ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
1 July 2003
Application Code
HSC03002
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Orica New Zealand Limited
Purpose of the Application
To manufacture and trial the 7C formulations as
cleaning additives in New Zealand and confirm that they
do the desired job.
Date Application Received
23 May 2003
Consideration Date
1 July 2003
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import or manufacture 7CN, 7CE and 7CNE is approved with
controls in accordance with the relevant provisions of the Hazardous Substances and
New Organisms Act 1996 (the HSNO Act) and the HSNO (Methodology) Order 1998.
1.2
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
7CN
7CE
7CNE
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31 of the HSNO Act. The decision was
determined in accordance with section 32, 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 and the provisions of Part III of the Third Schedule of
the HSNO Act. Unless otherwise stated, references to section numbers in this decision
refer to sections of the HSNO Act.
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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 purpose of the application is to manufacture and trial the 7C substances (7CE, 7CN
and 7CNE) as cleaning additives in New Zealand.
3.2
The application was formally received on 23 May 2003 and verified as having sufficient
information on 9 June 2003.
3.3
The applicant supplied the following documents that included information identified as
confidential:
 The application
 Formulation details (confidential appendix)
 Material Safety Data Sheets for each component (confidential appendix)
3.4
The following Government departments were advised of the receipt of the application
(in accordance with clause 2(2)(e)) and given the opportunity to comment.
 The Ministry of Health.
 The Department of Labour (Occupational Safety and Health).
3.5
No responses were received.
3.6
The ERMA New Zealand Senior Advisor on Māori issues was advised of the
application. Her comments form the basis of paragraphs 4.23 and 4.24 of this decision.
4
Consideration
Sequence of the Consideration
4.1
This application was considered by the Chief Executive of ERMA New Zealand under
delegated powers from the Authority (section 19(2)(e) of the HSNO Act).
4.2
In accordance with section 32 of the Act, the approach adopted when considering this
application was to confirm whether the application was for one of the purposes
specified in section 30, to identify and assess the risks and to determine whether the
substances could be adequately contained by controls to provide for each of the matters
specified in Part III of the Third Schedule of the Act.
Purpose of the Application
4.3
As the purpose amounts to “research and development on any hazardous substance”, I
consider that the application qualifies for consideration under section 30(ba) of the Act.
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Hazard Classification
4.4
I note that a containment application does not require a rigorous assessment of the
hazard classification but only sufficient understanding of the hazardous properties to
ensure that any risks can be managed by the containment controls.
4.5
The known hazardous properties of the substances and individual components and
confidential information relating to the composition of the substances were provided by
the applicant.
4.6
7CN, 7CE and 7CNE each consist of an aqueous solution of chelating agents, buffers
and surfactants.
4.7
The applicant has assessed the hazardous properties for the three substances and has
identified that these substances have toxic (acute toxicity and carcinogenicity), ecotoxic
(aquatic toxicity) and corrosive (eye and skin corrosion) properties.
4.8
I have reviewed the applicant’s hazard classifications and consider that they sufficiently
describe the hazards associated with the substances.
Identification and Evaluation of the Significant Risks of the Substances in
Containment
4.9
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential
risks of escape from containment under the headings of environmental, human health
and welfare and Māori issues and concerns.
4.10
The applicant addressed the risks within the context of the application.
4.11
The applicant advises that the substances have been formulated as cleaning agents to be
used in the food industry to clean stainless steel and non-stainless steel food processing
equipment.
4.12
The applicant states that all the components in the substances are currently used in the
cleaning industry in New Zealand. They are currently introduced into the cleaning
programme via a number of different formulations. The three substances have been
formulated with the aim of reducing water consumption and subsequent generation of
waste water during the cleaning process, by reducing the number of cleaning steps, as
well as improving the efficiency of the plant after it has been cleaned, increasing the
rate of production and hence reducing manufacturing costs.
