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OCR for page 255
GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
Index
A
AgrEvo, 33, 222, 224, 225
Agrobacterium-transformation methods, 24-25, 45, 161
Allergenicity, 6, 7, 14, 34-36, 71-72, 136, 140, 169, 180
Bt, 109
conventional breeding techniques, 71-72
FDA policy, 14, 29, 166, 169, 176-177, 180
genetic variability, 42
pollen, 63
risk assessment, 42, 45, 54, 56, 57, 62-63
tests for, 7, 13-14, 62-67, 72-73, 102, 103
Animal and Plant Health Inspection Service (APHIS), 122, 124, 142, 146, 157, 161, 173-174, 177, 218, 230, 231
Animal feed and forage, 8, 74-75, 144, 169, 222, 239
Animal studies, 68-69, 72, 103, 116-120, 175, 232, 238-240
Antibiotics, 29(n.6), 45, 47, 48, 63, 98, 121, 122
Asilomar Conference, 24
B
Bacillus thuringiensis, 13-14, 27-28, 31-33
allergenicity, 109
case studies, 108-116
corn, 28, 33, 35, 36, 69, 76-77, 79, 108, 111-114, 142, 234-235, 238-239
cotton, 28, 33-34, 35, 37, 108, 114-116, 137, 166, 171, 232, 239-240
Department of Agriculture, 31-32, 110, 112, 115, 167-168
deregulated crops, dated list, 33
ecological risks, 110
EPA, 31-32, 35, 100, 110, 112-113, 114, 115, 116, 120, 166, 167-168, 171, 174, 238-240
field testing, 27-28, 63, 64
gene expression, 28, 118, 119, 234, 240
health risks, 51-52, 54, 63, 64-67, 69, 72, 116-120, 238-240
nontarget species, 36-37, 74, 75-77, 78, 79, 110-111, 112-113, 115, 116-120, 137, 142, 238-240
monarch butterflies, 36-37, 75-77, 113-114
peer review, 112-113
pest resistance to, 31-32, 35, 98, 100-101, 102, 103, 114-115
resistance management, 35, 167-168
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pollen, 37, 113-114, 142
potatoes, 31-32, 33, 35, 64, 65-66, 79, 108-111, 175, 240
risk assessment, general, 14, 51-52, 54, 63, 108-116
toxicity, general, 14, 27-28, 32, 63, 64-67, 109-110, 112, 239, 240
toxicity testing, 14, 63, 64-67, 69, 72, 110, 112-113, 115, 116-120, 175, 239, 240
see also Bt proteins
Bacteria, other, 25, 28, 96, 121, 149
Agrobacterium-transformation methods, 24-25, 45, 161
Bacterial resistance, 22, 34, 49, 50, 96, 220
Barley, 19, 22, 49, 82, 219, 235
Biffed, Roland, 23
Biodiversity,
see Ecological risks;
Nonmarket species Biotechnology Science Advisory Committee (EPA), 29
Bt
see Bacillus thuringienesis
Bt proteins, 7, 10, 13, 14, 32, 103, 108-109, 175
field testing, 27-28, 63, 64
resistance, 51-52, 102, 103
toxicity, 14, 64-65, 72, 75, 112, 113, 115, 116-120, 238, 239, 240
Brussels sprouts, 22
C
Calgene, 31, 33
Carcinogenicity, 14, 42, 48, 63
Celery, 71
Cell fusion, 21
Chemical pesticides, 1, 33-34, 37, 46-47, 111-112, 114-115
carcinogenicity, 63
economics of, 46, 109, 218-229
integrated pest management, use of, 20
natural plant chemicals, 47-48
nontarget species, 9, 78-79, 80
pest resistance to, 101, 102, 109
Ceiba-Geigy, 33, 222, 227
Confidential business information (CBI), 158, 173-174, 175, 177, 178, 181
Conventional breeding techniques, 3, 5, 7, 9, 12, 20, 22-23
allergenicity, 71-72
definitional issues, 5, 144
ecological impacts, 9
economic factors, 217-218
FDA review, 148-149
resistance traits, 44
risk assessment, 43, 45, 51, 62
toxicants in, 7-8
transgenic techniques combined with, 28, 51
transgenic techniques vs,4, 5-6, 21, 43, 45
wheat rust, 105-106
Coordinated Framework for the Regulation of Biotechnology, 2, 3, 10-18, 135, 144-181, 212, 244-245
