Veterinary medicines in the environment: from the SETAC Pellston workshop on veterinary medicines in the environment, Pensacola, Florida, USA, 12-16 February 2006

226 Pages·2009·2.08 MB·English

by  Mark Crane, Alistair B A Boxall, Katie Barrett, SETAC Pellston Workshop on Veterinary Medicines in the Environment, O. Seifert

Veterinary Medicines
in the Environment
Other Titles from the Society of Environmental Toxicology
and Chemistry (SETAC)
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E
Veterinary Medicines
in the Environment
Edited by
Mark Crane
Alistair B. A. Boxall
Katie Barrett
From the SETAC Pellston Workshop on
Veterinary Medicines in the Environment
Pensacola, Florida, USA
12–16 February 2006
Coordinating Editor of SETAC Books
Joseph W. Gorsuch
Gorsuch Environmental Management Services, Inc.
Webster, New York, USA
Boca Raton London New York
CRC Press is an imprint of the
Taylor & Francis Group, an informa business
Information contained herein does not necessarily reflect the policy or views of the Society of Environ-
mental Toxicology and Chemistry (SETAC). Mention of commercial or noncommercial products and
services does not imply endorsement or affiliation by the author or SETAC.
Published in collaboration with the Society of Environmental Toxicology and Chemistry (SETAC)
1010 North 12th Avenue, Pensacola, Florida 32501
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SETAC Publications
Books published by the Society of Environmental Toxicology and Chemistry
(SETAC) provide in-depth reviews and critical appraisals on scientifc subjects rel-
evant to understanding the impacts of chemicals and technology on the environment.
The books explore topics reviewed and recommended by the Publications Advisory
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Board of Directors; the SETAC Europe Council; or the SETAC World Council for
their importance, timeliness, and contribution to multidisciplinary approaches to
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the series refect the wide range of disciplines encompassed by environmental tox-
icology, environmental chemistry, and hazard and risk assessment, and life-cycle
assessment. SETAC books attempt to present the reader with authoritative coverage
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SETAC recognizes and thanks the past coordinating editors of SETAC books:
A.S. Green, International Zinc Association
Durham, North Carolina, USA
C.G. Ingersoll, Columbia Environmental Research Center
US Geological Survey, Columbia, Missouri, USA
T.W. La Point, Institute of Applied Sciences
University of North Texas, Denton, Texas, USA
B.T. Walton, US Environmental Protection Agency
Research Triangle Park, North Carolina, USA
C.H. Ward, Department of Environmental Sciences and Engineering
Rice University, Houston, Texas, USA
Contents
List of Figures ....................................................................................................xiii
List of Tables ....................................................................................................... xv
About the Editors ..............................................................................................xvii
Workshop Participants .......................................................................................xix
Foreword ............................................................................................................xxi
Acknowledgments ............................................................................................. xxv
Chapter 1 Introduction ..................................................................................... 1
Mark Crane, Katie Barrett, and Alistair Boxall
References ............................................................................................................. 3
Chapter 2 Uses and Inputs of Veterinary Medicines in the Environment ....... 7
Alistair Boxall, Mark Crane, Christian Corsing, Charles Eirkson,
and Alex Tait
2.1 Introduction ................................................................................................ 7
2.2 Veterinary Medicine Use ........................................................................... 7
2.2.1 Parasiticides .................................................................................... 8
2.2.2 Antibacterials .................................................................................. 8
2.2.3 Coccidiostats and Antiprotozoals ................................................. 10
2.2.4 Antifungals ................................................................................... 10
2.2.5 Aquaculture Medicines ................................................................. 10
2.2.6 Hormones ...................................................................................... 10
2.2.7 Growth Promoters ......................................................................... 10
2.2.8 Other Medicinal Classes ............................................................... 11
2.3 Pathways to the Environment ................................................................... 11
2.3.1 Emissions during Manufacturing and Formulation ...................... 11
2.3.2 Aquaculture ................................................................................... 12
2.3.3 Agriculture (Livestock Production) .............................................. 13
2.3.4 Companion and Domestic Animals .............................................. 14
2.3.5 Disposal of Unwanted Drugs ........................................................ 15
2.4 Summary .................................................................................................. 16
References ........................................................................................................... 17
Chapter 3 Environmental Risk Assessment and Management of
Veterinary Medicines .................................................................... 21
Joop de Knecht, Tatiana Boucard, Bryan W. Brooks, Mark Crane,
Charles Eirkson, Sarah Gerould, Jan Koschorreck, Gregor Scheef,
Keith R. Solomon, and Zhixing Yan
vii
viii Contents
3.1 Introduction .............................................................................................. 21
3.2 Veterinary Medicines in Regulatory Perspective .................................... 23
3.2.1 Legislation, Scope, and Past Guidelines for Environmental
Risk Assessment (ERA) of Veterinary Medicines ....................... 23
3.2.1.1 United States ................................................................... 24
