Document MMzpY8yZK2G9kgoZpaX5x0n99

BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 Tabulate & circulate results from budget plan action items and distribute to OC Mond 12/13/04 Budget action plan items due to API cob, Friday Dec. 10, 2004 (11/3/04) Discuss with Pis NCI offer to assist in exposure assessment All members with action items Tech. Cmtte L. Twerdok OC Members OC Members M. Johnston L. Russo Technical Committee API L. Twerdok OC discussion at 12116/04 m { FILENAME \p } Page 1 of 12 SH ELL-MCCLU RG-OS2S62 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 B.Doll TBC B.Doll OC Members M. Todd OC members P. Clegg & L. Russo Agenda item will be 8 - 10 AM on Thursday, Nov. 4. Information to join by phone will be on the { FILENAME \p } Page 2 of 12 SH ELL-MCCLU RG-OS2S63 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 Financial management: 1. Establish an estimate for additional resources required. (9/13/04) 2. Conduct an analysis of available resources in the BHRC administrative funds (QAlQC) (9/13/04) 3. Provide recommendation for timing of 2005 sponsor invoici at November OC meeti Seek opportunity to provide SHS update to API General Committee on S rams Further investigate cost recovery potentials for the JCML; this activity could be a good way to initiate transition of laboratory to Fudan Unive . Budget - Pursue possibility of SHS clinical laboratory income being used to defray study costs (4/21/04) Technical Budget Committee L. Twerdok M. Johnston & J. Wagner J. Wagner & M. Johnston meeting pending Request to Brenda Hargett 8/30/04 Remind John - need advice & guidance for Nov. OC mtg.; Mike Johnston to work with John on issue { FILENAME \p } Page 3 of 12 SH ELL-MCCLU RG-OS2S64 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 OC lead on lab transition/turnover plan development; work with S. Tsai and J. on issue R. Irons to keep OC informed of progress/decisions by Fudan University on disposition of laboratory; item should be on at least next few Investigator monthly call agendas (8/19/04) B Jarnot Funding sponsor privileges for new sponsors should be used in any updates presented at API, and other presentations as . attached OC members B. Jarnot pending On-going Next update 4Q04 On agenda for next PI call: discussion item in recent meeting between P. Beatty & R. Irons Total number of referrals no available 3Q04 (biannual B. Jarnot OC members complete { FILENAME \p } Page 4 of 12 SH ELL-MCCLU RG-052565 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 Investigators will keep SRP, ERP, Technical Committee and OC updated on upcoming scientific meeting presentations and papers, and circulate draft manuscripts to SRP/ERP and Technical Committee prior to submission to journals (may want to make a standing agenda item for monthly investigator calls) Work with R. Irons to explore use to Shell's access to Shanghai Mayor's Office to request that IPHS devote more experienced IH resources to the stu Evaluate existing QA/QC resources to see if they can be to address IH and QA/QC issues. Work with the investigators in development of proposals on exposure & IH issues; coordinate appropriate review by OC and SRP/ERP coordinate P. Clegg Technical Committee Technical Committee Shell has a visit to mayor's office scheduled for 10104 Target to have initial proposals w/in one month { FILENAME \p } Page 5 of 12 SH ELL-MCCLU RG-OS2S66 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 Update OC on investigators' proposals at the November OC meetin in Houston. Explore funding opportunities with American Leukemia Society, Health Effects Institute (HEI), and International Life Sciences Institute/Health Effects Sciences Institute (lLSI/HESI), and report back on progress at the November OC meeting. (8/19/04) Technical Committee M. Bird Check if BP & XOM have corporate discounts with any of the potential hotels for the 2005 Annual Meeting in Shanghai L. Russo & C. Roythorne Research hotel options for 2005 Annual Meeting in Shanghai and re rt to OC at November OC meeti Outreach - find out relevant professional meeting dates locations and presentation/abstract deadlines via internet (4/21/04 & 6/21 Review organizations & contacts with Matt (6/21/04); Outreach - outreach coordination, make sure circulate summaries as contacts are made Outreach - 2004 Benzene International Symposium (venue for USEPA, EU and German MAK update) o review attendee list for potential follow-up o et extra ies of roceed m. BioI. M.Seliouk M. Todd/L. Russo Outreach Contacts M. Todd Technical Committee On-going On-going On-going On-going ongoing ILSI/HESI require formal presentation for Board consideration Int'l Childhood Leukemia Assoc. contactedawaiting response (Dr. Patricia Buffler) No contact with HEI Helmut Greim contacted to approach BP - on hold pending company-to- contact XOM complete BP outstanding Put on November agenda to review Updates will be posted to readsheet on website { FILENAME \p } Page 6 of 12 SH ELL-MCCLU RG-OS2S67 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 { FILENAME \p } Page 7 of 12 SH ELL-MCCLU RG-OS2S68 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 COMPLETED Action Items Schedule OC call to discuss funding sponsor recruitment and assign OC lead (8/26/04) Work with B. Jarnot to contact Peter Preuss (EPA) at 9/23/04 Naphthalene Coalition meeting (8/26/04) Work with L. Twerdok & B. Jarnot to develop agenda for October SRP/ERP call/mtg with T. Armstrong at the International Benzene Symposium (8/26/04) Make all approved changes to the amendment #2 and obtain API signatures. Two copies of the API signed amendment will then be sent to OC members for signature. (8/19/04) Responsible Party L. Twerdok S. Cagen & P. Beatty P. Beatty J. Wagner Circulate GCSP roster Update update OC action item table, and coordinate posting to website (8/19/04) Tabulate list of additional professional organizations for potential outreach - for OC discussion at the Nov. 3-4, 2004 meeting in Houston (8/19/04) Update 2004 Plan for Communications, Technical and Budget committees (8/19/04) Update yearly plan, and post updates to website (in consultation with respective committees) (8/19/04) Communicate consortium privileges to Marathon L. Twerdok L. Twerdok M. Todd M. Todd & B. Jarnot M. Todd, B. Jarnot &L. Twerdok L. Twerdok Status complete Comments Tentative: Monday, September 13; 2-3:30P (EDT) complete complete complete complete complete Those companies that did not sign amendment #1 (which changed the payment schedule for payment in 2003/early 2004 of all initially committed funds), amendment #1 will be sent along with amendment #2 for signature. complete complete complete Via email 8/30/04 { FILENAME \p } Page 8 of 12 SH ELL-MCCLU RG-OS2S69 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 _~ IPLETED Action Items Provide to L. Twerdok logistical information for November 3 - 4 OC meeting in Houston (8/19/04) Determine if an SHS update will be on the 10/19/04 HESGC agenda (8/19/04) Give Craig Parker of Marathon Ashland full access to SHS website (with the exception of the SRP/ERP areas, which no sponsor has access to) (8/19/04) Provide L. Twerdok detailed map of Shanghai, noting locations of hotels and Fudan University (8/19/04) Circulate link to NIH website on ethics training (8/26/04) Budget - Document with UCHSC that API requested interest for 2001,2002 and 2003 unspent funds and was denied, indicating that consortium still feels that it is owed this interest income send letter to UCHSC (4/21/04 & 6/21/04) 2004 Annual Meeting - Develop a robust closing session for the 2004 meeting (4/21/04) Responsible Party M. Johnston L. Twerdok M. Todd O. Wong L. Twerdok J. Wagner & B. Jarnot P. Clegg Status complete complete Complete Comments SHS update will NOT be on the agenda complete complete complete No back interest; will collect interest for 2004 forward complete { FILENAME \p } Page 9 of 12 SH ELL-MCCLU RG-052570 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 _~ IPLETED Action Items Circulate 2nd draft of consortium agreement amendment to OC for review (7/29/04) Add review of consortium agreement amendment to 8/16/040C meeting agenda (7/29/04) Find out date & location for fall HESGC meeting (7/29/04) Responsible Party J. Wagner L. Twerdok L. Twerdok Ensure active Outreach items covered on next PI call (6/21/04) 1Q04 financial report - case accrual sheet needs to be edited to clarify (6/21/04) Update Outreach Spreadsheet for distribution (6/21/04) Send details of pre-Asilomar OC meeting in San Francisco to Lorraine (6/21/04) Highlight meeting dates in email of minutes (6/21/04) Email summary of Downstream meeting and presentation to all consortium members (5/20/04) Add 2005 invoicing and consortium agreement amendment to agenda for June 21 OC call (5/20/04) Add P. Beatty to the CC roster on an interim basis until ChevronTexaco appoints a new, permanent member (5/20/04) Send email ballot to OC for decision on which API staff will attend Annual Meeting (5/20/04) Annual Meeting - Send out pre-meeting package with final agenda and meeting logistics and information on the Monterey area by July 15, 2004 (5/20/04) 2004 Annual Meeting - Set deadline (and communicate to presenters) for API receipt of presentations (5/20104) Develop a tracking spreadsheet to include a timeline for technical and regulatory outreach (5/20104) B. Jarnot B. Jarnot P. Clegg P. Beatty B. Jarnot P. Clegg L. Twerdok M. Todd L. Twerdok M Todd & M. Sellouk M. Todd & B. Jarnot L. Twerdok Status complete 7/30/04 complete 8/4/04 Complete 7/29/04 complete complete complete Complete 7/12/04 complete complete complete complete complete complete Comments Due 8/6/04 October 19, 2004 Pasadena, CA Passed along request for BHRC update to Howard Bruce, Lorraine, Madeleine & Matt to attend complete complete Deadline is August 1, 2004 Available on website { FILENAME \p } Page 10 of 12 SHELL-MCCLURG-052571 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 _~ IPLETED Action Items 1Q04 Financial Report - Clarify text summary and detail worksheet for case accruals with language provided on call (5/14/04) 1Q04 Financial Report - Reconcile bank balances with BHRC report and API financials (5/14/04) 1Q04 Financial Report - Circulate, via email, revised report for final OC approval once corrections made Put a 'no-cost time extension' amendment in place for APCO, to ensure that current contract does not expire while renewal issues are resolved (5/14/04) 2004 Annual Meeting - Circulate latest version of draft agenda 2004 Annual Meeting - Post list of attendees (and those not attending) to website (5/14/04) 2004 Annual Meeting - OC members to invite their appropriate company personnel, if not already invited (5/14/04) 2004 Annual Meeting - Cancel additional meeting room reserved for Wed. afternoon (5/14/04) 2004 Annual Meeting - On next monthly PI call, inform that the Annual Meeting will be a good opportunity to discuss outreach issues (5/14/04) 2004 Annual Meeting - Invite M. Sellouk to join June 21 conference Budget - Revise 4Q03 financial report as directed Budget - Find out interest income rates for API and UCHSC Outreach -Contact Pis to discuss outreach plans; Chinese Society Of Industrial Toxicology upcoming 9/04 meeting may be a good place to start, but who should give talk? PI or BHRC member? (next monthly call) (4/21/04) Outreach - request investigators to provide list of talks/abstracts/poster presentations of all SHS staff (on next Responsible Party L. Twerdok L. Twerdok L. Twerdok M. Todd M. Todd M. Todd OC M.Seliouk B. Jarnot M. Todd L. Twerdok B. Jarnot & L. Twerdok P. Beatty, S. Cagen, B. Jarnot P. Beatty, S. Cagen, B. Status complete Comments complete complete complete Circulated 6/3/04; approval pending complete complete complete complete complete on website on website complete complete complete complete Madeleine will join call API- 0.465% UCHSC - 0.837% complete { FILENAME \p } Page 11 of 12 SH ELL-MCCLU RG-OS2S72 BHRC OVERSIGHT COMMITTEE & COMMITTEE CHAIR CALL ACTION ITEM TABLE Last updated 11/5/04 _~ IPLETED Action Items monthly PI call) (4/21/04) Budget - Decision for 2005 sponsor invoicing needs to by made by June 2004 (4/21/04) Budget - Execute UCHSC grant payment (4/21/04) Outreach - build spreadsheet with actions, responsible party, and timelines for outreach plan (5/14/04) Outreach - obtain/circulate proceedings from previous Chinese Society Of Industrial Toxicology (5/14/04) 2004 Annual Meeting - Get an update on 2004 Annual Meeting logistics from Madeleine, and inform her of her action items (4/21/04) 2004 Annual Meeting - Find out if Dr. Fu will be giving a talk (4/21/04) 2004 Annual Meeting - Entertainment (karaoke) for the Tuesday evening opening reception (5/14/04) 2004 Annual Meeting - Arrange for conference room for Wed. PM PI/OC/TC meeting (4/21/04) Consortium Agreement - Develop amendment, circulate to Ad Hoc legal group for review, and circulate to companies for signature (4/21/04) Other -Schedule/announce upcoming OC meetings (August 1617 and November 3-4) and calls [May 14 @ 1 PM (eastern) (4/21/04)] Other - Schedule/announce Thursday May 6 Technical Committee call @1 PM (eastern) for 1Q04 financial report review. (4/21/04) Responsible Party Jarnot OC members B. Jarnot L. Twerdok Shan Tsai & P. Clegg M. Todd P. Beatty & TC B. Doll & M. Sellouk M.Seliouk J. Wagner L. Twerdok Bruce Status Comments Complete 6/21/04 complete Complete complete complete Agenda item for 6/21/04 call complete complete complete complete Dr. Fu will give short talk Decided to cancel concurrent meeting & room on 5/14/04 complete complete { FILENAME \p } Page 12 of 12 SH ELL-MCCLU RG-052573 11/8/03 draft BHRC OC Meeting Minutes November 3 & 4, 2004 Attendees Patrick Beatty, ChevronTexaco Don Burnett, BP Stuart Cagen, Shell Patsy Clegg, Shell Brian Doll, ExxonMobil Judy Elledge, ConocoPhillips Mike Johnston, ConocoPhillips Glenna Kyle, ExxonMobil Lynn Russo, ExxonMobil Howard Feldman, API Ed Murphy, API (11/3/04 only) Lorraine Twerdok, API By phone: John De Pasquale, ChevronTexaco Mark Fitzsimmons, Steptoe & Johnston John Wagner, API Antitrust guidelines reviewed and quorum established by L. Twerdok. Budget Discussion: Decision: 3Q04 financial report unanimously approved with one date correction to executive summary page. Decision: At API's request to facilitate distribution of funds, SRP/ERP contracts will be renewed annually by fund addition amendments. Decision: API will send out BHRC sponsor 2005 invoices on February 1,2005. This invoice will be for 1/3 of remaining company commitments. o ACTION - API to invoice companies 2/1/05 L. Twerdok presented M Bird's update on funding recruitment. ILSI/HESI contacted and require formal presentation to HESI Board in order to consider funding request. At least one OC and one Technical Committee member to attend. HEI has not been contacted. Attempting to make contact with International Childhood Leukemia Society o ACTION - M. Bird to get details (logistics, level of audience, etc.) to set up briefing Study budget reanalysis: Approximately $3.3 million of additional funds has been requested by the SHS investigators. The OC identified a 3-pronged approach to address this request: o reprogramming from existing committed sponsor funds, o supplementing funds from new and/or existing funding sponsors, and o the Technical Committee will work with Pis to explore potential cost efficiencies within this estimate of additional funds required to meet the goals of the study. E. Murphy, API Industry Operations & Downstream Group Director, reiterated that API is only the administrator for the BHRC, emphasizing that all consortium oversight, financial decisions and research activity oversight is the responsibility of the BHRC member companies. Additionally, API o does not have funds to contribute to the program, and o cannot expend funds beyond the funds available The preliminary plan developed to address the funding shortfall is summarized in table below. Budget Plan Action Items: OC members to recruit internal legal counsel SH ELL-MCCLU RG-OS2S74 11/8/03 draft XOM to host next SHS Annual Meeting in Fairfax, VA L. Twerdok to calculate savings for reducing remaining annual meeting from 3 to 2 B. Doll to contact M. Bird concerning reprogramming of QA/QC funds Technical Budget Committee to contact SHS principals for detailed budget re- analysis cost explanations for review to identify cost efficiencies B. Doll to arrange for Yimei Zhou of EMBSI to work full time on exposure assessment IH management in Shanghai L. Twerdok inform Madeleine that API will not be organizing 2005 annual meeting API inform all SHS participants of change in venue for 2005 annual meeting once ExxonMobil provides API with details Budget Action Plan Action Estimated Lead Amount ($K) Contact BP 1700 XOM &CVT APCO 250 L. Russo Legal 50 P. Clegg & G. Kyle Reduce annual meeting 3 --+ 2 65 OC CommiUee over next 3 years & hold in US QA/QC 100 Technical CmUe. Contingency 100 API revise budget Statisticians & database manager 100 Technical CmUe Case accrual schedule ? Technical CmUe acceleration Generate list of anticipated ? Technical CmUe publications ME case accrual ends when 200 ? Technical CmUe high exposure cases recruited (-1200 cases) EMBSI recruit full time exposure (800?) B. Doll expert (Yimei Zhou) Total $2450K Due Date (to API) 12/10/04 " " " " " " " " " " " " Joint Clinical & Molecular Laboratory (JCML) Sustainability Discussions: Sustainability expert Andrew Roberts (CoP) gave a brief overview of how to develop sustainability plans & projects, emphasizing that o the sponsors need a clear idea of the goals of the sustainability effort (function to be maintained, benefits of maintaining effort, funding requirements, etc), o a business plan needs to be developed by appropriate participants, and o communication strategies need to be developed for likely scenarios for the outcome of the sustainability plan. The OC identified several potential future uses/users of the JCML o Shanghai hospitals for clinical diagnostic work o Researchers for diagnostic and molecular capabilities (e.g. NCI), and further investigations with banked tissue samples SH ELL-MCCLU RG-052575 11/8/03 draft o Pharmaceutical/Biotech company use o "Safe Blood", which is an organization dedicated to ensure safe blood collection for transfusions. The organization will be expanding its program into China in the near future. Once Fudan makes decision for JCML to be managed by Fudan University or Fudan School of Public Health, BHRC (or 3rd party designee) should contact newly appointed JCML Director to facilitate development of laboratory business plan. ACTIONS Items: o Technical Committee to discuss with R. Irons if it would be useful for sponsor in-country representatives to meet with Fudan to emphasize importance of maintaining laboratory o L. Russo to contact APCO China for advice if/how BHRC can influence laboratory disposition decision by Fudan. Get advice by 12/04, for OC discussion in 1/05. o M. Johnston to draft strawman of transition plan goals for January OC meeting o OC to provide M. Johnston with in-house sustainable development contacts o OC to consider whether to involve NCI in JCML transition/sustainability, if NCI interested in following up as indicated at the 10/04 Int'I Benzene Symposium. o OC to meet in Houston (CoP) January 31 & February 1,2005 Technical Committee Update: P. Beatty presented an update on the October International Benzene Symposium o Meeting was data rich with interesting new data o SHS presentations were wellreceived. O. Wong presented the design of the case control study and R. Irons presented an overview of all studies and development of the laboratory. R. Irons then went on to review data from a subset of highly exposed workers. o NCI has expressed an interest in collaborating with AHS on future case control study in Shanghai As indicated in August, exposure information in Shanghai is less robust than originally indicated in the feasibility study. The case-control study will have a semiquantitative, rather than a full quantitative exposure assessment. Detailed exposure assessment update will be presented at next meeting. Next OC Meetings: Date: Thursday, December 16,2004 Time: 8:30 A - 5:00 P Location: API offices, Washington, DC Agenda items to include: o Budget revision o Outreach o Exposure update o Financial monitoring/audits o Site visit to JCML in Shanghai, since 2005 Annual Meeting will be in Fairfax, VA (Select OC & TC members, Jerry Rice, Paul Lombardo) o BHRC committee roles & responsibilities SH ELL-MCCLU RG-052576 11/8/03 draft o 2004 action item update o 2004 plan o preliminary 2005 plan Date: Monday, January 31 and Tuesday, February 1, 2005 Time: 1 - 5 P on Monday; 8 A - noon on Tuesday Location: Houston (hosted by CoP) Agenda items to include: o JCML transition Objective of transition plan Transition plan goals Potential laboratory sustainability outcomes, once SHS is complete SH ELL-MCCLU RG-OS2S77 From: Sent: To: Cc: Subject: Attach: Bruce Jamot <jamotb@api.org> Friday, November 12,20045:41 PM (GMT) benzconsort-tc@listserve.api.org Howard Feldman <Feldman@api.org>; Lorraine Twerdok <Twerdokl@api.org> BHRC-TC ... Support Documentation for CCIDPIME Study Budget Reanalyses UCHSC re-anal 1O-04.xls; AHS re-anal 1O-04.xls Benzene Health Research Consortium (BHRC) Technical Budget Committee - As described below, there is a significant difference between recent cost projections and the currently approved program budget. API has requested immediate guidance from the Oversight Committee to reconcile the difference between sponsor-committed funds and investigator cost projections. Subsequently, the Oversight Committee has asked the Technical Committee to address this issue by December 10 (providing an agenda for next week's BHRC-TC Conference Call, date/time TBD). Otto and Richard have provided the following information to elaborate and support budget reanalyses (see attached files) which they recently submitted: UCHSC Grant for DP & ME Studies I Dr. Richard Irons $17,336K following budget reanalysis $14,508K consortium-approved budget $.. 2,828K incremental costs According to Dr. Irons, UCHSC's budget reanalysis reflects 1) actual cash flow analysis during JCML operations to meet current work load and study requirements, versus pre-operational budget projections; 2) costs of competitive hires, primarily in China, to meet unexpected personnel requirements for completing Exposure Analysis activities; and 3) costs of increased EMBSI resource commitments required to complete the research as scoped, including an additional full-time industrial hygiene professional in the field. There are no duplicative costs relative to the CC study. Additional costs for 2007 data analysis were not elaborated further. Major activities associated with increased cost projections include: Analytic Chemistry -- All analytic chemistry operations have been established and study support functions embedded within JCML operations; these costs were not projected or anticipated within Fudan's operating budget, and includes reagents, small equipment, training and technical personnel. Exposure Analysis -- Significantly increased support for exposure analysis field work has been required; these costs were not anticipated within Fudan's projected operating budget, and beyond for hiring and supporting additional JCML staff or staff we hire directly to do the exposure analysis and supervise the field assessment work or to support EMBSI in doing the same Diagnostic Load -- the budget reanalysis reflects a realized 30% increase in case contact above pre-study projections, included within the Fudan University operating budget. The increased diagnostic load will allow 5-year case projections to be met in 3 years of JCML operation. AHS Contract for CC Study I Dr. Otto Wong $.. 2,732K following budget reanalysis $.. 2,283K consortium-approved budget $..... 449K incremental costs According to Dr. Wong, analysis of realized expenses compared to pre-study budget shows $449K of unanticipated incremental costs for the CC study (or $400K in constant 2004 dollars). This reanalysis does not duplicate activities associated with the DP or ME studies. Increases for 2005 and 2006 result from additional project supervision and for QA/QC required in Shanghai; this additional support was not anticipated within the projected CC operating budget, however, is vital to the success completion of the project based on observed progress and data quality to date. The increase fundamentally provides 3 additional weeks (120 hours) of professional time, plus travel-related costs for one additional trip to Shanghai during each of these 2 years. Completion of the CC study was initially planned for in 2006. Delays experienced early in all three studies shifted completion of data analysis, QAlQC review and report writing into the first half of 2007. The budget reanalysis includes funding for these 2007 activities. ************************************* With best regards - Bruce. SH ELL-MCCLU RG-052578 Case-control Study of AML and NHL Additioanl Budget Estimate for 2005, 2006 and 2007 A 1 2005 and 2006 2 Because of the need for much greater involvemnet of project supervision and QA/QC in Shanghai, we need to increase our level of effort. 3 Basically we have added 3 weeks of the PI's time and support from the others. We have also added one more trip to Shanghai in 2005 and 2006. 4 5 2007 6 Assuming that patient enrollment will be completed by end of 2006, we will be conducting final QA/QC, analysis and report writing in 2007. 7 At this moment, there is no budget for 2007 at all. An estimated budget is provided below. 8 9 10 Labor b~ categor~ 11 12 Category 13 Chief Epidemiologist (PI) 14 Biostatician 15 Statistical programmer 16 Research/Administration assistant 17 Consulting industrial hygienist 18 Total labor for regular activities (2004 $) 19 20 21 Meetings/working tri[!s (time & ex[!enses) 22 23 24 Meetings in China (10 days @) 25 Meetings in USA (3 days @) 26 Total for meetings/working trips (2004 $) 27 28 Total in 2004 $ (labor and trips) 29 30 31 Yearl~ budget estimates with a 5% annual adjustment 32 33 Budget by calendar year 34 Total (with 5% annual adjustment) 10/18/2004 BCDE Hourly rate in 2004 $ $324 $162 $139 $104 $232 2005 Hours Amount 120 $38,880 40 $6,480 20 $2,780 20 $2,080 20 $4,640 $54,860 Hours 120 40 20 20 20 Unit cost in 2004 $ $34,000 $10,500 2005 No. Amount 1 $34,000 0 $0 $34,000 $88,860 No. 1 0 Year 2005 $93,303 SH ELL-MCCLU RG-052579 F 1 2 3 4 5 6 7 8 9 10 11 12006 12 Amount 13 $38,880 14 $6,480 15 $2,780 16 $2,080 17 $4,640 18 $54,860 19 20 21 22 12006 23 Amount 24 $34,000 25 $0 26 $34,000 27 28 $88,860 29 30 31 32 33 Year 2006 34 $97,968 GH 2007 Hours Amount 200 $64,800 160 $25,920 180 $25,020 80 $8,320 40 $9,280 $133,340 2007 No. Amount 2 $68,000 2 $21,000 $89,000 $222,340 Year 2007 $257,386 IJ Total Hours Amount 440 $142,560 240 $38,880 220 $30,580 120 $12,480 80 $18,560 $243,060 Total No. Amount 4 $136,000 2 $21,000 $157,000 $400,060 Total $448,657 Case-control Study of AML and NHL Additioanl Budget Estimate for 2005, 2006 and 2007 10/18/2004 SH ELL-MCCLU RG-OS2S80 Projected Costs (2004-2006) A B C DE FG H 1 UCHSC Incremental Costs 2 Actual Expenditures as Through Through Through Through Through 3 of June 2004 Dec 2004 June 2005 Dec 2005 June 2006 Dec 2006 Subtotals 4 UCHSC $ 4,522,989 $519,801 $584,691 $590,489 $566,801 $483,327 $ 7,268,099 5 Fudan $ 1,774,199 $ 792,150 $ 763,836 $ 793,836 $ 794,389 $ 697,295 $ 5,615,706 6 IPHS $ 167,577 $ 6,000 $ 6,000 $ 6,000 $ -$ - $ 185,577 7 CDC $ 153,004 $ 5,000 $ -$ -$ -$ - $ 158,004 8 EMBSI $ 1,325,692 $ - $ 624,673 $ - $ 369,389 $ - $ 2,319,754 9 Children's $ 145,138 $ 84,225 $ 56,000 $ 56,000 $ 58,800 $ 58,800 $ 458,963 10 11 Projected Total $ 8,088,599 $1,407,176 $2,035,200 $1,446,325 $1,789,380 $1,239,422 $ 16,006,103 12 Current Budget $ 14,508,000 13 Incremental UCHSC Budget $ 1,498,103 14 15 16 EMBSllncremental Costs 17 Actual Expenditures as Through Through Through Through Through 18 of June 2004 Dec 2004 June 2005 Dec 2005 June 2006 Dec 2006 Subtotals 19 Projected Total $ 1,325,692 $ - $ 743,748 $ 119,075 $ 488,464 $ 119,075 $ 2,796,054 20 Current Budget $ 2,319,754 21 Incremental EMBSI Costs $ 476,300 &[FILE]Project Budget &[DATE] SH ELL-MCCLU RG-OS2S81 Report of Expenditures A 1 University of Colorado Health Sciences Center 2 3 Office of 4 Grants and Contracts 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 B Title of Project: Project Director: Reporting Period: UCHSC Account Number: Grant Period: Total Amount of Grant: Expenditures: &[FILE]2004-2005 report C Personnel: Total Personnel: Operating Expenses Total Operating Expenses: Sub Contracts: &[DATE] SH ELL-MCCLU RG-OS2S82 Report of Expenditures D E F GH 1 2 3 4 5 6 7 8 9 10 REPORT OF EXPENDITURES 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Personnel at UCHSC: $ 32 Other: 33 $ 34 35 Expendable Supplies: 36 Non-capital Equipment: 37 Services 38 Maintenance: 39 ME feasibility Study: 40 Contingency: 41 $ 42 43 Fudan University (1) $ 44 IPHSC (2) $ University Hospitals School of Medicine School of Nursing School of Dentistry API Leuk/Lymph Project Richard Irons 1/112004 to 06130/04 2555312 04/01/01 to 12/31/04 $9,263,820.00 Grant Budget to Date Expenditures as of 12/31/03 "urren, enou Expenditure as of 06/30/04 Accumulative Actuals to date 06/30/04 1,696,871 1,696,871 1,683,743 - $1,255,819 $ $3,900 $ $1,259,719 $ $310,525 $ $145,923 $ $115,707 $ $6,161 $ $1,560 $ $43,330 $ $623,207 $ $1,284,814 $ $159,894 $ 211,016 $ -$ 211,016 $ 412,552 (40) 23,475 (45) 3,600 - 439,542 $ $ $ $ $ $ $ 489,385 $ 7,683 $ 1,466,836 3,900 1,470,736 723,077 145,883 139,182 6,116 5,160 43,330 1,062,748 1,774,199 167,577 &[FILE]2004-2005 report &[DATE] SH ELL-MCCLU RG-OS2S83 Report of Expenditures 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 $ 32 33 $ 34 35 36 37 38 39 40 41 $ 42 43 44 I JK Budget Balance Available 3-Month Actuals for 7/1/04 to 9/30/04 Acluals for 7/01/04 to 12/31/04 230,035.34 -$3,900 226,135.34 $ 620,994.48 $ $ $ $ 115,936.00 $ 161,028.00 $ $ $ $ $ $ $ 345,275.00 $ $ - - - - - L MN Project to Date Expenditures on 12/31104 Budgeted for Grant Period 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 &[FILE]2004-2005 report &[DATE] SH ELL-MCCLU RG-OS2S84 Report of Expenditures 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 Administrative Officer: 64 A B Total Expenditures: c Total Sub Contracts: Travel: Equipment: Total Equipment: Indirect Costs: Total Indirect Costs: &[FILE]2004-2005 report &[DATE] SH ELL-MCCLU RG-052585 Report of Expenditures 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 Mary O'Connell D SMCDCP (3) $ EMBSI (5) $ Children's Hospital (Cincinnati) (6) $ $ $ Capital Equipment: $ Shipping/importation $ Overhead: $ Other: $ $ E - 3,627,756 32,000 1,291,150 1,291,150 932,300 932,300 9,263,820 F $150,504 $ $726,725 $ $115,166 $ $2,437,103 $ $9,098 $ $1,191,150 $ $ $1,191,150 $ $523,312 $ $ $523,312 $ $6,043,589 $ G 2,500 598,967 29,972 1,128,507 $ $ $ $ -$ 117,340 $ - 117,340 $ 167,979 $ - 167,979 $ 2,064,384 $ H 153,004 1,325,692 145,138 3,565,610 9,098 1,308,491 1,308,491 691,291 691,291 8,107,974 &[FILE]2004-2005 report &[DATE] SH ELL-MCCLU RG-OS2S86 Report of Expenditures 45 46 47 48 $ 49 50 $ 51 52 53 54 $ 55 56 57 58 $ 59 60 61 $ 62 63 64 I $ 62,146.11 $ 22,901.53 $ (17,340.44) $ 241,009.42 $ 1,155,846.44 $ J $ $ 49,477.00 $ 394,752.00 $ - $ 75,000.00 $ $ 71,353.00 $ 818,069.00 K - - - - - - 0.00 L MN 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 &[FILE]2004-2005 report &[DATE] SH ELL-MCCLU RG-OS2S87 Post-Study Analysis (Jan 2007 - June 2007) AB 1 2 Jan 2007 - June 2007 3 4 UCHSC $ 406,114 5 EMBSI $ 407,700 6 Cincinnati Children's Hospital $ 39,295 7 8 Total $ 853,109 C &[FILE]Post-Study Analysis &[DATE] SH ELL-MCCLU RG-OS2S88 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Thursday, November 11, 2004 7:53 PM (GMT) benzconsort-tc@listserve.api.org Howard Feldman <Feldman@api.org> BHRC-TC... Reply Needed by COB Fri 11112 - Date/Time for next ConfCall 2004 11-3-04 OC min. doc; 2004 OC Action Item Table 11-05-04.doc Benzene Health Research Consortium (BHRC) Technical Committee - Attached are Lorraine's draft minutes from last week's (Nov 3-4) Oversight Committee meeting in Houston, along with an updated table of "action items"; as you'll see, a fair number of new action items fall to the Technical Committee (TC) and to the Technical Budget Committee (TBC). ** Note that all action items need to be completed by Friday, December 10th (ref: action item #3), so that resolution of each be readied for discussion at the upcoming December 16th OC meeting *** Given the quick turnaround request by the OC, Patrick suggested that we convene a conference call next week to 1) provide a short team de-brief of the recent Houston OC meeting, 2) to review progress to date on any open action items, and 3) to develop plans to complete the remaining action items. PLEASE REPLY BY COB FRIDAY (tomorrow) as to which of these dates & start times work best with your schedule: Nov 15 (Mon), 9:00am Eastern / 6:00am Pacific Nov 15 (Mon), 5:00pm Eastern / 2:00pm Pacific Nov 18 (Thurs), 2:00pm Eastern / 11 :OOam Pacific Nov 18 (Thurs), 4:00pm Eastern / 1:OOpm Pacific Nov 19 (Fri), 9:00am Eastern / 6:00am Pacific Nov 19 (Fri), 2:00pm Eastern / 1:OOpm Pacific Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org -----Original Message----From: Lorraine Twerdok Sent: Wednesday, November 10, 20049:57 AM To: Benzene OC listserve (E-mail) Subject: BHRC - 11/3 draft minutes for review BHRC OC Members - Attached please find draft minutes and updated action item table from the Nov. 3/4 meeting in Houston. Comments are due Monday, November 29. SH ELL-MCCLU RG-OS2S89 200411-3-04 OC min.doc 2004 OC Action Item Table 11-05-04.doc Regcwds, La VYCl LV\,e Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 email: twerdokl@api.org fax: 202-682-8031 SH ELL-MCCLU RG-OS2S90 From: Sent: To: Subject: Matt Todd <ToddM@api.org> Monday, May 2,20058:05 PM (GMT) BHRC Oversight Committee (E-mail) <benzconsort-oc@listserve.api.org>; BHRC Technical Committee (E-mail) <benzconsort-tc@listserve.api.org>; BHRC Communications Committee (E-mail) <benzconsort-cc@listserve.api.org> Shanghai Health Study Update: May 2,2005 Shanghai Health Study Update Announcements: Attention: The conference call number has changed to 707.765.9147. The participant code is 2026828319, followed by the # sign. The Oversight Committee will be meeting tomorrow (May 3, 2005) at API in Washington, DC. The draft agenda for the meeting is posted on the SHS Update page. The final minutes from the April 11th and 12th Oversight Committee meetings in Houston have been posted on the Oversight page. The Oversight Committee Action Table has been updated and is posted on the SHS Update page. The Finance Committee met by conference call on April 5th to review the 4Q04 Finance Report and April 29th to review the 1Q05 Finance Report. The Technical Committee met by conference call on April 8th to approve the 4Q04 Finance Report and April 29th to approve the 1Q05 Finance Report. The Technical Committee met for a conference call on April 13th with Otto Wong. The Technical Committee is scheduling May conference calls with Drs. Krieger, Wong, and Irons. If you have any announcements that you would like to be posted, please send an email to Matt Todd. Matthew Todd Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005 p: (202)682-8319 f: (202)682-8031 www.api.org SHELL-MCCLURG-052591 From: Sent: To: Cc: Subject: Bruce Jarnot <jarnotb@api.org> Monday, May 2,20057:57 PM (GMT) benzconsort-tc@listserve.api.org Matt Todd (E-mail)<matthewatodd@netzero.com> BHRC-TC... Shanghai PIs - Generic Titles for 2006 Presentations Benzene Health Research Consortium (BHRC) Technical Committee - "Generic titles" for 2006 plenary presentation by Shanghai-based Pis, which may be suitable for invitation letters to facilitate obtaining Chinese travel visas ... Fu Hua ... Advances in Exposure Assessment for the Shanghai Health Study You-Xin Liang ... Reconstruction of Occupational Exposure in the Shanghai Health Study Best Regards - Bruce. -----Original Message----From: Bruce Jarnot Sent: Wednesday, April 27, 2005 5: 19 PM To: benzconsort-tc@listserve.apLorg Cc: Michael Bird (E-mail) Subject: BHRC-TC... Pis Review by Fri 4/29: draft 2005 plenary session titles Benzene Health Research Consortium (BHRC) Technical Committee - The BHRC-OC recently tasked the TC to draft titles for plenary session presentations at the 2005 SHS annual meeting. ACTION - please review attached 1-page word document, which provides you with a "first draft" speaker line-up 1draft presentation titles 1draft presentation themes for discussion & revision during the 11 :OOam EDT conference call on Friday 4/29 Thanks, and best regards - Bruce. SH ELL-MCCLU RG-OS2S92 From: Sent: To: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Friday, April 29, 2005 2: 17 PM (GMT) Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org> BHRC - 4120 budget summary BHRC rev budget 4-20-05.xls; UCRSC 2005 - 2007 budget summary - LT.xls BHRC rev budget 4-20-05.xls UCHSC 2005 - 2007 budget summary - LT.xls Regcwds, La VYCl LV\,e ***************************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 email: twerdokl@api.org fax: 202-682-8031 SH ELL-MCCLU RG-OS2S93 A 1 2 3 4 5 6 7 UCHSC Proposed Pmt Schedule 8 9 EMBSI subcontract increases 10 11 Fudan subcontract increases (new) 12 13 Histology consultant* 14 15 Cincinnati Children's Hospital** 16 17 less UCHSC 12/31104 bank balance 18 19 20 TOTALS 21 Current Payment Schedule 22 Proposed increase 23 24 25 26 27 28 * Histology consultant included since this service is a subcontract for the DP/ME studies. 29 30 31 ** 2007 costs for Cincinnati Children's Hospital did not appear to be included in Jan 2005 progress report figures Page 1 of 12 4/20105 SH ELL-MCCLU RG-OS2S94 B 1 UCHSC Projected expenses 2005 - 2007 to include subcontractor increases 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Payment for 2006 & 2007 should be made directly to Dr. Bennett by UCHSC (2005 pmt already made by API) 30 31 C DE 2005 $3,374,030 $238,150 $159,600 $0 $3,771,780 $1,748,060 Current UCHSC Program Budget Proposed budget increase Proposed UCHSC Program Budget Page 2 of 12 4/20105 SH ELL-MCCLU RG-052595 FG H 1 2 (draft) 3 4 2006 2007 TOTALS 5 6 7 $2,682,280 $406,114 $6,462,424 8 9 $562,550 $407,700 $1,208,400 10 11 $159,600 $159,600 $478,800 12 13 $3,000 $3,000 $6,000 14 15 $0 $39,295 $39,295 16 17 18 19 20 $3,407,430 $1,015,709 $8,194,919 21 $1,748,060 $874,030 $4,370,150 22 $3,824,769 23 24 $14,508,000 25 $3,824,769 26 $18,332,769 27 28 29 30 31 IJK L API revised payment schedule Apr-05 $874,030 Oct-05 $2,750,000 Apr-05 $2,500,000 Oct-06 $1,500,000 Feb-07 $570,889 Total $8,194,919 UCHSC 1105 proposed schedule 2 Apr-05 $874,030 Oct-05 $2,500,000 Apr-05 $1,750,000 Oct-06 $932,280 Feb-07 $406,114 Total $6,462,424 Page 3 of 12 4/20105 SH ELL-MCCLU RG-OS2S96 A 1 2 3 4 5 6 7 UCHSC Expenses 8 9 EMBSI subcontract expenses 10 11 Fudan subcontract expenses 12 13 Histology consultant expenses' 14 15 Cincinnati Children's Hospital expenses" 16 17 IPHS expenses 18 19 UCHSC 12/31104 bank balance (subtract from expense projections for 2005 payment to UCHSC 20 21 Projected Expense Totals 2005-2007 22 23 Current Payment Schedule/budget 24 25 Total budget increase 26 Total paid to UCHSC as of 12/31104 27 Revised UCHSC program budget 28 29 30 Histology consultant included since this service is a subcontract for the DP/ME studies. 31 32 33 2007 costs for Cincinnati Children's Hospital did not appear to be included in Jan 2005 progress report figures Page 4 of 12 4/20/05 SH ELL-MCCLU RG-OS2S97 B 1 UCHSC Projected expenses 2005 - 2007 and Revised Program Budget 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Payment for 2006 & 2007 should be made by UCHSC (2005 pmt already made by API) 32 33 C DE FG H (draft) 2005 2006 2007 TOTALS $1,217,148 $1,108,178 $406,114 $2,731,440 $ 862,823 $ 931,939 $ 407,700 $2,202,462 $1,676,855 $1,651,285 $159,600 $3,487,740 $3,000 $3,000 $6,000 $112,000 $117,600 $39,295 $268,895 $12,000 $0 $0 $12,000 (513,618) ($513,618) $3,367,208 $3,812,002 $1,015,709 $8,194,919 $1,748,060 $1,748,060 $874,030 $4,370,150 $1,619,148 $2,063,942 $141,679 $3,824,769 $10,137,850 $18,332,769 I Page 5 of 12 4/20105 SH ELL-MCCLU RG-OS2S98 JK L 1 2 3 4 5 API revised payment schedule 6 Apr-05 $874,030 7 Oct-05 $2,750,000 8 Apr-06 $2,500,000 9 Oct-06 $1,500,000 10 Feb-07 $570,889 11 Total $8,194,919 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Page 6 of 12 4/20105 SH ELL-MCCLU RG-OS2S99 AB 1 UCHSC 2005 - 2007 Increase by Category 2 3 4 5 6 7 UCHSC increases 8 9 EMBSI subcontract increases 10 11 Fudan subcontract increases (new) 12 13 Histology consultant* 14 15 Cincinnati Children's Hospital** 16 17 TOTALS 18 19 * Histology consultant included since this service is a subcontract for the DP/ME studies. 20 Payment for 2006 & 2007 should be made by UCHSC (2005 pmt already made by API) 21 22 ** 2007 costs for Cincinnati Children's Hospital did not appear to be included in Jan 2005 progress report figures Page 7 of 12 4/20105 SH ELL-MCCLU RG-OS2600 C 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 DE (draft) 2005 F 2006 GH 2007 TOTALS $843,080 $843,080 $406,114 $2,092,274 $238,150 $562,550 $407,700 $1,208,400 $159,600 $159,600 $159,600 $478,800 $0 $3,000 $3,000 $6,000 $0 $0 $39,295 $39,295 $1,240,830 $1,568,230 $1,015,709 $3,824,769 Page 8 of 12 4/20105 SHELL-MCCLURG-052601 A BC D EF 1 UCHSC Projected Expenses for 2005 - 2007 2 does NOT INCLUDE subcontractor increases (EMBSI, Fudan, Cincinnati & Bennett) 3 (from January 2005 Progress Report) 4 (draft) 5 6 7 Personnel 8 Operating Expenses 9 Subcontracts' 10 Travel 11 Equipment 12 Indirect 13 14 Totals 15 16 17 Amount for 2005-2007 UCHSC disbursement Funds at UCHSC as of 12/31/04 2005 Expenses $463,610 $501,380 $2,286,533 $1,000 $0 $251,158 2006 Expenses $482,144 $396,360 $1,958,069 $1,000 $0 $228,674 2007 Expenses $203,265 $0 $150,000 $0 $0 $52,849 ($513,618) $3,503,681 $3,066,247 $406,114 G Totals $1,149,019 $897,740 $4,394,602 $2,000 $0 $532,681 $6,462,424 $6,462,424 Page 9 of 12 4/20105 SH ELL-MCCLU RG-052602 A 1 2 B CD E FGH I EMBSI Incremental Costs (draft) 3 4 Actual Expenditures as Through Through Through Through Through Through 5 of June 2004 Dec 2004 June 2005 Dec 2005 June 2006 Dec 2006 2007 Subtotals 6 Projected Total $ 1,325,692 $ - $ 743,748 $ 119,075 $ 488,464 $ 119,075 $ 407,700 $ 3,203,754 7 2006 Yimei Zhou costs $ 324,400 $ 324,400 8 Totals $ 1,325,692 $ 743,748 $ 119,075 $ 812,864 $ 119,075 $ 407,700 $ 3,528,154 9 $- 10 Current Budget $ 1,325,692 $ - $ 624,673 $ - $ 369,389 $ - $ 2,319,754 11 $ - 12 EMBSI Increases $ - $ 119,075 $ 119,075 $ 443,475 $ 119,075 $ 407,700 $ 1,208,400 13 14 15 Increased costs by year $ 238,150 $ 562,550 $ 407,700 $ 1,208,400 16 17 Total cost per year $ 862,823 $ 931,939 $ 407,700 $ 2,202,462 Page 10 of 12 4/20105 SH ELL-MCCLU RG-052603 AB C D E FG H 1 FUDAN Subcontract to UCHSC: 2005 - 2007 Increases 2 (as submitted to API by R. Schnatter on 4/7/05) 3 (draft) 4 5 $ 50,000 To extend Dr. Ni's contract to locate MD phase 1 and 2 factories 6 (a) contract expired 3/31105, and additional factories need to be recruited 7 8 $ 25,000 For additional western-based expert review of job exposure matrix 9 (a) retain funds in "contingency" for EA effort? 10 (b) apply to EMBSI sub-contract? 11 12 $ 135,200 For 4 additional Shanghai-based EA staff (US $16,900/year) x 2 years 13 (b) one additional staff to work with IPHS to extract data from IPHS database; 14 (c) two additional skilled staff (with leadership skills) for field work; 15 (d) one factory liaison (from district IPHS office) to work with municipal IPHS for factory recruitment 16 17 $ 45,000 For additional Factory Access (based on experience to date, US $1 K - 2.5K per factory) 18 (a) 15 factories for Phase 1 ($1 K) 19 (b) 12 factories for Phase 2 (2.5K) 20 21 $ 100,000 For 8 Chinese industry experts (e.g. printing, painting, rubber) 22 (a) 1OOK = 8 x $50/hr x 125 hrlyear x 2 years 23 (b) Note: this represents a 4x decrease from Dr. Fu's earlier proposed requirement 24 25 $ 56,000 To further engage district IPHS offices 26 (a) district offices are administratively separate from Municipal IPHS 27 (b) funds provided to Municipal IPHS was not further distributed to district offices 28 29 $ 67,600 For two EA liaisons, to facilitate ex-Shanghai IPHS $ factory communications 30 (a) 67.6K = 2 liaisons x 2 years x US$16,900/year 31 32 $ 478,800 Total 33 34 Payment Schedule - split equally over the three years at $159,600 per year Page 11 of 12 4/20105 SH ELL-MCCLU RG-052604 IJK 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 Page 12 of 12 4/20105 SH ELL-MCCLU RG-052605 Benzene Health Reseach Consortium Budget as of April 20, 2005 A BC D E FG H 1 2 BHRC Overall Program Budget Approved April 12, 2005 3 (draft) 4 5 Approved Approved Requested 16 Dec 04 OC Increase 12 APR 05 OC 6 Item mtg APRIL 05 mtg 7 UCHSC DP & ME Studies $14,508,000 $3,824,769 $18,332,769 8 Irons (field expenses) $1,413,428 $0 $1,413,428 9 AHSciences Case-Control Study $2,283,095 $647,746 $2,930,841 10 Fudan University $230,000 $76,062 $306,062 11 Total Research Costs $18,434,523 $4,548,577 $22,983,100 12 Scientific Review Panel $300,000 $0 $300,000 13 Ethics Review Panel $64,000 $0 $64,000 14 External Pathology & Cytogenetics Workgroups(Cost in UC cost) $0 $0 $0 15 Total Panel Costs $364,000 $364,000 16 API Seed Monies $0 $0 $0 17 Outside Counsel $100,000 $40,000 $140,000 18 Public Affairs $300,000 $0 $300,000 19 QAJQC Activities $50,000 $0 $50,000 20 UCHSC Interest $0 $0 $0 21 contingency $590,272 $260,000 $850,272 22 Miscellaneous Costs $1,040,272 $300,000 $1,340,272 23 Subtotal $19,838,795 $4,848,577 $24,687,372 24 API Admin.' $1,245,205 $200,000 $1,445,205 25 GRAND TOTAL $21,084,000 $5,048,577 $26,132,577 26 27 * API administrative costs for one extra year (2007) 28 Page 1 of 15 4/20105 SH ELL-MCCLU RG-052606 Benzene Health Research Consortium Program Budget as of April 20, 2005 A 1 2 3 4 5 6 7 Cost Centers 8 9 Income 10 interest thru 12/31104 11 TOTAL INCOME 12 13 Cost Centers 14 UCHSC 15 Irons-Field Expense 16 Applied Health Sciences 17 Fudan University 18 Scientific & Ethics Panels 19 Communications 20 Outside Legal Counsel 21 QA/QC Support 22 API Administrative 23 Contingency** 24 25 Total Expenses 26 27 Fund Balance'" 28 29 totals may be off due to rounding 30 31 *ConocoPhillips paid full amend #2 in 2005: BP pay full remaining commitment in 2005 32 **not zero out because a mix of actual and estimated expenses match proposed budget difference due to a mix of actual vs projected expenses 33 *** Fund balance as of 12/31104 reflects program interest to date. Interest for years 2005-2007 is not reflected due to changing rates. B C DE BHRC Proje Project # Cumulative Actuals Inception Thru 4Q04 Proposed 2005' 16,715,000 50,692 16,765,692 4,395,097 X8105 X8106 X8107 X8108 X8109 X8103 X8104 X8110 X8100 10,137,850 788,486 1,391,014 124,090 166,772 294,161 64,529 0 871,150 104,473 13,942,525 2,823,167 3,367,208 262,000 534,843 80,563 79,250 1,946 30,031 16,667 184,995 159,933 4,717,436 2,500,828 Page 2 of 15 4/20105 SH ELL-MCCLU RG-052607 FG H I 1 ""2 ted Expenses and Income Requirements 3 (draft) 4 5 Prior 12 APR 05 6 Proposed Proposed Program Program 7 2006 2007 Budget Budget 8 9 3,500,000 1,522,480 21,084,000 26,132,577 10 11 12 13 14 3,812,002 1,015,709 14,508,000 18,332,769 15 262,000 104,714 1,413,428 1,413,428 16 548,231 456,475 2,283,095 2,930,841 17 55,490 45,918 230,000 $306,061 18 74,250 47,396 364,000 364,000 19 1,946 1,946 300,000 300,000 20 30,031 30,032 100,000 140,000 21 16,667 16,667 50,000 50,000 22 184,995 200,000 1,245,205 1,445,205 23 222,933 362,933 590,272 $850,272 24 25 5,208,545 2,281,790 21,084,000 26,132,576 26 27 792,283 32,973 ** 28 29 30 31 32 33 Benzene Health Research Consortium Program Budget as of April 20, 2005 Page 3 of 15 4/20105 SH ELL-MCCLU RG-052608 Benzene Health Consortium Budget as of April 20, 2005 1 2 3 4 Member 2- ~ A BC D Consortium Agreement Amendment #3 Schedule A (draft) Original Budget Amendment No.2 Amendment No.3 $16,500,000 Revised Budget $21,084,000 Additional Member Contributions1 7 """"8 9 BP 10 ChevronTexaco 11 ConocoPhillips 12 ExxonMobil 13 Shell 14 Marathon3 15 16 GRAND TOTAL' 17 18 19 20 1 BP's increased contribution reflects $1,644,000 for amendment no. 2 plus $924,430 21 for amendment no. 3. 22 2 The share distribution has reverted back to the allocation specified in original agreement 23 3 Marathon was invoiced for its contribution, and is not a signatory of this agreement. 24 Marathon's earlier payment of $15,000 was not reflected in previous calculations. 25 ' Totals reflect rounding $4,500,000 3,000,000 1,500,000 4,500,000 3,000,000 15,000 $16,515,000 $4,500,000 4,096,000 2,048,000 6,144,000 4,096,000 200,000 $21,084,000 $2,568,430 616,287 308,143 924,430 616,287 0 $5,033,577 EF Program Total Revised Budget $26,135,577 Maximum Financial Contribution per Member Amount Paid as of 12/31104' $7,068,430 4,712,287 2,356,143 7,068,430 4,712,287 215,000 $4,500,000 3,000,000 1,500,000 4,500,000 3,000,000 215,000 $26,132,577 $16,715,000 Page 4 of 15 4/20105 SH ELL-MCCLU RG-052609 G 1 2 3 4 5 H 6 Remaining Original # Amount to be of Shares Paid 7 8 9 $2,568,430 3 10 1,712,287 2 11 856,143 1 12 2,568,430 3 13 1,712,287 2 14 0 -- 15 16 9,417,577 11 17 18 19 20 21 22 23 24 25 Benzene Health Consortium Budget as of April 20, 2005 Page 5 of 15 4/20105 SHELL-MCCLURG-052610 Benzene Health Research Consortium Budget as of April 20, 2005 A BC DE FG 1 Sponsor Shares and Payment Schedule 2 (draft) 3 4 Approved Increase by Share & Co. 5 Approved Increase $5,048,577 less BP amend #2 amt 6 & MAP $15K* ($1,659,000) amend 3 share 7 calculation total $3,389,577 Amena :.! 8 commitment 9 1 share $308,143 $4,500,000 10 2 shares $616,287 $4,096,000 11 3 shares $924,430 $2,048,000 12 $6,144,000 13 BP (amend. 2 + new) $2,568,430 $4,096,000 14 Chevron Texaco $616,287 15 ConocoPhillips $308,143 Total 16 ExxonMobil $924,430 Marathon 17 Shell $616,287 Grand Total 18 19 Total $5,033,577 20 *MAP $15K seed money included in share 21 calculation resulting in a reduction of $1366 per 22 share 23 24 Sponsor Potential Payment Schedule 25 2005 2006 2007 Total 26 BP $2,568,430 $0 $0 $2,568,430 BP 27 CVX $365,333 $911,959 $434,994 $1,712,286 CVX 28 COP* $548,000 $308,143 $0 $856,143 COP 29 XOM* $548,000 $1,367,939 $652,492 $2,568,431 XOM 30 Shell $365,333 $911,959 $434,994 $1,712,286 Shell 31 $4,395,096 $3,500,000 $1,522,480 $9,417,576 32 33 2005 pmt schedule unchanged from current schedule except for BP 34 * 2005 commitment paid as of 3/31105 35 36 H lotal Commitments $7,068,430 $4,712,287 $2,356,143 $7,068,430 $4,712,287 $25,917,577 $215,000 $26,132,577 Calc Amend 2 $0 $1,096,000 $548,000 $1,644,000 $1,096,000 $4,384,000 Paid through 200 MAP contribution Page 6 of 15 4/20105 SHELL-MCCLURG-052611 I 1 2 3 4 5 J 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 lation checks 25 Amend 3 26 $2,568,430 27 $616,287 28 $308,143 29 $924,430 30 $616,287 31 $5,033,577 32 33 34 35 36 Program Total Total $2,568,430 $1,712,287 $856,143 $2,568,430 $1,712,287 $9,417,577 $16,500,000 $215,000 $26,132,577 Benzene Health Research Consortium Budget as of April 20, 2005 Page 7 of 15 4/20105 SHELL-MCCLURG-052612 Benzene Health REsearch Consortium Budget as of April 20, 2005 A 1 2 3 4 5 6 7 UCHSC Expenses 8 9 EMBSI subcontract expenses 10 11 Fudan subcontract expenses 12 13 Histology consultant expenses' 14 15 Cincinnati Children's Hospital expenses" 16 17 IPHS expenses 18 19 UCHSC 12/31104 bank balance (subtract from expense projections for 2005 payment to UCHSC 20 21 Projected Expense Totals 2005-2007 22 23 Current Payment Schedule/budget 24 25 Total budget increase 26 Total paid to UCHSC as of 12/31104 27 Revised UCHSC program budget 28 29 30 Histology consultant included since this service is a subcontract for the DP/ME studies. 31 32 33 2007 costs for Cincinnati Children's Hospital did not appear to be included in Jan 2005 progress report figures Page 8 of 15 4/20/05 SHELL-MCCLURG-052613 Benzene Health REsearch Consortium Budget as of April 20, 2005 B 1 UCHSC Projected expenses 2005 - 2007 and Revised Program Budget 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Payment for 2006 & 2007 should be made by UCHSC (2005 pmt already made by API) 32 33 C DE FG H (draft) 2005 2006 2007 TOTALS $1,217,148 $1,108,178 $406,114 $2,731,440 $ 862,823 $ 931,939 $ 407,700 $2,202,462 $1,676,855 $1,651,285 $159,600 $3,487,740 $3,000 $3,000 $6,000 $112,000 $117,600 $39,295 $268,895 $12,000 $0 $0 $12,000 (513,618) ($513,618) $3,367,208 $3,812,002 $1,015,709 $8,194,919 $1,748,060 $1,748,060 $874,030 $4,370,150 $1,619,148 $2,063,942 $141,679 $3,824,769 $10,137,850 $18,332,769 I Page 9 of 15 4/20105 SHELL-MCCLURG-052614 JK L 1 2 3 4 5 API revised payment schedule 6 Apr-05 $874,030 7 Oct-05 $2,750,000 8 Apr-06 $2,500,000 9 Oct-06 $1,500,000 10 Feb-07 $570,889 11 Total $8,194,919 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Benzene Health REsearch Consortium Budget as of April 20, 2005 Page 10 of 15 4/20105 SHELL-MCCLURG-052615 A 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Benzene Health Research Consortium Budget as of April 20, 2005 BC UCHSC increases EMBSI subcontract increases Fudan subcontract increases (new) Histology consultant* Cincinnati Children's Hospital** TOTALS * Histology consultant included since this service is a subcontract for the DP/ME studies. ** 2007 costs for Cincinnati Children's Hospital did not appear to be included in Jan 2005 progress Page 11 of 15 4/20105 SHELL-MCCLURG-052616 Benzene Health Research Consortium Budget as of April 20, 2005 D 1 UCHSC 2005 - 2007 Increase by Category 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Payment for 2006 & 2007 should be made by UCHSC (2005 pmt already made by API) 21 22 eport figures E FG H I J (draft) 2005 2006 2007 TOTALS $843,080 $843,080 $406,114 $2,092,274 $238,150 $562,550 $407,700 $1,208,400 $159,600 $159,600 $159,600 $478,800 $0 $3,000 $3,000 $6,000 $0 $0 $39,295 $39,295 $1,240,830 $1,568,230 $1,015,709 $3,824,769 Page 12 of 15 4/20105 SHELL-MCCLURG-052617 Benzene Health Research Consortium Budget as of April 20, 2005 A 1 AHS Case Control Expense Projections 2 3 2005 and 2006 4 Because of the need for much greater involvemnet of project supervision and QAJQC in Shanghai, we need to increase our level of effort. 5 Basically we have added 3 weeks of the PI's time and support from the others. We have also added one more trip to Shanghai in 2005 and 2006. 6 7 2007 8 Assuming that patient enrollment will be completed by end of 2006, final diagnoses and patient interviews completed by March 2007 and exposure assessment 9 completed by May-June 2007,we will be doing the following tasks in June-September 2007: final QAJQC, statistical analysis, presentations, discussuion with 10 Scientific Review Panel and Technical Committee, and report writing. 11 At this moment, there is no budget for 2007 at all. An estimated budget for 2007 is provided below. 12 13 14 Labor b~ categor~ 15 16 Category 17 Chief Epidemiologist (PI) 18 Biostatician 19 Statistical programmer 20 Research/Administration assistant 21 Consulting industrial hygienist 22 Total labor for regular activities (2004 $) 23 24 25 Meetings/working tri[!s (time & ex[!enses) 26 27 28 Meetings in China (10 days @) 29 Meetings in USA (3 days @) 30 Total for meetings/working trips (2004 $) 31 32 Total in 2004 $ (labor and trips) 33 34 35 Yearl~ budget estimates with a 5% annual adjustment 36 37 Additional budget by calendar year 38 Total additional budget (with 5% annual adjustment) 39 + original 40 TOTAL REVISED AHS BUDGET 41 BC Hourly rate in 2004 $ $324 $162 $139 $104 $232 Hours 120 40 20 20 20 Unit cost in 2004 $ $34,000 $10,500 No. 1 0 2004 439,242 439,242 Page 13 of 15 4/20/05 SHELL-MCCLURG-052618 Benzene Health Research Consortium Budget as of April 20, 2005 D 1 2 (draft) 3 4 5 6 7 8 9 10 11 12 13 14 15 005 16 Amount 17 $38,880 18 $6,480 19 $2,780 20 $2,080 21 $4,640 22 $54,860 23 24 25 26 005 27 Amount 28 $34,000 29 $0 30 $34,000 31 32 $88,860 33 34 35 36 37 Year 2005 38 $93,303 39 441,540 40 534,843 41 EF 2006 Hours Amount 120 $38,880 40 $6,480 20 $2,780 20 $2,080 20 $4,640 $54,860 2006 No. Amount 1 $34,000 0 $0 $34,000 $88,860 Year 2006 $97,968 450,263 548,231 GH 2007 Hours Amount 400 $129,600 320 $51,840 360 $50,040 160 $16,640 100 $23,200 $271,320 2007 No. Amount 3 $102,000 2 $21,000 $123,000 $394,320 Year 2007 $456,475 0 456,475 IJ Total Hours Amount 640 $207,360 400 $64,800 400 $55,600 200 $20,800 140 $32,480 $381,040 Total No. Amount 5 $170,000 2 $21,000 $191,000 $572,040 Total $647,746 $1,331,045 $1,978,791 1,978,791 Page 14 of 15 4/20105 SHELL-MCCLURG-052619 A 1 2 3 4 5 Blue: Fudan budget reanalysis, through 2Q 2007 6 7 Labor (time) 8 9 Category 10 Physician epidemiologist 11 Data Handler 12 Total labor (US$) 13 14 Exeenses 15 16 Fee for Shanghai CDC staff 17 Fee for AML patients 18 Fee for NHL patients 19 Hospital coordinators 20 Fee for controls 21 Fee for NHL hospital coordination 22 Fee for office supplies 23 Transportation for local and long distance 24 Total expenses (US$) 25 26 New Exgenses 27 Add transport for annual mtgs 28 29 sub total 30 5% Annual increase 31 Overhead Fee (15%) 32 33 Grand Total 34 Current 35 Increase 36 37 38 [*Annual Salary includes salary, bonus and benefits.] 39 40 41 42 43 Benzene Health Research Consortium Budget as of April 20, 2005 B C D E F G HIJ K L Fudan University Case Control Revised Expense Projections (contracted directly with API) (draft) Annual Salary* US$ 16,900 5,850 Unit cost 30 30 30 30 2004 52,170 2005 (Year 5) Time Amount 0.15 2,535 1.20 7,020 9,555 No. Amount 6,000 150 4,500 150 4,500 150 4,500 600 18,000 5,000 1,800 1,200 45,500 15,000 70,055 0 10,508 80,563 58,356 22,207 2006 (Year 6) Time Amount 0.25 4,225 1.16 6,786 11,011 2007 (half-year) Time Amount 0.15 1,268 1.20 3,510 4,778 No. Amount 3,000 130 3,900 130 3,900 130 3,900 460 13,800 5,000 1,700 1,200 36,400 No. Amount 1,500 65 1,950 65 1,950 65 1,950 230 6,900 2,500 900 600 18,250 0 47,411 2,371 5,709 55,490 49,015 6,475 15,000 38,028 1,901 5,989 45,918 45,918 Yrs 2005-2007 (est) Yrs 2001-2004 (act.) Revised est. budget 11/03 budget budget increase $181,972 $124,090 $306,062 $230,000 $76,062 Total 8,028 17,316 25,344 Total 10,500 10,350 10,350 10,350 38,700 12,500 4,400 3,000 100,150 30,000 155,494 4,272 22,207 181,972 159,541 22,431 Page 15 of 15 4/20105 SH ELL-MCCLU RG-052620 From: Sent: To: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Friday, April 29, 200S S:19 PM (GMT) Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org> BHRC rev budget 4-20-0S.xls BHRC rev budget 4-20-0S.xls BHRC rev budget 4-20-0S.xls Revised budget worksheet with AHS worksheet detailing the $6481< increases added. -Lorraine SHELL-MCCLURG-052621 Benzene Health Reseach Consortium Budget as of April 20, 2005 A BC D E FG H 1 2 BHRC Overall Program Budget Approved April 12, 2005 3 (draft) 4 5 Approved Approved Requested 16 Dec 04 OC Increase 12 APR 05 OC 6 Item mtg APRIL 05 mtg 7 UCHSC DP & ME Studies $14,508,000 $3,824,769 $18,332,769 8 Irons (field expenses) $1,413,428 $0 $1,413,428 9 AHSciences Case-Control Study $2,283,095 $647,746 $2,930,841 10 Fudan University $230,000 $76,062 $306,062 11 Total Research Costs $18,434,523 $4,548,577 $22,983,100 12 Scientific Review Panel $300,000 $0 $300,000 13 Ethics Review Panel $64,000 $0 $64,000 14 External Pathology & Cytogenetics Workgroups(Cost in UC cost) $0 $0 $0 15 Total Panel Costs $364,000 $364,000 16 API Seed Monies $0 $0 $0 17 Outside Counsel $100,000 $40,000 $140,000 18 Public Affairs $300,000 $0 $300,000 19 QAJQC Activities $50,000 $0 $50,000 20 UCHSC Interest $0 $0 $0 21 contingency $590,272 $260,000 $850,272 22 Miscellaneous Costs $1,040,272 $300,000 $1,340,272 23 Subtotal $19,838,795 $4,848,577 $24,687,372 24 API Admin.' $1,245,205 $200,000 $1,445,205 25 GRAND TOTAL $21,084,000 $5,048,577 $26,132,577 26 27 * API administrative costs for one extra year (2007) 28 Page 1 of 17 4/20105 SH ELL-MCCLU RG-OS2622 Benzene Health Research Consortium Program Budget as of April 20, 2005 A 1 2 3 4 5 6 7 Cost Centers 8 9 Income 10 interest thru 12/31104 11 TOTAL INCOME 12 13 Cost Centers 14 UCHSC 15 Irons-Field Expense 16 Applied Health Sciences 17 Fudan University 18 Scientific & Ethics Panels 19 Communications 20 Outside Legal Counsel 21 QA/QC Support 22 API Administrative 23 Contingency** 24 25 Total Expenses 26 27 Fund Balance'" 28 29 totals may be off due to rounding 30 31 *ConocoPhillips paid full amend #2 in 2005: BP pay full remaining commitment in 2005 32 **not zero out because a mix of actual and estimated expenses match proposed budget difference due to a mix of actual vs projected expenses 33 *** Fund balance as of 12/31104 reflects program interest to date. Interest for years 2005-2007 is not reflected due to changing rates. B C DE BHRC Proje Project # Cumulative Actuals Inception Thru 4Q04 Proposed 2005' 16,715,000 50,692 16,765,692 4,395,097 X8105 X8106 X8107 X8108 X8109 X8103 X8104 X8110 X8100 10,137,850 788,486 1,391,014 124,090 166,772 294,161 64,529 0 871,150 104,473 13,942,525 2,823,167 3,367,208 262,000 534,843 80,563 79,250 1,946 30,031 16,667 184,995 159,933 4,717,436 2,500,828 Page 2 of 17 4/20105 SH ELL-MCCLU RG-052623 FG H I 1 ""2 ted Expenses and Income Requirements 3 (draft) 4 5 Prior 12 APR 05 6 Proposed Proposed Program Program 7 2006 2007 Budget Budget 8 9 3,500,000 1,522,480 21,084,000 26,132,577 10 11 12 13 14 3,812,002 1,015,709 14,508,000 18,332,769 15 262,000 104,714 1,413,428 1,413,428 16 548,231 456,475 2,283,095 2,930,841 17 55,490 45,918 230,000 $306,061 18 74,250 47,396 364,000 364,000 19 1,946 1,946 300,000 300,000 20 30,031 30,032 100,000 140,000 21 16,667 16,667 50,000 50,000 22 184,995 200,000 1,245,205 1,445,205 23 222,933 362,933 590,272 $850,272 24 25 5,208,545 2,281,790 21,084,000 26,132,576 26 27 792,283 32,973 ** 28 29 30 31 32 33 Benzene Health Research Consortium Program Budget as of April 20, 2005 Page 3 of 17 4/20105 SH ELL-MCCLU RG-OS2624 Benzene Health Consortium Budget as of April 20, 2005 1 2 3 4 Member 2- ~ A BC D Consortium Agreement Amendment #3 Schedule A (draft) Original Budget Amendment No.2 Amendment No.3 $16,500,000 Revised Budget $21,084,000 Additional Member Contributions1 7 """"8 9 BP 10 ChevronTexaco 11 ConocoPhillips 12 ExxonMobil 13 Shell 14 Marathon3 15 16 GRAND TOTAL' 17 18 19 20 1 BP's increased contribution reflects $1,644,000 for amendment no. 2 plus $924,430 21 for amendment no. 3. 22 2 The share distribution has reverted back to the allocation specified in original agreement 23 3 Marathon was invoiced for its contribution, and is not a signatory of this agreement. 24 Marathon's earlier payment of $15,000 was not reflected in previous calculations. 25 ' Totals reflect rounding $4,500,000 3,000,000 1,500,000 4,500,000 3,000,000 15,000 $16,515,000 $4,500,000 4,096,000 2,048,000 6,144,000 4,096,000 200,000 $21,084,000 $2,568,430 616,287 308,143 924,430 616,287 0 $5,033,577 EF Program Total Revised Budget $26,135,577 Maximum Financial Contribution per Member Amount Paid as of 12/31104' $7,068,430 4,712,287 2,356,143 7,068,430 4,712,287 215,000 $4,500,000 3,000,000 1,500,000 4,500,000 3,000,000 215,000 $26,132,577 $16,715,000 Page 4 of 17 4/20105 SH ELL-MCCLU RG-052625 G 1 2 3 4 5 H 6 Remaining Original # Amount to be of Shares Paid 7 8 9 $2,568,430 3 10 1,712,287 2 11 856,143 1 12 2,568,430 3 13 1,712,287 2 14 0 -- 15 16 9,417,577 11 17 18 19 20 21 22 23 24 25 Benzene Health Consortium Budget as of April 20, 2005 Page 5 of 17 4/20105 SH ELL-MCCLU RG-052626 Benzene Health Research Consortium Budget as of April 20, 2005 A BC DE FG 1 Sponsor Shares and Payment Schedule 2 (draft) 3 4 Approved Increase by Share & Co. 5 Approved Increase $5,048,577 less BP amend #2 amt 6 & MAP $15K* ($1,659,000) amend 3 share 7 calculation total $3,389,577 Amena :.! 8 commitment 9 1 share $308,143 $4,500,000 10 2 shares $616,287 $4,096,000 11 3 shares $924,430 $2,048,000 12 $6,144,000 13 BP (amend. 2 + new) $2,568,430 $4,096,000 14 Chevron Texaco $616,287 15 ConocoPhillips $308,143 Total 16 ExxonMobil $924,430 Marathon 17 Shell $616,287 Grand Total 18 19 Total $5,033,577 20 *MAP $15K seed money included in share 21 calculation resulting in a reduction of $1366 per 22 share 23 24 Sponsor Potential Payment Schedule 25 2005 2006 2007 Total 26 BP $2,568,430 $0 $0 $2,568,430 BP 27 CVX $365,333 $911,959 $434,994 $1,712,286 CVX 28 COP* $548,000 $308,143 $0 $856,143 COP 29 XOM* $548,000 $1,367,939 $652,492 $2,568,431 XOM 30 Shell $365,333 $911,959 $434,994 $1,712,286 Shell 31 $4,395,096 $3,500,000 $1,522,480 $9,417,576 32 33 2005 pmt schedule unchanged from current schedule except for BP 34 * 2005 commitment paid as of 3/31105 35 36 H lotal Commitments $7,068,430 $4,712,287 $2,356,143 $7,068,430 $4,712,287 $25,917,577 $215,000 $26,132,577 Calc Amend 2 $0 $1,096,000 $548,000 $1,644,000 $1,096,000 $4,384,000 Paid through 200 MAP contribution Page 6 of 17 4/20105 SH ELL-MCCLU RG-OS2627 I 1 2 3 4 5 J 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 lation checks 25 Amend 3 26 $2,568,430 27 $616,287 28 $308,143 29 $924,430 30 $616,287 31 $5,033,577 32 33 34 35 36 Program Total Total $2,568,430 $1,712,287 $856,143 $2,568,430 $1,712,287 $9,417,577 $16,500,000 $215,000 $26,132,577 Benzene Health Research Consortium Budget as of April 20, 2005 Page 7 of 17 4/20105 SH ELL-MCCLU RG-052628 Benzene Health REsearch Consortium Budget as of April 20, 2005 A 1 2 3 4 5 6 7 UCHSC Expenses 8 9 EMBSI subcontract expenses 10 11 Fudan subcontract expenses 12 13 Histology consultant expenses' 14 15 Cincinnati Children's Hospital expenses" 16 17 IPHS expenses 18 19 UCHSC 12/31104 bank balance (subtract from expense projections for 2005 payment to UCHSC 20 21 Projected Expense Totals 2005-2007 22 23 Current Payment Schedule/budget 24 25 Total budget increase 26 Total paid to UCHSC as of 12/31104 27 Revised UCHSC program budget 28 29 30 Histology consultant included since this service is a subcontract for the DP/ME studies. 31 32 33 2007 costs for Cincinnati Children's Hospital did not appear to be included in Jan 2005 progress report figures Page 8 of 17 4/20/05 SH ELL-MCCLU RG-052629 Benzene Health REsearch Consortium Budget as of April 20, 2005 B 1 UCHSC Projected expenses 2005 - 2007 and Revised Program Budget 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Payment for 2006 & 2007 should be made by UCHSC (2005 pmt already made by API) 32 33 C DE FG H (draft) 2005 2006 2007 TOTALS $1,217,148 $1,108,178 $406,114 $2,731,440 $ 862,823 $ 931,939 $ 407,700 $2,202,462 $1,676,855 $1,651,285 $159,600 $3,487,740 $3,000 $3,000 $6,000 $112,000 $117,600 $39,295 $268,895 $12,000 $0 $0 $12,000 (513,618) ($513,618) $3,367,208 $3,812,002 $1,015,709 $8,194,919 $1,748,060 $1,748,060 $874,030 $4,370,150 $1,619,148 $2,063,942 $141,679 $3,824,769 $10,137,850 $18,332,769 I Page 9 of 17 4/20105 SH ELL-MCCLU RG-OS2630 JK L 1 2 3 4 5 API revised payment schedule 6 Apr-05 $874,030 7 Oct-05 $2,750,000 8 Apr-06 $2,500,000 9 Oct-06 $1,500,000 10 Feb-07 $570,889 11 Total $8,194,919 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Benzene Health REsearch Consortium Budget as of April 20, 2005 Page 10 of 17 4/20105 SH ELL-MCCLU RG-OS2631 A 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Benzene Health Research Consortium Budget as of April 20, 2005 BC UCHSC increases EMBSI subcontract increases Fudan subcontract increases (new) Histology consultant* Cincinnati Children's Hospital** TOTALS * Histology consultant included since this service is a subcontract for the DP/ME studies. ** 2007 costs for Cincinnati Children's Hospital did not appear to be included in Jan 2005 progress Page 11 of 17 4/20105 SH ELL-MCCLU RG-OS2632 Benzene Health Research Consortium Budget as of April 20, 2005 D 1 UCHSC 2005 - 2007 Increase by Category 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Payment for 2006 & 2007 should be made by UCHSC (2005 pmt already made by API) 21 22 eport figures E FG H I J (draft) 2005 2006 2007 TOTALS $843,080 $843,080 $406,114 $2,092,274 $238,150 $562,550 $407,700 $1,208,400 $159,600 $159,600 $159,600 $478,800 $0 $3,000 $3,000 $6,000 $0 $0 $39,295 $39,295 $1,240,830 $1,568,230 $1,015,709 $3,824,769 Page 12 of 17 4/20105 SH ELL-MCCLU RG-OS2633 Benzene Health Research Consortium Budget as of April 20, 2005 A 1 AHS Case Control Expense Projections 2 3 2005 and 2006 4 Because of the need for much greater involvemnet of project supervision and QAJQC in Shanghai, we need to increase our level of effort. 5 Basically we have added 3 weeks of the PI's time and support from the others. We have also added one more trip to Shanghai in 2005 and 2006. 6 7 2007 8 Assuming that patient enrollment will be completed by end of 2006, final diagnoses and patient interviews completed by March 2007 and exposure assessment 9 completed by May-June 2007,we will be doing the following tasks in June-September 2007: final QAJQC, statistical analysis, presentations, discussuion with 10 Scientific Review Panel and Technical Committee, and report writing. 11 At this moment, there is no budget for 2007 at all. An estimated budget for 2007 is provided below. 12 13 14 Labor b~ categor~ 15 16 Category 17 Chief Epidemiologist (PI) 18 Biostatician 19 Statistical programmer 20 Research/Administration assistant 21 Consulting industrial hygienist 22 Total labor for regular activities (2004 $) 23 24 25 Meetings/working tri[!s (time & ex[!enses) 26 27 28 Meetings in China (10 days @) 29 Meetings in USA (3 days @) 30 Total for meetings/working trips (2004 $) 31 32 Total in 2004 $ (labor and trips) 33 34 35 Yearl~ budget estimates with a 5% annual adjustment 36 37 Additional budget by calendar year 38 Total additional budget (with 5% annual adjustment) 39 + original 40 TOTAL REVISED AHS BUDGET 41 BC Hourly rate in 2004 $ $324 $162 $139 $104 $232 Hours 120 40 20 20 20 Unit cost in 2004 $ $34,000 $10,500 No. 1 0 2004 439,242 439,242 Page 13 of 17 4/20/05 SH ELL-MCCLU RG-OS2634 Benzene Health Research Consortium Budget as of April 20, 2005 D 1 2 (draft) 3 4 5 6 7 8 9 10 11 12 13 14 15 005 16 Amount 17 $38,880 18 $6,480 19 $2,780 20 $2,080 21 $4,640 22 $54,860 23 24 25 26 005 27 Amount 28 $34,000 29 $0 30 $34,000 31 32 $88,860 33 34 35 36 37 Year 2005 38 $93,303 39 441,540 40 534,843 41 EF 2006 Hours Amount 120 $38,880 40 $6,480 20 $2,780 20 $2,080 20 $4,640 $54,860 2006 No. Amount 1 $34,000 0 $0 $34,000 $88,860 Year 2006 $97,968 450,263 548,231 GH 2007 Hours Amount 400 $129,600 320 $51,840 360 $50,040 160 $16,640 100 $23,200 $271,320 2007 No. Amount 3 $102,000 2 $21,000 $123,000 $394,320 Year 2007 $456,475 0 456,475 IJ Total Hours Amount 640 $207,360 400 $64,800 400 $55,600 200 $20,800 140 $32,480 $381,040 Total No. Amount 5 $170,000 2 $21,000 $191,000 $572,040 Total $647,746 $1,331,045 $1,978,791 1,978,791 Page 14 of 17 4/20105 SH ELL-MCCLU RG-052635 A 1 2005 and 2006 2 Because of the need for much greater involvemnet of project supervision and QAJQC in Shanghai, we need to increase our level of effort. 3 Basically we have added 3 weeks of the PI's time and support from the others. We have also added one more trip to Shanghai in 2005 and 2006. 4 5 2007 6 Assuming that patient enrollment will be completed by end of 2006, final diagnoses and patient interviews completed by March 2007 and exposure assessment 7 completed by May-June 2007,we will be doing the following tasks in June-September 2007: final QAJQC, statistical analysis, presentations, discussuion with 8 Scientific Review Panel and Technical Committee, and report writing. 9 At this moment, there is no budget for 2007 at all. An estimated budget for 2007 is provided below. 10 11 12 Labor b~ categor~ 13 14 Category 15 Chief Epidemiologist (PI) 16 Biostatician 17 Statistical programmer 18 Research/Administration assistant 19 Consulting industrial hygienist 20 Total labor for regular activities (2004 $) 21 22 23 Meetings/working tri[!s (time & ex[!enses) 24 25 26 Meetings in China (10 days @) 27 Meetings in USA (3 days @) 28 Total for meetings/working trips (2004 $) 29 30 Total in 2004 $ (labor and trips) 31 32 33 Yearl~ budget estimates with a 5% annual adjustment 34 35 Additional budget by calendar year 36 Total additionasl budget (with 5% annual adjustment) BC Hourly rate in 2004 $ $324 $162 $139 $104 $232 Hours 120 40 20 20 20 Unit cost in 2004 $ $34,000 $10,500 No. 1 0 SH ELL-MCCLU RG-OS2636 D 1 2 3 4 5 6 7 8 9 10 11 12 13 2005 14 Amount 15 $38,880 16 $6,480 17 $2,780 18 $2,080 19 $4,640 20 $54,860 21 22 23 24 2005 25 Amount 26 $34,000 27 $0 28 $34,000 29 30 $88,860 31 32 33 34 35 Year 2005 36 $93,303 EF 2006 Hours Amount 120 $38,880 40 $6,480 20 $2,780 20 $2,080 20 $4,640 $54,860 2006 No. Amount 1 $34,000 0 $0 $34,000 $88,860 Year 2006 $97,968 GH 2007 Hours Amount 400 $129,600 320 $51,840 360 $50,040 160 $16,640 100 $23,200 $271,320 2007 No. Amount 3 $102,000 2 $21,000 $123,000 $394,320 Year 2007 $456,475 IJ Total Hours Amount 640 $207,360 400 $64,800 400 $55,600 200 $20,800 140 $32,480 $381,040 Total No. Amount 5 $170,000 2 $21,000 $191,000 $572,040 Total $647,746 SH ELL-MCCLU RG-OS2637 A 1 2 3 4 5 Blue: Fudan budget reanalysis, through 2Q 2007 6 7 Labor (time) 8 9 Category 10 Physician epidemiologist 11 Data Handler 12 Total labor (US$) 13 14 Exeenses 15 16 Fee for Shanghai CDC staff 17 Fee for AML patients 18 Fee for NHL patients 19 Hospital coordinators 20 Fee for controls 21 Fee for NHL hospital coordination 22 Fee for office supplies 23 Transportation for local and long distance 24 Total expenses (US$) 25 26 New Exgenses 27 Add transport for annual mtgs 28 29 sub total 30 5% Annual increase 31 Overhead Fee (15%) 32 33 Grand Total - reanalysis 34 Current (12/04 projections) 35 Increase 36 37 38 [*Annual Salary includes salary, bonus and benefits.] 39 **accrued, not expensed yet 40 41 42 43 Benzene Health Research Consortium Budget as of April 20, 2005 B C D E F G HIJ K L Fudan University Case Control Revised Expense Projections (contracted directly with API) (draft) Annual Salary* US$ 16,900 5,850 Unit cost 30 30 30 30 2004 52,170 ** 2005 (Year 5) Time Amount 0.15 2,535 1.20 7,020 9,555 No. Amount 6,000 150 4,500 150 4,500 150 4,500 600 18,000 5,000 1,800 1,200 45,500 15,000 70,055 0 10,508 80,563 58,356 22,207 2006 (Year 6) Time Amount 0.25 4,225 1.16 6,786 11,011 2007 (half-year) Time Amount 0.15 1,268 1.20 3,510 4,778 No. Amount 3,000 130 3,900 130 3,900 130 3,900 460 13,800 5,000 1,700 1,200 36,400 No. Amount 1,500 65 1,950 65 1,950 65 1,950 230 6,900 2,500 900 600 18,250 0 47,411 2,371 5,709 55,490 49,015 6,475 15,000 38,028 1,901 5,989 45,918 45,918 Yrs 2005-2007 (est) Yrs 2001-2004 (act.) Revised est. budget 11/03 budget budget increase $181,972 $124,090 $306,062 $230,000 $76,062 Total 8,028 17,316 25,344 Total 10,500 10,350 10,350 10,350 38,700 12,500 4,400 3,000 100,150 30,000 155,494 4,272 22,207 181,972 159,541 22,431 Page 17 of 17 4/20105 SH ELL-MCCLU RG-OS2638 From: Sent: To: Cc: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Sunday, April 24, 2005 3:56 PM (GMT) Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org> Bruce Jarnot <jarnotb@api.org>; Lorraine Twerdok <Twerdokl@api.org> BHRC IQ05 fina rpt for review/approval BHRC Program Expenses 1Q05 rpt DRAFT.xls To BHRC Budget Committee: Attached is the final draft of the 1Q05 financial report for your review & approval. Note that your comments are required on the Text Summary page. I would like to put this on the May 3rd OC agenda for approval, so Bruce will be contacting you shortly to set up a call for the week of April 25. Regcwds, ***************************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 email: twerdokl@api.org fax: 202-682-8031 SH ELL-MCCLU RG-OS2639 Benzene Health Research Consortium 1Q05 Financial Report Overview A BC D E FG 1 2 RESEARCH PROGRESS: 3 Case Diagnosis: JCML clinical lab continues to increase diagnostic throughput, operating well above 100% capacity, processing 30% more cases than anticipated with 99+% concordance between 4 secondary 1tertiary pathology review. 5 Case Accrual: Cases are being accrued at optimal rate from all participating hospitals, with 500+ AML and 400+ NHL anticipated by end of study. As of 4Q04, 687 confirmed cases were entered int 6 External Review Panels: Panels reviewing progress reports, manuscripts and presentations as these documents become available. 7 8 EXPENSE DISCUSSION: 9 10 Fund Balance at API 4Q04: $3,672,133 DR 11 Irons Field EXl2enses: New T&E contract executed in 4Q04; $131 K disbursed in 1Q05. 12 UCHSC: Contract amendment executed with UCHSC; $874,030 additional was disbursed 4Q04, for a total $2.62MM disbursed in 2004. Increased spending rate & total expenditures reflect marked i 13 Subcontracts: 4Q04 subcontractor expenses include Fudan Univ ($880K) and Children's Hosp ($68K); no additional '04 EMBSI charges, front-loaded for the year. 14 AHS: Travel expenses have stayed under budget, but high labor costs due to time spent in Shanghai have now put AHS $46K (3%) over budget. [Jan/Feb expenses annualize to $19K (5%) under b 15 Fudan Universit~:{ Additional case load, and transfer of CDC & IPHS activities has increased rate of expenditure; sufficient funds were not budgeted for travel to annual meetings (-10K/yr). 16 SRP/ERP: Total expenses remain under budget as of year end 2004. Consortium should consider unanticipated additional expenses in out-years, if expert panels are to be retained post-study for ma 17 Communications (APCO): program budget reduced to $300K ($250K to contingency) 18 19 Outside Legal Council: cummulative variance of 28% over budget 20 21 QAlQC: program budget reduced to $50K ($50K to contgency) 22 23 Contingenc~: increased by $300K ($250K from communicaitons; $50K from QA/QC). 24 25 API Administrative Costs: 0.5 % over budger 26 27 FORWARD GUIDANCE: 28 29 SRPIERP projected expenses need to be re-analyzed to reflect new meeting venue and possibly reduced number of meetings (3 to 2). 30 31 UCHSC grant requires close monitoring due to large 2004 expenses and new case-based cost structure 32 33 Irons Field EXl2enses: new T&E contract in place. 34 35 Fudan Universit~: new contract should be executed in 1Q04. 36 37 API administrative expenses requires close monitoring to contain costs. Projected expenses for 2005 will require a substantial decrease in API staff time. Budget projections were based on the assum 38 39 Need to reconcile UCHSC statement - they have a $105 error (from 4Q03 rpt). 40 41 Technical Budget Work Group Acceptance: 42 Oversight Committee Acceptance: 43 Posted to Website: 44 45 46 LT 4/24/05 47 BJ 4/05/05 Page 1 of41 &[DATE] SH ELL-MCCLU RG-052640 HI 1 2 ~ rimary diagnosis & 4 5 the database, including 6 7 8 9 10 ~FT 11 12 crease in JCML case 13 14 dget for 2005.] 15 16 nuscript review and other 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 tion that API staffing 38 39 40 41 42 43 44 45 46 47 Benzene Health Research Consortium 1Q05 Financial Report Overview Page 2 of41 &[DATE] SH ELL-MCCLU RG-OS2641 A 1 2 Item 3 AHSciences Case-Control Study 4 DP & ME Studies (UCHSC) 5 Irons(T & E) 6 Fudan University 7 8 Scientific Review Panel 9 Ethics Review Panel 10 External Pathology & Cytogenetics Workgroups(Cost in UC cost) 11 12 API Seed Monies 13 Outside Counsel 14 Public Affairs 15 QAJQC Activities 16 UCHSC Interest 17 contingency 18 19 20 21 GRAND TOTAL 22 23 Notes by API 24 Notes/Assumptions for Dec. 2001 revised budget: 25 26 27 28 29 LT 4/24/05 Benzene Health Research Consortium Approved Program Budget 1Q05 Financial Report B Total Research Costs Total Panel Costs Miscellaneous Costs Subtotal API Admin. C Original Cost D Approved Revised Cost Estimate (Jan. Estimate (Dec. 2001) 2001) $1,595,000 $13,665,017 $1,253,428 $165,700 $16,679,145 $450,000 $500,000 $1,000,000 $2,283,095 $15,258,017 $1,253,428 $190,555 $18,985,095 $648,000 $216,000 $130,000 $994,000 $0 $500,000 $1,000,000 $225,000 $190,855 $1,690,855 $18,820,000 $941,000 $19,761,000 $0 $1,725,000 $21,704,095 $1,085,205 $22,789,300 E Unapproved Changes not approved (June 2003) $2,283,095 $15,258,000 $1,597,273 $661,000 $19,799,368 $551,736 $192,000 $0 $743,736 $0 $100,576 $960,600 $100,000 $0 $1,161,176 $21,704,280 $1,085,019 $22,789,299 F Approved 11 NOV 03 OC mtg $2,283,095 $14,508,000 $1,413,428 $230,000 $18,434,523 $300,000 $64,000 $0 $364,000 $0 $100,000 $550,000 $100,000 ($100,000) $390,272 $1,040,272 $19,838,795 $1,245,205 $21,084,000 G Approved 21 APR 04 OC mtg $2,283,095 $14,508,000 $1,413,428 $230,000 $18,434,523 $300,000 $64,000 $0 $364,000 $0 $100,000 $550,000 $100,000 $0 $290,272 $1,040,272 $19,838,795 $1,245,205 $21,084,000 H Approved 16 Dec 04 OC mtg $2,283,095 $14,508,000 $1,413,428 $230,000 $18,434,523 $300,000 $64,000 $0 $364,000 $0 $100,000 $300,000 $50,000 $0 $590,272 $1,040,272 $19,838,795 $1,245,205 $21,084,000 - The total research costs have changed as a result of the - Panel costs assume that there will be only one face-to-face meeting for each panel each year. DRAFT Page 3 of41 &[DATE] SH ELL-MCCLU RG-OS2642 Benzene Health Research Consortium Executive Summary 1Q05 Financial Report A BC DE F G H 1 2 ~ 4 DRAFT 5 Inception Thru Actuals Actuals Cumulative Actuals 6 7 Cost Centers Project # December 2004 Jan - Mar 2005 Program to Date Inception Thru 1Q05 8 9 Income $ 16,765,693 $ 1,096,000 $ 17,861,693 $ 17,861,693 10 11 12 Cost Centers 13 UCHSC* 14 Irons-Field Expense* X8105 X8106 10,137,850 788,486 - 131,000 10,137,850 919,486 10,137,850 919,486 15 Applied Health Sciences 16 Fudan University 17 Scientific & Ethics Panels 18 Communications X8107 X8108 X8109 X8103 1,391,014 124,090 166,772 294,161 70,316 - 1,461,330 124,090 166,772 294,161 1,461,330 124,090 166,772 294,161 19 Outside Legal Counsel 20 QAJQC Support X8104 X8110 64,529 - 4,827 - 69,356 - 69,356 - 21 API Administrative 22 Contingency** X8100 871,150 104,473 37,396 3,496 908,546 107,969 908,546 107,969 23 24 Total Expenses $ 13,942,525 $ 247,035 $ 14,189,560 $ 14,189,560 25 26 Fund Balance $ 2,823,169 $ 848,965 $ 3,672,133 27 28 29 blue is projected fund balanced to project when current funds will run out 30 * amount disbursed by API 31 32 ** $300K added to contingency; $250K from Communicaitons & $50K 33 from QAJQC 34 *** ConocoPhillips pay remaining commitment in 2005 35 LT 4/24/05 36 37 38 I J K LM Budget (actual + projected incom 2005 $ 1,826,667 *** 2006 $ 1,278,667 1,748,060 131,000 331,400 21,861 74,500 1,946 12,524 12,500 93,980 162,933 $ 2,590,704 $ 2,908,096 1,748,060 262,000 449,985 29,148 71,000 1,946 16,698 16,667 123,200 162,933 $ 2,881,637 $1,305,126 Page 4 of 41 &[DATE] SH ELL-MCCLU RG-052643 N 0P Q 1 2 3 & expenses) 4 5 6 Projected Program 7 2007 Expenses Budget 8 9$ 1,278,667 $ 22,245,694 $ 21,084,000 10 11 12 13 874,030 14,508,000 14,508,000 14 104,714 1,417,200 1,413,428 15 45,833 2,288,549 2,283,095 16 29,148 204,247 230,000 17 44,000 356,272 364,000 18 1,946 300,000 300,000 19 16,698 115,276 100,000 20 16,667 45,833 50,000 21 123,200 1,248,926 1,245,205 22 159,933 593,768 590,272 23 24 $ 1,416,169 $ 21,078,070 $ 21,084,000 25 26 $1,167,624 27 28 29 30 31 Income Detail 32 sponsors $17,596,000 33 2001 seed $15,000 34 MAP contrib. $200,000 35 API interest $50,692 36 UCHSC interest $0 37 38 TOTAL $17,861,692 Benzene Health Research Consortium Executive Summary 1Q05 Financial Report Page 5 of 41 &[DATE] SH ELL-MCCLU RG-OS2644 Benzene Health Research Consortium Case Accrual 1Q05 A Case Accrual (Case Predictions) ~ ReDorted Cumulativelv ~ AML (120/yr.; 450 total) "I Cases Predicted Cases Accrued Variance NHL (120/yr.; 450 total) Cases Predicted ~ Cases Accrued Variance AA (50/yr.; 188 total)' Cases Predicted U Cases Accrued L<L Variance ~ MDS (60/yr.; 225 total)' Cases Predicted Cases Accrued Variance G:L Benzene Poisoning (10/yr.; 38 total)' Cases Predicted "[ Cases Accrued ~ Variance ~ l"'l'") VGlllcHH. :e. aUuve preUIL:u::) [GlLe UI GH.:t.:rUGlI, 24 (-) Variance: below predicted rate of accrual. L~ "Case predictions based on historical estimates; these are not target numbers of cases required for 26 study completion. ~ LT 8/30/04 L~ BJ 4/05/05 BC 2003 1st & 2nd Otr. 3r.d Otr. 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 D 4th Otr. 35 42 7 35 66 31 12 17 5 15 26 11 3 0 -3 E 1stOtr. FG 2004 2nd Otr. 3r.d Otr. H 4th Otr. I 1stOtr. 120 180 150 437 30 257 120 180 139 155 19 -25 50 75 50 55 0 -20 60 90 97 ? 37 ? 10 15 12 ? 2? DRAFT JK 2005 2nd Otr. 3r.d Otr. 240 240 100 120 20 LM 4th Otr. 1stOtr. 300 300 125 150 25 N0 2006 2nd Otr. 3r.d Otr. 360 360 150 180 30 PQ 4th Otr. 1stOtr. 420 420 175 210 35 RS 2007 2nd Otr. 3r.d Otr. T 4th Otr. &[DATE] SH ELL-MCCLU RG-052645 uV ESTIMATED STUDY ~ TOTAL PREDICTION ~ "I 420 450 ~ U L<L ~ G:L "[ ~ ~ 24 L~ 26 ~ L~ 420 175 210 35 450 188 225 38 Benzene Health Research Consortium Case Accrual 1Q05 &[DATE] SH ELL-MCCLU RG-052646 Benzene Health Research Consortium Cash Flow Statement 1Q05 Financial Report A INCOME "I Income for Reporting Period Income, Cumulative ~ EXPENSE Actual API Expenses Expense, Cumulative 2 INCOME LESS EXPENSE ~ Reporting Period Cumulative ~ blue designates projected income or 14 expense ~ LT10/18/04 RT 04/13/05 B 2000 1st-4thQtr. C 2001 1st-4thQtr. D 2002 1st-4thQtr. E 1st&2nd Qtr. $60,246 $60,246 $2,113,132 $2,173,378 $8,367,446 $10,540,824 $448,024 $10,988,848 24,600 $24,600 1,577,811 $1,602,411 7,652,678 $9,255,088 318,759 $9,573,847 $35,646 $35,646 $535,321 $570,967 $714,768 $1,285,736 $129,265 $1,415,001 NOTE: $3,009,794 in bank at API F 2003 3rd Qtr. G 4thQtr. $3,186 $10,992,034 $4,265,241 $15,257,275 258,097 $9,831,945 310,244 $10,142,189 ($254,911) $1,160,089 $3,954,997 $5,115,086 H 1stQtr. $1,485,875 $16,743,149 66,019 $10,208,207 $1,419,856 $6,534,942 I 2nd Qtr. 2004 J 3rd Qtr. $6,746 $16,749,895 $6,506 $16,756,401 1,348,626 $11,556,834 1,047,131 $12,603,965 ($1,341,880) $5,193,061 ($1,040,625) $4,152,436 KL 4thQtr. 1stQtr. $9,292 $16,765,693 $1,096,000 $17,861,693 $2,000,899 $14,604,864 $247,035 $14,851,899 ($1,991,607) $2,160,829 $848,965 $3,009,794 M 2nd Qtr. 2005 N 3rd Qtr. $0 $17,861,693 $0 $17,861,693 $0 $14,851,899 $0 $14,851,899 $0 $3,009,794 $0 $3,009,794 0 4thQtr. $0 $17,861,693 $0 $14,851,899 $0 $3,009,794 P 1stQtr. $0 $17,861,693 $0 $14,851,899 $0 $3,009,794 Q 2nd Qtr. 2006 R 3rd Qtr. $0 $17,861,693 $0 $17,861,693 $0 $14,851,899 $0 $14,851,899 $0 $3,009,794 $0 $3,009,794 S 4thQtr. $0 $17,861,693 $0 $14,851,899 $0 $3,009,794 DRAFT 8of41 &[DATE] SH ELL-MCCLU RG-OS2647 "I ~ 2 ~ ~ 14 ~ T 1stQtr. $0 $17,861,693 $0 $14,851,899 $0 $3,009,794 U 2nd Qtr. 2007 V 3rd Qtr. $0 $17,861,693 $0 $17,861,693 $0 $14,851,899 $0 $14,851,899 $0 $3,009,794 $0 $3,009,794 W 4thQtr. $0 $17,861,693 $0 $14,851,899 $0 $3,009,794 X TOTALS $17,861,693 $14,851,899 Benzene Health Research Consortium Cash Flow Statement 1Q05 Financial Report 90f41 &[DATE] SH ELL-MCCLU RG-052648 Benzene Health Research Consortium Program Expense Summary 1Q05 Financial Report AB Cost Centers UCHSC ~ Disbursed Budgeted Actual expense CurrentVariance ~ Cumm Variance Irons - Field Expenses Disbursed Budgeted Actual expense CurrentVariance 1"1 Cumm Variance ~ Applied Health Sciences ~ Budgeted Actual expense CurrentVariance I~ Cumm Variance ~ Fudan University - Case/Control Study L. Budgeted L.. Actual expense ~ CurrentVariance ~ Cumm Variance L. Scientific & Ethics Panels/cyto wkshop L.' ~ ~ L. Budgeted Actual expense CurrentVariance Cumm Variance .)U Communications - APCO ~ ~ ,).0 ,)"1 Budgeted Actual expense CurrentVariance Cumm Variance ~ Outside Legal Counsel ~ Budgeted Actual expense CurrentVariance .)~ Cumm Variance ~ QAlQC Support "I Budgeted "I, Actual expense ~ CurrentVariance ~ Cumm Variance "I;) Contingency Funds "It Budgeted ~ Actual expense ~ CurrentVariance "I" Cumm Variance ;)U API Administrative and Overhead 2 ~ ;;).0 ;;)"1 Budgeted Actual expense CurrentVariance Cumm Variance 2000 1st-4thQtr. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 24,600 (24,600) (24,600 ~ ~ Budgeted TOTALS Actual expense CurrentVariance ;)~ Cumm Variance ~ CUMULATIVE TOTALS Budgeted Expense 0,) Variance '000 2000 0 24,600 (24,600) (24,600) 0 24,600 (24,600) 0"1 Blue: future cumulative variance has no meaning until Expense entered. ~ LT10/18/04 ~ RT 04/13/05 Amt. At UCHSC & Irons Field expo Bank acct C 2001 1st-4thQtr. D 2002 1st-4thQtr. 1,225,000 648,390 523,807 124,583 124,583 6,339,598 3,969,140 3,248,834 720,306 844,889 145,763 3,200 3,157 43 43 393,723 259,060 195,549 63,511 63,554 84,025 136,329 (52,304) (52,304) 435,513 435,406 107 (52,197) 31,303 0 31,303 31,303 42,751 15,470 27,281 58,584 30,240 18,673 11,567 11,567 120,960 5,122 115,838 127,405 60,000 0 60,000 60,000 240,000 240,738 (738) 59,262 30,000 0 30,000 30,000 120,000 13,565 106,435 136,435 13,500 0 13,500 13,500 54,000 0 54,000 67,500 00 00 00 00 65,113 52,046 13,067 11,533 260,448 209,056 51,392 39,859 '001 965,771 '00' 5,501,872 734,012 4,363,739 231,759 1,138,133 207,159 1,345,292 2001 2002 965,771 6,467,643 758,612 5,122,351 207,159 1,345,292 API disbursed Amt Expensed E 1st&2nd Qtr. 0 1,230,711 1,717,169 (486,458) 332,137 0 138,359 89,577 48,782 112,336 216,256 140,665 75,591 23,394 21,376 6,492 14,883 73,467 60,480 9,994 50,486 177,891 125,000 14,564 110,436 169,699 62,500 1,728 60,772 197,207 28,126 0 28,126 95,626 0 0 0 0 135,654 145,316 (9,662) 30,197 2,018,461 2,125,505 (107,044) 1,238,248 8,486,104 7,247,856 1,238,248 F 2003 3rd Qtr. IG 4thQtr. 0 0 0 0 332,137 (48,839) 2,039,466 553,672 1,485,794 1,813,804 0 69,179 54,382 14,797 127,133 0 55,508 169,606 (114,098) 13,035 108,128 149,389 (41,261) (17,868) 108,128 90,103 18,025 157 10,688 8,851 1,837 75,305 7,288 1,168 6,120 81,425 30,240 16,984 13,256 191,147 4,508 32,081 (27,573) 163,574 62,500 7,877 54,623 224,322 (196,636) 27,688 (224,324) (2) 31,250 0 31,250 228,457 (210,542) 17,915 (228,457) 0 14,063 0 14,063 109,689 (109,689) 0 (109,689) 0 0 290,272 0 101,473 0 188,799 0 188,799 67,826 74,997 (7,171) 23,026 '00' 393,874 312,479 81,394 1,319,642 2003 8,879,977 7,560,335 1,319,642 $12,603,965 $11,400,949 $1,203,016 75,934 88,655 (12,721) 10,305 2,064,237 1,082,361 981,876 2,301,518 10,944,214 8,642,696 2,301,518 O~ API disbursed by period (includes pre-payments for UCHSC & Irons Field 24,600 1,577,811 7,652,678 318,759 258,097 310,244 H 1stQtr. I 2004 2nd Qtr. IJ IK 3rd Qtr. 4thQtr. L 1stQtr. 0 0 0 0 1,813,804 874,031 827,532 2,045,114 (1,217,582) 586,386 874,030 0 0 0 586,386 874,030 827,532 1,535,622 (708,090) (131,540) 0 0 0 0 (131,540) 0 55,508 43,945 11,563 24,598 189,320 55,508 95,409 (39,901) (15,303) 0 55,508 49,390 6,118 (9,185) 59,680 55,508 60,427 (4,919) (14,104) 131,000 55,508 0 55,508 41,404 98,340 0 98,340 98,497 98,340 168,623 (70,283) 28,215 98,340 105,508 (7,168) 21,047 98,340 164,991 (66,651) (45,604) 110,467 70,316 40,151 (5,454) 7,288 0 7,288 88,713 7,288 27,755 (20,467) 68,246 7,288 0 7,288 75,534 7,287 64,354 (57,067) 18,467 7,287 0 7,287 25,754 (163,074) 500 (163,574) 0 3,000 12,029 (9,029) (9,029) 4,500 2,500 2,000 (7,029) 69,000 68,889 111 (6,917) 1,500 0 1,500 (5,417) 15,001 0 15,001 14,999 15,000 790 14,210 29,209 15,000 1,235 13,765 42,974 (41,704) 1,270 (42,974) 0 0 0 0 0 4,175 365 3,810 3,810 4,175 2,995 1,180 4,990 4,175 1,870 2,305 7,294 4,175 26,092 (21,918) (14,623) 4,175 4,827 (653) (15,276) 6,250 0 6,250 6,250 6,250 0 6,250 12,500 6,250 0 6,250 18,750 (18,750) 0 (18,750) 0 4,167 0 4,167 4,167 0 0 0 188,799 0 0 0 188,799 0 0 0 188,799 300,000 3,000 297,000 485,799 0 3,496 (3,496) 482,303 66,700 65,154 1,546 11,851 66,700 73,084 (6,384) 5,467 '000 90,188 1,083,793 109,964 2,425,798 (19,776) (1,342,006) 2,281,742 939,736 2004 11,034,402 12,118,195 8,752,660 11,178,458 2,281,742 939,736 $1,175,224 unspent at UCHSC as of 6130104 (no expense reporting for 3004) $27,044 In Irons' field exp bank acct as of 6130104 (3004 exp report outstandinq) $1,202,268 Total as of 6130104 72,700 61,988 10,712 16,179 263,761 222,491 41,270 981,006 12,381,955 11,400,949 981,006 64,400 76,254 (11,854) 4,325 1,065,788 2,000,899 (935,111) 45,895 13,447,743 13,401,848 45,895 29,280 37,396 (8,116) 3,791 212,383 247,035 (34,653) 11,242 13,660,126 13,648,884 11,242 66,019 1,348,626 1,047,131 DRAFT 1,338,560 378,035 M 2 2nd Qtr. 874,030 827,532 0 827,532 686,156 0 55,508 0 55,508 96,912 110,467 0 110,467 105,013 7,287 0 7,287 33,041 1,000 0 1,000 (4,417) 0 0 0 0 4,175 0 4,175 (11,101) 4,167 0 4,167 8,333 0 0 0 482,303 26,680 0 26,680 22,889 1,036,815 0 1,036,815 1,048,057 2 14,696,941 13,648,884 1,048,057 874,030 Page 10 of41 &[DATE] SH ELL-MCCLU RG-052649 NI0 05 3rd Qtr. 4thQtr. ~0 0 0 0 ~ 686,156 131,000 55,508 0 55,508 1"1 152,420 ~ ~ 110,467 0 110,467 I~ 215,480 ~ L. 7,287 L.. ~ ~ L. 0 7,287 40,328 L.' ~ ~ L. 4,500 0 4,500 83 .)U ~ ~ ,).0 ,)"1 0 0 0 0 ~ ~ 4,175 0 4,175 .)~ (6,927) ~ "I "I, ~ ~ "I;) 4,167 0 4,167 12,500 "It ~ ~ "I" :>u 0 0 0 482,303 2 ~ ;;).0 ;;)"1 ~ u, ~ 40,650 0 40650 63539 226,753 0 226,753 :>~ 1,274,810 ~05 14,923,694 13,648,884 0,) 1,274,810 0"1 ~ ~ 874,030 827,532 0 827,532 1,503,852 0 55,508 0 55,508 207,928 110,467 0 110,467 325,947 7,287 0 7,287 47,615 69,000 0 69,000 69,083 1,946 0 1,946 1,946 4,175 0 4,175 (2,752) 4,167 0 4,167 16,667 0 0 0 482,303 26,650 0 26,650 90,189 1,106,731 0 1,106,731 2,381,541 16,030,425 13,648,884 2,381,541 p IQI RIs 2006 1stQtr. 2nd Qtr. 3rd Qtr. 4thQtr. 0 0 0 0 1,503,852 874,030 827,539 0 827,539 2,321,548 0 0 0 0 2,321,548 874,030 827,542 0 827,542 3,139,244 131,000 55,508 0 55,508 263,436 0 55,508 0 55,508 318,944 131,000 55,507 0 55,507 374,451 0 55,507 0 55,507 429,958 112,496 0 112,496 438,443 112,496 0 112,496 550,939 112,496 0 112,496 663,435 112,496 0 112,496 775,932 7,287 0 7,287 54,902 7,287 0 7,287 62,189 7,287 0 7,287 69,476 7,287 0 7,287 76,763 1,000 0 1,000 70,083 1,000 0 1,000 71,083 4,000 0 4,000 75,083 65,000 0 65,000 140,083 0 0 0 1,946 0 0 0 1,946 0 0 0 1,946 1,946 0 1,946 3,893 4,175 0 4,175 1,422 4,175 0 4,175 5,597 4,175 0 4,175 9,771 4,175 0 4,175 13,946 4,167 0 4,167 20,833 4,167 0 4,167 25,000 4,167 0 4,167 29,167 4,167 0 4,167 33,333 0 0 0 482,303 0 0 0 482,303 0 0 0 482,303 0 0 0 482,303 29,250 0 29,250 119,439 213,882 0 213,882 2,595,424 16,244,307 13,648,884 2,595,424 26,650 40,650 00 26,650 40650 146,089 u. 186739 1,038,821 228,281 00 1,038,821 228,281 3,634,245 3,862,527 2006 17,283,129 17,511,410 13,648,884 13,648,884 3,634,245 3,862,527 26,650 0 26,650 213,389 1,104,770 0 1,104,770 4,967,296 18,616,180 13,648,884 4,967,296 Benzene Health Research Consortium Program Expense Summary 1Q05 Financial Report T I uI V Iw 2007 1stQtr. 2nd Qtr. 3rd Qtr. 4thQtr. 0 0 0 0 3,139,244 874,030 827,542 0 827,542 3,956,940 0 0 0 0 3,956,940 0 827,542 0 827,542 4,774,636 104,714 55,507.0 0 55,507 485,465 0 55,507 0 55,507 540,972 0 55,507 0 55,507 596,479 0 55,507 0 55,507 651,986 45,833 0 45,833 821,765 0 0 0 821,765 0 0 0 821,765 0 0 0 821,765 7,287 0 7,287 84,050 7,287 0 7,287 91,337 7,287 0 7,287 98,624 7,287 0 7,287 105,911 1,000 0 1,000 141,083 1,000 0 1,000 142,083 4,000 0 4,000 146,083 38,000 0 38,000 184,083 0 0 0 3,893 0 0 0 3,893 0 0 0 3,893 1,946 0 1,946 5,839 4,175 0 4,175 18,120 4,175 0 4,175 22,295 4,175 0 4,175 26,469 4,175 0 4,175 30,644 4,167 0 4,167 37,500 4,167 0 4,167 41,667 4,167 0 4,167 45,833 4,167 0 4,167 50,000 0 0 0 482,303 0 0 0 482,303 0 0 0 482,303 0 0 0 482,303 29,250 0 29,250 242,639 26,650 0 26,650 269,289 40,650 0 40650 309939 26,650 0 26,650 336,589 X TOTALS 14,508,000 14,508,000 9,624,218 827,542 4,883,782 1,417,200 1,413,428 761,442 429,958 651,986 2,283,095 1,461,330 0 821,765 230,000 124,090 7,287 105,911 350,854 166,772 38,000 184,083 300,000 294,161 3,893 5,839 100,000 69,356 30,644 30,644 50,000 0 50,000 50,000 590,272 107,969 0 482,303 1,245,135 883,946 361,189 361,189 147,218 0 147,218 5,114,514 18,763,398 13,648,884 5,114,514 926,327 115,785 00 926,327 115,785 6,040,842 6,156,627 2007 19,689,725 19,805,511 13,648,884 13,648,884 6,040,842 6,156,627 965,274 0 965,274 7,121,900 20,770,784 13,648,884 7,121,900 20,770,784 13,493,284 7,121,900 7,277,500 21,070,784 13,648,884 7,421,900 O~ 131,000 874,030 131,000 874,030 131,000 874,030 104,714 874,030 0 0 19,032,824 Page 11 of41 &[DATE] SH ELL-MCCLU RG-052650 Benzene Health Research Consortium UCHSC Grant 1Q05 Financial Report A Grant Payments .q Disbursed ~ Personnel ~ Budgeted Actual expense CurrentVariance ~ Cumm Variance ~ Operating Expenses Budgeted Actual expense ~ CurrentVariance ~ Cumm Variance Subcontracts Budgeted Actual expense ~ CurrentVariance Cumm Variance L' Travel -. Budgeted Actual expense L CurrentVariance L"I Cumm Variance ~ Equipment ~ Budgeted L. Actual expense L" CurrentVariance ::::~ Cumm Variance ~ Indirect Budgeted Actual expense CurrentVariance Cumm Variance UCHSC (x81 05) Cost Centers Budgeted ~ Actual expense ~ CurrentVariance ..)::;1 Cumm Variance qU CUMULATIVE TOTALS ~ Budgeted ~ Expense "f..) Variance TOTALS ~ Blue: future cumulative variance has no meaning until Expense entered. ~ LT3/11/05 ~ BJ4/05/05 "I" B 2001 1st-4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. 1,225,000 6,339,598 172,140 172,140 573,160 714,688 -141,528 -141,528 331,316 314,703 16,613 -124,915 13,131 12,177 954 954 378,462 301,522 76,940 77,894 198,373 158,850 39,523 117,417 123,629 123,629 123,629 1,795,030 1,025,372 769,658 893,287 549,014 845,860 -296,846 596,441 23,947 8,647 15,300 15,300 11,340 346 10,994 26,294 $291,568 $291,568 $0 $0 $918,645 $899,642 $19,003 $19,003 $0 $274,508 ($274,508) ($255,505) 2001 2001 $47,922 $47,922 ($0) ($0) $648,390 $523,807 $124,583 $124,583 $648,390 $523,807 $124,583 $279,896 $298,963 ($19,067) ($19,067) 2002 $3,969,140 $3,248,834 $720,306 $844,889 2002 $4,617,530 $3,772,641 $844,889 $140,668 $122,902 $17,766 ($1,301) $1,230,711 $1,717,169 ($486,458) $332,137 $5,848,241 $5,489,810 $358,431 Note: Actual expenses from Progress Report or UC Grants & Contracts Financials. Amt. paid UCHSC to date: Amt. expensed to date: Amt. In UCHSC bank acct: $9,263,820 $8,088,596 $1,175,224 Page 12 of41 &[DATE] SHELL-MCCLURG-052651 Benzene Health Research Consortium UCHSC Grant 1Q05 Financial Report "I 2 ~ ~ ~ ~ ~ E 2003 3rd Qtr. ~ L' -. L L"I ~ ~ L L, ~~ ~ .."