approach, 11-12, 144-151
background, 10-11, 25-26, 144-145, 151, 172
costs, 17-18
Department of Agriculture, 15, 16, 26, 39, 144, 145-147, 155-171, 173-174, 180-181
EPA, 15, 16, 26, 39, 144, 145, (passim)149-171, 174-176, 177, 178-181
FDA, 15, 16, 26, 39, 144, 145, 147-149, 150, (passim)155-171 , 176-177, 180-181
historical perspectives, 10-11, 25-26, (passim)144-149
operational aspects, 15-17, 144-151
transparency, 15, 154, 156, 158, 172-178, 179, 180
Corn, 20, 22, 23, 49, 145, 157, 218, 219, 220, 226, 234, 235
Bt, 28, 33, 35, 36, 69, 76-77, 79, 108, 111-114, 142, 234-235, 238-240
pollen, 75, 76, 82
Cornell University, 33
Cost factors,
see Economic factors
Cotton, 75, 145, 217, 218, 219, 220, 226, 235
Bt, 28, 33-34, 35, 37, 108, 114-116, 137, 166, 171, 232, 239-240
gene-flow controls, 82
D
Databases, 8, 15-16, 135, 140, 141, 143, 167, 173, 177, 178, 181
Internet, 167, 173, 174, 176, 177, 181
Definitional issues, 15, 159-162
conventional pest-protected plant, 5, 144
exposure assessment, 41
food additive, 148
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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
genetically modified plant, 4-5, 144, 179
hazard identification, 41
naturally pest-protected plant, 5
nontarget species, 73-74
pest, 2, 149, 161-162
pesticide/pest-protected plant, 4, 127, 149, 150, 152, 159-160, 180, 212
pleiotropic (secondary) effect, 7
risk, 40
risk characterization, 41-42
toxicity, 73
transgenic pest-protected plant, 5, 144, 159-160
weed, 9
DeKalb Genetics, 33, 114, 222, 227, 228
Department of Agriculture, 3, 12, 15, 16, 17, 25, 28-29, 31, 142
Animal and Plant Health Inspection Service (APHIS), 122, 124, 142, 146, 157, 161, 173-174, 177, 218, 230, 231
Bt, 31-32, 110, 112, 115, 167-168
coordinated regulatory framework, 15, 16, 26, 39, 144, 145-147, 155-171, 173-174, 180-181
cost of testing, 212, 229, 230, 231
databases, 8, 15-16, 140, 141, 143, 173, 181
Federal Food, Drug, and Cosmetic Act, 157
Federal Insecticide, Fungicide, and Rodenticide Act, 164
Federal Plant Pest Act, 11, 26, 29, 145-146, 157, 164, 166, 167, 173, 181, 229
field testing, 28, 161
gene-flow controls, 82, 91, 165-166
interagency coordination, general, 15, 16, 135, 144
databases, 8, 15-16, 140, 141, 143, 178, 181
National Environmental Policy Act (NEPA), 147, 157, 164
permit/petition process, 28-29, 31, 146-147
Plant Quarantine Act, 157
secondary (pleiotropic) effects, 135
toxicity, 8, 73, 165
transparency, 173-174
virus-resistant squash, 14, 123-124, 125
wild/weedy hybrids, 138, 139
Department of Health and Human Services,
see Food and Drug Administration;
National Institutes of Health
Dose-response evaluation, 40-42, 54, 97-98
Dow Chemicals, 223, 227, 228
DuPont, 223
E
Ecological risks, 6, 9-10, 12, 37, 137-139, 140, 141-142, 151, 164, 165, 243
Bt, 110
economics of regulation, 17, 231
risk assessments, 41-42, 142, 168
secondary pests, 37
see also Gene-flow effects;
Nontarget species;
Resistant pests;
Weeds;
Wild plants
Economic factors, 213-229
chemical pesticides, 46, 109, 218-229
conventional breeding techniques, 217-218
genetic pest protection, 46-47, 109
pest impacts on crops, 19
R&D expenditures, 216-218
regulatory costs, 17-18, 38, 178-179, 181, 211-213, 229-237
resistant pests, 96
small and medium size businesses, 18, 38, 179, 181, 212, 213
