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Index A Acaricides, 52-53, 204; see also Chlorobenzilate Acceptable Daily Intake (ADI), calculation of, for non-oncogenic pesticides, 31-32 Acephate crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 84 Q* for, 55, 77 risk reduced through tolerance revocations, 115 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Acetamide, 88, 93-94, 222-224 Acifluorfen, 47, 52 Acre treatments definition, 47 lost under policy scenarios, 107, 111, 114, 116, 122, 124-129 with oncogenic fungicides, 48, 122, 125-128 with oncogenic herbicides, 122, 124 with oncogenic insecticides, 47-48, 122, 124-125 257 Active ingredients, see Pesticide active ingredients Alachlor crop uses, 52, 68, 76, 89 dietary oncogenic risk from, 68, 76, 83, 84, 89, 98 herbicide market share, 98 possible date for tolerance revocation, 98 potential short-term impact of Delaney Clause on, 98 Q* for, 55, 76 risk reduced through tolerance revocations, 110, 121 TMRC, 76 use cancellations, 68 volume of use, 47, 89 weight-of-the-evidence classification, 67, 76 year of first tolerance, 52, 68 Alar, see Daminozide Aliette, see Fosetyl Al Allelopathy, 231-232 Ambush, see Permethrin Amitraz application of Delaney Clause to, 88, 90 dietary oncogenic risk from, 88 major crop uses, 52 volume of use, 52
25~3 INDEX year of first tolerance, 52 Ammo, see Cypermethrin Animal drugs, applicability of Delaney Clause to, 38 Animal feeds commodities affected by pesticide residues in, 74 concentration of residues in, 37, 40, 73 effect of loss of crop tolerances for, 120 estimated oncogenic risk from residues in, 71-74 not subject to feed-additive regulations, 73 problems posed by, 110 Animal products concentration of residues in, 37, 93-94 Delaney Clause effect on, 73 dietary oncogenic risk from 119-120 effect of risk reduction strategies on, 119 problems posed by, 110 sensitivity-of-the-method procedure applied to, 88, 93-94, 223-224 Animal studies of oncogenicity/ carcinogenicity, relevance to humans, 30, 33, 38, 49-50, 66, 67 Apples consumption estimates, 57-58 effect of policy scenarios on, 107, 111, 11~116, 125-126 estimated oncogenic risk from, 78, 80, 85, 133-134 pesticide use levels on, 48, 52 risk reduced by tolerance revocations, I22 tolerance denials for, 88, 90 vulnerability to tolerance revocations, 10 Arsenic acid, 52 Asulam exclusion from this study, 51 major crop uses, 52 Q* for, 55 volume of use, 52 year of first tolerance, 52 Atrazine, 47 Azinphos-methyl crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 84 Q* for, 55, 77 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 B Baam, see Amitraz Bacillus thuringiensis, 153-154, 239-242, 246-247 Baculovirus, 151-152 Beef, estimated oncogenic risk from, 78-79, 84 Benlate, see Benomyl Benomyl alternatives to, 201-202 application of Delaney Clause to, 95-97, 132, 199-200 concentration in processed foods, 19, 95 crop uses, 52, 68, 77, 89 dietary oncogenic risk from, 68, 77, 85, 89, 97, 132, 134, 199 fungicide market share, 97, 132 metabolite, 199 number of tolerances, 109 pest resistance to, 200 possible date for tolerance revocation, 97, 132 Q* for, 55, 77 regulatory status, 198 risk reduced through tolerance revocation, 109-110, 113, 115, 12~121, 132-133 TMRC, 77 tolerances, 198, 199~200 volume of use, 52, 89, 95, 198 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Biological pest control allelopathy, 231-231 innovation prospects in, 9, 153-154 weed control by insects, 23~231 Biotechnology, innovations in, 9 Blazer, see Acifluorfen Bravo, see Chlorothalonil C Calcium arsenate, 52 Cancer background risk, 3 induction, evidence of, 38 Captafol crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 83, 85, 97, 132-134 fungicide market share, 97, 132 possible date for tolerance revocation,
INDEX 259 97, 132 potential impact of Delaney Clause on, 97, 132 Q* for, 55, 77 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Captan crop uses, 52, 68, 77, 89 dietary oncogenic risk from, 68, 77, 83, 85, 89, 97, 132, 134, 202-203 fungicide market share, 97, 132 non-oncogenic health risks, 201 possible date for tolerance revocation, 97, 132 potential impact of Delaney Clause on, 97, 132, 203 Q* for, 55, 77 regulatory status, 201 risk reduced through tolerance revocation, 109-110, 121 TMRC, 77 tolerances, 201, 203 volume of use, 52, 89, 201 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Carcinogenicity determination of, 39 distinction between oncogenicity and, 3, 30-31 Carcinogens definition, 30, 31 EPA classification system for, 4, 31, 66, 67 negligible-risk standard for, 12-14 Case studies for potential policy precedents benomyl, 95-96, 198-201 captan, 201-204 chlorobenzilate, 95, 204-205 dicamba, 94-95, 206-208 dicofol, 95 EBDCs, 208-214 fosetyl Al, 192, 196-198 metalaxyl, 