Application for the reassessment of a hazardous substance Under Section 63 and Section 63A of the Hazardous Substances and New Organisms Act 1996

Name of substance: Non-professional use chlorothalonil formulations

Application number: APP202349

Applicant: Chief Executive, Environmental Protection Authority

Substances for reassessment HSNO Approval number Suspension concentrate containing 500 g/L chlorothalonil (Substance B) HSR000480

Suspension concentrate containing 102 g/L chlorothalonil and 125 g/L HSR000147 thiophanate methyl

Suspension concentrate containing 62.5 g/L chlorothalonil, 9.6 g/L tau- HSR000586 fluvalinate and 62.5 g/L thiophanate methyl

Suspension concentrate containing 250 g/L chlorothalonil and 250 g/L HSR000618 thiophanate methyl

Tui Disease Eliminator (ready to use) HSR100872

www.epa.govt.nz Application for reassessment of home-use chlorothalonil formulations (APP202349) 2

Applicant’s details

Name: Dr. Allan Freeth, Chief Executive

Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140

Phone: 04 474 5403

Fax: 04 914 0433

Email: [email protected]

Applicant’s contact person

Name: Asela Atapattu

Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140

Phone: 04 474 5463

Fax: 04 914 0433

Email: [email protected]

Signature of Applicant

25.10.2016

Dr. Allan Freeth Date Chief Executive Environmental Protection Authority

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 3

Executive Summary

Background Chlorothalonil is a broad spectrum, non-systemic pesticide commonly used as a fungicide to control fungal foliar diseases in vegetables, turf and ornamental crops. It is used in commercial agriculture as well as golf courses and home gardens. Chlorothalonil is also used as a wood protectant and as a biocide in antifouling paints.

The Environmental Protection Authority (EPA) completed a group reassessment of antifouling paints in 2013, which included paints containing chlorothalonil. During this reassessment (APP201051) the classifications of chlorothalonil were reviewed and a number of changes were identified. This led to grounds being established to reassess the classification of the other chlorothalonil containing substances that are approved under HSNO.

It was originally intended that these classification changes would be addressed through the EPA’s Yearly Chemical Review. However, before the Chemical Review was completed the EPA received an application for a home-garden fungicide containing chlorothalonil (APP202057). The assessment of this application identified that there were likely be unacceptable human health risks from the use of this substance, and that these risks could not be mitigated through the application of controls. This application was therefore declined by a Decision Making Committee of the EPA.

Based on this decision the Grounds were established to reassess the five existing chlorothalonil-containing formulations that are used as home-garden fungicides, and these substances were withdrawn from the Yearly Chemical Review. The Grounds were established on the basis of the new information relating to the risks from non-professional use of chlorothalonil containing substances in the home garden, and this is the focus of the present reassessment.

It should be noted that one of the substances included in this reassessment is also used in a professional setting. However, as the Grounds for reassessment were only established for risk from home-use the risks from professional use have not been assessed in this application.

Regulatory reviews of chlorothalonil in the US, Canada and the European Union have identified concerns regarding acute and chronic health effects on people which have resulted in the prohibition of certain uses of chlorothalonil (including non-professional use) and/or the introduction of stringent risk mitigation measures for professional use.

This document contains the staff’s review of the effects of the five chlorothalonil-containing formulations used as home use plant protection fungicides. The application has been prepared by the staff of the EPA on behalf of the Chief Executive, who has initiated this reassessment. It includes risk assessments and preliminary proposals for the affected substances based on the results of those assessments and the information currently available.

It is important to note that the proposals of the staff may or may not be supported by the decision- making committee for this application. The decision-making committee can choose to accept, reject

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 4

or modify the recommendations. For this reason the EPA encourages submissions on the proposals, particularly to provide information to address the uncertainties, assumptions or data gaps identified throughout this document.

Risk assessment The EPA staff have completed a risk assessment and determined that exposure to chlorothalonil as a consequence of non-professional use in New Zealand is likely to result in unacceptable levels of risk to people (operators and bystanders (e.g. children)). The hazard classifications of the substances (all are classified as suspected carcinogens while several are classified as acutely toxic by inhalation, corrosive to the eye and/or as suspected mutagens) also give rise to concern.

Human health risk assessment The risks to human health are highest for the exposure of a toddler (bystander) entering an area where chlorothalonil has been applied. Estimated exposures of up to 100 times higher than acceptable levels have been identified.

Estimated exposures to operators (i.e. people mixing, loading and applying the substance) are greater than the acceptable level for all products. The assessment indicates that the use of personal protective equipment (PPE) is necessary to reduce exposure to an acceptable level. However, EPA staff do not consider it is appropriate to assume that home users will either wear the correct PPE or use and maintain it properly (i.e. wash/store it appropriately and replace it when necessary).

Risks to re-entry ‘workers’1 for all use scenarios are also not acceptable.

Environmental risk assessment Due to the proposed use pattern of the products, environmental exposure may potentially occur. However, exposure is expected to be very limited based on the proposed use pattern of the product (home garden fungicide) and a quantitative environmental exposure and ecological risk assessment was not performed.

Possible control measures A number of control options have been identified that could effectively mitigate a number of risk areas across the different use patterns, including:

 identification requirements

 restricting or prohibiting certain methods of application

 imposing restrictions on application rates, frequencies, and intervals

 prescribing minimum levels of PPE and RPE to be worn

 use of Restricted Entry Intervals (REIs) to prevent people from re-entering treated areas shortly after application

1 re-entry ‘workers’ – any person entering an area that has recently been treated with a chlorothalonil-based substance to perform tasks that may involve contact with treated crops

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 5

 approved handler requirements (where not already applied).

Residual, unmitigated risks and uncertainties Having considered the potential for additional risk mitigation measures to reduce the potential for harm, EPA staff have identified residual risks.

Residual risks remain for non-professional users of these substances as well as for people undertaking re- entry activities and children present in treated areas. Control measures such as use of PPE and restricted entry intervals are not considered to be practical in the home garden setting.

Preliminary proposals The high toxicity of chlorothalonil means that serious human health effects can develop from even very small exposures to chlorothalonil. Therefore EPA staff do not support the continuation of the current non- professional, home garden uses of chlorothalonil, particularly where the assessment has identified significant residual risks that cannot be clearly mitigated by the application of additional controls.

For these reasons, EPA staff consider it is appropriate to adopt a precautionary approach in making proposals for the reassessment of the approvals for non-professional use chlorothalonil formulations. Accordingly, and on the basis of the current information available, the EPA staff’s recommendations are as follows:

HSNO Substance EPA staff proposal Approval No. Suspension concentrate HSR000480 Revoke approval containing 500 g/L chlorothalonil – disposal of existing stocks within six months of (Substance B) decision Known trade name: Yates Bravo

Suspension concentrate HSR000147 Revoke approval containing 102 g/L chlorothalonil – disposal of existing stocks within six months of and 125 g/L thiophanate methyl decision Known trade name: Yates Greenguard

Suspension concentrate HSR000586 Revoke approval containing 62.5 g/L chlorothalonil, – disposal of existing stocks within six months of 9.6 g/L tau-fluvalinate and 62.5 decision g/L thiophanate methyl Known trade name: Yates Guardall

Suspension concentrate HSR000618 Retain approval, with significant restrictions containing 250 g/L chlorothalonil The substance must not be supplied to any person and 250 g/L thiophanate methyl unless — Known trade names: McGregor’s a) The person provides evidence at the time

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 6

HSNO Substance EPA staff proposal Approval No. Black Spot and Fungus Spray; of supply that the substance is required for use in a workplace2; and Watkins Fungus and Mildew Spray b) In the relevant circumstances it is reasonable to believe that evidence. This substance must only be used or stored in a workplace. Non-professional use to be phased out - disposal of existing stocks within 6 months unless industry can demonstrate additional non-professional use is safe

Tui Disease Eliminator (ready to HSR100872 Revoke approval use) – disposal of existing stocks within six months of Known trade name: Tui Disease decision Eliminator for Fruit and Veges RTU

Information requested Throughout this application form, EPA staff have identified key questions or assumptions that submitters may wish to address. If further information in these areas is provided to the EPA it may be possible to revise aspects of the risk assessments and the proposed restrictions. Any revisions to the staff proposals resulting from information provided during the submission period will be presented in the EPA’s Staff Assessment Report3.

The EPA is requesting information in these key areas:

 Updated compositional information (including impurities and source of active ingredient) for the five chlorothalonil-containing formulations

 New information on application rates, frequencies and intervals, typical application areas and time spent by an operator applying the substance

 Any studies on dermal absorption data for the spray, the concentrate, or the active ingredient. Note that if any new studies are to be conducted these should be performed with human skin in vitro.

 Any studies on dislodgable foliar residues (DFR) for treated crops and foliar half-life of chlorothalonil

 Any studies of operator, re-entry or bystander exposure for persons using chlorothalonil relevant to non-professional use in the home garden

 Any other available higher tier information that may allow refinement of the risk assessment

2 A workplace has the same meaning as the Health and Safety at Work Act 2015 3 A Staff Assessment Report (SAR) will be produced in response to submissions received on the proposals in this document. The SAR will be made available to decision-makers and submitters within 10 working days prior to any public hearing.

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Submissions Submissions are invited on the appropriateness and workability of the EPA’s proposals to amend the approvals for chlorothalonil and its formulations.

Shaded boxes have been used throughout the Assessment Section of the application to indicate where there are questions or assumptions which submitters may wish to address. We consider that information provided on these topics may allow us to refine our assessment, and amend the regulatory proposals.

Electronic submissions are encouraged. Please forward your submissions to:

Environmental Protection Authority Private Bag 63002 Wellington 6140 Email: [email protected] Phone: +64 4 916 2426 Fax: +64 4 914 0433

All submissions must be received by 5pm, 16 December 2016.

Any submissions received will be used to inform a decision-making committee that will ultimately decide whether to revoke or retain the approvals for chlorothalonil and its formulations, and whether new controls should be applied to any retained uses.

In accordance with section 54 of the Act, submissions must state the reasons for making the submission, and whether the person making the submission wishes to be heard at a public hearing. The submission may also state any particular decision sought.

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 8

Table of Contents

Signature of Applicant ...... 2

Executive Summary ...... 3 Background ...... 3 Risk assessment ...... 4 Human health risk assessment ...... 4 Environmental risk assessment ...... 4 Possible control measures ...... 4 Residual, unmitigated risks and uncertainties ...... 5 Information requested ...... 6

Table of Contents ...... 8 Chlorothalonil ...... 10 Drivers for reassessment ...... 10 Australia ...... 11 United States ...... 11 Canada ...... 11 Europe ...... 12 New Zealand ...... 12 Purpose of this document ...... 12 Supporting documentation ...... 13 Grounds for reassessment ...... 14 Substances and approvals for reassessment ...... 14 Use patterns evaluated in this reassessment ...... 15 Hazard classification of chlorothalonil-containing substances ...... 16 Changes to default controls ...... 17 Introduction and overview ...... 18 Quantitative risk assessment approach ...... 18 PPE assumptions included in the risk assessment ...... 19 Summary of Human Health and Environmental Risk Assessment ...... 19 Qualitative assessment of human health effects associated with importation, manufacture, transportation and disposal ...... 19 Quantitative assessment of human health risks associated with chlorothalonil use ...... 19 Risk mitigation...... 21 Toolbox of additional controls to mitigate risks ...... 21 Identification of residual risks with additional controls in place ...... 21 Effects on society, communities and culture ...... 24

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 9

Adverse effects on society and communities ...... 24 Relationship of Māori to the environment ...... 25 Benefits assessment ...... 26 Diversity of uses ...... 26 Dependency on chlorothalonil products and potential impacts of withdrawal ...... 27 Weighing up risks and benefits ...... 28 Key areas submitters may wish to address ...... 32 Data gaps, assumptions or uncertainties in the human health risk assessment ...... 32

Appendix A: Timeline of chlorothalonil reassessment activities ...... 33

Appendix B: Use scenarios ...... 34

Appendix C: Qualitative Descriptors for Risk/Benefit Assessment ...... 35

Appendix D: Summary of the quantitative human health risk assessment ...... 39

Appendix E: Alignment of risks with practical control measures ...... 42

Appendix F: Controls applying to Suspension concentrate containing 250 g/litre chlorothalonil and 250 g/litre thiophanate methyl (HSR000618) ...... 43

Appendix G: Science memo ...... 48

Appendix H: References ...... 74

Appendix I: Glossary of terms ...... 75

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 10

Chlorothalonil

1.1. Chlorothalonil is a broad spectrum, non-systemic pesticide commonly used as a fungicide to control fungal foliar diseases in vegetables, turf and ornamental crops. It is used in commercial agriculture as well as golf courses and home gardens. Chlorothalonil is also used as a wood protectant and as a biocide in antifouling paints.

1.2. A number of properties make chlorothalonil an attractive option to control pests across these different use areas. Chlorothalonil is a broad spectrum, contact fungicide with long residual activity. It is considered to be at low risk for the development of resistance by fungal pests due to its mode of action, which involves binding to free amino groups of amino acids in proteins. This provides multi-site inhibition of fungal enzymes critical to the survival/growth of many fungi. As such, it is useful for resistance management purposes in programs with other fungicides that are at higher risk for resistance.

1.3. However, chlorothalonil is highly acutely toxic to humans following inhalation. It is also corrosive to the eyes, and causes contact sensitisation. Chlorothalonil is classified as a suspected carcinogen to humans, based on findings of kidney tumours in male rats and mice and in female rats following administration in long-term toxicity studies.

Drivers for reassessment

1.4. In 2014 EPA staff received an application to import or manufacture a new substance containing chlorothalonil that was intended for use as a fungicide, and to be sold and marketed to home gardeners (EPA application APP202057). For this application EPA staff conducted a quantitative human health risk assessment to estimate the likely exposure of people to chlorothalonil when the substance was used in home garden environments. The risk assessment took into account information about the human toxicity of chlorothalonil and the proposed use pattern of the substance, and used models to predict the exposures to people (users and bystanders).

1.5. The results of the quantitative human health risk assessment identified that there would be risks greater than the level of concern to users and bystanders from the use of the chlorothalonil-containing substance in home garden settings. The application was assessed by a Decision Making Committee (DMC) which concluded that the application should be declined because the positive effects associated with approving the substance would not outweigh the adverse effects.

1.6. The EPA is aware that there are a number of chlorothalonil-containing fungicide products currently marketed and sold to home gardeners in New Zealand. The DMC for APP202057 recommended that there should be a targeted review of these existing substances so that those which also pose an unacceptable human health risk can be excluded from the market.

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 11

1.7. In recent years, regulatory reviews of chlorothalonil in the US, Canada and the European Union concerns have identified concerns relating to acute and chronic human health effects which have resulted in the prohibition of certain uses of chlorothalonil (including non-professional use) and/or the introduction of stringent risk mitigation measures for professional use.. Chlorothalonil is also nominated for review in Australia.

Australia

1.8. Chlorothalonil is included on a list of 19 chemicals, or types of chemical, nominated for review by the Australian Pesticides and Veterinary Medicines Authority (APVMA). A review of chlorothalonil is not scheduled for detailed scoping in 2016 but its priority is to be re-evaluated by December 2016.

