decision - epa.govt.nz · 2 decision on application for approval to import or manufacture fabula...

DECISION

21 April 2016

Summary

Substance Fabula

Application code APP202755

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 Adria New Zealand Limited

Purpose of the application To import Fabula, a herbicide containing 480 g/litre sulfentrazone in

the form of a suspension concentrate, to control a range of weeds in

pumpkin, buttercup squash and potatoes

Date application received 8 March 2016

Consideration date 21 April 2016

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

EPA”)

Decision Approved with controls

Approval code HSR101129

Hazard classifications 6.3B, 6.4A, 6.8B, 6.9B (oral), 9.1A, 9.2A

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 Fabula for release (APP202755)

1. Substance

1.1. Fabula is a suspension concentrate containing 480 g/L sulfentrazone as the active ingredient. It is

intended to be used by professional users to control a range of weeds in crops such as pumpkin,

buttercup squash, and potatoes.

1.2. The applicant intends to import Fabula into New Zealand fully formulated, packaged and labelled

ready for sale in 500 mL and 1 L HDPE containers.

2. Process and notification

Application receipt

2.1. The application was formally received on 8 March 2016 under section 28 of the Act.

Information available for consideration

2.2. The information available for the consideration comprises:

the application form,

confidential appendices to the application,

the EPA Kaupapa Kura Taiao Māori advice memorandum, and

the EPA science advice memorandum.

2.3. I consider that I have sufficient information to assess the application.

Public notification

2.4. Fabula contains an active ingredient that is used in similar ways in other approved substances.

Accordingly, 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. In line with section 53(4) of the Act, the following government departments were notified of the

application on 9 March 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 Fabula 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 to those submitted by the

applicant (Table 1). These differences have arisen due to new information on a component of the

formulation, and to a review of the interpretation of the mixture rules for this substance.

Table 1: Hazard classifications of Fabula

Hazard Applicant classification EPA classification

Acute toxicity (oral) 6.1D -

Skin irritancy 6.3B 6.3B

Eye irritancy 6.4A 6.4A

Contact sensitisation 6.5B -

Reproductive/ developmental toxicity 6.8B 6.8B

Target organ or systemic toxicity 6.9B (oral) 6.9B (oral)

Aquatic ecotoxicity 9.1A 9.1A

Soil ecotoxicity 9.2A 9.2A

4. Risk and benefit assessment

Prescribed controls

4.1. The hazard classifications of Fabula determine a set of prescribed controls as specified by the

Hazardous Substances Regulations under the Act.

4.2. These prescribed controls form the basis of the controls detailed in Appendix A and set the baseline

for how the substance should be managed throughout its lifecycle in New Zealand.

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. This assessment:

considers the risks posed by Fabula,

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 are not applicable or necessary

that can therefore be deleted.

Assessment of risks to human health and the environment

4.5. I have evaluated the potential of Fabula to cause adverse effects to people and/or the environment

during every lifecycle stage of the substance. The identification and qualitative assessment of the risks

arising from the human health and environmental hazards associated with Fabula are set out in

Appendix B.

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4.6. In addition, I note that Fabula contains the same active ingredient as other herbicides that are already

approved. Based on the application rates, proposed use-pattern and the prescribed controls that are

triggered by the hazard classifications of Fabula, the risks to human health are not likely to be

significantly higher from the use of Fabula compared to these other approved substances.

4.7. The use pattern of Fabula is such that there is potential for an environmental exposure to occur.

However, I note that similar products with a similar use pattern are already approved for use, and that

controls are applied to these products which mitigate these risks. I consider that any potential

ecological risks associated with the use of Fabula can be sufficiently mitigated by the application of

similar controls.

Assessment of risks to Māori and their relationship to the environment

Kupu arataki (context)

4.8. The potential effect of Fabula on the relationship of Māori to the environment has 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, and 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 (Tiriti o Waitangi).

4.9. I note that Fabula triggers several hazardous properties that give rise to the potential for cultural risk

e.g. aquatic ecotoxicity and suspected reproductive or developmental toxicity. Cultural risk includes

any negative impacts to taonga species, the environment, and the general health and well-being of

individuals and the community. In addition, the introduction and use of hazardous substances has the

potential to inhibit the ability of Māori to fulfil their role as kaitiaki.

