AquaBounty
A genetically engineered salmon (top) grows twice as fast as its wild counterpart (bottom).
In the remote highlands of Panama, in tanks protected by netting, barbed wire and guard dogs, swim the world’s most expensive and scrutinized fish. These swift-growing salmon have been at the centre of a 18-year, US$60-million battle to bring the first genetically modified (GM) animal to US dinner tables — a struggle that may be nearing its end.
Last week marked the end of the public’s opportunity to weigh in on a US Food and Drug Administration (FDA) draft assessment of the salmon. Genetically engineered to grow twice as fast as their unaltered brethren, the fish pose no significant environmental threat to the United States when grown in landlocked tanks, says the FDA. The agency needs only to finalize that assessment before deciding whether to approve the fish for human consumption. The number of opportunities for a surprise delay — a recurring theme in the history of these salmon — is dwindling (see ‘Against the current’).
Against the current
AquaBounty
The US Food and Drug Administration (FDA) has been slow to approve a genetically modified (GM) salmon made by AquaBounty of Maynard, Massachusetts. The fish would be the first GM animal authorized for human consumption.
1989 Canadian researchers engineer wild Atlantic salmon to overexpress growth hormone.
1995 AquaBounty files an Investigational New Animal Drug application with the FDA.
2001 AquaBounty submits its first regulatory study to the FDA.
2009 The FDA releases guidance for its evaluation of genetically engineered animals as veterinary drugs; AquaBounty completes its FDA submission.
2010 The FDA says that GM salmon is safe to eat.
2012 The FDA completes its draft environmental assessment in May, but does not release it to the public until December.
2013 The public-comment period for the draft environmental assessment is extended by two months and concludes on 26 April.
Environmental groups are preparing to take the battle to consumers by fighting the sale of the fish in grocery stores across the country. Others point out that it will be years before the salmon are anything more than a curiosity. At full capacity, the Panama facility can produce only about 100 tonnes of salmon a year, says Gregory Jaffe, director of biotechnology at the Center for Science in the Public Interest, a consumer group in Washington DC that monitors the regulation of GM foods. That amount is a trifle compared to the roughly 230,000 tonnes of farmed Atlantic salmon that the United States imported in 2012. “You’d have to try hard to eat it,” says Jaffe. “It won’t be as hard as winning the lottery, but it will be close.”
For the firm that developed the fish, AquaBounty Technologies of Maynard, Massachusetts, those 100 tonnes are a hard-won prize. In 1989, the salmon were engineered to overexpress a growth-hormone gene. The result: ‘AquAdvantage’ fish that grew to full size in around 18 months rather than the usual 3 years. The company applied for FDA approval in 1995 and has been stuck in regulatory limbo ever since. AquaBounty has had to demonstrate the food’s safety, and gauge the environmental risk of the sterile fish escaping its tanks and successfully mating with wild salmon. By contrast, the FDA approved the first GM crop for human consumption — the Flavr Savr tomato — after just three years of regulatory consideration.
Cash crisis
The uncertainty has taken its toll. To save money, AquaBounty has reduced its staff by more than half. Last year, the company sold off its research and development arm and lost one of its biggest investors. In March, AquaBounty came within a week of running out of cash, says chief executive Ronald Stotish. The firm was saved by last-minute refinancing and fresh investment from Intrexon, a synthetic-biology company based in Blacksburg, Virginia.
At first glance, the Panama facility hardly seems to be the key to financial prosperity. With salmon selling for around $6.50 per kilogram, AquaBounty would make less than $1 million each year from the salmon. It would take decades for the company to make back its $60-million investment if it relied solely on the Panama farm.
Stotish says that the company must expand. Following FDA approval, AquaBounty hopes to sell its salmon eggs to farmers and expand to markets in Argentina, Canada, Chile and China.
To sell AquAdvantage fish in the United States, each farm would require separate FDA approval, but because the food safety of the fish has already been vetted, the approval process would require only an environmental evaluation, says Jaffe.
