DOCSLIB.ORG

Research Report 26, Including the Report of the HEI Review Committee

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Research Report 26, Including the Report of the HEI Review Committee Investigation of a Potential Cotumorigenic Effect of the Dioxides of Nitrogen and Sulfur, and of Diesel-Engine Exhaust, on the Respiratory Tract of Syrian Golden Hamsters Uwe Heinrich, Ulrich Mohr, Rainer Fuhst, and Carsten Brockmeyer FraunhoJer Institute for Toxicology and Aerosol Research, Hannover, Federal Republic of Germany Includes the Report of the Institute's Health Review Committee Research Report Number 26 The Health Effects Institute (HEI) is a nonprofit corporation founded in 1980 to assure that objective, credible, high-quality scientific studies are conducted on the potential human health effects of motor vehicle emissions. Funded equally by the U.S. Environmental Protection Agency (EPA) and 27 automotive manufacturers or marketers in the United States, HEI is independently governed. Its research projects are selected, conducted, and evaluated according to a careful public process, including a rigorous peer review process, to assure both credibility and high scientific standards. HEI makes no recommen­ dations on regulatory and social policy. Its goal, as stated by former EPA Administrator William D. Ruckelshaus, is "simply to gain acceptance by all parties of the data that may be necessary for future regulations." The Board of Directors Archibald Cox Chairman Donald Kennedy Carl M. Loeb University Professor (Emeritus), Harvard Law School President, Stanford University Charles W. Powers William 0. Baker Partner, Resources for Responsible Management; Founding Executive Chairman (Emeritus), Bell Laboratories Director, HE! Health Research Committee Walter A. Rosenblith Chairman Robert F. Sawyer Institute Professor (Emeritus), Massachusetts Institute of 1cchnology Professor of Mechanical Engineering, University of California, Berkeley Joseph D. Brain John W. Tukey Cecil K. and Philip Drinker Professor of Environmental Physiology, Senior Research Statistician; and Donner Professor of Science Emeritus, Harvard University School of Public Health Princeton University Mark Utell Curtis C. Harris J. Professor of Medicine and Toxicology, University of Rochester School of Chief, Laboratory of Human Carcinogenesis, National Cancer Institute Medicine Barbara Hulka Gerald N. Wogan Chairperson, Department of Epidemiology, University of North Carolina Professor of Toxicology, Massachusetts Institute of 'lochnology Roger 0. McClellan Werner Stoeber Special Consultant to the Committee President, Chemical Industry Institute of Toxicology Director, Fraunhofor Institute of Toxicology and Aerosol Research Health Review Committee Arthur Upton Chairman Paul Meier Professor and Chairman, Inotitute of Environmental Medicine, New York Professor of Statistics, University of Chicago University Sheldon D. Murphy Bernard Goldstein Chairman, Department of Environmental lfealth, University of Professor and Chairn1an, Dcpartn1ent of Environmental and Cmnmunity Washington Medicine, University of Medicine and Dentistry of New jersey, Robert Herbert Rosenkranz Wood johnson Medical Center Mary Ann Swetland Professor and Chairman, Department of Gareth M. Green Enviromnental Health Sciences, Case \'\'estern Reserve University Professor and Chairman, Department of Environmental Science, johno James Grizzle Special Consultant to the Committee Hopkins University Associate Director of Cancer Prevention Research Program, Millicient W. P. Higgins Fred Hutchinson Cancer Research Center Associate Director for Epidemiology and Biometry, National Heart. Lung and Blood Institute Officers and Staff Andrew Sivak Executive Director Brenda E. Barry Staff Scientist Richard M. Cooper Corporate Sccretmy Ann Y. Watson Consulting Staff Scientist L. Virgi Hepner Publications Manager Rashid Shaikh Director for Scientific Reviel\' and Evaluation Mary-Ellen Patten Administrative Assistant Jane Warren Director of Research Gail Allosso Assistant to the Director of Administration and Finance Judith Zalon Director of Administration and Finance Hannah Protzman Secretary Debra N. Johnson Controller Janet Fader Secretary Kathleen Nauss Senior Staff Scientist Wendy Charest Secretary Maria Costantini Staff Scientist Patricia White Receptionist Alison M. Dorries Staff Scientist Robin A. Cuozzo Accounting Assistant Research Agreement No. 83-26 Copyright © 1989 by Health Effects Institute Printed at Capital City Press, Montpelier, VT TABLE OF CONTENTS Research Report No. 26 Investigation of a Potential Cotumorigenic Effect ofthe Dioxides of Nitrogen and Sulfur, and of Diesel~Engine Exhaust, on the Respiratory Tract of Syrian Golden Hamsters INVESTIG!:..TOR..<i' REPORT Uwe Heinrich, Ulrich Mohr, Rainer Fuhst, and Carsten Brockmeyer Abstract . 1 Larynx and Trachea . 7 Introduction . 1 Lungs ................................. 13 Aiins............ 2 Histopathological Findings in the Respiratory Tract Materials and Methods . 2 of Animals Not Assigned to Serial Sacrifice .... 14 Animals and Housing Conditions . 2 Nasal Cavity ............................ 14 Diesel-Exhaust Exposure . 3 Larynx, Trachea, and Major Bronchi ........ 14 Exposure to a Nitrogen Dioxide/Sulfur Dioxide Lungs ................................. 