Document KJRNqkrE6zGRYn9q8XQYxyrEo

- - 1 v , , c,a- :*:;i:crs social frrCEiVED Record of Meetinc DEC 2 8 1379 VINYL CHLORIDE RESEARCH COORDINATORS R. L. G.bsan, W D. Noverr.be r 2S, 157 9 VIA Offices, Room 407 Washington, D. C. MEMBERS PRESENT R. T. Torkelson, Chairman T. J. Ber.ya z. G. Bell, Jr. W. D. Harris M. N. Johnson V. L. Kirkland W. M. Smith R. N . Wheeler J . T. Seawel1 PP.T' C T NT BY INVITATION j . St afford w. Ad ass -H* U T> Duffield f i. L 3 wrence Dow Chemical Company Ethyl Corporation PPG Industries, Inc. Uniroyal, Inc. The BFGoodrich Company Shell Chemical Company A.ir Products & Chemicals, Union Carbide Corporation Inc CMA Staff Imperical Chemical Limited (ICI) ICI ICI The Society of the Industry Industrie a Plastics 1.0 2.0 Approval of Record of Last Meeting The record of the September 20, 1979 meeting was approved as recorded. Recommendation on pi si r lout icr. of Records of Meeting of the Research Coordinators The Research Coordinators recommended that their records of meetings be sent to the "original" thirty sponsors of biological research programs and to the sponsors of the or:c::v. epidemiological study. CUSAROSS 01061 3.o ay e Geveloped for Handling the Settlement Proposed ne ".erc-rai Counsel :or Industrial 310-TEST Labcra- Tne ser.tlen.ent to be proposed by I3T Counsel within the next severs] weeks is to be sent first to the Vinyl Chloride Audit Task Group (VC/ATG). After taking the action required, the VC ATG will send their recommendations to the Research Coordinators. The Research Coordinators will then, in turn, prepare recommendations to be submitted to the Panel. 4.0 Eoidemiolociical Studv of Workers ___ ___________ I_________I ... . |.|W -- ----------------------------- ____________________________ , -- Chloride Dust Exposed to ___ -- Polvvinvl -* Drs. John Stafford and William Adams of ICI, England present ed a thorough-going review of the study sponsored by ICI and conducted by the Institute of Occupational Medicine (IOM) in Edinburgh. This prestigous research organization made it crystal clear to ICI in the very beginning that, although it was sponsoring the study, ICI would have no voice in the conduct of the study at any point. IOM also made it clear that the study would be conducted primarily for the benefit of the industrial worker. As far as can be ascertained there are no other studies of "nuisance dusts" with which this study can be compared. This presents somewhat of a problem. Eight hundred and eighteen men selected from the present and past work force of a plant manufacturing polyvinyl chloride (PVC) were studied to determine whether PVC dust caused any measurable effects on the lungs of workers exposed to it. Respiratory symptoms such as cough or breathlessness and the results of breathing tests and appearances of the chest x-rays were compared with estimates of the amount of fine PVC dust to which each man had been exposed during his employment at the plant. When studying the effects of PVC dust, allowance was made for the known effects of aging, smoking, and physical on the lungs. It was found that men who smoked cigarettes and who had ala; been exposed to higher amount of PVC dust reported sligh* shortness of breath on exertion more often than smokers w.v had been exposed to lower amounts of dust. This symptom was associated more strongly with aging than smoking as such. The dust effect was not seen amoung non-smokers and ex-sr a- Exposure to PVC dust was not associated with chronic cougn < : sputum production (chronic bronchitis), acute chest illnesses, acute bronchitis, pneumonia, plurisy, or asthma. CUSAROSS OlObl There was a relationship between exposure tc PYC cast ana zhe complaint of breathlessness when hurrying on level -'.round or walking up a slight hill, but this rel aticr.shio was found only in cigarette smokers and not in ncr.-cr-ex smokers. 