Regulatory Risk Assessment of Crop Protection Products
|
|
- Jerome Norman
- 6 years ago
- Views:
Transcription
1 Regulatory Risk Assessment of Crop Protection Products Risk Assessment for Residues in Food and Environment Georg Geisler Regulatory Policy Manager Global Registration Syngenta Crop Protection AG, Basel
2 Regulatory Risk Assessment of Crop Protection Products Todays topics Principles of regulatory risk assessment How does CPP regulation work? Foundations of risk assessment: Studies Case studies: Dietary exposure; Environmental fate Wrap-up/Job perspectives 2
3 Safety for Humans and Environment No unacceptable effects on environment No harmful effect on human health Regulation (EC) No. 1107/2009 (main points of preamble summarised) Syngenta ensures the quality and safety of its products Risk assessment needed The Syngenta Code of Conduct, Section 19 3
4 Principle of Risk Assessment Risk depends on exposure to a hazard Low exposure Low hazard Low risk High exposure High hazard High risk 4
5 What Advice Helps You Best to Plan a Healthy Diet? - Hazard vs. Risk no evidence that pesticide thresholds had been exceeded The potential lifelong damage of pesticides is estimated to be only 4.2 and 3.2 min of life lost per person in Switzerland and the United States, respectively R. Juraske et al. / Chemosphere 77 (2009)
6 Principle of Risk Assessment (2) (Eco-)Toxicological studies Consumption data (Food) Residue studies (Crops or soil) Hazard (Reference doses) Exposure (Residue level) Risk Assessment 6
7 Exposure pathways Application Emission Concentration in different compartments Safeguard subjects 7
8 Processes Process type Process Cause Degradation Bio-degradation Fungi, bacteria, plants, etc. Munch, munch Hydrolysis ph Photolysis Sunlight Sorption Reversible ad/desorption Soil organic matter, clay (ionic substances) O OH O O O Aging of sorption Diffusion into pores (soil) O OH O Bound residues Incorporation into natural soil/plant constituents O O Transport Translocation Water/air fluxes (soil, water bodies, plants, etc.) Dilution Accumulation Mixing during translocation Soil; oil/fat matrices 8
9 Time Scale: Acute vs. Chronic Risk Assessment Acute Chronic Concentration at emission Acute effects Time-weighted average concentration Chronic effects 9
10 Calculation: Deterministic Risk Assessment Risk quotient: RQ = PEC PNEC (Realistic) worstcase scenario Lowest NOEC x Safety factor RQ 1 RQ > 1 => No unacceptable risk to ecosystem => Potential risk to ecosystem, need more realistic assessment PEC PNEC NOEC Predicted environmental concentration (concentration endpoint) Predicted no-effect concentration (ecotoxicity endpoint) No observed effect concentration from ecotoxicological study For risk assessment of crop protection products, each representative species is assessed separately 10
11 Calculation (2): Probabilistic Distribution Risk quotient: RQ = PEC Ecotox. endpoint Distribution Probability density Deterministic ecotox. endpoint PEC ecotox. endpoint distribution Concentration 11
12 Consumer Risk Assessment: What Scenario? Exposure pathway Processes Time scale Calculation Exposure endpoint Hazard endpoint 12
13 Consumer: Chronic vs. Acute Risk Assessment 0.3 ppm Chronic 0.08 ppm 0.05 ppm Acute Lifelong Long-term average consumption (all food) 1 day/1 meal Large portion consumption (one food) Population groups, e.g. adults, children Average residue level from worst-case crop field trials (STMR) Sum exposure for all food Toxicological reference dose: Acceptable Daily Intake (ADI) Highest residue level from worst-case crop field trials (HR) Exposure per food item Toxicological reference dose: Acute Reference Dose (ARfD) 13
14 Deterministic Risk Assessment: Consumer (chronic) (Inter-)national databases Crop field trials Intake = S Consumption i * STMR i ADI * 100% NOAEL * Safety factor Intake < 100% of ADI => No unacceptable risk to consumer Intake < 100% of ADI => Potential consumer risk, need more realistic assessment Consumption STMR ADI NOAEL Amount of food consumed (part of exposure endpoint) Supervised trial mean residue level (part of exposure endpoint) Acceptable daily intake (human toxicity endpoint) No observed adverse effect level 14
15 Regulatory Risk Assessment of Crop Protection Products Todays topics Principles of regulatory risk assessment How does CPP regulation work? Foundations of risk assessment: Studies Case studies: Environmental fate; Dietary exposure Wrap-up/Job perspectives 15
16 Example: pesticides Regulatory procedure Time, years 0 Dossier Manufacturer Evaluation, requirements Authorites Further modelling/ testing/ assessment > 5 Approval (Mitigation) (Restrictions) 16
17 Regulatory testing/modelling: Tiered approach Cost, time Higher tier Tailor-made tests / modelling Tier 2 Advanced tests / modelling Tier 1 Basic standardised tests / modelling 17
18 Regulatory Risk Assessment of Crop Protection Products Todays topics Principles of regulatory risk assessment How does CPP regulation work? Foundations of risk assessment: Studies Case studies: Environmental fate; Dietary exposure Wrap-up/Job perspectives 18
19 Studies: Types and Sequence What? Metabolism studies Compounds relevant to consumer/environmental safety Plant metabolism Soil metabolism How much of it? Magnitude-ofresidue studies Crop field trials Soil degradation Risk assessment Study protocols defined by OECD Test Guidelines: v/periodical/p15_about.htm?jnlissn= x 19
20 Metabolism: Plants Representative crops Worst-case treatment ( 14 C) Sampling Elucidate metabolism Source: Codex Evaluation
21 Soil Degradation: Tiered Experimental Approach Realism, cost Interpretability, generalizability Testing tier Test method Monitoring Field accumulation Field studies Field degradation Semi-field Lysimeter Laboratory OECD standard test Estimation QSAR 21
22 Studies: Laboratory Degradation Experimental: OECD 307 Aerate Snore, snore Extract/ analyse m applied Apply c extractable (t 1 ) Mix Traps c bound (t 1 ) c extractable (t 2 ) c bound (t 2 ) Mmm, tasty! Munch, munch c extractable (t 3 ) c bound (t 3 ) 22 Balance: CO 2 Volatile compounds c extracted c bound Target: % of m applied
