Environmental risk assessment of ivermectin:  A case study

Markus Liebig; Alvaro Alonso Fernandez; Elke Blübaum-Gronau; Alistair Boxall; Marvin Brinke; Gregoria Carbonell; Philipp Egeler; Kathrin Fenner; Carlos Fernandez; Guido Fink; Jeanne Garric; Bent Halling-Sørensen; Thomas Knacker; Kristine A Krogh; Anette Küster; Dirk Löffler; Miguel Angel Porcel Cots; Louise Pope; Carsten Prasse; Jörg Römbke; Ines Rönnefahrt; Manuel K Schneider; Natascha Schweitzer; José V Tarazona; Thomas A Ternes; Walter Traunspurger; Anne Wehrhan; Karen Duis

doi:10.1002/ieam.96

Environmental risk assessment of ivermectin: A case study

Markus Liebig, Alvaro Alonso Fernandez, Elke Blübaum-Gronau, Alistair Boxall, Marvin Brinke, Gregoria Carbonell, Philipp Egeler, Kathrin Fenner, Carlos Fernandez, Guido Fink, Jeanne Garric, Bent Halling-Sørensen, Thomas Knacker, Kristine A Krogh, Anette Küster, Dirk Löffler, Miguel Angel Porcel Cots, Louise Pope, Carsten Prasse, Jörg RömbkeInes Rönnefahrt, Manuel K Schneider, Natascha Schweitzer, José V Tarazona, Thomas A Ternes, Walter Traunspurger, Anne Wehrhan, Karen Duis

Environment and Geography

Research output: Contribution to journal › Article › peer-review

Abstract

The veterinary parasiticide ivermectin was selected as a case study compound within the project ERAPharm (Environmental Risk Assessment of Pharmaceuticals). Based on experimental data generated within ERAPharm and additional literature data, an environmental risk assessment (ERA) was performed mainly according to international and European guidelines. For the environmental compartments surface water, sediment, and dung, a risk was indicated at all levels of the tiered assessment approach. Only for soil was no risk indicated after the lower tier assessment. However, the use of effects data from additional 2-species and multispecies studies resulted in a risk indication for collembolans. Although previously performed ERAs for ivermectin revealed no concern for the aquatic compartment, and transient effects on dung-insect populations were not considered as relevant, the present ERA clearly demonstrates unacceptable risks for all investigated environmental compartments and hence suggests the necessity of reassessing ivermectin-containing products. Based on this case study, several gaps in the existing guidelines for ERA of pharmaceuticals were shown and improvements have been suggested. The action limit at the start of the ERA, for example, is not protective for substances such as ivermectin when used on intensively reared animals. Furthermore, initial predicted environmental concentrations (PECs) of ivermectin in soil were estimated to be lower than refined PECs, indicating that the currently used tiered approach for exposure assessment is not appropriate for substances with potential for accumulation in soil. In addition, guidance is lacking for the assessment of effects at higher tiers of the ERA, e.g., for field studies or a tiered effects assessment in the dung compartment.

Original language	English
Pages (from-to)	567-87
Number of pages	21
Journal	Integrated Environmental Assessment and Management
Volume	6 Suppl
Issue number	SUPPL. 1
DOIs	https://doi.org/10.1002/ieam.96
Publication status	Published - Jul 2010

Keywords

Animals
Antiparasitic Agents
Environmental Monitoring
Environmental Pollutants
Guidelines as Topic
Ivermectin
Risk Assessment
Soil
Time Factors
Water

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Liebig, M., Fernandez, A. A., Blübaum-Gronau, E., Boxall, A., Brinke, M., Carbonell, G., Egeler, P., Fenner, K., Fernandez, C., Fink, G., Garric, J., Halling-Sørensen, B., Knacker, T., Krogh, K. A., Küster, A., Löffler, D., Cots, M. A. P., Pope, L., Prasse, C., ... Duis, K. (2010). Environmental risk assessment of ivermectin: A case study. Integrated Environmental Assessment and Management, 6 Suppl(SUPPL. 1), 567-87. https://doi.org/10.1002/ieam.96

