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Pages 641-652

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From page 641...
... , 249, 377, 378, 482-483, 489, 565-566, 570-572 photochemical, 115,118, 138 stochastic, 9, 52, 55, 116, 138-139 Ambient concentrations, 45, 86, 114, 150151, 158 Animal studies, 26, 32, 58-60 cadmium, 100-101 carcinogens, 1, 2, 16, 59, 92-94, 9210O, 102, 229-231, 393, 395, 406409 dioxins, 102-103 extrapolation from, 2, 5, 32, 58-59, 8889, 1 19-12O, 142, 21O, 22O, 449451 carcinogenicity, 86, 88, 92-104, 120-126, 134, 140-142, 397, 435 436
From page 642...
... , 64 Benign tumors, 88, 121 Benzene, 32, 33, 42n, 198, 199, 317-321 Beryllium, 42n, 317 Bias, 162, 164, 165 Bioaccumulation, 37, 40, 51, 52 Biological markers, 45, 151-152 Butadiene, 479 C Cadmium, 100-101 California, 35, 114, 152 Cancer and carcinogens, 1, 2, 16-17 animal studies, 92-100, 102, 229-231 extrapolation from, 86, 88, 92-104, 120-126, 134, 140-142, 397, 435 436 classification, 10-11, 58, 59, 60, 126 131,142,252,421-427 dose-response relationship, 65-67, 85, 94-103, 236-237, 427-438 epidemiological studies, 1, 2, 16, 58, 88, 120, 207, 395, 398-404 individual species of suspect classes, 101-102 lifetime risk, 3, 19, 36, 250, 543, 552 553 mechanisms, 2-3, 9, 31, 98-99, 103, 104, 120-121, 123-126, 390-394 INDEX cell proliferation, 66-67, 99, 123, 228-229, 391-392, 415 multiple tumor risk, 13, 229-231, 240 241 regulatory approaches, 3, 17, 19, 31-33, 35, 36, 396 risk estimation, 69-70, 488-501, 552 553, 560-561, 567-568 guidelines, 34-35, 56, 87-88, 102, 236-237, 388-440, 600, 629 low-dose, 32, 85, 87, 228-229, 412 417 potency, 10, 102-103, 122-124, 126, 143, 265 unit risk estimate (URE) , 10, 94, 103, 122, 124, 143, 314, 323, 543 sites of tumor formation, 121, 141 susceptibility, 200, 201-203, 207, 218 219, 505-512 synergistic interactions, 227-228, 511, 512 threshold doses, 29, 31, 65-66 Carbon monoxide, 198 Cell proliferation, 66-67, 99, 123, 228229, 391-392, 415 Censuses of population, 113, 114 Central-tendency estimates (CTEs)
From page 643...
... , 109 Convolution model, 380 Criticisms of risk assessment, 5-6, 40-42, 256, 258 Cumulative distribution function (CDF) , 167-168 Cytochrome P450, 505-508, 510 D Data availability and quality, 9, 106, 137138, 333-434 emissions, 9, 110, 138, 147-149 exposure, 152, 328 pollutant transport and fate, 150 population data, 112-114 toxicity assessment, 154 Data bases activity patterns, 114 emissions, 147-148, 347-348 literature reviews, 10, 253, 265 management, 156-157, 159, 266 validation, 106, 107, 254, 255 643 see also Integrated Risk Information System; Toxic Release Inventory Data collection priorities, 10-11, 145-146, 154-158, 344-348 emissions, 147,155, 156 exposure, 145,150-152,155, 156 pollutant transport and fate, 149-150, 155, 156 toxicity assessment, 145, 153-154, 155, 156 Data needs, 6, 10-11, 79, 115, 144-145, 157-159 activity patterns, 114 emissions, 147-149, 158, 253, 591, 592 exposure, 150-152, 158, 594-596, 635 toxicity assessment, 152-154, 253, 265, 596-597 transport and fate, 149-150, 591, 593 594 see also Data availability and quality; Data collection priorities Database on Toxic Interactions, 227 Default options, 5, 7, 28-29, 32, 80-81, 85-87, 137-138 articulation of, 7, 8, 81, 87, 88-89, 104, 252, 254-255 criteria and principles, 6, 7, 8, 34, 79, 81-83, 87-90, 195 plausible conservatism, 7, 82, 83, 89, 601-626, 632-634 policy bases, 8, 81, 82, 87, 89, 104 scientific bases, 7, 8, 28-29, 82, 83, 87, 104, 610, 629-640 criticisms of, 6, 40-41, 254 departures from, 6, 7, 8, 28-29, 34, 79, 90-91, 105 criteria, 7, 8, 81, 90-91, 105, 254 255, 615-617, 629, 632-633 examples of, 92-104 petitioning, 267 scientific consensus for, 7, 8, 91, 105 and uncertainty analysis, 183-184, 185-186 extrapolation issues, 88, 90 animals to humans, 5, 88-89, 92-104
From page 644...
