ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

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ENVIRONMENTAL RISK MANAGEMENT

AUTHORITY DECISION

Application code:

Application Type

Applicant:

Purpose of the Application

Date application received:

Consideration Date

Considered by

2 July 2008

HSR08017

To import or manufacture any hazardous substance under Section 28A(2)(b) of the Hazardous Substances and New Organisms Act 1996.

Southwell Products Ltd

To import or manufacture Chlorine Dioxide as a broad spectrum fungicide for use on field crops. (low hazard)

15 May 2008

2 July 2008

Rob Forlong (Chief Executive, ERMA New Zealand)

1

Summary of decision

1.1

The application to import or manufacture the proposed substance for release is approved with the controls as set out in Appendix 1. This approval has been given in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (“the Act”), the relevant HSNO Regulations, and the HSNO (Methodology) Order 1998 (“the Methodology”), based on the proposed substance being formulated so that the substance has one or more hazardous properties and each hazardous property has the least degree of hazard for that property.

1.2

The proposed substance has been given the following unique identifier for the

ERMA New Zealand Hazardous Substances Register:

Chlorine Dioxide in Aqueous Solution

2

Legislative criteria for the application

2.1

Unless otherwise stated, references to section numbers in this decision refer to sections of the Act. The application was lodged pursuant to section 28. The decision was determined in accordance with section 28A(2)(b), taking into account the requirements of that section and matters specified under Part II of the Act.

2.2

Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology. Consideration of the application followed the relevant provisions of the Methodology.

3

Application process

3.1

The purpose of this application is to gain approval to import or manufacture

Chlorine Dioxide in Aqueous Solution as a fungicide.

3.2

The application was formally received on 15 May 2008.

3.2.1

The application timeframe was extended by three working days due to an information request made under section 52.

3.2.2

The consideration of the application was postponed by 20 working days under section 58(1).

3.3

The Agricultural Compounds & Veterinary Medicines Group (ACVMG) of the

New Zealand Food Safety Authority (NZFSA), the Department of Conservation and the Department of Labour Workplace Group were advised of the application (clause 2(2)(e)).

3.3.1

No responses were received.

3.4

Evaluation of the application was undertaken by the ERMA New Zealand project team which comprised the following staff members:

Margaret Keane

Cora Drijver

Peter Dawson

Advisor (Hazardous Substances)

Advisor (Hazardous Substances)

Principal Scientist (Hazardous Substances)

3.5

The application was considered by the Chief Executive of ERMA New Zealand as provided for by a delegation from the Authority under section 19(2)(d).

4

Consideration

Sequence of the consideration

4.1

Southwell Products Ltd seeks approval, under section 28, to import or manufacture Chlorine Dioxide in Aqueous Solution for release in New Zealand.

4.2

An application can be assessed by rapid assessment procedures, under section

28A(2)(b), if it can be shown that Chlorine Dioxide in Aqueous Solution has one or more hazardous properties and each hazardous property has the least degree of hazard for that property.

4.3

The approach adopted when considering this application was:

 to review the information provided;

 to identify the composition and hazardous properties of the proposed substance, Chlorine Dioxide in Aqueous Solution;

Environmental Risk Management Authority Decision: Application HSR08017 Page 2 of 23

 to determine whether Chlorine Dioxide in Aqueous Solution has one or more hazardous properties and each hazardous property has the least degree of hazard for that property.

4.4

And then:

 to consider whether there are any other effects that mean Chlorine

Dioxide in Aqueous Solution should not be approved under section 28A; and

 to consider whether the controls that apply under the Act will prevent or manage the adverse effects of Chlorine Dioxide in Aqueous Solution.

Information review

4.5

The project team has reviewed the information supplied by Southwell Products

Ltd, and considers that the information constitutes an adequate and appropriate basis for assessing the application (clause 8). They also consider that there are no significant uncertainties (ie sufficient to influence decision making) in the scientific and technical information relating to the risks of Chlorine Dioxide in

Aqueous Solution (clauses 29 and 30).

