A team of researchers at Duke University has published an article criticizing the FDA methodology for the approval of GE (Genetically Engineered) Atlantic Salmon.

The article was published in the November 19 issue of Science. Due to copyright restrictions we cannot attach the full text of the article. However, we include the summary below. Readers with university or other institutional affiliations can obtain copies on the HighWire Press electronic journals service.

Genetically Modified Salmon and Full Impact Assessment, Smith, Ascher, et al., Science, vol. 330,  no. 6007, pp. 1052-1053, 19 November 2010


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. But the mechanism for its approval, FDA's new animal drug application (NADA) process, narrowly examines only the risks of each GM salmon compared with a non-GM salmon. 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, yet FDA does not consider ancillary benefits and risks from salmon market expansion, a result of what may be an overly narrow interpretation of statutes.

See other postings on this subject below - August 26, September 3 & 29, and October 15.