The Center for Food Safety, Food and Water Watch, Friends of the
Earth and other groups allege in the lawsuit, filed on Wednesday,
that the Food and Drug Administration (FDA) failed to consider all
of the environmental risks of the fish when the agency approved it
The FDA also cleared the product, made by Massachusetts-based
AquaBounty Technologies, without having the proper authority to
regulate genetically engineered animals produced for food, according
to the complaint.
The agency declined to comment on the lawsuit on Thursday. Its
approval of AquaBounty salmon followed a 20-year review and was the
first such approval for an animal whose DNA has been scientifically
AquaBounty is confident the FDA's approval will stand, Chief
Executive Ron Stotish said in a statement. The agency was
"extraordinarily thorough and transparent in the review and approval
of our application," he said.
The company has said its salmon can grow to market size in half the
time of conventional salmon, saving time and resources.
However, the FDA approval process included "an extremely limited
environmental assessment" that did not fully evaluate the potential
for AquaBounty salmon to escape from the facilities where they are
grown, among other risks, according to the lawsuit.
The legal challenge comes as the U.S. food industry is facing
increased pressure from consumers to provide more information about
the use of genetically engineered ingredients.
General Mills Inc and other major food companies are rolling out new
disclosures on products to comply with a Vermont law that will
require labels on foods made with genetically modified organisms, or
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Major retailers, including Kroger Co and Target Corp, have already
said they do not plan to stock AquaBounty salmon on store shelves.
It is not yet available for sale.
Activists worry the FDA's approval of the salmon will serve as a
precedent for other genetically engineered food animals.
Their lawsuit seeks to prohibit the FDA from taking further action
on the fish or any other genetically engineered animal for human
consumption until Congress grants an agency clear authority over
The case is Institute for Fisheries Resources et al v Sylvia Mathews
Burwell et al, U.S. District Court, Northern District of California,
(Reporting by Tom Polansek; Editing by Richard Pullin and Andrew
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