Activists sue FDA, claim agency has no authority to approve genetically modified animals

Environmental groups filed a lawsuit against the U.S. Food and Drug Administration [March 31], 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.

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An FDA spokeswoman said the agency doesn’t comment on pending litigation.

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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.