Sep 20, 2010 2:01 PM
WASHINGTON (AP) - Federal food regulators pondered Monday
whether to say, for the first time, that it's OK to market a
genetically engineered animal as safe for people to eat.
The Food and Drug Administration is holding two days of hearings
on a request to market genetically modified salmon. Ron Stotish,
CEO of AquaBounty, the Massachusetts company that made the
marketing request, said at the meeting Monday that his company's
fish product is safe and environmentally sustainable.
Critics, however, call the modified salmon "frankenfish" that
could cause allergies in humans and the eventual decimation of the
wild salmon population. An FDA advisory committee is reviewing the
science of the genetically engineered fish this week and hearing
such criticisms as the agency ponders approval.
The FDA has already said that the salmon, which grows twice as
fast as its conventional "sisters," is as safe to eat as the
Whether the public will have an appetite for it is another
matter. Genetic engineering is already widely used for crops, but
the government until now has not considered allowing the
consumption of modified animals. Although the potential benefits -
and profits - are huge, many individuals have qualms about
manipulating the genetic code of other living creatures.
Part of the two-day hearing will focus on labeling of the fish.
It is possible that if the modified salmon is approved, consumers
would not even know they were eating it. Current FDA regulations
only require modified foods to be labeled as such if the food is
substantially different than the conventional version, and the
agency has said that the modified salmon is essentially the same as
the Atlantic salmon.
Approval of the salmon would open the door for a variety of
other genetically engineered animals, including an environmentally
friendly pig that is being developed in Canada or cattle that are
resistant to mad cow disease.
"For future applications out there the sky's the limit," said
David Edwards of the Biotechnology Industry Association. "If you
can imagine it, scientists can try to do it."
AquaBounty submitted its first application for FDA approval in
1995, but the agency did not decide until two years ago to consider
applications for genetically engineered animals - a move seen as a
breakthrough by the biotechnology industry.
Genetically engineered - or GE - animals are not clones, which
the FDA has already said are safe to eat. Clones are copies of an
animal. With GE animals, their DNA has been altered to produce a
In the case of the salmon, AquaBounty has added a growth hormone
from a Chinook salmon that allows the fish to produce their growth
hormone all year long. The engineers were able to keep the hormone
active by using another gene from an eel-like fish called an ocean
pout that acts like an on switch for the hormone, according to the
company. Conventional salmon only produce the growth hormone some
of the time.
In documents released ahead of the hearing, the FDA said there
were no biologically relevant differences between the engineered
salmon and conventional salmon, and there is a reasonable certainty
of no harm from its consumption. FDA scientists speaking Monday
said there are very few differences between the modified and
Critics have two main concerns: The safety of the food to humans
and the salmon's effect on the environment.
Because the altered fish has never been eaten before, they say,
it could include dangerous allergens, especially because seafood is
highly allergenic. They also worry that the fish will escape and
intermingle with the wild salmon population, which is already
endangered.They would grow fast and consume more food to the
detriment of the conventional wild salmon, the critics fear.
A wide range of environmental, food safety and consumer groups
have argued that more public studies are needed and the current FDA
process is inadequate because it allows the company to keep some
proprietary information private. Modified foods are regulated under
the same process used for animal drugs.
"It is outrageous to keep this vital information secret," said
Wenonah Hauter, director of the advocacy group Food & Water Watch.
"Consumers have a right to know what FDA is trying to allow into
our food supply."
Dr. Michael Hansen, senior scientist at Consumers Union, the
publisher of Consumer Reports, says the agency is relying on too
little data, much of which is supplied by the company itself.
Stotish countered that the company has more than addressed the
concerns, and his product has come under much more scrutiny than
"This is perhaps the most studied fish in history," he said.
"Environmentally this is a very sustainable technology."
The company has several safeguards in place to allay concerns.
All the fish would be bred female and sterile, though a small
percentage may be able to breed. They would be bred in confined
pools where the potential for escape would be very low.
In its environmental analysis of the fish released earlier this
month, the FDA agreed with the company that there are enough
safeguards in place.
Stotish says the fish would be bred in better conditions than
many of the world's farmed salmon, and could be located closer to
population centers to help feed more people. The company has also
said the increase in engineered salmon production could help
relieve endangered wild salmon populations.
The company is also arguing that the fish do not need to be
labeled as genetically engineered, so the average customer would
not know if they were eating the modified product or the
"This fish is identical to the traditional food," maintained
Stotish. "The label could even be misleading because it implies a
difference that doesn't exist."
If approved, the fish could be in grocery stores in two years,
the company estimates.