ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
6 May 2008
Application Code
HSC08004
Application Type
To import into or manufacture in containment hazardous substances
for export only purposes under Section 31 of the Hazardous
Substances and New Organisms Act 1996 (“the Act”)
Applicant
Nufarm Limited
Purpose of the Application
To import and manufacture agricultural chemicals in containment for
the purposes of exporting to overseas countries.
Date Application Received
19 March 2008
Consideration Date
6 May 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to manufacture in or import into containment Nufarm Export
Only Agrichemicals is approved with controls in accordance with the relevant
provisions of the Act and the HSNO (Methodology) Order 1998 (“the
Methodology”).
1.2
The substances have been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
Nufarm Export Only Agrichemicals
2 Legislative criteria for the application
2.1
The application was lodged pursuant to section 31. The decision was determined
in accordance with section 32, taking into account matters to be considered in
that section and additional matters specified under Part II of the Act and the
provisions of Part III of the Third Schedule of the Act. Unless otherwise stated,
references to section numbers in this decision refer to sections of the Act.
2.2
Consideration of the application followed the relevant provisions of the
Methodology. Unless otherwise stated, references to clauses in this decision
refer to clauses of the Methodology.
3 Application process
3.1
The application was formally received on 19 March 2008.
3.2
Evaluation of the application was undertaken by the ERMA New Zealand
project team which comprised the following staff members:
Haydn Murdoch
Elizabeth Morgan
Sekove Tinalevu
Noel McCardle
3.3
The applicant supplied the following documents:

3.4
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Acting Applications Manager (Hazardous
Substances)
the application.
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 Department of Labour (Workplace Group);
the New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
3.4.1 No responses were received.
3.5
The applicant was provided with a copy of the proposed controls for Nufarm
Export Only Agrichemicals and given the opportunity to comment on them. The
comments provided were taken into account in the setting of controls.
4 Consideration
Sequence of the consideration
4.1
In accordance with section 32, 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 substance could be adequately contained by controls to provide for each of
the matters specified in Part III of the Third Schedule of the Act.
4.2
This application was considered by the Chief Executive of ERMA New Zealand
under delegated powers from the Authority (section 19(2)(e)).
Purpose of the application
4.3
This application has been submitted to cover the import into containment of
agrichemicals (where the product may be down packed from bulk drums or IBCs
to smaller saleable packs before export) and contained manufacture of
agrichemicals for export to overseas markets.
4.4
The Nufarm Export Only Agrichemicals covered by this application will have a
classification within the range 3.1 B-D, 6.1 C-E, 6.3A or B, 8.3A, 6.4A, 6.5A or
B, 6.6A or B, 6.7A or B, 6.8A-C, 6.9A or B, Class 9; and they will not be
exported to the Pacific Islands.
ERMA New Zealand Decision: Application HSC08004
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4.5
It is considered that the purpose of the application qualifies it to be considered
under section 30(ca) as the substances will be formulated and packaged for
export to a destination outside New Zealand.
Life cycle of the substances
4.6
The Nufarm Export Only Agrichemicals will either be imported into
containment and repackaged before export or manufactured in containment
before export.
Importation into containment
4.7
The Nufarm Export Only Agrichemicals will be imported in sealed containers
with labels that comply with international transport requirements. The Nufarm
Export Only Agrichemicals will be accompanied by the relevant documentation.
The Nufarm Export Only Agrichemicals will remain in the import containers
during the subsequent road/rail transport to the storage facility at Nufarm
Limited in Otahuhu.
4.8
The Nufarm Export Only Agrichemicals will be down packed from bulk drums
or IBCs to smaller saleable packs and stored at Nufarm Limited facilities until
export overseas. Packaging and storage will comply with the relevant HSNO
controls for the substance. Disposal of any packaging will meet the requirements
of the Hazardous Substances (Disposal) Regulations 2001.
4.9
The transportation of the repackaged Nufarm Export Only Agrichemicals from
the storage facilities to the port of loading for export will be subject to the
relevant New Zealand transport legislation and the HSNO controls applicable to
the identified hazards.
Manufacture in containment
4.10
Ingredients will be purchased by the manufacturing plant and supplied in
accordance with New Zealand transport legislation requirements.
