Veterinary Medicines in the Environment

Surface water sampling programs across the globe have shown the presence of many different classes of medicines. The potential risks associated with the release of these medicines into the environment have become an increasingly important issue for environmental regulators. Effects of Veterinary Medicines in the Environmentexamines the current state of the science in evaluating the potential risks of veterinary medicines to aquatic and terrestrial ecosystems.International Panel Provides GuidanceThe book brings together more than 30 experts, from eight countries, with expertise in risk assessment, environmental toxicology and chemistry, and environmental policy and regulation. These experts provide guidance, based on standard risk assessment approaches, on how to assess the environmental effects of veterinary medicines. The text discusses pathways to the environment, exposure and effects assessment, and risk assessment and management in terrestrial and aquatic environments. Itreviews classes of veterinary medicines and current regulations, identifies the environmental fate of the medicines, and assesses the use of read-across, QSAR, and other modeling approaches.Detailed Coverage of Technical ApproachesAn examination of the current state of the science, the book provides integrated content in a single source. It includes detailed coverage of technical approaches that help practitioners better understand the environmental risks of veterinary medicines.

List of Figures	p. xiii
List of Tables	p. xv
About the Editors	p. xvii
Workshop Participants	p. xix
Foreword	p. xxi
Acknowledgments	p. xxv
Introduction	p. 1
References	p. 3
Uses and Inputs of Veterinary Medicines in the Environment	p. 7
Introduction	p. 7
Veterinary Medicine Use	p. 7
Parasiticides	p. 8
Antibacterials	p. 8
Coccidiostats and Antiprotozoals	p. 10
Antifungals	p. 10
Aquaculture Medicines	p. 10
Hormones	p. 10
Growth Promoters	p. 10
Other Medicinal Classes	p. 11
Pathways to the Environment	p. 11
Emissions during Manufacturing and Formulation	p. 11
Aquaculture	p. 12
Agriculture (Livestock Production)	p. 13
Companion and Domestic Animals	p. 14
Disposal of Unwanted Drugs	p. 15
Summary	p. 16
References	p. 17
Environmental Risk Assessment and Management of Veterinary Medicines	p. 21
Introduction	p. 21
Veterinary Medicines in Regulatory Perspective	p. 23
Legislation, Scope, and Past Guidelines for Environmental Risk Assessment (ERA) of Veterinary Medicines	p. 23
United States	p. 24
European Union	p. 25
Japan	p. 26
Australia	p. 26
Canada	p. 26
Current Guidelines: VICH and the VICH-EU Technical Guidance Document (VICH-EU-TGD)	p. 27
Refinement of Veterinary Medicinal Product (VMP) Risk Assessments	p. 33
Metabolism and Degradation	p. 33
Combination Products	p. 35
Refinement of Environmental Exposure Predictions	p. 36
Probabilistic Risk Assessment of Veterinary Medicines	p. 36
Case Study of a Probabilistic Risk Assessment for Dung Fauna	p. 37
Risk Management	p. 41
Risk Mitigation Measures within Product Authorization or Approval	p. 42
Risk Assessment and Management beyond Authorization or Approval	p. 44
Communication Challenge	p. 44
Incidence Reporting and Pharmacovigilance	p. 47
Retrospective Risk Assessment	p. 49
Postmarket Monitoring and Remediation	p. 51
Monitoring Endpoints	p. 51
References	p. 52
Exposure Assessment of Veterinary Medicines in Aquatic Systems	p. 57
Introduction	p. 57
Sources of Veterinary Medicines in the Aquatic Environment	p. 58
Treatments Used in Agriculture	p. 58
