Application for the Reassessment of a Hazardous Substance under ...

More documents

Recommendations

Info

Use Scenario Receptor Level of Risk (with existingcontrols in place)Operator exposure(restricted entry)Non-negligible(> AOEL)Proposed Additional Contol- half-face respirator with minimum specificationof A1P2.Application rate should be restricted to 0.05 g a.i. / m 3 ,in order for an REI to be set.Introduce REIs:- entry into treated glasshouse areas for anypurpose is prohibited for 4 hours after completionof application; and- restricted entry into treated glasshouse areas ispermitted after 4 hours has elapsed sincecompletion of application for ventilation tasksonly; and- restricted entry into treated glasshouse areas ispermitted after at least 4 hours has elapsed sincecommencement of ventilation for tending tasks;- restricted entry into treated glasshouse areas ispermitted after at least 72 hours has elapsed sincecommencement of ventilation for harvesting orother tasks that involve contact with treatedcrops.Introduce PPE/RPE requirements for entry into treatedglasshouse areas for ventilation tasks:PPE:- hood/visor,- overalls over long-sleeved shirt and long-leggedtrousers;Modified Level ofRiskNegligible.Dichlorvos reassessment – application Page 90 of 436
Use Scenario Receptor Level of Risk (with existingcontrols in place)Proposed Additional Contol- boots;- gloves.RPE:- full-face with minimum specification of A1P2, orair-hose respirator.Introduce PPE/RPE requirements for post-ventilationentry into treated glasshouse areas:PPE:- hat and goggles,- overalls over long-sleeved shirt and long-leggedtrousers;- boots;- gloves.Introduce a maximum exposure time persons enteringtreated areas:- for ventilation tasks, < 30 minute / day;- for tending / harvesting tasks, < 1 hours / dayuntil at least 72 hours has elapsed sincecompletion of application.Modified Level ofRisk15, 16 Operator exposure(mixing, loading,application)Non-negligible (> AOEL)No practical options available to reduce risks to operatorsduring mixing, loading or application.Non-negligible.Operator exposure Non-negligible (> AOEL) No REI can be set for these Use Scenarios, based on an Non-negligible.Dichlorvos reassessment – application Page 91 of 436
Page 1 and 2:
Application for the Reassessment of
Page 3 and 4:
6.1 Evaluation of options to streng
Page 5 and 6:
EXECUTIVE SUMMARYIn briefERMA New Z
Page 7 and 8:
Aerosol containing 50 g/kgdichlorvo
Page 9 and 10:
ERMA New Zealand‘s recommendation
Page 11 and 12:
26 - 29Outdoor public space usage30
Page 13 and 14:
Substance details1-8,11-16,20-25,30
Page 15 and 16:
1.2.3 In 2008, the Environmental Ri
Page 17 and 18:
Table 1. Dichlorvos-containing subs
Page 19 and 20:
public environments and use for bio
Page 21 and 22:
available to it. In preparing this
Page 23 and 24:
3.3 International regulatory positi
Page 25 and 26:
3.6 Classification3.6.1 The HSNO cl
Page 27 and 28:
Hazard Class /SubclassClassificatio
Page 29 and 30:
Hazard Class /SubclassClassificatio
Page 31 and 32:
Rates:Fogging: 13 ml / litre (water
Page 33 and 34:
BV2 SurfaceInsecticideBV2 SurfaceIn
Page 35 and 36:
Table 7.Dichlorvos outdoor and indo
Page 37 and 38:
Scenario Crop/Use Method Rate Appli
