DECISION - EPA · 6/17/2016 · 4.20. Aquatic plants offer a habitat and protection for small fish...
Transcript of DECISION - EPA · 6/17/2016 · 4.20. Aquatic plants offer a habitat and protection for small fish...
DECISION
www.epa.govt.nz
17 June 2016
Summary
Substance Fodder Beet Smooth
Application code APP202824
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 Global Agrichem Limited
Purpose of the application To import Fodder Beet Smooth, a post-emergence herbicide
containing the active ingredients desmedipham, phenmedipham,
ethofumesate and metamitron for the control of broad leaf weeds in
fodder beet, sugar beet and red beet
Date application received 5 May 2016
Consideration date 17 June 2016
Considered by The Chief Executive1 of the Environmental Protection Authority (“the
EPA”)
Decision Approved with controls
Approval code HSR101145
Hazard classifications 6.1D(All) 6.1E (oral), 6.1E(dermal), 6.1D (inhalation), 6.3B, 6.4A,
6.5B, 6.7B, 6.9B (oral), 9.1A, 9.2A, 9.3C
1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.
2
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
1. Substance
1.1. Fodder Beet Smooth is an emulsifiable suspension containing 60 g/litre desmedipham, 60 g/litre
phenmedipham, 60 g/litre ethofumesate and 200 g/litre metamitron as the active ingredients. It is
intended for use by professionals as post-emergence herbicide for the control of broad leaf weeds in
fodder beet, sugar beet and red beet.
2. Process and notification
Application receipt
2.1. The application was formally received on 5 May 2016 under section 28 of the Act.
Information available for consideration
2.2. The information available for consideration includes:
the application form
confidential appendices to the application
the EPA staff advice memorandum.
2.3. I consider that I have sufficient information to assess the application.
Public notification
2.4. This application was not publicly notified under section 53(2) of the Act because it was unlikely that
there would be significant public interest in the application.
Notification to government departments
2.5. Pursuant to section 53(4) of the Act, the following government departments were notified of the
application on 6 May 2016: WorkSafe New Zealand, the Ministry for Primary Industries (Agricultural
Compounds and Veterinary Medicines group), and the Department of Conservation. No comments
were received.
Legislative criteria for the application
2.6. The application was considered in accordance with section 29 of the Act, taking into account other
relevant sections of the Act, the Hazardous Substances Regulations and the Hazardous Substances
and New Organisms (Methodology) Order 1998.
3. Hazardous properties
3.1. The hazard classification of Fodder Beet Smooth were determined based on the information provided
by the applicant and other available information.
3
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
3.2. The classifications that I have applied to this substance are different from those submitted by the
applicant (Table 1). The difference in classifications has arisen due to an additional exposure route not
being identified by the applicant.
Table 1: Hazard classifications for Fodder Beet Smooth
Hazard Applicant classifications EPA classifications
Acute toxicity (oral) 6.1E 6.1E
Acute toxicity (dermal) - 6.1E
Acute toxicity (inhalation) 6.1D 6.1D
Skin irritancy 6.3B 6.3B
Eye irritancy 6.4A 6.4A
Contact sensitisation 6.5B 6.5B
Carcinogenicity 6.7B 6.7B
Target organ or systemic toxicity (oral) 6.9B 6.9B
Aquatic ecotoxicity 9.1A 9.1A
Soil ecotoxicity 9.2A 9.2A
Terrestrial vertebrate ecotoxicity 9.3C 9.3C
4. Risk and benefit assessment
Prescribed controls
4.1. The hazard classifications of Fodder Beet Smooth determine a set of prescribed controls specified by
the Hazardous Substances Regulations under the Act.
4.2. The prescribed controls set the baseline for how the substance will be managed while in New Zealand
and include specifications on how the substance is to be packaged, labelled, stored, disposed of,
transported, handled and used. The prescribed controls also set requirements for information, signage
and emergency management. These controls form the basis of the controls specified in Appendix A.
Risk assessment
4.3. The risk assessment takes into account the prescribed controls and other legislation such as the Land
Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994.
