This Genetics Company Is Editing Horns Off Milk Cows

Recombinetics says its genetically edited Holsteins are ready to milk, but FDA rules are in flux.

Fahrenkrug’s team is making livestock healthier, fleshier, and, yes, less pointy. 

Photographer: Hannah Walker Smith/Cornell Alliance for Science

Geneticist Scott Fahrenkrug knows a callipyge when he sees one. The term, which means “beautiful buttocks” in Greek, is often used by livestock breeders to describe a mutation that causes an animal’s post­erior to grow to twice the average size for its species, meaning more juicy, flavorful meat.

Fahrenkrug saw his first callipyge in the 1990s, when he was working at an obscure U.S. Department of Agriculture facility charged with finding ways to predict which individual animals could be bred to produce the meatiest offspring. “Genetic improvement faster—that really was always the objective,” he recalls. Seeing the USDA’s back-heavy sheep, and some unusually well-muscled bulls, led him to start thinking about shortcuts, like the advanced tools he’d seen used to tweak fly and worm genes in his grad school lab. “I knew that once you know the mutation and you understand the biology,” he says, “you can exactly produce the outcome.”

If that sounds obvious in the age of Crispr, it didn’t 20 years ago, when American farmers were meticulously breeding meatier cows, sheep, pigs, and goats over decades. Fahrenkrug has spent the time since trying to figure out how to do it in a matter of hours.

Last year, Recombinetics, the 35-person company he founded in 2008 with three other geneticists from the University of Minnesota, introduced its first genetically edited farm animal, a hornless Holstein milk cow. One of the company’s subsidiaries will bring in an estimated $3 million in revenue this year selling research labs a kind of pig capable of carrying human diseases. But its primary aim remains to supply gene-edited livestock to the agriculture industry, and Recombinetics says it can start doing that if, and about as soon as, the U.S. Food and Drug Administration approves. “We have several ­multimillion-dollar deals in the final steps of negotiations, down to the dots and titles,” Fahrenkrug says.

The FDA remains a big if. Before the agency approved the first genetically modified animal for human consumption in 2015, a fast-growing species of Atlantic salmon, biotech company AquaBounty Technologies had to spend $80 million over close to two decades, eventually selling itself to biotech giant Intrexon to keep operating. And the odyssey isn’t over: The FDA is developing more complex labeling requirements for the fish at the order of Congress. Senator Lisa Murkowski (R-Alaska), who represents a great many salmon fishers, introduced the legislative rider.

In an effort to avoid similar obstacles, Fahrenkrug and his team argue that their techniques are relatively organic. AquaBounty’s fish are genetically tweaked to have characteristics unseen in nature, the thinking goes, meaning it was unclear what effects they might have on the food chain. By contrast, Recombinetics made its milk cows by combining DNA from existing hornless cattle with that of a traditional Holstein. “This same outcome could be achieved by breeding in the farmyard,” says Tammy Lee Stanoch, the company’s chief executive officer. “This is precision breeding.”

Why hornless? To make them more space-­efficient and less potentially dangerous to handlers, most milk cows are dehorned when they’re young, in a notoriously expensive, laborious, and gut-wrenchingly cruel process that usually involves cutting tools, extreme heat, or poisonous chemicals. By genetic modification standards, a cow that eliminates those problems seems likely to find industry and activist support. Indeed, PETA has already voiced approval for hornless Holstein breeding through conventional means.

Just before Christmas, Recombinetics tried to speed its way past the FDA minders by applying for its Holsteins to be deemed “generally recognized as safe,” or GRAS. That is to say, because the cows’ genome is virtually identical to that of cows whose meat we’ve been eating for centuries, it should get waved on through.

Nope. The FDA told the company it’d be subject to forthcoming regulations, issued in the final 48 hours of the Obama administration, that lumped in all DNA-altered animals with AquaBounty’s salmon as a “new animal drug” rather than a breeding process, subjecting them to much longer evaluation processes. The primary concern remains testing the animals’ effects on the natural world on as wide a scale as possible, says Paul Johnston, head of the Greenpeace Research Laboratories at the University of Exeter in the U.K. “The broad principles have to be the same. You adopt a precautionary approach,” he says. Although the genetic editing used by Recombinetics is far more precise than other methods, Johnston says the company could still create deformed cows or more subtle metabolic problems.

Recombinetics says it’s clear those sorts of things aren’t going to happen. “We know exactly where the gene should go, and we put it in its exact location,” Stanoch says. “We have all the scientific data that proves that there are no off-target effects, and we presented that to the FDA.” Since January the company has been lobbying the agency to modify its proposed regulations and telling other Trump administration officials that its cows’ DNA is so familiar that the creatures shouldn’t fall within the FDA’s purview at all. Agriculture Secretary Sonny Perdue is reviewing agency regulations with the goal of eliminating any overlap; Recombinetics hopes to benefit.

Perdue’s office declined to comment. Alison Van Eenennaam, a geneticist at the University of California at Davis who’s grown some of Fahrenkrug’s hornless Holsteins in her research facilities, worries that treating the animals like drugs could render them impractical, forcing Recombinetics to constantly play catch-up to get the latest generation of cows approved.

A long list of desirable genetic tweaks is in the pipeline, Fahrenkrug says. There’s a mutation in bony tropical cattle that confers heat resistance, which he’s introducing into fatter North American breeds; one that stops male pigs from going through puberty, so farmers don’t have to castrate them; and others that confer resistance to the flu and other diseases, lessening the need to blow through Earth’s known antibiotics. And, of course, he found a mutation inspired by that big-bottomed sheep. “We know when the first mutation happened that caused this beautiful butt,” he says. “The sheep’s name was Solid Gold. We’ve now copied that into the identical location in goats,” Africa’s second-most-­important food source.

Recombinetics isn’t just waiting for a firmer answer from regulators at home. It’s conducting tests in Australia, Brazil, and New Zealand and says it expects approval for its cows in at least one of those countries in the next two years. “These animals are coming,” says Stanoch. “It’s a matter of whether the U.S. government wants to be in the lead on this or if they want to be fast followers.”

    BOTTOM LINE - Recombinetics says its genetically edited animals are ready for market, but it has to convince the FDA at a time when regulations on genetic modifications remain in flux.
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