DECISION - EPA · 2019. 4. 6. · Hempaguard X7 89909 (available in different colours) contains 9% copper pyrithione as the active ingredient, and is intended to be mixed with Hempel’s

DECISION

16 October 2017

Summary

Substances HEMPAGUARD X7 89909

Application code APP203090

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 Hempel (New Zealand) Ltd

Purpose of the application To import Hempaguard X7 89909, an antifouling paint with 9% copper

pyrithione as the active ingredient

Date application received 20 February 2017

Consideration date 27 September to 16 October 2017

Further information was requested from the applicant during the evaluation

of the application in accordance with section 58 of the Act. The

consideration was therefore postponed in line with section 59 of the Act.

Considered by The Chief Executive1 of the Environmental Protection Authority (“the EPA”)

Decision Approved with controls

Approval code HSR101255

Hazard classifications 3.1C, 6.1C, 6.3A, 6.5B, 6.7B, 6.8B, 6.9B, 8.3A, 9.1A

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 Hempaguard X7 89909 for release (APP203090)

October 2017

1. Substance

1.1. Hempaguard X7 89909 (available in different colours) contains 9% copper pyrithione as the active

ingredient, and is intended to be mixed with Hempel’s Crosslinker 98980 (in a specific ratio) to form a

ready-to-use antifouling formulation. This formulation is intended for professional use and is to be

applied by low-volume airless sprayer, and by brush and roller for smaller applications.

1.2. The applicant originally intended for Hempel’s Crosslinker 98980, a silicone-based binder, to be

considered in this application. Following discussions with the applicant, it was decided that Hempel’s

Crosslinker 98980 is more appropriate for regulation under a Group Standard. Therefore, only

Hempaguard X7 89909 is considered for approval in this application.

1.3. In 2013 the EPA reassessed antifouling paint formulations that were approved for use in New

Zealand. This led to the withdrawal of approvals for a number of substances, and the approvals for

several substances were made time-limited for a four or ten year period. The approvals for the other

antifouling paints were continued, but subject to additional controls, and this included substances with

the active ingredient (copper pyrithione) present in Hempaguard X7 89909. The considerations made

in APP201051 informed this decision on the application for the Hempaguard X7 89909.

2. Process and notification

Application receipt

2.1. The application was formally received on 20 February 2017 under section 28 of the Act. There were

unlikely to be significant public interest in this application so it was not publicly notified in accordance

with section 53(2) of the Act.

Information available for consideration

2.2. Further information was requested from the applicant during the evaluation phase in accordance with

section 58 of the Act. The consideration was therefore postponed in line with section 59 of the Act.

2.3. The information available is sufficient for assessing this application. This information includes the

application form, confidential appendices to the application and the EPA staff advice memorandum.

Notification to government departments

2.4. In accordance with section 53(4) of the Act, WorkSafe New Zealand was notified of this application

and invited to comment. No comments were received.

Legislative criteria for the application

2.5. The application was considered in accordance with section 29 of the Act. This took into account other

relevant sections of the Act, the Hazardous Substances Regulations and the Hazardous Substances

and New Organisms (Methodology) Order 1998.

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3. Hazardous properties, prescribed controls and exposure limits

Hazardous properties

3.1. The hazard classifications for Hempaguard X7 89909 (Table 1) were determined by the EPA using:

formulation-specific data submitted by the applicant

information on the effects of the individual components of Hempaguard X7 89909

mixture rules.

3.2. The applicant submitted formulation data on the flashpoint of Hempaguard X7 89909 and this was

used to assign the 3.1C classification.

3.3. The applicant submitted a mammalian, oral toxicity study for Hempaguard X7 89909, which showed

that the substance has an LD50 > 2000 mg/kg bw. Using this value the EPA determined that a 9.3

classification is not appropriate.

Table 1: Hazard classifications assigned to Hempaguard X7 89909

Hazard endpoint Hazard classifications

Flammable liquid 3.1C

Acute toxicity (oral) 6.1E

Acute toxicity (inhalation) 6.1C

Skin irritancy/corrosivity 6.3A

Eye irritancy/corrosivity 8.3A

Contact sensitisation 6.5B

Carcinogenicity 6.7B

Reproductive/ developmental toxicity 6.8B

Target organ or systemic toxicity (oral) 6.9B

Target organ or systemic toxicity (inhalation) 6.9B

Aquatic ecotoxicity 9.1A

Prescribed controls

3.4. The hazard classifications of Hempaguard X7 89909 determine a set of prescribed controls that is

specified by the Hazardous Substances Regulations under the Act. These prescribed controls set the

baseline for how this substance should be managed and include specifications on how the substance

is to be packaged, labelled, stored, disposed, transported, handled and used. The prescribed controls

form the basis of the final control set detailed in Appendix A.

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Exposure limits

3.5. Control T1 allows the EPA to set ADE (Acceptable Daily Exposure), PDE (Potential Daily Exposure)

and TEL (Tolerable Exposure Limit) values. No ADE value is set for any component of Hempaguard

X7 89909 at this time, as the risks of exposure to this substance is not likely to result in an appreciable

toxic effect to people, provided users comply with the controls in Appendix A. Therefore, the criterion

for setting an ADE value under regulation 11(1)(c) of the Hazardous Substances (Classes 6, 8 and 9)

Regulations 2001 is not met. As no ADE value has been set, then no PDE or TEL value is required to

be set.

