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LCF Final 710 DEIR DEIS Comment Letter 8-4-15 - Part2

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LCF Final 710 DEIR DEIS Comment Letter 8-4-15 - Part2
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If.. N r WEN G LAN]) J () URN ;\ L :\1 L ])!< E race or ethnic group. This model explained 71 per- cent of the variance in the attained FEV1 level. For each subject, we then computed the predicted FEV1 from the model and considered subjects to have a low FEV1 if the ratio of observed to predicted FEV1 was less than 80 percent. Linear regression was then used to examine the correlation between the com- munity-specific proportion of subjects with a low FEV1 and the average level of each pollutant from 1994 through 2000. This model included a commu- nity-specific random effect to account for residual variation. Regression procedures in SAS software 16 were used to fit all models. Associations denoted as statistically significant were those that yielded a P value ofless than 0.05, assuming a two-sided al- ternative hypothesis. RESULTS From 1994 through 2000, there was substantial variation in the average levels of study pollutants across the 12 communities, with relatively little year- to-year variation in the annual levels within each community (Fig. 1). From 1994 through 2000, the 80 Z- (>. 70 .2: E 60 ... '0 50 S IE 40 .. 30 0 .... E 20 10 0 AL AT 45 40 35 Z- 30 Q. 25 .2: 6' 20 Z 15 10 0 AL AT l4 12 z- 10 .2: a 8 (>. -5: 6 "Q 4 0 AL AT 80 70 60 50 .. ,:. 40 '" :i 30 20 10 0 LE LA LN LM LB ML RV SD SM UP 35 30 25 .. 20 ,:. ::l 15 :::E lO - !If 0 LE LA LN LM LB ML RV SD SM UP 1.6 E 1,4 .. 12 ,:. &: 1.0 " 0.8 0.6 '" 0,4 i ill 02 ,i 0.0 LE LA LN LM LB ML RV SD SM UP Community AL AT LE LA LN LM LB ML RV SD SM UP AL AT LE LA LN LM LB ML RV SD SM UP AL AT LE LA LN LM LB ML RV SD SM UP Community Figure L Mean (+SD) Annual Average Levels of Pollutants from 1994 through 2000 in the 12 Study Communities In Southern California. AL denotes Alpine, AT Atascadero, LE Lake Elsinore, LA Lake Arrowhead, LN Lancaster, LM Lompoc, LB Long Beach, ML Mira Loma, RV Riverside, SO San Dimas, SM Santa Maria, and UP Upland. 0, denotes ozone, NO, nitrogen dioxide, and PM 10 and PM ... particulate matter with an aerodynamic diameter ofless than 10 Jim and less than 2.5 11m, respectively. N ENGL) "'ED 351;11 WWW.NE) .... O.G SEPn"'OE. 9.2004 The New England Journal of Medicine Downloaded from nejm.org on June J, 2015. For personal use only. No other uses without permission. Copyright © 2004 Massachusetts Medical Society. All rights reserved. 1060
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If..Nr WEN G LAN])J()URN ;\ L:\1L ])!.70.2:E 60... '0 50SIE 40..300.... E20~10o ~0AL AT454035Z-30Q. 25.2:6' 20Z 15100 AL ATl412z- 10~.2:a8(>.-5:6"Q ~ 40AL AT807060~ 50..,:.40'" :i30~20100LE LALN LM LB ML RV SD SM UP3530~25.. 20,:. ::l 15:::E~lO-!If 0LE LA LN LM LB ML RV SD SM UP1.6E 1,4.. 12,:.&: 1.0~" 0.8~0.6'"0,4i ill 02~ ,i 0.0LE LA LN LM LB ML RV SD SM UPCommunityAL AT LE LALN LM LB ML RV SD SM UPAL AT LE LA LN LM LB ML RV SD SM UPAL AT LE LALN LM LB ML RV SD SM UPCommunityFigureL Mean (+SD)AnnualAverageLevelsof Pollutantsfrom 1994through2000inthe12StudyCommunitiesIn SouthernCalifornia.AL denotesAlpine, AT Atascadero, LE Lake Elsinore, LA Lake Arrowhead, LN Lancaster, LM Lompoc, LB Long Beach, ML Mira Loma, RVRiverside, SOSan Dimas,SM SantaMaria,andUP Upland.0,denotesozone, NO,nitrogendioxide, and PM10and PM...particulatematterwith an aerodynamicdiameteroflessthan10Jim and lessthan2.511m, respectively.N ENGL) "'ED 351;11 WWW.NE) .... O.G SEPn"'OE. 9.2004 TheNewEnglandJournal ofMedicine Downloadedfrom nejm.orgonJune J, 2015. Forpersonal useonly. Nootheruseswithoutpermission. Copyright 2004Massachusetts MedicalSociety.All rightsreserved. 