1.9. Chlorothalonil is approved for use in Australia on a variety of fruit and vegetable crops, turf, ornamentals, freshly-sawn Pinus spp. timber and in various tree and vine crops. No home garden pesticides containing chlorothalonil are currently registered.

1.10. The key issues identified for a possible APVMA review include: concerns regarding acute and chronic dietary exposures; worker safety issues and environmental concerns relating to a breakdown product of chlorothalonil.

United States

1.11. A human health risk assessment for chlorothalonil was conducted by the US EPA in support of a 1999 Reregistration Eligibility Document (RED).

1.12. Based on the results of the risk assessment risk mitigation measures were set to manage occupational and residential risks. To protect residential handlers of pesticides containing chlorothalonil, and to children exposed after application to home lawns, US registrants agreed that products containing chlorothalonil should be prohibited for use on home lawns.

1.13. In addition, the US EPA restricted professional use on home lawns and turf sites associated with apartment buildings, day-care centres, playgrounds, playfields, recreational park athletic fields, athletic fields located on or next to schools (i.e., elementary, middle and high schools), campgrounds, churches, and theme parks. These restrictions are intended to protect children who may be exposed to chlorothalonil after application.

1.14. Currently chlorothalonil is currently under a further routine registration review by the US EPA (Registration Review, March 2012).

Canada

1.15. In 2011 the Canadian Pest Management Regulatory Agency (PMRA) implemented interim measures similar to the changes introduced in the US (PMRA, 2011). These included additional protective

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 12

equipment to protect workers; a restricted-entry interval to protect workers re-entering treated sites; a statement restricting entry into treated areas for use on turf (including golf greens, tees and fairways); a restriction of the number of applications per floral production cycle on greenhouse cut flowers; and a reduction of maximum application rates on golf courses. Chlorothalonil is not registered in Canada for use around homes or other residential areas such as parks, school grounds and playing fields.

Europe

1.16. Chlorothalonil is registered for use as a plant protection product in Europe (EU, 2006) for professional use. Based on concerns relating to acute and chronic human health effects (corrosive, skin sensitisation and suspected carcinogen) chlorothalonil is not approved for non-professional use.

New Zealand

1.17. The risk assessment performed in APP202057 resulted in the availability of new information on the effects of chlorothalonil home-use formulations that was not available at the time chlorothalonil formulations were transferred into the HSNO legislation in New Zealand.

1.18. Grounds to reassess chlorothalonil home-use formulations under the HSNO Act were formally established by the Environmental Protection Authority (EPA) in June 2015. A timeline of the key events, applications, and engagement processes leading up to this current application for reassessment is provided in Table A1 of Appendix A. Purpose of this document

1.19. The purpose of this application form is to:

 outline the EPA’s preliminary assessment of the risks, costs, and benefits associated with five chlorothalonil-containing substances, and  present the EPA’s proposals to amend, revise or revoke the associated substance approvals.

1.20. The main body of this application summarises the key findings of quantitative risk assessments on chlorothalonil carried out by EPA staff. The detailed documentation of those assessments, including information about the models used, key parameters, and assumptions made by staff, are presented in the supporting appendices attached to this application. Where the staff assessment identified significant levels of risk that are not well managed by the current controls on those substances, EPA staff have considered the potential for new or additional controls to reduce the levels of risk to people arising from chlorothalonil use.

1.21. The benefits (positive effects) of chlorothalonil formulations have also been considered, both in the context of the current status of the substances, and the level of benefit that would be available should the new controls and restrictions, proposed in Section 5 of this application, be adopted.

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1.22. The EPA is now seeking submissions on the proposals outlined in this document.

Supporting documentation

1.23. A number of appendices, referenced in drafting this application, form the basis of the conclusions and proposals put forth by EPA staff. The current document draws attention to the key conclusions of these reports.

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 14

2. Scope of reassessment Grounds for reassessment

2.1. In June 2015, the Environmental Protection Authority (“the EPA”) established grounds to reassess the approvals for non-professional use chlorothalonil-containing formulations, in accordance with section 62 of the Act. In reaching that decision, EPA noted the following:

 That new information came to light during a recent application made to the Authority seeking approval for a new substance containing chlorothalonil (EPA application APP202057, concluded in October 2014).

2.2. After the establishment of grounds to reassess chlorothalonil formulations, EPA staff note the following:

 Four approvals, HSR000480, HSR000147, HSR000586 and HSR100872, are to be reassessed under section 63 of the Act (full reassessment) as these four approvals are only used in home- setting.  One approval, HSR000618, is reassessed under section 63A of the Act (modified reassessment), because under this approval substances are also used by professionals, but Grounds were only established to reassess home-use.  Three approvals contain one or two active ingredient(s) in addition to chlorothalonil, e.g. thiophanate methyl and tau-fluvalinate. These active ingredients have been assessed qualitatively (see Appendix G).  There have been no new HSNO approvals granted for chlorothalonil containing substances for consumer use by the EPA since grounds for reassessment were established.

Substances and approvals for reassessment

2.3. There are five HSNO substance approvals covered by this reassessment. The substances, HSNO approval numbers and known trade names are detailed in Table 1 below.

Table 1. Identification of substances and approvals covered by this application

HSNO Approval Substance description Known trade names number Suspension concentrate containing 500 g/L Yates Bravo HSR000480 chlorothalonil (Substance B)

Suspension concentrate containing 102 g/L Yates Greenguard HSR000147 chlorothalonil and 125 g/L thiophanate methyl

Suspension concentrate containing 62.5 g/L Yates Guardall HSR000586

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 15

HSNO Approval Substance description Known trade names number chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 g/litre thiophanate methyl

Suspension concentrate containing 250 g/L McGregor’s Black Spot and Fungus HSR0006184 chlorothalonil and 250 g/L thiophanate methyl Spray; Watkins Fungus and Mildew Spray

Tui Disease Eliminator (ready to use) Tui Disease Eliminator for Fruit and HSR100872 Veges RTU

Use patterns evaluated in this reassessment

2.4. A number of use patterns were developed by EPA staff in order to evaluate the risks to people from potential exposure to chlorothalonil. The use scenarios were developed based on the recommended label rates and application rates recommended by the New Zealand Novachem Agrichemical Manual. For more detailed information about the specific individual scenarios used in the EPA’s exposure modelling and risk assessment, refer to Appendix D and Appendix G.

4 It is noted that the product “Taratek 5F” also uses the HSR000618 approval code. However, that product is marketed and sold to commercial growers and applicators. The controls that currently apply to HSR000618 require the substance to be under the control of an approved handler, and is subject to tracking requirements under the Hazardous Substances Regulations, when the substance is packaged in quantities > 200 mL. This has the effect of preventing the sale of packaged volumes > 200 mL to the general public. As the Taratek 5F product is packaged in volumes > 200 mL, domestic/home garden use of this substance is not anticipated.

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3. Classifications and revisions Hazard classification of chlorothalonil-containing substances

3.1. The HSNO hazard classifications of chlorothalonil (HSR002825) were reviewed as a part of the previous anti-fouling paint reassessment application, APP201051. Proposed classifications for chlorothalonil (HSR002825) are 6.1B (inhalation), 8.3A, 6.5B, 6.7B, 6.9A (oral), 9.1A, 9.2C, 9.3B.

3.2. Impacts of the changes to the classification of chlorothalonil-containing substances have been reviewed by the EPA staff. The preliminary proposals for changes to the classification of the chlorothalonil-containing substances are listed in Table 2.

Table 2. Summary of the revised HSNO classifications for chlorothalonil-containing formulations (bold text denotes changes to the current classifications)

Approval Substance name Current classification Preliminary classification number Suspension concentrate HSR000480 6.1E (oral), 6.3B, 6.4A, 6.1B (inhalation), 8.3A, 6.5B, containing 500 g/L chlorothalonil 6.5B, 6.7B, 6.9A (All), 6.7B, 6.9A (oral), 9.1A, 9.2C, (Substance B) 9.1A, 9.2B, 9.3B5 9.3B

Suspension concentrate HSR000147 6.1E (oral), 6.3B, 8.3A, 6.1C (inhalation), 8.3A, 6.5B, containing 102 g/L chlorothalonil 6.5B, 6.6B, 6.7B , 6.9A 6.6B, 6.7B, 6.9B (oral), 9.1A, and 125 g/L thiophanate methyl (All), 9.1A, 9.2B, 9.3C6 9.2C, 9.3C

Suspension concentrate HSR000586 6.1D (inhalation), 8.3A, 6.1D (inhalation), 8.3A, 6.5B, containing 62.5 g/L 6.5B, 6.6B, 6.7B, 6.9B 6.6B, 6.7B, 6.9B (oral), 6.9B chlorothalonil, 9.6 g/L tau- (All), 9.1A, 9.2C, 9.3C (dermal), 9.1A, 9.2C, 9.3C fluvalinate and 62.5 g/L thiophanate methyl

Suspension concentrate HSR000618 6.1B (inhalation), 6.4A, 6.1B (inhalation), 6.3B, 8.3A, containing 250 g/L chlorothalonil 6.6B, 6.7B, 6.9A (All), 6.5B, 6.6B, 6.7B, 6.9A (oral), and 250 g/L thiophanate methyl 9.1A, 9.2B, 9.3C7 9.1A, 9.2C, 9.3C

Tui Disease Eliminator (ready to HSR100872 6.5B, 6.7B, 9.1B 6.5B, 6.7B, 9.1C use)

3.3. Staff note that there is a potential that the composition of these substances may have changed since the time they were approved. Therefore the EPA requests that all manufacturers of these

5 Originally classified based on a company Material Safety Data Sheet (MSDS) dated 15/08/03. In 2014, staff requested the provision of an SDS confirming that the classifications are correct for acute inhalation toxicity and skin-& eye corrosion. No information has been received and therefore the proposed revised classification is based on mixture rules. 6 Originally classified based on information supplied by registrant, appears to mainly be based on the company MSDS provided for Yates Bravo. 7 Originally classified based on product data for the product Taratek 5F, which uses the same approval number as McGregor’s Black Spot and Fungus Spray and Watkins Fungus and Mildew Spray. A read across justification is needed to decide if studies provided on Taratek 5F are applicable to these other products..

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 17

substances submit information on their formulations, including details on the source and impurity profile of the active ingredient.

3.4. EPA staff note that although this document proposes to impose significant restrictions and/or revocation of the approvals for some chlorothalonil containing substances, these proposals may change as a result of information provided in submissions. In addition, the decision-making committee for this application may not accept the staff proposals presented in this application for reassessment. For these reasons it is important that up-to-date information on all of the substances is provided so that the hazard classifications can be accurately revised.

3.5. The hazard classification of the chlorothalonil-containing substances will be further reviewed once this information has been received and updated hazard classifications will be published in the EPA’s Staff Assessment Report.

1. Can you supply up-to-date compositional information for a chlorothalonil-containing substance(s)?

This information should be supplied directly to the EPA in commercial confidence. Initial contact can be made through the [email protected] email address. Once initial contact is made you will be provided with additional contact information and instructions on how to provide this information.

Changes to default controls

3.6. The proposed changes to the hazard classifications outlined in Table 2 would result in some changes to the default controls for those substances. The term “default controls” refers to the requirements prescribed under HSNO regulations that are triggered solely by virtue of the hazard classifications of a substance. The anticipated changes to the default controls are summarised in Appendix F.

3.7. The final proposed hazard classifications for the chlorothalonil formulations, and their impact on the default controls, will be published in the EPA’s Staff Assessment Report, after the requested compositional information for these substances has been provided and evaluated. It is always possible that the committee deciding this application will have a different view of the proposed hazard classifications.

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4. Assessment of risks and benefits Introduction and overview

4.1. The HSNO Act requires the assessment of adverse and positive effects. The adverse effects of substances are considered in relation to their toxicity to human health and the environment, and are referred to as risks. A risk is a combination of the magnitude of an adverse effect and the likelihood of that effect occurring. The risks associated with chlorothalonil and its formulations have been assessed for all stages of the substances’ lifecycles: from importation or manufacture, to transportation, storage, use and disposal. Qualitative assessment was undertaken for all lifecycle phases except for use, where quantitative assessment was possible. The risk assessment looked at risks associated with the following:

 human health exposure  environmental exposure  social and cultural considerations, specifically focussing on Māori and their relationship to the environment

4.2. The risks of adverse effects on human health have been assessed by taking into account predicted exposures of applicators or bystanders. Those exposures are compared to maximum levels of exposure that are not expected to result in harmful effects. The data relating to the toxicological effects are based on studies in laboratory animals. Where possible, the toxicity data specific to the substances evaluated are those used by other international regulators. In some instances the EPA has not been able to source key information about factors that may influence exposure to these substances, such as information on penetration through the skin. In these instances the EPA has used default values.

4.3. To assess the risks of adverse effects on the environment a qualitative risk assessment was performed as environmental exposure is expected to be limited when chlorothalonil products are used in a domestic setting.

4.4. Additionally, EPA staff have considered the benefits associated with the availability and use of chlorothalonil-based substances.

Quantitative risk assessment approach

4.5. Individual substances straddle multiple use categories, meaning that the way the substance is used is varied and diverse. Accordingly, an aggregation of the assessments from the different categories is required for each substance to develop an overall picture of the risks associated with use. Furthermore, each use scenario assessed different target groups who may experience difference levels of, and routes to, exposure. The target groups assessed are:

 Human health effects:

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o operators – any person mixing, loading or applying a chlorothalonil-based substance o re-entry ‘workers’ – any person entering an area that has recently been treated with a chlorothalonil-based substance to perform tasks that may involve contact with treated crops o bystanders – any person not involved in the application operation that may involuntarily be exposed to the chlorothalonil-based substance as a consequence of an application

PPE assumptions included in the risk assessment

4.6. In preparing the risk assessment and proposals for this application EPA staff considered that it is not appropriate to assume that non-professionals will wear the correct PPE.

Summary of Human Health and Environmental Risk Assessment

Qualitative assessment of human health effects associated with importation, manufacture, transportation and disposal

4.7. Given the hazards associated with chlorothalonil and its formulations, EPA staff consider that there is potential for adverse effects to occur at any point during the lifecycle of these substances. The staff note that the hazardous properties of these substances have the potential to cause major adverse effects (refer to Appendix C for explanation of the qualitative descriptors used in this assessment).

4.8. However, during the importation, manufacture, transportation, storage and disposal of these substances the staff consider that compliance with the default HSNO controls and other legislative requirements sufficiently mitigate the overall level of risk across these different areas to negligible levels. This assessment takes into account the existing HSNO requirements around packaging, identification, transport and disposal of hazardous substances.

Quantitative assessment of human health risks associated with chlorothalonil use

4.9. EPA staff have used available data and exposure modelling to estimate the exposure of people to chlorothalonil resulting from non-professional use in the home garden. Using this approach EPA staff have determined that many of the current uses of chlorothalonil result in unacceptable risks to people (e.g. operators, re-entry ‘workers’, or bystanders). A high-level summary of the results of the quantitative risk assessments are presented in Appendix D. A full account of these risk assessments, including detailed information about the model parameters, key assumptions, uncertainties, and endpoints are provided in Appendix G.