Taha hauora (human health)

4.10. I note that Fabula is classified as a skin and eye irritant, is harmful to human organs or systems and is

a suspected human reproductive or developmental toxicant. For these reasons, Fabula poses risks to

taha hauora, in particular 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 (life principle, vital essence)).

4.11. If not adequately managed, I note that the potential for reproductive impairment may lead to impacts

on whakapapa, which is sacrosanct and which pervades Māori art forms and is fundamental to Māori

cosmogeny. Furthermore, the potential for Fabula to affect reproductive capability is of concern as this

has the potential to disrespect the connection between Māori and their mortal and spiritual origins.

Mahinga kai, rongoā me pūeru (food resources, medicine and textiles)

4.12. Fabula is classified as a soil ecotoxicant and therefore has the potential to cause adverse effects to

culturally significant plants used for food, medicine and weaving, such as pūhā and harakeke. I note

that such effects are only possible if taonga species are exposed to Fabula, for example through spray

drift onto adjoining land, and that the controls applied to Fabula will mitigate these risks.

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Pūkohu wai (algae)

4.13. Fabula is ecotoxic in aquatic environments and therefore has the potential to cause adverse effects to

pūkohu wai (freshwater algae). These organisms are valuable to Māori due to their role in water

purification and as a food source for small organisms and fish, which are in turn prey species for

culturally significant food species. I consider that these risks are mitigated by the suite of controls

proposed for Fabula, which include prohibiting application into or onto water.

Ngā one (soil)

4.14. I note that Fabula is very ecotoxic to soil environments and is therefore of concern to Māori due to the

potential effects on Papatūānuku (earth mother), who is considered the source of all living things and

is integral to Māori creation stories and to whenua (land) and ngā one.

Ētahi atu mea (other matters)

4.15. The intended use of Fabula to control a range of weeds in pumpkin, buttercup squash and potatoes

will produce economic benefits for those growing or working with these crops, some of whom are

Māori.

Kupu whakatepe (conclusion)

4.16. Based on the information provided, including the use pattern and the suite of controls proposed for

Fabula, I consider that the potential risks to Māori culture or traditional relationships with the

environment will be adequately mitigated, and that there are potential benefits to Māori that arise from

the use of Fabula.

4.17. If Fabula is used 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.

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

4.18 I have not identified any risks to society, communities or the market economy from the approval of

Fabula.

New Zealand’s international obligations

4.19 I have not identified any international obligations that may be impacted by the approval of Fabula.

The effects of the substance being unavailable

4.20 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 would lead to less consumer

choice.

Benefit assessment

4.21 The applicant considers that the approval of Fabula will provide the following benefits:

Highly effective control of weeds in pumpkins, buttercup squash, and potatoes leading to

higher crop yields.

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Low toxicity to humans and non-target species, and minimal environmental impact when used

as directed.

4.22 I am satisfied that the availability of Fabula will provide beneficial economic effects for some

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

such as increased customer choice and greater competition.

5. Variation and cost-effectiveness of prescribed controls

Modification of controls under section 77 of the Act

5.1. Section 77 of the Act allows the EPA to substitute, add or delete prescribed controls under certain

conditions. No modifications to the prescribed controls for Fabula have been made under section 77 of

the Act.

Addition and variation of controls under section 77A of the Act

5.2. Section 77A of the Act allows the EPA to add, vary, substitute, combine or delete specified 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.

5.3. I have, therefore varied the prescribed controls as set out in Table 2, and added controls as set out in

Table 3.

Table 2: Justification for variations to the prescribed controls (see Appendix A for control variations)

Control(s) Justification

E1, E2 Limiting exposure to ecotoxic substances through the setting of EEL values, and

restrictions on use of substances in application areas.

An Environmental Exposure Limit (EEL) can be set to limit a hazardous substance from

entering the environment in quantities sufficient to present a risk to it. I have not set an EEL for

any component of Fabula at this time as I consider that, at present, setting a maximum

application rate is more likely to achieve the intended purpose of this control.

