Lawsuit Challenges FDA's Right to Approve Genetically Modified Animals
01 April 2016 - 1:10AM
Dow Jones News
Environmental groups filed a lawsuit against the U.S. Food and
Drug Administration Thursday, challenging the agency's authority to
approve genetically modified animals used for food.
The lawsuit is seeking to overturn the FDA's November approval
of a modified salmon that grows twice as fast as wild versions, and
block its jurisdiction over a range of new biotech animals under
development, such as a fast-growing trout and hornless dairy
cows.
The lawsuit, filed in U.S. District Court for the Northern
District of California, accuses the FDA of overstepping its
authority in approving the salmon, developed by AquaBounty
Technologies Inc., a unit of Intrexon Corp. The fish was the first
genetically modified animal cleared for human consumption.
The groups said the FDA's regulation of such technology under
the Federal Food, Drug and Cosmetic Act—regulating genetic
modification under provisions covering animal drugs—goes beyond the
law's scope.
"Congress never intended that law to cover these novel,
man-made, genetically engineered animals," said George Kimbrell,
senior attorney for the Center for Food Safety, which filed the
lawsuit along with Friends of the Earth, the Center for Biological
Diversity, and other groups.
An FDA spokeswoman said the agency doesn't comment on pending
litigation.
The legal challenge is the latest front in an expanding debate
over the use of genetically modified organisms, or GMOs, in food
production.
In the U.S., where more than 90% of corn and soybean acres are
sown with biotech crops resistant to bugs and herbicides, major
food companies are beginning to roll out labels denoting GMO
ingredients, in response to a Vermont law set to take effect in
July.
Proponents of the technology say that adding non-native genes to
plants helps farmers raise sturdier crops using less pesticides. In
the case of the salmon, backers argue that genetic engineering can
help produce filets using 20%-25% less feed.
Critics say that GMO crops rely on weedkillers that, when used
heavily, contribute to the development of herbicide-resistant weeds
that can choke out GMO and organic crops alike.
The groups behind the lawsuit over the AquaBounty salmon warn it
could escape and threaten wild salmon populations, a risk
AquaBounty officials have downplayed.
Other GMO food animals are in the works.
AquaBounty officials said in a February regulatory filing that
the firm is working on a modified trout that adds weight faster
than conventional rainbow trout, and is preparing studies for
regulatory review.
Minnesota-based Recombinetics Inc. has been using gene-editing
technology to develop dairy cattle that don't grow horns, which
typically are cut off to ensure the animals don't injure workers or
one another, a process that has drawn criticism from animal welfare
groups.
The FDA has jurisdiction over animals genetically engineered for
other purposes.
The agency in March sought public comment on a plan by Oxitec
Ltd., another Intrexon subsidiary, to test genetically modified
mosquitoes in Florida as a pesticide-free way to cull populations
that could carry the Zika virus.
Mr. Kimbrell said the groups' lawsuit is aimed at GMO animals
raised for food production, though it could "indirectly affect" the
FDA's jurisdiction over other modified animals.
Write to Jacob Bunge at jacob.bunge@wsj.com
(END) Dow Jones Newswires
March 31, 2016 09:55 ET (13:55 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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