Document np2LQe6xm76b77NJ0myOkNOL6
ee C3C5oo1rrppMooerrdaatitealTPorDoiedcpuncaotrgmRyeesnptonsibility SHS 1St. 7Pa3ul, 1M1N055133-3220
ARRE-0970
2
aM
CSeLrUuEm 1F1l(u1o9r8o9c)heempiicdaelmitorleongdiscoifnvoeustt-iogfa-ticoonusn.ty residents in CLUE I (1974) and
"This project is joint collaboration between 3M and Johns Hopkins University School of Public Health researchers. The objectiveofthis study is to analyze 358 adult sera samples that were collected in 1974 and 1989 as part of the CLUE I and CLUE II studies `conducted in Washington County, Maryland. The sera samples represent out-of-county residents who participated in the study. A total ofS9 samples are from individuals who donated in both 1974 and 1989. An additional total of 120 samples wil be analyzed in each yearofdifferent individuals. Fluorochemicals to be measured include perfluorooctanesulfonate (PFOS), perfluorooctanoate (PFOA), perfluorohexanesulfonate, Neethyl perfluorooctanesulfonamidoacetate (PFOSAA), N-methyl perfluorooctanesulfonamidoacetate (M70), perfluorooctanesulfonamidoacetate (MSS6), and perfluorooctanesulfonamide (PFOSA). The timeline for study completion, estimated at January 1, 2001, is entirely dependent upon a validated analytical method to analyze 1 mlofhuman serum for these fluorochemicals with a lower limit ofquantitation of< 10 ppb, based on high performance liquid chromatography electrospray tandem mass spectrometry methods.
000949
`TSIeTruLmEflOuForRocEheSmEicAaRl CtrHendPsRoOf PouOt-SoAf-Lcounty CLUE 11 (1989) epidemiologic investigations
residents
in
CLUE
[
1974) and
I. dRoEnaStAeErdeAbRfllCouooHdratQcoUhaeEmScioTcmaImlOusNndi.ettye-ctbaabsleedinsptehecismeernumbasnakmples of individuals who
extent do levels change over time?
in 1974 and 1989 and up what
2. pRrAodTurIchtOesN3thAMaLt CEcoo/nmBtpaAianCnKyflGu(oRsrpOoocnUhseNomrDioc:afltsi.sFplruooprooscahle)mimcanufactures widely-used upanendrdefurlsugeoodreosionecntitnaednuresosthrueilpafalotanianctdec(oPmFmOeSr)ciaaslanpreoncdesstsaesg.e mPeFtaaOlbSoslticrtoean.ncsefnPotFrrmOamtSeetsjasfbnaosltuihrelcfaialvcletyratanotnd 2mectuambuollaitciwvaesttoixnigc.itTyheresseuclietrficfnueglcatitsniomlna.owyeSrbueebddcshureeortnuoimceftsfotetaucltdsicehosonlienfsaattettyrsoalacnilddevpterrlaisnmasanptgoe.rst,suggest metabolism, membrane functions, and peroxisome proliferation, `fOlcucourEpoxactphioeosmniuacrlaellysrae(texOsplsotesonetdheteisaneld)i.cvhiAedmmuiaoclanslghsamavamelobenepgernotdhmeuocngtieintoeonrraeeldmppfolospotuylheaeetsipornesaernecuenokfnown. Tlorifopppoeeprcrtfoitlveueiolnryol.oevcNetloasneswusebusrltefanontnoiatateled(caPhmRaonOgnSeg)siiinnndsi1ve9i9rd5uumaanhdepa1t9i9c7ewnezryem2e.s1,9chpopltehmsetapenardos.ls,1e7olr6epveolsm, ciinanndliibvpeiiddduoeatleshceitpneadt1ii9cn95enaznydm$esinw1e9r9e7nhoatedd.levIteliss iunnlsekxnwcioetwshnslotofove6wlhspalptesmesxtntehonatmn at6hrepispeamc.lheauOnrnsgleys?
2dentoenr-moicnceupfaotritohnealflithyresegtxeipnmoeesreawdlhepptoohppeuurllaastteiioronun.mincTcohrniecsaesnpetrrooapvtoeisroanltsiimsoefaanfnleduxpowlrhooertcahhteeorrmyassetaudmyotnog concentrations vary bygenderor age.
3.
