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VM Table of Contents Chapter 1: Introduction (9 p) Mark Crane, Katie Barrett, and Alistair Boxall Chapter 2: Use of Veterinary Medicines in the Environment (25 p) Alistair Boxall, Mark Crane, Christian Corsing, Chuck Eirkson, and Alex Tait 2.1 Introduction 2.2 Veterinary medicine use 2.2.1 Parasiticides 2.2.2 Antibacterials 2.2.3 Coccidiostats and antiprotozoals 2.2.4 Antifungals 2.2.5 Aquaculture medicines 2.2.6 Hormones 2.3 Pathways to the environment 2.3.1 Emissions during manufacturing and formulation 2.3.2 Aquaculture 2.3.3 Agriculture (livestock production) 2.3.4 Companion/domestic animals 2.3.5 Disposal of unwanted drugs 2. 4 Summary 2.5 References Chapter 3: Environmental Risk Assessment and Management of Veterinary Medicines (71 p) Joop de Knecht, Tatiana Boucard, Bryan Brooks, Mark Crane, Sarah Gerould, Jan Koschorreck, Gregor Scheef, Keith Solomon, and Zhixing Yan 3.1. Introduction 3.2 Veterinary medicines in regulatory perspective 3.2.1 Legislation, scope and past guidelines for Environmental Risk Assessment (ERA) of veterinary medicines 22.214.171.124 United States 126.96.36.199 European Union 188.8.131.52 Japan 184.108.40.206 Australia 220.127.116.11 Canada 3.2.2 Current guidelines: VICH and VICH-EU-TGD 3.3 Refinement of VMP Risk Assessments 3.3.1 Metabolism and Degradation 3.3.2 Combination products 3.3.3 Refinement of environmental exposure predictions 3.3.4 Probabilistic Risk Assessment of Veterinary medicines 18.104.22.168 Case study of a probabilistic risk assessment for dung fauna 3.4. Risk Management 3.4.1 Risk mitigation measures within product authorization/ approval 3.4.2 Risk assessment and management beyond authorization/approval 22.214.171.124 The communication challenge 126.96.36.199 Incidence reporting and pharmacovigilance 188.8.131.52.1 Reporting of an adverse event 184.108.40.206.2 Validity of an adverse event 220.127.116.11.3 Identifying environmental problems 18.104.22.168.4 Incidence calculation 3.4.3 Retrospective risk assessment 3.4.4 Postmarket monitoring and remediation 22.214.171.124 Monitoring endpoints Chapter 4: Exposure Assessment of Veterinary Medicines in Aquatic Systems (72 p) Chris Metcalfe, Alistair Boxall, Kathrin Fenner, Dana Kolpin, Mark Servos, Eric Silberhorn, and Jane Staveley 4.1. Introduction 4.2. Sources of veterinary medicines in the aquatic environment 4.2.1. Treatments used in agriculture 4.2.2 Treatments used in aquaculture 4.3. Experimental studies into the entry, fate and transport of veterinary medicines in aquatic systems 4.3.1 Aquatic exposure to veterinary medicines used to treat livestock 126.96.36.199 Leaching to groundwater 188.8.131.52 Movement to surface water 184.108.40.206 Receiving waters 220.127.116.11 Predicting exposure 18.104.22.168 Comparison of modelled concentrations with measured concentrations 4.3.2 Aquaculture treatments 22.214.171.124 Inputs and fate of marine aquaculture treatments 126.96.36.199 Freshwater Aquaculture 188.8.131.52 Modelling exposure from aquaculture treatments 4.4 Conclusions Chapter 5: Assessing the Aquatic Hazards of Veterinary Medicines (67 p) Bryan W. Brooks, Gerald T. Ankley, James F. Hobson, James M. Lazorchak, Roger D. Meyerhoff, Keith R. Solomon 5.1 Introduction 5.2 Protection goals 5.3 Approaches to assess effects of veterinary medicines 5.3.1 Current methods of assessing aquatic effects for risk assessment 184.108.40.206 Lower tier approaches 220.127.116.11 Higher tier testing 18.104.22.168 Limitations to current approaches 5.3.2 Novel approaches to aquatic effects assessment 22.214.171.124 Use of chemical characteristics, target organism efficacy data, toxicokinetic data and mammalian toxicology data 126.96.36.199.1 Effects assessment 188.8.131.52.2 Use of chemical characteristics and ADME data in assessment of bioaccumulation potential 184.108.40.206 Use of ecotoxicogenomics in ecological effects assessment 5.4 Application Factors and Species Sensitivities 5.5 Effects of veterinary medicines in the natural environment 5.5.1 Episodic Exposures 5.5.2 Matrix effects 5.5.3 Metabolites and degradates 5.5.4 Mixtures 5.5.5 Enantiomer specific hazard 5.5.6 Sorption to sediment 5.5.7 Assessing effects on communities 5.6 Conclusions 5.7 References Chapter 6: Exposure Assessment of Veterinary Medicines in Terrestrial Systems (51 p) Louise Pope, Alistair Boxall, Christian Corsing, Bent Halling-Sørensen, Alex Tait, and Edward Topp 6.1 Introduction 6.2 Absorption and excretion by animals 6.3 Fate during manure storage 6.4 Releases to the environment 6.5 Factors affecting dissipation in the farm environment 6.5.1 Dissipation and transport in dung systems 6.5.2 Dissipation and transport in soil systems 220.127.116.11 Biotic degradation processes 18.104.22.168 Abiotic degradation processes 22.214.171.124 Sorption to soil 6.5.3 Bound residues 6.6 Uptake by plants 6.7 Models for estimating the concentration of veterinary medicine in soil 6.7.1 Intensively reared animals 6.7.2 Pasture animals 6.7.3 PEC refinement 6.8 Research needs 6.9 References Chapter 7: Assessing the Effects of Veterinary Medicines on the Terrestrial Environment (45 p) Katie Barrett, Kevin Floate, John Jensen, Joe Robinson, Neil Tolson 7.1 Introduction 7.2 Considerations unique to veterinary medicines 7.2.1 Routes of entry 7.2.2 Additional safety data available in the dossier 7.2.3 Residue data and detoxification by the target animal species 7.3 Protection Goals 7.4 Tiered Testing Strategy 7.5 Justification for existing testing methods 7.6 Use of indicator species 7.7 Short term/sub-lethal effects tests 7.8 Tier A testing 7.8.1 Physicochemical properties 7.8.2 Fate 7.8.3 Microorganisms 7.8.4 Plants 7.8.5 Earthworms 7.8.6 Collembolans 7.8.7 Dung fauna 7.9 Tier B testing 7.10 Tier C testing 7.10.1 Mesocosm and field testing 7.10.2 Testing of Additional Species 7.10.3 Monitoring Studies 7.11 Calculation of PNEC Concentrations and use of assessment factors 7.12 Metabolite Testing in Tier A and B 7.13 Secondary poisoning 7.14 Bound residues 7.15 Alternative endpoints 7.16 Modeling population and ecosystem effects, e.g., bio-indicator approaches 7.17 Research needs 7.18 References Chapter 8: Workshop Conclusions and Recommendations (11 p) Mark Crane, Katie Barrett, and Alistair Boxall 8.1 Workshop Conclusions 8.2 Workshop Recommendations
Library of Congress Subject Headings for this publication:
Veterinary drugs -- Environmental aspects.