SESSION VI' Integrating Biomonitoring Data into Risk Assessment

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Overview of Biomonitoring Programs Dr. Michael
P. Holsapple Executive Director, ILSI HESI
SESSION VI. Integrating Biomonitoring Data into
Risk Assessment
31st ANNUAL SUMMER TOXICOLOGY FORUM July 14, 2005
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Increased Demands for Biomonitoring Data

• U.S. Natl Health Nutrition Examination
  Survey (NHANES) - Conducted by the CDC (2001,
  2003).
• U.S. Natl Environmental Public Health Tracking
  Program - Conducted by the CDC (2004).
• U.S. Interagency Natl Childrens Study -
  (2005).
• U.S. Interagency Agricultural Health Study -
  (2005).
• U.S. Farm Exposure Study - Conducted by the
  University of Minnesota (2004).
• U.S. Natl Human Exposure Assessment Survey
  (NHEXAS) Pilot studies conducted by the EPA
  (2004).
• U.S. Programs at 12 Centers for Childrens
  Environmental Health and Disease Prevention
  Research Research coordinated by NIEHS and EPA
  to identify relevant exposures (2003).
• U.S. Biomonitoring Steering Committee Ongoing
  activities coordinated by the ACC (American
  Chemistry Council).

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Increased Demands for Biomonitoring Data

• U.S. Committee on Human Biomonitoring for
  Environmental Toxicants Review conducted by
  NAS/NRC to improve interpretation of human data
  (2004).
• Europe Scientific evidence, focused on
  Children, meant to raise Awareness, improve the
  situation by use of Legal instruments, and ensure
  a continual Evaluation of the progress made
  (SCALE) Research initiative launched by EC
  (2004).
• Europe Breast milk monitoring programs
  Research programs to provide surveillance data to
  characterize high-risk population exposures.
• Europe Biomonitoring Task Force Ongoing
  activities coordinated by ECETOC (Europ. Centre
  for Ecotoxicology and Toxicology of Chem).
• Snapshot of magnitude of global interest in
  biomonitoring.
• Cited examples are not a complete inventory of
  existing or planned biomonitoring activities in
  the public and private sectors.

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• Multiple National International Chemicals
  Programs producing toxicity, hazard exposure
  data
• US OECD HPV Chemicals.
• US VCCEP Program.
• Canadian DSL, CEPA renewal.
• EU REACH, SCALE.
• Exposure data via NHANES.
• Data from independent laboratories.

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Biomonitoring in the Scientific Literature
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With all of this information, the current default
in many cases is that Presence Hazard
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ILSI Health and Environmental Sciences (HESI)
Program
HESI BIOMONITORING TECHNICAL COMMITTEEINTEGRATION
OF BIOMONITORING EXPOSURE DATAINTO THE RISK
ASSESSMENT PROCESS
Co-Chairs Michael G. Bird, PhD,
DABT (ExxonMobil Biomedical Sciences,
Inc.) Steven H. Robison, PhD (The Procter
Gamble Company) Staff Nancy G. Doerrer, MS
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Why the HESI Program?

• Other programs will be highlighted by subsequent
  speakers during todays session.
• HESI Program is international.
• HESI Program represents input from multiple
  sectors. (tripartite approach is an operating
  principle for HESI industry government
  academics)
• Activities of HESI Program provides an excellent
  foundation for todays discussion.
• HESI Program is the one that I know the best!!!

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HESI Biomonitoring Program Mission

• To identify and refine effective scientific uses
  of biomonitoring tools and/or biomonitoring data
  to characterize exposure to chemicals.
• To explore mechanisms for integrating
  biomonitoring data and toxicology data into a
  robust risk assessment process.

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Biomonitoring Steering Team 03/04
Tripartite approach is key!!!