4.11
The Nufarm Export Only Agrichemicals will be manufactured at Nufarm
Limited manufacturing facilities for export purposes only. Waste from the
manufacturing process or contaminated or surplus substance will be either
treated to render the substance non-hazardous before disposal or exported from
New Zealand. Disposal in New Zealand will meet the requirements of the
Hazardous Substances (Disposal) Regulations 2001.
4.12
The manufactured Nufarm Export Only Agrichemicals will be packed and
securely stored at the manufacturing facility. Packaging and storage will comply
with the relevant HSNO controls for the substance. Disposal of any packaging
will meet the requirements of the Hazardous Substances (Disposal) Regulations
2001.
4.13
The transportation from the manufacturing site to the port of loading for export
will be subject to the relevant New Zealand transport regulations and the HSNO
controls applicable to the identified hazards.
ERMA New Zealand Decision: Application HSC08004
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5 Hazardous properties of the substances
5.1
Nufarm Limited has agreed that Nufarm Export Only Agrichemicals will be
limited to those with classifications within the following boundaries: 3.1 B-D,
6.1 C-E, 6.3A or B, 8.3A, 6.4A, 6.5A or B, 6.6A or B, 6.7A or B, 6.8A-C, 6.9A
or B, or Class 9.
6 Controls
6.1
Nufarm Limited have proposed a set of controls for the management of the
repackaging and manufacture of export only agrichemicals in containment at
their storage and manufacturing facilities. The following risk assessment is
based on the assumption that these controls together with others proposed by the
Agency as set out in Appendix 1 are in place.
7 Identification and assessment of the significant risks of
the importation and manufacture of Nufarm Export
Only Agrichemicals
7.1
The applicant has identified and assessed potential risks associated with the
importation and manufacture of Nufarm Export Only Agrichemicals and detailed
proposals for, and impacts of, risk management. The project team has reviewed
the applicant’s assessment of the risks to the environment, human health and
welfare, and Māori issues and concerns as set out below.
Risks to the environment from the importation and manufacture of
Nufarm Export Only Agrichemicals
7.2
Given the potential ecotoxic nature of the Nufarm Export Only Agrichemicals,
the project team considers them to have the potential to cause adverse effects to
the biological environment if they enter the aquatic or terrestrial environments.
7.3
Due to the substances’ export-only status it is noted that the lifecycle stages
occurring in New Zealand are limited; refer paragraphs 4.6 to 4.13. However, if
an incident was to occur during one of those lifecycle stages, for example,
transport to the port or shipping within New Zealand waters, there may be
significant effects on the environment. It is noted that the overall impact would
be largely dependent on the volume of the substance released and the
susceptibility of the environment and organisms exposed.
7.4
In determining the overall level of risk posed to the environment while the
substances are in New Zealand, the project team has taken several factors into
account. These factors include the specialised nature of the manufacturing and
repackaging facilities; the trained, informed and equipped nature of the staff
handling the substances; emergency management provisions; and the additional
requirements of relevant legislation. An example of one of these factors is the
provision of bunding to contain spills during repackaging, manufacture and
storage, and the packaging provisions that will act to limit the quantities released
during a transport incident.
ERMA New Zealand Decision: Application HSC08004
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7.5
Given the factors described above, the project team considers that no significant
risks will be posed to the environment.
Risks to human health from the importation and manufacture of
Nufarm Export Only Agrichemicals
7.6
The project team notes that exposure to the Nufarm Export Only Agrichemicals
potentially poses a range of hazards to human health. The adverse effects may
occur through one-off or repeated exposures.
7.7
It is considered that workers involved in handling the substances on a regular
basis may be susceptible to both one-off and repeated exposures, while
emergency workers and members of the public are only likely to experience oneoff (acute) exposures and are subsequently not at risk from the chronic hazards
posed by the substances.
7.8
In determining the overall level of risk posed to human health while the
substances are in New Zealand, the project team has taken several factors into
account. These factors include the specialised nature of the manufacturing and
repackaging facilities; the trained, informed and equipped nature of the staff
handling the substance; its highly restricted accessibility; and the additional
requirements of relevant legislation.
