Advances in Health-Based Decision Making

The Evolution and Continuing Importance of Risk-Based Decisions and the Increasing Influence of Hazard-Based Approaches

Joseph Rodricks, PhD, Founding Principal, Ramboll-Environ, Arlington, VA, USA

Uncontrolled exposures to many chemical, biological, and physical agents present in foods and other consumer products, the general environment, and the workplace can threaten human health in diverse ways.  Decisions to protect populations, whether in regulatory or other contexts, depend upon an adequate understanding of the health risks these agents pose, and on the means available to manage those risks.  Significant progress in risk assessment and the sciences upon which its conduct depends, and in risk management practices, has been seen since their formal introduction in the 1980s, and will be reviewed, together with practices related to uncertainty analysis and risk communication.  Risk-based decision models, particularly those related to the many different types of challenges associated with food, will be elaborated.  Thus, nutrients, other natural constituents of food, the various types of intentionally introduced substances, and the several categories of food contaminants and process-formed chemicals, each requires its own type of risk management approach and risk assessments that are useful for those approaches.  Moreover, nutrients and other food substances may, under certain conditions of exposure, reduce risks of certain diseases, and risk-based decision models will be used to illustrate how such health benefits can be taken into account.  Finally, the long-standing tensions between those who advocate risk-based decisions and those who advocate much simpler hazard-based decisions (those based solely on the type of harm an agent can cause, and not on the probability that the harm will occur) will be explained, as will the forces at work to increase dependence on hazard-based approaches.  The difficulties associated with hazard-based decisions will be elaborated, as will the improvements needed to increase confidence in risk-based decision making.

How Evolving Science is Improving Safety Assessment of Food Relevant Chemicals

Andrew Maier, PhD, Director Risk Science Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA

Techniques and methods continue to improve for assessing the potential toxicity of chemicals and for assessing safety for diverse exposure scenarios. Assessments of food relevant chemicals are no exception to this progress. The availability of enhanced methods reflects improvements in biological understanding of toxicity coupled with increased access to mathematical and statistical tools. This presentation highlights how developments in safety assessment tools are increasing confidence in assessments, better communicating uncertainty and data gaps, and supporting more robust risk-informed decisions. Traditional safety assessments based on the safe dose concept are making greater use of data. There are many examples to highlight this shift, for example: 1) ongoing movement from study dose determined risk assessment starting points such as no observed adverse effect levels with dose-response modeled alternatives such as benchmark doses, 2) use of data derived extrapolations to replace default uncertainty factors, 3) and taking advantage of predictive tools to fill data gaps. Since these tools maximize the use of data, they can increase the scientific rigor of an assessment. But they can also increase complexity. Thus, care is needed to clearly communicate the concepts of uncertainty, variability, and accuracy. To support confidence in the basis of these advanced safety assessments, increased attention is also being given to transparency in weighing evidence using systematic approaches as well as documenting uncertainties. The integrated use of all these methods developments will be highlighted for food relevant assessment scenarios and case studies. The field of safety assessment is not stagnant. Ongoing effort reflects the goal of ensuring effective use of advances in best practices to better inform decision-making for public health.

Evidence-Based Evaluation of Benefits from Food Components

David M. Klurfeld, USDA Agricultural Research Service, Beltsville, MD, USA

Most scientists are familiar with some version of a pyramid showing hierarchies of evidence, with expert opinion at the bottom and systematic reviews at the top. Systematic reviews are of varying quality, therefore not all are unimpeachable sources for conclusions while most scientific committee recommendations are simply expert opinions. Some reasons for this are a lack of evidence for many nutrition issues; there is plenty of weak evidence, and there are gaps in evidence. These weaknesses stem, in part, from uncertainty factors, some of which are due to subpopulation variability which, in turn, may be due to genetic polymorphisms, epigenetic changes in gene expression, and difference in individual’s microbiomes. Translating evidence to recommendations often has to deal with what constitutes sufficient science to make a recommendation. Objective grading systems exist for dealing with many of these problems such as GRADE (Grading of Recommendations Assessment, Development and Evaluation) but the nutrition field has not yet adopted this approach to any extent. The recent National Academies report on Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease recommended use of this system in future DRI reviews. Most other public health nutrition recommendations have yet to realize the importance of weighing evidence. Uncertainty factors point to a new paradigm of precision nutrition that is being created through use of various omics analyses and will, at some future time, replace the existing public health approach of a single solution for nutritional recommendations. All of this should result in better assessment of the net benefit in nutrition decisions.