wheat rust, 107-108
see also Funding
Education,
see Information dissemination
Eggs, 75, 114
Electroporation, 25
Empresas La Moderna, 223
Environmental Protection Agency, 3, 11, (passim)12-18 , 29-31, 102, 142
Bt, 31-32, 35, 100, 110, 112-113, 114, 115, 116, 120, 166, 167-168, 171, 174, 238-240
coordinated regulatory framework, 15, 16, 26, 39, 144, 145, (passim)149-171 174-176, 177, 178-181
cost of regulation, 212, 224, 229, 230-231, 233
exemptions, 153-154
sexual compatibility, 12-13, (passim)128-134 , 137, 143
viral coat proteins, 13, 14, 133-134, 143
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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
fact sheets, 16, 64, 65, 110, 116, 164, 174, 175, 181
Federal Food, Drug, and Cosmetic Act, 11, 30, 31, 32, 62, 128, 137, 151, 152, 153, 156, 157, 164, 174, 176, 212, 213, 232, 233
Federal Insecticide, Fungicide, and Rodenticide Act, 11, 13, 26, 30, 31, 32, 38, 62, 127, 128, 134, 137, 143, 149-154, 156, 157, 160, 162, 164, 168, 174, 176, 180, 211, 212, 213, 224, 229, 232, 233, 237
Federal Plant Pest Act, 157, 164
Food Quality Protection Act, 30-31, 127
gene expression, 12, 127, 130, 133, 165
health risks, 131-135, 151, 157, 162, 164, 165, 166, 167, 180
interagency coordination, general, 15, 16, 135, 137, 144, 162-168, 180
databases, 8, 15-16, 140, 141, 143, 178, 181
National Environmental Policy Act (NEPA), 25, 26, 147, 157, 164, 233
nonmarket species, 142, 165
plant-pesticide defined, 4
proposed rules (1994 and 1997), 4, 11, 12, 17, 30, 37-38, 39, 104, 126-139, 151-154, 156-157, 162-164, 174-176, 179-181
confidential business information, 175, 178, 181
nontoxic modes, 134
secondary (pleiotropic) effects, 37, 134-135, 143
sexual compatibility, 12-13, (passim) 128-134, 137, 143
viral coat proteins, 13, 14, 31, 133-134, 143, 160-161, 171
wild/weedy hybrids, 138-139
public opinion of, 37-38
resistant pests, 97-98, 100, 102
risk assessment, general, 37-38, 62-63, 128, 131-132
toxicity, general, 129-130, 132-133, 150-151
toxicity testing, 8, 32, 73, 100, 110, 112-113, 114, 115, 116-120, 153, 165, 175, 212
cost of testing, 212, 224, 229, 230-231, 233
transparency, 174-176, 179-180
viral coat proteins, 13, 14, 31, 133-134, 143, 160-161, 171
Exposure assessment, 41-42, 54, 131
F
Federal Environmental Pesticide Control Act, 20
Federal Food, Drug, and Cosmetic Act, 11, 13, 26, 29, 30-31, 32, 62, 128, 137, 151, 152, 153, 156, 157, 164, 174, 176, 211-212, 213, 232, 233
Federal government
interagency coordination, 15, 16, 18, 135, 144, 162-168
databases, 8, 15-16, 140, 141, 143, 178, 181
memoranda of understanding, 16, 163, 166, 180
see also Coordinated Framework for the Regulation of Biotechnology
jurisdictional issues, 10-13, 16, 27, 134, 144-145, 151, 154, 155, 157, 158, 162, 163, 180;
see also Department of Agriculture;
Environmental Protection Agency;
Food and Drug Administration;
Legislation;
National Institutes of Health;
Regulatory issues
Federal Insecticide, Fungicide, and Rodenticide Act, 11, 13, 26, 30, 31, 32, 38, 62, 127, 128, 134, 137, 143, 149-154, 156, 157, 160, 162, 164, 168, 174, 176, 180, 211, 212, 213, 224, 229, 232, 233, 237
Federal Plant Pest Act, 11, 26, 29, 145-146, 157, 164, 166, 167, 173, 181, 229, 232, 233, 237
Federal Register, 26, 31, 38, 130, 147, 166, 173, 174
Field testing, 5, 146, 220