4.1 Chest___Radiographs au The chest radiographs were read independently by re cognized experts using the ILO U/C International Classification of Radiographs of Pneumoconiosis (Inter national Labor Office, 1972). The medically qualified readers were chosen to represent a range of inter tations of the presence of small radiographic opa and on the basis of systematic inter-reader differences recorded in previous work. None of the radiographic experts were employed by IOM. One of the three experts detected small, round opacities more commonly in the radiographs of men with higher exposure to PVC dust than in those with lower or no ex posure. The other two readers did not detect an effect of PVC dust although they observed small, round opaciti*--in a few cases. The opacities seen by these readers wv. not more common in those with higher exposures tc dust than in those with lower or no exposure. Prevalence c: small, round opacities was not related to the presence c: chronic cough or sputum, or histories of chest illness. The IOM report concludes with the opinion that the effort of PVC dust inhalation on lung function is cf the same order of magnitude as that of cigarettes and approxi mately one-seventh that of aging. They also conclude that 'while these results are not unduly alarming, they do indicate that further measures to reduce individual i dust exposure would be prudent. 4.2 Recommendations of the Research Coordinators 4.2.1 The Research Coordinators recommended that Id send a copy of the 10M report to NIOSH. This recommendation was contingent on subsequent advice given to the ICI representatives by their legal counsel in Wilmington. 4.2.2 The Chairman of the Research Coordinators, dm I R. Torkelson appointed Mr. R. N. Wheeler to pre pare a summary statement containing salient findings presented in the IOM report. Or cm; ing his statement, Mr. Wheeler is tc fcrwar:. : to S?I and to the Project Administrater. 1; ' receiving it, the Project Administrate:: is : CUSAROSS 01063 it immediately to CMA's General Counsel who, m turn, is to collaborate with SPI's Counsel, Mr. Joseph Hadley, on the preparation of the final statement. After joint agreement of SPI and CMA counsels, the document will be sent to the Research Coordinators to secure their approval of technical content. After the Research Coordinators have approved the document in final form, it will be dis tributed to all Panel members 5.0 Extension of Basic Epidemiological Study, Five-Year Upuate Dr. Torkleson presented a status report on preparatory work in progress. His review included the document recently pre pared by the Project Administrator entitled "Specifications on which Proposals and/or Bids are to be Based for a FiveYear Epidemi logical Update on Vinyl Chloride ana Critique or. Factors Relevant to the Study". These bid/proposal specifi cations emphasize that an evaluation of data currently being archived by Equitable Environmental Health, Inc. (EEH) is a necessary prerequisite to both the "brain study", should it be conducted as a separate entity, and to the larger investi gation, the five-year epidemiological update. The cohort data used in the basic epidemiological investiga tion of VC workers is stored at the Rockville, Maryland offices of EEH. These consist of unit files and computer cards for each cohort member, a series of computer print-cuts on study analyses, and pertinent correspondence with partici pating plants. The unit files contain the raw data collected from plant records with the data reduced to the study format. The computer cards are punched with the data so reduced. The computer print-outs contain the data from which the compara tive tables were prepared for the reports. Review of these data in detail is necessary to the development of a defini tive study protocol, a responsably valid cost, and a performance time estimate. The epidemiological update is to extend from December 31, 1S72 tc December 31, 1977. 1) An effort will be made to determine the vital status as of December 31, 1977 of the eight thousand nine hundred and seventy cohort members who were determined to be alive on December 31, 1972. 2) An attempt w'ill be made to determine the vital status of the four hundred and ninety-six cohort members who were lost to follow-up during the previous study. CUSAROSS 01064 6.0 7.0 3) Efforts will be r.ade to retrieve death certificates for cohort ne"iers identified as deceased based cr, the follow-up effort. 