Public Health Applications Of Human Biomonitoring
U.S. Environmental Protection Agency’s (EPA)National Center for Environmental Research (NCER)andInternational Council of Chemical Associations’ (ICCA)Long-Range Research Initiative (LRI)Public Health Applications ofHuman BiomonitoringWorkshop Summary ReportMarch 18, 2008FINALSourceEnvironmentExposureDoseResponseThe Risk Assessment Paradigm. This framework summarizes the factors necessary tocharacterize a chemical’s risk. Sources, environment, exposure, dose, and associated response(i.e. biological effects) must be evaluated, as well as the relationships among them.Biomonitoring helps in understanding each of these elements. The goal of the workshop was toaddress challenges in the application of biomonitoring to public health scenarios.
U.S. Environmental Protection Agency’s (EPA)National Center for Environmental Research (NCER)andInternational Council of Chemical Associations’ (ICCA) Long-RangeResearch Initiative (LRI)Public Health Applications of HumanBiomonitoringWorkshop Summary ReportSeptember 24 & 25, 2007U.S. EPAResearch Triangle Park, North CarolinaFINALPrepared forAmerican Chemistry Council1300 Wilson BoulevardArlington, VA 22209Prepared byICF International9300 Lee HighwayFairfax, VA 22031March 18, 2008
CONTENTSOrganizing Committee Members . iiList of Acronyms .iv1.0Introduction .12.0Session Highlights .42.1Setting the Stage for the Meeting .42.2Applications of Biomonitoring in Public Health .52.3International Perspectives.72.4Looking Ahead: Perspectives on the Public Health Applications of Biomonitoring Data .73.0Parallel Symposium Reports.93.1Parallel Symposium 1: Scientific Advances in Interpretation of Biomonitoring Data .93.2Parallel Symposium 2: Challenges Faced in Communication of BiomonitoringInformation .113.3Parallel Symposium 3: Application of Biomonitoring Data to Usefully Characterizeand Prioritize Vulnerable Populations for Public Health Tracking .164.0References .19APPENDIX A: ICCA BIOMONITORING WORKSHOP FINAL AGENDA. A-1APPENDIX B: ICCA BIOMONITORING WORKSHOP LIST OF POSTER PRESENTATIONS.B-1FINAL – March 2008Page i
Organizing Committee MembersKacee Deener, Co-ChairU.S. Environmental Protection Agency (EPA)Office of Research and DevelopmentNational Center for Environmental ResearchTina Bahadori, Co-ChairAmerican Chemistry Council (ACC)Long-Range Research InitiativeStan BaroneU.S. EPAOffice of Research and DevelopmentNational Center for Environmental AssessmentDana BarrCenters for Disease Control and PreventionNational Center for Environmental HealthPublicationsDivision of Labor SciencesRick BeckerACCPublic Health and Science PolicyJerry BlancatoU.S. EPAOffice of Research and DevelopmentNational Center for Computational ToxicologyPeter BoogaardShell Health - Shell International BVSarah BrozenaACCPublic Health and Science PolicyJim BusThe Dow Chemical CompanyHealth & Environmental Research LabBruce CaswellCanadian Chemical Producers’ AssociationEnvironment, Health and SafetyAkira FukushimaLion Corporation, JapanJapan Chemical Industry Association (JCIA)FINAL – March 2008Peggy GeimerArch Chemicals, Inc.Medical DepartmentAndrew GellerU.S. EPAOffice of Research and DevelopmentNational Health and Environmental EffectsResearch LaboratoryAnnette Guiseppi-ElieDuPont EngineeringCorporate Remediation GroupDoug HainesHealth CanadaDivision Safe Environments ProgrammeElaine HubalU.S. EPAOffice of Research and DevelopmentNational Health and Environmental EffectsResearch LaboratoryJunpei ItohMitsui Chemicals, Inc., JapanMasatoshi KumamotoJCIAChemicals Management DepartmentDonald MolenaarBayer Corporate & Business ServicesCorporate Medical ServicesChris MoneyExxon Mobil Petroleum & ChemicalMarsha MorganU.S. EPAOffice of Research and DevelopmentNational Exposure Research LaboratoryJan MostowyBayer CorporationProduct Safety & Regulatory AffairsPage ii
Larry NeedhamCenters for Disease Control and PreventionNational Center for Environmental HealthYasuyoshi OkunoSumitomo Chemical Co., Ltd.Corporate Planning & Coordination OfficeEnvironmental Health Science LaboratoryDan PetersenU.S. EPAOffice of Research and DevelopmentNational Risk Management Research LaboratoryDick PhillipsExxonMobil Petroleum & ChemicalKathy PlotzkeDow CorningHealth and Environmental SciencesSteven RobisonProcter & GambleDepartment of Central Product SafetyGreet SchoetersVITO (Flemish Institute for TechnologicalResearch)Environmental Toxicology UnitLinda SheldonU.S. EPAOffice of Research and DevelopmentNational Exposure Research LaboratoryFumiaki ShonoJCIAChemicals Management DepartmentHugh TilsonU.S. EPAOffice of Research and DevelopmentNational Exposure Research LaboratoryMarc WilluhnCefic (European Chemical Industry Council)Long-Range Research InitiativeFINAL – March 2008Page iii