3.6. Control T2 allows Workplace Exposure Standard (WES) values to be set for any component of a

substance to limit the exposure of people to toxic substances in places of work. The relevant WES

values listed in the WorkSafe New Zealand Standard Workplace Exposure Standards and Biological

Exposure Indices 8th Edition2, are adopted and applied. This applies for all relevant components of

this substance in accordance with regulation 30(1)(a) of the Hazardous Substances (Classes 6,8 and

9) Regulations 2001, where applicable.

3.7. Control E1 allows the EPA to set Environmental Exposure Limit (EEL) values. No EEL values are set

for any component of Hempaguard X7 89909 at this time, as the risk of adverse effects to the

environment can be adequately managed, provided users comply with the controls in Appendix A. The

default EEL values are deleted.

4. Risk and benefit assessment

Risk assessment

4.1. The risk assessment takes into account the hazardous properties of the substance, the prescribed

controls and other relevant legislation such as the Land Transport Rule 45001, Civil Aviation Act 1990

and Maritime Transport Act 1994.

4.2. The risk and benefit assessment:

considers the risks posed by Hempaguard X7 89909

determines whether any variations or additions to the prescribed controls are required to manage

the risks of this substance, and identifies controls that may be deleted.

determines whether the risks are outweighed by the benefits

Assessment of risks to human health

4.3. The human health risks have been assessed in accordance with Section 29(1) of the Act. This

assessment takes into account the full life cycle of the substance, which includes import and

manufacture, packaging, transport, storage, use and disposal.

2 Or any subsequent version of this Standard approved or endorsed by the EPA.

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4.4. A quantitative assessment of the risks posed by Hempaguard X7 89909 to human health was

undertaken by the EPA. Hempaguard X7 89909 contains copper pyrithione up to a concentration of

9%. This is higher than the concentrations of copper pyrithione in other antifouling paints approved

under the Act. Therefore, the risks posed by Hempaguard X7 89909 to human health and the

environment are likely to be different from the copper pyrithione-containing antifouling paints approved

under the Act.

4.5. The applicant provided the EPA with an operator risk assessment that assesses the risks of exposure

to people applying Hempaguard X7 89909 using airless spray equipment and paint brushes and

rollers. This risk assessment considers Hempaguard X7 89909 when it is mixed in an appropriate ratio

with Hempel’s Crosslinker 98980. The EPA has taken into account the available information, and has

found no evidence of synergistic effects when Hempaguard X7 89909 is mixed with Hempel’s

Crosslinker 98980.

4.6. The applicant also provided a study (in vitro percutaneous absorption following OECD 428) on the

dermal absorption of Hempaguard X7 89909. The EPA considers that this study is appropriate for

consideration.

4.7. The EPA reviewed the operator risk assessment and the dermal absorption study; and together with

its own risk assessment, determined that the risks posed by Hempaguard X7 89909 to users can be

mitigated to a negligible level. This is dependent on the use of appropriate personal protective

equipment (PPE) and respiratory protective equipment (RPE). Operators applying the substance with

an airless sprayer should wear protective gloves, double coveralls and RPE 40.

4.8. The EPA’s risk assessment concluded that the chronic risk to users applying the substance by brush

or roller is negligible. This chronic risk is negligible even without the use of PPE. However, prescribed

controls that are based on the acute hazards of Hempaguard X7 89909 (such as eye corrosivity), still

require the use of PPE, and these controls are retained on this approval.

4.9. The EPA’s risk assessment also concluded that full PPE and RPE with a protection factor of at least

10 (RPE 10) is required to reduce exposure risks to a negligible level for operators mixing and loading

the substance.

4.10. The risk posed by Hempaguard X7 89909 to human health is negligible, provided users comply with

the controls in Appendix A.

Assessment of risks to the environment

4.11. The environmental risks have been assessed in accordance with Section 29(1) of the Act. This

assessment takes into account the full life cycle of this substance. The full life cycle includes

importation and manufacture, packaging, transport, storage, use and disposal.

4.12. Antifouling paints are very toxic to the aquatic environment, with some paints also being toxic to the

terrestrial environment. However, the likelihood of a terrestrial environment being exposed to a

significant level of antifouling paint is considered unlikely given compliance with the HSNO controls,

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and so the environmental risk assessment for this substance focuses on the risks to the aquatic

environment.

4.13. The applicant provided the EPA with an environmental risk assessment. This assessment estimates

the Predicted Environmental Concentration (PEC) of copper pyrithione in a commercial New Zealand

harbour.

4.14. The EPA reviewed the applicant’s environmental risk assessment, and together with its own risk

assessment, determined that the risks posed by Hempaguard X7 89909 to environment is negligible.

This is dependent on compliance with the controls on Appendix A.

Assessment of risks to Māori and their relationship to the environment

Kupu arataki (Context)

4.15. The potential effects of Hempaguard X7 89909 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 this Act shall: Recognise and provide for the maintenance

and enhancement of people and communities to provide for their cultural well-being (section 5(b)), and;

take into account the relationship of Māori and their culture and traditions with their ancestral lands,

water, sites, wāhi tapu, valued flora and fauna, and other taonga (section 6(d)) and the principles of the

Treaty of Waitangi (section 8).

4.16. It is noted that Hempaguard X7 89909 triggers a number of hazardous properties giving rise to the

potential for cultural risk e.g. aquatic ecotoxicity. 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.

4.17. 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 water given the ecotoxic nature of Hempaguard X7 89909 to Te Marae o Tangaroa (marine

ecosystems), in particular species associated with mahinga kai (food resources), taputapu (tools and

equipment) and kōrero o mua (traditional narratives) as well as other cultural associations.

