ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Decision signed 2 September 2005
Decision amended under S67A to make controls consistent to those applied to similar
substances during Transfer.
Original decision signed on 1 September 2003
Application Code
HSR03010
Application Type
To import or manufacture any hazardous substance
under Section 29 of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Applicant
Monsanto Australia Limited
Date Application Received
4 March 2003
Consideration Date
14 August 2003
Considered by
The Hazardous Substances Standing Committee of the
Authority
Purpose of the Application
To import and manufacture for release, Roundup
TransorbTM , for use as a herbicide for the control of
weeds in non-selective situations
1
Summary of Decision
1.1
The application to import or manufacture Roundup TransorbTM 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.
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
Roundup TransorbTM
1.3
Roundup TransorbTM is a herbicide containing 52 % w/v of glyphosate potassium salt as
the active ingredient for the control of a range of annual and perennial broadleaf and
grass weeds.
1.4
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:
4
Wide dispersive use
Industrial category:
1
Agricultural industry
Function/Use category:
38
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 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 4 March 2003 and verified on 17 March 2003.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(b) and 7, public notification
was made on 17 March 2003.
3.3
Submissions closed on 1 May 2003. No submissions were received (section 54, clause
5).
3.4
The applicant requested that the time-line for the processing of the application be
waived (section 59(3)(a)(i)) three times (15 May, 27 June and 16 July).
3.5
Various government departments (including the Ministry of Health, the Department of
Labour (Occupational Safety and Health) and the New Zealand Food Safety Authority
(Agricultural Compounds and Veterinary Medicines Group), 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.
3.6
Responses were received from:
The Ministry of Health commenting that this substance may be available for
domestic use and the applicant had failed to mention how members of the public,
particularly children could be exposed to it and how this could be mitigated.
The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group) noting that this substance will also be considered under the
ACVM Act.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 2 of 22
Fish and Game New Zealand, Eastern Region, noting that they do not consider the
substances will pose a risk to sports fish or game birds or their habitats when used
appropriately.
The Human Rights Commission advising that they would not be providing comment
or making a submission.
The Taranaki Regional Council commenting that labelling instructions on the
containers should include instructions for the use of the substance near waterways,
limits set by ERMA on such usage and instructions addressing the burning of empty
retail containers.
3.7
The Committee took these responses into account in their consideration of this
application.
3.8
No external experts were used in the consideration of this application (clause 17).
3.9
A public hearing was not required to be held.
4
Consideration
Purpose of the Application
4.1
The purpose of the application is to import and manufacture for release, Roundup
TransorbTM , for use as a herbicide for the control of weeds in non-selective situations
Sequence of the Consideration
4.2
Members of the Hazardous Substances Standing Committee: Mr Tony Haggerty and Dr
Max Suckling considered the application (section 19(2)(b)).
4.3
The information available to the Committee comprised:
The application including confidential formulation information and confidential
references.
Letter noting change of name dated 10 April 2003 including copy of proposed label.
The original name of the substance was Roundup Powermax.
Additional information being the applicant’s response to the European
Commission’s 2002 review of glyphosate, letter dated 4 June 2003.
Additional information relating to ecotoxicity, letter dated 21 July 2003.
The Evaluation and Review (E & R) Report.
4.4
The evidence provided by the applicant and additional evidence set out in the E & R
Report were both scientific and related to values and other matters relevant to Part II of
the Act and were considered in terms of clause 25.
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.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 3 of 22
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.
4.6
In assessing risk, the Committee gave particular consideration to risks arising from the
significant hazards of the substance and examined the extent to which exposure to a
hazard would be mitigated by controls (clauses 11 and 12).
Hazard Classification
4.7
The Committee agreed with ERMA New Zealand’s hazard classification of the
substance as follows:
6.1D (acute toxicant – inhalation)
6.3B (skin irritant)
9.1A (aquatic ecotoxicant)
Default Controls
4.8
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
(in Section 8) and are not reproduced here.
Assessment of the potentially non-negligible risks
4.9
In identifying 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, the
Committee took into account all effects of the substance during its life cycle in
accordance with section 29(1)(a)(ii).
