Case study 5: Risk assessment for in soil organisms: future approaches and perspective

Transcription

1 Case study 5: Risk assessment for in soil organisms: future approaches and perspective Maria Arena Pesticides Unit, EFSA Topical Scientific Workshop on Soil Risk Assessment ECHA, Helsinki, 7-8 October 2015

2 SUBSTANCE PROPERTIES I AD (anthranilic diamide insecticide) is efficacious for control of lepidopteran insect pests, as well as some species in the orders Coleoptera, Diptera and Hemiptera through impairment in the regulation of muscles contraction. Function Partition Coefficient Dissociation constant Insecticide 20 C ph 4:2.77 ph 7:2.86 ph 9: High to very high persistence-dt 90lab-f >1 y 2

3 REPRESENTATIVE USES Crop Country F or G or I Pest or group of pests controlled Pome fruits NEU SEU F Cydia polmonella Leafminers Leafrollers Opherophtera brumata Stone fruits SEU F Cydia molesta Anarsia lineatellata Wine grapes Table grapes Fruiting vegetables NEU SEU F L.botrana E.ambiguella SEU F L.botrana E.ambiguella SEU F S.littoralis H.armigera S.exigua P.gamma Lettuce SEU F S.exigua S.littoralis H.armigera Growth stage BBCH 70- BBCH 87 BBCH 73- BBCH 85 BBCH 57- BBCH 83 BBCH 57- BBCH 85 BBCH 71- BBCH 89 BBCH 12- BBCH 49 Number of appl. Interval between appl. Appl. rate (g a.s./ha) (300 ml fp/ha) (300 ml fp/ha) 1 n.a. 54 (270 ml fp/ha) (216 ml fp/ha) ( g fp/ha) ( g fp/ha) 3

4 EXPOSURE-CURRENT APPROACH (PARENT COMPOUND) Crop Parameter Value Units Appl. rate (g a.s./ha) Interval Crop intereception FOCUS (%) PEC max (mg/kg) Soil depth 5 Pome fruit cm 2x Soil dry bulk density Molecular weight Intereception Worst case DegT Stone fruits g/cm 3 2x Grapes, wine g/mol Grapes, - FOCUS table 1x x ,378 Lettuce d 2x Fruiting vegetables 2x

5 Case study 5 EXPOSURE-PERSAM-EFSA GD 2015 (PARENT COMPOUND) Crop Appl. Interval Fsoil PEC max Parameter Value Units rate (g (mg/kg) a.s./ha) Soil depth cm Pome fruit 2x60 14 Soil dry bulk 1.51 g/cm Stone 2x density (South-only fruits at Tier 1) Grapes, 1x54 - Molecular g/mol wine weight Fsoil - Grapes, - 2x table Geometric mean DegT Lettuce d 2x Fruiting vegetables 2x

6 PERTINENT SOIL METABOLITES Metabolite Partition coefficient Persistence Max PEC soil Lettuce 2x42 g a.s./ha (25+40% interception) App. Interval=7d Max PEC soil Pome fruits/stone fruits 2x60 g a.s./ha (70% interception) App. interval=10d Metabolite , Metabolite , Metabolite Metabolite , PEC soil (worst case)-persam 6

7 TOXICITY DATA ON SOIL ORGANISMS Test organisms Test substance Time scale Endpoint Earthworms Eisenia fetida Active Acute 14 days LC50>1000 mg a.s./kg d.w. soil Eisenia fetida Formulation1 Acute 14 days LC50>1000 mg product/kg d.w. soil (>200 a.s.) Eisenia fetida Formulation2 Acute 14 days LC50>1000 mg product/kg d.w. soil (>350 a.s.) Eisenia fetida Formulation2, 56 days NOEC=1000 mg product/kg d.w. soil (350 a.s.) 7

8 TOXICITY DATA Test organisms Test substance Other soil macro-organisms Folsomia candida Hyapoaspis aculeifer Time scale Endpoint Active 28 days NOEC=0.39 mg a.s./kg d.w. soil Active 16 days NOEC=100 mg a.s./kg d.w. soil Test organisms Test substance Time scale Endpoint Data on adsorption/desorption Microorganisms in several soils suggested that sorption is not greater in the artificial soil Nitrogen compared and to natural soils. Consequently, I AD is expected to exhibit similar Carbon bioavailability in natural and artificial soils. Therefore the factor of mineralisation 2, as suggested by the SANCO GD on terrestrial ecotoxicology for lipophilic Nitrogen substances, and was reasonably not applied to the toxicity endpoint. Carbon mineralisation Nitrogen and Carbon mineralisation Active 28 days <25% effects at mg a.s./kg d.w. soil Formulation1 42 days <25% effects at mg product/kg d.w. soil Formulation2 42 days <25% effects at mg product/kg d.w. soil 8

