EVALUATION AND REVIEW REPORT · identification and assessment of effects assumes the controls are...

EVALUATION AND REVIEW REPORT

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Application for approval to import or manufacture RF-017 for release July 2011

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Application for approval to import or manufacture RF-017 for release (ERMA200582)

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Executive Summary

Background information

1. Renovo Technologies Limited has applied to import or manufacture RF-017 as an insecticide

for combination with surface coatings prior to application.

2. RF-017 is a liquid containing deltamethrin as the active ingredient.

3. Deltamethrin is present in other pesticides currently available in New Zealand. Currently, there

are no products approved in New Zealand for the same use as RF-017.

Classification

4. The staff of the Environmental Protection Authority (―the staff‖) have classified RF-017 based

on its composition and the effects of its components:

Hazardous Property Staff Assessment

Acute toxicity (oral) 6.1D

Eye irritancy 6.4A

Target organ toxicity 6.9B

Aquatic ecotoxicity 9.1A

Ecotoxicity to terrestrial vertebrates 9.3B

Ecotoxicity to terrestrial invertebrates 9.4A

Risk Assessment

5. The staff‘s exposure modelling indicates that the risk to operators are non-negligible even if full

Personal Protective Equipment (PPE) is used during mixing, loading and application of the

substance.

6. Risks to bystanders, and to human health and safety during all other stages of the lifecycle, are

considered to be negligible with the proposed controls in place.

7. The staff‘s environmental exposure modelling indicates negligible risks to the environment from

the use of RF-017 with the proposed controls in place.

8. The staff consider that a low level benefit may be derived from allowing the use of RF-017.

Controls

Default controls

9. A number of default controls are prescribed as a consequence of the toxicity and ecotoxicity

classifications for RF-017.

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10. The staff propose that the default controls for RF-017 be modified, such that:

No Tolerable Exposure Limits (TELs) are set for any components of RF-017 at this time.

A Workplace Exposure Standard (WES) is set for component D of RF-017.

No Environmental Exposure Limits (EELs) are set at the present time and any default

values are deleted.

Approved handler requirements are deleted.

11. The staff consider that it is appropriate for certain other variations to be made to the default

controls. These variations are discussed in Section 4 of this E&R Report and further in

Appendix 3.

Additional controls

12. The staff propose the addition of a number of labelling and use controls for this substance

under section 77A.

Conclusion

13. The staff‘s risk assessment indicates that:

there is a low level of risk to operators using RF-017; and

there are three low benefits to be gained from the availability RF-017.

14. The staff have proposed additional controls to mitigate the risk to operators and consider that,

with these controls in place, and noting that operators will be aware of the risks involved, the

overall level of benefit provided by the availability of RF-017 outweighs the low level of risk that

occurs to operators. Therefore, the staff consider that the application may be approved in

accordance with clause 27, with the controls documented in Appendix 4.

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Table of Contents

Executive Summary ............................................................................................................................... 2

1. The Application ............................................................................................................................ 5

2. The substance, its lifecycle and its hazardous properties ..................................................... 6

3. Identification and assessment of risks, costs and benefits ................................................... 8

4. Setting controls ......................................................................................................................... 18

5. Approach to risk ........................................................................................................................ 21

6. Overall evaluation and recommendation ................................................................................ 22

Appendix 1: Classification of RF-017 ................................................................................................ 23

Appendix 2: Risk Assessment ........................................................................................................... 25

Appendix 3: Controls for RF-017 and their variations. .................................................................... 39

Appendix 4: Proposed controls for RF-017 ...................................................................................... 43

Appendix 5: Parties notified ............................................................................................................... 49

Appendix 6: References ...................................................................................................................... 51

Appendix 7: Confidential material ..................................................................................................... 52

Supplementary Information ................................................................................................................ 53

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1. The Application

1.1. The application details are summarised in Table 1.

Table 1 Details of the application

Application Code ERMA200582

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‖)

Application Sub-Type Notified - Category A

Applicant Renovo Technologies Limited

Date Application Received 16 August 2010

Submission Period 6 October 2010 – 18 November 2010

Consideration Due Due to delays in completing this E&R Report the Authority

potponed the consideration until 22 August 2011.

Purpose of the Application To manufacture RF-017 containing deltamethrin as an

insecticide for use in coatings.

Parties Notified On 6 October 2010 the following were notified

the Minister for the Environment,

the Department of Labour,

the Ministry of Health,

interested parties listed in Appendix 5, and

the public1.

Submissions received One submission was recieved.

The submission opposed the approval of the substance, and

was made by the National Beekeepers‘ Association. The

submitter noted that deltamethrin is in a concentrated form.

Information assessed The application

Confidential appendices

The submission

1.2. This report should be read in conjunction with the attached Supplementary Information which

contains information on:

The legislative criteria.

Approach to risk assessment.

Human health and environmental exposure risk assessment.

1 The application was advertised in the Dominion Post, the New Zealand Herald, The Christchurch Press and the Otago

Daily Times and placed on the ERMA New Zealand website.

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Decision pathway used in the decision process.

Discussion on controls.

1.3. The staff of the Environmental Protection Authority (―the staff‖) consider that it accessed

sufficient information to undertake a full assessment of the substance from a scientific and

technical perspective and that there are no other significant uncertainties that need to be

considered by the Authority.

2. The substance, its lifecycle and its hazardous properties

The substance and its lifecycle

2.1. RF-017 is intended to be used as an insecticide to be combined with coatings prior to

application. RF-017 contains the active ingredient deltamethrin.

2.2. The applicant has provided the following details about the lifecycle of RF-017.

Manufacture

2.3. RF-017 will be manufactured in New Zealand. The hazardous components in RF-017 are not

new to New Zealand and are stored or used at the manufacturing site in other products. The

manufacturing facility is bunded to prevent uncontrolled spillage and equipment is constructed

and operated to handle toxic and ecotoxic substances. There is warning signage and restricted

access.

Packaging

2.4. After the quality control check following manufacture RF-017 will be packaged in approved

containers of 52mL, 130mL and 260mL. The packaging will be opaque or semi-opaque high

density polyethylene (HDPE) containers with child resistant caps. The label will be affixed to

the outside of the container and include information to comply with the HSNO regulations.

Transport and distribution

2.5. RF-017 will be transported within New Zealand in cardboard boxes to a distribution company

within New Zealand or for export. Any export shipments will be by sea freight. Transport within

New Zealand will be via road transport operators approved to handle class 9 Dangerous Goods

meeting the Land Transport regulations and NZS5433. Although it is unlikely the packaging

would rupture or leak in normal use situations there is potential risk of a spillage in the event of

a traffic accident. Under such circumstances site management would be by the emergency

services to facilitate the containment of the liquid spill and to oversee the recovery of liquid and

site clean up. A Safety Data Sheet will also be available. 52mL, 130mL or 260mL bottles for

sale to the general public or paint contractors via retail outlets or exported.

Use

2.6. RF-017 will be mixed with coatings just prior to application and may be used in any coatings

applied to domestic, commercial or industrial dwellings and structures. This provides the

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coated surface with insect resistance, while having benefits of the active ingredient bound in a

film. RF-017 will not be used in coating to be applied to surfaces which contact food products.

This and other limitations are provided in the directions for use and will be detailed on the

product label. Bottle sizes have been designed to allow a whole bottle to be mixed with the

most common coating pack sizes. 52mL of RF-017 per 4L coating or 130mL of RF-017 per 10L

coating. RF-017 is used for insect control on painted surfaces and it suitable for the control of

most insects.

Disposal

2.7. Containers will be rinsed with the coating prior to disposal. The rinsate will be added to the bulk

coating to be applied according to the product label. Rinsed containers will be left until the

coating has dried and cured and can then be disposed of. Specific warnings would be provided

on the label not to dispose of the product or used packaging into waterways or drains because

of the aquatic toxicity of deltamethrin.

Classification of the substance

2.8. The staff have classified RF-017 based on the composition of RF-017 and the effects of its

components. The classifications proposed by the staff are different to those proposed by the

applicant (Table 2).

Table 2 Summary of the applicant‘s and the staff‘s classifications of RF-017

Hazardous Property Applicant’s

Assessment

Staff Assessment

Acute toxicity (oral) 6.1D 6.1D

Skin irritancy 6.3B -

Eye Irritancy 6.4A 6.4A

Target Organ Toxicity - 6.9B

Aquatic ecotoxicity 9.1A 9.1A

Ecotoxicity to terrestrial vertebrates 9.3B 9.3B

Ecotoxicity to terrestrial

invertebrates

9.4A 9.4A

2.9. The difference in classification between the staff and the applicant‘s assessments is due to

different application of the mixture rules.

Regulatory context

2.10. The staff note that the importation, manufacture, transport, use and disposal of the substance

will be subject to other legislation such as the Health and Safety in Employment Act 1992, the

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Resource Management Act 1991 and the Land Transport Act 1998 (see Supplementary

Information, Section 2).

Default controls

2.11. The HSNO Regulations specify a number of controls based on the classification of the

substance. These default controls are designed to mitigate the potential risks associated with

each of the hazardous properties and are listed in Appendix 3. The Authority is able to vary the

default controls and impose controls under sections 77 and 77A to produce a set of controls

relevant to RF-017. Variations and additional controls are considered in Section 4 of this

report.

2.12. The analysis of risk takes into account the controls that derive from the HSNO Regulations (in

particular the default controls identified in Appendix 3) and from other legislation. The

identification and assessment of effects assumes the controls are in place.

3. Identification and assessment of risks, costs and benefits

3.1. The staff‘s identification and assessment of risks and costs (adverse effects) and benefits

(positive effects) is set out in this section and supported by information in Appendix 2 and the

Supplementary Information (Sections 3 and 4).

Submissions

3.2. One submission was received in response to the notification of this application. The National

Beekeepers‘ Association opposes the approval of the substance for reasons primarily around

the toxicity and ecotoxicity of deltamethrin.

3.3. The reasons identified by the submitter for opposing the application are:

The deltamethrin in RF-017 is in a concentrated form;

Deltamethrin is one of the five most common pesticides found in fruit and vegetables;

Deltamethrin is a neurotoxin and poses a risk to public health;

Deltamethrin poses a risk to the environment particularly by causing algal blooms in the

aquatic environment;

Deltamethrin is considered toxic to bees directly resulting in reducing bee populations

and their associated pollination service; and

RF-017 is classified as toxic to terrestrial invertebrates and this will not be minimised by

smaller packs, labels for use or default controls.

3.4. The submitter requested that there should be an immediate review on the use and handling

practices of deltamethrin in New Zealand.

3.5. The staff note the concerns expressed by the submitter in relation to the potential effect

deltamethrin could have on the environment and terrestrial invertebrates. However, the use

pattern of this product is not widely dispersive and, given that it is added to surface coatings for

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application to surfaces the staff consider the risks to the environment and terrestrial

invertebrates are negligible.

3.6. The staff acknowledges that deltamethrin is a neurotoxin. However, it is noted that the staff are

proposing additional stringent controls for the use of RF-017 such as the use of gloves, label

statements warning of nerve damage, maximum periods of time users should be exposed to

the substance for, and using RF-017 in well ventilated areas.

Human health effects

3.7. RF-017 has been classified as being an acute oral toxicant, an eye irritant (6.4A), and as a

target organ toxicant (6.9B).

3.8. The classification of RF-017 also indicates that this substance may cause chronic effects

(6.9B). The staff note that chronic effects normally require repeated exposure for the adverse

effect to occur.

3.9. Quantitative modelling (Appendix 2) of operator exposure indicates that the risks are significant

even when full PPE (with or without a respirator) is used during mixing, loading and application

of the substance. However, the staff note that quantitative risk assessment does not take into

account the additional controls the staff are proposing.

3.10. The results of the qualitative and quantitative assessment of the human health risks associated

with RF-017 (see Appendix 2) are summarised in Table 3.

Environmental effects

3.11. RF-017 has been classified as being very toxic to organisms in the aquatic environment (9.1A),

toxic to terrestrial vertebrates (9.3B) and very toxic to terrestrial invertebrates (9.4A).

3.12. Table 4 summarises the results of the qualitative assessment undertaken (see Appendix 2) to

identify the impact of potential risks at each stage in the substance‘s lifecycle.

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Table 3 Qualitative and quantitative assessment of human health risks

Lifecycle Description Likelihood Magnitude Matrix Comment Effect

level

Manufacture

and packaging

Acute effects

Acute toxicity (oral)

Highly

improbable

Moderate Negligible Workers handling the substance will be aware of the hazards and

the measures that need to be undertaken to ensure their own

safety. Manufacturing and packaging facilities will be required to

meet the HSNO requirements for equipment, emergency

management and Personal Protective Equipment (PPE).

