Document 1grkryN5rJeqEv6VbVokdJX9q

) Manufacturing Chemists Association Minutes of Meeting ,W. A. K. APR 111974 TECHNICAL TASK GROUP ON VINYL CHLORIDE RESEARCH Sheraton O'Hare Hotel Rosemont, Illinois February 20, 1974 MEMBERS PRESENT; T. R. Torkelson, CHAIRMAN T. R. Aalto Z. G. Bell, Jr. R. S. Brookman E. M. Dixon, M.D. for W. A. Knapp R. J. Dowling for W. D. Harris B. W. Duck M. R. Gasgue, M.D. N. V. Hendricks C. A. Johnson, M.D. Flynt Kennedy H. L. Kusnetz for R. L. Maycock A. B. Lindquist R. W. McBurney, M.D. W. E. Rinehart George Roush, Jr., M.D. vH. L. Schmidt, Jr. W.' Mfr^ Smith R. N. Wheeler, Jr. K. D. Johnson GUESTS PRESENT: L. H. Ballou, M.D. A. W. Barnes Emilio Bartalini, M.D. K. H. C. Bessant R. L. Bourget W. J. Boyne W. C. Cooper, M.D. The Dow Chemical Company Tenneco Chemicals, Inc. PPG Industries, Inc. Firestone Plastics Company Allied Chemical Corporation UNIROYAL Chemical Division/ UNIROYAL, Inc. The British Petroleum Company Limited, England 01in Corporation Exxon Corporation The Goodyear Tire & Rubber Company Continental Oil Company Shell Oil Company Stauffer Chemical Company Diamond Shamrock Corporation Ethyl Corporation Monsanto Company Borden Chemical/Division of Borden, Inc. Air Products & Chemicals, Inc. Union Carbide Corporation MCA Staff Firestone Plastics Company ICI, Ltd., Plastics Division, England MONTEDISON, Italy BP Chemicals Int., Ltd., England Monsanto Company Borden Chemical/Division of Borden, Inc. Tabershaw-Cooper Associates, Inc. ASI 00009917 Minutes of Tec^_cal Task Group on Vinyl Chloride Research Meeting February 20, 1974 Page Two GUESTS (cont) C. U. Dernehl, M.D. D. P. Duffield, M.D. B. W. Eley J. D. Forbes, M.D. W. R. Gaffey J. W. Goode D. E. Gordon, D.V.M. R. B. Howard E. Q. Hull, M.D. M. L. Keplinger C. H. Kim J. R. Livingston, Jr. W. F. Madden Richard Maier Cesare Maltoni, M.D. X. S. Pasternak Oddi Pietro D. P. Reid, M.D. D. E. Rhoads Ken Schadeberg I. R. Tabershaw, M.D. C. H. Whetstone, M.D. B. M. G. Zwicker Union Carbide Corporation ICI, Mond Division. England Monsanto Company UNIROYAL, Inc. Tabershaw-Cooper Associates, Inc. Industrial BIO-TEST Laboratories, Inc. Industrial BIO-TEST Laboratories, Inc. Shell Chemical Company Union Carbide Corporation Industrial BIO-TEST Laboratories, Inc. UNIROYAL Chemical Division/ UNIROYAL, Inc. Exxon Chemical Company ICI, Plastics Division, England Stauffer Chemical Company Institute of Oncology of Bologna, Italy Esso Chemical Canada Montecatini Edison. Italy London School of Hygiene and Tropical Medicine. England Tenneco Chemicals, Inc. Industrial BIO-TEST Laboratories, Inc. Tabershaw-Cooper Associates, Inc. Continental Oil Company B. F. Goodrich Chemical Company, A Division of The B. F. Goodrich Company 1. Minutes of the Meeting of January 25, 1974 The subject minutes were approved as distributed. 2. Industrial BIO-TEST Oral Progress Report As copies of the detailed quarterly progress report had been earl:er distributed to members of the Technical Task Group on Vinyl iloride Research, the oral presentation was primarily a summary report, augmented by slides illustrating the physical ASI 00009918 Minutes of Technical Task Group on Vinyl Chloride Research Meeting February 20, 1974 Page Three facilities set up for this project. The tabular data presented by Mr. Schadeberg on his slides is reproduced in Appendix A to these minutes. It was suggested that, in future progress reports, the summary tables, as exemplified by this appendix, be furnished in the copies provided for general distribution to the group, and that the detailed data be filed with MCA for the record, but not included in the general reports. Mr. Schadeberg agreed to follow this format in the future. The mortality revealed in Table I was discussed at some length. Members were somewhat relieved to note the improving picture, particularly with respect to losses from hamster cannabilism. It was agreed not to try to replace any animals lost to date, on the grounds that the stresses introduced by such disturbances to established orders of social dominance in the populations in any given cage would tend to perpetuate the earlier situation. The reduced weight gain of the TE-IV Group rats (those with bedding and food in the cages during exposures) was noted, but the significance of this observation, if any, could not be determined. This group will be observed carefully for evidence of systemic toxicity. 