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Executive Summary of the Genetically Engineered Fish Legal Petitions On May 9, 2001, Friends of the Earth joined a coalition of over 60 petitioners, consisting of consumer and environmental protection organizations along with fishing companies and fishermen, in signing legal petitions filed by the Center for Food Safety with the U.S. Food and Drug Administration ("FDA"), U.S. Department of Interior ("DOI"), U.S. Department of Commerce ("DOC"), U.S. Department of Defense ("DOD"), and U.S. Department of Agriculture ("USDA") demanding a moratorium on the domestic marketing and importation of transgenic fish until FDA adequately addresses the impacts to the environment and human food safety. In addition, the petitions request that each federal agency with jurisdiction over an aspect of aquaculture take regulatory action consistent with the requests in the petition. Currently, there are over thirty-five species of transgenic fish being developed around the world and at least one company, A/F Protein, that is presently requesting approval from the FDA to market transgenic fish to consumers as food. A/F Protein's transgenic fish contains a growth hormone gene from a chinook salmon and an antifreeze protein gene promoter from an ocean pout that keeps the growth hormone active. This transgene is injected into fertilized eggs. Due to the continuous production of the growth hormone gene, these transgenic fish grow as much as ten to thirty times faster than normal salmon. While no federal laws specifically govern the regulation of genetically engineered animals grown for human consumption, the FDA has made the informal decision to regulate transgenic fish under its authority to review new animal drugs. In taking this action, transgenic fish producers must complete a New Animal Drug Application (NADA) and demonstrate the safety and effectiveness of these fish. Any such demonstration of safety must be shown through substantial evidence. Given the potential toxicity, allergenicity, and aquaculture diseases posed by the commercialization of transgenic fish, FDA must adopt a pre-market regulatory review that does not ignore these potential human health safety concerns. Additionally, the petition calls for the FDA to require mandatory labeling for any genetically engineered fish products sold for human consumption. Although FDA has regulatory control over human food safety issues, FDA does not have an expertise in the review of marine ecosystem impacts that will be caused by the introduction of transgenic fish into commercial aquaculture. Therefore, petitioners are also demanding that FDA retain the moratorium until the DOI, DOC, DOD, and USDA address the environmental impacts and implement the necessary regulatory requirements as required by each agency's statutory mandates. Unintended releases of transgenic fish into the world's waters may cause significant impacts to the environment and endangered species. New studies have shown that transgenic fish are more aggressive, eat more food, and will attract more mates than wild fish. In addition, these studies show that although transgenic fish will attract more mates, their offspring will be less fit and less likely to survive. As a result, scientists predict that transgenic fish will cause some species to become extinct within only a few generations. Once one species becomes extinct, other species will likely be affected. There are already 114 species of fish, including Atlantic salmon, that are listed under the Endangered Species Act ("ESA"). Allowing transgenic fish in ocean pens may significantly increase this number of listed species. The following petitions have been filed simultaneously with the FDA petition: A joint petition to DOI and DOC requesting a ban on the commercialization of transgenic fish or in the alternative a ban on the use of ocean pens in accordance with the Endangered Species Act, Lacey Act, Aquatic Nuisance Species Act, and the National Aquaculture Policy Act. A petition to DOD requesting a ban on the use of ocean pens in accordance with the National Environmental Policy Act, Endangered Species Act, and Rivers and Harbors Act. Complete copies of the petition are available on-line at www.gefish.org Contact the FDA Today! Tell them that you don't want GE fish in our waters or on your dinner plate! Tell them to deny commercial approval for Frankenfish! Tell then to keep our environment and our health safe! Please contact John Matheson today at the FDA: |