Compliance with HSNO information provisions (e.g. labels,

advertising, Safety Data Sheets (SDS), and Department of

Labour (DoL) Health and Safety requirements will also apply.

Negligible

Eye irritancy

Chronic effects

Target organ

toxicity

Highly

improbable

Major Low While the qualitative descriptors indicate a low level of risk driven

by the major chronic effects, the staff note that these processes

will be required to meet the HSNO requirements for equipment,

emergency management and provision of information as well as

Health and Safety regulations. The staff consider that these

requirements will make the likelihood of exposure that would lead

to a chronic effect so highly improbable that the level of risk for

the chronic toxic adverse effects is negligible.

Negligible

Importation,

transport,

storage

Acute effects

Acute toxicity (oral)

Highly

improbable

Moderate Negligible Workers and bystanders will only be exposed to the substance

during this part of lifecycle in isolated incidents where spillage

occurs. HSNO controls (e.g. labels, SDS) and adherence to the

Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime

Negligible

Eye irritancy

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level

Transport Act 1994 (as applicable) will apply.

Chronic effects

Target organ

toxicity

Highly

improbable

Major Low It is highly improbable that users or bystanders could be

repeatedly exposed to RF-017 during importation, transport or

storage to result in target organ toxic effects, given that the

people involved in the transport and storage of RF-017 will have

the necessary skills and knowledge (e.g. via information provided

on SDS) to reduce the risk to human health for the importation,

transport and storage of the substance to negligible.

Negligible

Use

(infrequent,

one-off)

Acute effects: operators (mixing, application)

Acute toxicity (oral) Highly

improbable

Moderate Negligible The staff consider that it is highly improbable that non-

commercial users are likely to inadvertently ingest sufficient

quantities of RF-017 to result in a moderate adverse effect.

The staff consider that use of adequate levels of Respiratory

Protection Equipment (RPE) is unlikely to occur by non-

commercial users. In order to reduce the level of risk to

negligible, the staff consider that a number of additional controls

are required:

Restricting application to non-spray methods;

Mixing RF-017 into paint and application of paint containing RF-

017 should be carried out in a well-ventilated areas, until the

paint has dried, with an equivalent label statement;

While the staff consider that it is good practice for users of the

substance to wear eye-protection, the staff consider that, in a

non-commercial/ infrequent usage situation, the likelihood of

Negligible

Unlikely Moderate Low

Eye irritancy Highly

improbable -

unlikely

Minimal Negligible

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level

adverse effects occurring are increased through eye-protection

not being used. However, the staff consider that, given the

reversible nature of the adverse effects, that the level of risk of

eye irritancy is negligible.

Acute effects: bystanders


improbable

Moderate Negligible Bystanders are assumed to not be wearing PPE. However, the

staff consider that bystanders are not likely to intentionally stay in

a location where mixing or application is being undertaken.

The staff also note:

the application method restriction to non-spray methods.

Accordingly, the staff consider it is unlikely that a bystander could

ingest sufficient RF-017 to cause even a moderate adverse

effect.

Negligible

Unlikely Minor Low


improbable –

very unlikely

Minimal Negligible

Chronic effects: operators (mixing, application)

Target organ

toxicity

Quantitative assessment indicates that there are high chronic risks posed to human health and safety of applicators

from one-off / infrequent (i.e. non-commercial) use, and that those risks are significant (low). A number of restrictions

are proposed to avoid the chronic adverse effects that may occur, and reduce the level of risk to negligible:

Specific levels of PPE (i.e. gloves to avoid dermal exposure) are used; and

Application is restricted to non-spray methods; and

The duration of exposure of the applicator during application is restricted by:

limiting package size to 52mL; and

introducing a time limit for use of RF-017-containing paint once mixed; and

Negligible

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level

mix and apply paint in a well ventilated area, and maintain ventilation until the painted surfaces have

dried, with an equivalent label statement; and

a label statement indicating that prolonged, repeated exposure may result in nerve damage and

should be avoided.

Chronic effects: bystanders

Target organ

toxicity

Very unlikely Major Low Multiple exposure to bystanders could occur, as it is reasonable

to assume that multiple applications could occur at a single

location and the exposure of individuals could occur if access is

not restricted until the painted surfaces are dry and atmospheres

ventilated. With the additional control proposed for use in

ventilated areas, the staff consider that the level of risk to

bystanders is reduced to negligible.

Negligible

Use

(frequent,

professional,

commercial)

Acute effects: operators (mixing, application)


improbable

Moderate Negligible Given the requirements for personal protective equipment (RPE

and PPE), and compliance with HSNO information provisions

(e.g. labels, advertising, Safety Data Sheets (SDS), and

Department of Labour (DoL) health and safety requirements, it is

highly improbable that operators or bystanders could

inadvertently be exposed to sufficient quantity of RF-017 to result

in a minimal to moderate adverse health effect.

Negligible

Eye irritancy Minimal

Acute effects: bystanders

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level

Acute toxicity (oral) Unlikely Moderate Low Bystanders are assumed to not be wearing PPE. While it is

unlikely that a bystander could consume sufficient deltamethrin to

cause even a minor adverse effect, depending on the application

method and the vicinity of the bystander to the application. The

staff consider that bystanders are not likely to intentionally stay in

a location where mixing or application is being undertaken , but

that the quantities of RF-017 (and hence atmospheric

concentrations of deltamethrin) used at a particular location may

be significantly greater than in a domestic setting and notes the

following:

bystanders should be restricted from the application area until the

painted surfaces are dry

the application method restriction to non-spray methods.

The staff consider that these additional measures will be

sufficient to reduce the acute adverse effects to bystanders to

negligible.

Negligible


improbable

Minimal Negligible

Chronic effects: operators (mixing, application)

Target organ

toxicity

Unlikely Moderate Low Quantitative assessment indicates that the chronic risks to

human health and safety of applicators from frequent (i.e.

commercial) use are significant. The staff propose a number of

restrictions that should be applied to RF-017 usage to minimise

chronic exposure risks. The staff also note the uncertainty

regarding the operator re-exposure period and its determination

of acceptable on-going exposure durations. The staff have used

their expert judgement to estimate an acceptable exposure

period (2 weeks in every 4 weeks), but given the uncertainty

Low

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level

surrounding this estimation considers that the risk remains low:

Specific levels of PPE and RPE are used; and

Application is restricted to non-spray methods; and

The duration of exposure of the applicator during

application is restricted by:

introducing a time limit for use of RF-017-containing

paint once mixed; and

Mix and apply paint in a well ventilated area, and

maintain ventilation until the painted surfaces have

dried, with an equivalent label statement; and

Label statements indicating that:

(a) prolonged, repeated exposure may result in

nerve damage and should be avoided; and

(b) repeated, daily exposure for more than 2

weeks every month should be avoided.

Chronic effects: bystanders

Target organ

toxicity

Very unlikely Major Low Multiple exposure to bystanders could occur, as it is reasonable

to assume that multiple applications could occur at a single

location and the exposure of individuals could occur is access is

not restricted until the painted surfaces are dry and atmospheres

ventilated. With additional controls, the staff consider that the

level of risk to bystanders is reduced to negligible.

Negligible

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level

Disposal

Acute effects


improbable

Minimal Negligible The applicant indicates that the preferred method is to use the

product according to label directions; however, any unused

product can be returned to the applicant. Containers should be

triple rinsed and can then be disposed of to an AgRecovery

collection point. Disposal of the substance and used containers

in accordance with the requirements of the Hazardous

Substances (Disposal) Regulations 2001 and the Resource

Management Act 1991will reduce the opportunity for individuals

to be exposed.

Negligible

Eye irritancy

Chronic effects

Target organ

toxicity

Highly

improbable

Major Low It is highly improbable that users or bystanders could be

repeatedly exposed to RF-017 during disposal to result in target

organ toxic effects, given that the people disposing of RF-017 will

have the necessary skills and knowledge (e.g. via information

provided on SDS) to reduce the risk to human health for the

disposal of the substance to negligible.

Negligible

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Table 4 Qualitative and quantitative assessment of environmental risks

Lifecycle

Stage

Potential

Adverse

Effect

Likelihood Magnitude Matrix Comment Effect level

Manufacture,

importation,

transport and

storage

Death or

adverse effects

to aquatic

organisms or

terrestrial

invertebrates

and vertebrates.

Highly

improbable

Moderate Negligible Given adherence to the HSNO controls (and the Land Transport

Rule 45001, Civil Aviations Act 1990 and Maritime Transport Act

1994 (as applicable) the staff consider a spill to be highly

improbable. Furthermore, a spill is likely to lead to localised

effects only involving small quantities of the substance.

Negligible

Use Death or

adverse effects

to aquatic

organisms or

terrestrial

invertebrates

and vertebrates

Quantitative assessments of the risks to the environment have not been undertaken for the use of RF-017. The use

pattern is not considered wide dispersive and thus, the staff consider the risks to aquatic organisms and terrestrial

vertebrates and invertebrates from the use of RF-017 are negligible.

Negligible

Disposal Death or

adverse effects

to aquatic

organisms or

terrestrial

invertebrates

and vertebrates

Highly

improbable

Moderate Negligible Users will in most cases use all of the substance by its normal use

as an additive to coatings. If RF-017 is disposed of by means

other than use, this will be in accordance with the requirements of

the Hazardous Substances (Disposal) Regulations 2001 and the

Resource Management Act 1991.

Negligible

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Benefits

3.13. The applicant considers that the availability of RF-017 will provide benefits. The staff have

assessed these benefits in Table 5.

Table 5 Assessment of benefits of RF-017

Description of

benefit

Likelihood Magnitude Matrix Comment Effect

level

RF-017 provides an

alternative means

of delivering an

active ingredient to

a surface from the

traditionally used

water based

sprays.

Likely Minimal Low The staff consider a low level of

benefit to be derived from the use and

availability of RF-017.

Low

The availability of

RF-017 will provide

greater choice to

consumers.




Low

The use of RF-017

instead of water

based sprays will

reduce the number

of reapplications

required lowering

applicators

exposure to

deltamethrin.




Low

3.14. The staff consider there is an overall low level of benefits to be gained throughout the lifecycle

of RF-017.

Relationship of Māori to the Environment

3.15. The staff note that the substance triggers a number of hazardous properties giving rise to the

potential for cultural risk. However, based on the information provided, the staff consider that

the risks will be negligible. The rationale for this approach is outlined in the Supplementary

Information (section 3).

4. Setting controls

Variations to Default Controls

4.1. As a result of the risk assessment, the staff consider that variations should be made to the

default controls. These variations are summarised in Table 6 below. A full description of the

rationale for these variations is documented in Appendix 3.

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Table 6 Proposed variations to the default controls for RF-017.

Control

Code

Subject matter Proposed Variation Comment

T1 Limiting exposure

to toxic substances

through the setting

of TELs

No ADEs, PDEs or TELs are set for

any components of RF-017 at this

time.

The staff are intending to review the

setting of TELs under section 77B

of the Act, the staff propose not to

set ADEs, PDEs or TELS for any

components of RF-017 at this time

until this review is complete.

T2 Controlling

exposure to toxic

substances in

places of work

through the setting

of WESs

A WES value is set for component

D of RF-017.

The staff note that WES values

have been set for Components D, H

and K in RF-017. The WES value

for component H is not considered

relevant due to the physical form of

RF-017 and the WES value for

component K is not considered

relevant due to the low

concentration in the formulation.

The WES value for component D is

considered relevant to RF-017 and

it is proposed that these are

adopted as HSNO WES values.

Please refer:

http://www.osh.dol.govt.nz/publicati

ons/booklets/wes-jul-2011/wes-jul-

2011.pdf

E1 Limiting exposure

to ecotoxic

substances though

the setting of EELs

No EEL values are set at this time

and the default EELs are deleted.

Until the staff have developed

formal policy on the implementation

of section 77B, it is proposed that

the default EEL water and soil

values be deleted.

E2 Restrictions on use

of substances in

application areas

No maximum application rate has

been set.

As no EELs have been proposed,

no application rate is required to be

set under this control at this time.

E7/AH1 Approved Handler

requirements

This control is deleted. These controls were triggered by

the ecotoxicity classifications of RF-

017. The staff consider these

controls should be deleted as the

use pattern of this product is not

considered widely dispersive and

environmental exposure is not

expected through use of this

product.

TR1 Tracking

requirement during

use of the

substance

Deleted. It is considered that the risks that

may arise during the substance‘s

lifecycle will adequately be

managed by other controls such as

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packaging, labelling and emergency

management requirements and

therefore the tracking requirements

can be deleted.