3. Report of European Research Dr. Maltoni repeated his presentation of the results of the European research programs, and the description of on going experiments, that he had earlier presented to the OSHA hearing on February 15 in Washington. An updated version of his report, with the inclusion of the tabular data that appeared on his slides, will, upon receipt, be distributed as a separate mailing. The only experiment that is now essentially complete is the initial series of exposures of Sprague-Dawley rats to levels of 10,000 ppm VCM down to 50 ppm. With the exception of the highest exposure group for which early mortality limited the incidence of such cancers, the rats showed a dose-related incidence of angiosarcomas of the liver, as shown in the fol lowing table: ASI 00009919 Minutes of Technical Task Group on Vinyl Choride Research Meeting February 20, 1974 Page Four Exposure levels3 (p.p.m.) Rats with liver angio- sarcomas Number of rats exposed 10,000 6,000 2,500 500 250 50 6 11 9 7 2 0 69 72 74 67 67 64 a Atmospheric exposure of Sprague-Dawley rats to vinyl chloride, four hours daily, five days a week, for 12 months. Note: No liver angiosarcomas were observed in controls or rats exposed similarly to 2500 p.p.m. vinyl acetate. 4. Support of Dow Proposals The TTGVCR voted to request their managements to provide $80,000 for the support of the Dow research as described in their proposal distributed to the group in the MCA mailing of January 29, 1974. 5. Support for Other Research The TTGVCR endorsed the position of the Research Coor dinators with respect to current support of research in the areas of mutagenicity, three-generation feeding studies, and 90-day feeding studies, recommending that these be deferred for the present. 6. Revision of SD-56 - Vinyl Chloride This matter will be attended to after completion of the sub-task groups of their tasks of the development of work practices standards, medical surveillance, and industrial hygiene monitoring and analysis. ' 7. Progress Report from Tabershaw-Cooper Association on the Epidemiology Study The staff of TCA distributed copies of an updated progress report (copy attached to these minutes as Appendix B). They pointed out that, in its present format and state, their tabulation merely reflects a distribution of death and is not ASI 00009920 Minutes of Technical Task Group on Vinyl Chloride Research Meeting February 20, 1974 Page Five ) intended to indicate the existence or non-existence of any specific risk or excess mortality in any category. 8. Tabershaw-Cooper Associates Proposals for Expanded Epidemiological Research Dr. Tabershaw summarized his pending proposals for new studies involving (1) intensifying their efforts to trace missing cases, (2) clinical study of suspect deaths in the mortality study, and (3) undertaking a prospective epidemiology study among high-risk segments of the worker population. He indicated that he would soon be submitting formal proposals for these projects. (Prior to the publication of the present minutes, these proposals were received and distributed to the Technical Task Group by MCA under date of March 12, 1974.) 9. Establishment of a Vinyl Chloride Pathology Register The full task group endorsed the recommendations of the Research Coordinators that the University of Michigan be requested to reactivate and expand their acro-osteolysis registry program to include all categories of occupational illnesses specifically related to vinyl chloride exposure. They requested that MCA pursue this matter with the University, and if necessary, to seek other agencies willing to perform such a service. 10. Report of the Working Group on Analysis and Monitoring The report of the group, in the absence of its chairman, was read, and is attached to these minutes as Appendix C. The tenor or the resulting discussion was that member companies should submit their candidate analytical and monitoring methods for consideration by the working group as soon as possible. The latter should attempt to draft its recommendations in format that provided the maximum flexibility of implementation, as long as the methods employed met appropriate standards of sensitivity, selectivity, and precision. 11. Report of the Working Group on Medical Surveillance The recommendations of this group have been incorporated in the work practices draft submitted by that group (see the following item in these minutes). It was pointed out that the recommended surveillance is required to document the effectiveness ASX 00009921 Minutes of Teci. -ical Task Group on Vinyl Chloride Research Meeting February 20, 1974 Page Six of the environmental controls programs. It was the opinion of the working group that liver function tests are of borderline significance and value as a predictor of the development of angiosarcomata. 