Amended under s67A on 18 December 2006
ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
16 May 2006
Application code
HSR06044
Application type
To import or manufacture any hazardous substance under Section
28A(2)(a) of the Hazardous Substances and New Organisms
(HSNO) Act 1996
Applicant
Zelam Ltd
PO Box 7142
NEW PLYMOUTH
Applicant contact:
Chris Hayward
Purpose
Tnl 2040: to manufacture a capsule suspension containing 250 g/L
of bupirimate for control of powdery mildew on apples, pumpkins
and squash for domestic and export consumption (rapid similar)
Date received
1 May 2006
Consideration date
16 May 2006
Considered by
Rob Forlong (Chief Executive, ERMA New Zealand)
1
Summary of Decision
1.1
The application to import or manufacture Tnl 2040 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.
1.2
The substance has been given the following unique identifier for the ERMA New Zealand
Hazardous Substances Register:
Tnl 2040
1.3
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:
3
1
39
Wide Dispersive Use
Agriculture Industry
Pesticides
2
Legislative Criteria for Application
2.1
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.
2.2
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.
3
Application Process
3.1
The purpose of the application is to seek approval to manufacture Tnl 2040 for the control
of powdery mildew on apples, pumpkins and squash for domestic and export
consumption.
3.2
The application was formally received on 1 May 2006.
3.3
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)).
3.4
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.”
3.5
Project Team:
Margaret Keane
Applications Advisor (Hazardous Substances)
Laura Docker
Science Advisor (Hazardous Substances)
Report review and sign-out by:
Dr Peter Dawson
4
Principal Scientist (Hazardous Substances)
Consideration
Sequence of the Consideration
4.1
Zelam Ltd seeks approval under section 28A(2)(a) of the HSNO Act to import or
manufacture Tnl 2040.
4.2
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 HSR06044
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4.3
The approach adopted when considering this application was:
 To identify the composition and hazardous properties of the proposed substance,
Tnl 2040, and of the “reference” similar substance identified by Zelam Ltd;
 To determine whether Tnl 2040 has a similar composition and similar hazardous
properties to the reference substance nominated or another reference substance.
4.4
And then:
 To determine whether Tnl 2040 has a similar life-cycle to the reference substance;
 To consider whether the risks posed by Tnl 2040 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 Tnl 2040 should
not be rapidly assessed; and
 To consider whether the controls that apply under the HSNO Act to the reference
substance are applicable to Tnl 2040.
Information Review
4.5
I have reviewed the information supplied by Zelam 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).
Composition of Tnl 2040 Relative to that of the Reference Substance
4.6
Zelam Ltd identified a reference substance against which Tnl 2040 should be compared as
a fungicide which was approved as a Part V Application under the HSNO Act on
8 October 2003 and given the ERMA Approval Code HSR000080.
4.7
After considering Zelam Ltd’s nominated reference substance and other potential
reference substances, I consider that there is a valid approved reference substance against
which Tnl 2040 can be compared.
4.8
Both Tnl 2040 and the reference substance contain bupirimate at approximately the same
concentrations. Other excipients differ; however, the concentration of major hazardous
components in Tnl 2040 is less than that of the reference substance.
4.9
The reference substance is a suspension concentrate, whereas Tnl 2040 is an encapsulated
suspension. Encapsulation is a process whereby the active ingredient in the formulation is
enclosed in a microscopic polymeric shell, which forms a suspension in an aqueous
solution. It is considered that the risks of an encapsulated suspension are less than the risks
posed by a suspension concentrate due to the reduced human exposure to the hazardous
components. Consequently, the Agency considers that the difference in physical form is
not considered to contravene the criteria of the ERMA NZ Policy Series, Rapid
Assessment (ER-PO-HS-01 10/4) for similarity of physical form.
4.10
After taking the variations in composition into account, I have concluded that the
compositions of Tnl 2040 and the reference substance are of the same nature and kind.