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Key results of the quantitative human health risk assessment

4.10. The quantitative human health risk assessment determined that the current uses of chlorothalonil present very high levels of risk to operators (those mixing, loading and applying the substances). For example, use on turf and lawns is associated with a risk quotient (RQ8) value for operators of 39 (i.e. 39 times higher than the acceptable operator exposure level [AOEL]).

4.11. Almost all other uses evaluated, including use on ornamentals, vegetables and fruit, indicate high levels of risk to operators based on the current use patterns. A notable exception to this was for the Ready to use (RTU) product (HSR100872) involving only small quantities of chlorothalonil (RQ 1.16).

4.12. Risks to re-entry ‘workers’ for all uses were largely above the acceptable level, between 5 to 119 times higher than the AOEL. A restricted entry interval (REI) without gloves would be 26-70 days; however such a long REI is not considered practical and, furthermore, EPA staff do not consider it is appropriate to assume that an REI can be set in a home use setting.

4.13. The RQ for the exposure of a toddler entering a treated area ranged from more than 39 to 108 times higher than the level of concern (RQ of 1).

4.14. There are a significant number of data gaps which have meant that the staff have had to adopt a precautionary approach in the risk assessment. The risk assessment results could be revised if more information is provided about the factors listed in Appendix D and Appendix G

Key results of the qualitative environmental risk assessment

4.15. As discussed, a quantitative environmental risk assessment was not performed on chlorothalonil products because the environmental exposure in the domestic setting is very low. As a result of the qualitative environmental risk assessment the environmental risks from the use of chlorothalonil product in a domestic setting is low.

3. Can you supply data to demonstrate the levels of chlorothalonil exposure to operators, re-entry ‘workers’, or bystanders?

8 The Risk Quotient (RQ) is a comparison of the estimated exposure to the acceptable operator exposure level (AOEL). RQ values > 1 indicate that exposure is greater than the AOEL.

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Risk mitigation

Toolbox of additional controls to mitigate risks

4.16. EPA staff have considered the potential for reducing risks to people from the use of chlorothalonil by applying additional controls to the substance approvals. The risk mitigation measures that have been considered include the application of controls such as:

 identification requirements

 restricting or prohibiting certain methods of application

 imposing restrictions of application rates, frequencies, and intervals

 prescribing minimum levels of PPE and RPE to be worn

 use of Restricted Entry Intervals (REIs) to prevent people from re-entering treated areas shortly after application

 approved handler requirements (where not already applied)

4.17. It should be noted that the proposed mitigation measures are assessed against the risks for a given receptor. Rationalising the overall risks associated with a given use category is not simply a case of combining all of the mitigation measures, as there may be incompatibility between the required measures for different receptors. For example, risks to operators may be managed by imposing a certain maximum application rate, but this may not be appropriate to manage risks to bystanders. In such situations, the most stringent controls will form the basis of the overall mitigation package for a given use category and substance.

4.18. Details about the specific risk mitigation measures and their potential application across the different use areas are presented in Table E1 in Appendix E.

Identification of residual risks with additional controls in place

4.19. The level of risk from non-professional use has been assessed and, where significant risks have been identified, the application of new risk mitigation measures has been considered. Where these additional risk mitigation measures are considered to be practical and are expected to sufficiently reduce the risks, then the risks are considered to be managed. However, where no practical or sufficiently effective mitigation was identified, significant residual risk remains.

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4.20. A detailed summary of the risks associated with the use of chlorothalonil in domestic-use pesticides, and the evaluation of whether additional risk mitigation measures could sufficiently and practically manage those risks, is presented in Table E1 of Appendix E. This exercise has identified that no risk mitigation measures can reduce risks to negligible levels (Table E1).

4.21. Table 6 highlights the residual risks associated with the use after risk mitigation measures have been considered. Specific details of the risk mitigation measures proposed can be found in Appendix E.

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4.22. This assessment indicates that use in domestic and residential settings results in significant exposures to non-professional operators and other residents which cannot be managed through implementation of additional controls.

Table 6. Residual risks associated with use after practical risk mitigation measures have been considered

Use Human health Environment TOTAL Risk mitigation category Operator Re- Bystander Overall Aquatic Terrestrial Birds Bees cross entry references*

Domestic V. high V. high V. high V. high V. high Note 6,

*The numbered notes refer to the explanatory notes in the final column of Table E1 of Appendix E, and provide details of the risk mitigation measures considered

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Effects on society, communities and culture

Adverse effects on society and communities

4.23. EPA staff have not been able to find any reports of public concern about the use of chlorothalonil in New Zealand. We note that the New Zealand National Poisons Centre has recorded reports for approximately 15 unique exposure incidents (10 adults and 5 children), involving chlorothalonil substances between June 2003 and March 2015. Many of the affected people reported exhibiting acute exposure symptoms, including headaches, dizziness, vomiting, breathing difficulties and sweating. Many of these incidents are noted to have occurred in domestic or public areas (e.g. golf courses) where people have been exposed either during or after the application of a chlorothalonil-containing substance. The routes of exposure primarily relate to inhalation of vapours in treated areas, with incidents of contact or oral exposure also recorded.

4.24. In the USA, California is the only state that requires physicians to report the treatment of illnesses related to pesticide exposure. Between 1982 and 1992, 133 incident case reports involving chlorothalonil were received by the California Pesticide Illness Surveillance Program. In these reports, adverse health effects were attributed to exposure to chlorothalonil or chlorothalonil used in combination with other pesticides. In most cases, the incidents involved mixer/loaders and applicators and were the result of accidents such as splashes or carelessness such as not wearing protective eyewear. The reported symptoms attributed to chlorothalonil were primarily eye irritations and skin rashes. According to the US EPA's Recognition and Management of Pesticide Poisonings (March 1989), chlorothalonil has caused skin irritation and irritation of mucous membranes of the eye and respiratory tract. Dermal sensitization is reportedly rare and no cases of human systemic poisoning have been reported.

4.25. Health Canada has reported 36 incident reports between 2008-2013 for people and domestic animals. The human incidents are mainly minor, like irritation to the eye and respiratory irritation. The incidents reported for animals are more severe (death).

4.26. There is broader social concern regarding use of pesticides in general given the known human health and environmental hazards. The EPA is aware that there is growing general social concern and anxiety about the health risks related to pesticides use in a residential setting. The risks to consumers and bystanders from the current uses of chlorothalonil have been modelled in the EPA staff risk assessment (Appendix G). This assessment confirms that many of the current use patterns present unacceptable risks to consumers and toddlers, and indicates that no risk mitigation measures can reduce risks to negligible levels No adverse effects on society and community that might result from the unavailability of the substances have been identified. However, any information that can be provided on this aspect is welcomed through submissions.

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Relationship of Māori to the environment

4.27. The potential effects to the relationship of Māori to the environment have been assessed in accordance with sections 5(b), 6(d) and 8 of the Act. Under these sections all persons exercising functions, powers and duties under this Act shall: Recognise and provide for the maintenance and enhancement of people and communities to provide for their cultural well- being, and; take into account the relationship of Māori and their culture and traditions with their ancestral lands, water, taonga and the principles of the Treaty of Waitangi (Te Tiriti o Waitangi).

4.28. In consideration of these functions and duties, this section provides an initial evaluation of impacts of chlorothalonil on Māori interests including taha hauora, kaitaiakitanga and Treaty of Waitangi considerations. During the course of this application process the EPA intends to consult iwi / Māori to obtain further information regarding impacts.

Taha hauora

4.29. Taha hauora is the Māori philosophy of health which encompasses the four dimensions of taha tinana (physical), taha hinengaro (thoughts and feelings), taha whanau (family unit), and taha wairua (spiritual). Given the hazards associated with chlorothalonil formulations there is the potential for the substance to adversely affect human well-being when exposed to chlorothalonil.

4.30. Our initial assessment is that chlorothanlonil presents significant potential risk to Māori in terms of adversely affecting taha hauora, including vulnerable groups such as tamariki (children) and kaumātua (the elderly). Chlorothalonil raises concerns around how potential harm to taha hauora may manifest in relation to whānau environments and lifestyle contexts. This substance may potentially affect all four cultural health dimensions of taha hauora.

Kaitiakitanga

4.31. In terms of this application the role of kaitiakitanga can be considered as enabling the protection of resources for the current and future welfare of people and the environment. Hence, kaitiakitanga is the key means by which sustainability is achieved by Māori.

4.32. It is noted that continued availability of chlorothalonil raises concern from a tikanga Māori perspective in relation to manaakitanga, the principle of valuing people, acting with goodwill and beneficial purpose, showing respect, caring for and protecting people and the environment.

4.33. Staff consider that, with appropriate controls in place, the responsible use of chlorothalonil may aid in the protection of resources and be useful tools for Māori when undertaking their role as kaitiaki. However, on balance, the availability of chlorothalonil may not engender an overall net benefit for kaitiakitanga.

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Treaty of Waitangi (Te Tiriti o Waitangi)

4.34. Section 8 of the Act requires the Authority, when considering applications, to take into account the principles of the Treaty of Waitangi. Of particular relevance to this application is the principle of active protection and the obligation to take positive steps to ensure Māori interests are protected.

4.35. Taking into account the principle of active protection requires this application to provide sufficient evidence to show that the use of chlorothalonil and its approved formulations pose no significant risk of adverse effects to native/endemic species and/or other taonga species, ecosystems and traditional Māori values, practices, health and well-being. Having considered the information outlined previously in relation to the adverse effects and benefits, EPA staff consider that this application is consistent with the principle of active protection.

Benefits assessment

4.36. The staff assessment of the benefits associated with use of chlorothalonil products took into account the following information:

 Broad-spectrum activity

 Diversity of uses

 Impacts of potential withdrawal

 Non-professional use

 Society and communities

Broad-spectrum activity

4.37. Chlorothalonil is a broad spectrum, contact, and protectant fungicide with long residual activity. Chlorothalonil is considered to be at low risk for resistance due to its mode of action. Its mode of action involves binding to free amino groups of amino acids in proteins, which provides multi- site inhibition of fungal enzymes critical to the survival/growth of many fungi. However, while resistance management is of critical importance in commercial use of plant protection products it is of limited relevance for home use where resistance is less of an issue.

Diversity of uses

4.38. A key benefit offered by chlorothalonil products is the diversity of uses including for flowering plants, fruit, vegetables and lawns.

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4.39. However, several alternatives are available for use in a home-setting. Several fungicides with lower hazards are available, including horticultural oils, sulfur, and the biological fungicide (Bacillus Subtilis).

Dependency on chlorothalonil products and potential impacts of withdrawal

4.40. No information has been provided by industry to date which indicates that chlorothalonil is an important and significant tool; or, should chlorothalonil products not be available, there would be significant impacts on their potential for market-access issues to arise.

4.41. The staff note that determining the reliance on chlorothalonil, and estimating the impacts associated with unavailability of chlorothalonil, is difficult and conditional on numerous factors (such as consumer use). The EPA do not have any further details of how often chlorothalonil is used.

Non-professional use

4.42. While there are properties of chlorothalonil products that are considered to be beneficial in terms of practicality and broad spectrum control, limited market usage suggests that there is no particular dependency on chlorothalonil and that alternative pest control options are being used.

4.43. The economic benefits associated with non-professional use of chlorothalonil are not known. The infrequent use would indicate that the benefits directly attributable to chlorothalonil usage are low, and not likely to impact on the overall benefit offered by chlorothalonil generally. Chlorothalonil is not available for home-gardeners in USA, Canada and EU. Recently consumer products containing chlorothalonil were withdrawn from the Australian market. This suggests the economic benefits of non-professional use of chlorothalonil overseas is low.

4.44. The EPA staff have qualitatively assessed9 the level of benefits and consider that the magnitude of benefit offered by chlorothalonil is, at most, minimal, considering the specific properties and the availability of alternative substances. The likelihood of this level of benefit being offered in the pest management, the domestic sector is unlikely. Accordingly, the level of benefit to the non-horticultural sector is considered to be negligible.

Benefits to society and communities

4.45. Gardening is a popular pastime in New Zealand and it has been suggested that the ability to successfully raise crops and flowers is considered an important contributing factor to the health and well-being of participants. A similar argument could be made for uses on sports turf including golf courses, bowling greens and playing fields. However, in the absence of further data the EPA is unable to quantify these benefits.

9 For explanation of the qualitative descriptors, refer to Appendix C.

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4.46. Benefits to society and our community from the continued availability and non-plant protection use of chlorothalonil, based on its properties as an effective pesticide, are closely allied to public health benefits.

4.47. The staff consider that the level of indirect benefit to public health through use of chlorothalonil is estimated to be minimal, given the low-level and localised usage for public health purposes. This level of benefit is likely to occur if chlorothalonil is used, resulting in a low level of positive effect.

4.48. No potentially significant benefits or positive effects to society and communities as a result of the unavailability of the substances have been identified. The staff consider that chlorothalonil use for home-use purposes are not critical, as it is likely that there are sufficient alternative substances available, and accordingly, these benefits will largely be provided by alternative pesticides.

The EPA requests further information on the consumer use, the consumer use behavior of pesticides, the alternatives for various pests.

Weighing up risks and benefits

4.49. The risks and benefits associated with each use category have been evaluated, and weighed up against each other. This is summarised in Table 7.

4.50. Based on existing information, EPA staff consider that consumer uses of chlorothalonil should be prohibited unless further information can be provided to demonstrate that those risks can be managed.

Table 7. Weighing up of the risks and benefits

Level of Level of Comments / Summary Use category Proposal Residual Risks Benefits of mitigation measures

RISKS > BENEFITS No practical or effective mitigation measures can The risks are not outweighed by be implemented to Non-professional use Very high Negligible the benefits and chlorothalonil use sufficiently reduce the should be prohibited for this use risks presented to this category. sector

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5. Proposals

5.1. In making these proposals, the staff have considered the risks and benefits offered by each substance. Additionally, the staff have taken a precautionary approach where significant uncertainties in the level of exposure to people have been identified in the risk assessments. The staff consider this precautionary approach is in alignment with the intent and purpose of the HSNO Act10 to protect the health of people and communities from the effects of hazardous substances.

5.2. Four of the five approvals included in the present reassessment (HSR000480, HSR000147, HSR000586 and HSR100872) are only used in the home garden. EPA staff are proposing that the approvals for these substances are declined. Staff are proposing that if the DMC agrees that these substance approvals should be revoked, there should be a requirement for existing stocks to be disposed of within six months following the issuing of the decision. This is consistent with the decision taken for the EPA’s recent reassessment of dichlorvos (application no. APP202097).

5.3. The remaining approval (HSR000618) covers both substances used in the home garden and in a professional setting. EPA staff propose that for this substance approval additional controls are applied to prevent use by non-professionals. As Grounds for reassessment were only established for non-professional use, EPA Staff have not assessed the risks associated with professional use of this substance. Staff acknowledge that based on the outcome of an exposure assessment of the professional use scenario additional controls might be needed for this substance. However, the professional use scenario is out of the scope of the present reassessment.