15 Mixture.................................. 3 Tumors in the Respiratory Tract ................ 15 Diethylnitrosamine Treatment. 5 Discussion . 17 Histopathology . 5 Conclusions ................................... 20 Statistical Analysis . 6 Acknowledgments .............................. 22 Results . 6 References .................................... 22 Health Status of the Animals . 6 Appendix A. Cumulative Proportion of Surviving Survival Time . 6 Animals and Animals Dying Without a Respiratory Tract Tumor ...................... 24 Histopathological and Scanning Electron Microscopy Findings in the Respiratory Tract About the Authors .............................. 27 Abbreviations After Various Exposures to N02/S02 Gas or .................................. 27 Diesel Exhaust . 6 HEALTH REVIEW COMMITTEE'S REPORT Health Effects Institute Introduction ................................... 29 Attainment of Study Objectives ................. 32 The Clean Air Act .............................. 29 Methods and Study Design .................... 32 Background ................................... 29 Results and Interpretation ..................... 32 Justification for the Study ........................ 31 Remaining Uncertainties and Implications for Objectives of the Study. 31 Future Research . 33 Study Design .................................. 31 Conclusions ................................... 33 Technical Evaluation ............................ 32 References . 33 j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j J INVESTIGATORS' REPORT Investiga~ion of a .Potential Cotumorigenk Effect of the Dioxides of Nitrogen and Sulfur, and of D1esel~Engme Exhaust, on the Respiratory Tract of Syrian Golden Hamsters Uwe Heinrich, Ulrich Mohr, Rainer Fuhst, and Carsten Brockmeyer1 ABSTRACT oxidants, and polycyclic aromatic hydrocarbons (PAHs), are actually common to all kinds of combustion-engine ex­ haust. In addition to these traces, however, Syrian golden hamsters (480 males and 480 females) allo­ diesel engines characteristically produce and discharge carbonaceous cated into 24 groups were exposed 19 hours per day and 5 particles and, to a small extent depending days per week for 6, 10.5, 15, or 18 months to total diesel ex­ on the quality of the fuel, sulfur dioxide ). haust, diesel exhaust without particles, a mixture of nitro­ (S02 Some of the less volatile PAHs are known carcinogens and adsorb easily, along with gen dioxide (5 parts per million [ppm] 2) and sulfur dioxide other vaporized organics of low volatility, (10 ppm), or clean air. Two exposure groups from each test on the surface of the diesel soot particles. There are suggestions atmosphere were also treated by a single subcutaneous in­ from trends in epidemiologic investigations (Howe eta!. 1983) jection of either 3 mg or 6 mg of diethylnitrosamine/kg of and indi­ cations from laboratory body weight to evaluate an enhancing effect of diethyl­ experiments (Heinrich eta!. 1982, 1986; Brightwell eta!. 1986; nitrosamine on exposure-related changes. Morphological Ishinishi eta!. 1986; Iwai eta!. 1986; Mauderly et a!. 1986) that exposure evaluation was done by histopathology. Minor changes of to diesel soot might increase the risk of lung cancer the larynx and trachea were investigated by scanning elec­ in humans. Recently, long-term inhalation studies on rats have tron microscopy, which showed a loss of ciliated cells in all shown that diesel­ engine exhaust, if exhaust-exposed groups. After exposure to diesel exhaust inhaled in sufficiently high concentra­ tions, induces lung tumors (bronchioloalveolar adenomas, with or without particles, focal metaplasia and dysplasia of adenocarcinomas, and squamous the respiratory epithelium were seen in the oldest animals cell tumors) in rats, but not in hamsters (Brightwell et 1986; by scanning electron microscopy. In the same specimens, a!. Heinrich et a!. 1986). attached mucous droplets indicated changes in mucous cells and mucous viscosity. These hamster results confirmed findings of an earlier long-term inhalation study (Heinrich eta!. 1982) in which Only the exposure to total diesel exhaust significantly in­ we did not observe any carcinogenic effects of diesel creased the tumor rate in the upper respiratory tract of male ex­ haust in Syrian golden hamsters; only female Syrian hamsters treated with 6 mg of diethylnitrosamine per kg of golden hamsters were
Load more

Recommended publications
  • Overruling the Food and Drug Administration
    Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Alisha Crovetto, Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action (May 2012). Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:10985168 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action Alisha Crovetto Harvard Law School J.D. Candidate, 2013 May 2012 Food & Drug Law Course Paper Abstract On December 7, 2011, newspaper headlines from coast to coast announced that Plan B One-Step, a form of emergency contraception, would not be made available to females under seventeen without a prescription. The denial of over-the-counter (“OTC”) status, though newsworthy itself, drew particular attention because of the unusual nature of the decision. As the New York Times announced, “[f]or the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration .
    [Show full text]
  • Masakazu Konishi
    Masakazu Konishi BORN: Kyoto, Japan February 17, 1933 EDUCATION: Hokkaido University, Sapporo, Japan, B.S. (1956) Hokkaido University, Sapporo, Japan, M.S. (1958) University of California, Berkeley, Ph.D. (1963) APPOINTMENTS: Postdoctoral Fellow, University of Tübingen, Germany (1963–1964) Postdoctoral Fellow, Division of Experimental Neurophysiology, Max-Planck Institut, Munich, Germany (1964–1965) Assistant Professor of Biology, University of Wisconsin, Madison (1965–1966) Assistant Professor of Biology, Princeton University (1966–1970) Associate Professor of Biology, Princeton University (1970–1975) Professor of Biology, California Institute of Technology (1975– 1980) Bing Professor of Behavioral Biology, California Institute of Technology (1980– ) HONORS AND AWARDS (SELECTED): Member, American Academy of Arts and Sciences (1979) Member, National Academy of Sciences (1985) President, International Society for Neuroethology (1986—1989) F. O. Schmitt Prize (1987) International Prize for Biology (1990) The Lewis S. Rosenstiel Award, Brandeis University (2004) Edward M. Scolnick Prize in Neuroscience, MIT (2004) Gerard Prize, the Society for Neuroscience (2004) Karl Spencer Lashley Award, The American Philosophical Society (2004) The Peter and Patricia Gruber Prize in Neuroscience, The Society for Neuroscience (2005) Masakazu (Mark) Konishi has been one of the leaders in avian neuroethology since the early 1960’s. He is known for his idea that young birds initially remember a tutor song and use the memory as a template to guide the development of their own song. He was the fi rst to show that estrogen prevents programmed cell death in female zebra fi nches. He also pioneered work on the brain mechanisms of sound localization by barn owls. He has trained many students and postdoctoral fellows who became leading neuroethologists.
    [Show full text]
  • The Need to Shorten the Prescription Drug Approval Process
    Valparaiso University Law Review Volume 27 Number 1 Fall 1992 pp.95-137 Fall 1992 Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process Mark A. Kassel Follow this and additional works at: https://scholar.valpo.edu/vulr Part of the Law Commons Recommended Citation Mark A. Kassel, Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process, 27 Val. U. L. Rev. 95 (1992). Available at: https://scholar.valpo.edu/vulr/vol27/iss1/3 This Notes is brought to you for free and open access by the Valparaiso University Law School at ValpoScholar. It has been accepted for inclusion in Valparaiso University Law Review by an authorized administrator of ValpoScholar. For more information, please contact a ValpoScholar staff member at [email protected]. Kassel: Getting There First With the Best: The Need to Shorten the Presc Notes GETTING THERE FIRST WITH THE BEST: THE NEED TO SHORTEN THE PRESCRIPTION DRUG APPROVAL PROCESS I. INTRODUCTION Due to unnecessary time delays, high costs and safety concerns, drug regulation in the United States is in need of reform.' The United States consistently lags behind the rest of the developed world in the approval of new, innovative, and efficient medications.2 Therefore, the Food and Drug Administration (FDA) needs to implement creative and effective changes in the prescription drug approval process3 in order to protect the health of the American public. Most Americans think that the FDA's stringent process for approving new prescription drugs guarantees that prescription drugs are successfully monitored.4 The American public assumes that safe and innovative drugs are made available to the public as quickly' and cost effectively6 as possible, while unsafe7 products are kept off the market.' However, this confidence placed in the FDA is unwarranted.
