GLOFISH, THE FIRST GM ANIMAL COMMERCIALIZED: PROFITS AMID CONTROVERSY The GloFish, a fluorescent red zebrafish sold as a novel pet, has become the first transgenic animal sold to U.S. consumers. Its sale has produced regulatory controversies, a lawsuit, and profits for its proponent, Yorktown Technologies (Austin, TX). With the market plan calling for sales in a widening number of countries, continuing controversy seems likely. What is a GloFish? The GloFish is a trademarked transgenic zebrafish (Danio rerio) expressing a red fluorescent protein from a sea anemone under the transcriptional control of the promoter from the myosin light peptide 2 gene ofProduced and patented by a group at the National University of Singapore, exclusive rights for international marketing were purchased by Yorktown Technologies approximately a year-and-a-half ago. through contracts with 5-D Tropical (Plant City, FL) and Segrest Farms (Gibsonton, FL), and began marketing them in

the United States in December. The prospect of commercial sales of GloFish raised a number of issues. Among them was the issue of whether GloFish pose an environmental hazard. tropical species native to south Asia, are sensitive to lowDespite decades of production and use in the U.S., zebrafish have not established self-sustaining populations within the country. fish tank small filter tests1 showed that viability, reproductive success, and temperature toleranceaquarium fish at top of tank of transgenics were equal to or somewhat less than thosecool fish tank decorations ideas of the wild type. used fish tanks for sale in albuquerque

While preliminary, results supported the expectation that the modification would not increase invasiveness, and that environmental risk was small. Commercialization of the GloFish in the United States poses regulatory uncertainty because existing biotechnology policy bases oversight on the use of the product. Sales of ornamental fishes are not federally regulated. fish tanks for mollies Food and Drug Administration asserts jurisdiction overbest fish tanks for goldfish genetically modified animals using the New Animal Drugfish tank shops in derbyAfter a brief internal review andused fish tanks in essex

interagency consultation, FDA's Center for Veterinary Medicine determined that "because tropical aquarium fish are not used for food purposes, they pose no threat to theThere is no evidence that these genetically engineered zebra danio fish pose any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States. jellyfish tank buy uk the absence of any clear risk to the public health, the FDA finds no reason to regulate these particularAlan Blake, CEO of Yorktown Technologies, also made contact with the U.S. Department of Agriculture, the U.S. Fish and Wildlife Service, and the Environmental Protection Agency, which expressed no regulatory concerns States generally have lead authority on fisheriesCalifornia is the only state that forbids the possession, sale, and transport of genetically modified fishes.

Yorktown asked for an exemption, but on December 3, the California Fish and Game Commission voted not to approve saleExplaining the decision, Commissioner Sam Schuchat wrote, "Creating a novelty pet is a frivolous use of this technology. No matter how low the risk is, there needs to be a public benefit that is higher thanMany California consumers were unhappy withFollowing appointment of a new commissioner and a change of mind by a continuing commissioner, on April 1 the Fish and Game Commission reversed their earlier decision by a 3-1They asked for an updated recommendation from the Department of Fish and Game and will hold public hearings before making a final decision. The final vote of the Commission is expected near the end of June. would become available for sale in California by the end of July. Commercialization of GloFish sparked legal action to force the FDA to exert regulatory oversight and blockOn January 14, the Center for Technology

Assessment (CTA) and Center for Food Safety (CFS) filed a lawsuit in the Federal District Court in Washington, D.C. challenging FDA's implementation of the Federal Food, Drug, and Cosmetics Act (FFDCA), National Environmental Policy Act (NEPA), and Administrative Procedures Act regarding procedures by which FDA allowed commercialization of GloFish5. CTA and CFS allege that FDA inaction poses harm to the enjoyment of natural waters, harm to carnivorous fishes, increased exposure to antibiotic-resistant bacteria and viruses due to elements in the expression vector used to produce GloFish, and aesthetic injury from viewing genetically engineered GloFish in aquaria. CTA and CFS asked the court to declare that FDA has regulatory authority under FFDCA, "absence of a clear risk to public health" is not the appropriate regulatory standard, and FDA action was not compliant with NEPA, and to enjoin FDA from allowing further sales of GloFish.

The lawsuit is currently pending. Future prospects for the GloFish include marketing additional color lines in a wider range of markets. red, but also green and yellow fluorescent proteins have been introduced into stable transgenic lines, yielding green, yellow, and orange fish. Commercialization of fluorescent zebrafish has gone forward in several countries and is stymied inFluorescent green zebrafish developed in Taiwan have been sold in Taiwan, Malaysia, and Hong Kong. Singapore confiscated attempted imports of the fish. this, Yorktown Technologies is considering other markets, including parts of Asia and Latin America. Extensive information requirements suggest that GloFish will not be marketed in Canada or the European Union in theDespite these regulatory challenges, according to Blake, "The GloFish venture is a profitable one, and the company looks forward to continuing to provide a safe and enjoyable product for many years to come."

Issues posed by commercialization of GloFish will be with us for years to come. other transgenic fishes, including Atlantic salmon expressing an introduced growth hormone (GH) gene, has beenGH-transgenic tilapia, channel catfish, and rainbow trout are on the regulatory horizon, and a wide range of other transgenic fishes are under development. of fluorescent zebrafish may spur efforts to develop other transgenic ornamentals, such as goldfish and koiTransgenic zebrafishes also are under development for biomoni-toring—expression of fluorescent protein genes under the control of estrogen-inducible or stress response promoters would indicate exposure of caged zebrafish 1. Gong W et al. (2003) Development of transgenic fish for ornamental and bioreactor by strong expression of fluorescent proteins in the skeletal muscle. Biophysical Research Communications 308: 58-63. 2. U.S. Food and Drug Administration. 3. Schuchat S. (2003) Why GloFish won't glow in California.