## December 12

- 13, 2013

COMMENTS FOR THE DECEMBER EPA BI

MONTHLY 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

2 

# 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

3 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 “high

quality ”



###  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 BI

MONTHLY 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 dose

response 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