DECISION
13 July 2016
Summary
Substance BV2 Surface Spray Insecticide
Application code APP202848
Application type To import or manufacture for release any hazardous substance under Section 28 of the Hazardous Substances and New Organisms Act 1996 (“the Act”)
Applicant Northern Distributors
Purpose of the application To import BV2 Surface Spray, an insecticide containing 10g/kg permethrin for commercial and domestic use for the control of a variety of crawling insect pests
Date application received 30 May 2016
Consideration date 12 July 2016
Considered by The Chief Executive1 of the Environmental Protection Authority (“the EPA”)
Decision Approved with controls
Approval code HSR101153
Hazard classifications 2.1.2A, 6.3B, 6.4A, 6.9B (oral), 9.1A, 9.4B
1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.
2
1. Substance
1.1. BV2 Surface Spray Insecticide is an aerosol containing 10 g/L of permethrin as the active ingredient. It is intended to be manufactured in New Zealand and used by professional and domestic users to control a variety of crawling insect pests on indoor surfaces.
2. Process and notification
Application receipt
2.1. The application was formally received on 30 May 2016 under section 28 of the Act.
Information available for consideration
2.2. The information available for the consideration comprised:
the application form
confidential appendices to the application
the EPA staff advice memorandum.
2.3. I consider that I have sufficient information to assess the application.
Public notification
2.4. This application was not publicly notified under section 53(2) of the Act because it was considered to be unlikely that there would be significant public interest in the application.
Notification to government departments
2.5. In line with section 53(4) of the Act, WorkSafe New Zealand was notified of the application on 3 June 2016. No comments were received.
Legislative criteria for the application
2.6. The application was considered in accordance with section 29 of the Act, taking into account other relevant sections of the Act, the Hazardous Substances Regulations and the Hazardous Substances and New Organisms (Methodology) Order 1998.
3. Hazardous properties, prescribed controls and exposure limits
3.1. The hazard classifications of BV2 Surface Spray Insecticide were determined based on the information provided by the applicant and other available information.
3.2. The classifications that I have applied to this substance are different to those submitted by the
applicant (Table 1). I have not applied the 6.5B and 6.8B classifications indicated by the applicant due to information available that indicates that permethrin does not trigger these classifications. The 9.3B classification is changed to No Data (ND) because mixture rules indicate that permethrin does not trigger a 9.3 classification in this substance, and because data was not available for other components in this substance.
3 Table 1: Hazard classifications of BV2 Surface Spray Insecticide
Hazard Applicant classification EPA classification
Flammable aerosol 2.1.2A 2.1.2A
Skin irritancy 6.3B 6.3B
Eye irritancy 6.4A 6.4A
Contact sensitisation 6.5B ND
Reproductive/ developmental toxicity 6.8B ND
Target organ or systemic toxicity 6.9B (route not specified) 6.9B (oral route)
Aquatic ecotoxicity 9.1A 9.1A
Terrestrial vertebrate ecotoxicity 9.3B ND
Terrestrial invertebrate ecotoxicity 9.4C 9.4C
Prescribed controls
3.3. The hazard classifications of BV2 Surface Spray Insecticide determine a set of prescribed controls specified by the Hazardous Substances Regulations under the Act.
3.4. The prescribed controls set the baseline for how the substance will be managed and include
specifications on how the substance is to be packaged, labelled, stored, disposed of and to a limited extent, how it is transported, handled and used. The prescribed controls also set requirements for safety data sheets, signage and emergency management. These controls form the basis of the controls specified in Appendix A.
Exposure limits set for this substance
3.5. I have not set any exposure limits for any component of this substance at this time.
4. Risk and benefit assessment
Risk assessment
4.1. The risk assessment takes into account the prescribed controls and other legislation such as the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994.
4.2. The risk assessment:
considers the risks posed by BV2 Surface Spray Insecticide
determines whether the risks are outweighed by the benefits
determines whether any variations or additions to the prescribed controls are required to manage the risks of this substance, and identifies controls that may not be applicable or necessary that can, therefore, be deleted.
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Assessment of risks to human health
4.3. I have assessed the human health and environmental risks in accordance with Section 29(1) of the Act. This assessment takes into account the full life cycle of this substance, including import and manufacture, packaging, transport, storage, use and disposal.
4.4. I note that BV2 Surface Spray Insecticide has the same active ingredient at similar concentrations as other insecticides that are already approved, and is intended to be used in similar ways. However, due to the proposed home use of the substance a quantitative risk assessment was undertaken. Details of the quantitative risk assessment are included in Appendix C.
4.5. The results of the quantitative risk assessment for indoor use to control crawling insects indicates that predicted exposures to operators applying BV Surface Spray Insecticide indoors will be below the acceptable operator exposure level (AOEL).
4.6. The predicted exposures to residents (in particular, children) in a treated area following application are also below the AOEL.
4.7. Based on the quantitative risk assessment I consider that the risks to operators and people re-entering the treated area from systemic exposures will be negligible.
4.8. The quantitative risk assessment does not take into account the risks from the skin and eye irritancy hazards of the substance. I consider that these will be managed by the prescribed controls for the substance such that the level of risk is negligible.
4.9. I also consider that the risks to human health from other parts of the lifecycle of the substance, including import or manufacture, storage, transport, and disposal, are negligible.
4.10. Due to the proposed use pattern exposure of BV2 Surface Spray Insecticide to the environment during the use stage of its lifecycle is expected to be very limited. Quantitative exposure modelling was therefore not performed, and I consider that the risks to the environment from the proposed use pattern of this substance are negligible.
4.11. Permethrin is a pyrethroid insecticide. Some pyrethroid insecticides are known to cause paresthesia (a temporary burning, itching, tingling and numbness most common in the face, occurring one to two hours after the beginning of exposure and resolving spontaneously), including permethrin. The risk of paresthesia needs to be communicated to users.
4.12. Adverse effects to human health and the environment could also arise due to the flammability of the substance. However, I consider that the majority of these effects are managed by the prescribed controls for flammable substances. Where this is not the case, additional controls have been proposed to ensure that the resulting level of risk is negligible (see Section 5 below).
Assessment of risks to Māori and their relationship to the environment
4.18 The potential effect of BV2 Surface Spray Insecticide on the relationship of Māori to the environment has been assessed in accordance with sections 5(b), 6(d) and 8 of the Act. Under these sections all persons exercising functions, powers, and duties under the Act shall:
recognise and provide for the maintenance and enhancement of people and communities to provide for their cultural well-being, and
5
take into account the relationship of Māori and their culture and traditions with their ancestral lands, water, taonga and the principles of The Treaty of Waitangi (Te Tiriti o Waitangi).
4.19 In consideration of these obligations, the following sections address the impact of BV2 Surface Spray Insecticide on Māori interests including kaitiakitanga (stewardship), taha hauora (human health), taiao (environment), and Te Tiriti o Waitangi.
4.20 I note that BV2 Surface Spray Insecticide also triggers several hazardous properties that give rise to the potential for cultural risk. Cultural risk includes any negative impacts to taonga species, the environment, and the general health and well-being of individuals and the community. In addition, the introduction and use of hazardous substances has the potential to inhibit the ability of Māori to fulfil their role as kaitiaki.
Taha hauora (human health)
4.21 I note that BV2 Surface Spray Insecticide also triggers several hazardous properties that give rise to the potential for cultural risk in relation to taha hauora e.g. flammability, skin and eye irritancy, target organ/systemic toxicity. For these reasons, BV2 Surface Spray Insecticide poses a risk to taha hauora, in particular the dimensions of taha tinana (physical health and well-being) and taha whanaunga (the responsibility to belong, care for and share in the collective, including relationships and social cohesion).
Mahinga kai (food resources)
4.22 BV2 Surface Spray Insecticide poses potential risk to aquatic organisms and to invertebrates such as bees. This is a concern in respect of culturally significant species such as fish that are an important food source for Māori. If BV2 Surface Spray Insecticide enters waterways, there is potential for this substance to adversely affect taonga food species such as tuna (fresh water eels), inanga (whitebait), koura / kēwai (freshwater cray) or their prey species, for example kōuraura (shrimp) and piriwai (mayfly). This substance may also potentially harm other culturally significant non-food species such as kōkopu (galaxiids) and toitoi (bullies). However, I note that due to the use pattern for this
substance, significant environmental exposure is not expected.
Kupu whakatepe (conclusion)
4.23 In general, the introduction and use of hazardous substances has the potential to inhibit the ability of Māori to fulfil their role as kaitiaki. This is particularly relevant when considering the guardianship of waterways given the ecotoxic nature of some substances to aquatic species and potential risks to human health under prolonged exposure to some substances.
4.24 Based on the information provided, including the use pattern and the controls proposed to be assigned to BV2 Surface Spray Insecticide, the risks to Māori culture or traditional relationships with the
environment are likely to be negligible.