Deirdra N. Chester, PhD, RDN

Deirdra Chester is the Acting Division Director in the Division of Nutrition, Institute of Food Safety and Nutrition at the National Institute of Food and Agriculture, USDA.  Prior to joining NIFA, Dr. Chester was a scientist at the USDA- Agriculture Research Service.  In her role as the National Program Leader of Applied Nutrition Research, she provided leadership in identifying emerging issues of national importance, program reviews, and grants management in the area of nutrition, functional components of food, and childhood obesity.  She also provides leadership for the Agriculture and Food Research Initiative (AFRI) Childhood Obesity Prevention and the Foundational Program - Function of Efficacy and Nutrient competitive grants programs.  She provides co-leadership for a joint USDA - NIH competitive grants program.  She has worked extensively with a number of inter and intra-agency projects and programs with the FDA, NIH and the CDC including Let’s Move, the National Collaborative on Childhood Obesity Research (NCCOR), the Interagency Committee on Dietary Guidance Committee (ICHNR), the USDA Human Nutrition Coordinating Committee, the Joint Dietary Guidance Review Committee, and the NIH Nutrition Coordinating Committee.  Participation on these committees resulted in the development of the National Nutrition Roadmap and the Dietary Guidelines.

Dr. Chester serves on the Executive Board and is a Past-Chair of the Food and Nutrition Section of the American Public Health Association. She was recently awarded the Mary C. Egan Award which recognizes pioneers in innovative approaches to public health nutrition. She is a Past-Chair of the Research Committee and a past member of the Committee on Professional Development of the Academy of Nutrition and Dietetics.  She is a past member of the Dietetics Based Practice Research Network Committee. Dr. Chester is a Registered Dietitian/Nutritionist.

She currently holds membership in the following professional organizations: The Academy of Nutrition and Dietetics, the American Public Health Association and the Institute of Food Technologist. Dr. Chester has spoken both nationally and internationally on nutrition topics. Dr. Chester is on the editorial board of the Journal of Obesity and Chronic Disease.

Dr. Chester and holds a Doctor of Philosophy degree in Nutrition from Florida International University where she was awarded the McKnight Doctoral Fellowship and was in the inaugural class of the Gates Millennial Scholars. She holds a Master of Science degree in Food and Nutrition Science and a baccalaureate degree in Nutrition and Dietetics from Florida State University. 

Stephen James Crozier, PhD

Stephen Crozier began working at The Hershey Company in 2011.  In his current role within Global Research & Development he is responsible for managing clinical research projects and facilitating process and ingredient innovation. Prior to joining The Hershey Company, Stephen was an adjunct professor in the Department of Cellular & Molecular Physiology at Penn State College of Medicine and a post-doctoral fellow studying the relationship between nutrition and gastrointestinal function in the Department of Physiology at the University of Michigan.

Dr. Crozier is a member of the American Physiological Society and the American Society for Nutrition and serves as a reviewer for several journals.  He is the current chair of the ILSI North America Balancing Food & Activity for Health Committee and is The Hershey Company’s representative on the ILSI North America Carbohydrates and ILSI North America Protein Committees. 

Dr. Crozier attained a BSc in Biochemistry from Mount Allison University in Canada, an MSc in Medical Genetics from the University of Aberdeen in Scotland, and a PhD in Physiology from Penn State College of Medicine.  He currently resides in Hummelstown, PA with his wife Nicole and their three daughters. 

John L. Sievenpiper, MD, PhD, FRCPC

Dr. Sievenpiper is an Associate Professor in the Department of Nutritional Sciences and the Lifestyle Medicine Lead in the MD Program, Faculty of Medicine, University of Toronto. He also holds appointments as a Staff Physician in the Division of Endocrinology & Metabolism and Scientist in the La Ka Shing Knowledge Institute, St. Michael’s Hospital. Dr. Sievenpiper completed his MSc, PhD and Postdoctoral Fellowship training in the Department of Nutritional Sciences, Faculty of Medicine, University of Toronto. He completed his MD at St. Matthew’s University followed by Residency training in Medical Biochemistry at McMaster University leading to his certification as a Fellow of the Royal College of Physicians of Canada (FRCPC). His research is focused on using randomized controlled trials and systematic reviews and meta-analyses to address questions of clinical and public health importance in relation to diet and chronic disease prevention. He currently holds a PSI Foundation Graham Farquharson Knowledge Translation Fellowship, Canadian Diabetes Association Clinician Scientist Award, and Banting & Best Diabetes Centre Sun Life Financial New Investigator Award. He has authored more than 140 scientific papers and 13 book chapters. Dr. Sievenpiper is directly involved in knowledge translation with appointments to the nutrition guidelines’ committees of the Canadian Diabetes Association (CDA), European Association for the study of Diabetes (EASD), and Canadian Cardiovascular Society (CCS).

