Document qkgwZOv8V1M6YwnDJqxzMaK3k

PROPOSAL to the R.J.Reynolds Tobacco Company Winston-Salem, N.C, 1. Review EPA Report of May 1990 on ETS 2, Organize and Conduct 2 Workshops submitted by Biomedical & Environmental Consults, Inc. Richland, WA November 11, 1990 eaftS. ! t't " ! l i .i i \ Ik "I i\ f- i = !r :i !\ < :: : I, ! i I' : '! 1 '' I i 1 I' Ei m: Ji TECHNICAL PROPOSAL General : . Biomedical & Environmental Consultants, Inc., hereafter referred to as BEG, proposes that the R.J.Reynolds Tobacco Company, hereafter referred to as RJR, fund, in stages, the projects outlined in this tech nical proposal. Funding levels for Phase 1 of the projects are outlined in the Business Proposal which, together with the Technical Proposal, comprises the Proposal of BEC to RJR. Funding levels for subsequent project phases will be negotiated between RJR and BEC and added as Amendments to the Business Proposal, : ; ; . . The Office of BEC, hereafter referred to as BECO, located at 312 Saint j Street, Richland, WA, will organize and administer the projects. , :i . BECO will seek a commitment in the form of a signed statement from individuals collaborating on the projects, not to disclose information de- , veloped in the course of this work to any third party unrelated to RJR without prior written approval by RJR. i ; ; i i! .-- BECO will sumbit to RJR Informal written monthly status reports. : ' j . BEC members collaborating on these projects are independent consultants 1 and not employees of BEC. BECO will exert its best efforts and exercise ' reasonable care in the exercise of Its business but shall not be held . ; liable for acts of commission or omission by its members and other project participants, or any consequences thereof. i Tasks of Phase 1 I, Review and Commissioning Committee BECO will organize a Review and Commissioning Committee (RCC). The RCC initially will consist of several BEC members. Subsequently, qualified individuals notbelonging to BEC may be added. The RCC may comprise up to 12 members. The tasks of the RGG will be . to review, analyze, and develop a written response, through BECO, to the : EPA review draft "Health Effects of Passive Smokings Assessment of Lung . , ; Cancer in Adults and Respiratory Disorders in Children" (EPA/600/6-9Q/006A, ; May 1990). The objective of this review is to examine the scientific ' : validity of data selection, analysis, and interpretation in the EPA report and the conclusions based thereon. BEC proposes to hold a 2-day meeting of RCC members in Week 8 of the contract to discuss findings, to coordinate the response in the form of a report to RJR, and to decide the format of . ; the report to RJR. Organizational and technical tasks relevant to planning g the workshops on meta analysis and low-dose extrapolation, to be conducted ; co in Phase 2, will also be discussed. ` :2 ' : -- I ! <Tt ' ' ' <s> : . ip* -l - .. :, ; - - -i "E1-M i urn 1 n ra n 1 - RJR expects receipt of the response within 2 months after the signing of the contract between RJR and BEG. . to supervise and administer, through BECO, RJR-authorized and RJR- ; ; financed projects and to commission to other committees or entities the performance of certain project tasks when appropriate. \ ij . to organize and conduct, through BECO, workshops on the following sub jects i ' (1) meta analysis (2) low-dose extrapolation 'i The workshops will be held in Phase 2. ' . to organize, through BECO, a Meta Analysis Review Committee (MARC). ; MARC will consist of recognized meta analysis experts recommended by' i BEC and RJR. It is expected that MARC members will participate in the meta analysis workshop. MARC will critically examine meta analysis issues and submit a report on its findings to the RCC for review. A : copy of the report with RCC review comments, if any, will be sent to j RJR. J E !i The time table for establing MARC depends on the availability of recog- 1 nized meta analysis experts, a factor beyond the control of the RCC and ' BEC, and on appropriate funding from RJR. Best efforts will be made to ; establish MARC as expeditiously as possible. ' . to identify RRC members prepared to discuss issues pertinent to ETS risk assessment in regulatory, administrative, or