GloFish zoom to market
Genetic engineering promises a long line of improvements to animals - from fish that glow to mosquitoes without disease - but are federal regulators keeping a watchful eye?
As far as anyone can tell, the biggest threat from the world's first transgenic pet might be that it keeps a few goldfish awake at night.Skip to next paragraph
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But for opponents of transforming animals through bioengineering, the red glow emanating from the new GloFish might as well be a five-alarm fire.
Because the US government quickly agreed the fish was safe, concern is spreading that regulatory oversight of transgenic animals may be flawed.
A long line of genetically modified animals are under study: flea-resistant dogs, cats with nonallergenic fur, and designer mosquitoes that could outbreed the current pests but would be incapable of carrying diseases such as malaria. Thus, the tiny and innocuous GloFish has plunged the scientific and regulatory communities into murky waters.
"All the experts I've talked to don't have concerns about this particular fish, but it is the precedent for what else is coming; and what are the rules by which those fish or animals are going to be judged?" asks Michael Rodemeyer, director of the Pew Initiative on Food and Biotechnology in Washington. "The question is, we think they're safe, but how do we really know unless somebody has looked at some data and made a decision about that?"
Some officials aren't ready to offer their blessing. On Dec. 4, the California Fish and Game Commission banned the sale of GloFish. Other states are studying whether to ban or regulate these and other transgenic fish. While glowing mice, insects, and rabbits have been bred in laboratories, GloFish represent the first transgenic animals that Americans can take home as pets.
But in a brief statement Dec. 9, the Food and Drug Administration (FDA) said it would not regulate GloFish because they posed no threat to the food supply or "any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States."
Consumer and environmental watchdog groups have reacted with alarm. Last week, the Center for Technology Assessment and the Center for Food Safety filed suit seeking a court order to stop the sale of GloFish pending federal approval.
A report issued Tuesday by the National Research Council also raises concerns about the release of bioengineered animals into the wild. It calls for new research to identify more clearly the ecological risks of genetically modified organisms, including plants, animals, and microbes. It also cites the need for better confinement through isolation and other means, such as sterilization.
"The evaluation of whether and how to confine cannot be an afterthought in the development of a transgenic organism," the report warns. "Safety must be a primary goal from the start of any project."
Genetic scientists agree that it's unlikely GloFish themselves pose a threat, since they wouldn't flourish in the wild.
The fish were created by scientists at the University of Singapore who injected a sea coral gene for red fluorescence into zebrafish embryos. The fish were intended to act as environmental markers, glowing only when they encountered ocean pollutants. But the fish's glow turned out to be always "turned on," quashing that idea.
The GloFish for sale in American pet stores, distributed by Yorktown Technologies of Austin, Texas, are descendants of these genetically altered fish, which continue to express red fluorescence. (They shine most intensely under black light.)
As regulations now stand, the FDA bears most of the responsibility for regulating transgenic animals. In the past, the agency has said that all genetically altered creatures constitute "new drugs" and thus would fall under its review. The FDA's inattention to the GloFish seems to suggest a change in policy.
"The responsibilities of federal agencies for regulating animal biotechnology are unclear," concludes a 2002 report from the National Academies of Science, which also noted "a concern about the legal and technical capacity of the [federal] agencies to address potential hazards, particularly in the environmental area."
A number of agencies, including the US Fish & Wildlife Service, the Army Corps of Engineers, the Environmental Protection Agency, and the US Department of Agriculture could play a role in regulating transgenic animals.
After all, says Joseph Mendelson, legal director of the Center for Food Safety, the FDA is not the expert on something like the dangers of transgenic salmon escaping from a net pen.