Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children

Lorillard

Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children

Date: 19900500/P
Length: 276 pages
87653662-87653937
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Fields

Author

Bayard, S.

Berry, M.

Brown, K.G.

Burns, M.

Calderon, R.

Chen, C.

Crawfordbrown, D.

Evans, T.

Glass, L.

Hertzberg, R.

Humble, C.G.

Koppikar, A.

Milne, K.

Peters, S.A.

Repace, J.

Ris, C.

Schneiderman, M.

Selevan, S.

Thorslund, T.W.

Walentowicz, R.

Wells, A.J.

Wiltse, J.

Type

PSCI, SCIENTIFIC PUBLICATION

BIBL, BIBLIOGRAPHY

CHAR, CHART/GRAPH/MAPS

DRAW, DRAWING

FOOT, FOOTNOTE

Alias

87653662/87653937

Area

SPEARS,ALEXANDER/EXEC CONF ROOM STORAGE

Named Organization

Intl Commission on Radiological Protecti

Natl Center for Health Statistics

Natl Research Council

NCI, Natl Cancer Inst

Nm Tumor Registry

Ny State Cancer Registry

Ny State Dept of Motor Vehicles

Office of Air + Radiation

Office of Atmospheric + Indoor Air Progr

Office of Health + Environmental Assessm

Office of Research + Development

Science Advisory Board

US Public Health Service

American Academy of Pediatrics

American Cancer Society

Canadian Pediatric Society

Co Central Cancer Registry

Epa, Environmental Protection Agency

Health Care Financing Administration

Hhs, Dept of Health and Human Services

Human Health Assessment Group

Indoor Air Division

Intl Agency for Research on Cancer

Named Person

Akiba

Albert

Altshuler

Arundel

Badre

Balter

Barker

Berkey

Black

Blair

Bland

Blot

Breslow

Brown

Brownson

Brownson, R.C.

Brunekreef

Brunnemann

Buffler

Burchfiel

Burrows

Cameron

Cass

Chappell

Charlton

Charlton, A.

Charnley

Checkoway

Chu

Coburn

Colley

Collier, A.

Comstock

Correa

Coultas

Cuddleback

Cummings

Cummings, K.M.

Dalager

Darby

Davies

Day

Dodge

Doll

Dorn

Dutau

Ekwo

Elliot

Ericksen, M.P.

Eriksen

Fennell, D.

Fergusson

Ferris

Fischer

Fleming

Fraumeni

Freedman

Friedman

Froeb

Fung

Gaffney

Galuskinova

Gao

Garfinkel

Garfinkel, J.E.

Gellerbernstein

Geng

Gillis

Godin

Goldstein

Greenberg

Greenberg, R.

Grimmer

Haenszel

Hammond

Harlap

Hasselblad

Hecht

Henderson

Henderson, F.W.

Henkle, S.

Hermann

Hey

Hiller

Hinton

Hirayama

Hoffman, D.

Hoffman, W.

Holberg

Hole

Hollander

Humble

Husgafvelpursiainen

Inoue

Jarvis, M.J.

Just

Kabat

Kahn

Kallail

Kauffmann

Kentner

Kilpatrick

Kim

Knoth

Koo

Koo, L.C.

Kuller

Kyerematen

Lam

Lam, W.K.

Layard, M.

Lebowitz

Lebowitz, M.D.

Lee

Lee, P.N.

Leeder

Lehnert

Lewtas, J.

Lowrey

Lutz

Mantel

Martonen, T.

Masi

Mauderly

Mcconnochie

Miller

Mitchell

Moolgavkar

Morrison

Murray

Murray, A.B.

Navidi

Nazaroff

Neuspiel

Ogston

Osmond

Ostro

Ostro, B.D.

Park

Parker

Partanen

Pattishall

Pedreira

Perry

Pershagen

Peto

Phillips

Pike

Pimm

Poaletti

Polydorova

Pritchard

Pullen

Rantakallio

Reed

Riboli, E.

Richardson, M.A.

Rickert

Ritchie

Roghmann

Rogot

Rowe

Russell

Sackett

Said

Samet, J.M.

Sandler

Sandler, D.

Saracci

Schenker

Schilling

Schlesselman

Schwartzbickenbach

Sepkovic

Shepard

Shimizu

Sims

Somerville

Speizer

Stanton

Stehlik

Stellman

Stern

Strachan

Surgeon General

Svenson

Svensson

Tager

Tannenbaum, S.R.

Tashkin

Teculescu

Thorslund

Thyssen

Trichopoulos

Uberla

Vainio

Vandenbroucke

Varela

Vutuc

Wald

Ware

Weibel

Weiss

Weitzman

Wells, A.J.

