 2012 Workshop)  Report of the OECD Workshop on ER/SA of Products derived from New Plant Breeding Techniques (2016) 10
  12. 12. Include information for use in food/ feed safety assessment of new varieties on compositional considerations: key Nutrients Anti-nutrients Toxicants* Allergens* (*: as relevant) Novel Food and Feed Safety Consensus Documents 11
  13. 13.  Consensus document on the composition of common bean: key food and feed nutrients, anti-nutrients and other constituents (2015)  of rice (2016, revising the 2004 doc) Recent publications – food & feed safety  Safety Assessment of Novel Foods and Feeds – Compendia of consensus documents - Volumes 1 & 2 (2015) 12
  14. 14.  OECD’s Work (consensus documents);  Database of commercialised GM products (OECD Product Database); and  Regulatory contacts in OECD countries. BioTrack Online 13
  15. 15.  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 To date (Dec. 2016): 251 products from 12 “countries” (incl. EU), 12 crops + 2 flowers species Product Database - Content 14
  16. 16. Database - Unique Identifier Key to accessing information in the OECD database and interoperable systems for the G.E. products Applicant Event Verification 15
  17. 17. Database – How it works (BioTrack) 16
  18. 18. Database – How it works (by U.I.) General Info Approvals 7
  19. 19. Database – How it works (by Organism) 18
  20. 20. Database – How it works (by Company) 19
  21. 21. Database – How it works (by Country) 1 20
  22. 22. Database – How it works (by Trait) 21
  23. 23.  Official data only – publicly available  “Approved” material only : clear “boarders” of content  Simple to use: one product at a glance for description, countries, legal decisions  Browse by: -Unique Identifier, -Species -Country, -Applicant company, Database - Positive points/specific strengths 22
  24. 24.  Limited resources (financial & human)  Voluntary basis input – not always complete, not always latest recent info  Technical issues (collaboration with other databases; CBD Biosafety Clearing House, FAO GM Foods Platform) Database – Limits/challenge FUTURE ADDITIONS: from other countries, and permanent update EXTENSION to other species [trees, micro-organisms, animals (extend Unique Identifier) 23
  25. 25. Consensus Documents & Product database available at: Merci!