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.