Consideration Paper for the Issuing of the Organic Peroxides, Toxic [6.1], Corrosive
Group Standard 2009
Introduction
1
This Consideration Paper:
(a)
(b)
(c)
(d)
identifies the proposed group standard to be considered by the Decision Making
Committee;
discusses the matters that the Authority needs to be satisfied with, or to have
considered, under Part 6A of the Act to issue this group standard;
confirms that the Agency’s internal quality assurance process has been undertaken;
seeks approval to issue the group standard and publish notice of the issue in the New
Zealand Gazette.
Proposed group standard
2
The proposed group standard:
 Organic Peroxides, Toxic [6.1], Corrosive Group Standard 2009
Requirements of Part 6A of the Act
Public notification
3
Before issuing a group standard, section 96C(h) of the Act requires the Authority to
publicly notify–
(a)
(b)
the proposal to issue or amend (as the case may be) group standards; and
its assessment of the matters required under subsections (1)(a), (b), (c), (d) and (e) in
relation to the group standards as proposed to be issued or amended1
4
A public notice was placed in the main metropolitan newspapers (New Zealand Herald,
Dominion Post, Christchurch Press and the Otago Daily Times on Wednesday 26th
November 2008 indicating the release for consultation of the issuing of the group standard
for Organic Peroxides, Toxic [6.1], Corrosive. This notice stated where copies of the
proposal and other information could be obtained.
5
Release of the proposal was also notified on the ERMA New Zealand web site on 19
November 2008. The consultation document was available from the consultation page of
the web site from that date.
6
As required under the Act, thirty working days were allowed from the release of the
proposed group standards on the web site for the receipt of submissions. The submission
period ran from 19 November 2008 to 27 January 2009.
7
The consultation document included a submission form and explained the process for
making a submission. No submissions were received on this proposal.
1
These are the matters that relate to efficiency and effectiveness, nature, type or circumstance of use,
international practices and standards, and controls under sections 77, 77A and 77B. Note that s.96C(1)(d)
relates to the assessment required for manufactured articles, waste products, or manufacturing by-products
and is therefore not considered in this [Template].
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8
The consultation document also addressed matters that the Authority needs to be satisfied
with, or to have considered, for issuing group standards, specifically:
(a)
(b)
(c)
(d)
that the group standard will be a more efficient and effective way of managing the
risks of all the hazardous substances in the identified group;
that the proposed group standard is such that all the hazardous substances or products
in the identified group are of a similar nature, or a similar type, or have similar
circumstances of use, such that the risks the risks of the group can be effectively
managed by one set of conditions;
the best international practices and standards for the safe management of hazardous
substances;
the types of controls appropriate for the group in accordance with sections 77, 77A
and 77B of the Act.
Further consideration of each of these matters is given below.
More efficient and effective
9
Before issuing a group standard, sections 96C(1)(a), (b) and (c) of the Act require the
Authority to be satisfied that:
issuing…[the] group standard is a more efficient and effective way of managing the
risks of all the hazardous substances in the identified group.
Effectiveness
10
A group standard can be considered to be effective if it achieves the desired outcomes. In
the context of the purpose of the HSNO Act (protection of the environment, health and
safety of people and communities), effectiveness can be demonstrated against:
 policy objectives for the establishment of a group standard;
 technical feasibility to meet these policy objectives;
 achievement of risk management;
 level of compliance by users of the group standard.
Policy objective
11
The policy objective, in this case, is the capture of toxic, corrosive, organic peroxides
within the HSNO framework and the management of risks of the hazardous substances in
the group.
12
A group standard for toxic, corrosive, organic peroxides will achieve the approval under the
Act of these substances with a short timeframe, and therefore meet one of the measures of
effectiveness. In contrast, individual approvals of the large number of substances that may
be associated with the group standard, would require a considerably longer timeframe under
Part 5 of the Act and is, therefore, comparatively much less effective.
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13
The group standard allows similar types of substances to be given the same approval,
thereby facilitating the introduction of new products into the group standard. That is, any
new substance that fits within the scope of a group standard will have a HSNO approval
without the need for the manufacturer or importer to make a separate application to ERMA
New Zealand for approval under Part 5 of the Act.2
14
Finally, the risks of the substances are managed by setting conditions drawn from the suite
of HSNO Regulations.
