taff update report: paraquat herbicides reassessment ......gramoxone 250 flash herbicide parable...

Staff update report: paraquat herbicides reassessment (APP203301)

23 August 2019

Staff update report for reassessment of paraquat herbicides (APP203301)

epa.govt.nz ii [email protected]

Contents

Contents ii

The Reassessment Process ................................................................................................................. 3

1 Summary of changes to proposals and any key decisions .................................................... 4

2 This document and background ................................................................................................ 9

3 Analysis of submissions .......................................................................................................... 10

4 Issues identified in submissions ............................................................................................. 12

5 Issues relating to human health and environmental effects ................................................ 15

6 Updates to benefits assessment ............................................................................................. 20

7 WorkSafe’s responses to submissions related to the WorkSafe report ............................. 21

8 Updates to proposed risk mitigation measures ..................................................................... 23

9 Overall evaluation and recommendation ................................................................................ 49

Appendix A Controls tables for retained approvals .................................................................... 51

Appendix B Updates to economic report ..................................................................................... 55

Appendix C Revised human health risk assessment ................................................................. 56

Appendix D Revised environmental risk assessment ................................................................ 66


epa.govt.nz [email protected] 3

The Reassessment Process

Hearing

STEP TWO: Reassessment application

Public submissions

Formal receipt of application

Gathering information

STEP ONE: Grounds for reassessment

Evaluation of submissions

Consideration

Decision

mailto:[email protected]


epa.govt.nz 4 [email protected]

1 Summary of changes to proposals and any key decisions

1.1 This document is the Update Report for the reassessment of paraquat and paraquat-containing

substances. The purpose of the Update Report is to provide responses to issues raised in

submissions, and to provide an update to the proposals detailed in the reassessment

application document.1

1.2 The following are the proposals in the application that remain unchanged:

propose to re-approve substances HSR003041, HSR000447 and HSR000828, subject to

additional restrictions;

propose to decline to re-approve substances HSR100443, HSR100572, HSR007847, and

HSR007854;

use primarily restricted to agricultural use, requiring spraying using coarse spray droplets for

ground based application and coarse to very coarse droplets for aerial application.

1.3 The following are the key changes to the proposals detailed in the application:

increase in maximum application rates from 400 to 600 g ai/ha, with buffer zones for the

higher application rate also specified;

introduce maximum annual application rate restriction of 600 g paraquat ion / ha (ie no more

than 600 g paraquat ion may be applied per calendar year / 365 day period). This allows users

to ‘split’ the 600 g allocation into multiple applications, offering a degree of additional flexibility;

remove prohibition on handheld use – this cannot be set under the Hazardous Substances

and New Organisms Act 1996 (HSNO), but some restrictions relating to handheld applications

are being considered by WorkSafe under the Health and Safety at Work Act 2017 (HSWA);

definition of ‘agricultural use’ proposed, to provide clarity over what use scenarios are included

in this term. Key difference is that forestry is now excluded on basis of lack of use in that

sector, which would require additional mitigation measures if included;

expand allowable uses to include biosecurity use, subject to obtaining s 95A permission which

could allow use outside of the standard ‘agricultural’ restrictions proposed;

re-title product stewardship control to refer instead to Responsible Handling Information

control;

remove requirement for users to include a declaration of understanding in their records of use

of the change of controls.

1.4 This report also includes further details on specific aspects of the proposals:

proposed controls wording included in Update Report;

details of the product stewardship (renamed Responsible Handling Information) control;

details of proposed phase-in and phase-out timings for controls and for disposal of substances

not re-approved.

1 https://www.epa.govt.nz/public-consultations/in-progress/reassessment-of-paraquat/

https://www.epa.govt.nz/public-consultations/in-progress/reassessment-of-paraquat/



1.5 The updated proposals are contained in Tables 1 and 2 (with changes highlighted).

Table 1: Proposed fate and hazard classification of paraquat approvals.

Substance HSNO

approval no. EPA proposal

Proposed HSNO

classification

Paraquat

Known trade name: none

HSR003041 Retain approval with prescribed

and additional controls 1 and 2

6.1A (overall):

[6.1A (inhalation), 6.1E

(dermal), 6.1C (oral)]

6.3B, 6.4A, 6.9A (oral)

9.1A, 9.3B, 9.4B

[No changes to prescribed

controls result from these

changes – refer to EPA

website]

Soluble concentrate

containing 115 g/litre

diquat as the dibromide

salt and 135 g/litre

paraquat as the dichloride

salt

Known trade name:

Preeglone

Kuatout

Speedy Herbicide

HSR000447 Retain approvals for purposes of

agricultural uses only with

prescribed and additional

controls 3 to 10

(note: additional control 6 is no

longer proposed)

6.1A (overall):

[6.1A (inhalation), 6.1B

(dermal), 6.1B (oral)]

6.3A, 6.4A, 6.5B, 6.9A (oral)

9.1A, 9.3A, 9.4B


controls result from these

changes – refer to EPA

website]

Soluble concentrate

containing 200 - 250 g/litre

paraquat as the dichloride

salt

Known trade names:

AGPRO Paraquat 200

Paraquat 200SL

PQ 200

Gramoxone 250

Flash Herbicide

Parable

HSR000828 6.1A (overall):

[6.1A (inhalation), 6.1E

(dermal), 6.1C (oral)]

6.3A, 6.4A, 6.9A (oral)

9.1A, 9.3B, 9.4B


controls result from this

change – refer to EPA

website]

Gramoxone Inteon

Known trade name:

Gramoxone Inteon

HSR007847 Revoke approvals

- Prohibition on further

importation or manufacture

- Disposal of any existing stocks

within 12 months of decision

N/A

Preeglone Inteon

Known trade name:

Preeglone Inteon

HSR007854

Uniquat 250

Known trade name:

Uniquat 250

HSR100443


https://www.epa.govt.nz/database-search/approved-hazardous-substances-with-controls/view/2761








Substance HSNO

approval no. EPA proposal

Proposed HSNO

classification

Parable 250

Known trade name:

Parable 250

HSR100572

Table 2: Proposed additional controls to be applied to paraquat approvals which are proposed to be retained.1

Additional

control number

Control description

1 Specification of pesticide and veterinary medicine actives

Importers and manufacturers must provide specified information to the EPA, relating to

manufacturing and impurity details of paraquat.

Refer to EPA website for complete details.

Note: these requirements are specified in the current controls for paraquat

2 Prohibition on use of substances

Paraquat can only be used for the following purposes:

for research and development (excluding release, discharge or application into the

outdoor environment)

as an ingredient or component in the manufacture of another substance or product

Refer to EPA website for complete details.

Note: these requirements are specified in the current controls for paraquat

3 Impurity specification control:

The technical grade active ingredient used in this substance shall 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





Additional

control number

Control description

4 Requirements for emetics and stenching agents:

The paraquat-containing substance must contain 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, 20082; and

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

Note: these requirements are specified in the current controls for most of the approvals for

paraquat-containing herbicides.

5 Use and application parameter restrictions [+ label]:

maximum single application rate = 600 g (paraquat ion) / ha

maximum annual application rate = 600 g (paraquat ion) / ha

for agricultural or biosecurity use only, where biosecurity use requires a s95A

permission

prohibit application onto / into water

For avoidance of doubt, agricultural use includes ornamental horticulture but excludes

forestry plantation uses.

Note: prohibiting application onto or into water is a requirement of the EPA (Hazardous

Property Controls) Notice 2017

This control is to be reflected on the label.

6 Application equipment restrictions [+ label]:

Prohibit hand-held application methods (ie handgun, knapsack application)


7 Spray droplet specification [+ label]:

Application using coarse spray droplets only for ground based application and coarse to very

coarse droplets for aerial application.

Droplet size descriptors as defined by the American Society of Agricultural and Biological

Engineers ASABE Standard (S572) or the British Crop Production Council guidelines.

Note: for both ground-based and aerial application, droplets larger those specified may be

used


2 http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Specs/Paraquat08.pdf ; accessed

from http://www.fao.org/agriculture/crops/thematic-sitemap/theme/pests/jmps/ps-new/en/ on 7 January 2019.


http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Specs/Paraquat08.pdf

http://www.fao.org/agriculture/crops/thematic-sitemap/theme/pests/jmps/ps-new/en/



Additional

control number

Control description

8 Downwind Buffer Zones [+ label]:

The buffer zones for ground-based and aerial applications are detailed below:

Application

method

Sensitive receptor 400 g ai/ha 600 g ai/ha

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 5 m 15 m

Non-target plants

(non-threatened)

40 m 40 m

Non-target plants

(threatened)

60 m 100 m


Explanatory note: no BZs are set for application using non-motorised handheld equipment.

9 Responsible Handling Information Product Stewardship:

Product owners (ie importers or manufacturers) to produce, maintain and make

available Responsible Handling Information that details how to safely handle the

substance through its lifecycle, from storage to disposal, and provides information that

is consistent with the controls imposed on the substance.

Prior to use, users must-

o produce a written declaration that they have read and understood the

product stewardship information;

o retain the written declaration as part of their application records.

Information to be provided with products to users in order to highlight that controls have

changed, where to find further information, highlighting where changes affecting use

have been made.

10 Further additional label statements:

Additional controls tagged with [+ label] are to be reflected on the product label

Do not apply when wind speeds are less than 3 km/h or more than 20 km/h as

measured at the application site.

To reduce runoff from treated areas into aquatic habitats avoid application to areas with

a moderate to steep slope, compacted soil, or clay.

Avoid application when heavy rain is forecast.

Do not transfer this product into food or drinks containers, or into unlabelled containers.

Note: Buffer zones and application parameter restrictions required to be included on product

labels [EPA (Labelling) Notice 2017].



1 Paraquat approvals are also subject to the controls prescribed in the EPA Notices, and Health and Safety

at Work (Hazardous Substances) Regulations 2017, as listed in Appendix A.

2 This document and background

2.1 The EPA has reviewed use of paraquat herbicides in New Zealand and in its application3 made

a number of proposals in regard to how the risks associated with on-going use can be

managed.

2.2 The application contained the following proposals:

revoke approvals with mutagenic (HSNO class 6.6), carcinogenic (HSNO class 6.7) or

reproductive toxicant (HSNO class 6.8) classifications;

revoke unused approvals which are not used by products registered under the Agricultural

Chemicals and Veterinary Medicines Act;

retain two approvals, subject to greater restrictions compared to existing controls.

2.3 The application also contained details of risk mitigation measures being considered by

WorkSafe New Zealand for on-going use of paraquat herbicides.

2.4 The application identified a number of data gaps that, if additional information could be

provided, may impact on the assessment and proposals presented:

reliance on paraquat in kūmara production;

further information on alternatives and their effectiveness;

provision of refined risk assessment;

relevance of identified risks to birds;

risks to birds associated with multiple applications of paraquat within a growing season.

2.5 This document is intended to provide an update to the assessment and proposals contained in

reassessment application of paraquat-containing herbicides after taking information provided

through submissions into account.

2.6 It should be noted that the analysis and proposals contained in this Update Report are those of

the EPA staff. In its decision-making capacity, the decision-making committee may choose to

accept, reject or modify the recommendations presented herein.

Key application dates

Receipt of application

2.7 This reassessment application was received on 25 February 2019.

Submission period

2.8 The submission period began on 28 February 2019.

3 See EPA website: https://www.epa.govt.nz/database-search/hsno-application-register/view/APP203301 .


https://www.epa.govt.nz/database-search/hsno-application-register/view/APP203301



2.9 The submission period was due to close on 11 April 2019, in line with the statutory time frame of

30 working days.4

2.10 In response to three requests, the submission period was extended by waiving the statutory

timeframe, until 30 April 20195 on the basis that no person would be unduly prejudiced by an

extension to the submission period.

3 Analysis of submissions

3.1 This section summarises the administrative details of the submissions received on this

application.

Submissions received Table 3 provides details of the parties that made submissions on this reassessment.

4 HSNO Act s 59 (1)(c) .

5 HSNO Act s 59 (3)-(5) .



Table 3 Submitters on this reassessment

Group/organisation Wish to be heard?

Adama New Zealand Limited No

Agpro NZ Limited No

Dairy NZ Yes

Department of Conservation - Auckland Conservancy No

Farmlands Co-operative No

Farmlands Grain & Seed No

Federated Farmers of New Zealand Yes

Horticulture New Zealand Yes

Market Access Solutionz Ltd Yes

New Zealand Beekeeping Incorporated No

Pearler Bay Farm No

Potatoes New Zealand Yes

Syngenta Crop Protection Limited Yes

Te Wahapu o Hokianga Nui a Kupe No

(individual) No

(individual) No

(individual) No

(individual) Yes

3.2 Submitter support and opposition of the initial proposals relating the fate of paraquat-related

approvals can be grouped generally as below:

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, 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 of 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 in-

line 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).

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

o maximum application rate and frequency;

o additional record-keeping requirement;

o controls that WorkSafe NZ were considering to implement, including: health

monitoring requirements, additional licensing requirements, closed mixing/loading

requirements, prohibition of hand-held use, restriction of use to closed cab

application, and additional record-keeping requirements.

3.3 We have used the information gained from submissions, where relevant, to refine our position

on the risks and benefits associated with paraquat use. Key issues raised in submissions are

highlighted in Sections 4 – 8. The views of submitters are presented hereafter, with the EPA

responses clearly identified.

4 Issues identified in submissions

4.1 This section distils the key and significant issues raised by submitters, and provides responses

to those issues. Discussion relating to specific issues are provided in specific sections:

human health and environmental effects, Section 5,

economic assessment in Section 6,

WorkSafe-related issues in Section 7,

proposed controls presented in the application in Section 8.