Identification of Chlorine Dioxide in Aqueous Solution

4.6

Chlorine Dioxide in Aqueous Solution is a soluble concentrate containing chlorine dioxide as the active ingredient.

Use of Chlorine Dioxide in Aqueous Solution

4.7

Chlorine Dioxide in Aqueous Solution is intended for use as a broad spectrum fungicide on apples, pears, grapes, stone fruit, kiwi fruit, tangelos, berryfruit, asparagus, greenhouse tomatoes, fine turf and cotular.

Hazardous properties of Chlorine Dioxide in Aqueous Solution

4.8

The project team has determined the hazard profile of Chlorine Dioxide in

Aqueous Solution based on the information provided by the applicant and other available information. The hazard classifications for Chlorine Dioxide in

Aqueous Solution are set out in Table 4.1.

Table 4.1: Hazard classification

Hazardous Property

Aquatic Ecotoxicity

Chlorine Dioxide in

Aqueous Solution

9.1D

Meeting the criteria for rapid assessment under section 28A(2)(b)

4.9

Based on the information presented in Table 4.1, the project team considers that the criteria for rapid assessment under section 28A(2)(b) have been met in that the substance has been formulated with the hazardous property having the least degree of hazard for that property.

Environmental Risk Management Authority Decision: Application HSR08017 Page 3 of 23

4.10

The project team considers that there are no other matters which would prevent this application for Chlorine Dioxide in Aqueous Solution from being rapidly assessed.

5

Controls and Risk Assessment

Default controls

5.1

Based on the hazard classifications determined for the proposed substance, a set of associated default controls has been identified by the project team as being applicable to Chlorine Dioxide in Aqueous Solution. These default controls, expressed as control codes

1

, are listed in Table 5.1

.

5.2

Additional controls under section 77A are available to manage the risks associated with Chlorine Dioxide in Aqueous Solution, which are not addressed by the default controls. These are considered in paragraph 5.11.2 below.

Table 5.1: List of default controls for Chlorine Dioxide in Aqueous Solution

Ecotoxicity Controls

E1 Limiting exposure to ecotoxic substances through the setting of EELs

E2

E6

Restrictions on use of substances in application areas

Requirements for equipment used to handle substances

Identification Controls

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

I9

I11

I19

I21

I29

Secondary identifiers for all hazardous substances

Secondary identifiers for ecotoxic substances

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

General documentation requirements

Signage requirements

Packaging Controls

P1 General packaging requirements

P3 Criteria that allow substances to be packaged to a standard not meeting

Packing Group I, II or III criteria

PS4 Packaging requirements as specified in Schedule 4

Disposal Controls

D5

D6

D7

D8

Disposal requirements for ecotoxic

Disposal requirements for packages

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

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

Emergency Management Controls

EM1 Level 1 information requirements for suppliers and persons in charge

EM7 Information requirements for ecotoxic substances

EM8 Level 2 information requirements for suppliers and persons in charge

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

1 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 ERMA New Zealand User Guide to the Controls Regulations.

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emergency response plans

EM12 Level 3 emergency management requirements: secondary containment

EM13 Level 3 emergency management requirements: signage

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.

Assessment of the adverse effects

5.3

5.4

The project team has evaluated the potential of Chlorine Dioxide in Aqueous

Solution to cause adverse effects to the environment (non-target organisms) during all stages of the substance’s lifecycle. Quantitative and qualitative risk assessments were carried out to assess these risks (refer to Appendix 2 for qualitative descriptors of risk).

Assessment of risks to the environment

Chlorine Dioxide in Aqueous Solution is classified as 9.1D (aquatic ecotoxicant). A quantitative risk assessment was carried out by the project team to consider the risks to the environment during use of the proposed substance.

