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The FDA Is Cracking Down On Rogue Genetic Engineers

A fluorescent cat engineered by scientists using jelly fish genes. Image: Nature
A fluorescent cat engineered by scientists using jelly fish genes. Image: Nature

David Ishee’s plan was simple, if not exactly free of complication. From the shed that functions as his laboratory in rural Mississippi, he hoped to use genetic engineering to rid dogs of the types of terrible disorders caused by decades of high-end breeding.

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Now, on top of the obvious scientific hurdles, Ishee has a new challenge to contend with: the FDA.

Ishee is a biohacker, one among a growing number of do-it-yourself scientists that the federal government is having an increasingly difficult time figuring out what to do with.

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Since the DIY bio community first developed in the early aughts, it has largely avoided government regulation. But in 2017, cheaper equipment and simpler genetic engineering technologies mean that garage scientists can dream much bigger than simply turning yellow yeast red. We now live in a world where anyone can order custom DNA sequences on the internet to tinker with in their home. And the rules that govern genetic engineering today were not written with the foresight that it would one day be possible for 30-year-old hobbyists in Mississippi to try their hand at genetically engineering dogs.

Biohacker David Ishee with mastiffs he has bred to lessen genetic disorders. Image: David Ishee
Biohacker David Ishee with mastiffs he has bred to lessen genetic disorders. Image: David Ishee

Ishee joined the ranks of DIY biohackers after becoming frustrated with the limits of traditional dog breeding. He breeds mastiffs—huge, friendly dogs that are known to be riddled with genetic disorders. Over a few generations, Ishee has used traditional techniques to breed out many troublesome conditions, such as the sagging skin and oversized head that make many mastiffs look goofy. But some recessive conditions, like hip dysplasia, could not simply be bred away.

And so for $1,000, two years ago he built a lab in his backyard shed capable of doing everything from culturing tissue to altering the DNA of canine sperm. Then he began trying to attack his dog breeding problems with genetic engineering. He is currently experimenting with different ways he might modify the DNA before artificially inseminating female dogs. In an early test to see whether his methods work, he fused sperm with genes from glowing bacteria in an attempt to engineer glowing puppies, though the pregnancy failed to take. Undeterred, he’s now gearing up to tackle even bigger challenges.

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But he hit a roadblock earlier this month, when the FDA proposed a new rule that would require any genetically engineered animal go through a strict regulatory procedure. In essence, the FDA wants to define any animal a scientist purposefully genetically modifies as a “drug.” That means that if a scientist say, created cows without horns that are safer to farm, those cows would have to go through a vetting process similar to new drugs.

Ishee was preparing for a project that sought to cure hyperuricemia in Dalmatians—a common liver malfunction that frequently results in kidney stones, bladder stones or gout.

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“It should be straight forward,” he told Gizmodo. Ishee plans to use the gene-editing technique CRISPR to correct the single errant nucleotide that causes the condition, reversing the mutation to turn a T in the genetic code back into the correct G. Then he’ll use a technique called sperm-mediated gene transfer, which will allow him to transfer his engineered Dalmation DNA to a female Dalmation, resulting, he hopes, in a fertilized egg that’ll produce hyperuricemia-free pups.

“The animals just get molecular surgery to fix a broken gene that causes their bladders to explode,” he said. “Then those animals can become the founders on a healthy generation of Dalmatians and breed the disease away in a few years.”

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Under the proposed FDA rules, Ishee can still continue experimenting in his shed. But if enacted, the rules mean that should Ishee ever sell his Dalmatians, they will be subject to strict regulation. When the FDA first published the rules, some scientists freaked out, worrying that they might make animal genomics unfeasible for anyone other than large, cash-rich corporations.

For Ishee, who has not yet decided whether to continue with his experiments, the rules would make the science less accessible. “It’s regulation to control who can use these new technologies and how much money they need to have to use them, not regulation to mitigate any risks,” he said.

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Ishee is not the first biohacker to run into regulatory roadblocks. Last month, the FDA intervened after finding out that a Bay Area biohacker was selling kits for homebrewers to genetically engineer their own glowing beer, questioning whether the green fluorescence protein used to make the beer’s yeast glow was a color additive for food that had yet to be recognized as safe for consumption. (Its creators argue that aside from not being a color, there’s little evidence to suggest there are safety issues.) At Body Hacking Con, a biohacker conference in Austin last weekend, a frequent topic of concern was how best to approach government regulation. Regulations for implants typically only apply when the implant is considered a “medical device,” but the magnets and RFID chips body hackers gravitate toward don’t fall into that category.