Uses of paraquat

4.2 The submissions provided some information relating the use scenarios of paraquat. Most of the

scenarios described aligned with the understanding described in the application form and

included uses on lucerne, plantain, clover, in pasture renovation, and as a desiccant. Submitters

emphasised that paraquat is used as a desiccant in plantain seed and clover seed crops.

4.3 Market Access Solutionz submitted that paraquat is not used as a pre-harvest desiccant in

kūmara production, as suggested in the application. Market Access Solutionz emphasised that

paraquat is used on kūmara crops at low rates before the crop establishes to manage weeds,

and for inter-row weed control post-emergence. Use on kūmara is discussed in

paragraphs 4.5 – 4.11.

EPA staff response

4.4 Some clarification was sought by the EPA in regard to the use of paraquat in clover crops. Both

Syngenta and Federated Farmers were queried on this use pattern, as Syngenta is a significant

manufacturer and developer, and Federated Farmers represent a large portion of growers who

practise this use pattern commercially. Clarification regarding grazing and commercial clover

seed production, the timing of closing, and paraquat use in relation to closing was provided.



Kūmara reliance on paraquat

4.5 The reliance of kūmara production on paraquat use was highlighted as a concern in the

application.

4.6 In compiling the application form, it was unclear why there was disparity in the reliance on

paraquat between kūmara and potatoes, as it was considered that these crops are similar. The

impact of paraquat on the yield of the two crops was reported to be vastly different, and there

are many alternative herbicides used for potato crop protection. It was suspected that since

kūmara is a minor crop, there are few herbicides with label claims for kūmara crop protection,

and thus paraquat as an effective broad-spectrum herbicide may be the first choice for use in

kūmara crops. Submitters were encouraged to provide further information relating to alternative

kūmara crop protection products, and the influence of paraquat use on kūmara yields.

4.7 Market Access Solutionz submitted some commentary on the use of paraquat in kūmara crops,

and the reliance of the kūmara sector on paraquat.

a. Kūmara and potatoes are not the same species of plants and their growth habits and

production regime are vastly different and cannot be compared. Paraquat is not used as a

pre-harvest desiccant in kūmara crops, the two main uses being: several applications of 100

g ai/ha while kūmara are developing roots, and inter-row weed control at 400 g ai/ha once the

canopy begins to develop.

b. Kūmara is particularly vulnerable to competition from weeds, and would either need to be

hand-weeded, or treated with alternative herbicides.

c. In order to adequately manage weeds, alternative herbicides need to be used at application

rates which cause significant damage to kūmara crops and accordingly substantially

decrease crop yields. If systemic herbicides were used, the entire kūmara plant will die.

Several sprays of paraquat are required to control weeds when they are at cotyledon stage

(once weeds reach the four-leaf stage, thick layers of wax on leaves make paraquat less

effective).

4.8 Market Access Solutionz have also commented on cultural aspects associated with kūmara in

regard to paraquat use, indicating that given the cultural value of kūmara to Māori, there is

significant cultural benefit in allowing multiple applications of paraquat to control weeds in

kūmara crops, so as to ensure ongoing availability of this esteemed vegetable.

EPA staff response

4.9 The points raised regarding paraquat use on kūmara, including the current use pattern where

paraquat-containing substances are applied repeatedly within a growing season, and difference

between kūmara and potatoes are acknowledged. It is also acknowledged that paraquat is not

used as a pre-harvest desiccant in kūmara crops.

4.10 In regard to the cultural value of kūmara, we reiterate that kūmara is an iconic Māori vegetable

that was brought to New Zealand by the ancestors of Māori, and a substantial body of lore

exists around this plant. However, Māori are generally opposed to the use of agrichemicals on

food plants, more so in respect of kūmara due to its special cultural status. It is difficult to

reconcile use of paraquat on kūmara (a taonga vegetable) from a tikanga perspective, ie it is not

consistent with Māori environmental frameworks, including the practice of kaitiakitanga

(environmental guardianship), and the relationship Māori have with Papatūānuku (land and

soils). We are not convinced that kūmara production would cease, or no longer be part of the




New Zealand diet, particularly for Māori, if paraquat was to be banned. Māra kai (Māori food

gardens) and some home gardens would certainly grow kūmara, and it is likely that some

commercial kūmara growers would successfully manage weeds without using paraquat

products.

4.11 That being said we consider that up to six applications of 100 g ai/ha would be acceptable,

which correlates to a total of 600 g ai/ha per year being an acceptable application to a field.

Accordingly the use patterns described by kūmara growers would be retained in the revised

proposals, albeit with some restriction. With the development of paraquat-resistant black

nightshade in regions where kūmara are grown,6 any encouragement of alternative herbicide

use in kūmara production is considered beneficial. It is noted that some research into alternative

herbicides for use in kūmara production has been undertaken,7 and further development

(relating especially to less hazardous herbicides) is encouraged.

Alternatives and resistance management

4.12 An analysis of alternative herbicides to particular paraquat uses was presented in the

application for reassessment.8 The analysis did not make any direct comparisons between

paraquat and other herbicide active ingredients in terms of the reasons why users choose to

select paraquat over other options. Submitters were encouraged to provide information that

details the reasons why paraquat was used in preference to other options.

4.13 Submitters suggested that paraquat was the alternative to many other herbicides, and reiterated

the importance of its use in resistance management, especially when treating glyphosate-

resistant weeds. Paraquat is one of only two herbicide active ingredients approved in New

Zealand which are in herbicide group D9. Submitters indicated that paraquat offers advantages

over some of these alternatives, as it presents a lower risk of crop damage compared to other

alternatives, such as glyphosate, and is considered by some as being more efficacious. A

number of submitters have asserted that paraquat use in resistance management was

undervalued in the analysis presented in the application form. Market Access Solutionz also

indicated that a growers’ decision to use paraquat was primarily driven by efficacy, not cost.

4.14 Federated Farmers submitted that a non-chemical alternative to paraquat use as a desiccant in

seed production was windrowing (cutting and drying naturally). Federated Farmers described

the risks in the windrowing process, which included loss of yield through seed shattering and

unanticipated weather conditions, and also missing optimum harvest windows. Accordingly,

Federated Farmers did not consider windrowing as a viable alternative to paraquat for seed

crop desiccation.

6 https://www.freshvegetables.co.nz/assets/Members-pdfs/F001435823-2005-Paraquat-resistance-in-black-

nightshade-Copy.pdf

7 https://www.freshvegetables.co.nz/assets/PDFs/Kumara-SARP-NZ-final-report-SFF-07-040-2008-1.08.pdf

8 Table 5 and supporting text in the application form: https://www.epa.govt.nz/assets/FileAPI/hsno-

ar/APP203301/6e3f8f5037/APP203301-Final-Application-Form.pdf

9 A group D herbicide is the Herbicide Resistance Action Committee (HRAC) categorisation of mode of action of

the active ingredient. Group D corresponds to photosystem I electron diversion. There are two herbicides in

this class: paraquat and diquat, and they work by accepting an electron from photosystem I, forming a

herbicide radical, which is extremely reactive with the ability to lead to destruction of cell membranes and

chlorophyll. HRAC group D is equivalent to group 22 of the Weed Science Society of America (WSSA)

categorisation.

https://www.freshvegetables.co.nz/assets/Members-pdfs/F001435823-2005-Paraquat-resistance-in-black-nightshade-Copy.pdf

https://www.freshvegetables.co.nz/assets/Members-pdfs/F001435823-2005-Paraquat-resistance-in-black-nightshade-Copy.pdf

https://www.freshvegetables.co.nz/assets/PDFs/Kumara-SARP-NZ-final-report-SFF-07-040-2008-1.08.pdf

https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/6e3f8f5037/APP203301-Final-Application-Form.pdf

https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/6e3f8f5037/APP203301-Final-Application-Form.pdf



EPA staff response

4.15 We note that paraquat and diquat are the only herbicides approved in New Zealand which are

group D herbicides. It is recognised that paraquat is a key herbicide in resistance management

because of its group D mode of action, and because it is a contact herbicide that does not

translocate (and accordingly has a reduced likelihood of resistance developing). As it is

proposed that the use of paraquat will not be completely prohibited, it is considered that the

benefit offered by paraquat to resistance management in weeds is retained. It is further noted

that there have been some reports of paraquat-resistant weeds, and accordingly any

encouragement of alternative herbicides is considered to be of benefit to overall resistance

management of pest plants.

4.16 We note the point raised that efficacy is a key factor in decisions made on paraquat use. The

cost effectiveness of paraquat has been highlighted as a benefit by a handful of stakeholders in

both the call for information and submission phases of this review. We maintain this may be a

benefit realised by end users, but do not suggest that price of the herbicide is the sole factor

behind the choices end-users make. There is some further discussion in the economic update

report regarding this issue in Appendix B.

4.17 We acknowledge that there does not appear to be a like-for-like replacement for paraquat

herbicides, and that paraquat herbicides have a number of beneficial attributes (such as quick-

acting, rain-fast and broad ranging herbicidal activity) that contribute to a decision to employ

paraquat as a weed control tool. Our proposal allows key paraquat usage to be retained, so that

the key benefits are also retained.

5 Issues relating to human health and environmental effects

5.1 The original human health and environmental risk assessments were contained in Appendix D

of the application form10. Updates to the human health and environmental risk assessments are

included in their entirety in Appendix C and Appendix D of this document respectively.

5.2 The approach to the assessment of risks associated with use of paraquat herbicides

represented the assessment of generalised or approximated use scenarios. Submitters were

encouraged to provide their refined risk assessments or supported arguments to justify a

different position on the risks.

5.3 Syngenta submitted higher tier human-health and environmental risk assessments.

5.4 In response to information received in submissions, we have amended and refined our risk

assessment.

5.5 The outcomes of the initial assessment as presented in the application form indicated that

application rates above 400 g ai/ha presented risks to birds that were outstanding and

unacceptable given the level of benefit offered. In their submission Syngenta provided

assessment and analysis of risks to birds relating to application rates up to 600 g ai/ha. No

additional information relating to risks to birds at application rates higher than 600 g ai/ha was

10 https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/e4fa8fa35a/app203301-Appendix-D-Science-

Memo.pdf


https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/e4fa8fa35a/app203301-Appendix-D-Science-Memo.pdf




received. Accordingly, human health and environmental risk assessments were refined in view

of a maximum application rate of 600 g ai/ha.

Human health

5.6 Three submitters indicated that they would like to see all approvals for paraquat-containing

substances banned.

5.7 Pearler Bay Farm submitted an excerpt from the paraquat Wikipedia page relating to toxicity

and Parkinson’s disease. The submitter suggested that paraquat be completely banned citing

its long established lethality.

5.8 A submission from Ms. Lynne Clapham has raised concern that the science report did not

adequately clarify that even though paraquat is classified as a 6.1A toxicant due to its acute

inhalation toxicity the risk management of it needs to revolve more around its 6.9 classification

which is lung toxicity via the other exposure routes (oral and dermal) and as such could impact

how that risk needs to be managed.

5.9 Syngenta submitted a higher tier human health risk assessment. Syngenta advocates that

knapsack application methods should not be eliminated as they do not pose an unmanageable

risk and that respiratory protection is not needed. Syngenta noted that the modelling

methodology the EPA utilised was likely overly conservative and as such they provided a

“higher tier” assessment for both boom and knapsack application methods. Syngenta noted

they have been working with an engineering design company to develop a fully closed loop

delivery system that can be retrofitted to all knapsack sprayers. This system is designed to

eliminate exposure to the concentrate product.

EPA staff response

5.10 The concerns raised by Pearler Bay Farm are noted. The science assessment presented in the

application form acknowledges the toxicity of paraquat, and suggests hazard classifications to

reflect this. The human health risk assessment suggests the risks of paraquat use can be

managed if appropriate controls (restrictions) on the substance are in place. In a review of

paraquat produced by the APVMA, the toxicological and neurotoxicological effects were

investigated. The APVMA found no causal relationship between paraquat and Parkinson’s

disease. This is the position adopted in this assessment.

5.11 The EPA agrees with the submission from Lynne Clapham that the exposure routes which

correlate to the 6.1A and 6.9 classifications is an important distinction and concept that requires

addressing. While not evident from the science memo the submitter should know that WorkSafe

regulators are intimately involved with the EPA’s reassessment team and through personal

communication during meetings it has been pointed out and explained to them that even though

the 6.1A hazard is based on an inhalation study, the risk of the lung toxicity (6.9A hazard) is a

result of an over exposure to paraquat from the oral and dermal exposure routes.

5.12 A subsequent refinement of the original risk assessment was drafted and made available to

WorkSafe which goes into much more depth around this distinction. The new risk assessment

makes it more evident that despite the fact that acute inhalation data are driving the 6.1A

classification, this exposure route is not a relevant route of exposure likely to lead to toxicity.

This is because paraquat is of very low volatility and the size of the spray droplets formed for its



application on crops are too large (non-respirable) to reach the lung alveoli to enter the blood.

Thus, inhalation is not a meaningful exposure route.

5.13 Concerns were also raised by Ms Clapham that further clarification of this distinction could be

made through a more in depth discussion in the toxicokinetics section. The EPA does not

believe a more detailed discussion is warranted to describe the mode of action of paraquat and

how an oral (or dermal) exposure can result in lung damage as such information will not impact

the risk assessment and how risks are managed.

5.14 Accordingly, the EPA believes that WorkSafe risk managers have been made aware of the

submitter’s concerns and that these concerns have been addressed through both personal

communication and by a more in depth risk assessment which has been reviewed by WorkSafe.

5.15 We agree with issues raised in Syngenta’s submission as follows:

Initial modelling was overly conservative arising from conservative default values in the

exposure models;

Inhalation is not a significant contributor to paraquat exposure;

5.16 We remain of the opinion that it is appropriate to wear adequate PPE during mixing, filling, and

application of paraquat to prevent dermal exposure and minimize risk. However, respiratory

protection is not deemed necessary as that is not a pertinent exposure route.

