Document Jrw1gjEgrXob55zE98V6xBm7K

Proposed China Consortium Corrunittee Strucrure For Presentation at August 31, 2000 Coosortilllll Development Meering The foUowing is intended as a draft deScription ofthe major duties, roles and makeup of committees that could function as the admiil.istrarive, scientific, and ethics oversight components of the China Benzene Resean:h Consortium.. This draft is intended for discussion only. and does nol represent the final, or recommended committee suuc:ture or rAAPonsibilitlcs. Plc:lISe sec lhe attached flow chart for a schematic of the reportinf relationships ofthc t:CII:nmittees descnDed below. COMMITTEES Business Ovenlgbt Committee Membership: One member from each sponsor company. The Chainnan of the Technion! Oversight Commlttee is e:f' officio member oftbis corrunittee, non-Voting unless also designated as full member ofUUs committc:c. Input; The Busineas Oversight Commiltee receives input from the Technical Oversight Committee regarding the: technical progress ofthe research and recommendations for research related expenditures, and froro the Ethics Revicw Board regarding recommeodaliOllS for bioctbics rela.ted issues. Responsibilities; The Business Oversight Committee shall be the ultimate administratiVl.l authority Cor the consortium and shall make all fiIUlI decisions regarding budget, .reporting and interaction with the Chinese authorities. The Business Oversight Committee shall have final approval OVer the membership of the Elhies Review Board and over th~ membership of the Scientific Review Board subsequent to the recOmlneodation ofthe Technical Oversight Committee. The Business Oversight Comnriltee shall report Annually to the member companies on the financial SlalnS of the consortium. All expenditures of the consortium shall be approved or delegated by the Business Oversighl Committee. The Business Oversight Ccwmiltee shall be responsible for TSCA 8(e) reporting on benalf ofthc consortiwn. TIlls role in no way limits the ability ofindivitlual members of the consomwn from filing individual &(e) submissions iCthey deem it appropriate. MOC00044969 Technical Oversight Committee Membership: 'The membersrup of the Technical Oversight Committee shall include one member from each contributing memberofthe consortium. (OulSide entities such as governmental agencies or NGOs could have a place on this comminee subject to approval ofthe Business Oversight Committee.) . Im:mt The Technical Oversight Committee shall receive semiannual reports from the principal invcsUgalors regarding the progress ofresearch. This committee shall also receive reports from any Quality AssUI'llIlce activities WIden liken during the course of the research. This committee would receive recommendations from both the Ethics Review Board and the Scientific Review Board regarding Lhe conduct ofresearcb and. in the case orlhc laUcr board, the aocc:ptabihry ofproposed manuscripts and abStracts. Responsibilities: The Technical Oversight Conu:nittee shall act as the technical consultant to the Business Oversight Committee cfthe consortium. This committee would review all manuscripts for pUbliootion and abstracts ofpresentations stemming from the consortium researcb and advise the Business Oversight Committee an the validity and interpretation nusof 'the results received from the principal investigators. committee sball he responsible for recommending protocol a1tlmltions, abstracts ofpn:sentations and mWlll$cripts for publication to the Scientific RJ:view Board for approval. . Scielltifie Review Board: Membership: lntern.ationaily recognized experts in scientifichnedical fields that are recommended by the Technical Oversight Committee and approved by the BusineSs Oversight Ccmunitl:ee. 