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Pages 257-272

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From page 257...
... 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
From page 258...
... 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,
From page 259...
... 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*
From page 260...
... 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*
From page 261...
... 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
From page 262...
... 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
From page 263...
... 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)
From page 264...
... 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
From page 265...
... 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
From page 266...
... 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*
From page 267...
... 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,
From page 268...
... 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
From page 269...
... ) 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
From page 270...
... , 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)
From page 271...
... 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.
From page 272...
... 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


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