Page 39 and 40: humidity conditions. The higher res
Page 41 and 42: 4.3 EnvironmentIdentification of ad
Page 43 and 44: 4.3.9.3 Aquatic environment - Groun
Page 45 and 46: is considered to be highly improbab
Page 47 and 48: RiskGroupRQ range Level of risk Use
Page 49 and 50: RiskGroupRQ range Level of risk Use
Page 51 and 52: assessment, as the Use Scenario inc
Page 53 and 54: Nonnegligible1 < RQ < 10Nonnegligib
Page 55 and 56: Table 12.LifecycleStageImport,manuf
Page 57 and 58: LifecycleStageUse -bystanderUseScen
Page 59 and 60: Table 13.Identification of benefici
Page 61 and 62: value that can be attributed to dic
Page 63 and 64: outbreak, MAF‘s ability to demons
Page 65 and 66: the duty of the Crown is not merely
Page 67 and 68: 5.1.7.1 J. Hicking stated that dich
Page 70 and 71: Table 14. Comparative of hazard cla
Page 72 and 73: Crop Pest Active ingredient Preharv
Page 74 and 75: Crop Pest Active ingredient Preharv
Page 76 and 77: SECTION 6- PROPOSALS TO MANAGE RISK
Page 78 and 79: Assessment was carried out with spe
Page 80 and 81: 6.1.11 Controls to protect bystande
Page 82 and 83: Table 16Effect of additional contro
Page 84 and 85: Use Scenario Receptor Level of Risk
Page 106 and 107: have, and notes the following as ar
Page 108 and 109: Table 18Summary of benefits associa
Page 110 and 111: UseScenariosAssessment ofEffectOutc
Page 112 and 113: Substance detailsHSR000126DDVPInsec
Page 114 and 115: Table 22.there are no practicable r
Page 116: 7.4 Preliminary Recommendations7.4.
Page 119 and 120: method and LOQ)Water (principle ofm
Page 121 and 122: Appendix B: Environmental Fate of d
Page 123 and 124: Bioconcentration factor Gnathopogon
Page 125 and 126: Table C.2:Scenarios used in exposur
Page 127 and 128: Scenario 3: Vegetables - 1 applicat
Page 129 and 130: FIELD AND STANDARD POND HALFLIFE VA
Page 131 and 132: insectivorous bird7 Passionfruit Sm
Page 133 and 134: 4 Leafyvegetables(BBCH ≥50)4 Leaf
Page 135 and 136: summer)7 passionfruit(BBCH 10-19)7
Page 137 and 138: Ground (lowboom)0.03 0.03 1.07 1.07
Page 139 and 140: Appendix D: Ecotoxicity of dichlorv
Page 141 and 142:
ioaccumulationClearance timeLevel o
Page 143 and 144:
Table D.5:Toxicity to terrestrial i
Page 145 and 146:
Appendix E: Risk Assessment: Enviro
Page 147 and 148:
Aquatic organsimsTable E.3:Environm
Page 149 and 150:
12345Crop type Table I.1 (Annex 1)
Page 151 and 152:
7 passionfruit(BBCH 20-39)7 passion
Page 153 and 154:
Fruit (tree) 2052 70759 >50Passionf
Page 155 and 156:
Appendix F: Human Toxicity of dichl
Page 157 and 158:
CONTENTS:Title Page 11 Purpose 2Con
Page 159 and 160:
2 SUBSTANCE IDENTIFICATIONIUPAC nam
Page 161 and 162:
However, dichlorvos has genotoxic p
Page 163 and 164:
4 ABSORPTION, DISTRIBUTION, METABOL
Page 165 and 166:
aerosol cans (230-330 g dichlorvos)
Page 167 and 168:
4.3 Metabolism:found in tissues of
Page 169 and 170:
dose of 1.0 mg/kg bw, a single gava
Page 171 and 172:
eports. LD 50 = 46.4 mg/kg b.w. is
Page 173 and 174:
6 ACUTE DERMAL 6.1HSNO Classificati
Page 175 and 176:
7 ACUTE INHALATION 6.1HSNO Classifi
Page 177 and 178:
measured and it was not possible to
Page 179 and 180:
8 SKIN IRRITATION 6.3 & CORROSION 8
Page 181 and 182:
