GUIDANCE FOR LABORATORY BIOMONITORING PROGRAMS Developing Biomonitoring Capabilities UPDATED OCTOBER 2019 ® Association of Public Health Laboratories The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the US and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats. Acknowledgments This is an update of APHL’s 2012 biomonitoring guidance (https://www.aphl.org/aboutAPHL/publications/Documents/ EH_2012_Guidance-for-Laboratory-Biomonitoring-Programs.pdf). The development of this guidance has been a joint undertaking of the APHL National Biomonitoring Network Steering Committee APHL Biomonitoring Workgroups, APHL environmental health staff and the CDC Division of Laboratory Sciences, National Center for Environmental Health. APHL appreciates the time that many individuals who shared their knowledge, counsel and experience, and provided constructive input to the update of this document. This document was prepared by Paula Jones and Alan Gambrell, Public Ink. Funding This publication was supported by Cooperative Agreement Number #NU600E000103 with the US Centers for Disease Control and Prevention (CDC). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC. Table of Contents TABLE OF CONTENTS 1. Introduction ...................................................................................................................... 5 Purpose of this Guidance ..................................................................................................................... 5 Audience ................................................................................................................................................ 6 Goals ...................................................................................................................................................... 6 In This Guidance ................................................................................................................................... 6 2. Biomonitoring & Public Health .................................................................................. 7 About Biomonitoring ............................................................................................................................ 7 Components of Biomonitoring Studies ............................................................................................... 9 Figure: Human biomonitoring for environmental chemicals ................................................................................................... 9 Role of Biomonitoring in Public Health............................................................................................. 10 Development of the National Biomonitoring Network .................................................................... 11 3. Study Team & Advisory Panels ...............................................................................13 Core Study Team Members ................................................................................................................ 14 Additional Expertise ........................................................................................................................... 16 Advisory Panels ................................................................................................................................... 18 4. Community Engagement & Communications ....................................................19 Roles of the Community .................................................................................................................... 20 Understanding Community Engagement ......................................................................................... 21 Communicating with Policymakers about Biomonitoring ............................................................... 21 5. Laboratory Infrastructure ..........................................................................................24 Facilities .............................................................................................................................................. 25 Equipment ........................................................................................................................................... 26 Table: Analytical platforms for biomonitoring analytes ..........................................................................................................27 Information Technology ...................................................................................................................... 27 Laboratory Personnel ......................................................................................................................... 27 Table: Personnel-related experience, skills and professional development or training required to participate in biomonitoring studies (high complexity testing) ..................................................................................28 Quality Management System ............................................................................................................. 29 6. Biomonitoring Study Design ....................................................................................32 Study Design Steps ............................................................................................................................. 33 Developing Study Goals and Objectives ............................................................................................ 33 Protection of Human Subjects: Key Considerations ........................................................................ 35 Population Selection and Study Sample ........................................................................................... 36 2019 APHL Guidance for Laboratory Biomonitoring Programs | 3 Table of Contents 7. Biomarker Selection ...................................................................................................39 Types of Biomarkers ........................................................................................................................... 39 Selection of Biomarkers ..................................................................................................................... 40 Feasibility Considerations in Biomarker Selection .......................................................................... 41 8. Study Protocols & Plans ...........................................................................................43 Study Protocols ................................................................................................................................... 43 Plans .................................................................................................................................................... 45 Table: Sample logic model summarizing research efforts and evaluation plan ..................................................................46 Table: Sample logic model summarizing PHA efforts and evaluation plan ......................................................................... 47 9. Analytical Protocol & Methodology ........................................................................49 Initial Considerations in Analytical Method Selection .................................................................... 50 Table: Questions to consider in analytical method selection ................................................................................................50 Specimen Collection ......................................................................................................................... 51 Analytical Testing .............................................................................................................................. 54 Figure: Validation process flow chart ......................................................................................................................................54 Analytical Protocol ............................................................................................................................ 55 10. Preparing & Communicating Results ................................................................60 Generating Laboratory Results .......................................................................................................... 61 Table: Recommended units to present chemical analyte levels...........................................................................................62 Interpreting Results ............................................................................................................................ 63 Reporting Results ............................................................................................................................... 64 11. Appendices ..................................................................................................................68 Appendix 1: Glossary .......................................................................................................................... 69 Appendix 2: Statistical Analysis ........................................................................................................ 73 Table: Guide for statistical analysis method .........................................................................................................................