ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

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Amended under s67A on 18 December 2006

ENVIRONMENTAL RISK MANAGEMENT AUTHORITY

DECISION

Application code

Application type

Applicant

Applicant contact:

Purpose

Date received

Consideration date

Considered by

1

10 May 2006

HSR06042

To import or manufacture any hazardous substance under Section

28A(2)(a) of the Hazardous Substances and New Organisms

(HSNO) Act 1996

AgriSource Limited

PO Box 789

Pukekohe

AUCKLAND

Fraser Wilson

Fenafos 400: to import for commercial release a toxic and ecotoxic pesticide for the control of nematodes in various horticultural and ornamental crops (rapid similar).

19 April 2006

10 May 2006

Rob Forlong (Chief Executive, ERMA New Zealand)

Summary of Decision

1.1

1.2

1.3

The application to import or manufacture Fenafos 400 is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms

Act 1996 (the HSNO Act), the relevant HSNO Regulations, and the HSNO

(Methodology) Order 1998 (the Methodology), based on its similar composition and similar hazardous properties to a substance that has been approved by the Authority.

The substance has been given the following unique identifier for the ERMA New Zealand

Hazardous Substances Register:

Fenafos 400

ERMA New Zealand has adopted the European Union use classification system as the basis for recording the nature and uses of substances approved. The following use categories are recorded for this substance:

Main Category:

Industrial category:

Function/Use category:

4

1

38

Wide Dispersive Use

Agricultural Industry

Pesticides

2

2.1

Legislative Criteria for Application

2.2

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

HSNO Act.

Consideration of the application followed the relevant provisions of the Methodology.

Unless otherwise stated, references to clauses in this decision refer to clauses of the

Methodology.

Application Process

3

3.1

3.2

3.3

3.4

3.5

4

The purpose of the application is to import Fenafos 400 for use as a pesticide.

The application was formally received on 19 April 2006.

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

Health and the Department of Labour Workplace Group were advised of the application

(clause 2(2)(e)).

A response was received from the ACVMG indicating that:

“As this application will be considered under the ACVM Act, any issues which may arise under the Acts administered by MAF/NZFSA will be considered as part of that application .”

Project Team:

Margaret Keane

Laura Docker

Report review and sign-out by:

Dr Peter Dawson

Applications Advisor (Hazardous Substances)

Science Advisor (Hazardous Substances)

Principal Scientist (Hazardous Substances)

Consideration

4.1

4.2

Sequence of the Consideration

AgriSource Ltd seeks approval under section 28A(2)(a) of the HSNO Act to import or manufacture Fenafos 400.

Under section 28A(2)(a), an application can be assessed under rapid assessment procedures if it can be shown that a substance having a similar composition and similar hazardous properties has been approved by the Authority. Decision-making authority for such rapid assessments has been delegated to the Chief Executive of ERMA New Zealand

(section 19(2)(d)).

Environmental Risk Management Authority Decision: Application HSR06042 Page 2 of 27

4.3

The approach adopted when considering this application was:

To identify the composition and hazardous properties of the proposed substance,

Fenafos 400, and of the “reference” similar substance provided by AgriSource Ltd or other appropriate reference substance;

To determine whether Fenafos 400 has a similar composition and similar hazardous properties to the reference substance.

4.4

And then:

To determine whether Fenafos 400 has a similar life-cycle to the reference substance;

To consider whether the risks posed by Fenafos 400 are the same as, less than or greater than those posed by the reference substance;

To consider whether there are any other effects which mean that Fenafos 400 should not be rapidly assessed; and

To consider whether the controls that apply under the HSNO Act to the reference substance are applicable to Fenafos 400.

4.5

Information Review

I have reviewed the information supplied by AgriSource Ltd and consider that the information constitutes an adequate and appropriate basis for considering the application

(clause 8). There are no significant uncertainties (i.e. sufficient to influence decision making) in the scientific and technical information relating to the risks of the substance

(clauses 29 and 30).

4.6

4.7

4.8

Composition of Fenafos 400 Relative to that of the Reference Substance

AgriSource Ltd identified a reference substance against which Fenafos 400 should be compared as an insecticide which was transferred to the HSNO Act on 1 July 2004 under the generic substance description of “emulsifiable concentrate containing 400g/L fenamiphos” and given the ERMA Approval Code HSR000198.

After considering AgriSource Ltd’s reference substance and other potential reference substances, I consider that there is a valid approved reference substance against which

Fenafos 400 can be compared.

Both substances are organophosphate insecticides containing 400 g/litre of the active ingredient fenamiphos for use on a variety of horticultural and ornamental crops, for the control of nematodes. There are some differences, however, in other components in the formulations. The application rates are very similar for both substances.

4.9

Both Fenafos 400 and the reference substance are emulsifiable concentrates.

4.10

It is noted that incomplete compositional information has been provided on Components

A and B present in Fenafos 400. However, these components are commonly used as surfactants in pesticide formulations, and the classifications assigned (based partially on compositional information and partially on MSDS information) have been used in previous applications.

4.11

The concentration of major hazardous components are less in Fenafos 400 than in the reference substance.

Environmental Risk Management Authority Decision: Application HSR06042 Page 3 of 27

4.12

After taking the variations in composition into account, I have concluded that the compositions of Fenafos 400 and the reference substance are of the same nature and kind.

Therefore, I am satisfied that Fenafos 400 has a similar composition to the reference substance.

Hazardous Properties of Fenafos 400 Relative to the Reference Substance

4.13

AgriSource Ltd has provided information related to the hazardous properties of Fenafos

400.

4.14

Under section 28A(2)(a), Fenafos 400 must have similar hazardous properties to the reference substance. The hazardous properties of Fenafos 400 and the reference substance are listed below:

Flammability

Skin irritancy

Eye irritancy

Hazard Endpoint

Acute toxicity

Reproductive / developmental toxicity

Target organ systemic toxicity

Aquatic ecotoxicity

Soil ecotoxicity

Terrestrial vertebrate ecotoxicity

Terrestrial invertebrate toxicity

Fenafos 400

3.1D

6.1B

6.3B

6.4A

-

6.9A

9.1A

9.2B

9.3A

9.4A

Reference

Substance

3.1C

6.1B

6.3A

6.4A

6.8B

6.9A

9.1A

9.2B

9.3A

9.4A

4.15

The hazard profile of Fenafos 400 is less than that of the reference substance and therefore fulfils the hazardous properties criteria for rapid similar assessment as described in the

ERMA NZ Policy Series, Rapid Assessment (ER-PO-HS-01).

Evaluation against the Criteria for Similar Composition and Similar

Hazardous Properties

4.16

I consider that, based on the application submitted by AgriSource Ltd, and on information available on the reference substance, the analysis in the preceding paragraphs shows that the criteria for similar composition and similar hazardous properties under section

28A(2)(a) have been met.