214-217 new active ingredients, 95-96 permethrin, 92-93, 217-220 prior-sanctioned pesticides, 91-92 thiodicarb, 93-94, 22~224 tolerances for new active ingredients, 91 Cattle, relevant pesticide use levels, 51, 53 Chlordimeform crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 74, 75, 76, 77, 83, 84, 125 Q* for, 55, 77 risk reduced through tolerance revocation, 121 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Chlorobenzilate alternatives to, 205 application of Delaney Clause to, 205 benefits of, 205 dietary oncogenic risk from, 89, 95, 204-205 major crop uses, 52, 89, 95 regulatory status, 204 tolerance actions on, 95, 205 volume of use, 52, 89, 204 year of first tolerance, 52 Chlorothalonil crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 83, 85, 97, 132-134 fungicide market share, 97, 132 possible date for tolerance revocation, 97, 132 potential short-term impact of Delaney Clause on, 97, 132 Q* for, 55, 77 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Citrus consumption estimates, 57-58 pesticide use levels on, 48, 52-53, 89 vulnerability to tolerance revocations, 10 Code of Federal Regulations, tolerances for oncogens, 19, 35, 36 Commodities, processed concentration of residues in, see Concentration of pesticide residues data sources on, 183-184 definition of, 42, 73, 110 dried, 37 estimated risk associated with, 5, 75, 85-86 estimation of residues in, 61-63, 185-186, 190-191
260 INDEX from minor crops, 10 pesticide residues as food additives in, 25-26, 35 risk standards applied to oncogenic pesticides in, 40 with section 409 tolerances for oncogenic pesticides, 4, 61-63 without section 409 tolerances for oncogenic pesticides, 5, 61-63 in TAS compared with section 409 tolerances, 64 Commodities, raw adulterated, 25 estimated risk associated with, 5, 86 estimation of residues in, 185-186, 190-191 risk standards applied to oncogenic pesticides in, 40 with no processed form, 5, 41-42, 7~72, 108, 110, 117 Concentration of pesticide residues in animal feeds, 37, 40, 73 in animal products, 37, 93-94 authority governing, see FDC Act, section 409 basis for determining, 37 Delaney Clause application to, 28 EPA tolerance-setting policy on, 2, 28, 41 examples, 19 impact on distribution and character of dietary oncogenic risk, 81-82 regulatory implications, 19-20, 27, 28, 35-37, 40 risk standards for, 40 TAS conversion factors for, 62 in tomato products, 81-82 Copper arsenate, 52, 56 Corn consumption estimates, 57-58 effect of policy scenarios on, 107, 111, 114, 115-116, 124 estimated oncogenic risk from, 15, 78, 79 oncogenic risk associated with, 15 pesticide use levels on, 52-53, 89 risk reduced by tolerance revocations, 122 tolerances for processed forms, 64, 219 Cotton effect of policy scenarios on, 107, 111, 114-116 pesticide use levels on, 52-53, 89 Crop-level scenario analyses apple fungicides, 107, 111, 114-116, 122, 125-126, 147-148 citrus insecticides, 146 coding for this study, 184-185 corn herbicides, 107, 111, 114-116, 122, 124, 129, 146-147 cotton insecticides, 107, 111, 114-116, 122, 124-125, 129, 146 data sources on, 184 grape fungicides, 105, 107, 111, 114, 116, 122 peanut fungicides, 7, 105, 107, 110-111, 114, 116-117, 122, 128-129, 147-148 potato fungicides, 105, 107, 111, 114-116, 122, 126-127, 147-148 prospects for innovation in, 145-148 selection of, 102 soybean herbicides, 107, 111, 114, 116-117, 122, 124, 129, 146-147 tomato fungicides, 107, 111, 114-116, 122, 127-128, 147-148 Crops distribution of dietary oncogenic risk by, 76, 78-83 herbicide-resistant, 152, 232-233 losing tolerances under policy scenarios. 106, 109-110, 113-116 not dependent on pesticides, 49 orchard, pesticide use levels on, 52-53 requiring processing studies under EPA guidelines, 70 see also Commodities, raw; Minor crops; specific crops Cultural pest control, prospects for innovation in, 9, 154-155 Cymbush, see Cypermethrin Cypermethrin application rates, 47 crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 84 Q* for, 55, 77 risk reduced through tolerance revocation, 121, 124-125 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Cyromazine application of Delaney Clause to, 88, 90 crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 88 Q* for, 55, 77 TMRC, 77