Proposed additional controls

4.2. As a result of its assessment of the human health risks associated with the use of RF-017, the

staff consider that the following additional controls should be added:

Label statements

4.3. The label must include statements, to the following effect:

Prolonged exposure to this substance may result in nerve damage;

The addition of this substance to surface coatings shall be carried out in well ventilated

areas;

Where surface coatings containing this substance have been applied the area must

remain well ventilated until the surface coating is dry; and

The substance shall be used within five hours of addition to surface coatings.

4.4. When RF-017 is available for commercial use the label includes the statements:

Prolonged exposure to the substance must be avoided; and

A person must not use the substance on more than 14 days in any 30 day period.

Use restrictions

4.5. A person who uses the substance must comply with the following:

The substance shall not be applied onto or into water;

The substance shall be applied by non-spray application methods only;

The substance shall only be used as an additive to surface coatings.

4.6. A person who uses the substance in a commercial environment must comply with the

following:


Packaging restriction

4.7. A person who imports or manufactures the substance for non-commercial use must ensure

that the available pack size is no larger than 52mL, to be added to 4L of surface coatings.

Secondary containment

4.8. Control EM12 relates to the requirements for secondary containment of pooling substances.

The EM12 secondary containment requirements have been triggered for RF-017 as a result of

the 6.1D and 9.1A classifications. Also, the staff consider that the risks associated with the

containment of substances which are not class 1 to 5 substances (i.e. do not ignite or explode)

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are different to those associated with class 1 to 5 substances. Consequently, the staff consider

that the secondary containment requirements can be reduced and that these reduced

secondary containment measures are adequate to manage the risks of a spillage of RF-017.

Therefore, the proposed additional control, which varies the EM12 control, is more cost-

effective in terms of managing the risks of the substance. The proposed controls are shown in

Table A4.1 of Appendix 4.

4.9. The proposed controls are shown in Table A4.1 of Appendix 4.

5. Approach to risk

5.1. In considering its approach to the non-negligible risks to the human health of frequent,

commercial users of RF-017 from target organ toxicity during the use of RF-017, the staff note

the following:

Exposure period

5.2. The exposure period identified for prolonged, repeated daily exposure is for no more than 2

weeks every month. The staff acknowledge there is some uncertainty around this number

which was derived from the quantitative risk assessment and using expert judgment.

Voluntary nature of exposure

5.3. Exposure to the identified risks is voluntary. The additional labelling control warning that

prolonged, repeated exposure may result in nerve damage will inform users of the chronic risk

to human health from prolonged use.

Additional controls to reduce operator exposure

5.4. The staff are proposing stringent additional controls to reduce user exposure to RF-017 during

use such as:

RF-017 shall be applied by non-spray application methods only;

A warning stating ‗Prolonged exposure to RF-017 may result in nerve damage‘ shall be

included on the label;

The addition of RF-017 to surface coatings and the application of surface coatings shall

be carried out in well ventilated areas. A statement to this affect shall be included on the

label; and

The product shall be used within five hours of addition to surface coatings. Advice to this

effect shall be included on the label.

5.5. Taking these matters into account, the staff do not consider that the Authority needs to take a

cautious and risk adverse approach to the assessment of the risk cost and benefits associated

with RF-017.

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6. Overall evaluation and recommendation

6.1. The staff‘s risk assessment indicates that:

there is a low level of risk to operators using RF-017; and

there are three low benefits to be gained from the availability RF-017.

6.2. The staff have proposed additional controls to mitigate the risk to operators and considers that,

with these controls in place, and noting that operators will be aware of the risks involved, the

overall level of benefit provided by the availability of RF-017 outweighs the low level of risk that

occurs to operators. Therefore, the staff consider that the application may be approved in

accordance with clause 27, with the controls documented in Appendix 4.

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Appendix 1: Classification of RF-017

Data from effects testing of the formulation were not provided for any hazard endpoint for RF-017 so

classification was estimated using information on the effects of the components and mixture rules.

The relevant sections of the User Guide to Thresholds and Classifications under the HSNO Act

(ERMA 2008a) that describe the mixture rules are listed in Table A1.1. Classifications of the

formulation are shown in Table A1.2.

Table A1.1: Location of mixture rules within the User Guide to the Thresholds and Classifications in the

HSNO Act (V2.0. March 2008) (ERMA 2008a).

Hazard User Guide to HSNO

Thresholds and

Classifications Reference

Subclass 6.1 Acute Toxicity Part V, Chapter 10, Page 12

Subclass 6.3/8.2 Skin Irritancy/Corrosivity Part V, Chapter 11, Page 7

Subclass 6.4/8.3 Eye Irritancy/Corrosivity Part V, Chapter 12, Page 9

Subclass 6.5 Contact and Respiratory Sensitisation Part V, Chapter 13, Page 8

Subclass 6.6 Mutagenicity Part V, Chapter 14, Page 5

Subclass 6.7 Carcinogenicity Part V, Chapter 15, Page 8

Subclass 6.8 Reproductive Developmental Toxicity Part V, Chapter 16, Page 11

Subclass 6.9 Target Organ Systemic Toxicity Part V, Chapter 17, Page 10

Subclass 9.1 Aquatic Ecotoxicity Part VI, Chapter 19, Page 18

Subclass 9.2 Soil Ecotoxicity Part VI, Chapter 20, Page 8

Subclass 9.3 Terrestrial Vertebrate Ecotoxicity Part VI, Chapter 21, Page 7

Subclass 9.4 Terrestrial Invertebrate Ecotoxicity Part VI, Chapter 22, Page 5

Table A1.2: Classification of RF-017

Hazardous Property Applicant’s

Assessment

Staff

Assessment

Driver of

Classification

Acute toxicity (oral) 6.1D 6.1D Mixture rules

Components A, B, E,

F, and K

Skin irritancy 6.3B** -- Mixture rules

Eye irritancy 6.4A 6.4A Mixture rules

Components A, E, F,

J, K, L and O

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Target organ toxicity -- 6.9B Mixture rules

Component A

Aquatic ecotoxicity 9.1A 9.1A Mixture rules

(Component A)

Ecotoxicity to terrestrial vertebrates 9.3B 9.3B Mixture rules

(Component A)

Ecotoxicity to terrestrial invertebrates 9.4A 9.4A Mixture rules

(Component A)

** Presumed rounding error in applicant‘s calculation

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Appendix 2: Risk Assessment

Use Pattern

RF-017 will be used by combining with coatings just prior to application. This provides the coated

surface with insect resistance, while having benefits of the active ingredient bound in a film.

When diluted in a coating for application, the concentration of active ingredient is approximately the

same as RTU (Ready to Use) trigger packs containing deltamethrin which are available for sale to

and used by the general public.

RF-017 provides an alternative means of delivering deltamethrin onto a surface from the traditionally

used water based sprays. Since deltamethrin is bound in a paint film, it potentially reduces the

number of reapplications of the active ingredient required to produce an equivalent level of

effectiveness.

The substance does not contain any Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent

and Very Bioaccumulative (VPVB) Substances, components, contaminants or metabolites

Risk Assessment

The methodology involved in assessing risk is outlined in the Supplementary Information section.

Quantitative human health risk assessment has been undertaken for the use phase of the

substance‘s lifecycle.

Qualitative assessments have been undertaken for all other phases of substance‘s lifecycle. In these

cases, the level of risk has been evaluated on the basis of the magnitude and likelihood of adverse

effects occurring to people or the environment.

The staff did not identify any risks associated with society and the community, the market economy or

New Zealand‘s international obligations.

Relationship of Māori to the environment

The staff have considered this application in accordance with the clauses 9(b)(i) and 9(c)(iv) and

sections 6(d) and 8. In addition, the framework contained in the ERMA New Zealand user guide

―Working with Māori under the HSNO Act 1996‖ has been used to assess the effects of this

application on the relationship of Māori to the environment.

The staff note that RF-017 triggers a number of hazardous properties giving rise to the potential for

cultural risk including the deterioration of the mauri of taonga flora and fauna species, the

environment and the general health and well-being of individuals and the community.

In addition, the introduction and use of this substance has the potential to inhibit the ability of

iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of waterways given

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the highly ecotoxic nature of the substance to aquatic species, and potential risks to the mauri ora of

human health under prolonged exposure to this substance.

On considering the information outlined here and elsewhere in this report, the staff consider a minimal

impact from RF-017 on the relationship of Māori and their culture and traditions with their ancestral

lands, water, sites, wāhi tapu, valued flora and fauna and other taonga to be improbable. In addition

there is no evidence to suggest that the controlled use of RF-017 will breach the principles of the

Treaty of Waitangi.

The overall level of risk is therefore considered to be negligible for RF-017 and assuming that the

substance will be handled, stored, transported, used, and disposed of, in accordance with the

explicitly stated default and additional controls proposed in this report, and any other controls required

by other legislation.

However, the staff note that should inappropriate use, or accident, result in the contamination of

waterways or the environment generally, that users notify the appropriate authorities including the

relevant iwi authorities in that region. This action should include advising them of the contamination

and the measures taken to contain and remediate.

Human health risk assessment

Operator exposure assessment

Deriving the AOEL for Deltamethrin

Selection of the NOAEL: The study selected was a 13 week repeat-dose oral toxicity study in dogs.

The primary toxic signs observed were characteristic of agents that disrupt the autonomic nervous

system and many of these signs were consistent with the neurotoxicity associated with pyrethroids.

These signs included: excessive salivation, decreased activity, labored breathing, gasping, impaired

limb function, ataxia, and loss of righting reflex, tremors, reduction of patellar and flexor reflexes,

convulsions, liquid feces, vomiting, and lethality. The NOAEL for this study was 0.1 mg/kg/day (the

lowest dose tested) (Chesterman, 1977). Significant, long-lived, peripheral nerve damage has been

detected in rodents and dogs (NOAEL = 1 mg/kg/day) following exposure durations as short as 5

weeks (Chesterman, 1977) The staff regard the NOAEL for significant effects to be 0.1 mg/kg/day.

Uncertainty factors: The following uncertainty factors were used:

10 for interspecies extrapolation;

10 for intraspecies variation;

Thus a combined uncertainty factor of 100 (10 x 10) was used.

Determination of oral absorption fraction: An oral absorption fraction of 0.6 was used for this

assessment. This is based upon the results of the California Environmental Protection Agency risk

assessment for deltamethrin.

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Calculation of the AOEL:

(systemic)bw/day mg/kg 0.0006 0.6 x 100

0.1

bw/day mg/kg Factor Absorption Oral x UF

N(L)OAEL AOEL

The staff are aware that the above AOEL is significantly lower than the current EU AOEL. However,

the staff also note that the EU did not take into account the peripheral nerve histopathology findings.

While such findings may not be relevant for a single or occasional use of a deltamethrin RTU

formulation, they are of significant concern for persons who will be applying the substance repeatedly

over time. Combined with this is that the exposure modelling performed (see below) has a default

assumption that a person will spend 2.2 hours per day applying the paint, which is not considered

conservative.

The data that supports the NOAEL used by the staff to calculate the AOEL is as follows (Frank &

Kellner, 2000):

Table A2.1: Clinical signs reported in dogs during the first week of a 13-week deltamethrin exposure study:

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Table A2.2: Clinical signs reported in dogs during weeks 5 and 12 of a 13-week study:

Table A2.3: Non-neoplastic microscopic lesions reported at the 18 month interim sacrifice of a 24-month

combined toxicity/oncogenicity study conducted in rats:

To summarise the data on the peripheral nerve degeneration:

The effect has been demonstrated to occur across species (rodents and dogs);

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There is no clear evidence (mechanistic or epidemiological) to conclude that the effect

does not occur in humans;

The NOAEL for the effect in both species is 0.1 mg/kg BW/day;

The effect has been noted in the sciatic, tibial and plantar nerves i.e. it affects several

significant peripheral nerves and is not localized to one nerve;

o The tibial nerve appears to be particularly sensitive to the effect;

The damage to the nerves has effects on motor function in both species (as evidenced by

changes in motor reflexes) and are thus functionally significant;

The effects on the peripheral nerves is clearly dose-related;

The effects on the peripheral nerves is statistically significant in both dogs and rodents at

the LOAEL;

The peripheral nerve effects are present, depending on which nerve is examined, after

about 5 weeks of dosing and persist at least into the geriatric life stage. This would

encompass the bulk of a normal working lifespan of a human;

There is some possibility of a very slowly developing tolerance i.e. when rodents reach

the end of their lifespan (2 years), the effect is no longer present, however the effect is

still present at the geriatric life stage (i.e. 18 months of age). However, the more

plausible explanation is that the background incidence of peripheral nerve damage

increases with age in rodents and this increase control animals simply masked any

response attributable to deltamethrin. Thus animals exposed to deltamethrin will develop

peripheral nerve damage that is equivalent to that observed in geriatric animals by about

5 weeks of age.

