Biological Confinement of Genetically Engineered Organisms (2004) / Chapter Skim
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2. When and Why to Consider Bioconfinement
2. When and Why to Consider Bioconfinement
Pages 29-64
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As most traditionally improved organisms pose few safety problems that require confinement, it is likely that most of the vast array of proposed genetically engineered organisms (GEOs) will pose little threat to public health or the environment, and they will require minimal confinement, if any.
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WHAT IS RISK? In many aspects of its deliberations, the Committee on the Biological Confinement of Genetically Engineered Organisms found it necessary to discuss "hazard," "harm," and "risk." The terminology used here is consistent with past reports of the National Research Council (NRC, 1983, 1996, 2002b)
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. Without cumulative risk analysis, it is impossible to assess the hazard associated with bioconfinement failure.
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. The committee recognizes those earlier discussions and suggests it would be useful to describe a systematic approach to risk assessment and management, without delving into the issue of risk characterization other than to note its relevance and importance, particularly with respect to transparency and public participation.
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How well established is the knowledge used to identify the hazard, estimate its risk, and predict harms? Risk reduction What can be done (including bioconfinement and other planning and confinement)
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. In September 2000, the Washington Post reported that traces from transgenes of StarLink corn had been detected in the human food supply by an independent laboratory for Genetically Engineered Food Alert, a coalition of environmental and food safety organizations (Kaufman, 2000)
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. "Concern" is used here to mean an "uneasy state of interest, uncertainty, and appre The potential sources of the widespread presence of StarLink material in the human food supply are many.
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Potential Effects Genetically engineered organisms are controversial. Dozens of scholarly reports have identified, reviewed, and evaluated the realized and potential effects of their use, particularly transgenic crops and fish (e.g., Carpenter et al., 2001; Colwell et al., 1985; Cook et al., 2000; Dale et al., 2002; Hails, 2000; Kapuscinski and Hallerman, 1991, 1994; Keeler and Turner, 1990; Marvier, 2001; McHughen, 2000; NRC, 1989b, 2000, 2002a, 2002b; Pew Initiative on Food and Biotechnology, 2003; Rissler and Mellon, 1996; Scientists' Working Group on Biosafety, 1998; Snow and Moran-Palma, 1997; Tiedje et al., 1989; Traynor and Westwood, 1999; Winrock International, 2000; Wolfenbarger and Phifer, 2000)
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. The list of potential benefits attributable to transgenic plants, animals, and microorganisms is long and diverse, and it is difficult to name all of the beneficial phenotypes that have been proposed for transgenic organisms.
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. There is no data yet, however, to suggest that the rate of horizontal transfer would be any faster for transgenic organisms (Syvanen, 2002)
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Atlantic salmon Increased growth rate and food Aquaculture Method has conversion efficiency after for human been patented; insertion of Chinook salmon food seeking Food growth hormone gene that and Drug operates year-round, thereby Administration fostering steady growth through approval the year rather than summer growth (Cook et al., 2000; Hew and Fletcher, 1996) Red sea bream Increased growth rates after Aquaculture Research insertion of an "all fish" growth for human hormone consisting of ocean food pout antifreeze protein gene promoter and Chinook salmon growth hormone (Zhang et al., 1998)
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Carp Improved disease resistance after Aquaculture Research insertion of a human interferon for human gene (Zhu, 2001) food Goldfish Increased cold tolerance after Aquaculture Research insertion of ocean pout antifreeze for human protein gene (Wang et al., 1995)
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. Oysters Improved disease resistance by Aquaculture Research introduction of retroviral vectors.
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Kuruma prawns Potential improved growth rate Aquaculture Research through gene insertion. for human Researchers are currently food inserting marker genes to confirm most appropriate method (Preston et al., 2000)
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Plum Resistance to plum pox virus Fruit Release permit using capsid gene (Ravelonandro production issued et al., 1998) Bartlett pear Resistance to fireblight bacterial Fruit Field tested disease conferred by a synthetic production under APHIS antimicrobial gene (Puterka et notification al., 2002)
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(De Leij et al., indigenous 1995) microbial populations in wheat Fluorescent Chromosomal insertion of lacZ To monitor Field testing pseudomonads and Kanr (De Leij et al., 1995)
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plants Aspergillus niger Production of bovine chymosin Cheesemaking Commercial Colletotrichum Virulence to weeds Mycoherbicide Research and coccodes development Escherichia coli Production of human insulin by Treatment of Commercial cloned gene diabetes in production humans Insects Cochliomyia GFP in PiggyBac (transposon Improved Research hominovorax that inserts gene sequence of a pest control desired trait in the TTAA gene sequence of the insect) (Handler and Allen, unpublished)
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competence Pectinophora Fluorescent proteins in PiggyBac Improved Research and gossypiella (Peloquin et al., 2000) pest control, field trials heterologous protein expression in mass-reared insects Anastrepha Fluorescent proteins in PiggyBac Improved Research suspensa (Handler and Harrell, 2001)
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. Virtually all farmed fish and shellfish lines can breed readily with other captive lines and with wild relatives.