~ ,,;;) 2003 ~ ~,," "IU 2003 ~ .~" ~ "I;;) "It ~ (Adjusted 4003: $48,839 attributed to UCHSC in 3003 Report has been reallocated to Contingency: $25,000 pre-consortium grant in 2001; $3,600 for IRB Review in 2002; $20,239 for EMBSI "feasibility study" in 2002) ~ (Adjusted 4003: 2001 costs had been double expensed in 2002 column; (-$523,807) adjusment made in 4003) "I" 0 0 0 0 -124,915 0 0 0 117,417 0 0 0 596,441 0 0 0 26,294 $0 $0 $0 ($255,505) $0 $0 $0 ($1,301) $0 $0 $0 $332,137 $5,848,241 $5,489,810 $358,431 F 4thQtr. -48,839 293,007 58,188 234,819 109,904 259,003 150,657 108,346 225,763 988,733 565,870 422,863 1,019,304 4,127 0 4,127 30,421 $350,000 ($274,568) $624,568 $369,063 $144,596 $53,525 $91,071 $89,770 $2,039,466 $553,672 $1,485,794 $1,813,804 $7,887,707 $6,043,482 $1,844,225 G 1stQtr. H 2004 2nd Qtr. 0 874,031 0 0 0 109,904 195,778 211,016 -15,238 94,666 0 0 0 225,763 195,773 364,542 -168,769 56,994 0 0 0 1,019,304 286,990 1,128,507 -841,517 177,787 0 0 0 30,421 9,836 0 9,836 40,257 $0 $0 $0 $369,063 $48,050 $192,340 ($144,290) $224,773 $0 $0 $0 $89,770 $0 $0 $0 $1,813,804 $7,887,707 $6,043,482 $1,844,225 2004 2004 $91,105 $148,709 ($57,604) $32,166 $827,532 $2,045,114 ($1,217,582) $586,386 $8,715,239 $8,088,596 $626,643 UCHSC statement error for travel, off by +$1 05 (4003) I 3rd Qtr. 874,030 0 0 0 94,666 0 0 0 56,994 0 0 0 177,787 0 0 0 40,257 $0 $0 $0 $224,773 $0 $0 $0 $32,166 $0 $0 $0 $586,386 $8,715,239 $8,088,596 $626,643 Page 13 of41 &[DATE] SH ELL-MCCLU RG-OS26S2 Benzene Health Research Consortium UCHSC Grant 1Q05 Financial Report "I 2 ~ ~ ~ ~ ~ ~ L' -. L L"I ~ ~ L L, ~~ ~ ..~",,;;) ~ ~,," "IU ~ .~" ~ "I;;) "It ~ ~ "I" J 4thQtr. 874,030 195,778 229,260 -33,482 61,184 195,773 237,258 -41,485 15,509 286,990 948,696 -661,706 -483,919 9,836 0 9,836 50,093 $48,050 $0 $48,050 $272,823 $91,105 $120,408 ($29,303) $2,863 $827,532 $1,535,622 ($708,090) ($131,540) $9,542,771 $9,624,218 ($81,447) K 1stQtr. 0 0 0 0 61,184 0 0 0 15,509 0 0 0 -483,919 0 0 0 50,093 $0 $0 $0 $272,823 $0 $0 $0 $2,863 $0 $0 $0 ($131,540) $9,542,771 $9,624,218 ($81,447) L 2nd Qtr. 2005 M 3rd Qtr. N 4thQtr. 0 1stQtr. 874,030 0 874,030 0 195,778 0 195,778 256,962 0 0 0 256,962 195,778 0 195,778 452,740 0 0 0 452,740 195,773 0 195,773 211,282 0 0 0 211,282 195,773 0 195,773 407,055 0 0 0 407,055 286,990 0 286,990 -196,929 0 0 0 -196,929 286,990 0 286,990 90,061 0 0 0 90,061 9,836 0 9,836 59,929 0 0 0 59,929 9,836 0 9,836 69,765 0 0 0 69,765 $48,050 $0 $48,050 $320,873 $0 $0 $0 $320,873 $48,050 $0 $48,050 $368,923 $0 $0 $0 $368,923 $91,105 $0 $91,105 $93,968 $0 $0 $0 $93,968 2005 $827,532 $0 $0 $0 $827,532 $0 $686,156 $686,156 2005 $10,370,303 $10,370,303 $9,624,218 $9,624,218 $746,085 $746,085 $91,105 $0 $91,105 $185,073 $827,532 $0 $827,532 $1,503,852 $11,197,835 $9,624,218 $1,573,617 $0 $0 $0 $185,073 $0 $0 $0 $1,503,852 $11,197,835 $9,624,218 $1,573,617 P 2nd Qtr. 2006 Q 3rd Qtr. R 4thQtr. S 1stQtr. 874,030 0 874,030 0 195,778 0 195,778 648,518 0 0 0 648,518 195,778 0 195,778 844,296 0 0 0 844,296 195,773 0 195,773 602,828 0 0 0 602,828 195,773 0 195,773 798,601 0 0 0 798,601 286,990 0 286,990 377,051 0 0 0 377,051 286,990 0 286,990 664,041 0 0 0 664,041 9,843 0 9,843 79,608 0 0 0 79,608 9,846 0 9,846 89,454 0 0 0 89,454 $48,050 $0 $48,050 $416,973 $0 $0 $0 $416,973 $48,050 $0 $48,050 $465,023 $0 $0 $0 $465,023 $91,105 $0 $91,105 $276,178 $0 $0 $0 $276,178 2006 $827,539 $0 $0 $0 $827,539 $0 $2,321,548 $2,321,548 2006 $12,025,374 $12,025,374 $9,624,218 $9,624,218 $2,401,156 $2,401,156 $91,105 $0 $91,105 $367,283 $827,542 $0 $827,542 $3,139,244 $12,852,916 $9,624,218 $3,228,698 $0 $0 $0 $367,283 $0 $0 $0 $3,139,244 $12,852,916 $9,624,218 $3,228,698 T 2nd Qtr. 2007 U 3rd Qtr. 874,030 0 195,778 0 195,778 1,040,074 0 0 0 1,040,074 195,773 0 195,773 994,374 0 0 0 994,374 286,990 0 286,990 951,031 0 0 0 951,031 9,846 0 9,846 99,300 0 0 0 99,300 $48,050 $0 $48,050 $513,073 $0 $0 $0 $513,073 $91,105 $0 $91,105 $458,388 $0 $0 $0 $458,388 2007 $827,542 $0 $0 $0 $827,542 $0 $3,956,940 $3,956,940 2007 $13,680,458 $13,680,458 $9,624,218 $9,624,218 $4,056,240 $4,056,240 V 4thQtr. 195,778 0 195,778 1,235,852 195,773 0 195,773 1,190,147 286,990 0 286,990 1,238,021 9,846 0 9,846 109,146 $48,050 $0 $48,050 $561,123 $91,105 $0 $91,105 $549,493 $827,542 $0 $827,542 $4,774,636 $14,508,000 $9,624,218 $4,883,782 DRAFT W TOTALS 14,508,000 2,935,847 1,699,995 195,778 1,235,852 2,415,153 1,225,006 195,773 1,190,147 5,752,326 4,514,305 286,990 1,238,021 118,139 8,993 9,846 109,146 $1,944,613 $1,383,490 $48,050 $561,123 $1,341,922 $792,429 $91,105 $549,493 $14,508,000 $9,624,218 $827,542 $4,883,782 $14,508,000 $9,624,218 $4,883,782 Page 14 of41 &[DATE] SH ELL-MCCLU RG-052653 A UCHSC Subcontracts Fudan University " Actual expense IPHSC Actual expense SMCDCP Actual expense -"'- EMBSI Actual expense Children's Hospital Cincinnati !. Actual expense TOTALS 1'1 Actual expense ~ LT 8/6/04 1::1 BJ 4/05/05 Benzene Health Research Consortium UCHSC Subcontract 1Q05 Financial Report B 2001 1st-4thQtr. 2001 "Total subcontractor expenses" from study report (preliminary figure); "actual expenses" from UC Office of Grants & Contracts spreadsheet (final figures). C 2002 1st-4thQtr. D 1st&2nd Qtr. EI 2003 F 3rd & 4th Qtr. GI H III J 2004 1st&2nd Qtr. 3rd & 4th Qtr. KI L 1M 2005 1st&2nd Qtr. 0 0 411,935 468,341 1,088,352 880,342 0 0 0 8,339 27,496 7,683 0 0 0 0 45,563 24,766 2,500 0 0 0 0 372,725 00 00 00 2002 $0 $1,025,372 7,298 2003 $845,860 45,267 $565,870 29,972 2004 $1,128,507 $1,128,507 68,354 $948,696 0 2005 $0 DRAFT - Page 15 of 41 &[DATE] SH ELL-MCCLU RG-OS26S4 N 3rd & 4th Qtr. 01 P IQI R 2006 1st&2nd Qtr. 3rd & 4th Qtr. sl T IU 2007 1st&2nd Qtr. v 3rd & 4th Qtr. 40 0 0 0 0 00 00 0 00 00 0 -"'- 00 00 0 !. 0 14 $0 0 2006 $0 0 $0 0 2007 $0 0 $0 ~ W TOTALS 2,848,970 43,518 72,829 372,725 150,891 $3,488,933 1::1 Benzene Health Research Consortium UCHSC Subcontract 1Q05 Financial Report Page 16 of 41 &[DATE] SH ELL-MCCLU RG-052655 Benzene Health Research Consortium Irons Field Expenses 1Q05 Financial Report A IRONS T&E (X81 06) Cost Centers Payments .q Disbursed ~ Airfare & related expenses ~ Budgeted Actual expense CurrentVariance ~ Cumm Variance ~ Apartment I hotel & related expenses Budgeted Actual expense ~ CurrentVariance ~ Cumm Variance Other expenses e.g. taxi, limo, misc. Budgeted Actual expense ~ CurrentVariance I ::1 Cumm Variance L' ~ Budgeted Actual expense L.. CurrentVariance L."+ Cumm Variance ~ CUMULATIVE TOTALS ~ Budgeted L. Expense L., Variance riO- Blue: future cumulative variance has no meaning until Expense entered. ,,"+ LT 2/14/05 ~ BJ4/05/05 B 2001 4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. E 3rd Qtr. $145,763 $1,280 $1,606 ($326) ($326) $1,280 $1,024 $256 $256 $640 $528 $112 $112 $393,723 $103,624 $75,179 $28,445 $28,119 $103,624 $89,717 $13,907 $14,163 $51,812 $30,653 $21,159 R,272 $0 $55,343 $27,359 $27,984 $56,103 $55,343 $45,291 $10,052 $24,216 $27,672 $16,926 $10,746 $32017 $0 $27,672 $25,079 $2,593 $58,696 $27,672 $21,200 $6,472 $30,687 $13,836 $8,103 $47,240 $79,257 2001 $3,200 $3,157 $43 $43 $3,200 $3,157 $43 $259,060 $195,549 $63,511 $63,554 2002 $262,260 $198,706 $63,554 $138,359 $89,577 $48,782 $112,336 $400,619 $288,283 $112,336 $69,179 $54,382 $14,797 $127,133 $469,798 $342,665 $127,133 "Actual expense" is from quarterly expense reports, and does not reflect contract prepayments Amt paid to Irons to date: Amt Irons has spent: Amt. In Irons bank acct: $788,486 numbers as of 12131/04 $761,442 $27,044 Page 17 of41 &[DATE] SH ELL-MCCLU RG-052656 "I 2 ~ ~ ~ ~ ~ 2003 F 4thQtr. ~,::I L' -. L L"I ~ ~ L L, 2003 L 4Q03 ADJUSTMENT - 200112002 expense underrecorded; +$114,289 adjustment .)U ~ ~ .).) ,)"1 ~ ~ ~ ~ "I Benzene Health Research Consortium Irons Field Expenses 1Q05 Financial Report G 1stQtr. HI 2004 2nd Qtr. 3rd Qtr. J 4thQtr. $0 $0 $189,320 $0 $59,680 $22,200 $74,850 ($52,650) $6,046 $22,205 $81,131 ($58,926) ($28,239) $11,103 $13,625 ($2,522) $76735 $22,200 $18,124 $4,076 $10,122 $22,205 $20,041 $2,164 ($26,075) $11,103 $5,780 $5,323 $82058 $22,200 $32,651 ($10,451) ($329) $22,205 $55,100 ($32,895) ($58,970) $11,103 $7,658 $3,445 $85,503 $22,200 $14,144 $8,056 $7,728 $22,205 $26,225 ($4,020) ($62,990) $11,103 $9,021 $2,082 $87585 $22,200 $29,290 ($7,090) $637 $22,205 $15,200 $7,005 ($55,985) $11,103 $15,937 ($4,834) $82,751 $55,508 $169,606 ($114,098) $13,035 $55,508 $43,945 $11,563 $24,598 $525,306 $512,270 $13,035 $580,814 $556,215 $24,598 $55,508 $55,508 $95,409 $49,390 ($39,901) $6,118 ($15,303) ($9,185) 2004 $636,322 $691,830 $651,624 $701,014 ($15,303) ($9,185) $55,508 $60,427 ($4,919) ($14,104) $747,338 $761,442 ($14,104) K 1stQtr. LM 2005 2nd Qtr. 3rd Qtr. $131,000 $0 $131,000 $22,200 $0 $22,200 $22,837 $22,205 $0 $22,205 ($33,780) $11,103 $0 $11,103 $93,854 $22,200 $0 $22,200 $45,037 $22,205 $0 $22,205 ($11,575) $11,103 $0 $11,103 $104957 $22,200 $0 $22,200 $67,237 $22,205 $0 $22,205 $10,630 $11,103 $0 $11,103 $116,060 $55,508 $0 $55,508 $41,404 $802,846 $761,442 $41,404 $55,508 $55,508 $0 $0 $55,508 $55,508 $96,912 $152,420 2005 $858,354 $913,862 $761,442 $761,442 $96,912 $152,420 N 4thQtr. $0 $22,200 $0 $22,200 $89,437 $22,205 $0 $22,205 $32,835 $11,103 $0 $11,103 $127,163 $55,508 $0 $55,508 $207,928 $969,370 $761,442 $207,928 0 1stQtr. $131,000 $22,200 $0 $22,200 $111,637 $22,205 $0 $22,205 $55,040 $11,103 $0 $11,103 $138,266 $55,508 $0 $55,508 $263,436 $1,024,878 $761,442 $263,436 P 2006 2nd Qtr. Q 3rd Qtr. R 4thQtr. $0 $131,000 $0 $22,200 $0 $22,200 $133,837 $22,205 $0 $22,205 $77,245 $11,103 $0 $11,103 $149369 $22,200 $0 $22,200 $156,037 $22,205 $0 $22,205 $99,450 $11,102 $0 $11,102 $160471 $22,200 $0 $22,200 $178,237 $22,205 $0 $22,205 $121,655 $11,102 $0 $11,102 $171,573 $55,508 $55,507 $0 $0 $55,508 $55,507 $318,944 $374,451 2006 $1,080,386 $1,135,893 $761,442 $761,442 $318,944 $374,451 $55,507 $0 $55,507 $429,958 $1,191,400 $761,442 $429,958 S 1stQtr. TU 2007 2nd Qtr. 3rd Qtr. V 4thQtr. $104,714 $0 $0 $0 $22,200 $0 $22,200 $200,437 $22,205 $0 $22,205 $143,860 $11,102 $0 $11,102 $182,675 $22,200 $0 $22,200 $222,637 $22,205 $0 $22,205 $166,065 $11,102 $0 $11,102 $193, $22,200 $0 $22,200 $244,837 $22,205 $0 $22,205 $188,270 $11,102 $0 $11,102 $204,879 $22,200 $0 $22,200 $267,037 $22,205 $0 $22,205 $210,475 $11,102 $0 $11,102 $215,981 $55,507 $0 $55,507 $485,465 $1,246,907 $761,442 $485,465 $55,507 $55,507 $0 $0 $55,507 $55,507 $540,972 $596,479 2007 $1,302,414 $1,357,921 $761,442 $761,442 $540,972 $596,479 $55,507 $0 $55,507 $651,986 $1,413,428 $761,442 $651,986 DRAFT 7 Page 18 of41 &[DATE] SH ELL-MCCLU RG-OS26S7 W TOTALS "I 2 ~ ~ ~ ~ ~ ~,::I L' -. L L"I ~ ~ L L' L .)U ~ ~ .).) ,)"1 ~ ~ $1,417,200 $565,319 $298,282 $178,237 $267,037 $565,404 $354,929 $121,655 $210,475 $282,705 $108,231 $171,573 $174,474 $1,413,428 $761,442 $429,958 $651,986 $1,413,428 $761,442 $651,986 ~ ~ "I Benzene Health Research Consortium Irons Field Expenses 1Q05 Financial Report Page 19 of41 &[DATE] SH ELL-MCCLU RG-052658 Benzene Health Research Consortium AHS 1Q05 Financial Report A "I .2 ~ ~ ~ ~ ~ ~ L' -. L L"I ~ '<0 Labor Budgeted Actual expense Current Variance Cumm Variance Travel & expenses Budgeted Actual expense Current Variance Cumm Variance Other direct expenses Budgeted Actual expense Current Variance Cumm Variance Budgeted Actual expense Current Variance Cumm Variance Budgeted Expense Variance AHS (X81 07) Cost Centers TOTALS CUMULATIVE TOTALS ~ ~ L .)U Blue: future cumulative variance has no meaning until Expense entered. LT10/18/04 BJ 4/05/05 B 2001 4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. E 3rd Qtr. 2003 F 4thQtr. G 1stQtr. HI 2004 2nd Qtr. 3rd Qtr. J 4thQtr. K 1stQtr. $84,025 $134,134 ($50,109) ($50,109) $290,013 $394,505 ($104,492) ($154,601) $157,756 $124,124 $33,632 ($120,970) $78,878 $137,280 ($58,402) ($179,372) $78,878 $73,690 $5,188 ($174,184) $72,090 $0 $72,090 ($102,094) $72,090 $149,980 ($77,890) ($179,984) $72,090 $92,201 ($20,111) ($200,094) $72,090 $162,216 ($90,126) ($290,220) $84,217 $70,316 $13,901 ($276,319) $0 $2,118 ($2,118) ($2,118) $140,000 $39,458 $100,542 $98,424 $57,000 $16,541 $40,459 $138,883 $28,500 $12,109 $16,391 $155,274 $28,500 $16,413 $12,087 $167,361 $25,500 $0 $25,500 $192,861 $25,500 $18,534 $6,966 $199,827 $25,500 $12,522 $12,978 $212,805 $25,500 $2,564 $22,936 $235,741 $25,500 $0 $25,500 $261,241 $0 $77 ($77) $77 2001 $84,025 $136,329 ($52,304) ($52,304) 2001 $84,025 $136,329 ($52,304) $5,500 $1,443 $4,057 $3980 200; $435,513 $435,406 $107 ($52,197) 2002 $519,538 $571,735 ($52,197) $1,500 $0 $1,500 $5480 $216,256 $140,665 $75,591 $23,394 $735,794 $712,400 $23,394 $750 $0 $750 $6230 $108,128 $149,389 ($41,261) ($17,868) $843,921 $861,789 ($17,868) 2003 2003 4Q03 Adjustment: expense reduced by $52,634; transferred to contingency since these were pre-consortia expenses $750 $0 $750 $6980 $108,128 $90,103 $18,025 $157 $952,049 $951,892 $157 $750 $0 $750 $7730 $98,340 $0 $98,340 $98,497 $1,050,389 $951,892 $98,497 $750 $750 $109 $785 $641 $8371 ($35) $8,336 'd' $98,340 $98,340 $168,623 $105,508 ($70,283) ($7,168) $28,215 2004 $21,047 $1,148,730 $1,120,515 $28,215 $1,247,070 $1,226,023 $21,047 $750 $211 $539 $8,875 $98,340 $164,991 ($66,651) ($45,604) $1,345,410 $1,391,014 ($45,604) $750 $0 $750 $9,625 $110,467 $70,316 $40,151 ($5,454) $1,455,877 $1,461,330 ($5,454) DRAFT Page 20 of41 &[DATE] SH ELL-MCCLU RG-052659 Benzene Health Research Consortium AHS 1Q05 Financial Report "I .2 ~ ~ ~ ~ ~ ~ L' -. L L"I ~ '<0 ~ ~ L .)U LM 2005 2nd Qtr. 3rd Qtr. N 4thQtr. 0 1stQtr. $84,217 $0 $84,217 ($192,103) $84,217 $0 $84,217 ($107,886) $84,217 $0 $84,217 ($23,669) $76,746 $0 $76,746 $53,077 $25,500 $0 $25,500 $286,741 $25,500 $0 $25,500 $312,241 $25,500 $0 $25,500 $337,741 $35,000 $0 $35,000 $372,741 $750 $0 $750 $10,375 $750 $0 $750 $1 125 05 $110,467 $110,467 $0 $0 $110,467 $110,467 $105,013 $215,480 2005 $1,566,344 $1,676,810 $1,461,330 $1,461,330 $105,013 $215,480 $750 $0 $750 $11,875 $110,467 $0 $110,467 $325,947 $1,787,277 $1,461,330 $325,947 $750 $0 $750 $1 625 $112,496 $0 $112,496 $438,443 $1,899,773 $1,461,330 $438,443 PQ 2006 2nd Qtr. 3rd Qtr. $76,746 $0 $76,746 $129,823 $76,746 $0 $76,746 $206,570 $35,000 $0 $35,000 $407,741 $35,000 $0 $35,000 $442,741 $750 $0 $750 $13375 $750 $0 $750 $14,125 10. $112,496 $112,496 $0 $0 $112,496 $112,496 $550,939 $663,435 2006 $2,012,270 $2,124,766 $1,461,330 $1,461,330 $550,939 $663,435 R 4thQtr. $76,746 $0 $76,746 $283,316 $35,000 $0 $35,000 $477,741 $750 $0 $750 $14,875 $112,496 $0 $112,496 $775,932 $2,237,262 $1,461,330 $775,932 S 1stQtr. $10,033 $0 $10,033 $293,349 $32,000 $0 $32,000 $509,741 $3,800 $0 $3800 $18,675 $45,833 $0 $45,833 $821,765 $2,283,095 $1,461,330 $821,765 T 2nd Qtr. 2007 U 3rd Qtr. $0 $0 $0 $293,349 $0 $0 $0 $509,741 $0 $0 $0 $18,675 $0 $0 $0 $293,349 $0 $0 $0 $509,741 $0 $0 $0 $18,675 $0 $0 $0 $0 $0 $0 $821,765 $821,765 2007 $2,283,095 $2,283,095 $1,461,330 $1,461,330 $821,765 $821,765 V 4thQtr. $0 $0 $0 $293,349 $0 $0 $0 $509,741 $0 $0 $0 $18,675 $0 $0 $0 $821,765 $2,283,095 $1,461,330 $821,765 W TOTALS $1,631,795 $1,338,446 $0 $293,349 $630,000 $120,259 $0 $509,741 $21,300 $2,625 $0 $18,675 $2,283,095 $1,461,330 $0 $821,765 $2,283,095 $1,461,330 $821,765 Page 21 of41 &[DATE] SH ELL-MCCLU RG-OS2660 Benzene Health Research Consortium Fudan 1Q05 Financial Report A FUDAN (X81 08) Cost Centers Labor (salary + benefits) "I Budgeted 2 Actual expense ~ Current Variance Cumm Variance Expenses J:L ~ Budgeted Actual expense Current Variance IL Cumm Variance ~ Overhead (15%) ~ Budgeted Actual expense Current Variance Cumm Variance ~ LI Budgeted Actual expense TOTALS -. Current Variance Cumm Variance CUMULATIVE TOTALS L"I ~ '<0 Budgeted Expense Variance ~ Blue: future cumulative variance has no meaning until Expense entered. ~ LT 10120104 "L BJ 4105/05 B 2001 $9,620 $0 $9,620 $9,620 $17,600 $0 $17,600 $17,600 $4,083 $0 $4083 $4083 2001 $31,303 $0 $31,303 $31,303 2001 $31,303 $0 $31,303 C 2002 D 1Q12Q03 E 2003 3003 F 4Q03 $8,775 $8,774 $1 $9,621 $4,388 $6,492 ($2,105) $7,516 $2,194 $0 $2,194 $9,709 $1,548 $0 $1,548 $11,257 $28,400 $4,870 $23,530 $41,130 $14,200 $0 $14,200 $55,330 $7,100 $8,851 ($1,751) $53,579 $4,645 $1,168 $3,477 $57,056 $5,576 $1,825 $3,751 $7834 200; $42,751 $15,470 $27,281 $58,584 2002 $74,054 $15,470 $58,584 $2,788 $0 $2,788 $10622 $21,376 $6,492 $14,883 $73,467 $95,430 $21,962 $73,467 $1,394 $0 $1,394 $12016 2003 $10,688 $8,851 $1,837 $75,305 2003 $106,117 $30,813 $75,305 $1,095 $0 $1,095 $13111 $7,288 $1,168 $6,120 $81,425 $113,405 $31,981 $81,425 G 1Q04 $1,548 $0 $1,548 $12,805 $4,645 $0 $4,645 $61,701 $1,095 $0 $1,095 $14,206 $7,288 $0 $7,288 $88,713 $120,693 $31,981 $88,713 HI 2004 2Q04 3Q04 $1,548 $14,385 ($12,837) ($32) $1,548 $0 $1,548 $1,516 $4,645 $9,750 ($5,105) $56,596 $4,645 $0 $4,645 $61,241 $1,095 $3,620 ($2525) $11681 $1,095 $0 $1,095 $12776 DO $7,288 $7,288 $27,755 $0 ($20,467) $7,288 $68,246 $75,534 2004 $127,981 $135,269 $59,736 $59,736 $68,246 $75,534 JK 4Q04 $1,548 $46,409 ($44,861) ($43,345) $4,645 $10,983 ($6,338) $54,903 $1,094 $6,961 ($5,867) $6,909 1Q05 $1,548 $0 $1,548 ($41,797) $4,645 $0 $4,645 $59,548 $1,094 $0 $1,094 $8003 $7,287 $64,354 ($57,067) $18,467 $142,556 $124,090 $18,467 $7,287 $0 $7,287 $25,754 $149,843 $124,090 $25,754 DRAFT LM 2005 2Q05 3005 $1,548 $0 $1,548 ($40,249) $1,548 $0 $1,548 ($38,701) $4,645 $0 $4,645 $64,193 $4,645 $0 $4,645 $68,838 $1,094 $0 $1,094 $9,097 $1,094 $0 $1,094 $10191 '05 $7,287 $7,287 $0 $0 $7,287 $7,287 $33,041 $40,328 2005 $157,130 $164,417 $124,090 $124,090 $33,041 $40,328 N0 4Q05 $1,548 $0 $1,548 ($37,153) $4,645 $0 $4,645 $73,483 $1,094 $0 $1,094 $11,285 1Q06 $1,548 $0 $1,548 ($35,605) $4,645 $0 $4,645 $78,128 $1,094 $0 $1,094 $12,379 $7,287 $0 $7,287 $47,615 $7,287 $0 $7,287 $54,902 $171,704 $124,090 $47,615 $178,991 $124,090 $54,902 Note: budget is in 2001 $. P 2006 2Q06 $1,548 $0 $1,548 ($34,057) $4,645 $0 $4,645 $82,773 $1,094 $0 $1,094 $13473 200. $7,287 $0 $7,287 $62,189 2006 $186,278 $124,090 $62,189 Q 3006 $1,548 $0 $1,548 ($32,509) $4,645 $0 $4,645 $87,418 $1,094 $0 $1,094 $14567 $7,287 $0 $7,287 $69,476 $193,565 $124,090 $69,476 R 4Q06 $1,548 $0 $1,548 ($30,961) $4,645 $0 $4,645 $92,063 $1,094 $0 $1,094 $15,661 $7,287 $0 $7,287 $76,763 $200,852 $124,090 $76,763 S 1Q07 $1,548 $0 $1,548 ($29,413) $4,645 $0 $4,645 $96,708 $1,094 $0 $1,094 $16755 $7,287 $0 $7,287 $84,050 $208,139 $124,090 $84,050 Page 22 of41 &[DATE] SHELL-MCCLURG-052661 "I 2 ~ J:L ~ IL ~ ~ ~ LI -. L"I ~ '<0 ~ ~ "L TU 2007 2Q07 3007 $1,548 $0 $1,548 ($27,865) $1,548 $0 $1,548 ($26,317) $4,645 $0 $4,645 $101,353 $4,645 $0 $4,645 $105,998 $1,094 $0 $1,094 $17,849 $1,094 $0 $1,094 $18,943 2007 $7,287 $7,287 $0 $0 $7,287 $7,287 $91,337 $98,624 2007 $215,426 $222,713 $124,090 $124,090 $91,337 $98,624 V 4Q07 $1,548 $0 $1,548 ($24,769) $4,645 $0 $4,645 $110,643 $1,094 $0 $1,094 $20,037 $7,287 $0 $7,287 $105,911 $230,000 $124,090 $105,911 W TOTALS $51,292 $76,061 $1,548 ($24,769) $146,265 $35,622 $4,645 $110,643 $32,443 $12,406 $1,094 $20,037 $230,000 $124,090 $7,287 $105,911 $230,000 $124,090 $105,911 Benzene Health Research Consortium Fudan 1Q05 Financial Report Page 23 of41 &[DATE] SH ELL-MCCLU RG-OS2662 A SRP + ERP (X8109) Cost Centers Albertini Budgeted Actual expense CurrentVanance ~ ~ CummVanance Brody (DB5200X1503, resigned 4003) Budgeted Actual expense CurrentVanance I L Cumm Vanance Checkoway '" Budgeted Actual expense 1::1 L. CurrentVanance CummVanance Cherrie/lOM Budgeted Actual expense CurrentVanance CummVanance Greim Budgeted Actual expense L. CurrentVanance CummVanance ~Herrick ~ ")l. Budgeted Actual expense )L ~ ..)"+ CurrentVanance Cumm Vanance Idanpaan-Heikkila Budgeted ..):: Actual expense ~ CurrentVanance ~ Cumm Vanance ")C Larson ..)t1 Budgeted ~ Actual expense ~ CurrentVanance "+. CummVanance "+.: Li ~ Budgeted ~ Actual expense "+1: CurrentVanance ,,+, CummVanance ~Minden/OntarioCancerlnstitute ~ ::>l. Budgeted Actual expense CurrentVanance )L Cumm Vanance ~ Mueller (resigned 2003) ::>"+ Budgeted ::>:: ~ Actual expense CurrentVanance ~ Cumm Vanance ::>C Rice ::>t1 ~ Budgeted Actual expense ~ CurrentVanance CummVanance 0': Rockette ~ Budgeted ~ 01: Actual expense CurrentVanance CummVanance ~ Budgeted Actual expense CurrentVanance , L Cumm Vanance Clayton (joined 2004) '" Budgeted Actual expense CurrentVanance CummVanance Lombardo (joined 2004) Budgeted Actual expense CurrentVanance OL. CummVanance O~ TOTALS Budgeted Actual expense OC CurrentVanance CummulatlveVanance CUMULATIVE TOTALS Budgeted Expense Vanance B 2001 4thOtr c 2002 1st-4thOtr DIE I F 2003 1st&2ndOtr 3rdOtr 4thOtr $2,160 $2,000 $160 $160 $8,640 $0 $8,640 $8,800 $4,320 $0 $4,320 $13,120 $2,160 $0 $2,160 $15,280 $322 $2,529 ($2,207) $13,073 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $0 $4,320 $15,120 $2,160 $0 $2,160 $17,280 $322 $0 $322 $17,602 $2,160 $1,000 $1,160 $1,160 $8,640 $0 $8,640 $9,800 $4,320 $0 $4,320 $14,120 $2,160 $2,422 ($262) 1.858 $322 $0 $322 $14,180 $2,160 $0 $2,160 $2,160 $8,640 $2,122 $651. $8,678 $4,320 $0 $4,320 $12,998 $2,160 $0 $2,160 115.158 $322 $0 $322 $15,480 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $0 $4,320 $15,120 $2,160 $0 $2,160 $17,280 $322 $7,334 ($7,012) $10,268 $2,160 $2,000 $160 $160 $8,640 $0 $8,640 $8,800 $4,320 $0 $4,320 $13,120 $2,160 $0 $2,160 $15,280 $322 $4,454 ($4,132) $11,148 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $4,344 ($24) $10,776 $2,160 $180 $1,980 $12,756 $322 $0 $322 $13,078 $2,160 $2,127 $3' $3' $8,640 $0 $8,640 $8,673 $4,320 $0 $4,320 $12,993 $2,160 $2,636 ($476) $12,517 $322 $0 $322 $12,839 $2,160 $6,796 ($4,636) ($4,636) $8,640 $3,000 $5,640 $1,004 $4,320 $0 $4,320 $5,324 $2,160 $0 $2,160 $7,484 $322 $13,094 ($12,772) ($5,288) $2,160 $1,000 $1,160 $1,160 $8,640 $0 $8,640 $9,800 $4,320 $0 $4,320 $14,120 $2,160 $0 $2,160 $16,280 $322 $0 $322 $16,602 $2,160 $1,250 $910 $910 $8,640 $0 $8,640 $9,550 $4,320 $0 $4,320 $13,870 $2,160 $0 $2,160 $16,030 $322 $0 $322 $16,352 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $4,000 $320 $11,120 $2,160 $5,692 ($3,532) $7,588 $322 $2,000 ($1,678) $5,910 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $0 $4,320 $15,120 $2,160 $0 $2,160 $17,280 $322 $2,670 ($2,348) $14,932 $2,160 $2,500 ($340) ($340) $8,640 $0 $8,640 $8,300 $4,320 $1,650 $2,670 $10,970 $2,160 $6,054 ($3,894) $7,076 $322 $0 $322 $7,398 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2001 $30,240 $18,673 $11,567 $11,567 2001 $30,240 $18,673 $11,567 $0 $0 $0 $0 2002 $120,960 $5,122 $115838 $127,405 2002 $151,200 $23,795 $127,405 $0 $0 $0 $0 $60,480 $9,994 $50,486 $177,891 $211,680 $33,789 $177,891 $0 $0 $0 $0 2003 $30,240 $16,984 $13,256 $191,147 2003 $241,920 $50,773 $191,147 $0 $0 $0 $0 $4,508 $32,081 ($27,573) $163,574 $246,428 $82,854 $163,574 G 1stOtr Benzene Health Research Consortium SRP + ERP 1005 Financial Report IHI I J 2004 2ndOtr 3rdOtr 4thOtr K 1stOtr I LIM 2005 2ndOtr 3rdOtr IN 4thOtr o 1stOtr IP Q 2006 2ndOtr 3rdOtr IR 4thOtr SIT I U I V 2007 1stOtr 2ndOtr 3rdOtr 4thOtr w TOTALS ($13,073) $0 ($13,073) $0 $0 $250 $3,000 $0 $0 $0 $0 $3,401 $0 $0 $0 $250 ($401) $0 $0 $0 $250 ($151) ($151) ($151) $250 $0 $250 $99 $3,000 $0 $3,000 $3,099 $0 $0 $0 $3,099 $0 $0 $0 $3,099 $250 $0 $250 $3,349 $3,000 $0 $3,000 $6,349 $0 $0 $0 $6,349 $0 $0 $0 $6,349 $250 $0 $250 $6,599 $3,000 $0 $3,000 $9,599 $17,529 $7,930 $3,000 $9,599 ($17,602) $0 ($17,602) $0 $0 $1,500 ($1,500) ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $1,500 $0 $0 ($14,180) $0 ($14,180) $0 $0 $250 $3,000 $0 $0 $3,036 $0 $250 ($36) $0 $250 $214 $0 $0 $0 $214 $0 $0 $0 $214 $250 $0 $250 $464 $3,000 $0 $3,000 $3,464 $0 $0 $0 $3,464 $0 $0 $0 $3,464 $250 $0 $250 $3,714 $3,000 $0 $3,000 $6,714 $0 $0 $0 $6,714 $0 $0 $0 $6,714 $250 $0 $250 $6,964 $3,000 $0 $3,000 $9,964 $16,422 $6,458 $3,000 $9,964 ($15,480) $0 ($15,480) ($0) $0 $7,029 ($7,029) ($7,029) $250 $0 $250 ($6,779) $8,000 $10,229 ($2,229) ($9,008) $0 $0 $0 ($9,008) $0 $0 $0 ($9,008) $250 $0 $250 ($8,758) $8,000 $0 $8,000 ($758) $0 $0 $0 ($758) $0 $0 $0 ($758) $250 $0 $250 ($508) $6,000 $0 $6,000 $5,492 $0 $0 $0 $5,492 $0 $0 $0 $5,492 $250 $0 $250 $5,742 $2,000 $0 $2,000 $7,742 $27,122 $19,380 $2,000 $7,742 ($10,268) $0 ($10,268) $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $250 $6,000 $0 $0 $250 $2,000 $0 $0 $3338 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $4,662 $0 $0 $250 $8,000 $0 $0 $250 $6,000 $0 $0 $250 $2,000 $0 $250 $4,912 $4,912 $4,912 $5162 $13162 $1' $13162 $13,412 $19,412 $19,412 $19,412 $19,662 $21,662 $32,334 $10,672 $2,000 $21,662 ($11,148) $0 ($11,148) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $0 $415 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $2,585 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $250 $2,835 $2,835 $2,835 $3,085 $6,085 $6,085 $6,085 $6335 $9335 $9335 $9335 $9,585 $11,585 $18,454 $6,869 $2,000 $11,585 ($13,078) $0 ($13,078) $0 $0 $250 $8,000 $0 $0 $7,620 $0 $250 $380 $0 $250 $630 $0 $0 $0 $630 $0 $0 $0 $630 $250 $0 $250 $880 $8,000 $0 $8,000 $8,880 $0 $0 $0 $8,880 $0 $0 $0 $8,880 $250 $0 $250 $9,130 $8,000 $0 $8,000 $17,130 $0 $0 $0 $17,130 $0 $0 $0 $17,130 $250 $0 $250 $17,380 $8,000 $0 $8,000 $25,380 $37,524 $12,144 $8,000 $25,380 ($12,839) $0 ($12,839) $0 $0 $250 $3,000 $0 $0 $2,850 $0 $250 $150 $0 $250 $400 $0 $0 $0 $400 $0 $0 $0 $400 $250 $0 $250 $650 $3,000 $0 $3,000 $3,650 $0 $0 $0 $3,650 $0 $0 $0 $3,650 $250 $0 $250 $3,900 $3,000 $0 $3,000 $6,900 $0 $0 $0 $6,900 $0 $0 $0 $6,900 $250 $0 $250 $7,150 $2,000 $0 $2,000 $9,150 $16,763 $7,613 $2,000 $9,150 $5,288 $0 $5,288 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $4,000 $0 $0 $6,477 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3523 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $4,000 $0 $250 $3,773 $3,773 $3,773 $4,023 $14,023 $14,023 $14,023 $14,273 $24,273 $24,273 $24,273 $24,523 $28,523 $57,890 $29,367 $4,000 $28,523 ($16,602) $0 ($16,602) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $12,000 $13,000 $1,000 $2,000 $12,000 ($16,352) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $1,250 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $1,250 ($16,352) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 ($5,410) $500 ($5,910) ($0) $3,000 $3,500 ($500) ($500) $1,500 $2,500 ($1,000) ($1,500) $4,000 $6,31 ($2,311) ($3,811) $1,500 $0 $1,500 ($2,311) $1,000 $0 $1,000 ($1,311) $1,500 $0 $1,500 $189 $4,000 $0 $4,000 $4,189 $1,000 $0 $1,000 $5189 $1,000 $0 $1,000 $6,189 $1,000 $0 $1,000 $7,189 $4,000 $0 $4,000 $1,189 $1,000 $0 $1,000 $12,189 $1,000 $0 $1,000 .189 $1,000 $0 $1,000 $14,189 $3,000 $0 $3,000 $17,189 $41,692 $24,503 $3,000 $17,189 ($14,932) $0 ($14,932) $0 $0 $250 $3,000 $0 $0 $2,775 $0 $250 $225 $0 $250 $475 $0 $0 $0 $475 $0 $0 $0 $475 $250 $0 $250 $725 $3,000 $0 $3,000 $3,725 $0 $0 $0 $3,725 $0 $0 $0 $3,725 $250 $0 $250 $3,975 $3,000 $0 $3,000 $6,975 $0 $0 $0 $6,975 $0 $0 $0 $6,975 $250 $0 $250 $7,225 $2,000 $0 $2,000 $9,225 $14,670 $5,445 $2,000 $9,225 ($7,398) $0 ($7,398) $0 $0 $250 $10,000 $0 $0 $0 $0 $10,575 $0 $0 $0 $250 ($575) $0 $0 $0 $250 ($325) ($325) ($325) $250 $0 $250 ($75) $10,000 $0 $10,000 $9,925 $0 $0 $0 $9,925 $0 $0 $0 $9,925 $250 $0 $250 $10,175 $10,000 $0 $10,000 $20,175 $0 $0 $0 $20,175 $0 $0 $0 $20,175 $250 $0 $250 $20,425 $2,000 $0 $2,000 $22,425 $43,204 $20,779 $2,000 $22,425 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $13,000 $0 $0 $0 $6,009 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $6,009 $0 $0 $250 ($3,009) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $3,000 $0 $0 $250 ($2,759) ($2,759) ($2,759) ($2,509) $491 $491 $491 $741 $3,741 $3,741 $3,741 $3991 $6,991 $6,991 $0 $0 $0 $0 ($163,074) $500 ($163,574) $0 $83,354 $83,354 ($0) $0 $0 $0 $0 2004 $3,000 $12,029 ($9,029) ($9,029) 2004 $86,354 $95,38: ($9,029) $250 $0 $250 $250 $4,500 $2,500 $2,000 ($7,029) $90,854 $97,883 ($7,029) $3,000 $5,853 ($2,853) ($2,603) $69,000 $68,889 ($6,917) $159,854 $166,772 ($6,918) $0 $0 $0 ($:,603) $1,500 $0 $1,500 ($5,417) $161,354 $166,772 ($5,418) $0 $0 $0 ($203) $250 $0 $250 ($2,353 2005 $1,000 $4,500 $0 $0 $1,000 $4,500 ($4,417) $83 2005 $162,354 $166,854 $166,772 $166,772 ($4,418) $82 $3,000 $0 $3,000 $647 $69,000 $0 $69,000 $69,083 $235,854 $166,772 $69,082 $0 $0 $0 $647 $1,000 $0 $1,000 $70,083 $236,854 $166,772 $70,082 $0 $0 $0 $647 $250 $0 $250 $897 2006 $1,000 $4,000 $0 $0 $1,000 $4,000 $71,083 $75,083 2006 $237,854 $241,854 $166,772 $166,772 $71,082 $75,082 $3,000 $0 $3,000 $3,897 $65,000 $0 $65,000 $140,083 $306,854 $166,772 $140,082 $0 $0 $0 $3,897 $1,000 $0 $1,000 $141,083 $307,854 $166,772 $141,082 $0 $0 $0 $3,897 $250 $0 $250 $4,147 2007 $1,000 $4,000 $0 $0 $1,000 $4,000 $142,083 $146,083 2007 $308,854 $312,854 $166,772 $166,772 $142,082 $146,082 $3,146 $0 $3,146 $7,293 $13,146 $5,853 $3,146 $7,293 $38,000 $0 $38,000 $184,083 $350,854 $166,772 $38,000 $184,083 $350,854 $166,772 $184,082 $350,854 $166,772 $184,082 0'" 'Tel SH ELL-MCCLU RG-OS2663 A IBI c I D I E Blue fulure cumulallvevanance has no meaning unlll Expense enlered F Benzene Health Research Consortium SRP + ERP 1005 Financial Report G H I J KI L M N 0 PQ RS TUV W 93 ::1"1 95 LT10/20/04 96 BJ4/05/05 II II I I I I 1Q04budget ajustmentslo zeroourvanance I~CoefC" omme I~;~:~~I~;rs~f I~~;;:~ I:;~;~:;o~by OC meeting DRAFT I I Page 25 of41 &[DATE] SH ELL-MCCLU RG-OS2664 Benzene Health Research Consortium Communications 1Q05 Financial Report ~ ~ APCO "I Budgeted Actual expense CurrentVariance Cumm Variance Travel ~ Budgeted Actual expense CurrentVariance Cumm Variance Other L<L Budgeted ~ Actual expense CurrentVariance Cumm Variance A COMMUNICATIONS Cost Centers B 2001 lst- 4th OtL CD 2002 lst- 4th OtL 1st & 2nd OtL E 2003 3rd OtL $57,600 $0 $57,600 $57,600 $230,400 $232,229 ($1,829) $55,771 $120,000 $14,483 $105,517 $161,288 $60,000 $7,351 $52,649 $213,937 $1,800 $0 $1,800 $1,800 $7,200 $7,091 $109 $1,909 $3,750 $0 $3,750 $5,659 $1,875 $526 $1,349 $7,008 $600 $0 $600 $600 $2,400 $1,417 $983 $1,583 $1,250 $80 $1,170 $2,753 $625 $0 $625 $3,378 G:L '[ ~ ~ ~"I L~ ~ Budgeted Actual expense CurrentVariance Cumm Variance Budgeted Actual expense CurrentVariance Cumm Variance $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 L~ Budgeted $0.00 ~ Actual expense ~ CurrentVariance Cumm Variance $0.00 $0.00 $0.00 .)~ ~ ~ .)t Budgeted Actual expense CurrentVariance $0.00 $0.00 $0.00 ;j, Cumm Variance $0.00 ~ ~ "I~ 4' Budgeted Actual expense CurrentVariance TOTALS 2001 $60,000 $0 $60,000 ~ Cumm Variance ~ CUMULATIVE TOTALS "1"1 Budgeted 2001 $60,000 $60,000 4~ Expense $0 "10 Variance $60,000 "I, - Telecommunications, Consulting Services, Duplicating/Copies Internal, Postage, Couriers, Telephone, Meals, Lexis Nexis Searches ~ Blue: future cumulative variance has no meaning until Expense entered. ~ "- Budget adjustment reflects budget reduction from $1 MM to $550k :)~ o LT 1/28/05 )L RT 1/21/05 'budget adjustment to lower program budget from $550K to $300K, as approved by OC on $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2002 $240,000 $240,738 ($738) $59,262 2002 $300,000 $240,738 $59,262 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $125,000 $14,564 $110,436 $169,699 $425,000 $255,301 $169,699 $0.00 $0.00 $0.00 $0.00 2003 $62,500 $7,877 $54,623 $224,322 2003 $487,500 $263,178 $224,322 Page 26 of41 &[DATE] SH ELL-MCCLU RG-052665 Benzene Health Research Consortium Communications 1Q05 Financial Report F ~ 4lh OIL" ~ "I ($187,396) $26,541 ($213,937) ($0) ~ ($5,876) $1,132 ($7,008) $0 L<L ($3,364) ~ $15 ($3,379) ($2 G 1sl0lL $14,401 $0 $14,401 $14,401 $450 $0 $450 $450 $150 $0 $150 $148 HI 2004 2nd OIL 3rd OIL J 4lh Olr' K 1sl0lL LM 2005 2nd OIL 3rd OIL N 4lh OIL 0 1sl0lL PQ 2006 2nd OIL 3rd OIL R 4lh OIL" $14,400 $14,400 ($39,906) $790 $1,235 $1,270 $0 $0 $0 $0 $0 $0 $0 $0 $13,610 $13,165 ($41,176) $0 $0 $0 $0 $0 $0 $0 $0 $28,011 $41,176 ($0) ($0) ($0) ($0) ($0) ($0) ($0) ($0) ($0) $450 $450 ($1,350) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $450 $450 ($1,350) $0 $0 $0 $0 $0 $0 $0 $900 $1,350 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $150 $150 ($448) $1,946 $1,946 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $150 $150 ($448) $0 $0 $0 $1,946 $0 $0 $0 $1,946 $298 $448 $0 $0 $0 $0 $1947 $1,947 $1,947 $1,947 $3,893 S 1sl0lL TU 2007 2nd OIL 3rd OIL V 4lh OIL $0 $0 $0 $0 $0 $0 $0 $0 ($0) ($0) ($0) ($0) $0 $0 $0 $0 $0 $3,893 $0 $0 $0 $0 $0 $3,893 $0 $0 $0 $0 $0 $3,893 $0 $0 $0 $1,946 $0 $1,946 $5,839 W TOTALS $283,899 $283,899 ($0) ($0) $8,749 $8,749 $0 $0 $7,352 $1,513 $5,839 $5839 G:L '[ ~ ~ ~"I L~ ~ $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 L~ ~ ~ .)~ ~ ~ .)t ;j, ~ ~ "I~ 4' ~ ~ "1"1 4~ "10 "I, ~ ~ :)~ o )L $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 ($196,636) $27,688 ($224,324) ($2) $290,864 $290,866 ($2) $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $15,001 $0 $15,001 $14,999 $305,865 $290,866 $14,999 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2004 $15,000 $15,000 $790 $1,235 $14,210 $13,765 $29,209 $42,974 2004 $320,865 $335,865 $291,656 $292,891 $29,209 $42,974 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 ($41,704) $1,270 ($42,974) $0 $0 $0 $0 $0 $294,161 $294,161 $294,161 $294,161 $0 $0 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2005 $0 $0 $0 $0 $0 $0 $0 $0 2005 $294,161 $294,161 $294,161 $294,161 $0 $0 $0.00 $0.00 $0.00 $0.00 $1,946 $0 $1,946 $1,946 $296,107 $294,161 $1,946 $0.00 $0.00 $0.00 $0.00 $0 $0 $0 $1,946 $296,107 $294,161 $1,946 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2006 $0 $0 $0 $0 $0 $0 $1,946 $1,946 2006 $296,107 $296,107 $294,161 $294,161 $1,946 $1,946 DRAFT $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $1,946 $0 $1,946 $3,893 $298,054 $294,161 $3,893 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0 $0 $0 $3,893 $298,054 $294,161 $3,893 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2007 $0 $0 $0 $0 $0 $0 $3,893 $3,893 2007 $298,054 $298,054 $294,161 $294,161 $3,893 $3,893 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $1,946 $0 $1,946 $5,839 $300,000 $294,161 $5,839 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $300,000 $294,161 $3,893 $5,839 $300,000 $294,161 $5,839 Page 27 of41 &[DATE] SH ELL-MCCLU RG-OS2666 Benzene Health Research Consortium Legal 1Q05 Financial Report A LEGAL Cost Centers Steptoe &Johnson "I Budgeted .2 Actual expense ~ CurrentVariance Cumm Variance B 2001 1st-4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. $30,000 $0 $30,000 $30,000 $120,000 $13,565 $106,435 $136,435 $62,500 $1,728 $60,772 $197,207 ~ ~ Budgeted Expense Variance Blue: future cumulative variance has no 12 meaning until Expense entered. $30,000 $0 $30,000 $150,000 $13,565 $136,435 $212,500 $15,293 $197,207 * budget adjustment to lower program budget from $500K to $1 OOK, as approved 14 by DC on 11/11/03 12 ~ LT7/19/04 RT 04113105 E 2003 3rd Qtr. $31,250 $0 $31,250 $228,457 $243,750 $15,293 $228,457 F 4th Qtr.* G 1stQtr. HI 2004 2nd Qtr. 3rd Qtr. ($210,542) $17,915 ($228,457) $0 $4,175 $365 $3,810 $3,810 $4,175 $2,995 $1,180 $4990 $4,175 $1,870 $2,305 $7,294 $33,208 $33,208 $0 $37,383 $33,572 $3,810 $41,557 $36,567 $4,990 $45,732 $38,437 $7,294 J 4thQtr. K 1stQtr. LM 2005 2nd Qtr. 3rd Qtr. N 4thQtr. $4,175 $26,092 ($21,918) ($14,623) $4,175 $4,827 ($653) ($15,276) $4,175 $0 $4,175 ($11101) $4,175 $0 $4,175 ($6,927) $4,175 $0 $4,175 ($2,752 0 1stQtr. PQ 2006 2nd Qtr. 3rd Qtr. $4,175 $0 $4,175 $1,422 $4,175 $0 $4,175 $5,597 $4,175 $0 $4,175 $9,771 $49,906 $64,529 ($14,623) $54,081 $69,356 ($15,276) $58,255 $69,356 ($11,101) $62,430 $69,356 ($6,927) $66,604 $69,356 ($2,752) $70,779 $69,356 $1,422 $74,953 $69,356 $5,597 $79,128 $69,356 $9,771 DRAFT R 4thQtr. $4,175 $0 $4,175 $13946 $83,302 $69,356 $13,946 S 1stQtr. TU 2007 2nd Qtr. 3rd Qtr. $4,175 $0 $4,175 $18120 $4,175 $0 $4,175 $22,295 $4,175 $0 $4,175 $26,469 $87,477 $69,356 $18,120 $91,651 $69,356 $22,295 $95,826 $69,356 $26,469 V 4thQtr. $4,175 $0 $4,175 $30,644 $100,000 $69,356 $30,644 Page 28 of41 &[DATE] SH ELL-MCCLU RG-OS2667 W TOTALS L. --zt $100,000 0 $69,356 $30,644 $30,644 --g- $100,000 IU $69,356 $30,644 12 14 f5" 10 Benzene Health Research Consortium Legal 1Q05 Financial Report Page 29 of41 &[DATE] SH ELL-MCCLU RG-OS2668 Benzene Health Research Consortium QA-QC 1Q05 Financial Report A QA-QC ~ Cost Centers ~ Contractor "I Budgeted 0 Actual expense ~ CurrentVariance Cumm Variance Travel ~ Budgeted LlL Actual expense CurrentVariance Cumm Variance Budgeted L<l Actual expense 12 CurrentVariance Cumm Variance BC D 2001 2002 1st- 4th OtL 1st- 4th OtL 1st & 2nd OtL E 2003 3rd OtL F 4th OtL G 1stOtL HI 2004 2nd OtL 3rd OtL J 4th Otr" KLM 2005 1stOtL 2nd OtL 3rd OtL N 4th OtL 0 1stOtL PQ 2006 2nd OtL 3rd OtL R 4th OtL S 1stOtL TU 2007 2nd OtL 3rd OtL V 4th OtL $13,500 $0 $13,500 $13,500 $54,000 $0 $54,000 $67,500 $28,126 $0 $28,126 $95,626 $14,063 $0 $14,063 $109,689 ($109,689) $0 ($109,689) $0 $6,250 $0 $6,250 $6,250 $6,250 $0 $6,250 $12,500 $6,250 $0 $6,250 $18,750 ($18,750) $0 ($18,750) $0 $4,167 $0 $4,167 $4,167 $4,167 $0 $4,167 $8,333 $4,167 $0 $4,167 $12,500 $4,167 $0 $4,167 $16,667 $4,167 $0 $4,167 $20,833 $4,167 $0 $4,167 $25,000 $4,167 $0 $4,167 $29,167 $4,167 $0 $4,167 $33,333 $4,167 $0 $4,167 $37,500 $4,167 $0 $4,167 $41,667 $4,167 $0 $4,167 $45,833 $4,167 $0 $4,167 $50,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 ~ ~ L' l. ~ ~ L"I l.o ~ ., L, l.~ ~ Budgeted Actual expense CurrentVariance Cumm Variance Budgeted Actual expense CurrentVariance Cumm Variance Budgeted Actual expense CurrentVariance Cumm Variance $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 ;j;j Budgeted ~ ~ ,)0 Actual expense CurrentVariance Cumm Variance ;j, TOTALS ~ Budgeted ~ Actual expense "IU CurrentVariance 4' Cumm Variance ~ CUMULATIVE TOTALS ~ Budgeted "1"1 Expense 40 Variance Dlue: u ure cumu a Ive variance has no meaning 46 until Expense entered. 4, $0 $0 $0 $0 2001 $13,500 $0 $13,500 $13,500 2001 $13,500 $0 $13,500 $0 $0 $0 $0 2002 $54,000 $0 $54,000 $67,500 2002 $67,500 $0 $67,500 $0 $0 $0 $0 $28,126 $0 $28,126 $95,626 $95,626 $0 $95,626 * budget adjustment to lower program ** budget adjustment to lower program budget from $225K to $1 OOK, as budget from $100K to $50K, as approved 48 approved by DC on 11/11/03 by OC on 12/16/04 4~ OL LT 1128105 $0 $0 $0 $0 2003 $14,063 $0 $14,063 $109,689 2003 $109,689 $0 $109,689 $0 $0 $0 $0 ($109,689) $0 ($109,689) $0 $0 $0 $0 $0 $0 $0 $0 $6,250 $0 $6,250 $6,250 $6,250 $0 $6,250 $0 $0 $0 $0 $0 $0 $0 $0 2004 $6,250 $6,250 $0 $0 $6,250 $6,250 $12,500 $18,750 2004 $12,500 $18,750 $0 $0 $12,500 $18,750 $0 $0 $0 $0 $0 $0 $0 $0 ($18,750) $0 ($18,750) $0 $4,167 $0 $4,167 $4,167 $0 $4,167 $0 $0 $0 $4,167 DRAFT $0 $0 $0 $0 $0 $0 $0 $0 2005 $4,167 $4,167 $0 $0 $4,167 $4,167 $8,333 $12,500 2005 $8,333 $12,500 $0 $0 $8,333 $12,500 $0 $0 $0 $0 $4,167 $0 $4,167 $16,667 $16,667 $0 $16,667 $0 $0 $0 $0 $4,167 $0 $4,167 $20,833 $20,833 $0 $20,833 $0 $0 $0 $0 $0 $0 $0 $0 2006 $4,167 $4,167 $0 $0 $4,167 $4,167 $25,000 $29,167 2006 $25,000 $29,167 $0 $0 $25,000 $29,167 $0 $0 $0 $0 $4,167 $0 $4,167 $33,333 $33,333 $0 $33,333 $0 $0 $0 $0 $4,167 $0 $4,167 $37,500 $37,500 $0 $37,500 $0 $0 $0 $0 $0 $0 $0 $0 2007 $4,167 $4,167 $0 $0 $4,167 $4,167 $41,667 $45,833 2007 $41,667 $45,833 $0 $0 $41,667 $45,833 $0 $0 $0 $0 $4,167 $0 $4,167 $50,000 $50,000 $0 $50,000 Page 30 of41 &[DATE] SH ELL-MCCLU RG-OS2669 W TOTALS ~ ~ "I $50,000 0 $0 ~ $50,000 $50,000 ~ $0 LlL $0 $0 $0 $0 L<l $0 12 $0 $0 ~ ~ L' l. ~ ~ L"I l.o ~ ., L, l.~ ~ $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 ;j;j ~ ~ ,)0 ;j, ~ ~ "IU 4' ~ ~ "1"1 40 $0 $0 $0 $0 $50,000 $0 $50,000 $50,000 $50,000 $0 $50,000 46 4, 48 4~ OL Benzene Health Research Consortium QA-QC 1Q05 Financial Report Page 31 of41 &[DATE] SH ELL-MCCLU RG-052670 A API Cost Centers Salaries ~ Budgeted .2 Actual expense CurrentVariance Cumm Variance ~ Employee Benefits ~ Budgeted Actual expense CurrentVariance ~ Cumm Variance ~ Travel 1"1 Budgeted 10 Actual expense ~ CurrentVariance Cumm Variance Other Operating Expenses (& mtgs) I~ Budgeted ~ Actual expense -. CurrentVariance L. Cumm Variance L API Recovered Overhead ~ Budgeted ~ L' Actual expense CurrentVariance l. Cumm Variance ~ API Allocated Costs ~ Budgeted ,)u Actual expense ;j' CurrentVariance ~ Cumm Variance ~ Supported Expense ,)"1 Budgeted ;jo Actual expense ~ .", CurrentVariance Cumm Variance ;jts rALS ;j~ Budgeted ~ ~ ~ Actual expense CurrentVariance Cumm Variance 4;j CUMULATIVE TOTALS ~ ~ "It Budgeted Expense Variance "I, ~ LT 4/24/05 ~ RT 04/13/05 :>u Assumptions: ~ Year 5, 6,7 Less than 1 FTE al/ocated, based al/ocated cost on 112 FTE ~ T&E and Other $15K for Annual Meeting (3rd Quarter) :>"1 Sup,:,orted Ex. ense dro off Jeft some funds for consultant Benzene Health Research Consortium API Administration 1Q05 Financial Report B C D E IF 2000 2001 2002 2003 Ist- 4th OtL Ist- 4th OtL Ist- 4th OtL 1st & 2nd OtL 3rd OtL G 4th OtL H IstOtL IJ 2004 2nd OtL 3rd OtL K 4th OtL L IstOtL MN 2005 2nd OtL 3rd OtL 0 4th OtL P IstOtL $0 $9,039 ($9,039) ($9,039) $26,045 $18,749 $6,552 ($2,487) $104,180 $89,669 $14,511 $12,024 $54,260 $57,297 ($3,037) $8,987 $27,130 $32,217 ($5,087) $3,900 $22,250 $32,800 ($10,550) ($6,650) $22,000 $26,745 ($4,745) ($11,395) $22,000 $25,357 ($3,357) ($14,752) $22,000 $21,839 $161 ($14,591) $20,000 $21,813 ($1,813) ($16,404) $12,000 $16,492 ($4,492) ($20,896) $10,000 $0 $10,000 ($10,896) $14,000 $0 $14,000 $3,104 $10,000 $0 $10,000 $13,104 $12,000 $0 $12,000 $25,104 $0 $774 ($774) ($774) $3,256 $2,329 $927 $153 $13,022 $11,209 $1,813 $1,966 $ 6,783 $ 3,391 $7,163 $4,027 ($380) $ (636) $1,586 $950 $2,750 $ 3,000 $ 3,000 $ 3,000 $4,100 $3,343 $3,169 $2,730 ($1,350) ($343) $ (169) $270 ($400) ($743) ($912) ($642) $2,900 $2,727 $173 ($469) $1,100 $2,061 ($961) ($1,430) $1,000 $0 $1,000 ($430) $1,400 $0 $1,400 $970 $1,000 $0 $1,000 $1,970 $1,100 $0 $1,100 $3,070 $0 $342 ($342) ($342) $3,256 $1,487 $1,769 $1,427 $13,022 $8,004 $5,018 $6,445 6,783 $308 $6,475 $12,920 $3,391 $1,683 $1,708 $14,628 $7,500 $7,313 $187 $14,815 1,000 $0 $1,000 $15,815 $1,000 $1,152 ($152) $15,663 $3,000 $2,027 $973 $16,636 $1,000 $1,710 ($710) $15,926 $1,000 $716 $284 $16,210 $1,000 $0 $1,000 $17,210 $5,000 $0 $5,000 $22,210 $1,000 $0 $1,000 $23,210 $1,000 $0 $1,000 $24,210 $0 $1,673 ($1,673) ($1,673) $651 $9,196 ($8,545) ($10,218) $2,604 $16,270 ($13,666) ($23,884) $1,359 $13,292 ($11,933) ($35,817) $679 $72 $607 ($35,210) $16,184 $26,276 ($10,092) ($45,302) $2,000 $3,600 ($1,600) ($46,902) $2,000 $3,808 ($1,808) ($48,710) $6,000 ($3,223) $9,223 ($39,487) $2,000 $11,398 ($9,398) ($48,885) $430 $2,010 ($1,580) ($50,465) $430 $0 $430 ($50,035) $5,000 $0 $5,000 ($45,035) $400 $0 $400 ($44,635) $400 $0 $400 ($44,235) $0 $5,752 ($5,752) ($5,752) $8,465 $4,687 $3,778 ($1,974) $33,858 $25,110 $8,748 $6,774 $ 17,635 $16,043 $1,592 $8,366 $ 8,817 $9,021 ($204) $8,162 $6,250 $ 6,200 $ 6,200 $ 6,200 $ 6,000 $9,185 $7,489 $7,099 $6,115 $6,107 ($2,935) ($1,289) ($899) $85 ($107) $5,227 $3,938 $3,039 $3,124 $3,017 $3,500 $4,618 ($1,118) $1,899 $3,000 $0 $3,000 $4,899 $4,000 $0 $4,000 $8,899 $3,000 $0 $3,000 $11,899 $3,500 $0 $3,500 $15,399 $0 $16,929 $67,717 $0 $13,886 $58,794 $0 $3,043 $8,923 $0 $3,043 $11,966 $35,269 $34,213 $1,056 $13,022 $17,635 $19,478 ($1,843) $11,179 $15,250 $17,231 ($1,981) $9,198 $28,000 $28,000 $0 $9,198 $28,000 $27,999 $1 $9,199 $28,000 $28,000 $0 $9,199 $28,000 $27,999 $1 $9,200 $10,000 $6,999 $3,001 $12,201 $10,000 $0 $10,000 $22,201 $10,000 $0 $10,000 $32,201 $10,000 $0 $10,000 $42,201 $10,000 $0 $10,000 $52,201 $0 $7,020 ($7,020) $7020 2000 $0 $24,600 ($24,600) ($24,600) 2000 $0 $24,600 ($24,600) $6,511 $1,712 $4,799 $2,221 2001 $65,113 $52,046 $13,067 $11,533 2001 $65,113 $76,646 ($11,533) $26,045 $0 $26,045 $23824 $ 13,565 $17,000 ($3,435) $LO 389 $ 6,783 $8,499 ($1,716) $18673 $5,750 $ 4,500 $ 4,500 ($8,250) ($4,023) $4,500 $14,000 $8,523 $0 $32673 $41 196 $41 196 $4,500 $4,500 $0 $41 196 200 $260,448 $209,056 $51,392 $39,859 2003 $135,654 $145,316 ($9,662) $30,197 $67,826 $74,997 ($7,171) $23,026 $75,934 $88,655 ($12,721) $10,305 2004 $66,700 $65,154 $1,546 $11,851 $66,700 $73,084 ($6,384) $5,467 $72,700 $61,988 $10,712 $16,179 2002 $325,561 $285,702 $39,859 2003 $461,215 $431,018 $30,197 $529,041 $506,015 $23,026 $604,975 $594,670 $10,305 2004 $671,675 $659,824 $11,851 $738,375 $732,908 $5,467 $811,075 $794,896 $16,179 $4,500 $4,500 $0 $41 196 $64,400 $76,254 ($11,854) $4,325 $875,475 $871,150 $4,325 $1,250 $4,500 ($3,250) $37946 $29,280 $37,396 ($8,116) $3,791 $904,755 $908,546 ($3,791) $1,250 $0 $1,250 $39196 $1,250 $0 $1,250 $40446 2('05 $26,680 $40,650 $0 $0 $26,680 $40,650 $22,889 $63,539 2005 $931,435 $972,085 $908,546 $908,546 $22,889 $63,539 $1,250 $0 $1,250 $41 696 $1,250 $0 $1,250 $42946 $26,650 $0 $26,650 $90,189 $29,250 $0 $29,250 $119,439 $998,735 $1,027,985 $908,546 $908,546 $90,189 $119,439 DRAFT Page 32 of41 &[DATE] SHELL-MCCLURG-052671 Benzene Health Research Consortium API Administration 1Q05 Financial Report Q I RIs 2006 2nd OIL 3rd OIL 4lh OIL TI u I v Iw 2007 1sl0lL 2nd OIL 3rd OIL 4lh OIL ~ $10,000 .2 $0 $10,000 $35,104 ~ ~ $1,000 $0 $1,000 ~ $4,070 ~ 1"1 $1,000 10 $0 ~ $1,000 $25,210 $14,000 $0 $14,000 $49,104 $1,400 $0 $1,400 $5,470 $5,000 $0 $5,000 $30,210 $10,000 $0 $10,000 $59,104 $1,000 $0 $1,000 $6,470 $1,000 $0 $1,000 $31,210 $12,000 $0 $12,000 $71,104 $1,100 $0 $1,100 $7,570 $1,000 $0 $1,000 $32,210 $10,000 $0 $10,000 $81,104 $1,000 $0 $1,000 $8,570 $1,000 $0 $1,000 $33,210 $14,000 $0 $14,000 $95,104 $1,400 $0 $1,400 $9,970 $5,000 $0 $5,000 $38,210 $10,000 $0 $10,000 $105,104 $1,000 $0 $1,000 $10,970 $1,000 $0 $1,000 $39,210 I~ ~ -. L. L ~ ~ L' l. ~ ~ .,)u ;j' ~ ~ ,,)"1 ;jo ~ .", ;jts ;j~ ~ ~ "IL 4;j ~ ~ "It "I, ~ ~ :>u $400 $0 $400 ($43,835) $5,000 $0 $5,000 ($38,835) $400 $0 $400 ($38,435) $400 $0 $400 ($38,035) $400 $0 $400 ($37,635) $5,000 $0 $5,000 ($32,635) $400 $0 $400 ($32,235) $3,000 $0 $3,000 $18,399 $4,000 $0 $4,000 $22,399 $3,000 $0 $3,000 $25,399 $3,500 $0 $3,500 $28,899 $3,000 $0 $3,000 $31,899 $4,000 $0 $4,000 $35,899 $3,000 $0 $3,000 $38,899 $10,000 $0 $10,000 $62,201 $10,000 $0 $10,000 $72,201 $10,000 $0 $10,000 $82,201 $10,000 $0 $10,000 $92,201 $10,000 $0 $10,000 $102,201 $10,000 $0 $10,000 $112,201 $10,000 $0 $10,000 $122,201 $1,250 $1,250 $0 $0 $1,250 $1,250 $44,196 $45,446 2006 $26,650 $40,650 $0 $0 $26,650 $40,650 $146,089 $186,739 2006 $1,054,635 $1,095,285 $908,546 $908,546 $146,089 $186,739 $1,250 $0 $1,250 $46,696 $26,650 $0 $26,650 $213,389 $1,121,935 $908,546 $213,389 $1,250 $1,250 $1,250 $0 $0 $0 $1,250 $1,250 $1,250 $47,946 $49,196 $50,446 2007 $29,250 $26,650 $40,650 $0 $0 $0 --$29,250 $242,639 $908,546 $26,650 $40,650 $269,289 $309,939 2007 $1,177,835 $1,218,485 $908,546 $908,546 $242,639 $269,289 $309,939 $1,250 $0 $1,250 $51,696 $26,650 $0 $26,650 $336,589 $1,245,135 $908,546 $336,589 ~ ~ :>"1 X TOTALS $411,865 $342,978 $68,143 $68,887 $54,602 $42,858 $11,744 $11,744 $63,952 $24,400 $39,552 $39,552 $52,137 $82,699 ($30,562) ($30,562) $140,125 $95,474 $44,651 $44,651 $384,800 $262,599 $122,201 $122,201 $91,654 $32,938 $58,716 $58,716 $1,245,135 $883,946 $361,189 $361,189 $1,245,135 $908,546 $336,589 Page 33 of41 &[DATE] SH ELL-MCCLU RG-OS2672 A L ;j Continaencv Funds ~ 2 Budgeted Actual expense CurrentVariance Cumm Variance --"L Reallocations from UCHSC Budgeted Actual expense 1 CurrentVariance Cumm Variance 1"1 Reallocations from AHS Budgeted Actual expense CurrentVariance Cumm Variance Histopath Review - J. Bennett ~ Budgeted ... Actual expense ~L CurrentVariance L;j Cumm Variance ~ Krieger ~ Budgeted Actual expense L CurrentVariance ~ Cumm Variance ~ Non-contract ')L Budgeted ;j' Actual expense ;g CurrentVariance Cumm Variance ,)"1 ;j~ Budgeted ~ ~ ')C Actual expense CurrentVariance Cumm Variance ;j~ IAL:; ~ Budgeted ~ Actual expense "IL CurrentVariance 4;j Cumm Variance ~ CUMULATIVE TOTALS ~ Budgeted "It Expense 4f Variance "IC 4~ ~ LT 4/10/05 2 OL o;j ~ Benzene Health Research Consortium Contingency Fund 1Q05 Financial Report B C D EF 2000 1st- 4th OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 'UU $0.00 $0.00 $0.00 $0.00 2000 $0.00 $0.00 $0.00 2001 1st- 4th OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $0.00 2001 $0.00 $0.00 $0.00 2002 1st- 4th OtL 1st & 2nd OtL 3rd OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2,002 0 0 0 0 0 0 0 00 00 00 00 00 00 00 2003 G 4th OtL 2UU 2,003 $290,272 $0 $290,272 $290,272 $0 $48,839 ($48,839) ($48,839) $0 $52,634 ($52,634) ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 290,272 101,473 188,799 188,799 290,272 101,473 188,799 4Q03 Adjustment - per Technical Committee, transfer $48,839 from UCHSC expense detail to contingency because expenses not part of UCHSC g AHS - expense transfer of $52 634 from AHS ex ense detail to continqenc because ex enses not part of AHS full study bud et Page 34 of 41 &[DATE] SH ELL-MCCLU RG-052673 Benzene Health Research Consortium Contingency Fund 1Q05 Financial Report H L 2004 ;j 1stOtr. ~ 2 --"L 1 1"1 ~ ... ~L L;j ~ ~ L ~ ~ ')L ;j' ;g ,)"1 ;j~ ~ ~ ')c ;j~ ~ ~ "IL 'U4 4;j ~ ~ "It 4f 2,004 "IC i nt budget: OL 1. June 2001 $25K grant to UCHSC; seed money exhausted (API & sponsor), expense not included in final grant cost estimate o;j 2. $3600 IRS fees to U of CO (this will be a yearly fee, since IRS must review at least once per year) ~ 3. 2002 invoice ($20,239) from EMBSI for final feasibility study work (very late billing to API) I J K LMN0 PQ $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 0 0 0 188,799 0 101,473 188,799 2nd Otr. $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 0 0 0 188,799 0 101,473 188,799 3r.d Otr. $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 0 0 0 188,799 0 101,473 188,799 4th Otr. $300,000 $0 $300,000 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $3,000 ($3,000) ($3,000) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 300,000 3,000 297,000 485,799 300,000 104,473 485,799 1stOtr. $0 $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $3,000 ($3,000) ($6,000) $0 $0 $0 $0 $0 $496 ($496) ($496) $0 $0 $0 $0 0 3,496 -3,496 482,303 0 107,969 -107,969 2005 2nd Otr. 3r.d Otr. $0 $0 $0 $590,272 $0 $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($52,634) $0 $0 $0 ($6,000) $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 ($496) $0 $0 $0 $0 2l 0 0 0 482,303 2,005 0 0 0 $0 $0 $0 $0 0 0 0 482,303 0 0 0 4th Otr. $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 $0 0 0 0 482,303 0 0 0 1stOtr. $0 $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 $0 2 2nd Otr. $0 $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 $0 0 0 0 482,303 0 0 0 0 0 0 482,303 2, 0 0 0 DRAFT Page 35 of 41 &[DATE] SH ELL-MCCLU RG-OS2674 Benzene Health Research Consortium Contingency Fund 1Q05 Financial Report R L 06 ;j 3rd Olr ~ 2 $0 $0 $0 $590,272 --"L $0 $0 1 $0 ($48,839) 1"1 $0 $0 $0 ($52,634) ~ ... ~L L;j ~ ~ L ~ ~ ')L ;j' ;g ,)"1 ;j~ ~ ~ ')c ;j~ ~ ~ "IL 06 4;j ~ 06 ~ "It 4f "IC 4~ ~ 2 OL o;j ~ $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 $0 0 0 0 482,303 0 0 0 S 4lh Olr $0 $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 $0 0 0 0 482,303 0 0 0 TUV 1sl0lr $0 $0 $0 $590,272 $0 $0 $0 ($48,839) 2007 2nd Olr 3rd Olr $0 $0 $0 $590,272 $0 $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($52,634) $0 $0 $0 ($52,634) $0 $0 $0 ($6,000) $0 $0 $0 ($6,000) $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 $0 0 0 0 482,303 0 0 0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 ($496) $0 $0 $0 $0 2007 0 0 0 482,303 2,007 0 0 0 $0 $0 $0 $0 0 0 0 482,303 0 0 0 W 4lh Olr $0 $0 $0 $590,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($6,000) $0 $0 $0 $0 $0 $0 $0 ($496) $0 $0 $0 $0 0 0 0 482,303 0 0 0 X TOTALS $590,272 $0 $0 $590,272 $0 $48,839 $0 ($48,839) $0 $52,634 $0 ($52,634) $0 $6,000 $0 ($6,000) $0 $0 $0 $0 $0 $496 $0 ($496) $0 $0 $0 $0 590,272 107,969 0 482,303 0 0 0 Page 36 of 41 &[DATE] SH ELL-MCCLU RG-052675 A ~ ~ INCOME "I Sponsor Payments API Interest UCHSC Interest TOTALS Reporting Period ~ Cumulative 1 projected income ~ 1"1 LT 7/19/04 RT 04/05/05 Benzene Health Research Consortium Income 1Q05 Financial Report B 2000 1st - 4th Qtr. C 2001 1st - 4th Qtr. D 2002 1st - 4th Qtr. E 1st & 2nd Qtr. F 2003 3rd Qtr. G 4th Qtr. H 1stQtr. IJ 2004 2nd Qtr. 3rd Qtr. K 4th Qtr. L 1stQtr. MN 2005 2nd Qtr. 3rd Qtr. 0 4th Qtr. P 1stQtr. QR 2006 2nd Qtr. 3rd Qtr. $60,000 $246 $0 $2,105,509 $7,623 $0 $8,355,629 $11,817 $0 $448,024 $0 $0 $0 $ $3,186 $0 4,259,965 $5,276 $0 $1,485,875 $ $0 $0 $6,746 $6,506 $9,292 $1,096,000 $60,246 $60,246 $2,113,132 $2,173,378 $8,367,446 $10,540,824 $448,024 $10,988,848 $3,186 $10,992,034 $4,265,241 $1,485,875 $15,257,275 $16,743,149 $6,746 $6,506 $16,749,895 $16,756,401 $9,292 $1,096,000 $0 $0 $0 $0 $0 $0 $16,765,693 $17,861,693 $17,861,693 $17,861,693 $17,861,693 $17,861,693 $17,861,693 $17,861,693 DRAFT Page 37 of41 &[DATE] SH ELL-MCCLU RG-052676 S ~ 4th Qtr. ~ "I T 1stQtr. UV 2007 2nd Qtr. 3rd Qtr. W 4th Qtr. X TOTALS $17,811,001 $50,692 $0 $0 $0 $0 $0 $0 $17,861,693 ~ $17,861,693 $17,861,693 $17,861,693 $17,861,693 $17,861,693 1 ~ 1"1 Benzene Health Research Consortium Income 1Q05 Financial Report Page 38 of41 &[DATE] SH ELL-MCCLU RG-OS2677 A T 2 Company Name 3 BP 4 5 ChevronTexaco 6 ConocoPhillips 7 8 ExxonMobii 9 10 11 Shell 12 13 14 Marathon 15 16 Total 17 18 LT 7/19/04 B (Seed Money) $15,000 $22,500 $15,000 $15,000 $7,500 $0 $15,000 $15,000 $15,000 $120,000 CD Inv. # 522922 528453 522923 522924 528574 523540 Date Paid 8-Nov-00 19-Jun-01 7-Nov-00 31-0cl-00 31-Jul-01 523054 24-0cl-00 528333 15-May-01 528541 14-Aug-01 Benzene Health Research Consortium Sponsor Invoice Detail1Q05 Financial Report EF 2001 G H IJ 2002 (1 st - 2nd Otr.) K LM 2002 (3rd - 4th Otr.) N0 2003 22-Aug-01 $768,941 Inv. # Date Paid 529301 4-0cl-01 $522,627 529302 $246,314 529309 9-0cl-01 17-Sep-01 9-Jan-02 $806,441 $537,627 $268,814 Inv. # 532263 532244 532245 Date Paid 22-Feb-02 22-Feb-02 16-Jan-02 27-Aug-02 $1,344,069 $112,008 $896,046 $448,023 Inv. # 535033 535034 535035 Date Paid 11-0cl-02 2-0cl-02 5-Nov-02 26-Sep-02 23-Sep-03 $1,431,041.00 $1,028,700.00 $514,349.00 Inv. # 544951 544953 544954 $507,627 529305 $2,045,509 25-Sep-01 $1,612,882 $806,441 $806,441 $537,627 532246 532247 $5,376,273 23-Jan-02 11-Feb-02 7-Feb-02 $1,344,069 535036 13-Sep-02 $896,046 $448,023 $448,023 535037 25-Sep-02 10-Feb-03 Maralhon Ashland Maralhon Oil $5,936,307 $1,543,049.00 $771,524.50 $771,524.50 $1,028,700.00 $514,350 $514,350 $150,000 $50,000 $8,317,588.00 544956 544958 548582 548581 P Date Paid 4-Dec-03 19-Nov-03 27-0cl-03 3-0cl-03 22-Mar-04 28 Ocl 03 14 Jan 04 20-Jan-04 3-Feb-04 Q TOTAL $4,500,000 $3,000,000 $1,500,000 $4,500,000 $3,000,000 $215,000 $16,715,000 DRAFT Page 39 of41 &[DATE] SH ELL-MCCLU RG-052678 Benzene Health Research Consortium Sponsor Payment Detail 1Q05 Financial Report AB 1 10 CompanyName 2 19982 Shell Chemical 3 20086 ConocoPhillips 4 20972 ChevronTexaco 5 20239 BP International Limited 6 28285 Shell Chemical 7 28929 BP International Ltd 8 29861 ConocoPhillips 9 30179 Marathon Ashland Petroleum, LLC. 10 30853 ConocoPhillips 11 31000 Shell Chemical 12 31141 BP p.l.c. 13 31179 ChevronTexaco 14 33206 ConocoPhillips 15 34334 ExxonMobil Research and Engineering 16 34823 Shell Chemical 17 34889 ExxonMobil Research and Engineering 18 35200 ChevronTexaco 19 35207 BP p.l.c. 20 38625 ExxonMobil 21 38748 Shell Chemical 22 38779 ConocoPhillips 23 39101 BP p.l.c. 24 39214 BP p.l.c. 25 39493 ChevronTexaco 26 42934 American Petroleum Institute 27 44094 Shell Chemical 28 51153 ExxonMobil 29 51869 ConocoPhillips 30 51891 Shell Chemical 31 52332 ChevronTexaco 32 52633 BP p.l.c. 33 54618 Marathon Ashland Petroleum, LLC. 34 54472 Shell Chemical 35 55187 Marathon Oil Company 36 57362 ExxonMobil 37 560056 ChevronTexaco Energy 38 560057 ConocoPhillips 39 560058 ExxonMobil 40 560059 Shell Chemical 41 42 43 LT 7/19/04 44 RT 4/13/05 C D EF PaymentDate PaymentAmount TOTALS 10/24/2000 $ 15,000.00 10/31/2000 $ 15,000.00 11/7/2000 $ 15,000.00 yr 2000 11/8/2000 $ 15,000.00 $ 60,000.00 5/15/2001 $ 15,000.00 6/19/2001 $ 22,500.00 7/31/2001 $ 7,500.00 8/14/2001 $ 15,000.00 9/17/2001 $ 246,314.00 9/25/2001 $ 507,627.00 10/4/2001 $ 768,941.00 yr2001 10/9/2001 $ 522,627.00 $ 2,105,509.00 1/16/2002 $ 268,814.00 1/23/2002 $ 806,441.00 2/7/2002 $ 537,627.00 2/11/2002 $ 806,441.00 2/22/2002 $ 537,627.00 2/22/2002 $ 806,441.00 9/13/2002 $ 1,344,069.00 9/25/2002 $ 448,023.00 9/26/2002 $ 448,023.00 10/2/2002 $ 112,008.00 10/11/2002 $ 1,344,069.00 yr 2002 11/5/2002 $ 896,046.00 $ 8,355,629.00 1/17/2003 $ 109 1+2003 2/10/2003 $ 448,023.00 $ 448,024.09 10/3/2003 $ 771,524.50 3003 10/27/2003 $ 514,349.00 $- 10/28/2003 $ 514,350.00 11/19/2003 $ 1,028,700.00 4003 12/4/2003 $ 1,431,041.00 $ 4,259,964.50 1/20/2004 $ 150,000.00 1/13/2004 $ 514,350.00 2/3/2004 $ 50,000.00 1004 3/22/2004 $ 771,524.50 $ 1,485,874.50 $ 3/18/2005 $ 548,000.00 2/17/2005 $ 548,000.00 1005 $ $ 1,096,000.00 $ 16,715,001.09 $ 17,811,001.09 (note - does not include interest income) DRAFT Page 40 of41 &[DATE] SH ELL-MCCLU RG-052679 A 1 Company 2 American Petroleum Institute 3 BP International Limited 4 BP International Ltd 5 BP p.Lc. 6 BP p.Lc. 7 BP p.Lc. 8 BP p.Lc. 9 BP p.Lc. 10 ChevronTexaco 11 ChevronTexaco 12 ChevronTexaco 13 ChevronTexaco 14 ChevronTexaco 15 ConocoPhillips 16 ConocoPhillips 17 ConocoPhillips 18 ConocoPhillips 19 ConocoPhillips 20 ConocoPhillips 21 ConocoPhillips 22 ExxonMobil Research and Engineering 23 ExxonMobil Research and Engineering 24 ExxonMobil 25 ExxonMobil 26 ExxonMobil 27 ExxonMobil 28 Marathon Ashland Petroleum, LLC. 29 Marathon Ashland Petroleum, LLC. 30 Marathon Oil Company 31 Shell Chemical 32 Shell Chemical 33 Shell Chemical 34 Shell Chemical 35 Shell Chemical 36 Shell Chemical 37 Shell Chemical 38 Shell Chemical 39 40 LT7/19/04 41 RT 4/13/05 BC D Date Paid Amount 1117/2003 $ 1.09 (I am trying to get this $1.09 removed from the books) 1118/2000 $ 15,000.00 6/19/2001 $ 22,500.00 10/4/2001 $ 768,941.00 2/22/2002 $ 806,441.00 10/2/2002 $ 112,008.00 10/1112002 $ 1,344,069.00 BP Total 12/4/2003 $ 1,431,041.00 $ 4,500,000.00 1117/2000 $ 15,000.00 10/9/2001 $ 522,627.00 2/22/2002 $ 537,627.00 1115/2002 $ 896,046.00 ChevronTexaco Total 11119/2003 $ 1,028,700.00 $ 3,000,000.00 10/3112000 $ 15,000.00 7/3112001 $ 7,500.00 9/17/2001 $ 246,314.00 1116/2002 $ 268,814.00 9/26/2002 $ 448,023.00 10/27/2003 $ 514,349.00 ConocoPhillips Total 3/18/2005 $ 548,000.00 $ 2,048,000.00 1/23/2002 $ 806,441.00 2/1112002 $ 806,441.00 9/13/2002 $ 1,344,069.00 10/3/2003 $ 771,524.50 3/22/2004 $ 2/17/2005 $ 771,524.50 548,000.00 $ ExxonMobil Total 5,048,000.00 8/14/2001 $ 15,000.00 1/20/2004 $ 150,000.00 Marathon Ashland Total 2/3/2004 $ 50,000.00 $ 215,000.00 10/24/2000 $ 15,000.00 5/15/2001 $ 15,000.00 9/25/2001 $ 507,627.00 2/7/2002 $ 537,627.00 9/25/2002 $ 448,023.00 2/10/2003 $ 448,023.00 10/28/2003 $ 514,350.00 Shell Chemical Total 1113/2004 $ 514,350.00 $ 3,000,000.00 $ 17,811,001.09 DRAFT E SH ELL-MCCLU RG-OS2680 From: Sent: To: Cc: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Thursday, April 28, 2005 6:44 PM (GMT) Benzene OC listserve (E-mail) <BenzConsort-OC@listserve.api.org>; Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org>; Benzene consort comm (E-mail) <benzconsort-cc@listserve.api.org> mona.y.kowalczyk@exxonmobil.com FW: IF ASKED Shanghai Health Study IF ASKED about the Shanghai Health Study.doc To ALL BHRC Members: Attached is an IF ASKED statement about the Shanghai Health Study developed by Communications in response to a query from AP in Houston. We used our "main Messages" Communications Cmtte paper to derive the text. It has had review from appropriate internal API staff and also by Patsy Clegg, Shell Chemical, chairman of the Benzene Health Research Oversight Committee, Lynn Russo, ExxonMobil, Chair of the BHRC communications committee, and Mark Fitzsimmons, outside counsel for the consortium. As a reminder, if asked statements are used to talk from with reporters only. Please let me know if you have questions. Lorraine IF ASKED about the Shanghai Health Study.doc SH ELL-MCCLU RG-OS2681 IF ASKED about the Shanghai Health Study on the health effects of benzene: The Shanghai Health Study is being conducted to gain a better understanding of the relationship between benzene exposure and potential cancer risk to protect industry workers and customers. The study, begun in 2001, is currently scheduled for completion in 2007. The investigators conducting the study have full control over the study design, research, and all interpretations and conclusions that may be drawn from the data when the study is completed. Upon completion, the findings of the study will be peer-reviewed and published by the researchers in scientific journals. The Shanghai Health Study is a project of Fudan University Medical Center in Shanghai, the University of Colorado Health Sciences Center and Applied Health Sciences, an independent research firm in San Francisco. This independent study is funded by a consortium of petroleum and chemical companies, and the consortium is administered by API. The study was designed by independent epidemiological and toxicological investigators. The research protocols and the research itself are being overseen by scientific and ethics review panels composed of 14 world-renowned, independent experts in the field. The research protocols also have been approved by independent review boards at Fudan University, the University of Colorado and Applied Health Sciences. April 28, 2005 slh (F) # IF ASKED FURTHER about the actual research: Contact: Dr. Richard Irons at the University of Colorado Phone: 303-315-7196 E-mail: richard.irons@UCHSC.edu. SH ELL-MCCLU RG-OS2682 From: Sent: To: Subject: Lorraine Twerdok <Twerdokl@api.org> Thursday, April 28, 2005 12:41 PM (GMT) Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org>; Benzene OC listserve (E-mail) <BenzConsort-OC@listserve.api.org> Just received UCRSC 2005 - 2007 budget APPROVAL FYI - we are getting there! -----Original Message----From: Richard.lrons@UCHSC.edu [mailto:Richard.lrons@UCHSC.edu] Sent: Wednesday, April 27, 2005 11:06 PM To: Lorraine Twerdok Cc: Bruce Jarnot; Ann.Louden@UCHSC.edu Subject: RE: UCHSC 2005 - 2007 budget summary Dear Lorraine, We have reviewed and reconciled the details of the revised UCHSC budget and find that it is acceptable in its present form. Thank you all for your hard work on this. On another note, the BIMDS manuscript has been reformatted and is in submission. We will inform you when it is in press. Thanks again, Richard From: Lorraine Twerdok [mailto:Twerdokl@api.org] Sent: Thu 4/21/2005 9:07 AM To: Irons Richard Cc: Bruce Jarnot; Louden Ann Subject: UCHSC 2005 - 2007 budget summary UCHSC 2005 - 2007 budget summary - LT.xls Dr. lrons- Attached, for your review and approval, is a revised UCHSC budget for 2005-2007. This document has been prepared to support the grant amendment to increase the UCHSC grant UCHSC subcontractor increased costs were added into the revised cost estimate provided in the january 2005 progress report to develop the overall revised UCHSC budget. There are several worksheets included in the file: Tab 1 - Summary of cost estimates and revised payment schedule. This sheet that starts with jan 2005 costs and adds in subcontractor increases Tab 2 - Revised program budget with total costs per UCHSC and subcontractors. Please review carefully, as the january estimate did not break out subcontractor costs. Tab 3 - Program budget increases only Tab 4 - UCHSC expense detail provided with january 2005 progress report (no subcontractor increases SH ELL-MCCLU RG-OS2683 Tab 5 - EMBSI expense detail- please note addition of EA support for Yimei Zhou in 2006 Tab 6 - Fudan University Exposure Assessment cost increases. These figures were provided to API by R. Schnatter. Please contact me via return email with your comments and approval. If this budget presentation requires discussion, I am in the office and available for a phone conference over the next week. I will let you select a time/date, if required, since you are currently in Shanghai. One final question - has the manuscript on B/MD been submitted for publication yet? I have been informed that you have/will submit it to Nature. Regcwds, La VYCl LV\,e ***************************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 email: twerdokl@api.org fax: 202-682-8031 SH ELL-MCCLU RG-OS2684 From: Sent: To: Subject: Attach: Cagen, Stuart Z SCC-CF-SS <stuart.cagen@shell.com> Friday, April 8, 2005 1:02 PM (GMT) Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com> FW: BHRC-TC... New Documents for Review Irons_BIMDS_Mar2005.pdf; Thoughts on Bn EAdoc Shan: Do you have thoughts on the Irons paper Stuart Cagen Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713241 1407 Fax: 3325 Other Tel: +1 8326463987 Email: stuart.cagen@shell.com Internet: http://www.shell.com/chemicals "Business Success through HSSE Excellence" -----Original Message----From: Bruce Jarnot [mailto:jarnotb@api.org] Sent: Thursday, March 31, 2005 8:26 AM To: benzconsort-tc@listserve.api.org Subject: BHRC-TC... New Documents for Review Benzene Health Research Consortium (BHRC) Technical Committee (TC) - 1) Courtesy of Michael Bird, attached is a copy (19-page pdf) of a recent draft manuscript from Richard Irons: BenzeneInduced Myelodyplasia: New Insights from an Old Nemesis by RD. Irons, L. Lv, X. Ye, L. Bao, X.Q. Wang, J. Ryder, T.W. Armstrong, Y. Zhou, L. Miao, SA Gross and H. Fu. 2) Draft Thoughts on Benzene Exposure Assessment (3-page doc) from Gary Krieger's visit to Fudan University, 27 March 2005. Best Regards - Bruce. SH ELL-MCCLU RG-052685 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Friday, January 28,20058:19 PM (GMT) Richard Irons (E-mail) <richard.irons@uchsc.edu> benzconsort-tc@listserve.api.org; benzconsort-oc@listserve.api.org SHS Tech Committee... Follow-up to Dec 13th Denver Mtgs Irons Letter 28Jan05.doc Dear Richard - The Shanghai Health Study (SHS) Technical Committee would like to share the attached letter in response to the very successful series of meetings recently hosted by you and Dr. Krieger in Denver. .. For Jennifer Galvin, SHS Technical Committee Chair, Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-OS2686 SHANGHAI HEALTH STUDY Jennifer Galvin, Ph.D. Chair, SHS Technical Committee Phone: 918-661-3865 Email: jennifer.b.galvin@conocophillips.com CIO American Petroleum Institute 1220 L Street, NW Washington, DC 20005-4070 Email: twerdokl@api.org Date: From: To: Subject: 28 January 2005 Jennifer Galvin, PhD., for the Shanghai Health Study (SHS) Technical Committee Dr. Richard Irons 2004 Year-End Progress Report and Revised Expense Projections Dear Richard: Thanks for recently spending time with the Shanghai Health Study (SHS) Technical Committee. You and Dr. Krieger explained the current situation with the Shanghai Benzene Research program in a clear manner, particularly with regard to exposure assessment, and provided a much clearer idea of the planned path forward. It would be useful to incorporate your thoughts on implementing the revised exposure assessment plan in your 2004 year-end Progress Report. While we recognize there are still uncertainties in this plan, we would appreciate sufficient detail to allow the Technical Committee to track progress, and also allow this information to be shared through the Progress Report with the SHS expert panels. For instance, we would appreciate a written description there of the envisaged Sector group exposure analysis and its relationship to the current exposure analysis strategy. Regarding the program as a whole, the budget discussion was very informative and we would also ask you to describe this in detail in the upcoming year-end progress report. We would like you to provide detailed information on item 2) expense increases, and item 3) total expense projections by year using the categories that you currently report in your biannual progress reports (e.g., personnel, operating expenses, subcontracts, travel, equipment & indirect expenses). The "post-study analyses" costs should be included in this more detailed expense projection. We need this information for two reasons; (1) to present detailed rationale for a request for increased funding, and (2) to develop a payment schedule for the remainder of the study, should additional funds be secured. Please see the attachment to this letter, to aid you in developing this required information for the year-end report. Cc: SHS Technical Committee SHS Oversight Committee Administrative support provided by The American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 SH ELL-MCCLU RG-OS2687 Attachment 1 Item 1 - Exposure Assessment A written description of the Sector group exposure analysis and its relationship to the current exposure analysis strategy. Item 2 - Additional funding expense projections by year Please provide expense projections for the categories consistent with program progress report finance reports. If these categories should be modified (e.g. cost per case, including an explanation of which categories below it includes), please inform us. '" Personnel '" Operating Expenses '" Subcontracts '" Travel '" Equipment '" Indirect (overhead) A verbal description of the rationale for increased funding requirement for subcontractors should also be provided. Any, more detailed, expense projections for subcontractors would assist and strengthen the request for funding. Item 3 - Total expense projections by year This is essential for development of a payment schedule, should additional funds be secured. Please provide expense projections for the categories consistent with program progress report finance reports. If these categories should be modified (cost per case, including an explanation of included categories), please inform us. '" Personnel '" Operating Expenses '" Subcontracts '" Travel '" Equipment '" Indirect (overhead) Administrative support provided by The American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 SH ELL-MCCLU RG-OS2688 From: Sent: To: Cc: Subject: Cagen, Stuart Z SCC-CF-SS <stuart.cagen@shell.com> Friday, January 28,20053:35 PM (GMT) 'Lorraine Twerdok' <Twerdokl@api.org> Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com>; Clegg, Patsy M SCC-CHSE-PC <patsy. c1egg@shell.com> RE: BHRC rosters Lorraine: Along with me, for Shell, Shan Tsai should be listed as a member of the technical committee (not as an alternate) Please change Thanks Stuart Stuart Cagen Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 1407 Fax: 3325 Other Tel: +1 832 646 3987 Email: stuart.cagen@shell.com Internet: http://www.shell.com/chemicals -----Orig inal Message----From: Lorraine Twerdok [mailto:Twerdokl@api.org] Sent: Thursday, January 27, 2005 11:43 AM To: Benzene consort comm (E-mail); Benzene consort tech (E-mail); Benzene OC listserve (E-mail) Subject: BHRC rosters To BHRC committee members FYI - The attached file has all of the updated committee rosters -----Orig inal Message----From: Robin Tillery Sent: Thursday, January 27, 2005 12:38 PM To: Lorraine Twerdok Subject: benzene BenzeneCommittees. pdf SH ELL-MCCLU RG-052689 From: Sent: To: Subject: Bruce Jarnot <jarnotb@api.org> Wednesday, December 10, 20038:19 PM (GMT) BenzConsort-OC@listserve.api.org; BenzConsort-TC@listserve.api.org; BenzConsortCC@listserve.api.org Shanghai inaugural ceremony a great success! Patrick called earlier today to relate that the Shanghai Lab Inaugural event was a very great success, and that details will follow when he and Don return stateside ... Best Regards - Bruce. SH ELL-MCCLU RG-OS2690 From: Sent: To: Cc: Subject: Johnston, Michael D. <MIKE.D.Johnston@conocophillips.com> Monday, November 24,20034:08 PM (GMT) Bruce Jarnot <jarnotb@api.org>; benzconsort-oc@listserve.api.org benzconsort-tc@listserve.api.org; myron. c.harrison@exxonmobil.com; lynn.b.russo@exxonmobil.com; mfitzsimmons@steptoe.com; Matt Todd <ToddM@api.org> RE: BHRC-OC... Path Forward Re: ERP Vacancy Sounds like the right approach to me. Thanks, Bruce. Mike Johnston Phone: 281-293-4468 Mobile: 281-435-7182 Fax: 208-441-5451 Email: Mike.d.Johnston@ConocoPhillips.com -----Original Message----- From: Bruce Jarnot [mailto:jarnotb@api.org] Sent: Monday, November 24, 2003 9:50 AM To: benzconsort-oc@listserve.api.org Cc: benzconsort-tc@listserve.api.org; myron.c.harrison@exxonmobil.com; Iynn.b.russo@exxonmobil.com; mfitzsimmons@steptoe.com; Matt Todd Subject: BHRC-OC... Path Forward Re: ERP Vacancy Importance: High Benzene Health Research Consortium (BHRC) Oversight Committee - There appears to be general consensus within the Oversight Committee on a path forward regarding the ERP, following Baruch Brody's resignation: 1) The ERP shall remain an independent and autonomous entity within the Shanghai Health Study; 2) A US-based ethicist should be identified and recruited to fill Baruch's vacancy. Please advise if you have an alternate proposal or take exception to this plan; otherwise, this will be understood to be "adopted" by the Oversight Committee without need for a conference call. Action Item - API will quickly assemble a list of candidate US-based ethicists for consideration by the Oversight Committee. I will begin by asking Dr. Brody and others for potential candidate names; for each, I will attempt to provide a brief biographical sketch from internet resources. As a start, please forward any names of candidate ethicists that might come to mind ... thank you! Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SHELL-MCCLURG-052691 From: Sent: To: Cc: Subject: myron. c.harrison@exxonmobil.com Friday, November 21,2003 9:09 PM (GMT) Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; brian.e.doll@exxonmobi1.com; Burnett, Don <burnetdm@bp.com at burnetdm@bp.com>; Bruce Jarnot <jarnotb@api.org>; lynn.b.russo@exxonmobi1.com; mfitzsimmons@steptoe.com; michael.j ohnston@conocophillips.com; Beatty, Patrick (PatrickBeatty) <PatrickBeatty@chevrontexaco.com>; toddm@api.org RE: BHRC-TC... Recommendation to Combine SRP & ERP External Panel s Patty is right in my opinion .. One of the great strengths of our endeavor is the independent ethics review -- initial and ongoing. Myron C. Harrison, M.D., M.P.H. Senior Health Advisor, SH&E Exxon Mobil Corporation 5959 Las Colinas Boulevard Irving, TX, 75039-2298 phone: 972.444.1673 fax: 1633 myron.c.harrison@exxonmobil.com "Clegg, Patsy M SCC-CHSE-PC" To: "Beatty, Patrick (PatrickBeatty)" <patsy.clegg@shell.co <PatrickBeatty@chevrontexaco.com>, <mfitzsimmons@steptoe.com>, m> <Iynn.b.russo@exxonmobil.com>, "Bruce Jarnot" <jarnotb@api.org>, <benzconsort-oc@listserve.api.org>, <benzconsort-tc@listserve.api.org>, <toddm@api.org>, <brian.e.doll@exxonmobil.com>, 11/2010303:21 PM <myron.c.harrison@exxonmobil.com>, "Burnett, Don" <IMCEACCMAILburnetdm+40bp+2Ecom+20+20at+20burnetdm+40bp+2Ecom+20@SHELL.co m>, <michael.johnston@conocophillips.com> cc: Subject: RE: BHRC-TC ... Recommendation to Combine SRP & ERP External Panel s I definitely support keeping the SRP and ERP as separate organizations. I believe that we would definitely create a conflict of interest by merging them. There serve 2 very distinct functions. As far as resolution, I would vote for a quick resolution - either ballot or conference call. There is a sense of urgency about finding a chair seems to me that one of the existing members would be appropriate - and then finding an additional new US member. We have 3 protocol changes proposed. The ethics review is as critical as SRP and IRB. You may consider this email my vote for a separate SRP and ERP. Regards, Patsy Patsy Clegg Product Steward Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 SH ELL-MCCLU RG-052692 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@sheILcom Internet: http://www.sheILcom/chemicals -----Orig inal Message----From: Beatty, Patrick (PatrickBeatty) [mailto:PatrickBeatty@chevrontexaco.com] Sent: Thursday, November 20, 2003 12:27 PM To: mfitzsimmons@steptoe.com; lynn.b.russo@exxonmobiLcom; Bruce Jarnot Cc: benzcon sort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; toddm@api.org; brian.e.doll@exxonmobil.com; myron.c.harrison@exxonmobil.com Subject: RE: BHRC-TC ... Recommendation to Combine SRP & ERP External Panel s My turn to weigh in. I agree that we should stick with our original structure. I also think that rather than debate the issue via e-mails that the Oversight Committee is the appropriate forum for discussion and a final decision. To that end I would like to request that the Oversight Committee be polled as to whether they wish to address this issue quickly or wait until the next scheduled conference call in December. (Don, Patsy, Lorraine take note.) The conference call should be advertised so that others can make their opinions known. Mark should be a mandatory participant in the discussion. Also, the members of the ERP should be apprised of the situation and their input solicited. There is a pragmatic question of a chairman for the Panel that will need to be addressed if we continue with the present structure. Patrick -----Orig inal Message----From: mfitzsimmons@steptoe.com [mailto:mfitzsimmons@steptoe.com] Sent: Thursday, November 20, 2003 8: 13 AM To: 'lynn.b.russo@exxonmobiLcom'; Bruce Jarnot Cc: benzcon sort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; toddm@api.org; brian.e.doll@exxonmobil.com; myron.c.harrison@exxonmobil.com Subject: RE: BHRC-TC ... Recommendation to Combine SRP & ERP External Panel s I tend to agree with Lynn. Like it or not there are going to be people out there who will want to misinterpret and criticize the study regardless, and I think it is important that "the integrity" of the effort be maintained. Perhaps Dr. Brody and or others would have thoughts on a replacement. -----Orig inal Message----From: lynn.b.russo@exxonmobiLcom [ mailto:lynn.b.russo@exxonmobil.com] Sent: Thursday, November 20,2003 11 :05 AM To: Bruce Jarnot Cc: benzcon sort-oc@listserve.api.org; SH ELL-MCCLU RG-052693 benzconsort-tc@listserve.api.org; toddm@api.org; brian.e.doll@exxonmobil.com; myron.c.harrison@exxonmobil.com Subject: Re: BHRC-TC ... Recommendation to Combine SRP & ERP External Panels Bruce, While I'm not on the Technical Committee I receive their emails as the Communications Committee Chair. And from that perspective I strongly disagree with the proposal to combine the panels. I don't take exception to them meeting/working together, but feel quite strongly that we need to demonstrate a separate, independent ethics review capability. I would also prefer identifying a replacement for Baruch so we have 3 ethicists to consult. The ERP was established to ensure independent ethics advice on the protocols and now on any suggested revisions/changes. For that purpose, we do need a separately constituted group. We do not want it to appear that the ethics advice is weighed with input from the science advisors to come to a recommendation. The structure we have now which gives equal weight/voice to the ERP and SRP makes a very strong and good impression on external folks. I would also like to see Baruch replaced since the original concept was to include Europe, China and the US to reflect any different approaches reflected in their differenct cultural norms. That said, the way the SRP and ERP worked at Asilomar is fine. For a routine annual review that has not raised any ethics issue that worked well. But we do need to preserve the option for an ERP review, as spelled out in the original agreement on the consortium structure. Lynn Lynn B. Russo ExxonMobil Downstream Public Affairs Phone: 703-846-2500 Fax: 703-846-4169 Email: Iynn.b.russo@exxonmobil.com "Bruce Jarnot" <jarnotb@api.org> To: <benzconsort-tc@listserve.api.org> cc: <benzconsort-oc@listserve.api.org> Subject: BHRC-TC ... Recommendation to Combine SRP & ERP External Panels 11/20/03 09:43 AM Benzene Health Research Consortium (BHRC) Technical Committee Baruch Brody today resigned from the Shanghai Health Study, stating "i have been very ill and have developed esrd [end-stage renal disease] and that precludes extensive out of town work. good luck on the remainder of the project - bab". Now that the work load on both eth ics and scientific review SH ELL-MCCLU RG-052694 panels has moderated, I would like to recommend that these external panels be integrated under the leadership of Jerry Rice. Both groups worked extremely well together in this fashion at the August Asilomar meeting, and "topic lead" can still be deferred to members having that specific expertise as currently done with issues regarding biostatistics, molecular markers, industrial hygiene and other specialties within the science review panel. If so desired by the Consortium as a reasonable solution to Baruch's resignation, Jerry Rice has agreed serve in this combined capacity (suspecting there might have been a chronic debilitating health issue with Baruch, I tested this possibility with Jerry in late October). Best Regards - Bruce. ***** Bruce M. Jarnot, Ph.D., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-052695 From: Sent: To: Subject: Johnston, Michael D. <MIKE.D.Johnston@conocophillips.com> Thursday, November 20,2003 10:47 PM (GMT) Bruce Jarnot <jarnotb@api.org>; benzconsort-tc@listserve.api.org; benzconsortoc@listserve.api.org RE: BHRC-OC & -TC... copy of "regrets" note sent to Baruch I support remaining with the original structure. I fully support the ERP and SRP meeting and working together to share learnings, developing a shared understanding, and to leverage knowledge and information as appropriate. I think we need the separate, independent ethics review capability provided by the original structure. It was conceived to allow for equal weight/voice for the ERP and SRP with the background that this approach would be most favorably viewed by external communities of interest. This will require identification of a replacement for Baruch so we have 3 ethicists on the panel. I also think that the Oversight Committee is the appropriate forum for discussion and a final decision, but don't think it has to wait until mid-Dec. for a vote. I vote keeping them separate. Mike Johnston Phone: 281-293-4468 Mobile: 281-435-7182 Fax: 208-441-5451 Email: Mike.d.Johnston@ConocoPhillips.com -----Original Message----- From: Bruce Jarnot [mailto:jarnotb@api.org] Sent: Thursday, November 20, 2003 9:21 AM To: benzconsort-tc@listserve.api.org; benzconsort-oc@listserve.api.org Subject: FYI: BHRC-OC & -TC... copy of "regrets" note sent to Baruch Importance: Low Benzene Health Research Consortium (BHRC) Technical and Oversight Committees - FYI, attached is a copy of my note to Baruch Brody in response to his resignation, sent earlier this morning ... Regards - Bruce. -----Original Message----- From: Bruce Jarnot Sent: Thursday, November 20, 2003 9: 15 AM To: 'Baruch Brody' Cc: Lorraine Twerdok; Paula Podhasky; Matt Todd; Jerry Rice (E-mail) Subject: RE: Resignation from the Shanghai Ethics Review Panel Dear Baruch - It is indeed regretful that you must resign from the Ethics Review Panel, as your leadership and contributions to the Shanghai Health Study will be truly missed ... I am, however, grateful that you lead and actively participated in the most active phase of ethics review at the frontend of this study. Now that the work load on both ethics and scientific review panels has moderated, I would like to recommend that these external panels be integrated under the leadership of Jerry Rice. Both groups worked extremely well together in this fashion at the August Asilomar meeting, and "topic lead" can be deferred to SH ELL-MCCLU RG-OS2696 members having that specific expertise - as currently done with issues regarding biostatistics, molecular markers, industrial hygiene and other specialties within the science review panel. With best wishes for your well being, and with best regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org -----Original Message----From: Baruch Brody [mailto:bbrody@bcm.tmc.edu] Sent: Wednesday, November 19, 2003 10:14 PM To: Bruce Jarnot Subject: Re: Shanghai Health Study - Annual Meeting ... 17-20 August 2004 i regret to have to inform you that i must resign from this project. i have been very ill and have developed esrd and that precludes extensive out of town work. good luck on the remainder of the project bab At 04:00 PM 1111812003 -0500, you wrote: Shanghai Health Study (SHS) Investigators & Scientific/Ethics Review Panels (SRP & ERP) - Please mark your calendars --17-20 August, 2004 -- SHS Annual Conference Responding to an overwhelmingly favorable response from attendees this past August, the Benzene Health Research Consortium (BHRC) has again reserved the Asilomar Conference Center in Monterey, California for our 2004 annual conference. This email "early alert" confirms only meeting dates and location ... an itinerary and meeting agenda are not yet available, and formal invitation letters will be sent in due course. Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org Baruch Brody, Ph.D. Leon Jaworski Professor of Biomedical Ethics Distinguished Service Professor Baylor College of Medicine Andrew Mellon Professor of Humanities Department of Philosophy Rice University SH ELL-MCCLU RG-OS2697 713-798-3503 (phone) 713-798-5678 (fax) bbrody@bcm.tmc.edu SH ELL-MCCLU RG-OS2698 From: Sent: To: Subject: Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> Thursday, November 20,2003 9:21 PM (GMT) Beatty, Patrick (PatrickBeatty) <PatrickBeatty@chevrontexaco.com>; mfitzsimmons@steptoe.com; lynn.b.russo@exxonmobil.com; Bruce Jarnot <jarnotb@api.org>; benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; toddm@api.org; brian.e.doll@exxonmobil.com; myron.c.harrison@exxonmobil.com; Burnett, Don <burnetdm@bp.com at burnetdm@bp.com>; michael.j ohnston@conocophillips.com RE: BHRC-TC... Recommendation to Combine SRP & ERP External Panel s I definitely support keeping the SRP and ERP as separate organizations. I believe that we would definitely create a conflict of interest by merging them. There serve 2 very distinct functions. As far as resolution, I would vote for a quick resolution - either ballot or conference call. There is a sense of urgency about finding a chair - seems to me that one of the existing members would be appropriate - and then finding an additional new US member. We have 3 protocol changes proposed. The ethics review is as critical as SRP and IRS. You may consider this email my vote for a separate SRP and ERP. ~garcfs) Patsy Patsy Clegg Product Steward Shell Chemical 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: Beatty, Patrick (PatrickBeatty) [mailto:PatrickBeatty@chevrontexaco.com] Sent: Thursday, November 20, 2003 12:27 PM To: mfitzsimmons@steptoe.com; Iynn.b.russo@exxonmobil.com; Bruce Jarnot Cc: benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; toddm@api.org; brian.e.doll@exxonmobil.com; myron.c.harrison@exxonmobil.com Subject: RE: BHRC-TC... Recommendation to Combine SRP & ERP External Panel s My turn to weigh in. I agree that we should stick with our original structure. I also think that rather than debate the issue via e-mails that the Oversight Committee is the appropriate forum for discussion and a final decision. To that end I would like to request that the Oversight Committee be polled as to whether they wish to address this issue quickly or wait until the next scheduled conference call in December. (Don, Patsy, Lorraine take note.) The conference call should be advertised so that others can make their opinions known. Mark should be a mandatory participant in the discussion. Also, the members of the ERP should be apprised of the situation and their input solicited. There is a pragmatic question of a chairman for the Panel that will need to be addressed if we continue with the present structure. Patrick -----Original Message----From: mfitzsimmons@steptoe.com [mailto:mfitzsimmons@steptoe.com] SH ELL-MCCLU RG-OS2699 Sent: Thursday, November 20, 2003 8: 13 AM To: 'Iynn.b.russo@exxonmobil.com'; Bruce Jarnot Cc: benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; toddm@api.org; brian.e.doll@exxonmobil.com; myron.c.harrison@exxonmobil.com Subject: RE: BHRC-TC... Recommendation to Combine SRP & ERP External Panel s I tend to agree with Lynn. Like it or not there are going to be people out there who will want to misinterpret and criticize the study regardless, and I think it is important that "the integrity" of the effort be maintained. Perhaps Dr. Brody and or others would have thoughts on a replacement. -----Original Message----From: lynn.b.russo@exxonmobil.com [mailto:lynn.b.russo@exxonmobil.com] Sent: Thursday, November 20, 2003 11 :05 AM To: Bruce Jarnot Cc: benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; toddm@api.org; brian.e.doll@exxonmobil.com; myron.c.harrison@exxonmobil.com Subject: Re: BHRC-TC ... Recommendation to Combine SRP & ERP External Panels Bruce, While I'm not on the Technical Committee I receive their emails as the Communications Committee Chair. And from that perspective I strongly disagree with the proposal to combine the panels. I don't take exception to them meeting/working together, but feel quite strongly that we need to demonstrate a separate, independent ethics review capability. I would also prefer identifying a replacement for Baruch so we have 3 ethicists to consult. The ERP was established to ensure independent ethics advice on the protocols and now on any suggested revisions/changes. For that purpose, we do need a separately constituted group. We do not want it to appear that the ethics advice is weighed with input from the science advisors to come to a recommendation. The structure we have now which gives equal weight/voice to the ERP and SRP makes a very strong and good impression on external folks. would also like to see Baruch replaced since the original concept was to include Europe, China and the US to reflect any different approaches reflected in their differenct cultural norms. That said, the way the SRP and ERP worked at Asilomar is fine. For a routine annual review that has not raised any ethics issue that worked well. But we do need to preserve the option for an ERP review, as spelled out in the original agreement on the consortium structure. Lynn Lynn B. Russo ExxonMobil Downstream Public Affairs Phone: 703-846-2500 Fax: 703-846-4169 Email: lynn.b.russo@exxonmobil.com "Bruce Jarnot" <j arnotb@api.org> To: <benzconsort-tc@listserve.api.org> SH ELL-MCCLU RG-OS2700 cc: <benzconsort-oc@listserve.api.org> Subject: BHRC-TC ... Recommendation to Combine SRP & ERP External Panels 11120/03 09:43 AM Benzene Health Research Consortium (BHRC) Technical Committee Baruch Brody today resigned from the Shanghai Health Study, stating "i have been very ill and have developed esrd [end-stage renal disease] and that precludes extensive out of town work. good luck on the remainder of the projectbab". Now that the work load on both ethics and scientific review panels has moderated, I would like to recommend that these external panels be integrated under the leadership of Jerry Rice. Both groups worked extremely well together in this fashion at the August Asilomar meeting, and "topic lead" can still be deferred to members having that specific expertise - as currently done with issues regarding biostatistics, molecular markers, industrial hygiene and other specialties within the science review panel. If so desired by the Consortium as a reasonable solution to Baruch's resignation, Jerry Rice has agreed serve in this combined capacity (suspecting there might have been a chronic debilitating health issue with Baruch, I tested this possibility with Jerry in late October). Best Regards - Bruce. ***** Bruce M. Jarnot, Ph.D., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SHELL-MCCLURG-052701 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Friday, October 31,2003 7: 14 PM (GMT) BenzConsort-TC@listserve.api.org Matt Todd <ToddM@api.org> Shanghai Technical Committee: Conf Call ... Fri Nov 07, 2:00pm EST Minutes BHRC-TC API 1029 2003.doc Who: Benzene Health Research Consortium - Technical Committee (BHRC-TC) What: BHRC-TC Conference Call When: Friday Nov 07, 2:00-3:00pm EST Where: 1-866-448-6756 (domestic - toll free) +763-315-6900 (international) participant code: 6828319# Why: Stuart and Patrick requested that the TC meet by conference call to review: 1) 3Q03 financial package (Lorraine will email separately) 2) proposal to OC ... $800K from ME Study to provide: -- $500K for contingency fund -- $300K for urinary SPMA (ME) and HIV (CC) testing Attch: draft minutes from the Oct 29 BHRC-TC meeting Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-052702 Benzene Health Research Consortium Draft Technical Committee Meeting Minutes October 31, 2003 API, Washington DC Participants 1. Patrick Beatty (ChevronTexaco) 2. Michael Bird (ExxonMobil) 3. Steve Bose (ExxonMobil) 4. Bill Broddle (ConocoPhillips) 5. Stuart Cagen (Shell) 6. Patsy Clegg (Shell) 7. Bruce Jarnot (API) 8. Lorraine Twerdok (API) General Items Antitrust review and introductions were completed Shanghai-based "administrative manager" or "deputy director" for Richard Irons was discussed, as a means of reducing Consortium risk Otto Wong's request to reallocate travel funds, within AHS approved budget, was approved o ~~~iggttE13tyq~: communicate approval to Otto (completed 10/30103) I.G~,grnttB~~tigl$1gtYr-ttE13tY~: resume monthly "progress checks" with Pis Contingency Fund Stuart proposed adding a $500K "contingency fund" line item to the budget Discussion supported both inclusion of a contingency fund, and the proposed size of the fund Endorsement of SRP Recommendations Two research enhancements proposed by the SRP were scientifically endorsed: o Addition of urinary SPMA analyses in ME study (link to earlier studies) o Addition of HIV testing of controls in CC study (a risk factor for NHL) Funding proposed by reducing # of ME workers from 2000 to 1000 o Michael reported possible funding interest by a EU biomarkers group; will consider at April 2004 meeting DRAFT Rev 8120103 Page 10f4 SH ELL-MCCLU RG-052703 Benzene Health Research Consortium Draft Technical Committee Meeting Minutes Overall Budget Reconcilliation Investigator feedback suggested ME study could best withstand a "cut" in research budget; CC & DP studies should not be reduced Stuart recommended that an $800K reduction in ME budget be proposed o $500K toward contingency fund o $300K to fund added HIV testing (CC) & SPMA analyses (ME) o ,I,tH?O ... 8?triQk to review proposal wI Dr. Irons before next OC meeting o Proposal then goes to OC & SRP for review, endorsement Outreach to GOs & NGOs Stuart & Patrick suggested that the Consortium begin working "outreach" to both governmental (GOs) and non-governmental organizations (NGOs), such as the EPA and Leukemia Society Short term goal: active GO & NGO participation on the Technical Committee o EPA's Bob Sonowanee (sp?) had indicated desire to participate Longer term goal: possible GO & NGO financial support for the study A meeting at API was suggested to introduce GOs/NGOs to the study, scheduled about -6 months before the 2004 annual meeting (February?) Financial Operations API's CFO, Brenda Hargett, provided an overview of API financial operations, accounting practices and systems Recent development of system output, tailored to feed into the Consortium quarterly financial package, was highlighted Brenda indicated that API could contract an independent accounting review (or audit) of the University of Colorado grant, if desired o Cost estimated between $5-$25K, depending on scope and output DRAFT Rev 8120103 Page 20f4 SH ELL-MCCLU RG-052704 Benzene Health Research Consortium Draft Technical Committee Meeting Minutes 3Q03 Financial Package Lorraine reviewed the format and content of the newly-developed quarterly financial report package, including rationale for budget projections ~q~iQnt-t..Qrr~iQ~ to recap Brenda's "API Financial Ops" presentation, and "Otrly Financial Report" format & content review at Nov 10/11 BHRC-OC mtg ~q~iQnl~~m$ were identified and requested to upgrade the report: o ~~~ new sheet detailing "UCHSC Subcontracts" for 4003 o ~~~ "comment flags" to identify source of data (e.g., budget values) o Rbjrjg~ cash flow statement to "actual" API expenses o ~~g line item for "Contingency Fund", when authorized o ItQQtOQt~ USHSC and T&E pages, indicating that "actual expenses" are from Progress Reports, and do not reflect grant payments o ,i~g "disbursement" or "grant payment" rows to Summary page o Move "Cash Flow Statement" to front section of book o P~'e~~ "names" column from Sponsor Payments sheet o $I"lrio~ width of columns to compress size of spreadsheets o ~r'mt 2-sided, on legal size paper Next Meeting A conference call was scheduled for Friday, Nov ih at 2:00pm EST DRAFT Rev 8120103 Page 30f4 SH ELL-MCCLU RG-052705 Benzene Health Research Consortium Draft Technical Committee Meeting Minutes DRAFT Rev 8120103 Page 40f4 SH ELL-MCCLU RG-052706 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Tuesday, October 21, 2003 4: 11 PM (GMT) benzconsort-oc@listserve.api.org benzconsort-tc@listserve.api.org BHRC-OC... Shanghai contracts for review APCO Amendment.pdf; APCO Contract.pdf; AHS Contract.pdf; Albertini SRP Contract.pdf; Irons T&E Contract.pdf; UCRSC Grant.pdf Benzene Health Research Consortium - Oversight Committee (BHRC-OC) For those attending the Oct 28 Contract Review, attached are pdf copies of several contracts (with any modifications) for your preview: AHS - Contract, Addendum & Extension Albertini - Contract & Extension (a sample SRP/ERP contract) APCO - Contract & Addendum (2 files) Irons T&E - Contract & Extension UCHSC - Grant & Addendum The Communication committee plans to review the APCO contract during their Thursday conference call, and the completed APCO contract review form will be circulated once it's available. Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-052707 American Petroleum Institute 1220 LStreet, h ...lwest Washington, DC 20005-4070 202-682-8100 Red Cavaney President and CEO Dr. Richard Irons Health Sciences Center University of Colorado Campus Box C238 4200 East Ninth Avenue Denver, CO 80262 Dear Dr. Irons: API Reference No. 01-0000-4788 The American Petroleum Institute ("API"), as the representative for the Benzene Health Research Consortium, is pleased to provide a Grant totaling $13,665,017.00 to fund the University of Colorado Health Sciences Center's ("UCHSC") five-year research study of Iymphohematopoietic health risks from occupational exposure to benzene in the Peoples Republic of China. This Grant is being provided to accomplish the research as set forth in the most recent versions of the "Research Protocol and Criteria Document established by the investigators and approved by the review panels as specified in paragraph iv below and the budget approved by the Benzene Health Research 'Consortium for this program. 1. Grant monies will be disbursed to UCHSC according to the following schedule: 30% in Year One (payable in two installments) 25% in Year Two 15% in Year Three 15% in Year Four 15% in Year Five subject to the following conditions: i. UCHSC acknowledges that the research study will be conducted consistent with the research proposal and budget developed by the Principal Investigator and the Benzene Health Research Consortium. ii. UCHSC will establish cooperative agreements with Fudan University in Shanghai, China; the Shanghai Municipal Center for Disease Control and Prevention; the Shanghai Municipal Institute for Public Health Supervision; and Exxon Mobil Biomedical Sciences in Annandale, N.J. (collectively known as "cooperative entities") to assist in performance of the research study. SHELL-MCCLURG-052708 University of Colorado API Reference No. 01-0000-4788 Page 2 iii. It is recognized that payments made by UCHSC to the cooperative entities will be of a pass through nature and that UCHSC will not be responsible for the management of such contracts. It is also recognized that the agreements with Fudan University in Shanghai, the Shanghai Municipal Center for Disease Control and Prevention, and the Shanghai Municipal Institute for Public Health Supervision will not involve cost accounting of funds transferred as part of this Grant given the nature of those institutions and the reporting otherwise provided by the Principal Investigator pursuant to the research proposal and budget iv. UCHSC acknowledgles that the protocols and conduct of the research during the life of the Grant are subject to annual review and approval by an independent scientific review panel as well as by an ethics review panel, both of which will be established by API. These panels shall be notified immediately when a change in protocol is proposed. No significant changes in protocol that would effect the scope of work will be exercised without approval by both the scientific review panel and ethics review panel. v. API, or an agent or nepresentative of API, will have access to, and may periodically review, the record of funds disbursed by UCHSC as part of the research study, including disbursements by UCHSC to the cooperative entities. vi. Dr. Richard Irons, tho Principal Investigator, will have budget authority to reallocate funds between and among different budget categories and may authorize the transfer of funds to the cooperative entities identified in this agreement, provided the Grant monies disbursed to UCHCS are used and expended consistent with the research program and operating budget proposed by, and as may necessarily be modified by, API. vii. Dr. Richard Irons will provide satisfactory biannual reports of all expenditures, as provided by the research proposal and budget. Biannual reports are due January and July of Elach calendar year. Continuance of funding is contingent on API approval of these biannual reports. viii. The research study and expenditure of the Grant monies are in compliance with all applicable laws, both foreign and domestic, including the United States Foreign Corrupt Practices Act. 2. This Grant shall be effective upon signature of Grantee below and shall terminate on December 31 , 2006. 3. API, however, reserves the right to terminate this Grant by giving thirty (30) days notice of such termination t0' llCHSC. Upon receipt of such notice of termination, UCHSC shall cease incurring costs on this project, except with the prior approval of SHELL-MCCLURG-052709 University of Colorado API Reference No. 01-0000-4788 Page 3 API for such costs on this project, which are necessary to close out the project. In the event of such termination, API's sale obligation will be to reimburse UCHSC for actual costs incurred as of the date of termination and such subsequent costs incurred with prior approval of API. In no event shall such payment include costs and/or anticipated fees for unperformed work or exceed the maximum amount of the annual Grant disbursement for the year in which the Grant is terminated. 4. It is understood that if any ()f the funds provided under this Grant are not used for this project by the termination date, Grantee shall return such unused funds to API. If the terms of the Grant agreement are acceptable, please sign both copies and return one to API. UNIVERSITY OF COLORADO 8y: __________________ AMERICAN PETROLEUM I TITUTE Date:_ _ _ _ _ _ _ _ _ _ _ __ By: AwJ.iMJ~ G. William Frick Vice President, General Counsel & Secretary Date: 10 tel{ b I SHELL-MCCLURG-OS2710 American Petroleum Institute 1220 LStreet, Northw( Washington, DC 2OOO~0 Tel 202-682-8340 Fax 202~2~70 E-mail feldman@apLorg Howard Feldman Director Research Analysis and Scientific Affairs October 16, 2001 Dr. Richard Irons Health Sciences Center University of Colorado Campus Box C238 4200 East Ninth Avenue Denver, CO 80262 API Reference No. 01-0000-4788 Amendment No.1 01-0000-4804 Dear Dr. Irons: The October 2,2001 grant agreement between the American Petroleum Institute ("API"), as the representative for the Benzene Health Research Consortium, and the University of Colorado Health Sciences Center (UCHSC), for a five-year research study of Iymphohematopoietic health risks from occupational exposure to benzene in the Peoples Republic of China, is amended as follows: 1. Paragraph 1(ii) is amended to include the Children's Hospital Medical Center of Cincinnati as a cooperative entity. 2. Paragraph 1(vii) is amended by replacing the current paragraph with the following text: Dr. Richard Irons will provide biannual progress reports as provided by the research proposal. UCHSC will prepare and provicle biannual financial reports of expenditures made by UCHSC. Biannual reports are due January and July of each calendar year. Continuance of funding is contingent upon API approval of these biannual reports. 3. Paragraph 3 is amended by replacing the current paragraph with the following text: API, however, reserves the right to terminate this Grant by giving thirty (30) days notice of such termination to UCHSC. Upon receipt of such notice of termination, UCHSC shall cease incurring costs on this project, except with the prior approval of API, which shall not be unreasonably withheld, for such costs that am necessary to close out the project. In the event of such termination, API's sole obligation will be to reimburse UCHSC for actual costs incurred, including UCHSC's legal commitments to third parties for activities under this grant agreement, as of the date of termination, and subsequent costs incurred with prior approval of API. However, API shall not be responsible for third -party obligations that UCHSC incurs more than one year following termination of this Grant agreement. Furthermore, UCHSC agrees to use its best efforts to minimize the duration of its third-party obligations under this agreement. In no event shall such payment include costs and/or anticipated fees for unperformed work or exceed the maximum amount of the annual Grant disbursement for the year in which the Grant is terminated. In all other respects, the terms and conditions of the October 2,2001 grant agreement shall remain in full force and effect. An equal opportunity employer SHELL-MCCLURG-OS2711 University of Colorado _" Reference No. 01-0000-4788 Page 2 If the foregoing is acceptable, please sign below and return one copy of this letter to API. UNIVERSITY OF COLORADO AMERICAN PETROLEUM INSTITUTE I( Date Howard J. F dman Regulatory nalysis & Scientific Affairs Director srenbiettSAAcy Chief Financial Officer Date SHELL-MCCLURG-OS2712 American Petroleum Institute 1220 LStre.,.. ,Morthwest Washington, DC 20005-4070 (202) 682-8240 Fax (202) 682-8029 E-mail frick@apLorg G. William Frick Vice President, General Counsel & Secretary Dr. Richard Irons 4800 Baseline Road #E104-253 Boulder, Colorado 80303 Contract No. 2002-100092 Dear Dr. Irons: This letter of agreement between the American Petroleum Institute (API) and Dr. Richard Irons (Contractor) authorizes Contractor to continue efforts on a multi-year study of benzene-exposed workers in China. Specifically, the agreement allows Contractor to continue work with the Chinese collaborators on the study by supporting travel and ancillary expenses relating to the research program. The agreemEmt will also support the living expenses of American researchers, including rent of an apartment in Shanghai, China. This agreement will provide a cash advance for this effort, and shall be in accordance with Contractor's estimate of related expenses, which is attached and made a part hereof. This agreement is subject to the following terms and conditions: 1. Dr. Richard Irons shall be th~roject mana.ge.t,.. c.ontractor shall give API prior written i'lnotice of the replacement FII~~II'tln'lfG1!(M~ffe.. of the project manager. API shall have the right to approve a roduction in effort and, in the case of replacement of the project manager, API shall have the right to approve a successor. Iff)L 2. Technical and administrative aspects of this agreement will be under the direction of Howard J. Feldman, Director, Regulatory and Scientific Affairs, American Petroleum Institute, 1220 L Street, NW, Washington, D.C. 20005, or whomever he designates. The designated API representative for work conducted hereunder is George Woodall (202-6828067, email: woodallg@api.om). Contractor shall send all correspondence and reports relating to this agreement to his attention at the foregoing address. 3. API is providing a cash advance in the amount of three hundred ninety-three thousand one hundred four dollars ($393,104) for expenses for calendar year 2002, as outlined in Contractor's attached estimate. API shall disburse the cash advance in three (3) installments: (a) $178,210 for the 1sl and 2nd quarter of 2002 by March 25, 2002; (b) $81,289 by July 1, 2002; anel (c) $133,605 by October 1, 2002. On a quarterly basis, Contractor shall provide API with a detailed statement of expenses, including documentation, for costs incurred during that quarter. Such expense statements shall indicate the nature of expenditures, and shall express expenditure amounts in U.S. dollars (or have documented exchange rate and conversion). An equal opportunity employer SHELL-MCCLURG-052713 Dr. Richard Irons Contract No. 2002-100092 Page 2 Specific types of expenses have the following additional documentation requirements: For airline travel - original receipts and boarding passes. Travel expenses shall be limited to coach class accommodations for domestic travel and business class accommodations for international travel. For hotel - original receiipts. Expenses shall be limited to reasonable accommodations. For resident quarters - receipt for monthly rent payments. For monthly services (e.g., telephone, internet, utilities, etc.) - copy of contracts or monthly bills. . . . - -, - , ' c . . . c. ",. . r " .'. ,,' Other - must be detailed and any in excess of $50 require an original receipt. Contractor shall submit quartE~rly expense statements and documentation, referencing above contract number, to Ge~orge Woodall within twenty-one (21) days of the end of each calendar quarter. After reviewing the expense statement from the third calendar quarter, API will use the data from the first three (3) calendar quarters to project expenditures through the end of the calendar year, for purposes of disbursing Contractor's cash advance for the first calendar quarter of the next year. Any funds that are not projected for use by year-end will be subtracted from Contractor's 'first cash advance of the next calendar year. In reviewing Contractor's financial statement from the fourth calendar quarter, API will make any adjustments based on actual expenditures reported. 4. This agreement shall cover the period January 1, 2002 through December 31 , 2002. 5. API shall have the right at all reasonable times during the course of the study, and for a reasonable period following completion of the study, to inspect Contractor's financial records relating to the work conducted hereunder, for the purpose of insuring conformance with this agreement and with generally accepted good scientific practices, and to verify the accuracy of invoices. Such inspection shall include the right to photocopy records pertaining to work conducted hereunder, excluding individual timesheets. 6. It is agreed that API shall have the right to terminate this agreement at any time by providing a notice of such termination to Contractor. Such notice may be provided either through oral or written communication from API. Upon receipt of such notice of termination, Contractor shall cease incurring costs on this project except with the prior approval of API for such costs which are necE~ssary to close out the project. Contractor shall submit to API a final financial statement within thirty (30) days of the effective termination date. API agrees, however, to reimburse Contractortor the outstanding amounts due under the 3-year lease referenced in paragraph 3 executed by the Contractor on API's behalf. The final financial statement shall include documentation required under paragraph 3 and reimbursement for any UnSpE!nt funds. API shall not reimburse Contractor for costs that are not actually incurred or costs which exceed the maximum amount of the agreement as set forth in paragraph 3. 7. Upon termination of this agreement, Contractor shall return to API any information furnished hereunder by API, together with all documents, data or other material developed therefrom. SHELL-MCCLURG-OS2714 Dr. Richard Irons Contract No. 2002-100092 Page 3 8. It is understood that Contractor is acting as an independent contractor in its performance of any and all work hereunder. Contractor shall be solely responsible and liable for reasonable attorneys' fees incurred by API due to Contractor's performance hereunder, and the payment of all legal damages awarded to its employees or agents, or to any other person(s), on account of any property damage, personal injury, or death of any person(s) arising from, or in connection with, the performance of this agreement due to any act or omission on Contractors part. Contractor shall hold API, its members, officers and employees harmless from suc:h claims, liability or damages. 9. Contractor is responsible for c:omplying with all applicable laws, both foreign and domestic in performance of this contract. 10. Any change, modification, ext1ension, termination, or waiver of this agreement or any of its provision must be in writing and signed by both parties. 11. Contractor will not use the trademark or name of the American Petroleum Institute or any abbreviation thereof, in any publicity, advertising, or for other promotional purposes without the prior written approval of API. 12. District of Columbia law shall !;:J0vern the terms of this agreement. 13. In the event of inconsistencies between this agreement and its attachments, the express terms of this agreement shall govern. 14. Paragraphs 5-14 shall survive the termination of this agreement. If the above terms and conditions are acceptable, please sign below and return one original signed copy of this agreement to API. AMERICAN PETROLEUM INSTITUTE BY:AcJ~ I G. William Frick Vice President, General Counsel & Secretary By: --l+-a~Q~.J~:::l-~.~HCL---\~F-i1_A __ K3i-enda S. Hargett (5 Chief Financial Officer Date: ~ ~ J~Od--- SHELL-MCCLURG-052715 American Petroleum Institute 1220 LStreet, NoI'IhYm;\<,' Washington, DC 20005-4070 Tel 2OH8H34O Fax 202-682-8270 E-mail feldmanOapi.org Howard Feldman Director Regulatory Analysis &Scientiftc Affairs DEC 21" . Dr. Richard Irons 4800 Baseline Road #E104-253 Boulder, CO 80303 Contract No. 2002-100092 Date Extension and Change In API Representative Dear Dr. Irons: The above agreement between the American Petroleum Institute (API) and you, for expenses related to a multi-year study of benzene-exposed workers in China, is amended as follows: 1. The termination date is extended from December 31, 2002 to December 31, 2003. 2. The API representative for this agreement is changed to Lorraine Twerdok, Ph.D., DABT (202-682-8344; e-mail: twerdokl@api.org). All correspondence, reports and invoices related to this agreement shall be sent to her attention at the above address. In all other respects, the terms and conditions of the above agreement shall remain in full force and effect. c: Lorraine Twerdok, Ph.D., DABT James M. Vail, Ph.D. An equal opportunity ampIoyar SHELL-MCCLURG-052716 American Petroleum Institute 12: 3treet, Northwest Washington, IDC 20005-4070 2026828000 AGREEMENT (NI::>t valid for more than $25,000.00) Richard Albertini, M.D., Ph.D. Pleasant Valley Road API D~pt:.Regulatory Analysis & Scientific Affairs. Contract Number: 2002-100057 P. O. Box 168 Underhill Center, Vermont 05490 .., . ,',,', -- - This agreement, executed on the last date written below, by and between the American Petroleum Institute (hereinafter "API"), and the party named above (hereinafter "Contractor") is as follows: Scope of Work The work to be performed by Contractor under the terms and conditions of this agreement (hereinafter "work") is as follows: Contractor will serve as an independent expert on the Scientific Review Panel for the Benzene Health Effects Research Pmgram, and review and approve study protocols, as well as comment on proposed changes in the scope of the research program as described in Roles and Responsibilities of the Scientific Review Panel for the Benzene Health Effects Research Program. Contractor will travel to designated meeting places, and will partiCipate in critiquing protocols, offering suggestions to improve study deSign. Authorized Representative API's authorized representative for this agreement shall be George Woodall (202-682-8067; e-mail: woodallg@apLorg). Contractor's authorized representative shall be Richard Albertini, M. D., Ph.D. Neither party shall change authorized representatives without prior written notice to the other party. Duration The work shall commence upon Signature and shall terminate January 31, 2003. All work performed hereunder shall be completed to the satisfaction of API. Compensation and Manner of Payment (complete either A. or B.) A. Compensation to the Contractor for the work shall be a fixed price of .%.$_ _---:. -or- B. Compensation to the Contractor for the work shall be at a rate of $ 125 per hour and shall not exceed a total of $8,000 for the entire agreement. Contractor will be reimbursed for certain expenses incurred in the performance of the work. Expenses may include coach class domestic travel or business class international travel, food, lodging, telephone, and other reasonable expenses as determined by API. Contractor must provide appropriate documentation when requesting reimbursement for expenses. For the purpose of this agreement, expenses will not exceed $1,200. The total obligation to Contractor under this agreement shall not exceed (total of fees and expenses) $9.200. C. To receive payment for work performed under this agreement, the Contractor shall submit a detailed invoice to API's authorized representative as agreed above. Each invoice shall state the date; a summary of the work accomplished and hours worked during the invoice period; itemization and documentation for all reimbursablle expenses, including receipts for all reimbursable expenses over $50; and the total dollar amount requested. Payment will be made within thirty (30) days of API's receipt of the invoice. Restrictions on Publicity Contractor shall not use the trademark or name "American Petroleum Institute," or any abbreviations thereof, in any publicity, advertising, or for other promotional purposes without the prior written approval of API. This provision shall survive the termination of this agreement. An equal opportunity employer SHELL-MCCLURG-OS2717 Termination API shall have the right to terminate this agreement at any time upon written notice to Contractor. In the event of termination, API's only obligation to Contractor shall be to compensate Contractor for the services provided prior to the date of termination. Indemnification It is understood that Contractor is acting as an independent contractor in its performance of any and all work hereunder. Contractor shall be solely responsible and liable for reasonable attorneys' fees incurred by API due to Contractor's performance hen~under, and the payment of all legal damages awarded to its employees or agents, or to any other person or persons, on account of any property damage or personal injury sustained or sufferedby;ordeathofariY-peison or persons arising out of or in connection with the performance of this agreement due to any act or omission on Contractor's part in connection therewith. Contractor shall hold API, its members, officers and employees harmless from such claims, liability, or damages. ~'I'~\.,",r"\~Ar\ Ownership All reports, papers, and other documents developed hereunder, and the right to copyright such reports, papers, and other documents, shall be the property of API. API may use such materials in any manner which API, in its sole discretion, deems fit and proper, including submission to governmental agencies, use in litigation, or use in proceedings belfore governmental bodies. Financial Records and Examination API shall have the right at reasonablH times to inspect and/or copy the financial and technical records used in and relating to the work conducted hereunder, or to perform an audit in order to determine the accuracy of the invoices and technical reports submitted hereunder. API may audit all relevant records of Contractor and any such vendor or subcontractor in connection with the work and all transactions related thereto for the sole purpose of determining whether there has been compliance with this paragraph. Supporting Documents Any specifications developed either separately or jOintly by API and/or Contractor, any bid or proposal submitted by Contractor, and/or any other supporting documents deemed necessary by API to clarify this agreement, or any part thereof, shall become incorporated herein. In the event of inconsistencies between the terms of this agreement and its altachment(s), the express terms of this agreement shall govern. For purposes of this agreement and this paragraph, the following document(s) is (are) attached and made a part hereof: Roles and Responsibilities of the Scientific Review Panel for the Benzene Health Effects Research Program. Governing Law The laws of the District of Columbia shall govern this agreement. Entire Agreement This agreement and the supporting documents designated herein above represent the entire agreement of the parties. This agreement may not be changed except by written agreement of the parties. RICHARD ALBERTINI, M.D., PH.D. Howard J. F (jman Regulatory nalysis & Scientific Affairs Director Date Brenda S. Hargett Chief Financial Officer Date SHELL-MCCLURG-052718 American Petroleum Institute 1220 LStreet, NorthYt"-J. Washington, DC 20005-4070 Tel 202068H340 Fax 202-682-8270 E-mail feklmanOapi.org Howard Feldman Director ~atory Analysis &Scientific Affairs DEC 2.Z" Richard Albertini, M.D., Ph.D. Pleasant Valley Road P. O. Box 168 Underhill Center, Vermont 05490 Contract No. 2002-1000057 Date Extension and Change In API Representative Dear Dr. Albertini: The above agreement between the American Petroleum Institute (API) and you, for work related to a multi-year study of benzene-exposed workers in China, is amended as follows: 1. The termination date is extended from December 31, 2002 to December 31, 2004. 2. The API representative for this agreement is changed to Lorraine Twerdok, Ph.D., DABT (202-682-8344; e-mail: twerdokIOapi.org). All correspondence, reports and invoices related to this agreement shall be sent to her attention at the above address. In all other respects, the terms and conditions of the above agreement shall remain in full force and effect. c: Lorraine Twerdok, Ph.D., DABT James M. Vail, Ph.D. An aqual opporU1iIy employer SHELL-MCCLURG-052719 American Petroleum Institute 1220 l St~. ;orthwest Washington, DC 20005-4070 (202) 682-8240 Fax (202) 682-8029 E-mail frick@api.org G. William Frick Vice President, General Counsel &Secretary Otto Wong, Sc.D. Applied Health Sciences 181 Second Avenue, Suite 628 P. O. Box 2078 San Mateo, CA 94401 Contract No. 2002-100093 Dear Dr. Wong: This letter of agreement between the American Petroleum Institute (API) and Applied Health Sciences (AHS) authorizes AHS to continue work under a five-year program in collaboration with Fudan University (Dr. Fu Hua) to conduct case-control studies of acute myeloid leukemia and non-Hodgkin'S lymphoma from o(~upational exposure to benzene in the Peoples Republic of China (outlined in the attached Table 1, which is made a part hereof). This agreement shall fund activities for calendar year 2002 (representing year 1, quarters 2-4, and year 2, quarter 1 of the five-year program). This agreement is subject to the following terms and conditions: 1. AHS agrees that the project manager for this agreement shall be Dr. Otto Wong. AHS shall give API prior written notice of the replacement or reduction in the level of effort of the project manager. API shall have the right to approve a reduction in effort and, in the case of replacement of the project manager, API shall have the right to approve a successor. 2. Technical and administrative aspects of this agreement will be under the direction of Howard J. Feldman, Regulatory Analysis & Scientific Affairs Director, American Petroleum Institute, 1220 L Street, NW, Washington, D.C. 20005, or whomever he designates. The designated API representative for work conducted hereunder is George Woodall (202-6828067; e-mail: woodallg@api.org). AHS shall send all correspondence and reports relating to this agreement to his attention at the foregoing address. 3. AHS agrees to perform the work for calendar year 2002 for an amount not to exceed four hundred thirty-five thousand five hundred fourteen dollars ($435,514). This represents the relevant portions of the year 2002 budget as detailed in Tables 2,3,4 and 5, which are attached and made a part hlneof. AHS shall invoice API on a monthly basis for work completed under this agreement. API shall pay invoices within thirty (30) days of API's receipt. Said invoices must reference the above contract number and shall be submitted to George Woodall. Reimbursement of travel expenses shall be limited to coach class for domestic travel or business class for international travel and reasonable accommodations associated with the conduct of this project. An original receipt or copy thereof must support claims for reimbursement of expenses of fifty dollars ($50.00) or more. API may withhold up to fifteen percent (15%) of the agreement amount, pending API's acceptance of all work products and programs as specified in the milestone table in paragraph 5. 4. This agreement shall cover work authorized by API prior to signature below, and shall terminate December 31, 2002. Art equal opportunity employer SH ELL-MCCLU RG-OS2720 Applied Health Sciences Contract No. 2002-100093 Page 2 5. The schedule and requirements for deliverables under this agreement are as follows: Due Date 21 days after the end of each calendar auarter May 2002 Begin 4Ui Quarter 2002 Begin 4ln Quarter 2002 Begin 4lJ1 Quarter 2002 Begin 4111 Quarter 2002 Begin 4lJ1 Quarter 2002 Task/Deliverable Quarterly progress reports IRB ADDlioval of Protocols Enrollme,nt of study subjects (AML and NHL Datients and controls) Interviews of study subjects Acquisitilon of employment records of studY sUibiects Acquisiti10n of exposure data from Shanahai CDC and factories Exposunit assessment of individual study subjects # of coDi8i and medium e-mail to George Woodall woodalla/6laDi.ora Electronic version in MS Word Electronic version in MS Word Electronic version in MS Word Electronic version in MS Word Electronic version in MS Word Electronic version in MS Word 6. AHS and Fudan University have the exclusive right to publish the findings derived from the case-control studies of acute myeloid leukemia and non-Hodgkin's lymphoma. However, AHS shall grant API a royalty-free, irrevocable license to use all reports, drawings, and drafts submitted to API by AHS. API may use such materials in any manner in which API, in its sole discretion, deems fit ~md proper, including submission to governmental agencies, use in litigation, or use in other proceedings before governmental bodies. AHS agrees to preserve the confidentiality 01: information furnished hereunder by API. 7. AHS acknowledges that the protocols and conduct of the research during the life of the agreement are subject to annual review and approval by an independent Scientific Review Panel (SRP), as well as by an Ethics Review Panel (ERP), both of which API will establish. These panels shall be notified immediately when a change in protocol is proposed. Both the SRP and the ERP must sipprove any significant changes in protocol that would affect the scope of work. 8. Draft presentations and manuscripts will be provided to the SRP for comment in advance. Applied Health Sciences and Fudan University Medical Center will carefully consider each and every comment from the SRP. However, the preparation of presentations and manuscripts is the sole respclnsibility of AHS in collaboration with Fudan University. AHS and Fudan University will have complete control of the content of the presentations and manuscripts. 9. API shall have the right at all reasonable times during the course of the study, and for a one (1) year period following com pletion of the study, to inspect AHS' facilities, including equipment and technical and financial records relating to the work conducted hereunder, for the purpose of insuring confclrmance with this agreement and with generally accepted good scientific practices, and to ve,rify the accuracy of invoices. Such inspection shall include the right to photocopy records PEtrtaining to work conducted hereuhder, excluding individual timesheets of project personnel and information on study participants. 10. It is agreed that either party (API or AHS) shall have the right to terminate this agreement by giving a thirty (30) day written notice of such termination to the other party. Upon receipt of such notice of termination, AHS shall cease incurring costs on this project, except with the prior approval of API for such costs which are necessary to close out the project. In the event of such termination, API's sole obligation will be to reimburse AHS for actual costs (professional fees and direct expenses) incurred as of the date of termination and SHELL-MCCLURG-OS2721 Applied Health Sciencel:. Contract No. 2002-100093 Page 3 subsequent costs (professional fees and direct expenses) incurred with prior approval of API. In no event shall such payment include costs and/or anticipated fees for unperformed work or exceed the maximum amount of the agreement as set forth in paragraph 3. AHS agrees to complete any tasks in progress, should API so request. 11 . It is understood that AHS is acting as an independent contractor in its performance of any and all work hereunder. AHS shall hold API, its members, officers and employees harmless from any omissions or acts ()f negligence on the part of AHS or its designates. 12. Upon request of API, AHS a!grees to defend its work hereunder and to offer testimony thereon to governmental bodies (legislative, executive or judicial). API shall pay expenses (professional fees and direct costs) for such services at AHS' billing rates in effect at the time the services are rendemd. 13. NO CHANGE, MODIFICATION, EXTENSION, TERMINATION, OR WAIVER OF THIS AGREEMENT OR ANY OF THE PROVISIONS HEREOF SHALL BE EFFECTIVE UNLESS MADE IN WRITING AND SIGNED BY A DULY AUTHORIZED OFFICER OF THE PARTY AGAINST WHOM IT IS SOUGHT TO BE ENFORCED. CHANGES BINDING ON API MUST BE IN WRITING AND SIGNED BY AN AUTHORIZED API OFFICIAL. 14. AHS will not use the tradema.rk or name of the American Petroleum Institute or any abbreviation thereof, in any publicity, advertising, or for other promotional purposes without the prior written approval of API. However, AHS may acknowledge API as the sponsor of the research, and shall so advise API in writing. 15. In the event of inconsistencies between this agreement and its attachments, the express terms of this agreement shall govern. 16. Paragraphs 6-16 shall survivE~ the termination of this agreement. If the above terms and conditions are acceptable, please sign below and return one original signed copy of this agreement to API. APPLIED HEALTH SCIENCES AMERICAN PETROLEUM INSTITUTE Otto Wong Chief Epidemiologist and Date: _fn_M__~_2_Z.~~_2_tJ._tJ__L __ nG. William Frick Vice President, General Counsel Secretary ~c, ~ tl~~,-'JA Brenda S. Hargett I Chief Financial Officer Date: '-1Yl. OM! :JiJ, :J{)O~ SH ELL-MCCLU RG-OS2722 American Petroleum Institute 1220 LStr, .}wthwest Washington, DC 20005-4070 (202) 682-8240 Fax (202) 682-8029 Email frick@api.org G. William Frick Vice President, General Counsel &Secretary Otto Wong, Sc.D. Applied Health Sciences 181 Second Avenue, Suite 628 P. O. Box 2078 San Mateo, CA 94401 Contract No. 2002-100093 Amendment No. 1 Dear Dr. Wong: The above agreement between the American Petroleum Institute (API) and Applied Health Sciences (AHS), for work related to a multi-year study of benzene-exposed workers in China, is further amended as follows: 1. The API representative for this agreement is changed to Bruce Jarnot, Ph.D. (202-6828473; e-mail: jarnotb@api.org). 2. This amendment shall fund activities for calendar year 2003 (representing year 2, quarters 2-4 and year 3, quarter 1) of the 5-year program as outlined in the attached Table 1. 3. AHS agrees to perform the work for calendar year 2003 for an amount not to exceed $432,511. This r.epresents the relevant portions of the year 2003 budget as detailed in the attached Tables, 2, 34 and 5. 4. AHS shall submit semi-annual progress reports to Dr. Jarnot via e-mail. In all other respects, the terms and conditions of the above agreement, as amended, shall remain in full force and effect. If the foregoing is acceptable, plea.se sign below and return one copy of this letter to API. APPLIED HEALTH SCIENCES .~~ Otto Wong Chief Epidemiologist and President Date: _,_-_1_'1-_-_0__3 _.___ AMERICAN PETROLEUM INSTITUTE d~nC~k ~ Vice President, General Counsel & Secretary ~Stkr~ Date: _"'.L1_--===1!.=-,.,,::~~3=~---_ An equal opportunity employer SHELL-MCCLURG-052723 American Petroleum Institute 1220 LStreet, NorttM-. Washington, DC 20005-4070 Tel 202-6IH34O FIX 202-682-8270 .-EoJIIIIl feldman0 api.org Howard Feldman Director Regulatory Analysis &Scientific Affairs Otto Wong, Sc.D. Applied Health Sciences 181 Second Avenue, Suite 628 P. O. Box 2078 San Mateo, CA 94401 Contract No. 2002-1000093 Date extension and Change I., API Representative Dear Dr. Wong: The above agreement between the American Petroleum Institute (API) and Applied Health Sciences (AHS), for work related to a multi-year study of benzene-exposed workers in China, is amended as follows: 1. The termination date is extended from December 31, 2002 to December 31, 2003. 2. The API representative for this agreement is changed to Lorraine Twerdok, Ph.D., DABT (202-682-8344; e-mail: twerdokl@api.org). All correspondence, reports and invoices related to this agreement shall be sent to her attention at the above address. In all other respects, the terms a.nd conditions of the above agreement shall remain in full force and effect. c: Lorraine Twerdok, Ph.D., DABT James M. Vail, Ph.D. SH ELL-MCCLU RG-OS2724 American Petroleum Institute 1220 LSt~rthwest Washington, DC 20005-4070 (202) 682-8240 Fax (202) 682-8029 E-mail frick@api.org G. William Frick Vice Pres_t, General Counsel & Secretary Mr. Robert Schooling APCO Worldwide Inc. 1615 L Street, NW Suite 900 Washington, DC 20036 Contract No. 2002-100098 Dear Mr. Schooling: This letter confirms the agreement between the American Petroleum Institute (API) and APCD Worldwide Inc. (APCD) for the provision of public affairs, public relations and government relations support to the Benzene Health Research Consortium (BHRC). The agreement shall be comprised of (1) a monthly retainer with associated tasks (Section III, Process, of APCO's February 14, 2002 memorandum to BHRC Members), and (2) development and implementation of a communications plan for the BHRC (Section II, Recommended Tactics, of APCD's memorandum mentioned above. APCO shall perform the work under this agreement as specified in its February 14, 2002 memorandum BHRC members and accompanying table (Appendix A) and fee schedule (Appendix B), which are attached and made a part hereof. The following terms and conditions will govern the agreement: 1. The entire agreement shall begin on March 1,2002. The retainer portion of the agreement shall terminate February 28, 2003, and the remainder of the agreement shall terminate upon API's acceptance of all deliverables outlined in paragraph 8 below. 2. APCO's principal representative for this agreement shall be Robert Schooling. APCO shall give API prior written notice of any replacement of the principal representative or material reduction in the level of effort of the principal representative in fulfilling this agreement. API shall have the right to approve a material reduction in effort and, in the case of replacement of the principal representative, API and APCO shall jointly agree on a replacement. 3. This agreement will be under the direction of Howard J. Feldman, Regulatory Analysis & Scientific Affairs Director, American Petroleum Institute, 1220 L Street, NW, Washington, D.C. 20005, or whomever he designates. The designated API representative for work conducted hereunder is Matthew Todd (202-682-8319; e-mail: toddm@api.org). APCD shall send all correspondence and reports relating to this agreement to his attention at the foregoing address. 4. API's total obligation to APCO for this agreement shall not exceed four hundred sixty thousand five hundred dollars ($460,500) as follows: a. A monthly retainer of $20,000 per month. API shall make the first two retainer payments within 10 days of receiving a signed agreement from APCD. Thereafter, API shall pay An equal opportunity employer SHELL-MCCLURG-052725 APCO Worldwide Inc. Contract No. 2002-100098 (revised final) Page 2 the monthly retainer fee to APeO by the first of each month for that month. The total retainer fee for this agreement shall not exceed $240,000. Services outlined in Section III of APCO's February 14, 2002 memorandum shall be defined as "retainer services," and shall be applied against the retainer. Unused retainer fees can be carried over to the next month(s). (For the avoidance of doubt, API shall continue to make monthly retainer fee payments of $20,000, notwithstanding any unused fees.) At the end of the agreement period, APCO shall return any unused retainer balance to API. b. An amount not to exceed $180,500 for the following tasks under Section II of APeO's February 14,2002 memorandum and Appendfx"Ato-thwagreement;ctLB, II.F,ILH, II.K1, II.K2, and II.M. APeO shall bill API at the rates set forth in Appendix B to this agreement, and the cost for each individual task shall not exceed the associated amount shown in Appendix A. API and APeO shall contract for additional tasks via task order and amendment to this agreement, which both parties shall sign before work commences. Such task orders and amendments shall include a scope of work, deliverables and associated costs, including compensation and expenses, and shall be automatically incorporated by reference herein upon execution by the parties. c. Related expenses not to exceed $40,000. Such expenses shall include but not be limited to reproduction, postage, telephone and travel. APeO shall receive advance written authorization from API before committing to any travel expenses or other expenses over $2,500. Reimbursement of travel expenses shall be limited to coach class transportation and reasonable accommodations if travel is requested by API. An original receipt or copy thereof must support claims for reimbursement of expenses of fifty dollars ($50.00) or more. APeO shall invoice API on a monthly basis for work completed during that month, payable within thirty (30) days of API's receipt of the invoice. Each invoice shall separately list the amount being billed for each task. Said invoices must reference the above contract number and shall be submitted to Matthew Todd. API may withhold up to ten percent (1 0%) of the agreement amount, pending API's acceptance of all work products and programs under this agreement. 5. APeO shall comply with all applicable laws and regulations in its performance hereunder, and shall be responsible for such registration and reporting as may be required for both APeO and API. Further, APeO agrees to comply with any other applicable lobbying or ethics laws and regulations in its performance hereunder. Finally, APeO's relationships with public officials and candidates for public office will be maintained in such a manner as to avoid any impropriety. 6. During the period of this agreement, APeO shall not represent or engage in efforts for any other party or entity on matters or issues that conflict with positions taken by API with respect to benzene health research. APeO shall immediately notify the API designee if he/she becomes aware of the existence of a conflict or potential conflict. APeO shall not release any information concerning work hereunder to anyone outside API, without prior written approval of API, except for reports required by law. 7. No director, employee or agent of APeO shall give or receive any commission, fee, rebate, gift or entertainment of Significant cost or value in connection with the work hereunder, nor SH ELL-MCCLU RG-OS2726 APeo Worldwide Inc. Contract No. 2002-100098 (revised final) Page 3 enter into any business arrangement with any director, employee, or agent of API other than as a representative of API. APeD shall promptly notify API of any violation of this paragraph. Any consideration received as a result of such violation shall be paid over or credited to API. API may audit relevant records of APeO and any such vendor or subcontractor in connection with the work performed hereunder, for the sole purpose of determining compliance with this paragraph. 8. APCD shall perform the tasks and prepare deliverables specified in APCD's February 14, 2002 memorandum. Upon signature of this agreement, APCD and API shall establish a mutually agreeable schedule for tasks and'oeHverablesto ensure the objectives'Oi"tiTe' ,..."'''"' ..., .~- .. r benzene health research program and this agreement are met in a timely manner. The schedule shall be signed by both parties and automatically incorporated by reference herein upon execution. 9. All reports, drawings, drafts, data and other documents developed hereunder, and the right to copyright such reports, drawings, drafts, data and other documents, shall be the property of API. API may use such materials in any manner in which API, in its sole discretion, deems fit and proper, including submission to governmental agencies, use in litigation, or use in other proceedings before governmental bodies. APCD will not use the aforementioned items or other material developed therefrom, or release the content or findings of the work performed hereunder to parties outside API without prior review and written approval from API, unless they are in the public domain or are otherwise publicly released by API. APeD agrees to preserve the confidentiality of information furnished hereunder by API. 10. API shall have the right at all reasonable times during the course of the agreement, and for a reasonable period following termination of the agreement, to inspect APCD's offices, including financial records relating to the work conducted hereunder, for the purpose of ensuring conformance with this agreement, and to verify the accuracy of invoices. Such inspection shall include the right to photocopy records pertaining to work conducted hereunder, excluding individual timesheets. 11. It is agreed that API shall have the right to terminate this agreement by giving a thirty (30) day written notice of such termination to APeO. Upon receipt of such notice of termination, APeD shall cease incurring costs on this project, except with the prior approval of API for such costs which are necessary to close out the project. In the event of such termination, API will reimburse APCD for actual costs incurred as of the date of termination and subsequent costs incurred with prior approval of API, and APeD will return any unused retainer fees to API. In no event shall such payment include costs and/or anticipated fees for unperformed work or exceed the maximum amount of the agreement as set forth in paragraph 4. 12. Upon termination of this agreement, APeD shall return to API any information furnished hereunder by API, together with all documents, data or other material developed therefrom. 13. It is understood that APeO is acting as an independent contractor in its performance of any and all work hereunder. APeD shall be solely responsible and liable for reasonable attorneys' fees incurred by API due to APeD's negligent or willful misconduct, and the payment of all legal damages awarded to its employees or agents, or to any other person or persons, in SH ELL-MCCLU RG-OS2727 APCO Worldwide Inc. Contract No. 2002-100098 (revised final) Page 4 connection with the performance of this agreement due to any negligent act or omission on APeD's part in connection therewith. APeD shall hold API, its members, officers and employees harmless from such claims, liability, or damages. API shall be solely responsible and liable for any loss or expense, including reasonable attorneys' fees incurred by APeD as the result of any claim, suit or proceeding made or brought against APeD, or in which APeD is asked to participate, based upon any materials provided by API, as well as any claim or suit arising out of the nature or use of API's products, except for losses or expenses that result from APCO's negligence or willful misconduct. API shall hold APCD, its members, officers and employees harmless from such-elaims, liability, or damages. 14. APeD will not use the trademark or name of the American Petroleum Institute or any abbreviation thereof, in any publicity, advertising, or for other promotional purposes without the prior written approval of API. 15. The laws of the District of Columbia (except the conflict of laws provision thereof) shall govern this agreement. 16. The terms and conditions of this agreement may only be modified in writing and signed by an authorized official of the both parties. 17. Paragraphs 7-17 shall survive the termination of this agreement. If the above terms and conditions are acceptable, please sign below and return one original signed COpy of this agreement to API. APCO WORLDWIDE INC. 4~By: AMERICAN PETROLEUM INSTITUTE By: 4if)rU-M /4d: :William Frick Vice President, General Counsel & Secretary >__- _Date: ___ {=--.._.. 6__1.-_ _ __ By:~~~--cJ~~{~~~~__~----- Brenda S. Hargett Chief Financial Officer SH ELL-MCCLU RG-OS2728 APCO worldwide February 14,2002 MEMORANDUM TO: FROM: RE: BHRC Members APCO Worldwide Communications Plan Overview and Mission Statement Our charge is to develop a strategic communications plan for the "Shanghai Health Study" incorporating the issues and agreements reached during the Washington, D.C. meeting with members of the Benzene Health Research Consortium (BHRC). Targeted audience comprehension and ultimate acceptance of the study and its results in approximately five years is the primary purpose for employing a strategic communications plan. Informing and updating the key audiences prior to the study's commencement, and consistently throughout the project, demonstrates transparency and maximizes opportunities for study acceptance by removing "process" obstacles at the outset. Accomplishing these objective requires: Actively engaging key audiences through effective outreach; Conveying consistent messages; and Defining the study clearly and emphasizing its potential to advance currently limited scientific and medical conclusions regarding benzene. I. Strategy The project's overarching communications principle is discreet and direct conversations with interested parties, rather than a broad and sustained media campaign. Attaining and preserving credibility, both in the study results when they become available and the information distributed during the investigations, is critical. Three strategic benchmarks for all ensuing communications follow: SH ELL-MCCLU RG-OS2729  Ensure actual and perceived transparency of process, within the accepted norms of scientific research protocols - If the study is to be useful to the Consortium as an instrument to shape public policy it must be conducted, and just as importantly, perceived to be conducted, under absolutely transparent conditions. This means putting in place a variety of mechanisms to ensure that perception aligns with reality throughout the process. Ensuring transparency of process should not in any way impact or interfere with the scientific research protocol. Engage in early and constructive dialogue with stakeholders - The relevant stalceholders: benzene "thought leader&"r NGGs such. as-the-- _--- --. Leukemia Society of America, regulators, remaining industry, trade media, etc. will be the ultimate arbiters of the study's credibility. Demonstrate leadership through open and honest communications - The participating companies have already demonstrated their desire to fulfill their product stewardship responsibilities by funding this study. It will be important to ensure that all actions at all times are conducted in a manner consistent with societal expectations and that the resulting plan recognizes the skepticism with which the work will be viewed by many involved in the process. The known and anticipated challenges to industry related studies only reinforce the need to implement and adhere to a disciplined communications system. Clearly conveying the industry's corporate social responsibility in undertaking this rigorous, independent and scientifically substantial study is the final essential strategic element. II. Recommended Tactics The strategies outlined above provide guiding principles for determining the tools necessary to obtain study acceptance. While the plan's success requires extended involvement by both the BHRC and APCO, once a communications plan is approved, lead responsibility for each tactic will be decided. In this case, lead responsibility means tactic development or production with input from the remaining organization. The BHRC and API possess the comprehensive scientific, technical and industry perspectives while APCO will contribute assessments from the regulatory, governmental, issues management and strategic communications perspective. Listed below are tactics discussed at the Strategy Session; please note that many of these items will be developed simultaneously rather than sequentially. BHRC Communications Plan APCO Worldwide 2 SH ELL-MCCLU RG-OS2730 A. Develop Priority Messages - utilizing the existing fact sheets and input we have already received, APCO will review and recommend priority messages to effectively inform and prepare the targeted audiences for the study upon completion. B. Develop Effective Materials - written materials created for internal and external consumption will vary in purpose and substance. 1. Internal: Regular updates to BHRCJlJ.eJIlbers and identified affiliates as appropriate; Briefing books for spokespeople; and 2. External: existing documents will be reviewed to incorporate the agreed upon priority messages as well as any necessary updates; the finally approved materials will be consistent but also designed to apply to the diverse key audiences as appropriate. Q&A; Study one-pager; Fact sheets: study aims and objectives; unique study features; previous study conclusions; how different from previous studies; PI backgrounds; On location in China: laboratory pictures, official endorsement statements; A complete packet of each of these materials would comprise a "leave-behind" at the conclusion of each audience outreach contact. C. Use ofInter/Intranet A web-site offering study information and materials for the broadest possible audience provides further transparency and precludes charges of secrecy by making the information accessible. As discussed, to attain utmost credibility, the most appropriate venue to host the site would be a university. Using an Intranet site facilitates exchanging information on in one central location on intelligence BHRC Communications Plan APCO Worldwide 3 SH ELL-MCCLU RG-OS2731 gained, audience outreach summaries, contact clearinghouse and calendar updates. D. Design a Brand - to ensure 'credit' and minimize confusion for distributed study information, APCO recommends branding study-related materials. Instituting and maintaining a brand conveys professionalism and contributes additional credibility to the initiative by utilizing coordinated,and consistent: collateral materials; logos; color schemes; contacts; letterhead; an e-mail account; and and a toll-free telephone number. Naming the study is a fundamental part of creating and implementing a brand. The "Shanghai Health Study" was discussed at the Strategy Session as a potential brand. Once a brand has been selected, it would apply to everything as outlined above. Ideally, the brand should reinforce the concept of the study as an independent entity. For clarification, a brand such as the "Shanghai Health Study" refers to the study itself while the BHRC and other involved individuals or organizations would retain and operate under their names rather than adopt the brand or something supplementary. E. Audit Targeted Audiences - conducting soft soundings among the key audiences to identify what mayor may not already be known about the study will assist message and materials development and provide priorities other than those already determined. F. Construct Outreach Matrix - as agreed upon at the Strategy Session, compiling a matrix of all contacts and outreach on the study will be useful in defining the appropriate audience categories and lead to a better assessment of study issues. G. Engage Spokespeople - engaging the correct spokespeople is perhaps the most critical element to successful study acceptance. Since this project is dependent on soft soundings, one-on-one meetings and timely BHRC Communications Plan APCO Worldwide 4 SH ELL-MCCLU RG-OS2732 communications, the spokespeople will be key. To establish credibility, ideally they will have backgrounds similar to their targeted audience and be persuasive study advocates. 2. Internal: BHRC members; Company colleagues recommended by BHRC members; Principal investigators or other involved researchers if available and willing to participate. 2. External: Advisory Council members or "Endorsers". H. Train Spokespeople - message training is highly recommended for all spokespeople since it can be different from skills each person regularly employs in their professional lives. APCO could provide training sessions on: what to expect; effectively delivering main messages; matching message with targeted audience; how to handle hostile meetings; and medium techniques as appropriate. I. Enlist Endorsers - as possible, enlisting noted experts in the field of benzene research or related fields for whom the research will be a major contribution, such as the Leukemia Society of America, bring additional credibility to the project. It should be expected that their main project messages will be narrowly focused on the benefit to be derived from their perspective. Although confirming involvement of ideal Advisory Council caliber might prove challenging, their participation would valuable to enlist. Potential Advisory Council members can be identified through: the soft soundings outreach; benzene thought leaders' contributions; and primary investigators' assessments. BHRC Communications Plan APCO Worldwide 5 SH ELL-MCCLU RG-OS2733 J. Create a Calendar of Year One Events - a carefully assembled calendar of events, containing both study specific and external activities that may create interest in benzene issues, is a useful tool for "outreach" pegs. Such events can provide reasons to contact the appropriate audiences to inform or alert them of the event to reinforce transparency, credibility and communication channels. Event calendars are works in progress that will be updated as information is received. 1. Study-specific: Internal.R,ey~ew.:aQard approval; Funding complete; Laboratory complete; China Strategy Session; Patient recruitment begins; and Research commences. 2. External: HealthWatch release; Lancet article; German Risk Assessment Report; Official "launch" in China; and Benzene Symposium (2003). K. Convene Special Events - some of the events, such as the China Strategy Session, the official "launch" in China and the Benzene Symposium will require additional planning, strategies and materials once confirmed. 1. China Strategy Session: to determine the protocol to follow in China with officials, trade publications, investigators, member and non-member industry representatives in country and others, a Strategy Session focused solely on China will be held. 2. Official Launch in China: study principals and APCO China report that hosting an official launch ceremony is customary and BHRC Communications Plan APCO Worldwide 6 SH ELL-MCCLU RG-OS2734 expected by Chinese officials to celebrate, commemorate and commence the study. Exact timing and launch details will be decided at the China Strategy Session but the initial recommendations have stated that a banquet for the appropriate audiences would constitute an official launch. Therefore, the concept is more an internal debut among those already involved or aware of the study rather than a broad public announcement and media event. 3. Potential Benzene Symposium: As discussed, the Benzene Symposium,as envisioned would not be a BHRC initiative but rather astucly presentation if such a symposium is convened. Any role to be played by associates of the Shanghai Health Study would be relegated to contacting previous planners to gauge their interest in holding another Benzene Symposium, perhaps in 2003. L. Utilize Monitoring - intelligence gathering will rely heavily on conversations and information learned at conferences and through talking to colleagues. 1. Technology: Internet - both general and specific sites~ NexislLexis article searches generally~ and Relevant list-servs. 2. Human Intelligence Gathering: most of this information will be gleaned through conversations and conferences on other relevant subjects. For the information to have the most impact, it will need to be supplied to a central clearinghouse for other BHRC members to access as appropriate. Since networking will play such a major role in monitoring these issues - for both electronic news items a friend sends or colleague tips mentioned casually -- devising an effective way to communicate and maintain this information in a central location for all to access will be important. If agreed upon, an Intranet or closed list-serv could serve this function. BHRC Communications Plan APCO Worldwide 7 SH ELL-MCCLU RG-052735 M. Anticipate Challenges - as discussed in the Strategy Session, numerous situations could provoke a crisis necessitating additional and immediate communications. Although many scenarios can be envisioned, the essential element to implement at the outset is the process to activate in the case of any emergency or potential emergency erupting. That is, although each situation is different, it is necessary to identify core response team components now and think through exactly how to provide authority to act, especially within the BHRC committee structures. APCO has extensive crisis communications experience and can provide a response tool-kit: categories of people to involve, Q1ain messages, methods to getju < . '... . front of a story and ways to contain or neutralize stories, if possible. All activities will naturally depend on the crisis dimensions and location where it occurs - US, EU or China. APCO also recommends familiarizing the chosen core response team with their exact responsibilities by running a role-playing exercise to allow "realtime" participation and thereby identify strengths and weaknesses of the response. III. Process Anticipating and clearly defining internal channels assists effective external communications delivery. Therefore, the three primary strategic communication principles - transparency, engaged stakeholders and open communications - are also applicable to internal exchanges. To ensure consistent information updates, APCO recommends instituting regularly scheduled information updates. Please note, specific updates or reports can be revised to reflect emerging events as well as to better meet committee members' needs to supply updates to their individual companies. A. Quarterly Conference Calls - established and regular team conference calls to provide information exchanges and opportunities to gauge study progress as a group. As discussed at the Strategy Session, these calls are likely to increase during periods of intense activities; such increases will supplement rather than supplant the quarterly calls. B. Activity Reports - APCO will provide monthly activity reports to ensure BHRC members are able to regularly update member companies. As requested, these reports can be expanded for clarification. C. Intranet - given the different time zones involved in this project, an Intranet system would allow communications and information exchanges accessible to the whole team. BHRC Communications Plan APCO Worldwide 8 SH ELL-MCCLU RG-OS2736 D. Quality Control- to ensure all documents are ready for targeted audience consumption, an approved quality control system must be devised and implemented at the beginning. In addition to providing quality information, it will also allow participating members to build in the time necessary to meet project deadlines. Conclusion APCO is enthusiastic about assisting the BHRC members craft and implement an effective communications component ~o t~,,.haI}ghai Hea1th_~!udy. We: believe: the strategies and tactics outlined above are important tools to ensuring ultimate study acceptance by the targeted audiences. Clearly, the study and its results constitute the project's substance. Communicating the study's goals and identifying the context that stimulated the investigators to seek answers to the questions they posited, while secondary in terms of significance, can be considered primary in terms of the role it can play in determining ultimate study success. BHRC Communications Plan APCO Worldwide 9 SH ELL-MCCLU RG-OS2737 AMERICAN PETROLEUM INSTITUTE COMMUNICATIONS PLAN FOR BENZENE HEALTH RESEARCH CONSORTIUM API Contract No. 2002-100098 Appendix A JTasks II. A. Develop Priority Messages x II. B. Develop ----f---XEffective Materials Ilntern~_1 External x--rI -- Lead Organization Supporting Organization s Comments I I APCO APCO APCO API, SHRC Retainer APCO internal report on their work activity i~~~~~r~aI We-b ~-----~~----- X c::,te J.---- _I I __~II. C. Web Sit. .... ........ 1--- _API [ - - - - 1 ~_API .'1 Semi-Public Web 'I ISite for Endorsers II. D. Design A Brand II. E. Audit Targeted Audiences I iX X X I API APCO/API BHRC APCO ** II. F. Construct Outreach Matrix X APCO API, SHRC **$90,000 l II. G. Engage Spokespeople X API SHRC II _ II. H. Train Spokespeople up to X APCO SHRC $14,000 IFee based on numbers trained (J) II. I. Enlist I "Endorsers" XX SHRC APCO ** m r r II. J. Create A s:I Calendar Of One () Year Events IStudy-Specific X () External X ------~~=g~-1-----+----- -- API ~~- . --- - - - ( - - - - API 1 r C ;a G) oI c..n I'V -.....J c..> ex> AMERICAN PETROLEUM INSTITUTE COMMUNICATIONS PLAN FOR BENZENE HEALTH RESEARCH CONSORTIUM API Contract No. 2002-100098 Appendix A r----------- ,-! I Tasks , I Sub-Tasks TIMELINE I Current ~:~~l~~~!~ Org!-~i~:~ion-T~!~~~~~-~:cS) ~S~i:!t~r-------comm~~ts--- i i, I I - ---- --- II.K.Convene K.1. China I i Special Events Strategy Session_' _____X I I APCO BHRC $20,000 K.2 Official ----- Launch in China X APCO BHRC $20,000 K.3 Benzene Symposium X API, BHRC L.1 Technology -:--::-:---------- II. L. Monitoring L.2 Human Intelligence X Gathering X M. Anticipate Challenges Quarterly III. Process Conference Calls X .. - - ---------~----- "- ----- ~- -~-------- Activity Reports -c------- Intranet X X 1------- Quality Control X Ii API - BHRC APCO X APCO, API API, BHRC BHRC ** $14,000 APCO maintains inventory A,ction plan to address critics, ''bad news" q - ----- --- API API API -- - - - - - - - - API APCO -t---- I APCO ------ -- APCO ---- ------- ---- APCO Retainer Retainer Retainer ---------- - Retainer -_ ..._ - - - - --~- ---_. --- -_.- --- -- -- - -- ------- ** Includes third party work: Audit of target audiences, managing outreach programs, assisting with enlisting endorsees, and human intelligence gathering. (J) I m r r sI : () () r C ;a G) oI 2 c.n I'V -.....J c..> <D APC02002 FEE SCHEDULE APCO CHINA 2002 TITLES AND PERSONNEL RATES Title 2002 Rate Managing Director Director Account Manager Consultant $400.00 $300.00 $150.00 $150.00 APCO EUROPE 2002 TITLES AND PERSONNEL RATES Title 2002 Rate Managing Director Associate Director Senior Associate $320.00 $240.00 $200.00 APCO DC 2002 TITLES AND PERSONNEL RATES Title 2002 Rate Senior Vice PresidenVDirector Senior Vice President Vice PresidenVDirector Vice PresidenVDirector Senior Associate Manager Associate Junior Associate Project Assistant Administrative Assistant Intern $315.00 $295.00 $260.00 $230.00 $200.00 $170.00 $140.00 $115.00 $85.00 $65.00 $60.00 API Contract No. 2002-100098 .AppendixB SH ELL-MCCLU RG-OS2740 American Petroleum Institute 1220 LStreet, Northwe'St' Washington, DC 20005-4070 Tel 202-682-8340 Fax 202-682-8270 E-mail feldman@apLorg Howard Feldman Director Regulatory Analysis &Scientific Affairs Mr. Robert Schooling APCO Worldwide Inc. 1615 L Street, NW Suite 900 Washington, DC 20036 Contract No. 2002-100098 Amendment No. 1 Dear Mr. Schooling: The above agreement between the American Petroleum Institute (API) and APCO Worldwide Inc. (APCO), for the provision of public affairs, public relations and government relations support to the Benzene Health Research Consortium (BHRC), is amended as follows: 1. The references to "Retainer" in the agreement and Appendix A to the agreement are deleted. Appendix A is replaced with Appendix A (revised), which is attached and made a part hereof. . 2. In the first paragraph of the agreement, delete the second sentence. 3. In paragraph no. 1, delete the second sentence and replace with: The termination date for the agreement is changed to February 28, 2004. 4. The following changes are made to paragraph no. 4: a. Delete paragraphs 4 a. and 4 b., and replace with a new 4a. as follows: 4. a. Compensation not to exceed $420,500. APCO shall perform the tasks specified in its February 14, 2002 memorandum and Appendix A revised at the rates set forth in Appendix B. b. Paragraph 4 c. shall become paragraph 4 b. In all other respects, the terms and conditions of the above agreement shall remain in full force and effect. If the foregoing is acceptable, please sign below and return one copy of this letter to API. An equal opportunity employer SH ELL-MCCLU RG-OS2741 APCO Worldwide Inc. Contract No. 2002-100098, amendment no. 1 Page 2 APCO WORLDWIDE INC. _ - - - -~ ~ ~ ('-.-..... AMERICAN PETROLEUM INSTITUTE .t;iL. Howa J. Feldman Reg atory Analysis & Scientific Affairs Director ~Hai/Lr= ~ Chief Financial Officer Date: _3......:.)_~..I-0\_3 _ _ _ __ SH ELL-MCCLU RG-OS2742 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Monday, October 20,2003 1:51 PM (GMT) benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org Matt Todd <ToddM@api.org>; benzene-srp@listserve.api.org Shanghai SRP... Memo to the Consortium SRP Memo to Consortium 20 Oct 2003.doc; SRP Memo to Consortium 20 Oct 2003.pdf Benzene Health Research Consortium (BHRC) Technical and Oversight Committees - Attached for your review and consideration is a "Memo to the Consortium" from the Scientific Review Panel (SRP) chair, Dr. Jerry Rice, which documents SRP review of Shanghai Health Study research following the 2003 Asilomar annual conference. By copy to Matt, please post a pdf copy of the Memo to the SHS website, Panel Info page, in SRP Member Doc's ... thanks! Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-OS2743 Shanghai Health Study Jerry M. Rice, PhD Chair, Scientific Review Panel 3213 Coquelin Terrace Chevy Chase, Maryland 20815 Tel: +1-301-986-0659 Fax: +1-301-986-5438 E-mail: jmricewas@aol.com Memorandum To: From: Date: Subject: Technical Oversight Committee and Members of the Consortium Jerry M. Rice, Ph.D., Chair, Scientific Review Panel October 17, 2003 Conclusions of the Scientific Research Panel Annual Research Meeting, Asilomar, California, August 2003 Executive Summary A fully equipped and staffed Central Diagnostic Laboratory has been satisfactorily established. This is an important first milestone for all three (CC, DP & ME) studies. The next milestones to be monitored are: 1. Progress in recruitment of cases and controls for all studies; 2. Cost-effective implementation of HIV serology for control subjects in the case-control study; 3. Timely peer-reviewed publication of findings in the scientific literature. Additional endpoints have been identified, which the investigators should consider (with external funding if required). The SRP and ERP have jointly decided to hold future panel meetings during annual research meetings, and to defer recruitment for 3 SRP vacancies. These actions will significantly reduce the budget required for the two external Panels in future years. SH ELL-MCCLU RG-OS2744 2 Current status of investigations in view of the formal objectives and goals previously proposed and accepted for funding by sponsors of the Shanghai Health Study Establishment of the central diagnostic laboratory as a functioning reality, and expanding the number of cooperating institutions to include 23 of the 24 major Shanghai hospitals, are major achievements. It is especially significant that the hospitals that have most recently joined the Study are those that treat the majority of benzene poisoning cases in Shanghai. The enrollment of cases, which has just commenced (July 2003), constitutes a highly significant milestone in this overall research program. The investigators are now in an excellent position to accomplish the specific goals of their respective protocols. As these studies progress, a transition plan for identified cases and an ongoing local role for the clinical laboratory should be considered. For the NHL component of the case-control study, it is imperative to document exposures of both cases and controls to all risk factors for NHL other than benzene, notably to HIV. For HIV, a questionnaire alone is insufficient. Performing the requisite blood test should not be a technical difficulty for the diagnostic laboratory, but the current case-control protocol does not provide for blood samples from controls, and is not funded to do this. As an action item, Drs. Irons and Wong agreed to confer and propose an approach to obtaining HIV data from control subjects. Suggestions for further and/or expanded future studies As the goals of the current studies are progressively reached in future years, the investigators should give consideration to exploring new sources of funding for additional studies that lie outside the work scopes of the current protocols: 1. Establish a Leukemia Tissue Bank An established leukemia tissue bank, consisting of stored frozen cells and serum, will provide a major international resource for future research. These clinically and biologically well characterized tissues could be made available to future studies of many kinds and thus provide a significant asset to the investigators and their institutions. A mechanism should be developed for other investigators to apply for access to these preserved tissues. The National Cancer Institute Clinical Cooperative Groups have developed and published criteria for reviewing concepts or research proposals from other laboratory investigators for access to their tissue SH ELL-MCCLU RG-052745 3 banks. [See: Schilsky RL, Dressler LM, Bucci D, Monovich L, Jewell S, Suster S, Caligiuri MA, Kantoff PW, Compton C. Cooperative group tissue banks as research resources: the Cancer and Leukemia Group B tissue repositories. Clin Cancer Res. 2002 May; 8(5): 943-8]. 2. Include Commonly Evaluated Benzene Biomarkers The current studies of benzene toxicity and carcinogenicity in many ways will be the most sophisticated ever undertaken, notably in the application of modern diagnostic criteria. It is highly desirable that the results of these studies be directly comparable to results of previous studies. This can best be accomplished by adding commonly evaluated biomarkers of benzene exposure and effect. All three of the study protocols describe dose response, and the study protocol of the Molecular Epidemiology Study describes identification of sensitive biomarkers, as a specific aim. These include specific metabolites of benzene present in urine, and chromosome aberrations assessed in peripheral blood lymphocytes by conventional methods. Enumerations of peripheral blood granulocytes and lymphocytes are already being made by standard hematological assays. The urinary concentrations of S-phenylmercapturic acid (SPMA) and trans, trans-muconic acid (T,T-MA), which are minor metabolites of benzene, have recently been validated as highly specific biomarkers of recent benzene exposures (Qu et al. HEI Report #11, 2003). Correlations with external exposures, as measured by personal monitors, have been excellent, with linear relationships even between 0.1 to 1.0 ppm. Other benzene metabolites, such as phenol, catechol and hydroquinone do not show such sensitivity or specificity. It is recommended to include at least urinary excretion of S-PMA in studies that investigate acutely exposed workers. In this same study, conventional chromosome analyses of peripheral blood lymphocyte metaphase spreads also were correlated with benzene exposures. Furthermore, chromosome aberrations and chromatid breaks were correlated also with long term cumulative benzene exposures, as assessed by work histories, etc. FISH analyses of interphase cells (granulocytes and non-stimulated lymphocytes), as well as of metaphase spreads of cultured lymphocytes, showed more variability, suggesting that these newer methods require additional development. Decreases in peripheral blood granulocyte and lymphocyte numbers were also correlated with measured SH ELL-MCCLU RG-OS2746 4 benzene exposures, even though the white blood cell numbers did not drop below normal levels. The reason for including these additional biomarkers in this component of the overall study is to assess benzene internal doses by the best-validated methods currently available. This will add validity to the estimates of (current) external benzene exposures being made by worker histories, work area measurements, etc., that are now the only measures of current exposure levels for the subjects in the Molecular Epidemiological Study. As these latter measures are also those being used to quantify benzene exposures retrospectively in the other two components of the overall study, i.e. the Disease Progression Study and the Case Control Study, the Molecular Epidemiology Study will serve as an internal validation study of the methods, adding credibility to them and thereby to the exposure assessment in the other two studies. Conventional chromosome aberration studies using peripheral blood lymphocytes will not be as sensitive or specific for benzene exposures as the urine metabolite concentrations, but good correlations have traditionally been shown between frequencies of chromosome aberrations and chromatid breaks and benzene - as again verified in the Qu study. This biomarker will link the SHS with the many other studies of benzene's human effects that have preceded it. Furthermore, chromosome aberration frequencies are also correlated with long term benzene exposure levels - something that cannot be assessed using the urine metabolites. Finally, chromosome aberrations appear to have predictive value for the subsequent occurrence of cancer, as shown by studies of Hagman and Bonassi over recent decades. (Note: these chromosome studies will not be mechanistic probes; they will be used as biomarkers of exposure to add validity to the methods currently used to assess exposure.) These biomarker suggestions apply to the Molecular Epidemiology Study only. Urinary metabolites will have no use for measuring the distant past benzene exposures of relevance in the other two studies of the overall SHS, and chromosome changes, although reflecting long-term cumulative exposures, will be difficult to interpret in patients with leukemia and associated diseases. SH ELL-MCCLU RG-OS2747 Participants Richard Albertini Patrick Beatty (observer) Stuart Gagen (observer) Harvey Gheckoway John Gherrie Helmut Greim Robert Herrick Juhana E. Idanpaan-Heikkila Bruce Jarnot (API staff) Richard Larson Guilan Li Jerry Rice Howard Rockette Zong-Liang Xu 5 SH ELL-MCCLU RG-OS2748 SHANGHAI HEALTH STUDY Jerry M. Rice, PhD Chair, Scientific Review Panel 3213 Coquelin Terrace Chevy Chase, Maryland 20815 Tel: +1-301-986-0659 Fax: +1-301-986-5438 E-mail: jmricewas@aol.com Memorandum To: From: Date: Subject: Technical Oversight Committee and Members of the Consortium Jerry M. Rice, Ph.D., Chair, Scientific Review Panel October 17, 2003 Conclusions of the Scientific Research Panel Annual Research Meeting, Asilomar, California, August 2003 Executive Summary A fully equipped and staffed Central Diagnostic Laboratory has been satisfactorily established. This is an important first milestone for all three (CC, DP & ME) studies. The next milestones to be monitored are: 1. Progress in recruitment of cases and controls for all studies; 2. Cost-effective implementation of HIV serology for control subjects in the case-control study; 3. Timely peer-reviewed publication of findings in the scientific literature. Additional endpoints have been identified, which the investigators should consider (with external funding if required). The SRP and ERP have jointly decided to hold future panel meetings during annual research meetings, and to defer recruitment for 3 SRP vacancies. These actions will significantly reduce the budget required for the two external Panels in future years. SH ELL-MCCLU RG-OS2749 2 Current status of investigations in view of the formal objectives and goals previously proposed and accepted for funding by sponsors of the Shanghai Health Study Establishment of the central diagnostic laboratory as a functioning reality, and expanding the number of cooperating institutions to include 23 of the 24 major Shanghai hospitals, are major achievements. It is especially significant that the hospitals that have most recently joined the Study are those that treat the majority of benzene poisoning cases in Shanghai. The enrollment of cases, which has just commenced (July 2003), constitutes a highly significant milestone in this overall research program. The investigators are now in an excellent position to accomplish the specific goals of their respective protocols. As these studies progress, a transition plan for identified cases and an ongoing local role for the clinical laboratory should be considered. For the NHL component of the case-control study, it is imperative to document exposures of both cases and controls to all risk factors for NHL other than benzene, notably to HIV. For HIV, a questionnaire alone is insufficient. Performing the requisite blood test should not be a technical difficulty for the diagnostic laboratory, but the current case-control protocol does not provide for blood samples from controls, and is not funded to do this. As an action item, Drs. Irons and Wong agreed to confer and propose an approach to obtaining HIV data from control subjects. Suggestions for further and/or expanded future studies As the goals of the current studies are progressively reached in future years, the investigators should give consideration to exploring new sources of funding for additional studies that lie outside the work scopes of the current protocols: 1. Establish a Leukemia Tissue Bank An established leukemia tissue bank, consisting of stored frozen cells and serum, will provide a major international resource for future research. These clinically and biologically well characterized tissues could be made available to future studies of many kinds and thus provide a significant asset to the investigators and their institutions. A mechanism should be developed for other investigators to apply for access to these preserved tissues. The National Cancer Institute Clinical Cooperative Groups have developed and published criteria for reviewing concepts or research proposals from other laboratory investigators for access to their tissue Administrative support provided by The American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 SH ELL-MCCLU RG-OS27S0 3 banks. [See: Schilsky RL, Dressler LM, Bucci D, Monovich L, Jewell S, Suster S, Caligiuri MA, Kantoff PW, Compton C. Cooperative group tissue banks as research resources: the Cancer and Leukemia Group B tissue repositories. Clin Cancer Res. 2002 May; 8(5): 943-8]. 2. Include Commonly Evaluated Benzene Biomarkers The current studies of benzene toxicity and carcinogenicity in many ways will be the most sophisticated ever undertaken, notably in the application of modern diagnostic criteria. It is highly desirable that the results of these studies be directly comparable to results of previous studies. This can best be accomplished by adding commonly evaluated biomarkers of benzene exposure and effect. All three of the study protocols describe dose response, and the study protocol of the Molecular Epidemiology Study describes identification of sensitive biomarkers, as a specific aim. These include specific metabolites of benzene present in urine, and chromosome aberrations assessed in peripheral blood lymphocytes by conventional methods. Enumerations of peripheral blood granulocytes and lymphocytes are already being made by standard hematological assays. The urinary concentrations of S-phenylmercapturic acid (SPMA) and trans, trans-muconic acid (T,T-MA), which are minor metabolites of benzene, have recently been validated as highly specific biomarkers of recent benzene exposures (Qu et al. HEI Report #11, 2003). Correlations with external exposures, as measured by personal monitors, have been excellent, with linear relationships even between 0.1 to 1.0 ppm. Other benzene metabolites, such as phenol, catechol and hydroquinone do not show such sensitivity or specificity. It is recommended to include at least urinary excretion of S-PMA in studies that investigate acutely exposed workers. In this same study, conventional chromosome analyses of peripheral blood lymphocyte metaphase spreads also were correlated with benzene exposures. Furthermore, chromosome aberrations and chromatid breaks were correlated also with long term cumulative benzene exposures, as assessed by work histories, etc. FISH analyses of interphase cells (granulocytes and non-stimulated lymphocytes), as well as of metaphase spreads of cultured lymphocytes, showed more variability, suggesting that these newer methods require additional development. Decreases in peripheral blood granulocyte and lymphocyte numbers were also correlated with measured Administrative support provided by The American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 SHELL-MCCLURG-052751 4 benzene exposures, even though the white blood cell numbers did not drop below normal levels. The reason for including these additional biomarkers in this component of the overall study is to assess benzene internal doses by the best-validated methods currently available. This will add validity to the estimates of (current) external benzene exposures being made by worker histories, work area measurements, etc., that are now the only measures of current exposure levels for the subjects in the Molecular Epidemiological Study. As these latter measures are also those being used to quantify benzene exposures retrospectively in the other two components of the overall study, i.e. the Disease Progression Study and the Case Control Study, the Molecular Epidemiology Study will serve as an internal validation study of the methods, adding credibility to them and thereby to the exposure assessment in the other two studies. Conventional chromosome aberration studies using peripheral blood lymphocytes will not be as sensitive or specific for benzene exposures as the urine metabolite concentrations, but good correlations have traditionally been shown between frequencies of chromosome aberrations and chromatid breaks and benzene - as again verified in the Qu study. This biomarker will link the SHS with the many other studies of benzene's human effects that have preceded it. Furthermore, chromosome aberration frequencies are also correlated with long term benzene exposure levels - something that cannot be assessed using the urine metabolites. Finally, chromosome aberrations appear to have predictive value for the subsequent occurrence of cancer, as shown by studies of Hagman and Bonassi over recent decades. (Note: these chromosome studies will not be mechanistic probes; they will be used as biomarkers of exposure to add validity to the methods currently used to assess exposure.) These biomarker suggestions apply to the Molecular Epidemiology Study only. Urinary metabolites will have no use for measuring the distant past benzene exposures of relevance in the other two studies of the overall SHS, and chromosome changes, although reflecting long-term cumulative exposures, will be difficult to interpret in patients with leukemia and associated diseases. Administrative support provided by The American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 SH ELL-MCCLU RG-OS27S2 Participants Richard Albertini Patrick Beatty (observer) Stuart Cagen (observer) Harvey Checkoway John Cherrie Helmut Greim Robert Herrick Juhana E. Idanpaan-Heikkila Bruce Jarnot (API staff) Richard Larson Guilan Li Jerry Rice Howard Rockette Zong-Liang Xu 5 Administrative support provided by The American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 SH ELL-MCCLU RG-OS27S3 From: Sent: To: Cc: Subject: Attach: Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> Friday, October 17, 20037:13 PM (GMT) Sullivan, Nancy E SCC-CBAR <nancy.sullivan@shell.com>; Tholstrup, Susan C SCCHSE <susan.tholstrup@shell.com> Iannarone, Lauren B SCC-CSEA <Lauren.Iannarone@shell.com>; Colletti, Sarah J SCC-CSEA <sarah.colletti@shell.com>; Cagen, Stuart Z SCC-HSE <stuart.cagen@shell.com>; Tsai, Shan SP SHLOIL-SHLOIL-HE <Shan. Tsai@shell.com> API Program Oversight Group - Shanghai Health Study letter to Self-Supporting Review Group.doc I have just learned this week that the API Program Oversight Committee is the official API home for the Shanghai Health Study. This is a relatively newly formed committee that is responsible for "non-subscription" programs (i.e. programs not funded by API dues) run by API. Interestingly, Shell has 2 representatives on this committee. Doug Quinn, Shell Oil Products Bruce Reynolds, ChevronTexaco Peter Velez, Shell Exploration and Production To my knowledge, they have not been briefed internally about the program. I would suggest that we offer an opportunity to brief them. Who would be the appropriate person to initiate the contact? ~garcfs) Patsy Patsy Clegg Product Steward Shell Chemical 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: Lorraine Twerdok [mailto:Twerdokl@api.org] Sent: Thursday, October 16, 2003 8: 18 AM To: Benzene OC listserve (E-mail) Cc: Kathleen Combs Subject: BHRC - info. on API Program Oversight Group To BHRC Oversight Committee: As requested on the 10/7/03 conference call, the current members of the API Program Oversight Group - AP 1- SelfSupporting and Special Solicitation Programs are: Doug Quinn, shell Oil Products Bruce Reynolds, ChevronTexaco Peter Velez, Shell Exploration and Production letter to Self-Supporting Review Group.doc A 2001 letter setting out the charter for this group is attached. This letter better explains the group's mission. Also, in requesting this information, Kathleen Combs of API mentioned that the current members are involved only with self-supporting activities, and that the group would welcome participation by a member familiar with the subscription research (termed special solicitation in the letter) programs. SH ELL-MCCLU RG-OS27S4 Please don't hesitate to contact me with comments or questions on this information. -lorraine ****************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 fax: 202-682-8031 email: twerdokl@api.org <mailto:twerdokl@api.org> SH ELL-MCCLU RG-052755 From: Sent: To: Subject: Lorraine Twerdok <Twerdokl@api.org> Friday, February 21,2003 7:56 PM (GMT) toxicology tf (E-mail) <toxtf@api.org>; Benzene consort tech (E-mail) <benzconsorttc@api.org>; Benzene TF listserve (E-mail) <Benztf@api.org> API welcomes Bruce Jamot! To the Toxicology TF, Benzene TF and the SHS Technical Committee: This note is to announce the addition of Bruce Jarnot to API RASA staff. Bruce is our new Senior Toxicologist, replacing George Woodall. Bruce will be staffing the Toxicology and Benzene Task Forces, working on our subscription research Shanghai Health Study on benzene, and handling other health issues as they arise. Bruce has considerable experience with the petroleum industry; before joining API, he provided product stewardship and regulatory support for ExxonMobil Fuels, Lubricants and Solvents businesses, and chaired ACC's Ketones Panel and Hydrocarbon Solvents Toxicology Task Force. Earlier in his toxicology career, Bruce worked with the US Air Force, providing product safety support for jet fuels, lubricants, and additives. While there, he was an assistant professor at Wright State and Antioch Universities, and coordinated Air Force-funded academic research programs in hydrocarbon metabolism and toxicology. Bruce holds a PhD. in Biochemistry and Molecular Biology from Wesleyan University, and is a diplomate of the American Board of Toxicology. In his spare time, Bruce is an active field mineralogist and teaches SCUBA diving. Bruce and his wife, Miranda, are looking forward to moving to this area with their two boys, Alex (age 7) and Nick (5), after the school year. Bruce can be reached at 202-682-8473 or jarnotb@api.org ****************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 fax: 202-682-8031 email: twerdokl@api.org <mailto:twerdokl@api.org> ********** SH ELL-MCCLU RG-OS27S6 From: Sent: To: Cc: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Friday, February 21,2003 7:00 PM (GMT) Benzene consort comm (E-mail) <benzconsort-cc@api.org>; Benzene consort tech (Email) <benzconsort-tc@api.org>; Benzene OC listserve (E-mail) <BenzConsortOC@api.org> 'myron. c. harrison@exxonmobil. com' (E-mail)<myron.c.harrison@exxonmobil.com> BHRC - revised API Exec Brief China Benzene Paper API Exec Comm 2-18-03 Draft.doc China Benzene Paper API Exec Comm 2-18-03 Draft.doc To AIIAttached for your review for our 2/25 conference call, is the revised briefing paper for the March 18 API Executive Committee meeting. We were not successful in getting Red Cavaney's feedback on the document. I have highlighted one change suggested by Mark Fitzsimmons, since this deletion does change the meaning of the phrase. Thanks, Lorraine SH ELL-MCCLU RG-OS27S7 Draftfor March 18,2003 Meeting First revision 1129103 Second revision 2/7103 Third revision 2118103 Attachment For Action API Executive Committee Issue: The Benzene Health Research Consortium is seeking guidance on options to address a shortfall in funding the industry-sponsored Shanghai Health Study (SHS), A five-year project designed to investigate the potential health effects of benzene, the study has secured $16,5 million of the $22,8 million required to carry it to fruition, Although preparations for the research have begun, this funding gap - - if not closed - - will either compromise the study or lead to its demise, Background: Continued concern about the potential health effects of benzene is reflected by two recent studies that suggest a link between benzene exposure and certain cancers not previously associated with the chemical, The Consortium is thus sponsoring a five-year study in Shanghai, China, which could significantly decrease the uncertainty surrounding the issue, A joint investigation primarily managed by the University of Colorado and Fudan University, the SHS includes protocols developed with the assistance of a 12-member international scientific review panel and Chinese, European and American bio-ethics specialists, It also has strong support and active participation from Chinese universities, hospitals and regulatory agencies, The USEPA has agreed to actively participate in the project The quality of Shanghai's occupational benzene exposure records offers an unprecedented opportunity, and perhaps the last of its kind, to study the relationship between benzene exposure and the risk of certain blood diseases, The SHS will enhance industry's product stewardship, while providing the scientific, regulatory and business communities with better information on benzene, Project Status: Three inter-related studies are underway: (1) a Case-Control Epidemiology study; (2) a Disease Progression Study; and (3) a Molecular Epidemiology Study, Laboratory construction, technical training and exposure assessments are nearing completion and individual case acceptance will begin in spring, 2003, Legal and public affairs expertise has been retained to facilitate Consortium activities, Funding Status: Current funding for the program is projected to run out during the first quarter of 2004, Five companies (BP, ChevronTexaco, ConocoPhillips, ExxonMobil and Shell Chemical Company) have contributed $16,5 million, The initial cost estimate for the study was $19,8 million; the study was initiated with a funding shortfall requiring recruitment of additional funding sponsors to fully fund the study, Subsequent protocol enhancements recommended by independent scientific and ethics review panels led to the final budget of $22,8 million as necessary to complete the five-year study, The Consortium has made presentations to IPIECA, CONCAWE, ARPEL, ACC, and NPRA; held focused discussions with Marathon Ashland, Dow Chemical Company, and Sunoco, and approached Citgo, Dupont, BASF, Lyondell-Equistar, TotalFinaElf, Statoil, AGIP-ENI, ARPEL and Petronas, To date, none of these entities has agreed to join the Consortium and contribute funds, Implications of funding shortfall: The Consortium Technical Committee has studied the impacts of a funding shortfall and determined that, at best, only one of the three studies could be completed with current funds, The reality, however, is that an unclosed gap would result in loss of Chinese collaboration, in which case none of the studies could be completed, In addition to the lost scientific and product stewardship opportunities, this situation could have public relations and legal ramifications, At this point, recruitment of additional members has been unsuccessful and Consortium members are not optimistic that any will commit Given that the study would benefit the entire industry, the Consortium is requesting that API leadership consider whether API can provide support to eliminate the current shortfall, Possible options include API (1) providing direct funding for the study; (2) underwrite the remaining shortfall while recruitment efforts continue with the expectation of being repaid in full or in part by the Consortium; or (3) provide no additional funding for the study, For Action: The Executive Committee is requested to advise the Consortium what assistance API can provide to eliminate the shortfall and allow the SHS to be completed, SH ELL-MCCLU RG-OS27S8 From: Sent: To: Subject: Attach: Paula Podhasky <Podhaskyp@api.org> Thursday, February 20,20033:51 PM (GMT) BenzConsort-OC@api.org; BenzConsort-TC@api.org; BenzConsort-CC@api.org Benzene Recruitment Minutes feb 13 03 Call