Assessment of External (i.e. Non-Internalized or Non-Systemic) Exposure to Deltamethrin During the

Application of RF-017-Containing Paint

The ECETOC TRA consumer model is able to assess exposure to paint components during the

surface coating application process. Accordingly, this model has been used to assess the operator‘s

(i.e. painter‘s) exposure to deltamethrin once RF-017 has been mixed into 2 types of paint: (a)

waterborne latex wall paint; and (b) solvent rich, high solid, waterborne paint [typically referred to by

users as an ―oil based paint‖.

The following parameters were used in the exposure modelling:

Both non-spray application methods (application by brush or roller techniques only) and

spray application techniques are used;

Vapor pressure of deltamethrin = 2 x 10-8

25OC (Extoxnet, 1995);

No oral exposure occurs. Exposure is assumed to only occur via the dermal and

inhalation routes (default value in the model for paints and coatings);

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Skin surface contact area with the paint of 2% of total body surface area (default value in

the model). This is equivalent to slightly more tha7n the palmar surface of one hand

(palmar surface of one hand is 1.5% of total body surface area, the palmar plus dorsal

surface of one hand is approximately 2.5% of total body surface area (Wedro, 2009));

Typical mass of 1L of waterborne latex wall paint = 1018.52 g (approximately 8.516

lb/gallon (Material Safety Data Sheet – Latex Vapour Barrier Primer, 2004));

Typical mass of 1 L of solvent rich, high solid, waterborne paint = 1018.52 g

(approximately 8.516 lb/gallon ((2004). Material Safety Data Sheet – Elite oil satin house

paint);

Fraction of deltamethrin in paints = 0.63 g deltamethrin/L of paint = 0.63 g/1018.52 g =

6.185 x 10-4

;

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Table A2.4: Input Parameters for modelling

Default Route of

Relevance

Adult

Child

Dermal Exposure Inhalation Derm/Oral All

Derm

al

Ora

l

Inh

ala

tio

n

Bo

dy

Pa

rt

Co

ns

ide

red

Ad

ult

Co

nta

ct

Are

a (

cm

2)

Ch

ild

Co

nta

ct

Are

a (

cm

2)

Am

ou

nt

of

pro

du

ct

for

form

ula

(g/e

ve

nt)

Ex

po

su

re

Tim

e (

hr)

Th

ick

ne

ss

La

ye

r (c

m)

Den

sit

y

(g/c

m3)

Fre

Q o

f U

se

(ev

en

ts/d

ay

)

PC9a:

Coatings

, paints,

thinners,

remover

s

Waterborne

latex wall

paint

y n y 2: inside

hands /

one hand /

palm of

hands

428.75 N/A 3750 2.2 0.01 1 1

Solvent rich,

high solid,

waterborne

paint

y n y 2: inside

hands /

one hand /

palm of

hands

428.75 N/A 1300 2.2 0.01 1 1

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Table A2.5: Modelling results for non-spray application (external, or non-systemic exposure levels):

Descriptor Product

Subcategory

Dermal

Exposure

Estimate

(mg/kg/day)

Inhalation

Exposure

Estimate

(mg/kg/day)

Inhalation

Exposure

Estimate

(mg/m3)

Total Exposure

(mg/kg/day)

PC9a:

Coatings,

paints,

thinners,

removers

Waterborne

latex wall paint

0.0442 0.0058 0.1160 0.0500

Solvent rich,

high solid, water

borne paint

0.0442 0.0020

0.0402 0.0462

Table A2.6: Modelling results for spray application (external, or non-systemic exposure levels):

Descriptor Product

Subcategory

Dermal

Exposure

Estimate

(mg/kg/day)

Inhalation

Exposure

Estimate

(mg/kg/day)

Inhalation

Exposure

Estimate

(mg/m3)

Total Exposure

(mg/kg/day)

PC9a:

Coatings,

paints,

thinners,

removers

Waterborne

latex wall paint

0.0442 5.8290 115.9688 5.8732

Solvent rich,

high solid, water

borne paint

0.0442 2.0207

40.2025 2.0649

Assessment of Internal (Systemic) Exposure to Deltamethrin during the application of RF-017-

Containing Paint

Estimation of respiratory absorption fraction: in the absence of available data, the respiratory

absorption fraction is assumed to be 1 (i.e. 100% absorption through the respiratory tract).

Estimation of the dermal absorption fraction: Based upon the evaluation by the California EPA, the

adjusted dermal absorption values for deltamethrin were 6.8% and 6.5% for the low and medium

dose, respectively. An average value of 6.7% was used in the estimation of an absorbed dose for

dermal exposure. Accordingly, the dermal absorption factor is 0.067.

Calculation of the internal (systemic) exposure to deltamethrin:

factor protection PPEx exposure yrespirator externalx factor absorption yrespirator

factor protection PPEx exposure dermal externalx factor absorption dermal Exposure (Systemic) Internal

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Table A2.7: Non-spray application calculation inputs

Paint Type External

Dermal

Exposure

Estimate

External

Inhalation

Exposure

Estimate

Respiratory

Absorption

Fraction

Dermal

Absorption

Fraction

PPE protection

factors

Waterborne

latex wall

paint

0.0442 mg/kg

bw

0.0058

mg/kg bw

1 0.067 Dermal = 1 (no PPE)

Respiratory = 1 (no

PPE)

Waterborne

latex wall

paint

0.0442 mg/kg

bw

0.0058

mg/kg bw

1 0.067 Dermal = 0.16 (nitrile

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

Respiratory = 1 (no

PPE)

Waterborne

latex wall

paint

0.0442 mg/kg

bw

0.0058

mg/kg bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

Respiratory = 1 (no

PPE)

Waterborne

latex wall

paint

0.0442 mg/kg

bw

0.0058

mg/kg bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

Respiratory = 0.1 (i.e.

90% effective)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

0.002 mg/kg

bw


Respiratory = 1 (no

PPE)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

0.002 mg/kg

bw


gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

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Respiratory = 1 (no

PPE)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

0.002 mg/kg

bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

Respiratory = 1 (no

PPE)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

0.002 mg/kg

bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)


90% effective)

Table A2.8: Spray application calculation inputs

Paint Type External

Dermal

Exposure

Estimate

External

Inhalation

Exposure

Estimate

Respiratory

Absorption

Fraction

Dermal

Absorption

Fraction

PPE protection

factors

Waterborne

latex wall

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw


Respiratory = 1 (no

PPE)

Waterborne

latex wall

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw


gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

Respiratory = 1 (no

PPE)

Waterborne

latex wall

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

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Respiratory = 1 (no

PPE)

Waterborne

latex wall

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)


90% effective)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw


Respiratory = 1 (no

PPE)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw


gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

Respiratory = 1 (no

PPE)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)

Respiratory = 1 (no

PPE)

Solvent rich,

high solid,

waterborne

paint

0.0442 mg/kg

bw

5.829 mg/kg

bw

1 0.067 Dermal = 0.09 (viton

gloves, 2.2 hour

exposure ) (Cherie,

Semple et Brouwer,

2004)


90% effective)

Calculation of the Risk Quotients

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AOEL

Exposure Quotient Risk

Table A2.9: Calculation of risk quotients

Use Type Internal (Systemic Dose) AOEL Risk Quotient

(= Exposure / AOEL)

Non-spray application,

waterborne latex wall paint,

no PPE

0.009 mg/kg bw per single

daily application over a

period of 2.2 hours

0.0006 mg/kg

bw

15



nitrile gloves only



period of 2.2 hours

0.0006 mg/kg

bw

10



viton gloves only



period of 2.2 hours

0.0006 mg/kg

bw

10



viton gloves plus 90%

effective respiratory

protection



period of 2.2 hours

0.0006 mg/kg

bw

1.3


solvent rich, high solid,

waterborne paint, no PPE



period of 2.2 hours

0.0006 mg/kg

bw

8.3



waterborne paint, nitrile

gloves only



period of 2.2 hours

0.0006 mg/kg

bw

3.3



waterborne paint, viton

gloves only



period of 2.2 hours

0.0006 mg/kg

bw

3.3



waterborne paint, viton

gloves plus 90% effective

respiratory protection

0.0026mg/kg bw per single


period of 2.2 hours

0.0006 mg/kg

bw

4.3

Spray application,


no PPE



period of 2.2 hours

0.0006 mg/kg

bw

9717

Spray application,


nitrile gloves only



period of 2.2 hours

0.0006 mg/kg

bw

9717

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Spray application,


viton gloves only



period of 2.2 hours

0.0006 mg/kg

bw

9717

Spray application,


viton gloves + 90% effective

respiratory protection



period of 2.2 hours

0.0006 mg/kg

bw

966

Spray application, solvent

rich, high solid, waterborne

paint, no PPE



period of 2.2 hours

0.0006 mg/kg

bw

9717



paint, nitrile gloves only



period of 2.2 hours

0.0006 mg/kg

bw

9717



paint, viton gloves only



period of 2.2 hours

0.0006 mg/kg

bw

9717



paint, viton gloves plus 90%

effective respiratory

protection



period of 2.2 hours

0.0006 mg/kg

bw

966

In all situations modeled, the RQs due to deltamethrin exposure during the application of RF-017-

containing paint are substantially higher than 1. Even with the combined use of chemical resistant

(viton) glove and 90% effective respiratory protection, the RQ values still exceed 1. It should be

clearly noted that the concept of 90% effective respiratory protection is an entirely theoretical one

which has been used in the modelling in order to obtain the lowest theoretically possible RQ value

under the circumstances of the application of RF-017-containing paint. The only way that 90%

effective respiratory protection can be obtained in practice is by using a 100% closed system for the

application of RF-017-containing paint.

It should be noted that exposure modelling is not conservative and the following should be noted:

The modelling assumes a potential skin contact area with the paint of 2% of total body

surface area. This is equivalent to slightly more than the palmar surface of one hand and

is equivalent to a person wearing a long-sleeved shirt, long pants, shoes, socks, and if

the paint is being applied over head, a hat;

The model assumes 1 single application of the product lasting no more than 2.2 hours

per day. An increased number of application times or a longer time spent applying the

paint will substantially increase the RQ values;

The staff have no method for accurately assessing the risk of mixing RF-017 with paint. However, the

use of PPE (gloves, long sleeved shirt, long pants, shoes and socks) is suggested given the

significant contribution of dermal exposure to the RQ values discussed above.

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Likewise, the staff have no method of accurately assessing the risk associated with dried surface

coatings that contain RF-017. It is suggested that this product should not be used in paints applied to

food preparation surfaces.

Environmental exposure and risk assessment

The use pattern of the product it is not considered wide dispersive and environmental exposure is not

expected through any route other than spillage and/or disposal of the containers. Therefore, neither

environmental exposure modelling has been performed nor environmental risks have been assessed.

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Appendix 3: Controls for RF-017 and their variations.

Based on the hazard classification as shown in Table A3.1, the set of associated controls has been

identified. These default controls, expressed as control codes2, are listed in Table A3.1. The staff

note that control E4 (control for vertebrate poisons) has been triggered for RF-017 on the basis of its

intrinsic hazard. However, this control was not considered relevant based on the substance‘s

lifecycle use and has therefore not been listed.

Table A3.1: List of default controls for RF-017

HSNO

Classification

HSNO Controls

6.1D

6.4A

6.9B

9.1A

9.3B

9.4A

Toxic

T1, T2, T4, T5, T7

Ecotoxic

E1, E2, E3, E5, E6, E7

Identification

I1, I3, I8, I9, I11, I16, I17, I18, I19, I20, I21, I23, I28, I29, I30

Packaging

P1, P3, P13, P15, PG3, PS4

Disposal

D4, D5, D6, D7, D8

Emergency Management

EM1, EM6, EM7, EM8, EM11, EM12, EM13

Tank Wagons and Transportable Containers

Personnel Qualifications

Tracking

TR1

Approved handler

AH1

The Authority is able to vary the default controls and impose controls under sections 77 and 77A to

produce a set of controls relevant to substance under assessment. The following discussion reviews

the default controls and rationalises their use for this substance.

2 Control codes are those assigned by ERMA NZ to enable easy cross reference with the regulations. A

detailed list of these codes is contained in the Supplementary Information (section 2).

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Toxicity Controls

Setting of TELs (Control Code T1)

With respect to setting TELs for other exposure routes, the staff are intending to review the setting of

ADEs, PDEs and TELs under section 77B of the Act. Until this review is complete, the staff propose

not to set ADEs, PDEs or TELS for any components of RF-017 at this time.

Setting of WES (Control Code T2)

When setting WES, the Authority must either adopt a value already proposed by the Department of

Labour or already set under HSNO or derive a value by taking into account the matters described in

Regulation 30(2) of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations.

