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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation (2002)
Board on Agriculture and Natural Resources (BANR)

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309
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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation

Index

A

Acid deposition, 24, 223

Agricultural Biotechnology Research Advisory Committee (ABRAC), 10, 104, 171-172

Agricultural Extension Service, 17, 105, 135, 144

trained observer monitoring, 206, 207

Alien species, see Invasive species

Animal and Plant Health Inspection Service (APHIS), 1, 7-14, 15, 50-51, 101-191, 230, 234, 236, 251, 253-254

Biotechnology, Biologics, and Environmental Protection unit (BBEP), 1, 8, 12, 50, 60, 101, 187, 190

case studies, 121-166, 177-178, 187, 189

committee mission, 1-2, 19, 20, 21, 296

committee recommendations, 8-16(passim), 106, 174-178 (passim), 182, 186, 187, 191, 197, 198, 208, 211, 212, 218

confidential business information (CBI), 11-12, 177

conventionally improved plants, 4, 20, 78, 80, 82, 251

Coordinated Framework for the Regulation of Biotechnology, 1, 19, 20, 49-50, 101, 171, 246, 289

definitions, regulatory, 102, 103, 106-107

developing countries, 176

DNA, 108-109, 114-116, 119, 137-139, 141, 143, 146, 185-186;

see also “genomics” infra

environmental assessments, 2, 8, 9-11, 20, 126, 160-165, 252, 296-297

expert judgment, 60, 168, 174-175, 187-188

field testing, 1, 9, 12, 21, 60, 63, 105, 170, 175

notification process, 108, 109-110, 122-123

permitting process, 111, 113, 117, 123-126

petitions for deregulation, 126, 140, 147, 154, 183, 189

time factors, 9, 51, 108, 169, 173, 174

Food and Drug Administration and, 108, 141

genomics, 11, 108, 116, 143, 185, 186;

see also “DNA” supra

hazard identification, 54-55, 59, 65-77, 169, 172, 218, 243, 255

herbicides, notification and deregulation, 123, 129, 165

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Index A Acid deposition, 24, 223 Agricultural Biotechnology Research Advisory Committee (ABRAC), 10, 104, 171-172 Agricultural Extension Service, 17, 105, 135, 144 trained observer monitoring, 206, 207 Alien species, see Invasive species Animal and Plant Health Inspection Service (APHIS), 1, 7-14, 15, 50-51, 101-191, 230, 234, 236, 251, 253-254 Biotechnology, Biologics, and Environmental Protection unit (BBEP), 1, 8, 12, 50, 60, 101, 187, 190 case studies, 121-166, 177-178, 187, 189 committee mission, 1-2, 19, 20, 21, 296 committee recommendations, 8-16(passim), 106, 174-178 (passim), 182, 186, 187, 191, 197, 198, 208, 211, 212, 218 confidential business information (CBI), 11-12, 177 conventionally improved plants, 4, 20, 78, 80, 82, 251 Coordinated Framework for the Regulation of Biotechnology, 1, 19, 20, 49-50, 101, 171, 246, 289 definitions, regulatory, 102, 103, 106-107 developing countries, 176 DNA, 108-109, 114-116, 119, 137-139, 141, 143, 146, 185-186; see also “genomics” infra environmental assessments, 2, 8, 9-11, 20, 126, 160-165, 252, 296-297 expert judgment, 60, 168, 174-175, 187-188 field testing, 1, 9, 12, 21, 60, 63, 105, 170, 175 notification process, 108, 109-110, 122-123 permitting process, 111, 113, 117, 123-126 petitions for deregulation, 126, 140, 147, 154, 183, 189 time factors, 9, 51, 108, 169, 173, 174 Food and Drug Administration and, 108, 141 genomics, 11, 108, 116, 143, 185, 186; see also “DNA” supra hazard identification, 54-55, 59, 65-77, 169, 172, 218, 243, 255 herbicides, notification and deregulation, 123, 129, 165