White

Whittemore

Wigle

Willatt

Wolfe

Woolf

Woolfe

Wynder

Yusuf

Date Loaded

05 Jun 1998

Request

R1-004

R1-039

R1-041

R1-048

R1-132

Master ID

87653565/6821
Related Documents:

Litigation

Stmn/Produced

Author (Organization)

Clement Associates

Epa, Environmental Protection Agency

Human Health Assessment Group

Indoor Air Division

Kenneth G Brown

Office of Air + Radiation

Office of Atmospheric + Indoor Air Progr

Office of Health + Environmental Assessm

Office of Research + Development

Univ of NC

Characteristic

DRFT, DRAFT

Site

G65

UCSF Legacy ID

hur21e00

Document Images

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United States Office of Health and EPAl600:6-90r006A Environmental Protection Environmental'Assessment May 1990 Agency Office of Atmospheric and External Review Draft Indoor Air Programs Washington DC 20460 Research and Development~Air and Radiation, .=.EPA Health Effects of Review Passive Smoking: Draft Assessment of (Do Not Cite or Quote) Lung Cancer in Adults and Respiratory Disorders in Children Notice This document is a preliminary draft. It has not been formally released by EPA and should not at this stage be construed to represent Agency policy. It is being circulated for comment on its technical accuracy and policy implications. l 4

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DRAFT EFA/600/6-90/006A DO NOT QUOTE OR CITE may 1990 External Review Draft HEALTH EFFECTS OF PASSIVE SMOKING: ASSESSMENT OF LUNG CANCER IN ADULTS AND RESPIRATORY DISORDERS IN CHILDREN NOTICE THIS DOCUMENT IS A PRELIMINARY DRAFT. It has not been formally released by the U.S. Environmental Protection Agency and should not at this stage be construed to represent Agency policy. It is being circulated for comment on its technical accuracy and policy implications. Office of Health and Environmental Assessment Office of Research and Development and Indoor Air Division Office of Atmospheric and Indoor Air Programs Office of Air and Radiation U.S. Environmental Protection Agency Washington, D.C.

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DRAFT--DO NOT QUOTE OR CITE DISCLAIMER This document is an external draft for review purposes only and does not constitute Agency, policy. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. ii 05/17/90

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DRAFT--DO NOT QUOTE OR CITE CONTENTS I Tables .................................................................................................... ............................ vi Figures .................................................................................................... ........................... ix Preface ....:............................................................................................... .......................... x List of Abbreviations .................................................................................................... . xii Authors, Contributors, and Reviewers ..................................................................... xiv 1. EXECUTIVE SUMMARY ..................................................................................... 1-1 1.1. ETS AND LUNG CANCER ......................................................................... 1-2 1.2. ETS AND RESPIRATORY DISORDERS IN CHILDREN ................. 1-6 2. INTRODUCTION .................................................................................................... 2-1 3. EPIDEMIOLOGIC EVIDENCE OF LUNG CANCER FROM ETS .................................................................................................... ............. 3-1 3.1. INTRO DUCTION ........................................................................:...:............... 3-1 3.2. META-ANALYSIS OF CASE-CONTROL STUDIES FROM RAW DATA .................................................................................................... .. 3-14 3.3. META-ANALYSIS OF CASE-CONTROL STUDIES THAT INCLUDE AN ADJUSTED STATISTICAL ANALYSIS .................. 3-21 3.4. EVIDENCE OF DOSE-RESPONSE IN CASE-CONTROL STUDIES WITH MORE THAN ONE EXPOSURE LEVEL .............. 3-25 3.5. BASIC ISSUES IN' POTENTIAL BIAS FROM MISCLASSIFICATION IN CASE-CONTROL STUDIES :.................... 3-31 3.5.1. Background ............................................................................................. 3-31 3.5.2. Sources of Bias ...................................................................................... 3-31 3.6. COHORT STUDIES: BACKGROUND ..................................................... 3-34 3.7. SOME COMPARATIVE ASPECTS OF THE TWO MAJOR COHORT STUDIES: HIRA(Coh) AND GARF(Coh) ............................................................................................ 3-35 3.7.1. Overview .................................................................................................. 3-35 3.7.2. Comparative Review and Discussion of the Cohort Studies-...................................................................................... ...................... 3-36 3.7.3. Comparative Data Analysis of the Cohort Studies .................................................................................................... .. 3-40 iii 05/ 17/90