Summary. doc Attached for you review are the minutes from the 2/13/03 conference call. SH ELL-MCCLU RG-OS27S9 DRAFT BHRC Recruitment Committee Conference Call 13 February 2003 Participants: Patsy Clegg, Shell Bill Broddle, ConocoPhillips Brian Doll, Exxon Mobil Don Burnett, BP Patrick Beatty, ChevronTexaco Shannon Stewart, APCO Jay Stuller, Chevron Texaco Stu Cagen, Shell Lorraine Twerdok, API John Wagner, API Bill Frick, API Matt Todd, API Paula Podhasky, API Jim Vail, API Consultant Agenda Items Introductions and Roll Call - Patsy Clegg Lorraine Twerdok informed participants that the new Benzene Health Research staff toxicologist would begin work on Tuesday, 18 February 2003. Discussion of Draft Briefing paper for Executive Committee- Lorraine Twerdok The committee reviewed the draft briefing paper, identified a few additional changes and requested edits be made immediately with the revised document circulated to the committee as soon as possible. (Lorraine Twerdok and Bill Frick took action item; possibility that Red Cavaney will also review.) Some points: o The consortium is not in cost overrun o Study would benefit all of API Discussion of "Call Sheet" - Lorraine Twerdok Crafted as "talking points" for Mr. O'Reilly. Document needs to emphasize there are no epidemiological studies available to respond to the NCI studies Update on NPRA Presentation - Bill Frick Bill Frick and Myron Harrison gave a presentation to the NPRA Issues Committee Meeting in Houston, TX. o Approximately 16 individuals from the Petrochemical industry o Presentation went well with good questions from audience Discussion of "Why Join Now" Document - Lynn Russo, Matt Todd, Shannon Stewart Finalized Approval of Draft Minutes - Patsy Clegg 29 January 2003 minutes approved SH ELL-MCCLU RG-OS2760 DRAFT Action Item Update - Patsy Clegg Sunoco internal discussion complete o Waiting for consent to have O'Reilly call European Union NGO activity o Patsy Clegg is identifying correct people within Shell to work the issue. PACE: Patsy Clegg is arranging for chief labor negotiator at Shell to contact VP at Pace Communications Committee have update on status of the Laboratory opening ceremony on the 24 February 2003 Call. Other Business - Patsy Clegg OSHA contact is Amanda Edens Member companies need to discuss with their legal representatives whether to have Mark Fitzsimmons participate in the 2003 Annual Meeting Everyone is to review action items Fund for Peace (identified by Genevieve LafflyMurphy) is a human rights group with an interest in China; John Wagner will follow-up by identifying who from BP is a representative to the organization Lorraine Twerdok informed participants that Bruce Jarnot, Ph.D., DABT, will begin working at API the following week. :~::I::::~~~I~I:::~~~~ ACTION ITEMS Owner Lorraine & Bill Frick Matt Todd Action Item Make requested changes to Briefing paper and circulate to committee Post 29 January 2003 minutes (Paula forward finalized version) Communications Committee All John Wagner Status of laboratory opening ceremony Consider whether Mark Fitzsimmons needs to attend annual meeting Follow-up on who within BP is a representative on Fund for Peace Due Date ASAP 25 Feb 2003 BHRC Recruitment Committee Conference Call al:::I~:~:m.:::m~m~ ACTION ITEMS Owner Lorraine Twerdok Action Item Make requested changes to Briefing paper and forward to Patrick Beatty and Jay Stuller Due Date ASAP Status ~ Status ~ SHELL-MCCLURG-052761 DRAFT Patrick Beatty & Paula Podhasky Lynn Russo All Adapt project payout to API calendar year budget Forward names of Exxon Mobil people in Europe to Patsy Clegg Get your companies' view on whether BHRC should contact OSHA / Ms Edens BHRC Recruitment Committee Conference Call J.::~:::II~:i~I:::;~~~ ACTION ITEMS draft under review Owner Recruiters Recruitment Committee Action Item Send to Matt information on the organizational level of your contacts and their responses to joining the consortium Follow-up on European NGO activity Due Date 20 Jan 03 End of March 2003 BHRC Recruitment Committee Meeting :~:::~::::::lai,I~i,i::~m ACTION ITEMS OWIlel Stu Cagen Patrick Beatty Bill Broddle Action Item Provide update onTier 1 recruitment efforts Talk to Chevron CEO about Marathon follow-up (CEO-CEO) Follow-up on likelihood of share increase for ConocoPhillips Due Date monthly Patrick & Bill Frick Paula & Patrick Lynn CC/ All Look into recruiting from Caprolactam producers/users Draft structure slide Review QA document to screen for repetition across recruitment documents Strengthen science perspective in "Why" join now document Elaborate on internal benefits gained by a company through participating in a high quality, state of the are research project Review distributed documents and provide comments back to communication Committee CC will mid February 2003 1/29/03 / fl~~~O~d Status Status On hold Reviewing issue internally In progress In progress SH ELL-MCCLU RG-OS2762 DRAFT CC/ All Bill Frick Lynn John Wagner ALL Owner Lynn Lynn Recruiters John Wagner Stu Cagen Shan Tsai Shannon John circulate with due date Verify that roles and responsibilities are consistent between recruitment documents CC will circulate with due date Identify House Committee Contact/meeting invite Contact Nike for additional information on footwear makers Talk to Genevieve Laffly about international organizations that would have interest in program Think about other possible ongoing organizations/groups and forward info to Matt BHRC Recruitment Committee Conference Call ~:~::::::lii~I~~i::~B.1 ACTION ITEMS Ongoing Action Item Forward Patrick's early "Ethics paper" to Matt for posting on website Review presentation of ethics: I Request narrative on Ethics; 2 consider adding paragraph to key messages document; 3 Review slides and decide whether ethics can be addressed more proactively Due Date 12/10/2002 12/11/2002 Status Receive prior approval from an individual before using their name in recruitment Develop wording for arguments for joining Develop wording for scientific argument for joining Forward CAPA conference information to Lynn Include conferences in recruitment opportunities list Review member contract for TSCA 8e issues ongoing ongoing SH ELL-MCCLU RG-OS2763 From: Sent: To: Subject: Attach: Paula Podhasky <Podhaskyp@api.org> Wednesday, February 12,2003 1:04 PM (GMT) BenzConsort-OC@api.org; BenzConsort-CC@api.org; BenzConsort-TC@api.org; myron. c.harrison@exxonmobil.com BHRC SHS - exec briefing & call sheets -latest draft.msg; Jan 29 03 Call Summary. doc The Recruitment Committee Call is Thursday, 13 February 2003 at 1:00 PM EST. Dial-In #: 866/262-1780 (US) 205/354-0100 (International) Meeting Room: *0495614* (stars required) Agenda Introductions and Roll Call. ......... (Patsy Clegg) Discussion of revised BHRC Briefing paper for the Executive Committee .......... (Lorraine Twerdok) Discussion of Call Sheet.......... (Jay Stuller, Lorraine Twerdok) NPRA Presentation Update....... (Bill Frick, Myron Harrison) Establish Time/Date for next call .......... (Patsy Clegg) (everyone come with calendars available) Discussion of Why Join Now document .......... (Lynn Russo, Matt Todd, Shannon Stewart) Approval of 29 January 2003 Draft Minutes.......... (Patsy Clegg) Action Item Update.......... (Patsy Clegg) Other Business Paula Podhasky SH ELL-MCCLU RG-OS2764 DRAFT BHRC Recruitment Committee Conference Call 29 January 2003 Participants: Patsy Clegg, Shell Bill Broddle, ConocoPhillips Brian Doll, Exxon Mobil Lynn Russo, ExxonMobil Don Burnett, BP Patrick Beatty, ChevronTexaco Shannon Stewart, APCD Mark Fitzsimmons, Steptoe & Johnson Jay Stuller, Chevron Texaco Shan Tsai, Shell Stu Cagen, Shell Lorraine Twerdok, API Bill Frick, API Matt Todd, API Jim Vail, API Consultant Paula Podhasky, API Agenda Items Introductions and Roll Call - Patsy Clegg Discussion of Draft Briefing paper for Executive Committee- Lorraine Twerdok The committee reviewed the draft briefing paper, identified changes and requested edits be made immediately and the revised document forwarded to Patrick Beatty and Jay Stuller. New draft needs to be circulated to the committee prior to the next conference call. o Include implications of no additional funding; direct consequences need to be clearly stated o BHRC asking for guidance therefore no funding options included in Briefing paper o For funding options to be discussed need to be brought up by consortium's member company executive committee representatives during the meeting in March o BHRC committee members need to brief their executive committee member; message needs to be consistent. o Lorraine Twerdok will inquire on format to insure BHRC briefing paper is viewed as an action item and not a discussion piece. Establish Time/Date for Next Conference Call - Patsy Clegg Next Conference Call scheduled for Thursday, 13 February 2003 at 1:00 PM EST Following Call scheduled for Tuesday, 25 February 2003 at 4:00 PM EST Discussion of "Why Join Now" Document - Lynn Russo, Matt Todd, Shannon Stewart The participants reviewed the document and identified changes Lynn Russo and Shannon Stewart will incorporate recommended changes SH ELL-MCCLU RG-052765 DRAFT Lynn Russo will add sentences regarding science and forward to Patrick Beatty and Mark Fitzsimmons. Update on NPRA Presentation - Bill Frick Bill Frick has secured time for BHRC to present at the NPRA Issues Committee Meeting in Houston, TX. Persuasive tact needed to show why this is critical issue for a Downstream CEO. Bill Frick will try to get NPRA Committee roster and forward to BHRC members. Matt Todd will provide BHRC presentation packets for distribution Discussion of "Call Sheet" - Lorraine Twerdok Bullet format recommended Need make case that study is in jeopardy Contact information: add Don Burnett and Nancy Sullivan Jay Stuller will work on document and circulate revised version to committee by 13 February 2003 Approval of Draft Minutes - Patsy Clegg 15 January 2003 minutes approved Other Business - Patsy Clegg OSHA contact is Amanda Edens Member companies need to decide whether BHRC should contact OSHA (MS Edens) Patsy following up internally at Shell on BHRC approaching PACE Sunoco recruitment o Sunoco undergone reorganization o New corporate HSE manager at Sunoco o Don Burnett is keeping tabs on status of issue o Don Burnett will keep Brian Doll in the loop Lorraine Twerdok informed participants that there are 3 members of the ERP (Baruch Brody, Zongliang Xu and Juhana Idanpaan-Heikkila) BHRC Recruitment Committee Conference Call ~~:::lli:~~I:::~~~~ ACTION ITEMS Owner Lorraine Twerdok Action Item Format Briefing paper so API Executive Committee views it as "action Item" (not discussion piece) Due Date ASAP Status -V SH ELL-MCCLU RG-OS2766 DRAFT Lorraine Twerdok Patrick Beatty & Paula Podhasky Lynn Russo & Shannon Stewart Bill Frick & Myron Harrison Matt Todd Lorraine Twerdok Jay Stuller Paula Podhasky Lynn Russo All Don Burnett Make requested changes to Briefing paper and forward to Patrick Beatty and Jay Stuller Adapt project payout to API calendar year budget Make requested changes to "Why Join Now" document and forward to Patrick Beatty and Mark Fitzsimmons Prepare for NPRA presentation Put together BHRC recruitment packets for Bill Frick and Myron Harrison Make requested changes to Call Sheet Revise format of "Call Sheet" (Dow) Finalize1/15/03 minutes forward to Matt Todd for posting Forward names of Exxon Mobil people in Europe to Patsy Clegg Get your companies' view on whether BHRC should contact OSHA I Ms Edens Keep Brian Doll in loop with regards to Sunoco recruitment ASAP ASAP ~ ~ ~ ~ ~ -V ~ BHRC Recruitment Committee Conference Call :~::~:::I~:m:~.:::~mm; ACTION ITEMS Owner Matt Todd Recruiters Lorraine Twerdok Lorraine Twerdok Lorraine Twerdok Paula Podhasky Recruitment Committee Action Item Add column to recruitment matrix to record level in organization that was approached Send to Matt information on the organizational level of your contacts and their responses to joining the consortium Write Recruitment "script" for O'Reilly Write and Circulate 15t draft of executive committee briefing paper Contact Bill Frick about following-up on action items Contact John Wagner about following up on action items Follow-up on European NGO activity Due Date ASAP 20 Jan 03 27 Jan 03 27 Jan 03 16 Jan 03 End of March Status ~ ~ ~ ~ ~ SH ELL-MCCLU RG-OS2767 DRAFT Shannon Stewart Matt Todd Lorraine Twerdok Identify Benzene contact within OSHA 2003 ASAP Draft consortium letterhead; forward to John Wagner for legal review Follow through on IRB issues/ inform Dr. Brody of committee discussion ASAP ~ ~ ~ BHRC Recruitment Committee Meeting :~:::~::::::m~~I~~~:::IBS ACTION ITEMS Owner Mark Fitzsimmons Action Item Contact Lyondell (Joe Spielman) Due Date Matt Todd Stu Cagen Matt Todd Patrick Beatty Bill Broddle Forward Tier 1 spreadsheet to Mark F. Provide update onTier 1 recruitment efforts Provide recruitment information packages (folders) Talk to Chevron CEO about Marathon follow-up (CEO-CEO) Follow-up on likelihood of share increase for ConocoPhillips monthly Lynn Russo Patrick & Bill Frick Paula & Patrick Lynn Matt Identify Sinopec contact Look into recruiting from Caprolactam producers/users Draft structure slide Review QA document to screen for repetition across recruitment documents Strengthen science perspective in "Why" join now document Elaborate on internal benefits gained by a company through participating in a high quality, state of the are research project Check on ability to blackout website links mid February 2003 1/29/03 >- ~ Status ~ Lyondell is aware of project; in poor shape financially ~ ~ On hold Reviewing issue internally ~ In progress In progress -V SH ELL-MCCLU RG-OS2768 DRAFT in dreamweaver CC/ All Communications CC/ All All John Wagner Review distributed documents and provide comments back to communication Committee CC will circulate with due date Update slide presentation (AHS, IRB review) Verify that roles and responsibilities are consistent between recruitment documents CC will circulate with due date Discuss internally whether PACE should be solicited for attendance at annual meeting Identify contact at AFLICIO Bill Frick Lynn Bill Frick Matt John Wagner ALL All All Identify House Committee Contact/meeting invite Contact Nike for additional information on footwear makers Give BHRC presentation at NPRA Change "US" NGO to "North American" Talk to Genevieve Laffly about international organizations that would have interest in program Think about other possible organizations/groups and forward info to Matt Forward list of European NGOs to most appropriate person within your company; forward their recommendations to Matt Plan to participate on a Conference Call in January ongoing Can blackout ~ -V ~ Peg Seminario ~ ~ Ongoing -V ~ Owner Paula Matt BHRC Recruitment Committee Conference Call ~:~::::::li~~!M~~~::~"~ ACTION ITEMS Action Item Draft minutes forward to legal Notify members in Friday Update of any finalized minutes; post minutes to website Due Date ASAP Ongoing Status ~ Ongoing SH ELL-MCCLU RG-OS2769 DRAFT Members Check website; if you are unable to access website contact Matt Weekly Matt Members Lynn Lynn Remove Draft from final documents Contact Matt for documents you are unable to download from site Forward Patrick's early "Ethics paper" to Matt for posting on website Review presentation of ethics: 1 Request narrative on Ethics; 2 consider adding paragraph to key messages document; 3 Review slides and decide whether ethics can be addressed more proactively As needed As needed 12/10/2002 12/11/2002 Patsy Lynn Paula Matt Matt Recruiters Draft 1-pager on committees Prepare packet of all available recruitment documents have available for participants of 12/11/02 meeting Post Dr. Brody's ethics review of the protocols Receive prior approval from an individual before using their name in recruitment 12/11/2002 ongoing ~ -V John Wagner Stu Cagen Communications Lorraine Matt Members Develop wording for arguments for joining Develop wording for scientific argument for joining Review and Edit document list of responses for" Why join now" Draft paragraph that succinctly responds to why join now; forward to Bill Frick and Howard Feldman Remove from document title "Joint SinoUs ... " Review "Joint Sino ... " and "Scope Statement" documents and send comments to Matt 12/05/2002 ~ Morphed into script for recruitment calls -V -V Shan Tsai Shannon Patrick IDon Lorraine Forward CAPA conference information to Lynn Include conferences in recruitment opportunities list Forward Conoco Phillips email regarding share increase to Lorraine Circulate newest version of Rolls and ongoing ~ ~ SH ELL-MCCLU RG-OS2770 DRAFT Paula John Paula Responsibilities paper Include review and approval of Rolls and Responsibilities in DC meeting agenda Review member contract for TSCA 8e issues Add CC critical presentation review to 12/11/2002 recruitment meeting agenda ~ ~ SHELL-MCCLURG-OS2771 From: Sent: To: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Monday, February 10,2003 10:06 PM (GMT) Benzene consort comm (E-mail) <benzconsort-cc@api.org>; Benzene consort tech (Email) <benzconsort-tc@api.org>; Benzene OC listserve (E-mail) <BenzConsortOC@api.org> SHS - exec briefing & call sheets - latest draft China Benzene Paper API Exec Comm 1-26-03 Draft.doc; Shanghai Fundraising Briefppt TO BHRC: Latest version of the API Exec. paper and the call sheet for your review for our 1 PM recruitment call on 2/13. Dial in: 1-866-262-1780 Meeting #: *045613* (stars required) These will also be posted to the website under SHS Update, along with information to join the call. Talk to your Thursday, Lorraine -----Original Message----From: Lorraine Twerdok Sent: Monday, February 10, 2003 3:22 PM To: Patrick Beatty (E-mail) Cc: Mark Fitzsimmons (E-mail) Subject: FW: SHS - exec briefing & call sheets - latest draft Patrick Information in the ppt presentation is fine. The API executive paper is a much more forceful document than it had been previously. I personally like it this way, but we definitely need input from the rest of the consortium, as well as Bill Frick. Also - I have added a point of clarification (highlighted in yellow), requested by Don, on the fact that we always had a shortfall of funds - Don felt the previous version looked like we let the Pis just up the price on us from an original estimate of $16.5 million. Are these ready to circulate for our call next week? Lorraine -----Original Message----From : Beatty, Patrick (PatrickBeatty) [ma ilto: PatrickBeatty@ChevronTexaco.com] Sent: Thursday, February 06, 2003 9:05 PM To: Fitzsimmons, Mark; Lorraine Twerdok; Iynn.b.russo@exxonmobil.com Cc: Stuller, Jay (JayStuller) Subject: FW: SHS - exec briefing & call sheets - latest draft ALL, Attached are two documents that Jay and I (mostly Jay) developed to be used by Dave O'Reilly for discussions with other company CEOs. The word document is also to be submitted to the API Exec. Com. I have reviewed them for accuracy. Mark, please review from the legal perspective. Lorraine and Lynn, If you have serious problems with wording let me know. If you have less serious concerns especially with the PPT document, I don't want to slow this down. Fine tuning on the word document is more valuable for the Word document that will eventually go to the Exec. Com. I really don't want these to have to wait for whole committees to weigh in on the wording. Patrick -----Original Message----- SH ELL-MCCLU RG-OS2772 From: Stuller, Jay (JayStuller) Sent: Tuesday, February 04, 2003 8:55 AM To: Beatty, Patrick (PatrickBeatty) Subject: SHS China Benzene Paper API Exec Comm 1-26-03 Draft.doc Shanghai Fundraising Brief.ppt Hi Patrick: Thanks for the thoughts. I made a few more changes to the briefing paper, to deal with the fact that DJO might be calling someone who'd not really heard of the Consortium or what it's about. As for the background paper, why don't you remove the editing remarks permanently, and then send the package to the folks who need to see it. Jay SH ELL-MCCLU RG-OS2773 The Shanghai Health Study Closing the Gap 1 SH ELL-MCCLU RG-OS2774 esearc Formed under ausplces of API,:~:f}t:"'::t;~ii~f~::;: C~, Primary sponsors of Shanghai Health Study f, Comprised of five companies: BP, Shell Chemical, ChevronTexaco, ExxonMobil and ConocoPh ill ips f' Consortium in need of wider sponsorship 2 SH ELL-MCCLU RG-OS277S Benzene and Health f) Effects of low-level benzene exposure on health is not well understood c") Two recent studies suggest link between benzene and cancers not previously associated with the chemical c~> Benzene an ongoing concern for science, health and regulatory communities t) Uncertainty drives current and future policies and regulations 3 SH ELL-MCCLU RG-OS2776 An Unprecedented Opportunity ::;::: Strong collaboration between U. of Colorado, Fudan U., Chinese Hospitals, regulatory agencies :::;:: Designed with international bio-ethics advisors and meets WHO ethics standards ::;::: Exceptional health and benzene exposure records maintained by cooperating Shanghai authorities i:~::.:~:: $16.5 million of $22.8 million required is already committed. 4 SH ELL-MCCLU RG-OS2777 Additional Sponsors Needed However the $6 3 m-Ill-ion gap::::::t::1::}:~:f::t I jeopard izes the enti re study ~:~:1:!1:1~:; Fu nds sufficient to la unch but not complete the SHS C') We are seeking a one share/$1.5million commitment over next 3 to 4 years C~ Shares proportional to size of sponsor compani-es 5 SH ELL-MCCLU RG-OS2778 Benefits ofConsortium Membership :S::::i:!F::}:i:t Answer quest-IonsI prov-Ide updates Annual summar-IesJ:t:Jtt;~;:~~llj~~l~~r' :4:::!i!W!::}!it: Interact-Ions w-Ith other sponsorsI investigators and participants C~ Opportunity to help SHS gain greater acceptance from health officials, regulators governments and NGO's 6 SH ELL-MCCLU RG-OS2779 Conclusions {:!:~::~:!}~ 10/ En han ce Prod uct Stewa rd5h-I PI Adva nce Corporate Soc-Ia,::f~:}t:, I~;:t;~~;~~:r' Responsibility; C') Add vitaI new data to accepted body of scientific research on benzene; C') Be used as reference by government, industry and regulatory decision-makers. 7 SH ELL-MCCLU RG-OS2780 Draftfor March 18,2003 Meeting First revision 1129103 Second revision 2/7103 Attachment For Action API Executive Committee Issue: The Benzene Health Research Consortium is seeking guidance on options to address a shortfall in funding the industry-sponsored Shanghai Health Study (SHS), A five-year project designed to investigate the potential health effects of benzene, the study has secured $16,5 million of the $22,8 million required to carry it to fruition, Although preparations for the research have begun, this funding gap - - if not closed - - will either compromise the study or lead to its demise, Background: Continued concern about the potential health effects of benzene is reflected by two recent studies that suggest a link between benzene exposure and certain cancers not previously associated with the chemical, The Consortium is thus sponsoring a five-year study in Shanghai, China, which could significantly decrease the uncertainty surrounding the issue, A joint investigation primarily managed by the University of Colorado and Fudan University, the SHS includes protocols developed with the assistance of Chinese, European and American bio-ethics specialists, It also has strong support and active participation from Chinese universities, hospitals and regulatory agencies, The quality of Shanghai's occupational benzene exposure records offers an unprecedented opportunity - - and perhaps the last of its kind - - to study the relationship between benzene exposure and the risk of certain blood diseases, While providing the scientific, regulatory and business communities with new information on benzene, the SHS would also enable industry to enhance its product stewardship reputation, Project Status: Three inter-related studies are proposed: (1) a Case-Control Epidemiology study; (2) a Disease Progression Study; and (3) a Molecular Epidemiology Study, The preinitiation program is currently nearing completion and the principal investigators expect to begin accepting subjects and processing samples from study participants in March or April of 2003, Previous and current Shanghai workplace exposures are being evaluated, while the training of exposure assessment technicians and interviewers is underway, Legal and public affairs expertise has been retained to facilitate Consortium activities, Funding Status: Current funding for the program is projected to run out during the first quarter of 2004, Five companies - - BP, ChevronTexaco, ConocoPhillips, ExxonMobil and Shell Chemical Co - - have contributed $16,5 million, Based on the protocol enhancements recommended by independent scientific and ethics review panels, the Consortium approved a $22,8 million program to complete the five-year study, In seeking additional participation, the Consortium has made general presentations to IPIECA, ACC, CONCAWE and NPRA, and held more focused discussions with Marathon Ashland, Dow Chemical Company, and Sunoco, Several others have been approached, including Citgo, Dupont, BASF, Lyondell-Equistar, TotalFinaElf, Statoil, AGIP-ENI, and Petronas, To date, none of these entities have agreed to contribute funds, Implications of funding shortfall: The Consortium Technical Committee has studied the impacts of a funding shortfall and determined that at best, only one of the three studies could be completed with current funds, The reality however, is that an unclosed gap would result in loss of all Chinese collaboration, in which case none of the studies could be completed, Aside from lost opportunity, this situation could have public relations and legal ramifications, SH ELL-MCCLU RG-OS2781 Draftfor March 18,2003 Meeting First revision 1129103 Second revision 2/7103 For Action: The Executive Committee is requested to decide by [insert date] whether API will (1) provide direct funding for the study; (2) provide funds to allow the study to continue while recruitment efforts continue, anticipating to be repaid in full or in part by the Consortium; or (3) provide no additional funding for the study, SH ELL-MCCLU RG-OS2782 From: Sent: To: Cc: Subject: Attach: Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> Friday, June 10,20053:43 PM (GMT) Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Michael Johnston <Mike. dJohnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Christopher Roythorne (E-mail)<chris.roythorne@uk.bp.com>; Jennifer Galvin (E-mail)<jennifer.b.galvin@conocophillips.com>; Michael Bird (Email) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail) <russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SCC-CF-SS <sc7240l2@shell.com>; Colletti, Sarah J SCC-CSEA <sarah.colletti@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com> Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Matthew Todd (E-mail) <toddm@api.org>; Lorraine Twerdok <twerdokl@api.org> BHRC Committee Chairs Call - June 3 2005 Minutes June 3 2005 Committe Chairs Conference Call - Minutes.zIP ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SH ELL-MCCLU RG-052783 From: Sent: To: Cc: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Wednesday, June 1,2005 5:55 PM (GMT) Benzene OC listserve (E-mail) <BenzConsort-OC@listserve.api.org> Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org>; Benzene consort comm (E-mail) <benzconsort-cc@listserve.api.org> FW: BHRC OC Minutes from 5/3/05 mtg BHRC OC Minutes 5 3 05.doc To BHRC OC Members Please find minutes attached. -lorraine -----Orig inal Message----From: brian.e.doll@exxonmobil.com [mailto:brian.e.doll@exxonmobil.com] Sent: Wednesday, June 01, 200S 1:22 PM To: Lorraine Twerdok Cc: Iynn.b.russo@exxonmobil.com Subject: BHRC OC Minutes Lorraine, Attached are the minutes from the last OC meeting on May 3 at API. Regards, Brian (See attached file: BHRC OC Minutes S 3 OS.doc) SH ELL-MCCLU RG-OS2784 BHRC Oversight Committee Meeting Minutes May 3,2005 Introduction Facility review and antitrust accomplished. Quorum was established. Present: Mike Johnston - Conoco Phillips Russ White - ChevronTexaco Brian Doll - ExxonMobil Lynn Russo - ExxonMobil Pasty Clegg - Shell Chemical Don Burnett - BP Lorraine Twerdock - API John Wagner - API Mark Fitzsimmons - Steptoe Howard Feldman - API Bruce Jarnot - API Budget Discussion Lorraine Twerdock presented the 1Q05 Budget stewardship report which was approved by the Oversight Committee (OC). Minor clarifications were made to several spreadsheets. A final program budget of $26,133,000.00 was approved. The OC discussed and approved the member contribution schedule to ensure API maintains adequate funds to meet financial obligations. ACTION: The payment schedule (Schedule B) will be deleted from Amendment 3. API will work with member company counsel to make minor wording changes to the amendment and will get the final amendment to the OC for approval via email. Technical Committee (TC) contacts will notify Principal Investigators (PI's) once contract Amendment #3 has been executed by all members. API will revise all grants and contracts as appropriate to reflect the new budget. Annual Meeting Lynn Russo presented the Annual Meeting 2005 planning timeline. ACTION: Lynn will work with Jennifer Galvin to see if Jerry Rice would be interested in hosting or participating in a meeting or symposium on November 1 with regulators and interested parties in conjunction with the Annual Meeting; Follow-up discussions would be held with the PI's by the TC contacts; TC to determine if Gary Krieger should be part of SRP/ERP meetings with PI's. TC contacts will work with PI's to revise presentation titles to provide speakers with flexibility. Panel session to be added at the end of the first plenary session chaired by Jerry Rice with a lead off overview by Rich Irons. SH ELL-MCCLU RG-052785  OCITC will meet with PI's for information exchange on sunsetting the study upon its completion and transferring the lab to Fudan. TC will talk with Richards Irons on whether another annual meeting should be held after 2005 or whether a symposium should be scheduled to review results. June 3 Chair's call will be broadened to include TC discussion on Annual Meeting. Process for Media Response Response to the April 29 Houston Chronicle article was discussed ACTION: Patsy Clegg to tell Shawn Tsai to inform Chinese PI about media articles. Technical Committee Update TSCA 8(e) process discussed ACTION: TC to document the process and bring it to the OC for approval. TC contacts to suggest they review the publication process with the PI's as documented in their respective approved protocols. Action Item List List was reviewed and updated. Next Meeting: Conference call was scheduled for June 27,2-4 pm. SH ELL-MCCLU RG-OS2786 From: Sent: To: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Wednesday, June 1,2005 6:02 PM (GMT) Benzene OC listserve (E-mail) <BenzConsort-OC@listserve.api.org>; Benzene consort comm (E-mail) <benzconsort-cc@listserve.api.org>; Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org> FW: BHRC [Committee Chair] Call June 3 @ 9 AM (EDT) Annual Meeting Milestones.doc; BHRC OC Minutes 53 05.doc To all BHRC Committee Members - At the last Oversight Committee meeting, it was decided to open up this weeks Committee Chair call to all members, due to the nature of some of the updates - TC action items from OC Annual meeting planning, SRP/ERP, & funding/budgets. These calls are intended to enhance communication between committees - not to actually work issues. Consequently, they last approx. 45 min - 1 hr at most. The agenda and information to join the call are below. As usual, minutes for the call will be posted to the website once they are finalized. So if you miss the call, you can always review the minutes. Regcwds, La VYCl LV\,e -----Original Message----From: Lorraine Twerdok Sent: Friday, April 29, 2005 1:46 PM To: Lorraine Twerdok; 'Patsy Clegg (E-mail)'; 'Brian Doll (E-mail)'; 'Jennifer B Galvin (E-mail)'; 'Lynn B. Russo (E-mail)'; 'Stuart Cagen (E-mail)' Cc: John Wagner; 'Mark Fitzsimmons (E-mail)' Subject: BHRC Committee Chair Call June 3 @ 9 AM (EDT) As agreed on our call this morning, the next BHRC Committee Chair call will be: Date: Friday June 3, 2005 Time: 9-10 AM,. EDT Dial in: 1-770-765-9147 Pin: 2026828319# Operator Assistance: *0 Draft Agenda: Antitrust -lorraine Assignment of note-taker OC update - Patsy o review of 5/3/05 OC action items for Tech Cmtte (minutes attached below) o status of consortium amendments (all) budget update, if required - Stuart Communications update - Lynn o review Annual Meeting milestones (see attached document) SH ELL-MCCLU RG-OS2787  Technical update - jennifer SRP/ERP update - Stuart/Bruce Legal update - john API update -lorraine AOB Schedule next call Annual Meeting Milestones.doc BHRC OC Minutes S 3 OS.doc Regcwds, La VYCl LV\,e ***************************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 email: twerdokl@api.org fax: 202-682-8031 SH ELL-MCCLU RG-OS2788 From: Sent: To: Cc: Subject: Cagen, Stuart Z SCC-CF-SS <stuart.cagen@shell.com> Wednesday, June 8, 2005 2:15 PM (GMT) 'lynn.b.russo@exxonmobil.com'; Lorraine Twerdok <Twerdokl@api.org> Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Christopher Roythorne (E-mail)<chris.roythorne@uk.bp.com>; Richard Herold (E-mail)<heroldra@bp.com>; Bruce Jarnot <jarnotb@api.org>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Michael Bird (E-mail) <michael.g.bird@exxonmobil.com>; Michael Johnston <Mike.dJohnston@conocophillips.com>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com>; Russell White (E-mail)<russellwhite@chevrontexaco.com>; Colletti, Sarah J SCC-CSEA <sarah.colletti@shell.com>; Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Matt Todd <ToddM@api.org>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com> RE: Shanghai Health Study Annual Meeting - Symposium Day for Investigators I think Patsy should call him as Chair of the Oversight Committee Stuart Cagen Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 1407 Fax: 3325 Other Tel: +1 832 646 3987 Email: stuart.cagen@sheILcom Internet: http://www.sheILcom/chemicals "Business Success through HSSE Excellence" -----Orig inal Message----From: Iynn.b.russo@exxonmobil.com [mailto:lynn.b.russo@exxonmobil.com] Sent: Wednesday, June 08, 2005 8:55 AM To: Lorraine Twerdok Cc: Brian Doll (E-mail); Burnett, Don (E-mail); Christopher Roythorne (E-mail); Richard Herold (E-mail); Bruce Jarnot; Jennifer Galvin (E-mail); Michael Bird (E-mail); Michael Johnston; Myron Harrison (E-mail); Clegg, Patsy M SCC-CHSE-PC; Russell White (E-mail); Colletti, Sarah J SCC-CSEA; Tsai, Shan P SHLOIL-SHS; Stephen Bowes (E-mail); Cagen, Stuart Z SCC-CF-SS; Matt Todd; Valerie Crissey (E-mail); Zach Wong (E-mail) Subject: RE: Shanghai Health Study Annual Meeting - Symposium Day for Investigators Lorraine: Jerry is in charge on this one, and he has asked to work with Bruce. I think a single point of contact is a good idea. If Madeleine is needed Bruce should work with her. I'll call Jerry with the news and establish the path forward: from here on out he'll be working with Bruce and the Technical Committee. Lynn "Lorraine Twerdok" <Twerdokl@api.org> To: "Clegg, Patsy M SCC-CHSE-PC" <patsy.clegg@sheILcom>, "Lynn Russo (E-mail)" <lynn.b.russo@exxonmobiLcom>, "Jennifer Galvin (E-mail)" <jennifer.b.galvin@conocophillips.com> 06/08/0509:48 AM cc: "Brian Doll (E-mail).. <brian.e.doll@exxonmobiLcom>. "Burnett, Don (E-mail).. <burnetdm@bp.com>. "Michael Johnston" SH ELL-MCCLU RG-052789 <Mike.d.Johnston@ConocoPhillips.com>, "Zach Wong (E-mail)" <ZachWong@chevrontexaco.com>, "Bruce Jarnot" <jarnotb@api.org>, "Christopher Roythorne (E-mail)" <chris.roythorne@uk.bp.com>, "Michael Bird (E-mail)" <michaeLg.bird@exxonmobiLcom>, "Russell White (E-mail)" <russellwhite@chevrontexaco.com>, "Shan Tsai (E-mail)" <Shan.Tsai@sheILcom>, "Stephen Bowes (E-mail)" <stephen.m.bowes@exxonmobiLcom>, "Stuart Cagen (E-mail)" <stuart.cagen@sheILcom>, "Colletti, Sarah J SCC-CSEA" <sarah.colietti@sheILcom>, "Matt Todd" <ToddM@api.org>, "Myron Harrison (E-mail)" <myron.c.harrison@exxonmobiLcom>, "Richard Herold (E-mail)" <heroldra@bp.com>, "Valerie Crissey (E-mail).. <vcrissey@chevrontexaco.com> Subject: RE: Shanghai Health Study Annual Meeting - Symposium Day for Investigators Patsy Do you want to contact Jerry Rice with the news, or should API? I am planning on having Madeleine work on the arrangements, unless committee members have other suggestions to facilitate the organization of the workshop. Thanks, Lorraine -----Orig inal Message----From: Clegg, Patsy M SCC-CHSE-PC [mailto:patsy.clegg@sheILcom] Sent: Tuesday, June 07,20055:17 PM To: Lynn Russo (E-mail); Jennifer Galvin (E-mail); Lorraine Twerdok Cc: Brian Doll (E-mail); Burnett, Don (E-mail); Michael Johnston; Zach Wong (E-mail); Bruce Jarnot; Christopher Roythorne (E-mail); Michael Bird (E-mail); Russell White (E-mail); Shan Tsai (E-mail); Stephen Bowes (E-mail); Stuart Cagen (E-mail); Colletti, Sarah J SCC-CSEA; Matt Todd; Myron Harrison (E-mail); Richard Herold (E-mail); Valerie Crissey (E-mail) Subject: Shanghai Health Study Annual Meeting - Symposium Day for Investigators The BHRC Oversight Committee has approved $10,000 for use in sponsoring a symposium for the SHS investigators to meet with and present to government, academies, etc as an additional activity prior to or immediately after the annual meeting this year. Regards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: U' 713 241 2521 Fax: 3325 Email: patsy.clegg@sheILcom Internet: http://www.sheILcom/chemicals Business Success through HSSE Excellence SH ELL-MCCLU RG-052790 From: Sent: To: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Thursday, October 21,20048:29 PM (GMT) benzconsort-tc@listserve.api.org BHRC-TC... conf call SUNDAY (10124) to review draft 3Q04 Financial Report BHRC Program Expenses 3Q04 rpt.xls BHRC Technical Committee (TC) - Attached is the Shanghai Health Study draft 3Q04 Financial Report for discussion & review during a conference call on SUNDAY, October 24th. Fortunately, this was an "off" quarter with little reflected activity, but I do apologize for the short notice and the not-so-great scheduling of this conference call. .. Schedule & Dial-In Information -- Sunday, October 24th -- 6:00am California, 8:00am Houston, 9:00am Eastern -- Phone: toll-free 866/448-6756 -- PIN: 6828319# Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SHELL-MCCLURG-052791 Benzene Health Research Consortium 3Q04 Financial Report Overview A BC D E FG 1 2 RESEARCH PROGRESS: 3 4 Case Diagnosis: JCML clinical lab operating at 100% capacity, processing 30% more cases than anticipated with 99+% concordance between primary diagnosis & secondary pathology review. CDC 5"" transferred & validated at JCML. JCML budget expected to allow case accrual through 4Q06. 6 7 Case Accrual: Logistical issues affecting NHL accrual rate have been successfully resolved. All hospital cases presented are now referred to JCML for diagnosis. Annualized Sept '03 -> Sept '04 refe 8 9 """"iO Exposure Assessment: Exposure Assessment fully operational, and Exposure Re-creation Committee reorganized apart from IPHS. Exposure activities will be highlighted at annual meeting. 11 12 External Review Panels: ERP Chair will be chosen at Asilomar, and Ethics panel will resume independent operation following the annual meeting. New contract for John Cherrie placed with 10M. 13 14 EXPENSE DISCUSSION: 15 16 Fund Balance at API 2Q04: I :P4,152,4361 17 18 19 Irons Field EXl2enses: Total T&E expenses are currently 1% ($15K) over budget and need to be closely tracked. 20 21 UCHSC: $874,030 was disbursed in 3Q04. First-half 2004 total expenses were 100+% (-$1 MM) above budget for current period. Operations, subcontract & equipment expense increases attibuted IT 22 23 Subcontracts: Total UCHSC Subcontractor expenses were -$800K above projected budget, attibuted mainly to increased case review and diagnosis. Detailed subcontractor expenses for the period 24 25 AHS: Labor costs high due to length of time in Shanghai 26 length of time in Shanghai, but travel savings have kept total expenses 1% ($28K) under budget. 27 28 Fudan Universit~:{ 30% additional case load, and transfer of CDC & IPHS activities has increased rate of expenditure, but operations remain well within total budget. 29 30 SRP/ERP: Total expenses 2% ($9K) over budget following 1Q04 budget adjustment and unanticipated 2Q expenses. Unfavorable variance expected to resolve by year end 2004. 31 32 Communications {APCO):cummulative variance of 13% under budget 33 34 Outside Legal Council: cummulative variance of 16% under budget 35 36 QAlQC: proposal requested from Judy Baldwin, per Technical Committee recommendation. 37 38 API Administrative Costs: 3Q04 15% under budget; cummulative variance is 2% under budget. 39 40 FORWARD GUIDANCE: 41 42 SRP/ERP projected expenses need to be re-analyzed to include international travel expenses for the 2005 (Shanghai) and 2006 (Munich) Annual Meetings. These expenses were not included in the 11 43 44 UCHSC grant requires close monitoring due to large 3Q04 expenses and new case-based cost structure 45 46 API administrative expenses requires close monitoring to contain costs. Projected expenses for 2005 will require a substantial decrease in API staff time. Budget projections were based on the assum~ 47 48 Establish new Fudan University and Dr. Irons field expense contracts (in progress). Page 1 of43 &[DATE] SH ELL-MCCLU RG-OS2792 HI 1 2 3 4 analytic activity fully 5"" 6 7 rral rare (650 actual 8 9 """"iO 11 12 13 14 15 16 17 18 19 20 21 ainly to the marked 22 23 obtained from the UC 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 /03 revised BHRC 43 44 45 46 ion that API staffing 47 48 Benzene Health Research Consortium 3Q04 Financial Report Overview Page 2 of43 &[DATE] SH ELL-MCCLU RG-OS2793 Benzene Health Research Consortium 3Q04 Financial Report Overview A 49 50 Need to reconcile UCHSC statement - they have a $105 error (from 4Q03 rpt) 51 52 Technical Budget Work Group Acceptance: 53 Oversight Committee Acceptance: 54 Posted to website: 55 56 57 LT 10/20104 58 BJ 10/21104 BC D E FG Page 3 of43 &[DATE] SH ELL-MCCLU RG-OS2794 H 49 50 51 52 53 54 55 56 57 58 I Benzene Health Research Consortium 3Q04 Financial Report Overview Page 4 of43 &[DATE] SH ELL-MCCLU RG-052795 A 1 2 Item 3 AHSciences Case-Control Study 4 DP & ME Studies (UCHSC) 5 Irons(T & E) 6 Fudan University 7 8 Scientific Review Panel 9 Ethics Review Panel 10 External Pathology & Cytogenetics Workgroups(Cost in UC cost) 11 12 API Seed Monies 13 Outside Counsel 14 Public Affairs 15 QAJQC Activities 16 UCHSC Interest 17 contingency 18 19 20 21 GRAND TOTAL 22 23 Notes by API 24 Notes/Assumptions for Dec. 2001 revised budget: 25 26 27 28 29 LT 10/18/04 Benzene Health Research Consortium Approved Program Budget 3Q04 Financial Report B Total Research Costs Total Panel Costs Miscellaneous Costs Subtotal API Admin. C Original Cost D Approved Revised Cost Estimate (Jan. Estimate (Dec. 2001) 2001) $1,595,000 $13,665,017 $1,253,428 $165,700 $16,679,145 $450,000 $500,000 $1,000,000 $2,283,095 $15,258,017 $1,253,428 $190,555 $18,985,095 $648,000 $216,000 $130,000 $994,000 $0 $500,000 $1,000,000 $225,000 $190,855 $1,690,855 $18,820,000 $941,000 $19,761,000 $0 $1,725,000 $21,704,095 $1,085,205 $22,789,300 E Unapproved Changes not approved (June 2003) $2,283,095 $15,258,000 $1,597,273 $661,000 $19,799,368 $551,736 $192,000 $0 $743,736 $0 $100,576 $960,600 $100,000 $0 $1,161,176 $21,704,280 $1,085,019 $22,789,299 F Approved 11 NOV 03 OC mtg $2,283,095 $14,508,000 $1,413,428 $230,000 $18,434,523 $300,000 $64,000 $0 $364,000 $0 $100,000 $550,000 $100,000 ($100,000) $390,272 $1,040,272 $19,838,795 $1,245,205 $21,084,000 G Approved 21 APR 04 OC mtg $2,283,095 $14,508,000 $1,413,428 $230,000 $18,434,523 $300,000 $64,000 $0 $364,000 $0 $100,000 $550,000 $100,000 $0 $290,272 $1,040,272 $19,838,795 $1,245,205 $21,084,000 - The total research costs have changed as a result of the - Panel costs assume that there will be only one face-to-face meeting for each panel each year. Page 5 of43 &[DATE] SH ELL-MCCLU RG-OS2796 Benzene Health Research Consortium Executive Summary 3Q04 Financial Report AB 1 2 3 4 5 6 7 Cost Centers Project # 8 9 Income 10 11 12 Cost Centers 13 UCHSC* X8105 14 Irons-Field Expense* X8106 15 Applied Health Sciences X8107 16 Fudan University X8108 17 Scientific & Ethics Panels 18 Communications X8109 X8103 19 Outside Legal Counsel X8104 20 QAJQC Support X8110 21 API Administrative 22 Contingency X8100 23 24 Total Expenses 25 26 Fund Balance 27 28 29 blue is projected fund balanced to project 30 * amount disbursed by API 31 32 33 LT 10/18/04 34 35 36 37 38 C DE F G H Inception Thru December 2003 Actuals Actuals Jan - Sept 2004 $ 15,257,275 $ 1,499,127 Program to Date $ 16,756,401 Cumulative Actuals Inception Thru 2Q04 $ 16,756,401 7,515,759 539,486 951,892 31,981 82,854 290,866 33,208 - 594,670 101,473 1,748,061 189,320 274,131 27,755 15,029 2,025 5,230 - 200,226 - $ 10,142,189 $ 2,461,776 $ 5,115,086 $ (962,650) 9,263,820 728,806 1,226,023 59,736 97,883 292,891 38,437 - 794,896 101,473 9,263,820 728,806 1,226,023 59,736 97,883 292,891 38,437 - 794,896 101,473 $ 12,603,965 $ 12,603,965 $ 4,152,436 ** **$1 ,333,5870f fund balance committed I J K L M N0 Budget (actual + projected income & expen 2004 2005 $ 1,461,334 2006 $ 1,461,333 874,030 55,508 196,681 7,287 72,000 15,000 4,175 6,250 64,400 - $ 1,295,330 $ 2,857,106 1,748,060 222,032 441,867 29,148 79,250 60,000 16,698 25,000 123,330 188,799 $ 2,934,184 $ 1,384,256 1,748,060 222,030 449,985 29,148 74,250 60,000 16,698 25,000 123,200 - $ 2,748,371 $97,218 Page 6 of 43 &[DATE] SH ELL-MCCLU RG-OS2797 PQ 1 2 3 ses) 4 5 6 7 2007 8 9$ 1,461,333 10 11 12 13 874,030 14 222,028 15 45,833 16 29,148 17 47,396 18 79,135 19 16,698 20 25,000 21 123,200 22 - 23 24 $ 1,462,468 25 26 $96,084 27 28 29 30 31 Income Detail 32 sponsors 33 2001 seed 34 MAP contrib. 35 API interest 36 UCHSC interest 37 38 TOTAL R Projected Expenses $ 21,140,401 14,508,000 1,450,404 2,360,388 154,467 370,779 507,026 92,706 81,250 1,229,026 290,272 $ 21,044,317 $16,500,000 $15,000 $200,000 $41,401 $0 $16,756,401 S Program Budget $ 21,084,000 14,508,000 1,413,428 2,283,095 230,000 364,000 550,000 100,000 100,000 1,245,205 290,272 $ 21,084,000 Benzene Health Research Consortium Executive Summary 3Q04 Financial Report Page 7 of 43 &[DATE] SH ELL-MCCLU RG-OS2798 Benzene Health Research Consortium Case Accrual 3Q04 A Case Accrual (Case Predictions) ~ ReDorted Cumulativelv ~ AML (120/yr.; 450 total) "I Cases Predicted Cases Accrued Variance NHL (120/yr.; 450 total) Cases Predicted ~ Cases Accrued Variance AA (50/yr.; 188 total)' Cases Predicted U Cases Accrued L<L Variance ~ MDS (60/yr.; 225 total)' Cases Predicted Cases Accrued Variance G:L Benzene Poisoning (10/yr.; 38 total)' Cases Predicted "[ Cases Accrued ~ Variance ~ (+) Variance: above predicte rate of accrual, 24 (-) Variance: below predicted rate of accrual. L~ "Case predictions based on historical estimates; these are not target numbers of cases required for 26 study completion. ~ LT 8/30/04 L~ BJ 8/25/04 BC 2003 1st & 2nd Otr. 3r.d Otr. 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 D 4th Otr. 35 42 7 35 66 31 12 17 5 15 26 11 3 0 -3 E 1stOtr. FG 2004 2nd Otr. 3r.d Otr. 120 150 30 120 139 19 50 58 8 60 97 37 10 12 2 H 4th Otr. IJ K 2005 1stOtr. 2nd Otr. 3r.d Otr. 240 150 -90 240 139 -101 100 58 -42 120 97 -23 20 12 -8 L 4th Otr. MN0 2006 1stOtr. 2nd Otr. 3r.d Otr. 360 150 -210 360 139 -221 300 58 -242 180 97 -83 30 12 -18 P 4th Otr. Q 1stOtr. RS 2007 2nd Otr. 3r.d Otr. 390 150 -240 390 139 -251 312 58 -254 195 97 -98 33 12 -19 T 4th Otr. &[DATE] SH ELL-MCCLU RG-OS2799 uV ESTIMATED STUDY ~ TOTAL PREDICTION ~ "I 390 450 150 150 -240 -300 ~ U L<L ~ G:L "[ ~ ~ 24 L~ 390 139 -251 0 312 58 -254 0 195 97 -98 0 33 12 -19 450 139 -311 188 58 -130 225 97 -128 38 12 -26 26 ~ L~ Benzene Health Research Consortium Case Accrual 3Q04 &[DATE] SH ELL-MCCLU RG-OS2800 Benzene Health Research Consortium Cash Flow Statement 3Q04 Financial Report A INCOME "I Income for Reporting Period Income, Cumulative ~ EXPENSE Actual API Expenses Expense, Cumulative 2 INCOME LESS EXPENSE ~ Reporting Period Cumulative ~ blue designates projected income or 14 expense LT10/18/04 B 2000 1st-4thQtr. C 2001 1st-4thQtr. D 2002 1st-4thQtr. E 1st&2nd Qtr. $60,246 $60,246 $2,113,132 $2,173,378 $8,367,446 $10,540,824 $448,024 $10,988,848 24,600 $24,600 1,577,811 $1,602,411 7,652,678 $9,255,088 318,759 $9,573,847 $35,646 $35,646 $535,321 $570,967 $714,768 $1,285,736 $129,265 $1,415,001 NOTE: $4,152,436 in bank at API F 2003 3rd Qtr. G 4thQtr. $3,186 $10,992,034 $4,265,241 $15,257,275 258,097 $9,831,945 310,244 $10,142,189 ($254,911) $1,160,089 $3,954,997 $5,115,086 H 1stQtr. $1,485,875 $16,743,149 66,019 $10,208,207 $1,419,856 $6,534,942 I 2nd Qtr. 2004 J 3rd Qtr. $6,746 $16,749,895 $6,506 $16,756,401 1,348,626 $11,556,834 1,047,131 $12,603,965 ($1,341,880) $5,193,061 ($1,040,625) $4,152,436 K 4thQtr. $0 $16,756,401 $12,603,965 $0 $4,152,436 L 1stQtr. $0 $16,756,401 $12,603,965 $0 $4,152,436 M 2nd Qtr. 2005 N 3rd Qtr. $0 $16,756,401 $0 $16,756,401 $12,603,965 $0 $4,152,436 $12,603,965 $0 $4,152,436 0 4thQtr. $0 $16,756,401 $12,603,965 $0 $4,152,436 P 1stQtr. $0 $16,756,401 $12,603,965 $0 $4,152,436 Q 2nd Qtr. 2006 R 3rd Qtr. $0 $16,756,401 $0 $16,756,401 $12,603,965 $0 $4,152,436 $12,603,965 $0 $4,152,436 10of43 &[DATE] SHELL-MCCLURG-052801 "I ~ 2 ~ ~ 14 S 4thQtr. $0 $16,756,401 $12,603,965 $0 $4,152,436 T 1stQtr. $0 $16,756,401 $12,603,965 $0 $4,152,436 U 2nd Qtr. 2007 V 3rd Qtr. $0 $16,756,401 $0 $16,756,401 $12,603,965 $0 $4,152,436 $12,603,965 $0 $4,152,436 W 4thQtr. $0 $16,756,401 $12,603,965 $0 $4,152,436 X TOTALS $16,756,401 $12,603,965 Benzene Health Research Consortium Cash Flow Statement 3Q04 Financial Report 11of43 &[DATE] SH ELL-MCCLU RG-052802 Benzene Health Research Consortium Program Expense Summary 3Q04 Financial Report AB Cost Centers UCHSC ~ Disbursed Budgeted Actual expense CurrentVariance ~ Cumm Variance Irons - Field Expenses Disbursed Budgeted Actual expense CurrentVariance I "+ Cumm Variance ~ Applied Health Sciences ~ Budgeted Actual expense CurrentVariance I ~ Cumm Variance ~ Fudan University - Case/Control Study L. Budgeted L.. Actual expense ~ CurrentVariance ~ Cumm Variance L.: Scientific & Ethics Panels/cyto wkshop L.I Budgeted ...:. Actual expense ~ CurrentVariance L.: Cumm Variance ')U Communications - APCO ~ Budgeted ~ Actual expense .,)..J CurrentVariance .)"+ Cumm Variance ~ Outside Legal Counsel ~ Budgeted Actual expense CurrentVariance .j~ Cumm Variance ~ QAlQC Support "+ Budgeted "+. Actual expense ~ CurrentVariance ~ Cumm Variance "+;:J Contingency Funds "+t: Budgeted ~ Actual expense ~ "+::;l CurrentVariance Cumm Variance ::>U API Administrative and Overhead ~ Budgeted ~ Actual expense ;,:)..J CurrentVariance ;,:)"+ Cumm Variance 2000 1st-4thQtr. 24,600 (24,600) (24,600 ~ TOTALS ~ Budgeted Actual expense CurrentVariance ::>~ Cumm Variance ~ CUMULATIVE TOTALS Budgeted Expense 0,,) Variance 'UUU 2000 24,600 (24,600) (24,600) 24,600 (24,600) 0"+ Blue: future cumulative variance has no meaning until Expense entered. ~ LT10/18/04 ~ Amt. At UCHSC & Irons Field expo Bank acct c 2001 1st-4thQtr. D 2002 1st-4thQtr. 1,225,000 648,390 523,807 124,583 124,583 6,339,598 3,969,140 3,248,834 720,306 844,889 145,763 3,200 3,157 43 43 393,723 259,060 195,549 63,511 63,554 84,025 136,329 (52,304) (52,304) 435,513 435,406 107 (52,197) 31,303 31,303 31,303 42,751 15,470 27,281 58,584 30,240 18,673 11,567 11,567 120,960 5,122 115,838 127,405 60,000 60,000 60,000 240,000 240,738 (738) 59,262 30,000 30,000 30,000 120,000 13,565 106,435 136,435 13,500 54,000 13,500 13,500 54,000 67,500 65,113 52,046 13,067 11,533 260,448 209,056 51,392 39,859 'UUl 965,771 734,012 231,759 207,159 2001 965,771 758,612 207,159 5,501,872 4,363,739 1,138,133 1,345,292 2002 6,467,643 5,122,351 1,345,292 API disbursed Amt Expensed E 1st&2nd Qtr. 1,230,711 1,717,169 (486,458) 332,137 138,359 89,577 48,782 112,336 216,256 140,665 75,591 23,394 21,376 6,492 14,883 73,467 60,480 9,994 50,486 177,891 125,000 14,564 110,436 169,699 62,500 1,728 60,772 197,207 28,126 28,126 95,626 135,654 145,316 (9,662) 30,197 2,018,461 2,125,505 (107,044) 1,238,248 8,486,104 7,247,856 1,238,248 F 2003 3rd Qtr. IG 4thQtr. 332,137 (48,839) 2,039,466 553,672 1,485,794 1,813,804 69,179 54,382 14,797 127,133 108,128 149,389 (41,261) (17,868) 10,688 8,851 1,837 75,305 30,240 16,984 13,256 191,147 62,500 7,877 54,623 224,322 31,250 31,250 228,457 14,063 14,063 109,689 67,826 74,997 (7,171) 23,026 55,508 169,606 (114,098) 13,035 108,128 90,103 18,025 157 7,288 1,168 6,120 81,425 4,508 32,081 (27,573) 163,574 (196,636) 27,688 (224,324) (2) (210,542) 17,915 (228,457) (109,689) (109,689) 290,272 101,473 188,799 188,799 75,934 88,655 (12,721) 10,305 393,874 312,479 81,394 1,319,642 2003 8,879,977 7,560,335 1,319,642 $12,603,965 $11,351,559 $1,252,406 2,064,237 1,082,361 981,876 2,301,518 10,944,214 8,642,696 2,301,518 HI 1stQtr. 1,813,804 55,508 43,945 11,563 24,598 98,340 98,340 98,497 7,288 7,288 88,713 (163,074) 500 (163,574) 15,001 15,001 14,999 4,175 365 3,810 3,810 6,250 6,250 6,250 2004 2nd Qtr. IJ IK 3rdQtr. 4thQtr. 874,031 827,532 2,045,114 (1,217,582) 586,386 874,030 586,386 874,030 827,532 827,532 1,404,082 189,320 55,508 95,409 (39,901) (15,303) 55,508 55,508 40,205 55,508 55,508 95,713 98,340 168,623 (70,283) 28,215 98,340 105,508 (7,168) 21,047 98,340 98,340 119,387 7,288 27,755 (20,467) 68,246 7,288 7,288 75,534 7,287 7,287 82,821 3,000 12,029 (9,029) (9,029) 4,750 2,500 2,250 (6,779) 72,000 72,000 65,222 15,000 790 14,210 29,209 15,000 1,235 13,765 42,974 15,000 15,000 57,974 4,175 2,995 1,180 4,990 4,175 1,870 2,305 7,294 4,175 4,175 11,469 6,250 6,250 6,250 6,250 12,500 6,250 18,750 6,250 25,000 188,799 188,799 66,700 65,154 1,546 11,851 66,700 73,084 (6,384) 5,467 90,188 109,964 (19,776) 2,281,742 11,034,402 8,752,660 2,281,742 'UU4 2004 1,083,793 2,425,798 (1,342,006) 939,736 12,118,195 11,178,458 939,736 $1,175,224 unspent at UCHSC as of 6130/04 (no expense reporting for 3004) $77,182 In Irons' field exp bank acct as of 6130/04 (3004 exp report outstandinq) $1,252,406 Total as of 6130/04 188,799 72,700 61,988 10,712 16,179 264,011 173,101 90,910 1,030,646 12,382,205 11,351,559 1,030,646 188,799 64,400 64,400 80,579 1,150,492 1,150,492 2,181,138 13,532,697 11,351,559 2,181,138 L IM 1stQtr. 2nd Qtr. 874,030 827,532 1,404,082 827,532 2,221,778 55,508 55,508 151,221 110,467 110,467 229,854 7,287 7,287 90,108 1,500 1,500 66,722 15,000 15,000 72,974 4,175 4,175 15,643 6,250 6,250 31,250 55,508 55,508 206,729 110,467 110,467 340,321 7,287 7,287 97,395 1,000 1,000 67,722 15,000 15,000 87,974 4,175 4,175 19,818 6,250 6,250 37,500 188,799 29,350 29,350 109,929 188,799 26,680 26,680 136,609 229,536 1,053,898 229,536 2,410,674 1,053,898 3,464,572 13,762,233 11,351,559 2,410,674 14,816,132 11,351,559 3,464,572 API disbursed by period (includes pre-payments for UCHSC & Irons Field 24,600 1,577,811 7,652,678 318,759 258,097 310,244 66,019 1,348,626 1,047,131 874,030 874,030 Page 12 of43 &[DATE] SH ELL-MCCLU RG-052803 NI0 5 3rd Qtr. 4thQtr. ~0 0 0 0 ~ 2,221,778 1"1 ~ ~ I~ ~ L. L.. ~ ~ L. L.' ~ ~ L. .)U ~ ~ ,).0 ,)"1 ~ ~ .)~ ~ "I "I, ~ ~ "I;) "It ~ ~ "I" ;)U 2 ~ ;).0 ;)"1 ~ ~ ;)~ ~ 0,) 0"1 ~ ~ 0 55,508 0 55,508 262,237 110,467 0 110,467 450,787 7,287 0 7,287 104,682 4,750 0 4,750 72,472 15,000 0 15,000 102,974 4,175 0 4,175 23,992 6,250 0 6,250 43,750 0 0 0 188,799 40,650 0 40,650 177 259 244,086 0 244,086 3,708,659 5 15,060,218 11,351,559 3,708,659 874,030 827,532 0 827,532 3,039,474 0 55,508 0 55,508 317,745 110,467 0 110,467 561,254 7,287 0 7,287 111,969 72,000 0 72,000 144,472 15,000 0 15,000 117,974 4,175 0 4,175 28,167 6,250 0 6,250 50,000 0 0 0 188,799 26,650 0 26,650 203,909 1,124,868 0 1,124,868 4,833,527 16,185,086 11,351,559 4,833,527 p IQI RI s 2006 1stQtr. 2nd Qtr. 3rd Qtr. 4thQtr. 0 0 0 0 3,039,474 874,030 827,539 0 827,539 3,857,170 0 0 0 0 3,857,170 874,030 827,542 0 827,542 4,674,866 0 55,508 0 55,508 373,253 0 55,508 0 55,508 428,761 0 55,507 0 55,507 484,268 0 55,507 0 55,507 539,775 112,496 0 112,496 673,750 112,496 0 112,496 786,247 112,496 0 112,496 898,743 112,496 0 112,496 1,011,239 7,287 0 7,287 119,256 7,287 0 7,287 126,543 7,287 0 7,287 133,830 7,287 0 7,287 141,117 1,000 0 1,000 145,472 1,000 0 1,000 146,472 4,250 0 4,250 150,722 68,000 0 68,000 218,722 15,000 0 15,000 132,974 15,000 0 15,000 147,974 15,000 0 15,000 162,974 15,000 0 15,000 177,974 4,175 0 4,175 32,341 4,175 0 4,175 36,516 4,175 0 4,175 40,690 4,175 0 4,175 44,865 6,250 0 6,250 56,250 6,250 0 6,250 62,500 6,250 0 6,250 68,750 6,250 0 6,250 75,000 0 0 0 188,799 0 0 0 188,799 0 0 0 188,799 0 0 0 188,799 29,250 0 29,250 233,159 230,966 0 230,966 5,064,493 16,416,052 11,351,559 5,064,493 26,650 0 26,650 259,809 40,650 0 40650 300459 IUO 1,055,905 245,615 00 1,055,905 245,615 6,120,397 6,366,012 2006 17,471,957 17,717,571 11,351,559 11,351,559 6,120,397 6,366,012 26,650 0 26,650 327,109 1,122,907 0 1,122,907 7,488,919 18,840,478 11,351,559 7,488,919 Benzene Health Research Consortium Program Expense Summary 3Q04 Financial Report T IuI V Iw 2007 1stQtr. 2nd Qtr. 3rd Qtr. 4thQtr. 0 0 0 0 4,674,866 874,030 827,542 0 827,542 5,492,562 0 0 0 0 5,492,562 0 827,542 0 827,542 6,310,258 0 55,507.0 0 55,507 595,282 0 55,507 0 55,507 650,789 0 55,507 0 55,507 706,296 0 55,507 0 55,507 761,803 45,833 0 45,833 1,057,072 0 0 0 1,057,072 0 0 0 1,057,072 0 0 0 1,057,072 7,287 0 7,287 148,404 7,287 0 7,287 155,691 7,287 0 7,287 162,978 7,287 0 7,287 170,265 1,000 0 1,000 219,722 1,000 0 1,000 220,722 4,250 0 4,250 224,972 41,146 0 41,146 266,118 19,783 0 19,783 197,757 19,783 0 19,783 217,541 19,784 0 19,784 237,325 19,784 0 19,784 257,109 4,175 0 4,175 49,039 4,175 0 4,175 53,214 4,175 0 4,175 57,388 4,175 0 4,175 61,563 6,250 0 6,250 81,250 6,250 0 6,250 87,500 6,250 0 6,250 93,750 6,250 0 6,250 100,000 0 0 0 188,799 0 0 0 188,799 0 0 0 188,799 0 0 0 188,799 29,250 0 29,250 356,359 169,085 0 169,085 7,658,004 19,009,563 11,351,559 7,658,004 26,650 40,650 00 26,650 383,009 40650 423659 IUr 948,194 0 137,903 0 948,194 137,903 8,606,197 8,744,100 2007 19,957,756 20,095,659 11,351,559 8,606,197 11,351,559 8,744,100 26,650 0 26,650 450,309 988,341 0 988,341 9,732,441 21,084,000 11,351,559 9,732,441 X TOTALS 14,508,000 14,508,000 8,088,596 827,542 6,419,404 0 1,413,428 651,624 539,775 761,803 2,283,095 1,226,023 0 1,057,072 230,000 59,736 7,287 170,265 364,000 97,883 41,146 266,118 550,000 292,891 177,974 257,109 100,000 38,437 61,563 61,563 100,000 0 100,000 100,000 290,272 101,473 0 188,799 1,245,205 770,296 474,909 474,909 21,084,000 11,326,959 9,732,441 9,757,041 21,084,000 11,351,559 9,732,441 O~ 0 874,030 0 874,030 0 874,030 0 874,030 0 0 17,094,739 Page 13 of43 &[DATE] SH ELL-MCCLU RG-052804 Benzene Health Research Consortium UCHSC Grant 3Q04 Financial Report A Grant Payments .q Disbursed ~ Personnel ~ Budgeted Actual expense CurrentVariance ~ Cumm Variance ~ Operating Expenses Budgeted Actual expense ~ CurrentVariance ~ Cumm Variance Subcontracts Budgeted Actual expense ~ CurrentVariance Cumm Variance L' Travel -. Budgeted Actual expense L CurrentVariance L"I Cumm Variance ~ Equipment ~ Budgeted L. Actual expense L" CurrentVariance ::::~ Cumm Variance ~ Indirect Budgeted Actual expense CurrentVariance Cumm Variance UCHSC (x81 05) Cost Centers Budgeted ~ Actual expense ~ CurrentVariance ..)::;1 Cumm Variance qU CUMULATIVE TOTALS ~ Budgeted ~ Expense "f..) Variance TOTALS ~ Blue: future cumulative variance has no meaning until Expense entered. ~ LT10/18/04 ~ BJ10121/04 "I" B 2001 1st-4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. 1,225,000 6,339,598 172,140 172,140 573,160 714,688 -141,528 -141,528 331,316 314,703 16,613 -124,915 13,131 12,177 954 954 378,462 301,522 76,940 77,894 198,373 158,850 39,523 117,417 123,629 123,629 123,629 1,795,030 1,025,372 769,658 893,287 549,014 845,860 -296,846 596,441 23,947 8,647 15,300 15,300 11,340 346 10,994 26,294 $291,568 $291,568 $0 $0 $918,645 $899,642 $19,003 $19,003 $0 $274,508 ($274,508) ($255,505) 2001 2001 $47,922 $47,922 ($0) ($0) $648,390 $523,807 $124,583 $124,583 $648,390 $523,807 $124,583 $279,896 $298,963 ($19,067) ($19,067) 2002 $3,969,140 $3,248,834 $720,306 $844,889 2002 $4,617,530 $3,772,641 $844,889 $140,668 $122,902 $17,766 ($1,301) $1,230,711 $1,717,169 ($486,458) $332,137 $5,848,241 $5,489,810 $358,431 Note: Actual expenses from Progress Report or UC Grants & Contracts Financials. Amt. paid UCHSC to date: Amt. expensed to date: Amt. In UCHSC bank acct: $9,263,820 $8,088,596 $1,175,224 Page 14 of43 &[DATE] SH ELL-MCCLU RG-052805 Benzene Health Research Consortium UCHSC Grant 3Q04 Financial Report "I 2 ~ ~ ~ ~ ~ E 2003 3rd Qtr. ~ L' -. L L"I ~ ~ L L, ~~ ~ .."~ ,,;;) 2003 ~ ~,," "IU 2003 ~ .~" ~ "I;;) "It ~ (Adjusted 4003: $48,839 attributed to UCHSC in 3003 Report has been reallocated to Contingency: $25,000 pre-consortium grant in 2001; $3,600 for IRB Review in 2002; $20,239 for EMBSI "feasibility study" in 2002) ~ (Adjusted 4003: 2001 costs had been double expensed in 2002 column; (-$523,807) adjusment made in 4003) "I" 0 0 0 0 -124,915 0 0 0 117,417 0 0 0 596,441 0 0 0 26,294 $0 $0 $0 ($255,505) $0 $0 $0 ($1,301) $0 $0 $0 $332,137 $5,848,241 $5,489,810 $358,431 F 4thQtr. -48,839 293,007 58,188 234,819 109,904 259,003 150,657 108,346 225,763 988,733 565,870 422,863 1,019,304 4,127 0 4,127 30,421 $350,000 ($274,568) $624,568 $369,063 $144,596 $53,525 $91,071 $89,770 $2,039,466 $553,672 $1,485,794 $1,813,804 $7,887,707 $6,043,482 $1,844,225 G 1stQtr. H 2004 2nd Qtr. 0 874,031 0 0 0 109,904 195,778 211,016 -15,238 94,666 0 0 0 225,763 195,773 364,542 -168,769 56,994 0 0 0 1,019,304 286,990 1,128,507 -841,517 177,787 0 0 0 30,421 9,836 0 9,836 40,257 $0 $0 $0 $369,063 $48,050 $192,340 ($144,290) $224,773 $0 $0 $0 $89,770 $0 $0 $0 $1,813,804 $7,887,707 $6,043,482 $1,844,225 2004 2004 $91,105 $148,709 ($57,604) $32,166 $827,532 $2,045,114 ($1,217,582) $586,386 $8,715,239 $8,088,596 $626,643 UCHSC statement error for travel, off by +$1 05 (4003) I 3rd Qtr. 874,030 0 0 0 94,666 0 0 0 56,994 0 0 0 177,787 0 0 0 40,257 $0 $0 $0 $224,773 $0 $0 $0 $32,166 $0 $0 $0 $586,386 $8,715,239 $8,088,596 $626,643 Page 15 of43 &[DATE] SH ELL-MCCLU RG-052806 Benzene Health Research Consortium UCHSC Grant 3Q04 Financial Report "I 2 ~ ~ ~ ~ ~ ~ L' -. L L"I ~ ~ L L, ~~ ~ ~,,'"t ,,;;) ~ ~,," "IU ~ ~ '"t" ~ "I;;) "It ~ ~ "I" J 4thQtr. 874,030 195,778 0 195,778 290,444 195,773 0 195,773 252,767 286,990 0 286,990 464,777 9,836 0 9,836 50,093 $48,050 $0 $48,050 $272,823 $91,105 $0 $91,105 $123,271 $827,532 $0 $827,532 $1,404,082 $9,542,771 $8,088,596 $1,454,175 K 1stQtr. 0 0 0 0 290,444 0 0 0 252,767 0 0 0 464,777 0 0 0 50,093 $0 $0 $0 $272,823 $0 $0 $0 $123,271 $0 $0 $0 $1,404,082 $9,542,771 $8,088,596 $1,454,175 L 2nd Qtr. 2005 M 3rd Qtr. N 4thQtr. 0 1stQtr. P 2nd Qtr. 2006 Q 3rd Qtr. R 4thQtr. S 1stQtr. 874,030 0 874,030 0 874,030 0 874,030 0 195,778 0 195,778 486,222 0 0 0 486,222 195,778 0 195,778 682,000 0 0 0 682,000 195,778 0 195,778 877,778 0 0 0 877,778 195,778 0 195,778 1,073,556 0 0 0 1,073,556 195,773 0 195,773 448,540 0 0 0 448,540 195,773 0 195,773 644,313 0 0 0 644,313 195,773 0 195,773 840,086 0 0 0 840,086 195,773 0 195,773 1,035,859 0 0 0 1,035,859 286,990 0 286,990 751,767 0 0 0 751,767 286,990 0 286,990 1,038,757 0 0 0 1,038,757 286,990 0 286,990 1,325,747 0 0 0 1,325,747 286,990 0 286,990 1,612,737 0 0 0 1,612,737 9,836 0 9,836 59,929 0 0 0 59,929 9,836 0 9,836 69,765 0 0 0 69,765 9,843 0 9,843 79,608 0 0 0 79,608 9,846 0 9,846 89,454 0 0 0 89,454 $48,050 $0 $48,050 $320,873 $0 $0 $0 $320,873 $48,050 $0 $48,050 $368,923 $0 $0 $0 $368,923 $48,050 $0 $48,050 $416,973 $0 $0 $0 $416,973 $48,050 $0 $48,050 $465,023 $0 $0 $0 $465,023 $91,105 $0 $91,105 $214,376 $0 $0 $0 $214,376 2005 $827,532 $0 $0 $0 $827,532 $0 $2,221,778 $2,221,778 2005 $10,370,303 $10,370,303 $8,088,596 $8,088,596 $2,281,707 $2,281,707 $91,105 $0 $91,105 $305,481 $827,532 $0 $827,532 $3,039,474 $11,197,835 $8,088,596 $3,109,239 $0 $0 $0 $305,481 $0 $0 $0 $3,039,474 $11,197,835 $8,088,596 $3,109,239 $91,105 $0 $91,105 $396,586 $0 $0 $0 $396,586 2006 $827,539 $0 $0 $0 $827,539 $0 $3,857,170 $3,857,170 2006 $12,025,374 $12,025,374 $8,088,596 $8,088,596 $3,936,778 $3,936,778 $91,105 $0 $91,105 $487,691 $827,542 $0 $827,542 $4,674,866 $12,852,916 $8,088,596 $4,764,320 $0 $0 $0 $487,691 $0 $0 $0 $4,674,866 $12,852,916 $8,088,596 $4,764,320 T 2nd Qtr. 2007 U 3rd Qtr. V 4thQtr. 874,030 0 195,778 0 195,778 1,269,334 0 0 0 1,269,334 195,778 0 195,778 1,465,112 195,773 0 195,773 1,231,632 0 0 0 1,231,632 195,773 0 195,773 1,427,405 286,990 0 286,990 1,899,727 0 0 0 1,899,727 286,990 0 286,990 2,186,717 9,846 0 9,846 99,300 0 0 0 99,300 9,846 0 9,846 109,146 $48,050 $0 $48,050 $513,073 $0 $0 $0 $513,073 $48,050 $0 $48,050 $561,123 $91,105 $0 $91,105 $578,796 $0 $0 $0 $578,796 2007 $827,542 $0 $0 $0 $827,542 $0 $5,492,562 $5,492,562 2007 $13,680,458 $13,680,458 $8,088,596 $8,088,596 $5,591,862 $5,591,862 $91,105 $0 $91,105 $669,901 $827,542 $0 $827,542 $6,310,258 $14,508,000 $8,088,596 $6,419,404 W TOTALS 14,508,000 2,935,847 1,470,735 195,778 1,465,112 2,415,153 987,748 195,773 1,427,405 5,752,326 3,565,609 286,990 2,186,717 118,139 8,993 9,846 109,146 $1,944,613 $1,383,490 $48,050 $561,123 $1,341,922 $672,021 $91,105 $669,901 $14,508,000 $8,088,596 $827,542 $6,419,404 $14,508,000 $8,088,596 $6,419,404 Page 16 of43 &[DATE] SH ELL-MCCLU RG-052807 A UCHSC Subcontracts Fudan University " Actual expense IPHSC Actual expense SMCDCP Actual expense -"'- EMBSI Actual expense Children's Hospital Cincinnati !. Actual expense TOTALS 1'1 Actual expense ~ LT 8/6/04 1::1 BJ 8125/04 Benzene Health Research Consortium UCHSC Subcontract 3Q04 Financial Report B 2001 1st-4thQtr. 2001 "Total subcontractor expenses" from study report (preliminary figure); "actual expenses" from UC Office of Grants & Contracts spreadsheet (final figures). C 2002 1st-4thQtr. D 1st&2nd Qtr. EI 2003 F 3rd & 4th Qtr. GI H III J 2004 1st&2nd Qtr. 3rd & 4th Qtr. KI L 1M 2005 1st&2nd Qtr. 0 0 411,935 468,341 1,088,352 0 0 0 0 8,339 27,496 7,683 0 0 0 0 45,563 24,766 2,500 0 0 0 0 372,725 00 00 00 2002 $0 $1,025,372 7,298 2003 $845,860 45,267 $565,870 29,972 2004 $1,128,507 $1,128,507 0 $0 0 2005 $0 Page 17 of 43 &[DATE] SH ELL-MCCLU RG-052808 N 3rd & 4th Qtr. 01 P IQI R 2006 1st&2nd Qtr. 3rd & 4th Qtr. sl T IU 2007 1st&2nd Qtr. v 3rd & 4th Qtr. 40 0 0 0 0 00 00 0 00 00 0 -"'- 00 00 0 !. 0 14 $0 0 2006 $0 0 $0 0 2007 $0 0 $0 ~ W TOTALS 1,968,628 43,518 72,829 372,725 82,537 $2,540,237 1::1 Benzene Health Research Consortium UCHSC Subcontract 3Q04 Financial Report Page 18 of 43 &[DATE] SH ELL-MCCLU RG-052809 Benzene Health Research Consortium Irons Field Expenses 3Q04 Financial Report A IRONS T&E (X81 06) Cost Centers Payments .q Disbursed ~ Airfare & related expenses ~ Budgeted Actual expense CurrentVariance ~ Cumm Variance ~ Apartment I hotel & related expenses Budgeted Actual expense ~ CurrentVariance ~ Cumm Variance Other expenses e.g. taxi, limo, misc. Budgeted Actual expense ~ CurrentVariance I ::1 Cumm Variance L' ~ Budgeted Actual expense L.. CurrentVariance L."+ Cumm Variance ~ CUMULATIVE TOTALS ~ Budgeted L. Expense L., Variance riO- Blue: future cumulative variance has no meaning until Expense entered. ,,"+ LT 10120104 ~ BJ10121/04 B 2001 4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. E 3rd Qtr. $145,763 $1,280 $1,606 ($326) ($326) $1,280 $1,024 $256 $256 $640 $528 $112 $112 $393,723 $103,624 $75,179 $28,445 $28,119 $103,624 $89,717 $13,907 $14,163 $51,812 $30,653 $21,159 R,272 $0 $55,343 $27,359 $27,984 $56,103 $55,343 $45,291 $10,052 $24,216 $27,672 $16,926 $10,746 $32017 $0 $27,672 $25,079 $2,593 $58,696 $27,672 $21,200 $6,472 $30,687 $13,836 $8,103 $47,240 $79,257 2001 $3,200 $3,157 $43 $43 $3,200 $3,157 $43 $259,060 $195,549 $63,511 $63,554 2002 $262,260 $198,706 $63,554 $138,359 $89,577 $48,782 $112,336 $400,619 $288,283 $112,336 $69,179 $54,382 $14,797 $127,133 $469,798 $342,665 $127,133 "Actual expense" is from quarterly expense reports, and does not reflect contract prepayments Amt paid to Irons to date: Amt Irons has spent: Amt. In Irons bank acct: $728,806 numbers as of 06130104 $651,624 $77,182 Page 19 of43 &[DATE] SHELL-MCCLURG-052810 "I 2 ~ ~ ~ ~ ~ 2003 F 4thQtr. ~,::I L' -. L L"I ~ ~ L L, 2003 L 4Q03 ADJUSTMENT - 200112002 expense underrecorded; +$114,289 adjustment .)U ~ ~ .).) ,)"1 ~ ~ ~ ~ "I Benzene Health Research Consortium Irons Field Expenses 3Q04 Financial Report G 1stQtr. HI 2004 2nd Qtr. 3rd Qtr. J 4thQtr. $0 $0 $189,320 $0 $0 $22,200 $74,850 ($52,650) $6,046 $22,205 $81,131 ($58,926) ($28,239) $11,103 $13,625 ($2,522) $76735 $22,200 $18,124 $4,076 $10,122 $22,205 $20,041 $2,164 ($26,075) $11,103 $5,780 $5,323 $82058 $22,200 $32,651 ($10,451) ($329) $22,205 $55,100 ($32,895) ($58,970) $11,103 $7,658 $3,445 $85,503 $22,200 $0 $22,200 $21,871 $22,205 $0 $22,205 ($36,765) $11,103 $0 $11,103 $96606 $22,200 $0 $22,200 $44,071 $22,205 $0 $22,205 ($14,560) $11,103 $0 $11,103 $107,709 $55,508 $169,606 ($114,098) $13,035 $55,508 $43,945 $11,563 $24,598 $525,306 $512,270 $13,035 $580,814 $556,215 $24,598 $55,508 $55,508 $95,409 $0 ($39,901) $55,508 ($15,303) $40,205 2004 $636,322 $691,830 $651,624 $651,624 ($15,303) $40,205 $55,508 $0 $55,508 $95,713 $747,338 $651,624 $95,713 K 1stQtr. $0 $22,200 $0 $22,200 $66,271 $22,205 $0 $22,205 $7,645 $11,103 $0 $11,103 $118,812 $55,508 $0 $55,508 $151,221 $802,846 $651,624 $151,221 LM 2005 2nd Qtr. 3rd Qtr. $0 $0 $22,200 $0 $22,200 $88,471 $22,205 $0 $22,205 $29,850 $11,103 $0 $11,103 $129,915 $22,200 $0 $22,200 $110,671 $22,205 $0 $22,205 $52,055 $11,103 $0 $11,103 $141,018 $55,508 $55,508 $0 $0 $55,508 $55,508 $206,729 $262,237 2005 $858,354 $913,862 $651,624 $651,624 $206,729 $262,237 N 4thQtr. $0 $22,200 $0 $22,200 $132,871 $22,205 $0 $22,205 $74,260 $11,103 $0 $11,103 $152,121 $55,508 $0 $55,508 $317,745 $969,370 $651,624 $317,745 0 1stQtr. $0 $22,200 $0 $22,200 $155,071 $22,205 $0 $22,205 $96,465 $11,103 $0 $11,103 $163,224 $55,508 $0 $55,508 $373,253 $1,024,878 $651,624 $373,253 P 2006 2nd Qtr. Q 3rd Qtr. R 4thQtr. $0 $0 $0 $22,200 $0 $22,200 $177,271 $22,205 $0 $22,205 $118,670 $11,103 $0 $11,103 $174327 $22,200 $0 $22,200 $199,471 $22,205 $0 $22,205 $140,875 $11,102 $0 $11,102 $185429 $22,200 $0 $22,200 $221,671 $22,205 $0 $22,205 $163,080 $11,102 $0 $11,102 $196,531 $55,508 $55,507 $0 $0 $55,508 $55,507 $428,761 $484,268 2006 $1,080,386 $1,135,893 $651,624 $651,624 $428,761 $484,268 $55,507 $0 $55,507 $539,775 $1,191,400 $651,624 $539,775 S 1stQtr. TU 2007 2nd Qtr. 3rd Qtr. V 4thQtr. $0 $0 $0 $0 $22,200 $0 $22,200 $243,871 $22,205 $0 $22,205 $185,285 $11,102 $0 $11,102 $207,633 $22,200 $0 $22,200 $266,071 $22,205 $0 $22,205 $207,490 $11,102 $0 $11,102 $218,735 $22,200 $0 $22,200 $288,271 $22,205 $0 $22,205 $229,695 $11,102 $0 $11,102 $229,837 $22,200 $0 $22,200 $310,471 $22,205 $0 $22,205 $251,900 $11,102 $0 $11,102 $240,939 $55,507 $0 $55,507 $595,282 $1,246,907 $651,624 $595,282 $55,507 $55,507 $0 $0 $55,507 $55,507 $650,789 $706,296 2007 $1,302,414 $1,357,921 $651,624 $651,624 $650,789 $706,296 $55,507 $0 $55,507 $761,803 $1,413,428 $651,624 $761,803 7 Page 20 of43 &[DATE] SHELL-MCCLURG-052811 W TOTALS "I 2 ~ ~ ~ ~ ~ ~,::I L' -. L L"I ~ ~ L L' L .)U ~ ~ .).) ,)"1 ~ ~ ~ ~ "I $565,319 $254,848 $221,671 $310,471 $565,404 $313,504 $163,080 $251,900 $282,705 $83,273 $196,531 $199,432 $1,413,428 $651,624 $539,775 $761,803 $1,413,428 $651,624 $761,803 Benzene Health Research Consortium Irons Field Expenses 3Q04 Financial Report Page 21 of43 &[DATE] SH ELL-MCCLU RG-OS2812 Benzene Health Research Consortium AHS 3Q04 Financial Report A "I .2 ~ ~ ~ ~ ~ ~ L' -. L L"I ~ '<0 Labor Budgeted Actual expense Current Variance Cumm Variance Travel & expenses Budgeted Actual expense Current Variance Cumm Variance Other direct expenses Budgeted Actual expense Current Variance Cumm Variance Budgeted Actual expense Current Variance Cumm Variance Budgeted Expense Variance AHS (X81 07) Cost Centers TOTALS CUMULATIVE TOTALS ~ ~ L .)U Blue: future cumulative variance has no meaning until Expense entered. LT10/18/04 BJ 10121/04 B 2001 4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. E 3rd Qtr. 2003 F 4thQtr. $84,025 $134,134 ($50,109) ($50,109) $290,013 $394,505 ($104,492) ($154,601) $157,756 $124,124 $33,632 ($120,970) $78,878 $137,280 ($58,402) ($179,372) $78,878 $73,690 $5,188 ($174,184) $0 $2,118 ($2,118) ($2,118) $140,000 $39,458 $100,542 $98,424 $57,000 $16,541 $40,459 $138,883 $28,500 $12,109 $16,391 $155,274 $28,500 $16,413 $12,087 $167,361 $0 $77 ($77) $77 2001 $84,025 $136,329 ($52,304) ($52,304) 2001 $84,025 $136,329 ($52,304) $5,500 $1,443 $4,057 $3980 200; $435,513 $435,406 $107 ($52,197) 2002 $519,538 $571,735 ($52,197) $1,500 $0 $1,500 $5480 $216,256 $140,665 $75,591 $23,394 $735,794 $712,400 $23,394 $750 $0 $750 $6230 $108,128 $149,389 ($41,261) ($17,868) $843,921 $861,789 ($17,868) 2003 2003 4Q03 Adjustment: expense reduced by $52,634; transferred to contingency since these were pre-consortia expenses $750 $0 $750 $6980 $108,128 $90,103 $18,025 $157 $952,049 $951,892 $157 G 1stQtr. HI 2004 2nd Qtr. 3rd Qtr. $72,090 $0 $72,090 ($102,094) $72,090 $149,980 ($77,890) ($179,984) $72,090 $92,201 ($20,111) ($200,094) $25,500 $0 $25,500 $192,861 $25,500 $18,534 $6,966 $199,827 $25,500 $12,522 $12,978 $212,805 $750 $0 $750 $7730 $98,340 $0 $98,340 $98,497 $1,050,389 $951,892 $98,497 $750 $109 $641 $8371 $750 $785 ($35) $8,336 10. $98,340 $98,340 $168,623 $105,508 ($70,283) ($7,168) $28,215 $21,047 2004 $1,148,730 $1,247,070 $1,120,515 $1,226,023 $28,215 $21,047 J 4thQtr. $72,090 $0 $72,090 ($128,004) $25,500 $0 $25,500 $238,305 $750 $0 $750 $9,086 $98,340 $0 $98,340 $119,387 $1,345,410 $1,226,023 $119,387 K 1stQtr. $84,217 $0 $84,217 ($43,787) $25,500 $0 $25,500 $263,805 $750 $0 $750 $9,836 $110,467 $0 $110,467 $229,854 $1,455,877 $1,226,023 $229,854 Page 22 of43 &[DATE] SHELL-MCCLURG-052813 Benzene Health Research Consortium AHS 3Q04 Financial Report "I .2 ~ ~ ~ ~ ~ ~ L' -. L L"I ~ '<0 ~ ~ L .)U LM 2005 2nd Qtr. 3rd Qtr. $84,217 $0 $84,217 $40,430 $84,217 $0 $84,217 $124,646 $25,500 $0 $25,500 $289,305 $25,500 $0 $25,500 $314,805 $750 $0 $750 $10,586 $750 $0 $750 $1 336 '05 $110,467 $110,467 $0 $0 $110,467 $110,467 $340,321 $450,787 2005 $1,566,344 $1,676,810 $1,226,023 $1,226,023 $340,321 $450,787 N 4thQtr. $84,217 $0 $84,217 $208,863 $25,500 $0 $25,500 $340,305 $750 $0 $750 $12086 $110,467 $0 $110,467 $561,254 $1,787,277 $1,226,023 $561,254 0 1stQtr. $76,746 $0 $76,746 $285,609 $35,000 $0 $35,000 $375,305 $750 $0 $750 $12,836 $112,496 $0 $112,496 $673,750 $1,899,773 $1,226,023 $673,750 PQ 2006 2nd Qtr. 3rd Qtr. $76,746 $0 $76,746 $362,356 $76,746 $0 $76,746 $439,102 $35,000 $0 $35,000 $410,305 $35,000 $0 $35,000 $445,305 $750 $750 $0 $750 $13,586 $0 $750 $14,336 10. $112,496 $112,496 $0 $0 $112,496 $112,496 $786,247 $898,743 2006 $2,012,270 $2,124,766 $1,226,023 $1,226,023 $786,247 $898,743 R 4thQtr. $76,746 $0 $76,746 $515,848 $35,000 $0 $35,000 $480,305 $750 $0 $750 $15,086 $112,496 $0 $112,496 $1,011,239 $2,237,262 $1,226,023 $1,011,239 S 1stQtr. $10,033 $0 $10,033 $525,881 $32,000 $0 $32,000 $512,305 $3,800 $0 $3800 $18,886 $45,833 $0 $45,833 $1,057,072 $2,283,095 $1,226,023 $1,057,072 T 2nd Qtr. 2007 U 3rd Qtr. $0 $0 $0 $525,881 $0 $0 $0 $512,305 $0 $0 $0 $18,886 $0 $0 $0 $525,881 $0 $0 $0 $512,305 $0 $0 $0 $18,886 $0 $0 $0 $0 $0 $0 $1,057,072 $1,057,072 2007 $2,283,095 $2,283,095 $1,226,023 $1,226,023 $1,057,072 $1,057,072 V 4thQtr. $0 $0 $0 $525,881 $0 $0 $0 $512,305 $0 $0 $0 $18,886 $0 $0 $0 $1,057,072 $2,283,095 $1,226,023 $1,057,072 W TOTALS $1,631,795 $1,105,914 $0 $525,881 $630,000 $117,695 $0 $512,305 $21,300 $2,414 $0 $18,886 $2,283,095 $1,226,023 $0 $1,057,072 $2,283,095 $1,226,023 $1,057,072 Page 23 of43 &[DATE] SH ELL-MCCLU RG-OS2814 Benzene Health Research Consortium Fudan 3Q04 Financial Report A FUDAN Cost Centers Labor (salary + benefits) "I Budgeted 2 Actual expense ~ Current Variance Cumm Variance Expenses J:L ~ Budgeted Actual expense Current Variance IL Cumm Variance ~ Overhead (15%) ~ Budgeted Actual expense Current Variance Cumm Variance ~ LI Budgeted Actual expense TOTALS -. Current Variance Cumm Variance CUMULATIVE TOTALS L"I ~ '<0 Budgeted Expense Variance ~ Blue: future cumulative variance has no meaning until Expense entered. ~ LT 10120104 "L BJ 10121/04 B 2001 $9,620 $0 $9,620 $9,620 $17,600 $0 $17,600 $17,600 $4,083 $0 $4083 $4083 2001 $31,303 $0 $31,303 $31,303 2001 $31,303 $0 $31,303 C 2002 D 1Q12Q03 E 2003 3003 F 4Q03 $8,775 $8,774 $1 $9,621 $4,388 $6,492 ($2,105) $7,516 $2,194 $0 $2,194 $9,709 $1,548 $0 $1,548 $11,257 $28,400 $4,870 $23,530 $41,130 $14,200 $0 $14,200 $55,330 $7,100 $8,851 ($1,751) $53,579 $4,645 $1,168 $3,477 $57,056 $5,576 $1,825 $3,751 $7834 200; $42,751 $15,470 $27,281 $58,584 2002 $74,054 $15,470 $58,584 $2,788 $0 $2,788 $10622 $21,376 $6,492 $14,883 $73,467 $95,430 $21,962 $73,467 $1,394 $0 $1,394 $12016 2003 $10,688 $8,851 $1,837 $75,305 2003 $106,117 $30,813 $75,305 $1,095 $0 $1,095 $13111 $7,288 $1,168 $6,120 $81,425 $113,405 $31,981 $81,425 G 1Q04 $1,548 $0 $1,548 $12,805 $4,645 $0 $4,645 $61,701 $1,095 $0 $1,095 $14,206 $7,288 $0 $7,288 $88,713 $120,693 $31,981 $88,713 HI 2004 2Q04 3Q04 $1,548 $14,385 ($12,837) ($32) $1,548 $0 $1,548 $1,516 $4,645 $9,750 ($5,105) $56,596 $4,645 $0 $4,645 $61,241 $1,095 $3,620 ($2525) $11681 $1,095 $0 $1,095 $12776 200. $7,288 $7,288 $27,755 $0 ($20,467) $7,288 $68,246 $75,534 2004 $127,981 $135,269 $59,736 $59,736 $68,246 $75,534 J 4Q04 $1,548 $0 $1,548 $3,064 $4,645 $0 $4,645 $65,886 $1,094 $0 $1094 $13870 $7,287 $0 $7,287 $82,821 $142,556 $59,736 $82,821 K 1Q05 LM 2005 2Q05 3005 N 4Q05 0 1Q06 $1,548 $0 $1,548 $4,612 $1,548 $0 $1,548 $6,160 $1,548 $0 $1,548 $7,708 $1,548 $0 $1,548 $9,256 $1,548 $0 $1,548 $10,804 $4,645 $0 $4,645 $70,531 $4,645 $0 $4,645 $75,176 $4,645 $0 $4,645 $79,821 $4,645 $0 $4,645 $84,466 $4,645 $0 $4,645 $89,111 $1,094 $0 $1,094 $14,964 $7,287 $0 $7,287 $90,108 $149,843 $59,736 $90,108 $1,094 $0 $1,094 $16,058 $1,094 $0 $1,094 $1 152 05 $7,287 $7,287 $0 $0 $7,287 $7,287 $97,395 $104,682 2005 $157,130 $164,417 $59,736 $59,736 $97,395 $104,682 $1,094 $0 $1,094 $18246 $1,094 $0 $1,094 $19340 $7,287 $0 $7,287 $111,969 $7,287 $0 $7,287 $119,256 $171,704 $59,736 $111,969 $178,991 $59,736 $119,256 Note: budget is in 2001 $. P 2006 2Q06 $1,548 $0 $1,548 $12,352 $4,645 $0 $4,645 $93,756 $1,094 $0 $1,094 $20,434 200. $7,287 $0 $7,287 $126,543 2006 $186,278 $59,736 $126,543 QR 3006 $1,548 $0 $1,548 $13,900 $4,645 $0 $4,645 $98,401 $1,094 $0 $1,094 $21,528 4Q06 $1,548 $0 $1,548 $15,448 $4,645 $0 $4,645 $103,046 $1,094 $0 ~094 622 $7,287 $0 $7,287 $133,830 $193,565 $59,736 $133,830 $7,287 $0 $7,287 $141,117 $200,852 $59,736 $141,117 S 1Q07 $1,548 $0 $1,548 $16,996 $4,645 $0 $4,645 $107,691 $1,094 $0 $1,094 $23,716 $7,287 $0 $7,287 $148,404 $208,139 $59,736 $148,404 Page 24 of43 &[DATE] SHELL-MCCLURG-052815 "I 2 ~ J:L ~ IL ~ ~ ~ LI -. L"I ~ '<0 ~ ~ "L TU 2007 2Q07 3007 $1,548 $0 $1,548 $18,544 $1,548 $0 $1,548 $20,092 $4,645 $0 $4,645 $112,336 $4,645 $0 $4,645 $116,981 $1,094 $0 $1,094 $24,810 $1,094 $0 $1,094 $25,904 2007 $7,287 $7,287 $0 $0 $7,287 $7,287 $155,691 $162,978 2007 $215,426 $222,713 $59,736 $59,736 $155,691 $162,978 V 4Q07 $1,548 $0 $1,548 $21,640 $4,645 $0 $4,645 $121,626 $1,094 $0 $1,094 $26,998 $7,287 $0 $7,287 $170,265 $230,000 $59,736 $170,265 W TOTALS $51,292 $29,652 $1,548 $21,640 $146,265 $24,639 $4,645 $121,626 $32,443 $5,445 $1,094 $26,998 $230,000 $59,736 $7,287 $170,265 $230,000 $59,736 $170,265 Benzene Health Research Consortium Fudan 3Q04 Financial Report Page 25 of43 &[DATE] SH ELL-MCCLU RG-052816 A SRP + ERP (X8109) Cost Centers Albertini Budgeted Actual expense CurrentVanance ~ ~ CummVanance Brody (DB5200X1503, resigned 4003) Budgeted Actual expense CurrentVanance I L Cumm Vanance Checkoway '" Budgeted Actual expense 1::1 L. CurrentVanance CummVanance Cherrie/lOM Budgeted Actual expense CurrentVanance CummVanance Greim Budgeted Actual expense L. CurrentVanance CummVanance ~Herrick ~ ")l. Budgeted Actual expense )L ~ ..)"+ CurrentVanance Cumm Vanance Idanpaan-Heikkila Budgeted ..):: Actual expense ~ CurrentVanance ~ Cumm Vanance ")C Larson ..)t1 Budgeted ~ Actual expense ~ CurrentVanance "+. CummVanance "+.: Li ~ Budgeted ~ Actual expense "+1: CurrentVanance ,,+, CummVanance ~Minden/OntarioCancerlnstitute ~ ::>l. Budgeted Actual expense CurrentVanance )L Cumm Vanance ~ Mueller (resigned 2003) ::>"+ Budgeted ::>:: ~ Actual expense CurrentVanance ~ Cumm Vanance ::>C Rice ::>t1 ~ Budgeted Actual expense ~ CurrentVanance CummVanance 0': Rockette ~ Budgeted ~ 01: Actual expense CurrentVanance CummVanance ~ Budgeted Actual expense CurrentVanance , L Cumm Vanance Clayton (joined 2004) '" Budgeted Actual expense CurrentVanance CummVanance Lombardo (joined 2004) Budgeted Actual expense CurrentVanance OL. CummVanance O~ TOTALS Budgeted Actual expense OC CurrentVanance CummulatlveVanance CUMULATIVE TOTALS Budgeted Expense Vanance B 2001 4thOtr c 2002 1st-4thOtr DIE I F 2003 1st&2ndOtr 3rdOtr 4thOtr Benzene Health Research Consortium SRP + ERP 3Q04 Financial Report G 1stOtr IHI I J 2004 2ndOtr 3rdOtr 4thOtr K 1stOtr I LIM 2005 2ndOtr 3rdOtr N 4thOtr o 1stOtr I PIQ 2006 2ndOtr 3rdOtr R 4thOtr SIT I U 2007 1stOtr 2ndOtr 3rdOtr v 4thOtr w TOTALS $2,160 $2,000 $160 $160 $8,640 $0 $8,640 $8,800 $4,320 $0 $4,320 $13,120 $2,160 $0 $2,160 $15,280 $322 $2,529 ($2,207) $13,073 ($13,073) $0 ($13,073) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $13,000 $17,529 $4,529 $3,000 $13,000 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $0 $4,320 $15,120 $2,160 $0 $2,160 $17,280 $322 $0 $322 $17,602 ($17,602) $0 ($17,602) $0 $0 $1,500 ($1,500) ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $0 $0 ($1,500) $0 $1,500 $0 $0 $2,160 $1,000 $1,160 $1,160 $8,640 $0 $8,640 $9,800 $4,320 $0 $4,320 $14,120 $2,160 $2,422 ($262) 1.858 $322 $0 $322 $14,180 ($14,180) $0 ($14,180) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $13,000 $16,422 $3,422 $3,000 $13,000 $2,160 $0 $2,160 $2,160 $8,640 $2,122 $6511 $8,678 $4,320 $0 $4,320 $12,998 $2,160 $0 $2,160 115.158 $322 $0 $322 $15,480 ($15,480) $0 ($15,480) ($0) $0 $7,029 ($7,029) ($7,029) $250 $0 $250 ($6,779) $8,000 $0 $8,000 $1,221 $0 $0 $0 $1,221 $0 $0 $0 $1,221 $250 $0 $250 $1,471 $8,000 $0 $8,000 $9,471 $0 $0 $0 $9,471 $0 $0 $0 $9,471 $250 $0 $250 $9,721 $6,000 $0 $6,000 $15,721 $0 $0 $0 $15,721 $0 $0 $0 $15,721 $250 $0 $250 $15,971 $2,000 $0 $2,000 $17,971 $27,122 $9,151 $2,000 $17,971 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $0 $4,320 $15,120 $2,160 $0 $2,160 $17,280 $322 $7,334 ($7,012) $10,268 ($10,268) $0 ($10,268) $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $250 $6,000 $0 $0 $250 $2,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $250 $6,000 $0 $0 $250 $2,000 $0 $250 $8,250 $8,250 $8,250 $8,500 $16,500 $16,500 $16,500 $16,750 $22,750 $22,750 $22,750 $23,000 $25,000 $32,334 $7,334 $2,000 $25,000 $2,160 $2,000 $160 $160 $8,640 $0 $8,640 $8,800 $4,320 $0 $4,320 $13,120 $2,160 $0 $2,160 $15,280 $322 $4,454 ($4,132) $11,148 ($11,148) $0 ($11,148) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $12,000 $18,454 $6,454 $2,000 $12,000 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $4,344 ($24) $10,776 $2,160 $180 $1,980 $12,756 $322 $0 $322 $13,078 ($13,078) $0 ($13,078) $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $0 $250 $8,000 $0 $250 $8,250 $8,250 $8,250 $8,500 $16,500 $16,500 $16,500 $16,750 $24,750 $24,750 $24,750 $25,000 $33,000 $37,524 $4,524 $8,000 $33,000 $2,160 $2,127 $3 $3 $8,640 $0 $8,640 $8,673 $4,320 $0 $4,320 $12,993 $2,160 $2,636 ($476) $12,517 $322 $0 $322 $12,839 ($12,839) $0 ($12,839) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $12,000 $16,763 $4,763 $2,000 $12,000 $2,160 $6,796 ($4,636) ($4,636) $8,640 $3,000 $5,640 $1,004 $4,320 $0 $4,320 $5,324 $2,160 $0 $2,160 $7,484 $322 $13,094 ($12,772) ($5,288) $5,288 $0 $5,288 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $4,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $4,000 $0 $250 $10,250 $10,250 $10,250 $10,500 $20,500 $20,500 $20,500 $20,750 $30,750 $30,750 $30,750 $31,000 $35,000 $57,890 $22,890 $4,000 $35,000 $2,160 $1,000 $1,160 $1,160 $8,640 $0 $8,640 $9,800 $4,320 $0 $4,320 $14,120 $2,160 $0 $2,160 $16,280 $322 $0 $322 $16,602 ($16,602) $0 ($16,602) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $12,000 $13,000 $1,000 $2,000 $12,000 $2,160 $8,640 $4,320 $2,160 $322 ($16,352) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $1,250 $1,250 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $1,250 $910 $8,640 $4,320 $2,160 $322 ($16,352) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $910 $9,550 $13,870 $16,030 $16,352 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $4,000 $320 $11,120 $2,160 $5,692 ($3,532) $7,588 $322 $2,000 ($1,678) $5,910 ($5,410) $500 ($5,910) ($0) $3,000 $3,500 ($500) ($500) $1,500 $2,500 ($1,000) ($1,500) $4,000 $0 $4,000 $2,500 $1,500 $0 $1,500 $4,000 $1,000 $0 $1,000 $5,000 $1,500 $0 $1,500 $6,500 $4,000 $0 $4,000 $10,500 $1,000 $0 $1,000 $11,500 $1,000 $0 $1,000 $12,500 $1,000 $0 $1,000 $13,500 $4,000 $0 $4,000 $17,500 $1,000 $0 $1,000 $18,500 $1,000 $0 $1,000 $19,500 $1,000 $0 $1,000 $20,500 $3,000 $0 $3,000 $23,500 $41,692 $18,192 $3,000 $23,500 $2,160 $0 $2,160 $2,160 $8,640 $0 $8,640 $10,800 $4,320 $0 $4,320 $15,120 $2,160 $0 $2,160 $17,280 $322 $2,670 ($2,348) $14,932 ($14,932) $0 ($14,932) $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $2,000 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $12,000 $14,670 $2,670 $2,000 $12,000 $2,160 $2,500 ($340) ($340) $8,640 $0 $8,640 $8,300 $4,320 $1,650 $2,670 $10,970 $2,160 $6,054 ($3,894) $7,076 $322 $0 $322 $7,398 ($7,398) $0 ($7,398) $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $2,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $10,000 $0 $0 $250 $2,000 $0 $250 $10,250 $10,250 $10,250 $10,500 $20,500 $20,500 $20,500 $20,750 $30,750 $30,750 $30,750 $31,000 $33,000 $43,204 $10,204 $2,000 $33,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $13,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $0 $0 $250 $3,000 $3,000 $0 $0 $250 $3,250 $3,250 $3,250 $3,500 $6,500 $6,500 $6,500 $6,750 $9,750 $9,750 $9,750 $10,000 $13,000 $13,000 $0 $0 $0 $0 2001 $30,240 $18,673 $11,567 $11,567 2001 $30,240 $18,673 $11,567 $0 $0 $0 $0 2002 $120,960 $5,122 $115838 $127,405 2002 $151,200 $23,795 $127,405 $0 $0 $0 $0 $60,480 $9,994 $50,486 $177,891 $211,680 $33,789 $177,891 $0 $0 $0 $0 2003 $30,240 $16,984 $13,256 $191,147 2003 $241,920 $50,773 $191,147 $0 $0 $0 $0 $4,508 $32,081 ($27,573) $163,574 $246,428 $82,854 $163,574 $0 $0 $0 $0 ($163,074) $500 ($163,574) $0 $83,354 $83,354 ($0) $0 $250 $0 $0 $0 $250 $0 $250 2004 $3,000 $12,029 ($9,029) ($9,029) 2004 $86,354 $95,38: ($9,029) $4,750 $2,500 $2,250 ($6,779) $91,104 $97,883 ($6,779) $3,000 $0 $3,000 $3,250 $72,000 $0 $72,000 $65,222 $163,104 $97,883 $65,221 $0 $0 $0 $3,250 $1,500 $0 $1,500 $66,722 $164,604 $97,883 $66,721 $0 $0 $0 $3,250 $250 $0 $250 $3,500 2005 $1,000 $4,750 $0 $0 $1,000 $4,750 $67,722 $72,472 2005 $165,604 $170,354 $97,883 $97,883 $67,721 $72,471 $3,000 $0 $3,000 $6,500 $72,000 $0 $72,000 $144,472 $242,354 $97,883 $144,471 $0 $0 $0 $6,500 $1,000 $0 $1,000 $145,472 $243,354 $97,883 $145,471 $0 $0 $0 $6,500 $250 $0 $250 $6,750 2006 $1,000 $0 $1,000 $146,472 2006 $244,354 $97,883 $146,471 $4,250 $0 $4,250 $150,722 $248,604 $97,883 $150,721 $3,000 $0 $3,000 $9,750 $68,000 $0 $68,000 $218,722 $316,604 $97,883 $218,721 $0 $0 $0 $9,750 $1,000 $0 $1,000 $219,722 $317,604 $97,883 $219,721 $0 $0 $0 $9,750 $250 $0 $250 $10,000 2007 $1,000 $4,250 $0 $0 $1,000 $4,250 $220,722 $224,972 2007 $318,604 $322,854 $97,883 $97,883 $220,721 $224,971 $3,146 $0 $3,146 $13,146 $41,146 $0 $41,146 $266,118 $364,000 $97,883 $266,117 $13,146 $0 $3,146 $13.146 $364,000 $97,883 $41,146 $266,118 $364,000 $97,883 $266,117 .,,",'Tll SH ELL-MCCLU RG-OS2817 A IBI c I D I E -"'" ""::I~ ::It Blue fulure cumulallvevanance has no meaning unlll Expense enlered LT10/20/04 BJ 10/21/04 Benzene Health Research Consortium SRP + ERP 3Q04 Financial Report F G IHI I I J I K L M N 0 1Q04 budget ajustments 10 zero ourvanancelo develop more usefuI 1:~2d,i:~lmeetmq C c" ChangeapprovedbyOCal P Q RS T UV W Page 27 of43 &[DATE] SHELL-MCCLURG-052818 Benzene Health Research Consortium Communications 3Q04 Financial Report ~ ~ APCO "I Budgeted Actual expense CurrentVariance Cumm Variance Travel ~ Budgeted Actual expense CurrentVariance Cumm Variance Other L<L Budgeted ~ Actual expense CurrentVariance Cumm Variance A COMMUNICATIONS Cost Centers BC D 2001 2002 lst- 4th OtL lst- 4th OtL 1st & 2nd OtL E 2003 3rd OtL F 4th OtL" G lstOtL HI 2004 2nd OtL 3rd OtL $57,600 $0 $57,600 $57,600 $230,400 $232,229 ($1,829) $55,771 $120,000 $14,483 $105,517 $161,288 $60,000 $7,351 $52,649 $213,937 ($187,396) $26,541 ($213,937) ($0) $14,401 $0 $14,401 $14,401 $14,400 $790 $13,610 $28,011 $14,400 $1,235 $13,165 $41,176 $1,800 $0 $1,800 $1,800 $7,200 $7,091 $109 $1,909 $3,750 $0 $3,750 $5,659 $1,875 $526 $1,349 $7,008 ($5,876) $1,132 ($7,008) $0 $450 $0 $450 $450 $450 $0 $450 $900 $450 $0 $450 $1,350 $600 $0 $600 $600 $2,400 $1,417 $983 $1,583 $1,250 $80 $1,170 $2753 $625 $0 $625 $3378 ($3,364) $15 ($3,379) $2 $150 $0 $150 $148 $150 $0 $150 $298 $150 $0 $150 $448 J 4th OtL $14,400 $0 $14,400 $55,576 $450 $0 $450 $1,800 $150 $0 $150 $598 K lstOtL L 2 2nd OtL $14,400 $0 $14,400 $69,976 $14,400 $0 $14,400 $84,376 $450 $0 $450 $2,250 $450 $0 $450 $2,700 $150 $0 $150 $748 $150 $0 $150 $898 G:L '[ ~ ~ ~"I L~ ~ Budgeted Actual expense CurrentVariance Cumm Variance Budgeted Actual expense CurrentVariance Cumm Variance $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 L~ Budgeted ~ Actual expense ~ CurrentVariance Cumm Variance .)~ ~ ~ .)t Budgeted Actual expense CurrentVariance ;j, Cumm Variance ~ ~ "I~ 4' Budgeted Actual expense CurrentVariance TOTALS ~ Cumm Variance ~ CUMULATIVE TOTALS "1"1 Budgeted 4~ Expense "10 Variance "I, - Telecommunications, Consulting Services, Duplicating/Copies Internal, Postage, Couriers, Telephone, Meals, Lexis Nexis Searches ~ Blue: future cumulative variance has no meaning until Expense entered. ~ "- Budget adjustment reflects budget reduction from $1 MM to $550k :)~ o LT 7/19/04 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2001 $60,000 $0 $60,000 $60,000 2001 $60,000 $0 $60,000 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2002 $240,000 $240,738 ($738) $59,262 2002 $300,000 $240,738 $59,262 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $125,000 $14,564 $110,436 $169,699 $425,000 $255,301 $169,699 $0.00 $0.00 $0.00 $0.00 2003 $62,500 $7,877 $54,623 $224,322 2003 $487,500 $263,178 $224,322 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 ($196,636) $27,688 ($224,324) ($2) $15,001 $0 $15,001 $14,999 $290,864 $290,866 ($2) $305,865 $290,866 $14,999 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2004 $15,000 $15,000 $790 $1,235 $14,210 $13,765 $29,209 $42,974 2004 $320,865 $335,865 $291,656 $292,891 $29,209 $42,974 $0.00 $0.00 $0.00 $0.00 $15,000 $0 $15,000 $57,974 $350,865 $292,891 $57,974 $0.00 $0.00 $0.00 $0.00 $15,000 $0 $15,000 $72,974 $365,865 $292,891 $72,974 $0.00 $0.00 $0.00 $0.00 2 $15,000 $0 $15,000 $87,974 2 $380,865 $292,891 $87,974 Page 28 of43 &[DATE] SHELL-MCCLURG-052819 Benzene Health Research Consortium Communications 3Q04 Financial Report M 5 ~ 3rd Olr ~ "I $14,400 $0 $14,400 $98,776 N 4lh Olr $14,400 $0 $14,400 $113,176 0 1sl0lr $14,400 $0 $14,400 $127,576 PQ 2006 2nd Olr 3rd Olr $14,400 $0 $14,400 $141,976 $14,400 $0 $14,400 $156,376 R 4lh Olr" $14,400 $0 $14,400 $170,776 S 1sl0lr $18,865 $0 $18,865 $189,641 TU 2007 2nd Olr 3rd Olr $18,865 $0 $18,865 $208,506 $18,866 $0 $18,866 $227,372 V 4lh Olr $18,866 $0 $18,866 $246,238 ~ $450 $450 $450 $450 $450 $450 $689 $689 $689 $689 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $450 $450 $450 $450 $450 $450 $689 $689 $689 $689 $3,150 $3,600 $4,050 $4,500 $4,950 $5,400 $6,089 $6,778 $7,466 $8,155 L<L $150 $150 ~ $0 $0 $150 $150 $1,048 $1,198 $150 $0 $150 $1,348 $150 $0 $150 $1,498 $150 $0 $150 $1,648 $150 $0 $150 $1,798 $230 $0 $230 $2,028 $230 $0 $230 $2,257 $230 $0 $230 $2,487 $230 $0 $230 $2,717 G:L '[ ~ ~ ~"I L~ ~ $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 L~ $0.00 ~ $0.00 ~ $0.00 $0.00 .)~ ~ ~ .)t $0.00 $0.00 $0.00 ;j, $0.00 ~5 ~ $15,000 "I~ $0 4' $15,000 ~ $102,974 ~5 "1"1 $395,865 4~ $292,891 "10 $102,974 "I, ~ ~ :)~ o $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $15,000 $0 $15,000 $117,974 $410,865 $292,891 $117,974 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $15,000 $0 $15,000 $132,974 $425,865 $292,891 $132,974 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2006 $15,000 $15,000 $0 $0 $15,000 $15,000 $147,974 $162,974 2006 $440,865 $455,865 $292,891 $292,891 $147,974 $162,974 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $15,000 $0 $15,000 $177,974 $470,865 $292,891 $177,974 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $19,783 $0 $19,783 $197,757 $490,648 $292,891 $197,757 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2007 $19,783 $19,784 $0 $0 $19,783 $19,784 $217,541 $237,325 2007 $510,431 $530,216 $292,891 $292,891 $217,541 $237,325 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $19,784 $0 $19,784 $257,109 $550,000 $292,891 $257,109 W TOTALS $528,867 $282,629 $246,238 $246,238 $16,904 $8,749 $8,155 $8,155 $4,229 $1,513 $2,717 $2,717 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $550,000 $292,891 $177,974 $257,109 $550,000 $292,891 $257,109 Page 29 of43 &[DATE] SH ELL-MCCLU RG-052820 Benzene Health Research Consortium Legal 3Q04 Financial Report A LEGAL Cost Centers Steptoe &Johnson "I Budgeted .2 Actual expense ~ CurrentVariance Cumm Variance B 2001 1st-4thQtr. C 2002 1st-4thQtr. D 1st&2nd Qtr. $30,000 $0 $30,000 $30,000 $120,000 $13,565 $106,435 $136,435 $62,500 $1,728 $60,772 $197,207 ~ ~ Budgeted Expense Variance Blue: future cumulative variance has no 12 meaning until Expense entered. $30,000 $0 $30,000 $150,000 $13,565 $136,435 $212,500 $15,293 $197,207 * budget adjustment to lower program budget from $500K to $1 OOK, as approved 14 by DC on 11/11/03 12 ~ LT7/19/04 RT 7/1612004 E 2003 3rd Qtr. $31,250 $0 $31,250 $228,457 $243,750 $15,293 $228,457 F 4th Qtr.* G 1stQtr. HI 2004 2nd Qtr. 3rd Qtr. ($210,542) $17,915 ($228,457) $0 $4,175 $365 $3,810 $3,810 $4,175 $2,995 $1,180 $4990 $4,175 $1,870 $2,305 $7,294 $33,208 $33,208 $0 $37,383 $33,572 $3,810 $41,557 $36,567 $4,990 $45,732 $38,437 $7,294 J 4thQtr. $4,175 $0 $4,175 $11469 $49,906 $38,437 $11,469 K 1stQtr. LM 2005 2nd Qtr. 3rd Qtr. $4,175 $0 $4,175 $15,643 $4,175 $0 $4,175 $19,818 $4,175 $0 $4,175 $23,992 $54,081 $38,437 $15,643 $58,255 $38,437 $19,818 $62,430 $38,437 $23,992 N 4thQtr. $4,175 $0 $4,175 $28,167 $66,604 $38,437 $28,167 0 1stQtr. PQ 2006 2nd Qtr. 3rd Qtr. $4,175 $0 $4,175 $32341 $4,175 $0 $4,175 $36,516 $4,175 $0 $4,175 $40,690 $70,779 $38,437 $32,341 $74,953 $38,437 $36,516 $79,128 $38,437 $40,690 R 4thQtr. $4,175 $0 $4,175 $44,865 $83,302 $38,437 $44,865 S 1stQtr. TU 2007 2nd Qtr. 3rd Qtr. $4,175 $0 $4,175 $49039 $4,175 $0 $4,175 $53,214 $4,175 $0 $4,175 $57388 $87,477 $38,437 $49,039 $91,651 $38,437 $53,214 $95,826 $38,437 $57,388 V 4thQtr. $4,175 $0 $4,175 $61,563 $100,000 $38,437 $61,563 Page 30 of43 &[DATE] SHELL-MCCLURG-052821 W TOTALS L. --zt $100,000 0 $38,437 $61,563 $61,563 --g- $100,000 IU $38,437 $61,563 12 14 f5" 10 Benzene Health Research Consortium Legal 3Q04 Financial Report Page 31 of43 &[DATE] SH ELL-MCCLU RG-OS2822 Benzene Health Research Consortium QA-QC 3Q04 Financial Report A QA-QC ~ Cost Centers ~ Contractor "I Budgeted 0 Actual expense ~ CurrentVariance Cumm Variance Travel ~ Budgeted LlL Actual expense CurrentVariance Cumm Variance BC D 2001 2002 1st- 4th OtL 1st- 4th OtL 1st & 2nd OtL E 2003 3rd OtL F 4th OtL G 1stOtL HI 2004 2nd OtL 3rd OtL J 4th OtL K 1stOtL LM 2005 2nd OtL 3rd OtL N 4th OtL 0 1stOtL PQ 2006 2nd OtL 3rd OtL R 4th OtL S 1stOtL TU 2007 2nd OtL 3rd OtL V 4th OtL $13,500 $0 $13,500 $13,500 $54,000 $0 $54,000 $67,500 $28,126 $0 $28,126 $95,626 $14,063 $0 $14,063 $109,689 ($109,689) $0 ($109,689) $0 $6,250 $0 $6,250 $6,250 $6,250 $0 $6,250 $12,500 $6,250 $0 $6,250 $18,750 $6,250 $0 $6,250 $25,000 $6,250 $0 $6,250 $31,250 $6,250 $0 $6,250 $37,500 $6,250 $0 $6,250 $43,750 $6,250 $0 $6,250 $50,000 $6,250 $0 $6,250 $56,250 $6,250 $0 $6,250 $62,500 $6,250 $0 $6,250 $68,750 $6,250 $0 $6,250 $75,000 $6,250 $0 $6,250 $81,250 $6,250 $0 $6,250 $87,500 $6,250 $0 $6,250 $93,750 $6,250 $0 $6,250 $100,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 L<l Budgeted 12 Actual expense CurrentVariance Cumm Variance ~ ~ L' l. ~ ~ L"I Budgeted Actual expense CurrentVariance Cumm Variance Budgeted l.o ~ L, Actual expense CurrentVariance Cumm Variance l.