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Biological Confinement of Genetically Engineered Organisms (2004)
Board on Agriculture and Natural Resources (BANR)
 Board on Agriculture (BOA)
 Board on Life Sciences (BLS)

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. "Index." Biological Confinement of Genetically Engineered Organisms. Washington, DC: The National Academies Press, 2004.

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Index A Asexually produced seeds, 81­83 Ashby Committee, 20 Abandoned methods, 152­153 Auxotrophy, 111­112 Action Group on Erosion, Technology, and Aventis CropScience, 24, 34 Concentration, 25 Adequacy of confinement, 54­55 Advisory Board for the Research Councils, B 20 Agricultural Research Service, 25 Bacteria Allopolyploids, chromosomal locations in, bioconfinement of, 169­179 88­90 displacement of indigenous Animal and Plant Health Inspection Service populations, 164­165 (APHIS), 24, 36, 54, 56, 115 horizontal genetic transfer into local Animal Biotechnology: Science-based populations, 167­168 Concerns, 35 invasion into indigenous populations, Animals 162­164 bioconfinement of, 130­158 phenotypic handicapping, 170­172 methods of bioconfinement, 4­5 suicide genes, 173­174 Antifertility genes, 23 BANR. See Board on Agriculture and APHIS. See Animal and Plant Health Natural Resources Inspection Service Barriers Apomixis (asexually produced seeds), 81­83 physical, 16 strengths, 82 physiochemical, 16­17 weaknesses, 83 Berg, Paul, 19 Aqua Bounty Farms, 137­138 Bio-barcodes, 10 Artificially induced transgene expression, Bioconfinement, 180­185 84­85 adequacy of, 54­55, 184 strengths, 85 case-by-case evaluation, 180­181 weaknesses, 85 changes of efficacy with scale, 184 245

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246 INDEX compliance, 190­191 unacceptability of some methods cost of compliance, 192­193 under some circumstances, 185 defined, 15­16 verification, monitoring, and the defining risk, 30­35 efficacy of confinement, 191 delaying the evolution of resistance, Bioconfinement of animals, 130­158 52­53 bioconfinement of fish and shellfish, early evaluation, 181­182 132­153 effects on nontarget species, 52 bioconfinement of insects, 153­158 ensuring efficacy of, 6­10 Bioconfinement of bacteria, viruses, and experimental information on efficacy, fungi, 160­179 183­184 displacement of indigenous food safety and other issues, 53 populations, 164­165 history of, 19­25 ecosystem and population effects, and human error, 191­192 177­178 increases in spatial and temporal effectiveness of methods at different scale, 193 temporal and spatial scales, 176­ increasing the efficacy of, 189­193 177 natural events, 192 failed or inappropriate methods of necessary for trees, 105­106 microbial bioconfinement, 176 need for, 55­56 fitness reduction, 169­176 need for preventive actions, 53­54 horizontal genetic transfer into local options based on technology and populations, 165­169 gene-specific compounds, 185 invasion into indigenous populations, predicting the consequences of failure, 161­164 56­58 microalgae, 179 private litigation, 193 monitoring, detection, and culling-- rationale for, 3­4 needs, feasibility, and realities, redundancy, 182­183 178 transparency and public participation, Bioconfinement of fish and shellfish, 132­ 189­190 153 unacceptability of some methods abandoned and inappropriate under some circumstances, 185 methods, 152­153 when and why to consider, 29­64 combining triploidization with who decides, 58­64 interspecific hybrids, 152 Bioconfinement concerns, 35­52 disruption of sexual reproduction, about field-released GEOs, 48­52 132­145 gene dispersal and persistence, 38­48 gene blocking and gene knockout, potential effects, 36­38 145­151 Bioconfinement failure, 194­195 naturally sterile interspecific hybrids, detecting and mitigating, 10­11 151­152 failed or inappropriate methods of Bioconfinement of insects, 153­158 microbial, 176 ecological characteristics of managing, 124­129 production site, 157­158 predicting the consequences of, 56­58 fitness reduction and regulation of StarLink corn, 34 gene expression, 158 Bioconfinement methods, 4 sterile insect technique, 153­156 in animals, 4­5 transgenic sterile insects, 156­157 in microbes, 5­6 Bioconfinement of plants, 65­129 in plants, 4, 66­68 effectiveness at different spatial and social acceptability of, 25­28 temporal scales, 122­124 for transgenic turfgrasses, 120­121 genetically engineered trees, 98­114