    [Show full text]
  • Donald Griffin Was Able to Affect a Major Revolution in What Scien- Tists Do and Think About the Cognition of Nonhuman Ani- Mals
    NATIONAL ACADEMY OF SCIENCES DONALD R. GRIFFIN 1915– 2003 A Biographical Memoir by CHARLES G. GROSS Any opinions expressed in this memoir are those of the author and do not necessarily reflect the views of the National Academy of Sciences. Biographical Memoirs, VOLUME 86 PUBLISHED 2005 BY THE NATIONAL ACADEMIES PRESS WASHINGTON, D.C. DONALD R. GRIFFIN August 3, 1915–November 7, 2003 BY CHARLES G. GROSS OST SCIENTISTS SEEK—but never attain—two goals. The M first is to discover something so new as to have been previously inconceivable. The second is to radically change the way the natural world is viewed. Don Griffin did both. He discovered (with Robert Galambos) a new and unique sensory world, echolocation, in which bats can perceive their surroundings by listening to echoes of ultrasonic sounds that they produce. In addition, he brought the study of animal consciousness back from the limbo of forbidden topics to make it a central subject in the contemporary study of brain and behavior. EARLY YEARS Donald R. (Redfield) Griffin was born in Southampton, New York, but spent his early childhood in an eighteenth- century farmhouse in a rural area near Scarsdale, New York. His father, Henry Farrand Griffin, was a serious amateur historian and novelist, who worked as a reporter and in advertising before retiring early to pursue his literary inter- ests. His mother, Mary Whitney Redfield, read to him so much that his father feared for his ability to learn to read. His favorite books were Ernest Thompson Seton’s animal 3 4 BIOGRAPHICAL MEMOIRS stories and the National Geographic Magazine’s Mammals of North America.
    [Show full text]
  • The National Academies Committee on a New Government-University
    NOTE: This is an unedited verbatim transcript of the Workshop on a New Government-University Partnership for Science and Security held at Stanford University on September 27-28, 2006. It was prepared by CASET Associates and is not an official report of The National Academies. Opinions and statements included in the transcript are solely those of the individual persons or participants at the workshop, and are not necessarily adopted or endorsed or verified as accurate by The National Academies. The National Academies Committee on a New Government-University Partnership for Science and Security September 28, 2006 Stanford University Bechtel Conference Center 616 Serra Mall, Encina Hall Stanford, CA Proceedings by: CASET Associates, Ltd. 10201 Lee Highway, suite 180 Fairfax, Virginia 22030 (703) 352-0091 NOTE: This is an unedited verbatim transcript of the Workshop on a New Government-University Partnership for Science and Security held at Stanford University on September 27-28, 2006. It was prepared by CASET Associates and is not an official report of The National Academies. Opinions and statements included in the transcript are solely those of the individual persons or participants at the workshop, and are not necessarily adopted or endorsed or verified as accurate by The National Academies. TABLE OF CONTENTS Page Introductions and Purpose of Meeting Jacques S. Gansler and Alice P. Gast 1 Security Concerns at National and University Laboratories Siegfried S. Hecker 3 Discussion 26 International Collaborations Jonathan Dorfan 40 Discussion 56 National Security and Academic Publishing Donald Kennedy 64 Discussion 77 Open Discussion: Moving Forward 86 NOTE: This is an unedited verbatim transcript of the Workshop on a New Government-University Partnership for Science and Security held at Stanford University on September 27-28, 2006.
    [Show full text]
  • The FDAAA's New Website
    Recipient of the Frances O. Kelsey Award for Courage and Excellence in Protecting the Public Health The FDAAA’s New Website (Still at www.fdaaa.org ) We are so pleased to unveil our new website. Not only is this modernized website more attractive and easier to follow, it has great new features such as members-only access to a growing collection of FDA- related information, a skills inventory, and the ability to chat with other members behind a secure firewall. This website will take us into a new era when FDAAA does even more to support your ongoing enrichment, connection to each other and to FDA, and your ability to locate resources, colleagues, friends, and experts. The FDA Alumni Association is the official global network of former and current FDA employees, connecting and supporting alumni, the Agency, and the public health community. Please be active in FDAAA and help us to make a difference. In speaking about FDAAA, then-Commissioner Ned Sharpless recently reminded us of a key quote from Margaret Mead: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” Members are encouraged to visit the Newsletter - Updates for the latest edition of the Newsletter, July 2020. Deb Autor, Chair Board of Directors FDA ALUMNI ASSOCIATION SAVE THE DATE…for our first FDA Alumni Association VIRTUAL Speaker Series Event! We are thrilled to have Dr. Luciana Borio (former Director for Medical and Biodefense Preparedness Policy for the White House National Security Council and former Acting Chief Scientist and Assistant Commissioner for Counterterrorism and Emerging Threats at FDA ) as our guest speaker on COVID-19 issues.
