Document VyZ0D4QxdQJw8jkO74J8Vp98

External Affairs Director for Shell Companies in North East Asia Floor 33, Tower 2, China World Trade Centre, No 1 Jianguomenwai Avenue, Beijing 10004 People's Republic of China Tel: +861065054919 Mob; +86 13901373684 -----Original Message----- From: Clegg, Patsy M SCC-CHSE-PC Sent: Thursday, 29 August, 200223:33 To: Wood, Nick N SCHINA-EA Cc: Sullivan, Nancy E SCC-CBAR; Colletti, Sarah J SCC-CSEA Subject: Shanghai Benzene Health Study Nick, I was given your name by Sara Colletti as the appropriate person to contact to begin discussions on informing the right people involved with the Nanhai project about a large benzene health study being co-sponsored by Shell Chemicals in Shanghai China. Nancy Sullivan, VP of the Aromatics/Phenol PBU, is the business sponsor. I represent Shell on the oversight committee for the consortium sponsoring the study. We also have representatives on the technical, communications and legal committees. As a starting point, I am sending you the pre-reading and slides used at a recent presentation to US oil and chemical high level staff including Fran Keeth, EVP for Customer Fulfillment in Shell Chemicals and CEO of Shell Chemical LP in the US; Nancy Sullivan; AI Schmidt, manager of HSE Product Stewardship for the former Equiva (now Shell Oil Products) representing Judy Moorad, VP HSE; Alistair Fraser, Medical; and US Shell Chemicals Issue Management. I would like the opportunity to discuss this project with you and develop a plan to keeping the Nanhai project people updated. File: Shanghai Benzene Health Study - Summary.doc File: China basic intro talk 7-02.ppt (Compressed) Best regards, Patsy Clegg Product Steward Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713241 2521 Fax: 3325 Email: pmclegg@shellus.com Internet: http://www.shell.com/chemicals -----Original Message----- From: Colletti, Sarah J SCC-CSEA Sent: Thursday, August 29, 2002 10:06 AM To: Clegg, Patsy M SCC-CHSE-PC Subject: PN: benzene study -----Original Message----- From: Wood, Nick N SCHINA-EA Sent: Thursday, May 23, 2002 6:43 PM SH ELL-MCCLU RG-067970 To: Colletti, Sarah SJ SCC Cc: Wang, Yean-Sung YS SC-CXHC; Briggs, Barnaby D SC-CSEA; Freer, Jacky J SC-CSEA; Tan, EkKia EK SCHINA-CH; Vong, Tanny VK SCHINA-EAG; Ng, Nicholas WK SHELHK-CHOS Subject: RE: benzene study Sarah, Indeed we have several major projects with Sinopec involving EP, OP and GP. We supported their IPO in 2000 and have a Strategic Alliance with them that includes a number of projects, the biggest of which is a 500-station retail joint venture in Jiangsu in East China. I copy in Tanny, who can advise you further as our government affairs manager. I am still waiting for a few more details of this multimillion dollar study in China, about which we were not informed. This would be a good starting point. Nick From: Sent: To: Cc: Subject: Colletti, Sarah SJ SCC Thursday, May 23, 2002 11 :09 PM Wood, Nick N SCHINA-EA Wang, Yean-Sung YS SC-CXHC; Briggs, Barnaby D SC-CSEA; Freer, Jacky J SC-CSEA benzene study Hi Nick, Does Shell have any dealings with SINOPEC? If so, do we (the consortium of companies working on the benzene shanghai study)need to approach them about the Shanghai Benzene study that is being planned.? Are there sensitivities we should know about? If we should approach, what would be the best way to do it? This is all for the purpose of planning a communication strategy around the study.... Any advice would be most appreciated .. Thanks, Sarah SHELL-MCCLURG-067971 Shanghai Health Study Sponsored by Benzene Health Research Consortium Shell Update April 2004 SH ELL-MCCLU RG-067972 Shanghai Health Study Program Current status of studies Program management Communication and outreach Shell activities Opportunities SH ELL-MCCLU RG-067973 Health Effect Study of Benzene in Shanghai AML/NHL Case Control Study I AA/MDS/AML/BP Disease Progress Study Molecular Epidemiological Study of Benzene Exposure I Joint Sino-US Clinical and Molecular Laboratory CJCML) SH ELL-MCCLU RG-067974 AML/NHL & DP Exposure Assessment Overview Hospital recruitment, cases of BP1 (10/year) AA 2 (SO/year) MDs3 (60/year) AML4 (120/year), NHL 5 (120/year) L...f> 10aO/year, 5/day ~ ~........ Two matched controls selected per case Initial exposure assessment - work history, -IPHS database - facility records, - Other I Clarify or Verify & Noor? characterize main exposures v I Yes Construct Detailed Exposure Assessment Periodic Review, Job - facility - exposure - time matrix Recycle 6 II Exposure reconstruction - historic measurements, history of changes in methods, facilities, materials, etc. - retrospective estimation - physical recreation Exposure surveys - facility summaries - worker or surrogate exposure monitoring - air samples - biological monitoring SH ELL-MCCLU RG-067975 Shanghai Health Study Current status of studies Study began accruing cases in July 2003 - meeting expected case targets: 26 hospitals participating - Cases versus expectations as of December 2003: BP (0 vs.10/yr), AA (17 vs. 50/yr), MDS (26 vs. 60/yr), AML (42 vs. 1OO/yr), NHL (66 vs. 120/yr). Diagnosis of laboratory versus secondary pathology review high, > 90 %. Investigators considering protocol revisions, with scientific review, both University Institutional and Consortium Science Review Panel (SRP). Exposure assessment a current focus of the SRP. Process underway to replace chair of Ethics Review Panel. Seeking new US member along with current members (China and EU). SH ELL-MCCLU RG-067976 Shanghai Health Study Program Management Budget planning - Budget revised to meet new funding level, $21.08M - Quarterly financial report format expanded to include study milestones (cases accrued). - Investigators working on reporting costs and cost projections based on accrual rates for improving spending rate estimates. - Current budget spending projections suggest additional consortium member payments not required until 2005 or perhaps 2006 (to be clarified by 2Q04). Contract reviews completed API-BHRC contract currently being revised External Stakeholders Engagement - Consortium meeting - April 2004. SH ELL-MCCLU RG-067977 Shanghai Health Study Communication and Outreach First Annual Meeting was a success Launch event celebrating completion and start up of the laboratory - December 2003 Stakeholder Engagement to begin API Engagement - Ed Murphy, Downstream, RES, Subscription Projects Next annual meeting - August 2004 Annual meeting in Shanghai - Nov 2005 SH ELL-MCCLU RG-067978 Shanghai Health Study Communication and outreach Stakeholder Engagement discussions Beginning discussions identified a broader range of intentions of consortium members than anticipated. Next meeting April 21-22 to align intentions and/or reach understanding. SH ELL-MCCLU RG-067979 Shanghai Health Study Communication and outreach Shell intentions to be based on: - Protecting reputation - in China and around the world. - Protect relationships/investments in China. - Meet commitment to transparency and ethics. - Protect credibility of project and participants. - Raise awareness and understanding of the project. - Secure buy-in and constructive feedback into the process. SH ELL-MCCLU RG-067980 Shanghai Health Study Shell Activities Comprehensive Shell internal communication plan has been drafted, includes: - Global Shell engagement on regular basis - Quarterly updates - Issues management process - Ongoing connection to Shell China external affairs team. - E-news (on a quarterly basis). SH ELL-MCCLU RG-067981 Opportunities Opportunities for enhanced outreach and communication: Shell currently holding consortium leadership positions: Patsy Clegg - consortium oversight committee Chair Stuart Cagen - technical committee Vice-Chair and Chair of finance committee Shan Tsai - adjunct professor, Fudan University Shanghai Benzene Study contributes to a larger global benzene industry research effort: - Benzene Symposium - Munich, Germany - October 2004 - CONCAWE benzene epidemiology meta-analysis - ongoing. Shell participation via Health Services SH ELL-MCCLU RG-067982 Nela Briefing Points: Important Study - This study will have implications in the following ways: o Efforts to engage and manage stakeholder concern about Shell's impact on community/fenceline/product health issues o Reputation and position in China o OP has benzene in its feedstocks and gasoline (consumer exposure)? o Identify health impacts and level of exposure at which effects are seen o Provide data to determine whetherprotocols and business practices need to be adjusted o o Protect reputation on Benzene Shell and other Consortium members have some recommendations for improving process: o API management - further document review and control to ensure consistency of message o Project management Cost management/controls Scope creep Stakeholder engagement- proactive strategy Next Steps aimed toward implementing recommendation above (for internal Shell discussion only) o Nancy Sullivan will engage business equivalent consortium members o Participate in consortium!API discussion about closing the financial gap o Sarah and Lauren are taking proactive role in developing stakeholder engagement/public affairs strategy o Chemicals is lending support to help build financial control structures (Tarita' s time) o The Benzene PBU budgeted funds in draft 'tox' budget for next year Nela/OP's role for API Meeting: June 19th o Talking Points: Reiterate the importance and benefits of the study for the industry as a whole API's financial support is important o (footnote: The five participants contributed significantly (16.5MM); those members pay 80% of the API dues) The whole industry will benefit from the study findings Issues: may be raised at meeting Why is Shell Oil not participating? Governance/timing issue - different OUs have different focuses - Shell Chemical is the biggest stakeholder in Royal Dutch; ranking #2 in Benzene market. Why isn't ACC providing support? Ten years ago, ACC and API decided to allocate responsibility for products - API got Benzene and ACC got BD. SH ELL-MCCLU RG-067983 The Shanghai Health Study Sponsored by: Benzene Health Research Consortium 1 SH ELL-MCCLU RG-067984 Presentation Topics ~:::itl:~::t::::~:mm:~:::: Shangha-I Health Study Overv-Iew .':~t~~t~:{::t~~i:~f.' Current Benzene SC-Ience ::~:I:~: Shanghai Health Study Elements ~:~::.:~:~ Shanghai Health Study Sponsors ::;::: Shanghai Health Study Funding Structure .::::::/:5~~:{i:f. SheII Steerl-ng Team Study Challenges&I}\t:'~~::::~:i:~::;;' 2 SH ELL-MCCLU RG-067985 What is the Shanghai Health Study? ::~:I:~: A long-term clinical study to investigate the potential causes and development of Iymphohematopoietic diseases (diseases of the lymphoid organs, blood and bone marrow) as related to benzene ::~:!:~::~ A project of Fudan University Medical Center; University of Colorado Health Sciences Center; Applied Health Sciences - an independent U.S. research firm; Chinese public health agencies; and Shanghai hospitals 3 SH ELL-MCCLU RG-067986 Shanghai Health Study Purpose Ct To gain a quantifiable understanding of the relationship between benzene exposure and potential associated cancer risks ~:~:H:~:~ Researchers will use cutting-edge technologies to advance the understanding of benzene-induced disease 4 SH ELL-MCCLU RG-067987 Why Shanghai? C') Unique Study Environment I:;"I: Databases documenting exposure :Ii'I: Exposure across industries I}I: Range of exposure levels Committed Collaborators =;::1111:1:::111::;; :I;:I: Government :::::!':I: University and hospital based researchers I:;"I: Community hospitals :Ii'I: Shanghai Municipal Center for Disease Control and Prevention iii::;,::::: Institute for Public Health Supervision 5 SH ELL-MCCLU RG-067988 Unparalleled Collaboration "Th-IS study -IS an enormous:t:\:~::::. ..,:::t~~~~;::~: collaborative effort, unlike anything America nand Chinese resea rchers have ever done. II - Dr. Richard Irons, PhD, SHS principal investigator, professor and director of the University of Colorado's Molecular Toxicology and Environmental Health Sciences Program 6 SH ELL-MCCLU RG-067989 Difficulties in Past Benzene