9 EYE IRRITATION 6.4 & CORROSION 8.
Page 183 and 184:
10 RESPIRATORY SENSITISATION 6.5AHS
Page 185 and 186:
Justification for Classification: U
Page 187 and 188:
12 MUTAGENICITY 6.6HSNO Classificat
Page 189 and 190:
ERMA New Zealand CONFIDENTIAL Repor
Page 191 and 192:
The ATSDR (1997) reported:“Dichlo
Page 193 and 194:
•ATSDR (1997): http://www.atsdr.c
Page 195 and 196:
13 CARCINOGENICITY 6.7HSNO Classifi
Page 197 and 198:
fibroadenomas were observed in 6 (1
Page 199 and 200:
• Sex/Numbers:• Test material:
Page 201 and 202:
The NTP Peer Review concluded that:
Page 203 and 204:
concurrent studies for comparison w
Page 205 and 206:
The APVMA (2008a) reported a chroni
Page 207 and 208:
was exposed. The estimated daily in
Page 209 and 210:
14 REPRODUCTIVE TOXICITY 6.8HSNO Cl
Page 211 and 212:
ppm during premating days, signific
Page 213 and 214:
Toxicology, Chemistry and Life Scie
Page 215 and 216:
addition, there was an increase in
Page 217 and 218:
• Maternal toxicity NOAEL =• Ma
Page 219 and 220:
Research Triangle Park, North Carol
Page 221 and 222:
16 REPRODUCTIVE OR DEVELOPMENTAL TO
Page 223 and 224:
17 SPECIFIC TARGET ORGAN TOXICITY 6
Page 225 and 226:
There was a significant dose-relate
Page 227 and 228:
Page 229 and 230:
Page 231 and 232:
Page 233 and 234:
KEY STUDY:• Type of study:• Spe
Page 235 and 236:
BACKGROUND:The APVMA (2008a) also r
Page 237 and 238:
cholinesterases can only be estimat
Page 239 and 240:
Page 241 and 242:
Ltd, Sittingbourne Research Center,
Page 243 and 244:
23 OTHER POTENTIAL TOXIC ENDPOINTS2
Page 245 and 246:
―Results“Mortalities and clinic
Page 247 and 248:
1984). QA study. Study conducted ac
Page 249 and 250:
“No information was located on im
Page 251 and 252:
“Comment: These incidents clearly
Page 253 and 254:
25 ACCEPTABLE OPERATOR EXPOSURE LEV
Page 255 and 256:
to pretreatment activity). When the
Page 257 and 258:
cholinesterase inhibition in health
Page 259 and 260:
protect agricultural workers who ha
Page 261 and 262:
Wash: refers to skin washes; Dressi
Page 263 and 264:
Hazard Class/SubclassHazardclassifi
Page 265 and 266:
Hazard Class/SubclassHazardclassifi
Page 267 and 268:
REFERENCES:APVMA, 2008a. ―DICHLOR
Page 269 and 270:
Appendix 1:APVMA - Summary of bench
Page 271 and 272:
“Inhalational NOEL for Occupation
Page 273 and 274:
activity). In fact, treatment was s
Page 275 and 276:
LAST PAGEDichlorvos reassessment -
Page 277 and 278:
Dichlorvos:Occupational, Bystander,
Page 279 and 280:
CONTENTS:Title Page 11 Purpose 2Con
Page 281 and 282:
3ACTIVITY SCENARIOS3.1 Table (I) su
Page 283 and 284:
access of bystanders to treated are
Page 285 and 286:
can reduce dermal exposures to mixe
Page 287 and 288:
contaminated with, respectively 0.0
Page 289 and 290:
The modelling is based upon dischar
Page 291 and 292:
Table II: Occupational Exposure Est
Page 293 and 294:
Table III: Occupational Exposure Es
Page 295 and 296:
Operation / RPE / PPETable IV: Occu
Page 297 and 298:
1.25L product/ha; work rate, 1.25 h
Page 299 and 300:
Application: Air-hose RPE + chem. r
Page 301 and 302:
Application: Half-face RPE + overal
Page 303 and 304:
P for RPE (% penetration): none, 1
Page 305 and 306:
Table X: Occupational Exposure Esti
Page 307 and 308:
provided: work day exposure is limi
Page 309 and 310:
5POST-APPLICATION OR RE-ENTRY WORKE
Page 311 and 312:
D = DFR x TC x DA x WR x AR x P / B
Page 313 and 314:
Re-entry into out-door crops (Scena
