Document kQrJ6mqa1MqXpkOvkm7d961b
. The Shanghai Health Study
Patsy Clegg
0IaIJ. ()oe!1Ignt CCmmItl..
SiIoII~1J'
May 2004
What is the Shanghai Health Study?
!II AIong-telm dinlcal study to investigate the potential causes and development of Iympho-hematopoietlc diseases (diseases of the lymphoid organs, blood and bone marrow) as related II! benzene .
o A projett of Fudan University MedlCllI Center; University of Colorado Health Sderu::es Center; Applied Health Sciences - an independent U.s. researdl firm; Chinese publi~ healtil agen<:leS; and Shanghai hospitals
Benefits to Industry
~ Set sdence-based standards to protect worl<:ers and general population from benzene-induced disease
II Mobile source air toxlcsstandards
II Water quality standards . G Site remediation deanup standards '0 Corporate responsibility and product stewardship
A , .. Shanghai Health Study Purpose
0To gain a Quantlflable understanding of the relatlonshlp between benzene exposure and potential. associated cancer risks
Path to developing the study:
o ~97: .. 97:
o 98-110: .. 0.:
o 01:
Benzene ~ IIS$OdaI<ld WIth AMl
mNO J)I.tlIlshed ~ 0lIna study that:
...."""""""--..,. 8INIMelII' CIUR! NIiL :.;...,~--
. __.......__It;_Ni:JIIettto(IoIOgyo1IIdled
fOSll:lillty lIIUdleS In SIlar9ha1 Auslnlilan Il\stltuIl! oIl'eoc1eum', {AlP)
.... ..- """""*..,...........,.,.Health Walc!1 Study
1io_wIIIHHL ..
......,"'IlenzeIle Health Reseatth COnsoroum formed W:
-lNi"MII'qUl'lSt::k::lMf1I~~I'tSSXln_~
Benzene exposure and canQf!r Conclusions from pre-J997 Epidemiology
~ Only acute myelogenous leukemia (AML.) associated with benzene
~ No ri9; at expo$IIres < 1 ppm " aear risk at expos~res :> 20 ppm " Insufficient data at 1-20 ppm to assess list;
HAZ-SHA-000279
;
~i _
The Shanghai Health Study
1. pse Conlrn! Slu!N
Traclltmal, prospet\:IYe epidemiology stI.dy 10 delBmlne risk or~!., NHL among benzene I!>qXJSEd wori<ers - 450 ~L and 450 NHL pi!!leOts --'10 stIJdy
2. DI<eag Prrm:ssJro 5lI!dy
I>ro>pettIve sb.dy on reIotianshlp d non<anrer bone """""" dIoe.al;e and benr.... Irlduced AML
Uniqueness ofShanghai Study
o prospective research ~ Patients at participating hospitals suspected of . having a lymphoid, blood or bone marrow disease wlU be referred to the SHS .
= Patients' diets, environmental exposures and
fi\mlty histories wlU be recorded ~ Patient disease progression followed at
supporting hospitalS
Uniqueness ofShanghai Study
c Study will be able to examine primary diagnOstic and medical data in real time
q) First-hand exposure reports are more
reliable than second-hand or reconstructed Information Q) State-owned databases document worker histories
Uniqueness ofShanghai Study
o Robust data set
= State-maintained benzene exposure and health
effects databases documented from 1970s
" senzene related health effects are II 2 II reported chronic occupational health hazards in Olina In 2001 (SoINre: JiIN..rryIfpub/c-_IIh)
" Large range of exposure levels from a variety of occupational sources
C Regulatory authorities Interest in improving benzene exposure regulation and
. enforcement
Quality, Independent Science
I) All protocols reviewed and approved by external Institutional Review Boards (IRB's) Govem use 01 human S>iecI$
U.s. m 0I1na Irdepetodentty
o SIIangnal Heelth Study independent review panels IntJ:miltlona! Ethlc:5 _ Panel
Intemallonal Sdendflc _ IZ members .