T1 Limiting exposure to toxic substances through the setting of TEL, ADE and PDE values

Acceptable Daily Exposure (ADE), Potential Daily Exposure (PDE) and Tolerable Exposure

Limit (TEL) values can be set to limit the amount of a hazardous substance in the environment

to a level below that which presents a risk to human health. I consider that it is not necessary

to set these limits at this time as the risks to human health are adequately managed by other

controls.

I16 Identification and information requirements

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. I have outlined

this control in full in Appendix A.

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Under these regulations, the name and concentration of the following component(s) need(s) to

be specified on the label and (M)SDS:

Labelling requirement (M)SDS requirement

Sulfentrazone – 6.8B, 6.9B Sulfentrazone – 6.8B, 6.9B

Ethylene glycol – 6.9B

EM12 Emergency management requirements

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, as I consider that this

variation is more likely to achieve the intended purpose of the control.

I consider that the risks associated with the containment of substances which are not class 1 to

5 substances (i.e. do not ignite or explode) are different to those associated with class 1 to 5

substances. Consequently, the secondary containment requirements can be reduced. I

consider that these reduced secondary containment measures are adequate to manage the

risks of a spillage of Fabula, as this substance does not ignite or explode. Therefore, the

proposed variation is more cost-effective in terms of managing the risks of the substance.

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Table 3: Justification for addition of controls (see Appendix A for additional controls)


Water

Application

method

Application

rate

I consider that the risk assessment requires additional restrictions on use and application of this

substance are necessary to mitigate the risk of adverse effects 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, the following additional controls are applied to Fabula to restrict the level of

risk to the environment:

This substance must not be applied into or onto water.

This substance must be applied using ground-based methods only.

This substance must not be applied at rates exceeding 470 mL of formulated product/ha per application

(equivalent to 225.6 g sulfentrazone/ha) and must not be applied to the same area more than once per

year.

Label The prohibition of application of this substance onto or into water, the restriction to ground-based

application and the maximum application rate are key requirements to mitigate the potential

environmental risks associated with the use of Fabula. I consider it important for these requirements to

be stated on the product label and safety data sheet to ensure they are clearly communicated to users

of the substance, and that this variation is more effective in terms of its effect on the management, use

and risks of the substance. Therefore I have conferred these requirements on Fabula as an additional

control under section 77A of the Act.

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. It is therefore necessary to

mitigate against 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.

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 specified

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.

Review of controls for cost-effectiveness

5.1 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 additional controls as set out in this decision and no concerns were

raised.

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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6. Risk and benefit assessment summary

6.1. I conclude that the residual level of risk of any potential adverse effects, after taking into account the

prescribed controls and any variations to these controls, is negligible.

6.2. I consider that there are non-negligible benefits associated with the use of Fabula.

7. Decision

7.1 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 lifecycle, the controls that

may be imposed on this substance and the likely effects of this substance being unavailable.

7.2 I have determined that the positive effects of this substance outweigh any adverse effects. Therefore,

the import or manufacture of Fabula is approved with controls as listed in Appendix A.

Mark Patchett Date: 21 April 2016

Acting Chief Executive, EPA

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Appendix A: Controls applying to Fabula

Please refer to the Hazardous Substances Regulations3 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 TEL, ADE and

PDE values

No TEL, ADE or PDE 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 20134

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

E1 32 – 45 Limiting exposure to ecotoxic

substances through the setting of EEL

values

No EEL values are set at this time

E2 46 – 48 Restrictions on use of substances in

application areas

See additional controls set under s77A

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,

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

4 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

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

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

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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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

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

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that is installed and operated so as to

manage any loss of containment in the

pipework it—

(a) is not to be taken into account in

determining whether a place is

required to have a secondary

containment system; and

(b) is not required to be located in a

secondary containment system.

(5) In this clause, pipework—

(a) means piping that—

(i) is connected to a stationary

container; and

(ii) is used to transfer a

hazardous substance into or

out of the stationary

container; and

(b) includes a process pipeline or a

transfer line.

The following subclauses are added at the

end of regulation 37:

(2) If pooling substances which do not

have class 1 to 5 hazard classifications

are held in a place above ground in

containers each of which has a

capacity of 60 litres or less—

(a) if the place’s total pooling

potential is less than 20,000

litres, the secondary containment

system must have a capacity of

at least 25% of that total pooling

potential:

(b) if the place’s total pooling

potential is 20,000 litres or more,

the secondary containment


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 leakage of one substance

may not adversely affect the container

of another substance.

