-- the first approval of a genetically engineered animal intended for food. The FDA, after years of review, had deemed food from the AquaAdvantage Salmon safe to eat in 2015 and said there is no biological difference between these salmon and nongenetically engineered salmon.
"But Congress blocked the FDA in 2016 from allowing the fish to be sold in the US until it finalized labeling guidelines to inform consumers the product was genetically engineered. The FDA then went ahead and implemented the import alert."
For your convenience here is the text of that article. (The "all caps" emphasis was in the NYT article online)
By Andrew Pollack
Nov. 19, 2015
Federal regulators on Thursday approved a genetically engineered salmon as fit for consumption, making it the first genetically altered animal to be cleared for American
supermarkets and dinner tables.
The approval by the Food and Drug Administration caps a long struggle for AquaBounty Technologies, a small company that first approached the F.D.A. about approval in the 1990s.
The agency made its initial determination that the fish would be safe to eat and for the environment more than five years ago.
The approval of the salmon has been fiercely opposed by some consumer and environmental groups, which have argued that the safety studies were inadequate and that wild salmonpopulations might be affected if the engineered fish were to escape into the oceans and rivers.
“This unfortunate, historic decision disregards the vast majority of consumers, many independent scientists, numerous members of Congress and salmon growers around the world, who have voiced strong opposition,” Wenonah Hauter, executive director of Food & Water Watch, said in a statement.
WITHIN HOURS OF THE AGENCY’S DECISION ON THURSDAY, ONE CONSUMER ADVOCACY GROUP, THE CENTER FOR FOOD SAFETY, SAID IT AND OTHER
ORGANIZATIONS WOULD FILE A LAWSUIT CHALLENGING THE APPROVAL.
THE AQUADVANTAGE SALMON, AS IT IS KNOWN, IS AN ATLANTIC SALMON THAT HAS BEEN GENETICALLY MODIFIED SO THAT IT GROWS TO MARKET SIZE FASTER THAN A NON-ENGINEERED FARMED SALMON, IN AS LITTLE AS HALF THE TIME.
THE F.D.A. HAS THOROUGHLY ANALYZED AND EVALUATED THE DATA AND INFORMATION SUBMITTED BY AQUABOUNTY REGARDING THE
AQUADVANTAGE SALMON AND DETERMINED THAT THEY HAVE MET THE REGULATORY REQUIREMENTS FOR APPROVAL, INCLUDING THAT FOOD FROM
THE FISH IS SAFE TO EAT,” BERNADETTE DUNHAM, DIRECTOR OF THE AGENCY’S CENTER FOR VETERINARY MEDICINE, SAID IN A STATEMENT.
F.D.A. OFFICIALS SAID ON THURSDAY THAT THE PROCESS TOOK SO LONG BECAUSE IT WAS THE FIRST APPROVAL OF ITS KIND. PEOPLE INVOLVED IN
THE APPLICATION SUSPECT THAT THE OBAMA ADMINISTRATION DELAYED APPROVAL BECAUSE IT WAS WARY OF A POLITICAL BACKLASH.
The officials said the fish would not have to be labeled as being genetically engineered, a policy consistent with its stance on foods made from genetically engineered crops. However, it issued draft guidance as to wording that companies could use to voluntarily label the salmon as
genetically engineered or to label other salmon as not genetically engineered.
However, moving beyond Canada and Panama seems to be the plan, according to a regulatory filing by AquaBounty a year ago. It said at that time that after winning F.D.A. approval it would look to build a hatchery in the United States and expand the one in Canada to sell more eggs to
fish farmers, who would then grow the salmon to market size. AquaBounty said it might also grow salmon from the eggs itself. In addition to the United States, it said it eventually hoped to sell the salmon in Canada, Argentina, Brazil and China.
The approval could help other efforts to develop genetically modified animals. Scientists and biotechnology industry executives have complained that the long, unexplained delay in approving the salmon was a deterrent to the field. Several other attempts to develop genetically engineered animals for consumption, like a pig whose manure would be less
polluting, have fallen by the wayside.
Now, however, there has been a surge of interest in developing new genetically altered farm animals and pets because new techniques, including one known as Crispr-Cas9, allow scientists to edit animal genomes rather than add genes from other species.
That has made it far easier to create altered animals. Scientists in China, for instance, recently created goats with more muscle and longer hair.
Researchers in Scotland used gene editing to create pigs resistant to African swine fever. It is not yet clear whether animals created this way would fall under F.D.A. regulation.
The AquAdvantage salmon contains a growth hormone gene from the Chinook salmon and a genetic switch from the ocean pout, an eel-like creature, that keeps the transplanted gene continuously active, whereas the salmon’s own growth hormone gene is active only parts of the year. The company has said the fish can grow to market weight in 18 to 20 months, compared with 28 to 36 months for conventionally farmed salmon.
Opponents of the fish say that if the bigger fish were to escape, they could outcompete wild salmon for food or mates. Among the opponents have been members of Alaska’s congressional delegation, who say they are worried about the effects on the image and health of wild salmon.
A version of this article appears in print on Nov. 19, 2015, on Page A1 of the New York edition with the headline: Genetically Engineered Salmon Declared Ready for U.S. Plates