PiIneI
6 SClend!\c disciplines
Involved dtn1ng ....tInl projeCt
jRedacted
: 'j :...j
HAZ-SHA-000280
2
Benzene Health R.esearch Consortium Organization
OVersight Comm'tt~
/"" t I'~
Tectr1C!111Budget commutation Recruitment Legal
Sdent!flc ~ PaM! Shies RaIIIeW Panel
N'CO
Shanghai Health Study
StudY partldpa!JlS Poindpll "'~ tDrr.. _"".,.,wtiomnoid. _. u.. __ _...... _ _ CeoUf
CCIh......_ ,
Q. Fu HIWI, hOI" U"iIItr5I1 _ _...........,
-_Un..-....,S<-bm>Id_OI_Pa1tidpllllls:
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sn.!1QIWI"""""_"" _ _ Su~
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tntImIll\eIoM -.Is UdCOi>oodo. __
.
Shanghai Health Study
Study lime Une
Aug 01
31'1Q01 2002
3Q03
Aug 03 4QOJ
Aug 04
2007/8
Consortium F~
Protix::cls Reviewed Lab constructed, equIpped at Fudan; t:edlnldans trained
!!\!gao acaulng cases
Arst Annual Meeting Open\rlg Ceremony In Shanghai Setond Annual Meeting
Report
Shanghai Health Study
Redacted
Shanghai Health Study
SUmmary
.. '~to obtain a better underst3n<1ng, eI the medlanlsm 01 beNene Induced dlsease In hUllliWlS.
or\I Signlflalnllmpi'tt on tJenZ...... ~!l< U"'<IUJ!'!'!h
HIg!lesI DlJalllll Stinlc!!' empIo\' sQte...,Hhei\I't bIcIogk:aI and ~I scler<:e rep-esenl SOlI1d ~ steward>tdp ~ ~11y I>c5t ptlI(tI:es In research e\IlIcs deI>eM 'UI:>OO partnership 01 tndusUy. 9O"emmenlS. 1<:3dem1.
and publIC
3
. The Shanghai Health Study
Patsy Clegg
ChoIr, o..er>I9hl ~..
_~LP
May 2004
What is the ShanghaiHealth Study?
G A Iong-tem\ clinical study to investigate the potential causes and development of Iympho-hematopoletlc diseases (diseases of the lymphoid organs, blood and bone millTOW) as related to benzene
o A project of Fudan University Medical Center; . UniversitY of Colorado Health Sciences Center;
non;Applied Heahtl ScIences an in!lependent U.S.
research Chinese pUblic health agencies; and Shanghai hospitals
e~l~~!~~~~~
Benefits to Industry
:;) Set science-based standards to protect workers and general population from benzene-induced disease ~ Mobile source air toxlcs standards
1/ Water quality standards ~l Site remediation clean.up standards
o Corporate responsibility and product stewardship
Shanghai Health Study Purpose
eTo gain a quantifiable understanding of the relationship between benzene exposure and potential assodated
cancer riSks
Path to developing the study:
"_97: " 97:
o 9&<)0: .. 01:
" 01:
110m..... eqlO5I.Ire lIS'Odated ...1Il AMl
-A-ML-_" _ _ _ ..NO pIAlIlshed a>ndvsIon5 fnlrn OliN! slUdy !hat: - It:t'nnt raw J;:Ma Htf,. ~_-
110 ~ CJIIId>ed
fuSlblllty sludleS 11\ ~
AllSIraIlan 10$l!1IJte of _
.. (AlP)
................tieiI/tb WlIId> Study
- 100_ --~--
- ... ~_NHL ........ ..,...,..
