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

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UK CRD, 2008c. ―OPERATOR EXPOSURE GUIDANCE FOR AMATEUR (HOMEGARDEN) PESTICIDES.‖http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Amateur%20use%20guidance%202.pdfUS EPA, 1997. ―Standard Operating Procedures (SOPs) for Residential ExposureAssessments.‖ Contract No. 68-W6-0030; Work Assignment No. 3385.102 [trac6a05]US EPA, 2000. ―Worker Risk Mitigation for Organophosphate Pesticides.‖ PesticideRegistration (PR) Notice 2000-9 September 29, 2000.US EPA, 2006a. ―Reregistration Eligibility Decision for Dichlorvos (DDVP).‖ Officeof Pesticide Programs, UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY, WASHINGTON D.C., 20460.WHO/IPCS, 1971. ―1970 EVALUATIONS OF SOME PESTICIDE RESIDUES INFOOD.‖ AGP:1970/M/12/1; WHO/FOOD ADD/71.42Dichlorvos reassessment – application Page 350 of 436
Appendix 1:Occupational Exposure Estimates & Risk Assessment with Engineering ControlsPossible engineering controls reported by US EPA (2000) for mitigation of workerexposure risks to organophosphate (OP) pesticides: [Edited for relevance to proposeddichlorvos applications.]―1. Contained/Closed Mixing and Loading Systems―One engineering control available for mixing and loading pesticides is a closed system.By closed system EPA means a system designed by the manufacturer to enclose thepesticide to prevent it from contacting individuals while it is being handled. Under theWPS [Worker Protection Standard], when a closed mixing and loading system is usedcorrectly and maintained according to the manufacturers‘ operating instructions,handlers may reduce some of the personal protective equipment listed on the pesticidelabeling for mixing and loading activities.“a. Mechanical Transfer System. One type of closed system for liquid formulations isa mechanical transfer system that consists of a probe that is inserted into the pesticidecontainer and seals tightly to the pesticide container to prevent liquid (but notnecessarily any vapor) from contacting handlers or other people. The pesticide is eithertransferred directly from its container to a spray tank, or the container is connecteddirectly to the spray system. Mixers and loaders using this closed system are permittedto wear reduced PPE. A mechanical transfer system usually does not meet the definitionof a closed system under the WPS unless inhalation exposure is not a concern; howeverit is considered an engineering control which greatly reduces dermal exposure.“b. Dry Disconnect System. A dry-disconnect system does not meet the definition of aclosed system under WPS unless it is part of a mechanical closed system. Drydisconnect systems are considered to be an engineering control that reduces potentialworker exposure by reducing leakage of liquid when pipes or hoses are uncoupled fromequipment or from other pipes or hoses. Dry-disconnect systems involve fittingsdesigned by the manufacturer to minimize pesticide leakage at each hose disconnectpoint. These systems are often used in conjunction with mechanical transfer systems.‖“2. Enclosed Cabs“a. Enclosed Cabs for Application and Flagging. The engineering control availablefor handlers applying pesticides using motorized ground equipment or flagging tosupport aerial applications is an enclosed cab. By enclosed cab, EPA means a cabhaving a nonporous barrier that totally surrounds the occupants and prevents contactwith pesticides outside of the cab. By definition, all enclosed cabs protect againstdermal exposure. Some enclosed cabs also provide respiratory protection -- they can beequipped with a ventilation system that provides particulate filtration equivalent to aNIOSH-approved dust/mist respirator or that provides organic-vapor-removing andparticulate filtration equivalent to a NIOSH-approved organic-vapor-removingDichlorvos reassessment – application Page 351 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
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
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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: REFERENCES:APVMA, 2008a. ―DICHLOR
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
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Hazardous Substances (Classes 6, 8,
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Hazardous Substances (Classes 6, 8,
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(a) means piping that—(i) is conn
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Code I29 Regs 51, 52 Signage requir
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Non-HSNO Act controlsAgricultural C
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Appendix K: Overseas regulatory act
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Product Use Further details ofuseSu
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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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