23 Concentration, % of applied Substance Properties: Fitting degradation half-life (DT50) First-order kinetics: Co-metabolism Degradation rate: dc k c dt c c exp t 0 k t Half-life: DT50 ln2 k Fitting results: c 95.2 exp t 60 Rate constant (k) En guete! Time, days 23
24 Concentration, µg/kg Substance Properties: Metabolites Parallel degradation reactions: Parent f (1-f) Metabolite CO Degradation rates: dc parent dt dc dt metab k f k parent parent c c parent parent k metab c metab Parent Metabolite Time, days 24
25 Concentration, mg/kg Degradation half-lives: Tiered Testing Laboratory test: Microbial viability decreases with time Laboratory degradation often slower than field Degradation rate decreases over time => Non-SFO kinetics (e.g. bi-phasic) Bi-phasic (FOMC) First-order Time, days Field degradation studies give a more realistic picture! 25
26 Regulatory Risk Assessment of Crop Protection Products Todays topics Principles of regulatory risk assessment How does CPP regulation work? Foundations of risk assessment: Studies Case studies: Environmental fate; Dietary exposure Wrap-up/Job perspectives 26
27 Case study: Dietary exposure of consumers 27
28 Consumption Data: GEMS/food Cluster Diets (WHO/FAO) 28
29 Chronic Consumer Risk Assessment Total Maximum Daily Intake (TMDI): TMDI = S MRL i * Consumption i / bw International Estimated Daily Intake (IEDI): IEDI = S STMR i * Consumption i / bw MRL Maximum residue level, mg/kg STMR Supervised trials mean residue level, mg/kg Consumption, kg/person i commodity (plant or animal) bw body weight, kg ADI Acceptable daily intake, mg/kg bw/day Risk: expressed as % of ADI TMDI, IEDI overestimations: MRL is maximum residue (95th percentile); STMR is mean residue, but from worst-case field trials => EU official monitoring: residues in food mostly << STMR Assumes 100% crop treated No dissipation during storage/processing GEMS/Food consumption data overestimates actual consumption 29
30 Chronic Consumer Risk Assessment ADI = mg/kg bw/day Used in citrus, apple, grapes, tomato, maize Body weight: 60 kg/person GEMS/food consumption data (Cluster B = Mediterranean) and calculation methods of WHO/FAO Food Consumption, kg/person/day MRL (maximum), mg/kg TMDI, µg/person/ day STMR (mean), mg/kg IEDI, µg/person/ day Citrus fruit Apple Grape (incl. wine) Tomato Maize Total intake = %ADI = 100.2% 44% 30
31 Realistic exposure: EU official monitoring 2009, : 97.2% No chronic dietary risk Acute dietary risk for <= 0.4% of samples Multiple resdiues ca. 1/4 of samples (citrus, grape, strawberry, pepper) 2010: 50.7% of samples no quantifiable residues EU Report on Pesticide Residues. EFSA Journal 2011; 9(11): EU Report on Pesticide Residues. EFSA Journal 2013; 11(3):
32 Realistic exposure: Cumulative dietary risk assessment Scope: - Cumulation: residues of several compounds in all food commodities - Aggregation: food + drinking water (+ other pathways) Method/data: - Exposure: Consumption; realistic residue levels; co-occurrence - Hazard: Common assessment groups (common mode of toxic action; common target organ) EU: Method development ongoing - Major challenge: «Common Assessment Groups» no assessment of actual cumulative exposure conducted so far has indicated any significant risks from exposure to multiple chemicals belonging to a CAG where the individual compounds presented no unacceptable risks EFSA Journal (2008) 704, p. 57 US: No additional risk compared to individual assessments - Organophosphates; N-methyl carbamates; Chloroacetanilides; Pyrethroids 32
33 Case study: Environment 33
34 Predicted Environmental Concentrations: Pathways Spray application Interception Spray drift Volatilisation Deposition Runoff Field soil Leaching Drainage Surface water 34 Groundwater
35 Tier-1 Model (EXPOSIT): Drainage Application rate PECsw ini (drainage) M substance V drainage water Soil concentration (3 days after application) Ditch of 40 m 3 (baseflow + drainage water) Drainage loss: fraction of soil residue 35
36 Tier-1 Model (EXPOSIT): Drainage PECsw PECsw ini ini (drainage) (drainage) M M substance,drainage V water substance,soil V (t) A waterbody f field f dilution drainage Parameter M substance,soil Definition Mass of substance in soil, kg/ha 3 days after application, first-order kinetics Modeller choices Degradation half-life (time horizon) f drainage Fraction of pesticide lost by drainage Default values (season of application; adsorption) Appropriate default value V waterbody Volume of waterbody Worst-case ditch: default volumes (season of application) None f 36 dilution Default dilution factor of 2, flowing ditch None
37 Tier-1 Model: Soil Concentration M subs tan ce,soil (t) apprate k t 1 f e int erception PECsw ini (drainage) apprate 1 f int erception V waterbody e f k t dilution A field f drainage Parameter f interception Definition Fraction of application rate intercepted by the crop (i.e., not reaching soil) Modeller choices Default values according to growth stage of crop k Degradation rate (first-order kinetics), d -1 Appropriate value t 37 Time, d Default: 3 days
38 Case Study Herbistrike 10 : Soil Degradation Half-Lives Laboratory degradation studies Field degradation studies Soil type Half-life, days Location Half-life, days sandy clay 5.4 Germany loamy sand 9.9 Germany sandy loam 12.0 Northern France loam 56.0 Northern France clay loam Southern France clay loam Southern France Italy Italy Italy Maximum 56.0 Maximum th percentile th percentile 20.0 Geometric mean 12.9 Geometric mean 9.6 Arithmetic mean 17.7 Arithmetic mean 12.6 Median 11.4 Median 9.6 All half-lives following first-order kinetics 38
39 Case Study Herbistrike 10 : Tier-1 Evaluation Spray drift: Mitigation (10 m buffer zone) Drainage: Tier-1 model simplified worst-case Higher-tier drainage model (water body, weather data, application season) Buffer width, m fdrift, % PECsw,ini(drift), g/l RQ (incl. SF) fail fail pass! fdrainage, PECsw,ini(drainage), % g/l Fail!!! 39