Ngā here whakapapa (Genealogical obligations)

4.18. Māori have a holistic and intergenerational view of the environment based around whakapapa

(genealogies) and whanaungatanga (relationships) connecting people and all things in the world, living

and non-living, animate and inanimate. Māori cultural beliefs and environmental frameworks use

kinship, personification and metaphor to explain the origins of, and interrelationships between, all

things. These beliefs and frameworks are maintained and transmitted to successive generations

through kōrero o mua (traditional narratives), mātauranga (knowledge systems) and tikanga

(customary values and practices).

4.19. According to Māori creation traditions, Tāne-mahuta (deity of humans, forests and forest-dwelling

species) procreated birds, insects, trees, plants and humans. As progeny of Tāne, all of these

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organisms share whakapapa (genealogy) with one another and are closely related. Since birds,

insects, trees and plants were created before humans, the former have tuākana (senior sibling) status

in relation to humans who are teina (junior siblings). This tuākana – teina relationship dictates that

careful consideration of potential risks and impacts on plants and animals and places a responsibility

on Māori commonly known as kaitiakitanga (guardianship, due care and diligence).

4.20. Fish and other aquatic species are descendants of Tangaroa (deity of the sea and water-dwelling

species). Many of Tangaroa’s descendants live in the domain of Maru (tutelary guardian of fresh

water). Again, whakapapa obliges us to ensure that the best interests of these related and

interconnected elements are taken care of.

4.21. Any use of, or effects on, organisms and natural resources need to be contemplated within this

fundamental construct. Compelling justification is required for any detrimental impacts.

Ngā tikanga tuku iho (Cultural legacies)

4.22. Hazardous substances that may potentially harm or adversely interfere with culturally significant

receptors are unacceptable to Māori. Any level of contamination of cultural receptors by hazardous

substances is undesirable – irrespective of the quantity of contaminants coming into contact with the

receptors, period of exposure, and the nature, scale and intensity of adverse effects.

4.23. 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.

4.24. Any substance that poses risk to the web of life, and the plants and creatures within it, is an issue for

Māori. The importance to Māori of ensuring that taonga species flourish cannot be overstated

historically or contemporarily. In former times, kai moana (seafood) was vital for sustaining Māori

communities and whānau. Estuarine and marine species of plants and animals formed a critical part of

the food supply. Taonga species remain essential for continuing customary practices and meeting

cultural obligations, especially in respect of showing manaaki (hospitality) to guests on the marae,

providing whānau with traditional kai, healing people using age-old remedies, and performing rituals in

accordance with proper method and material.

Te Marae o Tangaroa (Marine ecosystems)

4.25. Māori are connected to the sea by whakapapa and history; they came to Aotearoa from the ocean, and

believe that after death their spirit returns across this vast domain of Tangaroa to the ancient homeland

of Hawaiki to join ancestors of the distant past. Te Marae o Tangaroa was a life support system for

coastal Māori – it was important in terms of sustenance, raw materials, transport, trade, warfare, identity,

literature and technology. This deeply rooted association continues today, albeit in contemporary forms

and expressions. Māori would therefore be concerned about any potentially risk to taonga species posed

by Hempaguard X7 89909.

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4.26. Hempaguard X7 89909 has potential to harm or interfere with a wide range of culturally significant

species in coastal and marine environments. Potentially affected taonga food species include the

following inhabitants of estuaries, harbours and bays: Tio para (dredge oyster / Bluff oyster), tio repe

(rock oyster), tio o Te Moana-nui-a-Kiwa (pacific oyster), pāua (abalone), kuku (mussel), pipi / tuatua /

toheroa (wedge clams), tuangi (cockle), tipa (scallop), kina (sea urchin), tipa (scallop), pūpū (cat’s eye),

kanae (grey mullet), aua (yellow-eyed mullet), kahawai (sea trout), araara (trevally), tāmure (snapper),

haku (yellowtail kingfish), kumukumu (gurnard), red cod (hoka), rāwaru (blue cod), mararī (butterfish),

kōkiri (leatherjacket), ngōiro (conger eel), ihe (piper), hauture (jack mackerel), pioke (rig), whai

(stingray), octopus (wheke), various pātiki (flounders), various pāpaka (crabs), kōura (crayfish) and

karengo (southern laver). Some of these creatures are prey for other culturally significant species of

ika kanihi (predatory fish), mangō (sharks), manu wai tai (sea birds) and kekeno (seals).

4.27. Māori use the bones, teeth, shells and skins of marine species for ornaments, tools and other devices.

Matau (fish hooks) and pā (fishing lures) were fashioned from bone and pāua shell. Shells were used

to make necklaces, anklets, containers, musical instruments, inlays in carvings, as well as for cutting

hair, scaling fish and scraping flax leaves in the preparation of muka (flax fibre) for a variety of uses.

4.28. Rimurapa (bull kelp) was made into bags known as pōhā for preserving and storing tītī (mutton birds).

It was used to make flutes and was also roasted and chewed. Such is the importance of rimu

(seaweed) generally that rimurapa and karengo (southern laver) are protected under the Ngāi Tahu

Claims Settlement Act 1998 from commercial harvesting within Ngāi Tahu’s customary seaweed

gathering areas. Rimu features in waiata (songs). For instance, the waiata tangi (lament) ‘Rimu rimu,

tere tere’ uses the metaphor of seaweed floating in the sea to describe the feeling of drifting in a sea

of pain and sorrow following the loss of a loved one. The word ‘rimu’ derives from ‘limu’, a term used

for seaweed throughout the Pacific. The rimu tree was named after ‘sea rimu’ seaweed on account of

its foliage resembling its marine namesake, not the other way around.