Acute risk was identified for fish, but the project team considers that this risk can be mitigated through restricted use (see Appendix 3 for detail) by means of adding the approved handlers control E7.

5.5

A qualitative risk assessment was carried out by the project team to consider the risks to the environment over the remainder of the product life-cycle. The risks are considered to be negligible based on the following:

5.5.1

The project team considers that it is highly improbable that the environment will be exposed to these substances in such a manner as to cause any adverse effects, given adherence to HSNO controls (e.g. packaging, identification, emergency management and disposal), transport regulations and the Resource Management Act (RMA).

5.6

5.5.2

If exposure were to occur, the project team considers that the magnitude of any adverse effect will be minor as the effect would be localised with no discernible ecosystem impact.

Assessment of risks to human health

Chlorine Dioxide in Aqueous Solution has not been classified with any toxic properties; however, the chlorine dioxide in its gaseous, undiluted form is extremely toxic to humans. Human exposure would be via inhalation upon application of the proposed substance during use, but the risk of adverse effect is assessed by the project team as being negligible due to the very low concentration at which chlorine dioxide is present in the formulation.

Relationship of Māori to the Environment

5.7

The project team notes that the hazard classifications triggered by Chlorine

Dioxide in Aqueous Solution give rise to the potential for cultural risk including the deterioration of the mauri of taonga flora and fauna species, the environment

Environmental Risk Management Authority Decision: Application HSR08017 Page 5 of 23

5.8

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.

On considering the information available, the project team considers a minimal impact from Chlorine Dioxide in Aqueous Solution 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 highly improbable . In addition there is no evidence to suggest that the controlled use of Chlorine Dioxide in

Aqueous Solution will breach the principles of the Treaty of Waitangi.

5.9

The overall level of risk is therefore considered to be negligible given that the substance is 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.

5.10

However, the project team notes 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.

Modification of controls and setting of exposure limits

5.11

The project team has reviewed the effectiveness of the default controls for

Chlorine Dioxide in Aqueous Solution in managing the identified risks and costs associated with the substance. Consequently a number of variations of the default controls and additional controls are considered appropriate. The variations, additions and the setting of exposure limits and applications rates are discussed below.

Controls relating to the setting of exposure limits and application rates

5.11.1

The controls relating to the setting of exposure limits are varied as follows:

Controls Comment

E1 No EEL values are set for any component of Chlorine Dioxide in

Aqueous Solution at this time and the default EEL values are deleted.

E2 As no EEL value has been set, no application rate is required to be set at this time. However, a maximum application rate and application frequency has been set as an additional control under

77A (see paragraph 5.11.2 below) for Chlorine Dioxide in

Aqueous Solution on the basis of quantitative risk assessment modelling conducted by the project team.

Additional controls

5.11.2

The following controls are added under section 77A as being more effective in terms of their effect on the management, use and risks of

Chlorine Dioxide in Aqueous Solution:

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Controls Comment

Though the proposed substance has not had any toxic hazard classifications conferred on it by the project team, as discussed in the risk assessment section, chlorine dioxide is extremely toxic to humans in its concentrated form. In order to mitigate any risks to users associated with exposure to the proposed substance, the project team has set the Department of Labour WES for chlorine dioxide as follows: chlorine dioxide: TWA

1

: 0.1 ppm (0.28 mg/m

3

)

The project team considers that the application rate proposed by the applicant and used in the quantitative risk assessment modelling should be set as a maximum application rate (see Appendix 3 for detail regarding the modelling), as being more effective in managing the risk of unintended exposure to the aquatic environment than the default controls: max. application rate: 0.02 kg ai/ha

E7/AH1 The proposed use in New Zealand is to be widely dispersive as a pesticide. Based on the results of a quantitative assessment the project team considers that applying the Approved Handler control will be more effective in managing the risk of unintended exposure to the aquatic environment than the default controls.

EM12 The following subclauses are added after subclause (3) of regulation 36 2 (control EM12):

(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.

