Questions about AquAdvantage® Salmon
Q. Why do we need AquAdvantage® Salmon?
Approximately 85 percent of world fish stocks are estimated to be overexploited, depleted or endangered at a time when the demand for fish protein is exploding—up from 14.4 kg in the 1990s to 17.1 kg in 2011 – an 18.8% increase in per capita consumption. With the world population expected to attain nearly 10 billion by 2050, demand for critical sources of protein continues to substantially outstrip the available supply.
Aquaculture – responsible for more than half the fish consumed in the U.S. today – provides a means of at least partially meeting this demand, but we cannot expect to feed a burgeoning global population without employing every tool at our disposal, including enhancing aquaculture productivity through genetic engineering. Fast-growing fish produced from AquAdvantage® Salmon eggs are one of at least 18 different accelerated growth varieties of fish under development in countries around the world that can help us to feed an overpopulated planet. It is the first to undergo review by a regulatory body so that it can begin to provide people with a safe, valuable and healthy source of much-needed protein, while simultaneously reducing the pressure on wild fisheries.
Q. How are AquAdvantage® Salmon different from other Atlantic salmon?
AquAdvantage® Salmon include a gene from the Chinook salmon, which provides the fish with the potential to grow to market size in half the time of conventional salmon. In all other respects, AquAdvantage® Salmon are identical to other Atlantic salmon.
Q. Are the salmon grown from AquAdvantage® eggs also genetically modified?
Although salmon grown from AquAdvantage® eggs are the same biologically and nutritionally as any other Atlantic salmon, their accelerated growth comes from the addition of a growth hormone gene from the Chinook salmon. The Chinook growth hormone is the same as the Atlantic salmon growth hormone; it is simply regulated differently. Their ability to grow faster does not change the biological make-up of the fish. It is important to note that AquAdvantage® Salmon expresses a salmon protein in a salmon.
Q. How well has AquAdvantage® Salmon been researched?
The development of AquAdvantage® Salmon began in 1989 and has a 25-year history of scientific research, making it the most studied line of Atlantic salmon in aquaculture.
Q. Does AquAdvantage® Salmon reach a larger size than conventional Atlantic salmon, and if so, could they gain a mating advantage or out-compete native salmon for food or space?
No. While AquAdvantage® Salmon grow faster in early life stages than other salmon, they do not grow larger than conventional Atlantic salmon. Being all-female and sterile, AquAdvantage® Salmon cannot mate and produce viable eggs, therefore they do not pose a competitive threat to wild salmon populations. Farming them in land-based facilities from which escape is practically impossible, eliminates the risk of interactions with wild salmon populations.
Q. Does the Trojan Gene Theory apply to the AquAdvantage® Salmon when discussing the potential environmental risk that the AquAdvantage® transgene could find its way into wild salmon populations?
Muir and Howard, the Purdue scientists who proposed the “Trojan Gene Hypothesis,” did not study AquAdvantage® Salmon. They designed a mathematical model based on the behavior of Japanese medaka, a small freshwater fish that matures in 56 days and breeds daily until it dies. Salmon take three, five or even ten years to mature and most breed only once in their lifetime. AquaBounty has further stipulated that it will market only sterile, all female AquAdvantage® Salmon. Since these fish are unable to reproduce, there can be no gene flow to wild salmon. As a further precaution, AquAdvantage® Salmon will be reared in physically contained facilities. AquAdvantage® Salmon will thus be raised with redundant biological and physical containment, mitigating any potential risk of a negative impact on genetic diversity of wild stocks. Most importantly, Dr. Muir has made a presentation at the VMAC, and later in publication stating clearly that AquAdvantage salmon are not an example of the “Trojan Gene Hypothesis”, and in fact represent a lower environmental risk than the current practice.
Q. Can we be sure that AquAdvantage® Salmon will really be sterile?
Yes. There are specific tests to establish the effectiveness of our process to produce sterile fish. These tests will be performed on every commercial batch of fish to assure our product meets our specifications.
Q. Do AquAdvantage® Salmon produce antifreeze proteins and excessive amounts of growth hormone?
No. AquAdvantage® Salmon produce no antifreeze proteins. Only the promoter, the molecular “switch” from the antifreeze protein gene is used. AquAdvantage® Salmon produce the exact same growth hormone as wild-type Atlantic salmon, and there is no increase in the level of this protein as compared to conventional Atlantic salmon.