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INDEX 247 methods of bioconfinement, 65­97 Chromosomal locations in allopolyploids, monitoring and managing 88­90 confinement failure, 124­129 weaknesses, 90 Bioconfinement of pollen-mediated spread Citizen suits, to enforce environmental of transgenes, 76­83 laws, 63 apomixis (asexually produced seeds), Clean Water Act, 63 81­83 Cleistogamy (closed flowers), 81 cleistogamy (closed flowers), 81 strengths, 81 nontransgenic male sterility, 76­77 weaknesses, 81 transgenes in chloroplast DNA, 79­81 Committee on Biological Confinement of transgenic male sterility, 77­78 Genetically Engineered Bioconfinement of transgenes in trees, Organisms, 2, 30, 130 outlook for, 113­114 Community effects, 126­129 Bioconfinement of trees, 98, 104­106 Competition, heightened, 141 Bioconfinement redundancy, 17 Compliance Biological and operational considerations cost of, 192­193 for bioconfinement, 180­198 and the efficacy of confinement, 190­ bioconfinement failure, 194­195 191 execution of confinement, 185­193 Concerns, 35­52 international aspects, 193­194 about field-released GEOs, 48­52 looking to the future: strategic public about gene dispersal and persistence, investment in bioconfinement 38­48 research, 195­198 about potential effects, 36­38 "Biological containment," 20 See Bioconfinement concerns BLS. See Board on Life Sciences Confidential business information (CBI), 62 Board on Agriculture and Natural Confinement. See Bioconfinement Resources (BANR), 2 Consequentialism, and public acceptance, Board on Life Sciences (BLS), 2 27­28 Brenner, Sydney, 20 Constraints, 110­113 fitness handicaps, 112 gene silencing, 111­112 C plastid engineering, 113 sterility, 110­111 Case-by-case evaluation, 180­181 tissue-specific expression, 112­113 recommendation to evaluate each triploidy, 111 GEO separately, 181 Consultative Group on International CBI. See Confidential business information Agricultural Research, 26 Changes of efficacy with scale, 184 Conway, Gordon, 26 recommendation to assess Cooperative Research and Development bioconfinement techniques with Agreement (CRADA), 25 reference to temporal and spatial Coordinated Framework for the Regulation scales of field release, 184 of Biotechnology, 1, 59­60 Channeling, Identity Preservation and the Cost of compliance, and the efficacy of Value Chain: Lessons from the confinement, 192­193 Recent Problems with StarLink CRADA. See Cooperative Research and Corn, 35 Development Agreement 1776, 172 Cross-incompatibility, 88 Chloroplast-targeting gene expression, 93 strengths, 88 Choices weaknesses, 88 of alternative organisms or Cry9C gene, 24, 56 "abstinence," 96­97 Culling, needs, feasibility, and realities, 178 not to proceed, 97

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248 INDEX D Ecosystem effects, 126­129, 177­178 Effectiveness of methods, at different Decision making, 185­186 temporal and spatial scales, 122­ Decisions about when and why to consider 124, 176­177 bioconfinement, 58­64 ELISAs. See Enzyme-linked immunosorbent citizen suits to enforce environmental assays laws, 63 Environmental effects of confinement government, 59­63 failure, recommendation to industry, 58­59 support additional scientific insurance companies, 59 research to assess, 196 private action for damage, 63­64 Environmental Effects of Transgenic Default gene blocking by interference RNA Plants, 31 and exogenous rescue, 149 Environmental laws, citizen suits to strengths, 149 enforce, 63 weaknesses, 149 Environmentally sound bioconfinement, Delta and Pine Land Company, 23, 25 recommendation to support Detection, needs, feasibility, and realities, additional scientific research to 178 develop, 196 Detection technology, 187­189 Enzyme-linked immunosorbent assays recommendation to develop easily (ELISAs), 125 identifiable markers, 187­189 Eradication or control of escaped Dispersal biology of organisms targeted for organisms, 189 genetic engineering and release, Ethical factors influencing application and recommendation to support regulation of particular additional scientific research to techniques, 197 develop better understanding of, Evaluation, early, 181­182 197 Evolutionary persistence of transgenes, Dispersal of transgenes, concerns about, concerns about, 47­48 38, 46­47 Excision of transgenes before reproduction, Displacement of indigenous populations, 84 164­165 strengths, 84 bacteria, 164­165 weaknesses, 84 viruses, 164 Execution of confinement, 185­193 Disruption of sexual reproduction, 132­ decision making, 185­186 145 eradication or control of escaped organisms, 189 increasing the efficacy of confinement, E 189­193 Early cell division, normal steps in, 134 integrated confinement system, 186­ 187 Early evaluation, 181­182 recommendation to consider the need monitoring and detection technology, for bioconfinement early in the 187­189 research, 186 development of a GEO or its products, 182 Experimental information on efficacy, 183­ Ecological characteristics, of production 184 recommendation to compare the novel sites, 157­158 Ecological consequences, of large-scale use genotype with its progenitor of bioconfinement, 11­13 before field release, 183­184 recommendation to test confinement Economic factors influencing application and regulation of particular techniques before putting them techniques, 197 into application, 183

