INSIDER Law
Lawsuit Challenges FDAs Approval of GE Salmon

Lawsuit Challenges FDAs Approval of GE Salmon

<p>The lawsuit challenges FDA&#8217;s claims that it can regulate GE animals as &#8220;animal drugs" under federal law, and claims FDA failed to protect the environment and consult wildlife agencies in its review process.</p>

A coalition of consumer, environmental and fishing organizations filed a lawsuit in northern California to contest FDA’s approval of a salmon that has been genetically engineered.

The development poses a threat to AquaBounty Technologies Inc., which intends to introduce the genetically engineered (GE) salmon for commercial sale and spent years preparing for FDA approval.

AquaBounty will manufacture the fish at a facility on Prince Edward Island in Canada, transport the eggs to a separate facility in Panama where they will grow to maturity, and then the fish will be processed and shipped to the United States for sale, according to the 63-page complaint.

FDA’s approval of AquaBounty’s application “marks the first occasion in history where any country has authorized the mass production of a GE animal of any variety to be sold as food," the lawsuit declared. “Accordingly, this action will serve as a precedent for the assessment and regulation of all potential future GE animals manufactured for human consumption, and for review of their impacts on public health and the environment."

The lawsuit challenges FDA’s claims that it can regulate GE animals as “animal drugs" under the 1938 Federal Food, Drug and Cosmetic Act (FDCA). In a press release, the coalition said FDA failed to protect the environment and consult wildlife agencies in its review process.

“FDA’s decision is as unlawful as it is irresponsible," said George Kimbrell, senior attorney for the Center for Food Safety and co-counsel for the plaintiffs, in a written statement. “This case is about protecting our fisheries and ocean ecosystems from the foreseeable harms of the first-ever GE fish, harms FDA refused to even consider, let alone prevent. But it’s also about the future of our food: FDA should not, and cannot, responsibly regulate this GE animal, nor any future GE animals, by treating them as drugs under a 1938 law."

The coalition of plaintiffs alleged FDA violated the FDCA, National Environmental Policy Act, Endangered Species Act, Federal Food and Drug Amendments Act of 2007, and the Administrative Procedure Act because the agency failed to adequately examine “the full range of potentially significant environmental and ecological effects presented by the AquaBounty application." Among other requests, the lawsuit seeks a declaration that FDA’s decision was unlawful and an injunction requiring FDA to “withdraw its assertion over GE animals."

An FDA spokeswoman said the agency does not comment on pending litigation. The complaint names as defendants Sylvia Matthews Burwell, Secretary of the U.S. Department of Health and Human Services; FDA Commissioner Robert Califf, M.D., FDA; and the U.S. Fish and Wildlife Service.

Last November in approving AquaBounty’s application, FDA determined food from the fish is safe to eat, the part of DNA that makes the fish grow faster won’t harm the animal, and AqauBounty’s claim that the bioengineered fish will grow faster has been met.

“AquaBounty is confident that the approval will stand, and that the FDA has been extraordinarily thorough and transparent in the review and approval of our application," AquaBounty CEO Ron Stotish said in a written statement.

The lawsuit was filed in the U.S. District Court for the Northern District of California by the Pacific Coast Federation of Fishermen’s Associations, Institute for Fisheries Resources, Golden Gate Salmon Association, Kennebec Reborn, Friends of Merrymeeting Bay, Ecology Action Centre, Food & Water Watch, Center for Biological Diversity, Friends of the Earth, Cascadia Wildlands and Center for Food Safety.

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