ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
30 June 2016
Application code
HSR02029
Application type
To import or manufacture any hazardous substance under Section
28 of the Hazardous Substances and New Organisms (HSNO) Act
1996
Applicant
Virbac Laboratories NZ Limited
Purpose
To import for release an endectocide (VBPOC) for use on
production animals
Date received
17 June 2002
Consideration date
17 September 2002
Date decision signed
7 October 2002
Considered by
Hazardous Substances Standing Committee of the Authority
1
Summary of Decision
1.1
The application to import VBPOC is approved with controls in accordance with
the relevant provisions of the Hazardous Substances and New Organisms Act 1996
(the HSNO Act), the HSNO Regulations, and the HSNO (Methodology) Order 1998.
Although the applicant proposes only to import the substance, this approval
authorises both import and manufacture.
1.2
The substance has been given the unique identifier “VBPOC” for the purposes of the
ERMA New Zealand Hazardous Substances Register.
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
3
Non-dispersive
Industry Category
1
Agricultural industry
Use Category
41
Pharmaceuticals, subcategory
– veterinary medicine
Environmental Risk Management Authority Decision: Application HSR02029
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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 29, taking into account additional matters
to be considered in that section and matters relevant to the purpose of the 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 Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology).
Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3
Application Process
3.1
The application was formally received on 17 June 2002, and verified on 25 June
2002.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(b) and 7, public
notification was made on 29 June 2002.
3.3
Submissions closed on 9 August 2002. No submissions were received (section 54,
clause 5), and a public hearing was not held.
3.4
Various government departments (including MAF, OSH and MOH), Crown Entities
and interested parties, which in the opinion of the Authority would be likely to have
an interest in the application, were notified of the receipt of the application (sections
53(4) and 58(c), and clauses 2(e) and 5) and provided with an opportunity to
comment or make a public submission on the application.
3.5
The New Zealand Food Safety Authority (NZFSA) stated that they were unable to
comment due to the fact that very little relevant information was contained in the
application. They specifically noted the complete lack of formulation details.
3.6
The Ministry of Health commented that they were concerned that the applicant is
wishing to place the product on the market without identifying publicly the active
ingredient. The Ministry considered such an approach to be unacceptable. They
stated that as far as they were aware such a product would have identified the active
ingredient pre-HSNO, except when it was undergoing non-commercial (not for
production) field testing. As they did not know the identity of the active ingredient,
they had no other comments to make. They further noted that there is a potential for
the product to give rise to meat residues, and that they assumed that the application
under the Agricultural Compounds and Veterinary Medicines (ACVM) Act would
address any residue issues and establish maximum residue limits for its use if
necessary.
3.7
Fish and Game New Zealand (Eastern Region) stated that they did not consider that
the substance poses any threats to fresh water sports fish or game birds, or their
habitats, and therefore did not wish to consult or make a submission.
Environmental Risk Management Authority Decision: Application HSR02029
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3.8
Environment Waikato commented that the confidentiality of formulation details
made it impossible to make an educated comment on the application. They further
stated that seeking wider consultation seems a little pointless, and in such cases
either ERMA New Zealand should not consult widely or it should require disclosure
of the active ingredient.
3.9
No external experts were used in the considering of this application (clause 17).
3.10
Members of the Hazardous Substances Standing Committee: Tony Haggerty
(Chairperson), George Clark and Lindie Nelson considered the application (section
19(2)(b)).
3.11
The information available to the Committee comprised:



4
The application
Confidential information supplied with the previous containment application,
HSC02001
The ERMA New Zealand Evaluation and Review (E&R) Report
Consideration
Purpose of the Application
4.1
The application is to import for release an endectocide (VBPOC) for use on
production animals.
4.2
VBPOC is a topical endectocide proposed for use in the treatment of internal and
external parasites in production animals, including cattle and deer. It contains the
active ingredient ivermectin at a concentration of 0.5% w/v. It is to be used by
veterinarians and those handling production animals, and is administered topically
through the use of a purpose-built applicator.
4.3
VBPOC is a generic reproduction of a product that was originally licensed in New
Zealand in 1988 under the Animal Remedies Act. This product has been widely used
by New Zealand farmers for the last 14 years. The applicant states that formulations
identical to this one are already approved for use in the New Zealand market under
the Animal Remedies Act, but have not been assessed under the HSNO process.
4.4
The applicant proposes to import VBPOC from Australia either by air or sea. It will
be imported in plastic lidded containers as follows: 500mL containers in cartons of
10, 1L containers in cartons of 10, 2.5L containers in cartons of 4 and 5L containers
in cartons of 4. It will be temporarily stored at the airport or the wharf before being
transported to the Virbac warehouse. There it will be stored in a secure facility
before being transported to wholesalers and veterinary clinics, who will store it until
it is sold to the end user. It will then be transported to the application area where it
may be used immediately or stored for later use. Disposal instructions and
recommendations will be cited on the label.
Environmental Risk Management Authority Decision: Application HSR02029
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Sequence of the Consideration
4.5





In accordance with clause 24, the approach adopted by the Committee was to:
Establish the hazard classifications for the substance and derive the default
controls.
Identify potentially non-negligible risks, costs, and benefits.
Assess potentially non-negligible risks, costs, and benefits in the context of the
default controls and possible variations to those controls. Risks were assessed in
accordance with clause 12, and costs and benefits in accordance with clause 13.
Consider and determine variations to the default controls arising from the
circumstances provided for in sections 77 (3), (4) and (5) and then consolidate
controls.
Evaluate overall risks, costs, and benefits to reach a decision. The combined impact
of risks, costs and benefits was evaluated in accordance with clause 34, and the
cost-effectiveness of the application of controls was considered in accordance with
clause 35.
Hazard Classification
4.6
The applicant stated that ERMA NZ has formally classified the substance as a result
of an application (HSC02001) for import into containment, and included that
classification in their application. The Committee agreed with the hazard
classification, and classified VBPOC as follows:

