Document nkbR5Y3YEQnwNaweLq5E5Kdxa

j URL 15179 VINYL CHLORIDE by Dr. W-. D. Harris w This report is not intended as a complete treatise on vinyl chloride but is rather designed to acquaint UNIROYAL'S health related personnel with what went on at UNIROYAL in the years when we produced PVC at Painesville and vinyl chloride first, at Painesville and later in the Monochem Plant at Geismar, Louisiana. U. S. Rubber's Naugatuck Chemical Division grew almost exponentially in the 1940's. Prior to World War I, it had pro duced sulfuric, nitric and hydrochloric acids for use in the Naugatuck brass and metals industries. During World War I, shipments of dyestuffs from Europe were cut off by German submarines. Naugatuck Chemical began to manufacture aniline and later various rubber chemicals based on aniline as well as dithiocarbamates and other chemicals de veloped by The General Laboratories in New York City and later in Passaic, New Jersey. Synthetic rubber production was started during World War II and agricultural chemical sales began in a very small way at about the same time. During the 40's, research was going on at The General Laboratories and at Naugatuck on various synthe tic rubbers and plastics. While we researched our way into 08 is n u n 2- - rubber chemicals and agricultural chemicals, management decided that purchase of a plant was the preferred way to enter the rapidly expanding PVC field. The purchase of the Glenn L. Martin PVC Plant at Painesville, Ohio resulted in 1950. This plant, which started production in 1947, initially made its own vinyl chloride monomer by additions of HC1 to acetylene. The HC1 was purchased under a favorable contract with a neighboring Diamond Alkali Plant. During the 50's and early 60's volume was doubled and redoubled. Production of VC at Painesville stopped after the Monochem Plant came on stream in 1961. As was true in most companies at this time, we assumed that vinyl chloride was of very low toxicity. In retrospect, the only animal toxicology studies were acute studies aimed at its possible use as an anesthetic. Because of poor performance, fire hazard and toxic side effects, this use did not develop to any appreciable extent. Nevertheless, everyone "knew" that ex posure to vinyl chloride gas was not dangerous so long as you didn't get anesthetized. It was inexpensive so most of the re search and development effort on PVC was directed at achieving a better product for various end uses. Most monitoring was aimed at preventing fire and explosion hazards, levels approxi mately 10Q times higher than the TLX. Torkelson and coworkers at Dow conducted a six month vapor exposure study at levels T. R. Torkelson, F. Oyen, and V. K. Rowe, Am. Ind. Hyg. Assoc. J.. 22, 354 (.1961.) from 50 to 500 ppm on rats, dogs and guinea piga. As a reault of these studies, Dow recommended a 50 ppm exposure limit which. 3 they adopted in their own plants. These and other studies are% reviewed briefly in Patty and in IARC's Vol. 7 (pages 291-318 (1974)). Patty's Industrial Hygiene and Toxicology 3rd. ed. Vol. 2B. Toxicology, pages 3537-3542. John Wiley & Sons. New York (1978). Because most management people in the chemical industry had little experience in the rapidly developing field of in dustrial toxicology and because of the apparently good health experience among workers heavily exposed to VC, these early warning signals were largely ignored. ACGIH had set a TLV at 200 ppm which remained in effect in 1974. However, QSHA had adopted the 1968 ACGIH level' of 500 ppm. These levels were somewhat academic since few companies were equipped to do ade quate monitoring of worker exposure before 1974 because VC was considered to be safe at levels prevalent in the industry. ACROOSTEOLYSIS: In the early 60's, a problem began to develop in some plants in Europe and primarily at Goodrich in the U. S. (Good rich and Union Carbide were two of the earliest manufacturers of PVC resins and Goodrich had become by far the largest by the 70's.) The end bone of the fingers became flattened and in some cases virtually disintegrated. The companies set up a study group at MCA and the Institute of Environmental and In dustrial Health at the University of Michigan was chosen to conduct an epidemiological study, the results of which were published in Archives of Environmental Health (22,61-73 (1971)). Z ftis v tu n 4 The problem was confined to workers involved in hand cleaning reactors. Although the study did not prove that vinyl chloride was the cause, it was generally considered to be. In Italy, one company retained a Dr. Viola from a local university as its medical adviser. They had asked Mm to try to develop an animal model to study the acroosteolysis problem. They agreed on a long term vapor exposure study on rats at 30,000 ppm. At this high level. Dr. Viola ran into an unexpected problem -- zymbal gland tumors. All his animals died before the end of the year. He reported the results of his study at a meeting in Houston in 1970. The Environmental Health (not sure of exact title) Committee of MCA, of which UNIROYAL'S Medical Director, Dr. Jack Wolfsie was a member, invited Dr. Viola to meet with them. Cl am not sure if this was in New York or Washington.) Initially, Dr. Violals work was taken rather lightly because the dose was so high that the animals were Lethargic and did not live long. It was felt that the dose was so far removed from practical exposure as to be meaningless. Man does not have any organ corresponding to the rat ' s zymbal gland. However, during the following winters and spring. Dr. Wolfaie and I discussed the problem with each, other from time to time and became convinced that the industry should study it further to determine whether a real health problem might exist. UNIROYAL moved its corporate offices from New: York to Middlebury about July 1, 19.71, and Dr. Wolfsie chose not to move. We were without a medical director until November 1971, when Dr. J. D. Forbes took the position. In