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To: Neil Hoffman, Chief Scientific Advisor in the Office of the Deputy Administrator in Biotechnology Regulatory Services

Tammy Lee Stanock, president & CEO of Recombinetics, a company that breeds gene-edited animals, recently wrote an opinion piece for The Hill, “Regulatory restructure of biotech is critical to the future of US agriculture.” Stanock argues for ending Food & Drug Administration oversight of genetically modified animals in favor of “putting the USDA exclusively in charge of regulating all food animals.” 

The advantage for Recombinetics is obvious. Whereas, the FDA uses its regulations for animal drugs to review the safety of genetically modified food animals, the USDA has no process whatsoever for evaluating the safety of animals created through novel technologies.

Gene editing is too risky to deregulate.

The only way to adequately review the safety of a CRISPR event is to sequence the whole genome of a gene edited animal and compare it with a non-edited control. 

This is what the FDA should require of companies like Recombinetics—before their products enter the food supply.

Thank you.

Recombinetics, Inc., the Monsanto of the genetically modified animal industry, wants to be able to introduce GMO pigs into the U.S. food supply, without having to go through any regulatory process or safety testing.

And the St. Paul, Minn.-based biotech company has come up with a plan it hopes will allow it to do just that.

TAKE ACTION: Tell the U.S. Department of Agriculture (USDA): Genetically modified animals need to be thoroughly safety tested by the FDA!

Please fill out the form on this page to sign our petition, then, share this tweet.

Ever heard of a chimera? In Greek mythology, it was a fire-breathing she-monster with a lion's head, a goat's body and a serpent's tail.

In the age of modern biotechnology, a chimera is an animal with the cells of two different types of organisms.

The chimera envisioned by Recombinetics is a pig that is used as an “oincubator” to grow human body parts for transplant.

Recombinetics is also working to create animals that are better suited to the perils of life in factory farms, like pigs that won’t get porcine reproductive and respiratory syndrome (PRRS). Or pigs that don’t have to be castrated or have their tails cut off. Recombinetics also sees a future where cattle are genetically engineered to be heat-tolerant and have increased muscle mass.

So far, the U.S. Food & Drug Administration (FDA) hasn’t given any of Recombinetics’ products a pass. The agency refused to grant Recombinetics’ request for “generally recognized as safe” (GRAS) status for its hornless cows.

Instead, in the final days of the Obama Administration, the FDA said it would regulate all “animals with intentionally altered genomic DNA” as animal drugs, just as it had regulated AquAdvantage GMO salmon.

Recombinetics went ballistic. Scott Fahrenkrug, chief scientific officer, said that the FDA had “gone off the rails.”

The company went on the offense. Recombinetics hired factory farm lobbyist (and organic hater) Steve Kopperud of SLK Strategies to see if it could cash in on the Trump administration’s quest to deregulate everything in sight.

Recombinetics began by getting 79 members of the House of Representatives to write a letter to U.S. Department of Agriculture (USDA) Secretary Sonny Perdue opposing the FDA’s guidance on regulating any animal intentionally altered using gene-editing techniques as a "new animal drug."

Pretty soon, the USDA had scrapped new Obama Administration rules that would have expanded regulation of gene-edited plants. Trump told the American Farm Bureau Federation, “We are streamlining regulations that have blocked cutting-edge biotechnology, setting free our farmers to innovate, thrive and to grow.”

Most recently, Perdue announced that he had no plans to regulate gene-edited plants “that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests.”

Then, the House Agriculture Committee held a hearing where legislators made the case for transferring control of gene-edited animals from the FDA to the USDA. At the hearing, Perdue told lawmakers that the USDA would “love to have that responsibility.”

Recombinetics would, too—because the USDA doesn’t have any kind of regulatory process that it could use to review gene-edited food animals.

If Recombinetics’ plan succeeds in ending FDA review of GMO animals, this would be the most drastic deregulation of biotechnology to date.

TAKE ACTION: Tell the USDA: Genetically modified animals need to be thoroughly safety tested by the FDA! 


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