... , 233, 233-234 Exponential models, 107-109, 110 Exposure, see Aggregation; Doseresponse assessment; Exposure assessment; Routes of exposure; Threshold dose hypotheses; Toxicity assessment; Variability, In exposure Exposure assessment, 3, 5, 26-27, 43-45, 48-49, 329-331, 364 calculation, 44, 375-376
From page 645...
... , 9, 117-119, 139, 140, 247, 319, 378 379 long-term, 54-55, 544, 547, 549 554, 558-561, 564-569 population data, 112-114, 117, 118, 139-140, 379 short-term, 55, 380-381, 544, 547, 554-557, 562-563, 569-574 uncertainly issues, 71, 163 and variability, 6, 11, 20, 79, 189, 196 200, 203-206, 216, 217-218 see also Air-quality models; Emission characterization; Routes of exposure; Transport and fate Exposure Factors Handbook, 195 Exposure-response relationship, see Doseresponse assessment Extensive-hydroxylator phenotype, 200, 508 Extrapolation of data, 88, 90, 113, 220 among exposure routes, 134, 141, 450 animal to human, 2, 5, 32, 58-59, 8889, 119-120, 142, 210, 220, 449451 carcinogens, 86, 88, 92-104, 120126, 134, 140-142, 397, 435-436 see also Linearized multistage model 645 F Food Additive Amendments of 1958, Delaney clause, 17, 31 Food additives and contaminants, 30, 32 Food and Drug Administration (FDA) , 32 Food chain accumulation, see Bioaccumulation Formaldehyde, 96-99, 133, 198, 199 Fugitive emissions, 47, 108-109, 111, 545-546 G Gaussian-plume models, 8, 9, 51, 52, 115, 116, 118, 119, 138-139, 140, 247, 249, 264, 376-378 Genetic mutation, 231-234, 241 Genetic susceptibility, 11, 201-203, 219, 505-5 1 1 Geographic information systems (GIS)
From page 646...
... , 32 International Agency for Research on Cancer (IARC) , 32, 58, 59, 126, 129 Iterative risk assessments, 14, 84, 89, 146, 154, 155, 157-158, 253-254, 634 emissions characterization, 147, 247, 249-250 environmental fate and transport, 149150 exposure, 150-152, 247-250, 540-576 recommendations, 14-15, 263, 264, 266, 267 toxicity, 153-154, 250-251 L Lagrangian models, 52, 118, 138 Lead, 8 Lesser quantity emission rates (LQERs)
From page 647...
... enzymes, 95-96 Mobile sources, 10, 20, 262, 268 Mobility and migration, 45, 54, 113, 118, 119, 139, 205, 217-218 Models and modeling, 9, 107-112, 137138. See also Air-quality models; Animal studies; Default options; Dose-response assessment, modeling; Exposure assessment, modeling; Linearized multistage model; Model uncertainty; Parameter uncertainty; Pharmacokinetic models; Validation and evaluation Model uncertainty, 7, 11-12, 80, 83, 86, 87, 90, 165-166, 171-175, 185, 239 Molecular toxicology, 11, 143, 207, 219 Monitoring programs and methods, 26, 44-45, 109, 110-111, 150-151, 152 personal dosimeters, 44, 49, 151, 158 647 Monte Carlo models, 52, 177, 206, 330, 500 Moolgavkar-Venzon-Knudson model, 123, 195, 211 Multimedia risk assessment model, 453 461 Multiple exposure, see Aggregation Multiplicative models, 107, 109, 111 Mutagenesis, 231-234, 241 N N-acetylation polymorphism, 200, 508 National Ambient Air Quality Standard (NAAQS)
From page 648...