~ Budgeted ~ ~ Actual expense CurrentVariance Cumm Variance ,).0 ~ ~ Budgeted Actual expense CurrentVariance ;j, Cumm Variance ~ ~ "IU 4' IAL Budgeted Actual expense CurrentVariance ~ Cumm Variance ~ CUMULATIVE TOTALS "1"1 Budgeted 40 Expense "10 Variance Dlue: u ure cumu a Ive variance has no meaning 47 until Expense entered. ~ $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 'UU' $13,500 $0 $13,500 $13,500 2001 $13,500 $0 $13,500 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 'UU, $54,000 $0 $54,000 $67,500 2002 $67,500 $0 $67,500 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $28,126 $0 $28,126 $95,626 $95,626 $0 $95,626 $0 $0 $0 $0 'UUO $14,063 $0 $14,063 $109,689 2003 $109,689 $0 $109,689 $0 $0 $0 $0 ($109,689) $0 ($109,689) $0 $0 $0 $0 $0 $0 $0 $0 $6,250 $0 $6,250 $6,250 $6,250 $0 $6,250 $0 $0 $0 $0 $0 $0 $0 $0 IU4 $6,250 $6,250 $0 $0 $6,250 $6,250 $12,500 $18,750 2004 $12,500 $18,750 $0 $0 $12,500 $18,750 $0 $0 $0 $0 $0 $0 $0 $0 $6,250 $0 $6,250 $25,000 $6,250 $0 $6,250 $31,250 $25,000 $31,250 $0 $0 $25,000 $31,250 $0 $0 $0 $0 $0 $0 $0 $0 " UO $6,250 $6,250 $0 $0 $6,250 $6,250 $37,500 $43,750 2005 $37,500 $43,750 $0 $0 $37,500 $43,750 $0 $0 $0 $0 $6,250 $0 $6,250 $50,000 $50,000 $0 $50,000 $0 $0 $0 $0 $6,250 $0 $6,250 $56,250 $56,250 $0 $56,250 $0 $0 $0 $0 $0 $0 $0 $0 UO $6,250 $6,250 $0 $0 $6,250 $6,250 $62,500 $68,750 2006 $62,500 $68,750 $0 $0 $62,500 $68,750 $0 $0 $0 $0 $6,250 $0 $6,250 $75,000 $75,000 $0 $75,000 $0 $0 $0 $0 $6,250 $0 $6,250 $81,250 $81,250 $0 $81,250 $0 $0 $0 $0 $0 $0 $0 $0 IUf $6,250 $6,250 $0 $0 $6,250 $6,250 $87,500 $93,750 2007 $87,500 $93,750 $0 $0 $87,500 $93,750 $0 $0 $0 $0 $6,250 $0 $6,250 $100,000 $100,000 $0 $100,000 * budget adjustment to lower program budget from $225K to $1 OOK, as 49 approved by DC on 11/11/03 ~ LT 7119104 Page 32 of43 &[DATE] SH ELL-MCCLU RG-052823 ~ ~ "I 0 ~ ~ LlL L<l 12 ~ ~ L' l. ~ ~ L"I l.o ~ L, l.~ ~ ~ ,).0 ~ ~ ;j, ~ ~ "IU 4' ~ ~ "1"1 40 "10 W TOTALS $100,000 $0 $100,000 $100,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $100,000 $0 $100,000 $100,000 $100,000 $0 $100,000 47 ~ 49 ~ Benzene Health Research Consortium QA-QC 3Q04 Financial Report Page 33 of43 &[DATE] SH ELL-MCCLU RG-OS2824 A API Cost Centers Salaries ~ Budgeted .2 Actual expense CurrentVariance Cumm Variance ~ Employee Benefits ~ Budgeted Actual expense CurrentVariance ~ Cumm Variance ~ Travel 1"1 Budgeted 10 Actual expense ~ CurrentVariance Cumm Variance Other Operating Expenses (& mtgs) I~ Budgeted ~ Actual expense -. CurrentVariance L. Cumm Variance L API Recovered Overhead ~ Budgeted ~ L' Actual expense CurrentVariance l. Cumm Variance ~ API Allocated Costs ~ ,)u Budgeted Actual expense ;j' CurrentVariance ~ Cumm Variance ~ Supported Expense ,)"1 Budgeted ;jo Actual expense ~ .", CurrentVariance Cumm Variance ;jts rALS ;j~ Budgeted ~ ~ ~ Actual expense CurrentVariance Cumm Variance 4;j CUMULATIVE TOTALS ~ ~ "It Budgeted Expense Variance "I, ~ LT 7/19/04 ~ RT 7/16/2004 :>u Assumptions: ~ Year 5, 6,7 Less than 1 FTE al/ocated, based al/ocated cost on 112 FTE ~ T&E and Other $15K for Annual Meeting (3rd Quarter) :>"1 Sup,:,orted Ex. ense dro off Jeft some funds for consultant Benzene Health Research Consortium API Administration 3Q04 Financial Report B C D E IF 2000 2001 2002 2003 Ist- 4th OtL Ist- 4th OtL Ist- 4th OtL 1st & 2nd OtL 3rd OtL G 4th OtL H IstOtL IJ 2004 2nd OtL 3rd OtL K 4th OtL L IstOtL MN 2005 2nd OtL 3rd OtL 0 4th OtL P IstOtL $0 $9,039 ($9,039) ($9,039) $26,045 $18,749 $6,552 ($2,487) $104,180 $89,669 $14,511 $12,024 $54,260 $57,297 ($3,037) $8,987 $27,130 $32,217 ($5,087) $3,900 $22,250 $32,800 ($10,550) ($6,650) $22,000 $26,745 ($4,745) ($11,395) $22,000 $25,357 ($3,357) ($14,752) $22,000 $21,839 $161 ($14,591) $20,000 $0 $20,000 $5,409 $12,000 $0 $12,000 $17,409 $10,000 $0 $10,000 $27,409 $14,000 $0 $14,000 $41,409 $10,000 $0 $10,000 $51,409 $12,000 $0 $12,000 $63,409 $0 $774 ($774) ($774) $3,256 $2,329 $927 $153 $13,022 $11,209 $1,813 $1,966 $ 6,783 $ 3,391 $7,163 $4,027 ($380) $ (636) $1,586 $950 $2,750 $ 3,000 $ 3,000 $ 3,000 $4,100 $3,343 $3,169 $2,730 ($1,350) ($343) $ (169) $270 ($400) ($743) ($912) ($642) $2,900 $0 $2,900 $2,258 $1,100 $0 $1,100 $3,358 $1,000 $0 $1,000 $4,358 $1,400 $0 $1,400 $5,758 $1,000 $0 $1,000 $6,758 $1,100 $0 $1,100 $7,858 $0 $342 ($342) ($342) $3,256 $1,487 $1,769 $1,427 $13,022 $8,004 $5,018 $6,445 6,783 $308 $6,475 $12,920 $3,391 $1,683 $1,708 $14,628 $7,500 $7,313 $187 $14,815 1,000 $0 $1,000 $15,815 $1,000 $1,152 ($152) $15,663 $3,000 $2,027 $973 $16,636 $1,000 $0 $1,000 $17,636 $1,000 $0 $1,000 $18,636 $1,000 $0 $1,000 $19,636 $5,000 $0 $5,000 $24,636 $1,000 $0 $1,000 $25,636 $1,000 $0 $1,000 $26,636 $0 $1,673 ($1,673) ($1,673) $651 $9,196 ($8,545) ($10,218) $2,604 $16,270 ($13,666) ($23,884) $1,359 $13,292 ($11,933) ($35,817) $679 $72 $607 ($35,210) $16,184 $26,276 ($10,092) ($45,302) $2,000 $3,600 ($1,600) ($46,902) $2,000 $3,808 ($1,808) ($48,710) $6,000 ($3,223) $9,223 ($39,487) $2,000 $0 $2,000 ($37,487) $500 $0 $500 ($36,987) $430 $0 $430 ($36,557) $5,000 $0 $5,000 ($31,557) $400 $0 $400 ($31,157) $400 $0 $400 ($30,757) $0 $5,752 ($5,752) ($5,752) $8,465 $4,687 $3,778 ($1,974) $33,858 $25,110 $8,748 $6,774 $ 17,635 $16,043 $1,592 $8,366 $ 8,817 $9,021 ($204) $8,162 $6,250 $ 6,200 $ 6,200 $ 6,200 $9,185 $7,489 $7,099 $6,115 ($2,935) ($1,289) ($899) $85 $5,227 $3,938 $3,039 $3,124 $ 6,000 $0 $6,000 $9,124 $3,500 $0 $3,500 $12,624 $3,000 $0 $3,000 $15,624 $4,000 $0 $4,000 $19,624 $3,000 $0 $3,000 $22,624 $3,500 $0 $3,500 $26,124 $0 $16,929 $67,717 $0 $13,886 $58,794 $0 $3,043 $8,923 $0 $3,043 $11,966 $35,269 $34,213 $1,056 $13,022 $17,635 $19,478 ($1,843) $11,179 $15,250 $17,231 ($1,981) $9,198 $28,000 $28,000 $0 $9,198 $28,000 $27,999 $1 $9,199 $28,000 $28,000 $0 $9,199 $28,000 $0 $28,000 $37,199 $10,000 $0 $10,000 $47,199 $10,000 $0 $10,000 $57,199 $10,000 $0 $10,000 $67,199 $10,000 $0 $10,000 $77,199 $10,000 $0 $10,000 $87,199 $0 $7,020 ($7,020) $7020 2000 $0 $24,600 ($24,600) ($24,600) 2000 $0 $24,600 ($24,600) $6,511 $1,712 $4,799 $2,221 2001 $65,113 $52,046 $13,067 $11,533 2001 $65,113 $76,646 ($11,533) $26,045 $0 $26,045 $23824 200 $260,448 $209,056 $51,392 $39,859 2002 $325,561 $285,702 $39,859 $ 13,565 $ 6,783 $17,000 $8,499 ($3,435) ($1,716) $LO 389 $18673 2003 $135,654 $145,316 ($9,662) $30,197 $67,826 $74,997 ($7,171) $23,026 2003 $461,215 $431,018 $30,197 $529,041 $506,015 $23,026 $5,750 ($8,250) $14,000 $32673 $75,934 $88,655 ($12,721) $10,305 $604,975 $594,670 $10,305 $ 4,500 ($4,023) $8,523 $41 196 2004 $66,700 $65,154 $1,546 $11,851 2004 $671,675 $659,824 $11,851 $ 4,500 $4,500 $0 $41 196 $66,700 $73,084 ($6,384) $5,467 $738,375 $732,908 $5,467 $4,500 $4,500 $0 $41 196 $72,700 $61,988 $10,712 $16,179 $811,075 $794,896 $16,179 $4,500 $0 $4,500 $45696 $64,400 $0 $64,400 $80,579 $875,475 $794,896 $80,579 $1,250 $0 $1,250 $46946 $29,350 $0 $29,350 $109,929 $904,825 $794,896 $109,929 $1,250 $0 $1,250 $48196 $1,250 $0 $1,250 $49446 2('05 $26,680 $40,650 $0 $0 $26,680 $40,650 $136,609 $177,259 2005 $931,505 $972,155 $794,896 $794,896 $136,609 $177,259 $1,250 $0 $1,250 $50696 $1,250 $0 $1,250 $51 946 $26,650 $0 $26,650 $203,909 $29,250 $0 $29,250 $233,159 $998,805 $794,896 $203,909 $1,028,055 $794,896 $233,159 Page 34 of43 &[DATE] SH ELL-MCCLU RG-052825 Benzene Health Research Consortium API Administration 3Q04 Financial Report QI RIs 2006 2nd OIL 3rd OIL 4lh OIL TIuIv 2007 1sl0lL 2nd OIL 3rd OIL w 4lh OIL ~ $10,000 .2 $0 $10,000 $73,409 ~ ~ $1,000 $0 $1,000 ~ $8,858 ~ 1"1 $1,000 10 $0 ~ $1,000 $27,636 $14,000 $0 $14,000 $87,409 $1,400 $0 $1,400 $10,258 $5,000 $0 $5,000 $32,636 $10,000 $0 $10,000 $97,409 $1,000 $0 $1,000 $11,258 $1,000 $0 $1,000 $33,636 $12,000 $0 $12,000 $109,409 $1,100 $0 $1,100 $12,358 $1,000 $0 $1,000 $34,636 $10,000 $0 $10,000 $119,409 $1,000 $0 $1,000 $13,358 $1,000 $0 $1,000 $35,636 $14,000 $0 $14,000 $133,409 $1,400 $0 $1,400 $14,758 $5,000 $0 $5,000 $40,636 $10,000 $0 $10,000 $143,409 $1,000 $0 $1,000 $15,758 $1,000 $0 $1,000 $41,636 I~ ~ -. L. L ~ ~ L' l. ~ ~ .,)u ;j' ~ ~ ,,)"1 ;jo ~ .", ;jts ;j~ ~ ~ "IL 4;j ~ ~ "It "I, ~ ~ :>u $400 $0 $400 ($30,357) $5,000 $0 $5,000 ($25,357) $400 $0 $400 ($24,957) $400 $0 $400 ($24,557) $400 $0 $400 ($24,157) $5,000 $0 $5,000 ($19,157) $3,000 $0 $3,000 $29,124 $4,000 $0 $4,000 $33,124 $3,000 $0 $3,000 $36,124 $3,500 $0 $3,500 $39,624 $3,000 $0 $3,000 $42,624 $4,000 $0 $4,000 $46,624 $10,000 $0 $10,000 $97,199 $10,000 $0 $10,000 $107,199 $10,000 $0 $10,000 $117,199 $10,000 $0 $10,000 $127,199 $10,000 $0 $10,000 $137,199 $10,000 $0 $10,000 $147,199 $1,250 $1,250 $0 $0 $1,250 $1,250 $53,196 $54,446 2006 $26,650 $40,650 $0 $0 $26,650 $40,650 $259,809 $300,459 2006 $1,054,705 $1,095,355 $794,896 $794,896 $259,809 $300,459 $1,250 $0 $1,250 $55,696 $1,250 $0 $1,250 $56,946 $26,650 $0 $26,650 $327,109 $29,250 $0 $29,250 $356,359 $1,122,005 $1,151,255 $794,896 $794,896 $327,109 $356,359 $1,250 $1,250 $0 $0 $1,250 $1,250 $58,196 $59,446 2007 $26,650 $40,650 $0 $0 $26,650 $40,650 $383,009 $423,659 2007 $1,177,905 $1,218,555 $794,896 $794,896 $383,009 $423,659 $400 $0 $400 ($18,757) $3,000 $0 $3,000 $49,624 $10,000 $0 $10,000 $157,199 $1,250 $0 $1,250 $60,696 $26,650 $0 $26,650 $450,309 $1,245,205 $794,896 $450,309 ~ ~ :>"1 X TOTALS $411,865 $304,673 $106,448 $107,192 $54,602 $38,070 $16,532 $16,532 $63,952 $21,974 $41,978 $41,978 $52,207 $69,291 ($17,084) ($17,084) $140,125 $84,749 $55,376 $55,376 $384,800 $227,601 $157,199 $157,199 $91,654 $23,938 $67,716 $67,716 $1,245,205 $770,296 $474,909 $474,909 $1,245,205 $794,896 $450,309 Page 35 of43 &[DATE] SH ELL-MCCLU RG-052826 A ~ Continaencv Funds "I Budgeted Actual expense CurrentVariance Cumm Variance Reallocations from UCHSC Budgeted Actual expense IL CurrentVariance l;j Cumm Variance i<L Reallocations from AHS ~ Budgeted Actual expense CurrentVariance Cumm Variance G:L Budgeted "[ Actual expense ~ L, CurrentVariance Cumm Variance ~"I L~ Budgeted ~ Actual expense ... CurrentVariance Cumm Variance ~ ~ ':'L ;j;j ~ ~ ,:,t ;jf ':'0 Budgeted Actual expense CurrentVariance Cumm Variance Budgeted Actual expense CurrentVariance Cumm Variance ~ "IL 4' TOTALS Budgeted Actual expense ~ "I; CurrentVariance Cumm Variance "1"1 CUMULATIVE TOTALS 4~ Budgeted ~ Expense "If Variance "Ie 4~ ~ 2 OL LT 7/19/04 o;j ~ Benzene Health Research Consortium Contingency Fund 3Q04 Financial Report B C D EF 2000 1st- 4th OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2000 $0.00 $0.00 $0.00 $0.00 2000 $0.00 $0.00 $0.00 2001 1st- 4th OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2001 $0.00 $0.00 $0.00 $0.00 2001 $0.00 $0.00 $0.00 2002 1st- 4th OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2002 $0.00 $0.00 $0.00 $0.00 2002 $0.00 $0.00 $0.00 1st & 2nd OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 3rd OtL $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 2003 G 4th OtL 2003 2003 $290,272 $0 $290,272 $290,272 $0 $48,839 ($48,839) ($48,839) $0 $52,634 ($52,634) ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $290,272.00 $101,473.00 $188,799.00 $188,799.00 $290,272.00 $101,473.00 $188,799.00 4Q03 Adjustment - per Technical Committee, transfer $48,839 from UCHSC expense detail to contingency because expenses not part of UCHSC 9 AHS - ex ense transfer of $52 634 from AHS ex ense detail to contin encv because ex enses not part of AHS full stud bud et Page 36 of 43 &[DATE] SH ELL-MCCLU RG-OS2827 Benzene Health Research Consortium Contingency Fund 3Q04 Financial Report H ~ 2004 1stOtr. "I $0 $0 $0 $290,272 IL l;j i<L ~ G:L "[ ~ L, ~"I L~ ~ ... ~ ~ ':'L ;j;j ~ ~ ,:,t ;jf ':'0 ~ "IL 4' 2004 ~ "I; "1"1 4~ ~ "If 2004 "Ie i nt budget: OL 1. June 2001 $25K grant to UCHSC; seed money exhausted (API & sponsor), expense not included in final grant cost estimate o;j 2. $3600 IRS fees to U of CO (this will be a yearly fee, since IRS must review at least once per year) ~ 3. 2002 invoice ($20,239) from EMBSI for final feasibility study work (very late billing to API) $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 I 2nd Otr. $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 J 3r.d Otr. $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 K 4th Otr. $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 L 1stOtr. $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 MN 2005 2nd Otr. 3r.d Otr. $0 $0 $0 $290,272 $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2005 $0.00 $0.00 $0.00 $188,799.00 2005 $0.00 $0.00 $0.00 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 0 4th Otr. $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 Page 37 of 43 &[DATE] SH ELL-MCCLU RG-052828 Benzene Health Research Consortium Contingency Fund 3Q04 Financial Report ~ "I IL l;j i<L ~ G:L "[ ~ L. ~"I L~ ~ ... ~ ~ ':'L ;j;j ~ ~ ,:,t ;j( ':'0 ~ "IL 4' ~ "I; "1"1 4~ ~ "If "Ie 4~ ~ 2 OL o;j ~ P 1sl0lL $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 QR 2006 2nd OIL 3Ld OIL $0 $0 $0 $290,272 $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2006 $0.00 $0.00 $0.00 $188,799.00 2006 $0.00 $0.00 $0.00 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 S 4lh OIL $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 T 1sl0lL $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 UV 2007 2nd OIL 3Ld OIL $0 $0 $0 $290,272 $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 2007 $0.00 $0.00 $0.00 $188,799.00 2007 $0.00 $0.00 $0.00 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 W 4lh OIL $0 $0 $0 $290,272 $0 $0 $0 ($48,839) $0 $0 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0.00 $0.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 X TOTALS $290,272 $0 $0 $290,272 $0 $48,839 $0 ($48,839) $0 $52,634 $0 ($52,634) $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $290,272.00 $101,473.00 $0.00 $188,799.00 $0.00 $0.00 $0.00 Page 38 of 43 &[DATE] SH ELL-MCCLU RG-052829 A ~ ~ INCOME "I Sponsor Payments API Interest UCHSC Interest TOTALS Reporting Period ~ Cumulative projected income U L<L LT 7/19/04 RT 7/1612004 Benzene Health Research Consortium Income 3Q04 Financial Report B 2000 1st - 4th Qtr. C 2001 1st - 4th Qtr. D 2002 1st - 4th Qtr. E 1st & 2nd Qtr. F 2003 3rd Qtr. G 4th Qtr. H 1stQtr. IJ 2004 2nd Qtr. 3rd Qtr. K 4th Qtr. L 1stQtr. MN 2005 2nd Qtr. 3rd Qtr. 0 4th Qtr. P 1stQtr. QR 2006 2nd Qtr. 3rd Qtr. $60,000 $246 $0 $2,105,509 $7,623 $0 $8,355,629 $11,817 $0 $448,024 $0 $0 $0 $ $3,186 $0 4,259,965 $5,276 $0 $1,485,875 $ $0 $0 $6,746 $6,506 $60,246 $60,246 $2,113,132 $2,173,378 $8,367,446 $10,540,824 $448,024 $10,988,848 $3,186 $10,992,034 $4,265,241 $1,485,875 $15,257,275 $16,743,149 $6,746 $6,506 $0 $0 $0 $0 $0 $0 $0 $0 $16,749,895 $16,756,401 $16,756,401 $16,756,401 $16,756,401 $16,756,401 $16,756,401 $16,756,401 $16,756,401 $16,756,401 Page 39 of43 &[DATE] SH ELL-MCCLU RG-OS2830 S ~ 4th Qtr. ~ "I T 1stQtr. UV 2007 2nd Qtr. 3rd Qtr. W 4th Qtr. X TOTALS $0 $0 $0 $0 $0 ~ $16,756,401 $16,756,401 $16,756,401 $16,756,401 $16,756,401 U L<L Benzene Health Research Consortium Income 3Q04 Financial Report Page 40 of43 &[DATE] SH ELL-MCCLU RG-OS2831 A T 2 Company Name 3 BP 4 5 6 ChevronTexaco 7 8 ConocoPhillips 9 10 11 ExxonMobii 12 13 14 15 Shell 16 17 18 Marathon 19 20 21 Total 22 23 LT 7/19/04 BC D (Seed Money) $15,000 $22,500 Inv. # 522922 528453 Date Paid 8-Nov-00 19-Jun-01 Benzene Health Research Consortium Sponsor Invoice Detail 3Q04 Financial Report EF 2001 G HI 2002 J K LM 3rd -4th Otr. N0 2003 P 22-Aug-01 $768,941 Inv. # Date Paid 529301 4-0cl-01 9-Jan-02 $806,441 Inv. # 532263 Date Paid 22-Feb-02 27-Aug-02 $1,344,069 $112,008 Inv. # 535033 Date Paid 11-0cl-02 2-0cl-02 23-Sep-03 $1,431,041.00 Inv. # Date Paid 544951 4-Dec-03 Q TOTAL $4,500,000 $15,000 522923 7-Nov-00 $522,627 529302 9-0cl-01 $537,627 532244 22-Feb-02 $896,046 535034 5-Nov-02 $1,028,700.00 544953 19-Nov-03 $3,000,000 $15,000 $7,500 522924 31-0cl-00 528574 31-Jul-01 $246,314 529309 17-Sep-01 $268,814 532245 16-Jan-02 $448,023 535035 26-Sep-02 $514,349.00 544954 27-0cl-03 $1,500,000 $0 523540 $1,612,882 $806,441 $806,441 532246 23-Jan-02 11-Feb-02 $1,344,069 535036 13-Sep-02 $1,543,049.00 $771,524.50 $771,524.50 544956 3-0cl-03 22-Mar-04 $4,500,000 $15,000 $15,000 523054 24-0cl-00 528333 15-May-01 $15,000 528541 14-Aug-01 $507,627 529305 25-Sep-01 $537,627 532247 7-Feb-02 $896,046 $448,023 $448,023 535037 25-Sep-02 10-Feb-03 Maralhon Ashland Maralhon Oil $1,028,700.00 $514,350 $514,350 $150,000 $50,000 544958 548582 548581 28 Ocl 03 14 Jan 04 20-Jan-04 3-Feb-04 $3,000,000 $215,000 $120,000 $2,045,509 $5,376,273 $5,936,307 $8,317,588.00 $16,715,000 Page 41 of43 &[DATE] SH ELL-MCCLU RG-OS2832 AB 1 ID CompanyName 2 19982 Shell Chemical 3 20086 ConocoPhillips 4 20972 ChevronTexaco 5 20239 BP International Limited 6 28285 Shell Chemical 7 28929 BP International Ltd 8 29861 ConocoPhillips 9 30179 Marathon Ashland Petroleum, LLC. 10 30853 ConocoPhillips 11 31000 Shell Chemical 12 31141 BP p.Lc. 13 31179 ChevronTexaco 14 33206 ConocoPhillips 15 34334 ExxonMobil Research and Engineering 16 34823 Shell Chemical 17 34889 ExxonMobil Research and Engineering 18 35200 ChevronTexaco 19 35207 BP p.Lc. 20 38625 ExxonMobil 21 38748 Shell Chemical 22 38779 ConocoPhillips 23 39101 BP p.Lc. 24 39214 BP p.Lc. 25 39493 ChevronTexaco 26 42934 American Petroleum Institute 27 44094 Shell Chemical 28 51153 ExxonMobil 29 51869 ConocoPhillips 30 51891 Shell Chemical 31 52332 ChevronTexaco 32 52633 BP p.Lc. 33 54618 Marathon Ashland Petroleum, LLC. 34 54472 Shell Chemical 35 55187 Marathon Oil Company 36 57362 ExxonMobil 37 38 RT 5/5/04 39 LT7/19/04 Benzene Health Research Consortium Sponsor Payment Detail 3Q04 Financial Report PaymentDate C 10/24/2000 10/3112000 1117/2000 1118/2000 5/15/2001 6/19/2001 7/3112001 8/14/2001 9/17/2001 9/25/2001 10/4/2001 10/9/2001 1116/2002 1/23/2002 2/7/2002 2/1112002 2/22/2002 2/22/2002 9/13/2002 9/25/2002 9/26/2002 10/2/2002 10/1112002 1115/2002 1117/2003 2/10/2003 10/3/2003 10/27/2003 10/28/2003 11119/2003 12/4/2003 1/20/2004 1113/2004 2/3/2004 3/22/2004 (note - does not include interst income) D PaymentAmount $ 15,000.00 $ 15,000.00 $ 15,000.00 $ 15,000.00 $ 15,000.00 $ 22,500.00 $ 7,500.00 $ 15,000.00 $ 246,314.00 $ 507,627.00 $ 768,941.00 $ 522,627.00 $ 268,814.00 $ 806,441.00 $ 537,627.00 $ 806,441.00 $ 537,627.00 $ 806,441.00 $ 1,344,069.00 $ 448,023.00 $ 448,023.00 $ 112,008.00 $ 1,344,069.00 $ 896,046.00 $ 1.09 $ 448,023.00 $ 771,524.50 $ 514,349.00 $ 514,350.00 $ 1,028,700.00 $ 1,431,041.00 $ 150,000.00 $ 514,350.00 $ 50,000.00 $ 771,524.50 $ 16,715,001.09 E TOTALS yr 2000 $ 60,000.00 yr 2001 $ 2,105,509.00 yr 2002 $ 8,355,629.00 1+2Q03 $ 448,024.09 4Q03 $ 4,259,964.50 1Q04 $ 1,485,874.50 $ 16,715,001.09 F 3Q03 $- Page 42 of43 &[DATE] SH ELL-MCCLU RG-OS2833 A 1 Company 2 American Petroleum Institute 3 BP International Limited 4 BP International Ltd 5 BP p.Lc. 6 BP p.Lc. 7 BP p.Lc. 8 BP p.Lc. 9 BP p.Lc. 10 ChevronTexaco 11 ChevronTexaco 12 ChevronTexaco 13 ChevronTexaco 14 ChevronTexaco 15 ConocoPhillips 16 ConocoPhillips 17 ConocoPhillips 18 ConocoPhillips 19 ConocoPhillips 20 ConocoPhillips 21 ExxonMobil Research and Engineering 22 ExxonMobil Research and Engineering 23 ExxonMobil 24 ExxonMobil 25 ExxonMobil 26 Marathon Ashland Petroleum, LLC. 27 Marathon Ashland Petroleum, LLC. 28 Marathon Oil Company 29 Shell Chemical 30 Shell Chemical 31 Shell Chemical 32 Shell Chemical 33 Shell Chemical 34 Shell Chemical 35 Shell Chemical 36 Shell Chemical 37 38 LT7/19/04 BC D Date Paid Amount 1117/2003 $ 1.09 (I am trying to get this $1.09 removed from the books) 1118/2000 $ 15,000.00 6/19/2001 $ 22,500.00 10/4/2001 $ 768,941.00 2/22/2002 $ 806,441.00 10/2/2002 $ 112,008.00 10/1112002 $ 1,344,069.00 BP Total 12/4/2003 $ 1,431,041.00 $ 4,500,000.00 1117/2000 $ 15,000.00 10/9/2001 $ 522,627.00 2/22/2002 $ 537,627.00 1115/2002 $ 896,046.00 ChevronTexaco Total 11119/2003 $ 1,028,700.00 $ 3,000,000.00 10/3112000 $ 15,000.00 7/3112001 $ 7,500.00 9/17/2001 $ 246,314.00 1116/2002 $ 268,814.00 9/26/2002 $ 448,023.00 ConocoPhillips Total 10/27/2003 $ 514,349.00 $ 1,500,000.00 1/23/2002 $ 806,441.00 2/1112002 $ 806,441.00 9/13/2002 $ 1,344,069.00 10/3/2003 $ 771,524.50 ExxonMobil Total 3/22/2004 $ 771,524.50 $ 4,500,000.00 8/14/2001 $ 15,000.00 1/20/2004 $ 150,000.00 Marathon Ashland Total 2/3/2004 $ 50,000.00 $ 215,000.00 10/24/2000 $ 15,000.00 5/15/2001 $ 15,000.00 9/25/2001 $ 507,627.00 2/7/2002 $ 537,627.00 9/25/2002 $ 448,023.00 2/10/2003 $ 448,023.00 10/28/2003 $ 1113/2004 $ 514,350.00 514,350.00 $ Shell Chemical Total 3,000,000.00 $ 16,715,001.09 SH ELL-MCCLU RG-OS2834 From: Sent: To: Subject: Attach: Cagen, Stuart Z SCC-CF-SS <stuart.cagen@shell.com> Thursday, June 23,2005 10:21 PM (GMT) Cagen, Stuart Z SCC-CF-SS <stuart.cagen@shell.com>; Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com>; Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> FW: BHRC-TC... Handout for EA ConfCall - Fri 12110, llam EST 121004 DRAFT SHS EA ver 4.ppt Memories... Of possible use for the call tomorrow morning. Looks like there will be a combined call tomorrow, with Otto joining the call with Tom, et al at 930 am Houston time Stuart Cagen Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713241 1407 Fax: 3325 Other Tel: +1 8326463987 Email: stuart.cagen@sheILcom Internet: http://www.sheILcom/chemicals "Business Success through HSSE Excellence" -----Original Message----From: Bruce Jarnot [mailto:jarnotb@apLorg] Sent: Thursday, December 09, 2004 5:47 PM To: benzconsort-tc@listserve.apLorg Cc: Lorraine Twerdok; Howard Feldman Subject: BHRC-TC... Handout for EA Conf Call - Fri 12/10, llam EST Attached is Tom Armstrong's handout (ppt file) for Friday morning's Exposure Assessment conference calL .. Best Regards - Bruce. -----Original Message----From: Bruce Jarnot Sent: Tuesday, December 07, 2004 10:50 AM To: benzconsort-tc@listserve.apLorg Cc: Howard Feldman Subject: BHRC-TC... REMINDER - EA Conf Call - Fri 12/10, llam EST Importance: High Benzene Health Research Consortium (BHRC) Technical Committee - REMINDER... we have a conference call scheduled this Friday, Dec 10th, to review Exposure Assessment (EA) progress in the Shanghai Health Studies with Tom Armstrong, Rob Schnatter and Yimei Zhou: Date: Friday, Dec 10 Time: 11 :OOam - 2:00pm EST Dial-in: 763/315-6900 (or toll free 866/448-6756) SH ELL-MCCLU RG-052835 PIN code: 6828319# Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Room 1025) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org <mailto:jarnotb@api.org> SH ELL-MCCLU RG-OS2836 Review of SHS Exposure Assessment 10 December 2004 Tom Armstrong Rob Schnatter Yimei Zhou DRAFT 1 SH ELL-MCCLU RG-OS2837 Overall Study Aims and Values Case Control (PI: Otto Wong I Fu Hua) Is NHL associated with benzene? If so, is NHL / benzene specific to NHL subtype? What is shape of dose-response curve for NHL and AML? Provide comment on NCI NHL / benzene study Disease Progression (PI: Rich Irons I Fu Hua) Does benzene-induced disease have a distinct pattern? Does benzene-induced cancer progress through requisite steps? What is shape of dose-response curve for MDS and AA? May have impact on "safe" levels Molecular Epidemiology (PI: Rich Irons I Fu Hua) What is shape of dose-response for blood effects? (Phase 1, 2A) What is earliest marker for effects? (Phase 1, 2A, 28) Does benzene induce toxicity more readily in susceptible workers? (Phase 2A, 28) Provides mechanistic insight; possible protection strategy in some settings Are there requisite steps for later markers (blood count decrements)? (Phase 2A, 28) Does benzene act on bone marrow differently than peripheral blood? (Phase 28) If so, provides insight on mechanisms, thresholds Could provide new basis for dose-response DRAFT 2 SH ELL-MCCLU RG-OS2838 Study Positives State-of-the-art lab Improved diagnostic capabilities New WHO scheme for LH disease classification enabled Tissue storage allows future research Patient population directly benefiting from improved diagnoses / treatment Reputation for diagnosis reflected by more signatory hospitals Unique resource for research Preliminary results already suggest threshold for blood effects Preliminary results suggest bone marrow changes in absence of peripheral blood Could be unique benzene signature for myelodysplasia Enhancing IH capabilities in Shanghai / China Comments / review Study obtained positive feedback at recent worldwide conference Esteemed SRP and ERB has favorably reviewed study Study may be helping to reduce benzene exposure in Shanghai DRAFT 3 SH ELL-MCCLU RG-OS2839 EA Progress Summary 10? 100-200? DRAFT 4 SH ELL-MCCLU RG-052840 Deliverables Associated with Each Study Molecular Epidemiology Scope Phase 1: Phase 2A: Phase 2B: 2000 workers 1000 workers 200 workers EMBSI Activities I Deliverables Design Questionnaires Design Training of staff Abstraction forms Factory selection Exposure assessment QA/QC Statistical analysis Publication assistance Presentations assistance Status Complete Complete Complete Complete In progress In progress In progress Future Future Future Actual Effort +5% (see CC) 2X (see CC) Future Future Future DRAFT 5 SH ELL-MCCLU RG-OS2841 Deliverables Associated with Each Study (cont'd) Disease Progression I Case Control Planned Scope BZ poisoning cases: Aplastic anemia: MDS: AML: NHL: Controls: Total: 50 250 300 600 600 3600 5400 EMBSI Activities I Deliverables Design Questionnaires design Training of staff - Quest. administrators - Clinical coordinators - Exposure Assessment Control selection Exposure assessment QA/QC Some statistical analysis (DP) Some publications (DP) Some presentations (DP) Status Complete Complete Complete Complete Complete Complete Complete In progress In progress Future Future Future Actual Effort +20% +60-70% Retune +30% " + 20-30% " +20-30% +2-3X In progress Future Future Future DRAFT 6 SH ELL-MCCLU RG-OS2842 EMBSln imeline [ .a.C -e-l,l EMBSI $ Plan $ Actual - Na c -e-l,l - 21i2 K 132 K Ii 718 K 624 K - (") a Ol :::J - "a<t C -e-l,l ~ 1,213K 1,192K 1,576K 1,533K Project Milestones Protocols approved Agreements with Fudan, CDC,IPHS Lab & Studies Start Field testing, ME Pilots Lab& Studies Start EMBSI Planned Work Protocols: write, review, approve EMBSI Actual Work Protocol write, review, approve Staffing, EA support materials, training Troubleshoot, Monitor, Reviews Design & ov,:::.rsight for EA - AMLlNHL Study (2) Questionnaire development Staffing, EA support materials, training (1) l Design & OVerSight for EA - AMLlNHL Study "I ;~~::::hoot, Monnor, " JCML Database for EA (3): ------------------------------------------.~.i Questionnaire development (4) ;-----------------------------------------------+i~i EMBSI reviews CDC lab & I provides lab QA support(5) Import delays (Chines regulation driven) IPHS Role Change EA crew to Comments Agreements & revisions with Fudan, IPHS, CDC Fudan recruiting EA questionnaires _________________________________________________________.~ YZ begins support SARS Turnover Notes: (1) Extended due to project start delays, changing agreements and Fudan staff reassignments (2) Added per SRB request and budget increased (3) Need identified by PI Team DRAFT (4) Extended due to add in of AMLlNHL Study EA support (5) Unanticipated need covered by EMBSI New IH Lab EA Reviews, EA Committee, Local management issues 7 SH ELL-MCCLU RG-052843 EMBSl-=.. imeline Forward P)a n IJ') o C -e-l,l EMBSI $ Current Plan-1 ,650K $ Proposed Plan -1,650K Does not include XOM sweat equity Project Milestones Current Project Milestones Proposed oco Io"- C -e-l,l C -e-l,l -2,OOOK -2,300K End case accrualI End EMB?I contract I'-2800K 3,200K Begin analyses : iPublications drafted End case accrua Begin analyse , Publications drafted End EMBSI contract EMBSI Current Planned Work Troubleshoot, Monitor, Reviews ~i Analyses DP, ME & P4blications prepared EMBSI Proposed Work Troubleshoot, Monitor, Reviews Additional on-site technical & management ~ Analyses DP, ME & -----------''----------i+~ Publications ~ repared (facilitate increased technical resourcing, me:ntoring, communication; EA QA oversight, facilitate on-going Fudan/lPHS co~tributions) I Analytical QA support I I DRAFT 8 SH ELL-MCCLU RG-OS2844 SHS EMBSI BUDGET 1800000 1600000 1400000 1200000 .~ CI) > 1000000 cu ::::J E ::::J 800000 0 600000 400000 200000 o Y./ /.,r/ ./ ././ ./ ./ /."........./. / . / ..... ..... / . , / ' . ,/'./..... / ./ .....""/ ...../ . /. ./" ,,/ ./ ; //.//,,/,// ..... / / . /..... / ,..,.././" ./ ./ .................. .......... ~./ ././ /././. ./ .....,..,.."../...... / ./ ./ ././ /./.".......,," ././ ~....../ ...............,," ~ ~ ~~~ ~~ ~~~ ~ ~ ~ ~ ~~ ~ ~ ~ c:;0~" ~o~ ')0-~' ~rS:-' ~1;\' ').s.' c:;0~" ~o~ ')0-~' ~rS:-' ~1;\' ').s.' c:;0~" ~o~ ')r:" ~rS:-' ~1;\' ').s.' c:;0~' Month DRAFT -Spent - Control Budget 9 SH ELL-MCCLU RG-052845 Exposure Assessment Options Review of strategies and study impacts DRAFT 10 SH ELL-MCCLU RG-052846 Case Control Studies Tiered Design: Expectation of Fewer Subjects Completed at Higher Tiers Robust database, site visits, task data, retro EA skills Quantitative & Pattern of Exposure SH ELL-MCCLU RG-OS2847 CC / DP Exposure Assessment Design Hospital recruitment, cases of BP 1 (10/year) AA 2 (50/year) MDS 3 (GO/year) AML 4 (120/year), NHL 5 (120/year) Actual 8/day Questionnaires L...{) 1080 /year, 5/day ~ ~ Initial exposure assessment - work history, -IPHS database - facility records, - Other I Two matched controls selected per case Fudan Exposure Assessment Team Clarify or Verify & characterize main exposures No or? v Construct Detailed Exposure Assessment Job - facility - exposure - time matrix I Yes Fudan Exposure Assessment Committee I Exposure reconstruction - historic measurements, history of changes in methods, facilities, materials, etc. - retrospective estimation - physical recreation DRAFT I Exposure surveys - facility summaries - worker or surrogate exposure monitoring - air samples - biological monitoring SH ELL-MCCLU RG-052848 EA Tiers: Design Basis for SH Studies Case Control Studies DP Case Series (1) AMLlNHL, Broad DP (1) Quantitative -Quantitative doseresponse -Links to studies used in risk assessments -Quantitative doseresponse -Links to studies used in risk assessments ME Studies (2) Phase 1 Phase 2A Underway as planned Quantitative dose-response Phase 2B Links to studies used in risk assessments SemiQuantitative Ranks Qualitative Ranks -Semi-Quant. "dose" response -Semi-Quant. causal link -Semi-Quant. link to studies used in risk assessments Group differences in risk -Semi-Quant. "dose" response -Semi-Quant. causal link -Semi-Quant. link to studies used in risk assessments Group differences in risk -Semi-Quant. "dose" response -Semi-Quant. causal link -Semi-Quant. link to studies used in risk assessments Ever Exposed Never exposed Association with disease Association with disease Note 1: For the CC/OP studies, all tiers have a "certainty" rating and these generally decrease at the higher tiers Note 2: "lower tiers" not planned or needed in the ME studies. Semi-quantitative ranks may be applied in some factories for Phase 1, but full quantitative assessment planned. DRAFT 13 SH ELL-MCCLU RG-052849 CC/DP Studies - Bz EA Impact Analysis Stop Point Quantitative Semi Quantitative 0- 0.3 mg/m3 0.3 to 3 3to 40 > 40 Qualitative range No Low Medium High Study Impact Discussion -Best evidence of causal links -Data for use in risk assessment -Currently planned for -10% of subjects -Requires additional investigative effort for site reviews, additional retrospective EA skills, robust analysis of IPHS database and other quantitative data sources -Most difficult tier to complete -Costs - medium - high -Probability of Success -low -Value -high -Improved evidence of causal links -Semi-quant. link to quantitative risk assessments -Work site screening visits -Difficulty - medium -Costs - medium -Probability of Success - medium -Value - medium -Risks by groups for stronger information or possible causal link for diseases of concern -Difficulty - low - medium -Costs -low -Probability of Success - high -Value - low-medium Read Here to Top Everexposed,never exposed -Only potential relationship of benzene or other exposures to diseases of concern -Questionnaire driven -Difficulty - low -Probability of Success - high -Value -low SH ELL-MCCLU RG-052850 Go-forward Options DRAFT 15 SHELL-MCCLURG-052851 Many Factors Lead to Project Success Cultural & Political Management Technical Resourcing I 16 SH ELL-MCCLU RG-OS28S2 Opportunities Action Item #1 yz assignment to Shanghai and more EA support Expected Benefits EA staff morale, productivity, leadership; understanding Fudan / IPHS drivers, EA qualifications, less EA staff resource diversion Implementor EMBSI #2 Fund extension of the study Increase subject numbers, more insight on disease mechanisms (from ME/DP), more power for case control less chance of spurious findings Oversight Committee #3 Re-engage IPHS More efficient factory selection, EA, more insight on IPHS database limitations PI's #4 Further support the Fudan team Continuous Improvement of PI Oversight Committee collaboration, YZ effectiveness, post- study prob. of lab utilization #5 Periormindependent QAlQC audits of Fudan IH laboratory and field (questionnaire EA) work Ensure data integrity Member CO's, external resource DRAFT Enabler Technical/Oversight Committees FU's support PI involvement in EA Technical/Oversight Committees Factory access through IPHS PA/Member Companies Technical/Oversight Committees Technical Committee 17 SH ELL-MCCLU RG-052853 Recommendations: Maintain Full Scope of SHS Continue Planned Quantitative EA for CC/OP Studies Continue Recruitment of Subjects for ME liB Maximizes Value of Study Results for Risk Assessments Requires Extension through 2007 Requires Additional $3.3M Funding DRAFT 18 SH ELL-MCCLU RG-OS28S4 From: Sent: To: Subject: Matt Todd <ToddM@api.org> Thursday, June 30, 2005 8:35 PM (GMT) BHRC Oversight Committee (E-mail) <benzconsort-oc@listserve.api.org>; BHRC Technical Committee (E-mail) <benzconsort-tc@listserve.api.org>; BHRC Communications Committee (E-mail) <benzconsort-cc@listserve.api.org> Shanghai Health Study Update: July 1,2005 Shanghai Health Study Update Announcements: Please register for the 2005 SHS Annual Meeting. The registration form is posted on the SHS Update page under the 2005 SHS Annual Meeting heading. Please e-mail the registration form directly to Matt Todd and contact the Ritz-Carlton directly to arrange for your stay. The 2005 SHS Annual Meeting draft agenda is posted on the SHS Update page. The Communications Committee has scheduled a conference call on July 11th at 3PM EDT. The Technical Committee has scheduled a conference call on August 25th at 11 AM EDT. The final minutes from the Oversight Committee conference calls (July 27th, 28th, and 30th) will be posted on the Oversight page upon receipt. If you have any announcements that you would like to be posted, please send an email to Matt Todd. Matthew Todd Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005 p: (202)682-8319 f: (202)682-8031 www.api.org SH ELL-MCCLU RG-052855 SHANGHAI HEALTH STUDY Patsy Clegg Oversight Committee Chair 1220 L Street, NW Washington, D. C., 20005 July 18, 2005 Dear Dr. Mehlman, As chair of the Shanghai Health Study Oversight Committee, it has come to my attention that you sent letters to various executives of the companies sponsoring the study. This independent scientific study being conducted in Shanghai, China is sponsored by a group of companies who have a strong commitment to public health, safety and product stewardship. With the Shanghai Health Study, the sponsors seek to advance the medical and scientific knowledge about any disease process or potential health risk from exposure to benzene Continued scientific investigation is recognized by the scientific and medical communities as the basis for effective assessments of the toxicity and potential health risk of substances such as benzene. The present study was designed by preeminent scientists independent of the sponsoring companies and is being conducted by Principal Investigators who are research scientists at Fudan University in Shanghai, the University of Colorado Health Services Center and Applied Health Sciences, an independent research firm in San Francisco. The research is being overseen by scientific and ethics review panels composed of 14 world-renowned, independent experts in relevant field. The independent Principal Investigators conducting the study have full responsibility for the research as well as conclusions that may be drawn from the data when the study is completed. It is my understanding that upon completion the researchers intend to submit study findings for publication in peer-reviewed scientific journals. Sincerely, Patsy Clegg Administrative support provided by The American Petroleum Institute 1220 L Street, Northwest Washington, DC 20005-4070 SH ELL-MCCLU RG-052856 From: Sent: To: Subject: Attach: Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> Tuesday, July 19,20056:45 PM (GMT) Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Cagen, Stuart Z SCC-CF-SS <stuart.cagen@shell.com>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Michael Johnston <Mike.dJohnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Twerdok, Lorraine (E-mail) <twerdokl@api.org>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail)<russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Colletti, Sarah J SCC-CSEA <sarah.colletti@shell.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail)<vcrissey@chevrontexaco.com>; John Wagner (E-mail) <wagner@api.org>; Mark Fitzsimmons (E-mail) <mfitzsim@steptoe.com> Mehlman Letter Shanghai Health Study.zIP Team, Attached is the letter to Dr. Mehlman. ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SH ELL-MCCLU RG-052857 From: Sent: To: Subject: Matt Todd <ToddM@api.org> Monday, August 1, 20056:33 PM (GMT) BHRC Oversight Committee (E-mail) <benzconsort-oc@listserve.api.org>; BHRC Technical Committee (E-mail) <benzconsort-tc@listserve.api.org>; BHRC Communications Committee (E-mail) <benzconsort-cc@listserve.api.org> Shanghai Health Study Update: August 1, 2005 Shanghai Health Study Update Announcements: The Technical Budget Subcommittee has scheduled a conference call to review the 2Q 2005 draft financial report tomorrow, August 2nd at 2:30 PM EDT. The Oversight Committee has scheduled a conference call on August 11th at 2:00 PM EDT. Agenda details are located on the SHS Update page. All BHRC Committee Members are invited to attended a meeting scheduled on August 18th in Bartlesville, OK at ConocoPhillips. Agenda details are located on the SHS Update page. The Technical Committee has scheduled a conference call on August 25th at 11 AM EDT. Agenda details are located on the SHS Update page. The final minutes from the Oversight Committee conference calls (July 27th, 28th, and 30th) are posted on the Oversight page. If you have any announcements that you would like to be posted, please send an email to Matt Todd. Matthew Todd Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005 p: (202)682-8319 f: (202)682-8031 www.api.org SH ELL-MCCLU RG-052858 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Monday, August 22,20053:36 PM (GMT) benzconsort-tc@listserve.api.org benzconsort-oc@listserve.api.org; benzconsort-cc@listserve.api.org BHRC-TC... 3rd Mid-Year SHS Progress Report: Exposure Assessment Fudan Progress Rpt 08 200S.pdf BHRC Technical Committee (-TC) With copy to Oversight, Technical Committees Attached is a copy of the mid-year 2005 SHS Progress Report from Dr. Fu Hua (Fudan University). This is the final pending semi-annual report; those received from Drs. Irons (DP & ME Studies) and Wong (CC Study) were sent under separate cover last week. Copies of all progress reports are also available on the SHS web site... With best regards - Bruce. PDFAttach. SH ELL-MCCLU RG-052859 SHS Semi-annual Report July 14, 2005 By Fudan University School of Public Health SH ELL-MCCLU RG-052860 1. Summary During the last 6 months, Questionnaire Takers interviewed 830 subjects for CC/DP Study, for an average of about 40 cases per week. The EA team visited 15 factories, gathered historical industry information and drafted a comprehensive benzene exposure historical summaries for shoe-making and textile printing industries; conducted site monitoring at 25 factories and collected 350 personal, area and bulk samples. Out of the total of 3775 Questionnaires collected so far, 3308 went through preliminary exposure assessment and the current "benzene exposed rate" remains around 7%. Due to the lack of availability and accessibility of complete historical IPHS information, Exposure assessment for the CC/DP study has shifted its focus from a case-to-case based study to sector analysis. For the ME phase I study, medical records of 1600 cases were collected and entered into an Access database. Exposure Assessment, although slower than expected due to limited factory and information access, is progressing. So far, the EA team visited 11 factories for the ME Phase I, and additional 7 factories have exposure assessment site investigations pending. No progress was made for ME phase II study because factory mangers couldn't accept consent forms. Issues, challenges and suggestions were summarized as follows: Evaluate second level questionnaires to make them more feasible and valuable Inadequate involvement of IPHS is still an obstacle against prompting the EA process. More efforts (resources) are needed from IPHS to speed up factory visit. Very limited access to IPHS database. Negotiation with CDC is necessary to get more data. Fudan investigators should be kept informed on the exposure assessment focus and strategy. More workers are needed for ME phase I study. But, it seems difficult to find information out of Shanghai. Factories couldn't accept ethical requirements of ME phase II study. A meeting is proposed to discuss factory enrollment in August. Senior occupational physicians and bioethical scientists should attend this meeting. 2 SHELL-MCCLURG-052861 2. General Management After dialog and interaction among the Pis of the study during the early part of the year, the Fudan EA team has worked on improving communications. Through weekly staff meetings and monthly reports to Pis, the Fudan team maintained communication with both the team members and the Pis overseas. These monthly reports not only captured progress made, but also communicated the technical questions raised by the EA team. During this period, the team welcomed two new members who joined the team to fill in gaps left by a graduation and a pregnancy. With the project deadline approaches so far, we have not lost any team members. Keeping the team together in a cohesive and motivated unit is increasingly important as we get closer to the project completion. The Fudan EA team also played a key role in interacting with IPHS. Fudan has initiated meetings with IPHS at least once a month to address issues related to data and factory access. However, keeping EA team members of Fudan fully informed and transparent on a strategic basis of foreseeing EA approaches remains to be further prompted. In addition to the "personnel management", more technical supports and team capacity building are preferably appreciated. Task should ideally assign through the group leader instead of delivering to individual team member directly. 3. Technical PROGRESS 3.1 CC and DP studies 3.1.1 Questionnaire administration Up to June 25th, 2005, 3375 subjects have been interviewed; 1885 secondary questionnaires were applied. A total number of 850 subjects, including both case and controls, were interviewed in the last half year, and of these, 484 subjects had the secondary questionnaires applied. Data collected from the Questionnaires was reviewed immediately after the collection and phone interviews were used as follow up to further clarify any questions that the QA coordinator may have. The first time pass rate is at around 89%. 3.1.2 Control selection QA has worked closely with the hospital coordinators to ensure that control 3 SH ELL-MCCLU RG-OS2862 selection adheres to the selection criteria, only 1.1 % was found being selected from the same departments of the relevant hospitals; and 2 controls (0.4%) were repeatedly selected. All of these selected controls were excluded out; and the new controls were selected according to the selection criteria. Control distribution: see the annexed table: distribution of inpatients in 68 hospitals (2002, Shanghai) vs. CC/DP controls. 3.1.3 Data entry and validation In the last six months, data entry has kept with the pace of Questionnaires Administration, only one week lag behind the interview.. The data entry error rate remained at about 2%. 3.1.4 Exposure assessment The EA team has taken on an active role to pursuing information related to the potential exposure scenarios. Main activities and accomplishment by the EA team include: Coded all cases and controls with industry coding developed during the third National Census Guideline. Completed preliminary assessments and make qualitative judgments of cases or controls that are exposed to benzene and other substances based on information on the Questionnaires. Gathered historical exposure data from IPHS or follow-up site investigations. During the last six months, the EA team visited 15 factories and collected personal, area and bulk samples. Completed summary reports and documented information collected for all cases and controls accumulated since last year. Table 1 Current status of the case distribution in CC/DP Study. Table 1 Summary of CC/DP exposure assessment (2003.5-2005.5) Preliminary exposure assessment Completed to date No. subjects that needs further follow-up by EAC No. of subjects exposed to other substances Interim benzene exposure rate (7%) Benzene exposed Benzene potentially exposed 3308 277 2631 112 121 During the last 6 months, 1228 subjects were assessed to clarify their potential exposures. 1130 of the 1228 subjects (92.02%) were identified as "non-exposed" or "exposed to other chemicals only except benzene"; 98 4 SH ELL-MCCLU RG-OS2863 subjects (7.98%) were identified as "potentially benzene exposed" that were followed-up for further quantitative assessment. Of these, 52 subjects were accomplished for a qualitative EA; and 4 for the quantitative EA. Although the estimated benzene exposure rate is at about 7%, the final assessment may be slightly lower. These "potentially benzene exposed" subjects are mainly from the following industries. Industry Distrbution of Benzene Exposed Cases 9% D Printing Figure 1. The distribution of Benzene exposed subjects by industry During the last six months, the EA team has found that one-on-one matching of a subject's working place based on IPHS database has proven to be far from fully effective. Only 3-5% factories of the subjects worked can be identified in the IPHS database, and the area samples taken often do not match the work area/task or time period the subject worked in that factory. Therefore, the project is forced to further evaluate an alternative from the protocol for the retrospective Exposure Assessment strategy. A closer look at the IPHS database by industry, breaking down the database by the factors that contribute most to the exposure level - production scale and facility environment, time period, location and task could render some useful information, at least on the range of exposure level. Such information needs to be further verified through other information resources such as published literature, expert input and most important of all when possible, site investigations. The access of the whole database has been withheld by IPHS and that has hindered the effort for sector analysis. Nevertheless, the Fudan EA team has been focusing on the following areas: 5 SH ELL-MCCLU RG-OS2864  Continued efforts to follow up on information regarding the exposure of each individual subjects Grouped all cases from the same industry together and analyze its commonalities and difference Sought information to better understand the industrial process and job/tasks that are related to benzene exposure and gather information that could contribute to the re-construction of historical exposure scenarios. Collected over 200 Chinese literature related to the benzene exposure Visit to factories and district IPHS, worked with people who directly conducted site monitoring, interviewed service personnel, and conducted current site exposure monitoring. 3.2 ME Study 3.2.1 ME phase I 3.2.1.1 Medical records collection For 2221 cases, historical medical records from 25 factories were collected by the Yangpu Central Hospital. HistoricallH background information and monitoring data were collected from three sources - factory records, IPHS database and/or occupational hospital records. As the critical regulatory requirements for record keeping did not effectively enforced until the passage of Occupational Disease Prevention and Control Act in 2001, often historical data were no longer available. Two factories with a total of 255 cases were disqualified due to inadequate supporting records. 3.2.1.2 Standardization and data entry Before data entry, names of job titles of workers were standardized through factory managers, senior workers. Medical records from 15 of the 20 factories were double-entered per QA procedures, and validation is currently under way. 3.2.1.3 Exposure Assessment Re-construction of historical exposure levels takes several steps and the only way to reconcile historical hematological data is through site investigations. So far, 10 of the 18 factories were visited by the EA team, with a total of 250 exposure assessment samples taken at the sites. Once the data are available, the EA team associates each of the worker's historical exposures to a job location/task through a coding system, So far, re-construction of historical exposure is completed for about 300 cases from 6 6 SH ELL-MCCLU RG-052865 factories. 3.2.2 ME phase II Although Fudan has been negotiating with factories, no worker has been successfully recruited for ME II study. A file has been submitted to Dr Irons to help him understand the critical problems of ME II study. 4. Issues, Challenges and suggestions 4.1 CC and DP studies 4.1.1 The second level questionnaires FUSPH (Fudan School of Public Health) translated all the 63 types of occupations/jobs into Chinese. Although the second level questionnaires were used successfully in USA, the questionnaires often make both interviewer and interviewee confused and lost confidence in responding them. Very limited valuable information could be collected through 2nd questionnaire. Fewer questionnaires were used by EAC to support exposure assessment. Comments on 2nd questionnaires were collected from questionnaire administrators. The Fudan team would like to suggest that US experts evaluate current status of 2nd questionnaire usage and make them more feasible and more useful. 4.1.2 Inadequate involvement of IPHS Inadequate involvement of IPHS is still an obstacle against prompting the EA process. It was agreed early this year that IPHS staff would participate weekly EAC meeting. However, IPHS participated in only 2 EAC meetings. Field visits to 17 factories were arranged in the first half of this year. The IPHS coordinator could spend only 1 day per week for CC/DP and ME studies. Recruitment of a full-time staff, which is ideally familiar with the role of IPHSs and the trendy changes of relevant industries, is needed, so that we can visit factory under a more responsive and effective way. 4.1.3 Access to IPHS database Full access to the IPHS database is essential to the sector analysis approach. Currently, IPHS has refused to provide full access, citing complains from other study parties with which IPHS is collaborating. Actions to prompt IPHS re-engaging are under reviewed. 4.1.4 Technical supports to exposure assessment team EAC was directed to focus on "sector analysis" and to estimate the exposure level in terms of 'high', 'medium' and 'low' according to the factory size in May. The questions are: 1) how to define factory size; and 2) the factory size doesn't 7 SH ELL-MCCLU RG-OS2866 necessary proportionally relate to exposure level. However, no further clear and constructive guidelines have been provided by US experts, which need to be more transparent and technically supportive. Further communication between US and Fudan investigators is needed. Fudan investigators should be kept informed about the adjustment of exposure assessment strategy. Fudan investigators understand that the EA is one of the most complicated issues for SHS, and it's difficult to answer all questions at thee moment. However, we are hoping that all important decisions would be made based on scientific judgment and agreed with the Pis. 4.2 ME study 4.2.1 ME phase I study After the qualification process, only a little more than half of the cases collected for ME Phase I study will be usable. Therefore, more factories need to be recruited. The Fudan Team and Dr. Ni both explored the possibility of reaching out to other sources for the information out-side Shanghai. However, historical records were not kept in these areas as complete and systematic as in Shanghai. 4.2.2 ME Phase II Study Several candidate factories were approached but none of them could accept the ethical requirements and were willing to sign the consent form on behalf of workers. The ME II study would not be approachable unless the Ethical Committee would consider a different approach. 8 SH ELL-MCCLU RG-OS2867 Annexed table 1 : Disease distribution of inpatients in 68 hospitals (2002, Shanghai) vs. CCIDP controls (between Jan. to Jun. 2005) sort of disease infectious disease and vermmOSlS cancer incretionary disease,nutrition related disease, metabolic disease,immune disease blood and hematopoietic organ related disease mental disease Neurologic system disease and sense organ related disease Ciru1ation system disease Respiratory system disease Digestive system disease Urinary system disease cyesis,delivery and complication of the puerpenum dermal and hypodermis disease muscle and skeletal system disease, connective tissue disease inherent abnormality condition from perinatal period unknown of sign and symptom impairement and intoxication others number of Number of proportion( % ) Proportion ( % ) discharged patient SHS controls 12952 74460 1.90 10.92 5 0.94 82 15.36 15859 2.33 31 5.81 4448 941 27642 100827 93602 105418 40459 82255 4542 16156 4472 3461 6040 54607 43742 0.65 0.14 4.05 14.79 13.73 15.46 5.93 12.06 0.67 2.37 0.66 0.51 0.89 8.01 6.41 0 0.00 0 0.00 51 9.55 84 15.73 55 10.30 76 14.23 64 11.99 5 0.94 5 0.94 54 10.11 0 0.00 0 0.00 12 2.25 5 0.94 5 0.94 9 SH ELL-MCCLU RG-OS2868 total 681883 100.00 534 100 10 SH ELL-MCCLU RG-OS2869 From: Sent: To: Cc: Subject: Attach: Fu Hua <hfu@shmu.edu.cn> Thursday, August 18, 2005 1:26 PM (GMT) 'shanghaihealthstudy' <info@shanghaihealthstudy.org>; 'Bruce Jarnot' <jarnotb@api.org> Tsai, Shan P SHLOIL-SHS <shan.tsai@shell.com> ??: Fudan University budget adjustment SHS_semi-annual report_200S June.doc Dear Bruce I am sending you our semi-annual report. I am sorry to delay so long time to send it to you because the cycle of review for American team cost much time. If you have any questions and comments on it please don~ hesitate to let me know. As there is always some problem with the internet communication, I would appreciate if you would give me an acknowledgement. Regards FuHua ************************* Fu Hua. MB, MPH, PhD Deputy Dean and Professor School of Public Health Fudan University PO Box 248 138 Yixueyuan Road Shanghai 200032 PR China Tel.: 86-21-54237202 Fax: 86-21-64223464 1Z{~)\: Bruce Jarnot [mailto:jarnotb@api.org] {~1R shanghaihealthstudy 1Z:i!ll1r8J: 2005:-qo5 Jj 17 B 21: 50 t&{~)\: Fu Hua fY:i!: Shan P. Tsai (E-mail) 3t~: RE: Fudan University budget adjustment Dear Dr. Fu - Yes, and thank you. We received your email yesterday morning (Monday May 16), and I spoke with Dr. Tsai this morning. Shan will call you soon to consider a way that we can use these comments (including English-to-Chinese translation of the contract), and also use a temporary contract to pay Fudan invoices now. With best regards - Bruce. -----Original Message----From: Fu Hua [mailto:hfu@shmu.edu.cn] Sent: Tuesday, May 17, 2005 12:00 AM To: Bruce Jarnot Cc: 'Shan P. Tsai (E-mail)'; shanghaihealthstudy Subject: ??: Fudan University budget adjustment Pis give me a reply if you receive it, thanks Dear Bruce The lawyer of our university has reviewed the agreement of 2004-2007 and sent back her comments on it. They suggested adding 3 items to the agreement. As the statement of the sentences seems complicated, I could not translate them into English. Herewith pis find the attachment the scanned document in PDF format in Chinese. Please ask one Chinese people to help you to translate it into English. If you agree that, pis add them to the agreement and send back to us with signed one. I am sorry about that but it is an administrative problem I have to do that. SH ELL-MCCLU RG-052870 With best regards FuHua ***************************** Fu Hua, MB, MPH, PhD Deputy Dean and Professor School of Public Health Fudan University PO Box 248 138 Yixueyuan Road Shanghai 200032 China Fax: 86-21-64223464 Tel: 86-21-54237202 SHELL-MCCLURG-052871 SHS Semi-annual Report July 14, 2005 By Fudan University School of Public Health SH ELL-MCCLU RG-052872 1. Summary During the last 6 months, Questionnaire Takers interviewed 830 subjects for CC/DP Study, for an average of about 40 cases per week. The EA team visited 15 factories, gathered historical industry information and drafted a comprehensive benzene exposure historical summaries for shoe-making and textile printing industries; conducted site monitoring at 25 factories and collected 350 personal, area and bulk samples. Out of the total of 3775 Questionnaires collected so far, 3308 went through preliminary exposure assessment and the current "benzene exposed rate" remains around 7%. Due to the lack of availability and accessibility of complete historical IPHS information, Exposure assessment for the CC/DP study has shifted its focus from a case-to-case based study to sector analysis. For the ME phase I study, medical records of 1600 cases were collected and entered into an Access database. Exposure Assessment, although slower than expected due to limited factory and information access, is progressing. So far, the EA team visited 11 factories for the ME Phase I, and additional 7 factories have exposure assessment site investigations pending. No progress was made for ME phase II study because factory mangers couldn't accept consent forms. Issues, challenges and suggestions were summarized as follows: Evaluate second level questionnaires to make them more feasible and valuable Inadequate involvement of IPHS is still an obstacle against prompting the EA process. More efforts (resources) are needed from IPHS to speed up factory visit. Very limited access to IPHS database. Negotiation with CDC is necessary to get more data. Fudan investigators should be kept informed on the exposure assessment focus and strategy. More workers are needed for ME phase I study. But, it seems difficult to find information out of Shanghai. Factories couldn't accept ethical requirements of ME phase II study. A meeting is proposed to discuss factory enrollment in August. Senior occupational physicians and bioethical scientists should attend this meeting. 2 SH ELL-MCCLU RG-052873 2. General Management After dialog and interaction among the Pis of the study during the early part of the year, the Fudan EA team has worked on improving communications. Through weekly staff meetings and monthly reports to Pis, the Fudan team maintained communication with both the team members and the Pis overseas. These monthly reports not only captured progress made, but also communicated the technical questions raised by the EA team. During this period, the team welcomed two new members who joined the team to fill in gaps left by a graduation and a pregnancy. With the project deadline approaches so far, we have not lost any team members. Keeping the team together in a cohesive and motivated unit is increasingly important as we get closer to the project completion. The Fudan EA team also played a key role in interacting with IPHS. Fudan has initiated meetings with IPHS at least once a month to address issues related to data and factory access. However, keeping EA team members of Fudan fully informed and transparent on a strategic basis of foreseeing EA approaches remains to be further prompted. In addition to the "personnel management", more technical supports and team capacity building are preferably appreciated. Task should ideally assign through the group leader instead of delivering to individual team member directly. 3. Technical PROGRESS 3.1 CC and DP studies 3.1.1 Questionnaire administration Up to June 25th, 2005, 3375 subjects have been interviewed; 1885 secondary questionnaires were applied. A total number of 850 subjects, including both case and controls, were interviewed in the last half year, and of these, 484 subjects had the secondary questionnaires applied. Data collected from the Questionnaires was reviewed immediately after the collection and phone interviews were used as follow up to further clarify any questions that the QA coordinator may have. The first time pass rate is at around 89%. 3.1.2 Control selection QA has worked closely with the hospital coordinators to ensure that control 3 SH ELL-MCCLU RG-OS2874 selection adheres to the selection criteria, only 1.1 % was found being selected from the same departments of the relevant hospitals; and 2 controls (0.4%) were repeatedly selected. All of these selected controls were excluded out; and the new controls were selected according to the selection criteria. Control distribution: see the annexed table: distribution of inpatients in 68 hospitals (2002, Shanghai) vs. CC/DP controls. 3.1.3 Data entry and validation In the last six months, data entry has kept with the pace of Questionnaires Administration, only one week lag behind the interview.. The data entry error rate remained at about 2%. 3.1.4 Exposure assessment The EA team has taken on an active role to pursuing information related to the potential exposure scenarios. Main activities and accomplishment by the EA team include: Coded all cases and controls with industry coding developed during the third National Census Guideline. Completed preliminary assessments and make qualitative judgments of cases or controls that are exposed to benzene and other substances based on information on the Questionnaires. Gathered historical exposure data from IPHS or follow-up site investigations. During the last six months, the EA team visited 15 factories and collected personal, area and bulk samples. Completed summary reports and documented information collected for all cases and controls accumulated since last year. Table 1 Current status of the case distribution in CC/DP Study. Table 1 Summary of CC/DP exposure assessment (2003.5-2005.5) Preliminary exposure assessment Completed to date No. subjects that needs further follow-up by EAC No. of subjects exposed to other substances Interim benzene exposure rate (7%) Benzene exposed Benzene potentially exposed 3308 277 2631 112 121 During the last 6 months, 1228 subjects were assessed to clarify their potential exposures. 1130 of the 1228 subjects (92.02%) were identified as "non-exposed" or "exposed to other chemicals only except benzene"; 98 4 SH ELL-MCCLU RG-052875 subjects (7.98%) were identified as "potentially benzene exposed" that were followed-up for further quantitative assessment. Of these, 52 subjects were accomplished for a qualitative EA; and 4 for the quantitative EA. Although the estimated benzene exposure rate is at about 7%, the final assessment may be slightly lower. These "potentially benzene exposed" subjects are mainly from the following industries. Industry Distrbution of Benzene Exposed Cases 9% 32% [l Printing IiiI Shoe making Figure 1. The distribution of Benzene exposed subjects by industry During the last six months, the EA team has found that one-on-one matching of a subject's working place based on IPHS database has proven to be far from fully effective. Only 3-5% factories of the subjects worked can be identified in the IPHS database, and the area samples taken often do not match the work area/task or time period the subject worked in that factory. Therefore, the project is forced to further evaluate an alternative from the protocol for the retrospective Exposure Assessment strategy. A closer look at the IPHS database by industry, breaking down the database by the factors that contribute most to the exposure level - production scale and facility environment, time period, location and task could render some useful information, at least on the range of exposure level. Such information needs to be further verified through other information resources such as published literature, expert input and most important of all when possible, site investigations. The access of the whole database has been withheld by IPHS and that has hindered the effort for sector analysis. Nevertheless, the Fudan EA team has been focusing on the following areas: 5 SH ELL-MCCLU RG-052876  Continued efforts to follow up on information regarding the exposure of each individual subjects Grouped all cases from the same industry together and analyze its commonalities and difference Sought information to better understand the industrial process and job/tasks that are related to benzene exposure and gather information that could contribute to the re-construction of historical exposure scenarios. Collected over 200 Chinese literature related to the benzene exposure Visit to factories and district IPHS, worked with people who directly conducted site monitoring, interviewed service personnel, and conducted current site exposure monitoring. 3.2 ME Study 3.2.1 ME phase I 3.2.1.1 Medical records collection For 2221 cases, historical medical records from 25 factories were collected by the Yangpu Central Hospital. HistoricallH background information and monitoring data were collected from three sources - factory records, IPHS database and/or occupational hospital records. As the critical regulatory requirements for record keeping did not effectively enforced until the passage of Occupational Disease Prevention and Control Act in 2001, often historical data were no longer available. Two factories with a total of 255 cases were disqualified due to inadequate supporting records. 3.2.1.2 Standardization and data entry Before data entry, names of job titles of workers were standardized through factory managers, senior workers. Medical records from 15 of the 20 factories were double-entered per QA procedures, and validation is currently under way. 3.2.1.3 Exposure Assessment Re-construction of historical exposure levels takes several steps and the only way to reconcile historical hematological data is through site investigations. So far, 10 of the 18 factories were visited by the EA team, with a total of 250 exposure assessment samples taken at the sites. Once the data are available, the EA team associates each of the worker's historical exposures to a job location/task through a coding system, So far, re-construction of historical exposure is completed for about 300 cases from 6 6 SH ELL-MCCLU RG-OS2877 factories. 3.2.2 ME phase II Although Fudan has been negotiating with factories, no worker has been successfully recruited for ME II study. A file has been submitted to Dr Irons to help him understand the critical problems of ME II study. 4. Issues, Challenges and suggestions 4.1 CC and DP studies 4.1.1 The second level questionnaires FUSPH (Fudan School of Public Health) translated all the 63 types of occupations/jobs into Chinese. Although the second level questionnaires were used successfully in USA, the questionnaires often make both interviewer and interviewee confused and lost confidence in responding them. Very limited valuable information could be collected through 2nd questionnaire. Fewer questionnaires were used by EAC to support exposure assessment. Comments on 2nd questionnaires were collected from questionnaire administrators. The Fudan team would like to suggest that US experts evaluate current status of 2nd questionnaire usage and make them more feasible and more useful. 4.1.2 Inadequate involvement of IPHS Inadequate involvement of IPHS is still an obstacle against prompting the EA process. It was agreed early this year that IPHS staff would participate weekly EAC meeting. However, IPHS participated in only 2 EAC meetings. Field visits to 17 factories were arranged in the first half of this year. The IPHS coordinator could spend only 1 day per week for CC/DP and ME studies. Recruitment of a full-time staff, which is ideally familiar with the role of IPHSs and the trendy changes of relevant industries, is needed, so that we can visit factory under a more responsive and effective way. 4.1.3 Access to IPHS database Full access to the IPHS database is essential to the sector analysis approach. Currently, IPHS has refused to provide full access, citing complains from other study parties with which IPHS is collaborating. Actions to prompt IPHS re-engaging are under reviewed. 4.1.4 Technical supports to exposure assessment team EAC was directed to focus on "sector analysis" and to estimate the exposure level in terms of 'high', 'medium' and 'low' according to the factory size in May. The questions are: 1) how to define factory size; and 2) the factory size doesn't 7 SH ELL-MCCLU RG-052878 necessary proportionally relate to exposure level. However, no further clear and constructive guidelines have been provided by US experts, which need to be more transparent and technically supportive. Further communication between US and Fudan investigators is needed. Fudan investigators should be kept informed about the adjustment of exposure assessment strategy. Fudan investigators understand that the EA is one of the most complicated issues for SHS, and it's difficult to answer all questions at thee moment. However, we are hoping that all important decisions would be made based on scientific judgment and agreed with the Pis. 4.2 ME study 4.2.1 ME phase I study After the qualification process, only a little more than half of the cases collected for ME Phase I study will be usable. Therefore, more factories need to be recruited. The Fudan Team and Dr. Ni both explored the possibility of reaching out to other sources for the information out-side Shanghai. However, historical records were not kept in these areas as complete and systematic as in Shanghai. 4.2.2 ME Phase II Study Several candidate factories were approached but none of them could accept the ethical requirements and were willing to sign the consent form on behalf of workers. The ME II study would not be approachable unless the Ethical Committee would consider a different approach. 8 SH ELL-MCCLU RG-052879 Annexed table 1 : Disease distribution of inpatients in 68 hospitals (2002, Shanghai) vs. CCIDP controls (between Jan. to Jun. 2005) sort of disease infectious disease and vermmOSlS cancer incretionary disease,nutrition related disease, metabolic disease,immune disease blood and hematopoietic organ related disease mental disease Neurologic system disease and sense organ related disease Ciru1ation system disease Respiratory system disease Digestive system disease Urinary system disease cyesis,delivery and complication of the puerpenum dermal and hypodermis disease muscle and skeletal system disease, connective tissue disease inherent abnormality condition from perinatal period unknown of sign and symptom impairement and intoxication others number of Number of proportion( % ) Proportion ( % ) discharged patient SHS controls 12952 74460 1.90 10.92 5 0.94 82 15.36 15859 2.33 31 5.81 4448 941 27642 100827 93602 105418 40459 82255 4542 16156 4472 3461 6040 54607 43742 0.65 0.14 4.05 14.79 13.73 15.46 5.93 12.06 0.67 2.37 0.66 0.51 0.89 8.01 6.41 0 0.00 0 0.00 51 9.55 84 15.73 55 10.30 76 14.23 64 11.99 5 0.94 5 0.94 54 10.11 0 0.00 0 0.00 12 2.25 5 0.94 5 0.94 9 SH ELL-MCCLU RG-OS2880 681883 100.00 534 100 10 SH ELL-MCCLU RG-OS2881 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Wednesday, August 17,20054:06 PM (GMT) benzconsort-tc@listserve.api.org benzconsort-oc@listserve.api.org; benzconsort-cc@listserve.api.org BHRC-TC... Mid-Year SHS Progress Reports: DP/ME & CC DP ME Progress Report 07 200S.pdf; CC Progress report 07-26-200S.pdf BHRC Technical Committee (-TC) We have now received mid-year 2005 Progress Reports from both Drs. Irons (DP & ME Studies) and Wong (CC Study); pdf copies of these reports are attached for your review, and are also available on the SHS web site... With best regards - Bruce. SH ELL-MCCLU RG-OS2882 PROGRESS REPORT July 2005 I. ANALYSIS OF DISEASE PROGRESSION FOR APLASTIC ANEMIA, MYELODYSPLASTIC SYNDROME, ACUTE MYELOGENOUS LEUKEMIA AND BENZENE POISONING IN SHANGHAI, CHINA II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS IN SHANGHAI, CHINA III. EXPOSURE ASSESSMENT A MULTICENTER INTERNATIONAL STUDY Molecular Toxicology and Environmental Health Sciences Program Dept. of Pharmaceutical Sciences, School of Pharmacy Department of Pathology, School of Medicine University of Colorado Health Sciences Center, Denver, CO. School of Public Health, Hua Shan Hospital, Cancer Hospital, Fudan University Medical Center, Shanghai, China 1 SH ELL-MCCLU RG-OS2883 EXECUTIVE SUMMARY A. Overall Status of Budget Attached is an official summary of the overall budget for the year ending June 30, 2005. In April 2005, the consortium agreed to a revised budget (Appendix A). Based on this new budget, the overall status of the budget for the first half of this calendar year is as follows: We spent $1,787,330 compared to a projected budget of $2,018,301, resulting in savings of $230,971 in funds during this period (Table 1). This savings is largely due to a reduction in operating expenses at UCHSC. Table 1. Budget Summary (Reporting Period) Budgeted! Expenditures Variance 1Personnel Operating Expenses Subcontracts 1$227,260 $247,000 $1,420,103 1$235,437 $104,457 $1,359,315 ic$8,177) $142,543 $60,788 1Travel Eqmpment 1$500 $0 1$0 $0 1$500 $0 Indirect $123,438 $88,121 $35,317 TOTALS $2,018,301 $1,787,330 $230,971 !The budgeted amounts are the sum of each category from Jan-05 through Jun-05. Table 2. Budget Summary (Entire Project) Budgeted2 Expenditures Variance 1Personnel 1$2,176,813 1$1,935,436 1$241,377 Operating Expenses $1,592,787 $1,329,463 $263,324 Subcontracts $6,260,471 $5,873,620 $386,851 Travel $47,576 $9,098 $38,478 Equipment $1,560,213 $1,383,491 $176,722 Indirect $1,018,466 $880,550 $137,916 ITOTALS 1$12,656,326 1$11,411,658 1$1,244,668 1 2The budgeted amounts are the sum of each category from Dec-01 through Jun-05. Subcontract Summary (Entire Project) 1Subcontracts IExpenditures (Dec 01 - Jun 05) Fudan University $3,415,417 IPHS $167,577 SMCDC $153,004 EMBSI $1,873,555 Children's Hospital Cincinnati $264,067 2 SH ELL-MCCLU RG-OS2884 B. Budget Analysis Our projected costs for the remainder of the project are outlined in Table 3. These figures are consistent with projections from the last API progress report except that we have added the EMBSI estimated additional costs. Table 3. Projected Budget (Remainder of Project) July1 - Dec 31 Year 2006 Year 2007 ** Year 2005 IPersonnel :------------:--:---'---------:1-'- - - - - '- - - - 1Operating Expenses 1$236,350 $254,380 1$482,154 1$203,265 $396,3601_0_ _ _ _ Subcontracts* $1,264,180 1 $2,683,219 $609,595 rT--ra-ve-l-------+-I$-5-'----00------'----":I$-----'1,-00-0-'-------1"-'-$0_ _ _ _1 IEqmpment $0 $0 $0 1Indirect $127,720 $228,677 $52,849 TOTALS $1,883,130 $3,791,410 $1,015,709 1 *Subcontract figures now include EMBSI estimated additional costs. **Post-study costs 3 SH ELL-MCCLU RG-052885 Appendix A .p~tii6ilil~I> Apr '05 Budget Actual 1$ QAAr<iti!ig.i$ipi!#iii!ii... Apr '05 Budgel Actual 1$ Stil\c90li'aiiii!> . Apr '05 Budget Actual I$ Apr '05 Budget Actual IEqiijj:ilii~m> Apr '05 Budget Actual liiCljr~t> Apr '05 Budget Actual T..O....T..A...t.S..... ', Apr '05 Budget Actual 1$ I$ 1$ 1$ Dec-011 Jun-021 Dec-021 Jun-031 Dec-031 Jun-041 Dec-041 Jun-051 172,1401$ 224,8831 $ 317,6651$ 314,7031$ 230,3281$ 211,0161 $ 229,2601$ 235,4371 13,1311$ 94,4011$ 193,9901$ 158,8501$ 162,8341 $ 364,5421 $ 237,2581 $ 72,1561 123,629 1 $ 688,452 1 $ 213,291 1 $ 845,860 1 $ 565,870 1 $ 1,128,507 1 $ 948,696 1 $ 1,359,315 1 -1$ 8,4291$ 2181$ 3461$ 1051$ -1$ -1$ -I 291,568 1 $ 253,578 1 $ 354,496 1 $ 274,508 1 $ 17,000 1 $ 192,340 1 $ - 1$ -1 47,9221 $ 111,4541 $ 139,5871$ 122,9021$ 101,4471$ 148,7091 $ 120,4081$ 79,7221 648,3901$ 1,381,1971 $ 1,219,2471 $ 1,717,1691 $ 1,077,5841 $ 2,045,1141 $ 1,535,6221 $ 1,746,6301$ Dec-051 -I $ Jun-061 Post-Study thru ITotal thru Post- Dec-06IJun-07 Study 2,849,025 1 $ 1,935,432 1 $ 1,297,162 1 $ 5,873,620 $ 10,993 1$ 9,098 1 $ 1,383,490 -I $ -I 1 $ 872,151 ..$.... """""""""'''' $ 18,332,769 1$ 11,370,953 Original Budget $ 14,508,000 (J) Revised Budget $ 18,332,953 I m Increase $ 3,824,953 r r sI : () () r C ;a G) ocI.n I'V ex> ex> (J) 4 I. JCML OPERATIONS A. Progress Study diagnoses for the first 18 months of case accrual (Sep 03 - Feb 05) have been completed and 100% reviewed. During the first year a total of 740 cases were diagnosed and 732 were assigned ICD codes according to WHO and ICD-I0. The remaining 8 unassigned cases are follow-ups for the DP study. There were a total of 147 cases of AML (WHO), 152 cases of lymphoid (WHO) (i.e. NHL+ALL+CLL) and 113 cases of NHL+CLL (lCD-I0). There were 129 cases of MDS, 48 cases of AA and 20 cases of benzene poisoning diagnosed. At 18 months a total of 1131 cases were diagnosed and reviewed with 1108 ICD codes assigned. The remaining 23 unassigned cases are follow-ups for the DP study. There were a total of 269 cases of AML (WHO), 261 cases of lymphoid neoplasms (WHO), 188 cases ofNHL+CLL (lCD-I0), 192 cases of MDS, 61 cases of AA and 25 cases of benzene poisoning diagnosed. Further, a total of 400 patients were diagnosed over the past 6 months, bringing total cumulative case contact to 1531. Since January, a total of 4 cases of AA, 39 cases of MDS, 56 cases of AML, 55 cases of lymphoid neoplasms and 2 additional BP cases have been diagnosed, and a total of 137 cases remain unassigned to the study database as of the time of this writing. In addition, over the course of the project to date JCML has diagnosed approximately 40 pro bono cases for individuals, mostly children, who do not qualifY for inclusion in our studies. B. Nutritional Deficiencies An important observation is the number of hematologic abnormalities that can be attributed to nutritional deficiencies. As of June, 2005 we have identified 72 cases, the majority of which would be misclassified as AA, MDS or even AML in a retrospective study. Consequently, nutritional deficiencies are involved in roughly 20% of the potential case accrual for these diseases, rendering nutrition an important confounding factor in the study of AA and MDS. The frequency of diagnosis of nutritional deficiencies at JCML also suggests that this represents an important public health issue in Shanghai. Professor Fu Hua has agreed to take responsibility for preparing an analysis of the influence of nutritional deficiencies in hematopoietic disease in Shanghai. C. HIV Serology Testing We have encountered difficulties in implementing approved changes to the protocol for directly determining the rate of HIV seropositivity in our lymphoma cases. This is due to a number of logistic problems, primarily the fact that the majority of lymphoma cases, especially low grade lymphomas, are outpatients who are reticent to provide a blood sample for procedures not directly related to the diagnosis of their condition. Other outpatients are not willing to return to the hospital for additional blood work after diagnosis. Alternatively, screening for HIV is becoming far more commonplace in Shanghai, and participating hospitals have agreed to share HIV serology data previously obtained from IC'd subjects. Nevertheless, an effective mechanism for doing this on a routine basis has yet to be implemented. In contrast to the issues related to sample collection for NHL, all hematology cases, including ALL and CLL cases, 5 SH ELL-MCCLU RG-OS2887 diagnosed at JCML have been tested for HIV. To date, no confirmed cases of HIV have been identified in these subjects (N)650). Independently, the NHL subtypes diagnosed in our patient population are not consistent with immunodeficiency-associated lymphoid disorders. Therefore, although we have only a fraction of direct measurements on NHL cases, we believe that it is very unlikely that HIV constitutes a significant confounding factor for any of our studies. II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS A. Molecular Epidemiology Phase 1 The goal of the molecular epidemiology (phase 1) study is to: (a) study retrospective benzene exposure levels vs. blood counts present in worker exam records, and (b) identify candidate factories for subsequent phases (e.g. 2A, 2B) of the study. Through the leadership of Dr. Ni, excellent progress has been made in abstracting hematology counts from physical examination data at a number of facilities. Over 1600 cases have been collected and entered into an Access database from 17 facilities. Not all of these records will qualify for the final study, since some cover only one year of readings, while the molecular epidemiology study requires at least two years (and preferably more) to be able to study potential effects on blood counts longitudinally. A potential issue for the Phase 1 study is whether the records that have been abstracted are representative of the workforce. In some preliminary factory visits, it was noted that records for workers with 'normal' blood readings were stored at one location, while records for workers with 'abnormal' blood readings could be stored separately. Dr. Ni believes that this did not apply to the cases in the Yang-Pu hospital, where most of the records were collected. Nevertheless, frequency counts for 'normal' and 'abnormal' values of different blood parameters will be examined by factory and time period to ensure that this is the case. Exposure assessment for the factories selected has been proceeding at a steady pace. So far, the EA team has visited 10 of the 17 factories, and 7 factories are awaiting a site visit from the team. The aim of these visits is to collect information beyond that which may be present in the IPHS database. This is needed to reliably link certain jobs/factory locations with appropriate retrospective data. In addition, the EA team has performed screening assessments with rapid-detecting instruments, consisting of over 250 measurements. The results of the initial assessments have been mixed: in some sites no records of benzene exposure can be found, while others have yielded good retrospective records. In other sites no current benzene exposure can be found, in others relatively low levels can be detected. So far, over 300 cases have useable exposure and blood data. We are actively working on exposure assessment and assessment of the hematologic data to assess how much useable data is present in these records. While these efforts proceed, it seems reasonable to assume that less than half of the 1600 records will ultimately contain useable blood and exposure data. A 6 SH ELL-MCCLU RG-OS2888 coordinated effort is underway to identify suitable factories outside of the Shanghai area that might be used to increase the number of workers in the Phase 1 study, while also identifying sites for Phase 2A. B. Molecular Epidemiology Phase 2 A total of 42 factories have been visited in an effort to select appropriate facilities for Phase II studies. Extensive area and personal sampling has been performed in three facilities with 984 area samples analyzed with mean airborne benzene concentrations of benzene ranging between 0.01 and 326.7 ppm. A total of 231 workers have been recruited to the Phase IIa study. Over the past year, the ME study has encountered a number of challenges which have impacted on its progress and resulted in some mid-course adjustments. First, our success in gaining access to acceptable study sites has been very limited. Out of 42 factories visited only 5 were considered to be appropriate for initial Phase IIa activities and only 3 have been extensively analyzed. Moreover, recruitment of workers to Phase IIb, as originally designed has proven to be problematic (N = 3). In addition to the obvious ramifications of documenting high benzene exposure in the workplace along with health effects, we have encountered a variety of difficulties in obtaining the cooperation of management in many facilities. The reasons for this are many and varied. Some frequently encountered problems are culturally based: First, in state-run companies market place competition has resulted in considerable financial stress, workers are at risk being laid-off and the anxiety is high. Therefore, management typically wants to avoid anything that may trigger trouble and reactions from their workers. Second, our use of informed consents and pledge to compensate workers for any problems arising from participation in the study stands in sharp contrast to similar recent or ongoing studies that do not acquire consents or offer any forms of compensation, thereby posing an indirect threat by example. Both local occupational physicians as well as Professor Xi have informed us that it is unlikely that this issue can be resolved without major changes to our ME informed consent (IC) procedures. Accordingly, I have asked a committee comprised of senior occupational physicians from local hospitals, the Vice Director of the CDC Physical Examination Center, Dr. Ye Xibiao, Lv Ling (JCML's lead occupational physician) and Professor Fu Hua to review the problem and to make suggestions for changing the IC procedure. These issues notwithstanding, we identified factory workers with benzene poisoning, admitted them into hospital in Shanghai, and recruited them to the DP study. This strategy was inculcated in the original approved study design and has resulted in characterization of a case series of 23 individuals with persistent dysplasia following prolonged benzene exposure and for which we have robust exposure assessments. These cases also contribute quantitative exposure assessment data to the CCIDP EA matrix (see below). To date, we have identified approximately 30 such individuals using this mechanism. In addition, we have modified the original protocol by adding peripheral blood benzene metabolite and urinary sPMA analyses to Phase IIa as opposed to limiting metabolism studies to Phase IIb. To date, we have measured benzene metabolites in the blood of 103 exposed workers, conducted pre- and post- shift analyses of urinary sPMA 7 SH ELL-MCCLU RG-OS2889 in 104 workers and have integrated hematology, exposure, metabolite and urinary sPMA data for 64 workers. In addition, utilizing PCR-RFLP methods, we have conducted preliminary genotyping of CYPE2E1, NQOl-465CT and -609CT, MPO-463GA, and GSST1 polymorphisms on all 231 Phase IIa subjects. III. EXPOSURE ASSESSMENT A. Introduction The past 6 months have witnessed major developments in the EA process which are outlined below. This report represents the collective effort of a large group of individuals including the Fudan SHS Exposure Assessment Team under the direction of Prof. Fu Hua, Dr. Tom Armstrong and Yimei Zhou of EMBSI, with input from Dr. Schnatter and Prof. Irons. B. Exposure assessment strategies and goals The EA strategy originally designed for the DP study was adapted to all SHS hospital based studies upon the recommendation of the SRP in 2001. The primary goal of the CC study is to ascertain whether benzene exposures or other variables (e.g., viruses, nutritional deficiencies or other chemicals) are associated with certain diseases (e.g., NHL). Ordinal range assessments (no, low, medium, high exposure) or where feasible, quantified ranges such as <0.4,0.4 to < 4, 4 to 40 and> 40 mg/m3 support these study objectives. This tiered approach (Figures 2 and 3) was originally outlined in the study protocol and endorsed by IH SRP members. Quantitative benzene assessment, which is the EA strategy employed for the ME study, is targeted for a fraction of the CC/DP subjects, and is dependent on feasibility. In the ME study, factories are selected based on good EA and health effects records and a willingness to participate in extensive concurrent personal and area monitoring activities. Thus, the detailed quantitative EA analysis performed in ME supplements and reinforces EA efforts in CC/DP. The timeline for EA is depicted in Figure 4. The integration of qualitative and quantitative EA processes is targeted for the second quarter of 2006 when validation and assembly of the final CC/DP EA matrix is slated to occur. The assignment of final benzene exposure will then follow. c. Progress 1. Data collection During the last 6 months, Questionnaire Takers interviewed 850 subjects for an average of about 40 cases per week. The EA team conducted site monitoring at 25 factories and collected 350 personal, area and bulk samples. A total of 3375 questionnaires have been collected to date with 3308 having completed preliminary exposure assessments (EA) for substances of interest, including benzene. A total of 1885 secondary questionnaires have been administered, including 484 during the last 6-month period. Data collected was immediately reviewed and telephone interviews conducted to clarifY any remaining issues. Qualitative EA are now progressing at a rate consistent with subject accrual (See Figure 1). Semi-quantitative and quantitative exposure 8 SH ELL-MCCLU RG-OS2890 assessment (EA) of benzene requires more detailed data assembly, and the time line on this effort naturally lags case accrual. Nevertheless, these analyses are on schedule for completion in conjunction with detailed benzene EA which is slated for third quarter 2006, for the cases accrued to that point. Initial projections for benzene-EA were based on predictions of a caseload of 500 cases per year and an expected prevalence of 10% benzene exposed in the study subjects. The caseload is approximately 50% higher than expected and the prevalence of benzene exposed subjects is about 7%. Exposures other than benzene were assigned in over 2600 instances. The studies by design evaluate exposures to a range of risks other than benzene, since exposures to other hazards relevant to the diseases of interest may be indicated in a subj ect' s work and life histories. EA team members continue to close the gap on earlier shortfalls in EA assessments and progress is now meeting the expectations of the EA Coordinating Committee (EAC). Nevertheless, unanticipated challenges have required additional staffing, and we continue to experience a shortage of qualified EA personnel. Therefore, efforts are underway to recruit additional experienced staff. Through the first half of 2005, 93 work site inspections (CC/DP and ME) have been completed. These work site inspections included extensive current exposure monitoring: 4300 UltraRAE screening measurements of benzene concentrations 2150 area samples (20 minute breathing zone by IPHS protocol) 1070 personal benzene exposure samples Additional site reviews are planned. 2. Exposure analysis for the CC/DP studies We have experienced limited success finding exact matches for factories with exposure data corresponding to time periods relevant to subject work histories. Many factories are closed and were not previously monitored by IPHS. Some subjects are from areas of China remote from Shanghai. Review of completed assessments using exact match or limited surrogate site data showed divergent results for apparently similar work histories. Therefore, the industry sector analysis previously described in the study protocol is being emphasized for providing quantitative data to support the final benzene EA. Sector analysis was further developed in April, with a pilot test conducted in May to evaluate the capabilities of performing sector analyses as part of a comprehensive EA strategy. The study focused primarily on the shoe industry and on a segment of the rubber industry. The exercise involved: Sorting available IPHS data for the industries of interest Sorting the data into sectors within each industry Adding supplemental task categories (not part of the IPHS database) based on sample location descriptions 9 SHELL-MCCLURG-052891  Qualitatively evaluating the frequency-concentration distributions of the sector, by task and time period Calculating preliminary summary statistics for the identified sector, task and time categories As a result of this exercise for the test industry segments, sector analysis was determined to be a useful approach for evaluating other key industrial segments found in subject work histories, and is being integrated into an overall collaborative effort with IPHS. The sector analysis evaluation yielded insights that led to further research efforts that are currently underway. One main point from the pilot study is the need for additional coding based on area descriptions given for the samples in the IPHS database. The additional codes are needed to separate the data concerning where people worked, what tasks were done and by era. The additional coding will reduce heterogeneity in the data sets thereby allowing more precise exposure assignments. This additional coding and analyses will be conducted in collaboration with IPHS. The main stages of the CC/DP process, with responsibilities and progress dates are shown in Table 4. It is important to recognize that until the EA matrix is completed, the process is dynamic and iterative, with the methods and degree of reliance on individual information sources differing for individual sectors. Several different sources of information are being used and periodically reviewed, and previous assessments are continually being compared with ongoing ones. For approximately 13% of the CC/DP subjects qualitatively categorized as benzene exposed, quantitative analysis has been successfully completed as part of EA in the ME study. These quantitative assessments are based on current personal exposure measurements, current area concentration measurements, detailed compilations of factory changes over time that modulate exposure, use of retrospective exposure estimating techniques, and use of past IPHS monitoring data. This has resulted in a detailed exposure matrix for these subjects. Additional publications based upon this work are in preparation. 3. Changes to the data collection process Many of the second level questionnaires were found to be of minimal value so the set has been reduced to 23. An additional summary of key task information (e.g. task description, materials used, frequency and duration) is being provided on a "key data summary" card to better prompt the staff during questionnaire interviews. Additional question-coded data recording sheets are being considered since the primary questionnaires do not always provide sufficient writing space for detailed answers. 4. Initial screening, qualitative assessment and relative ranking The EAT and EAC have prioritized the completion of qualitative assessments and relative ranking of the subjects for benzene and the other exposures. This provides a basis for linking the subject's work history to the project exposure assessment matrix. Part of the review includes seeking current access to the work place for current 10 SH ELL-MCCLU RG-OS2892 monitoring and evaluation of changes in the operation relevant to the time the subject worked. 5. Collaboration with IPHS Collaboration with the Shanghai IPHS has been enhanced and restructured to provide an integration of database, factory site evaluation and sector information. This involves close interaction with IPHS District staff in order to conduct a comprehensive analysis of a single district, Yang Pu, that will serve as a centerpiece for the development of tools for validating individual data sets. Work with the District staff includes verifying data in the database, and completing current monitoring for factories operating in the District that coincide with study subject work histories. This collaboration provides additional resources to further code data and to develop summaries for industrial sectors important to the subject work histories. Reviews of the CC/DP exposure assessments have been underway for the last year, and will be expanding in number and depth as the EA matrix supporting materials and their translations reach completion. It is proposed to have members of the SRP with expertise in EA participate in a review of exposure matrix in the second half of 2006. 6. Analysis of the Chinese EA literature Professor Liang has been asked to complete the summary and analysis of the Chinese EA literature, including categorization of articles by quality, for use on the EA process. Another important aspect of the analysis that is underway is the preparation of summary reports that outline trends impacting exposure potential for key industries. An important part of this exercise is a summary of the benzene composition time trends for key materials (e.g., glues, solvents, paints, gasoline). This is an important and significant undertaking which is needed to complete the integration of EA processes into a final exposure matrix. 7. Management Continued dialog and interaction among the Fudan and Western EA investigators and Consortium Committees has resulted in some streamlining of the EA committee process to improve organization and communications. The purpose of the EA Coordinating Committee (EAC) is to discuss progress and identify problems that have occurred during the past month and identifY goals and approaches for the EA team (EAT) that will be followed for the next month. The EAC is under the direction of Professor Fu Hua and includes Tom Armstrong, Zhu Surong (IPHS) and Yimei Zhou (interpreter). The EAC reports directly to Dr. Irons. The EAT, which is responsible for day-to-day EA operations, holds weekly staff meetings which are co-chaired by Ye Xibiao and Yimei Zhou. The purpose of these meetings is to manage EA operations, provide a list of weekly action items and to identifY issues that need to be taken to the EAC. During the past 6 months, the team welcomed two new members who joined to fill in gaps left by a graduation and a pregnancy. Additional staffing efforts are underway to identify an experienced individual with both IH training and bilingual language skills. 