ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
May 2007
Application Code
HSC07013
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous Substances
and New Organisms Act 1996 (the Act)
Sumitomo Chemical Australia Pty Ltd
Applicant
Purpose of the Application
SCAL-5016: To assess efficacy, phytotoxicity and crop
residues of SCAL-5016 in glasshouse and specific field crops.
Date Application Received
16 April 2007
Consideration Date
24 May 2007
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of Decision
1.1
The application to import into, or manufacture in, containment the hazardous
substance, SCAL–5016, is approved with controls in accordance with the relevant
provisions of the Act and the HSNO (Methodology) Order 1998 (the Methodology).
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
SCAL–5016
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 31. The decision was determined in
accordance with section 32, taking into account additional matters to be considered in
that section and 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 16 April 2007.
3.2
Project Team:
Brendon Noonan
Advisor (Hazardous Substances)
Sekove Tinalevu
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit
Report review and sign-out by:
Beth Dye
Applications Manager (Hazardous Substances).
3.3
The applicant supplied the following documents:
 the application; and
 confidential appendices including formulation data, safety data sheets for the
components, a Management Plan and a Project Plan.
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 Department of Labour (Workplace Group);
 the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for SCAL–5016 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
This application was considered by the Chief Executive of ERMA New Zealand under
delegated powers from the Authority (section 19(2)(e)).
4.2
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.
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Purpose of the application
4.3
The purpose of the application is to enable the import of SCAL–5016 so that studies
on efficacy, crop selectivity and residue decay may be carried out in the New Zealand
situation. The information generated will also form part of the data to support future
applications under the ACVM Act.
4.4
As the purpose amounts to “research and development on any hazardous substance”,
the Project Team considers that the application qualifies for consideration under
section 30(ba).
Life-cycle
4.5
The applicant intends to import a maximum of 10 litres of SCAL–5016 into
New Zealand. Nufarm New Zealand Limited will conduct the trials on behalf of the
applicant, Sumitomo Chemical Australia. Once imported the substance will be
securely stored until required for the trials. Trialling is expected to occur over a three
year period.
4.6
The trials will typically be conducted in glasshouses; however, certain outdoor crops
may also be included. The trials will involve replicated plots that are dedicated to the
trials and are buffered from commercial crops. Application of the substance will be
carried out in accordance with NZS8409:2004 Code of Practice for the Management
of Agricultural Chemicals and handheld spray equipment will be used.
4.7
The applicant has also specified a number of provisions relating to the containment of
the substance and protection of workers handling and applying the substance. These
are set out in the trial Management Plan.
Hazardous properties
4.8
The Project Team notes that a containment application only requires sufficient
understanding of the hazardous properties to ensure that any risks can be managed by
the containment controls. The scope of the hazard information will often be limited
for containment applications, as the substance will be experimental and may not be
commercialised.
4.9
The applicant has provided an assessment of the HSNO hazards posed by
SCAL–5016 and considers that it triggers the thresholds for 3.1D flammable liquid and
9.1A aquatic ecotoxicity. Although the applicant does not consider that SCAL–5016
poses any human toxicity hazards the data provided suggests that some toxicity
thresholds would be triggered and that human exposure to the substance should be
minimised. It is noted that the applicant has not provided any data in relation to
mutagenic/genotoxic effects, carcinogenicity, reproductive/developmental effects or
target organ/systemic toxicity.
4.10
The Project Team has reviewed the summary data and other information supplied by
the applicant and considers that the information is sufficient to determine that any
risks posed within the defined life-cycle of the substance in New Zealand can be
managed through the application of controls.
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Identification and evaluation of the significant risks of the substance in
containment
4.11
The applicant has identified and assessed potential risks 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
4.12
If released into the environment, the substance has the potential to result in adverse
effects within the environment.
4.13
On the basis of the life-cycle of the substance, adverse environmental effects could
arise from:
 an accident during storage, use or transportation, resulting in release of the
substance;
 failure to follow the correct operational procedures as set out in the controls and
containment system as described in the application, resulting in release of the
substance; or
 failure to follow correct disposal procedures.
4.14
The Project Team notes that limited quantities of the substance will be imported and
released into containment for field trials (i.e. up to 10 litres).
4.15
The Project Team considers that, taking into account the hazardous properties of the
substance, the quantities involved, the containment controls in Appendix 1 and
controls in place under other legislation, there are no significant risks to the
environment from this trial.
Risks to human health and welfare
4.16
The Project Team considers that adverse effects to human health and welfare may
result from exposure(s) to the substance, given the level of detail and related
uncertainty involved in studies conducted for experimental substances such as
SCAL–5016.