3.1B
Flammable liquid

6.1D
Acute oral toxicity

6.1B
Acute inhalation toxicity

6.3B
Skin irritation

6.4A
Eye irritation

6.8B
Reproductive/Developmental effects

6.9A
Target organ systemic effects

9.1A
Aquatic effects

9.2B
Soil ecotoxicity

9.3A
Terrestrial vertebrate toxicity

9.4A
Terrestrial invertebrate toxicity
Environmental Risk Management Authority Decision: Application HSR02029
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Default Controls
4.7
The Committee considered that the E&R Report correctly assigned default controls
as set out in the HSNO Regulations. They were used as the reference for subsequent
consideration of the application. The default controls are identified in the E&R
Report (at section 6.4) and are not reproduced here.
Identification of the Significant Risks, Costs and Benefits of the Substance
4.8
The Committee identified potentially non-negligible risks, costs and benefits with
reference to clauses 9 and 11, which incorporate relevant material from sections 2, 5,
6, and 8.
Risks
4.9
The Committee reviewed the identification of risks made by the applicant and
additional risks identified in the E&R Report. From all of these risks, the
Committee identified those summarised in the table below as those which were
potentially non-negligible and thus warranted more detailed assessment.
Lifecycle Activity and associated source of risk
Risks Arising
Transport
Risk to workers and general public from
inhalation, ingestion, skin or eye contact.
Transport accident leads to spill; includes transport
from airport/wharf to Virbac warehouse, from
there to wholesaler or veterinary clinic, and from
there to end user.
Risk to environment (aquatic ecosystems, soil
ecosystems, terrestrial vertebrates and
invertebrates).
The flammable component is a fire hazard when
exposed to heat, flame or oxidisers.
Storage
Damage to packaging leading to spill at
airport/wharf, Virbac warehouse, wholesaler,
veterinary clinic or end users’ premises.
Risk to workers and general public from
inhalation, ingestion, skin or eye contact.
Risk to environment (aquatic ecosystems, soil
ecosystems, terrestrial vertebrates and
invertebrates).
The flammable component is a fire hazard when
exposed to heat, flame or oxidisers.
Use
End user exposure resulting from failure to follow
safety precautions and instructions for use.
Risk to workers from inhalation, ingestion, skin or
eye contact.
Risk to environment (aquatic ecosystems, soil
ecosystems, terrestrial vertebrates and
invertebrates).
The flammable component is a fire hazard when
exposed to heat, flame or oxidisers.
Disposal
Risk to workers and general public from
inhalation, ingestion, skin or eye contact.
Environmental Risk Management Authority Decision: Application HSR02029
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Lifecycle Activity and associated source of risk
Risks Arising
Incorrect disposal of the substance.
Risk to environment (aquatic ecosystems, soil
ecosystems, terrestrial vertebrates and
invertebrates).
The flammable component is a fire hazard when
exposed to heat, flame or oxidisers.
4.10
Neither the applicant nor the E&R Report identified any risks to Māori, in relation to
section 6(d) especially or more broadly. The application had been referred to
ERMA New Zealand’s Senior Maori Advisor on behalf of Ngā Kaihautū Tikanga
Taiao. The Committee concludes that there are negligible risks to Māori.
Costs
4.11
A “cost” is defined in regulation 2 of the Methodology as “the value of a particular
adverse effect expressed in monetary or non-monetary terms”. The Methodology
and the Act both call for consideration of monetary and non-monetary costs (clause
13 and section 9).
4.12
In relation to the costs of effects identified in the above table, the Committee
considered that the following costs were potentially non-negligible:
 Costs arising from adverse effects on people from accidental spillage at any
stage of the life cycle;