4.29. Marine life is cherished by Māori for many reasons other than its instrumental value such as food and

raw materials for other uses. For example, Māori observe characteristics in species that they use for

describing or modelling human behaviour and attributes. These ‘model’ species are embedded in

whakataukī (proverbial sayings), for instance “Kia mate ururoa, kei mate wheke (Die like a shark, don’t

die like an octopus)”, which advocates perseverance and resilience. An octopus is fairly passive when

caught but sharks fight tenaciously to the end, so this whakataukī encourages people to not give up

and overcome difficulties no matter how hard the struggle. Another whakataukī, “E kore te patiki e hoki

ki tona puehu (The flounder does not return to the sediment cloud it stirs up)”, advises people to not

repeat mistakes and move on to other opportunities. That is, learn from experience and make the

most of opportunities that come one’s way.

4.30. Marine species play a central role in kōrero o mua (traditional narratives) concerning the origin and

discovery of New Zealand. For example, Māori legends inform us that the North Island came into

being when the demi-god and trickster Māui hauled up a gigantic fish from the depths of the ocean.

This fish, ‘Te Ika a Māui’ (The Fish of Māui) – the Māori name for the North Island, was a stingray.

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According to another tradition, Kupe’s pursuit of a giant octopus called ‘Te Wheke a Muturangi’

(Muturangi’s octopus) across the Pacific Ocean led him to discovering New Zealand. It was during this

mission that Kupe’s wife, Hine-te-Aparangi, named this land ‘Aotearoa’ (land of the long white cloud).

4.31. Sea creatures are valued in Māori art. Motifs of mangō (sharks), whai (stingrays), pātiki (flounder)

depicted in kōwhaiwhai patterns on rafters, and pātiki on tukutuku (lattice-work wall panels), inside

whare nui (meeting houses) and whare kai (dining halls) portray the relationships and importance of

these species to local Māori.

4.32. In addition to the above species, there are many others e.g. pātangaroa (starfish) and

koromāungaunga (barnacles) that Māori valued for their intrinsic qualities as part of the natural order

of ecosystem relationships within the domain of Tangaroa.

4.33. Hempaguard X7 89909 will have harmful or fatal effects on organisms attaching onto the hull of

vessels treated with this substance, as it is designed to prevent biofouling by repelling or killing such

organisms. These organisms are likely to be of such types or in stages of development that they are

unsuitable for consumption or use by humans irrespective of the ecotoxic action of ablative surfaces.

Hempaguard X7 89909 is unlikely to pose an appreciable threat to culturally significant species

moving through or inhabiting the general vicinity of vessels treated with this substance, as these are

less likely to come into direct contact with ablative surfaces than ‘attaching’ ones.

Taha hauora (Human health)

4.34. Hempaguard X7 89909 is classified as a skin and eye irritant / corrosive, and contact sensitiser. It is

also harmful to human organs or systems and is a suspected carcinogen as well as a suspected

human reproductive or developmental toxicant. Hempaguard X7 89909 is acutely toxic when ingested

or inhaled. For these reasons, Hempaguard X7 89909 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).

4.35. Exposure to Hempaguard X7 89909 may inhibit taha whānaunga – the responsibility to belong, care

for and share in the collective, including co-workers, relationships and workplace cohesion. There is a

risk that using this substance may compromise the ability to protect people 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.

4.36. The potential for reproductive impairment and its implications for whakapapa is a serious matter for

Māori. Whakapapa is sacrosanct; it is pervasive in Māori art, architecture, carving, rituals and

literature, and is the fundamental basis of the Māori cosmogeny. Human reproduction and

transmission of ‘ira tangata’ (human life) from one generation to the next is hugely important to Māori

in a symbolic as well as ordinary sense.

4.37. To interfere with reproductive capability is to disrespect the unbroken human and spiritual thread that

stretches back to the first human procreated by Tāne-mahuta (deity of humans, forests and forest-

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dwelling species) and Hineahuone (earth-formed woman). The phrase ‘tīhei mauriora’ (the sneeze of

life), a common idiom, refers to the sneeze that brought Hineahuone to life and rendered her capable

of giving birth to humankind and is used to connect people with their mortal and spiritual origins.

4.38. Similarly, tampering with human growth and development may impair mauri (life principle, vital

essence) and ability to fulfil potential that all people were imbued with when human beings were first

created. Good physical health is necessary for optimal growth and development.

4.39. Māori working with Hempaguard X7 89909 may potentially be a vulnerable group, as Māori have a

significantly higher registration rates than non-Māori for a range of diseases and medical conditions

relating to human organs including heart, lungs, liver and kidney.

Ētahi atu mea (Other matters)

4.40. Hempaguard X7 89909 is not anticipated to pose a threat to culturally significant species in the

domains of Te Marae o Tāne (terrestrial ecosytems) and Te Marae o Maru (freshwater ecosystems)

including those associated with mahinga kai (food resources), rongoā (medicine and healing), pūeru

(textiles), rauemi raranga (weaving materials), taputapu (tools and equipment), mahi toi (arts),

whakarākei (ornamentation) and ritenga (rituals).