Research C~) Animal models do not replicate human benzene-related diseases RetrosQect-lve resea rch~:::itl:~::t':;:::;~~~~~::::~. -----+---::::::=::::::: Review case files of people who have died ~:::~: Rely on inexact diagnoses :::::::t::: Accuracy of reconstructed exposure data :::: Guess at lifestyle and dietary habits 7 SH ELL-MCCLU RG-067990 How is the SHS Distinct? ProsQect-lve resea rch::::~:}:1t~.::::;;~;;;;;::::. -----+---:~:i:~: Patients at participating hospitals suspected of having a lymphoid, blood or bone marrow disease will be referred to the SHS :~:i:~: Patients' diets, environmental exposures and family histories will be recorded :iI:i::::i:i: Patient disease progression followed at supporting hospitals 8 SHELL-MCCLURG-067991 Shanghai Health Study Clinical Laboratory Support Sino-U.S. Joint Clinical & Molecular Lab Referral Hospitals Outside Benzene Cases Consultation SUJCML Laboratory Study Data Ex osure SMCDCP r+-_......iiiiiiiiiiiioiiiiliiio.........iiiioIiooiiiio_....j IPHS Case 1.0. Institute for Public Health Supervision Shanghai Municipal Centers for Disease Control & Prevention Case Disease Molecular Control Progression Epidemiology 9 SH ELL-MCCLU RG-067992 How is the SHS Distinct? C. Study will be able to examine primary diagnostic and medical data in real time C. First-hand exposure reports are more reliable than second-hand or reconstructed information :~:iI:!:I:i; State-owned databases document worker histories 10 SH ELL-MCCLU RG-067993 Shanghai Solutions i:::i::~: Unique Study Environment i:::i::~: Unparalleled Collaboration i:::I::~: Shanghai Health Study Genesis ~::::I:::: Ra re 0 pportu nity i::::::::::::::::: Shanghai Health Study Partners :~::i:::i Shanghai Health Study Hospital Partners :~::i:::i Sino-U.S. Joint Clinical & Molecular Lab 11 SH ELL-MCCLU RG-067994 Unique Study Environment: Shanghai :~::I:~: Robust data set ::;::: State-maintained benzene exposure and health effects databases documented from 1970s i:[::::i:i Benzene related health effects are #2 in reported chronic occupational health hazards in China in 2001 (Source: Ministry ofPublic Health) I}I~ Large range of exposure levels from a variety of occupational sources :::;:: Regulatory authorities interest in improving benzene exposure regulation and enforcement 12 SH ELL-MCCLU RG-067995 Unique Study Environment: Shanghai !:~:I:I:~!: China interested in scientific basis for improved worker-safety regulations !!!::{!!! Chinese occupational standards based on measurable human health effects :~:~:i:~:~ Chinese Occupational Diseases Protection Law (effective May 1/ 2002) ::{: Increases worker protections !:!::{:!: Specifies company role regarding worker health problems resulting from occupational exposures ::{: Benzene receiving additional scrutiny 13 SH ELL-MCCLU RG-067996 Unique Study Environment: Shanghai c" High interest in collaborating on research ~!:.::~~ Technology transfers :~;I:{~:~: International health standards :::::::\::::::I::': State-of-the-art lab/ equlpment ~:;:::~i Sha nghai hematology/pathology communities support and expertise ~!:::~~ Strong research program supports China's regulatory understanding and objectives 14 SH ELL-MCCLU RG-067997 Unique Study Environment: Shanghai f) Fudan University Medical Center iI!::ti:l Research partnership with a leading research university f' Community participation ~::':!~:l 30 hospitals will refer patients to the SHS i:i::::':::i:l Shanghai Municipal Center for Disease Prevention and Control :~:}:;:~:l Shanghai Institute for Public Health and Supervision 15 SH ELL-MCCLU RG-067998 SHS Genesis NCIjCAPM study -In Shangha-I:{!t~~t:'~:::~:i:~:::::;' I}I! Retrospective study published 1997 ::t::::::: Raised new questions on effects of low-level benzene exposure :!