the meantime, realizing that we URL 15183 5 had lost our contact at MCA, I suggested that I be designated as UNIROYAL'S representative on a VC committee being formed at MCA. In my letter of October 5, 1971, to B. R. Leach, then Plant Manager at UNIROYAL'S PVC plant at Painesville, Ohio, I recommended an industry animal study to determine dose-response i relationships and an epidemiological study of VC exposed work ers. It is important to realize that at this time we did not know that VC was causing cancer in workers. We were just en couraging a responsible approach. There is always a tendency for others to judge actions based on later knowledge or beliefs. We did not have a representative at the November 16, 1971, VC meeting at MCA but received the minutes. I attended the December 14 meeting as a guest. During the Winter and Spring of 1972, a great deal of effort went into securing financial support for the toxicology and epidemiological studies, designing protocols and selecting contractors. We knew that an animal study was most likely in progress in Europe and we wanted to learn as much about that study as possible so that we could design a study which would further extend our and their knowledge. The minutes of the April 20, 1972, meeting listed me as a member and from that time until the closing of our Painesville Plant in late 1975 I was deeply involved. During the late Summer of 1972, ICI relayed the willing ness of the European group to impart information on the European w is n a n 6 study if suitable confidential arrangements could be made. George Best's (MCA) letter of September 20, 1972, to R. 0. Lindsell of ICI indicated that I would meet with, him in England in mid-October. When I called Mr. Lindsell, he said that they would want me to attend their meeting in Milan on October 19, which I did. My letter of October 20, 1972, to George Best describes my meeting and my visit to Maltoni's office and laboratory. At this meeting the European group advised that they could not give data but they wanted me to understand thoroughly the nature and scope of their study and invited the U. S. group to support studies aimed at rounding out Maltoni's work. They did tell me that the dosage series covered the range from 10,000 to 50 ppm and that they were surprised to find "toxicity as low as 250 ppm". From the comments made and from what I saw at Maltoni's laboratory, I concluded that Maltoni was finding what appeared to be VC caused cancer at levels as low as 250 ppm, but I had no data so could not in good conscience give this information to any government agency. If NIOSH, 0SHA, or EPA were given such preliminary information it would have been made public at once (FOI) and Maltoni would have been hounded for details, jeopar dizing completion of the study. The industry was subsequently criticized for withholding information, whereas Dr. Duffield of ICI accompanied representatives of our committee in July 1973 and gave such data as was then available to Dr. Marcus Key, head of NIOSE. He expressed appreciation and asked that we keep him informed once the study was completed. 7 There had been some delay in disclosing data to MCA be cause of concern over confidentiality on the part of the Euro peans , Upon my return from Italy, I called a meeting of management people at UNIROYAL to alett them to the possibility that VC would be found to be an animal carcinogen and if so, OSHA would be forced to drastically reduce its VC standard (500 ppm) and that it would be necessary to start monitoring workers' exposure. The Painesville Plant Management agreed to undertake the monitoring task with guidance from L. F. Dieringer and me. I also urged management to take a hard look as to whether it would be good business to retrofit the Painesville Plant in view of reactor ^ size and design. <30 During the late Summer of 1973 we got approval to purchase a Miran infrared analyzer. After it was delivered, C. B. Westerhoff came from Painesville and went with Larry Dieringer and me to S. Norwalk to be instructed in its use. In early January, I took it to Painesville and worked for a couple of days with Westerhoff to get started on monitoring. This is an elegant study instrument. When NIOSR came into the plant, a couple of months later, they were most impressed by the data which was presented to them. On January 19, Dr. Mac Roy Gasgue, Medical Director of Olin, Dr. Richard Kociba, Pathologist at Dow and Dr. Theodore Torkelson, Toxicologist at Dow, met with the European group and URL 15186 -8 - received preliminary results. They were as well impressed as I had been. Dr. Duffield of ICI attended our meeting on January 30, 1973. The next several months were devoted to developing de tailed protocols and negotiations with Industrial Bio-Test for the animal Cfat, mice, hamster) study and selecting a contractor for the epidemiological studies. Tabershav-Cooper were chosen for the epidemiological study. This study was announced on June 28, 1973, and got underway promptly. It is unfortunate that In dustrial Bio-Test which had had a good reputation over-expanded and never completed the animal study, although, we did get some preliminary results. Part of the money was recovered. The Tabershaw-Cooper study was completed and an update is currently underway by Environmental Health Associates. There is no ques tion but that VC caused angiosarcoma. This study will seek to find whether other malignancies such as brain tumor are elevated. It has been interesting to me that my recommendation not to go ahead with the Industrial Bio-Test study and to support Maltoni was vetoed by Goodrich. They are the company which has had most of the acroosteolysis and angiosarcoma. In recent years, they have really worked at improving their toxicology, industrial hygiene and medical capability and their image. On January 22, 1974, Goodrich informed NIOSE that three deaths due to angiosarcoma of the liver had occurred at their Louisville PVC Plant. Since