EM12 The following subclauses are added after subclause (3) of regulation 37 1 (control EM12):

(2) 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

1 TWA: Time Weighted Average

2 Hazardous Substances (Emergency Management) Regulations 2001

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Controls Comment capacity of the greater of—

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

(ii) 5,000 litres.

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

EM12 The following subclauses are added after subclause (3) of regulation 38 1 (control EM12):

(2) 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

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

Sch 8 Addition of controls relating to stationary container systems as set out in Schedule 8 1

Use

Control

Addition of a use restriction control as follows:

Chlorine Dioxide in Aqueous Solution shall not be applied onto or into water 2 .

5.12

The additions and modifications to the default controls for Chlorine Dioxide in

Aqueous Solution, as above, have been incorporated into the list of controls for

Chlorine Dioxide in Aqueous Solution detailed in Appendix 1.

6

Environmental user charges

6.1

The project team considers that use of controls on Chlorine Dioxide in Aqueous

Solution is an effective means of managing risks associated with this substance.

At this time, no consideration has been given to whether or not environmental charges should be applied to this substance as an alternative or additional means of achieving effective risk management. Accordingly, no report has been made to the Minister for the Environment.

1 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

2 where ‘water’ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern.

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7

Decision

7.1

Pursuant to section 28A, I have considered this application to import or manufacture a hazardous substance for release made under section 28.

7.2

Having considered the composition, hazardous properties, and proposed use of

Chlorine Dioxide in Aqueous Solution, I am satisfied that the proposed substance meets the criteria for rapid assessment under section 28A(2)(b) in that it has one or more hazardous properties and each hazardous property has the least degree of hazard for that property.

7.3

I am satisfied with the hazard classifications identified by the project team in paragraph 4.8 and accordingly confer them on the proposed substance.

7.4

As the risks posed by Chlorine Dioxide in Aqueous Solution are negligible, I consider that applying the HSNO default controls to Chlorine Dioxide in

Aqueous Solution, with the additions and amendments proposed under paragraphs 5.11 to 5.11.2 (inclusive), will ensure adequate management of any adverse effects of Chlorine Dioxide in Aqueous Solution.

7.5

In this consideration, I have also applied the following criteria in the

Methodology:

 clause 9 – equivalent of sections 5, 6 and 8;

 clause 12 – risk assessment;

 clause 21 – the decision accords with the requirements of the Act and regulations;

 clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques;

 clause 25 – the evaluation of risks; and

 clause 35 – the costs and benefits of varying the default controls.

7.6

The application for importation and manufacture of the hazardous substance,

Chlorine Dioxide in Aqueous Solution for release is thus approved with controls as detailed in Appendix 1.

Rob Forlong

Chief Executive, ERMA New Zealand

Chlorine Dioxide in Aqueous Solution

ERMA New Zealand Approval Code:

Date: 2 July 2008

HSR007938

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Appendix 1: Controls applying to Chlorine Dioxide in

Aqueous Solution

The controls imposed on Chlorine Dioxide in Aqueous Solution are as follows. The regulations cited should be referred to for definitions and exemptions. The ERMA New

Zealand publication User Guide to Control Regulations provides useful guidance on the controls.

Table A1.1: Controls for Chlorine Dioxide in Aqueous Solution – codes, regulations and variations

Control

Code 1 Regulation 2 Topic Variations

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

Controls

E1

E2

32 – 45

46 – 48

Limiting exposure to ecotoxic substances through the setting of EELs

Restrictions on use of substances in application areas

No EEL values are set for

Chlorine Dioxide in Aqueous

Solution at this time and the default EEL values are deleted.

A maximum application rate has been set for Chlorine Dioxide in

Aqueous Solution, as an additional control under 77A

(see below).