Environment

Birds

5.17 Uncertainties and outstanding concerns relating to birds were highlighted in the application.

5.18 The Canadian PMRA concluded that the risks to birds identified in their assessment were not

significant for a number of reasons, including conservatism of feeding assumptions in

assessment, strong adsorption of paraquat to soil, and the particular timing and circumstances

of applications of paraquat11. At the time the Application was made available for public

submission, information to support a similar conclusion in New Zealand use scenarios has not

been provided, and the risks to birds are considered above the level of concern. It was posited

that multiple applications could present greater risks and consequently, mitigation measures

that limit the number of applications to those assessed should ensure that risks do not exceed

those identified in that assessment.

5.19 Submitters were invited to comment on the relevance of these assessment findings, particularly

in regard to paraquat use in New Zealand agricultural settings and how that relates to bird

feeding habits. Submitters were encouraged to provide data relating to paraquat bioavailability

once adsorbed to soil or vegetation, and how that might impact on birds feeding in treated

areas. Furthermore, submitters were also invited to comment on the use of the No Observable

Effects Level of 1.7 mg ai/kg bw/day for use in the bird exposure modelling (see section 5 in

11 https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-

pest-management/decisions-updates/reevaluation-note/2015/rev2015-14-special-review-decision-

paraquat.html


https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/decisions-updates/reevaluation-note/2015/rev2015-14-special-review-decision-paraquat.html





Appendix D of the application form for details12). Submitters were invited to provide

assessments on risks to birds associated with multiple applications of paraquat within a growing

season.

5.20 Market Access Solutionz provided a critique on the bird risk assessment performed by the EPA,

and suggested that use of a study investigating the effects on turkeys was more relevant to New

Zealand birds than what was used in the EPA’s initial assessment.

5.21 Syngenta provided a higher tier bird risk assessment as part of their submission, which was

used to inform EPA’s revised risk assessment. Syngenta’s submission also provided the EPA

with a rationale for changing the toxicity endpoint values in the risk assessment.

5.22 Federated Farmers submitted that there were some techniques and practises which are

currently available which can be used to deter bird presence and accordingly mitigate exposure

risk. These mitigation measures include: sound scarers (gas guns and broadcast noise), visual

scarers (kites and pyrotechnics), toxins and other repellents, drape netting, technologies

including drones and lasers. In addition, the submission states that spraying was undertaken

during the evening when birds and pollinators were not present, and suggests that if spraying

was conducted during daylight hours, acute risks to birds would be minimised due to the noise

of the sprayer, and that birds were unlikely to fly under the spray boom.

5.23 The Department of Conservation submitted that there have been observations of wildlife in

cropping and agricultural areas using these areas for habitation and feeding. It was noted that

these observations were casual, and that there is a general shortage of publications relating to

wildlife behaviour in agricultural and pine forest ecosystems, especially in respect to post-spray

operations. Considering the variation of wildlife in horticultural and forestry areas, the

Department of Conservation suggested that a site-specific environmental risk assessment and

mitigation plan should be required for paraquat use.

EPA staff response

5.24 Our risk assessment approach, whilst intended to be as standardised as possible, is tailored as

necessary to achieve the most comprehensive overview of risks presented through the lifecycle

of a given reassessment candidate, and is informed by best international practices. We have

provided the methodology used for this assessment so are satisfied that the information

provided is in an understandable and digestible form.

5.25 The EPA only consider values from studies which are scientifically robust for risk assessment.

The study on turkeys was carried out in the 1970’s using an approach which is not consistent

with current testing approach recommended by the Organisation for Economic Co-operation

and Development (OECD 223). Furthermore there appears to be significant inconsistencies in

this study regarding how the reported LD50 was calculated. For these reasons the study was

not used for risk assessment. A more detailed summary of this study can be found in the

environmental risk assessment section. In response to the revised risk assessment that

Syngenta provided, and in response to requests to allow application rates up to 600 g ai/ha, we

undertook a review of the material presented and used it to refine our environmental risk

12 https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203301/e4fa8fa35a/app203301-Appendix-D-Science-

Memo.pdf





assessment where it was considered appropriate to do so. A detailed report of this review and

our refined risk assessment is provided in Appendix D.

5.26 The refined risk assessment, informed by information provided in Syngenta’s submission,

concluded that in use patterns including clover seed desiccation, pre-emergent use, and use on

lucerne (rates of 400 g ai/ha and 600 g ai/ha), acute risks to both non-threatened and

threatened bird species were found to be lower than the level of concern. For these use

patterns, chronic risks to both threatened and non-threatened bird species were above the level

of concern. It should be noted that the identified risks are lower than the corresponding risks for

the more stringent restriction presented in the application (ie 400 g ai/ha).

5.27 The remainder of the environmental risk assessment remains unchanged, which indicated that

the risks to other receptors can be managed with appropriate controls. This contributes to the

risk/benefit assessment conclusion presented in the application and is discussed further in

Section 9.

5.28 While we would support measures employed to provide additional protection to birds, we have

no information on the on-going effectiveness that such measures would offer, or whether they

would be appropriate for use in all circumstances of use of paraquat. Consequently, we are not

proposing their use as control measures. In terms of chronic (long-term, repeat exposures) we

consider that these risks will be best addressed through restrictions on the use of paraquat.

5.29 In terms of the suggestion that a site-specific environmental risk assessment and mitigation plan

should be required for paraquat use, we would consider that such requirements would be

incorporated in Best Practice, and as such forms part of responsible use paraquat. Furthermore,

there are requirements in regional plans, either citing specific spray plan requirements or by

reference to the New Zealand Standard on Management of Agrichemicals, NZS8409:2004.

These requirements require a property owner to produce a property spray plan identifying

hazards for planned agrichemical use and details how they will be managed to avoid or

minimise any adverse effects on people and the environment from the agrichemicals used.

Consequently, we do not propose to introduce a specific control as we anticipate that this is

already addressed through requirements of the regional plans.

Persistence

5.30 Concerns were presented in the application regarding the persistence of paraquat in the

environment and the potential effects that could arise associated with on-going, long-term use

as a herbicide.

5.31 The persistence of paraquat in soil and aquatic environments was also flagged as a cultural

concern, as paraquat application could result in spiritual contamination of Papatūānuku (Land

and soils) and Te Marae o Maru (Freshwater environments).

5.32 Some submitters suggested that paraquat was easily broken down and only available to soil

organisms at low concentrations. Others suggested that it took a while to be broken down, but

was not an issue because it was not biologically available, and effectively inert.

5.33 Syngenta indicated that, while paraquat has a low rate of dissipation in soil (with degradation

time DT50 values of around five to 20 years), paraquat remains tightly bound to soil particles and

data show that is not bioavailable. However, study data confirm that paraquat is intrinsically




biodegradable, demonstrated by its complete degradation and rapid mineralisation, to CO2 upon

release from the soil particles.

EPA staff response

5.34 We note the comments in regard to the persistence of paraquat, acknowledging that free

paraquat can be readily degraded. However, we consider that paraquat is most likely to bind to

soil and remain in the soil for a significant number of years, albeit deactivated.

5.35 In regard to cultural risks, rituals may be able to be administered to address some concerns

around spiritual contamination of Papatūānuku and Te Marae o Maru.

6 Updates to benefits assessment

6.1 In response to information received in submissions, we have considered the impact on our

previous proposals and refined our benefits assessment.

6.2 Sapere have documented 12 key issues raised in relation to the economic assessment, and

provided responses (refer to Appendix B), and also identified where there have been any

changes to their findings.

6.3 In summary, the revised results are as follows:

a. Following review of, and response to submissions we have increased our estimates of the

economic value of paraquat (expressed in terms of potential loss of GDP) by between

$9 million and $15 million annually.

b. Paraquat use contributes between $39 million and $75 million to annual GDP (the previous

estimate was between $30 million and $60 million annually).

c. A ban on paraquat use would result in a minimum of $39 million and a maximum of

$75 million of annual GDP loss per year (less than one half of one per cent of annual GDP

nationally)

d. Figure 1 shows that restricting the application rate of paraquat to:

i. 300 grams of active ingredient per hectare (g ai/ha) would put up to

$72 million in GDP at risk annually;

ii. 400 g ai/ha would put up to $25 million in GDP at risk annually;

iii. 600 g ai/ha would put up to $0.14 million in GDP at risk annually.



Figure 1: GDP value at risk from restricted application rates for paraquat (reproduced from Appendix B)

7 WorkSafe’s responses to submissions related to the WorkSafe report

7.1 WorkSafe provided a report relating to the work place health and safety aspects of the paraquat

reassessment, which was presented in Appendix G of the application form13.

7.2 The responses in this section were prepared by WorkSafe in their capacity as part of the project

team. Any proposed controls discussed here which relate to the management of risks in a

workplace will not be implemented as part of a decision on this reassessment, which is decided

by a decision-making committee empowered by the HSNO Act. Any proposed risk mitigation

measures will need to undergo a separate process to be incorporated in a Safe Work

Instrument (SWI) under the Health and Safety at Work Act before being implemented.

Submission theme 1:

7.3 Generally the submissions did not support a controlled substances licence (CSL) requirement

for paraquat-containing substances.

WorkSafe response:

7.4 WorkSafe has decided that a requirement to hold a CSL for paraquat is not required. However,

we intend to clarify the requirements for obtaining a certified handler certificate for class 6.1A

13 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



substances. We are proposing that certificates will list the specific class 6.1A substances

covered by the certificate. Certified handlers with a certificate for paraquat would have to

demonstrate a knowledge of the specific hazard classification, properties, adverse effects and

safe use of paraquat.

Submission theme 2:

7.5 While Federated Farmers supports the use of applicators with appropriate filtration systems,

which may include closed cab applications, other submitters did not support this proposal. In

their submission, Federated Farmers indicated that none of their members were applying

paraquat-containing substances using open cab tractor or open cab spray apparatus.

7.6 The reasons given by submitters for not supporting closed cab application were that the EPA

modelling showed that the use of appropriate personal protective equipment (PPE) would

effectively manage the risk, and that the cost may be too high for some persons conducting a

business or undertaking (PCBUs).

WorkSafe response:

7.7 WorkSafe is interested in further information regarding why this requirement may not be

practicable for duty holders. This could include more detail on why the cost compared to the risk

is disproportionate.

Submission theme 3:

7.8 Generally submitters did not support the proposal to require a closed packaging and transfer

system.

7.9 The reasons given by submitters for not supporting a closed packaging and transfer system

requirement were that the EPA modelling showed that the use of appropriate PPE would

effectively manage the risk, and that the cost may be too high for some PCBUs. Federated

Farmers estimated it would cost $5,000 to set up a closed packaging and transfer system.

WorkSafe response:

7.10 WorkSafe is interested in further information regarding why requiring a closed packaging and

transfer system may not be practicable for duty holders. This could include more detail on why

the cost compared to the risk is disproportionate.

Submission theme 4:

7.11 No further information regarding re-entry worker activities was provided by submitters.

WorkSafe response:

7.12 WorkSafe still has some concerns for re-entry worker exposure and seeks information on re-

entry activities.

Submission theme 5:

7.13 Submitters were not supportive of WorkSafe setting Information Requirements for Records of

Use which required documenting the risk assessment process to determine if paraquat was the

safest option available for the intended use.



7.14 A number of industry groups consider that there is no alternative to using paraquat.

Worksafe response:

7.15 We note that PCBUs should regularly review their risk management controls, this includes

considering whether a hazardous substance can be substituted for a less hazardous one.

However, we consider that requiring duty holders to keep a record of the risk assessments

would provide no additional benefit. WorkSafe propose not to set additional requirements for

records of use.

Submission theme 6:

7.16 Submitters were not supportive of health monitoring.

WorkSafe response:

7.17 Due to the infrequent use of paraquat, WorkSafe propose not to set a health monitoring

requirement. However, where workers frequently work with paraquat, WorkSafe expects PCBUs

to undertake appropriate health monitoring as part of their risk management activities.

WorkSafe response on hand held application of paraquat.

7.18 In the application document the EPA proposed prohibiting handheld application methods. The

EPA have reconsidered this proposal and is no longer proposing to include this restriction.

7.19 Submitters have indicated that in some situations there may be no other herbicides available for

spot treatment of weeds.

7.20 In their submission Syngenta provided an operator exposure assessment which has modelled

the use of a closed transfer system for handheld spraying. The results of this modelling show

how the risk quotient can be reduced with the use of the closed transfer system.

7.21 WorkSafe is considering a closed mixing and transfer system control for all methods of paraquat

application, this includes handheld application.

8 Updates to proposed risk mitigation measures

8.1 In response to information received in submissions and our revised assessment, we have

amended our proposed risk mitigation measures.

Revocation of approvals with CMR classifications (HSR100443 and HSR100572)

8.2 It was proposed that approvals with mutagenic (HSNO class 6.6), carcinogenic (HSNO class

6.7) or reproductive toxicant (HSNO class 6.8) classifications be revoked, on the basis that

those substances do not offer additional benefit, despite having a higher hazard/risk profile.

8.3 Approval HSR100443 is classified as 6.7B and 6.8B. Approval HSR100572 is classified as

6.7B.

8.4 New information was obtained that suggested approval HSR100443 (separate to the paraquat

reassessment) should not be classified as 6.8B. As HSR100443 is still classified as 6.7B, it is

still proposed to revoke this approval.




8.5 Considering that no submissions were received which disagreed with this proposal, and both

HSR100443 and HSR100572 are still considered to be classified as 6.7B, the proposal to

revoke these approvals is unchanged.

