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Mission

A process to facilitate communication and collaboration toward development of useful and timely risk science products. Mission.

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Mission

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  1. A process to facilitate communication and collaboration toward development of useful and timely risk science products.

  2. Mission The Alliance for Risk Assessment (ARA) is a collaborative effort of organizations dedicated to supporting public health protection by improving the process and efficiency of risk assessment. Given a limited supply of time, resources, and expertise, public health protection is an effort that benefits from cooperation, organization, and prioritization.  To this end, the ARA provides a framework for the advancement of risk assessment by: • implementing a multi-stakeholder decision-making process to deliver the best use of science with openness and transparency  • enabling groups with limited resources access to toxicological and risk assessment expertise • facilitating the harmonization of risk assessment procedures across organizational lines • increasing the capacity for developing risk information by pooling technical and financial resources to ensure their most effective applications, by minimizing duplication of effort • promoting the use of risk assessment by fostering the exchange and dissemination of information

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

  4. ARA Tools International Toxicity Estimates for Risk Database (ITER) • Free internet database of human health risk values and cancer classifications from a variety of national and international organizations, as well as independent groups • Currently contains risk values for more than 600 chemicals, and is part of the National Library of Medicine’s TOXNET compilation of databases • Only database that presents risk data in a tabular format for easy comparison • Risk values or documents developed under this alliance will be published on ITER after appropriate peer review and approval of the risk values/documents. • This will ensure that new credible risk values developed by both State regulatory agencies and independent groups are widely available to interested parties.  • In addition, peer reviewed risk values already developed by State agencies and independent groups can be uploaded to ITER to foster data sharing.  • The inclusion of individual state’s risk assessment values on ITER would facilitate sharing of information between state and/or local agencies.  

  5. Risk Issues Document Development • Need for new risk assessment issues documents will be identified by reviewing existing assessments (including coordination through HNS), sharing internal priorities among funding partners and State groups, and evaluating requests made by interested parties.   • For assessments not currently under development, non-profit risk assessment consultancies and academic centers could author such documents for use by the broader risk assessment community.  • Assessments will be conducted according to generally-accepted state-of-the science methods • Newly developed risk assessment values will be posted on ITER after appropriate peer review and acceptance of proposed values.

  6. Peer Consultation • conducted by an expert panel comprised of a core group of highly experienced risk assessment scientists from various organizations • Specific experts will address data interpretation issues and provide scientific judgments during document development.  • Individuals from State, academia, public interest groups, and industry.  • The core group will develop and apply a consistent approach to addressing issues encountered in the development of risk values.  • The purpose of this group is to ensure that the documentation meets basic requirements, to apply a consistent approach to addressing generic issues, and to identify key chemical-specific issues that would be useful to highlight during the next step of peer review.  • After the peer consultation, the document authors will revise the document, which can then be submitted for peer review.

  7. Peer Review • A peer review process will be established to address the higher-level, chemical-specific issues that are part of the assessment, and to reach a consensus position on the appropriate risk values or interpretations.  • The peer review panel consists of ad hoc members convened to address issues specific to the chemical or issue at hand, and would include chemical-specific experts, and experts on issues key to the specific assessment.  

  8. Training • Develop a mechanism for risk assessment training • Formal training courses and “hands-on” experiences.  • Formal training courses would be conducted for state, provincial, tribal, funding partners, and other interested risk assessors on a variety of topics

  9. ARA Work Flow Steering Committee Federal Agencies, Industry Funded Projects Risk Information Exchange (RiskIE) TERA and Non-Profit Collaborators States, Tribes, Env. NGOs Unfunded Project Requests ITER

  10. ARA Funds Flow ARA Process Federal Agencies Federal Funds Federal Funds Unfunded Projects 100 Risk Issues per Year by Year 5 Contracts Funded Projects Industry Contracts

  11. ARA Steering Committee • Provides advice to ARA Partners on mission- relatedness, project prioritization, Conflict of Interest, • Scientists: • 2 States • 1 Tribe • 1 Env. Group • 2 Federal • 1 Industry • 1 Academic • 2 ARA Partners

