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NAPHTHALENE - an update -. JOHN P. HINZ Health Risk Assessment Branch Air Force Institute for Operational Health Brooks City-Base, TX. JPH: TSERAWG (20Sep06). OUTLINE. Naphthalene “State of the Science Symposium” Mitretek Paper Outline of Industry’s Approach AFIOH’s Tox & Epi Workshop.

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naphthalene an update
NAPHTHALENE- an update -

JOHN P. HINZ

Health Risk Assessment Branch

Air Force Institute for Operational Health

Brooks City-Base, TX

JPH: TSERAWG (20Sep06)

outline
OUTLINE
  • Naphthalene “State of the Science Symposium”
  • Mitretek Paper
  • Outline of Industry’s Approach
  • AFIOH’s Tox & Epi Workshop
naphthalene state of the science symposium
NAPHTHALENE “State of the Science Symposium”
  • Scheduled for 9-12Oct06, Monterey, CA
  • Recruited distinguished roster of independent researchers

& naphthalene experts for a circumspect accounting of what is known/unknown

  • Focused around 4 basic issues/themes
    • Animal data
    • Human data
    • Anatomy, physiology, metabolic activation/deactivation
    • Mechanisms of carcinogenesis
    • Uncertainty analysis
  • Guidance on best directions for research
mitretek paper carcinogenicity of naphthalene commentary suggestions
MITRETEK PAPERCarcinogenicity of Naphthalene – Commentary & Suggestions
  • OSD tasker to clarify/highlight issues, data gaps, possible

studies to address areas of uncertainty

    • Intended for submission to NS3 & EPA
  • Issues, data gaps & uncertainties
    • Are the NTP studies unconfounded?
    • Is the rodent model pertinent & predictive of human risk?
    • Is the LMS model the appropriate tool, or is N a threshold carcinogen? Or both…?
    • What does epidemiology, and our experience, tell us?
  • Suggestions for research/studies to clarify areas of uncertainty
  • Finalize & clear with OSD & legal, etc.; submit to NS3
industry s perspective ad hoc naphthalene coalition
INDUSTRY’S PERSPECTIVE- ad hoc Naphthalene Coalition -
  • Supportive of NS3
    • Watching the symposium’s development closely
    • Will assess the symposium’s results carefully
  • Drafting outline for a research plan
    • Addresses: short term & long term research needs

data insufficiencies

regulatory uncertainty factors

    • Elements: exposure assessment, classic epidemiology, molecular epidemiology, genotoxicity, mechanism & mode of action, toxicology
    • Lessons learned from chloracetanilide pesticide MOA program
  • Under development/review for submission to NS3
afioh sponsored 1 day workshop naphthalene exposure epidemiology human effects cancer
AFIOH-SPONSORED 1-DAY WORKSHOP“Naphthalene: exposure, epidemiology, human effects & cancer”AFIOH-SPONSORED 1-DAY WORKSHOP“Naphthalene: exposure, epidemiology, human effects & cancer”
  • Point of focus – seeming lack of epidemiological evidence for naphthalene-related cancer in humans
    • Different parties each had pieces of an incomplete puzzle
    • Assembled sampling of gov & industry experts
      • Morning: share & compare what we know

highlight what we don’t know

      • Afternoon: generate issues/suggestions for research on uncertainties pertinent to improving naphthalene’s risk assessment
      • Action items identified
      • Meeting summary forthcoming
  • Support for submission to NS3
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