Technical feasibility
15
A group standard for toxic, corrosive, organic peroxides is technically feasible because the
substances have been grouped on the basis of being of a similar nature. That is, the organic
peroxides have been grouped on the basis of their hazard characteristics (i.e. they are of a
similar nature). This approach allows one set of common conditions to be applied to the
group (i.e. to the group standard), which will manage the risks of substances in the group.
Risk management
16
The set of conditions used to manage the risks of the proposed group standard are primarily
drawn from the HSNO Regulations, and have been presented with a greater level of
guidance and in a simplified format. That is, information is expressed in a more direct,
user-friendly way than the regulations. Some conditions have retained the non-prescriptive
character of the current regulations, which allows for a variety of alternate means of
compliance. This will ensure a more predictable regulatory outcome.
Compliance
17
The proposed group standard should achieve an effective compliance rate because the
information on what is required to manage the substances in the group will be contained in
one, easy-to-access document with more user-friendly language and prescriptive elements.
This should lead to a greater level of understanding, thereby encouraging better
compliance, particularly by small to medium sized enterprises.
Conclusion
18
In summary, when assessed against alternate HSNO approval processes for hazardous
substances, the proposed group standard is considered to be a more effective way of
managing the risks of the group of substances. The compliance and risk management
framework that will be in place after the group standard has been issued will be consistent
with that for new approvals under Part 5 of the Act, and the conditions that will apply are
largely drawn from the suite of regulations that would apply to Part 5 approvals.
2
This will involve the manufacturer or importer undertaking their own hazard classification of the
substance in order to determine the appropriate group standard (see Section 4.2.2).
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Efficiency
19
A process can be described as efficient if it is working productively with minimum wasted
effort and expense. That is, a group standard is efficient if it is cost-effective. The costeffectiveness of one option can be assessed against another, in this case a group standard
approval versus multiple individual approvals by considering the relative costs that each
incur.
20
In general, the costs involved with approvals for new substances will raise the same issues
whether they are carried out via group standards or individually. Irrespective of which
method is employed, the costs will be related to resources, labour and time. An estimate of
the comparative costs to ERMA New Zealand of a group standard versus individual
approvals is provided in Box 1.3 This estimate is intended solely for illustrative purposes; it
considers only the regulatory costs to ERMA New Zealand and does not take account of
costs to notifiers or industry who will have their own approval-related costs. Nevertheless,
it is reasonable to assume that the comparative costs to notifiers and industry of the two
options will mirror those of ERMA New Zealand. That is, their costs for engaging in the
process to establish a group standard will be significantly lower than engaging in multiple
applications for individual approvals.
21
In addition to costs for the initial approval of a substance, there will be on-going
compliance costs for industry. However, because the conditions of the proposed group
standard are based substantially on the HSNO Regulations, there is no obvious reason why
the costs for compliance under the group standard approval would be any higher relative to
compliance costs for an individually approved substance. On the contrary, costs may be
lower because aspects of the group standard are written with a greater level of guidance and
in a user-friendly manner, thus making it easier to follow and comply with.
22
Arguably, there is the potential for increased adverse health and environmental effects
(which can be expressed as costs) if the group standard regime makes it easier for industry
to manufacture or import more hazardous substances. This is more likely to be a potential
problem if group standards are drafted widely. However, the proposed group standard is
not drafted in this way and is based around hazard profiles that currently exist.
23
There could be increased group standard specific costs, particularly for products imported
from overseas if the conditions of the group standard were not aligned with those of our
major trading partners. This has been minimised by following international best practices
and standards.
24
In summary, the proposed group standard is expected to be a more efficient option than
individual approvals for toxic, corrosive, organic peroxides. Individual approvals would
require each of the substances to be treated separately, so the process would need to be
repeated many times. Instead, the proposed group standard will enable ERMA New
Zealand to organise toxic, corrosive, organic peroxides into one group, then approve many
substances at once.
3
This should not be considered as a definitive assessment of the total costs of the two options.
