Alternatively, if the biomonitoring data are to be used to understand health effects, considerably more information would be needed. Biomonitoring for environmental chemicals in human biological media has become an indispensible feature of the chemical risk assessment landscape. 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. 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. 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. Oecd 2018, considerations for assessing the risks of combined exposure to multiple chemicals, series on testing and assessment no. 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. Howto guide for visualizing data from the national report on human exposure to. Exposure to phthalates is considered to be potentially harmful to human health as well. Rate exposure assessment modules exa 408, exa 409 science. 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. Human biomonitoring data collection from occupational exposure to. Human biomonitoring data collection from occupational. Ideally, it describes the sources, routes, pathways, and uncertainty in the assessment.
Contemporary issues in exposure assessment using biomonitoring. 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. Integrating biomonitoring exposure data into the risk assessment process. Uses of human biomonitoring data in risk assessment canada.
Data from within a given study can be assessed in this context. Uses of human biomonitoring data in risk assessment. Integration of omics and hts data, individual genetic susceptibility. However, human biomonitoring as a tool for occupational exposure assessment related to. This will increase trust of the consumer in safety regulation of pesticides. Chemicals in the second national report on human exposure to environmental chemicals lead.
Exposure assessment tools by approaches epa expobox a. Review of the state of the art of human biomonitoring for. 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. However, the complexities of exposure biomarker and biomarkerresponse relationships have limited the use of biomarkers in exposure science studies. The use of biomonitoring data in exposure and human health risk assessment. 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. The use of biomonitoring data in exposure and human health. As biomonitoring data integrates all routes inhalation, dermal and oral and sources of exposure i.
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. 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. 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. The present document is published complying with the transparency principle to which the authority is subject. Use of biomonitoring data in conjunction with other appropriate health and environmental. National research council published a report, human biomonitoring for environmental chemicals. Biomonitoring studies of environmental stressors are useful for confirming exposures, estimating dose levels, and evaluating human health risks. Biomonitoringbased indicators of exposure to chemical. 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.
While this talk concentrates on biomarkers and human biomonitoring, it is notable that it is. Pdf the use of biomonitoring data in exposure and human. The application of human biomonitoring data for exposure assessment and risk characterisation has attracted major interest in recent years stamand et al. See ipcs, 2004 glossary of key exposure assessment terminology pdf 122 pp, 951 k, about pdf. Harmonizing analytical chemistry and clinical epidemiology. Theres no a specific guideline that describes the use of hbm data. Parks will establish a comprehensive program of worker exposure assessment using qualified industrial hygienists and park employees who have been trained as workplace monitors. Estimated phthalate exposure and risk to women of reproductive age as assessed using 202014 nhanes biomonitoring data federal register vol. Guidance is also provided on presenting the results of the exposure assessment and characterizing uncertainty. Summary human biomonitoring for environmental chemicals. Biomonitoringbased indicators of exposure to chemical pollutants. 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.
The role of human biomonitoring in assessing and managing. Jul 12, 2007 exposure assessment is a critical component of exposure science. Biomonitoring data are now widely used in studies of health outcomes to identify or understand potential relationships between exposure and responses. The data are analyzed separately by age, sex and raceethnicity groups. 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. This would enable monitoring of the effectiveness of the legally binding international agreement on mercury, the minamata convention, as well as related parma commitments. The present document is published complying with the transparency principle to. The use of biomonitoring data in exposure and human health risk assessments. Exposure information department of toxic substances control. The evaluation on the usefulness of hbm for exposure assessment of. 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. The potential for the formation of a reactive metabolite at high exposures as noted above suggests that more than one biomarker could be measured. In this document, an updated sourcetooutcome continuum is presented to better define biomarkers as.
Cdc national biomonitoring program usa is part of the national environmental public health tracking program. 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. 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. 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. 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. In this document, an updated sourcetooutcome continuum is presented to better. Guidance for the interpretation of biomonitoring data. It also presents firsttime exposure information for 75 of the 212 chemicals included in the report. Human biomonitoring can be an effective tool for assessing exposure to a variety of chemicals. Exposure reconstruction is illustrated by the dark blue arrows in the figure. Interpreting biomonitoring data in a risk assessment context.
