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The Sloppy Science "Proving" Frankenfish Are Safe

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Try this recipe for your next dinner party: Begin with eggs from a genetically engineered (GE) female Atlantic salmon with DNA from both Chinook salmon and Ocean Pout (an eel-like fish). Add irradiated sperm from an Arctic Char (a different fish species), mix, and put under pressure to produce a generation of all-female GE salmon with two sets of chromosomes from their mother and none from the Arctic Char. Then add 17-methyltestosterone to turn the GE salmon females into "neomales" -- genetically female fish that produce milt (sperm). Combine their milt with the eggs of non-GE Atlantic salmon females, place under pressure, and -- voila! -- you've got a batch of all-female, triploid (having three complete sets of chromosomes instead of two) GE Atlantic salmon. Yum! Smoke that up and put it on your bagel.

Doesn't sound appealing? Well, that describes the new GE salmon AquaBounty Technologies seeks to commercialize as the AquAdvantage salmon -- the first genetically engineered animal to directly enter the U.S. food supply. They claim it grows to market size in 16 to 18 months instead of the usual 30. And, just before Labor Day, the FDA ruled that it is safe.

Despite the obvious gross-out factor of the "neomales," the truly important thing to focus on is the quality of AquaBounty's science ensuring us that their GE salmon are safe. They tested the fish for physical and behavioral problems, hormone levels, several chemistry and hematology components, and allergenicity to humans. Unfortunately, the science behind many of these tests was so sloppy that it's hard to determine from them whether the GE fish are safe or not.

For example, in many tests, they used sample sizes as low as six (far less than the 30 one would need to establish statistical significance). In other cases, they disregarded the most unfavorable results as "outliers" and instead focused on only the data that made the GE fish look as good as possible and simultaneously made the non-GE control group of fish look as bad as possible. And then there's the test of 73 fish for hormone levels, in which none of the fish had levels of growth hormone above the detection limit. In that case, AquaBounty concluded that there was no detectable difference in growth hormone levels in its GE fish compared to the non-GE controls.

It's not terribly shocking that a corporation would fudge its own safety data to try and convince government regulators that it was safe (BP, anyone?). But it's wholly unacceptable that the FDA accepted the sloppy and misleading science behind the GE salmon to rule on its safety. Now the FDA is gearing up for a series of meetings September 19-21 for the next step in the GE salmon approval process.

The significance of this issue extends far beyond the GE salmon. This is the first time the FDA has given its regulatory process for GE animals a test drive. The case of AquAdvantage salmon will set a precedent, for better or for worse. It's certainly possible that, despite the shoddy science used to "prove" the safety of GE salmon, that people will be able to eat GE salmon without any problems. But what happens when we allow the next GE animal to go to market without solid science proving its safety? And then next? And the next? We need to start insisting on solid science now, sending a signal to all biotech companies that sloppy science is not enough.

You can see the actual data behind the FDA's determination that AquAdvantage GE salmon are safe here (or you can check out a longer piece I wrote on it based on an interview with Michael Hansen, Senior Scientist at Consumers' Union, here) -- and you can tell the FDA that we need better science before we allow a precedent-setting GE animal into our food supply here.

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