4.17
On the basis of the life-cycle of the substance outlined in paragraph 4.5-4.7, adverse
effects could arise from:
 an accident during storage, use or transportation, resulting in release of the
substance;
 failure to follow the correct operational procedures as set out in the controls and
the containment system, resulting in personnel exposure while contained, or
bystander exposure if released; or
 failure to follow correct disposal procedures.
4.18
The Project Team considers that there are no significant risks to human health and
welfare, given the properties of the substance, the quantities involved, the containment
regime proposed by the applicant, the containment controls in Appendix 1 and
controls in place under other legislation.
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Māori issues and concerns
4.19
The Project Team has considered this application in accordance with clauses 9(b)(i)
and 9(c)(iv) and sections 6(d) and 8. In addition, the Project Team used the
framework contained in the ERMA New Zealand user guide “Working with Māori
under the HSNO Act 1996” to assess this application.
4.20
The applicant has classified SCAL–5016 as being ecotoxic in the aquatic environment
(9.1A) and as being flammable (3.1D). Thus, there is the potential that this substance
could negatively impact Māori and, or, the mauri of iwi, cultural tāonga and the
environment.
4.21
The Project Team has completed its assessment of the application, and has identified
the risks and the appropriate controls necessary to mitigate the substance’s potential
physical, toxic and ecotoxic properties after careful consideration of the following:
 storage of SCAL–5016;
 packaging, product labelling, handling and transportation procedures; and
 appropriately supervised containment trial use.
4.22
Based on this assessment, the Project Team is unaware of any impacts that the SCAL–
5016 could have on Māori culture, or, on our traditional relationships with ancestral
lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. The Project
Team has no evidence to suggest that the controlled containment trial use of the
SCAL–5016 will breach the principles of the Treaty of Waitangi and see no
requirement for the applicant to consult with Māori regarding this application.
4.23
This assessment is made on the condition that the substance is handled, blended,
stored, transported, used and disposed of, in accordance with the explicitly stated
HSNO controls, and any controls stipulated in other applicable Acts. However,
should inappropriate use, or an accident, result in the contamination of waterways or
the environment, it is suggested that the applicant 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.
5 Containment and controls
5.1
The Project Team has evaluated the adequacy of the containment arrangements
proposed by the applicant and 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:
 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
substance;
 to control the effects of any accidental release of the substance;
 inspection and monitoring requirements; and
 qualifications required of the person responsible for implementing the controls.
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5.2
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, SCAL–5016 can be adequately
contained.
6 Decision
6.1
I have considered this application made under section 31 and, pursuant to section 32, I
am satisfied that this application is for the purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of SCAL–5016, I am satisfied
that the controls imposed, including those in place under other legislation, will result in
the substance being adequately contained.
6.3
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have
applied the criteria specified in section 32.
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 import into, or manufacture in, containment the hazardous
substance SCAL–5016 is thus approved pursuant to section 32, with controls as set
out in Appendix 1.
28 May 2007
Rob Forlong
Date:
Chief Executive of ERMA New Zealand
Substance Identifier
ERMA New Zealand Approval Code:
SCAL–5016
HSC000277
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Appendix 1: List of controls that apply to the hazardous
substance SCAL–5016
Scope
1.
This approval covers:
a.
the contained importation of a maximum of 15 litres of the substance
identified as SCAL–5016, as defined in the application.
b.
the contained field trialling of SCAL–5016 by Nufarm New Zealand Limited
on behalf of the applicant, Sumitoto Chemical Australia.
c.
the contained storage of SCAL–5016 for the period of this approval.
2.
This approval remains in place for five years from the date of this decision.
3.
This approval specifically excludes;
a.
the application of SCAL–5016 into or onto water; and
b.
the aerial application of SCAL–5016; and
4.
All life cycle stages from manufacture to disposal shall be undertaken in accordance
with the information provided by the applicant with their application. Modification of
this information may be approved in writing by ERMA New Zealand providing that it
complies with the following controls.
5.
Notwithstanding the requirements of control 4, the importation and trialling of
SCAL–5016 shall also comply with the following controls.
Importation and Transport
6.
The substance shall be transported in compliance with any relevant requirements of
the Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 or the
Maritime Transport Act 1994.
Packaging and information
7.
The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
8.
Packages shall be labelled with the following information;
a.
the unique identifier for the substance; and
b.
the “hazard pictograms” and “hazard statements” for the known hazards of the
substance; and
c.
the signal word “WARNING” followed by the statement “substance may pose
hazards additional to those listed on the label”; and
d.
a list of mitigation measures that should be taken when handling the substance
to limit exposure of people or the environment; and
e.
instruction that the substance must be returned in its original container to
Nufarm New Zealand Limited; and
f.
instruction on the correct disposal for the empty container; and
g.
enough detail to contact Nufarm New Zealand Limited either in person or by
telephone.
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9.
