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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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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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION 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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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION 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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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION 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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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION 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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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION 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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