Therefore, I am satisfied that Tnl 2040 has a similar composition to the reference
substance.
Hazardous Properties of Tnl 2040 Relative to the Reference Substance
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4.11
Zelam Ltd has provided information related to the hazardous properties of Tnl 2040.
4.12
Under section 28A(2)(a), Tnl 2040 must have similar hazardous properties to the
reference substance. The hazardous properties of Tnl 2040 and the reference substance are
listed below:
Hazard Endpoint
Skin irritancy
Eye irritancy
Contact sensitisation
Target organ systemic toxicity
Aquatic ecotoxicity
4.13
Tnl 2040
6.3B
6.4A
6.5B
6.9B
9.1A
Reference
Substance
6.3B
6.4A
6.5B
6.9B
9.1A
The hazard profile of Tnl 2040 is the same as 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
4.14
I consider that, based on the application submitted by Zelam 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)
4.15
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 Tnl 2040;
 New Zealand’s international obligations.
5
Life-cycle, Risks and Controls
5.1
Tnl 2040 is a fungicide for the control of powdery mildew in apples, pumpkins and export
squash. It is a new formulation that reduces plant phyto-toxicity and is safer for handling
as a concentrate than the currently registered water emulsion (EW) and suspension
concentrate (SC) forms. This formulation is more stable and by encapsulating the active
ingredient, the risk of skin and eye irritation and skin sensitisation is significantly reduced.
5.2
Tnl 2040 will be manufactured at Zelam Ltd’s site in New Plymouth. This facility has ISO
9001 and PRINCE® GOLD accreditation for the manufacturing and handling of
chemicals. Quality control systems have been put in place for the control of dust, spillage
and wash-waters.
Environmental Risk Management Authority Decision: Application HSR06044
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5.3
No waste substance is allowed to leave the site but is treated on-site, as per the waste
management system.
5.4
Staff have received the appropriate training for handling of the raw materials and all safety
data sheets, production techniques and safety controls are available at all times.
5.5
Storage on-site is within the confines of Zelam Ltd’s fully bunded area where any
inadvertent spillage is prevented from entering the city’s storm-water system or the
environment via the soil or run-off.
5.6
Containers for packaging the substance are UN Approved HDPE jerry cans with tamper
evident lids, sizes ranging from 1 - 20 L (HDPE Spec UN3HI/Y/1-4/100), and 110, 200,
or 1,000 L bulk containers (HDPE UN Spec 1H1/Y/1.4/100; AUS 20244). These are
shrink-wrapped onto pallets for easy movement and storage. Storage at retailer /
agricultural distributor stores will be on standardised racking; placarded and controlled
within the requirements of the HSNO Act.
5.7
Where possible Tnl 2040 will be shipped on pallets. To ship individual 20 L containers,
they are covered with a plastic sleeve (leaving the handle exposed) to protect the label and
safety instructions.
5.8
1, 5 and 10 L containers are packed in cardboard outers and accompanied with the
required transport documents.
5.9
Transport is by approved carriers with the correct placarding for the hazard class of this
product and accompanied by product safety data sheets.
5.10
The application rates and methods of application for TNL 2040 and the reference
substance are similar. TNL 2040 is to be applied at a rate of 40 – 50 mL / 100 L water to
apples, and 800 mL – 1 L / ha to field grown pumpkin and winter squash. The applicant
states that the reference substance has the same application rate as TNL 2040.
5.11
If the product is used in the manner intended, there will be little to dispose of. However, if
large volumes require disposal, it is recommended that the local council be contacted for
options to send to an approved land fill. Empty containers will be triple rinsed and either
burnt (weather permitting) or crushed and buried in an approved landfill.
5.12
Taking into account the similar uses of Tnl 2040 and the reference substance, I consider
that the risks associated with the use of Tnl 2040 will be no greater than those of the
reference substance.
5.13
I note that there are no other matters (section 6) that would prevent this application for
Tnl 2040 from being approved by rapid assessment.
