ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
26 February 2008
Application Code
HSC07047
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”)
Applicant
National Institute of Water and Atmospheric Research Ltd
(NIWA)
Purpose of the Application
To test compounds in experimental stream channels and
assess efficacy on Didymosphenia geminata (didymo) and
assess non-target impacts on stream biota and effects on the
environment (generic containment)
Date Application Received
31 January 2008
Consideration Date
26 February 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of decision
1.1
The application to import into containment hazardous substances described as
NIWA experimental compounds for aquatic trials, 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:
NIWA experimental compounds for aquatic trials for control of
Didymosphenia geminata
2
Application process
2.1
The application was formally received on 31st January 2008.
2.2
Project Team:
Elizabeth Morgan
Sue Scobie
Linda Faulkner
Beth Dye
Advisor (Hazardous Substances)
Senior Advisor (Hazardous Substances)
General Manager (Māori Unit)
Manager, Applications (Hazardous Substances)
2.3
The applicant supplied the following documents:
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2.4
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:
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3
the application,
a project plan for the first substance proposed for trials (Gemex),
a confidential appendix which includes formulation details of Gemex.
The Department of Conservation;
The Department of Labour (Workplace Group);
The New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
2.5
No responses were received.
2.6
The applicant was provided with a copy of the proposed controls for NIWA
experimental compounds for aquatic trials and given the opportunity to
comment on them. The applicant’s comments were taken into consideration in
finalising the controls.
Consideration
Purpose of the application
3.1
The purpose of this application is to import and/or manufacture substances for
experimental use in containment trials at the Monowai Experimental Facility
(MEF) which is located above the confluence of the Monowai and Waiau rivers,
beside the Monowai Power Station, as illustrated in the application. The field
trials are proposed to take place over a five year period. The purpose of the
field trials is to test the efficacy of various substances against Didymosphenia
geminata (didymo) and to assess the environmental effects and non-target
impacts of the substances on stream biota.
3.2
The applicant has indicated that their primary area of interest is in testing
chelated copper compounds. The first substance the applicant intends to trial is
Gemex, an algaecide containing chelated copper as the active ingredient.
Although the testing of Gemex is their principal interest at the present time, in
the future other copper-based substances (such as K-TEA as indicated in the
application) will be tested at the MEF. The applicant has undertaken other trial
work with Gemex (see HSC06032) and the proposed trials at the MEF are an
extension of that work.
3.3
The Project Team considers that the purpose stated by the applicant amounts to
“research and development on any hazardous substance” and therefore qualifies
for consideration under section 30(ba).
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Lifecycle
3.4
The applicant advises that the substances will be dealt with throughout their
lifecycles in New Zealand in the following manner:
Importation, manufacture and transport
3.4.1 The applicant is seeking approval to import and/or manufacture
substances for field trials in containment, and has given the lifecycle of
Gemex as an example of the type of substance they intend to test under
the provisions of the containment approval. The applicant intends to
manufacture Gemex in Hamilton and distribute the substance in containers
of 10 – 50 L capacity to NIWA researchers for product testing. The
applicant has indicated that up to 200 L of Gemex may be transported at
any one time. The Agency notes that in the future the applicant may
import substances for testing at the MEF, such as K-TEA (as indicated on
page 4 of the application form).
3.4.2 The Agency notes that the volume of substances imported/manufactured
may vary significantly from substance to substance. For example, the
applicant has indicated their intention to use up to 500 L of Gemex in two
trials at the MEF, while the volume of K-TEA required for trials in 2008
is not anticipated to exceed 3 L. Given the variation in volumes required
for testing, the Agency proposes that the maximum volume of substance
imported or manufactured under the provisions of this approval should not
be specified as a control; however, the applicant should notify the Agency
of the volume of substance imported/manufactured for use as part of their
trial protocol (refer to Appendix 2).