    [Show full text]
  • Improving the Efficiency of the Later Stages of the Drug Development Process: Survey Results from the Industry, Academia, and the FDA
    Improving the Efficiency of the Later Stages of the Drug Development Process: Survey Results from the Industry, Academia, and the FDA By Adrian Hedley Benjamin Gottschalk B.S. Biochemistry Texas A&M University, 1997 M.B.A. MIT Sloan School of Management, 2003 SUBMITTED TO THE HARVARD-MIT DIVISION OF HEALTH SCIENCES AND TECHNOLOGY IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE IN HEALTH SCIENCES AND TECHNOLOGY AT THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY JUNE 2004 © 2004 Massachusetts Institute of Technology All rights reserved Signature of Author: ____________________________________________________________ Harvard-MIT Division of Health Sciences and Technology May 7, 2004 Certified by: __________________________________________________________________ Ernst R. Berndt Professor of Applied Economics Thesis Co-supervisor Certified by: __________________________________________________________________ Joseph V. Bonventre Professor of Medicine and Health Sciences and Technology Co-Director, Harvard-MIT Division of Health Sciences and Technology Thesis Co-supervisor Accepted by: __________________________________________________________________ Martha Gray Professor of Medical and Electrical Engineering Co-Director, Harvard-MIT Division of Health Sciences and Technology Improving the Efficiency of the Later Stages of the Drug Development Process: Survey Results from the Industry, Academia, and the FDA By Adrian Hedley Benjamin Gottschalk Submitted to the Harvard-MIT Division of Health Sciences and Technology on May 7, 2004 in Partial Fulfillment of the Requirements for the Degree of Master of Science in Biomedical Enterprise ABSTRACT Drug development in the United States is a lengthy and expensive endeavor. It is estimated that average development times range from eleven to fifteen years and exceed costs of one billion dollars. The development pathway includes basic scientific discovery, pre-clinical testing in animals, clinical development in humans, and an application process.
    [Show full text]
  • Stanford Lawyer Spring/Summer 1981 Volume 16, NO.1
    Stanford Lawyer Spring/Summer 1981 Volume 16, NO.1 Editor: Cheryl W. Ritchie Associate Editor: Sara Wood Designer: Jim M'Guinness Dean's Page 2 Charles J. Meyers: A Leader in the Stanford Tradition 4 An Interview with the School's Eighth Dean Mediation-An Alternative to Adversary Divorce 10 by George H. Norton '57 Child Custody Disputes: Are We Abandoning the Child's 16 Best Interests? by Michael S. Wald, Professor of Law Home v. Public Education: Should Parents Have the Right 20 To Choose? by Thomas J. Owen '81 and Marjorie Horton Thinking About Children's Rights-Moving Beyond Kiddie Libbers 24 and Child Savers by Robert H. Mnookin, Visiting Professor of Law Stanford's Clinical Course in Juvenile Law: Combining Simulated 31 with Actual Courtroom Experience And When They're Not Practicing Law. .. 33 How Seven Alumni Spend Their uLeisure" Time Faculty Opinion: Putting the Crisis in EI Salvador in Perspective 39 by William B. Gould, Professor of Law Kudos for Stanford Supreme Court Advocate 40 Nation's First Professorship in Law and Business Established 41 at the School School and Faculty News 42 Class Notes 51 In Memoriam 71 Stanford Lawyer is published semi-annually for alumni/ae and friends of Stanford Law School. Materials for publication and correspondence are welcome and should be sent to the Editor, Stanford Lawyer, Stanford Law School, Crown Quadrangle, Stanford, CA 94305. ©1981 by the,Board of Trustees of the Leland Stanford Junior University. Reproduction in whole or in part without permission of the publisher is prohibited. Cover: Portrait of Dean Charles J.