..fbIIJr"''''''-Iletuene 1iU!III-.:n ConsortlUm!tnne<l tn:
- Ml'WCfq~fI"'JI"OIiJ~"I'lId~
Benzene exposure and cancer
Conclusions from pre-1997 Epidemiology
r:J Only acute myelogenous leukemia (AML) associated with benzene
~ No risk at exposures < 1 ppm " Oear risk: at exp05!Jres ;. 20 ppm !l Insufficient data at 1-20 ppm tIl assess risk
HAZ-SHA-000279
The Shanghai Health Study
1. WCpn!rol~ Traditional, prospecIMo ~ 5II.<!y 1 0 _ risk d AMI, NHLal!lQfl9i>euone ~ ~ 450 AMI. ~ 4SO ~Hl pa!Ietlts Ir1ID swd)I
Uniqueness ofShanghai Study
o pmspect;ye research
" Patients at participating hospitals SQSpetted of . ha'/lng a lymphoid, blood or bone martow
disease wiD be referred to the SHS
~ Patients' diets, env/rOllmelltal exposllres and Iilmlty histories wiD be reamled
It Patient disease progression followed at supporting hospitals
Uniqueness ofShanghai Study
c Study will be able to examine primary
diagnostic and medical data in real time q) First-hand exposure reports are more
reliable than second-hand or reconstructed
Information
Q) State-owned databaSes document worker
hl>tories
Uniqueness ofShanghai Study
c. Robust data set II StlIte-l'I\iIIntllined benzene exposure and health
effeds databases documented from 19705 ~ \lenzene related health effec:t:s are #2 In
reported chronic occupational hellltl1 hazards in Olina In1.001 ($wrQr:-,ci_HelIIR) ~ Large range of exposure levels from II variety 1)(
oo::upational sources o Regulatory authorities Interest in improving
benzene exposure regulation and
enforcement
Quality, Independent Science
II All pro\OCOIs revIeWed and approved by external Ire;titut:ionaI Review Boards (IRS's)
GcMom \Jse 01 human subjeds
u.s. """ 011"" IndopondEntIy
" Shanghai Healtl1 Study independent review panels Intemallonill allIeS IieYIow Pand Intemo!fonal SdmtlIIc _ PaIleI
12 membets . Ii SCIeI>1IftC; disciplines
In"""'" durInu entire I""Ject
iRedacted
HAZ-SHA-000280
2
Benzene Health Research Consortium
Organization
~OVersigh.\t
ICommlttett..... ~
Techficai/Bud9et Commutcation Recruitment legal
SclentII\C ReVoeoi Panel .Ethlcs RevIeW Panel
APCO
Shanghai Health Study
studY partidDan~
PrindpollnoreotiplDrs: .... _ .. '"'"" u.. CokncIo ...... """"" ce.~ Dr. CIllO wong, ~ I1eIaJIh Sdeftca
Df.FU~,Fu\S.lnun~
CGIIoboq.....,
_ _............
aw..PolIidpontsr ...... ""-S<IIoOI .._
.. ..n. .g,.N_I-__. . ..,.'. .""_50_..2.6..._......._I\QIIcO.Io~ID""a.-_1loO
--~
,
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1
.~
I Shanghai Health Study
I Study lime Uoe
e.
Shanghai Health Study'
Aug 01 3/4Q01 2002
3Q03 Aug 03 4Q03 Aug [)4 2007/8
Consortium Fonned
. Protocols Reviewed llIb constnJc:ted, equipped at Fudan; technldans trained Began accruing cases
First Annual Meeting Opening Ceremony In Shang hal Second Annual Meeting
Report
Redacted
Shanghai Health Study Summary
a Q.omI!lImIl)! to obli>ln a bette< undemllrdlng 01 the mec.IlanIsITI of boruI!ne indUced disease In humans.
a Signlftalnt Imi<1 on """ene rtst ~
.~~: employ sGlte-<II-the-art biological and ~I 5den<e
u ~ 5OO.I1d product stewanlship ~ty be5t practx:es In research eIhk:s .,.",.,..., upon partnerVo'p of irodustry, governments, iK3defn1.
and pUJlk:
HAZ-SHA-000281
3
_-i _
_ The Shanghai Health Study
Patsy Oegg
ChBk", ~ CDmmlt1ee Sho!J 0enICi>15, LP
.May 2004
What is the Shanghai Health Study?
e A long-term dlnlcal study to investigate the potential
causes and development of Iympho-hernatopoletic
diseases (diseil5e5 of the lymphoid organs, blood and bone marrow) as related to benzene
o A project of Fudan University Medical Center; university of COlorado Health Sciences Center; Applied Health ScienteS - an independent U.S, research firm; Chinese publIC health agehcies; and Shanghai hospitals
Benefits to Industry
~ Set science-based standards to protect workers and general population from benzene-Induced disease .