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A basic understanding of gene dispersal and the fitness effects of specific transgenes is essential for evaluating whether bioconfinement is needed and for developing effective bioconfinement methods. The committee intentionally did not hazard to guess what the fitness effects of classes of transgenes might be in recipient populations because it is already clear that generalizations might be difficult to obtain.
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The first is whether transgenes will confer a benefit to the transformed organism itself or to weedy or invasive relatives, resulting in the evolution of weeds that are difficult to control or in the evolution of new invasive lineages that overrun and disrupt natural ecosystems. The second issue is the question of whether the wild relatives of transgenic organisms will suffer an increased risk of extinction because of hybridization with or competition from those organisms.
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. If transgenes confer the ability to overcome factors that limit wild populations, the resultant genotype might be significantly more weedy or invasive than is its nontransgenic progenitor.
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. Crops that are engineered to produce pharmaceutical or other industrial compounds can cross-pollinate with the same species grown for human consumption, with the unanticipated result of new chemical components in the human food supply (Ellstrand, 2003b)
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. Nonetheless, if transgenes or transgenic organisms designed to be toxic to pests or pathogens move into locations or populations for which they were not intended, they could harm organisms other than the intended pest species.
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WHEN AND WHY TO CONSIDER BIOCONFINEMENT: THE NEED FOR PREVENTIVE ACTION It is essential to consider preventive action before a failure occurs and even before confinement techniques are chosen. Prevention typically is less expensive and more effective than is remedial action, and some consequences -- death of a human, extinction of a species, destruction of a large ecosystem -- cannot be reversed.
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In some cases, appropriate confinement might be obtained by conventional, non-biological, methods. For example, sufficient isolation might be achieved by growing a minor crop far from stands of the same variety and away from populations of wild relatives.
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The appropriate amount of confinement might be possible now, but the method could be so expensive as to preclude its use. Bioconfinement methods offer an opportunity to expand the number and diversity of tools available.
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In any case, regulatory agencies have seen that granting approval to genetically engineered plants that are intended solely for animal consumption is inadvisable if other varieties are used in human food production. PREDICTING THE CONSEQUENCES OF FAILURE Failure of bioconfinement presents several challenges.
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The StarLink incident led to the realization that current systems do not provide for the segregation of genetic material. A flurry of attention from the popular media about a bioconfinement method that fails could result in similar public mistrust for methods that are designed to keep transgenes in their place, leading to a loss of public confidence in the food supply and damage to the viability of the biotechnology industry as a whole.
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that could be affected by an escape or by any resulting loss of public confidence; insurance companies; government regulators; and private citizens who might sue to enforce environmental laws. Decisions about private legal action arising from damage caused by GEOs might indirectly affect whether bioconfinement or other confinement measures are undertaken.
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food supply. After the Prodigene incident, the Grocery Manufacturers of America met with senior USDA officials and congressional staff members to call for stricter regulation of pharmaceutical crops (Fox, 2003)
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Determining which law applies to a GEO under the coordinated framework can entail a complicated analysis, involving such factors as the stage of development (Is the GEO contained in the laboratory? Is it being field tested?
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APHIS, for example, requires physical confinement where crops genetically engineered to produce industrial chemicals or pharmaceuticals are field tested. The confinement requirements include a 50-ft perimeter fallow zone around the field test site; restriction on the production of food and feed crops in the field test site and in the fallow zone the next season if volunteer plants could be inadvertently harvested with that season's crop; the use of dedication of mechanical planters and harvesters for the duration of the test, and cleaning of that equipment in accordance with protocols for tractors and tillage attachments; the use of dedicated facilities for storing equipment and the regulated GEO; and, for field tests of open-pollinated pharmaceutical corn, a prohibition against growing any other corn one mile of the field test site for the duration of the field test (Federal Register, 2003)
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. The regulatory system described above is obviously complex, leading to differing legal authorities and responsibilities, potentially overlapping jurisdictions, and differing statutory standards for regulating GEOs and determining confinement (including bioconfinement)
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Private Action for Damage An indirect decision maker about bioconfinement is found in private causes of action for compensation for damage that results from escape, which typically would be subject to state law. One example with respect to nonbiological confinement is a class action lawsuit brought by farmers who claimed they were harmed when StarLink corn was discovered in the human food supply in 2000.
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64 BIOCONFINEMENT OF GENETICALLY ENGINEERED ORGANISMS confinement (Monsanto Canada Inc. & Monsanto Co.
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