Treatments Used in Aquaculture	p. 61
Experimental Studies into the Entry, Fate, and Transport of Veterinary Medicines in Aquatic Systems	p. 62
Aquatic Exposure to Veterinary Medicines Used to Treat Livestock	p. 62
Leaching to Groundwater	p. 63
Movement to Surface Water	p. 63
Predicting Exposure	p. 65
Comparison of Modeled Concentrations with Measured Concentrations	p. 66
Aquaculture Treatments	p. 73
Inputs and Fate of Marine Aquaculture Treatments	p. 75
Freshwater Aquaculture	p. 76
Modeling Exposure from Aquaculture Treatments	p. 77
Conclusions	p. 89
References	p. 91
Assessing the Aquatic Hazards of Veterinary Medicines	p. 97
Introduction	p. 97
Protection Goals	p. 98
Approaches to Assess Effects of Veterinary Medicines	p. 98
Current Methods of Assessing Aquatic Effects for Risk Assessment	p. 98
Lower Tier Approaches	p. 99
Higher Tier Testing	p. 99
Limitations to Current Approaches	p. 101
Novel Approaches to Aquatic Effects Assessment	p. 102
Use of Chemical Characteristics, Target Organism Efficacy Data, Toxicokinetic Data, and Mammalian Toxicology Data	p. 102
Use of Ecotoxicogenomics in Ecological Effects Assessment	p. 108
Application Factors and Species Sensitivities	p. 110
Effects of Veterinary Medicines in the Natural Environment	p. 113
Episodic Exposures	p. 114
Matrix Effects	p. 114
Metabolites and Degradates	p. 115
Mixtures	p. 116
Enantiomer-Specific Hazard	p. 117
Sorption to Sediment	p. 118
Assessing Effects on Communities	p. 119
Conclusions	p. 121
References	p. 122
Exposure Assessment of Veterinary Medicines in Terrestrial Systems	p. 129
Introduction	p. 129
Absorption and Excretion by Animals	p. 130
Fate during Manure Storage	p. 134
Releases to the Environment	p. 136
Factors Affecting Dissipation in the Farm Environment	p. 137
Dissipation and Transport in Dung Systems	p. 137
Dissipation and Transport in Soil Systems	p. 138
Biotic Degradation Processes	p. 138
Abiotic Degradation Processes	p. 140
Sorption to Soil	p. 141
Bound Residues	p. 141
Uptake by Plants	p. 143
Models for Estimating the Concentration of Veterinary Medicine in Soil	p. 143
Intensively Reared Animals	p. 144
Pasture Animals	p. 148
PEC Refinement	p. 148
Research Needs	p. 149
References	p. 149
Assessing the Effects of Veterinary Medicines on the Terrestrial Environment	p. 155
Introduction	p. 155
Considerations Unique to Veterinary Medicines	p. 155
Routes of Entry	p. 155
Additional Safety Data Available in the Dossier	p. 156
Residue Data and Detoxification by the Target Animal Species	p. 156
Protection Goals	p. 157
Tiered Testing Strategy	p. 160
Justification for Existing Testing Methods	p. 160
Use of Indicator Species	p. 160
Short-Term and Sublethal Effects Tests	p. 163
Tier A Testing	p. 163
Physicochemical Properties	p. 163
Fate	p. 164
Microorganisms	p. 164
Plants	p. 165
Earthworms	p. 165
Collembolans	p. 166
Dung Fauna	p. 166
Tier B Testing	p. 168
Tier C Testing	p. 169
Mesocosm and Field Testing	p. 169
Testing of Additional Species	p. 170
Monitoring Studies	p. 170
Calculation of PNEC Concentrations and Use of Assessment Factors	p. 171
Metabolite Testing in Tiers A and B	p. 172
Secondary Poisoning	p. 173
Bound Residues	p. 174
Alternative Endpoints	p. 175
Modeling Population and Ecosystem Effects (e.g., Bioindicator Approaches)	p. 176
Research Needs	p. 177
References	p. 177
Workshop Conclusions and Recommendations	p. 181
Workshop Conclusions	p. 181
Workshop Recommendations	p. 184
Index	p. 187
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Veterinary Medicines in the Environment

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