« December 2010 Table of Contents
Top Story: Super salmon?
AquAdvantage has become a lightning rod for transgenic critics
By Stuart Hirsch
December 01, 2010
Despite a barrage of criticism from consumer and
environmental advocates, the U.S. Food and Drug Administration
early next year could approve the first transgenic farm animal
designed for human consumption - a fast-growing Atlantic salmon
developed by AquaBounty Technologies.
For well over a decade, crops such as corn and soybeans have
been genetically modified using precise biotechnology methods
to deter pests, prevent disease and better
temperatures, drought and herbicides. Using that same science
with animals to achieve certain traits has taken longer to
develop - the common practice now is much slower and less
precise selective breeding - but genetic engineering could
usher in an entirely new approach to animal husbandry, whether
it's farmed fish or livestock.
"The concept of genetic improvement goes back a long, long
time," says Ronald Stotish, CEO of AquaBounty in Waltham,
Mass., which has invested approximately $60 million to get its
GM salmon approved. "Now, there is an opportunity to very
precisely alter genomes for specific traits. Not only is this
the latest and most precise form of genetic modification, it is
also the most regulated. That should be reassuring
But it is not. AquAdvantage Atlantic salmon eggs are at
leading edge of this new world in food production. As such,
they've become a lightning rod for consumer, animal welfare and
fishing and environmental groups critical of genetically
engineered animals. Supporters say transgenic fish will make
aquaculture more efficient and future supplies more abundant,
but critics argue that food suppliers shouldn't be messing with
AquaBounty began developing the fish to help meet worldwide
demand for a high-quality source of protein without harming the
environment or further depleting wild fisheries, says Stotish.
What allows the AquAdvantage salmon to grow to market size in
18 months, rather than the usual 36 months required for
traditional farmed Atlantic salmon, is the inclusion of a
growth hormone gene from the chinook salmon, plus a genetic
switch taken from the ocean pout (an Arctic, eel-like fish that
produces an antifreeze protein in its liver to allow it to
endure cold waters) that activates it. Salmon normally only
produce growth hormone in warm weather, but AquaBounty's
genetic alteration allows it to occur even in cold weather. In
all other respects the fish are identical to other Atlantic
salmon, farmed or wild, Stotish says.
The fish would be raised in inland tanks with sophisticated
containment procedures and mechanisms, which according to
AquaBounty sharply reduce the chance of environmental harm to
wild species. In addition, about 98 percent of the fish would
be sterile, and all of them would be female, Stotish adds.
In its detailed scientific review of the AquAdvantage
salmon, the FDA, which regulates genetically engineered animals
under new animal drug provisions of the Federal Food, Drug and
Cosmetics Act, didn't find anything harmful to human health or
to the environment. The agency must also decide if the fish
should be sold with a label identifying it as a genetically
modified product (see Point of View).
In September, however, the agency sent its scientific report
to the Veterinary Medicine Advisory Committee, which held three
days of public hearings followed by a 30-day comment period.
There is no timeline on when a decision will be made on the
application, says Laura Alvey, deputy director, office of
communications at the FDA's Center for Veterinary Medicine.
Before releasing a decision, the FDA also will publish an
environmental assessment followed by a 30-day comment
Comprised of animal health experts, committee members did
not find any evidence that contradicted the findings and
conclusions of the FDA staff, but they did express concern
about some of the studies
used to support those conclusions.
If the committee finds specific insufficiencies in the
application that would preclude an approval, AquaBounty would
be given the opportunity to address those problems, adds
Meanwhile, the anti-GM salmon contingency has been strong.
The Center for Food Safety lined up a coalition of 52
organizations opposing FDA approval of the GM salmon. At the
hearings they testified that the genetically engineered salmon
would pose a serious threat to wild Atlantic salmon, which is
listed as an endangered species, and claimed that the science
used to evaluate AquaBounty's claims about potential health
impacts was "sloppy."
In addition, 11 senators, led by Sen. Mark Begich
(D-Alaska), sent a letter to FDA Commissioner Margaret Hamburg
criticizing the agency for the process used to evaluate the
fish for human consumption.
"Given the inappropriate approval process, the lack of
transparency for over 10 years regarding this particular
application, and the myriad of potential human health and
ecological risks associated with production and consumption of
[genetically engineered] animals, we believe the AquaBounty
salmon should not be approved for human consumption," Begich
Despite regulations that would only allow the fish to be
grown on land, the coalition claims that approval would pose a
"serious threat" to the survival of wild Atlantic salmon
populations because they still fear the transgenic fish would
escape and out-compete their wild cousins for food.