this was one of the main cancers, iflv s n a o -9Maltoni found in his animals, the odds were overwhelming that VC was the cause. This started a process which was unprece dented in the U.S. and probably in the world. In January 30, 1974, Federal Register. OSHA began a fact finding procedure which included both written and oral comments, the latter be fore an administrative law judge beginning on February 15. This process gave everyone from scientist to laborer and general hell raisers a chance to say his piece. Scientific meetings, litera ture reviews and industry meetings blossomed everywhere. My files are extensive during this period and I have not tried to summarize them. On April 5, 1974, OSHA published an Emergency Temporary Standard for VC of 50 ppm. This automatically locked them into a six month schedule to issue a final standard. UNIROYAL presented its testimony concerning the proposed standard on June 21. It is interesting to review what we said at that time. It has held up very well in the light of subse quent findings. Although we suggested a 25 ppm standard, OSHA set the limit at 1 ppm. We will never know for sure whether any lives have been saved by this low level. The final report by Tabershaw-Cooper was submitted on May 3, 1974, but was revised several times as careful study by com mittee members enabled the authors to clarify certain issues and further records were found by Union Carbide. This enlarged the cohort. The real final report issued on January 1978. By URL 15188 10 this time, Tabershaw-Cooper had been purchased by Equitable En vironmental Health, Inc. (Their report is filed in a separate folder in my vinyl chloride toxicology file with a yellow label, "Equitable Epidemiol".) In addition to the angiosarcoma, brain tumors were in excess (12 vs. 5.9 expected). A great deal has been made of the brain tumor data but at this time we really don't know whether this is a real effect or a chance variation. Hopefully, the updated study will be more definitive. While the OSHA law is good in principle, it was written by labor oriented people from the standpoint that industry is not concerned about health and safety and will do nothing to protect the worker unless forced too. OSHA felt pressured to act quickly. While labor was pushing hard for a "non-detectable" level of exposure, we in industry advised that a finite measur able low level was essential if the standard were to be enforce able. OSHA issued its final standard on October 24, 1974, [F.R.- _39(194)35890-35898 incl.J. The main features included: 1 ppm TWA permissible exposure limit. 0.5" action level. Monitoring above action level. Regulated areas. Medical program including at least annual physical exams including history, blood parameters, etc. EPA issued its regulation on VC as a Hazardous Air Pollu tant on October 21, 1976. This standard has not affected UNIROYAL URL 15189 11 - because we stopped production of PVC prior to this. AIHA published its revised "Hygienic Guide" in February 1978 and set a TLV of 5 ppm that year. In the period following the announcement of angiosarcoma at Goodrich, VC and PVC manufacturers reviewed medical records and checked pathology of liver cancers. Cases of angiosarcoma were reported to NIOSH. For a time, NIOSH compiled this infor mation and made it widely available during the standards develop ment stage but dropped it shortly thereafter. A few pertinent documents are listed below: Compilation dated June 25, 1974, Table I listed 15 U.S. cases and 1 Swedish. Letter dated January 22, 1975, from Dr. Lloyd of OSHA to Dr. Torkelson and appended Tables. My letter of August 12, 1976, to Torkelson developed the rolling average concept and showed that VC induced angiosarcoma was not increasing after 1968. I could not justify spending a great deal of time on VC because we had dropped out of the business. Rose Kaminski's (NIOSH) letter to orkelson asking for information. TorkeIson's letter to Dr. John Stafford of ICI dated April 1, 1977. Torkelson's letter to Stafford, March 29, 1977. He gives latest NIOSH data and includes an update of my August 12, 197 6 letter. Minutes of January 11, 1978, Item 9.0 Torkelson mentions international registry 12 of angiosarcoma cases being developed by Dr. John Stafford of ICI. NIOSH update JOM 20:429-428 U-978) Torkelson updated my earlier figures 9/20/78 -- Same results. Angiocarcoma.. J. Stafford Worldwide Summaries: 1. 5/1/80 2. 1/20/82 3. 8/25/82 4. 1/17/84 During 1978 and 1979, we became concerned that we had not received a final report on IBT's animal studies. When a careful audit established that it would be impossible to get a reliable report, MCA asked for a return of part of the money. As indicated in CMA letter of November 8, 1980, we agreed to accept $110,000. The meeting of 3/18/80, attached to Dr. Shah's letter of 3/19/80 summarizes this problem. This is fur ther summarized in my letter of 3/31/80 to B. R. Leach. CSee also EPL Report, dated 5/14/80 and Bob West Associates, Inc. Report received 5/20/80. c ? ^ CD In 1979, plans were started for an epidemiological up date. A pre-publication release of a study by the Consumer Product Safety Commission was dated April 1, 1979. Rats and mice were exposed for one hour to 50, 500, 5000 and 50,000 ppm of VC. The data muddied the water but in the long run didn't 13 change things much. Comments by Dr. Jessie Norris of Dow at tached to T. R. Torkelson's letter of November 8, 1979, criti ques this study. time. Maltoni considered it a ridiculous waste of The vinyl chloride experience was a vast educational experience for: The General Public - Became more aware of OSha, NIOSH and Toxicology. Management - Became more aware that chron ic effects can be serious even though acute toxicity is low. OSHA has to be reckoned with. Scientist - Got a better insight into the kinds of data needed to thoroughly evaluate toxicity. Still can't quantify relationship between animal and human toxicity. Regulatory Bodies - Gained experience in working witc. industry groups and began to understand that industry is concerned and wants to protect its workers. Industry Group s - Learned to work more creatively and honestly with regulatory agencies. XI *2 Because of the long time from exposure till death from cancer, we will not be entirely clear of the VC problem until early in the next century. Fortunately, UNIROYAL has not-had a case of angiosarcoma. On the Basis of numbers of workers involved, we might expect one or two cases by the time all those exposed to VC have died. August 1, 1984 CHRONOLOGY OP DEVELOPMENTS m THE VINYL CHLORIDE PROBLEM . . . ... .