The Environment Agency is the leading public body protecting and. improving the environment in England and Wales , It s our job to make sure that air land and water are looked after by. everyone in today s society so that tomorrow s generations inherit a. cleaner healthier world , Our work includes tackling flooding and pollution incidents reducing. industry s impacts on the environment cleaning up rivers coastal. waters and contaminated land and improving wildlife habitats . This report is the result of research commissioned and funded by the. Environment Agency s Science Programme , Published by Author s . Environment Agency Rio House Waterside Drive Aztec West . Almondsbury Bristol BS32 4UD Alistair B A Boxall Lindsay A Fogg Donald J Baird . Tel 01454 624400 Fax 01454 624409 Chris Lewis Trevor C Telfer Dana Kolpin Anthony Gravell . www environment agency gov uk Emma Pemberton Tatiana Boucard. ISBN 1844325792 Dissemination Status Publicly available. Environment Agency Month Year, All rights reserved This document may be reproduced with prior Keywords veterinary medicines prioritisation modelling . permission of the Environment Agency monitoring, Research Contractor . The views expressed in this document are not necessarily. Cranfield Centre for EcoChemistry Shardlow Derbyshire DE72. those of the Environment Agency , 2GN Tel 01332 799000. This report is printed on Cyclus Print a 100 recycled stock . Environment Agency s Project Managers , which is 100 post consumer waste and is totally chlorine free . Water used is treated and in most cases returned to source in. Tatiana Boucard and Emma Pemberton Wallingford, better condition than removed . Collaborators , Further copies of this report are available from . The Environment Agency s National Customer Contact Centre by. Cranfield University Environment Agency Laboratories. emailing enquiries environment agency gov uk or by. University of Stirling US Geological Survey Central Science. telephoning 08708 506506 , Laboratory, Science Project reference . SC030183, Product code SCHO0806BLHH E P, 2 Targeted monitoring study for veterinary medicines in the environment. Science at the Environment Agency, Science underpins the work of the Environment Agency It provides an up to date understanding. of the world about us and helps us to develop monitoring tools and techniques to manage our. environment as efficiently and effectively as possible . The work of the Environment Agency s Science Group is a key ingredient in the partnership. between research policy and operations that enables the Environment Agency to protect and. restore our environment , The science programme focuses on five main areas of activity . Setting the agenda by identifying where strategic science can inform our evidence based. policies advisory and regulatory roles , Funding science by supporting programmes projects and people in response to long term. strategic needs medium term policy priorities and shorter term operational requirements . Managing science by ensuring that our programmes and projects are fit for purpose and. executed according to international scientific standards . Carrying out science by undertaking research either by contracting it out to research. organisations and consultancies or by doing it ourselves . Delivering information advice tools and techniques by making appropriate products. available to our policy and operations staff ,Steve Killeen. Head of Science, 3 Targeted monitoring study for veterinary medicines in the environment. Executive Summary, Veterinary medicines are widely used to treat disease and to protect the health of. animals Dietary additives may be incorporated into the feed of animals to improve. animal productivity During their use both types of substances have the potential to. be released to the environment , Consequently the marketing authorisation holder provides an environmental. assessment to the licensing authorities as part of the authorisation process A. product is authorised for sale only where the licensing authority is satisfied that the. environmental risk is sufficiently low This study was performed to gain a greater. understanding of the actual concentrations of approved veterinary medicines in the. environment once they are in use The project built upon a previous study funded by. the Environment Agency which brought together data on the usage routes of entry . and the fate and effects of veterinary medicines in use in the UK The information. was used to prioritise these veterinary medicines in use in the UK in terms of their. potential to be released to the environment and their