United States Environmental Protection Agency Office of Research and Development National Exposure Research Laboratory Research Abstract Government Performance Results Act Goal: Safe Food Significant Research Findings: A Second-Generation Multimedia, Multipathway Exposure Model Scientific Problem Accurately quantifying human exposures and doses of various and Policy Issues populations to environmental pollutants is critical for the U. S. Environmental Protection Agency (EPA) to assess and manage human health risks. For example, the Food Quality Protection Act (FQPA) of 1996 requires the EPA to consider aggregate human exposure to a pesticide, especially for infants and children, when setting regulatory limits on that pesticide's usage. Pesticides and metals are several examples of pollutants that can be present in multiple environmental media (air, water, soil, house dust, food, surface residues) and that can contact a human via various routes and pathways. These routes and pathways include dietary ingestion of pesticide residues in food and drinking water, inhalation of air containing pesticides, dermal (skin) contact with surfaces containing pesticides (indoors and residential lawns), and non-dietary ingestion of pesticide residues from hand- or object-to-mouth activities. Estimation of the population's exposure from dietary ingestion and inhalation is difficult because of the lack of information on the patterns of human activities and food consumption, limited knowledge of the contaminant levels in food, and challenges in determining breathing rates for different levels of human activity. Dermal and non-dietary exposure pathways are even more challenging to quantify because many difficult-to-measure factors (such as the frequency of contact with contaminated surfaces, the subsequent transfer of the pesticide residue from those surfaces, and the frequency of putting fingers and objects into one's mouth) influence an individual's exposure. These issues result in both variability of exposures to individuals within a population and uncertainty in exposure estimates. Aggregate exposure refers to the total exposure of humans to a single chemical through multiple environmental media and pathways. The EPA's Office of Research and Development (ORD), National Exposure Research Laboratory (NERL) has developed a probabilistic model that predicts the range and distribution of aggregate personal exposures and doses within a population as well as the uncertainty in the model estimates. This model is called the Stochastic Human Exposure and Dose Simulation Model, or SHEDS model. National Exposure Research Laboratory — October 2001 ------- Research Approach The primary objective of this research is to develop a computerized model to conduct assessments of aggregate human exposures and doses for various populations and multimedia, multipathway pollutants. The model framework is being developed with an initial case study for the pesticide chlorpyrifos and the population of young children. Chlorpyrifos has been widely used both in homes and on food crops, and is associated with multiple media and pathways of human exposure. The SHEDS model for pesticides (SHEDS-Pesticides) is being developed in stages. The first generation SHEDS-Pesticides focused on children's exposure and absorption on a single day post-pesticide application via dermal contact with and non-dietary ingestion of surface residues in and around the home. Distributions of exposure and mass of 3,5,6 -trichloro-2-pyridinol (TCP, a metabolite of chlorpyrifos) in blood and eliminated in urine were modeled for different residential uses of chlorpyrifos, different periods of time after its usage, and different age groups of children that might be exposed. The results were then combined with a probabilistic, multimedia, multipathway exposure model and chlorpyrifos assessment developed as part of the National Human Exposure Assessment Survey (NHEXAS). The second-generation aggregate SHEDS model for pesticides extends the first generation model by including the inhalation and dietary ingestion routes in addition to dermal contact and non-dietary ingestion. It also allows for characterization of uncertainty as well as variability in predicted population estimates of exposure and dose. The algorithms used to estimate exposure via the various routes and pathways have also been refined. The refined model can simulate an individual's exposure up to a year time frame, accounting for multiple pesticide applications in the residential environment, in addition to single day estimates for different post-application time periods. In addition, a user-friendly interface has been developed for the aggregate SHEDS-Pesticides model with both exposure researchers and regulators in mind as potential users. Results and Initial results of the second generation SHEDS-Pesticides suggest that Implications for those exposed, dermal contact and non-dietary ingestion routes are the most important for shorter times after application (e.g., days to weeks) and that food ingestion and inhalation are the most significant routes for longer times post-application (e.g., weeks to months). High variability in modeled estimates primarily reflects differences in activities among individuals and differences in the concentrations contacted by individuals during their daily activities. Uncertainty