Scientific Publications by FDA Staff

Integr Environ Assess Manag 2011 Apr;7(2):287-96

How to test nontarget effects of veterinary pharmaceutical residues in livestock dung in the field.

Jochmann R, Blanckenhorn WU, Bussiere L, Eirkson CE, Jensen J, Kryger U, Lahr J, Lumaret JP, Rombke J, Wardhaugh KG, Floate KD

To register veterinary medicinal products (VMPs) as parasiticides on pastured animals, legislation in the European Union requires an environmental risk assessment to test the potential nontarget effects of fecal residues on dung-dwelling organisms. Products with adverse effects in single-species laboratory tests require further, higher-tier testing to assess the extent of these effects on entire communities of dung-dwelling organisms under more realistic field or semifield conditions. Currently, there are no documents specifically written to assist researchers in conducting higher-tier tests or to assist regulators in interpreting the results of such tests in an appropriate context. Here we provide such a document, written by members of the SETAC Advisory Group DOTTS (Dung Organism Toxicity Testing Standardization) with research experience on dung fauna in central and southern Europe, Canada, Australia, and South Africa. This document briefly reviews the organisms that make up the dung community and their role in dung degradation, identifies key considerations in the design and interpretation of experimental studies, and makes recommendations on how to proceed.