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DECISION

www.epa.govt.nz

11 December 2019

Overview

Substances Paraquat and paraquat-containing substances

Application code APP203301

Application type To reassess any hazardous substance under section 63 of the Hazardous

Substances and New Organisms Act (“the Act”)

Applicant The Chief Executive (“CE”) of the Environmental Protection Authority (“the

EPA”)

Purpose of the application The EPA has applied for the reassessment of paraquat and paraquat-containing

substances

Submissions received Adama New Zealand Limited

Agpro NZ Limited

Dairy NZ

Department of Conservation – Auckland Conservancy

Farmlands Co-operative

Farmlands Grain & Seed

Federated Farmers of New Zealand

Horticulture New Zealand

Market Access Solutionz Limited

New Zealand Beekeeping Incorporated

Pearler Bay Farm

Potatoes New Zealand

Syngenta Crop Protection Limited

Te Wahapu o Hokianga Nui a Kupe

P Foster

A Talbot

D Morton

L Clapham

Considered by A Decision-Making Committee of the Environmental Protection Authority

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Decision on the reassessment of paraquat and paraquat-containing substances (APP203301)

December 2019

Decision Paraquat (HSR003041), Soluble concentrate containing 115 g/litre diquat as the

dibromide salt and 135 g/litre paraquat as the dichloride salt (HSR000447) and

Soluble concentrate containing 200 - 250 g/litre paraquat as the dichloride salt

(HSR000828) are approved with additional controls.

Gramoxone Inteon (HSR007847), Preeglone Inteon (HSR007854), Uniquat 250

(HSR100443) and Parable 250 (HSR100572) are declined. The decision to

decline the approvals comes into effect 12 months after the date of this decision

Approval codes HSR003041, HSR000447 and HSR000828

Hazard classifications See Tables 1, 2 and 3

Application dates

Date application received 25 February 2019

Submission period 28 February 2019 -11 April 2019, extended to 30 April 2019.

Hearing date 11 and 12 September 2019, closed 14 October 2019

Consideration date 14 October 2019

Date decision signed 11 December 2019

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Executive summary

Paraquat is a broad spectrum, non-systemic pesticide which is currently used as a herbicide to control

a large variety of broadleaf weeds, and annual and perennial grasses, in a variety of crops. It is

currently used in commercial agriculture, forestry, and has reported use in urban weed control.

Paraquat is also used as a pre-harvest desiccant.

In 2016 the EPA received an application for a herbicide containing paraquat (APP202697). The

assessment of this application identified that there were likely to be unacceptable risks to both human

health and the environment from the use of this substance, and that these risks could not be mitigated

through the application of controls. This application was therefore declined by the CE of the EPA.

Based on this decision, grounds to reassess the six existing approvals for paraquat-containing

substances, and the approval for paraquat itself, were granted by a decision-making committee on 3

July 2017. The grounds were established based on new information relating to the risks to human

health and the environment from the use of paraquat-containing substances, and this is the focus of

this reassessment.

On 25 February 2019 the EPA formally received an application for the reassessment of paraquat and

paraquat-containing substances. The application was publicly notified in accordance with section 53

of the Act.

During the submission period, 18 submissions were received on the application. The submissions

were split between different viewpoints. Some submitters opposed the continued approval of any

paraquat-containing substances, or ultimately held this position but were in support of the proposed

additional control implementation and revocation of some approvals. Other submitters were in favour

of re-approval and in support of controls mostly in line with those proposed by the EPA, while some

submitters were in support of re-approval of all approvals with no change in controls.

Seven of the submitters requested to speak at the hearing. On 11 and 12 September 2019, a hearing

was held in Wellington. The EPA presented at the hearing in support of the proposed changes to the

approvals for substances containing paraquat. Verbal submissions were heard from Market Access

Solutionz Limited, Potatoes New Zealand, Syngenta Crop Protection Limited (“Syngenta”),

Horticulture New Zealand, and Federated Farmers New Zealand. The hearing was adjourned, before

being closed on 14 October 2019.

After considering all relevant information available, the Decision-Making Committee (‘the Committee’)

decided that it had sufficient information for making a decision.

The Committee assessed the risks posed by paraquat and paraquat containing substances. The

Committee considered that there would be non-negligible risks to birds for all substances containing

paraquat with controls applied. The Committee assessed the benefits associated with the use of the

substances containing paraquat which were currently in use (those that had registered products under

the Agricultural Chemicals and Veterinary Medicines Act (ACVM Act)) and determined that those

benefits would be non-negligible. In accordance with section 29(1)(a) of the Act, the Committee

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December 2019

considered the positive effects of the substances Paraquat (HSR003041), Soluble concentrate

containing 115 g/litre diquat as the dibromide salt and 135 g/litre paraquat as the dichloride salt

(HSR000447) and Soluble concentrate containing 200 - 250 g/litre paraquat as the dichloride salt

(HSR000828) to outweigh the adverse effects and decided to approve them with controls. The

Committee considered that the substances HSR100443 and HSR100572 which had additional

carcinogenicity, mutagenicity or reproductive hazard classifications triggered by components other

than paraquat presented additional non negligible risks and that there was no evidence to suggest

that these additional components presented additional benefits. The committee therefore considered

in accordance with section 29(1)(a) of the Act, that the risks associated with the substances Uniquat

250 (HSR100443) and Parable 250 (HSR100572) outweighed the benefits and that their approvals

should be declined. The Committee assessed the benefits associated with the substances which were

not in use and/or those that did not have registered products under the Agricultural Chemicals and

Veterinary Medicines Act (ACVM Act)) (Gramoxone Inteon (HSR007847) and Preeglone Inteon

(HSR007854)). The committee considered that as these substances were not in use they did not

present any benefit. Therefore, in accordance with section 29(1)(a) of the Act, the Committee

considered there were no positive effects of the substances HSR007847 and HSR007854 to outweigh

the adverse effects and decided to decline their approvals.

Consequently, the Committee determined that the approvals HSR003041, HSR000447 and

HSR000828 are re-approved with additional controls and that the approvals HSR007847,

HSR007854, HSR100443 and HSR100572 are declined. The effect of the decision to decline the

approvals HSR007847, HSR007854, HSR100443 and HSR100572 comes into effect 12 months after

the date of this decision.

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December 2019

Table of Contents

Overview .................................................................................................................................................. i

Executive summary ................................................................................................................................ iii

1 Background ..................................................................................................................................... 1

2 Process, consultation and notification ............................................................................................ 1

Lodgement and formal receipt ........................................................................................................... 1

Scope of application ............................................................................................................................ 2

Notification of application .................................................................................................................. 2

Submissions received .......................................................................................................................... 2

3 The EPA update report .................................................................................................................... 3

4 Hearing ............................................................................................................................................ 4

EPA presentation ................................................................................................................................ 4

Committee questions ...................................................................................................................... 6

Submitter questions ........................................................................................................................ 7

Sapere presentation ............................................................................................................................ 8

Committee questions ...................................................................................................................... 9

Submitter questions ........................................................................................................................ 9

WorkSafe presentation ..................................................................................................................... 10

Committee questions .................................................................................................................... 10

Submitter questions ...................................................................................................................... 10

Presentations by submitters ............................................................................................................. 10

Federated Farmers (Ms Williams, and Mr Parker (Also spoke on behalf of Market Access

Solutionz Limited)) ........................................................................................................................ 10


EPA questions................................................................................................................................ 12

Grower organisation presentations on behalf of Market Access Solutionz Limited's submission

(Mr Salter (also spoke on behalf of Potatoes New Zealand), Mr De Bruin, and Mr Parker (also

spoke on behalf of Federated Farmers) ........................................................................................ 12


EPA questions................................................................................................................................ 15

Potatoes New Zealand presentation (Mr Salter (also spoke on behalf of Market Access Solutionz

Limited’s submission)) .................................................................................................................. 15


Horticulture New Zealand Presentation (Mr Heywood) ............................................................... 16


Syngenta presentation .................................................................................................................. 17

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EPA and WorkSafe questions ........................................................................................................ 19

Applicant/EPA right of reply ............................................................................................................. 20


Post hearing considerations .......................................................................................................... 21

5 Consideration ................................................................................................................................ 22

Information available for consideration ........................................................................................... 22

Hazardous properties ........................................................................................................................ 22

Proposed modification of controls ................................................................................................... 24

Assessment of risks ........................................................................................................................... 24

Risks during manufacture, packaging, importation, transportation, storage and disposal ......... 24

Risks during use ............................................................................................................................. 24

Human health effects .................................................................................................................... 25

Responsible handler provisions ............................................................................................................ 25

Environmental effects ................................................................................................................... 25

Risks to the aquatic environment ......................................................................................................... 25

Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators ......... 25

Risks to non-target plants ..................................................................................................................... 26

Risks to pollinators ................................................................................................................................ 26

Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators ......... 26

Risks to birds ......................................................................................................................................... 26

Assessment of risks to society, the community, and the market economy ................................. 27

Assessment of benefits ..................................................................................................................... 27

Cultural assessment .......................................................................................................................... 28

New Zealand’s international obligations .......................................................................................... 28

Amendments to proposed controls by the Committee .................................................................... 28

Direction to dispose of substances with declined approvals ............................................................ 28

Guidance on packaging requirements .............................................................................................. 29

6 Conclusion and decision ................................................................................................................ 29

Appendix A: Controls applying to retained approvals .......................................................................... 31

Appendix B: Decision path .................................................................................................................... 44

Decision path for applications to import or manufacture a hazardous substance, application made

under section 63 of the Act and determined under section 29. ........................................................ 45

Explanatory Notes ............................................................................................................................. 46


December 2019

1 Background

1.1 Paraquat is a broad spectrum, non-systemic pesticide commonly used as a herbicide to control

a large variety of broadleaf weeds, and annual and perennial grasses, in a variety of crops. It is

used in commercial agriculture, forestry, and has reported use in urban weed control. Paraquat

is also used as a pre-harvest desiccant.

1.2 In 2016 the EPA received an application for a new herbicide containing paraquat,

Para-Ken 250 (application APP202697). The assessment of this application identified that there

were likely to be unacceptable risks to both human health and the environment from the use of

this substance, and that these risks could not be mitigated through the application of controls.

This application was therefore declined by the CE of the EPA under delegated authority.

1.3 Based on this decision, grounds to reassess the six existing approvals for paraquat-containing

substances, as well as the approval for paraquat itself, were granted by a decision-making

committee. The grounds were established on the basis of new information relating to the risks

to human health and the environment from the use of paraquat-containing substances, and this

is the focus of this reassessment.

1.4 Paraquat and paraquat-containing substances have been reviewed by regulators in a number

of jurisdictions in recent years. These reviews have resulted in the use of paraquat being

further restricted with stringent risk mitigation measures put in place (United States of America,

Canada), or banned (European Union, Republic of Korea, Brazil).

1.5 The EPA applied for grounds to reassess paraquat and paraquat-containing substances in

June 2017. Grounds were granted for this reassessment on 3 July 2017 based on the new

information received in the Para-Ken 250 assessment (APP202697).

1.6 A call for information was undertaken between July and September 2017, in which the EPA

consulted with and requested information from representatives from industry, manufacturers,

suppliers and users of paraquat formulations, as well as local and central government. The

EPA received information from a number of sources including key grower industries which use

paraquat and Syngenta Crop Protection Limited, the intellectual property holder for paraquat.

1.7 On 25 February 2019 the EPA formally received an application for the reassessment of

paraquat and paraquat-containing substances. The submission period began on 28 February

2019 and closed on 30 April 2019. A hearing was held on 11 and 12 September 2019.

2 Process, consultation and notification

Lodgement and formal receipt

2.1 The EPA reassessment application was formally received on 25 February 2019. In their

application to reassess paraquat herbicides, the EPA proposed the following

Decline four approvals (HSR007847, HSR007854, HSR100443 and HSR100572)

Approval of paraquat with additional controls

Approval of two paraquat herbicides (HSR000447 and HSR000828) with the following

additional controls:

Maximum application rates

Permissions

Use restrictions


December 2019

Responsible handling provisions

Scope of application

2.2 The EPA’s Chief Executive considered the content of the application and decided not to use the

EPA’s discretionary power in section 63A of the Act to undertake a modified reassessment but

instead to proceed with the application as a full reassessment under section 63 of the Act.

Notification of application

2.3 The Ministry for the Environment, the Ministry of Health, the Agricultural Compounds and

Veterinary Medicines (ACVM) group of the Ministry for Primary Industries, the Department of

Conservation (DoC), and Fire and Emergency New Zealand (FENZ) were advised of the

application and notified of the submission period. FENZ was the only agency to respond: “we

have no issue with this type of change so will not make a submission in this case.”

2.4 WorkSafe New Zealand (“WorkSafe”) were also contacted to provide comment and input on

this application. WorkSafe provided input as a member of the project team for this application

and through the provision of a report relating to the work place health and safety aspects of the

paraquat reassessment, which was presented in Appendix G of the application form1.

2.5 The application was opened for submissions from 28 February 2019 and the submission period

was due to close on 11 April 2019, however at the request of three submitters the submission

period was extended to 30 April 2019.

Submissions received

2.6 Submitter support for and opposition to the initial proposals relating to the approvals can be

summarised as:

opposed to any re-approval of paraquat-containing substances (2);

in support of revocation of some paraquat approvals and implementation of additional risk

mitigation measures proposed for any substances to be re-approved, but ultimately with a

view that the approvals for all paraquat-containing substances should be revoked (3);

no indication of position in regard to proposals (1);

general support for re-approving paraquat-containing substances with no indication of

position in regard to proposed controls, (3);

in support of re-approving paraquat-containing substances and additional controls mostly

aligned with those proposed in the application form (3);

in support of re-approving paraquat-containing substances, but opposed to the additional

controls proposed in the application form (6).

2.7 The main proposed controls this group of submitters were generally opposed to include:

maximum application rate and frequency;

additional record-keeping requirement;

controls WorkSafe were considering to implement, including: health monitoring

requirements, additional licensing requirements, closed mixing/loading requirements,

1 https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/7baf298079/APP203301-Appendix-G-WorkSafe-

report.pdf

https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/7baf298079/APP203301-Appendix-G-WorkSafe-report.pdf

https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/7baf298079/APP203301-Appendix-G-WorkSafe-report.pdf


December 2019

prohibition of hand-held use, requirements to use closed cab application methods, and

additional record-keeping requirements.