1060EFFECT OF AIR POLLUTION ON LUNG DEVELOPMENT IN CHILDRENaverage levelsof ozonewerenotsignificantlycor-related across communities with anyother studypollutant(Table1).However,correlationsbetweenotherpairsofpollutantswereallsignificant,rang-ingfromanRofO.64(P'.... 0 LM +SM .lE10 20 30 40PM10 (JIg/m')50 60 70R.O.79P.0.002 UP

.SDAT. SM .lES 10 15 20 25 30 PM2.5(lIg/ml) R-0.74 UPPQ.006

LB At .SDLA. :!,-__.LE 0 6 8 10 12LI-0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4Acid Vapor (ppb) ElementalCarbon (JIg/ml)Figure3.CommunitySpeclficProportionofl8Year-OldswithaFEV1below80PercentofthePredictedValuePlottedagainsttheAverageLevelsof Pollutantsfrom 1994through2000. Thecorrelationcoefficient(R) and pvalueareshown for eachcomparison.ALdenotesAlpine. AT Atascadero, LE Lake ElSinore, LA Lake Arrowhead, lNLancaster. LM lompoc, LB Long Beach, ML Mira Loma, RV Riverside, SD San Dimas, SM Santa Maria,andUP Upland. 03denotesozone, NO.nitrogendioxide,and PM,oand PM. particulatematterwith an aerodynamicdiameteroflessthan1011m and lessthan 2.5 11m, respectively. marilyattributabletodifferencesinthenumberofalveoli,sincetheirsizeisrelativelyconstant. 34How-ever, sincethepostnatalincreaseinthenumberofalveoliiscompletebytheageof10years,pollution-relateddeficitsinthegrowthofFVCandFEV1dur-ingadolescencemay,inpart,reflectareductioninthegrowthofalveoli.Anotherplausiblemechanismoftheeffectofairpollutiononlungdevelopmentisairwayinflammation,suchasoccursinbronchioli-tis;suchchangeshavebeenobservedintheairwaysofsmokers and ofsubjects who lived in pollutedenvironments.3536Astrengthofourstudywasthelong-term,pro-spectivefollow-upofalargecohort,withexposureandoutcomedatacollectedinaconsistentmannerthroughoutthestudyperiod. As inanyepidemio-logicstudy, however, theobservedeffectscouldbebiased by underlyingassociationsof theexposureand outcome to someconfoundingvariables. Weadjustedforknownpotentialconfounders,includ-NENGLJMEO351;11WWW.NEJM.ORGSEPTEMBER9,2004 The New EnglandJournal ofMedicine Downloadedfrom nejm.orgonJune 1,2015.Forpersonal useonly. Nootheruseswithoutpennission. Copyright2004Massachusetts MedicalSociety.Allrightsreserved. 1065ingpersonalcharacteristics and othersources of wereassociatedwiththesedeficitsincludednitro-exposureto pollutants,butthepossibilityofcon- gendioxide,acidvapor,PMl.5, andelementalcar-foundingbyotherfactorsstillexists.Overtheeight- bon.Thesepollutantsareproductsofprimaryfuelyearfollow-upperiod,approximately10percentof combustion,andsincetheyare presentatsimilarstudysubjectswerelosttofollow-upeachyear. At- levelsin manyotherareas,37,38webelievethatourtritionisapotentialsourceofbiasinacohortstudy resultscanbegeneralizedtochildrenlivingoutsideiflosstofollow-upisrelatedtobothexposureand southernCalifornia.Giventhemagnitudeoftheob-outcome.However,wedidnotseeevidencethatthe servedeffectsandtheimportanceoflungfunctionlossofsubjectswasrelatedtoeitherbaselinelung asadeterminantofmorbidityandmortalityduringfunctionorexposuretoairpollution. Inaddition, adulthood, continuedemphasisontheidentifica-we observed significant associations between air tionofstrategiesforreducinglevelsofurbanairpol-pollutionandlunggrowthinthesubgroupofchil- lutantsiswarranted.drenwhowerefollowedforthe