40 Higher-Tier Model: FOCUS Surface Water ~ 90th percentile vulnerability => Realistic worst-case D1 D2 D5 D3 R1 D4 R2 R4 R3 D6 40
41 FOCUS Surface Water: Coverage 41
42 FOCUS Surface Water: Models Application rate Spray drift (SWASH) Runoff (PRZM) Drainage loss (MACRO) Surface water (TOXSWA) 42
43 FOCUS Surface Water: Water Body Types Ditch, Pond, Stream Drainage and/or runoff Runoff (water + sediment) from 20 m zone Water baseflow + runoff volume Pond (drift, runoff) 0.45 ha Ditch (drift, drainage, runoff) Stream (drift, runoff) 2 ha untreated 100 ha upstream catchment, 20% treated 100 m 43 1 ha treated 100 m 1 ha treated
44 Case-study Herbistrike 10 : PECsw with FOCUS Skousbo (D4): Stream with drainage Vreedepeel (D3): Ditch with drainage Spray drift entry Weiherbach (R1): Stream with runoff Weiherbach (R1): Pond with runoff Runoff entry 44
45 Happy end for everybody! Spray drift ok at tier-1, using mitigation (buffer zone) Drainage shown to be negligible at higher tier => Assessment passed 45
46 Regulatory Risk Assessment of Crop Protection Products Todays topics Principles of regulatory risk assessment How does CPP regulation work? Foundations of risk assessment: Studies Case studies: Environmental fate; Dietary exposure Wrap-up/Job perspectives 46
47 O O O O Risk Assessment: Wrap-up Risk vs. hazard Application Relevant exposure pathways, processes Munch, munch OH Sound underlying data (studies/monitoring) Tiered approach (studies, assessment) Mitigation 47 Buffer width, m fdrift, % PECsw,ini(drift), g/l RQ (incl. SF) fail fail pass! fdrainage, PECsw,ini(drainage), % g/l Fail!!!
48 Environmental Risk Assessment: Jobs 1. Employers Plant protection industry Chemical industry Pharmaceutical industry Contract Research (CRO) Authorities (national/eu) Academia/Research 2. Job profiles Study Director Expert Regulatory Affairs 48
49 Danke schön! Thank you! 49
Generic guidance for FOCUS surface water Scenarios
Version: 1.4 Date: May 215 Generic guidance for FOCUS surface water Scenarios About this document The report on which this document is based is that of the FOCUS Surface water Scenarios workgroup, which
More informationNational exposure assessment for the authorization of plant protection products (PPP) in Austria:
National exposure assessment for the authorization of plant protection products (PPP) in Austria: Calculation of predicted environmental concentrations (PEC) in soil, groundwater, surface water, sediment
More informationAssessment of the entry of PPP in groundwater in Germany
Assessment of the entry of PPP in groundwater in Karin Aden Chemistry Division, Braunschweig, Wolfgang Koch Federal Environmental Agency (UBA) Berlin, Aden 1 Entry routes of PPP in groundwater leaching
More informationPest Management Regulatory Agency: Aquatic exposure modelling for exposure assessment in support of the regulation of pest control products in Canada
Pest Management Regulatory Agency: Aquatic exposure modelling for exposure assessment in support of the regulation of pest control products in Canada 242nd ACS National Meeting August 28, 2011 Greg Malis,
More informationPlant uptake studies for refining chemical exposure assessments
Plant uptake studies for refining chemical exposure assessments Original thinking supporting chemical exposure assessments Plant Uptake Factor Assessment facility - providing our partners with more options
More informationEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY COMMISSION GUIDANCE DOCUMENT 1
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Safety of the Food Chain Pesticides and Biocides COMMISSION GUIDANCE DOCUMENT 1 SANCO/12184/2014 rev. 5.1 14 July 2015 Guidance Document
More informationConsidering Variability in Groundwater Exposure to Pesticides in LCA
Considering Variability in Groundwater Exposure to Pesticides in LCA Georg Geisler, Simon Liechti, Stefanie Hellweg, Konrad Hungerbühler, Swiss Federal Institute of Technology (ETH), Zürich Method of incorporating
More informationInfluence of scenario assumptions on exposure in FOCUS water bodies, as calculated with TOXSWA. Paulien Adriaanse, Alterra, NL
Influence of scenario assumptions on exposure in FOCUS water bodies, as calculated with TOXSWA Paulien Adriaanse, Alterra, NL Overview Water body types in FOCUS sw scenarios TOXSWA 2.0: What is new? Calculation
More informationCanadian Approaches to Soil Risk Assessment
Canadian Approaches to Soil Risk Assessment ECHA/EFSA Topical Scientific Workshop on Soil Risk Assessment Janet Cermak and Mark Bonnell, Environment Canada Lai Gui and Michelle Kivi, Pest Management Regulatory
More informationFinal addendum to the Additional Report - public version -
Final addendum to the Additional Report - public version - Additional risk assessment provided by the rapporteur Member State Greece for the existing active substance TRIFLURALIN according to the Accelerated
More informationRevocation of the 0.1 ppm General Maximum Residue Limit for Food Pesticide Residues [Regulation B (1)]
Discussion Document DIS2003-01 Revocation of the 0.1 ppm General Maximum Residue Limit for Food Pesticide Residues [Regulation B.15.002(1)] (publié aussi en français) January 10, 2003 This document is
More informationProbabilistic risk assessment Modelling exposure and effects
Probabilistic risk assessment Modelling exposure and effects Udo Hommen udo.hommen@ime.fraunhofer.de www.ime.fraunhofer.de Outline Focus on risk assessment for plant protection products Definitions Example
More informationFOCUS Groundwater - Introduction (Part I)
- Introduction (Part I) Scenarios Workgroup (1,2) Recommend appropriate leaching models Define standard scenarios Develop comparable input parameterisation Define a method of processing the model output
More informationBio 430: Chemicals in the environment. Jeffrey Jenkins Department of Environmental and Molecular Toxicology Oregon State University
Bio 430: Chemicals in the environment Jeffrey Jenkins Department of Environmental and Molecular Toxicology Chemical fate: transformation and transport within and between Soil-Air-Water-Biota Source: U.S.