Bt, 27-28, 63, 64
commercial, 42
Department of Agriculture, 28, 161
gene-flow effects studies, 88
regulatory, 1, 11, 20, 25, 27-28, 34, 46, 153, 161, 180
costs, 17-18, 38, 178-179, 181, 211-213, 229-237
tobacco and tomatoes, 27
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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
Field Testing Genetically Modified Organisms: Framework for Decisions, 46
Food additives, 29, 31, 148, 149, 157
Food and Drug Administration, 3, 12, 15, 16, 17, 29, 31, 71, 137
allergens, 14, 29, 166, 169, 176-177, 180
coordinated regulatory framework, 15, 16, 26, 39, 144, 145, 147-149, 150,(passim) 155-171 , 176-177, 180-181
conventional breeding techniques, 148-149
cost of regulation, 212, 213-214, 229-230, 231, 232-233
databases, funding, 177
databases, other, 8, 15-16, 140, 141, 143, 178, 181
ecological effects, 138
Federal Food, Drug, and Cosmetic Act, 11, 13, 26, 29, 30-31, 32, 62, 128, 137, 151, 152, 153, 156, 157, 164, 174, 176, 211-212, 213, 232, 233
food additives, 29, 31, 148, 149, 157
gene expression, 148, 149, 165
interagency coordination, general, 15, 16, 135, 137, 144, 162-168, 180
databases, 8, 15-16, 140, 141, 143, 178, 181
National Environmental Policy Act (NEPA), 233
secondary (pleiotropic) effects, 134-135
testing, 7-8, 62-63, 169, 212, 213-214, 229-230, 231
transparency, 177-178
toxicants, 7-8, 29, 62-63, 73
viral resistance, 121-122
Food Quality Protection Act, 20, 30-31, 127
Freedom of Information Act, 177
Funding
FDA database, 177
gene-flow effects studies, 88
NIH safety guidelines and, 24
report at hand, 2
Fungal pathogens, 19
flax rust, 48-49
wheat rust, 104-108
Fungal resistance, 23, 28, 34, (passim)46-51 , 96, 149, 220
wheat rust, 23, 48, 106-108
G
Gain-of-transmission characters, 94-95
Gene expression, 7, 10, 16, 24,(passim) 51-54 , 56, 63, 65, 140-141
Bt, 28, 118, 119, 234, 240
EPA policy, 12, 127, 130, 133, 165
FDA policy, 148, 149, 165
gene flow and, 81, 90
nonmarket species, 10
viral coat proteins, 95, 133
Gene-flow effects, 6, 9-10, 31, 36, 41, 43, 45, 80-93, 122-123, 124, 142, 165-166
cotton, 82
Department of Agriculture controls, 82, 91, 165-166
see also Sexual compatibility
Genomes
gene-flow effects, 90
size of common plants, table, 21, 22
viral resistance, 95
Guidance on Consultation Procedures for Foods Derived from New Plant Varieties, 169
H
Hazard identification, 40-42, 44-45, 54, 131
Health risks, 6, 7-8, 12, 35-36, 37, 136-137, 140, 148, 151, 165, 166, 180, 243-244
animal feed, 8, 74-75, 144, 169, 222, 239
animal studies, 68-69, 72, 103, 116-120, 175, 232, 238-240
Bt, 51-52, 54, 63, 64-67, 69, 72, 116-120, 238-240
carcinogenicity, 14, 42, 48, 63
economics of regulation, 17, 231, 232
EPA rulemaking, 131-135, 151, 157, 162, 164, 165, 166, 167, 180
risk assessments, 40-42, 45, 46, 54-73, 116-120, 121-122, 126, 131-137, 139-140
see also Allergenicity;
Food and Drug Administration;
Secondary (pleiotropic) effects;
Toxicity
Herbicides and herbicide tolerance, 4, 27, 33, 36, 39, 69, 81, 84, 87, 96, 123, 124, 145, 215, 218, 220, 224, 226, 228-229
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Herbivores, nontarget species, 50, 73-74, 75, 79, 89, 113
Historical perspectives, 1, 7, 19-20, 22-34, 38, 213-227
coordinated regulatory framework, 10-11, 25-26,(passim) 144-149
integrated pest management, 19-20
