Animal cloning and genetic modification: A prospective study
Researcher Name: Ann Bruce
Affiliated Staff: Principal investigator: Joyce Tait
Associated staff:
Catherine Lyall,
Renate Gertz (AHRC Research Centre for Studies in Intellectual Property and Technology Law), Jonathan Suk (Genomics Forum)
Project Start Date:
Project End Date:
Contact Details: Ann Bruce , ESRC Innogen Centre, University of Edinburgh, High School Yards, EH1 1LZ, UK
Funder: Co-funded by Eurpoean Science and Technology Observatory (ESTO)
Background: Innogen was invited to tender for this study by ESTO, based in the EC Institute for Prospective Technology Studies (IPTS) in Seville. Our ability to link with a team of eminent scientists based in Roslin Institute and the Genesis Faraday Partnership in Roslin, along with the legal expertise of our colleagues in the AHRB Law Centre, were instrumental in our being awarded the contract.
Aims and Objectives:
To provide a comprehensive picture of R&D and commercial activities involving animal cloning and/or genetic modification and their products, worldwide
To provide evidence on the pipeline of products for the next five years
To identify the potential socio-economic impacts (benefits and risks) and new policy implications of the development of these technologies and of the commercialisation of their products in the EU
To compare the regulatory frameworks and visions worldwide
Research Methods: The study will covered applications of the technology, including food production, molecular pharming, xeno-transplantation, the pet sector, sporting animals and endangered species. We reviewed of the main R&D actors and products in the market and in the pipeline will be worldwide in order to anticipate potential safety, trade and competitiveness implications.
Key Findings: The key findings related to cloned animals are indicated below:
The widely held view among industry insiders is that meat and milk derived from the offspring of cloned cattle and pigs are likely to enter the food chain somewhere in the world before 2010. The emergence of food products derived from animal cloning raises numerous ethical and policy issues One of the main barriers to commercial uptake of cloned elite animals is perceived as market acceptability and the pending regulatory assessment by the Food and Drugs Administration in the United States.
The likely impact of existing legislation in the EU on products from cloned animals is unclear at the moment e.g. it is not clear if cloned animals will be classified as genetically modified organisms and therefore subject to Directives such as 2001/18/EC governing the commercial release of genetically modified organisms.
There is currently no scientific method (and no obvious basis) for distinguishing between meat and milk from non-cloned and cloned animals (or from the offspring of cloned animals). Thus any labelling requirements related to the products of cloned animals would need to rely upon traceability regimes.
No clear international agreements covering trade in semen and embryos from cloned livestock are in place, although some companies are actively working in this area.
The lack of consistency poses a potential barrier to the animal biotech industry but may also increase the likelihood of public resistance.
Wider implications for policy:
Project Update:
Publications: The main findings from this project were published in the January 2007 issue of Nature Biotechnology:
Suk, J., Bruce, A., Gertz, R., Warkup, C., Whitelaw, C.B.A., Braun, A., Oram, C., Rodríguez-Cerezo, E., Papatryfon, I. (2007), Nature Biotechnology 25(1): pp 47-53.
Project reports: Three reports were produced for the Institute for Prospective Technological Studies (IPTS) Seville:Animal Cloning and Genetic Modification: A Prospective Study (1) - R&D and commercialisation activitiesAnimal Cloning and Genetic Modification: A Prospective Study (2) - Cloned animals Socio-economic issuesAnimal Cloning and Genetic Modification: A Prospective Study (3) - GM animals Socio-economic issues
External Links:
Further information: Contact Ann Bruce: ann.bruce@ed.ac.uk
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