More informationProposed Rule on Conventional Pesticides (40 CFR Part 158) May 3-4, 2005 Holiday Inn Rosslyn 1900 N. Fort Myer Drive Arlington, VA 22209
Proposed Rule on Conventional Pesticides (40 CFR Part 158) May 3-4, 2005 Holiday Inn Rosslyn 1900 N. Fort Myer Drive Arlington, VA 22209 Environmental Fate and Effects Division Environmental Fate Data
More informationExposure assessment for pesticide inputs into surface waters via surface runoff, erosion and drainage in Germany (GERDA)
Exposure assessment for pesticide inputs into surface waters via surface runoff, erosion and drainage in Germany (GERDA) Martin Bach 1, Dietlinde Großmann 2, Djamal Guerniche 3, Udo Hommen 4, Michael Klein
More informationDevelopment of Groundwater Exposure Simulation Tool for Pesticides Used in Rice Paddy in China
Pesticide Behaviour in Soil, Water and Air Development of Groundwater Exposure Simulation Tool for Pesticides Used in Rice Paddy in China Zhou Junying Nanjing Institute of Environmental Sciences, MEP of
More informationAccording to BPR Article 19 and Annex II, information on analytical methods is required
Date of draft: 1 (5) Definition of relevant impurities Introduction ECHA is currently working on a revision of the Guidance on Technical Equivalence a (TE Guidance). Among other things, it is necessary
More informationREPORT OF EFSA. Public consultation on the existing Guidance Document on Persistence in Soil. Prepared by PPR Unit. Issued on 26 Jan 2009
REPORT OF EFSA Public consultation on the existing Guidance Document on Persistence in Soil Prepared by PPR Unit (Question No EFSA-Q-2007-184) Issued on 26 Jan 2009 Contents This compilation contains the
More information7th September Second workshop on pesticide fate in soil and water in the northern zone Challenges for pesticide risk assessment.
Can the Danish regulatory modelling approach assess the leaching risk of pesticides and their metabolites as monitored via the Danish Pesticide Leaching Assessment Programme? 7th September 2016 Second
More informationSite- and use-specific risk assessment for diffuse-source pesticide inputs into German surface waters
4th European Modelling Workshop, 21-22 Nov 2005, Paris Site- and use-specific risk assessment for diffuse-source pesticide inputs into German surface waters as part of the Information System on Integrated
More informationapproach, specific protection goals and linking exposure to effects Info Session on Aquatic Guidance 6/7 November 2013
Introduction ti to terminology, tiered approach, specific protection goals and linking exposure to effects Theo Brock, Alterra, Wageningen UR (PPR Panel Member) Info Session on Aquatic Guidance 6/7 November
More informationDrinking Water Case Studies
Drinking Water Case Studies CLA Regulatory Conference April 6, 2017 Pat Havens, PhD Principal Research Scientist Dow AgroSciences LLC Introduction Registrants have worked for many years to understand potential
More informationRefinement of the FOCUS Stream Scenario
Refinement of the FOCUS Stream Scenario Mark Russell Third European Modelling Workshop Catania, Italy February 17-19, 2004 Sequential steps for FOCUS surface water models Type of Exposure Estimate Step
More informationFramework for the Assessment of Plant Protection Products
Framework for the Assessment of Plant Protection Products Department of Pesticides and Gene Technology Danish Environmental Protection Agency May 2011 Revised February 2013 Revised April 2014 Revised May
More informationCoupling DREAM Suite and PEARL for Parameter Inference in a Bayesian Framework , 5th HYDRUS Conference in Prague Stephan Sittig
Coupling DREAM Suite and PEARL for Parameter Inference in a Bayesian Framework 31.03.2017, 5th HYDRUS Conference in Prague Stephan Sittig 1 Introduction Environmental fate risk assessment for plant protection
More informationA SCENARIO FOR EXPOSURE OF WATER ORGANISMS IN THE NETHERLANDS
A SCENARIO FOR EXPOSURE OF WATER ORGANISMS IN THE NETHERLANDS Aaldrik Tiktak (PBL) Wim Beltman (WUR-Alterra) Jos Boesten (WUR-Alterra) Aleid Dik (Adviesbureau Aleid Dik) Corine van Griethuysen (Ctgb) Mechteld
More informationGUIDANCE OF EFSA. European Food Safety Authority 2,3. European Food Safety Authority (EFSA), Parma, Italy
EFSA Journal 2014;12(5):3662 GUIDANCE OF EFSA EFSA Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and
More informationRisk Assessment Methodologies in Ranking Decontamination Actions on National and Local Level. a Hungarian Experience
Risk Assessment Methodologies in Ranking Decontamination Actions on National and Local Level a Hungarian Experience a workshop on Contaminated Lands in Accession Countries: Benchmarking Historical Heritage
More informationSIMBA (MESOTRIONE 100 SC ) Page 1 of 28. REGISTRATION REPORT Part A. Risk Management
Page 1 of 28 REGISTRATION REPORT Risk Management Product code: MESOTRIONE 100 SC Product name(s): SIMBA Active Substance(s): Mesotrione, 100 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL
More informationHow protective is FOCUS groundwater modelling on sandy soils? A comparison of simulated and measured leachate concentrations
