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 Exposure Toxicity studies in Human data modelling/measurement laboratory animals (where available) Uncertainty factors What is an How much are acceptable level of people exposed exposure? to? 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 Approval Substance name Current classification Preliminary classification number HSR000480 6.1B (inhalation), 8.3A , 6.5B, 6.7B, 6.9A Suspension concentrate containing 500 g/L 6.1E (oral), 6.3B, 6.4A, 6.5B, 6.7B, (oral), 9.1A, 9.2C , 9.3B chlorothalonil (Substance B) 6.9A (All), 9.1A, 9.2B, 9.3B HSR000147 6.1C (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, Suspension concentrate containing 102 g/L 6.1E (oral), 6.3B, 8.3A, 6.5B, 6.6B, 6.9B (oral), 9.1A, 9.2C, 9.3C chlorothalonil and 125 g/L thiophanate methyl 6.7B , 6.9A (All), 9.1A, 9.2B, 9.3C HSR000586 6.1D (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, 6.9B Suspension concentrate containing 62.5 g/L 6.1D (inhalation), 8.3A, 6.5B, 6.6B, (oral), 6.9B (dermal), 9.1A, 9.2C, 9.3C chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 6.7B, 6.9B (All), 9.1A, 9.2C, 9.3C g/L thiophanate methyl HSR000618 6.1B (inhalation), 6.3B, 8.3A, 6.5B, 6.6B, Suspension concentrate containing 250 g/L 6.1B (inhalation), 6.4A, 6.6B, 6.7B, 6.7B, 6.9A (oral), 9.1A, 9.2C, 9.3C chlorothalonil and 250 g/L thiophanate methyl 6.9A (All), 9.1A, 9.2B, 9.3C HSR100872 6.5B, 6.7B, 9.1C Tui Disease Eliminator (ready to use) 6.5B, 6.7B, 9.1B
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 Known trade Human Health Risk Environmental Risk Use number name(s) Assessment Assessment HSR000480 Yates Bravo Domestic Quantitative Qualitative HSR000147 Yates Greenguard Domestic Quantitative Qualitative HSR000586 Yates Guardall Domestic Quantitative Qualitative HSR100872 Tui Disease Domestic Quantitative Qualitative Elminator for Fruit and Veges RTU McGregor’s Black HSR000618 Domestic Quantitative Qualitative Spot and Fungus Spray; Watkins Fungus RQ > 1 and Mildew Spray Taratek 5F Professional Not assessed: outside the scope of this application
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. McGregor’s Black Spot and Tui Disease Eliminator Fungus Spray; Watkins Yates Bravo for Fruit and Veges Yates Greenguard Yates Guardall Fungus and Mildew Spray RTU (HSR000147) (HSR000586) (HSR000480) (HSR100872) (HSR000618) Ornamentals, vegetables, fruit: RQ 11.45 24.62 9.83 16.81 1.16 (Exposure/AOEL) Turf, lawns, cotula: 39.01
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) McGregor’s Black Spot and Fungus Spray; Tui Disease Yates Bravo Watkins Fungus and Yates Greenguard Yates Guardall Eliminator for Fruit Mildew Spray (HSR000147) (HSR000586) and Veges RTU (HSR000480) (HSR100872) (HSR000618) 5.47 – 10.93 5.47 – 9.84 RQ* 6.50 - 12.99 5.47 - 118.96 6.50 - 12.99 (Exposure/AOEL) * Depending on the activity
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. McGregor’s Black Spot Tui Disease and Fungus Spray; Yates Bravo Yates Eliminator for Watkins Fungus and Yates Guardall Greenguard Fruit and Veges Mildew Spray (HSR000586) (HSR000147) RTU (HSR000480) (HSR100872) (HSR000618) RQ 47.31 Ornamentals, 47.31 39.82 39.82 vegetables, fruit: 39.82 (Exposure/AOEL) Turf, lawns, cotula: 108.31
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.
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