Storage & site security
3.4.3 The Agency notes that the substances will either be stored at the
manufacturing site or at the MEF. The MEF itself is surrounded by a 1.8
m high security fence with locked gates and is located on private land
behind the Monowai Power Station. Access is restricted via the power
station.
Application of the substances
3.4.4 Preparation and application of the trial substances will be carried out by
experienced trained staff. The applicant has indicated that the site
manager at the MEF is an Approved Handler and that all NIWA personnel
working at the facility are under the supervision of this individual.
3.4.5 The MEF itself is a streamside aquatic facility with 48 experimental
stream channels for research purposes. The MEF extracts a maximum
flow of 150 L/s from the penstocks of the power station and discharges
this volume directly into the tailrace of the power station. According to
the applicant, the flow through the power station is approximately 13,000
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L/s while the average flow of the Waiau River at Sunnyside (6.5 km
downstream from the Power Station) is 50,500 L/s.
3.4.6 The applicant has indicated that their intention is to test substances in a
manner that would result in dilution of any of the substances by at least
1000-fold in the tail race pool prior to entering the Waiau River, where the
discharge would be diluted further (approximately 3-fold). The Agency
considers that a control requiring minimum 1000-fold dilution of the trial
substances be set as part of this approval.
3.4.7 The applicant has described the application of Gemex as an example of
how substances tested at the MEF will be applied. Gemex will be held in
containers of 10 – 50 L capacity, designed for slow dispensing into the
channels. The substance will be applied to the experimental channel via a
precision pump set to achieve the desired treatment concentrations in each
channel for a defined period of time (depending on the study design).
After treating each channel Gemex would be diluted by discharge from
the remaining channels and then by dilution into the power station tail
race as described in Paragraph 3.4.6.
3.4.8 The applicant notes that in the event of an accidental release of the
substance being tested, extra water to dilute the spill can deliberately be
released from the header tanks which hold 3,000 L of water.
Disposal of surplus substance
3.4.9 The applicant has indicated that any quantity of substance remaining at the
end of each trial will be stored at a permanent storage facility. The
Agency considers that any HSNO approved substance that is used in the
trials must be stored/disposed of in a manner that is compliance with the
HSNO Regulations. Any substance that is not approved under HSNO and
is used in the trials must be stored in a lab which is exempt from the
requirements of the Act as set out in section 33.
4
Hazardous properties
4.1
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.
4.2
It is also noted that the scope of the hazard information will often be limited, as
the substances may be experimental and may not be commercialised. Each
substance imported or manufactured under this approval will be notified to
ERMA New Zealand prior to its trialling, and the notification will include
compositional information, a Project Plan and a Safety Data Sheet where
available and any available hazard information.
4.3
The applicant expects that the substances involved may have hazardous
properties that trigger the minimum degrees of hazard for each allowable hazard
category, as defined in the Hazardous Substances (Minimum Degrees of
Hazard) Regulations 2001 and as limited in Appendix 1.
4.4
After taking into account the substances’ potential hazardous properties, the
Project Team considers that the information provided is sufficient to determine
ERMA New Zealand Decision: Application HSC07047
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that any risks can be managed by the containment controls proposed in
Appendix 1.
Identification and evaluation of the significant risks of the substances in
containment
4.5
The applicant has identified and assessed potential risks and detailed proposals
for, and impacts of, risk management. The Agency 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
4.6
The Project Team considers that, if released or discharged into the environment,
the substances tested at the MEF have the potential to result in adverse effects
within the environment. As the ecotoxic hazards of all the substances which
may be tested at the facility under the provisions of this approval are not
identified at this stage, the Project Team assumes that the substances could
cause adverse effects within the aquatic, soil, or above-ground terrestrial
environments.
4.7
On the basis of the lifecycle of the substances outlined in paragraph 3.4, adverse
effects could arise from:
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an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances;
failure to follow correct disposal procedures as outlined in the
management plan.