4.10
The Committee reviewed the identification of risks made by the applicant and additional
risks identified in the E&R Report.
4.11
Following this review, the Committee considered that the use of Roundup TransorbTM
gives rise to potentially non-negligible risks to the environment from the transport of
large quantities, from mixing prior to use, from spray drift and during application to
water bodies for the control of aquatic weeds.
4.12
The substance is to be imported into New Zealand in plastic lined bulk containers of
20,000 litres capacity and in 400 and 1000 litre containers. These bulk containers would
be required to comply with the International Maritime Dangerous Goods Code and the
Land Transport Rule: Dangerous Goods 1999 and as such would be expected to contain
the substance in the event of an accident. With controls in place it is
very unlikely that
the transport or storage of bulk quantities of Roundup TransorbTM would lead to an
adverse effect on the aquatic environment. If the substance did spill from a bulk
container such that it entered the aquatic environment the effect would be
moderate in
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 4 of 22
magnitude given that measurable damage would be done. Though measurable the
damage would be expected to be short term and reversible. Consequently the level of
risk is assessed as
low.
4.13
There is the potential for spillage when diluting and mixing the substance prior to
spraying. Even with controls in place there is an
equal chance that this will result in an
adverse effect on the aquatic environment or on terrestrial plants and if it did the
magnitude would be
minimal. This results in a
low level of risk.
4.14
Using good agricultural practice it is
unlikely that spray drift would cause adverse
effects on non-target terrestrial plants and emergent aquatic plants and if it did the effect
would be
minor, i.e. the level of risk is
low.
4.15
For aquatic uses spray would directly enter the aquatic environment as the intent is that
the substance is toxic to the target aquatic plants or plants overhanging the water body.
Non-target aquatic organisms would be at risk of being adversely affected as well,
meaning it is
likely that an adverse effect will occur though the magnitude would be
expected to be
minor. The result is a
medium level of risk to non-target organisms.
4.16
The Committee considers that overall the intended use of Roundup TransorbTM is likely
to give rise to a
low to
medium level of risk. Under section 29 and clause 27 these non-
negligible risks and their associated costs are to be weighed against the benefits
associated with the release of Roundup TransorbTM in New Zealand.
Assessment of the potentially non-negligible costs
4.17
A “cost” is defined in clause 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).
4.18
In relation to the costs of effects identified in the above table, the Committee considered
that although there are risks to the environment, no significant economic costs (new or
cumulative) will result from the release of Roundup TransorbTM.
Benefits
4.19
A “benefit” is defined in clause 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.
4.20
For this substance, the Committee considered that benefits are:
In common with other glyphosate formulations, its use as an effective herbicide with
relatively low toxicity to humans.
A more concentrated formulation than most other glyphosate formulations leading
to economies in transport and packaging.
A formulation that is rainfast, that is, it can be applied within a shorter period before
rain than many other formulations.
Increased consumer choice.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 5 of 22
4.21
It is not expected that Roundup TransorbTM will lead to an increase in the use of
glyphosate based herbicides but that it will replace other formulations in the market.
This means that existing benefits of this type of substance remain along with the
additional benefits of the higher concentration and the rainfast claim.
4.22
The Committee is unable to place an expected value on the benefits (clause 13(b)) but is
satisfied that the ability of the applicant and others to use Roundup TransorbTM should
give rise to the associated benefits.
4.23
With respect to section 29(a)(iii) and (b)(iii), some of the likely effects of the substance
being unavailable can be outlined as the inability to achieve the benefits outlined above.
Variation of Controls under Section 77
4.24
Under section 77(3), (4) and (5), the default controls determined by the hazardous
properties of the substance may be varied to achieve the most cost-effective
management of risks for the applicant and the community (clause 35(a)).
4.25
The applicant was given the opportunity to comment on the proposed controls as set out
in the E & R Report (clause 35(b)). A verbal comment was received relating to the
keeping of records of use and the need for an approved handler; the view expressed was
that neither of these controls were appropriate. This comment was taken into account in
the consideration of controls.
4.26
The Committee considered that the following variations should apply.