Revocation of approvals with no evidence of use (HSR007847 and HSR007854)

8.6 It was proposed that approvals which are not used by products registered under the Agricultural

and Veterinary Medicines Act be revoked, on the basis that those approvals are not in use and

offer no benefit to New Zealand.

8.7 Horticulture New Zealand opposed the revocation of unused approvals, suggesting that they

could be used in future if manufacturers reformulate their paraquat-containing substance, and

since these approvals are not being used, they present no risk. Horticulture New Zealand

opposed setting a precedent for revocation of unused approvals for agrichemicals of limited

use, suggesting approved agrichemicals with limited use may in future be used for biosecurity

purposes.

EPA staff response

8.8 The approvals HSR007854 and HSR007847 contain the active ingredients at concentrations

which are the same as, or are within the range of active ingredient covered by HSR000447 and

HSR000828 respectively.

8.9 These are essentially duplicate approvals and are not significantly different from the approvals

proposed to be retained in terms of what is offered by those approvals. There are no differences

between HSR007854 and HSR007847, and HSR000447 and HSR000828, in the context of

biosecurity. Accordingly this proposal is unchanged.

8.10 We remain of the opinion that retaining approvals presents a level of risk, given the inherent

hazardous nature of the substances in question, with no actual benefit being realised given that

there are no products available using those approvals.

Retained approvals

8.11 It was proposed to retain three approvals as it was considered that they provide a level of

benefit, which outweighs the residual risk posed by the substances with additional risk

mitigation measures in place.

8.12 In the application, it was proposed that the hazard classification of these substances would be

as follows:

a. Paraquat (HSR003041):

6.1A (overall): [6.1A (inhalation), 6.1E (dermal), 6.1C (oral)], 6.3B, 6.4A, 6.9A (oral), 9.1A,

9.3B, 9.4B

b. Soluble concentrate containing 115 g/litre diquat as the dibromide salt and 135 g/litre

paraquat as the dichloride salt (HSR000447):

6.1A (overall): [6.1A (inhalation), 6.1B (dermal), 6.1B (oral)], 6.3A, 6.4A, 6.5B, 6.9A (oral),

9.1A, 9.3A, 9.4B

c. Soluble concentrate containing 200 - 250 g/litre paraquat as the dichloride salt (HSR000828):



6.1A (overall): [6.1A (inhalation), 6.1E (dermal), 6.1C (oral)], 6.3A, 6.4A, 6.9A (oral), 9.1A,

9.3B, 9.4B

8.13 There were no submissions in opposition to the proposed hazard classifications. Accordingly,

the proposed hazard classifications are unchanged.

Restriction to agricultural settings

8.14 It was proposed to restrict the use of paraquat to agricultural settings only, on the basis that

non-agricultural uses presented unnecessary exposure risk to sensitive individuals, and offered

no benefit.

8.15 Most submissions were in support of restricting the use of paraquat to agriculture. A number of

submitters advised that wording of this control would require particular attention, as not to

unintentionally prohibit uses such as for biosecurity, which were posited as having benefit.

Market Access Solutionz suggested that the proposal may unintentionally prevent use for

ornamental horticulture.

EPA staff response

8.16 Use of the word ‘agriculture’ in the restriction described in the application was deliberate, and

intended to cover horticulture and would be considered to cover ornamental horticulture. The

term ‘agriculture’ was also understood to include forestry. However, as with all of the proposed

controls, the resulting control and restriction on substances arises as a result of the combined

effects of a number of controls. For example, while forestry use may be allowed, those uses

would still need to comply with the other HSNO and HSW requirements (such as maximum

application rate restrictions, restrictions to use in workplaces only). We have no information to

confirm whether there would be any use in forestry sector at the proposed application rates and

frequencies.

8.17 Given that it is not clear whether forestry use would occur at the restricted application rates and

frequencies, the lack of support for paraquat use in forestry, as well as industry information14

that supports our understanding that paraquat (or other herbicides) are not routinely used in

forestry, we now propose that the term agriculture should not include forestry plantation uses.

This is on the basis that to do so would require additional forestry specific controls to be

imposed. We consider that forestry nursery uses should be included under the description of

agricultural use, as sapling production much more closely resembles horticultural crop

production and that the associated risks will be appropriately managed by the proposed

controls.

8.18 It is considered that that there could be benefit in the use of paraquat for biosecurity purposes.

Information provided by Biosecurity New Zealand indicate that paraquat is used for biosecurity

work. A further consideration is whether biosecurity use can be effective within the proposed

use restrictions (eg application rates, buffer zones). Information received from Biosecurity New

Zealand indicates that paraquat can be considered to offer some benefit. However, recent use

of paraquat for biosecurity purposes were outside of the proposed restrictions so those

restrictions are likely not appropriate to accommodate the required biosecurity uses.

14 https://assets.documentcloud.org/documents/6209512/NZIER-Report.pdf


https://assets.documentcloud.org/documents/6209512/NZIER-Report.pdf



8.19 Consequently, it is proposed that all biosecurity use of paraquat be excluded from the

restrictions imposed on agricultural use, instead making biosecurity use subject to obtaining a

section 95A permission. This would allow proposed use of paraquat to be assessed on a case-

by-case basis, and develop a set of conditions that is appropriate for the operation in question.

The permission would be anticipated to determine what applications rates and risk mitigations

are necessary to accommodate the specific biosecurity action. It should be noted, however, that

we have no indication of the resource implications that this requirement would impose on the

EPA, as we have no indications of the likely numbers of permission applications that could

arise.

8.20 We note that use outside of the proposed agricultural restrictions would still need to comply with

the relevant HSW provisions, even if carried out in accordance with any issued permission.

However, it is unlikely that the requirements of HSWA will be easily modified to accommodate

specific requirements of a biosecurity operation. We think that this needs careful consideration

when deciding whether to facilitate a permission-based regime for biosecurity uses, and in any

subsequent permission applications. The updated proposal is framed up to allow for permission-

restricted biosecurity use of paraquat.

Restrictions on application rates and frequencies

Application rate restrictions

8.21 It was proposed to restrict the maximum application rate of paraquat to 400 g ai/ha, once per

year, on the basis that this application rate allowed most use patterns and retained a level of

benefit for which unmitigated moderate risks to birds were acceptable. An application rate of

600 g ai/ha was identified to provide some further benefit, however would accordingly increase

the already outstanding risks to birds to unacceptable levels, considering the level of benefit

offered.

8.22 Submitters have asserted that 600 g ai/ha is required for use in lucerne, and that there is no

viable alternative for this use pattern. Many submitters have suggested that since risks to

operators were acceptable at 600 g ai/ha while wearing full PPE that that application rate

should be allowed, citing the human health risk assessment presented in the application.

8.23 The bird risk assessment was revised as a result of the information provided in submissions.

This is discussed briefly in Section 5, and included in its entirety in Appendix D.

EPA staff response

8.24 In light of information received through submissions, in particular the risk assessment provided

by Syngenta, we reviewed our proposal. Bearing in mind that our initial proposals were

presented as a position of balance that allowed a significant proportion of the beneficial effects

to be retained while offering some degree of environmental protection, we have refined our

assessment and revised our restriction proposals.

8.25 Our refined assessment indicates that use rates of up to 600 g ai/ha can be sufficiently

managed through additional restrictions so that the benefits associated with on-going paraquat

use can outweigh the residual risks (ie unmanaged risks to birds). We consider that allowing

use at higher application rates is expected to provide greater beneficial effects with a lower level

of environmental exposure than was previously presented in the Application for the lower

application rate of 400 g ai/ha.



Application frequency restrictions

8.26 More clarity has been requested on the number of applications per year, with submitters

suggesting this measure should be per season or crop cycle. In addition, multiple applications

per year were requested by a number of grower groups. Market Access Solutionz highlighted

the importance of multiple applications in kūmara, Federated Farmers requested multiple

applications for flexibility in use in seed crops.

EPA staff response

8.27 In response to allowing multiple applications, we are confident that multiple applications can be

accommodated. However, we consider that the maximum quantity of paraquat that should be

applied to any given location annually should be restricted to a maximum of 600 g ai/ha based

on paraquat ion. This is to limit the potential exposures presented by use of paraquat at the

maximum single application rate, when applied multiple times within a given time period (ie per

calendar year). The combined effect of these two application rate restrictions is to provide a

degree of flexibility in regard to how many applications of paraquat products can be applied,

whilst providing a cap on the quantity that is discharged to any given location over the specified

time period in order to limit exposures.

8.28 We remain of the position that risks to birds are outstanding and that any increase in the

quantity applied over the modelled scenario would lead to an increase in the residual risk to

birds. The refined risk assessment factors in birds not exclusively feeding from treated fields.

Paraquat is sprayed directly on some seed crops as a pre-harvest desiccant (eg clover seed,

plantain seed) which are considered desirable food sources for some birds. If the application

rate restrictions is phrased on a “per crop cycle” or “per growing season” basis, then this has

potential to result in a greater quantity of paraquat being applied compared to the modelled

scenario. However, we consider this is resolved by combining the two limits on paraquat

application (ie single and annual application).

Buffer zones

8.29 The Department of Conservation note that even at application rates for which no buffer zone

would be proposed, the modelling for these scenarios assumes an 8 m separation from the

spray area and a receptor. Examples of sensitive areas (such as residences, forests, and

schools) close to cropping areas (some less than 10 m) on which paraquat may be used with

the proposed controls, were submitted. With this consideration, the Department of Conservation

have suggested that buffer zones be set to protect sensitive areas, and that the buffers be

implemented whether or not the sensitive areas are down-wind of spraying activities.

EPA staff response

8.30 There were no proposed buffer zones to protect bystanders in the application proposals as it

was considered that any bystander exposure would be sufficiently managed through the

restriction to agricultural use only.

8.31 The buffer zones proposed have been identified in our assessment as being necessary to

mitigate identified risks, either environmental or to the health of bystanders. Consequently, we

do not consider that it is necessary to expand the requirements for buffer zones to include all

sensitive sites. We do note, however, that there are requirements in regional plans, either citing

specific spray plan requirements or by reference to the New Zealand Standard on Management

of Agrichemicals, NZS8409:2004 that require specific consideration of sensitive areas in the




proximity of the application area, so applicators will have to ensure that they comply with their

local obligations over and above the HSNO requirements.

8.32 A summary of the downwind buffer zones calculated in the application science assessment is

presented in Table 4.

Table 4: Downwind buffer zones which would be required for application rates of 400 g ai/ha and 600 g ai/ha

Maximum application rate (AR) /

g ai/ha

Application method Sensitive receptor AR ≤ 400 400 < AR ≤ 600

All ground-based

applications,

excluding use of non-

motorised handheld

equipment


Non-target plants (non-

threatened)

Nil 5 m

Non-target plants

(threatened)

5 m 5 m

All aerial applications Aquatic 5 m 15 m


threatened)

40 m 40 m

Non-target plants

(threatened)

60 m 100 m

Droplet size

8.33 The environmental risk assessment calculated the acceptable application parameters assuming

coarse droplets for ground-based application, and coarse to very coarse droplets for aerial

application.

8.34 The revised environmental risk assessment presented in Appendix D also calculated the

acceptable application parameters assuming coarse droplets for ground-based application, and

coarse to very coarse droplets for aerial application.

8.35 It is noted that droplets that are larger than coarse present reduced risk associated with spray

drift. We consider the use of droplets larger than those specified for both ground-based and

aerial application is acceptable, and intended in the proposed control wording presented in

Table 7.

8.36 Accordingly it is still proposed that application must be performed using coarse droplets for

ground-based application, and coarse to very coarse droplets for aerial application.

Prohibition of hand-held application

8.37 It was proposed to prohibit the application of paraquat using hand-held methods, on the basis

that this application method presents significant risk, and offers no benefit. The hand-held

application operator model showed that risks to the operator were acceptable with application

rates up to 390 g ai/ha with full PPE, however, this did not capture the concerns relating to

accidental exposures which may result from leakages or equipment malfunctions. Such



exposures have been identified in recent reviews of paraquat by the competent authorities in

the US and Canada.

8.38 Additionally, hand-held use was considered non-essential, given the availability of other

herbicides which may be used for spot treatments, and the use pattern was considered to offer

no additional benefit.

8.39 Submitters were largely opposed to this restriction, including Potatoes NZ, Market Access

Solutionz, and Horticulture NZ. The following points were raised in opposition to this restriction:

the hand-held application operator risk assessment showed that risks to operators wearing full

PPE at application rates up to 390 g ai/ha were acceptable;

less active ingredient is used, and accordingly there is less risk of spray drift in comparison to

boom spray;

hand-held use allows more targeted spraying so there is less risk of crop damage;

potential use of leaky / non-compliant equipment should not be reason for setting a control;

hand-held application assists in resistance prevention by allowing applicators to target weeds

which may survive a boom spray;

hand-held application may be the only equipment available for small area operations.

8.40 Syngenta also noted that they are developing a modification to knapsack sprayers that

eliminates the need for mixing, which is performed in situ within the spray equipment

immediately prior to discharge, which is claimed to eliminate the possibility of operator exposure

to the concentrate product.

8.41 The Department of Conservation highlighted that the US EPA have imposed risk mitigation

measures requiring all paraquat non-bulk (less than 120 gallon (454 L)) end use product

containers must comply with closed system requirements.

EPA staff response

8.42 The benefits of hand-held use identified by submitters are recognised as valid, with special

regard to the use of hand-held equipment for resistance management. It is noted, however, that

other herbicides could be used to treat weeds that have survived boom-spray application of

paraquat, though it may be beneficial to use paraquat to treat weeds that have survived boom-

spray application of other herbicides.