5.14
I therefore consider that, given the similarities in composition, hazard properties and the
risks associated with the life-cycle, the controls as applied to the reference substance are
equally applicable to Tnl 2040 with the following variations:
Additional Controls under Section 77A
5.15
The following controls are applicable to Tnl 2040 under section 77A:
5.16
“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,
Environmental Risk Management Authority Decision: Application HSR06044
Page 5 of 20
1 October 2004 and by Issue No. 208, 16 December 2005), shall apply to this substance,
notwithstanding clause 1(1) of the schedule.”
5.17
I note that, as a means of managing the risks from Tnl 2040, 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).
5.18
These additional controls are applied to the reference substance and I consider them to be
equally applicable to Tnl 2040.
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 Tnl 2040, the above sub-clauses are
necessary. 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 Tnl 2040.
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 Tnl
2040 is not approved for such use, the following control is applied to Tnl 2040:
Tnl 2040 must not be applied directly onto or into water.
Exposure Limits for substances with toxic or ecotoxic properties under
Section 77B
5.21
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 Tnl 2040 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).
Environmental Risk Management Authority Decision: Application HSR06044
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5.22
Control code E2 relates to the setting of application rates. The application rates and
methods of application for TNL 2040 and the reference substance are similar. Tnl 2040 is
to be applied at a rate of 40 – 50 mL / 100 L water to apples and 800 mL – 1 L / ha to field
grown pumpkin and winter squash. Application rates are set for Tnl 2040 as follows:
Apples: 40 – 50 mL / 100 L water
Field grown pumpkin and winter squash: 800 mL – 1 L / ha
5.23
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 Tnl 2040.
5.24
Control code T2 relates to controlling exposure in places of work through the setting of
WESs. 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 for the reference substance, as applicable. It is
noted that the Department of Labour has set a WES for Component B at TWA 150 ppm,
474 mg/m3 (vapour and particulates) and 10 mg/m3 (particulates only). However, this
component is only present at a low level in Tnl 2040, and therefore this WES is not
considered appropriate for Tnl 2040, therefore none have been set.
Variation of Controls under Section 77
5.25
The Approved Handler controls AH1 and E7 have been deleted for the reference
substance, and for consistency have been deleted as requirements for Tnl 2040.
5.26
Tracking control TR1 has been deleted to be consistent with the reference substance. This
practice is based on Authority Policy (November 2003) by which tracking controls
triggered solely by ecotoxic hazards may be deleted.
5.27
Control codes T4 and E6 are combined under section 77(5) as they both relate to
requirements for equipment used to handle Tnl 2040.
5.28
Controls P3, P13 and P15 have been combined under section 77(5) as they all relate to
packaging requirements for Tnl 2040.
5.29
Control codes D4 and D5 have been combined under section 77(5) as they both relate to
disposal requirements for Tnl 2040.
5.30
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)).
5.31
The list of controls for Tnl 2040 is detailed in Appendix 1.
6
Environmental User Charges
6.1
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
Environmental Risk Management Authority Decision: Application HSR06044
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any environmental user charge, or a combination of an environmental user charge and
controls.
6.2
I consider that the use of controls is the most effective means of managing the risks
throughout the life cycle of Tnl 2040. The imposition of an environmental user charge
instead of, or in combination with controls, is therefore not required at this time.
7
Decision
7.1
Having considered the composition and hazardous properties for Tnl 2040, 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.
7.2
In considering Tnl 2040 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.
7.3
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 Tnl 2040.
7.4
The application is accordingly approved pursuant to section 28A(2)(a) of the HSNO Act
with controls as listed in Appendix 1.