5.4. Taking the proposals for each of the use categories for each of the chlorothalonil substances, the staff propose the following decisions as outlined in Table 8 below.

Table 8. Proposals of EPA staff to amend or revoke the HSNO approvals for chlorothalonil formulations

Proposed decision Approval number Substance name Product name

Revoke approval – Suspension concentrate disposal of existing HSR000480 containing 500 g/litre Yates Bravo stocks within six chlorothalonil (Substance B) months of decision

10 Clause 4 of the Hazardous Substances and New Organisms Act 1996 states the following: 4 Purpose of Act The purpose of this Act is to protect the environment, and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms.

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Proposed decision Approval number Substance name Product name

Revoke approval - Suspension concentrate disposal of existing HSR000147 containing 102 g/L chlorothalonil Yates Greenguard stocks within six and 125 g/L thiophanate methyl months of decision

Revoke approval - Suspension concentrate disposal of existing containing 62.5 g/L chlorothalonil, HSR000586 Yates Guardall stocks within six 9.6 g/L tau-fluvalinate and 62.5 months of decision g/L thiophanate methyl

Retain approval, with significant restrictions (Appendix F) McGregor’s Black Spot and Non-professional use Suspension concentrate 11 Fungus Spray; to be phased out HSR000618 containing 250 g/L chlorothalonil within 6 months and 250 g/L thiophanate methyl Watkins Fungus and Mildew unless industry can Spray demonstrate non- professional use is safe

Revoke approval - disposal of existing Tui Disease Eliminator (ready to Tui Disease Eliminator for Fruit HSR100872 stocks within six use) and Veges RTU months of decision

5.5. The staff would like to reiterate that the proposals may change if additional information can be provided to refine the risk assessment and/or demonstrate that the risks can be adequately and practically managed.

5.6. However, due to the magnitude of the risks identified, and the nature of the use patterns, the staff consider that no amount of refinement of the risk assessment is unlikely to be able to sufficiently reduce the risks identified to human health associated with chlorothalonil use in domestic or residential settings.

5.7. The staff consider that the classifications outlined in Table 10 should be conferred on the approval proposed to be retained, and the default controls on the substance be adjusted accordingly to reflect these changes. For the approval (HSR000618) that is proposed to be retained, the additional controls are detailed in Appendix F.

5.8. The staff consider that:

11 - disposal of existing stocks within six months of decision

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 the disposal of existing stocks of the domestic use product approvals should occur within six months, given the high levels of risk presented by these substances to operators, re- entry ‘workers’ and bystanders (toddlers);  the revised classifications and controls for the remaining approval, HSR00618 should come into effect as soon as possible. However, in terms of practicality, a transitional period of 12 months should be sufficient to allow existing stocks to either be used or recovered for relabelling.

The EPA is now seeking submissions on the assessment and the proposals outlined in this document.

Electronic submissions are encouraged. Please forward your submissions to:

Environmental Protection Authority

Private Bag 63002

Wellington 6140

Email: [email protected]

Phone: +64 4 916 2426 Fax: +64 4 914 0433

All submissions must be received by 5pm, 16 December 2016.

Any submissions received will be used to inform an independent decision-making committee that will ultimately decide whether to approve the application.

In accordance with section 54 of the Act, submissions must state the reasons for making the submission, and whether the person making the submission wishes to be heard at a public hearing. The submission may also state any particular decision sought.

Submissions that contribute further information where knowledge gaps have been identified are particularly encouraged. Further information provided in these areas may allow for further refinement of the risk assessments and resulting proposals. A summary of these significant areas of uncertainty, data gaps, or where key assumptions have been made, are outlined again below to assist potential submitters.

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Key areas submitters may wish to address

Data gaps, assumptions or uncertainties in the human health risk assessment

Uncertainty in the human health risk assessment 1. The HSNO Act requires staff and decision makers to take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those adverse effects. Risk assessments carried out by staff always have a degree of uncertainty associated with them. Typically staff account for this uncertainty by quantitatively adopting a conservative approach in the risk assessment, for example, use of uncertainty factors or default values to compensate for the lack of information. Provision of further information relating to some of these key areas could potentially enable the risk assessment to be refined.

Uncertainty about exposure of operators, workers and bystanders 2. For plant protection uses of chlorothalonil EPA staff have used models and datasets which are typically used for consumer products. Exposure studies relevant to home garden use of chlorothalonil substances could support a refinement of the risk assessment.

Assumptions about exposure following re-entry into a treated area 3. The EPA has made assumptions about how quickly chlorothalonil residues on plants would degrade. These assumptions are based on default values. The concentration of chlorothalonil could be affected by environmental conditions such as temperature and humidity. Provision of information on dislodgeable foliar residues or the foliar half-life of chlorothalonil could potentially enable the risk assessment to be refined.

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Appendix A: Timeline of chlorothalonil reassessment activities

Table A1. An overview of key events, applications, and engagement processes leading up to this application for reassessment of chlorothalonil formulations for consumer use.

Key steps Context Key dates Transfer into HSNO Chlorothalonil-containing formulations that had 28 June 2006 legislation been approved under previous legislation were transferred into the HSNO Act legislation.

EPA application Sixty approvals for antifouling paint formulations Decided, 26 June 2013 (APP201051) manufactured in New Zealand or imported were reassessed, including paints containing chlorothalonil. The HSNO classifications for chlorothalonil (HSR002825) were assessed and several changes were identified.

EPA application An application to import or manufacture a new Decided 21 August 2014 (APP202057) chlorothalonil-containing substance for use by home gardeners was declined by the Authority.

EPA application Chlorothalonil (HSR002825) and substances Decided 4 February 2015 containing chlorothalonil were included in grounds (APP201983) under section 62 of the Act to reassess a number of hazardous substances approvals grouped as the Chemical Review 2012-2014. Grounds for reassessment were based on the new information relating to the hazard classification of chlorothalonil identified in APP201051.

EPA application Grounds for Reassessment of non-professional Decided 16 June 2015 use of chlorothalonil fungicides were established (APP202348) in accordance with s62 of the Act.

Engagement and Consultation with representatives from industry, June-July 2015 consultation (1) manufacturers and suppliers of chlorothalonil formulations, and local and central government.

EPA application Current application for reassessment of home-use Open for submissions 4 (APP202349) chlorothalonil formulations. November 2016 (This document) Submissions related to chlorothalonil from previous application (APP202348) have been considered in the preparation of the current application.

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Appendix B: Use scenarios

The table B1 provides an overview of the use scenarios evaluated by EPA staff in preparing this application. Quantitative risk assessments based on these use scenarios are presented in Appendix G (Human Health Risk Assessment).

Table B1. Non-professional uses of chlorothalonil formulations that have been assessed by EPA staff

Home-use use scenarios used in the risk assessment

Use pattern Formulation Application Source of Method Area treated type rate information Application rate recommended by the Spraying New Zealand ornamentals, Novachem EC Backpack 1500 g a.i./ha 100 m2 vegetables, Agrichemical Manual fruit Treated area is default value for non- professional use

Label rate Spraying turf, EC Backpack 4080 g ai./ha 100 m2 Treated area is lawns, cotula default value for non- professional use

Application rate recommended by the New Zealand Spraying Manual Novachem vegetables, RTU spray 1500 g a.i./ha 100 m3 spraying Agrichemical Manual fruit Treated area is default value for non- professional use

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Appendix C: Qualitative Descriptors for Risk/Benefit Assessment

Qualitative descriptors are indicative only and they are primarily intended to be used to rank risks and benefits for the purposes of balancing risks and costs against benefits, and so that risks can be prioritised for management. The ‘descriptor’ words should not be seen in any absolute senses – they are simply a means of differentiating levels of significance. Assessing risks, costs and benefits qualitatively

This section describes how EPA staff and the Authority address the qualitative assessment of risks, costs and benefits. Risks and benefits are assessed by estimating the magnitude and nature of the possible effects and the likelihood of their occurrence. For each effect, the combination of these two components determines the level of the risk associated with that effect, which is a two dimensional concept. Because of lack of data, risks are often presented as singular results. In reality, they are better represented by ‘families’ of data which link probability with different levels of outcome (magnitude).

The magnitude of effect is described in terms of the element that might be affected. The qualitative descriptors for magnitude of effect are surrogate measures that should be used to gauge the end effect or the ‘what if’ element. Tables C1 and C2 contain generic descriptors for magnitude of adverse and beneficial effect. These descriptors are examples only, and their generic nature means that it may be difficult to use them in some particular circumstances. They are included here to illustrate how qualitative tables may be used to represent levels of adverse and beneficial effect.

Table C1. Magnitude of adverse effect (risks and costs)

Descriptor Examples of descriptions - Adverse

Mild reversible short term adverse health effects to individuals in highly localised area Highly localised and contained environmental impact, affecting a few (less than ten) individuals members of communities of flora or fauna, no discernible ecosystem impact Minimal Local/regional short-term adverse economic effects on small organisations (businesses, individuals), temporary job losses No social disruption

Mild reversible short term adverse health effects to identified and isolated groups Localised and contained reversible environmental impact, some local plant or animal communities temporarily damaged, no discernible ecosystem impact or species damage Minor Regional adverse economic effects on small organisations (businesses, individuals) lasting less than six months, temporary job losses Potential social disruption (community placed on alert)

Minor irreversible health effects to individuals and/or reversible medium term adverse health effects Moderate to larger (but surrounding) community (requiring hospitalisation)

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Descriptor Examples of descriptions - Adverse

Measurable long term damage to local plant and animal communities, but no obvious spread beyond defined boundaries, medium term individual ecosystem damage, no species damage Medium term (one to five years) regional adverse economic effects with some national implications, medium term job losses Some social disruption (e.g. people delayed)

Significant irreversible adverse health effects affecting individuals and requiring hospitalisation and/or reversible adverse health effects reaching beyond the immediate community

Major Long term/irreversible damage to localised ecosystem but no species loss Measurable adverse effect on GDP, some long term (more than five years) job losses Social disruption to surrounding community, including some evacuations

Significant irreversible adverse health effects reaching beyond the immediate community and/or deaths

Massive Extensive irreversible ecosystem damage, including species loss Significant on-going adverse effect on GDP, long term job losses on a national basis Major social disruption with entire surrounding area evacuated and impacts on wider community

Table C2. Magnitude of beneficial effect (benefits)

Descriptor Examples of descriptions - Beneficial

Mild short term positive health effects to individuals in highly localised area Highly localised and contained environmental impact, affecting a few (less than ten) individuals members of communities of flora or fauna, no discernible ecosystem impact Minimal Local/regional short-term beneficial economic effects on small organisations (businesses, individuals), temporary job creation No social effect

Mild short term beneficial health effects to identified and isolated groups Localised and contained beneficial environmental impact, no discernible ecosystem impact Minor Regional beneficial economic effects on small organisations (businesses, individuals) lasting less than six months, temporary job creation Minor localised community benefit

Minor health benefits to individuals and/or medium term health impacts on larger (but surrounding) community and health status groups Measurable benefit to localised plant and animal communities expected to pertain to medium term Moderate Medium term (one to five years) regional beneficial economic effects with some national implications, medium term job creation Local community and some individuals beyond immediate community receive social benefit.

Major Significant beneficial health effects to localised community and specific groups in wider community

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Descriptor Examples of descriptions - Beneficial

Long term benefit to localised ecosystem(s) Measurable beneficial effect on GDP, some long term (more than five years) job creation Substantial social benefit to surrounding community, and individuals in wider community.

Significant long term beneficial health effects to the wider community Long term, wide spread benefits to species and/or ecosystems Massive Significant on-going effect beneficial on GDP, long term job creation on a national basis Major social benefit affecting wider community

The likelihood applies to the composite likelihood of the end effect, and not either to the initiating event, or any one of the intermediary events. It includes:

- the concept of an initiating event (triggering the hazard), and

- the exposure pathway that links the source (hazard) and the area of impact (public health, environment, economy, or community).

Thus, the likelihood is not the likelihood of an organism escaping, or the frequency of accidents for trucks containing hazardous substances, but the likelihood of the specified adverse effect12 resulting from that initiating event. It will be a combination of the likelihood of the initiating event and several intermediary likelihoods13. The best way to determine the likelihood is to specify and analyse the complete pathway from source to impact.

Likelihood may be expressed as a frequency or a probability. While frequency is often expressed as a number of events within a given time period, it may also be expressed as the number of events per head of (exposed) population. As a probability, the likelihood is dimensionless and refers to the number of events of interest divided by the total number of events (range 0-1).

Table C3. Likelihood

Descriptor Description

Highly improbable Almost certainly not occurring but cannot be totally ruled out

Very unlikely Considered only to occur in very unusual circumstances

Unlikely (occasional) Could occur, but is not expected to occur under normal operating conditions

Likely A good chance that it may occur under normal operating conditions

12 The specified effect refers to scenarios established in order to establish the representative risk, and may be as specific as x people suffering adverse health effects, or y% of a bird population being adversely affected. The risks included in the analysis may be those related to a single scenario, or may be defined as a combination of several scenarios. 13 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.

February 2016 38

Application for reassessment of home-use chlorothalonil formulations (APP202349)

Descriptor Description

Highly likely Almost certain, or expected to occur if all conditions met

Using the magnitude and likelihood tables a matrix representing a level of risk/benefit can be constructed.

In the example shown in Table C4, four levels of risk/benefit are allocated: A (negligible), B (low), C (medium), and D (high). These terms have been used to avoid confusion with the descriptions used for likelihood and magnitude, and to emphasise that the matrix is a tool to help decide which risks/benefits require further analysis to determine their significance in the decision making process.

For negative effects, the levels are used to show how risks can be reduced by the application of additional controls. Where the table is used for positive effects it may also be possible for controls to be applied to ensure that a particular level of benefit is achieved, but this is not a common approach. The purpose of developing the tables for both risk and benefit is so that the risks and benefits can be compared.

Table C4. Level of risk

Magnitude of effect Likelihood Minimal Minor Moderate Major Massive

Highly improbable A A A B B

Very unlikely A A B B C

Unlikely A B B C C

Likely B B C C D

Highly likely B C C D D

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Application for reassessment of home-use chlorothalonil formulations (APP202349)

Appendix D: Summary of the quantitative human health risk assessment

Tables D1-D10 of this appendix provide a high-level summary of the results from the EPA staff human health risk assessment of chlorothalonil uses in New Zealand. This summary is derived from the results presented in Appendix G, and readers are directed to this appendix for details of the methodology, specific use scenarios modelled, key assumptions, and further results.

The level of risk is presented in the form of Risk Quotients (RQs). The RQs compare a person’s estimated exposure concentration with a concentration of toxicological concern. Values >1 are considered to be of concern.

The levels of risk summarised in Table D1 have been colour coded for ease of viewing according to the following colour scheme:

RQ = 0-1

The green cells draw attention to areas where levels of exposure were determined to be below the level of concern, i.e. below the Acceptable Operator Exposure Level (AOEL).

