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Arsenic in Rice and Rice Products Risk Assessment Report

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Arsenic in Rice and Rice Products Risk Assessment Report Arsenic in Rice and Rice Products Risk Assessment Report Center for Food Safety and Applied Nutrition Food and Drug Administration U.S. Department of Health and Human Services March 2016 Version Released for Public Comment CONTRIBUTORS Project Co-Leads: Sherri Dennis, PhD Suzanne Fitzpatrick, PhD, DABT Project Manager: Dana Hoffman-Pennesi, MS Risk Modelers: Clark Carrington, PhD, DABT (Retired April 2015) Régis Pouillot, DVM, PhD Subject Matter Experts: Katie Egan (Retired July 2013) Brenna Flannery, PhD Richard Kanwal, MD Deborah Smegal, MPH Judi Spungen, MS Shirley Tao, PhD Technical Writer/Editor: Susan Mary Cahill CITATION FOR THIS REPORT: U.S. Food and Drug Administration. 2016. Arsenic in Rice and Rice Products Risk Assessment Report. Available at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm. Arsenic in Rice and Rice Products Risk Assessment Report Progress: Risk Management Team Review: Draft Risk Assessment Report dated November 2013 Interagency Expert Review: Draft Risk Assessment Report dated December 2013 CFSAN/FDA Review/Clearance – Draft Risk Assessment Report dated February 2014 HHS Clearance – Draft Risk Assessment Report dated May 2014 OMB Review: Draft Risk Assessment Report dated May 2014 (revised April 2015) and Addendum to the May 2014 Risk Assessment Report (draft dated May 2015) External Peer Review: Draft Risk Assessment Report dated July 2015 and Addendum dated May 2015 Revised Report based on External Peer Review and Incorporation of Addendum: Risk Assessment Report dated October 2015 Revised Report based on additional comments from OMB: Risk Assessment Report dated December 2015 May 13, 2014 Arsenic in Rice and Rice Products Risk Assessment Report (Revised March 2016) | i ACKNOWLEDGMENTS The FDA Arsenic in Rice and Rice Products Risk Assessment benefited from contributions, conversations, and information provided by many individuals, organizations, and government officials. We thank and acknowledge, in particular, the following: • Risk Management/Advisor Team (FDA-CFSAN): Don Zink, PhD (lead); Susan M. Bernard, JD, DrPH; Nega Beru, PhD; Anne Crawford (Project Manager); Michael M. Landa, JD (Retired January 2015); Susan Mayne, PhD; Stephen Ostroff, MD; Linda Tollefson, DVM, MS (Retired March 2014); David G. White, PhD. • Risk Communication Team (FDA-CFSAN): Sharon Natanblut (lead); Noah Bartolucci; Steven Bradbard, PhD; Sharmi Das; Theresa Eisenman; Suzanne Fitzpatrick, PhD, DABT; Douglas Karas; Susan Kelly; Ji Sun Lee; Jordan Lin, PhD; Stephen Ostroff, MD; Benson M. Silverman, MD (Deceased). • Greg Noonan (FDA-CFSAN); Greg Diachenko (FDA-CFSAN); Philip Spiller (FDA- CFSAN; Retired January 2015), Bill Mindak (FDA-CFSAN), Sean Conklin (FDA-CFSAN), and Patrick Gray (FDA-CFSAN) and the laboratories that assisted in the analysis of FDA’s rice and rice products samples and related research • Mark Wirtz (FDA-CFSAN) and Stephanie Briguglio, MPH, CPH (FDA-CFSAN), for providing Total Diet Study data • Stuart Chirtel(FDA-CFSAN) for statistical support in data analysis • Lori Papadakis (FDA-CFSAN) for coordinating and managing peer review • Andy Meharg, Queen’s University Belfast, Belfast, United Kingdom • National Center for Toxicological Research (NCTR) • U.S. Environmental Protection Agency (EPA) • National Institute of Environmental Health Science (NIEHS) • U.S. Department of Agriculture – Agricultural Research Service (USDA-ARS) • Nathan Childs, U.S. Department of Agriculture – Economic Research Service (USDA-ERS) • Oak Ridge National Laboratories, for providing literature searches and literature analysis under contract • Vicki Freimuth, PhD (Center for Health and Risk Communication and Professor, Department of Speech Communication and Grady College of Journalism and Mass Communication) for assistance with risk communication We thank the experts who participated in a federal interagency peer review of an earlier draft of this risk assessment, including: • Peter Lurie, MD (FDA-OC) • Thomas J. Flammang, PhD; Dan Doerge, PhD; James Chen, PhD; Deborah Hansen, PhD, U.S. Food and Drug Administration – National Center for Toxicological Research (FDA- NCTR) May 13, 2014 Arsenic in Rice and Rice Products Risk Assessment Report (Revised March 2016)| ii Acknowledgements | • Reeder L. Sams II, PhD; John Cowden, PhD; Jeff Gift, PhD; Allen Davis, PhD; David Thomas, PhD; Janice Lee, PhD; Karen Bradham, PhD; Linda Phillips, PhD; Lyle Burgoon, PhD; John Vandenburg, PhD; Kan Shao, PhD; Ellen Kirrane, PhD; Bob Hetes, PhD, U.S. Environmental Protection Agency – Office of Research and Development (EPA-ORD) • Santhini Ramasamy, PhD, MPH, DABT, U.S. EPA, Office of Water, Office of Science and Technology (EPA-OW-OST) • Linda