4.8
The applicant has specified containment provisions intended to manage these
risks.
4.9
The Project Team considers that, taking into account the likely properties of the
substances, the quantities involved, the containment regime proposed by the
applicant, the controls set in Appendix 1 and in place under other legislation,
there are no significant risks to the environment.
Risks to human health
4.10
If the substances are ingested or inhaled, or come in contact with skin or eyes
they have the potential to cause adverse effects on human health.
4.11
On the basis of the lifecycle of the substances outlined in paragraph 3.4, adverse
effects could arise from:
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an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances;
failure to follow correct disposal procedures as outlined in the
management plan.
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4.12
Taking into account the properties of the substances, the quantities involved, the
containment regime proposed by the applicant, the containment controls in
Appendix 1 and controls in place under other legislation, the Project Team
considers there are no significant risks to human health and welfare.
Relationship of Māori to the Environment
5
4.13
Risks to the relationship of Māori to the environment were considered in
accordance with sections 6(d) and 8, and the assessment framework contained in
the ERMA New Zealand User Guide “Working with Māori under the HSNO
Act 1996”.
4.14
The Project Team notes that the applicant has consulted with the appropriate
iwi/Māori organisations about the containment proposal receiving support from
Te Ao Mārama Incorporated (TAMI). TAMI is a resource management
organisation that represents the interests of four papatipu rūnanga in the
Southland region.
4.15
Although the nature of the containment proposal adequately mitigates any
biophysical risk to non-target native and/or valued species, there is some
uncertainty about the potential risks to the mauri of those species and
ecosystems. However, the Project Team considers that the role of iwi/Māori as
kaitiaki is being preserved by the ongoing involvement by TAMI and local
marae occupants in the current and future trials (refer to controls relating to
Consultation, as given in Appendix 1).
4.16
From the information provided, and considering that the application is for
contained field trials, the Project Team considers that it is unlikely to have an
impact on the relationship between Māori culture and their 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 HSNO controls established for this application, and in accordance with any
other relevant controls applying under other legislation.
4.17
However, should inappropriate or accidental use, transport or disposal of the
substances result in the contamination of waterways, it is suggested that the
applicant notify the appropriate authorities including the relevant iwi authorities
in the region. This action should include advising them of the contamination
and the measures taken in response.
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:
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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;
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6
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.
Conclusion
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), namely research and development on any hazardous substance.
6.2
Having considered the risks associated with the lifecycle of, I am satisfied that
the controls imposed, including those in place under other legislation, will result
in the substances being adequately contained.
6.3
The application to manufacture or import into containment NIWA experimental
compounds for aquatic trials is thus approved with controls in accordance with
the relevant provisions of the Act and the Methodology as more specifically set
out in Appendix 3.
signed
Rob Forlong
Date: 26 February 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
HSC000317
NIWA experimental compounds for aquatic trials
for control of Didymosphenia geminata
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APPENDIX 1: LIST OF CONTROLS THAT APPLY
TO NIWA EXPERIMENTAL COMPOUNDS FOR
AQUATIC TRIALS
General requirements and restrictions
1.
This approval covers the contained importation, manufacture and trialling of
experimental compounds for aquatic trials at the site of the Monowai
Experimental Facility (MEF), as notified to ERMA New Zealand pursuant to
Control 6.
2.
This approval applies exclusively and is limited to substances being studied by
or on behalf of the National Institute of Water & Atmospheric Research Limited
(NIWA).
3.
No maximum total quantity of each experimental compound that may be
manufactured or imported has been set. The applicant shall include the volume
of substance to be imported or manufactured as part of their notification of
trials.
4.
This approval applies only to the aquatic application of experimental
compounds at the Monowai Experimental Facility (MEF). The containment
area extends from the site of the facility itself to the confluence of the Monowai
River with the Waiau River, as indicated by the applicant in their application
form.
5.
This approval remains in place for five years from the date of this decision.