“The FDA has made a continuous effort to better understand the needs of the developer community and has instituted a number of activities aimed at providing assistance to regulated small businesses,” the agency said in an emailed statement to questions about its views on the biohacker community. It added that the agency has a “number of programs” to help “small businesses navigate the regulatory system.”

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As people move beyond implanting magnets, it seems inevitable that future devices will face regulation. Amal Graafstra, who owns Dangerous Things, a company that makes chip implants for biohackers, said that he initially pursued voluntary regulatory approval for new devices, but gave up because the process was too confusing and expensive.

“If [the FDA] was organized for accessibility, smaller organizations could get involved,” he said. “But I don’t have half a million dollars for an expert to help me through that process.”

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Mead brewed with a genetically engineered green fluorescent yeast that glows under a blacklight. IIMAGE: Josiah Zayner
Mead brewed with a genetically engineered green fluorescent yeast that glows under a blacklight. IIMAGE: Josiah Zayner

Part of the trouble is that even before biohackers came along, agencies like the FDA struggled to regulate new technologies, finding bizarre ways of applying old rules to new tech. (Like, perhaps, considering green fluorescent protein a “color additive.”)

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Until now, though, DIY biohackers have evaded much government suspicion, mainly because the tight-knit community has built up strong, self-imposed policies of ethics and safety, encouraging people to stick to experiments that are safe for people and the environment. There are no explicit consequences for not following the guidelines, but so far, the system seems to have worked. At least, the community has been small enough and niche enough to avoid attracting the attention of potentially bad actors.

But advancing scientific tools and a growing DIY bio movement mean that some of these projects are moving out of the garage and into the consumer world. The Odin sells its DIY glowing beer kits online for $160, along with all kinds of other supplies for Easy Bake genetic engineering. Ishee hopes to one day sell his lab-perfected pups to others, too.

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This has amped up concerns, bringing to a head a long-standing and heated debate over how DIY science should be regulated.

DIY scientists argue that imposing more rules will make new technologies less accessible, and many in the scientific community agree that home-brewed biohacking poses little threat. Others find it hard to dispel the image of a lone scientist in a garage somewhere accidentally creating a deadly pathogen and unleashing it upon the world. Whether or not that scenario is likely, it make sense that scientists—amateur or not—be subject to some form of oversight when they plan to sell their work to the public.

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For Ishee, the question is not whether he should be regulated. In fact, he initially reached out to the FDA voluntarily. He takes his hobby seriously, and wants to do everything possible to ensure that his science is ethical, lawful and safe. Instead, Ishee is concerned that rules designed without a growing contingent of DIY biology enthusiasts in mind will be so taxing that they render newly accessible science once again inaccessible to everyone without a fancy degree and a high-end lab.

Ishee’s project is a long shot. Still, if he manages to actually engineer disease-free dogs, he sees it as a crime that he wouldn’t be able to share his results with the world.

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Update: The story has been updated to include a response from the FDA.

Senior Writer, Gizmodo.

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DISCUSSION

The biggest problem I see - especially in the light of 45's presence, is that he’s not going to “deregulate” because the regulation is stifling, he’s going to deregulate in order to support corporate business.

Corporate Businesses would emphatically NOT want competition from garage scientists. At all.

This goes far, far beyond the ephemeral threat of biohacking. State sponsored actors are going to be the ones who accidentally or intentionally create the first engineered bioweapon with modern tools - because that will be their mandate. No. This will be precisely in the form it is to prevent small businesses and groups from being able to challenge the dominion of large corporations.

Like the scare with 3-d printed guns. People have long had easy ways to produce workable weapons for really cheap. Some of these methods, which can involve your local hardware store, a hacksaw, and a bit of elbow grease, would be far more effective and capable than any weapon printed from a plastic filament printer.

The 3-d printer was brought up though specifically because it doesn’t just reflect a method of producing a questionable quality weapon - but it also reflects a method of producing cheap, small parts that can then be used to extend the life of tools and equipment with built-in obsolescence. That was the greater crime in the eyes of several manufacturers who prefer people actually purchase new equipment every few years rather than owners self-repairing older equipment that they (the corporations) can no longer directly make money from.

45 is a protectionist. And the people he protects are most like himself. And thus, I fully expect that people actually studying such “frivolous” things in their garage will be cracked down upon. Not because they are a threat or a potential source of harm, but because they would be a danger to the profits of industries that depened on sickness and illness to drive their domination and success.