decision - epa...flufenacet and metribuzin interact with each other or that their combination...

DECISION

23 May 2019

Amended under s67A on 12 June 2019

Summary

Substance Artist

Application code APP203344

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 Bayer New Zealand Limited

Purpose of the application To import Artist, a pre-emergence selective herbicide containing 240

g/kg flufenacet and 175 g/kg metribuzin in the form of a water

dispersible granule for the control of annual weeds in potatoes

Date application formally received 18 December 2017

Consideration date 22 – 23 May 2019

Further information was requested from the applicant during the

evaluation and review of the application in accordance with section 52

of the Act and the consideration was 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 HSR101359

Hazard classifications 6.1D (oral), 6.1E (dermal), 6.1D (inhalation), 6.5B, 6.9B (oral and

inhalation), 9.1A, 9.2A, 9.3C

1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.

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Decision on application for approval to import or manufacture Artist for release (APP203344)

JUNE/ 2019

1. Substance

1.1. Artist is a water dispersible granule herbicide containing 175 g/kg of metribuzin and 240 g/kg of

flufenacet as the active ingredients. It is intended to be imported and used by professional users to

control various weeds in potatoes. Artist is intended to be applied using ground-based boom

application methods.

1.2. Both active ingredients in Artist are approved for use in New Zealand but their combination is new and

the application rate of flufenacet is higher than in other substances, therefore human and ecological

quantitative risk assessments were conducted.

2. Process and consultation

Application receipt

2.1. The application was formally received on 18 December 2017 under section 28 of the Act.

Information available for consideration

2.2. The information available for the consideration comprised:

the application form

the confidential appendices to the application

the science memorandum.

2.3. Further information was requested from the applicant in accordance with section 52 of the Act.

2.4. With the further information received from the applicant, it is considered that there is sufficient

information to assess this application.

Public notification

2.5. 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

2.6. The following government departments were notified of the application on 19 December 2017: the

Ministry for Primary Industries (Agricultural Compounds and Veterinary Medicines Group) and the

Department of Conservation. No comments were received.

2.7. As the agency responsible for overseeing the Health and Safety at Work (HSW) Act and Regulations,

WorkSafe New Zealand (“WorkSafe”) has responsibility for assessing that the HSW requirements are

adequate to manage the risks from the substance. WorkSafe was notified of the application under

section 53(4) on 19 December 2017 and provided with the appropriate documents to allow them to

make this assessment. The comments from WorkSafe are summarised in Section 4 of this document.

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Legislative criteria for the application

2.8. The application was considered under section 29 of the Act, taking into account other relevant

sections of the Act, the EPA Notices, the HSW Act, the HSW (Hazardous Substances) Regulations

and the Hazardous Substances and New Organisms (Methodology) Order 1998.

3. Hazardous properties of Artist

3.1. The hazard classifications of Artist were determined based on the information provided by the

applicant (including toxicity and ecotoxicity studies), information on the individual components of Artist,

mixture rules and other available information (reports from overseas regulatory agencies).

3.2. The classifications that have been applied to Artist are different to those submitted by the applicant

(Table 1). The difference in classifications has arisen due to different interpretations of the study

submitted for the dermal toxicity classification and the misinterpretation of the mixture classification

rules by the applicant for toxicity via the inhalation route and ecotoxicity to soil organisms.

Table 1: Hazard classifications of Artist

Hazard Applicant classification EPA classification

Acute toxicity (oral) 6.1D 6.1D

Acute toxicity (dermal) No 6.1E

Acute toxicity (inhalation) ND* 6.1D

Contact sensitisation 6.5B 6.5B

Target organ or systemic toxicity (oral and

inhalation) 6.9B 6.9B

Aquatic ecotoxicity 9.1B 9.1A

Soil ecotoxicity No 9.2A

Terrestrial vertebrate ecotoxicity 9.3C 9.3C

* ND: Not Determined

4. Risk and benefit assessment

Risk assessment

4.1. The risk assessment has taken into account the hazardous properties of the substance, the

considerations in Part 2 of the Act, the prescribed controls under the Act and the requirements under

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

and Maritime Transport Act 1994.

4.2. The human health and 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, including import and

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

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4.3. The EPA staff determined that there is a potential for significant exposures to people and the

environment during the use phase of Artist.

4.4. Although the active ingredients in Artist are already approved individually in New Zealand via other

substances, a quantitative risk assessment was conducted because the combination of the two active

ingredients was new and the use pattern has a higher application rate than the already existing

formulations already on the market in New Zealand.

4.5. The risk and benefit assessment:

considered the risks posed by Artist,

determined whether the risks are outweighed by the benefits,

determined whether any variations, additions to or deletion of the prescribed controls are

required to manage the risks of the substance.

Assessment of risks to human health

4.6. Artist is intended to be supplied to the professional market. Users are expected to dilute the substance

in water and apply the substance using high volume broadcast/ground-based boom spraying

equipment. It is likely that users will be exposed to the substance during the mixing, loading and

application stages of the substance.

4.7. The potential risks posed by Artist to human health were assessed by estimating the exposure of

operators, re-entry workers and bystanders to the active ingredients, metribuzin and flufenacet. The

risks from exposure to metribuzin and flufenacet are considered as the main contributors to the hazard

properties of Artist.

4.8. To assess the risks posed by the substance to human health, the estimated exposure to each active

ingredient for the application on potatoes was compared to an Acceptable Operator Exposure Limit

(AOEL) value for each active ingredient and a risk quotient (RQ) is calculated. The AOEL used for

metribuzin is 0.02 mg/kg bw/day and an AOEL value of 0.017 mg/kg bw/day is used for flufenacet.

4.9. RQ values greater than one (RQ>1) indicate that exposure to the substance could result in significant

adverse effects, and that risk mitigating controls should be considered. RQ values less than one

(RQ

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4.11. No exposure from re-entry activity is expected because Artist is used as a pre-emergence herbicide,

therefore contact with foliar residues is very unlikely. Therefore, no restricted entry interval is

necessary.

4.12. The estimated risks to bystanders are also below the level of concern and no buffer zones are

proposed to mitigate risks to human health.

4.13. Artist is also a contact sensitizer (6.5B), any long term effects would require multiple exposures to this

substance over a time period which is unlikely. It is considered that the likelihood of significant

exposure would be reduced by the prescribed requirements under the HSW (HS) Regulations to use

PPE to minimise risks to the health and safety of workers, and by the prescribed controls under the

Act to provide information on the label and safety data sheet for Artist. As such, the risk from the

contact sensitisation hazard is assessed as being negligible.

4.14. With these controls and requirements in place, the overall level of risk to human health during the use

phase of Artist is considered negligible.

Assessment of risks to human health from workplace activities

4.15. WorkSafe was notified of the application and has provided the following comment on whether the

HSW requirements manage the risk to people from workplace activities.

