Document 06y2mr3xdJGZxzwny8E3dEyKd

. .4 t k MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON. D.C. 20009 (202) 483-6126 /_ AUG 2 8 1974 August 26, 1974 To: Technical Task Group on Vinyl Chloride Research Vinyl Chloride Research/Inhalation Management Group Subject: Senate Hearings on Vinyl Chloride Gentlemen: The Senate Committee on Commerce, Subcommittee on the Environment, conducted overview hearings on vinyl chloride, Wednesday, August 21, chaired by Senator John Tunney. Dr. T. R. Torkelson presented the attached statement for MCA describ ing research programs that MCA has been involved in. Other participants are listed on the enclosed witness list. Two developments are noteworthy. One is the announce ment by EPA that it proposes to control vinyl chloride as a hazardous air contaminant under section 112 of the Clean Air Act, as further noted in the following comment from Leonard Eiserer's column in the August issue of the Journal of the Air Pollution Control Association: "EPA'S INTEREST IN VC as a hazardous air pollutant has been heightened by reports trickling in that VC coming from industrial plants may be harmful to health of downwind neighbors. New data from Connecti cut show two cases of people who lived in vicinity of VC plants and who died from liver cancer. Also reported were two deaths of workers who had only mar ginal exposure to VC. One man worked as an account ant in a plant that produces PVC resins, the other in an electrical products manufacturing plant. Ralph Nader's Center for Science in the Public Interest, in petitioning EPA to declare VC a hazardous air pol lutant, as expected, told EPA that "economic factors have no place in determining health standards for exposure to hazardous pollutants."" ASI 000010775 -2- ) The second was the stress Senator Tunney put on the allegations that MCA and the industry improperly withheld toxicity data on VC from the agencies, and the failure of the press to give further publicity to this controversy. The review article appearing in the attached reprint from the UK New Scientist, is in many respects, a fairer presentation of the facts that has been given by some in this country. Sincerely KDJ/mb Enclosures Kenneth D. Johnson, Ph.D. Secretary Technical Task Group on Vinyl Chloride Research ASI 000010776 SENATE COMMITTEE Oil COMMERCE Subcommittee on the Environment WITNESS LIST* Hearings on Vinyl Chloride Wednesday, August 21. 1974 - `9:30 AM Roon 1318 Dirksen Senate Office Building* Dr. Irving J. Selikoff, Professor of Environmental Medicine, Mount Sinai Medical School, NYC; Dr. Marcus Key, Director, National Institute for Occupational Safety and Health, Department of Health, Education and Welfare; Dr. Joseph Wagoner, Director of Field Studies and Clinical Investigations, National Institute for Occupational Safety and Health, HEW Dr. Umberto Saffiottl, Associate Director for Carcinogenesis, Division of Cancer Cure and Prevention, National Cancer Institute, HEU; Mr. James Agee, Assistant Administrator,`Mater and Hazardous Materials, Environmental Protection Agency; Dr. Theodore R. Torkelson, Senior toxicologist. Health and Environmental Research Department, Dow Chemical Company; Mr. Ralph L. Harding, President, Society of the Plastics Industry Inc., NYC. Mr. Jack Delong, Acting President, Local 3-277, Goodyear Tire and Rubber Company, Niagara Falls, New York; Mr. George Shiah, Member of Local 8-277 and employee at Goodyear Tire and Rubber Company, Niagara Falls, New York. *Not necessarily in order of appearance # // # ASI 000010777 fi ^ j New Sdentict 13 June 1974 1 !. Science paused, and 17 died 675 At least 17 workers have been killed by vinyl chloride because research ver the past 25 years was not followed up. And for over 10 years, workers have been exposed to concentrations of vinyl chloride 10 times greater than the safe limit imposed by one chemical company--Dow Chemical Lawrence l McGinty In January Dr John L. Creech, a works doctor point, and in particular the fate of Maltoni's at a Kentucky chemical plant, made public results, has created a bitter controversy in evidence that has finally forced a full inves the US. Following B. F. Goodrich's disclosure tigation of an industrial health hazard that of the deaths among its ex-workers, the US should have been eliminated many years ago. Occupational Safety and Health Administra Creech's discovery was that four former tion (OHSA) called an informal bearing. At employees of his company (B. F. Goodrich), that inquiry Maltoni gave evidence that he who had been involved in making polyvinyl had discovered angiosarcomas in the livers chloride (PVC) from vinyl chloride monomer of rats exposed to only 250 ppm of VCM. (VCM), had died from a fatal liver cancer Because VCM was found to be carcinogenic at so rare that it kills less than 30 people a year such low concentrations, Maltoni began a new in the US. The immediate implication that series of experiments exposing larger num there is a causal relationship between indus bers of rats to even lower