  12. Key Benefits of Collaboration • Promotes science-based decision making to protect human health by ensuring all key data and ideas are fully considered • Enhances harmonization and consistency in risk assessments thru an open, transparent, multi-stakeholder approach that ultimately foster harmonization and information sharing • Makes use of groups of experts that are normally not available within a single organization • Shares costs and human resources among multiple stakeholders to increase output for the broader risk community • This can all be achieved while allowing groups to control their own process and can receive broad acceptance with thoughtful management of biases

  13. Why Would Diverse Groups Provide Funding? • The Alliance for Risk Assessment (ARA) mission… • Aligns with many public health goals. • Provides value as a timely resource for technical products with enhanced credibility. • Allows Stakeholder input – e.g., via involvement in Science Steering Committee, as participants in technical panels. • Gives an opportunity for harmonizing risk values and methods – which eases burden for stakeholders that must meet requirements in multiple constituencies. • Over the years nonprofit corporations have demonstrated the concept can work [e.g., peer consultation with Voluntary Children’s Chemical Evaluation Program (VCCEP) of EPA]. • NLM & TERA have 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) call for harmonized process.

  14. Does Stakeholder Interest Exist? • In exploring the needs for this ARA, TERA has provided briefing and/or received input from many potential stakeholders (over 150 individuals) Including: • 20 States • 2 Tribes • 4 Environmental NGO’s • 30 Industry groups • 6 U.S. Federal Agencies • 4 Countries • Feed back has been positive. Suggestions have led to refinements in the proposed ARA. Nearly all responding contacts have encouraged moving forward. • Diverse groups are beginning to provide funding or suggest projects

  15. NLM’s Toxnet

  16. Does This Effort Duplicate Current Federal Efforts? • This effort does not duplicate ATSDR MRLs, EPA IRIS, FDA ADIs, Health Canada TDIs or RIVM TOCs. • 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. ARA Supports Existing Risk Values • Provides guidance for sources of toxicity information that may be used in performing human health risk assessments • ITER can supplement existing toxicity data • ARA can provide Tier III values EPA OSWER Directive 9285.7-53

  18. Why Would Diverse Groups Provide Funding? • The Alliance for Risk Assessment (ARA) mission… • Aligns with many public health goals. • Provides value as a timely resource for technical products with enhanced credibility. • Allows Stakeholder input – e.g., via involvement in Science Steering Committee, as participants in technical panels. • Gives an opportunity for harmonizing risk values and methods – which eases burden for stakeholders that must meet requirements in multiple constituencies. • Over the years nonprofit corporations have demonstrated the concept can work [e.g., peer consultation with Voluntary Children’s Chemical Evaluation Program (VCCEP) of EPA]. • NLM & TERA have success in building ITER; ~200,000 hits per year demonstrates likely value of ARA • Aligns with stated needs of stakeholders – e.g., Environmental Council of States (ECOS) call for harmonized process.

  19. Why a non-profit? From a government perspective, non-profit status has four benefits: • Independence / Objectivity. We are chartered to operate and act free of commercial or political bias, so we take an objective stance. • Superior Value. All monies go to supporting our mission, allowing us to devote the greatest resources to our work and delivering the highest value for the government dollar. • Usable Results. We are outcome driven and results oriented; our value is measured by the utility of our work—we help sponsoring organizations make a difference. • Kindred Spirit. We share the spirit of public service; we understand the inner workings and detailed tasks that are the key to achieving progress.

  20. Key Benefits of the Alliance • Promotes science-based decision making to protect human health • Enhances harmonization and consistency in risk assessments thru an open, transparent, multi-stakeholder approach • Provides user control of own process, while providing parallel process for shared help. • Maintains essential core group of experts that are normally not available within a single agency or state • Shares costs and human resources among multiple stakeholders to increase output

  21. www.allianceforrisk.org

  22. Contact Us Toxicology Excellence for Risk Assessment (TERA) Dr. Andrew Maier maier@tera.org 513-542-7475 x23 Concurrent Technologies Corporation (CTC) Chuck Tomlijanovic chuck-t@ctc.com 814-269-6834 National Library of Medicine Philip Wexler wexlerp@mail.nlm.nih.gov 301-496-6346 Noblis Andrew Rak Andrew.rak@noblis.org 703-610-2166

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