List of STARAmerican Chemistry CouncilBiological equivalentsBoston University School of Public HealthCenters for Disease Control and PreventionEuropean Chemical Industry CouncilCenter for the Health Assessment of Mothers and Children of SalinasEuropean Centre for Ecotoxicology and Toxicology of ChemicalsEnvironmental Protection AgencyExpert Team to Support Biomonitoring Research in EuropeFatty acid ethyl estersInternational Council of Chemical AssociationsInstitute of MedicineInstitutional Review BoardNational Institute of Environmental Health SciencesNon-governmental organizationJapan Chemical Industry AssociationLong-Range Research InitiativeMechanistic Indicators of Childhood AsthmaNational Children’s StudyNational Health and Nutrition Examination SurveyPhysiologically-based pharmacokineticPersistent organic pollutantReference DoseScience to Achieve ResultsFINAL – March 2008Page iv
1.0INTRODUCTIONOn September 24 and 25, 2007, the U.S. Environmental Protection Agency’s (EPA)National Center for Environmental Research (NCER) hosted a workshop on the public healthapplications of human biomonitoring in Research Triangle Park, North Carolina. The workshopcentered on challenges in the application of biomonitoring research to public health. It focuseddiscussion on the interpretation and communication of biomonitoring data and on the use ofbiomonitoring data to identify and prioritize vulnerable populations for public health tracking.Issues regarding the ethics of human biomonitoring practice and the responsible communicationof biomonitoring information to the general public (including targeted subpopulations) werehighlighted and discussed in the context of recent scientific advances in the biomonitoring field.The workshop was co-sponsored by the U.S. EPA’s NCER and the International Council ofChemical Associations (ICCA)’s Long-Range Research Initiative (LRI), which is composed ofthe LRI’s of the American Chemistry Council (ACC), Cefic (European Chemical IndustryCouncil), and Japan Chemical Industry Association (JCIA). It was attended by 191representatives from industry, academia, media, non-governmental organizations (NGOs), andvarious government agencies (see Exhibit 1).Starting in 2002, LRI programs in both the U.S. and Europe have funded research toidentify ways to understand predominant sources and pathways of exposure, characterize therelationship between exposure to environmental contaminants and biomonitoring data, andidentify holistic ways to elucidate the relationship among biomonitoring data, dose, and healthoutcomes. The ICCA-LRI identified the interpretation of biomonitoring data as its highestpriority research area in 2005. The U.S. EPA has also identified biomarker research as a priority,recognizing the usefulness of biomonitoring for assessing exposure, understanding vulnerability,and evaluating public health outcomes. Through its Science to Achieve Results (STAR) grantsprogram, EPA has funded a large body of work focused on the development and validation ofbiomarkers, the use of biomarkers for assessing exposure and risk, and most recently, the soundinterpretation of biomarkers. The most recent awards, which were announced this September,total nearly 4 million and are intended to help develop advanced modeling techniques that willimprove understanding of existing biomonitoring data.In 2006, the ICCA-LRI convened a biomonitoring workshop that helped to coordinateand spur its research activities in this field (Bahadori et al. 2007). For this year’s biomonitoringworkshop, ICCA collaborated with U.S. EPA to bring together colleagues across a wide range ofsectors. The workshop was designed to investigate the relationships among several key topics inbiomonitoring research and application: recent advances in the scientific community;communication of biomonitoring data to the medical community, individual study participants,the broader public, and the media; and setting priorities for public health, such as the applicationof biomonitoring data for the protection of vulnerable populations and the appropriatecommunication of health and safety information. For both the ICCA-LRI and U.S. EPA’sNCER, the international workshop provided a basis for continued collaboration among interestedstakeholders, for maintenance and expansion of partnerships in biomonitoring research andapplication, for the improvement of networking across stakeholders to further maximizeresources and for continued research into the public health applications of human biomonitoring.FINAL – March 2008Page 1