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DRAFT--DO NOT QUOTE OR CITE CONTENTS (continued) 3.8. SUMMARY AND CONCLUSIONS ........................................................... 3-41 4. ASSESSMENT OF LUNG CANCER RISK FROM ETS .............................. 4-1 4.1. INTRODUCTION ............................................................................................ 4-1 4.2. PREVIOUS ESTIMATES OF RELATIVE RISK FROM EPIDEMIOLOGIC DATA ..........................:................................................. 4-3 4.2.1. The NRC Report and Wald et al. (1986) :....................................... 4-3 4.2.2. Other Risk Assessments Based on Epidemiologic Data .............................................................................. 4-8 4.3. APPROACHES TO RISK ASSESSMENT BASED ON CIGARETTE-EQUIVALENTS .................................................................... 4-15 4.4. CURRENT ASSESSMENT OF LUNG CANCER RISK ....................... 4-22 4.4.1. Combining Evidence Across Studies ....................................... I 4-23 4.4.2. Adjustment to Relative Risk for Smoker Misclassification ..................................................................................... 4-25 4.4.3. Parameter Sensitivity ............................................................................ 4-27 4.4.4. Adjustment to Relative Risk for Backgrou nd Exposure ........................................................................... 4-27 4.4.5. Population-Attributable Risk and Excess Lung Cancer Deaths ............................................................................. 4-29 4.4.6. Adjusted Relative Risk and Population- Attributable Risk by Individual Study ............................................... 4-31' 4.5. SUMMARY AND CONCLUSIONS ........................................................... 4-37 5. ENVIRONMENTAL TOBACCO SMOKE AND RESPIRATORY DISO RDERS IN CHILD REN ............................................................................... 5-1 5.1. INTRODUCTION ............................................................................................ 5-1 5.2. EXPOSURE OF CHILDREN ...................................................................... 5-3 5.3. RECENT EPIDEMIOLOGIC EVIDENCE .............................................. 5-5 5.4. RESPIRATORY SYMPTOMS ..................................................................... 5-9 5.4.1. The U.S. Surgeon General's Report on Respiratory Symptoms ......................................................................... 5-9 5.4.2. The National Research Council Report on Respiratory Symptoms ......................................................................... 5-11 iv 05/17/90

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t DRAFT--DO NOT QUOTE OR CITE CONTENTS (continued) 5.4.3. Recent Studies on Respiratory Symptoms ....................................... 5-12 5.4.4. Summary and Discussion of Respiratory Symptoms ................................................................................................ 5-16 5.5. ACUTE RESPIRATORY ILLNESS ........................................................... 5-18 5.5.1. The U.S. Surgeon General's Report on Acute Respiratory Illness ................................................................................. 5-20 5.5.2. The National Research Council1 Report on Acute Respiratory Illness .................................................................... 5-20 5.5.3. Recent Studies on Acute Respiratory Illness .................................. 5-21 5.5.4. Summary and Discussion of Respiratory Illness ............................ 5-23 5.6. PULMONARY FUNCTION ......................................................................... 5-25 5.6.1. The U.S. Surgeon General's Report on Pulmonary Fu nction ................................................................................................... 5-27 5.6.2. The National Research Council's Report on Pulmonary Function .............................................................................. 5-28 5.6.3. Recent Studies on Pulmonary Function ........................................... 5-29 5.6.4. Summary and Discussion of Pulmonary Function ......................... 5-31 5.7. RELATED RESULTS .................................................................................... 5-33 5.7.1. Middle Ear Effusion .................--......----.....------.................................. 5-33 5.7.2. Acute Upper-Respiratory-Tract Illness ............................................ 5-35 5.7.3. Asthma .................................................................................................... . 5-35 5.7.4. Symptoms in Asthmatics ...................................................................... 5-37 7.7.5. Non-Specific Ailments .......................................................................... 5-39 APPENDIX A: SUMMARY DESCRIPTIONS OF ELEVEN CASE-CONTROL STUDIES ....................................................... A-1 APPENDIX B: MATHEMATICAL FORMULAS AND RELATIONSHIPS ............................................................... B-1 APPENDIX C: DOSIMETRY OF ETS .................................................................. C-1 APPENDIX D: ALTERNATIVE APPROACHES FOR ESTIMATING THE YEARLY NUMBER OF LUNG CANCER DEATHS IN NON-SMOKERS DUE TO ETS BASED ON DOSE-RESPONSE MODELING .................................................................................... D-1 REFERENCES AND RELATED BIBLIOGRAPHY .......................................... R-1 v 05/17/90

