Document 3QwXYe7jXXOv4emZj8J47nOn6

To: Baruch Brody (E-mail) <bbrody@bcm.tmc.edu>; Carol Fairbrother (E-mail) <carol.a.fairbrother@exxon.com>; cclark1 @tosco.com <cclark1 @tosco.com>; Craig M. Parker Ph. D. (E-mail) <cmparker@mapllc.com>; Dave Steup (E-mail) <drsteup@equiva.com>; Donald Burnett (E-mail) <burnetdm@bp.com>; f-judy.elledge@usa.conoco.com d-judy.elledge@usa.conoco.com>; jdps@chevron.com <jdps@chevron.com>; Lorraine Twerdok <twerdokl@api.org>; Lynn Russo (E-mail) <Iynn.b.russo@exxon.com>; Myron. C. Harrison (E-mail)<myron.c.harrison@exxon.com>; myron.c.harrison@exxon.com <myron.c.harrison@exxon.com>; Nancy Newkirk <newkirkn@api.org>; Norm Zeiser (E-mail) <ncze@chevron.com>; Otto Wong (E-mail) <OttoWong@aol.com>; Patrick Beatty (E-mail) <pwbe@chevron.com>; Patsy Clegg (E-mail) <pmclegg@shellus.com>; Rich Herold (E-mail) <heroldra@bp.com>; Richard Irons (E-mail) <richard.irons@uchsc.edu>; Robert Schnatter Ph. D. (E-mail) <arschna@fpe.erenj.com>; roythorc@bp.com <roythorc@bp.com>; Stuart Cagen (E-mail) <Szcagen@shellus.com>; Susan Hahn <hahns@api.org>; Thomas Armstrong (E-mail)<twarmst@erenj.com>; Tony Clarke-Sturman (E-mail) <Tony.A.Clarke-Sturman@OPC.shell.com>; William E. Maseth Jr. (E-mail) <masethwe@ bp. com> From: George Woodall <Woodallg@api.org> Cc: Bcc: Received Date: 2001-02-1920:54: 17 GMT Subject: Updated Q&A Document Benzene Consortium Stakeholders; I inadvertently sent an earlier version of the Q&A document than intended on Friday. Attached, please find the latest draft. Please discard the earlier version. Again, my apologies for any confusion. Regards, George M. Woodall, Ph.D. Senior Toxicologist American Petroleum Institute 1220 L Street, NW Washington, DC 20005 tel: (202) 682-8067 fax: (202) 682-8031 woodallg @api.org Attachments: ConsortiumQA Rev.doc SHELL-MCCLURG-055071 Q&A Studies of Benzene in China Page 1 The purpose of this document is to outline the answers to the questions most frequently asked regarding these studies. Glossary of Terms AML (Acute Myelogenous Leukemia): The hematopoietic cancer most commonly associated with exposure to benzene. Hematopoiesis: The formation of blood and blood cells, including red & white blood cells and platelets. NHL (Non-Hodgkins Lymphoma): Complex spectrum of malignancies of lymphoid tissues, most often arising in the lymph nodes. NCIICAPM (National Cancer Institue/Chinese Academy of Preventative Medicine) - The authors of a previous set of studies in China that found NHL associated with benzene exposure, the first study to show such a linkage. SMCDC (Shanghai Municipal Centers for Disease Control) - The Shanghai governmental agency responsible for occupational exposure monitoring and enforcement "Q. For the Case Contr~(S./t.ud(o/f//~HL/,/W/ ~J)./ f.//.~. \\ techniques. A number of viral infections are just perform a retro~ective study;/w6QWthat /'. \known risk factors for some forms of NHL. For / Inot be a quicker and n1Qch les_~_.exPenve wro:) to get the same informatfonr- // ~-~./ ~xample, hepatitis C which is common in China. The presence of the planned laboratory on site in . / .A // //) _/ Sha/I]~i assures us of consistent, state-of-the-art A. First and foremost, is the lack'uf ooIllple'te auer--- .-ilia-gnostic capabilities under our control without verifiable study. A ndUiIa?gbn~orseosf ofr~ohm~r acosnidm~t?I~oen(yc6asnp.em;0!:?Je0~~/ /_ //./<;~h~egnhet.~a~rieteynto~~Itlheed.mlogSih~ItPi?cm.agndhbuumreaanu~tIrsastuiec NH~, ~nd mIsd~agnosI~ IS easy m the'a!2~nce ~f ~// sa pIes ~..xJ{e 'U~ for testmg. sophIstIcated dIagnostIc procedures. ~g~08tIc . .' / '''. samples are not routin~ly kept i~ Chi~a aIrcf th~"/~7Jj~iiev}:~at the"~~I/CAPM study finding of would be no opportumty to confIrm diagnoses// /mcrease~ nsk~~b.~n b~nzene expose? for most cases. Secondly, assessment of \. / / / wO"rfers I~.~ue t9.unrecogmzed confoundmg exposure and confounding risk factors is \... ( .%ctci'rs. We do ll'Qt want fu repeat their mistake. complicated in ~ retrospe~tive s~udy. In the case \ v// \../ . /). <"'\. of deceased patIents, details of lIfestyle and work Q. Why are we..l'I{cl~~Hg AMI:; III the Case- history must be obtained from relatives or other Contro~dY...fiML is~o in the Disease workers. Taking cases prospectively reduces the Prowession~udy. Isn't this a duplication? distance in time that one needs to go back in order to get needed exposure records. (. // A. Inc~q.itlg AML, which we would expect to see associated with benzene exposure, provides a Q. The diagnostic laboratory is a major expense. positive control to defend against criticisms that Why is it necessary? Why can't we just do a our methodology was somehow not adequate to standard case-control study? see associations that do exist. There is some overlap in that the Case-Control study will serve A. Non Hodgkin's Lymphoma (NHL) is an as one source of AML cases in the Disease aggregate category of ca. 20 distinct lymphocytic Progression study. diseases. In order to perform an NHL study that conforms with the current diagnostic schema, the subtype of NHL should be known. These subtypes are distinguished by morphological appearance and characterization of cell surface markers by sophisticated immunochemical February 16. 