Q. If approved by the FDA, where will production of AquAdvantage® Salmon be authorized?
The New Animal Drug Application (NADA) currently under review by the FDA encompasses two potential production sites. AquAdvantage® Salmon eggs will be produced at AquaBounty’s breeding center in Canada (which was approved in 2013 by the Canadian government for the production of AquAdvantage® Salmon eggs.) Growout and production for sale into the USA would occur at AquaBounty’s production site in Panama. No other production sites are contemplated under the NADA currently being reviewed by the FDA.
Questions about Federal Regulation of Advanced-Hybrid Fish
Q. How thorough is the review and approval process?
The U.S. Food and Drug Administration (FDA) have gone to great lengths to ensure that the review process for this first application for a transgenic food animal is completely beyond reproach. In fact, it is putting all genetically modified food animals through the more rigorous review process it uses for drugs, because the health and safety requirements for drugs are the toughest and most demanding that exist and they are considered the “gold standard” for safety throughout the world. AquAdvantage® Salmon, a fish biologically and chemically indistinguishable from conventional Atlantic salmon, which has now been exhaustively studied for more than 25 years, is going through a far tougher and more critical review than any other food product on the market. Should the FDA deem this salmon safe to eat, consumers can have total confidence in this thoroughly researched conclusion.
Q. Are there federal laws that govern the regulation of genetically engineered fish and marine organisms grown for human consumption?
Yes. AquAdvantage® Salmon are regulated by the Center for Veterinary Medicine (CVM) under the Food, Drug and Cosmetics Act. As far back as 1986, the U.S. Food and Drug Administration (FDA) asserted jurisdiction over genetically engineered animals and fish on the grounds that the transgene and any expressed proteins, affect the “structure and function” of the receiving animal analogous to the modalities of veterinary drug formulations. FDA jurisdiction has been upheld by the federal courts.
Q. Does the FDA evaluate the environmental impact of advanced-hybrid fish or does it limit any assessment to the molecular attributes, pharmaceutical effects or the impacts of any chemicals used in the engineering process? And does their environmental risk assessment extend to potential ecological impacts?
Environmental risk assessment at FDA is governed by the National Environmental Policy Act (NEPA) and the regulations implementing NEPA adopted by the Council on Environmental Quality (40 CFR Parts 1500 to 1508) and by FDA (21 CFR Part 25). The NEPA and CEQ obligations imposed on the agency are identical to those required of all agencies throughout the federal government, including the identical scope of environmental risk assessment. The agency’s position on the scope of environmental risk assessment required to process new drug applications is detailed in its 1998 guidance: “FDA considers harm to the environment to include not only toxicity to environmental organisms but also environmental effects other than toxicity, such as lasting effects on ecological community dynamics.”
Q. Does the FDA possess the expertise in fisheries biology, ecology and environmental science to assess the environmental risks of advanced-hybrid fish?
The FDA’s staff includes specialists trained in biology, environmental science and risk assessment who have conducted hundreds of environmental impact assessments. Each assessment is based on the explicit assumption that the ultimate repository of agency-approved pharmaceuticals or food additives will be aquatic ecosystems following their production, use or disposal. NEPA and CEQ require federal agencies to cooperate with other affected agencies in the assessment of the environmental impacts of agency actions. In addition, the CVM consults with other federal agencies, such as National Marine Fisheries Service and the National Oceanic and Atmospheric Administration as needed.
Q. Is science-based risk assessment adequate for the evaluation of the environmental impacts of biotechnology?
Science-based risk assessment identifies potential hazards, quantifies the probabilities those hazards will occur and accounts for uncertainty with significant safety thresholds – typically set at 1000 times the likely level that a risk will occur. This approach is wholly compatible with precaution. The science-based process, according to a former undersecretary of Commerce in the Clinton administration, David Aaron, has “shown us that biotech foods developed and used in the U.S. present no safety risk beyond those of their ‘natural’ counterparts. Not a single ailment has been attributed to biotech foods”. Similarly, environmental scares ranging from Monarch butterfly impacts to increased pesticide use to advanced-hybrid superweeds have all been disproved by adequate research or avoided by appropriate agricultural practice or regulatory standards. The Precautionary Principle as adopted in the 1992 Rio Declaration calls only for “cost effective measures to prevent environmental degradation” when “threats of serious or irreversible damage” lack “full scientific certainty.” U.S. risk management practice meets this test.
