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Clearing the Smoke Assessing the Science Base for Tobacco Harm Reduction

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Named Organization
University of Minnesota
National Cancer Institute
NRC
European Institute of Oncology
Food and Drug Administration
Gallup Organization, The
University of Nebraska
RJ Reynolds Tobacco Company
International Standards Organization
University of Medicine and Dentistry of New Jersey
Georgetown University Medical Center
PHS
University of Oregon
Massachusetts Department of Public Health
Pinkerton Tobacco Company
Smith Kline Beecham
Brown and Williamson Tobacco Company
University of Texas Southwestern Medical Center
Lorillard Tobacco Company
Roswell Park Cancer Institute
Federal Trade Commission
FTC
FDA
University of California, Irvine
Pinney Associates
Johns Hopkins School of Medicine
University of Iowa Colleges of Public Health and Medicine
Lovelace Respiratory Research Institute
University of Virginia School of Law
University of Texas Medical School
University of Pennsylvania
Seton Hall University
University of Pennsylvania
University of California, San Diego
Campaign for Tobacco Free Kids
University of Medicine and Dentistry at New Jersey School of Public Health
R.J. Reynolds Tobacco Company
Star Scientific, Incorporated
Glaxo Wellcome Pharmacutical
Phannacia Corporation
VA Ann Arbor Healthcare System
Fagerstrom Consulting
National Chemicals Inspectorate, Sweden
University of Pittsburgh and Pinney Associates
Smoking and Health Action Foundation, Canada
DL Azarnoff Associates
Chemical Industry Institute of Toxicology, President Emeritus
Life Sciences Consultancy, The
Philip Morris
Star Tobacco and Pharmaceutical Company
Cochrane Tobacco Addiction Group
University of Texas
NIH
American Medical Association
University of Maryland
American Health Foundation
National Institute of Health Guidelines Committee
University of North Carolina
Massachusetts Institute of Technology
University of Michigan
University of Vermont
University of Rochester
Columbia University
Covington and Burling
Johns Hopkins University
Public Health Service
National Research Council
University of Alabama
CDC
Centers for Disease Control and Prevention
Philip Morris Tobacco Company
University of California, San Francisco
Georgetown University
ISO
RJR
Named Person
Boyse, Sharon
Hughes, JR
Goldberg, SR
Russell, MA
Benowitz, NL
Jarvis, M
Jones, RT
Gritz, ER
Marlatt, GA
Miller, WR
Edwards, G
Kozlowski, LT
Jackson, WK
Stockwell, T
Pomerleau, OF
Jarvik, M
West, RJ
West, R
Hatsukami, DK
Doll, R
Rose, JE
Hunt, WA
Kozlowski, L
Jacob, P
Smith, TA
Shiffman, S
Childress, AR
Henningfield, JE
Pomerleau, CS
Gorrod, JW
Jenner, P
Wahren, J
Chait, LD
Karras, A
Nemeth-Coslett, R
Foxx, RM
Sidney, S
Tekawa, IS
Gairola, CG
Pershagen, G
Hoffmann, D
Leichter, J
Halliwell, B
Sutherland, G
Breslau, N
Koopmans, JR
Benowitz, Neal
Hecht, SS
Henderson, RF
Blot, WJ
Brownson, RC
Belinsky, SA
Fagerstrom, KO
Molander, L
Nitenberg, A
Shields, PG
Domino, EF
Penn, A
Snyder, CA
Phillips, DH
Collins, AC
Kendler, KS
Levin, ED
Foulds, J
Jones, HE
Ames, BN
Cummings, KM
Tonnesen, P
Perkins, KA
Charlton, A
Fielding, JE
Borland, R
Rigotti, NA
Pentz, MA
Glantz, S
McCarthy, WJ
Lewit, E
Loft, S
Burns, David
Hammond, EC
Henry, J
Hughes, J
Cohen, JB
Davis, DL
Giovino, Gary
Glassman, AH
Parmley, William
Tyndale, R
Yamazaki, H
Tyndale, RF
Hahn, A
Armitage, A
Kabat, GC
Huber, GL
Samet, Jonathan
Sweanor, David
Gori, GB
Murray, RP
Guerin, M
Mattson, ME
Henningfield, Jack
Warner, KE
Connolly, GN
Zhu, BQ
Glantz, SA
Gray, Nigel
Slade, John
Appleton, Scott
McClellan, Roger
Pierce, JP
Winn, DM
Shy, CM
Covey, LS
Holt, PG
Greenland, S
Bohning, DE
Cohen, D
Thomas, WR
Burns, D
Ballin, Scott D
Woosley, Raymond
Connolly, Gregory
Gust, SW
Silverstein, B
Severson, HH
Kornitzer, M
Grasso, P
Corrigall, WA
Freedman, R
Dousset, N
Mullen, Patricia Dolan
Perez-Stable, EJ
Thun, MJ
Hughes, John
Hatsukami, Dorothy
McKinney, EF
Rettig, R
Stolerman, I
Ashley, David
Browne, CL
Samet, J
Yamamoto, T
Mosberg, Arnold T
Djordjevic, MV
White, EL
Glasgow, RE
Norman, A
Kanner, RE
Martin, BR
Reuter, Peter
Carchman, Richard A
Suber, Robert L
Lesmes, GR
Sobell, MB
Joseph, AM
Hurt, RD
Shiffman, Saul
Skoog, K
Behm, FM
Reznik, G
Sampson, A
Slade, J
Prue, D
Fung, YK
Byrd, GD
Lewis, JG
Celermajer, DS
Fu, Y
Mauderly, JL
Hjalmarson, A
Blondal, T
Wang, H
Shopland, Don
Reddy, S
Pierce, John
Houston, Thomas