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INDEX 249 Externally administered gene-specific G compounds, 149­150 strengths and weaknesses, 150 Gamete fertilization, normal steps in, 134 Extinction of wild taxa, concerns about, GE. See Genetically engineered species 50­51 Gene blocking, 145­151 default gene blocking by interference RNA and exogenous rescue, 149 F externally administered gene-specific compounds, 149­150 Failure. See Bioconfinement failure genetic bioconfinement strategies for Farmer reluctance, 141 fish, 147 Federal Food, Drug, and Cosmetics Act inducible transgenic gene blocking or (FFDCA), 61 misexpression, 146­148 Federal Insecticide, Fungicide, and Gene dispersal and persistence, 38­48 Rodenticide Act (FIFRA), 62 evolutionary persistence of transgenes, Festuca arundinacea, 119 47­48 Field release choice, 96­97 genetically engineered organisms, 39 Field-released GEOs, 48­52 how transgenes disperse, 38, 46­47 extinction of wild taxa, 50­51 Gene expression gene flow to other domesticated flower- and fruit-specific, 94­95 organisms, 50­51 roots and tuber-specific, 93­94 weediness or invasiveness, 49­50 Gene flow Field Testing Genetically Modified from genetically engineered Organisms, 160 organisms, 4 First International Symposium on to other domesticated organisms, Sustainable Fish Farming, 23 concerns about, 50­51 Fish, bioconfinement of, 132­153 potential for, 118­120 Fitness handicaps, 91­93, 112 Gene knockout, 150­151 strengths, 92 strengths and weaknesses, 150­151 weaknesses, 92­93 Gene silencing, 103, 111­112 Fitness reduction, 169­176 Gene Tools, 150 1776, 172 Genetic bioconfinement, strategies for fish, phenotypic handicapping, 169­173 147 and regulation of gene expression, "Genetic use restriction technologies" 158 (GURTs), 26 strengths, 91 Genetically Engineered Food Alert, 24 suicide genes, 173­176 Genetically engineered species, 17 in transgenic crop-wild progeny, 90­ Genetically engineered organisms, 1 91 concerns about, 39 weaknesses, 91 current and future, 36­38 Flavr SavrTM tomato, 36 defined, 14­15 Flower- and fruit-specific gene expression, finfish, 39­41 94­95 gene flow from, 4 Food safety issues, 53 insects, 45 Fungi marine microorganisms, 42 bioconfinement of, 169­179 marine plants, 41­42 horizontal genetic transfer into local microbes, 44­45 populations, 168­169 mollusks, 41 invasion into indigenous populations, terrestrial plants, 42­44 161­162 Genetically engineered trees, 98­114 phenotypic handicapping, 172­173 bioconfinement of, 98, 104­106 suicide genes, 174­175

