Genetically modified salmon moved closer to the market last week with release of draft documents from the Food and Drug Administration that assessed the environmental risks posed by AquAdvantage salmon, which grow faster than regular Atlantic salmon.
The agency found, on a preliminary basis, that the GM fish, produced by AquaBounty Technologies of Massachusetts, posed no significant threat.
Both documents -- an environmental assessment and preliminary “finding of no significant impact,” known by the policy wonks as a FONSI -- will be published Dec. 26 in the Federal Register and be available for public comment for 60 days.
The assessment focused on the environmental questions. Food safety came earlier. Back in 2010, the FDA concluded that the salmon “is as safe as food from conventional salmon, and there is a reasonable certainty of no harm from consumption.” For example, the flesh of the fish contain no more growth hormone than regular Atlantic salmon, the FDA said -- a concern of opponents to the fish because of the manner in which they were genetically engineered.
The new documents aren’t exactly light Yuletide reading, filled as they are with regulatory-agency speak and charts of containment facilities and weather reports from sundry Canadian islands. They go over in some detail the way the fish were created, how and where they will be reared and whether the proposed strategy poses risks to wild salmon or otherwise on the environment.
Here are a few of the points, but anyone who’s really interested or concerned should probably wade through the entire document, fortified perhaps with some brandy-spiked eggnog.
How is the salmon genetically modified?
AquAdvantage salmon is Atlantic salmon engineered with a gene from chinook salmon. The gene carries instruction for making growth hormone; that gene is attached to -- and activated by -- a piece of DNA from an ocean pout. The hybrid DNA was microinjected into fertilized salmon eggs back in 1989, to create the first “founder” GM fish. Because of the growth hormone supplied by the added gene, the salmon reaches smolt stage in its lifestyle faster than other Atlantic salmon. (Smolt is the stage when the salmon becomes silvery and would be ready to migrate to the ocean.) Faster growth time to smolt cuts down on feed costs and time to market and thus would make land-based salmon farming more economical, says AquaBounty Technologies, makers of the GM salmon. The FDA notes that 99% of the Atlantic salmon we eat in this country comes from farmed salmon operations in Canada Chile, Norway and Scotland.
How would it be farmed?
Unlike conventionally farmed salmon, the proposal the company put before the FDA doesn’t involve farming the fish in net pens in the ocean. Instead, fertilized eggs would be created in inland tanks in Canada (on Prince Edward Island) and the eggs would be transported to an inland facility in Panama to reach maturity in tanks. The farmed fish would be 100% female and almost all triploid — meaning they carry three copies of every chromosome in each cell instead of the normal two. That makes them sterile. They would be processed in Panama, and salmon fillets and steaks would then be transported to the U.S.
What did the environmental assessment look at?
It reviewed the scientific evidence to draw conclusions on a number of essential questions: the likelihood that the salmon would escape from the facilities, and, if they did escape, how likely they’d be to survive, disperse, reproduce and establish themselves in the wild; and the likely environmental effects within the U.S. if all those things happened. Environmental effects in Canada and Panama are not within the FDA’s purview, but the FDA noted that potential physical effects on the U.S. would have to depend on security and containment of the facilities in Panama and Canada, so it looked at those. Those countries also have their own rules and regulations for assessing genetically modified animals.
The FDA wrote that the plans for these salmon confine them physically, geographically and biologically: The fish are sterile, grown in facilities on land with redundant containment measures, and the report goes into detail about all of these. For example, you can read about the confinements starting on Page 13 and later on in more detail, including a table (on Page 46) and figure (Page 47) that describes the various physical containment measures planned at Prince Edward Island; followed by a table and figure for the Panama facility on pages 52 and 53.
The agency concluded that the probability of escape, reproduction and establishment in the wild or harm to the Atlantic salmon or the human environment in the U.S. were very unlikely.
Some opponents of the AquAdvantage salmon expressed concerns, given the distressed state of wild Atlantic salmon fisheries, that the U.S. Fish and Wildlife Service and National Marine Fisheries Service were not involved in the environmental assessment. FDA spokeswoman Shelly Burgess said that both agencies (as well as the U.S. Department of Agriculture) provided comments on the draft. You can read their comments on pages 135 and 136 of the report. And starting on Page 100, you can read about all the various agencies who were consulted during the process.
The Fish and Wildlife Service noted that approval would be only for the planned two facilities on Prince Edward Island and in Panama. And it wrote: “Concern for effects on listed Atlantic salmon would arise if there were a detectable probability that the transgenic salmon could interbreed or compete with or consume the listed fish. Given the nature of the facilities described, any of these outcomes appears to be extremely unlikely, and your ‘no effect’ determination seems well supported for approval.”
But the Fish and Wildlife Service also noted that this was based on the farming scheme as currently laid out. If more facilities were planned, or facilities different in kind were planned, or facilities in the United States planned, AquaBounty would have to apply to the FDA each time and the FDA would review any major or moderate changes in plans. The FDA said in the draft environmental assessment that ocean-based pens were a nonstarter because farmed salmon escape from them.
Would the genetically modified fish carry labels?
The hard plastic coolers transporting fish eggs in transit from Prince Edward Island to Panama would be labeled. But there no decision has been made on labeling of the final product. “Should FDA approve the application related to AquAdvantage Salmon, the agency will make a determination on whether food derived from AquAdvantage Salmon requires additional labeling,” Burgess said.
What happens next?
The FDA could decide to move ahead and finalize that FONSI, paving the way toward ultimate approval of the salmon, or it could decide to do a more detailed environmental analysis. (Page 9 provides a figure describing the steps involved approval of a genetically engineered animal.)
In an email, FDA Burgess said: “FDA will review the comments it receives from the public regarding this draft [Environmental Assessment] and preliminary FONSI before making a decision on whether to prepare a final [Environmental Assessment] and FONSI, or to prepare an [Environmental Impact Statement]. In addition, FDA will complete the review of the AquAdvantage Salmon application and will reach a decision on approval. At this point it is not possible to predict a timeline for when these decisions will be made.”
Though “environmental assessment” and “environmental impact statement” may sound very much alike, they are not. An environmental assessment is a more concise document that is prepared, in part, to determine whether agencies need to take a more detailed look. Not that these are exactly slim documents: The one prepared for the GM salmon was 145 pages long.
As explained by the EPA, environmental impact statements “are generally prepared for projects that the proposing agency views as having significant prospective environmental impacts.” The FDA doesn’t see that being the case for the salmon.