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation historical perspectives, 8, 19, 72-74, 83, 101, 120, 167, 173, 174, 190 legislative mandates, Federal Noxious Weed Act, 108 Federal Plant Pest Act, 1, 4, 49, 50, 81-87, 101-102, 234, 253-254 Federal Plant Quarantine Act, 1, 4, 49, 50, 87, 101-102, 234, 253-254 Plant Protection Act (proposed), 15- 16, 101, 236, 253-254 monarch butterfly protection, Bt, 72-74 non-target species, 177-178, 179, 180-182, 296 petitions for deregulation status, 129-130, 140-141, 154-156, 157, 161, 163, 188, 189 notification requirements, 2, 9, 10, 13, 51, 87, 104, 105, 107-110, 112, 121-123, 167-181 (passim), 190, 296 field testing, 108, 109-110, 122-123 pharmaceuticals, 9, 108, 180 pollen, 132-133, 181 standards, 109, 122 time factors, 9, 51, 108, 169, 173, 174 permitting, 9-10, 13, 110-111, 112, 123-126, 168, 169, 170, 172, 173, 175, 178, 179, 183, 190 field testing, 131, 132, 133-135, 150-151, 183-184 pharmaceuticals, 9-10, 110, 123-126 pollen, 124-125, 188 spatial factors, 124-125, 131, 179, 188-189 time factors, 11, 132 petitions for nonregulation status, 8, 9, 10, 13, 50, 73, 102, 104, 111-118, 168, 169, 170, 175-176, 183-190, 233, 235, 252, 296 case studies, 126-166, 167 extension of determination of, 104, 118-120 field testing, 131, 132, 133-135, 150-151, 183-184 hybridization, 131, 132, 133-135, 150-151, 183-184 non-target species, 129-130, 140-141, 154-156, 157, 161, 163, 188, 189 pharmaceuticals, notification process, 9, 108, 180 permitting, 9-10, 110, 123-126 postcommercialization testing and monitoring, 12-14, 192-219 theoretical issues, 193-196 public input, 9-10, 12, 104, 105, 118, 127, 135, 165-166, 168-175, 182, 188, 191, 212 reference scenarios, 90, 91, 122-123 risk analysis, general, 6, 60, 81-87, 172, 252-254 spatial factors, 8-9, 13, 103-104, 150, 176, 179, 184, 191 permitting process, 124-125, 131, 179, 188-189 staffing, 12, 182, 187, 191, 205-207 standards, 109, 122, 187 time factors, notification and field testing, 9, 51, 108, 169, 173, 174 permitting, 111, 132 regulation, other, 102, 118-120, 135, 169 viruses, 104, 106, 109, 113-114, 116-117, 118, 126-135, 152, 159-160, 187 weediness, 11, 104, 105, 113, 122, 130-133, 139-140, 142, 147-150, 160, 165, 178-179 weeds, general, 104, 105, 113, 122, 156-157 wild relatives, 129-135 (passim), 149-153, 157, 160, 163 Animal feed, 136, 181, 307 Antibiotic resistance, 44, 89, 119, 125, 145-146 Antibiotics, other, 144, 145, 228 Avidin, 9, 180-181 B Bacillus thuringiensis (Bt), 7, 38, 39, 70-75, 184, 196, 233-234, 301 corn, 7, 8, 38-39, 70-75, 125, 144-158, 167, 179, 188, 221, 234-235 EPA role, 73-74, 157, 235 monarch butterflies, effects on, 71-75, 197, 216 reference scenarios, 87, 91-92, 93-94, 96-98 cotton, 9, 131, 158-166, 184, 221, 234 EPA role, 9, 159, 160-161, 165, 184 EPA, general, 233-234

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation genomics, 145, 159 international perspectives, 163-164 pollen, 7, 96, 150, 156, 165 poplars, 69, 92, 145, 184, 222-223 reference scenarios, 87, 89, 91-92, 93-94, 96-98 rice, 70, 71 Backcrossing, 41-42, 43, 47, 98 Bermudagrass, 121-123 Biodiversity, general, 18, 210 see also Endangered and threatened species; Invasive species; Landscape effects Convention on Biodiversity, 65, 248 edge effects, 22, 27 hazard identification, 76 National Resources Inventory, 200 outflows from agroecosystems, 24, 25, 26 trophic cascade, 25 Biological indicators, see Ecological indicators Biosafety Protocol of the Convention on Biodiversity, 65, 248, 249 Biotechnology, Biologics, and Environmental Protection unit (BBEP), 1, 8, 12, 50, 60, 101, 187, 190 Biotechnology Risk Assessment and Risk Management Program, 13, 198 Biotechnology Risk Assessment Research Grant Program (BRARGP), 197, 255 Birds, 22, 201, 202 invasive species, 207 outflows from agroecosystems, 24, 26 Bt, see Bacillus thuringiensis C Canada, 26, 56-57 Canola, 79-80, 86, 165 Cartagena Protocol on Biosafety, 248, 249 Case studies, 121-166, 178 APHIS, 121-166, 177-178, 187, 189 EPA, 157, 159, 160-161, 165 Office of Science and Technology Policy, 178 Chemicals, 7, 144-145 see also Fertilizer; Herbicides; Pesticides mutagenesis induced by, 42 Climate, 24, 30, 34-35, 142, 203, 222, 223, 230, 231 see also Precipitation; Weather bermudagrass, 120-123 drought, 37, 64, 121-123, 230, 231-232, 233-234 Coastal zones, nitrogen deposition, 24, 25-26 Comparative risk approach, see Reference scenarios/comparative risk approach Confidential business information (CBI) APHIS oversight, 11-12, 177 Office of Science and Technology Policy, 178 Conservation issues, see Biodiversity; Ecological indicators; Endangered and threatened species; Landscape effects Conservation Reserve Program, 200 Convention on Biodiversity, 65, 248, 249 Conventional crops, general, 142, 256 insect resistance, 144 reference scenarios, 87-88, 91-92 virus-resistant squash, 127 Conventionally improved crops, 32, 37-43, 48, 49, 77, 78 APHIS regulation, 4, 20, 78, 80, 82, 251 insect resistance, 37, 38, 39, 41, 43, 144-145, 153 mutagenesis, 37, 40-43 regulatory issues, general, 5, 20, 29, 62, 63, 79, 82, 83-86, 142, 143 Coordinated Framework for the Regulation of Biotechnology, 1, 19, 20, 49-50, 101, 171, 246, 289 Corn, 30, 31, 33, 38-39, 123-126, 179, 224- 225, 301, 303 avidin, 9, 180-181 Bt, 7, 8, 38-39, 70-75, 125, 144-158, 188, 234-235 monarch butterflies, effects on, 71-75, 197, 216 reference scenarios, 87, 91-92, 93-94, 96-98 hybridization, 41-42, 149-153, 157 whole-plant hazards, 68-69 Cost and cost-benefit factors see also Funding chronic illness, 239 crop damage, 222

