The FDA & USDA Animal Oversight Brawl

A new memorandum of understanding (MOU) directs the FDA to hand over regulatory oversight of food animal biotechnology to the USDA – and they aren’t loosening their grip.

The MOU, signed by Ag Secretary Sonny Perdue and HHS Assistant Secretary for Health Brett Giroir, leaves the FDA with control over just gene-edited animals unrelated to agriculture.

The industry-backed move has groups such as the National Pork Producers Council cheering for faster approvals through the USDA. While managing crop biotechnology, the USDA has opened the door to dozens of genetically-engineered [GE] plant varieties while the FDA has only green-lighted two animal equivalents.

But not everyone is on board with the swap.

After the MOU was announced, FDA Commissioner Stephen Hahn took to Twitter to express his….uhm, disagreement.

Rumors are swirling about Hahn’s refusals to sign the MOU and judicial challenges are expected.

Where this goes: It’s a game of wait-and-see with the new administration and incoming USDA head Tom Vilsak, but bets are on that it’ll be a brawl.

“I think that the FDA will keep fighting USDA on this,” said Jaydee Hanson, a senior policy analyst at the Center for Food Safety.

+ Side note: In December, GalSafe pigs joined Aquabounty’s GE salmon as the second GE animal to ever be approved by the FDA. GalSafe pigs don’t contain alpha-gal sugars, allowing red-meat lovers with Alpha-Gal Syndrome to finally put a fork in pork.

FDA Stamps ‘APPROVED’ on GMO Pork

Genetically modified pigs have gotten the official thumbs up from the FDA this week.

With the approval, GalSafe pigs can now be utilized for food and medicinal purposes. The first-of-its-kind livestock alteration was brought to life by Revivicor, a regenerative medicine company.

The details: GalSafe pigs are modified to remove alpha-gal sugar from the animal’s cells. An allergy to alpha-gal sugars in humans, while rare, is believed to be caused by lone star tick bites.

As pig cells and tissues are commonly used in the medical world, there is lots of excitement. Avoiding allergic reactions to otherwise life-preserving drugs or transplants is a big deal.

The meat of the matter: The dinner plate discussion is where contention lies. Allergen studies by the FDA focused on pharmaceutical use, rather than consumption, although the department notes that the meat is safe to consume. Taste, nutritional factors, and shelf-life are identical to non-GMO pork.

But not so fast: Don’t expect to see GalSafe pork in the meat case next week. GMO labeling will have to be worked on. Plus, the meat will only be available via mail order anyway.

And even then, it’s no sure bet. Take it from AquAdvantage salmon, the only other GMO-approved consumable animal protein for humans. Five years after FDA approval, the fish filets are still not available for consumers due to continuous legal challenges.

  • Worth noting: The National Pork Producers Council has begged for the White House to move livestock genetic editing approval over to the USDA, noting the ‘FDA’s regulatory overreach’ will slow down U.S. producers’ ability to compete globally.

Bottom line: FDA approval might just be the starting line for GalSafe pigs. Time will tell if and when it becomes commercially available.