ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
21 December 2006
Application Code
HSE06003
Application Type
To manufacture and use a hazardous substance in a special
emergency under Section 49D of the Hazardous Substances and
New Organisms Act 1996 (the Act)
Applicant
Ministry of Agriculture and Forestry, Biosecurity New Zealand
(the applicant)
Purpose of the Application
To manufacture and use the chelated copper formulation
Gemex, to control or eradicate the pest algae Didymosphenia
geminata in waterways in the North Island of New Zealand, or
in significant new incursions in the South Island of New
Zealand.
Date Application Received
13 December 2006
Consideration Date
19 December 2006
Considered by
Hearings Committee of the Authority
1
Summary of decision
1.1
The application to manufacture and use Gemex in a special emergency declared under
section 49B 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 identifiers for the ERMA New
Zealand Hazardous Substances Register:
Gemex TM 2% (special emergency)
Gemex TM 3% (special emergency)
1.3
2
The substances GemexTM 2% and GemexTM 3% are subsequently referred to within
this document as Gemex.
Legislative criteria for the application
2.1
This approval is sought in advance of a special emergency being declared. The
substance may only be used only if the Minister for Biosecurity declares a special
emergency pursuant to Section 49B.
2.2
The applicant advises that a special emergency would need to be declared by the
Minister for Biosecurity if an incursion of Didymosphenia Geminata (D. Geminata,
didymo) occurs in the North Island of New Zealand, or a significant new incursion
occurs in the South Island. The applicant considers that the special emergency would
be likely to be declared [in the event of an incursion] during the risk period of summer
2006/2007 when the general public are using waterways in large numbers and are more
likely to observe infestations. The applicant also advises that surveillance for didymo
will also be more frequent during this period.
2.3
On 13 December 2006, the applicant lodged an application pursuant to section 49D to
manufacture and use Gemex in the special emergency. The decision was determined in
accordance with section 49F taking into account additional matters to be considered in
that section, the matters specified in Part II of the Act (Purpose of Act) and the
relevant provisions of the Methodology. Unless otherwise stated, references to section
numbers in this decision refer to sections of the Act and clauses to clauses of the
Methodology.
2.4
In accordance with section 49F, the approach adopted when considering this
application was to consider all the information having regard to the particular
circumstances of the special emergency that the applicant provided under section 49E
and determine whether:
 the hazardous substance is necessary for use in the special emergency; and
 the proposed plan adequately controls the adverse effects of the substance.
3
Application process
3.1
The application was formally received on 13 December 2006.
3.2
Project Team:
Bella Whittle
Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Robinson
General Manager (Maori Unit)
3.3
The applicant supplied the following documents:
 the application;
 The Proposed Management Plan for the manufacture and use of GemexTM on the
unwanted alga Didymosphenia geminata in a special emergency (subsequently referred
to as the Management Plan); and
 Confidential appendices including:
 formulation details,
 supporting information,
 a letter of support for south island trials from Te Ao Marama Inc.
 the Gemex TM Treatment Contingency Plan for Didymosphenia geminata,
 information on the manufacturer and supplier of Gemex, and
 other supporting references containing information on the substance the
didymo incursion.
3.4
Pursuant to sections 49F(2)(a) and 49F(2)(b), the Authority consulted the Department
of Conservation (DoC), and other interested government departments on the
application.
3.5
The comments provided by DoC were in support of approval of the application to
manufacture and use Gemex to attempt to control or eradicate the pest alga D.
geminata. However, two concerns were raised. First, that Gemex may not completely
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eradicate the alga, and second, that the substance may adversely impact non-target
species.
3.6
In accordance with section 49F(2)(a), the Committee had particular regard to the views
of the DoC in the consideration of this application.
3.7
The Ministry of Health (MoH) commented on the Maximum Acceptable Value (MAV)
of compounds present in the water downstream of the treatment site. MoH suggests
that no applications be made upstream of water supply intakes unless:
 owners of water supply intakes are advised when (and for how long) copper
exceeding 2 mg/L will pass their intake, and
 the water supplier can arrange to close the intake while the water with more
than 2 mg/L of copper content passes, or
 flow from a tributary, or uptake, or deposition has reduced the copper content
to less than 2 mg/L.
