Federal Court rules that FDA approval of genetically engineered salmon violated federal law
By Dan Bacher |
San
Francisco - A coalition of environmental groups, commercial and
recreational fishing organizations and one Indian Tribe has won a huge victory
in the battle to stop the Food and Drug Administration’s approval of
genetically engineered salmon for human consumption in the U.S.
On
November 5, the U.S. District Court for the Northern District of
California ruled the Food and
Drug Administration (FDA) violated core environmental laws in approving the
genetically engineered salmon, according to a press release from
the Center for Food Safety (CFS) and Earthjustice.
“The
Court decided that FDA ignored the serious environmental consequences of
approving genetically engineered salmon and the full extent of plans to grow
and commercialize the salmon in the U.S. and around the world, violating the
National Environmental Policy Act,” the groups stated.
““The
Court also ruled that FDA’s unilateral decision that genetically engineered
salmon could have no possible effect on highly-endangered, wild Atlantic salmon
was wrong, in violation of the Endangered Species Act. The Court ordered FDA to
go back to the drawing board and FDA must now thoroughly analyze the
environmental consequences of an escape of genetically engineered salmon into
the wild,” the groups said.
In
his ruling, U.S. District Judge Vince Chhabria concluded:
"The FDA did not, however, meaningfully analyze what might
happen to normal salmon in the event the engineered salmon did survive and
establish themselves in the wild. Even if this scenario was unlikely, the FDA
was still required to assess the consequences of it coming to pass. This
is especially true because the FDA knew that the company’s salmon operations
would likely grow, with additional facilities being used for
farming. Obviously, as the company’s operations grow, so too does the
risk of engineered salmon escaping. Thus, it was particularlyimportant at the
outset for the agency to conduct a complete assessment of the risks posed by
the company’s genetic engineering project, including an assessment of
the consequences for normal salmon if the engineered salmon established
themselves in the wild."
The
plaintiffs in the case, represented by the Center for Food Safety and
Earthjustice, include the Institute for Fisheries Resources, Pacific Coast
Federation of Fishermen’s Associations, Cascadia Wildlands, Center for
Biological Diversity, Center for Food Safety, Ecology Action Centre, Food and
Water Watch, Friends of the Earth, Friends of Merrymeeting Bay, Golden Gate
Salmon Association, and the Quinault Indian Nation
“Today’s
decision is a vital victory for endangered salmon and our oceans,” said
George Kimbrell, CFS legal director and counsel in the case. “Genetically
engineered animals create novel risks and regulators must rigorously analyze
them using sound science, not stick their head in the sand as officials did
here. In reality, this engineered fish offers nothing but unstudied risks. The
absolute last thing our planet needs right now is another human-created crisis
like escaped genetically engineered fish running amok.”
In
2016, the Center for Food Safety (CFS) and Earthjustice—representing a
broad client coalition of environmental, consumer, commercial and recreational
fishing organizations and the Quinault Indian Nation—sued the FDA for
approving the first-ever commercial genetically engineered animal, an Atlantic
salmon engineered to grow twice as fast as its wild counterpart, the groups
said.
The
genetically engineered salmon was produced by AquaBounty Technologies,
Inc. with DNA from Atlantic salmon, Pacific king salmon, and Arctic ocean
eelpout. This marks the first time any government in the world has approved a
commercially genetically engineered animal as food.
AquaBounty
recently reported a strong balance sheet going into
the fourth quarter of 2020 and announced that it had selected
Mayfield, Kentucky, U.S.A., as its favored site for a future
10,000-metric-ton (MT) land-based salmon farms. However,
the FDA failed to consider and study the environmental risks of what many
opponents of genetically engineered salmon call “frankenfish.”
“When
GE salmon escape or are accidentally released into the environment, the new
species could threaten wild populations by mating with endangered salmon
species, outcompeting them for scarce resources and habitat, and/or introducing
new diseases,” the groups said. “The world’s preeminent experts on GE fish and
risk assessment, as well as biologists at U.S. wildlife agencies charged with
protecting fish and wildlife, heavily criticized FDA’s approval for failing to
evaluate the impacts of GE salmon on native salmon populations. Yet FDA ignored
their concerns in the final approval.”
“This
decision underscores what scientists have been telling FDA for years—that
creating genetically engineered salmon poses an unacceptable risk if the
fish escape and interact with our wild salmon and that FDA must understand that
risk to prevent harm,” said Earthjustice managing attorney Steve
Mashuda. “Our efforts should be focused on saving the wild salmon
populations we already have—not manufacturing new species that pose yet another
threat to their survival.”
