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The company that has developed a genetically modified (GM) salmon has reportedly filed an application with Health Canada seeking its approval to market the fish for human consumption. AquaBounty received the approval of Environment Canada in November 2013 to produce GM salmon fish eggs at its Prince Edward Island hatchery—a decision that has been challenged by three environmental groups—and is still awaiting U.S. approval before its fish and eggs can be sold there. The company said that it “currently expects to market AquAdvantage Salmon in the United States, Canada, Argentina, Chile, and China following receipt of required regulatory approvals in the applicable jurisdiction.” See The Canadian Press, March 11, 2014.   Issue 517

The nation’s two largest grocery stores, Kroger and Safeway, have pledged not to sell genetically engineered (GE) salmon, joining a growing group of stores, including Target, Whole Foods, Trader Joe’s, Aldi, H-E-B, Meijer, Hy-Vee, Marsh, and Giant Eagle, that have already rejected the GE salmon currently under final review by the U.S. Food and Drug Administration (FDA). Nearly 2 million people, including scientists, fishermen, business owners, and consumers, have written to FDA opposing its approval of GE salmon, reportedly the first of some 30 other species of GE fish under development. If approved, the salmon would be the first GE animal in the U.S. food supply, and FDA has indicated that it will likely not be labeled as a product of genetic engineering. See Friends of the Earth News Release, March 3, 2014.  

According to a coalition of environmental organizations, service has been effected on the defendants to their court application challenging the legality of the Canadian government’s decision to allow AquaBounty Technologies to commercially produce genetically engineered (GE) salmon. Ecology Action Centre v. Minister of the Env’t, No. T-2114-13 (Fed. Ct., filed December 23, 2014). They contend that Minister of the Environment Leona Aglukkaq and Minister of Health Rona Ambrose failed to assess under the Canadian Environmental Protection Act whether GE salmon “could become invasive, potentially putting ecosystems and species such as wild salmon at risk.” Alleging several statutory and regulatory violations, the organizations seek a declaration that the ministers acted unlawfully and without jurisdiction, their toxicity assessment is invalid and unlawful, or they unlawfully or unreasonably failed to conduct a lawful and complete toxicity assessment. AquaBounty CEO Ron Stotish has reportedly indicated that the legal action is without merit. See Ecology Action Centre…

Environment Canada has published a significant new activity notice that will allow AquaBounty Technologies, Inc. to produce genetically modified (GM) salmon eggs. According to the company, the agency determined that GM salmon “is not harmful to the environment or human health when produced in contained facilities.” AquaBounty CEO Ron Stotish said, “This is a significant milestone in our efforts to make AquAdvantage® Salmon available for commercial production. However, our eggs and fish will not be available for sale until they are approved by the relevant national regulatory bodies.” The company notes that Environment Canada reached its conclusion “following a risk assessment conducted by Fisheries and Oceans Canada involving a panel of independent scientific experts knowledgeable in the fields of transgenics and fish containment technology.” See Canada Gazette, November 23, 2013; AquaBounty Technologies News Release, November 25, 2013.  

The Food and Drug Administration (FDA) has recently drawn criticism over the delayed release of documents evaluating the environmental impact of genetically engineered (GE) salmon. Created by Massachusetts-based AquaBounty Technologies, the GE salmon in question evidently contain genes from Chinook salmon as well as ocean pout that allow the company to bring the fish to market in half the normal time. After a publicly contentious review process, FDA released the May 4, 2012, draft assessment and a preliminary finding of no significant impact in late December, raising questions among groups such as the Genetic Literacy Project (GLP) about whether the agency froze the application to avoid political turmoil during the election season. “The delay, sources within the government say, came after meeting with the White House, which was debating the political implications of approving the [GE] salmon, a move likely to infuriate a portion of its base,” GLP Executive Director…

