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

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. 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?

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)
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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)
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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
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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
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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)
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8. Consensus document: outputs
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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. Overview of OECD Consensus Documents
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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
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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)
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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
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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)
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14.  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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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
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16. Database - Unique Identifier
Key to accessing information in the OECD database and
interoperable systems for the G.E. products
Applicant Event Verification
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17. Database – How it works (BioTrack)
www.oecd.org/biotrack
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18. Database – How it works (by U.I.)
General Info
Approvals
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19. Database – How it works (by Organism)
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20. Database – How it works (by Company)
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21. Database – How it works (by Country)
1
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22. Database – How it works (by Trait)
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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
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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)
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25. Consensus Documents & Product database
available at:
www.oecd.org/biotrack
Merci!