World Congress on Risk 2015
19-23 July, 2015, Singapore

Online Program



Session Schedule & Abstracts


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Common abbreviations

Monday 20-07-2015

M4-E
Pharmaceutical Risk Assessment: Pieces of the "PiE"

Room: Exploration   14:00–15:30

Chair(s): Frederic Leusch



0    Pharmaceutical Risk Assessment: Pieces of the ‘PiE’. Duchemin M, Biological Laboratory Services , DHI Water and Environment; Choi K, Seoul National University; Oldenkamp R, Radboud University; Leusch F, Griffith University   willis@tera.org (91)

Abstract: This session will bring together academics, regulators, and industry with expertise in pharmaceuticals and environmental risk assessment areas. The focus of this session is environmental impacts of pharmaceuticals and regulatory approaches to minimizing these impacts, with a focus on impacts to developing countries. This session will bring together different pieces of risk assessment for pharmaceuticals in the environment (PiE). We have invited speakers from the local area in Singapore, as well as speakers from across the globe. The goal is to recruit speakers from multiple fields to present diverse perspectives in this area, as possible. Currently we have three confirmed speakers, Matthieu Duchemin who is a senior ecotoxicologist from Singapore, Kyungho Choi who is an environmental toxicologist from Seoul National University, and Rik Oldenkamp who is faculty of environmental sciences at Radboud University in the Netherlands. We are currently seeking to solidify a fourth speaker, and have approached several others along these lines, including a few industry groups to get a holistic perspective. Presentations and Session Focus Each speaker will present in the area of their expertise, under the pharmaceuticals in the environment (PiE) and risk assessment topic. The goal is to have at least one speaker looking at regulatory approaches in this area in developing countries and elsewhere, and to have one or two looking at environmental effects and exposures. The fourth talk could be focused on global issues, the integration of human health risk and environmental risk, or other related topics. Dr. Matthieu Duchemin focuses in Product Safety and Environmental Risk Assessment regarding Ballast Water Treatment testing, Whole Effluent Toxicity testing, chemical regulations, oilfield chemicals, metal and metal compounds, etc. In charge of business development in APAC, building up technical capacities (resources and facilities), interacting with all others DHI market areas and experts (climate change, flooding, renewable energy, etc.). Dr. Kyungho Choi will be able to present on Environmental risk assessment of pharmaceuticals – Experiences and regulatory perspectives of Korea. His topic will be related to pharmaceuticals in the environment. Significant amounts of research have been conducted in this area but there are still knowledge gaps regarding their environmental risks and needs for being regulated. The main results of the 5 year risk assessment program of Korea on environmental pharmaceuticals will be presented. In addition, existing regulatory programs of Korea that are associated with environmental health aspects of pharmaceuticals will be identified, and the directions for future management in Korea will be suggested. For environmental risk assessment of pharmaceuticals, target pharmaceuticals based on their environmental occurrences were identified along with then-available toxicity information. Hazard quotients (HQ) were derived for 22 pharmaceutical compounds. We also found that standardized toxicity testing methods might not be appropriate for understanding the real ecological impact of pharmaceuticals. Environmental risks of veterinary pharmaceuticals should also be further evaluated especially in the areas near concentrated animal feeding operations. Currently, several ministries of Korea implement regulations on various aspects of pharmaceuticals. These ministries include Ministry of Agriculture, Food and Rural Affairs (MAFRA), Ministry of Health and Welfare (MHW), and Ministry of Food and Drug Safety (MFDS). However, the environmental risks of pharmaceuticals, neither on registration stage and after use, are neither properly assessed nor managed under the current regulatory structure. Considering potential risk implications of pharmaceuticals in environment, actions are needed to better understand the need for and if needed the directions of the regulations. Rik Oldenkamp’s research focuses on probabilistic risk assessment for a selection of antineoplastics and antibiotics for human health and the aquatic ecosystem. This includes: the identification of realistic worst-case human and ecological exposure scenarios for pharmaceuticals; the development of new risk assessment endpoints to integrate probabilistic human and ecological risk assessment of pharmaceuticals; and the development and/or application of new methods and/or models to perform probabilistic human and ecological risk assessment for pharmaceuticals, with the possible inclusion of mixture and indirect effects. He plans to focus his presentation on the spatially explicit risk assessment of human pharmaceuticals, following the consecutive stages of emission, fate, exposure, and effect, while integrating the assessment of both human and aquatic risks. Due to their characteristics as down-the-drain chemicals, human pharmaceuticals show emission patterns that can be derived from country-specific data on consumption, and geographical information on population density and locations of sewage treatment plants. Via the incorporation of chemical-specific removal efficiencies for a range of sewage treatment techniques, and information on country-specific sludge disposal, such spatial emission patterns were estimated for the aquatic environment and agricultural soils throughout Europe. These emission patterns were subjected to multimedia fate calculations based on local environmental characteristics. The resulting concentration estimations were used for the assessment of both aquatic and human risks, the latter after incorporation of chemical-specific accumulation rates into different foodstuffs, drinking water purification data, and location-specific food consumption patterns. This methodology has been applied for purposes of ranking and prioritization of exposure scenarios in a regulatory setting. Additionally, when based on defined daily doses (DDDs) instead of country-specific consumption data, the methodology can be used to compare the local impact of two alternative pharmaceutical prescriptions. As such, it provides physicians with the opportunity to include environmental considerations in their choice of prescription. A fourth speaker yet to be identified will focus on some of the remaining issues in this area, relating to risk communication, global perspectives of risk, or integration of human health risk assessment.

