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. By a broad definition, "genetic modification" refers to changes in an organism's genetic makeup that do not occur in nature. For millennia, farmers and scientists have modified the genetics of animals by selecting those individuals with desirable traits for further breeding. With the advent of modern biotechnology (e.g., genetic engineering or bioengineering), it is now possible to take a gene (or genes) for a specific trait from an organism and transfer it to another organism of a different species. For the purpose of FDA's guidance to industry, FDA defines genetically engineered (GE) animals as those animals modified by recombinant deoxyribonucleic acid (DNA), known as rDNA, techniques, including the entire lineage of animals that contain the modification. Recombinant DNA techniques expand the range of traits that may be transferred to another organism and increase the speed and efficiency by which desirable traits may be incorporated into organisms. Desirable traits may reduce production costs and sometimes make the organism or products made from it more desirable to consumers. Genetically engineered plant varieties, such as herbicide-resistant corn and soybeans, have already been widely adopted by U.S. farmers. These techniques are now being used to develop genetically engineered organisms for the aquaculture industry. Approximately 50 species of fish have been subject to genetic modification and more than 400 fish/trait combinations have been developed. Fish and other marine organisms are being modified to reduce production costs of human food, to produce pharmaceuticals, to test water contamination, and for other uses. Fish are particularly attractive candidates for genetic engineering because they produce eggs in large quantities and their eggs are more easily manipulated because they are fertilized and develop externally. Aquaculture also supplies a rapidly expanding market of different seafood products. Countries with active research programs for genetically engineered fish include China, Cuba, India, Korea, the Philippines, and Thailand. 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. They also question whether biotechnology industries in the United States will be able to compete with companies in other parts of the world. Moreover, they hypothesize that the availability of GE salmon at relatively low prices could benefit consumers who are seeking low-fat and affordable options. Development of GE fish has prompted some advocacy groups to raise a number of environmental concerns. For example, if fish are accidently released into the environment, they may spread and be difficult to contain. GE fish that escape to the wild could compete with wild fish and harm wild populations. 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. Sterilization and bioconfinement have been proposed to isolate GE fish from wild fish populations. Food safety concerns also have been expressed by consumer groups who question whether genetically modified organisms could pose unique hazards to public health. These groups also support mandatory labeling of GE products because they believe consumers have a right to make informed choices. In addition, some in the fishing industry are concerned that greater efficiency in the aquaculture industry could harm salmon fisheries. Salmon farm production in the 1990s depressed salmon prices and affected fishing businesses and coastal communities that depend on wild 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. In the 114 th Congress, two bills have been introduced ( H.R. 393 and S. 738 ), which would require labeling of GE salmon. In addition, two more general bills ( H.R. 913 and S. 511 ) would require labeling of GE food products, including GE salmon. H.R. 1599 would preempt any state authority over GE labeling in favor of a voluntary National Genetically Engineered Food Certification Program under the federal Agricultural Marketing Act of 1946. The certification program would establish national standards for labeling both GE and non-GE foods. 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. Applications for uses that would be prohibited under H.R. 394 would require an environmental assessment (EA) with a finding of no significant impact in accordance with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321) or an environmental impact statement (EIS). The EIS also would be required to include analysis of the risk associated with the escape of GE fish. In addition to labeling requirements, S. 738 would require an EIS before approval of any application to produce GE salmon intended for human consumption. Federal guidance for regulating biotechnology products is provided in the Coordinated Framework for Regulation of Biotechnology (51 Fed. Reg. 23302), published in 1986 by the White House Office of Science and Technology Policy (OSTP). A key regulatory principle of the U.S. biotechnology regulatory structure is that genetically engineered products should continue to be regulated according to their characteristics and unique features, not their production method—that is, whether or not they were created through biotechnology. The framework provides a regulatory approach intended to ensure the safety of biotechnology research and products, using existing statutory authority and previous agency experience with traditional breeding techniques. The three lead agencies are the U.S. Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA) at the Department of Health and Human Services, and the Environmental Protection Agency (EPA). In 2002, the National Research Council (NRC) published its report on animal biotechnology. Some newer applications of biotechnology did not exist when the current regulatory framework was enunciated. The NRC animal biotechnology report concluded that this General Framework "might not be adequate to address unique problems and characteristics associated with animal biotechnologies" and that federal agency responsibilities are not clear. FDA regulates food, animal feed additives, and human and animal drugs, including those from biotechnology, primarily to ensure that they pose no human health risks. Most of FDA's regulatory authority to regulate food safety is provided by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq . ) and the Public Health Service Act (42 U.S.C. §201 et seq . ). Under the FFDCA, all food and feed manufacturers must ensure that the domestic and imported products they market, except for most meats and poultry, are safe and properly labeled, including those developed through genetic engineering. FDA has stated that most—although probably not all—gene-based modifications of animals for production or therapeutic claims fall within the purview of the agency's Center for Veterinary Medicine (CVM), which regulates them under the FFDCA as new animal drugs (NADs) (21 U.S.C. §321). Under the FFDCA, drugs are defined in Section 201(g) as "articles intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function in the body of man or other animals." On January 15, 2009, CVM released its industry guidance for producers and developers of GE animals and their products. The guidance provides an approach to satisfy applicable statutes and regulations. The guidance states (on page 6): "The rDNA construct in a GE animal that is intended to affect the structure or function of the body of the GE animal, regardless of the intended use of products that may be produced by the GE animal, meets the FFDCA drug definition." An NAD is assumed to be "unsafe" unless FDA has approved a new animal drug application (NADA) for that particular use, or the NAD is for investigational use and subject to an exemption from the drug approval requirement (among a few other specified exemptions). FFDCA and federal regulations describe information that must be submitted to FDA as part of NADAs. The industry guidance lays out the pre-market approval process, including the information required of applicants which fulfills the regulatory requirements. Required information is broken out into six categories, which include product identification, molecular characterization of the construct, molecular characterization of the GE animal lineage, phenotypic characterization of GE animal, genotypic and phenotypic durability assessment, and the food/feed safety and environmental safety assessments. The food safety assessment includes examination of both the direct toxicity (including allergenicity) potential of food from a GE animal as well as any indirect toxicity. Food and feed will be considered safe if the composition of edible materials from the GE animal can be shown to be "substantially equivalent" to that from a non-GE animal. Therefore, if animals of the same or comparable type are commonly and safely consumed, there is a presumption that food from the GE animal is safe and the product will not have to be labeled. An FDA decision regarding an NADA is a federal action subject to the National Environmental Policy Act (NEPA; 42 U.S.C. 4321). NEPA requires federal agencies to consider the environmental consequences of an action before proceeding with it and to involve the public in its decision-making process.