... , 506-507, 508 Polymorphic phenotypes, 200, 505-510 Population data and models, 112-114, 117, 118, 139-140, 379 mobility, 45, 54, 113, 118, 119, 139, 205, 217-218 Population risk, 70, 209-210, 218, 371-372 children, 11, 210-211, 220, 252, 511 subgroup exposure and susceptibility, 11, 114, 191, 205, 253, 372-373 uncertainty and variability, 239-240, 531-532 Potency estimates, 10, 27, 38, 102-103, 122-124, 126, 143, 265 uncertainty analysis, 10, 143, 162 unit cancer risk, 10, 103, 122, 124, 143 variability, 189, 193, 218-219 Probability density function (PDF) , 167 168, 171-175, 184, 186 Probability distributions, 161, 167- 178, 180, 184, 454 generation of, 175-177, 465-467 subjective, 83, 170-171, 177, 178 Process-vent emissions, 47, 109 Public criticisms, see Criticisms of risk assessment R Race and ethnicity, 7, 114, 219 Radiomimetic activity, 2, 9, 31, 103, 125
From page 649...
... , 35 Risk Assessment and Management Commission, 19, 82, 600 Risk Assessment in the Federal Government: Managing the Process, see Red Book Risk characterization and communication, 5,23,27,68,78,80, 181, 183, 439-440, 630-631 and aggregation, 234-240, 530-534 EPA (Habicht) memorandum, 68, 7678, 351-374 full disclosure, 77, 352-353, 355, 361367 to managers, 13, 78, 80, 83-84, 310312, 614-615, 630-632 presentation of estimates, 69-70, 76-78, 83-84, 351-374, 624-625 649 professional judgment, 77, 354 to public, 78, 144-145, 194, 252 recommendations, 13- 14, 263 uncertainty analysis, 12, 15, 20, 27, 41, 70-75, 78, 83-84, 174, 180, 235240, 263, 310-312, 362, 365-366 use of multiple descriptors, 77, 353354, 355, 367-374 of variability, 11, 194, 212-213, 214215, 221 Risk management, 18, 19, 28, 32, 41-42, 349-350, 360-361, 630-632 communication of risk to, 13, 78, 80, 83-84, 310-312, 614-615, 630-632 risk-reduction strategies, 196, 262 safety-factor approach, 30-31 separation from risk assessment, 5, 34, 77, 259-260, 267-268, 355, 358360, 623 and uncertainty analysis, 41, 166-167, 171-175, 179-183 Risk ranking, 27, 37, 171, 183, 186-187, 296,315,325-326,617 Rodents, 122, 141, 143 Routes of exposure, 10, 26-27, 43-44, 119, 140 extrapolation among, 134, 141, 450 multiple, 13, 41, 51-52, 119, 225-226, 240, 252 noninhalation, 10, 44, 119, 140, 226 and site of tumor formation, 121 S Safety-factor method, 30-31, 62-63, 224 Sampling, 109, 151 Science Advisory Board (SAB)
From page 650...
... , 30 Tiered modeling approach, 243-244, 326327, 329. See also Iterative risk assessments Time-activity patterns, 47, 53, 114 Total Exposure and Assessment 410-411 Subjective probability distributions, 83, 170-171, 177, 178 Subpopulation exposures and risk, 11, 114, 191, 205, 253, 372-373 Superfund Amendments and Recovery Act (SARA)
From page 651...
... , 10, 94, 103, 122, 124, 143, 314, 323, 543 Unleaded gasoline, 92 V Validation and evaluation, 6, 8-10, 79, 106-107, 136-143, 254-255 air-qualify models, 114-119, 138-139 data bases, 106, 107, 254, 255 651 exposure models, 49-50, 114, 139- 140, 264 extrapolation of animal studies, 119 136, 140-142, 212 Variability, 11, 188-191, 189, 195, 196, 221n in biological characteristics, 211-212, 220 communication of, 11, 194, 212-213, 214-215, 217-221 disaggregation, 191-192, 194 in emissions, 189, 197-199 in exposure, 6, 11, 20, 79, 189, 196 200, 203-206, 216, 217-218 activity patterns, 196, 199-200, 217 ignoring, 191, 194, 220 intraindividual, 11, 189 management strategies, 191-196 in potency, 189, 193, 218-219 spatial, 191-192, 197-198 in susceptibility, 6, 11, 40, 79, 206-210, 216-217, 218-221 to cancer, 200, 201-203, 207, 218 219, 505-512 defaults, 11, 207-209, 219-220, 222n, 252 distributions and dichotomies, 201 203, 206-210, 503 factors in, 200-201, 503-512 identifiable, 196, 213, 216-217, 503 temporal, 191, 197-198 end uncertainly, 11, 162, 164, 180-181, 187n, 213, 221, 237-240, 242 use of averages, 192-193, 194, 195-196 use of high end values, 193, 195-196, 217 Variance-component model, 380-381 Vinyl chloride, 42n, 133-134, 317, 320 Volatile organic compounds (VOCs) , 111, 148, 149, 150 W Weight of evidence (WOE)


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