Summary of Application & Staff Update Report Application - - PowerPoint PPT Presentation

Summary of Application & Staff Update Report

Application APP202349

EPA application team

Application Lead – Jeane Nicolas Toxicology Advisor – Jeane Nicolas Kaupapa Kura Taiao Advisor – Julian Jackson

24 February 2017

Background

Chlorothalonil is a fungicide to control fungal foliar diseases in vegetables, fruit, flowers and ornamental plants. It is intended to be used in commercial agriculture and home gardens. The staff carried out a risk assessment for an application (APP202057), which showed high risks to human health. This application was declined and the basis for Grounds for reassessment. The application was formally received on 25 October 2016.

Chlorothalonil- the international situation

EU: banned in consumer products (PPE & CMR). Australia: Listed in the Priority candidate review list. US EPA: Concerns residential exposure inhalation risk - revised occupational/residential exposure and risk assessment, and more than 50 toxicity and ecotoxicity studies are requested (March 2013). Canada: further risk-reduction measures for product labels (additional PPE, restricted-entry interval, <max.

• appl. rates on golf courses, and more).

Scope of the reassessment

Non-professional use of chlorothalonil formulations. One of the substances (HSR000618) is also used in professional setting. Grounds for reassessment were established for risk from home-use; the risks from professional use have not been considered in this application.

Risk assessment

Inputs for risk assessment

What is an acceptable level of exposure? How much are people exposed to?

Toxicity studies in laboratory animals Human data (where available) Uncertainty factors Exposure modelling/measurement

RISK

Stages of risk assessment

Hazard identification

What toxic effects are caused by the substance?

Hazard characterisation

At what dose levels do these effects occur? Are the effects relevant to humans?

Exposure assessment

How much of the substance are people exposed to and in what situations (work, home, play)?

Risk characterisation

Integration of information from the preceding steps to characterise the risks.

Hazard identification

Chlorothalonil is;

Highly and acutely toxic to humans following inhalation Corrosive to the eyes Causes contact sensitisation Suspected carcinogen to humans Target organ toxicity via oral route

Proposed hazard classifications

Substance name Approval number Current classification Preliminary classification

Suspension concentrate containing 500 g/L chlorothalonil (Substance B) HSR000480 6.1E (oral), 6.3B, 6.4A, 6.5B, 6.7B, 6.9A (All), 9.1A, 9.2B, 9.3B 6.1B (inhalation), 8.3A, 6.5B, 6.7B, 6.9A (oral), 9.1A, 9.2C, 9.3B Suspension concentrate containing 102 g/L chlorothalonil and 125 g/L thiophanate methyl HSR000147 6.1E (oral), 6.3B, 8.3A, 6.5B, 6.6B, 6.7B , 6.9A (All), 9.1A, 9.2B, 9.3C 6.1C (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, 6.9B (oral), 9.1A, 9.2C, 9.3C Suspension concentrate containing 62.5 g/L chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 g/L thiophanate methyl HSR000586 6.1D (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, 6.9B (All), 9.1A, 9.2C, 9.3C 6.1D (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, 6.9B (oral), 6.9B (dermal), 9.1A, 9.2C, 9.3C Suspension concentrate containing 250 g/L chlorothalonil and 250 g/L thiophanate methyl HSR000618 6.1B (inhalation), 6.4A, 6.6B, 6.7B, 6.9A (All), 9.1A, 9.2B, 9.3C 6.1B (inhalation), 6.3B, 8.3A, 6.5B, 6.6B, 6.7B, 6.9A (oral), 9.1A, 9.2C, 9.3C Tui Disease Eliminator (ready to use) HSR100872 6.5B, 6.7B, 9.1B 6.5B, 6.7B, 9.1C

EPA exposure assessment models

Estimates exposure, risk and the control measures necessary to manage the risk for the following “receptors”;

Operator (e.g. consumer) Bystander (e.g. children) Re-entry worker

EPA exposure assessment models

Operator - concentrate products: UK Predictive Operator Exposure Model (POEM). Operator - ready to use products: UK Predictive Operator Exposure Model (POEM) for amateur (home garden). Bystander (e.g. children) & re-entry worker: modification of the approach used by European regulators and the US EPA.

Risk assessment

Exposure estimate ÷ Acceptable Operator Exposure Level (AOEL) = Risk Quotient (RQ). If RQ ≤ 1: no concern for human health. If RQ > 1: there may be concern – needs further evaluation.