1    Environmental risk assessment of pharmaceuticals and management challenges in Korea. Choi K    (112)

Abstract: Pharmaceuticals in environment have been demonstrated for various ecological damages, and of global environmental health concern. Regulatory landscapes for this important group of chemicals vary by country. In this presentation, the main results of the first stage of the 5 year risk assessment program of Korea on environmental pharmaceuticals (2008-2012) and the successive second stage program (2013-2014) are reported. In addition, existing regulatory programs of Korea that are associated with environmental health aspects of pharmaceuticals are identified, and the directions for future management in Korea are suggested. For environmental risk assessment of pharmaceuticals, we identified target pharmaceuticals based on their environmental occurrences and then-available toxicity information. Among twenty two pharmaceuticals that were identified, fenbendazole, followed by neomycin, mefenamic acid, ibuprofen, and chlortetracycline were found to have relatively higher hazard quotients (HQ), but none was higher than one. We found that standardized toxicity testing methods might not be appropriate for understanding real ecological impact of pharmaceuticals. Low concentration long term exposure and mixture scenario are among the conditions that should be considered for evaluation of environmental risks of pharmaceuticals. Environmental risks of veterinary pharmaceuticals should be further evaluated especially for the areas near concentrated animal feeding operations. Currently, three ministries of Korea implement regulations on various aspects of pharmaceuticals. However, the environmental risks of pharmaceuticals, both on registration stage and after use, are neither properly assessed nor managed under the current regulatory structure. Considering potential risk implications of pharmaceuticals in environment, actions are needed to better understand the need and to establish proper regulations.