4) The complete study population will be analyzed using the expanded life table program, for example, Monsons's program (Harvard) or Enterline's Program (University of Pittsburgh). After deliberating on factors relevant to the brain study and to the overall epidemiological update it was VOTED: To request commitment of $30,000 to cover: 1) A study or asse ssment of the data currently in storage at EEH, 2) A case control study of brain tumors, and 3) The preparation of a protocol for the five-year epidemiological update. The Vinotex Study Dr. William Adams reported very briefly on a study conducted within the Vinotex Group in England. This research is an attempt to corrolate dose-related VC exposure and coronary disease. Amoung other phases, are subsidiary investigations on triglycerides. Following Dr. Adams' review. Dr. M.N. Johnson will follow-up with Dr. Tamburro (Director of Researc at the University of Louisville) on observations made by Dr. Tamburro and his associates on triglycerides and thei possible relationship with VC exposures and coronary inci Evaluation by Dr. J. M. Norris of the Edgewood Arsenal Study on Vinyl Chloride .Monomer At the request of the Panel Chairman, Dr. T. R* Torkelson, Dr. J. M. Norris evaluated the final report issued on the sccalled Edgewood Arsenal "Single-Hit Study" sponsored by the Consumer Product Safety Commission (CPSC) under an inter agency agreement with the Chemical Systems Laboratory (formerly Edgewood Arsenal). Dr. Norris reported that the final Edgewood report contains the same deficiencies as did the draft report. Specifica11y, the report contains discrepancies both in the reporting cr the number of animals per test group, that were placed or. tn_ various studies, relative to the numbers that were evaluate . Further discrepancies were found in the numbers of animate observed with tumors as reported in various tables. Rur--.-^roe months in which the studies were terminated were in correctly reported. CUSAROSS 01065 U TJ 6 Data in the report indicate that bo h y> the ICR and A/J .Cc had relatively high background inci dences of pulmonary adenomas. The ICE ".ice also had ei tier a chronic pneumonic condition or developed pneumonitis during the study. The marked body vieyht loss in the mice both the vinyl chloric; exposed and control animals, during the twenty-eighth and fc forty-second weeks of the studies s uggest that external factors may have contributed to the pneumonic conditions, Except for the male ICR mice in the group exposed to 50,000 ppm vinyl chloride, the incidence o f pneumonitis is roughly proportional to the incidence of pu Imonary adenomas. However, since the handling/housing of the control mice relati' to the exposed mice is not reported and since no statement : made as to whether medications were administered, the signi: canoe of the apparent association c n n n n + K <=> rnnrl iipph . 8.0 Proposed Action Pertinent to the Eduewood/CPSC "Sinale-Hit S t udv Appropriate follow-up action will be taken to that outlined under Section 14.0 in the Record of Meeting, September 20, 1979 . Dr. Torkelson, Dr. Hatfield, and Mr. Wheeler will pursue additional data on the respective study categories listed under section 14.0. CMA's action will be contingent on the results of the efforts of these gentlemen. 9. o An Update on Dr. John Stafford's Worldwide Registry of Angiosarcoma of rhe Liver Vinyl Chloride Polymerization Workers Dr. Stafford presented the most recent data on his widely re spected registry of angiosarcoma cases. These data are as follows: Cou-n_t_ry Canada France Germany Sweden Uni red Kingdom United States _________YEARS______________________ 1977 1978 1979 10 22 3 4* 10 00 12 0 2 0 0 2 0 *Plus two unconfirmed 10.0 VCM/PVC Symposium A symposium on Vinyl Chloride monomer and polyvinyl chi or. is to be held in Washington, D.C. "sometime curing toe 1 - cars of February". It is currently anticipated [by regie t a rives of Ur. Enfanti's office) chat if will be a owe - CUSAROSS 01066 s"_: raving as its theme "Reevaluation of the Toxicity : r.'an 1 c i he ant P ~ 1 w i r.v 1 ch lo r ice and Structural Analc- ce said rurrner mat it is m m ___ <J- . . that our (CMA and the Panel's) ruticn will be v c. em.ed. No information other than ve is available a this time. sarcoma Over-Diagnosed in England Dr. Dai-id Duffiela reported that a Panel of pathologists in Er.d and have "thrown out" (invalidated) the readings on about one naif of the slides on which angiosarcoma diagnoses were based. Action of these expert pathologists results in the number of angiosarcoma cases in England during a five year oeriod being reduced by approximately one half. J.T. Seawell Project Admini Vinyl Chloride Eject to Approval U'' f/) CUSARONN ()h)b7