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 Washington D.C.-based 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.

“Although the regulatory review system currently in place has been adequate for those biotechnology products that are already on the market, the introduction of genetically modified fish raises questions about capacity,” said Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology. “Regulators will increasingly have to stretch their authority to make old laws and regulations address the evolving next wave of products. We seem to be treading in uncharted legal waters,” noted Rodemeyer.

A type of transgenic fish may be the first genetically engineered animal to undergo regulatory review by the U.S. government. Researchers have experimented with a number of traits, creating numerous potential products such as Atlantic salmon that grow faster than traditional salmon and tilapia which may be a good resource for Factor VII, a compound essential to clotting human blood.

These new genetically modified products have drawn some public controversy: Biotechnology proponents claim transgenic fish may be a cost-effective way to supply an ever-increasing human population with a healthy source of protein. They also believe that biotechnology could reap other benefits such as seafood products with fewer human allergens or fish that have been genetically engineered to allow researchers to examine genetic damage caused by exposure to chemicals.

On the other hand, opponents are particularly concerned about the possible environmental and ecological impacts associated with transgenic fish that might escape from fish farms and mate with wild relatives.

There is currently no official guidance by the federal government on how transgenic fish will be reviewed. At the present time, these products are being regulated under existing statutory authority. Federal biotechnology policy was established in the mid-1980s and it was decided at that time that no new laws were needed to regulate the products of agricultural biotechnology. Instead, in 1986, the Coordinated Framework for Regulation of Biotechnology was established, requiring three federal agencies (the FDA, the Department of Agriculture and the Environmental Protection Agency) to use at least ten different laws and numerous agency regulations and guidelines to address biotechnology products. Each of the laws currently used was developed before the advent of biotechnology products and reflects widely different regulatory approaches and procedures.

“Both the industry and the public crave clarity,” concluded Rodemeyer. “Without a clear and transparent road map for regulation, not only is it difficult for developers to bring new products to market, it is also hard for the public to trust that a careful consideration of risks and benefits is taking place before — not after — new products come to market.”