Document Ne9YRx4zJ25oBykE3g7x2peGQ

t ) MANUFACTURING CHEMISTS ASSOCIATION Minutes of Meeting JOINT SESSION of the MANAGEMENT CONTACTS OF COMPANIES SPONSORING THE VINYL CHLORIDE RESEARCH PROGRAM and the TECHNICAL TASK GROUP ON VINYL CHLORIDE RESEARCH MCA Conference Room 9:00 AM Washington, D.C. January 25, 1974 PRESENT: T. R. Aalto A. R. Adams L. H. Ballou, M.D. A. M. Barnes J. T. Barr Z. G. Bell, Jr. W. J. Boyne R. S. Brookman A. S. Cummin C. H. Dernehl, M.D. Ernest Dixon for W. S Ferguson B. W. Duck D. P. Duffield, M.D. H. E. Everson W. D. Harris Richard Henderson for M. R. Gasque, M.D. E. Q. Hull, M.D. W. M. Iliff Tenneco Chemicals Inc. Air Products & Chemicals, Inc. Firestone Plastics Company/Division of the Firestone Tire & Rubber Company Imperial Chemical Industries Limited, Plastics Division Air Products & Chemicals, Inc. PPG Industries, Inc. Borden Chemical/Division of Borden, Inc. Firestone Plastics Company/Division of the Firestone Tire & Rubber Company Borden, Inc. Union Carbide Corporation Allied Chemical Corporation British Petroleum Company, Ltd. Imperial Chemical Industries Limited, Mond Division Diamond Shamrock Corporation UNIROYAL, Inc. Olin Corporation Union Carbide Corporation Uniroyal Chemical Division of UNIROYAL, Inc. ASl 000010389 I C. A. Johnson, M.D. M. N. Johnson, M.D. Flynt Kennedy W. A. Knapp H. L. Kusnetz for R. L. Maycock A. B. Lindquist J. R. Livingston, Jr. R. W. McBurney, M.D. Thomas McDonach Richard Maier D. A. Rausch for.D. C. Nuechterlein R. J. Reynolds D. E. Rhoads W. E. Rinehart George Roush, Jr., M.D. H. L. Schmidt, Jr. L. J. W. M. I. R. T. R. Anton Schuman Smith Tabershaw, Torkelson Vittone M.D. R. N. Wheeler B. M. G. Zwicker B. M. Barackman A. C. Clark K. D. Johnson V. H. Peterson The Goodyear Tire & Rubber Company The B. F. Goodrich Company Continental Oil Company Allied Chemical Corporation Shell Oil Company Stauffer Chemical Company Exxon Chemical Company, U.S.A. Diamond Shamrock Corporation Exxon Chemical Company, U.S.A. Stauffer Chemical Company Dow Chemical, USA Shell Chemical Company Tenneco Chemicals, Inc. Ethyl Corporation Monsanto Company Borden Chemical/Division of Borden, Inc. Continental Oil Company Air Products & Chemicals, Inc. Tabershaw-Cooper Associates, Inc. The Dow Chemical Company B. F. Goodrich Chemical Company/ Division of The B. F. Goodrich Company Union Carbide Corporation B. F. Goodrich Chemical Company/ Division of The B. F. Goodrich Company MCA Staff MCA Staff MCA Staff MCA Staff 1. Reoort from The B. F. Goodrich Company After the meeting was called to order by Mr. Clark, and after those present had introduced themselves to the group, this portion of the morning session was turned over to Mr. Anton Vittone. He first called upon Dr. M. N. Johnson, who summarized the chronology and clinical picture of the three cases of ASI 000010390 angiosarcoma of the liver in Goodrich vinyl chloride workers that were the subject of their press release of January 23. This information had earlier been presented to NIOSH and the Kentucky officials, January 22 and 23, respectively. He also described their program of clinical surveillance, including SMA-12 profiles, on all employees with vinyl chloride exposure. Dr. Zwicker then related the steps Goodrich has taken to minimize exposures, from those involving improved maintenance, housekeeping, and plant ventilation to changes in work practices. He stressed the uncertainties inherent in estimating employee exposures from random grab samples for atmospheric analyses, and described their use of portable indicating instrumentation (a Century Organic Vapor Analyzer) in detailed surveys of the work areas to identify locations for installation of permanent sampling probes for their centralized, automatic monitoring equipment (based on a Bendix 8401 Total Hydrocarbon Analyzer). This instrument, although not specific for vinyl chloride, is reliable, responds rapidly, and has an essentially linear response over three decades^of concentration of vinyl chloride vapors in the air. A"*p5per describing their system, "An Instrumental System for the Monitoring of Vinyl Chloride Monomer in Plant and Laboratory Work Areas," by L. B. Crider, was distributed to those present. Dr. Zwicker also described Goodrich's procedures for informing employees at risk of the nature and status of the problem, and the steps that are being taken by Goodrich for their protection. Employee briefings, in small groups, were conducted by management. At the request of the employee, consultation with medical staff is being provided on an in dividual basis. Dr. Irving R. Tabershaw, consultant to Goodrich and president of Tabershaw-Cooper Associates (the firm conducting the industry-sponsored mortality study of vinyl chloride workers) then was called upon to comment on the significance of the events related by the Goodrich representatives. Although acknowledging that identification of the pathology observed with vinyl chloride exposures was still tentative, he stressed the overwhelming likelihood that the three cases of angiosarcoma of the liver were related to industrial factors, and that at present, vinyl chloride exposures were by far the most significant common factor in their industrial exposure histories. ASI 000010391 Dr. Tabershaw also gave an oral update report on the status of the MCA study. TCA has now identified 122 deaths among the population under study, and expects to find 30 to 40 more by the time the remaining plants have reported and follow-ups have been completed. One hundred two death cer tificates have been secured, with no obvious abnormalities in the pattern of causes of death, nor any case giving rise to immediate suspicion that it might be industrially related. He stressed, however, that age-specific rates had not yet been calculated, and that his comments were based upon a firstimpression response to the data. It was the impression of the Goodrich representatives that NIOSH and OSHA would probably move toward an emergency "work practices standard" for vinyl chloride rather than at tempting to set a numerical TWA or ceiling value standard. 2. MCA Reaction to Problem 2.1 MCA-NIOSH Liaison After discussion of possible steps MCA might take to retain industry initiative, it was moved, seconded and carried that MCA immediately call Dr. Marcus Key, renewing our offer of assistance and support for the studies NIOSH was con sidering undertaking, and confirm this by letter from an MCA officer. Mr. Best, MCA Vice President and Secretary-Treasurer, made such a call the afternoon of January 25, and sent the con firming letter the same day. A copy of his letter to Dr. Key is attached to these minutes as Appendix A. The Research Coordinators were delegated the responsibility for coordinating the technical back-up to the MCA offer of assistance in NIOSH program development and execution. Those areas in which MCA might be most helpful were judged to be diagnostic procedures and medical surveillance, work practices, and industrial hygiene monitoring and analytical procedures. 