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

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Table H4.4Level of riskMagnitude of effectLikelihood Minimal Minor Moderate Major MassiveHighly improbable A A A B BVery unlikely A A B B CUnlikely A B B C CLikely B B C C DHighly likely B C C D DDichlorvos reassessment – application Page 384 of 436
Appendix I: Data from which classifications derived by mixturerules were derivedComposition of dichlorvos formulationsName/CodeMaximum Concentration(% w/w)Emulsifiableconcentratecontaining1000 g/litredichlorvosEmulsifiableconcentratecontaining1140 g/litredichlorvosAerosolcontaining 50g/kgdichlorvosFlammableaerosolcontaining 3.1g/litredichlorvosand 8.7 g/litrepropoxurReady to useliquidcontaining 4.4g/litredichlorvosand 9.6 g/litrepropoxurDDVPInsecticideStripJ72.03Dichlorvos 70.7 82.6 5 0.45 0.45 22 24Propoxur 1.3 1A 15B 6.9 14C 0.14D 95 95E 47F 24G 19H 8.2I 79J 8.4K 7L 18M 5.1N 1 +N 2 0.059N 3 0.44N 4 0.0076N 5 0.0038N 6 0.036N 7 0.0065N 8 0.041N 9 0.1N 10 4.7N 11 0.0049O 0.07P +Q 52Dichlorvos reassessment – application Page 385 of 436
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Application for the Reassessment of
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6.1 Evaluation of options to streng
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EXECUTIVE SUMMARYIn briefERMA New Z
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Aerosol containing 50 g/kgdichlorvo
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ERMA New Zealand‘s recommendation
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26 - 29Outdoor public space usage30
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Substance details1-8,11-16,20-25,30
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1.2.3 In 2008, the Environmental Ri
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Table 1. Dichlorvos-containing subs
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public environments and use for bio
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available to it. In preparing this
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3.3 International regulatory positi
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3.6 Classification3.6.1 The HSNO cl
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Hazard Class /SubclassClassificatio
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Hazard Class /SubclassClassificatio
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Rates:Fogging: 13 ml / litre (water
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BV2 SurfaceInsecticideBV2 SurfaceIn
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Table 7.Dichlorvos outdoor and indo
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Scenario Crop/Use Method Rate Appli
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humidity conditions. The higher res
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4.3 EnvironmentIdentification of ad
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4.3.9.3 Aquatic environment - Groun
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is considered to be highly improbab
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RiskGroupRQ range Level of risk Use
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RiskGroupRQ range Level of risk Use
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assessment, as the Use Scenario inc
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Nonnegligible1 < RQ < 10Nonnegligib
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Table 12.LifecycleStageImport,manuf
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LifecycleStageUse -bystanderUseScen
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Table 13.Identification of benefici
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value that can be attributed to dic
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outbreak, MAF‘s ability to demons
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the duty of the Crown is not merely
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5.1.7.1 J. Hicking stated that dich
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Table 14. Comparative of hazard cla
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Crop Pest Active ingredient Preharv
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Crop Pest Active ingredient Preharv
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SECTION 6- PROPOSALS TO MANAGE RISK
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Assessment was carried out with spe
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6.1.11 Controls to protect bystande
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Table 16Effect of additional contro
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Use Scenario Receptor Level of Risk
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have, and notes the following as ar
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Table 18Summary of benefits associa
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UseScenariosAssessment ofEffectOutc
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Substance detailsHSR000126DDVPInsec
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Table 22.there are no practicable r
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7.4 Preliminary Recommendations7.4.
