Swimming under the radar

When aquatic biologist Walter Courtenay looks into his aquarium these days, he hopes he isn't seeing the future.

Darting among the bubbles are a handful of minnow-sized GloFish -- America's first genetically engineered pet -- which he bought in a Gainesville, Fla., store in late November and which went on sale in Boston-area tropical fish outlets this month.

The merry-looking, human-created strain of zebrafish suddenly appeared in stores a couple of weeks before a taken-by-surprise US Food and Drug Administration declared that no formal review for environmental safety would be needed.

The FDA decision reversed earlier public statements that the agency would provide regulatory review for all introductions of genetically modified pets.

GloFish haven't made much of a splash in Boston yet, retailers say. They are available at the Fish Nook in Acton, but few customers have asked for them because they have not been heavily advertised, said Robyn Bright, whose father owns the store.

At Skipton's Discount Pet Center in Boston, fish department manager Leo Labonte said GloFish don't really glow as much as promotional pictures led him to believe. They sell for $8, as opposed to $1.50 for normal zebrafish. "It's a fad. They come and go. Iguanas, hedgehogs, that sort of thing. It'll be gone in a month," he said.

The zebrafish, normally silver with black stripes, is a native of the Ganges River region. Modified with the genes of a type of coral, it becomes the patented reddish GloFish, which fluoresces under ultraviolet light. Yorktown Technologies of Austin, Texas, owns the US license to distribute the fish.

There is little concern among scientists that escaped GloFish might multiply and derail native ecosystems, because US waters are generally too cold. Instead, Courtenay and some other researchers voice distress over the precedent set by what they see as the federal government's confusing, laissez-faire treatment of a genetic novelty for sale to the public. Yorktown Technologies CEO Alan Blake declined to be interviewed.

California's fish and game commission voted early this month to ban GloFish sales in that state. Commissioners said they had ethical misgivings about genetically engineering fish for trivial uses. No other states have indicated that they will regulate genetically modified fish.

An FDA spokesman said in an interview that the agency was blindsided by a fast-moving technology and its own uncertainty -- after more than a decade of mulling -- over what to do about regulating transgenic animals.

The FDA only learned of the planned introduction of the GloFish sometime in October, spokesman John C. Matheson said. Yorktown Technologies then announced that the GloFish would go on sale in January. The fish was actually available in Florida retail outlets in late November, and in other states soon after.

On the brink of those first sales, the Center for Food Safety, the Sierra Club, Consumers' Union, Greenpeace, and other environmental groups demanded a federal environmental safety review for all genetically modified animals. "The floodgates are yours to close," their letter stated.

A couple of weeks after the fish went on sale, 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." Matheson said that the phrase "public health" should be interpreted broadly, to include environmental health. The agency will decide on a case-by-case basis until it develops a formal policy on genetically engineered animals, he said.

California's review process included assessments by several state and university scientists whose identities and opinions were part of the public record. The FDA review was quite different. Matheson said it consisted of informal discussions with staff members of several federal agencies. No written records were kept, no reports were issued, and the names of the conferees were withheld.

Some scientists were also caught up in the FDA's uncertainties. Yorktown's Blake asked at least five prominent researchers to write letters vouching for the environmental safety of the GloFish. The letters were among those posted on the GloFish website as reassurance for the public that the product is environmentally safe.

Two of the letter writers have financial ties to the GloFish project that are not disclosed in their letters. Two others said in interviews that despite their confidence in its safety, the new fish should have triggered a formal, independent federal regulatory review before going on sale -- and they were taken by surprise when it didn't.

Bill Muir, a professor of genetics at Purdue, and fishery science professor Eric Hallerman, who specializes in population genetics and risk assessment at Virginia Tech, both volunteered to review data on the GloFish's safety. The two scientists have no financial ties to the product.

Muir's letter concludes that the added genetic material would disappear among fish in a natural setting. Hallerman characterized the possibility of ecological impacts from escaped GloFish as "remote."

But both scientists are concerned that such letters could 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 said. "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."

The first hurdle for the GloFish should have been an environmental assessment, to determine whether a full-blown environmental impact statement review needed to be performed, Hallerman said.

"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," he said.

During most of his career, Courtenay has studied the lifeways of alien fish species let loose in North American waters, such as nutria and swamp eels, that disrupt ecosystems and devastate native fish populations. He was summoned in 2002 to advise when voracious Asian snakehead fish made it out of someone's home collection to multiply in a Maryland pond.

"The problem with the GloFish is not this one. It's what's next," said Courtenay, a federal research fishery biologist. "What scares me the most is that if they start modifying fish that turn out to be predators and [release them] into the environment -- which people will do, they always release their pets, for some reason or other -- it could cause serious problems."