ecotoxicity A list of priority. compounds was developed for further consideration . In the current study this priority list was refined A pragmatic and scientifically sound. risk based ranking approach was developed and applied to each of the compounds. on the priority list in order to gain a greater understanding of the risks they pose to. the environment soil surface water and groundwater relative to others on the list . Using this approach 18 compounds were deemed worthy of monitoring A. monitoring study was performed over an 11 month period to determine. concentrations of seven of the 18 compounds in the UK environment With the. exception of enrofloxacin and its metabolite ciprofloxacin all the study compounds. were detected in one or more environmental compartments see table below . Concentrations of antibacterials in soils ranged from 0 5 g kg 1 trimethoprim to. 305 oxytetracycline g kg 1 Maximum concentrations of antibacterials in water. ranged from 0 02 g kg 1 trimethoprim to 21 1 lincomycin g l 1 the parasiticides. doramectin and ivermectin were not detected Concentrations of antibacterials in. sediment were 0 5 813 g kg 1 and those for doramectin and ivermectin were 2 7. and 4 9 g kg 1 respectively , Maximum measured concentrations were generally lower than predicted no effect. concentrations derived from available ecotoxicity data It is probable that the. average concentrations across the broader UK agricultural landscape will be lower. still for many of the determinands This is because the monitoring programme . considered the highest ranked compounds and scenarios . selected sites with characteristics that would enhance environmental. contamination , focused on occasions when the compounds were likely to be released to the. environment , 4 Targeted monitoring study for veterinary medicines in the environment. The results therefore indicate that in general concentrations of these veterinary. medicines in the UK environment are likely to be below those that could affect. aquatic and terrestrial organisms, However the study did identify some areas where future work is warranted . including , further assessment of the potential impacts of selected medicines on the soil. environment , investigations into the fate and effects of parasiticides in sediment . assessment of those compounds that could not be studied in this project due. to insufficient data , further assessment of the potential impacts of the other 11 of the 18 . selected veterinary medicines on the environment . monitoring of groundwater , Maximum measured environmental concentrations of study veterinary medicines. Faeces litter Soil Water Sediment, g kg 1 g kg 1 g l 1 g kg 1 . ciprofloxacin 0 28 ND ,doramectin 112 ND 2 69,enrofloxacin 2 92 ND . ivermectin pigs 46 1 985 ND ,ivermectin 1 850 ND 4 91. cattle ,lincomycin 8 5 21 1 8 9,oxytetracycline 305 4 49 813. sulfadiazine 0 8 4 13 0 8 ,trimethoprim 0 5 0 02 0 5 . Values are indicative values only , , The treatment dose and duration at study site were significantly higher than recommended so concentrations. under typical treatment regimes are likely to be more than an order of magnitude lower . Concentration around below feeding stations, Targeted monitoring study for veterinary medicines in the environment 5. Contents,Executive Summary 4,Acknowledgements 11,1 Introduction 12. 2 Ranking of priority compounds 15,2 1 Method 15, 2 1 1 Refinement of priority list 16. 2 1 2 Collation of data on usage fate and ecotoxicity 16. 2 1 3 Exposure assessment 17, 2 1 4 Effects assessment 21. 2 1 5 Ranking procedure 21,2 2 Results 22, 2 2 1 Refinement of priority list 22. 2 2 2 Data on usage fate and effects 22, 2 2 3 Exposure assessment 26. 2 2 4 Effect assessment 28, 2 2 5 Risk characterisation 29. 2 3 Summary of the ranking process 39, 3 Monitoring of veterinary medicines in the UK environment 41. 3 1 Site selection 41,3 2 Monitoring 42, 3 2 1 Sampling approaches 42. 3 2 2 Monitoring regimes employed at each site 45. 3 2 3 Analysis 48, 3 2 4 Soil characterisation 50. 3 3 Results 50, 3 3 1 Indoor pigs 50, 3 3 2 Outdoor pigs 53. 3 3 3 Cattle at pasture 54, 3 3 4 Poultry 57,3 4 Summary of field results 57. 