NAS research, 2, 5, 38, 40, 42-46, 54
regulatory framework, 25-32
transgenic crop varieties cleared, number, 32
wheat rust, 105, 106
Hormones, 56, 128, 134
Human health, see Health risks
I
Information dissemination, 3, 15-16, 81, 156, 172
confidential business information (CBI), 158, 173-174, 175, 177, 178, 181
EPA fact sheets, 16, 64, 65, 110, 116, 164, 174, 175, 181
Federal Register, 26, 31, 38, 130, 147, 166, 173, 174
interagency coordination, 15, 16, 18, 135, 144, 162-168
Internet, 167, 173, 174, 176, 177, 181
transparency, 15, 154, 156, 158, 172-178, 179-180
see also Databases
Insects and insect resistance, 28, 33, 34, 47, 49, 70, 149, 150, 220
chemical insecticides, 9, 34, 37, 41
induced resistance responses, 50, 96
nontarget species, 36, 74, 75, 77-79, 110-111
Monarch butterflies, 36-37, 75-77, 113-114
predators, 73-74, 77, 78-79, 141
pollenation, 80, 83
see also Bacillus thuringiensis
Integrated pest management, 19-20
Intergeneric hybrids, 59-60
International Conference on Recombinant DNA Molecules (Asilomar Conference) 24
International Food Biotechnology Council, 35
International Life Sciences Institute, 35
Internet, 167, 173, 174, 176, 177, 181
Intraspecific hybrids, 58-59
Introduction of Recombinant DNA-Engineered Organisms into the Environment, 2, 5, 38, 40, 42-46, 54
J
Jurisdictional issues, 10-13, 16, 27, 134, 144-145, 151, 154, 155, 157, 158, 162, 163, 180
interagency coordination, 15, 16, 18, 135, 144, 162-168
see also Coordinated Framework for the Regulation of Biotechnology
L
Labeling, 2, 147, 163, 167, 176-177, 180
Legislation
Federal Environmental Pesticide Control Act, 20
Federal Food, Drug, and Cosmetic Act, 11, 13, 26, 29, 30-31, 32, 62, 128, 137, 151, 152, 153, 156, 157, 164, 174, 176, 211-212, 213, 232, 233
Federal Insecticide, Fungicide, and Rodenticide Act, 11, 13, 26, 30, 31, 32, 38, 62, 127, 128, 134, 137, 143, 149-154, 156, 157, 160, 162, 164, 168, 174, 176, 180, 211, 212, 213, 224, 229, 232, 233, 237
Federal Plant Pest Act, 11, 26, 29, 145-146, 157, 164, 166, 167, 173, 181, 229
Food Quality Protection Act, 20, 30-31, 127
Freedom of Information Act, 177
National Environmental Policy Act, 25, 26, 147, 157, 164, 233
Plant Quarantine Act, 157
see also Regulatory issues
M
Maize,
see Corn
Memoranda of understanding, 16, 163, 166, 180
Mendel, Gregor, 22-23
Milk, 74
Monarch butterflies, 36-37, 75-77, 113-114
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Monsanto, 28, 32, 33, 110, 113, 115, 222, 223, 224, 225, 227, 228, 231-232, 234-235, 238-240
Mutagenesis, 21, 60-61
see also Somaclonal variation
N
National Environmental Policy Act (NEPA), 25, 26, 147, 157, 164, 233
National Institutes of Health, 24, 25
Nematodes, 19, 28, 34, 49, 53, 149, 220, 248
Nontarget species, 6, 9, 36-37, 89, 165, 231, 243-244
Bt, 36-37, 74, 75-77, 78, 79, 110-111, 112-113, 115, 116-120, 137, 142, 238-240
monarch butterflies, 36-37, 75-77, 113-114
chemical pesticides, 9, 78-79, 80
defined, 73-74
EPA, 142, 165
gene expression, 10
herbivores, 50, 73-74, 75, 79, 89, 113
insects, 36, 74, 75, 77-79, 110-111
Monarch butterflies, 36-37, 75-77, 113-114
predators, 73-74, 77, 78-79, 141
risk assessment, 41, 45, 73-80, 132, 137-138
see also Gene-flow effects;
Health risks
North American Free Trade Agreement, 167
Northurp King, 33
Novartis, 222, 227, 228
O
Oats, 22, 219, 235
