Phase II in the European Union Neil Mackay, Dave Arnold PEC Excreta - PDF document

Development of Exposure Modelling Approaches for Veterinary Medicines Phase II in the European Union Neil Mackay, Dave Arnold PEC Excreta PEC Soil Fate and behaviour in soil: Cambridge Environmental Assessments Boxworth, UK • Degradation Antonio DiGuardo • Leaching to groundwater Research Project Department of Structural and Functional Biology University of Insubria • Run-off and drainage to surface VM02133 Varese, Italy waters Alex Tait Veterinary Medicines Directorate Addlestone, UK Effects on non-target organisms: • Plants • Earthworms • Soil micro-organisms • Dung fauna/Grassland invertebrates (Insecticidal activity) PEC GW Phase II Project Aims Fate and behaviour in Effects on non-target • To provide a user-friendly tool to facilitate water and sediment: organisms: regulatory exposure assessment for soils, • Degradation • Fish surface waters and groundwaters that takes • Partitioning to sediment • Aquatic Invertebrates into account…. • Algae – Animal characteristics – Associated manure characteristics – Local agricultural practices – Characteristics of a wide range of European PEC SW destination environments – Fate and behaviour PEC Sediment

Conceptual Framework Conceptual Framework Dose Dose • Admin. Rate • Frequency • Adsorption Standard • Metabolism PEC Excreta • Storage time Calculations • Degradation in storage • Manure characteristics • Loading rate restrictions Modified Fugacity PEC Soil PEC SW LEACHP Model • Flow rate • Soil texture • Depth • Hydrology • Organic carbon • Vegetation content (sediment • Topography & suspended Modified sediment). Fugacity PEC GW PEC Sediment LEACHP Model Conceptual Framework Conceptual Framework • Dosage (mg/kg) for each relevant livestock • Physical Chemistry Definition of Definition of category: substance substance – Vapour pressure • Group 1: Bovine (Calves, dairy, beef) – Solubility Definition of Definition of • Group 2: Swine (Piglets & adults) – Hydrolysis target target – Octanol-water partition coefficient (P ow ) • Group 3: Ovine (Sheep) – Dissociation constant (pKa) • Group 4: Poultry (Broiler chicken, laying hen) Identification of most Identification of most • Maximum number of applications relevant scenarios relevant scenarios • Basic Environmental Fate • Illustrative timings for certain treatments – Degradation in soil • Data used to carry out Phase 1 PEC values Agricultural practices and – Adsorption/desorption Agricultural practices and for soil based on approach described by relevant routes of entry relevant routes of entry • Advanced Environmental Fate Spaepen et al . and Montforts et al . – Water-sediment study data – Degradation rate in manure and/or slurry Relevant time Relevant time window window

Conceptual Framework Conceptual Framework • Should address a wide range of potential Definition of Cool/continental EU exposure situations that could be substance Brandenburg (D) encountered: (Central & Eastern Germany) Definition of • Treatment regimes target • Degradation potential • Characteristics of animals treated Identification of most • Agricultural practices relevant scenarios • Environmental characteristics • 12 scenarios in total: Agricultural practices and • 1 scenario in cool/continental EU relevant routes of entry • 9 scenarios in moderate/temperate EU • 2 scenarios in warm/semi-arid EU Relevant time • Scenarios should be prominent sites of window diverse livestock production (Eurostat) Conceptual Framework Conceptual Framework Moderate/temperate EU Moderate/temperate EU Denmark Borders, Central, Fife, Lothian & Tay (UK) (+Southern Sweden & Northern Germany) (Scotland) Ireland North Yorkshire (UK) (+Northern Ireland) (Northern England) Noord Brabant (NL) Clwyd, Dyfed, Gwynedd & (+ Belgium & Nordrhein Westfalia) Powys (UK) (Wales & the Midlands) Bretagne (F) (Northwest France) Cornwall & Devon (UK) (Southern England) Midi-Pyrenees (F) (Pyrenees: South Central France and Northeast Spain)

Conceptual Framework Conceptual Framework Warm/semi-arid EU • Drainage Scenarios: • Run-Off Scenarios: Andalucia (E) Noord Brabant Clwyd, Dyfed, Gwynedd Worst Case (Southern Spain & Portugal) and Powys Denmark North Yorkshire Cornwall & Devon Emilia-Romagna (I) Bretagne Midi-Pyrenees (Northern Italy, Mediterranean & Best Case Adriatic Coast) Emilia Romagna Andalucia • Currently unallocated (pending data): • Ireland • Brandenburg • Border, Central, Fife, Lothian & Tay Conceptual Framework Conceptual Framework • Representative livestock demographics: • Associated restrictions on application Definition of Definition of timings for manure and slurry based upon • Allows a degree of mitigation (where relevant) substance substance NVZ status in each relevant Member State: where only a subset of the population is treated – Example of closed spreading periods in Definition of Definition of • Typical manure/slurry management the UK: target target strategies: • Sandy or shallow soils in arable production, and no autumn sown crop • Storage: Allows a degree of mitigation Identification of most Identification of most associated where degradation data are – Do not spread slurry, poultry relevant scenarios relevant scenarios available manures or liquid digested sludge in August, September or October • Typical manure/slurry application rates in each relevant Member State Agricultural practices and Agricultural practices and • Rate restrictions: Nitrate Vulnerable Zones relevant routes of entry relevant routes of entry • Proportions of solid manure and slurry applied to arable land and grassland for each ‘farm scenario’ Relevant time Relevant time window window

Database Application • Database allows simulation of both ‘worst-case’ and typical application regimes • Database allows adaptation of ‘farm scenarios’ to consider impact of practices for regionally related Member States • Database allows assessment of practicality of various Environmental Characteristics risk management proposals • Provision of data allowing multiple combinations of critical drivers allows for possibility of conducting limited probabilistic risk assessment: –Timings of application – Livestock demographics –Application rates – Body weights –Proportions applied to arable – Storage times and grassland Status • Currently developing scenarios and establishing three software components: – Graphic User Interface + Databases – Groundwater & Soil Model Manure Practices – Surface Water & Sediment Model • Project completion date scheduled for Nov 2004

For further information… • Please contact: – Neil Mackay (CEA): neil.mackay@cea-res.co.uk – Alex Tait (VMD): a.tait@vmd.defra.gsi.gov.uk Development of Exposure Modelling Thank You! Approaches for Veterinary Medicines Stakeholders’ Workshop Cambridge November 2004