INDEX 26 1 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 D 2,4-D, 47, 137 Daminozide, 51, 52, 89 Delaney Clause constituents policy on, 39, 88, 90, 94, 207-208 de minimis interpretation, 39-40, 89, 95 DES Proviso, 38, 22~225 EPA interpretation of, 20, 30, 38, 83, 85-91, 196-224 economic effects, 136 exemptions from, 5, 26-27, 41-42, 70-72, 91-92, 107-108 FDA interpretation of, 30, 37~0 general safety clause, 26, 39, 40, 41, 9~95, 207 interpretation of, 20, 30, 37~0, 83, 85-91 legislative history, 38, 161-173 pest resistance and, 10-11 problems and issues posed by, 40-43 regulatory impacts of, 61, 69-70 requirement for proof of carcinogenicity, 31 responsibility for implementing and interpreting, 12 risk standard of, 22, 26, 35 scope of, 1-2 worst-case impact of, 71 Delaney Clause application to already-registered pesticides, 35, 95-96 to animal drugs and feed additives, 38 case studies of, 196-224 to concentrating residues, 28 to fungicides, 8, 97-98 to new pesticides, 2, 36, 86-96, 107-108 Delaney Clause effects on animal products, 73 on dietary oncogenic risk, 5, 69-70 on EPA decision making, 4 on fungicides, 97-98 on herbicides, 98 on minor crops, 71, 157 on pesticide availability, 20 on R&D, 9-10, 137, 140, 149-150 short-term, 97-98 Diallate, 52 Dicamba application of Delaney Clause to, 88, 90, 94-95, 206-208 benefits, 208 dietary oncogenic risk associated with 88, 94-95, 206-207 tolerances, 206 volume of use, 206 Diclofop methyl crop uses, 52, 68, 76 dietary oncogenic risk from, 68, 76 Q* for, 55, 76 TMRC, 76 volume of use, 52 weight-of-the-evidence classification, 67, 76 year of first tolerance, 52, 68 Dicofol, 52, 89, 95 Dietary exposure to pesticides complications in determining, 61 conservatisms in calculating, 32 estimation of, 56-63 sources of data on, 181-182 variables in, 49 see also Theoretical Maximum Residue Contribution (TMRC) Dietary oncogenic risk by active ingredient, 75-77, 83-84; see also specific active ingredients analysis of estimates, 66-83 chemical pesticide prospects relative to, 148-150 by commodity, 5, 75-76, 78-86; see also specific commodities from concentration of residues, 81-82 from current EPA policy, 12-13 by date of tolerance, 85-86 distribution in food supply, 4-6 effect of Delaney Clause on, 5, 69-70 expression of, 34 extrapolation from animal studies, 30, 33, 38, 49-50, 66, 67 increase through tolerance revocation/ denial, 8, 1~15, 20, 41-42, 126, 127, 131-134 from minor crops, 10 negligible-risk scenarios of, 6-7, 12-14, 104, 110-114 from old pesticides, 11, 85 by pesticide type, 8, 69, 74-77, 79-82, 84-85 from replacement chemicals, 76 from residues in animal feeds, 71-74 by tolerance type, 67-71, 85-86
262 INDEX zero-risk scenarios of, 6-7, 13-14, 103-110 Dietary oncogenic risk estimation acreage treated in, 187, 192-194 active ingredients included in, 4 analytical method, 3, 15-16, 21, 50-63, 185-195 assumptions in, 3, 33-34, 49, 65 balancing of benefits in, 18, 3~35, 43 benefits characterized for, 4 bias in, 60 confidence limit, 34, 54 conservatisms in, 33-34, 59, 65 crop-level analyses, 7, 102-117, 187, 193 data base, 4, 21, 50-55, 57-59, 176-185 data management system, 174-176 dietary exposure calculations in, 32, 56-63, 186 EPA method for, 3; see also Quantitative risk assessment food consumption estimates in, 57-59, 186, 191-192 formula, 63, 186-187 potency factor, see Oncogenicity potency factor (Q*) problems, 49-50 residues in commodities, 61-63, 185-186. 190-191 sources of data in, 178-185 transfer and transformation of files for, 176-178 treatment of malignant and benign tumors in, 3, 38-39, 50, 54 uncertainties in, 3, 4, 18, 33-34, 50, 190-195 weight-of-the-evidence approach, 3, 66, 101 see also Scenarios for regulating oncogenic pesticides Dietary oncogenic risk reduction in crop-level analyses, 7, 102-103, 105-107, 110, 113-117 through cropwide tolerance reduction, 131-134 in negligible-risk scenario 3, 112-114, 122 in negligible-risk scenario 4, 115-117, 122 by pesticide type in scenarios, 118-120, 124-129 in zero-risk scenario 1, 104-105, 122 in zero-risk scenario 2, 108-110, 122 Difolatan, see Captafol Dimethoate, 188 Dimethylnitrosamine, 88, 94-95 Dithane M-45, see Mancozeb Dual, see Metolachlor E EBDCs (ethylenebisdithiocarbamates) alternatives to, 214 application of Delaney Clause to, 212-214 dietary oncogenic risk from, 68, 77, 89, 92, 198, 210-212 effect of cropwide tolerance reductions on risk from, 133-134 major crop uses, 89 market life, 137 metabolite, see Ethylenethiourea regulatory status, 209-210 tolerances, 209, 212 volume of use, 89, 209 see also Mancozeb; Maneb; Metiram; Zineb Environmental Protection Agency (EPA) analytical framework recommended for, 15-16 classification system for carcinogens, 4, 31, 66, 67 Data Call-In Program, 36-37, 96-97 definition of processed feed, 73 definition of processed food, 42 difficulties in reaching and defending regulatory decisions, 22 food consumption data bases, see Food Factor system; Tolerance Assessment System (TAS) interpretation of the Delaney Clause, 4, 20, 30, 38, 83, 85-91, 19~224 regulation and review of pesticides, 100-101 regulatory actions scheduled for next 10 years, 5, 85-86 responsibilities in regulating pesticides, 18-19, 21-22, 25-26 EPA policy on application of Delaney Clause to new pesticides, 2, 86-91, 107-108, 131 case studies for potential precedents, 91-96 coordination with FDA in, 12 current dietary oncogenic risk estimation, 3, 12-13, 33-35, 50; see also Quantitative risk assessment on suspect oncogens, 5~51 for tolerance setting, 2, 27-36