Assessment of chemical coexposure patterns based upon phthalate biomonitoring data within the 20072008 national health and nutrition examination survey. 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. Guidance for the interpretation of biomonitoring data b. Internal dose based exposure and response assessment. 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.
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. Data were obtained from assessments of the flame retardants prepared by united states u. Pdf the role of human biological monitoring in health risk. Human exposure to environmental chemicals can occur from multiple sources, such as air, water, soil, food and consumer products. The use of biomonitoring data in exposure and human. Biomonitoring california program update and priorities. In addition, biomonitoring data generated from outside canada may also be used. Biomonitoring is the assessment of human exposure to chemicals by. National biomonitoring program new and improved, highquality biomonitoring methods for priority environmental chemicals. 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. Comments from the natural resources defense council re. We discuss some factors relevant for interpreting and understanding biomonitoring data, including selection of both biomarkers of exposure and human matrices, and toxicokinetic information.
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 and risk assessment to arsenic species in spanish. Few chemicals are in that data rich category lead and mercury are two. The present document has been produced and adopted by the bodies identified above as authors. Exposure values are not predefined, or outlined for risk assessment. Hbm can be applied to the different steps of risk assessment, but its obvious core role lies within human exposure assessment. Learn where chemicals are found and ways to reduce exposure. Mar 08, 2017 the present document has been produced and adopted by the bodies identified above as authors. Integration of biomonitoring data into risk assessment sciencedirect.
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. Biomarker data, gathered through biomonitoring, can strengthen exposure assessment. Evaluation of biomonitoring data from the cdc national. Human exposure assessment to environmental chemicals. In environmental epidemiology, use of biomonitoring i. While personal care products, food packaging and other consumer conveniences have improved some. However, depending on the intended use, biomonitoring, like all exposure tools, may not be a standalone exposure assessment tool for some. Oct 04, 2016 fourth report 2009 cdc pdf pdf 530 pages summarizes cdcs national health and nutrition examination survey nhanes biomonitoring data from 19992004. Although exposure biomarkers should reflect a persons exposure to the target chemicals or their precursors within a specific timeframe, timing. 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. Increasing focus on subtle biological alterations, population risks. For clarity here are the definitions of three major concepts.
Strength and limitation of hbm in risk exposure assessment. 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. It is the process of estimating an external exposure to a chemical that is consistent with and based. 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. Human exposure assessment to environmental chemicals using. 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.
Use of biomonitoring data to evaluate methyl eugenol exposure. 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. 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. The biomonitoring data are available as part of the nhanes dataset, which can be obtained from cdc. Cpsc staff statement on the tbb, tbph, tbbpa, ato the.
Integration of biomonitoring data into risk assessment. Population exposure assessment approaches and tools for health. Biomonitoring programmes are useful for investigating human exposure to environmental chemicals. Assessing exposure to phthalates the human biomonitoring. Data on exposure to multiple chemicals within and between chemical classes can be assessed to. Developing advanced tools for exposure assessment and biomonitoring. Harmonizing analytical chemistry and clinical epidemiology for human biomonitoring studies. 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. Exposure assessment is a critical component of exposure science.
Measurements by the national biomonitoring program are used to improve the detection, diagnosis, treatment and prevention of disease, injury, and harmful exposures in populations. Human biomonitoring study results are published as reports text pdf together with background information about the chemical analytes. Highquality biomonitoring measurements in more than 65 studies per year to determine safe and harmful human exposure. 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. Biomonitoring equivalents can be used for evaluation of biomonitoring data in a risk assessment context. Moreover, the advantages and limitations of human biomonitoring. Nov 01, 2006 the applicability of biomonitoring data for perfluorooctanesulfonate to the environmental public health continuum. Background and framing of results communication and reportback issues. 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. Integrating biomonitoring exposure data into the risk. Biomonitoring an exposure science tool for exposure and.