7.9
Given the factors outlined above, the project team considers it unlikely that any
significant risks will be posed to human health or welfare.
Māori issues and concerns about the importation and manufacture of
Nufarm Export Only Agrichemicals
7.10
The project team considered the potential Māori cultural effects in accordance
with clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8. In addition, the project
team applied the assessment framework contained in the ERMA New Zealand
User Guide “Working with Māori under the HSNO Act 1996” in consideration
of this application.
7.11
As Nufarm Export Only Agrichemicals have the potential to present several
toxicity and ecotoxicity hazards, the project team considers that the potential
exists for the substances to deteriorate the mauri of taonga flora and fauna, the
environment and the general health and well-being of individuals and the
community. In addition the potential exists for Nufarm Export Only
Agrichemicals to inhibit the ability of iwi/Māori to fulfil their role as kaitiaki,
particularly in relation to the guardianship of waterways.
7.12
After careful consideration of the risks associated with the contained
manufacture and importation of Nufarm Export Only Agrichemicals, the project
team does not consider that any significant adverse effects are likely to occur to
Māori culture or traditional relationships with their ancestral lands, water, sites,
wāhi tapu, valued flora and fauna or other taonga. This assessment is made on
the condition that the substances are imported, manufactured, handled, stored
and transported in accordance with the explicitly stated HSNO controls, and any
controls stipulated in other applicable Acts. However, should an accident result
in the contamination of waterways or the environment, it is suggested that
Nufarm Limited notify the appropriate authorities including the relevant iwi
ERMA New Zealand Decision: Application HSC08004
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authorities in that region. This action should include advising them of the
contamination and the measures taken to contain and remedy it.
International considerations
7.13
Due to the limited scope of the “containment” approval pathway provided for
export-only substances and the potential variability in environmental conditions
and legislative requirements in importing nations, the project team has not
conducted any risk assessment on lifecycle stages that will occur outside of New
Zealand.
8 Containment and controls
8.1
The project team has evaluated the adequacy of the containment arrangements
proposed by the applicant and has prepared the controls listed in Appendix 1,
and notes that these cover the matters set out in Part III of the Third Schedule of
the Act, being:





8.2
to limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances (for example, control 6 c);
to exclude organisms and unauthorised people from a facility (for
example, control 6 a);
to control the effects of any accidental release of the substance (for
example, control 18);
inspection and monitoring requirements (for example, control 8); and
qualifications required of the person responsible for implementing the
controls (for example, control 15).
The project team is satisfied that, with adherence to the controls listed in
Appendix 1 and those controls in place under other legislation, Nufarm Export
Only Agrichemicals can be adequately contained when in New Zealand.
9 Decision
9.1
Under section 32(1), I may approve a containment application made under
section 31, if the application is for one of the purposes specified in section 30
and if I am satisfied that the substance can be adequately contained.
9.2
Under section 32(2), an approval must include controls that provide for each of
the applicable matters specified in the Third Schedule to the Act and that provide
for other matters that give effect to the purpose of the Act.
9.3
I have considered the application made by Nufarm Limited, to manufacture in
and import into containment Nufarm Export Only Agrichemicals for export only
purposes.
9.4
I am satisfied that the application is for the purpose of “formulating, relabelling,
repackaging or storing any hazardous substance for export to a destination
outside New Zealand” as provided for in section 30(ca).
9.5
I have considered the risks associated with the substances’ lifecycle in
New Zealand, as evaluated by the project team. As a result, I am satisfied that
the controls proposed under section 32(2), as set out in Appendix 1, and the
requirements of other legislation will result in the substances being adequately
contained.
ERMA New Zealand Decision: Application HSC08004
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9.6
As well as considering the matters set out in section 32, I have also applied the
following criteria in the Methodology in reaching my decision:





9.7
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.
I am satisfied that the requirements of section 32 have been met and thus
approve the application made by Nufarm Limited to manufacture in and import
into containment Nufarm Export Only Agrichemicals for export only purposes.
This approval is subject to the controls as set out in Appendix 1.