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation ecological indicator monitoring, 209, 210 fault-tree analysis, 96 monoclonal antibody production, 228 postcommercial monitoring, 206, 209, 210, 257 trained-observer monitoring, 206 Cotton, 9, 131, 158-166, 184, 221, 234 Court cases, see Litigation Cry toxin, 38-39, 73, 88-89, 91, 96-98, 146, 154, 159, 161, 162 see also Bacillus thuringiensis Cytoplasmic male-sterile genotypes, 30, 33 D Department of Agriculture, 235, 243, 245 see also Agricultural Extension Service; Animal and Plant Health Inspection Service; Coordinated Framework for the Regulation of Biotechnology Agricultural Biotechnology Research Advisory Committee, 10, 104, 171 Biotechnology Risk Assessment and Risk Management Program, 13 Biotechnology Risk Assessment Research Grants Program, 197, 255 Initiative for Future Agriculture and Food Systems program, 197-198, 255 committee mission, 1-2, 19, 296 committee workshop agenda, 290 National Agricultural Statistics Service, 199, 200-201, 218 National Biological Impact Assessment Program, 170 National Resources Inventory, 14, 199- 201, 210, 218 Natural Resources Conservation Service, 199, 213 social effects research, 259 Department of Health and Human Services, see Food and Drug Administration Developing countries, 237-238, 239 extra-territorial regulation, 16, 176 Green Revolution, 4-5, 16, 34-35, 250-252 malnutrition, 226-227 reference scenarios, 87-88 Disease resistance, 41, 76, 115, 152, 186-187, 201, 220, 244 T-DNA, 44 vaccines, 228 viruses, 104, 113, 116-117, 118, 126-135, 152, 159-160 DNA, 28, 40-48, 54, 230, 238, 248, 250, 251, 253 see also Genomic factors; Mutagenesis APHIS regulatory process, 108-109, 114-116, 119, 137-139, 141, 143, 146, 185-186 open reading frames, 185 postcommercialization monitoring, 185, 214, 215 reference scenarios, 89 Southern analysis, 114, 115-116 T-DNA, 43-45, 47 transcription, 40-41, 45, 46 transposons, 40-41 viral resistance, 127-128 Drought, 37, 64, 121-123, 230, 231-232, 233-234 Drugs, see Pharmaceuticals E Ecological indicators, 14, 22-27, 49, 194 see also Biodiversity; Landscape effects; Nonindigenous species; Non-target species; Weediness; Wild relatives Bt toxins, 162 long-term monitoring, 206, 208-213, 217-218 trained-observer monitoring, 206, 217-218, 257 Economic factors, 16, 33, 49, 236, 237, 238, 241, 245, 259 see also Confidential business information; Cost and cost-benefit factors; Funding; Intellectual property; Yield factors Education and training postcommercialization testing and monitoring, 13, 205-207, 217-218, 219, 257