2.8 Some submitters also indicated a number of issues with the methodology used by the EPA to

refine the risk assessment to produce the updated risk assessment provided with the EPA

update report.

2.9 The Committee took account of these submissions in making its decision and noted that the

EPA update report responded to these issues.

3 The EPA update report

3.1 The EPA update report provided responses to issues raised in submissions and contained an

update on the proposals detailed in the reassessment application document. It provided

information to assist the Committee to make its decision.

3.2 The EPA update report included the initial risk assessment as set out in the application form,

together with an updated risk assessment for paraquat, based on information provided by

submitters.

3.3 Confidential information was provided by multiple submitters, including Syngenta Crop

Protection Limited – the intellectual property owners for paraquat, which was taken into account

during the assessment of paraquat-containing substances. The confidential information

included study information on the human health and environmental adverse effects associated

with paraquat as well as economic information pertinent to the economic impact of paraquat.

3.4 The previous risk assessment2 on the use of a paraquat-containing substance found that the

risks to operators, re-entry workers, and bystanders were all non-negligible; and WorkSafe

agreed. The previous risk assessment on the aerial use of paraquat-containing substances also

found that the risks to soil organisms, non-target plants, sediment-dwelling organisms, and

birds were non-negligible. There were mixed impacts on beneficial arthropods.

3.5 The EPA proposed a suite of prescribed controls based on the hazard classifications of

paraquat and the paraquat containing substances which the EPA proposed for re-approval. The

EPA also considered variations to these controls, and the addition of extra controls, in

accordance with section 77 and section 77A of the Act.

3.6 The EPA update report concluded that the proposed use of some the paraquat containing

substances results in negligible/low risks to human health and the environment, when

appropriate controls are in place, and that the potential benefits were significant and non-

negligible. The EPA suggested that the overall benefit provided by the use of these paraquat

containing substances would outweigh the adverse effects, with the implementation of the

identified changes to controls.

3.7 The EPA update report noted that two of the approved substances triggered additional

Carcinogenicity, Mutagenicity or Reproductive Toxicity (CMR) hazard classifications, which

were triggered by co-formulants, such that these substances are associated with additional

risks. The EPA proposed in the application for reassessment that the inclusion of CMR

triggering components did not provide any additional benefit which might outweigh the

additional risks associated with these substances when compared to other paraquat-containing

2 For Para-Ken 250 (application APP202697)


December 2019

substances with similar use patterns. As no information was provided in the submissions which

the EPA considered to illustrate increased benefits provided by these substances, the EPA

maintained its proposal to not re-approve these two approvals.

3.8 The application and the EPA update report also noted that there were two approvals for which

there were no registered products under the ACVM Act and therefore these approvals were not

used. As no information was provided indicating the use or intention for use of these

substances, the assessment in the EPA update report was that no benefits were associated

with these approvals, while still having non-negligible risks, and therefore the proposal to not

re-approve these two approvals was maintained.

4 Hearing

4.1 On 11 and 12 September 2019, a hearing was held at Chartered Accountants – Wellington in

Wellington. Presentations were given by the EPA as the applicant, the Sapere Research Group

(Sapere), as an economic consultant on behalf of the EPA, and seven submitters.

4.2 One speaker, Stephen Salter, presented as part of Market Access Solutionz Limited (also

presenting on behalf of Potatoes New Zealand (Potatoes NZ) separately) which represented

the grower groups: Summerfruit New Zealand, Vegetables New Zealand, Process Vegetables

New Zealand, The New Zealand Buttercup Squash Council, and Onions New Zealand.

EPA presentation

4.3 The paraquat reassessment application was presented by representatives from the EPA.

4.4 They provided an overview of the history of paraquat as a herbicide, its regulatory history both

in New Zealand and in other jurisdictions, and the background to this application. The EPA

indicated that they had refined their initial risk assessments and resulting proposals based on

information provided in the submissions and call for information.

4.5 The EPA presented information on the risk assessment, outlining the changes in consideration

between this risk assessment and the risk assessment for application APP202697. The EPA

highlighted that there was a significant increase in data available from the call for information

compared to the more limited data set available for APP202697.

4.6 The EPA acknowledged that the initial approach was based on the methodology and endpoints

used for APP202697 which were subsequently refined following the provision of information

from Syngenta regarding the risk assessment to birds and aquatic plants. The changes to the

risk assessment were primarily concerned with the rapid adsorption of paraquat to sediment,

reducing the bioavailability of paraquat in the environment. This led to a decrease to the risks

associated with aquatic plant ecotoxicity and a reduction in the proposed buffer zone controls.

4.7 Regarding the revision of the risk assessment, the EPA noted that they agreed with Syngenta’s

proposed methodology but disagreed with the robustness of the studies used to produce the

acute and chronic toxicity endpoints. Instead the EPA selected a different endpoint following

review of the available literature and the scenarios used in the risk assessment modelling.

4.8 The EPA outlined the methodology and modelling for the human health risk assessment, and

selection of appropriate Acceptable Operator Exposure Levels (AOEL), no-observed-adverse-

effect-level (NOAEL) and Risk Quotient (RQ) values. The EPA outlined that there had been a

reduction in several classifications, but this did not affect the risk assessment which was based

on AOEL and NOAEL factors.


December 2019

4.9 The EPA presented the outcome of risk assessment modelling at different application rates and

with different use patterns for the paraquat containing substances. In particular they noted that

the risks associated with inhalation toxicity were not as high as would be expected due to lower

exposure rates illustrated in biological modelling. The EPA concluded that the revised

modelling indicated that a maximum application rate of 600 grams of active ingredient per ha (g

ai/ha) would be acceptable for boom and knapsack spraying, with controls in place.

4.10 The EPA noted the key points of the ecotoxicity profile of paraquat, highlighting the toxicity of

paraquat to terrestrial and aquatic plants including high toxicity to algae, high toxicity to birds,

and ecotoxicity to bees via oral and dermal exposure. The EPA also noted that the substance is

not ecotoxic to soil dwelling organisms. The EPA noted that paraquat is highly persistent and is

notably immobile in the soil environment, effectively being deactivated in contact with soil with a

soil adsorption coefficient (KOC) value of 15,473 millilitres per gram of content.

4.11 The EPA noted the risk assessment position taken for APP202697 resulted in the acute and

chronic risks to birds being considered to remain outstanding (contributing to the decision to

decline that substance). The revised risk assessment for birds across the scenarios relevant to

use in New Zealand, based on Syngenta’s methodology, resulted in acute risks to birds which

were below the Level of Concern (LOC) for all scenarios, however the chronic risks remained

above the LOC for pre-emergence and lucerne use scenarios.

4.12 The EPA presented the cultural risk assessment, noting that it was informed by the human

health and environmental risk assessments. The cultural risk assessment highlighted the

persistence of paraquat in soil and waterways and the risk to birds as concerning to Māori. The

EPA also noted that the cultural risk assessment supported the proposal to decline approvals

which were classified as CMR toxicants, as well as the proposed WorkSafe restrictions on

handheld use and closed cab application methods.

4.13 The EPA noted the submissions received, recording a range of positions on the approval status

from people that wanted to ban paraquat outright, to people that supported the use of paraquat,

as well as the restrictions that had been proposed in the application form. The largest group

was represented by the submitters who supported the re-approval of paraquat but opposed the

additional controls that were proposed in the application form.

4.14 The EPA spoke to the benefit assessment, revised risk assessment and revised proposals for

changes to the approvals and controls for paraquat herbicides. The EPA noted the economic

benefits case as prepared by Sapere, relating this to the different possible application rates

proposed, with a 600 g ai/ha application rate having the least impact on GDP while significantly

mitigating risks. The EPA spoke to the different benefits associated with different use patterns

and related this to their proposed use pattern restrictions.

4.15 It was highlighted that the significant benefits provided by biosecurity use are to be

incorporated into the proposed use patterns, and that forestry did not appear to be a significant

sector of use. The EPA set out that they were maintaining their proposal for mandatory

responsible handling requirements, highlighting that similar resources were available in other

jurisdictions. However, the requirement proposed in the application for completion of an

accompanying declaration of understanding would not be implemented. The EPA also stated

that any restrictions around handheld use would fall under the jurisdiction of WorkSafe rather

than the EPA.


December 2019

Committee questions

4.16 The Committee asked the EPA to clarify the relationship of the acute toxicity of paraquat with

its associated human health risks. The EPA responded, clarifying that the acute toxicity

inhalation value is derived through a study methodology and that value is not likely to be

achieved in the practical use of the substance, and that the oral and dermal exposure routes

may be more relevant, but also adding that systemic damage to the lung was the route for

toxicity. The EPA clarified that the risks account for various factors in addition to the hazard

classification, and that different substances cannot be compared for risk based on hazard

assignment.

4.17 The Committee asked if the EPA could provide some comment on the history of medical

incidents associated with the use of paraquat in New Zealand and if there was any comparison

with other herbicides. The EPA noted that the majority of incidents related to accidental

exposure or an end user not using the appropriate personal protective equipment (PPE). They

identified one or two overseas cases where the substance leaked from equipment and the user

was not wearing adequate PPE such that there was sufficient dermal exposure and absorption

to cause an effect.

4.18 Furthermore, it was noted that New Zealand coroner data suggests that paraquat poisonings

have decreased since the Act came into force. The EPA staff highlighted that a number of the

proposed controls, such as the requirement to include emetic and stenching agents, are

designed to mitigate accidental poisoning situations. The EPA also noted that a significant

proportion of poisonings in the recorded data were intentional. The EPA acknowledged that

they do not have any comparative data for other herbicides of similar use.

4.19 The Committee then asked for clarification regarding the exposure risks to birds. The EPA

responded clarifying that this was the chronic risk to birds, with the acute risk being below the

LOC for all proposed application rates. The EPA outlined that the chronic exposure risk occurs

via consumption of contaminated matter, being seeds, insects and other food sources and that

this was assumed in the modelling where the effect being modelled is essentially chronic

exposure from a single spraying event.

4.20 The EPA also noted that the exposure of birds to the substance would be determined by its

bioavailability, where binding with soil significantly limits the bioavailability. The EPA noted that

to release paraquat from the soil requires significantly extreme conditions to destroy the soil

such that the long term half-life is unlikely to result in longer term risks to birds foraging on the

ground in an area that has been sprayed. The Committee requested information on whether

such conditions would be present in a bird’s stomach and what the lifetime of ingested paraquat

material would be. The EPA noted these questions and deferred answering these to Syngenta

as the intellectual property owner who may hold this information, or to the EPA’s right of reply

later in the hearing.

4.21 The Committee asked what evidence there was for paraquat accumulating in bird food sources

to justify an assumption of 70% of food being the major exposure pathway in the modelling, and

whether there was evidence of biomagnification or bioaccumulation. The EPA acknowledged

that there was an absence of information on birdlife habits in New Zealand and therefore the

assumption that at the relevant points that birds would be foraging in the area and consuming

material. The EPA noted these questions and deferred answering these to Syngenta as the

intellectual property owner who may hold this information, or to the EPA’s right of reply later in

the hearing.


December 2019

4.22 The Committee questioned why a maximum application rate of 600 g ai/ha was proposed

where this would exceed the LOC for chronic risks to birds. The EPA explained that the

estimated level of risk in the revised risk assessment for an application rate of 600g ai/ha was

below the level of risk estimate accepted for an application rate of 400 g ai/ha in the original

application risk assessment. Therefore, it was considered that if level of risk was acceptable in

the application, a lower level of risk should be acceptable in the refined assessment.

Furthermore, the EPA noted that the additional application rate provided a significant economic

benefit increase which was considered to offset the risks associated with the increased

application rate. The Committee noted that there were further concerns to be addressed in the

area of the bird risk assessment.

4.23 The Committee requested clarification on the use sectors for the substance, notably whether

forestry is proposed to be included, and on the definition of horticulture vs ornamental

horticulture. The EPA clarified that there was little to no forestry use noted in the call for

information or submissions and therefore it was considered that paraquat provided little to no

benefit in this area.

4.24 The EPA also clarified that it was intended for the agriculture definition to incorporate forestry,

nurseries and production style horticulture, including ornamental horticulture which they

proposed had similar use patterns as agriculture, however noting the intent to exclude

horticulture in public amenity spaces and home use. The Committee noted that horticulture is

broadly quite a different use pattern and that the use patterns would need to be well defined.

4.25 The Committee observed the lack of iwi submissions considering there was a significant

cultural assessment, and that there would have been an expected input in both the cultural and

economic spaces from Iwi.

4.26 The Committee queried if the KOC values applied to all soil types. They continued, asking

whether paraquat may be released under anoxic conditions during runoff events or other

situations where the material may enter a lake or aquatic system. They asked if waterbodies

with stratification such that there are low Dissolved Oxygen and anoxic soil conditions which

result in a low pH and redox potentiality changes may cause a possible release of material. The

EPA noted that their information indicated that paraquat binds extremely well to aquatic soils,

and that further information would be provided in the right of reply.

4.27 The Committee queried the proposed use of the substances under a permission for biosecurity

and whether this may involve higher application rates in order to be effective for this use

pattern, with these uses assessed on a case by case basis. The Committee highlighted that

there may be issues with the practicalities of WorkSafe assessments for these uses. The EPA

confirmed that there may be some issues regarding the setting of WorkSafe requirements,

however, they otherwise considered that the Permission control would allow them to assess the

specific risks and benefits of any operation on a case by case basis.

Submitter questions

4.28 Stephen Salter (on behalf of Market Access Solutionz Limited) noted that the EPA had

referenced the Australian Pesticides and Veterinary Medicines Authority (APVMA) Australian

risk assessment for paraquat and noted that the conclusion of this decision was that no

available data impacted the approval status of paraquat in Australia.

4.29 Mr Salter noted that the permission control as applied to sodium nitrate baits does not require a

permission for use on DoC controlled land, and wondered if a similar arrangement was

considered with MPI, either in general or where the proposed use meets the controls assigned


December 2019

to paraquat containing substances for agricultural uses. The EPA acknowledged that they had

not considered delegation but noted that they would be reluctant to delegate the sign off

responsibility if the Committee were to allow permissions for biosecurity use as they would want

to ensure that the environmental and human health expertise was present to assess deviations

from the risk assessment and mitigations set for agriculture.

4.30 Mr Salter requested that the Committee and the EPA clarify what a non-target plant is in the

decision controls to avoid inadvertent non-compliance, as well as clarifying whether forestry

nursery use is included in the definition of agriculture. The Committee acknowledged the first

request and the EPA staff responded to the second clarifying that they considered forestry

nursery use much more akin to agriculture and would be included in that definition while

plantation use would be excluded. The EPA noted the uncertainty around the use control and

noted that more specific additional statements could be provided to give regulatory certainty.

Sapere presentation

4.31 Sapere presented the economic analysis commissioned by the EPA. They outlined the scope

of the assessment, this being an estimation of the economic contributions of paraquat and the

effect of different restriction scenarios, primarily application rates and use patterns, from

minimal restriction to a total ban on paraquat, and the effect this would have, with GDP being

the measure of data.

4.32 Sapere explained that GDP was chosen as the data are readily available, easy to understand

and comparable to other studies. This approach used a New Zealand Institute of Economic

Research (NZIER) study which estimated the contribution of different crops to GDP as a base

point. From this point the contribution herbicides provided to crop yield was factored based on

an American study which was subsequently adapted to New Zealand conditions and then

factored by the proportionate role of paraquat. Sapere concluded that this resulted in a baseline

crop contribution from paraquat use of 39-75 million NZD per annum as value added income.

4.33 The assessment produced estimates of high and low scenarios which are based on the

percentage of herbicide value attributable to paraquat, and are considered a proxy for the

availability of substitutes or alternatives to paraquat. It was noted that for kūmara and lucerne

crops, the high and low values were the same reflecting the absence of alternative herbicides

to paraquat for these crops.

4.34 Sapere described the modelling of different scenarios based on application rate and frequency

restrictions which were used to ascribe benefits to the different use rates and which the EPA

could subsequently use to determine a balance between the risks and benefit for the

application rate restrictions. Sapere concluded that restriction to 300 g ai/ha application rate

would put 96% of the GDP estimate of paraquat at risk, while a 400 g ai/ha application rate

modelled about 33% of the estimated GDP to be at risk, while only around 2% of estimated

GDP was modelled to be at risk for a 600g ai/ha application rate.

4.35 Sapere outlined the assumptions and sensitivity analysis of the model as well as the

corrections and clarifications made for the model, based on the information provided by

submitters, and the effect these had on the modelling outcomes. It was noted that there was

little effect on the high value crops including kūmara, lucerne and clover. It was also clarified

that GDP acted as a measure of value added to the economy and this was chosen as the

modelling measure rather than the use of sales revenues.


December 2019

Committee questions

4.36 The Committee queried the value added for 600 g ai/ha uses noting that many use patterns

incorporated did not use that quantity. Sapere clarified that the values included all uses up to

and including 600 g ai/ha application rates and alternatively it can be considered that the use

patterns under the threshold are not affected and only those over that margin would lose their

value.

4.37 The Committee queried the application rate versus frequency values of some of the graphed

results. These were clarified by Sapere.

4.38 The Committee requested an explanation of the adaptation of the US study information to New

Zealand conditions. Sapere explained that an “island factor” was applied which acted as a

scalar to represent the different values of herbicides for different regions based on their

conditions. For Australia there was a factor of 1.45 while in New Zealand the factor was 0.46.

This scalar factor was then applied to the overall estimation equation. Sapere then undertook

sensitivity analysis on this factor to confirm its accuracy. Sapere also noted that the original US

study is a generic theoretical appraisal of the value of herbicides versus no herbicide use.

4.39 The Committee noted that there would be a variety of different inputs and different scenarios for

the use of paraquat and consequently a wide spectrum of scenarios for which the yield would

be impacted, leading to an expected greater confounding factor on the GDP and/or yield

modelled. The Committee noted that grower submissions may be able to assist here. Sapere

stated that their assessment applied the impacts of herbicides on different crop yields to

specific crops rather than across the board, however as there were no hard data on the share

of herbicides accounted for by paraquat for each crop type, this was applied across the board.

4.40 The Committee asked for clarification on the adjustment of the 2015 information to information

applicable to 2017. Sapere noted they originally used inflation rates and then upon consultation

with industry adjusted the GDP figures according to industry growth rates for different crop

sectors.

4.41 The Committee asked if Sapere was able to incorporate potential offsets from the use of

alternative herbicides or production methodologies, including organic production or production

in areas where paraquat is banned. Sapere noted the lack of hard data regarding different

alternatives to significantly justify altering the sensitivity analysis or any other results and noted

that any further analysis would require case studies or further primary research.

Submitter questions

4.42 Mr Salter questioned the accuracy of the GDP risks noting that a number of use scenarios are

captured as single application rates while the actual use is multiple applications at those rates

per year, such that the total application rate may exceed the proposed annual restriction.

Therefore he suggested that there would be GDP at risk which was not accounted for where a

single application was below the application rate restriction but the annual application rate

exceeded this. Sapere acknowledged that there may be some limitations to the analysis as the

original scope for which they requested grower information concerned a single application

annually.

4.43 Mr Parker (representing Federated Farmers and Market Access Solutionz) asked if the analysis

considered the effects on GDP for the livestock industries for clover and plantain growing

sectors. Sapere confirmed that their economic analysis incorporated the full production chain

including downstream effects of the crop as an input to GDP.

4.44 There were no further questions from submitters.


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WorkSafe presentation

4.45 WorkSafe presented a general overview of the WorkSafe regulations, priority of risk elimination

measures and the modification of controls using Safe Work Instruments (SWIs). WorkSafe also

provided commentary on the proposals made by the EPA, noting support for the decline of

approvals with additional hazards drawn from components other than paraquat.

4.46 WorkSafe then spoke to the proposed additional mitigation measures which may be applied by

way of an SWI, highlighting that the refined proposal had decreased the number of additional

mitigation measures. They indicated that the remaining proposed measures were closed cab

application and closed mixing and transfer system requirements. WorkSafe stated that they

would be seeking further information on the cost and practicability of these measures.

Committee questions

4.47 The Committee requested a further definition of closed cab technology and queried if any of the

Safe Work Instrument (SWI) measures were more defined. WorkSafe indicated that the

defining of any proposed SWI was still in progress and that they would be seeking and would

be open to information from industry which may assist in defining any requirements. The

Committee expanded on the question of SWI consideration noting the proposal for biosecurity

permissions to allow for use outside of the proposed restrictions on agricultural use. WorkSafe

stated that any controls set by WorkSafe either as prescribed requirements or SWIs would

apply regardless of the use type. They further stated that there may be concerns with increased

application rates or other uses where risks to workers may increase but noted that an SWI

would not be appropriate for a “one-off use” situation such as a permission.

Submitter questions

4.48 Antony Heywood from Horticulture New Zealand queried the presentation of death statistics

from hazardous substance use and whether there was any specific information regarding

paraquat. WorkSafe replied stating that they did not hold this information and clarified that with

deaths from chronic exposure it was difficult to assign specific exposures as being the trigger

for toxic effects.

Presentations by submitters

Federated Farmers (Ms Williams, and Mr Parker (Also spoke on behalf of Market Access Solutionz Limited))

4.49 Federated Farmers was the first submitter to present at the hearing. Ms Williams stated that

they had engaged Mike Parker, who has experience working for the Foundation for Arable

Research (FAR) to speak on behalf of their submission.

4.50 Mr Parker presented images depicting use of paraquat in the field, including an image of

paraquat application to clover seed crop in winter and commenting that the seed is very small

and the likelihood of any birds being present in areas where paraquat would be applied being

exceedingly remote.

4.51 The submitter then spoke to the advantages and use of paraquat. Mr Parker spoke to the uses

in clover seed production, plantain and lucerne, illustrating his comments with relevant images.

The submitter noted the effectiveness of paraquat in killing off weeds while only having a

knockback effect on clover, having a similar knockback effect with quick crop recovery in

plantain.


December 2019

4.52 The submitter noted that there were no alternatives for paraquat use in clover, plantain and

lucerne, noting that the closest alternative for plantains, dicamba, distorts the plant, while other

substances have phytotoxic effects on lucerne during the dormant stage of its lifecycle.

4.53 The submitter noted the importance of these crops to New Zealand as forage crops, noting that

plantain and lucerne were nitrogen fixing and that plantain was a low methane forage source.

Noting the benefits of these crops, Mr Parker suggested that there would be an increasing

effect on GDP moving forward.

4.54 Regarding the application rate, it was noted that 600 g ai/ha of paraquat was workable for

clover and plantain, and that it was the minimum rate required for efficacy with lucerne. The

submitter noted that lower rates were not sufficient to be effective and rates greater than 600 g

ai/ha would be preferred.

4.55 The submitter then spoke to his experience as a compliance certifier and the requirements and

controls imposed on the substance as well as the proposed additional controls and control

variations which may be set by both the EPA and WorkSafe. The submitter indicated that the

prescribed requirements including certified handler and PPE controls should be sufficient to

prevent exposures and additional controls are therefore not necessary and/or would not fully

eliminate the risks as intended. The submitter also noted that the formulations require

stenching agents and emetics and that the majority of recorded incidents related to intentional

misuse, absence of PPE or use outside of agricultural areas.

4.56 The submitter noted concerns around the definition of agriculture and that it would exclude

parks, golf courses, nurseries and that the intent should not prevent these uses.

4.57 Finally the submitter noted that paraquat plays a role in herbicide rotation to prevent

agrichemical resistance.

Committee questions

4.58 The Committee requested clarification that the use of paraquat on clover and plantain was for

seed crops only, which the submitter confirmed.

4.59 The Committee requested comment on the reliance on paraquat in New Zealand compared to

internationally, whether it is critical to the efficiency of the farming sector, what research had

been undertaken for alternative substances to paraquat and what published reference material

was available to support the lack of alternative substances for these use patterns. The

submitter highlighted the climate and soil conditions in New Zealand which contribute to weed

growth and the differences in the type of cropping being undertaken in other international areas

as key factors in the reliance on the herbicidal weed control.

4.60 Additionally, the submitter noted the proportionally greater importance of livestock agriculture to

New Zealand. The submitter was aware of research being undertaken but stated no

alternatives had been identified or were available. The EPA added to this point, noting that that

they were not aware of any published material and their assessment therefore focused on label

claims against similar weed types, furthermore, the submission responses indicated very

limited availability of alternatives for several uses.

4.61 The Committee asked about the uses in relation to the risks around birds, whether the use

and/or conditions would be likely to attract bird presence around the time of application or have

any effect on the likelihood of a bird to consume contaminated material. The submitter indicated

that the noise of application equipment would likely disturb the birds from being present in the

area during application, and that the substance dries quickly following application. They also


December 2019

indicated that the low application concentration on a smaller area scale (“probably 0.001 of a

gram per maybe half a metre”) would further reduce risks.

4.62 The Committee then asked what the timeframe was for paraquat to kill the plants. The

submitter indicated that it was dependant on the temperature with increased speed during

warmer months, with the mode of action affecting photosynthesis, and increasing efficacy when

photosynthesis systems are more active. In early spring it probably takes two-three days to

notice any browning.

EPA questions

4.63 The EPA noted that the submission for Federated Farmers indicated that the substance is used

as a desiccant on clover seed and requested information on when harvest would occur after

application. The submitter indicated that this would take place when the clover is mature and

would normally occur two-three days after application, but would depend on a number of

considerations including temperature, soil type and organic matter in the soil. The submitter

emphased to the Committee that growers took into account a number of considerations before

deciding to use any substance.

4.64 The EPA then asked about the number of applications which would be required or undertaken

from regeneration through to harvesting of clover seed, and if multiple applications are required

within an annual application rate limit of 600 g ai/ha, would they be able to use lower

application rates (e.g. 200 g ai/ha) multiple times or would a higher rate be needed per

application. The submitter stated that most growers would likely use one or two applications but

it would depend on the conditions of the area, weed growth and the weed spectrum/seed bank,

such that each grower would be different. They noted that there may be problems with using

lower application rates related to resistance management, so label rates would be used to

ensure an effective response.

Grower organisation presentations on behalf of Market Access Solutionz Limited's submission (Mr Salter (also spoke on behalf of Potatoes New Zealand), Mr De Bruin, and Mr Parker (also spoke on behalf of Federated Farmers)

4.65 Three presentations were made, one after each other, as part of a collective submission on

behalf of a number of different grower representative groups.

4.66 The first presentation concerned five horticultural grower groups, New Zealand Buttercup

Squash Council, Onions New Zealand, Processed Vegetables NZ, Summer Fruit New Zealand,

and Vegetables New Zealand. The submitter (Mr Salter) summarised their methods for

collecting information noting the significant response from some grower sectors such as

kūmara, and that they considered they could provide significant information to the decision

making process as a growers’ voice.

4.67 The submitter noted the contributions that the growing operations represented make to New

Zealand and in particular rural and regional specific activity, both in terms of economic benefit

but also regarding the employment and well-being of rural communities.

4.68 The submitter highlighted the benefits that paraquat provides to growers in these sectors,

including the substances rain fast, fast acting, contact and non-translocating properties, and

that the substance’s unique mode of action provides use in rotation to avoid herbicide

resistance.

4.69 The submitter then discussed the safe use of paraquat, with direct reference to poison centre

call data stating that the majority of calls are for improper use of paraquat or where an incident

has occurred with old equipment or containers of the substance. They also noted that outside


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of what the submitter has considered outlier years that there was a downward trend in all

incidents involving paraquat.

4.70 The submitter then addressed the risks to birds. The submitter noted a number of concerns

raised in the submission with assumptions made in the modelling. They highlighted that the

model assumes that weeds and weed seeds will be available as a food source, even when the

crop is unpalatable, whereas normal use patterns are undertaken early in the weed lifecycle

prior to seed generation to allow the substance to have a rapid effect.

4.71 The submitter also stated that the models do not appear to account for the substance not

translocating, such that the concentration of the substance in seeds would only occur from

contact with the herbicide spray. The submitter stated that these assumptions would mean that

residue unit dose used in the model would be greater than what would be available for

consumption for a bird. The submitter also suggested that using birds with similar diets to those

in the field in New Zealand would give a representative results in the modelling.

4.72 The submitter commented on the controls proposed by the EPA. The submitter supported the

more flexible approach to setting application rates, however noted that the proposed limit did

not allow for a number of use scenarios indicated by growers, in particular, worst-case

scenarios.

