to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic INTRODUCTION Tuesday, January 8 & Wednesday, January 9 RTP, North Carolina Hosted by EPA's National Center for Environmental Assessment ------- DO NOT CITE OR QUOTE oEPA United States Environmental Protection Public Stakeholder Workshop - Development of Toxicological Review of Inorganic Arsenic USEPA / ORD / NCEA Presented by: Reeder Sams II Office of Research and Development National Center for Environmental Assessment oERA United States Environmental Protection Agency Welcome Public Stakeholder Workshop Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 1 ------- DO NOT CITE OR QUOTE Q EDA NCEA Contacts United States Environmental Protection Agency Chemical Managers for iAs Assessment John Cowden: Cowden.John@epa.gov Phone: (919)541-3667 Janice Lee: Lee.JaniceS@epa.gov Phone: (919)541-9458 Director for NCEA-IRIS - Acting Vincent Cogliano: Cogliano.Vincent@epa.gov Phone: (703)-347-0220 Deputy Director for NCEA-RTP - Acting ReederSams: Sams.Reeder@epa.gov Phone:(919)541-0661 Why is EPA holding Environmental Protection ~ this workshop? Human health Most recent IRIS assessment completed in 1988 Support and use in EPA's program / regional risk assessments and state / local government risk assessments Past human health assessment efforts for inorganic arsenic Stakeholder comments and requests Congressional Request (HR2055; HR 112-151) ¦ Review by National Academy of Sciences (NAS) Recommendations from the NAS Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 2 ------- DO NOT CITE OR QUOTE Selected NAS Recommendations From "Science and Decisions" (NAS 2009) Expand agency and interagency collaboration Implement scoping and problem formulation Consider feasibility/benefits of options in the design stages Uncertainty and variability into dose response analysis Incorporation of probabilistic and distributional methods into dose-response analysis Evaluate chemicals in terms of mode of action, background exposure, disease processes, and vulnerable populations Criteria to justify alternative assumptions in place of default assumptions Environmental Protection Selected NAS Recommendations Agency From Formaldehyde review (NAS 2011) Literature search strategy and literature evaluation criteria (e.g., systematic review) Weight of evidence evaluation for non-cancer endpoints Use HERO database to capture study information and data Sensitivity analyses for reference values and effect of uncertainty factors Harmonize characterization of uncertainty and variability Unify outcome consideration around common modes of action Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 3 ------- DO NOT CITE OR QUOTE Common Themes Environmental Protection (NAS 2011. 2009: EPA. 2005. 2000) Transparency- Explicitness in the health assessment process Clarity- Health assessment is free from obscure language and is easy to understand Consistency- Conclusions of the health assessment are characterized in harmony w/ other EPA actions Reasonableness- Health assessment is based on sound judgment SEPA Workshop Goals United States Environmental Protection Agency Ensure that EPA provides the public an opportunity to inform the Toxicological Review. - Gather scientific information and public dialogue - Many opportunities beyond this workshop > Submit information to the docket > Future public meetings > Webinar series Transparently communicate how EPA will produce an assessment that meets the needs of the Agency and the public. - Presentations during this workshop - NCEA website ¦ Other tools (e.g., IRIS List-serve, blogs, etc.) Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 4 ------- DO NOT CITE OR QUOTE SEPA Workshop Logistics United States Environmental Protection Workshop is organized into 5 sessions 1) Applying Systematic Review to the iAs Toxicological Review 2) Hazard Identification for iAs 3) Dose Response 4) Roundtable Discussion on Planning and Scoping 5) Opportunity for Additional Public Comment and Workshop Summary General format for each session - Panel Discussion (State of the Science) - Opportunity for Public Comment (Webinar & In Person) Webinar Participants - Please submit comments or questions at any time during the workshop. Comments or questions from webinar participants will be during the Discussion section for each session as indicated on the agenda. - If you experience technical difficulties, please type this in as a comment on the webinar or email: EPA_arsenic@icfi.com RTP Facility (in-person participants) - Comments and question from in-person participants will alternate with comments from the webinar SEPA Workshop Logistics United States Environmental Protectior Agency Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 5 ------- DO NOT CITE OR QUOTE oEPA United States Environmental Protection Agency Thank You... 12 oEPA United States Environmental Protection Agency EXTRA SLIDES 13 Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 6 ------- DO NOT CITE OR QUOTE ^EPA past Efforts for the Toxicological Environmental Protection Review of Inorganic Arsenic 0 First arsenic assessment posted to IRIS database in 1988 0 National Research Council (NRC)/National Academy of Sciences (NAS) review of scientific information: 1999 0 Science Advisory Board completes review of EPA Arsenic Rule: 2001 0 EPA establishes Primary Drinking Water Standard for Arsenic: 2001 0 NRC assessment and review of EPA Drinking Water Standard: 2001 0 EPA implements NRC 2001 recommendations in draft arsenic IRIS assessment and submits for Science Advisory Board review: 2005 0 Science Advisory Board completes review of EPA 2005 draft: 2007 0 Science Advisory Board completes review of EPA 2010 draft: 2011 14 oEPA United States Environmental Protection Agency Common Themes (NAS 2011. 