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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.
972010161cov.indd 1
02-Nov-2010 1:32:27 PM
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.