In a step that may move genetically engineered meat and fish closer to the American dinner table, an FDA advisory committee will vote Monday on whether to approve preliminary findings that a modified salmon is as safe as an ordinary salmon.
The vote is not binding on the FDA, but approval would lend powerful support for a final decision by the agency charged with protecting the nation's food and drug supplies. The fish, a North Atlantic salmon developed by AquaBounty Technologies Inc. would be the country's first genetically engineered food animal.
It grows to market size in half the time of other salmon and consumes 25 percent less feed in the process, according to the company, which is based in Waltham, Mass.
The FDA will hold a separate hearing on what, if any, labeling should be required if the fish is approved. The FDA says it does not have the power to mandate labeling that describes how a food was made, only the content variation that results from a different production process.
But because genetic engineering is an issue that raises ethical and medical as well as marketing concerns, loud arguments are expected for an exception to FDA past practice.
Earlier this month, the FDA released a preliminary report that the salmon "is as safe as food from conventional Atlantic salmon" and unlikely to harm the environment.
Action on the AquaBounty salmon will be closely watched internationally because fish farming is a global industry and the agency's decisions tend to influence other nations' regulatory bodies.
In addition, FDA approval is expected to be sought for several other genetically engineered animals, including the "enviropig," developed by Canada's University of Guelph, which produces more environmentally friendly manure than normal pigs.
The AquaAdvantage salmon is produced by taking a portion of the gene that protects an eel-like fish called an ocean pout against freezing, transplanting it into the growth gene of a Chinook salmon and transferring the blended genetic material into the fertilized eggs of a North Atlantic salmon.
The resulting fish grows during the summer as well as during the winter months, unlike an ordinary salmon.
The FDA's apparent readiness to approve the AquaBounty salmon has inflamed a coalition of consumer, environmental, animal welfare and fishing groups, who have accused the agency of basing its judgment on data compiled from small samples supplied by the company, rushing the public portion of the review process and disclosing insufficient information about the fish.
The FDA does not have an approval process designed specifically for genetically engineered animals and is evaluating the salmon under the process used for new veterinary drugs. That means that much of the data provided to FDA to demonstrate the safety of the fish is considered a trade secret.
The process doesn't allow enough public participation, doesn't give the FDA enough leeway to consider environmental factors and doesn't give the agency enough power to withdraw the salmon from the market if something should go wrong, said Greg Jaffe, director of the Biotechnology Project for the Center for Science in the Public Interest and a member of the FDA advisory committee that will evaluate the agency's findings.
An FDA spokeswoman defended the agency's handling of the review, saying that "overall, this is the most transparent manner ever used for a new animal drug application."
AquaBounty said its fish will be sterile and will be grown in contained systems so there is virtually no chance they will escape and breed with wild salmon.
Critics say that no sterilization system is perfect, farmed fish invariably escape and the impact of a genetically engineered salmon on wild stocks is unknown.
Opponents also are expected to question the fish's slightly higher levels of a hormone, which has been linked to higher risks of cancer in some studies.
In addition, there is some evidence in AquaBounty's data that its fish might be more likely to trigger allergic reactions, though drawing definite conclusions is difficult because of small sample sizes, said Michael Hansen, senior scientist for the Consumers Union.
AquaBounty cofounder Elliot Entis said he welcomes a debate on the scientific merits of his firm's application, but he characterized some criticism as "misuse of information for ideological purposes."