4.16. WorkSafe has assessed the available information of APP203344 and considers that compliance with

the HSW and General Risk and Workplace Management Regulations will be adequate to reduce the

risks associated with the use of this substance in the workplace. While the regulations cover standard

risk mitigation measures, occupational exposure in the workplace needs to be assessed at each site

and appropriate controls put in place to mitigate the identified risks.

4.17. WorkSafe notes that a number of the new herbicide products approved in New Zealand in the last 5

years do not have human health hazards. Under Sections 39 - 42 of the HSW Act 2015,

manufacturers/importers/suppliers have a duty to ensure substances manufactured, imported or

supplied are without risk so far as is reasonably practicable. Applicants should be mindful of their

duties under the Health and Safety at Work Act 2015 when they apply for approval of new substances.

4.18. When using substances that have human health risks the PCBU must minimise the risks so far as

reasonably practicable by applying the hierarchy of controls set out in regulation 6 of the General Risk

and Workplace Management Regulations 2016. Personal protective equipment (PPE) may need to be

used or worn to minimise health risks, but should only be used as a control measure to eliminate risk

when other control measures alone cannot adequately do so. PPE should not be the first or only

control considered and WorkSafe expects PCBUs to give preference to other controls that protect

multiple at-risk workers at once.

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Assessment of risks to the environment

4.19. The potential risks posed by Artist to aquatic and terrestrial environments were assessed for the use

pattern proposed by the applicant. The EPA evaluated this use pattern and performed quantitative

modelling to determine the predicted environmental exposures.

Aquatic ecotoxicity (9.1A)

4.20. It was determined that the risks from the formulation with the two active ingredients could be estimated

from the results obtained in tests with “pure” active ingredients because there is no evidence that

flufenacet and metribuzin interact with each other or that their combination increases the toxicity

compared to the effects expected with each individual active ingredient.

4.21. Metribuzin and flufenacet are not rapidly degradable in the aquatic environment and are considered

persistent in aquatic environment (DT50 > 16 days) but are not bioaccumulative.

4.22. The metabolites of both active ingredients were less toxic than the parents for the endpoints used in

the risk assessment, therefore the metabolites were not included in the risk assessment.

4.23. The main potential source for aquatic organisms to be exposed to Artist is by spray drift during

application and surface water runoff after the substance is applied.

4.24. The predicted acute exposures to flufenacet and to metribuzin from spray drift and runoff were above

the level of concern for algae and aquatic plants. Therefore, further modelling was performed to

determine the buffer zones necessary to mitigate the risks to algae and aquatic plants from spray drift

and runoff.

4.25. The modelling, which took into account the intended method of application, determined that the risks

to aquatic plants from runoff could be managed by buffer zones. The buffer zone to protect water

bodies from runoff is 15 metres. The buffer zone to protect waterbodies from spray drift is 5 metres,

therefore the buffer zones to mitigate risks from runoff will also mitigate risks from spray drift.

4.26. An additional label control is also proposed to alert the users of situations where runoff is likely.

4.27. As the size of the buffer zone was calculated based on the specific application scenario requested by

the applicant, restrictions on application methods as well as a maximum application rate and

application frequency have also been set as controls when using this substance. In particular, the

application method is restricted to low boom, the minimum droplet size is restricted from medium to

coarse and the maximum application rate to 2.5 kg of Artist per hectare (equivalent to 600 g/ha of

flufenacet and 437.5 g/ha of metribuzin), with a maximum of one application per calendar year.

4.28. A risk of potential groundwater contamination by flufenacet that could affect groundwater community

was identified by the model. This risk could not be mitigated, but its effects are expected to be low.

4.29. No risk assessment could be performed for sediment-dwelling organisms due to a lack of data.

Therefore, the precautionary approach would consider that there is a potential low risk to sediment-

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dwelling organisms. However, with the application restrictions and buffer zones in place, this risk is

considered to be negligible.

4.30. With the buffer zones, application restrictions and other prescribed controls, the residual risks to the

aquatic environment are assessed as being negligible.

Toxicity to soil environment (9.2A)

4.31. Metribuzin is rapidly degradable in the soil environment but flufenacet is not and is therefore

considered persistent (DT50 > 28 days).

4.32. No acute risks were identified for earthworms, but no data were available to assess chronic risks; this

is a significant data gap because flufenacet is considered persistent in soil.

4.33. Risks to non-threatened and threatened non-target plants were identified, but could be mitigated with

downwind 5 metre buffer zones. Therefore, with controls in place, risks to non-target plants are

negligible.

Toxicity to terrestrial vertebrates (9.3C)

4.34. Risks above the level of concern were identified at the screening and first tier assessments for birds.

After further refinement, acute and chronic risks were estimated to be below the level of concern for

non-threatened species, and exposure was considered unlikely for threatened species. Therefore the

risks to birds are considered negligible.

Cultural Assessment

4.35. Kaupapa Kura Taiao (The EPA’s Māori Policy and Operations team) has undertaken a cultural

assessment to consider potential impacts of the application on the economic, social, and cultural well-

being of Māori, and the relationship of Māori with the environment, pursuant to sections 5(b), 6(d) and

8 of the HSNO Act. The cultural assessment includes tangible and intangible taonga, such as

culturally significant species, resources, and places, and the customary values, practices and uses

associated with these taonga. Key findings of the assessment are outlined below.

Impact on the relationship of Māori and their culture and traditions with their environment and

taonga

4.36. This application is not likely to significantly affect the relationship of Maori and their culture and

traditions with their environment and taonga, including culturally significant species, resources, and

places, and the customary values, practices and uses associated with these taonga.

Impact on the maintenance and enhancement of the capacity of people and communities to

provide for their own economic, social and cultural well-being




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Treaty of Waitangi principles

4.38. The Principles of the Treaty of Waitangi have been considered in relation to this application, as

summarised below.

4.39. The active protection principle: the Crown has a duty to actively protect Māori interests. No issues

arise.

4.40. The informed decision making principle: the Crown has a duty to make informed decisions. No issues

arise.

4.41. The partnership principle: to act fairly, reasonably, and in good faith. No issues arise..

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

4.42. No risks to society, communities or the market economy from the approval of Artist have been

identified.

New Zealand’s international obligations

4.43. No international obligations that may be impacted by the approval of Artist have been identified.

The effects of the substance being unavailable

4.44. The likely effects of Artist being unavailable in accordance with section 29(1) of the Act have been

considered. Should Artist not be available, it could lead to less consumer choice.

Assessment of benefits

4.45. The applicant considers that the approval of Artist will provide the following benefits:

Increased choice for farmers

Broader range of weeds controlled

Less resistance because of the combination of two active ingredients

4.46. There are currently 12 active ingredients registered for use as herbicides on potatoes (bentazone,

clomazone, cyanazine, fluazifop-P-butyl, linuron, methabenzthiazuron, metribuzin, prometryn,

quizalofop-P-ethyl, sulfentrazone, terbuthylazine, terbutryn), used in 38 formulated products.