4.73 They also expressed concerns regarding the spray droplet size controls where, as a contact

herbicide, most growers used a finer spray to ensure coverage is achieved and the use of

paraquat is efficacious. The submitter noted that there was no problem envisaged with the

responsible handling provisions or buffer zone controls. Finally, the submitter noted that the

label change date is 24 months while the implementation period for the other controls was

proposed for 12 months, and that this may result in confusion for users. The submitter

proposed that the controls changes be aligned at 24 months.

4.74 The collective presentation then continued with Mr De Bruin presenting as a kūmara grower,

and as the chair of Vegetables New Zealand.

4.75 The submitter spoke to the importance of the kūmara industry to the Dargaville and Kaipara

areas noting that 80-90% of New Zealand’s kūmara comes from the area, with plants covering

2,000 hectares, with 200 people employed full time while there are a further 1,000 seasonal

workers – mostly local people, emphasising the importance to the local area.

4.76 The submitter noted the low tolerance of kūmara towards herbicides including paraquat, noting

that there was low tolerance for variance to the use pattern and spray timing which is

undertaken overnight so as to minimise the “burning” effect on the kūmara crop itself.

Furthermore, the submitter noted that the low tolerance of kūmara to herbicides meant that

there were no alternatives which would not kill the kūmara crop itself.

4.77 Speaking to the use pattern of paraquat on kūmara, the submitter noted there were little to no

birds present when they had sprayed, with the majority of bird life present on adjacent

paddocks with other uses, where greater seed would be present.

4.78 The submitter discussed the growth pattern of kūmara in relation to weed growth and chemical

control with herbicides. The submitter noted that the growing region for kūmara is prone to

conditions such that kūmara crops are highly vulnerable to weed growth resulting in low crop

yield and further weed bank development threatening subsequent years’ cropping.

4.79 The submitter also outlined why these conditions resulted in mechanical cultivation and weed

control not being feasible, further noting that hand weeding was only applicable in situations

where chemical weed control had already occurred. They noted that, with the exception of


December 2019

grass weed control, no further use of agrichemicals is required for kūmara following canopy

closure.

4.80 The submitter then summarised, noting that they only use paraquat when necessary and that

they are interested in using alternative methods of weed control where possible, and limit the

use of agrichemicals to where there is a critical number of weeds to control.

4.81 Mr Parker completed the collective presentation on behalf of vegetable growers other than the

kūmara growers already represented by Mr De Bruin.

4.82 Mr Parker outlined the use patterns of paraquat in combination with other weed control

methods for a number of crops. The submitter highlighted the usefulness of paraquat in hand

held knapsack spraying in that, as a contact herbicide, any off-target spray will only result in

minor damage to leaf tissue rather than translocating and killing the whole crop plant.

4.83 The submitter noted the importance of paraquat to resistance management, with a particular

emphasis on management of glyphosate resistance.

4.84 The submitter noted anecdotally that he had never seen birds in a paddock during spray

application, nor had he witnessed any bird death on his property.

4.85 The submitter noted the current risk mitigation methods including PPE and Growsafe

requirements and auditing, stating that these in combination with the use patterns would

mitigate the majority of risks associated with the use of paraquat in New Zealand such that

additional controls such as closed cab technology or closed mixing and loading technology for

hand use should not be mandatory. The submitter noted significant expense associated with

these risk mitigation measures.

4.86 Finally the submitter noted while that 600 g ai/ha would be acceptable as a maximum

application for their operations provided the timeframe was per crop or per season, with

mitigation from protective equipment, higher application rates should be acceptable.

Committee questions

4.87 The Committee noted the importance placed on paraquat by the presenters. The Committee

identified that similar crops may be produced by organic growers and that production still

appeared to be economically viable in areas where paraquat was not available. Therefore, the

Committee asked for comment on the implication that other methods of weed control may be

viable, noting that there was therefore room for innovation. Furthermore, the Committee asked

whether there would be risks to the vegetable industry and to food supply to the domestic

market if paraquat were removed. The submitters responded, noting that there are very few

organic operations and any production appears to be significantly limited in scale, with the

Committee noting that scale of production appears to be an issue which necessitates paraquat

use. One submitter noted that keeping the seed bank under control was an issue for organic

growers. The submitters also noted that there were differences in the soil and climate profiles

for those regions which made other herbicidal control regimes more successful, whereas the

climate and high organic content of soils in New Zealand resulted in a reliance on paraquat to

control weed growth.

4.88 The Committee then asked for comment on the timing and/or variability of paraquat use. The

submitters noted that the use of paraquat varies significantly and is dependent on a number of

different factors which the grower will account for. The Committee asked for further information

around the cropping season and the use of paraquat. The submitters noted that while kūmara


December 2019

has a single annual season, other crops would have multiple rotations in a year such that there

would be multiple crop cycles annually and therefore multiple inputs of paraquat.

4.89 The Committee queried whether the proposed application rate restriction would be an issue in

use. The Committee noted that this may create issues should an application rate control be set

per season rather than annually with diverse and potentially high use scenarios being

accounted for in different control scenarios. The submitter noted that it was after large rainfall

events where the use of the substance was critical for crops such as kūmara. The submitter

stated that if there was a number of these rainfall events such that the maximum application

rate was expended and weeds are left to grow then subsequent years will not allow for

sustainable cropping.

4.90 The Committee noted that there were a number of uses which were listed in the submitter’s

presentation which would not fit within a 600 g ai/ha limit and questioned what impact there

would be for those industries, noting that there were significantly higher uses for some crops

including perennial systems. The submitter noted that there was a lot of variability in the use

dependent on the conditions and that these higher uses were likely due to worst-case use

scenarios where a higher level of weed control is required.

4.91 The Committee then queried the submitter’s statements around droplet size noting that other

presentations had indicated that coarse droplets would be applicable. The submitter noted that

droplet size was applicable to drift and coverage but that there were a number of other factors

which also contributed to use and would need to be accounted for. The EPA noted in its

questions that they were not aware of use of finer spray droplets in general for herbicides and

that this may significantly affect the buffer zone sizes proposed to mitigate spray drift.

4.92 The EPA noted that for modelling the risks to birds the EPA followed the guidance outlined by

EFSA in addition to the refinements outlined by Syngenta in their submission.

EPA questions

4.93 The EPA asked about the use of paraquat on kūmara and queried how control was achieved

with methods other than increasing the application rate. The submitter stated that increased

rates are not used as they “burn” the kūmara plant, and any increase is minimal to cope with

hydrophobic issues without adversely affecting the plant.

Potatoes New Zealand presentation (Mr Salter (also spoke on behalf of Market Access Solutionz Limited’s submission))

4.94 The submitter (Mr Salter) began by outlining the scale of potato growing in New Zealand, noting

there are over 10,000 ha of planted potatoes, over half a million tonnes annual production and

around 2,500 people employed per year throughout the production chain. The submitter also

noted that the value of potatoes across the entire value chain has exceeded a billion dollars in

the most recent estimates. The submitter also noted that all fresh potatoes sold in New Zealand

are produced here.

4.95 The submitter then spoke to the use of paraquat on potatoes. The submitter noted that the

majority of sprayers use boom sprays, however, knapsack use is not uncommon. The submitter

stated that it is typically sprayed at the pre-emergent to emergent stage of crops, often with

medium nozzles. The submitter noted that use as a desiccant was very rare.

4.96 The submitter then noted the key advantages of paraquat including its role in resistance

management and herbicide rotation with paraquat having a unique mode of action, and its

mode of action as a contact only herbicide limiting phytosanitary risks to crops, especially those


December 2019

used for seed production which are more vulnerable to other alternative herbicides than mature

crops.

4.97 The submitter closed their presentation noting that the majority of the controls proposed by the

EPA were workable including buffer zones and the application rate limits, however there may

be issues with the droplet size restrictions. They also noted that they were in support of the

responsible handling information provisions.

Committee questions

4.98 The Committee queried the use of paraquat in resistance management and why diquat, with a

similar mode of action, is not used in this role. The applicant responded stating that for some

uses diquat is applicable, however for other uses such as use on kūmara, the damage from

diquat to the crop is significantly more extensive.

4.99 The Committee then queried the extent of work which has been undertaken to manage

potatoes without paraquat, and what work would be done should resistance to paraquat occur.

The submitters noted that a primary issue requiring the use of paraquat was the need to ensure

rotation was available to prevent resistance build up to other herbicides, and that an effective

rotation scheme was needed to prevent resistance in all herbicides involved in the rotation

including paraquat. The Committee noted that they would prefer if a comparable estimate in

value could be provided to account for the value of paraquat to herbicide resistance

management.

4.100 With no further questions the hearing was adjourned for the day to be continued on the

following day, 12 September 2019.

Horticulture New Zealand Presentation (Mr Heywood)

4.101 Horticulture New Zealand began their presentation by outlining the scope of their growers and

the industry value they represent, noting 5,000 commercial fruit and vegetable growers with an

industry value of around 5.5 billion dollars which includes exports to 120 countries. The

submitter (Mr Heywood) noted that 60,000 people were employed in the industry covering

130,000 hectares of land across the country.

4.102 The submitter noted their support for the statements issued in the other grower groups’

submissions.

4.103 The submitter emphasised that growers do comply with a hierarchy of controls when dealing

with hazardous substances and that Horticulture New Zealand would provide support to, and

work with, WorkSafe for any Safe Work Instrument.

4.104 Speaking to the application rate restrictions, the submitter supports the proposed application

rate control threshold of 600 g ai/ha, but would prefer that the rate is set seasonally rather than

annually to account for different rotations of vegetables being undertaken and the need to use

paraquat in response to weather events.

4.105 The submitter stated that they supported the use of hand-held applications as being essential

to allowing spot treatment and minimal chemical use for targeted application. The submitter

noted that a hierarchy of controls could be applied to mitigate the risks associated with the

substance.

4.106 The submitter stated that they do not agree with the proposal to revoke approvals which are not

currently in use. They argued that these approvals currently present no risk, and revocation

may present a future regulatory obstacle and reduce options for formulations which do not fit


December 2019

other existing formulation approvals. The submitter noted the high cost of the reassessment

and assessment process, both financially and in terms of the time required for development of

new chemistry, as well as the risks this presents to industry. The submitter noted the small size

of the New Zealand agrichemical market and the low incentive to develop new chemistry for

this market, such that it was important to maintain available tools such as paraquat which are

critical to grower operations.

Committee questions

4.107 The Committee asked the submitter to confirm their position regarding the maximum

application rate being seasonal rather than annual and noted that it was difficult to consider the

definition of need, and the difficulty in accounting for the apparent need of different industries

without clear evidence of this need. The submitter noted that the need was dependent on the

cropping scenario and would only reflect the needs of a specific situation and proposed that the

control should be a matter of confidence in good management practices.

4.108 The Committee noted that the submitter’s summary of risks around the approvals which were

not currently used was different to that of the EPA and queried the basis for this position. The

submitter responded stating that they did not want to close off the potential future benefits of

these substances and noting that it would come down to whether the hierarchy of controls

could manage any risks associated with the substances should they come into use.

4.109 The Committee asked the submitter to comment on the limitations that New Zealand growers

face in terms of access to chemistry compared to growers in overseas markets. The submitter

stated that, anecdotally, the toolbox in New Zealand was much more limited than that of

overseas markets and that this was believed to be constrained by the size of the market and

delays in the regulatory process.

4.110 The EPA then provided a point of clarification on the proposed revocation of approvals, noting

that the EPA considered there to be an inherent risk associated with the unused approvals as

the risk assessment for the existing products would indicate risks relevant to those substances

also. Further to this as there was no current use the EPA considered that these substances had

no benefits associated with them, and thus on a risk benefit balance it was considered that the

risks to maintaining the approvals outweighed the risks.

Syngenta presentation

4.111 The submitter noted that they had produced an additional presentation in response to queries

raised on the first day of the hearing and clarified with the Committee if it was acceptable to

present this as well as a presentation to their submission. The Committee consented to this.

4.112 The submitter outlined their participation in the reassessment including the submission of

studies and risk assessments during the call for information and submission stages of the

application.

4.113 The submitter spoke to the benefits associated with the use of paraquat and herbicides with

similar use patterns including its value in rotational herbicide use and the GDP contribution to

the New Zealand economy. The submitter noted the use of paraquat and glyphosate as “knock

back herbicides” and their use in conservation tillage to safeguard soil fertility, with

conservation tillage resulting in a 90% reduction in soil erosion.

4.114 It was noted that the mode of action of paraquat, which keeps the inactive root structure in

place, does not require cultivation resulting in retention of water and carbon storage in the soil.

The submitter noted that once sprayed, paraquat kills the weed and then becomes inactive in


December 2019

the soil, allowing for a rapid turnaround in planting and preparation of a paddock for cropping.

They noted that the use of this herbicide as opposed to hand weeding has a major impact in

reducing labour requirements.

4.115 The submitter then spoke to the role of paraquat in resistance management with particular

regards to glyphosate resistance. The submitter highlighted the use of double knock strategies,

where two consecutive applications are undertaken with different herbicidal modes of action,

such that any surviving weed is controlled preventing germination of weeds which may develop

increased resistance. The submitter noted that they had observed increased weed control and

better crop yields using these strategies. The submitter noted that there were increasing cases

of resistance to herbicide modes of action in weeds and that, with no new modes of action

being discovered, there was a necessity to ensure rotation through different modes of action.

4.116 The submitter outlined that they broadly supported the changes to the approvals and controls

proposed by the EPA. They noted that stenching and emetic agents are commonplace and

supported the entrenching of these in regulatory controls. Similarly they supported the provision

of responsible handling information, controls on wind speed at the time of application, and

restrictions on the transfer of products into unsuitable containers.

4.117 They also noted that there were data regarding spray droplet size which indicated that droplet

size is not critical to efficacy and that if this is required for regulatory control then it was

supported by Syngenta. Expanding on this point, the submitter stated that for a contact

herbicide a medium to coarse spray would provide better efficacy. The submitter noted that

they had run trials in Australia with contact herbicides targeting annual ryegrass as a difficult

weed to combat where efficacy was not sufficient. The submitter noted that for very coarse and

extra coarse spray there was a slight reduction in efficacy, but this was not considered to be

significant, and that coarse spray showed successful efficacy with both air induction and

conventional nozzles.