Part II Matters (Non Scientific Considerations)

4.17

No information has arisen during the consideration of this application that has caused me to believe that the substance, with controls in place, could result in significant effects on:

The sustainability of native and valued introduced flora and fauna;

The intrinsic value of ecosystems;

Public health;

The relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga;

The economic and related benefits to be derived from the use of Fenafos 400;

 New Zealand’s international obligations.

Environmental Risk Management Authority Decision: Application HSR06042 Page 4 of 27

5

5.1

5.2

5.3

5.4

5.5

5.6

5.7

5.8

Life-cycle, Risks and Controls

The product is manufactured in Germany and shipped to New Zealand in sealed containers as a ready-to-use formulation. The product will arrive at the New Zealand port in its own shipping container. Fenafos 400 will arrive labeled with an ACVMG approved label and packed in 20 L fluorescent HDPE containers and shrunk wrapped on to pallets.

The quantities imported at any one time are limited, are on indent order and are in volumes that are not large for local storage for any length of time. If local storage is necessary for a short period of time whilst awaiting delivery to the end user, this would only be in Pukekohe at one specific facility designed and appointed for the storage of hazardous substances and agricultural compounds.

The unopened sealed containers are transported from the wharf by properly designated carriers of hazardous substances and delivered directly to three large vegetable growers only -it will not be available for sale in a 'retail farm supply store'. Transportation to the user is by specific designated carriers of hazardous substances, such as Chemcouriers.

The proposed uses are those approved by the ACVM Group NZFSA, for the reference substance, for the control of nematodes in various horticultural and ornamental crops. The use pattern, rates and timing of use is identical or very similar to the reference substance.

This is summarised as follows.

Crop carrots kumaras lucerne potatoes kiwifruit roses

Pest root knot nematode root knot nematode root knot nematode potato cyst nematode root knot nematode root knot nematode

20 L/ha

20 L/ha

20-25 L/ha

20 L/ha

Rate

40 ml/10 L root soak

20-50 ml/10 L root soak

The substance is diluted with water and applied by means of calibrated broadcast ground spray vehicular equipment.

The pattern of use is such that the substance will be stored in the original container and will not be decanted but used until the container is empty. The need to dispose of any small amount of original undiluted substance is unlikely and not envisaged. When empty, the container will be rinsed with water and the rinsate incorporated into the spray mixture in the spray tank for application. The empty, rinsed 20 L fluorescent HDPE container will be either recycled or crushed and buried in a landfill.

Taking into account the similar use of Fenafos 400 and the reference substance, I consider that the risks associated with the use of Fenafos 400 will be no greater than those of the reference substance.

I note that there are no other matters (section 6) that would prevent this application for

Fenafos 400 from being approved by rapid assessment.

I therefore consider that, given the similarities in composition, hazard properties and the risks associated with the life-cycle, the controls and as applied to the reference substance are equally applicable to Fenafos 400 with the following variations:

Environmental Risk Management Authority Decision: Application HSR06042 Page 5 of 27

5.9

Additional Controls under Section 77A

The following controls are applicable to Fenafos 400 under section 77A:

5.10

“The controls relating to stationary container systems (as provided in Schedule 8 of the

Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer

Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128,

1 October 2004 and by Issue No. 208, 16 December 2005), shall apply to this substance, notwithstanding clause 1(1) of the schedule.”

5.11

I note that, as a means of managing the risks from Fenafos 400, additional controls relating to stationary container systems are necessary. These provisions are currently provided in Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled

Toxic Substances) Transfer Notice 2004 (New Zealand Gazette of 26 March 2004, No. 35, as amended by No. 128, 1 October 2004 and No. 208, 16 December 2005).

5.12

These additional controls are applied to the reference substance and I consider them to be equally applicable to Fenafos 400.

5.13

The controls relating to secondary containment, as set out in Schedule 9 of the Hazardous

Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New

Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October

2004 and by Issue No. 208, 16 December 2005), shall apply to this substance, notwithstanding clause 1(1) of that schedule.

5.14

The controls relating to secondary containment, as set out in Schedule 9 of the Hazardous

Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New

Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October

2004 and by Issue No. 208, 16 December 2005), shall apply to Fenafos 400, notwithstanding clause 1(1) of that schedule.

5.15

The controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, set out in Schedule 10 of the New Zealand Gazette Notice of

Thursday, 25 March 2004, Issue Number 35, as amended by the New Zealand Gazette

Notice of Friday, 1 October 2004, Issue Number 128, and by Issue No. 208 Friday, 16

December 2005, shall apply, as applicable, notwithstanding clause 1 of the schedule.

5.16

I note that, as a means of managing the risks from Fenafos 400, the HSNO Act provides for regulations to be made, prescribing controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances (section 75(1)(b)). These provisions are currently in the form of controls on dangerous goods in Schedule 10 of the New

Zealand Gazette Notice of Thursday, 25 March 2004, Issue Number 35, as amended by the New Zealand Gazette Notice of Friday, 1 October 2004, Issue Number 128, and by

Issue No. 208 Friday, 16 December 2005.

5.17

I consider that controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, are necessary to manage Fenafos 400, and note that no other such controls have been specified under the HSNO Act.

5.18

The following regulation was inserted after regulation 9 of the Hazardous Substances

(Classes 6, 8 and 9) Controls) Regulations 2001 for the reference substance and apply also to Fenafos 400:

9A Exception to approved handler requirement for transportation of packaged pesticides

Environmental Risk Management Authority Decision: Application HSR06042 Page 6 of 27

(1) Regulation 9 is deemed to be complied with if—

(a) when this substance is being transported on land—

(i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with the approved safety system for the time being approved under section 6D of the Transport

Services Licensing Act 1989; and

(ii) other than by rail the person who drives, loads, and unloads the vehicle that is transporting the substance has a current dangerous goods endorsement on his or her driver licence; and

(iii) in all cases, Land Transport Rule: Dangerous Goods 1999 (Rule

45001) is complied with; or

(b) when this substance is being transported by sea, one of the following is complied with:

(i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods

(MR024A):

(ii) International Maritime Dangerous Goods Code; or

(c) when this substance is being transported by air, Part 92 of the Civil

Aviation Rules is complied with.

(2) Subclause (1)(a)—

(a) does not apply to a tank wagon or a transportable container to which the

Hazardous Substances (Tank Wagons and Transportable Containers)

Regulations 2004 applies; but

(b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN Model Regulations.

(3) Subclause (1)(c)—

(a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but

(b) does not apply to the handling of this substance in any place that is not within an aerodrome;

(4) In this regulation, UN Model Regulations means the 13th revised edition of the Recommendation on the transport of Dangerous Goods Model

Regulations, published in 2003 by the United Nations.

5.19

The following subclauses shall be added after subclause (3) of regulation 36 of the

Hazardous Substances (Emergency Management) Regulations 2001:

(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.

