OPERATOR EXPOSURE GUIDANCE FOR AMATEUR (HOME GARDEN) PESTICIDES CONTENTS (i) Packaging (ii) Classification and Personal Protective Equipment (iii) Exposure assessment – Users a) b) c) d) Spray Application Ready to Use Products - Aerosol and Trigger Sprays Dustable Powder formulations Granule application (iv) Exposure assessment – Bystanders (v) Exposure assessment – Children (spray applications) (vi) Exposure assessment – Children (granule applications) This document does not replace the approach outlined in the European Food Safety Authority (EFSA) guidance document[1] on the assessment of operator, worker and resident & bystander exposure to plant protection products, however it may be used in the absence of relevant guidance. The content of this document is to be reviewed and may be amended at any time. The applicant should ensure that where relied upon, the guidance reflects the latest edition issued on the HSE website. (i) Packaging The product should be supplied in appropriately sized packaging so that when applied in typical home garden situations all of the pesticide will be used within two seasons after purchase. For products supplied as concentrates, pack sizes up to 1 litre/kilogram will typically provide a sufficient volume for two seasons use. For larger pack sizes the applicant should justify the maximum pack size being sought by reference to the uses being proposed (in terms of application rates / number of applications) and the areas typically being treated. Please refer to the guidance document on pesticide containers for further details regarding limitations on maximum pack size. These requirements apply to all new product applications. For existing products, these will be applied either when changes to the conditions of approval are made which require technical evaluation by HSE or at re-registration. (ii) Classification and Personal Protective Equipment The appropriate PPE specified for a product is determined by two separate factors. The hazard classification of the product. Certain toxicological classification may require specific PPE to be worn e.g. an eye irritant may necessitate the wearing of a face shield when handling the concentrate. The PPE imposed depends upon the severity of the effects demonstrated in the toxicological tests and a qualitative consideration of the risk of exposure. Products are assessed on a case by case basis. PPE may also be required to reduce exposure to an acceptable level (i.e. to within the relevant reference dose) when using the product according to the label recommendations (e.g. opening, mixing, loading, applying, cleaning and handling contaminated surfaces). This will be based on a quantitative assessment of the risk to operators. Approval cannot be given for products used in the home garden sector where the use of personal protective equipment (PPE) is required to ensure the risk to users is within acceptable limits. (iii) Exposure assessment – Amateur Users [1] Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products: EFSA Journal 2014;12(10):3874 In the absence of specific usage information on the intended uses of a product, the following areas are considered as representative areas for home garden use; Lawn – 200 square metres Ornamentals – 50 square metres Fruit and vegetables – 50 square metres Patio and paths– 50 square metres a) Spray Application Exposure for home garden users applying pesticide sprays may be quantified using the UK Predictive Operator Exposure Model (UK POEM) for hand-held application. A specific exposure model for amateur users has been produced, which assumes a 5 litre hand-held sprayer is used to apply the spray solution, with the duration of the spray task taking approximately 30 minutes. Research commissioned by CRD has shown that levels of operator exposure when decanting home garden concentrates may differ from the UK POEM pouring values established for professional products. Reports of these studies on amateur packaging are available on the Defra website (PA1722 and PS2007). These studies demonstrate that: containers with integral squeeze-to-fill measuring chambers are likely to result in lower levels of contamination, and may be easier for amateurs to use, than containers which require the use of separate measuring equipment; and containers with measuring caps (or separate measures which are stored inverted on the cap after use) may result in higher levels of contamination from contact with product draining from the measure down the outside of the container). Based on these data, the following values have been agreed for the level of hand contamination when handling home garden liquid concentrates. These values have been included in the UK POEM spreadsheet for home garden use. Home garden, in-cap measure: 1 ml of formulation per pouring operation. Home garden, separate measure: 0.1 ml of formulation per pouring operation. Home garden integral squeeze-to-fill measuring chamber: 0.01 ml of formulation per pouring operation. b) Ready to Use Products - Aerosol and Trigger Sprays Levels of operator exposure for non-professionals when using products packaged in pre-pressurised aerosol cans and hand-held trigger spray containers can be estimated on the basis of the following data published on the European Chemicals Bureau (TNsG / TNSG on Human Exposure / Report 2002, Part 2, pages 194 to 197). These data were generated by the (UK) Health and Safety Laboratory (HSL) in 2001 and considered by the ACP (SC 11000. Consumer exposure to nonagricultural pesticides). Operator exposure models (Microsoft Excel spreadsheets) based on these values are available on the HSE website. Dermal exposure is expressed as mg/min of ready-to-use product. Dermal deposition rates relate to actual dermal exposure. Inhalation exposure is expressed as mg/m3 of ready-to-use product. The nominal density of the product is assumed to be 1.0 g/ml. Pre-pressurised aerosol cans. Model 1: space treatments Task monitored Intermittent discharge of a hand-held aerosol can into the air of a small sealed room (this event was repeated four times). The results (all based on strontium washings) represent the sum of 4 