8.43 The revised operator risk assessment, which incorporates information provided by Syngenta,

suggests that application rates up to 600 g ai/ha applied via hand-held methods are acceptable.

For further discussion see Appendix D.

8.44 In a situation where faulty equipment or insufficient PPE is used, acute exposure to paraquat

from hand-held use is still a concern. Exposures reported to the National Poisons Centre

between 2002 and 2016 include exposures arising from insufficient PPE.

8.45 This control was framed in the Application as being within the jurisdiction of the EPA. Following

further discussion with WorkSafe, we consider that this proposed control and the risks it is

intended to mitigate are within the responsibility of WorkSafe and workplace health and safety.




Consequently, we no longer propose to include a restriction that prohibits use of hand-held

application of paraquat in the application method restrictions control (see Table 7) under HSNO.

8.46 Accordingly, WorkSafe may have considerations on whether or not to implement this by way of

Safe Work Instrument (SWI). We note with interest, however, the development of enhanced

spray equipment with a focus on elimination of risks to operators through closed mixing and

loading, which could be a mechanism to minimise operator exposures through mixing and

loading.

Labels to include specific statements regarding conditions to avoid

8.47 In addition to label requirements which relate to maximum application rates, droplet size, and

buffer zones, it was proposed to require the following label statements:

DO NOT apply when wind speeds are less than 3 kph or more than 20 kph as measured at

the application site.

To reduce runoff from treated areas into aquatic habitats avoid application to areas with a

moderate to steep slope, compacted soil, or clay.

Avoid application when heavy rain is forecast.

Do not transfer this product into food or drinks containers, or into unlabelled containers.

8.48 Syngenta submitted that they agree with the inclusion of specific label statements that promote

best practice in the safe handling and use of paraquat to protect people and the environment,

including the statements relating to wind speed and to not transferring the product into food or

drink containers, or into unlabelled containers. Syngenta also submitted that they do not believe

it is necessary to include the label statements related to runoff and heavy rain, citing that there

is no risk of runoff due to the strong adsorption of paraquat to soil.

8.49 The Department of Conservation in their submission highlighted that the US EPA require label

statements similar to the above food and drink container statement, in order to reduce the risk

of accidental consumption.

8.50 Market Access Solutions submitted that label statements outlining personal protective

equipment (PPE) requirements should be included on paraquat labels.

8.51 New Zealand Beekeeping Incorporated has suggested a label statement requirement for the

protection of bees.

EPA staff response

8.52 The proposal to include the label statements regarding runoff and heavy rain align with

requirements of overseas regulators such as the Pest Management Regulatory Authority

(PMRA) in Canada. We recognise that paraquat strongly adsorbs to soil upon contact, and

accordingly that introduction of paraquat into water ways from runoff is unlikely. We do not

consider that label statements regarding runoff and heavy rain are necessary. However, we

suggest that these precautions could be included in the Responsible Handling Information.

8.53 In regard to PPE requirements, we consider that Hazardous Substances (Labelling) Notice

already covers the requirement to specify appropriate PPE (see clause 13(2)) by reference to

the precautionary statements specified in the Global Harmonised System of Classification and

Labelling of Chemicals (GHS). We note that, from a risk-based perspective, we do not consider



the inhalation route to be significant and therefore would suggest that precautionary statements

on the label in regard to this exposure route are not necessary.

8.54 In regard to bee protection statements on the product labels, we note that the Hazardous

Substances (Hazardous Properties Controls) Notice and Hazardous Substances (Labelling)

Notice will apply to any retained approvals, requiring HSNO Class 9.4 substances (ie paraquat

products) to include statements to this effect.

Responsible Handling Information control (formerly product stewardship programme control)

8.55 This control was presented as a product stewardship programme in the Application. With further

thought, we consider that Responsible Handling Information is a more appropriate name for the

control. This control will be referred to as the Responsible Handling Information control herein.

8.56 We presented a high level description of the proposed Responsible Handling Information in the

application. The Responsible Handling Information was outlined in the application form as a

resource which would:

detail how to safely handle the substance through its lifecycle, from storage to disposal, and

provide information that is consistent with the controls imposed on the substance.

8.57 Some submitters indicated that they supported the concept of additional information provision,

others suggested that they were open to the idea of a product stewardship programme being

implemented, but would not indicate whether they support or oppose the control without further

information. Submitters suggested that the information in the points above is already available

on the product labels and safety data sheets of the substance. It was suggested that this control

should address an identified risk.

EPA staff response

8.58 Paraquat has been used in New Zealand since the 1960s. Accordingly there were concerns

with user compliance with any revised controls which may arise from this reassessment as

some existing commonplace uses may be non-compliant with the proposed restrictions.

8.59 The control as presented in the application form specified that product owners (ie, importers and

manufacturers) would produce, maintain, and make available a resource which details the

responsible handling of the substance through its lifecycle, and information of the controls

applicable. This was coupled with a control that required users to keep a record (in the form of a

declaration) stating that they have read and understood the information contained in the

programme (see paragraphs 8.62 to 8.67).

8.60 It is envisioned that the proposed Responsible Handling Information would ensure users were

aware of what they would need to do to comply with any new controls (and accordingly handle

the substances in a way that protects themselves and the environment), and understand the

importance behind complying with the controls. The Responsible Handling Information is a way

to bring all of the necessary responsible handling information together into one place, and allow

for greater detail and background provision than would be possible on product labels or safety

data sheets (SDSs). The Responsible Handling Information is not intended to replace label

information requirements or SDSs, rather enhance the level of information provided to ensure

that users are as well-informed as they can be, a function of content and availability.




8.61 As part of the suite of controls proposed in the application, the requirements of the proposed

Responsible Handling Information are detailed in Table 5. These proposed requirements are

listed as being mandatory, indicating that the resource must adhere to this requirement. Also

included in Table 5 are number of suggested elements, which, whilst not mandatory, are

considered to enhance the mandatory content.

Table 5. Details of proposed Responsible Handling Information performance criteria and content elements

Category Requirement Details (italicised text is proposed control wording)

Non-content

related criteria

Mandatory Information to promote compliant use

Any person importing or manufacturing the substance must ensure that the

information required to be provided is consistent with compliant use under the

requirements of the substance approval, and requirements specified under

HSW.

This will ensure that users have access to information that is current and will

support them in being able to follow the requirements for compliant use.

Mandatory Availability of information


information required to be provided is freely accessible to users, where

reasonably practicable.

This means that importers/manufacturers must do what they can, within the

bounds of reasonable practicability, to ensure that access to the Responsible

Handling Information remains available to users while their products are in

circulation in New Zealand. The responsibility of the importer/manufacturer is

to ensure that the required information is readily available free of charge, and

easily accessible.

It is acknowledged that importers/manufacturers can only control the

availability and provide access to the material, they would not be responsible

for ensuring that the information is provided to end-users.




Suggested Form of information

The form of the information to be provided is not prescribed, allowing product

owners to decide what works best for their set of circumstances. Examples of

information format could include:

Website

Document

Video/animations

Flyers / leaflets

Posters / infographics

It is also suggested that the availability of the responsible handling information

be identified on product labels or packaging. This could be achieved, for

example, by way of a label update, use of a cap sticker or additional packing

information provided with existing stock at point of sale.

General content Mandatory What has changed?


information required to be provided is, to the extent that is reasonably

practicable, is current and includes—

a summary of significant regulatory activity and any corresponding

changes; and

details of when changes come into effect.

This will ensure that key changes are highlighted to end-users, so that they

will be aware of how requirements have changed in comparison to current

use. It is also important that users are aware of implementation dates in

regard to when changes come into effect.





Mandatory Application restrictions


information required to be provided includes details of application restrictions,

and guidance on how to comply with those requirements, including (but not

limited to):

Application rate restrictions

Application equipment restrictions

Droplet size requirements

Use purpose restrictions (ie agricultural or biosecurity use only)

Requirement to obtain s 95A permission for biosecurity uses

The purpose of this information element is to ensure that key safe-handling

information is provided that relates to restrictions on application. This will

assist applicators to know the specific application restrictions that apply to on-

going use of paraquat herbicides. These restrictions are intended to protect

human health or the environment (or both). It is anticipated that the provided

information is sufficiently detailed so that it is clear to users what restrictions

apply for their intended use patterns.

Mandatory Disposal


information required to be provided includes details on how to appropriately

dispose of unwanted products or tank mixes.

In order to provide end-users all of the relevant lifecycle safe-handling

information, that includes how to dispose of unused concentrate or dilute

spray mix, we consider that the Responsible Handling Information should

include information on safe, compliant product disposal.

Mandatory Spillages


information required to be provided includes details on what to do in the event

of a spillage or other exposure event

In order to provide end-users all of the relevant lifecycle safe-handling

information, including how to deal with spillages of paraquat herbicides, we

consider that the Responsible Handling Information should include

information on safe-handling of spilled or contaminated material.




Mandatory Contact information


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.

We consider that the provided information should highlight to users how they

can get in contact with appropriate persons who can respond to paraquat-

product specific queries, in a non-emergency sense. This will allow users to

follow-up and seek answers to any resulting questions. It is not anticipated

that the contact details are for 24/7 responses, rather standard company

office hours contact details.

Suggested Use of paraquat: decision making

Guidance on the kinds of considerations users should take into account when

selecting a herbicide to use, and how to document the decision making

process.

Choosing to use paraquat herbicides is an important decision for a user to

make. This Responsible Handling Information could include a discussion on

the key considerations for choosing a particular product, and provide

information that will allow a user to identify when paraquat selection is

appropriate.

Human health-

specific content

Mandatory Safe handling information


information required to be provided includes

Information on the human health hazards and key exposure risks

associated with the paraquat substance and its intended uses

details of how users can handle the paraquat substance safely and

compliantly, throughout the lifecycle from storage to disposal.

This element is included as mandatory to ensure that specific information is

provided that details how users should safely handle the paraquat substance.

Mandatory Avoiding ingestion


information required to be provided includes details of how to avoid ingestion

of paraquat, and actions to take in the event of ingestion.

Given the number of global incidents of poisoning as a consequence of

inadvertent ingestion, we consider that information should be provided in the

Responsible Handling Information detailing the precautions to take to avoid

such exposures.





Suggested WorkSafe requirements

It would be useful to include information on certain HSW requirements:

Use of closed cab technologies

Use of closed mixing and loading systems

Licensing and training requirements

Requirements for health monitoring.

One of the key benefits of a product stewardship programme is that it

represents a ‘one-stop-shop’ for regulatory and handling information. We

consider that it is appropriate that the Responsible Handling Information

should highlight key the HSW requirements that users need to be aware of.

Environmental-

content

Mandatory Protection of water bodies


information required to be provided includes details of how to protect water

bodies from paraquat contamination, including (but not limited to) buffer zone

requirements.

We consider this element should include a description of buffer zones, and

requirements for use of buffer zones, what sizes, how to establish, etc.

Additionally, the droplet size restriction is a key preventative measure for

managing aquatic exposure to paraquat, and should be discussed in this

element.

Mandatory Protection of birds


information required to be provided includes details of measures that should

be implemented to minimise risks to birds.

Mandatory Protection of bees


information required to be provided includes details of measures necessary to

protect bees.

There are requirements in the HPC Notice that are in place to protect bees

and other invertebrate pollinators from exposure to hazardous substances.

We consider that this element should identify these requirements and inform

users how these restrictions apply to use of paraquat herbicides.

Requirement for additional records

8.62 It was proposed that users of paraquat would be required produce a written declaration of

understanding in their records of use, indicating that they have read and understood the

information in the Responsible Handling Information, and of the change of controls which (may)

apply as a result of this reassessment.



8.63 Submitters were generally opposed to this control. Submissions from grower organisations

argued that this requirement is an additional administrative burden, and did not serve to mitigate

any outstanding risk. Market Access Solutionz also suggest that grower magazines are an

appropriate way to communicate changes to controls following reassessment. Additionally

Federated Farmers suggest that Growsafe certificates should suffice as evidence of

understanding.

8.64 In its submission, DoC suggests that paraquat use should be subject to reporting requirements

similar to that required for aquatic herbicides.

EPA staff response

8.65 It is considered that this type of additional record, while not being particularly onerous on

growers considering record keeping requirements relating to hazardous substances in the EPA

Notices, and WorkSafe Regulations, is not necessarily effective in managing a specific risk, and

that competent applicators will be aware of how to stay informed about changes in regulatory

requirements through their training.

8.66 Note that we do not consider that being Growsafe qualified is necessarily an indication that the

user is aware of the revised restrictions and controls, given that a user may have obtained the

Growsafe certification prior to the decision on this application and that Growsafe certification

has a validity period of five years.

8.67 We acknowledge that there are other means to communicate decisions and control changes

which may be the result of the reassessment, including the mechanisms suggested by some

submitters. We would consider that best practice imposes an obligation on users to maintain

their knowledge of the requirements that apply to use of paraquat, and that if this information is

made available by importers or manufacturers of the products that they use, then it is

appropriate for users to be familiar with that information.

8.68 In regard to a reporting requirement, we consider that the risks are sufficiently managed through

other controls and that this would be a significant administrative burden on users of paraquat.

Phasing in and out of proposals

8.69 The introduction of new controls, or modification to existing controls, need to be phased-in in

order to allow importers and manufacturers time to ensure that they are compliant with the new

requirements. It is unreasonable to expect that such significant changes can be implemented

immediately upon a decision being made. The phase-in periods proposed for different controls

are provided in Table 6.

8.70 Additionally, there are practical considerations to bear in mind if it is decided that an existing

approval will not be re-approved (ie “revoked”). Consideration of when importation and

manufacture is no longer permitted, as well as a consideration of what should happen to

existing stock-in-trade. The proposals are presented in Table 6.