Control code EM12 relates to level 3 emergency management requirements. I consider that as a means of managing the risks from Fenafos 400 , the above sub-clauses are necessary. I note that these sub-clauses have been applied to the reference substance by

Environmental Risk Management Authority Decision: Application HSR06042 Page 7 of 27

Gazette Notice (Issue No. 72). I consider that these controls are relevant to this substance, and note that no other such controls have been specified under the HSNO Act. In accordance with section 77A(4)(a) of the HSNO Act, I am satisfied that imposing these additional controls is more effective than any other specified controls in terms of their effect on the management, use and risks of Fenafos 400.

5.20

The Hazardous Substances (Pesticides) (Amendment) Transfer Notice 2006 states that, unless specifically allowed for, no pesticide may be applied onto or into water. As Fenafos

400 is not approved for such use, the following control is applied to Fenafos 400:

Fenafos 400 must not be applied directly onto or into water.

Variation of Controls under Section 77

5.21

The following default controls have not been listed as the conditions required for the controls to be triggered have not been met based on the lifecycle of the substance:

Control T8 , as it specifies requirements for class 6.1 substances that are (lawfully) laid or applied outdoors for terrestrial vertebrate pest control.

Control E4 , as it relates to class 9.3 substances that are intentionally released into the environment in granular form or coated on seeds for the purposes of terrestrial vertebrate pest control.

5.22

Control code E1 relates to the requirements for setting Environmental Exposure Limits

(EELs). ERMA New Zealand is considering a range of issues to do with EELs, including their setting, measurement and enforcement following the passage of amendments to the

HSNO Act in December 2005. Accordingly, no EELs are being set for Fenafos 400 under regulation 35 of the Hazardous Substances (Classes 6, 8, and 9 Controls)

Regulations 2001 and the default EELs set under regulation 32, which would otherwise have applied, are deleted under section 77(4)(b).

5.23

Control code E2 relates to the setting of application rates. No application rate has been set for the reference substance, therefore none has been set for Fenafos 400 at this time.

5.24

Control code T1 relates to limiting exposure to toxic substances through the setting of

TELs. ERMA New Zealand is considering a range of issues to do with TELs, including their setting, measurement and enforcement following the passage of amendments to the

HSNO Act in December 2005. I note that TELs have not previously been set for the reference substance and accordingly no TELs are set at this time for Fenafos 400.

5.25

Control code T2 relates to controlling exposure in places of work through the setting of

WESs. For the reference substance, WES values specified in the document described as

“Workplace Exposure Standards”, published by the Occupational Safety and Health

Service (OSH), Department of Labour, January 2002, were adopted as applicable. The

Department of Labour has set a Time Weighted Average (TWA) WES for Fenamiphos at

0.1 mg/m

3

(TWA) and Component A(1) at 50 ppm, 152 mg/m

3

(TWA). These values are applicable to Fenafos 400:

Fenamiphos, WES (TWA) = 0.1 mg/m 3

Component A(1), WES (TWA) = 152 mg/m 3 , 50 ppm

5.26

Control codes F2 and T7 are combined under section 77(5) as they both relate to restrictions to public transportation of Fenafos 400.

Environmental Risk Management Authority Decision: Application HSR06042 Page 8 of 27

5.27

Control codes T3 and E5 are combined under section 77(5) as they both relate to requirement for keeping records of use of Fenafos 400.

5.28

Control codes T4 and E6 are combined under section 77(5) as they both relate to requirements for equipment used to handle Fenafos 400.

5.29

Control codes T6 and E7 are combined under section 77(5) as they both relate to approved handler requirements.

5.30

Control codes P3 , P13 and P15 are combined under section 77(5) as they all relate to packaging requirements for the substance.

5.31

Control codes D2, D4 and D5 are combined under section 77(5) as they all relate to disposal requirements for Fenafos 400.

5.32

There have also been changes in legislation subsequent to the approval of the reference substance. These regulatory changes now also apply to the reference substance (section

77(2)(a)).

5.33

The list of controls for Fenafos 400 is detailed in Appendix 1.

6

6.1

6.2

Environmental User Charges

Section 96 of the HSNO Act 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.

I consider that the use of controls is the most effective means of managing the risks throughout the life cycle of Fenafos 400. The imposition of an environmental user charge instead of, or in combination with controls, is therefore not required at this time.

7

7.1

7.2

Decision

Having considered the composition and hazardous properties for Fenafos 400, I am satisfied that this substance meets the criteria for rapid assessment under section 28A(2)(a) of the HSNO Act in that it has a similar composition and similar hazardous properties to an approved substance.

In considering Fenafos 400 to be similar to an existing substance approved under section

29 of the HSNO Act, in accordance with clause 36(2)(b) of the Methodology, I have considered section 28A(2)(a) of the HSNO Act and also applied the following criteria in the Methodology:

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

 clause 12 – evaluation of assessment of risks;

 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.

Environmental Risk Management Authority Decision: Application HSR06042 Page 9 of 27

7.3

7.4

Having regard for the controls that applied to the reference substance, I am satisfied that the controls imposed will be adequate to manage the adverse effects of Fenafos 400.

The application is accordingly approved pursuant to section 28A(2)(a) of the HSNO Act with controls as listed in Appendix 1.

Rob Forlong

Chief Executive, ERMA New Zealand

ERMA New Zealand Approval code:

Fenafos 400

Date 10 May 2006

HSR002480

Environmental Risk Management Authority Decision: Application HSR06042 Page 10 of 27

Amendment December 2006

(a) Addition of a s77A control stating:

Fenafos 400 must not be applied directly onto or into water

___________________________________

Rob Forlong

Chief Executive

Date

18 December 2006

___________________

Environmental Risk Management Authority Decision: Application HSR06042 Page 11 of 27

Appendix 1: Controls Applying to Fenafos 400

The controls imposed on Fenafos 400 are as follows. The regulations cited should be referred to for definitions and exemptions. The ERMA New Zealand publication “User Guide to HSNO Control

Regulations” provides useful guidance on the controls.

Control

Code 1

Regulation 2 Explanation 3

Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property

Controls

F2, T7 8, 10

F6 60-70

General public transportation restrictions and requirements for Fenafos 400

In order to limit the potential for public exposure to Fenafos 400, the maximum quantity per package of it permitted to be carried on passenger service vehicles is

0.1 L .

Requirements to reduce the likelihood of unintended ignition of class 2.1.1, class 2.1.2 and class 3.1 substances.

These regulations prescribe controls to reduce the likelihood of unintended ignition of Fenafos 400. Controls are prescribed with the aim of covering all foreseeable circumstances in which unintended ignition could take place, and include:

 placing limits on the proportion of flammable vapour to air to ensure that the proportion of flammable vapour to air will always be sufficiently outside the flammable range, so that ignition cannot take place; and

 ensuring that there is insufficient energy available for ignition. This energy could be in the form of either temperature or ignition energy (e.g. a spark).

Accordingly, the controls provide two approaches to ensure that there is insufficient energy for ignition:

(1) keeping the temperature of the substance, or the temperature of any surface in contact with the substance, below 80% of the auto-ignition temperature of the substance, and

(2) keeping sources of ignition below the minimum ignition energy, either by removal of the ignition source from any location where flammable substances are handled, or by protecting the “general” mass of flammable material from the ignition source, e.g. by enclosing any ignition sources in an enclosure that will not allow the propagation of the flame to the outside; or using flameproof motors especially designed to prevent ignition energy escaping.

