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Biohackers May Soon Be Under The FDA’s Watchful Eye

Genetics is about to get regulated.

Dom GaleonFebruary 6th 2017

Vetting Modified Animals

Genetic engineering is proving to be an increasingly useful tool, effective at everything from protecting plant species to helping humans battle disease. It’s also getting progressively easier to harness, which is why we’re seeing a quickly growing community of do-it-yourself genetic engineers (or biohackers) emerge. Many of these DIY scientists are focused on improving animal species for better breeding, but some skeptics are afraid some well-intentioned scientist somewhere might accidentally home-brew a deadly pathogen or open some other sort of Pandora’s box of genetic devastation.

To this end, the U.S. Food and Drug Administration (FDA) is moving to regulate the work done by these so-called rogue genetic engineers. They’ve now released a revised draft of their guidelines for regulating animals with intentionally altered genomic DNAs. Prepared by the FDA’s Center for Veterinary Medicine, the guide covers animals that have been produced using any genome editing technologies or genetic engineering.

“This guidance addresses animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal,” the draft reads. “This guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration.”

Genetically engineered florescent cat. Credits: Nature
Genetically engineered florescent cat. Credits: Nature

Regulation Woes

As expected, this isn’t sitting well with DIY geneticists. Biohacker David Ishee uses genetic engineering to attempt to rid dogs of many of the disorders that go along with high-end breeding.  In an interview with Gizmodo, he said that he knows that what genetic hobbyists like him do is actually beneficial. Plus, it’s not that complicated. “It should be straightforward,” he said. “The animals just get molecular surgery to fix a broken gene that causes their bladders to explode. Then those animals can become the founders on a healthy generation of Dalmatians and breed the disease away in a few years.”

The new FDA rule, however, makes it difficult for Ishee and his fellow biohackers to continue with their efforts. Granted, the proposed regulation by the FDA would allow them to keep working in their make-shift labs, but they would be required to have their genetically modified products vetted by the FDA in the same way that the agency regulates new drugs. Scientists are worried that this might make animal genomics feasible only for large, cash-rich corporations and thus limit innovation. “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,” Ishee said.

The FDA, on the other hand, argues that what it’s doing isn’t meant to hinder the work done by these biohackers. “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,” according to an emailed statement sent by the agency to Gizmodo.

But it isn’t like these DIY geneticists have been doing things however they want. They practice self-regulation, with strong ethics and safety policies that make sure none of their experiments harm people or the environment. Now, with the FDA involved in home-based genetic engineering, biohackers like Ishee can’t help but feel uneasy. “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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