Office of Science and Technology Policy, 25
P
Papaya, 22, 32, 33, 120, 121, 125-126, 145, 157
Particle-gun transformation, 25, 161
Pathogen resistance, 6, 9, 10, 14, 139, 141, 150
deregulated crops, dated list, 33
historical perspectives, 23
hypersensitive response, 50, 53
permits issues by category of resistance, 34
risk assessment, 44, 48-54, 93-95
R genes, 48-49, 50, 52-53, 55
see also Bacterial resistance;
Fungal resistance;
Resistance management;
Resistant pests;
Viral resistance
Peanuts, 22, 219
Peer review
Bt, 112-113
Plant Quarantine Act, 157
Pleiotropic effects,
see Secondary (pleiotropic) effects
Pioneer Hybrid International, 35-36, 227, 228
Pollen, 36, 75-77, 83, 141, 165
allergens, 63
Bt, 37, 113-114, 142
corn, 75, 76, 82
see also Gene-flow effects
Potatoes, 19, 22, 23, 32, 48-49, 52, 53, 68, 70, 74, 78-79, 145, 157, 217, 218, 219, 220
Bt, 31-32, 33, 35, 64, 65-66, 79, 108-111, 175, 240
Predators, nontarget species, 73-74, 77, 78-79, 141
Public information,
see Information dissemination
Public opinion, 2, 11, 34-35, 155, 172, 224
R genes, 48-49, 50, 52-53, 55
Race-specific R genes,
see R genes
Recombinant DNA (rDNA), general, 2, 5, 16, 144
allergenicity reduction, 36
Department of Agriculture permit process, 146
historical perspectives, 23-28
previous NAS research, 2, 5, 38, 40, 42-46, 54
role of committee report, 38
Red Book,41
Regulatory issues, general, 1, 10-11, 15-18, 25-27, 37-38, 104, 241-242
committee charge, 2-3
confidential business information, 158, 173-174, 175, 177, 178, 181
costs, 17-18, 38, 178-179, 181, 211-213, 229-237
databases, 8, 15-16, 135, 140, 141, 143, 167, 173, 178, 181
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Internet, 167, 173, 174, 176, 177, 181
ecological impacts, 10, 17, 231
economics of, 17-18, 38, 178-179, 181, 211-213, 229-237
gene-flow controls, 82, 91, 165-166
jurisdictional issues, 10-13, 16, 27, 134, 144-145, 151, 154, 155, 157, 158, 162, 163, 180
labeling, 2, 147, 163, 167, 176-177, 180
public opinion, 2, 11, 34-35, 155, 172, 224
state-level, 173-174
transparency, 15, 154, 156, 158, 172-178, 179-180
voluntary standards, 18, 168, 180, 229-230
see also Coordinated Framework for the Regulation of Biotechnology;
Definitional issues;
Department of Agriculture;
Environmental Protection Agency;
Food and Drug Administration;
Information dissemination;
Legislation;
National Institutes of Health
Regulatory testing, 7, 8, 10, 16, 62-68
allergenicity/toxicity testing, 7-8, 13-14, 62-68, 102, 103, 130, 140
Bt, 14, 27-28, 63, 64-67, 69, 72, 110, 112-113, 115, 116-120, 175, 239, 240
toxicity, 14, 63, 64-67, 69, 72, 110, 112-113, 115, 116-120, 175, 239, 240
costs, 17-18, 38, 178-179, 181, 211-213, 229-237
field testing, 1, 11, 20, 25, 27-28, 34, 46, 153, 161, 180
costs, 17-18, 38, 178-179, 181, 211-213, 229-237
EPA, 8, 32, 73, 100, 110, 112-113, 114, 115, 116-120, 153, 165, 175, 212
cost of testing, 212, 224, 229, 230-231, 233
FDA, 7-8, 62-63, 169, 212, 213-214, 229-230, 231
gene-flow effects, 91
Resistance management, 10, 45, 46-47, 97-101, 103, 141, 167
Bt, 35, 167-168
Coordinated Framework, 11
Resistant pests, 6, 9, 10, 34, 35, 95-102, 167
Bt, 31-32, 35, 98, 100-101, 102, 103, 114-115
chemical pesticides, 101, 102, 109
EPA, 97-98, 100, 102
Rhone-Poulenc, 222
Rice, 22, 23, 36, 82, 219, 220, 235
Risk assessment, 40-45, 54-103, 139-140, 168, 180