4.4. The risk assessment:
considers the risks posed by Fodder Beet Smooth
determines whether the risks are outweighed by the benefits, and
determines whether any variations or additions to the prescribed controls are required to
manage the risks of this substance, and identifies controls that may not be applicable or
necessary and can be deleted.
4
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Assessment of risks to human health and the environment
4.5. I have assessed the human health and environmental risks in accordance with Section 29(1) of the
Act, which took into account the full life cycle of the substance.
4.6. I note that Fodder Beet Smooth has the same active ingredients at similar concentrations as other
substances that are already approved, and is intended to be used in similar ways. Accordingly, the
risks to human health and the environment are not likely to be significantly higher from the use of
Fodder Beet Smooth compared to these other approved substances.
4.7. I have evaluated the potential for Fodder Beet Smooth to cause adverse effects to people and/or the
environment during each life cycle stage of the substance. I note that there are additional risks
associated with potential impurities of ethofumesate and risk to waterways. Therefore, I have placed
additional controls restricting the impurities and application.
4.8. I consider that with the controls in place, the risks to human health and the environment are reduced
to a negligible level.
Assessment of risks to Māori and their relationship to the environment
Kupu arataki (Context)
4.9. The potential effects of Fodder Beet Smooth on the relationship of Māori to the environment have
been assessed in accordance with sections 5(b), 6(d) and 8 of the Act. Under these sections, all
persons exercising functions, powers and duties under the Act shall recognise and provide for the
maintenance and enhancement of people and communities to provide for their cultural well-being, take
into account the relationship of Māori and their culture and traditions with their ancestral lands, water,
taonga and the principles of the Treaty of Waitangi (Te Tiriti o Waitangi).
4.10. I note that Fodder Beet Smooth has several hazardous properties (such as terrestrial and aquatic
ecotoxicity) that give rise to the potential for cultural risk. Cultural risk includes any negative impacts to
treasured flora and fauna species, the environment, and the general health and well-being of
individuals and the community.
4.11. I note that in general the introduction and use of hazardous substances has the potential to inhibit the
ability of Māori to fulfil their role as kaitiaki. This is particularly relevant when considering the
guardianship of land and waterways given the ecotoxic nature of Fodder Beet Smooth to Te Marae o
Tāne (terrestrial ecosystems) and Te Marae o Maru (freshwater ecosystems), in particular species
associated with mahinga kai (food resources), rongoā (medicine), pūeru (textiles), kōrero ō mua
(traditional narratives) as well as other cultural and historical associations.
Mahinga kai, rongoā me pūeru (Food resources, medicine and textiles)
4.12. With respect to Te Marae o Tāne, I note that there is the possibility of Fodder Beet Smooth harming
culturally significant terrestrial plants used for food, medicine or weaving, for example, pūhā (sow
thistle), kawakawa (pepper tree), harakeke (flax), pōhata (wild turnip), raupeti (black nightshade),
poroporo (kangaroo apple), koromiko (NZ veronica), kohukohu (chickweed), kopakopa (NZ plantain),
paewhenua (common dock) and raupō (bulrush). With respect to Te Marae o Maru, there is potential
5
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
for Fodder Beet Smooth to enter waterways and adversely affect the taonga food plant kowhitiwhiti
(watercress). Kowhitiwhiti and pūhā are iconic Māori vegetables. The importance of harakeke to Māori
in terms of textiles, equipment, art and ornamentation does not require any elaboration.
4.13. I anticipate that applications of Fodder Beet Smooth will occur on private land where access to
sprayed areas is controlled. However, there may be potential for cross boundary spray drift to
contaminate taonga species within adjoining land and waterways where access may be less
restricted. This includes plants growing in publicly accessible places such as road reserves, parks and
the margins of watercourses where taonga species may be gathered.
4.14. I note that hazardous substances can engender both direct and indirect impacts on Māori interests.
Direct impacts are the positive or adverse effects on culturally significant receptors such as taonga
species. Indirect impacts are the consequential effects, that is, how such impacts affect the ability of
Māori to express their culture, in particular customary practices and usages associated with the
affected taonga species.
