WASHINGTON -- Federal health regulators say a genetically modified salmon that grows twice as fast as normal is unlikely to harm the environment, clearing the way for the first approval of a scientifically engineered animal for human consumption.
The Food and Drug Administration on Friday released its environmental assessment of the AquaAdvantage salmon, a faster-growing fish which has been subject to a contentious, yearslong debate. The document concludes that the fish "will not have any significant impacts on the quality of the human environment of the United States." Regulators also said that the fish is unlikely to harm populations of natural salmon, a key concern for environmentalists.
The FDA will take comments from the public on its report for 60 days before making it final.
The FDA said more than two years ago that the fish appears to be safe to eat, but the agency had taken no public action since then.
Experts view the release of the environmental report as the final step before approval. If FDA regulators clear the salmon, as expected, it would be the first genetically altered animal approved for food anywhere in the world.
Critics call the modified salmon a "frankenfish." They worry that it could cause human allergies and the eventual decimation of the natural salmon population if it escapes and breeds in the wild. Others believe breeding engineered animals is an ethical issue.
AquaBounty, the Maynard, Mass.-based company behind the fish, has maintained that the fish is safe and that there are several safeguards against environmental problems. The fish would be bred female and sterile, though a very small percentage might still be able to breed. The company said the potential for escape is low. The FDA backed these assertions in documents released in 2010.
Since its founding in 1991, Aquabounty has burned through more than $67 million developing the fast-growing fish. According to its midyear financial report, the company had less than $1.5 million in cash and stock left. It has no other products in development.
In genetically engineered animals, the DNA is altered to produce a desirable trait. The AquaAdvantage salmon has an added growth hormone from the Pacific Chinook salmon that allows it to produce growth hormone all year long. The engineers were able to keep the hormone active by using a gene from an eel-like fish, called an ocean pout, that acts as an "on" switch for the hormone. Typical Atlantic salmon produce the growth hormone for only part of the year.
If the salmon are eventually approved for sale, consumers may not even know they are eating them. According to federal guidelines, the fish would not be labeled as genetically modified if the agency decides it has the same material makeup as conventional salmon. AquaBounty says that AquaAdvantage salmon have the same flavor, texture, color and odor as the conventional fish, and the FDA so far has not shown any signs of disagreeing.