Q. What about the potential environmental impact?
Environmental activists have questioned whether fish grown in closed aquaculture systems could escape into the wild and establish breeding populations that might threaten native fish stocks. Thorough investigation has shown there is no reason to believe AquAdvantage® salmon could either escape from their land-based contained systems or reproduce in the wild and that they pose no threat whatsoever to wild salmon populations. AquAdvantage® salmon will be grown as sterile, all-female populations in land-based facilities with redundant means of containment. In fact, they pose significantly fewer risks than the current industry practice of farming fertile, mixed-sex populations of cultured salmon in ocean pens from which millions of fish escape on an annual basis. One of the major benefits of these physically contained, land-based production facilities is their efficiency and increased productivity. AquAdvantage® land-based facilities reduce impact on coastal areas; eliminate the threat of disease transfer from farms to wild fish; and grow more fish with less feed. They also permit greater control of inputs and waste products, allowing operators to control both more efficiently. Further, production systems can be sited anywhere, not just in sensitive coastal areas, and can be located near major consumer markets, thus further reducing the environmental impact associated with air and ocean freight. With the world population growing, and demand for healthy protein sources increasing, technologies such as this will help the U.S. lead the way in safely and efficiently producing a globally important source of animal protein.
Q. What about the health concerns being voiced about eating AquAdvantage® Salmon?
Critics argue that the sample size used for AquaBounty’s studies on allergenicity was insufficient. However, the FDA was satisfied with the data and concluded there were no concerns regarding allergenicity. What’s more, its analysis concluded that AquAdvantage® Salmon are no different than any other Atlantic salmon in terms of allergenicity. Others worry that GE fish are more susceptible to diseases and therefore will receive more antibiotics that might be harmful to humans and could cause fatal allergic reactions. Again, this is false. Commercially popular strains of Atlantic salmon that are commonly used in salmon farming formed the genetic foundation for AquAdvantage® Salmon, so AquAdvantage® Salmon are not more vulnerable to disease than conventional lines of Atlantic salmon commonly used in salmon farms. AquAdvantage® Salmon will be less exposed to disease because they will be raised in a land-based system. Therefore, there would be a reduced need for antibiotics. There is absolutely no evidence that these fish might accumulate toxins in any way differently than conventionally farmed salmon. Due to inherently better biosecurity measures, salmon grown in land-based systems will have even less disease incidence and reduced need for treatment compared to conventional production.
Q. Shouldn’t AquAdvantage® Salmon be labeled as genetically modified?
The nutritional and biological composition of AquAdvantage® Salmon is identical to Atlantic salmon. On this basis, current law and policy would not require additional labeling based upon method of production. The product should be labeled “Atlantic salmon.” The FDA has the legal authority to require labeling when there is a difference in the nutritional value, composition, safety (allergenicity) or processability of a food compared with its traditional counterpart. The bottom line on labeling is that it must be truthful and in no way mislead the consumer. Labeling must provide to the consumer necessary and relevant information on nutrition and safety. We do, however, support voluntary branding by the farmers who grow our salmon, which will help identify the environmentally friendly benefits of this product. The question of labeling is essentially a marketing issue, and not a food safety concern.
Q. Why are some people proposing a ban on genetically engineered (GE) fish?
Despite the numerous benefits of transgenic salmon, Alaska’s Congressional delegation has introduced legislation that calls for a halt to FDA approval of this product, as well as a separate bill that would require GE fish to be labeled as such. This legislation is misguided on many levels. The senators are acting based on unfounded fears, not hard data, citing concerns that AquAdvantage® Salmon would threaten wild stocks and their habitat – neither of which has any basis in fact. Their claims of food safety and environmental risk are contradicted by the documents and data made public by the FDA after the VMAC meeting. The senators also cite concerns that AquAdvantage® Salmon would have an adverse economic impact on Alaska’s salmon fisheries, though it’s far more likely that the opposite would occur. AquAdvantage® Salmon, if approved, will compete in the market segment currently supplied by imported foreign Atlantic salmon. The existing market is shared between wild caught Alaskan and imported farm raised Atlantic salmon. The Alaskan wild caught industry can perhaps satisfy one-half of the existing U.S. demand for salmon, and commands a premium price due to its successful market presentation. Alaskan fisheries are well managed, but of finite capacity. The availability of AquAdvantage® Salmon can help meet demand for a safe and sustainable food by providing a U.S.-grown farmed Atlantic salmon, without stressing the valuable and finite Alaskan fisheries, preserving their markets.
More information is posted on the FDA website: