decision - Environmental Protection Authority

decision - Environmental Protection Authority

DECISION
18 October 2013
1. Summary
Substance
KASUMIN
Application code
APP201581
Application type
To import or manufacture any hazardous substance under Section 28 of the
Hazardous Substances and New Organisms Act 1996 (“the Act”)
Application sub-type
Notified - Category C
Applicant
ETEC Crop Solutions Limited
Purpose of the application
To import KASUMIN bactericide antibiotic containing kasugamycin for the
control of Pseudomonas syringae pv. actinidiae (Psa-V) in kiwifruit
Date application received
28 May 2013
Submission period
12 June 2013 – 24 July 2013
Submissions received
Four submissions were received.
Submitter position
Number of
submissions
Supported approval
1
Opposed approval
1
Did not indicate support or
opposition to approval
2
Consideration date
9 October 2013
Considered by
A decision-making Committee of the Environmental Protection Authority (“the
Committee”):
Louise Malone (Chair)
Kevin Thompson
Kerry Laing
Decision
Approved with controls
Approval code
HSR100889
Hazard classifications
6.1E, 6.8B, 6.9B
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2. Application process
Background
2.1.
KASUMIN is a bactericidal pesticide containing 20 g/L of kasugamycin in the form of a water
soluble concentrate. KASUMIN is intended for use in the control of Pseudomonas syringe pv.
actinidiae (Psa-V) in kiwifruit.
2.2.
The applicant has described the lifecycle of the substance as follows.
Importation, transport and storage
2.3.
KASUMIN is a water soluble concentrate manufactured in Japan, where it is packed and stored
in 180 litre drums. It will be repacked into labelled polyethylene (PE) containers of between 1
and 20 litres for retail distribution as marketable packs. Transport to New Zealand will be via
sea or air. KASUMIN will be imported into New Zealand by the sole New Zealand agent, fully
formulated and packaged and transported to a designated depot for storage of chemical
products for eventual delivery to dealers and retail distributor premises. Storage will be in an
Auckland warehouse contracted for this service. Transport throughout New Zealand of bulk
cartons containing multiple packs will be by licensed road carriers, whilst transport in public
passenger vehicles is not envisaged.
Use
2.4.
KASUMIN is to be used specifically to aid in the control of the bacterial disease Psa-V in
kiwifruit. Application is made by dilution in water and applied as a high-volume ground-based
spray to the vine foliage and stems. Applicator equipment would include calibrated commercial
orchard sprayers.
Disposal
2.5.
The plastic container will be retained until emptied of the liquid contents. Any residual substance
will be diluted with water and disposed of onto waste barren ground or added to the rinsate in
the spray tank. The empty container will not be refilled, reused or burnt but can be disposed of
by recycling in an appropriate program (e.g. AgRecovery). The empty container will be triple
rinsed and rinsate added to the spray tank. An alternate disposal method of the empty container
is according to the local council by-laws for industrial waste or burial in a suitable landfill.
Formal receipt and notification
2.6.
The application was lodged pursuant to section 28 of the Act.
2.7.
The Labour Group of the Ministry of Business, Innovation and Employment (MBIE), the
Agricultural Compounds and Veterinary Medicines (ACVM) Group of the Ministry of Primary
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Industries, the Ministry of Health and the Department of Conservation (DOC) were advised of
the application. No comments were received.
2.8.
The application was publicly notified as it was considered that there was likely to be significant
public interest in the application because it contains an active ingredient which has not
previously been approved in New Zealand. It was also considered that there might be significant
interest in KASUMIN because of its intended use.
Submissions
2.9.
Four submissions were received. One opposed the application, one supported it, and two did
not indicate opposition or support, but had concerns about some parts of the application.
2.10. The main concerns identified by submitters were around the risk that antibiotic residues pose to
the bee-product export market. The staff considered this was an adverse effect better
considered during ACVM registration, as it related to the safety of exported food and foodrelated products which is covered under the Animal Products Act (1999). The Ministry for
Primary Industries (MPI) is also tasked with considering risks to trade under the Agricultural
Compounds and Veterinary Medicines (ACVM) Act (1997).
2.11. Concerns were also raised by submitters about the lack of proven benefits of the substance. It
is difficult to accurately estimate the magnitude of a benefit prior to distribution through the
marketplace, and so the staff assessment carefully considered the likelihood of a benefit arising.
This was in part due to the fact that evidence of efficacy testing is usually submitted as part of
an ACVM registration, but not with a HSNO application. The staff advised the Committee that it
is highly likely that some magnitude of benefit will be realised through the use of this substance.
The staff also noted the submission from David Tanner (on behalf of Zespri, Kiwifruit Vine
Health and New Zealand Kiwifruit Growers Incorporated) which demonstrates that the kiwifruit
industry consider KASUMIN is likely to be effective in the fight against Psa-V and thus would
have a high level of benefits.
2.12. Submitters also raised concerns that there was insufficient information provided to assess the
risk to bees. The Committee noted that the staff requested study data on the effects of
kasugamycin on bee larvae, but this was not provided.
2.13. Two submitters initially requested to be heard at a public hearing for the application for approval
of KASUMIN, but withdrew their requests after distribution of the Evaluation and Review (E&R)
Report.
Evaluation and Review Report
2.14. The staff of the EPA (“the staff”) prepared an E&R Report to aid the Committee in its decisionmaking process. The E&R Report is the staff review of the application and assessment of the
potential risks, costs and benefits to human health, environment, Māori, society and community,
and to the market economy. The E&R Report also included an assessment of the submissions
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received and a suite of proposed risk management controls that might be implemented in order
to mitigate the risks presented by the substance.
2.15. Confidential information was provided by the applicant, which was taken into account in the staff
assessment of KASUMIN. The confidential information included the following:

Formulation composition details

Toxicological and ecotoxicological study data and reports.

Environmental fate study data and reports.
Further information
2.16. The staff advised the Committee that the application did not contain sufficient information to
undertake a full assessment of the substance from a scientific and technical perspective.
2.17. During the submission period, staff began conducting a risk assessment of KASUMIN. They
identified that a large number of the studies which had been provided to the Pest Management
Regulatory Agency (PMRA) for registration in Canada, were not provided to the EPA. Those
studies were requested to provide:

information on the toxicity of KASUMIN;

information on the environmental fate of KASUMIN; and

information on the ecotoxicity of KASUMIN.
2.18. Further information on the toxicity, environmental fate and ecotoxicity of KASUMIN was
requested of the applicant following the close of submissions in accordance with section 58 of
the Act. Consequently the consideration was postponed to allow for this further information to
be provided and assessed.
2.19. In response to this information request, the applicant has provided most of the requested
studies to the EPA. However, some of the requested studies are still not available, and the staff
considered that a complete assessment of all risks associated with the release of KASUMIN
was not possible. As a result, the staff advised the Committee that they were able to undertake
an assessment with the available information but there was significant uncertainty regarding
some of the risks associated with application of KASUMIN in the manner proposed by the
applicant.
2.20. In response to the E&R Report, the applicant provided a document to the EPA, containing
contextual background information on KASUMIN and the effects of Psa-V on the kiwifruit
industry, the benefits of KASUMIN, use of KASUMIN internationally, and discussion on the
proposed restricted entry intervals.
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3. Consideration
Information review
3.1.
The following information was available to the Committee:

The application

The submissions (Appendix B of the E&R Report)

The E&R Report

The additional information provided by the applicant in response to requests and the
E&R report.
3.2.
The E&R Report is advice provided to the Committee by the staff. The Committee may decide
to adopt the staff position presented in the E&R Report, or deviate from that position to the
extent that it considers appropriate when making its decision on the application.
3.3.
The Committee noted that there were significant gaps, as identified by the staff. The Committee
considered it had sufficient information to make a decision on the application, but noted that the
proposed controls to address risks to re-entry workers required particular attention given the
applicant’s comments that the proposed restricted entry intervals were not practical. Further
discussion is provided below.
Hazardous properties
3.4.
The Committee adopted the KASUMIN hazard classification profile recommended by the staff,
based on the information provided by the applicant and on other available information as
documented in the E&R Report (Table 1).
Table 1: Hazard classification of KASUMIN
3.5.
Hazard Endpoint
EPA classification
Acute toxicity
6.1E (dermal, inhalation)
Reproductive/developmental
toxicity
6.8B
Target organ systemic toxicity
6.9B
KASUMIN has not been classified as ecotoxic. However, the Committee noted that there are a
number of significant gaps related to ecotoxicity in the data package provided for KASUMIN,
which prevented a complete classification and assessment from being undertaken.
Risk and benefit assessment
3.6.
The Committee noted the staff’s risk assessment for KASUMIN as detailed in the E&R Report.
In particular, the Committee noted the lack of data provided with the application in relation to
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effects on the environment and human health presented by KASUMIN. A summary of the key
points of the risk assessment though the lifecycle of KASUMIN follows.
Risks during manufacture and packaging
3.7.
The Committee noted that the applicant intends to import KASUMIN into New Zealand.
However, it is possible that the substance could be manufactured in New Zealand in the future.
Consequently, the risks associated with the manufacture of KASUMIN have been evaluated.
Therefore, the Committee considered that any approval of this substance will be applicable to
both the import and manufacture of KASUMIN.
3.8.
The Committee considered that adherence to HSNO controls (such as labelling, emergency
management and secondary containment) will ensure that the level of risk to human health or
the environment in New Zealand during import or manufacture of KASUMIN will be negligible.
Risks during importation, transport and storage
3.9.
The Committee considered that workers and bystanders will only be exposed to the substance
during transport and storage in isolated incidents where spillage occurs.
3.10. Once in New Zealand, HSNO controls (e.g. labels, safety data sheets (SDS), packaging,
emergency management and secondary containment) and adherence to the Land Transport
Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable) will apply.
3.11. Assuming compliance with the HSNO controls, the Committee considered that:

the likelihood of a person being repeatedly exposed to the substance during transport
and storage will be so low that the resulting level of risk to human health will be
negligible;

the level of risk to the environment in New Zealand during transportation and storage of
KASUMIN is negligible.
Risks during use
3.12. The staff advised the Committee that KASUMIN is intended to be handled and applied in similar
ways to other approved agricultural bactericide substances, such as streptomycin-containing
substances.
Environmental effects
3.13. The staff advised the Committee that the level of risks presented to the environment through
use of KASUMIN were:

NEGLIGIBLE risks to non-target plants and terrestrial vertebrates

LOW acute and chronic risks to aquatic organisms

LOW acute risks to earthworms in-field and beyond the application area.

MEDIUM risks to terrestrial invertebrates
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3.14. No relevant data were provided with the application to allow quantitative assessment of the
following:

Effects of kasugamycinic acid, a significant metabolite or kasugamycin, on the aquatic
environment

Chronic risks to earthworms

Potential of recovery or recolonisation of bees
In light of these data gaps, the Committee considered that there is a significant degree of
uncertainty associated with the environmental risk assessment of the use of KASUMIN.
3.15. The Committee considered that use of additional controls is required to minimise the risks to the
environment, such as prohibiting application into, onto or over water, specifying maximum
application rates, frequencies and intervals, and restricting use of KASUMIN to ground-based
application only.
Human health effects
3.16. The staff advised the Committee that the acute exposure risks to operators, re-entry workers
and bystanders was qualitatively assessed to be negligible provided the HSNO controls (e.g.
labels, SDS, packaging) are complied with and PPE is used when handling and applying the
substance.
3.17. The chronic exposure risks associated with KASUMIN have been qualitatively assessed. The
staff determined that risks to re-entry workers may be reduced to negligible if sufficiently long
restricted entry intervals (REIs) are imposed. The staff determined that the REIs should be 30
days if gloves are worn, or 40 days with no use of PPE. The staff noted that these values were
arrived at on the basis that no data (i.e. dislodgeable foliar residues, foliar degradation rate and
dermal absorption values) were provided and consequently default values were used in the
modelling calculations.1 The staff advised the Committee that, given the data gaps, the risk
assessment was conservative and that if shorter REIs are adopted, the risks to re-entry workers
will still be non-negligible.
3.18. The chronic risks to bystanders are considered to be managed by the measures required to
protect the environment (i.e. restricting to ground-based application), and are therefore
negligible.
Risks during disposal
3.19. The applicant indicated that the preferred method is to use the product completely (until totally
consumed) according to label directions. The staff advised the Committee that disposal of the
substance and used containers in accordance with the requirements of the Hazardous
Substances (Disposal) Regulations 2001 will ensure individuals and the environment are not
1
The staff noted that the applicant subsequently provided information that allowed the staff to refine the dermal
absorption value used in the exposure modelling detailed in the E&R report. The effect of this was a reduction in the REI
values to 7 days (if gloves are worn) or 17 days with no use of PPE. Further details are provided in paragraph 4.7.2.
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exposed to the substance. The Committee considered that the level of risk to human health and
the environment will be negligible.
Relationship of Māori to the Environment
3.20. The staff advised the Committee that the hazards of KASUMIN have the potential to inhibit
iwi/Māori in fulfilling their role of kaitiaki particularly in regard to the negative effect on the
general health and well-being of individuals and the community.
3.21. The staff considered that the risks to Māori culture or traditional relationships with ancestral
lands, water sites, wāhi tapu, valued flora and fauna or other taonga are likely to be negligible.
3.22. In addition, there is no evidence to suggest that the controlled use of KASUMIN is likely to
breach the principles of Te Tiriti o Waitangi/The Treaty of Waitangi.
3.23. The Committee agreed with the assessment of the staff on the impacts on the relationship of
Māori to the Environment.
Assessment of risks to society, the community and the market economy
3.24. The staff advised that they consider that there are not expected to be any significant adverse
impacts on the social environment with the controlled use of KASUMIN, apart from the possible
health effects and environmental effects already discussed. Accordingly, the Committee
considered the risks to society, the community and the market economy are negligible.
Overall assessment of risks and approach to risk
3.25. In considering its approach to this assessment, the Committee acknowledged that the staff’s
risk assessment was carried out with limited data available, which resulted in a significant level
of uncertainty regarding the environmental assessment and the determination of appropriate
restricted entry intervals. The Committee has taken a precautionary position and accepted the
risk assessment provided by the staff, which identified non-negligible risks to human health and
the environment.
3.26. The Committee considered that additional controls are required to adequately manage the risks
to human health and the environment, and that compliance with the default and additional
controls will ensure that the risks associated with KASUMIN are mitigated. The Committee
noted that the environmental risks can be reduced through use of additional controls, but are
still considered to be non-neglibible. The level of risks to human health may remain nonnegligible, depending on the length of the restricted entry intervals specified, which needed to
include a consideration of the practicality for users of the length of the REI proposed.
3.27. The staff advised the Committee that the level of risk presented by KASUMIN is expected to be
no greater than for existing streptomycin-containing bactericides, and is expected to be used as
an alternative treatment to those existing bactericidal substances. The HSNO approvals for
existing streptomycin-containing substances used in horticulture were granted during the
transfer process in 2004. When staff considered the re-entry risks posed by those substances
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using current methodology, they found a very similar level of risk to that predicted by the model
for KASUMIN. By making KASUMIN available, with restricted entry intervals imposed and
complied with, the Committee considered that risks to operators would not be increased, and
would likely provide an improved working environment for applicators and re-entry workers
handling these kinds of pesticides.
New Zealand’s international obligations
3.28. The staff advised the Committee that they did not identify international obligations that may be
impacted by the approval of KASUMIN.
Overall assessment of benefits
3.29. The applicant identified that the use of KASUMIN will provide the following benefits:

the use of a new antibiotic ingredient that does not have additional uses as a human or
veterinary medicine, thus avoiding any issues with antibiotic resistance;

KASUMIN will be an additional tool as part of a resistance management programme for
kiwifruit production, based on a different mode of action when compared to streptomycinbased products;

reducing the economic damage caused by Psa-V to the kiwifruit industry as KASUMIN is
expected to be a key tool in managing Psa-V; and

replacing more harmful current control methods (e.g. streptomycin-based products).
3.30. The Committee was satisfied that the availability of KASUMIN will provide an alternative option
for managing Psa-V and minimising impacts on the kiwifruit industry. The Committee noted that
these benefits are only able to be realised if KASUMIN is available to the market, and if use of
KASUMIN is subject to controls that are practical for end-users. If this is the case, then there
are beneficial economic effects for some businesses and kiwifruit growers, and flow-on effects
to local communities and the New Zealand economy as a result of the availability of KASUMIN.
The effects of the substance being unavailable
3.31. The Committee considered that, if KASUMIN were unavailable, the benefits associated with the
availability of the substance would not be realised. In particular, the kiwifruit industry would not
gain access to a new tool which they consider very important for the control of Psa-V.
4. Controls
4.1.
Based on the hazard classification determined for KASUMIN, a set of associated default
controls specified by regulations under the Act has been identified by the Committee as being
applicable to KASUMIN. The default controls form the basis of the controls set out in Appendix
A. Based on its risk assessment, the Committee considered that the additions, variations and
deletions set out below should be included in the controls for KASUMIN.
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The setting of exposure limits
4.2.
Tolerable Exposure Limits (TELs) can be set to control hazardous substances entering the
environment in quantities sufficient to present a risk to people. No TELs have been set for any
component of KASUMIN at this time as the risk to bystanders is considered negligible. The EPA
is however, required to set ADE and PDE values for new active ingredients that may become
present in food, to allow the setting of Maximum Residue Levels (MRLs) by MPI. The staff
propose setting the following ADE and PDE values:
4.3.

Acceptable Daily Exposure (ADE) = 0.113 mg/kg bw/d

Potential Daily Exposure (PDEfood) = 0.08 mg/kg bw/d

Potential Daily Exposure (PDEdrinking water) = 0.023 mg/kg bw/d

Potential Daily Exposure (PDEother) = 0.11 mg/kg bw/d
The EPA typically adopts Workplace Exposure Standard (WES) values listed in the Ministry of
Business, Innovation and Employment’s WES Document to control exposure in places of work.
MBIE has set a WES value for Component D, but due to the low concentration at which it is
present in the formulation, this has not been applied to KASUMIN.
Additional controls
4.4.
The staff advised the Committee that the environmental risk assessment indicates that
restrictions on use are necessary to ensure that the risks KASUMIN presents to the aquatic
environment are negligible, and to mitigate risks to terrestrial invertebrates. The Committee
agreed and consequently, the following additional controls are applied to KASUMIN to restrict
the level of risk to the environment:
4.5.

KASUMIN must not be applied onto, over or into water.

KASUMIN must only be applied via ground-based methods.
The staff advised the Committee that the environmental exposure modelling indicates there may
be a risk where the substance is used outside the specific parameters of the risk assessment.
The Committee agreed and considered that maximum application rates, frequencies and
intervals should be set to ensure that the risks KASUMIN presents to the aquatic environment
are negligible, and to mitigate risks to terrestrial invertebrates:

KASUMIN may be applied at a maximum application rate of 100 g kasugamycin/ha per
application; and up to four applications of KASUMIN per year, with a minimum interval of
10 days between applications.
4.6.
The staff advised the Committee that users of KASUMIN need to be aware of the active
ingredient contained in the substance, in order to be aware of the substance’s associated risks.
Additionally, due to the high concerns around the risks posed to non-target arthropods, the staff
advised that the label should include a statement identifying the potential risk to beneficial
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organisms. Additionally, the applicant requested a modification to the staff’s proposed label
wording, to replace the word ‘antibiotic’ with ‘bactericide’. The Committee agreed with the staff
advice and were satisfied that the proposed wording change does not change the intent of the
control.

The following statement must appear on the label:
KASUMIN contains the bactericide, kasugamycin, and may be harmful to beneficial
organisms such as predatory mites, earthworms, and bees and other pollinator species.
4.7.
The staff advised the Committee that the risk assessment identified potential risks to workers
entering an area after application of KASUMIN. The Committee noted that the staff risk
assessment could be interpreted as being conservative, given that it involved the use of
conservative default values due to the lack of available data on dislodgeable foliar residues, but
agreed that the use of KASUMIN presents a risk to re-entry workers that requires mitigation.
4.7.1. In order to mitigate this risk, a Restricted Entry Interval (REI) was proposed in the E&R
Report. The applicant provided comment on the staff’s proposal, indicating that they
considered the time-periods specified were too long to be practical, and that users would
simply not use KASUMIN, or if they did, the control would not be complied with.
4.7.2. The applicant suggested that based on the physico-chemical properties of the substance,
a dermal absorption value of 50% was unrealistic, and this should be refined. The staff
accepted this argument and used an internationally recognised method of estimating
dermal absorption values in the absence of data. The staff remodelled the re-entry risks
with a refined value of 10%, and determined that the REIs should be 7 days if gloves are
worn, or 17 days with no use of PPE.
4.7.3.The Committee agreed with the staff that REIs will be an effective risk mitigation tool for
re-entry workers, but stressed that the length of the REI needs to be a balance between
risk mitigation and practicality for users. The Committee noted that the REI conditions
specified below may not sufficiently mitigate the risks to re-entry workers so that the risks
can be considered to be negligible. However, the Committee considered that these REI
conditions offer significant improvements in terms of practicality for end users of
KASUMIN, and the risks will be sufficiently mitigated to ensure that the benefits offered by
KASUMIN will outweigh these risks.

The Committee considered that workers should be restricted from entering a
treated area for a period of time immediately after application because of the risks
associated with exposure to residual spray in the air and the wet surfaces of
treated plants. A worker entering the treated area within 48 hours of completion of
the application is only permitted if PPE is worn as if the person is applying
KASUMIN.
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
After the initial 48 hours of completion of an application, the Committee considered
the risks to re-entry workers arise through dermal contact with the dried substance
on foliage. The applicant indicated that there were a number of operations that are
necessary after application and workers require access to the treated area within
the REI to carry out tasks such as canopy inspections and minor crop maintenance
(e.g. shoot removal). The Committee considered that re-entry into the treated area
within the REI should be permitted, provided dermal contact with treated crops (i.e.
foliage and fruit) is avoided by wearing appropriate PPE (including gloves).
4.7.4. Additionally, in order to ensure that end-users are made aware of these requirements, the
necessity of adhering to REIs must be stated on the product label. Accordingly, the
Committee imposed the following control on KASUMIN, noting that the risks are
considered to be non-negligible, but will be sufficiently managed, while allowing
KASUMIN to be effectively used and the benefits realised:

Restricted Entry Interval (REI) 2
(1) The REI for this substance is 7 days.
(2) The person in charge of the application area shall ensure that no person who
is authorised to be there enters the application area until the end of the REI,
unless:
(a) the person entering the application area is wearing PPE as if that person
is applying the substance; or
(b) at least 48 hours have elapsed since completion of the most recent
application of KASUMIN and the person entering the application area is
wearing appropriate clothing and gloves, to prevent dermal contact with
treated plants.
LABEL STATEMENT
(3) A person must not supply KASUMIN to any other person unless the substance
label shows the requirements for the REIs and corresponding PPE, in
accordance with (1) and (2).
(4) A person who is in charge of a hazardous substance must ensure that the
substance label shows the information required by (3).
4.8.
The staff advised the Committee that bystanders and/or sensitive areas require protection
against exposure arising from off-target deposition of the substance. The Committee agreed
with the staff’s recommendation and considered that application of the substance is permitted
provided that measures are implemented by the applicator to ensure that off-target deposition
2
Restricted Entry Interval (REI) means the period of time which must elapse from the latter of—
(a) when the substance was last applied to the application area; or
(b) where the application area is within a building or enclosed structure, when ventilation of the structure is
commenced.
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(i.e. spray drift) is sufficiently minimised to ensure that adverse effects beyond the property
boundary do not occur. The control is intended to provide applicators with the flexibility to adopt
whatever drift-mitigation measures are appropriate to their situation. The measures could
include (but not be limited to) those in the New Zealand Standard NZS8409:2004 Management
of Agrichemicals. This details various spray drift reduction measures that can be
implemented.e.g. use of particular application technologies or techniques or the use of shelter
belts, Accordingly, the Committee imposed the following control on KASUMIN:

Spray drift mitigation
(1) No person may apply the substance in a manner that results in adverse effects
beyond the boundary of the subject property.
(2) A person applying the substance must take all practicable steps to avoid off-target
movement of the substance.
LABEL STATEMENT
(3) The following statement must appear on the substance label:
The person applying this substance must not cause adverse effects beyond the
boundary of the treated property, and must also avoid adverse effects from spray
drift occurring. Mitigation measures employed must be recorded as part of the
application records.
(4) A person must not supply a hazardous substance to any other person unless the
substance label includes the statement specified in (3).
(5) A person who is in charge of a hazardous substance must ensure that the substance
label shows the information required by (3).
4.9.
The Committee considered that the use and details of the spray drift mitigation measures
implemented should be recorded for the use of KASUMIN. The staff advised the Committee that
the default control for maintaining records of use was not proposed in the E & R report.
However, the Committee considered that use of KASUMIN should be subject to the
requirements of control T3 (regulations 5 and 6 of the Hazardous Substances (Classes 6, 8,
and 9 Controls) Regulations 2001). Additionally, the staff advised the Committee that the details
of the content of the application records should also include details of the spray drift mitigation
measures implemented. Accordingly, the Committee imposed the requirements of control T3,
and modified the control to include details of the spray drift mitigation measures implemented.
The full details of this control are provided in Appendix A.
4.10. The staff advised the Committee that the environmental risk assessment highlighted several
areas of potential risk, and the staff considered an appropriate way to mitigate some of this risk
is by ensuring all persons applying the substance are qualified to do so. The Committee agreed
with the staff advice and imposed an approved handler requirement for all phases of the
lifecycle of KASUMIN, with the exception of transportation, where an exception is provided for
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persons transporting hazardous substances who have a dangerous goods endorsement on
their driver licence. The full details of this control are provided in Appendix A.
4.11. The Committee noted that the default controls do not address the risks associated with storage
or use of the substance within stationary container systems (e.g. tanks). These risks include
the failure of primary containment resulting in a large spill of the substance into the
environment. In addition, the default controls do not allow for dispensation where it is
unnecessary for any pipework associated with the stationary container systems to have
secondary containment. The revised controls are shown in Appendix A.
4.12. The Committee considered that the additional controls discussed in paragraphs 4.1 to 4.11 will
be more effective than the default controls in terms of their effect on the management, use and
risks of the substance, in accordance with section 77A(4)(a) of the Act.
4.13. The default controls include requirements for secondary containment of pooling substances.
The Committee considered that the risks associated with the containment of substances which
are not class 1 to 5 substances (i.e. do not ignite or explode) are different to those associated
with class 1 to 5 substances. Consequently the secondary containment requirements can be
reduced. The Committee considered that these reduced secondary containment measures are
adequate to manage the risks of a spillage of KASUMIN. Therefore, the proposed variation is
more cost-effective in terms of managing the risks of the substance, which is in accordance with
section 77A(4)(b) of the Act. The revised controls are shown in Appendix A.
Review of controls for cost-effectiveness
4.14. The Committee considered that the proposed controls, provided they are complied with, are the
most cost-effective means of managing the identified potential risks associated with this
application. The applicant provided feedback on the proposed controls as detailed in the E&R
Report, which was taken into account by the Committee when setting the controls appropriate
for this substance.
5. Environmental user charges
5.1.
The Committee considered that applying controls on KASUMIN is an effective means of
managing risks associated with this substance. Therefore, it is not considered necessary to
apply environmental user charges to this substance as an alternative or additional means of
achieving effective risk management. Accordingly, no report has been made to the Minister for
the Environment.
6. Conclusion
6.1.
Taking into account the staff assessment of the potential risks and benefits associated with
KASUMIN (see section 5), the Committee considered that, with controls in place:
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
the overall risks to human health and the environment arising from the hazardous
properties (effects on reproductive/developmental toxicity, target organ systemic toxicity,
effects on soil-dwelling organisms and terrestrial invertebrates) and the use of KASUMIN
are non-negligible;

significant adverse impacts on the social or economic environment from the use of
KASUMIN are not anticipated;

significant impacts on Māori culture or traditional relationships with ancestral lands,
water, sites, wāhi tapu, valued flora and fauna or other taonga that will breach the
principles of the Te Tiriti o Waitangi/Treaty of Waitangi are not anticipated; and