VCM concentra trial exposure to vinyl chloride vapour and tions (250, 150, 100, and 50 ppm). At the development of the liver cancer (angiosar- time of the OSHA hearings, results from this coma) was reinforced less than a month later crucial series of experiments were not avail when an Italian researcher, Cesare Maltoni, able. It was only at a symposium organised revealed that he had found angiosarcomas by the American Cancer Society and the New in the livers of rats exposed to VCM. York Academy of Sciences on 10-ill May that That VCM causes angiosarcomas remains Maltoni was able to say that he had dis to be proved--although the evidence accumu covered angiosarcomas in the 50 ppm group lating is so powerful that the chemical of rats. On 15 April, the US Manufacturing industry and government health inspec Chemists Association (MCA) disclosed that torates have little option other than to act research it had sponsored also showed angio on the hypothesis. But how to act? And why sarcomas at 50 ppm--but this time in mice. has action been delayed, perhaps fatally, for over 30 years? Was there a "cover-up" 7 Hie story could well begin in 1971, with The controversy hinges on a. tentative the publication of a paper by another Italian, allegation in Chemical & Engineering News P. L. Viola. Researching the effects of expos (20 May, p .16) that the MCA, and individual ing rats to an atmosphere containing 30 000 chemical companies, "held in confidence for parts per million (ppm) of VCM (a massive at least a year preliminary, albeit significant, dose), Viola found that "almost all animals scientific findings"--that is, the interim developed tumours of the skin and lungs" results of Maltoni's work. The MCA replied and some developed bone cancers. The that it had been given access by the Euro results came as something of a surprise pean sponsoring companies to the findings because no-one had suspected VCM of being (after "months" of negotiation) only on the a carcinogen, and Viola had not set out to understanding that it would make no look for tumours. Criticism of the. Italian "unilateral disclosure". research, as an indicator of VCM's carcino Maltoni observed his first angiosarcomas genicity, was not slow in coming. The dose in rats in August '1972. ICI readily admits that level was grotesquely high; so high that it was aware of these findings in January the rats' defence mechanisms may simply 1973. In that month the MCA sent a technical have been overwhelmed--leaving them sus delegation to visit Bologna and received ceptible to "spontaneous" tumours. reports of the research there. Thus it is Nevertheless, such is the emotive impact undenied that the chemical industry knew of even a hint of a new carcinogen that four that VCM was carcinogenic in rats at con large European PVC makers (IQ, Montedi centrations as low as 250 ppm at the begin son, Rhone-Progil, and Solvay) decided to ning of last year. sponsor a study by Cesare Moltani, professor ICI and the MCA both say that they passed of Oncology at the Bologna Institute of on this fact to appropriate government agen Oncology. Viola allowed access to his raw cies in July 1973. But the UK Employment oo N data and Maltoni concluded that both the Medical Advisory Service (EMAS) and the skin and lung tumours probably arose in the Factory Inspectorate say that the first inkling N Zymbal gland, a sebaceous gland in the ear they had of the carcinogenicity of VCM (apart O duct which in rats is particularly responsive from Viola's paper) was in January 1974 from i-t o to many carcinogens. Maltoni therefore ICI, which notified them of the Goodrich cases. o o o began an extensive series of experiments on The US National Institute for Occupational rats, mice, and hamsters exposed to ever Safety and Health (NIOSH) denies that it decreasing concentrations of VCM. Simul knew of the angiosarcoma risk until January V) <L taneously, IQ started an epidemiological study of workers at its PVC plant. 1974. In fact, Maltoni's angiosarcoma discoveries The exact sequence of events after this were first made public, not at the February 1 67ii ^ New Scientist 13 June 1974 OSHA faeai.^s, but at the Sec nd Inter national Symposium on Cancer Detection and Prevention held in Bologna on 942 April, 1973. At that meeting, Maltoni read a general paper about occupational oncology, during which he showed a table of preliminary results. There for all to see were angiosar comas in the 250 ppm group of rats (as well as Zymbal gland carcinomas and nephro blastomas). It seems unlikely that the Euro pean companies sponsoring Maltoni's re search would have allowed him to announce preliminary findings at this symposium, while denying the same data to MCA. . The impact of the results contained in the Bologna paper seems to have been minimal. The published version of the paper became available only three weeks ago. One British participant has no recollection of the report of angiosarcomas, despite a personal conver sation with Maltoni at the symposium. It is