6.
Each substance imported or manufactured under this approval shall be notified
in writing to ERMA New Zealand and the Department of Labour [Attn. HSNO
Project Manager (Workplace Group) or equivalent position] prior to its use in a
field trial. The notification shall include:
composition details;
a Project Plan for the trial, containing information as specified in
Appendix 2;
the volume of substance being imported or manufactured;
a Safety Data Sheet and/or any known hazard information; and
the following identifying details:
7.
ERMA Application number
HSC07047
Substance name/code
NIWA experimental compounds for aquatic trials
ERMA Approval number
HSC000317
ERMA Applications Advisor
Elizabeth Morgan
This approval does not apply to substances that trigger any hazardous property
thresholds in classes 1, 2, 3.2, 4 or 5.
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Packaging and information
8.
The substances shall be securely packed in suitable containers that comply with
the Hazardous Substances (Packaging) Regulations 2001.
9.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001.
10.
A Safety Data Sheet shall accompany any transported substances and be
provided to all individuals handling the substance.
Storage
11.
The substances shall be securely stored in accordance with good practice. This
may be demonstrated by compliance with the Code of Practice for the
Management of Agrichemicals NZS 8409:2004.
Transport
12.
The substances shall be transported in accordance with good practice and where
appropriate in compliance with any relevant requirements of the Land Transport
Act 1998, the Civil Aviation Act 1990 and the Maritime Transport Act 1994.
General handling of the substances
13.
Information on appropriate safety precautions necessary to provide safeguards
against the substances’ toxic and ecotoxic properties shall accompany the
substances at all stages of their lifecycles. Safety glasses, gloves and protective
clothing shall be worn when handling the substances throughout their lifecycles.
Trial site requirements
14.
The trials shall be carried out at the Monowai Experimental Facility.
15.
Access to the trial sites shall be by permission of the Trial Director1 or owner of
the property on which it is located. The trial sites shall be signed indicating that
unauthorised access is not allowed, that the site is subject to an experimental
pesticide trial.
16.
The trial sites shall be secured so as to prevent entry by animals or unauthorised
people.
1
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the
trial in accordance with the approval controls.
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Trial conditions
17.
The trials shall be undertaken in accordance with the information provided in
the application and the Project Plan which accompanies the notification of each
substance. Modifications to the Project Plan or information provided in the
application may only be made with the prior written approval of ERMA New
Zealand and must be in compliance with the controls specified in this document.
18.
The personnel applying the substances shall be able to demonstrate that they
have the qualifications necessary to carry out the trial. They should also be
aware of the contents and requirements of the Trial Management Plans and
these controls in order to adequately manage the substances.
19.
The substances shall be mixed, diluted and prepared prior to application in
accordance with good practice. This may be demonstrated by compliance with
a Standard Operating Procedure retained as part of the applicant’s trial records.
20.
Only the quantity of each substance that is sufficient for the trial work in the
study shall be taken to the study site.
21.
The substances shall be applied by way of equipment calibrated to apply
accurate doses to the experimental stream channels. This would generally be
achieved through compliance with a Standard Operating Procedure retained as
part of the applicant’s trial records.
22.
The application of the experimental compounds shall be managed so that
discharge rates in the Waiau River do not exceed the Australian & New Zealand
Environment and Conservation Council (NZECC, 2000) water quality
guidelines for the substance being testing. Alternatively, where no guideline
value has been set for a test substance, the application of the experimental
compounds shall be managed so that there is a minimum 1000-fold dilution of
the discharge into the Waiau River.
23.
A record shall be kept of all use of the substances. 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.
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Emergency management
24.
Any spillage of a substance onto a hard surface or land shall be contained,
prevented from entering water bodies, and be absorbed with an appropriate
absorbent material. The absorbent material shall be collected and placed in
sealed containers for disposal at an appropriate waste disposal facility (which
may include a landfill), subject to the facility’s waste acceptance policy.