RQ = 1-3

Orange cells indicate areas where operators, re-entry workers or bystanders are expected to be exposed to up to 3 times the AOEL. These risks are considered by EPA staff to be unacceptable under current conditions but could potentially be mitigated to acceptable levels by applying new controls aimed to reduce levels of exposure.

RQ >3

The red-highlighted cells draw attention to areas of high risk. The RQ values equate indicate how much higher the exposure to chlorothalonil is above the AOEL. For example RQ = 40 corresponds to an exposure 40 times higher than the AOEL.

ND

Black cells with the text “ND” draw attention to areas where there is insufficient data available to conduct a quantitative risk assessment. na = not applicable; – not evaluated

Table D1. Operator, re-entry and bystander risk assessment for domestic applications of chlorothalonil

February 2016 Total Total operator Bystander Concentration Application rate Total re-entry systemic Application for reassessment of home-use chlorothalonil formulations (APP202349) 40 (toddler) RQ RQ systemic RQ bystander Approval Operation (g (g exposure (mg/kg bw/0.5 exposure Exposure Operator Re-entry (toddler) chlorothalonil/L chlorothalonil/ha) hrs) (mg/kg bw/day) (µg/kg

bw/day)

Vegetables - reach/pick: Vegetables - reach/pick: 6.50 0.06 Fruits (from trees) - Spraying Fruits (from trees) - search/reach/pick: 11.69 HSR000480 ornamentals, 500 1500 0.222 search/reach/pick: 0.11 425.77 24.62 47.31 Berries - reach/pick: 7.79 vegetables, fruit Berries - reach/pick: 0.07 Ornamentals - Ornamentals - Cut/sort/bundle/carry: 12.99 Cut/sort/bundle/carry: 0.12

Vegetables - reach/pick: Vegetables - reach/pick: 5.47 0.05 Fruits (from trees) - Spraying Fruits (from trees) - search/reach/pick: 9.84 HSR000147 ornamentals, 102 1500 0.103 search/reach/pick: 0.09 358.39 11.45 39.82 Berries - reach/pick: 6.56 vegetables, fruit Berries - reach/pick: 0.06 Ornamentals - Ornamentals - Cut/sort/bundle/carry: 10.93 Cut/sort/bundle/carry: 0.10

Turf irrigation/mowing: 0.05 Turf irrigation/mowing: 5.95 Spraying turf, HSR000147 102 4080 0.351 Turf hand 974.83 39.01 Turf hand 108.31 lawns, cotula weeding/transplanting: weeding/transplanting: 118.96 1.07

Vegetables - reach/pick: Vegetables - reach/pick: 6.50 0.06 Spraying Fruits (from trees) - Fruits (from trees) - HSR000586 ornamentals, 62.5 1500 0.088 425.77 9.83 search/reach/pick: 11.69 47.31 search/reach/pick: 0.11 vegetables, fruit Ornamentals - Ornamentals - Cut/sort/bundle/carry: 12.99 Cut/sort/bundle/carry: 0.12

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 41

Vegetables - reach/pick: 0.05 Vegetables - reach/pick: 5.47 Spraying Fruits (from trees) - Fruits (from trees) - HSR000618 ornamentals, 250 1500 0.151 search/reach/pick: 0.09 358.39 16.81 search/reach/pick: 9.84 39.82 vegetables, fruit Ornamentals - Ornamentals - Cut/sort/bundle/carry: Cut/sort/bundle/carry: 10.93 0.010

Vegetables - reach/pick: Vegetables - reach/pick: 5.47 Spraying RTU 0.05 HSR100872 1.5 1500 0.010 358.39 1.16 Fruits (from trees) - 39.82 vegetables, fruit Fruits (from trees) - search/reach/pick: 9.84 search/reach/pick: 0.09

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 42

Appendix E: Alignment of risks with practical control measures

Table E1. Summary of the key human health risk areas associated with the different use scenarios.

Use category / Risk receptor Description of key risks Practical mitigation measures substance

Non-professional Operator When applied by non-professional users, the substances are considered to present high No practical controls possible risks to operators. A contributing factor is that non-professionals are not considered to

have access to the appropriate level of PPE and RPE that would be required to reduce exposure risks. Furthermore, it is assumed that non-professional users do not have sufficient expertise to use and maintain their PPE and RPE appropriately. Accordingly, access to these substance should be restricted to professionals.

Re-entry, bystander / In domestic settings, nobody should enter a treated area until the concentrations of No practical controls possible resident chlorothalonil have dropped sufficiently, to levels that no longer present exposure risks. In domestic settings, there are practicality concerns regarding implementation of measures such as REIs.

Furthermore, domestic settings are more likely to have more susceptible people present, such as toddlers, who may suffer adverse effects as a consequence of exposure to lower levels of chlorothalonil.

Aquatic environment Risks are not expected to arise during indoor application under normal circumstances. - Furthermore, the magnitude of adverse effect is expected to be minimal to minor at Terrestrial environment worst, and very unlikely, giving rise to a negligible level of risk. No residual risks are Terrestrial vertebrates identified with existing controls in place. (birds)

Terrestrial invertebrates (bees)

February 2016 Application for reassessment of home-use chlorothalonil formulations (APP202349) 43

Appendix F: Controls applying to Suspension concentrate containing 250 g/litre chlorothalonil and 250 g/litre thiophanate methyl (HSR000618)

Proposed amendments to existing suite of controls for this substance are highlighted in Table F1.

Table F1: Controls for HSR000618

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

Code Regulation Description (including variations and explanatory notes)

T1 Regs 11 – 27 Limiting exposure to toxic substances through the setting of TEL, ADE and PDE values No TEL values are set for any component of this substance at this time.

T2 Regs 29, 30 Controlling exposure in places of work through the setting of WESs. Variation: The Authority adopts as Workplace Exposure Standards for this substance, and each component of this substance, any applicable value or values specified in the document described in the 7th Edition of “Workplace Exposure Standards and Biological Exposure Indices”.1415

T3 5(1), 6 Requirements for keeping records of use

T4 Reg 7 Requirements for equipment used to handle substances

T5 Reg 8 Requirements for protective clothing and equipment

T6 9 Approved handler/security requirements for certain toxic substances Variation: The following regulation is inserted immediately after regulation 9:

9A Exception to approved handler requirement for transportation of packaged pesticides

(1) Regulation 9 is deemed to be complied with if: (a) when this substance is being transported on land— (i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in accordance with the approved safety system for the time being approved under section 6D of the Transport Services Licensing Act 1989; and (ii) other than by rail, the person who drives, loads, and unloads the vehicle that is transporting the substance has a current dangerous goods endorsement on his or her driver licence; and (iii) in all cases, Land Transport Rule: Dangerous Goods 1999 (Rule 45001) is complied with; or (b) when this substance is being transported by sea, one of the following is

14 http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and- biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdf 15 Any reference to this document in these controls refers to any subsequent version approved or endorsed by the EPA

Application for reassessment of home-use chlorothalonil formulations (APP202349) 44

Code Regulation Description (including variations and explanatory notes) complied with: (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A): (ii) International Maritime Dangerous Goods Code; or (c) when this substance being transported by air, Part 92 of the Civil Aviation Rules is complied with. (2) Subclause (1)(a)— (a) does not apply to a tank wagon or a transportable container to which the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 applies; but (b) despite paragraph (a), does apply to an intermediate bulk container that complies with chapter 6.5 of the UN Model Regulations. (3) Subclause (1)(c)— (a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an aerodrome; but (b) does not apply to— (i) the handling of this substance in any place that is not within an aerodrome; or (ii) the loading and managing of this substance for the purpose of aerial spraying or dropping. (4) In this regulation, UN Model Regulations means the 19th revised edition of the Recommendation on the transport of Dangerous Goods Model Regulations, published in 2015 by the United Nations. The following regulation is inserted immediately after regulation 9A:

9B Exception to approved handler requirement for aerial application of certain substances Regulation 9 is deemed to be complied with if, in the case of the aerial application of a hazardous substance, the person who carries out the application has a current pilot chemical rating in accordance with Part 61 of the Civil Aviation Rules.

T7 Reg 10 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles

E1 Regs 32 – 45 Limiting exposure to ecotoxic substances through the setting of EELs Variation: No EEL values are set at this time and the default EELs are deleted

E2 46 – 48 Restrictions on use of substances in application areas

E5 Regs 5(2), 6 Requirements for keeping records of use

E6 Reg 7 Requirements for equipment used to handle substances

E7 Reg 9 Approved handler/security requirements for certain ecotoxic substances Variation: See control T6

Hazardous Substances (Identification) Regulations 2001

Code Regulation Description

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Code Regulation Description

I1 Regs 6, 7, 32 Identification requirements, duties of persons in charge, accessibility, comprehensibility, – 35, 36(1) – clarity and durability (7)

I2 8 Priority identifiers for corrosive substances

I3 Reg 9 Priority identifiers for ecotoxic substances

I8 14 Priority identifiers for toxic substances

I9 Reg 18 Secondary identifiers for all hazardous substances

I10 19 Secondary identifiers for corrosive substances

I11 Reg 20 Secondary identifiers for ecotoxic substances

I16 Reg 25 Secondary identifiers for toxic substances

I17 Reg 26 Use of generic names

I18 Reg 27 Requirements for using concentration ranges

I19 Regs 29 – 31 Additional information requirements, including situations where substances are in multiple packaging

I20 Reg 36(8) Durability of information for class 6.1 substances

I21 Regs 37 – 39, General documentation requirements 47 – 50

I22 40 Specific documentation requirements for corrosive substances

I23 Reg 41 Specific documentation requirements for ecotoxic substances

I28 Reg 46 Specific documentation requirements for toxic substances

I29 Regs 51, 52 Signage requirements

I30 53 Advertising corrosive and toxic substances

Hazardous Substances (Packaging) Regulations 2001

Code Regulation Description

P1 Regs 5, 6, General packaging requirements 7(1), 8

P3 Reg 9 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria

P13 Reg 19 Packaging requirements for toxic substances

P14 20 Packaging requirements for corrosive substances

P15 Reg 21 Packaging requirements for ecotoxic substances

PG2 Schedule 2 Packaging requirements equivalent to UN Packing Group II

Application for reassessment of home-use chlorothalonil formulations (APP202349) 46

Code Regulation Description

PS4 Schedule 4 Packaging requirements as specified in Schedule 4

Hazardous Substances (Disposal) Regulations 2001

Code Regulation Description

D4 Reg 8 Disposal requirements for toxic and corrosive substances

D5 Reg 9 Disposal requirements for ecotoxic substances

D6 Reg 10 Disposal requirements for packages

D7 Regs 11, 12 Information requirements for manufacturers, importers and suppliers, and persons in charge

D8 Regs 13, 14 Documentation requirements for manufacturers, importers and suppliers, and persons in charge

Hazardous Substances (Emergency Management) Regulations 2001

Code Regulation Description

EM1 Regs 6, 7, 9 – Level 1 information requirements for suppliers and persons in charge 11

EM2 8(a) Information requirements for corrosive substances

EM6 Reg 8(e) Information requirements for toxic substances

EM7 Reg 8(f) Information requirements for ecotoxic substances

EM8 Regs 12 – 16, Level 2 information requirements for suppliers and persons in charge 18 – 20

EM11 Regs 25 – 34 Level 3 emergency management requirements: duties of person in charge, emergency response plans

EM12 35 – 41 Level 3 emergency management requirements: secondary containment

EM13 Reg 42 Level 3 emergency management requirements: signage

Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001

Code Regulation Description

AH 1 Regs 4 – 6 Approved Handler requirements (including test certificate and qualification requirements) Refer to control code E7

Hazardous Substances (Tracking) Regulations 2001

Code Regulation Description

Application for reassessment of home-use chlorothalonil formulations (APP202349) 47

Code Regulation Description

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

Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004

Code Regulation Description

Tank Regs 4 to 43 Controls relating to tank wagons and transportable containers Wagon as applicable

Additional controls

Code Section of Control the Act

Water 77A This substance must not be applied into or onto water16

No Home 77A The substance must not be supplied to any person unless — Use a) The person provides evidence at the time of supply that the substance is required for use in a workplace17; and b) In the relevant circumstances it is reasonable to believe that evidence. This substance must only be used or stored in a workplace.

77A The maximum level of hexachlorobenzene in the active ingredient chlorothalonil is set at 0.04 g/kg. The maximum level of decachlorobiphenyl in the active ingredient chlorothalonil is set at 0.03 g/kg.

Sch 8 Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 applies, with Clause 1 replaced by the following: This Schedule applies to every stationary container system that contains, or is intended to contain the substance.

16 where ‘water‘ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application. 17 A workplace has the same meaning as the Health and Safety at Work Act 2015

Application for reassessment of home-use chlorothalonil formulations (APP202349) 48

Appendix G: Science memo

APP202349 – Chlorothalonil Substance database ID5255 (Bravo, HSR000480) ID41821 (Greenguard, HSR000147) ID41820 (Guardall, HSR000586) ID5859 (Fungus & Mildew Spray; Black spot & Fungus spray, HSR000618) ID45726 (Tui Disease Eliminator RTU, HSR100872)

November 2015

Application for reassessment of home-use chlorothalonil formulations (APP202349) 49

1. Executive summary

1.1 Background and justification for the reassessment

1.1.1 In 2014 EPA staff received an application that sought approval to import or manufacture a new substance containing chlorothalonil that was intended for use as a fungicide, and to be sold and marketed to home gardeners (EPA application APP202057). For this application EPA staff conducted a quantitative human health risk assessment to estimate the likely exposure of people to chlorothalonil when the substance was used in home garden environments. The risk assessment took into account information about the human toxicity of chlorothalonil and the proposed use pattern of the substance, and then used models to predict the exposures to people (users and bystanders).

1.1.2 The results of the quantitative human health risk assessment identified that there would be risks greater than the level of concern to users and bystanders from the use of the chlorothalonil-containing substance in home garden settings. The application was assessed by a Decision Making Committee (DMC) which concluded that the application should be declined because the positive effects associated with approving the substance would not outweigh the adverse effects.

1.1.3. The EPA is aware that there are a number of chlorothalonil-containing fungicide products currently marketed and sold to home gardeners in New Zealand. The DMC for APP202057 recommended that there should be a targeted review of these existing substances so that those which also pose an unacceptable human health risk can be excluded from the market. The HSNO approvals and trade names (where known) of these products are listed in Table 1, below.