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Box 1: Comparative costs of a group standard versus individual approvals
The following examples illustrate the cost-effectiveness of a group standard versus individual
approvals. These examples are based on the regulatory costs incurred by ERMA New Zealand for
ensuring substances have the necessary HSNO approval. They do not consider other costs to notifiers,
industry or other parties who engage in the HSNO approval process. Neither do they consider nonregulatory costs associated with the manufacture and marketing of a product in New Zealand. 4
New hazardous substance approval
The comparative costs for an approval of a new hazardous substance can be made using the current
ERMA New Zealand Fees and Charges Schedule. These fees are based on the actual costs to process
an application.5
1. The existing HSNO approvals for substances which are toxic, corrosive, organic peroxides relate to
pure chemicals only. Therefore anyone wishing to manufacture in or import into New Zealand a
mixture with this hazard profile would need to seek approval via Part 5 of the HSNO Act.
Under an individual approval (Part 5 full assessment), the ERMA New Zealand fee is $3,000, which
would be incurred by the manufacturer/importer, in addition to their own costs for preparing the
application.
Under a group standard approval, there would be no fee payable to ERMA New Zealand, and therefore
the direct cost to the manufacturer/importer for the approval would be $0.00.
2. Consider a manufacturer who reformulates an organic peroxide in the future by replacing one
stabiliser with another. It is assumed that the reformulated product:
(i) is covered by the proposed group standard approval; and
(ii) would not meet the ERMA New Zealand criteria for “same as” under the status of substance
policy, but would meet the criteria for a rapid assessment.
Under a group standard approval, there will be no fee to ERMA New Zealand, and therefore the direct
cost to the manufacturer for the approval would be $0.00.
Under an individual approval (Part 5 rapid assessment), the ERMA New Zealand fee is $500, which
would be incurred by the manufacturer, in addition to their own costs for preparing the application.
The cumulative difference will increase in rough proportion with the number of new products
approved. If a reformulated product were to require a Part 5 approval (not a “rapid similar” as per
example 2 above), the cost difference would be higher.
Overall, based on the above estimation of the costs, an approval under an existing group standard is
more cost-effective than a new individual approval.
One set of conditions for similar nature, type, or circumstance of use
25
Before issuing a group standard, section 96C(1)(e) requires that the Authority be satisfied
that:
if the group standard applies to 1 hazardous substance or product, the risks of that
hazardous substance or product can be effectively managed by 1 set of conditions; or
if the group standard applies to more than 1 hazardous substance or product, all the
hazardous substances or products have a similar nature, or are of a similar type, or
have similar circumstances of use, such that the risks of the group of hazardous
substances or products can be effectively managed by 1 set of conditions.
4
5
There is no reason why the manufacturing, marketing or other such costs would be different under a
group standard than an individual approval process.
Fees and Charges Schedule, Effective 1 July 2009: http://www.ermanz.govt.nz/about/fees.html
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26
The scope of the proposed group standard has been developed with existing substances as a
“representation” of the likely products that would fit into the group standard, both now and
in the future. A number of these existing products were previously incorrectly assigned to
one of the two existing group standards for organic peroxides, due to a lack of information
about the toxic nature of the substances. The proposed group standard has, therefore, taken
account of the existing products. To this end, toxic, corrosive, organic peroxides have been
grouped on the basis of their similar nature, in accord with the requirements of Part 6A of
the HSNO Act for establishing a group standard.
Similar Nature
27
Overall, products within a group standard that have the same primary hazard but a different
subsidiary hazard can be considered to be of a similar nature.
28
The proposed group standard has been established along hazard property criteria, consistent
with the management of new hazardous substances under Part 5 of the HSNO Act, the
transfer of existing substances under Part 160A of the Act, and the United Nations Model
Regulations for the Transportation of Dangerous Goods. Thus, the toxic, corrosive, organic
peroxides have been grouped on the basis of the hazard property (or combination of
properties) that requires the broadest set of conditions to manage the risk of the substances.6
The primary hazards for the proposed group standard are:
 oxidising potential;
 acute toxicity; and
 corrosivity.
29
Conditions applied to manage risk arising from the primary hazard of a product will also
generally manage any risk arising from a subsidiary hazard.7, 8 Thus, the proposed group
standard is able to include products with a diversity of subsidiary hazards where these can
generally be managed by the same set of conditions.