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation public education, 242-245; see also Public input; Public opinion staff of APHIS, 12, 182, 187, 191, 205-207 Endangered and threatened species, 31, 156, 199, 201, 216, 255; see also Biodiversity hazard identification, 71-76 Environmental Protection Agency, 10, 11, 19, 177-178, 179-180 see also Coordinated Framework for the Regulation of Biotechnology Bt corn, 73-74, 157, 235 Bt cotton, 9, 159, 160-161, 165, 184 Bt crops, general, 233-234 case studies, 157, 159, 160-161, 165 expert judgments, 60 reference scenarios, 91 resistance evolution, 76, 91 Enzymes, 37-38, 47, 136, 221, 236 ELISA, 116 Southern analysis, 114, 115-116 T-DNA, 43-44, 47 Epidemiology, 59, 61, 132 standards, 6, 217 Europe, 18 habitat loss, 22 outflows from agroecosystems, 25 sugar beet, 33 European Union, risk analysis, 65, 66, 247-248 Event-tree analysis, 90, 96-98 Exotics, see Invasive species Experimental methods, 35, 59-60, 61, 113 see also Case studies; Field testing reference scenarios, 88, 98-99 standards, 6 Expertise, 6-7, 60, 61, 174-175, 213 APHIS, 60, 168, 174-175, 187-188 committee members and other study contributors, 291-294, 298-304 peer review, 10, 168, 188, 198 F Fault-tree analysis, 12, 88, 89, 93-96, 190-191 Federal Administrative Procedures Act, 168-169, 171 Federal Geographic Data Committee, 213 Federal Noxious Weed Act, 108 Federal Plant Pest Act, 1, 4, 49, 50, 81-87, 101-102, 234, 253-254 Federal Plant Quarantine Act, 1, 4, 49, 50, 87, 101-102, 234, 253-254 Federal Register, 9, 10, 12, 103, 104, 106, 112, 118, 127, 130, 135, 165-166, 169, 170, 171, 173, 174, 183 Fertilizer, 22, 37 Green Revolution, 34-35, 250-251 nitrogen, 22, 24, 25-26 outflows from agroecosystems, 24-25 phosphorus, 22-22 reference scenarios, 88 rice, 4-5 Field testing, 1, 9, 12, 21, 60, 63, 105, 170, 175, 193, 194, 195, 235, 302 see also Postcommercialization testing and monitoring APHIS notification process, 108, 109-110, 122-123 APHIS permitting process, 111, 113, 117, 123-126 APHIS petitions for deregulation, 126, 140, 147, 154, 183, 189 virus resistance, 126 Fish and fish habitat, 23, 26, 201, 202 Fish and Wildlife Service, 202 Flowers, 31, 44, 66-67, 258 Food and Drug Administration see also Coordinated Framework for the Regulation of Biotechnology APHIS deregulation petitions, 141 APHIS notification process, 108 non-target species, 180 pharmaceutical products, 246-247 Foreign countries, see Developing countries; International perspectives Forest ecosystems, 24, 26, 223-224, 302 alien species, 26-27 poplars, Bt, 69, 92, 145, 184, 222-223 Funding, 15, 16, 245, 255-256 Biotechnology Risk Assessment Research Grants Program, 197, 255 Initiative for Future Agriculture and Food Systems program, 197-198, 255 National Resources Inventory, 14 postcommercialization testing and monitoring, 13, 14, 197-198, 202