4 Discussion 59,5 Conclusions 68,References Bibliography 69. List of acronyms and abbreviations 73, 6 Targeted monitoring study for veterinary medicines in the environment. Appendix 1 Prediction of environmental concentrations 74. Appendix 2 Treatment scenarios used to assess the study compounds 88. Appendix 3 Sorption data for the study compounds 93. Appendix 4 Persistence of the study compounds in manure and soil 94. Appendix 5 Public domain aquatic toxicity data for the priority compounds 795. Appendix 6 Terrestrial toxicity data for the priority compounds 0100. Appendix 7 Terrestrial ranking for the pasture treatments 0107. Appendix 8 Aquatic ranking for pasture treatment scenarios 109. Appendix 9 Groundwater ranking for pasture scenarios 1111. Appendix 10 Terrestrial ranking for intensive treatment scenarios 113. Appendix 11 Aquatic ranking for intensive treatment scenarios 1115. Appendix 12 Groundwater ranking for intensive treatment scenarios 1117. Appendix 13 Soil characteristics 11119, Targeted monitoring study for veterinary medicines in the environment 7. List of figures, Figure 2 1 Approach used to identify priority veterinary medicines for monitoring. Figure 2 2 Schematic of the ranking scheme, Figure 3 1 Measured daily rainfall at the indoor pig scenario monitoring site. Figure 3 2 Concentrations of the study medicines in soil samples taken from a field. treated with slurry from the intensively reared pigs. Figure 3 3 Concentrations of lincomycin oxytetracycline sulfadiazine and. trimethoprim in stream water during the study period. Figure 3 4 Concentrations of the study medicines in sediment samples taken from. a stream adjacent to a field treated with pig slurry. Figure 3 5 Concentrations of ivermectin in soil samples obtained from outside the. feeding stations and around below the feeding stations at the outdoor. pig farm, Figure 3 6 Concentrations of doramectin in faecal material collected from the. outdoor cattle farm, Figure 3 7 Concentrations of doramectin in stream sediment. Figure 3 8 Concentrations of ivermectin in faecal material obtained from the. outdoor cattle site, Figure 3 9 Concentrations of ivermectin in sediment obtained from the outdoor. cattle site, 8 Targeted monitoring study for veterinary medicines in the environment. List of tables, Table 1 1 High risk compounds subjected to full risk characterisation. Table 1 2 High risk compounds requiring further data for full risk characterisation. Table 2 1 Assessment factors used to derive aquatic PNECs. Table 2 2 Assessment factors used to derive terrestrial PNECs. Table 2 3 Veterinary medicines removed from or added to the priority list. Table 2 4 List of priority compounds for further assessment. Table 2 5 Sorption and persistence data used in the ranking process. Table 2 6 Predicted TWA concentrations in soil and surface water and maximum. predicted groundwater concentrations for the study compounds used to. treat pasture animals, Table 2 7 Predicted TWA concentrations in soil and surface water and maximum. predicted groundwater concentrations for the study compounds used to. treat intensively reared livestock, Table 2 8 Predicted maximum concentrations in receiving waters for the three. priority compounds used in aquaculture during and 24 hours after. treatment, Table 2 9 Terrestrial ecotoxicity data and PNECs for the study compounds. Table 2 10 Aquatic ecotoxicity data and PNECs for the study compounds. Table 2 11 Priority compounds and scenarios identified for pasture animals i e . those compounds and scenarios with an RCR 1 or a concentration in. groundwater 0 1 g l 1 listed in order of increasing RCR or. PECgroundwater , Table 2 12 Priority compounds and scenarios identified for intensively reared. animals i e those compounds and scenarios with an RCR 1 or a. concentration in groundwater 0 1 g l 1 listed in order of increasing. RCR or PECgroundwater , Table 2 13 Compounds identified as of potential concern for inclusion in the. targeted monitoring programme, Table 3 1 Treatment scenarios used at the monitoring sites. Table 3 2 Veterinary medicines selected for monitoring. Targeted monitoring study for veterinary medicines in the environment 9. Table 3 3 Maximum measured environmental concentrations of study veterinary. medicines, Table 4 1 Comparison of modelled treatment scenarios with actual treatments. used on the monitored farms, Table 4 2 Comparison of maximum measured concentrations in surface waters. with PNECs, Table 4 3 Comparison of maximum measured concentrations in soils with PNECs. 10 Targeted monitoring study for veterinary medicines in the environment. Acknowledgements, The authors would like to acknowledge the assistance of the Veterinary Medicines. Directorate and members of the National Office of Animal Health NOAH in the. project , In particular we would like to thank Dr Paul Cooper Dr Audrey Kelly Dr Mark Crane . Mr Stephen Dawson Mr John Fitzgerald Dr Peter Jones Mrs Carol Long Professor. Randolph Richards and Dr Alex Tait , Targeted monitoring study for veterinary medicines in the environment 11. 