Some day soon, you might tuck into a plate of salmon without knowing that the fish you are eating was genetically engineered. The so-called AquAdvantage salmon [3], a salmon genetically engineered [4] to grow faster than normal salmon, just moved one step closer to legalization. If so, it will be the first genetically engineered (GE) animal allowed for consumption in the United States. Thus, every part of the regulatory process related to the GE salmon [5] sets a precedent for all future GE animals in the United States -- and so far, according to experts, that precedent is a sloppy, inadequate one.

What Is AquAdvantage Salmon?

To create the GE salmon, the Boston-based public company AquaBounty Technologies [6] inserted DNA from another salmon species and an eel-like fish into the genome of an Atlantic salmon. The new genes make the GE salmon produce growth hormone all year round instead of just for three months a year as they normally would. This helps them grow to market size in 16 to 18 months instead of the usual 30 months required for an Atlantic salmon.

To prevent any GE salmon from escaping into the wild, surviving, and reproducing there, AquaBounty will only produce female GE salmon, each with three sets of DNA instead of the normal two. Triploids, as organisms with three sets of DNA are called, are infertile. Therefore, producing only female, triploid GE fish should provide two mechanisms of preventing reproduction should any fish escape into the wild. (Obviously, it takes a bit of scientific tinkering to create an all-female triploid fish population and the process used to do this [7] might make your stomach turn.)

AquaBounty will produce salmon eggs in Prince Edward Island, Canada. Then it will transport them to an inland facility in Panama, where it will grow the fish, harvest, and process them. The firm claims no live fish will ever enter the United States.

How Are GE Animals Regulated?

The next question one might ask is how the federal government goes about deciding whether or not a GE animal should be allowed in our food supply. Under a 1980s decision, written by anti-regulation ideologues in the Reagan and Bush I era before any GE foods -- plants or animals -- were ready for commercialization, the government decided that no new laws were needed to regulate GE plants or animals. This decision is called "the Coordinated Framework for the Regulation of Biotechnology [8]," or the Coordinated Framework for short.

Whereas the European Union debated the regulation of GE foods and drafted new laws [9] to address issues such as safety, traceability, allergenicity and environmental impacts, the U.S. never passed any new laws specific to GE animals or had the kind of public debate passing a new law would require. Instead, they decided to regulate GE animals as "animal drugs," using laws that are not well-suited to the unique, complex issues posed by GE animals. Specifically, the government considers the extra DNA added to the GE animals as the "animal drug." New Animal Drugs are regulated by the Food and Drug Administration [10], and they receive input from the Veterinary Medicine Advisory Committee (VMAC) -- a committee mostly made up of veterinarians, not genetic engineering experts. [11]

When a new animal drug is approved, it is only approved for production in a specific facility. Therefore, if you invent a new pill for cats, you submit data on its production in a specific facility, and you receive approval to produce it only in that facility. If you decide to build eight more factories because your drug is so popular, you must go back to the FDA to receive approval for the eight new facilities.

2010: Sloppy Science on Trial

Back in 2010, the FDA took the first steps to approve AquaBounty's application to produce the GE salmon. It released a draft Environmental Assessment (EA) and several hundred pages of safety testing data from experiments performed by AquaBounty on the GE salmon. Then it gave the public a mere two weeks to comment on the data, and it convened VMAC to advise it on the GE salmon.

For watchdog groups, this was the first signal that something was, well, fishy. Consumers Union senior scientist Michael Hansen excoriated the safety data [12] as "sloppy," "misleading," and "woefully inadequate." In addition to using small sample sizes and culling deformed fish and thus skewing the data, AquaBounty only provided data gathered in its Prince Edward Island facility, where it will produce GE salmon eggs. But, by law, it must also provide data from its Panama facility, where it will grow the salmon to full size.

The VMAC committee didn't give a resounding approval either. The New York Times [13] summarized their findings, saying, "While a genetically engineered salmon is almost certainly safe to eat, the government should pursue a more rigorous analysis of the fish's possible health effects and environmental impact." However, the committee only advises the FDA, and its decisions are not binding.