): Mobile source air toxies standards
" Water quality standards ~l Site remediation dean-up standards
~ Corporate responsibility and product stewardship
Shanghai Health Study Purpose
eTo gain a quantifiable understanding of the relationship between benzene exposure and potential associated. cancer risks
;.;
Path to developing the study:
o Pn>-97: " 97:
98oW: 01:
o 01:
- -Benz""" e><poSUre assodated With AML
NO JIl.tilsMd conclusIonS '""" OlIna stJdy that:
- Be:nl'llneUlnCMaNI1L - AMl~.'ea:pas&u"tS~lI'in~Wlwn-r,a
HO Metl'oodology oIIIdzed FeaSibility studIeS In SIlangllal AustJallan lnstltul 01 Petroleum's (AlP) Health W.td1 Study
.. ~"IDIJI~lnOudIf'IIdITonIC.tvm~
-~- ""'~ttonwt:hNHlO"mu,,*,*~
I\enzene Health Researm ConsortIUm formed \Il'
- do.audy ..... _
- IIfI5M:f quc:stionlrJ d5tIaSt pl'"ClgressiDn and ~
Benzene exposure anq cancer
Conclusions froni pre-1997 Epidemiology
o Only acute myelogenous leukemia (AML) associated with benzene
~ No rlsk at exposures < 1 ppm ~ Oear risk at exposures> 20 ppm ~ Insuffident data <It 1-20 ppm to assess risk
HAZ-SHA-000279
The Shanghai Health Study
1. 0.... Cpotm/ sliA' Tradltla1al, prospet1M! epidomIoIogy swc!y to del2lmlne risk of AJoIl, NHl omong benzene ~ wori<ers
- 450 AJoIl and 450 NHl pl>llents ~IO study
Uniqueness ofShanghai Study
o Prospective research Patients at participating hospitalS suspeOed of
" having a lymphoid, blood or bone marrow disease wlU be referred to the SHS
= Patients' diets, environmental exposures and
family histories will berecorded
~ Patient disease progression followed at
supporting hospitals
Uniqueness ofShanghai Study
o Study will be able to examine primary diagnostic and medical data in real time
o first-hand exposure reports are more reliable than second-hand or reconstructed Infonnation
e State-owned databases document worker histories
Uniqueness ofShanghai Study
G Robust data set
~ State-maintained benzene exposure and health effects databases docUmented from 19705
~ Benzene related health effects are "In In reported chronic occupational health hazards in China In 2001 (SDu=-"dPulkHcoaIth)
" Large range of exposure levels from a variety of occupational sources
<> Regulatory authorities interest in improving benzene exposure regulation and enforcement
,i
Quality, Independent Science
.. All protocols revIeWed and approved by external Institutional Rev~w Boanls (IRS's) GaIIem .'" 01 human wbjeds m U.s. ;r,d OIIna Independentjy
I) Shanghai Health Study independent review panels Intomallonal EIIlIes R.vtew PollOi Internatlonal Sdendflc RevIew Panel lZ members 6 odentlflc disciplines
Involved dU11rQ enllle p-oject
jRedacted
HAZ-SHA-000280
2
Benzene Health Research Consortium
Organization
/'" 1 1 ____OVersight Commltt~
Tjlcai/Bud9et Commutation Recruitment Legal
SdentIIIC _ Panel EthICS RevIew PanEl
APCO
Shanghai Health Study
Study Partfcipants
P!lncipol.,,~ D<. _"' ...... u oI~""" _ e o n...
Df. 0It0 wong, ApplIed ~ ~
Colo............
_ _ _01'. Fut1U1,fvG.lnUn~
OI_Port/dponts: _-'5aooDIoI_
"_eon. . ,."~""Shongl1ol_.
Shlft9MI
00... _
....
-.5<1...........5Iooo1QI\Ij~-
Sho....1PltIloI:r_ to< Publl<
Shollghll PubIc HtoiIII\e.....
u" \10_.Intenol RftIew IIOOnIs COI>oOo.......