Table 6 Phasing timings for proposals

Controls / proposal Proposed

timeframe to

take effect

Comments

Specification of

pesticide and veterinary

medicine actives

Immediate This is already a requirement under existing approval for the

active ingredient. It is proposed that this requirement continues

with immediate effect.

Prohibition on use of

substances

Immediate This is already a requirement under existing approval for the

active ingredient. It is proposed that this requirement continues

with immediate effect.

Impurity specification

control

Immediate The active ingredient impurity specifications are proposed to

become mandatory immediately from the date of decision for

substance imported or manufactured in New Zealand on or after

the date of the decision.

It is not proposed to retrospectively impose this as a requirement

for existing stock already in New Zealand circulation.

Requirements for

emetics and stenching

agents

Immediate These requirements are already in-effect. It is proposed that this

continues to be the case with immediate effect.

Updating safety data

sheets (SDSs)

6 months from

decision date

A consequence of the reassessment is that the Hazardous

Substances (Safety Data Sheet) Notice 2017 will apply to

substances that are reapproved. However, we are conscious that

there needs to be a transitional period to allow SDSs to be

updated to the requirements of the Notice. Consequently we

propose that a transitional period is provided that allows current

SDS requirements to be a sufficient means of compliance. This

transitional period is proposed to be 6 months, as it is considered

that SDS can be updated more easily that product labels and that

there is benefit to ensuring that this important safety information is

up to date as soon as is practicable.

Use and application

parameter restrictions

12 months from

decision date

These use restrictions are essential tools in terms of managing the

identified exposure risks. However, there are some considerations

in regard to how quickly such changes could be practically

communicated and implemented.

The minimum time to realistically expect users to become aware

of these restrictions would be 12 months, and it would be

beneficial to align these requirements with the availability of the

responsible handling information. Given that this would be 12

months ahead of the obligation to have updated labels on

products, this would require significant communication work to

ensure that users were made aware of the changes. This should

Application equipment

restrictions

Spray droplet

specification

Downwind Buffer Zones




timeframe to

take effect

Comments

be supplemented by additional information to be added to existing

stock held by suppliers (eg cap stickers) to inform of changes.

Although there would be some efficiency If these restrictions came

into effect after 24 months (as this would align with the proposed

updating of the product labels), this also means that the exposure

protection arising from these measures would not be realised for

two years. We do not consider this to be acceptable and that there

are other mechanisms to employ to best ensure that users are

aware of new requirements. We therefore propose the shorter

phase-in period of 12 months (as opposed to the 24 month

alternative).

Responsible Handling

Information

requirements

12 months from

decision date

Responsible Handling Information package development and

availability

Development of a package of responsible handling Information is

a fundamental mechanism to ensure that paraquat users are

aware of the revised controls for paraquat herbicides.

Consequently, the time taken to develop these information

packages need to be minimised in order to ensure that users have

access to up to date, relevant safety information.

It is proposed that the safety information be available ahead of the

updated product labels, with the intention that the safety

information would provide users with the up to date handling

information in the absence of an updated product label.

Information to accompany products prior to product labels being

updated

We consider that users need to be aware of the availability of the

Responsible Handling Information package, given that it is

proposed to make this available to align with use restrictions and

ahead of product labels being updated. To this end, it is proposed

that such information should be required to accompany products

from the time that the Responsible Handling Information for that

product is available (ie a phase-in of 12 months for this

requirement).

Note that this is intended solely as an interim measure and will no

longer be required once the product labels have been updated.

Revocation:

(a) Substance is no

(a) and (b): We consider that substances that are proposed to not be

reapproved (ie these approvals are effectively revoked) need to be

viewed in regard to further importation and manufacture, and also





timeframe to

take effect

Comments

longer approved for

import or manufacture

(b) Existing stocks to no

longer be in New

Zealand

12 months from

decision date

give consideration to how the revocation applies to stock already

in circulation.

It is impractical to expect that stock that is already in circulation in

New Zealand be disposed within a short timeframe after the

decision. For ease and simplicity, we propose aligning the

prohibition on further import or manufacture with the

disposal/removal from New Zealand date. This will allow existing

stocks to be used up in accordance with existing requirements,

and provide sufficient time to arrange for disposal or exportation of

the substances. In order to require remaining stocks to be

disposed of, a direction to dispose will be required under s 66.

It is proposed that the ‘take-effect’ date of a decision to decline to

approve further importation or manufacture, and the s 66 disposal

date be aligned to both take effect 12 months from the actual date

of decision. This time period is proposed in order to align with the

implementation date of the key restriction controls that are

proposed for the retained substances.

Label statements /

Modifications to product

labels

24 months from

decision date

It is understood that up to 24 months is a practical timeframe for

implementing label changes and propose that this represents an

appropriate timescale to ensure that product labels are updated to

detail the required information about the new controls.

Furthermore, a consequence of the reassessment is that the

Hazardous Substances (Labelling) Notice 2017 will apply to

substances that are reapproved. However, we are conscious that

there needs to be a transitional period to allow labels to be

updated to the requirements of the Notice and to reflect the

reassessment outcomes. Consequently we propose that a

transitional period is provided that allows the current labelling

requirements to be a sufficient means of compliance. This

transitional period is proposed to be 24 months, in order to align

with the proposed period to update labels.

Updating packaging 24 months from

decision date

A consequence of the reassessment is that the Hazardous

Substances (Packaging) Notice 2017 will apply to substances that

are reapproved. However, we are conscious that there needs to

be a transitional period to allow packaging to be updated to the

requirements of the Notice if required. Consequently we propose

that a transitional period is provided that allows compliance with

current packaging requirements to be a means of compliance with

the Notice requirements. This transitional period is proposed to be

24 months to align with the label update timeframe.



Proposed wording of controls

8.71 We have provided indicative proposed control wording in Table 7.

8.72 Note that in the application, a standalone labelling control was proposed. However, this

requirement is now proposed to be incorporated into each relevant control. Consequently, the

standalone labelling control is only required for labelling statements that are not accompanied

by a corresponding control.

8.73 Where a new control is proposed (compared to the existing approvals) phase-in periods are

proposed to be built into each control to make it clear when specific requirements come into

effect.

8.74 Note that the proposed control that prohibits application of the substance onto or into water is

now incorporated into the HPC Notice.15 Consequently, it is not included in Table 7.

15 clause 52(1).




Table 7 Indicative additional control wording

Control

number

Implementation

mechanism

Control wording

1 Control relating to the manufacturing specification notification requirements for the active

ingredient, paraquat

s77A 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;

(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—



Control

number

Implementation

mechanism

Control wording

(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.

2 Control relating to the restriction of uses of paraquat as a chemical

s77A 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.

3 Control relating to impurity specifications for the active ingredient used in paraquat-

containing products

s77A Impurity specification control

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.

4 Control relating to the emetic and stenching agents inclusion in paraquat-containing

products

s77A 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 ; and

- 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.




Control

number

Implementation

mechanism

Control wording

5

Controls relating to the use and application parameter restrictions of paraquat-containing

substances

HPC Notice,

clause 50(1), s77

Use and application parameter restrictions

(1) From [control phase-in date], 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 horticulture and agricultural

purposes, but does not include use for forestry plantation or

biosecurity purposes;

(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.

s77A Restrict use type

CONTROL

(1) From [control phase-in date]—

(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 horticulture and agricultural

purposes, but does not include use for forestry plantation or

biosecurity purposes;

(b) biosecurity purposes means use for operations carried out under

the Biosecurity Act.

LABEL STATEMENT

(3) From [label phase-in date]—

(a) a person must not supply this substance to any other person unless

the substance label shows information detailing the requirements of

(1)(a); 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 (3)(a).

s77A Requirement to obtain s95A permission for use of paraquat for

biosecurity purposes

(1) From [control phase-in date] no person may apply this substance for

biosecurity purposes unless that person first obtains a permission from



Control

number

Implementation

mechanism

Control wording

the Authority under section 95A of the Hazardous Substances and New

Organisms Act 1996.

(2) Biosecurity purposes in (1) means use for operations carried out under

the Biosecurity Act.

6, 7 Control restricting methods of application

s77A Restriction on method of application

CONTROL

(1) From [control phase-in date] 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.

LABEL STATEMENT



the substance label shows information detailing the requirements of

(1); and




8 Control relating to the implementation of downwind buffer zones

HPC Notice,

clause 51, s77

Downwind Buffer Zones

From [control phase-in date] 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.




Control

number

Implementation

mechanism

Control wording

Maximum application rate(AR) /

g ai/ha


All ground-based

applications:

- excluding use of

non-motorised

handheld equipment


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 Notice,

clause 25, s77

From [label phase-in date]–


the substance label shows information detailing the requirements

set out in the below table; and



requirements of (a).

Maximum application rate (AR) /

g ai/ha


All ground-based

applications:

- excluding use of

non-motorised

handheld equipment



threatened)

Nil 5 m

Non-target plants

(threatened)

5 m 5 m

All aerial applications Aquatic organisms 5 m 15 m


threatened)

40 m 40 m

Non-target plants

(threatened)

60 m 100 m

9 Control relating to provision of responsible handling information

s77A Responsible Handling Information package

CONTROL




Control

number

Implementation

mechanism

Control wording

(a) an importer or manufacturer of the substance must obtain or

prepare Responsible Handling Information;

(b) For the purposes of (1)(b), 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 (4); 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 [interim accompanying information phase-in date] until [label phase-

in date] 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”

LABEL STATEMENT



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


packaged substance is accompanied by the label required by (3)(a).

CONTENT REQUIREMENTS OF RESPONSIBLE HANDLING INFORMATION

(4) For the purposes of (1)(b)(iii)(A). mandatory content requirements are:

Topic 1 - What has changed?


information required to be provided is, to the extent that is reasonably

practicable, is current and includes—




Control

number

Implementation

mechanism

Control wording

(1) a summary of significant regulatory activity and any corresponding

changes; and

(2) details of when the changes identified in (1) take effect.

Topic 2 - Application restrictions


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


information required to be provided includes details on how to appropriately

dispose of unwanted products or tank mixes.

Topic 4 - Spillages


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


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


information required to be provided includes:

(1) Information on the human health hazards and key exposure risks

associated with the paraquat substance and its intended uses



Control

number

Implementation

mechanism

Control wording

(2) details of how users can handle the paraquat substance safely and

compliantly, throughout the lifecycle from storage to disposal.

Topic 7 - Avoiding ingestion


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


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


information required to be provided includes details of measures that should be

implemented to minimise risks to birds.

Topic 10 - Protection of bees


information required to be provided includes details of measures necessary to

protect bees.

10 Control relating to requirement to provide additional information on the product label

s77A Additional labelling requirements


(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”




Note: Buffer zones and application parameter restrictions required to be

included on product labels [EPA (Labelling) Notice 2017]

9 Overall evaluation and recommendation

9.1 As a consequence of the refinement to our risk assessment, we consider that the risks

presented through use rates of up to 600 g ai/ha are no greater, likely lower, than previously




described for rates up to 400 g ai/ha. Additionally, the level of benefit retained by increasing the

application rate restriction to 600 g ai/ha is increased.

9.2 Accordingly, we have adjusted our proposal, increasing the application rate restriction to

600 g ai/ha.

9.3 Our position on future approval status of the substances involved in this reassessment remains

unchanged:

Propose to re-approve substances HSR003041, HSR000447 and HSR000828, subject to

restrictions imposed through additional controls;

Propose to decline to re-approve substances HSR100443, HSR100572, HSR007847, and

HSR007854.

9.4 A detailed summary of the revised and final proposals is provided in Table 1.



Appendix A Controls tables for retained approvals

EPA Controls that apply to substances:

paraquat (HSR003041);

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

dichloride salt (HSR000447);

soluble concentrate containing 200 - 250 g/litre paraquat as the dichloride salt (HSR000828).

Control

code

Notice Control description Transitional period1

LAB EPA Labelling Notice

2017

Requirements for labelling of

hazardous substances

24 months from date of

decision

PKG EPA Packaging Notice

2017

Requirements for packaging of



decision

SDS EPA Safety Data Sheet

Notice 2017

Requirements for safety data sheets

for hazardous substances


decision

DIS EPA Disposal Notice

2017

Requirements for disposal of


-

HPC-1 EPA Hazardous

Property Controls Notice

2017 Part 1

Hazardous Property Controls

preliminary provisions

-

HPC-2 EPA Hazardous


2017 Part 2

Certain substances restricted to

workplaces only

-

HPC-3 EPA Hazardous


2017 Part 3

Hazardous substances in a place

other than a workplace

-

HPC-4A EPA Hazardous


2017 Part 4A

Site and storage controls for class 9

substances

-

HPC-4B EPA Hazardous


2017 Part 4B

Use of class 9 substances -

HPC-4C EPA Hazardous


2017 Part 4C

Qualifications required for

application of class 9 pesticides

-

Notes:

1 Within this time period, it is acceptable to comply with the controls in the approval as they relate to the

respective Notices according to the terms of the approval as in force immediately prior to the reassessment. If

no transitional period is specified, the Notice requirements take effect straight away upon decision.


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-Packaging-Notice-2017.pdf

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Safety-Data-Sheets-Notice-2017.pdf

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/EPA-Notices/Hazardous-Substances-Safety-Data-Sheets-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













HSNO Additional Controls and Modifications to Controls for paraquat (HSR003041)

HSNO Additional Controls and Modifications to Controls for:

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

as the dichloride salt (HSR000447);

soluble concentrate containing 200 - 250 g/litre paraquat as the dichloride salt (HSR000828)

Additional Control

Number

Control Description

1 Specification of pesticide and veterinary medicine actives

2 Prohibition on use of substances

See Table 7 for wording of additional HSNO controls

Additional Control

Number

Control Description

3 Impurity specification control

4 Requirements for emetics and stenching agents

5 Use and application parameter restrictions [+ label]

7 Spray droplet specification [+ label]

8 Downwind Buffer Zones [+ label]

9 Responsible Handling Information package

10 Further additional label statements

See Table 7 for wording of additional HSNO controls



HSW HS Requirements for:

paraquat (HSR003041);

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

dichloride salt (HSR000447);

soluble concentrate containing 200 - 250 g/litre paraquat as the dichloride salt (HSR000828).