3.8
The Committee had regard to, and considered, these views in its consideration of the
application. The Committee notes that the Management Plan states that water
supplies (for irrigation drinking and stock watering) within the treatment area will be
identified and arrangements made with the landowners/occupiers to cease water
abstraction on the day of treatment.
3.9
The Agricultural Compounds and Veterinary Medicines Group (ACVM) of the New
Zealand Food Safety Authority (NZFSA) commented that products used to control
plants in waterways which are not used for aquaculture have not been considered as
Agricultural Compounds. However, the ACVM noted that sheep, and some particular
breeds, are considered more sensitive to copper. A recommendation was made that the
applicant should ensure there are no stock water supplies being taken off for
reticulated water systems (e.g. being piped to troughs, water tanks etc or supplying
stock water races).
3.10
The Committee considered the comments supplied by the ACVM and notes the
provision in the Management Plan for the cessation of water abstraction on the day of
the treatment, which addresses the concern raised by ACVM.
4
Consideration
Sequence of the consideration
4.1
This application was considered by the following members of the Authority’s Hearings
Committee (acting under a delegation under section 19(2)(b)): Mr Tony Haggerty
(Chair), Professor George Clark, Mr Max Suckling on 19 December 2006.
4.2
In accordance with section 49F and clause 24, the approach adopted when
determining the application was to:


consider whether the applicant had provided sufficient information to determine
whether the substance should be used in a special emergency;
consider the purpose of the application and determine whether the substance is
necessary for use in the special emergency;
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

consider the lifecycle of the substance and determine the hazardous properties
and adverse effects of the substance; and
consider whether the Management Plan provided by the applicant adequately
controls the adverse effects of the substance.
Information review
4.3
The Committee has reviewed the applicant’s information and additional information
available to it and considers that there is sufficient information to determine whether
Gemex should be manufactured and used in the special emergency.
Purpose of the application
4.4
The purpose of the application is to obtain approval under the Act to manufacture and
use the chelated copper formulation Gemex, in an attempt to eradicate didymo, should
it be detected in waterways of the North Island of New Zealand or in significant new
incursion sites in the South Island of New Zealand, and for which the Minister of
Biosecurity declares a Special Emergency under section 49.
4.5
As the purpose amounts to the manufacture of a hazardous substance; and the use of a
hazardous substance in a manner that would contravene the Act, the Committee
considers that the application qualifies for consideration under sections and 49D(2)(b)
and 49D(2)(d). The Agency notes that, while sections 49A to 49K refer to agricultural
compounds and veterinary medicines, under 49L(1) sections 49A to 49K apply to the
rapid assessment of other hazardous substances in special emergencies.
Criteria for declining the application
4.6
Under section 49F(3) the Authority may decline the application only if it is satisfied
that –
(a) the hazardous substance is not necessary for use in the special emergency; or
(b) the proposed plan does not adequately control the adverse effects of the
hazardous substance.
The necessity to use the hazardous substances to deal with the special emergency.
4.7
The applicant considers that the substance is necessary to control didymo, and states
that studies commissioned by Biosecurity New Zealand establish that the uncontrolled
spread of the alga will have significant negative environmental, economic and cultural
effects through the degradation of the abundance and diversity of species in freshwater
rivers in New Zealand. The applicant considers that an attempt to eradicate didymo
before the alga becomes established in ‘mats’ is essential, as it may become more
difficult to control.
4.8
NIWA, on contract to the applicant, has undertaken a research programme to identify
compounds and methods to control didymo. A range of alternative compounds have
been tested. They consider that Gemex is the most effective biocide against didymo
with the least toxicity to non-target species.
4.9
The Committee considers that the eradication of didymo using the most effective
compound would be beneficial to the environment. Further, the Committee has
considered the applicant’s view that the risk period for the substance being detected
would be summer 2006/2007. Before this period, there will be insufficient time for
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the applicant to make a publicly notified application. The Committee considers that
the substance is necessary for use, should a special emergency be declared by the
Minister of Biosecurity under section 49.
Controlling the adverse effects of the substance
Hazardous properties
4.10
The applicant has estimated the hazard classification of Gemex, based on data on
copper sulphate anhydrous. This reference substance is regarded to be more toxic
than Gemex. The Agency has not undertaken a full hazard classification of the
substance, but based on the concentration of the chelated copper present within
Gemex and the pH of the formulated product, considers the substance to trigger the
following classifications:



8.3A Eye Corrosiveness
8.2C Skin Corrosiveness
9.1A Aquatic Ecotoxicity.
