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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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