* * , <r ' **,,r f>i ' H*'../. |. Ci.f. '&"*-*'W*&': [ Prior to the 1960*5 vinyl chloride monomer (VC) was considered * very fife chemical. At that time theta was no legal exposure limit But the American Conference of Governmental Industrial Hygienists recommended that the time neigh ted average not exceed 500 ppm* In other words, they Believed that daily exposure at this level for a normal working lifetime would do no harm to workers health. These recommendations are'1 reviewed annually* \\k - .. ; fM- * i : ", . *> " ?;V* ' /.C In 1961 the Dow Chemical Company reported on an animal study which showed some health effects on animals at this level and recommended that it Be reduced and shortly thereafter 1500 ppm was set as a "ceiling" limit, i,*, exposure over a 15 minute period should not exceed this level* . , v/`- *7 YJ`*\ In the mid-60*s a few American and European FVC manufacturere found an occasional worker who had a peculiar problem of bone degeneration in the finger tips known as acroosteolysis. A study of this condition was carried out et Michigan State funded by companies working through the Manufacturing Chemists Association. This problem seemed to*be confined to workers who were in the vessel cleaning crews in PVC plants. Careful examination of workers in our own painesville PVC plant as well as in one of our plants which used large amounts of PVC, uncovered no acroosteolysis. S' URL 16792 Following the bone degeneration problem, the Threshold Limit Value Committee, ACGIH, lowered the exposure limit to 200 ppm* Professor Viola In Italy undertook at this time an animal study in which he exposed rats to air containing 30,000 ppm of vinyl chloride several hours per day, 5 days per week for a year. In addition to some bone problems, he produced various tumors. However, the scientific conraunity did not at first consider this experiment to be relevant to plant operating conditions. At this time, there urns no knowledge of cancer having occurred in humans exposed to vinyl chloride workers, ' JL In May of 1970 Viola presented a paper in Dallas at the 10th International Cancer Congress. The MCA Enivronmental Health Committee invited him to meet with them and to explain his study and explore more carefully his thoughts on tlte subject. The feeling developed that we should carry out a more definitive aximal study and, in addition, should carry out a careful epidemiological study of the workers exposed, all under the auspices of MCA* A careful appraisal of the problem indicated that to be meaningful an epidemiological study should cover the whole U.S. vinyl chloride industry as no one company had enough workers exposed long enough to get statistically significant data* -2- MCA engaged Industrial Bis-Test Laboratory to undertake the animal study At Decatur, Illinois. Tabershav-Cooper was engaged to do the epidemiological study based solely on death records, these studies got underway in the summer of 1973 --tv Concurrent with the beginning of the MCA studies, we became aware that a European group was also carrying out an animal study. By October 1972 our toxicologist, Dr* Walter Harris, met with this group in Milan and saw the work being carried on by prof* Cesare Maltoni at Balogna. He and others who later visited Maltoni were greatly impressed with the careful and thorough work which he was doing. At this time, we did not receive any data on cancer Incidence* 'll* By mid-1973, some preliminary data was obtained from Maltoni which indicated that VC did indeed cause cancer in rats at much lower concentrations than that used by Viola* A major type of tumor observed was angiosarcoma, a cancer of the blood vessels at the liver* The MCA committee decided that NIOSH should be acquainted with all that was going on and one of the European group accompanied the MCA team which briefed Dr* Marcus Key, Director of NIOSH in July 1973. The epidemiological study was pushed as rapidly as possible. . .v.. < . ,5^ j*- * '*>.'% : It was not until late January 1974 that anyone had observed any human cancer thought to be caused by VC exposure. This was in Goodrich's Louisville FVC plant. Goodrich limedlately notified state and federal authorities. NIOSH and OSHA moved rapidly to explore the need for emergency action to protect employees* The MCA group is cooperating fully. Based on the Maltoni study* the industry was already hard at work tightening up plants and reducing exposure. 4 1 i & 9 t ia n It has now been revealed by OSHA that a Temporary Emergency Standard on vinyl chloride exposure will be issued and will specify 50 ppm as the maximum allowable concentration. Lower limits will be proposed for the permanent standard* Our Painesville FVC plant had submitted the proper records to the Tabersh&wCooper study group before Goodrich discovered angiosarcoma. A NIOSH medical and industrial hygiene team has visited Painesville and has looked carefully at the health records of our Painesville employees. Thus far no angiosarcoma .has been found. Five cases have been studied with particular attention* Two were deaths, one from cancer of the colon and one from alcoholic cirrhosis. Two cases were of disability retirement status both diagnosed as alcoholic clryhqpls. A fifth case was a terminated employee known now to have alcoholic cirrhosis. The URW is actively participating in the painesville