OECD andRisk/Safety Assessment in Modern Biotechnology

Food, Feed and Environmental Safety

All publications available on

www.oecd.org/biotrack

The SAFETY of products derived from modern biotechnology is a challenging issue as genetically-engineered crops are increasingly cultivated, and foods or feeds derived from them are marketed worldwide.

Modern biotechnology products are rigorously assessed by governments to ensure high safety standards for environment, human food and animal feed. Such assessments are felt essential for a healthy and sustainable agriculture, industry and trade.

Modern biotechnology is applied to crop plants, and also trees, animals and micro-organisms.

PARTICIPANTS

OECD programmes on risk / safety assessment of biotechnology products involve:

- OECD member countries

- Non-member economies: Argentina, Brazil, China, India, Indonesia, Philippines, Russia, South Africa, others.

- International Organisations: FAO, WHO, UNEP Convention on Biological Diversity, Codex Alimentarius, others.

- Observers: The Business and Industry sector, World Bank/CERA, CGIAR centres, NEPAD West Africa, others.

OECD “CONSENSUS DOCUMENTS”

The OECD Consensus Documents are useful to applicants for commercial uses of transgenic organisms, to national regulators and risk assessors, as well as the wider scientific community.

Please cite this paper as:

OECD (2009), “Consensus Document on the

Biology of Bananas and Plantains (Musa spp.)”,

Series on Harmonisation of Regulatory Oversight

in Biotechnology No. 48, Environment Directorate.

Environment Directorate

Series on Harmonisation of Regulatory Oversight in

Biotechnology, n° 48

Consensus Document on the Biology of Bananas

and Plantains (Musa spp.)

These practical tools compile science-based information relevant to risk/safety assessment of transgenic varieties intended for release in the environment. In addition, key composition elements (e.g. nutrients, toxicants) are used to compare novel foods and feeds with conventional ones. These documents are published after consensus is reached among countries, in two Series: Environmental safety, and Food/Feed safety.

Environmental Safety

Biology of plant species: see table

Traits: Virus resistance (Coat Protein); Glyphosate and Phosphinothricin herbicides tolerance; Bacillus thuringiensis (Bt) insect control.

Microorganisms: Pseudomonas; Acidithiobacillus; Baculoviruses; Acinobacter; Bacteria: taxonomy, detection methods, horizontal gene transfer, pathogenicity factors.

In progress: “Considerations” relevant to environmental risk/safety assessment; biology of Atlantic salmon, Mosquito (Aedes aegypti).

Food and Feed Safety

Composition of plant species: see table

Others: Safety assessment of animal feedstuffs derived from transgenic plants.

Further reading:

- Introduction to Biosafety Consensus Documents- Points to Consider for Consensus Documents on the

Biology of Cultivated Plants- Introduction to Food & Feed Safety Consensus

Documents.- Molecular Characterisation of Transgenic Plants- Low Level Presence of Transgenic Plants in Seeds &

Grains

www.oecd.org/publishing

isbn 978-92-64-09543-4

97 2010 16 1 P -:HSTCQE=U^ZYXY:

safety Assessment of Transgenic Organisms

OECD COnsEnsus DOCumEnTs

Volume 3

The books on “Safety Assessment of Transgenic Organisms” constitute a compilation of the

OECD Biosafety Consensus Documents. When published, Volume 1 and 2 contained the documents

issued before 2006; Volume 3 and 4 are a continuation of the compilation up to 2010.

The OECD Biosafety Consensus Documents identify elements of scientific information used in the

environmental safety and risk assessment of transgenic organisms which are common to OECD

member countries and some non members associated with the work. This is intended to encourage

information sharing, promote harmonised practices, and prevent duplication of effort among

countries.

These books offer ready access to those consensus documents which have been issued on the

website thus far. As such, it should be of value to applicants for commercial uses of transgenic

organisms (crops, trees, micro-organisms), to regulators and risk assessors in national authorities,

as well as the wider scientific community.

More information on the OECD’s work related to the biosafety of transgenic organisms is found

at BioTrack Online (http://www.oecd.org/biotrack).

Further reading

Safety Assessment of Transgenic Organisms – OECD Consensus Documents, Vol 1 (2006)

Safety Assessment of Transgenic Organisms – OECD Consensus Documents, Vol 2 (2006)

Related reading

The Bioeconomy to 2030: Designing a Policy Agenda (2009)

La bioéconomie à l’horizon 2030: quel programme d’action ? (2009)

OECD Biotechnology Statistics 2009 (2009)

Cutting Costs in Chemicals Management: How OECD Helps Governments and Industry (2010)

Réduire les coûts de gestion des produits chimiques : Comment l’OCDE aide les gouvernements

et l’industrie (2010)

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Please cite this publication as:

OECD (2010), Safety Assessment of Transgenic Organisms: OECD Consensus Documents: Volume 3,

OECD Publishing.

http://dx.doi.org/10.1787/9789264095434-en

This work is published on the OECD iLibrary, which gathers all OECD books, periodicals and statistical

databases. Visit www.oecd-ilibrary.org, and do not hesitate to contact us for more information.

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PUBLICATIONS - Compendia

Compendium of Environmental Safety Consensus Documents, Volumes 1 to 4

Volumes 1 and 2 contain the documents issued before 2006; Volumes 3 and 4 continue the compilation up to 2010.

Compendium of Food and Feed Safety Consensus Documents, Volumes 1 (2002-2008) and 2 (2009-2014) Coming soon!

PRODUCT DATABASE

The OECD Product Database allows regulatory officials to easily share basic & approval information on products from modern biotechnology (genetically-engineered plant varieties), and products with novel traits. These products have been already approved for commercial application (for food, feed or environmental safety) in at least one country.

All consensus documents and the Product Database are available at no charge, on the OECD’s Website:

www.oecd.org/biotrack

OECD PROGRAMMES ON RISK / SAFETY ASSESSMENT OF BIOTECHNOLOGY PRODUCTS

1. The Working Group on the Harmonisation of Regulatory Oversight in Biotechnology deals with environmental safety of transgenic organisms;

2. The Task Force for the Safety of Novel Foods and Feeds focuses on foods or feeds derived from transgenic organisms.

Purpose of the two programmes:

1. to assist countries evaluating the potential risks of transgenic products (plants, animals, micro-organisms) and ensure high standards of safety;

2. to foster communication and mutual understanding of relevant regulations in countries; and

3. to facilitate harmonisation in risk/safety assessment of biotech products, reducing costs and potential for non-tariff barriers to trade.