4.13
The applicant states that the raw materials for 7CN, 7CE and 7CNE will be transported
to the Orica Chemnet Mount Maunganui small mix plant. Up to 10 tonnes of the
substances (aggregate quantity) will be blended at the plant in a bunkered mixing vessel,
before being packed into drums or IBC freight containers. These will be stored at the
Orica Chemnet site or at an approved third party store until required for trialling.
4.14
The applicant states that the substances will be transported to the trial site using a third
party operator. They will be stored in a bunkered area until the trial commences.
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4.15
The applicant states that 7CN, 7CE and 7CNE will be transferred from an IBC container
or drum to one of the nominated trial sites for trialling in the facility’s cleaning process.
Seven food manufacturing premises have been identified as possible trial sites.
4.16
The applicant advises that, during the cleaning process, each substance is diluted with
water and an alkali buffer to produce a solution of about 1% v/v of the substance and
0.5% v/v alkaline buffer. The applicant states that the plant is flushed with water once
the trial cleaning is complete. The spent cleaning solutions are discharged into the
plant’s waste water streams and are treated at the site’s biological effluent plant. Empty
packaging is returned to Orica Chemnet for washing and reuse.
Risks to the Environment
4.17
Exposure to the substances has the potential to result in adverse effects on aquatic
organisms, if released into waterways.
4.18
Taking into account the lifecycle of the substances outlined in paragraphs 4.13 to 4.16
(including the combination of dilution and effluent treatment before discharge), and the
controls and measures outlined in the application and in Appendix 1, effects on aquatic
organisms could arise from:
 An accident during manufacture, storage, use or transportation, resulting in release
of the substances into waterways
 Failure of the biological effluent treatment facility to adequately neutralise the spent
cleaning solution prior to discharge
 Failure to follow safety precautions or label instructions
4.19
I consider that, taking into account the proposed containment regime and controls in
place under other legislation, there are no significant risks to the environment.
Risks to Human Health and Welfare
4.20
Exposure to the substances has the potential to result in adverse effects on human health
and welfare, by oral, dermal, ocular or inhalation exposure.
4.21
Taking into account the lifecycle of the substances outlined in paragraphs 4.13 to 4.16,
and the controls and measures outlined in the application and in Appendix 1, adverse
effects on human health and welfare could arise from:
 An accident, resulting in exposure, during manufacture, storage, use or
transportation
 Failure to follow safety precautions or label instructions
4.22
I consider that, taking into account the proposed containment regime and controls in
place under other legislation, there are no significant risks to human health and welfare.
Māori issues and concerns
4.23
I have considered the potential Māori cultural effects of this application in accordance
with sections 6(d) and 8 of the HSNO Act 1996, and the assessment framework
contained in the ERMA New Zealand User Guide “Working with Māori under the
HSNO Act 1996”.
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4.24
On the basis of the information provided by the ERMA New Zealand Advisor on Māori
issues, I consider that the substances are unlikely to have an impact on the relationship
of Māori and their culture and traditions with their ancestral lands, water, sites, waahi
tapu, valued flora and fauna and other taonga. This is on the condition that the
substances are used in accordance with the controls established by the HSNO Act for
this application, and in accordance with any other relevant controls applying under other
legislation.
5
Containment and Controls
5.1
I have evaluated the adequacy of the containment arrangements of the applicant and
note that these cover the matters set out in Part III of the Third schedule of the Act,
being
 To limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances.
 To exclude organisms from a facility.
 To exclude unauthorized people from the facility.
 To prevent unintended release of the substances by experimenters working with the
substances.
 To control the effects of any accidental release of the substances.
 Inspection and monitoring requirements.
 Qualifications required of the person responsible for implementing the controls.
5.2
Controls listed in Appendix 1 will prevent exposure to the substances (such as through
the use of protective clothing by workers, and through manufacture and use in contained
facilities), thereby mitigating the likelihood of adverse effects on the human population
that could arise from the substances’ acute and chronic toxic properties and their skin
and eye corrosive properties.