12. Report of the Work Practices Working Group The interim draft of their report was presented, with requests for suggestions as to its improvement. It was recom mended that this draft (distributed to the Task Group on March 11, 1974), after review and discussion and possible revision, be presented informally to NIOSH as the personal recommendations of members of the working group now on the NIOSH consultants panel. 13. Future Meeting Schedule In view of the uncertainties surrounding the timing of future federal agency activities relating to the vinyl chloride problem, the Task Group left the time of the next meeting subject to the call of the chairman. Respectfully submitted. Secretary Technical Task Group on Vinyl Chloride Research KJD:mb Minutes Subject to Approval April 8, 1974 Distribution: - Technical Task Group on Vinyl Chloride Research - Attendees - Dr. Tiziano Garlanda 00009922 AS I 9nd*uUial B I O - T E S T Ja&tvuU&ueA, 9nc. I Appendix A TABLE I TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, and Golden Hamsters Summary of Mortality Data Month No. Total Number of Mortalities at End of Month ALBINO RATS Control T-I T-II T-III MF MF MF MF T-IV MF 1 00 00 00 00 0 2 00 20 10 00 0 3 01 20 10 14 0 4 02 41 30 14 0 5 23 51 61 34 0 Month No. 1 2 3 4 5 Control MF 00 00 20 51 82 ALBINO MICE T-I T -II MF MF 00 03 64 19 5 26 6 00 00 30 41 42 T -in MF 00 00 10 47 87 Month No. 1 2 3 4 5 Control MF 54 8 11 8 13 9 15 9 18 GOLDEN HAMSTERS T-I T -II MF MF 44 10 12 12 14 16 16 16 16 75 9 16 12 18 15 19 16 20 T--III MF 25 1C 11 14 13 15 13 15 15 ft ASI 00009923 TABLE II TEST MATERIAL: Vinyl Chloride {Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, Golden Hamsters Summary of Mean Body Weight Values - Rats Group and Test Level Control TE-I 50 ppm TE-II 200 ppm TE-III 2500 ppm TE-IV 2500 ppm Sex 0 M 205 F 160 M 209 F 168 M 201 F 171 M 200 F 165 F 181 Me an Body Weights at Week Indicated (grams) 1 2 348 258 294 335 363 456 188 214 223 235 275 246 286 331 346 448 184 207 223 232 274 261 301 335 360 457 200 208 228 242 289 245 302 326 351 453 185 216 228 240 287 209 223 236 251 282 12 498 299 491 297 490 302 499 303 288 Total Weight Gain (grams / animal) 293 139 282 . 129 289 131 299 * 138 107 TABLE III TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, Golden Hamsters Group and Test Level Control TE-I 50 ppm TE-II 200 ppm TE-III 2500 ppm Sex M F M F M F M F 0 35 29 33 30 36 28 36 28 Summary of Mean Body Weight Values - Mice Mean Body Weights at Week Indicated (grams) 1 2 3 4 8 36 37 39 40 41 29 29 30 32 33 12 43 35 34 35 37 39 39 29 31 31 34 34 43 37 37 37 40 40 38 29 29 31 31 34 42 35 35 35 38 38 40 28 27 30 31 34 43 34 Total Weight Gain (grams /animal) 8 6 10 7 6 7 7 6 ASI 00009925 tynduAttoal b I O - r *" 1 Xaluyuil&ueA. U*c. ASI 00009926 TABLE IV TEST MATERIAL: Vinyl Chloride {Ethylene Derived) . Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, Golden Hamsters Summary of Mean Body Weight Values - Hamsters Group and Test Level Control Sex M F 0 73 77 Mean Body Weights at Week Indicated (grams) 12 348 74 86 99 98 no 80 91 102 104 108 12 120 118 Total Weight Gain (grams /animal) 47 41 TE-I 50 ppm M . 71 F 78 72 79 78 85 89 90 101 96 95 102 114 112 43 34 TE-II 200 ppm TE-III 2500 ppm M 63 F 74 M 60 F 69 61 82 75 82 66 83 70 87 83 89 95 94 94 99 86 87 91 95 92 100 99 108 93 106 36 34 33 37 MALE HAMSTER BODY WEIGHT GAINS WEEKS A UC ` TE-I X TE-II 9 TE-III .30 a> co M 60 o o o o 'O vO to CD A UC TE-I y TE-II 0 TE-III WEEKS ) Appendix B VINYL CHLORIDE EPIDEMIOLOGY STUDY PROGRESS REPORT; FEBRUARY 20, 1974 This is a report of a study in progress. Its purpose is to characterize the mortality experience of vinyl chloride workers up to the end of 1972. The study began in mid 1973 and consequently no attempt was made to obtain mortality data for 1973. The study population consists of individuals who worked for at least one year in a job involving exposure to vinyl chloride before December 31, 1972, and wa$ obtained in the following way. He were supplied by the Manufacturing Chemists Association with the names of 43 North American plants involved in the manufacture of vinyl chloride or polyvinyl chloride. Four of these, which had begun operation after 1968, were ruled out of the study because of