Note: these requirements are not set for the substances covered by this reassessment 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 Extra information

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

containers

HSW2-2 Reg 2.5 - 2.10 Signage

HSW2-3 Reg 2.11 Safety data sheets

HSW2-4 Reg 2.12 - 2.14 Packaging

HSW3-1 Reg 3.1 Inventory

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

substances

HSW4-1 Reg 4.1 - 4.4 Compliance certificates for certified handlers

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

supervision

HSW5-2 Reg 5.6 - 5.13 Emergency response plans

HSW13-1 Reg 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 Reg 13.9, 13.11 Certain substances to be under personal

control of certified handler or secured

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

substances

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

tolerable exposure limit

HSW13-9 Reg 13.18 Duty of PCBU to ensure prescribed exposure

standards for class 6 substances not

exceeded


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


















Code Regulation Description Extra information

HSW13-13 Reg 13.26 - 13.29,

13.34 - 13.37

Storage and segregation of certain class 6 or

8 substances

HSW13-14 Reg 13.30 - 33 Secondary containment requirements for

class 6 and 8 pooling substances

HSW13-15 Reg 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 Reg 13.40 - 13.44 Separation of hazardous substance locations

holding class 6 and 8 substances

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





















Appendix B Updates to economic report

See document titled APP203301_Update_Report_Appendix_B_updates_to_the_economic_report.pdf





Appendix C Updates to the human health risk assessment

Response to Syngenta comment in regard to additional controls numbers 5 and 6.

1. The results of the EPA modelling assessing the human health risk associated with chronic

exposure to paraquat from either its application with a boom or knapsack indicated that an

application maximum rate of 600 g ai/ha (boom) and 390 g ai/ha (knapsack) would not pose a

significant risk (RQ = ~1) as long as appropriate personal protection (PPE) were utilised [Full PPE

during mixing, loading and application (including FP2, P2 and similar respirator achieving 90%

inhalation exposure reduction)].

2. Syngenta advocates that knapsack application methods should not be eliminated as they do not

pose an unmanageable risk and that respiratory protection is not needed. Syngenta noted that the

modelling methodology the EPA utilised was likely overly conservative and as such they provided

a “higher tier” assessment for both boom and knapsack application methods. They concluded that

paraquat products can be applied with minimal health risk at rates up to 600 g ai/ha by either

method. And that “There should be no unacceptable exposure (associated with paraquat

absorption) in operators using a tractor-mounted sprayer even in circumstances when protective

precautions are not always followed.” This latter conclusion is stated in support of their comment

that closed cabs on tractors should not be a required exposure control.

3. They noted conservatism in the model first starts from the cotton matrices used to collect

pesticide residues that have a much higher absorption potential than skin, so taking these residue

values as the true skin deposit leads to conservative assumptions on systemic exposure potential.

They also noted that the model has cumulative conservatism as a result of aggregating each of

the 75th percentiles for body part exposures from the mixing, loading, and application activities

that also ultimately create an overly exposed ‘artificial operator’.

4. Their risk assessment also took into account specific paraquat physical-chemical properties and

specific properties associated with its application that indicate respiratory exposure, which is

incorporated in the results of our modelling, are not a relevant route of exposure for paraquat and

should essentially be excluded from the cumulative exposure total used in assessing the risk.

(This is discussed in more detail below in the Boom Application Discussion).

5. In addition, they noted that the modelling methodology to assess systemic exposure from dermal

absorption is contrary to what actually occurs in the “real world” relative to the absorption of

chemicals and consequently leads to a higher estimated systemic exposure value. In reality, the

total dermal exposure of the operator is not incurred at time-zero as occurs in the model but

occurs sporadically throughout the working day, building up to the estimated daily dermal

exposure level. Therefore, the percent of applied dose measured in the laboratory absorption

study over-estimates that which occurs in the operator because of the longer duration of skin

contact with the total dose in the laboratory. This is a major issue for slow skin penetrants such as

paraquat, which tend to have long ‘lag phases’ during which the rate of absorption is increasing

up to a steady-state rate. This again adds to the EPA’s exposure conservatism by this route.

6. Their belief that our modelling over estimated true exposures was corroborated with biomonitoring

data from the application of paraquat using both boom and knapsacks. Evidence from health

monitoring and epidemiology studies were also supplied to the EPA to support their conclusions

that the “real life” application of paraquat has not to date shown significant evidence of chronic

health risk.



7. Syngenta noted they have been working with an engineering design company to develop a fully

closed loop delivery system that can be retrofitted to all knapsack sprayers. This system is

designed to eliminate exposure to the concentrate product. It also complements proposals for a

future closed transfer system approach for mixing/loading with tractor based systems, ensuring

such systems also exist for hand-held application. The EPA is in full support of any technological

advancement that further limits exposure to reduce health risk.

Boom Application Discussion

8. The EPA agree that our inhalation and dermal exposure modelling of paraquat from boom

application methods yielded conservative results. The EPA are in agreement with Syngenta that

exposure from inhalation would be very minimal yet it was factored into the potential total

exposure to the operator in the model used by the EPA.

9. The conclusion that inhalation should not be a meaningful exposure route is based on predictive

models that assume 100% absorption, retention, and systemic absorption of the estimated

inhalation exposure. However, paraquat has a very low vapour pressure and therefore on its own,

or as a component of aqueous formulations, it poses no direct inhalation risk in handling the

formulation concentrate. The only situation where the operator is potentially in direct contact with

the undiluted product is for mixing/loading where the product container is opened and the content

poured into the spray tank or into the induction filling system of the sprayer. During this operation

no spray is produced. Therefore, there is essentially no inhalation hazard risks when an operator

handles the formulation concentrate. Based on the low vapour pressure of paraquat, operator

exposure from volatilized paraquat in the air after spray application is negligible too.

10. Respiratory exposure to paraquat during spray applications is very low because the large spray

droplet size prevents the material from going beyond the nasal cavity if inhaled. An analysis for

aqueous non-selective herbicides shows that under circumstances of use, relatively large

particles are produced (200-400 µm) by the spray equipment (Chester, 1998). These are required

to achieve optimum coverage of target plants and to reduce spray drift. Inhalation theory supports

the fact that large droplets do not pose an inhalation risk since they are not respirable (capable of

reaching the alveoli or extreme distal portions of the lungs) and are therefore trapped in the nasal

cavity or upper respiratory tract and are then orally absorbed (Hext, 2002). For paraquat

specifically, only a small fraction (12 - 15%) of the orally absorbed paraquat will be systemically

absorbed (Silcock and Mainwaring, 2007). A spray droplet size specification for coarse droplets

only is a proposed control.

11. Due to paraquat’s herbicidal activity extreme care must be taken to ensure that off-target drift is

minimized. Treatment is recommended when there is little or no wind, and spray is directed at the

ground away from the operator in all cases. The combination of these factors makes inhalation

exposure to paraquat vapour/mist very unlikely. The reduced drift also reduces dermal exposure

potential.

12. As seen below in Table 1, estimated operator exposure modelled using a 600 g ai/ha application

rate without respiratory protection is 0.0013 mg/kg bw/day while it is 0.0008 – 0.0007 mg/kg

bw/day with respiratory protection at the two different levels of filtration modelled (ie, removal of

75 or 90% of the inhalable fraction). Since this “filtration” is not relevant, the true exposure is likely

to be closer to that of the maximum filtration value, ie, 0.0007 mg/kg bw/day which is equal the

AOEL.

13. Syngenta commented that the EPA should also have utilised a dermal absorption value of 0.3%

instead of 0.4% based on the results of Wester et al. 1984. The EPA utilised 0.4% based on




EFSA recommendation (EFSA 2012) to add one SD to an absorption average when variation of

the mean is >25% to cover the upper 84th percentile. This addition to the absorption value brings

into the equation another level of conservatism as can be seen in Table 1 where exposure

estimates based on an absorption percentage of 0.3% are also presented.

14. Thus, due to essentially an inherent absence of a respiratory exposure component, the EPA

believe there is no need for an inclusion of a control to protect against this exposure route to

minimise risk as the RQ is <1. This is further highlighted when the extra conservatism the EPA

used in modelling dermal absorption ie, the average percent absorption plus a SD (0.4%) versus

use of only the average percent absorption value (0.3%) is modelled, and the RQ goes even

lower.

Table 1. Estimated exposure to paraquat for 70 kg operator as predicted from the UK PSDs

interpretation of the BBA Model and associated RQ estimates based on an AOEL of (0.0007

mg/kg)

Exposure scenario – Boom application (600 g ai/ha, 50 ha,

8 hrs)

Estimated operator

exposure (mg/kg bw/day)

Risk

Quotient

No PPE during mixing, loading and application 0.0083 11.85

Gloves only during mixing and loading 0.0046 6.56

Gloves only during application 0.0077 11.02

Full PPE during mixing, loading and application (excluding

respirator)

0.0013 1.86 /

1.64*

Full PPE during mixing, loading and application (including FP1,

P1 and similar respirator achieving 75 % inhalation exposure

reduction)

0.0008 1.13 /

0.91*



reduction)

0.0007 0.98 /

0.76*

*This value is the RQ based on use of a 0.3% dermal absorption as recommended by Syngenta

15. The likelihood that boom exposure at the EPA proposed maximum of 600 g ai/ha would not result

in significant exposures even in the absence of respiratory PPE is also supported by a robust

biomonitoring study conducted in the United States (Meier, 1995).

16. In the study by Meier, paraquat was applied by 17 operators using open cab tractors with

mounted spray booms at an application rate of 1000 g ai/ha. The application area averaged ~12

ha (3 - 30 ha) and the average time spent mixing, loading and applying was ~6.75 hours (3.8 -

11). [Note: EPA modelling utilised a 50 ha application area, 8 hours of exposure and a 600 g ai/ha

application rate]. The total dose of paraquat absorbed by the operators was measured by

collecting 24-hour urine samples on the day of exposure then daily for the ensuing 5 days after

application (see Table 2). Of these 17 operators:

2 used PPE during mixing, filling, and application

6 used PPE (gloves, or gloves plus apron) only during mixing and filling



9 did not wear any PPE during mixing and filling or application

None of the 17 utilised respiratory protection at any time during the whole process

Table 2 Results of the biomonitoring study by Meier 1997

PPE use scenario PPE during mixing,

filling, and

application (no

respirator)

PPE during mixing

and loading / No

PPE during

application

No PPE at

any time

Number of Applicators 2 6 [4 (gloves), 2

(gloves, face shield,

apron)]

9

Avg application area (ha) 7.5 10.2 13

Avg time mixing and loading (min) 31 37 56

Avg amount of formula handled (L) 28.4 34.8 48.5

Avg exposure duration (min) 407 328 362

Average exposure (mg/kg bw/day) <LOD <LOD 0.000152

RQ [exposure/AOEL( 0.0007 mg/kg bw/day)] 0.131 0.171 0.21

1.) No paraquat was detected in the urine from these 8 people. The RQ value was derived by using the urine limit of detection value (5 ng/ml) to estimate the daily mg/kg bw dose.

2.) 3 of the 9 samples were <LOD

17. The results of this study showed operators using PPE during mixing, loading, and or during

application significantly decreased their exposure potentials and that, even in the absence of PPE

being worn during application for 15 of the 17 operators, exposures were well below the AOEL.

Even in the absence of the use of any PPE at any time, three of nine operators showed no

evidence of exposure.

Boom conclusion

18. The EPA modelling data in Table 1 reinforced by the biomonitoring data support a conclusion that

the use of PPE during mixing, loading, and application is important to prevent exposure to

paraquat; and that inhalation is not a meaningful route of exposure and contributes very little to

the overall potential paraquat exposure. It is important to note that paraquat is classified for both

skin and eye irritancy hazards and PPE should be worn to protect against these hazards. Based

on the accepted conservatism of the EPA’s dermal exposure modelling, the EPA believe use of

standard PPE, without respiratory protection, is sufficient to manage exposure risks associated

with a 600 g ai/ha maximum application rate.

Knapsack Application Discussion

19. In the original EPA assessment it was determined that paraquat could be applied at a rate of 390

g ai/ha with minimal risk using a knapsack provided full PPE plus maximum respiratory protection

was worn during mixing, loading, and application (Table 3). Nonetheless the EPA has proposed to

prohibit hand-held application methods (ie, handgun, knapsack application). The EPA considered




that hand-held uses were not essential given the availability of other herbicides that can be used

for spot-treatments and present significant risks arising from the close-proximity of applicator to

point of release, and unavoidable contact with spray equipment. The EPA considers these risks

can be readily avoided by prohibiting hand-held uses.



mg/kg)

Exposure scenario – Knapsack (390 g ai/ha, 1 ha, 8 hrs) Estimated operator


Risk

Quotient





respirator)

0.0025 3.52



reduction)

0.0010 1.43



reduction)

0.000708 1.01

20. Syngenta, as well as other submitters, believe knapsack application methods are important and

should not be prohibited. Syngenta noted the modelling used by the EPA was that for upward

spraying which would exaggerate exposure and provided modelling results of a 600 g ai/ha

application from a knapsack to 1 ha using downward spraying assuming a 0.3% absorption rate

(Table 4).