2.2 MCA Liaison with Industry The group urged MCA to take appropriate steps to see that companies handling vinyl chloride but not members of the group sponsoring the present study programs be made aware ASI 000010392 -5- of the problem. It was the consensus that this could best be done if they were to join the group in the sponsorship of any expanded and accelerated research programs that it might under take. MCA was asked to extend a renewed invitation to VCM and/ or PVC producers who had declined to join the group at the time of its formation. 2.3 MCA Participation in OSBA Hearings In anticipation of public hearings by OSHA on the emergency standards they are expected to propose for vinyl chloride, MCA was asked to prepare testimony for possible presentation at such hearings. The MCA statement would be limited primarily to a narrative history of the activities of the Association and the members of the group of companies supporting the animal exposure and epidemiological studies now underway under MCA's aegis. 3. Formation of Task-Group Units It was moved, seconded and carried that the TTGVCR be instructed to organize three sub-task groups to expedite the development of plans and recommendations in the three areas referred to in item 2.1 above. 3.1 Medical Sub-Task Group Dr. M. N. Johnson was appointed by the Chairman to serve as leader pro-tem of a medical group to develop recom mendations for guidelines for industry practices in the medical surveillance of workers at risk to vinyl chloride occupational exposures. Such guidelines may include, but are not limited to, recommendations as to pre-employment and routine physical ex amination procedures and standards, diagnostic criteria for the recognition of early or incipient injury from vinyl chloride exposures, and the medical management of such injury should it occur. Those initially named to serve on the medical group include L. H. Ballou, M.D. (Firestone), C. H. Dernehl, M.D. (Union Carbide), D. P. Duffield, M.D. (ICI), E. M. Dixon, M.D. (Allied Chemical), R. W. McBurney, M.D. (Diamond Shamrock), and George Roush, Jr., M.D. (Monsanto). ASI 000010393 3.2 Work Practices Sub-Task Group Mr. R. N. Wheeler was appointed leader pro-tern of a group to study, identify problems, and recommend operating procedures and facility design in the manufacture, transport and consumption of vinyl chloride monomer to limit exposures to the lowest levels consistent with safety, and to secure freedom from health hazards. Specific areas of responsibility include, but are not limited to workplace air, engineering guidelines, work and operational practices, protective equipment, industrial hygiene procedures, and process modifications. The following persons were named as members of the group: Mr. A. M. Barnes (ICI), Mr. J. T. Barr (Air Products), Dr. Z. G. Bell, Jr. (PPG), Dr. W. J. Boyne (Borden Chemical), Mr. H. R. Hoyle (Dow), Mr. H. L. Kusnetz (Shell), and Mr. Richard Maier (Stauffer). 3.3 Industrial Hygiene and Monitoring Sub-Group Dr. Richard Henderson was appointed pro-tern leader of a sub-group to develop recommended practices and guidelines for the conduct of industrial hygiene monitoring and sample analysis for the evaluation of steps taken for the reduction of exposures to vinyl chloride, and to detect promptly and with confidence conditions of exposure presenting potential threat to the health and safety of workers. The design and conduct of interlaboratory comparisons of accuracy, precision and specificity of sampling and analytical procedures are to be considered specific tasks of the group. Initial assignments to this group include Mr. A. M. Barnes (ICI), Dr. Z. G. Bell, Jr. (PPG), Mr. H. R. Hoyle (Dow), Mr. Flynt Kennedy (Continental Oil), and Dr. B. M. G. Zwicker (B. F. Goodrich). 4. Publicity on Vinvl Chloride Hazards A number of articles from the European popular and tech nical press, relating to alleged hazards of working with vinyl chloride, were called to the attention of those present. Copies of translations of these articles are attached to, but not incorporated as a portion of, these minutes. The bibliographic references to these articles are tabulated below ASI 000010394 -7- 1. S. Juhe, C. E. Lange, G. Stein, G. Veltman, Deutche Medizinische Wochensckrift, 98. 2034-2037 (1973) 2. Kolner Stadt.-Anzeiger, 14 December 1973 3. Weser Kurier, No. 300, p. 11, 20 December 1973 4. Frankfurter Allgemeine Zeitung, 20 December 1973 5. Der Spiegel, No. 50 (1973) 6. Frankfurter Allgemeine Zeitung, 2 January 1974 5. Future Meeting Schedule The next meeting of the TTGVCR will be held at the Sheraton O'Hare (North), near O'Hare Airport, Chicago, on Wednesday, February 20, 1974. The Sub-group on Work Practices will meet Tuesday AM, at that hotel, in the suite of the TTGVCR officers, and the Research Coordinators will meet there at 2:00 PM the same date. If other sub-groups are to meet in conjunction with this meeting of the TTGVCR, they will be so notified. The TTGVCR meeting agenda will be distributed shortly. Respectfully submitted. Kenneth D. Johnson, Ph.D. Secretary, Technical Task Group on Vinyl Chloride Research KDJrmb Minutes Subject to Approval January 30, 1974 Distribution - Technical Task Group on Vinyl Chloride Research - Vinyl Chloride Research Management Contacts - Attendees of Meeting cc : Mr. D. M. Elliott Dr. Tiziano Garlanda ASI 000010395 GEORGE E. BEST VICE PRESIDENT SECRETARY-TREASURER 1- FORMATION COPY MANUFACTURING CHEMISTS A^^IATMON T825 CONNECTICUT AVENUE, N.W, WASHINGTON, D. C. 20009 (202) 483-6126 January 25, 1974 Marcus M. Kay, M. D. Director National Institute for Occupational Safety and Health Public Health Service Department of Health, Education and Welfare 5600 Fishers Lane Rockville, Maryland 20852 Dear Mark: As you well know from our meeting in July 1973, MCA has a deep interest in research into problems which have arisen concerning vinyl chloride monomer (VCM). We now understand that NIOSH has immediate plans to initiate further action resulting from the voluntary report to you by B. F. Good rich of possible health hazards at its Louisville, Kentucky, facility. We wish to reaffirm our strong desire to work with NIOSH as you see fit and pledge our full cooperation and support. Naturally, we would like to meet with you and participate in any ongoing program at the earliest possible time. We believe the technical expertise within MCA member companies could be particularly helpful in the areas of defining health hazards asso ciated with VCM production, workplace and medical surveillance and work practices necessary to limit exposure. I am writing offering our services because of my former responsi bilities as technical director. These duties now have been assumed by Mr. A. C. Clark. 