Yet even with regulatory approval, the battle over AquaBounty’s salmon will be far from over. In March, several speciality grocery stores, including Whole Foods, an international chain based in Austin, Texas, said that they would not sell AquAdvantage fish. Lawmakers in Alaska and Oregon, which both export wild salmon, have repeatedly tried to block the GM fish because they fear contamination of the wild stock and worry that it could drive down the price of farmed salmon.
AquaBounty’s long struggle has discouraged other US companies from producing GM animals for food. Mark Walton, chief marketing officer at Recombinetics, an animal-biotechnology company in St Paul, Minnesota, says that his company will focus initially on medical applications — using modified farm animals as disease models, for example — rather than on livestock for food. Medical applications of GM technology do not stir consumer passions in the same way as GM foods, and there is a regulatory precedent: in 2009, the FDA approved a goat that makes an anti-clotting drug in its milk. If Recombinetics invests in agricultural products, Walton adds, the items will probably be marketed outside the United States first. “The AquaBounty example has [made] the company very sceptical about how much investment to pour into the US regulatory process,” he says.
Yet Stotish says that GM animal products will inevitably find their way to grocery stores. He points to heavy investment in the technology in China, where dozens of GM farm animals are in development. “I think we will end up eating genetically modified animals of a variety of species,” says Stotish. “But they’ll come from other countries.”
- Journal name:
- Nature
- Volume:
- 497,
- Pages:
- 17–18
- Date published:
- ()
- DOI:
- doi:10.1038/497017a
The thing is NOBODY believes anything the FDA says anymore AND nobody wants to eat (or feed their children) genetically modified food or animals. There is conveniently no labeling law, so it can be stuffed down consumers throats without their knowledge. All for corporate profits. The FDA has been bought of by Monsanto, etc. and there is a revolving door of CEOs of corporations like Monsanto moving into positions in the FDA which makes it easy for them to get their poison approved, such as Aspartame. I think even a supreme court judge was once an attorney for Monsanto.
GM-Free Australia Alliance
PO Box 333,
Wonthaggi Vic 3995
Australia
To USFDA Re: [Docket No. FDA�–N�] AquaBounty Salmon April 26, 2013
Our alliance of Australian GM-free and kindred groups has a supporter base of over 30,000. GMFAA Inc is an independent not-for-profit alliance of groups sharing common concerns and motivation to avert the threats of Genetic Manipulation (GM) here. We ask you to reject the AquaBounty proposal to propagate and release GM AquAdvantage salmon into open environments and the human food supply.
The negative aspects of GM salmon that most concern us are their: health, welfare and viability – N.B. the non-viability of GM pigs, sheep, goats, cows, etc. : escape to and establishment in the wild – e.g. GM corn in Mexico; European carp, cane toads, rabbits, camels, goats; wild pigs, buffalo, etc. in Australia; and impacts on public health in the human food supply – not assured when assessed using the industry concept ‘substantial equivalence’ that cherry picks scientific evidence.
We ask you to apply the Precautionary Principle (as defined in the UN Convention on Biological Diversity) to this proposal, especially to acknowledge deficiencies in the present state of scientific knowledge and the enormity of the potential negative impacts should your best guesses and assumptions about these GM organisms be wrong.
We especially support the scientific comments, critiques and recommendations on the AquaBounty proposal made by Professor Anne Kapuscinski, Prof. of Sustainability Science at Dartmouth College, Hanover, NH and Assistant Professor Fredrik Sundström from the Department of Ecology and Genetics, Uppsala University, Uppsala, Sweden. See, for instance: http://now.dartmouth.edu/2011/12/debating-genetically-modified-salmon-npr/
Please also consider the scientific opinion prepared for the Commerce Commission of New Zealand by Prof. Jack Heinemann of the Centre for Integrated Research in Biosafety, University of Canterbury New Zealand, on the multiple impacts of GM animal feed – relevant to diets of the GM salmon proposed for release. See: http://www.comcom.govt.nz/media-releases/detail/2009/inghamswarnedovergmfreechickenclai
This is all part of the biotech food industry's mega push into our global food supply system. We have devastated our oceans and forest biodiversity, poisoned our soils and waterways with chemicals and pesticides and, instead of restoring them to health, the biotech cartel pushes on with their altering of the natural world for one thing - control and quarterly bottom lines.