'There are also potential sealS on the Co,mmittee for other . stakeholders as approvc:d by the Business Oversight Committee. The chair ofthe Ethici Review Board shalllliso be a member ex offic:ic of the Scientific Review Board. .l!:!ru!t The Scientific Review Board shall receive progress reports from the principal investigators onat least a semi-annual basis. The Scientific Review Board shall meet annually to receive It report from the Principal investigators on !he progress oftbe research relative to the proposed protocols... Otherwise, the Scientific Review Board shall meet in person or by conferencecall as deemed necessary to carry out their duties. The Scientific Review Board shall consult with Ihe Ethics Review Board regarding the ethical conduct of research under this program. . Responsloilities; ]( shaU be the responsibility of the Scientific Review Board (0 approve the initial research protocol and all significant protocol changes thereafter. The Scientific Review Board based upon the decision ofthe chair af that group shall determine what protocol changes are considered significant These approvals shall be transmitted via the Technical Oversight Committee 10 the Business Oversight Committee for [mal acceptanJ:e. The Scientific Review Board shall approve all manuscripts for publications and all abst:l:llCts for presentation by whatever mwium that inclUde data gene!1l\ed as part ofthis research projec:L MOCOOD44970 Ethics Review Board: Membershlp; Determined by the Business Oversight Committee. This. Board showd include at least one recognized bioethicist from the United Stales, The European Union and the Proples Republic ofChina. This board should also include one or more representatives of the community under study. The Chair of the Scientific Review Board shall be an ex officio member oflhe Ethics Review Board. Input: The Ethics Oversight Board will receive inpul from the Technical Oversight Coromittee and the principal investigators regarding proposed research and from the NGO Liaison Committee regarding actions to address bioelhics issues raised by this research. Responsibilities; The Ethics Review Board shall be responsible for n:commem' ;ng nIl actions by the consortium that are intended 10 ensure that all research performed by the Consortium shall conform to ethical standards as identified by the Ethics Review Boord and approved by the Business oversight Committee. The Ethics Committee shall maintain close communication with the Scientific Oversight Committee to ensur~ that the implementwon of aU research protocols isconsistenl with ethical standards as dermed above. To this end the Ethies Review Board shall meet Armllally 10 review fhe progress of research and to assure itselfthat the resc::an:h is being conducted in a manner consistent with the approv~d ethical guidelipes. NGO Liaison Committee: Membership: At II. minimum the membership ofthe Non-Governmental Liaison Committee (NGO Liaison Committee) shall consist ofII. member of the Business and Tecbnicirl Oversight Committees, a member of the EUrics Review Board and a member of each outside agency with which the Consortium is affiliated. Reswnsibilities: !be NGO Liaison Committee shall exist for the purpose ofaddressing biocthical issues raised by the research program of the Cons()rtium tha.t can met by collaboration, with entities other than governmental regulatory bodies or industry associations. The NGO Liaison Committee shall recommend p.ognuns and a budget to the Business Oversight Committee to address these issues. ~ The NGO Liaison Comminee shall consult with the Ethics Review Board regarding P'(Ogr.uns to address bioethics issues. MOC00044971 Proposed Studies on the Risk of Pase IBenzenew Induced Diseases in China Goal: To fonn II consortium 10 fund rescnrch an be:nzenf-exposed workers in China. !1Page -l!1i"_ ",1JatI:.t~ddbU1t . fJoP4",""*_.lIJOI .h_""""'..... . \MOt- - MlIIINRI c;orQd \I Unique, vnparallellHl resean:b opplll1Un/6es Purpose: To gain an accurute understanding of the true relationship between benzene exposure and the risk Dr disease. Thi~ study would lead to improved bellZCl1....drivm. hl:llith-based regulatory standards by providioil the regulatory and scil:l1tifio communities with informauan fOT mere accurate asscssm(;Ut efthe risks from exposure to bcnl!!:llc. Opport!lnities:: A unique set of opportunities I:JUsts al Ibis point in time in Shl1nghai 10 conduct meaningful bcn=c r=atcb, includillll high occupational I:XpOSUIeS that do not e~ist anyw!