4.27
Control E11 requires the setting of an EEL. An EELwater is set for glyphosate. However,
the classification of Roundup TransorbTM indicated that it is not necessary to set an
EELsoil or EELsediment and the default values for these are deleted under section 77(4)(a).
4.28
The EELwater for glyphosate is set at 0.37 mg/L which differs from that set in a previous
approval for a glyphosate based herbicide (Touchdown IQ, application number
HSR02037, EELwater = 3.6 mg/L). The reason for this relates to a new interpretation of
international guidelines. Only one EELwater can apply to a substance or a component.
Therefore, the previously set EELwater is to be rescinded.
4.29
Control E8 specifying restrictions on the carriage of Roundup TransorbTM on passenger
service vehicles are combined with T7 (section 77(5)) so that E8 alone takes effect as
the most stringent of the controls.
4.30
The Committee considered that a number of controls that include requirements arising
from the 6.1D (acute inhalation toxicant) classification should be modified. The reason
for this is that the adverse effects on human health are unlikely to be realised. On this
basis the following controls are varied under section 77(4)(a).
Controls I8, I17, I18, I20 and I30 are deleted.
Controls I16 and I28 are varied to the extent that they do not apply to the 6.1D
classification but still apply to the 6.3B classification.
1 Control codes are those assigned by ERMA NZ to enable easy cross reference with the regulations. A detailed list
of these codes is contained in the ERMA New Zealand User Guide to the Controls Regulations.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 6 of 22
Control I21 is varied so the trigger level for the 9.1A classification applies.
Control D8 is varied so the trigger level for the 9.1A classification applies.
Control EM8 is varied so the trigger level for the 9.1A classification applies.
4.31
Controls E7 and AH1 relate to the requirement that the substance be under the control
of an approved handler. In general if this control was applied to all stages of the
lifecycle of this substance it would impose a cost that would make it difficult for the
benefits to be realised, for instance it would effectively prevent it being used in the
home and garden market. However, the risk of adverse effects within the aquatic
environment are such that use near or in or on water bodies should be subject to the
control that application in these areas is restricted to an approved handler. Accordingly,
control E7 is amended (section 77(4)(b)) to apply to any application of the substance
directly onto or into water, where water is defined under “environmental medium” in
the Hazardous Substances (Class 6, 8 and 9 Controls) Regulations 2001 and would
include, but not be limited to, ponds, lakes, rivers, streams, drains, marine foreshores,
etc.
4.32
Control TR1 relates to the requirement to track a substance throughout the whole of its
lifecycle. The Committee considers that this control would impose a burden on the users
of this substance that would make it difficult for the benefits to be realised, but the
control would not reduce the likelihood of adverse effects. It is noted that control E5
does require records to be kept if more than 3 kgs is used within 24 hours directly onto
or into water. Consequently, control TR1 is deleted under section 77(4)(b).
4.33
Controls EM6 and EM7 refer to regulations on emergency management applying to
toxic and ecotoxic substances and make reference to Schedule 1 of the Emergency
Management Regulations. However, there is no reference to these substances in
Schedule 1 due to a printing error. It is recommended that these controls apply to
Roundup TransorbTM with a trigger level of 1 litre for toxicity information (6.3B) and
0.2 litres for ecotoxicity information.
4.34
Controls EM11, EM12 and EM13 are amended (September 2005) to apply with a
trigger quantity of 1000 litres.
4.35
The controls, with the above adjustments are listed in Appendix 1. Controls that are not
applicable to Roundup TransorbTM are not listed.
Establishment of the Approach to Risk in the Light of Risk Characteristics
4.36
Clause 33 requires the Authority, when considering applications, to have regard for the
extent to which a specified set of risk characteristics exist. 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.
4.37
It was noted that the application of Roundup TransorbTM will be deliberate and the
significant risks resulting from adverse effects on non-target species are involuntary.
However, the effects are confined to the locality of any incident, will not persist over
time and are reversible. Furthermore, the risks are well understood and can be managed.
4.38
In light of these risk characteristics, the Committee is satisfied that it can be less risk
averse in weighing up risks and costs against benefits.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 7 of 22
Overall Evaluation of Risks, Costs and Benefits
4.39
Having regard to clauses 22 and 34 and in accordance with the tests in clause 27 and
section 29, risks costs and benefits were evaluated taking account of all proposed
controls including default controls.