International practices and standards
30
Before issuing or amending a group standard, section 96C(1)(f) of the Act requires that the
Authority consider:
the best international practices and standards for the safe management of hazardous
substances and products
The requirement to consider best international practices and standards for the safe
management of hazardous substances is demonstrated by assessing the proposed group
standard against:
31
6
7
8
The primary hazard(s) of a group standard are common to all substances in the group. Note that the
term “primary hazard” is not actually used in a group standard.
Subsidiary hazards are those that require a lesser degree of risk management compared to the primary
hazard(s). For the proposed group standard, the subsidiary hazards may be all or any combination of the
following: classes 6.3, 6.4, 6.5, 6.6, 6.8, 6.9, 8.3 and all class 9. The subsidiary hazards may be
different between substances in the same group standard. Note that the term “subsidiary hazard” is not
actually used in a group standard.
An exception to this is in the requirement to provide label information on the properties of a product,
although even here information statements arising from a primary hazard may override statements
required for a subsidiary hazard. See Hazard and Precautionary Information for Group Standards,
October 2005, ERMA New Zealand (http://www.ermanz.govt.nz/consultations/gs/hp.pdf).
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 the Globally Harmonised System of Classification and Labelling of Chemicals;
 international codes of practice and standards; and
 overseas legislative requirements.
Globally Harmonised System
32
The conditions applied to the proposed group standard are based on the HSNO Regulations.
These regulations specify a number of controls aimed at managing the risk posed by
hazardous substances throughout their lifecycle, such as the requirement for protective
clothing and provision of appropriate information, disposal and emergency management
requirements. These regulations have previously met the requirements of Section 141(1)(b)
of the HSNO Act on best international practices and standards for the safe management of
hazardous substances. In particular, the Globally Harmonised System of Classification and
Labelling of Chemicals (GHS), published by the United Nations, forms the basis of the
HSNO hazard classification system and the requirements for the provision of information
on hazards.
33
Consideration has also been given to the Recommendations on the Transport of Dangerous
Goods Model Regulations, also published by the United Nations. For example, the
proposed group standard adopts directly the packaging provisions of the UN Model
Regulations, and similarly it provides for compliance with the labelling provisions via
compliance with the GHS.
International Codes of Practice and Standards
34
The transportation conditions of the proposed group standard requiring the segregation of
incompatible substances cross-references to the requirements of the Land Transport Rule,
the Maritime Rule and the Civil Aviation Rule, which are themselves based on the
international UN Transport of Dangerous Goods Model Regulations, the International
Maritime Dangerous Goods Code and the International Civil Aviation Organization
Regulations.
Overseas Legislative Requirements
35
Provision has been made in the proposed group standard for the importation into New
Zealand of substances that are labelled in accordance with the labelling requirements in
place in our major trading partners, such as Australia, United States and the European
Union, although this provision has a sunset clause currently set to expire on 31 December
2010, which is the time the GHS is envisaged to come into force internationally.
Controls under sections 77, 77A and 77B
36
Before issuing or amending a group standard, section 96C(1)(g) of the Act requires that the
Authority consider:
the types of controls appropriate for the group in accordance with sections 77, 77A
and 77B
37
Because the proposed group standard is centered on substances being of a similar nature,
one set of conditions can manage the risk of substances within the group.
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38
The conditions applied to the proposed group standard are based on the controls taken from
the HSNO regulatory ‘toolbox’. These controls, whilst hazard-based are designed to
minimise exposure to a substance and therefore minimise the potential for risk.
Consequently, the conditions of the proposed group standard will also manage any risk
from the substances within the group in the same way that the HSNO Regulations manage
risk for a new hazardous substance given a Part 5 approval.
39
In most cases, the trigger quantities applied to the proposed group standard conditions align
with those set out in the HSNO Regulations. This is important to ensure consistency with
existing HSNO approved substances approved under Part 5, and to facilitate compliance
and enforcement.
40
There are a number of new conditions from outside the HSNO ‘toolbox’ are included in the
proposed group standard. These are:
a.
a requirement for notification to the Authority if a product contains a chemical that is
not currently present in New Zealand;
b.
a condition that limits the introduction into New Zealand of any new chemical that is
a mutagen or reproductive toxicant without the need for further consideration and
approval by the Authority;
c.
a requirement for keeping a record of the basis for assigning any new organic
peroxides to this group standard, and keeping that record available for inspection; and
d.
a requirement to exclude any product that is a single component chemical and which
is not listed on the Inventory of Chemicals maintained by ERMA New Zealand.