1 Introduction, Veterinary medicines are widely used to treat disease and to protect the health of. animals Some dietary additives are also incorporated into the feed of animals reared. for food in order to improve their productivity Compounds used include parasiticides . antibiotics and antifungals Feed additives are not veterinary medicines and are. authorised under different legislation Most of the compounds considered in this study. are authorised as veterinary medicines but a few are authorised as feed additives . For simplicity the term veterinary medicine is used in this report to cover both . Through its chemicals strategy Managing Chemicals for a Better Environment. Environment Agency 2003 the Environment Agency aims to focus its activities on. those chemicals most likely to affect the environment This can only be achieved if. the release and subsequent potential effects of these chemicals are understood . During their use veterinary medicines have the potential to be released to the. environment Consequently the marketing authorisation holder provides an. environmental assessment to the licensing authorities as part of the authorisation. process A product is authorised for sale only where the licensing authority is satisfied. that the environmental risk is sufficiently low This study was performed to gain a. greater understanding of the actual concentrations of approved veterinary medicines. in the environment once they are in use , Releases of veterinary medicines to the environment may occur directly e g where. they are used in fish farms and indirectly via the application of animal manure. containing excreted products to land A number of groups of veterinary medicines. have been well studied and their risks to the environment are relatively well. understood these are primarily , sheep dip chemicals Environment Agency 1998 2000 2001 SEPA 2000 . fish farm medicines Jacobsen and Berglind 1988 Davies et al 1998 . anthelmintics Wall and Strong 1987 McCracken 1993 Ridsill Smith 1993 . Strong 1993 McKellar 1997 , However there are scant data available in the public domain on the potential. environmental impacts of other groups of veterinary medicines . To gain a greater understanding of the impacts on the environment arising from the. use of veterinary medicinal products the Environment Agency commissioned a. review of all available information on veterinary medicines in the environment Boxall. et al 2002 2004 The review considered , current regulatory mechanisms. current usage, likely exposure routes, environmental fate and behaviour. environmental effects , 12 Targeted monitoring study for veterinary medicines in the environment. This review highlighted the large number and wide variety of veterinary medicines in. use and found that with the exception of a few groups of compounds limited. information is available in the public domain on potential environmental impacts . To identify compounds of possible concern a prioritisation scheme was developed as. part of this earlier study to assess the relative potential for veterinary medicines and. feed additives to cause environmental harm The scheme was based on the potential. for the compound to reach the environment in significant amounts and a simple. assessment of hazard using the toxicity data given by Boxall et al 2002 2004 . This scheme enabled those compounds likely to be of greatest potential concern to. be identified using this approach a total of 55 compounds were assigned to a high. risk category However there was only sufficient data available to fully characterise. the potential risk for the 11 compounds listed in Table 1 1 . Table 1 1 High risk compounds subjected to full risk characterisation. Compound Treatment scenario s that pose a high risk . Amoxicillin herd and aquaculture,Apramycin herd,Chlortetracycline herd. Cypermethrin herd,Diazinon herd,Dihydrostreptomycin herd. Oxytetracycline herd and aquaculture,Sarafloxacin aquaculture. Sulfadiazine aquaculture,Tetracycline herd,Tylosin herd. The 44 remaining compounds identified as potentially high priority but requiring. further data are listed in Table 1 2 , Table 1 2 High risk compounds requiring further data for full risk. characterisation ,Trimethoprim Morantel Enrofloxacin. Baquiloprim Flumethrin Dimethicone,Amprolium Triclabendazole Poloxalene. Clopidol Fenbendazole Toltrazuril,Lasalocid sodium Levamisole Decoquinate. Maduramicin Ivermectin Diclazuril,Nicarbazin Cephalexin Phosmet . Robenidine hydrochloride Florfenicol Piperonyl butoxide. Procaine penicillin Tilmicosin Amitraz, Procaine benzylpenicillin