investigations under the provisions of the Joint Occupational Health Agreement and through their industrial.hygienist, L. Beliczky. The University of North Carolina group will also participate in this study in some capacity. Our Monochem Plant at Geismar, Louisiana has manufactured vinyl chloride monomer for 13 years. This is an outdoor plant with 200 employees, only 16 of whom are exposed to low levels of vinyl chloride. An OSHA team has already visited this plant. It is not expected that this plant will have much difficulty in complying with the proposed OSHA standard. Based on present knowledge, we would not expect low level exposures experienced at this plant to generate significant health problems. ( 3- Owe Painesville plane In operation about 27 years has approximately 250 people who are exposed to varying degrees of vinyl chloride monomer. Further medical studies will be conducted to determine what, if any, significant health problems may exist In the work force. In the meantime! we have been monitoring the plant in order to define the steps needed to be taken to reduce exposure to the minimum. While ve have already made soma changes to reduce exposure, some of the others may involve engineering design, purchase and installation of equipment. All details involved in meeting the requirements of the new Health standard are under study at this time. Several of our domestic plants use Polyvinyl Chloride Resin which may contain upwards of(Jhl'of unreacted vinyl chloride* We are in the process of monitoring the various operations to determine whether any changes will be necessary in these plants in order to meet the more stringent health requirements. We know that exposure levels are much lower than in the polyvinyl chloride operations. However, they could exceed levels prescribed under the new proposed .permanent OSKA standard. Approximately 500 employees . are involved Ln these particular operations. UBW will be active participants in the investigations that will ultimately take place at aorae of these operations. Again, current medical knowledge would not indicate the develop* ment of serious health problems in these employees who may have been exposed to very low levels of vinyl chloride. Although the rules have not been promulgated with regard to discharge of VC to the community air, this area is being explored with ?A and our technical people are taking part in these discussions. It is too early to know just what the final outcome will be. , URL 16794 3/27/74 H* E, Dudrow V. D. Harris, Ph. D #, CHRONOLOGY OF DEVELOPMENTS ni THE VINYL CHLORIDE PROBLEM " Vi Prior to the 1960*5 vinyl chloride monomer (VC) was considered e very lift chemical. At that tine there was no legal exposure limit hut the American Conference of Governmental industrial Hygienists recommended that the time weighted average not exceed 500 ppm. In other words, they believed that daily exposure at this level for a normal working lifetime would do no harm to workers health. These recoomendations are reviewed annually. .V** -*0lV ' - * I7 , . .** >. A V* * fni In 1961 the Dow Chemical Company reported on an animal study which shewed some health effects on animals at this level and recommended that it he reduced and shortly thereafter 1500 ppm was set as a "calling* limit, !*, exposure over a 15 minute period should not exceed this level. v~V In the mid-fiO's a few American and European PVC manufacturers found an occasional worker who had a peculiar problem of bone degeneration in the finger tips known as acroosteolysis. A study of this condition was carried out at Michigan State funded by companies working through the Manufacturing Chemists Association. This problem seemed to*be confined to workers who were In the vessel cleaning crews in PVC plants. Careful examination of workers in our own painesville PVC plant as well as in one of our plants which used large amounts of PVC, uncovered no acroosteolysls. `V v URL 16792 Following the bona degeneration problem, the Threshold Limit Value Coomittee, ACG1H, lowered the exposure limit to 200 ppm. Professor Viola In Italy undertook at this time an animal study in which he exposed rat* to air containing 30,000 ppm of vinyl chloride several hours per day, 5 daya per weak for a year. In addition to some bone problems, he produced various tumors. However, the scientific community did not`at first consider this experiment to be relevant to plant operating conditions. At this time, there was no knowledge of cancer having occurred in humans exposed to vinyl chloride workers, JL In May of 1970 Viola presented a paper in Dallas at tha 10th International Cancer Congress. The MCA Enivronmental Health Committee invited him to meat with them and to explain his study and explore more carefully his thoughts on the subject. The feeling developed that we should cany out a more definitive amimal study and, in addition, should carry out a careful epidemiological study of the workers exposed, all under the auspices of MCA. A careful appraisal of the problem indicated that to be meaningful an epidemiological study should cover the whole U.S, vinyl chloride industry as no one company had enough workers exposed long enough to get statistically significant data. KCA engaged Industrial Bis-Test Laboratory to undertake the animal study at Decatur, Illinois. Tabershaw-Cooper was engaged to do the epidemiological study baaed solely on death records* these studies got underway in the turner of 1973. '3CA.' \ i*f>,, Concurrent with the beginning of the MCA studies, we became aware that e European group was also carrying out an animal study. By October 1972 our toxicologist. Dr. Walter Harris, met with this group in Milan and saw the work being carried on by Prof. Cesare Mai ton! at Balogna. He and others who later visited Maltoni were greatly impressed with the careful and thorough work which he was doing. At this time, we did not receive any data on cancer incidence. ' -v'; By mld-1973, some preliminary data was