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title = "Environmental risk assessment of ivermectin: A case study",

abstract = "The veterinary parasiticide ivermectin was selected as a case study compound within the project ERAPharm (Environmental Risk Assessment of Pharmaceuticals). Based on experimental data generated within ERAPharm and additional literature data, an environmental risk assessment (ERA) was performed mainly according to international and European guidelines. For the environmental compartments surface water, sediment, and dung, a risk was indicated at all levels of the tiered assessment approach. Only for soil was no risk indicated after the lower tier assessment. However, the use of effects data from additional 2-species and multispecies studies resulted in a risk indication for collembolans. Although previously performed ERAs for ivermectin revealed no concern for the aquatic compartment, and transient effects on dung-insect populations were not considered as relevant, the present ERA clearly demonstrates unacceptable risks for all investigated environmental compartments and hence suggests the necessity of reassessing ivermectin-containing products. Based on this case study, several gaps in the existing guidelines for ERA of pharmaceuticals were shown and improvements have been suggested. The action limit at the start of the ERA, for example, is not protective for substances such as ivermectin when used on intensively reared animals. Furthermore, initial predicted environmental concentrations (PECs) of ivermectin in soil were estimated to be lower than refined PECs, indicating that the currently used tiered approach for exposure assessment is not appropriate for substances with potential for accumulation in soil. In addition, guidance is lacking for the assessment of effects at higher tiers of the ERA, e.g., for field studies or a tiered effects assessment in the dung compartment.",

keywords = "Animals, Antiparasitic Agents, Environmental Monitoring, Environmental Pollutants, Guidelines as Topic, Ivermectin, Risk Assessment, Soil, Time Factors, Water",

author = "Markus Liebig and Fernandez, {Alvaro Alonso} and Elke Bl{\"u}baum-Gronau and Alistair Boxall and Marvin Brinke and Gregoria Carbonell and Philipp Egeler and Kathrin Fenner and Carlos Fernandez and Guido Fink and Jeanne Garric and Bent Halling-S{\o}rensen and Thomas Knacker and Krogh, {Kristine A} and Anette K{\"u}ster and Dirk L{\"o}ffler and Cots, {Miguel Angel Porcel} and Louise Pope and Carsten Prasse and J{\"o}rg R{\"o}mbke and Ines R{\"o}nnefahrt and Schneider, {Manuel K} and Natascha Schweitzer and Tarazona, {Jos{\'e} V} and Ternes, {Thomas A} and Walter Traunspurger and Anne Wehrhan and Karen Duis",

year = "2010",

month = jul,

doi = "10.1002/ieam.96",

language = "English",

volume = "6 Suppl",

pages = "567--87",

journal = "Integrated Environmental Assessment and Management",

issn = "1551-3793",

publisher = "SETAC Press",

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Liebig, M, Fernandez, AA, Blübaum-Gronau, E, Boxall, A, Brinke, M, Carbonell, G, Egeler, P, Fenner, K, Fernandez, C, Fink, G, Garric, J, Halling-Sørensen, B, Knacker, T, Krogh, KA, Küster, A, Löffler, D, Cots, MAP, Pope, L, Prasse, C, Römbke, J, Rönnefahrt, I, Schneider, MK, Schweitzer, N, Tarazona, JV, Ternes, TA, Traunspurger, W, Wehrhan, A & Duis, K 2010, 'Environmental risk assessment of ivermectin: A case study', Integrated Environmental Assessment and Management, vol. 6 Suppl, no. SUPPL. 1, pp. 567-87. https://doi.org/10.1002/ieam.96

