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Identification of potentially hazardous human gene products in GMO risk assessment

Published online by Cambridge University Press:  03 April 2008

Hans Bergmans
Affiliation:
GMO Office, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
Colin Logie
Affiliation:
Nijmegen Department of Molecular Biology, Nijmegen Center for Molecular Life Sciences, Radboud University, Nijmegen, The Netherlands
Kees Van Maanen
Affiliation:
Animal Health Service, Deventer, The Netherlands
Harm Hermsen
Affiliation:
Centre for Biological Medicines and Medical Technology, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
Michelle Meredyth
Affiliation:
Departments of Genomics, Biotech and Internal Medicine I, Technical University Dresden, Germany
Cécile Van Der Vlugt
Affiliation:
GMO Office, National Institute for Public Health and the Environment, Bilthoven, The Netherlands

Abstract

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Genetically modified organisms (GMOs), e.g. viral vectors, could threaten the environment if by their release they spread hazardous gene products. Even in contained use, to prevent adverse consequences, viral vectors carrying genes from mammals or humans should be especially scrutinized as to whether gene products that they synthesize could be hazardous in their new context. Examples of such potentially hazardous gene products (PHGPs) are: protein toxins, products of dominant alleles that have a role in hereditary diseases, gene products and sequences involved in genome rearrangements, gene products involved in immunomodulation or with an endocrine function, gene products involved in apoptosis, activated proto-oncogenes. For contained use of a GMO that carries a construct encoding a PHGP, the precautionary principle dictates that safety measures should be applied on a “worst case” basis, until the risks of the specific case have been assessed. The potential hazard of cloned genes can be estimated before empirical data on the actual GMO become available. Preliminary data may be used to focus hazard identification and risk assessment. Both predictive and empirical data may also help to identify what further information is needed to assess the risk of the GMO. A two-step approach, whereby a PHGP is evaluated for its conceptual dangers, then checked by data bank searches, is delineated here.

Type
Research Article
Copyright
© ISBR, EDP Sciences, 2008

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