Document B9x2j4Q3VbLmKn25yQq9jOy8

* i <* '//- lMlL&srnA&' Managers' Notice No. 940 February 15, 1974 Subject: LOUISVILLE HEALTH PROBLEM The attached news release and text cover a statement by Mr. A. Vittone on the background of our health problem in Louisville. It was made earlier today in Washington at a fact-finding hearing called by the Occupational Safety and Health Administration of the U.S.Department of Labor. /mis Distribution: Cleveland Office P. J. Weaver Director of Industry Affairs B.F.Goodrich Chemical oo BFG34955 FOR RELEASE FEB. 15, 1974 WASHINGTON, Feb. 15 -- B.F.Goodrich recomnended today that new safety standards and work practices for the greater protection of employes in polyvinyl chloride production operations should be developed through regular rule-making under Section 6(b) of the Occupational Health and Safety Act. Anton Vittone, Or., president of B.F.Goodrich Chemical, a division of The B.F.Goodrich Company, detailed the firm's views in a statement prepared for a fact-finding hearing conducted here today by the Occupational Safety and Health Administration (OSHA) of the U.S. Department of Labor. The hearing was called following the Company's reports last month that it had discovered and was investigating the possible occupational relationship of the deaths of four former polyvinyl chloride (PVC) production employes from a rare type of liver cancer, angiosarcoma. "Our discovery of four deaths from a rare type of liver cancer among employes at our Louisville plant was, to our knowledge, the first evidence indicating a possible relationship between human angiosarcoma and chlorinated hydrocarbons used in the production of polyvinyl chloride resins," Vittone added. The four men were employed at the Company's Louisville (Ky.) PVC operations. They were long-service employes with an average exposure of 19 years to vinyl chloride and other secondary chemicals in PVC production. Vittone emphasized that the Company's efforts to maintain a safe working environment over the years have "resulted in decreasing levels of exposure with time." (more) BFG34956 A-298 LITHO. IN U.S.A. 2- - He said the Company independently and through the Manufacturing Chemists Association had stepped up its precautionary safety activities and research after European studies indicated that tumors could be produced in rats at exposure levels far above those prescribed for PVC plant working conditions. Through these and other safety efforts, Vittone added, the Company has reduced exposure levels in all its PVC operations below 50 parts-per-million, equivalent to five one-thousandths of one per cent weight in the air, on a time-weighted average. He said this improvement was made through the use of new equipment, safety education for employes and the Company's development of advanced monitoring systems. Upon discovery of the four deaths of angiosarcoma of the liver, Vittone said he and other top corporate officers "inspected the Louisville plant to observe current work practices and exposure levels." As a result of these inspections and consultation with medical advisors, he added, the Company concluded that "the existing situation warranted continued operation of the polyvinyl chloride facility." The current situation was also discussed with plant employes, union repre sentatives and government officials, he added. The veteran chemical manufacturing executive said Goodrich "will do all it can to protect the health and safety of its employes." He said the Company has reliable monitoring procedures which are being improved and that most interim work practices recommended recently by the National Institute of Occupational Safety and Health are being implemented at the firm's five PVC plants and one vinyl chloride production facility. (more) BFG34957 -3Vittone also said the Company's medical representatives are working closely with government and other medical authorities to specify the best possible medical screening and testing procedures for PVC production workers. He also reported that the Company and its medical consultants are analyzing the results of an extensive liver function testing program among all its PVC workers. Vittone said it would be premature to report specific results or to provide any statistical analysis of the correlation with chemical exposures until a medical review is completed. Vittone said the Company has found no other cases of angiosarcoma in its preliminary review of available medical records of deceased-employes and retirees from the Louisville plant and the Company's other polyvinyl chloride and vinyl chloride monomer production facilities. This review is continuing. - 0- 2-1574 BFG34958 24802CO4 Statement by Anton Vittone, Jr. Division President B. F. Goodrich Chemical Company* 6100 Oak Tree Boulevard Cleveland, Ohio 44131 Before a Fact-Finding Hearing on The Possible Hazards of Vinyl Chloride Manufacture and Use for The Occupational Safety and Health Administration February 15, 1974 U. S. Department of Labor Washington, D. C. *a division of The B. F. Goodrich Company BFG34959 s o c e o s fc i i TESTIMONY FOR FACT-FINDING HEARING FOR OSHA, C&'L.UE.'D BY OFFICE OF SECRETARY OF LABOR, FEBRUARY 15, 1974, WASHINGTON, D. C. My name is Anton Vittone, I am president of B.F. Goodrich Chemical Company, a division of The B.F.Goodrich Company. Our headquarters are at 6100 Oak Tree Boulevard, Cleveland, Ohio (44131). I have a prepared statement, from which I will now read and submit for the record of this hearing. With me to assist me in answering questions which may follow this presentation are Maurice N. Johnson, M. D., director of environmental health; Dr. Roger W. Strassburg, director of environmental affairs, and L. B. Crider, senior scientist and specialist in analytical chemistry and monitoring systems -- all of B. F. Goodrich. Their biographies are attached to our written paper. Over the years, our Company has sought to maintain a safe working environment through two basic means -- containment of potentially or known toxic materials during the manufacturing process and, secondly, protection of our employes through work practices, education and equipment. (more) bFG34960 9Q0ZQ8K! I -2- Our efforts to maintain a safe working environment have been in keeping with then known scientific information or data relating to levels of exposure, which has resulted in decreasing levels of exposure with time. Our recent discovery of four deaths from a rare type of liver cancer among employees at our Louisville plant was, to our knowledge, the first evidence indicating a possible relationship between human angiosarcoma and chlorinated hydrocarbons used in the production of polyvinyl chloride resins (PVC). Our confirmation of the significance of this new evidence convinced us that we should report it to our employees and to the Federal and state agencies with primary scientific responsibility for occupational health. Our statement today will focus on what we have learned about the four deaths at Louisville and our knowledge of previous toxicological data. We will also summarize our program to further safeguard employees now on the job through increased containment of vinyl chloride in processing and reduced worker exposure during all phases of the operation. The B. F. Goodrich Company began commercial production of polyvinyl chloride resins and compounds in 1937. We currently operate five such plants -- at Louisville, Kentucky; Avon Lake, Ohio; Long Beach, California; Henry, Illinois, and Pedricktown, New Jersey, and a vinyl chloride monomer plant at Calvert City, Kentucky. Approximately 1,700 of our employes are engaged directly in these processes. The Louisville, Kentucky plant is the oldest of our operating polyvinyl chloride resin plants having initially started production in 1942. We supply finished resins and compounds to about 2,200 domestic customer plants. (more) LQQZaQVi BFG34961 f -3- The Technologies Involved in the Production and Use of Vinyl Chloride There are two types of vinyl chloride monomer processes: acetylene based and ethylene based. B. F. Goodrich has operated both types. Prior to the early 1960's, our principal process for vinyl chloride involved the reaction of acetylene and hydrogen chloride using a Mercuric chloride catalyst deposited on carbon. Starting with a pilot plant at Louisville in 1957 and culminating in a petrochemical complex at Calvert City in 1964, we converted to our present ethylene based vinyl chloride process. This consists of three operations: (1) reaction of ethylene with chlorine to produce ethylene dichloride, (2) thermal cracking of ethylene dichloride to produce vinyl chloride and hydrogen chloride and (3) reaction of hydrogen chloride with more ethylene in the presence of oxygen to produce more ethylene dichloride. The latter process is known as oxychlorination. Significantly, the vinyl chloride monomer, produced in both processes, is distilled to yield commercial vinyl chloride with 99. 9% purity. The purified vinyl chloride is either pipelined as a liquid under pressure to an adjacent consuming plant or transferred to pressurized tank cars for shipment to other polyvinyl chloride resin plants. There are four types of polyvinyl chloride processes: suspension, emulsion, mass and solution. B.F. Goodrich Chemical uses the first three types with over three quarters of its production being by the suspension process. The steps in .the process for suspension are: - Vinyl chloride monomer is received at the plant in pressurized tank cars as liquid. It is transferred to storage tanks and then piped in a closed system to reactors. BFG34962 (more) CP B It -4- - Water, suspending agents and catalysts are added to the reactors. - Polymerization is conducted at controlled temperatures. - Unreacted monomer is recovered and recycled to the process. - Water is centrifuged from the stripped polymer slurry and the wet polymer cake is dried. - Dried polymer is bagged or siloed for bulk shipment or transferred to compound operations. The emulsion PVC process differs only in the types of emulsifiers and catalysts used in the reactor. - Most emulsion PVC processes in our plants are followed by spray drying of the emulsion. The mass PVC process differs primarily in that it is anhydrous -- no water is used in polymerization. After unreacted monomer is recovered, the dry powder is packaged. Compounding In all of our PVC production plants, we convert part of our resins into compounds in powder or cubed form. This compounding operation is the next step toward the finished products. - PVC powder is mixed with stabilizers, lubricants and, in some cases, plasticizers in powder mixers of various types. - The powder mix is fluxed in internal mixers and subsequently diced or pelletized