Patricia Williamson, PhD

Patricia Williamson is currently a Principal Scientist in Scientific and Regulatory Affairs for Cargill.  Previously, Dr. Williamson served as a Senior Nutrition Scientist at Tate & Lyle and Nutrition Scientist for ADM. During her time in the food ingredient industry, Dr. Williamson has supported health and wellness ingredients including soluble fibers, proteins, bioactives, and sweeteners. Dr. Williamson’s core responsibilities have included the review and conduct of basic scientific research, pre-clinical research, and human clinical research for the past 17 years.  She has been responsible for formulating research strategies and collaborations to push innovations and support the beneficial effects of food ingredients. Dr. Williamson carries a practical working understanding of food and agriculture from the vantage point of commodity food ingredient processing and specialty food ingredients. 

She has served on several professional committees including being a member of the ILSI North America Carbohydrates Committee where she currently serves as the Fiber Subcommittee Chair. Dr. Williamson’s background in nutritional biochemistry, gastrointestinal health, metabolism, appetite regulation, and endocrinology are reflected in her professional publication history.  She also has interests in food & nutrition regulation and policy.  Dr. Williamson received a bachelor's degree from Central Methodist University in Biology, and both a master's and doctor of philosophy degrees in Nutrition Sciences from the University of Missouri – Columbia with emphasis in biochemistry and endocrinology respectively. Her post-doctoral work was completed at the Oregon National Primate Research Center in neuroendocrine regulation of appetite and reproductive physiology.

Joseph Rodricks, PhD

Dr. Joseph Rodricks is a founding Principal of ENVIRON, and is now a Principal of Ramboll Environ. He is an internationally recognized expert in toxicology and risk analysis. He has consulted for hundreds of manufacturers, government agencies and for the World Health Organization in the evaluation of health risks associated with human exposure to chemical substances of all types. Dr. Rodricks came to consulting after a 15-year career as a scientist at the US Food and Drug Administration (USFDA). In his last four years at the USFDA, he served as Associate Commissioner for Health Affairs. His experience extends from pharmaceuticals, medical devices, consumer products and foods, to occupational chemicals and environmental contaminants. He has served on the National Research Council’s Board on Environmental Studies and Toxicology, and on more than 30 boards and committees of the National Academy of Sciences and the Institute of Medicine, including the committees that produced the seminal works Risk Assessment in the Federal Government: Managing the Process (1983), and Science and Decisions–Advancing Risk Assessment (2009). He has more than 150 scientific publications and has received honorary awards from three professional societies for his contributions to toxicology and risk analysis. He is author of the widely-used text, Calculated Risks, now in its second edition, published by Cambridge University Press, and has presented more than 500 lectures in countries around the world. Dr. Rodricks has been certified as a Diplomate of the American Board of Toxicology since 1981.

Andrew Maier, PhD, CIH, DABT

Andrew Maier is an associate professor of environmental and industrial hygiene at the University of Cincinnati (UC) College of Medicine. He also serves as the Director of the UC Risk Science Center housed within the Department of Environmental Health. His research focuses on methods for integrating mechanistic toxicology and exposure information to improve the development of health-based chemical exposure limits. Andrew has served on numerous expert committees, including current service as a science advisor for the Food and Chemical Safety Committee of ILSI North America. He is the Editor in Chief of the International Journal of Occupational and Environmental Health, and Past President of the Society of Toxicology Occupational and Public Health Specialty Section. He earned a PhD, in molecular toxicology from the University of Cincinnati and a M.S. in industrial health from the University of Michigan.

David M. Klurfeld, PhD

David Klurfeld has been National Program Leader for Human Nutrition in the Agricultural Research Service of the U.S. Department of Agriculture since 2004.  He is responsible for the scientific direction of the intramural human nutrition research conducted by USDA laboratories.  Prior to government service, he was Professor and Chairman of the Department of Nutrition & Food Science at Wayne State University in Detroit, Michigan for 12 years.  Before that he was on the faculty of The Wistar Institute and the University of Pennsylvania School of Medicine for 15 years.

Dr. Klurfeld’s research focuses on the relationship of diet and prevention of chronic diseases such as cancer, heart disease, and gallstones.  Among his scientific discoveries are the first demonstration that red wine consumption resulted in fewer cardiovascular lesions, that the cholesterol-filled cells in human arterial lesions are white blood cells, that reducing calories was more important than reducing fat in the diet for decreasing cancer growth, and a mediator of this last effect was likely IGF-1. Dr. Klurfeld has published more than 195 peer-reviewed articles and book chapters.  He has been Associate Editor of the American Journal for Clinical Nutrition for 10 years and is also a member of National Institute for Diabetes, Digestive and Kidney Diseases Advisory Council. Dr. Klurfeld received his undergraduate degree from Cornell University and both master’s and doctorate degrees in pathology from the Medical College of Virginia.