Oxolinic acid Deltamethrin. Clavulanic acid Lido lignocaine Cyromazine,Monensin Tiamulin Emamectin benzoate. Salinomycin sodium Lincomycin Immunological products. Flavophospolipol Clindamycin,Neomycin Nitroxynil, Ranked in column form on the basis of annual usage . No longer marketed , This prioritisation scheme was designed as a screening tool and was therefore. simplistic in nature for example it did not consider dissipation and transport in the. Targeted monitoring study for veterinary medicines in the environment 13. environment and no information was provided on which environmental compartments. e g soil surface water groundwater and air were most likely to be exposed . The Environment Agency therefore commissioned this follow on study in order to . refine the prioritisation exercise , investigate further those compounds identified as being of greatest potential to. cause harm to gain greater understanding of the risks they pose to the. environment soil surface water and groundwater relative to other. compounds on the priority list , develop and perform a targeted environmental monitoring programme to. ascertain whether those compounds identified as posing the greatest risk are. present in the environment at ecologically significant levels . This work will inform the Environment Agency s approach to these compounds It will. help to ensure that the monitoring programme is effectively targeted identify the. need if any for pollution prevention measures and guide future research initiatives . Section 2 of this report describes the refinement of the prioritisation exercise and the. development and application of a ranking scheme to identify the relative risks posed. to the environment following the use of the priority compounds as either livestock or. aquaculture treatments , Section 3 describes the performance of a targeted monitoring study to generate. information on concentrations of seven of the highest ranked compounds in the UK. environment Section 4 offers a general discussion of the results while the overall. conclusions are drawn in Section 5 , 14 Targeted monitoring study for veterinary medicines in the environment. 2 Ranking of priority compounds, The screening based approach described in Section 1 prioritised compounds based. on information on usage and available ecotoxicity data However the approach was. qualitative and did not consider how a compound is likely to behave in the. environment , This study was therefore undertaken to refine the previous approach by developing a. ranking scheme that incorporated information on , different treatment scenarios for an active substance . environmental fate and effects, The aim was to identify those medicines and treatment scenarios with the greatest. potential to cause harm and which thus warrant further study The scenarios and. compounds identified were considered of interest for inclusion in a targeted risk . based monitoring programme see Section 3 ,2 1 Method. The ranking was performed in a number of discrete stages Figure 2 1 . In the first stage the priority list from the previous Environment Agency project. Boxall et al 2002 was reviewed and refined to ensure that it was up to date . accurate and reflected current regulatory concerns Information on the usage fate. and effects of each of the compounds on the refined priority list was then collated and. used to estimate their concentrations in the main environmental compartments . Predicted no effect concentrations were calculated from available ecotoxicity data . By comparing predicted environmental concentrations PECs with predicted no . effect concentrations PNECs it was possible to rank compounds and treatment. types in terms of their potential to cause harm for the environmental compartments. soil surface water and sediment Impacts on groundwaters were assessed solely on. the basis of concentration i e compounds of potential environmental concern were. those with maximum environmental concentrations predicted to exceed 0 1 g l 1 the. current limit for pesticides in drinking water An outline of the scheme is given in. Figure 2 2 , The aim of the scheme was not to characterise the risks posed by each compound. individually this is already done during the authorisation of its use but to determine. the level of risk associated with the use of a particular compound in relation to others. on the priority list This approach allowed those compounds with a higher potential to. cause harm to be identified , Targeted monitoring study for veterinary medicines in the environment 15.
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