The staff typically adopt WES values listed in the Workplace Exposure Standards (Effective from

2002) document (refer to the link below).

http://www.osh.dol.govt.nz/publications/booklets/wes-jul-2011/wes-jul-2011.pdf

The staff note that at this time Department of Labour WES values have been set for components D, H

and K. The WES value for component H is not considered relevant due to the physical form of the

product and the WES value of component K is not considered relevant due to the low concentration

of this component in RF-017. The WES value for component D is considered relevant to RF-017.

Requirements for protective clothing and equipment (Control code T5)

Regulation 8(1)(a) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001

states that –

(1) A person who handles a class 6.1A, 6.1B, 6.1C, 6.1D, 6.3A, 6.5A, 6.5B, 6.6A, 6.6B, 6.7A,

6.7B, 6.8A, 6.8B, 6.8C, 6.9A, 6.9B, 8.2A, 8.2C, or 8.3A substance must use protective

clothing or equipment that is designed, constructed, and operated to ensure that the

person—

(a) does not come into contact with the substance; and …

The staff recommend that applicators applying surface coatings containing RF-017 wear gloves. The

staff consider this to be good practice for the application of surface coatings.

Ecotoxicity Controls

Setting of EELs (Control code E1)

The Hazardous Substances and New Organisms (Approvals and Enforcement) Act 2005 added a

new section (s77B) to the HSNO Act, which, amongst other things provided the Authority with the

ability to set EELs as guideline values, rather than the previous pass/fail values.

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However, until the staff have developed formal policy on the implementation of s77B, it proposes not

to set EELs for any components of RF-017 at this time. It is also proposed that the default EEL water

and soil values be deleted until the policy has been established.

Setting of Application Rate (Control Code E2)

These regulations relate to the requirement to set an application rate for a class 9 substance that is to

be sprayed or applied to an area of land (or air or water) and for which an EEL has been set.

As no EELs have been proposed, no application rate is required to be set under this control at this

time.

Identification controls

Identification of Toxic Components on Labels/Documentation (SDS)

Concentration cut-offs for component identification

Consistent with the guidance provided by GHS, the Hazardous Substances Standing Committee

(HSSC) agreed that the concentration cut-offs triggering the requirement for identification of

components on labels and documentation are:

HSNO Classification Cut-off for label (% w/w) Cut-off for SDS (% w/w)

6.1A, B, C, D, 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

RF-017 - Components requiring identification

Under these regulations, as determined by the HSSC (March 2006), the name and concentration of

the following components need to be specified on the label and documentation:

Label Documentation

Deltamethrin Deltamethrin

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Additional controls under section 77 A

The staff consider that by adding the following labelling controls to this substance that users will be

more aware of the risk around the use of this substance and how to use it appropriately. The following

controls are proposed to be added under section 77A(4)(c) of the Act.

The label must include statements, to the following effect:



areas;




A person who sells the substance for commercial use must ensure that the label includes the

statements:



The staff consider the following use controls are more effective in managing the risks to human health

from the use of this substance. The following controls are proposed to be added under section

77A(4)(a) of the Act as they will be more effective in terms of its effect on the management, use, and

risks of the substance.

A person who uses the substance must comply with the following:


The substance shall be applied by non-spray application methods only;

The substance shall only be used as an additive to surface coatings;


areas;




A person who uses the substance in a commercial environment must comply with the following


A person who sells the substance to for non commercial use must ensure that

A pack size of no larger than 52mL (to be added to 4L of surface coatings) is available.

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Appendix 4: Proposed controls for RF-017

Table A4.1: Proposed controls for RF-017 codes, regulations and variations.

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001

Code Regulation Description Variation

T1 Regs 11 – 27 Limiting exposure to

toxic substances

through the setting of

TELs

No ADEs, PDEs or

TELs are set for this

substance at this time.

T2 Regs 29, 30 Controlling exposure in

places of work through

the setting of WESs.

A WES value is set for

component D. Please

refer:

http://www.osh.dol.govt.

nz/publications/booklets

/wes-jul-2011/wes-jul-

2011.pdf

T4 Reg 7 Requirements for

equipment used to

handle substances

T5 Reg 8 Requirements for

protective clothing and

equipment

T7 Reg 10 Restrictions on the

carriage of toxic or

corrosive substances on

passenger service

vehicles

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001


E1 Regs 32 – 45 Limiting exposure to

ecotoxic substances

through the setting of

EELs

No EELs are set for

this substance at this

time and the default

EELs are deleted.

E2 Regs 46 – 48 Restrictions on use of

substances in

application areas

No application rate is

set at this time.

E3 Reg 49 Controls relating to

protection of terrestrial

invertebrates eg

beneficial insects

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E5 Regs 5(2), 6 Requirements for

keeping records of use

E6 Reg 7 Requirements for

equipment used to

handle substances

Hazardous Substances (Identification) Regulations 2001


I1 Regs 6, 7, 32 – 35,

36(1) – (7)

Identification

requirements, duties of

persons in charge,

accessibility,

comprehensibility, clarity

and durability

I3 Reg 9 Priority identifiers for

ecotoxic substances

I8 Reg 14 Priority identifiers for

toxic substances

I9 Reg 18 Secondary identifiers for

all hazardous

substances


ecotoxic substances


toxic substances

I17 Reg 26 Use of generic names

I18 Reg 27 Requirements for using

concentration ranges

I19 Regs 29 – 31 Additional information

requirements, including

situations where

substances are in

multiple packaging

I20 Reg 36(8) Durability of information

for class 6.1 substances

I21 Regs 37 – 39, 47 – 50 General documentation

requirements

I23 Reg 41 Specific documentation

requirements for

ecotoxic substances

I28 Reg 46 Specific documentation

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requirements for toxic

substances

I29 Regs 51, 52 Signage requirements

I30 Reg 53 Advertising corrosive

and toxic substances

Hazardous Substances (Packaging) Regulations 2001


P1 Regs 5, 6, 7(1), 8 General packaging

requirements

P3 Reg 9 Criteria that allow

substances to be

packaged to a standard

not meeting Packing

Group I, II or III criteria

P13 Reg 19 Packaging requirements

for toxic substances

P15 Reg 21 Packaging requirements

for ecotoxic substances

PG3 Schedule 3 Packaging requirements

equivalent to UN

Packing Group III

PS4 Schedule 4 Packaging requirements

as specified in Schedule

4

Hazardous Substances (Disposal) Regulations 2001


D4 Reg 8 Disposal requirements

for toxic and corrosive

substances


for ecotoxic substances


for packages

D7 Regs 11, 12 Information

requirements for

manufacturers,

importers and suppliers,

and persons in charge

D8 Regs 13, 14 Documentation

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requirements for

manufacturers,

importers and suppliers,

and persons in charge

Hazardous Substances (Emergency Management) Regulations 2001


EM1 Regs 6, 7, 9 – 11 Level 1 information

requirements for

suppliers and persons in

charge

EM6 Reg 8(e) Information

requirements for toxic

substances

EM7 Reg 8(f) Information

requirements for

ecotoxic substances

EM8 Regs 12 – 16, 18 – 20 Level 2 information

requirements for

suppliers and persons in

charge

EM11 Regs 25 – 34 Level 3 emergency

management

requirements: duties of

person in charge,

emergency response

plans

EM12 Regs 35 – 41 Level 3 emergency

management

requirements:

secondary containment

The control imposed by regulation 36 is varied by the addition of the following

words subclause (3):

(4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it— (a) is not to be taken into account in determining whether a place is

required to have a secondary containment system; and (b) is not required to be located in a secondary containment system.

(5) In this clause, pipework—

(a) means piping that—

(i) is connected to a stationary container; and

(ii) is used to transfer a hazardous substance into or out of the

stationary container; and

(b) includes a process pipeline or a transfer line.

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The control imposed by regulation 37 is varied by substituting the following

words:

(1) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in containers each of which has a capacity of 60 litres or less— (a) if the place’s total pooling potential is less than 20,000 litres, the

secondary containment system must have a capacity of at least 25% of that total pooling potential:

(b) if the place’s total pooling potential is 20,000 litres or more, the secondary containment system must have a capacity of the greater of—

(i) 5% of the total pooling potential; or

(ii) 5,000 litres.

(2) Pooling substances to which subclause (1) applies must be segregated where appropriate to ensure that leakage of one substance may not adversely affect the container of another substance.

The control imposed by regulation 38 is varied by substituting the following

words:

(1) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in containers 1 or more of which have a capacity of more than 60 litres but none of which have a capacity of more than 450 litres— (a) if the place’s total pooling potential is less than 20,000 litres, the

secondary containment system must have a capacity of either 25% of that total pooling potential or 110% of the capacity of the largest container, whichever is the greater:

(b) if the place’s total pooling potential is 20,000 litres or more, the secondary containment system must have a capacity of the greater of—

(i) 5% of the total pooling potential; or

(ii) 5,000 litres

(2) Pooling substances to which subclause (1) applies must be segregated where appropriate to ensure that the leakage of one substance may not adversely affect the container of another substance

EM13 Reg 42 Level 3 emergency

management

requirements: signage

Hazardous Substances (Tank Wagon and Transportable Containers) Regulations

2004


Tank Wagon Regs 4 to 43 as

applicable

Controls relating to tank

wagons and

transportable

containers.

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Additional controls under section 77A

Control title Description

Labelling controls The label must include statements, to the following effect, on the label:


The addition of this substance to surface coatings shall be carried out

in well ventilated areas;

Where surface coatings containing this substance have been applied

the area must remain well ventilated until the surface coating is dry;

and

The substance shall be used within five hours of addition to surface

coatings.

A person who imports or manufactures the substance for commercial use must

ensure that the label includes the statements:


A person must not use the substance on more than 14 days in any 30

day period.

Use Controls A person who uses the substance must comply with the following:


The substance shall be applied by non-spray application methods

only;

The substance shall only be used as an additive to surface coatings;

Non commercial use

control

A person who imports or manufactures the substance for non commercial use

must ensure that

A pack size of no larger than 52mL (to be added to 4L of surface

coatings) is available.

Schedule 8 The controls relating to stationary container systems as set out in Schedule 8,

Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)

Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26 March

2004, No. 35, page 767), as amended, shall apply to this substance,

notwithstanding clause 1(1) of Schedule 8.

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Appendix 5: Parties notified

Aakland Chemicals (1997) Limited

AgBio Research Limited

Agcarm Incorporated

AgResearch Limited

AgResearch Limited

Agronica New Zealand Limited

AR and JA Drysdale Limited

ARPPA

Baldwins Intellectual Property

BASF New Zealand Limited

Bayer New Zealand Limited

BOC Limited

Carter Holt Harvey Woodproducts New Zealand

Chancery Green

Chemagro New Zealand Limited

Chemsafety Limited

Community and Public Health

Dow AgroSciences Australia Limited

DuPont (New Zealand) Limited

Environment Bay of Plenty

Environment Bay of Plenty

Environs Holdings Limited

Far North District Council

Farmoz Pty Ltd

Federated Farmers of New Zealand (Incorporated)

Fish and Game Eastern Region

Fruitfed Supplies Limited (PGG Wrightson Ltd)

Grayson Wagner Company Ltd

Greater Wellington - The Regional Council

Green Party of Aotearoa New Zealand

Hawkes Bay Regional Council

Hawkes Bay Regional Council

Haz-Subs Solutions Limited

IMCD New Zealand Limited

Kaipara District Council

Kawerau District Council

Landcorp Farming Limited

Lowndes Associates

MAF Biosecurity New Zealand - Wellington

Massey University

Merial New Zealand Limited

Ministry of Research Science and Technology (MoRST)

Napier Health Centre - Public Health Unit

National Beekeepers Association

New Zealand Bee Industry Group - Federated Farmers

New Zealand Chemical Industry Council Inc

New Zealand Customs Service

New Zealand Meatworkers Union

New Zealand Press Association

New Zealand Society of Gunsmiths Inc

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Ngāti Kahungunu Iwi Incorporated

Northland District Health Board

Northland Regional Council

Northland Regional Council

Nufarm Ltd

Nufarm Ltd

Pacific Growers Supplies Limited

Pesticide Action Network Aotearoa New Zealand

PharmVet Solutions

Physicians and Scientists for Global Responsibility (PSGR)

Rangitikei District Council

Reckitt Benckiser

Rentokil Initial Limited

Schering Plough Animal Health Limited

Sigma Aldrich

Sustainability Council of New Zealand

Syngenta Crop Protection Limited

Taranaki Regional Council

Tasman District Council

Taupo District Council

Technical Compliance Consultants Ltd

Television New Zealand

The Eden Park Trust

The National Beekeepers Association of New Zealand The New Zealand Institute for Plant and Food Research Limited (Auckland) The New Zealand Institute for Plant and Food Research Limited (Motueka)