Lifecycle
4.11
In assessing the adverse effects of the substance, the Agency reviewed the lifecycle of
the substance as described in the applicant’s Management Plan. The substance will be
manufactured, stored, transported, used, and disposed of in accordance with this plan.
Risks identified throughout the lifecycle of the substance are identified with
consideration to the environment and to human health.
Proposed management plan for dealing with the hazardous substance in a special
emergency
4.12
Under section 49G, a management plan must be provided by the applicant. It must
include coverage of the measures that can be taken to avoid, remedy or mitigate any
actual or potential adverse effects of the substance and the requirements for the
disposal of the substance. The plan is provided as Appendix 1, and summarised
below.
4.13
The applicant intends to manufacture and stockpile approximately 5000 L of Gemex in
preparation for an urgent treatment of didymo under the direction of Biosecurity New
Zealand. If a special emergency is declared, the applicant intends that Gemex could be
transported almost anywhere within the North Island within 2 days. The Committee
considers that the substance may not be manufactured without a special emergency
first being declared. However, any Gemex manufactured under a separate approval,
(for manufacture in containment), if available, may be used in accordance with section
49D(2)(d).
4.14
The applicant includes provisions for packaging, identification, transportation, and
storage will be undertaken in accordance with the Management Plan, in regard to the
relevant HSNO Regulations.
4.15
The applicant advises that prior to treatment, the personnel, equipment, and Gemex
will be transported to the treatment site using trucks, boats or helicopters. There may
be a requirement to redistribute some substance to larger tanks for distribution by the
pumping equipment. A sub-surface diffuser would be placed across the width of the
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waterway at the treatment location. The maximum target application rate would be 20
mg Cu/L in receiving water.
4.16
The applicant also intends to conduct hand-spraying of isolated, interconnected
backwaters and moist fragments. Gemex used for hand-spraying would be diluted to a
maximum of 20 mg Cu/L before spraying.
4.17
Multiple strategic follow up treatments by application to flowing water and hand
spraying may be required. The applicant advises that between 3 and 10 follow up
treatments spaced 24 hours apart may be more effective than a single treatment.
4.18
The Management Plan includes provisions for dealing with an accidental release of the
substance, and means of decontamination of equipment. Further, the Gemex
Treatment Coordinator shall ensure there are no unacceptable soil residues should a
spillage occur.
4.19
The applicant advises that any unused product will be transported back to the chemical
storage facilities and may be stored long-term. Any packages remaining at the
completion of treatment shall be disposed of through local landfills, subject to the
facility’s waste acceptance policy, or treated so they are no longer hazardous.
4.20
The Management Plan provides that records shall be kept of the use of the substance,
that ERMA New Zealand shall be notified of the location of the treatment sites prior
to application of Gemex.
Identification and evaluation of the adverse effects of the substance for use in the
special emergency
4.21
In the application, the applicant identified and assessed potential adverse effects, and
detailed proposals for, and impacts of risk management. The Committee has reviewed
the applicant’s assessment of adverse effects and agrees that that it is suitable for the
consideration.
Adverse effects to the environment
4.22
The applicant and Agency have identified that environmental exposure and subsequent
adverse effects to the environment may arise during use of Gemex:
 spillage of Gemex during manufacture;
 spillage of Gemex in transit;
 leakage or spillage of Gemex during storage;
 exposure to non-target species during use;
 chelated copper accumulation in the environment;
 exposure caused by disposal of unwanted surplus or containers;
 contamination caused by equipment with residues attached.
4.23
The application and the Management Plan contain measures that must be taken to
avoid, remedy or mitigate the adverse effects arising from the manufacture and use of
Gemex. The Committee has reviewed these proposals and is satisfied that they are
adequate to control the adverse effects of the substance to the environment, with the
following conditions:
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

in light of the potential risk to non-target organisms, or accumulation of the
substance in the environment; the Committee requires the applicant to report the
results of any monitoring to ERMA New Zealand.
to clarify the concentration of Gemex being applied to the waterway, the
Committee determines that the applicant make an amendment to state on the
product label the target concentration required (for flowing water); and the
dilution rate (for hand spraying).
