Farmland gene editors want cows without horns, pigs without tails, and business without regulations

The lobbying effort to get the FDA out of the way of biotech animals is under way.


By Antonio Regalado, MIT Technology Review

March 12, 2018


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.


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