significant benefits will be derived for New Zealand by allowing the use of KASUMIN,
particularly as a tool in the management of Psa-V.
7. Decision
7.1.
Pursuant to section 29 of the Act, the Committee has considered this application to import a
hazardous substance for release made under section 28 of the Act. In doing so, the Committee
has applied the relevant sections of the Act and clauses of the Hazardous Substances and New
Organisms (Methodology) Order 1998 (“the Methodology”) as detailed in the decision path and
3
explanatory notes available from our website .
7.2.
The Committee was satisfied with the hazard classifications identified in Table 1 and
accordingly has applied these to KASUMIN.
7.3.
The Committee considered that, with controls in place, the overall risks associated with release
of KASUMIN are non-negligible. The Committee considered that the benefits associated with
the release of KASUMIN are also non-negligible and sufficiently significant to outweigh the nonnegligible risks presented by KASUMIN. Therefore, the Committee considered that the
application could be approved in accordance with clause 27.
7.4.
The Committee approves the importation of the hazardous substance KASUMIN with controls
as listed in Table 2 (Appendix A). The Committee was also satisfied that, as the manufacture of
KASUMIN would not impose any additional risks over the importation of the substance, this
approval should apply to both importation and manufacture of KASUMIN.
Louise Malone
Chair, Decision Making Committee
Environmental Protection Authority
3
Date: 18 October 2013
HSR100889
http://www.epa.govt.nz/publications/er-pr-02-decision-paths.pdf
www.epa.govt.nz
Appendix A: Controls applying to KASUMIN
Notes: The controls for this substance apply for the indefinite duration of the approval of this
substance.
Please refer to the Hazardous Substances Regulations4 for the requirements prescribed for each
control and the modifications listed as set out in Section 5 of this document.
Table 2: Controls for KASUMIN – codes, regulations and variations
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code
T1
Regulation
11 – 27
Description
Limiting exposure to toxic substances
through the setting of TELs
Variation
No TELs values are set for any
component of the substance at this
time; however, the following ADE and
PDE values have been set for
kasugamycin:
ADE = 0.113 mg/kg bw/day
PDEfood = 0.08 mg/kg bw/day
PDEdrinking water = 0.023 mg/kg
bw/day
PDEother = 0.011 mg/kg bw/day
T2
29, 30
Controlling exposure in places of work
through the setting of WESs.
No WES values have been set for any
component of this substance at this
time.
The following subclause is added to
regulation 6(1) of the Hazardous
Substances (Classes 6, 8, and 9
Controls) Regulations 2001, after
subclause (g):
4
T3
5(1), 6
Requirements for keeping records of
use
T4
7
Requirements for equipment used to
handle substances
T5
8
Requirements for protective clothing
and equipment
T7
10
Restrictions on the carriage of toxic or
corrosive substances on passenger
service vehicles
(h)
details of measures taken to
ensure that there are no
adverse effects beyond the
boundary of the subject property
into an adjoining property or
sensitive area.
The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz
www.epa.govt.nz
Hazardous Substances (Identification) Regulations 2001
Code
Regulation
Description
I1
6, 7, 32 –
35, 36(1) –
(7)
Identification requirements, duties of
persons in charge, accessibility,
comprehensibility, clarity and
durability
I8
14
Priority identifiers for toxic
substances
I9
18
Secondary identifiers for all
hazardous substances
Variation
The concentration cut-offs that
trigger the requirement for labelling
of components are set out in the
following table:
HSNO
Cut-off for label
Classification
% (I16)
6.5A, 6.5B, 6.6A,
I16
25
Secondary identifiers for toxic
substances
I17
26
Use of generic names
I18
27
Requirements for using concentration
ranges
I19
29 – 31
Additional information requirements,
including situations where
substances are in multiple packaging
I21
37 – 39, 47
– 50
General Documentation requirements
I28
46
Specific Documentation requirements
for toxic substances
I30
53
Advertising corrosive and toxic
substances
6.7A
0.1
6.6B
1
6.7B
1
6.8A, 6.8C
0.3
6.8B
3
6.9A, 6.9B
10
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Hazardous Substances (Packaging) Regulations 2001
Code
Regulation
Description
P1
5, 6, 7(1), 8
General packaging requirements
P3
9
Criteria that allow substances to be
packaged to a standard not meeting
Packing Group I, II or III criteria
P13
19
Packaging requirements for toxic
substances
PS4
Schedule 4
Packaging requirements as specified
in Schedule 4
Variation
Hazardous Substances (Disposal) Regulations 2001
Code
Regulation
Description
D4
8
Disposal requirements for toxic and
corrosive substances
D6
10
Disposal requirements for packages
D7
11, 12
Information requirements for
manufacturers, importers and
suppliers, and persons in charge
D8
13, 14
Documentation requirements for
manufacturers, importers and
suppliers, and persons in charge
Variation
Hazardous Substances (Emergency Management) Regulations 2001
Code
Regulation
Description
EM1
6, 7, 9 – 11
Level 1 information requirements for
suppliers and persons in charge
EM6
8(e)
Information requirements for toxic
substances
EM8
12 – 16, 18
– 20
Level 2 information requirements for
suppliers and persons in charge
Variation
Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004
Code
Regulation
Description
Tank
Wagon
4 to 43 as
applicable
Controls relating to tank wagons and transportable containers.
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Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)
Transfer Notice 2004
Code
Regulation
Description
Sch 8
Schedule 8
This schedule prescribes the controls
for stationary container systems. The
requirements of this schedule are
detailed in the consolidated version of
the Hazardous Substances (Dangerous
Goods and Schedule Toxic
Substances) Transfer Notice 2004,
available from
http://www.epa.govt.nz/Publications/Tra
nsfer-Notice-35-2004.pdf