F11 76

It should be noted that any person handling any quantity of Fenafos 400 under any of regulations 63(4), 65, 67 and 69 must be an approved handler for that substance, i.e. the trigger quantities that typically activate approved handler requirements do not apply [Regulation 60(2)].

Segregation of incompatible substances

In order to reduce the likelihood of unintended ignition of Fenafos 400, there is a requirement to ensure that the substance does not come into contact with any incompatible substance or material, e.g. by keeping class 4.2 substances away from air and by keeping class 4.3 substances away from water. There is also a requirement that packages of incompatible substances are held separately. A list of substances and materials considered incompatible with

All class 1 substances;

Fenafos 400 follows:

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.

3

These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.

Environmental Risk Management Authority Decision: Application HSR06042 Page 12 of 27

All class 2 substances;

Class 3.2 substances;

All class 4 substances; and

All class 5 substances

This regulation does not apply to substances that are located on a vehicle, ship or aircraft if they are segregated in accordance with the Land Transport Rules, the

Maritime Rules or the Civil Aviation Rules as relevant.

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

T1 11-27 Limiting exposure to toxic substances

This control relates to limiting public exposure to Fenafos 400 through the setting of tolerable exposure limits (TELs). A TEL represents the maximum allowable concentration of a substance legally allowable in a particular environmental medium. TEL values are established by the Authority and are enforceable controls under the HSNO Act. TELs are derived from potential daily exposure (PDE) values, which in turn are derived from acceptable daily exposure

(ADE)/reference dose (RfD) values.

An ADE / RfD value must be set for a toxic substance if:

 it is likely to be present in an environmental medium (air, water, soil or a surface that the substance may be deposited onto) or food or other matter that might be ingested; and

 it is a substance to which people are likely to be exposed to during their lifetime; and

 exposure is likely to result in an appreciable toxic effect.

If an ADE/RfD value is set for a substance, a PDE for each exposure route must also be set for the substance. The PDE is a measure of the relative likelihood of a person actually being exposed to the substance through a particular exposure route given daily living patterns.

T2 29, 30

No TELs have been set at this time.

Controlling exposure in places of work

A workplace exposure standard (WES) is designed to protect persons in the workplace from the adverse effects of Fenafos 400. A WES is an airborne concentration of a substance (expressed as mg substance/m 3 of air or ppm in air), which must not be exceeded in a workplace and applies to every place of work.

The following WESs have been set for Fenafos 400:

Fenamiphos, WES (TWA) = 0.1 mg/m 3

Component A(1), WES (TWA) = 152 mg/m 3 , 50 ppm

T3, E5 5(1), 5(2), 6 Requirements for keeping records of use

A person using Fenafos 400 for the purposes of causing biocidal action must keep written records of each use if the application is in an area where members of the public may be present, or where Fenafos 400 is likely to enter air or water and leave the place.

The information to be provided in the record is described in Regulation 6(1). The record must be kept for a minimum of three years following the use and must be made available to an enforcement officer on request.

T4, E6 7 Requirements for equipment used to handle hazardous substances

Any equipment used to handle Fenafos 400 (e.g. spray equipment) must retain and/or dispense it in the manner intended, i.e. without leakage, and must be accompanied by sufficient information so that this can be achieved.

Environmental Risk Management Authority Decision: Application HSR06042 Page 13 of 27

T5 8

T6, E7 9

Requirements for protective clothing and equipment

Protective clothing/equipment must be employed when Fenafos 400 is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person does not come into contact with Fenafos 400 and is not directly exposed to a concentration of the substances that is greater than the WES for that substance.

The person in charge must ensure that people using the protective clothing/equipment have access to sufficient information specifying how the clothing/equipment may be used, and the requirements for maintaining the clothing/equipment.

Approved handler requirements

Where Fenafos 400 is held or used in any quantity , it must generally be under the personal control of an approved handler, or locked up. However, Fenafos 400 may be handled by a person who is not an approved handler if:

 an approved handler is present at the facility where the substance is being handled; and

 the approved handler has provided guidance to the person in respect of handling; and

 the approved handler is available at all times to provide assistance if necessary.

The following additional regulation is applicable to Fenafos 400:

9A Exception to approved handler requirement for transportation of packaged pesticides

(1) Regulation 9 is deemed to be complied with if—

(a) when this substance is being transported on land—

(i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with the approved safety system for the time being approved under section 6D of the

Transport Services Licensing Act 1989; and

(ii) other than by rail the person who drives, loads, and unloads the vehicle that is transporting the substance has a current dangerous goods endorsement on his or her driver licence; and

(iii) in all cases, Land Transport Rule: Dangerous

Goods 1999 (Rule 45001) is complied with; or

(b) when this substance is being transported by sea, one of the following is complied with:

(i) Maritime Rules: Part 24A – Carriage of Cargoes –

Dangerous Goods (MR024A):

(ii) International Maritime Dangerous Goods Code; or

(c) when this substance is being transported by air, Part 92 of the Civil Aviation Rules is complied with.

(2) Subclause (1)(a)—

(a) does not apply to a tank wagon or a transportable container to which the Hazardous Substances (Tank

Wagons and Transportable Containers) Regulations

2004 applies; but

(b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN

Model Regulations.

Environmental Risk Management Authority Decision: Application HSR06042 Page 14 of 27

(3) Subclause (1)(c)—

(a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but

(b) does not apply to the handling of this substance in any place that is not within an aerodrome;

(4) In this regulation, UN Model Regulations means the 13th revised edition of the Recommendation on the transport of

Dangerous Goods Model Regulations, published in 2003 by

the United Nations

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

E1 32-45 Limiting exposure to ecotoxic substances

This control relates to the setting of environmental exposure limits (EELs). An

EEL establishes the maximum concentration of an ecotoxic substance legally allowable in a particular (non target) environmental medium (e.g. soil or sediment or water), including deposition of a substance onto surfaces (e.g. as in spray drift deposition).

An EEL can be established by one of three means:

 applying the default EELs specified;

 adopting an established EEL;

 calculating an EEL from an assessment of available ecotoxicological data.

E2

E3

46-48

49

No EELs are set at this time. The default EELs have been deleted.

Restrictions on use within application area

These Regulations relate to controls on application areas. An application (target) area is an area that the person using the substance either has control over or is otherwise authorised to apply the substance to. For ecotoxic substances that are intentionally released into the environment (e.g. pesticides), any EEL controls will not apply within the application (target) area providing the substance is applied at a rate that does not exceed the allowed application rate. In addition, any approved handler controls (T6, Regulation 9) do not apply once the substance has been applied or laid.