4.118 Syngenta stated that they supported the threshold of 600 g ai/ha as a maximum application

rate, but considered that this should be a single application rate limit as the substance binds

with the soil rapidly such that it is no longer bioavailable to birds. The submitter presented a

table of Soil Adsorption Coefficient (Kd) values around the adsorption of paraquat to different

soil types, noting that there was a strong trend for increased binding with increasing soil clay

content, however strong binding was observable for all soil types.

4.119 Addressing the possibility of bio-release of paraquat in a bird’s stomach, it was noted that the

conditions required for release of paraquat from soil required extreme acidity for a number of

hours which was not expected to be replicated in a bird’s stomach. Moreover, the applicant

noted that the toxicity information from feeding studies using contaminated material indicated a

significantly lower toxicity than acute studies, such that a release of paraquat is not being

observed, and dietary consumption would be expected to result in a greater exposure or risk to

the birds. Therefore, single exposure was considered to be the main point of concern.

4.120 The submitter continued, addressing the possibility of bioaccumulation or biomagnification,

noting that the substance has a low octanol/water partition coefficient, with a log POW of -4.5,

making it significantly more soluble in water than fat and unlikely to bioaccumulate (with the

regulatory threshold for bioaccumulation being considered to be log POW of ≥+3). They also

noted that in the metabolism studies for rodents and dogs there was a low absorption and

bioavailability observed, with the studies illustrating that the substance is rapidly distributed

through the body tissues and rapidly eliminated within 72 hours, with more than 90% eliminated


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in a short period. Finally the submitter noted that the deactivation of paraquat in soil particles

resulted in limited bioavailability.

4.121 The submitter then presented information on the development of their closed system

technology with regards to the consideration of Safe Work Instruments regarding this

technology. The submitter spoke to the benefits of this technology and addressed concerns

around the cost and whether mixing would still be required, and the integration of this

technology into existing tools.

Committee questions

4.122 The Committee noted that Syngenta supported the application rate limit for a single application

but did not propose this as a maximum over a time period. The submitter stated that there was

strong evidence for limited chronic effects associated with paraquat use, noting that a number

of long-term studies on the effects of paraquat over ten or more years had been undertaken in

different locations around the world, which illustrated a limited chronic effect. The Submitter

noted that the substance binds to the soil, with strong data to illustrate that it is not bioavailable

and that, if released from the soil, it rapidly breaks down with a short half-life.

4.123 Furthermore, studies on the equilibrium of paraquat in the soil and bore water illustrate that

there is a significantly limited effect. Therefore, providing the substance was used judiciously

according to the standard use pattern, the substance would not lead to a cumulative effect. The

submitter also noted that the bird data on repeat dose of consumption provide an endpoint

which supports multiple uses of paraquat at a 600 g ai/ha single application rate.

4.124 The Committee asked for further information around resistance management and what the

response would be if resistance develops to paraquat. The submitter noted that rotation would

become more important in that scenario, with rotation used to protect different chemistries and

modes of action by slowing the rates of resistance. The submitter noted that new modes of

action (to be used in resistance management) were not currently foreseen. The submitter also

noted that there were issues with other technology developments to aid alternatives to

herbicide use and that these would have other impacts which would need to be balanced, such

as the effect on soil moisture and fertility.

4.125 The Committee noted that it was the inherently high acute risks from the substance that were of

main concern for the use of paraquat. The submitter agreed and noted that they supported

stringent measures to control the use of the substance including developing mitigation tools

that could be applied where PPE and other standard management options were not sufficient.

EPA and WorkSafe questions

4.126 The EPA asked if the submitter could clarify the relationship between crop protection use of the

herbicide and the use of paraquat as part of a herbicide resistance strategy. The submitter

noted that the two aspects were integrated and that there would be an agronomic need to apply

a substance for crop protection while the selection of what substance and how to apply the

substance would be a resistance management consideration.

4.127 The EPA asked if the long-term studies mentioned incorporated the effects on birds,

invertebrates, soil organisms and the wider spectrum of ecotoxicological events. The submitter

acknowledged that the studies focused on the accumulation in the soil, its availability and the

fate of paraquat in the soil environment. The submitter acknowledged that they were not aware

of whether other bio-indicators were used in this assessment.


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4.128 WorkSafe then asked if the submitter could outline the use of closed systems in Australia and if

there was any regulatory requirement for these systems. The submitter noted that this was not

yet a regulatory requirement, however there was an increasing trend towards the availability of

these technologies. The submitter also noted that there was coordination in the industry to

ensure that there were singular systems for these technologies rather than having different

systems designed for different products.

4.129 The EPA clarified that the application limitations around multiple applications were somewhat

derived from the inability to eliminate uncertainty from the modelling around multiple

applications. The resultant quantitative modelling showed some residual accumulated risks

which could not be accounted for quantitatively. While this may not represent the real world

scenario where multiple applications may be able to take place within a threshold, the

uncertainty around these risks could not be resolved. Therefore in order to maintain a level of

certainty around the risks, the EPA has proposed the annual limitation.

4.130 The EPA also noted that the responsible handling provisions were in part to account for the

long history of paraquat use, and to account for the associated complacency around the risks

associated with the substance, as well as highlighting the new requirements associated with

the substance.

4.131 This concluded the submitter presentations.

Applicant/EPA right of reply

4.132 The EPA clarified the intention of the proposed restriction to agricultural use, noting that they

intended that it would encompass cropping style situations, including production horticulture

with rows of ornamental plants grown for commercial purposes, and that there was an express

intent not to include use in places of public amenity or any home use scenarios which would be

considered to be a workplace because the substance was applied by a professional contractor.

4.133 The EPA then clarified the biosecurity permission provisions. The EPA highlighted the

submission from Biosecurity New Zealand indicating that the restrictions proposed for

agricultural use would not allow them to operate effectively. Biosecurity operations may provide

significant benefits, which may allow for a higher degree of risks to be acceptable but which

could also result in the application of additional or different controls which are not applied to

agricultural uses. The EPA noted that the permissions scheme would allow for the case by

case assessment of the benefits, risk tolerance and the setting of additional restrictions where

appropriate.

4.134 The EPA then addressed the phase in of controls, information provisions and labelling

requirements. The EPA noted that they considered a benefit in applying a 12-month phase in

period for the majority of controls and that they envisioned that users would be made aware of

new restrictions by the responsible handing provisions and through the use of additional

labelling items such as lid stickers to alert users to any changes.

4.135 Speaking to the risks to birds, the EPA considered there to be unmitigated chronic risks. The

EPA acknowledged the submitters’ anecdotal evidence regarding bird presence in application

areas, noting that these were anecdotal observations. They also noted that DoC submitted that

birds and other wildlife would be present in cropping and horticulture areas, however they noted

that these were again anecdotal observations. The EPA noted a shortage of literature relating

to birds and their living habits in agricultural environments, such that determining the type and

number of birds present would require more detailed observation.


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4.136 The EPA continued, noting that Syngenta submitted that multiple applications would behave as

a series of single applications without accumulated effect, and stating that the EPA disagreed

with this assessment. It was noted that the study where this was undertaken involved feeding of

a paraquat treated food supply, and that where paraquat was applied with multiple applications

the food supply for birds (insects and seeds) would receive continual dosing on each additional

application and therefore the risk assessment was refined to account for the proportion of bird

diets which would be contaminated at the time of year paraquat is typically applied.

4.137 The EPA noted that the risks associated with allowing multiple applications at up to 600 g ai/ha

per application were considered to outweigh the benefits that would be associated with allowing

multiple applications at this application rate under this risk assessment.

Committee questions

4.138 The Committee requested that the EPA ensure that the definition of horticulture is clarified to

ensure that the intended exclusion is accurately captured, whether this involves excluding

amenity horticulture or specifying that the definition is intended to include floriculture.

4.139 The Committee requested clarification on whether the application rate is proposed as annual or

seasonal. The EPA highlighted that some crop rotations may involve multiple rotations within a

single year such that a seasonal definition would allow for significantly higher use rates such

that the intended risk mitigation is not achieved. The EPA stated that it would not be simple or

effective to set different controls for different use patterns or more complicated controls which

allowed for flexibility with restriction over a greater time period, and furthermore to do so would

require a complicated and extensive risk assessment. Therefore, the EPA supports an annual

application rate restriction.

4.140 The Committee requested clarification around the chronic risk studies for birds. The EPA

responded, outlining that the studies are performed over a long period of time in which the

parent birds are fed contaminated food, equivalent to a repeat chronic exposure and the study

accounts for effects other than just the survival of the birds.

4.141 At this point there were no further questions or presentations.

4.142 The hearing was adjourned on 12 September 2018. After clarifying a number of outstanding

points with the EPA (discussed in the Post hearing considerations section below), the

Committee closed the hearing on 14 October 2019.

Post hearing considerations

4.143 The EPA contacted the Committee requesting direction or confirmation on a number of points.

4.144 Regarding the definition of agriculture, specifically ensuring the allowance for horticulture

outside of public amenity areas, the Committee directed the EPA to have the definition of

agriculture worded as follows:

“agricultural purposes includes use for agricultural and production horticulture purposes, but

does not include use for forestry plantation or biosecurity purposes. Production horticulture

includes commercial cropping systems and commercial ornamental horticulture production, but

excludes amenity horticulture in publicly accessible areas or horticulture areas which would

otherwise be considered domestic properties.”

4.145 The committee also received questions from a submitter regarding assumptions in the

modelling which were identified but not considered by the applicant to have been addressed by

the EPA in the hearing. The Committee directed the EPA to prepare a response to these

questions and reviewed this response but noted that they had sufficient information to proceed


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with a decision. This response was addressed in a minute from the Committee “Addendum to

WGT0001: direction & minute”.

4.146 The Committee considered whether further definition and direction was required from the

Committee regarding the scope and direction for permissions for biosecurity uses and whether

the Committee should engage with Biosecurity NZ on these matters. The Committee

considered that the proposed wording of the control and its reference to the Biosecurity Act

provided sufficient direction and that further consultation or assessment from the Committee

was not required on this matter.

4.147 The Committee considered the need to issue a direction for disposal for substances which are

proposed to have their approvals declined by the reassessment decision. The Committee

considered that a clear direction should be issued on this matter but that the details and

enactment of this process could be undertaken separately to the decision process.

5 Consideration

Information available for consideration

5.1 The information available to the Committee for consideration of this application consisted of:

the application form

the EPA update report

the submissions

information received from WorkSafe

previous EPA risk assessments

updated EPA risk assessment specific to this reassessment

EPA cultural assessment

hearing presentations made by the EPA and the submitters

addendum to hearing WGT0001: direction & minute.

5.2 After considering all relevant information, the Committee decided that it had sufficient

information to make a decision on this application. Further comments on this information can be

found below.

Hazardous properties

5.3 The hazardous properties of paraquat have been revised since the original application as new

information was available to inform a review of the hazards. The updated classification of

paraquat is summarised in Table 1 below. The classifications of paraquat-containing

substances are consequently also updated and the updated classification for the retained

approvals are shown in Tables 2 and 3 below.

Table 1 Hazard classifications of paraquat (HSR003041)

Hazard Classification

Acute toxicity (oral) 6.1C

Acute toxicity (dermal) 6.1E


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Acute toxicity (inhalation) 6.1A

Skin irritancy/corrosivity 6.3B

Eye irritancy/corrosivity 6.4A

Target organ or systemic toxicity (oral) 6.9A

Aquatic ecotoxicity 9.1A

Terrestrial vertebrate ecotoxicity 9.3B

Terrestrial invertebrate ecotoxicity 9.4B

Table 2 Hazard classifications of Soluble concentrate containing 115 g/litre diquat as the

dibromide salt and 135 g/litre paraquat as the dichloride salt (HSR000447)


Acute toxicity (oral) 6.1B

Acute toxicity (dermal) 6.1B


Skin irritancy/corrosivity 6.3A


Contact sensitisation 6.5B



Terrestrial vertebrate ecotoxicity 9.3A



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Table 3 Hazard classifications of Soluble concentrate containing 200 - 250 g/litre paraquat as

the dichloride salt (HSR000828)


Acute toxicity (oral) 6.1C

Acute toxicity (dermal) 6.1E


Skin irritancy/corrosivity 6.3A




Terrestrial vertebrate ecotoxicity 9.3B


Proposed modification of controls

5.4 The suite of controls proposed by the EPA, and considered by the Committee are detailed in

full in Appendix A of the EPA update report. The control suite includes:

prescribed controls, that is those triggered by the hazard classifications of paraquat and

the other excipient components in paraquat-containing substances

variations to the prescribed controls in accordance with section 77 of the Act

additional controls, proposed in accordance with section 77A of the Act.

Assessment of risks

5.5 The Committee took into account the EPA risk assessment for paraquat and

paraquat-containing substances, as detailed in the EPA update report. The key points are

summarised below.

Risks during manufacture, packaging, importation, transportation, storage and disposal

5.6 The Committee noted that the risks during manufacture, packaging, importation, transportation,

storage and disposal will remain at a negligible level, given that exposure is unlikely to occur

and that the proposed controls and other legislative requirements will sufficiently mitigate the

risks associated with these stages of the substance lifecycle. These include the existing EPA

Notices around packaging, identification, emergency management and disposal of hazardous

substances, the Land Transport Rule 45001, Civil Aviation Act 1990, Maritime Transport Act

1994 and New Zealand’s health and safety at work requirements.

Risks during use

5.7 The Committee noted that there is the potential for exposure to humans and the environment to

occur during the use phase of the substance and considered the human health and

environmental risk assessments provided by the EPA.


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Human health effects

5.8 The Committee noted that the predicted exposures during mixing, loading and application by

operators, and for bystanders for the agricultural use patterns at a maximum application rate of

600 g ai/ha, including aerial application with coarse droplets, resulted in risk quotients below

the acceptable operator exposure level (AOEL). The Committee noted that dermal exposure

during re-entry would not likely occur with the use patterns associated with paraquat and

therefore restricted entry intervals were not seen as necessary or modelled.

5.9 The Committee noted that the estimated bystander exposure from spray drift for aerial forestry

use is above the AOEL and would require a buffer zone. However the Committee also noted

that this use pattern would be excluded by the EPA’s proposed use restriction.

