In Reversal, FDA Says It Will Not Regulate Bioengineered Fish
The U.S. Food and Drug Administration, reversing an earlier decision to regulate all genetically altered animals, announced on Tuesday that it sees no need to scrutinize a tropical zebra fish bioengineered to glow red and headed for sale in pet stores next month.
A Texas-based company and a pair of tropical fish farms in Florida plan to market the trademarked GloFish beginning Jan. 5 in every state except California, which has banned all transgenic fish except in biomedical laboratories that can enssure the fish will not escape into the wild.
But the Food and Drug Administration said it had no concerns about the zebra fish, which is infused with a red fluorescent gene of a sea anemone, so that it seems to glow red under ultraviolet light.
“Because tropical aquarium fish are not used for food purposes, they pose no threat to the food supply,” the FDA said in a terse statement.
“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,” the FDA said. “In absence of a clear risk to the public health, the FDA finds no reason to regulate these particular fish.”
The decision is a change of course for the agency, which more than a dozen years ago asserted that its Center for Veterinary Medicine had jurisdiction over genetically altered animals. It is currently evaluating the safety of an Atlantic salmon with designer genes to make it grow five times as fast as its natural cousins.
FDA Deputy Commissioner Lester M. Crawford told The Times this year that the agency’s Center for Veterinary Medicine, would assert authority over the sale of all transgenic animals, including pet fish, under the U.S. Food, Drug and Cosmetic Act.
Some ecologists, conservationists and food-safety groups warn that the sale of this fish without rigorous scrutiny sets a worrisome precedent.
But Alan Blake, chief executive of Yorktown Technologies of Austin, Texas, the company marketing the GloFish, is delighted with the decision and said he plans to return to the California Fish and Game Commission in February to try again to win approval to sell the fish in the state.
The commissioners “cited ethical considerations in turning us down,” Blake said. “We will be citing leading bioethicists from around the country to help us support the ethical basis for the sale of these fish.”