legislative forums. ' These discussions will take place in Phase 2 or thereafter, > j Tasks of Phase 2 I. Meta Analysis Workshop The RCC, through BECO, will organize and conduct a workshop on meta ana- ; lysis. The objective of the workshop will be to critically examine ad- | vantages and limitations of this technique, and its appropriateness in; i certain applications. MARC members are expected to attend this workshop, | Other recognized experts in this field may also be invited to attend. A ; report, summarizing the salient points of the workshop discussions, will ; be prepared and submitted to RJR. Dates and location of the workshop, number of participants, cost estimates, and other details will be determined at a later date and submitted to RJR ; in the form of an Amendment to this Proposal. ;! 50803 7605 .-- rr ;. II. Low-Dose Extrapolation Workshop ... ; ;i The BCG, through BECO, will organize and conduct a workshop on low-dose extrapolation. The objective of the workshop will be to discuss and ex- ; amine problems with low-dose extrapolation, used to perform risk assess ment on environmental tobacco smoke (ETS) and carcinogenesis. In addi- tion to qualified BEG members, other recognized experts may also be in vited to attend. A report, summarizing the salient points of the work shop discussions, will be prepared and submitted to RJR. ; ;; Dates and location of the workshop, number of participants, cost estimates, and other details will be determined at a later date and submitted to RJR : in the form of an Amendment to this Proposal. - III. The two workshops will be scheduled to allow qualified individuals to ' participate in both meetings if they so desire. f ' !: Forum Discussions i- t. ;; :: After the Week-8 meeting at the Battelle Seattle Conference Center, BEC ; expects to be in a position to identify RGC members who will be available to discuss issues pertinent to ETS risk assessment in regulatory, admin istrative, or legislative forums 2 - k days per month throughout 1991. :: Schedules, fees, and other details will have to be negotiated directly between the individual RGC members and RJR. ' 50803 7606 1 r -.3 PROPOSED SCHEDULE Phase 1 Contract Time Action I. Response to EPA Report Week 1 , Execute contract (RJR & BEG) . Send by Federal Express, or similar means, EPA draft and RJR responses to RCC members (RJR) ! ' Week 2 through? . Review and analyze EPA report and prepare written critique (RCC members) . ; Week ? Week 8 . Submit outline of critique to BECO (RCC members) ` 11 . 2-day meeting at Battelle Seattle Conference Center to discuss (l) EPA draft and RCC member responses and (2 ) organizational and technical tasks relevant to planning the workshops on meta analysis and low-dose extrapolation Week 8 + 9 Week 10 . Fine-tune individual responses by authors and review of : final response to RJR (RCC members) ; ;; . Submit coordinated RCC response to RJR (BECO) ' ' II. Planning Workshops : ;1 Week 2 through 11 . Provide input and recommendations for mechanisms by which RCC might develop workshops on the subjects of meta ana lysis and low-dose extrapolation (RCC) Week 12 . Submit workshop plans to RJR for review (BECO). The workshops, if authorized and funded by RJR, will be held in Phase 2 ' III, Forum Discussions .nn.ni.nr. - i-nr " ; 1 .! | | Not later than Week 8 ; ,i . Identify RCC members available to discuss issues perti nent to ETS risk assessment in regulatory, administrative, or legislative forums (BEC), The discussions will take place in Phase 2 IV. Establishing MARC i Week 3 through 12..Define objectives for MARC} recruit suitable membersj organize and establish MARG (BEC) -4 - Phase Z Contract Time Action I, Meta -Analysis Workshop Month 3 + 4 . Plan, schedule, and organize workshops invite participants End of Month 4 . Hold workshop Month 5 + 6 , Prepare report End of Month 6 . Submit report to RJB II. Low-Pose Extrapolation Workshop .; ; :i BEC proposes a schedule similar to that for the meta analysis workshop. Scheduling of the two workshops will be coordinated to allow qualified . individuals to participate in both meetings if they so desire. : .. Details of Phase 2 projects, such as dates and duration of workshops, number of participants, etc., will