Document BRjEyMvBGVONnDzEq5KMD3k9o

From: Sent: To: Subject: lannarone, Lauren B SCC-CSEA Monday, September 27, 2004 2:34 PM Clegg, Patsy M SCC-CHSE-PC RE: Issues Documents for Shanghai Benzene Study Importance: High Patsy - sorry for the delay on getting this out - the attached is the final version with your comments embedded - to confirm recipients, see below for a list and please advise who I am missing! Also - as the focal pOint, would it be most appropriate for you to send the communication? Please advise, thanks! Regards, Lauren Sam Smolik Susan Tholstrup Stacy Methvin Nancy Sullivan EkKia Fran Henry Wang Nick Wood Mike McGarry Jeremy Freerson ID for China - will have to confirm who that is Tim English Shan Tsai Stu Cagen Robin Aram Johan Breuklaar Barnaby Briggs Dave Harrington (OP/EA - US) David Sexton (OP and will pass on to advise Lynn E.) Sally Hopkins Dave Waskowiak Tarita Sam uel Sarah Colletti Yean -Sung Wang q4summary-final.d oc (Compresse... Lauren lannarone Issues Manager Shell Chem ical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 SH ELL-MCCLU RG-059995 Tel: +1- 713-241-7283 7283 Other Tel: 917-362-5456 Email: Lauren.lannarone@shell.com Internet: http://www.shell.com/chemicals -----Original Message----- From: Clegg, Patsy M SCC-CHSE-PC Sent: Wednesday, September 15, 2004 11:59 AM To: Iannarone, Lauren B SCC-CSEA Subject: PN: Issues Documents for Shanghai Benzene Study Importance: High Lauren, Apologies for not following up sooner. I am okay with the issues list and matrix. Made a few suggested changes in the 3Q04 update. Had a call this morning with Nancy, Susan, Sam Smolik, and the 3 regional VPs for Base Chemicals to talk about transition to the base chemicals as sponsors. Have a lot of action items and need to discuss with you. Will call you later. Haven't forgotten the CAA residual risk - will follow up shortly. 2(fgar'i; Patsy Patsy Clegg Product Steward Shell Chem ical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals -----Original Message----- From: Iannarone, Lauren B SCC-CSEA Sent: Tuesday, September 14, 20045:54 PM To: Clegg, Patsy M SCC-CHSE-PC Subject: PN: Issues Documents for Shanghai Benzene Study Importance: High Patsy - any thoughts on the info below? If we are going to send Ek Kia a note, perhaps we could send him something to the q3 update below - let me know if you want Mike McGarry to send to him? He is in Beijing starting tonight our time - Let me know your thoughts - thanks! Lauren lannarone Issues Manager Shell Chem ical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1- 713-241-7283 7283 Other Tel: 917-362-5456 SH ELL-MCCLU RG-059996 Email: Lauren.lannarone@shell.com Internet: http://www.shell.com/chemicals -----Original Message----- From: Iannarone, Lauren B SCC-EXT AFF Sent: Thursday, September 09, 20049:04 PM To: Clegg, Patsy M SCC-CHSE-PC; Tsai, Shan P SHLOIL-SHS; Cagen, Stuart Z SCC-HSE; Sarah J SCC-CSEA Colletti (E-mail) Subject: Issues Documents for Shanghai Benzene Study Dear all: As discussed, please find a revised issues matrix and issue plan. I have developed a template that can be used - I need your help in filling this out if you think it would be helpful. I am also attaching a draft 03 update on the study for dissemination to our internal Shell stakeholders - please review, edit and/or add anythign that I missed. I have to confess that I borrowed language from the API summary note. Hope this is ok - we can try and get the internal summary out in the next week or so, if you would like - Best Regards, Lauren File: issueplan_sept04v1.doc (Compressed)>> File: ShanghaUssuessept2004.ppt (Compressed)>> File: q4summary_v1.doc (Compressed) Lauren lannarone Issues Manager Shell Chem ical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1- 713-241-7283 7283 Other Tel: 917-362-5456 Email: Lauren.lannarone@shell.com Internet: http://www.shell.com/chemicals SH ELL-MCCLU RG-059997 Shanghai Health Study - Project Update - Q3 2004 September 27, 2004 DRAFT The objective of this memo is to provide an update on the Shanghai Health Study (SHS). This study, sponsored by the Benzene Health Research Consortium of which Shell Chemicals is a member, is a multi-stakeholder health study in Shanghai, China, which aims to better define the hazards and health risks from exposure to benzene. The SHS held its second annual meeting in August 2004 in Monterrey, California. The meeting brought together the Principal Investigators (both Chinese and American research team members), the Scientific and Ethics Review Panel members and the industry sponsors. The objective of the meeting was to