=c in fue West, willing co-investigator, influential in local scientific, medical, atld n:gulatory establishments. Therefore, questions that have plagued nnd confounded benzene health risk asscssment for decack.s appear to he answeruble in Shanghai. . Cballeng~: The proposed studies mfct scvetlll technical, ethical, and culruroUpoJitieal challenges .!. Technical - In order 10 stand up to sCientific. scru~llY, studies must be large, well-managed, and inc;orporale the latest technology. Stlte-of-thc.art res.earth is absolutely ncccsury to make real progress in ohanging the existing herru:ne risk assessment paradigm.. ! Ethi9!\- To address Ihe ethical issues. the study pmtocols have all undergone a thorough analysis to ensure thnt the subjects are appropriately eompCIl5atcd for their partiCipation; that both the: subjects and communities benefit from having participated in the: study; and that worker safety will improve. An Ethic$ Panel is part ofthe oversight for the project and includes II Chinese bioethicist. ! CulturallPolitical In order to address the rc:alitias of domg research in China, collabOOllors on these studies includa researchers from the Medical Scbooilit Fud1lI\ University. the Shanghai Municipal CClltcrs for Disease Control (=ponsiblc: for occupatioITllI exposure monitoriug and enfDrcement). :IIlli11001 MOC00044972 .....- . _ - - - - _...- - - - - - - Proposed Studies on the Risk of Pag.,:ZBenzene-lnduced Diseases in Cbina Benefits of E:JCtenslve Collaboration CH;NSsE PlEFlSPEiCnVE enh,."c_ P"WIIf_"'onai Ad"'....ftIl:.... .. PuOlI-=-u"n_ ---...._ ~.,qUircUlg Hwri"..", tr.OC;kr~mca' ,,O" e.J~.!:I"'il.kt'qu_. ",. .h;:.I,,,.. r:;:rw,.nc" 'Au""'trnp~R.'~~ .rnp,..a\ll1ll'C" ~I__"""'.g"_"ry "'.f'NI.e. tn C:""n_ . Page 21 Benefits: InfDmllltion gained from Ibis prqj ect win have II dir~t, CToss-media impact upon rc:gwalory stanLlnrds designed to proteci workers WId the llenerol population from benzene-induced dl$ease. These include air and water quality standards, lIS wen as hazllrdou$ waste nnd site remediation standnrds. The information gained from these studies will assist contributing companies in achieving producl stcWlll'dship goals and will be useful in defending the industry's risk reduction programs. Additional benefits from this collahanlive approach are outlined below. Vl!\1tQOI ---- '- MOC00044973 .--. -- ._--------- Proposed Studies on the Risk 01 Plg~3Benzene-Induced Diseases in Cbina The Studies: 11t.rec: inter-related studles have betn proposed for this project: S~j hn.tellc Study S1nJ<;lur. Pagel} Cuse-Cantral Stlldy - A hospiml-based case control srudy to investigate the potential rclwotlship between b=c: exposure a.nd both Non- . Hodgkins Lympboma (Nm.) md Acute Myelogenous Leuk=i9 (AML), including an attempt to quantify the potency ofberu:.cne for the AML response, Disell.5 l"rogrl!!5lull Study - A hospital/clinte-based iovcost1sation of the relationship between non cancer disease> of the bone marrow and AML (cancer) to determine if effects on bone marrow progress through non-canccr Stlgt:S to an ultimate leukemia. This study would also attempt to define the sb:1pe of the dose response rDT these "precursor" diseases !lIld could result in chllractcri:Z:lltion of unique identifie.r.! ofbe:nu:m:-induccd AML. Molecular EpIdemiology Study - lnVc.stigale if there is a qunnlitativc relationship betwee:" benzene l:1Cpomrc: and pOlential early indicatorS of both I!JO;posure and effec.t ill a focused population of benzlmc exposed w o r k e r s . Total Cost E5timll~e (lOOl U.S. Dollars) , Seed Monies S5OO,000 SrudyCosts ClISc-Co:tlll'ol SPldy Disease Progn:ssiou SIlldy Molecular Epidemlolagy Stlldy . $1,161,000 $3.494,000 $3,175,000 H=lologica\ Laboratory in Shanghai $8,340,000 External CommunicaliDllll 51,000,000 Olhcr Costs {Admi:J:li.