1 trust I will hear from you soon and that you will then have the opportunity to meet Mr. Clark. Sincerely, ASI 000010396 75-12-27 Deutsche Medizinische Wochenschrift, ^8 (43), p. 2034-2057, 1973 "On the So-called Vinylchloride Disease" By 5 Jtlhe, 6. E. Lange, 6. Stein, and G. Veltman University Skin Clinic of Bonn Director: Prof. Dr. Leinbrock * Since 1958. when the first information on the hazardous health aspects to workers in the vinylchloride manufacturing industries was found, and especially since 1965. when the same effects were found affecting workers in the polyvinylchloride industry (PVC), and through further reports on this subject (3, 4, 7, 8, 12, 28), attention has been drawn to thiE branch of the chemical industry. This deals with a disease similar to a skin and bone affecting scleroderma, but a disease un explainable in etiology and pathogenesis. The main symp toms of this have been the Raynaud syndrome, nodular to large area dense skin alterations and band-like osteolysis in the finger phalanges. We could report our first observations on this.disease / type in Germany in 1972 (15, 16, 17)* As the clinical picture was at first comparable to a specialized form of progressive scleroderma, we submitted all employees to' a painstaking ASX 000010397 2 lnt rnal examination to d termine if visceral participation was also present. Recently, we reported completely 08) on the results found up until the end of 1972. These reveal new aspects to be used in the judgement of this disease and, as we believe, also may give new suggestions in the research. The 13 workers examined in the April-December 1972 time period were 29 to 52 years old (average age: 39 years), and had worked at least two, and at most 18 years (average period: 7 years) in a PVC-manufacturing plant at alternating jobs, although mainly as autoclave TCleanerg* The first disease symptoms appeared one and one-half to three and one-half years after first working there in eleven patients, and in two cases seven and eleven years after first working. Symptoms and Findings i The most frequent initial symptoms of the anamnetical details are increasing sensity to coldness in the hands and feet, a feeling of deafness, and crawling parietosis. In addition, pressure pain in single fingers, a thickening of the end finger joints and weakening of the nails as well as general complaints of excessive tiredness, forgetfulness and slowing down, syncopal dizziness, nauseau during work. Increased perspiration and upper abdominal pain. A major role in the diagnosis of this disease is played by the alteration of the skin: Seven patients proved to have drumstick-like (clubbed) thickened finger end phalanges (club procurements and shortening, watch-glass nails, shortening of ASI 000010398 ) 3 the nail plate). We saw scleroderma-like skin alterations In 8 patients: small knots or more spread out; very coarse and relatively sharply defined, usually covering the surface skin projecting Infiltrate on the outstretched hands, the distal third of the arms under the elbow, and the area of the cheeks. Three patients had no clinical skin alterations. The histology findings of the excision specimens (from the left or right hands) of all patients were relatively uni- form. Besides hyperorthocytosis and epidermidosis, there was an expansion and increase of capillaries in the upper cutis. An increase, widening and homogenation of the collagen bundle and a clear rarefaction and fragmentation of the elastic fibers was evident. The same findings in the epi dermis and the fibers of the upper cutis were proven to exist in the patients without clinical skin alterations. The histology alterations In the epidermis and the collagen 4 connective tissues are similar to the edematosis to.infiltra tive stage of progressive scleroderma. Here, however, a clearly defined border is seen between that of possible but to some extent considerable injury of the elastic fibers and the vessel alterations. So far, circulation disturbances are the most common symptoms: Wine of thirteen patients complained of this, and in fact eight of them gave this complaint as their first symptom. The degree of complaint ranged from increased sensitivity to the cold and "akrozyanose" to the Raynaud ASI 000010399 I 4 syndrome (four patients). The circulation obstruction could be judged objectively with the aid of temperature measure ments, determination of the time required to rewarm after exposure to the cold, capillary microscopy, and arm-hand arteriography. In no case did oscillography and plethysmo graphy result in a certain pathological prognosis. From this, one can ascertain that the origin of the circulation obstruction is in the periphery and not in Immediate range , of the large blood vessels. This consideration is supported by the angiographic and capillary microscopy results. Four patients with sensitivity to the cold were proven to have ampule-like widenings of the capillaries in the nail joints just as described in the Raynaud syndrome (14)* All seven patients who underwent arteriography showed pathological vessel images. The alterations ranged from a slight narrow ing of the Aa. digitales palmares propriae et communes with ^single segmentary localized closure^ to a high degree of stenosis and segmentary closures, and even to the extent of he loss of contents by the arteries in the entire length `of the finger and clear stenosis of the entire hand joints. z' After the examination until this point, it appeared that a direct relationship existed between the length of exposure and the amount of vessel damage. The most obvious x-ray results of this disease were the band-like osteolysis between Processul unguicularis and the phalangen on single or all fingers in six of the patients. ASI 000010400 5 In addition, fragmentation and border defects of the Pro cessus unguiculares could be found in six patients. It' is also possible to determine different degress of bone alter ation: in light cases only a small lytic zone is visible, and in the advanced stage the phalange