4.25 If BV2 Surface Spray Insecticide is applied in the proposed manner, I consider that it would not breach the principles of the Treaty of Waitangi, particularly the principle of active protection.
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Assessment of risks to society, the community and the market economy
4.26 I have not identified any risks to society, communities or the market economy from the approval of BV2 Surface Spray Insecticide.
New Zealand’s international obligations
4.27 I have not identified any international obligations that may be impacted by the approval of BV2 Surface Spray Insecticide.
The effects of the substance being unavailable
4.28 I have considered the likely effects of the substance being unavailable in accordance with section 29(1) of the Act. I consider that, should this substance not be available, it could lead to reduced consumer choice.
Benefit assessment
4.29 The applicant considers that the approval of BV2 Surface Spray Insecticide will provide the following benefits:
Effective insect control in domestic and commercial settings
Protection from crawling insect-borne diseases
Economic benefits to the manufacturer and greater consumer choice.
4.30 I am satisfied that the availability of BV2 Surface Spray Insecticide will provide beneficial economic effects for some businesses with the potential for flow-on effects to local communities and the New Zealand economy, including improved customer choice and greater competition.
5. Variation and cost-effectiveness of prescribed controls
Modification of controls under section 77 of the Act
5.1 Section 77 of the Act allows the prescribed controls to be substituted, added and/or deleted where:
the adverse effects identified for a substance are different from those which would usually be associated with substances with the same hazard classification
the adverse effects cannot be identified for a substance because of the scientific and technical uncertainty in the available information
the benefits of the substance are retained without significantly increasing the adverse effects.
5.2 I have varied the prescribed controls, as explained in Table 2, and consider that these variations meet the above criteria.
Table 2: Justification for the variations to the prescribed controls (see Appendix A for control variations) Control Justification
T1 TEL, ADE and PDE values
Tolerable Exposure Limit (TEL) values can be set to limit hazardous substances from entering the environment in quantities sufficient to present a risk to people. Acceptable and Potential
7 Control Justification
Daily Exposure (ADE and PDE) values can also be set for substances that may cause an appreciable toxic effect from exposure in food or from environmental media. I consider that setting TEL, ADE, and PDE values is not necessary for this substance as the risk of adverse effects to human health is considered negligible.
E1 Environmental Exposure Limit (EEL) values
EEL values can be set to limit hazardous substances from entering the environment in quantities sufficient to present a risk to it. No EEL values are set for any component of this substance at this time as the risk of adverse effects to the environment has been qualitatively assessed as being negligible, after the addition of controls as set out in Appendix A. The default EEL values are deleted.
E2 Restrictions on use of substances in application areas
Control E2 relates to restrictions on use of substances in application areas. The default controls require the EPA to set an application rate for a class 9 substance that is to be sprayed on an area of land (or air or water) and for which an EEL has been set. As the substance is not intended for application to an area of land and no EEL has been set, this control has been deleted.
E5 Records of use
This control relates to the requirements for keeping records of use for biocidal substances that are applied in areas where they may be likely to enter air or water and leave the place. Based on the proposed use pattern of BV2 Surface Spray Insecticide in an enclosed area, this substance is unlikely to enter air or water outside of the application area. Therefore, this control has been deleted.
F4/E7/AH1 TR1
Approved handler/security and tracking requirements
These controls relate to approved handler and tracking requirements and have been triggered by the flammable and ecotoxic properties of BV2 Surface Spray Insecticide.
I have deleted control E7 as I consider that due to the use pattern of the substance and the pack size of the substance, a significant environmental exposure is not anticipated, and control E7 is therefore not applicable. As the tracking requirements have only been triggered by the ecotoxic properties of the substance, these requirements are also not relevant and I have therefore also deleted the control TR1.
Control F4 is triggered by the flammability of BV2 Surface Spray Insecticide. Given the high hazard associated with a flammable aerosol, I consider that it is appropriate to apply the approved handler controls F4 and AH1. However, during the transport of the substance, the Dangerous Goods Regulations cover the potential risks of the substance. Therefore, for the transport of BV2 Surface Spray Insecticide, I have substituted the requirements of control F4 for alternative requirements in order to retain the benefits of the substance without significantly increasing the adverse effects. The variation to the control is detailed in Appendix A.