Three consumer advocacy organizations have filed a petition with the Office of Food Additive Safety of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition requesting that ABT Technologies’ application to approve genetically engineered (GE) salmon be reviewed under the food additive provisions of the Food, Drug, and Cosmetic Act. The company’s new animal drug application for the GE salmon is currently pending before the agency’s Center for Veterinary Medicine. According to Food & Water Watch, Consumers Union and the Center for Food Safety, the company’s GE process “significantly alters the salmon’s composition . . . in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns. Under the Agency’s regulations and guidelines, such a substance must be treated as a food additive and the Agency must make a closer inquiry into the safety…

Alaska’s U.S. Senators Mark Begich (D) and Lisa Murkowski (R) have introduced two new bills as part of their ongoing campaign to prevent the federal government from allowing the sale of genetically engineered (GE) salmon. Information about related legislative proposals they sponsored in January 2011 appears in Issue 380 of this Update. One new proposal (S. 1717) would make it unlawful for anyone to “ship, transport, offer for sale, sell, or purchase genetically altered salmon or other marine fish, or a product containing genetically altered salmon or other marine fish, in interstate or foreign commerce.” The other proposal (S.A. 751), offered as an amendment to a House appropriations bill (H.R. 2112), would preclude the Food and Drug Administration (FDA) from spending any funds to approve an application for the approval of GE fish. One such application is pending before the agency. According to Begich, “There is just too much at…

A federal court in Maryland has permitted groups representing environmental and fishing interests to intervene in litigation filed by Dow AgroSciences LLC and two other pesticide manufacturers against the U.S. National Marine Fisheries Service (NMFS), seeking to overturn the agency’s opinion that three insecticides threaten the Pacific salmon. Dow AgroSciences LLC v. Nat’l Marine Fisheries Serv., No. 09-00824 (D. Md., order entered August 23, 2011). In March 2011, the Fourth Circuit Court of Appeals determined that NMFS’s biological opinion on the effects of chlorpyrifos, diazinon and malathion was judicially reviewable action under the Administrative Procedure Act, thus allowing the companies, which hold registrations for the insecticides from the Environmental Protection Agency (EPA), to challenge the action before the district court. NMFS apparently provided the biological opinion to EPA in 2008 as part of EPA’s process of reregistering the insecticides for sale and use; they were first registered in the 1950s and…

A coalition of 38 industry organizations has sent a letter to U.S. House and Senate leaders urging Congress to allow the Food and Drug Administration (FDA) to complete its review of an application for genetically engineered (GE) salmon. The coalition’s letter comes on the heels of a recent House-approved appropriations amendment that prohibits FDA from using money in fiscal year 2012 to finalize its review of AquaBounty Technologies’ application to produce fast-growing GE Atlantic salmon and the efforts of a bipartisan group of congressional lawmakers to halt the application’s approval process. According to the “Animal Agriculture Coalition,” if it the amendment becomes law, FDA’s ability to process such applications using best-available science would be diminished, damaging the agency’s credibility “at home and overseas.” Coalition members include the Biotechnology Industry Organization (BIO), whose president and CEO was quoted as saying that “disrupting FDA’s science-based assessment process based on non-scientific political concerns would…

A bipartisan group of lawmakers has called on the U.S. Food and Drug Administration (FDA) to stop the approval process for genetically engineered salmon. Fifteen members of the House of Representatives and eight members of the U.S. Senate signed separate letters to FDA Commissioner Margaret Hamburg expressing economic and environmental concerns over the fast-growing fish. “We are concerned that the FDA’s review of GE salmon uses the same criteria as it would for approving a veterinary drug,” noted the Senate letter, adding that “the lack of transparency in the approval process is extremely disconcerting given that approval of GE fish is likely the first step toward approval of many more GE animals for human consumption.” The House recently approved an amendment prohibiting FDA from using money to approve GE salmon applications in fiscal year 2012 and, according to the letters, similar language has been drafted for consideration by the Senate.…

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