Schneider, NG
Anthony, J
Plant, M
Wakefield, MA
Evans, W
Rajini, P
Witschi, H
Giovino, G
Jaffe, Jerome H
Cryer, PE
Iauco, David
Keast, D
Brown, RA
Fagerstrom, Karl
Anda, RF
Wang, T
Johnson, R
Kendrick, J
Wilkenfeld, Judith
Newman, RG
Rennard, Stephen
Tice, RR
Forbes, A
Djordjevic, M
Coggins, Christopher
Ross, HL
Fiore, M
Strandberg, TE
Herbert, J
Keenan, RM
Dajani, RM
Slovic, P
Wogan, Gerald
Perera, Frederica
Pearson, Thomas
Gazdar, Adi
Furie, MB
Nowak, J
Moore, D
Hutt, Peter Barton
Fagerstrom, K
Heatherton, TF
Pickworth, WB
Healy, DJ
Riehl, Tilford
Honeycutt, Rufus
Harris, RW
Johnson, JD
Sweeney, CT
Goldberg, ME
Gaworski, CL
Cinciripini, PM
Borgerding, Michael
Robinson, John H
Balls, M
Lovell, DP
Hayashi, M
Benowitz, N
Viscusi, WK
Rodricks, Joseph
Soderpalm, B
Nilsson, R
Lewin, F
Schildt, EB
Jones, C
Wang, HY
Davis, LD
Porchet, H
Swauger, James E
Stapleton, J
Sobel, R
Yost, BA
Kandel, D
Nelson, RA
Doolittle, David
Solana, Richard P
Kluger, R
Fant, RV
Hieda, Y
Notes

Author name is not available in the document Handwritten.

UCSF Code
oaf51a99
Type
list
report-scientific
chart
table
Region
Canada
Greece
Sweden
United States of America
Australia
India
Indonesia
Turkey
Bulgaria
Russian Federation
Jersey
Date Loaded
01 Dec 2004
Author
Wallace, Robert
Bondurant, Stuart
Stratton, Kathleen
Shetty, Padma
Box
0158
Author (Organization)
Institute of Medicine
IOM
Folder
bcmn0000

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! learing the Smoke Assessing the Science Base for Tobacco Harm Reduction Kathleen Stratton, Padma Shetty, Robert Wallace, and Stuart Bondurant, Editors Committee to Assess the Science Base tbr Tobacco Harm Reduction Board on Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 325223758
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CIca~'ing the Smoke: The ..%¢ienee ~a¢,c fot'Te,bacco H~rm Rcdt~¢llon COMMITTEE TO ASSESS THE SCIENCE BASE FOR TOBACCO HARM REDUCTION STUART BONDURANT, M.D. (Chair), Professor, Department of Medicine, University. of North Carolina, Chapel Hill ROBERT WALLACE, M.D., M.Sc., (Vice-Chair) Professor, Department of Epidemiology and Internal Medicine, University of Iowa Colleges of Public Health and Medicine J. RICHARD CROUT, M.D., President, Crout Consulting GARRET FITZGERALD, M.D., Professor and Chair. Department of Pharmacology, University of Pennsylvania ADI GAZDAR, M.D., Professor, Department of Pathology, University of Texas Southwestern Medical Center GARY GIOVINO, Ph.D., M.S., Senior Research Scientist, Roswell Park Cancer Institute DOROTHY HATSUKAMI, Ph.D. Professor, Department of Psychiat~, and Pb.'ychology, University of Minnesota ROGENE F. HENDERSON, Ph.D., Senior Biochemist/Toxicologist, Lovelace Respiratory Research Institute PETER REUTER, Ph.D., Professor, School of Public Affairs and Department of Criminology, University of MaD'land DAVID J. RILEY, M.D., Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School PETER SHIELDS, M.D., Professor and Chief, Cancer Genetics and Epidemiology Program, Lombardi Cancer Center, Georgetown University Medical Center JAMES WlLLERSON, M.D., Professor and Chair of Internal Medicine, Lrniversity of Texas Medical School Health Promotion and Disease Prevention Board Liaison KENNETH E. WARNER, Ph.D., Professor, Department of Health Management and Policy, School of Public Health, University of Michigan Neuroscience and Behavioral Health Board Liaison RICHARD J. BONNIE, L.L.B., John S. Battle Professor of Law, Director, Institute of Law, Psychiatry, and Public Policy, University of Virginia School of Law Consultants NEAL BENOWITZ, M.D., Professor and Chief of the Division of Clinical Pharmacology, Departments of Medicine, Biopharmaceutical Sciences, and Psychiatry; University of California, San Francisco CHRISTOPHER LOFFREDO, M.S. Ph.D., Assistant Professor, Lombardi Cancer Center, Georgetown University Medical Center V 325223759
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C'lca~'in_e lh¢ Smoke: The S¢ic~cc ~asc t'o~' Tob,l¢co H.~rm Reduction Staff KATHLEEN STRATTON, Ph.D., Study Director PADMA SHETTY, M.D., Program Officer ANN ST. CLAIRE, Senior Project Assistant ROSE MARIE MARTINEZ, Se.D., Director, Bo~d on Health Promotion and Disease Prevention TERRY PELLMAR, Ph.D., Director, Division of Neuroscience and Behavioral Health vi 325223760
