Washington

Approval for the commercial farming of transgenic salmon in the United States remains at least 18 months off, say officials at Aqua Bounty Farms in Waltham, Massachusetts, the only company that has filed for approval to produce them.

The progress of the application, made by Aqua Bounty Farms in November 1996, has been watched avidly by advocates of transgenic technology — including researchers hoping to develop their own genetically modified fish — who had hoped that the Food and Drug Administration (FDA) would have given its approval by now (see Nature 406, 10–12; 2000).

Critics of the technology point to the unknown risks posed by a possible escape of the fish from their farms, perhaps leading to competition with wild fish for food, the introduction of transgenes into wild fish, and even possible collapse of wild fish populations.

Joseph McGonigle, vice-president of Aqua Bounty Farms, says that he doesn't expect the FDA to approve the application until late 2004. The company plans to submit a second application, for transgenic trout, in about a year's time.

McGonigle says that the delay is placing the company under financial strain. “Money's an issue now,” he says. “We've been living on venture capital for years.”

But a report issued last week by the non-profit Pew Initiative on Food and Biotechnology questioned the FDA's ability to regulate transgenic fish properly. It says that the FDA lacks the expertise to evaluate environmental risks. The report also calls for greater transparency and public involvement in the review process.

Aqua Bounty's Atlantic salmon carry a gene construct of the growth-hormone gene from Pacific chinook salmon, and a promoter sequence from the ocean pout for the production of antifreeze proteins. They grow twice as fast as most farmed salmon but consume less food. The company is working with the Harvard Center for Risk Analysis to perform an environmental-impact assessment, which it will use to support its application.

Meanwhile, Chinese researchers have been working with fast-growing transgenic carp since the late 1980s, and Cuba is considering commercialization of tilapia that were first bred there in 1993. The Cuban researchers say it will be three years before they know the regulatory fate of their tilapia.

Mario Estrada, leader of the aquatic-organism project at the Center for Genetic Engineering and Biotechnology in Havana, says that most of the food-safety studies are done, including an experiment in which tilapia were eaten by volunteers.

Researchers elsewhere are working with transgenes that will resist bacterial or viral infection. “Disease is one of the biggest issues in raising fish in aquaculture,” says Bill Muir, a professor of genetics at Purdue University in West Lafayette, Indiana.

→ http://pewagbiotech.org/research/fish