$ttarive, Travel, Ethics Panel, SclClltifu: Dvenight Panel} I$\,341,000 GRANnTOTAL 519,71.3,1l00 Cosh; The estimated costs for the project were derived aft~r clireflll consideration of aU of the. technical, ethical, and political issues. Therefore, the estimale& CDsls are fairly stable and are not anticipated ttl 1I16l.!OOI MOC00044974 Proposed Studies OD the Risk of Page4Benzene-Induced Diseases in China increase by much (inflation has been jncorPorat,:d into the estimate), 41Page Funding: Funding fot !he project will be l)andled by II consortium of interested slakehnlders, with shares determined by size of the rontn'buting organization. The proposed funding fonnula was devised based on !.be assumptioo that mest of the support will com!: from Ille petroleum and petrochemical industrieli, It is anticipated to lake five: year;; 10 complete the project, and thnt Ilte costs Wlll be highest in the lirstYClIt$ Githe project Example Fuuding for ODe Shan: By Project Year* I Stuily Year Percent of Costs CoS( Per Shan: I 30 $421..4DO 2 15 S3S2,OIlO 3 IS Slll,200 4 15 5211,200 f5 15 S211.200 I Total: $1,408,000 "Assumes wt!hen: arc A IOtal of 14.;bares at app",=arely $1.408.000 per lIhnre. Coatt per shaIl> 1lllIy increase or de~ (i.e., total nmnbcr of sha"), 'Proposed Funding Formula Share Determiuatioll SbarebDld~r Category U.s. Refiner (burd on u.s. nd,n,,>, <;III'''ty)" _11 IS: soo,ooo bhll.n.y}. M.~i~m (>500,000..., s 1,51)0.000 bWd..Y~ Urscf> 1$0,000 bbVdey) Vail-U.S. Rt:f= (no U.S. n:fme:r:ie$) FreeStanding Cbemiai Co, (No n:.Iillcrics) tJp!tn:arn Company (No renlli:rie~) Other (mode association, govc:m.mcnl. NGO) Shnres I 2 J I 2 ! Ncguti.hle U.S. n:inC!}' ","pllCllJ" wtU b. dct.::nn=d bed upon reflllery (lWDersbip 11 (If OClober 1.2000. Cap.city will be ca Journa.I', 2000 PcnnwcU Diredlll)'. Fill' more information cuntact: Lorraine Twerdok (API) at (202)682-8344 or twerdoklliilapLorg; or Patrick Beatty (Chevron) al (510)242-7037 or pWbe@cbeVTon.com 211tillOOl MOCOQ044975 ProRO"sed Studle:ifo,n thJl..lijsk ~r BeiJ,zene,.luoucedlDiiiease8,mCbjna Purpose: To gain lin acc\Il'iIle undemanding orthel:ruc reilltioruhip berw~n bcnttn.!: CltposuIl: and the risk or =in hcmalllpoietic diseases. This study would lead III improved benune-drivcn, h~althbase.d regulatcry (e.g.. ambienl air, waler &. DCCIJpational) standards worldwide, by pl'tlviding !he regubtary and sci"'lufic: communities with inf'ol'ltlilticn for IIlOre IICCUr.lIe ass=menl ofthe risks from exposure to benzcn.e. .l~~a . 'MII"~'" Ir.IlltdI ~ A unique set of circ:u.mslallce:s existS al this poim ill lime in Sbangha.! to ~onduc:t mr:mingful hl:nzene 1'CSCJ1n::b. T1u::s" include. II datnbaSe of occupati<m3l C)(posun:s in ~ differeD! regulatory environm=nl:, and willing ane! qwillfied co-inV..stiplOl3 influential in loc:al scientific medical. and n::gulatory establishmcn!S. Thercrore, q\lt:stion$ thai bave pl.gut:d bOf\:t.OIIC bc:alth Qsk lIS!:Cmnent for d.cad"" ..ppear to be answerable in Shan ~ai. I Uniq]le: llijparal~d .nfsearcl! opp;ai'!!lDllies :(ThDllcnf:i!s"I'The. proposed srudie:s meet several tedmicnl. e,thical. and culnml.lIpoliucal challenges. l'cgbuical In crdcr to stand up to .scientific Sl:I'Utiny, studies mU$.