FDA Decision Will Lead To First Ever Genetically-Modified Animal For Consumption

The Food and Drug Administration has completed its highly-anticipated evaluation of the environmental impact of the world’s first genetically-engineered (GE) fish for human consumption, and written a document supportive of its commercialization on the U.S. market, according to a person close to the review process.

The evaluation is now under review at the White House’s Office of Management and Budget.

Meg Reilly, a communications liaison for the White House, confirmed the office now has the final documents under active review, but declined further comment.The final release of the report is likely to spark off further controversy over the fish since many environmental groups, as well as several members of congress, oppose the farming and sale of such fish. They are worried about their impact on the environment, on other species, and on the existing fishing industry.

As many as 16 applications for transgenic fish may be under review throughout the world, mostly in Asia, although none are known to be yet approved, according to congressional testimony from the Veterinary Medicine Advisory Committee of the FDA.

Massachusetts-based AquaBounty Technologies, Inc. has engineered and bred more than ten generations of AquAdvantage, a super-fast growing GE salmon.

The photograph above shows an AquAdvantage salmon in the background contrasted against a regular Atlantic salmon sibling of the same age.

The FDA this spring completed a finalized version of an environmental assessment report on the fish, and the document made its rounds through inter-agency review, clearing the way for a final decision on its commercialization. The final environmental assessment has so far been undisclosed to the public.

The fish eggs would be produced on Prince Edward Island in Canada, licensed and purchased from grower clients, and raised as sterile fish in double-barricaded, land-based aquaculture systems designed to prevent their escape into the wild, and ensure their genetic isolation.

Polarizing Debates

The so-called “AquAdvantage” fish engenders polarizing debates on the reorganization of nature and the extent to which biotechnology should be relied upon to bolster our shrinking natural resources: A third of worldwide fish stocks are overfished or near extinction, while consumption doubled from 1973 to 1997, says the International Food Policy Research Institute.

In 2006, the world consumed 110.4 million metric tons of fish. Just under half of that was produced by aquaculture. The Food Agriculture Organization of the United Nations estimates an additional 28.8 metric tons will be needed to add to production by 2030.

Economists call such dwindling resources in the context of rising demand a Tragedy of the Commons. Scientists and entrepreneurs are now creating GE fish for land-locked aquaculture, and open-ocean farming technologies to usher in a Blue Revolution of the seas, on par with the Green Revolution of agriculture that occurred in the U.S. between the 1940s and late 1970s.

It’s not happening without anti-GMO detractors, fishing industry opponents and legislative opposition.

In a largely symbolic gesture, the House voted in June to restrict funding for work on the report at the FDA, and several senators with fishing industry constituents authored a letter this July to the FDA asking it to abandon work on the approval process. The Senate has since taken no action.

The FDA previously issued a report saying that the fish is safe for human consumption. Eighteen months ago, it issued a more than 100-page environmental assessment report, the third and last of three important documents, and opened it up to public comment for roughly a month. The FDA then released a finalized version of that report, and this past summer it completed inter-agency review.

“The U.S. FDA has extensively studied this fish and has declared it exactly the same as any other Atlantic salmon. There is no difference between the flesh of this fish and that of Atlantic salmon consumed every day,” said Ronald L. Stotish, AquaBounty Technologies’ CEO and president.

AquaBounty generated a construct that includes a “gene cassette” from the Pacific Chinook salmon that it can splice into the Atlantic salmon to give it the instructions to grow big. The construct is called opAFP-GHc2 and it contains two units, one of which is a gene that encodes a protein called a growth factor hormone.

The construct also contains a stretch of DNA from the promoter region of an ocean pout, an eel-like creature that lives in extremely cold environments (the promoter is a switch that controls the expression of a downstream gene).

Normally, the eel uses this promoter to keep an antifreeze gene turned on constantly so it does not freeze. The promoter is therefore “constitutive,” meaning it is always active, and coupling it with a growth factor gene in an Atlantic salmon results in the salmon experiencing a continual growth spurt–since the growth factor is continually produced.

Studies have shown that the genetically-altered Atlantic salmon’s appetite would make it constantly ravenous, meaning that it would eat everything around in sight.

