1. environmental • failure analysis & prevention • health • technology development
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2. Center for Toxicology & Mechanistic Biology
Emerging Issues in Industrial Hygiene – The Impact of Biomonitoring Data
Sol Bobst, PhD
Senior Scientist
Center for Toxicology & Mechanistic Biology
EXPONENT, Inc.
Houston, Texas
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3. Biomonitoring Overview
What is it?
Intended Uses
Interpretation
TLV / BEI Evaluation Process
Resources
Acknowledgements

4. What is Biomonitoring?
“Biomonitoring,” is defined in the environmental public health field as the assessment of human exposure to an environmental chemical via the measurement of that chemical, its metabolites, or reaction product(s) in human blood, milk, urine, saliva, adipose, or other tissue in individuals (in a population).
Needham: Int J Hyg Env Health, 2006

5. Why is it important to the Practice of Industrial Hygiene?
Identification
Evaluation
Control

6. Current Consensus
Biomonitoring Data are being generated and published faster than regulators and professionals can analyze and interpret them.
There is a need for well defined guidelines for interpreting biomonitoring data.
There is a need to understand how biomonitoring data should be utilized in a risk evaluation framework for regulators and industrial stakeholders.
There is a need to clearly communicate that biomonitoring data do not substantiate a human health risk and disease.

7. Intended Uses for Biomonitoring
Provide a metric of exposure for use in risk assessment.
Monitor/Idenitfy exposure trends within a population.
Use available tools to provide the basis for more effective design of approved studies / risk assessments.

8. Use in Risk Assessment Establish & Characterize Exposure / Trends.
Investigate “linkages” between exposure and adverse health effects.
Facilitate Risk Management.
ECOTOC Document 44, November 2005

9. The Challenge
The Production of Biomonitoring Data, or utility of a Biomonitoring Study, often does not address all of the requirements for rigorous and effective risk evaluation.
What does the data mean? How is it useful? What is inappropriate interpretation?

10. Issues in Biomonitoring
Data Quality
Interpretation
Ethics
Transperency
Biomonitoring vs. Biomarkers

11. Data Quality
Requirements – Must address intended use, but also evaluate potential use
Methodology, Study Design, Calibrations
Technical Quality

12. Interpretation of Biomonitoring
Analytical Integrity
Standardized Methodology,
(local vs. international standards)
Recovery, Reproducibility
Accounting for false positives/contamination

13. Ability to Describe Exposure Requires Toxicokinetics
Routes of Exposure
Endogenous Contribution
Pharmacokinetics/Pharmacodynamics of Absorption, Distribution, Metabolism, Excretion
Genotoxic Effects
Forward or Reverse Extrapolation of Dose

14. Exposure – Effect Continuum

15. Benefits of Including Biomonitoring Evaluation into Industrial HSE Policy
Enhance Risk Management.
Case by Case evaluation of chemical specific Biomonitoring can result in effective guidance for data development of:
Animal testing
Methodologies for assessing human exposure
IH sampling.
Save Time, Resources, Money.

16. Shift in Focus
From External Exposure Concentrations to Internal Dose Estimation.
Future Regulatory Decisions may set exposure guidelines (EPA, OSHA, TCEQ) based on BEI(s), or Biomonitoring / Biomarker indices.

17. Biomonitoring Interpretation in Industrial Hygiene
ACGIH
Process for Evaluating TLV/BEI
Opportunity for Involvement

18. Interpretation Define Limitations
Example – One Person – One Blood Sample – One Test!!!!!
NHANES Study, CDC
Account for Variability – Population Context
Age, Gender, Sample Volume, Geographical Location of Sample

19. Biomarker Evaluation is an Important Step in Interpreting Biomonitoring Data
Biomarker vs. Biomonitoring Data
Biomonitoring: Arsenic in Hair (Chemical in Fluid/Tissue/Matrix)
Biomarker: DNA Adduct (Metric of Metabolism / Biological Mechanism)
Measure of Chemical Metabolite in Biological Fluid/Tissue.
Accurate Metric for Understanding External Exposure.

20. Biomarker Evaluation is an Important Step in Interpreting Biomonitoring Data

21. Feedback
What Concerns or Issues in Biomonitoring are important to you?

22. Public Resources for Biomonitoring
ECOTOC Report
NAS Report
Other

23. ECETOC Report (European Centre for Ecotoxicology & Toxicology of Chemicals)
Guidance for the Interpretation of Biomonitoring Data, Document No. 44, Brussels, November 2005.
Establishes Framework for evaluating biomonitoring data for risk assessment.
More Detailed Guidelines on Interpretation
Examples: Parabens, Hexachlorobutadiene

24. NAS Report
Human Biomonitoring for Environmental Chemicals (NRC – NAS 2006).
Conclusions:
There is a need for a consistent rationale for selecting chemicals for study based on exposure and public-health concerns.
Appropriate Statistical Principles Need to be Applied when sampling populations.
Recommend that biomonitoring program sponsors require planning for communication and evaluation. for any applied use.

25. Other
Biomonitoring.info – Environmental Health Research Foundation
CDC – National Biomonitoring Program:

26. Acknowledgements Exponent Biomonitoring Team Angelina Duggan
Elizabeth Anderson
Ben Thomas
Louis Bloemen
Sanjeev Saraf
Martin Barrie

27. References
Guidance for the Interpretation of Biomonitoring Data, Document No. 44, Brussels, November 2005, ECOTOC.
Needham, Calafat, Barr “Uses and issues in biomonitoring” Int J Hyg Environ Health 2007 May;210(3-4): Epub 2006 Dec 8.
Albertini , Bird , Doerrer, Needham, Robison, Sheldon, Zenick. “The use of biomonitoring data in exposure and human health risk assessments.” Environ Health Perspect Nov;114(11):
Doerrer “Integration of human biomonitoring exposure data into risk assessment: HSEI intiatives and perspectives Int J Hyg Environ Health ;

28. Report Website Links
NAS Biomonitoring Report -
ECETOC Report -