obtained from Maltoni which indicated that VC did indeed cause cancer in rats at much lower concentrations than that used by Viola. A major type of tumor observed was angiosarcoma, a cancer of the blood vessels at the liver. ' The MCA committee decided that HIOSH should be acquainted with ell that was going on and one of the European group accompanied the MCA team which briefed Dr. Marcus Key, Director of NIOSH in July 1973. The epidemiological study was pushed as rapidly as possible. It was not until late January 1974 that anyone had observed any human cancer thought to be caused by VC exposure. This was in Goodrich's Louisville PVC plant. Goodrich immediately notified state and federal authorities. HIOSH and GSHA moved rapidly to explore the need for emergency action to protect employees. The MCA group is cooperating fully. Based on the Maltoni study, the industry was already hard at work tightening up plants and reducing exposure. It has now been revealed by Q$HA that a Temporary Emergency Standard on vinyl chloride exposure will be issued and will specify 30 ppm as the maximum allowable concentration. Lower limits will be proposed for the permanent standard. Our Painesville PVC plant had submitted the proper records to the TabershawCooper study group before Goodrich discovered angiosarcoma. A HIOSH medical and Industrial hygiene team has visited Painesville and has looked carefully at the health records of our Painesville employees. Thus far no angiosarcoma .has been found. Five cases have bean studied with particular attention, two were deaths, one from cancer of the colon and one from alcoholic cirrhosis. Two cases were of disability retirement status both diagnosed as alcoholic cjj|hasis. A fifth case was a terminated employes known now to have alcoholic cirrhosis. The DRW is actively participating in the painesville investigations under the provisions of the Joint Occupational Health Agreement and through their Indus trial.hygienist, L. Beliczky, The University of North Carolina group will also participate in this study in some capacity. Our Monochexn Plant at Geismar, Louisiana has manufactured vinyl chloride monomer for 13 years. This is an outdoor plant with 200 employees, only 16 of whom are exposed to low levels of vinyl chloride. An OS HA team has already visited this plant. It is not expected that this plant will have much difficulty in complying with the proposed OSHA standard. Based on present knowledge, we would not expect low level exposures experienced at this plant to generate significant health problems. URL 16793 > , I i J 3~ Our Painesville plane in operation about 27 years has approximately 250 people who are exposed to varying degrees of vinyl chloride monomer* Further medical studies will be conducted to determine what, if may, significant health problems may exist in the work force* In the meantime, ve have been monitoring the plant in order to define the steps needed to be taken to reduce exposure to the minimum. While we have already made some changes to reduce exposure, some of the others may Involve engineering design, purchase and installation of equipment* All details involved in meeting the requirements of the new health standard are under study at this time* Several of our domestic plants use Polyvinyl Chloride Resin which may contain upwards of(0*^'of unreacted vinyl chloride. We are in the process of monitoring the various operations to determine whether any changes will be necessary in these plants In order to meet the more stringent health requirements* We know that exposure levels are much tower than in the polyvinyl chloride operations* However, they could exceed levels prescribed under the new proposed .permanent OSHA standard. Approximately 500 employees . are involved in these particular operations* OBW will be active participants in the investigations that will ultimately take place at some of these operations. Again, current medical knowledge would not indicate the develop* went of serious health problems in these employees who may have been exposed to very low levels of vinyl chloride. Although the rules have not been promulgated with regard to discharge of VC to the community air, this area is being explored with EPA and our technical people are taking part in these discussions. It is too early to know just what the final outcome will be. . URL 16794 3/27/74 D, E* Dudrow V, D, Harris, Ph. D ''TLL^-v aikesville air sauplpk) frogsIu* Suaaary of Results to Date & lj MEDICAL DEPARTMENT A program to sample and analyse the atmosphere la the work* lag areas of thfplant where employees night be exposed to moaner tapers was began In Deeaaber* 1572, using ssnpling equipment brought to Raines* ville by *>** V* D# Harris# Purchase of our oun saanpllnt equipoeai and nee chromatograph columns has, with the assistance of sampling by the Process Ebglaeers, resulted in a norm detailed surrey of etnocpherio composition# The data are presented In the attached table# Due to priority given to. a TUP sampling program for the past several months* the chromatograph has not boon available such of the time to run analyses for vixyl chloride In the atmosphere# It Is pi that a second chromatograph will be purchased to allow each instrument to be dedicated to a single use* This will avoid the excessive change* over time currently encountered when switching from one column to another# Also tabulated below are data obtained on vapor samples in and around curtain pieces of equlpmastt where esplodfw mixtures sight develop# This work was done at the request of the Vinyl Chloride Safety Association# The lover explosive Holt for vixgrl chloride la i& ty vol* voao or 82,500 ppm by might in air# Rone of the areas sampled shoved any danger from reaching the lover explosive limit* The TX3T for vinyl chloride was exceeded in only one area where personnel wort* That was inside an SD reactor during cleaning# This result cannot be said to be typloal* Other areas over the 200 ppm TLV were