<p>Figure 1</p>

Walter Courtenay, a 35-year veteran of government and academic science, looks into his office aquarium and hopes he isn't seeing the future. University of Miami molecular geneticist Patrick Gibbs looks into his, and sees a mystery. Both researchers are watching a merry-looking breed whose trademark name is Glofish – America's first genetically engineered pet.

Courtenay, a USGS research fishery biologist and specialist in invasive species, says the three vivid little Glofish that he bought in a Gainesville, Fla., pet store are likely to be environmentally benign, an opinion shared by many researchers. He, Gibbs, and others voice concern, however, over the precedent set by what they see as the federal government's hands-off treatment. "I don't want to see any more of these. I hope this is the end of it," Courtenay says. "Right now, there is no regulatory process at all."

Gibbs wrote in an E-mail to colleagues:...


California's Fish and Game Commission took a different approach. The commission's staff and consulting scientists, in reviews that were made public, found that the fish posed little threat to the environment. Despite this, the commissioners voted to ban Glofish sales there anyway, citing ethical concerns about genetic engineering for trivial uses.

The Florida Department of Agriculture has convened a task force to examine the environmental impacts of genetically modified (GM) fish, and Michigan's Department of Natural Resources is working on new legislation that would restrict possession and transportation of GM organisms. Michigan has no plan to ban the Glofish, a spokesman says.

The species, normally silver with black stripes, is usually referred to as the zebrafish, a native of the Ganges River region and a common choice for lab research. Genetically modified by adding a gene from sea coral to zebrafish eggs, it becomes the reddish Glofish, which fluoresces under ultraviolet light. The trait is heritable. Yorktown Technologies of Austin, Texas, owns the US license to distribute the fish.

<p>Figure 2</p>


Normal zebrafish eggs are injected with a gene from sea coral which produces the glow seen under ultraviolet light.


Alan Blake, a 26-year-old entrepreneur and the CEO of Yorktown Technologies, imported the fish to the United States. He declined to be interviewed but noted in a press release that several top fish geneticists have affirmed the environmental safety of the fish. He also has said in news reports that he checked with the Environmental Protection Agency, the US Fish and Wildlife Service, the Department of Agriculture, and the Food and Drug Administration; he says all four agencies told him that they had no regulatory interest.

FDA spokesman John C. Matheson says the agency was blind-sided by a fast-moving technology and its own uncertainty, after more than a decade of mulling over regulating transgenic animals. He says that in the future, the agency will deal with such novelties on a case-by-case basis until a firmer policy is adopted.

A couple of weeks after the fish became available in pet stores, the FDA issued a one-paragraph statement that concluded: "In the absence of a clear risk to the public health, the FDA finds no reason to regulate these particular fish." The public health responsibility can be more generally interpreted, Matheson says. "I'd read `public health' broadly – that we'd be evaluating [GM animals] individually, based on their potential risk to the public health and the environment."

Some scientists also were caught up in the uncertainties. Two who were recruited to examine the fish's environmental safety say the lack of a formal federal review process surprised them. Their experience forecasts some paradoxes for scientists who are called upon for advice by entrepreneurs, especially if regulatory oversight of genetic engineering wanes in the future.

Bill Muir, a professor of genetics at Purdue University, and fishery science professor Eric Hallerman, who specializes in population genetics and risk assessment at Virginia Polytechnic Institute, volunteered to review data that Blake provided on the Glofish's safety. The two men have no financial ties to the product, and they performed the reviews gratis. The letters are posted on the promotional Web site, http://www.Glofish.com, and also were submitted by Yorktown Technologies to the California Fish and Game Commission as part of the company's application to sell Glofish in that state.

Based on data that Blake provided, Muir concludes in his letter that "one would expect natural selection to eliminate the transgene regardless of where it escaped or was released." Hallerman's letter characterizes the possibility of ecological impacts from escaped Glofish as "remote." Nevertheless, he has other concerns "I think there is a real issue here," Hallerman says. "This Glofish fell right through the cracks of federal oversight." Without federal review, he added, biotechnology "becomes a state issue, and then there's fifty different regulatory regimes."

But both scientists say their letters should not be used to substitute for careful scientific review. "The Glofish really didn't go through any federal review process as far as I understand it," Muir says. "Everything that has an environmental impact should have some sort of regulatory overview. Even children's toys and children's clothes have that – anything that has a potential of moderate risk."

At the time he wrote the letter, Muir says, he thought the FDA intended to regulate transgenic pets. "To be quite frank, I thought they were going to be shut down by the FDA before they got released," he explains. The first hurdle for the Glofish should have been an environmental assessment, to determine whether a full-blown environmental impact review needed to be performed, Hallerman adds. "There should at least have been an application process, a hearing in Washington, and an advisory board weighing in. That can all be done expeditiously in a slam-dunk case like this."

Gibbs has similar concerns. At one point he entered negotiations with Yorktown Technologies to create the Glofish, but they broke off because of disagreements on terms. "I want the regulatory people to look into this thing responsibly and make a decision based upon the facts," his E-mail said.

Not that all the experts agree. Perry Hackett of Discovery Genomics in Minneapolis was also involved in the development of the Glofish project. His response to Gibbs' E-mail accuses Gibbs of "playing on the scientific ignorance of the general population to spoil what should be an interesting example of the power of modern molecular genetics that everyone can understand."

During most of his 35-year career as an aquatic biologist, Courtenay has studied the lifeways of alien fish species let loose in North American waters, including the ways they disrupt ecosystems and devastate native fish populations. He was summoned in 2002 for advice when voracious Asian snakehead fishes escaped from someone's home collection and multiplied in a Maryland pond. They threatened to join carp, swamp eels, nutria, zebra rapa whelks, and dozens of other destructive, invasive species that thrive in the United States.

"The problem with the Glofish is not this one," says Courtenay. "It's what's next. What scares me the most is that if they start modifying fish that turn out to be predators and released into the environment – which people will do, they always release their pets, for some reason or other – it could cause serious problems."

Steve Nash can be reached at snash@richmond.edu.

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