probably impossible to say whether the chemical industry deliberately and mali ciously hid unfavourable research findings. It is, however, likely that, even if this were not the case, the results would not have caused much of a stir. For by this time, the epidemio logical survey was showing negative results. IQ had found no deaths from angiosarcomas among ex-employees. Thus in January 1973 there was no human evidence of VCM's carcinogenic properties. Because extrapolat ing from animals about carcinogenicity is notoriously problematic, epidemiological evi dence carries greater weight in the minds of industry and UK regulatory bodies. Thus it is unlikely that animal studies alone would have been convincing enough to force a re appraisal of industrial exposure standards. "Firm" evidence only arose after the Good rich report, when other cases of. deaths from angiosarcoma were unearthed. ICI updated its survey and found one ex-employee who died from liver cancer in 1973. Other cases were found in Sweden and the US; the total now stands at 19. Twanty-fiva years' evldenca However, the history of the research on VCM's toxicity is much more disturbing than any allegation of a 12 month cover-up. 'There has been evidence of potentially serious disease among vinyl chloride - polyvinyl chloride workers for 25 years that has been incompletely appreciated and inadequately approached by medical scientists and by regulatory authorities". That is how Irving Selikoff, director of the environmental sciences laboratory at Mount Sinai Medical School in New York, sums up the history. The evidence he quotes goes back a long way. In a 1949 Russian study, 30 per cent (15 out of 48) of a group of FVC workers examined showed evidence of liver disease. The very fact that VCM was once considered as an anaesthetic, but rejected because it was found to be a cardiac irritant should, says Selikoff, have meant a closer examina tion of its industrial usage. Experiments in Britain in the 1960s linked* VCM to aero* osteolysis--an ugly, but seemingly reversible, bone disease characterised by distortion of the skin and bones of the toes and fingers. In 1961 toxicologists from the Dow company published reports of an extensive research programme using rats, rabbits, guinea pigs, and beagle dogs. After three months ex posure to concentrations of VCM between 100 and 500 ppm, animals showed various kinds cf liver damage. Even at the "low" concentration of 100 ppm, livers of subject rats wer e abnormally enlarged. None of these studies even hinted that VCM is carcinogenic. They did, however, indicate a cause for great concern. Selikoff says, "We had evidence here and there that a number of organ systems and tissues were affected by VCM . . . Most of us did not draw the appropriate conclusions---that it should be carefully studied." Anomalies between limits Nevertheless, restrictions on the concen trations of VCM allowed in plants have existed for some time. The first (500 ppm in both the US and UK) were imposed because of VCM's inflammability, not its toxicity. But once limits were created on the basis of medical and animal studies, gross inter national anomalies arose. In the UK, a threshold limit value (TLV) of 200 ppm was set after the discovery of the causal link with acro-osteolysis; incomprehensibly, the 500 ppm limit remained in the US. Even more baffling, the Germans set a maximum work place concentration of 100 ppm in 1970 on the basis of the 1961 Dow research. But Dow itself restricted exposures in its factories to 50 ppm as long ago as 1961--on exactly the same evidence on which the Germans based their 100 ppm limit No other section of the US or European industry followed Dow's lead. The reasons for this international confusion are obscure. Maltoni's evidence at the OSHA hearings threw the whole question into the melting pot. A US temporary limit of 50 ppm was rapidly decided and the UK Factory Inspec torate suggested an interim limit of 50 ppm maximum exposure, and a time weighted average exposure of 25 ppm. But both UK and US limits were devised before it was known that rats exposed to 50 ppm VCM developed angiosarcomas. Now a permanent standard of 1 ppm has been proposed by OSHA--in effect that no worker should be exposed to any detectable VCM vapour. In the UK, it is unlikely that the permanent limit (shortly to be announced) will be less than 25 ppm. Whatever final limit is accepted, there will be a fight between industry and the trade unions-4-particularly in the US. The zero exposure limit is strongly backed by Selikoff. "It is evident," he says, "that no threshold is known that would serve to prevent cancer among exposed workers." Not only does he believe it to be the only safe limit (as do other experts), he also thinks it practicable-- if expensive. "I don't believe a zero limit will involve closing down the vinyl chloride factories," he states, "I have great confidence that engineers will be able to solve the prob lems." The industry, of course, does not agree. ASI O 10779 * ;