- The Washington Times - Saturday, February 1, 2003

Bioengineered fish create hopes of abundant food and medical benefits, but also bring environmental risks, experts said yesterday at a Capitol Hill forum.

Scientists have altered the genes of the fish to grow more quickly so they can be harvested and used for food. However, the Food and Drug Administration is examining whether they could mix with natural populations of fish, wipe out their habitats and permanently alter other species through interbreeding.

"We all agree these are questions that must be answered," said Elliot Entis, president of Aqua Bounty Farms, a Waltham, Mass., biotechnology company.

The company is developing genetically modified salmon, trout and tilapia eggs to sell to industry. The salmon, for example, can reach maturity in three months, compared with one year for salmon with naturally occurring genes.

In January, the Pew Initiative on Food and Technology warned against developing genetically modified fish before the environmental hazards are better understood and controlled. The Pew Initiative is a nonprofit biotechnology research organization that hosted the Capitol Hill forum yesterday.

A study released by the group said government regulators lack expertise and proper procedural rules to assess the risks of genetically modified fish.

"Regulators will increasingly have to stretch their authority to make old laws and regulations address the evolving next wave of products," said Michael Rodemeyer, the Pew Initiative's executive director. "We seem to be treading in uncharted legal waters."

Bioengineered fish are regulated under FDA rules developed before scientists introduced genetic engineering.

FDA officials say their current regulatory scheme is adequate for bioengineering. Genetic modification changes the structure and function of animal physiology, which is essentially the same as a drug. As a result, it gets regulatory review similar to a new drug.

Applicants for FDA approval must prove their genetic modifications would not harm other animals or the environment.

Aqua Bounty Farms' application for genetically modified Atlantic salmon is pending before the FDA. The company plans to submit an environmental risk assessment in the spring.

The Pew Initiative report said if the FDA institutes better review procedures, the benefits of genetically modified fish outweigh the risks.

An altered form of tilapia could be a source of Factor VII, a compound used to clot human blood for hemophiliacs. Fish also could be made more disease-resistant to increase their supplies for the commercial market. Shrimp could be developed that do not prompt allergic reactions in humans.

The salmon being developed by Aqua Bounty Farms are leaner and could be produced in supplies great enough to bring down the cost of the fish on world markets, Mr. Entis said. The company plans to develop sterile female salmon to avoid the risk they might interbreed with natural salmon if they escape from their ocean pens.

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