4.40
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.
4.41
The Committee considered that, with the various controls in place, Roundup TransorbTM
poses non-negligible risks to the environment outside the application area. However, the
Committee is satisfied that the benefits of the substance outweigh the risks and costs
and that the application may therefore be approved in accordance with clause 27.
Environmental User Charges
4.42
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.
5
Decision
5.1
Pursuant to section 29 of the Act, the Committee has considered this application to
import and manufacture 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 27 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 benefits associated with
the substance outweigh the risks and costs.
5.3
The Committee is satisfied that the default controls, together with the variations
imposed, will be adequate to manage the adverse effects of the hazardous substance.
5.4
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 27 of the Methodology.
5.5
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 14 – costs and benefits accruing to New Zealand;
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;
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 8 of 22
clause 27 – risks 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.
5.6
The application for importation and manufacture of the hazardous substance
Roundup
TransorbTM is thus
approved with controls as detailed in Appendix 1.
Tony Haggerty
Date 1 September 2003
Chair Hazardous Substances Committee
Approval Code:
HSR000074
Amendments, September 2005
Amendments have been made to:
1. Control E7 and paragraph 4.31, amending the wording to state that the approved handler
control will apply to any application of the substance directly onto or into water.
2. Control E5 and paragraph 4.32, amending the wording to state that keeping records of use
will apply to any application of the substance directly onto or into water.
3. Controls EM11, EM12, EM13 and paragraph 4.34, amending the trigger level to 1000
litres.
Tony Haggerty
Date 2 September 2005
Chair Hazardous Substances Committee
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 9 of 22
Appendix 1: List of Controls that apply to Roundup
TransorbTM.
Control
Code2
Regulation3
Explanation4
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls
E1
Regulations
Limiting exposure to ecotoxic substances
32-45
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 EEL for glyphosate is set at 0.37 mg/L.
E2
Regulations
Restrictions on use within application area
46-48
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.
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).
The maximum application rate for Roundup TransorbTM is set at 13.2
litres per hectare.
E5
Regulations
Requirements for keeping records of use
5(2), 6
A person using a substance that is highly ecotoxic (ie. has a hazard
classification of 9.1A, 9.2A, 9.3A, or 9.4A) must keep a written record of
that use if 3kg or more of the substance is applied or discharged within 24
2 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.
3 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.
4 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 10 of 22
Control
Code2
Regulation3
Explanation4
hours in an area where the substance may enter air or water (and leave the
place where it is under control).
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.
This control applies to any application of the substance directly onto or
into water where water is defined under “environmental medium” in the
Hazardous Substances (Class 6, 8 and 9 Controls) Regulations 2001 and
would include, but not be limited to, ponds, lakes, rivers, streams,
drains, marine foreshores, etc.
E6
Regulation 7
Requirements for equipment used to handle hazardous substances
Any equipment used to handle ecotoxic substances (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 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.
This control applies to any application of the substance directly onto or
into water, where water is defined under “environmental medium” in
the Hazardous Substances (Class 6, 8 and 9 Controls) Regulations 2001
and would include, but not be limited to, ponds, lakes, rivers, streams,
drains, marine foreshores, etc.
E8
Regulation 10
Restrictions on the carriage of hazardous substances on passenger
service vehicles
In order to limit the potential for environmental exposure to ecotoxic
substances, the carriage of any class 9 substance on passenger service
vehicles is restricted to 5L.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of hazardous substances in terms of:
information that must be “immediately available” with the substance
(priority and secondary identifiers). This information is generally
provided by way of the product label
documentation that must be available in the workplace, generally
provided by way of MSDS
signage at a place where there is a large quantity of the substance.
I1
Regulations 6,
General identification requirements
7, 32-35, 36
These controls relate to the duties of suppliers and persons in charge of
(1)-(7)
hazardous substances with respect to identification (essentially labelling)
(Regulations 6 and 7), accessibility of the required information (Regulations
32 and 33) and presentation of the required information with respect to
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 11 of 22
Control
Code2
Regulation3
Explanation4
comprehensibility, clarity and durability (Regulations 34, 35, 36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of any hazardous substance 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 the substance
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 the substance
(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 any hazardous substance 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 the
substance within
two seconds (Regulation 32), and the secondary identifier
information available within
10 seconds (Regulation 33).
