Use of models for the environmental risk assessment of veterinary medicines in European aquaculture: Current situation and future perspectives
Rico, Andreu ; Vighi, Marco ; Brink, Paul J. van den; Horst, Mechteld ter; Macken, Ailbhe ; Lillicrap, Adam ; Falconer, Lynne ; Telfer, Trevor C. - \ 2019
Reviews in Aquaculture 11 (2019)4. - ISSN 1753-5123 - p. 969 - 988.
Antimicrobials - Antiparasitics - Aquaculture - Environmental models - Environmental risk assessment
Veterinary Medicinal Products (VMPs) are used in intensive aquaculture production to treat a wide range of bacterial and parasitic infestations. Their release into the environment poses concerns regarding their potential ecotoxicological risks to aquatic ecosystems, which need to be evaluated making use of appropriate Environmental Risk Assessment (ERA) schemes and models. This study presents an overview of the major aquaculture production systems in Europe, the VMPs most commonly used, and the environmental quality standards and regulatory procedures available for their ERA. Furthermore, it describes the state-of-the-art on the development of environmental models capable of assessing the fate, exposure, ecotoxicological effects and risks of VMPs in aquaculture production systems, and discusses their level of development and implementation within European aquaculture. This study shows that the use of environmental models in regulatory ERA is somewhat limited in many European countries. Major efforts have been dedicated to assess the fate and exposure of antiparasitic compounds in salmonid cage systems, particularly in Scotland, while models and scenarios for assessing dispersal of antimicrobials, in general, and antiparasitic compounds in the Mediterranean as well as in Scandinavian regions are less available. On the other hand, the use of ecological models for assessing the effects and risks of VMPs is almost absent. Recommendations are provided to improve the chemical exposure and effect assessments and the ecological realism of the modelling outcomes, paying special attention to the protection goals set for the regulatory ERA of VMPs in Europe.
A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment
Scholz, S. ; Sela, E. ; Blaha, L. ; Braunbeck, T. ; Galay-Burgos, M. ; Garcia-Franco, M. ; Guinea, J. ; Kluver, N. ; Schirmer, K. ; Tanneberger, K. ; Tobor-Kaplon, M. ; Witters, H. ; Belanger, S. ; Benfenati, E. ; Creton, S. ; Cronin, M.T.D. ; Eggen, R.I.L. ; Embry, M. ; Ekman, D. ; Gourmelon, A. ; Halder, M. ; Hardy, B. ; Hartung, T. ; Hubesch, B. ; Jungmann, D. ; Lampi, M.A. ; Lee, L. van; Leonard, M. ; Kuster, E. ; Lillicrap, A. ; Luckenbach, T. ; Murk, A.J. ; Navas, J.M. ; Peijnenburg, W. ; Repetto, G. ; Salinas, E. ; Schuurmann, G. ; Spielmann, H. ; Tollefsen, K.E. ; Walter-Rohde, S. ; Whale, G. ; Wheeler, J.R. ; Winter, M.J. - \ 2013
Regulatory Toxicology and Pharmacology 67 (2013). - ISSN 0273-2300 - p. 506 - 530.
zebrafish danio-rerio - plant-protection products - messenger-rna expression - adverse outcome pathways - acute fish toxicity - in-vitro - toxicological concern - disrupting chemicals - aquatic toxicity - aromatic-hydrocarbons
Tests with vertebrates are an integral part of environmental hazard identification and risk assessment of chemicals, plant protection products, pharmaceuticals, biocides, feed additives and effluents. These tests raise ethical and economic concerns and are considered as inappropriate for assessing all of the substances and effluents that require regulatory testing. Hence, there is a strong demand for replacement, reduction and refinement strategies and methods. However, until now alternative approaches have only rarely been used in regulatory settings. This review provides an overview on current regulations of chemicals and the requirements for animal tests in environmental hazard and risk assessment. It aims to highlight the potential areas for alternative approaches in environmental hazard identification and risk assessment. Perspectives and limitations of alternative approaches to animal tests using vertebrates in environmental toxicology, i.e. mainly fish and amphibians, are discussed. Free access to existing (proprietary) animal test data, availability of validated alternative methods and a practical implementation of conceptual approaches such as the Adverse Outcome Pathways and Integrated Testing Strategies were identified as major requirements towards the successful development and implementation of alternative approaches. Although this article focusses on European regulations, its considerations and conclusions are of global relevance