Genetically Engineered Salmon Labeling Act (S 1528, 115th Congress)
What it does
Requires additional labeling of genetically engineered salmon in the marketplace and calls for independent review of FDA environmental assessments leading to the approval of fish genetically engineered for human consumption.
The Genetically Engineered Salmon Labeling Act (S 1528) aims to enable customers to make informed decisions in purchasing genetically engineered (GE) salmon. It also aims to install external oversight on the Food and Drug Administration’s (FDA) review process for new animal drug applications (NADAs) regarding GE salmon and other GE finfish (true fish).
The bill designates that “salmon is genetically engineered if it has been modified by recombinant DNA (rDNA) techniques, including the entire lineage of salmon that contain the rDNA modification.” The market name of any salmon product that fits this criterion must be preceded by “genetically engineered” or the abbreviation “GE” in order to appropriately inform consumers of its content.
Additionally, S 1528 tasks the Department of Health and Human Services (HHS) with commissioning an independent scientific organization (e.g., the National Academy of Sciences) to review the following:
- Environmental assessments produced by the FDA (21 CFR 25.40) that cover GE finfish intended for human consumption. Such EAs are conducted during the FDA’s review of NADAs under Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360b).
- The FDA’s environmental assessment conducted for the AquAdvantage salmon-related NADA, with special consideration of the impact of GE salmon on wild salmon and ecosystems.
Approval of such NADAs will not come into effect until HHS carries out a second environmental assessment, taking into account the independent review.
AquaBounty, the company that owns AquAdvantage Salmon, created their original GE salmon in 1989. After further development, AquaBounty submitted its first regulatory study for a NADA in 2003. On November 12, the FDA issued an Environmental Assessment for AquAdvantage Salmon and found that the fish, under the conditions approved, would have “no effect” on the quality of the US human environment, including wild Atlantic salmon and their natural environment. Based on this, the FDA also issued a Finding of No Significant Impact (FONSI). On November 19, 2015, the FDA approved AquAdvantage Salmon to be the first GE animal cleared for consumption. However, Congress has required that the FDA ban the import of GE salmon until it finalizes labeling guidelines for GE salmon. Canada, on the other hand, has approved AquAdvantage Salmon for sale and leaves labeling up to the discretion of distributors.
Genetic engineering and recombinant DNA (rDNA) techniques are forms of biotechnology that enable the transfer of select individual genes from one organism to another. This process has been widely employed in modern agriculture to give rise to genetically engineered (sometimes referred to as “genetically modified”) foods, such as insect-resistant crops in which an insecticidal gene found in bacteria is incorporated into the plant genome.
AquaBounty Technologies has employed this biotechnology to significantly increase the growth rate of Atlantic salmon, and thereby reduce the time their GE salmon, named AquAdvantage Salmon, require to reach market size compared to non-GE counterparts. This result is accomplished by adding a growth hormone gene found in Chinook salmon and a gene promoter found in Ocean pout to the Atlantic salmon genome to accelerate growth.
Eric Hallerman, PhD, is a Professor of the Department of Fish and Wildlife Conservation at Virginia Tech University. His research interests lie in genetics of fish and wildlife species, genetic improvement of aquaculture stocks, aquaculture biotechnology, and related public policy.
“The Bill of a Genetically Engineered Salmon Labeling Act (S 1528, 115th Congress) should not be adopted, for several compelling reasons:
“First, this bill, sponsored by the Alaska delegation, is a transparent act of pandering to a vocal constituency in Alaska, the salmon fishers. Effectively, the bill aims to bar the marketing of a product that is perceived as competitive. Yet, anyone who shops for fish will know that salmon products are differentiated by species, as wild or cultured, and by region. For example, wild Alaskan sockeye salmon commands a higher price than cultured Chilean Atlantic salmon. The argument that GE salmon might escape and compete with Alaskan salmon is without merit, as all GE salmon will be produced under strict confinement, and far from Alaska. The real issue facing the Alaskan salmon fishers is the low dockside price for salmon, a consequence of the abundance of salmon in the fishery. Interference with the marketing of a similar product will have little or no effect on that problem. The Alaskan Congressional delegation seeks to be seen to be doing something for a small segment of the electorate.
“Second, the GE salmon is safe as food. Results of a wide range of analyses were publically reported in 2010 (https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm472487.htm), and the upshot is that products of GE salmon are indistinguishable from those of conventionally bred salmon.
