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.

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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.

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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

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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).

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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

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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.

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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:

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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



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

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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

http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf

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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

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

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

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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

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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


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.

http://www.legislation.co.nz/

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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

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Hazardous Substances (Packaging) Regulations 2001


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


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


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

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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


must have a capacity of the

greater of—

(i) 5% of the total pooling

potential; or

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(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


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


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


AH 1 4 – 6 Approved Handler requirements

(including test certificate and

qualification requirements)

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Hazardous Substances (Tracking) Regulations 2001


TR1 4(1), 5, 6 General tracking requirements

Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004


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



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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.

decision - epa · 6/17/2016 · 4.20. aquatic plants offer a habitat and protection for small fish...

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