4.41. Hempaguard X7 89909 is not likely to adversely affect culturally significant species of Te Aitanga

Pepeke (insects, arthropods), ngā kararehe (quadrupeds), ngā manu (birds), ngā ngārara (reptiles)

me ngā rīroi (rodents).

4.42. It is noted that Hempaguard X7 89909 would be applied to vessel hulls by appropriately trained

professionals in controlled work areas.

4.43. Māori participate in a wide range of economic and leisure activities based on marine vessels including,

commercial trawling, recreational fishing and diving, sightseeing and tourism ventures (e.g. whale-

watching). Using Hempaguard X7 89909 on vessels involved with these activities may help operators

to provide cheaper and better products, services and experiences for consumers. This may have a

positive effect on taha hauora, particularly in respect of taha wairua (spiritual health and well-being)

and taha hinengaro (mental and emotional well-being).

4.44. Using Hempaguard X7 89909 to control the accumulation of aquatic organisms on the hulls of vessels

will produce economic and/or operational benefits for those owning or operating vessels, some of

whom are Māori.

4.45. Hempaguard X7 89909 provides an option that vessel owners and operators can consider as an

alternative to other antifouling products that are currently available.

He whakangāwari me te whakamaru (Mitigation and protection)

4.46. The risks to human health can be mitigated by stipulating that those applying the substance to vessels

should have approved handler status and use appropriate PPE e.g. double full body overalls, chemical

resistant gloves, covered safety footwear and full mask respiratory protection.

https://en.wikipedia.org/wiki/Biofouling

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4.47. Limiting use of Hempaguard X7 89909 to controlled work areas including restricted entry should avoid

inadvertently exposing bystanders to this substance, in particular vulnerable groups such as tamariki

(children), kaumātua (the elderly), ngā tūroro (the unwell) me ngā kūware (the unknowing or unaware).

4.48. Controls requiring appropriate collection and disposal of washdown wastewater and residual waste

arising from surface preparation of vessel hulls can minimise potential for off-target site contamination.

4.49. Potential risk to taonga species cannot be avoided or mitigated.

Manaakitanga (Due care)

4.50. Manaakitanga is about valuing people, acting with goodwill and beneficial purpose, showing respect,

caring for and protecting the well-being of people and the environment. Manaakitanga extends to

physical, spiritual, social and economic well-being – which can manifest in dimensions of taha hauora

(human health). Mitigation measures are available for managing risks associated with Hempaguard X7

89909 in relation to taha hauora. Keeping people safe and protecting the well-being of those operating

vessels or enjoying services and experiences based on vessels treated with Hempaguard X7 89909 is

consistent with the practice of manaakitanga.

Kupu whakatepe (Conclusion)

4.51. Based on the information provided, including the use pattern and the controls proposed to be assigned

to Hempaguard X7 89909, the overall potential risk to Māori interests is likely to be acceptable in

terms of Māori cultural beliefs and environmental frameworks.

The HSNO Act

Section 5(b) – recognise and provide for cultural well-being

4.52. This application is not likely to put overall cultural well-being of Māori at risk in terms of their cultural

beliefs and environmental frameworks.

Section 6(d) – take into account Māori relationship to the environment

4.53. The EPA’s cultural risk assessment considers potential risks and impacts on Māori interests including

the relationship of Māori to the environment, culturally significant species and resources, and

mātauranga (knowledge systems) and the tikanga (customary values and practices) associated with

these taonga. It has identified cultural concerns in relation to human health and marine organisms in

particular taonga food species. While the human health aspects can be avoided or mitigated, the

adverse effects on taonga species cannot. However, on balance the risks and benefits to Māori

interests are likely to be acceptable and align as a whole with Māori cultural beliefs and environmental

frameworks.

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Section 8 – take into account Treaty of Waitangi principles

The active protection principle i.e. the Crown has a duty to actively protect Māori interests.

4.54. The EPA has undertaken a cultural risk assessment to consider potential risks and impacts on Māori

interests as well as controls and mitigation measures for protecting Māori interests. As noted above,

the human health issues can be mitigated but the potential effects on taonga species cannot.

However, on balance the risks and benefits to Māori interests are likely to be acceptable and align as

a whole with Māori cultural beliefs and environmental frameworks.

The taonga principle i.e. ‘taonga’ include all valued resources and intangible cultural assets.

4.55. The scope of the EPA’s cultural risk assessment includes tangible and intangible taonga, such as

culturally significant species and resources, mātauranga (knowledge systems) and the tikanga

(customary values and practices) associated with these taonga.

Assessment of risks to society, the community and the market economy

4.56. No risks to society, communities or the market economy were identified from a release approval for

the importation or manufacture of Hempaguard X7 89909.

New Zealand’s international obligations

4.57. No international obligations were identified as being impacted by a release approval for the

importation or manufacture of Hempaguard X7 89909.

The effects of the substance being unavailable

4.58. The likely effects of the substance being unavailable was considered in accordance with section 29(1)

of the Act. It is considered that, should this substance not be available, it could lead to less consumer

choice.

Assessment of benefits

4.59. The antifouling paints reassessment (APP201051) determined that there are benefits to the use of

antifouling paints, which includes their use as a biosecurity tool to help prevent the spread of

unwanted organisms in New Zealand waters.

4.60. Another benefit identified for antifouling paints in APP201051 is that they provide cost and efficiency

benefits to vessel operators, as biological growth attached to hull surfaces create increased frictional

resistance which slows vessels down. By avoiding this, benefits are realised in terms of time spent

travelling, and the amount of fuel consumed.