I16 Identification and information requirements
This control specifies the requirement for identifying the name and concentration of certain toxic components on the product label and other documentation. Consistent with the guidance provided by the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), this control has been varied to include the revised concentration cut-offs that trigger the requirements for labelling the relevant components present in this substance:
HSNO Classification Cut-off for label (% w/w) Cut-off for SDS (% w/w) 6.1A, B, C, D Any % of component that
would independently of any
Any % that causes the product to classify
8 Control Justification
other component cause the product to classify
6.1E aspiration
Any % of component that would independently of any other component cause the product to classify
Any % of component that would independently of any other component cause the product to classify
8.2, 8.3 Any % that causes the product to classify
Any % that causes the product to classify
6.5A, 6.5B, 6.6A, 6.7A 0.1 0.1
6.6B 1 1
6.7B 1 0.1
6.8A, 6.8C 0.3 0.1
6.8B 3 0.1
6.9A, 6.9B 10 1
Under these regulations, the name and concentration of the following component(s) need(s) to be specified on the label and (M)SDS:
Labelling requirement SDS requirement
None Permethrin
Modification of controls under section 77A of the Act
5.3 Section 77A of the Act also allows the EPA to add, vary, substitute, combine or delete controls if such changes are more effective or more cost-effective in terms of managing the use and risks of the substance, or are more likely to achieve their purpose than the prescribed controls.
5.4 I have, therefore, added the following controls, as set out in Table 3:
Table 3: Justification for the addition of controls and modification to prescribed controls (see Appendix A for additional controls)
Control Justification Water and
Label
The environmental risks associated with the intended use of BV2 Surface Spray Insecticide are considered to be negligible due to the non-dispersive use pattern.
However, due to the high ecotoxicity of the active ingredient permethrin in aquatic environments, I consider it appropriate to restrict application such that the substance must not be applied into or onto water. I consider it appropriate to require that this information also appear on the label for the
substance, to restrict the level of risk to the aquatic environment from application outside of its intended use pattern.
I16 The specified identification requirements for toxic substances do not address the issue of paresthesia (a temporary burning, itching, tingling and numbness most common in the face, occurring 1-2 hours after the beginning of exposure and resolving spontaneously) from the permethrin active ingredient in BV2 Surface Spray Insecticide.
Accordingly, a variation of the identification requirements to address this risk is considered more effective than the default controls in terms of the effect on the management, use and risks of the substance. Consequently, the following variation is applied to BV2 Surface Spray Insecticide:
The following paragraph is added after paragraph (f) of regulation 25:
(g) a warning of the effects of paresthesia and how to avoid it.
Schedule 10 SCHEDULE 10 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS AND SCHEDULED TOXIC SUBSTANCES) TRANSFER NOTICE 2004
9 Control Justification
This schedule prescribes the controls for the unintended ignition of class 2 and 3.1 flammable substances.
The default controls do not address all the risks associated with the unintended ignition of flammable substances, including risks to human health from the effects of fire. These risks may occur where separation of the substances from areas where the general public may be present is inadequate.
Accordingly, I consider that applying the Schedule 10 requirements will be more effective than the default controls with respect to the effect on the management, use and risks of BV2 Surface Spray Insecticide.
Assessment of control modifications
5.5 I consider that the modifications to the controls under section 77A of the Act fulfil the legislative criteria of being, relative to the prescribed controls, either:
more effective with respect to their effect on the management, use, and risks of the substance, or
more cost-effective in terms of their effect on the management, use, and risks of the substance, or
more likely to achieve their purpose.
5.6 I have incorporated these controls into Appendix A of this document.
Review of controls for cost-effectiveness
5.7 I consider that the proposed controls, provided they are complied with, are the most cost-effective means of managing the identified potential risks associated with this substance. The applicant was provided an opportunity to comment on the controls as set out in this decision and no concerns were raised.
6. Risk assessment summary
6.1. I have concluded that the residual level of risk of any potentially significant adverse effects, after taking into account the prescribed controls and any variations to these controls, is negligible, as summarised in Table 4.
Table 4: Summary of risk assessment
Potentially significant adverse effect Residual level of risk
On the environment Negligible
On human health and safety Negligible On Māori culture and traditions Negligible
On the market economy Negligible
On society and the community Negligible On New Zealand’s international obligations Negligible
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7. Decision
7.1 Pursuant to section 29 of the Act, I have considered this application under section 28 of the Act. I have considered the effects of this substance throughout its life cycle, the controls that will be imposed on this substance, and the likely effects of this substance being unavailable.
7.2 I consider that, with controls in place, the risks to human health and to the environment are negligible, and the benefits associated with the release of this substance will outweigh the adverse effects.