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250 INDEX future necessity of biological Inducible transgenic gene blocking or confinement for trees, 105­106 misexpression, 146­148 options and constraints, 110­113 strengths, 147­148 outlook for bioconfinement of weaknesses, 148 transgenes in trees, 113­114 Industry, decision-making about risks of most concern with trees, 106­ bioconfinement, 58­59 110 Influences on the application and stability of transgenic confinement, regulation of particular 102­103 techniques, recommendation to Genetically engineered turfgrasses, 115­ support additional scientific 120 research to identify, 197 bioconfinement methods for, 120­121 Information, right of the public to, 10 difficulty of confinement, 120 Insects potential for gene flow, 118­120 bioconfinement of, 153­158 wild hybrid, Festuca arundinacea and subjected to the sterile insect Lolium multiflorum Lam., 119 technique, 155 Geographic Information System Instability of transgene expression, 110 technology, 183 Insurance companies, decision-making GEOs. See Genetically engineered about bioconfinement, 59 organisms Integrated confinement system (ICS), 8, 34, GFP. See Green fluorescent protein (GFP) 186­187 Government, decision-making about recommendation to use an ICS bioconfinement, 59­63 approach for GEOs that warrant Green fluorescent protein (GFP), 114, 156, confinement, 187 162 Intellectual property rights, 26 Green-specific (chloroplast-targeting) gene International aspects, 19, 193­194 expression, 93 recommendation to consider potential GURTs. See "Genetic use restriction effects of a confinement failure technologies" on other nations, 194 recommendation to pursue international cooperation to H adequately manage confinement of GEOs, 194 Horizontal genetic transfer, 38, 165­169 Interspecific hybrids, 69 bacteria, 167­168 strengths, 69 fungi, 168­169 weaknesses, 69 viruses, 166 Invasion biology, recommendation to HR. See Hypersensitive response support additional scientific Human error, 191­192 research to develop better and the efficacy of confinement, 191­ understanding of, 197­198 192 Invasion into indigenous populations, 161­ recommendation to take into account 164 when determining bacteria, 162­164 bioconfinement methods and fungi, 161­162 evaluating their efficacy, 192 viruses, 161 Hybrids, interspecific, 69 Invasiveness, concerns about, 49­50 Hypersensitive response (HR), 75 L I Leakage, 80 ICS. See Integrated confinement system

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INDEX 251 Legal factors, influencing application and NIH. See National Institutes of Health regulation of particular Nongovernmental organizations (NGOs), techniques, 197 20, 25 Lolium multiflorum Lam., 119 Nontarget organisms, effects on, 107­108 Nontarget species, effects on, 52 Nontransgenic male sterility, 76­77 M Nontransgenic scions on transgenic rootstock, 83­84 Managing confinement failure, 124­129 strengths, 83 population, community, and weaknesses, 83­84 ecosystem effects, 126­129 Methods of bioconfinement. See Bioconfinement methods O Microalgae, 179 Microbes, 5­6 Office of Management and Budget, 61 Monitoring Oliver, Melvin, 23 difficulty of, 11 Operational considerations, for needs, feasibility, and realities, 178 bioconfinement, 180­198 Monitoring confinement failure, 124­129 Options for bioconfinement of plants, 110­ Monitoring technology, 187­189 113 Monsanto, 23, 26, 115 based on technology and gene-specific Mortality of vegetative propagules, 75­76 compounds, 185 strengths, 76 fitness handicaps, 112 weaknesses, 76 gene silencing, 111­112 Mosaic individuals, 140 plastid engineering, 113 sterility, 110­111 tissue-specific expression, 112­113 N triploidy, 111 Organism choice, 96 National Academy of Sciences (NAS), 20, 160 National Endangered Species Act, 63 P National Environmental Policy Act (NEPA), 22, 62­63 Permits approved by APHIS for field tests National Institutes of Health (NIH), 20­22 in the United States Recombinant DNA Advisory genetically engineered turfgrass, 116­ Committee, 21­22 117 National Marine Fisheries Service, 62 genetically engineered turfgrasses, National Research Council, 31 116­117 Board on Agriculture and Natural genetically engineered woody plants, Resources, 2 99­102 Board on Life Sciences, 2 Phenotypic handicapping, 91­93, 169­173 Natural events, and the efficacy of bacteria, 170­172 confinement, 192 fungi, 172­173 Naturally sterile interspecific hybrids, 151­ strengths, 92 152 viruses, 169­170 strengths, 151 weaknesses, 92­93 weaknesses, 151­152 Physical barriers, 16 NEPA. See National Environmental Policy Physiochemical barriers, 16­17 Act Plant-made pharmaceuticals (PMPs), 24 NGOs. See Nongovernmental Plants organizations bioconfinement of, 65­129 methods of bioconfinement, 4