4.61. In addition, benefits specific to copper were identified in APP201051. Copper is the main biocide used

in antifouling paints and is responsible for the majority of the paint’s efficacy and for the generic

benefits identified above.

4.62. The generic benefits identified above, are considered relevant to Hempaguard X7 89909. The EPA is

also satisfied that the availability of Hempaguard X7 89909 will provide beneficial economic effects for

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October 2017

some businesses with the potential for flow-on effects to local communities and the New Zealand

economy, including improved consumer choice and greater market competition.

4.63. The applicant considers that a benefit of Hempaguard X7 89909 is that the product releases less

biocide to the aquatic environment, relative to other antifouling paints.

5. Variation of the prescribed controls

Modification of controls under section 77A of the Act

5.1. 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.

5.2. It is necessary to vary or delete some of the prescribed controls and impose additional controls on the

approval for Hempaguard X7 89909. The relevant justifications for modifying the controls are outlined

in Table 2.

Table 2: Justification for the additional controls and variation/deletion of the prescribed controls

Control Justification

R-2

R-3

R-4

R-5

Antifouling paints controls

The antifouling paints reassessment (APP201051) imposed four additional controls (R-2 to

R-5) on all antifouling paints approved under the Act. These additional controls are applied to

the approval for Hempaguard X7 89909.

T5 Requirement for protective clothing and equipment

The prescribed controls include requirements in regulation 8 of Hazardous Substances

(Classes 6, 8, and 9 Controls) Regulations 2001 that people handling Hempaguard X7 89909

use protective clothing or equipment that prevents them from coming into contact with, or

inhaling the substance. This control is varied in accordance with APP201051 to better

manage the risks of human exposure to Hempaguard X7 89909.

This control will apply to any person applying or removing Hempaguard X7 89909, including

in locations that are not designated as workplaces.

I21-23, I25,

I28

EM8-9

D8

Requirement for safety data sheet

The outcome of APP201051 imposed an additional control (R-5), which specifies that safety

data sheets are to be supplied with antifouling paints. R-5 replaces the requirements of

prescribed controls I21, I22, I23, I25, I28, EM8, EM9 and D8; consequently, these controls

are deleted.

T6

E7

AH1

Approved handler/security requirements

The risks posed by Hempaguard X7 89909 to people and the environment can be adequately

mitigated without an approved handler requirement. A similar conclusion was made in the

antifouling paints reassessment (APP201051). Therefore, controls T6, E7 and AH1 are

deleted.

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Control Justification

TR1 Requirement for tracking

This control relates to tracking requirements and has been triggered by certain toxic and

ecotoxic properties of Hempaguard X7 89909. This control is varied to limit the tracking

requirements up to the point of sale to allow non-professional users to use this substance.

The risks that may arise after the point of retail sale of this substance are adequately

managed through other controls.

The risk assessment for Hempaguard X7 89909 did not identify any additional risk if the

substance is used in a non-professional setting, provided the controls in Appendix A are

complied with.

Use Control Requirement for use restriction

The risk assessment for Hempaguard X7 89909 is based on its use as an antifouling paint.

This is a key factor in preventing harmful exposures of people and the environment to the

substance. It is therefore necessary to apply a use control that restricts Hempaguard X7

89909 for use only as an antifouling paint.

EM12 Requirement for secondary containment

This control is varied to note that any quantities of the substance contained within pipework

are not required to be taken into account when determining whether a place is required to

have a secondary containment system.

The prescribed control specifies the emergency management requirements for secondary

containment of liquid hazardous substances (or those likely to liquefy in a fire). However, it

does not allow for dispensation where it is unnecessary for any pipework associated with the

stationary container systems to have secondary containment.

Schedules 8,

9, and 10

Stationary containers, secondary containment and unintended ignition requirements

The requirements of Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous Goods

and Schedules Toxic Substances) Transfer Notice 2004 are applied to the approval for

Hempaguard X7 89909. These controls are considered to be more effective as the

prescribed controls do not address the risks associated with storage or use of Hempaguard

X7 89909 within stationary container systems (e.g. tanks). In addition, the prescribed controls

do not address all the risks associated with the secondary containment and unintended

ignition of Hempaguard X7 89909.

Assessment of control modifications

5.3. The modifications to the controls fulfil the legislative criteria under section 77A(4)(a) of the Act, as

relative to the prescribed controls, they are more effective with respect to their effect on the

management, use, and risks of the substance.

Review of controls for cost-effectiveness

5.4. The proposed controls, provided they are complied with, are the most cost-effective means of

managing the potential risks associated with Hempaguard X7 89909. The applicant was provided an

opportunity to comment on the cost-effectiveness. The applicant did not raise any concerns.

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6. Decision

6.1. Pursuant to section 29 of the Act, I have considered this application for approval 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.

6.2. I consider that, with controls in place, the risks to human health and to the environment are negligible,

and the benefits associated with the release of this substance will outweigh the adverse effects.

6.3. Hempaguard X7 89909 is approved for release with the controls in Appendix A, in accordance with

section 29 of the Act and clause 26 of the Hazardous Substances and New Organisms (Methodology)

Order 1998.

Dr Allan L Freeth Date: 16 October 2017

Chief Executive, EPA

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Appendix A: Controls applying to Hempaguard X7 89909

Please refer to the Hazardous Substances Regulations3 for the requirements prescribed for each control.

Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001

Code Regulation Description Variation

F1 7 General test certification

requirements for hazardous

substance locations

F2 8 Restrictions on the carriage of

flammable substances on passenger

service vehicles

F3 55 General limits on flammable

substances

F5 58, 59 Requirements regarding hazardous

atmosphere zones for class 2.1.1,

2.1.2 and 3.1 substances

F6 60 – 70 Requirements to prevent unintended

ignition of class 2.1.1, 2.1.2 and 3.1

substances

F11 76 Segregation of incompatible

substances

F12 77 Requirement to establish a

hazardous substance locations if

flammable substances are present

F14 81 Test certification requirements for

facilities where class 2.1.1, 2.1.2 or

3.1 substances are present

F16 83 Controls on transit depots where

flammable substances are present

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001


T1 11 – 27 Limiting exposure to toxic substances

through the setting of ADE, PDE or

TEL values

No ADE, PDE or 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

3 The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz

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

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Exposure Standards and Biological

Exposure Indices Document; 8th Edition4

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

Subclause (1) of Reg. 8 of the Hazardous

Substances (Classes 6, 8, and 9

Controls) Regulations 2001 is replaced

by the following:

(1) Any person who handles the

substance must use protective

clothing or equipment that is

designed, constructed, and operated

to ensure that the person

(a) does not come into contact with

or inhale, the substance; and

(b) is not exposed to a

concentration of the substance

that exceeds the workplace

exposure standard (WES) for

that substance, if a WES for

that substance exists.

T7 10 Restrictions on the carriage of toxic or

corrosive substances on passenger

service vehicles

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

Hazardous Substances (Identification) Regulations 2001


I1 6, 7, 32 – 35,

36(1) – (7)

Identification requirements, duties of

persons in charge, accessibility,

4 Or any subsequent version of this Standard approved or endorsed by the EPA.

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comprehensibility, clarity and

durability

I2 8 Priority identifiers for corrosive

substances

I3 9 Priority identifiers for ecotoxic

substances

I5 11 Priority identifiers for flammable

substances

I8 14 Priority identifiers for toxic substances

I9 18 Secondary identifiers for all

hazardous substances

I10 19 Secondary identifiers for corrosive

substances

I11 20 Secondary identifiers for ecotoxic

substances

I13 22 Secondary identifiers for flammable

substances

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

I20 36(8) Durability of information for class 6.1

substances

I29 51, 52 Signage requirements

I30 53 Advertising corrosive and toxic

substances

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

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P5 11 Packaging requirements for

flammable liquids

P13 19 Packaging requirements for toxic

substances

P14 20 Packaging requirements for corrosive

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


D2 6 Disposal requirements for flammable

substances

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

Hazardous Substances (Emergency Management) Regulations 2001


EM1 6, 7, 9 – 11 Level 1 information requirements for

suppliers and persons in charge

EM2 8(a) Information requirements for corrosive

substances

EM6 8(e) Information requirements for toxic

substances

EM7 8(f) Information requirements for ecotoxic

substances

EM10 21 – 24 Fire extinguisher requirements

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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.

EM13 42 Level 3 emergency management

requirements: signage

Hazardous Substances (Tracking) Regulations 2001


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

Subclause (1) of regulation 4 is deleted and

substituted with the following subclause:

(1) The location and movement of every

tracked substances must be recorded at each

stage of its lifecycle up until, and including,

the point of retail sale, in accordance with

these regulations.

Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004


Tank

Wagon

4 – 43, as

applicable

Controls relating to tank wagons

and transportable containers

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Controls added under section 77A of the Act

Code Control

Use restriction No person may use this substance for any purpose other than as an antifouling

paint to prevent, by the slow release of biocides, the build-up of aquatic

organisms on the hulls of vessels or other surfaces in contact with water.

Schedules 8, 9

and 10

The controls relating to stationary container systems, secondary containment

and unintended ignition of flammable substances, as set out in schedules 8, 9

and 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic

Substances) Transfer Notice 20045 (Supplement to the New Zealand Gazette, 26

March 2004, No 35, page 767), as amended, shall apply to this substance,

notwithstanding clause 1(1) of Schedules 8 and 9 and clause 1 of Schedule 10.

R-2 Controlled work area and signage

(1) Any person applying the substance must ensure that application of the

substance is carried out in a controlled work area.

(2) The controlled work area, as referred to in subclause (1) is a designated

area in which antifouling paints are applied, using a method and located

such that off-target deposition of the substance, including onto bystanders,

is avoided by taking all practicable steps.

(3) Any person applying the substance in a controlled work area must avoid

off-target deposition of the substance. To avoid doubt, this requirement

includes avoiding off-target deposition of the substance onto persons

outside of, but within the immediate vicinity of, the controlled work area.

Signage

(4) Any person applying the substance must ensure that signs are placed at

every point of entrance into the controlled work area. Signs must be posted

from the start of application, until the end of the application.

(5) Signs erected in accordance with (4) must—

(a) warn that an application is being carried out using a substance that is

toxic to humans;

(b) identify the person in charge of the application;

(c) state that entry into the controlled work area is not permitted unless

personal protective equipment (PPE) is worn by the person entering

the controlled work area; and

(d) comply with regulation 34 and regulation 35 of the Hazardous

Substances (Identification) Regulations 2001 as if the distance

referred to in regulation 35(3) is not less than 10 metres.

R-3 Collection of substances from maintenance activities

(1) Any person who removes any antifouling paint coating from the hull of a

boat must ensure that waste containing antifouling paint residue is

collected; and

(2) All collected waste, as referred to in subclause (1), must be disposed of in

accordance with the Hazardous Substances (Disposal) Regulations 2001.

