ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
14 November 2007
Application Code
HSR07073
Application Type
To import or manufacture for release any hazardous
substance under section 28 of the Hazardous Substances
and New Organisms Act 1996 (“the Act”)
Applicant
Orion Crop Protection Limited
Date Application Received
14 June 2007
Submission Period
11 July 2007 – 22 August 2007
Consideration Date
14 November 2007
Considered by
A Committee of the Authority (“the Committee”)
Purpose of the Application
To approve for importation or manufacture OCP0703, a
herbicidal product containing an active ingredient
currently approved and in use in New Zealand and
overseas.
1 Summary of decision
1.1
The application to import or manufacture OCP0703 for release is approved
with controls in accordance with the relevant provisions of the Act, the HSNO
Regulations 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:
OCP0703
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 28. The decision was determined
in accordance with section 29, taking into account matters to be considered in
that section and additional matters specified under Part II 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 14 June 2007.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public
notification was made on 11 July 2007. Prior to public notification, the
processing of the application was stalled under section 52 while the Agency
sought further information.
3.3
Submissions closed on 22 August 2007.
3.4
Various Government departments, Crown Entities and interested parties,
including the New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines (ACVM) Group), the Ministry of Health and the
Department of Labour Work Place Group, which in the opinion of the Authority
would be likely to have an interest in the application, were notified of the receipt
of the application (sections 53(4) and 58(1)(c), and clauses 2(2)(e) and 5) and
provided with an opportunity to comment or make a public submission on the
application.
3.5
No comments or submissions were received.
3.6
The Agency was commissioned to prepare an Evaluation and Review Report
(the E&R Report) to aid the Committee in its decision making process. The
E&R Report consists of the Agency’s review of the application and available
data regarding the substance and/or its constituent components. In the E&R
Report, the Agency has proposed a suite of controls considered suitable to
manage the risks associated with the release of OCP0703 and has assessed the
potential risks the substance may pose to the environment, human health, Māori,
community and to the market economy.
3.7
Due to delays in completing this E&R Report, the Authority, with the
applicant’s consent, waived the requirement to consider this application 30
working days after the closing date for submissions for a further 29 working
days.
3.8
The Ministry of Health, the Department of Labour, the New Zealand Food
Safety Authority (Agricultural Compounds and Veterinary Medicines (ACVM)
Group), and the applicant were given the opportunity to comment on the E&R
Report and the controls proposed therein.
3.9
One response was received from the applicant, who did not raise any concerns
relating to the proposed controls.
3.10
No external experts were used in the consideration of this application
(clause 17).
3.11
The following members of the Authority considered the application (section
19(2)(b)): Professor George Clark, Ms Helen Atkins and Dr Kieran Elborough.
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3.12
The information available to the Committee comprised:
 the application; and
 the E&R Report including a confidential appendix.
4 Consideration
Purpose of the application
4.1
OCP0703 is a herbicide intended for use in the control of broadleaf weeds and
grasses in crops. The substance contains an active ingredient which is already
approved for this use in New Zealand. However, OCP0703 is formulated as a
water-dispersible granule while other substances containing the same active
ingredient are liquid formulations.
Sequence of the consideration
4.2
In accordance with clause 24, the approach to the consideration adopted by the
Committee was to:
 establish the hazard classifications for the substance and derive the default
controls that are prescribed under section 77 for each classification.
 identify potentially non-negligible risks, costs, and benefits.
 assess the potentially non-negligible risks and costs. Risks were assessed in
accordance with clause 12, and costs in accordance with clause 13. The
adequacy of the default controls, prescribed under section 77, was
considered alongside the assessment of risks and costs to determine whether
those controls should be varied and identify where additional controls need
to be applied, under section 77A, to mitigate any unacceptable risks.
 undertake a combined consideration of all the risks and costs and determine
whether the combined risks and costs are negligible or non-negligible.
 consider (a) whether any of the non-negligible risks could be reduced by
varying the controls in accordance with sections 77 or 77A, and (b) the costeffectiveness of the application of controls in accordance with clause 35 and
sections 77 and 77A.
 assess the benefits associated with this application in accordance with
clauses 9, 11, 13 and 14 and section 6(e).
 taking into account the risk characteristics established under clause 33,
evaluate the risks, costs and benefits in accordance with clause 34 and
section 29 and determine whether the application should be approved or
declined.
 confirm and set the controls.