11 SH ELL-MCCLU RG-OS2893 Figure 1. June 2005 CC/DP EA Status 5000 4000 3000 2000 1000 (J) I m r r sI : () 0 Case recruitme nt Data Entry Benzene Final Final Prelim EA Exposed Other Exp Subjects Benzene Exposed () cr iii! 06/05 Actual 3375 3335 3308 233 2631 ;a D 06/05 Planned I 3080 2920 2900 290 5300 530 G) I 0 c..n I'V ex> <D ..j:::o. 12 Figure 2. CC/DP Exposure Assessment Process Overview Hospltal.recrulttnent,.cases.or 6p1. (1 OJY~i1!1") .AM. (50N~"'I") MOS~(60N~~i) A.MI.... (120/yeal"),.NHI.J.(1201year) 11(JB()!Y~r)5/day TWo .1"II~t~h~d. ~b t"lt~61 ~ seleetedpercase: nitial.eKPQ$Uteaili5e::i5melit "workhistorv, ~IPHSdatabas. "f~jlltYrj(:)l"d!l, .Oth~t' ClarifyofVerifY.& charactertze main.exposures (J) I m r EXPQ$Ur .t'"ofHlitrudi>f'I .hj$tQrir1'I~~$I.II"~II'l~l"It$, l1i~~ry.Qfh~rl9~$ Expo!:iUr:$urv:Y$ ~. fat ility sum rn an's s:r I irl.l'I1~t hQd $, f21i liti ~$, .1'I12lt~rial$, .d. "W(jl"k~1" Ql'"lil.ll"l'"Qgi1!t~~"PQ$L.I~ I'rJQllitQlil"lQ I"~t t'Q$p~ti 't't!t!!:tim21tiQri ":'\il"$:'\mpl~5: () physical!"ec!"etlfiori ~ biQIQgical.rr]onitQnhII () r C ;a G) oI c..n 13 I'V ex> c<.D.n Figure 3. Case Control Studies Tiered EA Design: Expectation of Fewer Subjects Completed at Higher Tiers / \/ ' ~~... ...................... ................................................................................... ................................................................................................................................................. ....................................................... G'{/4~.~>I"IC3>/eO/-A,. ~<~7/ ~/7 (J) I m r r sI : () () r C ;a G) oI c..n I'V ex> <D (J) e. g.,. -<0.4,0.4. to-<4~ 4tQ <40ar"lq >40.mgJr"I13 e.g~,No,Lbw, lVIE!dil.lm,Higl'l ~\",\ee-.J.ve~y.~~r:C~FS~e__6_$_e\_eP{\t-<;\e\ ~<;96?f0 14 .101 111 a:Uj t.llf.t 10 ~:'llel Figure 4. CCIDP EA Path Forvvard Ii')'" '105 V(l6 1,0; 60' LahrratHjI.1I111 S:11I1l~ Still!-l'll. Desij)ll. Slilff R~'lUi'nl'!lIt. TlilillilljJ. ~IHI Pil<Jt Stlldi'S IillJ [I~tdPaliflll RecllliUlIIII, n,lt,] ':.nllectiOll. EIlny. Tlam.I<lti() II, E:'IlMilll" ASS!fS31l1IlI, .lml Qil/O( 1119 ~;t,lti31i ..,~I AII,lIpis. ne" (> It .) 11<1 P" blk.~li ft 11 CCiDP EA TIMELII'JE ... QlJeSIi(nll::1ipO!=,.q::1t21.entl'y,..qU<lli:y.GI~E!cks .. ................-~-...- ~.....~-."'~-....~....-...--'~ ............:-;.,... Qualitative ".lid Quantitati'le Benzene Exposure Data C(;)lIectiol1 Procuses fl. IPHS collaboration data !:ompilation, anaIY5e"'i-1_~_ _ _""""'" ;,md summariee; by indUstrial sed()r b Site Ins r-ecti ons, ::LltTl8rt m88SLlrStT snts, rl8r-orts C. Expert Re ports ndu stry Trelljs b~I sector d PLblished literature summ~rie~ by sector CC/DP EA Revie\t\is (J) I m r .............................t'''.,...,,, r s: ~I U .P...I..E...x...t..e..r..n...a..l...R."''e1v_.i/e"",,*:. () () r C ;a G) oI c..n I'V ex> <D -.....J 15 Figure 5. CC/DP Exposure Assessment for PROBABLE "BENZENE" EXPOSED Multiple Lines of Investigation and Information QUESTIONNAIRES Primary~ Secondary '.11"..... I'--------------.l.-/-> L - -_ _ _ _ _ _ _ _ _---' INDUSTRY,. JOBS, MATERIAL S, TASKS~ FREQUENCY DURA.TION t=:-::~-::J Compilation. analyses. summaries by sector - Benzene (Toluene, Xylene) "1 INDUSTRIAL SECTOR HISTORY REPORTS Industry & Technology, Solvents. Paints, Gasoline Compos ition CHINESE LITERATURE SUMMARY r-. . . . . . . . . ,,".................................) ,"",'/ "SECTOR" .ANALVSIS & STA.TISTICAL SUMMARY, ~/.'.r..... .../. - ...._/__ ,\,/l /~. .~/- /~- ,Y0""'.J"- LINK WORK HISTORY, .JQia; (J) I CURRENT MEASUREMENTS m r r (ARISA 8;.PISR.SPNAL) FUDA.N.EA. TEAM.SURVEYS sI : for.ME.&.CC.,.OP () () r C ;a G) oI c..n I'V ex> <D ex> 16 Table 4. Exposure Assessment Processes & Responsibilities for CC/DP Study I STEP I WHO Questionnaires - primary and secondary Questionnaire Administration (QA) Industry/job/materials/taskifrequency/duration (key data for EA and QAldata entry/EAT follow-up planning) Industry codes assigned (to group work histories for consistency and EAT follow-up planning) Translations of key information to English External resources Task descriptions (essential to link to IPHS area descriptions) EAC Task coding (to group work histories for consistency and follow-up EAC planning) Link work history/taskiindustry/time to reference data via EA matrix EAC/EMBSI I WHEN On-going On-going On-going On-going On-going 4Q 05' 06' I Access to IPHS data base Data extraction Industry coding (code system as for the work histories) Key Tasks and time periods summaries Time/task coding I Translation I Statistical analysis of IPHS data I PIs IPHS/Fudan EAT IPHS/Fudan EAT EAC EAC I External resources I EMBSI I Continuing On-going Existing/verification 3Q 05' 4Q 05' I 4Q 05' I IQ 06' Chinese literature searching/gathering (qualitative insights, Professor Liang Youxin 3Q 05' quantitative information to supplement IPHS database) Literature summary Professor Liang Youxin 3Q 05' Industry coding FudanEA 3Q 05' I Translation I External resources I 3-4Q 05' (J) Exposure assessment by time/sampling objective EAC/EMBSI I m r r Current site EA IPHS/Fudan EA sI : () Preliminary EA of CC/DP cases to plan follow-up actions and set EAC investigation objectives, including site ea goals () Industry and task coding of the current data to facilitate is use including I EAC r C I comparisons to IPHS data ;a 4Q 05' On-going On-going j4Q 05' G) oI c..n I'V ex> <D <D 17 I Translation I I Expert reports - summary ofindustry, technology, time variations Translation I External resources I I EAC, ad hoc advisors (e.g, IPHS) External resources IOn-going I I 4Q 05' 4Q 05' Consistency check I Project time/industry/task exposure matrix EMBSI j EMBSIIFudan EA 2Q 06' j3Q 06' Final exposure assessment External EA review I Final report EMBSllead, Fudan support Fudan EAlEMBSIIExternal experts I EMBSIIFudanilPHS 2 - 4 Q 06' 4Q 06' I 1Q 07' EAT = Exposure Assessment Team. Responsible for initial screening and for field investigation work, including investigation of workplaces for current exposure sampling and historical information for the subject work history. The EAT is under the direction of the EAC. EAC = Exposure Assessment Coordination Committee. Professor Fu Hua, Zhu Surong, Dr. Tom Armstrong, Yimei Zhou (interpreter). ~ I m rr- I ~ oo r- C o ;CI0) 18 (n ~ > C) C) From: Sent: To: Subject: Attach: Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> Sunday, July 24,20057:29 PM (GMT) Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Donald M. Burnett PhD (E-mail) <burnetdm@bp.com>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail)<russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SCC-CF-SS <sc724012@shell.com>; Colletti, Sarah J SCC-CSEA <sarah.colletti@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com>; Brian Doll (E-mail)<brian.e.doll@exxonmobil.com>; Michael Johnston (E-mail)<Mike.dJohnston@ConocoPhillips.com>; Twerdok, Lorraine (E-mail) <twerdokl@api.org>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com> BHRC committe Chairs Call - July 22, 2005 - Minutes July 22 2005 Committe Chairs Conference Call - Draft Minutes.zIP ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SHELL-MCCLURG-052901 Benzene Health Research Consortium - Committee Chairs Conference Call Minutes - July 22, 2005 Participants: Committee Chairs Patsy Clegg, Shell, Oversight Chair Jennifer Galvin, ConocoPhillips, Technical Chair Lynn Russo, ExxonMobil, Communications Chair Stuart Cagen, Budget Chair Additional Participants Mark Fitzsimmons, Steptoe and Johnson Brian Doll, Oversight Vice Chair API Staff Lorraine Twerdok Antitrust: Lorraine Twerdok Oversight Committee Update: Patsy Clegg Response to Mehlman letter sent Budget Committee: Stuart Cagen 2Q05 Financial report will be ready for Aug 11 call/meeting Communications Committee Update: Lynne Russo Annual meeting opening and closing remarks to be done in house Provided Jerry Rice a list of potential invitees to SHS Symposium on Nov 4,2005 Technical Committee Update: Jennifer Galvin No update API Update: Lorraine Twerdok All sponsors have signed contract amendment University of Colorado grant amendment will go out July 25,2005 Working on Fudan University and Applied Health Sciences contract amendments Possibility of financial audits of investigator organizations on agenda for August meeting List Serve change: change "Principal Investigators" to "Investigators" AOB Aug 11 call: focus on financial report Aug 11, 17, or 18 meeting: ConocoPhillips in Bartlesville o Agenda to include: Contracts 2Q05 financial report Annual meeting Symposium Potential audit of grantee/contractors SRPIERP Shanghai visit SH ELL-MCCLU RG-052902 Next Call: September 1, 9 AM EDT SH ELL-MCCLU RG-052903 From: Sent: To: Cc: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Monday, August 22,20053:42 PM (GMT) Benzene OC listserve (E-mail) <BenzConsort-OC@listserve.api.org> Benzene consort comm (E-mail) <benzconsort-cc@listserve.api.org>; Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org> Minutes from BHRC OC Aug. 18 meeting BHRC OVERSIGHT COMMITTEE MEETING MINUTES August 18, 200S.doc To BHRC Committee Members- Attached, courtesy of Russ White (thank you), please find the draft minutes from the BHRC meeting last week. Please send any comments or corrections directly to Russ (russellwhite@chevrontexaco.com) by Tuesday, September 6, 2005. Regcwds, La VYCl LV\,e ***************************************** Lorraine E. Twerdok, PhD., DABT Manager, Health Sciences Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street, N.W. Washington, DC 20005 tel: 202-682-8344 email: twerdokl@api.org fax: 202-682-8031 SH ELL-MCCLU RG-052904 BHRC OVERSIGHT COMMITTEE MEETING DRAFT MINUTES August 18, 2005 Attendees: Patsy Clegg (Chair), Shell Chemical Bruce Jarnot, API Lynn Russo, ExxonMobil Brian Doll, ExxonMobil Mike Johnston, ConocoPhillips Jennifer Galvin, ConocoPhillips Russell White, Chevron Lorraine Twerdok (by phone), API Mark Fitzsimmons (by phone), Steptoe and Johnson Action and Agreements: 1) The Oversight Committee approved the 2Q05 budget report with the following changes; (Lorraine to) a. Delete word "slightly" and ""(APCO)" from Text Summary worksheet. b. Add interest returned from UCHSC to Income worksheet. c. Project future income from interest on Income worksheet but don't add interest income to any cost center. d. Reconcile income on Invoice Detail worksheet with Executive Summary worksheet. e. Revise income line on Executive Summary worksheet to reflect new invoice/payment schedule. 2) Patsy to add agenda item to future OC meeting to discuss when the BHRC will sunset. 3) Patsy to add agenda item to future OC meeting to discuss the BHRC position as to whether individual company requests for information from consortium counsel should be billed to the consortium. 4) The OC decided to initiate routine, "not for cause", financial audits of UCHSC and AHS by API for grant funds received for SHS. API will submit an audit plan including scope and timing to the OC in September. The audits must be done by year end 2005. 5) Jennifer and Bruce will contact Dr. Rice to discuss his recent invitation to visit Fudan University to discuss the laboratory. They will advise Dr. Rice to contact Dr. Irons to more fully understand purpose of visit and consider expanding purpose of visit to review other aspects of SHS. This may require the assistance of other SRP members. 6) The OC agreed to limit the mailing for the General Annual Meeting (GAM) to business logistics (agenda, directions, etc.). The information will be e-mailed to invited attendees and also paper mailed to Chinese investigators. This information will be added to the SHS website and a reminder sent to those people who have not already booked a room at the Ritz Carlton. 7) Jennifer and Patsy to develop agenda for Investigator/Sponsor meeting at the GAM. 8) Jennifer to "moderate" closing plenary session which should include fifteen minutes for Dr. Irons. 9) Lynn to make sure a room is available for Sponsor representatives from 11 to 3:30 at the GAM. 1 SH ELL-MCCLU RG-052905 10) Jennifer and Bruce will clarify timing and structure of presentations with the speakers (30 minute talk, 15 minutes for discussion). 11) Lynn will check with the Ritz Carlton about having a reception there on Wednesday and moving dinner at the Peking Gourmet to Thursday. 12) The OC decided that no GAM summary was needed. 13) The OC decided to invite business sponsors to the SHS Benzene Symposium at Georgetown University. 14) Lynn will call ORC to seek a recommendation on which OHSA representatives should be invited to the Symposium in addition to any ORC members who would like to attend. 15) Lynn will draft a "1-pager" for the Symposium to help attendees understand why the SHS study was initiated and the overall structure of the study. Other handouts for the attendees should include a list of the investigators, their titles, and role in the SHS. Name tags should be provided to all attendees. 16) Bruce will contact Dr. Rice and recommend that the Symposium finish earlier to optimize participation. To help reduce the time, the session on the "Diagnostic Laboratory" could be a short part of Dr. Iron's other talk. The OC suggests that the Welcome session be 10 minutes for Dr. Rice and 20 minutes for Patsy to discuss the Sponsor's perspective. 17) The OC decided that no Symposium meeting summary was needed. 18) Jennifer will ask Mike Bird to contact Dr. Irons to; 1) determine his understanding of the distribution of the semi-annual reports and ask him to directly copy other Pis in the future, 2) remind him that publication submissions should go to the SRP and Sponsors per the protocols for Sponsor informational purposes, 3) please add a section to his semi-annual reports to include "papers in progress" (in-progress, submitted, accepted, published), 4) to please call Otto Wong to discuss recent progress made on the EA part of the SHS. 19) API to set up OC conference calls in mid-September and mid-October. Draft Agenda BHRC Joint Committee Meeting August 18, 2005 Terrace Room Private* Frank Phillips Tower ConocoPhillips Bartlesville, OK Conference call link: Dial: 1-770-765-9147 Pin: 2026828319# TIME** 7:30A 8:00A 8:05A 9:00A 9:15A 9:30A ITEM Continental Breakfast Welcome Assignment of note taker Antitrust & establish OC quorum 2Q05 Financial report - OC review/approval Contract/grant update Contract/grant audits SRP/ERP study site visits Annual meeting planning Logistics Update Agenda LEAD Patsy Clegg Bruce Jarnot Lorraine Twerdok Brian Doll Jennifer Galvin Lynn Russo Jennifer Galvin 2 SH ELL-MCCLU RG-052906 10:15 A 10:30 A 11 :00 A 11:45 A 12:15 P 1:15 P 1:30 P 2:30 P 2:45 P BREAK Continue annual meeting planning Symposium planning update Logistics Agenda Annual meeting/Symposium summaries LUNCH Communications Committee Update Technical Update Exposure assessment Case Control study DP&ME Review decisions/action items AOB Schedule next call/meeting Adjourn Bruce Jarnot Jennifer Galvin Patsy Clegg Lynn Russo Jennifer Galvin Note taker All Patsy Clegg * See building #3 on Bartlesville City Map; meeting room subject to change (may move to smaller room) ** Central time; all times approximate Attendee's names and affiliations have been forwarded to COP; the building guard will have this list to permit access 3 SH ELL-MCCLU RG-052907 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Thursday, July 28,20055:13 PM (GMT) Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org> Benzene OC listserve (E-mail) <BenzConsort-OC@listserve.api.org> BHRC-TC... ConfCall *tomorrow* Fri 29 Jul, 2:00pm EDT CC Progress report 07-26-2005.pdf BHRC Technical Committee (TC) - On short notice, we have scheduled a TC Conf Call on Friday (tomorrow), July 29th at 11 :OOam Eastern time... AGENDA -- Develop process for engaging Principal Investigators (Pis) & other SHS investigators -- Review of CC Progress Report from Dr. Otto Wong (attached pdf) -- Possible SRP review of SHS protocols versus progress to date? -- Possible SRP review of SHS EA protocol versus current EA plan? -- Schedule TC Budget Subcommittee call to review 202005 Financial Report -- Other items? CONFERENCE CALL Date: Fri, 29 July Time: 2:00pm Eastern (1 :OOpm Central, 11 :OOam Pacific) Dial in: 1-770-765-9147 PIN: 2026828319# Thank you! Bruce. SH ELL-MCCLU RG-052908 From: Sent: To: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Wednesday, July 6, 20055:51 PM (GMT) Benzene OC listserve (E-mail) <BenzConsort-OC@listserve.api.org>; Benzene consort tech (E-mail) <benzconsort-tc@listserve.api.org> BHRC-OC/-TC... PIs review by 7/08 - minutes from recent conference calls June 27-9 meeting minutes. doc BHRC Oversight (OC) and Technical (TC) Committee Members - Lynn Russo kindly provided draft summary minutes (attached) from the most recent series of OCITC conference calls. Please review content and participant lists for accuracy, and reply to me with any changes or comments by close-of-business Friday, July 8th ... Thank you - Bruce. June 27-9 meeting minutes.doc -----Original Message----From: Iynn.b.russo@exxonmobil.com [mailto:lynn.b.russo@exxonmobil.comJ Sent: Wednesday, July 06, 200510:15 AM To: Lorraine Twerdok; Bruce Jarnot Cc: mfitzsim@steptoe.com Subject: meeting minutes The Oversight and Technical Committees meeting minutes from our series of short phone calls are attached below. Mark F. has reviewed them so they are ready to go to the committees for review. Please ask that folks check the participant lists; I'm not sure I got all that right. (See attached file: June 27-9 meeting minutes.doc) Lynn Lynn B. Russo ExxonMobil Downstream Public Affairs Phone: 703-846-2500 Fax: 703-846-4169 Email: Iynn.b.russo@exxonmobil.com File: June 27-9 meeting minutes.doc SH ELL-MCCLU RG-052909 Oversight and Technical Committees Meeting minutes Joint conference calls June 27, 29 and 30, 2005 Participants June 27 Don Burnett (BP) Stuart Cagan (Shell Chemical) Patsy Clegg (Shell Chemical) Brian Doll (ExxonMobil) Jennifer Galvin (ConocoPhillips) Bruce Jarnot (API) Mike Johnston (ConocoPhillips) Lynn Russo (ExxonMobil) Jim Tilson (ConocoPhillips) Matt Todd (API) Lorraine Twerdok (API) John Wagner (API) Russ White (Chevron) June 29 Anita Balaraman (Chevron) Steve Bowes (ExxonMobil) Michael Bird (ExxonMobil) Bryant Bremer (ExxonMobil) Don Burnett (BP) Stuart Cagan (Shell Chemical) Patsy Clegg (Shell Chemical) Brian Doll (ExxonMobil) Jennifer Galvin (ConocoPhillips) Bruce Jarnot (API) Mike Johnston (ConocoPhillips) Lynn Russo (ExxonMobil) Shan Tsai (Shell Oil) Lorraine Twerdok (API) John Wagner (API) June 30 Anita Balaraman (Chevron) Steve Bowes (ExxonMobil) Michael Bird (ExxonMobil) Stuart Cagan (Shell Chemical) Patsy Clegg (Shell Chemical) Brian Doll (ExxonMobil) Jennifer Galvin (ConocoPhillips) Bruce Jarnot (API) Lynn Russo (ExxonMobil) Zachary Wong (Chevron) Note: A joint Oversight and Technical Committee meeting was scheduled for June 27; because of the time restrictions of many participants, the meeting agenda was not completed in the allotted hour. The committees reconvened on June 29 for an hour and on June 30 as well. Before all calls, Patsy Clegg called the meeting to order, did a roll call of participants, and determined there was a quorum. She noted on the June 30 call there was not a quorum for financial actions. Before all calls, API's antitrust guidelines were reviewed (by John Wagner on June 27 and 29 and by Bruce Jarnot on June 30). SHELL-MCCLURG-052910  Lorraine Twerdok summarized the status of company signatures on the consortium agreement amendment (to reflect budget revisions) and reviewed the status of invoicing and payments. Lorraine Twerdok reported revised agreements for the Principal Investigators reflecting the new budget totals would be issued as soon as all amendments had been received at API. Jennifer Galvin and Bruce Jarnot reported on the SRPIERP discussion of possible visits to Shanghai. With the annual meeting having been moved to Virginia from Shanghai, they have written the Oversight Committee about visiting Shanghai at another time. Jennifer Galvin, assisted by other Technical Committee members, reported on the conference call they had on Friday June 24 with some of the Investigators (Otto Wong and Tom Armstrong). The group discussed logistics (location, timing) of the symposium Jerry Rice is putting together to brief interested parties in the Washington area on the study. The event will be held when the investigators are in the Washington area for the annual meeting. The Technical Committee will confirm the investigators' availability and provide suggestions on attendees. At Jerry Rice's request, the Technical Committee scheduled a conference call to talk with him about the symposIUm. Patsy and Jennifer reported on discussions they had with Richard Irons on several subjects. They concluded that some investigators, particularly those at Fudan who are less familiar with industry-sponsored science, were uncertain about the companies' role. As a result, they sent a note clarifying that the SHS is an independent study under the direction of the Principal Investigators. The Technical Committee agreed to evaluate their procedures for communications with investigators, clarify them where appropriate, and discuss them with the investigators. SHELL-MCCLURG-052911 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Thursday, June 16,20059:01 PM (GMT) benzconsort-tc@listserve.api.org Jmricewas@aol.com BHRC-TC... RE: Georgetown Symposium / Invitation questions BZattendees8.3.04.xls -----Original Message----From: Jmricewas@aol.com [mailto:Jmricewas@aol.com] Sent: Thursday, June 16, 2005 4:49 PM To: Bruce Jarnot Subject: Re: FYI, re: BHRC... Georgetown Symposium / Invitation questions Dear Bruce, As first steps towards identifying individuals in the DC area who might usefully be invited to the Nov 4, 2005, meeting at Georgetown: (1) I attach an Excel file listing 40-plus attendees at the Munich Benzene Symposium in October 2004, with their e-mail addresses and affiliations, including several epidemiologists from the NCI with an active research interest in benzene; (2) Two organizations in the Washington area, other than government, where there is likely to be interest are the Society of Toxicology (www.toxicology.org) and the Risk Science Institute of ILSI. Specifically, I would propose Dr Steve Olin of ILSI (solin@ilsi.org) as a potential attendee. As more potential attendees come to mind I will add them to the list for consideration. Jerry SHELL-MCCLURG-052912 A ."1 " Chair 2 3 III Pt 3 4 n/a 5 n/a 6 n/a 7 n/a 8 n/a 9 n/a 101l1Pt1&2 11 Panel 12 n/a 13 n/a 14 VI Pt 3 15 n/a 16 n/a B Speaker nfa nfa nfa VI Pt 3 III Pt1 VI Pt 3 VI Pt 1 I nfa nfa Panel nfa VI Pt2 III Pt 3 17 n/a 18 n/a 19 VIII 20 n/a 21 n/a 22 V 23 n/a 24 n/a 25 n/a 26 n/a 27 VI Pt 1,2 28 n/a 29 n/a 30 IV 31 n/a 32 n/a 33 n/a 34 n/a 35 n/a 36 VII 37 n/a 38 n/a 39 n/a 40 n/a 41 n/a 42 n/a 43 IV 44 45 VI Pt1 II nfa V III Pt2 Panel nfa VIII nfa III Pt 1 III Pt 1 nfa VI Pt1 III Pt 1 II III Pt 3 nfa Panel Panel VI Pt2 VI Pt2 I III Pt 3 III Pt2 c Last Name Beatty Bird Bond Eastmond Farmer Felix French Glass Goldstein Greim Gundert-Remy Hayes Henderson Hirabayashi Irons Jaiswal Kang Kipen Kuang Lan Larson Levy Li Liang Morgan Oesch Qu Rappaport Rice Ross Rothman Ruchirawat Schnatter Smith Snyder Sonawane Trush Vaughan Winn Wong Yin Zhang D First Name Patrick Michael James David Peter B. Carolyn Jef Deborah C. Bernard Helmut Ursula Richard B. Rogene Yoko Richard D. Anil Seong-Kyu Howard Shouren Qing Richard Leonard Guilan Youxin Gareth Franz Qingshan Stephen Jerry David Nathaniel Mathuros Robert A. Martyn Robert Robert Michael Andrew Louise Otto Songnian Luoping E Response Yes Yes Yes Yes Yes ? Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Email F patrickbeatty@chevrontexaco.com michael.g.bird@exxonmobil.com toxcon@earthlink.net david.eastmond@ucr.edu pbf1@1e.ac.uk felix@email.chop.edu french@niehs.nih.gov deborah.glass@med.monash.edu.au bdgold@pitt.edu helmut.greim@lrz.tu-muenchen.de u.gundert-remy@bfr.bund.de hayesr@mail.nih.gov rhenders@lrri.org yokohira@nihs.go.jp richard.irons@uchsc.edu ajaiswal@bcm.tmc.edu skk@kosha.net kipen@eohsi.rutgers.edu kuang_sr@21cn.com qingl@mail.nih.gov rlarson@medicine.bsd.uchicago.edu IsI1@1e.ac.uk guilanli@263.net.cn yxliang@shmu.edu.cn Gareth.Morgan@rmh.nthames.nhs.uk oesch@mail.uni-mainz.de qingshan@env.med.nyu.edu smr@unc.edu jmricewas@aol.com david.ross@uchsc.edu rothmann@epndce.nci.nih.gov mathuros@tubtim.cri.or.th a.r.schnatter@exxonmobil.com martynts@berkeley.edu rsnyder@eohsi.rutgers.edu sonawane.bob@epamail.epa.gov mtrush@jhsph.edu avaugha@lumc.edu winnl@biology.queensu.ca ottowong@aol.com guilanli@263.net.cn luoping@berkeley.edu G Talk NfA NfA NfA Mechanistic Studies on the Inhibition of Topoisomerase II by Bioactivated Hydroquinone The Use of Urinary S-phenylmercapturic Acid as a Biomarker in Molecular Epidemiology Studies of Benzene The Health Watch Case Control Study: Exposure and Risk NfA NfA NfA Benzene and Cancer in China NfA p53 Dependent Gene Profiling for Reactive Oxygen Species After Benzene Exposure The Shanghai Health Study: Preliminary findings on Benzene Poisoning in Shanghai, China QUinone OXldoreductases In Protection Against Myelogenous Hyperplasia and Benzene Toxicity Occupational Exposure to Benzene in South Korea NfA Diagnosis and Treatment of Chronic Benzene Poisoning Benzene Exposure and Hematotoxicity NfA OvelView of Benzene Exposures and Regulartory Levels in Western Countries NfA An OvelView of Benzene Exposure by Industry and its Historical Trends of Exposure Levels in China The Impact of Xenobiotic Exposure on the Haemapoetic Stem Cell NfA Biomarkers of Benzene: Urinary Metabolites in Relation to Individual Genotype and Personal Exposure Protein Adducts as Biomarkers of Human Benzene Metabolism NfA NQ01: Metabolic Multitasking and Clues to Benzene Toxicity Environmental and Occupational Exposure to Benzene in Thailand OvelView of Epidemiologic Studies on Benzene and Leukemia Use of 'Omics' Technologies to Study Humans Exposed to Benzene NfA NfA NfA Apoptotic Effectors and Genomic Instability The Role of c-Myb in Benzene-Initiated Toxicity Benzene Exposure and non-Hodgkin's Lymphoma Advances in Cohort Study on Benzene and Leukemia in China Molecular Cytogenetics of Benzene-Exposed Workers Organization H ChevronTexaco ExxonMobil Chemico-Biologicallnteractions UC Riverside University of Leicester University of Pennsylvania NIEHS Monash University, Australia University of Pittsburgh Technical University of Munich Federal Institute of Risk Assessment, Berlin National Cancer Institute Lovelace Institute National Institute of Health Sciences, Tokyo, Japan University of Colorado Baylor College of Medicine Korean OSHA University of Medicine and Dentistry of New Jersey Guangdong Occupational Disease Prevention Center NCI Section of Hematology/Oncology, University of Chicago University of Leicester China CDC China CDC Institute of Cancer Research, Sutton, UK University of Mainz New York University University of North Carolina Georgetown University University of Colorado National Cancer Institute Mahidol Univerisity ExxonMobil Biomedical Sciences, Inc. UC Berkeley Rutgers, The State University of New Jersey Environmental Protection Agency Johns Hopkins University UC Davis Queens University Applied Health Sciences Chinese Academy of Preventitive Medicine UC Berkeley Continent N. America N. America N. America N. America Europe N. America Fed Australia N. America Europe Europe Fed N. America Asia N. America N. America Asia N. America Asia Fed N. America Europe Asia Asia Europe Europe N. America N. America N. America N. America Fed Asia N. America N. America N. America Fed N. America N. America N. America N. America Asia N. America J Travel V1 $1,000 $1,000 $1,000 $1,000 $500 $1,000 $0 $1,500 $1,000 $500 $500 $0 $0 $1,500 $1,000 $1,000 $1,500 $1,000 $1,500 $1,000 $1,000 $500 $1,500 $1,500 $500 $500 $1,000 $1,000 $1,000 $1,000 $1,000 $1,500 $1,000 $1,000 $1,000 $0 $1,000 $1,000 $1,000 $1,000 $1,500 $1,000 $39,000 &[DATE] SHELL-MCCLURG-052913 ."1" Address Line 1 K 2 ChevronTexaco Energy Technology Company, P. O. Box 1627,100 Chevron Way, Richmond, CA 94802 3 ExxonMobil Biomedical Sciences 4 ToxCon 5 Environmental Toxicology Graduate Program 6 Cancer Biomarkers and Prevention Group, Biocentre 7 Abramson Research Center, Room 9028 8 Laboratory of Molecular Toxicology 9 Department of Epidemiology and Preventive Medicine, Centre 10 University of Pittsburgh 11 Technical University of Munich 12 Federal Institute for Risk Assessment 13 EPS8114 14 Lovelace Respiratory Research Institute 15 Cellular and Molecular Toxicology Division, Biolo 16 University of Colorado 17 Department of Pharmacology 18 Korea Occupational Safety and Health Agency 19 Environmental & Occupational Health Sciences Institute 20 Guangdong Poison Control Center 21 Occupational Environmental Epidemiology Branch 22 5841 South Maryland Ave.ve 23 MRC Institute for Environment & Health 24 National Occupational Health and Poison Control 25 School of Public Health 26 Department of Haemato-Oncology 27 Institute ofToxicology 28 Nelson Institute of Environmental Medicine 29 School of Public Health 30 Georgetown University 31 Department of Pharmaceutical Sciences 32 Occupational Studies Section 33 Chulabhorn Research Institute 34 Room LF-246, 35 School of Public Health 36 Rutgers, The State University of New Jersey 37 8623D, USEPA Headquarters 38 Johns Hopkins Bloomberg School of Public Health 39 12260 SW Duchilly Ct. 40 Department of Pharmacology and Toxicology 41 Applied Health Sciences, Inc. 42 National Occupational Health and Poison Control 43 School of Public Health 44 45 Address Line 2 L P. O. Box 1627 1545 Route 22 East 5505 Frenchmans Creek 5429 Boyce Hall University of Leicester 3615 Civic Center Blvd NIEHS, NIH Central and Eastern Clinical School Graduate School of Public Health Hohenbachernstrasse 15-17 Press and Public Relations Office National Cancer Institute 2425 Ridgecrest Dr SE Biological Safety Research Center Health Science Center Baylor College of Medicine 34-6 Gusan-dong - Inchon 403-711 UMDNJ-Robert Wood Johnson Medical School 165# Xin-gang Road Division of Cancer Epidemiology & Genetics MC 6092 University of Leicester China CDC Fudan University Royal Marsden Hospital University of Mainz New York University School of Medicine CB#7431 Lombardi Cancer Center School of Pharmacy, C238 National Cancer Institute c/o Faculty of Science ExxonMobil Biomedical Sciences, Inc. UC Berkeley 160 Frelinghuysen Rd Ariel Rios Building 615 North Wolfe St., Rm 7033 Tigard, OR 97224 Queen's University 181 Second Avenue, Suite 628 China CDC UC Berkeley M Address Line 3 100 Chevron Way PO Box 971 Durham, NC 27713 Riverside, CA 92521 University Road Philadelphia, PA 19104-4318 111 T.W. Alexander Drive The Alfred Hospital A624 Crabtree Hall D-85354 Freising Thielallee 88-92 Bethesda MD 20892 Albuquerque, NM 87108 National Institute of Health Sciences Denver, CO 80262 One Baylor Plaza REP. OF KOREA 170 Frelinghuysen Rd. Haizhu District, Guangzhou 510300, P. R. CHINA National Cancer Institute AMB W604 94 Regent Road 29 Nan Wei Rd 138 Yi Xue Yuan Rd Downs Road, Sutton Obere Zahlbacher Str. 67 57 Old Forge Road University of North Carolina 3213 Coquelin Terrace University of Colorado Health Sciences Center 6130 Executive Blvd Mahidol University PO Box 0971 140 Warren Hall #7360 Piscataway, NJ 08854-8020 1200 Pennsylvania Avenue, N. W Baltimore, MD 21205 N Address Line 4 Richmond, CA 94802 Annandale, NJ 08801-0971 Address Line 5 o Leicester LE1 7RH, United Kingdom Rail Building, Rm F167 Commercial Road 130 DeSoto Street Weihenstephan 14195 Berlin GERMANY Research Triangle Park, NC 27709-2233 Melbourne, Vic 3004, Australia Pittsburgh, Pennsylvania 15261 Germany 1-18-1, Kamiyoga Setagayaku, Tokyo-158-8501, Japan Houston, TX 77030 Piscataway, NJ , 08854 6120 Executive Blvd., EPS Room 8109 Chicago, IL 60637 Leicester LE1 7DD United Kingdom 100050, Beijing, PR China 200032 Shanghai, P.R. China Surrey SM2 5PT, United Kingdom D-55131, Mainz, Germany Tuxedo, NY10987 Chapel Hill, NC 27599-7431 Chevy Chase, MD 20815 Denver, CO 80262, USA. Executive Plaza North, Room 418 Rama 6 Road 1545 Route 22 East Annandale Berkeley, CA 94720 Bethesda, Maryland 20892-7238 Rockville, MD 20892 Bangkok 10400, Thailand NJ 08801-0971 Washington, DC 20460 Kingston, Ontario, K7L 3N6, Canada PO Box 2078 29 Nan Wei Rd 140 Warren Hall #7360 San Mateo, CA 94401 100050, Beijing, PR China Berkeley, CA 94720 &[DATE] SHELL-MCCLURG-052914 c E GH Chinese Academy of Preventitive Medicine, Beijing, China SHELL-MCCLURG-052915 1;1 SHELL-MCCLURG-052916 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Thursday, November 18, 2004 9:01 PM (GMT) benzconsort-tc@listserve.api.org Howard Feldman <Feldman@api.org>; Mark Fitzsimmons (E-mail) <mfitzsim@steptoe.com> BHRC-TC... Draft Conf Call Minutes Draft Minutes BHRC-TC Conf Call 11 18 2004. doc BHRC Technical Committee & colleagues - Attached are draft minutes for your review and feedback; due to the quick response needed for open action items, this DRAFT file is being circulated for parallel reviews vs. serial Legal and Chair preview ... Thanks in advance! Bruce. SHELL-MCCLURG-052917 Benzene Health Research Consortium Technical Committee Draft Minutes Conference Call - 18 Nov 2004 Participants Patrick Beatty (ChevronTexaco) Steve Bose (ExxonMobil) Don Burnett (BP) Stuart Cagen (Shell) Jennifer Galvin (ConocoPhillips) Howard Feldman (API; part-time) Bruce Jarnot (API) Administrative Items Call was conducted in accordance with API antitrust guidelines Agenda: discuss I review "action items" generated at early-November OC meeting in Houston o Expectation to provide update(s) by 10 December 2004 Background Most Action Items can likely be met by PI discussion(s) $3.3MM gap identified by Pis has led to sense of urgency o OC deferred most action items to the TC o Funding required to carry the studies to completion o Approx 2x of Rich Irons Oct 2004 estimate o Possible BP $1.7MM added contribution? o May not include Richard's T&E increase, post-2007 General Discussion Items Acticil"l- Prioritization under current funding? (Alternate approach, still pending ... ) o Prioritization by SRP/ERP o Prioritization by Pis? o Consequences & implications noted if studies re-scoped by prioritization Draft Minutes for Review Page 1 of 3 SHELL-MCCLURG-052918 Benzene Health Research Consortium Technical Committee Meeting Notes o OC has ID'ed -$600K possible cost savings ("sweat equity" approach) Added cost of exposure assessment o How much of Yimei's costs embedded in Richard's re-analysis? 2-month (longer?) replacement for Patrick not ID'ed (ChevronTexaco) o Patrick will be on short term disability starting end-of-December ~IW8.ii8.iat Discuss "Action Items" in-person with Richard o Benefit seen of having Denver meeting with Richard & -TC o Invite Otto to attend/participate? Action:o Patrick/Stuart to call or email regarding possible meeting Long-standing Action Items ActiOn: Review Munich attendee list for possible scientific involvement follow-up o Defer to 2005, pending resolution of scope scale-back & budget reanalysis o Might this miss a window of opportunity (risk of becoming a "stale issue"?) ActiOn: Do we need a formal QAlQC audit of Shanghai? o liBBBlllil affirm recommendation that this -$1 OOK line-item be dropped o QAlQC will be internally covered by JCML lab accreditation o 18~pi6p8;it TC delegation to visit & "spot check" lab operations Goes toward demonstrating sponsor due diligence New Action Items Nat Rothman (NCI Investigator) proposed NCI/Consortium collaboration o NCI China CC Study proposed, beginning 2007 o Action: TC to discuss NCI's offer with PI's o Ir8iffips.llil include in PI discussions A\ct!oo: options for JCML continuation, via outside funding? o Contingent upon Fudan plans ... Draft Minutes for Review Page 20f3 SHELL-MCCLURG-052919 Benzene Health Research Consortium Technical Committee Meeting Notes o Continue within School of Public Health (i.e., likely to be shut down) o Or establish JCML as separate, free-standing department o Fudan decision possible by end-of-year o lildWb.issl Ask Richard if he sees value in having Company rep's meeting with Fudan (risk of sponsors "taking sides" with internal Fudan politics?) o Wf6iffiBI;t include in PI discussions Action: confirm Budget Re-analyses as being complete & comprehensive o Anything overlooked (e.g., Richard T&E cost increase) o Any "cost overlap" (e.g., Yimei's time-in-field in Richard's re-analysis vs. EMBSI funding her effort) o WiaffiBI;t include in PI discussions Action: reality check of exposure assessment o Do we need more than a yes/no for CC exposures? o Is there an association between Bz and NHL? AML? o CC dose-response may be "nice to have", but not critical to study o 1f.8.iffiB.i"m:l: check w/ SRP & Pis ... can we cut back on level of assessment? - don't need to hit a home run each time to win the game o Ir8iffips.llil include in PI discussion 1. Pis to reconsider "what can really be done" in exposure assessment?" 2. Will this provide some of the answers (may be an ethics consideration) Draft Minutes for Review Page 30f3 SH ELL-MCCLU RG-052920 From: Sent: To: Subject: Attach: Matt Todd <ToddM@api.org> Friday, October 29, 20042:36 PM (GMT) BHRC Oversight Committee (E-mail) <benzconsort-oc@listserve.api.org>; BHRC Technical Committee (E-mail) <benzconsort-tc@listserve.api.org>; BHRC Communications Committee (E-mail) <benzconsort-cc@listserve.api.org> FW: Economist article on China's health care system China's Healthcare - Where are the Patients.doc BHRC Committee Members: The attached document is an article about the Chinese healthcare system that Lynn Russo has requested I forward on to you. Her note is below. Best regards, Matt Matt, this article may be of interest the rest of the consortium. It appeared in the Economist in late August (this magazine circulates here in the office and I'm at the end of the chain of folks who read it). It's a special report on China's healthcare and is very interesting. There is a lot about the very poor health care situation in the countryside, which doesn't apply to Shanghai. (In fact, they say health indicators around Shanghai are as good as in many western countries.) But they explain the government as a big incentive for reforming the system--apparently concerns about health care costs are leading to lower peronal savings, meaning less investment/growth. And they mention some of the options that could be considered, indicating it's all up in the air today. The article describes the very difficult situation the PI's are working in and suggests some of the reasons decisions on the lab have been slow. (See attached file: China's Healthcare - Where are the Patients.doc) Lynn SHELL-MCCLURG-052921 From: Sent: To: Cc: Subject: Attach: Lorraine Twerdok <Twerdokl@api.org> Monday, August 26,20023:27 PM (GMT) Benzene OC listserve (E-mail) <BenzConsort-OC@api.org> Benzene consort comm (E-mail) <benzconsort-cc@api.org>; Benzene consort tech (Email) <benzconsort-tc@api.org>; 'myron. c. harrison@exxonmobil. com' (E-mail) <myron.c.harrison@exxonmobil.com>; Mark Fitzsimmons (E-mail) <mfitzsim@steptoe.com> BHRC - Oversight Committee Call Summary 8123/02 08-23-2002 OC minutes. doc 08-23-2002 OC minutes.doc To BHRC Oversight and Recruitment Committees: Please find attached, for your review and comment draft minutes from the 8/23/02 conference call. As you recall, we scheduled a meeting to address recruitment issues for: Date: Friday, September 13 Time: 8:30 AM - 3:30 PM Location: Houston (location/hotel details to follow) All members of all committees are invited to attend this meeting to develop consortium recruitment procedures for funding, regulatory and NGO participation. Paula Podhasky will be handling the meeting logistics. Thanks, Lorraine SH ELL-MCCLU RG-OS2922 DRAFT August 25, 2002 BHRC Joint Oversight CommitteefRecruitment WG Call Summary August 23, 2002 Participants: Patrick Beatty, ChevronTexaco Michael Bird, ExxonMobil (part-time) Don Burnett, BP Stuart Cagen, Shell Patsy Clegg, Shell Myron Harrison, ExxonMobil Lynn Russo, ExxonMobil Paula Podhasky, API Matt Todd, API Lorraine Twerdok, API George Woodall, API Mark Fitzsimmons, Council Minutes from 8/5/02 Oversight Committee call approved; will be posted to committee website (Paula). Purpose of call was to develop a clearer path forward for consortium recruitment efforts and to determine basis for 2003 invoicing of consortium sponsors. Recruitment includes of all types of stakeholders, funding sponsors, regulators, health organizations, labor, NGOs, etc. Recruitment: It was decided that recruitment require a face-to-face meeting to get procedures "written down on paper." Patsy Clegg and Patrick Beatty volunteered to organize this meeting, which will take place as follows: Date: Friday, September 13, 2002 Time: 8:30 AM - 3:30 PM (tentative) Location: Shell Woodlands training facility, Houston (travel details to follow) Overall, it was decided that it is time to involve high-level company people in the recruitment efforts, and the Houston meeting will provide a strategy to accomplish this. One candidate company to approach at this senior level is Petronas. The following recruitment-related action items are to be accomplished in preparation for the meeting: 1. Formal recommendation to BHRC on regulator/NGO participation - Patrick, due 8/30/02. 2. Draft committee roles and responsibilities - Patrick and Lorraine, due 8/30/02. { FILENAME \ * Lower\p \ * MERGEFORMAT } SH ELL-MCCLU RG-052923 DRAFT August 25, 2002 3. A first contact with Petrochina (Houston) to set up a briefing will be made by 9/13/02 - Myron and Stuart. 4. A first contact with Sinopec (New York) to set up a briefing will be made by 9/13/02 - Lorraine, Patrick, Bill Frick. 5. Identify/contact key individuals within sponsor companies (API Board level) for aid in recruitment, particularly for funding sponsors - all OC members. 6. Draft recruitment/presentation package to be circulated to Oversight and Technical committees for review by 9/6/02 - Communications Committee. 7. Follow-up contact with Dow to be made by Michael Bird (technical- David Hunt) and Lynn (chemical company contact) by 9/13/02. 8. List of organizations for recruitment contact (all types, funding, regulators, NGOs) due to Lorraine 9/4/02 - ALL. Specific, i.e. individual names, contact information would be helpful. Lorraine will integrate list and circulate for use at 9/13/02 meeting. 9. Follow-up contact with Marathon Ashland will be made by 9/13/02 - Patrick. 10. Technical contact with Lyondell (Stacey Banton) will be made by 9/13/02 - Stuart. 11.9/13/02 meeting logistic information to be distributed ASAP - Paula and Patsy. 12. Request list of potential funding opportunities from Rich Irons for 9/13/02 meeting - George. 13. Minutes of this call due out by noon, 9/26/02 - Lorraine Invoicing: 2002 - invoice will be 25% of the original $19.7 M estimate. 2003 - BP (3 shares), ChevronTexaco (2 shares) and Shell (2 shares) voted to invoice companies for the remaining not-to-exceed commitment for all companies. This amount will be slightly less than the 2002 invoice due out in two weeks. ACTIONS: 1. 2002 invoice to go out by 9/6/02 - Paula 2. Inform Conoco of 2003 invoicing decision - Lorraine. 3. Develop spreadsheet for 2003 invoicing amounts and circulate to OC Paula. { FILENAME \ * Lower\p \ * MERGEFORMAT } SH ELL-MCCLU RG-OS2924 From: Sent: To: Cc: Subject: Attach: George Woodall <Woodallg@api.org> Tuesday, August 6,20025:53 PM (GMT) BenzConsort-TC@api.org Lorraine Twerdok <Twerdokl@api.org>; Paula Podhasky <Podhaskyp@api.org>; Matt Todd <ToddM@api.org> Meeting Minutes - Technical Committee (July30, 2002) Minutes-BHRC-TC-30July2002.doc Technical Committee; Attached are the draft meeting minutes of our meeting last week at API HQ in Washington, DC. This set of minutes have been reviewed and approved by legal counsel. As mentioned in the meeting, there will be a two-week review period after which the minutes will be made final. Please send comments and corrections to my attention or to the listserver (BenzConsort-TC@listserve.api.org) before August 21, 2002. Thank you, George M. Woodall, Ph.D. Senior Toxicologist American Petroleum Institute 1220 L Street, NW Washington, DC 20005 Tel. (202) 682-8067 Fax. (202) 682-8031 SH ELL-MCCLU RG-052925 DRAFT - August 5, 2002 Meeting Minutes Technical Committee - Benzene Health Research Consortium API Headquarters - Washington, DC July 30, 2002 Participants: Patrick Beatty (Chair), ChevronTexaco Stuart Cagen (Vice Chair), Shell Shan Tsai, Shell Bill Broddle, Conoco Michael Bird (by Phone), ExxonMobil Don Burnett (by Phone), BP Issues: Committee Business Draft meeting minutes and conference call summaries o It was proposed and accepted by the committee that draft minutes will be sent out for review, and if no changes or corrections are sent that they will become final after a two-week period. o Previously drafted minutes will become final following review by legal counsel. Governmental Organization Status Recommendation - requested by the Oversight Committee. Proposal for a "Competent Authorities Body" to include the governmental organizations and NGOs, with a dotted line relationship to the Technical Committee was discussed but not endorsed. Technical Committee's recommendation: o Expand the Technical Committee to include members with observer status. o Develop a list of regulatorylgovernmental bodies from throughout the world to invite to join (EPA, OSHA, Cal-EPA, NIOSH, WHO, Health Canada, NIH, EU, CDCIATSDR, IARC, etc.) o Convene a meeting of the invitees to describe the study in detail and to define their role within the Technical Committee. o As a follow-up to that meeting, provide a list of activities that these organizations may be able to contribute to on an equity basis (types of analyses that might be performed - either in the current protocols or in addition to those in the protocols). Proposed role: Would participate in the Annual Meeting as a part of the Technical Committee. Would participate in all Technical Committee meetings but not in discussion on financials - financial aspects would be covered during one-half of a fullday meeting with only the sponsor members, followed by the rest of the meeting open to the full membership. Action Items o TC Members: Provide a list of regulatoryladvisory governmental organizations (worldwide) to invite. [See request for similar information from the Communications Committee, sent out July 31,2002.] 1 SH ELL-MCCLU RG-052926 DRAFT - August 5, 2002 ProgresslFinancial Reporting - the following is a summary of the main issues identified from the June 2002 progress and financial reports. 1. Calendars - API operates on a fiscal year that begins on January 1. UCRSC operates on a calendar that begins on July 1. In his progress report, Dr. Irons refers to a fiscal year that ends on August 31. Dr. Irons reports finances in his progress report up to May 30, which does not match the financial reporting period coming from the University that ends on June 30. The proposal accepted by the TC was to establish one set of dates for both progress reports and financial reports (semi-annual), with periods ending June 30 and December 31. Every other fiscal year and reporting date should be adjusted to coincide with those dates. The invoices to the consortium sponsors are scheduled to go out in August, and that should not be affected by this proposal. 2. Reporting Frequency - Otto Wong has suggested that all reports be on a semiannual basis. Currently he has a requirement to report quarterly in his contract, and Dr. Irons is required to report semi-annually. The proposal to have all contract/grant reporting frequencies to be semi-annual, based on the dates proposed under item 1 above was accepted. 3. Travel Expenses - The UCRSC financial reports are showing travel-related charges and projections for continued charges. It was understood that all the travel expenses for the DP and ME Studies would be under Dr. Irons' separate contract. Enquiries will be made to see what are these charges and if they are appropriate. 4. UCSRC Financial Report Form - The format was changed by UCSRC from the original format agreed to for this reporting. A revised format has been proposed that can be used from this point forward (see attached) that will track both actual and budgeted values for the following: total previous expenditures, current expenditures, expenditures to date, and project totals. Some other discrepancies in the report will also be investigated in consult with UCRSC. 5. UCRSC Contract Addendum - In his June, 2002 Progress Report, Dr. Irons lists an issue with the current grant not including the revised project budget. The TC agrees that this should be remedied and proposes that a letter from the OC indicating the decision to increase the budget be sent to UCRSC, and that an amendment to the Grant Agreement be instituted to reflect those changes in budget. 6. Fudan Contact Issue - The first contract with Fudan University (covering the last 5 months of 200 1) was signed late but without significant revisions. The second contract (covering 2002) has been delayed significantly due to numerous revision requests by Fudan and negotiations with API. Additional delays were due to a revised budget for the contract (see next point) and an expectation by the officials at Fudan that the revised budget would be accepted as submitted. The signed contract has been signed so this issue has been resolved. 7. Fudan Case-Control Study Budget Issue - The original estimated budget total for Fudan University was $191K; the revised budget total submitted by Fudan in June was $661K. The increase in budget was reflective (at least in part) of the 2 SH ELL-MCCLU RG-OS2927 DRAFT - August 5, 2002 increased exposure assessment activities required after the SRP review. My understanding, based on the January 2001 presentation given by Dr. Irons, was that the additional costs for staff involvement and other costs associated with the increases in the exposure assessment would be born by the UCRSC grant and was reflected in the increased budget (see attached spreadsheet IronsPost-SRPBudget.XLS). In subsequent communications between Dr. Irons and Dr. Fu, it seems that there is some split among the costs being covered by UCRSC and the separate contract between Fudan University and API (see attached e-mail from Dr. Fu that includes an e-mail from Dr. Irons to Dr. Fu). At present, there is no clear indication what that split should be, and this is hampering the ability of API to modify the contract values for Fudan. A communication has been sent to Dr. Irons requesting clarification of the details for what is covered in the contract between Fudan and UCRSC, so that API will better be able to determine the outstanding need for resources on the contract with Fudan. 8. Ongoing IRB Fees - COMIRB has changed their policy and instead of charging a fee only when they review a protocol, they are also asking for funds on an annual basis (see attached e-mail "COMIRB Fees"). In addition to that information, G. Woodall was informed in a conversation with Wayne Stillman that this project has three protocols that were submitted for review (not two). The third protocol is for the Metabolism Feasibility Study (attached in e-mail titled "Documents"). Action Items o G. Woodall: Investigate the nature of the travel budget in the grant. Understanding was that all travel would be through the separate contract with Dr. Irons. o G. Woodall: Send revised financial report format and other questions regarding the financial report to UCRSC for clarification. [Completed. See attached emai1.] o Oversight/Technical Committee: Send a letter to UCRSC indicating that the approved budget has been increased as of January 2002, and that a revised grant agreement is forthcoming. o G. Woodall/L. Twerdok: Revise the grant agreement as indicated in the point above. o G. Woodall: Set-up a conference call with both Dr. Wong and Dr. Irons on-line to discuss the split in contract coverage for the Fudan University portion of the expanded exposure assessment. Both the OC and TC will be invited to have a representative join the cal1. o G. Woodall: Contact Dr. Irons and get clarification about the nature of the 3rd protocol (Metabolism Feasibility Study) and the review process that was undertaken on that protoco1. Milestones - Many of these for the DP and ME Studies have been taken from the list suggested by Dr. Irons in his progress report. Publication milestones should be added to all studies. Case-Control Study 3 SH ELL-MCCLU RG-052928 DRAFT - August 5, 2002 o Milestones will be based on case accrual by disease (NHL/AML - 500 total cases or 125/year for 4 years) Disease Progression Study o Missing from the list are decision points along the way that would help determine if continuation along a line of research is warranted: Determination of unique identifiers/markers for benzene-induced leukemia. Assessments of whether certain assays/analyses are useful/feasible. o Case accrual - need to break out by number of cases for each diseases and not as an aggregate alone (based on expected incidence) The protocol mentions annual disease rates as follows: 50 cases AAlyr; 60 cases MDS/yr; 120 cases AML/yr. Major Issue: Determine the number of cases needed to acquire adequate statistical power and the length of time that will be needed to accrue that number of cases (potential that it may take longer than the five year project length). o Include reporting obligations in milestones o Include expected/actual/deviation in the number of cases in the progress reports. o Dr. Irons list has exposure assessment done prior to identifying cases - check on that detail. Molecular Epidemiology Study o Need clarification on timing of the phases Is the plan to identify all 200 highly exposed individuals first then look at feasibility of doing later phases, or Do the factory-by-factory approach as shown in the draft milestones. If the latter, what are the costs for each factory and when do you reach a decision point on when the study will yield results. Action Items o G. Woodall: Contact Dr. Irons to get clarification on his list of milestones on a number of issues related to case accrual rates, timing for phases within each of the studies, overall length of study, etc. o G. Woodall: Set-up a conference call between the TC, and Drs. Irons and/or Schnatter to discuss the timing of phases within the ME study. o Drs. Irons and Wong: Add publication milestones on all studies. Prioritization - requested by the Oversight Committee to determine the options if additional sources of funds are not found. Regrets Analysis - based on the presentation in January 2001 by Dr. Irons. o Incremental cuts suggested by Dr. Irons would get $1. 6M in cuts if all were adopted - would be accompanied by major regrets. o However, this was based on the budget at that time of$16.5M and does not include the budget increases due to the Scientific Review Panel (SRP) recommendations. o Any changes would require approval by the SRP and the IRBs, which could call for a close to the project due to decreased scientific benefit from the pared-down study. 4 SH ELL-MCCLU RG-052929 DRAFT - August 5, 2002 Only way to get to $3-4M in savings would be to cut out one of the studies (CaseControl; Disease Progression; or Molecular Epidemiology) which would effectively stop the project. o Cutting anyone of the studies would entail major regrets including the withdrawal of support for the project from the Chinese, thus ending the project. Recommendation from the Technical Committee (in order of preference): o Get additional sponsors using a new marketing focus that emphasizes: New studies such as HealthWatch raise additional questions that the Shanghai Study may help to answer. That this is a unique opportunity to couple high exposure levels with modern analytical techniques when compared to previous studies. Need to identify more potential sponsors with more active follow-up (e.g., Dow) Need to act ASAP on additional funding efforts. o Investigate potential for an API Safety Net. API would only cover costs not covered by additional funding. Need to find a "champion" among one of the sponsor company CEOs to plead the case to the other CEOs within API o Investigate potential for other "partners" to help fund pieces of the project (e.g., EPA pay for one type of analysis to be performed in the ME Study). May also include applying for grants. o Pursue additional funding from the existing sponsors All other potential funding avenues should be pursued first (those listed above as well as the options for cutting back) in order for this proposal to even be considered. September 11th effect o Delays have resulted in increased costs o More difficult to get visas for Chinese nationals to come to US for training. o More difficult to get equipment into China. Funds from the Petroleum Product Stewardship Council o $300K in unspent funds o Can this be used in BHRC? Who at API can answer that question? Timelines o Annual API Meeting in October - need to identify any potential CEO champions and brief them prior to that meeting o Follow-up with Dow in the next two weeks. Action Items o Marketing Group: Needs to become more aggressive in attaining new sponsors. Need to revitalize marketing materials and change the marketing focus (adding governmental bodies as part of and expanded TC may be a positive aspect; answering the questions raised by HealthWatch may also be a useful inducement). o TC Members: Identify a CEO Champion within the API member companies to encourage the "API Safety Net" as a consideration to secure the project if the marketing approach fails. Annual Meeting scheduled to occur October 14-15, 2002. 5 SH ELL-MCCLU RG-OS2930 DRAFT - August 5, 2002 o M. BirdlL. Twerdok: Follow-up with Dow to determine interest level and chance to add them as a sponsor. o G. Woodall: Get input from Dr. Irons on a revised "Regrets Analysis" based on the new budget and protocols; similar to his analysis presented at the January 2001 meeting. 2002 Invoice Recommendation - Request for a recommendation on whether the August 2002 invoice should be based on 25% of$16.5M or $22.8M Recommendation to send an invoice for the previously expected amount and then send an invoice in January for any adjusted funding needs. Action Item o G. WoodalllP. Podhasky: Need to get total invoice requests for 2003 to the sponsor companies ASAP so they can plan appropriately. This should include any amounts that may be included in a January 2003 Invoice. 6 SH ELL-MCCLU RG-OS2931 From: Sent: To: Subject: Attach: Paula Podhasky <Podhaskyp@api.org> Monday, August 5,20025:33 PM (GMT) BenzConsort-TC@api.org; Benzconsort-cc@api.org FW: Shanghai Health Research Oversight cmte Call 5 aug 2002 agenda OC Call.doc; ASILOMAR DRAFT AGENDA doc; 2002 Invoice options.xls fyi -----Original Message----- From: Paula Podhasky Sent: Monday, August 05, 2002 9:33 AM To: 'BenzConsort-OC@listserve.api.org' Subject: Shanghai Health Research Oversight cmte Call Importance: High REMINDER - Oversight Committee Call scheduled as follows: Date: Monday, August 5,2002 Time: 2PM, EDT Dial-in number: 1-866-262-1780 (domestic) 1-205-354-0100 (international) Meeting #: * 0495614 * (stars required) 5 aug 2002 agenda OC Call.doc ASILOMAR DRAFT AGENDA.doc options.xls 2002 Invoice SH ELL-MCCLU RG-OS2932 AUGUST 2002 INVOICE OPTIONS AB 1 Benzene invoicin{J 2 3 Company Name 4 5 BP 6 7 Chevron 8 9 Conoco 10 11 ExxonMobil 12 13 Shell 14 15 16 Column Total 17 18 Cumulative Total 19 20 21 22 2001 Pro{Jram Cost 23 24 25 15% of total cost 26 27 28 29 30 31 32 Formula 33 (program costlll) (#sharel company) (%) 34 35 36 1 Year 1 invoices billed as percent of 2001 estimated total proqram cost C D EF Commitment NOT TO EXCEED 4,224,000 3,000,000 1,408,000 5,000,000 3,000,000 16,632,000 Shar e 3 2 1 3 2 11 G August-01 I YEAR 1 15% 806,441 537,627 268,814 806,441 537,627 HI January-02 15% 806,441 537,627 268,814 806,441 537,627 2,956,950 2,956,950 2,956,950 5,913,900 19,713,000 1 2,956,950 2002 Pro{Jram Cost 25% of total cost 2002 Pro{Jram Cost 25% of total cost Example: Example: ($22,789,299/11) (1 share) (.25) = ($16,632,000/11) (1 share) (.25) = July 3,2002 SH ELL-MCCLU RG-OS2933 AUGUST 2002 INVOICE OPTIONS J K L MIN 1 YEAR 2 2 August-02 COMPANY COST thru 2002 3 25% 4 at $22,789,2991 at $16,632,000 5 1,553,817: 1,134,000 6: 7 1,035,878: 756,000 8: 9 517,939: 378,000 :10 11 1,553,817: 1,134,000 :12 13 1,035,878: 756,000 14 ::15 16 5,697,329: 4,158,000 :17 18 11,611,229' 10,071,900 19 20 21 22 22,789,299 23 5,697,325 24 25 26 27 16,632,000 28 4,158,000 29 30 31 32 $517,939 33 $378,000 34 35 36 equivalent to 55% at $22,789,299 at $16,632,000 3,166,699 2,746,882 2,111,132 1,831,254 1,055,567 915,628 3,166,699 2,746,882 2,111,132 1,831,254 July 3,2002 SH ELL-MCCLU RG-OS2934 DRAFT DRAFT DRAFT ANNUAL MEETING AGENDA TENTATIVE DATES: AUGUST 25-27,2003 LOCATION: ASILOMAR Conference Center + Monterey Peninsula + CA DAY 1 Monday August 25, 2003 Comments 10:00 AM - 2:00 PM Benzene 101 (primary audience: business people) 5:00 PM - 6:00 PM 6:00 PM - Reception with cocktails Dinner 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 DAY 2 Tuesday August 26, 2003 8:30 AM- 4:00 PM Plenary Session Comments All committee members and Consortium guests 6:00 PM - 8:00 PM Dinner 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 DAY 3 Wednesday August 27, 2003 Comments 8:00 AM - 12:00 PM 12:00 PM - 1:00 PM 1:00 PM - 5:00 PM Committee Meetings Lunch Plenary session (breakout sessions) SH ELL-MCCLU RG-052935 Oversight Committee Call Date: Monday, August 5, 2002 Time: 2PM, EDT Dial-in number: 1-866-262-1780 (domestic) 1-205-354-0100 (international) Meeting #: * 0495614 * (stars required) Draft agenda: 1. Communications Update - L. Russo 2. Technical Update - P. Beatty Gov'tlNGO participation proposal Alternate research plan proposal to address potential funding shortfall 3. Recruitment update - P. Beatty 4. Annual research mtg planning update - P. Podhasky logistics draft agenda 5. 2002 invoicing discussion/decision 6. Other business 7. Schedule next call/meeting SH ELL-MCCLU RG-OS2936 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Wednesday, October 12, 20059:05 PM (GMT) benzconsort-tc@listserve.api.org benzconsort-oc@listserve.api.org; benzconsort-cc@listserve.api.org; Howard Feldman <F eldman@api.org> BHRC-TC... In Press: Benzene-Induced Dysplasia BIDS article (LR).pdf BHRC Technical Committee (TC) - The first Shanghai Health Study paper by Richard Irons et al., titled "Chronic exposure to benzene results in a unique form of dysplasia", has been peer-reviewed and accepted for fast-track publication in Leukemia Research. A copy of the 10-page preprint is attached in pdf format. Dr. Irons' suggested that "fast track" likely means imminent publication for this journal. Rich also noted that 2 additional papers have been submitted, but not yet accepted for publication. Best Regards - Bruce. ***** Bruce M. Jarnot, Ph.D., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-OS2937 ELSEVIER Available online at www.sciencedirect.com SCIENCE@DIRECT" Leukemia Research xxx (2005) xxx-xxx LeukemIa Research www.elsevier.com/locate/leukres Chronic exposure to benzene results in a unique form of dysplasia *,Richard D. Irons a, b, c, d, Ling Lv a, e, Sherilyn A. Gross a, c, Xibiao Ye a, b, Liming Bao a, f, Xiao Qin Wanga,e, John Rydera,d, Thomas W. Armstrong g, Yimei Zhou g, Lizhaung Miao b, Anh T. Le c, PatrickJ. Kerzic c, WeiminNih, HuaFua,b a Sino-US Joint Clinical andMolecular Laboratory (JCML), 138 Yi Xue Yuan Road, Fudan University, Shanghai 200032, China b School ofPublic Health, Fudan University, 138 Yi Xue Yuan Road, Shanghai 200032, China c Department ofPharmaceutical Sciences, School ofPharmacy, 4200 East 9th Avenue/Box C238, University ofColorado Health Sciences Center, Denver CO 20262, USA d Department ofPathology, School ofMedicine, AlP Bldg./BoxF768, University ofColorado Health Sciences Center, Denver CO 80262, USA e Huashan Hospital, Shanghai Medical University, No. 12 Wulumuqi Zhong Road, Shanghai 200040, China f Division ofHuman Genetics, University ofCincinnati Children's Hospital Medical Center, 3333 Burnett Avenue, Cincinnati OH 45229-3039, USA g ExxonMobil Biomedical Sciences Inc., 1545 Route 22 East Room LF294, Annandale NJ 08801-0971, USA h Yangpu District Central Hospital, 450 Tengyue Road, Shanghai 200090, China Received 19 July 2005; received in revised form 12 August 2005; accepted 12 August 2005 Abstract Hematotoxicity following chronic benzene exposure has been recognized for over a century, although the mechanism remains unknown. We describe a novel form of bone marrow dysplasia in 23 workers exposed to high concentrations of benzene. Distinguishing features of benzene-induced dysplasia include: marked dyserythropoiesis, eosinophilic dysplasia and abnormal cytoplasmic granulation of neutrophilic precursors. Hematophagocytosis, stromal degeneration and bone marrow hypoplasia are also seen. Severe bone marrow dysplasia is frequently accompanied by clonal T cell expansion and alterations in T lymphocyte subsets. No clonal cytogenetic abnormalities were observed. These results suggest that autoimmune-mediated bone marrow injury is an early or predisposing event in the pathogenesis of benzene-induced persistent hematopoietic disease. 2005 Elsevier Ltd. All rights reserved. Keywords: Myelodysplastic syndrome; Hematotoxicity; Benzene; Immunopathology 1. Introduction Myelodysplastic syndrome (MDS) is a heterogeneous group ofdiseases characterized by ineffective hematopoiesis, dysplasia in one or more hematopoietic lineages, clonal evolution and a tendency to progress on to bone marrow (BM) failure or acute myelogenous leukemia (AML). The etiology and pathogenesis of MDS are unknown, with genetic, infectious and environmental influences variously suggested to playa role in conferring susceptibility to these diseases. * Corresponding author. Tel.: +1 303 315 7170; fax: +1 303 315 7237. E-mail address: richard.irons@uchsc.edu (R.D. Irons). 0145-2126/$ - see front matter 2005 Elsevier Ltd. All rights reserved. doi: 10.1 01 6/j.leulaes.2005.08.01 9 Clonal cytogenetic abnormalities, abnormal cytokine production and immune activation all are prominent features of MDS, and it has been hypothesized that damage to hematopoietic stem or progenitor cells leads to immunologic response directed against antigens in the hematopoietic environment [1-4]. Nevertheless, neither the initial clonal origin of MDS nor the cellular or molecular targets of activated immune cells, or even the order of events in the evolution of the disease have been identified, and a unifying hypothesis for the pathogenesis of MDS in general or for individual subtypes remains elusive. Chronic exposure to benzene is known to result in bone marrow failure and increase the risk of AML [5-7]. Previous LR-2261; No. of Pages 10 SH ELL-MCCLU RG-OS2938 = =-=2 R.D. Irons et al. / Leukemia Research (2005) descriptions of AML associated with occupational exposure to pesticides or solvents that have contained benzene suggest a pattern of disease similar to therapy-related AML (tAML), although direct evidence linking benzene to tAML is lacking [S-11], and the mechanism of benzene-induced hematotoxicity remains unknown. Chronic exposure to high concentrations of benzene has long been associated with aplastic anemia (AA), diagnosed nearly always on the basis of pancytopenia, with hundreds of cases reported during the first half of the 20th century. However, direct evaluation of BM was almost never performed in these cases [12-14]. Although, AA and MDS are thought to be related conditions, MDS is distinguished from other forms of progressive BM failure by the presence of dysplasia and a tendency to progress or evolve into AML. MDS (non-specific) has previously been reported in a very small number of benzene workers who were generally described as having hypocellular bone marrow and dyserythropoietic changes [15]. In contrast, the majority of cases of de novo MDS present with hypercellular BM and abnormal hematopoietic cell morphology, while a hypocellular BM is observed only in a subset of de novo cases. In 2001, the World Health Organization (WHO) published new criteria for the diagnosis of MDS subtypes [ [6]. Dysplasia in one or more lineages is a central diagnostic feature of MDS, although cytopenia, anemia, or pancytopenia, together with BM hypercellularity and a blast cell count <20% are prominent characteristics of most subtypes of the disease. We describe a novel pattern of dysplasia developing in 23 individuals who were previously exposed to high concentrations of benzene. The evaluation of these patients employing current diagnostic and molecular techniques has given us the opportunity to revisit and to further characterize the clinical paradigms associated with benzene-induced hematotoxicity and to examine early events in the pathogenesis of persistent benzene-induced blood disease. Most cases of benzeneinduced dysplasia exhibited BM pathology that was characterized by: hypocellularity, multilineage dysplasia including megaloblastic changes, marked dyserythropoiesis and abnormal granulation in the cytoplasm of maturing neutrophilic precursors and neutrophils. A particular striking feature was a severe dysplasia in eosinophilic precursor cells. Additional findings were consistent with altered inflammatory and immune response, including prominent hematophagocytosis, increases in circulating large granular lymphocytes (LGLs) and altered distribution ofCD4 and CDS T cells which were often accompanied by evidence of clonal expansion ofT cell subpopulations in BM. Significantly, the peripheral blood CBC was nearly normal in approximately 25% of cases. These findings suggest a distinct form ofmultilineage dysplasia in individuals chronically exposed to benzene, and provide evidence for a prominent role for altered immune response in the development of benzene-induced dysplasia. These findings further suggest that routine CBC may not be a reliable monitor for BM injury following chronic exposure to benzene. 2. Materials and methods 2.1. Patients Patients were referred by physicians to Shanghai hospitals based on initial clinical presentation and/or a medical history of benzene intoxication. Participation was voluntary and the framework for consent was obtained according to the Declaration of Helsinki, 2004 and the NIH Common Rule (45 CFR 46). Informed consents were approved by both the Colorado Multiple Institutional Review Board and the Internal Review Board at Fudan University in Shanghai, China. All individuals were administered questionnaires requesting information on medical, occupational and environmental history. A total of 27 subjects employed in the rubber, petrochemical, pharmaceutical, manufacturing or painting industries were referred to our laboratory with a history ofbenzene poisoning. Previous occupational exposure to benzene was independently confirmed by: review of factory industrial hygiene monitoring records, real time quantitative industrial hygiene analysis, including personal samples (n = 325) and breathing zone analyses (n = 225), and/or previous evidence of hydrocarbon intoxication and anecdotal descriptions of solvent use and composition. Benzene from personal samples (3M 3500 organic vapor monitors) and area samples were measured according to the National Institute for Occupational Safety and Health (NIOSH) method with minor changes [17] and were performed using a Finnegan Trace Gas Chromatograph Ultra with a Flame Ionization Detector (FID), autosampIer and SPB-l capillary column (30 m x 0.25 mm x 0.25 m) (Agilent Technologies, Wilmington, DE). Individuals for which quantitative data was available (n = 17) were estimated to have full shift exposures averaging between 50 and 300 parts per million (ppm) benzene for varying periods of time ranging from 6 to 22 years and were removed from exposure an average of 2.7 years prior to evaluation in our laboratory (Table 1). Patients were evaluated for potential confounding factors, including: vitamin B 12, folate or iron deficiencies and viral status (i.e. HCV, HIV). Two patients were excluded due to concurrent iron deficiency, and two patients were excluded because of inability to confirm exposure to benzene. The final study series consisted of 16 females and 7 males with a mean age of 44.4 year (S.D. = 7.S). This represents a small subset of individuals chronically exposed to high concentrations of benzene at the facilities studied. 2.2. Hematology andflow cytometry Peripheral blood (PB), BM aspirates and core biopsies were collected in conjunction with diagnostic procedures and were evaluated in our laboratory. Peripheral blood smears were obtained by finger stick. Enumeration of LGL was performed by visual examination of Wright-Giemsastained smears. Blood samples were collected by venipuncture and processed for routine CBC (CellDyne 3700, Abbott, Park, IL), viral screen (HCV and HIV) (IMx@, Abbott SH ELL-MCCLU RG-OS2939 = =-=R.D. Irons et al. / Leukemia Research (2005) 3 Table I Initial presentation of occupational benzene poisoninga Case Exposure duration (year)b Time since last exposure (month)" Signs/symptomsd Laboratory findingsd 17 26 3 19 4 13 5 ND 6 20 78 8 22 97 10 17 11 ND 12 8 13 7 14 16 15 6 16 15 17 10 18 9 19 15 20 13 21 14 22 18 23 16 48 24 24 48 96 0 3 36 36 24 24 48 48 27 56 36 30 36 24 13 3 9 48 Bleeding, fatigue Bleeding, fatigue, dizziness Bleeding, fatigue ND ND Bleeding, fatigue, dizziness Bleeding Fatigue, dizziness Bleeding, fatigue Bleeding, fatigue ND Bleeding, dizziness Bleeding, fatigue ND Bleeding, infection, fatigue Fatigue, dizziness Bleeding, fatigue, dizziness Bleeding, fatigue, dizziness ND Bleeding, dizziness ND Infection ND Pancytopenia Thrombocytopenia/leukopenia Pancytopenia Granulocytopenia Leukopenia ND Thrombocytopenia Pancytopenia Granulocytopenia/anemia Leukcopenia ND Anemia Pancytopenia Thrombocytopenia Pancytopenia Pancytopenia Leukopenia/thrombocytopenia Pancytopenia ND Leukopenia/thrombocytopenia Leukopenia/thrombocytopenia Leukocytosis Leukopenia/thrombocytopenia a All subjects were originally diagnosed with benzene poisoning according to Chinese occupational health criteria (i.e. a total WBC count <4000 (x 106/1) or 4000-4500 (x 106/1) and a platelet count <80,000 (x 106/1, employment in a factory with documented benzene exposure for at least 6 months and exclusion of other causes for abnormal blood counts). b Duration of chronic exposure to benzene prior to initial complaint. C Time between cessation of benzene exposure and diagnosis of benzene-induced dysplasia in our laboratory. d Signs, symptoms and laboratory findings consistent with hematologic injury documented at the time of exposure. ND indicates information that was not available. Laboratories, Abbott Park, IL), clinical chemistry for liver enzymes (LDH, ALT and AST enzymes) (COBAS, Integra 400 plus, Roche Diagnostics, Shanghai, China) and serum analysis for nutritional factors. Vitamin B12 and folate were measured by chemical luminescence (Beckman Coulter Dxi800), and total iron binding capacity was measured using a Beckman Coulter LX20. BM aspirates and core biopsies were obtained by Jamshidi needle extraction from posterior iliac crest. Aspirates were stained with fluorochromeconjugated antibodies for flow cytometric analysis of BM cellular subsets. Antibody panels included: anti-CD45, CD4, CD8, CD3 (Beckman Coulter, Hialeah, FL; Immunotech, Miami FL). Multiparameter analysis was performed on stained BM cells using a dual laser flow cytometer (FC500, Beckman Coulter) equipped with compensation software (Software CXP, Beckman Coulter). 2.3. Bone marrow morphology BM smears were prepared and evaluated using WrightGiemsa stained preparations and special stains. Core biopsy sections were evaluated using sections stained with Hematoxylin-Eosin, Gomori trichrome, and immunoperoxidaseimmunohistochemistry. Morphology was independently evaluated by two of us (R.D.I., lR.). Dyserythropoiesis was scored on the basis of abnormal nuclear morphology, including internuclear bridging, abnormal budding, multiple nuclei and abnormal mitotic figures or megaloblastoid features. Myeloid or granulocytic dysplasia was defined by nuclear hypolobulation, (i.e. pseudo-Pelger Huetcells, hypersegmentation, abnormal mitotic forms) either hypo- or hypergranulation of the cytoplasm as well as the presence oflarge irregular granules. Megakaryocyte dysplasia was defined by non-, or hyper-lobulated nuclei, multiple individual nuclei or the presence of prematurely segmented or "shedding" cytoplasm. Eosinophilic dysplasia was defined by the presence of megaloblastoid features and abnormal cytoplasmic basophilic and eosinophilic hypergranulation. Microscopic analysis was performed using an Olympus BX5l bright field microscope (Olympus Optical, Ltd., Tokyo, Japan) equipped with a Sony EXwave HAD color video camera (Sony Ltd., Tokyo, Japan). Images were processed using software custom designed for the purpose (Vision Image Technology, Shanghai, China), and photomicrographs were cropped and edited using Adobe Photoshop (San Jose, CA). Cases of benzene-induced dysplasia were compared to MDS subtypes diagnosed according to the WHO classification system 2.4. Cytogenetic analysis Fluorescence in situ hybridization (FISH) and cytogenetic analyses were performed on unstimulated BM cells SH ELL-MCCLU RG-052940 = =-=4 R.D. Irons et al. / Leukemia Research (2005) following 24-72 h of culture. Chromosomes were prepared and G-banding after trypsin was performed according to standard techniques. If possible, 29 metaphases were analyzed. Interphase or metaphase FISH analyses were performed on the short-term cultured cells or metaphases prepared from the BM or PB samples. All probes used in the FISH studies were purchased from Vysis (Downers Grove, IL). Sample preparations and hybridizations were performed according to the protocols provided by the manufacturer. Slides were viewed using an Olympus fluorescence microscope (Olympus Optical, Ltd., Tokyo, Japan) equipped with the appropriate filters and the PowerGene Macprobe image analysis system (Applied Imaging International Ltd., Newcastle, UK). Whenever possible, 1000-2000 nuclei were analyzed for each probe and scored by two readers. Signal patterns for each probe were compared against a reference range established from analysis of 100 samples from individuals with no evidence of clonal disease or previous benzene exposure. 2.5. Analysis ofFLT3 mutations FLT3 mutations are often encountered genetic abnormalities in AML, frequently involving an internal tandem duplication (lTD) or activation loop mutations in the tyrosine kinase domain (TKD) of the FLT3 gene [18,19]. FLT3 mutations were determined by PCR analysis and sequencing using DNA isolated from BM cells. Genomic DNA was isolated from blood and BM samples using A Qiagen QIAmp DNA mini Kit (Chatsworth, CA) according to the manufacturer's directions. Exons 14 and 15 and the intervening sequence intron of the FLT3 gene were amplified by PCR to detect lTD. The PCR products were run on both 2% agarose gel and 5% polyacrylamide gel. Exon 20 of the FLT3 gene was also amplified by PCR to detect TKD using primers as reported by Yamamoto et al. [20]. These PCR products were subjected to digestion by EcoRV and analyzed on a 3.5% agarose gel. Finally, PCR products were isolated from the gels using the DNA Recovery Kit (Biologic Technology Co., Ltd., Shanghai, China) and directly sequenced on an ABI 377 DNA Sequencer (Applied Biosystems, Foster City, CA). 2.6. T cell receptor (TCR) rearrangement analysis Detection of clonal and oligoclonal expansion of T cell populations was determined by analysis of rearrangements ofTCR beta (TCR~), TCR gamma (TCRy) and TCR delta (TCRo) genes by multiplex PCR using BIOMED-2 kits (InVivoScribe Technologies, San Diego, CA) according to the manufacturer's protocol. For the TCR{J gene, the kit comprised ofthree individual master mix reactions, the TCRy kit utilized two master mixes and TCR8 kit utilized a single PCR master mix. Amplification of TCR{J, y and 8 genes was performed in a thermocycler and the PCR samples were loaded unto a 6% non-denaturing polyacrylamide TBE gel, stained with ethidium bromide, visualized by UV illumination and documented by digital photography. Clonal rearrangements were determined according to published guidelines with exclusion of nonspecific bands [21]. 3. Results Patients diagnosed with benzene-induced dysplasia exhibited a distinct set of characteristic features that both overlap with and can be distinguished from standard classifications of MDS. At the time of diagnosis in our laboratory, PB findings in these cases included pancytopenia (n = 1), and cytopenias, singly or in combination (n = 16). The most consistent abnormal finding was lymphocytopenia (n = 14). Six subjects presented with normal or marginally normal blood counts Crable 2). All patients exhibited significantBM pathology including evidence of multilineage dysplasia which was characterized by macrocytic megaloblastic changes in granulocytic, eosinophilic as well as erythroid lineages and at all stages ofdevelopment. Stromal degeneration was also present in 12/23 cases. Most cases of benzene-induced dysplasia were hypocellular (17/23) with residual hematopoietic cells unevenly distributed throughout the BM. Dyserythropoiesis was commonly found and often severe (Figs. 1 and 2). Several features distinguished benzene-induced dysplasia from other previously defined subtypes of MDS including therapy related (t)MDS [16,22,23]. Prominent among these were the presence ofabnormal BM eosinophilic precursor cells (22/23 cases). These cells are reminiscent of those found in AML with the 16(p13;q22) chromosome abnormality [16] (Fig. 3). Hematophagocytosis, which is commonly associated with a poor prognosis in BM failure, was a particularly frequent and striking observation (16/23 cases) (Fig. 4). Maturing myeloid cells and granulocytes also typically exhibited megaloblastic alterations and abnormal cytoplasmic morphology (18/23 cases) (Fig. 5). Finally, for a significant subset of cases there was a lack of concordance between the severity of pathology observed in the BM and the relatively mild or moderate abnormalities encountered in the PB (6/23 cases). This suggests that monitoring of the peripheral blood CBC may not accurately reflect the progression of hematopoietic disease in patients previously exposed to benzene. 3.1. Clonal cytogenetic abnormalities in benzene-induced dysplasia Reoccurring clonal genetic abnormalities are frequently encountered in MDS, and have been suggested to play an early or predisposing role in the development of the disease. Therefore, we analyzed BM cells from each subject for evidence of clonal hematopoietic lesions. In contrast to the overall frequency of cytogenetic abnormalities observed for MDS in our laboratory (26%; n = 100), cytogenetic analyses revealed no clonal abnormalities in any benzene poisoning case in this series. The most frequent cytogenetic abnormalities encountered in tMDS/tAML are -5, -7, del(5q)-, and del(7q-) which are found in greater than 70% of reported SH ELL-MCCLU RG-OS2941 = =-=R.D. Irons et al. / Leukemia Research (2005) 5 Table 2 Characteristics of PB and BM in benzene-induced dysplasia Case ANC (106/1) ALC (106/1) LGL (%) PLT (109/1) Hgb (g/dl) Bone marrow Cellularity CD4/CD8 Ratio Stro Dysplasia HP Gran Ery Meg Eo 1240 2 1920 3 1250 4 1520 5 930 6 2980 7 1760 8 1590 9 3390 10 1650 11 1510 12 3140 13 2020 14 2380 15 2080 16 2270 17 2370 18 2950 19 2240 20 1400 21 2090 22 4000 23 1520 730 1620 1390 980 1530 190 340 2220 1740 1440 1160 823 2300 1600 1710 1780 1350 710 870 600 810 2850 990 27 15 28 20 24 25 32 40 41 46 30 42 41 28 30 32 28 18 18 32 22 33 ND 93.7 11.5 Norm 0.24 122 11.9 Hypo 1.62 176 13 Hypo 0.92 200 13.5 Norm 0.76 61.8 15.9 Hypo 2.42 77.8 13.9 Norm 0.60 124 8.3 Hyper 0.64 146 13 Hypo 0.59 203 13.3 Hypo 0.71 168 12.9 Hypo 0.45 122 12.7 Hypo 0.43 92.7 11 Hypo* 0.42 133 11.8 Hypo* 0.97 174 15.2 Hypo 0.69 65.9 12 Hypo 0.83 137 13.8 Hypo 0.71 71.1 11.8 Hypo 0.37 113 12.8 Hypo 0.91 33.5 11.4 Hypo 0.20 84.1 12.9 Hypo 0.59 99.8 11.9 Hypo 1.39 275 14.7 Hyper* 0.88 147 13.2 Norm 0.50 N + ND ND N ND + ++ N +++ +++0 N +++ ++ ++ N ++ +++ 0 SA 0 +++ 0 N +++ +++ +++ SA ND + 0 SA +++ +++ +++ FN ND + + SA + +0 QNS +++ 0 0 QNS 0 00 SA + +0 SA +++ + 0 N ++++++0 SA ++++ 0 SA +++ + 0 SA +++ +++ 0 SA +++ +++ 0 SA ++++ 0 0++++ 0 SA + +0 + +++ ++ +++ + ++ ++ +++ +++ ND +++ ++ +++ +++ ++ + + +++ ++ + NDND +++ ND +++ ND +++ ND +++ ND ++ ++ ND ++++ +++ + ++ +++ ++ + ++ + ++ ANC, absolute neutrophil count; ALC, absolute lymphocyte count; LGL, large granular lymphocytes (%ALC); PLT, platelet count; Hgb, hemoglobin; bone marrow cellularity was estimated from the core biopsy or the aspirate* (e.g. hypo-hypoplastic [<40% cellularity], norm-normal [40--{)0% cellularity] and hyper-hyperplastic [>60% cellularity]; BM lymphocyte CD4/CD8 ratios as determined by flow cytometry; Stro, stroma; SA, focal serous atrophy; FN, fibrinoid necrosis, 0, stromal cells were absent or too rare to evaluate; dysplasia was estimated for granulocytic (Gran), erythroid (Ery), megakaryocytic (Meg) and eosinophilic (Eo) lineages and scored based on the percentage of lineage-specific cells involved, ND [none detected], + [10-50%], ++ [50-70%], or +++ [>70%]).0, cells of individual lineage were absent or too rare to evaluate for dysplastic changes. HP, hematophagocytosis, was scored as not detected (ND) present (+), moderate (++) or severe (+++). Reference ranges: ANC (2000-7000 x 106/1); ALC (1600--{)000 x 106/1); LGL (5-15%); PLT (100-300 x 109/1); Hgb (12-16 gldl); CD4/CD8 (0.72-2.56) [55]. Fig. 1. Erythroid dysplasia and dyserythropoiesis in benzene-induced dysplasia. Abnormal erythroid cells exhibit megaloblastic abnormalities and abnormal nuclear morphology including nuclear bridging. BM aspirate slides stained with Wright-Giemsa (original magnification 1000 x). SH ELL-MCCLU RG-OS2942 = =-=6 R.D. Irons et al. / Leukemia Research (2005) Fig. 2. Prominent dyserythropoiesis in a core biopsy from a representative patient with benzene-induced dysplasia. The most frequent dyserythropoietic changes in H&E stained sections are bizarre budding of nuclei in erythroid precursor cells. Core biopsy section stained with Hematoxylin-Eosin (original magnification IOOOx). Fig. 3. Abnormal eosinophilic precursor cells in benzene-induced dysplasia. Abnormal eosinophils exhibit megaloblastic nuclear abnormalities, nuclear hypersegmentation and atypical giant basophilic and eosinophilic cytoplasmic granulation. BM aspirate slides stained with Wright-Giemsa (original magnification IOOOx). cases [24,25], and some studies have suggested a similar pattern might exist for AML developing after chronic benzene exposure [10,26-28]. We also performed additional analyses for -7, 5q-, 11q23 and +8 structural abnormalities using FISH and observed no signals above background (data not shown). FLT3 mutations are the most frequently encountered genetic abnormalities in AML, commonly involving lTD or activation loop mutations in the TKD ofthe FLT3 gene [18,19,29]. However, no FLT3 mutations were observed in this series. These findings suggest that acquisition of cytogenetic or molecular abnormalities in benzene-induced dysplasia may be relatively late events in the neoplastic progression of the disease. 3.2. Benzene-induced dysplasia may involve an autoimmune process The frequency and severity oflymphocytopenia, hematophagocytosis and eosinophilic dysplasia in benzene-induced dysplasia led us to examine additional immune cell parameters. Patients with benzene-induced dysplasia exhibited relative increases in LGL (mean = 29.6%, n = 22) in PB and decreases in the ratio ofCD4+/CD8+ lymphocytes in the BM (0.77 0.48, n = 23) (Table 2). These observations coincided with demonstration of clonal and oligoclonal proliferations in BM T lymphocytes (14/23 cases), including clonal rearrangements in V~ TCR gene segments (n = 4), Vo TCR gene segments (n = 6) and both V~ and Vo TCR segments (n = 4). 4. Discussion The role of autoimmune mechanisms in the development ofMDS remains largely unexplored, although, evidence is accumulating to implicate immunologic abnormalities in the pathogenesis of the disease. Frequent findings in MDS include lymphocytopenia, inverted CD4/CD8 T cell ratios, increases in cytotoxic CD8+ T cells (CTL) and serum levels of inflammatory cytokines such as tumor necrosis factor a (TNF-a), and interferon -y (INF--y) [2], abnormal expression ofHLA-DR [30] and evidence ofTCR gene rearrangements [31-34]. Positive clinical responses to immunosuppressive therapy with anti-thymocyte globulin (ATG) or cyclosporin A also have been reported in some patients with MDS [3,33,35], together with treatment-related decreases in both CD8+ T cell clones and T-LGL [32,36,37]. The role of environmental exposure in the evolution ofMDS is unknown, although it has been hypothesized that the pathogenesis ofMDS may involve SH ELL-MCCLU RG-052943 = =-=R.D. Irons et al. / Leukemza Research (2005) 7 Fig. 4. Hematophagocytosis in benzene-induced dysplasia. Activated histiocytic cells within the BM exhibit prominent phagocytosis of degenerating erythroid and granulocytic cells which is indicative of an immuno-reactive inflammatory process. The histiocytes themselves do not appear atypical and generally exhibited a low nuclear cytoplasmic ratio with small nuclei containing condensed chromatin. BM aspirate slides stained with Wright-Giemsa (original magnification 1000x). damage to hematopoietic progenitor cells exposed to intrinsic or environmental toxic agents that might lead to immunologic suppression of cell growth and maturation [2,38]. Transient anemia, cytopenias and dysplasia frequently occur in BM toxicity during or immediately following exposure to toxic agents. This usually is not associated with persistent disease and therefore, is not generally considered to be MDS [39-41]. However, our findings show that prolonged chronic exposure to high concentrations of benzene results in the development of a distinct form of dysplasia that differs from commonly defined subtypes of MDS and that can persist for years after cessation of benzene exposure. Previous proposals to explain benzene carcinogenesis, including those from our laboratory, have presumed a role for genetic inj ury in the origin ofbenzene-induced persistent toxicity and the development ofAML [28,42-44]. Alternatively, our current results suggest the possibility that an autoimmune process may precede the acquisition of frank structural cytogenetic abnormalities and may be a predisposing event in the development ofpersistent BM disease following benzene exposure. Histological manifestations of benzeneinduced dysplasia include multilineage dysplasia including severe dyserythropoiesis, stromal degeneration, alterations in BM T lymphocyte subsets, abnormal eosinophilic precursors and hematophagocytosis. Hematophagocytosis is associated with severe viral infection or inflammatory response and activation of immune cells [45]. Benzene-induced dysplasia is also accompanied by clonal and polyclonal proliferation ofT Fig. 5. Dysplastic changes in granulocytes in benzene-induced dysplasia. The BM and PB in the case series typically contain maturing myeloid cells with megaloblastic, hypo-segmented (pseudo Pelger-Huett) or hypersegmented nuclei. In some instances abnormal mitotic figures are present in granulocytes with mature cytoplasm. Cytoplasmic abnormalities include protruding pseudopodia which often trails cell bodies and abnormal cytoplasmic granulation in which large granules were unevenly distributed in clusters or marginated directly beneath the plasma membrane. BM aspirate slides stained with Wright-Giemsa (original magnification 1000 x). SH ELL-MCCLU RG-OS2944 = =-=8 R.D. Irons et al. / Leukemia Research (2005) lymphocytes in the BM which is indicative of an active immune process and has been described in a variety of immune-related conditions involving suppression of hematopoiesis including MDS [4,46,47]. The function of'yo T cell subsets is largely unknown, although increases in -yo T cells also have been observed in patients with BM failure, have been shown to modulate eosinophilic inflammation in other tissues and are known to be activated by TNF-a [35,37,48,49]. In this study, TCR8 expansions were accompanied by evidence of corresponding expansion of TCRy gene rearrangements. However, confirmation of -yo T cell subsets by heteroduplex analysis is required. These observations indicate that previous chronic exposure to benzene is associated with the development of BM dysplasia, and suggest that a reactive inflammatory process may be involved in the suppression of hematopoiesis in persistent BM failure following chronic benzene exposure. These findings further suggest the possibility that markers of immune activation or inflammation may prove useful in monitoring the development or progression of benzeneinduced dysplastic disease. Nevertheless, the role of altered immune regulation in the pathogenesis of benzene-induced dysplasia, as well as the identity of any putative antigens remain a mystery. The mechanisms of benzene-induced hematopoietic cell injury are not completely understood. However, a subpopulation of CD34+ BM cells that are responsive to granulocyte-macrophage colony-stimulating factor (GM-CSF) have been implicated as targets. Studies in our laboratory have shown that the benzene metabolite, hydroquinone, enhances cytokine-dependent clonal proliferation of a subpopulation of GM-CSF-responsive human CD34+ BM cells which appears to be mediated via the extracellular signal-regulated kinase/activation protein-1 signaling pathway (ERKlAP-1) [50--53]. Independently, hydroquinone also synergizes with TNF-a to produce apoptosis in human CD34+ hematopoietic progenitor cells (HPC) via a mechanism that involves the inhibition ofNF-KB [54]. In recent years occupational exposure to benzene in China has been significantly reduced with the current Chinese occupational exposure limit being 1.9 ppm as a time weighted average (TWA) with a short-term exposure limit (STEL) of 3.2 ppm. Despite these changes, exposures to high concentrations of benzene continue to occur, and subjects diagnosed with persistent BM dysplasia in this report represent only a small fraction of the individuals exposed to high concentrations of benzene in the facilities studied. Previous reports have suggested that genetic polymorphisms in metabolizing and detoxification enzymes may playa role in conferring susceptibility to benzene toxicity. However, preliminary results in our laboratory do not suggest a prominent role for these genetic variants in the development of benzene-induced BM dysplasia. Evaluation of the influence of polymorphisms in other genes, such as TNF-a, on susceptibility to benzeneinduced BM dysplasia are ongoing in our laboratory. Continued characterization and follow-up of these subjects with benzene-induced dysplasia may provide insights into early events associated with the pathogenesis, clonal selection and progression of persistent BM disease, including MDS and its potential progression to AML. Acknowledgments This work was funded by a grant from the Benzene Health Research Consortium and was conducted in cooperation with the Shanghai Hematology and Pathology Societies. We would like to thank the patients and the physicians who participated in our study. The participating hospitals included Huashan Hospital, Xinhua Hospital, Long March Hospital, Huang Pu Central Distract Hospital, Renji Hospital, Ruijin Hospital, Huadong Hospital, Jin An Central Hospital, No.1 People's Hospital, No.5 People's Hospital, No.6 People's Hospital, No.9 People's Hospital, Yang Pu Central Hospital, Zha Bei Central Hospital, Shu Guang Hospital, Chang Ning Central Hospital, Tong Ji Hospital, Shong Jin Central Hospital, Zhong Shan Hospital, Railway Hospital, Rong Hua Hospital, Changhai Hospital, Occupational Disease Hospital, Jiading Central Hospital, 455 Hospital, Shidong Hospital, No.1 Baoshan Hospital, and Putuo Central Hospital. The authors gratefully acknowledge Dr. Philippa Marrack for helpful discussion. We would also like to extend appreciation to Allan Holsomback, and Mingde Ouyang for database management and Ann Louden, Junfang Xie and Jiamin Liu for manuscript and clerical assistance. 