Table 1 Identity of chlorothalonil-containing fungicide products currently marketed and sold to home gardeners Known trade name(s) HSNO Approval HSNO Approval name ACVM registration number number Yates Bravo HSR000480 Suspension concentrate P002945 containing 500 g/L chlorothalonil (Substance B)

Yates Greenguard HSR000147 Suspension concentrate P004469 containing 102 g/L chlorothalonil and 125 g/L thiophanate methyl

Yates Guardall HSR000586 Suspension concentrate P004666 containing 62.5 g/L chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 g/L thiophanate methyl

McGregor’s Black Spot HSR00061818 Suspension concentrate P005865

18 The product “Taratek 5F” (ACVM registration number: P003937) is also covered by this HSNO approval. However, this product is not marketed or sold to home gardeners and is sold commercially in quantities >200 mL. Under the current controls that apply to this approval packaged quantities >200 mL must be under the control of an approved handler.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 50

Known trade name(s) HSNO Approval HSNO Approval name ACVM registration number number and Fungus Spray; containing 250 g/L chlorothalonil and 250 g/L thiophanate methyl Watkins Fungus and P005851 Mildew Spray

Tui Disease Eliminator for HSR100872 Tui Disease Eliminator (ready to P008984 Fruit and Veges RTU use)19

1.1.4 An application (APP202348) to determine whether there are grounds for a reassessment of chlorothalonil was made in May 2015, and grounds were established on this basis.

1.2 Key points

1.2.1 Some chlorothalonil-containing fungicide products in this reassessment contain two other active ingredients, thiophanate methyl and tau-fluvalinate. The exposure modelling has only been performed for the active ingredient chlorothalonil, although a qualitative review of the other active ingredients present in the substances can be found in paragraph 3.6.

1.2.2 Classification of the chlorothalonil-containing fungicide products was done by mixture rules. No study data on the formulations were received by the EPA.

1.2.3 The result of the quantitative human health risk assessment showed the risks to operators are greater than the level of concern for spray application for all products, as exposure to the active ingredient chlorothalonil exceeds the AOEL20 by 116 to 3900% (RQ: 1.16 – 39.10).

1.2.4 Furthermore, based on the skin sensitising properties of the products and the eye corrosive properties of all formulations but Tui Disease Eliminator RTU, PPE is recommended (protective gloves, eye/face protection).

1.2.5 In a home use setting, EPA staff do not consider it is appropriate to assume that people will either wear the correct PPE or use it properly (i.e. wash/store it appropriately and replace it when necessary).

1.2.6 For persons re-entering the treated area the Risk Quotient (RQ) for all products are greater than the level of concern (>1), and the risk assessment showed that the use of PPE and restricted entry intervals are necessary.

1.2.7 The REI interval without gloves would be 26-70 days; however EPA staff do not consider it is appropriate to assume that a REI interval can be set in a home use setting.

19 Contains 1.5 g/L chlorothalonil 20 Acceptable Operator Exposure Level

Application for reassessment of home-use chlorothalonil formulations (APP202349) 51

1.2.8 The Risk Quotient (RQ) for the exposure of a toddler is more than 39 to 108 times higher than the acceptable RQ of 1. Therefore the risks to bystanders (e.g. children) from the use of all products are not acceptable.

1.2.9 There are a significant number of data gaps which have meant that the staff have had to adopt a precautionary approach in the risk assessment. The risk assessment results could be revised if more information is provided about the following factors.

 Application rates, frequencies and intervals.

 Typical application areas and time spent by an operator applying the substance.

 Dermal absorption data for the spray, the concentrate, or the active ingredient.

 Dislodgable foliar residues (DFR) for treated crops

 Foliar half-life of the product

 Any studies of operator, re-entry or bystander exposure for persons using chlorothalonil.

1.2.10 Based on the hazard classifications (corrosive, skin sensitiser and suspected carcinogen) chlorothalonil is restricted from home use in Europe. Furthermore, there are still risk concerns and uncertainties in the risk assessments that have been carried out in other countries.

1.2.11 FAO21 has set impurity specifications for chlorothalonil.

 The maximum level of hexachlorobenzene in the active ingredient chlorothalonil is set at 0.04 g/kg.

 The maximum level of decachlorobiphenyl in the active ingredient chlorothalonil is set at 0.03 g/kg.

1.2.12 These impurity limits should be applied to the chlorothalonil-containing fungicide products mentioned in table 1.

1.3 Regulatory status

Table 2 Active ingredient(s) regulatory status Active ingredient name Regulatory history in New International regulatory Zealand history (Australia, Canada, Europe, Japan, USA) Chlorothalonil Products containing this active Approved in Australia, Canada, ingredient are approved for use in Europe, Japan, and USA. NZ Restricted from home use in the

21 Food and Agriculture Organization of the United Nations

Application for reassessment of home-use chlorothalonil formulations (APP202349) 52

Active ingredient name Regulatory history in New International regulatory Zealand history (Australia, Canada, Europe, Japan, USA) Europe Australia: listed in the priority candidate review list of the APVMA’s chemical review programme US EPA: under review. Concerns due to residential exposure inhalation risk. Canada: strict controls on labels (additional PPE, restricted-entry interval, a reduced max. appl. rates on golf courses)

1.4 Use pattern

Table 3 Substance use pattern Wide Application rate(s) Substance Dispersive Concentration Label Directions used in exposure category use assessment22 Yates Bravo No 500 g/L Mix 3ml per litre of water 1500 g ai./ha chlorothalonil (15ml per 5 litters)

Yates No 102 g/L Ornamentals, vegetables, Ornamentals, vegetables, fruit: 1500 g Greenguard chlorothalonil fruit: 5-10 ml per litter of ai./ha water. 125 g/L thiophanate methyl Turf, lawns, cotula: Turf, lawns, cotula: 4080 30-40ml per litre of water g ai./ha per 10m2

Yates Guardall No 62.5 g/L Ornamentals, Tomatoes, 1500 g ai./ha chlorothalonil, 9.6 Stone fruit: 10 mL per litter g/L tau-fluvalinate of water 62.5 g/L Cabbages: 15mL per litter thiophanate methyl of water

McGregor’s No 250 g/L Ornamentals, fruit, 1500 g ai./ha Black Spot and chlorothalonil and vegetables: 5ml/2L Fungus Spray; 250 g/L Beans: 10ml/2L Watkins Fungus thiophanate methyl

22 When the applicant has not provided the application rate; the application rate recommended by the New Zealand Novachem Agrichemical Manual is used.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 53

Wide Application rate(s) Substance Dispersive Concentration Label Directions used in exposure category use assessment22 and Mildew Spray

Tui Disease No 1.5 g/L Spray thoroughly, 1500 g ai./ha Eliminator for chlorothalonil including underside of Fruit and Veges leaves, re-apply if it rains RTU within 6 hours.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 54

2 Staff human health hazard classifications

2.1 All classifications in Table 4 are calculated based on mixture rules as no information was provided to support a claim that the classifications of the original transferred substances apply to these particular product formulations. Applicants should be given the opportunity to provide updated composition information, product data, or justifications to read across from the transferred substances during the submission period.

Table 4 HSNO Human Health Classifications Known trade HSNO HSNO Approval name Current Proposed name(s) Approval HSNO HSNO number Classifications Classifications Yates Bravo HSR000480 Suspension concentrate 6.1E (oral), 6.3B, 6.1B (inhalation), containing 500 g/L 6.4A, 6.5B, 6.7B, 8.3A, 6.5B, 6.7B, chlorothalonil (Substance 6.9A (All), 9.1A, 6.9A (oral), 9.1A, B) 9.2B, 9.3B23 9.2C, 9.3B

Yates Greenguard HSR000147 Suspension concentrate 6.1E (oral), 6.3B, 6.1C (inhalation), containing 102 g/L 8.3A, 6.5B, 6.6B, 8.3A, 6.5B, 6.6B,

chlorothalonil and 125 g/L 6.7B , 6.9A (All), 6.7B, 6.9B (oral), thiophanate methyl 9.1A, 9.2B, 9.3C24 9.1A, 9.2C, 9.3C

Yates Guardall HSR000586 Suspension concentrate 6.1D (inhalation), 6.1D (inhalation), containing 62.5 g/L 8.3A, 6.5B, 6.6B, 8.3A, 6.5B, 6.6B, chlorothalonil, 9.6 g/L tau- 6.7B, 6.9B (All), 6.7B, 6.9B (oral), fluvalinate and 62.5 g/L 9.1A, 9.2C, 9.3C 6.9B (dermal), 9.1A, thiophanate methyl 9.2C, 9.3C

McGregor’s Black HSR000618 Suspension concentrate 6.1B (inhalation), 6.1B (inhalation), Spot and Fungus containing 250 g/L 6.4A, 6.6B, 6.7B, 6.3B, 8.3A, 6.5B, Spray; chlorothalonil and 250 g/L 6.9A (All), 9.1A, 6.6B, 6.7B, 6.9A thiophanate methyl 9.2B, 9.3C25 (oral), 9.1A, 9.2C, Watkins Fungus and 9.3C Mildew Spray

Tui Disease HSR100872 Tui Disease Eliminator 6.5B, 6.7B, 9.1B 6.5B, 6.7B, 9.1C Eliminator for Fruit (ready to use) and Veges RTU

23 Classified based on company MSDS dated 15/08/03. In 2014, staff requested company SDS showing that the classifications are correct for acute inhalation toxicity and skin-& eye corrosion. No product data has been received. 24 Classified based on information supplied by registrant, appears to mainly be based on the company MSDS provided for Yates Bravo. 25 Product data was provided on the product Taratek 5F, which uses the same approval number. A read across justification is needed to decide if studies provided on Taratek 5F are applicable to McGregor’s Black Spot and Fungus Spray and Watkins Fungus and Mildew Spray.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 55

3 Quantitative human health risk assessment

3.1 Quantitative operator risk assessment

3.1.1 Critical endpoint definition

Has an AOEL26 already been set by an internationally reputable regulatory authority accepted by EPA?

Yes No

Table 5: Using an existing threshold for Chlorothalonil

Available Uncerta Key systemic mg/kg mg/kg Staff’s international inty effect bw/day bw/day modifications threshold factors

Chronic study rat; 1.8 mg/kg bw/day (30% oral absorption). Kidney and (fore) stomach (pre- NOAEL: AOEL: EFSA 100 none neoplastic and neoplastic 2.7 0.009 lesions). Most relevant NOAEL for setting the AOEL: 2.7 mg/kg bw/day

2-year dietary study in rats; increased kidney weights and hyperplasia of the US EPA proximal convoluted tubules NOEL: 2 100 RfD: 0.02 none in the kidneys as well as ulcers and fore stomach hyperplasia

3.1.2 Exposure models used for the risk assessment For the concentrate products the staff used the UK Predictive Operator Exposure Model (UK POEM) to estimate exposure to operator.27

For the ready to use product staff used the UK Predictive Operator Exposure Model (POEM) for amateur (home garden) to estimate exposure to operator.

26 The toxicological endpoint used for assessment of occupational (worker), re-entry worker and bystander risks is the AOEL (Acceptable Operator Exposure Level). The AOEL is the maximum amount of active substance to which the operator/re-entry worker may be exposed with a low probability of adverse health effects amongst the healthy worker sub-population, allowing for some margin of safety. AOELs describe the internal (absorbed) dose available for systemic distribution from any route of absorption and are expressed as internal (systemic) levels (mg/kg bw/day). They are derived by dividing the most appropriate NOAEL from relevant studies by one or more uncertainty (safety) factors selected on the basis of the extent and quality of the available data, the species for which data are available and the nature of the effects observed. An absorption factor may be applied to take into account the absorbed dose in the study where this is known (this is a percentage expressed as a factor); 27 UK Chemicals Regulation Directorate. UK POEM Operator exposure model. Available for download at http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/U/UK_POEM_07.xls

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For the exposure to bystander (children) and re-entry exposure after 24 hours, the staff used a risk assessment methodology similar to the United Kingdom Pesticide Safety Directorate’s approach.

3.1.3 Re-entry risk assessment The re-entry exposures were based on dermal exposure through contact with foliar residues only; inhalation exposure or exposure to other contaminated surfaces (e.g. soil) was not accounted for. Exposure following re-entry intervals were calculated using the formula below which was developed by other regulators (Chemicals Regulation Directorate, 2010b EUROPOEM, 2002).

Re-entry exposure = DFR x TC x WR x AR x DA BW

These parameters with default values where they exist are:

 DFR is the Dislodgeable Foliar Residue (3 µg/cm2 per kg a.i./ha)

 TC is the Transfer coefficient for the anticipated activity being performed (cm2/hr, see paragraph 3.1.4)

 WR is the work rate per day (0.5 hrs/day)

 AR is the Application rate (kg/ha)

 BW is the Body weight (60 kg)

 DA is the dermal absorption, expressed as a proportion. (see paragraph 3.2)

3.1.4 Transfer coefficients

Transfer coefficients (TC) refer to the amount of contact between a re-entry person and foliage. These are regarded as independent of the active ingredient/product used and depend on the crop type and the activity that the re-entry worker is carrying out (EUROPOEM, 2002). In the absence of data, the values in the table below were used which were obtained from overseas regulators.

Table 6: Default transfer coefficients used for the re-entry risk assessment Transfer Source of transfer Crop Activity coefficient coefficient (cm2/hr) Vegetables Reach/Pick 2500 (EUROPOEM, 2002) Fruit from trees Search/Reach/Pick 4500 (EUROPOEM, 2002) Berries Reach/pick 3000 (EUROPOEM, 2002)

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Ornamentals Cut/Sort/Bundle/Carry 5000 (EUROPOEM, 2002) NOHSC re-entry Turf Mowing 1000 exposure model Transplanting, hand NOHSC re-entry Turf 20000 weeding exposure model

These transfer coefficients all assume that re-entry persons are wearing long trousers and long sleeved T shirts and are not wearing gloves. It should be noted that this assumption may not necessarily always be reflective of practices in New Zealand.

3.1.5 Impact of wearing PPE

When appropriate information is available, the transfer coefficients suggested in the EUROPOEM document have been divided between hand exposure and rest-of-body exposure. From this information the exposure of re-entry persons wearing chemical resistant gloves is estimated. In the absence of other information, the model assumes that chemical resistant gloves reduce hand exposure by 90%, a default used by other regulators (TNO, 2010; California Environmental Protection Agency, 2010). Such revised TC are shown in the table below.

It should be noted that this assumption is not reflective of the practice with consumer use.

The impact of wearing gloves cannot be calculated for some crops/activities since TC attributable to hands only are not available.

Table 7: Impact of gloves on re-entry persons transfer coefficients

Transfer coefficients attributable to Transfer Transfer Transfer hand exposure coefficients for coefficients coefficients for re- assuming 90% Crop persons not attributable to entry persons reduction in wearing gloves hand exposure wearing gloves hand exposure (cm2/hr) (cm2/hr) (cm2/hr) due to wearing gloves (cm2/hr)

Vegetables 2500 2200 220 520 Ornamentals 5000 4000 400 1400

Berries 3000 2500 250 750 Fruit trees 4500 2500 250 2250

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3.1.6 Multiple applications

The effect of multiple applications on re-entry exposure was considered. The DFR is the only parameter that is altered by multiple applications.

th The DFR was estimated immediately following the n application (DFRn(a)) by assuming first order dissipation and using the following equation derived from the FOCUS guidance (FOCUS, 2010):

-nki -ki DFRn(a) = DFRsingle-application x (1-e )/(1-e )

Where n is the number of applications k is the rate constant for foliar dissipation i is the interval between applications (days)

As k is unknown, the FOCUS default of 0.0693, corresponding to a half-life foliar of 10 days, was used (FOCUS Working Group on Surface Water Scenarios, 2003).

