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17.03.2020 |

New report: strict regulation of new genomic techniques is scientifically necessary

Environmental impacts of CRISPR/Cas and its challenges for risk assessment

17 March 2020 / In a new report, Testbiotech provides an overview of the latest research developments in environmental risk assessment and new methods of genetic engineering (also known as ‘genome editing’ or ‘new genomic technicques’). The authors come to the conclusion there are imperative scientific reasons for all organisms derived from these new techniques to undergo mandatory risk assessment before they can be released or marketed. Therefore, regulation requirements foreseen by current GMO law in the EU must be mandatory whether or not additional DNA sequences are inserted. In addition, a broad range of ethical and social issues must be taken into account by the regulatory decision-makers.

The report focuses on possible impacts that new methods of genetic engineering (genome editing) can have on the environment. It is primarily concerned with CRISPR/Cas nucleases classified as ‘site directed nucleases’ SDN-1 and SDN -2. These applications are not meant to introduce additional gene sequences. Nevertheless, the pattern of intended and unintended changes and the resulting new combinations of genetic information arising from genome editing will, in most cases, be different in comparison to those derived from conventional breeding. These differences co-occur with biological characteristics and risks that need to be fully investigated before any conclusions on the safety of the new organisms can be drawn.

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