provide a forum for reviewing the study's progress to date and expectations going forward. The two-day meeting included an open plenary session intended to discuss the progress of the study to date as well as closed meetings of the Scientific and Ethics Review Panel members and the Principal Investigators. Patsy Clegg, Shell Chemical's Benzene Product Steward and Chair of the Benzene Health Research Consortium Oversight Committee, opened the session emphasizing the participating companies' ongoing commitment to product stewardship; the importance of the industry's commitment to better understanding the potential effects of benzene exposure and the study's role in helping industry effectively manage and minimize risk. Patsy also emphasized the importance of the cooperative and collaborative relationships that have been established among the researchers, the Scientific Review Panel and the Ethics Review Panel. Participants offered their views on some key accomplishments and milestones including: The launch of the start-of-the-art lab Joint Sino-U.S. Clinical and Molecular Laboratory (JCML) at Fudan University in December 2003 Partnership with 30 Shanghai hospitals that have allied themselves with the JCML Since January 2004, the inflow of cases into the JCML has exceeded expectations by two times the original estimate. No cases or controls have refused to participate in the study Several factories have agreed to participate and formal data collection is underway for 34 factories; the PI's conducted preliminary analyses on one factory, a Shanghai rubber factory. Preliminary results indicate that the study will indeed make a difference and help bring new clarity to the field. Some of the key challenges noted at the conference include: Efforts to recruit factories and current workers to participate Data gathering and measurement of the workplace environments Quality control associated with recruiting of participants In closing, the participants emphasized the importance of accurate exposure assessments to achieving the goals of all three studies, seeking to establish dose-effect relationships between benzene exposure and adverse health consequences. The participants also highlighted the importance of ensuring that the JCML continue to operate, providing diagnostic services and support for research long after the SHS concludes in 2006. The 2005 meeting would be held in Shanghai the first week of November. SH ELL-MCCLU RG-059998 Background on the SHS: Shell Chemical is participating in a multi-stakeholder health study in Shanghai, China, which aims to better define the hazards and health risks from exposure to benzene. The project participants include a wide range of stakeholders including the Fudan University Medical Center, University of Colorado Health Sciences Center; Applied Health Sciences, Chinese public health agencies, Shanghai hospitals as well as several peer energy and chemical companies. This study, which is part of our commitment to product stewardship, will help clarify previous assumptions regarding benzene health risks and will also help address some recent questions about benzene hazards and exposure. Further, this information will provide the industry with information, which we can use to determine what, if any, improvements are needed in existing protocols. The study will examine past and current exposures in Shanghai-area manufacturing facilities (none are Shell facilities and the benzene not a Shell product). A state-of-the-art clinical and molecular laboratory was built on the Fudan Medical University campus to support the research project and the Shanghai medical community. Chinese technicians have been trained to operate the lab. This facility will remain at Fudan once the project is completed. For additional information or inquiries, please contact Patsy Clegg at 713-241-2521 or patsy.clegg@shell.com. SH ELL-MCCLU RG-059999 Shanghai Health Study Update to Shell Sponsors and Stakeholders February 27, 2006 Background The Shanghai Health Study (SHS), sponsored by the Benzene Health Research Consortium (BHRC) of which Shell Chemicals is a member, is a multi-stakeholder health study in Shanghai, China, which aims to better define potential human health risks associated with exposure to benzene. Current Status 2005 Annual Meeting: The 3rd annual meeting was help in Nov 2005. Attendees included sponsors (BP, Chevron, ConocoPhillips, ExxonMobil, Shell Chemicals), principal investigators, Scientific Review Panel, and Ethics Review Panel. The investigators presented an update on the 3 studies: 1. Case Control studies of acute myeloid leukemia (AMI,) and NonHodgkin's lymphoma (NHL) 2. Disease Progression of haematopoietic diseases 3. Molecular Epidemiology of cytogenetic abnormalities Case accrual is ahead of schedule tl.1f the case control and disease progression studies with indications that protocol numbers will be achieved by YE06. The diagnostic laboratory supporting the study has been moved, administratively, to a different department (Institute of Biomedical Sciences) within Fudan University. This should facilitate the on-going operation of the lab post Shanghai Health Study in its role to provide diagnostic support to Shanghai-area hospitals. 