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April 25, 2013 Kathleen Sebelius Secretary, Health and Human

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April 25, 2013 Kathleen Sebelius Secretary, Health and Human April 25, 2013 Kathleen Sebelius Secretary, Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 [email protected] Cc: Bob Perciasepe Acting Administrator, US Environmental Protection Agency Ariel Rios Building, 4101 M 1200 Pennsylvania Avenue, N.W. Washington, DC 20460 [email protected] Dr. Margaret A. Hamburg Commissioner, U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 [email protected] Dear Secretary Sebelius: We, the undersigned, represent a wide range of research scientists, public-interest and consumer organizations with an interest in the federal government’s advice regarding fish consumption, methylmercury in seafood, and health. The current US advisory on this topic, issued by EPA and FDA in March 2004, was developed in 2003, based on studies published in the 1990s, and is now out of date and insufficiently protective of public health. Research carried out in the past decade has both clarified the beneficial nutritional effects of fish consumption during pregnancy and found adverse effects of prenatal methylmercury exposure at very low doses, at least an order of magnitude below exposures known to be harmful when the current Advisory was written. Consumers, the public health community, state health officials and others who advise the public on the benefits and risks of seafood consumption therefore urgently need an up-to-date federal statement on this topic. In 2009, FDA began a process to update the 2004 Advisory by publishing a draft assessment of benefits and risks of fish consumption for public comment. That draft was criticized by many commenters (including some signers of this letter) for a variety of scientific weaknesses. The FDA, in collaboration with the EPA, then undertook to revise the benefit/risk assessment in response to the comments. The clear expectation, stated openly by FDA officials, was that a draft of the proposed updated Advisory and the supporting benefit/risk assessment would be published in the Federal Register for public comment sometime in 2012. Our understanding is that the draft was signed off on by FDA and EPA last fall as finished and ready for publication, but approval to publish it has stalled within HHS. The public comment process, of course, allows stakeholders, other government agencies and ordinary citizens to address perceived needs for improvements in the draft. We want an opportunity to provide input on this matter and would like to do so sooner, rather than later. We therefore urge you to expedite publication of the benefit/risk assessment and the updated Advisory so that the process of upgrading the government’s fish consumption advice can move forward, as it must. Please resolve any internal problems promptly and publish these documents for public comment. Sincerely,i Edward Groth III, PhDii Groth Consulting Services 75 Clifford Avenue, Pelham, NY 10803 David Bellinger, PhD Professor of Environmental Health Harvard School of Public Health Michael Bender, MS Executive Director Mercury Policy Project John Blair, president Valley Watch, Inc. Evansville, IN Leslie I. Boden, PhD Department of Environmental Health Boston University School of Public Health Joanna Burger, PhD Distinguished Professor of Biology Rutgers University Anna L Choi, ScD School of Public Health Harvard University Tyson Cook, MS, Staff Scientist Amber Meyer Smith, Director of Programs and Government Relations Clean Wisconsin Adam Finkel, ScD, CIH Senior Fellow and Executive Director, Penn Program on Regulation University of Pennsylvania Law School, And Professor of Environmental and Occupational Health School of Public Health University of Medicine and Dentistry of New Jersey Timothy Fitzgerald, MSc Marine Scientist Environmental Defense Fund Steven G. Gilbert, PhD, DABT Executive Director Institute of Neurotoxicology & Neurological Disorders, Seattle Michael Gochfeld, MD, PhD Environmental & Occupational Health Sciences Institute Robert Wood Johnson Medical School Philippe Grandjean, MD Adjunct Professor of Environmental Health Harvard School of Public Health Karen Hadden Executive Director Sustainable Energy and Economic Development Coalition San Antonio Dale B. Hattis, PhD The George Perkins Marsh Institute Clark University Jane M. Hightower, MD California Pacific Medical Center San Francisco Susan Keane, MS Deputy Director, Health and Environment Natural Resources Defense Council Donald Kennedy, PhD President Emeritus Stanford University Lynda Knobeloch, PhD Toxicology and Public Health Consultant Mount Dora, FL Barry Kohl, Ph.D. President Louisiana Audubon Council Amy D. Kyle, PhD, MPH School of Public Health University of California, Berkeley Bruce P. Lanphear, MD, MPH Child & Family Research Institute Simon Fraser University Lisa Y. Lefferts, MSPH, Senior Scientist Caroline Smith DeWaal, Food Safety Director Center for Science in the Public Interest Sherri Norris Executive Director California Indian Environmental Alliance, Oakland Urvashi Rangan, PhD Director, Consumer Safety and Sustainability Consumers Union of United States, Inc. Carl Safina, PhD President Blue Ocean Institute And Professor, School of Marine and Atmospheric Sciences and Center for Communicating Science, School of Journalism Stony Brook University Ted Schettler, MD, MPH Science Director Science and Environmental Health Network Robin Schneider Executive Director Texas Campaign for the Environment Renee Sharp Director of Research Environmental Working Group Ellen K. Silbergeld, PhD Professor, Environmental Health Sciences Johns Hopkins Bloomberg School of Public Health Susan Silbernagel, MPA Gelfond Fund for Mercury Research & Outreach Stony Brook University Ted Smith, Coordinator International Campaign for Responsible Technology San Jose, CA Tom “Smitty” Smith Director, Texas Office, Public Citizen San Antonio Todd Steiner Executive Director GotMercury.org/Turtle Island Restoration Network Eric Uram Executive Director, Safe Minds Madison. WI David Wallinga, MD Kathleen Schuler, MPH Institute for Agriculture & Trade Policy Minneapolis Robert Wendelgass, President & CEO Clean Water Action Charles Winterwood, MD Chair, National Toxics Committee Sierra Club i Institutional affiliations are provided for purposes of identification only and do not imply endorsement of the views expressed in this letter by anyone other than the individual signers. ii Lead author, to whom correspondence should be sent. .
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