Hazard classification
4.3
The Agency has classified OCP0703 as follows:
Hazardous Property
Classification
Skin irritancy
Eye irritancy
Aquatic ecotoxicity
Soil ecotoxicity
6.3B
6.4A
9.1A
9.2A
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Default controls
4.4
In the E&R Report, the Agency assigned default controls for OCP0703 based on
its hazardous properties as set out in the HSNO Regulations. The default
controls were used as a reference for evaluation of the application in the E&R
Report. The default controls are listed in Section 8 of the E&R Report and have
not been reproduced here.
Identification of the potentially non-negligible risks, costs and benefits
of the substance
4.5
In its evaluation of OCP0703, the Agency identified potentially significant, and
therefore non-negligible, risks, costs and benefits associated with the OCP0703.
Potentially non-negligible risks
4.6
The Agency considers that the potentially non-negligible risks associated with
OCP0703 relate to the substance’s properties as a skin and eye irritant (6.3B and
6.4A respectively) an aquatic ecotoxicant (9.1A) and a soil ecotoxicant (9.2A).
These risks arise during all phases of its lifecycle.
Potentially non-negligible costs
4.7
A “cost” is defined in Regulation 2 of the Methodology as “the value of a
particular adverse effect expressed in monetary or non-monetary terms”.
Accordingly, the costs were assessed in an integrated fashion together with the
risks in the Agency’s assessment.
Potentially non-negligible benefits
4.8
A “benefit” is defined in Regulation 2 of the Methodology as “the value of a
particular positive effect expressed in monetary or non-monetary terms”.
Benefits that may arise from any of the matters set out in clauses 9 and 11 were
considered in terms of clause 13.
4.9
The applicant has described the benefits associated with OCP0703 in their
application as follows:
4.9.1
The product will be an effective herbicide for target crop(s),
maximising crop yield and farming profitability.
4.9.2
The current formulation of the same ingredient is a liquid. A granule
offers additional benefits in terms of occupational exposure (splashing
into the eyes is not possible) and environmental (spillage will not run
off into streams etc).
4.9.3
The formulation has a considerably higher concentration in terms of the
active ingredient when compared to the current formulation of the same
active ingredient. This offers considerable environmental and cost
benefits in terms of reduction in resources required for packaging,
storage, transportation, etc.
4.9.4
The product will bring additional choice and competition to the market
place, providing economic benefits to the farming sector.
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4.10
The Agency accepted that the benefits of the availability of the substance are
potentially significant.
Assessment of the potentially non-negligible risks and costs of the
substance
4.11
Taking into account the Agency’s assessment of the potentially non-negligible
risks and costs associated with OCP0703 in New Zealand, the Committee
considers that:
 the human health risks associated with OCP0703 are negligible;
 the use of the OCP0703 poses non-negligible risks to non-target terrestrial
and aquatic plants growing on the borders of treated crops;

significant adverse impacts on the social or economic environment with the
controlled use of OCP0703 are not anticipated;

OCP0703 poses a low risk to Māori culture or traditional relationships with
ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other
taonga.
5 Controls
5.1
The applicant was given an opportunity to comment on the proposed controls as
set out in the E&R Report (clause 35(b)). The applicant did not raise any
concerns about the proposed controls.
Setting of exposure limits and application rates
5.2
Control T1 relates to the requirement to limit public exposure to toxic
substances by the setting of Tolerable Exposure Limits (TELs), which are
derived from Acceptable Daily Exposure (ADE) values. The Agency has noted
that in order for TELs to be set, the components of Regulation 11(1) must be
met. This control is triggered as a default control by the class 6 (irritancy)
hazards of the substance. As exposure to the substance is not likely to result in
an appreciable toxic effect (as required by Regulation 11(1)(c)) the Committee
has not set any TELs.