\ he: larce. wclknaaaged, .utd jncotpora1c Ibe latest technology. Slate-of-Ihc-an rescan::h 1s absDlutely nec~ to ~ real progren in dtve/opicg sound be:nzcm rilIk assessmf:l\ts. .El.l!iQ!. To addreu !he ethical issues. the study prolocols have a/l undergone Ik Ihorougb analYlis to en$ure that: the subjectund paniciplUing communities benefit from having parncipa!ed in the study; th:t confidentiality is preserved. and lbal researchers art: working with local regulatory Duthontics to improve workc:r wety. An Ethles Pand is pan of the ovelllig:ht for Ihe project and indudc:s a Chinae bioethicist. Culiuial1"llljricitF- In oroI:{' 10 address the rallities of doing =m;b III China, co!laOOralllrs 011 these siudies include researchers from the Medical School at Fudltn University, and Ihe ShttngIuU Murucipal Centers fur Disease Control and Prevention (responsible for occupational exJlOSun: lTulnitoring and mrllre~t). &elunm Information gained !tom this proje!:t will have a direel relevance for WOrldwide lCgularory standards designed 10 protect wockers and the ccuCl'llI populuion from llenune-inducr:d disease:. These include air and ~r quality standards, as well as lutz.ardllus Wa5.t~ aDd. ,ite nctrn:dialinll. .standa.rd&. Th_ swdies will 8!i!1ist contn'budng companies: in aehil'Ving product steWllJ'dship goals. Tn.,. SlutllC'1br~ inter-reialt:d studies have b= proposed for this project: C~O"'!~; ~tully A bQspital-bllSed case control lUdy to inv..tigate th" potenlial relll.tiCinsnip between b=l11: exposure and both Non-Hodgkins Lymphoma (NHL) and Acute MyelQgcnGUll Leulallnia (AML), iMluding an attempt to quanti IY the potency ofb=ne for tbe AML fe$ponse. f)L$,",I~ 'P"'Wi!sSfoD: Study II lmspitalltIinic-bl\!led investigation of the relatlClnship between IlOlH:iIocer diseases of th= bone marrow lind AML (caoc!!:c) to. determine ir effeds on bone marrow progress through oon-cancer stagC$ ID an ultimate leukemia. Thts srudy would also attempt to ordefine Ihe shap~ !he dose respOIlSe for possible "p~IUliQ"" disQ!il:S lind could rerull ill cll=!e~tion of unique identifiers nfb==ne-jnduc:cd AML ~fi1Il1+t!1lI1 i:!:p.IIl~dl!li.iro SUtlll' - Investigate if there is it quantitative relationship' berween benune ~Qsur" snd potentiill early indicators of bom exposure and effect in a fO(:US=d population ofworkers. ~ Rome.... Stildr Sl~ MOC00044976 orl"r.opo~edStudi,es D1I the Ri'k Benieue-Il1diIced Disease$ in China COltS: The C$UrnIltcd cosu for the projd Wl:re dcnved lifter careful consideration of all of the technical, ethical, and political is.su~. [inflation hu been incolpOllited into the estimate). $SOO,oolf $}j1?"l,RP.Q' '$3;494,.QOj)' ',S;f3;!5;1l0n S19113 000 Fl1ltd~c:: funding fpf tbe project will be hwdled by a consortium ofilllete$~d sta.l:eholders. with shares detetrnined by size of the blm%<nc related opentiorIJ of the contrlbulinl: orplli1llltion.. The proposed fund~ fOml\lla was devll>.a bllJlCd on the l!5!Iumption that most of the support will CDme from the petrolwltl sod pel:l:Dt:lwmical industrie:s.. [t is nnucipatc:d ID take: live years \I) complew the: projecl. and thAt the coslS will be highest in the fltSl yean ofthe project. PrO'POled "flmvill.C FOl'mulll Sblire Deti:rmlnatfolJ . , 'Shllrcbllldcr Calc On' _ U.S. Rbl'inc:r ~ou Q~. retmc:r.y'QIp!1City~ Sriulll {~.5OO,.oo(nl"lIt1liyl ' ~1llIf !UJ!l.~ I.,.,sOO,l\Q(i:bllllJlilyJ l3bltdil ) , ,Silor,t:!I 1 :t J, tnmple FUl\d\ur. {or Oile pli~'rQ" Bsy',Prejtct Y'C;ir* Shidv YilJl.r Pefcenlo'f,OlStS Cllst;Per Slinr'1t '1 31) is $ U .. 