The reduction in DFRn(a) over time after last application was then given by:

-kt DFRn(a)+t = DFRn(a) x e

where t is days since last application.

3.1.7 Risks to re-entry persons after 24 hours

The risk to re-entry persons 24 hours after the final treatment were calculated using the following equations.

-kt DFRn(a)+t = DFRn(a) x e

when t = 1 (24 h post-treatment)

The absorbed dose was calculated by:

-k DFRn(a) x e x C x D

Where C = TC x WR x AR/BW D = Dermal absorption

Therefore the risk to re-entry persons 24 h after the final application were given by the following equation:

-k RQ = DFRn(a) x e x C x D/AOEL

3.1.8 Calculation of Re-Entry Intervals (REI)

REIs were determined as being the day when the exposure multiplied by the dermal absorption equals the AOEL, i.e.

DFRn(a)+t x C x D = AOEL

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-kt Substituting DFRn(a) x e for DFRn(a)+t, setting t as the REI (R) and rearranging the equation, gives:

-kR DFRn(a) x e x C x D = AOEL

-kR e = AOEL/DFRn(a) x C x D

kR e = DFRn(a) x C x D/AOEL

R = ln(DFRn(a) x C x D/AOEL)/k

3.1.9 Bystander risk assessment EPA staff have assessed the risks to children re-entering a treated area after application. Children are expected to be most at risk due to their potential for high amounts of contact and hand to mouth exposure, exploratory nature and low body weight. Exposure was estimated using the equations from the UK Chemical Regulation Directorate (CRD) which account for dermal exposure, hand-to-mouth exposure and object-to- mouth exposure (Chemicals Regulation Directorate, 2010). In addition, incidental ingestion of soil is taken into account using a modified exposure equation from the United States Environmental Protection Agency (US EPA, 2007).

The modelling includes a number of assumptions and uncertainties. It was assumed that the toddler would be exposed to the application rate (i.e. a spray drift value of 100%) which could potentially overestimate exposure (assumes spray stays on the surface where it is applied and there is no dissipation before or during exposure).

3.1.9.1 Children’s dermal exposure Systemic exposures via the dermal route were calculated using the following equation (Chemicals Regulation Directorate, 2010): SE (d) = AR x DF x TTR x TC x H x DA BW Where:

SE(d) = systemic exposure via the dermal route

AR = application rate (µg/cm2)

DF = spray drift value (assumed to be 100%)

TTR = turf transferable residues – the US EPA default value of 5 % was used.

TC = transfer coefficient – the standard US EPA value of 5200 cm2/h was used for the estimate

H = exposure duration for a typical day (hours) – this was assumed to be 2 hours which matches the 75th percentile for toddlers playing on grass in the US EPA Exposure Factors Handbook

DA = percent dermal absorption

BW = body weight – 15 kg which is the average of UK 1995-7 Health Surveys for England values for males and females of 2 and 3 yrs

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3.1.9.2 Children’s hand-to-mouth exposure Hand-to-mouth exposures were calculated using the following equation (Chemicals Regulation Directorate, 2010): SE(h) = AR x DF x TTR x SE x SA x Freq x H BW Where:

SE(h) = systemic exposure via the hand-to-mouth route

AR = application rate (µg/cm2)

DF = spray drift value (assumed to be 100%)

TTR = turf transferable residues – the US EPA default value of 5% derived from transferability studies with wet hands was used.

SE = saliva extraction factor – the default value of 50% will be used

SA = surface area of the hands – the assumption used was that 20 cm2 of skin area is contacted each time a child puts a hand in his or her mouth (this is equivalent to the palmer surface of three figures and is also related to the next parameter (Freq))

Freq = frequency of hand to mouth events/hour – for short term exposures the value of 20 events/hour was used, this is the 90th percentile of observations that ranges from 0 to 70 events/hour

H = exposure duration (hours) – this will be assumed to be 2 hours (as above)

BW = body weight - 15kg (as above)

3.1.9.3 Children’s object-to-mouth exposure Object to mouth exposures were calculated using the following equation (Chemicals Regulation Directorate, 2010): SE(o) = AR x DF x TTR x IgR BW Where:

SE(o) = systemic exposure via mouthing activity

AR = application rate (µg/cm2)

DF = spray drift value (assumed to be 100%)

TTR = turf transferable residues: the default value of 20% transferability from object to mouth assessments was used.

IgR = ingestion rate for mouthing grass/day – this was assumed to be equivalent to 25 cm2 of grass/day

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BW = body weight - 15kg (as above)

3.1.9.4 Children’s incidental ingestion of soil The approach that was used to calculate doses attributable to soil ingestion is (US EPA, 1997):

ADOD = AR (μg/cm2) x DF x F (cm) x IgR (mg/day) x SDF (cm3/mg) BW (kg) Where:

ADOD = oral dose on day of application (μg/kg bw/day)

AR = application rate (µg/cm2)

DF = spray drift value (assumed to be 100%)

F = fraction or residue retained on uppermost 1 cm of soil (%) (Note: this is an adjustment from surface area to volume)

SDF = soil density factor - volume of soil (cm3) per milligram of soil

IgR = ingestion rate of soil (mg/day)

BW =body weight (kg)

Assumptions:

F = fraction or residue retained on uppermost 1 cm of soil is 100 percent based on soil incorporation into top 1 cm of soil after application (1.0/cm)

IgR = ingestion rate of soil is 100 mg/day

SDF = soil density factor - volume of soil (cm3) per gram of soil; to weight 6.7 x 10-4 cm3/mg soil)

BW = body weight of a toddler is 15 kg (as above)

3.1.9.5 Children’s total exposure Total exposure was calculated as the sum of the above equations:

∑ Exposure = SE (d) + SE (h) + SE (o) + ADOD

Risk quotients were estimated by comparing predicted exposure to the AOEL.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 62

3.2 Other inputs for the exposure modelling

The default value used in the model for exposure duration (duration of spraying) is 30 minutes. The area treated is assumed to be 0.01 ha/day (or 100 m2).

A default body weight of 60 kg is used for non-professional users. Infants are considered to be 6 to 12 months old, both male and female, with a mean body weight of 9 kg. Toddlers are considered to be 18 months to 4 years old, both male and female, with a mean body weight of 15 kg.

The model assumes that no PPE is worn.

No formulation data on dermal absorption is available for any of the products under review. Default dermal absorption values were taken from Aggarwal et al., 201528: liquid concentrates: 6%; solid concentrates (including granules): 2%; spray dilutions: 30%.

Application rates and concentrations used depended on the products assessed. Because the product is used by the general public we have calculated the direct exposure of a toddler or infant within the application area.

Table 8 Derivation of dermal absorption value in humans

Physical Concentration of Dermal absorption (%) Substance form each active Concentrate Spray (g/L)

Yates Bravo liquid 500 g/L chlorothalonil 6 30 (HSR0004801)

Yates Greenguard liquid 102 g/L chlorothalonil 6 30 (HSR000147)

Yates Guardall liquid 62.5 g/L chlorothalonil 6 30 (HSR000586)

McGregor’s Black Spot and Fungus Spray; Watkins Fungus and liquid 250 g/L chlorothalonil 6 30 Mildew Spray (HSR000618)

Tui Disease Eliminator for Fruit and Veges RTU liquid 1.5 g/L chlorothalonil NA - RTU 30 (HSR100872)

28 http://www.sciencedirect.com/science/article/pii/S0273230015000458

Application for reassessment of home-use chlorothalonil formulations (APP202349) 63

3.2 Output of human operator spraying exposure modelling

Table 9 Estimated operator exposure McGregor’s Black Spot and Fungus Tui Disease Spray; Yates Bravo Yates Eliminator for Yates Guardall Watkins Greenguard Fruit and (HSR000586) Fungus and (HSR000480) (HSR000147) Veges RTU Mildew Spray (HSR100872)

(HSR000618)

Ornamentals, Ornamentals, vegetables, Ornamentals, Ornamentals, Vegetables, Crop vegetables, fruit fruit, turf, lawns, vegetables, fruit vegetables, fruit fruit cotula

Ai content substance 500 102 62.5 250 1.5

(g/L)

Ornamentals, vegetables, Dose of product fruit: 10 3 15 5 NA - RTU29 (L/ha) Turf, lawns, cotula: 40

Ornamentals, vegetables, Application rate fruit: 1500 1500 1500 1500 1500 (g/ha) Turf, lawns, cotula: 4080

Ornamentals, vegetables, Application fruit: 1000 1000 1000 1000 NA - RTU volume (L/ha) Turf, lawns, cotula: 1000

Work rate/day (ha) 0.01 0.01 0.01 0.01 0.01

29 The UK Predictive Operator Exposure Model (POEM) for amateur (home garden) is used for the ready to use product. This model has no input on dose of product and application volume.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 64

McGregor’s Black Spot and Fungus Tui Disease Spray; Yates Bravo Yates Eliminator for Yates Guardall Watkins Greenguard Fruit and (HSR000586) Fungus and (HSR000480) (HSR000147) Veges RTU Mildew Spray (HSR100872)

(HSR000618)

Duration of 0.5 0.5 0.5 0.5 0.5 spraying (hrs)

Ornamentals, Operator vegetables, exposure fruit: 0.103 0.222 0.088 0.151 0.010

(mg/kg bw/day) Turf, lawns, cotula: 0.351

AOEL 0.009 0.009 0.009 0.009 0.009 (mg/kg bw/day)

Ornamentals, vegetables, RQ fruit: 11.45 24.62 9.83 16.81 1.16 (Exposure/AOEL) Turf, lawns, cotula: 39.01

3.2.1 Outcomes of the operator exposure assessment The risks to operators are greater than the level of concerns for spray application for all products, as exposure to the active ingredient chlorothalonil exceeds the AOEL by 116 to 3900% (RQ: 1.16-39.01).

Furthermore, based on the skin sensitising properties of the products and the eye corrosive properties of all formulations but Tui Disease Eliminator RTU, PPE is recommended (protective gloves, eye/face protection).

In a home use setting, EPA staff do not consider it is appropriate to assume that non-professionals will wear the correct PPE.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 65

3.3 Output of the re-entry exposure assessment:

Table 10 Re-entry exposure modelling30 McGregor’s Black Spot and Fungus Spray; Tui Disease Yates Bravo Yates Watkins Fungus Eliminator for Yates Guardall Greenguard and Mildew Fruit and (HSR000586) (HSR000480) (HSR000147) Spray Veges RTU (HSR100872) (HSR000618)

Ornamentals, Ornamentals, Ornamentals, Ornamentals, Vegetables, Crop vegetables, fruit, vegetables, fruit vegetables, fruit vegetables, fruit fruit turf, lawns, cotula

Ai content substance 500 102 62.5 250 1.5

(g/L)

Product: 6 Product: 6 Product: 6 Product: 6 Dermal Spray: 30 absorption (%) Spray: 30 Spray: 30 Spray: 30 Spray: 30

Ornamentals, vegetables, fruit: Application 1500 1500 1500 1500 1500 rate (g/ha) Turf, lawns, cotula: 4080

Frequency31 4 4 4 4 4

Interval (days) 7 10 7 10 10

DT50 (days) 10 10 10 10 10

Transfer Vegetables - Turf Vegetables - Vegetables - Vegetables - coefficient reach/pick: 2500 irrigation/mowing: reach/pick: 2500 reach/pick: 2500 reach/pick:

30 The Staff assessed the re-entry worker exposures using the generic exposure model for “Maintenance and harvesting activities: Dermal exposure” provided by the UK Health & Safety Executive chemical Regulation Directorate, on the following web site: http://www.pesticides.gov.uk/applicant_guide.asp?id=1246&link=%2Fuploadedfiles%2FWeb%5FAssets%2FPSD%2FRe%2Den try%2520worker%2520guidance%5Ffinal%2520version%2Epdf 31 No data on the frequency of use is provided by the applicants, so a default value of 4 times is used (this is the same value as was used in the Organophosphate and Carbamate reassessment, APP201045)

Application for reassessment of home-use chlorothalonil formulations (APP202349) 66

McGregor’s Black Spot and Fungus Spray; Tui Disease Yates Bravo Yates Watkins Fungus Eliminator for Yates Guardall Greenguard and Mildew Fruit and (HSR000586) (HSR000480) (HSR000147) Spray Veges RTU (HSR100872) (HSR000618)

1000 2500 (cm2/hr) Fruits (from Fruits (from Fruits (from trees) - Turf hand trees) - trees) - Fruits (from search/reach/pic weeding/transpla search/reach/pic search/reach/pic trees) - k: 4500 nting: 20000 k: 4500 k: 4500 search/reach/ pick: 4500 Berries - Vegetables - Ornamentals - Ornamentals - reach/pick: 3000 reach/pick: 2500 Cut/sort/bundle/c Cut/sort/bundle/c arry: 5000 arry: 5000 Ornamentals - Fruits (from trees) Cut/sort/bundle/c - arry: 5000 search/reach/pick : 4500

Berries - reach/pick: 3000

Ornamentals - Cut/sort/bundle/c arry: 5000

REI work rate 0.5 0.5 0.5 0.5 0.5 hours/day

Vegetables - Internal reach/pick: 0.06 Turf Vegetables - Vegetables - Vegetables - (absorbed) irrigation/mowing: reach/pick: 0.06 reach/pick: 0.05 reach/pick: Fruits (from dose available 0.05 0.05 trees) - for systemic Fruits (from Fruits (from search/reach/pic distribution, Turf hand trees) - trees) - Fruits (from k: 0.11 24 h after final weeding/transpla search/reach/pic search/reach/pic trees) - application Berries - nting: 1.07 k: 0.11 k: 0.09 search/reach/ without gloves reach/pick: 0.07 pick: 0.09 Vegetables - Ornamentals - Ornamentals - (mg/kg bw/0.5 Ornamentals - reach/pick: 0.05 Cut/sort/bundle/c Cut/sort/bundle/c hours) Cut/sort/bundle/c arry: 0.12 arry: 0.010 arry: 0.12 Fruits (from trees) - search/reach/pick : 0.09

Berries - reach/pick: 0.06

Application for reassessment of home-use chlorothalonil formulations (APP202349) 67

McGregor’s Black Spot and Fungus Spray; Tui Disease Yates Bravo Yates Watkins Fungus Eliminator for Yates Guardall Greenguard and Mildew Fruit and (HSR000586) (HSR000480) (HSR000147) Spray Veges RTU (HSR100872) (HSR000618)

Ornamentals - Cut/sort/bundle/c arry: 0.10

AOEL

0.009 0.009 0.009 0.009 0.009 (mg/kg bw/day)

Vegetables - RQ Vegetables - Turf Vegetables - Vegetables - reach/pick: reach/pick: 6.50 irrigation/mowing: reach/pick: 6.50 reach/pick: 5.47 5.47 (Exposure/AO 5.95 EL) Fruits (from Fruits (from Fruits (from Fruits (from trees) - Turf hand trees) - trees) - trees) - search/reach/pic weeding/transpla search/reach/pic search/reach/pic search/reach/ k: 11.69 nting: 118.96 k: 11.69 k: 9.84 pick: 9.84

Berries - Vegetables - Ornamentals - Ornamentals - reach/pick: 7.79 reach/pick: 5.47 Cut/sort/bundle/c Cut/sort/bundle/c arry: 12.99 arry: 10.93 Ornamentals - Fruits (from trees) Cut/sort/bundle/c - arry: 12.99 search/reach/pick : 9.84

Berries - reach/pick: 6.56

Ornamentals - Cut/sort/bundle/c arry: 10.93

3.3.1 Outcomes of the re-entry exposure assessment The Risk Quotient (RQ) for all products are > 1, this means the use of PPE for early crop entry (<24h) is recommended as necessary.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 68

The risks for re-entry at 24 hours without gloves are not acceptable for all activities. PPE (gloves) is recommended as necessary to reduce the risk. In a home use setting, EPA staff do not consider it is appropriate to assume that people will wear the correct PPE.