5.3
Control T2 relates to the requirement to limit worker exposure to toxic
substances by the setting of Workplace Exposure Standards (WESs). The
Agency has noted that no Department of Labour or HSNO WES values have
been set for any of the components of OCP0703. It is further noted that the
conditions of Regulation 29(1)(c) are not met as the Agency is not aware of
industrial hygiene data for OCP0703 that would enable a WES to be set for any
of the constituent components. Therefore, the Committee has not set WES
values for any components of OCP0703.
5.4
Control E1 relates to the requirements to limit exposure of non-target organisms
in the environment through the setting of Environmental Exposure Limits
(EELs). The Authority is intending to review the setting of EELs under section
77B. As this review has not been completed, no EELs are being set for
OCP0703 and the default values are deleted.
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5.5
Control E2 relates to the requirement to set an application rate for a class 9
substance that is to be sprayed on an area of land (or air or water) and for which
an EEL has been set. As no EEL has been proposed for OCP0703, the
Committee is not able to set an application rate under this regulation. However,
the Committee notes that the risk quotients derived from the environmental risk
modelling indicates that OCP0703 may cause adverse effects in the environment
if the substance moves off-target. The Committee is therefore setting a
maximum application rate control under section 77A.
Additional controls under section 77A
5.6
Under section 77A, the Authority may impose as controls any obligations and
restrictions that it thinks fit. Before imposing a control under this section, the
Authority must be satisfied that, against any other specified controls that apply
to the OCP0703:
(a) the proposed control is more effective in terms of its effect on the
management, use and risks of the substance; or
(b) the proposed control is more cost-effective in terms of its effect on the
management, use and risks of the substance; or
(c) the proposed control is more likely to achieve its purpose.
5.7
The Committee considers that controls relating to the setting of a maximum
application rate and prohibiting application of OCP0703 into or onto water will
be more effective than the specified (default) controls in terms of their effect on
the management, use and risks of the substance (section 77A(4)(a)).
Consequently, the following additional controls are applied to OCP0703 to
restrict the level of risk to the environment:
5.7.1
“OCP0703 may be applied once per year, at a rate of up to 0.0825 kg active
ingredient / ha.”
5.7.2
“OCP0703 shall not be applied onto or into water.”
Variation of controls under section 77
5.8
Under section 77(3), (4) and (5), the default controls determined by the
hazardous properties of OCP0703 may be varied.
5.9
The Committee has varied the following controls under section 77(4)(b) for
OCP0703, as the variations will not significantly increase the adverse effects of
the substance:
5.9.1
Controls E7 and AH1 relate to requirements for ecotoxic substances to
be under the control of an approved handler. The Committee considers
that these controls should be modified for OCP0703 so as to apply only
during use. Thus, the following control is substituted for Regulation
9(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls)
Regulations 2001:
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“(1). OCP0703 must be under the personal control of an approved
handler when the substance is (a) applied in a wide dispersive manner; or
(b) used by a commercial contractor.”
5.9.2
5.10
Control TR1 relates to the requirements for a substance to be tracked
and is triggered for OCP0703 only by virtue of its ecotoxicity. The
Committee considers that any risks that may arise during the
substance’s lifecycle are adequately managed by other controls such as
approved handler, packaging, labelling and emergency management
requirements. Thus, this control is deleted.
The Committee has combined the following controls under section 77(5) as they
relate to the same requirements:
5.10.1
Controls T4 and E6 which relate to requirements for equipment used to
handle hazardous substances.
5.10.2
Controls P13 and P15 which relate to requirements for packaging
hazardous substances.
5.10.3
Controls D4 and D5 which relate to requirements for disposal of the
substance.
6 Overall evaluation of risks and costs
6.1
On the basis of the risk assessment, and taking into account the controls
imposed, including the additional controls set under section 77A, the Committee
considers OCP0703 poses non-negligible risks to the environment and the
relationship of Māori to the environment.
