Data on exposure to multiple chemicals within and between chemical classes can be assessed to. Biomonitoring equivalents can be used for evaluation of biomonitoring data in a risk assessment context. Human biomonitoring data collection from occupational. The use of human biomonitoring data in a risk assessment is feasible if it is determined that a biomarker of exposure is specific and sensitive, such that concentrations measured reflect exposure to the substance of interest.
Although exposure biomarkers should reflect a persons exposure to the target chemicals or their precursors within a specific timeframe, timing. We present a case study using diethyl phthalate and di2ethylhexyl phthalate as examples to illustrate scientific approaches and their limitations, identify data gaps, and outline research needs for using biomonitoring data in the context of human health risk assessment, with an emphasis on exposure and dose. Exa 408 interpreting biomonitoring data and using pharmacokinetic modeling in exposure assessment widespread acceptance and use of the cdcs national health and nutritional examination survey nhanes database, which, among other things, reports measured concentrations of environmental contaminants in blood and urine, has led to an expanded. Biomonitoring studies of environmental stressors are useful for confirming exposures, estimating dose levels, and evaluating human health risks. Use of the pbpk model coupled with typical exposure scenarios provides the strongest scientific foundation for chlorpyrifos human health risk assessment and is the approach used in this 2016 assessment. Ideally, it describes the sources, routes, pathways, and uncertainty in the assessment. See ipcs, 2004 glossary of key exposure assessment terminology pdf 122 pp, 951 k, about pdf. Learn where chemicals are found and ways to reduce exposure. Guidance for the interpretation of biomonitoring data. Human biomonitoring study results are published as reports text pdf together with background information about the chemical analytes. In addition, biomonitoring data generated from outside canada may also be used. Human exposure assessment to environmental chemicals.
Exposure information department of toxic substances control. Guidance for the interpretation of biomonitoring data b. Biomarker data, gathered through biomonitoring, can strengthen exposure assessment. The use of biomonitoring data in exposure and human health. While personal care products, food packaging and other consumer conveniences have improved some. Summary human biomonitoring for environmental chemicals. The present document is published complying with the transparency principle to which the authority is subject. Pdf the role of human biological monitoring in health risk. Comments from the natural resources defense council re. In this document, an updated sourcetooutcome continuum is presented to better define biomarkers as.
Guidance is also provided on presenting the results of the exposure assessment and characterizing uncertainty. Few chemicals are in that data rich category lead and mercury are two. Nov 01, 2006 although the availability of human biomonitoring data for many chemicals can greatly reduce the uncertainty associated with the use of external exposure estimates in risk assessment, experience and guidance are needed to integrate the use of biomonitoring data into the risk assessment process. Biomonitoringbased indicators of exposure to chemical pollutants. Hbm can be applied to the different steps of risk assessment, but its obvious core role lies within human exposure assessment. The potential for the formation of a reactive metabolite at high exposures as noted above suggests that more than one biomarker could be measured. It also presents firsttime exposure information for 75 of the 212 chemicals included in the report. Biomonitoring data are now widely used in studies of health outcomes to identify or understand potential relationships between exposure and responses. The present document is published complying with the transparency principle to.
Exposure to phthalates is considered to be potentially harmful to human health as well. Harmonizing analytical chemistry and clinical epidemiology for human biomonitoring studies. Pdf the use of biomonitoring data in exposure and human. The importance of study design and sampling protocols from inception of an exposure assessment study cannot be overstated, not only for ensuring accurate data is produced, but also for prospective studies that recognize how analytical capacity and. This would enable monitoring of the effectiveness of the legally binding international agreement on mercury, the minamata convention, as well as related parma commitments. Biomonitoring programmes are useful for investigating human exposure to environmental chemicals. The data are analyzed separately by age, sex and raceethnicity groups. However, depending on the intended use, biomonitoring, like all exposure tools, may not be a standalone exposure assessment tool for some. Interpreting biomonitoring data in a risk assessment context. Data were obtained from assessments of the flame retardants prepared by united states u. Guidance for biomonitoring programs 3 preamble public health professionals, policy makers and the public are increasingly concerned about human exposure to chemicals in our environment.
Human biomonitoring can be an effective tool for assessing exposure to a variety of chemicals. Evaluation of biomonitoring data from the cdc national. Uses of human biomonitoring data in risk assessment. Exposure values are not predefined, or outlined for risk assessment. National research council published a report, human biomonitoring for environmental chemicals. We discuss some factors relevant for interpreting and understanding biomonitoring data, including selection of both biomarkers of exposure and human matrices, and toxicokinetic information. Mar 08, 2017 the present document has been produced and adopted by the bodies identified above as authors. Increasing focus on subtle biological alterations, population risks. Parks will establish a comprehensive program of worker exposure assessment using qualified industrial hygienists and park employees who have been trained as workplace monitors. One of these programmes, the national health and nutrition examination survey nhanes, conducted annually in the united states by the centers for disease control and prevention cdc is designed to collect data on the health and nutritional status of the non. Integration of omics and hts data, individual genetic susceptibility. The biomonitoring data are available as part of the nhanes dataset, which can be obtained from cdc.