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252 INDEX Plastid engineering, 113 to consider potential effects of a Pleiotropy, 183 confinement failure on other PMPs. See Plant-made pharmaceuticals nations, 194 Pollen-specific gene expression, 95 to consider the need for Population effects, 126­129, 177­178 bioconfinement early in the Post-market Oversight of Biotech Foods, development of a GEO or its 35 products, 182 Potential effects of bioconfinement, current to define an adequate level of and future GEOs, 36­38 bioconfinement early in the Potential for gene flow, 118­120 development of a GEO, 184 Predation, heightened, 141 to develop better understanding of Private litigation invasion biology, 197­198 decision-making about to develop better understanding of the bioconfinement, 63­64 dispersal biology of organisms and the efficacy of confinement, 193 targeted for genetic engineering Production cycle for all-female lines of fish, and release, 197 in species with an XY sex to develop easily identifiable markers, determination system, 143 187­189 Production site characteristics, 144­145 to develop reliable, safe, and strengths and weaknesses, 145 environmentally sound Programmed cell death (PCD), 75 bioconfinement, 196 Proposed bioconfinement of transgenic to evaluate each GEO separately, 181 Atlantic salmon, 137­139 to identify economic, legal, ethical, Proposed transgenic bioconfinement and social factors influencing methods in plants, 73 application and regulation of Pseudomonas syringae, 22 particular techniques, 197 to incorporate transparency and public participation in R bioconfinement techniques and approaches, 189­190 RAC. See Recombinant DNA Advisory to pursue international cooperation to Committee adequately manage confinement RAFI. See Rural Advancement Foundation of GEOs, 194 International to support additional scientific Rationale for bioconfinement, 3­4 research, 196­198 rDNA. See Recombinant DNA organisms to take human error into account Recombinant DNA Advisory Committee when determining (RAC), 21­22 bioconfinement methods and Recombinant DNA (rDNA) organisms, 19­ evaluating their efficacy, 192 20 to test confinement techniques before Recommendations putting them into application, to assess bioconfinement techniques 183 with reference to temporal and to use an integrated confinement spatial scales of field release, 184 system approach for GEOs that to assess the efficacy of warrant confinement, 187 bioconfinement, 196­197 Recoverable block of function (RBF) to assess the environmental effects of technique, 112 confinement failure, 196 Reducing exposure to transgenic traits, 93­ to compare the novel genotype with 96 its progenitor before field flower- and fruit-specific gene release, 183­184 expression, 94­95

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INDEX 253 green-specific (chloroplast-targeting) S gene expression, 93 pollen-specific gene expression, 95 Safe bioconfinement, recommendation to roots and tuber-specific gene support additional scientific expression, 93­94 research to develop, 196 seed-specific gene expression, 95­96 Scale, changes of efficacy with, 184 vascular-tissue-specific gene Secondary phenotypic effects of expression, 94 transgenesis, 108­109 Reducing gene flow to crop relatives, 85­93 Seed saving, 26 chromosomal locations in Seed-specific gene expression, 95­96 allopolyploids, 88­90 strengths, 95 cross-incompatibility, 88 weaknesses, 95­96 fitness reduction in transgenic crop- Sexual reproduction wild progeny, 90­91 combining triploid sterilization with phenotypic and fitness handicaps, 91­ all-female lines, 142­144 93 disruption of, 132­145 repressible seed-lethal bioconfinement, production cycle for all-female lines of 86 fish in species with an XY sex repressible seed lethal confinement, determination system, 143 85­87 production site characteristics, 144­ Redundancy, 182­183 145 Reliable bioconfinement, recommendation sterilization through induction of to support additional scientific triploidy, 133­141 research to develop, 196 in wild relatives, 140­141 Repressible seed-lethal confinement, 85­87 Shellfish, bioconfinement of, 132­153 strengths, 87 SIT. See Sterile insect technique (SIT) weaknesses, 87 Social acceptability of bioconfinement "Repressor" molecules, 147 methods, 25­28 Resistance, delaying the evolution of, 52­53 case study of the technology Reversible transgenic sterility, 72­75 protection system-- strengths, 74 "terminator," 25­27 weaknesses, 74­75 consequentialism and public Risk assessment and management, 33 acceptance, 27­28 Risk assessment matrix, 32 Social factors influencing application and Risks, 30­35 regulation of particular associated with gene flow into natural techniques, 197 populations, 106­107 Spatial scales confinement failure with StarLink effectiveness of, 122­123 corn, 34 increases in and the efficacy of systematic risk assessment and confinement, 193 management, 33 "Split registrations," 34 Risks of most concern with trees, 106­110 Stability of transgenic confinement, 102­103 effects on nontarget organisms, 107­ StarLink: Impacts on the United States 108 Corn Market and World Trade, instability of transgene expression, 110 35 secondary phenotypic effects of StarLink corn, 23 transgenesis, 108­109 StarLinkTM Situation, The, 35 RNA silencing, 111­112 "Sterile feral" technology, 146 Rockefeller Foundation, 26 Sterile insect technique (SIT), 153­156 Rural Advancement Foundation strengths, 156 International (RAFI), 25, 28 weaknesses, 156