Für Mensch & Umwelt Pesticide Behaviour in Soils, Water and Air, 31 Aug. 2017, York How protective is FOCUS groundwater modelling on sandy soils? A comparison of simulated and measured leachate concentrations
More informationProbabilistic Methods for Assessing Dietary Exposure to Pesticides
Probabilistic Methods for Assessing Dietary Exposure to Pesticides Andy Hart (Fera, UK) Technical Meeting with Stakeholders on Cumulative Risk Assessment EFSA, 11 February 2014 Outline of presentation
More informationGUIDANCE OF EFSA. European Food Safety Authority 2,3. European Food Safety Authority (EFSA), Parma, Italy
EFSA Journal 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 GUIDANCE OF EFSA EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection
More informationHARMONISING ENVIRONMENTAL RISK ASSESSMENTS OF PESTICIDES
HARMONISING ENVIRONMENTAL RISK ASSESSMENTS OF PESTICIDES OECD DEVELOPMENT OF TEST GUIDELINES AND METHODOLOGIES EFSA Scientific Conference on ERA of pesticides Parma, 15-16 November 2016 OECD Secretariat
More informationEFSA Draft Guidance Document on the Risk Assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees) 1
EFSA Journal 20YY;volume(issue):NNNN 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 DRAFT GUIDANCE OF EFSA EFSA Draft Guidance Document on the Risk Assessment of Plant Protection Products on bees (Apis mellifera,
More informationZOL 814 Chemodynamics
ZOL 814 Chemodynamics Generic Expected Environmental Concentration Program (GENEEC) Name: Background: The GENEEC model is used to calculate the Expected Environmental Concentration (EEC) for a generic
More informationBromuconazole 167 g/l + Tebuconazole 107 g/l EC (SOLEIL) Page 1 of 20. REGISTRATION REPORT Part A. Risk Management
Page 1 of 20 REGISTRATION REPORT Part A Risk Management Product code: Bromuconazole 167 g/l + Tebuconazole 107 g/l EC Product name(s): SOLEIL Active Substance(s): Bromuconazole, 167 g/l Tebuconazole, 107
More informationABAMECTINE 1.8% EW (LAOTTA EW) Page 1 of 21. REGISTRATION REPORT Part A. Risk Management
Page 1 of 21 REGISTRATION REPORT Part A Risk Management Product code: ABAMECTIN 1.8% EW Product name(s): LAOTTA EW Active Substance(s): Abamectin, 18 g/l COUNTRY: FRANCE Zonal Rapporteur Member State:
More information2010 Maximum Residue Level (MRL) Workshop Global Regulations Residue Decline Curves Related to MRLs San Francisco, CA June 2-3, 2010
2010 Maximum Residue Level (MRL) Workshop Global Regulations Residue Decline Curves Related to MRLs San Francisco, CA June 2-3, 2010 Phil Brindle, PhD Global MRLs & Import Tolerances BASF Aricultural Solutions,
More informationBUNDESINSTITUT FÜR RISIKOBEWERTUNG
BUNDESINSTITUT FÜR RISIKOBEWERTUNG Mehrfachrückstände von Pflanzenschutzmitteln in Lebensmitteln Teil III Internationale Bewertungskonzepte für Mehrfachrückstände 10.11.2005 Cumulative Risk Assessment:
More informationkeep it short and simple and Refined Risk Assessment placed side by side : PEC Groundwater in France
6 th European Modelling Workshop 10-12 October 2012 Paris keep it short and simple and Refined Risk Assessment placed side by side : PEC Groundwater in France Arnaud CONRAD ANSES Regulated Product Department
More informationCodex Committee on Pesticide Residues 32nd Session
IUPAC Representative Report Codex Committee on Pesticide Residues 32nd Session May 1-8, 2000 The Hague, Netherlands Prepared by Dr. Kenneth D. Racke, Chairman of the IUPAC Commission on Agrochemicals &
More informationDynamic multi-crop model to characterize impacts of pesticides in food. P. Fantke, R. Juraske A. Antón, E. Sevigné, A. Kounina
Dynamic multi-crop model to characterize impacts of pesticides in food P. Fantke, R. Juraske A. Antón, E. Sevigné, A. Kounina Which food crop has highest pesticide load? Goals After the course, all participants
More informationVariations on a Theme, Groundwater Sensitivity
Variations on a Theme, Groundwater Sensitivity Amy Ritter, Waterborne Environmental, Inc. Mark Cheplick, Waterborne Environmental, Inc. Isha Khanijo, Waterborne Environmental, Inc. American Chemical Society,
More informationDutch Registration Procedure for Plant Protection Products and criteria for water organisms Development of guidance in accordance with 91/414 and WFD
Dutch Registration Procedure for Plant Protection Products and criteria for water organisms Development of guidance in accordance with 91/414 and WFD Theo C.M. Brock theo.brock@wur.nl Outline presentation
More informationThe Development of a Chemical Compound. Matthew Veal, PhD Residue Chemistry
The Development of a Chemical Compound Matthew Veal, PhD Residue Chemistry NAICC, January 29, 2015 Disclaimer Forward-Looking Statements This presentation may contain forward-looking statements based on
More informationReview of the Danish risk assessment methodology for pesticides regarding leaching to groundwater
Review of the Danish risk assessment methodology for pesticides regarding leaching to groundwater Ton van der Linden, Colin Brown & Jenny Kreuger Danish Crop Conference - Plantekongres 2016 Herning, Denmark