7.3 Therefore, I consider that BV2 Surface Spray Insecticide is approved with the controls given in
Appendix A, in accordance with section 29 of the Act and clause 26 of the Hazardous Substances and New Organisms (Methodology) Order 1998.
Dr Allan L Freeth Date: 13 July 2016
Chief Executive, EPA
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Appendix A: Controls applying to BV2 Surface Spray Insecticide
Please refer to the Hazardous Substances Regulations2 for the requirements prescribed for each control.
Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001
Code Regulation Description VariationF1 7 General test certification
requirements for hazardous substance locations
F2 8 Restrictions on the carriage
of flammable substances on passenger service vehicles
F3 55 General limits on flammable
substances
F4 56 Approved handler/security
requirements for certain flammable substances
The following regulation is inserted immediately after regulation 56:
56A Exception to approved handler requirement for transportation of this substance when packaged (1) Regulation 56 is deemed to be complied with if:
(a) when this substance is being transported on land—
(i) by rail, the person who drives the rail vehicle that is transporting the substance is appropriately licensed under the Railways Act 2005; and (ii) other than by rail, the person who drives, loads, and unloads the vehicle that is transporting the substance has a current dangerous goods endorsement on his or her driver licence; and (iii) in all cases, Land Transport Rule: Dangerous Goods 2005 (Rule 45001/1) is complied with; or (b) when this substance is being transported by sea, one of the following is complied with:
(i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A):
(ii) International Maritime Dangerous Goods Code;
or
(c) when this substance is being transported by air, Part 92 of the Civil Aviation Rules is complied with.
(2) Subclause (1)(a)—
(a) does not apply to a tank wagon or a transportable container to which the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 applies; but
2 The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz
12 Code Regulation Description Variation
(b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN Model Regulations.
(3) Subclause (1)(c)—
(a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but
(b) does not apply to—
(i) the handling of this substance in any place that is not within an aerodrome; or
(ii) the loading and managing of this substance for the purpose of aerial spraying or dropping.
(4) In this regulation, UN Model Regulations means the 19th revised edition of the Recommendation on the Transport of Dangerous Goods Model
Regulations, published in 2015 by the United Nations
F5 58, 59 Requirements regarding hazardous atmosphere zones for class 2.1.1, 2.1.2 and 3.1 substances F6 60 – 70 Requirements to prevent
unintended ignition of class 2.1.1, 2.1.2 and 3.1 substances
F11 76 Segregation of incompatible
substances
F12 77 Requirement to establish a
hazardous substance locations if flammable substances are present
F14 81 Test certification
requirements for facilities where class 2.1.1, 2.1.2 or 3.1 substances are present F16 83 Controls on transit depots
where flammable substances are present
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code Regulation Description VariationT1 11 – 27 Limiting exposure to toxic substances through the setting of ADE, PDE or TEL values
No TEL, ADE, or PDE values are set for any component of this substance at this time.
13 Code Regulation Description Variation
T2 29, 30 Controlling exposure in places of work through the setting of WES values
The EPA adopts as WES values for this substance, and each component of this substance, any applicable value specified in WorkSafe New Zealand’s Workplace Exposure Standards and Biological Exposure Indices Document; 8th Edition; June 20163
T4 7 Requirements for equipment
used to handle substances
T5 8 Requirements for protective
clothing and equipment T7 10 Restrictions on the carriage of
toxic or corrosive substances on passenger service vehicles E1 32 – 45 Limiting exposure to ecotoxic
substances through the setting of EEL values
No EEL values are set at this time and the default EEL values are deleted
E6 7 Requirements for equipment
used to handle substances
Hazardous Substances (Identification) Regulations 2001
Code Regulation Description Variation I1 6, 7, 32 – 35,36(1) – (7)
Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability
I3 9 Priority identifiers for ecotoxic substances
I5 11 Priority identifiers for flammable substances
I9 18 Secondary identifiers for all hazardous substances
I11 20 Secondary identifiers for ecotoxic substances
I13 22 Secondary identifiers for flammable substances I16 25 Secondary identifiers for toxic
substances
The following paragraph is added after paragraph (f) of regulation 25:
(g) a warning of the effects of paresthesia and how to avoid it.