METFHrOomDASugust through Stroke was conducted in W
aNsohvienmgbteorn,Co1u9n74t,y,
tMheD.CamRpeafeirgrnedagtaoin38stCCLaUnRcer|
and (from
the
hiSimooegamno,f20"b.Gl3io0vo5ed wucsoelraleeCccltouiuoenntt(oyACrpaepnseicdneedrn'its)x.,1a).TthToeahlebroCifeaf2m5hpi,as8it0og2rnypefrosromnswadsoncaotmepdlbeltoegda,atorthe
tMDaiakseyena,tshaern(oduCg2Lh0UOmEcltIooDb)fewbral,oso1s9d8i9mw.ielraerBrtioeCfLhiUstEor[iiesn (mAopspternedsipexcatg1sa).iannsIttdwCbaalsnococedorpnrdaeunsodstuHeroseaspnwoemre
cfDnos.ctriaiolncnlaiiprpein(gAfpopretnrdaicxe m1e)ttaolcaodsmrspaaylwsen.t.eAPaatrttohtioaclmiopefanat3ns2d,w8we9er8reepgeairsvskeoenndsatpfoaorrotediftcurirepnqaitueedwni(ctthyabale
000950
TWhaessheiFonirgntdtiohivnsidCpuorauoljnsetcaytrerwereseifwdeierlnrltesdusaendsapswehtchoie,m"etonhusetr-efofrofor.mec,opuanarrtteicpioptanntsthwehoanaarleytnioctcohort
oaumtp-loefs-cwoiulnltbye" sgerloeucptegdafvoer abslsoaoydss(asmpelteasblien of these 59 individuals in 1974 wa
1). Fifyt"y-gnrionuep.indAivtidouraylsofin35s8he 1974 and 1989, The age distribution
a1ld.ed2vi0e:tlsiao0gneald6e5t+erymeianres-ch1a1n.geWien cwoilnlceasnntaarslayftzoielolnaoslwlsoo:vfeartghteiism2ge5r-wo4iu4tphyifenoarrissned-ri3vu6im:dfaulgsueto4r5oc-h6e4myiecaarls
stratified bsyagmepnldeerofan1d20agien.dividuals from CLUE Iand CLUE Il will toselected
Ample
Analyzed
emozcaphieDstibution
of
TotalNumber(=350)
of
SerumSample
tobe
--i--n SamdeFemialevss ibodthvuearsa(n=l59/svr)
174
1989
Males
2 2
2372
--DiffereFnemtianldeisvidualseachvear (1974,1989)
4<04-06y0rysrs >60 yrs
220
220
Males 20 20
4<04-06y0rysrs >60 yrs
20 20
20 20
tJhieaEteimien
t1h9i8s9prisopporsoavlidweadsbwerlitotwe(n1)974dataand disiibutionbyage
Ed by genderwas
mor
EF known at
tthweostaiimmpelspeersiisozdetsou.hfe5ci9orprrenolavtiigdoens abesttawteisetnictahleptowwoermoefas8u5r%emteontdestbeicatisn1e0d%ini1e974eaendb1e9t8w9eeisn0t3h,e
aCAocssshpeucamtii5vneggl7yt0,hueapnm)dewaitlnhlePpsrFtoaOvnSiddaleredavdetelivsiiatntitichoaenlaigpseo1w2gerpropoubpfmf<oo4r0re,ea4c0thh-ag6nr0o9aun5p,d%w5te6o0deaesrtteima25t,e 3103,0asnadmp3l6epsp(b40 in 3200%%dififereEnrcoeupbse.twTeheinstswaompglreouspisze(ewgi.l,l maesno aanldlowwfoomernas)t,atistical poweerrof 7290%0tao gierrn
A{FsHOsPSaoL)yyCMouEerstSaihnMswguSeshrMtieSgmBh)ieopnaartneasslsyutriecalliquwiildlcahnraolmyazteogfrorapuhpy/toel8ecsterrousmproarygatnoafnluiorcoecrhee.msipceaclts(rionmcelturdying Samples range inthe nadreeavoalfutahteelvoewresruslainmietxotfrqaucantteidtcautrivoen. (BLeLcOaQus)efgoePnReOrSposppeurlatciuornrsenetrluym
000951
mfuaosrgendPiFtbuOydSeN"o(r3t1Thhpwiesps)vtaalBtiidoNaaotnriaotlnyhtweiefcsfaotlr,tBisiosaamcnuparllreyestnitfclaryloumcnatdnheirsbaesrtnruyeddyucweildlbnyotapbperaonnailmyuzaedclun|tiolrtoh,e LLOQ 4. pRrIevSiKouFSsolBryEtihNneEa1Fs9Is7e:TsSsamndelnotroifnth1e98p9rowphoesnedthbeiosmuabrjekcetrss,vdoaltuaneasnrdedbl9oodpawteeriepcaoellected
TSCohanemcpepairivogeponofsoeadncosylulbpesocttteanbntlcioeaoltdrofiobsrekaamtesatehsriusurmteidbmaehnaekvxeacennpdottsfibogerneepnodsaassnisboilcenifabtoreredmaewcdihtechsondosfvcecorrn.efisdWeeenmticiaaslnintoyt. iionnutfteocrrnomamaletdisoonsinew)hiulhlmaasbneesv.geinvTehoncics0usritrnuedddiyvaiimdsuotahnlesg.fiSnrsoetna-sotwecipclultpobaedteiatosensraalmylieyndeeiaxfnpdeoxsapenodasliuynrgdeeod(sawstomanesarsuorredby
iidnednitvifiideuras.l iAdtentthiifsieprso.int,Sttahteirsetiicsalnod.aitnadiwviildlubael pberneesfeintteadndbyvi`rgtruoaulplsy, nwoitihnoduitviidnudailviridsuka.l
have signead confidentiality pledge. Protection
computer files in
against unauthorizedaccess roomsthatare locked when
will be not in
obtained by use,andin a
keeping the wing oft
forms
and
fDoerpsatrutdmeentnst, tehmaptliosyaelseosloofcktheedTwrhaeinninngotCeinntueser.anAdccceolslsabtoortahteosresroefcaoprpdrsoavreheed`aHsuettuahdloitrehiszewdhoonly
5 DISCLOSURE/CONSENT `particiPpearnstsonssigwneerdeargeecnreuirtaeldcionns1e9n7t4 faonrdm,inal1l9o89w.ingAtthetihrebtliomoedsaonfddbalotoad`tdoobnation,
research purposes.
