|
Items in cart [0] |
Questions? Call 888-624-8373 |
| Copyright © 2009. National Academy of Sciences. All rights reserved. Terms of Use and Privacy Statement |
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 257
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
OCR for page 258
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,
OCR for page 259
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
OCR for page 260
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
OCR for page 261
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
OCR for page 262
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
OCR for page 263
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,
OCR for page 264
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
OCR for 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
OCR for page 266
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,
OCR for page 267
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,
OCR for page 268
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
OCR for page 269
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
OCR for page 270
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
OCR for page 271
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
OCR for 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
Representative terms from entire chapter:
dietary oncogenic