allergenicity, 42, 45, 54, 56, 57, 62-63
Bt, 14, 51-52, 54, 63, 108-116
conventional breeding techniques, 43, 45, 51, 62
dose-response evaluation, 40-42, 54, 97-98
ecological risks, 41-42, 142, 168
nonmarket species, 41, 45, 73-80, 132, 137-138
EPA, 37-38, 62-63, 128, 131-132
secondary (pleiotropic) effects, 37, 134-135, 143
exposure assessment, 41-42, 54, 131
hazard identification, 40-42, 44-45, 54, 131
health risks, 40-42, 45, 46, 54-73, 116-120, 121-122, 126, 131-137, 139-140
nontarget species, 7-8, 13-14, 62-68, 102, 103, 130
pathogen resistance, 44, 48-54, 93-95
risk characterization, 24, 37, 41-42
secondary (pleiotropic) effects, 7, 37, 58, 62, 63, 69-72, 134-135, 143
EPA, 37, 134-135, 143
toxicity, 41-42, 45, 54, 56, 57, 59, 62-63, 136
see also Ecological risks, Health risks;
Regulatory testing
Rye, 60, 82
Secondary (pleiotropic) effects, 7, 37, 58, 62, 63, 69-72, 134-135, 143
EPA, 37, 134-135, 143
Secondary plant products, 41, 53-54, 56-57, 70-72
Sexual compatibility, 20-21, 24, 30, 45, 51, 58, 61, 88, 106, 107, 123,(passim) 128-139
EPA exemption, 12-13, (passim)128-134 , 137, 143
Small and medium size businesses, 18, 38, 179, 181, 212, 213
Social factors, 2
Somaclonal variation, 21, 61
Somatic-cell fusion, 61, 70-71
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Soybeans, 22, 35, 69, 82, 145, 217, 218, 219, 220, 226, 235
Squash, 14, 31, 32, 33, 120-125, 145, 157, 171
State-level regulation, 173-174
Tobacco, 53, 74, 77, 116, 220, 235
gene-flow controls, 82
genome size, 22
regulatory field testing, 27
Tomatoes, 31, 33, 49, 74, 220, 235
gene-flow controls, 82
genome size, 22
regulatory field testing, 27
Toxicity, 6, 7-8, 13-14, 34-35, 140
Bt, general, 14, 27-28, 32, 63, 64-67, 109-110, 112, 239, 240
Bt, testing, 14, 63, 64-67, 69, 72, 110, 112-113, 115, 116-120, 175, 239, 240
definitional issues, 73
Department of Agriculture policy, 8, 73, 165
EPA policy, general, 129-130, 132-133, 150-151
EPA testing policy, 8, 32, 73, 100, 110, 112-113, 114, 115, 116-120, 153, 165, 175, 212
cost of testing, 212, 224, 229, 230-231, 233
FDA policy, 7-8, 29, 62-63, 73
naturally occurring plant chemicals, 48
risk assessment, 41-42, 45, 54, 56, 57, 59, 62-63, 136
secondary plant products, 41, 53-54, 56-57, 70-71
testing, 7-8, 13-14, 62-67, 72-73, 102, 140
EPA policy, 8, 32, 73, 100, 110, 112-113, 114, 115, 116-120, 153, 165, 175, 212
Transcapsidation, 94-95
UpJohn/Asgrow Seed Company, 31
Viral coat proteins, 30, 31, 32, 52, 57, 63, 95, 171
EPA exemption, 13, 14, 31, 133-134, 143, 160-161, 171
Viral resistance, 28, 32, 33, 35, 50-51, 52, 93-95, 120-126, 150, 220
mosaic viruses, 27, 31, 32, 53, 121, 124, 161
R gene, 49
squash, 14, 31, 33, 120-125
transcapsidation, 94-95
Voluntary standards, 18, 168, 180, 229-230
Weeds, 45, 122-124, 138-139, 141-142, 149
gene-flow effects, 6, 9-10, 31, 36, 41, 43, 45, 80-93, 122-123, 124, 142, 165-166
resistance to control, 96, 142
viral coat proteins, 13
Wheat, 19, 22, 23, 60, 82, 217, 218, 219, 220, 235
rust, 23, 48, 104-108
Wild plants, 20-21, 35, 74, 138-139, 142
gene-flow effects, 83-90, 92, 142
squash, 31, 122-125
wheat, 22
see also Gene-flow effects;
Weeds
World Wide Web,
see Internet
Zeneca/Astrat, 223, 227
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Representative terms from entire chapter:
health risks
