Food and Drug Administration Won't Regulate First Biotech Pet

12/10/2003 Food and Drug Administration Won't Regulate First Biotech Pet - 12/10 AP

Singapore scientists gave the naturally black-and-silver zebra fish a fluorescent red glow by inserting a sea anemone gene.

"Because tropical aquarium fish are not used for food purposes, they pose no threat to the food supply," the FDA said in a statement posted on its Web site.

"There is no evidence that these genetically engineered zebra danio fish pose any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States. In the absence of a clear risk to the public health, the FDA finds no reason to regulate these particular fish."

The food supply argument is disingenuous because the fish would have been regulated as an animal drug, the same provision the agency is using to extensively review genetically modified salmon that are intended for human consumption, said Andrew Kimbrell, executive director of The Center for Food Safety.

The center will quickly sue the FDA, if possible before the trademarked GloFish reaches pet stores Jan. 5, Kimbrell said, asking a judge to order the agency to regulate the bio-engineered fish.

"Otherwise we're in a regulatory free fall," with other transgenic organisms likely to hit the market with no oversight, Kimbrell said. "My major fear is that this sets a frightening precedent."

The FDA did review potential health or environmental dangers from the fish before announcing its decision, said spokesman Brad Stone. The FDA's Center for Veterinary Medicine led the review in cooperation with the agency's Center for Food Safety and Applied Nutrition, the Department of Agriculture and the Environmental Protection Agency.

"A fair amount of time and effort went into evaluating this particular matter," Stone said.

With the FDA's decision, and barring a federal court order, the GloFish will be legally marketed in every state except California, the only state that regulates genetically engineered fish to protect its native fish populations.

California's Fish and Game Commission voted last week not to exempt the biotech fish, though commission members and the Department of Fish and Game decided it posed no environmental or health risk. A majority of commissioners balked on ethical grounds, deciding there is no overriding public benefit from approving a bio-engineered household pet, though the state allows transgenic species for scientific or medical purposes.

Alan Blake, CEO of Austin, Texas-based Yorktown Technologies, which will market the Florida-grown fish, said he was pleased by Tuesday's FDA decision.

Opponent Kimbrell, however, said the California decision buys time for a court challenge.

"It's against the law for anyone to import those things into the state of California," Kimbrell said. "That will be a damper, I think, on any quick commercialization of this product."

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