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FDA Nears Approval of Genetically Engineered Salmon

Les Blumenthal

Biotech crops are spreading worldwide, with 14 million farmers growing them in 25 countries, including the U.S. About 330 million acres are planted globally, an 80-fold increase since 1996. (photo by Flickr user denn)

WASHINGTON - They may not be the 500-pound
"Frankenfish" that some researchers were talking about 10 years ago, but
a Massachusetts company says it's on the verge of receiving federal
approval to market a quick-growing Atlantic salmon that's been
genetically modified with help from a Pacific Chinook salmon.

Though genetically engineered crops such as corn
and soybeans have been part of the American diet for several years, if
the Food and Drug Administration approves it, the salmon would be the
first transgenic animal headed for the dinner table.

"I would
serve it to my kids," said Val Giddings, who worked as a geneticist at
the U.S. Agriculture Department for a decade before becoming a private

The financial rewards could be enormous.

Aquaculture is
already an $86 billion-a-year business, with nearly half of all fish
consumed globally farm raised. As wild stocks dwindle and the world's
population heads toward 9 billion, fish farmers will be looking for fish
that will be market-ready quicker.

Even so, skeptics abound.

persist about possible health risks from genetically modified food in
general, but concerns about bioengineered salmon also extend to the

Farmed salmon are raised in net pens in coastal
waters along Washington state, Maine and British Columbia. Most
commonly, the fish being raised are Atlantic salmon, and the fear is
they'll escape and compete with endangered native stocks. By some
estimates, between 400,000 and 1 million Atlantic salmon have escaped
into the wild from the 75 or so net-pen operations in British Columbia.

Purdue University study using a computer model, widely criticized by
the biotechnology industry, showed that if 60 transgenic fish bred in a
population of 60,000 wild fish, the wild fish would be extinct in 40

"We've seen assurances in the past from industry and
regulators that there won't be catastrophic consequences like the Gulf
oil spill," said George Kimbrell, a senior staff attorney for the Center
for Food Safety. "We have a cultural amnesia about these things."

the FDA approves the transgenic salmon, his group would consider
litigation to stop it, Kimbrell said.

AquaBounty, which calls its
super salmon an "advanced hybrid" rather than a transgenic fish, said
they're safe to eat and would be raised in contained farming operations
that could be based inland rather than along coastal waters. And the
modified fish, all females, would be sterile so that they couldn't breed
with wild fish if any escaped, the company said.

fish grow faster but not bigger that normal Atlantic salmon. The company
says that genetically modified salmon are identical to regular salmon
in every way except for the genes that have been added.

researchers have added a growth hormone gene from the Chinook salmon as
well as an on-switch gene from the ocean pout, a distant relative of the
salmon, to a normal Atlantic salmon's roughly 40,000 genes. Salmon
normally feed only during the spring and summer, but when the on-switch
from the pout's gene is triggered, they eat year round.

The result
is a transgenic salmon that grows to market size in about half the time
as a normal salmon - 16 to 18 months, rather than three years.

would market the eggs from a transgenic salmon, not the actual fish.

first filing for approval a decade ago to bring the fish to market, the
company said in a recent press release that the FDA's Center for
Veterinary Medicine has reviewed in detail five of the seven sections of
its application.

"The company believes the reviews for the
remaining two parts of the application are very nearly complete,"
AquaBounty said, adding that its management was "confident of a
successful outcome in the near future."

The FDA doesn't comment on
pending applications, though a public hearing on the AquaBounty
application could come as early as this fall. Such public hearings can
signal the FDA is close to a decision.

Once approved, AquaBounty
said it could start marketing the eggs from transgenic salmon within two
or three years. The company is also reportedly developing transgenic
tilapia and trout.

Scientists elsewhere are working on cattle that
would be resistant to mad cow disease, and researchers in Canada have
developed an "enviropig," which would produce manure with less harmful
levels of phosphorus.

Biotech crops are spreading worldwide, with
14 million farmers growing them in 25 countries, including the U.S.
About 330 million acres are planted globally, an 80-fold increase since

Giddings, the former USDA geneticist, said that 77 percent
of the global soybean harvest was transgenic, 26 percent of the feed
corn, 21 percent of canola and 49 percent of cotton. All told, Gidding
said, there are 60 to 70 transgenic crops ranging from papayas to yellow

"All have been reviewed by the FDA," said Giddings, who
also worked for a leading biotech industry group. "There is no greater
risk from eating transgenic crops than eating non-transgenic crops."

officials weren't available for comment, but the company's publicist
referred calls to Giddings.

Giddings said he hadn't eaten a
transgenic salmon, but people he'd talked to who'd attended AquaBounty
fish fries said they taste just like non-transgenic fish. He dismisses
health safety concerns and fears that the fish could pose a threat to
native stocks.

"Transgenic foods are subjected to more scrutiny
than any other food in history," he said.

However, critics say
there are no guarantees the transgenic salmon would be raised in
contained, inland pens, and that claims of sterility can be overblown.
The company says that 99 percent of the transgenic fish will be sterile,
a level that meets FDA requirements.

"I hope that's true," said
Eric Hoffman, who works on genetic technology policy for Friends of the

FDA regulations don't specifically address whether
transgenic food is safe for public health and the environment, Hoffman
said, and the approval process is so closed it's impossible to tell
whether fish raised from AquaBounty's eggs will have to be labeled as
transgenic. Products made from transgenic crops in the U.S. don't have
to carry a special label.

"This is all about corporate profit and
not public health," Hoffman said.

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