3.2.1.2 European Union .............................................................. 25
3.2.1.3 Japan ................................................................................ 26
3.2.1.4 Australia .......................................................................... 26
3.2.1.5 Canada ............................................................................. 26
3.2.2 Current Guidelines: VICH and the VICH–EU Technical
Guidance Document (VICH–EU–TGD) ...................................... 27
3.3 Refnement of Veterinary Medicinal Product (VMP) Risk Assessments ..... 33
3.3.1 Metabolism and Degradation ........................................................ 33
3.3.2 Combination Products ................................................................... 35
3.3.3 Refnement of Environmental Exposure Predictions .................... 36
3.3.4 Probabilistic Risk Assessment of Veterinary Medicines .............. 36
3.3.4.1 Case Study of a Probabilistic Risk Assessment for
Dung Fauna ..................................................................... 37
3.4 Risk Management .................................................................................... 41
3.4.1 Risk Mitigation Measures within Product Authorization or
Approval........................................................................................ 42
3.4.2 Risk Assessment and Management beyond Authorization or
Approval........................................................................................ 44
3.4.2.1 Communication Challenge .............................................. 44
3.4.2.2 Incidence Reporting and Pharmacovigilance ................. 47
3.4.3 Retrospective Risk Assessment .................................................... 49
3.4.4 Postmarket Monitoring and Remediation ..................................... 51
3.4.4.1 Monitoring Endpoints ..................................................... 51
References ........................................................................................................... 52
Chapter 4 Exposure Assessment of Veterinary Medicines in Aquatic
Systems .......................................................................................... 57
Chris Metcalfe, Alistair Boxall, Kathrin Fenner, Dana Kolpin, Mark Servos,
Eric Silberhorn, and Jane Staveley
4.1 Introduction .............................................................................................. 57
4.2 Sources of Veterinary Medicines in the Aquatic Environment ............... 58
4.2.1 Treatments Used in Agriculture .................................................... 58
4.2.2 Treatments Used in Aquaculture .................................................. 61
4.3 Experimental Studies into the Entry, Fate, and Transport of
Veterinary Medicines in Aquatic Systems ............................................... 62
4.3.1 Aquatic Exposure to Veterinary Medicines Used to Treat
Livestock ....................................................................................... 62
4.3.1.1 Leaching to Groundwater ................................................ 63
4.3.1.2 Movement to Surface Water ............................................ 63
Contents ix
4.3.1.3 Predicting Exposure ........................................................ 65
4.3.1.4 Comparison of Modeled Concentrations with
Measured Concentrations ................................................ 66
4.3.2 Aquaculture Treatments ................................................................ 73
4.3.2.1 Inputs and Fate of Marine Aquaculture Treatments ....... 75
4.3.2.2 Freshwater Aquaculture .................................................. 76
4.3.2.3 Modeling Exposure from Aquaculture Treatments......... 77
4.4 Conclusions .............................................................................................. 89
References ........................................................................................................... 91
Chapter 5 Assessing the Aquatic Hazards of Veterinary Medicines ............. 97
Bryan W. Brooks, Gerald T. Ankley, James F. Hobson, James M. Lazorchak,
Roger D. Meyerhoff, and Keith R. Solomon
5.1 Introduction .............................................................................................. 97
5.2 Protection Goals ....................................................................................... 98
5.3 Approaches to Assess Effects of Veterinary Medicines .......................... 98
5.3.1 Current Methods of Assessing Aquatic Effects for Risk
Assessment .................................................................................... 98
5.3.1.1 Lower Tier Approaches ................................................... 99
5.3.1.2 Higher Tier Testing ......................................................... 99
5.3.1.3 Limitations to Current Approaches ................................101
5.3.2 Novel Approaches to Aquatic Effects Assessment ..................... 102
5.3.2.1 Use of Chemical Characteristics, Target Organism
Effcacy Data, Toxicokinetic Data, and Mammalian
Toxicology Data ............................................................ 102
5.3.2.2 Use of Ecotoxicogenomics in Ecological Effects
Assessment .................................................................... 108
5.4 Application Factors and Species Sensitivities .........................................110
5.5 Effects of Veterinary Medicines in the Natural Environment ................113
5.5.1 Episodic Exposures ......................................................................114
5.5.2 Matrix Effects ..............................................................................114
5.5.3 Metabolites and Degradates .........................................................115
5.5.4 Mixtures .......................................................................................116
5.5.5 Enantiomer-Specifc Hazard ........................................................117
5.5.6 Sorption to Sediment ...................................................................118
5.5.7 Assessing Effects on Communities..............................................119
5.6 Conclusions ............................................................................................ 121
References ......................................................................................................... 122
Chapter 6 Exposure Assessment of Veterinary Medicines in Terrestrial
Systems ........................................................................................ 129
Louise Pope, Alistair Boxall, Christian Corsing, Bent Halling-Sørensen,
Alex Tait, and Edward Topp