Rob Forlong
Date: 6 May 2008
Chief Executive of ERMA New Zealand
Substance Identifier:
ERMA New Zealand Approval
Code:
Nufarm Export Only Agrichemicals
HSC000330
ERMA New Zealand Decision: Application HSC08004
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APPENDIX 1:
List of controls that apply to manufacture of Nufarm Export
Only Agrichemicals
Scope
1. This approval covers the import into containment and contained manufacture,
packaging, storage and transport of agrichemicals (within the boundaries of 3.1 B-D,
6.1 C-E, 6.3A or B, 8.3A, 6.4A, 6.5A or B, 6.6A or B, 6.7A or B, 6.8A-C, 6.9A or B,
or Class 9) by Nufarm Limited in New Zealand for export-only purposes.
2. This approval excludes:
a. the use of Nufarm Export Only Agrichemicals in New Zealand.
b. the manufacture for direct export from New Zealand to the Pacific Islands.
c. any agrichemical which contains a substance that appears on the Chief
Executive initiated reassessment priority list as listed in Appendix 2.
d. any substance which is listed under the Stockholm Convention or the
Rotterdam Convention.
3. This approval remains in force for five years from the date of this decision.
Importation
4. Nufarm Limited may import, in containment, Nufarm Export Only Agrichemicals for
the purpose of repackaging to saleable packages before export.
Manufacture
5. Nufarm Limited may manufacture, in containment, the substances identified as
Nufarm Export Only Agrichemicals, at its secure manufacturing facility in Otahuhu,
as nominated in the application.
6. The facility used to store the hazardous components and repackage, manufacture and
store Nufarm Export Only Agrichemicals shall:
a. be managed to exclude unauthorised persons from accessing the facility;
b. be managed to exclude unwanted organisms from the facility;
c. provide mechanisms to prevent the unintended release of the substance, for
example secondary containment;
d. have an emergency management plan in place to deal with spillage events.
Packaging
7. Nufarm Export Only Agrichemicals and their hazardous components shall be securely
packaged in suitable containers that comply with the Hazardous Substances
(Packaging) Regulations 2001.
ERMA New Zealand Decision: Application HSC08004
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Notification and inspection
8. If for any reason a breach of containment occurs in New Zealand, Nufarm Limited
shall, within 24 hours of the breach being detected:
a. notify Department of Labour and ERMA New Zealand;
b. inform the relevant iwi authority, if the breach in containment results in
contamination of any waterbody.
9. Documentation regarding the substances’ lifecycle, notwithstanding its confidential
nature, shall be available for inspection by any authorised enforcement officer, upon
request.
10. Prior to the commencement of importation or manufacture, the applicant shall provide
ERMA New Zealand with a Notification to Import/Manufacture. A Notification to
Import/Manufacture shall contain:
a. The composition of the substance;
b. An SDS, for the substance and its hazardous components containing a HSNO
hazard classification based upon the information contained therein;
c. A registration approval notification from an importing country (or evidence
from an importing country competent authority of an accepted application to
register).
Storage
11. Nufarm Export Only Agrichemicals and their hazardous components shall be securely
stored in accordance with good practice within secure facilities. This may be
demonstrated by compliance with the Code of Practice for the Management of
Agrichemicals NZS 8409: 2004.
Transport
12. Nufarm Export Only Agrichemicals and their hazardous components shall be
transported in accordance with good practice and where appropriate in compliance
with the relevant requirements of the Land Transport Act 1998, the Civil Aviation
Act 1990 or the Maritime Transport Act 1994.
Labelling
13. Packages containing Nufarm Export Only Agrichemicals and their hazardous
components shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001 or in accordance with the alternative labelling
requirements as set out below.
Alternative labelling requirements for export-only substances
Individual packages
1) The packaging of single containers of Nufarm Export Only Agrichemicals
and their hazardous components, whether contained within a multiple
package or not, may comply with the labelling requirements of a) the Food and Agricultural Organisation of the United Nations (FAO),
Guidelines on Good Labelling Practice for Pesticides, 1995, or
ERMA New Zealand Decision: Application HSC08004
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b) the Globally Harmonised System; or
c) a relevant regulatory authority in the country of destination.
