Big interview: Ronald Stotish, ceo, AquaBounty Technologies

‘Political shenanigans’ must not thwart scientific review process, warns GM fish boss

By Elaine Watson

- Last updated on GMT

Related tags Atlantic salmon Salmon Food and drug administration

FDA: Transgenic salmon would have "no effects on stocks of wild Atlantic salmon"
FDA: Transgenic salmon would have "no effects on stocks of wild Atlantic salmon"
Arguments put forward by senators attempting to derail the approval process for the world’s first genetically engineered fish for human consumption are politically motivated and have no basis in fact, according to the firm trying to bring them to market.

AquaBounty Technologies’ AquAdvantage Atlantic salmon includes a gene from the faster-growing Pacific Chinook salmon, which enables it to reach maturity twice as quickly as standard Atlantic salmon and consume less feed.

The reduced production costs meant the fish could be reared inland in tanks in the US, reducing transport costs and carbon emissions, said the firm’s chief executive Ronald Stotish.

The transgenic fish were biologically and chemically indistinguishable from standard Atlantic salmon, but simply grew faster, claimed Stotish, who was speaking to after a group of senators and congressmen wrote to the Food and Drug Administration (FDA) calling it to cease the approval process.

“The physical size of the end fish is just the same. This really is a very precise technology and a remarkably simple change. It just makes them grow faster.”

Claims flatly contradicted by the evidence

Letters to FDA commissioner Margaret Hamburg – signed by eight senators and 15 members of the House of Representatives - cite “a variety of ​[unspecified] concerns from potential threats to public health and the environment to the socio-economic impacts on producers of sustainable wild salmon”.

A press release​ by one signatory - senator Mark Begich - warns the fish could "decimate wild salmon populations​" and adds: "We don’t need Frankenfish threatening our fish populations and the coastal communities that rely on them.”

But these claims were flatly contradicted by evidence made public by the FDA after a meeting of its Veterinary Medicine Advisory Committee last year, insisted Stotish, who was “pulling my hair out​” waiting for the FDA to make a final decision.

As the politicians in question were well aware, he said, the transgenic salmon were sterile, exclusively-female, and unable to breed even if they did escape from enclosed, FDA-regulated facilities into the wild.

“The data is out there – although it has been ignored by all of the opposition groups – the FDA has already concluded that there is no food safety or environmental risk. But a science-based review process is being threatened by political shenanigans.” ​(Click here​ to read the FDA’s conclusions.)

The economics of salmon production

He added: “Some ​[critics] just have an issue with the technology, but others have been quite candid that their concern is about the price of Alaskan salmon. An economic argument is one thing, but to masquerade your ​[economically-motivated] opposition as a food safety or environmental issue is at best disingenuous but arguably much worse.”

If approved, he claimed, the AquAdvantage salmon would compete with farm-raised Atlantic salmon, which was imported from all over the world. Alaskan wild salmon meanwhile, was competing in a different market, and would continue to command a premium price.

“We have got a location in Panama that can rear the fish – which we set up in order to test the technology – but the plan is that we would act as a hatchery to supply the eggs to producers that would grow the fish. There are appropriate locations all over the US and we’ve had a lot of interest.”

Time consuming and unpredictable regulatory process

The next stage in the approval process is the publication by the FDA of an Environmental Assessment (based on its review of the company’s own EA document), followed by a period for public comment.

But it was anybody’s guess when this would happen, he said. “I wish I had a clear answer, but in some respects the timeline seems to be driven by concerns about liability​ [USDA and the EPA had faced legal challenges in relation to some GM crop approvals on “procedural​” National Environmental Policy Act issues, he said].”

It was something of a miracle that investors kept the faith in many biotech firms considering how time-consuming and unpredictable the regulatory approval process was, added Stotish. “Should we fail in the US of course we will try ​[to gain regulatory approval in] other regions, but we wanted to start in America. We are an American company.”

FDA: No effects on wild salmon stocks

In its analysis ​of the AquaBounty technology published last September, the FDA said: "The food from AquAdvantage Salmon that is the subject of this application is as safe as food from conventional Atlantic salmon.​.. In addition, no effects on stocks of wild Atlantic salmon are expected.”

In a Q&A document ​about the fish on its website, it also answers a question about whether its animal drug approval process is appropriate for GM fish.

It responds: “Yes. The review of the AquAdvantage Salmon, conducted under that process, includes a rigorous analysis of food safety and application of a stringent safety standard: reasonable certainty of no harm.”

As regards allergenicity, it says: “People who are allergic to Atlantic salmon will likely be allergic to AquAdvantage Salmon because it is a finfish (one of the eight most allergenic foods in the US), not because it has been genetically engineered.”

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Reply to Henry

Posted by Jennifer Christiano,

Dear Henry,

Just to be clear, I did read the article, as well as several previously printed articles on this subject. I have also pored through many, many papers on the production and approval of transgenic organisms since the early 1990's. I am a former research scientist with BA and MA degrees both from The University of Chicago. I have worked in and around animal research labs and spent a number of years at the bench in human clinical research labs, so I do have some insight into how science is conducted. Like making sausage, the process is not always pretty, and certainly not always ethical.