More informationEuropean Food Safety Authority. European Food Safety Authority (EFSA)
GUIDANCE OF EFSA ADOPTED: 29 August 2017 doi: 10.2903/j.efsa.2017.4982 EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation
More informationEvaluating POPs & PBT as part of the approval
as part of the approval Peter Dohmen, 22 November 2011 Definitions / background Potential consequences Specific considerations: Compartmental approach Use of robust and relevant data Persistence Bioaccumulation
More informationAU.S.Industry Viewpoint on the Design and Use of the Terrestrial Field Dissipation Study
Chapter 1 AU.S.Industry Viewpoint on the Design and Use of the Terrestrial Field Dissipation Study Downloaded via 148.251.232.83 on October 19, 2018 at 16:59:31 (UTC). See https://pubs.acs.org/sharingguidelines
More informationEcotoxicology Studies To Evaluate Adverse Impacts On Non Target Organisms
Ecotoxicology Studies To Evaluate Adverse Impacts On Non Target Organisms Chad Boeckman Research Scientist-Environmental Risk Assessment DuPont Pioneer Joe Huesing, PhD Senior Biotechnology Advisor USAID
More informationMay 15, DELIVERY CONFIRMATION (Co. No. 352) Mr. Tim McPherson DuPont Crop Protection PO Box 30 Newark, DE Dear Mr.
New York State Department of Environmental Conservation Division of Solid and Hazardous Materials Bureau of Pesticides Management Pesticide Product Registration Section 625 Broadway, Albany, New York 12233-7257
More informationQuantifying Runoff Mitigation in STEP 4 Calculations with VFSMOD EU-Scenarios in SWAN 3.0
Quantifying Runoff Mitigation in STEP 4 Calculations with VFSMOD EU-Scenarios in SWAN 3.0 Bjoern Roepke 6 th European Modelling Workshop, Paris 10 th 12 th June 2012 Existing Vegetated Filter Strip (VFS)
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. Safety of the Food chain Chemicals, contaminants, pesticides
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Safety of the Food chain Chemicals, contaminants, pesticides Brussels, 25.09.2012 rev. 3 DG SANCO Working Document on "Evidence Needed to Identify
More informationEnvironmental risk assessment of the pesticide Simplex with the active substances aminopyralid and fluroxypyr
Environmental risk assessment of the pesticide Simplex with the active substances aminopyralid and fluroxypyr Opinion of the Panel on plant protection products Norwegian Scientific Committee for Food Safety
More informationGuidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate E Safety of the food chain Unit E.3 - Chemicals, contaminants, pesticides SANCO/112/2011 rev. 5 1 March 2011 Guidance document
More informationRisk Assessment-- Testing the Probability of Harm
Instructor: Allan Felsot afelsot@tricity.wsu.edu Fall 2005 ES/RP 53 Fundamentals of Environmental Toxicology Lecture 25 Ecological Risk Characterization EPA s Deterministic Methods Eco-Risk A Horse of
More informationSpecial Review of Imazapyr: Proposed Decision for Consultation
Re-evaluation Note REV2014-03 Special Review of Imazapyr: Proposed Decision for Consultation (publié aussi en français) 28 August 2014 This document is published by the Health Canada Pest Management Regulatory
More informationTier-1 and Tier-2A Scenario Parameterisation and Example Calculations 1
EFSA Journal 2012;10(1):2433 SCIENTIFIC REPORT OF EFSA Tier-1 and Tier-2A Scenario Parameterisation and Example Calculations 1 In Support of the Revision of the Guidance Document on Persistence in Soil
More informationCHAPTER # 4. Fate of Pollutants in the Environment
CHAPTER # 4 Fate of Pollutants in the Environment Once a pesticide is introduced into the environment, whether through an application, a disposal or a spill, it is influenced by many processes. These processes
More informationGF-1076 OD (BOA) Page 1 of 30. REGISTRATION REPORT Part A. Risk Management
Page 1 of 30 REGISTRATION REPORT Part A Risk Management Product code: GF-1076 OD Product name(s): BOA Active Substance(s): penoxsulam, 20 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL
More informationFOOTPRINT. Mitigation strategies to reduce pesticide inputs into groundand surface water and their effectiveness a state-of-the-art review
FOOTPRINT Mitigation strategies to reduce pesticide inputs into groundand surface water and their effectiveness a state-of-the-art review S. Reichenberger, M. Bach, A. Skitschak, H.-G. Frede Institute
More informationMitigation of runoff in the FOCUS Surface Water Scenarios
Mitigation of runoff in the FOCUS Surface Water Scenarios Note of the fate group of the Environmental Risk Assessment team of Alterra on the interpretation of the mitigation of runoff in the FOCUS Landscape
More informationQuestions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use'
1 2 3 24 June 2010 EMA/CHMP/SWP/44609/2010 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for
More informationSETAC Europe 23rd Annual Meeting. selected for monitoring can be placed in context of vulnerability for the EU.
