Genetically engineered grains are mainstream, but gene splicing in livestock remains experimental. A Boston area biotechnology firm hopes to change that and end its 18-year quest for commercial approval.

Growth rates are accelerated significantly in genetically engineered salmon, as illustrated by these siblings, the smaller of which did not receive the transgenic growth gene. Source: Aqua Bounty Technologies Inc.

Researchers Garth L. Fletcher and Choy L. Hew of Canada’s Memorial University began their transgenic fish experiments in 1982, eventually mastering microinjection of antifreeze protein genes from the ocean pout into fertilized Atlantic salmon eggs to enable caged salmon to survive the winter waters off the Newfoundland coast. Next, they mastered integration of the antifreeze protein with the growth hormone DNA of the giant Chinook, king of the salmon species. The technology was licensed to a Waltham, MA-based biotech firm, which spun off Aqua Bounty Technologies Inc. in partnership with the scientists. The transgenic salmon line was established in 1992.

Establishment of genetically engineered (GE) feedstock was the fast-track part. Developers initiated discussions with FDA in 1993 to determine an appropriate approval process. After floundering in uncharted regulatory waters, the first study to support a new animal drug application was submitted in 2001. By then, various public interest and environmental groups had mobilized in opposition. By the time the FDA’s Veterinary Medicine Advisory Committee ruled last year GE salmon was safe to eat and posed no environmental threat, the Alaska Congressional caucus and others began efforts to block approval.

Leading Aqua Bounty’s counteroffensive is Ronald L. Stotish. He joined the firm in 2006, serving as vice president for regulatory affairs, then senior vice president-R&D and president and CEO. A biochemist and molecular biologist with advanced degrees from Rutgers University and a bachelor’s degree from Penn State, Stotish describes himself as “a product of the pharmaceutical industry” and an expert in animal health.

Ronald L. Stotish, president and CEO, Aqua Bounty Technologies Inc., Waltham, MA. Source: Aqua Bounty Technologies Inc.

FE: How does GE salmon differ from wild Atlantic salmon?

Stotish: There’s nothing special about our fish. It has the exact same amino acid sequence as the Atlantic salmon’s growth hormone. Whereas conventional salmon exhibit a delayed initial growth pattern, however, this salmon grows more or less like a trout. And it should be noted that, outside a wild source in waters outside of Iceland, today’s Atlantic salmon are a cultivated species that are placed in sea cages for grow out.

By allowing the fish to produce growth hormone with the on/off switch from the ocean pout’s antifreeze gene, early growth occurs. You can’t achieve the growth rates that we achieve by simply putting the fish in warmer water. You could achieve these growth benefits with classic methods, but it would take 50 years, whereas we achieve them in one generation.

FE: With these salmon reaching market weight in half the time, would you expect them to be priced lower?

Stotish: There is the potential for lower-cost salmon, but the real benefit is that, because they grow at a more predictable and rapid rate, it allows land-based cultivation. Currently, young fish are put out to sea after years of early growth in pens. Aquaculture in a pond or tank isn’t done because three to five years are needed, and the utility costs alone would be prohibitive. These salmon would allow land-based production near consumption centers, eliminating the carbon footprint associated with transport, which is significant.

FE: What do you say to advocates of traditional fisheries?

Stotish: It’s not a myth; it’s a fact: The world wild-caught fisheries are stressed. We’re approaching 7 billion global population, and we could reach 9 billion in 20 years. Annual growth of 10 percent in aquaculture has been going on for 20 years, and the US is way behind.

A lot of technology and American innovation have gone into transgenic fish. Other nations are trying to catch up on our research, notably China, which has a huge effort in this area. At least 18 other GE livestock projects are waiting until the outcome of our petition. At the end of the day, we may still emerge as the world leaders, but there’s the real danger the US will remain importers of seafood developed with our technology.

FE: If commercial production is approved, where do you anticipate salmon aquaculture will occur?

Stotish: South Dakota is very interested in hosting grow-out operations, and there is interest throughout the Great Lakes region, particularly Ohio and Illinois. You just need a suitable supply of water to set up a facility that can produce 1,000 tons of salmon a year. In 2009, 200,000 tons of salmon were imported, so it would only take 200 facilities to make us self-sustaining.

FE: A number of veterinary doctors and scientists have become outspoken supporters of transgenic salmon, including William Muir, whose Trojan gene hypothesis is the basis of objections based on possible extinction of wild salmon populations. Has that helped allay concerns?

Stotish: Dr. Muir, a professor at Purdue University and an expert in aquaculture breeding and genetics, has pointed out that the hypothesis is not valid in respect to our salmon, yet opponents continue to raise that issue. We had hoped the approval would be a fair and respectful exchange of ideas. Unfortunately, some organizations have taken great liberty with the truth. That has been a great disappointment, but we have to take the high road.

FE: This summer, pushback came from Congress, notably from the Alaska caucus. Are they primarily protecting Chinook commercial fishing interests?

Stotish: If they had taken on the GE salmon with an economic argument, we could have engaged them. Chinook is a high-quality, seasonal fish that is very different from Atlantic salmon. It’s doubtful GE salmon would impact market prices for Chinook. Instead, the rhetoric has been inflammatory.

FE: A House amendment to the appropriations bill forbids FDA to make any expenditures reviewing GE salmon.

Stotish: Even if the amendment were passed by the Senate, which is extremely doubtful, FDA review has already been completed. The House action was an exercise in showmanship and shenanigans.

The vote occurred June 20, the day the White House hosted a barbecue for Congress. Only eight House members reconvened at the Capitol at 8 p.m. Despite the lack of a quorum, a voice vote was taken on the floor, and the amendment was passed. It does not represent a sense of the House, and 38 organizations wrote letters, condemning it as a sham. Other people also have spoken up to Congressional leaders and FDA, telling them this approval is not something to be turned into a political sham.

FE: Eight senators subsequently signed a letter to FDA, urging Commissioner Margaret Hamburg to cease the approval process. Might their effort succeed?

Stotish: The letter signers are pretty much the people who oppose technology. When challenged, they say, “I’m personally uncomfortable with transgenic livestock.” That’s fine, but that shouldn’t be the basis of regulatory policy.

FE: What’s the next step in the process?

Stotish: We’re sort of in purgatory and haven’t gotten feedback from anyone. The environmental assessment has been prepared. It must be published in the Federal Register, at which point a 90-day comment period would begin before we can proceed. Product safety and effectiveness already have been established, so it makes no sense not to publish the environmental assessment. We have provided all the requested data, everything is on the record, and unless it goes forward, the process has no credibility. Already, there’s been a chilling effect on similar new technology, and further delays would scare off potential investors. But there’s still a sense of fair play in America, and we’ve been gratified by the amount of support we have gotten.

FE: Genetically modified corn, soybeans and other seeds dominate some crops. Why has GE flora been accepted so much more easily than GE fauna?

Stotish: The review process involving USDA and EPA for plants is more clearly defined. Nonetheless, we support the FDA scientific process. The fact that it is rigorous means people will have confidence that the GE animals that get through it will be safe.

The irony is that it’s so much easier to move DNA around in animals than in plants. Whether animals, plants or medicines are created with recombinant DNA, it’s all part and parcel of the same technology.