tank and diyer exhaust streams where personnel are not located# . The TUT for viiyl acetate was grossly exceeded in the ares around the Derrick screen while miming Karrinol 56# As is the ease with reactor cleaning, however, personnel are in this atmosphere for a relatively short time# The TLY for THF was also greatly exceeded In the area around the Hotothem ami again this is not an area uotiially populated# URL 2 3 |g g C 3# tfESTBiarafT^ CBUYwp Attachment CCf ERL ICE CHS HAH TO7 HCJ OJH MC HH CJU 4DP ^Sr# V* D# Harris -- Oxfoxd " * ;' . < . .. . I . - . - SICH'IZ I03A7XCW SD Reactor, SD Reactor, - Approxi fire feet from open mnhole - Approx* six inches freta open mnhole SD Reactor, SD Reactor, SD Reactor, Three feet inside after jetting a:jd air purjlng Three feet inside after jetting and air purging duriug nnual cleaning T/ree feet Inside after r.rrm-^ *1 nat?rTn<^ SD Process,- Corposite air on second finer SD Procrv^ Cwpo35tc sir cz first floor SD Slurry Tank,. One foot chore open (Pen 1/izuus) raahole SD Sl.orry Taefc-; Cue foot inside open (Fsr, narifcclf Vast a East DATE 12/13/72 12/13/72 2/15/73 12/13/72 2/15/73 5/10/73 12/13/72 SAo/73 5/10/V3 2/27/73 2/27/73 ii/10/7:; t/U/*U LA3/73 LAj/li lA?A3 YIHTL CHLORIDE pen 103,8 ' 30*6 6L.S 20/1 18 5075 i 1*7 -<1 <1 2 3 C?8 \I77 IS U R i- 23200 SD Centrifuge, Ccsposite in area LA0A3 ),/UA3 L/13/73 l 2 2 SD Dryer, Inside exhaust duct V ?A3 1/10/73 L/13/73 lBlt 219 210 SD Badger Plastlsol Reactor, Bowen XX Derrick, Boven IX Baggap, Roto them, four foet abort spout At open nsnhole after Jet flush Mcnrinol-56 L/U/73 L/13/73 L/19/73 3/W73 e 12 9 0 3 Feet Horth of * (line shut down) One foot South of 3/15/5 L/ 6/73 3/15/73 10 739 -a. <41 t0 Two feet Ilorth of 3A0A3 26 1L?6 'lover expinsi. re UitL' i 3 SuSCOpjn toiti^ CBLXsvp URL 16821 With the advent of the Occupational safety and Health Administration, industry in the United States entered a new era of awareness about possible harmful effects from excessive exposure to chemicals. This does not mean industry was negligent prior to OSHA. In fact, many companies have had excellent programs in this area for years. Others, however, did not. Furthermore, the long-term subtle effects of some chemicals in this relatively young industry are only now coming to light. Nevertheless, once industry becomes aware of a problem, it. has an obligation to take action for the future. Vinyl Chloride fits into this category. Because it is so widely used, this chemical has received much attention lately. While one can argue the details of the proposed standards (see February, 1975 issue) everyone recognizes that the primary goal is to protect the worker from any serious health hazard. In the following paragraphs Uniroyal discloses the program being implemented in its plants that manufacture and process vinyl chloride. This does not imply that this is a perfect program or the best in the industry, of which Uniroyal represents only a small segment. What is intended is a picture of how industry has developed a program by following five basic steps: (1) Recognition of a hazard. (2) Careful monitoring to locate sources of exposure. (3) Reducing exposure to lowest possible extent. URL 16822 (4) Frequent monitoring to insure that the plant is operating under optimum conditions, (5) Careful physical exams with special emphasis on tests believed to be indicative of possible exposure effects. All of the above recognize that we are still learning and that further changes may be necessary from time to time, ****** The Uniroyal program began almost immediately after B.F. Goodrich announced that vinyl chloride might be the cause of angiosarcoma, a rare liver cancer found in some of its employees. At first, all areas of Uniroyal's vinyl chloride plants underwent extensive monitoring with a continuous infrared monitor equipped with a chart recorder. Once a source of exposure was identified, technicians and engineers immediately tried to reduce or eliminate emissions. In some instances, the solution was simply fixing or replacing a leaky valve. Other spots required better ventilation, such as removing wall sections or installing fans to increase circulation. Major engineering changes have taken place in cleaning the vessels where vinyl chloride is converted into polyvinyl chloride. Traditionally, this has been the area of highest concentration of fumes. Since some vinyl chloride escapes polymerization, steps have been taken to reduce these vapors before the vessel is opened. The insides are steamed down, washed out and aired with high-pressure water hoses and vacuum pumps The attached Vinyl Chloride Fact Sheet is a summary compiled by L, F. Dieringer, Corporate Industrial Hygienist, Uniroyal Inc,, Oxford Management and Research Center, Middlebury, CT. This has been aubmitted for publication by Dr, Walter D. Harris, Chairman, Health Committee, Rubber and Plastics Section. O'J * FACT SHEETRubber And Plastics Section Vinyl Chloride *n Uu nuU/v*f $j^dCL* On October 4t OSHA published a standard on vinyl chloride, This fact sheet ie specifically designed for use by small PVC fabricators Mho presumably have very Ion vinyl chloride concentration. The first step is to carefully monitor worker exposure by pulling a > Jk***-J' T ensured volume of air through a charcoal tube or pumping it into a plastic bag and analysing in a gas chromatograph. rlf eightnhour til weighted average levels are less than 0.5 ppm r* t in higher exposure* standard carefully in light of your operation An outline of the essential features follows: 1. Scone and Applications 6 b it "WO 1910.93q-(a)(2) - The standard is applicable to the manu facture , reaction, packaging, storage, handling or use of vinyl chloride or polyvinyl chloride, but does not apply to the handling or use of fabricated products made of polyvinyl chloride* 2. Permissible Exposure Limit (c)(1) and (c)(2) - The standard seta an exposure limit of 1 pert per million over any 8-hour period (time-weighted average), and a ceiling of 5 pmrtm per 'million averaged over any period not exceeding 15 minutes. 