The Food and Drug Administration issued, just two days before the end of the Obama administration, draft guidance on how the agency proposes to regulate genomically altered food animals. The FDA claims authority to regulate livestock and their products developed using the fantastically precise and versatile new genome editing techniques like CRISPR. Ultimately, the FDA's guidance document is rife with scientific nonsense.
First, the overreaching agency claims it has the authority to regulate genetically improved livestock as a "new animal drug." As the agency points out all new animal drugs are "deemed unsafe" unless it has approved a new animal drug application. Treating each version of new improved livestock as a drug is really bad news for developers and consumers, since it takes years for a new drug to get through the FDA process at an average cost of more than $1 billion. Consider that it took the agency 20 years to approve the Aquabounty salmon that was genetically engineered simply to grow faster.
The new FDA proposal is also ridiculously bad science. In fact, the regulation of modern biotech crops has been based on bad science for nearly three decades. Researchers have pleaded for years that regulation, if needed, be based on whether the end product poses novel risks, not on the method by which it is created. Under the new idiotic FDA guidance, any intentional change to a single-nucleotide base pair would make the entire animal a regulated drug. Let's put this into perspective. DNA, the chemicals that make up genes, are safe to eat. Unless you are eating only things like processed pure sugars and some minerals (in which case you'd be dead by now), nearly everything you eat contains DNA. In fact, by one estimate you eat more than 100 trillion genes that are in your food every day. Eating the DNA that specifies the production of snake venom is no more dangerous than eating any other DNA (even eating snake venom isn't necessarily dangerous, but I personally wouldn't advise it).
Genetically improved livestock like hornless Holstein dairy cows are now in the FDA regulators' crosshairs. Researchers at the University of California, Davis used precise genomic editing to change the horn gene in Holstein dairy cattle to match the hornless gene found in Angus beef cattle. Most dairy cattle are dehorned as a way to keep them from harming farmers. As someone who has dehorned both calves and cattle, I can tell you that the animals don't enjoy the experience. This gene editing actually advances animal welfare. Since it is safe to eat hornless Angus cows, it is also safe to eat and consume dairy products from now hornless Holstein cows. Yet, the proposed FDA guidance wants the developers to go through its whole new drug regulatory rigamarole before products from these genetically improved animals can be offered to the public. This is on top the the FDA regulations that have stymied biotech advances in crop agriculture for decades.
As Alison van Eenennaam, one of the researchers who developed the hornless Holsteins tells Gizmodo: "If DNA is a drug, then all life on Earth is high." She adds, "We have equivalent products with the same risks. Human intention isn't where risk lies. 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."
The FDA guidance blandly observes:
In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required.
As the former head of the Obama administration's White House Office of Information and Regulatory Affairs Cass Sunstein notes today over at Bloomberg News: "In theory, people are free to ignore guidance documents. If a company violates mere guidance, it cannot be punished. But in practice, any such violation is risky, because it will trigger the agency's attention, and officials might decide to take action. It's usually prudent just to comply." Sunstein continues: "These pleas should be heeded. Guidance documents are sometimes ill-considered—and they can wreak havoc." This guidance is particulary ill-considered.
The Trump administration has floated lots of different potential nominees to head up the FDA. There are plenty of useless regulatory blockages to progress that need to be swept away at the agency, but whoever eventually gets the nod should order this scientifically illiterate bit of guidance to be withdrawn immediately.
For more background, see my column, "CRISPR Critters: Regulators and the New Gene Revolution in Agriculture."