The New Zealand Society for Risk Management Inc

TMP Consultancy

Trounson Park Road

Virbac New Zealand Limited

Zelam Limited

7 private individuals

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Appendix 6: References

Cherrie, J.W, Semple, S., Brouwer, D. (2004) Gloves and Dermal Exposure to Chemicals: Proposals for Evaluating Workplace Effectiveness. Ann. occup. Hyg., Vol. 48, No. 7, pp. 607–615. Chesterman, H. (1977) RU 22974 Oral Toxicity Study in Beagle Dogs. Huntingdon Research Centre (study submitted with application for registration of deltamethrin technical, AgrEvo Environmental Health, Inc., project Number RSL: 253/77251, DPR Document 51846-007 #129661. Frank JP, Kellner TP (2000) Deltamethrin Risk Characterization Document. Volume 1. Health Assessment Section Medical Toxicology Branch, Department Pesticide Regulation, California Environmental Protection Agency. http://www.cdpr.ca.gov/docs/risk/rcd/deltameth.pdf ERMA New Zealand (2008a) User Guide to HSNO Thresholds and Classifications. ERMA New Zealand, Wellington. ERMA New Zealand (2008b) HSNO Chemical Classification Information Database (CCID) http://www.ermanz.govt.nz/hs/compliance/chemicals.html European Union (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. http://reach.jrc.it/ Extoxnet (1995) Deltamethrin. Oregon State University http://extoxnet.orst.edu/pips/deltamet.htm Retrieved 24/11/2010. Klimisch, HJ, Andreae, E, Tillman, U (1997). A systematic approach for evaluating the quality of experimental and ecotoxicological data. Regulatory Toxicology and Pharmacology 25: 1–5. Urban DJ, Cook, NJ (1986) Hazard Evaluation Division Standard Evaluation Procedure: Ecological Risk Assessment. EPA 540/9-85-001. United States Environmental Protection Agency Office of Pesticide Programs, Washington DC, USA. Wedro, B. (2009). Burn Percentage in Adults: Rule of Nines. Emedicinehealth. http://www.emedicinehealth.com/burn_percentage_in_adults_rule_of_nines/article_em.html Retrieved 24/11/2010. (2004). Material Safety Data Sheet – Latex Vapour Barrier Primer. Graham Paint. http://www.grahampaint.com/msds/130-00%20MSDS.pdf Retrieved (24/11/2004) (2004). Material Safety Data Sheet – Elite oil satin house paint. Graham Paint. http://www.grahampaint.com/msds/130-00%20MSDS.pdf Retrieved (24/11/2004)

http://www.cdpr.ca.gov/docs/risk/rcd/deltameth.pdf

http://www.ermanz.govt.nz/hs/compliance/chemicals.html

http://reach.jrc.it/

http://extoxnet.orst.edu/pips/deltamet.htm%20Retrieved%2024/11/2010

http://extoxnet.orst.edu/pips/deltamet.htm%20Retrieved%2024/11/2010

http://www.emedicinehealth.com/burn_percentage_in_adults_rule_of_nines/article_em.html

http://www.grahampaint.com/msds/130-00%20MSDS.pdf

http://www.grahampaint.com/msds/130-00%20MSDS.pdf

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Appendix 7: Confidential material

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Supplementary Information

This document has been prepared to support the staff‘s Hazardous Substances Evaluation and

Review reports. It contains background information on five areas and has been divided into the

following sections:

The regulatory basis for assessing the application.

Legislation that will affect the use of hazardous substances within New Zealand. This

section covers the range of default controls available for use by the staff and lists other

legislation that will affect the use of hazardous substances.

Risk Assessment - The steps and methodology involved in assessment of effects.

Qualitative Descriptors for Risk/Benefit Assessment - the descriptors used to assess the

level of each risk or benefit to determine their level of significance.

Decision Pathway - to be used when assessing an application for the release of

hazardous substances.

Regulatory basis for assessing the application

The application was lodged pursuant to section 28 of the Hazardous Substances and New Organisms

Act 1996 (―the Act‖).

The Evaluation and Review report (―the E&R report‖) takes into account matters to be considered in

section 29; matters specified under Part 2 of the Act; and the relevant provisions of the Hazardous

Substances and New Organisms (Methodology) Order 1998 (―the Methodology‖). Unless otherwise

stated, references to section numbers in the report refer to sections of the Act and clauses to clauses

of the Methodology.

The Minister for the Environment was advised of the application under section 53(4)(a) and given the

opportunity to ―call-in‖ the application under section 68. This action was not initiated.

The Authority is able to vary the default controls and impose controls under sections 77 and 77A to

produce a set of controls relevant to the substance. Variations and additional controls for the

substance are considered in Section 5 of the E&R report.

In undertaking this assessment the staff have considered the Authority‘s approvals given to

substances under Part 5 of the Act as well as those transferred to the Act under the Hazardous

Substances (Pesticides) Transfer Notice 2004.

Section 96 provides that the Authority may identify and report to the Minister where it considers that a

reduction in the likely occurrence of adverse effects similar to that achieved by the controls attached

to any substance could be achieved by any environmental user charge, or a combination of an

environmental user charge and controls.

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The staff consider that use of controls is the most effective means of managing the risks throughout

the lifecycle of the substance being assessed. The imposition of an environmental user charge

instead of, or in combination with controls, is therefore not recommended under this approval.

Legislation that will affect the use of hazardous substances within New

Zealand

The HSNO legislation and other legislation, such as the Resource Management Act 1992 (―the RMA‖)

and the Health and Safety in Employment Act (―the HSE Act‖) provide for a number of controls that

are aimed at preventing exposure to hazardous substances, and/or mitigating any adverse effects

caused by such substances in the event of an accident, or a breach of controls. The key controls that

relate to the protection of human health and the environment during the various stages of the lifecycle

of hazardous substances are outlined in the sections below.

HSNO Legislation

The controls available to control a substances use under the HSNO legislation are determined by the

substances hazard classification and are comprehensively described in ERMA New Zealand‘s User

Guide to the Threshold and Classifications under the Hazardous Substances and New Organisms Act

1996. The following paragraphs describe the sorts of controls available and list those that are

available for use.

The Hazardous Substances (Identification) Regulations 2001 require that the hazardous properties of

substances be clearly identified on the label, as well as described in any documentation (Safety Data

Sheet) supplied with the substance. While the substance is being transported (including importation),

the regulations provide for bulk transport containers and/or any outer packaging to be labelled or

marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the

Maritime Safety Act 1994 as relevant (control code I19).

Identification Controls

I1 Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and

durability

I2 Priority identifiers for corrosive substances

I3 Priority identifiers for ecotoxic substances

I4 Priority identifiers for explosive substances

I5 Priority identifiers for flammable substances

I6 Priority identifiers for organic peroxides

I7 Priority identifiers for oxidising substances

I8 Priority identifiers for toxic substances

I9 Secondary identifiers for all hazardous substances

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I10 Secondary identifiers for corrosive substances

I11 Secondary identifiers for ecotoxic substances

I12 Secondary identifiers for explosive substances

I13 Secondary identifiers for flammable substances

I14 Secondary identifiers for organic peroxides

I15 Secondary identifiers for oxidising substances

I16 Secondary identifiers for toxic substances

I17 Use of generic names

I18 Requirements for using concentration ranges

I19 Additional information requirements, including situations where substances are in multiple packaging

I20 Durability of information for class 6.1 substances

I21 General documentation requirements

I22 Specific documentation requirements for corrosive substances

I23 Specific documentation requirements for ecotoxic substances

I24 Specific documentation requirements for explosive substances

I25 Specific documentation requirements for flammable substances

I26 Specific documentation requirements for organic peroxides

I27 Specific documentation requirements for oxidising substances

I28 Specific documentation requirements for toxic substances

I29 Signage requirements

I30 Advertising corrosive and toxic substances

The Hazardous Substances (Emergency Management) Regulations 2001 prescribe controls that

must be complied with if the levels of substance held are above the trigger quantities specified.

These controls are aimed at mitigating adverse effects in the event of a spill and prescribe specific

requirements with respect to emergency management information, emergency response plans,

secondary containment facilities and signage.

Emergency Management Controls

EM1 Level 1 information requirements for suppliers and persons in charge

EM2 Information requirements for corrosive substances

EM3 Information requirements for explosive substances

EM4 Information requirements for flammable substances

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EM5 Information requirements for oxidising substances and organic peroxides

EM6 Information requirements for toxic substances

EM7 Information requirements for ecotoxic substances

EM8 Level 2 information requirements for suppliers and persons in charge

EM9 Additional information requirements for flammable and oxidising substances and organic peroxides

EM10 Fire extinguisher requirements

EM11 Level 3 emergency management requirements: duties of person in charge, emergency response

plans

EM12 Level 3 emergency management requirements: secondary containment

EM13 Level 3 emergency management requirements: signage

The Hazardous Substances (Packaging) Regulations 2001 prescribe a number of controls aimed at

ensuring hazardous substances are adequately and appropriately packaged.

Packaging Controls

P1 General packaging requirements

P2 Specific criteria for class 4.1.2 and 5.2 substances

P3 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III

criteria

P4 Packaging requirements for explosive substances

P5 Packaging requirements for flammable liquids

P6 Packaging requirements for liquid desensitised explosives

P7 Packaging requirements for flammable solids

P8 Packaging requirements for self-reactive flammable substances

P9 Packaging requirements for substances liable to spontaneous combustion

P10 Packaging requirements for substances that emit flammable gases when in contact with water

P11 Packaging requirements for oxidising substances

P12 Packaging requirements for organic peroxides

P13 Packaging requirements for toxic substances

P14 Packaging requirements for corrosive substances

P15 Packaging requirements for ecotoxic substances

PG1 Packaging requirements equivalent to UN Packing Group I

PG2 Packaging requirements equivalent to UN Packing Group II

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PG3 Packaging requirements equivalent to UN Packing Group III

PS4 Packaging requirements as specified in Schedule 4

The Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001 prescribe a number of

controls aimed at ensuring hazardous substances are handled in a manner appropriate to their

flammable properties.

Flammability Controls

F1 General test certification requirements for hazardous substance locations

F2 Restrictions on the carriage of flammable substances on passenger service vehicles

F3 General limits on flammable substances

F4 Approved handler/security requirements for certain flammable substances

F5 Requirements regarding hazardous atmosphere zones for class 2.1.1, 2.1.2 and 3.1 substances

F6 Requirements to prevent unintended ignition of class 2.1.1, 2.1.2 and 3.1 substances

F7 Limits on ignition sources and temperature for class 3.2 and 4 substances

F8 Requirements to prevent unintended ignition of class 4.1.1 substances

F9 Requirements to prevent unintended ignition of class 4.1.2 substances

F10 Requirements to prevent unintended ignition of class 3.2 and 4.1.3 substances

F11 Segregation of incompatible substances

F12 Requirement to establish a hazardous substance locations if flammable substances are present

F13 Controls on hazardous substance locations where class 3.2 and 4 substances are present

F14 Test certification requirements for facilities where class 2.1.1, 2.1.2 or 3.1 substances are present

F15 Test certification requirements for facilities where class 3.2 or 4 substances are present

F16 Controls on transit depots where flammable substances are present

The Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 prescribe a number of

controls aimed at ensuring hazardous substances handled in a manner appropriate to their toxicity.

Toxicity Controls

T1 Limiting exposure to toxic substances through the setting of TELs

T2 Controlling exposure in places of work through the setting of WESs.

T3 Requirements for keeping records of use

T4 Requirements for equipment used to handle substances

T5 Requirements for protective clothing and equipment

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T6 Approved handler/security requirements for certain toxic substances

T7 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles

T8 Controls for vertebrate poisons

The Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 specify a number of

controls primarily aimed at limiting the extent to which the environment are exposed to hazardous

substances with ecotoxic properties.

Ecotoxicity Controls

E1 Limiting exposure to ecotoxic substances through the setting of EELs

E2 Restrictions on use of substances in application areas

E3 Controls relating to protection of terrestrial invertebrates e.g. beneficial insects

E4 Controls relating to protection of terrestrial vertebrates

E5 Requirements for keeping records of use

E6 Requirements for equipment used to handle substances

E7 Approved handler/security requirements for certain ecotoxic substances

The Hazardous Substances (Disposal) Regulations 2001 specify controls on the disposal of

substances and their containers.