S. Birnbaum, PhD, DABT, ATS , Michael Waalkes, PhD, and Danielle Carlin, PhD, DABT, National Institutes of Health, National Institute of Environmental Health Sciences (NIH-NIEHS) • (NIH-NIEHS) • Barbara A. Ellis, PhD, Agency for Toxic Substances and Disease Registry - National Center for Environmental Health (ATSDR-NCEH) and seven anonymous reviewers We thank Versar, Inc. and the experts who participated in the external peer review of this risk assessment, including: • David Bottimore, Versar, Inc. • Tracy Lang, Versar, Inc. • John Rella, Versar, Inc. • Aaron Barchowsky, PhD, University of Pittsburgh Dept of Environmental and Occupational Health • Rebecca Fry, PhD, University of North Carolina Gillings School of Global Public Health • Barry P. Rosen, PhD, Florida International University Herbert Werthiem College of Medicine dept of Cellular Biology and Pharmacology • Craig M. Steinmaus, MD, MPH, UC Berkeley School of Public Health • Marie Vahter, Karolinska Institutet Institute of Environmental Medicine May 13, 2014 Arsenic in Rice and Rice Products Risk Assessment Report (Revised March 2016) | iii TABLE OF CONTENTS Contributors.................................................................................................................................................................... i Acknowledgments ......................................................................................................................................................... ii Table of Contents ......................................................................................................................................................... iv List of Tables ................................................................................................................................................................ vii List of Figures ................................................................................................................................................................. x Abbreviations and Acronyms ...................................................................................................................................... xiii Executive Summary ....................................................................................................................................................... 1 1 Introduction ............................................................................................................................................................. 7 1.1 Process for Conducting Risk Assessments ................................................................................................... 8 1.2 Objectives and Scope of the Risk Assessment ............................................................................................. 9 1.3 Collaborations ............................................................................................................................................ 12 2 Hazard Identification.............................................................................................................................................. 13 2.1 The Contaminant: Arsenic ......................................................................................................................... 13 2.1.1 Introduction ............................................................................................................................... 13 2.1.2 Absorption, Distribution, Metabolism, and Excretion................................................................ 14 2.2 Health Effects of Inorganic Arsenic ............................................................................................................ 16 2.2.1 Proposed Mechanisms of Action ................................................................................................ 16 2.2.2 Short-Term and Intermediate Exposure..................................................................................... 18 2.2.3 Chronic Exposure........................................................................................................................ 18 2.2.4 Epidemiological Studies.............................................................................................................. 19 2.3 Health Effects of MMA and DMA .............................................................................................................. 20 2.3.1 Toxicity of Organic Species ......................................................................................................... 20 2.4 Effects of Early-Life Exposure to Arsenic ................................................................................................... 21 2.5 Lung and Bladder Cancer: Background Incidence, Lifetime Risk, and Risk Factors in the U.S. .................. 22 2.6 Non-Cancer
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