4.13
Costs associated with a spill, clean-up and disposal
There appear to be no new costs associated with use of this substance in New
Zealand. It is a generic reproduction of a product originally licensed in New
Zealand in 1988 under the Animal Remedies Act. The applicant states that the
original product has been widely used since then without reports of significant
adverse incidents or environmental impacts, but this has not been verified.
Benefits
4.14
A “benefit” is defined in regulation 2 of the Methodology as “the value of a
particular positive effect expressed in monetary or non-monetary terms”. Benefits
that may arise from any of the matters set out in clauses 9 and 11 were considered in
terms of clause 13.
4.15
For this substance, the Committee considered that benefits are in terms of the
availability of another product in the marketplace. This will create competition, and
may lead to reduced prices and thus an increased treatment rate.
Environmental Risk Management Authority Decision: Application HSR02029
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Assessment of the Potentially Non-negligible Risks of the Substance
4.16
The risks assessed were those identified as potentially non-negligible. Risks were
considered in terms of the requirements of clause 12, including the assessment of
consequences and probabilities, the impact of uncertainty and the impact of risk
management.
4.17
The evidence available was largely scientific in nature and was considered in terms
of clause 25(1). This evidence comprised that provided by the applicant and
additional evidence set out in the E&R Report.
4.18
In assessing risk, the Committee gave particular consideration to risks arising from
the significant hazards of the substance i.e. flammability, toxicity and ecotoxicity,
and examined the extent to which exposure to hazard would be mitigated by controls
(clauses 11 and 12).
Assessment of Risks to Human Health from Spillage
4.19
The substance is highly flammable, an acute oral toxicant, an acute inhalation
toxicant, a skin irritant, an eye irritant, has reproductive/developmental effects and
target organ systemic effects (clause 12(a)).
4.20
Accidental spillage can occur at any stage of the life cycle with the possibility of
skin or eye contact, inhalation, or ingestion causing adverse effects on human health.
It may be a fire hazard if it is exposed to heat, flames or oxidising agents. With the
controls in place in the storage and transport situations, the likelihood of adverse
effects to human health is unlikely, and the magnitude of effect is considered
minimal. The likelihood of any particular transport accident involving dangerous
goods and this particular substance is very unlikely and the magnitude of effect is
considered minimal. It is considered unlikely that adverse effects to human health
would occur, and the magnitude of effect is considered to be minimal with the
controls in place (clause 12(b)). The Committee considered the overall risk to
human health from spillage of VBPOC to be insignificant (clause 12(c)).
Assessment of Risks to the Biological and Physical Environment from Spillage
4.21
The substance is highly flammable, a soil ecotoxicant, a terrestrial vertebrate
toxicant and a terrestrial invertebrate toxicant (clause 12(a)).
4.22
Accidental spillage during transport or storage may result in discharge to soil and /
or waterways, potentially affecting soil ecosystems, terrestrial vertebrates and
terrestrial invertebrates. It may be a fire hazard if it is exposed to heat, flames or
oxidising agents. In the storage situation, it is likely that any spills will be contained
within the premises involved, and therefore discharge to the environment is very
unlikely, with the effects considered to be minimal. In the transport situation, the
size of containers and the amount transported at any one time will limit the amount
released. With the controls in place, the likelihood of an adverse effect to the
biological or physical environment is considered to be very unlikely and the
Environmental Risk Management Authority Decision: Application HSR02029
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magnitude of effect is considered to be minimal (clause 12(b)). The Committee
considered the risk to the biological and physical environment from spillage to be
insignificant (clause 12(c)).
Assessment of Risks to Human Health During Use
4.23
The substance is highly flammable, an acute oral toxicant, an acute inhalation
toxicant, a skin irritant, an eye irritant, has reproductive/developmental effects and
target organ systemic effects (clause 12(a)).
4.24
In the use situation, the end user will remove the cap from the container as supplied,
and replace it with a cap that has dispensing attachments immediately prior to
administering it to the animals. No decanting of the substance is necessary. With
the controls in place, the possibility of adverse effects to human health is considered
to be very unlikely, and the magnitude of any adverse to be minimal (clause 12(b)).
The Committee considered this risk to be insignificant (clause 12(c)).
Assessment of Risks to Biological and Physical Environment During Use
4.25
The substance is highly flammable, a soil ecotoxicant, a terrestrial vertebrate
toxicant and a terrestrial invertebrate toxicant (clause 12(a)).
4.26
Accidental discharge to the environment during use is considered to be very
unlikely, as the substance is administered directly to the animals topically with the
use of a purpose-built applicator. With the controls in place, the likelihood of an
adverse effect to the biological or physical environment is considered to be very
unlikely and the magnitude of effect is considered to be minimal (clause 12(b)). The
Committee considered this risk to be insignificant (clause 12(c)).
Assessment of Risk from Disposal
4.27
With respect to human health, the substance is an acute oral toxicant, an acute
inhalation toxicant, a skin irritant, an eye irritant, has reproductive/developmental
effects and target organ systemic effects. With respect to the biological and physical
environment, the substance is highly flammable, a soil ecotoxicant, a terrestrial
vertebrate toxicant and a terrestrial invertebrate toxicant (clause 12(a)).
4.28
Situations where there is a need to dispose of VBPOC could occur following
spillage during the life cycle, or in disposal of old stock that is past its expiry date
(although good stock management and the influence of cost should decrease the
need for disposal of old stock). The need to dispose of a significant amount of the
substance, such as through a major spill in a traffic accident, is considered very
unlikely, and the magnitude of effects to be minimal. With the controls in place, it
was considered unlikely that the disposal of VBPOC would result in adverse effects
to the biological or physical environment, or to human health. In the event of an
exposure, the magnitude of effect is considered to be minimal (clause 12(b)). The
Committee considered this risk to be insignificant (clause 12(c)).
Environmental Risk Management Authority Decision: Application HSR02029
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Assessment of the Potentially Non-negligible Costs and Benefits
4.29
The Methodology and the Act both call for consideration of monetary and nonmonetary costs (clause 13 and section 9). The potentially non-negligible costs are
discussed in 4.11- 4.13. The Committee was satisfied that that there are no
significant costs that will result from the release of VBPOC.
4.30
The potentially non-negligible benefits are discussed in 4.14 – 4.15. The magnitude
of the benefits of releasing VBPOC depends largely on the degree to which this
product will affect the endectocide market. The Committee was unable to place an
expected value on the benefits (clause 13(b)) but was satisfied that the ability of the
applicant to enter the market will give rise to the associated benefits.
Establishment of the Approach to Risk in the Light of Risk Characteristics
4.31
Clause 33 requires the Authority to have regard for the extent to which a specified
set of risk characteristics exist when considering applications. The intention of this
provision is to provide a route for determining how cautious or risk averse the
Authority should be in weighing up risks and costs against benefits.
4.32
The Committee considered that the risks involved in this application were all
negligible with the controls in place, therefore the risk characteristics were not
further analysed to establish an approach to risk.
Overall Evaluation of Risks, Costs and Benefits
4.33
Having regard to clauses 22 and 34 and in accordance with the tests in clause 26 and
section 29, risks costs and benefits were evaluated taking account of all proposed
controls including default controls plus proposed variations to the controls.
4.34
Clause 34 sets out the approaches available to the Authority in evaluating the
combined impact of risks costs and benefits i.e. weighing up risks, costs and
benefits.
4.35
The Committee considered that the risks, with the controls in place, were
cumulatively negligible.
4.36
In accordance with clause 26, where a substance poses negligible risks to the
environment and to human health and safety, the Authority may approve a substance
if it is evident that the benefits associated with the substance outweigh the costs. It
was evident in this case that the benefits do outweigh the costs.
Variation of Controls under Section 77
4.37
Under section 77(3), (4) and (5), the default controls determined by the hazardous
properties of the substance may be varied.
Environmental Risk Management Authority Decision: Application HSR02029
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4.38
Controls F2, T7 and T8 relate to restrictions on the carriage of hazardous substances
on passenger service vehicles. The Committee noted that these may be combined
under section 77(5) and apply at the lower level of 0.1 L.
4.39
Controls F4, T6, E7, and AH1 relate to approved handler requirements. The
Committee agreed with the E&R Report that the controls can be modified under
section 77(4)(b) so that they do not apply to the end user when quantities of 20L or
less of the substance are held, and the substance is used as a pour-on insecticide.
4.40
Control T1 relates to limiting exposure to toxic substances. The Committee agreed
with the E&R Report that a requirement to set a TEL has not been activated and this
control is therefore not invoked.
4.41
Control E1 relates to limiting exposure to ecotoxic substances. In the E&R report
(paras 6.4.5.12, 6.4.5.13), the Maximum Allowable Concentration value set by the
UK Department of Environment, Transport and Regions (DETR) was proposed for
adoption as the EELfreshwater for ivermectin. However, the DETR have set both
Maximum Allowable Concentration and Annual Average Values, reflecting both
acute and chronic effects. Therefore the chronic exposure values should be adopted
in line with the EEL framework in the Regulations. The international values of
EELfreshwater =0.0000001 mg/L and EELmarine =0.000001 mg/L are therefore adopted
as environmental exposure limits for ivermectin. The Committee agreed with the
E&R report that EELs should not be set for other media.
4.42
Control E2 relates to restrictions on use within the application area. The Committee
agreed with the E&R Report that the application rate for ivermectin must not exceed
the dose regime of 1mL of VBPOC per 10kg of live weight, or the value set
subsequently under the ACVM Act.
4.43
Control E3 relates to the protection of terrestrial invertebrates. The Committee
agreed with the E&R Report that this control may be deleted under section 77(4)(a)
as the adverse effects are less than the adverse effects which would usually be
associated with substances given a 9.4A classification.
4.44
Control E4 relates to the protection of terrestrial vertebrates. The Committee agreed
with the E&R Report that this control is not invoked, as VBPOC is not a substance
that will be, and is not likely to be, intentionally released into the environment in
granular form or coated on seeds for pest control.
4.45
Controls E5 and T3 relate to the requirements for keeping records of use. The
Committee agreed with the E&R Report that these controls may be deleted under
section 77(4)(a) as the adverse effects are less than the adverse effects usually
associated with substances given these classifications.
4.46
The Committee agreed with the proposals in the E&R Report that the following
controls should be combined as provided for by section 77(5). The Committee’s
view was that the combined controls resulting from these combinations will control
all of the adverse effects identified for the substance.
Environmental Risk Management Authority Decision: Application HSR02029
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