4.47. There are currently ten registered products with metribuzin and two with flufenacet as the active

ingredients on ACVM. None of the registered products combine the two active ingredients and none of

the two products with flufenacet are used on potatoes.

4.48. The products containing metribuzin claim to control the following weeds: amaranthus, barnyard grass,

charlock, chickweed, fat hen, field speedwell, fumitory, galinsoga, groundsel, henbit, nettle, plantain,

redroot, scentless chamomile, shepherds purse, spurrey, small-flowered buttercups, stinking

mayweed, storks bill, twin cress, white campion, wild radish, wild turnip, willow weed, wireweed. They

also control these moderately susceptible weeds: cornbind, sow thistle, seedling docks, seedling

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Californian thistle, summer grasses. These products do not control: black nightshade, cleaver, dock,

giant buttercup, most deep-rooting weeds and most weeds over 4 leaf stage.

4.49. The products containing flufenacet claim to control the following weeds: brassicas, chickweed,

cleaver, field pansy, field madder, hedge mustard, mouse-ear chickweed, rayless chamomile,

scentless chamomile, seedling dock, shepherd's purse, sow thistle, speedwell, spurrey, storks bill,

vetch, annual poa and vulpia hair grass.

4.50. Artist is proposed to control the following weeds: yarrow, fat hen, fumitory, cleaver, narrow leaf

plantain, clover, field pansy, perennial ryegrass and black nightshade (moderately susceptible).

Therefore, Artist is claimed to control six weeds not controlled by currently approved products

containing only one of the two active ingredients in Artist (yarrow, cleaver, clover, field pansy,

perennial ryegrass and black nightshade). This is considered a significant benefit.

4.51. Although the benefits identified above were not verified by the EPA, it is considered that the availability

of Artist will provide beneficial economic effects for some businesses with the potential for flow-on

effects to local communities and the New Zealand economy, including improved consumer choice and

greater market competition.

5. Prescribed controls

5.1. The hazard classifications of Artist determine a set of prescribed controls, specified by the EPA

Notices2 under section 77 of the Act. There are also requirements in the HSW (HS) Regulations. Note:

the HSW (HS) requirements are not set for the substance under this approval but apply in their own

right.

5.2. The prescribed controls set the baseline for how the substance must be managed and include

specifications on how the substance is to be packaged, labelled, stored, disposed, transported,

handled and used. The prescribed controls also set information requirements (eg Safety Data Sheets),

signage and emergency management. These controls form the basis of the controls specified in

Appendix A.

Exposure limits

5.3. Under s77B of the Act, the EPA may set a Tolerable Exposure Limit (TEL) and/or an Environmental

Exposure Limit (EEL) for a substance with toxic or ecotoxic properties.

Regulation 13.17 of the HSW (HS) Regulations prohibits the use of a class 6 substance in

excess of a TEL.

Clause 49 of the Hazardous Property Controls Notice prohibits use of a class 9 substance in

excess of an EEL.

2 There may also be default controls in regulations made under the Act for certain hazardous substances such as fireworks.

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5.4. The EPA had provided ADE (Acceptable Daily Exposure) and PDE (Potential Daily Exposure) values

for flufenacet but not for metribuzin. These values have been updated for flufenacet and provided for

metribuzin.

5.5. It is considered that the following values are suitable for flufenacet:

ADE = 0.005 mg/kg bw/day

PDE(food) = 0.0035 mg/kg bw/day

PDE(drinking water) = 0.001 mg/kg bw/day

PDE(other) = 0.0005

5.6. It is considered that the following values are suitable for metribuzin:




PDE(other) = 0.0015

Acute reference dose (ARfD) = 0.02 mg/kg bw/day

5.7. The ADE and PDE shown above are proposed by the EPA as health-based exposure guidance values

that can be used to inform risk assessments as well as the setting of controls, such as Maximum

Residue Levels under the Agricultural Compounds and Veterinary Medicines Act 1997.

5.8. However, the EPA has not set a TEL for Artist, or any element or compound in the substance, as

exposure to this substance is not likely to result in an appreciable toxic effect to people, provided

controls on use are followed.

5.9. EEL values for water and soil have been set previously for metribuzin but not for flufenacet. However,

EELs are not applicable to Artist because the level of risk of adverse effects to the environment has

been qualitatively assessed as being negligible, with controls in place.

5.10. There are Workplace Exposure Standard (WES) values currently set for components of Artist but, as

they are not Prescribed Exposure Standard (PES) values, they are guidance values used for the

management of health risk. No PES has been set for any component of Artist.

5.11. Clause 17 of the Labelling Notice requires that certain toxic or corrosive components are identified on

the product label. Section 3 of Schedule 1 of the Safety Data Sheet (SDS) Notice requires certain toxic

or corrosive components are identified on the SDS. Section 8 of Schedule 1 of the SDS Notice

requires occupational exposure limits to be identified on the SDS, and Section 15 requires TEL and

EEL to be identified on the SDS. One component of Artist has a Workplace Exposure Value (WES).

5.12. The name and concentration of the following components need to be specified on the label and SDS

(Table 2):

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Table 2 List of components requiring identification

Label SDS

Metribuzin (6.1D, 6.9B) Metribuzin (6.1D, 6.9B, 9.1A)

Flufenacet (6.5B, 6.9B) Flufenacet (6.5B, 6.9B, 9.1A)

Kaolin (WES)

6. Changes to prescribed controls

6.1. The following modifications to the EPA Notice controls apply to Artist, as set out in Table 2:

Table 2: Justification for section 77 changes to the prescribed controls (see Appendix A for control

wordings)

Control Justification

Buffer zone

HPC Notice

Clause 51

HPC Clause 51 allows the EPA to set buffer zone distances as an additional control for a class 9

substance. Buffer zone distances are necessary to mitigate the risks to waterbodies from runoff

and spray drift. Clause 25 of the Labelling Notice requires buffer zones and associated relevant

application methods to be stated on the label.

Application

restrictions

HPC Notice

Clause 50

Significant environmental risks may occur from the use of this substance, due to the hazards

posed by flufenacet and metribuzin, the active ingredients in Artist. Therefore, it is considered

necessary to set a maximum application rate, number of applications and frequency under

clause 50 of the HPC Notice.

6.2. The following additional HSNO controls apply to Artist under section 77A of the Act, as set out in Table

3:

Table 3: Justification for the section 77A additional controls (see Appendix A for the control wordings)


Application

method

The environmental risk assessment indicates that restrictions on the application method of this

substance are necessary to mitigate the risk of death or adverse effects that it could present to

organisms in the environment. Accordingly, it is considered 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.