4.15. For example, spray drift on kawakawa plants would render them unserviceable for a range of
traditional uses including rongoā (medicine), pare kawakawa (head wreaths for tangihanga i.e.
funerals), kawanga whare (house opening ceremony), whakainu waka (canoe launching rituals), tūā
rite (naming and tapu removal rituals for newborns and mothers) and tohi rite (dedication of children to
success and wellbeing).
4.16. The importance to Māori of ensuring that mahinga kai (food resources) and their constituent species
flourish cannot be overstated historically or contemporarily. In former times, mahinga kai were critical
for sustaining Māori communities and whānau; aquatic species formed a very important part of the
food supply. Taonga food species remain essential for continuing customary practices and meeting
cultural obligations, particularly in respect of showing manaaki (hospitality) to guests on the marae and
providing whānau with traditional kai.
Rauropi wai (Aquatic organisms)
4.17. With respect to Te Marae o Maru, I note that if Fodder Beet Smooth enters waterways there is
potential for this substance to adversely affect culturally significant food species such as tuna
(freshwater eels), piharau (lamprey), mohoao (black flounder), inanga (whitebait), kōura / kēwai
(freshwater crayfish).
4.18. Fodder Beet Smooth entering waterbodies also raises concerns regarding other culturally significant
species that spend part or all of their lifecycle in waterbodies, for example kōuraura (shrimp), piriwai
(mayfly), pūrerehua (caddisfly), pūene (dobsonfly), kapowai (dragonflies), hoehoe (water boatman),
hoe tuarā (backswimmer) and tātaka ruku (diving beetles). These are prey species for taonga food
species such as tuna, kōura / kēwai, pūtangitangi (paradise shelduck), pārera (grey duck) and rakiraki
(mallard duck), as well as culturally significant non-food species including kōkopu (galaxiids), toitoi
(bullies), kotare (kingfisher), kawau (shaga), tara (gulls) and matuku (herons).
6
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
4.19. Further in respect of Te Marae o Maru, I note that if Fodder Beet Smooth enters waterways there is
potential for this substance to adversely affect kekakeka (duckweed) and other aquatic plants, which
are a food source for culturally significant species pārera (grey duck), kuruwhengu (Australasian
shoveler duck), pāpango (NZ scaup), pāteke (brown teal), pūweto (spotless crake), and rakiraki
(mallard duck).
4.20. Aquatic plants offer a habitat and protection for small fish and invertebrates such as kōura / kēwai
(freshwater crayfish) and kōuraura (shrimp). A Māori term for freshwater plants that afford shelter in
this manner is ‘petipeti’ and the fish life it protects is known as ‘kai moe petipeti’ or food that sleeps in
water weed. Māori understand the role petipeti plays in providing a nursery and protective cover for
aquatic organisms, and there is potential for Fodder Beet Smooth to put these functions at risk.
4.21. I note that Fodder Beet Smooth may potentially harm pūkohu wai (freshwater algae). Māori observe
that Pūkohu wai are valuable to waterways as they help to purify water by absorbing nutrients from
streams and rivers – which is important for maintaining balance within and between Te Marae o
Tangaroa and Te Marae o Tāne.
4.22. Pūkohu wai are a source of food for small creatures and fish e.g. kākahi (freshwater mussel), pūpū
wai māori (water snails), kōuraura (freshwater shrimps), kanae (grey mullet), hoehoe (water boatman)
and other hātaretare (invertebrates), some of which are prey species for larger culturally significant
food species. Pūkohu wai also provide an important habitat for aquatic organisms, particularly small
invertebrates and juvenile fish.
Ngā whānote me ngā mōkai (mammals and pets)
4.23. I note that Fodder Beet Smooth may pose risk to mammals, which raises concern in relation to
culturally significant quadrupeds.
4.24. Māori may be concerned about the well-being of family pets such as dogs and cats accessing sprayed
areas with Fodder Beet Smooth then licking paws or eating prey that have been exposed to this
substance e.g. mice, rabbits, lizards. Pets are an important part of whānau and kāinga (home
environments) and are therefore integral to taha whānaunga. Fodder Beet Smooth is unlikely to pose
significant risk to pets, which owners can isolate from sprayed areas.
4.25. Dogs are of special interest to Māori because Māori have always owned and valued dogs – this
association predates European contact as Māori brought kurī (Polynesian dogs) with them to New
Zealand. Dogs are important to Māori in vocational, recreational and family settings e.g. as working
dogs, hunting dogs (especially for ‘whakangau poaka’ or pig hunting) and pets.
4.26. I do not anticipate that Fodder Beet Smooth will impact on kiore (pacific rats), as populations of this
forest dwelling taonga species are located well away from arable land where Fodder Beet Smooth will
be used. Kiore are culturally significant because they were introduced to New Zealand by Māori and a
considerable body of lore exists in relation to this species. Kiore feature in carving patterns e.g. the
Kiri-kiore (rat pelt) style from Northland, place names e.g. Motukiore (rat island) in the Hokianga
7
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Harbour, as well as a star constellation known as kiore. Māori also ate kiore which were preserved in
fat and served on special occasions.
Taha hauora (human health)
4.27. Fodder Beet Smooth is classified as a skin sensitiser and an eye corrosive. I note that it also a
suspected human carcinogen and is toxic to human organs or systems and may be acutely toxic when
inhaled, ingested orally or absorbed dermally. For these reasons, this substance poses risk to taha
hauora (human health) particularly the dimensions of taha tinana (physical health and well-being) and
taha wairua (spiritual health and well-being obtained through the maintenance of a balance with nature
and the protection of mauri).
4.28. Exposure to Fodder Beet Smooth may also inhibit taha whānaunga – the responsibility to belong, care
for and share in the collective, including relationships and social cohesion. There is a risk that using
this substance may compromise the ability of people to protect co-workers and others where it is being
used. Ensuring the collective welfare and fostering a sense of well-being and safety amongst all
involved is important for maintaining taha whānaunga.
4.29. Māori living in rural areas, or working with fodder crops, where the Fodder Beet Smooth is used may
potentially be a vulnerable group in view of the respiratory, carcinogenic and other hazard
classifications, of this substance.
4.30. I note that Māori have a significantly higher registration rates than non-Māori for cancers, and the
cancer mortality rate among Māori adults is more than 1½ times higher than non-Māori. Māori also
have significantly higher rates of respiratory disease than non-Māori. Māori aged 5 – 34 years are
almost twice as likely as non-Māori in the same age group to be hospitalised for asthma. Lung cancer
is the leading cause of death for Māori females and the second leading cause for Māori males.
Chronic obstructive lung disease among Māori aged 45 and over is almost three times the rate of non-
Māori, with corresponding hospitalisation rates of Māori being over 3½ times that of non-Māori.
Ētahi atu mea (other matters)
4.31. I note that some of the foregoing risks to environmental and human health can be mitigated by
applying controls that: Specify maximum rates and frequency of spray applications; limit use to ground
based application methods; require approved handler status; stipulate use of PPE, and; avoid
spraying into or over water.
4.32. Furthermore, controlling broad leaf weeds in fodder beet, sugar beet and red beet will produce
economic benefits for those growing or working with these crops, some of whom are Māori.
4.33. Fodder Beet Smooth provides an option that agrichemical users can consider as an alternative to
other products that are currently available for controlling broad leaf weeds in fodder beet, sugar beet
and red beet. It may also help to address the issue of broad leaf weed resistance to other
agrichemicals.
8
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Kupu whakatepe (conclusion)
4.34. Based on the information provided, including the use pattern and the controls proposed to be assigned
to Fodder Beet Smooth, I have identified that the potential risks to Māori culture or traditional
relationships with the environment should be negligible.
4.35. If Fodder Beet Smooth is applied in the prescribed manner, I consider that it is unlikely to breach the
principles of the Treaty of Waitangi, including the principle of active protection.
5. Assessment of risks to society, the community and the market economy
5.1. I have not identified any risks to society, communities or the market economy from the approval of
Fodder Beet Smooth.
New Zealand’s international obligations
5.2. I have not identified any international obligations that may be impacted by the approval of Fodder Beet
Smooth.
The effects of the substance being unavailable
5.3. I have considered the likely effects of the substance being unavailable in accordance with section
29(1) of the Act. I consider that, should this substance not be available, it could lead to lesser
consumer choice.
Benefit assessment (positive effects)
5.4. The applicant considers that the approval of Fodder Beet Smooth will provide the following benefits:
Fodder Beet Smooth is increases competition into the market which could lead to economic
benefits through more competitive pricing
Fodder Beet Smooth is formulated to maximise efficacy and to be easy to use and store
Fodder Beet Smooth is an effective herbicide which will control the broadleaf weeds listed on
the label. This will result in optimal herbicidal efficacy and therefore contribute to higher quality
produce.
5.5. I am satisfied that the availability of Fodder Beet Smooth will provide beneficial economic effects for
some businesses with the potential for flow-on effects to local communities and the New Zealand
economy, including improved customer choice and greater competition.
6. Variation of prescribed controls and cost-effectiveness
Modification of controls under section 77 of the Act
6.1. Section 77 of the Act allows the prescribed controls to be varied, substituted, added and/or deleted
where:
9
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
the adverse effects identified for a substance are different from those which would usually be
associated with substances with the same hazard classification
the adverse effects cannot be identified for a substance because of the scientific and technical
uncertainty in the available information, or
the benefits of the substance are retained without significantly increasing the adverse effects.
5.1 I have not made any other changes to the prescribed controls under section 77 of the Act.
Addition of controls under section 77A of the Act
6.2. Section 77A of the Act also allows the EPA to add, vary, substitute, combine or delete controls if such
changes are more effective or more cost-effective in terms of managing the use and risks of the
substance, or are more likely to achieve their purpose than the prescribed controls.
6.3. I have, therefore, added the following controls, as set out in Table 2:
Table 2: Additional controls and variations to existing controls
Control Justification
T7 This control restricts the carriage of toxic or corrosive substances on passenger service vehicles (e.g.
buses, trains). The existing maximum quantities of class 6.5 substances (0.1 L) have been reviewed
and an increased maximum quantity of 1 L has been implemented to ensure that any products available
in retail outlets can be carried on passenger service vehicles.
E1 Environmental Exposure Limit values (EEL) can be set to limit hazardous substances from entering the
environment in quantities sufficient to present a risk to it. No EEL values are set for any component of
Fodder Beet Smooth at this time as the risk of adverse effects to the environment has been assessed
as being negligible. The default EEL values are deleted. Consequently no application rate has been set
in E2.
I16 This control specifies the requirement for identifying the name and concentration of certain toxic
components on the product label and other documentation. Consistent with the guidance provided by
the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), this control has
been varied to include the revised concentration cut-offs that trigger the requirements for labelling the
relevant components present in this substance:
HSNO Classification Cut-off for label (% w/w) Cut-off for SDS (% w/w)
6.1A, B, C, D
Any % of component that would independently of any other component cause the product to classify
Any % that causes the product to classify
6.1E aspiration
Any % of component that would independently of any other component cause the product to classify
Any % of component that would independently of any other component cause the product to classify
8.2, 8.3 Any % that causes the product to classify
Any % that causes the product to classify
6.5A, 6.5B, 6.6A, 6.7A 0.1 0.1
6.6B 1 1
6.7B 1 0.1
6.8A, 6.8C 0.3 0.1
6.8B 3 0.1
6.9A, 6.9B 10 1
10
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Under these regulations, the name and concentration of the following components (or subcomponents)
need to be specified on the label and (M)SDS:
Labelling requirement (M)SDS requirement
6.1D: Metamitron
6.5B: Desmedipham
6.5B: Desmedipham
6.7B: Sub-component that
triggers this hazard
classification
6.9B:Desmedipham
6.9B: Phenmedipham
EM12 This control specifies the emergency management requirements for secondary containment of liquid
hazardous substances (or those likely to liquefy in a fire) and pooling substances. However, this control
does not allow for dispensation where it is unnecessary for any pipework associated with the stationary
container systems to have secondary containment. I have, therefore, varied the emergency
management controls to address this.
Water The environmental risk assessment indicates that restrictions on use and application of this substance
are necessary to mitigate the risk of adverse effects to humans and organisms in the environment.
Accordingly, I consider that the application of controls addressing these potential risks will be more
effective than the prescribed controls with respect to their effects on the management, application and
risks of this substance. Consequently, additional controls are applied to Fodder Beet Smooth to restrict
the level of risk to the aquatic environment.
Application
method
Restriction
on impurity
An active ingredient in Fodder Beet Smooth, ethofumesate, is associated with toxicologically significant
impurities. When present in high enough concentrations, such impurities can cause adverse effects to
people and the environment. Imposing a restriction on the maximum amount of impurities that can be
present in the active ingredient used to manufacture Fodder Beet Smooth will prevent the impurity from
occurring in concentrations sufficient to cause adverse effects to people or the environment.
Accordingly, I consider that the application of an additional control to address this concern will be more
effective than the prescribed controls with respect to its effect on the management, use and risks of the
substance. Consequently, an addition control is added to Fodder Beet Smooth and this control is
outlined in Appendix A.
Schedule 8 SCHEDULE 8 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS AND SCHEDULED
TOXIC SUBSTANCES) TRANSFER NOTICE 2004
The prescribed controls do not address the risks associated with storage or use of substances within
stationary container systems (e.g. tanks). These risks include the potential failure of primary
containment resulting in a large spill of the substance into the environment. The risk that this substance
will be stored in bulk without consideration of the equipment it is contained in, or the location of that
equipment, will need to be mitigated.
Accordingly, I have applied the requirements of Schedule 8 of the Hazardous Substances (Dangerous
Goods and Scheduled Toxic Substances) Transfer Notice 20042 (as amended) to this substance. I
consider that the application of controls addressing these risks are more effective than the prescribed
controls with respect to their effect on the management, use and risks of the substance and therefore
set them as a control (Sch 8) under section 77A of the Act, notwithstanding clause 1 of that schedule.
2 Available at http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf
11
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Assessment of control modifications
6.4. I consider that the modifications to the controls under section 77A of the Act fulfil the legislative criteria
of being, relative to the prescribed controls, either:
more effective with respect to their effect on the management, use, and risks of the substance,
or
more cost-effective in terms of their effect on the management, use, and risks of the
substance, or
more likely to achieve their purpose.
6.5. I have incorporated these controls into Appendix A of this document.
Exposure limits
6.6. Control T1 allows the EPA to set ADE (Acceptable daily exposure), PDE (Potential daily exposure)
and TEL (Tolerable exposure limit) values. I consider that exposure to this substance is not likely to
result in an appreciable toxic effect to people, and therefore the criteria for setting an ADE under
section 11(1)(c) of the Hazardous Substances (Classes 6, 8 and 9) Regulations 2001 was not met. As
a result, no ADE value has been set under control T1 at this time. As no ADE has been set then no
PDE or TEL is able to be set at this stage.
6.7. I have adopted Workspace Exposure Standards WES values as set by WorkSafe New Zealand for the
T2 control.3
6.8. Section 77B of the Act permits the EPA to set exposure limits for the substance or any element or
compound making up the substance. I have not set any exposure limits under section 77B of the Act
at this time.
Review of controls for cost-effectiveness
6.9. The proposed controls, provided they are complied with, are the most cost-effective means of
managing the identified potential risks associated with this substance. The applicant was provided an
opportunity to comment on the cost-effectiveness of the additional controls as set out in this decision
and no concerns were raised.
7. Risk assessment summary
7.1. I concluded that the residual level of risk of any adverse effects, after taking into account the
prescribed controls and any variations to these controls, is negligible, as summarised in Table 3.
3 Document DOL11590.4 FEB13 and any subsequent version approved or endorsed by the EPA. Version 7 is available at
http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-
indices/workplace-exposure-standards-and-biological-indices-2013.pdf
12
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Table 3: Summary of risk assessment
Potentially significant adverse effect Residual level of risk
On the environment Negligible
On human health and safety Negligible
On Māori culture and traditions Negligible
On the market economy Negligible
On society and the community Negligible
On New Zealand’s international obligations Negligible
8. Decision
8.1. Pursuant to section 29 of the Act, I have considered this application for approval made under section
28 of the Act. I have considered the effects of this substance throughout its life cycle, the controls that
may be imposed on this substance and the likely effects of this substance being unavailable.
8.2. I am satisfied with the hazard classifications identified by the staff in Table 1 and confer them
accordingly on Fodder Beet Smooth.
8.3. I have determined that the positive effects of this substance outweigh any adverse effects. Therefore,
the import or manufacture of Fodder Beet Smooth is approved with controls as listed in Appendix A.
Dr Allan L Freeth Date: 17 June 2016
Chief Executive, EPA
13
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Appendix A: Controls applying to Fodder Beet Smooth
Please refer to the Hazardous Substances Regulations4 for the requirements prescribed for each control.
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code Regulation Description Variation
T1 11 – 27 Limiting exposure to toxic substances
through the setting of environmental
values
No TEL values are set for any component
of this substance at this time
T2 29, 30 Controlling exposure in places of work
through the setting of WES values
The EPA adopts as WES values for this
substance, and each component of this
substance, any applicable value specified
in WorkSafe New Zealand’s Workplace
Exposure Standards and Biological
Exposure Indices Document; 7th Edition;
February 20135
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
The trigger level for this control is varied
from 0.1 L to 1 L.
E1 32 – 45 Limiting exposure to ecotoxic
substances through the setting of EEL
values
No EEL values are set at this time and
the default EEL values are deleted
E2 46 – 48 Restrictions on use of substances in
application areas
E5 5(2), 6 Requirements for keeping records of
use
E6 7 Requirements for equipment used to
handle substances
E7 9 Approved handler/security
requirements for certain ecotoxic
substances
Hazardous Substances (Identification) Regulations 2001
Code Regulation Description Variation
I1 6, 7, 32 – 35,
36(1) – (7)
Identification requirements, duties of
persons in charge, accessibility,
4 The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz
5 Or any subsequent version of this Standard approved or endorsed by the EPA.
14
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Code Regulation Description Variation
comprehensibility, clarity and
durability
I3 9 Priority identifiers for ecotoxic
substances
I8 14 Priority identifiers for toxic substances
I9 18 Secondary identifiers for all
hazardous substances
I11 20 Secondary identifiers for ecotoxic
substances
I16 25 Secondary identifiers for toxic
substances
The concentration cut-offs that trigger the
requirement for labelling of components
are set out in the following table:
HSNO Classification
Cut-off for label % (I16)
6.5A, 6.5B, 6.6A, 6.7A
0.1
6.6B 1
6.7B 1
6.8A, 6.8C 0.3
6.8B 3
6.9A, 6.9B 10
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
I20 36(8) Durability of information for class 6.1
substances
I21 37 – 39,
47 – 50
General documentation requirements
I23 41 Specific documentation requirements
for ecotoxic substances
I28 46 Specific documentation requirements
for toxic substances
I29 51, 52 Signage requirements
I30 53 Advertising corrosive and toxic
substances
15
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Hazardous Substances (Packaging) Regulations 2001
Code Regulation Description Variation
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
P15 21 Packaging requirements for ecotoxic
substances
PG3 Schedule 3 Packaging requirements equivalent to
UN Packing Group III
PS4 Schedule 4 Packaging requirements as specified
in Schedule 4
Hazardous Substances (Disposal) Regulations 2001
Code Regulation Description Variation
D4 8 Disposal requirements for toxic and
corrosive substances
D5 9 Disposal requirements for ecotoxic
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
Hazardous Substances (Emergency Management) Regulations 2001
Code Regulation Description Variation
EM1 6, 7, 9 – 11 Level 1 information requirements for
suppliers and persons in charge
EM6 8(e) Information requirements for toxic
substances
EM7 8(f) Information requirements for ecotoxic
substances
EM8 12 – 16, 18 –
20
Level 2 information requirements for
suppliers and persons in charge
16
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Code Regulation Description Variation
EM11 25 – 34 Level 3 emergency management
requirements: duties of person in
charge, emergency response plans
EM12 35 – 41 Level 3 emergency management
requirements: secondary containment
The following subclauses are added after
subclause (3) of regulation 36:
(4) For the purposes of this regulation, and
regulations 37 to 40, where this
substance is contained in pipework that
is installed and operated so as to
manage any loss of containment in the
pipework it—
(a) is not to be taken into account in
determining whether a place is
required to have a secondary
containment system; and
(b) is not required to be located in a
secondary containment system.