AIlS
Shanghai Health Study Study Time Une
Aug 01
3/4Q01 2002
3Q03 Aug 03 <iQ03 Aug 04 2007/8
Consortium Formed . l'I'otocols Reviewed
Lab constructed, eqUipped at Fudan; tedlRidans trained
Began accruing cases Rrst Annual Meeting Opening Ceremony In Shanghai
Second. Annual Meeting
Report
Shanghai Health Study"
Redacted
Shanghai Health Study Summary
.. ~ Ix> obtain better undentilncllr.g 01 the med1anlsm 01 beNI!ne Induca:l disease In huma05.
.. Significant Imp;><1 DO benzene ns!< ~
.~:
~ stallHJl-lhe-art biological .00 epidemiological 5deIlIE repre;en\ $OU1d produ:t stewardship ~Ify best ~es In oesoord1 ethlcs cIep<nIl4)OI1 par1net>hlp 01 Industry, 11"""",",",,15, ac;odemla
.00 P\bIIt
HAZ-SHA-000281
3
. The Shanghai Health Study
Patsy Cle<]g
0.... ~ Canmla:
SI'IOIl~ll'
May 2004
What is the Shanghai Health Study?
II AIong-tenn dinical study to investigate the potential
ClIIl5eS and development of lympOO-hematopole1ic diseases (d"wease5 of the lymphoid organs, blQod and bone marrow) as rel~ to beraene
o A, projea of FuOiIIl University MedICilI Center; . UnlversltV of Colorado I-IeaIth ScIences Center;
Applied Health Stiences - an mdepeOOent U.S, research firm; O1inese public health agenCies; and Shanghai hospll:als
Benefits to Industry
~ set sciencebased standards to protect
workers and general population from benzene-induced disease
~ Mobile source air taxies standards a Water quality standards I'l Site remediation clean-up standards 10 Corporate responsibility and product
stewardship
Shanghai Health Study Purpose
eTo gain a quantifiable understanding of the relationship between benzene exposure and potential associated cancer risks
Path to developing the study:
"Pre-97: " 97:
" !l6-OO: .. 01:
.. 01:
- -~ene ~ assodaled woth AMl
NO ~~ fnlm Oil'lll SUJdy IIlat:
-~t.bttQURNHl
AHl~.t~~tINtI-~~ .. m
FNoOastM>ieIlItIyIo_:loIo!1f
CJ1Ild7ed In Shanghill
~n InstlWte 01 Pe!roIeum's (AlP) H...I\)l~SNcIy
....-_-It" -~-""'
............... wIlI""L.. _..,..,....
-_._<l_""",_MCl_-dO._"'....Benzene11eat111 Reseilrcn ConSQl1lum lCmted 11): ~
Benzene eKQOsure ~nd cancer Conclusions from pre-J997 Epidemiology
o Only acute myelogenous leukemia (AML)
a~iated with benzene
.
" No risk at exposures < 1 ppm :: Oear risk at exposures > 20 ppm
:I tosulfident datil at 1-20 ppm to assess risk
HAZ-SHA-000279
1
The Shanghai Health Study
case1. (min!! 5~
TIiIdItIcna~ ~"pIdemIoIogy stue!y II> determine
"51< of AML, NHL arncno benzene exposed wori<ers
: 450 AHL and 450 NHL pabI!nIS Inlo stLdy
2. DkrW /'rog!!:Wro Stud\!
Pn>speclNe m.dy 011 reialion5l11p ril1DlH3NZr booe manow disease ancl benzonelndua!d AHL
-... . .. ..... c". . , .. ..~:~t".l:'~;. . .,-,'I.'!.-,I.\l1r!r>
;.."...'""''cl-'";.'it'.;:';~-~.,'V.,,.~.. . .";A.
:\
toio,
,
., ~. 0:'.
',... '
. . . '.......
!.
