presentation - dagallier-nikaido - oecd and risk-safety assessment in modern biotechnology
TRANSCRIPT
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OECD AND RISK-SAFETY ASSESSMENT IN MODERN BIOTECHNOLOGY
COP/MOP8 side-event, 8th December 2016, Cancun, Mexico
Presented by Bertrand DAGALLIER and Takahiko NIKAIDOOECD, Environment, Health and Safety Division biosafety, novel food and feed safety
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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”
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What is the OECD?
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• 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)
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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)
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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 frameworksShare/disseminate common base of scientific information
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“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/cooperationbetween biosafety Authorities on current and new issues – meetings, workshops, other events
Databaseon transgenic products (approved for release in the environment and/or food and feed use) – available online
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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 SafetyConsensus Documents
Food/Feed SafetyConsensus 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)
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Consensus document: outputs
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Environmental Safety
Environmental ConsiderationsMolecular characterisationLow level presenceNew Plant Breeding Techniques
General documents on ES work
MicroorganismsTraits introduced
Information on
Crop plants Trees Mushrooms Fruits Animals (coming soon)
Biology of
Food/Feed Safety
Animal feedstuffsEmerging feed ingredients?
General documents on F/F S work
Crop plants Mushrooms Fruits Animals (in future?)
Composition on
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Overview of OECD Consensus Documents
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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
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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)
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Include information for use in food/ feed safety assessment of new varieties on compositional considerations:key NutrientsAnti-nutrientsToxicants*Allergens* (*: as relevant)
Novel Food and Feed Safety Consensus Documents
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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)
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OECD’s Work (consensus documents);
Database of commercialised GM products (OECD Product Database); and
Regulatory contacts in OECD countries.
BioTrack Online
http://www.oecd.org/biotrack/
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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
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Database - Unique Identifier
Key to accessing information in the OECD database and interoperable systems for the G.E. products
Applicant Event Verification 15
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Database – How it works (BioTrack)www.oecd.org/biotrack
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Database – How it works (by U.I.)
General InfoApprovals
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Database – How it works (by Organism)
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Database – How it works (by Company)
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Database – How it works (by Country)
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Database – How it works (by Trait)
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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
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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)
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Consensus Documents & Product database available at:
www.oecd.org/biotrack
Merci!