E6

E7

7

9

Requirements for equipment used to handle substances

Approved handler/security requirements for certain ecotoxic substances

Hazardous Substances (Identification) Regulations 2001

I1 6, 7, 32-35, General identification requirements

36 (1)-(7)

Regulation 6 – Identification duties of suppliers

Regulation 7 – Identification duties of persons in charge

Regulations 32 and 33 – Accessibility of information

Regulations 34, 35, 36(1)-(7) –

Comprehensibility, Clarity and

Durability of information

I9

I11

18

20

Secondary identifiers for all hazardous substances

Secondary identifiers for ecotoxic substances

This control has been added under section 77A (see below).

1

Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.

2 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only.

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Control

Code 1

I19

I21

I29

Regulation 2 Topic

29-31 Alternative information in certain cases

Regulation 29 – Substances in fixed bulk containers or bulk transport containers

Regulation 30 – Substances in multiple packaging

Regulation 31 – Alternative information when substances are imported

37-39, 47-

50

Documentation required in places of work

51, 52

Regulation 37 – Documentation duties of suppliers

Regulation 38 – Documentation duties of persons in charge of places of work

Regulation 39 – General content requirements for documentation

Regulation 47 – Information not included in approval

Regulation 48 – Location and presentation requirements for documentation

Regulation 49 – Documentation requirements for vehicles

Regulation 50 – Documentation to be supplied on request

Specific documentation requirements for ecotoxic substances

Hazardous Substances (Packaging) Regulations 2001

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

Regulation 5 – Ability to retain contents

Regulation 6 – Packaging markings

Regulation 7(1) – Requirements when packing hazardous substance

Regulation 8 – Compatibility

Variations

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Control

Code

P3

PS4

1 Regulation 2 Topic

Regulation 9A and 9B – Large

Packaging

9 Packaging requirements for substances packed in limited quantities

Schedule 4 This schedule describes the minimum packaging requirements that must be complied with for this substance.

Variations

Hazardous Substances (Disposal) Regulations 2001

D5 9 Disposal requirements for ecotoxic

D6

D7

10

11, 12

Disposal requirements for packages

Disposal information requirements

D8 13, 14 Disposal documentation requirements

Hazardous Substances (Emergency Management) Regulations 2001

EM1 6, 7, 9-11

EM7 8(f)

Level 1 emergency management information: General requirements

Information requirements for ecotoxic substances

EM8

EM11

EM12

12-16, 18-

20

25-34

35-41

Level 2 emergency management documentation requirements

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

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

The following subclauses are added after subclause (3) of regulation 36:

(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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Control

Code 1 Regulation 2 Topic Variations

The following subclauses are added at the end of regulation

37:

(2) 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.

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

The following subclauses are added at the end of regulation

38:

(2) 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

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Control

Code 1 Regulation 2 Topic Variations 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

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

EM13 42 Level 3 emergency management requirements: signage

Hazardous Substances (Personnel Qualifications) Regulations 2001

AH1 4 – 6 Approved Handler requirements See control E7.

(including test certificate and qualification requirements)

Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004

Regulations 4 to 43 The Hazardous Substances (Tank where applicable Wagons and Transportable Containers)

Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant.

Additional controls set under s77A

WES set for chlorine dioxide: TWA: 0.1 ppm (0.28 mg/m 3 ) maximum application rate: 0.02 kg ai/ha

Addition of controls E7 and AH1 (see paragraph 5.11.2).

Addition of subclauses after subclause (3) of regulation 36 and at the end of regulations 37 and 38 of the Hazardous Substances (Emergency Management Controls) Regulations 2001 (control EM12).

The controls relating to stationary container systems, as set out in Schedule 8 of the 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 that schedule.

Chlorine Dioxide in Aqueous Solution shall not be applied onto or into water.

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Appendix 2: Qualitative descriptors

A2.1 Assessing risks, costs and benefits qualitatively

This section describes how the Agency 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 a 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).

A2.2 Describing the magnitude of effect

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 A2.1 and A2.3 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.