3 Or any subsequent version of this Standard approved or endorsed by the EPA. The prescribed Regulations permit one or more WES
values to be set for a substance, therefore, this note is for informative purposes rather than a variation to the prescribed controls
14 Code Regulation Description Variation
The concentration cut-offs that trigger the requirement for labelling of components are set out in the following table:
HSNO Classification Cut-off for label % (I16)
6.5A, 6.5B, 6.6A, 6.7A 0.1
6.6B 1
6.7B 1
6.8A, 6.8C 0.3
6.8B 3
6.9A, 6.9B 10
I17 26 Use of generic names
I18 27 Requirements for using
concentration ranges I19 29 – 31 Additional information
requirements, including situations where substances are in multiple packaging
I21 37 – 39, 47 – 50
General documentation requirements
I23 41 Specific documentation
requirements for ecotoxic substances
I25 43 Specific documentation
requirements for flammable substances
I28 46 Specific documentation
requirements for toxic substances I29 51, 52 Signage requirements
Hazardous Substances (Compressed Gases) Regulations 2004
Code Regulation/description Variation
CG The Hazardous Substance (Compressed Gases) Regulations 2004 prescribe a number of controls relating to compressed gases including aerosols and gas cylinders
Hazardous Substances (Disposal) Regulations 2001
Code Regulation Description Variation
D2 6 Disposal requirements for flammable
substances
D4 8 Disposal requirements for toxic and corrosive substances
15
Code Regulation Description Variation
D5 9 Disposal requirements for ecotoxic
substances
D6 10 Disposal requirements for packages D7 11, 12 Information requirements for
manufacturers, importers and suppliers, and persons in charge D8 13, 14 Documentation requirements for
manufacturers, importers and suppliers, and persons in charge
Hazardous Substances (Emergency Management) Regulations 2001
Code Regulation Description Variation
EM1 6, 7, 9 – 11 Level 1 information requirements for suppliers and persons in charge EM6 8(e) Information requirements for toxic
substances
EM7 8(f) Information requirements for ecotoxic substances
EM8 12 – 16, 18 – 20
Level 2 information requirements for suppliers and persons in charge EM9 17 Additional information requirements
for flammable and oxidising substances and organic peroxides EM10 21 – 24 Fire extinguisher requirements EM11 25 – 34 Level 3 emergency management
requirements: duties of person in charge, emergency response plans
EM13 42 Level 3 emergency management
requirements: signage
Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001
Code Regulation Description Variation
AH1 4 – 6 Approved Handler requirements (including test certificate and qualification requirements
Refer to control F4
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Code Regulation Description Variation
Tank Wagon
4 – 43, as applicable
Controls relating to tank wagons and transportable containers
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Additional controls
Definitions
Unless defined below, terms used in the controls have the same meaning as defined in the Act or regulations made under the Act.
Term Definition
Water
Means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application.
Wide dispersive
Refers to activities which deliver uncontrolled exposure - also refer to:
http://www.epa.govt.nz/Publications/ER-IS-33-2.pdf Code Section of
the Act Control
Water 77A This substance must not be applied into or onto water
Label 77A The substance label must include the following statement, or words to the same effect:
This substance must not be applied into or onto water Unintended
ignition
Schedule 10 SCHEDULE 10 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS AND SCHEDULED TOXIC SUBSTANCES) TRANSFER NOTICE 2004 This schedule prescribes the controls for unintended ignition of class 2 and 3.1 hazardous substances. The requirements of this schedule are detailed in the consolidated version of the Hazardous Substances (Dangerous Goods and Schedule Toxic Substances) Transfer Notice 2004, available from
http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf The following clause replaces Clause 1 of Schedule 10 of the Hazardous
Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004:
This Schedule applies to this substance.
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Appendix B: Applicant and Staff hazard classifications of the mixture
Table B1 Applicant and Staff classifications of the mixture
Hazard Class/Subclass
Mixture classification Method of classification
Remarks Applicant’s
classification
Staff’s classification
Mixture data Read across Mixture rules4
Class 1 Explosiveness - ND
Class 2, 3 & 4 Flammability 2.1.2A 2.1.2A Flammable
aerosol Class 5 Oxidisers/Organic
Peroxides - ND
Subclass 8.1 Metallic
corrosiveness - ND
Subclass 6.1 Acute toxicity (oral) - ND Subclass 6.1Acute toxicity
(dermal) - ND
Subclass 6.1 Acute toxicity
(inhalation) - ND
Subclass 6.1 Aspiration hazard - NA Subclass 6.3/8.2 Skin
irritancy/corrosion 6.3B 6.3B Components A
and C Subclass 6.4/8.3 Eye
irritancy/corrosion 6.4A 6.4A Component A
Subclass 6.5A Respiratory
sensitisation 6.5A ND
Change to classification of permethrin
Subclass 6.5B Contact
sensitisation 6.5B ND
Change to classification of permethrin
Subclass 6.6 Mutagenicity - ND
Subclass 6.7 Carcinogenicity - ND
Subclass 6.8 Reproductive/
developmental toxicity - ND
4 Use of mixture rules may not adequately take into account interactions between different components in some circumstances and must be considered of lower reliability than data on the mixture itself.