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[39] Steensma DP, Tefferi A. The myelodysplastic syndrome(s): a perspective and review highlighting current controversies. Leuk Res 2003;27:95-120. [40] Aul C, Germing U, Gattermann N, Minning H. Increasing incidence of myelodysplastic syndromes: real or fictitious? Leuk Res 1998;22:93-100. [41] Heaney ML, Golde DW. Myelodysplasia. N Engl J Med 1999;340: I 649--{i0. [42] Stillman WS, Varella-Garcia M, Irons RD. The benzene metabolite, hydroquinone, selectively induces 5q31-and-7 in human CD34+CDI9- bone marrow cells. Exp HematoI2000;28:169-76. [43] Smith MT, Zhang LP, Jeng M, Wang YX, Guo WH, Duramad P, et al. Hydroquinone, a benzene metabolite, increases the level of aneusomy of chromosomes 7 and 8 in human CD34-positive blood progenitor cells. Carcinogenesis 2000;21: 1485-90. [44] Smith MT, Zhang LP, Wang YX, Hayes RB, Li GL, Wiemels J, et al. Increased translocations and aneusomy in chromosomes 8 and 21 among workers exposed to benzene. Cancer Res 1998;58:2176-81. [45] Jordan MB, Hildeman D, Kappler J, Marrack P. An animal model of hemophagocytic lymphohistiocytosis (HLH): CD8+ T cells and interferon gamma are essential for the disorder. Blood 2004;104:73543. [46] O'Keefe CL, Plasilova M, Wlodarski M, Risitano AM, Rodriguez AR, Howe E, et al. Molecular analysis of TCR clonotypes in LGL: a clonal model for polyclonal responses. J Immunol 2004;172:19609. SH ELL-MCCLU RG-052946 = =-=10 R.D. Irons et al. / Leukemia Research (2005) [47] Callan MF, Fazou C, Yang H, Rostron T, Poon K, Hatton C, et al. CD8(+) T-cell selection, function, and death in the primary immune response in vivo. J Clin Invest 2000; I 06: 1251--{) 1. [48] Hahn YS, Taube C, Jin N, Sharp L, Wands JM, Aydintug MK, et al. Different potentials of gamma delta T cell subsets in regulating airway responsiveness: V gamma I + cells, but not V gamma 4+ cells, promote airway hyperreactivity, Th2 cytokines, and airway inflammation. J Immunol 2004;172:2894-902. [49] Kanehiro A, Lahn M, Makela MJ, Dakhama A, Fujita M, Joetham A, et al. Tumor necrosis factor-alpha negatively regulates airway hyperresponsiveness through gamma-delta T cells. Am J Respir Crit Care Med 2001;164:2229-38. [50] Irons RD, Stillman WS, Colagiovanni DB, Henry VA. Synergistic action of the benzene metabolite hydroquinone on myelopoietic stimulating activity of granulocyte/macrophage colony-stimulating factor in vitro. Proc Natl Acad Sci USA 1992;89:3691-5. [51] Irons RD, Stillman WS. Cell proliferation and differentiation in chemical leukemogenesis. Stem Cells 1993;11 :235-42. [52] Irons RD, Stillman WS. Impact of benzene metabolites on differentiation of bone marrow progenitor cells. Environ Health Perspect 1996;104(Suppl. 6):1247-50. [53] Zheng JH, Pyatt DW, Gross SA, Le AT, Kerzic PJ, Irons RD. Hydroquinone modulates the GM-CSF signaling pathway in TF-I cells. Leukemia 2004:1-9. [54] Kerzic PJ, Pyatt DW, Zheng JH, Gross SA, Le A, Irons RD. Inhibition of NF-kappaB by hydroquinone sensitizes human bone marrow progenitor cells to TNF-alpha-induced apoptosis. Toxicology 2003;187:127-37. [55] Jiang W, Kang L, Lu HZ, Pan X, Lin Q, Pan Q, et al. Normal values for Cd4 and Cd8 lymphocyte subsets in healthy Chinese adults from Shanghai. Clin Diagn Lab Immunol 2004;11:811-3. SH ELL-MCCLU RG-OS2947 From: Sent: To: Cc: Subject: Bruce Jarnot <jarnotb@api.org> Thursday, October 20,20052:28 PM (GMT) Guilan Li <guilanli@263.net.cn> Jmricewas@ao1.com; Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com> SRPIERP Conference Call: Fri 21 Oct, start time: 10:00 pm By copy to Shan ?May I ask a big favor? Would you please call Guilan Li, in case I may have mis-communictated these directions? Thank you! Dear Guilan Li 70: p> Please join the SRPjERP discussion tomorrow (Friday, October 21), at 10:00 PM local China time, by calling the United States: (770) 765-9147, and then entering conference code: 202-682-8319# Day/Date: Friday, October 21 Start Time: 10:00pm China Telephone number: 770-765-9147 Access code: 202-682-8319# Best Regards - Bruce. From: Guilan Li [mailto:guilanli@263.net.cn] Sent: Wednesday, October 19, 2005 8:57 PM To: Bruce Jarnot; benzene-srp@listserve.apLorg; benzene-erp@listserve.apLorg Subject: Re: .. Conf Call: Fri 21 Oct, 7:00 AM.available for me Importance: High Bruce Jarnot, 1~~f! It can be reached at 7 Am for Guilan Li at 86-10-83157363 (H). Thanks Li Guilan ======== 2005-10-1904: 43: 47 1~fr*1r:p ~jj[: Shanghai Health Study ERP/SRP members - SRP and ERP Panels will meet by conference call on Friday, 21 October 710cal start times listed below 7with Jerry Rice, for pre-annual meeting update (see Agenda, below). Thank you for your feedback on availability for this call; schedules were heavily conflicted, however, and unfortunately no date worked well for everyone; SH ELL-MCCLU RG-052948 Date: Friday, October 21 st Start time: 7:00 AM 10:00 AM 4:00 PM 10:00 PM PDT Pacific Daylight Time EDT Eastern Daylight Time CEST Central European Summer Time Shanghai China Time Telephone number: 770-765-9147 (or US toll-free: 866-443-0059) Access code: 202-682-8319# Agenda: 1. Mid-year progress reports (previously distributed; also available from SHS web site): -- Dr. Wong (Case Control report); -- Dr. Irons (Disease Progression &Molecular Epidemiology report); -- Dr. Fu (Exposure Assessment report); 2. Jerry Rice visited Fudan University briefly during September, by invitation, chiefly to see the future home that is being prepared for the Joint Clinical and Molecular Laboratory after consortium funding ends in December 2006. He will report on his visit, and on the current status of the standing proposal to the Consortium that all members of the Panels conduct a site visit to Shanghai; 3. Consortium request that the Panels review t~rogress to date?in light of original approved protocols; 4. Draft program for Nov. 1-3 Annual Research meeting (file attached). Best Regards - Bruce. ***** Bruce M. Jarnot, Ph.D., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-052949 Guilan Li guilanli@263.net.cn 2005-10-20 SH ELL-MCCLU RG-052950 From: Sent: To: Cc: Subject: Bruce Jamot <jamotb@api.org> Wednesday, October 5, 20055:49 PM (GMT) benzconsort-tc@listserve.api.org; Jmricewas@aol.com benzconsort-oc@listserve.api.org; benzconsort-cc@listserve. api. org BHRC-TC... *REMINDER* ConfCall: Fri 07 Oct, 3:30pm EDT BHRC Technical Committee (TC) - REMINDER We have a TC Conference Call scheduled on Friday, October 7th at 3:30pm Eastern Daylight Time ... AGENDA -- Discuss Shanghai / Fudan site visit with Dr. Jerry Rice -- Review 3 mid-year Progress Reports -- Manuscript Review - revised proposal (see below) CONFERENCE CALL Date: Fri, 07 Oct Time: 3:30 Eastern (2:30pm Central, 12:30pm Pacific) Dial in: 1-770-765-9147 PIN: 2026828319# NEW AGENDA ITEM - M'SCRIPT REVIEW Michael Bird recommends that the TC consider alternate timing for sponsor review of SHS publications, suggesting that Shanghai Health Study (SHS) Investigators submit finished manuscripts to study sponsors after acceptance for publication, rather than "after scientific review and two weeks prior to submission for publication" as currently stated in the DP and ME protocols (excerpted below). Benefits include: 1) Scientific independence of the study may be further enhanced by isolating sponsors from any opportunity to preview manuscripts before they are accepted for publication; 2) Additional isolation of study sponsors may further limit potential disclosure of unpublished information, should manuscript review suggest the need for TSCA 8(e) health effect reporting. SHELL-MCCLURG-052951 3.2 DeliYerables A Publication", The principal product ofthis study s]mH be the generation ofl'epmts tob~ published in th<;! t\,- N1' c't'" *;','" t,,) ",'"-::>l'l(i 'Fd ';');;'1'11'l~l~"~'>.'r'.'.''~t"'"j,<":,''v.';.t"~"\':''';r.,'i'!,o:''''i(..1...."..'./.,.;';~."~".;~,:;l~.t...1.,'' ...'Ii,. l;t~.<~t.~"!,1..t>...j~,t..,~.to<b',;*~",~ 1).... ~'!C...tt'I;.'";"'l:;,;~~I~C'l."l.'. . I:~ 'A (~ .. Ill;':"")'" p:<>'1'('Ih~ ,~. ~'~1"l(~<;'"<; :A1.L~,,i . ..-.J ," ~'1"'~;~'~"""'''''' JiJ.. .;t ~.... :!o.o!o t~'.)'"""".~ .. ~...\ .... '. 'r " " "'!of. P""I,l,"I'"'ll)l'l'l't.r':<>('t: r'{"- .', 11<>4\',;"":\;-,, ,-,.,'1\'1' ":'" *:'1'..... ,.,' .1,. ......' <;:... ~ t.1~.l"'\.~.'. '~'!:,"nh'f<.'''-'''~ ~-l.,.- ..... J.~,~).\:.., :C''\....... .,< ...... ,,~ ('. r."," f~}l:I.).'l" """"'" O"l,iI~, "t'.;0:l"tl,'~r.t.. 'l."', -",..".. o,;,J...... \,.. ....... ('0~,1"..'""/.'..l, <;l~;"~:~.:,.;:<::';-:..~..,..~...~.,:t<..;"",''i. ""'t.~,,'(.;;.r'><:'.l~i."..'~;..l< .~ ....., , .submission for l,mblic,aticHl, US rel~:.miatorvJ concerns about IJoblishing~ indus!rv~ ~5D~ OnS("red studies most often focus-on the ind<J')endence clf studv investig~ ators, Fillished manuscrh~Hs ~viH b-e furnished to Study Spom::ors aftefscientific revie\v and t\VO weeks. prior to submission fOf publication, In any event the 1'1n31 decision. to edit or submit a manuscript for ptl.t>hcatioll \vill l'''i.',.',.',"'"'l'{~le l,tex.".. l'1;:,,:.'l'"I.'.l:~"~''(", "'-,.L..J "'"H-'1"h~.~_,... :f:h;:.,I-.l'>:.......P.. l"';l".l"l."..'.!..:,1-,.,.:1":.:.. 1i I'l'.'.:1',:c'\; P'tw'o''o'tJ1'' O~(.'"[,tOl'~ Best Regards - Bruce. SH ELL-MCCLU RG-OS29S2 From: Sent: To: Subject: Attach: Matt Todd <ToddM@api.org> Friday, September 30, 2005 6:39 PM (GMT) benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsortcc@listserve.api.org BHRC Sept. 12 Conference Call Minutes 2005-09-12_bhrc_oversight_minutes_draft. doc BHRC Committee Members: Please review the attached draft minutes from the September 12th conference call and send comments to me by COB October 14th. Regards, Matt Matthew Todd American Petroleum Institute 1220 L Street NW Washington DC 2005 www.api.org SH ELL-MCCLU RG-052953 From: Sent: To: Cc: Subject: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Tuesday, November 8, 2005 11 :05 PM (GMT) Richard Irons (E-mail) <richard.irons@uchsc.edu> Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Michael Johnston (E-mail) <Mike.dJohnston@ConocoPhillips.com>; Cagen, Stuart Z SCC-DCSI261 <sc724012@shell.com>; Twerdok, Lorraine (E-mail) <twerdokl@api.org>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Jennifer Galvin (E-mail)<jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail) <russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Colletti, Sarah J SCC-DCSI14 <sarah.colletti@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobil.com>; Richard Herold (E-mail)<heroldra@bp.com>; Valerie Crissey (E-mail)<vcrissey@chevrontexaco.com> Shanghai Health Study Annual Meeting - Thanks Richard, On behalf of the Benzene Health Research Consortium, I want to extend our thanks for your participation in the SHS Annual Meeting and symposium. We appreciated your presentations and the opportunity to engage with you. Please extend our best wishes to your staff. We look forward to hearing about the continuing progress of the study. ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SH ELL-MCCLU RG-052954 From: Sent: To: Cc: Subject: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Tuesday, November 8, 2005 11 :04 PM (GMT) Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Matthew Todd (E-mail) <toddm@api.org>; Howard Feldman (E-mail) <feldmanh@api.org>; Lorraine Twerdok <twerdokl@api.org> Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Michael Johnston <Mike. dJohnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Jennifer Galvin (E-mail)<jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail) <russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SCC-DCSI261 <sc724012@shell.com>; Colletti, Sarah J SCC-DCSI14 <sarah.colletti@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com> Shanghai Health Study Annual Meeting - Thanks Dear API Staffers; On behalf of the BHRC, I wish to extend our appreciation for your support in organizing the 3rd annual meeting of the SHS. Thanks for all your hard work. ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SH ELL-MCCLU RG-052955 From: Sent: To: Cc: Subject: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Tuesday, November 8, 2005 11 :04 PM (GMT) Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Michael Bird (E-mail) <michael.g.bird@exxonmobil.com>; 'stephen.m.bowes@exxonmobil.com' Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Donald M. Burnett PhD (E-mail) <burnetdm@bp.com>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail)<russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SCC-DCSI261 <sc724012@shell.com>; Colletti, Sarah J SCC-DCSI14 <sarah.colletti@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com>; Brian Doll (E-mail)<brian.e.doll@exxonmobil.com>; Michael Johnston (E-mail)<Mike.dJohnston@ConocoPhillips.com>; Twerdok, Lorraine (E-mail) <twerdokl@api.org>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com> Shanghai Health Study - Thank You XOM for Hosting On behalf of the BHRC, I wish to extend our thanks and appreciation to ExxonMobil for hosting the Shanghai Health Study annual meeting. The facility and food were excellent. I know that many at XOM contributed and we want you to know that all the efforts help to contribute to a successful meeting. Lynn, please extend our thanks to Mona. ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SH ELL-MCCLU RG-052956 From: Sent: To: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Wednesday, July 6, 2005 12:51 PM (GMT) benzconsort-tc@listserve.api.org; Jerry Rice (E-mail)<Jmricewas@ao1.com> BHRC-TC... ConfCall wi Dr. Rice - Thur 07 Jul, 3:00pm EDT Letter to PIs & Panels re Nov 4 Public Meeting.doc BHRC Technical Committee (TC) - Seems we left last Thursday's DC call with some confusion regarding the new date! time for the Tech Committee conference call with Dr. Rice... so with a nod of assent from our Chair, we will convene a TC conference call tomorrow afternoon with Jerry Rice, to discuss the November 4th SHS Symposium at the Georgetown University Conference Center in Washington DC. Please review the attached draft letter before the call; this updated version includes proposed revisions from Lynn Russo, intended to further clarify roles & responsibilities of industry sponsors! API! Pis. AGENDA -- revised draft letter to speakers (attached file) -- agenda discussion -- presentations -- roles & responsibilities CONFERENCE CALL Date: Thursday, July 7th Time: 3:00pm Eastern (2:00pm Central, 12:00pm Pacific) Dial in: 1-770-765-9147 PIN: 2026828319# Thank you! Bruce. SH ELL-MCCLU RG-OS29S7 DRAFT 30 June 2005 SHANGHAI HEALTH STUDY Jerry M. Rice, PhD Chair, Scientific Review and (2005) Ethics Review Panels 3213 Coquelin Terrace Chevy Chase, Maryland 20815 Tel: +1-301-986-0659 Fax: +1-301-986-5438 E-mail: jmricewas@aol.com [date] Public Symposium to describe the Shanghai Health Study Georgetown University, Washington, DC 4 November 2005 To: Senior Investigators, Shanghai Health Study Members, Ethics Review Panel Members, Scientific Review Panel Dear Colleagues, As you know, we have all been very interested in ensuring those potentially interested in the Shanghai Health Study (SHS) learn about its scope, structure and objectives before the research program is completed and final results are published. Your presence in the Washington area for the 2005 Annual Meeting provides an opportunity to convene a forum here to which non-SHS researchers and scientific staff of various U.S. Government agencies will be invited. The study sponsors have asked me to organize such a symposium. Facilities suitable for the Symposium are available in the Leavey Conference Center at Georgetown University on Friday, November 4, the day after the Annual Meeting in Fairfax, Virginia. The Symposium would begin in the morning with a continental breakfast for all participants and conclude in the early afternoon. The principal purpose of this first letter is to advise you of these plans and to request that you plan to extend your visit to the Washington area one day beyond the conclusion of the Annual Research Meeting in order to attend and, where appropriate, participate actively in the Symposium. The Symposium Program is now under development, and successive drafts of the agenda will be circulated to all of you for comment and suggestions. However, I will be inviting the senior Chinese and American SHS investigators to make the major presentations and asking that some members of the ERP and SRP participate by chairing sessions and making introductory remarks. I look forward to your participation in what I anticipate will be a lively and interesting meeting. With best regards, Cc: [senior SHS administrative staff; Consortium Committees chairs] SH ELL-MCCLU RG-052958 From: Sent: To: Cc: Subject: Attach: Matt Todd <ToddM@api.org> on behalf of shanghaihealthstudy <info@shanghaihealthstudy.org> Wednesday, June 15,2005 8:41 PM (GMT) Tsai, Shan P SHLOIL-SHS <shan.tsai@shell.com> Matt Todd <ToddM@api.org> 2005 SHS Annual Meeting Invitation & Registration 2005 _ Annual_Meeting_Invitation_B H R C_ Tsai.pdf; 2005_SHS_Annual_Meeting_Regi stration. doc Shan, Please see the attached invitation and registration form to attend the 2005 SHS Annual Meeting. Please fill out this form and return to me via email or fax. Feel free to contact me with any questions you may have. Best Regards, Matt Todd Matthew Todd Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005 p: (202)682-8319 f: (202)682-8031 www.api.org SH ELL-MCCLU RG-052959 SHANGHAI HEALTH STUDY ANNUAL MEETING 1 - 3 NOVEMBER 2005 RESERVATION I REGISTRATION REQUEST Title: First Name: _____________________________________________________________________ Last Name: Name for Badge: Companyor~iliation: ___________________________________________________________ Address: ______________________________________________________________________ Phone: __________________________ Fax: Email: ACCOMMODATIONS: __ (I I We) plan to stay at the Ritz-Carlton in Tyson's Corner, Virginia. Important: Participants are responsible for contacting the hotel directly to reserve a room. Please inform the hotel that you are with the Shanghai Health Study. Hotel Information: Phone: (703) 506-4300 Website: Ritz Carlton Tyson's Corner Reservations I will arrive on: _________________ Depart on: ADDITIONAL GUESTS: Fi rst and Last Name(s): _________________________________________________________________________________ SPECIAL EVENTS: (Yes I No) (I I We) will attend the reception and dinner at Maggiano's on Tuesday evening, Nov. 1st): (# of adults __ # of children_ _) (Yes I No) (I I We) will attend the dinner at Peking Gourmet Inn on Wednesday evening, Nov. 2nd : (# of adults __ # of children_ _) I (have I do not have) special needs. Please let us know how we can assist. Please email completed registration form to toddm@api.org or fax to Matt Todd at 202-682-8031 ;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;; SH ELL-MCCLU RG-OS2960 SHANGHAI HEALTH STUDY June 15,2005 Shan Tsai Shell Oil Company POB 4365 Houston, TX Patsy Clegg Oversight Committee Chair 1220 L Street, NW Washington, DC 20005-4070 Tel: 202-682-8000 Fax: 202-682-8207 www.api.org Dear Shan Tsai, On behalf of the Benzene Health Research Consortium, I cordially request your participation in the 2005 Annual Shanghai Health Study Meeting. The meeting is organized to bring together all of the essential individuals that make this study successful which includes the principal investigators, independent review panel members, funding company representatives, and study administrators. Therefore, as a Technical Committee member, your presence is critical to the meeting's success. The annual meeting will take place in Fairfax, Virginia on November 1st to 3rd, 2005. A hotel room has been reserved for you at the Ritz Carlton in Tyson's Comer, Virginia (1700 Tysons Boulevard, McLean, Virginia, 22102). The hotel is located approximately ten minutes from the nearby Exxon Mobil Corporation's facility (3225 Gallows Road, Fairfax, VA 22037) where all the annual meetings will take place. Matt Todd, ofthe American Petroleum Institute, will follow up with you via e-mail to coordinate your arrival to attend this event. If you have any questions or need additional information, please contact Matt at toddm(2t;api.org or call 1-202-682-8319. Thank you for your important contribution to the Shanghai Health Study and for your attendance at the third annual meeting. Best regards, Patsy Clegg Oversight Committee Chair Shell Chemical LP ........ :.:'Y.>.:.: SHELL-MCCLURG-052961 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Thursday, March 4,20045:24 PM (GMT) benzconsort-tc@listserve.api.org Matt Todd <ToddM@api.org> BHRC-TC... DP & ME (Dr Irons') Dec 2003 Progress Report DP ME Progress + Expense Rpt 12-03.doc; DP ME Progress Expense Rpt 12-03.pdf Benzene Health Research Consortium (BHRC) Technical Committee (TC) - Attached is Richard Iron's progress and expense report from the Disease Progression (DP) and Molecular Epidemiology (ME) portions of the Shanghai Health Study, presenting activities from the second-half, July - December, of 2003. The report is attached in both Microsoft Word (doc) and Adobe Acrobat (pdf) formats. An abbreviated copy of this report, lacking only the front-end UCHSC expense information, was distributed to both the SRP & ERP expert panels. By copy to Matt Todd, would you please add this report to the SHS website for Consortium Committee access ... thanks! Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-OS2962 PROGRESS REPORT December 2003 1. ANALYSIS OF DISEASE PROGRESSION FOR APLASTIC ANEMIA, MYELODYSPLASTIC SYNDROME, ACUTE MYELOGENOUS LEUKEMIA AND BENZENE POISONING IN SHANGHAI, CHINA II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS IN SHANGHAI, CHINA Richard D. Irons A MULTICENTER INTERNATIONAL STUDY Molecular Toxicology and Environmental Health Sciences Program Dept. of Pharmaceutical Sciences, School of Pharmacy Department of Pathology, School of Medicine University of Colorado Health Sciences Center, Denver, CO. School of Public Health, Hua Shan Hospital, Cancer Hospital, Fudan University Medical Center, Shanghai, China SH ELL-MCCLU RG-OS2963 Overall Status of Budget Comparison of actual to budget projections cited in this report were derived from the updated budget projections provided to API in September 2002 (Appendix A). JCML initiated clinical laboratory functions in 3rd quarter, with the case referral rate increasing progressively for a total of 225 during the last 5 months of 2003. Consequently, we are undergoing a transition in the budgetary tracking process and are continually evaluating resource allocation based on study contingencies. During the second half of 2003 a total of $1,077,479 was expensed compared to a projected budget of $2,039,466. This resulted in $961,987 in funds budgeted but not expensed during this period (Table 1). These figures are subject to modification pending an update of subcontract agreements that reflect post SRP budgetary expenditures as well as laboratory and field contingencies that we are currently addressing and that are discussed in the Progress Section. Table 1. Budget Summary (Reporting Period) Report (6/03-12/03) Category Personnel Operating Expenses Subcontracts Travel Equipment Indirect TOTALS Budgeted Expend itu res $293,007 $230,328 $259,003 $162,834 $988,733 $565,870 $4,127 $0 $350,000 $17,000 $144,596 $101,447 $2,039,466 $1,077,479 Variance $62,679 $96,169 $422,863 $4,127 $333,000 $43,149 $961,987 The budgeted amounts are the sum of each category from Jun-03 through Dec-03. 2 SH ELL-MCCLU RG-OS2964 Table 2. Budget Summary (Entire Project) Totals from 9/01-12/03 Category Personnel Operating Expenses Subcontracts Travel Equipment Indirect TOTALS Budgeted Expenditures $1,369,623 $1,255,819 $848,969 $627,106 $3,456,406 $2,437,102 $39,414 $8,993 $1,560,213 $1,191,150 $613,082 $523,312 $7,887,707 $6,043,482 Variance $113,804 $221,863 $1,019,304 $30,421 $369,063 $89,770 $1,844,225 The budgeted amounts are the sum of each category from Sept-01 through Dec-03. PERSONNEL Savings in personnel are temporary and reflect some reshuffling of staff activities. The administrative costs of the project continue to increase in order to keep pace with administrative, accounting and regulatory requirements. In addition, we periodically have to make late phase changes in the database as well as provide continuing daily maintenance of the computer network, both at UCRSC and in Shanghai. Also, because of Chinese import restrictions, we are routinely required to negotiate and administer contracts and requisition of much of the supplies and reagents for JCML from UCRSC and then ship them to China. We are using this strategy approximately twice as much as we originally planned due to inefficiencies in Chinese purchasing/import practices. To date this has resulted in some cost shifting but no demonstrable budgetary excursions as reflected in the summary tables. JCML OPERATING EXPENSE/CASE-SPECIFIC COSTS Operating expenses are beginning to escalate to keep pace with JCML laboratory activities and case accrual. Weare monitoring these activities with a view toward evaluating their impact on the overall budget. We have made some headway in developing a mechanism to track subjectspecific diagnostic and case accrual costs and have made a tentative comparison between our original budgetary projections and JCML operating expenses and subject costs for the 4th quarter of 2003, which is the first quarter we have experienced full laboratory clinical operation. Our original 4th quarter estimated subject costs were $268,618 versus actuals of $262,700. In contrast, our 4th quarter estimated personnel and maintenance costs for Fudan were $81,363 versus actuals of $138,384. The latter includes charges for minor equipment as well as reorganization of the CC, DP and ME exposure assessment teams discussed below. 3 SH ELL-MCCLU RG-052965 SUBCONTRACTS We are currently extending the agreement with ExxonMobil Biomedical. All others have been renewed through 2004. We are anticipating a significant redistribution of workscope among Chinese subcontractors that will be reflected in the 2004 budget. EQUIPMENT Equipment funds were originally budgeted for December 2003 in order to deal with contingencies we anticipated developing after laboratory start up. These expenses were postponed due to the delay in startup. However, with late breaking changes described in the Progress Section we anticipate that the majority of these funds will be expensed in 2004 as originally planned. 4 SH ELL-MCCLU RG-OS2966 AppendixA. China Project Budget Projections provided API in September 2002. Dec-01 Jun-02 Dec-02 Jun-03 Dec-03 Jun-04 Dec-04 Jun-05 Dec-05 Jun-06 Dec-06 Totals (J) I m r r sI : () () r C ;a G) oI c..n I'V <D (J) -.....J PROGRESS REPORT JCML Laboratory Clinical Activities JCML began routine full service clinical operations around the beginning of August 2003. These activities include: routine hematology, bone marrow aspirate analysis, bone marrow and lymph node histopathology, clinical chemistry-liver enzymes, serology, flow cytometric analysis of blood, bone marrow and lymph node preparations, cytogenetics, FISH and molecular genetics. As of December 31 S\ after the first 5 months of operations, approximately 190 cases had been referred to JCML for diagnosis as part of the clinical operation. (The case contact rate has continued to increase with over 270 cases having been seen by the end of 6 months.) An external pathology review was conducted in October 2003. As of October 31, 106 cases have successfully undergone secondary pathology review. Preliminary estimates suggest approximately a 50% concordance between initial hospital case diagnosis (if any) and the JCML diagnosis, and in excess of a 90% concordance between the JCML diagnosis and secondary pathology review. The latter is an acceptable standard of concordance between US laboratories. Clinical Service Statistics An important measure of clinical laboratory service performance is the time from sample collection to the availability of test results (i.e. tum-around times (TAT. The TAT for routine hematology in support of the 23 referring hospitals is normally under 2 hours with no excursions in routine clinical cases beyond 4 hours as of 12/31/03. Routine analyses of bone marrow aspirates average 3-7 days. For acute cases, preliminary aspirate analyses are available within 1-3 days. Flow cytometric analysis of bone marrow or lymph node preparations are completed within 1-4 days. The TAT for cytogenetics analyses averages 6-10 days with 70-80% being completed within 7 days. FISH analyses are 90% completed within less than 7 days. For acute cases, cytogenetics are completed within 5 days and FISH analyses within 2-3 days. The AML abnormal frequency rate is 57.14% for cytogenetics and 60% combined for cytogenetics and FISH. For the lymphoma cases, the abnormal cytogenetics rate is close to 80%. These statistics exceed the performance of most US clinical laboratories. The TAT for bone marrow or lymph node histology is 5-7 days. At present, the TAT for bone marrow or lymph node histology is 5-7 days and case-specific availability of control slides is spotty. This is not an acceptable standard of performance, and efforts are underway to correct the situation. DNA and RNA are routinely isolated from samples received the same day, with all samples processed within 24 hours. Random RNA samples are subjected to electrophoresis, with visual confirmation of the 18S and 28S fractions demonstrating quality RNA. Additional quality control for DNA samples is provided by the amplification of the FLT-3 gene, performed on all samples from a given week on the first day of the following week. At present, routine molecular analyses performed in the laboratory include analysis of FLT-3 internal tandem duplication by PCR and FLT-3 6 SH ELL-MCCLU RG-OS2968 amino acid substitution at D835 using RFLP, BCRlABL confirmation by rtPCR, and TCR beta or gamma chain gene rearrangements by PCR and hetero/homoduplex analysis. Additional study mandated molecular analyses (M. HHV8, NQ01) are not time sensitive and will be processed as time allows. Initially, MNC from all blood and bone marrow samples coming into JCML were preserved in two aliquots each using 3-4 ml of starting material. This volume of starting material is sub optimal. However, randomly selected samples demonstrate greater than 90% viability upon thawing. Initial EBV viral lots harvested from cells obtained in Shanghai have failed to transform both patient samples and test samples. Therefore, EBV supernatant was prepared in Colorado and shipped to Shanghai. This material has been used to successfully immortalize test cultures. Efforts are underway to increase the transformation efficiency of the culturing process and increase the starting blood sample volume. Patient cultures are now in the process of being immortalized using MNC that have been cryopreserved for subsequent immortalization. Sample thawing viability for December was determined to be 99.4%. Case Control (CC) IDisease Progression (DP) Case Accrual By December 31 st approximately 190 cases were referred to JCML for diagnosis as part of the clinical operation, and, as of October 31, 106 cases have successfully undergone secondary pathology review. The case contact rate has not reached a steady state but continues to increase with over 270 cases accrued by the end of 6 months. Diagnoses qualifYing for inclusion in the CC or DP studies represented 83% of the total case contacts with 17% of cases being diagnosed as non-qualifying or excluded conditions. Individual disease diagnoses included: AML 42, NHL 66, AA 17, and MDS 26. Again, these numbers should be interpreted with caution because JCML has not yet reached a steady state with respect to rate of clinical case accrual. Whether this reflects a progressively increasing case accrual or fluctuating admissions is not understood at this time. Exposure Assessment A variety of problems associated with procedure de-bugging, coordination and implementation led to an initial lag in exposure assessment operations relative to JCML case accrual. Early on, these issues were magnified by the high case accrual rate. However, we have re-organized the exposure assessment teams, which have undergone additional training and are now operational. By mid-January over 460 subjects had been entered into the exposure assessment program. The first stage assignment (exposed, unexposed, uncertain) produced a rapid initial sorting. From that stage, 12 subjects were classified as "exposed" for benzene, and are undergoing a more thorough quantitative assessment. The "uncertain" category included 67 subjects for which further information is needed (M. review of IPHS database work site inspections). Many of these uncertain ratings are expected to be transferred into the "benzene exposed" category. An additional 35 "other exposures" (i.e. other workplace hazards of concern besides benzene) have 7 SH ELL-MCCLU RG-OS2969 been identified and classified and another 270 subjects were classified as having no exposure or "unexposed". Independently, the Exposure Assessment (EA) team has compiled the Chinese literature for information on benzene exposure. District IPHS written records (not in the central database) and specific factory records are also being located. A Fudan team member has also initiated quality assurance overviews for the IPHS database searching process. Control Selection for CC/DP We have periodically reviewed the demographic characteristics and diagnoses for controls in order to ensure that procedures outlined in the protocol are being implemented correctly in the field. These periodic audits have shown that the matching criteria are being followed (i.e. controls are being successfully matched according to age and gender). However, we have determined that, on occasion, the protocol is not uniformly applied in all hospitals. Specifically, the selection of a control subject with the closest time of admission to that of a study subject is not always adhered to. Therefore, we met with clinical coordinators and reemphasized the control selection procedure with regard to time of admission/diagnosis. Some hospitals do not have a central admissions log, making it impossible to ensure that the control with the closest time of diagnosis is identified. In lieu of this, we are currently reviewing the procedures in every hospital separately, to assess whether there is any systematic bias in selecting controls. Molecular Epidemiology (ME) Study Phase 1 activities. The longitudinal exposure analysis of workers is progressing well. We have been successful in identifying several factories from which benzene workers were examined by hospitals over the past several years, and have correlated these with benzene monitoring data in the IPHS database. Professor Ni has identified a subset of factories that historically may have experienced high concentrations of benzene exposure. These are being investigated on a factory-by-factory basis. To date, we have identified a small number of facilities that have both good monitoring data and good medical records. A review and abstraction of medical records for workers in these facilities is underway. In addition, we also have located the medical records for 194 individual cases of benzene poisoning that presented at local hospitals over approximately the past 5 years. Analysis of this data set has begun, and medical record retrieval and abstraction is underway for all of these activities. Phase 2a and 2b activites. We have recruited some workers to Phase 2a as part of a screening survey and an intensive two-week exposure analysis of a high exposure rubber products factory. Additional factory identification and recruitment activities are underway. Factory participation for Phase 2b has proven to be more difficult than initially envisioned. We originally anticipated recruiting subjects from adjacent or even distant provinces. Accordingly we are now simultaneously exploring suitable facilities, 8 SH ELL-MCCLU RG-052970 both in Shanghai and outside Shanghai. In addition, although originally we planned to rely heavily on IPHS staff to introduce the project to Factory Management we are currently evaluating several sites outside Shanghai, based on initial contact by Professor Ni, President of the Chinese Academy of Occupational Medicine. Benzene and Metabolite Analyses At UCHSC we set out to develop a minimal step method for the extraction and quantitation of the benzene metabolites from blood and bone marrow: phenol (PH), catechol (CAT), hydroquinone (HQ) and trans,trans-muconic acid (MA). The rationale for this approach was to design the simplest procedures possible for extraction and analysis of these compounds that facilitate implementation in Shanghai, utilizing existing instrumentation (GC/MS). Our reasoning proved to be prescient. The final method was based on liquid phase extraction with ascorbic acid, acetonitrile and toluene. Deuterated derivatives for each metabolite were purchased or synthesized and employed as internal standards. The limit of detection for PH, CAT and HQ in blood samples was in the nanogram range. There is no commercial source for deuterated trans,trans-muconic acid[1,2,5 ,6-13C]. Therefore synthesis was achieved by refluxing a solution of triphenylphosphine and ethyl[I,2-13C2]bromoacetate in a mixture of acetonitrile and dichloromethane (ml) that was washed, dehydrated over magnesium sulfate and dissolved in dimethylformamide (DMF) to which glyoxal trimeric dehydrate was added to give the muconic acid diethyl ester. This was then dissolved in THF and lithium hydroxide in water. The solvents were evaporated under reduced pressure and the residue was suspended in a mixture of toluene and hydrochloric acid (PH 2.0). Publication of the method and analysis of background levels of benzene metabolites in the blood and bone marrow of unexposed volunteers awaits measurements that are still forthcoming from SMCDCP and that have been frustrated by events at SMCDCP discussed below. Following on the recommendation of the SRP at the annual meeting in August, we investigated the possibility of measuring sPMA in urine of ME Phase 2b subjects. A direct, linear relationship exists between the internal dose of benzene and the rate of excretion of sPMA. Urinary sPMA is therefore an useful biomarker of exposure to benzene. The measurement can be easily performed using a small volume of urine, collected at an appropriate time relative to potential exposure. The strategy we have adopted for analysis of urinary sPMA is an enzyme-linked immunoabsorbant assay (ELISA). Therefore, we have negotiated a site license to employ ELISA assay owned by AB Biomonitoring, Ltd, Cardiff, UK. This methodology will be implemented following approval of the addition of urinary collection to our Phase 2b clinical protocol. ***Recent Development as/ofFebruary 19, 2004*** Despite two years time, the SMCDC has failed to successfully adapt these analytical methods for analysis of blood and bone marrow, and, for that matter, has not provided entirely satisfactory results for the measurement of benzene in air or any results for 9 SHELL-MCCLURG-052971 exhaled breath analysis. The stated reasons are many, including serious illness in senior technical personnel resulting in a chronic lack of leadership, instrumentation problems that remain unresolved, and the inability or lack of resolve to commit adequate personnel and time to the project. We recently completed a detailed analysis of CDC analytical capability that included inspection and review of methods and procedures by Professor Zheng Xixing of Fudan University and David Chang of ExxonMobil. We have concluded that CDC has provided less than desired performance for analytical support for benzene or benzene metabolites. Among the issues that remain unresolved are: 1) in all cases, standard curves remain inadequate and are extrapolated from high values; 2) split sample analysis reveals an unacceptable and consistently low bias in contrast to paired samples analyzed by an AIHA certified laboratory; 3) despite several deadlines and adequate guidance they have not developed a satisfactory method of analysis for benzene in exhaled breath or benzene metabolites in blood and bone marrow. These issues have been the subject of frequent discussion with SMCDC staff and management as they have unfolded over the last year. Therefore, after protracted negotiations and little sign of success, we have terminated our agreement with SMCDC to conduct analyses as part of the project. We are collaborating with Fudan University to transfer all analytical activities to JCML with a minimum of delay. Because this is a very recent development we have not had an opportunity to evaluate every impact that this contingency will have on the project. Quality Assessment Issues Elements of QAlQC have been referred to throughout this report as they specifically refer to other areas, such as Exposure Assessment, Control Selection, JCML clinical laboratory operations and benzene metabolism. In order to improve overall coordination, professor Liang Youxin has been assigned the task of supervising QAlQC for exposure assessment, and the data entry process has been streamlined. Gail Joregenson from Exxonmobil visited JCML in early 2004 to consult with and evaluate the overall process and to coordinate late phase database changes which will be reported in the next progress report. Conclusions During the last 6 months we have successfully begun JCML clinical and research operations and are routinely diagnosing blood and lymphoid diseases for the 23 participating hospitals in Shanghai. Operating a combined clinical and research laboratory of this magnitude in the local Shanghai environment creates a number of unique challenges. In most areas of clinical operation, based on objective criteria, we meet or exceed the standards of many of our US counterparts. We have successfully undergone our first external pathology diagnostic review, which was a milestone. We are preparing for the second review which will be conducted in April 2004. In the research arena all processes are up to speed except immortalization of cell lines. For EBV immortalization, the problems have been identified and largely resolved as of February, 2004. In some clinical areas we need to provide additional support, training for and coordination with our clinicians and laboratory colleagues in Shanghai in order to 10 SH ELL-MCCLU RG-OS2972 improve local standards of practice to meet CAP operational criteria. These relatively small details will continue to be addressed, but for the moment we are on track and functional. I believe we are on the way to becoming both a US and Chinese referral laboratory. The caseload number and variety of diseases encountered is remarkable. We are accruing an acceptable or greater than predicted number of study cases based on our initial projections, and the rate continues to grow. Control selection for CC/DP has required additional training and orientation of clinical coordinators and the recognition that the 23 participating hospitals have markedly different capabilities and standards when it comes to tracking patient admissions. We are developing individualized approaches to deal with these issues and standardize as much as possible the control selection process. Exposure assessment under the leadership of the Fudan team got off to a predictably slower start than JCML. Progress on EA improved after we reorganized the exposure assessment operation and conducted an intensive training initiative to streamline the process. This effort has been a collaborative one, requiring the expertise and attention of all the major US collaborators on this project as well as our colleagues at Fudan University. The EA operation is improving with a renewed understanding of the need for ongoing training and continued guidance by US personnel. Although we have had very good experiences interacting with and recruiting factory workers, we have experienced some challenges in encouraging factory management participation in the ME study. We have taken a multifaceted approach to dealing with this process including: attempting to fine tune the approach of IPHS to initiating factory involvement, exploring political solutions, actively pursuing leads outside of town. It has come as somewhat of a surprise that our biggest challenge has turned out to be obtaining high quality analytical support. However, in the absence of any demonstrable improvement in SMCDCP analytical capabilities over the past year, the need for a change in tactics has become imminent. Our immediate focus is on achieving a rapid and efficient transition to bring the analytical capabilities necessary for the project on line at JCML. To this end we are experiencing active cooperation and support from Fudan University. The goal is to have this implemented before the next 6 month reporting period. Analytical support for benzene air monitoring should be implemented faster than that. 11 SH ELL-MCCLU RG-052973 PROGRESS REPORT December 2003 1. ANALYSIS OF DISEASE PROGRESSION FOR APLASTIC ANEMIA, MYELODYSPLASTIC SYNDROME, ACUTE MYELOGENOUS LEUKEMIA AND BENZENE POISONING IN SHANGHAI, CHINA II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS IN SHANGHAI, CHINA Richard D. Irons A MULTICENTER INTERNATIONAL STUDY Molecular Toxicology and Environmental Health Sciences Program Dept. of Pharmaceutical Sciences, School of Pharmacy Department of Pathology, School of Medicine University of Colorado Health Sciences Center, Denver, CO. School of Public Health, Hua Shan Hospital, Cancer Hospital, Fudan University Medical Center, Shanghai, China SH ELL-MCCLU RG-OS2974 Overall Status of Budget Comparison of actual to budget projections cited in this report were derived from the updated budget projections provided to API in September 2002 (Appendix A). JCML initiated clinical laboratory functions in 3rd quarter, with the case referral rate increasing progressively for a total of 225 during the last 5 months of 2003. Consequently, we are undergoing a transition in the budgetary tracking process and are continually evaluating resource allocation based on study contingencies. During the second half of2003 a total of $1,077,479 was expensed compared to a projected budget of $2,039,466. This resulted in $961,987 in funds budgeted but not expensed during this period (Table 1). These figures are subject to modification pending an update of subcontract agreements that reflect post SRP budgetary expenditures as well as laboratory and field contingencies that we are currently addressing and that are discussed in the Progress Section. Table 1. Budget Summary (Reporting Period) Report (6/03-12/03) Category Personnel Operating Expenses Subcontracts Travel Equipment Indirect TOTALS Budgeted Expenditures $293,007 $230,328 $259,003 $162,834 $988,733 $565,870 $4,127 $0 $350,000 $17,000 $144,596 $101,447 $2,039,466 $1,077,479 Variance $62,679 $96,169 $422,863 $4,127 $333,000 $43,149 $961,987 The budgeted amounts are the sum of each category from Jun-03 through Dec-03. 2 SH ELL-MCCLU RG-052975 Table 2. Budget Summary (Entire Project) Totals from 9/01-12/03 Category Personnel Operating Expenses Subcontracts Travel Equipment Indirect TOTALS Budgeted Expenditures $1,369,623 $1,255,819 $848,969 $627,106 $3,456,406 $2,437,102 $39,414 $8,993 $1,560,213 $1,191,150 $613,082 $523,312 $7,887,707 $6,043,482 Variance $113,804 $221,863 $1,019,304 $30,421 $369,063 $89,770 $1,844,225 The budgeted amounts are the sum of each category from Sept-O 1 through Dec-03. PERSONNEL Savings in personnel are temporary and reflect some reshuffling of staff activities. The administrative costs of the project continue to increase in order to keep pace with administrative, accounting and regulatory requirements. In addition, we periodically have to make late phase changes in the database as well as provide continuing daily maintenance of the computer network, both at UCRSC and in Shanghai. Also, because of Chinese import restrictions, we are routinely required to negotiate and administer contracts and requisition of much of the supplies and reagents for JCML from UCRSC and then ship them to China. We are using this strategy approximately twice as much as we originally planned due to inefficiencies in Chinese purchasinglimport practices. To date this has resulted in some cost shifting but no demonstrable budgetary excursions as reflected in the summary tables. JCML OPERATING EXPENSE/CASE-SPECIFIC COSTS Operating expenses are beginning to escalate to keep pace with JCML laboratory activities and case accrual. We are monitoring these activities with a view toward evaluating their impact on the overall budget. We have made some headway in developing a mechanism to track subjectspecific diagnostic and case accrual costs and have made a tentative comparison between our original budgetary projections and JCML operating expenses and subject costs for the 4th quarter of 2003, which is the first quarter we have experienced full laboratory clinical operation. Our original 4th quarter estimated subject costs were $268,618 versus actuals of $262,700. In contrast, our 4th quarter estimated personnel and maintenance costs for Fudan were $81,363 versus actuals of $138,384. The latter includes charges for minor equipment as well as reorganization of the CC, DP and ME exposure assessment teams discussed below. 3 SH ELL-MCCLU RG-052976 SUBCONTRACTS We are currently extending the agreement with ExxonMobil Biomedical. All others have been renewed through 2004. We are anticipating a significant redistribution of workscope among Chinese subcontractors that will be reflected in the 2004 budget. EQUIPMENT Equipment funds were originally budgeted for December 2003 in order to deal with contingencies we anticipated developing after laboratory start up. These expenses were postponed due to the delay in startup. However, with late breaking changes described in the Progress Section we anticipate that the majority of these funds will be expensed in 2004 as originally planned. 4 SH ELL-MCCLU RG-OS2977 AppendixA. China Project Budget Projections provided API in September 2002. Dec-01 Jun-02 Dec-02 Jun-03 Dec-03 Jun-04 Dec-04 Jun-05 Dec-05 Jun-06 .Budgeted $172,140 ........ $224,883 qp~"~tiOgg~~O$~> Budgeted I $13,131 $94,401 Subcontracts> . .............................. Budgeted $123,629 $688,452 Travel> Budgeted eql.iipili~ilt Budgeted Indirect>. $0 $8,429 .......................... $291,568 Bud eted Budgeted $648,390 $1,381,197 $2,587,943 $1,230,71 1 $2,039,465 $1,097,683 $1,652,637 $1,142,048 $1,634,027 $1,143,094 Dec-06 $700,822 Totals $15,258,017 SH ELL-MCCLU RG-052978 PROGRESS REPORT JCML Laboratory Clinical Activities JCML began routine full service clinical operations around the beginning of August 2003. These activities include: routine hematology, bone marrow aspirate analysis, bone marrow and lymph node histopathology, clinical chemistry-liver enzymes, serology, flow cytometric analysis of blood, bone marrow and lymph node preparations, cytogenetics, FISH and molecular genetics. As of December 31 S\ after the first 5 months of operations, approximately 190 cases had been referred to JCML for diagnosis as part of the clinical operation. (The case contact rate has continued to increase with over 270 cases having been seen by the end of 6 months.) An external pathology review was conducted in October 2003. As of October 31, 106 cases have successfully undergone secondary pathology review. Preliminary estimates suggest approximately a 50% concordance between initial hospital case diagnosis (if any) and the JCML diagnosis, and in excess of a 90% concordance between the JCML diagnosis and secondary pathology review. The latter is an acceptable standard of concordance between US laboratories. Clinical Service Statistics An important measure of clinical laboratory service performance is the time from sample collection to the availability of test results (i.e. turn-around times (TAT)). The TAT for routine hematology in support of the 23 referring hospitals is normally under 2 hours with no excursions in routine clinical cases beyond 4 hours as of 12/31/03. Routine analyses of bone marrow aspirates average 3-7 days. For acute cases, preliminary aspirate analyses are available within 1-3 days. Flow cytometric analysis of bone marrow or lymph node preparations are completed within 1-4 days. The TAT for cytogenetics analyses averages 6-10 days with 70-80% being completed within 7 days. FISH analyses are 90% completed within less than 7 days. For acute cases, cytogenetics are completed within 5 days and FISH analyses within 2-3 days. The AML abnormal frequency rate is 57.14% for cytogenetics and 60% combined for cytogenetics and FISH. For the lymphoma cases, the abnormal cytogenetics rate is close to 80%. These statistics exceed the performance of most US clinical laboratories. The TAT for bone marrow or lymph node histology is 5-7 days. At present, the TAT for bone marrow or lymph node histology is 5-7 days and case-specific availability of control slides is spotty. This is not an acceptable standard of performance, and efforts are underway to correct the situation. DNA and RNA are routinely isolated from samples received the same day, with all samples processed within 24 hours. Random RNA samples are subjected to electrophoresis, with visual confirmation of the 18S and 28S fractions demonstrating quality RNA. Additional quality control for DNA samples is provided by the amplification of the FLT-3 gene, performed on all samples from a given week on the first day of the following week. At present, routine molecular analyses performed in the laboratory include analysis of FLT-3 internal tandem duplication by PCR and FLT-3 6 SH ELL-MCCLU RG-052979 amino acid substitution at D835 using RFLP, BCRlABL confirmation by rtPCR, and TCR beta or gamma chain gene rearrangements by PCR and hetero/homoduplex analysis. Additional study mandated molecular analyses (M. HHV8, NQ01) are not time sensitive and will be processed as time allows. Initially, MNC from all blood and bone marrow samples coming into JCML were preserved in two aliquots each using 3-4 ml of starting material. This volume of starting material is sub optimal. However, randomly selected samples demonstrate greater than 90% viability upon thawing. Initial EBV viral lots harvested from cells obtained in Shanghai have failed to transform both patient samples and test samples. Therefore, EBV supernatant was prepared in Colorado and shipped to Shanghai. This material has been used to successfully immortalize test cultures. Efforts are underway to increase the transformation efficiency of the culturing process and increase the starting blood sample volume. Patient cultures are now in the process of being immortalized using MNC that have been cryopreserved for subsequent immortalization. Sample thawing viability for December was determined to be 99.4%. Case Control (CC) !Disease Progression (DP) Case Accrual By December 31 8t approximately 190 cases were referred to JCML for diagnosis as part of the clinical operation, and, as of October 31, 106 cases have successfully undergone secondary pathology review. The case contact rate has not reached a steady state but continues to increase with over 270 cases accrued by the end of 6 months. Diagnoses qualifying for inclusion in the CC or DP studies represented 83% of the total case contacts with 17% of cases being diagnosed as non-qualifying or excluded conditions. Individual disease diagnoses included: AML 42, NHL 66, AA 17, and MDS 26. Again, these numbers should be interpreted with caution because JCML has not yet reached a steady state with respect to rate of clinical case accrual. Whether this reflects a progressively increasing case accrual or fluctuating admissions is not understood at this time. Exposure Assessment A variety of problems associated with procedure de-bugging, coordination and implementation led to an initial lag in exposure assessment operations relative to JCML case accrual. Early on, these issues were magnified by the high case accrual rate. However, we have re-organized the exposure assessment teams, which have undergone additional training and are now operational. By mid-January over 460 subjects had been entered into the exposure assessment program. The first stage assignment (exposed, unexposed, uncertain) produced a rapid initial sorting. From that stage, 12 subjects were classified as "exposed" for benzene, and are undergoing a more thorough quantitative assessment. The "uncertain" category included 67 subjects for which further information is needed (M. review ofIPHS database work site inspections). Many of these uncertain ratings are expected to be transferred into the "benzene exposed" category. An additional 35 "other exposures" (i.e. other workplace hazards of concern besides benzene) have 7 SH ELL-MCCLU RG-OS2980 been identified and classified and another 270 subjects were classified as having no exposure or "unexposed". Independently, the Exposure Assessment (EA) team has compiled the Chinese literature for information on benzene exposure. District IPHS written records (not in the central database) and specific factory records are also being located. A Fudan team member has also initiated quality assurance overviews for the IPHS database searching process. Control Selection for CCIDP We have periodically reviewed the demographic characteristics and diagnoses for controls in order to ensure that procedures outlined in the protocol are being implemented correctly in the field. These periodic audits have shown that the matching criteria are being followed (i.e. controls are being successfully matched according to age and gender). However, we have determined that, on occasion, the protocol is not uniformly applied in all hospitals. Specifically, the selection of a control subject with the closest time of admission to that of a study subject is not always adhered to. Therefore, we met with clinical coordinators and reemphasized the control selection procedure with regard to time of admission/diagnosis. Some hospitals do not have a central admissions log, making it impossible to ensure that the control with the closest time of diagnosis is identified. In lieu of this, we are currently reviewing the procedures in every hospital separately, to assess whether there is any systematic bias in selecting controls. Molecular Epidemiology (ME) Study Phase 1 activities. The longitudinal exposure analysis of workers is progressing well. We have been successful in identifying several factories from which benzene workers were examined by hospitals over the past several years, and have correlated these with benzene monitoring data in the IPHS database. Professor Ni has identified a subset of factories that historically may have experienced high concentrations of benzene exposure. These are being investigated on a factory-by-factory basis. To date, we have identified a small number of facilities that have both good monitoring data and good medical records. A review and abstraction of medical records for workers in these facilities is underway. In addition, we also have located the medical records for 194 individual cases of benzene poisoning that presented at local hospitals over approximately the past 5 years. Analysis of this data set has begun, and medical record retrieval and abstraction is underway for all of these activities. Phase 2a and 2b activites. We have recruited some workers to Phase 2a as part of a screening survey and an intensive two-week exposure analysis of a high exposure rubber products factory. Additional factory identification and recruitment activities are underway. Factory participation for Phase 2b has proven to be more difficult than initially envisioned. We originally anticipated recruiting subjects from adjacent or even distant provinces. Accordingly we are now simultaneously exploring suitable facilities, 8 SH ELL-MCCLU RG-OS2981 both in Shanghai and outside Shanghai. In addition, although originally we planned to rely heavily on IPHS staff to introduce the project to Factory Management we are currently evaluating several sites outside Shanghai, based on initial contact by Professor Ni, President of the Chinese Academy of Occupational Medicine. Benzene and Metabolite Analyses At UCHSC we set out to develop a minimal step method for the extraction and quantitation of the benzene metabolites from blood and bone marrow: phenol (PH), catechol (CAT), hydroquinone (HQ) and trans,trans-muconic acid (MA). The rationale for this approach was to design the simplest procedures possible for extraction and analysis of these compounds that facilitate implementation in Shanghai, utilizing existing instrumentation (GC/MS). Our reasoning proved to be prescient. The final method was based on liquid phase extraction with ascorbic acid, acetonitrile and toluene. Deuterated derivatives for each metabolite were purchased or synthesized and employed as internal standards. The limit of detection for PH, CAT and HQ in blood samples was in the nanogram range. There is no commercial source for deuterated trans,trans-muconic acid[1,2,5,6-13C]. Therefore synthesis was achieved by refluxing a solution of triphenylphosphine and ethyl[1,2-13C2]bromoacetate in a mixture of acetonitrile and dichloromethane (ml) that was washed, dehydrated over magnesium sulfate and dissolved in dimethylformamide (DMF) to which glyoxal trimeric dehydrate was added to give the muconic acid diethyl ester. This was then dissolved in THF and lithium hydroxide in water. The solvents were evaporated under reduced pressure and the residue was suspended in a mixture of toluene and hydrochloric acid (pH 2.0). Publication of the method and analysis of background levels of benzene metabolites in the blood and bone marrow of unexposed volunteers awaits measurements that are still forthcoming from SMCDCP and that have been frustrated by events at SMCDCP discussed below. Following on the recommendation of the SRP at the annual meeting in August, we investigated the possibility of measuring sPMA in urine of ME Phase 2b subjects. A direct, linear relationship exists between the internal dose of benzene and the rate of excretion of sPMA. Urinary sPMA is therefore an useful biomarker of exposure to benzene. The measurement can be easily performed using a small volume of urine, collected at an appropriate time relative to potential exposure. The strategy we have adopted for analysis of urinary sPMA is an enzyme-linked immunoabsorbant assay (ELISA). Therefore, we have negotiated a site license to employ ELISA assay owned by AB Biomonitoring, Ltd, Cardiff, UK. This methodology will be implemented following approval of the addition of urinary collection to our Phase 2b clinical protocol. ***Recent Development as/of February 19,2004*** Despite two years time, the SMCDC has failed to successfully adapt these analytical methods for analysis of blood and bone marrow, and, for that matter, has not provided entirely satisfactory results for the measurement of benzene in air or any results for 9 SH ELL-MCCLU RG-OS2982 exhaled breath analysis. The stated reasons are many, including serious illness in senior technical personnel resulting in a chronic lack of leadership, instrumentation problems that remain unresolved, and the inability or lack of resolve to commit adequate personnel and time to the project. We recently completed a detailed analysis of CDC analytical capability that included inspection and review of methods and procedures by Professor Zheng Xixing of Fudan University and David Chang ofExxonMobil. We have concluded that CDC has provided less than desired performance for analytical support for benzene or benzene metabolites. Among the issues that remain unresolved are: 1) in all cases, standard curves remain inadequate and are extrapolated from high values; 2) split sample analysis reveals an unacceptable and consistently low bias in contrast to paired samples analyzed by an AIHA certified laboratory; 3) despite several deadlines and adequate guidance they have not developed a satisfactory method of analysis for benzene in exhaled breath or benzene metabolites in blood and bone marrow. These issues have been the subject of frequent discussion with SMCDC staff and management as they have unfolded over the last year. Therefore, after protracted negotiations and little sign of success, we have terminated our agreement with SMCDC to conduct analyses as part of the project. We are collaborating with Fudan University to transfer all analytical activities to JCML with a minimum of delay. Because this is a very recent development we have not had an opportunity to evaluate every impact that this contingency will have on the project. Quality Assessment Issues Elements ofQAlQC have been referred to throughout this report as they specifically refer to other areas, such as Exposure Assessment, Control Selection, JCML clinical laboratory operations and benzene metabolism. In order to improve overall coordination, professor Liang Youxin has been assigned the task of supervising QAlQC for exposure assessment, and the data entry process has been streamlined. Gail Joregenson from Exxonmobil visited JCML in early 2004 to consult with and evaluate the overall process and to coordinate late phase database changes which will be reported in the next progress report. Conclusions During the last 6 months we have successfully begun JCML clinical and research operations and are routinely diagnosing blood and lymphoid diseases for the 23 participating hospitals in Shanghai. Operating a combined clinical and research laboratory of this magnitude in the local Shanghai environment creates a number of unique challenges. In most areas of clinical operation, based on objective criteria, we meet or exceed the standards of many of our US counterparts. We have successfully undergone our first external pathology diagnostic review, which was a milestone. We are preparing for the second review which will be conducted in April 2004. In the research arena all processes are up to speed except immortalization of cell lines. For EBV immortalization, the problems have been identified and largely resolved as of February, 2004. In some clinical areas we need to provide additional support, training for and coordination with our clinicians and laboratory colleagues in Shanghai in order to 10 SH ELL-MCCLU RG-OS2983 improve local standards of practice to meet CAP operational criteria. These relatively small details will continue to be addressed, but for the moment we are on track and functional. I believe we are on the way to becoming both a US and Chinese referral laboratory. The caseload number and variety of diseases encountered is remarkable. We are accruing an acceptable or greater than predicted number of study cases based on our initial projections, and the rate continues to grow. Control selection for CCIDP has required additional training and orientation of clinical coordinators and the recognition that the 23 participating hospitals have markedly different capabilities and standards when it comes to tracking patient admissions. Weare developing individualized approaches to deal with these issues and standardize as much as possible the control selection process. Exposure assessment under the leadership of the Fudan team got off to a predictably slower start than JCML. Progress on EA improved after we reorganized the exposure assessment operation and conducted an intensive training initiative to streamline the process. This effort has been a collaborative one, requiring the expertise and attention of all the major US collaborators on this project as well as our colleagues at Fudan University. The EA operation is improving with a renewed understanding of the need for ongoing training and continued guidance by US personnel. Although we have had very good experiences interacting with and recruiting factory workers, we have experienced some challenges in encouraging factory management participation in the ME study. We have taken a multifaceted approach to dealing with this process including: attempting to fine tune the approach of IPHS to initiating factory involvement, exploring political solutions, actively pursuing leads outside of town. It has come as somewhat of a surprise that our biggest challenge has turned out to be obtaining high quality analytical support. However, in the absence of any demonstrable improvement in SMCDCP analytical capabilities over the past year, the need for a change in tactics has become imminent. Our immediate focus is on achieving a rapid and efficient transition to bring the analytical capabilities necessary for the project on line at JCML. To this end we are experiencing active cooperation and support from Fudan University. The goal is to have this implemented before the next 6 month reporting period. Analytical support for benzene air monitoring should be implemented faster than that. 11 SH ELL-MCCLU RG-OS2984 From: Sent: To: Cc: Subject: Bruce Jarnot <jarnotb@api.org> Friday, February 27,20048:29 PM (GMT) benzconsort-oc@listserve.api.org benzconsort-cc@listserve.api.org; benzconsort-tc@listserve.api.org BHRC-OC... Outreach Organizations To: BHRC Oversight Committee (-OC), with copy to Communications Committee (-CC) From: BHRC Technical Committee (-TC) Subject: Outreach Organizations The BHRC-TC has compiled a list of regulatory, research and non-governmental organizations for Consortium Outreach communication regarding the Shanghai Health Studies. Renewed attention to Outreach generated a variety of feedback from (and cross-talk among) Consortium members regarding possible direct and indirect approaches, and as a result, several options have been proposed for consideration: Options for Direct Approach: -- host a one-day overview session at API, during Spring of 2004 -- host a one-day overview session at Asilomar, directly preceding the annual meeting -- invite interested organization members to attend the annual Asilomar conference -- site visits to organizations by Consortium member(s), using adaptable presentation Options for Indirect Approach: -- provide guidance to (updated) content posted on UCHSC web site -- by technical presentations (e.g., Oct 2004 Munich Benzene Symposium), abstracts and publications REGULATORY I STANDARD SETTING ORGANIZATIONS US EPA - DC (Bill Farland, Peter Preuss, Bob Sonowane, Michael Brown) IARC (Vincent Cogliano) EU Environment DG EU Labor DG Cal EPA German MAK Health Canada (Betty Meeks) OSHA ACGIH (Jim Price) Australia (info@nohsc.gov.au or info@nicnas.gov.au) RESEARCH ORGANIZATIONS NCI (Martha Linet) UK MRC (Michael Brown) US EPA - RTP (George Woodall, Larry Cupitt) NIEHS (Mike Shelby) NIOSH - Cincinnati NON-GOVERNMENTAL (NGO) ORGANIZATIONS Leukemia & Lymphoma Society American Cancer Society SH ELL-MCCLU RG-052985 For the BHRC-TC, with best regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-OS2986 From: Sent: To: Cc: Subject: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Monday, November 14, 2005 8:49 PM (GMT) Jerry Rice (E-mail)<Jmricewas@ao1.com> Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Michael Johnston <Mike. dJohnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Jennifer Galvin (E-mail)<jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail) <russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SCC-DCSI261 <sc724012@shell.com>; Colletti, Sarah J SCC-DCSI14 <sarah.colletti@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com> Shanghai Health Study Annual Meeting - Thanks! Jerry and Distinguished SRP Members; On behalf of the Benzene Health Research Consortium, I wish to express our thanks for your participation in the 3rd annual meeting of the Shanghai Health Study and the symposium on Friday. Your knowledge, expertise, and input are highly valued. We look forward to working with you to bring this study to a successful conclusion. ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SH ELL-MCCLU RG-052987 From: Sent: To: Subject: Attach: brian. e. doll@exxonmobil.com Thursday, October 27,2005 8:55 PM (GMT) Burnett, Don (E-mail)<burnetdm@bp.com>; Cagen, Stuart Z SCC-DCSI261 <stuart.cagen@shell.com>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Michael Johnston <Mike.dJohnston@conocophillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Twerdok, Lorraine (E-mail) <twerdokl@api.org>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Matthew A Hughes (E-mail) <hughm7@bp.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail)<russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Colletti, Sarah J SCC-DCSI14 <sarah.colletti@shell.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail)<vcrissey@chevrontexaco.com>; stephen.m.bowes@exxonmobil.com; mona.y.kowalczyk@exxonmobil.com Fw: Benzene Health Research Consortium - Meeting Tuesday, Nov 1, 3 PM 2005_SHS_Annual_Meeting_Information. doc As discussed below, a meeting has been scheduled for Tuesday, November 1, 3:00-5:00 PM, at the ExxonMobil Building at 3225 Gallows Road, Fairfax, Virginia, in Room C-17. The directions to the Building were communicated as part of the Annual Meeting materials sent out by Matt this afternoon and attached below for easy reference. Please let Lynn Russo know if you will be attending so we can arrange building passes with our Security folks. Please park in one of the Visitor Parking lots and enter the building by the "Big Red 0" sculpture (you can't miss it). Proceed to the main lobby on the second floor and obtain a badge at the reception desk. You will need to be escorted to the meeting room, so Lynn or I will likely meet you in the lobby if you are on time. If you are ruunning late, Mona Kowalczyck can escort you (extension 1018, or cell phone 1-703-282-5650). Room C-17 is the same room in which the plenary sessions will be held on November 2 and 3. The following are proposed agenda items for th is meeting: -- Welcome - Patsy -- Antitrust - Lorraine -- Review Agenda and final logistics for the Annual Meeting -- Prepare for November 3 meeting with PI's -- Finalize Agenda -- Review Time Line exercise (including next Annual Meeting and possible Symposium) --AOB If you have any problems getting into the building, feel free to call me on my cell phone below. Regards, Brian Doll Cell Phone: 1-703-944-8568 Office Phone: 1-703-846-2515 SH ELL-MCCLU RG-052988 (See attached file: 2005_SHS_AnnuaLMeeting_lnformation.doc) ----- Forwarded by Brian E Doli/Fairfax/Mobil-Notes on 10/27/0502:58 PM Lynn B Russo/Fairfax/ ExxonMobil To "Clegg, Patsy M SCC-DCS/22" <patsy.clegg@shell.com> 10/27/05 10:52 cc AM "Brian Doll \(E-mail\)" <brian .e.doll@exxonmobiLcom>, "Burnett, Don \(E-mail\)" <burnetdm@bp.com>, "Richard Herold \(E-mail\).. <heroldra@bp.com> , "Matthew A Hughes \(E-mail\)" <hughm7@BP.com>, "Bruce M. Jarnot \(E-mail\)" <jarnotb@api.org>, "Jennifer Galvin \(E-mail\)" <jennifer.b.galvin@conocophillips.co m>, "Michael Bird \(E-mail\)" <michael.g.bird@exxonmobil.com>, "Michael Johnston" <Mike.d.Johnston@ConocoPhillips.com> , "Myron Harrison \(E-mail\)" <myron .c. harrison@exxonmobil.com>, "Russell White \(E-mail\)" <russellwhite@chevrontexaco.com>, "Colletti, Sarah J SCC-DCS/14" <sarah .colietti@sheILcom>, "Shan Tsai \(E-mail\)" <Shan.Tsai@sheILcom>, "Stephen Bowes \(E-mail\)" <stephen.m.bowes@exxonmobil.com>, "Cagen, Stuart Z SCC-DCS/261" <stuart.cagen@sheILcom>, "Matthew Todd \(E-mail\)" <toddm@api.org>, "Twerdok, Lorraine \(E-mail\)" <twerdokl@api.org>, "Valerie Crissey \(E-mail\)" <vcrissey@chevrontexaco.com>, "Zach Wong \(E-mail\)" <ZachWong@chevrontexaco.com> Subject Re: Benzene Health Research Consortium - Meeting Tuesday, Nov 1, 3 PM(Document link: Brian E Doll) Would folks please let me know if you plan to attend this short pre-meeting so we can have building passes available for you. Thanks. Lynn SH ELL-MCCLU RG-052989 ..Clegg. Patsy M SCC-DCS/22" <patsy.clegg@s To helLcom> "Brian Doll \(E-mail\)" <brian .e.doll@exxonmobiLcom>, "Burnett, Don \(E-mail\)" 10/26/0506:06 <burnetdm@bp.com>, "Cagen, Stuart Z PM SCC-DCS/261 " <stuart.cagen@sheILcom>, "Jennifer Galvin \(E-mail\)" <jennifer.b.galvin@conocophillips.co m>, "Lynn Russo \(E-mail\)" <lynn.b.russo@exxonmobiLcom>, "Michael Johnston" <Mike.d.Johnston@ConocoPhillips.com> , "Zach Wong \(E-mail\)" <ZachWong@chevrontexaco.com>, "Twerdok, Lorraine \(E-mail\)" <twerdokl@api.org>, "Bruce M. Jarnot \(E-mail\)" <jarnotb@api.org>, "Matthew A Hughes \(E-mail\)" <hughm7@BP.com>, "Michael Bird \(E-mail\)" <michael.g.bird@exxonmobil.com>, "Russell White \(E-mail\)" <russellwhite@chevrontexaco.com>, "Shan Tsai \(E-mail\)" <Shan.Tsai@sheILcom>, "Stephen Bowes \(E-mail\)" <stephen.m.bowes@exxonmobil.com>, "Colletti, Sarah J SCC-DCS/14" <sarah .colietti@sheILcom>, "Matthew Todd \(E-mail\)" <toddm@api.org>, "Myron Harrison \(E-mail\)" <myron .c. harrison@exxonmobil.com>, "Richard Herold \(E-mail\)" <heroldra@bp.com>, "Valerie Crissey \(E-mail\)" <vcrissey@chevrontexaco.com> cc Subject Benzene Health Research Consortium Meeting Tuesday, Nov 1, 3 PM BHRC Members; Brian Doll and I talked this afternoon and decided that the consortium would be well served by meeting together prior to the start of the annual meeting. There are a number of things to discuss, for example: * final logistics of the annual meeting * our meeting with the Pis SH ELL-MCCLU RG-052990 * the possibility of another annual meeting 4Q06/1 Q05 * initiating planning for a benzene symposium Brian will develop a draft agenda and send it out along with the details of getting to XOM. We will end by 5 in order to give ourselves time to get back to the hotel for dinner. I will be traveling Friday, Oct 28 - Mon, Oct 31, so available only sporadically. I will check voice mail at work and log-in to check email when I get to the hotel Monday night. Travel safely and see you Tuesday afternoon. Regards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals Business Success through HSSE Excellence SHELL-MCCLURG-052991 From: Sent: To: Cc: Subject: Attach: brian. e. doll@exxonmobil.com Friday, September 16, 20058:51 PM (GMT) Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> benzconsort-cc@listserve.api.org; benzconsort-oc@listserve.api.org; benzconsorttc@listserve.api.org; Matt Todd <ToddM@api.org> RE: SHS: Study Summary Revised Summary for symposium BEDoll.doc Patsy, et. aI., I have made a few changes for your consideration that builds on Jennifer's draft. The following changes are consistent with the "Committee Roles and Responsibilities" document on the SHS website: -- Consistently capitalized "Principal Investigators" -- Added "Review" to "Ethics Panel" to make it "Ethics Review Panel" -- Added "independent" to the descriptions of the people on both the SRP and ERP The following were more worksmithinglchanges in style and are open to debate: -- I do not particularly like calling this a "study" in the first paragraph and then saying it is "actually 3 studies" in the second paragraph. In our "Main Messages" document on the website, we refer to this as a "project" when talk about the whole thing, and to 3 studies when talking about the parts. I adopted this convention for the paper. -- I think the word "benzene" should be in the first paragraph unless someone can think of a good reason why it should not be. -- In the last paragraph, would it be more accurate to say it is the "results of the studies" rather than the "study" that we want to become a part of the body of scientific research on benzene? Have a good weekend. Regards, Brian (See attached file: Summary for symposium BEDoll.doc) "Clegg, Patsy M SCC-CHSE-PC" <patsy.clegg@s To hell.com> "Matt Todd" <ToddM@api.org>, <benzconsort-oc@listserve.api.org>, <benzconsort-tc@listserve.api.org>, 09/16/05 01 :23 <benzconsort-cc@listserve.api.org> PM cc Subject RE: SHS: Study Summary Revised Good rewrite. My spell-check identified that well-managed should not be hyphenated. Patsy -----Orig inal Message----From: Matt Todd [mailto:ToddM@api.org] SH ELL-MCCLU RG-052992 Sent: Thursday, September 15, 2005 10:59 AM To: benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsort-cc@listserve.api.org Subject: RE: SHS: Study Summary Revised BHRC Committee Member: Due to significant comments and changes to the SHS Summary document, please review the attached, revised version instead of the document that was circulated on 9/13. The deadline for review and comment remains October 7th. Regards, Matt From: Matt Todd Sent: Tuesday, September 13, 2005 12:09 PM To: BHRC Oversight Committee (benzconsort-oc@listserve.api.org); BHRC Technical Committee (benzconsort-tc@listserve.api.org); BHRC Communications Committee (benzconsort-cc@listserve.api.org) Subject: SHS: Study Summary BHRC Committee Member: Please review the attached SHS Study Summary and provide comments back to me by COB October 7th. This document will be distributed to the SHS Symposium attendees to provide an overview of the study. Regards, Matt Matthew Todd American Petroleum Institute 1220 L Street NW Washington DC 2005 www.api.org SH ELL-MCCLU RG-052993 Shanghai Health Study Descriptive Overview DRAFT In December 2003, a gathering in Shanghai, China marked the opening of the Joint Sino-U.S. Clinical and Molecular Laboratory. This opening marked the formal beginning of the Shanghai Health Study, an unusual a cooperative research project involving leading researchers from the U.S. and China, facilities at Fudan University, a network of Shanghai hospitals, with U.S. oil and chemical company support. The research project has been underway since then to further the understanding of the human health effects of benzene, with data collection scheduled for completion late next year (2006). Purpose: The project is a series of studies designed to advance the medical and scientific understanding of the relationship between benzene exposure and the risk of certain hematopoietic diseases (certain blood and lymph related disorders). The sponsor companies consider the project an important element factor in their product stewardship programs. A unique set of circumstances in Shanghai enabled investigators to launch this meaningful benzene research. These include a long history of working with occupational exposures and qualified, experienced investigators familiar with the local scientific, medical and regulatory establishments. The studies should contribute to the scientific literature regarding a number of issues that have long complicated benzene health risk assessment. The Studies: The program involves three inter-related studies: Case-Control Study - A hospital-based case control study investigating the potential relationship between exposures to benzene, other diverse variables and both Non-Hodgkins Lymphoma (NHL) and Acute Myelogenous Leukemia (AML). Disease Progression Study - A hospital and clinic-based investigation of the potential relationship between non-cancer diseases of the bone marrow and AML to determine if effects on bone marrow progress through non-cancer stages to an ultimate leukemia. This study is also attempting to define the shape of the dose response for possible "precursor" diseases. This study could result in characterization of unique identifiers of benzene-induced AML. Molecular Epidemiology Study - An investigation of whether there is a quantitative relationship between benzene exposure and potential early biological indicators of both exposure and effect in a focused population of workers. The combined studies apply new technologies to advance the medical and scientific knowledge of benzene-induced disease. The investigators are leading experts in their fields. The three Principal Investigators are Dr. Fu Hua of Fudan University, Dr. Richard Irons of the University of Colorado Health Sciences Center, and Dr. Otto Wong of Applied Health Sciences (an independent U.S. research firm). Benefits: Beyond advancing knowledge of benzene toxicology, these studies will further assist the contributing companies in their continuing efforts to achieve the provide highest quality product stewardship geals and continuous development improvement of their risk management programs. In addition, the studies may contribute to analyses conducted when governments debate future regulatory standards. 1 SH ELL-MCCLU RG-OS2994 Challenges: The studies have met several technical and ethical challenges. Technical- Scientific Review Panel In order to stand up to rigorous scientific standards, studies must pass scientific scrutiny, be well-managed, and incorporate the best technology. State-of-the-art research is absolutely necessary to make real progress in developing a sound risk assessment. To that end, a Scientific Review Panel was assembled, made up of independent leading experts from a number of fields relevant to these studies. They reviewed, commented on, and after revisions, endorsed the research protocols. Additionally, the protocols also met the rigorous requirements of three separate Use of Human Subjects Committees (Institutional Review Board or IRB), two in the US and one in China. The Scientific Review Panel has also met with the Principal Investigators to hear about progress and provide their perspectives on issues that arise. They will remain available to the investigators throughout the research program. Ethical- Ethics Review Panel To address ethical issues posed by the project, the protocols have undergone a thorough analysis to ensure that they meet international standards for research involving humans (guidelines established by the Council for International Organizations of Medical Sciences or CIOMS). An Ethics Review Panel is part of the oversight for the proj ect. It consists of independent bioethicists from the U. S., China and Europe. This panel also consults with the Principal Investigators during the course of the research. Collaboration: A key to the 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 latter two are responsible for occupational exposure monitoring and enforcement in Shanghai). Equally critical is the Joint Sino-U.S. Clinical and Molecular Laboratory which was developed for this research project. This state-of-the-art clinical and molecular laboratory operates on the Fudan Medical University campus. It supports the research studies as well as providing diagnostic services for over 30 major hospitals in the Shanghai region. The facility will remain at Fudan once the project is completed. This sustainable technology transfer is an important aspect of the project design. Conclusion: The project sponsors (listed below) are committed to seeing that the Shanghai Health Study is conducted in an open manner, and with the assurance of the investigators' research independence in conducting the studies, analyzing the data, and publishing their conclusions. The sponsors' goal is for the results of the studies to become an important part of the body of scientific research on benzene. BP Chevron ConocoPhillips ExxonMobil Shell Chemical With Additional FlUlding from Marathon 2 SH ELL-MCCLU RG-052995 From: Sent: To: Subject: Attach: Galvin, Jennifer B <Jennifer.B.Galvin@conocophillips.com> Friday, September 16, 2005 2:19 PM (GMT) Johnston, Michael D. <MIKE.D.Johnston@conocophillips.com>; Matt Todd <ToddM@api.org>; benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsort-cc@listserve.api.org RE: SHS: Study Summary Revised SHS_summary. doc I have made further corrections in addition to Mike's changes. My changes, also, are minor. My changes are in blue. The "Technical" paragraph is highlighted in blue, so it looks as though I changed the whole paragraph, but I didn't. It inadvertently got shifted down a line, hence the color. Thanks, Jennifer Galvin 918-661-3865 918-662-1139 (fax) 918-519-6302 (cell) -----Original Message----From: Johnston, Michael D. Sent: Thursday, September 15, 2005 4: 13 PM To: Matt Todd; benzconsort-oc@listserve.apLorg; benzconsort-tc@listserve.apLorg; benzconsortcc@listserve.api.org Subject: RE: SHS: Study Summary Revised I made a few minor changes for consideration. -----Original Message----From: Matt Todd [mailto:ToddM@apLorg] Sent: Thursday, September 15, 2005 10:59 AM To: benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsort-cc@listserve.api.org Subject: RE: SHS: Study Summary Revised BHRC Committee Member: Due to significant comments and changes to the SHS Summary document, please review the attached, revised version instead of the document that was circulated on 9/13. The deadline for review and comment remains October 7th. Regards, Matt From: Matt Todd Sent: Tuesday, September 13, 2005 12:09 PM To: BHRC Oversight Committee (benzconsort-oc@listserve.apLorg); BHRC Technical Committee (benzconsort-tc@listserve.apLorg); BHRC Communications Committee (benzconsort-cc@listserve.apLorg) Subject: SHS: Study Summary BHRC Committee Member: Please review the attached SHS Study Summary and provide comments back to me by COB October 7th. This document will be distributed to the SHS Symposium attendees to provide an overview of the study. SH ELL-MCCLU RG-OS2996 Regards, Matt Matthew Todd American Petroleum Institute 1220 L Street NW Washington DC 2005 www.api.org SH ELL-MCCLU RG-OS2997 Shanghai Health Study Descriptive Overview DRAFT In December 2003, a gathering in Shanghai, China marked the opening of the Joint Sino-U.S. Clinical and Molecular Laboratory. This opening marked the formal beginning of the Shanghai Health Study, an unusual a cooperative research partnership involving leading researchers from the U.S. and China, facilities at Fudan University, a network of Shanghai hospitals, with U.S. oil and chemical company support. The study has been underway since then, with data collection scheduled for completion late next year (2006). Purpose: The study is actually a series of studies designed to advance the medical and scientific understanding of the relationship between benzene exposure and the risk of certain hematopoietic diseases (certain blood and lymph related disorders). The sponsor companies consider the study an important element factor in their product stewardship programs. A unique set of circumstances in Shanghai enabled investigators to launch this meaningful benzene research. These include a long history of working with occupational exposures and qualified, experienced investigators familiar with the local scientific, medical and regulatory establishments. The studies should contribute to the scientific literature regarding a number of issues that have long complicated benzene health risk assessment. The Studies: The program involves three inter-related studies: Case-Control Study - A hospital-based case control study investigating the potential relationship between exposures to benzene, other diverse variables and both Non-Hodgkins Lymphoma (NHL) and Acute Myelogenous Leukemia (AML). Disease Progression Study - A hospital and clinic-based investigation of the potential relationship between non-cancer diseases of the bone marrow and AML to determine if effects on bone marrow progress through non-cancer stages to an ultimate leukemia. This study is also attempting to define the shape of the dose response for possible "precursor" diseases. This study could result in characterization of unique identifiers of benzene-induced AML. Molecular Epidemiology Study - An investigation of whether there is a quantitative relationship between benzene exposure and potential early biological indicators of both exposure and effect in a focused population of workers. The combined studies apply new technologies to advance the medical and scientific knowledge of benzene-induced disease. The investigators are leading experts in their fields. The three Principal Investigators are Dr. Fu Hua of Fudan University, Dr. Richard Irons of the University of Colorado Health Sciences Center, and Dr. Otto Wong of Applied Health Sciences (an independent U.S. research firm). Benefits: Beyond advancing knowledge of benzene toxicology, these studies will further assist the contributing companies in their continuing efforts to achieve the provide highest quality product stewardship geals and continuous development improvement of their risk management programs. In addition, the studies may contribute to analyses conducted when governments debate future regulatory standards. 1 SH ELL-MCCLU RG-OS2998 Challenges: The studies have met several technical and ethical challenges. Technical- Scientific Review Panel In order to stand up to rigorous scientific standards, studies must pass scientific scrutiny, be well-managed, and incorporate the best technology. State-of-the-art research is absolutely necessary to make real progress in developing a sound risk assessment. To that end, a Scientific Review Panel was assembled, made up ofleading experts from a number of fields relevant to these studies. They reviewed, commented on, and after revisions, endorsed the research protocols. Additionally, the protocols also met the rigorous requirements of three separate Use of Human Subjects Committees (Institutional Review Board or IRB), two in the US and one in China. The Scientific Review Panel has also met with the principal investigators to hear about progress and provide their perspectives on issues that arise. They will remain available to the investigators throughout the research program. Ethical- Ethics Panel To address ethical issues posed by the study, the protocols have undergone a thorough analysis to ensure that they meet international standards for research involving humans (guidelines established by the Council for International Organizations of Medical Sciences or CIOMS). An Ethics Panel is part of the oversight for the project. It includes bioethicists from the U.S., China and Europe. This panel also consults with the principal investigators during the course of the research. Collaboration: A key to the 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 latter two are responsible for occupational exposure monitoring and enforcement in Shanghai). Equally critical is the Joint Sino-U.S. Clinical and Molecular Laboratory which was developed for this research project. This state-of-the-art clinical and molecular laboratory operates on the Fudan Medical University campus. It supports the research studies as well as providing diagnostic services for over 30 major hospitals in the Shanghai region. The facility will remain at Fudan once the project is completed. This sustainable technology transfer is an important aspect of the project design. Conclusion: The study sponsors (listed below) are committed to seeing that the Shanghai Health Study is conducted in an open manner, and with the assurance of the investigators' research independence in conducting the study, analyzing the data, and publishing their conclusions. The sponsors' goal is for the study to become an important part of the body of scientific research on benzene. BP Chevron ConocoPhillips ExxonMobil Shell Chemical With Additional FlUlding from Marathon 2 SH ELL-MCCLU RG-OS2999 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Wednesday, August 3,20058:16 PM (GMT) benzconsort-tc@listserve.api.org; Jerry Rice (E-mail)<Jmricewas@ao1.com> Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com>; benzconsortcc@listserve.api.org BHRC-TC... Conf Call wi Dr. Rice - Symposium - Mon 08 Aug, 3pm EDT Prelim Invitees 03Aug2005.doc; Symposium Pgm Rev01 28Ju12005.doc BHRC Technical Committee (TC) - We have scheduled a TC Conf Call with Dr. Jerry Rice on Monday (Aug 8th) at 3:00pm Eastern... AGENDA Nov 4th SHS Symposium -- draft agenda (see attached) -- invitations I list of invitees (see attached) -- list action items I timeline -- other items? CONFERENCE CALL Date: Mon, 08 August Time: 3:00pm Eastern (2:00pm Central, 12:00pm Pacific) Phone: 1-770-765-9147 PIN: 2026828319# Thank you! Bruce. SH ELL-MCCLU RG-053000 18t Draft 28/0712005 SYMPOSIUM The Shanghai Health Study: Health Consequences of Exposure to Benzene Leavey Conference Center Georgetown University, Washington, DC 4 November 2005 8:00 - 8:30 Registration and continental breakfast Session 1 Chair: P. Lombardo, University of Virginia (ERP) 8:30 - 9:00 Welcome and Introduction (GU representative; Consortium representative) 9:00 - 9:30 Benzene: What's known and what isn't R. Albertini, Univ of Vermont (SRP) 9:30 -10:00 The Shanghai Health Study: Fudan University and Participating Shanghai Hospitals Hua Fu, Fudan University, Shanghai, China (Co-PI) 10:00 - 10:30 Ethical considerations in the Shanghai Health Study E. Clayton, Vanderbilt University (ERP) 10:30 - 10:45 Coffee Session 2 (Chair: TBD, from SRP) 10:45 - 11 :15 Myelodysplasia and myeloid leukemias: Etiology and gaps in knowledge R. Larson, University of Chicago (SRP) 11 :15 - 11 :30 The Diagnostic Laboratory R. Irons, University of Colorado (Co-PI) 11 :30 - noon The Disease Progression Study: Early findings R. Irons, University of Colorado (Co-PI) 12:00 - 12:30 The Molecular Epidemiology Study TBD 12:30 -1 :30 Lunch 1 SHELL-MCCLURG-053001 18t Draft 28/0712005 1:30 - 2:00 2:00 - 2:30 2:30 - 3:00 3:00 - 3:15 3:15 - 3:45 3:45 - 4:00 4:00-4:15 Session 3 (Chair, TBD, from SRP) Lymphoid neoplasms and the WHO classification: Etiology and gaps in knowledge J. Rice, Georgetown University (SRP) The challenge of exposure assessment T. Armstrong, ExxonMobil Corporation (Co-PI) The Hospital-based Case-Control Study o. Wong, Applied Health Sciences, Inc. (Co-PI) Tea Session 4 Chair, H. Greim (SRP) Milestones and future plans R. Schnatter, ExxonMobil Corporation (Co-PI) General Discussion Summary and closure, followed by informal discussions 2 SH ELL-MCCLU RG-053002 DRAFT { DATE \@ "M/d/yyyy" } SHS Symposium, 4 November 2004 Preliminary list of Invitees (72) 1. Names from Consortium Sponsors (9) Chinese Embassy Zhou Wenzhong, Ambassador Li Jun Lan, Deputy Chief of Mission Jin Xiaoming, Minister-Counsellors, Science and Technology State Jame Donovan, Director, Office of Chinese and Mongolian Affairs Michael Finegan, Energy, Environment and Labor/Space/Public Heath, Office of Chinese and Mongolian Affairs Energy Robert S. Price, Director, Office of European and Asian Affairs US-China Business Council John Frisbie, President Center for Strategic and International Studies (CSIS) Dr. Bates Gill, Freeman Chair for China Studies Robert W. Haines Manager, International Government Relations Exxon Mobil Corporation 2000 K Street, N.W., Suite 710 Washington, DC 20006 (202) 862-0245 (202) 253-3144 - cell (202) 862-0269 - fax Email: robert.w.haines@exxonmobil.com 2. SRP and ERP Members and API/Consortium observers (16) SRP Members jmricewas@aol.com guilanli@263.net.cn checko@u.washington.edu helmut.greim@lrz.tum.de herbst@pitt.edu john.cherrie@iomhq.org.uk minden@uhnres.utoronto.ca ralbert315@aol.com rlarson@medicine.bsd.uchicago.ed 1 SH ELL-MCCLU RG-053003 DRAFT { DATE \@ "M/d/yyyy" } herrick@hohp.harvard.edu ERP -- ERP Members ellen.w.clayton@vanderbilt.edu idanpaani@who.int paI8g@virginia.edu xzllzx@citiz. net SRP & ERP: TC Observers I API Staff jennifer.b.galvin@conocophiliips.com stuart.cagen@shell.com twerdokl@api.org jarnotb@api.org 3. Pis (6) Richard Irons, MD 4800 Baseline Road #E104-253 Boulder, CO 80303 richard. irons@uchsc.edu Otto Wong, ScD Applied Health Sciences, Inc. 181 Second Avenue, Suite 628 POB 2078 San Mateo, CA 94401 ottowong@aol.com Fu Hua Fudan University Medical Center PO Box 203 138 Yi Xue Yuan Road Shanghai, 200032 P.R. China hfu@shmu.edu.cn Liang You-xin Department of Occupational Health Fudan University School of Public Health 138 Yi Xue Yuan Road Shanghai, 200032 P.R. China yxliang@shmu.edu.cn 2 SH ELL-MCCLU RG-053004 DRAFT { DATE \@ "M/d/yyyy" } Robert Schnatter ExxonMobil Biomedical Sciences, Inc. 1545 Route 22 East POB 971 Annandale, NJ 08801-0971 a.r.schnatter@exxonmobil.com Thomas Armstrong ExxonMobil Biomedical Sciences, Inc. 1545 Route 22 East POB 971 Annandale, NJ 08801-0971 thomas. w. armstrong@exxonmobil. com 4. BHC Oversight Committee (6) Chair - Patsy M. Clegg Shell Chemical Product Stewardship, HSE PO Box 4320 Houston, TX 77210 Vice-Chair Brian Doll ExxonMobil Corp. 3225 Gallows Road Fairfax, VA 22037 Members: Donald M. Burnett, PhD BP p.1.c. BP, Product Stewardship & Toxicology 150 West Warrenville Road MC5A Naperville, IL 60563 Michael D. Johnston ConocoPhillips 600 North Dairy Ashford Road Houston, TX 77079 Zachary A. Wong Manager, Toxicology & Hlth Risk Assess Chevron Corporation Energy Technology Company 100 Chevron Way PO Box 1627 Richmond, CA 94802-0627 3 SH ELL-MCCLU RG-053005 DRAFT { DATE \@ "M/d/yyyy" } Alternate Stephen Bowes ExxonMobil 3225 Gallows Rd. Room 8B0428 Fairfax. VA 22037-0001 5. BHC Communications Committee (1) Lynn Russo ExxonMobil Corporation Communications 3225 Gallows Road Committee Representative Room 700232 Fairfax, VA 22037-0001 6. BHC Technical Committee (6) Chair, Jennifer B. Galvin, PhD, ConocoPhillips 12 A1 Phillips Building 411 S Keeler Bartlesville, OK 74004 Vice-Chair, Stuart Cagen, PhD Staff Toxicology Advisor Shell Chemical Co One Shell Plaza 91 0 Louisiana, 18th Floor Houston, TX 77002 Anita Balaraman Chevron Corporation Energy Technology Company 100 Chevron Way PO Box 1627 Richmond, CA 94802-0627 Michael G. Bird ExxonMobil 1545 Route 22 East Annandale, NJ 08801-0971 Stephen Bowes ExxonMobil 3225 Gallows Rd. Room 880428 Fairfax, VA 22037-0001 4 SH ELL-MCCLU RG-053006 DRAFT { DATE \@ "M/d/yyyy" } Donald M. Burnett, PhD, BP p.l.c. BP, Product Stewardship & Toxicology 150 West Warrenville Road MC5A Naperville, IL 60563 7. Munich Symposium Selected Attendees (highlighted) (not incl. NCI) (11) Bond Goldstein Henderson Kipen Levy Osheroff Rappaport Ross Smith Snyder Trush James Bernard Rogene Howard Leonard Neil Stephen David Martyn Robert Michael toxcon@earthlink.net bdgold@pitt.edu rhenders@lrri.org Chemico-Biological Interactions University of Pittsburgh Lovelace Institute University of Medicine and Dentistry of New Jersey IsI1@le.ac.uk University of Leicester Vanderbilt University University of North Carolina smr@unc.edu University of Colorado UC Berkeley Rutgers, The State University of New Jersey mtrush@ jhsph.edu Johns Hopkins University 8. NCI [from PubMed lit. search and Munich Symposium list] (7) Rothman Hayes Lan Dosemeci Travis Linet Blair Nathaniel Richard B. Qing M Lois Martha Aaron National Cancer Institute hayesr@mail.nih.gov National Cancer Institute qingl@mail.nih.gov NCI 9. EPA (Washington and North Carolina) (3) Sonawane Farland Preston Robert William Julian Environmental Protection Agency EPA, DC EPA, NHEERL, NC 10. Tox Forum contacts (7) Eileen Abt National Research Council/NAS 500 Fifth Street, NW Washington, DC 20001 eabt@nas.edu 5 SH ELL-MCCLU RG-053007 DRAFT { DATE \@ "M/d/yyyy" } Richard A. Canady OSTP, Executive Office of the President 1650 Pennsylvania Avenue, NW Washington, DC 20502 rcanady@ostp.eop.gov Elaine Faustman University of Washington PO Box 354695 Seattle, WA 98105-6099 faustman@u.washington.edu Carol J.M. Henry American Chemistry Council 1300 Wilson Boulevard Arlington, VA 22209 Carol henry@americanchemistry.com Michael P. Holsapple ILSI One Thomas Circle, NW, 9th Floor Washington, DC 20005-5802 mholsapple@ilsi.org Steve Olin ILSI One Thomas Circle, NW, 9th Floor Washington, DC 20005-5802 solin@ilsi.org David Longfellow Toxicology Forum 5102 Marlyn Drive Bethesda, MD 20816-1938 otterspace@verizon. net 11. Georgetown University (?) 