The coalition cited research published in the Proceedings of
the National Academy of Sciences , which found that the release
of 60 GM salmon into a population of 60,000 wild fish would
lead to the extinction of the wild fish in less than 40
Opponents particularly challenged two studies AquaBounty
conducted on health aspects of the fish. The company reported
slightly elevated levels of insulin-like growth factor 1. The
presence of high levels of this hormone in the human
bloodstream may increase cancer risk, according to some
studies. But the question of whether food has any impact on
these hormone levels in the bloodstream has not yet been
determined. FDA analysis found that even if people ate large
quantities of the fish, the amount of hormone they might
consume would be insignificant.
The other potential health issue that worries critics is
whether there is a higher risk of increasing the allergenic
potential in the salmon because they've been genetically
Jaydee Hanson, a policy analyst at the Center for Food
Safety, called the sample sizes used in some of the GM salmon
studies woefully inadequate.
"The FDA advisory committee said 'you guys didn't do a good
job. You may think this is safe, but your studies don't show
that,'" Hanson says.
"The FDA shoehorned these big fish into their animal drug
rubric instead of creating a new testing protocol for these
genetically engineered fish. I would have thought both the FDA
and company would have made sure the statistical information
was impeccable, not weak as this is," he adds.
Michael Hansen, senior scientist at Consumer Union, the
organization that publishes Consumer Reports, adds that the
company and FDA reached conclusions about health issues using
testing methods that weren't sensitive enough, which he says is
just bad science.
"There were a lot of things that should have been done,
which weren't. Small sample sizes, insensitive testing methods
and failure to conduct tests based on fish production," Hansen
says. "This is going to set the bar for all that comes after
it. You cannot make conclusions in the absence of data. I was
actually surprised that the quality of the reports was so
Just the facts, please
Twenty years after GM salmon were first developed by
researchers Garth Fletcher and Choi Hew, and 14 after
AquaBounty (under a different company name), purchased the
technology, Stotish is frustrated by some of the allegations
and criticism leveled at AquaBounty in the public debate
surrounding FDA review of the company's application.
Some of the charges misrepresent the facts, are alarmist and
deliberately inflammatory, and "appear to be maliciously aimed
at creating fear in the public," he says.
On the environmental issues, for example, Stotish says
AquaBounty produces its eggs at a facility on Prince Edward
Island, Canada, and then ships them to another facility in
Panama where they are raised. Fish will only be raised in
closed-containment facilities. If the FDA does approve the
technology for commercial use, that will be a mandatory
condition. In addition, the company is working on a process
that will make 100 percent of
the GM salmon sterile.
With the allergy concerns, Stotish says the company asked
one of the world's experts on this issue to review the
company's study and findings. His analysis coincided with FDA
conclusions, which were that the AquaBounty salmon does not
appear to be any different from the traditional farmed
"This product will be very tightly regulated and the
oversight will be substantive," Stotish says.
He does, however, appreciate that the issue of genetic
engineering is an emotional one for many people. So were
earlier technologies that are now widely accepted, such as
selective breeding and artificial insemination. When these
techniques were first introduced, however, some critics not
only considered them ungodly, they said the practices involved
the abuse of animals. But those social mores changed with time,
"I think these salmon have been looked at more closely than
any other salmon in history," says L. Val Giddings, president
of PrometheusAB, a biotechnology-consulting
firm in Silver
Spring, Md. Giddings founded the firm after stints as VP of the
Biotechnology Industry Organization, and at the U.S. Department
of Agriculture where he was senior staff geneticist and
international team leader. He also worked with AquaBounty on
some matters unrelated to GM salmon.
Giddings first heard about the possibility of a genetically
engineered salmon from AquaBounty co-founder Elliot Entis at a
conference in Europe 15 years ago, and admits he was
"At the time I thought, 'The last thing we need is another
threat to the wild salmon,'" Giddings recalls, but as time
passed and he learned more about the work the company was
doing, his views changed.
Because AquAdvantage salmon will have to be raised in
closed-containment land-based facilities, the danger of escape
into the wild is extremely remote, Giddings says. "That issue
has been taken off the table, and it's just not honest for
these people to claim that these salmon will pose a threat to
the wild population.
"At this point, every reasonable question about this fish
has not only been asked, but satisfactorily answered," Giddings
adds. "It is no different from any other salmon except that it
Most of the Atlantic salmon currently sold in the United
States is imported, which means high shipping costs make the
fish expensive and give it a large carbon footprint. The long
distances from farm to store also have an impact on quality. By
the time salmon reach display cases, they've already been out
of the water at least a week, Giddings says.
In a recent article in the Natural Resource Report, James
Greenwood, president and CEO of the Biotechnology Industry
Organization, points out that faster-growing genetically
engineered salmon could help restore America's languishing
domestic fish-farming industry.
AquaBounty envisions farming operations located near major
population centers, which would trim costs, lower energy
consumption and deliver a fresher product to supermarkets.
"I'll be stunned if this salmon doesn't take off and sell
like hotcakes," says Giddings.
But no fish will appear in supermarkets any time soon. Even
if the FDA does approve them, the earliest GM salmon could be
on the market is 2013 because of the growout period.