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The report was reviewed by individuals chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments to assist the authors and the Institute of Medicine in making the published report as sound as possible and to ensure that the report meets institutional s~andards for objectivity, evidence, and responsiveness to the stud)" charge. The content of the review comments and the draft manuscript remain confidential to protect the integri .ty of the deliberative process. The committee wishes to thank the following individuals for their participation in the report review process: Daniel Azarnoff, D.L. Azamoff Associates Alfred Fishman, University of Pennsylvania Margaret Gilhooley, Seton Hall University Jack Henningfield, Pinney Associates Peter Barton Hurt, Covington and Burling Roger McClellan. Chemical Industry Institute of Toxicology, President Emeritus Patricia Dolan Mullen, University of Texas Peter Nowell, University of Permsylvania William Parmley, University. of California, San Francisco Thomas Pearson, University of Rochester Irrederica Perera, Columbia University John Pierce, University of California, San Diego Stephen Rennard, Urtiversity of Nebraska Joseph Rodricks, The Life Sciences Consultancy Jonathan Samet, Johns Hopkins University Thomas Schelling, University of Maryland John Slade, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School Judith Wilkenfeld, Campaign for Tobacco Free Kids Gerald Wogan, Massachusetts Institute of Technology Raymond Woosley, Georgetov~7~ University Although the reviewers listed above have provided many constructive comments and suggestions, they xvere not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by David Challoner, (review monitor) University of Florida and Hugh Tilson, (review coordinator) University of North Carolina. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain lhat an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. vii 325223761
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x Clear#Tg the Smoke there impartial and thorough assessment of the risk associated with new tobacco products rela- tive to the risk of abstinence or the risk of other tobacco products prior to marketing. Unlike new tobacco products, nicotine replacement products are subject to full disclosure of content, rigorous testing, and the regulation of marketing claims by the of the Food and Drug Administration. In addition to tobacco smoke, other forms of tobacco such as cigars, che~Sng tobacco, and snuff are also vectors of nicotine addiction and often have their own sets of serious toxic conse- quences. The latent period between beginning exposure to tobacco and the development of most of the major adverse consequences is so long that empirical, direct evidence (assessment of immediate and long-term toxicity of individual tobacco products in humans) that one tobacco product is less harmfid than another will rarely be available in time to be a basis for informing users. In the ab- sence of direct evidence, conflicting claims of the degree of harm reduction are likely and in- ~brmed usage decisions by smokers and nonsmokers will be difficult. No one knows the dose-response relations, the specific toxins, the pathogenic mechanisms, or the interrelationship between the many components of tobacco smoke with enough precision to make scientifically reliable quantitative judgments about the risk or actual harm reduction as- sociated with use of any tobacco product. Since we do not know which of mmly toxins may be the cause of specific harmful effects, we can only infer but we cannot know the health effects of the elimination of any one or several tobacco components. Further, we are just b~ginnhng to identify and understand the genetic basis and other causes of the differences in susceptibility, to toxic effects among groups or individuals that largely determine the response of an individual to a toxin. Nonetheless, it is reasonable to expect that some of the new products will reduce exposure to tobacco toxins and possibly reduce harm to some users and to others who are exposed to them. It is, therefore, urgent and important that the assessment of exposure to tobacco toxins resulting from the use of modified tobacco products or drugs be based on the best available evidence, made by the most qualified judges, and communicated to policy makers and the public com- pletely and honestly. There is little direct evidence available to serve as a basis for judgment as to the potential for harm