3 papers resulting from study methodologies and results have been accepted for publication. HIGHLIGHT: Benzene Symposium sponsored by Dr. Jerry Rice, Scientific Review Panel chair, was held at Georgetown University. Purpose of the symposium was to update government regulatory agencies and academia. A new health effect, benzene-induced myelodysplastic syndrome, has been linked to long-term, high level exposure to benzene. Shell in the US filed a TSCA 8(e) on this finding and also revised the Benzene MSDS to include the effect. Exposure Assessment: Continue to have challenges in getting level of exposure data that was originally proposed in the study protocols. Focus is on extra effort and methodology development to do sector analysis. Path Forward 2006: Case accrual complete 2006 Annual Meeting Planning for successful closure of study SH ELL-MCCLU RG-060000 2007: Data analysis Publications Laboratory, tissue bank, and database transitioned to Fudan University 2007 Annual Meeting 2008: Publications continue Study closing event International Benzene Symposium (not a SHS project, but study will be presented) Shell Representatives to BHRC Oversight Committee: Patsy Clegg, Chair Technical Committee: Stuart Cagen, Co-Chair Shan Tsai Budget Committee: Stuart Cagen, Chair Communications: Sarah Colletti SHELL-MCCLURG-060001 Shanghai Health Study Update to Shell Sponsors and Stakeholders February 27, 2006 Background The Shanghai Health Study (SHS), sponsored by the Benzene Health Research Consortium (BHRC) of which Shell Chemicals is a member, is a multi-stakeholder health study in Shanghai, China, which aims to better define potential human health hazards and risks associated with exposure to benzene. This study is unprecedented as an industry initiated program in its aspiration to fully characterize population based haematopoietic diseases using state of the art pathology diagnostic techniques and the WorId Health Organization classification criteria for these diseases. Beyond individual study objectives, the SHS program funded the establishment of a successful and significant diagonistic facility on behalf of the greater Shanghai community. Current Status 2005 Annual Meeting: The 3rd annual meeting was help in Nov 2005. Attendees included sponsors (BP, Chevron, ConocoPhillips, ExxonMobil, Shell Chemicals), principal investigators, Scientific Review Panel, and Ethics Review Panel. The investigators presented an update on the 3 studies: 1. Case Control studies of acute myeloid leukemia (AML) and NonHodgkin's lymphoma (NHL) 2. Disease Progression of haematopoietic diseases 3. Molecular Epidemiology of cytogenetic abnormaljties Case accrual is ahead of schedule for the case control and disease progression studies with indications that protocol numbers will be achieved by YE06. The diagnostic laboratory supporting the study has been moved, administratively, to a different department (Institute of Biomedical Sciences) within Fudan University. This should facilitate the on-going operation of the lab post Shanghai Health Study in its role to provide diagnostic support to Shanghai-area hospitals. 3 papers resulting from study methodologies and results have been accepted for publication. HIGHLIGHT: Benzene Symposium sponsored by Dr. Jerry Rice, Scientific Review Panel chair, was held at Georgetown University. Purpose of the symposium was to update government regulatory agencies and academia. A new health effect, benzene-induced myelodysplastic syndrome, has been linked to long-term, high level exposure to benzene. Shell in the US filed a TSCA 8(e) on this finding and also revised the Benzene MSDS to include the effect. Exposure Assessment: Continue to have challenges in getting level of exposure data that was originally proposed in the study protocols. Focus is on extra effort and methodology development to do sector analysis. SH ELL-MCCLU RG-060002 Path Forward 2006: Case accrual complete 2006 Annual Meeting Planning for