Restriction

on impurity

The active ingredient in Artist, flufenacet, is associated with the toxicologically significant impurity

toluene. When present in high enough concentrations, this impurity can cause adverse effects to

people. Imposing a restriction on the maximum amount of impurity in flufenacet will prevent it

from occurring in concentrations sufficient to cause adverse effects to people. Accordingly, it is

considered that the application of an additional control to address this concern will be more

effective than the prescribed controls with respect to its effect on the management, use and risks

of the substance.

Label The environmental risk assessment indicates that runoff is likely to occur and could lead to

adverse effects to organisms in the environment. Accordingly, it is considered that the addition of

a label statement describing situations where runoff is likely to occur will be more effective than

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the prescribed controls with respect to their effects on the management, application and risks of

this substance

Assessment of changes to controls

6.3. The changes to the prescribed controls in the above section under sections 77 and 77A of the Act fulfil

the legislative criteria.

6.4. These controls have been incorporated into the Appendix of this document.

6.5. The applicant was provided an opportunity to comment on the first version of proposed controls, in

particular the recommendation for a 30 m buffer zone to mitigate risks to the aquatic environment from

runoff. The applicant raised concerns in regard to the 30 m runoff buffer zone, which they consider to

needlessly impair farming operations. They supported their argument by proposing revised toxicity

endpoints for algae and aquatic plants for both active ingredients and a rationale for this endpoint

selection, as well as their own aquatic risk assessment.

6.6. The EPA staff assessed the additional information supplied by the applicant and agreed with using

their proposed toxicity endpoints for algae and aquatic plants to update the aquatic risk assessment.

6.7. The outcome of this updated risk assessment is presented in the science memorandum and this

decision and the proposed buffer zone is reduced to 15 m.

7. Summary

7.1. After taking into account the prescribed controls and any variations to these controls, it was concluded

that the residual level of risk of any potentially significant adverse effects, is negligible. Significant

benefits were identified and it is considered that they outweigh the negligible risks presented by Artist.

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8. Decision

8.1. 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. I have also

taken into account the considerations set out in Part 2 of the Act.

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

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

I consider that Artist is approved with controls 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: 23 May 2019

Chief Executive, EPA

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Appendix: Controls applying to Artist

EPA Controls

Control

code EPA Notice Control description

LAB EPA Labelling Notice 2017 Requirements for labelling of hazardous substances

PKG EPA Packaging Notice 2017 Requirements for packaging of hazardous substances

SDS EPA Safety Data Sheet Notice

2017 Requirements for safety data sheets for hazardous substances

DIS EPA Disposal Notice 2017 Requirements for disposal of hazardous substances

HPC-1 EPA Hazardous Property

Controls Notice 2017 Part 1 Hazardous Property Controls preliminary provisions


Controls Notice 2017 Part 3 Hazardous substances in a place other than a workplace

HPC-4A EPA Hazardous Property

Controls Notice 2017 Part 4A Site and storage controls for class 9 substances

HPC-4B EPA Hazardous Property

Controls Notice 2017 Part 4B Use of class 9 substances

HPC-4C EPA Hazardous Property

Controls Notice 2017 Part 4C Qualifications required for application of class 9 pesticides

HSNO Additional Controls and Modifications to Controls

Control

Code HSNO Act Control

Application

rate

Section 77 variation

to HPC Notice

clause 50

The maximum application rate for Artist is 0.6 kg of flufenacet/ha and

0.4375 kg of metribuzin/ha which equates to 2.5 kg of formulated

substance applied per hectare. The maximum number of application is one

per calendar year.

Buffer

zone


to HPC notice

clause 51

The person in charge of the application of this substance and any person

applying this substance must ensure that the substance is not applied

within 15 m of any waterbody.



within 5 m of downwind non-target plants.

Application

method Section 77A

This substance must only be applied using ground-based equipment with a

low boom (spray boom

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and Biological Engineers ASABE Standard (S572) or the British Crop

Production Council guideline.

The substance must not be applied when wind speeds are less than 3

km/hr or more than 20 km/hr as measured at the application site.

Label Section 77A

The label must include the following statement, or words to the same effect:

“To reduce runoff from treated areas into aquatic habitats, characteristics

and conditions of the site must be considered. Site characteristics and

conditions that may lead to runoff include, but are not limited to, heavy

rainfall, moderate to steep slope, bare soil, poorly draining soil (eg soils that

are compacted, fine textured or low in organic matter such as clay). Avoid

application of Artist when heavy rain is forecast.”

Maximum

impurity Section 77A

The following limit is proposed for toxicologically relevant impurity in the

technical grade active ingredient flufenacet:

• Toluene: maximum 1 g/kg

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HSW HS Requirements

Note: these requirements are not set for the substance under this approval but apply in their own right under

the HSW Act and HSW (HS) Regulations according to the classification of the substance. They are listed

here for information purposes only.

Code Regulation Description

HSW2-1 Reg 2.1 - 2.4 Workplace labelling of hazardous substance containers

HSW2-2 Reg 2.5 - 2.10 Signage

HSW2-3 Reg 2.11 Safety data sheets

HSW2-4 Reg 2.12 - 2.14 Packaging

HSW3-1 Reg 3.1 Inventory

HSW3-2 Reg 3.2 - 3.3 Managing risks associated with hazardous substances

HSW4-2 Reg 4.5 - 4.6 Information, instruction, training and supervision

HSW5-2 Reg 5.6 - 5.13 Emergency response plans

HSW13-2 Reg 13.7 Duty of PCBU who directs work using class 6, 8.1, 8.2, or 8.3 substances to

ensure equipment is appropriate

HSW13-3 Reg 13.8 Duty of PCBU who directs work using class 6 and 8 substances to ensure

personal protective equipment used

HSW13-7 Reg 13.14 - 13.16 Transportation of certain class 6 and 8 substances

HSW13-8 Reg 13.17 Prohibition on use of substance in excess of tolerable exposure limit

HSW13-9 Reg 13.18 Duty of PCBU to ensure prescribed exposure standards for class 6

substances not exceeded

HSW16-1 Part 16 Requirements for tank wagons and transportable containers

HSW17-1 Part 17 Requirements for stationary container systems

http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309727.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309731.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309739.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309741.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309745.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309746.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309755.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309766.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310266.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310266.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310267.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310267.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310275.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310280.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310281.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310281.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310672.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310760.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2

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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

Coarse spray Coarse spray, as classified by the American Society of Agricultural & Biological Engineers (ASABE)

the British Crop Production Council guideline droplet size classification scheme.

Ground-based

application

Ground-based methods of applying pesticides include, but are not limited to, application by ground

boom, airblast or knapsack, and do not include aerial application methods.

Likely Good chance that it may occur under normal operating conditions.

