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

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?

• 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

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

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!