According
to the groups, studies have shown that there is a high risk for genetically
engineered organisms to escape into the natural environment, and that
genetically engineered salmon can crossbreed with native fish. So-called “transgenic
contamination”—where genetically engineered crops cross-pollinate or establish
themselves in nearby fields or the wild—has become common. These contamination
episodes have cost U.S. farmers billions of dollars over the past decade. In
wild organisms like fish, it would be even more damaging.
The
Court also rejected FDA’s argument that it “lacked authority” to consider the
adverse environmental impacts of GE animals, including the GE salmon. To find
otherwise, the Court said, would lead to “absurd possibilities,” like approval
of GE animals that could cause serious harm to other life. The Court held FDA
had to consider environmental risks in its decision.
“The
lawsuit also highlights FDA’s failure to protect the environment and consult
wildlife agencies in its review process, as required by federal law. U.S.
Atlantic salmon, and many populations of Pacific salmon, are protected by the
Endangered Species Act and in danger of extinction,” the groups said.
“Salmon
are keystone species and unique salmon runs have sustained people and wildlife
for thousands of years. Diverse salmon runs today remain essential to
indigenous food sovereignty, sustaining thousands of American fishing families,
and are highly valued in domestic markets as a healthy, domestic, green’ food,”
the groups stated.
Fawn
Sharp, Quinault Indian Nation President, said, “Salmon are at the center of our
cultural and spiritual identity, diet, and way of life. It’s unconscionable and
arrogant to think man can improve upon our Creator’s perfection as a
justification for corporate ambition and greed. Our responsibility as
stewards of our sacred salmon demands we aggressively protect their natural
habitat and genetics. We applaud today’s court decision; our prayers were
answered and justice prevailed.”
“It’s
a terrible idea to design genetically engineered ‘Frankenfish’ which, when they
escape into the wild (as they inevitably will), could destroy our irreplaceable
salmon runs,” said Mike Conroy, Executive Director of the Pacific Coast
Federation of Fishermen’s Associations (PCFFA). “Once engineered genes are
introduced into the wild salmon gene pool, it cannot be undone. This decision
is a major victory for wild salmon, salmon fishing families and dependent
communities, and salmon conservation efforts everywhere.”
“Salmon
fishermen and women don’t want to see these lab-made salmon in our waters nor
in any market or restaurant where salmon is sold,” said John McManus,
president of the Golden State Salmon Association. “The federal Food
and Drug Administration clearly let America down when it chose to overlook the
environmental risk these fish pose.”
“Genetically
engineered salmon place wild salmon at risk and set a dangerous precedent for
other genetically engineered animals, like cows and chickens designed to fit
into factory farms, to enter the food system. We applaud the court for this
carefully-reasoned decision,” said Dana Perls, Food and Technology program
manager at Friends of the Earth U.S. “All products made with genetic
engineering, especially live animals like genetically engineered salmon, should
undergo thorough and precautionary assessment for impacts to our health and
environment, be properly regulated and clearly labeled before entering the
market.”
Fishermen,
Tribes, environmentalists and public interest groups have been fighting the
approval of genetically engineered salmon for human consumption for nearly two
decades.
The
Yurok Tribe, the largest Indian Tribe in California with over 6,000 members, in
December 2015 banned genetically engineered salmon and all genetically
engineered organisms (GEOs) on their reservation on the Klamath River in the
state’s northwest region.
The
Yurok ban came in the wake of the federal Food and Drug Administration
(FDA) decision on November 19, 2015 to approve genetically engineered salmon,
dubbed “Frankenfish,” as being fit for human consumption.s
On
December 10, 2015, the Yurok Tribal Council unanimously voted to enact the
Yurok Tribe Genetically Engineered Organism (“GEO”) Ordinance. The vote took place
after several months of committee drafting and opportunity for public comment,
according to a news release from the Tribe and Northern California Tribal Court
Coalition (NCTCC).
This
ordinance was apparently the first of its kind in the U.S. to address the FDA’s
approval of AquaBounty Technologies’ application for AquAdvantage Salmon.
“The
Tribal GEO Ordinance prohibits the propagation, raising, growing, spawning,
incubating, or releasing genetically engineered organisms (such as growing GMO
crops or releasing genetically engineered salmon) within the Tribe’s territory
and declares the Yurok Reservation to be a GMO-free zone. While other Tribes,
such as the Dine’ (Navajo) Nation, have declared GMO-free zones by resolution,
this ordinance appears to be the first of its kind in the nation,” the Tribe
said.
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