': .,
Uniqueness ofShanghai Study
0'o prospective research Patients at participating hospitals suspec;ted having iI lymphOid, blood or bone marrow disease wlU be referred to the SHS
c Patients' diets, environmental exposures and !amity histories wlU be recorded
~ Patient disease progression followed at
supporting hospitals
_ ....~fJJ~m~~~W': _ ~f.~'v.'~~h~~~f4~:]i
Uniqueness ofShanghai Study
c Study will be able to examine primary diagnostic and medical data in real time
o First-hand exposure reports are more reliable than second-hand or reconstructed Infonnation
D State-owned databases document worker histories
Uniqueness ofShanghai Study
o Robust data set
z State-maintained benzene exposure and health effects databases documented from 1970s
" Benzene related health effects are 112 In
reported chroniC occupational health hazards in Olina in 200 1 (Sou= MJntstry d Putk Heollh)
" Larg e range of exposure levelS from a variety of
occupational SOUrtes
.
o Regulatory authorities interest in improving
benzene exposure regulation and
enforcement
Quality, Independent Science
Q All protocols revIeWed and approved by external Inst1tutional ReVieW Boards (IRS's) _ use of human SlJbjocIs " U.s. a'ld Ollna Inde\lUldently
" Shangnal Health Study independent review panels Intemiltlonal Etnlcs R _ Ponel 1_1lona1 StlenUIic RevIeW Pone! 12 members 6 soentlllc dlsdplines e InwM<i during ,,"lin! project
jRedacted
HAZ-SHA-000280
2
Benzene Health Research Consortium Organization
/ 1OVersight Comml~ 1 _____ TjlcallBud9et Commutcation Recnlltment Legal
SCIentific RevIew Panel APeO EthICS _ Panel
APJ Administrative Support
Shanghai Health Study
Study partldpants Prindpol~ DDoo..__Wn.l...-. _'U"~.."..".."..S..c..."..""Cen'"
OoIIobora.,.,
or, Fu H&a,. F\IdI,. UntcsKy _ __
_S<ftllalrI_au-Portidponts: ......... 5'_..,_ "_",,,,I<:< _ _S16IIi._....._..nQ_NI'-~
5ShIoOIOoh_Ol'"'*h_~_I.<..:...<. "''''''_s.~
Shanghai Health Study Study Time Une
Aug 01 3/4QOl 2002
3Q03 Aug 03 4Q03 Aug 04 2007/8
Consortium Formed Protocols Reviewed Lab constructed, eqUipped at Fudanj tedlnldans trained B4)gan ilCOlllng cases Arst Annual Meeting Opentng Ceremony In Shanghai second Annual Meeting Report
Shanghai Health Study
Redacted
Shanghai Health Study
,j
.~ Summary
o ~ 10 ctllaIn beIIer unders1ardlng ~ the medlanlsm of benzene Induced ell_51: 10 humans.
a Signl/lcant Impact on benzene risk ;'5secs[DPOl HIgbes! Duality <t Sd!m::
employ st!\IHlI-Ihe-art bIoIaglcilland epldemldlo!/b' sderu ~t 5Ot.fld product mwardShlp
~ txemIlIlfy best p1Ittices In researd1 eIhI<:s depend upon partner>hlp 01 Industry, govemmenlS, ~Io
ond public
HAZ-SHA-000281
3
The Shanghai Health Study
Patsy Clegg Ololr, ~I Ceo",,""'''
Shell Q-emIcaIs, I.P
May 2004
What is the Shanghai Health Study?
e A long-term dlnical study to investigate the potential
causes and deVelopment of lympho-hemiltopoIeIic
diseases (OISease5 of tile lymphoid Df9a1lS, blood and bone marrow) as related to benzene
o A project or Fudan University Medical Center; UniversitY of CoIorildo Health Sdences Centl!r; Applied Health SCIences - an independent U.S. r\!$!!art:h firm; Chin\!$!! public health agencies; and Shanghai hospitals
Benefits to Industry
~ Set science-based standards to protect
workers and general population from benzene-Induced disease
~ Mobile source air taxies standards II Water quality standards I': Site remediation dean-up standards
10 Corporate responsibility and product stewardship
Shanghai Health Study Purpose
eTo gain a quantifiable understanding of the"relatlonshlp between benzene exposure and potential associated cancer risks
Path to developing the study:
p Pre-97: .. 97:
" 98-00: .. 01:
" 01:
- -Benzene """"""'" associated WIlli AML
NO ~ mndU$lQnS from 01108 5IuIty 1Ilat: -- ' 1AJeNH'ente~_" c.a.u.s.e.H.I.1.I.... _ ..... _ _ c .,.
