Document GmwLB3LByJE2rzKdjZ3p1OJYq

t MCraig Park~r ~ OnePager.doc =Proposed Studies on the Risk of Page lBenzene-Induced Diseases in China Goa); To form a consortium to fund resenrch on benzene-exposed workers in China. Page 11 HI9h upcsuru Bw~ddbrast Good monl:nllll:.1J1Cb 1940's Exposures \ ltcMolo;f;opl\lllleltkl~ W\IIIIttalQOO1UoIs ~rt.1IAI EOrhd. 21st Century r!Chnolagy I Unique, unparaUeled research Dpportunities Purpose: To gain an accurate understanding of the true relationship between benzene exposure and the risk of disease. This study would lead to improved benzene-driven, health-based regulatory standards by providing the regulatory and scientific communities with information for more accurate assessment of the risks from exposure to benzene. Opportunities: A unique set of opponunities exists at this point in time in Shanghai to conduct meaningful bcnzenc research, including high occupationaJ exposures that do not exist anywhere in the West, willing co-investigators influential in local scientific, medical, and regulatory establishments. Therefore, questions that have plagued and confounded benzene health risk assessment for decades appear to be answerable in Shanghai. Challenges: The proposed studies meet several technical, ethical, and culturaVpolitical chaBenges. .! Technical - In order to stand up to scientific scrutiny, studies must be large, well-managed, and incorporate the latest technology. State-of-the-art research is absolutely necessary to make rea) progress in changing the existing benzene risk assessment paradigm. .! Ethical - To address the ethical issues, the study protocols have all undergone a thorough analysis to ensure that the subjects are appropriately compensated for their participation; that both the subjects and communities benefit from having participated in the study; and that worker safety win improve. An Eiliic5 Panel is part of the oversight for the project and includes a Chinese bioethicist. ! CulturalfPolitical - In order to address the realities of doing research in China, collaborators on these studies include researchers from the Medical School at Fudan University. the Shanghai Municipal Centers for Disease Control (responsible for occupational exposure monitoring and enforcement). 2116/2001 MOC00044972 ---------.----~. U MCraig Parker: OncPager.doc Proposed Studies on the Risk of Page 2Benzene-Induced Diseases in China Page 2j Benefits of Extensive Collaboration CHINESE PERSPECTlVg Imp<>",s n-.. _ W<O\SC >- $t<.OdyMcrthad .. e:><pen:lsoo >- I.._dl"" Toc:hno'Dgy .. Know-How _,""",",01'".. e ............... Adv_oc....._ _llo:.U.,n. ......._.ns TraIning OPporturllU .. .-11.,_ c.r....................y In FUfurc: u.s. PERSPECPVE "-!]I........ ReqUIIIU,Q ., 8.OCI_ _1'I1",., I~ ...... "r. ~rs...." Ac,Jeq ... ".nldpaUon ... cnt1 _ _ $Iudy 1R>pQQ" R .. ' ....a.n<:>o> .. Imp.a.. on:: _ I _ _ .g~_ ry _.rr..c .. In Chi" Benefits: Infonnation gained from this project will have a direct, cross-media impact upon regulatory standards designed to protect workers and the general popu1ation from benzene-induced disease. These include air and water quality standards, as wen as hazardous waste and site remediation standards. The infonnation gained from these studies will assist contributing companies in achieving product stewardship goals and will be useful in defending the industry's risk reduction programs. Additional benefits from this collaborative approach are outlined below. 2/1512001 MOC00044973 Proposed Studies on the Risk of P.ge3Benzene-Induced Diseases in China The Studies: TIm::c inter-related studies have been proposed for this project: Page3! Shanghai Benzene Study structure - Cue-Conlto1 51"" \ ...,Disease Progression o <~&! ~. Makal1ar Epllkmlolo!n' ""'Y I;F ~ S/3'e.(lfll:e-AI1 HEMATOLOGY ~SOR,UCRI" ~ ~ I WORKSITES Case-Contl'Ol Study - A hospital-based case control study to investigate the potential relationship between benzene exposure and both Non- Hodgkins Lymphoma (NHL) and Acute Myelogenous Leukemia (AML), including an attempt to quantify the potency of benzene for Ute AML response. Disease Progression Study - A hospitaVclinic-based investigation of the relationship between noncancer diseases of the bone marrow and AMI. (cancer) to detennine if effects on bone marrow progress through non-cancer stages to an ultimate leukemia. This study would also attempt to define the shape of the dose response for these "precursor" diseases and could result in characterization of unique identifiers ofbenzeneinduced AML. Molecular Epidemiology Study - Investigate if there is a quantitative relationship between benzene exposure and potential early indicators of both exposure and effect in a focused population of benzene exposed workers Tolal Cost Estimate (2001 U,S, Dollars) Seed Monies $500,000 Study Costs Case-Control Study Disease Pmgrcssion Study Molecular Epidemiology Study .$1,761,000 53.494,000 $3,275,000 Hematological Laboratory in Shanghai $8,340,000 External Communications 51,000,000 Other Costs (Admi.nisttarive, Travel, Ethics Panel, Scientific Oversight Panel) $1,341,000 GRAND TOTAL 519,713,000 Costs: The estimated costs for the project were derived after careful consideration of aU afthe technical, ethical, and political issues. Therefore, the estimated costs are fairly stable and are not anticipated to 211612001 MOC00044974 [Cralg Mp.arker - Onepager.dac :4 Proposed Studies on the Risk of Page4Benzene-Induced Diseases in China increase by much (inflation has been incorporated into the estimate), Page 41 Funding: Funding for the project wiH be handled by a consortium of interested stakeholders, with shares detennined by size of the contributing organization. The proposed funding fannula was devised based on the assumption that most of the support will come from the petroleum and petrochemical industries. It is anticipated to take five years to complete the project. and that tlte costs will be highest in the first yenTS of the project. Example Funding for One Share By Project Year* Study Year I 2 3 4 5 Pereent of Costs 30 25 15 15 15 Total: Cost Per Share $422,400 S352,OOO S211,200 S211,200 5211,200 51,408,000 *Assumes that there an: a total of 14 shares at approXllllarely 51,408,000 per share. Costs per share may increase or deere (i.e., tota] number of shares). P..posed Funding Formula Share DcterminatioD Sharebolder Category Sbares U.S. Refiner (based on U.S. refinery capacity)- Sm;IIlI (S: 500,000 bbVday), I Medillm (>500.000 ,;omd ~ 1,SOO.OOO bblltby) 2 Urge (> 1..SOO.OOO bbllday) 3 Non-U,S. Refiners (no U.S. rc:fmeries) I FreeStaoding Chemical Co. (No refioeries) 2 Upstream Company (No reHneries) 1 Other (trade association,. gove.mrnent. NGO) Negotiable U.S. refinery capacity WIll be detennmed based upon refmery ownersbip as of October I. 2000. Capacity will be ea Journal's 2000 PennweU Directory. For more informatioD contact: Lorraine Twerdok (API) at (202)6828344 or twerdokl@api.org; or Patrick Beatty (Chevron) at (5\0)242-7037 or pwbe@chevron.com 211612001 MOC00044975