Genetically Engineered Salmon Risk Reduction Act

To reduce the risks associated with genetically altered salmon in the United States, and for other purposes. 1. Short title This Act may be cited as the Genetically Engineered Salmon Risk Reduction Act 2. Purposes It is the purpose of this Act to— (1) minimize the risk that genetically engineered salmon will be introduced into the marine environment off the coasts of Alaska, Washington, Oregon, and California; and (2) ensure that consumers in the United States can make informed decisions when purchasing salmon. 3. Amendments to the Federal Food, Drug, and Cosmetic Act (a) Labeling requirement Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 (z) If it contains genetically engineered salmon unless the food bears a label stating that fact. . (b) Requirement for environmental impact statement Section 512 ( 21 U.S.C. 360b (q) (1) Prior to the approval of any application filed under this section for genetically engineered salmon intended for human consumption, the Secretary, in consultation with the Under Secretary for Oceans and Atmosphere of the Department of Commerce, shall prepare an environmental impact statement (focused on the coast of the United States from California to Alaska) in accordance with section 102(2)(C) of the National Environmental Policy Act of 1969 that includes— (A) an environmental risk analysis that assesses the potential direct and indirect impacts from escapement of covered fish on wild and cultured fish stocks and environments that may be exposed to such covered fish; (B) a failure mode and effects analysis that quantitatively assesses the best- and worst-case probabilities of failure of each applicable confinement technique; (C) an assessment of the costs of control or eradication of escaped covered fish; and (D) an assessment of the potential economic damage in terms of loss of production and sales to relevant wild and cultured fish stocks and environments from the escapement of covered fish. (2) In this subsection, the term “covered fish” means a salmon or other anadromous or marine fish, live or dead, including the gametes, fertilized eggs, offspring, and descendants thereof, that is modified or produced using DNA from an organism’s own genome or that of another species, which overcome natural physiological reproductive barriers and which are not techniques used in traditional breeding and selection. .

Summary: Genetically Engineered Salmon Risk Reduction Act This bill amends the Federal Food, Drug, and Cosmetic Act to require food that contains genetically engineered (commonly called a "genetically modified organism" or "GMO") salmon to bear a label stating that fact. The bill requires the Food and Drug Administration (FDA) to prepare an environmental impact statement (EIS) under the National Environmental Policy Act of 1969 before approving a new animal drug application for GMO salmon intended for human consumption. (Currently, the FDA regulates GMO animals under the new animal drug provisions of that Act. If the FDA finalizes its environmental assessment and the Finding of No Significant Impact, it would not be required to prepare an EIS for that salmon.) The EIS prepared pursuant to this bill must focus on the coast along California to Alaska and GMO fish, including salmon, other anadromous fish (fish that migrate from the salt water of the sea to spawn in the fresh water of rivers), or marine fish. The EIS must include: an environmental risk analysis that assesses the potential impacts from escapement of the GMO fish on wild and cultured fish stocks and environments, a failure mode and effects analysis that assesses the best- and worst-case probabilities of failure of each confinement technique, an assessment of the costs of control or eradication of escaped GMO fish, and an assessment of the potential economic damage to relevant wild and cultured fish stocks and environments from the escapement of GMO fish.