‘Do-it-yourself’ CRISPR kits. How much should we worry?

crisprkit+resize-edFrom the European Centre for Disease Prevention and Control website.

«On 24 March 2017, German authorities reported the contamination of a ‘do-it-yourself’ (DIY) Bacterial Gene Engineering CRISPR kit with pathogenic bacteria (risk group 2), including some that are multidrug-resistant with production of Extended Spectrum Beta-Lactamase (ESBL). The kits are produced in the United States and sold over the internet, targeting non-professional users who want to study biology and life science using similar biotechnology engineering tools found in laboratory settings. In its risk assessment published today, ECDC identifies the risk of infection for users of the kits unaware of the contamination with pathogenic agent as low, as the manipulation of the kit does not involve percutaneous injury-prone manipulations.

However, infection resulting from the contamination of broken skin or mucous membranes may occur, even though the kit recommends and provides disposable gloves. The contribution of the kit to antimicrobial resistance in the EU/EEA population and environment is marginal. As a result of this contamination event, German authorities have banned the importation of the kit. National competent authorities in the EU should review the authorisation of this commercial DIY Kit (CRISPR-Cas 9) product, or similar ‘citizen science’ biomaterials containing risk group 1 biological agents to produce genetically modified micro-organisms for educational or recreational purposes on the basis of the applicable European and national legislation.
Member States may also encourage consumers of such kits to purchase them from companies that have implemented quality control procedures and that follow proper packaging, labelling, and documentation requirements for transport of biological materials, such as stated in the WHO ‘Guidance on regulations for the Transport of Infectious Substances’. At this stage, it is estimated that the distribution of such contaminated kits is very limited. The assessment of the risk associated with the DIY kits should be revised should further information indicate that the distribution of the kit extends more widely across the EU.»


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