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EPA's Integrated Risk Information System: Updates on Process Changes and Assessments

Gina Perovich Deputy Director, IRIS Program U.S. EPA Office of Research and Development

EPA Tools and Resources Webinar November 16, 2016

The views expressed in this presentation do not necessarily represent the views or policies of the U.S. Environmental Protection Agency

Part I

IRIS: Overview and Updates on Process Changes

National Research Council (NRC) recommendations for IRIS (2011)

Enhanced IRIS process (2013) Stakeholder engagement Current efforts

A More Transparent and Systematic Approach to IRIS Assessment Development


Integrated Risk Information System

? IRIS provides information on potential

adverse health effects that may result from exposure to chemical substances found in the environment.

? Toxicity values for effects other than

cancer: Reference Doses (RfDs) and Reference Concentrations (RfCs).

? Cancer risk: Hazard

characterization, Oral Slope Factors, and Inhalation Unit Risks.


? Information is posted on the

IRIS database in the form of an IRIS Summary and Supporting documents (i.e., Toxicological Reviews or IRIS Chemical Assessments).

? IRIS database provides

qualitative and quantitative health effects information on over 550 substances.


IRIS Assessments and Risk Assessment


2011 NRC Recommendations for Developing IRIS Assessments

o In their review of the draft formaldehyde IRIS assessment in 2011, the NRC provided recommendations for improving the development of draft IRIS assessments, in general. For example, the NRC recommended that EPA:

o Provide a fuller discussion of the methods of the assessment; concise statements of criteria used to exclude, include, and advance studies for hazard evaluation and derivation of toxicity values.

o Clearly articulate the rationale and criteria for screening studies and rationale for selecting studies used to calculate toxicity values.

o Use standardized evidence tables to provide methods and results of studies for all health outcomes.

o Use uniform approaches to evaluate strengths and weaknesses of all critical studies and summarize findings in tables.

o Ensure that weight-of-evidence descriptions indicate the various determinants of weight to promote understanding of what elements were emphasized in synthesizing evidence.

o Rigorously edit documents to reduce the volume of text substantially and address redundancies and inconsistencies.

o The NRC did not tell EPA to stop developing IRIS assessments or to stop the IRIS Program until changes

were fully implemented.


New Document Structure

o Concise, rigorously edited assessments (i.e., shorter!) o Preamble to describe methods used o Executive summary that presents the major conclusions and key issues in

the assessment o Detailed literature search strategy and study selection criteria o Distinct separation of hazard identification and dose-response analysis o Evidence tables and exposure-response arrays o Text to focus on analysis and synthesis o Standardized weight-of-evidence characterization for all health effects 6

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