The sample qualitative descriptors for effects on the market economy listed in the ERMA

New Zealand technical guide to decision making 1 include representative numbers. These

‘economic’ descriptors were developed prior to the publication of the technical guide on identification and assessment of effects on the market economy, 2 which refines the approach that ERMA New Zealand applies to identifying and assessing economic effects. These numbers do not align well with the qualitative descriptors in the other categories (effects on the environment, effects on human health, and effects on society and communities), as they relate more to an event than an effect. In particular the numbers are unclear about how they take account of time (are they annual, or over the life of the activity) and they do not have a local, regional or national context.

ERMA New Zealand has adopted a revised set of qualitative descriptors for the magnitude of effect on the market economy, as shown below.

Table A2.1: Magnitude of adverse effect (risks and costs).

Descriptor

Minimal

Examples of descriptions: ADVERSE

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

1 ERMA New Zealand. 2004. Decision Making: A Technical Guide to Identifying, Assessing and Evaluating Risks, Costs and Benefits ,

ER-TG-05-01. Wellington: Environmental Risk Management Authority.

2 ERMA New Zealand. 2005. Assessment of Economic Risks, Costs and Benefits: Consideration of Impacts on the Market Economy , ER-

TG-06-01. Wellington: Environmental Risk Management Authority.

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Descriptor

Minor

Moderate

Major

Massive

Examples of descriptions: ADVERSE

(businesses, individuals), temporary job losses

No social disruption

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

Regional adverse economic effects on small organisations (businesses, individuals) lasting less than six months, temporary job losses

Potential social disruption (community placed on alert)

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)

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

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 A2.2: Magnitude of beneficial effect (benefits).

Descriptor

Minimal

Minor

Moderate

Examples of descriptions: BENEFICIAL

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

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

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

Environmental Risk Management Authority Decision: Application HSR08017 Page 16 of 23

Descriptor

Major

Massive

Examples of descriptions: BENEFICIAL medium term.

Medium term (one to five years) regional beneficial economic effects with some national implications, medium term job creation

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

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.

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

A2.3 Determining the likelihood of the end effect

Likelihood in this context 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 the likelihood of the specified adverse effect 1 resulting from that initiating event. It will be a combination of the likelihood of the initiating event and several intermediary likelihoods 2 . 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). (See Table A2.3.)

Table A2.3: Likelihood.

Descriptor Description

1

2

3

4

Highly improbable

Improbable

(remote)

Very unlikely

Unlikely

Almost certainly not occurring but cannot be totally ruled out

Only occurring in very exceptional circumstances.

Considered only to occur in very unusual circumstances

Could occur, but is not expected to occur under normal operating

1 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.

2 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.

Environmental Risk Management Authority Decision: Application HSR08017 Page 17 of 23

5

6

7

Descriptor

(occasional)

Likely

Very likely

Extremely likely

Description conditions.

A good chance that it may occur under normal operating conditions.

Expected to occur if all conditions met

Almost certain

A2.4 Using magnitude and likelihood to construct the level of risk and benefit

Using the magnitude and likelihood tables a matrix representing a level of effect can be constructed (Table A2.4).

Table A2.4: Level of effect.

Magnitude of effect

Likelihood Minimal Minor Moderate Major Massive

Highly improbable

Improbable

Very unlikely

Unlikely

Likely

Very likely

A

A

B

C

D

E

A

B

C

D

E

E

B

C

D

E

E

F

C

D

E

E

F

F

D

Extremely likely

E F F F

The Agency considers that, for this substance, the level of risk/benefit can be assigned as follows in Table A2.5.

F

E

E

F

F

F

Table A2.5: Assignment of level of risk/benefit .

A & B

C

D

E

F

Negligible

Low

Medium

High

Extreme

Environmental Risk Management Authority Decision: Application HSR08017 Page 18 of 23

Appendix 3: Quantitative risk assessment

Environmental Exposure Assessment

The applicant provides the following information that is relevant to assess the environmental risks.

