ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
24 December 2007
Application Code
HSC07020
Application Type
To manufacture hazardous substances in containment for export only
purposes under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant
Dow AgroSciences (NZ) Limited
Purpose of the Application
To import or manufacture Export Only Pesticides under containment
for export where these substances fall within the hazard classification
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, or Class 9.
Date Application Received
6 August 2007
Consideration Date
24 December 2007
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to manufacture export-only pesticides in containment 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:
Dow AgroSciences Export-only Pesticides
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 6 August 2007.
3.2
Evaluation of the application was undertaken by the ERMA New Zealand
project team which comprised the following staff members:
Noel McCardle
Sekove Tinalevu
Beth Dye
3.3
The applicant supplied the following documents:

3.4
Senior Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
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:
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the Ministry of Health;
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
Due to delays in considering this application, the Authority, with the applicant’s
consent, waived the requirement to consider this application by 17 September
2007 for an additional 67 working days.
3.6
The applicant was provided with a copy of the proposed controls for Export-only
Pesticides 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 contained manufacture of
export-only pesticides for export to overseas markets.
4.4
Manufacture in this context means formulate from an imported pesticide active
ingredient and other components which will have approvals under an ERMA
New Zealand Group Standard. The export-only pesticides 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
ERMA New Zealand Decision: Application HSC07020
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they will not be exported to the Pacific Islands. Export-only pesticides in the
context of this application include ready to use adjuvants used in conjunction
with a pesticide.
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 applicant intends to manufacture the export-only pesticidal formulations in
containment at its specialised and dedicated chemical formulation plant in New
Plymouth.
4.7
The applicant has stated that the active ingredient components of the pesticides
will be manufactured overseas and will be imported and transported by road or
rail direct to the manufacturing site of Dow AgroSciences in New Plymouth.
The importation will be in sealed containers with labels that comply with
international transport requirements. If the material is a dangerous good it will
be accompanied by the relevant documentation. The material will remain in the
import containers during the subsequent road/rail transport to the Dow
AgroSciences storage site in New Plymouth. This material will be used at the
formulation site only.
4.8
The non-active components will be manufactured overseas and supplied to Dow
AgroSciences by their New Zealand distributors by road/rail to the
manufacturing site. The importation will be in sealed containers with labels that
comply with international transport requirements. If the material is a dangerous
good it will be accompanied by the relevant documentation. The material will
remain in the import containers during the subsequent road/rail transport to the
Dow AgroSciences storage site in New Plymouth. This material will be used at
the formulation site only.
4.9
The export-only pesticides will be manufactured in batches, with each batch
involving the mixing of the constituent components under ambient or heated
conditions. Pressure may be required in the manufacturing process for some
substances. Quality control procedures will be undertaken prior to the substance
being packed.
4.10
The export-only pesticides will be manufactured at the Dow AgroSciences
pesticide manufacturing plant for export purposes only. The transportation from
the manufacturing site to the port of loading for export will be subject to the
current land transport regulations and the HSNO controls applicable to the
identified hazards. Packaging and storage would also comply with the relevant
HSNO controls for the substance.
5 Hazardous properties of the substances
5.1
Dow AgroSciences has proposed that the substances 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.
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6 Controls
6.1
Dow AgroSciences have proposed a set of controls for the management of the
manufacture of export-only pesticides in containment at their New Plymouth
site. 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 manufacture of export-only pesticides
7.1
The applicant has identified and assessed potential risks associated with the
manufacture of export-only pesticides 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.
7.2
As indicated in Paragraphs 4.7 and 4.8, the components used in the manufacture
of export-only pesticides will be manufactured overseas and will be imported
and transported by road or rail direct to the applicant’s manufacturing site in
New Plymouth. The ingredients will be imported in sealed containers with
labels that comply with international transport requirements and will be
accompanied by the relevant documentation. The ingredients will remain in the
import containers during the subsequent road/rail transport to the applicant’s
storage site in New Plymouth.
7.3
Taking into account the transport regulations and controls such as packaging,
identification and emergency management controls that will be imposed under
this approval, it is considered that the importation of the active ingredient into
containment in New Zealand will not pose any significant risks to the
environment or human health and safety.
Risks to the environment from the manufacture of export-only
pesticides
7.4
Given the ecotoxic nature of the export-only pesticides, 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.
7.5
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 4.10. 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.
7.6
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
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
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bunding to contain spills during manufacture and storage, and the packing
provisions that will act to limit the quantities released during a transport
incident.
7.7
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 manufacture of export-only pesticides
7.8
The project team notes that exposure to the export-only pesticides poses a range
of hazards to human health. The adverse effects may occur through one-off or
repeated exposures.
7.9
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.
7.10
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
facilities; the trained, informed and equipped nature of the staff handling the
substance; its highly restricted accessibility; and the additional requirements of
relevant legislation.