• Academia University of Washington.
• Government
• CDC Agency for Toxic Substances and Disease
  Registry (ATSDR).
• CDC National Center for Environmental Health
  (NCEH).
• NIH/NIEHS National Center for Toxicogenomics.
• NIH National Institute of Child Health and Human
  Development (NICHD).
• US EPA National Exposure Research Laboratory
  (NERL).
• US EPA National Health and Environmental Effects
  Research Laboratory (NHEERL).
• US EPA Office of Prevention, Pesticides, and
  Toxic Substances (OPPTS).
• Industry 3M Company, Arkema Inc, Bayer
  CropScience, Dow Chemical, DuPont Haskell
  Laboratories, ExxonMobil, Procter Gamble
  Company, Rohm and Haas, Shell.

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INTERNATIONAL BIOMONITORING WORKSHOP

• Date September 21-22, 2004.
• Location US EPA facilities in Research Triangle
  Park, NC.
• Co-sponsors
• HESI
• CDC NCEH
• CDC ATSDR
• International Council of Chemical Associations
  (ICCA)
• US EPA NERL
• Participation Over 100 invited scientists from
  US and international government agencies,
  academia, and industry.
• Purpose Explore the use of biomonitoring data
  in the context of human health risk assessment,
  with an emphasis on exposure and dose.

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INTERNATIONAL BIOMONITORING WORKSHOP
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INTERNATIONAL BIOMONITORING WORKSHOP

• Case studies prepared in advance and discussed in
  breakout sessions
• aflatoxin
• inorganic arsenic
• methyl eugenol
• organophosphates
• perfluorooctane sulfonate
• phthalates
• polybrominated diphenyl ethers

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RESEARCH NEEDS IDENTIFIED AT WORKSHOP

• Overarching Concepts
• Design biomonitoring studies to address a
  specific question or questions.
• Develop consensus criteria for applying and
  interpreting biomonitoring data.
• Use biomonitoring data to examine the risk
  assessment paradigm.

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RESEARCH NEEDS IDENTIFIED AT WORKSHOP

• Overarching Concepts (contd)
• Biomarkers integrate all routes and sources of
  exposure.
• Interdisciplinary teams are needed when
  developing research programs.
• Inter-laboratory comparison trials are needed.

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RESEARCH NEEDS IDENTIFIED AT WORKSHOP

• Specific Scientific Concepts
• Standardized analytical methods reference
  biomarker samples.
• Biomarker validation.
• Sampling strategy.
• Better communication tools.

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INTERNATIONAL BIOMONITORING WORKSHOP
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RESEARCH NEEDS IDENTIFIED AT WORKSHOP

• Specific Scientific Concepts (contd)
• Exposure arm of environmental public health
  continuum
• Understanding sources and routes of exposure.
• Information on magnitude and duration of
  exposure.
• Understanding of relationships and uses of
  exposure and effects biomarkers.

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RESEARCH NEEDS IDENTIFIED AT WORKSHOP

• Specific Scientific Concepts (contd)
• Toxicology arm of environmental public health
  continuum
• Human toxicokinetic data.
• Development of PBPK models.
• Modes of action in pre-clinical studies.

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WORKSHOP PUBLICATION(S)
Series of papers submitted for publication as a
mini-monograph in Environmental Health
Perspectives in Summer, 2005 (overview paper with
discussion of issues and identification of
research needs and data gaps plus six case
studies).
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WORKSHOP PUBLICATION(S)

• Common principles for the use of biomonitoring
  data in exposure and risk assessment. R.A.
  Albertini, M.G. Bird, N.G. Doerrer, L.L. Needham,
  S.H. Robison, L.S. Shelton and H. Zenick.
• Biomarkers of exposure A case study with
  inorganic arsenic. M.F. Hughes.
• Use of biomonitoring data to evaluate methyl
  eugenol exposure and its relationship to the
  environmental public health continuum. S.H.
  Robison and D.B. Barr.
• Potential uses of biomonitoring data A case
  study using the organophosphorus pesticides,
  chlorpyrifos and malathion. D.B. Barr and J.
  Angerer.

