BUILDING BIOSAFETY CAPACITY: OECD S PROGRAMMES ON ENVIRONMENTAL SAFETY AND FOOD/FEED SAFETY ASSESSMENTS

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1 BUILDING BIOSAFETY CAPACITY: OECD S PROGRAMMES ON ENVIRONMENTAL SAFETY AND FOOD/FEED SAFETY ASSESSMENTS 1st AFRICAN BIOSAFETY LEADERSHIP SUMMIT Nairobi, Kenya, August 2016 Bertrand Dagallier, OECD ENV/EHS

2 What is the OECD? 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 2

3 Members and partners 35 Member Countries from Americas, Europe, Asia and Pacific + 5 Key Partners: Brazil, China, India, Indonesia, South Africa + Candidates: Colombia, Latvia, Costa Rica, Lithuania OECD Biosafety work: Need for global collaboration Further countries involved: Argentina, Banglasdesh, Kenya, Paraguay, Philippines, Russia, Thailand, Vietnam (others); and Observer organisations: UNEP, FAO, WHO, World Bank, ILSI-CERA, NEPAD-African Biosafety Network of Expertise, Industry, CGIAR Centres (& others) 3

4 Biosafety challenge Genetically-engineered organisms (G.E.Os) increasingly produced and used in many parts of the world Expected to be rigorously assessed for environmental safety (biosafety) and food and feed safety Regulatory frameworks established or under development in many countries; costly International cooperation can help by sharing experience and increase efficiency 4

5 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 1) ENVIRONMENTAL safety of GEOs (biosafety) Working Group for the Harmonisation of Regulatory Oversight in Biotechnology 2)FOODS/FEEDS derived from GEOs Task Force for the Safety of Novel Foods and Feeds These groups are composed of bio/food safety National Authorities: regulators, risk assessors & experts, (and observers from Organisations) 5

6 Purposes of the two programmes 1. Assist countries in evaluating the potential risks of modern biotech products (environment/food&feed), and ensure high standards of safety 2. Foster communication and mutual understanding of relevant regulations in countries 3. Facilitate harmonisation in risk/safety assessment practices and regulations (limits duplication of efforts, reduces costs, less barriers to trade) Help (but do not replace) country decisions on GEOs 6

7 OECD bio/food safety work: main outputs EXCHANGE/Cooperation between biosafety Authorities and observer Organisations on current and new issues Consensus Documents to help national assessment and decision-making process - practical tools for guiding the assessment, with science-based information internationally-recognized available online DATABASE on ~ 250 transgenic products (approved for release in the environment/cropping and/or food and feed use) - 15 species -11 countries+ EC need to be completed (Asian and African countries ) 7

8 OECD Bio/food safety Work Discussions initiated in the 70 s, programme since Diverse views on GEOs, strong debates, but: "let us build on what is common": share scientific knowledge; learn from other safety assessment practices and regulations; collate and exchange data; develop tools agreed together to favour harmonisation. Country participation and use of OECD outputs for RA, are on a volontary basis, not prescriptive or legally-binding. And agreements by consensus. Slow pace to develop projects & to agree on documents Solid and well-balanced guidance, useful tools for RA based on official sources, internationally recognised. 8

9 Output of these programmes Environmental Safety Consensus documents Biology of Crop plants Trees Mushrooms Fruits Animals Food/Feed Safety Consensus documents Composition Crop plants Mushrooms Fruits Animals (in future?) Information on Microorganisms Traits introduced General documents on ES work General documents on F/F S work Animal feedstuffs Emerging feed ingredients? Molecular characterisation Low level presence Environmental considerations 9

10 Consensus documents: Tools for risk assessment Environmental Safety Consensus Documents Food/Feed Safety Consensus Documents On which features should my environmental RA be based on? Is this new food-feed as safe as its conventional counterpart? 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. 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. Scientific information reference, internationally recognised, a common basis However NOT prescriptive (= not a compulsory standard) 10

11 Consensus documents: Tools for risk assessment Biology Knowledge/ Familiarity Safe use history Composition: comparative approach of components Environmental Safety Consensus Documents Food/Feed Safety Consensus Documents The use of the crop/trait in agriculture Taxonomy Reproduction Wild relatives hybridisation Centre of origin and diversity Weediness Nutrients Anti-nutrients Toxicants (Allergens) (Secondary metabolites) Biotechnology developments 11

12 Recent publications - biosafety Consensus documents on the Biology of - eucalyptus, - cassava, - common bean, - cowpea, - grain sorghum Biosafety and the Environmental Uses of Micro-Organisms (2015: Proceedings of the 2012 Workshop) Safety Assessment of Transgenic Organisms in the Environment compendia of consensus documents (Vol. 5 and 6, April 2016) 12

13 Recent publications food & feed safety 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) Safety Assessment of Novel Foods and Feeds Compendia of consensus documents - Volumes 1 & 2 (March 2015) 13

14 Under development Biosafety: Coming soon: biology of Tomato; Atlantic salmon Mosquito Aedes aegypti; (Anopheles in future?) Micro-algae used for production purpose Environmental considerations for the safety of transgenic crops Novel Food-Feed Safety: Composition of Apple; Cowpea; revised Maize; Innovative feed ingredients (coordinated with FAO) Food & Feed issued from GE animals, points to consider in RA (in future?) For both Programmes: New plant breeding techniques Exchange of information. Do they pose new challenges to RA? High-throughput DNA Sequencing: Workshop proceedings to be published end

15 Example: BioTrack Product Database 250 G.E. products (with unique identifiers), 15 species, regulatory information on approvals from 12 countries + EC. General Info Approvals 15

16 Specific involvement from Africa in OECD Bio/Food safety activities South Africa, Kenya and NEPAD-ABNE participate regularly in the programmes (South Africa is member of the Food TF Bureau) : World Bank-OECD-ILSI CERA Partnership for Biosafety Risk Assessment and Regulation. Has allowed participation from Bangladesh, Kenya, Colombia and Paraguay. Develop the biology document for cassava and common bean Development of consensus documents: FOOD & FEED SAFETY Cassava lead South Africa Grain sorghum co-lead South Africa (lead United States) Sweet potato co-leads South Africa and Japan Experts from Nigeria and Ghana proposed for future Cowpea and revised Maize docs BIOSAFETY Cassava Grain sorghum Cowpea Mosquito A. aegypti co-lead NEPAD-ABNE (with Brazil and ILSI-CERA) co-lead South Africa (with United States) proposed by AATF (Kenya), based on its existing biology document contribution Kenya Work and expertise from CGIAR Centres incl. those based in Africa (ICRISAT, IITA, CIAT, CIMMYT ) and others (ISAAA ) used as inputs & key references 16

17 Conclusions Scientific information/ data can be shared for use in sciencebased risk assessment Existing international documents & databases are useful and save resources National regulatory decisions may differ from each other (for legitimate reasons) Exchanges with other bio/food safety Authorities improve safety and leads to efficiency: importance of regional networks (e.g. ABNE, ANBAA, COMESA-ACTESA ) To go further: Share full risk assessments/joint reviews? Accept RA data from other countries? 17

18 Thank You Consensus Documents & Product database available at: OECD s Biosafety Team: Peter Kearns; Takahiko Nikaido; Bertrand Dagallier; Mika Hosokawa Contact: bertrand.dagallier@oecd.org 18