R4 AM Occurrence and Fate of Pharmaceutical and Other Emerging Wastewater Contaminants in Aquatic Systems
Thursday, 17 November 2005: 8:00 AM - 11:40 AM in Ballroom 4

(ERI-1117-809500) Environmental Fate Testing for New Human Pharmaceutical Candidates.

Ericson, J¹, Huggett, D¹, Constantine, L¹, ¹ Pfizer Inc, Pfizer Global R&D, Chemical R&D, Environmental Sciences, Groton, CT, USA

ABSTRACT- Trace levels of pharmaceuticals detected in wastewater effluents and surface waters have raised the level of attention around the ultimate fate and persistence of pharmaceuticals in the environment. The proposed Environmental Risk Assessment (ERA) guidance also brings a base set of testing to characterize water-sediment biodegradation. While the proposed guidance suggests a need for methods focused on the end environment, it is perhaps best characterized when presented in the context of all available data that describes physical properties, propensity to partition into the various environmental compartments and its susceptibility to microbial biotransformation and mineralization as it is transported through wastewater, surface water and sediment compartments. Therefore, a flexible approach is needed in the environmental testing strategy that enables scientists to fully utilize existing information and emerging technologies to better define testing needs that in the end will enhance the overall ERA process and the characterization as to whether something may or may not persist. Pfizer proposes a tiered testing strategy that leverages: 1) available pre-clinical and physical-chemical data in conjunction with environmental models to assess what environmental compartments are of concern; and 2) existing metabolism and pure culture biotransformation data to assess susceptibility to environmental biotransformation and mineralization. This pretest assessment allows one to identify any potential issues with the selected test methods, assess the extent of analytical testing needed to support the sludge, water and sediment methods, and hopefully anticipate some of the outcomes such that when the definitive tests are run the resulting data will be more meaningful and robust.

Key words: environmental, biodegradation, pharmaceuticals, fate