In recognition of the need to limit adverse effects within the target area,

Regulations have been prescribed to restrict the use of the substance within the target area. These include a requirement to set an application rate for any substance designed for biocidal action for which an EEL has been set. The application rate must not be greater than the application rate specified in the application for approval, or not greater than a rate calculated in a similar manner to that used to calculate EELs (with the proviso that the product of the uncertainty factors must not exceed 100).

No application rates have been set at this time.

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

This Regulation applies to Fenafos 400 as it is ecotoxic to terrestrial invertebrates

(class 9.4 substances) and prescribes controls to restrict the use of Fenafos 400 in situations where they may poses a high risk to beneficial invertebrates e.g. honeybees.

Specifically, a person must not apply Fenafos 400:

 in an area where bees are foraging and the substance is in a form in which bees are likely to be exposed to it; or

 on specific plants likely to be visited by bees if the plant is in open flower or part bloom, or is likely to flower within a specified period of time following application of the substance (not longer than 10 days).

Environmental Risk Management Authority Decision: Application HSR06042 Page 15 of 27

Hazardous Substances (Identification) Regulations 2001

The Identification Regulations prescribe requirements with regard to identification of hazardous substances in terms of:

 information that must be “immediately available” with the substance

(priority and secondary identifiers). This information is generally provided by way of the product label; and

 documentation that must be available in the workplace, generally provided by way of SDS; and

 signage at a place where there is a large quantity of the substance.

I1 6, 7, 32-35,

36 (1)-(7)

General identification requirements

These controls relate to the duties of suppliers and persons in charge of Fenafos

400 with respect to identification (essentially labelling) (Regulations 6 and 7), accessibility of the required information (Regulations 32 and 33) and presentation of the required information with respect to comprehensibility, clarity and durability (Regulations 34, 35, 36(1)-(7))

Regulation 6 – Identification duties of suppliers

Suppliers of Fenafos 400 must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8-17) and secondary identifier information (as required by Regulations 18-30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling Fenafos 400 within two seconds (Regulation 32), and the secondary identifier information available within 10 seconds (Regulation 33).

Suppliers must also ensure that no information is supplied with Fenafos 400 (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to.

Regulation 7 – Identification duties of persons in charge

Persons in charge of Fenafos 400 must ensure it is labelled with all relevant priority identifier information (as required by Regulations 8 to 17) and secondary identifier information (as required by Regulations 18 to 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any person handling Fenafos 400 within two seconds (Regulation

32), and the secondary identifier information is available within 10 seconds

(Regulation 33).

Persons in charge must also ensure that no information is supplied with Fenafos

400 (or its packaging) that suggests it belongs to a class or subclass that it does not in fact belong to.

Regulations 32 and 33 – Accessibility of information

All priority identifier Information (as required by Regulations 8 to 17) must be available within two seconds , e.g. on the label

All secondary identifier Information (as required by Regulations 18 to 30) must be available within 10 seconds , e.g. on the label.

Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information

All required priority and secondary identifiers must be presented in a way that meets the performance standards in these Regulations. In summary:

 any information provided (either written or oral) must be readily understandable and in English;

 any information provided in written or pictorial form must be able to be easily read or perceived by a person with average eyesight under normal lighting conditions;

 any information provided in an audible form must be able to be easily heard

Environmental Risk Management Authority Decision: Application HSR06042 Page 16 of 27

I3

I5

I8

I9

I11

9

11

14

18

20

 by a person with average hearing; any information provided must be in a durable format i.e. the information requirements with respect to clarity must be able to be met throughout the lifetime of the (packaged) substance under the normal conditions of storage, handling and use.

Priority identifiers for ecotoxic substances

This requirement specifies that Fenafos 400 must be prominently identified as being ecotoxic.

This information must be available to any person handling the substance within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label.

Priority identifiers for flammable substances

This requirement specifies that Fenafos 400 must be prominently identified as being flammable. In addition, the following information must be provided:

 an indication that Fenafos 400 is a liquid; and

 information must be provided on its general degree of hazard ( flammable liquid: low hazard ).

This information must be available to any person handling Fenafos 400 within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label.

Priority identifiers for certain toxic substances

This requirement specifies that Fenafos 400 must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard of the substance, and the need to restrict access to the substance by children.

This information must be available to any person handling Fenafos 400 within two seconds (Regulation 32) and can be provided by way of signal headings or commonly understood pictograms on the label.

Secondary identifiers for all hazardous substances

This control relates to detail required for Fenafos 400 on the product label. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information is required:

 an indication (which may include its common name, chemical name, or registered trade name) that unequivocally identifies it; and

 enough information to enable its New Zealand importer, supplier, or manufacturer to be contacted, either in person or by telephone; and

 in the case of Fenafos 400 which, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class or subclass, a description of each likely change and the date by which it is likely to occur.

Secondary identifiers for ecotoxic substances

This control relates to the additional label detail required for Fenafos 400. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided:

 an indication of the circumstances in which it may harm living organisms; and

 an indication of the kind and extent of the harm it is likely to cause to living organisms; and

 an indication of the steps to be taken to prevent harm to living organisms; and

Environmental Risk Management Authority Decision: Application HSR06042 Page 17 of 27

I13

I16

I17

I18

I19

Regulation

22

25

26

27

29-31

 an indication of its general type and degree of hazard ( very ecotoxic in the aquatic environment, ecotoxic in the soil environment, very ecotoxic to terrestrial vertebrates, very ecotoxic to terrestrial invertebrates )

Secondary identifiers for flammable substances

This control relates to the additional label detail required for Fenafos 400. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided:

 an indication of its general type and degree of flammable hazard ( flammable liquid: low hazard ); and

 an indication of the circumstances in which it may be ignited unintentionally; and

 an indication of the likely effect of an unintentional ignition; and

 an indication of the steps to be taken to prevent an unintentional ignition.

Secondary identifiers for toxic substances

This control relates to the additional label detail required for Fenafos 400. This information must be accessible within 10 seconds (Regulation 33) and could be provided on secondary panels on the product label. The following information must be provided:

 an indication of its general type and degree of toxic hazard ( acutely toxic, mildly irritating to the skin, irritating to the eye, toxic to human target organs or systems );

 an indication of the circumstances in which it may harm human beings; and an indication of the kinds of harm it may cause to human beings, and the likely extent of each kind of harm; and

 an indication of the steps to be taken to prevent harm to human beings; and

 the name and concentration of Fenamiphos .

Use of Generic Names

This control provides the option of using a generic name to identify groups of ingredients where such ingredients are required to be listed on the product label as specified by Regulations 19(f) and 25 (e) and (f).

A generic name may also be used to identify a specific ingredient required by

Regulation 25(f) to be identified, if section 55 or section 57 of the Act applies

(withholding information on confidentiality grounds).

The generic name must identify the key chemical entities and functional groups in the ingredients that contribute to their hazardous properties.

[Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the product label, the name and concentration of Fenamiphos ].

Use of Concentration Ranges

This control provides the option of providing concentration ranges for those ingredients whose concentrations are required to be stated on the product label as specified by Regulations 19(f) and 25(e) and (f).

