Practical examples on active substance risk assessment: Fungicides. Info Session on Aquatic Guidance 6/7 November 2013
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1 Practical examples on active substance risk assessment: Fungicides Theo Brock, Alterra, Wageningen UR (PPR Panel Member) Info Session on Aquatic Guidance 6/7 November
2 Practical examples Aim to illustrate the most important items of the guidance provided in the new AGD Focus of this presentation on: Fungicides Tiered approach in effect assessment Linking exposure to effects 2
3 Practical examples Fungicide F A case study (Appendix H.2) Anilinopyrimidine Inhibitor of methionine biosynthesis Use in winter wheat 1 application in spring (0.75 kg/ha) FOCUS Step 3 calculations 3
4 Typical exposure profiles for F A (FOCUS sw) Step 3 PEC sw;max : μg/l 4
5 Tier 1 effect assessment Acute L(E)C 50 (µg as/l) a.s./l) Chronic EC x /NOEC (µg as/l) a.s./l) Americamysis bahia 18.2 (96 h) - Daphnia magna 33 (48 h) 7.5 (21 d NOEC) Chironomus riparius (48 h) 140 (28 d EC 10 ) Oncorhynchus c mykiss (96 h) - Pimephales promelas (36 d NOEC) Scenedesmus subspicatus (72 h E r C 50 ) AF of 100 to the lowest acute toxicity value (18.2 μg/l) Tier 1 RAC sw;ac = μg/l AF of 10 to the lowest chronic toxicity value (7.5 μg/l). Tier 1 RAC sw;ch = 0.75 μg/l 5
6 Tier 2A effect assessment Acute L(E)C 50 Chronic Taxonomy (µg a.s./l) EC 10 /NOEC Americamysis bahia 18.2 Crustacea Daphnia magna (repro) Crustacea Daphnia longispina 120 Crustacea Ceriodaphnia dubia 150 Crustacea Asellus aquaticus (mort.) Crustacea Mesocyclops leuckarti 220 Crustacea Halella azteca 980 Crustacea Thamnocephalus plat Crustacea Geomean Crustacea Chironomus riparius Insecta Chaoborus sp Insecta Cloeon dipterum Insecta Crassostrea virginia 758 Bivalvia Lymnaea stagnalis Gastropoda Scenedesmus subspicatus Green alga Pseudokirchneriella subcap Green alga Navicula pelliculosa Diatom Anabaena flos-aquae Blue-green alga Lemna gibba Vascular plant Geom-RAC sw;ac of μg/l (crustaceans and AF of 100) 6
7 Tier 2B effect assessment SSD approach is possible on basis of acute toxicity data only N Median HC5 LL HC5 Goodness-of-fit (µg a.s./l) (µg a.s./l) SSD curve All taxa (incl. fish) No All taxa (excl. fish) No Invertebrates Yes Crustaceans Yes SSD curve for invertebrates is selected AF of 3 6 has to be applied to median HC5 7
8 Tier 2B acute effect assessment 1. The lower limit value of the HC5 2. Tier 1 & Tier 2A RACs not in conflict with AF 6 3. Crustacean toxicity data in lower tail SSD 4. Steepness of the SSD curve 5. Chronic effects (Acute/chronic ratio >10) AF of f6i is selected SSD-RAC sw;ac = 3.84 μg/l 8
9 Preliminary risk assessment (potential risks in most scenarios) 9 Tier 1 RAC sw;ch Tier 2B RAC sw;ac
10 Tier 3 effect assessment Lentic mesocosm study (GLP; R1-2) Repeated application (3x; weekly) of fungicide F A (nominal μg/l) Dissipation i i DT50 = 9-11 days (realistic i to worst case exposure relative to field More than 8 taxa of potentially sensitive group (including 8 crustacean) See summary Table H.11 on page ETO-RAC sw;ac & ETO-RAC sw;ch = 3.03 μg/l (Effect class 2 and AF of 3; Ri-2 study) ERO-RACRAC sw;ac & ERO-RACRAC sw;ch = μg/l (Effect class 3A and AF of 4; Ri-2 study) 10
