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

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Presentation transcript:

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

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 OSD tasker to clarify/highlight issues, data gaps, possible studies to address areas of uncertainty –Intended for submission to NS 3 & 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 NS 3

INDUSTRY’S PERSPECTIVE - ad hoc Naphthalene Coalition - Supportive of NS 3 –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 NS 3

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 NS 3 AFIOH-SPONSORED 1-DAY WORKSHOP “Naphthalene: exposure, epidemiology, human effects & cancer”

QUESTIONS?