Approach to risk
6.2
As the Committee considers that the risks to the environment are non-negligible
with the controls in place, clause 27 applies and the Committee must establish
their position on risk averseness and the appropriate level of caution that is to be
applied in this case. In particular, the Committee has given regard to the extent
to which the following risk characteristics exist as per clause 33:

Exposure to the risks is involuntary;

The risks may persist over time in the aquatic environment. However, the
available data (for fish and crustaceans) indicate that the chronic risks to
aquatic organisms are not high;

The risks are not subject to uncontrollable spread. Only those parts of the
environment exposed to OCP0703 will be potentially affected;

There is potential for irreversible effects to occur to aquatic plants and
non-target plants exposed to OCP0703;
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
The risks may not be known or understood by the general public;
however, this information is available. The HSNO controls require
identification of hazards and the means of avoiding and managing
adverse effects on the product label and in the supporting documentation.
In addition, the approved handler control will apply when the substance
is used in a wide dispersive manner or by a commercial contractor.
4.17
In considering the approach to risk, the Agency also notes that there are
substances which contain the same active ingredient(s) that are approved for use
in New Zealand. These substances are applied at a similar application rate as is
proposed for OCP0703. Accordingly, the Agency considers that approval of
OCP0703 will not present new risks to the environment.
4.18
However, given the high risk posed to non-target plants, based on the outcome
of the environmental risk assessment, the Committee considers that substances
containing the same active ingredient(s) as OCP0703 should be considered
potential candidates for reassessment.
Comparison of risks, cost and benefits
4.19
As the Committee considers that the risks to the environment are non-negligible
with the controls in place and that there are potentially non-negligible benefits
associated with the import or manufacture of OCP0703, the Committee is
satisfied that the benefits associated with the substance outweigh the risks and
costs.
7 Recommendations
7.1
The Committee recommends that, should inappropriate or accidental use,
transport or disposal of OCP0703 result in the contamination of waterways, the
appropriate authorities, including the relevant iwi authorities in the region,
should be notified. This action should include advising them of the
contamination and the measures taken in response.
8 Environmental user charges
8.1
The Committee considers that the application of controls to OCP0703 will
provide an effective means of managing risks associated with this substance. At
this time no consideration has been given to whether or not environmental
charges should be applied to this substance as an alternative or additional means
of achieving effective risk management.
9 Decision
9.1
The Committee determines that:
9.1.1
OCP0703 has the following hazard classifications:
Hazardous Property
Classifications
Skin irritancy
Eye irritancy
6.3B
6.4A
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Aquatic ecotoxicity
Soil ecotoxicity
9.1A
9.2A
9.1.2
Pursuant to section 29 and clause 27 the positive effects (benefits) of
the OCP0703 outweigh the adverse effects (risks and costs).
9.1.3
The application for importation or manufacture and release of the
hazardous substance, OCP0703, is thus approved with controls as
listed in Appendix 1.
9.2
In accordance with clause 36(2)(b), the Committee records that, in reaching this
conclusion, it has applied the balancing tests in section 29 and clause 27.
9.3
It has also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of OCP0703;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 14 – costs and benefits accruing to New Zealand
 clause 21 – the decision accords with the requirements and regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant
considerations;
 clause 24 – the use of recognised risk identification, assessment,
evaluation and management techniques;
 clause 25 – the evaluation of risks;
 clause 33 – risk characteristics;
 clause 34 – the aggregation and comparison of risks, costs and benefits;
and
 clause 35 – the costs and benefits of varying the default controls.
14 November 2007
George Clark
Chair
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSR07073
Date
HSR007874
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Appendix 1: Controls for OCP0703
Note: Please refer to the regulations for the requirements prescribed for each control and the
modifications listed as set out in section 5 of this document.
Table A1.1: Controls for OCP0703 – codes, regulations and variations.
Control
Code1
Regulation2
Topic
Variations
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
T1
11-27
Limiting exposure to toxic
substances
No ADE or TEL values are set for
OCP0703 at this time.
T2
29, 30
Controlling exposure in places of
work
T4/E6
7
Requirements for equipment used
to handle hazardous substances
T7
10
Restrictions on the carriage of
hazardous substances on passenger
service vehicles
E1
32-45
Limiting exposure to ecotoxic
substances
No EEL values are set at this time for
OCP0703 and the default EELs are
deleted.
E2
46-48
Restrictions on use within
application area
As no EEL has been set for
OCP0703, no application rate is
required to be set under this control.
However, the Agency considers it
appropriate that an application rate is
nonetheless set as an additional
control under Section 77A.