[Regulations 19(f) and 25(e) and (f) specify a requirement to list on the product label, the name and concentration of Fenamiphos ].

Alternative information in certain cases

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

This Regulation relates to alternative ways of presenting the priority and secondary identifier information required by Regulations 8 to 25 when Fenafos

400 is contained in fixed bulk containers or bulk transport containers.

Regulation 29(1) specifies that for fixed bulk containers, it is sufficient

Environmental Risk Management Authority Decision: Application HSR06042 Page 18 of 27

I20

I21 compliance if there is available at all times to people near the container, information that identifies the type and general degree of hazard of the substance.

When Fenafos 400 is contained, there is an additional requirement that information must be provided describing any steps to be taken to prevent an unintentional explosion, ignition combustion, acceleration of fire or thermal decomposition.

Regulation 29(2) specifies that for bulk transport containers, it is sufficient compliance if Fenafos 400 is labelled or marked in compliance with the requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or

Maritime Transport Act 1994.

Regulation 30 – Substances in multiple packaging

This Regulation relates to situations when Fenafos 400 is in multiple packaging and the outer packaging obscures some or all of the required substance information. In such cases, the outer packaging must:

 be clearly labelled with all relevant priority identifier information i.e. the hazardous properties of Fenafos 400 must be identified; or

 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; or

 bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background); or

 bear the relevant class or subclass label assigned by the UN Model

Regulations.

Regulation 31 – Alternative information when substances are imported

This Regulation relates to alternative information requirements for Fenafos 400 that is imported into New Zealand in a closed package or in a freight container and will be transported to its destination without being removed from that package or container. In these situations, it is sufficient compliance with HSNO if the package or container is labelled or marked in compliance with the requirements of the Land Transport Rule 45001.

36(8) Durability of information for class 6.1 substances

Any packaging in direct contact with Fenafos 400 must be permanently identified as having contained a toxic substance, unless the substance as packaged is restricted to a place of work.

37-39, 47-50 Documentation required in places of work

These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Safety Data Sheets)

(Regulations 37, 38 and 50); the general content requirements of the documentation (Regulation 39 and 47); the accessibility and presentation of the required documentation with respect to comprehensibility and clarity (Regulation

48).

These controls are triggered when Fenafos 400 is held in the workplace in any quantity .

Regulation 37 – Documentation duties of suppliers

A supplier must provide documentation containing all relevant information required by Regulations 39 to 48 when selling or supplying to another person any quantity of Fenafos 400, if the substance is to be used in a place of work and the supplier has not previously provided the documentation to that person.

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

The person in charge of any place of work where Fenafos 400 is present in quantities equal to or greater than those specified in Regulation 38 (and with

Environmental Risk Management Authority Decision: Application HSR06042 Page 19 of 27

I23 41 reference to Schedule 2 of the Identification Regulations), must ensure that every person handling the substance has access to the documentation required for each hazardous substance concerned. The person in charge must also ensure that the documentation does not contain any information that suggests that the substance belongs to a class or subclass it does not in fact belong to.

Regulation 39 – General content requirements for documentation

The documentation provided with Fenafos 400 must include the following information:

 the unequivocal identity of Fenafos 400 (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)); and

 a description of the physical state, colour and odour of Fenafos 400; and

 if Fenafos 400’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of the temperatures at which the changes in physical state may occur and the nature of those changes; and

 in the case of Fenafos 400 that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur; and

 contact details for the New Zealand supplier / manufacturer /importer; and

 all emergency management and disposal information required for Fenafos

400; and

 the date on which the documentation was prepared; and

 the name, concentration and CAS number of Fenamiphos .

Regulation 47 – Information not included in approval

This Regulation relates to the provision of specific documentation information

(e.g. as provided on an SDS). If information required by Regulations 39 to 46 was not included in the information used for the approval of Fenafos 400 by the

Authority, it is sufficient compliance with those Regulations if reference is made to that information requirement along with a comment indicating that such information is not applicable to Fenafos 400.

Regulation 48 – Location and presentation requirements for documentation

All required documentation must be available to a person handling Fenafos 400 in a place of work within 10 minutes . The documentation must be readily understandable by any fully-trained worker required to have access to it and must be easily read, under normal lighting conditions, at a distance of not less than

0.3m.

Regulation 49 – Documentation requirements for vehicles

This Regulation provides for the option of complying with documentation requirements as specified in the various Land, Sea and Air transport rules when

Fenafos 400 is being transported.

Regulation 50 – Documentation to be supplied on request

Notwithstanding Regulation 37 above, a supplier must provide the required documentation to any person in charge of a place of work (where Fenafos 400 is present) if asked to do so by that person.

Specific documentation requirements for ecotoxic substances

The documentation provided with Fenafos 400 must include the following information:

 its general degree and type of ecotoxic hazard ( very ecotoxic in the aquatic

Environmental Risk Management Authority Decision: Application HSR06042 Page 20 of 27

I25

I28

I29

43

46

51-52 environment, ecotoxic in the soil environment, very ecotoxic to terrestrial vertebrates, very ecotoxic to terrestrial invertebrates ); and

 a full description of the circumstances in which it may harm living organisms and the extent of that harm; and

 a full description of the steps to be taken to prevent harm to living organisms; and

 a summary of the available acute and chronic (ecotox) data used to define the

(ecotox) subclass or subclasses in which it is classified; and

 its bio-concentration factor or octanol-water partition coefficient; and

 its expected soil or water degradation rate; and

 any EELs set by the Authority.

Specific documentation requirements for flammable substances

The documentation provided with Fenafos 400 must include the following information:

 its general degree and type of hazard ( flammable liquid: low hazard) ; and

 a full description of the circumstances in which it may be ignited unintentionally; and

 the likely effect of an unintentional ignition; and

 a full description of the steps to be taken to prevent an unintentional ignition;

 and its lower and upper explosive limits, expressed as volume percentages in air or its flash point (and flash point methodology) and auto-ignition temperature.

Specific documentation requirements for toxic substances

The documentation provided with toxic substances must include the following information:

 its general degree and type of toxic hazard ( acutely toxic, mildly irritating to the skin, irritating to the eye, toxic to human target organs or systems ); and

 a full description of the circumstances in which it may harm human beings; and

 the kinds of harm it may cause to human beings; and

 a full description of the steps to be taken to prevent harm to human beings; and

 the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured; and

 a summary of the available acute and chronic (toxicity) data used to define the (toxic) subclass or subclasses in which it is classified; and

 the symptoms or signs of injury or ill health associated with each likely route of exposure; and

 the dose, concentration, or conditions of exposure likely to cause injury or ill health; and

 any TELs or WESs set by the Authority.

Duties of persons in charge of places with respect to signage

These controls specify the requirements for signage, in terms of content, presentation and positioning at places where Fenafos 400 is held in quantities exceeding 100 L .

Signs are required:

 at every entrance to the building and/or location (vehicular and pedestrian) where Fenafos 400 is present; and

 at each entrance to rooms or compartments where Fenafos 400 is present; and

 immediately adjacent to the area where Fenafos 400 is located in an outdoor area.