the brevity and recency of the exposures. Of the remaining 39, data reduction has been completed for 26, and data are in hand and being coded for six more. Of the remaining plants, four cure now forwarding data to complete the required records on their workers. Study of one has been deferred because it stopped producing vinyl chloride 7 years ago, two others remain to be visited. Data are also in hand, but not yet processed, for a group of European plants. In every plant. Information on eligible workers as defined above was obtained for as far back as each plant's personnel records extended. Those who were not still employed, and who were not known from plant recordes to be either alive or dead, were traced by mail ASI 00009929 or by a retail credit check to determine their vital status as of the end of 1972. The following tables, with the exception of the mortality data, deal with the 26 plants for which coding and key punching are complete. Table 1 shows the follow-up status of the study population of 4415 workers, 89 percent of whom have been traced. The 507 unknowns are still under active follow-up. In any study in wHich follow-up is incomplete, it is important to examine the differences between those who have been found and those who have not. Tables 2 and 3 show the lengths of employment in exposed jobs by date of birth for the two groups. The median birth date is 1934 for those on whom follow-up is complete, and 1933 for those not yet found. The median duration of exposure is 69 months in the first group and 45 months in the second. Similarly, Tables 4 and 5 show length of employment in exposed jobs versus the year in which exposure began for the found and notfound groups. The median date on which exposure began was 1963 for the first group and 1960 for the second. In summary, those not yet found have about the same birth dates as those found, but have a much shorter exposure which began at an earlier age. One interesting fact revealed by Table 2 is that there were 259 workers in the study with 20 years or more exposure and 658 with 15 years or more. These provide an excellent data base for prospective study. -2- ASI 00009930 Table `6 shows a distribution by selected causes for 131 deaths for whom death certificates were obtained. Certificates were included in this table even if the plants from which they came had not yet been processed. For comparison, the corresponding distribution of all U.S. male deaths in 1967 is shown. Because the age distribution of the study population is not the same as that of all U.S. males, and because the number at risk in the study population is not considered, this table is only descriptive. The main point of the table is to show that for rare conditions such as cancers of specific sites, the number of cases appearing in the study is too small to enable definite conclusions to be drawn, in order to investigate such rare conditions, the deaths must be studied in more detail than is possible from information contained in the death certificate itself. When the remainder of the study plants have been processed, an estimated 150 - 200 more deaths will be found, since some of the oldest plants are in the group still being processed. At that time, calculations of the risk of death by broad cause groups will be made. in summary, this study of the mortality of workers occupationally exposed to vinyl chloride is still incomplete. Of the 5000 to 5500 workers ultimately to be included, 4415 have so far been identified. So far the vital status of only 89% of these has been determined. Reports are still coining in on some of the oldest plants, so that the 128 deaths so far known will probably rise to 300 or more as data accumulate. ASI 00009931 -3- Because rare tumors of the kind suspected in recent weeks as being associated with VCM are not clearly identifiable in mortality statistics, a routine study of mortality ratios would not be expected to reveal them unless the incidence was quite high. For this reason this type of mortality study.must be supplemented by case analyses. It should also be emphasized that the collection of identifying information on a population known to have been exposed for periods I* exceeding 10, !15 and 20 years provides a data base that will facilitate ! prospective studies. I i -4- ASI 00009932 Vinyl Chloride Epidemiology Study Table 1 Study Population by Follow-up Status Total 4415 Alive Dead Unknown 3780 128 507 Percent Follow-up - 89 February 15, 1974 ASI 00009933 Vinyl