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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. 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 -

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  1. NAPHTHALENE- an update - JOHN P. HINZ Health Risk Assessment Branch Air Force Institute for Operational Health Brooks City-Base, TX JPH: TSERAWG (20Sep06)

  2. OUTLINE • Naphthalene “State of the Science Symposium” • Mitretek Paper • Outline of Industry’s Approach • AFIOH’s Tox & Epi Workshop

  3. 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

  4. 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

  5. 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

  6. 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

  7. QUESTIONS?

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