The FDA is currently reviewing safety and labeling considerations surrounding what could be the first genetically-modified animal-based food. Aqua Bounty Technologies, Inc. (“ABT”) of Waltham, Mass. requested FDA to introduce “AquAdvantage Salmon” in U.S. food markets.
AquAdvantage Salmon are produced by introduction of an anti-freeze gene of an ocean pout fish and the growth hormone gene of Chinook salmon into North Atlantic salmon eggs. As a result, AquAdvantage Salmon grow produce growth hormone during the winter months, reaching maturity twice as quickly as ordinary North Atlantic salmon. These genetically-modified eggs, which were developed at Prince Edward Island in Canada, will be grown in an inland hatchery in Panama and processed at a nearby plant before shipment to the US.
The salmon is produced by taking a portion of the gene that protects the ocean pout fish against freezing, transplanting it into the growth gene of a Chinook salmon and transferring the blended genetic material into the fertilized eggs of a North Atlantic salmon.
The resulting fish grows during the winter months as well as the summer, unlike an ordinary salmon.
The FDA initiated three days of public hearings on the genetically-engineered (GE) salmon. On September 19-20, the FDA Veterinary Medicine Advisory Committee (VMAC) reviewed the scientific issues raised regarding the safety of AquAdvantage Salmon. On September 21, the FDA held a public meeting regarding the “legal principles for food labeling” applicable to AquAdvantage Salmon.
Sunday & Monday: Safety
In preparation for the public meeting, FDA staff concluded that genetically altered salmon that grow at twice the speed as normal salmon were as safe to eat as traditional Atlantic salmon and posed little environmental risk. According to the FDA staff analysis, “ABT salmon meets the standard of identity for Atlantic salmon as established by FDA’s Reference Fish Encyclopedia. All other assessments of composition have determined that there are no material differences in food from ABT salmon and other Atlantic salmon…” In reference to the environment, “no effects on stocks of wild Atlantic salmon are expected.” (ABT’s environmental assessment can be found here.)
Although many forecasted that the eleven-member, FDA advisory panel would vote to approve the “frankenfish,” as some critics called it, no vote was cast. Instead, the panel recommended further research. According to the Los Angeles Times:
The panel’s chairman, David Senior of Louisiana State University, said he thought members generally believed the fish was safe to eat, but were concerned that some studies had a small sample size.
One panelist, Greg Jaffe of the nonprofit Center for Science in the Public Interest, predicted after the meeting that the FDA would eventually approve the salmon, “but I don’t think the agency’s going to go quickly on this.”
Several panelists raised concerns about the fast-growing fish, saying there were not enough data to answer key questions about allergens and other potential risks.
“There are questions that have not been answered by the data that has been presented,” said panelist James McKean, a veterinarian and professor at Iowa State University. But other panelists argued there was no difference between the altered salmon and its natural counterpart.
“I would not feel alarmed about eating this kind of fish,” said Gary Thorgaard, a professor and fish researcher at Washington State University.
An interesting side-note to this discussion is the regulatory pathway for genetically engineered animals for human consumption. The rDNA introduced into the fish egg is considered a new animal drug for the purposes of the Federal Food, Drug, and Cosmetic Act (“FFDCA”) because it changes the structure or function of the GE animal. As such, the Veterinary Medicine Advisory Committee reviews the New Animal Drug Application for safety and efficacy, requiring the VMAC to determine:
- whether the article is safe to the animal to which it is administered, which for GE animals bearing heritable rDNA constructs, means the GE animals themselves;
- whether food derived from GE animals is safe, i.e., there is a reasonable certainty of no harm from the consumption of food derived from the GE animals; and
- whether there is likely to be a significant effect on the human environment.
More information about Atlantic salmon and FDA oversight of genetically engineered animals can be found here.
During Tuesday’s Part 15 hearing, the FDA sought public comment on “the labeling (including naming) of foods made from the AquAdvantage Salmon, a genetically engineered (GE) Atlantic salmon produced by AquaBounty Technologies, Inc.” Specifically, the FDA sought public views on:
- Which facts about the AquAdvantage Salmon seem most pertinent for FDA’s consideration of whether there are any “material” differences between foods from this salmon and foods from other Atlantic salmon. (Keep in mind that the use of genetic engineering does not, in and of itself, constitute a “material” difference under the law.)
- If FDA determined there are “material” differences, how would that difference be described on a food label in a way that is truthful and nonmisleading. (Keep in mind that it is the difference in composition, or in functional, organoleptic or other material properties that must be described, not the underlying production process.)
GE foods are subject to the same regulations as other foods, and must “bear an appropriate name and a label that is truthful and not misleading.” Many consumer advocates and environmental groups insisted that GE salmon, if approved, should be labeled as such. They argued that consumers have a right to know what they are eating. However, in Alliance for Bio-Integrity v. Shalala, the court granted deference to the FDA’s determination that genetic engineering does not materially alter foods, and therefore, that GE plants did not need to be labeled as such. According to the D.C. District Court, “the FDA lacks a basis upon which it can legally mandate labeling, regardless of the level of consumer demand.”
Some advocates also sought labeling as a method of monitoring safety. As the Los Angeles Times reports:
Consumer’s Union, the nonprofit publisher of Consumer Reports, opposed the approval of the salmon, saying it has not been shown to be safe, and argued it should be labeled in the event that it eventually reaches the market. “FDA should require labeling to insure that any unexpected or unintended effects of engineering this salmon … come to FDA attention,” said CU senior scientist Michael Hansen. “Drugs approved by FDA as safe have turned out to have unexpected health effects after they were widely used by consumers.”
The implication: Without labels, how would consumers, if they experience side effects, know that they had eaten GE salmon?
The great salmon debate is not one that will affect consumers in the near future. It is currently unclear how the FDA will decide on the safety issue and public comment on the labeling issue will remain open until November 22. Even if passed, ABT does not expect to have AquAdvantage products on market for another two years.