INDEX 263 tolerances for oncogenic pesticides, 34 Ethalfluralin crop uses, 52, 68 dietary oncogenic risk from, 68, 76 Q* for, 55, 76 TMRC, 76 volume of use, 52 weight-of-the-evidence classification, 67, 76 year of first tolerance, 52, 68 Ethylene oxide, 52, 56 Ethylenethiourea, 68, 77, 198, 209-214 F FDC Act basic goals of, 18 divergences between FIFRA and, 19 EPA responsibilities under, 18-19, 25 Food Additives Amendment of 1958, 162, 164-166 Pesticide Residues Amendment of 1954, 161-162, 165-166 tolerance setting under, 24-36 FDC Act, section 201(s), definition of food additive, 25 FDC Act, section 402, standard for pesticide residues in processed foods, 26-27, 161-163, 166-170 FDC Act, section 408 EPA responsibilities under, 25 scope of, 1, 25 tolerance setting for non-oncogenic pesticides under, 31-33 tolerance setting for oncogenic pesticides under, 33-35 see also Tolerances, raw commodity (section 408) FDC Act, section 409 EPA's regulatory responsibilities under, 25-26 FDA responsibilities under, 25 general safety clause, 26, 39, 40, 41, 94_95, 207 prior-sanction exception to, 91-92 scope of, 1, 25 tolerance setting under, 35-36 see also Delaney Clause; Tolerances, processed commodity (section 409) Feed additives, applicability of Delaney Clause to, 38 FIFRA basic goals of, 18 divergences between FDC Act and, 19 EPA responsibilities under, 18 1972 amendments to, 139, 156 registration of pesticides under, 2, 23-24 section 3, 24 Fodders, risk standard applied to oncogenic pesticides in, 40, 73 Folpet crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 83, 85, 97, 132, 132, 134 fungicide market share, 97, 132 possible date for tolerance revocation, 97, 132 potential short-term impact of Delaney Clause on, 97, 132 Q* for, 55, 77 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Food additives definition, 25, 91 FDA interpretation of, 39 general safety clause, 26, 39, 40, 41, 94-95 regulation of pesticides in processed foods as, 26 unsafe, 26 Food and Drug Administration (FDA) benchmark for judging safety, 39 constituents policy, 39, 88, 90, 94, 207-208 coordination with EPA on policy, 12 de minimis standard, 39-40, 89, 95 interpretation of "additives," 39 interpretation of Delaney Clause, 30, 37-40 responsibilities under FDC Act, section 409, 25 sensitivity-of-the-method procedure, 38, 40, 73, 88, 90, 93-94, 223-224 Food consumption comparison of raw and processed crops, 58 estimates of, 57-59, 191-192 sources of data on, 179-181 Food Factor system, TAS contrasted with, 57-59 Fosetyl Al application of Delaney Clause to, 88, 92, 197-198 crop uses, 52, 68, 77, 92 dietary oncogenic risk from, 68, 77, 88,
264 INDEX 92, 197 Q* for, 55, 77 TMRC, 77 tolerances, 196-198 volume of use, 52, 196, 198 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Fruits as animal feeds, 72 dependency on pesticides, 49 importance of fungicides in production of, 8 pesticide use levels on, 52-53, 89 see also Citrus Fundal, see Chlordimeform Fungicides action, 129-130 benefits of, 7-8, 129 Delaney Clause impacts on, 8, 97-98 historical perspective on R&D in, 144-145 innovation in, 8-9, 125, 128, 129, 131, 145, 147-148 non-oncogenic, 8, 125, 127-129, 131 number of CFR tolerances for, 19, 35, 36 percent oncogenic, 4, 8, 14, 48 pest resistance to, 10, 130, 200 problems of, 130 R&D expenditures, 129, 149-150 sales of, 5, 14, 129 toxicity of, 145 use for major food commodities, 48 volume of use, 5, 48, 49 see also Crop-level scenario analyses; specific active ingredients Fungicides, oncogenic acre treatments, 48, 122, 125-128 active ingredients affected by policy scenarios, 106-107, 109-111, 113-114, 116 estimated risk from, 5, 8, 69, 74-75, 77, 80, 81, 85, 120, 129-130 expenditures, 48, 105, 107, 111, 114, 116, 122, 125-128 forecasting applications of, 126-127 major crop uses, 52-53 number, 36, 56 old, 85 risk reductions in policy scenarios, 105, 107, 108, 111, 112, 114-117 substitutes for, 106, 125-127, 130-131, 200-201, 214 TMRCs for, 60 tolerance revocations under policy scenarios, 105-107, 109, 111, 113-114, 116, 122, 125-128 volume of use, 48, 52-53 weak, 10, 95 worst-case impact of Delaney Clause on, 71 year of first tolerance, 52-53, 85 G Galecron, see Chlordimeform Genetic engineering bacterial insecticides, 239-243 fungal insecticides, 245-246 innovation prospects in, 151-152, 246-247 insect control through, 238-247 viral insecticides, 243-245 weed control through, 232-233 Gluthion, see Azinphos-methyl Glyphosate crop uses, 52, 68, 76 dietary oncogenic risk from, 68, 76, 84 Q* for, 55, 76 risk reduced by tolerance revocations, 113, 121 TMRC, 76 volume of use, 47, 52 weight-of-the-evidence classification, 67, 76 year of first tolerance, 52, 68 Gramoxone, see Paraquat Grapes effect of policy scenarios on, 105, 107, 111, 114, 116 estimated oncogenic risk from, 78, 80 pesticide use levels on, 53 risk reduced by tolerance revocations, 122 tolerances for processed forms, 64 vulnerability to tolerance revocations, 10 H Hays pesticide use levels on, 52 risk standard applied to oncogenic pesticides in, 40, 73 Herbicides historical perspective on R&D in, 144 innovation in, 9, 129, 146-147, 228, 230 low-application-rate, 229
