Preparing for a Blue Revolution: Regulating the Environmental Release of Transgenic Fish
By Dorothy W. Bisbee
INTRODUCTION
Forty years ago, Crick and Watson announced their characterization of the DNA double helix, revolutionizing the field of biology. Twenty years later, researchers began cloning genes in their laboratories, and today, with the help of recombinant DNA techniques, biotechnology is a booming industry, already estimated to account for $4 billion per year in annual U.S. sales. The potential commercial gain is tremendous, and the Commerce Department expects American biotechnology companies to gross more than $50 billion by the turn of the century. These companies have predicted that they will be able to produce better drugs and other medical products, improve agricultural production, and clean up the environment. In addition, the U.S. Departments of Energy and Defense are investigating biotechnology applications.
Other potential developments in biotechnology range from the utilitarian to the purely aesthetic. For example, genes responsible for the bioluminescence fireflies produce have been inserted into orchid, corn and tobacco plants. One researcher who has transferred a working firefly gene into a Douglas fir tree cell told a journalist, “We even joke about getting a tree that glows in the dark.” In his novel Jurassic Park, Michael Crichton merely speculates about the creation of “paler trout for better visibility in the stream ... and injectable scent cells so you'll always smell of your favorite perfume.” In reality, researchers are working to genetically engineer fish for increased visibility or desired coloring, and since biotechnologists are now using genetic engineering techniques to cause tobacco plants to produce desired scents, it is conceivable that fragrance genes ultimately could be spliced into human chromosomes. The possibilities for future developments seem limited only by the imagination.
Early genetic engineering technology focused on microorganisms and plants. Among animals, most gene transfer work has been performed on mice for use as model systems for gene expression in vertebrates. Only in the last decade have researchers learned to successfully integrate foreign genes into the chromosomes of fish, aimed at producing strains with traits such as increased cold tolerance and rapid growth rates. The technology is growing quickly, and according to The New York Times, “ s trains of fish that grow bigger faster and are resistant to diseases could spark a ‘blue revolution’....” The process of fish gene transfers will probably be industrialized within five to fifteen years. At that time, significant numbers of genetically engineered, or transgenic, fish may enter natural waterways by escaping from fish farms or by intentional release into natural waters for sport fisheries, bioremediation or other purposes.
Numerous scientists have concluded that genetic engineering is as safe as traditional techniques such as cross-breeding and fermentation. Legitimate questions about the release of transgenic fish remain. Past experience with exotics and hatchery-bred fish has indicated that the introduction of transgenics into natural waters could cause significant and irreversible harm to aquatic ecosystems, and to the economies which depend upon them. Ecological disasters have already occurred following introductions of non-engineered non-native fish. Some scientists fear that engineered fish will cause even greater environmental upsets. And while the risks of catastrophic impact arising from individual introductions of transgenics are thought to be of low probability, the chances of ecosystem disruption will likely grow with the genetic engineering industry. Logically, the greater the variety and scale of releases, the greater the risk that one strain of genetically engineered fish will forever disrupt a broad range of natural aquatic ecosystems.
Transgenic fish pose concerns unique among genetically engineered organisms. Unlike plants or farm animals, fish escape easily, travel rapidly, and reproduce quickly. Once genetically engineered fish have escaped or been introduced into natural waters, they may reproduce and transfer their novel traits to closely related wild species. Conversely, exotic fish generally cannot breed with native fish, and selectively bred fish can only have traits which already existed at some frequency in the species' gene pool. Transgenic fish may in the future express traits which allow them to outcompete other fish, to consume organisms humans consider to be undesirable, or to change their ranges or migration patterns. Because novel traits may be chosen from a wide variety of sources and introduced quickly, transgenic fish may be more likely than selectively bred or exotic fish to cause these adverse effects, jeopardizing existing ecosystems and biological diversity. Furthermore, many people have expressed ethical or religious concerns about the manipulation of the genetic code. The environmental release of the products of this manipulation worries these critics as well as those who would prefer that “natural” environments be preserved.
Given these important concerns about genetic engineering, it is perhaps surprising that there is no regulation which specifically controls the release of transgenic fish. In fact, there is no federal legislation exclusively designed to regulate biotechnology. While a few states have passed laws restricting the release of genetically engineered organisms (GEOs), little federal regulation covers the release of genetically engineered fish or other animals, and most such regulation to date has occurred under pre-existing federal laws not formulated to address genetic engineering.
The best way to understand the federal regulation of biotechnology is to examine the Coordinated Framework for Regulation of Biotechnology, a document produced by the Office of Science and Technology Policy. The Coordinated Framework, completed in 1986, attempts to clarify how particular activities will be regulated and identifies pertinent statutes and the agencies that administer them, including the Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Science Foundation (NSF) and the Occupational Safety and Health Administration (OSHA). Under the Framework, these six agencies are instructed to “seek to operate their programs in an integrated and coordinated fashion and together should cover the full range of plants, animals and microorganisms derived by the new genetic engineering techniques.”