Medium spray Medium spray, as classified by the American Society of Agricultural & Biological Engineers (ASABE)


Waterbody

Includes all natural and modified/artificial water courses such as reservoirs, irrigation canals, water-

supply races, canals for the supply of water for electricity generation or farm drainage, ditches,

streams, rivers, ponds and lakes. For clarity, it excludes fully covered pipes, tanks or other enclosed

structures, puddles or groundwater.

DECISION

23 May 2019

Summary

Substance Artist

Application code APP203344

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 Bayer New Zealand Limited

Purpose of the application To import Artist, a pre-emergence selective herbicide containing 240

g/kg flufenacet and 175 g/kg metribuzin in the form of a water

dispersible granule for the control of annual weeds in potatoes

Date application formally received 18 December 2017

Consideration date 22 – 23 May 2019

Further information was requested from the applicant during the

evaluation and review of the application in accordance with section 52

of the Act and the consideration was 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 HSR101359

Hazard classifications 6.1D (oral), 6.1E (dermal), 6.1D (inhalation), 6.5B, 6.9B (oral and

inhalation), 9.1A, 9.2A, 9.3C

1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.

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1. Substance

1.1. Artist is a water dispersible granule herbicide containing 175 g/kg of metribuzin and 240 g/kg of

flufenacet as the active ingredients. It is intended to be imported and used by professional users to

control various weeds in potatoes. Artist is intended to be applied using ground-based boom

application methods.

1.2. Both active ingredients in Artist are approved for use in New Zealand but their combination is new and

the application rate of flufenacet is higher than in other substances, therefore human and ecological

quantitative risk assessments were conducted.

2. Process and consultation

Application receipt

2.1. The application was formally received on 18 December 2017 under section 28 of the Act.

Information available for consideration

2.2. The information available for the consideration comprised:

the application form

the confidential appendices to the application

the science memorandum.

2.3. Further information was requested from the applicant in accordance with section 52 of the Act.

2.4. With the further information received from the applicant, it is considered that there is sufficient

information to assess this application.

Public notification

2.5. 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

2.6. The following government departments were notified of the application on 19 December 2017: the

Ministry for Primary Industries (Agricultural Compounds and Veterinary Medicines Group) and the

Department of Conservation. No comments were received.

2.7. As the agency responsible for overseeing the Health and Safety at Work (HSW) Act and Regulations,

WorkSafe New Zealand (“WorkSafe”) has responsibility for assessing that the HSW requirements are

adequate to manage the risks from the substance. WorkSafe was notified of the application under

section 53(4) on 19 December 2017 and provided with the appropriate documents to allow them to

make this assessment. The comments from WorkSafe are summarised in Section 4 of this document.

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Legislative criteria for the application

2.8. The application was considered under section 29 of the Act, taking into account other relevant

sections of the Act, the EPA Notices, the HSW Act, the HSW (Hazardous Substances) Regulations

and the Hazardous Substances and New Organisms (Methodology) Order 1998.

3. Hazardous properties of Artist

3.1. The hazard classifications of Artist were determined based on the information provided by the

applicant (including toxicity and ecotoxicity studies), information on the individual components of Artist,

mixture rules and other available information (reports from overseas regulatory agencies).

3.2. The classifications that have been applied to Artist are different to those submitted by the applicant

(Table 1). The difference in classifications has arisen due to different interpretations of the study

submitted for the dermal toxicity classification and the misinterpretation of the mixture classification

rules by the applicant for toxicity via the inhalation route and ecotoxicity to soil organisms.

Table 1: Hazard classifications of Artist

Hazard Applicant classification EPA classification

Acute toxicity (oral) 6.1D 6.1D

Acute toxicity (dermal) No 6.1E

Acute toxicity (inhalation) ND* 6.1D

Contact sensitisation 6.5B 6.5B

Target organ or systemic toxicity (oral and

inhalation) 6.9B 6.9B

Aquatic ecotoxicity 9.1B 9.1A

Soil ecotoxicity No 9.2A

Terrestrial vertebrate ecotoxicity 9.3C 9.3C

* ND: Not Determined

4. Risk and benefit assessment

Risk assessment

4.1. The risk assessment has taken into account the hazardous properties of the substance, the

considerations in Part 2 of the Act, the prescribed controls under the Act and the requirements under

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

and Maritime Transport Act 1994.

4.2. The human health and 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, including import and

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

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4.3. The EPA staff determined that there is a potential for significant exposures to people and the

environment during the use phase of Artist.

4.4. Although the active ingredients in Artist are already approved individually in New Zealand via other

substances, a quantitative risk assessment was conducted because the combination of the two active

ingredients was new and the use pattern has a higher application rate than the already existing

formulations already on the market in New Zealand.

4.5. The risk and benefit assessment:

considered the risks posed by Artist,

determined whether the risks are outweighed by the benefits,

determined whether any variations, additions to or deletion of the prescribed controls are

required to manage the risks of the substance.

Assessment of risks to human health

4.6. Artist is intended to be supplied to the professional market. Users are expected to dilute the substance

in water and apply the substance using high volume broadcast/ground-based boom spraying

equipment. It is likely that users will be exposed to the substance during the mixing, loading and

application stages of the substance.

4.7. The potential risks posed by Artist to human health were assessed by estimating the exposure of

operators, re-entry workers and bystanders to the active ingredients, metribuzin and flufenacet. The

risks from exposure to metribuzin and flufenacet are considered as the main contributors to the hazard

properties of Artist.

4.8. To assess the risks posed by the substance to human health, the estimated exposure to each active

ingredient for the application on potatoes was compared to an Acceptable Operator Exposure Limit

(AOEL) value for each active ingredient and a risk quotient (RQ) is calculated. The AOEL used for

metribuzin is 0.02 mg/kg bw/day and an AOEL value of 0.017 mg/kg bw/day is used for flufenacet.

4.9. RQ values greater than one (RQ>1) indicate that exposure to the substance could result in significant

adverse effects, and that risk mitigating controls should be considered. RQ values less than one

(RQ

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4.11. No exposure from re-entry activity is expected because Artist is used as a pre-emergence herbicide,

therefore contact with foliar residues is very unlikely. Therefore, no restricted entry interval is

necessary.

4.12. The estimated risks to bystanders are also below the level of concern and no buffer zones are

proposed to mitigate risks to human health.

4.13. Artist is also a contact sensitizer (6.5B), any long term effects would require multiple exposures to this

substance over a time period which is unlikely. It is considered that the likelihood of significant

exposure would be reduced by the prescribed requirements under the HSW (HS) Regulations to use

PPE to minimise risks to the health and safety of workers, and by the prescribed controls under the

Act to provide information on the label and safety data sheet for Artist. As such, the risk from the

contact sensitisation hazard is assessed as being negligible.

4.14. With these controls and requirements in place, the overall level of risk to human health during the use

phase of Artist is considered negligible.

