Gene-Altered Fish Closer to Approval


The U.S. has moved closer to approving a laboratory-tweaked salmon that grows twice as fast as conventional farmed fish and would become the first genetically modified animal to appear on American dinner plates.

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The gene-altered salmon faces opposition from activists such as these in Washington last week.



An FDA advisory committee discussed Monday whether the fish was safe to eat and whether it posed any threat to the environment. The meeting ended without any decision about the fish. But in some ways, the FDA has already drawn its conclusions: In the run-up to the meeting, the FDA posted an analysis online that concluded the genetically altered version was as safe to eat as traditional Atlantic salmon, and posed little risk to the environment.

The AquAdvantage Atlantic salmon contains a growth hormone gene from the Chinook salmon, which accelerates its development in the first year. It also contains a fragment of DNA from the eel-like ocean pout species, which helps to switch on the Chinook gene. The altered fish stops growing when it reaches normal size.

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Ron Stotish, chief executive officer of AquaBounty, the company that applied with the FDA to market genetically modified salmon.



In its analysis, the FDA said the modified fish was chemically and biologically no different from a conventional Atlantic salmon. It offers a commercial advantage because it can reach market weight in 1.5 years to two years, about half the time required for a regular Atlantic salmon.

"There’s an opportunity here to re-establish a domestic salmon industry with land-based aquaculture," said Ronald Stotish, president and chief executive officer of the fish’s developer, AquaBounty Technologies Inc. of Waltham, Mass., who attended the FDA meeting. Out of some 1.5 million tons of Atlantic salmon produced globally each year, the U.S. consumes about 450,000 tons, almost all of it imported, according to Mr. Stotish.

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But Jaydee Hanson, senior policy analyst at the Center for Food Safety, an advocacy group in Washington, D.C., that is campaigning against the salmon, said some of the safety studies were based on sample sizes that were too small. Several of the key studies were based on sample sizes of about 30 fish, while others had slightly more.

"A minimum of 100 fish should have been required," said Mr. Hanson, who spoke at the meeting. "The data isn’t enough—the FDA should ask for more."

Mr. Stotish of AquaBounty defended the test data as sufficient. But during Monday’s meeting, several panelists expressed concerns about the data, though they said there was no reason to believe the salmon wasn’t safe.

The fish story is part of a larger global trend. Driven by a growing population, higher food prices and the lack of clear-cut evidence that genetically modified food is harmful to human health, there has been a growing global acceptance of products once derided as "Frankenfoods." That’s especially true in developing countries.

Genetically altering food can offer several benefits, scientists say. A crop can be engineered to provide larger yields, to be more tolerant of pesticides, or to better resist drought or pests. Sometimes, they may be cheaper to produce. Many countries are racing to take advantage of genetically modified (or GM) food.

In a significant but little-noticed move last December, China declared that certain strains of GM rice and corn were safe to produce and consume.

That step endorsed the use of biotechnology for the planet’s most important food crop, rice, which feeds half of humanity, and the biggest animal-feed crop, corn. While further field trials are needed, industry experts expect Chinese GM rice and corn to be produced in two to three years.

South Africa grows GM corn. Brazil and Pakistan grow GM soybeans and corn. India has been growing GM cotton for several years. A recent push to commercialize India’s first GM food crop—a pest-resistant eggplant—was recently put on hold on safety grounds.

In 2009, global acreage used to grow GM crops rose 6.8% to 330 million acres from 309 million acres in 2008, according to the International Service for the Acquisition of Agri-Biotech Applications, a GM industry group. Almost half of the global acreage was planted in developing countries.

Farmers world-wide pay roughly $9 billion annually for GM seed, according to seed-industry estimates. There are several developers of genetically modified crops, of which Monsanto Co. of St. Louis is the largest.

Europe has long been extremely cautious about planting GM crops. But in late July, the European Commission approved the import of six GM corn varieties for use in food and animal feed, though not for cultivation in Europe itself. In the same month, the commission also proposed new rules allowing each of its member states to choose whether or not to grow an approved GM crop within its borders. So far, the only EU-approved GM crop is a high-starch potato engineered for industrial use.

On the animal front, scientists at the University of Guelph in Canada have created a genetically modified pig that can better digest and process phosphorus, reducing production costs. The animals are cheaper to feed because they don’t need phosphorus supplements—a chemical vital to a pig’s diet but expensive for farmers to buy. The pig’s developers also claim that because animals release 30% to 70% less phosphorus in their waste, they’re good for the environment. Swine waste is a significant source of pollution.

Enviropig, which some critics have already dubbed "Frankenswine," is still under review by two Canadian regulatory agencies, Health Canada and the Canadian Food Inspection Agency. A few months ago, another agency, Environment Canada, approved production of the animals as long as they are strictly contained. The FDA and Canadian authorities are still reviewing data about the pig to see if it’s safe to eat.

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In the U.S., GM crops were introduced in 1996, and are a regular part of the food supply, including corn, soybeans and sugar. "If you eat any of those products, you have an 85% or greater possibility that you are eating a GM food," said Marion Nestle, professor of nutrition at New York University.

AquaBounty created its first genetically altered salmon in 1989, and submitted its initial set of data to the FDA in 1995. So far, it has accumulated data from 10 generations of the animals. The company has far-flung operations—it is based in the U.S., its stock trades in London and it has fisheries in Canada and Panama.

Fish grown from the engineered eggs are all female and sterile. To prevent an accidental escape into the sea, AquaBounty wants the FDA to approve the fish only for inland fisheries.

In its scientific assessment, the FDA said that the genetically altered salmon posed "no additional allergenic risk than control Atlantic salmon."

Still, worries abound. Some 20 environmental and consumer groups have submitted joint comments to the FDA panel identifying what they believed were flaws in how AquaBounty sterilizes and isolates the modified fish, and the high volume of antibiotics that may be required to produce them in factory farms.

AquaBounty’s Mr. Stotish said, "That’s preposterous and totally designed to frighten people. The data doesn’t support their accusation at all."

On Tuesday, the FDA will hold a hearing on how the fish and products made from it should be labeled for consumers. It’s not clear when the FDA will make a final decision about the fish.

If approved, the fish likely won’t show up in the nation’s food supply for two or three years.


Write to Gautam Naik at

Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved

Gene-Altered Fish Closer to Approval

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