25.
Should any substance be spilled into a body of water, the substance must be
diluted so that there is a minimum 1000-fold dilution of the discharge.
Disposal
26.
The amount of substance prepared shall be the minimum necessary for the trial.
In cases where the trial substances are specifically imported or manufactured for
the trials, i.e. the substance does not have HSNO approval to be released in New
Zealand, any surplus substance remaining at the end of a trial2 shall be stored
securely by NIWA in a laboratory complying with the requirements set out in
the Hazardous Substances (Exempt Laboratories) Regulations 2001 for the
purpose of further analysis or until disposed of. Note that once the trials are
completed, any substance that does not have HSNO approval will not have
approval to be present in New Zealand except within an exempt laboratory.
27.
Any surplus substance shall ultimately be treated in a manner to render the
substance, as a whole, non-hazardous or be exported from New Zealand.
Disposal shall be carried out in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001.
28.
Containers no longer used to contain the substance shall be disposed of in a
manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
29.
Any equipment used shall be triple rinsed after use with water and if required
with an appropriate detergent or decontaminant, and the rinsate disposed of as
hazardous waste, or otherwise rendered non-hazardous.
Consultation
30.
Prior to each trial operation the Trial Director shall consult with Te Ao Mārama
Incorporated and other relevant Māori stakeholders.
31.
Reports shall also be provided to Te Ao Mārama Incorporated and other
relevant Māori stakeholders at the completion of trial operations outlining the
results of the trials and any issues arising.
2
The end of the trial is considered to be the end of the trial programme as defined in the project plan for each
substance.
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Notification and inspection
32.
If for any reason a breach of containment occurs, the Trial Director shall notify
the Department of Labour and ERMA New Zealand within 24 hours of the
breach being detected. If a breach in containment results in significant
contamination of a waterbody, the relevant iwi authorities shall be advised.
33.
Trial documentation, as described in Control 6, notwithstanding its confidential
nature, shall be available for inspection by any enforcement officer, upon
request.
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APPENDIX 2: CONTENTS OF PROJECT PLAN
The Project Plan to be supplied for each substance shall contain information on the following
points:
1) Direction, including identification and contact details of the Study Director
2) Identification of the substance, including the formulation/composition of the substance
3) Project title
4) Objectives
5) Number of experimental channels to be treated
6) Application method
7) Application rate, frequency and duration
8) Discharge rates from the Monowai Experimental Facility
9) Volume of substance imported or manufactured for the trial
10) SDS and hazard data for the substance, where available
11) A copy of the substance label
12) Where the substance is manufactured in New Zealand specifically for the trials (i.e. the
substance does not have a HSNO approval) details of the site and location of the
manufacture and containment system at the manufacturing site.
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APPENDIX 3: LEGISLATIVE CRITERIA FOR THE
APPROVAL
A2.1.
Unless otherwise stated, references to section numbers in this decision refer to
sections of the Act and references to clauses refer to clauses in the
Methodology.
A2.2.
The application was lodged pursuant to section 31. The decision was made 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
(including the Methodology) and the provisions of Part III of the Third Schedule
of the Act.
A2.3.
Government departments with an interest in this type of application were
advised of the receipt of the application in accordance with clause 2(2)(e).
A2.4.
This application was considered by the Chief Executive of ERMA New Zealand
under delegation from the Authority (section 19(2)(e)).
A2.5.
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 (Clauses 9, 12, 13, 14,
22, 24, 25) 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.
A2.6.
In accordance with clause 36(2)(b), it is recorded that, in reaching his decision,
the Chief Executive applied the criteria specified in section 32.
A2.7.
The Chief Executive also applied the following criteria in the Methodology:

clause 11 – characteristics of substance;

clause 21 – the decision accords with the requirements of the Act and
regulations;

clause 26 – all risks negligible;

clause 35 – the costs and benefits of the controls.
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