Rob Forlong
Date
16 May 2006
Chief Executive, ERMA New Zealand
ERMA New Zealand Approval code:
Tnl 2040
Environmental Risk Management Authority Decision: Application HSR06044
HSR002483
Page 8 of 20
Amendment December 2006
(a)
Addition of a s77A control stating:
Tnl 2040 must not be applied directly onto or into water
___________________________________
Rob Forlong
Chief Executive
18 December 2006
___________________
Date
Environmental Risk Management Authority Decision: Application HSR06044
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Appendix 1: Controls Applying to Tnl 2040
The controls imposed on Tnl 2040 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 Regulation2 Explanation3
Code1
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 Tnl 2040 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.
No TELs are set at this time for Tnl 2040.
T2
29, 30
Controlling exposure in places of work
A workplace exposure standard (WES) is designed to protect persons in the
workplace from the adverse effects of Tnl 2040. A WES is an airborne
concentration of a substance (expressed as mg substance/m3 of air or ppm in air),
which must not be exceeded in a workplace and applies to every place of work.
No WESs are set at this time for Tnl 2040.
T4, E6
7
Requirements for equipment used to handle hazardous substances
Any equipment used to handle Tnl 2040 (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.
T5
8
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when Tnl 2040 is being handled.
The clothing/equipment must be designed, constructed and operated to ensure that
the person does not come into contact with Tnl 2040 and is not directly exposed to a
concentration of Tnl 2040 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.
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.
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T7
10
Restrictions on the carriage of hazardous substances on passenger service
vehicles
In order to limit the potential for public exposure to Tnl 2040, the maximum
quantity per package permitted to be carried on passenger service vehicles must is
0.1 L.
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).
E2
E5
46-48
5(2), 6
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.
No EELs are set at this time for Tnl 2040.
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 Tnl 2040 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).
Application rates are set for Tnl 2040 as follows:
Apples: 40 – 50 mL / 100 L water
Field grown pumpkin and winter squash: 800 mL – 1 L / ha
Requirements for keeping records of use
A person using Tnl 2040 for the purposes of causing biocidal action must keep
written records of that use if 3 kg or more of Tnl 2040 is applied within 24 hours in
an area where Tnl 2040 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.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to identification
of Tnl 2040 in terms of:
 information that must be “immediately available” with Tnl 2040 (priority and
secondary identifiers). This information is generally provided by way of the
product label;
 documentation that must be available in the workplace, generally provided by
way of SDS;
 signage at a place where there is a large quantity of Tnl 2040.
I1
6, 7, 32-35,
General identification requirements
36 (1)-(7)
These controls relate to the duties of suppliers and persons in charge of Tnl 2040
with respect to identification (essentially labelling) (Regulations 6 and 7),
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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 Tnl 2040 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 Tnl 2040 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 Tnl 2040 (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 Tnl 2040 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 Tnl 2040 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 Tnl 2040 (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.
I3
I9
9
18
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 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) Tnl 2040 under the normal conditions of storage,
handling and use.
Priority identifiers for ecotoxic substances
This requirement specifies that Tnl 2040 must be prominently identified as being
ecotoxic.
This information must be available to any person handling Tnl 2040 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 Tnl 2040 on the product label. This
information must be accessible within 10 seconds (Regulation 33) and could be
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I11
20
I16
25
I17
26
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 Tnl 2040 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 Tnl 2040. 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;
 an indication of the kind and extent of the harm it is likely to cause to living
organisms;
 an indication of the steps to be taken to prevent harm to living organisms;
 an indication of its general type and degree of hazard (very ecotoxic in the
aquatic environment).
Secondary identifiers for toxic substances
This control relates to the additional label detail required for Tnl 2040. 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 (mildly irritating to
the skin, mildly irritating to the eye, contact sensitiser, harmful to human
target organs or systems);
 an indication of the circumstances in which it may harm human beings;
 an indication of the kinds of harm it may cause to human beings, and the likely
extent of each kind of harm;
 an indication of the steps to be taken to prevent harm to human beings;
 the name and concentration of Bupirimate.
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.
I18
27
[Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the product
label, the name and concentration of Bupirimate].
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 Bupirimate].