2) If individual packages comply with (1), they need not comply with –
a) regulations 11 and 12 of the Hazardous Substances (Disposal)
Regulations 2001; and
b) regulations 6 to 8 of the Hazardous Substances (Emergency
Management) Regulations 2001; and
c) regulations 6, 7, 9, 14, 18, 20, 25, or 36(8) of the Hazardous Substances
(Identification) Regulations 2001.
Multiple packaging
1) These requirements apply to Nufarm Export Only Agrichemicals and their
hazardous components when in multiple packaging.
2) The outer packaging of a multiple package must bear:
a) the priority identifier information required by regulations 9, and 14 of
the Hazardous Substances (Identification) Regulations 2001; or
b) the labelling requirements Globally Harmonised System; or
c) the labelling or marking required by
i) Land Transport Rule 45001: Dangerous Goods 2005; or
ii) Civil Aviation Rule 92: Carriage of Dangerous Goods; or
iii) Maritime Rule 24A: Carriage of Cargoes - Dangerous Goods; or
d) the pictogram for “Dangerous in the Environment” as described in
directive 92/32/EEC (instead of identifier requirements of regulations 9
and 20); or
e) the relevant class or subclass label assigned by the UN Model
Regulations.
3) The outer packaging of a multiple package must be identified with enough
information to enable its New Zealand supplier or manufacturer to be
contacted, either in person or by telephone.
4) The outer packaging of a multiple package shall not have on its packaging,
or with it, any information suggesting that it belongs to a class or subclass it
does not in fact belong to.
5) The outer packaging of a multiple package which complies with (2) to (4)
need not comply with regulations 18, 20, 25 and 30 of the Hazardous
Substances (Identification) Regulations 2001.
6) Any requirement to label the outer packaging of a multiple package as
containing a substance that is hazardous to the environment/ecotoxic, as
specified in subclauses (2) to (4), is omitted when the substance is stored in
New Zealand in a secure warehouse or other secure storage facility owned,
operated or otherwise under the control of the manufacturer or the shipping
agent prior to exportation from New Zealand.
ERMA New Zealand Decision: Application HSC08004
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Safety data sheets
14. A Safety Data Sheet (SDS), compliant with the Hazardous Substances (Identification)
Regulations 2001 shall be present with the substances at all stages of their lifecycles
in New Zealand. The SDS shall be available within 10 minutes.
Handling of the substances
15. Persons handling Nufarm Export Only Agrichemicals and their hazardous
components during manufacture and packaging shall have received training in the
safe handling and management of hazardous chemicals or be under the supervision of
persons with this knowledge.
16. Appropriate Personal Protective Equipment (PPE), for example, safety glasses, gloves
and protective clothing shall be worn by persons handling the substances during
manufacture, packaging and disposal.
17. Workplace Exposure Standards set by the Department of Labour for any of the
components of Nufarm Export Only Agrichemicals shall apply.
Emergency management
18. Nufarm Limited shall comply with the emergency management provisions as required
by regulations 25 to 42 of the Hazardous Substances (Emergency Management)
Regulations 2001.
Disposal
19. Disposal of Nufarm Export Only Agrichemicals will involve either treating to render
the substances non-hazardous before disposal or exportation from New Zealand.
20. Any rinsate, washings, or residue generated during the manufacture of Nufarm Export
Only Agrichemicals shall be treated or disposed of in a manner compliant with
Hazardous Substances (Disposal) Regulations 2001, for the hazards posed.
ERMA New Zealand Decision: Application HSC08004
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APPENDIX 2:
List of substances that are excluded from the scope of this
approval.
Endosulfan and its formulations
Azinphos methyl and its formulations
Methyl-parathion and its formulations
Pentachlorophenol and its salts
2,4-D, its salts and esters and formulations containing these substances
Acephate and its formulations
Anti-fouling paints
Benomyl and carbendazim and their formulations
Carbaryl and its formulations
Chlorothalonil and its formulations
Chlorpyrifos and its formulations
Diazinon and its formulations
Dichlorvos and its formulations
Dimethoate and its formulations
Fenitrothion and its formulations
Methamidophos (60%) and its formulations
Methyl bromide
Methyl-arsenic acid and its formulations
Paraquat and its formulations
Trichlorfon and its formulations
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