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DRAFT--DO NOT QUOTE OR CITE TABLES 3-1 Case-control Studies of ETS: Characteristics ............................................ 3-2 3-2 Case-control Studies of ETS: Characteristics ............................................ 3-5 3-3 Case-control Studies of ETS: Sources ......................................................... 3-8 3-4 Case-control Studies of ETS: Measure of Exposure to ETS and Other Substances .......................................................................... 3-10 3-5 Case-control Studies: "Unexposed" vs. "Exposed" from Raw Data .................................................................................................. 3 -1 5 3-6 Case-control Studies: "Unexposed" vs. "Exposed" Females from Adjusted Statistical Analyses ............................................... 3'-23 3-7 Case-control Studies: Exposure Response Trends for Females .................................................................................................... ..... 3-26 3-8 Two Cohort Studies: Female Lung Cancer Data for Similar Age and Exposure Groups ................................................................ 3-42 4-1 Epidemiologic Studies Included in Overall Relative Risk in this Report (Females Only) and Several Other Sources .................................................................................................... 4'-11 4-2 Adjusted Relative Risks and Population-attributable Risk of Individual Studies (Females) ........................................................... 4-35 4-3 Population-attributable Risk by Study (Females) ...................................... 4-36 5-1 Evidence of Respiratory Disorders Related to ETS Exposure from Selected Studies Subsequent to the U.S. SG and NRC Reports of 1986 .............................................................. 5-6 5-2 Studies on Respiratory Symptoms Referenced in the U.S. SG and NRC Reports of 1986 .............................................................. 5-10 5-3 Studies on Respiratory Illness Referenced in the U.S. SG and NRC Reports of 1986 .............................................................. 5-19 5-4 Studies on Pulmonary Function References in the U:S. SG and NRC Reports of 1986 .............................................................. 5-26 vi 05/17/90

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DRAFT--DO NOT QUOTE OR CITE TABLES (continued) B-1 Definition of Terms in Equation B I Relating Observed RR (RRO) and its Value Adjusted for Misclassification (RRM) :................................................................................. B-2 B-2 Parameters and Their Alternative Specifications Required for Equation B1 ............................................................................... B-3 B-3 Conversion of Parameters Between Reported and C-1 Correct Classifications ..................................................................................... B-5 Steady State Ratio of Concentrations of Nicotine C-2 in Body Tissues or Organs .............................................................................. C- 16 Approximate Composition of Mainstream Smoke and C-3 Diluted Sidestream Smoke from One Non-filter Cigarette .................................................................................................... .......... C- 19 Summary of Concentrations and Daily Intakes for C-4 Constituents of Cigarette Smoke, Assuming Fresh SS ............................. C-22 Measurements of ETS Constituents in Environmental C-5 Settings .................................................................................................... ............ C-23 Daily Integral Organ Burdens for Particulate Phase C-6 Chemicals as Calculated in this Report ....................................................... C-32 Summary of Dose Measures Calculated in this Report ........................... C-38 C-7 Summary of Ratio of Measures (ETS/MS) Calculated in this Report ............................................------............................................ .... C-43 D-1 Selected Sources of Information Potentially Useful ~ D-2 for Deriving a Dose-Response Relationship for ETS ............................... D-5 Data That Can be Used to Obtain Relative Potency D-3 Estimates for ETS Constituents ..................................................................... D-7 Historical Lung Tumor Control Data for ` ............................................................. Osborne-Mendel Rats ......................... D-7 D-4 m Relative Potency Estimates of ETS Constituents :..................................... D-8 ~ ~ ~ D-5 Example of Animal Inhalation Dose-Response Model ~ Syrian Golden Hamsters Exposed to B[a]P Via NaCI ~ Aerosol .................................................................................................... ............ D-10 CD vii - 05/ 17/90

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DRAFT--DO NOT QUOTE OR CITE . TABLES (continued) D-6 Number of Lung Cancer Deaths and Person-Years of Observation for British Male Physicians ...................................................... D- 17 D-7 Lung Cancer Death Rates Per 100,000 Person-Years and Observed and Predicted Number of Lung Cancer Deaths Among Men and Women Who Never Smoked Regularly :...................... D-21 D-8 Relative Potency Estimates of Complex Mixtures of Incomplete Combustion Products of Hydrocarbons Compared to B[a]P ........................................................................................... D-24 D-9 Relative Potency Estimates of Agents Compared to B [a] P .................................................................................................... ........... D-25. D-10 Lung Cancer Mortality in Japanese Women by Husband's Age Group and Smoking Habits (Patient Herself a Non-Smoker) .................................................................... D-28 viii 05/ 17/90

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DRAFT--DO NOT QUOTE OR CITE FIGURES 3-1 Percentage of controls exposed to ETS by study .............................. :........ 3-13 3-2 Ordered values of the S statistic from raw data of studies in Table 3-5 ........................................................................................... 3-20 3-3 Ordered values of the S statistic from adjusted analyses of studies in Table 3-6 ..................................................... 3-24 3-4 Plots of relative risk against exposure for studiess in Table 3-7 .................................................................................................... .... 3-28 C-1 The general anatomy of the lung from the trachea down to the distal bronchioles ....................................................................... C-7 C-2 A compartmental model of the human body, displaying organs, tissues, fluids, and their interconnections ...................................... C-13 C-3 A metabolic model for the conversion of nicotine and the excretion ............................................................................................... C-35 D-1 Goodness-of-fit of two-stage model to non-smokers-- age-dependent lung cancer data ................................................................... D-22 05/17/90

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