To date, federal regulation of transgenics has focused on plants and microorganisms; minimal provisions have been made to regulate animals. Margaret Mellon, Director of the National Wildlife Federation's National Biotechnology Policy Center, recently observed that “ no comprehensive federal authority exists under which the releases of fish will be reviewed.” Dr. Mellon speculated: “Perhaps because so few engineered animals were under development in the 1980s, the Framework said little about the environmental risks posed by animals. Although a few of the statutes ... could potentially be applied to releases of animals, no attempt has been made to do so.” The only instance in which releases of genetically engineered fish and other animals are currently monitored is where research has received federal funding, generally from the USDA, NIH or NSF. Private industry is under no legal obligation to provide notice of, or to limit, planned or unintentional releases of genetically engineered animals.
While much of the discussion may be applied to the study of biotechnology regulation in general, this Note will specifically consider creating federal regulation of, and policy regarding, the large-scale intentional or unintentional environmental release of transgenic fish and other aquatic organisms prepared by industry. Part II will present background on recombinant DNA techniques as applied to fish, mentioning the possible economic effects of the technology and its moral and ethical significance to industry and the public, and will focus on its potential ecological effects. Part III will present regulatory mechanisms which have been suggested to control ecological risks. Part IV will evaluate the adequacy of the existing federal biotechnology policy and regulations, identifying current or potential applications to transgenic fish, and comparing these provisions to the regulatory needs mentioned in Part III.
Part V of this Note explains the need for public discussion of the risks associated with transgenic fish. This discussion points to the need for a federal policy that will earn public confidence. Part VI proposes the implementation of a federal policy through the issuance of an executive order. This part also provides a sample order that reflects the conclusions reached by this note.
The Conclusion will review the possible ecological risks of releasing genetically engineered fish, and underscore the importance of the technology to the economy and to other interests. Finally, the Conclusion will consider the opportunity the executive and legislative branches have to address planned and accidental introductions of genetically modified aquatic organisms into the environment during the next decade, before they become problematic. If regulatory guidelines are clear at the time that genetic engineering is applied to aquatic organisms on a commercial scale, then the aquaculture industry will be better able to plan corporate strategies, and undesired or unexpected changes in the environment will be less likely to occur. Similarly, managers of fisheries who intentionally stock fish will be able to ensure that information about all releases is collected for future reference, and that planned releases are carefully considered. The sooner these guidelines are developed, the more likely it is that economic and environmental concerns surrounding the release of transgenic fish and other animals can be reconciled with public and private goals.
Forty years ago, Crick and Watson announced their characterization of the DNA double helix, revolutionizing the field of biology. Twenty years later, researchers began cloning genes in their laboratories, and today, with the help of recombinant DNA techniques, biotechnology is a booming industry, already estimated to account for $4 billion per year in annual U.S. sales. The potential commercial gain is tremendous, and the Commerce Department expects American biotechnology companies to gross more than $50 billion by the turn of the century. These companies have predicted that they will be able to produce better drugs and other medical products, improve agricultural production, and clean up the environment. In addition, the U.S. Departments of Energy and Defense are investigating biotechnology applications.
Other potential developments in biotechnology range from the utilitarian to the purely aesthetic. For example, genes responsible for the bioluminescence fireflies produce have been inserted into orchid, corn and tobacco plants. One researcher who has transferred a working firefly gene into a Douglas fir tree cell told a journalist, “We even joke about getting a tree that glows in the dark.” In his novel Jurassic Park, Michael Crichton merely speculates about the creation of “paler trout for better visibility in the stream ... and injectable scent cells so you'll always smell of your favorite perfume.” In reality, researchers are working to genetically engineer fish for increased visibility or desired coloring, and since biotechnologists are now using genetic engineering techniques to cause tobacco plants to produce desired scents, it is conceivable that fragrance genes ultimately could be spliced into human chromosomes. The possibilities for future developments seem limited only by the imagination.
Early genetic engineering technology focused on microorganisms and plants. Among animals, most gene transfer work has been performed on mice for use as model systems for gene expression in vertebrates. Only in the last decade have researchers learned to successfully integrate foreign genes into the chromosomes of fish, aimed at producing strains with traits such as increased cold tolerance and rapid growth rates. The technology is growing quickly, and according to The New York Times, “ s trains of fish that grow bigger faster and are resistant to diseases could spark a ‘blue revolution’....” The process of fish gene transfers will probably be industrialized within five to fifteen years. At that time, significant numbers of genetically engineered, or transgenic, fish may enter natural waterways by escaping from fish farms or by intentional release into natural waters for sport fisheries, bioremediation or other purposes.