Disposal Controls

D1 Disposal requirements for explosive substances

D2 Disposal requirements for flammable substances

D3 Disposal requirements for oxidising substances and organic peroxides

D4 Disposal requirements for toxic and corrosive substances

D5 Disposal requirements for ecotoxic substances

D6 Disposal requirements for packages

D7 Information requirements for manufacturers, importers and suppliers, and persons in charge

D8 Documentation requirements for manufacturers, importers and suppliers, and persons in charge

The Hazardous Substances (Tracking) Regulations 2001 specify controls for the tracking of

substances.

Tracking Controls

TR1 General tracking requirements

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The Hazardous Substances (Personnel Qualifications) Regulations 2001 specify the qualifications

required of an approved handler.

Approved handler Controls

AH1 Approved Handler requirements (including test certificate and qualification requirements)

The Hazardous Substances (Tank Wagon and Transportable Container) Regulations 2001 prescribe

a number of controls relating to tank wagons and transportable containers.

Tank Wagon and Transportable Containers Controls

The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a number

of controls relating to tank wagons and transportable containers.

Other legislation

For internal land transport within New Zealand, the Land Transport Rule: Dangerous Goods 2005 will

govern the type of transport, the qualifications of the driver and carrier, and the information

requirements for transportation including packaging. Drivers are required to carry emergency

management instructions for the substance they are carrying. For internal sea transport within New

Zealand (e.g. across the Cook Strait), packages will have to meet the labelling requirements of the

IMDG Code for the transport of dangerous goods by sea.

Under the HSE Act, employers and workers are required to be aware of all hazards.

The RMA prohibits discharge of contaminants into the environment unless it has been expressly

allowed for in a Regional Plan, resource consent or by regulation. This is relevant to all stages of the

substance‘s lifecycle, with specific relevance to the substance during its manufacturing, storage, use

and disposal.

Risk assessment and controls

The process by which the risk assessment of substances should be undertaken is specified in the

Methodology. The process requires that the risks and benefits of a substance be identified and then

assessed for their level of significance.

Potentially non-negligible risks must first be identified for evaluation following clauses 9 and 11,

(which incorporate sections 5, 6 and 8) of the Methodology. These risks must then be assessed in

accordance with sections 5 and 6 and clauses 9 and 12. The assessment must be undertaken with

regard to:

the environment,

human health and safety,

the relationship of Māori to the environment,

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society and the community,

the market economy, and

New Zealand‘s international obligations.

For the purposes of the assessment the following definitions are made in Regulation 2 of the

Methodology.

A ―cost‖ is ―the value of a particular adverse effect expressed in monetary or non-

monetary terms‖. Thus, these should be assessed in an integrated fashion together with

the risks of the adverse effects in the following assessment.

A ―benefit‖ is ―the value of a particular positive effect expressed in monetary or non-

monetary terms‖. Benefits that may arise from any of the matters set out in clauses 9

and 11 were considered in terms of clause 13.

To facilitate the assessment of risks the applicant and the staff have identified the most

common potential sources of risk to the environment and to human health and safety

through release, spillage or exposure throughout the lifecycle of the substance. These

are tabulated in Table S3.1 and are used as the basis for the risk assessment in the

―Identification and Assessment of effects‖ section of the E&R report.

Table S3.1: Potential sources of risks associated with hazardous substances

Lifecycle Activity Associated Source of Risk

Manufacture /

Import

An incident during the manufacture or importation of the substance resulting in spillage

and subsequent exposure of people or the environment to the substance.

Packing An incident during the packing of the substance resulting in spillage and subsequent

exposure of people or the environment to the substance.

Transport or storage An incident during the transport or storage of the substance resulting in spillage and

subsequent exposure of people or the environment to the substance.

Use

Application of the substance resulting in exposure of users or bystanders or the

environment; or an incident during use resulting in spillage and subsequent exposure of

users or the environment to the substance.

Disposal Disposal of the substance or packaging resulting in exposure of people or the

environment to the substance.

In undertaking the assessment the staff note that the evidence provided by the applicant and

additional evidence found by the staff, relating to the hazardous properties of the substances is

largely scientific in nature (clause 25(1)). However, as some of the evaluation of risks, costs and

benefits has been carried out on a qualitative basis, it is recognised that there is a degree of

uncertainty in the risk analysis.

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Where qualitative assessment is used at any stages of the lifecycle the level of risk has been

evaluated on the basis of the magnitude and likelihood of adverse effects occurring to people or the

environment.

In accordance with section 29, consideration is given to the likely effects of the substances being

unavailable.

As in 3.2 above outlining the aspects in which the risk assessment is undertaken in relation with, the

staff assess each application for any effects associated with the relationship of Māori to the

environment. In most cases the substance will trigger a number of hazardous properties giving rise to

the potential for cultural risk including the deterioration of the mauri of taonga flora and fauna species,

the environment and the general health and well-being of individuals and the community.

In addition, the introduction and use of hazardous substances have the potential to inhibit the ability

of iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of waterways given

the highly ecotoxic nature of the substance to aquatic species, and potential risks to the mauri ora of

human health under prolonged exposure to this substance.

Where significant effects on the relationship of Māori to the environment are identified during the

staff‘s risk assessment these will be fully discussed in the body of the E&R report. Where effects are

identified which will have a negligible impact the following process will be undertaken to ensure that

significant effects are not overlooked.

The staff will consider the information outlined in the report, to determine that there is a minimal

impact from the substance on the relationship of Māori and their culture and traditions with their

ancestral lands, water, sites, wāhi tapu, valued flora and fauna and other taonga to ensure that any

impacts are highly improbable.

If this is determined the overall level of risk will therefore be considered to be negligible assuming that

the substance will be handled, stored, transported, used, and disposed of, in accordance with the

explicitly stated default and additional controls proposed in the report, and any other controls required

by other legislation.

However, the staff will propose that should inappropriate use, or accident, result in the contamination

of waterways or the environment generally, that users will be required to notify the appropriate

authorities including the relevant iwi authorities in that region. This action should include advising

them of the contamination and the measures taken to contain and remediate.

Human Health Risk Assessment

The staff have undertaken an assessment of risks to operator health using the United Kingdom

Pesticide Safety Directorate‘s interpretation of the German BBA Model to estimate operator exposure

during the use of Relent. This model estimates the exposure of workers to a pesticide during mixing,

loading and during spray application, in mg/kg person/day. The derived values consider both dermal

and inhalation exposure routes.

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Typically, the staff use the geometric mean model. The BBA model provides for a range of different

spray applications (tractor-mounted/trailed sprayers and hand-held sprayers) and formulation types

(liquid, wettable powder and wettable granule). Additionally, the BBA model also allows flexibility to

vary protective clothing (hands, head and body).

Calculation of NOEL

The toxicological endpoint used for assessment of occupational (worker) and re-entry worker risks is

the AOEL (Acceptable Operator Exposure Level). The AOEL is the maximum amount of active

substance to which the operator/re-entry worker may be exposed with a low probability of adverse

health effects amongst the healthy worker sub-population, allowing for some margin of safety. AOELs

describe the internal (absorbed) dose available for systemic distribution from any route of absorption

and are expressed as internal (systemic) levels (mg/kg bw/day). They are derived by dividing the

most appropriate NOAEL from relevant studies by one or more uncertainty (safety) factors selected

on the basis of the extent and quality of the available data, the species for which data are available

and the nature of the effects observed. An absorption factor may be applied to take into account the

absorbed dose in the study where this is known (this is a percentage expressed as a factor).

Bystander Risk Assessment

The staff consider that the main potential source of exposure to the general public for substances of

this type (other than via food residues which will be considered as part of the registration of this

substance under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997) is via

spray drift. In terms of bystander exposure, toddlers are regarded as the most sensitive sub-

population and are regarded as having the greatest exposures. For these reasons, the risk of

bystander exposure is assessed in this sub-population. The oral chronic reference dose (CRfD), or

an equivalent threshold such as an ADE, ADI or a general population DN(M)EL is selected because

these are an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure

to the human population (including sensitive subgroups) that is likely to be without an appreciable risk

of deleterious effects during a lifetime. Thus, the bystander exposure risk assessment estimates the

life-time risk associated with repeated daily exposure of the most sensitive human sub-population

over their lifespan.

Output of Human Bystander Mixing, Loading and Application Exposure Modelling

Exposure is estimated using the equations from the UK Health & Safety Chemical Regulation

Directorate which account for dermal exposure, hand-to-mouth exposure and object-to-mouth

exposure

In addition, incidental ingestion of soil is taken into account using a modified exposure equation from

the United States Environmental Protection Agency (USEPA, 2007, Standard Operating Procedures

(SOPs) for Residential Exposure Assessments, Contract No. 68-W6-0030, Work Assignment No.

3385.102). Spray drift is estimated using models specific to the type of application equipment. For

pesticides applied by ground boom or air blast sprayer, the AgDrift model is used. Spray drift

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deposition from aerial application is estimated using the AGDISP model along with appropriate New

Zealand input parameters.

Re-entry Worker Exposures

The staff assessed the re-entry worker exposures using the generic exposure model for

―Maintenance and harvesting activities: Dermal exposure‖ provided by the UK Health & Safety

Executive chemical Regulation Directorate.

Environmental Risk Assessment

For Class 9 substances, irrespective of the intrinsic hazard classification, the ecological risk can be

assessed for a substance by calculating a risk quotient based on an estimated exposure

concentration. Such calculations incorporate toxicity values, exposure scenarios (including spray drift,

application rates and frequencies), and the half lives of the component(s) in soil and water. The

calculations provide an Estimated Environmental Concentration (EEC) which, when divided by the

LC50 or EC50, gives a risk quotient (RQ).

Acute RQ = EECshort term Chronic RQ = EEClong term LC50 or EC50 NOEC

If the RQ exceeds a predefined level of concern, this suggests that it may be appropriate to refine the

assessment or to apply the approved handler (AH) control and/or other controls to ensure that

appropriate matters are taken into account to minimize off-site movement of the substance.

Conversely, if a worst-case scenario is used, and the level of concern is not exceeded, then in terms

of the environment, there is a presumption of low risk which is able to be adequately managed by

such things as label statements (warnings, disposal). The AH control can then be removed on a

selective basis.

The staff used the Generic Estimated Environmental Concentration Model v2 (GENEEC2) surface

water exposure mod to estimate the EEC of the relevant active components in surface water which

may potentially arise as a result of spray drift and surface runoff from the applicant‘s proposed New

Zealand use pattern.

Controls

Tolerable Exposure Limits (Control Code T1)

Tolerable Exposure Limits (TELs) are designed to limit the extent to which the general public is

exposed to hazardous (toxic) substances. A TEL represents the maximum concentration of a

substance legally allowable in a particular medium (air, water, soil or a surface that a hazardous

substance may be deposited onto), and can be set as either a guideline value or an action level that

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should not be exceeded. TELs are derived from PDE (Potential Daily Exposure) values which are, in

turn, derived from ADE (Acceptable Daily Exposure) values or reference doses (RfD). An RfD is

similar to ADE but is used to protect against a specific toxic effect of concern. Human exposure may

also occur through food or drinking water. Exposure through food is managed via the establishment

of Maximum Residue Limits (MRLs) as set by the Minister of Food Safety on the advice of the New

Zealand Food Safety Authority (NZFSA). Exposure through drinking water is managed via the

establishment of Maximum Acceptable Values (MAVs) as set by the Ministry of Health. MRLs and

MAVs are also established from ADE values.

Acceptable Daily Exposures

An ADE is an amount of a hazardous substance (mg/kg bodyweight/day), that, given a lifetime of

daily exposure, would be unlikely to result in adverse human health effects. An RfD (reference dose)

is a similar measure that can be used to protect against a specific toxic effect of concern. §11(1) of

the Hazardous Substances (Classes 6, 8 and 9) Controls Regulations 2001 determines when an

ADE/RfD is required to be set.

Regulation 11(1) of the Hazardous Substances (Classes 6, 8 and 9) Controls Regulations 2001

determines when an ADE/RfD is required to be set:

(1) This regulation applies to a class 6 substance if- (a) it is likely to be present in-

(i) 1 or more environmental media; or (ii) food; or (iii) other matter that might be ingested; AND

(b) it is a substance to which a person is likely to be exposed on 1 or more occasions during the lifetime of the person; AND

(c) exposure to the substance is likely to result in an appreciable toxic effect.

If all three requirements of regulation 11(1) are met, then an ADE/RfD should be set for the relevant

component(s), and PDE and TEL values subsequently established for each relevant exposure route.

Potential Daily Exposures

If an ADE or RfD value is set for a substance, or component of a substance, a PDE value for each

relevant exposure route must also be set. A PDE is an amount of substance (mg/kg

bodyweight/day), calculated in accordance with §23 of the Hazardous Substances (Classes 6, 8 and

9) Controls Regulations 2001, that estimates the relative likelihood of particular exposures. A PDE

for any single exposure route is a fraction of the ADE or RfD, and the sum of all PDE values from all

possible exposures must be less than or equal to the ADE or RfD. The main routes of exposure

considered are ingestion (food, water, air, soil), inhalation (air) and skin contact (surface deposition,

water, soil).