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation private, 15 social effects research, 259 wildlife conservation, 202 Fungi, 43, 45, 66, 76, 103, 106, 234, 302 G Genomic factors, 4, 5, 30-31, 36, 39-41, 43, 46, 78 see also DNA APHIS regulatory assessments, 11, 108, 116, 143, 185, 186 Bt, 145, 159 reference scenarios, 98 viral resistance, 128 Geographic factors, see Spatial factors Grassland ecosystems, 24, 27 Green Revolution, 4-5, 16, 34-35, 250-252 Gulf of Mexico, 25-26 H Hazard identification, 54-55, 59, 61, 63, 65-77, 169, 172, 218, 243, 255 Health issues, humans, 17-18, 180-182, 215, 226-229, 239, 244 see also Pharmaceuticals committee workshop agenda, 290 hazard identification, 65-66, 68 malnutrition, 226-227, 238-240 minerals, dietary, 224, 226-227 vaccines, 228, 229 vitamins, 226, 227, 229 Herbicide resistance, 14-15, 38, 39, 44, 68, 70-71, 76, 84, 86, 90, 100, 131, 148, 149-151, 153, 158-159, 184, 220, 233, 234, 237, 244-245 see also Weediness Herbicides, other APHIS deregulation permits, 129 APHIS notification process, 123, 165 EPA regulation, 9, 159 Historical perspectives, 3, 4-5, 17-19, 21, 29-36, 77, 198-199, 203, 215, 220, 239, 250 alien species, 26, 29-36 APHIS, 8, 19, 72-74, 83, 101, 120, 167, 173, 174, 190 conventional crop improvement, 37, 62 Green Revolution, 4-5, 16, 34-35, 250-252 incentive programs, 3, 17 integrated pest management, 164 risk analysis, 2-3, 29-33, 36, 53, 71-76, 83 Horizontal gene transfer, 43, 48, 66-67 Horticulture, 28, 29, 31 Hybridization, 5, 29, 31-32, 42-43, 48, 115-116 see also Weediness; Wild relatives APHIS deregulation petitions, 131, 132, 133-135, 150-151, 183-184 backcrossing, 41-42, 43, 47, 98 corn, 40-42, 149-153, 157 wild relatives, 67-68 Hypoxia, 25, 26 I Incentive programs, 235, 237 historical perspectives, 3, 17 Indicator monitoring, see Ecological indicators; Postcommercialization testing and monitoring Industrial feedstocks, 235-236, 241-242, 246 Initiative for Future Agriculture and Food Systems program, 197-198 Insects, 22, 31, 32, 34, 102-103 see also Pesticides integrated pest management, 157, 164-165, 234 natural enemies, 28, 35, 70, 73, 75, 133, 144, 155-156, 255, 301 non-target species, 71-76, 154-156, 157, 163, 197, 216, 244, 255 pollen dispersal, 67, 156, 158, 214, 244, 255 resistance by, 7, 65, 76-77, 196, 301; see also Resistance evolution resistance to, by conventionally improved crops, 37, 38, 39, 41, 43, 129, 144-145, 153, 201, 220, 244; see also Bacillus thuringiensis Integrated pest management, 157, 164-165, 234 Intellectual property, 215 see also Confidential business information International perspectives, 3-4, 18, 239-242 see also Developing countries; Europe; European Union alien species, 31-32, 69 Bt cotton, 163-164

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Convention on Biodiversity, 65, 248, 249 ecological indicator standards, 210 extra-territorial regulation, 16, 176, 247-250 outflows from agroecosystems, 24, 25, 26 risk analysis, 56-57, 117 European Union, 65, 66, 247-248 precautionary principle, 64-65, 66, 247-250 WTO/WHO, 56-57 Internet, 129, 145-146, 162, 170, 225, 297 Invasive species, 4, 23, 24, 26-27, 30-33, 36, 81-82, 178-179, 203, 256, 302 forest ecosystems, 26-27 historical perspectives, 26, 29-36 international perspectives, 31-32, 69 postcommercialization testing and monitoring, 195, 203, 205, 207, 216 purposeful introduction, 28-29 whole-plant hazard identification, 69-70 Irrigation, 30, 37, 239 drought, 37, 64, 121-123, 230, 231-232, 233-234 L Landscape effects, 2, 22, 24, 27-28, 244 committee mission, 20 edge effects, 22, 27 horticultural, 28 National Resources Inventory, 200 Legislation, 49, 245, 253 see also Regulatory issues Biosafety Protocol of the Convention on Biodiversity, 65, 248, 249 European Union, 65, 66, 247-249 Federal Administrative Procedures Act, 168-169, 171 Federal Noxious Weed Act, 108 Federal Plant Pest Act, 1, 4, 49, 50, 81-87, 101-102, 234, 253-254 Federal Plant Quarantine Act, 1, 4, 49, 50, 87, 101-102, 234, 253-254 Migratory Bird Treaty Act, 198-199 National Environmental Protection Act, 183 Plant Protection Act (proposed), 15-16, 101, 236, 253-254 risk analysis, general, 58, 65, 80-81 Rural Development Act, 199 Smith-Lever Act, 17 Soil and Water Resources Conservation Act, 199 Litigation, 237 risk analysis, 58, 74 M Maize, see Corn Mammals, 22, 201 edge effects, 27 as plant pests, 107 Methodological issues, see Epidemiology; Experimental methods; Models and modeling; Research methodology; Risk analysis Mexico, 32, 33, 163-164 Migratory Bird Treaty Act, 198-199 Minerals, dietary, 224, 226-227 Minicommunities, 29-36 Models and modeling see also Theoretical perspectives exposure pathways, 53, 66, 98 resistance evolution, 196 risk analysis, 52-53, 59, 61, 93-99 event-tree analysis, 90, 96-98 fault-tree analysis, 12, 88, 89, 93-96, 190-191 standards for, 6-7, 53-56, 58-62, 255 two-part model, 90-91, 98 whole organism, 91-92 Monarch butterflies, Bt effects on, 71-75, 197, 216 Monitoring and validation processes, 2, 168, 182 see also Postcommercialization testing and monitoring Multiple transgenes, 15 Mutagenesis, 5, 47, 185 backcrossing, 41-42, 43, 47, 98 conventionally improved crops, 37, 40-43 radiation-induced, 42 soybean, 137, 142 N National Agricultural Statistics Service, 199, 200-201, 218 National Biological Impact Assessment Program, 170

