Reducing workload by applying risk envelope approach to BPFs

Transcription

1 Reducing workload by applying risk envelope approach to BPFs An Vanden Bosch 6 th BPR symposium, 17 October, Brussels

2 introduction reducing complexity complex BPFs: high number of products & uses data generation: identify worst case product/use risk assessments: one risk assessment per product/use? rely on CAR? harmonize? group similar products / similar uses?

3 introduction strategy for grouping: meta SPC? product A similar composition within specified variations and considering the formulation type; same shelf life/c&l product family meta SPC 1 meta SPC 2 product B product C product D product E similar use, i.e. uses within certain PT(s) that may cover e.g. prof/private use, indoor/outdoor use, different target organisms, different application methods/doses/frequencies! dependent on efficacy and risk assessments meta SPC 3 product F product G factors determining meta SPC structure parameters driving the risk assessments different areas of risk assessment require different grouping

4 introduction strategy for grouping: risk envelope? 1 inventarisation of uses 2 define key parameters that drive the risk assessment 3 group uses according to these parameters 4 5 define a critical use that represents a worst case use for all other uses in that group risk for worst- case use acceptable => all other uses in the group can be considered safe uses 6 it may be possible to identify a 'worst- case group' that covers the other groups

5 introduction ongoing developments A proposal for an environmental risk envelope approach to assess product families and Union authorisation under the Biocidal Products Regulation Simón Gutiérrez Alonso, Heike Schimmelpfennig, Jaana Laitinen, Adriana Lipkova, Eugénia Nogueiro, Jan Weber, Peter Okkerman, Stéphanie Alexandre, Béatrice Chion Optimising Environmental Risk Assessment in a large Biocidal Product Consortium Tineke De Wilde, Bram Peeters, Leen Jansen, Sabine Navis, An Ghekiere, Frederik Verdonck SETAC Brussels, May 2017

6 case study: environmental risk assessment for disinfectants disinfection of hands, hard surfaces, swimming pools, animal housing, hooves, breweries, drinking water, case : ERA environmental exposure risk = exposure toxicity source: EPA

7 estimating exposure case : ERA

8 case : ERA parameters driving exposure parameters concentration of a.s. in product (g/l or g/kg) amount of product per event (ml or g) events per day (1/d) fraction released to wastewater market share of the disinfectant (a.s.) emission to wastewater (kg/d)

9 case : ERA grouping products conc. a.s. (g(g/l) a.s./l) amount of product per application (ml) number events per of applications day (1/d) per day (1/d) application rate (g a.s./d) product A product B product C product A meta SPC 1 product B product C product family meta SPC 2 product D product E meta SPC 3 product F product G

10 case : ERA grouping uses PT Use: disinfection of Exposure formula 1 hands (medical use) A x E x F x U 1 hand (general use) C x A x E x F x S x U 2 hard surfaces (industrial use) C x A x V x E x F x U 2 room (fogging) C x A x V x E x F x U 2 public swimming pools chronic exposure C x V x E x F x U C = Concentration A = Application rate V = Treated surface or volume E = Events per day F = Fraction to STP S = Market share U = Unit conversion to kg/d 3 animal housing C x A x V x F x U 3 hooves C x V x E x F x U 4 hard surfaces (slaughter house) C x A x V x E x F x U 4 breweries (CIP) A x E x F x U 5 drinking water C x V x E x F x U meta SPC 1 product A product B product C product family meta SPC 2 product D product E C x A x V x E x F x S x U meta SPC 3 product F product G

11 case : ERA calculating environmental exposure PT Use: disinfection of Concentrat ion (C) Application rate (A) Treated surface or volume (V) Events per day (E) Fraction to STP (F) Market share (S) Unit conversion (U) 1 hands (medical use) / 0.1 g a.s./d / 400/d 1 / hand (general use) 2% 0.02 L/d / 2000/d hard surfaces (industrial use) 15% 0.1 L/m m 2 1/d 1 / room (fogging) 5% 80 ml/m m 3 1/d 1 / public swimming pools chronic exposure Emission to ww (kg/d) 8% / 50L 400/d 1 / animal housing 10% 0.3 L/m m 2 / 1 / hooves 14% / 675 L 2/d 0.9 / hard surfaces (slaughter house) highest emission to wastewater 15% 0.1 L/m m 2 1/d 0.1 / breweries (CIP) / 228 kg a.s./y / 0.004/d 1 / drinking water % / L 1/d 1 / C x A x V x E x F x S x U

12 case : ERA MAD e concept air acceptable risk for the environment? surface water highest emission to wastewater STP groundwater maximum allowed dosage for the environment that would not cause any risk in any environmental compartment (PEC/PNEC < 1) soil

13 case : ERA considerations based on case study ERA Advantages strong reduction in complexity similar assessment for SoCs easy to add uses to BPF later in the process of dossier compilation possible to reversely calculate the max. allowable application rate or concentration of a.s. in product once MAD e is calculated for a substance, applicants can formulate any product within the product family that does not exceed MAD e Question marks acceptance by regulators? how to present risk envelope and MAD e derivation in the PAR? procedure to add uses to BPF after product authorisation? 80/20 rule: approach cannot always be applied, e.g. if refinements are required emission does not pass STP aggregated exposure?

14 case : HHRA case study: human health risk assessment in principle, the risk envelope approach can be applied different routes of exposure (oral, dermal, inhalation) local vs. systemic exposure different exposure scenarios (M&L, different application techniques, child/adult, ) combined scenarios grouping of similar products is feasible less benefit expected than for ERA (20/80) internal dose

15 conclusion summary Demonstrating safe use for complex BPFs can be challenging due to the high number of products and uses There is scope for reducing workload by applying the risk envelope approach, a concept routinely used in plant protection product dossiers. This can be achieved by grouping risk assessments for different products within a meta SPC for different uses across meta SPCs Defining a MAD e can be an asset, as it allows easy addition of products/uses to the BPF Exact setup and presentation in the dossier to be discussed with competent authorities Both applicants and regulators can benefit from this approach

16 Thank you for your attention Special thanks to my colleagues