Assessment of risks to human health from workplace activities

4.15. WorkSafe was notified of the application and has provided the following comment on whether the

HSW requirements manage the risk to people from workplace activities.

4.16. WorkSafe has assessed the available information of APP203344 and considers that compliance with

the HSW and General Risk and Workplace Management Regulations will be adequate to reduce the

risks associated with the use of this substance in the workplace. While the regulations cover standard

risk mitigation measures, occupational exposure in the workplace needs to be assessed at each site

and appropriate controls put in place to mitigate the identified risks.

4.17. WorkSafe notes that a number of the new herbicide products approved in New Zealand in the last 5

years do not have human health hazards. Under Sections 39 - 42 of the HSW Act 2015,

manufacturers/importers/suppliers have a duty to ensure substances manufactured, imported or

supplied are without risk so far as is reasonably practicable. Applicants should be mindful of their

duties under the Health and Safety at Work Act 2015 when they apply for approval of new substances.

4.18. When using substances that have human health risks the PCBU must minimise the risks so far as

reasonably practicable by applying the hierarchy of controls set out in regulation 6 of the General Risk

and Workplace Management Regulations 2016. Personal protective equipment (PPE) may need to be

used or worn to minimise health risks, but should only be used as a control measure to eliminate risk

when other control measures alone cannot adequately do so. PPE should not be the first or only

control considered and WorkSafe expects PCBUs to give preference to other controls that protect

multiple at-risk workers at once.

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Assessment of risks to the environment

4.19. The potential risks posed by Artist to aquatic and terrestrial environments were assessed for the use

pattern proposed by the applicant. The EPA evaluated this use pattern and performed quantitative

modelling to determine the predicted environmental exposures.

Aquatic ecotoxicity (9.1A)

4.20. It was determined that the risks from the formulation with the two active ingredients could be estimated

from the results obtained in tests with “pure” active ingredients because there is no evidence that

flufenacet and metribuzin interact with each other or that their combination increases the toxicity

compared to the effects expected with each individual active ingredient.

4.21. Metribuzin and flufenacet are not rapidly degradable in the aquatic environment and are considered

persistent in aquatic environment (DT50 > 16 days) but are not bioaccumulative.

4.22. The metabolites of both active ingredients were less toxic than the parents for the endpoints used in

the risk assessment, therefore the metabolites were not included in the risk assessment.

4.23. The main potential source for aquatic organisms to be exposed to Artist is by spray drift during

application and surface water runoff after the substance is applied.

4.24. The predicted acute exposures to flufenacet and to metribuzin from spray drift and runoff were above

the level of concern for algae and aquatic plants. Therefore, further modelling was performed to

determine the buffer zones necessary to mitigate the risks to algae and aquatic plants from spray drift

and runoff.

4.25. The modelling, which took into account the intended method of application, determined that the risks

to aquatic plants from runoff could be managed by buffer zones. The buffer zone to protect water

bodies from runoff is 15 metres. The buffer zone to protect waterbodies from spray drift is 5 metres,

therefore the buffer zones to mitigate risks from runoff will also mitigate risks from spray drift.

4.26. An additional label control is also proposed to alert the users of situations where runoff is likely.

4.27. As the size of the buffer zone was calculated based on the specific application scenario requested by

the applicant, restrictions on application methods as well as a maximum application rate and

application frequency have also been set as controls when using this substance. In particular, the

application method is restricted to low boom, the minimum droplet size is restricted from medium to

coarse and the maximum application rate to 2.5 kg of Artist per hectare (equivalent to 600 g/ha of

flufenacet and 437.5 g/ha of metribuzin), with a maximum of one application per calendar year.

4.28. A risk of potential groundwater contamination by flufenacet that could affect groundwater community

was identified by the model. This risk could not be mitigated, but its effects are expected to be low.

4.29. No risk assessment could be performed for sediment-dwelling organisms due to a lack of data.

Therefore, the precautionary approach would consider that there is a potential low risk to sediment-

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dwelling organisms. However, with the application restrictions and buffer zones in place, this risk is

considered to be negligible.

4.30. With the buffer zones, application restrictions and other prescribed controls, the residual risks to the

aquatic environment are assessed as being negligible.

Toxicity to soil environment (9.2A)

4.31. Metribuzin is rapidly degradable in the soil environment but flufenacet is not and is therefore

considered persistent (DT50 > 28 days).

4.32. No acute risks were identified for earthworms, but no data were available to assess chronic risks; this

is a significant data gap because flufenacet is considered persistent in soil.

4.33. Risks to non-threatened and threatened non-target plants were identified, but could be mitigated with

downwind 5 metre buffer zones. Therefore, with controls in place, risks to non-target plants are

negligible.

Toxicity to terrestrial vertebrates (9.3C)

4.34. Risks above the level of concern were identified at the screening and first tier assessments for birds.

After further refinement, acute and chronic risks were estimated to be below the level of concern for

non-threatened species, and exposure was considered unlikely for threatened species. Therefore the

risks to birds are considered negligible.

Cultural Assessment

4.35. Kaupapa Kura Taiao (The EPA’s Māori Policy and Operations team) has undertaken a cultural

assessment to consider potential impacts of the application on the economic, social, and cultural well-

being of Māori, and the relationship of Māori with the environment, pursuant to sections 5(b), 6(d) and

8 of the HSNO Act. The cultural assessment includes tangible and intangible taonga, such as

culturally significant species, resources, and places, and the customary values, practices and uses

associated with these taonga. Key findings of the assessment are outlined below.

Impact on the relationship of Māori and their culture and traditions with their environment and

taonga




Impact on the maintenance and enhancement of the capacity of people and communities to

provide for their own economic, social and cultural well-being




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Treaty of Waitangi principles

4.38. The Principles of the Treaty of Waitangi have been considered in relation to this application, as

summarised below.

4.39. The active protection principle: the Crown has a duty to actively protect Māori interests. No issues

arise.

4.40. The informed decision making principle: the Crown has a duty to make informed decisions. No issues

arise.

4.41. The partnership principle: to act fairly, reasonably, and in good faith. No issues arise..

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

4.42. No risks to society, communities or the market economy from the approval of Artist have been

identified.

New Zealand’s international obligations

4.43. No international obligations that may be impacted by the approval of Artist have been identified.

The effects of the substance being unavailable

4.44. The likely effects of Artist being unavailable in accordance with section 29(1) of the Act have been

considered. Should Artist not be available, it could lead to less consumer choice.

Assessment of benefits

4.45. The applicant considers that the approval of Artist will provide the following benefits:

Increased choice for farmers

Broader range of weeds controlled

Less resistance because of the combination of two active ingredients

4.46. There are currently 12 active ingredients registered for use as herbicides on potatoes (bentazone,

clomazone, cyanazine, fluazifop-P-butyl, linuron, methabenzthiazuron, metribuzin, prometryn,

quizalofop-P-ethyl, sulfentrazone, terbuthylazine, terbutryn), used in 38 formulated products.