Chlorine dioxide has a high water solubility, especially in cold water, and it does not hydrolyze when it enters water. Chlorine dioxide remains a dissolved gas in solution.

It is a very unstable substance and it decomposes when it comes in contact with sunlight. The best way to store the product is as a liquid at 4 o C. Chlorine dioxide gas is used to sterilise medical and laboratory equipment, surfaces, rooms and tools. As a disinfectant and pesticide it is mainly used in liquid form. According to the MSDS the product is not anticipated to cause adverse effects to animal or plant life if released to the environment in small quantities.

It is not expected to bio-accumulate.

US EPA assessed chlorine dioxide used as a disinfectant, a sanitizer and a sterilant.

The application rate varies from 1 till 1406 ppm depending on the use. Chlorine dioxide has a short half-life and in the presence of sunlight will break down into chloride and chlorate ions

(between pH 4 and 7). At pH lower than 4, its breakdown products are chlorite and chlorate.

Chlorite is the dominant breakdown product. Chlorate and chlorite ions tend only undergo biodegradation under anaerobic conditions. The end products are the chloride and oxygen. No adsorption/desorption constants have been measured for either chlorite or chlorate. These ions are likely to be mobile and may travel from surface to groundwater easily. The estimated

K ow

of chlorine dioxide is – 3.22. It is not expected that chlorine dioxide would bioaccumulate in aquatic organisms.

US EPA assessed the risk for the use in cooling towers at the application rate of 25 ppm. The conclusion is that there is a risk to freshwater and marine/estuarine fish, invertebrates and aquatic plants. To mitigate the risk the maximum application rate is set on 5 ppm. All other exposure and risk estimates are below US EPA’s level of concern.

Due to the proposed uses in New Zealand the environmental exposure will be greater than the exposure assessed by US EPA. Therefore the Agency runs the Generic Estimated

Environmental Concentration Model v2 (GENEEC2) surface water exposure model (USEPA

2001) to assess the risk for the aquatic organisms. The calculations provide an Estimated

Environmental Concentration (EEC) which, when divided by the LC

50

or EC

50

, gives a risk quotient (RQ).

Acute RQ = EEC short term

LC

50

or EC

50

Chronic RQ = EEC long term

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 control

(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.

Environmental Risk Management Authority Decision: Application HSR08017 Page 19 of 23

Levels of concern (LOC) developed by the USEPA (Urban and Cook 1986) and adopted by

ERMA New Zealand, to determine whether a substance poses an environmental risk are provided in Table 2.

Table 1: Levels of concern as adopted by ERMA New Zealand

Endpoint LOC Presumption

Aquatic (fish, invertebrates)

Acute RQ≥

0.5 High acute risk

Acute RQ 0.1-0.5 Risk can be mitigated through restricted use

Acute RQ< 0.1

Chronic RQ≥

1

Low risk

High chronic risk

Plants (aquatic and terrestrial)

Acute RQ≥ 1 High acute risk

Mammals and birds

Acute dietary 0.5

RQ≥

Acute oral dose 0.5

[granular products] RQ≥

Chronic RQ≥

1

High acute risk

High acute risk

High chronic risk

The parameters used in the GENEEC2 modeling are listed in Table 3 and represent the recommended use on grapes.

Table 2: Input parameters for GENEEC2 analysis

Chlorine dioxide Reference

Application rate 0.02 kg ai/ha

Application frequency

Application interval

3-5

10

Data provided by applicant for SOS application

Agency’s assumptions based on the intended use, the applicant stated that it can be used as often as required.

K d

/K oc

0.000211 As both K d and K oc are not known, the Agency used a default of 0.35 x

K ow

.

Estimated Log K ow

= -3.22,

K ow

= 0.000603 [source EPA RED chlorine dioxide, 2006]

Aerobic soil DT

50

Pesticide wetted in?