6 SH ELL-MCCLU RG-053008 From: Sent: To: Subject: Attach: Matt Todd <ToddM@api.org> Friday, July 29, 2005 6:32 PM (GMT) Tsai, Shan P SHLOIL-SHS <shan.tsai@shell.com> 2005 SHS Annual Meeting 2005_SHS_Annual_Meeting_Regi stration. doc Hi Shan, I have not received your registration form (attached) to attend the Shanghai Health Study Annual Meeting. I believe you intend on attending the meetings but were possibly waiting for the Benzene Symposium date to be set. Now that it's set for November 4th, will you complete the attached registration form and return it to me via email. A block of rooms was reserved for the meeting dates by ExxonMobil, but attendees must contact the hotel directly to arrange for their stay. The phone number for the Ritz in Tyson's Corner is 703-506-4300. Thanks, Matt Matthew Todd Regulatory Analysis and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005 p: (202)682-8319 f: (202)682-8031 www.api.org SH ELL-MCCLU RG-053009 From: Sent: To: Subject: Attach: Robin Tillery <tilleryr@api.org> Friday, September 30, 20057: 10 PM (GMT) Tsai, Shan P SHLOIL-SHS <shan.tsai@shel1.com> Symposium Invitation: Health Consequences of Exposure to Benzene Symposium Program. pdf Shanghai Health StudyHealth Consequences ofExposure to Benzene Georgetown University, Washington DC, November 4, 2005 Dear Shan, You are invited to attend a one-day symposium on research sponsored by the Sino-American Shanghai Health Study, a petroleum industry-sponsored multi-year biomedical research project coordinated by the American Petroleum Institute. The program will be of interest to biomedical researchers with an interest in occupational cancer risks, in benzene metabolism and toxicology, and more generally in biomedical research cooperation between universities in the United States and the Peoples' Republic of China. A preliminary program for the Symposium is attached. Toxicity of benzene to bone marrow has been recognized for many years, and benzene is a known human occupational carcinogen. Despite its toxicity, and despite increasingly strict regulatory limits on its use in many countries, benzene continues to be widely used as a cheap and effective solvent. Human exposures to benzene at various levels thus continue to occur. The Shanghai Health Study is designed to investigate several aspects of benzene toxicity, including its possible causal relationship to malignancies other than acute myeloid leukemia. The Study is being conducted by Chinese and American scientists in cooperation with Fudan University, Shanghai, China, and 29 participating hospitals within that city. It receives oversight from two external review panels of academic scientists and biomedical ethicists. The Symposium will be held at the Leavey Conference Center, Georgetown University, Washington, DC, on November 4,2005, from 8:30 a.m. until approximately 3:30 p.m. Continental breakfast, beginning at 8:00 a.m., and lunch will be provided to all registrants. Hotel rooms are available at a reduced rate in the Leavey Center Marriott Hotel, gucc@georgetown.edu. Attendance is by invitation. There is no registration fee. The organizers hope you will be able to accept this invitation, and I look forward to welcoming you to the Symposium. Please RSVP by reply to this e-mail, along with any questions you may have regarding this event. Sincerely, Jerry M. Rice Symposium Chair SHELL-MCCLURG-053010 SYMPOSIUM: Health Consequences of Exposure to Benzene Leavey Conference Center, Georgetown University, Washington DC November 4, 2005 8:00 - 8:30 AM 8:30 - 9:00 AM Registration and Continental Breakfast Welcome and Introduction Jerry Rice, Georgetown University SESSION 1 Chair: Ellen Clayton, Vanderbilt University 9:00 - 9:30 AM 9:30 - 10:00 AM 10:00 - 10:30 AM 10:30 - 10:45 AM Benzene: What's Known and What Isn't about Health Effects Richard Albertini, University of Vermont The Shanghai Health Study: Fudan University and Participating Shanghai Hospitals Fu Hua, Fudan University, Shanghai Ethical Considerations: Obtaining Informed Consent Juhana Idanpaan-Heikkila, Council for International Organizations of Medical Sciences Coffee SESSION 2 10:45 - 11:15AM 11: 15 - 11 :30 AM 11:30 - 12:00 PM 12:00 - 12:30 PM 12:30 - 1:30 PM Chair: Helmut Greim, Technical University of Munich Lymphoid Neoplasms and the WHO Classification: Etiology and Gaps in Knowledge Jerry Rice, Georgetown University The Diagnostic Laboratory at Fudan University Richard Irons, University of Colorado & Fudan University The Challenge of Exposure Assessment Tom Armstrong, ExxonMobii Biomedical Sciences The Hospital Based Case-Control Study Otto Wong, Applied Health Sciences Lunch SESSION 3 Chair: John Cherrie, Council for International Organizations of Medical Sciences 1:30-2:00PM What We Think We Know About the Etiology of Myelodysplasia and Myeloid Leukemia Richard Larson, University of Chicago 2:00 - 2:30 PM The Disease Progression Study: Early Findings Richard Irons, University of Colorado & Fudan University 2:30 - 3:00 PM The Molecular Epidemiology Study A. Robert Schnatter, ExxonMobii Biomedical Sciences 3:00 - 3:10 PM Summary and Closure Jerry Rice, Georgetown University 3:10 - 3:30 PM Tea SHELL-MCCLURG-053011 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Friday, September 30, 2005 1:27 PM (GMT) benzconsort-tc@listserve.api.org benzconsort-oc@listserve.api.org; benzconsort-cc@listserve.api.org BHRC-TC... Dr. Rice's Fudan University trip report Trip Report.pdf BHRC Technical Committee - Jerry Rice returned recently from his site visit to Fudan University, with an overall positive first-hand impression of Shanghai Health Study activity, status and facilities. Details of his visit are summarized in the attached trip report (2-page pdf file). A copy of Dr. Rice's report and the original invitation letter will be posted to the SHS web site. I'll coordinate the upcoming Technical Committee conference call with Jerry's schedule, providing an opportunity to answer questions and allowing him to expand on details while memories are still fresh. Best Regards - Bruce. From: Jmricewas@aol.com [mailto:Jmricewas@aol.com] Sent: Thursday, September 29,2005 1:19 PM To: Bruce Jarnot Subject: Trip report Bruce, I attach a brief trip report on my visit to Shanghai earlier this month, together with a copy of the invitation that prompted this visit. Jerry SHELL-MCCLURG-053012 From: Sent: To: Subject: Attach: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Tuesday, November 29, 2005 6:05 PM (GMT) Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Michael Johnston <Mike. dJohnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Jennifer Galvin (E-mail)<jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail) <russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SCC-DCSI261 <sc724012@shell.com>; Colletti, Sarah J SCC-DCSI14 <sarah.colletti@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com>; John Wagner (E-mail) <wagner@api.org>; Mark Fitzsimmons (E-mail)<mfitzsim@steptoe.com> SHS presentation to API RES - GC - PLEASE REVIEW AND COMMENT RESGC Presentation - Nov 2005.zIP Team; We have been invited to do an update of the SHS to the API HES GC meeting in Houston tomorrow. We just did a presentation in June, so I have elected to focus on the annual meeting and symposium. If you would please give this a quick review. I will be leaving Shell about 11 in the morning to drive to ConocoPhillips, so I can make some last minute changes. Thanks! Patsy Clegg Product Steward Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals SHELL-MCCLURG-053013 The Shanghai Health Study Patsy Clegg Chair, Oversight Committee Shell Chemicals LP November 30, 2005 SHELL-MCCLURG-053014 Shanghai Health Study Update ~) 3rd Annual Meeting - November 2-3, 2005 !:i~::I:~i:~: Presentations by: iIi:Ii Jerry Rice, Chair Scientific Review Panel History of Shanghai Health Study Ethical Issues Objectives of 3 studies - Case Control: Determine risk of developing AML or NHL among workers exposed to benzene - Disease Progression: Characterize benzene dose response from benzene poisoning to potential AA, MDS, AML - Molecular Epidemiology: Identify biomarkers SHELL-MCCLURG-053015 Shanghai Health Study Update C,) 3rd Annual Meeting - November 2-3, 2005 !:~::I:~:! Presentations by: ::':: Richard Irons, Principal Investigator, U of Colorado JCML - Sino-US Joint Clinical and Molecular Laboratory - Supports 3 studies with diagnostics - 30 Shanghai hospitals referring cases - Tissue Bank - 15 different analyses - Through Oct OS, have done 1716 diagnoses (50% over prediction) - Nutritional Anemias are an example of a confounder SHELL-MCCLURG-053016 Shanghai Health Study Update C,) 3rd Annual Meeting - November 2-3, 2005 !:~::I:~:! Presentations by: ::':: You-xin Liang, Fudan University Literature review of benzene exposure in the shoe making industry in China 100/0 of SHS cases work in shoe industry Average benzene exposure 2002-2005 is 70 mgjm3 SHELL-MCCLURG-053017 Shanghai Health Study Update f) 3rd Annual Meeting - November 2-3, 2005 :~:~I:~:~: Presentations by: ::}:I: Otto Wong, Principal Investigator, Applied Health Sciences Investigating 2 diseases: AML & Lymphoid neoplasms (not NHL) Use hospital cases only - high participation rate 0.70/0 refused) Interview - compensated approximately $30 US 4000 interviews; 259 benzene exposed subjects SHELL-MCCLURG-053018 Shanghai Health Study Update ~) 3rd Annual Meeting - November 2-3, 2005 :~:~:I:~::~ Presentations by: :::::!::I: Rob Schnatter - EMBSI - Molecular Epi Study Phase 1: Retrospective analysis of blood parameters versus historic benzene exposures Phase 2: Cross-sectional analysis of blood counts taken during clinical exams versus current benzene exposures SHELL-MCCLURG-053019 Shanghai Health Study Update ~) 3rd Annual Meeting - November 2-3, 2005 :~:~:I:~::~ Presentations by: :::::!::I: Tom Armstrong - EMBSI - Exposure Assessment Tiered Design Ever exposed / Never Exposed Qualitative Ranges Semi-quantitative Ranges Qualitative & Pattern of Exposure Sector analysis SH ELL-MCCLU RG-053020 Shanghai Health Study Update :~::.::~: 3rd Annual Meeting - November 2-3, 2005 :t::::::::: Presentations by: :::: Richard Irons - Disease Progression Study 2 Findings of particular interest - 63/303 (20%) AA, MDS, Leukemia cases confirmed nutritional anemias - Prevalence of MDS Subtypes - paper published Applying WHO definitions NHL subtypes Chronic exposure to benzene results in a unique form of dysphasia - BID - paper published SHELL-MCCLURG-053021 Shanghai Health Study Update C,) 3rd Annual Meeting - November 2-3, 2005 !::~:~:I:~::! Hi9hIi9hts ::':: WHO classification of tumors applied :::}I:: Nutritional anemias identified :I:'=::::: Benzene Induced Myelodysplastic Syndrome TSCA 8(3) filed :I:';::::: JCML transferred to Fudan University School of Medicine ::::::i::::: Richard Irons is a Professor at Fudan SH ELL-MCCLU RG-053022 Shanghai Health Study Update Health Consequences of Exposure to Benzene Symposium at Georgetown University Sponsored by Jerry Rice Purpose: Share with government and researchers Attendees included EPA, OSHA, NeI, military, HEI SH ELL-MCCLU RG-053023 Shanghai Health Study Update Path Forward Complete data collection Data analysis and publication Celebration SH ELL-MCCLU RG-053024 Benzene Health Research Consortium Sponsoring Companies ~ BP ~ Chevron ~ ConocoPhillips ~ ExxonMobil ~ Shell Chemical LP Marathon/Ashland providing additional support SH ELL-MCCLU RG-053025 Shanghai Health Study .:. Budget .:. Funding Costs $ 26M $ 26M SH ELL-MCCLU RG-053026 Shanghai Health Study Summary :!:~:~.:~:!: Progress on 3 studies II!: Case accrual exceeding predictions IH:!: WHO classification being used :!}I Publications :~::~.::~: JCML Sustainability IH:!: Moved to Fudan U. School of Medicine :!}I Dr. Irons made a professor at Fudan U. School of Medicine :~::i::~: Scientific and Ethics Review Panels involved &committed :~:!::.~::~: On budget SH ELL-MCCLU RG-053027 From: Sent: To: Subject: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Wednesday, October 26,2005 10:06 PM (GMT) Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Cagen, Stuart Z SCC-DCSI261 <stuart.cagen@shell.com>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Michael Johnston <Mike.dJohnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Twerdok, Lorraine (E-mail) <twerdokl@api.org>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Russell White (E-mail)<russellwhite@chevrontexaco.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Colletti, Sarah J SCC-DCSI14 <sarah.colletti@shell.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; Valerie Crissey (E-mail)<vcrissey@chevrontexaco.com> Benzene Health Research Consortium - Meeting Tuesday, Nov 1, 3 PM BHRC Members; Brian Doll and I talked this afternoon and decided that the consortium would be well served by meeting together prior to the start of the annual meeting. There are a number of things to discuss, for example: final logistics of the annual meeting our meeting with the Pis the possibility of another annual meeting 4Q06/1 Q05 initiating planning for a benzene symposium Brian will develop a draft agenda and send it out along with the details of getting to XOM. We will end by 5 in order to give ourselves time to get back to the hotel for dinner. I will be traveling Friday, Oct 28 - Mon, Oct 31, so available only sporadically. I will check voice mail at work and log-in to check email when I get to the hotel Monday night. Travel safely and see you Tuesday afternoon. ~gards, Patsy Patsy Clegg Product Steward, HSSE Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals (Business Success tlirougli JSSP. P.~e{{ence SH ELL-MCCLU RG-053028 From: Sent: To: Cc: Subject: Attach: Paula Podhasky <Podhaskyp@api.org> Tuesday, May 6, 2003 8:28 PM (GMT) Cagen, Stuart Z SCC <stuart.cagen@Shel1.Com>; Samuel, Tarita B SCC <taritao samuel@Shell. Com> BenzConsort-TC@listserve.api.org RE: Benzene cost tracking UC cashflow.xls OOPs forgot to attach this one. It is the UC grant spreadsheet. The Technical Committee may wish to edit and add milestones. pp -----Original Message----From: Paula Podhasky Sent: Tuesday, May 06, 2003 4:08 PM To: Cagen, Stuart Z SCC; Samuel, Tarita B SCC Cc: BenzConsort-TC@listserve.apLorg; BenzConsort-CC@listserve.apLorg Subject: RE: Benzene cost tracking Stu and Tarita, Here is some of the material requested. The Technical Committee is responsible for the research related contracts and therefore will need to identify milestones and associated costs for those contracts. Included under the research umbrella are: ERP, SRP, Fudan, UC Grant, Irons, AHS. Bruce Jarnot is the contact with UC (Mary McConnell). The Communications committee oversees the APCO contract and therefore should provide that information. I do not manage any BHRC contracts but, I do track income, administration costs and other operating expenses and can provide more detail as required. By copy of this email I would like the Technical and Communications Committees to identify milestones and if available the associated cost/payments. Thank you, Paula Podhasky -----Original Message----From: Cagen, Stuart Z SCC [mailto:stuart.cagen@shell.com] Sent: Tuesday, May 06,20033:13 PM To: Paula Podhasky; Samuel, Tarita B SCC Subject: Benzene cost tracking Paula: Tarita Samuel (of Shell Chemical LP) has agreed to look through some of the Shanghai Benzene financials to help the consortium get an improved sense of study costs and projections. I am away on vacation this week, but I spoke with her briefly today about our current situation. What I think we need: 1) tracking study costs, including costs peripheral to the study such as investigator expenses and travel, as well as costs peripheral to the investigators, communications budgets (contractors), and main study administration via API. All of this is captured in a total study budget of almost $ 23 million .. 2) this tracking should be in association with study performance milestones, including projected costs and SH ELL-MCCLU RG-053029 milestones until work is in public literature 3) early warning in possible overspending. I would guess this is going to be an iterative process, with the help of the technical committee for the milestones part. Paula: you or Bruce or Lorraine should still be the direct contacts with the University of Colorado and Applied Health Sciences but Tarita could help frame the questions. Paula: I have not yet seen your note with the spreadsheets for me to forward to Tarita, so please send her a copy when you sent them to me so she is not waiting for me to forward these. Now that I have connected the two of you, please feel free to contact each other directly. Thanks Stuart Stuart Cagen Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713241 1407 Fax: +1 713241 3325 Other Tel: +1 8326463987 Email: stuart.cagen@shell.com Internet: http://www.shell.com/chemicals SH ELL-MCCLU RG-053030 University of Colorado Grant: Cash Flow A 1 2 3 4 5 6 7 r.!.. Cumulative Payment Total 9 10 11 12 Payments 13 14 Personnel 15 Budgeted 16 Operating Expenses 17 Budgeted 18 Subcontracts 19 Budgeted 20 Travel 21 Budgeted 22 Equipment 23 Budgeted 24 Indirect 25 Budgeted 26 TOTALS 27 Budgeted 28 29 Balance 30 31 Notes: 32 33 34 35 36 B Oec-01 1,200,000 C Actual Jun-02 4,099,505 1,200,000 2,899,505 $172,140 $224,883 $13,131 $94,401 $123,629 $688,452 $0 $8,429 $291,568 $253,578 $47,922 $111,454 $648,390 $1,381,197 551,610 2,069,918 1 Payments are made in August 2 Real budget values were used when available. 3 Travel is included for trainees; part of this budget. 4 The large fluctuations in the subcontracts is due to EMBSI invoicing UC for the total amount due at the beginning of their fiscal year 5 The increased "subcontracts" amount for Dec-02 is for 2001-2002 funds due to EMBSI subcontract 6 The Grant ends Dec-06. DE Oec-02 7,515,759 3,416,254 $348,277 $284,061 $1,106,578 $15,518 $665,067 $168,442 $2,587,943 2,898,230 SH ELL-MCCLU RG-053031 University of Colorado Grant: Cash Flow FG H I J K LM N 1 2 3 Projected 4 5 Jun-03 Dec-03 Jun-04 Dec-04 Jun-05 Dec-05 Jun-06 Dec-06 Totals 6 7 8 10,096,509 12,677,259 15,258,009 9 10 11 12 2,580,750 2,580,750 2,580,750 13 14 15 $331,316 $293,007 $282,480 $297,450 $293,713 $310,768 $298,684 $244,179 $3,096,897 16 17 $198,373 $259,003 $228,529 $268,289 $252,851 $301,653 $277,143 $151,160 $2,328,595 18 19 $549,014 $988,733 $449,506 $934,456 $453,377 $860,043 $415,102 $202,694 $6,771,584 20 21 $11,340 $4,127 $3,418 $4,245 $0 $1,852 $1,945 $0 $50,873 22 23 $0 $350,000 $0 $0 $0 $0 $0 $0 $1,560,213 24 25 $140,668 $144,596 $133,751 $148,196 $142,107 $159,711 $150,221 $102,788 $1,449,855 26 27 $1,230,711 $2,039,465 $1,097,683 $1,652,637 $1,142,048 $1,634,027 $1,143,094 $700,822 $15,258,017 28 29 1,667,518 2,208,803 1,111,120 2,039,233 30 31 32 33 34 897,185 1,843,908 700,814 Contract SRP total -8 $ $ $ 13,665,017 1,593,000 15,258,017 35 $15,258,017 36 SH ELL-MCCLU RG-053032 From: Sent: To: Cc: Subject: Attach: Paula Podhasky <Podhaskyp@api.org> Tuesday, May 6, 2003 8:08 PM (GMT) Cagen, Stuart Z SCC <stuart.cagen@Shel1.Com>; Samuel, Tarita B SCC <taritao samuel@Shell. Com> BenzConsort-TC@listserve.api.org; BenzConsort-CC@listserve.api.org RE: Benzene cost tracking benzene.msg; AHS Total Budget Estimates (1-30-02).xls Stu and Tarita, Here is some of the material requested. The Technical Committee is responsible for the research related contracts and therefore will need to identify milestones and associated costs for those contracts. Included under the research umbrella are: ERP, SRP, Fudan, UC Grant, Irons, AHS. Bruce Jarnot is the contact with UC (Mary McConnell). The Communications committee oversees the APCD contract and therefore should provide that information. I do not manage any BHRC contracts but, I do track income, administration costs and other operating expenses and can provide more detail as required. By copy of this email I would like the Technical and Communications Committees to identify milestones and if available the associated cost/payments. Thank you, Paula Podhasky -----Original Message----- zFrom: eagen, Stuart see [mailto:stuart.cagen@shell.com] Sent: Tuesday, May 06,20033:13 PM To: Paula Podhasky; Samuel, Tarita B see Subject: Benzene cost tracking Paula: Tarita Samuel (of Shell Chemical LP) has agreed to look through some of the Shanghai Benzene financials to help the consortium get an improved sense of study costs and projections. I am away on vacation this week, but I spoke with her briefly today about our current situation. What I think we need: 1) tracking study costs, including costs peripheral to the study such as investigator expenses and travel, as well as costs peripheral to the investigators, communications budgets (contractors), and main study administration via API. All of this is captured in a total study budget of almost $ 23 million .. 2) this tracking should be in association with study performance milestones, including projected costs and milestones until work is in public literature 3) early warning in possible overspending. I would guess this is going to be an iterative process, with the help of the technical committee for the milestones part. Paula: you or Bruce or Lorraine should still be the direct contacts with the University of Colorado and Applied Health Sciences but Tarita could help frame the questions. Paula: I have not yet seen your note with the spreadsheets for me to forward to Tarita, so please send her a copy when you sent them to me so she is not waiting for me to forward these. SH ELL-MCCLU RG-053033 Now that I have connected the two of you, please feel free to contact each other directly. Thanks Stuart Stuart Cagen Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713241 1407 Fax: +1 713241 3325 Other Tel: +1 8326463987 Email: stuart.cagen@shell.com Internet: http://www.shell.com/chemicals SH ELL-MCCLU RG-053034 Table 1. AML and NHL Case-control Study Summary of Activities by Year Applied Health Sciences, Inc. A r 2 Task 3 4 S(1ecific tasks 5 6 S1 7 S2 8 S3 9 S4 10 S5 11 S6 12 S7 13 S8 14 S9 15 S10 16 S11 17 S12 18 S13 19 S14 20 S15 21 S16 22 S17 23 24 General tasks 25 26 G1 27 G2 28 G3 29 G4 30 G5 31 32 Number of meetings and working tri(1s 33 34 35 36 37 38 39 40 41 (1-30-2002) Activity B Finalization of research protocol Development, translation and pre-test of questionnaire Development of database, data linkage and data security Enrollment of study subjects (AML & NHL patients and controls) Interviews of study subjects Acquisition of employment records of study subjects Data entry and data management Data audit Acquisition of exposure data from Shanghai CDC and factories Exposure assessment of individual study subjects Data analysis Presentation of results to Scientific Committee and sponsors in USA Presentation of results to SMU, Shanghai CDC & others in China Preparation of draft report Finalization of report and response to comments Preparation of manuscripts for journal publication Presentations of study at two international conferences Working with Chinese investigators in Shanghai Meetings with the Scientific & Ethics Committees in USA Communication with the Scientific Committee Communication with the Ethics Committee Project management Number of periodic meetings and working trips in Shanghai Number of periodic meetings in USA Meeting in USA to present study results Meeting in China to present study results Presentations at two international conferences C Year 1 DE Project year Year 2 Year 3 FGH Year 4 Year 5 Year 6 X X X XX X XX XX X XX XX X XX XX X XX XX X XX X X XX X X XX X X X X X X X XX X XX XX X XX XX X XX XX X XX XX X XX 43 3 33 33 2 22 1 1 2 SH ELL-MCCLU RG-053035 A 1 Labor for regular activities (time) 2 3 Category 4 Chief Epidemiologist (PI) 5 Biostatistician 6 Statistical programmer 7 Research assistant 8 Administrative assistant 9 Consulting industrial hygienist 10 Consulting hematologist 11 Consulting pathologist 12 Total labor for regular activities 13 14 15 Meetings/working tri(1s (time & eX(1enses) 16 17 18 Meetings in China (8 days @) 19 Meetings in USA (3 days @) 20 Meeting in Europe (4 days @) 21 Total for meetings/meeting trips 22 23 24 Other direct eX(1enses 25 26 27 Fee for IRB members 28 Domestic long-distance calls (in 2001 $) 29 International calls (in 2001 $) 30 Copying (in 2001 $) 31 Postage and express mail (in 2001 $) 32 Total for other expenses (in 2001 $) 33 34 35 GRAND TOTAL (in 2001 $) 36 37 38 TOTAL BUDGET FOR 6 YEARS (IN 2001 $) Table 2. AML and NHL Case-control Study Budget Estimates (in 2001 $) for Applied Health Sciences, Inc. B Hourly rate in 2001 $ $280 $140 $120 $90 $90 $200 $250 $250 CD Year 1 Hours Amount 380 $106,400 140 $19,600 120 $14,400 100 $9,000 80 $7,200 120 $24,000 20 $5,000 20 $5,000 $190,600 EF Year 2 Hours Amount 350 $98,000 120 $16,800 120 $14,400 100 $9,000 80 $7,200 120 $24,000 20 $5,000 20 $5,000 $179,400 GH Project year Year 3 Hours Amount 300 $84,000 120 $16,800 120 $14,400 100 $9,000 80 $7,200 100 $20,000 20 $5,000 20 $5,000 $161,400 IJ Year 4 Hours Amount 300 $84,000 120 $16,800 120 $14,400 100 $9,000 80 $7,200 100 $20,000 20 $5,000 20 $5,000 $161,400 KL Year 5 Hours Amount 400 $112,000 200 $28,000 200 $24,000 150 $13,500 120 $10,800 100 $20,000 20 $5,000 20 $5,000 $218,300 MN Year 6 Hours Amount 100 $28,000 20 $2,800 20 $1,800 $32,600 Unit cost in 2001 $ $26,000 $12,000 $20,000 Year 1 No. Amount 4 $104,000 3 $36,000 $140,000 Year 2 No. Amount 3 $78,000 3 $36,000 $114,000 Year 3 No. Amount 3 $78,000 2 $24,000 $102,000 Year 4 No. Amount 3 $78,000 2 $24,000 $102,000 Year 5 No. Amount 4 $104,000 3 $36,000 $140,000 Year 6 No. Amount 1 $12,000 1 $20,000 $32,000 Year 1 Amount $2,500 $1,200 $1,000 $500 $300 $5,500 $336,100 Year 2 Amount $1,200 $1,000 $500 $300 $3,000 $296,400 Year 3 Amount $1,200 $1,000 $500 $300 $3,000 $266,400 Year 4 Amount $1,200 $1,000 $500 $300 $3,000 $266,400 Year 5 Amount $1,200 $1,000 $500 $300 $3,000 $361,300 Year 6 Amount $1,500 $1,200 $800 $300 $3,800 $68,400 $1,595,000 SH ELL-MCCLU RG-053036 Table 3. AML and NHL Case-control Study Budget Estimates with a 5% Annual Adjustment Applied Health Sciences, Inc. A 1 Project year 2 3 4 Year 1 5 6 7 8 9 Year 2 10 11 12 13 14 Year 3 15 16 17 18 19 Year 4 20 21 22 23 24 Year 5 25 26 27 28 29 Year 6 30 31 32 33 Total B Total for project year (in 2001 $) $336,100 $296,400 $266,400 $266,400 $361,300 $68,400 $1,595,000 C Amount by quarter (in 2001 $) $84,025 $84,025 $84,025 $84,025 $74,100 $74,100 $74,100 $74,100 $66,600 $66,600 $66,600 $66,600 $66,600 $66,600 $66,600 $66,600 $90,325 $90,325 $90,325 $90,325 $34,200 $34,200 D Calendar quarter 4th Q, 2001 1st Q, 2002 2nd Q, 2002 3rd Q, 2002 4th Q, 2002 1st Q, 2003 2nd Q, 2003 3rd Q, 2003 4th Q, 2003 1st Q, 2004 2nd Q, 2004 3rd Q, 2004 4th Q, 2004 1st Q, 2005 2nd Q, 2005 3rd Q, 2005 4th Q, 2005 1st Q, 2006 2nd Q, 2006 3rd Q, 2006 4th Q, 2006 1st Q, 2007 E Adjusted by 5% annual increase $84,025 $88,226 $88,226 $88,226 $77,805 $81,695 $81,695 $81,695 $73,427 $77,098 $77,098 $77,098 $77,098 $80,953 $80,953 $80,953 $109,791 $115,280 $115,280 $115,280 $43,649 $45,831 $1,841,382 F Total by calendar year G Total for 2001 - $84,025 Total for 2002 = $342,484 Total for 2003 = $318,512 Total for 2004 = $308,391 Total for 2005- $352,649 Total for 2006 = $389,489 Total for 2007 = $45,831 SH ELL-MCCLU RG-053037 Table 4. AML and NHL Case-control study Additional Budget Estimate for Exposure Assessment Applied Health Sciences, Inc. A 1 Labor b~ categor~ 2 3 Category 4 Chief Epidemiologist (PI) 5 Statistical programmer 6 Research assistant 7 Consulting industrial hygienist 8 Total labor for regular activities (2001 $) 9 10 11 Meetings/working tri[!s (time & ex[!enses) 12 13 14 Meetings in China (8 days @) 15 Meetings in USA (3 days @) 16 Total for meetings/working trips (2001 $) 17 18 Total in 2001 $ (labor and trips) 19 20 21 22 Yearl~ budget estimates with a 5% annual adjustment 23 24 Budget by calendar year 25 Total (with 5% annual adjustment) BC D EI F GI H II J K LM Hourly rate in 2001 $ $280 $120 $90 $200 Year 1 Hours Amount 80 $22,400 20 $2,400 20 $1,800 120 $24,000 $50,600 Year 2 Hours Amount 40 $11,200 20 $2,400 20 $1,800 120 $24,000 $39,400 Year 3 Hours Amount 40 $11,200 20 $2,400 20 $1,800 100 $20,000 $35,400 Year 4 Hours Amount 40 $11,200 20 $2,400 20 $1,800 100 $20,000 $35,400 Year 5 Hours Amount 40 $11,200 20 $2,400 20 $1,800 100 $20,000 $35,400 Hours 240 100 100 540 $980 Unit cost in 2001 $ $26,000 $12,000 Year 1 No. Amount 1 $26,000 1 $12,000 $38,000 $88,600 Year 2 No. Amount 2 $52,000 1 $12,000 $64,000 $103,400 Year 3 No. Amount 1 $26,000 1 $12,000 $38,000 $73,400 Year 4 No. Amount 1 $26,000 1 $12,000 $38,000 $73,400 Year 5 No. Amount 1 $12,000 $12,000 $47,400 No. 5 5 10 Year 2002 $93,030 Year 2003 $113,999 Year 2004 $84,970 Year 2005 $89,218 Year 2006 $60,496 SH ELL-MCCLU RG-053038 Table 4. AML and NHL Case-control study Additional Budget Estimate for Exposure Assessment Applied Health Sciences, Inc. N 1 2 otal 3 Amount 4 $67,200 5 $12,000 6 $9,000 7 $108,000 8 $196,200 9 10 11 12 otal 13 Amount 14 $130,000 15 $60,000 16 $190,000 17 18 $386,200 19 20 21 22 23 24 Total 25 $441,712 SH ELL-MCCLU RG-053039 Table 5. AML and NHL Case-control Study Total Budget Estimate by Year Applied Health Sciences, Inc. A 1 2 Year 3 4 2001 5 6 2002 7 8 2003 9 10 2004 11 12 2005 13 14 2006 15 16 2007 17 18 19 Total B Original budget (Table 3) $84,025 $342,484 $318,512 $308,391 $352,649 $389,489 $45,831 $1,841,382 C Additiional budget for Exposure assessment (Table 4) $0 $93,030 $113,999 $84,970 $89,218 $60,496 $0 D Total $84,025 $435,514 $432,511 $393,361 $441,867 $449,985 $45,831 $441,713 $2,283,095 SH ELL-MCCLU RG-053040 From: Sent: To: Subject: Attach: Paula Podhasky <Podhaskyp@api.org> Tuesday, May 6, 2003 6:21 PM (GMT) Paula Podhasky <Podhaskyp@api.org> benzene 7FB20AOO.PDF 7FB20AOO.PDF SH ELL-MCCLU RG-053041 PROGRESS REPORT JUNE 2002 I. ANALYSIS OF DISEASE PROGRESSION FOR APLASTIC ANEMIA, MYELO-DYSPLASTIC SYNDROME, ACUTE MYELOGENOUS LEUKEMIA AND BENZENE POISONING IN SHANGHAI, CHINA II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS IN SHANGHAI, CHINA A MULTICENTER INTERNATIONAL STUDY Molecular Toxicology and Environmental Health Sciences Program Dept. of Pharmaceutical Sciences, School of Pharmacy Department of Pathology, School of Medicine University of Colorado Health Sciences Center, Denver, CO. School of Public Health, Hua Shan Hospital, Cancer Hospital, Fudan University Medical Center, Shanghai, China SH ELL-MCCLU RG-053042 I Introduction A Executive summary 1. Overall Status ofthe Budget NOTE: this is the Semiannual Report of Progress as it Relates to the Budget set forth in our contract and is separate and distinct from the University of Colorado Health Sciences Report of Expenditures and Financial Statement, the Quarterly Report on Field Expenses and the Supplemental Summary Requested by API and the Technical Committee, each of which will be forwarded separately. Unless otherwise stated, actual budget numbers are "as of' May 30, 2002. The overall status of the budget for this fiscal year is as follows: As of May 30, 2002 we have received $4,099,505 against a current approved budget of $4,870,330 exclusive of field expenses. We have expended $1,566,248 as of May 30. At the end of this fiscal year (August 31, 2002) we estimate total expenditures, both encumbered and projected, to be $3,061,859. This will leave a balance of $1,808,471 that includes $1,041,238 in sequestered funds originally earmarked for subject and clinical costs in Year 1. We have been able to maintain an overall positive cash flow in the face of the budgetary shortfall described above that is due to several factors: salary and supply savings achieved as a result of delays in project funding and start-up, exercise of extended budgetary authority and cost shifting in multiple categories, successes in the negotiation of equipment and reagent contracts' and deferral of the payment of incremental increases in EMBSI expenses as part of the revised budget. Because of the delay in project funding, many of the hires and non-capital equipment and reagent purchases scheduled for Fiscal Year 1 (FYI) are being expensed in the last half of the fiscal year. As a result, most of the expenditures estimated for the second half of FYI are actually encumbered at this time. The progress and budgetary status of each project component will be discussed in subsequent chapters. B FY2 Costs and Cash flow 1. Projected Based on the original contract, we will receive $3,416,254 in FY2 against a currently approved budget of $3,284,446. We estimate actual expenses for FY2 to be $4,009,037. The projected differences here are primarily the result of expenses deferred from FYI as a result of the delay in funding, and include charges against training, equipment, database and personnel. By the end of FY2 we estimate the cumulative deficit will be $592,783. In terms of cash flow (not balances) this is more than offset by the subject-related costs sequestered in FYI. It should be noted that the actual subject-related expenses encountered in FY2 and beyond will depend on the number of cases recruited to the studies: the more cases recruited, the less the balance we will 4 SH ELL-MCCLU RG-053043 have on hand. Whether in fact we are able to maintain a positive cash flow in FY2 will depend on subject recruitment. However, it is also obvious that funds originally budgeted to cover subject-related costs that are expensed to cover cash shortfalls will necessarily have to be replaced, probably in early FY3. C Budgetary and contractual issues 1. UCHSC contract At present we have committed to equipment and supply purchases and payment schedules to Chinese entities that reflect the budget approved by the Consortium in December OllJanuary 02. This is being achieved by modifications that reflect realized salary savings and cost shifting at the expense of personnel and operating budgets as discussed in this document. To date, API has not provided UCHSC with any letter of intent or contract addenda to reflect the modified budget S\..."\\ \-t\IC.- changes. In the absence of this, UCHSC will consider the project in default the moment we '"\u ... encounter a negative cash balance. Therefore, under our current contractual arrangements we will not be able to bridge any negative cash balance even for a short period of time. Alternatively, if we are provided a contract modified to reflect the current budget, short term bridging is possible. It is impossible to accurately estimate the timing of these impacts in the absence of being able to predict actual subject accrual rates, but our best estimates suggest a crisis is possible in the latter half of FY2/first half of FY3. Independently, even given a positive cash balance during FY2 we will not be able to modify our payments to EMBSI to reflect their increased costs without a contract addendum. 2. Fudan API contract It appears that API does not yet have a contract with Fudan University to support Case Control Study operation. As a consequence, Fudan has been charging all Project-related expenses, including Case Control Study expenses, against the UCHSC account. To date the impact has been minimal (i.e. we estimate approximately $14,000 of expenses that should be borne by the Case Control Study will be charged against UCHSC during FYI). In order to facilitate project development and for humanitarian reasons we will continue to support personnel assigned to the Case Control Study. However, this issue is becoming an ongoing management problem with almost daily requests to authorize expenditures that relate to Case Control Study activities. The additional costs for the management of this activity have not yet been built into our budget, and we estimate that these will escalate significantly in FY2. It is our understanding that this practice will continue unless or until API has finalized a contract and funded an account at Fudan University or decides to expense these funds through UCHSC. IT Equipment 5 SH ELL-MCCLU RG-053044 From: Sent: To: Subject: Attach: Matt Todd <ToddM@api.org> Thursday, February 9, 2006 7:06 PM (GMT) benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsortcc@listserve.api.org BHRC: SHS Messages 2006-02-09_shs_new_messages.pdf BHRC Committee Members: Please see Lynn Russo's note below concerning the attached document and her replacement. Matt "Attached is a redraft of the key messages on the Shanghai Health Study. It is meant to help respond to "aggressive" inquiries, that is those where the inquirer knows something about the study but is challenging its "integrity". This is similar to the media inquiry API handled last year. Would you send this to the full distribution list. If there is time at the next meeting we can discuss it. It should also get to Susan Hahn. Also, my replacement will be Trisha Perkins. She is very well qualified for this role, having a strong communications background as well as having worked for a research company. She will be at the next meeting. Would you please add her to the distribution lists and provide access to the website? Thanks. Lynn" Matthew Todd American Petroleum Institute 1220 L Street NW Washington DC 20005 202.682.8319 www.api.org SH ELL-MCCLU RG-053045 SHANGHAI HEALTH STUDY: An independent, scientifically rigorous study The independent investigators conducting the study have full control over the study, including design, research, and all interpretations and conclusions that may be drawn from the data when the study is completed. o The study is a project of Fudan University Medical Center, the University of Colorado Health Sciences Center and Applied Health Sciences, an independent U.S. research firm. o Other key participants in China include the Shanghai Municipal Center for Disease Prevention and Control and the Shanghai Institute for Public Health and Supervision. The studies are designed to withstand rigorous scientific peer review. The study protocols, including data management processes, have met the rigorous requirements of three separate Independent Review Boards; the research program also has the approval of an independent ethical review. o Study protocols, including data management processes, were addressed with the assistance of a Scientific Review Panel and an Ethics Review Panel. Both panels remain available to the investigators throughout the research program. o The independent Scientific Review Panel, composed of international experts in relevant scientific disciplines, endorsed the research protocols following several reviews and revisions. o The independent Ethics Review Panel thoroughly reviewed the study protocols (e.g. informed consent, data management) to ensure they met international standards for human research. The panel consists of bioethicists from the U.S. China and Europe. The independent researchers have been presenting information on the study to a variety of scientific audiences. This is consistent with ensuring the investigators' research independence in conducting the study, analyzing the data, and publishing their conclusions. The goal of the study is to contribute to, and advance, the accepted body of scientific research and knowledge of benzene-induced disease. o The project's purpose is to gain a more refined understanding of the relationship between benzene exposure and associated cancer risks. o The data from a wide range of benzene exposures in Shanghai provides a rare opportunity to conduct meaningful research on the health effects of human exposure to benzene. The study is funded by a number of oil and chemical companies as part of their ongoing, individual product stewardship and safety and health programs. o Beyond advancing knowledge of benzene toxicology, these studies will further assist the contributing companies in their continuing efforts to provide highquality product stewardship and continuous improvement of their risk management programs. o The funding companies are BP, Chevron, ConocoPhillips, ExxonMobil, and Shell Chemical with additional support from Marathon. SH ELL-MCCLU RG-053046 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Monday, February 13,20066: 13 PM (GMT) benzconsort-tc@listserve.api.org benzconsort-oc@listserve.api.org; benzconsort-cc@listserve.api.org; Robin Tillery <tilleryr@api.org> BHRC-TC... SHS CC & DPIME Year-End 2005 Progress Reports CC_Progress_Report_02-2006.pdf; DP_ME_Progress_Report_02-2006.pdf BHRC Technical Committee (-TC) - Attached are year-end 2005 progress reports received from Drs. Wong (CC Study) and Irons (DP & ME Studies); we've not received a year-end report, however, from Dr. Fu / Fudan University (Exposure Assessment), though reasonable coverage of this topic may appear in Dr. Irons' report. Best Regards - Bruce. SH ELL-MCCLU RG-053047 PROGRESS REPORT January 2006 1. ANALYSIS OF DISEASE PROGRESSION FOR APLASTIC ANEMIA, MYELODYSPLASTIC SYNDROME, ACUTE MYELOGENOUS LEUKEMIA AND BENZENE POISONING IN SHANGHAI, CHINA II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS IN SHANGHAI, CHINA III. EXPOSURE ASSESSMENT A MULTICENTER INTERNATIONAL STUDY Molecular Toxicology and Environmental Health Sciences Program Dept. of Pharmaceutical Sciences, School of Pharmacy Department of Pathology, School of Medicine University of Colorado at Denver & Health Sciences Center, Denver, CO School of Public Health, Huashan Hospital, Cancer Hospital, Fudan University Medical Center, Shanghai, China 1 SH ELL-MCCLU RG-053048 EXECUTIVE SUMMARY A. Overall Status of Budget Attached is an official summary of the overall budget for the year ending December 31, 2005. In April 2005, the consortium agreed to a revised budget (Appendix A). Based on this new budget, the overall status of the budget for the second half of the 2005 calendar year is as follows: We spent $1,341,540 compared to a projected budget of $1,883,130, resulting in savings of $541,590 in funds during this period (Table 1). This savings is partly due to cost shifting of contracts from the Fudan budget to the UCHSC budget, and partly due to expenses deferred to the 2006 calendar year. Table 1. Budget Summary (Reporting Period) Budgetedl Expenditures Variance Personnel $236,350 $243,816 ($7,466) Operating Expenses $254,380 $227,940 $26,440 Subcontracts $1,264,180 $747,991 $516,189 Travel $500 $0 $500 Equipment $0 $0 $0 Indirect $127,720 $121,793 $5,927 TOTALS $1,883,130 $1,341,540 $541,590 bThe budgeted amounts are the sum of each category from Jul-05 through Dec-05. Table 2. Budget Summary (Entire Project) Budgeted2 Expenditures Variance Personnel $2,163,606 $2,179,252 ($15,646) Operating Expenses $1,726,386 $1,557,404 $168,982 Subcontracts $7,198,588 $6,621,611 $576,977 Travel $9,993 $9,098 $895 Equipment $1,383,490 $1,383,490 $0 Indirect $1,043,587 $1,002,342 $41,245 TOTALS $13,525,649 $12,753,197 $772,452 2The budgeted amounts are the sum of each category from Dec-Ol through Dec-05. Subcontract Summary (Entire Project) Subcontracts Expenditures (Dec 01 - Dec 05) Fudan University $4,150,117 IPHS $167,577 SMCDC $153,004 EMBSI $1,873,555 Children's Hospital Cincinnati $277,358 2 SH ELL-MCCLU RG-053049 B. Budget Analysis Our projected costs for the remainder of the project are outlined in Table 3. Table 3. Projected Budget (Remainder of Project) Personnel Operating Expenses Subcontracts Travel Equipment Indirect TOTALS Jan1 - Jun 30 Year 2006 $236,350 $235,580 $1,454,051 $500 $0 $122,832 $2,049,913 Jul 1 - Dec 31 Year 2007 ** Year 2006 $245,804 $203,265 $160,780 $150,000 $1,229,168 $609,595 $500 $0 $0 $0 $105,845 $52,849 $1,742,097 $1,015,709 **Post-study costs budgeted only through 6/07. 3 SH ELL-MCCLU RG-053050 Appendix A PersonneL Apr '05 Budget $ Actual 1$ qli'J;i~'n9 *pen.@s.. Apr '05 Budget $ Actual I$ $t:ilii)@jits> Apr '05 Budget $ Actual TraVer " 1$ Apr '05 Budget $ Actual 1$ I5Q(jjPti'1rit> Apr '05 Budget $ Actual 1$ l.i.'.l.d..l.i.'.....F... " Apr'05 Budget $ Actual TOTALS> 1$ Apr '05 Budget $ Actual 1$ Dec-Oil Jun-021 Dec-021 Jun-031 Dec-031 Jun-041 Dec-041 Jun-051 Dec-051 172,140 I $ 224,8831 $ 317,6651 $ 314,7031 $ 230,3281 $ 211,0161 $ 229,260 I $ 235,4371 $ 243,8161 13,131 I $ 94,401 I $ 193,990 I $ 158,850 I $ 162,834 I $ 364,542 I $ 237,258 I $ 104,457 I $ 227,940 I 123,6291 $ 688,452 I $ 213,291 1$ 845,860 I $ 565,870 I $ 1,128,5071 $ 948,6961 $ 1,359,3151 $ 747,991 I -1$ 8,4291$ 2181$ 3461$ 1051$ -1$ -1$ -1$ -I 291,568 I $ 253,578 I $ 354,4961 $ 274,508 I $ 17,000 I $ 192,340 I $ -I $ -I $ -I 47,9221$ 111,4541$ 139,5871$ 122,9021$ 101,4471$ 148,7091$ 120,4081$ 88,1211$ 121,7931 648,3901$ 1,381,1971$ 1,219,2471$ 1,717,1691$ 1,077,5841$ 2,045,1141$ 1,535,6221$ 1,787,3301$ 1,341,5401$ Jun-061 Post-Study thru ITotal thru Post- Dec-06IJun-07 Study 2,849,025 1$ 2,179,248 I $ 1,557,403 1$ 6,621,611 -1$ -I 1$ 9,098 1$ 1,383,490 ..$.... """""""""'''' $ 1,325,"1"12 1$ 1,002,343 1$ 12,753,193 Original Budget Revised Budget $ 14,508,000 $ 18,332,953 (J) Increase $ 3,824,953 I m r r sI : () () r C ;a G) ocI.n c..> oc.n ----lo. 4 I. JCML OPERATIONS A. Progress This progress report is abbreviated because of the detailed discussion of progress given at the annual meeting in November. Case accrual for 2005 numbered 1085 subjects, bringing the total study case accrual to 1816 cases. In addition, over the course of the project to date JCML has diagnosed approximately 40 pro bono cases for individuals, mostly children, who do not qualify for inclusion in our studies. Analysis of study data and manuscript generation continues. II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS A. Molecular Epidemiology Phase 1 The goal of the molecular epidemiology (phase 1) study is to: (a) study retrospective benzene exposure levels vs. blood counts present in worker exam records (2000), and (b) identify candidate factories for the Phase II study. Progress to date has been made in abstracting hematology counts from physical examination data for over 1500 cases from 19 facilities, and exposure assessment has been completed for 17 of these factories. Phase 1 is scheduled for completion in 2006. B. Molecular Epidemiology Phase 2 The goal of the ME study is to recruit 1000 workers at different levels of benzene exposure to ME Phase 2a studies. At present 233 individuals from 3 factories have been recruited and exposure assessment has been completed for all 3 factories. Participation and recruitment of workers and facilities has been hampered by cultural based westernoriented recruitment and informed-consenting strategies that have posed difficulties. These were outlined in detail in the previous progress report. Proposed changes recently endorsed by the Ethics Review Panel are currently under IRE review. If approved, these should facilitate ongoing worker recruitment. ME Phase 2b studies have been discontinued, in part because of problems in recruitment similar to Phase 2a and in part because of our success in recruiting these workers to the DP study. This approach has resulted in characterization of a new form of MDS associated with benzene exposure which was published in 2005. III. EXPOSURE ASSESSMENT The challenges and issues confronting the exposure assessment (EA) team were outlined and discussed in great detail at the annual meeting. Preliminary exposure assessments continue to keep pace with the accelerated recruitment of cases to CC and DP studies. Primary goals for the short term are to purchase additional and replacement equipment necessary for factory inspections, to recruit additional qualified personnel to the EA team and to continue to engage IPHS staff in database validation and the 5 SH ELL-MCCLU RG-053052 integration of database, factory site evaluation and sector information that will be necessary for final EA matrix construction that will take place in the last half of 2006. III. EMERGING CHALLENGES We are encountering difficulties in the continued retention of employees currently working on the project, as well as recruitment of additional staff to supplement efforts such as exposure assessment. In the past 6 months 3 EA team members, 2 members of the JCML laboratory staff, and 1 UCRSC staff member have all resigned. In addition, several highly trained laboratory personnel at JCML as well as several high level UCRSC staff and faculty members are currently exploring alternative employment options. Several of these individuals have expertise and study experience that places them on the critical path for completion of the project. If this attrition continues, the scheduled completion of the study and data analysis will be jeopardized. The explanation for this is readily apparent to those who are familiar with the academic research environment, namely, that salary support for academic research positions is directly linked to funded research projects. At present, there are no closely related projects that utilize the skills of staff dedicated to this project that are in place. Any support or information that consortium members can provide in a timely manner on research opportunities available within the industry or related organizations would be helpful to alleviate this problem. 6 SH ELL-MCCLU RG-053053 Progress Report AML and NHL Case-control Study Activities through December 2005 Prepa red by: Otto Wong, Sc.D. Applied Health Sciences, Inc. 181 Second Avenue, Suite 628 San Mateo, CA 94401 USA Tel: 1 (650) 347-7898 USA Fax: 1 (650) 344-6887 USA ottowong@aol.com ottowong@shmu.edu.cn January 23, 2006 Patient Enrollment The number of participating hospitals has increased to 31 (from 29 in 2004). The majority of participating hospitals are municipal hospitals (17), followed closely by district hospitals (12). The remaining two are occupational hospitals. As of November 2005, approximately 4000 patients have been interviewed. These patients included both cases and controls in the casecontrol study of AML and NHL as well as subjects in the disease progression study. Among the cumulative number of 4000 patients, approximately 3890 questionnaires were entered and verified. In terms of the case-control study of AML and NHL, the case enrollment rates for both AML and NHL patients during the last 6 months appeared to be quite encouraging. According to the numbers provided by the JCML (Dr. Richard Irons), the cumulative numbers of AML and NHL patients are as follows (as of November 2005): 353 acute myeloid leukemia patients 380 lymphoid cancer (WHO) patients 251 "NHL" patients (part of lymphoid cancer above) 1 SH ELL-MCCLU RG-053054  If the current rates of patient enrollment can be maintained through 2006, we will likely end up with the following number of cases by the end of the year (end of data collection): 500-600 acute myeloid leukemia case 500-600 lymphoid cancer (WHO definition) cases 350-400 "NHL" cases (part of lymphoid cancer above) In general, compared to previous years, case identification by the Clinical Coordinators at participating hospitals has been relatively timely and consistent. This is particularly true for AML patients. By comparison, the enrollment of NHL patients still fluctuates from time to time. Most of the NHL patients come from the Shanghai Tumor Hospital. In 2005 the team at Fudan made periodic reminders to the Clinical Coordinators at the Shanghai Tumor Hospital for timely submission of NHL patients. These periodic reminders seem to be working well. Selection of Controls The selection of controls for both AML and NHL patients seemed to be working properly. In 2005, there were only a few minor isolated problems. At a couple of small hospitals with limited number of patients, finding appropriate controls in the right age range, especially when the cases were either very young or very old, could be difficult. There was some confusion as to whether the age matching requirement was 5 or lO years. This point was subsequently clarified: 5 years should be attempted first and, if none available, lO years will be accepted. The participation rate among eligible cases or controls has been extremely high. As of November 2005, only 6 cases or controls refused to participate in the study. We have been able to select two controls for every case. We continue to monitor the distribution of controls by diagnostic category to ensure that there will be no over-representation of any diagnostic category, which in turn may be associated with certain socio-economic class, occupation or lifestyle. The table below shows the distribution of controls by major diagnostic category, which seems to be in agreement with that of the general population of patients in Shanghai. 2 SH ELL-MCCLU RG-053055 Diagnostic category ~ancers Nutritional & metabolic diseases Neurological system diseases ~irculatory system diseases Respiratory system diseases Digestive system diseases Urinary system diseases Musculoskeletal diseases Blood & hematopoietic diseases Mental diseases Percent 13.91% 7.49% 9.75% 12.60% 9.75% 14.86% 10.58% 11.30% 0 0 Please note that, as specified in the protocol, patients with "blood & hematopoietic diseases" or "mental diseases" are not eligible. Exposure Assessment Based on preliminary exposure assessment, a total of 259 patients were either definitely or potentially exposed to benzene, representing an overall benzene exposure rate of 7%. The exposure frequency (7%) is slightly lower than that used for power calculation (10%) in the study design. The distribution of benzene-exposed patients by major industry is as follows: Industry Painting Machine maintenance Rubber Home remodeling Shoe making Printing Percent 32% 20% 14% 13% 12% 9% 3 SH ELL-MCCLU RG-053056  Based on preliminary exposure assessment, some benzene exposure data of study subjects (cases and controls) are presented in the table below: Earliest exposure 1936 Occupations/industries with rubber plank manufacture, highest exposure brush & spray painting Highest maximum exposure 515.7 ppm * Highest minimum exposure 12.1 ppm * Highest typical exposure 161.9 ppm * Longest exposure 40 years * preliminary estimates In addition to the patients identified to have been exposed to benzene, approximately 2800 patients were identified to have been exposed to other substances in a variety of industries. The largest category is farming with potential exposure to agricultural chemicals. Other frequently encountered chemicals are toluene and xylene. We continue to encounter difficulties in accessing the Shanghai Municipal IPHS's historical exposure database. Future arrangements with the Shanghai Municipal IPHS are under negotiation (handled by Dr. Richard Irons). As discussed in our last progress report dated July 24, 2005, several problems in interpreting the data in the Shanghai Municipal IPHS's database were identified; such as large number of zero values in the database and incomplete reporting by the district IPHS to the Shanghai Municipal IPHS. These issues are being addressed by the exposure assessment team under Tom Armstrong's direction. Plans have been underway to develop exposure profiles for 8 to 10 key industries using data from the 5 or 6 most industrialized districts of Shanghai. For example, the exposure assessment team has been working in close collaboration with the Yang Pu District IPHS and has been given access to the exposure records maintained at the local IPHS. The exposure assessment team continues to develop exposure data/estimates using the "sector analysis" approach. The analysis for two commonly encountered industries (shoe and rubber) has been completed. 4 SH ELL-MCCLU RG-053057  Exposure data from other sources are being collected, including published literature. According to Professor Liang, who heads the literature review task, preliminary exposure data for the following occupations/industries have been completed: shoemakers, painters, paint manufacturers, printers, dyers, and rubber workers. These literature data will supplement the Shanghai Municipal IPHS database and district IPHS data in the development of job-exposure matrix (JEM). OA/OC At the beginning of 2005, a full-time person, Zhu Shoumin, was assigned to QNQC, who reported to Zhou Yimei. He was responsible for QNQC of questionnaire data, control selection, data entry and initial exposure assessment. The decision of one person dedicated to QNQC turned out to be a good one. Zhu Shoumin prepared routine monthly QNQC reports, which were shared by all senior investigators. Recently, however, these monthly reports were interrupted because of personnel changes. A new person, Pei Xiaodan, has replaced Zhu Shoumin. I have been reassured by Zhou Yimei that monthly reports will be resumed shortly. A recent QNQC of questionnaires taken between December 2004 and August 2005 indicated that 92.1 % of primary questionnaires sampled for review were "qualified" (i.e., no problems were found) and 98.2% of secondary questionnaires were "qualified." We have discussed with Chen Xiaobao, who is in charge of interviews, ways to further improve the quality of primary questionnaires. The overall data entry error from December 2004 to August 2005 was 2.6%, which is acceptable. In December 2005 I conducted an ad hocQA of 15 matched set of questionnaires (45 questionnaires in total) taken in late November. I identified only 1 minor mistake in these questionnaires (with literally thousands of items/entries). Project Management Communication with the Fudan team in Shanghai remains a high priority item. In addition to email and telephone calls, I made 6 trips to Shanghai in 2005. 5 SH ELL-MCCLU RG-053058  An estimated timeline for the completion of the case-control study is as follows. Based on a discussion with the team in Shanghai, Tom Armstrong and Zhou Yimei, the current projection is that case enrollment will be completed by December 2006. Final diagnoses, control selection, interviews and data entry will most likely be completed by the end of the first quarter of 2007. Exposure assessment of newly enrolled patients (cases and controls) will be conducted in the first and second quarters of 2007. Assuming that both diagnostic and exposure data for all patients will be finalized and available by June 2007, we will be performing epidemiologic analyses of the final data in the third quarter of 2007. To facilitate data transfer/linkage and to develop plans for statistical analyses, however, we will need relatively large and representative samples of exposure estimates and diagnoses of study subjects by mid2006 (see table below). These samples will allow us to develop plans for data transfer/linkage and to test-run analysis programs. Discussions are now underway to obtain these samples on a timely basis. Time ~ctivities July 2006 Samples of exposure estimates (from the Exposure Assessment Team) and diagnoses of study subjects (from JCML) provided to AHS. 3Q & 4Q 2006 Case-control study data management and plans for statistical analyses (based on samples provided). December 2006 End of case enrollment. lQ & 2Q 2007 June 2007 2Q & 3Q 2007 Selection of controls. Interviews, final diagnosis and exposure assessment of last group of patients. Final diagnosis and exposure assessment of all patients completed. Final data editing/auditing. ~nalysis and report preparation. 6 SH ELL-MCCLU RG-053059 From: Sent: To: Subject: Clegg, Patsy M SCC-CHSE-PC <patsy.c1egg@shell.com> Friday, January 7, 2005 2:39 PM (GMT) Beatty, Pat (E-mail) <PatrickBeatty@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Christopher Roythorne (E-mail)<chris.roythorne@uk.bp.com>; Donald M. Burnett PhD (E-mail) <burnetdm@bp.com>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SCC-CF-SS <sc724012@shell.com>; Colletti, Sarah J SCC-CSEA <sarah.colletti@shell.com>; Iannarone, Lauren-old B SCC-CSEA <Lauren.Iannarone-old@shell.com>; Jay Stuller (E-mail) <sjay@chevron.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobil.com>; Richard Herold (E-mail)<heroldra@bp.com>; Valerie Crissey (E-mail) <vcrissey@chevrontexaco.com>; Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Michael Johnston (E-mail) <Mike.dJohnston@ConocoPhillips.com>; Twerdok, Lorraine (E-mail) <twerdokl@api.org> SHS Annual Meeting - Conversation with Dr Fu Hua Team, Shan Tsai and I talked with Dr. Fu Hua today regarding the change of venue for the 2005 SHS Annual Meeting. He was quite amenable to the change. We asked if he would personally notify the other Chinese investigators, let us know when that had been done, and then we would send a letter officially notifying participants. ~gards, Patsy Patsy Clegg Product Steward Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals SH ELL-MCCLU RG-053060 From: Sent: To: Subject: Matt Todd <ToddM@api.org> Wednesday, February 1,20067:15 PM (GMT) benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsortcc@listserve.api.org Shanghai Health Study Update: February 1,2006 Shanghai Health Study Update An nou ncements: Lynn Russo has announced her upcoming retirement from ExxonMobil. On behalf of the Consortium and API, we congratulate you on your retirement, thank you for your efforts and support of the study, and wish you much enjoyment playing golf. Lynn and her replacement plan to attend the February 21st meeting at API. In other staffing news, Camille Priselac has taken a new job with Chevron and Leif Sollid will replace her on the BHRC Communications Committee. A BHRC meeting is scheduled for February 21st. The meeting will take place in Washington DC at API (room 1117). The next BHRC Committee Chair call has been scheduled for March 6th at 2PM EST. The Technical Committee plans to schedule a conference call prior to the February 21st meeting to review the 4th Q05 budget. If you have any announcements that you would like to be posted, please send an email to Matt Todd. Matthew Todd American Petroleum Institute 1220 L Street NW Washington DC 20005 202.682.8319 www.api.org SHELL-MCCLURG-053061 From: Sent: To: Subject: Tsai, Shan SP SHLOIL-SPS Wednesday, September 12, 2001 12:51 PM (GMT) Clegg, Patsy M SCC-CHSE-PC <pmc1egg@Shel1.Com>; Cagen, Stuart Z SCC <szcagen@Shell.Com> RE: Issues regarding 2nd epi position and the hematopathologist posit ion on the SRP. Patsy/Stu, Dr. Delzell is my choice. I would like to know who sent, although inadvertently, the e_mail to her. Shan -----Original Message----From: Clegg, Patsy M SCC-CHSE-PC Sent: Tuesday, September 11,2001 6:29 AM To: Tsai, Shan SP SHLOIL-SPS; Cagen, Stuart Z SCC Subject: FW: Issues regarding 2nd epi position and the hematopathologist posit ion on the SRP. Importance: High Gentlemen, If possible, please give me your preference by the end of the day. If the 2 of you could talk and agree a response, I will respond to Pat. Thanks, Patsy -----Orig inal Message----From: Beatty, Patrick (PWBE) [mailto:PWBE@chevron.com] Sent: Monday, September 10, 2001 5:39 PM To: 'BenzConsort-OC@listserve.api.org'; 'BenzConsort-TC@listserve.api.org' Cc: 'twerdokl@api.org'; 'woodallg@api.org' Subject: Issues regarding 2nd epi position and the hematopathologist posit ion on the SRP. Importance: High Oversight Committee, Epidemiology review of protocol and 2nd Epidemiologist Dr. Linet (NCI) has declined our invitation to serve on the SRP. She indicated that her workload is such that she cannot take on any additional responsibilities. This leaves us with only one epidemiologist at this time, Dr. Mueller from Harvard. The situation is complicated by the fact that Dr. Elizabeth Delzell has informed us that she no longer plans to review and comment on the protocol. She was inadvertently sent an e-mail implying that Dr. Linet had been picked for the SRP and that she, Dr. Delzell, for a variety of reasons would not be asked to serve on the SRP. Shortly thereafter, Dr. Delzell responded that she would no longer participate in the protocol review. I infer from the wording of her e-mail, that she was upset by the note indicating that she would not be asked to be on the SRP. Since Dr. Mueller will be out of the country on 9/27, as it stands now there will be no epidemiologist participating in the protocol review meeting. This leaves us with a number of options. 1.) Try to find another epidemiologist who can serve on the SRP and hope that person can prepare comments on the protocols within two weeks. If not, SH ELL-MCCLU RG-053062 (and I suspect this will be the case) comments at a later date if not too extensive could be incorporated into the protocols without necessitating resubmittal to the IRB process. 2.) Contact Dr. Delzell and attempt to change her mind about the protocol review. This will still involve explaining why we would use her for this but not as a full SRP member. Unfortunately, the e-mail to her did not spell out the concerns about perceptions of conflict of interest due to her funding history by the petrochemical industry. This would still require eventually finding a second epidemiologist for the SRP. If anyone knows Dr. Delzell personally or has an epidemiologist in their company who does it might help to have them help with this effort. 3.) Revisit Dr. Delzell's history and reconsider her as a full SRP member in the hopes that she would consent and finish the protocol review. If she were to still decline, we are back to No.1. My preference is to do 2. Even if she is adamant about no further participation, I think that we should fully explain why she was not invited to join the SRP. I am asking the Oversight Committee to respond ASAP, because we need a ruling on this before we can take option number 2.. I also want the Technical Committee to schedule a Conference call to discuss and propose candidates for the 2nd epidemiologist. I have been given a number of possibilities. Hematopathologist Four of the five companies have agreed with holding off on a search for a hematopathologist for the SRP. ExxonMobil was the one company that did not respond. Instead it will be left to the SRP to decide if they need that expertise. If so it would be one of the two additional positions that the Oversight Committee has agreed to fund at the discretion of the SRP. Thanks Patrick Beatty Patrick W. Beatty Ph.D., D.A.B.T. (510) 242-7037 Office; (510) 242-7022 FAX Staff Toxicologist Petroleum Team Toxicology and Health Risk Assessment CRTC RIC 100 Bldg. 24-1125 E-mail: pwbe@chevron.com SH ELL-MCCLU RG-053063 From: Sent: To: Subject: Attach: Matt Todd <ToddM@api.org> Tuesday, February 14,20064:23 PM (GMT) benzconsort-oc@listserve.api.org; benzconsort-tc@listserve.api.org; benzconsortcc@listserve.api.org BHRC: Feb 21 Meeting - Draft Agenda 2006-02-21_bhrc_meeting_agenda_draft. doc BHRC Committee Members: Attached is the draft agenda for the upcoming 2.21.2006 meeting. Please note the "SHS Timeline" PDF is embedded within the document. Please contact me with any questions you may have. Dinner Information for Monday, February 201h~ Where: Time: Location: Website: Primi Piatti (private room) 6:30 PM EST 2013 I Street NW, Washington DC (Eye Street, as in the letter I) http://www.primipiatti.com/ Dinner Attendee List: Lynn Russo Patsy Clegg Jennifer Galvin Stephen Bowes Shan Tsai Michael Johnston Zach Wong Matt Todd Russ White Mark Fitzsimmons John Wagner Stuart Cagen Please contact me if you want to attend the dinner, but are not on the list...or vice versa. Regards, Matt Matthew Todd American Petroleum Institute 1220 L Street NW Washington DC 20005 202.682.8319 www.api.org SH ELL-MCCLU RG-053064 Benzene Health Research Consortium Meeting February 21, 2006 American Petroleum Institute 1220 L Street NW, Washington, DC Conf. Room 1117 Agenda Conference call information: Dial-in number: 866.443.0059 Code: 2026828319# 7:45 AM 8:00 8:10 8:15 8:25 10:00 10:15 Noon 12:30 1:30 PM 3:45 4:00 Continental Breakfast Welcome and Introductions Anti-Trust Establish Quorum Note Taker Review Successful closure of study planning Where are we and how did we get here? Key Issues What does closure look like? Develop plan using issues and time line (attached below), including key events: o 06 Meeting o 07Meeting o "Closing" Ceremony o Benzene sium Break Successful closure of cont'd Lunch Successful closure of study planning, cont'd Topics as time permits Technical Committee Update 05 Financial Review U of Colorado Financial Review Closure Plan discussion with API P. J. P. Clegg P. Clegg 15 minutes 20 minutes 20 minutes P. API J. Galvin S. Cagen P. P. SH ELL-MCCLU RG-053065 I:.,,~ Timeline.pdf SH ELL-MCCLU RG-053066 From: Sent: To: Cc: Subject: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Friday, February 24,2006 12:01 PM (GMT) Jerry Rice (E-mail)<Jmricewas@ao1.com> Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Michael Johnston <Mike. dJohnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Anita Balaraman (E-mail) <anita.balaraman@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Jennifer Galvin (E-mail)<jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SHLOIL-SHOIL-SHS <sc724012@shell.com>; Colletti, Sarah J SCC-DCSI14 <sc192550@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobi1.com>; Richard Herold (E-mail) <heroldra@bp.com>; John Wagner (E-mail) <wagner@api.org>; Mark Fitzsimmons (E-mail)<mfitzsim@steptoe.com> Thank You from the Shanghai Health Study Sponsors Jerry, Thank you very much for meeting with the sponsors of the Shanhai Health Study this week. Your contributions to the planning for bringing the study to successful closure are valued. We look forward to continuing to work with you and your team. ~gards, Patsy Patsy Clegg Product Steward Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals SH ELL-MCCLU RG-053067 From: Sent: To: Subject: Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com> Friday, February 24,2006 12:01 PM (GMT) Matthew Todd (E-mail) <toddm@api.org>; whiter@api.org; Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Burnett, Don (E-mail) <burnetdm@bp.com>; Michael Johnston <Mike.d.Johnston@ConocoPhillips.com>; Zach Wong (E-mail) <ZachWong@chevrontexaco.com>; Anita Balaraman (E-mail) <anita.balaraman@chevrontexaco.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org>; Jennifer Galvin (E-mail)<jennifer.b.galvin@conocophillips.com>; Matthew A Hughes (E-mail) <hughm7@BP.com>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Tsai, Shan P SHLOIL-SHS <st196949@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Cagen, Stuart Z SHLOIL-SHOIL-SHS <sc724012@shell.com>; Colletti, Sarah J SCC-DCSI14 <sc192550@shell.com>; Lynn Russo (E-mail) <lynn.b.russo@exxonmobi1.com>; Myron Harrison (E-mail) <myron.c.harrison@exxonmobil.com>; Richard Herold (E-mail)<heroldra@bp.com>; John Wagner (E-mail) <wagner@api.org>; Mark Fitzsimmons (E-mail) <mfitzsim@steptoe.com>; Bruce M. Jarnot (E-mail) <jarnotb@api.org> Shanghai Health Study Planning Meetings - Thanks! BHRC Team; I want to extend a personal thank you for your participation in the Shanghai Health Study planning meeting that we had this week. As we approach the end of the study, the planning that we have initiated is critical to bringing the project to a successful closure. Your contributions are valued. I look forward to continuing to work with you. ~gards, Patsy Patsy Clegg Product Steward Shell Chemical LP One Shell Plaza, 910 Louisiana, Houston, TX 77002-4916 Tel: +1 713 241 2521 Fax: 3325 Email: patsy.clegg@shell.com Internet: http://www.shell.com/chemicals SH ELL-MCCLU RG-053068 From: Sent: To: Cc: Subject: lynn. b .russo@exxonmobil.com Friday, February 24,2006 1:23 PM (GMT) Clegg, Patsy M SCC-DCSI22 <patsy.c1egg@shell.com>; Brian Doll (E-mail) <brian.e.doll@exxonmobi1.com>; Jennifer Galvin (E-mail) <jennifer.b.galvin@conocophillips.com>; Mark Fitzsimmons (E-mail) <mfitzsim@steptoe.com>; Michael Johnston <Mike.d.Johnston@conocophillips.com>; Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com>; Stephen Bowes (E-mail) <stephen.m.bowes@exxonmobi1.com>; Matthew Todd (E-mail) <toddm@api.org>; whiter@api.org; Zach Wong (E-mail)<ZachWong@chevrontexaco.com> Bruce M. Jamot (E-mail) <jamotb@api.org>; Michael Bird (E-mail) <michae1.g.bird@exxonmobi1.com>; Cagen, Stuart Z SHLOIL-SHOIL-SHS <stuart.cagen@shell.com>; bumetdm@bp.com Thanks for dinner. Thank you all for dinner, your thoughtful gift, the card (turns out the pen wasn't so bad but the writing is a challenge to interpret) and all your best wishes. I really enjoyed this project including all the rough spots and challenges--all the wonderful people made it work. Lynn SH ELL-MCCLU RG-053069 From: Sent: To: Cc: Subject: Bruce Jarnot <jarnotb@api.org> Wednesday, March 22, 2006 6: 11 PM (GMT) benzconsort-tc@listserve.api.org OttoWong@aol.com; benzconsort-oc@listserve.api.org Regrets... BHRC-TCIPI Call *Cancelled* with Otto Wong - Thurs 3123 Benzene Health Research Consortium - Technical Committee (BHRC-TC) With regrets... tomorrow's scheduled "PI Call" with Dr. Wong has been cancelled due to significant BHRC-TC member unavailability for this periodic update. Best Regards - Bruce. From: Bruce Jarnot Sent: Friday, March 17,2006 11:40 AM To: 'benzconsort-tc@listserve.api.org' Cc: 'OttoWong@aol.com'; 'benzconsort-oc@listserve.api.org' Subject: BHRC-TC. .. PI Call wi Otto Wong - Thurs 3/23, 11am EST Importance: High Benzene Health Research Consortium - Technical Committee (BHRC-TC) Dr. Wong kindly offered to restart our 2006 PI Conference Call schedule, by meeting with the Technical Committee next week. Note the alternate PIN code vs. previous BHRC-TC calls: Date: Thursday, March 23rd Time: 11 :OOam EST (10:00am Central, 8:00am Pacific) Phone: 770-765-9147 (toll free: 866-443-0059) PIN Code: 202-682-8473# (Bruce's phone number) Please reply if you cannot join next week's call. Best Regards - Bruce. From: OttoWong@aol.com [mailto:OttoWong@aol.com] Sent: Friday, March 17,2006 11:09 AM To: Bruce Jarnot Subject: Call with sponsors Dear Bruce: When we talked last week, we thought it would be a good idea to resume my periodic conference calls with members of the technical and oversight committees. We tentatively set our next call at 8 AM (Pacific time) on March 23. I have not heard from you since. Is the call still on? Please advise. SH ELL-MCCLU RG-053070 Regards, Otto ******** Otto Wong, ScD., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, Tulane University, New Orleans, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Associate Editor, Occupational and Environmental Medicine Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 Email: OttoWong@aol.com SHELL-MCCLURG-053071 From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Monday, November 10, 2003 7:35 PM (GMT) benzconsort-tc@listserve.api.org Matt Todd <ToddM@api.org> Shanghai TC... draft minutes from 11/07/03 conf call Minutes BHRC-TC 07 Nov 2003.doc Benzene Health Research Consortium - Technical Committee (BHRC-TC) Attached are draft minutes from the BHRC-TC Conference Call on Nov 07, 2003. By copy to Matt, please post to the SHS website/Tech Committee page ... thanks! Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-053072 Benzene Health Research Consortium Draft Technical Committee Meeting Minutes November 7,2003 Conference Call Participants 1. Patrick Beatty (ChevronTexaco) 2. Michael Bird (ExxonMobil) 3. Steve Bowes (ExxonMobil) 4. Bill Broddle (ConocoPhillips) 5. Stuart Cagen (Shell) 6. Mark Fitzsimmons (S&J) 7. Bruce Jarnot (API) General Items Antitrust review and roll-call were completed Note from Richard: 100 case referrals from hospitals to date, including some unusual hematopoetic diseases 3Q03 Financials Kudos to API on quarterly package, especially retrospective financials I.G"Qrn2argq~: to prepare a "crib sheet", briefly explaining: o Basis of budget parse on each contract o Basis of budget extrapolation 2005 ~ 2007 Endorsement of SRP Recommendations & Contingency Fund ~GtJgm;B~(riqktg(q~rt: to carry BHRC -TC recommendation to -DC meeting: o Add sufficient urinary SPMA analyses to allow read-across to previous ME studies o Add HIV testing of Controls in CC study o Reduce scale of ME study to 1000 cases To achieve necessary cost savings, while maintaining scientific integrity o Recommendation subject to SRP approval DRAFT Rev 10131103 Page 1 of 2 SH ELL-MCCLU RG-053073 Benzene Health Research Consortium Draft Technical Committee Meeting Minutes $150K needed (Dr. Irons' revised estimate) to fund the added testing: o $1 OOK for HIV in CC; needs new "informed consent" form includes assay cost, increased compensation, lab overhead o $50K for urinary SPMA in ME (800 determinations) pre-/post-shift testing in 300 individuals, plus validation With a concomitant cost reduction in ME study Target: 1000 workers (still seen as a "world class" study) Estimated to achieve $750K-$1 MM savings Target $500K set-aside for contingency fund I.G"Qrn2argq~: check with Richard (before Monday PM) to see what he needs for T&E budget - new proposal, or adjusted timing of original estimate (Done ... $1.41 MM; info emailed to BHRC-TC & -DC 11/10103) Next Meeting No meeting or conference call scheduled at this time DRAFT Rev 10131103 Page 20f2 SH ELL-MCCLU RG-053074 From: Sent: To: Cc: Subject: Bruce Jamot <jamotb@api.org> Monday, November 10,20035:22 PM (GMT) benzconsort-tc@listserve.api.org benzconsort-oc@listserve.api.org BHRC-TC Contracting... Important update info from Richard Irons BHRC Technical Committee - Information from Dr. Richard Irons, subsequent to the BHRC-TC Conference Call discussion this past Friday (Nov 07)... UCHSC Grant 1) Budget "caps" for UCHSC subcontracts were set based on the original pre-SRP program budget, and some of these have nearly run out. Even though UCHSC has -$2MM in the bank, these subcontracts cannot be easily modified without formal documentation of the new approved UCHSC budget. 2) Action: UCHSC needs a formal letter from API, stating the revised/increased total UCHSC budget and anticipated payment schedule. UCHSC Interest 1) UCHSC will refund interest earned on Dr. Irons on-deposit grant funds, if the Consortium writes to state that it is standard policy to collect all interest on deposited funds. 2) UCHSC may balk at this, however, because of the non-standard reduced indirect/overhead charges that were negotiated on this grant. T&E Budget 1) Dr. Irons' current budget (Oct 272003) for T&E, extended 1.5years through 2Q07, totals $1.41 MM 2) Richard claims that this T&E budget was revised from $1.23MM (Jan 2001) to $1.59MM (Dec 2001), during the overall program adjustment to incorporate SRP research add-ons. (I have not found this documentation) 3) Thus the new $1.41 MM budget represents either a 12% savings (over $1.59MM), or a 11 % increase (over $1.23MM) T&E Contract 1) Richard will accept either a "travel advance" contract, as current, or a "per-diem advance" contract at NIH's Shanghai rate (-$100/person/day). He cannot afford to personally advance travel expenses for 8-12 UCHSC scientists, and states that the current contract saves the Consortium considerable money vs. the per-diem approach. 2) Richard is submitting a copy of his monthly "daily ledger" to API for review. API accounting feels this may provide needed documentation to allow continued "travel advance" contracting for Irons T&E expenses. I personally believe this to be true, and "keep it the same" to be the best course of action for the Consortium with regard to the T&E contract. Best Regards - Bruce. ***** Bruce M. Jarnot, Ph.D., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-053075 From: Sent: To: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Wednesday, October 8,2003 7:42 PM (GMT) benzene-srp@listserve.api.org; benzconsort-tc@listserve.api.org "Leukemia risk from low level benzene exposure" article in Epidemiology (Sep 2003) Glass-Epidemiology-2003 pg1.pdf Shanghai Health Study Technical Committee, Science Review Panel & API Benzene Task Force ... Courtesy of Lorraine Twerdok, attached is the first page (copyright deference) of an article by Deborah Glass et al. on "Leukemia risk from low level benzene exposure" (Epidemiology, Sep 2003; 14:569-577) which reports on a nested casecontrol study of Iympho-hematopoietic cancers within the the Australian petroleum industry cohort of benzene-exposed workers. Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-053076 From: Sent: To: Subject: Attach: Paula Podhasky <Podhaskyp@api.org> Thursday, September 4,20032:20 PM (GMT) BenzConsort-OC@listserve.api.org; BenzConsort-CC@listserve.api.org; BenzConsortTC@listserve.api.org BHRC Recruitment Committee Minutes 8272003 Recruitment minutes. doc Attached for review are draft minutes from the Recruitment Committee Meeting at Asilomar. Paula P. SH ELL-MCCLU RG-053077 Draft 912/2003 BHRC Recruitment Committee Meeting Minutes August 27,2003 Participants: Don Burnett, BP Patsy Clegg, Shell Brian Doll, Exxon Mobil Mike Johnson, Conoco Phillips Shan Tsai, Shell Lynn Russo, Exxon Mobil Bill Broddle, Conoco Phillips Paula Podhasky, API Matt Todd, API Lorraine Twerdok, API John Wagner, API AGENDA 1. Review Previous Recruitment Efforts 2. < Full Share Enticements (e.g. patronage for philanthropic organizations) 3. Other Items Review Previous Recruitment Efforts Participants were asked to review recruitment tier sheets on the SHS website and consider which companies to approach with less than full share membership option http://www.shanghaihealthstudy.org/ Investigate Chinese sponsorship Define sponsorship expectations and privileges for NGOs and government agencies. < Full Share Enticements Expectations: o 200K minimum o Sponsor sign contract Privileges: Need to clearly establish privileges of the less than full share sponsor. Options available include o Level of participation (i.e. observer only at meetings, participant at meetings, voting privileges.) o Identified as sponsor on publications, posters and meeting presentations o Website access o Study updates o Meeting attendance: committee and annual o Financial reports See Table below SH ELL-MCCLU RG-053078 Draft 912/2003 Action Item: Check with your legal department on whether company wants to be acknowledged as a sponsor in SHS papers and presentations. (all representatives) (John Wagner) Action Item: Contact Pis to confirm how sponsors would be acknowledged in publications. (Shan Tsai and Bill Braddle) Proposed privileges by sponsorship level Privileges Oversight Committee Technical Committee Budget Committee Communications Committee SRP/ERP Study Updates Website access Financial Reports Identified as sponsor on publications, posters and meeting presentations Annual Meeting $200,000 X ...; X Observer X ...; To general part, but not committees ...; TBD $500,000 Observer Participant Observer Participant X ...; To general part, but not committees ...; TBD Observer Observer Action Item: Schedule Recruitment Committee meeting for September/October 2003 in Chicago. (Patsy/ Paula) SH ELL-MCCLU RG-053079 From: Sent: To: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Monday, June 9,20034:46 PM (GMT) benzconsort-tc@listserve.api.org; Cagen, Stuart Z SCC <szcagen@Shel1.Com> FYI...BHRC-OC briefing addendum sent to exec committee Attach E-China Benzene Paper 6-19-03 mtg.doc Fyl. ... -----Original Message----From: Bruce Jarnot Sent: Monday, June 09, 2003 8:56 AM To: 'benzconsort-oc@listserve.apLorg' Cc: Matt Todd; Paula Podhasky Subject: Please Read ... BHRC-OC briefing addendum sent to exec committee Importance: High Benzene Health Research Consortium Oversight Committee - PLEASE READ the attached final version of the Executive Briefing Addendum, as Red has significantly changed the focus and content of the document... Most significantly, it does not pose a request to API for funding or underwriting. Even though the question is not explicitly stated, it has been posed at earlier meetings and should surface. Regards - Bruce. -----Original Message----From: Bruce Jarnot Sent: Monday, June 09, 2003 8:26 AM To: 'benzconsort-oc@listserve.apLorg' Cc: Matt Todd; Paula Podhasky Subject: BHRC-OC... briefing addendum sent to exec committee Benzene Health Research Consortium Oversight Committee - The attached briefing addendum was sent to API's Executive Committee on Friday, June 6th ... Best Regards - Bruce. ***** Bruce M. Jarnot, PhD., DABT American Petroleum Institute Regulatory and Scientific Affairs 1220 L Street, NW (Room 1025) Washington, DC 20005-4070 phone: (202) 682-8473 fax: -8031 email: jarnotb@api.org SH ELL-MCCLU RG-053080 Attachment E For Discussion Action By Subscribing Companies API Executive Committee June 19, 2003 China Benzene/Shanghai Heath Study Issue: Absent significant slippage in the project timetable; the participating companies should determine and communicate their decision, if they plan not to go forward with the project, before the group convenes at its Annual Meeting in California at the end of August. Background: At its March 18, 2003 meeting, the Executive Committee discussed funding and management of the Shanghai Health Study. The March Executive Committee briefing paper is at Attachment E-1 for reference. At that time, questions were raised about the Benzene Health Research Consortium project's scope and the importance of assuring that the Consortium is adequately managing costs. Discussion: Project/Scope. Member company participation and funding of this study was conditional on developing the highestquality science with full consideration of ethical issues involved in a study of exposed human subjects. To that end, the Consortium formed the independent Scientific Review Panel (SRP) and Ethics Review Panel (ERP) of distinguished scientific experts from a variety of fields to guide the study (membership lists attached). Improvements were recommended by the panels, reviewed by company scientific experts, and approved by the consortium members' Oversight Committee. These improvements increased cost beyond the original estimate of $19.8MM to $22.8MM but did not alter the scope of the project. These changes were incorporated at the outset of the project and included: Increased number of control subjects in the epidemiology portion of the study; and Consistency of exposure assessment methods between all segments of the study. Accordingly, the only increases in budget were to enhance the quality of study results. The SRP and ERP annually review the study with the Principal Investigators, and may propose changes. The consortium members Oversight Committee must, however, review and approve any recommended changes with a budgetary impact. Any changes the Consortium might find that could be recommended to maintain the scientific or ethical integrity of the study would be given strong consideration by the Oversight Committee of the participating companies. Consortium Management of Funds. API, as contract administrator, manages the study on a day-to-day basis as part of API's self-supporting operations; the Consortium Technical Committee oversees financial tracking relative to project milestones. Both study progress and spending have slowed due to unforeseen events, such as restrictions imposed following 9/11, which delayed entry of Chinese scientists into the US for training at the University of Colorado. Most recently, SARS has delayed the enrollment of cases. At this time, however, the study is on the $22.8 MM budget track and spending to date is consistent with work effort and work progress. The Oversight Committee and API staff continue to closely monitor spending to insure the study continues within its budget. Given the SARS impacts, some slippage in the near term timetable may occur. Near Term Activities. An annual meting of the project participants, including the Chinese officials involved, is scheduled for the end of August in California. If the companies in the consortium conclude they are to end the project, they may wish to communicate such before the August conference convenes. The current level of funding would be sufficient to do the epidemiological (epi) study portion of the overall project, but the Chinese may well lose interest, since they are very committed to the other two projects. The epi study alone would not yield the desired benefits of the overall project for the companies. An update will be provided on efforts to gain additional participation/funding from companies that will benefit from the study results. Recently, feedback has been received that both Dow and Sunoco have declined to participate. Recommendation: If the participating companies elect to continue the project, direct API and the participants to communicate at every opportunity the importance and necessity of minimizing costs, while continuing to search for additional funding. If the study is not to be fully funded, API will await word from the participating companies as to their SH ELL-MCCLU RG-053081 preferences for action. If intent is to terminate, it may be best to communicate such to the Chinese officials and the members of the SRP and ERP prior to the California annual meeting of the project. SH ELL-MCCLU RG-053082 Shanghai Health Study - Independent Expert Review Panels I. ERP - Ethics Review Panel Dr. Baruch Brody (Chair) Baylor College of Medicine Dr. Juhana Idanpaan-Heikkila World Health Organization Dr. Zong-Liang Xu Fudan University II. SRP - Scientific Review Panel Dr. Richard Albertini Genetic Toxicology University of Vermont Dr. Harvey Checkoway Epidemiology University of Washington Dr. John Cherrie Industrial Hygiene Aberdeen University Dr. Helmut Greim General Toxicology University of Munich Dr. Robert Herrick Industrial Hygiene Harvard University Dr. Li Guilan Genetic Toxicology Chinese Academy of Preventive Medicine Dr. Richard Larson Hematology University of Chicago Dr. Mark Minden Hematology University of Toronto Dr. Nancy Mueller Epidemiology Harvard University Dr. Jerry Rice (Chair) General Toxicology Retired Chair, IARC Dr. Howard Rockette Statistics University of Pittsburgh Attachment SH ELL-MCCLU RG-053083 Attachment E-1 API Executive Committee March 18, 2003 China Benzene Study Update Issue: The Benzene Health Research Consortium is seeking guidance on options to address a shortfall in funding the industry-sponsored Shanghai Health Study (SHS). A five-year project designed to investigate the potential health effects of benzene, the study sponsors have secured $16.5 of the $22.8 million required to carry it to completion. Although preparations for the research have begun, this $6.3 million funding gap will need to be closed through commitments in the near term, or the project will be terminated prematurely in 2004. Background: Continued concern about the potential health effects of benzene is reflected by two recent studies that suggest a link between benzene exposure and certain cancers not previously associated with the chemical. The Consortium is sponsoring a five-year study in Shanghai, China, which could significantly decrease the uncertainty surrounding the issue. A joint investigation primarily managed by the University of Colorado and Fudan University, the SHS includes protocols developed with the assistance of a l2-member international scientific review panel and Chinese, European and American bio-ethics specialists. It also has strong support and active participation from Chinese universities, hospitals and regulatory agencies. The United States EPA has expressed interest in participation. The quality of Shanghai's occupational benzene exposure records offers an unprecedented opportunity, and perhaps the last of its kind, to conduct this type of study on the relationship between benzene exposure and the risk of certain blood diseases. The SHS will enhance industry's product stewardship, while providing the scientific, regulatory and business communities with better information on benzene. Project Status: Three inter-related studies are underway: (1) a Case-Control Epidemiology study; (2) a Disease Progression Study; and (3) a Molecular Epidemiology Study. Laboratory construction, technical training and exposure assessments are nearing completion and individual case acceptance will begin in spring, 2003. Legal and public affairs expertise has been retained to facilitate Consortium activities. Funding Status: Current funding for the program is projected to run out during the first quarter of 2004. Five companies (BP, ChevronTexaco, ConocoPhillips, ExxonMobil and Shell Chemical Company) have contributed $16.5 million. While the study was initiated with a modest shortfall, subsequent protocol enhancements recommended by independent scientific and ethics review panels led to the final budget of $22.8 million. The Consortium has made presentations to ACC, ARPEL, CONCAWE, IPIECA, and NPRA; held focused discussions with Dow Chemical Company, Marathon Ashland, and Sunoco, and approached AGIP-ENI, ARPEL, BASF, Citgo, Dupont, Lyondell-Equistar, Petronas, Statoil, and TotalFinaElf. To date, none of these entities has agreed to join the Consortium and contribute funds, although CEO-level calls will soon be made to Dow, Sunoco and TotalFinaElf. Implications: The Consortium Technical Committee studied the impacts of a funding shortfall and determined that, at best, only one of the three studies could be completed with current funds. The reality, however, is that an unclosed gap would result in loss of Chinese collaboration, in which case none of the studies would likely be completed. Aside from lost opportunity, this situation could have external relations and legal ramifications. Since the study will be of benefit to the entire industry, the Consortium is requesting that API leadership consider whether API can provide support to eliminate the current shortfall. In that regard, should API underwrite the remaining shortfall while recruitment efforts continue, with the expectation of being repaid any subsequent shortfall, in full or in part, by the Consortium? While the Executive Committee can defer action on this issue until its June meeting, a funding decision will need to be made at that time, or efforts should likely get underway to wind down the project. SH ELL-MCCLU RG-053084