4.47. There are currently ten registered products with metribuzin and two with flufenacet as the active

ingredients on ACVM. None of the registered products combine the two active ingredients and none of

the two products with flufenacet are used on potatoes.

4.48. The products containing metribuzin claim to control the following weeds: amaranthus, barnyard grass,

charlock, chickweed, fat hen, field speedwell, fumitory, galinsoga, groundsel, henbit, nettle, plantain,

redroot, scentless chamomile, shepherds purse, spurrey, small-flowered buttercups, stinking

mayweed, storks bill, twin cress, white campion, wild radish, wild turnip, willow weed, wireweed. They

also control these moderately susceptible weeds: cornbind, sow thistle, seedling docks, seedling

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Californian thistle, summer grasses. These products do not control: black nightshade, cleaver, dock,

giant buttercup, most deep-rooting weeds and most weeds over 4 leaf stage.

4.49. The products containing flufenacet claim to control the following weeds: brassicas, chickweed,

cleaver, field pansy, field madder, hedge mustard, mouse-ear chickweed, rayless chamomile,

scentless chamomile, seedling dock, shepherd's purse, sow thistle, speedwell, spurrey, storks bill,

vetch, annual poa and vulpia hair grass.

4.50. Artist is proposed to control the following weeds: yarrow, fat hen, fumitory, cleaver, narrow leaf

plantain, clover, field pansy, perennial ryegrass and black nightshade (moderately susceptible).

Therefore, Artist is claimed to control six weeds not controlled by currently approved products

containing only one of the two active ingredients in Artist (yarrow, cleaver, clover, field pansy,

perennial ryegrass and black nightshade). This is considered a significant benefit.

4.51. Although the benefits identified above were not verified by the EPA, it is considered that the availability

of Artist will provide beneficial economic effects for some businesses with the potential for flow-on

effects to local communities and the New Zealand economy, including improved consumer choice and

greater market competition.

5. Prescribed controls

5.1. The hazard classifications of Artist determine a set of prescribed controls, specified by the EPA

Notices2 under section 77 of the Act. There are also requirements in the HSW (HS) Regulations. Note:

the HSW (HS) requirements are not set for the substance under this approval but apply in their own

right.

5.2. The prescribed controls set the baseline for how the substance must be managed and include

specifications on how the substance is to be packaged, labelled, stored, disposed, transported,

handled and used. The prescribed controls also set information requirements (eg Safety Data Sheets),

signage and emergency management. These controls form the basis of the controls specified in

Appendix A.

Exposure limits

5.3. Under s77B of the Act, the EPA may set a Tolerable Exposure Limit (TEL) and/or an Environmental

Exposure Limit (EEL) for a substance with toxic or ecotoxic properties.

Regulation 13.17 of the HSW (HS) Regulations prohibits the use of a class 6 substance in

excess of a TEL.

Clause 49 of the Hazardous Property Controls Notice prohibits use of a class 9 substance in

excess of an EEL.

2 There may also be default controls in regulations made under the Act for certain hazardous substances such as fireworks.

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5.4. The EPA had provided ADE (Acceptable Daily Exposure) and PDE (Potential Daily Exposure) values

for flufenacet but not for metribuzin. These values have been updated for flufenacet and provided for

metribuzin.

5.5. It is considered that the following values are suitable for flufenacet:




PDE(other) = 0.0005

5.6. It is considered that the following values are suitable for metribuzin:




PDE(other) = 0.0015

Acute reference dose (ARfD) = 0.02 mg/kg bw/day

5.7. The ADE and PDE shown above are proposed by the EPA as health-based exposure guidance values

that can be used to inform risk assessments as well as the setting of controls, such as Maximum

Residue Levels under the Agricultural Compounds and Veterinary Medicines Act 1997.

5.8. However, the EPA has not set a TEL for Artist, or any element or compound in the substance, as

exposure to this substance is not likely to result in an appreciable toxic effect to people, provided

controls on use are followed.

5.9. EEL values for water and soil have been set previously for metribuzin but not for flufenacet. However,

EELs are not applicable to Artist because the level of risk of adverse effects to the environment has

been qualitatively assessed as being negligible, with controls in place.

5.10. There are Workplace Exposure Standard (WES) values currently set for components of Artist but, as

they are not Prescribed Exposure Standard (PES) values, they are guidance values used for the

management of health risk. No PES has been set for any component of Artist.

5.11. Clause 17 of the Labelling Notice requires that certain toxic or corrosive components are identified on

the product label. Section 3 of Schedule 1 of the Safety Data Sheet (SDS) Notice requires certain toxic

or corrosive components are identified on the SDS. Section 8 of Schedule 1 of the SDS Notice

requires occupational exposure limits to be identified on the SDS, and Section 15 requires TEL and

EEL to be identified on the SDS. One component of Artist has a Workplace Exposure Value (WES).

5.12. The name and concentration of the following components need to be specified on the label and SDS

(Table 2):

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Table 2 List of components requiring identification

Label SDS

Metribuzin (6.1D, 6.9B) Metribuzin (6.1D, 6.9B, 9.1A)

Flufenacet (6.5B, 6.9B) Flufenacet (6.5B, 6.9B, 9.1A)

Kaolin (WES)

6. Changes to prescribed controls

6.1. The following modifications to the EPA Notice controls apply to Artist, as set out in Table 2:

Table 2: Justification for section 77 changes to the prescribed controls (see Appendix A for control

wordings)


Buffer zone

HPC Notice

Clause 51

HPC Clause 51 allows the EPA to set buffer zone distances as an additional control for a class 9

substance. Buffer zone distances are necessary to mitigate the risks to waterbodies from runoff

and spray drift. Clause 25 of the Labelling Notice requires buffer zones and associated relevant

application methods to be stated on the label.

Application

restrictions

HPC Notice

Clause 50

Significant environmental risks may occur from the use of this substance, due to the hazards

posed by flufenacet and metribuzin, the active ingredients in Artist. Therefore, it is considered

necessary to set a maximum application rate, number of applications and frequency under

clause 50 of the HPC Notice.

6.2. The following additional HSNO controls apply to Artist under section 77A of the Act, as set out in Table

3:

Table 3: Justification for the section 77A additional controls (see Appendix A for the control wordings)


Application

method

The environmental risk assessment indicates that restrictions on the application method of this

substance are necessary to mitigate the risk of death or adverse effects that it could present to

organisms in the environment. Accordingly, it is considered 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.