Farming for the future
Although the idea of eating genetically modified animals is
frightening to many people around the world, most food-security
experts recognize that in order to adequately feed a world
population expected to hit 9 billion people by 2050,
genetically modified food and biotechnology will have to be
part of a global strategy.
In an article published in the journal Science earlier this
year, a group of 10 scientists outlined the global needs and
challenges. They said world food production in the next 40
years must increase between 70 and 100 percent.
"Growing competition for land, water and energy, in addition
to the overexploitation of fisheries, will affect our ability
to produce food, as will the urgent requirement to reduce the
impact of the food system on the environment. The effects of
climate change are a further threat," the scientists said in
the article, published Feb. 12.
The United Nations in May added to that grim assessment with
a study saying 80 percent of world fish stocks are fully
exploited or overexploited. Unless these trends are reversed,
by mid-century fisheries could collapse worldwide.
Nearly half of all seafood consumed worldwide is now farmed,
but new projections for the industry about rising demand far
exceed earlier studies based solely on population growth,
according to the Global Aquaculture Alliance, an industry trade
group in St. Louis.
"Rising global demand for seafood, driven mainly by a
rapidly growing middle class in China and other Asian nations,
is putting new pressure on the aquaculture industry to find
sustainable ways to increase productivity," according to new
data experts presented at the group's annual GOAL meeting of
international aquaculture and seafood industry leaders in Kuala
Economist Ragnar Tveteras told conference attendees that
China, the world's largest aquaculture producer, is
increasingly importing seafood to meet domestic demand. He says
the country will shift from being a net seafood exporter to a
net seafood importer next year, and per-capita consumption is
expected to double between 2008 and 2020.
To sustainably increase seafood production to meet rising
demand, producers must adopt improved technologies that produce
more seafood with fewer resources, says George Chamberlain, GAA
During the conference, 132 industry leaders were asked their
opinion about GM salmon and 58 percent said exploration of the
technology should continue using carefully monitored and
controlled land-based systems.
"Judicious and responsible incorporation of GM technology
has the potential to be good news for consumers and the
environment," Chamberlain says. "However, insufficient data is
available about AquaBounty salmon to make a full assessment. If
proper safeguards are in place to prevent escapes, commercial
trials would help answer questions about economic viability in
land-based systems and consumer acceptance."
If the FDA does approve the salmon for human consumption,
consumers will have the ultimate say about its success or
Red Lobster, a subsidiary of Darden Restaurants in Orlando,
Fla., is the world's largest casual-dining seafood restaurant
with nearly 700 stores in the United States and Canada. It is
also the largest overnight shipper of fresh fish in the
restaurant industry, and could be a retail market maker if it
agrees to sell the GM salmon. But no such decision has been
made yet, a Darden spokesman says.
"It's too early in the game for us to know whether we will
consider this product," says Rich Jeffers.
Sam King of King's Seafood Co., which has restaurants
in California and operates its own seafood
distribution company, says the company
will consider selling
the GM salmon if it gets approved.
"I think we need to be careful and the FDA needs to be
careful, but this sounds like one of those moments that could
change the course of history once we figure out how to do
things," King says. "This is going to change aquaculture."
With surging population growth and rapidly declining fish
stocks throughout the world's oceans, the only way to meet
global dietary needs in the future is if technology
"We have the tools to feed the world if we choose to use
them," Stotish says. "We're hopeful because the science is good
that the FDA will eventually approve this product."
For now, everyone is in a holding pattern awaiting the FDA's
final decision - AquaBounty, critics, other biotech companies
and companies interested in starting commercial farming
operations, including AquaBounty's Entis.
If the FDA suddenly reverses course and decides to reject
AquaBounty's applications, the reasons would have to be
detailed in a letter.
At that point, the company would request a meeting to
discuss the issues, "and attempt to address any agency concerns
in a constructive and responsive manner," Stotish says.
If the fish is approved and other companies want to open
facilities, a supplement to AquaBounty's application would have
to be filed. The supplement would include site-specific
information on design, containment, size and an environmental
assessment would be prepared.
FDA inspectors would visit the site and determine if it
conformed to the submission information, and prepare a report.
Only after the review, inspection and administrative approval
of the new location would AquaBounty be able
to ship eggs to
the site for growout.
This process is analogous to the evaluation and addition of
alternate manufacturing sites for a veterinary drug, Stotish
Less clear is what options opponents will have if the salmon
is approved. They likely won't have any avenue for appeal to
the FDA, which means their only recourse would be legal
AquaBounty will likely never win over its most ardent
critics. But the company may be able to assuage the public
outcry, especially if it persuades companies that sell its GM
salmon with labels that clearly identify the fish as such. For
now, the food industry waits for the FDA's final word.
Contributing Editor Stuart Hirsch lives in Indianapolis