Chloride Epidemiology SCudy Table 2 Distribution by Birth Date and Years of Exposure, for Members of Study Population for Whom Follow-up Is Complete* Birth Date Total 1890-99 1900-09 1910-19 1920-29 1930-39 1940-49 1950+ Unknown Total 3877 10 90 434 910 1103 1261 68 1 1-45 1774 5 21 103 236 458 883 68 Years of Exposure 5-410 10-415 15-420 1052 393 399 221 18 19 17 80 65 95 215 135 185 366 164 101 370 8 1 20+ 259 15 91 139 14 Duration of exposure unknown for 31 workers. February 15, 1974 ASI 00009934 Vinyl Chloride Epidemiology Study Table 3 Distribution by Birth Date and Tears of Exposure, for Members of Study Population Not Yet Pound* Birth Date Total Total 497 1890-99 1900-09 1910-19 1920-29 1930-39 1940-49 1950+ 1 22 60 126 143 142 3 l-<5 366 1 15 34 91 92 130 3 Years of Exposure 5-<10 10-<15 15-<20 73 36 14 22 12 7 4 13 10 10 34 17 12 20+ 8 3 3 2 Duration of exposure unknown for 10 workers. February 15, 1974 4S x 09935 Vinyl Chi ride Epidemiology Study Table 4 Distribution by Year Exposure Began and Number of Years of Exposure, for Members of Study Population on Whom Follow-up Is Complete* Year Exposure Began Total 1940-49 1950-59 1960-69 1970-71 Total 3877 290 1020 2126 441 l-<5 1774 49 163 1121 441 Years of Exposure 5-<10 io-as !5-<20 1052 393 399 34 26 43 131 249 356 887 118 20-*- 259 138 121 *Duratlon of exposure unknown for 31 workers. February 15, 1974 ASI 00009936 I Vinyl Chloride Epidemiology Study Table 5 Distribution by Year Exposure Began and Number of Years of Exposure, for Members of Study population Not Yet Found* Year Exposure Began Total 1940-49 1950-59 1960-69 1970-71 Total 497 73 172 239 13 l-<5 366 50 101 202 13 Years of Exposure 5-<10 10-C15 15-<20 73 36 14 86 30 26 14 35 2 20+- 8 7 1 *Duration of exposure unknown for 10 workers. February 15, 1974 ASI 00009937 1 Table 6 Percentage Distribution by Selected Causes for 131 Deaths in Vinyl Oilorlde Workers, and Percentage Distribution for the Sane Causes in U.S. Males, 1967 Cause of Death S. Males 1967 All Causes 100.ox Malignant neoplasns (140*205) Buccal cavity and pharynx (140-148) Digestive organs and peritoneum (150-159) Liver (156) Respiratory system (160-164) Urinary organs (180,181) Brain (193) Leukemia and aleukemia (204) Lymphosarcoma and other neoplasms of lymphatic and hematopoietic tissues (200-203, 205) Major cardiovascular-renal diseases (330-334, 400-468, 592-594) Vascular lesions affecting CHS (330-334) Arteriosclerotic heart disease (420) Hypertensive disease (440-447) Cirrhosis of liver Motor vehicle accidents (E810-E835) Other accidents (E800-E802, E840-E962) Suicide (E963, E970-E979) Other 16.2 0.5 4.9 0.2 4.6 0.9 0.4 0.8 0.9 53.0 8.9 33.0 2.6 1.7 3.6 3.8 1.5 20.2 Vinyl Chlorldi Workers 100.01(131) 19.8 (26) 2.3 (3) 3.1 (A) 0.8 (D 6.9 (9) 0.8 (1) 2.3 (3) 0.8 (1) 1.5 (2) 47.3 (62) 3.8 (5) 35.9 (47) 1.5 (2) 1.5 (2) 6.9 (9) 6.9 (9) 3.8 (5) 13.7 (18) I ASI 00009938 Appendix C Subcommittee on Analytical and Monitoring Methods Task Group on Vinyl Chlorid Manufacturing Chemists Association Volunteered at meeting of January 25, 197U B. Barnes, ICI Z. G. Bell, PPG R. Henderson, Olin H. R. Hoyle, Dow (volunteered by T. R. Torkelson) F. Kennedy, Continental Oil Subsequent to the meeting, T. Aalto, Tenneco, has -volunteered to serve on the subcommittee. B. Barnes, Z. G. Bell, R. Henderson and F. Kennedy met on January 25, 197b. At that meeting and in subsequent conversations it was agreed that the role of the subcommittee should be to: I. Review literature on methods of analysis for VCM. U. Solicit information from contributors to the M.C.A. vinyl chloride projects on their experience with various procedures for sampling work environments and analyzing the sanplas. III. Evaluate procedures for sampling and analyses. IV. Recommend procedures for sampling and aialyses. It was agreed that there are analytical methods of sufficient sensitivity to detect VCM in air in the concentration range of one to 50 parts per million using reasonable air samples. Flame ionization, infrared, and pyrolysis followed by measurement of conductivity of water in which chloride is trapped are detection methods that can be used. Members of the M.C.A. vinyl chloride project will be requested to submit to Dr. Henderson information on procedures for monitoring and analysis for VCM. The members of the subcommittee will meet after information is received from member companies and circulated for evaluation. Richard Henderson Chairman, Subcommittee on Analysis and Monitoring ASI OOOO9939