3. Action level (b)(lT - wrtd for u "action ltwl" of 0.5 pp, TWA, OM-balf of th. pmdtwiU. xpoanr* liait. Wh*r* Initial monitoring Indicates vinyl chloride exposures are between 0,5 *ad 1*0 ppm, fabricators are required to do more extensive monitoring and have a medical surveillance program for employeea so exposed. Where monitoring demonstrates no employee is exposed in excess of 05 ppm TWA, employers are exempt from monitoring and medical surveillance^ /rr/'^Tw/'s // d fir* prat+ss <r**+**>*? , v'/l'c.fi rfi*.** -/*<< /* a /*)***/<& k* Monitoring ,A T*>* 5/ (d)(1) - An initial monitoring program is required to deter mine whether any employee exposure is above the action level* (d)(2)(a) - Monthly monitoring ia required where employee exposure ia in excess of the permissible exposure limit* 5* Regulated Area ()(l)(i) and <e)(l)(ii) - Defines regulated area as area where VC or PVC manufactured, reacted, repackaged, stored, handled or used; and vinyl chloride concentrations exceed the permissible exposure limit* (e)(2) - Access to regulated area limited to authorized persons* A daily roster required for such persons entering this area* 6, Method of Compliance (fXX) and (f)(2) - Where feasible engineering and work practice controls will reduce exposures blov the per missible levels, they must be instituted* .Where such controls will not reduce exposure below the permissible limit, they must nonetheless be implemented to reduce exposures to the lowest practicable level and be supplemented by the use of respirators to provide the necessary protection. (f)(3) - A plan for achieving control by engineering and work rj practices where hazardous exposures occur, must be drawn up, be updated at least every six months, and be made available upon request to QSHA and NIOSH representatives* ^ 13 >%'iini n.--a> *1^ Si .I O S'iU W 1 whose exposure does not exceed 2$ ppm, may decline to use the respirator, in which case the employer is not obligated to require its use* During this period, each employee who chooses not to wear a respirator shall be informed at least quarterly of the hazards of vinyl chloride and the purpose, proper use and limitations of respirators* (g)(3) * Where respirators are used a respiratory protection program meeting the requirements of 1910*13^ must be established* (g)(4) - Specifies types of respirator depending on vinyl chloride concentrationi Not over 10 ppm - Type C supplied air respirator, demand type, with half face piece or chemical cartridge respirator with organic vapor cartridge providing a service life of at least one hour. is s u ib n - 3- Not ov#r 25 ppm - Powered air-purifying respirator with hood, helmet and full or half face piece or gas mask, either of which provide a service life of four hours* (g)(6)(i) - Where air purifying respirators are used* canisters or cartridges must be replaced prior to expiration, of their service life or the end of the ahift in 'which"'' they are first used. (g)(6){ii) - Where air purifying respirators are used a continuous cnonitoriug and alarm system must be provided where concentrations could reasonably exceed the allowable concen tration for the respirator in use. 8. Training (j) - Requires that employees engaged in vinyl chloride or polyvinyl chloride work be made aware of the carcinogenic hazard, emergency procedures, need for noni taring, proper use of respiratory equipment, and purpose of medical surveillance. 9. Medical Surveillance (k) - Describes the medical surveillance program required for employees exposed to vinyl chloride if their exposure exceeds the action level. Ck)(2) - Scaminations are required every six months for JL*jL employee^ snmlcygd in yiny| chloride or polyvinyl chloride manufacturing'for all others* (k)<4) - A statement of eaoh employee's suitability for continued exposure to vinyl chloride including use of pro tection equipment and resptratora-j shall be obtained from the examining physician after each examination* A copy of this statement most be given to the employee* (k)(5) - Employees whose health would be materially impaired by continued exposure, must be withdrawn from possible contact with vinyl chloride. 10. Signs and Labels (1)(1) - Entrances to regulated areas must be posted with legible signs; CANCER - SUSPECT AGENT AREA AUTHORIZED PERSONNEL ONLY \*f U 11. Records Co)(2) * Requires that records of monitoring, medical records and authorised personnel rosters, he made available upon request for examination, and copying to authorized representatives of OSHA and NIOSH. Describes what information is required in the monitoring record. Specifies that monitoring records and daily roster sheet of authorized personnel must be maintained for at least 30 years, and additionally that medical records must be maintained for an employee's employment plus 20 years or 30 years, whichever is longer. (a)(4) - States that employees or their designated representative shall be provided access to examine and copy records of required monitoring. <m){6) - States that upon written request of any employee, a copy of his medical record must be furnished to any physician deaignated by the employee# 12. Reports (a)(1) - Requires that not later than one month after estab lishment of a regulated area# the OSSA. Area Director must be provided information as to the address and location of each establishment having one or worm regulated areas, and the number of employees in each regulated area during normal operations* (a)(2) - Within 10 working days of monitoring which discloses that an employee has been exposed, without regard to the use of respirators in excess of the permissible limit, each such employee most be notified in writing of his exposure measure ments and the steps being taken to reduce the exposure to within the Unit. 13* Effective Date The provisions of the vinyl chloride standard becomes effective January 1, 1975* C -r* C-.n ^