105 The first steps towards simplifying the Northern Zone groundwater requirements A. Gimsing, The Danish Environmental Protection Agency; F. Stenemo, Geosigma AB; J. Asp, G. Czub, J. Ostgren, Swedish
More informationEvaluation Manual for the Authorisation of Plant protection products and Biocides according to Regulation (EC) No 1107/2009
Evaluation Manual for the Authorisation of Plant protection products and Biocides according to Regulation (EC) No 1107/2009 NL part Plant protection products Chapter 6 Fate and behaviour in the environment:
More informationFramework for the Assessment of Plant Protection Products
Framework for the Assessment of Plant Protection Products Department of Pesticides and Biocides Danish Environmental Protection Agency May 2011 Revised February 2013 Revised April 2014 Revised May 2016
More informationChris Lythgo Environment Branch (Fate and Behaviour)
Assessments of Leaching to Groundwater in the UK Chris Lythgo Environment Branch (Fate and Behaviour) Overview UK groundwater scenarios How were scenarios selected? When Is Macropore flow modelling required?
More informationEnvironmental toxicology: a tool for risk management
Environmental toxicology: a tool for risk management III. Katalin Gruiz Multispecies toxicity tests Aquatic microcosms Benthic-pelagic microcosms Compartmentalised lake Mixed flask culture mesocosm Pond
More informationDraft agreed by Environmental Risk Assessment Working Party (ERAWP) 31 May Adopted by CVMP for release for consultation 12 July 2012
10 September 2015 EMA/CVMP/ERA/52740/2012 Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very
More informationJoint safety evaluation of substances in printing inks by Germany (BfR) and Switzerland (FSVO)
Federal Department of Home Affairs FDHA Federal Food Safety and Veterinary Office FSVO Risk Assessment Division Joint safety evaluation of substances in printing inks by Germany (BfR) and Switzerland (FSVO)
More informationRisk assessment for mixtures of agricultural chemicals in surface water; a SETAC Pellston workshop update
Risk assessment for mixtures of agricultural chemicals in surface water; a SETAC Pellston workshop update Christopher Holmes, Waterborne Environmental, Inc., VA, USA Mick Hamer, Syngenta, Bracknell, UK
More informationGuidance for the derivation of environmental risk limits Part 11. Variables and default values used in the ERL guidance documents. version 1.
Guidance for the derivation of environmental risk limits Part 11. Variables and default values used in the ERL guidance documents version 1.0 Colophon RIVM 2015 Parts of this publication may be reproduced,
More informationEnvironmental modelling and validation
Environmental modelling and validation Colin Brown University of York, UK 2 nd SETAC Europe Special Science Symposium Overview Predicted environmental concentrations Models, validation and goodness-of-fit
More informationMonsanto s Field Trials for Assessing Dicamba Off-Target Movement Due to Volatility.
Monsanto s Field Trials for Assessing Dicamba Off-Target Movement Due to Volatility. Evaluating Volatility is a Three Step Process. WE NEED TO EXAMINE EACH STEP FOR ITS POSSIBLE CONTRIBUTION TO OFF-TARGET
More informationRefined exposure estimation to support an Environmental Assessment for a veterinary medicine
May 25, 2016 Refined exposure estimation to support an Environmental Assessment for a veterinary medicine Christopher Holmes, Isha Khanijo, Joshua Amos and Amy Ritter Waterborne Environmental, Inc. Holly
More informationTowards a better understanding of the behaviour of pesticides in the environment: where did Allan Walker lead us and where now?
Towards a better understanding of the behaviour of pesticides in the environment: where did Allan Walker lead us and where now? Richard Allen Slide 1 Topics Bioavailability of Residues in Soil Microbiological
More informationProperties of Matter. Chemical Properties and Effects on Pollutant Fate. Characteristics of Chemical Changes. Physical Characteristics
Properties of Matter Chemical Properties and Effects on Pollutant Fate Physical Characteristics Characteristics of Chemical Changes Melting point Boiling point Vapor pressure Color State (solid, liquid,
More informationInnovative tools for pesticide risk management
Innovative tools for pesticide risk management 10, avenue Buffon Adresse 45 071 Orléans Cedex 2 France Adresse +33 238 63 64 65 adresse Igor DUBUS (i.dubus@footways.eu) & Stefan REICHENBERGER Footways
More informationResidues on food items for birds and mammal. Robert Luttik, National Institute for Public Health and the Environment, NL
Residues on food items for birds and mammal Robert Luttik, National Institute for Public Health and the Environment, NL Valencia workshop 2007 1 History: Nomograms of Kenaga The EPA food-chain (Kenaga)
More informationCase Study: USEPA Benthic Invertebrate Risk Assessment for Endosulfan
U.S. Environmental Protection Agency 1 Case Study: USEPA Benthic Invertebrate Risk Assessment for Endosulfan Presentation to: European Chemicals Agency Topical Scientific Workshop: Risk Assessment for
More informationCumulative assessment groups, their implementation in the nondietary risk assessment and their timelines
Cumulative assessment groups, their implementation in the nondietary risk assessment and their timelines Manuela Tiramani Interzonal workshop Harmonisation of risk assessment in section toxicology AGES
More informationCA2744 (ALLUM MZ) Page 1 of 26. REGISTRATION REPORT Part A. Risk Management