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation National Environmental Protection Act, 183 National Marine Fisheries Service, 202 National Resources Inventory, 14, 199-201, 210, 218 National Spatial Data Infrastructure, 213 Natural enemies of insects, 28, 35, 70, 73, 75, 133, 144, 155-156, 255, 301 Natural Resources Conservation Service, 199, 213 Netherlands, 24 Nitrogen, 22, 24, 25-26, 34 Nonindigenous species, see Invasive species Non-target species, 2, 3, 7, 35, 36, 117, 125, 162, 180-181, 255 see also Wild relatives APHIS deregulation petitions, 129-130, 140-141, 154-156, 157, 161, 163, 188, 189 APHIS regulation, other, 177-178, 179, 180-182, 296 endangered and threatened species event-tree analysis, 96 hazard identification, 65, 70-76 insects, 71-76, 154-156, 157, 163, 197, 216, 244, 255 postcommercialization testing and monitoring, 196, 197, 214, 216 Northern analysis, 116 Notification requirements, 2, 9, 10, 13, 51, 87, 104, 105, 107-110, 112, 121-123, 167-181 (passim), 190, 296 O Office of Science and Technology Policy, 50, 80-81, 178 Outcrossing, 33, 125, 140 P Pathogen resistance, see Disease resistance Pedigree breeding, 40 Peer review, 10, 168, 188, 198 Pesticides, 7, 22, 28, 35, 36, 144-145, 180 avidin, 9, 180-181 Cry toxin, 38-39, 73, 88-89; see also Bacillus thuringiensis natural enemies, 28, 35, 70, 73, 75, 133, 144, 155-156, 255 reference scenarios, 88-89 resistance to, 7, 65, 76-77, 196, 301; see also Resistance evolution Pharmaceuticals, 246-247 antibiotic resistance, 44, 89, 119, 125, 145-146 antibiotics, other, 144, 145, 228 APHIS notification process, 9, 108, 180 APHIS permits, 9-10, 110, 123-126 hybridization, 68 vaccines, 228, 229 Philippines, 34-35 Phosphorus, 22-22, 34 Phytoremediation, 229, 232-233 Plant Protection Act (proposed), 15-16, 101, 236, 253-254 Pollen, 32, 33, 39, 40, 67-68, 99, 113, 214, 244, 246, 256, 258 APHIS deregulation process, 150, 156, 165 APHIS notification process, 132-133, 181 APHIS permitting process, 124-125, 188 Bt, 7, 96, 150, 156, 165 insect vectors, 67, 156, 158, 214, 244, 255 Poplars, Bt, 69, 92, 145, 184, 222-223 Postcommercialization testing and monitoring, 12-14, 21, 168, 182, 189, 192-219, 256-257 APHIS, 12-14, 192-219 theoretical issues, 193-196 cost-effectiveness, 206, 209, 210, 257 DNA, 185, 214, 215 ecological indicators, general, 206, 208-213, 217-218 funding, 13, 14, 197-198, 202 invasive species, 195, 203, 205, 207, 216 non-target species, 196, 197, 214, 216 resistance evolution, 196 social factors, 195 spatial factors, 13, 14, 194-195, 197, 203, 206, 208, 209, 214-215, 217, 256 standards, 14, 209-213, 216 time factors, 193, 194-197, 206, 207-213, 217, 219, 256-257 trained-observer monitoring, 13, 205-207, 217-218, 219, 257 Potatoes, 43, 69, 118 Precautionary principle, 64-65, 66, 247-250 Precipitation, 24, 30 Public input, 9-10, 12, 104, 105, 118, 127, 135, 165-166, 168-175, 182, 188, 191, 212, 242-245, 290