E5
5(2), 6
Requirements for keeping records
of use
E7
9
Approved handler requirements
Controls T4 and E6 are combined
Regulation 9(1) of the Hazardous
Substances (Classes 6, 8, and 9
Controls) Regulations 2001 is
replaced by:
“(1). OCP0703 must be under the
personal control of an
approved handler when the
substance is (a) applied in a wide
dispersive manner; or
(b) used by a commercial
contractor.
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
2 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions. The accompanying explanation is intended for guidance only.
1
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Control
Code1
Regulation2
Topic
Variations
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35,
36 (1)-(7)
General identification requirements
Regulation 6 – Identification duties
of suppliers
Regulation 7 – Identification duties
of persons in charge
Regulations 32 and 33 –
Accessibility of information
Regulations 34, 35, 36(1)-(7) –
Comprehensibility, Clarity and
Durability of information
I3
9
Priority identifiers for ecotoxic
substances
I9
18
Secondary identifiers for all
hazardous substances
I11
20
Secondary identifiers for ecotoxic
substances
I16
25
Secondary identifiers for toxic
substances
I19
29-31
Alternative information in certain
cases
Regulation 29 – Substances in
fixed bulk containers or bulk
transport containers
Regulation 30 – Substances in
multiple packaging
Regulation 31 – Alternative
information when substances are
imported
I21
37-39, 4750
Documentation required in places
of work
Regulation 37 – Documentation
duties of suppliers
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Control
Code1
Regulation2
Topic
Variations
Regulation 38 – Documentation
duties of persons in charge of
places of work
Regulation 39 – General content
requirements for documentation
Regulation 47 – Information not
included in approval
Regulation 48 – Location and
presentation requirements for
documentation
Regulation 49 – Documentation
requirements for vehicles
Regulation 50 – Documentation to
be supplied on request
I23
41
Specific documentation
requirements for ecotoxic
substances
I28
46
Specific documentation
requirements for toxic substances
I29
51-52
Duties of persons in charge of
places with respect to signage
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
Regulation 5 – Ability to retain
contents
Regulation 6 – Packaging markings
Regulation 7(1) – Requirements
when packing hazardous substance
Regulation 8 – Compatibility
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Control
Code1
Regulation2
Topic
Variations
Regulation 9A and 9B – Large
Packaging
P3
9
Packaging requirements for
substances packed in limited
quantities
P15
21
P13
19
Packaging requirements for
OCP0703
PG3
Schedule 3
The tests in Schedule 3 correlate to
the packaging requirements of UN
Packing Group III (UN PGIII).
PS4
Schedule 4
This schedule describes the
minimum packaging requirements
that must be complied with when a
substance is packaged in limited
quantities
Controls P13 and P15 are combined
Hazardous Substances (Disposal) Regulations 2001
D4
8
Disposal requirements for
OCP0703
D5
9
D6
10
Disposal requirements for packages
D7
11, 12
Disposal information requirements
D8
13, 14
Disposal documentation
requirements
Controls D4 and D5 are combined
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management
information: General requirements
EM6
8(e)
Information requirements for toxic
substances
EM7
8(f)
Information requirements for
ecotoxic substances
EM8
12-16, 1820
Level 2 emergency management
documentation requirements
EM11
25-34
Level 3 emergency management
requirements – emergency response
plans
EM13
42
Level 3 emergency management
requirements – signage
Hazardous Substances (Personnel Qualification) Regulations 2001
AH1
4-6
Approved Handler requirements
ERMA New Zealand Decision: Application HSR07073
Regulation 9(1) of the Hazardous
Substances (Classes 6, 8, and 9
Controls) Regulations 2001 is
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Control
Code1
Regulation2
Topic
Variations
replaced by:
“(1). OCP0703 must be under the
personal control of an
approved handler when the
substance is (a) applied in a wide
dispersive manner; or
(b) used by a commercial
contractor.
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
where applicable
The Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004 prescribe a number of controls relating to tank wagons
and transportable containers and must be complied with as relevant.
Section 77A Additional Controls
A maximum of one application of OCP0703 shall be made per year, at a rate of up to 0.0825 kg active
ingredient / ha.
OCP0703 shall not be applied onto or into water.
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