‘Frankenfish’ May Soon Be Spawning: Is Genetically Modified Salmon Safe?

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I haven’t decided what to think about the controversial “Frankenfish,” the genetically modified salmon whose maker, Massachusetts-based AquaBounty Technologies, is seeking Food and Drug Administration (FDA) approval — and seems positioned to get it. Starting Sunday, Sept. 19, an FDA advisory panel will convene a two-day public hearing on the matter. (More on Time.com: 6 Genetically Modified Foods That Changed the World)

The panel will hear from AquaBounty and from FDA scientists who reviewed the company’s application for approval and announced earlier this month that the altered salmon, called AquAdvantage, is safe for human consumption and poses no threat to the environment. (You can read a PDF of the 172-page background discussion of the research.)

That boosts the odds of approval, and if the FDA does allow AquAdvantage to reach market, it would be the first genetically modified animal approved for human consumption. It would also pave the way for other engineered animals to enter the U.S. food source. (See the Enviropig.) That’s given some onlookers a big case of the willies.

But with our unsustainable appetite for the pink-fleshed fish depleting the world’s fisheries at alarming rates, can we really afford to be so squeamish?

Over the course of the two-day meeting, the advisory panel — which will ultimately advise the FDA’s top officials on whether to approve the new fish — will also hear from the public, likely including environmental groups, consumer groups and independent scientists who are concerned about the decision. (More on Time.com: The ‘Other’ Salt: 5 Foods Rich in Potassium)

In a separate meeting to take place on Sept. 21, public discussion will center around another contentious topic: labeling. Although the public increasingly wants to know how food is produced, the FDA says it cannot legally require labeling on genetically modified salmon if the agency has decided it is not materially different from conventional salmon — which it has.

If AquAdvantage is cleared for market, Americans may find that labeling occurs by omission: that is, companies that produce natural salmon may post “No GMO” on their products as a marketing strategy, once the altered fish hits stores.

But as the Washington Post notes today: “the FDA has maintained a tough stance for food makers who don’t use genetically engineered ingredients and want to promote their products as an alternative. The agency allows manufacturers to label their products as not genetically engineered as long as those labels are accurate and do not imply that the products are therefore more healthful.” More from the Post:

The agency warned the dairy industry in 1994 that it could not use “Hormone Free” labeling on milk from cows that are not given engineered hormones, because all milk contains some hormones.

It has sent a flurry of enforcement letters to food makers, including B&G Foods, which was told it could not use the phrase “GMO-free” on its Polaner All Fruit strawberry spread label because GMO refers to genetically modified organisms and strawberries are produce, not organisms.

It told the maker of Spectrum Canola Oil that it could not use a label that included a red circle with a line through it and the words “GMO,” saying the symbol suggested that there was something wrong with genetically engineered food.

The AquAdvantage salmon is an Atlantic salmon that contains a growth hormone gene from the Chinook, a much larger (and endangered) Pacific species of salmon, plus an “antifreeze” gene promoter from the ocean pout, the salmon’s distant relative.

The result is a salmon that grows at twice the rate of farmed Atlantic salmon. The pout’s antifreeze gene allows AquAdvantage to make growth hormone in winter — normally, salmon do not produce the hormone in cold weather — which enables it to reach market size in 18 months instead of three years.

FDA scientists have analyzed the data and found the engineered fish to be nutritionally and biologically identical to conventionally grown salmon. (More on Time.com: Experts Split on Safety of Diet Drug Meridia)

Still, groups like the Union of Concerned Scientists and the Consumers Union are voicing concerns over the agency’s process of research review, pointing to the fact that the data included statistically insignificant sample sizes of fish (as few as six fish in some comparative tests) and to the practice of culling deformed genetically modified salmon before testing.

Among other concerns:

1. The FDA report found that genetically altered salmon had higher levels of tissue inflammation than natural fish, suggesting more fragile immune systems. This could force salmon farmers who use AquAdvantage to increase antibiotics in feed, already a problem with regular farmed salmon. This, in turn, may contribute to the prevalence of antibiotic-resistant bacteria that are a threat to our own health.