5.10 The Committee noted the conclusions of the science memo, that application rates up to and

including 600 g ai/ha using boom or aerial application methods are acceptable, providing that

full PPE including respiratory protection is used, whereas application rates above this rate

result in exposures exceeding the AOEL, even with full PPE. The Committee noted that

backpack application rates up to 390 g ai/ ha with full PPE and respiratory protection result in

exposures below the AOEL.

5.11 The Committee noted that the approvals HSR100443 and HSR100572, had formulations

containing components which would trigger additional CMR classifications which were not

triggered by paraquat. The Committee noted that these substances would present a higher risk

than the other substances subject to this reassessment. The Committee also noted that the

WorkSafe hierarchy of risks elimination suggests that these substances should not be used

where there is an alternative with a similar beneficial effect and that WorkSafe therefore

supported the revocation of these approvals.

Responsible handler provisions

5.12 The Committee considered the provision of responsible handling information requirements as

proposed by the EPA, noting that Syngenta supported this proposal in their submission. The

Committee noted the EPA’s justification around the long timeframe that paraquat has been in

use and that there may be some associated complacency and reluctance to uptake the new

requirements or update practices to safely use the substance. The Committee considered that

the responsible handling information provisions would assist in mitigating the human health

risks associated with paraquat and updating to safer use practices which are supported by the

other proposed controls.

Environmental effects

5.13 The Committee noted the conclusions of the science memo and risk assessment prepared by

the EPA.

Risks to the aquatic environment

5.14 The Committee noted that the predicted concentration of paraquat in the aquatic environment

without additional or varied controls is above the LOC. The Committee noted that additional

controls limiting the maximum application rate and applying use restrictions on droplet size

would reduce spray drift and reduce the risks to below the LOC.

Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators


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5.15 The Committee noted the EPA’s risk assessment conclusions that the risks to groundwater,

sediment-dwelling soil organisms and non-target arthropods are all below the LOC.

Risks to non-target plants

5.16 The Committee noted the risk assessment outcomes regarding non-target plants, where the

risks from spray drift are above the LOC. The Committee considered that the EPA’s proposal to

apply downwind non-target buffer zones to the product label would mitigate the risks to non-

target, threatened and non-threatened plants.

Risks to pollinators

5.17 The Committee noted the risk assessment conclusion regarding risks to pollinators, where the

risks to bees is above the LOC for all use patterns above an application rate of 100 g ai/ha,

however it also notes the qualitative conclusions that many of the use patterns are scenarios

where exposure to bees is expected to be minimal. Furthermore, the Committee notes that

clause 58 of the HPC Notice will apply such that any user must ensure that bees and non-

target pollinators are not in the application plot nor likely to visit the application plot.

Considering these factors, the Committee agreed with the EPA risk assessment conclusion that

the risks to pollinators would be mitigated to below the LOC with controls applied.

Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators

5.18 The Committee noted that there were unknown risks from the persistence of the substance in

the soil environment, including the effect on long-term soil fertility, and the effect on different

soil types. The Committee accepted that the soil persistence information needed to be generic

to cover risks with all soil types in New Zealand and therefore a conservative approach was

taken for this aspect of the assessment.

Risks to birdlife

5.19 The Committee noted the EPA risk assessment conclusion that the risks to birds are above the

LOC and are non-negligible. The Committee considered the risks to birds to be a key factor to

the overall ecotoxicology risk assessment, and the risk benefit assessment as a whole.

5.20 The Committee considered the issue of ecotoxicological risks to birds. The Committee noted

that there was a potential disconnect between the theoretical risk and the actual risks for birds.

The Committee acknowledged the perspectives provided by submitters which suggested that

the risks to birds seemed unlikely to exist, however they noted that the modelling undertaken by

the EPA still indicated a risk.

5.21 The Committee noted the lack of advocacy for birds in the submissions both written and heard

at the hearing compared to applications for similar substances. The Committee noted this may

result from a lack of resource to reliably quantify bird behaviour and the actual risks to birds

from a substance with known toxicity to birds and that this made the Committee’s position on

determining this risk difficult.

5.22 The Committee considered that the risk to birds was an outstanding risk which could not be

mitigated by the prescribed controls or the additional control set.

5.23 The Committee considered that, based on the balance of risks to birds to benefits, the

maximum annual and single application rate of 600 g ai/ha would be appropriate.


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

5.24 The Committee did not identify any risks to society, the community and the economy

associated with the approval of paraquat herbicides, other than those considered previously.

The Committee therefore did not consider this further.

Assessment of benefits

5.25 The Committee noted the benefits to communities and the economy raised in the application,

the EPA update report, and in the associated economic analysis, as well as the information

provided in the submitters’ subsequent questions, submissions and in submitter presentations.

5.26 The Committee noted that there were gaps in the assessments regarding aspects of benefits

on the community and the market economy. In particular, the Committee noted that there was

limited to no information on the regional impact of paraquat herbicides and there was little

information on organic agriculture and horticulture practices for the use patterns associated

with paraquat. The Committee considered that these were significant gaps in considering the

economic value and reliance on paraquat for different sectors.

5.27 The Committee noted the EPA summary that the majority of benefits were present in the

agriculture and horticulture sectors, and that the information from submitters indicated little

benefit from the use of paraquat in forestry plantations.

5.28 While the Committee acknowledged that there were absences in the information available, they

considered that there was sufficient information available regarding the use patterns for

paraquat to assert that the majority of uses would be covered by the proposed application rate

restriction of 600 g ai/ha as a maximum single and a maximum annual application rate.

5.29 The Committee noted the benefits outlined in the EPA update report and in the information

provided in the form of submissions. Furthermore, the presentations at the hearing from grower

and agricultural representatives demonstrated benefits of the use of paraquat herbicides. The

Committee noted that there were key benefits to specific agricultural industries from paraquat

and that the EPA and submitter presentations noted that there were few if any alternatives to

paraquat are available for these uses.

5.30 The Committee noted that there were benefits associated with biosecurity uses, that these

benefits were non-negligible, and that these may require application rates outside of the

restrictions applied to agricultural use. The Committee considered that these benefits could be

assessed against the associated risks through a permission under section 95A of the Act. The

Committee considers that biosecurity use of paraquat should only allow for those uses defined

under the Biosecurity Act 1993, by the relevant competent agencies as described under that

Act, and other interpretations of this use pattern should not be allowed. Therefore the

Committee considered that the permission control should directly reference the Biosecurity Act.

5.31 The Committee considered the proposed benefits and assessed them as non-negligible.

5.32 The Committee considered the substances where there were no registered products

(HSR007847 and HSR007854). The Committee noted that the originator of these approvals

supported the revocation of these approvals. The Committee therefore concluded that these

approvals have little to no benefit and that this should be accounted for in the assessment to re-

approve or decline these substances. The Committee considers that these approvals should

therefore be declined, with this to come into effect 12 months following the date of the decision.

5.33 The Committee considered the approvals which had CMR classifications which were not

triggered for the other approvals (HSR100443 and HSR100572). The Committee considered


December 2019

that these approvals did not provide any additional benefits when compared to the substances

proposed for re-approval. The Committee considers that these approvals should therefore be

declined, with this to come into effect 12 months following the date of the decision.

5.34 The Committee noted that the intellectual property owner for paraquat, Syngenta, supported

declining approvals in their submission.

Cultural assessment

5.35 The Committee noted that the EPA assessed the potential effects on the economic, social, and

cultural well-being of Māori, and the relationship of Māori to the environment, in accordance

with sections 5(b), 6(d) and 8 of the Act.

5.36 The Committee considered that with the controls proposed in place, the impact of use of

paraquat herbicides on the relationship of Māori to the environment would be negligible. The

Committee considered that the application is likely to be consistent with the principles of the

Treaty of Waitangi.

New Zealand’s international obligations

5.37 The Committee noted there were no international obligations regarding paraquat

Amendments to proposed controls by the Committee

5.38 In accordance with section 29 of the Act, the Committee took into account the proposed suite of

controls and noted that these aligned with best international practice for the mitigation of risks

posed to human health and the environment by hazardous substances.

5.39 The Committee did not consider any amendments to the controls proposed by any submitters.

5.40 The Committee considered that the setting of a maximum annual application rate and a

maximum single application rate of 600 g ai/ ha as proposed by the EPA would encompass the

majority of use patterns while, in combination with the other proposed controls, would mitigate

the majority of human health and ecotoxic risks, and therefore provide the best balance

between the non-negligible benefits and risks associated with the use of paraquat containing

substances.

5.41 The Committee determined that the controls detailed in Appendix A will apply as soon as this

decision is published or at the latest at the end of the transitional period specified in Tables A-1,

A-2, A-3 and A-4 in Appendix A.

5.42 The Committee noted that the controls for human health risks in a workplace, including any

associated Safe Work Instruments, are administered by WorkSafe rather than the EPA and

therefore were outside the scope of consideration. While these workplace controls ultimately

were not determinative of the Committee’s decision, the Committee expressly recommended

that requirements for closed systems should be adopted for handheld and closed cab wide

dispersive use patterns.

Direction to dispose of substances with declined approvals

5.43 The Committee have considered that substances with approvals which will be declined will

need to be disposed of once the decision comes into effect. The Committee consider that the

direction for disposal will be set out in a Notice in the New Zealand Gazette as required by s66

of the HSNO Act which will be issued subsequent to this decision. This direction to dispose will


December 2019

come into effect 12 months after the date of the decision when the effect of the decision to

decline these approvals takes effect.

Guidance on packaging requirements

5.44 The Committee noted that under the previous hazardous substances packaging regulations

(revoked), the packaging control for paraquat was varied to apply packing group III rather than

the packing group I. In the previous controls and decision it was noted that the oral and dermal

routes of toxicity, which have a lower classification, were more likely to be realised in this stage

of the substance’s lifecycle than the inhalation toxicity which triggers the higher 6.1A acute

toxicity classification, and therefore the packing group was set as packing group III to reflect the

level of risk associated with the applicable routes of toxicity. The Committee notes that under

the new Packaging Notice, which will apply as a prescribed control to any new approval, the

packaging requirements for the substance directly correspond to the Recommendation on the

Transport of Dangerous Goods Model Regulations which allow for paraquat to be packaged in

packing group I, II or III. The committee considers that packing group III remains appropriate for

paraquat and that this shall be illustrated in the following guidance note to be attached to the

packaging notices control:

“Guidance note: Paraquat may fall under Packing group I, II or III under the Recommendation

on the Transport of Dangerous Goods Model Regulations. The EPA considers that Packing

Group III is appropriate for paraquat containing substances.”

6 Conclusion and decision

6.1 Pursuant to section 29 of the Act and section 32 of the Hazardous Substances and New

Organisms (Methodology) Order 1998 (“the Methodology”), the Committee considered this

application to reassess paraquat and paraquat-containing substances. In doing so, the

Committee applied all the relevant sections of the Act, including those set out in Part 2, and

clauses of the Methodology, as detailed in Appendix B.

6.2 The Committee considered all the effects associated with the substances Paraquat

(HSR003041), Soluble concentrate containing 115 g/litre diquat as the dibromide salt and 135

g/litre paraquat as the dichloride salt (HSR000447) and Soluble concentrate containing 200 -

250 g/litre paraquat as the dichloride salt (HSR000828). The Committee considered that the

variations to the prescribed controls and the additional controls proposed by the EPA should be

applied to mitigate the risks associated with the substances. It is considered that there may be

non-negligible risks to birds associated with paraquat containing substances even with the

proposed control set and that these risks could not be managed with further additional controls.

The Committee considered that there are significant non-negligible benefits associated with

paraquat containing substances and that these benefits were sufficient to outweigh the risks

associated with the paraquat containing substances approved under Paraquat (HSR003041),

Soluble concentrate containing 115 g/litre diquat as the dibromide salt and 135 g/litre paraquat

as the dichloride salt (HSR000447) and Soluble concentrate containing 200 - 250 g/litre

paraquat as the dichloride salt (HSR000828). It was, therefore, considered that the positive

effects of paraquat containing substances outweigh the adverse effects and that these

substances should be approved under this reassessment.

6.3 The Committee considered that the paraquat containing substances Uniquat 250 (HSR100443)

and Parable 250 (HSR100572) triggered additional classifications which were triggered by

components other than paraquat, such that there are additional non-negligible risks to human

health associated with these substances. The Committee considered that there was no


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evidence to suggest that the inclusion of the components triggering these classifications would

provide any additional benefits to the use of a paraquat containing substance. They considered

that the non-negligible risks associated with these formulated substances would outweigh the

benefits and that the approvals for these approvals therefore be declined. The effect of this

decision comes into effect 12 months following the date of decision.

6.4 The Committee considered the proposal that those paraquat containing substances

(Gramoxone Inteon (HSR007847) and Preeglone Inteon (HSR007854)) which do not have any

products registered under the ACVM Act provided no benefits as they were not in use, and

agreed that there were negligible benefits associated with these substances. These substances

have non-negligible risks. The Committee therefore considered that the positive effects of these

substances were outweighed by the adverse effects and that the approvals should therefore be

declined. The effect of this decision comes into effect 12 months following the date of decision.

6.5 In making its decision, the Committee took into account best international practices and

standards for the safe management of hazardous substances.

6.6 Consequently, the Committee determined that the approvals Paraquat (HSR003041), Soluble

concentrate containing 115 g/litre diquat as the dibromide salt and 135 g/litre paraquat as the

dichloride salt (HSR000447) and Soluble concentrate containing 200 - 250 g/litre paraquat as

the dichloride salt (HSR000828) are approved with additional controls and that the approvals

Gramoxone Inteon (HSR007847), Preeglone Inteon (HSR007854), Uniquat 250 (HSR100443)

and Parable 250 (HSR100572) are declined. The effect of the decision to decline the approvals

Gramoxone Inteon (HSR007847), Preeglone Inteon (HSR007854), Uniquat 250 (HSR100443)

and Parable 250 (HSR100572) comes into effect 12 months after the date of this decision.

Signed by: Dr Ngaire Phillips Date: 12 December 2019

Chair, Decision Making Committee

Environmental Protection Authority


December 2019

Appendix A: Controls applying to retained approvals

The controls in Table A-1 are prescribed by the EPA Notices. The controls that have been varied by

section 77 of the Act are in Table A-2 and A-3 (Transitional periods for reassessed approvals). The

additional controls set under section 77A are in Table A-4 and A-5.

