California clamps down on amateur use of gene-editing technologies

California state officials have passed the first law to prohibit genetic biohacking in an effort to regulate the controversial practice. The new law warns biohackers not to edit their own genes and makes it illegal to sell do-it-yourself genetic engineering kits unless they clearly state that they are not to be used for self-administration.

California has banned at-home gene editing kitsStunningArt | Shutterstock

California wants to make it clear that tampering with your own genes is not something that people you should be trying to do “at home.”

The advent of the powerful gene-editing tool CRISPR has led to a biohacking movement that has got people interested in tinkering with their own genes for the purpose of self-enhancement.

The issue has prompted legislators in California to regulate the practice and last month Governor Gavin Newsom signed a bill authored by Republican state Senator Ling Chang that is the first to address the amateur use of gene-editing technology.

The requirement that the kits carry a clear warning stating that they must not be used for self-administration will become law from January next year.

I’m proud to announce the Governor signed my bill addressing human biohacking. CRISPR is becoming widely available, but many in the scientific community have sounded the alarm that it could have negative consequences outside professional labs. This first ever legislation addressing emerging CRISPR technology will help prevent safety mishaps by amateur users of CRISPR kits.”

Ling Chang, Senator

People can now use the technology in kitchens and garages

Emerging genetic engineering technologies are quickly becoming widely available and cheap enough for biohacking hobbyists to start using them at home, a development that has scientists and public officials worried about how to restrict the sale of home gene therapy kits.

The term “biohacking” can refer to a wide range of do-it-yourself approaches to biology, from experimenting on yeast, for example, to giving yourself a fecal transplant.

The type of biohackers that are currently causing the most concern is a subsection of hobbyists who are increasingly carrying out experiments to enhance themselves, with procedures ranging from self-prescribing drugs to boost performance through to installing sense-enhancing cybernetic implants.

Now, the increasing availability of CRISPR technology has meant it is being used in kitchens and garages by a growing number of biohackers who want to stretch the very limits of what it means to be a human being by altering their own genomes.

Current regulations were not designed to make sense of such a phenomenon, which means many biohacking pursuits lie within a legal grey zone where organizations such as the FDA largely frown upon them but know they are not yet classed as illegal. With such activities not yet enforced as outright illegal, regulators are struggling to keep up with biohackers.  

CRISPR kit company owner prompted FDA to clamp down

The owner of one company called DIY CRISPR Kits, Josiah Zayner, was recently investigated by California’s Department of Consumer Affairs and by California state officials for practicing medicine without a license.

Zayner’s company, called The Odin, sells kits for use outside of the lab that enable users to genetically modify anything from bacteria to humans.

Zayner is well known for using biohacking to modify himself. In 2016, he attempted a DIY fecal transplant in an airport hotel and has also tried to genetically modify his own skin.

However, he is perhaps most well-known for trying to modify his muscle growth. Using a CRISPR-Cas9 gene editing kit, he tried to alter his myostatin gene, which plays a role in regulating muscle growth. Disabling the gene could have boosted Zayner’s muscle growth enough to leave him with more muscle bulk.

Weeks after Zayner attempted this, the FDA got involved and issued a notice calling the kits illegal, which included the following statement:

The FDA is aware that gene therapy products intended for self-administration and ‘do-it-yourself’ kits to produce gene therapies for self-administration are being made available to the public. The sale of these products is against the law. FDA is concerned about the safety risks involved.”

State officials are trying to neutralize the danger

Now, officials in Zayner's home state of California have also weighed in. The new bill signed by Newsom is a sign that people are becoming increasingly concerned about biohacking and are trying to neutralize the danger by introducing more regulation.

Politicians such as Chang and agencies such as the FDA want to be proactive about regulating a technology that could pose a risk to public health if amateurs inspired by people like Zayner use it irresponsibly.  

How effective such action will remain to be seen because even if clear regulations are introduced, there would be no bullet-proof way to stop people using the technologies behind closed doors, the more commoditized and easily accessible they become.

However, until scientists understand more about DNA and the potential dangers of tampering with it, regulations designed to discourage DIY gene editing are the best way to safeguard against the potential dangers.

Rather than restricting access to the technologies, Chang is choosing to inform consumers of the risks of using them for self -administration. She relayed via a spokesperson that her aim is to be “proactive” because she is “concerned about amateur use [of CRISPR] and its impact on consumer safety and public health.”

Sources:
Sally Robertson

Written by

Sally Robertson

Sally has a Bachelor's Degree in Biomedical Sciences (B.Sc.). She is a specialist in reviewing and summarising the latest findings across all areas of medicine covered in major, high-impact, world-leading international medical journals, international press conferences and bulletins from governmental agencies and regulatory bodies. At News-Medical, Sally generates daily news features, life science articles and interview coverage.

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