The REI interval without gloves would be 26-70 days (depending on the product and the activity); EPA staff do not consider it is appropriate to assume that a REI interval can be set in a home use setting.

3.4 Quantitative bystander risk assessment32

3.4.1 Critical endpoints definition The AOEL derived for operator and re-entry worker assessment above is also used for the bystander assessment calculations. The uncertainty factor for interspecies and intraspecies used for the derivation of the AOEL is sufficient to protect the larger part of the population, including children.

3.4.2 Output bystander (children)

As all the products are intended for home use, bystander risks were calculated based on direct contact of a toddler with treated surfaces.

Table 11 Output of bystander exposure McGregor’s Black Spot and Fungus Tui Disease Spray; Yates Bravo Yates Eliminator Yates Guardall Watkins Greenguard for Fruit and (HSR000586) Fungus and (HSR000480) (HSR000147) Veges RTU Mildew Spray (HSR100872)

(HSR000618)

Ornamentals, Ornamentals, Ornamentals, vegetables, Ornamentals, Vegetables, Crop vegetables, vegetables, fruit fruit, turf, lawns, vegetables, fruit fruit fruit cotula

Ai content 500 102 62.5 250 1.5 substance

32 The Staff considers that the main potential source of exposure to the general public for substances of this type (other than via food residues which will be considered as part of the registration of this substance under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997) is via spray drift. In terms of bystander exposure, toddlers are regarded as the most sensitive sub-population and are regarded as having the greatest exposures. For these reasons, the risk of bystander exposure is assessed in this sub-population. EPA has agreed that the AOEL used for operator and re-entry worker exposure assessment should be used for the bystander assessment, as the use of an oral chronic reference dose (CRfD) is usually likely to be over precautionary.

Application for reassessment of home-use chlorothalonil formulations (APP202349) 69

McGregor’s Black Spot and Fungus Tui Disease Spray; Yates Bravo Yates Eliminator Yates Guardall Watkins Greenguard for Fruit and (HSR000586) Fungus and (HSR000480) (HSR000147) Veges RTU Mildew Spray (HSR100872)

(HSR000618)

(g/L)

Product: 6 Product: 6 Product: 6 Product: 6 Dermal absorption Spray: 30 (%) Spray: 30 Spray: 30 Spray: 30 Spray: 30

Ornamentals, vegetables, Application rate fruit: 1500 1500 1500 1500 1500 (g/ha) Turf, lawns, cotula: 4080

Duration of 0.5 0.5 0.5 0.5 0.5 spraying (hrs)

Frequency33 4 4 4 4 4

Interval (days) 7 10 7 10 10

Exposure of 15 kg toddler exposed Ornamentals, through contact to vegetables, surfaces 0 m from fruit: 358.39 425.77 425.77 358.39 358.39 an application area Turf, lawns, cotula: 974.83 (µg/kg bw/day)

AOEL 0.009 0.009 0.009 0.009 0.009 (mg/kg bw/day)

Ornamentals, RQ 47.31 vegetables, 47.31 39.82 39.82

33 No data on the frequency of use is provided by the applicants, so a default value of 4 times is used (this is the same value as was used in the Organophosphate and Carbamate reassessment, APP201045)

Application for reassessment of home-use chlorothalonil formulations (APP202349) 70

McGregor’s Black Spot and Fungus Tui Disease Spray; Yates Bravo Yates Eliminator Yates Guardall Watkins Greenguard for Fruit and (HSR000586) Fungus and (HSR000480) (HSR000147) Veges RTU Mildew Spray (HSR100872)

(HSR000618)

fruit: 39.82 (Exposure/AOEL) Turf, lawns, cotula: 108.31

3.4.3 Outcomes of the bystander exposure assessment The Risk Quotient (RQ) for the exposure of a toddler is more than 39 to 108 times higher than the level of concern (RQ of 1). The risks to bystanders (e.g. children) from the use of all products are not acceptable.

3.5 Review of active ingredients other than chlorothalonil present in the substances to be reassessed

Thiophanate methyl Present in: HSR000147 - Suspension concentrate containing 102 g/litre chlorothalonil and 125 g/litre thiophanate methyl;

HSR000618 - Suspension concentrate containing 250 g/L chlorothalonil and 250 g/L thiophanate methyl

And, HSR000586 - Suspension concentrate containing 62.5 g/L chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 g/L thiophanate methyl

HSNO mammalian toxicity classifications Chlorothalonil: 6.1B (inhalation), 8.3A, 6.5B, 6.7B, 6.9A (oral)

Thiophanate methyl: 6.1E (oral), 6.1D (inhalation), 6.5B, 6.6B

AOELs Chlorothalonil: 0.009 mg/kg bw/day (SANCO, 2006) (Chronic study rat; NOAEL 2.7 mg/kg bw/day; 30% oral absorption; kidney and (fore)stomach (pre-neoplastic and neoplastic lesions)

Thiophanate methyl: 0.08 mg/kg bw/day (SANCO 2005) (1-y, dog: NOAEL 8 mg/kg bw/d; Liver, thyroid, kidney (increased weight, histopathological changes, changed clinicochemical parameters), anaemia

Application for reassessment of home-use chlorothalonil formulations (APP202349) 71

Summary Chlorothalonil has higher acute hazard classifications compared to thiophanate methyl. The only additional hazard classification that thiophanate methyl has is 6.6B.

Although thiophanate methyl is present at a slightly higher, or the same concentration as chlorothalonil, the AOEL for chlorothalonil is 9 times lower than that of thiophanate methyl (i.e. chlorothalonil is of much greater toxicity). Therefore the human health risks associated with the use of this substance are expected to be considerably greater from exposure to chlorothalonil than from thiophanate methyl exposure.

Tau-fluvalinate

Present in: HSR000586 - Suspension concentrate containing 62.5 g/L chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 g/L thiophanate methyl

HSNO mammalian toxicity classifications Chlorothalonil: 6.1B (inhalation), 8.3A, 6.5B, 6.7B, 6.9A (oral)

Tau-fluvalinate: 6.1C (oral), 6.4A, 6.9B (oral), 6.9B (dermal)

AOELs Chlorothalonil: 0.009 mg/kg bw/day (SANCO, 2006) (Chronic study rat; NOAEL 2.7 mg/kg bw/day; 30% oral absorption; kidney and (fore)stomach (pre-neoplastic and neoplastic lesions)

Tau-fluvalinate: AOEL 0.0044 mg/kg bw/day (EFSA, 2011) (rat (dietary) 90-d phase of the chronic study; 44% oral absorption; reduced body weight, body weight gain and food consumption)

Summary Tau-fluvalinate is much less hazardous than chlorothalonil in terms of human health hazards. The AOEL of chlorothalonil is two times higher than that of tau-fluvalinate, but the concentration of chlorothalonil is six times higher. Therefore the human health risks associated with the use of this substance are expected to be considerably greater from exposure to chlorothalonil than from tau-fluvalinate exposure. 3.6 Summary and conclusions of the human health risk assessment

The risks to operators are not acceptable for spray application for all products, as exposure to the active ingredient chlorothalonil exceeds the AOEL by 116 to 3900% (RQ:1.16-39.01).

Furthermore, based on the skin sensitising properties of all the products and the eye corrosive properties of all products but Tui Disease Eliminator RTU, PPE is required (protective gloves, eye/face protection).

In a home use setting, EPA staff do not consider it is appropriate to assume that people will either wear the correct PPE or use it properly (i.e. wash/store it appropriately and replace it when necessary).

The Risk Quotient (RQ) for re-entry persons for all products are > 1, this means the use of PPE for crop re- entry and restricted entry intervals are required.

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The risks for re-entry at 24 hours without gloves are not acceptable for all activities. The correct PPE (gloves) is recommended as necessary to reduce the risk, In a home use setting, EPA staff do not consider it is appropriate to assume that people will wear the correct PPE.

The REI interval without gloves would be 26-70 days, EPA staff do not consider it is appropriate to assume that a REI interval can be set in a home use setting.

The Risk Quotient (RQ) for the exposure of a toddler is more than 39 to 108 times higher than the level of concern (RQ of 1).

There are a significant number of data gaps which have meant that the staff have had to adopt a precautionary approach in the risk assessment. The risk assessment results could be revised if more information is provided about the factors listed in paragraph 1.2.9.

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4 Controls

4.1 Toxicity controls

Exposure Thresholds

Table 12 Active ingredient(s) exposure thresholds Active Acceptable Daily Potential Daily Tolerable Workplace Ingredient(s) Exposure (ADE) – Exposure (PDE) Exposure Limit Exposure mg/kg bw/d – mg/kg bw/d (TEL) Standard (WES34) mg/L (water) mg/kg (soil) mg/m3 (air) Chlorothalonil 0.03 Food: 0.03 Not set at this Not set at this time time Drinking water: 0.006

Table 13 Toxic property controls

Apply the Approved Handler Apply the Tracking Control Substance Controls - Highly Toxic - Highly Toxic Substances Substances (AH1, T6) (TR1):

Yates Bravo (HSR0004801) Yes Yes

Yates Greenguard (HSR000147) Yes Yes

Yates Guardall (HSR000586) No No

McGregor’s Black Spot and Fungus Yes Yes Spray; Watkins Fungus and Mildew Spray (HSR000618)

Tui Disease Eliminator for Fruit and No No Veges RTU (HSR100872)

Other toxicity controls FAO has set impurity specifications for chlorothalonil.

The maximum level of hexachlorobenzene in the active ingredient chlorothalonil is set at 0.04 g/kg. The maximum level of decachlorobiphenyl in the active ingredient chlorothalonil is set at 0.03 g/kg. The impurity limits should apply to all the chlorothalonil-containing fungicide products mentioned in table 1.

34 http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological- exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdf

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Appendix H: References

 Chemicals Regulation Directorate, Bystander Exposure Guidance, Available online at http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Bystander%20exposure%20guidance_ final%20version.pdf Accessed 27/01/2010a.

 Chemicals Regulation Directorate, Guidance for post-application (re-entry worker) exposure assessment. Available at http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Re- entry%20worker%20guidance_final%20version.pdf Accessed 16/08/2010b

 Chemicals Regulation Directorate, Bystander Exposure Guidance, Available online at http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Bystander%20exposure%20guidance_ final%20version.pdf%20Accessed%2027/01/2010a

 EFSA, 2010 Conclusion on the peer review of the pesticide risk assessment of the active substance tau-fluvalinate.

 EUROPOEM II project,2002 , Post application exposure of workers to pesticides in agriculture, report of the re-entry working group. FAIR-CT96-1406.

 FOCUS Working Group on Surface Water Scenarios, Focus surface water scenarios in the EU evaluation process under 91/414/eec SANCO/4802/2001-rev.2 final (May 2003)

 Mozzachio A.H. et. al, 2008, Chlorothalonil exposure and cancer incidence among pesticide applicator participants in the agricultural health study http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2936501/  Pest Management Regulatory Agency Health Canada, 2011, Proposed Re-evaluation Decision, PRVD2011-14, Chlorothalonil

 SANCO 2006; Review report for the active substance chlorothalonil

 SANCO, 2005; Review report for the active substance thiophanate-methyl

 TNO Effective Personal Protective Equipment (PPE); Available online at http://www.bozpinfo.cz/priloha/euroshnet_02.pdf

 US EPA, 2007, Standard Operating Procedures (SOPs) for Residential Exposure Assessments, Contract No. 68-W6-0030, Work Assignment No. 3385.102

 US EPA, 1999, Reregistration Eligibility Decision (Red) Chlorothalonil, EPA 738-R-99-004

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Appendix I: Glossary of terms Term Definition Ai active ingredient

Acute Adverse effect that occurs after a single exposure which usually lasts for a short time.

The Acceptable operator exposure level is the internal dose of a substance that an AOEL operator (worker) may be exposed to on a daily basis without the likelihood of an adverse toxicological effect.

A person who holds a current test certificate certifying that the person has met the Approved requirements of Hazardous Substances and New Organisms (Personnel Qualifications) Handler Regulations 2001 in relation to an approved handler for one or more hazard classifications or hazardous substances.

Benefit The value of a positive effect expressed either in monetary or non-monetary terms.

A substance that is solely designed for biocidal action as defined in Schedule 6 (1) of the Biocide Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001.

Adverse effect that occurs after a repeated exposure and which usually is long lasting Chronic and recurring.

Cost The value of an adverse effect expressed either in monetary or non-monetary terms.

DT50 Period required for 50% dissipation of a substance.

Endpoint Toxicological or ecotoxicological value used in the risk assessment

Exposure Human or environmental organism contact with a substance.

HSNO The Hazardous Substances and New Organisms Act 1996.

The median lethal concentration, being a statistically derived single concentration of a LC50 substance that can be expected to cause death in 50% of animals.

The median lethal dose, being a statistically derived single dose of a substance that can LD50 be expected to cause death in 50% of animals.

Likelihood The probability of an effect occurring.

LOAEL Lowest Observable Adverse Effect Level.

The Level of Concern is a point above which there is a risk of an adverse effect LOC occurring. For this reassessment the LOC is equivalent to a risk quotient of 1.

LOEL Lowest Observable Effect Level.

Magnitude Expected level of effect.

A mesocosm is an experimental tool that brings a small part of the natural environment Mesocosm under controlled conditions. Mesocosms can be used to evaluate how organisms or communities might react to environmental change.

NOAEL No Observed Adverse Effect Level.

NOEC No Observed Effect Concentration.

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Term Definition A period of time following a decision to revoke an approval that must elapse before the Phase-out revocation comes into force. This allows time to accommodate the revocation, including period disposal of existing stock.

Personal Protective Equipment including any item of equipment used to protect a person PPE from hazards e.g. safety helmet, goggles, gloves, boots, respirator.

A Restricted Entry Interval is the time which must elapse after application of a substance REI before entry into the treated area is permitted without use of PPE or RPE

RPE Respiratory Protective Equipment (a type of PPE).

The combination of the magnitude of an adverse effect and the probability of its Risk occurrence.

Risk quotient is the ratio of predicted exposure concentration to predicted no effect RQ concentration

Safety Data Sheets contain data regarding the properties of a substance and procedures SDS for handling or working with that substance.