Exhibit 1Affiliations of Participants Who Attended theU.S. EPA – ICCA 2007 Biomonitoring Workshop3MAmerican Chemical SocietyAmerican Chemistry CouncilArch Chemicals, Inc.Bayer AGBayer CropScienceBayer MaterialScienceBASFBattelleBNA, Inc.Boston UniversityCalifornia Environmental Protection AgencyCanadian Chemical Producers’ AssociationCase Western Reserve UniversityCefic (European chemical industry council)Centers for Disease Control and PreventionCiba Specialty ChemicalsClark UniversityColorado State UniversityCropLife AmericaCytec Industries, Inc.Dow Chemical CompanyDow Corning CorporationDuPontEastman Chemical CompanyEnvironmental DefenseEnvironmental and Occupational Health SciencesInstituteExponent, Inc.ExxonMobilHamner Institutes for Health SciencesHealth CanadaHealth Protection Agency, UKICF InternationalInside Washington PublishersInternational Life Sciences InstituteInternational Union of Pure & Applied ChemistryJapan Chemical Industry AssociationLanxess Corp.LifeLine GroupLion CorporationLockheed MartinLR Risk ConsultingMcMaster UniversityMinnesota Department of HealthMitsui Chemicals, Inc.National GeographicNational Institutes of HealthNational Laboratory Training NetworkNorth Carolina Central UniversityNorth Carolina State UniversityOhio State UniversityRTI InternationalShellSoap and Detergent AssociationState University of New York at BuffaloSummit ToxicologySyngenta Crop Protection, Inc.United Nations Environment ProgrammeVITO (Flemish Institute for Technological Research)University of California at BerkeleyUniversity of California at DavisUniversity of CopenhagenUniversity of LeicesterUniversity of North Carolina at Chapel HillUniversity of PittsburgU.S. Environmental Protection AgencyU.S. Government Accountability OfficeVerband der Chemischen Industrie e.V. (VCI)Weinberg Group, Inc.The agenda for the two-day workshop, which includes the speakers, is provided inAppendix A. The first day of the workshop featured presentations by invited speakers, who setthe stage for the focused discussions that followed later in the day during the parallel symposia.These symposia incorporated speakers on specialized topics and panel discussions. There werethree parallel symposia, and each focused on one of the following topics: (1) scientific advancesin interpretation of biomonitoring data, (2) challenges faced in communication of biomonitoringinformation, and (3) the application of biomonitoring data to usefully characterize and prioritizevulnerable populations for public health tracking. A poster session was held in the evening of thefirst day, showcasing biomonitoring research from 30 projects in both the U.S. and Europe; a listof the posters presented is included in Appendix B. The parallel symposia concluded on thesecond day, with rapporteurs from each session presenting a summary of their deliberations andconclusions to the reconvened main workshop body. International perspectives were shared byinvited speakers from Europe, Canada, and Japan. Finally, the workshop closed withpresentations looking ahead at future directions of the field.FINAL – March 2008Page 2
These proceedings are a summary of the presentations, discussions, and overarchingthemes from both the plenary and parallel symposia. This report is intended to summarize themain themes of the discussions and is part of a process that is intended to enhancecommunication among all parties and to document the current state of the field of biomonitoring.FINAL – March 2008Page 3
2.0SESSION HIGHLIGHTSAlthough several definitions of biomonitoring were presented by speakers during bothdays of the workshop, all definitions were quite similar in terms of the basic concept and thebreadth to which they can be applied. See Exhibit 2 for a description and potential applicationsof biomonitoring. A summary of the plenary sessions and highlights of the presentations arepresented in the sections that follow.2.1Setting the Stage for the MeetingThe overarching themeof the speaker presentations inthis session was theinterpretation and practicalapplication of biomonitoringinformation to identify andcharacterize health risks fromchemical exposures. The valueof biomonitoring data will begreatly increased if they can beused to evaluate responses tothe chemical exposures as wellas the presence of an exposure.Exhibit 2What is Biomonitoring?Human biomonitoring is the measurement of chemicals—ortheir biological breakdown products, known as metabolites orbiological markers —in biological media such as blood andurine. A breathalyzer test is an example of biomonitoring.While biomonitoring can reveal whether exposure andabsorption have occurred and whether levels are increasingor decreasing over time, it