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Publications: Human Pharmaceuticals

Papers & ReportsHome and Personal Care Products, Human Pharmaceuticals, Water/Wastewater Assessments2015

A framework for screening sites at risk from contaminants of emerging concern

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Trace levels of a variety of currently unregulated organic chemicals have been detected in treated wastewater effluents and surface waters that receive treated effluents. Many of these chemicals of emerging concern (CECs) originate from pharmaceuticals and personal care products that are used widely and that frequently are transported “down the drain” to a wastewater treatment plant (WWTP). Actual effects of CECs on aquatic life have been difficult to document, although biological effects consistent with effects of some CECs have been noted. There is a critical need to find appropriate ways to screen wastewater sites that have the greatest potential of CEC risk to biota. Building on the work of several researchers, the authors present a screening framework, as well as examples based on the framework, designed to identify high‐risk versus lower‐risk sites that are influenced by WWTP effluent. It is hoped that this framework can help researchers, utilities, and the larger water resource community focus efforts toward improving CEC risk determinations and management of these risks.

Diamond, J., Munkittrick, K., Kapo, K.E., Flippin, J. (2015), A framework for screening sites at risk from contaminants of emerging concern. Environ Toxicol Chem. 34: 2671-2681. doi:10.1002/etc.3177

PresentationsHuman Pharmaceuticals2017

Understanding the Fate of Chemicals in Land Applied Materials Using Multi-Scale Field Studies

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SETAC Session Title:  Pharmaceuticals in the Environment: Potential Environmental and Human Health Impacts
Presentation Date: Thursday November 16, 2017
Presentation Time: 8:20 PM
Location: Session Room 101AJ

Contaminants of emerging concern (including pharmaceuticals) are often reported in aquatic monitoring studies. A direct pathway into the environment is via discharge into rivers, if not fully removed during wastewater treatment. However, for some substances, a large fraction may be removed in the wastewater treatment process in the form of sludge. An additional pathway can occur when the sludge is land-applied as biosolids, with movement to surface water if overland runoff or erosion occurs. To understand the potential environmental exposure resulting from runoff or erosion of biosolids, field scale runoff studies real-world provide exposure data. The direct measurement of runoff and erosion under controlled field settings can be used to inform exposure modeling, to explore mitigation evaluation, and ultimately refine estimated environmental concentration calculations. Multi-plot small-scale runoff studies (ft2) can rapidly test multiple application and vegetation scenarios under simulated rainfall. These studies can also integrate a variety of soil and slope conditions. Larger landscape scale runoff studies (ftto acres) assess greater variability and may incorporate subunit environmental fate investigations. Studies at this larger scale are designed to utilize simulated or natural rainfall. Both small- and large-scale study designs produce total and flow dependent mass loading data to assess the fraction of applied chemical which is transported under defined conditions. Watershed scale runoff studies (acres to mi2) are designed to evaluate broader land use and the effect on surface water quality. Stream loading, hydrologic, and land use data are generated to fully understand the impacts that temporally or spatially distributed environmental variables may have on results. The time scale for these monitoring studies span from sub-day to multi-year. Although runoff studies conducted under USEPA Good Laboratory Practice Standards have been used for many years to support pesticide risk assessment, these types of studies can be readily applied to measure transport and fate of any land applied chemical for ultimate use in environmental risk assessment.

Les Carver, Jennifer Trask, Nathan Snyder, Greg Goodwin, Megan Cox and Daniel Perkins (Waterborne Environmental). Understanding the Fate of Chemicals in Land Applied Materials Using Multi-Scale Field Studies. Platform SETAC 2017. Minneapolis, MN.

PostersHuman Pharmaceuticals2015

Framework for Addressing Bioaccumulation Potential of Human Pharmaceuticals

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PRESENTATION DATE: Thursday, November 5, 2015

