Genetically Engineered Salmon Labeling Act

To amend the market name of genetically altered salmon in the United States, and for other purposes. 1. Short title This Act may be cited as the Genetically Engineered Salmon Labeling Act 2. Purposes It is the purpose of this Act to— (1) ensure that consumers in the United States can make informed decisions when purchasing salmon; and (2) authorize an independent scientific and technical advisory organization to conduct a review of— (A) the possible effects of genetically engineered salmon on wild salmon stocks; and (B) the Food and Drug Administration’s approval of genetically engineered salmon for human consumption. 3. Market name for genetically engineered salmon (a) In General Notwithstanding any other provision of law, for purposes of applying the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 GE (b) Definition For purposes of this section, 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. 4. Third-party review of certain salmon approval (a) Independent scientific organization review and report The Secretary of Health and Human Services (referred to in this section as the Secretary (1) the environmental assessment carried out by the Food and Drug Administration and released on November 12, 2015, in support of approval of the new animal drug application under section 512 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360b (2) each environmental assessment carried out by the Food and Drug Administration in support of an approval of a new animal drug application under section 512 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360b (b) Second FDA environmental assessment After receipt of a report under paragraph (1) or (2) of subsection (a), the Secretary shall conduct a second environmental assessment with respect to approval of the application described in such paragraph (1) or (2), taking into account the findings in such report. (c) Effective date of approval Notwithstanding any other provision of law, the approval of a new animal drug application with respect to which review of an environmental assessment is required under subsection (a) shall not take effect until the Secretary completes a second environmental assessment under subsection (b).

Summary: Genetically Engineered Salmon Labeling Act This bill requires the market name of genetically engineered (commonly called "genetically modified" or "GMO") salmon to include "Genetically Engineered" or "GE" in front of the existing market name. The Department of Health and Human Services must ensure that an independent scientific and technical advisory organization reports on: (1) the Food and Drug Administration (FDA) environmental assessment of AquAdvantage Salmon, and (2) each FDA environmental assessment in support of approval of a new animal drug application for a genetically engineered finfish intended for human consumption. Upon receipt of a report from the independent organization, the FDA must conduct a second environmental assessment of the fish, taking into account the report's findings. The approval of a new animal drug application for a genetically engineered fish does not take effect until the second environmental assessment of the fish is completed.