Controls I3, I5, I8: Hazardous Substances (Identification) Regulations 2001
Regulations 9, 11 &13 – Priority Identifiers
Controls I9, I11, I13, I16: Hazardous Substances (Identification) Regulations
2001 Regulations 18, 20, 22 & 25 – Secondary Identifiers
Controls I23, I25, I28: Hazardous Substances (Identification) Regulations
2001 Regulations 41, 43 & 46 – Documentation Requirements
Controls P3, P5, P13, P15: Hazardous Substances (Packaging) Regulations
2001 Regulations 9, 11, 19 & 21 – Packaging Requirements
Controls D2, D4, D5: Hazardous Substances (Disposal) Regulations 2001
Regulations 6, 8 & 9 – Disposal Requirements
Controls EM1, EM4, EM6, EM7: Hazardous Substances (Emergency
Management) Regulations 2001 Regulations 6, 7, 8(c), 8(e),8(f), 9, 10, 11 –
Emergency Management Information Requirements
4.47
The Committee noted that Regulations 8(e) and (f) of the Emergency Management
Regulations refer to these regulations applying to toxic and ecotoxic substances and
makes reference to Schedule 1 of the Emergency Management Regulations.
However, there is no reference in Schedule 1 to toxic or ecotoxic substances. As
indicated in the E&R report this omission is due to an error in printing of the
Regulations and Schedule 1 was intended to apply to substances in category 6.1B in
any amount. The relevant control has thus not been set. However, the Committee
strongly recommended that the applicant provide the appropriate emergency
management information on the label or in some other accessible form for any
amount of VBPOC.
4.48
Control TR1 relates to general tracking requirements. The Committee agreed with
the E&R Report that this control may be deleted under section 77(4)(a) as the
adverse effects identified for VBPOC are less than the adverse effects which would
usually be associated with substances of this classification.
4.49
Prior to the Committee’s consideration, the E&R Report that proposed the above
variations to controls was provided to the applicant for comment. The applicant’s
comments were taken into consideration by the Committee. The provisions of clause
35(b) are effectively met. The controls are thus varied accordingly. The Committee
noted that ERMA New Zealand staff will follow-up with the applicant on comments
made on the proposed controls.
Environmental User Charges
4.50
In the current absence of comprehensive criteria for undertaking such a
consideration, no consideration has been given to whether or not environmental user
charges should be applied to the substance which is the subject of this approval.
Environmental Risk Management Authority Decision: Application HSR02029
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5
Decision
5.1
Pursuant to section 29 of the Act, the Committee has considered this application to
import a hazardous substance made under section 28 of the Act.
5.2
Having considered all the possible effects of the hazardous substance in accordance
with section 29 of the Act, pursuant to clause 26 of the Methodology, based on
consideration and analysis of the information provided, and taking into account the
application of controls, the view of the Committee is that the substance poses
negligible risks to the environment and to human health and safety, and it is evident
that the benefits associated with the substance outweigh the costs.
5.3
In accordance with clause 36(2)(b) of the Methodology the Committee records that,
in reaching this conclusion, it has applied the balancing tests in section 29 of the Act
and clause 26 of the Methodology.
5.4
It has also applied the following criteria in the Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 21 – the decision accords with the requirements of the Act and
regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques;
 clause 25 – the evaluation of risks;
 clause 26 - risks are negligible and costs are outweighed by benefits;
 clause 33 – risk characteristics;
 clause 34 – the aggregation and comparison of risks, costs and benefits; and
 clause 35 – the costs and benefits of varying the default controls.
5.5
The application for importation and manufacture of the hazardous substance
VBPOC is thus approved, with controls as detailed in Appendix 1.
Mr Tony Haggerty
Chair Hazardous Substances Committee
Environmental Risk Management Authority Decision: Application HSR02029
Date 7th October 2002
Page 12 of 34
APPENDIX 1 – Controls Applying to the Substance
Control
Code1
Regulation2
Explanation3
Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001 – Flammable Property Controls
F1
Regulation 7
General test certification requirements for VBPOC
Where a test certificate is required for a hazardous substance location where
flammable substances are held, that test certificate must be issued by an
approved test certifier and must typically be renewed yearly. However, the
Authority can, on request by the persons required to obtain the test
certificate, extend the time period to 3 years.
F2, T7,
E8
Regulations 8,
10
General public transportation restrictions and requirements for
VBPOC
For VBPOC, the quantity permitted to be carried on a passenger service
vehicle is 0.1 L or less.
F3
Regulation 55
General limits on VBPOC
Where VBPOC is present at a place for longer than the specified times
listed below, and in a quantity that exceeds the levels specified in Table 4 of
Schedule 3 (Classes 1 to 5 Controls Regulations), that substance must be
held at a hazardous substance location (or transit depot as appropriate).
 18 hours if the substance is not subject to tracking requirements

2 hours if the substance is subject to tracking requirements (ie
class 3.1A, 3.2A, 4.1.2A, 4.1.2B, 4.1.3A, 4.2A, 4.3A).
For VBPOC, as a Class 3.1B substance packaged in closed containers, this
requirement is triggered by a quantity exceeding 100 L and periods longer
than 18 hours.
F4
Regulation 56
Certain flammable substances to be under the control of an approved
handler
When certain class 2, 3 or 4 substances are held in quantities above the
amounts specified in Table 2 of Schedule 3 (Classes 1 to 5 Controls
Regulations), they must be under the control of an approved handler or
secured to a specified standard.
It should be noted that any person handling any quantity of a class 2.1.1,
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 ERMA New Zealand and is also contained in the ERMA New
Zealand User Guide to the Controls 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 HSR02029
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2.1.2 or 3.1 substance under any of regulations 61, 63(4), 65, 67 and 69
must be an approved handler for that substance, ie the trigger quantities that
typically activate approved handler requirements do not apply [Regulation
60(2)].
For VBPOC, as a Class 3.1B substance, this means that the approved
handler requirement is activated by any amount.
It is considered that the adverse effects identified as a pour-on insecticide
for the end user of VBPOC are less than would usually be associated with
substances given this hazard classification and therefore this control does
not apply to the end user where quantities of 20 L or less of VBPOC is held.
F5
Regulations
58-59
Requirements regarding hazardous atmosphere zones for VBPOC
There is a requirement to establish a hazardous atmosphere zone wherever
class 2.1.1A, 2.1.1B, 2.1.2A, 3.1A, 3.1B or 3.1C substances are present in
quantities greater than those specified in Table 3 of Schedule 3 (Classes 1 to
5 Controls Regulations). The zone must comply with either of the standards
as listed in regulation 58 (a)-(b) or an ERMA approved code of practice.
There are a number of requirements that must be met regarding hazardous
atmosphere zones, including:
 any controls placed on electrical systems or electrical equipment
within a hazardous atmosphere zone must be consistent with any
controls on electrical systems or electrical equipment set under
other legislation that are relevant to that specific location. This is
to ensure that any potential ignition sources from electrical
system or electrical equipment are protected or insulated to an
extent that is consistent with the degree of hazard [Regulation 59]

