Document 5gk52G7VvqQ4kroaJMg19vGN

' i\c t CORPORATION\ 'OOOMVKWDflr.f rRUWOAL CONNECTICUT06*11 (203} 3T1 C'OJ July 5, 1983 .tCEIVEO JUL 13 1983 - o. IHilNSOHN, M.0 Or. Hilton C. Lewinsohn Union Carbide Corporation Old Ridgebury Road Danbury, CT 06817 Dear Hilton: Enclosed are copies of Task Order No. 3 and Task Order No. 7 issued by OSHA In connection with the proposed revision of the Asbestos Standard and a copy of a petition from the IAM requesting an ETS of 0.1 for asbestos. Attached to the 1AM petition is a report by Or. Mancuso. Note the misleading reference to the Manhein plant on page 509. Sincerely, Enclosures eg UCC 015233 TASK ORDER M3.3 HEALTH EFFECTS RISK ASSESSMENT TOR EXPOSURE TO ASBESTOS Contract W-9-F-2-0074 Energy Resources Co. Inc. One Alewife Place Cambridge, MA 02140 UCC 015234 HEALTH EFFECTS RISK ASSESSMENT EOS EXPOSURE TO ASBESTOS I. INTRODUCTION OSHA is required ty law to estimate the extent of expected benefits that an OSHA standard will produce. The Agency must determine that a significant risk exists and that a standard is reasonably necessary or appropriate to provide safe and healthful enployment. Risks associated with exposure to carcinogens are expressed in terms of years of foregone life expectancy or of material impairment. TO produce these estimates, OSHA requires data and assumptions about probable dose/response, latency after initial exposure, adverse affects of cumulative exposure, effects of high exposure levels of brief duration, and a number of other factors which may significantly influence health outcomes. Although it is obvious that precise scientific knowledge about the effects of marry of these factors is rot currently available, the Agency has a burden of proof to demonstrate that further regulation is reason ably necessary and appropriate. Accordingly, it is requested that data, reasonable assurrptions and expert opinion be used to complete the follow ing tasks. UCC 015235 IX. PERTOSMANCE MEASUREMENT CRITERIA The contractor will provide professional services and technical assistance in developing and completing this study. Contract performance will be measured against the requirements in this statement of work and in detailed work plan to be submitted by the contractor. Due to the nature of work inherent in this type of study, OSHA will not provide exact instructions concerning how the contractor will accenplish the task. The contractor's response will be' critical in satisfactory performance of the task. In addition, the quality of work will be judged upon the cotpleteness of the collected data, the validity of the data sources used, the assumptions and model used, and the general management of resources within established time and budget constraints. III. SCOPE OF WORK Environmental Sciences Laboratory of Mount Sinai School of Medicine shall provide general assistance to OSHA regarding analysis of health data pertaining to asbestos. These efforts are for the purpose of helping OSHA to develop a revised regulation for asbestiform fibers. Tasks 1, 2, 3a, 3b, and 6 necessitate preparation of brief reports. Task 3c necessitates pre paration of an outline for a scientific paper, and Task 4 and 5 necessitate provision of written comments. The expiration date for this particular contract shall be May 25, 1983. The due dates for tasks as listed below, are May 9, 20, and 25, except for the requirement that Task 5 be completed within 5 days of receipt of materials frcnt OSHA. Specific tasks include, but jure not limited to, the following: UCC 015236 <_ f v 1. (a) Critical analysis and discussion of current dose-extrapolation irodels for prediction of excess mortality from pleural and peritoneal mesothelioma; selection of most reasonable model(s) for prediction of mesothelioma risk, with acacnpanying discussion of basis for selection; generation of estimates of excess mortality from mesothelioma frcm exposures of: 0.1 f/ml - years 0.2 f/ml - years 0.5 f/ral - years 2.0 f/ml - years 4.5 f/ml - years 9.0 f/ml - years 22.5 f/ml - years 90 f/ml - years , (Note: All estimates shall be accompanied by documentation, including potency coefficients, such that OSHA can reproduce the estimates). Due Date: May 20, 1983 (b) Critical analysis and discussion of current dose-extrapolation models for prediction of excess mortality frcm lung cancer and other asbestos-related malignancies; selection of most reasonable model(s) for prediction of lung cancer risk and risk of other asbestos-related malig nancies, with accompanying discussion of basis for selection: generation of estimates of excess mortality frcm lung cancer and frcm other asbestos- related malignancies frcm exposures of same cumulative exposures as listed above. (Note: All estimates shall be accompanied by documentation, including potency coefficients, sued: that OSHA can reproduce the estimates). Due Date: May 20, 1983 UCC 015237 o> 2. Critical analysis and discussion of current dose-extrapolation models for prediction of excess mortality frcm asbestosis; selection of most reasonable model (s) for prediction of mortality from asbes tosis, with accompanying discussion of basis for selection; generation of estimates of excess mortality frcm asbestosis frcm exposures of: 0.1 f/ral - years 0.2 f/ml - years 0.5 f/ml - years 2.0 f/ml - years 4.5 f/ml - years 9.0 f/ml - years 22.5 f/ml - years 90 f/ml - years < (Note: All estimates shall be accompanied fcy documentation, including potency coefficients, such that OSHA can reproduce the estimates). Due Date: May 20, 19B3 3. Critical analysis and discussion of risk of asbestos-induced diseases frcm short-term and intermittent exposures to asbestos, including the following tasks: (a) Selection of most