NO MeIl'ol<llo!1r' CIIIIdled
"----..fea5li;lllllysludleslll5/l;l1gllal
~Ilan InstilU!e 01 PeIroIe!Jm'$ (All')
Ileaill> Walch StudY
--.,-~
- ... _ _ _ NHl ... """""'..,.....
---"'--'''''-IIeru8!le_ill> -.:IICMsoriIUm ftlrmod!D;
-110 ....,"' .... _
Benzene exposure and cancer Conclusions from pre-1997 Epidemiology
C Only acute myelogenous leukemia (AML) associated with benzene
No risk at exposures <: 1 ppm " Dear risk at eKPOSUres > 20 ppm ~ (nsufficient data at 1-20 ppm to assess risk
HAZ-SHA-000279
J_ .
The Shanghai Health Study
I. a... em"", SIu!W Tradlllonill, prv:;pectIve epidemiology study to detennlne rlsk d AML, HHl.mcng ~ ~-'<...
450 AMl and 450 NHl pIIIlenlS Into stLdy
2. DI<ease """""""'" study
~bone marnSrwIl.d_y M
relationship d and beN...
.IIIOnIcHIu3la1CdeAI"MI.
Uniqueness ofShanghai Study
c prospective research " Patients at participating hospitals suspected of . having a lymphoid, blood or bone marrow dISease wi. be referred to the SHS
= Pallents' diets, environmental exposures and family histories will be recorded " Patient disease progression fonowed at
supporting hospitals
Uniqueness ofShanghai Study
c Study will be able to examine primary diagnOstic and medical data in real time
o First-hand exposure reports are more
reliable than second-hand or reconstructed
Infonnation
.
OJ State-owned databases document worker histories
Uniqueness ofShanghai Study
o Robust data set
z State-maintained benzene exposure and health effects databases documented from 19705
~ BellZene related health effects are 112 In
reported chronic occupational health hazards in
China In 2001 (SD<Jtrz:~dPutic_lh)
~ liIrge range of exposure levels from a vartety of
occupational SOUrtes
'
o Regulatory authorities interest in Improving
benzene exposure regulation and
enforcement
Quality, Independent Science
o All protocols revlewed and approved by external InstitUtional Review Boards (IRS's) G<M!rn use at human subjeds us. rod Olinalrodepenclallly
D Shanghai Health Study independent review panels Intl:mallonal EItlIcs Ii....... Pond Inrematlanal Sdentiflc RevIew Pond 12 memberl 6 5Qen1lt\c dlsdpllnes " Involved cIurIng ..,tIn! projeCt
jRedacted
HAZ-SHA-000280
2
Benzene Health Research Consortium Organization
OVersight Commltt~ / , 1 _____
. I"11ca1/Bud9et Communication Recruitment Legal
Sdenllllc ,'\""""" Panel Ethics RevIew Panel
APeO
Shanghai Health Study
"'nd" Study PartidDants Jn~ c.. _ ........ u" ' _ ....'" ScJonas eon...
1131""""eo...........:
0Dr... .ru ,Hu., F.vd.,iIn ,u,~- - - -
__
_ScIIoot._Dlr-Portidl*ll5! ......, ...
" " a . . . _s.._l i ......._ ' - .
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Shanghai Health Study Study lime Une
Aug 01 3/4QOl 2002
3Q03
Aug 03 4Q03 Aug 0'1 2007/8
Consortium Fonned
Protocols Reviewed lab constructed, equipped at Fudanj tedlnJdans trained Began acOlJlng cases
FIrst Annual Meeting Opening Ceremooy In Shanghai
Second Annual Meeting
Report
Shanghai Health Study
~
Redacted
Shanghai Health Study
Summary
.. ~ to obtain belter undestandlng 01 the mechanism of benzene Indlla!d disease In humans.
.. Sigl>fbnll/npod on bwuene d!k MSf'imJ'lll.
.~~:
employ stI_ _art bIoIagklll arid epidemiological Sdence
" repeent 50ISld prWur;t stEwllrdshlp " e><eI11lIlfy best IQctkeS In rese;.rtil ethic; depen,1upon parmer.nlp 0( Industry, gQ\'emments, acaIemla
_I'd publIC
HAZ-SHA-000281
3