2. Altered salmon contain higher levels of insulin like growth factor (IGF-1), a growth hormone, than conventional fish. According to AquaBounty’s own report, its salmon has a 35% higher IGF-1 count than natural controls.

The question is whether this level of hormone from food animals has any bearing on human health. AquaBounty and FDA scientists found that based on an estimate of maximum daily salmon intake that is significantly higher than what Americans typically eat, exposure to IGF1 in altered salmon would still be below levels that could cause concern. But independent scientists have argued that it is impossible to know the health impact of AquAdvantage because humans have not yet consumed it.

3. The FDA scientists’ recent stamp of approval for AquAdvantage seems contrary to the agency’s previous position. In a 2007 FDA paper entitled GM Food Animals Coming, the agency argued against the approval of genetically modified salmon, stating:

Fish genes are most frequently used in producing transgenic fish, but it would be a mistake to regard the transgenic fish “substantially equivalent” to the native fish, as even the Codex consultation document acknowledges that, “transgenic expression of non-native proteins in plants may lead to structural variants possessing altered immunogenicity.”

4. The FDA is allowing only a 14-day period of public review of AquAdvantage research before its approval decision — too short a time for independent scientists to analyze the available data, critics say. (More on Time.com: New Fat Fighting Machines: Real, FDA Approved)

For its part, AquaBounty says health concerns over genetically altered fish are politically motivated and inaccurate. “The FDA has done a very conservative assessment and their conclusions, independent of the company, have been that [AquAdvantage] is safe for human consumption,” says Dr. Ron Stotish, a biochemist and CEO of AquaBounty. (It’s important to note that the FDA does not conduct independent research — it assessed research conducted by AquaBounty.)

“This is the most studied fish ever. The FDA spent 15 years creating a framework with which to evaluate transgenic animals,” adds Suzanne Turner, a public outreach officer at AquaBounty, which has been seeking FDA approval since 1995.

Of greater concern than any potential health consequence of consuming AquAdvantage is the likelier environmental impact of growing it. If the fish were to escape into the wild, scientists have speculated that the altered fish could negatively impact survival rates of wild salmon.

A recent Discovery News article reports:

All species of wild Atlantic salmon are listed as endangered. Adding any type of new threat could throw them over the edge. Often, [Jeff] Hutchings, [a fish biologist at Dalhousie University in Halifax, Canada], added, genes that are inserted for one purpose have other unintended and unpredictable effects.

“It’s fairly difficult to make precise predictions about what would happen if interbreeding took place between GMO and wild salmon,” Hutchings said. “But almost certainly the consequences would not be positive for the wild salmon, particularly given their poor conservation status.”

As part of an expert panel in 2001, Hutchings and colleagues recommended that, if approved, GM fish should be raised only in land-based facilities, not in aquatic pens that are prone to frequent escapes. The scientists also suggested a procedure that sterilizes eggs, which would prevent fish from passing on their genes, even if they did get into the wild.

Indeed, according to its maker, AquAdvantage is intended to be raised only in land-based tanks to minimize the chances of escape. AquaBounty reports that it will raise only female salmon that are triploid (have three sets of chromosomes, instead of two), which renders them sterile. Think mule: the donkey-horse hybrid is also triploid and famously cannot breed.

Also from Discovery News:

“The chances of some negative evolutionary consequence from the approval or use of GM salmon is pretty low, if not negligible,” Hutchings said, at least in comparison to the effects of other human activities. Some studies, for example, suggest that fishing pressure has changed the size and age at which some fish first reproduce.

Several major scientific panels, Hutchings added, have found no sign that GM salmon would harm human health in any way. Tissue for tissue, he said, GM salmon and wild salmon are indistinguishable.

If approved, the fish could help ease demand on the woefully overfished populations of Atlantic and Pacific salmon. The U.S. Fish and Wildlife Service lists several species of Atlantic and Pacific salmon as threatened or endangered, and more than 70% of the world’s fisheries are at risk of total collapse, according to Greenpeace.

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