LHP 03-2010DRAFT ARA Workshop I1 Break-out Group B #5: Formaldehyde #12: IEUBK/Pb #26: Acrylamide Recommended all go forward (with funding considerations)

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LHP DRAFT ARA Workshop I1 Break-out Group B #5: Formaldehyde #12: IEUBK/Pb #26: Acrylamide Recommended all go forward (with funding considerations)

LHP DRAFT ARA Workshop I2 Group B Participants Nathalie Foronda (NZ) Kip Haney (TCEQ): Chair Lindsey Jones (TCEQ): Ass’t rapporteur Jerry Merski (Altria Client Services) Martha Moore (NCTR) Lynn Pottenger (Dow): Rapporteur Bob Tardiff (Sapphire) Kimberly Wise (API) Tong Zhou (FDA) [Harvey Clewell] [Thomas Dydek] [Suneeta Mahagaokar]

LHP DRAFT ARA Workshop I3 #5: Formaldehyde Problem Formulation: HPV chemical with widely dispersive exposure: inhalation exposure focused on health-based risk estimates for toxicity/cancer (rats-nasal tumors; humans-respiratory tract tumors) Methodology: Highly developed/detailed MOA (Pathophysiology process: cytotoxicity/cell proliferation-regeneration/hyperplasia/tumors), applies BBDR approach to quantify risk (integrates broad amount of data: cell proliferation rates, mutation rates, cross-links, etc.); need to incorporate genomic data & oncogene/tumor suppressor gene mutation data on p53/K-ras; Could address the following issues: –includes endogenous/background exposure and background processes; –address uncertainty and variability issues; –cross-species extrapolation (rats to humans); –test low-dose linearity proposal of SB; –incorporation of chemical-specific data; –address how much data is enough to depart from default. Team: The Hamner/EPA folk plus Bruce Allen; Biologist: Barb Parsons, NCTR( ?), LHP (?); pathologist/cancer expertise (?); regulatory: Kip Chaney (TCEQ), EPA/IRIS Chemical Mgr (?); [Exposure expert (to address human exposure?)]

LHP DRAFT ARA Workshop I4 #12: IEUBK & Pb Problem Formulation: Predict blood level in children exposed by various media (air, soil, food, etc.); (Literature review: Determine if current ‘level of concern’ (0.48 mmole/L) is appropriate); [this model can be used to evaluate soil clean-up targets] Methodology: IEUBK model (both child and adult versions exist), developed specifically for lead, is actively used by USEPA & states: translates environmental sources of lead exposure into internal dose (blood lead level); could address the following issues: –incorporates background exposure in model predictions of dose-metrics (SB issue); –assess variability in exposure using distributions (e.g., dietary, water) (SB issue); –(lit review may help address low-dose linearity issue; SB issue) Team: NZ Ministry of Health: Toxicology (N. Foronda); Public Health Physician (D. Read); Massey U. Epidemiologist (B. Borman); Modeller (TBD?)

LHP DRAFT ARA Workshop I5 #26: Acrylamide Problem Formulation: HPV chemical with widely dispersive exposure, including diet: focus on oral exposure and developing MOA-based health-based risk estimates for cancer (rats- thyroid [& other] tumors; mouse-skin & lung tumors; humans-no specific target; epi data negative) Methodology: Develop MOA approach based on WOE, based on acrylamide and its metabolite glycidamide; apply PBPK and BBDR approaches to understand the shape of the low dose dose-response curve; eventually use to quantify low dose risk; consider & incorporate new data from NCTR bioassays & MOA data (plan to use exposure characterized by JECFA); Could address the following issues: –includes endogenous/background exposure and background processes (mutation); –address uncertainty and variability issues; –cross-species extrapolation (rats and mice to humans); –test low-dose linearity proposal of SB; –incorporation of chemical-specific data (lots of new data); –application of MOA based on WOE; –address how much data is enough to depart from default. Timeframe: Target completion in timeframe (may be challenge given new data & differing views) Team: Bob Tardiff (Sapphire); M. Leigh Carson (Sapphire); Martha Moore (NCTR); Fred Beland (NCTR); Dan Doerge (NCTR); John Young (ret. NCTR); Lynne Haber (TERA); Errol Zeiger (consultant); David Gaylor (consultant); Sarah Henry (CFSAN) (?); Tong Zhou (FDA); TCEQ or other state rep?