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

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Scenarios (a) and (b). There do not appear to be any effective alternatives currentlyavailable. Thus the loss of the product would result in potential benefits that mayarise from its availability not being realised, which is classed as an absence of benefit(i.e. none), rather than an adverse effect. ERMA New Zealand invites submitters toprovide further information.4.7.51 In terms of effects on trade with respect of the use of dichlorvos for counteringbiosecurity incursions, the level of benefit on trade has been assessed low tomedium. Since there are no adverse effects associated with this use, the positiveeffects outweigh the adverse effects for both Outcome Scenarios (a) and (b). Ifdichlorvos were unavailable (Outcome Scenario (c)), loss of the product would resultin potential benefits arising from its availability not being realised, an absence ofbenefit (i.e. none), rather than an adverse effect.4.7.52 In terms of maintaining industry profitability in the horticulture sector, the two areaswhere effects could be expected to be potentially significant are the asparagusindustry, and glasshouse production of tomatoes, capsicum and cucumber. However,while the volatility of dichlorvos means that residues cannot be detected after a shortnumber of days, Japan, which is a significant market, is moving towards notaccepting product that has had dichlorvos used on it. ERMA New Zealand wouldwelcome further information about the possible ban and the value of product going toJapan. ERMA New Zealand has concluded that the overall benefit of dichlorvos tothe horticulture sector, and specifically the glasshouse production of tomatoes,capsicum and cucumber are at least low, and therefore the positive effects outweighthe adverse effects for Outcome Scenarios (a) and (b). If dichlorvos wereunavailable (Outcome Scenario (c)), loss of the product would result in potentialbenefits arising from its availability not being realised, an absence of benefit (i.e.none), rather than an adverse effect.4.7.53 These assessments are based on limited information, and ERMA New Zealand hasendeavoured to be conservative in terms of estimating the level of benefit and toadopt a risk averse position in terms of estimating the level of risk/cost.4.8 Māori interests and concernsRelationship of Māori to the environment4.8.1 Iwi/Māori interests have not been specifically consulted in the preparation of thisapplication. However ERMA New Zealand has received clear messages at severalhui with iwi/Māori resource managers that unless substances provide clear benefits tooutweigh potential risk, they generally oppose the ongoing use of highly hazardoussubstances. It is likely that, in the absence of further information regarding benefits,submissions from Māori would seek the revocation of the approvals for dichlorvosand its approved formulations.Treaty of Waitangi4.8.2 Section 8 of the Act requires the Authority, when considering applications, to takeinto account the principles of the Treaty of Waitangi. Of particular relevance to thisapplication is the principle of active protection affirmed by the Court of Appeal inthe Lands case (1987).4.8.3 This principle refers to the Crown‘s obligation to take positive steps to ensure thatMāori interests are protected, and to consider them in line with the interestsguaranteed to Māori in Article II of the Treaty. Specifically the Court noted that ―…Dichlorvos reassessment – application Page 64 of 436
the duty of the Crown is not merely passive but extends to active protection of Maoripeople in the use of their lands and waters to the fullest extent practicable‖.4.8.4 Taking into account the principle of active protection requires this application toprovide sufficient evidence to show that the use of dichlorvos and its approvedformulations pose no risk of adverse effects to native/endemic species and/or othertaonga species, ecosystems and traditional Māori values, practices, health and wellbeing.Having considered the information available in relation to the adverse effectsnoted above, ERMA New Zealand considers that retaining the current approvals fordichlorvos and its formulations would be inconsistent with the principle of activeprotection.4.9 International obligations4.9.1 ERMA New Zealand has not identified any international obligations regardingdichlorvos.4.9.2 The use of dichlorvos and formulations has been reviewed by several overseasjurisdictions (Appendix L). These reviews do not pose an obligation on NewZealand but are relevant to consideration of risks and pertinent risk managementmeasures.Dichlorvos reassessment – application Page 65 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
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: outbreak, MAF‘s ability to demons
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
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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
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6BYSTANDER & RESIDENT EXPOSURE & RI
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Children’s incidental ingestion o
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Table XX: Spray driftExposure throu
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Exposure through contactwithcontami
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Conclusions on bystander and reside
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Table XXIII: Dichlorvos Use Scenari
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mixing/loading. Mixing/loading fogg
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7.23 Re-entry for ventilation of in
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REFERENCES:APVMA, 2008a. ―DICHLOR
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Appendix 1:Occupational Exposure Es
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FactorExposure (μg/kg a.i. handled
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Inhalation exposure from cylinder c
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[0.01875 x {(0.018 x 0.05) + (2.68
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With half-face respirator (protecti
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With full-body chemical resistant c
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Appendix 4:Occupational Exposure Es
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With overalls and gloves (protectio
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The Dermal Exposure (D) is 2.06 μg
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TTR = turf transferable residues -
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F = fraction of residue retained on
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TTR = transferable residues - the E
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Public Space ApplicationsScenario (
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ERMA New Zealand‟s comment on the
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Enclosed SpaceAgricultural UseOutdo
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Appendix H: Qualitative Descriptors
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1.3. The likelihood applies to the
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Appendix I: Data from which classif
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Endpoint Units * Dichlorvos Propoxu
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Toxicity mixture calculationsSubcla
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Subclass 9.3 -Ecotoxicity to terres
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Table J.1:Existing controls for dic
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TrackingcontrolsIdentification cont
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Table J.2:Summary of default contro
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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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