test certification requirements [Regulation 81].
For VBPOC this requirement is activated by amounts in excess of 100 L.
F6
Regulations
60-70
Requirements to prevent unintended ignition of VBPOC
These regulations prescribe controls to reduce the likelihood of unintended
ignition of flammable gases, aerosols and liquids. 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 (eg 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,
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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, eg 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
Regulation 76
Segregation of incompatible substances
In order to reduce the likelihood of unintended ignition of flammable
substances, there is a requirement to ensure that the substance does not
come into contact with any incompatible substance or material, eg by
keeping class 4.2 substances away from air and by keeping class 4.3
substances away from water. A list of substances and materials considered
incompatible with class 2, 3 and 4 substances is provided in Table 1 of
Schedule 3 (Classes 1 to 5 Controls Regulations).
F12
Regulations
77-78
General requirement for hazardous substance locations for VBPOC
There is a requirement to establish a hazardous substance location where
any class 2, 3 or 4 substance is present in quantities greater than those
specified in Table 4 of Schedule 3 (Classes 1 to 5 Controls Regulations)
and for a period exceeding either 18 hours (for substances that do not
require tracking) or 2 hours (for substances that are subject to the Tracking
Regulations).
Within such zones, there is a requirement for the person in charge to:
 notify the responsible enforcement authority of the locality and
capacity of the hazardous substance location

where relevant, ensure that the substances will be under the
control of an approved handler and that any container/building
used to hold the substances is secured

ensure that any test certification requirements are met

ensure that a site plan is available for inspection

where required, establish and manage a hazardous atmosphere
zone
A number of controls are prescribed for hazardous substance locations in
order to reduce the likelihood of unintended ignition of class 2, 3 or 4
substances [Reg 78], including:
 requirements for fire resistant walls (240/240/240 minutes) and
separation distances (greater than 3 m) to isolate any ignition
sources

safety requirements for electrical equipment (construction, design,
earthing)
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 requirements for segregation of incompatible substances
For VBPOC, this requirement is triggered by a quantity exceeding 100 L
and periods longer than 18 hours.
F14
Regulation 81
Test certification requirements for facilities where VBPOC is present
There is a test certification requirement when class 2.1.1, 2.1.2 or 3.1
substances are present at any hazardous substance location, hazardous
atmosphere zone or transit depot when in quantities above the amounts
specified in Tables 3 and 4 of Schedule 3, (Classes 1 to 5 Controls
Regulations).
That test certificate must be issued by an approved test certifier and must
demonstrate compliance with a number of specified controls, including:
 notification to relevant enforcement officer of hazardous
substance location

approved handler requirements

security requirements

hazardous atmosphere zone requirements, including controls on
electrical systems and electrical equipment

segregation of incompatible substances

signage requirements

emergency management requirements

fire-fighting equipment

secondary containment
For VBPOC, this requirement is triggered by a quantity exceeding 100 L.
F16
Regulation 83
Controls on transit depots where VBPOC is present
Transit depots are places designed to hold hazardous substances (in
containers that remain unopened) for a period of up to 3 days, but for
periods that are more than:
 18 hours (for substances that do not require tracking) or

2 hours (for substances that are subject to the Tracking
Regulations)
Whenever any class 2, 3 or 4 substance is held at a transit depot in
quantities exceeding the levels specified in Table 4 of Schedule 3 (Classes 1
to 5 Controls Regulations), there is a requirement for the person in charge
to:
 notify the responsible enforcement authority of the locality and
capacity of the hazardous substance location

where relevant, ensure that the substances will be under the
control of an approved handler
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 ensure that any road vehicle loaded with containers of class 2, 3
or 4 substances is within specified distances of other vehicles or
places containing hazardous substances

ensure that containers of class 2, 3 or 4 substances held in the
depot (but not loaded onto a vehicle) are within specified
distances from vehicles or other containers

ensure that all class 2, 3 or 4 substances remain in their containers
and the containers remain closed

ensure the safety of any electrical equipment

comply with any signage requirements

comply with relevant parts of other Acts and Regulations, eg
Electricity Act 1992, HSE (Mining Underground Regulations)
1999 or Civil Aviation Rules
For VBPOC, this requirement is triggered by a quantity exceeding 100 L
and periods longer than 18 hours.
F17
Regulations
84-85
Requirements to control adverse effects of intended ignition of
VBPOC, including requirements for protective equipment and clothing
These controls are intended to ensure that where VBPOC is intentionally
burnt, the effects of combustion are managed:
 to ensure that adverse effects are contained within the intended
area, and

to prevent people being exposed to harmful levels of heat
radiation.
Reg 84(1) prescribes controls relating to the maximum level of heat
radiation that a person may be exposed to whenever VBPOC is
intentionally burnt. If the intended combustion involves burning substances
at a rate in excess of 20 kg/hour or 20 L/hour, there is an additional
requirement for the person in charge to establish a combustion zone around
the intended combustion area [Reg 84(2)]. The person in charge of the
combustion zone must ensure that:
 the enforcement officer has been notified of the combustion
zone’s location

the combustion zone encompasses all areas where there is the
potential for people to be exposed to a higher degree of heat
radiation than the level specified in Reg 84(1)(b)

a site plan of the combustion zone is available at all times

all non-authorised personnel are excluded from the combustion
zone

the level of heat radiation outside the combustion zone at no
exceeds the level specified in Reg 84(1)(b)

there is appropriate signage around the perimeter of the zone
warning that combustion is occurring and prohibiting entry into
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the zone.
For those situations where the level of heat radiation within a combustion
zone may exceed the level specified in Reg 84(1)(b), there is a requirement
for the person in charge to ensure that all people entering the combustion
zone have the appropriate protective clothing and equipment [Reg 85].
Specific requirements are prescribed relating to the design, construction and
use of the protective clothing and equipment, including:
 they must be designed, constructed and operated to prevent any
person being subjected to more than the level of heat radiation
specified in Reg 84(1)(b)

they must either be constructed of materials that are not degraded,
attacked or combusted by the substance under the expected use
conditions, or if they are not completely resistant, they must retain
their integrity for the time specified by the supplier.

