SRA Logo (print)

Society For Risk Analysis Annual Meeting 2008

Risk Analysis: the Science and the Art

Session Schedule & Abstracts

* Disclaimer: All presentations represent the views of the authors, and not the organizations that support their research. Please apply the standard disclaimer that any opinions, findings, and conclusions or recommendations in abstracts, posters, and presentations at the meeting are those of the authors and do not necessarily reflect the views of any other organization or agency. Meeting attendees and authors should be aware that this disclaimer is intended to apply to all abstracts contained in this document. Authors who wish to emphasize this disclaimer should do so in their presentation or poster. In an effort to make the abstracts as concise as possible and easy for meeting participants to read, the abstracts have been formatted such that they exclude references to papers, affiliations, and/or funding sources. Authors who wish to provide attendees with this information should do so in their presentation or poster.

Common abbreviations

A Palette of Scientific Data: Online Risk Assessment Tools

Room: Grand Ballroom E   4:00-5:30 PM

Chair(s): Patricia Nance, Asish Mohapatra

W4-C.1    US FDA CDER's toxicological and adverse human clinical effect databases. Benz RD*; U.S. Food and Drug Administation

Abstract: ICSAS creates toxicological and clinical databases, transforms these data into a format suitable for quantitative structure-activity relationship (QSAR) modeling, evaluates the performance of data mining and QSAR software, and develops and makes publicly available toxicological and adverse clinical effect QSAR prediction models. The goal of ICSAS is to use computer software to predict accurately all toxicological endpoints and adverse clinical effects of chemicals of interest to the FDA, and thereby substantially reduce the need for animal toxicological testing and provide proactive decision support information on potential adverse effects of pharmaceuticals in humans. To date, ICSAS has developed animal toxicological QSAR models to predict: 1) carcinogenicity (24,708 reports on 1,510 chemicals); 2) genetic toxicity (53,104 reports on 8,207 chemicals); 3) reproductive and developmental toxicity (51,724 reports on 2,115 chemicals); 4) phospholipidosis (227 reports on 583 chemicals); 5) maximum tolerated dose (3,925 reports on 1,266 chemicals) and 6) acute toxicity (1,668 reports on 1,273 chemicals). Human data-based QSAR models are now being used by ICSAS to predict: 1) hepatobiliary (120,419 reports on 1,660 chemicals); 2) urinary tract (214,563 reports on 1,660 chemicals); 3) cardiological (396,985 reports on 1,632 chemicals) drug-induced adverse events; and 4) maximum recommended daily dose of pharmaceutical-like molecules (1,246 reports on 1,246 chemicals). Many of the data in ICSAS datasets are available publicly in the open literature, through freedom of information inquiries to FDA and EPA, by subscription to Elsevier's PharmaPendium(tm) database, by purchase of FDA ToxML datasets from Leadscope, Inc., and to Lhasa, Ltd. members through their VITIC database. Proprietary data on unapproved drugs, EPA confidential business information, and data assembled as part of FDA cooperative research and development agreements are not available to the public, however.

W4-C.2    eChemPortal - The global portal to information on chemical substances. Leczynski B*; OPPT, U.S. EPA

Abstract: Phase 1 ( was released to the public in June 2007 by the Organization for Economic Co-operation and Development in collaboration with the European Commission, the United States, Japan, Canada, the World Health Organization (WHO) International Programme on Chemical Safety (IPCS), the United Nation Environment Programme Chemicals (UNEP), the Business and Industry Advisory Committee (BIAC), the International Council of Chemical Associations (ICCA) and environmental non-governmental organizations. eChemPortal is an Internet gateway that provides public access to information on the properties, hazards and risks of chemicals free of charge. It is an integrated system that allows users to simultaneously search multiple databases prepared for government chemical review programs around the world. The High Production Volume Information System (HPVIS) is a partipating database in eChemPortal as well as the respository for information sent into the Agency for the HPV Challenge Program. This presentation will provide an overview of the goals and objectives of eChemPortal including the international events leading to its development, and will describe the search capabilities on chemical names and CAS numbers and those databases participating in Phase 1, and will discuss enhancements to direct searching on chemical properties to follow in Phase 2, now under development.

