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

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, 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)

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• 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

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Biosafety challenge

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)

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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. 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

Purposes of the two programmes

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 EXCHANGE/Cooperation between biosafety Authorities and

• bserver 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…)

OECD bio/food safety work: main outputs

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Discussions initiated in the 70’s, programme since 1995. 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.

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OECD Bio/food safety Work

Environmental Safety Food/Feed Safety

Output of these programmes

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• Consensus documents
• Crop plants
• Trees
• Mushrooms
• Fruits
• Animals
• Microorganisms
• Traits introduced
• Molecular characterisation
• Low level presence
• Environmental considerations

Biology of General documents on ES work Information on

• Consensus documents
• Crop plants
• Mushrooms
• Fruits
• Animals (in future?)
• Animal feedstuffs
• Emerging feed ingredients?

Composition General documents on F/F S work

Consensus documents: Tools for risk assessment

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.

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• Scientific information reference, internationally

recognised, a common basis

• However NOT prescriptive (= not a compulsory standard)

Consensus documents: Tools for risk assessment

• Nutrients
• Anti-nutrients
• Toxicants
• (Allergens)
• (Secondary metabolites)

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
• Biotechnology developments

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Biology Knowledge/ Familiarity Safe use history Composition: comparative approach of components

• Consensus documents on the Biology of
• eucalyptus, - cassava, - common bean,
• cowpea, - grain sorghum

Recent publications - biosafety

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• 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)

• 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

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• Safety Assessment of Novel Foods and

Feeds – Compendia of consensus documents - Volumes 1 & 2 (March 2015)

Under development

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

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

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

Example:

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

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• 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

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?

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Consensus Documents & Product database available at:

www.oecd.org/biotrack

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Thank You

OECD’s Biosafety Team: Peter Kearns; Takahiko Nikaido; Bertrand Dagallier; Mika Hosokawa

Contact: bertrand.dagallier@oecd.org