    [Show full text]
  • Robert Hahn Testimony
    R E G - M A R K E T S C E N T E R AEI Center for Regulatory and Market Studies The Future of the Internet Robert W. Hahn Testimony before the Senate Committee on Commerce, Science and Transportation Testimony 08-01 April 2008 * Robert Hahn is executive director of the Reg-Markets Center and a senior fellow at AEI, and a non-resident senior fellow at Brookings. He would like to thank Caroline Cecot and Molly Wells for research assistance. This testimony builds on research that I have done with a number of colleagues, including Robert Crandall, Robert Litan, Hal Singer, and Scott Wallsten. The views expressed in this paper reflect solely those of the author and do not necessarily reflect those of the institutions with which he is affiliated. R E G - M A R K E T S C E N T E R AEI Center for Regulatory and Market Studies The Reg-Markets Center focuses on understanding and improving regulation, market performance, and government policy. The Center provides analyses of key issues aimed at improving decisions in the public, private and not-for-profit sectors. It builds on the success of the AEI-Brookings Joint Center. The views expressed in this publication are those of the authors. ROBERT HAHN Executive Director COUNCIL OF ACADEMIC ADVISERS ROBERT E. LITAN, Co-Chairman CASS R. SUNSTEIN, Co-Chairman Brookings Institution University of Chicago KENNETH J. ARROW ROBERT CRANDALL MAUREEN CROPPER Stanford University Brookings Institution University of Maryland JOHN D. GRAHAM PAUL L. JOSKOW DONALD KENNEDY Pardee RAND Massachusetts Institute Stanford University Graduate School of Technology MARK MCCLELLAN ROGER G.
    [Show full text]
  • 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.
    [Show full text]
  • Ethanol: Law, Economics, and Politics
    R E G - M A R K E T S C E N T E R Ethanol: Law, Economics, and Politics Robert W. Hahn* Working Paper 08-02 January 2008 This paper is forthcoming in the Stanford Law and Policy Review. This paper can be downloaded free of charge from the Social Science Research Network at http://ssrn.com/abstract=1082079 * Mr. Hahn is co-founder and executive director of the AEI-Brookings Joint Center and a scholar at AEI. He would like to thank Bruce Gardner and Al McGartland for helpful comments. He especially thanks Peter Nagelhout for answering detailed questions about the underlying economic and environmental components of ethanol. Caroline Cecot, Ryan Hughes, and Molly Wells provided valuable research assistance. The views expressed in this paper reflect those of the author and do not necessarily reflect those of the institutions with which he is affiliated. R E G - M A R K E T S C E N T E R AEI Center for Regulatory and Market Studies The Reg-Markets Center focuses on understanding and improving regulation, market performance, and government policy. The Center provides analyses of key issues aimed at improving decisions in the public, private and not-for-profit sectors. It builds on the success of the AEI-Brookings Joint Center. The views expressed in this publication are those of the authors. ROBERT HAHN Executive Director COUNCIL OF ACADEMIC ADVISERS ROBERT E. LITAN, Co-Chairman CASS R. SUNSTEIN, Co-Chairman Brookings Institution University of Chicago KENNETH J. ARROW ROBERT CRANDALL MAUREEN CROPPER Stanford University Brookings Institution University of Maryland JOHN D.
    [Show full text]
  • Bad Weather: on Planetary Crisis Author(S): Joseph Masco Source: Social Studies of Science, Vol
    Bad Weather: On Planetary Crisis Author(s): Joseph Masco Source: Social Studies of Science, Vol. 40, No. 1 (February 2010), pp. 7-40 Published by: Sage Publications, Ltd. Stable URL: https://www.jstor.org/stable/27793340 Accessed: 11-01-2019 21:21 UTC JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact [email protected]. Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at https://about.jstor.org/terms Sage Publications, Ltd. is collaborating with JSTOR to digitize, preserve and extend access to Social Studies of Science This content downloaded from 216.165.95.182 on Fri, 11 Jan 2019 21:21:30 UTC All use subject to https://about.jstor.org/terms sss ABSTRACT How, and when, does it become possible to conceptualize a truly planetary crisis? The Cold War nuclear arms race installed one powerful concept of planetary crisis in American culture. The science enabling the US nuclear arsenal, however, also produced unintended byproducts: notably, a radical new investment in the earth sciences. Cold War nuclear science ultimately produced not only bombs, but also a new understanding of the earth as biosphere. Thus, the image of planetary crisis in the US was increasingly doubled during the Cold War - the immediacy of nuclear threat matched by concerns about rapid environmental change and the cumulative effects of industrial civilization on a fragile biosphere.
    [Show full text]