they must be accompanied by documentation that gives sufficient
instruction on their use and maintenance.
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 – Toxic Property Controls
T2
Regulations
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 toxic substances. A WES is an
airborne concentration of a substance (expressed as mg substance/m3 of air
or ppm in air), which must not be exceeded in a workplace and only apply
to places of work that the public does not have access to.
For VBPOC, the WES is set for isopropanol at 400ppm (983 mg/m3)
T4
Regulation 7
Requirements for equipment used to handle VBPOC
Any equipment used to handle VBPOC (eg spray equipment) must retain
and/or dispense the substance in the manner intended, ie without leakage,
and must be accompanied by sufficient information so that this can be
achieved.
T5
Regulation 8
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when VBPOC is being
handled. The clothing/equipment must be designed, constructed and
operated to ensure that the person does not come into contact with the
substance 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.
T6
Regulation 9
Approved handler requirements
Where hazardous substances of classification 6.1A, 6.1B, 6.1C or 8.2A are
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held or used in any quantity or 6.7A substances are held or used in
quantities equal or greater than 10 kg or 10 L, the substances must generally
be under the personal control of an approved handler, or locked up.
However, such substances 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
It is considered that the adverse effects identified as a pour-on insecticide
for the end user of VBPOC are less than would usually be associated with
substances given this hazard classification and therefore this control does
not apply to the end user where quantities of 20 L or less of VBPOC is held.
T8
Regulation 28
Controls on Vertebrate Poisons
This regulation applies to class 6.1 substances that are (lawfully) laid or
applied outdoors for vertebrate pest control. Requirements are prescribed to
limit the likelihood of such substances from coming into contact with
members of the general public and off-target species in places of public
access.
The person in charge of laying or applying the bait must erect warning signs
at every normal entry point to the place at least 3 days prior to the bait being
applied or laid. The signs must:
 identify (and supply a contact number) of the person applying or
laying the substance

identify the substance and state that it is toxic and ecotoxic

state the date on which the substance is being applied or laid

ensure that that the sign complies with regulations 51 – 53 of the
Identification Regulations (signage requirements)

The signs must remain in place until:

the substance has either been removed

enough time has elapsed that the substance is no longer hazardous

a specified period of time has elapsed (as approved by the
Authority in the application)
The requirement for the substance to be under the control of an approved
handler or secured (T6, Regulation 9) can be waived once the bait has been
applied or laid.
It is noted that VBPOC is not a substance that is intended to be “(lawfully)”
laid or applied outdoors for vertebrate pest control. This control is therefore
unlikely to have any effect on the applicant’s proposed use of VBPOC as a
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veterinary medicine.
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 – Ecotoxic Property Controls
E1
Regulations
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 (eg soil
or sediment or water), including deposition of a substance onto surfaces (eg
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
The international values of EELfreshwater =0.0000001 mg/L and
EELmarine=0.000001mg/L are set as environmental exposure limits for
ivermectin.
E2
Regulations
46-48
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 (eg
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.
The application rate for ivermectin must not exceed the dose regime of 1mL
of VBPOC per 10kg of live weight, or the value set subsequently under the
ACVM Act.
E6
Regulation 7
Requirements for equipment used to handle VBPOC
Any equipment used to handle VBPOC (eg spray equipment) must retain
and/or dispense the substance in the manner intended, ie without leakage,
and must be accompanied by sufficient information so that this can be
achieved.
E7
Regulation 9
Approved handler requirements
Where ecotoxic substances of any hazard classification 9.1A, 9.2A, 9.3A or
9.4A are held in any quantity, the substances must generally be under the
personal control of an approved handler at all times, or locked up. However,
such substances may be handled by a person who is not an approved
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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
It is considered that the adverse effects identified as a pour-on insecticide
for the end user of VBPOC are less than would usually be associated with
substances given this hazard classification and therefore this control does
not apply to the end user where quantities of 20 L or less of VBPOC is
held.
Hazardous Substances (Identification) Regulations 2001
I1
Regulations 6,
7, 32-35, 36
(1)-(7)
General identification requirements
These controls relate to the duties of suppliers and persons in charge of
VBPOC with respect to identification (essentially labelling) (Regs 6 and 7),
accessibility of the required information (Regs 32 and 33) and presentation
of the required information with respect to comprehensibility, clarity and
durability (Regs 34, 35, 36(1)-(7)).
Regulation 6 – Identification duties of suppliers
Suppliers of VBPOC must ensure it is labelled with all relevant priority
identifier information (as required by Regs 8 - 17) and secondary identifier
information (as required by Regs 18 - 30) before supplying it to any other
person. This includes ensuring that the priority identifier information is
available to any person handling the substance within 2 seconds (Reg 32),
and the secondary identifier information available within 10 seconds (Reg
33).
Suppliers must also ensure that no information is supplied with VBPOC (or
its packaging) that suggests it belongs to a class that it does not in fact
belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of VBPOC must ensure it is labelled with all relevant
priority identifier information (as required by Regs 8 - 17) and secondary
identifier information (as required by Regs 18 - 30) before supplying it to
any other person. This includes ensuring that the priority identifier
information is available to any person handling the substance within 2
seconds (Reg 32), and the secondary identifier information available within
10 seconds (Reg 33).
Persons in charge must also ensure that no information is supplied with
VBPOC (or its packaging) that suggests it belongs to a class that it does not
in fact belong to.
Regulations 32 and 33 – Accessibility of information
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All priority identifier information (as required by Regs 8 - 17) must be
available within 2 seconds, eg. on the label.
All secondary identifier information (as required by Regs 18 - 30) must be
available within 10 seconds, eg. 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 and oral) must be readily
understandable and in English
I3, I5, I8
Regulation 9,
11, 13

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, ie 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 VBPOC
This requirement specifies that ecotoxic, flammable and toxic substances
must be prominently identified as being ecotoxic, flammable and toxic. In
addition, information must be provided on the general degree and type of
hazard of the substance (eg highly poisonous), and the need to restrict
access to the substance by children. Further, the following information
must be provided:
 an indication of whether the substance is a gas, aerosol, liquid or
solid

if a flammable liquid, information must be provided on its general
degree of hazard (eg highly flammable)

if a flammable solid, information must be provided on its general
type of hazard (eg dangerous when wet)
This information must be available to any person handling the substance
within two seconds (Reg 32) and can be provided by way of signal
headings or commonly understood pictograms on the label.
I9, I11,
I13, I16
Regulation 18,
20, 22, 25
Secondary identifiers for VBPOC
This control relates to detail required for VBPOC on the product label. This
information must be accessible within 10 seconds (Reg 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,
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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 a substance 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, a description of each likely change and the date by
which it is likely to occur.