before packaging for shipment. B. F. Goodrich Toxicity Experience In connection with these processes, our Company has had some experiences that we want to review with you in order to complete your understanding of certain factors that prompted us to interpret the most recent events as we did. (more) 6 Q 9 Z Q 8 frz BFG34963 ' 'I -5- In mid-196'4, Dr. John L. Creech, our Louisville plant physician, reported that an unusual hand problem had developed among a few employes who entered the polymerization reactors to manually remove the build-up of solid PVC from the reactor walls. This was the first time we encountered a problem anything like this. Dr. Creech's observation was found to confirm European published reports of a similar problem. We called a meeting with other PVC manufacturers to review the situation and participate with them in an extensive research program through the Manufac turing Chemists Association. We then cooperated in a worldwide investigation of what came to be known as the "hand problem" or acroosteolysis. Our employes were advised of the problem and a continuing monitoring system of hand X-rays was established at all our plants. These studies of the hand problem correlated only with manual cleaning of PVC reactors. Despite the lack of conclusive evidence as to a chemical cause of the hand problem, we initiated an aggressive program to reduce this type of exposure. Goodrich developed a hydraulic reactor cleaning process which is used on all our reactors. The use of hydraulic reactor cleaning reduced substantially the number of entries into reactors, and thus the manual hand effort as* well as the exposure to vinyl chloride. In the past several years we have observed no new cases of the hand problem. In May, 1970 Dr. P. L. Viola, of Rome, reported the appearance of tumors in rats exposed to 30, 000 ppm of vinyl chloride vapor in inhalation studies. This level is close to the lower explosive limit of vinyl chloride vapor. (more) QWZQ8frZ BFG34964 -6- Nevertheless, knowledge of this published information caused the MCA Vinyl Chloride Task Force to initiate a suitable protocol to determine whether tumors could be induced at levels of exposure above or below the 500 ppm maximum standard then in effect. In conjunction with the development of this protocol, the MCA task force learned of similar animal research which had been initiated by some European PVC manufacturers some time after Dr. Viola's report. The MCA animal test program began in Sept. , 1973. In addition, the MCA program was expanded to include an industry-wide epidemiology study now under way. In January, 1973 we intensified air sampling analysis in all our plants to determine more accurately the levels of vinyl chloride monomer exposure. We soon learned that commonly used air sampling techniques were inadequate for fast measurements at low levels for extended periods of time and for determining the cause of any increase in level. Therefore, we investigated all other monitoring techniques, including those being used in other companies, and decided that we needed to develop our own advanced system which would be capable of monitoring at very low levels and over extended periods of time. While we had been concentrating on reduction of any process loss of vinyl chloride for years, we began a series of special plant manager meetings in mid-1973 to minimize worker exposure to vinyl chloride, to discuss new monitoring systems and to put into effect new work practices. We established an interim goal of 50 ppm maximum exposure and are working toward lower levels. (more) o0) N O BFG34965 -7- Louisville Situation In the spring of 1973, Dr. Creech believed that he was observing among some employes an increasing incidence of symptoms normally associated with possible liver ailments. He discussed his concern with Phillip H. Lawrence, manager of the Louisville plant, and recommended that liver function tests be initiated among certain groups of the plant's PVC employes. The Company's newly appointed director of environmental health. Dr. Maurice N. Johnson, who is with me today, subsequently went to Louisville and started the testing program involving 271 employes. The tests, which were completed in early December, 1973, showed that 55 employes had some evidence of slight liver abnormalities. Because of the known at-" limitations of liver tests, these results were not in themselves a major cause for concern. On December 18, Dr. Johnson again visited the Louisville plant. He consulted with Dr. Creech on these results and they agreed to retest those employes showing any indications of abnormality. These tests have just been completed and are now being evaluated. In this meeting. Dr. Johnson was informed by Dr. Creech that he had recently learned that an employe died in March, 1973 of angiosarcoma of the liver. Dr. Creech also reported that this rare type of cancer prompted him to review medical records concerning another employe and former patient who died of liver cancer in 1971 and that review confirmed it was an angiosarcoma. It was then that s?