Frankensalmon and the FDA

by MARTHA ROSENBERG

Rockville, MD

The FDA says it has not decided about approving AquAdvantage Salmon yet, even though it held hearings about how to label the genetically engineered fish the day after hearings about if it should be approved.

But a lot of invited speakers didn’t get the memo.

Presenting to the Veterinary Medicine Advisory Committee (VMAC) last week, Yonathan Zohar, from the Center of Marine Biotechnology at the University of Maryland, extolled the "promise" of aquaculture and bashed Greenpeace and other groups who are against growing "fish in cages."

And, Alison Van Eenennaam, with the Department of Animal Science at University of California-Davis, declared during labeling hearings, that GE salmon "poses no additional risk," criticized the New York Times’ AquAdvantage Salmon coverage and laughed at peanut allergy labels. She also served on the veterinary committee advising the FDA, the previous day.

The AquAdvantage Salmon was created by inserting the coding sequence from a chinook salmon growth hormone gene, under control of an ocean pout gene, into wild Atlantic salmon. The resulting fish grows twice as fast as wild Atlantic salmon, reaching its full size in 18 months instead of three years.

Though the fish, all female, are 95 to 99 percent sterile, Boston-based AquaBounty Technologies’ (ABT), its developer, says eggs will be grown on Prince Edward Island in Canada and adults in Panama because the respective marine environments discourage survival of escapees.

The FDA has approved GE crops, genetically modified bovine growth hormone (BGH) used in milk and, last year, a goat with human genes to create a blood clotting drug. But the AquAdvantage Salmon is the first GE animal whose flesh will actually be eaten.

Because the AquAdvantage Salmon is affected by a "transformation event" and the injected DNA "imparts traits" to the animal, the salmon’s application is actually being treated as a "new animal drug approval," hence a vet committee.

Some say the public health orientation of the new top two at FDA, Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein (who spoke twice) will spell a harsher climate for genetically engineered foods. The public is also becoming less GE friendly and rejected BGH in milk in 2006, 13 years after it received FDA approval.

But FDA staffers who spoke at the hearings read right out of AquaBounty Technologies’ playbook, creating distinctions between "risk," "hazard" and "harm" — ice is only a risk if you slip on it they pointed out — that made the fish appear safer.

FDA staffers also said the AquAdvantage Salmon had minimal impact on the "human environment" until the advisory committee asked as opposed to what other kind of environment whereupon the term was dropped.

FDA’s Eric Silberhorn itemized ABT’s redundant safety systems to prevent the escape of GE salmon — screens, floor drains, chemical containment, chlorine, nets — as written in the sponsor’s Environmental Assessment, prepared for the FDA, bringing to mind BP.

Why does the government present industry data on behalf of industry, some in the audience asked, and why is industry called the "sponsor" instead of "applicant"?

AquAdvantage Salmon were also said to be less "fit" if they escape though no one quoted the part of ABT’s Environmental Assessment report that says the salmon eat five times as much as wild salmon and have less fear of predators. (see: Jurassic Park)

The risk of bootleg AquAdvantage Salmon surfacing in unregulated Asian operations, even returning as imports like a "transgenic shrimp" Silberhorn says is reported in US food, would be handled with the labeling, control and inspection given any US drug, said staffers. Of course other nations, like Canada and Panama are "sovereign" and not bound by our laws, added FDA’s Larisa Rudenko.

Genetic Unknowns, Layers of Carcasses

While the FDA did not use the loaded terms drift and mutate (or Frankenfish) it did request a "durability" report from ABT to make sure nothing genetically untoward happens.

And its Center for Veterinary Medicine briefing report finds an unexpected and unwanted genetic "rearrangement" with the AquAdvantage Salmon which relocates the inserted genetic material from "the far upstream promoter regions" to a "downstream location relative to the growth hormone coding region." Oops. The loss of part of a "35 base repeat region" and possible duplication of another effect were also reported.

Asked by the committee if the genetic unknowns could create unanticipated events, Jeff Jones, a veterinarian presenter at the hearings, said the changes were "not subject to the hormone feedback system" in the fish and that the relocated genetic construct currently abuts "something that can’t be read."

Elsewhere in its report, the FDA finds low glucose levels and high incidences of jaw erosion, focal inflammation and insulin-like growth factor 1 (IGF-1) in the AquAdvantage Salmon but concludes, giving no evidence, they are not caused by the genetic engineering.

While the FDA report says ABT’s excessive culling of "abnormal" salmon may have "skewed" safety studies, it does not question ABT’s proposed method of disposing of salmon affected by the 3Ms, mutations, morbidity and mortality.

"As dead fish are deposited, they will be covered with caustic lime, followed by another layer of dead fish and caustic lime, etc., until the burial pit is ~0.5 m deep, at which point it will sealed with plastic and covered with soil," says ABT’s Environmental Assessment. "In the event that disposal capacity at the site is inadequate to handle the immediate or aggregate waste volume, alternative means of disposal will be sought."

Antibiotics, veterinary drugs and coded antibiotic resistance were barely mentioned at the hearings (though Zohar predicted egg farm like densities of up "80 to 100 per cubic meter for the GE salmon) — nor was the practice of harvesting wild fish to feed farmed fish (though one invited speaker actually promoted the practice.)

In fact there was only one meltdown in the FDA’s otherwise confident presentation and it concerned ABT’s allergy study whose, "technical flaws… so limit its interpretation that we can not rely on its results," says the FDA report.

When FDA food scientists Kathleen Jones and Kevin Greenlees presented the allergy research, which sought to establish safety levels with no number that would be unsafe, the advisory committee pounced.

"It’s as if you selected an allergen in goat meat and one in sheep meat and compare the two and found a difference," said Louisiana State University’s David F. Senior, who chaired the committee. "Who cares?"

"These studies are a bust," said another committee member, asking why they were not conducted again.

"I am not a statistician and she is not here today," retreated Jones, adding that the studies were absolutely "above board," though no one had suggested they weren’t.

"You’ve reached the limit of my statistical" knowledge said Larisa Rudenko.

And when James D. McKean with the Department of Veterinary Diagnostic and Production Animal Medicine at Iowa State University asked why one table showed a category of comparison salmon suddenly dropped as a lone, extra salmon seemed to appear out of nowhere, skewing the results, FDA’s Greenlees said, "It’s my fault" and "I apologize."

Many hope an apology for considering an approval of the AquAdvantage Salmon itself is forthcoming.

MARTHA ROSENBERG can be reached at: martharosenberg@sbcglobal.net

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