Adverse effects on human health and welfare
4.24
The Agency considers that adverse health effects may occur as a result of the corrosive
properties of Gemex. The applicant has identified that adverse effects to the human
health and welfare may arise from the concentrated product, or while diluted in river
water. The risks identified by the agency and applicant are provided below:









spillage, of product resulting in worker or public exposure to concentrated Gemex
during manufacture or packaging;
occupational exposure to concentrated Gemex during manufacture or packaging
(for example, product being transferred from protective clothing to eyes);
spillage or breach of packaging occurring during storage resulting in worker or
public exposure;
spillage or breach of packaging, or accident occurring during transit, resulting in
public or worker exposure;
worker or bystander exposure to concentrated Gemex dispensing from the
container to the application equipment;
worker or bystander exposure to concentrated Gemex while hand-spraying on
areas of the river-bed;
worker or public exposure to diluted Gemex during or after a river treatment (or
from repeated river treatments);
Gemex entering a water-supply, resulting in contamination and public exposure;
worker or public exposure to equipment with Gemex residues attached.
4.25
The application and the Management Plan contain measures that must be taken to
avoid, remedy or mitigate the adverse effects arising from the manufacture and use of
Gemex.
4.26
The Committee has reviewed these proposals and is satisfied that they are adequate to
control the adverse effects of the substance to human health and welfare.
Māori issues and concerns
4.27
Kaupapa Kura Taiao has considered this application and notes that the use of a
substance of this kind would normally require national consultation because of the
potential adverse effects to aquatic taonga species, the mauri of waterways and native
ecosystems, and the role of iwi/Maori as kaitiaki. However, the need to seek approval
to use this substance in a special emergency prior to the high risk summer season
makes undertaking national consultation prohibitive.
4.28
Kaupapa Kura Taiao also notes that the applicant has conducted extensive
consultation with four papatipu runanga in Southland regarding an application to trial
this substance in the Princhester Creek and Monowai River receiving enthusiastic
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support. These runanga consider that any potential adverse effects are adequately
minimised by the management regime proposed and note also that the extremely
invasive nature of D.geminata poses greater risk to taonga species, native ecosystems,
and culturally important mahinga kai (traditional food gathering sites).
4.29
Having regarded the nature of the special emergency application, the measures taken
to address Māori issues and interests, and the controls applied as part of this decision,
Kaupapa Kura Taiao considers any likely impact of this substances on Māori culture or
traditional relationships with their ancestral lands, water, sites, wāhi tapu, valued flora
and fauna or other taonga to be short term and minimal. In addition there is no
evidence to suggest that the controlled and notified use of the substances will breach
the principles of the Treaty of Waitangi.
4.30
However, Kaupapa Kura Taiao has discussed with Biosecurity New Zealand the need
to distribute notification to iwi/hapu groups (utilising ERMA New Zealand’s database)
about the approval, and explaining the circumstances under which it would be used.
This notification will also provide iwi/hapu groups with a point of contact should they
wish to discuss or receive further information about the substance and its use in the
eradication/management of D.geminata. This requirement is to be added to the Gemex
Treatment Contingency Plan.
4.31
In addition Kaupapa Kura Taiao considers that the relevant iwi/hapu groups be
advised of any accidental unanticipated use or impact, resulting from the use of
Gemex. This action should include advising the relevant group/s of the measures
taken to contain and remediate.
Economic and related effects of the use of the substance
4.32
The applicant advises didymo would have a significant economic impact on recreation
values, extinction of native species, reduced tourism expenditure, increased costs for
water intakes, impacts on commercial eel fisheries, and potential disruption to drinking
water. Government intervention to delay the introduction of didymo into the North
Island may decrease the costs expected to these areas. However, the applicant did not
comment on the projected cost of treatment, or on the economic costs posed by the
use of the substance.
4.33
The Committee considers that the economic impact of the uncontrolled spread of
didymo is thus significant. The Committee has not viewed an analysis of the cost of
using Gemex; however, it notes that some economic risks may arise from the use of
the substance, for example potential impacts on tourism, fisheries, and disruption to
drinking water supplies may be evident. In addition, the Committee considers that in a
worst-case scenario that several helicopter journeys to the treatment site may be
necessary, which would occur at a significant cost. However, the Committee considers
the economic impacts to be short term and temporary, most likely for the day/s of
treatment only. The Committee also considers the risk of didymo is likely to pose a
greater long-term economic risk. Thus, the Committee is satisfied that the proposed
use of the substance has benefits that outweigh any adverse effects on New Zealand’s
market economy.
