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From page 255...
... , 45, 47, 48, 63, 98, 121, 122 Asilomar Conference, 24 255 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
From page 256...
... , 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 INDEX 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, 149-171 (passim)
From page 257...
... effects, 135 toxicity, 8, 73, 165 transparency, 173-174 virus-resistant squash, 14,123-124,125 wild/weedy hybrids, 138, 139 257 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, 217218 genetic pest protection, 4647, 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, 12-18 (passim) , 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, 149-171 (passim)
From page 258...
... , 137, 143 viral coat proteins, 13, 14, 31, 133134, 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, 150151 toxicity testing, 8, 32, 73, 100, 110, 112113, 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, 4142, 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, 211213, 229-237 tobacco and tomatoes, 27
From page 259...
... , 96, 149, 220 wheat rust, 23, 48, 106-108 259 G Gain-of-transmission characters, 94-95 Gene expression, 7, 10, 16, 24, 51-54 (passim) , 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, 4042, 44-45, 54, 131 Health risks, 6, 7-8, 12, 35-36, 37, 136-137, 140, 148, 151, 165, 166, 180, 243244 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)
From page 260...
... , 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, 110111 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 INDEX Intraspecific hybrids, 58-59 Introduction of Recombinant DNA-Engineered Organisms into the Environment, 2, 5, 38, 40, 42-46, 54 Jurisdictional issues, 10-13,16, 27,134,144145, 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, 145146, 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
From page 261...
... 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, 4849, 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, 7879, 141 Public information, see Information dissemination Public opinion, 2,11, 34-35,155, 172, 224 R 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, 4246,54 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
From page 262...
... 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 S 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, 128-139 (passim)
From page 263...
... INDEX 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 T 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, 109110, 112, 239, 240 Bt, testing, 14, 63, 64-67, 69, 72,110,112113, 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, 4142, 45, 54, 56, 57, 59, 62-63, 136 secondary plant products, 41, 53-54, 5657, 70-71 testing, 7-8,13-14, 62-67, 72-73,102,140 EPA policy, 8, 32, 73, 100,110,112113, 114, 115, 116-120, 153, 165, 175, 212 Transcapsidation, 94-95 263 U UpJohn/Asgrow Seed Company, 31 V 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, 9395, 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 W 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, 165166 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 z Zeneca/Astra, 223, 227


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