Environmental Risk Management Authority Decision: Application HSR06042 Page 21 of 27

I30 53

The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to:

 advise that the location contains hazardous substances; and

 describe the general type of hazard of each substance ( flammable liquid: low hazard ); and

 where the signage is immediately adjacent to the Fenafos 400 storage areas, describe the precautions needed to safely manage the substance (e.g. a 'No

Smoking' warning near Fenafos 400).

Advertising corrosive and toxic substances

Any advertisement for Fenafos 400 must include information that identifies the substance is toxic and indicates the need to restrict access by children. In addition, it must specify the general degree and type of hazard.

Hazardous Substances (Packaging) Regulations 2001

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

These controls relate to the ability of the packaging to retain its contents, allowable packaging markings with respect to design approvals, factors affecting choice of suitable packaging, and compatibility of the substance with any previous contents of the packaging.

Regulation 5 – Ability to retain contents

Packaging for Fenafos 400 must ensure that, when the package is closed, there is no visible release of the substance, and that it maintains its ability to retain its contents in temperatures from –10 o C to +50 o C. The packaging must also maintain its ability to retain its remaining contents if part of the contents is removed from the package and the packaging is then re-closed. The packaging in direct contact with Fenafos 400 must not be significantly affected or weakened by contact with the substance such that the foregoing requirements cannot be met.

Regulation 6 – Packaging markings

Packages containing Fenafos 400 must not be marked in accordance with the UN

Model Regulations unless:

 the markings comply with the relevant provisions of that document; and

 the packaging complies with the tests set out in Schedule 1, 2 or 3

(Packaging Regulations) respectively; and

 the design of the packaging has been test certified as complying with those tests.

Regulation 7(1) – Requirements when packing hazardous substance

When packing Fenafos 400, account must be taken of its physical state and properties, and packaging must be selected that complies with the requirements of Regulation 5, and Regulations 9 to 21.

Regulation 8 – Compatibility

Fenafos 400 must not be packed in packaging that has been previously packed with substances with which it is incompatible unless all traces of the previous substance have been removed.

Regulation 9A and 9B – Large Packaging

Large packaging may be used to contain Fenafos 400 in New Zealand if it has been constructed, marked and tested as a large package as provided in Chapter

6.6 of the 13 th revised edition of the UNRTDG, 2003:

“Large Packaging” does not include:

 a tank, tank wagon or transportable container (as defined in the Hazardous

Environmental Risk Management Authority Decision: Application HSR06042 Page 22 of 27

P3, P13,

P15

PG2

PS4

Substances (Tank Wagons and Transportable Containers) Regulations 2004; or

 a stationary container system, a stationary tank or a tank (as defined in the

Hazardous substances (Dangerous Goods and Scheduled Toxic Substances)

Transfer Notice 2004.

9, 19, 21 Packaging requirements for Fenafos 400

Fenafos 400 in quantities over 0.1 L must be packaged according to Schedule 2

(UN PGII), but must be packaged according to Schedule 2 or Schedule 4 when in quantities equal to or less than 0.1 L

Fenafos 400 that is offered for sale in a package of less than 2.5 L must be in child resistant packaging (i.e. toxic substances liable to be in homes). However, if the substance is for use in a place of work to which children do not have access, this requirement is not mandatory.

Schedule 2 This schedule describes the (minimum) packaging requirements that must be complied with for this substance when packaged in quantities of more than 0.1 L .

The tests in Schedule 2 correlate to the packaging requirements of UN Packing

Group II (UN PGII).

Schedule 4 This schedule describes the minimum packaging requirements that must be complied with for this substance when packaged in quantities equal to or less than 0.1 L .

Hazardous Substances (Disposal) Regulations 2001

D2, D4 and D5

6, 8 and 9 Disposal requirements for Fenafos 400

As provided by section 77(5), the disposal requirements for Fenafos 400 have been combined . This substance must be disposed of by:

 treating Fenafos 400 so that it is no longer a hazardous substance.

 exporting Fenafos 400 from New Zealand as a hazardous waste

 treatment can include controlled burning providing the performance requirements as set out in regulation 6 (3)(b) of the Disposal Regulations for protecting people and the environment are met, and the burning operation does not exceed any TELs or EELs

 treatment includes discharge into the environment as waste, or depositing in a landfill, provided the discharge location is managed so that:

- the substance will not at any time come into contact with any substances with explosive or oxidising properties, and

- there is no ignition source in the vicinity of the disposal site, and

- in the event of an accidental fire, harm to people or the environment does not occur – the performance requirements for this are set out in regulation 6 (3)(b) of the Disposal Regulations, and

- after reasonable mixing, the concentration of Fenafos 400 in any part of the environment outside the mixing zone does not exceed the TELs or

EELs set by the Authority for that substance ( see controls E1 and T1) .

However, this does not include dilution of the substance with any other substance prior to discharge to the environment

D6 10 Disposal requirements for packages

This control gives the disposal requirements for packages that contained Fenafos

400 and are no longer to be used for that purpose. Such packages must be either decontaminated/treated or rendered incapable of containing any substance

(hazardous or otherwise) and then disposed of in a manner that is consistent with the disposal requirements for the substance. In addition, the manner of disposal must take into account the material that the package is manufactured from.

D7 11, 12 Disposal information requirements

These controls relate to the provision of information concerning disposal

(essentially on the label) that must be provided when selling or supplying any quantity of Fenafos 400.

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D8 13, 14

Hazardous Substances (Emergency Management) Regulations 2001

EM1 6, 7, 9-11 Level 1 emergency management information: General requirements

These controls relate to the provision of emergency management information

(essentially on the label) that must be provided with Fenafos 400 when present in any quantity .

Regulation 6 describes the duties of suppliers, Regulation 7 describes the duties of persons in charge of places, Regulation 9 describes the requirement for the availability of the information ( 10 seconds ) and Regulation 10 gives the requirements relating to the presentation of the information with respect to comprehensibility, clarity and durability. These requirements correspond with those relating to secondary identifiers required by the Identification Regulations

(code I1, Regulations 6, 7, 32–35, 36(1)-(7)).

Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported.

EM6 8(e)

EM7 8(f)

Information requirements for toxic substances

The following information must be provided when Fenafos 400 is present in any quantity :

 a description of the first aid to be given; and

 a 24-hour emergency service telephone number.

Information requirements for ecotoxic substances

The following information must be provided with Fenafos 400 when present in quantities equal to or greater than 0.1 L :

 a description of the parts of the environment likely to be immediately affected by it; and

 a description of its typical effects on those parts of the environment; and

 a statement of any immediate actions that may be taken to prevent Fenafos

400 from entering or affecting those parts of the environment.

EM8

Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided, i.e. that would not comply with the Disposal Regulations. Such information must be accessible to a person handling the substance within 10 seconds and must comply with the requirements for comprehensibility, clarity and durability as described in Regulations 34-36 of the Identification

Regulations (code I1).