~::I:~: Assessed feasibility of building on Shanghai experi-ence !:~:I:i:~:~ Three distinct, highly integrated studies designed 16 SH ELL-MCCLU RG-067999 Rare Opportunity i::~:.::~:i Unique data set i:~:.::~:i Technological advances ::~I:I:~: Early, consistent detection and diagnosis of leukemias and related diseases in Shanghai :~:~:.:~: Identification of more sensitive benzene exposure biological markers :::::::::!::::::: Convergence of company and local Shanghai research interests 17 SH ELL-MCCLU RG-068000 Shanghai Partners Ct Fudan University Medical Center f) Institute for Public Health Supervision Shanghai Public Health Bureau .;:~t~3t::;.;~;~lIn;~l~;;:;: Shangha-I Hematology Soc-Iety Shangha-I Pathology Soc-Iety;:;~:::;tmlf}Mt;:r:~;'. ~) Shanghai Municipal Centers for Disease Control and Prevention 18 SHELL-MCCLURG-068001 Epidemiology Conclusions pre-1997 :::::::::!::::::: Acute Myelogenous Leukemia (AML) associated with benzene ::,:: No risk at exposures < 1ppm I:,:::::: Clear risk at exposures > 20 ppm :!:::{!:! Insufficient data at 1-20 ppm to assess risk :~::I:i~: Some steps are not dose-dependent and are governed by a threshold mechanism :::::::::!::::::: All steps required for induction of cancer have not been determined 19 SH ELL-MCCLU RG-068002 u.s. Regulatory Interpretation co Regulatory decisions based on no- threshold assumption :i:i:!:i:i:i~ More research needed to assess threshold assumption 20 SH ELL-MCCLU RG-068003 Recent Epidemiological Studies Ct National Cancer Institute Shanghai Study (NCI) - case-control study published in 1997 iiii:;:::iiii Benzene associated with AML and Non Hodgkin's Lymphoma (NHL): unusual association with a non-AML cancer II:Il Study design did not add to understanding of threshold (lowest exposure group was 10 ppm or less) 21 SH ELL-MCCLU RG-068004 Recent Epidemiological Studies C. Australian Institute of Petroleum's (AlP) Health Watch Study - case-control study released in 2001 :~:::~: Association with all leukemias, including chronic lymphocytic leukemia ::::::H::::; No association with NHL or multiple myeloma 22 SH ELL-MCCLU RG-068005 SHS Elements Ct Case Control Study :ir~}t~:~~tt~i1/?' D-Isease Progress-Ion Study Molecular Ep-Idem-Iology.,::mt:t~:~.'~:;~mil;m;::~; Qua I-Ity Sc -I ence,:;~:::f;:m1fJMt~:r:~:'. :~:iI:!:I:i; Scientific Review Panels Cu rrent Status.:;::;~~ltI~r3~t;:~l:~r.' 23 SH ELL-MCCLU RG-068006 Specific Study Goals :~i:~:I:~:i:~ Understand relationship, if any, between benzene exposure and development of specific hematopoietic diseases: AA, MDS, AML and NHL :::::i::::: Causation of specific diseases/subtypes i:nIi Mechanism of disease progression iIiIi Dose-response relationships iIl':Ii Identification of cofactors and confounders iI!':Ii Identification of biomarkers of exposure and disease progression 24 SH ELL-MCCLU RG-068007 Study #1 - Case Control Study ::~:I:~::i Traditional epidemiology study to determine risk of AML, and potentially NHL, among benzene exposed workers :i:~:I:~::~ Data collected will allow analysis of other causal factors for NHL ~:~::I:~:i: Estimate 4 to 5 years to obtain 450 AML and 450 NHL patients into study :i:~:I:~::~ Improved exposure assessment based on historical and concurrent workplace monitoring and questionnaire 25 SH ELL-MCCLU RG-068008 Study #2 - Disease Progression !:~:~:I:~:~ Prospective study on relationship of non-cancer bone marrow disease and benzene-induced AML :lE:::: Is benzene-induced AML different from spontaneous AML by unique cellular markers? i1E::i: Does AML involve a progression through one or more non-cancer states? !:~:~:i:~:~: Research methods: questionnaires, interviews, review work histories; examine blood, breath, urine; study/evaluate potential biomarkers 26 SH ELL-MCCLU RG-068009 Study #3 - Molecular Epidemiology !:~:~:I:~:~ Prospective study to establish quantitative relationship between exposure and effect :;g:~: Do low benzene exposures cause blood effects? :;:{:: Is there an association of blood effects and genetic susceptibility? :(I:;::::: Do biomarkers of exposure accurately reflect workplace exposures? :~:~:I:~::~ Healthy workers at sites with varying levels of benzene exposure will participate; extensive lab work, including genetic tests, will be conducted 27 SHELL-MCCLURG-068010 Qualify Science :~:!.:~::~ All protocols reviewed and approved