“Third, the US FDA requires that the GE salmon are produced under stated “conditions of use”, that is, production of all-female, triploid fish under conditions of physical and geographic confinement. The fish cannot escape, and if they could, would not be able to persist or establish an invasive population. Hence, they are environmentally safe.
“Fourth, the US FDA is an agency of qualified professionals. It is capable of executing its science-based work and should do so without political interference from non-scientists in the Congress. That this bill singles out a particular product speaks directly to the point that it is political in nature.”
- Van Eenennaam, Alison L., Muir, William M., Hallerman, Eric M. 2013. “Is Unaccountable Regulatory Delay and Political Interference Undermining the FDA and Hurting American Competitiveness? A Response to Tim Schwab’s ‘Is FDA Ready to Regulate the World’s First Biotech Food Animal?” FDLI’s Food and Policy Forum, Volume 3, Issue 13.
Alison Van Eenennaam, Ph.D. is a Cooperative Extension Specialist in Animal Biotechnology and Genomics at the University of California, Davis. Her research interests lie in animal genetics, genetic improvement of food animals, agricultural biotechnology, and related public policy.
“It should be understood that wild-caught Pacific salmon from Alaska are marketed as such in order to obtain a premium price relative to cultured Atlantic salmon. It should be further noted that no Atlantic salmon (Salmo salar) has ever successfully mated with any of the Pacific salmon species (Oncorhynchus spp.) as they are different genera, and so fears that sterile, female Atlantic salmon housed in a contained facility in the highlands of Panama will escape, migrate to the ocean, and then traverse thousands of miles across tropical seas and interbreed with wild Alaskan Pacific salmon are scientifically unfounded… Requiring that the Department of Health and Human Services (HHS) authorize yet another study to consider the impact of genetically engineered salmon on wild salmon ecosystems (as outlined by S 1528) and review the FDA’s environmental assessment and subsequent approval for human consumption of AquAdvantage salmon is further evidence of political interference and stalling of the science-based work of the FDA. It is imperative that the United States stay the course it has set in not letting politics interfere with its science-based regulatory system. If the United States fails to provide a regulatory path to market for beneficial biotechnologies, research and development of these innovations will move to countries with more predictable policy environments.”
- Dennis, B. (2012) Genetically Altered Salmon are Safe, FDA Says, Washington Post, December 21, 2012, available at http://articles.washingtonpost.com/2012-12-21/national/36017637_1_ronald-stotish-aquabounty-technologies-atlantic-salmon.
- Du SJ, Gong ZY, Fletcher GL, Shears MA, King MJ, Idler DR, Hew CL. (1992) Growth enhancement in transgenic Atlantic salmon by the use of an "all fish" chimeric growth hormone gene construct. Biotechnology (N Y). 10(2):176-81.
- Van Eenennaam, Alison L., Muir, William M., Hallerman, Eric M. (2013). “Is Unaccountable Regulatory Delay and Political Interference Undermining the FDA and Hurting American Competitiveness?” FDLI’s Food and Policy Forum, Volume 3, Issue 13.
Endorsements & Opposition
There have not been any publicly reported endorsements of or opposition to this bill. However there is significant controversy surrounding both the issue of appropriate labeling for GE fish and the issue of whether the FDA had the appropriate level of expertise to conduct environmental assessments for AquAdvantage Salmon.
- Food & Water Watch’s Executive Director Wenonah Hauter released a statement on November 19, 2015 in support of labeling GE fish in the context of broader condemnation of the FDA approval, stating the following: “To add insult to injury, this product will be hitting store shelves without labeling, making it impossible for concerned consumers to distinguish GMO [genetically modified organism] from non-GMO salmon. Not only does this ignore consumers’ fundamental right to know how our food is produced, it is simply bad for business, since many consumers will avoid purchasing any salmon for fear it is genetically engineered.”
Food & Water Watch is a Washington, D.C. based NGO, which focuses on corporate and government accountability relating to food, water, and corporate overreach.
- A coalition of groups represented by legal teams from the Center for Food Safety and Earthjustice filed a lawsuit on March 31, 2016 against the FDA for their approval of GE salmon. The action calls into question the appropriate regulatory process for GE animals.
- The US Fish and Wildlife Service issued a letter to the FDA regarding the FDA’s environmental assessment. It stated: “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 this approval.”