LOCATION: Exhibit Hall


The potential for human pharmaceuticals to bioaccumulate in aquatic organisms is rapidly becoming an area of scientific and regulatory interest. Historically, bioaccumulation assessments are conducted after consideration of a chemical’s hydrophobicity (e.g. Kow). The current strategy for determining the bioaccumulation potential of a human pharmaceutical is identical in scope in that scientists are required to conduct an OECD 305 fish study if the Kow value of a given pharmaceutical is greater than a prescribed regulatory trigger value (e.g. Log Kow> 4). The physical-chemical knowledge (e.g. pKa) of the compound should be incorporated into this initial Kow assessment to better guide the need for a full “B” assessment. In many instances, the current strategy does not utilize the wealth of non-clinical and clinical data available on the absorption, disposition, metabolism and elimination (ADME) of the pharmaceutical of interest, which could be used to better inform scientists on important characteristics and physiological processes associated with that human pharmaceutical. It is important to recognize that fish have the ability to perform many of the same physiological processes that mammals perform, hence a pharmaceutical’s ADME characteristics could be similar in fish. These data can be used to understand the ability of a fish to absorb, distribute, biotransform and eliminate a human pharmaceutical. If needed, studies can be conducted utilizing methodologies widely used on the drug development process (e.g. in vitro metabolism assays) to understand the similarity between fish and mammals and better guide the testing overall strategy. By utilizing all the available information collected and methodologies employed during the drug development process of a human pharmaceutical, scientists can make a more informed decision regarding the need for bioaccumulation testing (i.e. OECD 305), potentially reduce the number of vertebrate animals used in laboratory studies and achieve an overall cost savings.

Duane Huggett, Nikki Maples-Reynolds, Waterborne Environmental. “Framework for Addressing Bioaccumulation Potential of Human Pharmaceuticals”. SETAC Salt Lake City November 2015.

PresentationsHome and Personal Care Products, Human Pharmaceuticals2014

Recent Developments in Exposure Modeling of “Down-the-Drain“ Chemicals Across Multiple Product Groups

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To promote product stewardship and regulatory compliance for chemical suppliers and manufacturers of formulated home and personal care products, an environmental fate model, iSTREEM®, was created. Although iSTREEM® is owned by the American Cleaning Institute, its capabilities expand beyond cleaning products. Any chemical that will be disposed of “down-the-drain” can be modelled with this application, including those in personal care products, pharmaceuticals and home use pesticides and disinfectants.

iSTREEM® is a web-based publicly available computer model (www.istreem.org) that calculates the concentration of chemicals from consumer products disposed of “down-the-drain” in the influent and effluent of more than 10,000 municipal wastewater treatment plants in the United States. In addition, the concentrations can be calculated in receiving streams at the point of effluent discharge (mixing zone), downstream of effluent discharge, and at the point of drinking water intake for more than 25,000 river reaches in the U.S.

Recently, iSTREEM® was expanded to include densely populated portions of Southern Ontario in Canada. By adding the Lower St. Lawrence watershed to the model, examination of the complete Great Lakes watershed is now possible.

A description of the process for acquisition and management of the Canadian datasets for flow of effluent-impacted streams in Southern Ontario and the relevant facilities (wastewater treatment plants and drinking water plants) will be provided. Particular emphasis will be given to the development of the flow data, and corroboration of the concentration data generated by simulation with local monitoring data for relevant chemicals.

Katherine E. Kapo, Chris Holmes, Raghu Vamshi, Paul DeLeo, Darci Ferrer. Recent Developments in Exposure Modeling of “Down-the-Drain“ Chemicals Across Multiple Product Groups. SETAC NA, 2014 platform.

PostersHome and Personal Care Products, Human Pharmaceuticals, Industrial and Specialty Chemicals2014

Tools for Probabilistic Environmental Exposure Assessment of “Down-The-Drain” Chemicals in The U.S.

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Environmental exposure assessment of down-the-drain chemicals (home and personal care products, pharmaceuticals, etc.) is strongly dependent upon the in-stream dilution of receiving waters, which varies by geography and flow conditions. In this study, the iSTREEM® model (www.istreem.org, American Cleaning Institute) was utilized to delineate probabilistic distributions of practical dilution factors (flow-based as well as incorporating varying chemical biodegradation rates) in mean and low flow conditions, as well as the national distribution of per capita domestic wastewater production. The distributions yielded by this work can serve as a reference for probabilistic exposure assessments for down-the-drain chemicals in wastewater treatment plant (WWTP) mixing zones and at drinking water intakes in the conterminous U.S. In addition, an assessment of treatment processes based on the WWTP facilities within the iSTREEM model provided an assessment of the proportion of wastewater flow volume treated by various processes (activated sludge, lagoon, etc.). The ability to quantitatively evaluate waste water production, treatment, and dilution in a spatial context provides a practical and powerful tool for assessing exposure and risk of down-the-drain chemicals of various types.

Katherine E. Kapo, Kathleen McDonough, Tom Federle, Scott D. Dyer, Raghu Vamshi, Chris M. Holmes. Tools for Probabilistic Environmental Exposure Assessment of “Down-The-Drain” Chemicals in The U.S. SETAC North America 35th Annual Meeting, Vancover, B.C. November 14, 2014.