Future Fish: Issues in Science and Regulation of Transgenic Fish

Pew Initiative on Food & Biotechnology , January 2003

Over the past decade, genetic engineering has emerged as one of the most powerful transforming technologies known to this generation. Scientists can now transfer the beneficial traits of a particular gene from one organism to another in far less time than needed in traditional breeding and with more precision. The application of genetic engineering to agriculture already makes it easier for farmers to grow certain crops and reduces the use of certain pesticides.

But this technology has also triggered debate among scientists, philosophers, environmental advocates, public health officials, business leaders, and regulators over a range of issues—from environmental safety and ecological impacts to the ethics of altering a genome.

It is unclear whether the approach currently being used by government regulators gives them the tools to effectively evaluate environmental issues surrounding transgenic (genetically modified) fish, according to Future Fish: Issues in Science and Regulation of Transgenic Fish, a new report released today by the Pew Initiative on Food and Biotechnology.

The report, which provides an overview of current research efforts to apply genetic engineering technology to aquaculture and discusses the food safety and environmental issues associated with transgenic fish, carefully examines FDA’s proposed plan to evaluate transgenic fish through the same process the Agency uses to evaluate new animal drugs. Although the new animal drug application (NADA) process appears to give FDA adequate legal authority and risk management tools to evaluate potential food safety concerns associated with transgenic fish, the report finds that FDA may not be equally empowered to address the environmental and ecological concerns some associate with genetically modified (GM) fish. Specifically, the report questions whether the Agency’s review process provides the necessary levels of transparency and public participation needed to ensure public confidence, and asks whether the Agency has the expertise, authority and resources necessary to conduct a comprehensive review of transgenic fish.

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