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The following subclauses are added at the

end of regulation 38:

(2) If pooling substances which do not

have class 1 to 5 hazard classifications

are held in a place above ground in

containers 1 or more of which have a

capacity of more than 60 litres but

none of which have a capacity of more

than 450 litres—

(a) if the place’s total pooling

potential is less than 20,000

litres, the secondary containment


either 25% of that total pooling

potential or 110% of the capacity

of the largest container,

whichever is the greater:

(b) if the place’s total pooling

potential is 20,000 litres or more,

the secondary containment


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)

Hazardous Substances (Tracking) Regulations 2001


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

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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.

Application

rate

The maximum application rate of this substance is 470 mL of formulated product/ha

(equivalent to 225.6 g of sulfentrazone/ha).

This substance must not be applied to the same area more than once per calendar

year.

Label The following statements, or words to the same effect, must be included on the

product label and safety data sheet (including the relevant definitions):

This substance must not be applied into or onto water.

The application of this substance is limited to ground-based application

methods only.

This substance must not be applied at rates exceeding 470 mL of

formulated product/ha per application (equivalent to 225.6 g

sulfentrazone/ha) and must not be applied to the same area more than

once per year.

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

a.i Active ingredient - the biologically active chemical in a pesticide product

Ground-based

methods

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

Where ‘water’ means water in all its physical forms, whether flowing or not, and whether over or

under ground, but does not include water in any form while in a pipe, tank or cistern or water used in

the dilution of the substance prior to application.

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Appendix B: Risk assessment

To facilitate the risk assessment, I have identified the most common potential sources of risk to human

health and the environment through release, spillage or exposure throughout the life cycle of the substance.

These are shown in Table B1. The process by which the risk assessment of hazardous substances is

undertaken is specified in the Methodology5. Guidance on risk assessment is provided on the EPA website6.

Table B1: Potential sources of risks associated with hazardous substances

Life cycle stage Associated source of risk

Manufacture* / Import An incident during the manufacture or importation of the substance resulting in a spill and

subsequent exposure of people or the environment to the substance.

Packing An incident during the packing of the substance resulting in a spill and subsequent

exposure of people or the environment to the substance.

Transport or storage An incident during the transport or storage of the substance resulting in a spill and

subsequent exposure of people or the environment to the substance.

Use Application of the substance resulting in exposure of users or bystanders or the

environment; or an incident during use resulting in a spill and subsequent exposure of

users or the environment to the substance.

Disposal Disposal of the substance or packaging resulting in exposure of people or the

environment to the substance.

* Although the applicant intends to import (not manufacture) Fabula, it is possible that this substance could be manufactured in New

Zealand in the future. Consequently, the risks associated with the manufacture of Fabula have also been evaluated

A summary of the qualitative risk assessment is given in Tables B2 and B3 below.

5 http://www.legislation.co.nz/regulation/public/1998/0217/latest/DLM254556.html?src=qs

6 http://www.epa.govt.nz/Publications/ER-TG-05-02_03_09_Decision_Making.pdf

http://www.legislation.co.nz/regulation/public/1998/0217/latest/DLM254556.html?src=qs

http://www.epa.govt.nz/Publications/ER-TG-05-02_03_09_Decision_Making.pdf

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Table B2: Qualitative risk assessment of biological hazards to human health

Life cycle Biological hazard Likelihood Magnitude Level of

risk

according

to matrix

Comments Residual

level of

risk

Manufacture

and packaging

Skin and eye irritancy

Very unlikely

Minimal

Negligible

The applicant does not currently intend to manufacture Fabula in

New Zealand. However, I note that should this occur,

manufacturing and packaging in New Zealand will be required to

meet the HSNO requirements for equipment, emergency

management and Personal Protective Equipment (PPE). The need

for compliance with HSNO information provisions for the constituent

components (e.g. labels, Safety Data Sheets) and WorkSafe New

Zealand’s Health and Safety requirements will also apply.

This means that workers handling this substance will need to be

aware of its hazards and the measures that need to be undertaken

to ensure their own safety. Provided that these measures are

taken, the level of risk is negligible.