2009: EPA. 2005. 2000) Transparency Explicitness in the risk assessment process Clarity Assessment is free from obscure language and is easy to understand -Describe assessment approaches, assumptions, extrapolations and model use -Describe plausible alternative assumptions -Identify data gaps -Distinguish science from policy -Describe uncertainty -Describe relative strength of assessment -Employ brevity -Use plain English -Avoid technical terms -Use simple tables, graphics, equations Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 7 ------- DO NOT CITE OR QUOTE SEPA United States Environmental Protection Agency Common Themes Continued (NAS 2011. 2009; EPA. 2005. 2000) Consistency Reasonableness Conclusion of the risk assessment are characterized in harmony w/ other EPA actions Risk assessment is based on sound judgment -Follow statutes -Follow Agency Guidance -Use Agency information systems -Define level of effort -Use review by peers -Use review by peers -Use best available scientific information -Use good judgment -Use plausible alternatives United States iAs Human Health Assessment Environmental Protection Agency -Considerations NAS recommendations for human health assessments (2011; 2009) Common themes with guidance documents (EPA, 2005; EPA, 2000) Social, behavioral, and physical impacts (epigenome) Useful reviews and documents: SAB (2011, 2007, 2001) NAS (2001, 1999) 17 Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 8 ------- DO NOT CITE OR QUOTE SEPA United States Environmental Protection Aaencv Decision-Making Framework (NAS 2009) FIGURE S-l A framework tor risk-based decision-making that maximizes the utility of risk assessment, SEPA United States Environmental Protection Agency Environmental Exposures Intrinsic Susceptibility Human Health/ Disease Behavior/Age/Lifestage Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 9 ------- DO NOT CITE OR QUOTE oEPA EP4 Useful Reviews and Documents: SAB (2011; 2007) were reviews of existing EPA iAs cancer assessments NAS (2001) was a human health assessment; NAS (1999) was a review of the state of the science Recommendations should be utilized as appropriate throughout the development of a new integrated assessment (e.g., criteria categories for evaluating epi literature) Some recommendations may not be as informative for developing a new assessment compared to revising an existing assessment State of the science and human health assessment approaches are evolving Office of Research and Development Mfltinnfll rpntor fnr Fnvirnnmpntal flccoccmont &EPA Workshop Goals United States Environmental Protection Agency Communication (throughout the development of the assessment) ¦ Efficient and effective means iAs human health assessment project page (internal and external) Arsenic Communication Committee ¦ List-serve ¦ Ongoing dialogue ¦ Assessment schedule Clear understanding of current regulatory practices and challenges across the Agency Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 10 ------- DO NOT CITE OR QUOTE Workshop Goals United States Environmental Protection Agency Based upon the current regulatory practices and challenges, what are the needs of the Agency with respect to a new iAs human health assessment? Problem formulation / Scoping Provide input as to how the Agency can effectively engage outside stakeholders specifically for iAs Address how Agency partners can collaborate to develop an integrated assessment for iAs SEPA United States Environmental Protection Agency EXTRA SLIDES 23 Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 11 ------- DO NOT CITE OR QUOTE Selected SAB Recommendations SAB Review of 2010 iAs Cancer Assessment (SAB 2011) Recommended EPA should more clearly state and utilize criteria to evaluate epidemiological data Improve the documentation of data sets utilized for sensitivity analyses; For complete EPA risk assessments provide context to the cancer risk estimate should be interpreted w/ respect to current cancer incidence in US populations Improve the documentation for selection and use of exposure assumptions for sensitivity analyses Commented on the importance of conducting integrated assessments (i.e., cancer and noncancer) &EPA Selected SAB Recommendations SAB Review of 2005 iAs Cancer Assessment (SAB 2007) Concluded that multiple modes of action are likely operable for the effects due to iAs Taiwanese dataset remains the most appropriate for dose- response analysis Epi studies of the US should be critically evaluated based upon a uniform set of criteria Information to determine