200 J SH ELL-MCCLU RG-055072 Q&A Studies of Benzene in China Page 2 Q. One of the reasons for pursuing the Molecular which would complicate obtaining large numbers Epidemiology study is that the Chinese of participants. officials in Shanghai have requested this type Bioethics - Providing this higher level of of data; why can't they use the existing diagnostic information to hospital physicians NCIICAPM study results? improves the level of patient care which fulfills the ethical requirement that the study benefit The NCI/CAPM study was roundly criticized for participants and the general community in which not providing a good measure of actual exposure; the research is performed. for not accounting for exposures to multiple chemicals; for assuming that all AML, NHL, and Q. If the Chinese are going to be the major other blood-related diseases were causedJ;>, exposure to benzene alone; and with l?p6r stll~y beneficiaries of this research, shouldn't they contribute to the project? design that did not account for con,Wunding '\ factors (e.g, smoking) and otht:<pfact0;:S:1JSEPi\ A. Although the Chinese are not providing direct has taken the position that t~stu,9:y'cant be/monetary contributions, they will be contributing used to calculate a qua9tit~ive,.ctincepi~k fr91TI /~\ in-kind support. The laboratory space allocated benzene exposure. 1Jiis is pr.cis~the re/sop./ \\ to the project has been provided by Fudan this study will be so hhportant:-/ / / / / /', \University. The funds provided by API for the / IThe Chinese base their o'\c'~.upaiior_yt/f/'.st/a/nd//\ards/~//) Vaboratory space have gone toward renovation of that space to make it acceptable for the purposes measurable effects on people, ,9-ml notprt) _,/ of t!!-is--~udy, but we will not pay any rent for the mathematical modeling of hyp'6the}ital,ri'sks <fsTs-- /.MSe of th'e space during the period of our studies. typi~al i~ the U.S. a?d Europe.. 'The l)TCI/C/A'PM ~/ // Tj)e ~oys'1i derable resour~es of the Shanghai studIes dId not rovide them wIth t t e/of a /o'/Muni al Ce ters for DIsease Control u on which to ~ase a chan e in th~ir btl ;enf ~// S CDC .Kave..,been of~ered. freel : ~~cluding standards. TheIr current standard IS bas~d O}1~ se of theIr datab3.$e to IdentIfy facIlItIes and decreas~ in white bl?od cell c~unts rather'fhan >,,/in~widualfr~ inclu'ciy i~ the st~dy as .well as leukemIa. They are mterested m the Moleculay/ /Uiborato~ sup.I?~~.-<.ndustnal hygIene Epide.mi~logy Study whi~h i~ intended. to proVi.de/.// m..9.1\itor~n~analySes n~c'e,ssary to.the study. And an obJectIve, measurable mdicator of nsk. ' ( ..most~jn(edly, ill) Chme's'e,provide access to the \., / / subjects, withouvwhom it wb~ld be impossible to Q. Why are we taking on the expense of providing laboratory diagnostic services for hematopoietic diseases in Shanghai hospitals conduct sucMstu'!YA., // // ./ \,./ / ./ Q. Whl/iS this,biing undertaken primarily by the during the course of the study? pefroleu.m1ndustry, and why have other ind'nstfies and/or international companies not A. These services provide crucial benefits to the been approached to help fund this research? consortium research in two areas: Research Data - As the central diagnostic A. API has played a lead role in getting this study laboratory we will assure the quality and underway, because the petroleum industry has a consistency of the diagnostic data. This role major interest in better understanding risks to assures access to blood and bone marrow human health due to benzene exposure. Other samples from study participants. Without this industries are being approached to help in this role we would have to seek permission to effort, as are international petroleum companies perform a second procedure to obtain these and trade associations. Presentations have been tissues for the research. Patients would be made to CONCAWE, IPIECA, and CEFIe. At reluctant to undergo such a second procedure, least one of our major supporters, BP, is headquartered outside the United States. For more information contact: Lorraine Twerdok (API) at (202)682-8344 or twerdokl@api.org; or Patrick Beatty (Chevron) at (510)242-7037 or pVlbe@chevron.com February 16. 200 J SH ELL-MCCLU RG-055073