successful closure of study 2007: Data analysis Publications Laboratory, tissue bank, and database transitioned to Fudan University 2007 Annual Meeting 2008: Publications continue Study closing event International Benzene Symposium (not a SHS project, but study will be presented) Shell Representatives to BHRC Oversight Committee: Patsy Clegg, Chair Technical Committee: Stuart Cagen, Co-Chair Shan Tsai Budget Committee: Stuart Cagen, Chair Communications: Sarah Colletti SH ELL-MCCLU RG-060003 Shanghai Health Study Update to Shell Sponsors and Stakeholders February 27, 2006 Background The Shanghai Health Study (SHS), sponsored by the Benzene Health Research Consortium (BHRC) of which Shell Chemicals is a member, is a multi-stakeholder health study in Shanghai, China, which aims to better define potential health risks associated with exposure to benzene. Current Status 2005 Annual Meeting: The 3rd annual meeting was help in Nov 2005. Attendees included sponsors (BP, Chevron, ConocoPhillips, ExxonMobil, Shell Chemicals), principal investigators, Scientific Review Panel, and Ethics Review Panel. The investigators presented an update on the 3 studies: l. Case Control 2. Disease Progression 3. Molecular Epidemiology Case accrual is ahead of schedule with indications that protocol numbers will be achieved by YE06. The diagnostic laboratory supporting the study has been moved to a different department within Fudan University. This should facilitate the on-going operation of the lab post Shanghai Health Study in its role to provide diagnostic support to Shanghai-area hospitals. 3 papers resulting from study methodologies and results have been accepted for publication. HIGHLIGHT: Benzene Symposium sponsored by Dr. Jerry Rice, Scientific Review Panel chair, was held at Georgetown University. Purpose of the symposium was to update government regulatory agencies and academia. A new health effect, benzene-induced myelodysplastic syndrome, has been linked to long-term, high level exposure to benzene. Shell in the US filed a TSCA 8(e) on this finding and also revised the Benzene MSDS to include the effect. Exposure Assessment: Continue to have challenges in getting level of exposure data that was originally proposed in the study protocols. Focus is on extra effort and methodology development to do sector analysis. Path Forward 2006: 2007: Case accrual complete 2006 Annual Meeting Planning for successful closure of study Data analysis Publications Laboratory, tissue bank, and database transitioned to Fudan University SH ELL-MCCLU RG-060004 2007 Annual Meeting 2008: Publications continue Study closing event International Benzene Symposium (not a SHS project, but study will be presented) Shell Representatives to BHRC Oversight Committee: Patsy Clegg, Chair Technical Committee: Stuart Cagen, Co-Chair Shan Tsai Budget Committee: Stuart Cagen, Chair Communications: Sarah Colletti SH ELL-MCCLU RG-060005 Shanghai Health Study Update to Shell Sponsors and Stakeholders March 13, 2006 Background The Shanghai Health Study (SHS), sponsored by the Benzene Health Research Consortium (BHRC) of which Shell Chemical is a member, is a multi-stakeholder health study in Shanghai, China, which aims to better define potential human health hazards and risks associated with exposure to benzene. This study is unprecedented as an industry-initiated program in its aspiration to fully characterize population based hematopoietic diseases using state of the art pathology diagnostic techniques and the WorId Health Organization classification criteria for these diseases. Beyond individual study objectives, the SHS program funded the establishment of a successful and significant diagnostic facility on behalf of the greater Shanghai community. Current Status 2005 Annual Meeting: The 3rd annual meeting was help in Nov 2005. Attendees included sponsors (BP, Chevron, ConocoPhillips, ExxonMobil, Shell Chemical), principal investigators, Scientific Review Panel, and Ethics Review Panel. The investigators presented an update on the 3 studies: 1. Case Control studies of acute myeloid leukemia (AML) and NonHodgkin's lymphoma (NHL) 2. Disease Progression of hematopoietic diseases 3. Molecular Epidemiology of cytogenetic abnormalities Case accrual is ahead of schedule for the case control and disease progression studies with indications that protocol numbers will be achieved by YE06. The diagnostic laboratory supporting the study has been moved, administratively, to a different department (Institute of Biomedical Sciences) within Fudan University. This should facilitate the on-going operation of the lab post Shanghai Health Study in its role to provide diagnostic support to Shanghai-area hospitals. 