2    Spatially explicit prioritisation of human pharmaceuticals in Europe. Oldenkamp R    (116)

Abstract: Active pharmaceutical ingredients (APIs) have been detected in a wide range of environmental media. Even though reported at low concentrations, their specific mode of action makes APIs a group of substances of potential concern. Policy makers are struggling with the so-called ‘who-what-where?’ question: what substances can cause significant risks for what exposure groups at what locations? We developed a method for the spatially explicit risk assessment of human APIs, following the consecutive stages of emission, fate, exposure and effect, while integrating the assessment of human and aquatic risks. As down-the-drain chemicals, their emission patterns can be derived from country-specific data on consumption, and geographical data on population density, locations and designs of sewage treatment plants (STPs). Spatial emission patterns were estimated for the aquatic environment and agricultural soils throughout Europe, and were subjected to multimedia fate calculations based on local environmental characteristics. The resulting concentration estimations were used for the assessment of aquatic and human risks, the latter after incorporation of chemical-specific accumulation rates into different foodstuffs, drinking water purification data, and location-specific food consumption patterns. The methodology was illustrated for a set of 11 human antibiotics and 7 antineoplastics. Aquatic risk quotients were highest for levofloxacin, doxycycline and ciprofloxacin, located in Northern Italy (Milan region) and other densely populated areas in Europe (e.g. London, Krakow and the Ruhr area). Risk quotients for human health not only depend on API and location, but also on behavioural characteristics such as consumption patterns. Additionally, when based on defined daily doses (DDDs) instead of country-specific consumption data, the methodology was used to compare the local impact of two alternative API prescriptions. As such, it provides physicians with the opportunity to include environmental considerations in their choice of prescription.

3    Medicating the environment: pharmaceuticals in waste, surface and drinking water - an Australian perspective. Leusch F, Griffith University   f.leusch@griffith.edu.au (254)

Abstract: Pharmaceuticals are reported in both surface and urban waters worldwide in increasing frequency, the combined result of growing human and agricultural use and our ability to detect lower concentrations. While a significant amount of toxicity data is generated during drug development, most of that data are closely guarded by pharmaceutical companies and unavailable to environmental scientists or regulators, making conventional risk assessment difficult. This presentation will provide an overview of our current understanding of the risk posed by pharmaceuticals in Australia, in the context of both ecological and human health. Several studies have been published in recent years to allow a rough estimate of the ecological risk to be calculated. The data shows that wastewater treatment significantly mitigates the potential risk, but that some pharmaceuticals are occasionally still present at concentrations above predicted no effect concentrations (PNEC) in treated wastewater. Increased urbanisation and occasional severe droughts have led to intermittent scarcity of drinking water supply in most Australian capital cities in the past decade. The water sector has thus had to consider alternative water supplies, including water recycling, which require both advanced water reclamation processes and a new regulatory framework. A new approach was developed to calculate drinking water guidelines for pharmaceuticals in the 2008 Australian Guidelines for Water Recycling. The framework is based on the lowest daily therapeutic dose (LDTD) and includes additional uncertainty factors to account for interactions and specific effects, and allows to prioritise pharmaceuticals based on their risk quotient (RQ). There are still many gaps that hamper a comprehensive risk assessment of pharmaceuticals in environmental and urban waters in Australia, but lessons learned in the Australian context can help fast-track prioritisation and risk assessment in other countries.

4    Information Gaps in the Measurement of Atrazine Exposure in Pregnant Women and Risk of Adverse Birth Outcomes. Parvezs S, Indiana University; Winchester P, St. Francis Hospital   parvezs@iu.edu (306)

Abstract: Among the various drinking water contaminants, pesticides group is the leading source of public health concern particularly for sensitive population such as pregnant women and newborns. Among different types of pesticides, Atrazine herbicide is the most commonly reported pesticide in drinking water supply, particularly in the area with high agricultural activities such as mid-west United States. Atrazine exposure in pregnant women is unknown but suspected to cause complications during pregnancy such as preeclampsia, preterm labor, abruption, chorioamnionitis, miscarriage, abortion, birth defects, preterm birth, and intra-uterine growth restriction. Limited number of epidemiological and animal studies have reported an increase risk of congenital birth defects in rural population but other studies from low environmental exposure remain inconclusive in urban population. Atrazine exposure assessment is challenged by no monitoring data, high treatment cost, unavailability of sensitive chemical method, no toxicity data on metabolites, and difficulty in quantifying congenital defects. In our presentation, we will discuss the key challenges researchers face in the exposure assessments of Atrazine for association with birth outcomes. Also, qualitative recommendations will be made for advancing our understanding on Atrazine exposure in pregnant women to better inform regulators and public health scientists.



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