Page 1 of 26 REGISTRATION REPORT Part A Risk Management Product code: CA2744 Product name: ALLUM MZ Active substances: fosetyl-aluminium, 444 g/kg, 311 g/kg COUNTRY: FRANCE Zonal Rapporteur Member State:
More informationGetIPM.com Children fall ill after pesticides sprayed -- 2,4-D applied to lawns near family's home Over-the-Counter Herbicides Pose a Significant Thre
Environmental Fate of Herbicides: The Disappearing Act Adam Hixson BASF, The Chemical Company GetIPM.com Children fall ill after pesticides sprayed -- 2,4-D applied to lawns near family's home Over-the-Counter
More informationDISCOVER OUR SEGMENT REGULATORY SCIENCE
DISCOVER OUR SEGMENT REGULATORY SCIENCE Our focus In the demanding regulatory environment of the EU, expert knowledge is essential to gaining approval for substances and products. That is why the scientific
More informationEXPOSURE TO GLYPHOSATE: SHOULD WE WORRY? Sílvia Lacorte Department of Environmental Chemistry, IDAEA-CSIC, Barcelona
EXPOSURE TO GLYPHOSATE: SHOULD WE WORRY? Sílvia Lacorte Department of Environmental Chemistry, IDAEA-CSIC, Barcelona Top 10 pesticides by usage in Spain (out of 350) Glyphosate Metam sodium Mancozeb Chlorpyriphos
More informationREGISTRATION REPORT Part A Risk Management. Product code: ALB 019 Product name(s): FLAME. Southern Zone Zonal Rapporteur Member State: France
REGISTRATION REPORT Part A Risk Management Product code: ALB 019 Product name(s): FLAME Chemical active substance(s): Tribenuron-methyl, 500 g/kg Southern Zone Zonal Rapporteur Member State: France NATIONAL
More informationTBZ WG Page 1 of 26. REGISTRATION REPORT Part A. Risk Management
Page 1 of 26 REGISTRATION REPORT Part A Risk Management Product code: Product name(s): HORIZON ARBO - Active Substance(s): Tebuconazole WG 25 (250 g/kg) COUNTRY: FRANCE NATIONAL ASSESSMENT Application
More informationRegion 6 Risk Management Addendum - Draft Human Health Risk Assessment Protocol for Hazardous Waste Combustion Facilities
United States Region 6 Multimedia EPA-R6-98-002 Environmental Protection Planning and Permitting July 1998 Agency Division www.epa.gov/region06 Region 6 Risk Management Addendum - Draft Human Health Risk
More informationEthephon SL 120 G [ ] (PRM 12 RP) Page 1 of 56. REGISTRATION REPORT Part A. Risk Management
Page 1 of 56 REGISTRATION REPORT Risk Management Product code: Product name: PRM 12 RP Active Substance: ethephon, 120 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE
More informationKey Environmental and Physicochemical Parameters Influencing PRZM-GW Predicted Groundwater Residues
Key Environmental and Physicochemical Parameters Influencing PRZM-GW Predicted Groundwater Residues Timothy Negley & Andrew Newcombe (ARCADIS U.S., Inc.) Dirk Young (USEPA, EFED) American Chemical Society,
More informationFrance s proposal for Guidelines about setting Maximum Residue Limits in honey
France s proposal f Guidelines about setting Maximum Residue Limits in honey Patrice Carpentier*, Anne Marie Chapel*, MariePierre Chauzat*, Bernard Declercq, Robert Delme, Axel Decourtye, Alexia Faure*,
More informationIsacco Luca 1, Ferrari Federico 2, Merli Annalisa 3, Capri Ettore 1, Suciu Nicoleta 1. DiSTAS, Università Cattolica del Sacro Cuore, Piacenza, Italy 2
Higher tier approaches for linking environmental exposure to bioaccumulation in regulatory context: MERLIN-Expo Tool estimations versus Monitoring data Isacco Luca 1, Ferrari Federico 2, Merli Annalisa
More informationPesticide risk maps for targeting advice activity in Wensum catchment. March developed by:
Pesticide risk maps for targeting advice activity in Wensum catchment March 2007 developed by: using technology Executive summary Areas with high vulnerability of IPU entering streams during peak drainflow
More informationEnvironmental risk assessment. Dr Stuart Dobson Centre for Ecology & Hydrology, United Kingdom
Environmental risk assessment Dr Stuart Dobson Centre for Ecology & Hydrology, United Kingdom Reasons for doing international environmental risk assessment: high exposure or tonnage production regional
More informationOECD GUIDELINES FOR THE TESTING OF CHEMICALS
Adopted: 8 January 2007 OECD GUIDELINES FOR THE TESTING OF CHEMICALS Residues in Rotational Crops (Limited Field Studies) INTRODUCTION 1. Rotational crops are any field or aquatic crops, which may be produced
More informationHigher-dimensional environmental modelling in soil Tom Schröder BASF SE
Higher-dimensional environmental modelling in soil Tom Schröder BASF SE 15/10/2010 1 Processes in soil rainfall evaporation Soil surface runoff Vadose zone Flow of water (gravity dominating) Transport
More informationEnvironmental Safety Assessment of New Animal Drugs
Environmental Safety Assessment of New Animal Drugs Wesley Hunter, Ph.D. U.S. Food and Drug Administration Center for Veterinary Medicine Environmental Safety Team Outline Legal mandates and implementation
More informationThe Development and Status of the FOCUS Surface Water Scenarios. FOCUS Surface Water Scenarios within Directive 91/414/EEC
The Development and Status of the within Directive 91/414/EEC Jan Linders on behalf of the FOCUS working group on Surface Water Scenarios, RIVM-CSR, Bilthoven, NL, presented at SETAC2001, Madrid 23-4-01
More information33. Fate of pesticides in soil and plant.
33. Fate of pesticides in soil and plant. What Happens to Pesticides When a pesticide is released into the environment many things happen to it. Sometimes what happens is beneficial. For example, the leaching
More information