reduction of specific new tobacco and pharmaceutical products. Therefore. an3' conclu- sions as to the relative harm of these products must necessarily be inferred from a base of indi- rect knowledge. The continuing introduction of new tobacco products with implicit or explicit claims of risk or harm reduction makes it important and urgent that the capacity, for the best pos- sible scientific assessment of these claims be put in place. Since even the availability of harm reduction products may deter some from IbIlowing the healthier course of abstinence or cessation, assessment of health claims should be based on an estimate of the effect of the product on the prevalence of smoking in the population, as well as the effect on the health risk to the individual smoker. The most reliable scientific interpretation of necessarily incomplete indirect evidence comes when individuals who are experts in the relative fields, are not biased, and are free of conflict of interest form a consensual judgment. Such a judgment based on evidence of high quality should be a requirement for a conclusion that the use of a product is in fact associated with decreased exposure to toxins and that the decreased exposure is likely to be associated with less harmful outcomes. 32fi223762
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• " Clearing the Stool;c: The Science [ta¢,c for Tobacco Hat'tll Reductiotl Preface X i Further, since these judgments of risk will necessarily be inferential because they are based on indirect and inconclusive evidence, some form of postmarketing surveillance of each product is important. The charge to the committee is to address the science base for harm reduction from tobacco. The committee concluded early in its deliberations that the science base for harm reduction will evolve over time. There will inevitably be important interactions between the types of products that are developed and the science base. There will also be interactions between any regulatory. process and the science base (the science base will influence regulation, and regulation will focus pertinent science) and, obviously, between regulations and products. For these reasons, the committee realized that the science base for harm reduction can be usefully considered only in the context of some sense of the types of specific products and of the consequences of regulation. Accordingly~ portions of this report address both general categories of potential harm reduction products and regulatory considerations. It is the strong sense of the committee that claims of less harm or risk associated with the use of tobacco products or drugs should be available--but only if four conditions are met: (I) There should be strong and widely available programs designed to avoid initiation and to achieve absti- nence; (2) There should be premarketing evidence satisfactory to a group of disinterested experts that--as the product will actually be used by consumers--there is less exposure to toxic agents without coincidental increase in harm to the individual from other smoke components or to the population from encouraging initiation or continuation of smoking, the burden of proof of asser- tions of harm reduction should rest entirely with those making the assertion: (3) The public should be fully informed of the strength of the claims as assessed by an independent panel of ex- perts. (4) There should be an effective surveillance system in place to determine short-term be- havioral and the long-term health consequences of the use of the new products. The committee wishes to express its great appreciation to the many individuals, listed in Ap- pendix B, xvho contributed generously mad substantially to it deliberations. Representatives of many health agencies as well as tobacco interests responded thoughtfully and extensively to the committee's questions. Dr. Kathleen Stratton contributed perspective, insight, meticulous attention to detail, and es- sential oversight to the work and report. This report would not be possible ~dthout her substantial and important contributions. Dr. Padma Sherry assumed responsibility for blocks of the report, and both the full report and many specific parts are testimony to her analytic, organizational, and expressive proficiency. Ann St. Claire organized the arrangements for the work of the committee with great f'messe and also made useful contributions to the anal3¢ical work of the committee. Every member of the committee is deeply appreciative of the work of Dr. Stratton: Dr. Shetty, and Ms. St. Claire. Stuart Bondurant Chair 325223763
