The fourth colloquium in the Society of Toxicology (SOT) and US Food and Drug Administration (FDA) Colloquia on Emerging Toxicological Science Challenges in Food and Ingredient Safety series will be held on June 17, 2015, and feature “Contemporary Issues in Risk Assessment.” Participants can register for the onsite event at Wiley Auditorium, College Park, Maryland, or join the webcast. The program will start at 8:15 am USA Eastern Time and conclude at 12:30 pm.
The National Academies of Sciences report “Science and Decisions: Advancing Risk Assessment” (National Research Council, 2009) recommended that “risk assessment should be viewed as a method for evaluating the relative merits of various options for managing risk rather than an end in itself.” How can the federal government best accomplish this goal? This SOT FDA colloquium will focus on recent improvements in the practice of human health assessments. Exciting advances in the methods and best practices, consistent with the advice from the National Academies, have been made in recent years and implemented by a number of stakeholders.
This session will cover the lessons learned from (1) problem formulation and protocol development in chemical-specific human health assessments; (2) evidence identification and transparent criteria for inclusion and exclusion of the individual studies in the assessment; (3) harmonization of the cancer and non-cancer dose-response assessments; and (4) the use of the mechanistic data in support of human health assessments. Moreover, this colloquium will demonstrate tangible examples of the implementation of the best practices in risk assessment to illustrate how the field is evolving to meet the needs of various stakeholders.
Suzanne Fitzpatrick, US FDA, College Park, Maryland, is the chair of the session, four featured speakers will present perspectives on risk assessment issues, and Ivan Rusyn, Texas A&M University, College Station, Texas, will moderate the concluding panel discussion. Speakers and presentations include the following.
Problem Formulation and Scoping for Human Health Assessments
Juleen Lam, University of California San Francisco, San Francisco, California
Dr. Lam has over a decade of experience in environmental health research and policy, holding positions at state and federal government agencies, academic institutions, and in the consulting and nonprofit sectors. Currently, she is an Associate Research Scientist in the Program on Reproductive Health and the Environment, Department of OBGYN and Reproductive Sciences, University of California at San Francisco. Previously, she was in the Department of Health, Policy and Management at the Bloomberg School of Public Health at Johns Hopkins University. She completed two postdoctoral fellowships: at Johns Hopkins University and the US Environmental Protection Agency. She specializes in analysis of environmental health data, development, and application of risk assessment methods as well as the translation of scientific findings into making timely and informed decisions and policies.
Identification and Selection of the Evidence Base for Human Health Assessments
Kathryn Guyton, International Agency for Research on Cancer Monographs Programme, Lyon, France
At the International Agency for Research on Cancer (IARC), World Health Organization, Dr. Guyton contributes expertise in cancer mechanisms to the IARC Monographs Programme. IARC Monographs identify environmental factors that can increase the risk of human cancer, providing scientific information that is used worldwide to support actions to prevent exposure to potential carcinogens. Prior to joining IARC, she contributed to IRIS assessments of prevalent environmental contaminants at the US Environmental Protection Agency (2005–2014). As the Director of Scientific Affairs at CCS Associates (1998–2005), she worked with the US National Cancer Institute in cancer screening, prevention, treatment, and imaging.
Harmonizing Dose-Response Assessment for Cancer and Non-Cancer Endpoints in Human Health Assessments
Weihsueh Chiu, Texas A&M University, College Station, Texas
Dr. Chiu pioneered the use of probabilistic methods for characterizing uncertainty and human variability in toxicokinetics and dose-response while at the US Environmental Protection Agency (EPA), where he worked for over 14 years, most recently as Chief of the Toxicity Pathways Branch in the Integrated Risk Information System (IRIS) Division of the National Center for Environmental Assessment. He led the development of US EPA’s 2011 IRIS assessment of trichloroethylene. Dr. Chiu also was a member of a World Health Organization/International Programme on Chemical Safety (WHO/IPCS) workgroup on uncertainty and variability and is a lead author of the 2014 WHO/IPCS Guidance Document on Evaluating and Expressing Uncertainty in Hazard Characterization that develops a harmonized approach to assessing cancer and non-cancer risks from chemical exposures. Now in the Department of Veterinary Integrative Biosciences in the College of Veterinary Medicine and Biomedical Sciences at Texas A&M University, his current research interests include the use of probabilistic approaches and emerging in vitro and in vivo data streams to characterize dose-response and interindividual variations in susceptibility.
The Use of the Mechanistic Evidence in Human Health Assessments
J. Vincent Cogliano (by webinar), US Environmental Protection Agency, Crystal City, Virginia
Dr. Cogliano is interested in qualitative and quantitative health risk assessment and its application to the protection of public health. He serves as director of the Integrated Risk Information System (IRIS) at the US Environmental Protection Agency in Washington, DC. IRIS develops scientific reviews of the health hazards of chemicals in the environment. Previously, Dr Cogliano served as head of the International Agency for Research on Cancer (IARC) Monographs Programme (IARIC is part of the World Health Organization) in Lyon, France. The IARC Monographs are a series of scientific reviews that identify environmental factors that can increase the risk of human cancer.
The recordings, slides, and captioning are available for the previous events at the Colloquia website.