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method and LOQ)Water (principle ofm
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Appendix B: Environmental Fate of d
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Bioconcentration factor Gnathopogon
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Table C.2:Scenarios used in exposur
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Scenario 3: Vegetables - 1 applicat
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FIELD AND STANDARD POND HALFLIFE VA
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insectivorous bird7 Passionfruit Sm
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4 Leafyvegetables(BBCH ≥50)4 Leaf
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summer)7 passionfruit(BBCH 10-19)7
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Ground (lowboom)0.03 0.03 1.07 1.07
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Appendix D: Ecotoxicity of dichlorv
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ioaccumulationClearance timeLevel o
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Table D.5:Toxicity to terrestrial i
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Appendix E: Risk Assessment: Enviro
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Aquatic organsimsTable E.3:Environm
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12345Crop type Table I.1 (Annex 1)
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7 passionfruit(BBCH 20-39)7 passion
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Fruit (tree) 2052 70759 >50Passionf
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Appendix F: Human Toxicity of dichl
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CONTENTS:Title Page 11 Purpose 2Con
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2 SUBSTANCE IDENTIFICATIONIUPAC nam
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However, dichlorvos has genotoxic p
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4 ABSORPTION, DISTRIBUTION, METABOL
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aerosol cans (230-330 g dichlorvos)
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4.3 Metabolism:found in tissues of
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dose of 1.0 mg/kg bw, a single gava
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eports. LD 50 = 46.4 mg/kg b.w. is
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6 ACUTE DERMAL 6.1HSNO Classificati
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7 ACUTE INHALATION 6.1HSNO Classifi
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measured and it was not possible to
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8 SKIN IRRITATION 6.3 & CORROSION 8
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9 EYE IRRITATION 6.4 & CORROSION 8.
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10 RESPIRATORY SENSITISATION 6.5AHS
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Justification for Classification: U
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12 MUTAGENICITY 6.6HSNO Classificat
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ERMA New Zealand CONFIDENTIAL Repor
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The ATSDR (1997) reported:“Dichlo
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•ATSDR (1997): http://www.atsdr.c
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13 CARCINOGENICITY 6.7HSNO Classifi
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fibroadenomas were observed in 6 (1
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• Sex/Numbers:• Test material:
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The NTP Peer Review concluded that:
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concurrent studies for comparison w
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The APVMA (2008a) reported a chroni
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was exposed. The estimated daily in
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14 REPRODUCTIVE TOXICITY 6.8HSNO Cl
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ppm during premating days, signific
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Toxicology, Chemistry and Life Scie
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addition, there was an increase in
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• Maternal toxicity NOAEL =• Ma
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Research Triangle Park, North Carol
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16 REPRODUCTIVE OR DEVELOPMENTAL TO
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17 SPECIFIC TARGET ORGAN TOXICITY 6
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There was a significant dose-relate
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KEY STUDY:• Type of study:• Spe
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BACKGROUND:The APVMA (2008a) also r
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cholinesterases can only be estimat
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Ltd, Sittingbourne Research Center,
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23 OTHER POTENTIAL TOXIC ENDPOINTS2
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―Results“Mortalities and clinic
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1984). QA study. Study conducted ac
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“No information was located on im
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“Comment: These incidents clearly
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25 ACCEPTABLE OPERATOR EXPOSURE LEV
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to pretreatment activity). When the
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cholinesterase inhibition in health
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protect agricultural workers who ha
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Wash: refers to skin washes; Dressi
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Hazard Class/SubclassHazardclassifi
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Hazard Class/SubclassHazardclassifi
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REFERENCES:APVMA, 2008a. ―DICHLOR
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Appendix 1:APVMA - Summary of bench
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“Inhalational NOEL for Occupation
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activity). In fact, treatment was s
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LAST PAGEDichlorvos reassessment -
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Dichlorvos:Occupational, Bystander,
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CONTENTS:Title Page 11 Purpose 2Con
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3ACTIVITY SCENARIOS3.1 Table (I) su
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access of bystanders to treated are
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can reduce dermal exposures to mixe
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contaminated with, respectively 0.0
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The modelling is based upon dischar
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Table II: Occupational Exposure Est
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Table III: Occupational Exposure Es
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Operation / RPE / PPETable IV: Occu
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1.25L product/ha; work rate, 1.25 h
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Application: Air-hose RPE + chem. r
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Application: Half-face RPE + overal
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P for RPE (% penetration): none, 1
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Table X: Occupational Exposure Esti
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provided: work day exposure is limi
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5POST-APPLICATION OR RE-ENTRY WORKE
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D = DFR x TC x DA x WR x AR x P / B
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Re-entry into out-door crops (Scena
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Re-entry into treated glasshouses d
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acceptable 240 minutes after applic
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Re-entry into treated glasshouses u
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Table XVII: Re-entry into glasshous
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lowest use rate (52 mg/m 3 ; 1300g
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DA = percentage dermal absorption [
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Re-entry into treated enclosed indu
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nature of the building itself, not
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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: 1.3. The likelihood applies to the
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
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Appendix O: ReferencesACVM (2010) h
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