reasonable dose-extrapolation model(s) for prediction of excess mortality from asbestos-indueed diseases due to short-term and intermittent exposures, with acccnpanying discussion of basis for selection. (Note: OSHA understands that predicting morbidity is considerably more complicated than predicting mortality, such that selection of a model for morbidity and generating estimates for excess morbidity may not be possible by the expiration date of this contract). Due Date: May 25, 1983 UCC 015238 (b) Generation of estimates of excess mortality frcxn asbestos-induced diseases due to short-term and intermittent exposures, such as those experienced in the construction industry and automotive aftermarket. (Note: All estimates shall be accompanied by docimentation, including potency coefficients, such that OSHA can reproduce the estimates.) Due Date: May 25, 1983 (c) Prepare outline for article, suitable for publication in a scientific journal, consisting of a review of the evidence for the pro duction of earlyasbestosis, asbestosis, and cancers by short-term and intermittent exposures to asbestos. This article would also review cases of asbestos diseases induced by short-term and intermittent exposures that are presently in the files of Mt. Sinai, as well as pertinent epideniologic studies contained therein. (Mote: CSHA does not expect this paper to be ccmpleted by the expiration date of this contract). Due Date: May 25, 1983 4. Providing critical contents on the draft preamble section cn health effects prepared ty OSHA for a Notice of Proposed Rulemaking on asbestos; reviewing the preamble for canpleteness and accuracy of the health infor mation and risk analyses. Due Date: Within 5 days of receipt of draft section(s) frcm OSHA. UCC 015239 5. In the evaluation of illnesses that may be averted if an OSHA standard on asbestos which lowere the PEL from 2 f/cc to 0.5 f/cc or 0.1 f/cc (ceiling from 10 f/cc to 5 f/cc) is promulgated, OSHA must determine the appropriate values for several key parameters: * age at first exposure * latency associated with asbestosis, mesothelioma, lung cancers, and other cancers * smoking rates for the affected population. (a) At this time, OSHA expected to set the parameter for the age at first exposure at 25 years. Do you perceive any problems with this assumption given the context in which it will be used? If so, what are those problems and what is the appropriate setting for this parameter? (Please provide documentation for any proposed changes). Due Date: May 9, 1983 (b) The latency periods for the illnesses associated with asbestos exposure must also be determined. At this time, the latency associated with lung cancer ranges from 20-40 years, with a peak at 30-35 years. Do you perceive any prolens with these assumed latencies? If so, what are those problems and what is the appropriate setting for these para meters? (Please provide documentation for any proposed changes). (c) At this time, OSHA intends to assure that the groking rates for the affected population mirror the rates for the general working popula tion. Do you perceive any problems with this assunption given the context in which it will be used? If so, what are those problems and what is the appropriate assunption? (Please provide docunentation for any proposed changes). Due Date: May 9, 1983 UCC 015240 6. Critical analysis and discussion of mineralogy of talc, including talcs which contain asbestos and talcs which don't contain asbestos; discussion of issues and mineralogy/industrial hygiene studies regarding asbestos contained in talc; drawing conclusions on most reasonable position to take on issues of talc mineralogy relating to asbestos regulation. Due Date; May 20, 1983 IV. CDJFIDEOTIALrnf The contractor agrees not to release to the public the draft preposed standard or any analysis conducted or data collected during the performance of the Task Order unless directed to do so by OSHA. It is understood, however, that it will be necessary for the contractor to discuss the contents of the proposed standard in sufficient detail to develop cost estimates. Such discussions will be approved by the COTR prior to any disclosure. All data used in the development of the economic ispact studies will be made available to OSHA on request. Ito premise of confidentiality shall be made by the contractor to its data sources. The sources for all factual information will be referenced in the report. A bibliography will be provided. UCC 015241 r.u 88888 R _ 888888 8 V LABOR & ESTIMATED COST FOR TASKS #1, 2, 3a S, b NAME CATEGORY RATE HOURS Dr. Nicholson Dr. Selitoff Mr. Henneberger Ms. Tarr Project Director Sr. Tech. Specialist Analyst Jr. Analyst Clerical $54.23 48.85 28.36 23.72 21.10 130 60 30 50 120 TOTAL ESTIMATED COST j AMOUNT $ 7,049.00 2,931.00 850.80 1,185.00 2,532.00 $14,549.70 LABOR & ESTIMATED COST FOR TASKS 3c, 4 & 5 NAME CATEGORY RATE HOURS Dr. Selitoff Dr. Nicholson Dr. Lilis Dr. Langer Mr. Henneberger Project Director Sr. Tech Specialist Sr. Tech Specialist Sr. Tech Specialist Analyst Clerical $54.23 48.85 48.85 48.85 28.36 21.10 30 25 20 10 10 60 TOTAL ESTIMATED COST AMOUNT $ 1,626.90 1,221.25 977.00 488.50 233.60 1,266.00 $ 5,863.25 888 8 NAME Dr. Langer Dr. Selltoff IABOR & ESTIMATED COST FOR TASK 6 CATEGORY RATE HOURS Project Director Sr. Tech Specialist Clerical $54.23 48.85 21.10 20 5 20 TOTAL ESTIMATED COST AMOUNT $ 1,034.60 244.25 422.00 $ 1,750.85 , 98888 TOTAL ESTIMATED IABOR & COST SUMMARY RATE HOURS Project Director Sr. Tech Specialist Analyst Jr. Analyst Clerical $54.23 48.85 28.36 23.72 21.10 180 120 40 50 200 f.ST FOR TASKS #1, 2, 3, (a.b. c). 4 5 AMOUNT $ 9,761.40 5,862.00 1,134.40 1,186.00 4,220.00 $22,163.80 UCC 015242