2012: FDA Readies Its Rubber Stamp

Following the VMAC meeting and a second, public meeting on labeling issues surrounding the GE salmon, the FDA went silent. Over the next two years, it quietly examined the public comments and the input from the VMAC committee. But despite VMAC's suggestion for a more rigorous analysis, the FDA moved the application one step closer to approval without really addressing the gaping holes in the AquaBounty's science. In May of 2012, it produced an ever-so-slightly improved Environmental Assessment (EA) compared to the original draft it made public in 2010, and a preliminary "Finding of No Significant Impact" (FONSI).

The preliminary FONSI and draft EA were not made public until they were published in the Federal Register on December 26, 2012. At that point, the FDA began a 60-day period in which the public could review its findings and submit comments.

What happened between 2010 and 2012 to improve our confidence that the GE salmon is safe for human consumption and for the environment? Nothing. There's no new data whatsoever. The only changes are a few minor additions to the EA -- certainly not enough to inspire confidence that the government heard the critiques made in 2010 and addressed them.

After a group of Senators led by Mark Begich [14] (D-AK) sent the FDA a letter [15] asking for a 60-day extension to the comment period, the FDA agreed to take comments until April 26, 2013.

What's Fishy About the GE Salmon?

"There are still unanswered safety and nutritional questions and the quality of the data that was submitted to the FDA was the worst stuff I've ever seen submitted for a GMO. There's stuff there that couldn't make it through a high school science class," reflected Hansen in early 2013, after reviewing the newly released documents.

Almost laughing, Hansen remarks on the obvious flaws in AquaBounty's scientific justification of the fish's safety, saying, "That's not science, that's a joke!" Becoming more serious, he adds, "There's allergenicity questions and other health questions. It shouldn't be approved. They don't have any data to show that it's safe."

"There are environmental issues as well," Hansen continues. "Not so much in Panama, but on Prince Edward Island. That's where they're going to producing eggs. Guess what, to produce eggs, you've gotta have fertile adults." Before the wild Atlantic salmon population was decimated, the waters around Prince Edward Island was salmon habitat. An escaped GE fish could easily thrive there. "Yet," adds Hansen, "they conclude that even if they get out the water's too cold!"

In an interview with Flash in the Pan, environmental risk scientist Anne Kapuscinski also criticized the FDA's process. Back in the 1990s, she authored the reports on how to perform environmental risk assessment. But, by 2007, her 1990s publications were so out of date that she led a team of scientists to write an updated book on the subject. Despite the updated scientific methods, the FDA opted to use the old, outdated methods from the 1990s to conduct its environmental risk assessment on the GE salmon.

The 2007 publication was rigorously peer reviewed by reviewers from around the world. Yet, the FDA ignored it. Kapuscinski calls their methods unscientific, adding that if the FDA were a student who submitted this report for a grade, it would fail. "Students would get into serious trouble if they were citing really old methods, and there had been huge advances in the methods since then and they ignored that. That would be a reason to fail them."

She submitted comments back in 2010, but says, "it looks like either they didn't read our comments or they just decided to ignore them." She points out that the Panama facility that AquaBounty will use to grow the fish out of is not large enough for a commercial venture. "It's at a scale to show proof of concept of the commercial viability of this," she said. "Once the company scales up to selling millions and millions of eggs, the fish will be farmed by producers with all kinds of facilities." Those facilities might not be as well protected as the one in Panama. Unless the FDA brings its risk assessment methods up to date, we have no adequate, scientific assurance that GE salmon won't escape into the wild.

Next Steps

Despite the scientific questions, there's no sign that the FDA will overturn its preliminary decision to allow commercialization of the GE salmon. The best Michael Hansen is hoping for at this point is a requirement that the GE salmon -- one legalized -- will be labeled as genetically engineered. He calls this "an outside chance."

Unfortunately, as Hansen notes, "This is to set a precedent. If they let the GE salmon go through, why would any other company that wants to get a genetically engineered animal through bother" producing rigorous, scientifically valid data to prove its product's safety?

If you don't want to see GE salmon in your local supermarket in as little as a few years, you can take action. The FDA is accepting public comments until April 26, 2013. You can write your own message and submit it at Regulations.gov [16] or you can join Food and Water Watch's campaign against the GE salmon here [17]. You can also write your representatives to let them know your point of view.