is almost fully de stroyed and the Processus unguiculares mounts onto the basis of the phalanx cap-like. A full restitution of the bone is not to be expected based upon the facts at this time (23*24). Remarkable herein is the solid correlation of acroosteolysis and the club-like expansion of the end r phalanges. Thus, the 'drumstick fingers" are an expression of the lytic bone process and not of an internal disease. \ An examination of the blood building system and coagu( lation draws our attention to this remarkable finding:* all thirteen patients showed light to serious thrombopeny. The :thrombozytic count lay repeatedly between 30,000 and 119GC0/jLcJl (under a normal limit of 150,000/u&)* . In.a sternal puncture given to six patients in search for an t explanation, there resulted in no case a reference to the Obstruction of the'thrombosytopoese", osteomyelofibrosis, or osteomyelcsclerose. The other examinations showed no deviations from the norm, except for a slight reticuiocis in eight patients (between 16 and 26 %), and a slight leu kopenia in five patients (2350 to 3950 leudocytes/^JL ). Reticulosis and leukopenia may be caused by the splenomegaly in the twelve patients. At this time, it is not clear if ASX 000010401 the thrombopeny is also sc caus d, but it is probable that it deals with a turnover disturbance or an increase in disin tegration in the periphery. It was observed in the anamnese that three patients re ported recidivisic pain in the left upper abdomen and one patient reported pain in the right upper abdomen and a feel ing of fullness, as earlier diseases of "Leber and Milz," yet long-time intake of medicines or extreme alcoholism were not * discerned. However, three patients without the scleroderalike skin condition and acroosteolysis had record histories pointing to a chronic liver ailment (Esophagus varices ble ding, splenoral anastomosis;portal hypertonus; esophagus varices, splenomegaly.). The bromosulfaline retention was clearly increased, but by comparison the values for serumtransaminase and-phosphates were for the most part nothing out of the ordinary. This discrepancy could also be proven In the other ten patients. Four patients had esophagus varices, and in twelve cases splenomegaly was proven scintallgraphically. The laparoscopic and liver biopsy results of five patients, which were available to us at the end of 1972, showed remarkable agreement: surface area of the liver clearly or finely waved, capsule fibrosis, increased bloodand lymph-vessels, histologicaly a slight to clear fibrosis j of the portal system and individual cell necrosis, and slight coarse fat droplets. The result, that we could further ver- / ify at this tine let us express the following theory: 'Except ASI 000010402 I 7 for the slightly toxic alterations of the liver cells, this results from the expansion of the connective tissues in the portal system into the diffuse circulation In the liver* In advanced stages this leads to an interhepatic block (most like ly because of the hinderances in the height of the portal system, possibly similar to a sinusoidal block), with esophagus arices* It remains to be found if the splenomegaly is only is a secondary condition or if this primarily the direct .result * of toxic changes* . Of nine patients examined in the lung functions (anamnese, x-rays, .spirometry, entire body plethysmography, and blood gas analysis) after references pointed to mainly restrictive t* alterations, eight of these patients showed partial insuffi ciencies* Further research must be undertaken to determine If these disturbances can be traced back to the fact that similar changes occur in the lungs as in the collagen and elastic supporting tissues of. the skin, that is, that a * 4 beginning diffuse lung fibrosis is the cause of these* dis turbances. * ** ^ * * The Initiating Factor This paper is concerned with an industry-caused.disease, in which the symptoms include (arranged in order of most common occurrence) thrombopeny,/splenomegaly, toxic liver damage, ventilation blockage, circulation obstruction, and skin and / bone alteration. This complex of symptoms has not yet been ASI 000010403 1 8 been assigned to a known syndrome* It is unexplained etioiogically and pathogenically. Is it possible to obtain a certain insight in the etiology and pathogenesis by a comparison of our results with those previously recorded in literature? What is then possible to be the initiating factor? At a simultaneous pressure and temperature increase, liquid vinylchloride is polymerized to polyvinylchloride with _ the addition of water and various additives, depending upon the different properties desired* In different countries, independent of the additive type, the Raynaud syndrome and acroosteolysis was present in workers cleaning autoclaves* The symptoms appear so characteristic that it lead in the past year to the disease designation of "occupationallyconditioned acroosteolysis" and was advanced to a diagnosis position '28), It is not assumed that the additives, differ ing by type, country of production and methods, play an import ant role, but the harmful combination of these with the vinylphloride can not be completely excluded. Therefore vinylchloride, the substance present in the largest amount, be comes the main point of our interests* The monomer vinylchloride is pumped over a closed system of an autoclave. The exit possibilities of the gas - and thus the inhalation possibilities - consist then in more places within the pro duction process: 1* Permeability of the autoclaves (intake and offtake) / ASX 000010404 9 during polymerization and recovery processes. 2* In the discharging and opening of the autoclaves as well as In the drying process of the finished polyvinylchloride. The residual gas consists of up to 90% vinylchlorlde (6) and often leads to leaden tiredness and short-lasting disorientation in the employees. 3* From the polymer precipitation on the walls of the kettles. Therefore, from the technical viewpoint, it is completely possible that vinylchlorlde initiates the hereby described disease. Some facts are already known about the effect of vinylchloride on human and animal organisms. The narcotic effects have long been recognized (22). 