18 Hazard Class/Subclass
Mixture classification Method of classification
Remarks Applicant’s
classification
Staff’s classification
Mixture data Read across Mixture rules4
Subclass 6.8 Reproductive/
developmental toxicity (via lactation)
- ND
Subclass 6.9 Target organ
systemic toxicity (oral) 6.9B 6.9B Permethrin
Subclass 9.1 Aquatic ecotoxicity 9.1A 9.1A Permethrin
Subclass 9.2 Soil ecotoxicity - ND
Subclass 9.3 Terrestrial
vertebrate ecotoxicity - ND
Subclass 9.4 Terrestrial
invertebrate ecotoxicity 9.4A 9.4B
Permethrin. The difference relates to application of the mixture rule.
-: No information provided by the applicant
NA: Not Applicable --> For instance when testing is technically not possible: testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g.
very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the substance required in certain studies may not be possible.
ND: No Data or poor quality data (according to Klimisch criteria5) --> There is a lack of data for one or more components.
No: Data are available for the formulation or for all components and classification is not triggered.
5 Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)
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Appendix C: Quantitative human health risk assessment
Overview
1. The RIVM ConsExpo model was used to assess exposure to the substance. This determined exposure to a home user during application and a child from post-application contact with the sprayed surface.
2. In two previous applications the EPA has assessed exposures to permethrin from broadly similar products. This assessment has used the same Acceptable Operator Exposure Limit (AOEL) and dermal absorption parameters that were used in the applications for Ready to Used Insecticidal Dust
(APP202330) and Permethrin IGR Concentrate (APP202765). The values are set out in Tables C1 and C2.
Table C1: Derivation of an AOEL
Available international AOELs
Key systemic effect
NOAEL (LOAEL) mg/kg bw/Day
Uncertainty factors
AOEL mg/kg bw/Day
Staff’s
modifications Remarks
Permethrin US EPA (Acute Reference Dose &
Chronic Reference Dose)
Neurotoxicity (aggression, abnormal and/or decreased movement) and increased body temperature
25 100 0.25 None
Value appropriate for acute and sub-chronic exposure scenarios
Table C2: Inputs for the risk assessment:
Active Physical form
Concentration of each active (%)
Dermal absorption (%)
Concentrate Spray
AOEL mg/kg bw/day
Permethrin liquid 11 6 30 0.25
3. As information on dermal absorption of permethrin in the present formulation was not available the staff used default values. For pesticides, the EPA adopted default values proposed by Aggarwal et al (20156), which are based on a review of a robust data set of 295 in vitro human dermal absorption studies with over 150 agrochemical active ingredients. These default values are 6% for liquid concentrates and 30%
for spray dilutions.
6 Aggarwal et al. 2015 Assessment of an extended dataset of in vitro human dermal absorption studies on pesticides to determine default values, opportunities for read-across and influence of dilution on absorption. Regul Toxicol Pharmacol 72: 58-70. http://www.sciencedirect.com/science/article/pii/S0273230015000458
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Risk assessment for indoor treatment with permethrin of crawling insects
4. The risk assessment has been conducted using the ConsExpo model. ConsExpo is a set of coherent, general models developed to estimate and assess the exposure to substances from consumer products and their uptake by humans. ConsExpo was originally developed in Europe for consumer exposure assessment for New and Existing Substances in the scope of European Directive 67/548/EC and Council Regulation 793/93/EC, respectively. Thereafter, ConsExpo was extended to also assess exposure of consumers to biocides.
5. The ConsExpo approach for spray applications has been used for the exposure assessment. This used the recommended inputs for aerosols used to control crawling insects indoors. Exposure has been assessed for an adult spraying, and for a child (10.5 months old) crawling over a treated area. For a child the exposure is assumed to occur via the skin and from hand-to-mouth contact.
6. The model provides an estimate of acute exposure (i.e. exposure on the day of application) and chronic exposure (an average exposure for a year based on use for the number of days the substance is used per year).
