First CRISPR law targets DIY gene therapy kits

California has passed the first-ever bill regulating genome editing technology that targets do-it-yourself CRISPR kits.

The new law, which will come into force in January 2020, requires that any genome editing kits have a clear label for consumers that says that the kit is 'not for self-administration'.

'CRISPR technology is becoming widely available to the public but many in the scientific community have sounded the alarm that it could have negative consequences outside professional labs,' says Senator Ling Ling Chang, author of the bill. 'While I'm a huge proponent of supporting scientific curiosity and imagination, I'm very concerned about the amateur use of this technology and its impact on consumer and public safety.'

DIY genome editing kits are typically designed for experiments on bacteria or yeast that allow consumers to conduct a small-scale science project at home. Some are concerned that the easy access to CRISPR via these kits could lead to consumers self-administering their experiments.

The kits are sometimes associated with a broader 'biohacking' movement, in which some amateur scientists design technological or biological human enhancements outside of traditional research institutions. The movement aims to democratise access to science, but a small number of more extreme proponents have tried using genome editing on themselves, notably Josiah Zayner who injected himself with CRISPR reagents at a conference in 2017. Zayner previously marketed a kit which used CRISPR to target a gene associated with human muscle development but has since withdrawn the kit from sale.

Since there are currently no kits for sale in California that are intended for human use, and the sale of such kits is prohibited in the United States by the FDA already, the bill has been described as 'proactive' more than addressing a current practice.

'The technology is moving faster than regulations, so it's important to be proactive about preventing safety mishaps by amateur users of CRISPR kits,' said Chang.