full eightyears ofSupportedinpartbyacontract(A033-186)withtheCaliforniaAirResources Board, grants (5P30ES07048 and 1P01ES11627) ITomthestudy, witheffects thatweresimilarinmagni-the National Institute ofEnvironmental Health Sciences, and thetudetothoseinthegroupasawhole,thusmakingHastingsFoundation.lossofsubjectsanunlikelysourceofbias.We are indebted to Morton Uppmann, Jonathan Samet, FrankSpeizer,JohnSpengler,ScottZeger,PaulEnright,WilliamUnn,andWe have shown that exposure to ambient airDane Westerdahl for important advice; to the school principals,pollution is correlatedwith significantdeficits inteachers,students,andparentsineachofthe12studycommunitiesrespiratorygrowthoveraneight-yearperiod,lead-for theircooperation,andespecially to the members ofthe healthtestingfield teamfortheirefforts.ingtoclinicallyimportantdeficitsinlungfunctionattheageof18years. ThespecificpollutantsthatRFf!:RE NeES 1. Frischer T. Studnicka M, Gartner C. ofinhalableparticleson respiratoryhealth 17. TagerIB, WeissST,MunozA, RosnerB, et al. Lung function growth and ambient ofchildren. Am Rev Respir Dis 1989;139: SpeizerFE. Longitudinalstudyoftheeffects ozone: a three-year population study in 587-94. ofmaternal smoking on pulmonary func-schoolchildren.AmJRespirCritCareMed 9. SchwartzJ. Lung function and chronic tion in children. NEngl JMed 1983,309: 1999;160:390-6. exposure to airpollution: across-sectional 699-703. 2. JedrychowskiW,FlakE. MrozE.Thead- analysis ofNHANES 11. Environ Res 1989, 18. WangX, Wypij D, GoldDR,etaI. Alon-verseeffectoflowlevelsofambientairpol- 50:309-21. gitudinal study ofthe effects ofparental lutantsonlungfunction growth inpreado- 10. RaizenneM,NeasLM, DamokoshAI,et smokingonpulmonaryfunctioninchildren lescent children. Environ Health Perspect al. Healtheffects ofacid aerosolsonNorth 6-18years. AmJRespirCritCareMed 1994, 1999;107:669-74. American children: pulmonary function. 149:1420-5. 3. Horak FJr, Studnicka M, Gartner C. EnvironHealthPerspect1996;104:506-14. 19. TagerI, Munoz A, Rosner B, Weiss ST, eta!. Particulate matter and lung function 11. Committee ofthe Environmental and Carey v, Speizer FE. Effect of cigarette growthinchildren:a3-yrfollow-upstudyin OccupationalHealthAssemblyoftheAmer- smokingonthepulmonaryfunctionofchil-Austrianschoolchildren.EurRespirJ 2002, icanThoracicSociety. Healtheffects ofout- dren and adolescents. Am Rev Respir Dis 19:838-45. door air pollution. Am J Respir Crit Care 1985,131:752-9. 4. GaudermanWI,McConnellR. Gilliland Med1996;153:3-50,477-98. 20. Mckean M, Leech M, Lambert PC, P, et at Association between air pollution 12. PetersJM, AvolE, GaudermanWI, etaI. HewittC,MyintS, SilvermanM. Amodelof andlungfunction growthin southernCali- AstudyoftwelveSouthern Californiacom- viralwheezein nonasthmaticadults: symp-fornia children. AmJRespirCritCareMed munitieswithdifferinglevelsandtypesofair tomsand physiology. EurRespirJ2001,18: 2000:162:1383-90. pollution.[I. Effectsonpulmonaryfunction. 23-32. 5. AvolEL. GaudermanWI.Tan SM, Lon- AmJRespirCritCareMed1999;159:768-75. 21. Schroeder EB, Welch VI., Couper D, don5J, PetersJM. Respiratoryeffectsofre- 13. Peters JM, Avol E, Navidi W, et al. etal. Lung function and incident coronary locatingto areas ofdifferingair pollution A studyoftwelveSouthernCaliforniacom- heart disease: the Atherosclerosis Risk in levels. Am J Respir Crit Care Med 2001, munities with differing levels and types of Communities Study. AmJEpidemiol 2003; 164:2067-72. air pollution. 