More, Bigger, Faster is not nature's way and the dangers of these altered genes escaping into our natural environment are too great until we have sufficient independent peer-reviewed research showing that the human body will not adversely be impacted by ingesting these gene-changes, nor that our natural environment will be altered to a point where our ecosystem and life within them are not permanently changed. There is no mistake that the global epidemic of cancer, obesity and diabetes coincides with the release of genetically engineered foods into our environment and food supply including the processed foods that contain them. There are few regulations and little oversight to this industry - which is frightening - allowing the powerful biotech chemical cartel to force through almost anything they want. We need to tread very carefully before releasing these altered-genes and take into account the greater impact on the global biosphere. This is myopic thinking driven by the phoney "Feed The World" Campaign.
GENETICALLY ENGINEERED SALMON http://ow.ly/kHfEr
GENETICALLY ENGINEERED TREES COULD DEVASTATE FOREST ECOSYSTEMS
http://sco.lt/5G9P0L
The article says that AquaBounty has had to demonstrate the food's safety, and gauge the environmental risk of the sterile fish escaping its tanks and successfully mating with wild salmon. I do not understand if the fish is sterile how can they mate with wild salmon? An old example of GM sample is the Elephant Man Disease which is caused by Single Gene. The disease, called the Proteus syndrome, is marked by uncontrolled tissue and bone growth. It's named for the shape- shifting god from Greek mythology, and affects fewer than 500 people globally, according to the National Institutes of Health.
Exactly when did Nature drop any pretence at being a scientific journal and become a full throated advocate for industry? It appears that the author of this article is aware that there is a great deal of controversy out there about the idea of taking animals out of nature and "engineering" them. The objections to these initiatives are many and not all of them lend themselves to scientific study. Those objections that are not best approached as matters of science are not therefore trivial and unworthy and the undisguised pro-industry boosterism of this article is offensive.
Even if we confine ourselves to questions that can be answered, or at least illuminated by serious research, it would be difficult to discern actual information of this type in this article and elsewhere in Nature on this subject. We are told in the subheading that the "Slow US regulatory process highlights hurdles of getting engineered food animals to dinner tables". This is a political observation not supported even in the body of the article by actual data or serious analysis based on data. We learn elsewhere (Transgenic fish wins US regulatory backing) that "The FDA has reviewed more than 50 safety studies, including one that shows the engineered salmon poses no more of an allergic potential than a wild salmon." Now we are talking. Of the questions that science can shed some light on consumer safety is one. Sadly one reads on to find that "Anti-GE groups still have a long list of concerns. Lovera (Patty Lovera, assistant director of Food and Water Watch, a Washington DC group opposed to GE food animals) would like to see more studies done on the potential health risks of the salmon, published in peer-reviewed journals and conducted by scientists with no affiliation to AquaBounty." Furthermore "it's not clear where the money to conduct such tests would come from, as federal research funding rarely supports GE animals". So we now know that the FDA has declared transgenic fish to be safe to eat based on 50 studies by scientists linked to the industry. And the problem, according to Nature, is that there is too much regulation.
So much for disinterested science. On the economic issues, when the author is not being an outright advocate for the industry she plays the naif. "At first glance, the Panama facility hardly seems to be the key to financial prosperity. With salmon selling for around $6.50 per kilogram, AquaBounty would make less than $1 million each year from the salmon. It would take decades for the company to make back its $60-million investment if it relied solely on the Panama farm."Elsewhere she has "others" observe that "it will be years before the salmon are anything more than a curiosity". It is difficult to believe that the author of this post does not know that if only those pesky regulators could be somehow dealt with, by a science journal with credibility maybe, there is the potential for a great deal of money to be made. There are also huge environmental and safety risks that are implicit in the wholesale growth of these technologies in the marketplace and the only prudent, thorough protection we have are the regulatory process and the integrity and probity of journalism that purports to represent science. Sadly the latter is not to be found in this article.