'Since 1958, reports have r - peatedly been made concerning the angioneurotic obstructions and the Raynaud syndrome in workers (1, 10, 21). In the literature one finds single references to the intoxication of vinylchlorlde, wherein a reversible dizziness, light to very noticeable giddiness, disorientation, skin appearing as w .. a 2-degree burn, and lessened blood coagulation have been *<* + determined symptoms (6* 9# 11)* One worker died as a re sult of poisoning. Vlth the use of experiments involving animals, lung ,* odem, blood congestion in the lungf liver, and kidneys, * as well as decreasing blood coagulation could be proven (20). / In long term experiments it was possible to produce centra^ lobular degeneration in the liver and necrosis with foamy vacuolization as w 11 as periportal cellular infiltration (26). ASX 000010405 10 ( Recently, reports were made concerning skin, lung, and bone tumors and obstructions In the bone structure (27)* These results, based on animal experiments, lead again In 1970 to a depression of the MAK (maximum occupation concentration) to 100 ppm (13)* It is not yet known to us the regulations concerning gas concentrations at the occupational site. The symptoms related in the framework of this disease (Raynaud syndrome, toxic liver changes, obstruction in the . ' bone compositions and prenarcotic syndrome) may then be pro duced by vinylchloride, Thus, in the knowledge of the occu pational site we can express the conjecture that long term exposure to vinylchloride is at least a, if not even the -disease-initiating factor. The fact that the name "occupationally-caused acroosteolysis" hints only at a not necessarily determining symptom shows that a new name should be coined. We have proposed the designation "so-called #* Vinylchloride disease" for this syndrome because this disease, influenced by the participation of numerous organs, obtains the character of a system disease. Pathogenesis The pathogenesis is, as before, unexplained. On;the -basis of our research we discussed the theory that the disease as a pathogenetic principle in the furthest sense is caused by an obstruction on the connective tissue or the vessel connective tissue. In-addition, as our theory shows that the toxic agent is effective not only per inhalationem, but ASI 000010406 11 also perkutan, the fact exists that only uncov red main arteries exhibit scleroderma-like coatings and that the band-llke os teolysis is only found on the finger phalanges. We saw sclerOderma-llke skin alterations as well as acroosteolytosis only In workers who had worked a long period with the cleaning of autoclaves. This can perhaps be explained by the fact that 600-1000 ppm of vinylchloride could be measured in the area of the autoclave walls (5). As an indication based upon the m obstruction of the connective tissues, we saw the qualitative and quantitative alterations of the skin and the multipli cation of collagenic fibers in the portal system of the liver. The increase and expansion of the capillaries was visible by capillary microscopy and histology in the upper cutis, in addition to the peripheral circulation obstruction proved clinically, angiographically, and thermographicallyi Even the alteration of the bone (osteolysis as a result of trophic obstruction by damage to the vasa nutricia) and the lung (restrictive and obstrictive ventilation blockage) can be synonomously explained. The prognosis of the disease judged quite optimistically by earlier literature-appears quite serious to us, especially with respect to thrombopeny, "splenomegaly, and portal hypertension. According to our observations of alterations in the bone, this disease should be judged with reserve. Consequences for the Practice The triassic formation of this disease system, serious ASI 000010407 1 12 } prognosis end r lativ ly high mortality (from our investigation v certainly more than 10%) has led prevailingly youn men to sol icit us to place the following suggestions: 1 Execution of epidemologic and preventative medical experi mental tests. In our opinion, it is not sufficient any more to search for only Raynaud syndromes and knotty skin alter ations because these symptoms , as characteristic as they ar , already show the advanced stage of disease. Perhaps more ( . important, controls to determine the thrombozytic count in regular time periods should be given to all employees of PVC- producing industries. This should take workers with a con stant thronbopeny out of this branch of the industry, as this appears to be the first objective symptom, before further and more serious internal damage occurs. 2. No employment given to those with liver diseases or circu latory problems. 3 Regular gas concentration measurements in different work sites to avoid exceeding the MAK limit. Experienced tech nical improvement with the goal of greatest possible automation, andimprovement of the ventilation conditions to reduce the possibilities of gas inhalation to the lowest amount possible. if. Compensation to diseased workers and recognition of this disease as liable to Indemnity by inclusion in the list of BKVO. ^' 5* More research, especially with animals, using vinylchloride with special consideration to the skin, bones, lungs, liver, and spleen. ASI 000010408 ) 13 BIBLIOGRAPHY: Literatuc^ (1) Anghrletcu, t.t M- Otniu. f,, tlwbriMihit, L HJfp trrchi.-Do.'ii.i. afrhutaiion. Fendmnpliend'et dee Lan der Kotdrhcin-ikfetfalcti, Nr. Ill) (Weeidcutadier Vcrlag. Loin 1*44). C V, C.tm: faftmlcrjiii f 15) Juhc, S., C. Vcltman. Zur Klinile dimcD-pavngennc jtufiri bvnunulm der lug. Vmyldilnrid-ltra7.tr.cit I. Inter- Raynaud la muncuoru din tnduwna neiinnaln Sympntium der *3 rriiiirvte policlonini dr ul. Med. interna dcr dtemiadien Induitne. 27. 4. |*7Z. ue.| 21 47J. (14) Juhe S., C.-E. Lange: SaivruJermi*- (2) liubn, A. V,, A. K. Vjtiii, antge Hauiveranderungen. Raynaud- A. C. Kochetkov: On the pathogenetic Syndrom und Akr*ot'eolyt*n bei Ar- of dianget drvtlopmit due lo * lung- bcitrm dcr FVC-hertiellenden Induatrie. term eapovart to the effect of vir.yl- D11J1. med. Widir. *7 am,. 1*22. (blonde. C.g. Tr. prof. Zebu). 14 0*721. 24. (17) Jiihc S., C.-E. Lange. C. Stain. C. Vekmin: Zur Klimk der tog. Vinyl- 0| Chatelaln, A.. F. Monlluo: Un eblorid-Krankheit. Jahmragong DeundM tyndtoat d'acto-oatcolyae d'urigine Ccwlladiaft liar Arbeiumedaun, profeieionellt tr dt cuntminn nouvtllr 24.10.1*72. to France. J. Rtdiul. Eleutrul. 41 (1*47), 277. .(4) Cordirr. |. M., C. Firvtt. M. J. (It) Lange, C.-E., S. Juhe, C. Stein, C. Vcltman: Die ae-g. Vmy&htridKranldieit - une berufibrej-.grv Syatena- * Lefevra. A. Stvrin: Acnjottcnlyec aklenitc? lot. Ird. Arbcttaaed., im Ifvona cutanea xteociea diet deuv Drudt. Mtiitn ah'eetet aa nertoyapt d'jutiw dim. Cah. Altd. Travail 4 (1*44], 1. (5) Cook, V. A.. F. M. Otter, * D. (1*1 Lange, C.