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New push to deregulate 'gene-edited' animals

Piggybacking on President Trump’s government-wide deregulation effort, the biotech industry is lobbying for the removal of restrictions on creating pigs without tails and cattle without horns through gene editing.

They insist the new process is not a big deal, since cattle horns can be eliminated through cross-breeding. Gene editing, which tweaks an organism’s DNA without introducing other species, merely makes the process much faster.

They want the Trump administration, according to a report in Technology Review, to move the responsibility for oversight of gene editing from the Food and Drug Administration – which now puts gene-edited animals in the same classification as new drugs – to the Department of Agriculture.

The latter agency likely would have a far more tolerant view, the report said, having “already decided that gene-edited plants (unlike transgenic ones) can be planted and sold in an unregulated fashion.”

The meat industry simply wants the same consideration.

The Review report said the problem is that the FDA “says it regulates such edits to animals’ DNA as if they were drugs and will demand substantial safety tests.”

One company fighting for the change, 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.

Recombinetics uses gene editing to create farm animals with useful properties, eliminating negative properties.

The process works with an organism’s own DNA but doesn’t bring in any from another species. The company has made black-and-white Holstein dairy cattle with no horns, for example.

Proponents argue that many of the rules and regulations on the issue were made decades ago, when there were no technologies for genetics.

“Companies say they want each animal judged on its inherent risk – not how it was made,” the report says. “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.”

Days before Barack Obama left office, Nature.com reported, his administration turned back the deregulation effort.

At the time, the FDA said all animals whose genomes have been intentionally altered must be examined for safety like new drugs.

Alison van Eenennaam, an animal geneticist at the University of California-Davis, called the requirement “insane.”

Proponents point out a project by a Massachusetts company that spent $60 million to develop fish – an Atlantic salmon with added genes from Chinook salmon to allow it to grow faster – had to wait 20 years for the FDA to consider risks.

Even after that, the salmon still could not be sold because of the FDA’s indecision over whether it must be labeled as modified.

At that time, Scott Fahrenkrug of Recombinetics said his company would market food without FDA oversight, since the USDA announced to would not bother regulating a mushroom that had been genetically modified because it did not use genes from other species.

According to this week’s Technology Review report, there’s little likelihood Congress would act on the issue, which is why Recombinetics hopes the Trump administration will take oversight of the animals away from the FDA.

“Under Trump, this is the one flickering chance of getting it changed,” Cassis Edgar, a lawyer at McKee, Voorhees & Sease who works on animal biotech, told the publication.

The White House hasn’t announced any changes yet, the report explained, 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.'”

The Review noted 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 U.S. 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.”