9 RISK CHARACTERISATION Test organisms Time scale Endpoint Eisenia fetida Acute LC50>1000 mg a.s./kg d.w. soil Eisenia fetida NOEC=1000 mg product/kg d.w. soil (350 a.s.) PEC (worst casecurrent approach) PEC (new approach- EFSA GD 2015) TER >2273/> /1785 Hyapoaspis aculeifer NOEC=100 mg a.s./kg d.w. soil /178 According to the trigger as defined in the Reg.546/2011 low risk to earthworms and mites for all the representative uses 9

10 RISK CHARACTERISATION Crop Test organisms Time scale Endpoint PEC (current approach ) PEC (new appraoch- EFSA GD 2015) TER Lettuce Folsomia candida NOEC=0.39 mg a.s./kg d.w. soil /0.76 Pome fruits/stone fruits Folsomia candida NOEC=0.39 mg a.s./kg d.w. soil Grapes, table Folsomia candida NOEC=0.39 mg a.s./kg d.w. soil Grapes, wine Folsomia candida NOEC=0.39 mg a.s./kg d.w. soil Fruiting vegetables Folsomia candida NOEC=0.39 mg a.s./kg d.w. soil /0.7 According to the trigger as defined in the Reg.546/2011 high risk to Collembola for all the representative uses 10

11 RISK CHARACTERISATION-METABOLITES Test organisms Time scale Endpoint PECsoil (worst case) PECsoil (worst case)-persam TER Metabolite 1 Metabolite 2 Eisenia fetida Eisenia fetida Acute (56d) Acute (56d) LC50>1000 mg met/kg d.w. soil NOEC=1000 mg met/kg d.w. LC50>1000 mg met/kg d.w. soil (350 a.s.) NOEC=1000 mg met/kg d.w. Metabolite 3 Eisenia fetida Acute LC50=632.5 mg met/kg d.w. soil Metabolite 4 Eisenia fetida Acute (56d) LC50>1000 mg met/kg d.w. soil NOEC=1000 mg met/kg d.w >3703/> / >4785> / / >1351/> /446 According to the trigger as defined in the Reg.546/2011 low risk to earthworms identified for the pertinent soil metabolites 11

12 Metabolite 1 RISK CHARACTERISATION-METABOLITES Test organisms Folsomia candida Time scale (28 d) Endpoint NOEC=100 mg met/kg d.w. PECsoil (worst case) PECsoil (worst case) PERSAM According to the trigger as defined in the Reg.546/2011 low risk to soil invertebrates other than earthworms and soil microorganisms was identified for the pertinent soil metabolites TER /159 Folsomia NOEC=100 mg /2.08 Metabolite 2 Test candida organisms Test (28 d) substance met/kg Time d.w. scale Endpoint Metabolite 3 Folsomia candida Microorganisms Nitrogen and Carbon Folsomia Metabolite 4 mineralisation candida Nitrogen and Carbon mineralisation Nitrogen and Carbon mineralisation (28 d) LC50=100 mg met/kg d.w. soil /1333 Metabolite1 28 days <25% effects at NOEC=100 mg mg met/kg (28 d) met/kg d.w. d.w. soil /45 Metabolite2 28 days <25% effects at mg met/kg d.w. soil Metabolite3 28 days <25% effects at mg met/kg d.w. soil 12

13 HIGHER TIER TESTINGS Case Study 5 2 litter bag studies available 1. The study was conducted using Formulation1 and no effects were seen on degradability of soil organic matter in 12 months under exposure conditions simulating 10 years continual use at annual rate of 150 g a.s./ha 2. The study was conducted using Formulation2 and metabolites and no effects were seen on degradability of soil organic matter in 17 months simulating 10 years continual use at annual rate of 240 g a.s./ha 13

14 CURRENT APPROACH High risk for Collembola Structural endpoint Litter bag studies Functional endpoint LogPow>2? Applying a factor of 2 to the toxicity endpoint if the test is carried out by using an OECD soil with 10 % or 5% sphagnum peat Are the standard test species sensitive enough to protect the soil ecosystem (biodiversity and functions)? 14

15 FUTURE PROSPECTIVE Need for clear SPGs Functional diversity vs Genetic diversity? Structural or Functional? Bioavailability Bioavailability of the test item in the test systems (e.g. lipophilic substances) 15

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