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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?

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"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."

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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.

Ethics of bioengineering

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."