Dairy cows grow horns. But dairy cows in the U.S. rarely have horns because they are seared, cut, or chemically burned off in a process that is as painful as it sounds. When Scott Fahrenkrug, then an animal scientist at the University of Minnesota, learned about dehorning, he decided to apply his genetics expertise to creating a hornless dairy cow. And he left academia job to co-found a company, Recombinetics.
Fahrenkrug and his team ended up using a relatively new gene-editing technique called TALENs. They took a hornless gene from a breed of beef cattle and inserted it into a breed of dairy cattle. The resulting cattle are hornless, good at producing milk, and still genetically 100 percent cattle. In the past, breeders could have crossed dairy cattle and hornless beef cattle to get hornless dairy cattle after many generations. Gene editing is much, much faster, but the end results are genetically almost the same. Does this kind of gene-editing still need to be regulated?
The answer is yes, according to proposed guidelines released by the Food and Drug Administration this week. In an accompanying blog post that cites Recombinetics’s hornless cows, the FDA made clear that it could regulate any “portion of an animal’s genome that has been intentionally altered” as an animal drug. Recombinetics, as far as the FDA is concerned, has essentially been making animal drugs with its hornless cows. This is naturally not the decision the company was hoping for. “We disagree with this guidance and will be doing our best to change this,” Fahrenkrug told me this week. Scientists have also used gene-editing techniques to create pigs resistant to various viruses, though Recombinetics’s cows appear to the closest to commercialization.