US drugs watchdog opens hearing on use of 'frankenfish'

Tinker with the genetics of salmon and maybe you create a revolutionary new food source that could help the environment and feed the hungry.

Or perhaps you are creating what some say is an untested "frankenfish" that could cause unknown allergic reactions and the eventual decimation of the wild salmon population.

The US Food and Drug Administration heard both arguments yesterday as it began hearings on whether to approve the marketing of the genetically engineered fish, which would be the first such animal approved for human consumption in the world. The agency has already said the salmon, which grows twice as fast as conventional salmon, is as safe to eat as the traditional variety.

Opening the session, Ron Stotish, chief executive of AquaBounty, said his company's modified fish are environmentally sustainable and safe to eat.

AquaBounty submitted its first application for FDA approval in 1995, but the agency decided not until two years ago to consider applications for genetically engineered animals - a move seen as a breakthrough by the biotechnology industry.

Genetic engineering is widely used for crops in the US, but the government until now has not considered allowing the consumption of modified animals.

Genetically engineered - or GE - animals are not clones, which the FDA has said are safe to eat. Clones are copies of an animal. With GE animals, their DNA has been altered to produce a desirable characteristic.

In the case of the salmon, AquaBounty has added a growth hormone from a Chinook salmon to an Atlantic salmon that allows the fish to produce their growth hormone all year long. The engineers were able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an on switch for the hormone, according to the company. Conventional salmon only produce the growth hormone some of the time.

In documents released ahead of the hearing, the FDA said there were no biologically relevant differences between the engineered salmon and conventional salmon, and there is a reasonable certainty of no harm from its consumption.

Critics have two main concerns: The safety of the food to humans and the salmon's effect on the environment.

As the altered fish has never been eaten before, they say, it could include dangerous allergens, especially because seafood is highly allergenic. They also worry the fish will escape and intermingle with the wild salmon population, which is already endangered.They would grow fast and consume more food to the detriment of the conventional wild salmon, the critics fear.

"It is outrageous to keep this vital information secret," said Wenonah Hauter, director of the advocacy group Food & Water Watch."Consumers have a right to know what the FDA is trying to allow into our food supply."

Mr Stotish argued the company has addressed the concerns, and his product has come under more scrutiny than most food.

The company has several safeguards in place to allay concerns. All the fish would be bred female and sterile, though a small percentage may be able to breed. They would be bred in confined pools where the potential for escape would be very low.

BACKGROUND

One major area of concern is, if the salmon is approved, whether US consumers will know when they are buying it.

Current FDA rules only call for special labels for altered food when there is a "material difference" in the product's end result. The company and FDA staff both say tests show the fish's composition appears similar to normal fish.

Special package labelling to note AquaAdvantage salmon is altered, "just causes confusion for the consumers," said David Edwards, of the the Biotechnology Industry Organisation.