Table A-1 Prescribed controls for the retained approvals – HSR003041, HSR000447 and HSR000828

Control

code

Legislative

instrument

Control description Date of effect

LAB EPA Labelling Notice

2017

Requirements for labelling of

hazardous substances

24 months from decision date

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

Immediate

HPC-1

EPA Hazardous

Property Controls

Notice 2017 Part 1

Hazardous Property Controls

preliminary provisions

Immediate

HPC-2

EPA Hazardous

Property Controls

Notice 2017 Part 2

Certain substances restricted to

workplaces only

Immediate

HPC-3

EPA Hazardous

Property Controls

Notice 2017 Part 3

Hazardous substances in a place

other than a workplace

Immediate

HPC-4A

EPA Hazardous

Property Controls

Notice 2017 Part 4A

Site and storage controls for class 9

substances

Immediate

HPC-4B

EPA Hazardous

Property Controls

Notice 2017 Part 4B

Use of class 9 substances Immediate

HPC-4C

EPA Hazardous

Property Controls

Notice 2017 Part 4C

Qualifications required for

application of class 9 pesticides

Immediate

*Guidance note: Paraquat may fall under Packing group I, II or III under the Recommendation on the

Transport of Dangerous Goods Model Regulations. The EPA considers that Packing Group III is appropriate

for paraquat herbicides.

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Labelling-Notice-2017.pdf

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Labelling-Notice-2017.pdf

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Packaging-Notice-2017.pdf




https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Disposal-Notice-2017.pdf

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Disposal-Notice-2017.pdf

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Hazardous-Property-Controls-Notice-2017.pdf












December 2019

Table A-2 Additional controls applying to paraquat (HSR003041) under section 77A

Code Control Date of effect

Specification

of pesticide

and

veterinary

medicine

actives

Specification of pesticide and veterinary medicine actives

(1) Any person who—

(a) manufactures or imports into New Zealand this hazardous

substance, which that person has not previously manufactured

or imported on or before 1 July 2006; or

(b) had previously manufactured or imported this hazardous

substance on or before 1 July 2006, but that person has since

modified the manufacturing process or changed the source of

manufacture for that hazardous substance,

must provide to the Authority in writing the information required by

subclauses (3) and (4).

(2) The information required by subclause (1) must be provided—

(a) in the case of a substance that is manufactured in New

Zealand prior to that substance being sold to another person

or used in accordance with clause 1 of Schedule 3; or

(b) in the case of a substance that is imported into New Zealand,

prior to that substance being imported; and

(c) in the case of a substance to which subclause (1)(b) applies—

(i) each and every time the manufacturing process or

source of manufacture is changed; and

(ii) include equivalent information for the substance that was

produced by the manufacturing process before it was

modified, or supplied by the previous source of

manufacture, if such information has not previously been

provided to the Authority.

(3) The information to be provided is—

(a) the name and address of the manufacturer of the substance;

(b) the specification of the substance including either—

(i) the full name, including relevant citation, of the national

and/or international standard(s) set by an international

scientific or regulatory body recognised by the Authority

with which the substance complies, and evidence to

support this; or

(ii) the manufacturer’s specifications including purity of the

hazardous substance, isomeric ratio where applicable,

maximum impurity content and evidence to support

these, including details of analytical methods

used. Where the substance is produced at more than

one manufacturing site, this information must be provided

for each site separately;

Immediate


December 2019

(c) the identity of any impurity, its origin, and the nature of its

relationship to the active component—

(i) in the case of this substance, when the impurity is

present at a concentration of 10 g/kg or more;

(d) the identity of any impurity that is known to be of toxicological

concern, its origin, and the nature of its relationship to the

active component—

(i) in the case of this substance, when the impurity is

present at a concentration of less than 10 g/kg.

(4) Information on an impurity that is required under subclause (3) must

include—

(a) its chemical name;

(b) its Chemical Abstract Service Registry number (if available);

and

(c) its maximum concentration in the substance.

Use

restriction

Prohibition on use of substances

(1) No person may use this hazardous substance for any purpose other

than—

(a) for research and development; or

(b) as an ingredient or component in the manufacture of another

substance or product.

(2) Despite subclause (1)(a), research and development using this

substance does not include investigation or experimentation in

which the substance is discharged, laid or applied in or to the

outdoor environment.

Immediate

Table A-3 Transitional Period Relating to an approval that has been reassessed. Controls varied for all approvals under S77

Control

code

Legislative

instrument

Variation Date of effect

LAB EPA Labelling

Notice 2017

Transitional period relating to an approval that

has been reassessed

(1) A person relying on an approval that has been

reassessed, during the transitional period, must

comply with the controls in the approval related

to labelling—

(a) according to the terms of the approval as in

force immediately before the reassessment

decision; and

(b) as if any relevant regulations that were in

force under the Act immediately before 1

December 2017 remained in force

(whether or not they have been revoked).

Duration of the

Transitional

period: 11

December 2019-

11 December

2021

(24 months from

decision date)


December 2019

Control

code

Legislative

instrument


(2) For the purposes of this clause, the transitional

period is a period starting on [decision date] and

ending on [decision date + 24 months].

PKG EPA Packaging

Notice 2017


has been reassessed


reassessed, during the transitional period,


to packaging—



decision; and








Duration of the

Transitional

period: 11

December 2019-

11 December

2021

(24 months from

decision date)

SDS EPA Safety data

Sheets Notice

2017


has been reassessed


reassessed, during the transitional period,


to safety data sheets—



decision; and








Duration of the

Transitional

period: 11

December 2019-

11 June 2020

(6 months from

decision date)


December 2019

Table A-4 Controls varied for HSR000447 and HSR000828 under section 77

Control

code

Legislative

instrument


HPC-4B EPA Hazardous

Property Controls

Notice 2017 Part

4B – clause 50(1)

Use and application parameter restrictions

(1) From 11 December 2020, the following

application parameter restrictions are set for this

substance when used for agricultural purposes:

- Maximum single application rate = 600 g

(paraquat ion) / ha

- Maximum annual application rate = 600 g

(paraquat ion) / ha

(2) For avoidance of doubt, in (1)—

(a) agricultural purposes includes use for

agricultural and production horticulture

purposes, but does not include use for

forestry plantation or biosecurity purposes.

Production horticulture includes

commercial cropping systems and

commercial ornamental horticulture

production, but excludes amenity

horticulture in publicly accessible areas or

horticulture areas which would otherwise

be considered domestic properties. This

definition of agricultural purposes also

includes commercial forestry nurseries.;

(b) single application rate means the

quantity applied per unit area in a single

application event;

(c) annual application rate means the

quantity applied per unit area within any

calendar year.

Explanatory note: the Labelling Notice requires that

this information be provided on the product label.

11 December

2020

(12 months from

decision date)

HPC-4B EPA Hazardous

Property Controls

Notice 2017 Part

4B – clause 51

Downwind buffer zones

From 11 December 2020 when used for

agricultural purposes, 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 the respective

specified distance of a downwind sensitive area.

11 December

2020

(12 months from

decision date)


December 2019

Control

code

Legislative

instrument


Maximum application rate(AR)

g (paraquat ion) /ha

Application method Sensitive receptor AR ≤ 400 400 < AR ≤ 600

All ground-based

applications:

- excluding use of

non-motorised

handheld equipment

Aquatic organisms Nil 5 m

All aerial applications Aquatic organisms 5 m 15 m

Explanatory note: the Labelling Notice requires that this information be provided on the product

label.

LAB LAB Notice,

clause 25,

Label buffer zones

From 11 December 2021–

(a) a person must not supply this substance to

any other person unless the substance

label shows information detailing the

requirements set out in the below Table;

and

(b) a person who is in charge of this substance

must ensure that the packaged substance

is accompanied by a label that satisfies the

requirements of (a).

11 December

2021

(24 months from

decision date)

Maximum application rate (AR) /

g (paraquat ion) /ha

Application method Sensitive receptor AR ≤ 400 400 < AR ≤ 600

All ground-based

applications:

- excluding use of

non-motorised

handheld equipment

Aquatic organisms Nil 5 m

Non-target plants (non-

threatened)

Nil 5 m

Non-target plants

(threatened)

5 m 5 m

All aerial applications Aquatic organisms 5 m 15 m

Non-target plants (non-

threatened)

40 m 40 m

Non-target plants

(threatened)

60 m 100 m


December 2019

Table A-4 Additional controls for HSR000447 and HSR000828 under section 77A

Code Control Date of effect

Impurity

specification

Impurity specification

Any person who manufactures or imports into New Zealand must ensure

that the technical grade active ingredient used in this substance does not

contain the following impurities above the specified concentration:

- Total terpyridines: 0.001 g/kg (1.0 ppm) maximum;

- Free 4,4'-bipyridyl: 1.0 g/kg (1000 ppm) maximum.

Immediate

Requirements

for emetics

and stenching

agents

Requirements for emetics and stenching agents

No person shall pack for sale or supply this substance unless it contains

a stenching agent and an effective emetic, where:

- effective emetic means any substance that meets the

requirements of the Food and Agricultural Organisation of the

United Nations (FAO) publication Specifications and

Evaluations for Agricultural Products: Paraquat Dichloride,

2008;

- stenching agent means any substance that, when added to a

hazardous substance, imparts to that hazardous substance an

offensive stench that is readily distinguishable from the aroma

of any beverage, whether or not it is intended to serve that

purpose.

Immediate

Use

Restriction

Use restriction

(1) From 11 December 2020—

(a) no person can apply the substance except for agricultural or

biosecurity purposes; and

(b) the person in charge of the application must ensure that the

application is carried out in accordance with the requirements

of (1)(a).

(2) For avoidance of doubt, in (1)—

(a) agricultural purposes includes use for agricultural and

production horticulture purposes, but does not include use for

forestry plantation or biosecurity purposes. Production

horticulture includes commercial cropping systems and

commercial ornamental horticulture production, but excludes

amenity horticulture in publicly accessible areas or horticulture

areas which would otherwise be considered domestic

properties. This definition of agricultural purposes also

includes commercial forestry nurseries.

(b) biosecurity purposes means use for operations carried out

under the Biosecurity Act 1993.

11 December

2020 (12 months

from decision

date)


December 2019

Permissions Requirement to obtain s95A permission for use of paraquat for

biosecurity purposes

From 11 December 2020 no person may apply this substance for

biosecurity purposes unless that person first obtains a permission from

the Authority under section 95A of the Hazardous Substances and New

Organisms Act 1996.

11 December

2020 (12 months

from decision

date)

Application

methods

Restriction on method of application

From 11 December 2020 a person applying this substance must ensure

that the substance spray is delivered as a coarse quality spray for

ground-based application and coarse to very coarse droplets for aerial

application as classified by the American Society of Agricultural &

Biological Engineers (ASABE) droplet size classification scheme

(American National Standard ANSI/ASABE S572.1, March 2009).

Explanatory note: for both ground-based and aerial application, droplets

larger those specified may be used.

11 December

2020 (12 months

from decision

date)

Label

Statements

Label statements relating to use restriction, application method

controls and responsible handling information controls

LABEL STATEMENT 1


(a) a person must not supply this substance to any other person

unless the substance label shows information detailing the

requirements of the Use restriction control, clause (1); and

(b) a person who is in charge of this substance must ensure that

the packaged substance is accompanied by a label that

satisfies the requirements of control (1)(a).

LABEL STATEMENT 2



unless the substance label shows information detailing the

requirements of the Restriction on method of application

control; and



satisfies the requirements of (2)(a).

LABEL STATEMENT 3



unless the substance label includes a statement to the effect of

the following:

“Responsible Handling Information is available [location] and

that this information should be read and understood before

using this substance”; and


the packaged substance is accompanied by the label required

by (3)(a).

11 December

2021 (24 months

from decision

date)


December 2019

Provision of

responsible

handling

information

Responsible Handling Information package

(1) From 11 December 2020

(a) an importer or manufacturer of the substance must obtain or

prepare Responsible Handling Information;

(b) For the purposes of (1)(a), Responsible Handling Information

means a package of information that—

(i) includes details on responsible handling of the

substance; and

(ii) is sufficiently comprehensive to allow any person

handling the substance to be aware of their HSNO

obligations when handling the substance; and

(iii) contains information on responsible handling of the

substance throughout its entire lifecycle, including (but

not limited to) mandatory content topics detailed in (3);

and

(iv) is consistent with compliant use under the requirements

of the substance approval, and requirements specified

under HSW;

(c) any person importing or manufacturing the substance must

ensure that the information required by (1)(a) is —

(i) readily available and freely accessible to users, to the

extent that is reasonably practicable; and

(ii) in English and be able to be readily comprehended.

INTERIM ACCOMPANYING INFORMATION

(2) From 11 December 2020 until 11 December 2021 a person must

not supply this substance to any other person unless the substance

is accompanied by information that includes statements to the

effect of the following:

(a) “Responsible Handling Information is available [location] –

users should read and understand before use”;

(b) “Maximum application rate restrictions apply from [date]”

(c) “Use of paraquat is only permitted for agricultural purposes

from [date]”

(d) “Refer to the updated SDS”

CONTENT REQUIREMENTS OF RESPONSIBLE HANDLING

INFORMATION

(3) For the purposes of (1)(b)(iii), mandatory content requirements are:

Topic 1 – What has changed?

Any person importing or manufacturing the substance must ensure that

the information required to be provided is, to the extent that is reasonably

practicable, is current and includes—

(1) a summary of significant regulatory activity and any corresponding

changes; and

(2) details of when the changes identified in (1) take effect.

11 December

2020 (12 months

from decision

date)


December 2019

Topic 2 – Application restrictions


the information required to be provided includes details of application

restrictions, and guidance on how to comply with those requirements,

including (but not limited to):

(1) Application rate restrictions

(2) Application equipment restrictions

(3) Droplet size requirements

(4) Use purpose restrictions (ie agricultural or biosecurity use only)

(5) Requirement to obtain s 95A permission for biosecurity uses.

Topic 3 – Disposal


the information required to be provided includes details on how to

appropriately dispose of unwanted products or tank mixes.

Topic 4 – Spillages


the information required to be provided includes details on what to do in

the event of a spillage or other exposure event.

Topic 5 – Contact information


the information required to be provided includes contact information for

the importer or manufacturer for the purpose of responding to queries

relating to the paraquat-containing substance.

