FDA Approves Frankenfish – What Could Possibly Go Wrong ….?

On December 21st, the Food and Drug Administration announced that the first genetically animal animal ever approaching approval for public consumption – a hybrid Chinook Salmon-Pouty – has been declared to have “no significant impact” on the environment.  As of the 21st, the FDA’s tentative approval of this GMO salmon, called “Frankenfish” by its many detractors, entered a 60-day public comment period.

In Alaska, home of a high percentage of the world’s remaining wild salmon, and a state where fish farming has been banned since 1989, the state’s three national legislators quickly responded to the FDA decision.  Most colorful, Republican Representative Don Young quipped:

“You keep those damn fish out of my waters. It will ruin what I think is one of the finest products in the world,” (Congressman Don) Young said in an interview, saying he fears that the spread of fish farms could eventually contaminate the wild salmon industry in Alaska. He wants to force delays in any FDA approval.

“If I can keep this up long enough, I can break that company,” he said, referring to AquaBounty, “and I admit that’s what I’m trying to do.”

Republican U.S. Senator Lisa Murkowski put out a press release and video:

Kenai River angler Sen. Lisa Murkowski, R-Alaska, was railing against ”Frankenfish” again on Friday after the U.S. Food and Drug Administration gave a green flag to long-running efforts to produce bigger, faster-growing, genetically modified salmon. Murkowski, backed by Alaska fishing organizations, has repeatedly tried to stop such approval by tying the agency up in red tape.

She previously tried, but failed, to get the Senate to require the National Oceanic and Atmospheric Administration (NOAA) be intimately involved in the process. She said again and again she thought a more thorough scientific review of the biotechnology was in order. But she sort of let slip on Friday that the demand for better science was really more of a smokescreen for efforts to simply kill the idea.

In a video released by her office outlining her renewed opposition, she stated flatly, “I just don’t believe that these fish should be approved.”

And Alaska’s junior Senator, Democrat Mark Begich denounced the FDA plan:

“The notion that consuming Frankenfish is safe for the public and our oceans is a joke,” Sen. Mark Begich, D-Alaska, said in a statement Friday. “I will fight tooth and nail with my Alaska colleagues to make sure consumers have a clear choice when it comes to wild and sustainable versus lab-grown science projects. . . . Today’s report is by no means the final say on this issue.”

Along with concerns about what might possibly go wrong if some of these hybrids escaped into the wild and successfully bred, there are other concerns, particularly about how what is already being touted as a potentially very inexpensive food product will impact Alaska’s commercial salmon industry, along with those of other countries who harvest wild salmon.  Alaska’s wild salmon industry suffered 50% diminution in prices paid for their product when the first farmed salmon started showing up in quantity in the marketplace.  The GMO salmon, which appear to be even cheaper to produce than farmed Atlantic salmon, could do this all over again.  Economist Nicolaas Mink is concerned about this:

The health of wild salmon rests, however counterintuitive it may seem, on the global desire to consume wild salmon. Right now, wild salmon command consumer allegiance when it is priced somewhere between 30 and 80 percent more than its farmed counterpart.  But when wild salmon becomes two and three times more expensive than this new, faster growing genetically modified salmon, a growing number of price-sensitive consumers will think twice.

The market for wild salmon will collapse in the global rearrangement that comes with the introduction of this fish, and with it the political and economic will to maintain the ecological health of wild salmon stocks in Alaska.

This is the crucial point that the FDA report misses, and it is the one that will have the most significant ecological consequences when AquaBounty releases this fish to the public.

One of the strangest aspects of the December 21st FDA announcement on tentative approval of frankenfish, was that it came now, rather than many months ago.  Just a couple of days before the FDA’s declaration, Slate published an article critical of the lapse between the completion of the draft report and its release:

The bioengineered salmon has been winding its way through a labyrinthine approval process for 17 years. And it’s been in regulatory purgatory for more than two years since the Food and Drug Administration held public hearings—and promised a final determination within weeks.

As recently as last week, a spokeswoman for the Food and Drug Administration told me, “The application is still under review.” But that’s not the whole story.

The Genetic Literacy Project (GLP), which I direct, has learned that in April, the FDA completed its draft environmental assessment (EA), the final step in its scientific evaluation. The agency confirmed that the salmon is safe to eat and poses no serious environmental hazards. The approval document had made its way through every appropriate agency in an interagency review process coordinated by the Office of Science and Technology Policy (OSTP), which oversees the president’s science policies and is empowered to enforce integrity guidelines.

But within days of the expected public release of the EA this spring, the application was frozen. The delay, sources within the government say, came after meetings with the White House, which was debating the political implications of approving the GM salmon, a move likely to infuriate a portion of its base.

The GLP has been leaked a confidential copy of the 159-page assessment, dated April 19, 2012, which had been circulated and approved—a summary of which we have been given permission to publish. It states that the Center for Veterinary Medicine, which has regulatory responsibility within the FDA, reached a “no effect” determination under the Endangered Species Act. That should have led to the publication of the EA in the Federal Register, paving the way for a public review period, which would have lasted 30 to 90 days. If the process had been followed, genetically modified salmon could have been on dinner tables by next year.

When asked about the holdup, FDA spokeswoman Siobhan DeLancey said, “I recommend you talk to the OMB or the White House. That’s all I’m willing to say.”

So, with the election over, and the controversial topic of GMO approval in California, for instance, killed, it appears the Obama administration decided to move forward on getting this weird new product to market.

Jon Entine’s long Slate article on the Byzantine aspects of FDA’s reluctance to move forward on this, though written from a viewpoint favorable to the new product and GMO food in general, is quite thorough, and worth a read.

However, nowhere in Entine’s article is there mention of any plans to rear the fish anywhere but in labs on Canada’s Prince Edward Island, and in rearing and growth pens in the mountains of Panama:

Anticipating environmental concerns, AquaBounty [the GMO salmon's designer] developed the salmon at a secure indoor facility in Prince Edward Island, Canada. A second facility was established in the mountains of Panama to evaluate whether the fish perform well under standard commercial conditions.

As part of its evaluation, the FDA inspected both facilities, determining the fish would be securely contained with multiple redundant systems that would prevent the salmon from escaping into the wild—one of the main concerns for people opposed to GMOs. The FDA concluded that even a catastrophic event at the Panamanian facility would not pose a threat. Lengthy expanses of warm, muddy water outside the facility would serve as a graveyard to any escaped cold-water fish. If some somehow made it to the ocean, they would die in the warm currents thousands of miles from their spawning grounds in the frigid waters of the North Atlantic.

Yet, on December 22nd, the New York Times noted the plans of an ex-employee of AquaBounty [emphasis added]:

AquaBounty has argued that the faster growth of its fish makes it feasible to rear them in inland tanks rather than ocean pens, reducing the environmental impact. “That allows us not to disturb the oceans whatsoever,” said Elliot Entis, the founder of AquaBounty.

Mr. Entis, who no longer works for the company, has formed a new company to rear the salmon in the United States.

What could possibly go wrong here?