The home page of the Minnesota biotech company Recombinetics shouts “The Gene Editing Revolution Is Here.”
Or it would be, if only those pesky regulators would get out of the way.
The company is using gene editing, a new kind of precise molecular scissors, to create farm animals with useful properties. Gene editing, unlike its controversial cousin, transgenic modification, tweaks an organism’s DNA but doesn’t introduce any from other species.
Recombinetics and its partners have already used gene editing to make black-and-white Holstein dairy cattle with no horns and male pigs that never reach sexual maturity, avoiding the “boar taint” that can make pork chops unpleasant.
The problem is that right now, the US Food and Drug Administration says it regulates such edits to animals’ DNA as if they were drugs and will demand substantial safety tests. Recombinetics says that makes no sense; hornless cattle made with gene editing, it argues, are identical to what you could get by crossbreeding dairy cows with naturally hornless cattle.
Now MIT Technology Review has learned that industry officials are trying to get the administration of President Donald Trump to solve their problem at a stroke by shifting responsibility for the animals from the FDA to the US Department of Agriculture. That agency has already decided that gene-edited plants (unlike transgenic ones) can be planted and sold in an unregulated fashion. The biotech firms want their tweaked cows and pigs to get the same treatment.
Arguably, they have a point. If you can sell gene-edited soybeans that haven’t had to go through a battery of safety tests, why not gene-edited beef?
The reason you can’t is that US food regulation is a web of anachronistic distinctions. The USDA, created explicitly to spread improvements through the agriculture industry, inspects most meat, raw (but not processed) fruits and vegetables, and processed (but not raw) eggs. The FDA, part of the Department of Health and Human Services, supervises fish (except catfish), venison, and genetically modified animals—the current bone of contention. To implement regulations, the agencies often rely on decades-old laws whose authors never imagined genetic search-and-replace technology.
Strangely, even 40 years into the biotech age, there still no consensus on what a better regulatory system would like. BIO, a trade group in Washington, DC, is commissioning a white paper to look at the issue, say people who have been briefed on the plans.
Companies say they want each animal judged on its inherent risk—not how it was made. Regulate “the product, not the process” goes the industry refrain. Specifically, they don’t believe genetic manipulation of animals should automatically trigger safety regulations, as it does now.
Again, they have a point. Some dairy cattle naturally don’t have horns, and you’d have difficulty telling them apart from Recombinetics’s genetically tailored animals—of which there are as yet only a handful, living at a research facility.
Recombinetics has been pushing to ease the rules on gene editing for a while. In 2016, it petitioned the FDA to consider its hornless animals as GRAS—that is, made up of known ingredients “generally recognized as safe,” like salt, calcium, or DNA itself. Since its edited cattle contain only slightly revised cattle genes, the company argued, there is “no scientific or other logical reason” to impose special safety regulations.
The FDA decided otherwise, however. Two days before President Barack Obama left office, the agency said it planned to treat edits made to animals as new drugs. To the agency, genetic tinkering is “intended to affect the structure [or] function” of an animal. Therefore, gene editing, just like any veterinary drug, falls under the Food, Drug, and Cosmetic Act of 1938, the law from which that phrase comes.
Counting on Trump
To barnyard entrepreneurs, the FDA decision was “insane” and bad for business. Recombinetics hopes to create a business whereby anyone with a blue-ribbon steer could send the company some skin cells and, a year later, get a cloned copy with the no-horns gene instructions added, or with some other valuable change to its genome.
The economics don’t make sense if every designer bull needs to go through years of safety testing. The most valuable Angus ever sold cost about $800,000. That’s a fraction of what a five-year regulatory journey would cost, and most bulls are of course worth much less.
There seems to be little chance the US Congress will revise the patchwork of regulations covering biotechnology through legislation. That’s why Recombinetics, with the help of industry lobbyists, is now hoping the Trump administration will take oversight of the animals away from the FDA.
The administration has already shown its business-friendly side: it intends to repeal the Clean Power Plan, exited the Paris climate accord, and did away with net neutrality. “Under Trump, this is the one flickering chance of getting it changed. This is the one chance to make a broad impact,” says Cassie Edgar, a biotech regulatory lawyer at McKee, Voorhees & Sease who chairs a committee on animal biotechnology policy for BIO. Tammy Lee Stanoch, who became CEO of Recombinetics in August 2017, says she has “been in frequent communication with the White House.”
So far, the administration hasn’t announced any new policies on gene-edited animals. But it’s made noises that sound like music to the biotech industry’s ears. In a speech in Nashville, Tennessee, in January, Trump painted regulators as a relentless enemy of farmers and said the administration is “streamlining regulations that have blocked cutting-edge biotechnology, setting free our farmers to innovate, thrive, and grow.”
A month later, during a hearing in Congress, representatives briefed by BIO peppered USDA chief Sonny Perdue with questions about whether a regulatory handoff could happen. “We’d love to have that responsibility,” Purdue answered. (A spokesperson for the FDA said the agency was still reviewing public comments to its proposed guidelines.)
Whatever the U.S. decides to do with biotech animals will have global repercussions. That’s because beef and other farm products are traded internationally. And while consumers have had plenty to say about GM corn, as of yet they have not had to decide how they feel about GM steaks or chicken breasts. FDA has only ever approved four biotech animals, including just one that people eat, a fast-growing salmon from AquaBounty.
Some companies say the FDA’s stricter process isn’t all bad. One British firm, Genus, is seeking FDA approval for pigs with a single gene removed to make them resistant to a virus, PRRSV, that costs US swine breeders more than $1 million a day. Jonathan Lightner, Genus’s chief of R&D, says that although “it is not intuitive” why the animals should be treated as drugs, the agency’s hard-won seal of approval could actually help with “public approval and acceptance” when it’s time to start selling the hogs.
Consumer groups and those who oppose GMOs, however, say they will fight against weaker animal regulations. Jaydee Hanson, a policy analyst at the Center for Food Safety, a watchdog group, already told Recombinetics that he’s prepared to arrange for protests at dairy farms.
Indeed, while it’s hard to object to hornless dairy cows (dehorning, commonly done to prevent the cows from hurting people or each other, is a painful and bloody process), future edits might not seem so benign. One scientist at the University of California, Davis, is trying to create bulls that sire only male offspring. For its part, Recombinetics hopes it can one day make pigs without tails so these don’t have to be clipped off. (In close quarters other pigs bite them.) It's easy to anticipate public unease growing as the traits added to animals become less and less familiar.
To the industry, all of that is just another reason to regulate the animal, not the way it was made. “You have to look at it on a case-by-case basis. You can’t just say ‘gene editing,’ because then someone sticks in a scorpion toxin gene or makes all-male cattle,” says Edgar, the biotech lawyer. “It’s complicated.”
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