Page 315 and 316:
Re-entry into treated glasshouses d
Page 317 and 318:
acceptable 240 minutes after applic
Page 319 and 320:
Re-entry into treated glasshouses u
Page 321 and 322:
Table XVII: Re-entry into glasshous
Page 323 and 324:
lowest use rate (52 mg/m 3 ; 1300g
Page 325 and 326:
DA = percentage dermal absorption [
Page 327 and 328:
Re-entry into treated enclosed indu
Page 329 and 330:
nature of the building itself, not
Page 331 and 332:
Conclusions on re-entry worker expo
Page 333 and 334:
6BYSTANDER & RESIDENT EXPOSURE & RI
Page 335 and 336:
Children’s incidental ingestion o
Page 337 and 338:
Table XX: Spray driftExposure throu
Page 339 and 340:
Exposure through contactwithcontami
Page 341 and 342:
Conclusions on bystander and reside
Page 343 and 344:
Table XXIII: Dichlorvos Use Scenari
Page 345 and 346:
mixing/loading. Mixing/loading fogg
Page 347 and 348:
7.23 Re-entry for ventilation of in
Page 349 and 350:
REFERENCES:APVMA, 2008a. ―DICHLOR
Page 351 and 352:
Appendix 1:Occupational Exposure Es
Page 353 and 354:
FactorExposure (μg/kg a.i. handled
Page 355 and 356:
Inhalation exposure from cylinder c
Page 357 and 358:
[0.01875 x {(0.018 x 0.05) + (2.68
Page 359 and 360:
With half-face respirator (protecti
Page 361 and 362:
With full-body chemical resistant c
Page 363 and 364:
Appendix 4:Occupational Exposure Es
Page 365 and 366:
With overalls and gloves (protectio
Page 367 and 368:
The Dermal Exposure (D) is 2.06 μg
Page 369 and 370:
TTR = turf transferable residues -
Page 371 and 372:
F = fraction of residue retained on
Page 373 and 374:
TTR = transferable residues - the E
Page 375 and 376:
Public Space ApplicationsScenario (
Page 377 and 378:
ERMA New Zealand‟s comment on the
Page 379 and 380:
Enclosed SpaceAgricultural UseOutdo
Page 381 and 382:
Appendix H: Qualitative Descriptors
Page 383 and 384:
1.3. The likelihood applies to the
Page 385 and 386:
Appendix I: Data from which classif
Page 387 and 388:
Endpoint Units * Dichlorvos Propoxu
Page 389 and 390:
Toxicity mixture calculationsSubcla
Page 391 and 392:
Subclass 9.3 -Ecotoxicity to terres
Page 393 and 394:
Table J.1:Existing controls for dic
Page 395 and 396:
TrackingcontrolsIdentification cont
Page 397 and 398:
Table J.2:Summary of default contro
Page 399 and 400:
Hazardous Substances (Classes 1 to
Page 401 and 402:
Hazardous Substances (Classes 6, 8,
Page 403 and 404:
Hazardous Substances (Classes 6, 8,
Page 405 and 406:
(a) means piping that—(i) is conn
Page 407 and 408:
Code I29 Regs 51, 52 Signage requir
Page 409 and 410:
Non-HSNO Act controlsAgricultural C
Page 411 and 412:
Appendix K: Overseas regulatory act
Page 413 and 414:
Product Use Further details ofuseSu
Page 415 and 416:
Risk assessment identified concerns
Page 417 and 418:
Current usesFormulations:Methods of
Page 419 and 420:
CanadaStatusPMRA are undertaking a
Page 421 and 422:
Appendix L: Parties consulted durin
Page 423 and 424:
Animal Products Act 19995. The purp
Page 425 and 426:
14. Regulatory control of these pro
Page 427 and 428:
Zealand‘s trade in primary produc
Page 429 and 430:
processed and stored. It employs ve
Page 431 and 432:
may be taken to risk management in
Page 433 and 434:
Appendix A• Agricultural Compound
Page 435 and 436:
Appendix O: ReferencesACVM (2010) h
show all

Application for the Reassessment of a Hazardous Substance under ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?