Social, cultural, ethical or spiritual effects
4.34
The applicant notes that if the spread of didymo continues, social impacts may occur.
These could be related to reduced recreation values, extinction of native species,
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reduced tourism expenditure, increased costs for water intakes, impacts of commercial
eel fisheries, and potential disruption to drinking water. The applicant considers that
the use of Gemex to control the alga is unlikely to have significant effects on social,
cultural, ethical or spiritual values, noting that access to the waterway will be limited
for the day of treatment, and subsequently normal use of the waterway could resume.
4.35
The Committee considers that the use of the substance may have temporary effects on
social, cultural, ethical or spiritual values. However, it notes that these effects will be
temporary, and the continued presence of didymo would present greater disruption.
Thus, the Committee is satisfied that the proposed use of the substance has benefits
that outweigh any adverse effects on social, cultural, ethical or spiritual values.
Effects related to New Zealand’s international obligations
4.36
The applicant notes that no formal international obligations relating to the use of
Gemex to control D. geminate could be identified. However, the applicant considers
that there may be international interest in successful control techniques, given that
nuisance growths of didymo are establishing in their natural range (Northern Europe).
4.37
The Committee is satisfied that the proposed use of the substance will not have
adverse effects on New Zealand’s international obligations.
5
Controls
5.1
6
The Committee has evaluated the adequacy of the arrangements proposed by the
applicant in the Management Plan (refer Appendix 1) and consider that these are
adequate to control the adverse effects of Gemex, with specific amendments. These
amendments relate to:
 the provision for the reporting of the results of monitoring to ERMA New
Zealand; and
 the applicant stating on the product label the target concentration required (for
flowing water); and the dilution rate (for hand spraying).
Recommendation
6.1
The Committee notes that Kaupapa Kura Taiao has discussed with Biosecurity New
Zealand the need to distribute notification to iwi/hapu groups (utilising ERMA New
Zealand’s database) about the approval, and explaining the circumstances under which
it would be used. The Committee recommends that this requirement is to be added to
the Gemex Treatment Contingency Plan.
6.2
In addition, the Committee recommends that the relevant iwi/hapu groups be advised
of any accidental unanticipated use or impact, resulting from the use of Gemex. This
action should include advising the relevant group/s of the measures taken to contain
and remediate.
7
Decision
7.1
The Committee has considered this application made under section 49D, and pursuant
to section 49F, the Committee is satisfied that the substance is necessary for use in the
special emergency.
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7.2
Having considered the risks associated with the lifecycle of Gemex, the Committee is
satisfied that the Management Plan and the controls imposed, including those in place
under other legislation, will result in the substance being adequately managed in
accordance with the Act.
7.3
The Committee has also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 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.
7.4
The application manufacture and use Gemex in a special emergency is thus approved
pursuant to section 49F, with the following controls:
7.4.1
The substance may only be used if managed in accordance with the
Management Plan provided by the applicant.
7.4.2
The applicant shall report the results of any monitoring to ERMA New
Zealand.
7.4.3
The applicant shall state on the product label the target concentration
required (for flowing water); and the dilution rate (for hand spraying).
7.4.4
The approval takes effect on the date of this decision. The date of expiry of
this approval shall be the earlier of:
 the date of the expiry (if any) of the special emergency declared by the
Minister for Biosecurity in the declaration declaring the special
emergency, or in a later declaration declaring that the special emergency
has ceased; or
 2 years after the date of this decision.
7.4.5
On expiry of this approval the Gemex must be disposed of or stored in an
exempt laboratory (under the HSNO (Exempt Laboratories) Regulations
2001), unless, before the expiry of the approval, the applicant has, under any
other provision of the Act, been granted an approval.
21 December 2006
Tony Haggerty
Date
Chair
ERMA New Zealand Decision: Application HSE06003
Approval Codes:
Gemex TM 2% (special
emergency): HSE000007
Gemex TM 3% (special
emergency) HSE000008
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Appendix 1: The Proposed Management Plan for the manufacture
and use of GemexTM on the unwanted alga Didymosphenia
geminata in a special emergency (the Management Plan)
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