by external Institutional Review Boards (IRB's) :!:::=:I: Govern use of human subjects :;:: u.s. and China independently ::~t:t~::'~t~~~:1:i~~::::' Shangha-I Health Study panels t:::I: International Ethics Expert Panel ::::i{::: International Scientific Expert Panel 12 members 6 scientific disciplines :!:::=:I: Involved during entire project 28 SHELL-MCCLURG-068011 Current SHS Status i:~:!.:!:~:i State-of-the-art laboratory constructed on Fudan University campus I::::I Sustainable technology transfer an important project design component I:'i::~: Built according to international standards I:':::::: Lab will support the project, Shanghai medical community and remain at Fudan Technology transfers::::::i::!i:::::: :~:g:~:~ Chinese staff receiving training at University of Colorado :::::=t::: U.S. researchers worked with Chinese colleagues and government officials to finalize methodologies, questionnaires, etc. 29 SHELL-MCCLURG-068012 SHS Projected Timeline :::;:: Questionnaire development, pilot testing, 2002 ::~:I:~: Key laboratory personnel trained, 2002 ~::::fl?t: Laboratory completed, early 2003 ::;::: Case recruitment began - 3rd quarter, 2003 :;EI:: 1600 benzene exposed workers, 400 controls :iH:::: Time necessary to identify qualified patients :iH:::: Length of study may be extended if required :::;:tf{J~ftf: Open-Ing Ceremony - Dec, 2003 ~:~::.:~: Research, analysis expected 2003-2007 ::;::: Results published upon project completion 30 SHELL-MCCLURG-068013 Who is Sponsoring the SHS? :~:~:!.:~::~ A consortium of petroleum and chemical companies concerned about understanding the human health effects of benzene ~;:::~: British Petroleum, ChevronTexaco, ConocoPhillips, ExxonMobil, Shell Marathon/Ashland providing additional support :iH:::: American Petroleum Institute, project administrator 31 SHELL-MCCLURG-068014 Why Industry Sponsors? SHS goal to provlde an accurate''~:::~i~~i~(~:j1}:i:~:~::,;:.' understanding of how benzene works on a molecular level in humans :Ii'I: Product stewardship and corporate responsibility programs iIl"Ii Advanced understanding of benzene-induced disease could lead to development of effective disease prevention strategies :::::!"::::: Would allow a more finely calibrated assessment of potential health effects III: Provide best protection for workers and public 32 SHELL-MCCLURG-068015 Why Industry Sponsors? C~) Worldwide, benzene occupational exposure regulatory standards vary widely I:::I~ O.5ppm in Malaysia; 1.Oppm in U.S.; lOppm in Japan :~;:::~: American Conference of Governmental Industrial Hygienists recommends O.5ppm c") Industry has long sponsored benzene research 33 SHELL-MCCLURG-068016 SHS Funding Structure :i~::I:~i:: $20.8 million program total for all costs over 5 years iIi:Ii Sponsor allocation originally based on refinery production capacity in Oct 2000. iIl':::::i Additional funding committed in 2003 based on 0/0 of original commitment :IiI: $16.5 paid by sponsors thus far 34 SHELL-MCCLURG-068017 Conclusions (") Study will advance benzene science Sponsors fund-Ing study.:tl}tt'::;;~t[}l~~::;: Product stewardship:iii:=:!::i:ii :ii;:=ti:i: Corporate social responsibility goals (.) Anticipate results published 2007/8 .) Results will add to accepted body of scientific resea rch on benzene i:I::"::::i:! Referenced by government, industry decision-makers 35 SHELL-MCCLURG-068018 Shell Team :~::.:~: Steering Team: Business sponsor, HSE, EA, legal, finance, OP ::;:;:: Shell Reps to consortium i:(:::::iIi Patsy Clegg, Oversight Committee :i:::::!::i:i: Stuart Cagen, Technical & Budget Committees :~:::~: Shan Tsai, Technical :;1,:::::::::;: Sarah Colletti, Communications (.) Shell Financial Commitment: $4.1MM 36 SHELL-MCCLURG-068019 Shell Strategy :~::.:~: Issue Management: On CEC, CMD Issue list C~, Quarterly communication to a broad distribution C"' Active participation in consortium 37 SH ELL-MCCLU RG-068020 Stduy Challenges ::~:~:.:~:~:: Exposure Assessment :~::.:~: Sustainability of lab when study is concluded ::~:~:.:~:~:: Bud9et 38 SHELL-MCCLURG-068021