For
eachof
these
campaigns,
the
consent
form
and
e used history form
for were
approved by theSchool's Committee on Human Research at its January, 2000meeting.
6. CONFAIlDEpNerTsIonAsLwIhToYa/rIeNpSrUiRcAeNdC0EShave access toourrecords must havea legitimate ppeurrspoonsaelainddenmtiufsietrssiagrneakeppltedingerof confidentiality. Records for this study that contain
jHmeaylotnhe DoetphearrttmheanntemthpaltoiyseaelssoofkteohpoetmlsTortcahkiaentidanwrgehCelenonctnkeoertdoiwrnhHueesnae.lntohTthDiienspu`aswreitnmagenindstr.ianrPaeelwrysiuonsngeaoldftbyhe
information that might be considered oforal contraceptives or hormones is.
sensitive coded in
suchasdateoflast menstrual a way that cannot be
period,
and
use
tkheey.TrTahineikngeyCeins tkeerp,tnianmaedsifafnedreandtdrreososmesfarroemtrheemovfieldes,.
. interpreted without a
WInhmeonrdeattahaanre36toybeaerussoefd tohuetside of
existenceof the Training Center, we know of no breachofconfidentiality.
tKoarthPuybTJl.hiecHeHrleezasllpstoohnuseRireb,slDeeaiprrecerhcs,toonMsso.farStehaeDnrdS.rpaGeecCo.irmHgeoenfWBfam.nakCnso,,mAss4tt1o0.c.k9D,i5r5De.ic9rt7eo5cr7t,,o(r3o0f1-t7h9e1Tr3a3i3n0i,ngaCuegnitre.r
7. COLLABORATIVE AGREEMENTS:
and J(oThhniss pHrooppkoisnals iUsninvoetrsbiitnyd.ing untilasigned agreement is executed between the 3M Company
000952
8. OTHER IRB APPROVALS NA
9. SINGLE PROJECT ASSURANCE
NA
10. PUBLICATIONS
fferoronvdmeerdtif{sr1osamg3rtheMiesmseitnnuttdeynJ.tohtTnohsceoH-daoeuatplhsosroiUfnnifthvoiersrmsawiitltilyonbweowiuotluhtdlJironehetnadisnnHttohhpeekgiphnrostjeUtcnotipvrereisistyeerensaearsrcchers
this study solely for its own teaching and research purposes,
o
11. PROPRIETARY DATA
CompaneyraonpdtiJothanysinHfooprkmiantsioUnniwvielrslibtey.addressed in thefinalagreementsignedbetween the 3M 12. BUDGET is attacherd.e budget for the work contribution ofthe investigators from Johns HopkinsUniversity
Personnel (On-campus)
NKaatmhey Helzlsouer Han-Yao Huang
RPorlinecoipnaPlrionjveescttigator Co-investigator
$R1a00t0er $3T0o,t00a0l
Gloria Zepp `Total On-Campus
Personnel
Secretary
500 200
4158,,000000
$93,000
PersonnSealnd(rOaffH-ocfafmmpauns) Clara Krumpe
Project coordinator
$400 54000
Judith Bolton `Total Off-Campus
Personnel
LDaabtoarmaatnoraygeTrechnician
300 250
18,000 5.000
Serum Bank Maintenance Costs
$27,000
(MainteCnoasntceP,erelPecatrrtiicciitpya,nrteSpalamcpelmeents) $225.00 x300 samples = $ 67,500
Other Expenses
CLoabmopruatteorrySuspuppplliieess (specimen tubes, pipettes)
$225.00
TSohtiaplpiOntghecrosEtxsp(eFnesdeEsx, dry ice shipping containers)
200.00 150.00
s_s15
T*otTaoltaPlriosjaenctesCtoismtaste(JoofhtnismeHotopkcoimnpsleUtneivweorrski.ty)
$188,075
000953
boTtyrha3evreMl.recsoesatrschbystJuodhynscoHsotspk(ie.ngs.,Uanniavleyrtsiciatly cionsvtesstbiygaNtoorrsthwwielsltbeBiboialnlaeldytdiicraeclt)lywitlo 3oMe.paiAdll
000954