-E . S. Jdhe, H. J. Martejlet, R. Melicr. C. Veltaae: Leberaebiden im Rahmtn der aog. Vinyl- Dieman, H. J. Magnuasn: Occupational dilorid-Krankheit. Jahreitigung Deot- ocrooetrolyiu. It, An induarrial hygiene adie Ceaellachaft fur Arbcitimedinn tidy. Ari. envimnm. HUH 21 (071). 74. II. i. 1*7). ,220) Maatiomatteo, E., A. M. Fiaher, (4) Danatger, H.t Accidental pononing H. Chriatie. H. Daniigcr. Acute inha by vinyl (blonde. Caned, med. Aaaoc. lation toxicity of vinyl chloride to J. 12 (1*40), 111. . laboratory animalt- Amcr. ioduatr^ /(I) Dinman, *. D-, W. A. Cook, V. fcl. Vhitchouac, M. 1. Magnutun: Occupaiional a<moeol>*t(. I. An epidemiological acudy. Ardk. tnviroom. Hich 22 (1*71). 41.. Hyg. Aea.-J. 21 (1*60) )*4; aitiett in: Wallen, K. E.. R. L- Zielhuia (ad.): . Induuriat Toxiculogv and Dermatology in the Production and Froceuutg of Flatrio (EJaevier. Amatcrdam 1*44). ill Dodaon, V, N-, B. D. Diemen, M. Whitebouac, A. N. M. Near. M. J. Magrnuom Occupational acroo- (21) O'Conner, R. E.: A new occupatio nal diaecK it bom. J. ocesp. Mod. ' 12(1*701,2)4. * ataolyaii. III. A clinical anidy. Arch, oneironm. Hldi 22 (1*71), II. yJ3X) Feoplea, A. S., C. D. Leake-. The ancaihetk tciion of vinly dJon.ie. (I) Dublin, t- ]., 1. J. Vanct Occupa J. Pharmacol, exp. Ther. 4g (1*55), 214. tional hautdi aod diagnoatic aewncc. 123! Stem, C., S. Juhe. C.-E. Lange, BuBetlo No. JC (()). Bulletin No. 41 C. Velrman: Bandformige Orrvolyaen in (1*41), U.S.A. Dept. Labor; titwR ini Dafttigrr (4). den Endphalangen da Hasdikeieta. Fortadir. Rbotgtnatr. til it*73), 40. (101 Filamva, V. S,, L- J. Balakbonova, (24) Stem. G- S. Juhe, C.-E. Lange, L L Gnmaberg: Hygienic conduinni in G. Vrlttnan: SkelctTvcrZndcnmtco hti ' (be ptodsenoa of vinvl dileridc. Gig. dcr aog. Vmyliiikirid-Krankacit. Tr. prof. Zabol 1 (1*51), 4; amtre in Ronigcnpraxii, un Drudt. Public Hcalcb Engia, Abirr. 40 (1*40) No. 4, p. 4. (25) Suciu. L, J. Drciman, If. Valaekat: Contributii la atudiul imbolnavinlar (II) Karen, D. K.: Health pmblemt in produce dt donim de vtr:l. Med. dw manufacture and utc of plainer. interna (Buc.) I) (1)4)), *47. Brit. J. ioduatr: Med. 10 (1*11), Hi. arrien in: Mal.en. K. L. A. L. Zielhuia fed.); Industrial Togiiolngy and Dtemak*n in the Production and Fnarntni of Flattui (Elactwr: Amwerdam 1*44), 14). (241 Torkelaon, T. R.. f. Oytn. V. K. Rowe: The tuxicny of vi-il dilnride n determined by repeated eapotuie to laboratory animalt Amcr. iaduatr. Hyg. Art. J. 2211*41). ii, unerr in: Malian, K. E , R. L. Zie'disii led.): OB Harrii. D. K.. W. C. F. Adama: Induairijl Tuxicvlogv and Dermarology * iaaomiilriji oceurtint in men encaged in the Production and Prjutuing uf In Ike pelymtr.tanvn nf vinyl dilonJt- Flaatica (Elaevier: Amatcrdam 1*44). lit. med. |. l*47.j, 712. Vmla, F. L., A. Rigntu. A. Caputn: 0B Hrnidiler, H. (Hng.): Cciund* On.xigenk reaponae of rat akao. lunga, briteicbidliiiic Arbctftitntre. Tuulvlv- and boon to vinyl dletdc Cancer fitdi-arbt tamed nnitehe Brgnindung von Rrt. )l (1*71). 514. blAK.Wrnen (\trieg Chcnuc. Mon* htim 1*72). _^(2*} WiUon. IL H.. W. E. McComid:. C. F. Tatum, J. L. Crcedi: Ocntpational 0*1 Jacoby, H.: Ftripbiiv Durehblu- cmcaicolyaii. J. Amcr. med. Au. 201 tiinpkrenkhtiteo in SpicerI Ocr Mikro- (1*47), 177. 1 > Dr. Suianne Tiihe. Dr. C.-E. L:nge, Dr. C. Stein, Prof. Dr. C. Vtltman Uiiiveriitary-Hautkhnik S3 Bonn 1, Vrntubcrg - AS I 00001O4OQ + *0 * d* CONFIDENTIAL. Copic )by MCA. January 30, 1974 Translations Unit/7R.12.897b/','MrB/VS 8 January 1974 PVC GAS: 40 MSN TAKEN ILL Doctors say: "Very serious" Reference: KBlner Stadt.-Anzeiger, 14.12.73 EB Troisdorf - More than 40 workers at the Dynarait-Nobel Works in Troisdorf bei Siegburg have been attacked by a severe illness which is brought on by gases released during the production of the plastic polyvenyl (sic) chloride (PVC). Doctors at the Bonner Universitfftskliniken (Bonn University Teaching Hospitals), who have been studying the PVC-sickness for some time, describe it as very serious. It can, in severe cases, prove fatal, particularly in younger men. The most serious symptoms are said to be sensations of giddiness and cold, headaches, swollen finger joints, bone atrophy, difficulties in breathing, reduced blood clotting capacity and liver damage. (See Panorama) Circulation Mr G J Sleddon, DS0-320 Dr D Winter, F-11 Translations Unit, R-J/G ASI 000010410 ) Copied by MCA. January 30, 1974 Reft Weser-Kurier. No. 300, 20.12 1973. p. 11 Insidious Disease Chemical Workers threatened by Hideous Disease due to PVC Gas Poisoning Bonn Ministry sets up Special Committee of Enouirv Bonn (our own correspondent). Chemical workers directly engaged in PVC autoclave production in large chemical factories are threatened by a new and serious disease. At least 40 employees of a Troisdorf factory are reported to be poisoned by dangerous vinyl chloride gas. "A serious prognosis" for the victims, according to the Bonn skin specialist Professor Gunther Veltmann. Mortality, from PVC gas poisoning is reported to be "relatively high" and particularly serious in young male workers.* * According to the medical specialists the frightening consequences of the gas poisoning are reflected in the softening of the bones in hands and feet, enlargement of liver and spleen, severe effects to blood formation and coagulation, and as sociated grave lung disorders. The victims have increasing difficulty with breathing, and varicose veins can form in the esophagus. This previously unknown disease, according to Professor Veltmann, is "irreversible," i.e. incurable. No remedy has so far been discovered, and the only thing that can be treated is the defective organ. The victim can only look forward to in creasing disablement and insidious encroachment of the disease. * Experiments on animals are now being commenced to study the causes and course of the illness and to find antidotes. This evil disease is not even recognized yet as an occupational illness. As a result of the alarming medical reports. Federal Labour Minister Arendt has set up a special committee to in vestigate and report back. The more seriously affected victims are now claiming disablement pensions. However, they have as yet no entitlement to a pension, since this particular illness is not yet officially recognized as an occupational disease by the health authorities. * The Committee for Dangerous Raw Materials of the Federal Labour Ministry considers that r gular medical insp ction of workers engag d in plastics production is ess ntial. Guidelines ASI 000010411 1 I -2- for technical countermeasur s in respect of health hazards are also being drawn up. Local factory inspectors have already ordered individual firms to introduce appropriate safeguards. Meanwhile, the Troisdorf