In a potential blow to the future of the biotech industry, a handful of House lawmakers voted last night to bar the Food and Drug Administration from approving any bioengineered salmon for mass consumption.
A terse amendment offered by Reps. Lynn Woolsey (D-Calif.) and Don Young (R-Alaska) would ban FDA from spending any funds on genetically engineered salmon approvals beginning in the next financial year. Less than a dozen lawmakers voted by voice to attach the amendment to an agriculture spending bill expected to pass the House this week.
The amendment is squarely aimed at preventing the approval of a fast-growing modified salmon developed by AquaBounty Technologies. For years, FDA has considered approving the salmon for limited cultivation in inland tanks, and last fall the agency held public meetings considering the approval, drawing broad public notice. The largely sterile salmon could be the first bioengineered animal approved for human consumption.
"This sort of political gamesmanship undermines the science-based regulatory process," said Ronald Stotish, AquaBounty's CEO. "It is astonishing that Young and the very few representatives present during this vote -- less than the number of fingers on both hands -- would try to game the system in this way."
Young has long been opposed to AquaBounty's salmon, introducing bills last year and this year banning the fish or, if it is approved, requiring mandatory labeling of the salmon as genetically engineered. He has been joined in his fight by a small bipartisan group of Pacific Northwest lawmakers, including Sens. Lisa Murkowski (R-Alaska) and Patty Murray (D-Wash.), among others.
In a statement, Young said he had deep concern about the salmon, which he dubbed "Frankenfish."
"Frankenfish is uncertain and unnecessary," Young said. "Should it receive approval as an animal drug, it clears the path to introduce it into the food supply. My amendment cuts them off before they can get that far. Any approval of genetically modified salmon could seriously threaten wild salmon populations as they grow twice as fast and require much more food."
AquaBounty's salmon has drawn fire from a host of environmental groups, concerned about its potential escape, and also from the salmon farming industry. Should the bioengineered salmon be approved and grown profitably in inland tanks, the fish could undermine traditional ocean-based farms and give AquaBounty a dominant position in the industry.
If FDA approves its petition, AquaBounty would grow its largely sterile salmon at inland fish farms in Canada and Panama for eventual sale in the United States. AquaBounty has proposed layers of confinement for these facilities, and its partners would need to seek FDA approval for expanded cultivation. However, these applications could come without public input and could allow a compounded environmental risk to go unexamined, environmental groups warn.
In recent months, these groups have focused their campaign against the salmon on the state level, pushing for a bill to label the fish in the California Legislature. While the state's Assembly Health Committee approved the bill, it has not yet faced a full vote.
Meanwhile, they have also submitted a formal petition to FDA calling for a full environmental impact statement (EIS) on the fish's potential effects, said George Leonard, director of the aquaculture program at the Ocean Conservancy.
"The only person I've seen that wants this fish is the company itself," he said, adding that his group was certainly "on board" with Young's amendment. "We've had troubles with FDA's approval of this fish from the beginning."
While there may not be a broad outcry for the salmon, that may not be solid enough grounds for banning the fish.
This is a question of science, said David Edwards, director for animal biotech at the Biotechnology Industry Organization.
"It's unfortunate that the politics that has gotten into this," Edwards said. "It's really a problem that should be debated by scientific experts. And those experts are at FDA."
Already, FDA's experts have found the fish safe to eat, a finding echoed by many independent scientists. However, the agency has not yet issued an environmental assessment of what risks, if any, the salmon could pose to the environment.
When it rules, the agency could either call for a full EIS or approve the fish outright; either decision would then entail a month of public comment.
Debate over environmental impact
Many scientists have said that if the fast-growing fish allows salmon to be profitably grown away from the ocean, where fish farms cause heavy environmental damage through their waste and escaped charges, the AquaBounty salmon could be a theoretical win for the environment. But knowing if that theory translates into practice may require additional research confirming that the modified salmon would not thrive in wild conditions if it escaped.
AquaBounty's salmon grow twice as fast as conventional salmon, their DNA spliced with an always-on growth hormone gene from the chinook salmon. While fast-growing, they do not ultimately grow larger than their Atlantic salmon cousins. AquaBounty will also induce sterility into its all-female populations of the fish, though the firm's own assessments agree that these sterility controls could leave up to 5 percent of the fish sterile.
Some scientists have been critical of a provisional environmental assessment, prepared by AquaBounty and overseen by FDA, that the agency published on its website last fall. That report cited multiple proposed confinement methods -- including physical isolation and a high sterility rate -- to avoid a consideration of broader environmental impacts should a few fertile fish escape (Greenwire, Oct. 7, 2010).
Another sore point in the public discussion of AquaBounty's salmon has been the possibility that the fish, like all modified crops grown in the country, could be sold on store shelves without any labeling. Since the salmon is relatively indistinguishable from conventional and farmed salmon -- at least from a nutritional standpoint -- FDA may not have the regulatory authority to label it, the agency has said.
The amendment's ultimate fate is uncertain. The Senate is unlikely to approve the House spending bill unmodified, and it is unclear whether the amendment has the broad support to survive to final passage.