be provided with a cost estimate as an Amendment to this Proposal when more precise information becomes available. ' Dr. Alfred P. Wehner, President : Biomedical & Environmental Consuiltai niti s- ,I. nc. . -5- -- r U1 !Q : co <3 !W !,, -j i : <n : , <s 00 li S' P e m -- S. BUSINESS PROPOSAL Biomedical & Environmental Consultants, hereafter referred to as BEC, pro poses to conduct work for the R.J.Reynolds Tobacco Company, hereafter re ferred to as RJR, in Phase 1 of the projects as described in the Technical Proposal, for an estimated total dollar amount not to exceed $211,887. i .! A . cost breakdown is included as part of this Business Proposal :: Ei , BEC proposes to establish a businessaccount at the Richland branch : ' of the Seattle First National Bank specifically for the RJR projects , ; . RJR agrees to maintainwithin contract limitations, a balance in that account that is sufficient for BEC to pay anticipated authorized project expenses i . BEC will submit monthly to RJR an account of expenses . If a cost overrun appears to develop, BEC will contact RJR at the earliest indication thereof to discuss appropriate steps to resolve potential problems ; , BEC will submit to RJR Amendments tothis Business Proposal before the start of work planned for Phase 2 of the projects : . In case of cancellation of this Contract by RJR, RJR agrees to pay for financial commitments made by BEG before cancellation in pursuit of its contractual obligations to RJR ; '1 *: 6 ih": ife i! BUDGET ESTIMATE Phase 1 ' I. Evaluation of EPA Review Draft (l) This preliminary estimate is based on the following assumptionss . $150/hour = $l,200/day/person standard consultant fee average of 60 hours/person . 10 members in BCC 150 x 60 x 10 secretarial services, 40 hours at $25/hour 15$ administration and overhead fees Total $ 90,000 $ 1,000 $ 91,000 This figure will vary if the average number of hours/person spent on this part of the project differs from 60 and if the number of RCC members d i f - : fers from 10. : ,i (2) Budget for Meeting The preliminary budget for the meeting is based on the following . assumptions s ; . 2-day meeting at Battelle Seattle Conference Center (BSCC) ^ . |r day traveling to and 1 day traveling from Seattle to home (averaged), i.e., 3f days/person attending the meeting . $l,200/person/day standard consultant fee ,; . 10 participants $ 42,000 BSCC's package rate is asfollowss ; $45/person/day for conference room? 10 persons for 2 days = $90/person/day lodging, incl. breakfast} 3 nights for 10 persons - $ 900 '| $ 2,700 ; Travel (incl. roundtrip Bondon-Seattle for one member5^ , 650) $ 20,006 # 65,600 ; ; 15^ administration and overhead fees $ 9840 Total $ 75,440 : This figure will vary with the exact air fares at the time of travel and the number of participants. 50803 7610 -7 - II. Flanning Workshops This preliminary budget estimate is based on the following assumptionss ' . average of 10 hours/person . 10 members in RCC . $150/hour standard consultant fee . 6 hours secretarial time at $25/hour $ 15,000 $ 150 $ 15*150 15% administrative and overhead fees $ 2 ,2?2 Total $ 17,4^2 This figure will vary if the number of persons or the number of hours/persdn! spent on this part of the project differs from the assumptions. ;> III.Forum Discussions Forum discussions are to be held in Fhase 2 or later. Cost estimates for these discussions will, therefore, be submitted at a later time with the' Fhase 2 budget as an Amendment to this budget. IV. Establishing MARC : Reviewing field of candidates, recruiting candidates, establing objectives and procedures, maintaining communications , .: . 80 hoursprofessional time ($150/hr) . 20 hourssecretarial time ($ 25/hr) $ 12,000 i $ 5Q $ 12,500 ; ; 1 5% administrative and overhead fees $ 1*875 Total $ 14,375 ! Grand Total for Fhase 1 $211,88? 50803 7611 -8- Phase 2 BEC proposes to submit to RJR cost estimates for the work to be conducted in Phase 2 in the form of an Amendment to this budget when more reliable cost figures become available. \-\y\l ! ;: i: n/ii/)0 '! : ''i - : lr 1' : : : :]: Dr. Alfred P. Wehner, President ' ;: Biomedical & Environmental Consultsn, Inc. : - ; i: i i; :I ! !V 6 I 50803 7612 -9- 1' S ; i! ! -i :! ''!