Persons in charge must also ensure that no information is supplied with the
substance (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
All priority identifier Information (as required by Regulations 8 to 17) must
be available within
2 seconds, eg. on the label
All secondary identifier Information (as required by Regulations 18 to 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
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.
I3
Regulation 9
Priority identifiers for ecotoxic substances
This requirement specifies that ecotoxic substances must be prominently
identified as being ecotoxic.
This information must be available to any person handling the substance
within
two seconds (Regulation 32) and can be provided by way of signal
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 12 of 22
Control
Code2
Regulation3
Explanation4
headings or commonly understood pictograms on the label.
I9
Regulation 18
Secondary identifiers for all hazardous substances
This control relates to detail required for hazardous substances on the product
label. This information must be accessible within
10 seconds (Regulation 33)
and could be provided on secondary panels on the product label. The
following information is required:
an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it, and
enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone, and
in the case of 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.
I11
Regulation 20
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for ecotoxic
substances. 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
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)
I16
Regulation 25
Secondary identifiers for toxic substances
This control relates to the additional label detail required for toxic
substances. 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 (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
This applies to the 6.3B classification only.
I19
Regulations
Alternative information in certain cases
29-31
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
substances are contained in fixed bulk containers or bulk transport
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 13 of 22
Control
Code2
Regulation3
Explanation4
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.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when hazardous substances are 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 hazardous
substances that are 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.
I21
Regulations
Documentation required in places of work
37-39, 47-50
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) (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 substances of specific hazard
classifications are held in the workplace in quantities equal to or greater than
the levels as specified in Schedule 2 of the Identification Regulations. 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 to 46 when selling or supplying to another person
a quantity of a hazardous substance equal to or greater than the levels
specified in Schedule 2 for that classification, if the substance is to be used in
a place of work and the supplier has not previously provided the
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 14 of 22
Control
Code2
Regulation3
Explanation4
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 hazardous substances are
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 the substance has access to the
documentation containing all relevant information required by Regulations
39 to 46. The person in charge must also ensure that the documentation does
not contain any information that suggests that the substance belongs to a
hazard classification it does not in fact belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with a hazardous substance 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/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 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.
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (eg. as provided on an MSDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance 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 that
substance.
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
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 15 of 22
Control
Code2
Regulation3
Explanation4
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 a hazardous
substance is present) if asked to do so by that person.
The trigger level for Roundup TransorbTM is 5 litres.
I23
Regulation 41
Specific documentation requirements for ecotoxic substances
The documentation provided with ecotoxic substances 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
any EELs set by the Authority.
I28
Regulation 46
Specific documentation requirements for toxic substances
The documentation provided with toxic substances must include the
following information:
its general degree and type of toxic hazard
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
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
any TELs or WESs set by the Authority.
This applies to the 6.3B classification only.
I29
Regulations
Duties of persons in charge of places with respect to signage
51-52
These controls specify the requirements for signage, in terms of content,
presentation and positioning at places where hazardous substances are held in
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 16 of 22
Control
Code2
Regulation3
Explanation4
quantities exceeding the amounts specified in Schedule 3 of the Identification
Regulations. Where a substance triggers more than one hazard classification,
the most stringent quantity generally applies.
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
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).
The trigger level for Roundup TransorbTM is 100 litres.
Hazardous Substances (Packaging) Regulations 2001
P1
Regulations 5,
General packaging requirements
6, 7 (1), 8
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 all hazardous substances 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 are removed from the package and the packaging is then
re-closed. The packaging in direct contact with the substance 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 hazardous substances must not be marked in accordance
with the UN Model Regulations unless:
the markings comply with the relevant provisions of that document, and
the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively, and
the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
When packing any hazardous substance, 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.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 17 of 22
Control
Code2
Regulation3
Explanation4
Regulation 8 – Compatibility
Hazardous substances must not be packed in packaging that has been
previously packed with substances with which it is incompatible.