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

in the case of an ecotoxic substance of classification 9.1A, 9.1B
or 9.1C, an indication of its general type and degree of hazard (eg
very toxic to aquatic life)

in the case of an ecotoxic substance of classification 9.2A, 9.2B
or 9.2C, 9.3A, 9.3B, 9.4A, 9.4B or 9.4C, an indication of its
general type of hazard (eg ecotoxic to terrestrial invertebrates)
These requirements could be addressed by statements on the label
with respect to its action against both target and off-target organisms
and the method of application used to avoid exposure to off-target
organisms. A statement should be included warning against incorrect
disposal in sensitive environments.

an indication of its general type and degree of flammable hazard
(eg highly flammable liquid)

an indication of the circumstances in which it may be ignited
unintentionally

an indication of the likely effect of an unintentional ignition

an indication of the steps to be taken to prevent an unintentional
ignition

an indication of its general type and degree of toxic hazard (eg
mild skin irritant)

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 any ingredient that would
independently of any other ingredient, cause the substance to be
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classified as either a class 6.1A, 6.1B, 6.1C, 6.5, 6.6, 6.7, 6.8 or
6.9

I17
Regulation 26
the name of any ingredient that would, independently of any other
ingredient, cause the substance to be classified as a 6.1D. In
addition, the concentration of the ingredient that would contribute
the most to that classification must be provided.
Use of Generic Names
This control provides the option of using a generic name to identify specific
ingredients (or 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).
[Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the
product label, the name and concentration of any ingredient that would
independently of any other ingredient, cause the substance to be classified
as either 6.1A, 6.1B, 6.1C, 6.1D, 6.5, 6.6, 6.7, 6.8, 6.9, 8.2 or 8.3].
I18
Regulation 27
Requirements for using 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 any ingredient that would
independently of any other ingredient, cause the substance to be classified
as either 6.1A, 6.1B, 6.1C, 6.1D, 6.5, 6.6, 6.7, 6.8, 6.9, 8.2 or 8.3].
I19
Regulations
29-31
Alternative information in certain cases
Regulation 29 – VBPOC 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 – 25 when
VBPOC 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 the
substance. When class 1, 2, 3, 4 or 5 substances are 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 the substance is labelled or marked in compliance with the
requirements of either the Land Transport Rule 45001, Civil Aviation Act
1990 or Maritime Transport Act 1994.
It is noted that VBPOC will not be contained in fixed bulk containers or
bulk transport containers.
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Regulation 30 – Substances in multiple packaging
This regulation relates to situations when VBPOC 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
ie the hazardous properties of the substance 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

in the case of an ecotoxic substance, it must bear the EU
pictogram “Dangerous to the Environment” (‘dead fish and tree’
on orange background), or

bear the relevant class label assigned by the UN Model
Regulations
Regulation 31 – Alternative information when substances are imported
This regulation relates to alternative information requirements for VBPOC
when it is imported into New Zealand in a closed package or in a freight
container and will be transported to their 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.
I20
I21
Regulation
36(8)
Durability of information for VBPOC
Regulations 37
-39, 47-50
Documentation required in places of work
Any packaging in direct contact with VBPOC must be permanently
identified as having contained a toxic substance, unless as packaged it is
restricted to a place 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
Material Safety Data Sheets) (Regs 37, 38 and 50); the general content
requirements of the documentation (Regs 39 and 47); the accessibility and
presentation of the required documentation with respect to
comprehensibility and clarity (Reg 48). Where a substance triggers more
than one hazard classification, the most stringent quantity generally applies.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by regulations 39 – 46 when selling or supplying any amount of
VBPOC to another person, 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
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The person in charge of any place of work where any amount of VBPOC is
present, must ensure that every person handling the substance has access to
the documentation containing all relevant information required by
regulations 39 – 46.
The person in charge must also ensure that the documentation does not
contain any information that suggests the substance has hazardous
properties it does not have.
Regulation 39 – General content requirements for documentation
The documentation provided with VBPOC must include the following
information:
 the unequivocal identity of the substance (eg the CAS number,
chemical name, common name, UN number, registered trade
name(s))

a description of the physical state, colour and odour of the
substance

if the substance’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 a substance 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 or
importer

all emergency management and disposal information required for
the substance

the date on which the documentation was prepared

the name and concentration of any ingredients that would
independently of any other ingredient, cause the substance to be
classified as either a class 6.1A, 6.1B, 6.1C, 6.5, 6.6, 6.7, 6.8,6.9,
8.2 or 8.3. For VBPOC, this will require identification of
isopropanol.
Regulation 48 – Location and presentation requirements for
documentation
All required documentation must be available to a person handling the
substance 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
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Regulation2
Explanation3
This regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance 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 VBPOC
is present) if asked to do so by that person.
This control applies to any amount of VBPOC.
I23, I25,
I28
Regulation 41,
43, 46
Specific documentation requirements for VBPOC
The documentation provided with VBPOC must include the following
information:
 its general degree and type of ecotoxic hazard (eg highly ecotoxic
to terrestrial vertebrates)

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

the EEL set for ivermectin

its general degree and type of flammability hazard

a full description of the circumstances in which it may be ignited
unintentionally

the likely effect of an unintentional ignition

a full description of the steps to be taken to prevent an
unintentional ignition

if it is a gas, its lower and upper explosive limits, expressed as
volume percentages in air

if it is a liquid, its lower and upper explosive limits, expressed as
volume percentages in air or its flash point (and flash point
methodology) and auto-ignition temperature

if it is a self-reactive solid, its self-acceleration decomposition
temperature and heat of decomposition per unit mass

its general degree and type of toxic hazard

a full description of the circumstances in which it may harm
human beings
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Control
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I29
Regulation2
Regulations
51-52
Explanation3
 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

if it is a gas or an aerosol, its vapour pressure, and the temperature
at which that pressure was measured

if it will be a liquid during its use, 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 (toxic) 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

the WES set for isopropanol
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 VBPOC is held in quantities
exceeding those specified in Schedule 3 of the Identification Regulations.
Where a substance triggers more than one hazard classification, the most
stringent quantity generally applies.
For VBPOC, this trigger quantity is 100 L.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where hazardous substances are present

at each entrance to rooms or compartments where hazardous
substances are present

immediately adjacent to the area where hazardous substances are
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
I30
Regulation 53

describe the general type and degree of hazard of the substance
(eg highly flammable)

