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HOTH was delighted to see the USDA’s announcement this week that they are taking a commonsense, pro-farmer approach to regulating gene editing in plants.   Pork producers are very excited about the potential offered by gene editing, and—at least for those who also grow crops—this means that precisely edited plants like corn and soybeans will soon be available that will be hardier, more disease resistant, and more sustainable.

The USDA’s approach—which can be viewed here – is notable for several reasons.  First, the USDA has acknowledged the real need to make development of genetically edited crops affordable, timely, and accessible to smaller producers.  Their approach will ensure that this technology can be broadly researched, developed, and implemented at a pace that will maintain U.S. global leadership.  Second, it exempts gene edits that could otherwise be achieved through selective breeding.  It allows developers of these edits to make this determination based on sound genetic information.  The USDA approach means that we are poised for a revolution in crop production that will pay huge dividends to farmers, consumers, and the environment.

HOTH’s happiness is tempered, however, by the FDA’s refusal to take the same approach when it comes to gene editing in animals.  The FDA—based on a decades old administrative decision—has laid regulatory claim to gene editing in all animals and has proposed a draconian approach to regulating this crucial new tool.  In a nutshell, they have decided that all edits should be treated the same as old-school genetic modifications that incorporated foreign DNA into animals.  What’s more, the resultant animals will be regulated as animal drugs (the FDA will claim that it’s the animal’s genome that’s the drug, not the animal—HOTH sees absolutely no functional difference) and farms may even be regulated as drug manufacturing facilities.

The FDA’s proposed pathway has already had a chilling effect on research into gene editing in livestock.  At least one major university is ready to scrap their program because they see no viable future under FDA regulation.  HOTH has even heard that the USDA itself is reluctant to engage in research on gene editing in livestock.  Meanwhile, other countries are surging ahead with innovative, pro-science regulatory pathways for gene edited livestock.  The U.S. is lagging all our major competitors here in the Western Hemisphere—and at a real danger of ceding our elite animal breeding industry to Canada, Brazil or Argentina.

It’s time for the U.S. to get on the same page with gene editing in plants and animals.  If the FDA can’t get it right, we need to move all authority—for both plants and livestock—to the USDA.  We desperately need a common, pro-science approach that allows for rapid adoption of simple gene edits that could otherwise be achieved through selective breeding* with risk-based regulatory oversight.  HOTH does acknowledge that there are differences between plants and animals (though from the perspective of genetics not as fundamental as the FDA seems to think).  We think this difference can be simply accommodated—don’t outright exempt animal edits and let a regulatory body, not the developer, make the determination that the edit corresponds to a change that could be made through conventional animal breeding.  Otherwise, from a risk or any other perspective there is no reason to regulate plants differently than animals.

Time is running out for the U.S. to get this right.  If we want our research institutions to maintain leadership on developing this exciting new technology, our farmers to have access to it to produce healthier, more sustainable plant AND animal products, and consumers to reap the benefits of things such as improved food safety and reduced antibiotic usage we need to act now.  HOTH urges the Administration to give the USDA a much larger role in gene editing in animals, and for our friends on the Hill to lend their support to regulatory reform.  We simply cannot afford to be left behind while the rest of the world charges forward.


*While some of us at HOTH spend a lot of time thinking about animal breeding, we realize that most people don’t.  It’s reasonable to question why we need gene editing if we can just get the same result through traditional animal breeding.  The crucial reason is with gene editing you can just get the one trait that you want, not all the other genetic differences.  Pardon us for using the dog as an example, but people are more familiar with the different breeds of dogs than they are of pigs.  All the different dog breeds are of the same species and can freely interbreed, despite their extremely different appearances.  Let’s say that someone finds a Chihuahua that has a gene that makes it resistant to heartworm.  Problem solved in Chihuahuas, but what about Great Danes that have a different, non-resistant copy of that gene?  You can cross a Chihuahua with a Great Dane, but in addition to the obvious logistical challenges you would end up with an animal that may or may not have inherited the resistance but would have inherited a lot of other traits—it certainly wouldn’t look like a Great Dane!  You would then have to spend years and years crossing back to the Great Dane to try and keep the resistance gene but get rid of all the other Chihuahua traits.  You might eventually come close with luck.  The same thing holds true with livestock—there may be a very desirable version of a gene you want to swap between breeds, but the damage to productivity would be too severe for anyone to try and make that happen through crossbreeding.  This is why gene editing is so exciting—it truly is precision animal breeding.