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WORKSHOP PUBLICATION(S)

• Common principles for the use of biomonitoring
  data in exposure and risk assessment. R.A.
  Albertini, M.G. Bird, N.G. Doerrer, L.L. Needham,
  S.H. Robison, L.S. Shelton and H. Zenick.
• Biomarkers of exposure A case study with
  inorganic arsenic. M.F. Hughes.
• Use of biomonitoring data to evaluate methyl
  eugenol exposure and its relationship to the
  environmental public health continuum. S.H.
  Robison and D.B. Barr.
• Potential uses of biomonitoring data A case
  study using the organophosphorus pesticides,
  chlorpyrifos and malathion. D.B. Barr and J.
  Angerer.

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WORKSHOP PUBLICATION(S)

• Polybrominated diphenyl ethers A case study for
  application of biomonitoring data to characterize
  exposure. L.B. Birnbaum and E.A. Cohen Hubal.
• The applicability of biomonitoring data for
  perfluorooctanesulfonate (PFOS) to the
  environmental public health continuum. J.L.
  Butenoff, G.W. Olsen and A. Pfahles-Hutchens.
• Integrating biomonitoring exposure data into the
  risk assessment process Phthalates (Diethyl
  phthalate and di(2-ethylhexyl) phthalate) as a
  case study. A. M. Calafat and R.H. McKee.

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WORKSHOP PUBLICATION(S)

• Polybrominated diphenyl ethers A case study for
  application of biomonitoring data to characterize
  exposure. L.B. Birnbaum and E.A. Cohen Hubal.
• The applicability of biomonitoring data for
  perfluorooctanesulfonate (PFOS) to the
  environmental public health continuum. J.L.
  Butenoff, G.W. Olsen and A. Pfahles-Hutchens.
• Integrating biomonitoring exposure data into the
  risk assessment process Phthalates (Diethyl
  phthalate and di(2-ethylhexyl) phthalate) as a
  case study. A. M. Calafat and R.H. McKee.

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HESI Biomonitoring Program
2005 Activities

• Build interdisciplinary, multi-sector,
  international expertise on HESI Technical
  Committee by engaging additional government,
  academic, and industry scientists.
• Establish working groups on specific scientific
  project areas.
• Maintain ongoing scientific dialogue with the
  NAS/NRC Committee on Human Biomonitoring for
  Environmental Toxicants.
• Coordinate with ICCA, ACC, ECETOC, CEFIC.

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HESI Biomonitoring Program
2005 Participation

• Academia
• Johns Hopkins University (Tim Buckley)
• Mississippi State Univ. (Jan Chambers)
• University of Erlangen, Berlin (Jurgen Angerer)
• Univ. of Vermont College of Medicine (Dick
  Albertini)
• Univ. of Washington (Elaine Faustman)

• Industry
• 3M (John Butenhoff, Geary Olsen)
• Arkema (Craig Farr)
• BASF (Andy Goetz)
• Bath and Body Works (Joel Burdick)
• Bayer CropScience (Monty Eberhart)
• Biogen (Jim Green)
• Dow (Jim Bus, Craig Barrow)
• DuPont (Mike Kaplan)
• ExxonMobil (Michael Bird, Michael Zelenka)
• Procter Gamble (Steven Robison)
• Syngenta Crop Protection (Leah Rosenheck, Martin
  Wilks)

• Government
• CDC/NCEH (Dana Barr, Antonia Calafat, Larry
  Needham)
• CDC/ATSDR (Susan Metcalf)
• EPA/NERL (Elaine Cohen Hubal, Andy Lindstrom,
  Linda Sheldon
• EPA/OPPTS (Andrea Pfahles-Hutchens)
• EPA/NHEERL (Michael Hughes, Hal Zenick)
• NIH/NCT (Jim Selkirk)

Tripartite approach KEY!!!
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HESI Biomonitoring Program
2005 Working Groups

• Generic criteria for collecting, applying and
  interpreting Biomonitoring data.
• Cumulative Risk (from a qualitative perspective
  exposure and effect).
• Biological Exposure Indices (BEIs) (occupational
  versus environmental settings).
• Epidemiology (biomarkers of exposure and effect).

Works in - progress
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HESI Biomonitoring Program

• Thanks!!
• Any questions?
• We welcome your comments.
• We welcome your participation.

mholsapple_at_ilsi.org ndoerrer_at_ilsi.org
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