5 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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Code Control

R-4

Additional labelling requirements

For formulated antifouling substances:

(1) Labels must include the following statements (or similar):

(a) When applying this substance by spraying, you must sufficiently

enclose the area to ensure that the substance is not deposited on off-

target sites and has no adverse effects on bystanders

(b) You must ensure that waste generated from maintenance activities

does not enter the environment

(2) A person must not supply a hazardous substance to any other person

unless the substance label shows the information required by (1).

R-5 Safety Data Sheets

(1) A person, when selling or supplying this substance at any quantity, must

provide a safety data sheet for the substance to the recipient if—

(a) the substance is likely to be used in a place of work; and

(b) they have not previously supplied a safety data sheet for that

substance to the recipient

(2) In each place of work where the substance is manufactured, stored, or

used, the person in charge of the place must ensure that every person

handling the substance has access to a safety data sheet for that

substance.

(3) The safety data sheet must be available to a person handling the substance

within 10 minutes, and be readily understandable by any fully trained

persons required to have access to it.

(4) A person who manufactures or supplies a substance in New Zealand, or

imports a substance into New Zealand must, if asked to do so by any

person in charge of a place of work where a substance is stored or used,

give that person the required safety data sheet.

(5) Information required on a safety data sheet must be provided under the

following 16 general headings in the order listed below, and must include

the information referred to under those headings:

Section 1 - Identification of the substance and supplier—

(i) product name

(ii) recommended uses

(iii) name of the supplier, New Zealand contact details including an

emergency contact.

Section 2 - Hazards identification—

(i) a description of the hazards of the substance, which may include its

HSNO hazard classification

(ii) hazard information, including signal words, hazard statement(s) and

precautionary statement(s).

Section 3 - Composition/information on ingredients—

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October 2017

Code Control

(i) in the case of single component substances, their chemical identity,

including common names and synonyms, CAS number and any

impurities that are themselves hazardous

(ii) in the case of substances that are mixtures, the chemical identity of

each hazardous ingredient, their CAS number and their concentration

ranges.

Section 4 - First aid measures—

(i) first aid instructions according to each relevant route of exposure

(ii) whether medical attention is required, and its urgency

(iii) information on the most important symptoms and effects, acute and

delayed, from exposure.

Section 5 - Fire fighting measures—

(i) information on the appropriate type of extinguishers or fire-fighting

agents, including extinguishers that may not be appropriate for a

particular situation

(ii) any advice on hazards that may arise from combustion products

(iii) precautions for fire fighters and protective clothing requirements.

Section 6 - Accidental release measures—

(i) advice on protective clothing requirements and emergency

procedures

(ii) any environmental precautions from accidental spills and release

(iii) advice on how to contain and clean up a spill or release;

Section 7 - Handling and storage—

(i) precautions for safe handling

(ii) conditions for safe storage, including any incompatibilities.

Section 8 - Exposure controls/personal protection—

(i) exposure limits set for the substance or any of its components, or in

their absence, relevant overseas exposure limits

(ii) engineering controls

(iii) individual protection measures, including personal protective

equipment.

Section 9 - Physical and chemical properties—

(i) a description of relevant physical and chemical properties for the

substance, including units of measurement and reference conditions

where appropriate

(ii) where necessary for interpretation of data reported, the method of

determination.

Section 10 - Stability and reactivity—

(i) an indication of the chemical stability of the substance under normal

and anticipated storage and handling conditions

(ii) a list of conditions to avoid to prevent a hazardous situation; and

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October 2017

Code Control

(iii) information on incompatible substances or materials.

Section 11 - Toxicological information—

(i) a full description of the toxicological (health) effects, including the

symptoms or signs of injury or ill health associated with each likely

route of exposure

(ii) the dose, concentration or conditions of exposure likely to cause injury

or ill health

(iii) a summary of the data used to identify the health effects.

Section 12 - Ecological information—

(i) ecotoxicity

(ii) persistence and degradability

(iii) mobility.

Section 13 - Disposal considerations—

(i) disposal methods, including disposal of packaging

(ii) special precautions to be taken during disposal

(iii) any method of disposal that should not be used.

Section 14 - Transport information—

If relevant,

(i) the UN number

(ii) the proper shipping name

(iii) the UN Dangerous Goods class and subsidiary risk

(iv) the UN Packing Group.

Section 15 - Regulatory information—

(i) HSNO approval number

(ii) information on any other regulatory requirements such as the

controlled work area and signage requirements.

Section 16 - Other information—

(i) date of preparation or revision of the safety data sheet

(ii) a key/legend to abbreviations and acronyms used.

(6) Where a substance is being transported, a safety data sheet is not required

if—

(a) there is in the vehicle concerned documentation complying with the

Land Transport Rule whilst being transported by land; or

(b) there is in the ship concerned documentation complying with the

Maritime Rule whilst being transported by sea; or

(c) there is in the aircraft concerned documentation complying with the

Civil Aviation Rule whilst being transported by air.

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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

RPE 40 e.g. full face mask EN 136 and P3 filter; powered hood, helmet or blouse model TH3 EN 146/EN

12941; power-assisted full face mask model TM3 EN 147/EN 12942.

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.

Documents

DECISION - EPA · 2019. 4. 6. · Hempaguard X7 89909 (available in different colours) contains 9% copper pyrithione as the active ingredient, and is intended to be mixed with Hempel’s