7.11
Given the factors outlined above, the project team considers it unlikely that any
significant risks will be posed to human health or welfare through the
manufacture of export-only pesticides in New Zealand.
Māori issues and concerns about manufacturing export-only pesticides
7.12
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.
7.13
As Dow AgroSciences Export-only Pesticides present several toxicity and
ecotoxicity hazards the project team considers that the potential exists for the
substance 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 Dow AgroSciences Export-only Pesticides to
inhibit the ability of iwi/Māori to fulfil their role as kaitiaki, particularly in
relation to the guardianship of waterways.
7.14
After careful consideration of the risks associated with the contained
manufacture of Dow AgroSciences Export-only Pesticides purposes, 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 compounds are 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 Dow
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AgroSciences (NZ) Limited notify the appropriate authorities including the
relevant iwi authorities in that region. This action should include advising them
of the contamination and the measures taken to contain and remedy it.
International considerations
7.15
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:
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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, export-only
pesticides can be adequately contained within 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 Dow AgroSciences (NZ) Limited, to
manufacture the Dow AgroSciences export-only pesticides in containment 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.
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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:
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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 Dow AgroSciences (NZ) Limited to
manufacture Dow AgroSciences export-only pesticides in containment for
export only purposes. This approval is subject to the controls as set out in
Appendix 1.
Rob Forlong
Date 24 December 2007
Chief Executive of ERMA New Zealand
Substance Identifier:
ERMA New Zealand Approval
Code:
Dow AgroSciences Export-only Pesticides
HSC000304
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APPENDIX 1:
List of controls that apply to manufacture of Dow AgroSciences
export-only pesticides
Scope
1. This approval covers the contained manufacture, packing, storage and transport of
pesticides (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 Dow AgroSciences (NZ)
Limited in New Zealand for export-only purposes.
2. This approval excludes:
a. the use of Dow AgroSciences Export-only pesticides in New Zealand.
b. the manufacture for direct export from New Zealand to the Pacific Islands.
c. any export-only pesticide which is a formulation that appears on the Chief
Executive initiated reassessment priority list as listed in Appendix 2 and the
formulation contains a derivative of a substance listed that is not already
approved by the Authority.
3. This approval remains in force for five years from the date of this decision.
Importation
4. Dow AgroSciences (NZ) Limited may import, in containment, the hazardous
components used to manufacture Dow AgroSciences Export-only Pesticides at its
manufacturing facility in New Plymouth.
Manufacture
5. Dow AgroSciences (NZ) Limited may manufacture, in containment, the substances
identified as Dow AgroSciences Export-only Pesticides, at its secure manufacturing
facility in New Plymouth, as nominated in the application.
6. The facility used to store the hazardous components and manufacture and store
export-only pesticides 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. Dow AgroSciences Export-only Pesticides and their hazardous components shall be
securely packed in suitable containers that comply with the Hazardous Substances
(Packaging) Regulations 2001.
Notification and inspection
8. If for any reason a breach of containment occurs in New Zealand, Dow AgroSciences
(NZ) Limited shall, within 24 hours of the breach being detected:
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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 manufacture, Dow AgroSciences shall provide ERMA
New Zealand with a Notification to Manufacture. A Notification to Manufacture
shall contain:
a. The confidential composition of the substance;
b. An SDS, for the export only pesticide 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. The export-only pesticides 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. The export-only pesticides 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 Dow AgroSciences Export-only Pesticides 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 Dow AgroSciences Export-only
Pesticides 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
b) the Globally Harmonised System; or
c) a relevant regulatory authority as recognised by ERMA New Zealand in
the country of destination.
i) for Dow AgroSciences Export-only Pesticides the labelling that meets
the requirements of the Australian Pesticides and Veterinary
Medicines Authority (APVMA) is recognised by ERMA New Zealand.
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ii) For imported hazardous components, labels that meet the
requirements of Australia, USA and the EU for the transport of
chemicals.
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 Dow AgroSciences Export-only Pesticides 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.
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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 Dow AgroSciences Export-only Pesticides and their hazardous
components during manufacture and packing 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, packing and disposal.
17. Workplace Exposure Standards set by the Department of Labour for any of the
components of Dow AgroSciences Export-only Pesticides shall apply.
Emergency management
18. Dow AgroSciences (NZ) 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. If Dow AgroSciences Export-only Pesticides or their hazardous components require
disposal in New Zealand, Dow AgroSciences shall dispose of them in a manner
compliant with the requirements of the Hazardous Substances (Disposal) Regulations
2001.
20. Any rinsate, washings, or residue generated during the manufacture of Dow
AgroSciences Export-only Pesticides shall be treated or disposed of in a manner
compliant with Hazardous Substances (Disposal) Regulations 2001, for the hazards
posed.
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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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