Topic 6 – Responsible handling Information


the information required to be provided includes:

(1) Information on the human health hazards and key exposure risks

associated with the paraquat containing substance and its intended

uses

(2) details of how users can handle the paraquat containing substance

safely and compliantly, throughout the lifecycle from storage to

disposal.

Topic 7 – Avoiding ingestion


the information required to be provided includes details of how to avoid

ingestion of paraquat, and actions to take in the event of ingestion.

Topic 8 – Protection of water bodies


the information required to be provided includes details of how to protect

water bodies from paraquat contamination, including (but not limited to)

buffer zone requirements.

Topic 9 – Protection of birds


the information required to be provided includes details of measures that

should be implemented to minimise risks to birds.


December 2019

Topic 10 – Protection of bees


the information required to be provided includes details of measures

necessary to protect bees.

Additional

labelling

requirements

Additional labelling requirements

(1) From 11 December 2021 —

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

person unless the substance label shows the following

statements (or equivalent):

(i) “Do not apply when wind speeds are less than 3 km/h or

more than 20 km/h as measured at the application site”

(ii) “Do not transfer this product into food or drinks

containers, or into unlabelled containers”



satisfies the requirements of (1)(a).

Note: Buffer zones and application parameter restrictions required to be

included on product labels [EPA (Labelling) Notice 2017]

11 December

2021 (24 months

from decision

date)


December 2019

HSW Requirements for all retained approvals

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 Regs 2.1 - 2.4 Workplace labelling of hazardous substance containers

HSW2-2 Regs 2.5 -2.10 Signage

HSW2-3 Reg 2.11 Safety data sheets

HSW2-4 Regs 2.12 - 12.14 Packaging

HSW3-1 Reg 3.1 Inventory

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

HSW4-1 Regs 4.1 - 4.4 Compliance certificates for certified handlers

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

HSW5-2 Regs 5.6 - 5.13 Emergency response plans

HSW13-1 Regs 13.3 - 13.4 Records of application for class 6 substances

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

HSW13-4 Regs 13.9, 13.11 Certain substances to be under personal control of certified handler or

secured

HSW13-7 Regs 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

HSW13-13

Regs 13.26 -

13.29, 13.34 -

13.37

Storage and segregation of certain class 6 or 8 substances

HSW13-14 Regs 13.30 –

13.33

Secondary containment requirements for class 6 and 8 pooling

substances

HSW13-15 Regs 13.34, 13.38-

13.39

Duty of PCBU to establish hazardous substance location and compliance

certificate requirements where certain class 6 or 8 substances present

HSW13-16 Regs 13.40 - 13.44 Separation of hazardous substance locations holding class 6 and 8

substances

http://www.legislation.govt.nz/regulation/public/2017/0131/latest/DLM7309727.html?search=ts_act%40bill%40regulation%40deemedreg_hazardous+substances*_resel_25_a&p=2









http://legislation.govt.nz/regulation/public/2017/0131/latest/DLM7366700.html



















December 2019

HSW13-17 Reg 13.45 Additional emergency management requirements for certain class 6 or 8

substances

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

HSW17-1 Part 17 Requirements for stationary container systems

HSW19-1 Part 19 Tracking hazardous substances







December 2019

Appendix B: Decision path

Context

This decision path describes the decision-making process for applications for a reassessment of

hazardous substances approvals. These applications are made under section 63 of the HSNO Act

and determined pursuant to s29.


December 2019

Decision path for applications to import or manufacture a hazardous substance, application made under section 63 of the Act and determined under section 29.

For proper interpretation of the decision path it is important to work through the flowchart in

conjunction with the explanatory notes.


December 2019

Explanatory Notes

Item 1: Review the content of the application and all relevant information

Review the application, the E&R Report, and information received from experts and that

provided in submissions (where relevant) in terms of section 28(2) of the Act and clauses 8,

15, 16 and 20 of the Methodology.

Item 2: Is this information sufficient to proceed?

Review the information and determine whether or not there is sufficient information available to

make a decision.

The Methodology (clause 8) states that the information used by the HSNO decision maker in

evaluating applications shall be that which is appropriate and relevant to the application. While

the HSNO decision maker will consider all relevant information, its principal interest is in

information which is significant to the proper consideration of the application; ie information

which is “necessary and sufficient” for decision-making.

Item 3: (if “no” from item 2) Seek additional information

If there is not sufficient information then additional information may need to be sought from the

applicant, EPA staff or other parties/experts under section 58 of the Act (clause 23 of the

Methodology).

Item 4 Sufficient?

When additional information has been sought, has this been provided, and is there now

sufficient information available to make a decision?

If the HSNO decision maker is not satisfied that it has sufficient information for consideration,

then the application must be declined under section 29(1)(c).

Item 5: (If “yes” from item 2 or from item 4) Identify the composition of the substance, classify the hazardous properties, and determine default controls

Identify the composition of the substance, and establish the hazard classifications for the

identified substance.

Determine the default controls for the specified hazardous properties using the regulations

“toolbox‟.

Item 6: Identify all risks, costs and benefits that are potentially non-negligible3

Costs and benefits are defined in the Methodology as the value of particular effects (clause 2).

However, in most cases these “values‟ are not certain and have a likelihood attached to them.

Thus costs and risks are generally linked and may be addressed together. If not, they will be

addressed separately. Examples of costs that might not be obviously linked to risks are direct

financial costs that cannot be considered as “sunk‟ costs (see footnote 1). Where such costs

arise and they have a market economic effect they will be assessed in the same way as risks,

but their likelihood of occurrence will be more certain (see also item 11).

Step 1: Identify all possible risks and costs (adverse effects) and benefits (positive

effects) associated with the approval of the substance(s), and based on the

range of areas of impact described in clause 9 of the Methodology and

sections 5 and 6 of the Act3. Consider the effects of the substance through its

3 Effects on the natural environment, effects on human health and safety, effects on Maori culture and traditions,

effects on society and community, effects on the market economy.


December 2019

lifecycle (clause 11) and include the likely effects of the substance being

unavailable (sections 29(1)(a)(iii) and 29(1)(b)(iii)).

Relevant costs and benefits are those that relate to New Zealand and those

that would arise as a consequence of approving the application (clause 14).

Consider short term and long term effects.

Identify situations where risks and costs occur in one area of impact or affect

one sector and benefits accrue to another area or sector; that is, situations

where risks and costs do not have corresponding benefits.

Step 2: Document those risks, costs and benefits that can be readily concluded to be

negligible4, and eliminate them from further consideration.

Note that where there are costs that are not associated with risks some of

them may be eliminated at this scoping stage on the basis that the financial

cost represented is very small and there is no overall effect on the market

economy.

Item 7: Assess each risk assuming controls in place. Add, substitute or delete controls in accordance with clause 35 and sections 77, 77A and 77B of the Act.

The assessment of potentially non-negligible risks and costs should be carried out in

accordance with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the Methodology. The

assessment is carried out with the default controls in place.

Assess each potentially non-negligible risk and cost estimating the magnitude of the effect if it

should occur and the likelihood of it occurring. Where there are non-negligible financial costs

that are not associated with risks then the probability of occurrence (likelihood) may be close

to 1. Relevant information provided in submissions should be taken into account.

The distribution of risks and costs should be considered, including geographical distribution

and distribution over groups in the community, as well as distribution over time. This

information should be retained with the assessed level of risk/cost.

This assessment includes consideration of how cautious the HSNO decision maker will be in

the face of uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate

scenarios for lower and upper bounds for the adverse effect as a means of identifying the

range of uncertainty (clause 32). It is also important to bear in mind the materiality of the

uncertainty and how significant the uncertainty is for the decision (clause 29(a)).

Consider the HSNO decision maker’s approach to risk (clause 33 of the Methodology) or how

risk averse the HSNO decision maker should be in giving weight to the residual risk, where

residual risk is the risk remaining after the imposition of controls.

See EPA report “Approach to Risk‟ for further guidance5

Where it is clear that residual risks are non-negligible and where appropriate controls are

available, add substitute or delete controls in accordance with sections 77 and 77A of the Act

to reduce the residual risk to a tolerable level. If the substance has toxic or ecotoxic properties,

consider setting exposure limits under section 77B. While clause 35 is relevant here, in terms

of considering the costs and benefits of changing the controls, it has more prominence in items

10 and 13

4 Negligible effects are defined in the Annotated Methodology as “Risks which are of such little significance in

terms of their likelihood and effect that they do not require active management and/or after the application of

risk management can be justified by very small levels of benefits.

5 http://www.epa.govt.nz/Publications/Approach-to-Risk.pdf


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If changes are made to the controls at this stage then the approach to uncertainty and the

approach to risk must be revisited.

Item 8: Undertake combined consideration of all risks and costs, cognisant of proposed controls

Once the risks and costs have been assessed individually, if appropriate consider all risks and

costs together as a “basket‟ of risks/costs. This may involve combining groups of risks and

costs as indicated in clause 34(a) of the Methodology where this is feasible and appropriate, or

using other techniques as indicated in clause 34(b). The purpose of this step is to consider the

interactions between different effects and determine whether these may change the level of

individual risks.

Item 9: Are all risks with controls in place negligible?

Looking at individual risks in the context of the “basket‟ of risks, consider whether all of the

residual risks are negligible.

Item 10:

(from item 9 – if “yes”) Review controls for cost-effectiveness in accordance with clause 35 and sections 77, 77A and 77B

Where all risks are negligible the decision must be made under clause 26 of the Methodology.

Consider the practicality and cost-effectiveness of the proposed individual controls and

exposure limits (clause 35). Where relevant and appropriate, add, substitute or delete controls

whilst taking into account the view of the applicant, and the cost-effectiveness of the full

package of controls.

Item 11: Is it evident that benefits outweigh costs?

Risks have already been determined to be negligible (item 9). In the unusual circumstance

where there are non-negligible costs that are not associated with risks they have been

assessed in item 7.

Costs are made up of two components: internal costs or those that accrue to the applicant,

and external costs or those that accrue to the wider community.

Consider whether there are any non-negligible external costs that are not associated with

risks.

If there are no external non-negligible costs then external benefits outweigh external costs.

The fact that the application has been submitted is deemed to demonstrate existence of

internal or private net benefit, and therefore total benefits outweigh total costs6. As indicated

6 Technical Guide „Decision making‟ section 4.9.3. Where risks are negligible and the costs accrue only to the

applicant, no explicit cost benefit analysis is required. In effect, the HSNO decision maker takes the act of

making an application as evidence that the benefits outweigh the costs. See also Protocol Series 1 „General

requirements for the Identification and Assessment of Risks, Costs, and Benefits‟.


December 2019

above, where risks are deemed to be negligible, and the only identifiable costs resulting from

approving an application are shown to accrue to the applicant, then a cost-benefit analysis will

not be required. The act of an application being lodged will be deemed by the HSNO decision

maker to indicate that the applicant believes the benefits to be greater than the costs.

However, if this is not the case and there are external non-negligible costs then all benefits

need to be assessed (via item 14).

Item 12:

(if “no” from item 9) Establish position on risk averseness and appropriate level of caution

Although “risk averseness‟ (approach to risk, clause 33) is considered as a part of the

assessment of individual risks, it is good practice to consolidate the view on this if several risks

are non-negligible. This consolidation also applies to the consideration of the approach to

uncertainty (section 7).

Item 13: Review controls for cost-effectiveness in accordance with clause 35 and sections 77, 77A and 77B

This constitutes a decision made under clause 27 of the Methodology (taken in sequence from

items 9 and 12).

Consider whether any of the non-negligible risks can be reduced by varying the controls in

accordance with sections 77 and 77A of the Act, or whether there are available more cost-

effective controls that achieve the same level of effectiveness (section 77A(4)(b) and clause

35(a)).

Where relevant and appropriate, add, substitute or delete controls whilst taking into account

the views of the applicant (clause 35(b)), and making sure that the total benefits that result

from doing so continue to outweigh the total risks and costs that result.

As for item 7, if the substance has toxic or ecotoxic properties, consider exposure limits under

section 77B.

Item 14: (if “no” from item 11 or in sequence from item 13) Assess benefits

Assess benefits or positive effects in terms of clause 13 of the Methodology.

Since benefits are not certain, they are assessed in the same way as risks. Thus the

assessment involves estimating the magnitude of the effect if it should occur and the likelihood

of it occurring. This assessment also includes consideration of the HSNO decision maker’s

approach to uncertainty or how cautious the HSNO decision maker will be in the face of

uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate scenarios

for lower and upper bounds for the positive effect.

An understanding of the distributional implications of a proposal is an important part of any

consideration of costs and benefits, and the distribution of benefits should be considered in the

same way as for the distribution of risks and costs. The HSNO decision maker will in particular

look to identify those situations where the beneficiaries of an application are different from


December 2019

those who bear the costs7. This is important not only for reasons related to fairness but also in

forming a view of just how robust any claim of an overall net benefit might be. It is much more

difficult to sustain a claim of an overall net benefit if those who enjoy the benefits are different

to those who will bear the costs. Thus where benefits accrue to one area or sector and risks

and costs are borne by another area or sector then the HSNO decision maker may choose to

be more risk averse and to place a higher weight on the risks and costs.

As for risks and costs, the assessment is carried out with the default controls in place.

Item 15: Taking into account controls, do positive effects outweigh adverse effects?

In weighing up positive and adverse effects, consider clause 34 of the Methodology. Where

possible combine groups of risks, costs and benefits or use other techniques such as

dominant risks and ranking of risks. The weighing up process takes into account controls

proposed in items 5, 7, 10 and/or 13.

Where this item is taken in sequence from items 12, 13 and 14 (i.e. risks are not negligible) it

constitutes a decision made under clause 27 of the Methodology.

Where this item is taken in sequence from items 9, 10, 11 and 14 (i.e. risks are negligible, and

there are external non-negligible costs) it constitutes a decision made under clause 26 of the

Methodology.

Item 16:

(if yes’ from items 11 or 15) Confirm and set controls

Controls have been considered at the earlier stages of the process (items 5, 7, 10 and/or 13).

The final step in the decision-making process brings together all the proposed controls, and

reviews for overlaps, gaps and inconsistencies. Once these have been resolved the controls

are confirmed.

7 This principle derives from Protocol Series 1, and is restated in the Technical Guide „Decision making‟.