Numerous scientists have concluded that genetic engineering is as safe as traditional techniques such as cross-breeding and fermentation. Legitimate questions about the release of transgenic fish remain. Past experience with exotics and hatchery-bred fish has indicated that the introduction of transgenics into natural waters could cause significant and irreversible harm to aquatic ecosystems, and to the economies which depend upon them. Ecological disasters have already occurred following introductions of non-engineered non-native fish. Some scientists fear that engineered fish will cause even greater environmental upsets. And while the risks of catastrophic impact arising from individual introductions of transgenics are thought to be of low probability, the chances of ecosystem disruption will likely grow with the genetic engineering industry. Logically, the greater the variety and scale of releases, the greater the risk that one strain of genetically engineered fish will forever disrupt a broad range of natural aquatic ecosystems.
Transgenic fish pose concerns unique among genetically engineered organisms. Unlike plants or farm animals, fish escape easily, travel rapidly, and reproduce quickly. Once genetically engineered fish have escaped or been introduced into natural waters, they may reproduce and transfer their novel traits to closely related wild species. Conversely, exotic fish generally cannot breed with native fish, and selectively bred fish can only have traits which already existed at some frequency in the species' gene pool. Transgenic fish may in the future express traits which allow them to outcompete other fish, to consume organisms humans consider to be undesirable, or to change their ranges or migration patterns. Because novel traits may be chosen from a wide variety of sources and introduced quickly, transgenic fish may be more likely than selectively bred or exotic fish to cause these adverse effects, jeopardizing existing ecosystems and biological diversity. Furthermore, many people have expressed ethical or religious concerns about the manipulation of the genetic code. The environmental release of the products of this manipulation worries these critics as well as those who would prefer that “natural” environments be preserved.
Given these important concerns about genetic engineering, it is perhaps surprising that there is no regulation which specifically controls the release of transgenic fish. In fact, there is no federal legislation exclusively designed to regulate biotechnology. While a few states have passed laws restricting the release of genetically engineered organisms (GEOs), little federal regulation covers the release of genetically engineered fish or other animals, and most such regulation to date has occurred under pre-existing federal laws not formulated to address genetic engineering.
The best way to understand the federal regulation of biotechnology is to examine the Coordinated Framework for Regulation of Biotechnology, a document produced by the Office of Science and Technology Policy. The Coordinated Framework, completed in 1986, attempts to clarify how particular activities will be regulated and identifies pertinent statutes and the agencies that administer them, including the Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Science Foundation (NSF) and the Occupational Safety and Health Administration (OSHA). Under the Framework, these six agencies are instructed to “seek to operate their programs in an integrated and coordinated fashion and together should cover the full range of plants, animals and microorganisms derived by the new genetic engineering techniques.”
To date, federal regulation of transgenics has focused on plants and microorganisms; minimal provisions have been made to regulate animals. Margaret Mellon, Director of the National Wildlife Federation's National Biotechnology Policy Center, recently observed that “ no comprehensive federal authority exists under which the releases of fish will be reviewed.” Dr. Mellon speculated: “Perhaps because so few engineered animals were under development in the 1980s, the Framework said little about the environmental risks posed by animals. Although a few of the statutes ... could potentially be applied to releases of animals, no attempt has been made to do so.” The only instance in which releases of genetically engineered fish and other animals are currently monitored is where research has received federal funding, generally from the USDA, NIH or NSF. Private industry is under no legal obligation to provide notice of, or to limit, planned or unintentional releases of genetically engineered animals.
While much of the discussion may be applied to the study of biotechnology regulation in general, this Note will specifically consider creating federal regulation of, and policy regarding, the large-scale intentional or unintentional environmental release of transgenic fish and other aquatic organisms prepared by industry. Part II will present background on recombinant DNA techniques as applied to fish, mentioning the possible economic effects of the technology and its moral and ethical significance to industry and the public, and will focus on its potential ecological effects. Part III will present regulatory mechanisms which have been suggested to control ecological risks. Part IV will evaluate the adequacy of the existing federal biotechnology policy and regulations, identifying current or potential applications to transgenic fish, and comparing these provisions to the regulatory needs mentioned in Part III.
Part V of this Note explains the need for public discussion of the risks associated with transgenic fish. This discussion points to the need for a federal policy that will earn public confidence. Part VI proposes the implementation of a federal policy through the issuance of an executive order. This part also provides a sample order that reflects the conclusions reached by this note.
The Conclusion will review the possible ecological risks of releasing genetically engineered fish, and underscore the importance of the technology to the economy and to other interests. Finally, the Conclusion will consider the opportunity the executive and legislative branches have to address planned and accidental introductions of genetically modified aquatic organisms into the environment during the next decade, before they become problematic. If regulatory guidelines are clear at the time that genetic engineering is applied to aquatic organisms on a commercial scale, then the aquaculture industry will be better able to plan corporate strategies, and undesired or unexpected changes in the environment will be less likely to occur. Similarly, managers of fisheries who intentionally stock fish will be able to ensure that information about all releases is collected for future reference, and that planned releases are carefully considered. The sooner these guidelines are developed, the more likely it is that economic and environmental concerns surrounding the release of transgenic fish and other animals can be reconciled with public and private goals.