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Ctza~'in$ the Smokc: The S¢ic~}¢c lqa~c ft'w Tobacco Harm Rcduction Clearing the Smoke Assessing the Science Base for Tobacco Harm Reduction Kathleen Stratton, Padma Shetty, Robert Wallace, and Stuart Bondurant, Editors Committee to Assess the Science Base for Tobacco Harm Reduction Board on Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 325223764
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('[caHng ~1~c S~nokc: The S¢ic,~cc Base r'o,'Toba¢¢o Harm Rc.duction NATIONAL ACADEMY PRESS * 2101 Constitution Avenue, N.W. • ~Vashington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the Food and Drug Administration prior to the March 2000 decision by the Supreme Court denying FDA comprehensive authority over tobacco products. The views presented in this report are those of the Institute of Medicine Committee to Assess the Science Base for Tobacco Harm Reduction and are not necessarily those of the funding agencies. Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's home page at w~v.nap.edu, The full text of this report is available at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. CopyTi~t 2001 by the National Academy of Sciences. All fights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded histo~'. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. 325223765
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Clcarh~g the Smoke: Th," Science F~o~¢ t'o~' Tobacco H.11'tT~ R;.(tL~C'tion National Academy o~ National Academy of Engineedno Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating socie~ of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of" Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility, for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibili .ty given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its ovvaa initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community, of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy. the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council. 325223766
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nanl du C~d~ing Info Personal Agent IIII G~t Our Catalofl News About NAP NATIONAL ACADEMY PRESS Home Contact Us Help ....---- ------.~:--:~-., , ~-----~'~*~-£-~.tr~ ~ ' ' Clearing the Smoke: The Science Base for Tobacco Harm Reduction (2001) Institute of Medicine (mo~re tit_los f~'om~10.~) Related Books Front Matter Contents S_um_ma~j Introduction P rj _nc. ip!e so f_Har~_ ..R_eduction~ Historical P~r~pe_cti_ve a_~nd_ L_e_ss.0_OS_ _Lea._med Prod UCt_S, [or ~Tqb_~_c_qg__E xp_q_s ~_e__R_ e_duc_t ion The Science Base Su _ry_eil_la_n.c_e_ fpr_t_h_e_Health and _B_eha_vi_o_r_a_l. ~o_..n_se_qu__e_nces of Harm Re_d._u_qtio_~ Implementation of a Science-Based Policy of Harm Reduction Principal__Co_0c_!u_sio_ns Nj_coti..n_e Pharmacology Tob_a_cc o S_m_ 9.k_e .~t _nd .T_o_ x_i_c9 !_o_ g y E~p_os.u_re.~n_d Biom_ar_ k_e~ A__ss_e_s~_men_t_ .in Humans Cancer Cardiovascular Disease No .np_ egplastic Res_p_i_rat_o_ry__ D i seas e s Re_pr0d_uc_tiye_an~ Dev_e_lopmental Effects Other Health Effects Append_ixA: _Prese nta_tio_n_s _a~3__d_.S_u_b_m_ iSS_ !9_ns App_e_n_dix B: Com_m~ttee__B_i_0gr_a_p__h!qa_l Sketches Appendix C: Time. Line_of__T_obocc_o Event_s i-xii xiii-xvi 1-16 17-30 31-48 49-68 69-116 117-146 147-164 165-188 189-198 199~28 229-248 249-292 293-380 381-404 405-440 441-454 455-474 475-478 479-484 485-498 The Open Book page image presentation framework is not designed to replace printed books, nor emulate H]'ML. Rather, it is a free, browsable, nonproptietary, fully and deeply searchable vers=on of the publication which we can inexpensively and quickly produce to make the material available worldwide. For most effective p~inting, use the "print" button available on each OpenBook page's tool block. The 300 '~ 150 dpi PDF linked to it is printable on your local printer More_i_0 fo _m~tipn__o_n.th.e__QPe_n _Rp0k .is a_v.a_il_ab_l¢_ [ T_pp__o_f__P~ge ] [ Oo_m_e_ ] [ Contact Us ] [ .H_e!l~ ] Copyright 2001, the National Academy Press. Page display interface copyright 1999, 2000, the National Academy Pre~s. http://books.nap.edu/books/0309072824/html/index.html 23/03/2001 325223767

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