(5) In this clause, pipework—
(a) means piping that—
(i) is connected to a stationary
container; and
(ii) is used to transfer a hazardous
substance into or out of the
stationary container; and
(b) includes a process pipeline or a
transfer line.
The following subclauses are added at the
end of regulation 37:
(2) If pooling substances which do not have
class 1 to 5 hazard classifications are
held in a place above ground in
containers each of which has a capacity
of 60 litres or less—
(a) if the place’s total pooling potential
is less than 20,000 litres, the
secondary containment system
must have a capacity of at least
25% of that total pooling potential:
(b) if the place’s total pooling potential
is 20,000 litres or more, the
secondary containment system
must have a capacity of the
greater of—
(i) 5% of the total pooling
potential; or
17
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Code Regulation Description Variation
(ii) 5,000 litres.
(3) Pooling substances to which subclause
(2) applies must be segregated where
appropriate to ensure that leakage of
one substance may not adversely affect
the container of another substance.
The following subclauses are added at the
end of regulation 38:
(2) If pooling substances which do not have
class 1 to 5 hazard classifications are
held in a place above ground in
containers 1 or more of which have a
capacity of more than 60 litres but none
of which have a capacity of more than
450 litres—
(a) if the place’s total pooling potential
is less than 20,000 litres, the
secondary containment system
must have a capacity of either
25% of that total pooling potential
or 110% of the capacity of the
largest container, whichever is the
greater:
(b) if the place’s total pooling potential
is 20,000 litres or more, the
secondary containment system
must have a capacity of the
greater of—
(i) 5% of the total pooling potential;
or
(ii) 5,000 litres
(3) Pooling substances to which subclause
(2) applies must be segregated where
appropriate to ensure that the leakage of
one substance may not adversely affect
the container of another substance.
EM13 42 Level 3 emergency management
requirements: signage
Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001
Code Regulation Description Variation
AH 1 4 – 6 Approved Handler requirements
(including test certificate and
qualification requirements)
18
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Hazardous Substances (Tracking) Regulations 2001
Code Regulation Description Variation
TR1 4(1), 5, 6 General tracking requirements
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Code Regulation Description Variation
Tank
Wagon
4 – 43, as
applicable
Controls relating to tank wagons
and transportable containers
Additional controls
Code Section of
the Act Control
Water 77A This substance must not be applied into or onto water
Application
Method
This substance must be applied using ground-based methods only
Restriction
on impurity
The following limits are set for toxicologically relevant impurities in the active
ingredient ethofumesate used to manufacture this substance:
- ethyl methane sulfonate: 0.1 mg/kg maximum
- iso-butyl methane sulfonate: 0.1 mg/kg maximum
Stationary
Container
Systems
Schedule 8 SCHEDULE 8 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS
AND SCHEDULED TOXIC SUBSTANCES) TRANSFER NOTICE 2004
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/Transfer-
Notice-35-2004.pdf
The following clause replaces Clause 1 of Schedule 8 of the Hazardous Substances
(Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004:
This Schedule applies to every stationary container system that contains, or is
intended to contain the substance
19
Decision on application for approval to import or manufacture Fodder Beet Smooth for release (APP202824)
June 2016
Definitions
Unless defined below, terms used in the controls have the same meaning as defined in the Act or regulations
made under the Act.
Term Definition
Ground-based
application
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.
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.