1. Prevalence ofrespiratory 158:1171-81. 6. GaudermanwJ,GillilandGF.VoraH,et morbidity. AmJRespirCritCareMed 1999; 22. Schunemann HJ, Dorn j, Grant BJ, al. Association between air pollution and 159:760-7. Winkelstein WJr, Trevisan M. Pulmonary lungfunctiongrOwtb insouthernCalifornia 14. Wang X, Dockery DW, Wypij D. et aI. functionisalong-termpredictorofmortali-children:resultsITomasecondcohort.AmJ Pulmonaryfunction growthvelocityinchil- ryinthegeneralpopulation:29-yenrfollow-RespirCritCareMed2002,166:76-84. dren6to18yearsofage.AmRevRespirDis upoftheBuffalo Health Study.Chest2000, 7. Ware jH. Ferris BG Jr. Dockery DW, 1993,148:1502-8. 118:656-64. SpenglerID, Stram DO, SpeizerFE. Effects IS. Elemental carbon (diesel exhaust). In: 23. Knuiman MW, James AL, Davitini ML, of ambient sulfur oxides and suspended N[OSH manualofanalytical methods. No. RyanG,BartholomewHC, MuskAW. Lung particles on respiratoryhealth ofpreadoles- 5040. Issue 3 (interim report). Cincinnati: function, respiratory symptoms, and mor-centchildren.AmRevRespirDis 1986,133: National Institute for Occupational Safery tality, results from the Busselton Health 834-42. andHealth,1999. Study.AnnEpidemiol1999,9:297-306. 8. Dockery DW, Speizer FE, Stram DO, 16. SASISTATuser'sguide, version9. Cary, 24. HoleDJ,WattGC,DaveySmithG, Hart WareJH, SpenglerJD, Ferris BGJr. Effects N.C.:SASInstitute,2002. CL, Gillis CR, Hawthorne VM. Impaired NENGLJMEO35';11WWW.NEJ .... ORGSEPTE ... BER9, 2004 TheNew EnglandJournal ofMedicine Downloadedfrom nejm.org on June 1.2015.Forpersonal use only. Nootheruses withoutpennission. Copyright2004Massachusetts Medical Society. All rightsreserved. 1066EFFECTOF AIR POLLUTION ON LUNG DEVELOPMENT IN CHILDRENlungfunctionandmortalityriskinmenandwomen: findings from the Renfrow andPaisley prospective population study. BMJ1996;313:711-5.25. Kannell WB, Hubert H, Lew EA. Vitalcapacityasapredictorofcardiovasculardis-ease: the Framingham Study. Am Heart I1983;105:311-5.26. Friedman GD, Klatsky AL, SiegelaubAB. Lungfunctionandriskofmyocardialin-farctionandsuddencardiacdeath.NEnglIMed 1976;294:1071-5.27. Ashley P, Kannel! WB, Sorlie PD, Mas-son R. Pulmonary function: relation ro ag-ing, cigarettehabit, and mortality. Ann In-ternMed1975;82:739-45.28. Detels It,Tashkin DP, Sayre JW. et al.TheUCLApopUlationstudiesofchronicob-structive respiratorydisease. 9. Lung func-tionchanges associatedwith chronicexpo-sure to photochemical oxidants: acohortstudy among never-smokers. Chest 1987;92:594-603.29. Detels It,Tashkin DP, SayreJW. et al.The UCLA population studiesofCORD. X.A cohort study ofchanges in respiratoryfunction associated with chronic exposuretoSOx.NOx,andhydrocarbons.AmJPublicHealth 1991;81:350-9.30. TashkinDP, DetelsIt, SimmonsM.etal.TheUCLApopulationstudiesofchronicob-structiverespiratorydisease.XI. Impactofairpollutionandsmokingonannualchangeinforcedexpiraroryvolumeinonesecond.Am JRespirCritCareMed1994;149:1209-17.31. Tager lB. Air pollution and lung func-tion growth: is itozone'Am JRespir CritCareMed1999;160:387-9.32. Avol EL. NavidiWC, RappaportER. Pe-tersJM. Acuteeffects ofambientozoneonasthmatic, wheezy, and healthy children.Res Rep HealthEfflnst1998;82:1-30.33. SarnatJA, SchwartzJ. Catalano PI, SuhHH.Gaseouspollutantsinparticulatematterepidemiology: confounders or surrogates?EnvironHealthPerspect2001;109:1053-61.34. Ochs M, Nyengaard JR. Jung A. etal.The numberofalveoli in the human lung.AmJRespirCritCareMed2004;169:120-4.35. ChurgA, Brauer M, del Carmen Avila-Casado M, Fortoul TI, Wright JL. Chronicexposuretohighlevelsofparticulateairpol-lution and small airway remodeling. Envi-ron HealthPerspect2003;111:714-8.36. SherwinRP, RichtersV, KraftP,RichtersA. Centriacinar region inflammatory dis-ease in young individuals: a comparativestudy ofMiami and Los Angeles residents.VirchowsArch2000;437:422-8.37. TolockaM,SolomonP, MitchellW,Nor-risG,GemmillD,WienerR.EastVS. Westinthe US: chemical characteristics ofPM2.5duringthewinterof1999.AerosolSciTech-nol 2001;34:88-96.38. Latest findings on national airquality:2002 status and trends. Research TrianglePark,N.C.: EnvironmentalProtectionAgen-cy,2003. (Reportno.454/K-03-001.)COP1right 2004 MassachusettsMedicalSociety. FULL TEXTOFALL JOURNALARTICLESONTHEWORLDWIDEWEB Access to thecompletetextof theJournal ontheInternetis freeto allsubscribers.To usethisWeb site,subscribersshouldgototheJournal'shomepage(www,nejm.org)and registerby enteringtheirnamesandsubscriber numbersas theyappearon theirmailinglabels.Afterthisone-timeregistration,subscriberscanusetheirpasswordstologonforelectronicaccess totheentireJournalfromanycomputerthatis connectedtotheInternet. Features includealibraryof all issuessinceJanuary 1993andabstractssinceJanuary1975,afull-textsearchcapacity,andapersonalarchiveforsavingarticlesandsearchresultsof interest.All articlescanbeprintedin aformatthatisvirtuallyidenticalrothatofthetypesetpages.Beginningsixmonthsafterpublication,thefull textofaU OriginalArticlesandSpecialArticlesisavailablefree ro nonsubscriberswho havecompletedabriefregistration.NENGL)MEO3S';11 WWW.NE)M.ORGSEPTEMBER9, 2004 The New EnglandJournal ofMedicine Downloadedfrom nejm.orgon June 1,2015.Forpersonal use only. Nootheruses withoutpermission. Copyright2004 Massachusetts Medical Society. All rightsreserved. 1067EXHIBIT 3 AHA Scientific Statelnent Particulate MatterAir Pollution and CardiovascularDisease An Update to theScientificStatementFromthe American HeartAssociation RobertD. Brook, MD, Chair; Sanjay Rajagopalan, MD; C. Arden Pope III, PhD; Jeffrey R. Brook, PhD; Aruni Bhatnagar, PhD, FAHA; Ana V. Diez-Roux, MD, PhD, MPH; Fernando Holguin, MD; Yuling Hong, MD, PhD, FARA; Russell V. Luepker, MD, MS, FAHA; Murray A. Mittleman, MD, DrPH, FARA; AnnettePeters, PhD; David Siscovick, MD, MPH, FARA; Sidney C. Smith, Jr, MD, FAHA; LaurieWhitsel, PhD; Joel D. Kaufman, MD, MPH; on behalfofthe American HeartAssociation Council on Epidemiology and Prevention, Council on the Kidney in CardiovascularDisease, and Council onNutrition, Physical Activity and Metabolism Abstract-In2004, the first American Heart Association scientific statement on "Air Pollution and CardiovascularDisease" concludedthatexposuretoparticulatematter(PM) airpollutioncontributes to cardiovascularmorbidity andmortality. Intheinterim, numerousstudies haveexpandedourunderstandingofthis associationandfurtherelucidatedthephysiologicalandmolecularmechanismsinvolved.ThemainobjectiveofthisupdatedAmericanHeartAssociationscientificstatementisto provideacomprehensivereviewofthenewevidencelinkingPMexposurewithcardiovasculardisease, with a specific focus on highlighting the clinical implications for researchers and healthcare providers. Thewriting group also sought to provide expertconsensus opinions on many aspects ofthe current state ofscience andupdated suggestions for areas offuture research. Onthe basisofthe findings ofthis review, several new conclusionswerereached, including the following: Exposureto PM


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