Document 2R90G4oRoegjnm3Dd3nqBd3B7
`PSturdyotocols/PofrOnogopinogRsesaelarsch
1. is
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[Included
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protocol. Study is on-going. January 1, 2001)
Joint 3M/Johns Hopkins University final report is due
S3.utIydeisntoinf-igcoaitinogn.ofFiFnlaulorreopcohretmiiscdaluse iJnanHuuamryan1,T2i0s0s1ue..] [Included is 3M study protocol.
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Outpatient [Included
Claims Event is a 3M study
and Episode protocol.
`The study is on-going. Final report is due September 15, 2000.]
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Fluorine in Decatur Chemical Plant Retirees. study is on-going. Final report s due June 1,
[Included is a 2004. Interim
3M study protocol. draft reports will be
The issued.]
000945
CCorporrate Heaelth Phmysics e OCaner 2R 026.02
Corporat Tice
Gia
ow
SN ent Deparment
3M Identification of Fluorochemicals in Sera of Children in the United States
"The objective ofths study is to determine in a sample ofchildren their sera levels of perfluorooctanesulfonate (PFOS), perfluorooctanoate (PFOA), perfluorohexanesulfonate, N-cthyl perfluorooctanesulfonamidoscetate (PFOSAA), N-methyl perfluorooctanesulfonamidoacetate (M570), perluorooctanesulfonamidoacetate (MSS6), and perfluorooctanesulfonamide (PFOSA). In cooperation with the University of Minnesota Department of Pediatrics, samples will be obtained tha represent sera from L131 children (ages 2 to 12 years) from 23 states in the Urited States. The sera were collected as part ofa large clinica trial regarding group A streptococcal infections, A total of 599 samples will be ested. Sera levels will be compared to the childrens' age, sender and stateofresidence. The timeline for study completion, estimated at January 1, 2001, is entirely dependent upon a validated analytical method to analyze 0.1 ml of human serum for these fluorochemicals with a lower limitof quantitationof < 10 ppb based on high performance liquid chromatography electrospray tandem mass spectrometry methods.
000946
Corporate Proposal
Occupational
Medicine
Section/Epidemiology
Unit
March 16, 2000
Title: IdentificationofFluorochemicals in SeraofChildren in the United States `Pbuornpdoesdet:o cEavribdoenncceanthbaet foorguanndicinchoummpaonunbdlsoocdonwtaasinrienpgorttheedeilnemtehentliftleuroartiunree mchoermeictahlalny 23001y0ea6r0s pagpob. rAavnegreaignethseerguemnerpaelrfploupourloaotciotna.nesTuhlifsoniastper(imPaFrOiSly) blaevseeldsomnaypoboelewditsheirnutmhe psaumrpploesse;ofthtuhissist tiusddyififsictuoltdettoearsmcirniebethfeinldeivneglsoftsoeavneyraslpefcilfuiocrodcehmeomgircaaplshifcrogrmoutph.e serTahoef children (2 - 12 yearsofage) in the United States
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lOebvjeelcsotifvpeesr:flTuohreooobcjteacnteisvueloffonthaitse s(tPuFdOyS)is,tpoedreftleuromriooncetiannoaasteam(pPlFeOoAf)c,hildren their sera mpeertfhlyulorpoehrefxlaunoersouolcftoannaetseu,lfNo-neatmhiydlopaecreftlautoer(oMoc5t7a0n)e,suplefrofnlaumoirdoooaccteatnaetseul(fPoFnaOmSiAdAo)ac,etNa-te (M56), and perfluorooctanesulfonamide (PFOSA).
Protocol: has stored
The sera
Departmentof Pediatrics from 1,131 children (ages
at 2
the Universityof to 12 years) from
Minnesota Medical School 23 states in the United
States. The sera were collected streptococccal infections. [See
as partof Pediatrics
a large clinical trial 1998,101:86-88.]
regarding Sera were
group A obtained
between
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Pineidtiiaatlrviicssit.hasSeargareheadvetobepernovkiedpet3fMrozuepn
at to
-20C. 0.1 mi
At per
3M's request, the Department of individual. An initial pilot sample
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the largest observation in a upper limit on 95%ofthat
sample specific
of 45 individualsof a given population with confidence
age and gender will level 0.90. In this
be
an
particular study, the youngest age
the sample size ranges. On the
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especially will allow
in for
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biostatistician, Univ ofMN). analyzed in this study.
Therefore, the following samples are proposed to be
000947
Age Group Total N
2
27
3
51
4
81
5 6
122 146
7
161
8
131
135
10
109
1 7)
87 81
Total
131
Total Sampled (%) 27(100) 51(100) 81 (100) 100 (82) 80(55) 6037) 40 G31) 4030) 4037) 40 (46) 40.(49) 599(53)
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TPUilmooctahtyioCnh/ucroscth:(AGsesaorciyaOtlesPernofweislslorb,e UtnhievperrisnictiypoalfiMnivnensteisgoattoarDoinvitshiiosnporfojeOcctc.upDart.ional Darn.d JEenfvfiMraonndmeenltaanldHeDra.ltLha)rwriylZlosbeerlvewialsltsheerbvieosatsat3isMticcioa-ni.nveJsetaingaBtuorrrsi.s,TDort.alKreisstiHmaantseedn, costofthe study is $250,000.
a`nTailmyetliicnael:meTthheotdimteoliannealfyozres0t.u1dymicoomfplheutmiaonn siseernutmirfeolry tdheepseenfdleunotroucphoenmiacavallsiwdaittehdan
LLOQ of< 10 ppb. thesampleanalyses
If such will be
caommpeltehtoeddisbyvallaitdeasteudmmbeyr.JunSeta2t0i0st0i,catlhaennailtyisseesosfttimhaeteddatthaat
s1h5o,u2l0d00t.henRbeeviceomwpalnedteadppbryovOacltombaeyr
1 with take an
a draft final report additional 45 days.
written by November Therefore, a final
report should
is estimated to be the validationof
available by January the analytical method
1, 2001. A take longer
final than
report will expected.
be
delayed
000948