As the end-of-the-world-as-we-know-it approached last week and the entire internet devolved into a morass of Trump headlines, the Food and Drug Administration quietly put forth proposed regulations that could drastically impact whether genetically engineered food winds up on your dinner plate in the future.
The FDA and other federal agencies have struggled with how to regulate new forms of genetic engineering. Alterations made with newer and more precise techniques, like CRISPR, often fall outside the purview of rules written when genetic engineering meant adding some fish genes to a strawberry in an attempt to make the crop cold-hardy. But the guidelines designed to fix this conundrum contain wording sure to make you scratch your head: In the future, the FDA would like to regulate any animal whose genome has been intentionally altered as an "animal drug."
Before your eyes glaze over and you accept a fate of never fully understanding the swampy backwaters of government regulation, I'm here to explain why this will be important if Trump's eventual FDA appointee choses to move forward with it.
In a narrow sense, the proposed rules signal a pretty significant regulatory crackdown on genetically engineered animals. The FDA would like any animal a scientist purposefully genetically engineers — say, to create cows without horns that are safer to farm — to go through a regulatory process similar to that for new drugs. Such a process, you can imagine, is both time consuming and expensive. It means that those genetically engineered hornless cattle could take many, many years before they are ever available to farmers. For this reason, scientists are freaking out.
The rules are also a great example of the kinds of insane workarounds regulators often rely on in order to gain oversight of new technologies.
The FDA defines a drug extremely broadly as any article "intended to affect the structure or any function of the body of man or other animals." Here, the FDA has taken that broad definition and made its application even more sweeping. At present, when it comes to genetically engineered animals, the FDA only considers what's known as recombinant DNA as a drug. This makes some degree of sense, since rDNA usually involves taking DNA from one organism and putting it into another to create a totally synthetic combination — like those Franken-fishtomatoes. The new rules, however, would apply in cases in which scientists were using genetic engineering to more efficiently breed a trait that already exists in nature, like the hornless dairy cattle that researchers announced last May. Under the new rules, any animal DNA intentionally edited by man for any reason, becomes a drug.
"This is definitely squeezing everything into the definition of a drug," Hank Greely, a bioethics expert at Stanford, told Gizmodo via email.
Or, as UC Davis animal geneticist Alison van Eenennaam put it, "if DNA is a drug, then all life on Earth is high."
Van Eenennaam and other scientists take issue in particular with the word "intentional" in the proposed regulations. In beef cattle, for example, folks have successfully bred hornless cattle by simply crossbreeding cows that naturally do not have horns. In dairy cows, they have had less luck, making genetic engineering an attractive alternative. The two cows, scientists argue, could wind up with the exact same genetic coding for horns — just achieved via two different methods. So why should one undergo a strict regulatory approval process and the other no approval process at all?
"We have equivalent products with the same risks. Human intention isn't where risk lies," van Eenennaam said. "Who would say a Holstein is a drug? It's a bull without horns. There's no normal person that would think that's a drug."
In a report last year, a National Academies report came to similar conclusions, finding that over time the distinction between traditional breeding and genetic engineering has become less obvious. To make matters even more confusing, the USDA has, at least for the time being, taken a different approach than the FDA in regulating genetically-engineered plants, suggesting that when engineered foods do not introduce foreign DNA into the plant, they fall outside of the purview of regulators. That's two completely different schools of regulatory thought for what essentially boils down to the same scientific process.
Scientists are afraid that the proposed rules could have a chilling effect on research and development of genetically-engineered animals, making it too expensive and complicated for universities and non-profit organisations to undertake.
Van Eenennaam pointed to the story of AquaBounty Technologies, a company that spent $US60 ($79) million developing a genetically-engineered salmon in the early 1990s. It was only after 20 years and more than 50 safety studies that the FDA finally approved the fish in November 2015. Even now, the company is still waiting on the FDA to decide whether it must be labelled as genetically modified before it can be sold.
"It's just frustrating," van Eenennaam said. "There's a really powerful new technology we could use to help solve problems like disease resistance and now it's going to be difficult to use."
What's most problematic is that defining a genetically engineered animal as a drug may actually be the best way for the FDA to gain oversight of these new technologies under existing regulations.
"They're forced into these words," Todd Kuiken, a senior research scholar with the Genetic Engineering and Society Center at North Carolina State University, told Gizmodo.
Kuiken said that the FDA may have sought overly broad regulations to ensure that they still apply to whatever new technologies are developed in the future.
"They have to use the laws already available to them now," he said. "That's the reality."
What scientists like van Eenennaam are calling for is a system that evaluates the safety of an end product rather than the method scientists used to create it. The question, in other words, should not be whether genetically engineered hornless cattle are safe, but whether milk or meat from hornless cattle is safe to consume.
It's unclear when or in what form the new rules, released in draft form two days before Trump's inauguration, may actually take effect. The agency is currently seeking public comment on the rules, as well as input from the scientific community on whether certain types of genome editing poses less risk than others. When pressed for comment by Gizmodo, the FDA reiterated details of the regulations announcement.
"Ideally something like this would be the a stop gap until a good new statutory scheme could be worked out," Greely said. "I can't say I'm optimistic, though."