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation see also Confidential business information; Federal Register Public opinion, 3, 15, 17, 18-19, 21, 212, 214, 237, 245 risk analysis, 58, 61, 64, 83, 195, 242, 252 R Radiation-induced mutagenesis, 42 Rainfall, see Precipitation Reference scenarios/comparative risk approach, 39, 87-99, 100, 122-123 Regulatory issues, 15-16, 21, 229, 245-254 see also Animal and Plant Health Inspection Service; Coordinated Framework for the Regulation of Biotechnology; Environmental Protection Agency; Food and Drug Administration; Legislation; Postcommercialization testing and monitoring; Risk analysis; Standards committee mission, 1-2 committee workshop agenda, 289-290 conventionally improved crops, 5, 20, 29, 62, 63, 79, 82, 83-86, 142, 143 extra-territorial regulation, 16, 56-57 historical perspectives, 3, 17-18, 19, 49-51, 57-58, 83 Office of Science and Technology Policy, 50, 80-81, 178 precautionary principle, 64-65, 66, 247-250 public input, 9-10, 12, 104, 105, 118, 127, 135, 165-166, 168-175, 182, 188, 191, 212, 242-245, 290 Reproductive sterility, 30, 33, 40, 52, 67, 102, 115, 116, 122, 150, 151, 181, 184, 223-224, 236, 258 Research methodology, 10 see also Case studies; Epidemiology; Experimental methods; Models and modeling; Risk analysis committee study at hand, 1-2, 7-8, 19-20, 295-299 Resistance see also Disease resistance; Herbicide resistance antibiotic resistance, 44, 89, 119, 125, 145-146 insects, resistance by, 7, 65, 76-77, 91; see also Resistance evolution insects, resistance to, by conventionally improved crops, 37, 38, 39, 41, 43, 129, 144-145, 153, 201, 220, 244; see also Bacillus thuringiensis viral, 104, 113, 116-117, 118, 126-135, 152, 159-160 Resistance evolution, 7 hazard identification, 65, 76-77 postcommercialization testing and monitoring, 196 weeds, 6, 65, 76-77, 100 Rice, 4-5, 32, 33, 226, 227 Bt, 70, 71 Green Revolution, 34-35 Risk analysis, 6-7, 12, 16, 49, 51, 52-100, 233, 242-243, 255-256 see also Experimental methods; Field testing; Postcommercialization testing and monitoring APHIS role, general, 6, 60, 81-87, 172, 252-254 committee conclusions and recommendations, 5, 6, 58, 61, 63, 64, 77, 82, 83, 85, 86, 90, 98, 99-100 committee mission, 1-2, 20 definitional issues, 53-56, 58-62, 65-77 epidemiology, 6, 59, 132, 217 European Union directive, 65, 66, 247-248 event-tree analysis, 90, 96-98 exposure pathways, 53, 66 fault-tree analysis, 12, 88, 89, 93-96, 190-191 hazard identification, 54-55, 59, 61, 63, 65-77, 169, 172, 218, 243, 255 historical perspectives, 2-3, 29-33, 36, 53, 71-76, 83 international perspectives, 56-57, 117 European Union directive, 65, 66, 247-248 precautionary principle, 64-65, 66, 247-250 litigation, 58, 74 Office of Science and Technology Policy, 50, 80-81 precautionary principle, 64-65, 66, 247-250 public input, 9-10, 12, 104, 105, 118, 127, 135, 165-166, 168-175, 182, 188, 191, 212, 242-245, 290

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation standards, 6-7, 59-61, 255 definitional issues, 53-56, 58-62 reference scenarios/comparative risk approach, 39, 87-99, 100, 122- 123 theoretical issues, 59, 61, 68, 98 definitional issues, 53-56, 58-62 two-part model, 90 two-part model, 90-92, 98 whole organism, 65, 68-70, 91-92, 98, 196 Risk Assessment in the Federal Government: Managing the Process, 53 RNA, 41, 46, 116-117, 185 Rural Development Act, 199 S Salinity, 35, 230 bermudagrass, salt-resistant, 120-123 soil, 5, 120-123, 222, 223 Secrets, see Confidential business information Seed dispersal, 37, 66, 69 Smith-Lever Act, 17 Social factors, 2-3, 4, 16, 29, 188, 223, 237, 252, 258-259 see also Public input; Public opinion international perspectives, 18 postcommercialization testing and monitoring, 195 risk analysis, 6, 8, 58, 61, 64, 83, 99 Soil and Water Resources Conservation Act, 199 Soil characteristics, 35, 144, 210, 244, 302 see also Fertilizer acid deposition, 24, 223 National Resources Inventory, 200 non-target organisms, 71, 73, 163, 204, 255 phytoremediation, 229, 232-233 reference scenarios, 88-89, 96-98 salinity, 5, 120-123, 222, 223 soil contamination, 33, 229 Soil Conservation Service, see Natural Resources Conservation Service, 199 Southern analysis, 114, 115-116 Soybean, 72, 90, 136-144, 224, 225-226, 290 Spatial factors, 252 see also Landscape effects APHIS permitting process, 124-125, 131, 179, 188-189 APHIS regulation, general, 8-9, 13, 103-104, 150, 176, 179, 184, 191 committee mission, 20 edge effects, 22, 27 isolated or related species, 48, 124-125 long-term effects, 2, 208; see also “postcommercialization…” infra minicommunities, 28-36 National Resources Inventory, 14, 199-200 notification process, 9, 109 postcommercialization testing and monitoring, 13, 14, 194-195, 197, 203, 206, 208, 209, 214-215, 217, 256 regional farming practices/systems, 15 Squash, 126-135, 160, 187 Standards, 3 APHIS evidential standards, 187 APHIS notification process, 109, 122 conventionally vs genetically improved crops, 5 ecological indicators, 14, 209-213 epidemiology, 6, 217 historical perspectives, 19 postcommercialization monitoring, 14, 209-213, 216 risk analysis, 6-7, 59-61, 255 definitional issues, 53-56, 58-62 reference scenarios/comparative risk approach, 39, 87-99, 100, 122- 123 risk minimization, 104 Sterility, see Reproductive sterility Sugar beet, 33, 67, 69 Synergistic effects, 114, 128, 130, 208, 235 T Taiwan, 32 Taxonomic factors, 30, 79, 112, 155, 208-209 Temporal factors, see Time factors Theoretical perspectives, 256, 302 APHIS postcommercialization monitoring, 193-196 extinction by hybridization, 68 risk analysis, 59, 61, 68, 98 definitional issues, 53-56, 58-62 two-part model, 90