INDEX 265 non-oncogenic, 131, 144 number of CFR tolerances for, 19, 35, 36 percent oncogenic, 4 potential short-term impact of Delaney Clause on, 98 R&D expenditures for, 149-150 volume of use, 228, 229 see also Crop-level scenario analyses; specific active ingredients Herbicides, oncogenic acre treatments, 122, 124 active ingredients affected by policy scenarios, 106-107, 109-111, 113-114, 116 estimated risk from, 5, 69, 74-76, 79, 82, 84, 85 expenditures, 46, 105, 107, 111, 114, 116, 122, 124, 144 major crop uses, 52-53 number, 36, 56 old, 85 risk reductions in policy scenarios, 105, 107, 108, 111, 112, 114-117, 124 substitutes for, 106, 124, 131 TMRCs for, 60 tolerance revocations under policy scenarios, 105-107, 109, 111, 113-114, 116 volume of use, 46~7, 49, 52-53 worst-case impact of Delaney Clause on, 71 year of first tolerance, 52-53, 85 Hoelon, see Diclofop methyl Hormones, juvenile insect, for pest control, 154, 235, 238 I Imidazolinone, 144 Innovations in pest control challenges to, 155-158 economic incentive for, 145 effect of Delaney Clause on, 9-10 indicators of rates and trends in, 142 in insect control, 234-247 for minor crops, 10 nonchemical, 9, 150-155 pesticides, 8-9, 125, 128-129, 131, 137 process, 137-139 prospects for, 145-148, 150-155 role in pesticide regulatory action, 226 trends, 226-247 in weed control, 228-233 see also Research and development in pest control Insecticides amidinohydrazones, 237 avermectins, 236-237 bacterial, 239-243 benzoylphenylureas, 237 cancellation of uses of, 51, 56 estimated dietary risk from, 5 fungal, 245-246 historical perspective of R&D in, 142-144 innovation in, 9, 129, 146-147, 23~247 insect hormones, 235 low-application rate, 234 milbemycines, 236-237 number of CFR tolerances for, 19, 35 octopamine agonists, 236 organochlorine, 138, 142, 234 percent oncogenic, 4, 47, 56 plant products as, 235, 238 proinsecticides, 237-238 R&D expenditures, 149-150 trioxabicyclo[2,2,2]octanes, 236-237 viral, 243-245 see also specific active ingredients Insecticides, oncogenic acre treatments, 47-48, 122, 124-125 active ingredients affected by policy scenarios, 106-107, 109-111, 113-114, 116 estimated risk from, 5, 69, 7~77, 79, 82, 84, 85 expenditures, 48, 105, 107, 111, 114, 116, 122, 12~125 number, 36, 56 risk reductions in policy scenarios, 105, 107, 108, 111, 112, 114-117, 122 substitutes for, 106, 124 synthetic pyrethroid, 47, 52, 55, 68, 77, 84, 142-143, 234, 237 TMRCs for, 60 tolerance revocations under policy scenarios, 105-107, 109, 111, 113-114, 116 worst-case impact of Delaney Clause on, 71 International Agency for Research on Cancer, 66
266 INDEX Kelthane, see Dicofol Kerb, see Pronamide K L Lannate, see Methomyl Larvadex, see Cyromazine Larvin, see Thiodicarb Lasso, see Alachlor Lead arsenate, 52 Liability for minor crop failures or crop injury, 10, 155-156 Lindane, 52, 56 Linuron crop uses, 52, 68, 76 dietary oncogenic risk from, 68, 74, 75, 82, 83, 84, 98 herbicide market share, 98 possible date for tolerance revocation, 98 potential short-term impact of Delaney Clause on, 98 Q* for, 55, 76 risk estimate approaches for, 66 risk reduced through tolerance revocations, 110, 121, 124 TMRC, 76 volume of use, 47, 52 weight-of-the-evidence classification, 67, 76 year of first tolerance, 52, 68 Lorox, see Linuron M Maleic hydrazide, 52 Mancozeb crop uses, 52, 68, 77 dietary oncogenic risk from, 68, 77, 83, 85,97, 132 fungicide market share, 97, 132 possible date for tolerance revocation, 97, 132 potential short-term impact of Delaney Clause on, 97, 132 Q* for, 55, 77 risk reduced through tolerance revocations, 127 TMRC, 77 volume of use, 52 weight-of-the-evidence classification, 67, 77 year of first tolerance, 52, 68 Maneb crop uses, 53, 68, 77 dietary oncogenic risk from, 68, 77, 97, 132 fungicide market share, 97, 132 possible date for tolerance revocation, 97, 132 Q* for, 55, 77 risk reduced through tolerance revocations, 110, 120-121 TMRC, 77 volume of use, 53 weight-of-the-evidence classification, 67, 77 year of first tolerance, 53, 68 Meat estimated oncogenic risk from, 73-74, 94 red, consumption estimates, 57-58 Metalaxyl Application of Delaney Clause to, 216 dietary oncogenic risk from, 215-216 effectiveness, 127 potential uses of and alternatives to, 216-217 regulatory status, 215 tolerances, 215, 216 volume of use, 214 Methanearsonic acid, 53 Methomyl, 53 Metiram crop uses, 53, 68, 77 dietary oncogenic risk from, 68, 77, 83, 85,97, 132 fungicide market share, 97, 132 possible date for tolerance revocation, 97, 132 potential short-term impact of Delaney Clause on, 97, 132 Q* for, 55, 77 TMRC, 77 volume of use, 53 weight-of-the-evidence classification, 67, 77 year of first tolerance, 53, 68 Metolachlor crop uses, 53, 68, 76 dietary oncogenic risk from, 68, 76 Q* for, 55, 76 risk reduced by tolerance revocations, 113, 121 TMRC, 76 volume of use, 47, 53 weight-of-the-evidence classification, 67,
