Report from the Sub-comittee on the environment and health

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• Toxic effect on terrestrial organisms: acute toxicity in worms, effect on soil respiration, effect on ammonification, effect on nitrification, effect on asymbiotic N-fixation and, in some cases, effect on symbiotic N-fixation. • Toxic effect on birds: toxicity caused by food intake in species with different food resources (2 species), reproduction test (1 species). The following toxicological data for assessment of effects on humans must be provided for <strong>the</strong> active ingredient: 1) Acute toxicity Toxicity with a single dose of <strong>the</strong> substance. Measured as LD50 (<strong>the</strong> dose needed for half <strong>the</strong> animals to die). Must be tested in separate tests with swallowing, skin contact and inhalation. 2) Local irritation Skin irritation, eye irritation and allergenic properties in connection with skin contact must also be investigated. 3) <strong>Sub</strong>-chronic toxicity Toxicity with daily dosing for 3-6 months. Two tests are required: one on rats (of 3 months duration ) and one on non-rodents (e.g. dogs) of 3-6 months duration. 4) Chronic toxicity Toxicity with long-term dosing. Chronic toxicity and carcinogenicity are often combined in <strong>the</strong> same 2-year test. Two tests are required on different species of mammal. If dogs are more sensitive than rats, a separate 1-year toxicity test on dogs is required. 5) Carcinogenic effect 6) Mutagenicity The ability of <strong>the</strong> substance to cause damage to <strong>the</strong> genetic material. Must be tested in test-tube tests (in vitro) and in animal tests (in vivo). If <strong>the</strong> substance is found to be positive in <strong>the</strong> above tests, it must be tested in gametes. 7) Tests on impairment of fertility Multi-generational tests; <strong>the</strong> possible ability of <strong>the</strong> substance to reduce fertility must be tested by feeding with <strong>the</strong> substance through several generations. 8) Teratogenicity tests The ability of <strong>the</strong> substance to damage <strong>the</strong> foetus during pregnancy must be tested in two species of mammal. The pregnant dam must receive <strong>the</strong> substance by tube in <strong>the</strong> most sensitive period of <strong>the</strong> pregnancy. 9) Neurotoxicity Particularly for <strong>the</strong> so-called cholinesterase inhibitors. 10) Toxicity of any metabolites, degradation products and impurities. 249
250 11) Metabolism in animals The substance’s absorption, distribution, degradation and elimination. 12) Toxicity to humans Experience gained during, for example, production. The following toxicological data are required for <strong>the</strong> product: 1. Acute oral toxicity 2. Acute toxicity through <strong>the</strong> skin 3. Acute toxicity when inhaled 4. Skin irritation 5. Eye irritation 6. O<strong>the</strong>r toxicological data for <strong>the</strong> product 7. Toxicological data for non-active ingredients. The above data have normally been obtained by means of laboratory tests. In cases in which <strong>the</strong> laboratory tests indicate that <strong>the</strong> substance is problematical, supplementary laboratory tests or tests under semi-field or field conditions have in some cases been carried out. Typically, field tests have been carried out concerning degradation of <strong>the</strong> active ingredient, semi-field tests concerning mobility (lysimeter tests) or mesocosm tests concerning toxicity in aquatic organisms. The quality of <strong>the</strong> tests and <strong>the</strong> relevance of <strong>the</strong> data to Danish conditions are evaluated before <strong>the</strong> data are used in <strong>the</strong> risk assessment.