TY - JOUR

T1 - Environmental risk assessment of ivermectin

T2 - A case study

AU - Liebig, Markus

AU - Fernandez, Alvaro Alonso

AU - Blübaum-Gronau, Elke

AU - Boxall, Alistair

AU - Brinke, Marvin

AU - Carbonell, Gregoria

AU - Egeler, Philipp

AU - Fenner, Kathrin

AU - Fernandez, Carlos

AU - Fink, Guido

AU - Garric, Jeanne

AU - Halling-Sørensen, Bent

AU - Knacker, Thomas

AU - Krogh, Kristine A

AU - Küster, Anette

AU - Löffler, Dirk

AU - Cots, Miguel Angel Porcel

AU - Pope, Louise

AU - Prasse, Carsten

AU - Römbke, Jörg

AU - Rönnefahrt, Ines

AU - Schneider, Manuel K

AU - Schweitzer, Natascha

AU - Tarazona, José V

AU - Ternes, Thomas A

AU - Traunspurger, Walter

AU - Wehrhan, Anne

AU - Duis, Karen

PY - 2010/7

Y1 - 2010/7

N2 - The veterinary parasiticide ivermectin was selected as a case study compound within the project ERAPharm (Environmental Risk Assessment of Pharmaceuticals). Based on experimental data generated within ERAPharm and additional literature data, an environmental risk assessment (ERA) was performed mainly according to international and European guidelines. For the environmental compartments surface water, sediment, and dung, a risk was indicated at all levels of the tiered assessment approach. Only for soil was no risk indicated after the lower tier assessment. However, the use of effects data from additional 2-species and multispecies studies resulted in a risk indication for collembolans. Although previously performed ERAs for ivermectin revealed no concern for the aquatic compartment, and transient effects on dung-insect populations were not considered as relevant, the present ERA clearly demonstrates unacceptable risks for all investigated environmental compartments and hence suggests the necessity of reassessing ivermectin-containing products. Based on this case study, several gaps in the existing guidelines for ERA of pharmaceuticals were shown and improvements have been suggested. The action limit at the start of the ERA, for example, is not protective for substances such as ivermectin when used on intensively reared animals. Furthermore, initial predicted environmental concentrations (PECs) of ivermectin in soil were estimated to be lower than refined PECs, indicating that the currently used tiered approach for exposure assessment is not appropriate for substances with potential for accumulation in soil. In addition, guidance is lacking for the assessment of effects at higher tiers of the ERA, e.g., for field studies or a tiered effects assessment in the dung compartment.

AB - The veterinary parasiticide ivermectin was selected as a case study compound within the project ERAPharm (Environmental Risk Assessment of Pharmaceuticals). Based on experimental data generated within ERAPharm and additional literature data, an environmental risk assessment (ERA) was performed mainly according to international and European guidelines. For the environmental compartments surface water, sediment, and dung, a risk was indicated at all levels of the tiered assessment approach. Only for soil was no risk indicated after the lower tier assessment. However, the use of effects data from additional 2-species and multispecies studies resulted in a risk indication for collembolans. Although previously performed ERAs for ivermectin revealed no concern for the aquatic compartment, and transient effects on dung-insect populations were not considered as relevant, the present ERA clearly demonstrates unacceptable risks for all investigated environmental compartments and hence suggests the necessity of reassessing ivermectin-containing products. Based on this case study, several gaps in the existing guidelines for ERA of pharmaceuticals were shown and improvements have been suggested. The action limit at the start of the ERA, for example, is not protective for substances such as ivermectin when used on intensively reared animals. Furthermore, initial predicted environmental concentrations (PECs) of ivermectin in soil were estimated to be lower than refined PECs, indicating that the currently used tiered approach for exposure assessment is not appropriate for substances with potential for accumulation in soil. In addition, guidance is lacking for the assessment of effects at higher tiers of the ERA, e.g., for field studies or a tiered effects assessment in the dung compartment.

KW - Animals

KW - Antiparasitic Agents

KW - Environmental Monitoring

KW - Environmental Pollutants

KW - Guidelines as Topic

KW - Ivermectin

KW - Risk Assessment

KW - Soil

KW - Time Factors

KW - Water

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U2 - 10.1002/ieam.96

DO - 10.1002/ieam.96

M3 - Article

C2 - 20821718

SN - 1551-3793

VL - 6 Suppl

SP - 567

EP - 587

JO - Integrated Environmental Assessment and Management

JF - Integrated Environmental Assessment and Management

IS - SUPPL. 1

ER -

Environmental risk assessment of ivermectin: A case study

Abstract

Keywords

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