INDEX 267 76 year of first tolerance, 53, 68 Milk and dairy products consumption estimates, 57-58 estimated oncogenic risk from, 79, 94 oncogenic risk from, 73-74 Minor crops challenges to innovation posed by, 155-157 dietary oncogenic risk from, 10 liability problems with, 10, 155-156 pesticide registration fees, 156 tolerances for, 155 USDA InterRegional Project 4 for, 156-157 vulnerability to tolerance revocations, 10, 71 with processed forms, 10 Mutations of biological insecticides, 241 N National Food Processors Association, 72 Paraquat Nuclear polyhedrios viruses, pest control with, 154 o O-Phenylphenol crop uses, 53, 68, 77 dietary oncogenic risk from, 68, 77, 85 Q* for, 55, 77 volume of use, 53 weight-of-the-evidence classification, 67, 77 year of first tolerance, 53, 68 Oncogenicity data necessary to support a finding of, 38 distinction between carcinogenicity and, 3, 30-31 see also Dietary oncogenic risk Oncogenicity potency factor (Q*) definition, 64 PCNB, 53 derivation of, 63-64, 182, 186 Peanuts for EPA-designated oncogenic active ingredients, 55 number of active ingredients with and without, 56 quantification of, 54-55 uncertainty in, 64, 19~195 variables in, 3, 49-50 Oncogens, definition, 30 Orthene, see Acephate Oryzalin crop uses, 53, 68, 76 dietary oncogenic risk from, 68, 76, 84 Q* for, 55, 76 TMRC, 76 volume of use, 47, 53 weight-of-the-evidence classification, 67, 76 year of first tolerance, 53, 68 Oxadiazon crop uses, 53, 68, 76 dietary oncogenic risk from, 68, 76, 83, 84 Q* for, 55, 76 TMRC, 76 volume of use, 53 weight-of-the-evidence classification, 67, 76 year of first tolerance, 53, 68 p dietary oncogenic risk from, 98 herbicide market share, 98 major crop uses, 53 possible date for tolerance revocation, 98 potential short-term impact of Delaney Clause on, 98 volume of use, 47, 53 year of first tolerance, 53 Parathion crop uses, 53, 68, 77 dietary oncogenic risk from, 68, 77, 84 market life, 137 Q* for, 55, 77 risk reduced through tolerance revocations, 121 volume of use, 53 weight-of-the-evidence classification, 67, 77 vear of first tolerance, 53, 68 dietary oncogenic risk from pesticide residues, 133 effect of policy scenarios on, 105, 107, 110-111, 114, 116-117, 128-129 pesticide use levels on, 48, 52-53 risk reduced by tolerance revocations, 122 Permethrin application of Delaney Clause to, 88, 90,
268 INDEX 92-93, 218-220 application rates, 47, 53 crop uses, 53, 68, 77, 92-93 dietary oncogenic risk from, 68, 74, 76, 77, 83, 84, 85, 88, 217-218 Q* for, 55, 77 risk estimate approaches for, 66 risk reduced through tolerance revocations, 121 weight-of-the-evidence classification, 67, 77 year of first tolerance, 53, 68 Pest resistance to bacterial insecticides, 239-240 Delaney Clause and, 10-11 effect of pesticide use patterns on, 49 to fungal insecticides, 246 to fungicides, 10, 130, 198 management of, 10-11, 157-158 to non-oncogenic pesticides, 10-11, 130 to synthetic pyrethroids, 144 to viral insecticides, 243 Pesticide active ingredients Acceptable Daily Intake of, 31-32 analyzed in this study 4 availability, 20 ,, contact with nontarget crops and organisms, 17-18 degradation products of, 29, 31, 37 dietary exposure to, 32, 59; see also Dietary exposure to pesticides expenditures on, 49, 184 exposure to, see Dietary exposure to pesticides field trials for, 29 historical perspective on R&D on, 141-145 impurities, 31, 37, 88, 90 legal basis for regulation of, 11-12 levels in foods, 61 metabolites, 29, 31, 37, 41, 42, 54, 88, 90, 93-94 patent life, 139 prior-sanctioned, 91-92 registration under FIFRA, 23-24, see Registration of pesticides; Reregistration process with retracted or unpursued tolerance applications, 90 suspected oncogens, EPA policy on, Pesticide use 50-51 - synthetic chemical, 9 toxicological data on, 182 use cancellations, 56 see also Crop-level scenario analyses; Fungicides; Herbicides; Insecticides; specific active ingredients Pesticide active ingredients, new application of Delaney Clause to, 2, 36, 41, 86-96 prospects for, 146-150 recommended safety criteria for, 11-12 simultaneously used with