Performed risk assessment

HSNO Approval number Known trade name(s) Use Human Health Risk Assessment Environmental Risk Assessment HSR000480 Yates Bravo Domestic Quantitative Qualitative HSR000147 Yates Greenguard Domestic Quantitative Qualitative HSR000586 Yates Guardall Domestic Quantitative Qualitative HSR100872 Tui Disease Elminator for Fruit and Veges RTU Domestic Quantitative Qualitative HSR000618 McGregor’s Black Spot and Fungus Spray; Watkins Fungus and Mildew Spray Domestic Quantitative Qualitative Taratek 5F Professional Not assessed:

• utside the scope of this application

RQ > 1

Operator exposure

UK POEM & UK POEM for amateur (home garden). Some inputs of the operator exposure;

AOEL: 0.009 mg/kg bw/day (existing AOEL EFSA) Concentration of ai.: 1.5; 62.5; 102; 250; 500 g/L Dermal absorption*: 6% (concentrate); 30% (spray) Exposure duration: 30 min (default value) See Appendix G, Table 9, page 63 of the application

* Aggarwal et al. 2015

Result Operator exposure

The risks to operators are not acceptable for spray application for 30 minutes or more, as exposure to the active ingredient chlorothalonil exceeds the AOEL.

Yates Bravo (HSR000480) Yates Greenguard (HSR000147) Yates Guardall (HSR000586) McGregor’s Black Spot and Fungus Spray; Watkins Fungus and Mildew Spray (HSR000618) Tui Disease Eliminator for Fruit and Veges RTU (HSR100872) RQ (Exposure/AOEL) 24.62 Ornamentals, vegetables, fruit: 11.45 Turf, lawns, cotula: 39.01 9.83 16.81 1.16

Re-entry worker exposure

Modification of the approach used by European regulators and the US EPA. Inputs of the Re-entry worker exposure;

AOEL: 0.009 mg/kg bw/day (existing AOEL EFSA) Concentration of ai.: 1.5; 62.5; 102; 250; 500 g/L Dermal absorption: 6% (concentrate); 30% (spray) See Appendix G, Table 10, page 65 of the application

Result re-entry worker exposure

The Risk Quotient (RQ) > 1 = PPE for early crop entry (<24h)

* Depending on the activity

Yates Bravo (HSR000480) Yates Greenguard (HSR000147) Yates Guardall (HSR000586) McGregor’s Black Spot and Fungus Spray; Watkins Fungus and Mildew Spray (HSR000618) Tui Disease Eliminator for Fruit and Veges RTU (HSR100872) RQ* (Exposure/AOEL) 6.50 - 12.99 5.47 - 118.96 6.50 - 12.99 5.47 – 10.93 5.47 – 9.84

Bystander exposure

Modification of the approach used by European regulators and the US EPA. We do not estimate direct bystander exposure to spray drift, estimate the exposure of a toddler. Inputs of the bystander exposure:

AOEL: 0.009 mg/kg bw/day (existing AOEL EFSA) Concentration of ai.: 1.5; 62.5; 102; 250; 500 g/L Dermal absorption: 6% (concentrate); 30% (spray) See Appendix G, Table 11, page 68 of the application

Result Bystander exposure

The Risk Quotient (RQ) for the exposure of a toddler > 1.

Yates Bravo (HSR000480) Yates Greenguard (HSR000147) Yates Guardall (HSR000586) McGregor’s Black Spot and Fungus Spray; Watkins Fungus and Mildew Spray (HSR000618) Tui Disease Eliminator for Fruit and Veges RTU (HSR100872) RQ (Exposure/AOEL) 47.31 Ornamentals, vegetables, fruit: 39.82 Turf, lawns, cotula: 108.31 47.31 39.82 39.82

Summary results

Risks to operators/consumers are not acceptable. Risks for re-entry at 24 hours without gloves are not acceptable. Re-entry interval without gloves = 26-70 days. Risk Quotient (RQ) for the exposure of a toddler > 1. Based on the classifications, PPE is recommended (protective gloves, eye/face protection).