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I19
29-31
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 Tnl 2040 is contained
in fixed bulk containers or bulk transport containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient compliance
if there is available at all times to people near the container, information that
identifies the type and general degree of hazard of Tnl 2040.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if the substance 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 Tnl 2040 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 Tnl 2040 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.
I21
37-39, 47-50
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for Tnl 2040 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.
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 Tnl 2040 is held in the workplace in quantities
equal to or greater than 1.0 L.
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 a quantity of
Tnl 2040 equal to or greater than 1.0 L, if Tnl 2040 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 Tnl 2040 is present in quantities
equal to or greater than those specified in Regulation 38 (and with reference to
Schedule 2 of the Identification Regulations), must ensure that every person
handling Tnl 2040 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.
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Regulation 39 – General content requirements for documentation
The documentation provided with Tnl 2040 must include the following information:
 the unequivocal identity of Tnl 2040 (e.g. the CAS number, chemical name,
common name, UN number, registered trade name(s));
 a description of the physical state, colour and odour of Tnl 2040;
 if the Tnl 2040’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;
 in the case of Tnl 2040 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;
 contact details for the New Zealand supplier / manufacturer /importer;
 all emergency management and disposal information required for the substance;
 the date on which the documentation was prepared;
 the name, concentration and CAS number of Bupirimate.
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 Tnl 2040 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 Tnl 2040.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling Tnl 2040 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 Tnl
2040 is being transported.
I23
41
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 Tnl 2040 is
present) if asked to do so by that person.
Specific documentation requirements for ecotoxic substances
The documentation provided with Tnl 2040 must include the following information:
 its general degree and type of ecotoxic hazard (very ecotoxic in the aquatic
environment);
 a full description of the circumstances in which it may harm living organisms
and the extent of that harm;
 a full description of the steps to be taken to prevent harm to living organisms;
 a summary of the available acute and chronic (ecotox) data used to define the
(ecotox) subclass or subclasses in which it is classified;
 its bio-concentration factor or octanol-water partition coefficient;
 its expected soil or water degradation rate;
 any EELs set by the Authority.
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I28
46
I29
51-52
Specific documentation requirements for toxic substances
The documentation provided with Tnl 2040 must include the following information:
 its general degree and type of toxic hazard (mildly irritating to the skin,
mildly irritating to the eye, contact sensitiser, harmful to human target
organs or systems);
 a full description of the circumstances in which it may harm human beings;
 the kinds of harm it may cause to human beings;
 a full description of the steps to be taken to prevent harm to human beings;
 the percentage of volatile substance in the liquid formulation, and the
temperature at which the percentages were measured;
 a summary of the available acute and chronic (toxicity) data used to define the
(toxic) subclass or subclasses in which it is classified;
 the symptoms or signs of injury or ill health associated with each likely route of
exposure;
 the dose, concentration, or conditions of exposure likely to cause injury or ill
health;
 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 Tnl 2040 is held in quantities
exceeding 100 L.
Signs are required:
 at every entrance to the building and/or location (vehicular and pedestrian)
where Tnl 2040 is present
 at each entrance to rooms or compartments where Tnl 2040 is present;
 immediately adjacent to the area where Tnl 2040 is located in an outdoor area.
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;
 describe the general type of hazard of each substance (e.g. flammable);
 where the signage is immediately adjacent to the Tnl 2040 storage areas,
describe the precautions needed to safely manage Tnl 2040 (e.g. a 'No Smoking'
warning near flammable substances).
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 Tnl 2040 with any previous contents of the
packaging.
Regulation 5 – Ability to retain contents
Packaging for Tnl 2040 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 –10oC to +50oC. 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 Tnl 2040
must not be significantly affected or weakened by contact with Tnl 2040 such that
the foregoing requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing Tnl 2040 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
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
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 Tnl 2040, 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.
P3, P13,
P15
9, 19, 21
Regulation 8 – Compatibility
Tnl 2040 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 Tnl 2040 in New Zealand if it has been
constructed, marked and tested as a large package as provided in Chapter 6.6 of the
13th revised edition of the UNRTDG, 2003.