old pesticides, 10 Pesticide active ingredients, non-oncogenic innovations in, 8-9, 125, 128-129, 131, 137, 148-149 tolerance setting under section 408, 31-33 tolerance setting under section 409, 35 Pesticide active ingredients, old (registered before 1978) application of Delaney Clause to, 2, 35, 41, 95-96 benefits of, 7-8, 43 dietary oncogenic risk from, 11, 85 EPA application of Delaney Clause to, 95-96 oncogenicity data on, 41, 51 recommended safety criteria for, 11-12 simultaneously used with new pesticides, 10 Pesticide active ingredients, oncogenic affected by policy scenarios, 106-107, 109-111, 113-114, 116 in animal feeds, 71-74 dichotomous risk standards of sections 408 and 409, 40, 161-170 estimated dietary risk by, 75-77, 83~4 highest risks ever calculated for, 65 low-risk, 7 projections of, 36 Q* for, 55 registered for processed foods, 4-5 with section 409 tolerances, 4-5, 36, 63 substitutes for, 43, 105-106, 149, 200-201, 205 theoretical policy scenarios for regulating, see Scenarios for regulating oncogenic pesticides TMRCs, 60 Waxman list, 50-51 weak, 10, 13-14, 42-43, 95 benefits associated with, 14, 32-33, 43, 103, 123 cancellation/suspension of, 24, 51, 56; see also Tolerance revocation/denial
INDEX 269 data on, 184 factors affecting, 48-49 label specifications for, 24, 93 patterns in U.S., 46-49 regional variation in, 17, 61 Pest management programs, integrated, 153-155, 231 Plant breeding, innovation prospects in, 9, 150-151 Policy recommendations analytical framework, 15-16 coordination between EPA and FDA, 11-12 high-risk pesticide/crop uses, 14-15 negligible-risk standard, 12-14 Potatoes consumption estimates, 57-59 effect of policy scenarios on, 105, 107, 111, 114, 115-116, 126-127 estimated oncogenic risk from, 78~0, 83, 84, 134 pesticide use levels on, 48, 52 risk reduced by tolerance revocations, 122 vulnerability to tolerance revocations, 10 Pounce, see Permethrin Processed commodities, see Commodities, processed Pronamide crop uses, 53, 68, 76 dietary oncogenic risk from, 68, 76, 98 herbicide market share, 98 possible date for tolerance revocation, 98 potential short-term impact of Delaney Clause on, 98 Q* for, 55, 76 TMRC, 76 volume of use, 53 weight-of-the-evidence classification, 67, 76 year of first tolerance, 53, 68 Pseudomonas syringae, 154 Q Q*, see Oncogenicity potency (Q*) Quantitative risk assessment conservatisms in, 50, 54, 60 constituents policy on, 39, 88, 90, 94, 207-208 EPA's current methodology, 3, 33-34, 50, 59-60 limitations of, 33-34 qualitative factors in, 3 risk/benefit balancing, 18, 19, 24, 25, 32-35, 42-43, 226-227 sensitivity-of-the-method approach, 38, 40, 73, 88, 90, 93-94, 120, 223-224 uncertainties in, 33-34, 51, 54 weight-of-the-evidence approach, 3, 54-55,66,101 see also EPA policy, current dietary oncogenic risk estimation R Registration of pesticides burden on registrant after, 24 cancellation/suspension, 24, 51, 56 data required to support, 20, 24, 36, 51 label specifications, 24, 93 minor-use, 156 relation to tolerance-setting process, 23 standards for, under FIFRA, 24 Registration standard, 97 Reregistration process application of Delaney Clause in, 2, 12 Data Call-In Program, 36-37, 96-97 residue chemistry data supporting, 20 Research and development in pest control in chemical pest control, prospects for, 145-148 effect of Delaney Clause implementation on, 9-10, 137, 140, 249-255 expenditures on pesticides, 129, 139-141, 149-150 historical perspective of, 141-145 in nonchemical pest control, 9, 150-155 studies of regulatory effects on, 139-140, 249-255 see also Innovations in pest control Residue chemistry data gathering and interpretation of, 29, 36-37 required to support registration, 20, 24, 36, 51 required to support tolerance petitions, 27-29 Ridomyl, see Metalaxyl Risk definition, 65 see also Dietary oncogenic risk; Dietary oncogenic risk estimation; Quantitative risk assessment Ronilan, see Vinclozolin Ronstar, see Oxadiazon Roundup, see Glyphosate
270 INDEX S Scenarios for regulating oncogenic pesticides analytical methods, 102-103, 187-190 criteria for, 104 crop-level analyses, 7, 102-103, 117, 123-129, 190 crop-pesticide combinations used for, 102 crops losing tolerances under, 106, 109-110, 113-116 cropwide tolerance reduction, 131-134 impacts analyzed in, 101-102 impacts by pesticide type, 118-120 impacts on benefits and risks, 123-129 impacts on individual active ingredient risk, 120-123 negligible-risk, processed foods (scenario 4), 6, 7, 103-104, 114-117 negligible-risk, raw and processed foods (scenario 3), 6, 7, 104, 110-114 zero-risk, processed foods (scenario 2), 6-7, 104, 107-110 zero-risk, raw and processed foods (scenario 1), 6, 103-107 Sodium arsenate, 53 Sodium arsenite, 53, 56 Sonalan, see Ethalfluralin Soybeans effect of policy scenarios