P3
Regulation 9
Packaging requirements for substances packed in limited quantities
When substances of certain hazard classifications are packaged in limited
quantities, there is provision for them to be packaged to a lesser performance
standard (as specified in Schedule 4 of the Packaging Regulations) than
normally required. A list of those hazard classifications, and the maximum
quantity of substance that may be packaged to this lesser performance
standard, is provided in Schedule 5.
P13
Regulation 19
Packaging requirements for toxic substances
The packaging requirements for class 6 substances are as follows:
6.3A, 6.3B, 6.4A and 6.1D substances in quantities less than 450L or
400kg must be packaged according to Schedule 4.
There is a provision that packages containing less than 0.5L (500mL) of a
class 6.1D, 6.3A, 6.3B, 6.4A substance do not have to comply with the drop
test performance standard contained in Schedule 4 provided the packaging
complies with the requirements of Regulations 5(1)(a), (b) and (e), and there
is a warning statement on the outside of the package that the package may
not withstand a drop of 0.5m (Regulation 9(3)-(5)).
Any substance of hazard classification 6.1D, 6.1E, 6.3A, 6.3B or 6.4A that is
offered for sale in a package of less than 2.5L or 2.5kg must be in child
resistant packaging (ie. toxic substances liable to be in homes). However, if
the substance is for use in a place of work to which children do not have
access, this requirement is not mandatory.
P15
Regulation 21
Packaging requirements for ecotoxic substances
The packaging requirements for class 9 substances are as follows:
9.1A–C, 9.2A–C, 9.3A–C and 9.4A–C substances in quantities of more
than 5kg or 5L must be packaged according to Schedule 3 (UN PGIII),
but may be packaged according to Schedule 4 when in quantities equal to
or less than 5kg or 5L. However, there is a provision that packages
containing less than 0.5L (500mL) of a class 9.1C or 9.2C substance do
not have to comply with the drop test performance standard contained in
Schedule 4 provided the packaging complies with the requirements of
Regulations 5(1)(a), (b) and (e), and there is a warning statement on the
outside of the package that the package may not withstand a drop of
0.5m.
PG3
Schedule 3
This schedule provides the test methods for packaging required to be tested
in accordance with this schedule. The tests in Schedule 3 correlate to the
packaging requirements of UN Packing Group III (UN PGIII).
Hazardous Substances (Disposal) Regulations 2001
D4
Regulation 8
Disposal requirements for toxic substances
A class 6 substance must be disposed of by:
treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with
any other substance prior to discharge to the environment; or
discharging the substance to the environment provided that after
reasonable mixing, the concentration of the substance in any part of the
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 18 of 22
Control
Code2
Regulation3
Explanation4
environment outside the mixing zone does not exceed any TEL (tolerable
exposure limit) set by the Authority for that substance; or
exporting the substance from New Zealand as a hazardous waste.
D5
Regulation 9
Disposal requirements for ecotoxic substances
A class 9 substance must be disposed of by:
treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with
any other substance prior to discharge to the environment; or
discharging the substance to the environment provided that after
reasonable mixing, the concentration of the substance in any part of the
environment outside the mixing zone does not exceed any EEL
(environmental exposure limit) set by the Authority for that substance; or
exporting the substance from New Zealand as a hazardous waste
D6
Regulation 10
Disposal requirements for packages
This control gives the disposal requirements for packages that contained a
hazardous substance and are no longer to be used for that purpose. Such
packages must be either decontaminated/treated or rendered incapable of
containing any substance (hazardous or otherwise) and then disposed of in a
manner that is consistent with the disposal requirements for the substance. In
addition, the manner of disposal must take into account the material that the
package is manufactured from.
D7
Regulations 11,
Disposal information requirements
12
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 a hazardous substance that exceeds the trigger levels as specified
in Schedule 1 of the Disposal Regulations. Where a substance triggers more
than one hazard classification, the most stringent quantity generally applies.
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 Regulations 34-36 of the Identification
Regulations (code I1).
The trigger level for Roundup TransorbTM is 0.1 litre.
