December 12 - 13, 2013

COMMENTS FOR THE DECEMBER EPA BIMONTHLY MEETING: ETHYLENE OXIDE

Kimberly Wise, PhD

ACC Center for Advancing Risk Assessment Science and Policy (ARASP)
Center for Advancing Risk Assessment Science and Policy

http://www.americanchemistry.com/ARASP

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Promotes

 Development and Application of Scientifically Sound 

Methods

 Transparent and Explicit Data Evaluation Criteria 

 Adoption of Policies and Practices that Use Best 

Available and Relevant Science 

 Use of Mode of Action (MOA) Information
IRIS in 2013 Program

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2013 IRIS Process Update

Enhancements

Announced

 Scoping and 

Problem 

formulation

 Release of 

Lit Search 

and Evidence 

Tables

 Early ID of 

Science 

Issues

 Stopping 

Rules
Continual Improvement of IRIS

Data 

Acquisition 

Study 

Evaluation

Study 

Integration

 Increasing Transparency, Objectivity, and Consistency

 Timely Implementation of All NRC Recommendations
Improving 

Ethylene Oxide 

Assessment

Complete Data Quality Evaluations

 Provide the criteria for evaluating the 

quality of epidemiology, toxicology and 

mechanistic studies

 Provide suitable definitions for what 

constitutes a determination of “highquality”

 Describe the elements of the study that 

have increased or decreased its quality

Revise Evidence Tables

 Align studies and data in the order deemed 

most relevant to supporting the weight of 

evidence conclusions

 Add column which identifies the quality 

determination of the study
Improving 

Ethylene Oxide 

Assessment

Address Endogenous Exposures

 Include discussion of ambient EtO exposure 

levels in relation to the derived unit risk

 Include discussion of homeostatic 

mechanisms that exist at typical EtO 

endogenous exposure levels

Robust Peer Review

 Present both linear and non-linear models in 

the assessment and develop relevant risk 

estimates based on each model.

 Identify an “honest broker” to ensure the 

disposition of public comments and peer 

review recommendations
December 12 - 13, 2013

COMMENTS FOR THE DECEMBER EPA BIMONTHLY MEETING: BENZO(A)PYRENE

Kimberly Wise, PhD

ACC Center for Advancing Risk Assessment Science and Policy (ARASP)
Improving IRIS

High Quality Chemical Assessments

Accountability

Transparency

Consistency
Key Areas for Enhancement

Enhancing 

IRIS

Data 

Acquisition

Data 

Evaluation 

and 

Integration

Peer 

Review
Improving 

Benzo[a]pyrene 

Assessment

Conduct Problem Formulation

 Identify the goals and scope of a BaP 

assessment

 Discuss the potential areas of concern for 

human health associated with relevant BaP 

exposure levels

Complete Data Quality Evaluations

 Clearly identify whether EPA considers the 

study to be of high, medium or low quality. 

 Clearly identify study quality characteristics 

and describe how each of the studies meets, 

or does not meet, these criteria (e.g. for 

animal data, such criteria could include a 

clear evaluation of study design, sample 

size, statistical power, and the doseresponse and exposure characterization)

 Include discussion of how the quality 

evaluation influenced a study’s use in the 

weight of evidence evaluation
Improving 

Benzo[a]pyrene 

Assessment

Revise Evidence Tables

 Present all the data, positive and negative, 

equally within the evidence table

Improve Systematic Review

 Include all relevant information (e.g. studies 

involving exposure to BaP via the use of coal tar 

pharmaceuticals) 

 Integrate all the information and explain why a 

decrease in anxiety, as measured in animal 

models, should be considered an adverse effect

 Provide a realistic timeline for completing and 

fully implementing all of the NRC 

recommendations

Robust Peer Review

 Include experts in dermal dosimetry on the peer 

review panel to evaluate the EPA’s dermal slope 

factor and associated methodology
Summary

Path-forward

Clear, 

Objective 

Processes 

Early 

Stakeholder 

Engagement

Solid Process 

for 

Addressing 

Peer Review 

Comments 

Scientifically 

Defensible, 

High Quality 

Assessments