on, 107, 111, 114, 116-117, 124 estimated oncogenic risk from, 15, 78, 79 pesticide use levels on, 52-53, 89 risk reduced by tolerance revocations, 122 tolerances for processed forms, 64, 219-220 Sulfonylureas, 144 Sulfur, effectiveness as potato fungicide, 127 Surflan, see Oryzalin Terbutryn T crop uses, 53, 68, 76 dietary oncogenic risk from, 68, 76, 84, 98 herbicide market share, 98 possible date for tolerance revocation, 98 potential short-term impact of Delaney Clause on, 98 Q* for, 55, 76 TMRC, 76 volume of use, 53 weight-of-the-evidence classification, 67, 76 year of first tolerance, 53, 68 Tetrachlorvinphos, 53 Theoretical Maximum Residue Contribution (TMRC) calculation of, 32, 181-182 conservatisms in, 60 distribution of, by pesticide type, 60 reduction of, 33 Thiodicarb application of Delaney Clause to, 88, 90, 93-94, 222-224 degradation to methomyl, 222 dietary oncogenic risk from, 88, 93-94, 221-222 major crop uses, 53 metabolite, 222-223 volume of use, 53 year of first tolerance, 53 Thiophanate-methyl, 53 Tobacco mosaic virus, 152 Tolerance Assessment System (TAS) conversion factors for concentration of residues, 62 data base, 59, 174-175 limitations and improvements in, 57-59, 175 number of processed foods in, 64 treatment of residues in processed foods, 61-63 use in this study, 51 Tolerance revocation/denial dietary oncogenic risk increased by, 8, 14-15, 41-42, 126, 127, 128, 131-134 EPA policy, 34 under policy scenarios, 105-117 possible dates for, on selected fungicides and herbicides, 97-98 regional impacts, 125-126, 128 vulnerability of minor crops to, 10 Tolerance setting actions for which Delaney Clause was cited, 88 benefit consideration in, 18, 19, 24, 25, 32-35 dichotomy in statutory standards for, 2, 11, 40-41, 161-170 EPA policy for, 2, 27-36, 41, 196-224 EPA responsibility for, 18-19
INDEX 27 1 under FDC Act, 19, 2~36 for new active ingredients, case studies of, 91-95 for non-oncogenic pesticides, 31-33 for old active ingredients, case studies of, 95-96 for oncogenic pesticides under section 408, 33-35 process, 27-36 relationship to registration process, 23-24 on suspect oncogens, 51 zero-risk vs. negligible-risk, 2, 6-7, 12-14 Tolerances affected by negligible-risk scenario 3, 112-114 affected by negligible-risk scenario 4 115-116 affected by zero-risk scenario 1, 106-107 affected by zero-risk scenario 2, 109-111 conversion into dietary intake estimate, 59 cropwide reduction of, 131-134 data sources on, 178-179 data required to support requests for, 27-29 definition, 18, 23 dietary oncogenic risk by type of, 67-71, 85-86 fees for, 90, 156 incentives for lowering, 220 influence of Delaney Clause on content of, 90 level-of-detection, 131 levels, 29 minor-use, 155 notice and comment in Federal Register, 27 number in CFR by pesticide type, 19, 35 oncogenic risk associated with date of, 85~6 opposition to, 29 petitions for, 27 processed by-products needing, 72 regulatory status data, 182-183 risk by date of, 85-87 Tolerances, processed commodity (section 409) basis for determining need for, 28 number, 19, 64 for oncogenic pesticides, =5, 36, 63, 69 risk from, 67-71 standard for, 1, 25-27, 35-36 Tolerances, raw commodity (section 408) basis for, 28 benefits considered in determining, 32-33 for oncogenic pesticides, 36, 69 risk from, 67-71 standard for, 1, 25 Tomatoes concentration of residues during processing of, 81-82, 218-219 consumption estimates, 57-59 effect of policy scenarios on, 107, 111, 11~116, 127-128 estimated oncogenic risk from, 78~3, 85, 134 pesticide use levels on, 48, 52 risk reduced by tolerance revocations, 122 tolerance limited to raw form, 88, 90 tolerances for processed forms, 64, 81 vulnerability to tolerance revocations, 10 Toxaphene, 53, 56 Toxicity data/studies no observable effect level, 31-32 required for tolerance petitions, 29 safety factor in, 32 Treflan, see Trifluralin Trifluralin estimated dietary oncogenic risk from, 98 herbicide market share, 98 major crop uses, 53 possible date for tolerance revocation, 98 potential short-term impact of Delaney Clause on, 98 volume of use, 47, 53 year of first tolerance, 53 U U.S. Department of Agriculture food consumption surveys, 57 InterRegional Project 4, 156-157 V Vegetables consumption estimates, 57-58 dependency on pesticides, 49 importance of fungicides in production of, 8 pesticide use levels on, 48, 52-53, 89
272 INDEX regional variation in pesticide use on, 17 Vinclozolin, 90 W Waxman list, 50-51 Zineb z crop uses, 53, 68, 77 dietary oncogenic risk from, 68, 77, 85, 97, 132 fungicide market share, 97, 132 possible date for tolerance revocation, 97, 132 potential short-term impact of Delaney Clause on, 97, 132 Q* for, 55, 77 TMRC, 77 volume of use, 53 weight-of-the-evidence classification, 67, 77 year of first tolerance, 53, 68