15 , $421;400 $l'~fXlij $iiI.l1Kl S2l.l,lOO 5 IS :WIY200 .Totlll:. $1.408: olio orAssume$ tIIa1 ttiere. are 2"IDtal 14 Shan::s at ~pprolClJna\l:ly $1.4011,000 per share. COstll per sban: may incn:asc 01 decllOUe dependent UpllD pnrtlciplluon lC1l~1 (i.e.. latlll number of~Iure.). Lorraine Twerdok {APtrat (202)6Bl"li344 or'lwerdokl@!Jpl-Drg; ot l'a!rlcl:. B'c3lry (Chevron) lit (5Ul}i4'2-7017 'or.l?,I,ibe@r:havron.cDm. Mocoa044977 Q&A Studies of Benzene in China The purpose oftbi!: document is to outline the lIl1Swers to the questions most frequentl)' llSked regarding these studies. Glossary of Terms AML (Acute Myelogenous Leukemia): The hematopoietic disease most commonly associated Willi exposure to beDZene~ This relationship bas resulted in benzene's classification as a human carcinogen. Hematopoiesig: The formaticm of blood and blood cells, including fed &: white blood cells and platelets . NUL (Non-Hodgkins Lymphoma): Complex spectnun of malignancies oflymphoid tissues, most often arising in the lymph nodes. NClICAPM (National Cancer Institue/Chiul!Se Academy or Preventative Medicine) - The autbors ofa previous set of studies in China that found NHL associated willl benzene exposure, the first study to show such a linkage. SMCDC (ShllDghai MUllicipal Centers fDr Disease: Control) - The Shanghai governmental agency responsible for occupational exposure monitoring and enrorcement Q. For the Case COlltrol Study dNHL, why Dct just perform a retrospective study; would that not be Ii quicker :aud much lc:s5 expensive way to get the same informatioa? A. First aad roremost. is the lack of complete and verifiable diagnoses from It simple re:trosp,ective study. A nUiriber of other t:onditions can mimic NHL. and misdiagnosis is easy in the absence of sophisticated diagnostic procedures. Diagnostic slImples an: not routinely kept in China and there would be no opportunity to confrrm dlagnoses for most case'&. Sc:condly, assessment of exposure Md Ctlnfounding risk factors is complicated in a ' retrospective study. In the case of deceased orpatients, dwiJls 'oflifes!ylo and wark history must bl:: obta.ined from relatives other workers. Taking cases prospectively reduces the distance in time that one needs to go back in order to gel ,needed exposure i~rd9. ' Q. The dia~nostic Iliboratory is: Ii major e:rpensl!. Wby is it necesSllry? Why eaq'twe just do a standard case-llonirol study? A. Non Hodgkin's Lymphoma (NHL) is an. aggregate category of ell. 20 distinct lymphocytic diseases. In order to perform an NHL study that conforms with the current diagnostic sclJema, tbe subtype ofNHL should be known. These sUbtypes are distinguished by morphological appearance and chamctenzal:ion of cell surface markers by sophisticated immunochemical lecbniques. A number of viTal infectiollli are: known risk factolS for some forms ofNHL. For example, hepatitis C which is common in China. ' The presence of the planned laboratory on site in Shanghai assures us of consistent, state-ofthe-art diagnostic capabilities undc( our conlIn! without the necessity of the logistic md bureaucratic nightmare entailed in shipping humllll tiS$Uc samples 10 the US for testing. Thus the laboratory is an essential and required feature of this program. Besides providing WliImm, state-of-the-art diagnoses, it provides the necessary teclmo\OID' to control for many potentially confounding factors (e.g., cell type, viral infections) that could affect the [1;:Ilults of this study. This will allow lIS to provide more iDSigbt OD the relationship. ifany, between benzene and NID.. than previous studies such as' the NCVCAPM study. Q. My arc we including AML in Che CaseCOlltrolstudy. AlW.. is also ill the Disease Progrl!$sion study. Isu't thill a duplication? A. fucluding AML, which we would expect to see associated with bemene exposure, provides a positive control to defend against criticisms that our metbodo\agywas somehow not adequate to see associations that do exist There is same overlap in thaI the Case-Control study will serve !!:.S1Ju;: sOurce of AMI. cases in the Disease Progression stut!!. MOC0004497B ."'