The ILSI Research Foundation Center for Risk Science Innovation and Application (RSIA) uses international, stakeholder-balanced expert groups to develop and apply decision approaches, focusing resources where they matter most for public health.
The Challenge
Diminishing availability of natural resources, growing populations, and increasing financial constraints put pressure on society to achieve more with less in ensuring human safety and well-being. We must recognize these mounting limitations when developing and using decision-support methods critical to effective risk management. New approaches, created with the understanding resources are likely to remain scarce, must be considered in order to maintain and improve health.
The Response
RSIA seeks unmet needs in human health risk management where application of new methods and approaches will reduce waste and improve health.
We use a network of experts who provide a range of perspectives on the issues we address, which fosters productive and rewarding scientific dialogue. Government, civil society organizations, industry, academia, health and professional groups, international organizations – come together at the Center to collectively identify and solve health issues of common interested so that everyone involved is proud of the quality of the scientific output. At RSIA projects are designed, vetted, and steered by independent and highly respected experts from differing but balanced viewpoints. The process is transparent to all stakeholders from beginning to end. In this way, the Center ensures output of frameworks, data, and methods that are accepted and used by all.
RSIA Programs and Projects
Guidelines for Efficient Water Use in the Food and Beverage Industry
The goal of the Guidelines for Efficient Water Use in the Food and Beverage Industry project is to establish internationally acceptable guidelines leading to a more efficient reuse of water in food and beverage production and to improve environmental outcomes associated with wastewater discharge. The Guidelines will help improve water safety and reduce overall water consumption.
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Antimicrobial Threshold of Toxicological Concern
The Antimicrobial TTC project is a collaborative effort with the American Chemistry Council, the US Environmental Protection Agency (EPA), and the US Food and Drug Administration. Its goal is to develop a TTC approach to determine what data are needed to support the development and regulation of safe products and will include 1) creation of a reference database building on EPA’s ToxRef Database and 2) design of a tiered approach to estimate systemic dose for dermal exposure from existing oral exposure toxicity databases.
Risk of Risk Perception
Human perception of risk can lead to behavior that reduces health risk (avoids a risk); increases health risk (replaces an avoided risk with something riskier); or does not affect health risk, but has adverse economic effects. RSIA convened a workshop of senior risk perception, risk policy, and economics experts from government and academia and representatives from major news media, environmental and food safety NGOs, and leading industries to explore public health risks stemming from errant perceptions of risk. RSIA will publish a summary of the workshop findings, initiate a second workshop to further examine risk perception, and conduct case studies to help identify measurement approaches to address public health risks from perceptions of risk.
NanoRelease
ILSI Research Foundation is excited to announce a multi-stakeholder project that will explore current understanding of methods for measuring release of nanomaterials from coatings and objects used in commercial products. The participants in the initial Steering Committee for the effort include experts from government agencies in US and Canada, leading companies, and non-government organizations. The Research Foundation anticipates the project will develop "state of the science" understanding of the potential for release of nanomaterials, and then take the science to the next level through round-robin testing and methods development across government, industry, and academic laboratories. It is hoped that the project will build confidence in decisions about sustainable nanomaterial selection.
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NanoCharacter
Despite numerous attempts to define standard characterization and reporting for nanomaterials, recent analyses of the literature show very little overlap of how materials are characterized from one study to the next. This lack of consistency wastes resources because weight of evidence cannot be developed across studies. It also places regulatory agencies nationally and internationally at odds with each other as they each try to develop standards on what information to ask for in submissions. The barriers to progress from these past attempts include a) lack of coordination across organizational structures, individual interests, and differing discipline needs, and b) a bewildering array of timelines for funding, technical development, policy, and regulatory enforcement. The NanoCharacter project brings together the leaders of efforts to develop a practical framework and roadmap for establishing widespread use of characterization and reporting standards for studies of nanomaterials.
Global Threshold Project
ILSI Research Foundation’s Global Threshold Project convened an expert working group charged with analyzing the fundamental biological processes underlying human health effects from four broad categories of agents: chemicals, microbial pathogens, allergens, and nutrients. Out of this discussion has come the Key Events Dose-response Framework, a cross-disciplinary mode-of-action based analytical approach that systematically examines key (and necessary) biological and chemical events along the pathway between exposure/intake and the ultimate effect of concern.
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Developmental Toxicity Database
Public health researchers and regulators need scientifically based strategies to screen, and prioritize for testing, the large number of environmental substances that have not been adequately assessed for safety. Some of these substances may pose a risk to the developing fetus. The initial impetus for this Developmental Toxicity database was an ILSI Research Foundation workshop report on the potential value of statistically-based structure-activity relationship (SAR) models as tools for prioritizing chemical substances for further study. That report concluded that refined approaches for utilizing in vivo toxicity data would greatly enhance the value of SAR models for developmental toxicity; however, the development of such approaches would require a robust collection of data. In response, ILSI Research Foundation initiated a project to develop a prototype database.
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CARES
CARES is a state-of-the-art software program designed to conduct complex exposure and risk assessments for pesticides, such as the assessments required under the 1996 Food Quality Protection Act (FQPA). CARES was originally developed under the auspices of CropLife America (CLA), which conceived the project, provided funding, and oversaw the program’s evolution. Scientific and technical contributions to the program’s development came from a broad team of experts, including scientists from CLA’s member companies and staff, consulting companies, and the US Environmental Protection Agency and US Department of Agriculture. With its transfer to the ILSI Research Foundation, the CARES program and source code will continue to be publicly available at no charge.
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Physiological Parameters Database
The ILSI Research Foundation database of human physiological parameters for early life stages was completed and posted on the ILSI website in 2008. The database is a reference source of appropriate parameter values for physiologically-based pharmacokinetic (PBPK) or biologically-based dose-response (BBDR) models and subsequent use in risk assessment. The US Environmental Protection Agency (EPA) has now updated and combined the early life stage data with physiological data for later life stages, and the comprehensive Physiological Information Database is freely available for download from the EPA website.
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Direct Access to the Database (Redirect to EPA)
Biodegradation SEP Panel
The ILSI Research Foundation has been selected to organize and administer the work of a Peer Consultation Panel to evaluate data and make recommendations to the U.S. Environmental Protection Agency (EPA) regarding biodegradation studies on certain fluorotelomer products. This work is mandated under the Fluorotelomer-Based Product Biodegradation Testing Supplemental Environmental Project (Biodegradation SEP) which E.I. DuPont de Nemours and Company (DuPont) has agreed to perform pursuant to the Consent Agreement and Final Order (CAFO) entered into between DuPont and EPA. The ILSI Research Foundation has been selected as Panel Administrator for this Project. The Panel will be charged with review and evaluation of data from analytical characterization and biodegradation studies and will provide input to EPA on an advisory basis.
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