5.3
Controls listed in Appendix 1 will ensure that waste from the trial facility is made nonhazardous (such as by dilution and through the use of the biological effluent treatment
facility), thereby mitigating the likelihood of adverse effects on aquatic organisms.
5.4
Additional controls are in place to protect the security of the trial facilities and the
integrity of the trial, and to ensure appropriate management of the manufacturing and
trial facilities.
5.5
Therefore, I am satisfied that with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, the substances can be adequately
contained.
6
Decision
6.1
I have considered this application under section 31 to import the hazardous substances
7CN, 7CE and 7CNE into containment, and pursuant to section 32, I am satisfied that
this application is for the purpose specified in section 30(ba).
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6.2
Having considered the risks associated with the lifecycle of 7CN, 7CE and 7CNE, I am
satisfied that the controls imposed, including those in place under other legislation, will
result in the substances being adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology I record that, in reaching this
conclusion, I have applied the criteria specified in section 32 of the Act.
6.4
I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substances;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques;
6.5
The application to manufacture into containment the hazardous substances 7CN, 7CE
and 7CNE are thus approved pursuant to section 31 of the Act, with controls as set out
in Appendix 1.
Bas Walker
Date
Chief Executive of ERMA New Zealand
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Appendix 1: List of controls that apply to the
hazardous substances 7CN, 7CE and 7CNE
1. A Management Plan shall be submitted to ERMA New Zealand prior to commencement
of the trial. This plan shall demonstrate how the manufacture and trialling of 7CN, 7CE
and 7CNE will be undertaken to comply with the information contained in the application
and with the controls in this Appendix.
2. Not withstanding the requirements of control 1 above, the trial shall comply with the
following controls.
3. 7CN, 7CE and 7CNE shall be blended and packaged at the Orica Chemnet small mix
plant at Mount Maunganui. The maximum aggregate quantity of 7CN, 7CE and 7CNE
that shall be manufactured is 10 tonnes.
4. Any spillage in the manufacturing area shall be securely retained, prior to being sent for
disposal in such a manner that ensures that contact with aquatic environments is
prevented.
5. The trials shall be carried out at the sites specified in the confidential section of the
application.
6. The substances shall not come into contact with any food products being manufactured at
the facilities.
7. The substances shall be securely packed and stored in suitable containers that comply
with the Hazardous Substances (Packaging) Regulations 2001, and shall be labelled in
accordance with the Hazardous Substances (Identification) Regulations 2001.
8. The transportation of the substances shall comply with The Land Transport Rule:
Dangerous Goods 1999.
9. No unauthorised persons are allowed into the Orica Chemnet site where the substances
are being manufactured.
10. No persons are to enter the trial premises without the permission of the property owners
or the Trial Director (refer to paragraph 16).
11. Trial sites shall be secured by security fencing and all potential access points shall be
sign-posted indicated that unauthorised access is not allowed.
12. Quarantine stickers shall be fixed to drums of 7CN, 7CE and 7CNE to ensure that they
are not used without supervision.
13. Unused material, used packaging and equipment, waste water and spillage residues shall
be securely retained, prior to being sent for proper decontamination or disposal at an
approved facility.
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14. Appropriate safety precautions necessary to provide safeguards against the substances’
acute and chronic toxic properties and skin and eye corrosive properties shall accompany
the substances at all stages of their lifecycle.
15. Relevant first aid measures for immediate action pending medical attention shall
accompany the substances at all stages of their lifecycle.
16. The person overseeing the manufacture of the substances and the trial shall be the Trial
Director, ie. the person nominated by Orica Chemnet to be in charge of the trial.
17. The Trial Director shall keep track of use and disposal of the substances.
18. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the
location, start, and completion of the trials.
19. If for any reason a breach of containment occurs, the Trial Director shall notify OSH and
ERMA New Zealand within 24 hours of the breach being detected.
20. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
21. The trial must be completed within three years of the date of this approval.
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