Document jyXv1znyG9RERgpVEqkgyKOop

Shanghai Health Study Overview Purpose: To gain an accurate understanding ofthe true relationship between benzene exposure and the risk of cenain hematopoietic diseases. This study is an important element in the product stewardship programs of participating companies. It can also lead to improved benzene-driven. health-based regulatory (e.g. ambient air, water &. occupational) standards worldwide, by providing the regulatory and scientiJic communities with information for more accurnte assessment of the risks from exposure 10 benzene. A unique set of circumstances exists at this point in time in Shanghai to conduct meaningful benzene research. These include a database of occupational exposures in a different regulatory environment, and wiJling and qualified c()ooinvestigators influential in local scientific medica!. and regulato!), eSUlblishments. Therefore, questions that have plagued benzene heahh risk assessment for decades appear to be answerable in Shanghai, The Studies: The program involves three inler-related studies: Case-Control 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 the AML response. Disease Progression Study - A hospitBllclinic-based investigation of the relationship between non-c&ncer diseases aClhe bone marrow and AML (cancer) (0 determine if effects 00 bone marrow progress through non<ancer stages to an ultimale leukemia. This study would also attempt to define the shape of the dose response for possible "precursor'" diseases and could result in characterization of unique identifiers of benzene-induced AML_ Molecular Epidemiology Study -Investigate if there is a quantitative relationship between benzene exposure and potential early indicators of both exposure and effect in 3 focused population of workers. The investigators are leading experts in their fields., coming from such wetl~known institutions as the University ofCoJorado Health Sciences Center and Furlan University Medical Center. The combined studies apply cutting-edge. 21" century technologies in ways that will not only advance our understanding of benzene-induced disease. but may also identify potential prevention strategies benzene-induced disease in individuals. BeDefils: Information gained from this project will have a direct relevance for worldwide regulatory standards designed to protect workers and the general population from benzene induced disease. These include air and water quality standards. as well as hazArdous waste and site remediation standards_ These studies will wist contributing companies in achieving the highest product stewardship goals and in oversight of their risk management programs. Challenges: The proposed studies mee,t severallechnical, ethical. and cultural/political challenges_ Technical ~ In order to stand up to scientific scrutiny. studies must be large, \Vell~managed. and incorporate the latest technology. State-oftheart research is absolutely necessary to make real progress in developing sound benzene risk assessments. To that end. a Scientific Review Panel make up ofleading experts from a number of fields relevant 10 these studies has reviewed and endorsed the research protocols. Additionally. the protocols have been reviewed by Use of Human Subjects Comminees (IRB) both in the US and China. Ethical- To address the ethical issues, the study protocols have all undergone a 1horough analysis to ensure that they meet international standards for research involving h~ans. including that the subjects and participating communities benefit from having participated in .April 3. 2002 MOC00045073 I. .- Shanghai Health Study Overview the study; that confidentiality is preserved, and that researchers are working with local regulatory authorities to improve worker safety_ An Ethics Panel is part of the oversight for the project and includes a Chinese bioethicist. CullurallPolitical- A key to this program's success is local partnerships. Collaborators on these studies include researchers from the Medical School at Fudan University, the Institute for Public Health Supervision, and the Shanghai Municipal Centers for Disease Control and Prevention (the laner two are responsible for occupational exposure monitoring and enforcement in Shanghai). Funding: Funding for the project will be handled by a consortium of interested stakeholders, with shares determined by size afthe benzene related operations of the contributing organization. The proposed funding fonnula 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 the costs will be highest in the first years of the project. For More Infonnation: Please contact anyone of the following individuals. Patrick Beatty Bill Frick Myron Harrison Chris Roythorne Lorraine Twerdok Chevron Texaco API ExxonMobil BP API Dwbe(Q)chevronle:;;aco.com frickl1llaoLon! mvron.c.Harrisonl'iVexxonmobil.com rovthorcftilbo.com twerdokl(fflaoi.ortt + I 510-242-7037 + I 202-682-8240 + I 972-444-1673 + 44 (0)20 7496 4126 +1 202-682-8344 April 3,2002 - 2 MOC00045074