11 Summary F A : Risks acceptable on basis of recovery option only Threshold option Recovery option Scenario PEC sw;max (µg/l) ETO-RAC sw;ac ETO-RAC sw;ch (µg/l) PEC sw;max (µg/l) ERO-RAC sw;ac ERO-RAC sw;ch (µg/l) D1 Ditch D1 Stream D2 Ditch D2 Stream D3 Ditch D4 Pond D4 Stream D5 Pond D5 Stream D6 Ditch R1 Pond (Tier 1) (Tier 1) R1 Stream R3 Stream R4 Stream
12 Case study: Fungicide Fun 2 Dutch exposure scenario standard ditch (use in potatoes) 50% drift red.: PEC max = μg/l; PEC 7d-twa = μg/l; PEC 7d-twa = μg/l 95% drift red.: PEC max = μg/l ; PEC 7d-twa = μg/l 12
13 Tier 1: Fun 2 Acute (μg/l) Chronic (μg/l) Daphnia magna 94 (48 h EC 50 ) 8.5 (21 d NOEC) Chironomus riparius 1995 (96 h LC 50 ) - Oncorhynchus h mykiss 63 (96 h LC 50 ) 29( dnoec) Scenedesmus subspicatus (72 h E r C 50 ) AF of 100 to the lowest acute toxicity value (63 μg/l) ) Tier 1 RAC sw;ac = 0.63 μg/l AF of 10 to the lowest chronic toxicity value (2.9 μg/l). Tier 1 RAC sw;ch = 0.29 μg/l 13
14 Preliminary risk assessment Fun 2 Negligible risks for 95% drift reduction only 14
15 Tier 2 Effect assessment fish (Fun 2 ) Fish Acute LC 50 (μg/l) Chronic NOEC (μg/l) Oncorhynchus mykiss (growth) Pimephales promelas (growth) Lepomis macrochirus (growth) Danio rerio 120 Cyprinodon variegatus 89 Cyprinus carpio 150 Geomean (AF of 100) 6.99 (AF of 10) Geom-RAC sw Median HC (AF of 9) SSD-RAC sw 5.19 SSD-RAC sw;ac > PEC sw;max (1.24 μg/l) acute risk low Geom-RAC sw;ch < PEC sw;max (1.24 μg/l) ) potential chronic risk Geom-RAC sw;ch > PEC sw;7d-twa (0.087 μg/l) low chronic risk (TWA approach according to criteria section AGD) 15
16 Is higher tier RAC for fish and Fun 2 protective for non-vertebrates? Acute (μg/l) Chronic (μg/l) Higher tier RAC fish 5.19 (SSD RAC) (Geom RAC) Daphnia magna 94 (48 h EC 50 ) (21dNOEC) 0.94 (Tier 1 RAC) 0.85 (Tier 1 RAC) Scenedesmus subspicatus (72 h E r C 50 ) (Tier 1 RAC) Potential acute risks for invertebrates (not covered by SSD-RAC of 5.19 μg/l for fish and PEC sw;max of 1.24 μg/l) 16
17 Taxonomic group Acute L(E)C 50 (μg/l) Daphnia magna Crustacea 94 Gammarus pulex Crustacea 79.1 Asellus aquaticus Crustacea 129,4 Chironomus riparius Insecta 1995 Cloeon dipterum Insecta Lymnaea stagnalis Mollusca Dugesia lugubris Turbellaria 23.8 Lumbriculus variegatus Oligochaeta 15.7 Toxicity data for 5 different taxonomical groups Geomean approach less applicable (for several taxonomical groups 1 species tested t only) SSD approach possible (8 taxa tested) 17
18 Tier 2B for invertebrates (FUN 2 ) Median HC 5 = μg/l; LL HC 5 = μg/l AF of 3 6 has to be applied to median HC 5 SSD-RAC sw;ac = μg/l SSD-RAC sw;ac > PEC sw;max (1.24 μg/l) acute risk acceptable for invertebrates 18
19 Risk due to secondary poisoning (FUN 2 ) Log P OW = 4 BCF = 1023 NOAEL bird = 500 mg/kg diet NOAEL mammel = 10 mg/kg diet RAC SP = NOAELbird NOAEL or BCFfish BMF BCFfish mammal BMF RAC sp = 615 μg/l (bird) or 14 μg/l (mammal) RAC sp of 14 μg/l > PEC sw;21d-twa of μg/l (low risks due to secondary poisoning for 50% drift 19 reduction exposure scenario)
20 Thank you! Info Session on Aquatic Guidance 6/7 November
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