Proof-of-concept case study integrating publicly available information to screen candidates for chemical prioritization under TSCA / USA Environmental Protection Agency.

Format:

Book

Contributor:

USA Environmental Protection Agency, editor.

Language:

English

Subjects (All):

Information storage and retrieval systems.

Information storage and retrieval systems--Design.

Physical Description:

1 online resource

Place of Publication:

Washington, D.C. : U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Office of Research and Development, 2021.

Summary:

Regulatory agencies worldwide are looking to efficiently integrate information on chemical substances in order to inform priorities for decisions and data requests. This document updates the US Environmental Protection Agency's (EPA) long-term strategy described in the Working Approach for Identifying Potential Candidate Chemicals for Prioritization and presents the Public Information Curation and Synthesis (PICS) approach that integrates publicly-available hazard, exposure, persistence, and bioaccumulation information for chemical substances. The purpose of the PICS approach is to synthesize information from traditional and new approach methods (NAMs) to understand the overall degree of potential concern as well as the relative coverage of potentially relevant human health and ecological toxicity and exposure information that could inform level of effort and resources that may be needed to evaluate that specific chemical substance. The PICS approach is based on two dimensions. The first dimension, Scientific Domain Metric (SDM), encompasses the synthesis of the traditional and NAM data to understand the overall degree of potential concern related to human health and the environment. The second dimension, Information Availability Metric (IAM), reflects the relative coverage of potentially relevant human health and ecological toxicity and exposure information that could inform level of effort and resources that may be needed to evaluate that specific chemical substance. The PICS approach is not designed to replace the prioritization process described in TSCA but aims to increase efficiency and focus expert review on chemical substances that may have a greater potential for designation as a high- or low priority candidate. A proof-of-concept case study was performed by applying the PICS approach to a subset of the TSCA active inventory. The results demonstrate that the approach discriminated between high- and low priority candidate chemical substances and identified potential information gaps. The PICS approach may be applied to large numbers of chemical substances and is an important tool for efficiently integrating and synthesizing large amounts of publicly available information, and aspects of the approach could be adapted and applied to other prioritization decision contexts.

Contents:

Acknowledgements

Disclaimer

Reviewers

List of Abbreviations and Acronyms

1. Executive Summary

2. Introduction

3. Background

3.1. Development and Implementation of New Approach Methods Under TSCA

3.2. Evaluating Existing Chemicals Under TSCA

3.3. Public Engagement

4. Public Information Curation and Synthesis (PICS) Approach

4.1. Overview of the PICS Approach

4.2. What the PICS Approach is Intended to Accomplish

4.3. What the PICS Approach is Not Intended to Accomplish

5. A Proof-of-Concept Case Study

5.1. Chemical Substance Selection, Curation and Quality Control

5.2. Scientific Domain Metric Assessment

5.3. Scientific Domain Metric Calculation

5.4. Information Availability Metric

5.5. Results of the Proof-of-Concept Analysis

5.6. Overall Limitations and Long-term Options

6. Summary

7. Conclusion

Appendix A. Proof-of-Concept (POC) Subset of the Non-confidential TSCA Active Inventory

Appendix B. Detailed Information on Data Sources used in the PICS Approach

Appendix C. Quality Assurance Recommendations to Efficiently Review Datasets to Support Candidate Chemical Identification for TSCA

Appendix D. Definition of Exposure Pathways for Calculating the Susceptible Population Domain Metric

Appendix E. Public Information Curation and Synthesis (PICS) Output for Proof-of-Concept (POC) Subset of the Non-confidential TSCA Active Inventory

Appendix F. Comparison of Individual Scientific Domain Metrics for the POC238 and Non-confidential TSCA Active Inventory

Appendix G. Information Availability Metric Calculation

PEER REVIEW PLAN

EPA Response to External Peer Review of A Proof-of-Concept Case Study Integrating Publicly Available Information to Screen Candidates for Chemical Pre- Prioritization under TSCA (TSCA POC)

Peer Review Report.

Notes:

Description based on publisher supplied metadata and other sources.