Table 4. Estimated exposure to paraquat (600 g ai/ha) as predicted from the German model (geometric mean values) PSD version 03

PPE Dermal exposure

(mg/kg bw/d)

Inhalation

exposure

(mg/kg bw/d)

Total exposure

(mg/kg bw/d) RQ

Mixing/Loading: Gloves Application:

Coveralls and sturdy footwear, protective

gloves and facemask (FFP2 or P2)

0.000252 0.000557 0.000806 1.15

Mixing/Loading: Gloves and facemask

(FFP2 or P2) Application: Coveralls and

sturdy footwear, protective gloves and

facemask (FFP2 or P2)

0.000252 0.00015 0.000398 0.569



21. The EPA agree with Syngenta in that our modelling results err on the side of conservatism,

especially as noted from the fact that the data for hand held application in the model were

collected solely from studies where upward spraying of plant protection products was carried out.

The upward spraying conditions modelled in this application scenario are very likely to

significantly over predict the exposure potential via the dermal route as it would factor in exposure

to the upper torso, head, and arms compared to when the point of emission is below waist level.

In addition, the same arguments discussed above in regard to the impact of the dermal absorption

kinetics in regard to dermal loading of the pesticide are applicable to this scenario too.

22. The upward spraying scenario would also lead to a much greater potential for inhalation

exposure. This is demonstrated by the 3.5 (5.41/1.56) fold reduction in the RQ value with the

addition of respiratory protection removing 90% of the modelled inhalable fraction compared to a

boom where the reduction ratio is only 1.9 (1.86/0.98) (see Table 1). It is also believed that the

importance of a lack of volatility and the generation of large particle sizes relative to exposure the

total exposure contribution would also apply. Accordingly, If the inhalation exposure impact is

factored out by 90%, even a 600 g ai/ha application rate yields an RQ value of 1.56 (Table 5).

This RQ was also generated from the dermal exposure potential estimated from upward spraying.



mg/kg)

Exposure scenario – Knapsack (600 g ai/ha1 ha, 8 hrs) Estimated operator


Risk

Quotient





respirator)

0.0038 5.41 /

5.13*



reduction)

0.001539 2.20 /

1.92*



reduction)

0.001089 1.56 /

1.27*

*This value is the RQ based on use of a 0.3% dermal absorption as recommended by Syngenta

23. Similar to the boom discussion the applicant has submitted the results of three biomonitoring

studies assessing paraquat exposure in workers applying the herbicide using knapsacks.




Study 1: Findlay, et al. 1998

24. This appears to be a well-conducted and documented study in which 20 workers sprayed ~12

tank loads (18 L capacity) over approximately a six-hour period using an application rate of 600 –

800 g ai/ha. Urine was collected for 7 days following application with a level of quantification at

0.75 ng/ml. Workers were all noted to have showered after treatment. Some minor hygiene

deviations were noted with an occasional worker not putting gloves and a face shield on when

mixing and loading. Some workers were noted to also have splashes on their back from improper

closure of the sprayer lid (A dye had been added to paraquat formulations to help in identifying

this risk.). Workers were noted to have worn a single layer of cotton clothing, socks and rubber

boots (no respiratory protection was worn). The geometric exposure mean was 77 ng/kg bw/day

(<LLOQ – 408 ng/kg bw/day) and the arithmetic mean was 149 ng/kg bw/day. The AOEL is

0.0007 mg/k bw/day (or 700 ng/kg bw/day). Thus, all workers were well under the AOEL without

the benefit of any respiratory PPE or chemical resistant clothing during application.

Study 2: Chester, et al. 1989

25. This appears to be a well-conducted and documented study in which paraquat was applied to kill

weeds in a Sri Lankan tea plantation. This study was conducted in association with an

epidemiological study to assess the potential presence of long-term effects from paraquat

spraying. Dermal exposure was measured using a “whole body” collection method in which

workers wore exposure sampling garments (WHO, 1982). paraquat was applied at a

concentration yielding an application rate of 140 g ai/ha. Due to terrain this amounted to about 7-8

tank loads/day. In this study 12 workers (2 mixers and loaders and 10 sprayers) were assessed

for dermal absorption following 5 days of application using daily urine sampling and blood

sampling on Days 1, 3, and 5, and the day after the last day of spraying. The mixer loaders diluted

the herbicide in large drums using stream water that flowed next to them stirring it with a stick and

then using buckets to transfer the solution into the sprayers’ backpacks. The normal work clothing

of all workers consisted of short-sleeved shirt, shorts, and no socks or shoes. Mixer loaders often

were standing in the stream and were able to wash off any spillage. The total estimated dermal

exposure levels for the mixers and loaders was 66 and 74 mg of paraquat ion respectively.

Despite these dermal exposure levels, no paraquat was identified in any urine or serum sample

(LOD was 30 and 6 ng ion/ml, respectively). This finding was attributed to the very low

concentration of paraquat in the spray solutions, the high standard of personal hygiene exercised

by workers and the low skin permeability of paraquat to be absorbed.

26. It was noted though that if the average daily urine volume (1.94 L) were related back to the limit of

detection (0.03 µg/ml), the average amount of paraquat excreted would have been ~58.2 µg /day

(usually a a value of ½ the LOD is used). This amount divided by the average body weight (53.4

kg) yields a “worst-case” daily dose of 1.09 µg/kg. Put into the context of the AOEL of 0.0007

mg/kg/day gives an RQ ratio of 1.56. Thus, the amount of paraquat these workers were likely

exposed to was below the RQ even in the absence of any PPE since this estimate was based on

the findings below the LOD. The value of this study is also limited by the application rate of 140 g

ai/ha.

Study 3: Swan, 1969

27. This study reported the results from a trial in 1965 and 2 trials in 1967. paraquat was applied to kill

weeds in rubber plantations in Malaysia.

28. In the 1965 trial 6 workers sprayed paraquat formulations 6 days per week for 12 weeks. paraquat

was applied at a concentration of 1:400 (0.5 g/L) yielding an application rate of ~225 g ai/ha.

These workers were not involved in the mixing and loading of product, ie, they just applied it.



Clothing consisted of a singlet T-shirt, trousers tucked inside of socks and canvas or leather

shoes. Workers applied the spray in front of them always moving through sprayed area.

29. The 1967 investigation was designed to show which route of exposure was most important in

determining absorption of the traces of paraquat found in the urine from the 1965 trial. This trial

consisted of four teams of six workers. One wearing normal clothing and the other three using

various combinations of PPE (knee-length gum boots, face mask, and rubber gloves).

30. Urine samples collected in both trials had a limit of detection of between 0.01 - 0.02 ppm (10 - 20

ng/ml. Medical examinations and chest radiographs were also conducted to assess health effects.

31. Urine sample results from the 1965 study showed that, except for one person found to have 0.32

ppm on one occasion, most samples contained less than 0.1 ppm, and it was not detected in 56

of 134 samples. In the 1967 trials the amount found in urine decreased in the normal clothed

individuals and those wearing some level of PPE seldom had detectable levels. It was noted that

in a total of 394 samples paraquat was detected in only 53 of them with the highest value being

0.15 ppm in a normal clothed worker.

32. Results from this study are hard to interpret as pertinent information in study detail was not

available to quantify the workers’ mg/kg bw/day dose. Furthermore, the applicability of these data

is limited as they were spraying tall weeds, sometimes walking up hill into the spray. Several

workers on occasion exhibited clinical signs related to irritation. Nonetheless, a significant number

of workers applying paraquat, often without the benefit of any PPE, showed minimal evidence of

paraquat exposure.

Knapsack Conclusion

33. The EPA believe that the quantitative modelling initially utilised produced a conservative exposure

result, yet still was able to deem an application rate of 390 g ai/ha to have minimal risk. From a

qualitative perspective it would be believed that when you factor out the exposure from the

upward spray pattern and the contribution from inhalation that this model incorporates the

exposure from an application rate of 600 g ai/ha should be deemed as low risk. This conclusion is

validated by the results of the modelling conducted by Syngenta showing RQ values of less than

1 following the application of paraquat at a rate of 600 g ai/ha using full PPE except respiratory

protection, and the results of the Findlay (1998) study whose results demonstrated minimal

paraquat exposure in 20 workers using an application rate of 600 – 800 g ai/ha.

Epidemiology

34. In addition, Syngenta provided the results of 2 epidemiology studies assessing the impact of

paraquat on lung health in farm workers (Castro-Gutierrez, et al., 1997 and Dalvie, et al., 1999). In

general, the results of both studies indicated the chronic use of paraquat has not resulted in

readily identifiable adverse effects in lung function. This conclusion is highlighted by a comment in

the manuscript by Dalvie in which he states “Of the few epidemiological studies investigating

respiratory effects, only Gutierrez et al. who investigated workers in a Nicaraguan banana

plantation, found exposure to the herbicide to be related to respiratory symptoms. All others12–16

found no associations with symptoms, spirometry, or gas transfer. Earlier study limitations include

poor exposure characterisation (duration only, and inability to distinguish long term from acute

exposure), and insensitive outcome measurements.”

35. The Castro-Gutierrez paper examined 134 farm workers in Nicaragua who used knapsack

sprayers and compared them to 152 unexposed workers. It was noted that 53% of the exposed

population had suffered exposure rashes, 25% epistaxis (nose-bleeds), and 42% had paraquat




splashes in their eyes. Thus, these workers practiced extremely poor hygiene procedures during

its application. Their study indicated an increase in dyspnea that correlated with intensity of

exposure based on history of paraquat -induced skin rashes and burns. However, this

symptomology correlation was not manifested by changes in objective measures of lung function

such as forced expiratory volume in one second (FEV1.0) or forced vital capacity (FVC).

36. The only finding Dalvie noted in 62 sprayer workers in South Africa and 70 controls was a

significant difference between measures of long term exposure to paraquat and arterial oxygen

desaturation during exercise independent of short term paraquat exposure. The significance of

this one finding in light of the other numerous parameters they assessed that showed no effects is

of uncertain relevance.

37. Overall, as a result of differences in work behaviours of the study workers relative to New Zealand

and the overall robustness of the studies the results of the epidemiological information extracted

from farm workers does not lend itself to any meaningful conclusions. Importantly, results in

general did not indicate the presence of adverse health effects from long-term use of paraquat

despite poor work hygiene practices.

Final Conclusions

1. The EPA is in agreement with Syngenta that the modelling utilised was overly conservative

(especially for knapsack analysis which modelled upward spraying) and thus yielded inflated

results relative to the likely “true” exposure. This conclusion is corroborated by the results

observed in the biomonitoring studies which indicated minimal exposure to applicators who

often used no to minimal PPE.

2. The EPA is in agreement with Syngenta that the basis for our excessive exposure estimates

comes from the inherent conservative default values utilised in the modelling, the contribution

of an inhalation component to the total exposure when it should not be, and how the model

incorporates dermal absorption kinetics compared to how they would likely operate in the field

with a molecule like paraquat.

3. The EPA is in agreement with Syngenta that because there should not be a significant

contribution to the overall exposure from inhalation, no controls should be put into place to

protect against this exposure route as they would be meaningless to their contribution to

decrease exposure.

4. Syngenta’s belief that the modelling should have incorporated an absorption percentage of

0.3% versus 0.4% is not believed by the EPA to be significant factor relative to its addition to

the conservative nature of our results. This conclusion is based on the fact that it does not

change the position of the EPA in its belief that paraquat could be applied with minimal risk at

a rate of 600 g ai/ha by either application method assessed.

5. The EPA believes appropriate PPE should be worn during the mixing, filling, and application of

paraquat to prevent dermal exposure and minimize risk. However, respiratory protection is not

deemed necessary as that is not a pertinent exposure route.

References

Castro-Gutierrez, N. (1997). Respiratory symptoms. Spirometry and chronic occupational paraquat

exposure. Scand. J. Work Environ. Health; 23:421-7.



Chester, G., et al. (1989). Paraquat: Dermal Exposure of, and Absorption by, Sri Lankan Tea

Plantation Workers. ICI Agrochemicals, Unpublished Report No. TMF 3189.

Chester, G. (1998) Droplet Size Distribution of Herbicide Sprays with Particular Reference to

Paraquat. Unpublished Position Statement.

Dalvie, M.A., et al. (1999). Long term Long term respiratory health effects of the herbicide, paraquat,

among workers in the Western Cape. Occup. Environ. Med.; 56:391–396 391

EFSA (2012) Guidance on dermal absorption. EFSA Panel on Plant Protection Products and their

Residues (PPR). EFSA Journal 2012;10(4):2665.

Findlay, M.L., et al. (1998). Paraquat: Worker Exposure During Mixing, Loading and Application of

‘Gramoxone’ with Knapsack Sprayers. Zeneca Ag Products Western Research Center, Unpublished

Report No. WER 004.

Hext, P.M. (2002). Toxicology Position Statement: The Inhalation Toxicity and Classification of Diquat

and Paraquat in Relation to Use Patterns. Syngenta Health Assessment and Environmental Safety

Meier, D.J. (1995). Paraquat: Worker Exposure During Mixing, Loading And Application Of

Gramoxone® Extra To Pecans Using Vehicle-Mounted, Groundboom Equipment. Zeneca Ag Products

Western Research Center, Unpublished Report No. RR 95-019B.

Silcock, R.C. and Mainwaring G.W. (2007.) Paraquat Oral Bioavailability Study in the Dog. Syngenta

CTL Alderley Park, Macclesfield Cheshire, SK10 4TJ, UK. Report No.: UD0938-REG; Study No.:

UD0938; Task Number: T003981-06

Swan, A.A.B. (1969). Exposure of spray operators to paraquat. Brit. J. Industr. Med.; 26, 322-329.




Appendix D Updates to the environmental risk assessment

See document titled

APP203301_Update_Report_Appendix_D_updates_to_the_environmental_risk_assessment.pdf