Variation
Additional controls
Code
Regulation
Description
Water
77A
This substance must not be applied onto, over or into water5
App Rate
77A
KASUMIN may be applied at a maximum application rate of 100 g
kasugamycin/ha per application, and up to four applications of
KASUMIN per year, with a minimum interval of 10 days between
applications.
Ground
Bas
77A
KASUMIN must only be applied via ground-based methods6
R-12
77A
Restricted Entry Interval (REI)7
(1)
The REI for this substance is 7 days.
(2)
The person in charge of the application area shall ensure that no
person who is authorised to be there enters the application area
until the end of the REI, unless:
(a)
the person entering the application area is wearing PPE as if
that person is applying the substance; or
(b)
at least 48 hours have elapsed since completion of the most
recent application of KASUMIN and the person entering the
application area is wearing appropriate clothing and gloves,
to prevent dermal contact with treated plants..
LABEL STATEMENT
(3)
A person must not supply KASUMIN to any other person unless
5
Where "water" means water in all its physical forms, whether flowing or not, and whether over or under ground, but
does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to
application or water used in the dilution of the substance prior to application or water used to rinse the container after
use
6
Ground-based methods of applying pesticides include, but are not limited to, application by ground boom, airblast or
knapsack, and do not include aerial application methods.
7
Restricted Entry Interval (REI) means the period of time which must elapse from the latter of—
(a) when the substance was last applied to the application area; or
(b) where the application area is within a building or enclosed structure, when ventilation of the structure is commenced.
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Code
Regulation
Description
the substance label shows the requirements for the REIs and
corresponding PPE, in accordance with (1) and (2)
(4)
R-13
77A
A person who is in charge of a hazardous substance must ensure
that the substance label shows the information required by (3).
Approved handler requirements
(1)
The requirements of regulation 9 of Hazardous Substances
(Classes 6, 8, and 9 Controls) Regulations 2001, and regulations
4 to 6 of Hazardous Substances (Personnel Qualifications)
Regulations 2001 apply to this substance.
LABEL STATEMENT
(2)
A person must not supply a hazardous substance to any other
person unless the substance label specifies that the substance
must only be applied by an approved handler, or under the direct
supervision of an approved handler.
(3)
A person who is in charge of a hazardous substance must ensure
that the substance label shows the information required by (2).
This regulation is inserted immediately after regulation 9:
9A Exception to approved handler requirement for transportation
of packaged substances
(1)
Regulation 9 is deemed to be complied with if—
(a)
(b)
(c)
(2)
in the case of a hazardous substance being transported on
land,—
(i)
in the case of a substance being transported by rail, the
person who drives the rail vehicle that is transporting
the substance is fully trained in accordance with the
approved safety system for the time being approved
under section 6D of the Transport Services Licensing
Act 1989; and
(ii)
in every other case, the person who drives, loads, and
unloads the vehicle that is transporting the substance
has a current dangerous goods endorsement on his or
her driver licence; and
(iii)
in all cases, Land Transport Rule: Dangerous Goods
1999 (Rule 45001) is complied with; or
in the case of a hazardous substance being transported by
sea, one of the following is complied with:
(i)
Maritime Rules: Part 24A – Carriage of Cargoes –
Dangerous Goods (MR024A):
(ii)
International Maritime Dangerous Goods Code; or
in the case of a hazardous substance being transported by
air, Part 92 of the Civil Aviation Rules is complied with.
Subclause (1)(a)—
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Code
Regulation
Description
(3)
(4)
R-4
77A
(a)
does not apply to a tank wagon or a transportable container
to which the Hazardous Substances (Tank Wagons and
Transportable Containers) Regulations 2004 applies; but
(b)
despite paragraph (a), does apply to an intermediate bulk
container that complies with chapter 6.5 of the UN Model
Regulations.
Subclause (1)(c)—
(a)
applies to pilots, aircrew, and airline ground personnel
loading and managing hazardous substances within an
aerodrome; but
(b)
does not apply to the handling of a hazardous substance in
any place that is not within an aerodrome.
In this regulation, UN Model Regulations means the 17th revised
edition of the Recommendation on the Transport of Dangerous
Goods Model Regulations, published in 2011 by the United
Nations.
Spray drift mitigation
(1)
No person may apply the substance in a manner that results in
adverse effects beyond the boundary of the subject property.
(2)
A person applying the substance must take all practicable steps to
avoid off-target movement of the substance.
LABEL STATEMENT
(3)
The following statement must appear on the substance label:
The person applying this substance must not cause adverse
effects beyond the boundary of the treated property, and must
also avoid adverse effects from spray drift occurring. Mitigation
measures employed must be recorded as part of the application
records.
Label
77A
(4)
A person must not supply a hazardous substance to any other
person unless the substance label includes the statement
specified in (3).
(5)
A person who is in charge of a hazardous substance must ensure
that the substance label shows the information required by (3).
The label must include the following statement:
KASUMIN contains the bactericide, kasugamycin, and may be harmful
to beneficial organisms, such as predatory mites, earthworms and bees
and other pollinators.
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Appendix B: Confidential Information
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