where the signage is immediately adjacent to the hazardous
substance storage areas, describe the precautions needed to safely
manage the substance (eg a 'No Smoking' warning near
flammable substances).
Advertising VBPOC
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Control
Code1
Regulation2
Explanation3
Any advertisements for a class 6 substance must provide information
identifying that it is toxic, specifying the degree of toxicity and the need to
restrict access by children.
Hazardous Substances (Packaging) Regulations 2001
P1
Regulations 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 VBPOC 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 VBPOC 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 VBPOC 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 3 (Packaging Regulations) and the design of the packaging
has been test certified as complying with those tests.
Regulation 7(1) – Requirements when packing VBPOC
When packing VBPOC, 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 – 21.
Regulation 8 – Compatibility
VBPOC must not be packed in packaging that has been previously packed
with substances with which it is incompatible.
P3, P5,
P13, P15
Regulation 9,
11, 19, 21
Packaging requirements for VBPOC
For VBPOC, the packaging requirements are that it must be packaged
according to Schedule 2 (UN PGII) when in quantities exceeding 0.1 L per
package, but may be packed according to Schedule 4 when in quantities
equal to or less than 0.1 L per package.
Also, VBPOC in packages of less than 2.5 L must be in child-resistant
packaging unless it is to be used in a place of work to which children do not
have access.
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Regulation2
Explanation3
PG2
Schedule 2
This schedule provides the test methods for packaging required to be tested
in accordance with this schedule. The tests in Schedule 2 correlate to the
packaging requirements of UN Packaging Group II.
Hazardous Substances (Disposal) Regulations 2001
D2, D4,
D5
Regulation 6,
8, 9
Disposal requirements for VBPOC
Flammable (class 2, 3 and 4) substances must be disposed of by:
 treating the substance so that it is no longer a hazardous
substance. Treatment does not include depositing the substance in
a landfill or sewage facility but can include controlled burning
providing that the performance requirements as set out in
regulation 6(3)(b) of the Disposal Regulations for protecting
people and the environment are met, or

exporting the substance from New Zealand as a hazardous waste.
However, there is provision for flammable gases (class 2.1.1), aerosols
(class 2.1.2) liquids (class 3.1) and readily combustible solids (class 4.1.1)
to be discharged into the environment as waste or deposited 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
D6
Regulation 10

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
Disposal requirements for packages
This control gives the disposal requirements for packages that contained
VBPOC 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.
D7
Regulations
11, 12
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 amount of VBPOC
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, ie 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 Regs 34-36 of the Identification
regulations (code I1).
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D8
Regulation2
Explanation3
Regulations
13, 14
Documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in a MSDS) that must be provided when selling or supplying
any amount of VBPOC.
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 Regs 48
(2), (3) and (4) of the Identification regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM1,
EM4,
EM6,
EM7
Regulations 6,
7, 8(c), 8(e),
8(f), 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 any
hazardous substance when present in quantities exceeding the trigger levels
as listed in Schedule 1 of the Emergency Management Regulations. Where
a substance triggers more than one hazard classification, the most stringent
quantity generally applies.
Schedule 1 does not cover VBPOC due to a printing error in the
regulations. Suppliers and persons in charge of places are recommended to
adopt this control for any amount of VBPOC.
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 VBPOC is being transported.
Additional Requirements for flammable substances
The following information must be provided with flammable substances
when present in quantities equal to or greater than the trigger levels as listed
in Schedule 1 of the Emergency Management Regulations.
 A description of the material and equipment needed to put out a
fire involving it

For those substances subject to temperature control under the
Hazardous Substances (Classes 1 to 5 Controls) Regulations (ie
any class 3.2, 4.1.1, 4.1.2, 4.1.3, 4.2 or 4.3 substance), a warning
of the temperature at which it is likely to ignite.
For VBPOC, the trigger level is 1 L.
Information requirements for toxic substances
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Regulation2
Explanation3
The following information must be provided when a toxic substance of
class 6.1, 6.3, 6.4 or 6.5 is present in quantities exceeding the trigger levels
as listed in Schedule 1 of the Emergency Management Regulations.
 A description of the usual symptoms of exposure

A description of the first aid to be given

A 24-hour emergency service telephone number
Schedule 1 does not cover VBPOC due to a printing error in the
regulations. Suppliers and persons in charge of places are recommended to
adopt this control for any amount of VBPOC.
Information requirements for ecotoxic substances
The following information must be provided with ecotoxic substances when
present in quantities exceeding the trigger levels as listed in Schedule 1 of
the Emergency Management Regulations.
 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
the substance from entering or affecting those parts of the
environment
Schedule 1 does not cover VBPOC due to a printing error in the
regulations. Suppliers and persons in charge of places are recommended to
adopt this control for 0.1 L of VBPOC.
EM8
Regulations
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 Material Safety Data Sheets). This
documentation must be provided where any amount of VBPOC is sold or
supplied, or held in a workplace.
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 VBPOC is being transported, and regulation 16
specifies requirements for general contents of the documentation.
Regulation 18 provides accessibility requirements (documentation to be
available within 5 minutes) and regulation 19 provides requirements for
presentation with respect to comprehensibility and clarity. These
requirements correspond with those relating to documentation required by
the identification regulations (code I21).
EM9
Regulation 17
Extra content for VBPOC
There is an additional requirement for VBPOC that a description be
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EM10
Regulation2
Explanation3
provided of the steps to be taken to control any fire involving the substance,
including the types of extinguishant to be used.
Regulations
21 – 24
Fire extinguishers
In every place (including vehicles) where VBPOC is held in quantities
exceeding 250 L, two fire extinguishers must be provided in accordance
with these regulations. 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 hazardous
substances.
Each fire extinguisher must be located within 30 m of the substance, or, in a
transportation situation, in or on the vehicle [Reg 22]. The performance
measure for an extinguisher is that it must be capable of extinguishing a
fully ignited pool of flammable liquid (50 mm deep and at least 6 m2 in
area), before the extinguisher is exhausted, and when used by one person
[Reg 23].
EM11
Regulations
25-34
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 greater than
or equal to 100 L of VBPOC is held.
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 – 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.
EM12
Regulations
35-41
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 greater than or equal to
100L of VBPOC are held.
Regulation 37 prescribes requirements for places where VBPOC is held
above ground in containers each holding up to 60 L or less. Regulation 38
prescribes requirements for places where VBPOC is held above ground in
containers each holding between 60 L and 450 L. Regulation 39 prescribes
requirements for places where VBPOC is held above ground in containers
each holding more than 450 L. Regulation 40 prescribes requirements for
places where VBPOC is held underground. Regulation 41 prescribes
requirements for secondary containment systems that contain substances of
specific hazard classifications, eg there is a requirement to prevent
substances from coming into contact with incompatible materials, and a
requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances
are contained).
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Regulation2
Explanation3
EM13
Regulation 42
Level 3 emergency management requirements – signage
These controls relates to the provision of emergency management
information on signage at places where greater than or equal to 100L of
VBPOC are held.
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
Regulations
4-6
Approved Handler requirements (including test certificate and
qualification requirements)
Some (highly) hazardous substances are 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.
It is considered that the adverse effects identified as a pour-on insecticide
for the end user of VBPOC are less than would usually be associated with
substances given this hazard classification and therefore this control does
not apply to the end user where quantities of 20 L or less of VBPOC is held.
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