W4-C.3    Risk Related Databases and other Resources from the US National Library of Medicine (NLM). Wexler p*; National Library of Medicina

Abstract: This presentation will begin with an overview of NLM databases and tools of relevance to toxicology and risk. NLM is among the world’s largest purveyors of free scientific and technical information. The Toxicology and Environmental Health Information Program (TEHIP), established in 1967, provides an array of Web-based databases within and outside its TOXNET system, to help support the risk assessment process. Among these are TOXLINE, a bibliographic files of over 3 million references, and the 5000 chemical record, peer-reviewed, Hazardous Substances Data Bank (HSDB), as well as specialized databases in carcinogenesis, genetic toxicology, toxic releases to the environment, occupational safety and health, household products, dietary supplements, radiation event management, etc. Within the realm of risk assessment per se, TEHIP offers the U.S. EPA’s Integrated Risk Information System (IRIS) and TERA’s Integrated Toxicity for Risk Assessment (ITER) databases, is a partner in the Alliance for Risk Assessment, and will also be adding its Risk Information Exchange (RiskIE) to the TOXNET system in the near future. Other activities, including a new initiative to offer a portal to worldwide sources of information related to toxicology, risk assessment, and related areas, will be discussed. This World Library of Toxicology, Chemical Safety, and Environmental Health (WLT) will provide multi-lingual links to sources of information (governmental, non-governmental, academic, poison control centers, professional societies, databases, legislation, etc.) in toxicology and related disciplines. Produced by Country Correspondents from dozens of countries, the WLT also, provides links to multi-lateral organizations.

W4-C.4    Collaboration and Communication of Global Risk Assessment Information. Wullenweber A, Kroner O, Patterson J*, Wexler P, Rak A, Tomljanovic C; Toxicology Excellence for Risk Assessment; National Library of Medicine; Noblis, Inc.; Concurrent Technologies Corporation

Abstract: With limited resources to keep up with a high demand for risk assessment products, it is critical that existing information is readily available and that risk assessors collaborate during the risk assessment process. Several global risk assessment tools are available to address these issues. First, the Alliance for Risk Assessment (ARA) is a collaboration of organizations dedicated to supporting public health protection by working together on projects to improve the process, efficiency, and quality of risk assessment. Second, the International Toxicity Estimates for Risk (ITER) is a free Internet database of chronic human health risk assessment data from organizations around the world for 620+ chemicals. ITER is available at and on National Library of Medicine’s TOXNET system ( ). Finally, the Risk Information Exchange (RiskIE) is a free Internet database that contains notifications about a variety of human health risk assessment projects that are underway or recently completed. RiskIE is available at and will join ITER on TOXNET. ITER and RiskIE provide risk assessors essential tools for easily identifying and comparing available human health risk data, for sharing in progress risk assessments, and for enhancing interaction among risk assessment groups to decrease duplication of effort. ITER and RiskIE were developed by Toxicology Excellence for Risk Assessment (TERA) and are also resources that support the mission of the ARA by tracking up-to-date information on risk assessment activities.

W4-C.5    Tools for Risk Assessment and Risk Management in Health and Safety in Canada. Abeytunga PK, Whiting R*; Canadian Centre for Occupational Safety and Health

Abstract: Canadian health and safety agencies are putting more emphasis on management systems, risk assessment tools, and risk control programs as ways to reduce injuries and illnesses. Work on on-line tools at CCOHS will be discussed, including the INCHEM and INTOX programs, the CHEMINFO database, a chemical product evaluator, OSH Answers, a risk management system for Canadian workplaces, and "best practices" databases for industry and governments. Also discussed will be other Canadian tools for risk assessment in workplace health and safety, such as tools for job hazard analysis, risk audits, and prevention of musculoskeletal disease (MSD).

