Improved communication among groups Transparency in development of products Harmonization and consistency in risk assessments Shared costs and human resources Guiding Principles of the Alliance 2

Alliance for Risk Assessment (ARA) 3 States, Fed. Agencies, Public Interests, Industry Initiation of Risk Issue Document Draft Peer Reviews Release to Public Risk Information Exchange (RiskIE) Risk Document Development Peer Review & Consult Risk Research And Tools ITER Training and Certification Non-profit Collaborators Alliance “Menu” Options Stakeholder Process Risk Communication Steering Committee ARA Manage- ment Team

RiskIE Risk Information Exchange A Database to Communicate In-Progress Risk & Toxicity Assessments Includes over 5500 projects being conducted by more than 27 organizations representing 13 countries Scheduled to join NLM’s TOXNET in

For More Information Please visit Please visit Or contact the collaborators: Or contact the collaborators: For more information For more information Oliver Kroner Phil Wexler Andrew Rak Chuck Tomlijanovic

7 Extras Slides

A balance of Federal, State, and Tribal governments, Environmental NGOS and non-profits, and Academia. –Anita Meyer, United States Army Corps of Engineers –Barbara Harper, Confederated Tribes of the Umatilla Indian Reservation –Bette Meek, University of Ottawa –Edward Ohanian, United States Environmental Protection Agency –Michael Dourson, Toxicology Excellence for Risk Assessment (TERA) –Michael Honeycutt, Texas Commission on Environmental Quality (TCEQ) –Phil Wexler, National Library of Medicine (NLM) –Ruthann Rudel, Silent Spring –William Hayes, State of Indiana 8 ARA Steering Committee

ARA Fund & Work Flow 9 Federal Agencies, Industry RiskIE ITER Steering Committee States, Tribes, Environmental NGOs ARA Manage TEam ARA Process Funded Projects Unfunded Projects ARA Non-Profit Collaborators

ITER on TOXNET 13 records containing the word “arsenic” found in ITER 10

RiskIE Screenshot 11

Examples of ARA Projects Examples of ARA Projects Risk Document Development: Risk Document Development: Relative Source Contribution for RDX for U.S. Army Research: Research: Dietary arsenic exposure from soil for State of Texas & Hawaii Department of Health Peer Review: Peer Review: Review of 1,3-Butadiene Document Screening Level for Texas Commission on Environmental Quality Tools: Tools: RiskIE & ITER Training: Training: Dose-Response Boot Camp 12

Hawai’i Case Study: Arsenic in Soil 13

StateHELP RiskIE 14

Meanwhile in Texas… RiskIE 15

StateHELP RiskIE 16

This effort does not duplicate ATSDR MRLs, EPA IRIS, FDA ADIs, Health Canada TDIs or RIVM TOCs. ARA supports existing risk values! This effort does not duplicate ATSDR MRLs, EPA IRIS, FDA ADIs, Health Canada TDIs or RIVM TOCs. ARA supports existing risk values! To the contrary, ARA shares resources to avoid duplication because: To the contrary, ARA shares resources to avoid duplication because: –It does not replace individual regulatory processes; ARA users tap in as appropriate. –Many risk values/issues will never be worked by federal groups. –Current federal approaches have resource limitations; thus, new chemicals addressed without duplicate effort. –Update of older values can benefit federal groups as one technical input to internal deliberations. –ARA goes beyond risk values/issues – it is also a shared resource for training and data communication. 17 Does This Effort Duplicate Current Federal Efforts?

ARA mission… ARA mission… –Aligns with many public health goals. –Provides value as a timely resource with enhanced credibility. –Allows stakeholder input. –Harmonizes risk values and methods. Nonprofit corporations demonstrate concept can work (e.g., peer consultation with Voluntary Children’s Chemical Evaluation Program (VCCEP) of EPA). Nonprofit corporations demonstrate concept can work (e.g., peer consultation with Voluntary Children’s Chemical Evaluation Program (VCCEP) of EPA). NLM & TERA success in building ITER; ~200,000 hits per month demonstrates likely value of ARA NLM & TERA success in building ITER; ~200,000 hits per month demonstrates likely value of ARA Aligns with stated needs of stakeholders – e.g., Environmental Council of States (ECOS); Interstate Chemical Clearinghouse. Aligns with stated needs of stakeholders – e.g., Environmental Council of States (ECOS); Interstate Chemical Clearinghouse. 18 Why Do Diverse Groups Fund? Why Do Diverse Groups Fund?

19 The Alliance for Risk Assessment provides: The Alliance for Risk Assessment provides: Credibility Projects are evaluated by the ARA Steering Committee, composed of a broad range of experts from various backgrounds and perspectives. The involvement of diverse interests: enhances credibility enhances credibility ensures careful consideration of all key data and ideas ensures careful consideration of all key data and ideas provides thoughtful management of potential biases provides thoughtful management of potential biases indicates the importance of a project to the broader risk assessment community indicates the importance of a project to the broader risk assessment community

20 The Alliance for Risk Assessment provides: The Alliance for Risk Assessment provides: Sharing of Resources The collaborative nature of the ARA centers on the pooling of resources. ARA participants benefit from access to: Technical resources- ARA provides access to experienced scientists and experts not typically found within a single organization. Technical resources- ARA provides access to experienced scientists and experts not typically found within a single organization. Financial Resources- For organizations with limited funding, ARA offers help covering the costs of a project, and will assist in identifying potential co-sponsors. Financial Resources- For organizations with limited funding, ARA offers help covering the costs of a project, and will assist in identifying potential co-sponsors. Information- ARA participants keep each other informed of their activity, creating opportunities for collaboration. Information- ARA participants keep each other informed of their activity, creating opportunities for collaboration.

21 The Alliance for Risk Assessment provides: The Alliance for Risk Assessment provides: Exposure The ARA encourages the free-flow of information across organizations. Projects that utilize the ARA process will be transparently broadcast within the Risk assessment community via: RiskIE - The Risk Information Exchange is a free internet database that tracks in-progress risk and toxicity assessments RiskIE - The Risk Information Exchange is a free internet database that tracks in-progress risk and toxicity assessments ITER - The International Toxicity Estimates of Risk database lists chronic human health risk values ITER - The International Toxicity Estimates of Risk database lists chronic human health risk values ARA Newsletter/Website- ARA maintains an up-to-date website with descriptions of ongoing projects. Newsletter updates are sent regularly to the risk assessment community ARA Newsletter/Website- ARA maintains an up-to-date website with descriptions of ongoing projects. Newsletter updates are sent regularly to the risk assessment community