workers have levelled the serious accusation that they were used as guinea-pigs. One employee, aged 39, a sufferer for some 18 months, is reported to have swollen hands and feet with no more feeling left in them, and is afraid to venture on the street because of dizziness. He f first became aware of the unusual symptoms when cleaning out a PVC autoclave three years ago. Another 47-year-old chemical worker attributes his chronic liver trouble to the poison. According to Professor Veltmann, the effects of the gas on the liver resemble the liver complaints suffered by chronic alcoholics. The 160 workers on the Troisdorf autoclaves have become particularly uneasy about the situation. However, both manage ment and works council have emphasized that the employees directly involved are not really worried, in view of the fact that none has accepted the offer of transfer to other work on the site. A different explanation, on the other hand, is that these same workers are the top earners in the industry. It is they who are responsible for producing the material which is subsequently processed by their other 2,500 colleagues. PVC is one of the most widely used.plastics, with countless applications in the home and in industry, rfiowever, medical specialists emphasize that nobody can suffer ill effects due to contact with PVC products,j The only people at risk are the workers directly engaged on the plants in which the colorless vinyl chloride gas obtained from petroleum is liquefied under pressure and converted into powder in large reactor. The danger arises from the gas, which can escape during the process either as a result of leaks, carelessness, or during the cleaning of the reactors. Hrhe maximum permissible concentrations of such leakage gases have repeatedly been reduced by the responsible authorities^] According to the Troisdorf works, "nobody has yet died and production has not been irresponsibly pursued at the expense of workers' health or safety; moreover, no efforts have been spared to safeguard the interests of their employees." Hans Wullenweber ASI 000010412 1 Copi ) bv MCA January 30, 1974 Translations Unit/TR.12.89?a/EMS/VS 4 January 1974 PVC DISEASE TO BE INVESTIGATED Reference: Frankfurter Allgemeine Zeitung, 20.12.73 Bonn/Troisdorf 19 December Many cases of illness among persons employed in the PVC plant at Dynamit Nobel AG in Troisdorf have caused concern among the local population. As Dynamit Nobel AG confirmed on Wednesday, 43 workers so far have shown symptoms of the mystery illness, which is known only as "PVC disease" at present. Two foreign workers are said to have become completely incapable of working already. PVC (polyvinyl chloride) is a widely used plastic that is produced by a number of other chemical companies apart from Dynamit Nobel AG. How seriously the situation is regarded is apparent from a statement issued by the West German Minister of Labour on Wednesday to the effect that the government had instructed investigations to be carried out into the hitherto unknown causes of the disease. Details are to be laid down in January by a panel of experts. According to the Ministry of Labour, the relevant employers' association is working on the assumption that the disease is caused by vinyl chloride. It was stated that the Ministry of Labour Committee considers that operatives working in the neighbourhood of PVC autoclaves must be medically examined. When the various cases of illness became known local factory inspectorates ordered steps to be taken to provide increased health safeguards on the plant. The symptoms of the condition are unconsciousness, attacks of dizziness, changes in the hands and feet, headache and nausea. According to a report from the works in question, the first cases of physical damage to workers in the PVC plants were observed in Germany in the Spring of 1972. Dynamit Nobel have been producing PVC since 1951. The Press Section at the Troisdorf works stated that: The government industrial medical officer, in agreement with the Chemical Industry Employers* Association, has instructed Professor Rudolf Gross, who holds the chair of Medecine at the University of Cologne to examine some of the affected persons and to produce a report. 6 patients from the PVC plant have now been examined by Professor Gross at the university teaching hospital. A report on some of his findings will be issued in December. TH 12902 Translation from Der Spiegel No 50/1973 Cop? | by MCA January 30, 1974 MEDICINE Dangerous Plastic A new and deadly occupational disease has been discovered by Medical Specialists in Bonn: workers engaged in the production of PVC risk incurable diseases of the liver. Pipes and Venetian blinds, curtains and films and whole host of articles in common use are made from PVC, a hard, durable plastic which can be moulded into almost any product. German producers alone have distributed almost a million tonnes of polyvinyl chloride over the country in the last year. .. PVC has so far been responsible for the death of as yet unknown numbers of chemical workers. For the production of this much desired material, w.iich can be combined in so many different ways with plasticisers, fillers and pigments that it has become one of the leading products of the plastics age within the last twenty years, is apparently very much more dangerous than had been previously been assumed. j i Medical specialists of the Bonn University Clinics have this year diagiosed a "vinyl chloride disease" in at least 40 of the 120 PVC workers in a labouring chemical factory. However, the number of cases is probably considerably higher than this. According to preliminary comments made by the doctors this newly discovered | "occupational illness" is characterised by a "serious prognosis and e relatively ! high mortality rate in men of predominantly younger age groups". According to Prof. Gttnther Veltman writing in the "Deutsche Medizinische Wochenschrlft" : I "Certainly more than 10# as revealed by our enquiries". j 1 This occupational disease first came to the notice of dermatologist Veltman and his team in the form of characteristic changes to the skin, particularly in the fingers. However, they were soon forced to the conclusion that still worse was to be revealed by this already well-known PVC symptom : vinyl chloride harms blood and blood vessels, bones, nerves, liver and lungs. As summed up by Veltman : "A disease of the system". i j This plastics material apparently places at risk only those individuals actually present when the colourless vinyl chloride gas, obtained from mineral oils, is liquefied under