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As the U.S. Food and Drug Administration (FDA) considers approving a genetically modified (GM) Atlantic salmon (Salmo salar), it faces fundamental questions of risk analysis and impact assessment. The GM salmon-whose genome contains an inserted growth gene from Pacific chinook salmon (Oncorhynchus tshawytscha) and a switch-on gene from ocean pout (Zoarces americanus)-would be the first transgenic animal approved for human consumption in the United States (1, 2). But the mechanism for its approval, FDA's new animal drug application (NADA) process (2), narrowly examines only the risks of each GM salmon compared with a non-GM salmon (2, 3). This approach fails to acknowledge that the new product's attributes may affect total production and consumption of salmon. This potentially excludes major human health and environmental impacts, both benefits and risks. Regulators need to consider the full scope of such impacts in risk analyses to avoid unintended consequences (4), yet FDA does not consider ancillary benefits and risks from salmon market expansion (2, 3), a result of what may be an overly narrow interpretation of statutes.

"In some cases, cheaper types of fish were substituted for expensive species. In others, fish that consumers have been urged to avoid because stocks are depleted, putting the species or a fishery at risk, was identified as a type of fish that is not threatened. Although such mislabeling violates laws protecting consumers, it is hard to detect. Some of the findings present public health concerns. Thirteen types of fish, including tilapia and tilefish, were falsely identified as red snapper. Tilefish contains such high mercury levels that the federal Food and Drug Administration advises women who are pregnant or nursing and young children not to eat it."

a compelling reason to publish negative results.

Northeast - Red Tide/Shellfish Closure Extension Through December 31, 2011 At the request of the U.S. Food and Drug Administration, NOAA Fisheries Service has extended the temporary paralytic shellfish poisoning (PSP) closure through December 31, 2011, due to the presence of high levels of the toxin that causes PSP. See a chart of the closure area. NOAA Fisheries Service may terminate the emergency regulations at an earlier date by publishing a notice of termination in the Federal Register if information becomes available indicating such action is warranted.