spraying events. The subjects remained in the room for 30 seconds after each event before exiting. The aerosol continuous discharge rate was 2.3 g/s. The predicted inhalation exposure depends on the dwell time within the area sprayed and careful judgement is required in the interpretation of both the measured airborne concentrations and the dermal exposure values. In practice, the dermal exposure probably occurs mainly during the period of spraying. The value of the inhalation component results from a 36 second exposure (6 second release + 30 second dwell time). Hand and forearmLegs, feet & face Inhaled Probability of exposure 100% 100% 100% 10 data 10 data 10 data Range of non-zero values 21.6 to 432 mg/min24.5 to 233 mg/min64 to 374 mg/m3 75th % value 156 mg/min 113 mg/min 234 mg/m3 Pre-pressurised aerosol cans. Model 2 : surface treatments Task monitored 1995 study: spraying a small room including a sofa, 6 metres of skirting board, 2 dining chairs and 6 m2 of carpet. Hand and forearm dermal measurements only were taken. 1998 study: spraying a living room containing a 3-piece suite, 6 m2 of carpet and a pet bed. Probability of exposure Range of non-zero values 75th % value Hand and forearm 100% 15 data Legs, feet & face 100% 6 data 1.7 to 156 mg/min 64.7 mg/min 17 to 45.2 mg/min 35.7 mg/min Inhaled 93% 15 data (1 = zero) 0.33 to 49.5 mg/m3 35.9 mg/m3 For this application scenario use the Aerosol Surface treatment model Hand-held trigger spray containers. Model : surface treatments Task monitored Hand-held trigger spraying 13 m of skirting board, 2 m2 of shelves and 8 m2 of horizontal and vertical laminate surfaces. The sprayer discharged up to 1.1 g of product per trigger pull. Note: hand muscles experience rapid fatigue after very few minutes’ use of these devices. The results were all based on strontium washings. Probability of exposure Range of non-zero values 75th % value Hand and forearm 100% 11 data 3 to 68.2 mg/min 36.1 mg/min Legs, feet & face 100% 11 data 1.9 to 12.4 mg/min 9.7 mg/min Inhaled 100% 11 data 2.6 to 19.5 mg/m3 10.5 mg/m3 For this application scenario use the Trigger spray surface treatment model c) Dustable Powder formulations Levels of operator exposure for non-professionals when using DP formulations packaged in puffer packs and GR/FG formulations packaged in shaker packs can be estimated on the basis of the following data published on the European Chemicals Bureau (TNsG / TNSG on Human Exposure / Report 2002 part 2 page 198). These data were generated by the Health and Safety Laboratory (HSL) in 2001 and considered by the ACP (SC 11000. Consumer exposure to non-agricultural pesticides). Dermal exposure is expressed as mg/min of ready-to-use product. Dermal deposition rates relate to actual dermal exposure. Inhalation exposure is expressed as mg/m3 of ready-to-use product. The nominal density of the product is assumed to be 1.0 g/ml. Hand-held dusting applicator pack for crack and crevice treatments Task monitored Crack and crevice powders for fleas and ants, indoor and outdoor use. The products were found to be particles of inert filler such as fine talc or chalk (median 45% of dust less than 75 µm) in a flexible canister with a single dispense hole with a diameter of 2 to 2.5 mm. A synthetic mixture with 5% Tinopal and 1% strontium reproduced the finest grade of powder found from six different products. Volunteers wearing minimal clothing applied dust in a simulated ant treatment in a kitchen, including 13 m of skirtings, 2 m2 of shelves and 3 m2 of horizontal laminate surfaces. Probability of exposure Range of nonzero values 75th % value Hand and forearm 100% Legs, feet & face* 100% Inhaled 10 data 0.4 to 4.18 mg/min 2.83 mg/min 10 data 0.22 to 6.56 mg/min 2.15 mg/min 10 data 0.21 to 8.01 mg/m3 1.78 mg/m3 100% For this application scenario use the Puffer pack model d) Granule application At present there is no available exposure model for predicting exposure for amateur users applying granules (i.e. via a shaker pack). In the absence of specific exposure data for granule products, the Puffer pack model for users applying dustable powder formulations via puffer packs could be used as surrogate data for this exposure scenario. (iv) Exposure assessment – Bystanders It is expected that exposure for bystanders will not exceed that predicted for persons applying the product. Therefore where an acceptable exposure scenario is determined for a user, levels of exposure for bystanders are expected to be within acceptable levels. (v) Exposure assessment – Children (spray applications) Please refer to the relevant sections of The European Food Safety Authority (EFSA) guidance document1 on the assessment of operator, worker and resident & bystander exposure to plant protection products vi) Exposure assessment – Children (granule applications) For products applied as granules there is a potential for these to be ingested by children who may enter treated areas soon after the granules after they have been applied. An example of how a risk assessment could be conducted for this scenario is given below. 'XXX PK' is a granular product containing 1% w/w active (c), for use as a soil pest killer in various vegetable crops. The product is to be applied at a maximum rate of 16g product per m2 (0.16 g active/ m2). Exposure to this product is calculated from the ingestion of soil by children, using the product label application rate recommendations. Active substance concentration in soil = 16 g/m2 (rate of application for product) × 1% a.s. (concentration of a.s. in product) × 100%/cm (100% of a.s. in top 1cm of soil) ×106 µg/g × m2/10000 cm2 (conversion factor) × 0.67 cm3/g (soil density) = 11 µg a.s./g soil. Exposure to the active substance via ingestion of soil is calculated for a child ingesting 200 mg soil ingested per day (mean value). This value is taken from the EPA’s Exposure Factors Handbook (page 431, Table 423). Children 11 µg a.s./g soil × 0.2 g/day (average daily soil ingestion rate) = 0.0022 mg/child/day. For a child of 15kg bw intake = 0.00014 mg/kg bw/day 1 Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products: EFSA Journal 2014;12(10):3874