---' ._--------- Q&A Studies or Benze.mi in China Pnge2 Q. One oftbe reasons for purliuiug the Mulecular EpidemiDlogy study Is that tbe Chinese officials in Shanghai have requested this type of data, why can't tlley use t'he ~xistiug NCUCAPM study resuJls7 The:: NCIlCAPM study was roundly criticized for not providing a good measure of actual exposure; for 110t accountingtor exposures to multiple chemicals; for llSUming tha.t all AMI.., NHL, and other blood-related diseases were caused by exposure to benzene alone; and with poor study design that did not account (or confounding factors (e.g, smoking) and other factors. USEPA has taken the position that this study cannal be used to calculate a guanti!ative cancer risk from benzene exposure. TIlls is precisely the reason this study will be so important The Chinese base their occupational standnrds on measurable effects on people,. and not on mathcnancal modeling ofhypolhetieal risks as is typical in the U.s. and Europe. The NCllCAPM studies did not !}fond!: them with the type ofdata unon which to base a change in their current standards. Their current standard is based on a decrease in white blood cell counts t'Ilther than leukemia. They arc interesled in the Molecular Epidemiology Study which is intended to provide an objective. measurable indicator ofrisk. Q. '\by are we taking 00 the expense (If pn)Viding laboratory diagnostic services for . . hematDpoietic diseases io Sbanghni hospitals during the course (If the study? . A. These seniccs provide crucial benefits to the consortium = = h in two areas: + Res=b Dala - As the central diagnostic laboratory we will assure the quality and consjS1eney oIthe diagnostic dati!. This role assure! aCcCSlito blood and bOlle marrow s~ from study participants. Without this TD Ie we would have to seek permission to perform a second procedure to obtain these tissues for the research. Patients would be reluctant to undo:rgo such a second procedure, which would compiicall: obtaining large numbers of participants. + Bioethics - Providing this higher level of diagnostic information to hospital physicians improves the level ofpatient care:: whlch addresses the erhics standllJ"d that the study benefit participants and the: gencntl Camrtlunity in which the research is perfonned. Q. Uthe Chinese are going 10 be tbe major benefidaries oftbis research, shouldn't tbey contribute to the p[1)Ject? .A. Although the Chinese are nat providing direct monetary contributions. they will be contributing inkind suppnrt. The laboratory space alloca.ted to lhe project has been provided by Fudan University. The funds provided by APl for the labomtory space have gone loward renovation of 'c' . thllt splice to mnke it lIcceptable for the purposes oftbis study, but we wiDllot pay any rent for the use ofthe space during the period of our studies. The cOllSidcrable resources oftbe Shanghai Municipal Centers for Di~ase Control (SMCDC) . have been offr::n:d freely. including I.\S(l oftheir database tD identify facilities and individuals to include in the study lIS well lIS laboratory support for industrial hygiene monitoring analyses necessary to the study. And most poilltedly~ Chinese orovide access 10 the slIbjects. without. whom it would be impossible to conduct such a litudy. Q. Why is tbis being undertaken primarily by th.\! petroleum indUstry, lind why have other industries andior illternlltional companies Dot been approacbed to help fllnd this research? A. API hns long taken a lead role iII benzene health effects research. Other industries are hem It . iU1prnached to help in this effort, as arc international petroleum companies and trude associations. Presentations have been made to ourCONCAWE, rPIECA, and CEFIC. At least one of major supponers, BP, is headquartered outside the United Slates. For &nOtC information I:ontlll:t; Lorraine Twerdok (API) at (202)682-8344 ortwgdolcl@api.org; or Patrick Beatty (Chevron) at (510)242-7037 or pwbe@chevron.com MOCOOO44979