By Jerry Hagstrom
DTN Political Correspondent
WASHINGTON (DTN) -- The Food and Drug Administration on Thursday approved genetically engineered salmon as "safe to eat." But the approval came in the form of a drug approval, and consumer advocates promised to try to stop its commercialization.
"The FDA scientists rigorously evaluated extensive data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law; namely, safety and effectiveness," FDA said in a news release.
"The data demonstrated that the inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor's claim about faster growth."
"In addition, FDA assessed the environmental impacts of approving this application and found that the approval would not have a significant impact on the environment of the United States," the FDA statement continued.
"That's because the multiple containment measures the company will use in the land-based facilities in Panama and Canada make it extremely unlikely that the fish could escape and establish themselves in the wild."
The AquAdvantage salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama, FDA said, and the approval does not allow the fish to be bred or raised in the United States.
But the FDA noted that it is approving AquAdvantage salmon as an "animal drug application."
FDA noted that the salmon "contains an rDNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter (a sequence of DNA that turns on the expression of a gene) from ocean pout (another type of fish). This allows the salmon to grow to market size faster."
The fact that the approval of the fish is technically the approval of a drug application may make it difficult to market the salmon to consumers, according to some consumer advocates, although the immediate battle is over whether the genetically engineered salmon is safe to eat and whether the fish could escape and damage the environment.
Sen. Lisa Murkowski, R-Alaska, told DTN in an email, "I am in shock today at the FDA's abrupt announcement to approve genetically engineered 'salmon' -- what seems to be more science experiment than fish or food."
"I have adamantly opposed the approval of GE salmon, both for the health of Americans and the sustainability of our fisheries, but now that the decision has been made, the next step must be to ensure that Americans know what they are consuming," said Murkowski.
"I have introduced both a bill and provision in the appropriations process to mandate the labeling of 'Frankenfish,' and it is more imperative than ever, after this potentially disastrous decision, to make sure they become law."
Late Thursday afternoon, Murkowski said in a Senate floor speech that the FDA decision is "very troubling" for anyone concerned about "our wild species of salmon, our healthy wild stocks."
Murkowski noted that this would be the first approval of a genetically engineered animal for human consumption "ever."
Food and Water Watch said the FDA decision "disregards AquaBounty's disastrous environmental record, which greatly raises the stakes for an environmentally damaging escape of GMO salmon."
"Canadian researchers found that GMO salmon readily breed with a different species of fish, a potential risk that FDA never addressed in its risk assessment," the group said. "To add insult to injury, this product will be hitting store shelves without labeling, making it impossible for concerned consumers to distinguish GMO from non-GMO salmon."
Wenonah Hauter, executive director of Food and Water Watch, said the group "will be examining all options to stop this controversial and unnecessary GMO fish from reaching the marketplace."
"We urge President [Barack] Obama to overturn FDA's approval and stop GMO salmon from reaching consumers' dinner plates," Hauter said.
The Center for Food Safety announced it will sue FDA to block the approval.
Consumers Union, publishers of Consumer Report, expressed its "deep disappointment" over the approval, and said "it's even more concerning that the FDA chose not to require any form of labeling, making it extremely difficult for consumers to know if the salmon is GE or not."
The Biotechnology Industry Organization (BIO) commended the FDA "for taking this very important step in the right direction for the advancement of animal biotechnology innovation."
"The agency found that AquAdvantage salmon is not materially different from other Atlantic salmon and is just as safe and nutritious as non-GE salmon," BIO said.
"AquAdvantage salmon can be grown in contained facilities close to population centers, thus bringing fresh seafood to consumers with a reduced environmental impact."
"Animal biotechnology can improve livestock to require less feed, produce more protein, and reduce environmental impact, while also providing for enhanced animal health and welfare," added BIO President and CEO Jim Greenwood.
"Other animal biotechnology applications can improve human health through faster discovery of cures, improved medicines and life-saving tissues and organs."
The Information Technology & Innovation Foundation also praised the approval, saying, "The innovative biotechnology involved in genetically engineering salmon promises to bring healthy and affordable food within reach for countless consumers with lower environmental impact than traditional ocean-farmed salmon."
(AG)
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