Restriction

on impurity

The active ingredient in Artist, flufenacet, is associated with the toxicologically significant impurity

toluene. When present in high enough concentrations, this impurity can cause adverse effects to

people. Imposing a restriction on the maximum amount of impurity in flufenacet will prevent it

from occurring in concentrations sufficient to cause adverse effects to people. Accordingly, it is

considered that the application of an additional control to address this concern will be more

effective than the prescribed controls with respect to its effect on the management, use and risks

of the substance.

Label The environmental risk assessment indicates that runoff is likely to occur and could lead to

adverse effects to organisms in the environment. Accordingly, it is considered that the addition of

a label statement describing situations where runoff is likely to occur will be more effective than

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the prescribed controls with respect to their effects on the management, application and risks of

this substance

Assessment of changes to controls

6.3. The changes to the prescribed controls in the above section under sections 77 and 77A of the Act fulfil

the legislative criteria.

6.4. These controls have been incorporated into the Appendix of this document.

6.5. The applicant was provided an opportunity to comment on the first version of proposed controls, in

particular the recommendation for a 30 m buffer zone to mitigate risks to the aquatic environment from

runoff. The applicant raised concerns in regard to the 30 m runoff buffer zone, which they consider to

needlessly impair farming operations. They supported their argument by proposing revised toxicity

endpoints for algae and aquatic plants for both active ingredients and a rationale for this endpoint

selection, as well as their own aquatic risk assessment.

6.6. The EPA staff assessed the additional information supplied by the applicant and agreed with using

their proposed toxicity endpoints for algae and aquatic plants to update the aquatic risk assessment.

6.7. The outcome of this updated risk assessment is presented in the science memorandum and this

decision and the proposed buffer zone is reduced to 15 m.

7. Summary

7.1. After taking into account the prescribed controls and any variations to these controls, it was concluded

that the residual level of risk of any potentially significant adverse effects, is negligible. Significant

benefits were identified and it is considered that they outweigh the negligible risks presented by Artist.

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8. Decision

8.1. 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. I have also

taken into account the considerations set out in Part 2 of the Act.

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

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

I consider that Artist is approved with controls 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: 23 May 2019

Chief Executive, EPA

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Appendix: Controls applying to Artist

EPA Controls

Control

code EPA Notice Control description

LAB EPA Labelling Notice 2017 Requirements for labelling of hazardous substances

PKG EPA Packaging Notice 2017 Requirements for packaging of hazardous substances

SDS EPA Safety Data Sheet Notice

2017 Requirements for safety data sheets for hazardous substances

DIS EPA Disposal Notice 2017 Requirements for disposal of hazardous substances


Controls Notice 2017 Part 1 Hazardous Property Controls preliminary provisions


Controls Notice 2017 Part 3 Hazardous substances in a place other than a workplace

HPC-4A EPA Hazardous Property

Controls Notice 2017 Part 4A Site and storage controls for class 9 substances

HPC-4B EPA Hazardous Property

Controls Notice 2017 Part 4B Use of class 9 substances

HPC-4C EPA Hazardous Property

Controls Notice 2017 Part 4C Qualifications required for application of class 9 pesticides

HSNO Additional Controls and Modifications to Controls

Control

Code HSNO Act Control

Application

rate


to HPC Notice

clause 50

The maximum application rate for Artist is 0.6 kg of flufenacet/ha and

0.4375 kg of metribuzin/ha which equates to 2.5 kg of formulated

substance applied per hectare. The maximum number of application is one

per calendar year.

Buffer

zone


to HPC notice

clause 51



within 15 m of any waterbody.



within 5 m of downwind non-target plants.

Application

method Section 77A

This substance must only be applied using ground-based equipment with a

low boom (spray boom

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and Biological Engineers ASABE Standard (S572) or the British Crop

Production Council guideline.

The substance must not be applied when wind speeds are less than 3

km/hr or more than 20 km/hr as measured at the application site.

Label Section 77A

The label must include the following statement, or words to the same effect:

“To reduce runoff from treated areas into aquatic habitats, characteristics

and conditions of the site must be considered. Site characteristics and

conditions that may lead to runoff include, but are not limited to, heavy

rainfall, moderate to steep slope, bare soil, poorly draining soil (eg soils that

are compacted, fine textured or low in organic matter such as clay). Avoid

application of Artist when heavy rain is forecast.”

Maximum

impurity Section 77A

The following limit is proposed for toxicologically relevant impurity in the

technical grade active ingredient flufenacet:

• Toluene: maximum 1 ppm

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HSW HS Requirements

Note: these requirements are not set for the substance under this approval but apply in their own right under

the HSW Act and HSW (HS) Regulations according to the classification of the substance. They are listed

here for information purposes only.

Code Regulation Description

HSW2-1 Reg 2.1 - 2.4 Workplace labelling of hazardous substance containers

HSW2-2 Reg 2.5 - 2.10 Signage

HSW2-3 Reg 2.11 Safety data sheets

HSW2-4 Reg 2.12 - 2.14 Packaging

HSW3-1 Reg 3.1 Inventory

HSW3-2 Reg 3.2 - 3.3 Managing risks associated with hazardous substances

HSW4-2 Reg 4.5 - 4.6 Information, instruction, training and supervision

HSW5-2 Reg 5.6 - 5.13 Emergency response plans

HSW13-2 Reg 13.7 Duty of PCBU who directs work using class 6, 8.1, 8.2, or 8.3 substances to

ensure equipment is appropriate

HSW13-3 Reg 13.8 Duty of PCBU who directs work using class 6 and 8 substances to ensure

personal protective equipment used

HSW13-7 Reg 13.14 - 13.16 Transportation of certain class 6 and 8 substances

HSW13-8 Reg 13.17 Prohibition on use of substance in excess of tolerable exposure limit

HSW13-9 Reg 13.18 Duty of PCBU to ensure prescribed exposure standards for class 6

substances not exceeded

HSW16-1 Part 16 Requirements for tank wagons and transportable containers

HSW17-1 Part 17 Requirements for stationary container systems

http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309727.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309731.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309739.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309741.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309745.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309746.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309755.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309766.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310266.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310266.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310267.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310267.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310275.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310280.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310281.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310281.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310672.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7310760.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2

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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

Coarse spray Coarse spray, as classified by the American Society of Agricultural & Biological Engineers (ASABE)


Ground-based

application

Ground-based methods of applying pesticides include, but are not limited to, application by ground

boom, airblast or knapsack, and do not include aerial application methods.

Likely Good chance that it may occur under normal operating conditions.

Medium spray Medium spray, as classified by the American Society of Agricultural & Biological Engineers (ASABE)


Waterbody

Includes all natural and modified/artificial water courses such as reservoirs, irrigation canals, water-

supply races, canals for the supply of water for electricity generation or farm drainage, ditches,

streams, rivers, ponds and lakes. For clarity, it excludes fully covered pipes, tanks or other enclosed

structures, puddles or groundwater.

decision - epa...flufenacet and metribuzin interact with each other or that their combination...

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