	Introduction

On November 19, 2015, the Food and Drug Administration (FDA) approved AquaBounty Technologies' application to produce AquAdvantage Salmon, a genetically engineered (GE) Atlantic salmon, for human consumption. This is the first GE animal that has been approved for human consumption in the United States. FDA also has proposed voluntary guidelines for using labels that indicate whether food products are derived from GE salmon. These techniques are now being used to develop genetically engineered organisms for the aquaculture industry. Some have claimed that FDA's approval of GE salmon has been long overdue and the delays have been caused by political interference. They conclude that delays have hindered investment and development of the U.S. biotechnology sector. Another concern is that GE fish may interbreed with wild fish and allow the modified genetic material to become assimilated into the wild fish population. In addition, some in the fishing industry are concerned that greater efficiency in the aquaculture industry could harm salmon fisheries. In response to these concerns, legislation has been introduced during the last several Congresses to restrict the use and require the labeling of GE organisms. H.R. Two FY2016 appropriations bills for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies ( S. 1800 and S. 2129 ) include provisions that would provide funds to implement labeling requirements for GE salmon. 394 would prohibit most uses of GE fish, with some exceptions or if certain conditions are met. 4321) or an environmental impact statement (EIS). Most of FDA's regulatory authority to regulate food safety is provided by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §321). Salmon will be processed in Panama before being shipped to the United States for retail sale. Both facilities currently used by AquaBounty confine production to land-based freshwater areas. According to the application, production will continue in this manner. In 2009, AquaBounty provided FDA with the last required study of AquAdvantage Atlantic salmon for its new animal drug application (NADA). On November 19, 2015, FDA approved the Aquabounty application to produce GE Atlantic salmon and to sell this product in the United States. In the preliminary finding of no significant impact released on December 20, 2012, FDA reiterated that food from AquAdvantage Salmon is as safe as food from non-GE salmon and determined that there are no significant food safety hazards or risks associated with AquAdvantage Salmon. However, the potential consequences of the interbreeding of farm (including GE salmon) and wild Atlantic salmon remain a long-term concern of those attempting to conserve wild Atlantic salmon populations. Fishermen have concerns related to further increases in salmon aquaculture production and environmental harm to wild stocks. At least initially, annual production at the AquaBounty Panama facility is limited to a capacity of approximately 100 metric tons compared to the total U.S. fresh and frozen salmon supply of approximately 700,000 metric tons in 2014. 913 and S. 511 ) would require labeling of GE food products, including GE salmon. H.R. H.R. In addition to labeling requirements, S. 738 would require an EIS for any application related to the use of GE salmon intended for human consumption. In the 113 th Congress, several bills related to the production and labeling of GE salmon were introduced. S. 246 and H.R. H.R. H.R. Future Considerations

Some have asserted that the FDA's approach to GE salmon evaluation has failed to consider the full scope of potential impacts or to fully assess the risk of unintended consequences. FDA evaluated GE salmon as an NAD that is safe for human consumption. Questions remain as to whether the current process can afford adequate safeguards for the public and the environment while allowing for the timely approval and use of new genetic technologies.
On November 19, 2015, the Food and Drug Administration (FDA) approved AquaBounty Technologies' application to produce AquAdvantage Salmon, a genetically engineered (GE) Atlantic salmon, for human consumption. This is the first GE animal that has been approved for human consumption in the United States. FDA also has proposed voluntary guidelines for using labels that indicate whether food products are derived from GE salmon.
Genetic engineering techniques are used by scientists to insert genetic material from one organism into the genome of another organism. Genetically engineered salmon have been modified to grow more quickly and to use feed more efficiently. However, some are concerned that, in this rapidly evolving field, current technological and regulatory safeguards are inadequate to protect the environment and ensure that these products are safe to eat.
Nearly twenty years ago, AquaBounty Technologies Inc. began the application process to obtain FDA approval for a genetically engineered Atlantic salmon. In 2009, AquaBounty submitted the last required study for its new animal drug (NAD) application. The FDA is regulating GE Atlantic salmon as an NAD under the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §321). An NAD is approved by the agency only after the drug is shown to be safe and effective. FDA has concluded that AquAdvantage Salmon is as safe as food from non-GE salmon and determined that there are no significant food safety hazards or risks associated with the product.
Environmental concerns related to the development of GE salmon include the potential for competition and interbreeding with wild fish. According to some, escaped GE salmon could spawn with wild Atlantic salmon and introduce the modified genetic material to the wild population. To address these concerns, AquaBounty will produce salmon eggs (all sterile females) in Canada, ship these eggs to Panama, grow and process fish in Panama, and ship table-ready, processed fish to the United States for retail sale. Aquabounty will limit production to land-based facilities to isolate GE salmon from the environment and minimize the likelihood of harm to wild fish populations. Production from these facilities is limited to approximately 100 metric tons, which is a small fraction of the current U.S. fresh and frozen salmon supply of 700,000 metric tons.
Some have asserted that FDA approval of AquAdvantage Salmon was overdue and that delays have hindered investment and development of the U.S. biotechnology sector. Others have questioned the adequacy of FDA's review of GE salmon and whether the existing approval process is equipped to fully evaluate the risks of this technology, especially potential environmental harm. Additional concerns have been voiced concerning food safety, labeling of GE salmon, and economic effects on existing wild salmon fisheries.
In response to concerns related to the production and use of GE salmon as food, legislation has been introduced during the last several Congresses to restrict the production and require the labeling of GE organisms. Legislation introduced in the 114th Congress related to labeling GE salmon specifically or to GE organisms generally includes H.R. 393, S. 738, H.R. 913, S. 511, and H.R. 1599. Two FY2016 appropriations bills for Agriculture, Rural Development, Food and Drug Administration and Related Agencies (S. 1800 and S. 2129) include provisions that would provide funds to implement labeling requirements for GE salmon. H.R. 394 would prohibit most uses of GE fish, with some exceptions or if certain conditions are met. In addition to labeling requirements, S. 738 would require an environmental impact statement for any application to produce GE salmon intended for human consumption. H.R. 1599 has been passed by the House, and H.R. 1800 has been reported by the Senate Committee on Appropriations. Since they were introduced, no further action has been taken on the other bills related to genetic engineering.