Risk and safety assessment in modern biotechnology

OECD and Risk/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 geneticallyengineered 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.

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 Please cite this paper

Biology of plant species: see table

as:

Document on the OECD (2009), “Consensus Plantains (Musa spp.)”, Biology of Bananas and of Regulatory Oversight Series on Harmonisation Environment Directorate. in Biotechnology No. 48,

Series on Harmonisation Biotechnology, n° 48

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Consensus Document on the Biology of Bananas spp.) and Plantains (Musa

Environment Directorate

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

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Compendium of Environmental Safety Consensus Documents, Volumes 1 to 4

safety Assessment ms of Transgenic Organis

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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 (20092014) Coming soon!

PRODUCT DATABASE The OECD Product Database allows regulatory officials to easily share basic & approval information on products from modern biotechnology (geneticallyengineered 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.