Multiple active ingredients

Thiophanate methyl (HSR000147; HSR000618; HSR000586)

Chlorothalonil has higher acute hazard classifications. Thiophanate methyl has additional 6.6B classification. AOEL chlorothalonil is 9x < AOEL thiophanate methyl. This means; risks from exposure to chlorothalonil > risks from exposure to thiophanate methyl

Multiple active ingredients (2)

Tau-fluvalinate (HSR000586)

Chlorothalonil has higher hazard classifications. AOEL chlorothalonil is 2x > AOEL tau-fluvalinate. Concentration chlorothalonil is 6x > concentration tau- fluvalinate. This means; risks from exposure to chlorothalonil > risks from exposure to tau-fluvalinate

Risk/benefit assessment

Risks

Non-negligible risks to human health Non-negligible risks to Māori

Benefits

Broad-spectrum activity Diversity of uses

The risks are not outweighed by the benefits and chlorothalonil use should be prohibited for the home- garden use.

Proposal of EPA staff

Proposed decision Approval number Substance name Product name Revoke approval – disposal of existing stocks within six months of decision HSR000480 Suspension concentrate containing 500 g/litre chlorothalonil (Substance B) Yates Bravo Revoke approval - disposal of existing stocks within six months of decision HSR000147 Suspension concentrate containing 102 g/L chlorothalonil and 125 g/L thiophanate methyl Yates Greenguard Revoke approval - disposal of existing stocks within six months of decision HSR000586 Suspension concentrate containing 62.5 g/L chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 g/L thiophanate methyl Yates Guardall Retain approval, with significant restrictions (Appendix F) Non-professional use to be phased out within 6 months unless industry can demonstrate non-professional use is safe HSR000618 Suspension concentrate containing 250 g/L chlorothalonil and 250 g/L thiophanate methyl McGregor’s Black Spot and Fungus Spray; Watkins Fungus and Mildew Spray Revoke approval - disposal of existing stocks within six months of decision HSR100872 Tui Disease Eliminator (ready to use) Tui Disease Eliminator for Fruit and Veges RTU

Proposed controls for HSR000618

Additional controls in accordance with s77A

Cannot be applied into, onto or over water. The substance must not be supplied to any person unless — a) The person provides evidence at the time of supply that the substance is required for use in a workplace ; and b) In the relevant circumstances it is reasonable to believe that evidence. This substance must only be used or stored in a workplace. Maximum content of hexachlorobenzene allowed in chlorothalonil is 0.04 g/kg. The maximum content of decachlorobiphenyl allowed in chlorothalonil is 0.03 g/kg. Classification will trigger: Approved handler; General tracking requirements; and Requirements for PPE (gloves, face shield).

Submissions received

Nine submissions were received. Eight submissions supported the application and

• ne opposed the application.

Four submitters requested to speak to their submissions at a hearing.

Revocation of approval HSR000618

Several submitters recommended that one approval (HSR000618) also should be revoked. The use of chlorothalonil substances in a professional setting should also be assessed. The Grounds were only established for risks from home-use, the risks from professional use are out of scope of this application. In order to revoke approval HSR000618, professional use would have to be reassessed.

Quantitative environmental risk assessment

Several submitters recommended that the EPA conduct a full quantitative environmental exposure and ecological risk assessment for chlorothalonil. Apply those findings to the present controls for all existing and future uses. Human health risks alone are sufficiently high to justify prohibiting home-garden use.

Adverse effects to the environment

Two submitters provided information on the adverse effects on the environment, specifically the effects on fish and aquatic invertebrates, and amphibians. The information was reviewed. We are aware of the information regarding the toxicity of chlorothalonil. Consideration of this information did not change

• ur assessment.

Effects on bees

Several submitters provided information on the effects on bees. We acknowledge that we have not assessed the effects on bees in this application. It is not necessary to assess the potential for this effect, given the scope of the application and that the recommendations are driven by the human health risks.

Identification of adjuvant properties and synergistic effects Two submitters stated that there is an incomplete identification of the adjuvant properties of the full McGregors and Watkins formulations. Hazardous properties of all components are taken into account for the formulations using mixture rules. EPA has performed a qualitative review of the second active ingredients.

Alternatives to chlorothalonil formulations

One submitter stated that several fungicides with lower hazard classifications are available. The EPA has noted the information provided, but do not consider that it changes the outcome of the assessment.

Staff Recommendation

The risk assessment shows non-negligible risks to human health for home-garden use. Four approvals should be revoked Additional controls should be applied to prevent use by non-professionals for HSR000618. Disposal of existing stocks of the home-use product approvals should occur within six months of the date of a decision on this application. Revised classifications and controls for HSR000618 should come into effect as soon as practicably possible (transitional period of twelve months should be sufficient).

Thank you