A comparative evaluation of environmental risk assessment strategies for pharmaceuticals and personal care products

• The US and EU are the only entities that have well-defined existing ERAs for PPCPs.
• Japan is developing an approach for the ERA of PPCPs.
• Data generated by different ERA protocols for PPCPs deliver inconsistent results.
• US and EU ERA methods may understate the effect of PPCPs on ecosystem health.
• A finely honed ERA procedure is needed ensure effective regulation of PPCPs.

With the increased concern of potential threats triggered by the occurrence of pharmaceuticals and personal care products (PPCPs) in the environment, environmental risk assessment (ERA) strategies for such compounds have considerably evolved over the past decade. Regulations are in effect or planned in several developed countries, however, there is no global standard for conducting ERAs. A review of guidelines developed by the United States Food and Drug Administration (US FDA), European Union European Medicines Evaluation Agency (EU EMEA), and Japan are presented in this paper. The methods of each protocol are compared and contrasted, thereby highlighting the strengths and weaknesses of each approach. To further assess the effectiveness of these ERAs, each protocol was carried out using actual concentrations of sulfamethoxazole (SMZ), a common sulfonamide used as an antibiotic in animals and humans, detected in four US bays. The protocols produce conflicting results regarding the possible influence of SMZ in the selected coastal environments.