Operator exposure assessment
7. The operator exposure assessment used the following ConsExpo scenario: ‘General surface application with an aerosol spray’. Key inputs for the operator exposure assessment, and the outcomes of the assessment are summarised below.
Table C3: Key input values for operator exposure assessment
Parameter Value Comment
Exposure duration (contact with
treated surface) Spraying: 240 minutes Default value7
Exposure frequency 9 times per year Default value
Spray duration 10 minutes Default value
Body weight 65 kg Default value
Room volume Spraying: 58m3 Default value
Room height 2.5 m Default value
Ventilation rate Spraying: 0.5 hr-1 Default value
Weight fraction compound
Concentrate:
permethrin (1%) (no dilution/mixing)
0.01 permethrin (fraction)
7 Reference to default values in this table means the default values provided in the guidance for the ConsExpo v4.1 model, unless otherwise stated.
21 Applied amount mixing and
loading - NA
Mass generation rate 2.0 g/sec Default value
Airborne fraction 1
Default value surface sprays;
median of the initial particle distribution < 50 µm
Weight fraction non-volatile 1 Default for trigger sprays
Density non-volatile 0.7 Default for aerosol sprays
Inhalation cut-off diameter 15 µm Default value
Inhalation rate 34.7 m3/day Default value light exercise
Table C4: Results of the operator exposure assessment
Exposure route Permethrin - Spraying
Internal dose (mg/kg bw)
Inhalation (acute) 0.0134 mg/kg bw
Dermal 0.0462 mg/kg bw
Oral 0.0
Total 0.0596 mg/kg bw
Total exposure from spraying 0.0596 mg/kg bw
RQ 0.24
*RQ: risk quotient (exposure/AOEL)
8. The predicted operator exposure to permethrin from spraying BV2 Surface Insecticide indoors is lower than the AOEL; therefore there are no concerns about the potential risks to the health of the user.
Risk assessment for exposure of a child following application
9. Exposure for a child after application has been calculated using the ConsExpo inputs for ‘Exposure after application of general surface spray’. Key inputs for the exposure assessment and the results of the assessment are summarised in Tables C5 and C6 below.
22 Table C5: key input values for child exposure assessment
Parameter Value Comment
Exposure duration (contact with
treated surface) 60 minutes Default value
Body weight 8.69 kg Default value for child of 10.5
months Dermal exposure
Transfer coefficient 0.18 m2/hr
This value is based on a more recent US EPA value than the default value in ConsExpo (0.6 m2/h).
Dislodgeable amount 3.1 g/m2 Default value
Uptake fraction 30% Default dermal absorption
value for spray dilutions
Rubbed surface 22 m2 Default value
Oral exposure
Amount Permethrin: 0.0093 mg/min
Calculated as 10% of the amount of product that gets onto a child’s skin*
* The model predicts an external dermal exposure to permethrin of 0.642 mg/kg bw for an exposure period of 60 minutes. The input parameter is given as mg/min. The amount ingested in 60 min can be calculated as {0.642 mg/kg bw x 8.69 kg x 0.1}/60
= 0.0093 mg/min.
Table C6: Results of the child exposure assessment
Exposure route Permethrin -
Acute internal dose (mg/kg bw)
Dermal 0.17
Oral 0.0642
Total (integrated) 0.24
RQ* 0.96
*RQ: risk quotient (exposure/AOEL)
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# The dermal exposure predicted by the model (0.642 mg/kg bw for permethrin) was reduced by 10% as it is assumed that 10% of the amount on the skin is ingested. In addition it was assumed that the dermal absorption was 30 % (default assumption).
10. Residential exposure to permethrin following application indoors is slightly lower than the AOEL; therefore there are no concerns about the potential risks to human health. It should be pointed out that although the predicted exposure is only slightly lower than the AOEL, these calculations are conservative. For
example, default dermal absorption values were used and assumptions such as the total area of floor area contacted by a toddler in one hour are conservative.
Conclusions of the risk assessment
11. The results of the quantitative risk assessment for indoor use to control crawling insects indicate that predicted exposures to operators applying BV Surface Spray indoors and that the predicted exposures to residents (i.e. children) following application are both below the AOEL.
12. In ConsExpo it is assumed that no PPE is worn. The quantitative risk assessment for this use indicates that the exposure of a non-professional user, without PPE, is substantially below the AOEL. However, the modelling assesses risks from systemic exposures and does not address risks from site of contact effects. It is therefore appropriate to retain requirements for PPE to protect against the skin and eye irritation hazards posed by the substance.