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the Hazardous
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.
Packaging requirements for Tnl 2040
Tnl 2040 in quantities over 5.0 L must be packaged according to Schedule 3 (UN
PGIII), but must be packaged according to Schedule 3 or Schedule 4 when in
quantities equal to or less than 5.0 L
Tnl 2040 that is offered for sale in a package of less than 2.5 L must be in child
resistant packaging (i.e. Tnl 2040 liable to be in homes). However, if Tnl 2040 is for
use in a place of work to which children do not have access, this requirement is not
mandatory.
PG3
Schedule 3
This schedule describes the (minimum) packaging requirements that must be
complied with for Tnl 2040 when packaged in quantities of more than 5.0 L. The
tests in Schedule 3 correlate to the packaging requirements of UN Packing Group III
(UN PGIII).
PS4
Schedule 4
This schedule describes the minimum packaging requirements that must be
complied with for Tnl 2040 when packaged in quantities equal to or less than 5.0 L.
Hazardous Substances (Disposal) Regulations 2001
D2, D4
6, 8 and 9
Disposal requirements for Tnl 2040
and D5
As provided by section 77(5), the disposal requirements for toxic and ecotoxic
substances have been combined. Tnl 2040 must be disposed of by:
 treating Tnl 2040 so that it is no longer a hazardous substance.
 exporting Tnl 2040 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:
- Tnl 2040 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
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- after reasonable mixing, the concentration of Tnl 2040 in any part of the
D6
10
D7
11, 12
D8
13, 14
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 Tnl 2040 with any other substance prior to
discharge to the environment
Disposal requirements for packages
This control gives the disposal requirements for packages that contained Tnl 2040
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 Tnl 2040. In addition, the manner of disposal must take
into account the material that the package is manufactured from.
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 a quantity
of Tnl 2040 that exceeds 0.1 L.
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 Tnl 2040 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 a quantity
of Tnl 2040 that exceeds 1.0 L.
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 Tnl 2040 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).
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 Tnl 2040 when present in
quantities equal to or greater than 0.1 L.
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)).
EM6
8(e)
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when Tnl 2040 is being transported.
Information requirements for toxic substances
The following information must be provided when Tnl 2040 is present in quantities
equal to or greater than 0.1 L:
 a description of the first aid to be given;
 a 24-hour emergency service telephone number.
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EM7
8(f)
EM8
12-16, 18-20
Information requirements for ecotoxic substances
The following information must be provided with Tnl 2040 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;
 a description of its typical effects on those parts of the environment;
 a statement of any immediate actions that may be taken to prevent Tnl 2040
from entering or affecting those parts of the environment.
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 Tnl
2040 is sold or supplied, or held in a workplace, in quantities equal to or greater
than 1.0 L.
Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes 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 Tnl
2040 is being transported, and regulation 16 specifies requirements for general
contents of the documentation.
EM11
EM12
25-34
35-41
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).
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 Tnl 2040 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 Tnl 2040 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 Tnl
2040 is held above ground in containers each holding up to 60 L or less. Regulation
38 prescribes requirements for places where Tnl 2040 is held above ground in
containers each holding between 60 L and 450 L. Regulation 39 prescribes
requirements for places where Tnl 2040 is held above ground in containers each
holding more than 450 L. Regulation 40 prescribes requirements for places where
Tnl 2040 is held underground. Regulation 41 prescribes requirements for secondary
containment systems that contain Tnl 2040, e.g. there is a requirement to prevent
Tnl 2040 from coming into contact with incompatible materials).
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
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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.
EM13
42
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management information on
signage at places where Tnl 2040 is held at 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 (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 the
March 2004
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 Tnl 2040, notwithstanding clause 1(1) of that schedule.
Additional Controls Under Section 77A
Tnl 2040 must not be applied directly onto or into water.
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