may not necessarily indicatewhether there is any risk to health. Also, biomonitoring datado not always reveal when or how often an exposure hasoccurred, the concentration of the exposure, or the pathwaysof exposure (i.e., biomonitoring data integrate allsources/routes of exposure). Correctly measuring exposuredepends on the chemical and the frequency of samplecollection and analyses. And certain chemicals leavefingerprints, depending on the sources (e.g., dioxin-likecompounds, volatile organic compounds).Speakers from thissession represented two verydifferent scales of involvementin the biomonitoring researchPotential Applications of Biomonitoringfield: academic research, withan emphasis on uncovering the Estimation of exposuresunderlying mechanisms for Identification of fate of substances in the bodybiological response to Determination of exposure trendschemicals, and large-scale Provision of early warning signals about exposuresgovernment research, focusing Establishment of linkages between environmentalon coordinating studies acrossexposures and (adverse) health effects Development of reference ranges (e.g., for publiclarge population segments.health tracking)Significant points of Guidance for the design of animal toxicology studiescommonality between theand exposure and health effects research byspeakers included the focus onproviding information on more environmentallyparticularly vulnerablerelevant dosessubpopulations and onuncovering adverse effects tolow chemical exposures. In this session, and throughout the entire workshop, the development ofpartnerships between stakeholders emerged as a key element to building successfulbiomonitoring programs.FINAL – March 2008Page 4
Biomonitoring research performed across international borders, or even from oneinstitution to another, can reflect different priorities and can lead to different policies andinterventions. Such differential approaches can make it difficult to pool resources or compareresults. Therefore, international collaboration represents a worthwhile effort that can fosteruniversal (rather than national) strategies, as does the Expert Team to Support BiomonitoringResearch in Europe (ESBIO), which is a collaboration of European Union member states, withinput from industry and NGOs. ESBIO is intended to meet objectives that reflect the goals of theinternational biomonitoring community, including the following priorities: Integration of environmental and health monitoring data; Implementation of a coordinated framework for human biomonitoring; Development of approaches for interpretation of human biomonitoring data for publichealth applications; Communication, management, and reduction of risks identified with environmental andhuman biomonitoring data; and Creation of scenarios for input into policymaking (ESBIO 2007).Coordinated or international approaches, such as that used in ESBIO, are an attempt to bridge thedifferences among current national approaches, thus resulting in more global, comparable data,providing wider access to biomonitoring data (Reis et al. 2007), and enabling the pooling ofresources.Research results that can be readily applied to policy development are of paramountconcern to the public. Scientists in research programs must be able to translate the data intopractical applications to be usable by policymakers. A key step to reducing risks posed bychemical exposures is to fill in the knowledge gaps in the risk assessment process (Albertini etal. 2006). Frequently, the least understood element in the risk assessment paradigm is themechanism by which a chemical exposure produces an adverse health effect. Therefore,improving our understanding of these mechanisms can help identify, prioritize, and ultimatelyreduce risks from chemical exposures. For example, researchers have used biomarkers to shedlight on the mechanism through which benzene exposure results in toxic metabolites (Kim et al.2006, 2007; Lin et al. 2007). Characterizing differences in subpopulations is also important, assome groups may be more vulnerable than others to chemical exposures. Ethical concerns(e.g., intervention, reporting of exposure and health risks to participants) must be consideredwhen conducting biomarker research, even in places where intervention is politically unwelcomeor socially stigmatized.2.2Applicatio
Dan Petersen U.S. EPA Office of Research and Development National Risk Management Research Laboratory Dick Phillips ExxonMobil Petroleum & Chemical Kathy Plotzke . total nearly 4 million and are intended to help develop advanced modeling techniques that will improve understanding of existi
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