OECDS PROGRAMMES ON ENVIRONMENTAL SAFETY AND FOOD/FEED SAFETY - PowerPoint PPT Presentation

BUILDING BIOSAFETY CAPACITY: OECD’S PROGRAMMES ON ENVIRONMENTAL SAFETY AND FOOD/FEED SAFETY ASSESSMENTS 1st AFRICAN BIOSAFETY LEADERSHIP SUMMIT Nairobi, Kenya, 15-16 August 2016 Bertrand Dagallier, OECD ENV/EHS

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

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

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

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

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

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

OECD Bio/food safety Work Discussions initiated in the 70’s, programme since 1995. Di verse 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

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

Consensus documents: Tools for risk assessment Environmental Safety Food/Feed Safety Consensus Documents Consensus Documents On which features should my Is this new food-feed as safe as its environmental RA be based on? conventional counterpart? OECD docs collate key composition OECD docs provide info. on what elements on foods and feeds issued should be considered for risk from G.E. organisms, with compiled assessment of G.E. organisms to be data, for possible comparison. released in the environment. The elements are considered --and The elements are considered --and completed-- at national level. completed-- at national level.  Scientific information reference, internationally recognised, a common basis  However NOT prescriptive (= not a compulsory standard) 10

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

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

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

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 2016 14

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

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) • 2012-2014: 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 co-lead NEPAD-ABNE (with Brazil and ILSI-CERA) Grain sorghum co-lead South Africa (with United States) Cowpea proposed by AATF (Kenya), based on its existing biology document Mosquito A. aegypti 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

Conclusions • Scientific information/ data can be shared for use in science- based 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

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