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254 INDEX Sterile triploids, 23, 70­71 excision of transgenes before strengths, 70 reproduction, 84 weaknesses, 71 nontransgenic scions on transgenic Sterility, 68­71, 110­111 rootstock, 83­84 interspecific hybrids, 69 Transgenes in chloroplast DNA, 79­81 unisexual plants lacking mates, 71 Transgenic algae, 121­122 Sterilization through induction of triploidy, Transgenic grasses, 115­121 133­141 genetically engineered turfgrasses, normal steps in gamete fertilization 115­120 and early cell division, 134 Transgenic male sterility, 77­78 proposed bioconfinement of strengths, 78 transgenic Atlantic salmon, 137­ weaknesses, 78 139 Transgenic mitigation (TM), 90 strengths, 133­135 Transgenic sterile insects, 156­157 use of tetraploids to maximize triploid strengths and weaknesses, 157 percentage, 136­141 Transgenic sterility, 71­76 weaknesses, 135­136 Transparency and public participation, 10, Strategic public investment, in 189­190 bioconfinement research, 195­ and the efficacy of confinement, 189­ 198 190 "Suicide genes," 23, 173­176 recommendation to incorporate bacteria, 173­174 transparency and public fungi, 174­175 participation in bioconfinement viruses, 175­176 techniques and approaches, 189­ Superfund cleanup sites, 173 190 Trees. See Genetically engineered trees Triploid sterilization, combining with all- T female lines, 142­144 Triploidization, combining with T-GURT. See Trait genetic use restriction interspecific hybrids, 152 technology strengths and weaknesses, 152 Taco Bell brand taco shells, 24 Triploidy, 111 "Tandem constructs," 90 Technology Protection System (TPS), 23 Temporal scale U effectiveness of, 124 increases in and the efficacy of Understanding Risk, 31 confinement, 193 Unisexual plants lacking mates, 71 "Terminator technology," 25­26 strengths, 71 Tetraploids, used to maximize triploid weaknesses, 71 percentage, 136­141 U.S. Department of Agriculture (USDA), 1­ Tissue-specific expression, 112­113 2, 23, 182 TM. See Transgenic mitigation Agricultural Research Service, 25 TPS. See Technology Protection System Animal and Plant Health Inspection Trait genetic use restriction technology (T- Service, 24, 36, 54, 56, 115 GURT), 72, 85 U.S. Environmental Protection Agency, 1, Transgene expression 24, 53, 62 artificially induced, 84­85 U.S. Fish and Wildlife Service, 62 instability of, 110 U.S. Food and Drug Administration (FDA), Transgene loss, 102­103 1, 61, 137­139 Transgenes absent from seeds and pollen, USDA. See U.S. Department of Agriculture 83­84

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INDEX 255 V horizontal genetic transfer into local populations, 166 V-GURT. See Variety genetic use invasion into indigenous populations, restriction technology 161 Variable functional sterility, 140 phenotypic handicapping, 169­170 Variety genetic use restriction technology suicide genes, 175­176 (V-GURT), 72­75, 84, 87 Vascular-tissue-specific gene expression, 94 Viruses W bioconfinement of, 169­179 displacement of indigenous Weediness, concerns about, 49­50 populations, 164 Wild hybrid, Festuca arundinacea and Lolium multiflorum Lam., 119

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