White House Involved in FDA Approval of Genetically Engineered Salmon?

A couple of days ago, Talking Points Memo’s Jim Kozubek reported that the Food and Drug Administration had finally decided to approve AquaBounty’s genetically engineered salmon for human consumption, and that the “evaluation is now under review at the White House’s Office of Management and Budget.” I’d seen the TPM article, but didn’t write about it at the time because premature reports of FDA being on the brink of approval have been filtering out through the media for several years now. (I filmed a TV interview for Fox News’s “Your World With Neil Cavuto” way back in 2005, when it looked like an approval was right around the corner, for example. And I talked about it again on John Stossel’s show last year.) But a friend of mine asked today why an FDA approval decision would have to get a second look from the White House, so I thought that would be worth discussing.

As the TPM article mentions, the AquaBounty salmon has been hugely controversial. Wild Atlantic salmon grow to full adult size in about three years, in part because they only grow six or seven months per year. As water temperatures decline in the late autumn months, a genetic switch turns turns off the gene that produces growth hormone, so the salmon can conserve energy through the winter. Energy conservation isn’t as big a problem for farmed fish, though, because they have easy access to food all year and little exposure to predators. So, AquaBounty engineered Atlantic salmon with a promoter (the genetic switch) from an Arctic fish called the ocean pout, attached to the growth hormone gene from Pacific Chinook salmon. And, voila! The engineered salmon grows year round and reaches normal adult size in about 18 months, lowering the cost of raising them and lowering the price of fish in grocery stores. Here’s the packet of scientific information FDA prepared for its scientific advisory committee last year.

Environmentalists don’t like it, of course. In part because ocean pen-raised farmed fish are known to occasionally escape into the wild, meaning the AquaBounty salmon could theoretically interbreed with wild salmon, with potential impacts on the wild gene pool. And in part because they just don’t like biotechnology. To address the arguably legitimate concerns, the AquaBounty salmon will only be raised in contained, inland pools, not open water pens, and they”ll be farmed only in Panama, where, if they do escape, the ambient water temperatures will be too high for them to survive. AquaBounty also uses two other breeding techniques that, with a 98 percent degree of certainty, produces only female fish that have been rendered infertile. So, even if they were to escape and survive, nearly all of them would be incapable of successfully mating with wild fish. Also, because the AquaBounty fish will be searching for food during the early spring months when wild Atlantic salmon are breeding, it turns out that the engineered fish have an extraordinarily low mating instinct. (Insert ribald, ex-wife joke here.)

Pacific salmon fishermen don’t like the AquaBounty fish because farmed salmon are the competition, and anything that makes the competition more efficient makes them less competitive. That’s why a group of Republican and Democratic congressmen are supporting a bill that would forbid the FDA to approve it.

Which brings us back to the OMB review. My friend asked, “What’s up with that? Does OMB usually get to sign off on FDA approval decisions? Or is this a special case, since the fish are genetically engineered?”

Ordinarily, OMB has authority to review proposed new regulations and guidance documents issued by executive branch agencies, not individual approval decisions — whether they’re biotech product approvals, drug approvals, pesticide approvals, broadcast spectrum license approvals, or any other individualized decisions. However, because the FDA Commissioner is appointed by the president, she technically works for the President of the United States. Commissioner Margaret Hamburg may well just be cooperating with the White House on the AquaBounty salmon approval, knowing that it will be controversial. So, one possibility is that FDA is just having the OMB staff (possibly, a division of OMB called the Office of Information and Regulatory Affairs) have a look at the decision documents in order to ensure that all the political bases are covered.

Another possibility is that FDA may be issuing a new regulation or guidance document in conjunction with the approval, and that would need OIRA clearance. FDA decided during the George W. Bush Administration to regulate the novel trait in genetically engineered animals as New Veterinary Drugs (a stupid decision, but that’s a story for another day). In January 2009, FDA issued a guidance document explaining its legal authority to do that, and laying out the steps through which animal breeders would seek NVD approval. Ordinarily, I would have expected that to be done through a rulemaking procedure, rather than through guidance. So, it’s possible that the proposed rule has now been drafted and that OIRA review is necessary to clear that proposed rule for promulgation.

These possibilities are pure speculation on my part, and I haven’t ruled out the possibility that TPM just got the story wrong. After all, as I wrote above, we’ve been hearing stories for the past six years about FDA being on the brink of approval. It’s long past time that FDA approve it, though. The application has been at FDA for 16 years. The science is pretty clear that the product is safe for both consumers and the environment. And there’s good reason to believe that it would convey substantial health benefits for consumers by lowering the price of a food product that is highly nutritious, not to mention good for the environment by taking pressure off wild fish stocks that are often over-harvested. Why the White House might stand in the way of an approval decision is beyond me.