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Threatened species, see Endangered and threatened species Time factors, 252 abiotic stress resistance, 230-231 APHIS notification and field testing, 9, 51, 108, 169, 173, 174 APHIS permitting, 111, 132 APHIS regulation, other, 102, 118-120, 135, 169 horizontal gene transfer, 67 long-term effects, 2, 14-15 National Resources Inventory, 14, 199-200 outflows from agroecosystems, 23-24 phenotypic trait array, 14-15 postcommercialization monitoring, 193, 194-197, 206, 207-213, 217, 219, 256-257 public response to assessment, 10 Tolerance, see Resistance; Resistance evolution Toxicology, 13, 23, 38-39, 117, 189, 252 see also Bacillus thuringiensis; Pesticides avidin, 9, 180-181 historical perspectives, 17-18 insect resistance, 38 Trade secrets, see Confidential business information Training, see Education and training Transcapsidation, 114, 128 Transcription (DNA), 40-41, 45, 46 Two-part model, 90-92, 98 U Understanding Risk: Informing Decisions in a Democratic Society, 53, 242-243 V Vaccines, 228, 229 Viruses, 106, 256 APHIS regulation, 104, 106, 109, 113-114, 116-117, 118, 126-135, 152, 159-160, 187 resistance, 104, 113, 116-117, 118, 126-135, 152, 159-160 vaccines, 228 Vitamins, 226, 227, 229 Volunteer monitoring organizations, 206 W Water quality, 22-23, 34-35, 107 see also Coastal zones; Fish and fish habitat; Irrigation; Salinity; Wetlands acid deposition, 24, 223 nitrogen deposition, 22, 24, 25-26, 34 nutrient runoff, general, 23-26 (passim), 210 Waterfowl, see Birds Weather see also Climate; Precipitation pollen dispersal by wind, 67 Weed Science Society of America, 113, 129, 148 Weediness, 30, 67, 69, 69-70, 79, 244 see also Herbicide resistance; Hybridization; Wild relatives APHIS assessments, 11, 104, 105, 113, 122, 130-133, 139-140, 142, 147-150, 160, 165, 178-179 sugar beet, 33 Weeds and weed management, 24, 26, 33, 69, 223, 302 APHIS regulation, 104, 105, 113, 122, 156-157 resistance evolution, 6, 65, 76-77, 100, 129; see also Herbicide resistance species feeding on, 204 Western blots, 116 Wetlands, 22-23 coastal zones, nitrogen deposition, 24, 25-26 outflows from agroecosystems, 24, 34 Wheat, 4, 33, 226 Green Revolution, 34 Whole-plant hazards, 65, 68-70, 91-92, 98 corn, 68-69 postcommercialization testing and monitoring, 196 Wild relatives, 32, 33, 41, 43, 67, 68, 69, 104, 105, 112, 113, 117, 123, 125, 247 see also Non-target species; Weediness APHIS deregulation process, 129-135 (passim), 149-153, 157, 160, 163 EPA regulation, 160-161 outcrossing, 33, 125, 140 World Health Organization, 56 World Trade Organization, 56-57 World Wide Web, see Internet

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Y Yield factors, 21, 29-30, 72, 144, 145, 186, 193-194, 240 as complex trait, 39, 41, 43 conventional breeding, 28, 37 Green Revolution, 34-35 honey, 31 monocultural systems, 24 sugar beet, 33

Representative terms from entire chapter:

postcommercialization testing