During the mid 90's, I wrote a small number of articles on the potential problems with GE foods and the lack of proper science in the approval process. They were created for, and printed in, the Hyde Park food co-op newspaper. Those articles were based on a number of then-current research studies on the process of producing GE organisms, as well as on actual agricultural experiments, all printed in peer-reviewed science journals I culled from the Regenstein and several other campus libraries. I documented every article that I used, often pointing out the absurdly and shockingly poor controls used in the experiments, and the wildly optimistic conclusions reached.

The GE fish debate is only one of the latest controversies in the long and frighteningly sloppy history of transgenic research. Time and time again, according to actual studies published and accepted as sound science in both industry and non-industry, referreed journals, researchers have set up trials that are so obviously questionable that one can only ponder how any respectable organization can possibly put them forth as true research, if there were not some form of political or financial motive? I see that other astute readers have picked up on questions that should be screamingly obvious to AquaBounty or the scientists who conducted the studies. For example, by what mechanism(s) is(are) the rapid growth traits expressed - and how will the biochemical means by which these traits find expression, affect consuming organisms? Other, less obvious questions come to mind, such as, do the transgenes affect salmon gut flora, and if so, how will the flora interact with other organisms they come into contact with when they are released into the water or soil (as when pens are cleaned and waste is disposed of)? (Think about gene transmission through the environment courtey of natural plasmids, and you will realize that this is not an idle question.) Another issue - are the by-products commonly used for making pet foods and farm animal feed, safe for pets and farm animals to consume? Also, will the oils be purified and sold as supplements, and if so, will they have the same lipid profile and health benefits as wild oils? And finally, what about genes or gene fragments that are transferred into the environment through sea birds or other animals who may "poach" and consume fish from the tanks, or fragments of flesh from dead fish disposed of outside of a hermetically-sealed dump?

These questions are just tips of icebergs. Have they all been studied? If not, why not? What I have posed are just a few ways in which problems can develop. When a problem rears it's ugly head somewhere down the road (and it will, just as Roundup Ready canola is becoming a nightmare for farmers), who will take responsibility, and put forth the money and manpower to clean up the messes?

Considering the wrath that a society can generate when it finds out that it's been force-fed (literally) a highly toxic bill of goods, AquaBounty might count itself lucky if its "product" is not approved. But of course, with all of the profit which will have been generated, the owners might figure that by then they'll be able to simply laugh themselves all the way to the bank - in China.

P.S. - Like the others who ave written comments here, I have no financial or political stake in any of this. I don't even eat fish. I simply have a desire to see that this beautiful, unique and fragile planet continue to be a haven for the miracle of life in an otherwise vast, cold universe. Tell me, when the "oops" factors have multiplied out of control and taken over (as did the brooms in The Sorcerer's Apprentice), how much good will AquaBounty's money do for any of us on a biologically collapsing Earth?

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Multiple agenda and amateur science

Posted by Steve Esposito,

Reading on the various attempts to commercialize genetically modified foods, it is astonishing time and again how convinced the sponsors of those projects try to pass amateur science projects as hard proof.
For instance: what does it mean exactly the fish "simply grows faster"? It would be important to know if that is achieved by increased growth hormones that the end customer would eat. If the science is serious there should be an answer and if there is an answer why isn't it communicated what the effects on the human body (especially in children) are? Putting 1 and 1 together the conclusion can only be, the effects are either not studied or unfit for publication (meaning nobody would by that fish). So the other agenda of the industry is to block exhaustive labelling on the product so the customer simply doesn't have the chance to make an informed choice.
P.S. Very amusing also how "low CO2 emissions" are used as an argument to improve the image of a product.

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Not so sure

Posted by Jon Yaffe,

Having read the FDA review of the ABT transgenic salmon, a few things stand out:
1. The FDA did no original research, but rather reviewed research designed and conducted by the company with a financial stake in the marketing of the product.
2. The number of subjects (i.e., fish) in the various study groups was amazingly small - as few as six in each group. Small numbers of subjects makes for broad variability statistically, which masks differences between study groups. That notwithstanding, there were numerous instances of the transgenic fish having statistically different properties (e.g., higher levels of certain hormones, and higher frequency of abnormal body parts. The study concluded these abnormalities would not have problematic impact on consumers, and thus discounted them. The researches did not deem it worth reconsidering the starting assumption that transgenic fish are no different than normal fish of the same variety.
3. Studies of the health effects on consumers were based on comparisons of analytical profiles of tissue composition, rather than being based on actually feeding the fish to live subjects - especially young developing subjects (since the nature of the transgenic treatment was to increase the fishes' output of growth hormone). The failure to include such studies is a massive oversight. The analytics performed, even if done with the greatest of integrity (which may or may not be the case with studies performed by those with vested interests in a certain outcome, only looks at those substances predicted to be problematic. It does not allow for the discovery of the unforeseen.
4. On deep reflection, it seems positively strange that the company would not have conducted studies involving feeding their fish to various animal populations. If not, why not? If so, why were none of these studies offered to (or reviewed by) the FDA? Or am I missing something?
The FDA review was a substantial document, and perhaps I missed that portion of the discussion.
What I can say without qualification is that transgenic products make me very nervous, and I do not accept the premise that they are equivalent to seemingly similar organisms developed through conventional breeding. If transgenic fish are commercialized, it is absolutely vital that they be labeled and identifiable to consumers as transgenic.

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