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

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Appendix 5Re-entry Worker Exposure Estimate and Risk Assessment – Out-door Crops(Example calculations for Table XII)Scenarios 1 & 2, 3c & 4c: Berries (0.8kg/ha with 1 or 2 applications per year)Re-entry by a worker for picking: dermal exposure.Assuming an application of 800g dichlorvos/ha.A working day of 8 hours is assumed.For the transfer of residues from foliage to the clothes or skin of a worker, a TC value of3000 cm 2 /hr is used (UK CRD, 2008a).A DFR value of 0.5 μg/cm 2 per kg a.s./ha applied is used (based on Casida et al., 1962in APVMA, 2008b) (See paragraphs 5.9 & 5.10).Predicted exposure for this scenario is thusD = DFR x TC x DA x WR x AR x P / BWWhere:D = Dermal Exposure [μg a.s./person*d]DFR = Dislodgeable Foliar Residue per kg a.s./ha = 0.5 μg a.s./cm² per kga.s./haTC = Transfer Coefficient [cm²/person/h] = 3000 [cm²/person/h]DA = percentage dermal absorption (30%), expressed as a fractionWR = Work Rate [8 hours/day]AR = Application Rate [0.8 kg a.s./ha]P = Penetration Factor for Clothing [= 1] which assumes one layer of ordinaryclothing is taken into accountBW = bodyweight (70 kg)Dermal Exposure (D) is 41 μg a.s./kg b.w./day.D = 0.5 x 3000 x 0.3 x 8 x 0.8 x 1 = 2880 / 7070With PPE:The German BBA Model for re-entry tasks assumes a Penetration Factor (P) for PPE as0.05 (i.e. 95% protection, given by hood/visor + overalls over long-sleeved shirt andlong-legged trousers + boots + gloves).Applying these figures to the Penetration Factor for Clothing (P) in the above equationgives the previous D x 0.05.Dichlorvos reassessment – application Page 366 of 436
The Dermal Exposure (D) is 2.06 μg a.s./kg b.w./day.Re-entry by a worker for picking: inhalation exposure.Using the data from Casida et al. (1962), 20 minutes after application to the leafsurfaces of maize, cotton and peas about 50% was volatilised, while 5% remains on theleaf surfaces and 45% absorbed by the plant (in APVMA, 2008b).It is assumed therefore that only 50% of the application rate is available for possibleinhalation:Inhalation Exposure (I) = mg a.s./hr inhaled x WR / BWmg a.s./hr inhaled = kg/a.s./ha applied x Task Specific FactorWhere:indicative Task Specific Factor = 0.01 (See paragraph 5.20);WR = Work Rate (8 hours/day)AR = Application Rate (50% of 0.8 kg a.s./ha)BW = bodyweight (70 kg)I = ((0.5 x 0.8 x 0.01) x 8) / 70 = 0.032 / 70 = 0.00046 mg/kg b.w./dayInhalation Exposure (I) is 0.00046 mg a.s./kg b.w./day or 0.46 μg a.s./kg b.w./day.With RPE:The APVMA (2008b) use the following protective factors for various RPE:Half-face respirator 0.1Full-face 0.02Air-hosenil inhalation exposureWith a half-face respirator: I = 0.46 x 0.1 = 0.046 μg a.s./kg b.w./day;full-face:I = 0.46 x 0.02 = 0.0092 μg a.s./kg b.w./day;Dichlorvos reassessment – application Page 367 of 436
Page 1 and 2:
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
Page 315 and 316: Re-entry into treated glasshouses d
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Page 319 and 320: Re-entry into treated glasshouses u
Page 321 and 322: Table XVII: Re-entry into glasshous
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Page 325 and 326: DA = percentage dermal absorption [
Page 327 and 328: Re-entry into treated enclosed indu
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Page 331 and 332: Conclusions on re-entry worker expo
Page 333 and 334: 6BYSTANDER & RESIDENT EXPOSURE & RI
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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: With overalls and gloves (protectio
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
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Current usesFormulations:Methods of
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CanadaStatusPMRA are undertaking a
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Appendix L: Parties consulted durin
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Animal Products Act 19995. The purp
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14. Regulatory control of these pro
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Zealand‘s trade in primary produc
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processed and stored. It employs ve
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may be taken to risk management in
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Appendix A• Agricultural Compound
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Appendix O: ReferencesACVM (2010) h
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