EPA’s Integrated Risk Information System (IRIS) IRIS Process, Opportunities for Stakeholder Engagement Xabier Arzuaga, PhD Toxicologist, IRIS Program U.S. Environmental Protection Agency NIEHS-SRP Annual Meeting November 18-20, 2015 The views expressed in this presentation do not necessarily represent the views or policies of the U.S. Environmental Protection Agency
Overview o Review risk assessment process o Integrated Risk Information System (IRIS) o IRIS process o Opportunities for stakeholder engagement in the process o Examples: comments and recommendations received during public science meetings 2
EPA’s Definition of Risk Assessment Risk assessment: Qualitative and quantitative evaluation of the risk posed to human health and/or the environment by the actual or potential presence and/or use of specific pollutants. From EPA’s “Terms of Environment” Glossary 3
Overview of Human Health Risk Assessment Information Information RISK RISK RESEARCH ASSESSMENT MANAGEMENT Epidemiology Planning & Scoping D Risk char Ban Clinical Studies Hazard Identification E More research Animal Studies C Social Standards : Dose-Response o Species, exposure, etc. I air, water, food S.A.R. (Structure Activity S Assessment Economic Priorities : I Relationships) research, Exposure Assessment Modeling O Legal regulation N Research Assessment Needs Needs 4
IRIS: Human Health Hazard Assessments EPA's Integrated Risk Information System (IRIS) is a human health assessment program o that evaluates information on effects that may result from exposure to environmental contaminants. Multidisciplinary scientists critically review publicly available epidemiologic and o experimental studies and create scientific reports known as IRIS Toxicological Reviews that: Identify adverse health effects of chemicals in the environment (e.g., reproductive effects, cancer, immune effects, etc). Estimate the amount of a chemical that people can be exposed to daily without facing an appreciable risk of harmful health effects other than cancer. Characterize the potential for a chemical to cause cancer in people (e.g., carcinogenic to humans, likely carcinogenic to humans, etc). Estimate the excess risk of cancer that people face from exposure to a chemical over the course of a lifetime (oral and/or inhalation). These assessments are available to the public on the IRIS database. o 5
IRIS Assessments o IRIS assessments systematically review the publicly-available peer-reviewed studies to Identify adverse health outcomes Characterize exposure-response relationships DOSE-RESPONSE HAZARD ASSESSMENT IDENTIFICATION Characterize exposure- RISK Which health RISK response relationships outcomes are CHARACTERIZATION MANAGEMENT Account for high-to-low-dose, caused by the Integrate HAZARD, animal-to-human, route-to- Analyze and agent? DOSE-RESPONSE, route, and other differences compare and EXPOSURE options Select an EXPOSURE ASSESSMENT appropriate LEGAL How do people come in contact action POLITICAL with the agent? How much are they exposed to? SOCIAL ECONOMIC TECHNICAL CONSIDERATIONS 6
Chemicals Nominated for IRIS Assessment The IRIS program submits queries to EPA Program Offices and Regions and the public for o nominations. Substances selected based on one or more of the following factors: o Potential public health impact; EPA statutory, regulatory, or program-specific implementation needs; Availability of new scientific information or methodology that might significantly change the current IRIS information; Interest to other governmental agencies or the public; and Availability of other scientific assessment documents that could serve as a basis for an IRIS assessment. The decision to assess depends on available Agency resources. Availability of risk o assessment guidance, guidelines, and science policy decisions may also have an impact on the timing of EPA's decision to assess a chemical substance. The list of new or updated assessments is published in the Federal Register (FR) as part of o the IRIS agenda. 7
Develop Review Finalize Scoping and Agency Review Revise Assessment Problem Formation Review by health Address peer review and scientists in EPA’s • Scoping: Identify needs public comments of EPA’s program and program and regional offices regional offices • Problem formulation: Final Agency Review Frame scientific and Interagency questions specific to the Interagency Science Science Discussion assessment Consultation Discuss with EPA health Draft Development Review by other federal scientists and with other Apply principles of agencies and Executive federal agencies and Office of the President systematic review to: Executive Office of the • Identify pertinent studies President • Evaluate study methods and quality Public Comment • Integrate evidence for Post Final each health outcome Release for public review Assessment • Select studies for and comment deriving toxicity values Post to IRIS website • Derive toxicity values External Peer Review Release for independent external peer review 8 I R I S A S S E S S M E N T D E V E L O P M E N T P R O C E S S The 7-step process has not changed. This figure refines earlier versions and includes the 2013 IRIS enhancements and the incorporation of systematic review approaches.
1. Scoping and Problem Formulation & Draft Development Internal planning and scoping meeting to identify EPA needs. o Conducts public meeting on technical problem formulation. Conducts literature search and study selection. o Convenes public meeting to discuss literature search, evidence tables, exposure-response figures, and key issues. Implements systematic review recommendations from the o National Research Council. Identifies hazards, selects studies for dose-response, derives o toxicity values, prepares draft assessments. 9
2. Agency Review o Shares draft assessment with EPA’s program and regional offices. o Convenes a meeting to discuss draft assessment o Identifies science issues o Determines needed disciplines of peer review panel members and scope of external peer review. 10
3. Interagency Science Consultation o Shares draft assessment with other Federal Agencies and the Executive Office of the President (EOP) for science consultation. o Convenes a meeting of other Federal Agencies and EOP. o Revises draft assessment as appropriate. 11
4. Public Comment and External Peer Review o Publicly releases of draft assessment and peer review charge on IRIS Website. o Convenes public meeting on draft assessment. o Discusses draft materials and science issues at public meetings. o May revise draft assessment and peer review charge. o Submits draft IRIS assessment and peer review charge questions to external peer review panel. o Participates in public peer review meeting. 12
5. Revise Assessment o Evaluates external peer review recommendations and all public comments. o Revises draft assessment, as appropriate. o Develops a disposition of peer review and public comments. 13
6. Final Agency Review and Interagency Science Discussion o Sends final draft assessment for final internal review by EPA Program and Regional Offices. o Provides other Federal Agencies and EOP with final draft assessment and related materials. o Convenes a meeting other Federal Agencies and EOP to discuss final comments. 14
7. Post Final Assessment o Completes the IRIS Assessment. Including Toxicological Review IRIS Summary and any appendices o Post final IRIS assessment and related materials to IRIS Website. 15
Opportunities for Stakeholder Engagement Scoping and Agency Review Revise Assessment Public meeting Problem Formation Review by health Address peer review and on problem scientists in EPA’s • Scoping: Identify needs public comments formulation of EPA’s program and program and regional offices regional offices • Problem formulation: Final Agency Review Frame scientific and Interagency questions specific to the Interagency Science Science Discussion assessment Consultation Discuss with EPA health Draft Development Review by other federal scientists and with other agencies and Executive Apply principles of federal agencies and systematic review to: Office of the President Executive Office of the • Identify pertinent studies President • Evaluate study methods and quality Public Comment • Integrate evidence for Post Final each health outcome Release for public review Public meeting Assessment • Select studies for and comment deriving toxicity values on literature Post to IRIS website External Peer • Derive toxicity values search, key Review science issues Release for independent external peer review Public review and comment period and meeting – the public can address the peer reviewers 16
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