0

No

Methods of application Airblast spray

Not known

Environmental Risk Management Authority Decision: Application HSR08017 Page 20 of 23

‘No spray’ zone

Water solubility

Aerobic aquatic DT

50

0

3010 mg/L

0

EPA RED chlorine dioxide, 2006

Not known

Aqueous photolysis

DT

50

0 Not known

Hydrolysis 0 Not known

The Agency run the model twice for 5 and 3 applications. Due to a lack on data the Agency used the default for some values.

Output from the GENEEC2 model.

5 applications

RUN No. 2 FOR chlorine dioxide ON grapes * INPUT VALUES *

--------------------------------------------------------------------------------------------

RATE (lb/ac) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

ONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)

--------------------------------------------------------------------------------------------

.018( .089) 5 10 .0 3010.0 ORCHAR( 9.7) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------------------------------------

METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

------------------------------------------------------------------------------------------------

.00 2 N/A .00- .00 .00 .00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

---------------------------------------------------------------------------------------------

PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------------------------------

5.43 5.43 5.43 5.43 5.43

3 applications

RUN No. 1 FOR chlorine dioxide ON grapes * INPUT VALUES *

-------------------------------------------------------------------------------------------

RATE (lb/ac) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

ONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)

-------------------------------------------------------------------------------------------

.018( .053) 3 10 .0 3010.0 ORCHAR( 9.7) .0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

----------------------------------------------------------------------------------------------

METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

------------------------------------------------------------------------------------------------

.00 2 N/A .00- .00 .00 .00

Environmental Risk Management Authority Decision: Application HSR08017 Page 21 of 23

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

------------------------------------------------------------------------------------------------

PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

---------------------------- --------------------------------------------------------------------

3.26 3.26 3.26 3.26 3.26

The Estimated Environmental Concentration (EEC) for chlorine dioxide as estimated by

GENEEC2 is:

5 applications: Peak and chronic EEC 0.00543 mg/L.

3 applications: Peak and chronic EEC 0.00326 mg/L.

Assessment of acute risk

Information used in the risk assessment:

Species: Fathead minnow

Type of exposure: Flow through

Duration: 96 hr

Endpoint: LC50

Value: 0.02 mg/l

Reference: Wilde EW et al; Water Res 17 (10): 1327-32 (1983)

The Estimated Environmental Concentration (EEC) for chlorine dioxide as estimated by

GENEEC2 are shown in Table 4, along with the aquatic data for chlorine dioxide for the most sensitive species tested (further details on these toxicity data are included in Table

A2.7).

Table 3: Acute risk quotients derived from the GENEEC2 model and toxicity data.

Peak EEC from

GENEEC2 (mg/L)

LC

50

or EC

50

(mg/L)

RQ (Acute)

EEC/ LC

50

or EC

50

Fish

Crustacea

0.00543 (5 appl.) 0.02

-

0.272

-

Algae - -

Fish

Crustacea

0.00326 (3 appl.) 0.02

-

0.163

-

Algae - -

When compared against the relevant acute risk quotients (Table 4), the acute RQs derived from the GENEEC2 modeling for chlorine dioxide indicate the following:

For fish: the acute risk can be mitigated through restricted use

For crustacean and algae: it is not possible to assess the acute risk

Based on the acute RQs for fish, the Agency considers it is appropriate to introduce the approved handler controls for Southwell AC when it is used in a wide dispersive manner, or

Environmental Risk Management Authority Decision: Application HSR08017 Page 22 of 23

by a commercial contractor. Further, the Agency considers that the application rate proposed by the applicant and used in the modeling should be set as a maximum application rate.

Chlorine dioxide degrades very quickly therefore the Agency considers there is no need to restrict the application frequency.

Environmental Risk Management Authority Decision: Application HSR08017 Page 23 of 23

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