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

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egistration subject to conditions; orexempt from registration where the substance is generally recognised as safe; orapprove an agricultural compound without registration under specialcircumstances; orexemption from the requirement to register subject to prescribed conditions.20. The Act provides several mechanisms for managing the risks of the product. Theseinclude:a wide range of conditions of registration can be applied to products requiringregistration or exempt from registration. For example, they can place conditionson importation, manufacture, labelling, packaging, storage, who can sell or use.Limit the term of registrationApproval of operating plansRecognition of persons21. Registration of products (or Trade Name Products) requires the applicant to submitinformation in a range of areas so ACVM Group can determine any risks of theproduct. The main information requirements are:chemistry and manufacturingefficacytarget animal (or crop) safetyresiduesalong with a copy of the label.22. Once the information has been assessed, the risks determined, the ACVM Groupconsiders what conditions of registration are required to ensure any risks areadequately managed. In considering this, the ACVM Group is also obliged toconsider whether any other legislation can provide these controls.23. The ACVM Group maintains a public register on its website of all registeredproducts. The register contains basic information on the product and a crossreference to a scanned version of the label content.24. An important issue to remember is that some of New Zealand‘s trading partners havebanned the use of certain substances in food-producing animals. The ACVM Groupholds a list of these substances and, if unsure of the status of the substance to beused, users must check with the ACVM Group prior to any off-label use.ACVM Act relationship with other NZFSA-administeredlegislation25. There is a complex technical relationship between the ACVM Act and other Actsadministered by NZFSA (and also the Biosecurity Act, Animal Welfare Act,Medicines Act and Hazardous Substances Act which are administered by otheragencies).26. The Food Act, the Animal Products Act and the Wine Act provide required outcomesfor the protection of human health and safety in relation to food and food-relatedproducts. Standards for the management of risks to the safety and integrity of NewDichlorvos reassessment – application Page 426 of 436
Zealand‘s trade in primary produce and for official assurances/certification areprovided by the Animal Products Act and the Wine Act.27. The ACVM Act is designed to provide a ―one stop shop‖ for the assessment andmanagement of those risks as they relate to the use of agricultural compound andveterinary medicines.Food standards under the Food Act 198128. In New Zealand, MRLs are set under the Food Act as food standards, namely theNew Zealand (Maximum Residue Limits of Agricultural Compounds) FoodStandards. These Standards are amended a number of times each year to reflectchanges in the use of agricultural compounds in the production of food.29. MRLs indicate the maximum legal levels at which residues of agriculturalcompounds and veterinary medicines may be present in food for sale in NewZealand.30. MRLs are primarily a tool for monitoring the use of agricultural compounds againstgood agricultural practice (GAP). GAP is not explicitly defined or regulated, but isthe generally-accepted means of producing safe primary produce. GAP is aboutensuring that chemical residues in food are as low as practicable, withoutcompromising the ability of the chemical to successfully do what is intended.31. The MRL Standards are issued by the Minister for Food Safety under Section 11C ofthe Food Act 1981. The MRL Standards have been amended regularly since 1999,when it became the base standard for agricultural compound residues in foods as aparallel standard with regulation 257 of the Food Regulations 1984, which have sincebeen revoked. The frequency of these amendments reflects new agriculturalcompounds coming on the market and changes in the registered uses of compoundsalready available.32. NZFSA administers the MRL Standards but the final decision on any changes to theStandards rests with the Minister for Food Safety. When amending or issuing anyfood standard, including the MRL Standards, the Minister must take into account thefollowing:the need to protect public health;the desirability of avoiding unnecessary restrictions on trade;the desirability of maintaining consistency between New Zealand's foodstandards and those applying internationally;New Zealand's obligations under any relevant international treaty,agreement, convention, or protocol, and, in particular, under theAustralia-New Zealand Joint Food Standards Agreement; andsuch other matters as the Minister considers appropriate.33. In most instances, MRLs are recommended based on the assessment of the productcontaining the active ingredient under the ACVM Act. Under this Act, GAP isestablished and the residue assessment based on this GAP determines the likelyresidues in food and feed crops. Another important consideration is whether thereare any trade issues that requiring addressing with respect to residues and setting ofMRLs. This information forms the basis for setting MRLs in the New Zealand(Maximum Residue Limits of Agricultural Compounds) Food Standards.Dichlorvos reassessment – application Page 427 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
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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
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: 14. Regulatory control of these pro
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
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