National biomonitoring program new and improved, highquality biomonitoring methods for priority environmental chemicals. It is the process of estimating an external exposure to a chemical that is consistent with and based. Biomonitoring for environmental chemicals in human biological media has become an indispensible feature of the chemical risk assessment landscape. Use of biomonitoring data in conjunction with other appropriate health and environmental. In this document, an updated sourcetooutcome continuum is presented to better. Information on human exposure can then be linked to data on sources and epidemiological surveys, in order to inform research on the exposure. A survey of risk assessment practitioners on the extent to which biomarkers are used in risk assessment concluded that the absence of chemicalspecific data for example, toxicologic and epidemiologic data was the primary limitation in using exposure biomarkers in risk assessment maier et al.
Among the techniques that can be used for exposure assessment, biomonitoring is increasingly becoming one of the most popular choices. Fourth report 2009 cdc pdf pdf 530 pages summarizes cdcs national health and nutrition examination survey nhanes biomonitoring data from 19992004. Comparing biomonitoring data for a chemical with its biomonitoring equivalent provides a means for assessing whether population exposures to chemicals are within or above the levels considered safe by regulatory agencies. Harmonizing analytical chemistry and clinical epidemiology. Chemicals in the second national report on human exposure to environmental chemicals lead. Nov 01, 2006 the applicability of biomonitoring data for perfluorooctanesulfonate to the environmental public health continuum. However, the complexities of exposure biomarker and biomarkerresponse relationships have limited the use of biomarkers in exposure science studies. Rate exposure assessment modules exa 408, exa 409 science. Integrating biomonitoring exposure data into the risk assessment process. Acropolis contributes to the development of a methodology to ensure that the missing aspects in the risk assessment of pesticides can be addressed in future risk management. Despite the existence of human biomonitoring programmes at national level and the large number of research and development projects ongoing both at national and european union level, there is a clear lack of data on aggregate exposure to single substances and to combinations of chemical substances, as well as insufficient evidencebased. Assessing exposure to phthalates the human biomonitoring. Human biomonitoring as an instrument for assessment of exposure to mercury at the meeting of representatives of the european member states health sector involvement in the implementation of the minamata convention 2425 june 2015, bonn, germany 6.
Exposure assessment is a critical component of exposure science. This task has been carried out exclusively by the authors in the context of a contract between the european food safety authority and the authors, awarded following a tender procedure. Assessment of chemical coexposure patterns based upon. The use of biomonitoring data in exposure and human health risk assessment. Oecd 2018, considerations for assessing the risks of combined exposure to multiple chemicals, series on testing and assessment no. For clarity here are the definitions of three major concepts. Internal dose based exposure and response assessment. Exa 408 interpreting biomonitoring data and using pharmacokinetic modeling in exposure assessment widespread acceptance and use of the cdcs national health and nutritional examination survey nhanes database, which, among other things, reports measured concentrations of environmental contaminants in blood and urine, has led to an expanded understanding of general population exposures in. Exposure assessment is the process of estimating or measuring the magnitude, frequency, and duration of exposure to an agent, along with the number and characteristics of the population exposed.
Hbm is the only available tool that integrates exposures from all sources and provides data to. Exposure reconstruction is illustrated by the dark blue arrows in the figure. Use of biomonitoring data to evaluate methyl eugenol exposure. This will increase trust of the consumer in safety regulation of pesticides. Although the availability of human biomonitoring data for many chemicals can greatly reduce the uncertainty associated with the use of external exposure estimates in risk assessment, experience and guidance are needed to integrate the use of biomonitoring data into the risk assessment process. Integrated assessment of exposome across life stages.
Background and framing of results communication and reportback issues. Human biomonitoring allows us to measure our exposure to chemicals by measuring either the substances themselves, their metabolites or markers of subsequent health effects in body fluids or tissues. Cdc national biomonitoring program usa is part of the national environmental public health tracking program. For assessing risk to a population, in addition to the exposure assessment data that biomonitoring may provide, additional information including sources and pathways of exposure and toxicology are needed. Biomonitoring is the assessment of human exposure to chemicals by. Data can be compared over time to evaluate whether exposures are increasing, decreasing, or staying about the same. Human exposure to environmental chemicals can occur from multiple sources, such as air, water, soil, food and consumer products. The evaluation on the usefulness of hbm for exposure assessment of. In environmental epidemiology, use of biomonitoring i. Development of biomonitoring based epidemiologic, toxicologic, and exposure assessment methods to enhance public health surveillance and the scientific communitys ability to interpret the risks posed by exposure to environmental chemicals. Biomonitoring data can be compared to be values to provide perspective as to whether the measured exposures are well below, near, or above healthbased exposure guidance values. Data analysis surveillance distribution across demographics comparison between regions comparison with nhanes exposure assessment based on exposure survey data identification of important sources of exposure e. Based on a comprehensive literature research, we present an overview of the sources of human phthalate exposure and results of exposure assessments with special focus on human biomonitoring data. Estimated phthalate exposure and risk to women of reproductive age as assessed using 202014 nhanes biomonitoring data federal register vol.