Quality Assurance Process
41
As required by the Internal Quality Assurance System for the issuing of deemed
regulations, approved by the Authority in August 2006, the issue of this group standard was
formally ‘certified’ by Manager, Legal & Risk on 23 June 2009 stating compliance with the
following matters:
Authorised by HSNO Act
The proposed group standard is within the empowering provision of the HSNO Act
(namely, section 96B).
Treaty of Waitangi
The proposed group standard has no effect on the principles of the Treaty.
New Zealand Bill of Rights Act 1990 and Human Rights Act 1993
The proposed group standard has no effect on the rights and freedoms guaranteed by these
Acts.
Privacy Act 1993
The proposed group standard complies with the privacy principles in this Act.
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International Standards and Obligations
The proposed group standard has no adverse effect on New Zealand’s international
obligations
28 Day Rule
The 28 day rule will be complied with. The proposed group standard will come into force
28 days after publication in the New Zealand Gazette.
Quality of Drafting
The proposed group standard has been checked by Manager, Legal & Risk for clarity of
drafting.
Standing Order 378
The issuing of this group standard will not be drawn to the attention of the House by the
Regulations Review Committee pursuant to Standing Order 378.
42
The Regulations Review Committee will not find that the issuing of this group standard:
(a) is not in accordance with the general objects and intentions of the HSNO Act;
(b) trespasses unduly on personal rights and liberties;
(c) appears to make some unusual or unexpected use of the powers conferred by the
HSNO Act;
(d) unduly makes the rights and liberties of the person dependant on administrative
decisions which are not subject to review on their merits by a judicial or other
independent tribunal;
(e) excludes the jurisdiction of the courts without explicit authorisation in the Act;
(f) contains matters more appropriate for parliamentary enactment;
(g) is retrospective where this is not expressly authorised by the Act;
(h) was not made in compliance with particular notice and consultation procedures
prescribed by the Act;
(i)
for any other reason concerning its form or purport, calls for elucidation.
Notice of Issuing of a new Group Standard
43
A formal notice of the issuing of the Organic Peroxides, Toxic [6.1], Corrosive Group
Standard 2009 will be published in the New Zealand Gazette. The proposed group
standard is attached as Annex A.
44
Pursuant to section 96B(6) of the Act, as soon as practicable after issuing a group standard,
the Authority must:
(a)
(b)
(c)
45
publish the group standard in a publication relevant to the affected persons; and
make the group standard available to be inspected free of charge and purchased at a
reasonable price; and
give public notice of where the group standard can be inspected or purchased.
These requirements will be met by the group standard being available directly from ERMA
New Zealand and on the ERMA New Zealand website.
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Recommendations
46
It is recommended that the Committee:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
Note the proposal to issue the Organic Peroxides, Toxic [6.1], Corrosive Group
Standard 2009;
Note that public notification and consultation was undertaken in accordance with the
requirements of the Act;
Note that no submissions were received from the consultation;
Agree that the proposed group standard is such that all the hazardous substances or
products in the identified group are of a similar nature, or a similar type, or have
similar circumstances of use, such that the risks the risks of the group can be
effectively managed by one set of conditions;
Agree that the Organic Peroxides, Toxic [6.1], Corrosive Group Standard 2009 is a
more efficient and effective way of managing the risks of the substances in the group;
Agree that best international practices and standards have been considered in
developing group standards for organic peroxides;
Agree that the types of controls appropriate under sections 77, 77A and 77B of the
Act have been considered;
Note that the requirements of the internal quality assurance system have been met,
and been certified by Manager, Legal & Risk.
Agree to the issuing of the Organic Peroxides, Toxic [6.1], Corrosive Group Standard
2009 and to its publication in the New Zealand Gazette;
Note that the Organic Peroxides, Toxic [6.1], Corrosive Group Standard 2009 will
come into force 28 days after publication in the New Zealand Gazette;
Note the proposals for publishing the group standard in publication(s) relevant to
affected persons, where the group standard can be inspected free of charge, that it can
be purchased at a reasonable price and that there will be public notice of where it can
be inspected or purchased.
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Annex A:
Proposed Gazette Notice
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