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

Development of Exposure Modelling Approaches for Veterinary Medicines in the European Union

Neil Mackay, Dave Arnold

Cambridge Environmental Assessments Boxworth, UK

Alex Tait

Veterinary Medicines Directorate Addlestone, UK

Antonio DiGuardo

Department of Structural and Functional Biology University of Insubria Varese, Italy

Research Project VM02133

Phase II

Fate and behaviour in soil:

• Degradation
• Leaching to groundwater
• Run-off and drainage to surface

waters

Effects on non-target

• rganisms:
• Plants
• Earthworms
• Soil micro-organisms
• Dung fauna/Grassland

invertebrates (Insecticidal activity)

PECSoil PECGW PECExcreta

Phase II

Fate and behaviour in water and sediment:

• Degradation
• Partitioning to sediment

Effects on non-target

• rganisms:
• Fish
• Aquatic Invertebrates
• Algae

PECSW PECSediment

Project Aims

• To provide a user-friendly tool to facilitate

regulatory exposure assessment for soils, surface waters and groundwaters that takes into account….

– Animal characteristics – Associated manure characteristics – Local agricultural practices – Characteristics of a wide range of European destination environments – Fate and behaviour

Conceptual Framework

Dose

• Admin. Rate
• Frequency
• Adsorption
• Metabolism
• Storage time
• Degradation in storage
• Manure characteristics
• Loading rate restrictions
• Soil texture
• Hydrology
• Vegetation
• Topography

PECSoil PECExcreta PECGW PECSW PECSediment

• Flow rate
• Depth
• Organic carbon

content (sediment & suspended sediment).

Conceptual Framework

Dose Modified LEACHP Standard Calculations Modified LEACHP Fugacity Model Fugacity Model

Conceptual Framework

Definition of substance Definition of target Identification of most relevant scenarios Agricultural practices and relevant routes of entry Relevant time window

• Physical Chemistry

–Vapour pressure –Solubility –Hydrolysis –Octanol-water partition coefficient (Pow) –Dissociation constant (pKa)

• Basic Environmental Fate

–Degradation in soil –Adsorption/desorption

• Advanced Environmental Fate

–Water-sediment study data –Degradation rate in manure and/or slurry

Conceptual Framework

Definition of substance Definition of target Identification of most relevant scenarios Agricultural practices and relevant routes of entry Relevant time window

• Dosage (mg/kg) for each relevant livestock

category:

• Group 1: Bovine (Calves, dairy, beef)
• Group 2: Swine (Piglets & adults)
• Group 3: Ovine (Sheep)
• Group 4: Poultry (Broiler chicken, laying hen)
• Maximum number of applications
• Illustrative timings for certain treatments
• Data used to carry out Phase 1 PEC values

for soil based on approach described by Spaepen et al. and Montforts et al.

Conceptual Framework

Definition of substance Definition of target Identification of most relevant scenarios Agricultural practices and relevant routes of entry Relevant time window

• Should address a wide range of potential

exposure situations that could be encountered:

• Treatment regimes
• Degradation potential
• Characteristics of animals treated
• Agricultural practices
• Environmental characteristics
• 12 scenarios in total:
• 1 scenario in cool/continental EU
• 9 scenarios in moderate/temperate EU
• 2 scenarios in warm/semi-arid EU
• Scenarios should be prominent sites of

diverse livestock production (Eurostat)

Conceptual Framework

Cool/continental EU

Brandenburg (D)

(Central & Eastern Germany)

Conceptual Framework

Moderate/temperate EU

Borders, Central, Fife, Lothian & Tay (UK)

(Scotland)

North Yorkshire (UK)

(Northern England)

Clwyd, Dyfed, Gwynedd & Powys (UK)

(Wales & the Midlands)

Cornwall & Devon (UK)

(Southern England)

Conceptual Framework

Moderate/temperate EU

Denmark

(+Southern Sweden & Northern Germany)

Ireland

(+Northern Ireland)

Noord Brabant (NL)

(+ Belgium & Nordrhein Westfalia)

Bretagne (F)

(Northwest France)

Midi-Pyrenees (F)

(Pyrenees: South Central France and Northeast Spain)

Conceptual Framework

Warm/semi-arid EU

Andalucia (E)

(Southern Spain & Portugal)

Emilia-Romagna (I)

(Northern Italy, Mediterranean & Adriatic Coast)

Conceptual Framework

• Drainage Scenarios:

Noord Brabant Denmark Cornwall & Devon Midi-Pyrenees

• Run-Off Scenarios:

Clwyd, Dyfed, Gwynedd and Powys North Yorkshire Bretagne Emilia Romagna Andalucia

• Currently unallocated (pending data):
• Ireland
• Brandenburg
• Border, Central, Fife, Lothian & Tay

Worst Case Best Case

Conceptual Framework

Definition of substance Definition of target Identification of most relevant scenarios Agricultural practices and relevant routes of entry Relevant time window

• Representative livestock demographics:
• Allows a degree of mitigation (where relevant)

where only a subset of the population is treated

• Typical manure/slurry management

strategies:

• Storage: Allows a degree of mitigation

associated where degradation data are available

• Typical manure/slurry application rates in

each relevant Member State

• Rate restrictions: Nitrate Vulnerable Zones
• Proportions of solid manure and slurry

applied to arable land and grassland for each ‘farm scenario’

Conceptual Framework

Definition of substance Definition of target Identification of most relevant scenarios Agricultural practices and relevant routes of entry Relevant time window

• Associated restrictions on application

timings for manure and slurry based upon NVZ status in each relevant Member State:

–Example of closed spreading periods in the UK:

• Sandy or shallow soils in arable

production, and no autumn sown crop –Do not spread slurry, poultry manures or liquid digested sludge in August, September or October

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

risk management proposals

• Provision of data allowing multiple combinations of

critical drivers allows for possibility of conducting limited probabilistic risk assessment:

– Livestock demographics – Body weights – Storage times –Timings of application –Application rates –Proportions applied to arable and grassland

Environmental Characteristics Manure Practices

Status

• Currently developing scenarios and

establishing three software components:

– Graphic User Interface + Databases – Groundwater & Soil Model – Surface Water & Sediment Model

• Project completion date scheduled for

Nov 2004

Development of Exposure Modelling Approaches for Veterinary Medicines

Stakeholders’ Workshop Cambridge November 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 Thank You!