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The Bichel Committee 1999 R
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1 INTRODUCTION 7 2 THE SUB-COMMITTE
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9 ENVIRONMENTAL AND HEALTH ASSESSME
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1 Introduction On 15 May 1997 <stro
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The President Members 10 Henrik San
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Consultants’ reports 12 The sub-c
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14 4 Occurrence of pesticides in <s
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The Nationwide Monitoring Programme
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Counties analyse samples fr
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20 system. However, the</st
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941 110 22 MB 270 31 13 MB 1281 10
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Substance Permitte
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26 The distribution of finds of pes
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28 concentrations of up to 11 micro
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Table 4.10 Occurrence of pesticides
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32 It will be seen from</st
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34 • The frequency of detection i
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36 Soil water samples containing pe
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38 Bromoxynil 3 n.d. 0.04 54 DNOC 4
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40 concentrations found so far are
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42 mononitrophenols and oth
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44 The main measure used to try to
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Models for volatilisation 46 • It
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Calculation of the
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Processes that remove pesticides <s
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52 atrazine and the</strong
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Potential sources of pesticides in
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56 Example 1: IPU dosage 1000 g act
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58 completely against future pollut
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Exposure of field fauna through tre
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Leaf beetles Direct effects of spra
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Indirect effects on mammals and bir
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Birds are particularly interesting
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Importance of headland vegetation t
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Effects of pesticides in forestry A
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Repeated spraying changes t
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Effect on seed production The wild
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Impact on the flor
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• The sub-committee recommends mo
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Effects on primary producers The ef
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Effects on amphibians Unlawful use
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concentrations than the</st
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The sub-committee recommends more c
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General ergonomic problems Particul
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Tractor accidents Accidents resulti
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The sprayer operator’s exposure t
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Pesticides and cancer 96 th
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Studies of frequency of cancer Repr
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Neurotoxicity Immunotoxicity and se
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Population studies 102 • Long-ter
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Other risk groups
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106 tomat salat kinakål kartofler
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Calculation of pesticide intake <st
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The Danes’ dietary pattern Reduct
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Estimated intake from</stro
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Table 6.4 Estimated pesticide intak
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Variation in daily intake of pestic
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Endosulfan = Endosulfan Methidathio
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Limit values Authorisation of pesti
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Analytical studies: case control st
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Cancer Mechanism behind the
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Neurotoxicity Neurotoxicity in chil
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128 6.2.7 Conclusions There is insu
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130 • It cannot be proven on <str
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132 Danish products. There are big
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134
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Definition of proportionality Heavy
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Tropospheric ozone Veterinary drugs
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140 effect that can be expected per
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Synthetic pesticid
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144 formulations. Therefore, <stron
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International cooperation 146 be il
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Fuzzy Expert model Expert assessmen
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Setting up a gross list with a view
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Better monitoring of the</s
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154 help in the as
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Impact index for the</stron
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Knowledge-building in the</
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160 In relation to the</str
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Uncertainties and variations 162 A
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164 which is fixed at 0.1 microgram
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166 If the risk as
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Prevention of disease in cereal cro
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Prevention of pest attack in agricu
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172 plants whose ability to establi
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Biobeds Municipal environmental sup
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Malt barley and gushing Direct effe
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Effect of soil treatment on wild pl
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Emissions of greenhouse gases 180 p
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Conclusions concerning environmenta
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Conclusions concerning leaching of
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0+-scenario: almost total phase-out
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Scenarios for forests Weath
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Soil Residues in the</stron
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Impact on the fiel
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Earthworms 194 has been carried out
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Assumptions and uncertainties Resul
Page 199 and 200: Comparison of weed control with and
Page 201 and 202: Results of calculations with <stron
Page 203 and 204: 202 Scenarier Ingen behandling Plus
Page 205 and 206: Impacts on the flo
Page 207 and 208: Results of the mod
Page 209 and 210: Mechanical weed control 208 Behandl
Page 211 and 212: The Dane's dietary pattern and dail
Page 213 and 214: 212 11 The sub-committee’s summar
Page 215 and 216: Conclusion concerning lack of time
Page 217 and 218: Conclusion concerning impacts on fl
Page 219 and 220: Conclusions concerning model analys
Page 221 and 222: Conclusions concerning exposure to
Page 223 and 224: Conclusion concerning mycotoxins Th
Page 225 and 226: Ranking with respect to groundwater
Page 227 and 228: Conclusion concerning emissions of
Page 229 and 230: Conclusions concerning natural subs
Page 231 and 232: 230 12 References Abell, A., Bonde,
Page 233 and 234: 232 Colborn, T., vom Saal., F.S., S
Page 235 and 236: 234 Eyer, P. (1995). Neuropsychopat
Page 237 and 238: 236 Graae, B.J. (1999). Florest flo
Page 239 and 240: 238 Protection Conference: Pesticid
Page 241 and 242: 240 Lindhardt, B., Sørensen, P.B.,
Page 243 and 244: 242 consumption of fossil energy wi
Page 245 and 246: 244 intoxication. The Pesticide Hea
Page 247 and 248: 246 Underudvalget for Miljø og Sun
Page 249: 248 Annex 1 Data required for autho
Page 253 and 254: 252 Annex 2 The general rules for r
Page 255 and 256: Category 1 Category 2 Category 3 25
Page 257: 256 reasonable and usable system fo
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