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CFS Sues FDA to Regulate Genetically Engineered GloFish

January 14, 2004

The Center for Technology Assessment (CTA) and Center for Food Safety (CFS) today filed a lawsuit in Federal District Court to block the sale of the first ever genetically engineered pet, called the GloFish. The lawsuit seeks a court order stating that the transgenic fish are subject to Federal regulation and cannot be sold further without proper approvals. Yorktown Technologies, LLP, of Austin, Texas, began selling the gene-altered fish nationally this month, claiming that it needs no Federal permit to do so. The bright red fish was created by adding genes from a coral species to the genome of the common black andwhite zebra danio. Recent research also has revealed that the GloFish was engineered to contain animal and human viruses and as well as antibiotic resistance genes, all of which can pose human and animal health hazards.

“Allowing the unregulated sale of GloFish provides a gateway for genetically engineered fish to find their way onto our dinner plates and into our environment,” said Joseph Mendelson, CFS Legal Director. “By not stepping in to regulate these fish, the FDA is establishing a dangerous precedent for all future gene-altered animals, whether created as food or pet fads. We are suing to prevent the GloFish from opening the floodgates for all manner of genetically engineered animals.”

The CTA/CFS action seeks a ruling that the U.S. Food and Drug Administration (FDA) has authority over genetically engineered pets. In November 2003, CFS requested that FDA formally announce its policy on engineered ornamental fish. So far, FDA has declined to regulate genetically engineered pet fish or to offer a timetable for issuing the agency’s policy.

The California Fish and Game Commission is the only state agency to rule on the engineered zebra fish. On December 3, the Commission said federal regulation was needed and cited ethical concerns in refusing to allow the sale of the genetically engineered fish in that state.

“The genetic engineering of domesticated and wild animals creates profound moral and environmental issues for society,” said CTA Executive Director Andrew Kimbrell. “The Bush administration’s hands-off approach to this technology has created a regulatory and ethical free-fall. It is time for the courts to intervene and force our government agencies to protect the public, not the just the interests of a few biotech companies.”

The National Academy of Sciences echoed the need for federal regulation in a 2003 report on transgenic animals that emphasized the risks of genetically engineered fish.

The complaint in the lawsuit represents the first-ever legal action seeking to block sale of a genetically engineered animal.

To view the complaint, click HERE.