In its first year, AquaBounty Technologies’ AquAdvantage Atlantic salmon has a two-to-six-fold increase in size–the largest being 13 times bigger than the average natural Atlantic salmon–and it reaches full maturity in half the time.

Concerns over the quality of the FDA’s review AquaBounty Technologies

The FDA in 2009 classified genetically modified traits in animals as veterinary drugs, and some criticized this decision, as it allows companies to shield details of their product from the public as proprietary information.

The FDA declined to comment on the status of the AquaBounty’s application, and releases no information on the number of applications it has been getting for GE animals in general, drawing persistent complaints from activist groups such as the Center for Food Safety, Greenpeace, and Food and Water Watch.

Colin O’Neil, a regulatory policy analyst for the non-profit Center for Food Safety, a group that has organized counter-lawsuits against GE crop engineer Monsanto, is leading a campaign to stop the fish from coming to market. He says safety studies that evaluated the allergenic properties of the fish used too small a sample size — six GE fish and six controls.

“Frankly, that’s not a pool sufficient to determine if the fish poses allergic harm; if that’s the rigorous criteria the FDA is using, we have numerous concerns,” he said in an interview with TPM’s Idea Lab.

O’Neil says a concern is that the fish could escape and mix with wild fish populations, even though AquaBounty’s CEO Ronald Stotish has said that the risk of that is infinitesimal.

The argument against the transgenic salmon is that if it were to escape into the wild, a founder population might homogenize the population–a term called Loss of Heterozygosity–and reduce biodiversity. Biodiversity translates to immune system diversity and is critical for protecting species against parasites, microbes and viruses.

AquaBounty’s fish are required to be kept in double-barrier, land-locked systems to ensure their genetic isolation. The National Oceanic and Atmospheric Administration says that since 1990 more than a million farmed-raised salmon have slipped the barriers of farms into Puget Sound and its tributaries.

But farm-raised salmon in the wild are like domesticated puppies in a backcountry of wolves–of the million fish NOAA says escaped few were ever found — apparently gobbled up by predators, or too docile and ill-equipped to survive the open ocean.

Further to that point, Suzanne Turner, a spokesperson for AquaBounty, emphasized that her company’s application was specific to land-based systems, while an entirely new application process would need to be taken on to farm the fish in net pens. The company says it or its clients have no intention to pursue net pen farming of transgenic fish.

The company has taken measures to make sure that its AquAdvantage fish are sterile, slipping the transgenic fish an extra chromosome. It works in 98 percent of cases, and the company claims that, in combination with its land-based system, it can achieve genetic isolation of the fish. Still, the US Department of Agriculture awarded AquaBounty $494,000 to further study improved fish sterilization techniques, increasing the public funds the company has received to more that $3 million.

O’Neill said the grant “depreciated any confidence the scientific community had in this company,” although Turner demurred, countering that O’Neill’s activist group is openly anti-GMO, and that her company’s technology has been under development for 20 years, and under review for 16 years, and that it the FDA documents have so far found no major issues with the companies techniques.

Anne Kapuscinski, professor of sustainability science at Dartmouth College, has been among many skeptics of the commercialization of transgenic fish. She says that it would be difficult to make a reliable profit raising salmon in land-based aquaculture facilities that impose huge energy demands.

In the U.S., 93 percent of soybeans and 86 percent of corn is genetically modified with a transgene, and there is little question that genomics is now advancing fast into animal frontiers.

Scientists have proven accomplishments in improving the growth rates of carp and tilapia. China has developed a cow that produces human breast milk. An “Enviropig” was designed to generate eco-friendly manure, A spider silk gene has been installed into a goat such that it can spit out many copies of its protein through breast milk — but scientists have not figured out how to recreate the tensile strength of silk the way a spider does.

There’s no question that there are more of these kinds of biotechnology innovations in the pipeline. However, the public in the United States won’t have a chance to weigh in on the question of whether they want the “products” entering their society because of the FDA’s opaque approval process, say critics.

While the United States Department of Agriculture reveals applications that are filed, the FDA does not, so it is difficult to know how many companies are producing transgenic animals, and how quickly similar products could come to market if the FDA establishes a precedent.

“As of now, we don’t know what is being submitted for approval,” said Center for Food Safety’s O’Neil.