D8
Regulations 13,
Disposal documentation requirements
14
These controls relate to the provision of documentation concerning disposal
(essentially in a MSDS) that must be provided when selling or supplying a
quantity of a hazardous substance that exceeds the trigger levels as specified
in Schedule 2 of the Disposal Regulations. Where a substance triggers more
than one hazard classification, the most stringent quantity generally applies.
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
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 19 of 22
Control
Code2
Regulation3
Explanation4
Regulations 48(2), (3) and (4) of the Identification Regulations (code I21).
The trigger level for Roundup TransorbTM is 5 litres.
Hazardous Substances (Emergency Management) Regulations 2001
EM1
Regulations 6,
Level 1 emergency management information: General requirements
7, 9-11
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 equal to or greater than 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.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the requirement
for the availability of the information (
10 seconds) and Regulation 10 gives
the requirements relating to the presentation of the information with respect
to comprehensibility, clarity and durability. These requirements correspond
with those relating to secondary identifiers required by the Identification
Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)).
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being transported.
EM6
Regulation 8(e)
Information requirements for toxic substances
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 equal to or greater than 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.
The recommended trigger level for Roundup TransorbTM is 1 litre.
EM7
Regulation 8(f)
Information requirements for ecotoxic substances
The following information must be provided with ecotoxic 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 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.
The recommended trigger level for Roundup TransorbTM is 0.1 litre.
EM8
Regulations
Level 2 emergency management information requirements
12-16, 18-20
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 hazardous substances are sold or
supplied, or held in a workplace, in quantities equal to or greater than the
quantities specified in Schedule 2 of the Emergency Management
Regulations. Where a substance triggers more than one hazard classification,
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 20 of 22
Control
Code2
Regulation3
Explanation4
the most stringent quantity generally applies.
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 the substance is being transported, and Regulation 16
specifies requirements for general contents of the documentation.
Regulation 18 provides accessibility requirements (documentation to be
available within
five 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).
The trigger level for Roundup TransorbTM is 5 litres.
EM11
Regulations
Level 3 emergency management requirements – emergency response
25-34
plans
These Regulations relate to the requirement for an emergency response plan
to be available at any place (excluding aircraft or ships) where hazardous
substances are held (or reasonably likely to be held on occasion) in quantities
greater than those specified in Schedule 4 of the Emergency Management
Regulations. Where a substance triggers more than one hazard classification,
the most stringent quantity generally applies.
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 is provided in Regulation 32 and requirements for testing the plan are
described in Regulation 33.
The trigger level for Roundup TransorbTM is 1000 litres.
EM12
Regulations
Level 3 emergency management requirements – secondary containment
35-41
These Regulations relate to the requirement for a secondary containment
system to be installed at any fixed location where liquid (or liquefiable)
hazardous substances are held in quantities equal to or greater than those
specified in Schedule 4 of the Emergency Management Regulations. Where
a substance triggers more than one hazard classification, the most stringent
quantity generally applies.
Regulation 37 prescribes requirements for places where hazardous
substances are held above ground in containers each holding up to 60L or
less. Regulation 38 prescribes requirements for places where hazardous
substances are held above ground in containers each holding between 60L
and 450L. Regulation 39 prescribes requirements for places where
hazardous substances are held above ground in containers each holding more
than 450L. Regulation 40 prescribes requirements for places where
hazardous substances are held underground. Regulation 41 prescribes
requirements for secondary containment systems that contain substances of
specific hazard classifications, eg. there is a requirement to prevent
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 21 of 22
Control
Code2
Regulation3
Explanation4
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).
The trigger level for Roundup TransorbTM is 1000 litres.
EM13
Regulation 42
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management information
on signage at places where hazardous substances are held at quantities equal
to or greater than the quantities specified in Schedule 5 of the Emergency
Management Regulations. Where a substance triggers more than one hazard
classification, the most stringent quantity generally applies.
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.
The trigger level for Roundup TransorbTM is 1000 litres.
Hazardous Substances (Personnel Qualification) Regulations 2001
AH1
Regulations 4-
Approved Handler requirements (including test certificate and
6
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.
ERMA New Zealand Evaluation and Review Report: Application HSR03010
Page 22 of 22