3 papers resulting from study methodologies and results have been accepted for publication. HIGHLIGHT: Benzene Symposium sponsored by Dr. Jerry Rice, Scientific Review Panel chair, was held at Georgetown University. Purpose of the symposium was to update government regulatory agencies and academia. A newly identified health effect, benzene-induced myelodysplastic syndrome, has been linked to long-term, high level exposure to benzene. Shell in the US filed a TSCA 8(e) on this finding and also revised the Benzene MSDS to include the effect. Exposure Assessment: Continue to have challenges in getting level of exposure data that was originally proposed in the study protocols. Focus is on extra effort and methodology development to do sector analysis. Shanghai Health Study - Update to Shell Stakeholders March 13, 2006 Owner: Patsy Clegg 1 SH ELL-MCCLU RG-060006 Path Forward 2006: Case accrual complete 2006 Annual Meeting Planning for successful closure of study 2007: Data analysis Publications Laboratory, tissue bank, and database transitioned to Fudan University 2007 Annual Meeting 2008: Publications continue Study closing event International Benzene Symposium (not a SHS project, but study will be presented) Shell Representatives to BHRC Oversight Committee: Patsy Clegg, Chair Technical Committee: Stuart Cagen, Co-Chair Shan Tsai Budget Committee: Stuart Cagen, Chair Communications: Sarah Colletti Shanghai Health Study - Update to Shell Stakeholders March 13, 2006 Owner: Patsy Clegg 2 SH ELL-MCCLU RG-060007 Shanghai Health Study Proposal for Bringing Study to Successful Closure Draft: August 16,2006 Background: July 31-Aug 2 2006, the investigators, Scientific Review Panel, and Ethics Review Panel met to evaluate progress towards meeting the study aims of the Shanghai Health Study. Members of the sponsoring companies attended as observers. Sponsors did not participate in the technical session. At about the same time, the sponsors received Dr. Irons and Dr. Wong's mid-year reports. Dr. Irons submitted a technical study update to the SRP and ERP. The sponsors received a financial report from Dr. Irons. While good progress is being made, there have been some challenges, which could cause the study to run longer than previously predicted. Loss of lab and exposure personnel is the most significant issue. Options: Irons Budget Additional $ Shell Share Impact on Time Line Impact on Case Accrual Achievements 18.3MM 0 0 Stop case accrual YE06 NHL= 336 18.8MM +0.5MM o(take from contingency $) Stop case accrual YE06; exposure assessment not as robust NHL=433 19.3MM + ~ 1.0MM + ~ lOOK 0 Stop case accrual May 07 0 exposure assessment completed NHL= 500 22.3MM + ~4.0MM + ~ 600-700K 0 Stop case accrual May 07 0 exposure assessment completed 0 full data analysis NHL= 500 0 Built and gifted to Fudan University state of art diagnostic lab 0 Provided free diagnostics to 1000s of Shanghai residents 0 First study to use WHO tumor classifications SH ELL-MCCLU RG-060008 Shanghai Health Study - Oversight Committee Call - June 26, 2003 Shell Notes SUBJECT: FUNDING Study Business Sponsors Call Dave O'Reilly, CEO ChevronTexaco and Chair API Executive Committee, will convene a call of the business sponsors from the 5 Benzene Health Research Consortium companies. The purpose of the call will be decide whether companies are willing to continue support of the study. Marty Bitter, ChevronTexaco Public Affairs Manager, will be making the call arrangements. Nancy Sullivan is the nominated person for Shell. Status of Project Budget on track for activities done - reported by Pat Beatty, chair Technical Committee. There is enough money in the committed dollars to fund the study through 2Q04. Marathon-Ashland has indicated willingness to contribute, but not at a fu1l2-share amount. API and Don Burnett, chair Oversight Committee, to follow up. SARS has impacted the schedule for accepting cases. GolNo Go Decision August 1 set as target date for making a go/no go decision on completing the study. Decision should be an outcome of the business sponsors calls. Potential impacts of No Go: o Focus of Annual Meeting in August o Accepting cases if there is a possibility of not completing the study. API and Pat Beatty will contact Dr. Brody, Ethics Committee. Financial Review by Shell Accountant Tarita Samuel, Shell accountant, will be at API on Wednesday, July 2, to review project accounting. This is being done at the request of the Budget Committee. SH ELL-MCCLU RG-060009