Disposal documentation requirements

These controls relate to the provision of documentation concerning disposal

(essentially in an SDS) that must be provided when selling or supplying any quantity of Fenafos 400.

The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken.

Such documentation must be accessible to a person handling the substance at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity as described in Regulations 48(2), (3) and (4) of the Identification Regulations (code I21).

12-16, 18-20 Level 2 emergency management information requirements

These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation

(essentially Safety Data Sheets). This documentation must be provided where

Fenafos 400 is sold or supplied, or held in a workplace, in any quantity .

Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes

Environmental Risk Management Authority Decision: Application HSR06042 Page 24 of 27

EM9

EM10

EM11

EM12

17

21-24

25-34

35-41 the duties of persons in charge of places of work, regulation 15 provides for the option of complying with documentation requirements of the transport rules when Fenafos 400 is being transported, and regulation 16 specifies requirements for general contents of the documentation.

Regulation 18 prescribes location and presentation requirements for the documentation, i.e. it must be available within 10 minutes , be readily understandable, comprehensible and clear. These requirements correspond with those relating to documentation required by the Identification regulations (code

I21).

Specific documentation requirements for flammable and oxidising substances and organic peroxides

There is an additional requirement for Fenafos 400 that a description be provided of the steps to be taken to control any fire involving Fenafos 400, including the types of extinguishant to be used.

Fire extinguishers

Every place (including vehicles) where Fenafos 400 is held in a place of work in quantities exceeding 500 L must have two fire extinguishers. The intention of these general requirements is to provide sufficient fire-fighting capacity to stop a fire spreading and reaching hazardous substances, rather than providing sufficient capacity to extinguish any possible fire involving large quantities of

Fenafos 400.

Each fire extinguisher must be located within 30m of the substance, or, in a transportation situation, in or on the vehicle (Regulation 22). The performance measure for an extinguisher is that it must be capable of extinguishing a fully ignited pool of flammable liquid (50mm deep and at least 6m 2 in area), before the extinguisher is exhausted, and when used by one person (Regulation 23).

Level 3 emergency management requirements – emergency response plans

These Regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where Fenafos 400 is held

(or reasonably likely to be held on occasion) in quantities greater than 100 L .

The emergency response plan must describe all of the likely emergencies that may arise from the breach or failure of controls. The type of information that is required to be included in the plan is specified in Regulations 29 to 30.

Requirements relating to the availability of equipment, materials and people are provided in Regulation 31, requirements regarding the availability of the plan are provided in Regulation 32 and requirements for testing the plan are described in

Regulation 33.

Level 3 emergency management requirements – secondary containment

These Regulations relate to the requirement for a secondary containment system to be installed at any fixed location where Fenafos 400 is held in quantities equal to or greater than 100 L .

Regulation 36 prescribes requirements for secondary containment systems for pooling substances. Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60

L or less. Regulation 38 prescribes requirements for places where hazardous substances are held above ground in containers each holding between 60 L and

450 L. Regulation 39 prescribes requirements for places where hazardous substances are held above ground in containers each holding more than 450 L.

Regulation 40 prescribes requirements for places where hazardous substances are held underground. Regulation 41 prescribes requirements for secondary containment systems that contain substances of specific hazard classifications, e.g. there is a requirement to prevent substances from coming into contact with

Environmental Risk Management Authority Decision: Application HSR06042 Page 25 of 27

incompatible materials, and a requirement to exclude energy sources when class

1, 2, 3, 4 or 5 substances are contained).

The following subclauses shall be 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.

EM13 42

(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.

Level 3 emergency management requirements – signage

This control relates to the provision of emergency management information on signage at places where Fenafos 400 is held in quantities equal to or greater than

100 L .

The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in

Regulations 34 and 35 of the Identification Regulations.

Hazardous Substances (Personnel Qualification) Regulations 2001

AH1 4-6 Approved Handler requirements

Fenafos 400 is required to be under the control of an approved handler during specified parts of the lifecycle. An approved handler is a person who holds a current test certificate certifying that they have met the competency requirements specified by the Personnel Qualification Regulations in relation to handling specific hazardous substances.

Regulation 4 describes the test certification requirements, regulation 5 describes the qualification (competency and skill) requirements and regulation 6 describes situations where transitional qualifications for approved handlers apply.

See Controls T6 and E7

Hazardous Substances (Tracking) Regulations 2001

TR1 4(1), 5, 6 General tracking requirements

Fenafos 400 is subject to tracking requirements, i.e. the location and movement of Fenafos 400 must be recorded at each stage of its lifecycle until its final disposal. The hazard classifications of Fenafos 400 requiring tracking are listed in Schedule 1 of the Tracking Regulations [Regulation 4(1)].

The person in charge of the place where Fenafos 400 is kept is responsible for ensuring that the necessary information is included in the record. This information to be provided is specified in Schedule 2 of the Tracking

Regulations, and includes information on the identification of the approved handler, and on the identification, quantity, location and disposal of the substance. The record must meet the location and presentation requirements specified in Part 2 of the Identification Regulations, i.e. it must be accessible within 10 minutes and meet the performance standards for comprehensibility and clarity [Regulation 5(1) and (2)].

If Fenafos 400 is transferred to another place, the person in charge must ensure

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that the record is retained for a period of 12 months. If Fenafos 400 has undergone treatment that results in it no longer being a tracked substance, or if it has been intentionally or unintentionally disposed of, the record must be kept for

3 years. However these requirements do not apply to places that are vehicles.

[Regulation 5(3) and (4)].

Regulation 6 prescribes requirements relating to the transfer of Fenafos 400 from one place to another. Specifically, the person in charge may only transfer

Fenafos 400 to another place if they have received confirmation that:

 an approved handler is present at the place receiving Fenafos 400;

 the place receiving Fenafos 400 meets any location test certification requirements;

 any place where Fenafos 400 is to be held during transit complies with the relevant requirements of the Hazardous Substances (Emergency

Management) Regulations and Hazardous Substances (Classes 1 to 5

Controls) Regulations.

Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004

Regulations 4 to 43 The Hazardous Substances (Tank Wagons and Transportable Containers) where applicable Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers and must be complied with as relevant.

Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notices

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

March 2004 the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)

Transfer Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October 2004 and by Issue No. 208, 16 December 2005), shall apply to this substance, notwithstanding clause 1(1) of that schedule.

Schedule 9, DGTN

March 2004

Schedule 10, DGTN

March 2004

The controls relating to secondary containment, as set out in Schedule 9 of the

Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)

Transfer Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October 2004 and by Issue No. 208, 16 December 2005), shall apply to this substance, notwithstanding clause 1(1) of that schedule.

The controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances, set out in Schedule 10 of the Hazardous

Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice

(New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No.

128, 1 October 2004 and by Issue No. 208, 16 December 2005), shall apply to this substance, notwithstanding clause 1 of that schedule.

Additional Controls Under Section 77A

Fenafos 400 must not be applied directly onto or into water.

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