in the model results stems from the lack of data for critical factors including National Exposure Research Laboratory — October 2001 ------- information on pesticide usage, the pattern and frequency of touching surfaces, hand-to-mouth and object-to-mouth activity patterns, pesticide residue concentrations at different post-application times, pesticide residue transfer to the skin surface upon contact, where people spend their time in relation to where pesticide residues exist in the residential environment, and factors related to intake and uptake into the human body after exposure. As more exposure measurements data become available and iterative sensitivity and uncertainty analyses are conducted, uncertainties in model results will be reduced. By the same token, as model development progresses, SHEDS will continue to help refine the identification of areas of greatest uncertainty that need more research. This project directly supports ORD's research to improve the scientific foundation of human health risk assessment under the Government Performance and Results Act (GPRA) Goal 8.2, annual performance measure (APM) 216 ("Develop a second generation aggregate exposure model (SHEDS) for pesticides that characterizes uncertainty and variability in model inputs and outputs"). It will help the program offices improve the risk assessment and risk management processes by providing more realistic exposure assessment methods than currently used screening level methods. The SHEDS-Pesticides model will help users test hypotheses and formulate appropriate designs for exposure measurement studies. This work also directly addresses GPRA Goal 3.2.4 (Safe Food, Research to Support New Regulatory Requirements under FQPA). The probabilistic modeling approach used by SHEDS-Pesticides can aid in the determination of whether for a given pesticide "there is a reasonable certainty that no harm will result from aggregate exposures to the pesticide's chemical residue from all anticipated dietary sources as well as all exposures from other sources for which there are reliable information," as required by FQPA. SHEDS will help to improve the quantification of infants and children's exposure and dose to pesticides and provide a framework for identifying and prioritizing measurement needs under FQPA. The revisions to the model are intended to address the needs of EPA's Office of Pesticide Programs (OPP) regarding FQPA. A scientist-to-scientist meeting co-sponsored by ORD NERL and OPP in October 2001 is being held to compare and contrast the five aggregate residential pesticide exposure models, including SHEDS, that are being developed to address OPP's needs to address FQPA. The results of this workshop should include future directions of both modeling and measurements research in the area of aggregate human exposure assessment. National Exposure Research Laboratory — October 2001 ------- The second generation multimedia, multipathway SHEDS modeling project was conducted primarily by a team of NERL staff scientists. OPP has provided technical input on model development, especially on the dietary module and planning for the model comparison meeting. Contractor assistance in writing computer programs was provided by ManTech Environmental Technology, Inc. This research has been presented in several international and national conference presentations, and in the following manuscripts: Zartarian, V.G., Ozkaynak, H., Burke, J.M., Zufall, M.J., Rigas, M.L., and Furtaw, E.J..Jr. "A Modeling Framework for Estimating Children's Residential Exposure and Dose to Chlorpyrifos via Dermal Residue Contact and Non- Dietary Ingestion." Environmental Health Perspectives, 108(6), (2000). Buck, R.J., Ozkaynak, H., Xue, J., Zartarian, V.G., Hammerstrom, K. "Modeled Estimates of Chlorpyrifos Exposure and Dose for the Minnesota and Arizona NHEXAS Populations," accepted J Expos. Anal. Environ Epid., (2001). Future Research The second-generation multimedia, multipathway exposure model described here is part of a larger on-going effort to develop models that improve our understanding of the routes, pathways, and factors that contribute to pollutant exposure and dose, especially to infants and children. Work is being conducted to refine the dose aspects of the model using the dose estimating exposure model being developed in NERL (Exposure Related Dose Estimating Model, ERDEM). That research coupled with SHEDS-Pesticides will allow better simulation of the body's uptake, metabolism, and elimination of pesticides. Additional exposure pathways such as contact with residues on pets and the track-in of pesticides into the home on shoes and clothing will also be included in refinements to SHEDS-Pesticides, and new measurements data will be used to refine the model inputs and evaluate the model outputs. After the aggregate SHEDS-Pesticides model has been evaluated, SHEDS will be extended to address cumulative exposure and dose to multiple pollutants with similar health endpoints. Questions and inquiries can be directed to: Haluk Ozkaynak, Ph.D. US EPA, Office of Research and Development National Exposure Research Laboratory Research Triangle Park, NC 27711 Phone: 919/541-5172 E-mail: ozkaynak.haluk@epa.gov Research Collaboration and Publications Contacts for Additional Information National Exposure Research Laboratory — October 2001 ------- |