The information provided on the label shall be provided in a manner compliant with
regulations 32-35 and 36(1)-(7) (inclusive) of the Hazardous Substances (Identification)
Regulations 2001.
10.
A 16 heading layout Safety Data Sheet, compliant with the Hazardous Substance
(Identification) Regulations 2001, shall accompany the substance and be held at the
each trial site during the period of the trial.
Storage
11.
SCAL–5016 shall be stored securely; this may be achieved through compliance with
the Code of Practice for the Management of Agrichemicals NZS 8409: 2004.
General handling of the substances
12.
Appropriate personal protective equipment (PPE), for example, safety glasses, gloves,
respiratory mask and protective clothing shall be worn when handling the substance
during mixing, loading, use and disposal.
Trial Conditions
13.
The trials may be carried out at locations that have not yet been defined provided that;
prior to the trials commencing, the applicant;
a.
has written permission from the owner of the land to carry out the trials; and
b.
has notified ERMA New Zealand in writing of the locations in accordance with
Control 28.
14.
Access to the trial sites shall be by permission of the Trial Director1, or nominated
researcher.
15.
The trial site boundaries shall be clearly marked and distinctly visible from outside the
trial site throughout the life of the trials.
16.
The trial sites shall be signed indicating that unauthorised access is not permitted, that
the site is subject to a trial, and that fruit or plant matter should not be removed or be
consumed.
17.
During the field trials the substance shall be under the control of experimental staff
who —
a.
are experienced in the handling and application of pesticides under test
conditions using the specified equipment; and
b.
have been made aware of the study protocol and the controls in place in order
to adequately manage the substance and the emergency management
provisions.
18.
The substance shall be mixed, diluted and prepared prior to application in accordance
with the relevant sections of the Code of Practice for the Management of
Agrichemicals NZS 8409: 2004.
19.
The substance shall be applied using calibrated ground based spray equipment.
20.
Trials shall be conducted in a manner such as to prevent the substance entering surface
or ground water systems.
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the
trial in accordance with that proposed in the application and the approval controls.
1
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21.
The trials shall be conducted and managed so as to prevent vertebrates and non-target
invertebrates from coming into contact with the substance throughout the trials.
22.
Trial sites that are at risk of entry by grazing animals shall be secured by stock proof
fencing to exclude animals for the duration of the trial and any stock withholding
periods set by the ACVM Group of the New Zealand Food Safety Authority.
23.
At completion of the trials all treated fruit and/or plant matter shall be disposed of by;
24.
a.
burial or mulching in of the fruit/plant matter in a designated area within the
trial site; or
b.
depositing the fruit/plant matter in an approved landfill, subject to their
acceptance criteria. Note this waste shall not be used for composting.
A record shall be kept of the use of the substance. This record shall cover all matters
referred to in Regulation 6(1) of the Hazardous Substances (Classes 6, 8, and 9
Controls) Regulations 2001 and must be kept for not less than 3 years after the date on
which the substance that the record relates to is applied or discharged.
Emergency Management
25.
Any spillage of the substance shall:
a.
be contained and prevented from entering water bodies; and
b.
be absorbed with an appropriate absorbent material where appropriate. The
absorbent material shall be placed in sealed containers and disposed of
appropriately.
Disposal
26.
Any surplus substance remaining at the end of the trials shall be stored in an exempt
laboratory that meets the requirements set out in the Hazardous Substances (Exempt
Laboratories) Regulations 2001 for the purpose of further analysis or until disposed of.
27.
Where disposal of the substance is required it shall be disposed of in a manner
compliant with the Hazardous Substances (Disposal) Regulations 2001.
28.
Packaging no longer used to contain the substance or residue or rinsate from
equipment used to handle the substance shall be disposed of in a manner compliant
with the Hazardous Substances (Disposal) Regulations 2001.
Notification and inspection
29.
The Department of Labour [Attn. HSNO Project Manager (Workplace Group) or
equivalent position] and ERMA New Zealand shall be informed in writing (by letter,
fax or email) of the location, start, and completion of the trials. Notifications shall
include the following details:
Substance name
ERMA Application number
ERMA Approval number
SCAL–5016
HSC07013
HSC000
ERMA Applications Advisor
Brendon Noonan
ERMA New Zealand Decision: Application HSC07013
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30.
31.
If for any reason a breach of containment occurs, the Trial Director shall:
a.
notify the Department of Labour and ERMA New Zealand within 24 hours of
the breach being detected
b.
advise the relevant iwi authority, if the breach of containment results in the
contamination of a waterway.
The Authority, or its authorised agent, or properly authorised enforcement officers,
may inspect the facilities and trial sites at any reasonable time. Trial documentation, as
described in Control 4, notwithstanding its confidential nature, shall be available for
inspection by any enforcement officer, upon request.
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