Josiah Zayner is a scientist and entrepreneur who quit his government job in a NASA lab to start The Odin, a synthetic biology company run out of his garage. For $150, anyone can now purchase the cutting-edge "gene editing" tool CRISPR (Clustered regularly interspaced short palindromic repeats) through The Odin's online shop.
Zayner champions do-it-yourself "biohacking" as the future of science and often draws comparisons between his work and that of the computer scientists and hackers of the '80s and '90s who eventually become the titans of Silicon Valley.
"I think [genetic engineering] is really going to become a consumer industry," says Zayner. "Consumers drive a lot of technological advancement."
Biohackers like Zayner, much like their computer hacker forebears, prefer asking for forgiveness rather than permission. And so far, Zayner hasn't had to do either. But the launch of a new product that allows users to engineer fluorescent yeast by inserting a gene from a bio-luminescent jellyfish drew the attention of the Food and Drug Administration (FDA) after officials learned that breweries were using the product to create glowing beer. They called up Zayner to discuss potential regulatory pitfalls.
Officials on the call, which Zayner recorded and posted on his YouTube channel, sound hesitant to make any hard-and-fast declarations about Zayner's work, but they do clearly express the opinion that the yeast modification constitutes a "food color additive," which is subject to pre-market approval by the agency. They instruct him that he should change the language on his website so that nobody construes the yeast as a food product. Zayner then asks them what will happen if he doesn't change anything, to which one of the officials replies,
"Well, there's a number of things that we could do, from a warning letter…to, where, if it got to the point where we would, you know, seize material."
They also tell him to keep track of who is buying the yeast kit and suggest that he could face "trouble" if breweries continue to use the product, even if he changes the marketing language.
"This is who I'm dealing with, a bunch of bullies," says Zayner. "Bullying people into doing what they want, not for scientific reasons, not for the betterment of the public…just because."
Zayner is not the only one in the genetics industry burdened with regulatory uncertainty. Another such case is that of Antony Evans at TAXA, a San Francisco-based synthetic biology company that aims to engineer plants to supplement or replace common household items. They currently have a glowing plant in development, which Evans envisions as an alternative to nighttime lighting, and fragrant moss that could act as an organic air freshener. He's had products jammed up by the FDA and the Environmental Protection Agency (EPA) in the past.
"If you're an entrepreneur creating a regulated article, the cost to getting that product to market is extremely high," says Evans. "That's why a lot of entrepreneurs are starting in the edges."
Evans believes that it's the pre-market approval process that stymies innovation among small, lean startups, which cannot afford to wait years and spend hundreds of thousands or millions of dollars to take a product to market. The FDA does allow products that only contain substances Generally Recognized as Safe (GRAS) to go straight to market, but Zayner and Evans both believe the list of GRAS substances is far too limited and the process for approval needlessly burdensome and time-consuming.
"We have no idea how much we are inhibiting [innovation], but we just know that we are because it's almost impossible to launch a plant GMO company."
Watch the full video above.
Produced by Zach Weissmueller by Alexis Garcia. Camera by Alex Manning and Weissmueller. Music by Jon Luc Hefferman.