GloFish zoom to market

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.

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.

"You've got to look at bringing in the other agencies here who have the expertise in what the environmental issues are," he says. "With this GloFish issue, the FDA, primarily, and the other agencies are essentially washing their hands of the issue, and that sets a horrible precedent."

The problem of hazy jurisdiction stems from the inability of Congress to pass comprehensive legislation in the 1980s, says Eric Hallerman, a professor of fisheries and wildlife science at Virginia Tech University in Blacksburg, Va.

Instead, agencies were forced to try to stretch existing laws to cover transgenic animals. Genetically altered animals that produced food or medicine fell under the FDA. But the approach left "holes" in the regulatory system, Professor Hallerman says, including the question of who would regulate "ornamental" animals: household pets. "Regulators were caught unaware by [the GloFish]," he says, "and it went forward and went commercial very quickly."

Serious scientific and ethical concerns surround transgenic animals, including questions of whether they can safely be part of the food chain and whether genetic manipulations are fair to the animals themselves.

But the greatest worries are environmental: What potential damage might transgenic species do if released in the wild? The "Trojan gene" theory, for example, proposes that a transgenic fish altered to grow faster and larger might outcompete its wild relatives for mates. But what if it then proved to produce weak, less fertile offspring? Such a combination of new qualities could weaken a species in the wild or even bring it to extinction.

Scientific interest in transgenic animals remains high because along with their risks they offer potentially huge rewards. Cows, sheep, goats, swine, fish, and insects already have been genetically altered to grow faster and larger for food production or to produce beneficial products like pharmaceuticals or organs for transplant into humans. Transgenic mice have become an important laboratory research tool. One company is producing spider silk in the milk of transgenic goats that is strong enough to be used in making body armor for the military. A patented Enviropig produces manure with much less phosphorus, reducing its adverse effects on the environment.

Looking ahead, researchers are working on a transgenic mosquito bred to not carry diseases such as malaria and dengue fever. It would be released in the wild to spread its genes through existing populations, a potential boon to human health. But before that happened it would be vital to know that no adverse unintended consequences would result.

Some see GloFish as a trivial application of genetic manipulation, not worth any problems it might spawn. Others point out that humans have been altering animals through traditional breeding techniques for thousands of years, sometimes only for pleasure.

"I don't have any problem engineering animals. Ethically, we've answered that," says Art Caplan, chair of the department of medical ethics at the University of Pennsylvania in Philadelphia. "We have sheep and cows and dogs and cats that look like nothing that ever existed in nature."

What would be ethically troublesome, he says, are changes that cause an animal to suffer, such as the hip problems in German Shepherds caused by inbreeding or breathing problems that bulldog breeds develop. If people are going to protest that GloFish are a trivial use of technology, we'd "have to protest all technology," Caplan says. "We're very good at using technology for fun. I'm not against fun. It's fine to make a fish that glows when it doesn't hurt the fish and amuses us."

Some observers say the more work that is done with any kind of transgenic animals, the better we'll be able to understand the implications of genetically manipulating human beings. "It seems frightening to talk about genetically engineering your baby," Caplan says, "but if you had a non-allergenic cat ... that didn't shed or had less dander, that makes genetic engineering seem less frightening."

Part of making people comfortable with transgenic animals lies in letting them know that someone is keeping a close eye on their development.

"If you don't want to scare the public, you'd better have an agency responsible, and you'd better have clear-cut rules, and you'd better mandate that they be followed," he says. "We don't have that."