a non-linear form of the dose- response and the linear default is most appropriate Recommendations regarding specific cancer modeling, exposure assumptions, and corresponding sensitivity analyses Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 12 ------- DO NOT CITE OR QUOTE SEPA United States Environmental Protection Agency Risk Assessment Design (NAS 2009) Issue Problem Concern Objective Is risk assessment the appropriate decision support tool? (Manager) Non-Risk Considerations PLANNING & SCOPING Manage I. St»k«hc4dor, DialoOJ^ Options Identification I Hazard Identification PROBLEM FORMULATION Manager. Assessor, (stakeholder) O3S09U0 Summary Statement Management & Risk Communication XI f "O c Tl OS J 1 o| Conceptual Model Technical Analyas p a S - (Exposure Analysis. Dos*-R«s pons* o Analysis Analysis. Risk Characlemolion) Plan FIGURE 3-1 Schematic representation of the formative stages of risk-assessment design. Doited line in figure denotes that decisions informed by risk assessment will be influenced by nonrisk considerations. Source: Adapted from EPA 1998, 2003. Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 13 ------- DRAFT PLANNING AND SCOPING SUMMARY 14 ------- DO NOT CITE OR QUOTE v>EPA United States Environmental Protection Agency Draft Planning and Scoping Summary for the Inorganic Arsenic (iAs) IRIS Assessment John Cowden U.S. EPA/ORD/NCEA Research Triangle Park, NC Disclaimer: the views expressed in this presentation are those of the speaker and do not necessarily represent the views or policies of the^.S. EPA. xvEPA United States Environmental Protection Agency Key Terminology IRIS Toxicological Review Risk Assessment Hazard identification Dose-response assessment Hazard identification Dose-response assessment Exposure assessment Risk characterization Planning and Scoping Problem Formulation Establishes goals, breadth, depth, and focus of the toxicological review Develops common understanding of why assessment is being developed, how assessment will be used, and data needed to answer key questions Describes specific technical details for the toxicological review Consists of conceptual model and analysis plan Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 15 ------- DO NOT CITE OR QUOTE SEPA United States Environmental Protection Agency NAS Guidance on Planning and Scoping Scoping Elements Considerations Partner and Stakeholder needs Context and purpose Areas of interest Exposure Spatial and temporal considerations Sources and source mitigation Environmental exposure and exposure mitigation Individual intake pathways and individual intake mitigations Hazard Identification Direct and mitigation related hazards and stressors Direct and mitigation-related adverse health outcomes At-risk populations and populations at mitigation- related risk Source: "Science and Decisions: Advancing Risk Assessment;" National Research Council of the National Academies, 2009 Office of Research and Development National Center for Environmental Assessment &EPA Draft Planning and Scoping Summary Agency 1 ** * Considered Limited Consideration Outside the Scope Oral and inhalation exposure Chronic exposure and exposure during susceptible life stages (e.g., in utero) Cancer and non-cancer effects Susceptibility - stressors and potential biomarkers of at-risk populations Impact of uncertainty Exposure sources (e.g., environmental sources and individual intake pathways) - as related to dose-resoonse analysis Arsenic soeciation data - as data inform hazard identification, mode of action analyses, or dose response analyses Bioavailability - as related to dose-resDonse analysis Options for mitigating exposure Health effects related to clinical or ecological mitigation efforts Dose-response analyses for mitigation related health effects Cost benefit analysis on human health effects of iAs exposure or related mitigation efforts Dose-response analysis indicating risk at potential exposure levels (including background levels) Office of Research and Development National Center for Environmental Assessment 31 Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 16 ------- DO NOT CITE OR QUOTE SEPA United States Environmental Protection Agency Developing the Toxicological Review PROPOSED PROCESS PROPOSED DATE Scoping and Problem Formulation Workshop September 2012 Public Stakeholder Workshop January 2013 NAS Public Workshops January 24, 2013 April 4, 2013 Interim NAS Report Fall 2013 Completed Draft iAs Toxicological Review Spring 2014 Complete Internal Agency Review Summer 2014 Complete Interagency Science Consultation Summer 2014 Release draft to External Peer Review (NAS Review) Fall 2014 Complete NAS Review of the iAs Toxicological Review Winter 2015 Complete Internal Agency Review/lnteragency Science Discussion Spring 2016 Post to IRIS Website Summer 2016 Office of Research and Development National Center for Environmental Assessment oEPA s;rSl Pro,cc"on Conclusions > Planning and Scoping Summary DRAFT statement - discussion for Session 4 Context for discussions > Developing the IRIS Toxicological Review Multiple opportunities for public engagement Importance of utility to partners and stakeholders > Next steps Meeting Report Problem Formulation NAS Public Meetings Office of Research and Development Natinnal Hpntpr fnr Fnuirnnmpntal SQtpcsmpnt Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 17 ------- DO NOT CITE OR QUOTE SEPA Additional Context: NAS Recommendations United States Environmental Protection From Formaldehyde review (NAS 2011) Literature search strategy and evaluation criteria (e.g., systematic review) Use HERO database to capture study information and data Unify outcome consideration around common modes of action Weight of evidence evaluation for non-cancer endpoints Sensitivity analyses for reference values and effect of uncertainty factors Harmonize characterization of uncertainty and variability From "Science and Decisions" (NAS 2009) Expand collaboration Implement scoping and problem formulation Criteria to justify alternative assumptions in place of default assumptions Consider feasibility/benefits of options in the design stages Evaluate chemicals in terms of mode of action, background exposure, disease processes, and vulnerable populations Incorporation of probabilistic and distributional methods into dose-response analysis Develop process to communicate and incorporate uncertainty and variability into analysis SEPA Additional context: NAS Recommendations (con't) United States Environmental Protection Agency Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 18 ------- DO NOT CITE OR QUOTE vvEPA Protection Outline United States Environmental Protection > Drafting the IRIS Toxicological Review Draft planning and scoping summary > Developing the IRIS Toxicological Review Proposed timeline oEPA 0 con Draft Planning and Scoping Summary Considered Limited Consideration le Scope Oral and inhalation exposure Chronic exposure and exposure during susceptible life stages (e.g., in utero) Cancer and non-cancer effects Susceptibility - stressors and potential biomarkers of at-risk populations Impact of uncertainty Dose-response analysis indicating risk at potential exposure levels (including background levels) Exposure sources (e.g., environmental sources and HJJHHH individual intake pathways) - as related to dose-response analysis Arsenic speciation data - as data inform hazard identification, mode analyses, or dose ¦¦¦¦¦¦ response analyses Bioavailability - as related to ______ dose-response ¦¦¦¦¦ exposure or re mitigation effo tigating related to logical rts e analyses ¦elated health nalysis on effects of iAs :lated rts Office of Research and Development National Center for Environmental Assessment 37 Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 19 ------- DO NOT CITE OR QUOTE <>EPA Selected NAS Recommendations Environmental Protection Agency From Formaldehyde review (NAS 2011) Literature search strategy and literature evaluation criteria (e.g., systematic review) Weight of evidence evaluation for non-cancer endpoints Use HERO database to capture study information and data Sensitivity analyses for reference values and effect of uncertainty factors Harmonize characterization of uncertainty and variability Unify outcome consideration around common modes of action From "Science and Decisions" (NAS 2009) Expand agency and interagency collaboration Implement scoping and problem formulation Consider feasibility/benefits of options in the design stages Develop process to communicate and incorporate uncertainty and variability into analysis Incorporation of probabilistic and distributional methods into dose-response analysis Evaluate chemicals in terms of mode of action, background exposure, disease processes, and vulnerable populations Criteria to justify alternative assumptions in place of default assumptions Office of Research and Development 39 National flpntpr fnr Fnvimnmpntal A««M«mpnt Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 20 ------- DO NOT CITE OR QUOTE c ERA United States Draft Planning and Scoping Summary Environmental Protection w I w J Agency Scoping Elements Considered Limited Consideration Beyond the Scope Exposure Oral and inhalation exposure Chronic exposure Exposure during susceptible life stages (e.g., in utero) Exposure sources (e.g., environmental sources and individual intake pathways) - as related to dose- response analysis Options for mitigating exposure Hazard Identification Cancer and non- cancer effects Susceptibility- stressors and potential bio markers of at-risk populations Impact of uncertainty Arsenic speciation data - as data inform hazard identification Health effects related to clinical or ecological mitigation efforts Dose-Response Dose-response analysis indicating risk at potential exposure levels (including background levels) Impact of uncertainty Bioavailability- as related to dose- response analysis Arsenic speciation - as related to mode of action/dose-response analysis Dose-response analyses for mitigation related health effects Cost benefit analysis on human health effects of iAs exposure or related mitigation efforts Office of Research and Development National Center for Environmental Assessment Public Stakeholder Workshop to Inform EPA's Upcoming IRIS Toxicological Review of Inorganic Arsenic 21 ------- |