Moreover, the advantages and limitations of human biomonitoring. Mar 01, 20 biomonitoring data often reflect multiple exposure routes and pathways that may or may not correspond to the exposure routes assumed in the underlying risk assessment, and the data reflect concentrations at a point in time that may be more or less representative of long term average concentrations, depending upon the chemical and exposure pathways. Exposure assessment tools by approaches epa expobox a. The availability of biomonitoring data in humans and rodents after dietary consumptionlowdose exposure would greatly facilitate the integration of biomonitoring data into the risk assessment. Biomonitoringbased indicators of exposure to chemical. The exposure assessment section supports study design, exposure assessment, sample collection, epidemiology, and health communication for biomonitoring california. The second report, released in january 2003, presented biomonitoring exposure data for 116 environmental chemicals including the 27 in the first report for the u. Highquality biomonitoring measurements in more than 65 studies per year to determine safe and harmful human exposure. Cpsc staff statement on the tbb, tbph, tbbpa, ato the. Data from within a given study can be assessed in this context. Other factors to be considered when interpreting biomonitoring data include toxicologic factors, such as validity of the toxicologic or epidemiologic study, toxicokinetic considerations, adequacy of the sample size, reproducibility of the sample, and presence of confounding elements, and exposure factors, such as time since last exposure. Biomonitoring is one tool for exposure assessment integrates sourcesroutes of exposure trace vs environmental levels requires complex analytical methods many analytes can be measured, but not all analytes are good exposure biomarkers interpretation of biomonitoring data selection of appropriate biomarkers. Strength and limitation of hbm in risk exposure assessment.
Developing advanced tools for exposure assessment and biomonitoring. Integrating biomonitoring exposure data into the risk. Alternatively, if the biomonitoring data are to be used to understand health effects, considerably more information would be needed. The use of biomonitoring data in exposure and human. Howto guide for visualizing data from the national report on human exposure to. The utility of toxicokinetic data and models for interpreting biomonitoring data in a risk assessment context has led to the development of the concept of biomonitoring equivalents bes, which are estimates of the biomarker concentrations consistent with risk assessment based exposure guidance values 8, 14, 36. Uses of human biomonitoring data in risk assessment canada. Biomonitoring an exposure science tool for exposure and. The report recognized the value of biomonitoring for better understanding exposure to environmental chemicals, and included several findings and recommendations to improve the utility of biomonitoring data for health risk assessment. Contemporary issues in exposure assessment using biomonitoring. The application of human biomonitoring data for exposure assessment and risk characterisation has attracted major interest in recent years stamand et al. To use biomonitoring for risk assessment, some epidemiological information supporting the link between human exposures and human health outcomes needs to be available, as well as. Measurements by the national biomonitoring program are used to improve the detection, diagnosis, treatment and prevention of disease, injury, and harmful exposures in populations. The use of biomonitoring data in exposure and human health risk assessments.
Biomonitoring california program update and priorities. Population exposure assessment approaches and tools for health. The datarich chemical benzene was selected for use in a case study to assess whether refinement of the common criteria framework was necessary, and to. Human exposure assessment to environmental chemicals using. As biomonitoring data integrates all routes inhalation, dermal and oral and sources of exposure i. Review of the state of the art of human biomonitoring for.
Theres no a specific guideline that describes the use of hbm data. Statebased biomonitoring programs and nhanes exposure. While this talk concentrates on biomarkers and human biomonitoring, it is notable that it is. Apr 26, 2006 other factors to be considered when interpreting biomonitoring data include toxicologic factors, such as validity of the toxicologic or epidemiologic study, toxicokinetic considerations, adequacy of the sample size, reproducibility of the sample, and presence of confounding elements, and exposure factors, such as time since last exposure. Biomonitoring is the assessment of individual and population exposures to environmental contaminants by measuring the concentration of chemicals and or their metabolites in human specimens, such. Jul 12, 2007 exposure assessment is a critical component of exposure science.
Oct 04, 2016 fourth report 2009 cdc pdf pdf 530 pages summarizes cdcs national health and nutrition examination survey nhanes biomonitoring data from 19992004. Exposure and risk assessment to arsenic species in spanish. Assessment of chemical coexposure patterns based upon phthalate biomonitoring data within the 20072008 national health and nutrition examination survey. Integration of biomonitoring data into risk assessment sciencedirect. The present document has been produced and adopted by the bodies identified above as authors. Integration of biomonitoring data into risk assessment. Reports to the legislature senate bill sb 79 requires the program to submit a. The role of human biomonitoring in assessing and managing. Human biomonitoring data collection from occupational exposure to. Risk assessments that combine data from animal toxicology and human exposure assessment studies can also be used to interpret biomonitoring data. However, human biomonitoring as a tool for occupational exposure assessment related to.
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