The (US) Food and Drug Administration is seriously considering whether to approve the first genetically engineered animal that people would eat — salmon that can grow at twice the normal rate. The salmon’s approval would help open a path for companies and academic scientists developing other genetically engineered animals, like cattle resistant to mad cow disease or pigs that could supply healthier bacon. Next in line behind the salmon for possible approval would probably be the “enviropig,” developed at a Canadian university, which has less phosphorus pollution in its manure.
The salmon was developed by a company called AquaBounty Technologies and would be raised in fish farms. It is an Atlantic salmon that contains a growth hormone gene from a Chinook salmon as well as a genetic on-switch from the ocean pout, a distant relative of the salmon. Normally, salmon do not make growth hormone in cold weather. But the pout’s on-switch keeps production of the hormone going year round. The result is salmon that can grow to market size in 16 to 18 months instead of three years, though the company says the modified salmon will not end up any bigger than a conventional fish.

Under a policy announced in 2008, the F.D.A. is regulating genetically engineered animals as if they were veterinary drugs and using the rules for those drugs. And applications for approval of new drugs must be kept confidential by the agency.
Critics say the drug evaluation process does not allow full assessment of the possible environmental impacts of genetically altered animals and also blocks public input. Some of these government officials and executives said that F.D.A. officials had discussed internally whether the salmon could be labeled to give consumers the choice of avoiding them. The government has in the past opposed mandatory labeling of foods from genetically engineered crops and animals merely because genetic engineering was used. Foods must be labeled, it says, only if they are different in their nutritional properties or other characteristics. Virtually all Atlantic salmon now comes from fish farms, not the wild.

The F.D.A. must also decide on the environmental risks from the salmon. Some experts have speculated that fast-growing fish could out-compete wild fish for food or mates. Mr. Stotish said the salmon would be grown only in inland tanks or other contained facilities, not in ocean pens where they might escape into the wild. And the fish would all be female and sterile, making it impossible for them to mate.







