Regulatory challenges posed by synthetic biology

1 June 2014

The J. Craig Venter Institute (JCVI) has released a new report on synthetic biology and the US regulatory environment for biotechnology.


The JCVI is a non-profit genomics research institute founded by J. Craig Venter, the shotgun DNA sequencing pioneer who led the private company Celera Genomics to complete the first draft human genome sequence alongside the international Human Genome Project. Describing itself as a ‘multidisciplinary genomic-focused organization’, the JCVI encompasses research in genomic medicine, microbial, plant and environmental genomics; and synthetic biology and bioenergy, as well as related ethical, legal and social issues.


The new report from the JCVI, University of Virginia, and EMBO, examines the regulatory challenges posed by the rapid development of synthetic biology and genetic engineering technologies.


It concludes that the US government bodies tasked with regulatory oversight of the field (including the Food and Drug Administration) have sufficient legal powers to address most (though not all) health, safety and environmental concerns that might arise, developments such as the rising use of complex genetically engineered microbes could overwhelm them.


It was suggested that additional funding and new methods of fast-track evaluation and appraisal were needed by the Environmental Protection Agency (EPA) and the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS)

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