Abstract for TestSmart--A Humane and Efficient Approach to Screening Information Data Sets (SIDS) Data

Chemical Manufacturers Association (CMA) -- Commitment and Approach

Marty Miller
Exxon Biomedical Sciences, Inc.

CMA supports the voluntary HPV program and views this program as an opportunity to demonstrate our commitment to Product Stewardship and Responsible Care® principles. The HPV program attempts to accelerate the work started more than 10 years ago at OECD to develop hazard screening data for HPV chemicals. CMA encourages its member companies to participate in the voluntary program, assists companies in forming consortia in order to share testing costs and expertise, and has developed a tracking system to monitor industry's progress in meeting their voluntary commitments. The HPV program is modeled after the OECD SIDS framework and allows companies flexibility in designing scientifically sound test plans. In order to streamline testing and minimize the use of animals, companies are encouraged to maximize the use of existing data, consider grouping chemicals into categories for testing purposes, use expert judgement and SAR to fill data gaps, use combined test protocols where feasible, and to avoid duplicative testing. CMA also endorses the International Unified Chemical Information Database (IUCLID) system as the preferred format for submitting hazard screening information to EPA.

Overview

Background/History
- CMA and Responsible Care®
- HPV Challenge Framework
CMA Position
Technical Approach
Summary

CMA and Responsible Care®

More Than 200 Member Companies And Partners
Membership Represents about 90% Of U.S. Chemical Industry
Members Must Commit To Responsible Care® Principles
- Establish and maintain information on health, safety, and environ- mental hazards and reasonably foreseeable exposures from new and existing products (Element 4)
- Characterize new and existing products with respect to their hazards using information about health, safety, and environmental hazards, and reasonably foreseeable exposures (Element 5)

Background/History

CMA Endorsed OECD SIDS Program In 1989
- International hazard assessment program (about 4000 HPV)
- Consistent with Responsible Care® and Product Stewardship
- Pace slow... Will take 50 years to complete at current rate
1998 Gore Commits To Accelerate HPV Testing
- Spurred by EDF "Toxic Ignorance" report
- EPA has mandate to implement
- Data will be publicly available... track industry progress
CMA Board Endorses Voluntary Framework

HPV Challenge Framework

CMA Position

Demonstrate Product Stewardship/Responsible Care®
Encourage Voluntary Participation
Leverage Efforts Across Industry And Internationally
Support Use Of Best Science
Allow Adequate Time To Implement Program
Develop Industry Tracking System

Voluntary Testing Benefits

Form Consortia ... Share Testing Burden
Allows Testing Flexibility Of OECD SIDS
- Use of chemical categories/family approach
- Responsible use of (Q)SAR and read-across
- Exemptions where human exposure is limited
Cost Less Than The Test Rule
More Control Over Timing/Ability To Budget
Provide Robust Summaries Vs Lab Reports
Increased Certainty With SIDS In How Data Are Interpreted And Used In Risk Assessment Activities

Technical Approach

Evaluate Adequacy of Existing Data
Define Chemical Categories
Consider (Q)SAR And "Read-across" to Fill Data Gaps
Use Best Science to Develop Sound Test Plans
Consolidate Data and Track Progress

Adequacy of Existing Data

Maximize Use Of Existing Data... Avoid Unnecessary Testing
- Human experience, exposure potential, relevance of test
Allow Expert Judgement/Flexibility
- Base minimum criteria on OECD SIDS guidelines
- Accommodate alternative methods (e.g., petroleum streams)
- Consider physical/chemical properties
- Use appropriate (Q)SAR
Support Reduced Testing For Site-limited Intermediates
Capitalize On IUCLID For Robust Summaries

Chemical Categories

Group Chemicals Based On Structure/Functionality
Maximize Use Of Existing Data/Scientific Knowledge In Category Development
Use Expert Judgement And (Q)SAR To Streamline Testing
Interpolate Within Categories/Extrapolate Across Categories
Build On Existing Categories... Avoid Duplicative Testing Efforts
Share Learnings Of Category Development During Program With Stakeholders

(Q)SAR and Read-Across

Allowed Under OECD SIDS To Fill Data Gap
Based On Model Predictions And Analogous Data
Responsible Use Requires Expert Knowledge
- Model limitations, chemical characteristics, knowledge of production process
Support "Read-across" Based On Toxicological Principles
- Pharmacokinetic/mechanistic considerations
- Similar structural/functional characteristics (e.g., isomers, homologues)
Consider All Data, Including (Q)SAR And Exposure Potential, For Testing Exemptions

Test Plans

Consider All Available Data in Study Design
Include In Vitro Methods And Modeling To Develop/Evaluate Testing Strategies
Combine Endpoints Where Feasible
Harmonize Efforts to Avoid Duplicative Testing
Need Good-faith Technical Review And Alignment On Use Of Test Information

Test Data Submissions

Database For New And Existing Tox Data
- Publicly available
- Managed by EPA
- Robust summaries, not full reports
- Endorse IUCLID as data repository

Proposed Data Gathering Tool

Summary

Endorse Voluntary Testing Program
Adhere To OECD SIDS Guidelines
Maximize Use Of Existing Data To Reduce Animal/Chemical Testing
Support Responsible Use Of Categories And Read-across
Harmonize Efforts To Avoid Duplicative Testing
Develop Scientifically Sound Test Plans
Demonstrate Product Stewardship/Responsible Care®

TestSmart HPV