- ooo Dr. Cree h confirmed his recall that the 1971 death was also caused by angiosarcoma^ G>- of the liver. Because of Dr. Creech's growing BFG34966 (more) i -8- concern and Dr. Johnson's awareness of other pertinent toxicological studies, they reviewed available medical records in the plant and found that another employe had died of an unknown type of liver cancer in 1968. They also learned that another employe was critically ill with a diagnosis of cirrohsis. This man died following day. Dr. Johnson returned immediately to Akron for a special meeting with top corporate officers at which the developments at Louisville were reviewed. The decision was made to begin an in-depth investigation with the assistance of out standing consultants in the field of industrial medicine. Dr. Johnson contacted Tabershaw-Cooper Associates, Inc. , of Berkeley, California, because of their reputation and also their involvement in the MCA work that was mentioned earlier. Dr. Johnson met with Dr. Irving R. Tabershaw in California on January 14 and 15 to review all the information then known to the Company. Before returning to Akron, Dr. Johnson learned that the cause of the third death, which had occurred on December 19, was angiosarcoma of the liver. Another in a series of top management meetings was held on January 18 to discuss these developments. Dr. Tabershaw flew to Akron for a meeting with corporate and divisional officers on Sunday evening, January 20. Because of the possibility that these deaths from a rare type of liver cancer might be work-related, the decision was made to inform the Occupational Safety and Health Administration (OSHA) through the Kentucky Department of Labor and the National Institute of Occupational Safety and Health (NIOSH), as well as to provide the essential information to our PVC employes, union officials and the public. (more) 4* & o BFG34967 -9- The initial meeting with NIOSH took place in Washington on January 22 after Doctors Johnson and Tabershaw returned from a visit to the plant and consultatio with Dr. Creech in Louisville on January 21. The notification to OSHA through the Kentucky Department of Labor was made in Louisville by Doctors Johnson and Tabershaw on January 23. A public statement was also released by the Company on January 23. A second statement was issued to the news media on January 29 immediately after it was learned that a review of autopsy records confirmed the cause of the 1968 death as angiosarcoma of the liver. During this period, Harry B. Warner, president of B. F. Goodrich; Thomas B. Nantz, executive vice president, and I held private meetings with the families of three of the deceased employes. On the same day, Messrs. Warner, Nantz and I inspected the Louisville plant to observe current work practices and exposure levels. After these observations and consultation with Doctors Johnson and Tabershaw we concluded that the existing situation warranted continued operation of the polyvinyl chloride facility. Epidemiological Studies We have actively supported and participated in both dnimal and epidemio logical studies through the MCA's Vinyl Chloride Task Group of its Occupational Health Committee. Because of recent developments, we have expanded the scope of our part of the MCA epidemiology study in order to obtain as in-depth a study as possible of\^ employes exposed to vinyl chloride and related chemicals. (more) Q? N Q BFG34968 -10- A The deceased employes had an average exposure of approximately 19 years to vinyl chloride and 10 years to vinylidene chloride. They also had variable exposure times to such volatile organic chemicals as vinyl acetate, methyl acrylate, ethyl acrylate, methanol and chlorinated solvents. It would be premature to report on the liver activity tests now in process at all our PVC plants or to provide any statistical analysis of the correlation with chemical exposures. We can tell you that no other cases of angiosarcoma have been found in our preliminary review of death records of employes and retirees from Louisville and our other plants. This review is continuing. Summary We have attempted to provide information with respect to our findings of four cases of angiosarcoma of the liver of deceased employes of our Louisville, Kentucky, plant which have brought about this hearing. With respect to Item 6 of the agenda, i. e. , "whether the available information warrants the issuance of an Emergency Temporary Standard, or the commencement of a regular rulemaking under Section 6(b) of the Occupational Safety and Health Act, " we recommend that your Agency proceed with the regular rule-making procedure tinder Section 6(b). We will do all we can to protect the health and safety of our employes. To help achieve these ends, we have brought exposure levels in all our operations below 50 ppm on a time weighted average and are working towards lower levels & of exposure. Our plant monitoring procedures are reliable and are being improvj sWe are i. the process of providing liver function tests to all exposed employes. BFG34969 (more) -11- We are implementing most of the temporary precautionary procedures recommended by NIOSH on January 31 at all plants as rapidly as possible. Several recommenda tions will require further clarification and discussion with NIOSH before implementation. Our Medical Department is working closely with government and other medical authorities to specify the best possible medical screening and testing procedures. In summary, the clinical evidence associated with the deaths of four of our employes identifies the need for scientific inquiry beyond the experience of any one company or industry group. -0- BFG34970 (D& CV