Index
A
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
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
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
spatial factors, 124-125, 131, 179, 188-189
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
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
time factors,
notification and field testing, 9, 51, 108, 169, 173, 174
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
Antibiotic resistance, 44, 89, 119, 125, 145-146
Antibiotics, other, 144, 145, 228
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
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
international perspectives, 163-164
poplars, 69, 92, 145, 184, 222-223
reference scenarios, 87, 89, 91-92, 93-94, 96-98
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
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
invasive species, 207
outflows from agroecosystems, 24, 26
Bt, see Bacillus thuringiensis
C
Cartagena Protocol on Biosafety, 248, 249
APHIS, 121-166, 177-178, 187, 189
Office of Science and Technology Policy, 178
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)
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
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
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
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
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
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 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
Enzymes, 37-38, 47, 136, 221, 236
ELISA, 116
Southern analysis, 114, 115-116
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
Green Revolution, 34-35, 250-251
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
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
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
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
reference scenarios, 98
viral resistance, 128
Geographic factors, see Spatial factors
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
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
Historical perspectives, 3, 4-5, 17-19, 21, 29-36, 77, 198-199, 203, 215, 220, 239, 250
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
integrated pest management, 164
risk analysis, 2-3, 29-33, 36, 53, 71-76, 83
Horizontal gene transfer, 43, 48, 66-67
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
wild relatives, 67-68
I
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
Bt cotton, 163-164
Convention on Biodiversity, 65, 248, 249
ecological indicator standards, 210
extra-territorial regulation, 16, 176, 247-250
outflows from agroecosystems, 24, 25, 26
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
drought, 37, 64, 121-123, 230, 231-232, 233-234
L
Landscape effects, 2, 22, 24, 27-28, 244
committee mission, 20
horticultural, 28
National Resources Inventory, 200
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
M
Maize, see Corn
edge effects, 27
as plant pests, 107
Methodological issues, see Epidemiology; Experimental methods; Models and modeling; Research methodology; Risk analysis
Migratory Bird Treaty Act, 198-199
Minerals, dietary, 224, 226-227
Minicommunities, 29-36
Models and modeling
see also Theoretical perspectives
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
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
backcrossing, 41-42, 43, 47, 98
conventionally improved crops, 37, 40-43
radiation-induced, 42
N
National Agricultural Statistics Service, 199, 200-201, 218
National Biological Impact Assessment Program, 170
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
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
P
Pathogen resistance, see Disease resistance
Pedigree breeding, 40
Peer review, 10, 168, 188, 198
Pesticides, 7, 22, 28, 35, 36, 144-145, 180
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
Philippines, 34-35
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
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
theoretical issues, 193-196
cost-effectiveness, 206, 209, 210, 257
ecological indicators, general, 206, 208-213, 217-218
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
time factors, 193, 194-197, 206, 207-213, 217, 219, 256-257
trained-observer monitoring, 13, 205-207, 217-218, 219, 257
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
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
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
definitional issues, 53-56, 58-62, 65-77
European Union directive, 65, 66, 247-248
event-tree analysis, 90, 96-98
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
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
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
whole organism, 65, 68-70, 91-92, 98, 196
Risk Assessment in the Federal Government: Managing the Process, 53
Rural Development Act, 199
S
bermudagrass, salt-resistant, 120-123
Secrets, see Confidential business information
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
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 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
isolated or related species, 48, 124-125
see also “postcommercialization…” infra
minicommunities, 28-36
National Resources Inventory, 14, 199-200
postcommercialization testing and monitoring, 13, 14, 194-195, 197, 203, 206, 208, 209, 214-215, 217, 256
regional farming practices/systems, 15
Standards, 3
APHIS evidential standards, 187
APHIS notification process, 109, 122
conventionally vs genetically improved crops, 5
ecological indicators, 14, 209-213
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
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
definitional issues, 53-56, 58-62
two-part model, 90
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 regulation, other, 102, 118-120, 135, 169
horizontal gene transfer, 67
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
historical perspectives, 17-18
insect resistance, 38
Trade secrets, see Confidential business information
Training, see Education and training
Transcription (DNA), 40-41, 45, 46
U
Understanding Risk: Informing Decisions in a Democratic Society, 53, 242-243
V
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
Volunteer monitoring organizations, 206
W
Water quality, 22-23, 34-35, 107
see also Coastal zones; Fish and fish habitat; Irrigation; Salinity; Wetlands
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
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
World Health Organization, 56
World Trade Organization, 56-57
World Wide Web, see Internet