Document Oz1g3an3ajzoX77owXnzweddj

Shanghai Health Study Overview Goal: Conduct benzene health research in China. Purpose: To gain an accurate understanding of the true relationship between benzene exposure and the risk of certain hematopoietic diseases. This study would lead to improved benzene-driven, health-based regulatory (e.g., ambient air, water & occupational) standards worldwide, by providing the regulatory and scientific communities with information for more accurate assessment of the risks from exposure to 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 willing and qualified co-investigators influential in local scientific medical, and regulatory establishments. Therefore, questions that have plagued benzene health risk assessment for decades appear to be answerable in Shanghai. The Studies: Three inter-related studies have been proposed for this project: 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 hospital/clinic-based investigation of the relationship between non-cancer diseases of the bone marrow and AML (cancer) to determine 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 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 a focused population of workers. Benefits: 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 assist contributing companies in achieving the highest product stewardship goals and in oversight of their risk management programs. Challenges: The proposed studies meet several technical, ethical, and cultural/political challenges. Technical - In order to stand up to scientific scrutiny, studies must be large, wellmanaged, and incorporate the latest technology. State-of-the-art research is absolutely necessary to make real progress in developing sound benzene risk assessments. Ethical- To address the ethical issues, the study protocols have all undergone a thorough analysis to ensure that: the subjects and participating communities benefit DRAFT March 22, 2002 - 1- SH ELL-MCCLU RG-055343 Shanghai Health Study Overview from having participated in 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. Cultural/Political - In order to address the realities of doing research in China, collaborators on these studies include researchers from the Medical School at Fudan University, and the Shanghai Municipal Centers for Disease Control and Prevention (responsible for occupational exposure monitoring and enforcement). Costs: The estimated costs for the project were derived after careful consideration of all of the technical, ethical, and political issues. (inflation has been incorporated into the estimate). Item Case-Control Study Disease Progression & Molecular Epid. Studies Total Research Costs Scientific Review Panel Ethics Review Panel External Pathology & Cytogenetics Workgroups Total Panel Costs Outside Counsel Public Affairs QAlQC Activities Miscellaneous Costs Subtotal Administrative Overhead (5%) GRAND TOTAL Cost Estimate $2,283,100 $16,702,000 $18,985,100 $648,000 $216,000 $130,000 $994,000 $125,000 $1,000,000 $225,000 $1,350,000 $21,329,100 $1,066,500 $22,395,600 Funding: Funding for the project will be handled by a consortium of interested stakeholders, with shares determined by size of the benzene related operations of the contributing organization. The proposed funding formula 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. DRAFT March 22, 2002 -2 - SH ELL-MCCLU RG-055344