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GloFish draw suit

Watchdog groups want FDA to regulate first genetically modified pet in US

By | January 7, 2004

The first genetically modified (GM) pets sold in the United States, fluorescent red zebrafish called GloFish, are the focus of a lawsuit against the government from environmental and food safety groups seeking federal regulation of the animals. A coalition led by the Center for Food Safety, a national watchdog group in Washington, DC, plans to file suit this week in a federal district court against the Food and Drug Administration (FDA) for not regulating GloFish.

“It's clear this sets a precedent for genetically engineered animals. It opens the dams to a whole host of nonfood genetically engineered organisms. That's unacceptable to us and runs counter to things the National Academy of Sciences and other scientific review boards have said, particularly when it comes to mobile GM organisms like fish and insects,” Joseph Mendelson, the Center for Food Safety's legal director, told The Scientist.

Zebrafish (Danio rerio), native to the Ganges River in India, are normally striped black and grey and are commonplace both in labs and as pets. Scientists at the National University of Singapore engineered the fish with the gene for red fluorescent protein from sea anemones and coral to detect water pollution, initially injecting the gene into one- or two-cell embryos before they hatched, although GloFish now come from stable lines bred from the original experimental animals. Research continues on developing zebrafish that selectively fluoresce when exposed to contaminants such as estrogen or heavy metals.

The FDA, which holds jurisdiction over the commercial development of GM animals, announced in December that it found no reason to regulate these pets. “Because tropical aquarium fish are not used for food purposes, they pose no threat to the food supply. There is no evidence that these genetically engineered zebra danio fish pose any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States,” the FDA stated. By contrast, a modified “super salmon” that its promoters hope can be used as food has been under review by the FDA for several years. The FDA says that it will provide such oversight, for the time being, on a case-by-case basis.

Alan Blake, chief executive officer of GloFish manufacturer Yorktown Technologies, has told other media outlets that he checked with the Environmental Protection Agency, the US Fish and Wildlife Service, the Department of Agriculture, and the FDA, and was told that they had no regulatory interest. Blake declined requests to be interviewed by The Scientist.

The FDA learned of the planned introduction of the GloFish sometime in October, said John C. Matheson, senior regulatory review scientist at the FDA's Center for Veterinary Medicine. “I think folks are continuing to consider what's the best way,” Matheson told The Scientist the day after the statement was released. “We would have liked to have heard from [Alan Blake] sooner, but I'm not sure there are any legal obligations on him.”

Yorktown Technologies announced that the GloFish would go on sale in January. The fish were 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 that the FDA intervene to forestall the GloFish's retail debut, pending a safety review. They pointed out that Singapore and Japan had already halted sales of fluorescing zebrafish and that many similar new bioengineered products are on the horizon. “The floodgates are yours to close,” their letter stated.

On December 4, California's fish and game commission voted to ban GloFish sales there, citing ethical concerns about genetic engineering for trivial uses. Florida's Department of Agriculture has formed a task force to address future such genetically altered species, but did not ban the sales of GloFish.

Researchers consulted by Yorktown Technologies and independently by the California Department of Fish and Game contended the GloFish pose no greater risk to the environment than wildtype zebrafish. The tropical fish do not survive in nontropical environments. The researchers added the fish's fluorescence burdens the fish metabolically and in avoiding predators, and in lab tests with rats, the fluorescent proteins appeared nontoxic.

“Yorktown Technologies stands by that these fish are safe for the environment. They were originally developed to protect the environment,” a spokesperson for the company said. “The distributors have said there's unprecedented consumer demand.”

Citing the precedent GloFish could set, Mendelson noted that a number of ornamental fish can also be food fish and that the escape of GM ornamental food fish could pose a problem to public and environmental health. “There's a chance here organisms can proliferate without any safety monitoring,” Mendelson said. “That's an abdication of what FDA's role is. They've frankly punted on this GloFish issue, and the ramifications are going to be significant. That's why we've to go stop it.”

GM fluorescent pet fish first went on sale in July in Taiwan and elsewhere in Asia, developed at National Taiwan University with fluorescent proteins from jellyfish and corals and sold by aquarium company Taikong.

Not all concerns about the GloFish center on their potential environmental impact. Petsmart, the largest pet supply chain in the United States, decided not to sell GloFish, citing concerns about the long-term effects of genetic engineering on the fish themselves. “We're going to continue to study how the fish are produced. Once we understand more, we will evaluate our position on whether to sell or not,” Petsmart spokesperson Andrea Davis said.

The suggested retail price of GloFish is $5. Green and yellow fish should become available later this year, according to a Yorktown spokesperson.

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