Negligible

Reproductive or

developmental toxicity

Very unlikely

Moderate Low While the qualitative descriptors indicate a low level of risk driven

by the major chronic effects of Fabula, I note that if Fabula is

manufactured and packaged in New Zealand, this will be required

to meet the HSNO requirements for equipment, PPE, emergency

management and provision of information, as well as WorkSafe

New Zealand’s Health and Safety regulations. These requirements

will make the likelihood of exposure that would lead to an adverse

effect highly improbable, such that the level of risk for these

adverse effects is negligible.

Negligible

Target organ or system

toxicity

Very unlikely

Major Low Negligible

Importation,

transport,

storage

Skin and eye irritancy

Highly

improbable

Minimal

Negligible

Workers and bystanders will only be exposed to the substance

during this stage of the life cycle in isolated incidents if spillage

occurs, therefore only risks from acute exposure are considered for

these life cycle phases. Compliance with HSNO controls (e.g.

packaging, labels, SDS) and adherence to the Land Transport Rule

45001, Civil Aviation Act 1990 and Maritime Transport Act 1994, as

Negligible

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applicable, is required and will minimise the likelihood of a spill and

accordingly mitigate the risk of these adverse effects.

Use

(application)

Skin and eye irritancy Unlikely Minimal Negligible The substance will be labelled to identify its potential risks,

minimising the opportunity for it to cause adverse effects. HSNO

requirements for PPE, packaging, identification and emergency

management must be complied with. In conjunction with the

requirement for this substance to be under the control of an

approved handler (due to its ecotoxicity) these controls will mitigate

risks to human health. I also note that bystanders are not expected

to come into contact with the substance as it is intended for

commercial use.

Negligible

Reproductive or


Very unlikely Moderate Low Negligible


toxicity

Very unlikely Major Low Negligible

Disposal

Skin and eye irritancy Very unlikely Minimal Negligible The applicant intends for this substance to be used completely (i.e.

until the container is emptied), or alternately for excess product to

be returned to the supplier. Empty containers will be triple rinsed,

with the rinsate added to the spray tank, before the containers are

returned to an AgRecovery site for disposal. Disposal of the

substance and its used containers in New Zealand, if required,

must be in accordance with the requirements of the Hazardous

Substances (Disposal) Regulations 2001. Compliance with these

will reduce the opportunity for individuals to be exposed.

Negligible

Reproductive or


Highly

improbable

Moderate Negligible Negligible


toxicity

Highly

improbable

Major Low Negligible

20


Table B3: Qualitative assessment of biological hazards to the environment

Life cycle Biological hazard Likelihood Magnitude Level of

risk

according

to Matrix

Comment Residual

level of

risk

Manufacture,

importation,

transport and

storage

Death or adverse effects to

aquatic or terrestrial

organisms

Highly

improbable

Minor Negligible Provided that the exercise of this approval is in compliance with the

HSNO controls (and the Land Transport Rule 45001, Civil Aviation Act

1990 and Maritime Transport Act 1994 (as applicable)), the likelihood

of a spill leading to adverse effects is considered to be highly

improbable.

Negligible

Use

(application)


aquatic organisms

Unlikely Minor Low I consider that the use of appropriate statements on labels and Safety

Data Sheets prohibiting the application of this substance onto or into

water, the requirement for ground-based application only, the

maximum application rate and compliance with the approved handler

requirements will adequately manage the risks to the aquatic

environment.

Negligible


terrestrial organisms (e.g.

soil bacteria, plants)

Likely Minor Low I note that there is potential for localised environmental impact to occur

in that soil organisms within the application site may be affected by the

application of Fabula. I consider that the maximum application rate,

compliance with the approved handler requirements, and the

requirement for these to be listed on the product documentation will

adequately minimise risks to the soil environment.

Negligible

Disposal Death or adverse effects to

aquatic or terrestrial

organisms

Highly

improbable

Minor Negligible Users will, in most cases, utilise all of this substance by its intended

use as a herbicide. All cases of disposal are required to be in

accordance with the requirements of the Hazardous Substances

(Disposal) Regulations 2001.

Negligible

21


decision - epa.govt.nz · 2 decision on application for approval to import or manufacture fabula...

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