Workplace Exposure Standards (Control Code T2)

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Workplace Exposure Standards (WES) are designed to protect persons in the workplace from the

adverse effects of toxic substances. A WES is an airborne concentration of a substance (expressed

as mg substance/m3 of air, or ppm in air), which must not be exceeded in a workplace and only

applies to places of work (§29(2), Hazardous substances (Classes 6, 8 and 9 Controls) Regulations

2001). If all three of the requirements of §29(2) this regulation are met then a WES is required to be

set.

Regulation 29 states:

(1) This regulation and regulation 30 apply to a class 6 substance if,- (a) under the temperature and pressure the substance is to be used in, it can

become airborne and disperse in air in the form of inspirable or respirable dust, mists, fumes, gases or vapours; AND

(b) human exposure to the substance is primarily through the inhalation or dermal

exposure routes; AND (c) the toxicological and industrial hygiene data available for the substance is

sufficient to enable a standard to be set.

When setting WES, the Authority must either adopt a value already proposed by the Department of

Labour or already set under HSNO or derive a value by taking into account the matters described in

§30(2) of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations. Typically the staff

adopt WES values listed in the Workplace Exposure Standards and Biological Exposure Indices

(Effective from September 2010) document

(http://www.osh.dol.govt.nz/order/catalogue/pdf/wes2010.pdf

Environmental Exposure Limits (Control Code E1)

Section 33 of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 specify that

an environmental exposure limit (EEL) may be set for a Class 9 substance for one or more

environmental media if organisms that live in that environment may be exposed to the substance. An

EEL is the (maximum) concentration of a substance in an environmental medium that will present a

negligible risk of adverse environmental effects to organisms (excluding humans) in non-target areas.

As specified by §32, a default EEL of 0.1 µg/L water is set for any class 9.1 substance, and 1 µg/kg

soil (dry weight) for any class 9.2 substance. For the purposes of setting EELs, an environmental

medium is defined as water, soil or sediment where these are in the natural environment, or a surface

onto which a hazardous substance may be deposited.

An EEL can be established by one of three means:

applying the default EELs specified in §32;

adopting an established EEL as provided by §35(a);

calculating an EEL from an assessment of available ecotoxicological data as provided by

§35(b).

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The Hazardous Substances and New Organisms (Approvals and Enforcement) Act 2005 added a

new section (s77B) to the HSNO Act, which, amongst other things provided the Authority with the

ability to set EELs as guideline values, rather than the previous pass/fail values. However, until the

staff have developed formal policy on the implementation of s77B, it proposes not to set EELs for any

components of this substance at this time. It is also proposed that the default EEL water and soil

values be deleted until the policy has been established.

Maximum Application Rates (Control Code E2)

These regulations relate to the requirement to set an application rate for a class 9 substance that is to

be sprayed or applied to an area of land (or air or water) and for which an EEL has been set.

Identification Controls - Identification of Toxic and/or Corrosive Components on

Labels/Documentation (SDS)

The Hazardous Substances (Identification) Regulations 2001 specify that certain toxic and/or

corrosive components are required to be specified on the product label and on SDS documentation.

The toxic components required to be specified on the product label are defined by §19(f), 25(e), 25(f),

and 39(5).

Identification of toxic components on labels

Regulations 25(e) and 25(f) require that certain toxic components are required to be specified on

the product label.

Regulation 25(e) states:

...a toxic substance must be identified by...

'information identifying, by its common or chemical name, every ingredient, that would, independently of any other ingredient, give the substance a hazard classification of 6.1A, 6.1B, 6.1C, 6.5, 6.6, 6.7, 6.8 or 6.9, and the concentration of that ingredient in the substance."

Regulation 25(f) states:

...a toxic substance must be identified by...

"information identifying every ingredient (other than an ingredient referred to in paragraph (e)) that would, independently of any other ingredient, gives the substance a hazard classification of 6.1D, and the concentration of the ingredient that would contribute the most to that classification."

Identification of corrosive components on labels

Regulation 19(f) requires that certain corrosive components are required to be specified on the

product label.

Regulation 19(f) states:

…a corrosive substance must be identified by…

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―If the substance contains any ingredient in such a concentration that the ingredient would, independently of any other ingredient, cause the substance to be classified as class 8.2 or class 8.3, in respect of each such ingredient,- (i) its common or chemical name; and (ii) a statement of its concentration in the substance.‖

Identification of toxic and/or corrosive components on SDS

Regulation 39(5) of the Hazardous Substances (Identification) Regulations 2001, states that

certain corrosive and toxic components are required to be specified on documentation.

Regulations 39(5) states:

"The requirements of regulation 19(f) or (as the case requires) regulation 25(e) apply to all documentation; but any ingredient required by that provision to be identified (other than an ingredient to which regulation 26 applies) must also be identified by any Chemical Abstract Services number allocated to it."

Qualitative descriptors for risk/benefit assessment

This section describes how the staff and the Authority address the qualitative assessment of risks,

costs and benefits. Risks and benefits are assessed by estimating the magnitude and nature of the

possible effects and the likelihood of their occurrence. For each effect, the combination of these two

components determines the level of the risk associated with that effect, which is a two dimensional

concept. Because of lack of data, risks are often presented as singular results. In reality, they are

better represented by ‗families‘ of data which link probability with different levels of outcome

(magnitude).

The magnitude of effect is described in terms of the element that might be affected. The qualitative

descriptors for magnitude of effect are surrogate measures that should be used to gauge the end

effect or the ‗what if‘ element. Tables S4.1 and S4.2 contain generic descriptors for magnitude of

adverse and beneficial effect. These descriptors are examples only, and their generic nature means

that it may be difficult to use them in some particular circumstances. They are included here to

illustrate how qualitative tables may be used to represent levels of adverse and beneficial effect.

Table S4.1 Magnitude of adverse effect (risks and costs)

Descriptor Examples of descriptions - Adverse

Minimal

Mild reversible short term adverse health effects to individuals in highly localised area

Highly localised and contained environmental impact, affecting a few (less than ten) individuals

members of communities of flora or fauna, no discernible ecosystem impact

Local/regional short-term adverse economic effects on small organisations (businesses,

individuals), temporary job losses

No social disruption

Minor

Mild reversible short term adverse health effects to identified and isolated groups

Localised and contained reversible environmental impact, some local plant or animal communities

temporarily damaged, no discernible ecosystem impact or species damage

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Regional adverse economic effects on small organisations (businesses, individuals) lasting less

than six months, temporary job losses

Potential social disruption (community placed on alert)

Moderate

Minor irreversible health effects to individuals and/or reversible medium term adverse health effects

to larger (but surrounding) community (requiring hospitalisation)

Measurable long term damage to local plant and animal communities, but no obvious spread

beyond defined boundaries, medium term individual ecosystem damage, no species damage

Medium term (one to five years) regional adverse economic effects with some national implications,

medium term job losses

Some social disruption (e.g. people delayed)

Major

Significant irreversible adverse health effects affecting individuals and requiring hospitalisation

and/or reversible adverse health effects reaching beyond the immediate community

Long term/irreversible damage to localised ecosystem but no species loss

Measurable adverse effect on GDP, some long term (more than five years) job losses

Social disruption to surrounding community, including some evacuations

Massive

Significant irreversible adverse health effects reaching beyond the immediate community and/or

deaths

Extensive irreversible ecosystem damage, including species loss

Significant on-going adverse effect on GDP, long term job losses on a national basis

Major social disruption with entire surrounding area evacuated and impacts on wider community

Table S4.2 Magnitude of beneficial effect (benefits)

Descriptor Examples of descriptions - Beneficial

Minimal

Mild short term positive health effects to individuals in highly localised area

Highly localised and contained environmental impact, affecting a few (less than ten) individuals

members of communities of flora or fauna, no discernible ecosystem impact

Local/regional short-term beneficial economic effects on small organisations (businesses,

individuals), temporary job creation

No social effect

Minor

Mild short term beneficial health effects to identified and isolated groups

Localised and contained beneficial environmental impact, no discernible ecosystem impact

Regional beneficial economic effects on small organisations (businesses, individuals) lasting less

than six months, temporary job creation

Minor localised community benefit

Moderate

Minor health benefits to individuals and/or medium term health impacts on larger (but surrounding)

community and health status groups

Measurable benefit to localised plant and animal communities expected to pertain to medium term

Medium term (one to five years) regional beneficial economic effects with some national

implications, medium term job creation

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Local community and some individuals beyond immediate community receive social benefit.

Major

Significant beneficial health effects to localised community and specific groups in wider community

Long term benefit to localised ecosystem(s)

Measurable beneficial effect on GDP, some long term (more than five years) job creation

Substantial social benefit to surrounding community, and individuals in wider community.

Massive

Significant long term beneficial health effects to the wider community

Long term, wide spread benefits to species and/or ecosystems

Significant on-going effect beneficial on GDP, long term job creation on a national basis

Major social benefit affecting wider community

The likelihood applies to the composite likelihood of the end effect, and not either to the initiating

event, or any one of the intermediary events. It includes:

the concept of an initiating event (triggering the hazard), and

the exposure pathway that links the source (hazard) and the area of impact (public

health, environment, economy, or community).

Thus, the likelihood is not the likelihood of an organism escaping, or the frequency of accidents for

trucks containing hazardous substances, but the likelihood of the specified adverse effect3 resulting

from that initiating event. It will be a combination of the likelihood of the initiating event and several

intermediary likelihoods4. The best way to determine the likelihood is to specify and analyse the

complete pathway from source to impact.

Likelihood may be expressed as a frequency or a probability. While frequency is often expressed as

a number of events within a given time period, it may also be expressed as the number of events per

head of (exposed) population. As a probability, the likelihood is dimensionless and refers to the

number of events of interest divided by the total number of events (range 0-1).

Table S4.3 Likelihood

Descriptor Description

Highly improbable Almost certainly not occurring but cannot be totally ruled out

Very unlikely Considered only to occur in very unusual circumstances

Unlikely (occasional) Could occur, but is not expected to occur under normal operating conditions

Likely A good chance that it may occur under normal operating conditions

Highly likely Almost certain, or expected to occur if all conditions met

3 The specified effect refers to scenarios established in order to establish the representative risk, and may be as

specific as x people suffering adverse health effects, or y% of a bird population being adversely affected. The risks included in the analysis may be those related to a single scenario, or may be defined as a combination of several scenarios.

4 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.

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Using the magnitude and likelihood tables a matrix representing a level of risk/benefit can be

constructed.

In the example shown in Table S4.4, four levels of risk/benefit are allocated: A (negligible), B (low), C

(medium), and D (high). These terms have been used to avoid confusion with the descriptions used

for likelihood and magnitude, and to emphasise that the matrix is a tool to help decide which

risks/benefits require further analysis to determine their significance in the decision making process.

For negative effects, the levels are used to show how risks can be reduced by the application of

additional controls. Where the table is used for positive effects it may also be possible for controls to

be applied to ensure that a particular level of benefit is achieved, but this is not a common approach.

The purpose of developing the tables for both risk and benefit is so that the risks and benefits can be

compared.

Table S4.4 Level of risk

Magnitude of effect

Likelihood Minimal Minor Moderate Major Massive

Highly improbable A A A B B

Very unlikely A A B B C

Unlikely A B B C C

Likely B B C C D

Highly likely B C C D D

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Decision Path

1

Review the content of the

application and all relevant

information

2

Is this information sufficient

to proceed?

5

Identify the composition of the substance,

classify the hazardous properties of the

substance, and determine default controls

6

Identify all risks, costs and benefits that are

potentially non-negligible

7

Assess each risk assuming controls in place.

Add, substitute or delete controls in

accordance with clause 35 and sections77,

77A, 77B

8

Undertake combined consideration of all risks

and costs, cognisant of proposed controls

9

Are all risks with controls in place

negligible?

10

Review controls for cost-effectiveness in

accordance with clause 35 and sections 77,

77A, 77B

11

Is it evident that benefits outweigh

costs?

16

Confirm and set controls

Approve

(section 29(1)(a))

3

Seek additional

information

4

Sufficient?

Decline (section 29(1)(c))

12

Establish position on risk averseness

and appropriate level of caution

13

Review controls for cost-effectiveness

in accordance with clause 35 and

sections 77, 77A, 77B

14

Assess benefits

15

Taking into account controls,

do positive effects outweigh adverse

effects?

Decline

(section 29(1)(b))

Clause 27

Clause 26

No

No

No

No

Yes

Yes

Yes

Yes

Yes

No

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