pressure and compressed to form powder in the large reactors known as "autoclaves". This "polymerisation process" is necessary to produc the PVC which is then sold as ,,Hostalit" (Farbwerke Hoechst) or "Vinoflex1' (BASF): Products which are not toxic as far as the end consumer is concerned, unless, in the words of plastics experts, "Plasticisers migrate from them". Those cases in which these toxic substances have been liberated from such materials have indeed been reported for a considerable period of time. e On the other hand, the "closed system" of the autoclaves gives rise tc dangerous leakages* The Bonn Medical Specialists have been investigating "possibilities of gas leakages and associated inhalation risks" at numerous points ir the production process, YC-gas escapes when the reactors are discharged rnd opened as well as through "leaks in the autoclaves". For many years doctors have been awar of the toxic nature of the gas and its narcotic effect. Almost without exception personnel engaged on the cleaning of autoclav s complain of feeling "dopey", giddiness and headaches. For this reason the "maximum allowable c ncentration" ("MAK") of the VC gas has been repeatedly r duced. According to V ltman, however, "we hav so far not been aware of regular gas concentration m asurements being carried out on production sites." v tV O io o o o j | v- < 2) P rsonnel responsible for cleaning the autoclaves - such as the majority of the diseased chemical workers - apparently inhale many times the quantity of the acceptable tolerable dose of the toxic substances. Industrial doctors in Am rica have repeatedly measured gas concentrations of 1.000 ppm in the neighbourhood of PVC autoclave walls, which is ten times the MAK value. The symptoms suffered by the diseased Bonn workers show that the air in German chemical factories is not very much better. The following changes in bodily organs has frequently been observed after only 18 months employment : Enlargement of liver and spleen with lasting destruction to the structure and function of their cells - collective tissues proliferate in the organs. Reduced circulation in the hands due to diseased narrowing of the arterial vessels. Finger bones gradually deteriorate, and were almost completely destroyed in cases of advanced disease. Blood formation and coagulation were affected and breathing was found to become increasingly difficult. The majority of these illness-induced changes are considered non-curable by reason of the fact that the increase in connective tissues in all vital organs is ''irreversible'1. Specialists in internal diseases accordingly hope at the most for a "defective healing" in diseased livers. The chemical workers sure left with a thick-skinned and deformed organ such as that found in chronic alcoholics after many years over-indulgence in alcohol. According to Prof, Veltman, the necessary "consequence" is "compensation f r all diseased workers" and the recognition of the illness as an occupational disease. Neither he nor his colleagues have so far ventured to estimate the numbers of the victims of the PVC disease. Basic research into the medical problems of VC is also badly lagging. In the 100 year after the ability of vinyl chloride to polymerise was first discovered in 1878 - the doctors in Bonn are now demanding "experimental investigations in animals on the effects of the vinyl chloride with particular reference to skin, bone, lungs, liver and spleen".* * PIM : abbreviation for parts per million = parts (by volume) per miLlion : a measurement unit used to indicate the quantity of trace substances eg in a gas mixture. Circulation: Mr G J Sleddon Dr D Winter Translations Unit ACH/MMB 9 Jan 74 ASI 000010415 < ) Copied > MCA Translation: TR,12,91/ January 30, 1974 Ref: Frankfurter Allgemeine, Zeitung, 2 Jan 74 LIVER DAMAGE IN PVC PRODUCTION In spite of abundant warning signs no adequate supervision ' Like many other occupational diseases, the damage incurred during the production of polyvinyl chloride, or PVC, is only now, more than 30 years after the start of industrial PVC production, being fully realised. The scale of the health hazard involved in PVC production was first exposed in a publication by doctors of Bonn University Teaching Hospital (Universitfltsklinik Bonn), who found skin damage, changes in the ends of fingers and toes, as well as liver and spleen damage, in 45 workers at Dynamit Nobel AG's PVC plant in Troisdorf. According to reports by H J Marsteller of the Medical Klinik and Susanne Juh of the Skin Klinik in the "Deutschen Meaizinischen Wochenschrift" (Vol. 98, p 2311), 45 of the 120 workers in this plant have so far been exhaustively examined in Bonn. Some of these patients were suffering from skin changes, in others the examination was carried out on prophylactic grounds. Most of these workers were found to be suffering from various types of liver damage of obscure origin. In addition to enlargement of the liver, biochemical malfunctions of the liver wer detected. Histological tissue changes were finally established. Since, in spite of the diversity of the liver changes all the patients had been engaged in PVC production for 1.5 to 21 years. This can only be an occupational disease involving FVC. In 1963 circulatory disorders, inflammation and hardening of the skin, thyroid deficiency and enclargement of the liver in PVC workers were reported for the first time in Roumania. It was only after re-publication of this work in 1967 that similar observations were reported in Germany, France, England and the United States. But here the emphasis was on changes to fingers and toes. This led, according to the Marsteller and Jtthe report, to "attention being directed to the liver damage first noted in PVC production in the Soviet Union dn_ 1949". , The ecientists are making no statements about the prognosis of the PVC liver damage. Even the frequency of this illness among other PVC producers is unknown. Possibly tbe threat to personnel is heavily dependent on local working conditions. Since tbe morphological picture of these liver changes corresponds to chronic toxemia, such as also occurs from contact with chlorinated hydrocarbons, eg chloroform, the health risk could be determined by the concentration of the gaseous initial product, vinyl chloride, in the atmosphere. Since such a hazard was certainly not unforseeable, and must indeed have been expected iu vi u of the existing publications, the question arises as to whether either the vinyl . chloride concentration or the health of the workers were properly supervised in these plants. ASI 000010416