W4-C.6    Toxipedia – Toxicology Information for Participatory Risk Assessment. Gilbert S*; Institute of Neurotoxicology & Neurological Disorders

Abstract: A participatory risk assessment risk requires not just exposure and hazard information but also a historical and societal perspective that is readily available to professionals and community members. One of the challenges facing the toxicological and risk assessment sciences is communicating scientific information in a manner that creates an informed public and provides sufficient information to facilitate a risk assessment. Toxicological research provides a seemingly overwhelming, and expanding, amount of information. To keep abreast of the growing amount of information on any one agent or issue, scientists and public health professionals must specialize. Currently there is no easy way for specialist to easily share their knowledge with the public or even other scientists. Toxipedia ( is a new wiki-site concept that is designed to encourage toxicology specialists, risk assessors, and public health professionals to share their knowledge of agents that affect human and environmental health. The goal of Toxipedia is to be a definitive, yet accessible, resource on the hazards and history of chemical and physical agents, regulatory requirements, risk management, and ethical, legal, and social issues related to public health. Toxipedia is a web-based tool for scientific information exchange and communication for the public, the media, students, NGOs, legislators, and professionals that grows as the toxicological and risk sciences advance. The accuracy and credibility of Toxipedia will be supported by subject-specific associate editors using a four-tiered review system. The highest level of review will require peer review, not unlike peer-reviewed professional publications, that can be periodically updated through a rigorous review process. The ultimate goal of Toxipedia is to provide researchers, public health professionals and the public to engage in a participatory assessment of a compounds health effects.

W4-C.7    Developing shared risk assessment resources: A repository of toxicological dose-response data and arrays of available health effect reference values. Woodall GM*; U.S. Environmental Protection Agency

Abstract: There has been an on-going dialogue established to coordinate efforts across multiple agencies within the US federal government (EPA, ATSDR, FDA, OSHA, and others) which use data from dose-response studies to develop human health risk assessments and associated reference values (RfCs, RfDs, MRLs, PELs). Other interested stakeholders that have been involved in these discussions include agencies from other nations, the National Libraries of Medicine, the Department of Homeland Security, the Department of Defense, as well as a number of organizations that develop risk assessments and/or support information management for risk assessments. This talk will highlight some of the efforts directed toward establishing a universally available repository of dose-response toxicological data, thereby providing a cost-effective method to fully use these critical data in risk assessments. Discussion will also cover how the health effect reference values developed by various organizations from these dose-response data - often for disparate applications - relate to one another, and what resources are being developed to help guide the selection of an appropriate reference value. Examples will be provided on how these types of collections of dose-response data and graphical arrays of information are being used in developing the Integrated Science Assessment documents for the National Ambient Air Quality Standards, Toxicological Reviews for the Integrated Risk Information System (IRIS), and on other recent activities to support various programs within and outside the EPA. [The views expressed in this abstract are those of the authors and do not necessarily reflect the views or policies of the U.S. Environmental Protection Agency.]

W4-C.8    SWIFT-DART Knowledgebase Tool (Semantic Web Informatics Facilitated Tool - Dynamic Analysis of Risk Tool). Mohapatra AK*; Health Canada, Safe Environments Directorate, Calgary, Alberta, Canada

Abstract: An emerging framework is proposed to evaluate Health Risk Assessments (HRAs) by Semantic Web Informatics Facilitated Tools (SWIFT) that will integrate, analyze and share HRAs (i.e., hazard characterization, dose response, exposure assessment and risk characterization) data by Dynamic Analysis of these Risk Tools (DART). The SWIFT-DART can be effective by using web 2.0 and 3.0 technologies (e.g., data fusion and data mashups) and by designing it as a knowledgebase tool (i.e., a series of dynamically interlinking databases for health risk assessments of populations and communities). The objective of this tool is to facilitate pro-active public health protection decision making by multiple stakeholders via effective sharing of risk assessment information and resources. Several existing web based risk assessment and toxicology tools and information resources in the context of broader Health Care & Life Sciences (HCLS) stream (e.g., biomedical sciences, molecular biology, toxicology, & genomics) will be critically evaluated. Experts use HCLS data for health assessments, toxico-genomic assessments, drug safety evaluations, and public health surveillance. By effectively correlating and connecting information from various databases, risk assessors can evaluate and assess HRAs and can pro-actively predict the outcome. Risk managers and communicators can effectively manage and communicate health risk, respectively. These tools have practical limitations that can be resolved by effectively sharing information resources and databases. The use of SWIFT-DART will enhance effective collaboration between agencies interested in risk analysis; facilitate knowledge dissemination and sharing; and encourage multi-stakeholders to engage in a dynamic framework for pro-active public health protection. This “work in progress” will seek input from SRA Specialty groups as well as other organizations such as NLM & TERA-ARA. At this time, discussions with NLM are being established.

[back to schedule]