It’s going to be illegal in California to sell “gene-therapy kits” unless they carry a warning that says not to use them on yourself.
Just one wrinkle: we’re not sure any such kit exists. Not yet, anyway.
The consumer protection rule is in a bill signed by Governor Gavin Newsom on July 30 and will become law in January. It targets hobbyist kits employing CRISPR, the versatile gene-editing tool that has revolutionized gene research.
Sales of certain do-it-yourself CRISPR supplies will be prohibited unless they carry a bold notice “stating that the kit is not for self-administration.”
It’s the first law in the US to directly regulate CRISPR, says its author, Republican state senator Ling Ling Chang.
The law appears to take aim at a California resident, Josiah Zayner, whose Oakland company, The Odin, sells genetic-engineering supplies to amateurs online. He won notoriety in 2017 when he filmed himself injecting CRISPR into his own arm.
“It’s obviously targeting me,” says Zayner, an outspoken biohacker also currently under investigation by California Department of Consumer Affairs for practicing medicine without a license.
Asked for examples of products the bill could affect, Chang’s staff provided a link to an Amazon ad for a $159 box of supplies sold by Zayner, which “includes everything you need to make precision genome edits in bacteria at home.”
Because that kit targets genes in bacteria, however, it wouldn’t have any effect in humans, and it’s not clear why it would need a warning label. “It’s like saying a skateboard needs to have a sticker to say it can’t be used on the freeway. It doesn’t make any sense,” says Zayner.
MIT Technology Review was not able to find any product currently for sale by Zayner or others that would meet the definitions set up by Chang’s legislation.
In any case, the sale of do-it-yourself gene-therapy products is already prohibited. In 2017, the Food and Drug Administration said selling gene-editing products intended for self-administration “is against the law” because they haven’t been approved.
That was the year Zayner taunted health authorities by filming himself self-injecting gene-altering substances. Later, a separate startup company called Ascendance Biomedical said it planned to sell such independent gene treatments to the public.
Zayner’s injection was a publicity stunt, however. In practice, commercial gene therapy involves transferring genes into the body using billions of viral particles, which Zayner and other biohackers don’t sell and which are hard to make.
“We can’t even make enough for [medical] trials right now,” says Nicole Paulk, an assistant professor at the University of California, San Francisco.
Zayner says that starting in 2017 he did sell one CRISPR product that could target a human gene, the one that encodes a protein called myostatin. Removing that gene with CRISPR can enlarge the size of muscles. Zayner says he expected people might use the DNA instructions he was selling as a building block toward genetic enhancements.
However, he admits his customers misunderstood how many further steps would be involved, such as multiplying and purifying the CRISPR molecules. “People were buying it and sending us messages: ‘How do we inject this?’” says Zayner. He discontinued the product earlier this year.
Why pass a law to regulate a product that doesn't exist? One reason may be that California leads the world in both technology and legislative nannying.
Chang is the sponsor of numerous bills whose topics range from hit-and-runs by drones to microchipping cats and dogs at animal shelters. Via a spokesperson, she said she wanted to be “proactive” and is “concerned about amateur use [of CRISPR] and its impact on consumer safety and public health.”
Lobbyists familiar with the bill’s history say Chang’s staff became alarmed by news articles describing how CRISPR could be misused. These included an interview in Foreign Policy in which Jennifer Doudna, an inventor of the CRISPR tool, described the technology as racing forward without coordination or enough regulation.
“They said, ‘Oh my goodness, there seems to be an underground culture in DIY bio and DIY CRISPR,” says Oliver Rocroi, vice president for government affairs at the California Life Sciences Association, a trade group. He says a worry was that citizens would flush homemade genetically modified organisms down the toilet: “It was ‘Is there a contagion scenario where things spin out of control?'”
Rocroi said Chang’s staff at first “wanted an outright ban on DIY CRISPR kits,” but after the association pushed back, “they settled on a warning.”
“The downside of a ban is you are preventing people from carrying out experiments that could lead to something,” Rocroi said, explaining the association’s objection. “Like computers in the 1980s, we didn’t want to stop people from using the technology, even if it’s in their home.”
Arguably, a more well-founded worry for legislators is that consumers might emulate experienced biohackers like Zayner, urged on by his promotional videos. For example, a TV show called Jackass featured performers carrying out dangerous stunts, such as setting their farts on fire or being bitten by animals. Several teens died or were injured trying to make their own stunt videos. A “Jackass effect” in genetic modification could prove worrisome.
Zayner thinks legislators are just grandstanding. “It’s like, California, people try to find new technology to regulate, make a name, and say, ‘Hey, California is ahead of everyone else,’” he says. “To me the law is silly. Is it saying you can sell a CRISPR gene therapy, and all you have to do is write on it, ‘Not for human use?’”
You can find the text of Chang's CRISPR law below:
CHAPTER 37. Gene Therapy Kits: Notice
22949.50. Except as permitted by federal law, a person shall not sell a gene therapy kit in this state unless the seller includes a notice on the seller’s internet website in a conspicuous location that is displayed to the consumer prior to the point of sale, and on a label on the package containing the gene therapy kit, in plain view and readily legible, stating that the kit is not for self-administration.
22949.51. For purposes of this chapter, the following definitions apply:
(a) “Gene therapy” refers to the administration of genetic material to modify or manipulate the expression of a gene product, or to alter the biological properties of living cells, for therapeutic use.
(b) “Gene therapy kit” refers to a product that is sold as a collection of materials for the purpose of facilitating gene therapy experiments, including, but not limited to, a system for the targeted cutting of DNA molecules, such as type II clustered regularly interspaced short palindromic repeats (CRISPR), associated proteins (CRISPR-Cas) systems, including CRISPR-Cas9, as described in Regents of University of California v. Broad Institute, Inc. (2018) 903 F.3d 1286.