Regulatory approval of veterinary medicinal products requires an assessment of the potential exposures to and effects on ecological receptors for these compounds in the environment. Banamine Transdermal Pour-On for Beef and Dairy Cattle contains the active pharmaceutical ingredient (API) flunixin, which is a non-steroidal anti-inflammatory drug (NSAID). Avian receptors, in particular old world vultures, have been shown to be vulnerable to related APIs (namely diclofenac) after feeding on tissue from treated livestock. Furthermore, specific routes of exposures for birds to pesticides topically applied to livestock have been identified, reporting impacts to magpies after consuming hair from cattle treated with the organophosphate famphur and secondary poisoning of raptors consuming affected magpies. These two factors – potential effects of NSAIDs on birds and previously observed avian exposure through cattle hair ingestion – triggered a focus on assessing risks to avian in addition to mammalian receptors in the environmental assessment (EA) for Banamine Transdermal. The following exposure pathways were evaluated: predatory and scavenging birds and mammals consuming tissues from treated cattle, birds that may perch on the backs of cattle and ingest treated hair, and secondary poisoning of predatory and scavenging birds and mammals (i.e. by consumption of birds that have ingested treated cattle hair). Innovative approaches included the experimental determination of the amount of cattle hair that can fit into the magpie gizzard, the use of US EPA’s Wildlife Exposure Factors Handbook to derive species-specific information, and assessment of the risk to magpies on a population basis. Results from this assessment demonstrated that the use of Banamine Transdermal is not expected to cause any significant impacts on avian or mammalian receptors. The environmental assessment performed by FDA supports the sponsor’s finding that Banamine Transdermal, when used as directed, has no significant adverse impact on the human environment.

Innovative approaches for assessing risk to wildlife from the use of a veterinary medicinal product in cattle

254th National Meeting (2017)

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