Document DGb6mgydrqM4yON3yQ14QzqQ4

t ij\v'M i * ' ~ r*~ allied chemical corporation P-0. Bo* 224SR, Mormiown. New jersey 07960 (201) 538-6000 December 3, 1971 RECEIVED DEC06J97J Mr. R. N. Wheeler Union Carbide Corporation 437 McCorkle Avenue, S.W. South Charleston, West Virginia v LR-J. wheeler Dear Nick, Pursuant to the MCA meeting of November 16 on vinyl chloride, the following are writer's questions and suggestions concerning the proposed manufacturer-sponsored toxicological research'. (1) After I left the meeting, it suddenly occurred'to me to question the diagnosis of the lesions as cancers vs. tumors. I presume the evaluation is conclusive but, if it is not, some part of the proposed protocol should include a recovery period to note whether the lesions regress. (2) It is presumed that no human tumor has yet been attri buted to VCM, but it would appear to be worthwhile to review the working population that was used by the University of Michigan for study of acroosteolysis. This certainly includes the most highly exposed popu lation and, if no tumors exist here, it can be argued that human experience, if of reasonable magnitude, should take precedence over animal studies. It is conceded that this lesion was not sought in Dr. Dinman's study but, from the available records, it might be easier to review this population than another completely new one. I am thinking of a limited edipemialogical study* possibly at a substantially lower cost. (3) In the matter of analysis of EDC or acetylene derived samples of VCM, we do not expect to discover known carcinogens. However, it does seem desirable to know whether there are any gross differences in the samples used by Dr. Viola and those to be used here. Certainly the 25 (or 29) impurities mentioned are not all present in equal quantities even if made by the same process, and I suspect that process difference may be substantial. At least we should know the variation which can be ex pected and be certain that the material used' is within limits set by analysis of at least six samples from each process. To be certain that sample impurities do not reveal proprietary process secrets of any manufacturer, MCA could act as a clearing house for analyses. A look at the analyses does not necessarily mean that the 0 CA C"1 0 vv O O BFG49934 ucc 000500 I Page 2 Mr. R. N. Wheeler December 3, 1971 toxicology project need be delayed. Each manu facturer should be able to report analyses of a few batches within one month and, if no major deviations appear which are of major^confcern, study could start immediately. Will one sample (single unit tank car) of VCM be used, or will it be used from "one-ton" or smaller cylinders? (4) We have no serious objection to the exposure protocol but would prefer one non-rodent species even if numbers of animals (possibly dogs or monkeys) were substantially lower in number. We realize that statistical result will not be as significant, but the opportunity to observe a completely different species where metabolic pathways may be substantially different would,appear to justify the statistical sacrifice. (5) Mutagenicity and teratogenicity were mentioned briefly at the meeting, but we can recall no decision as to whether such studies would be included. We think tests in this area might be desirable but have no strong feeling that they should be included in this protocol. Dr. Legator of PDA believes that mutagenicity may be predictive of carcinogenicity. In view of the lack of any similar visible lesion in a substan tial exposed human population, we doubt that regulatory agencies in this country will take any precipitous action before confirming the results.here. We do believe that samples of food-wrapping films should be tested for migration into solvents simulating food to dis cover levels which may be expected from reasonably standard PVC formulations. We will be happy to cooperate with the industry group in this matter of safety and health of employees and public. Sincerely yours, Toxicology-Consultant WAK:pb cc: Dr. Norman G. White Shell Chemical Company Dr. Benjamin M. G: Zwicker B. F. Goodrich Chemical Company 000501 its Lou IS Vi a. *<=., 4V . r-Dr. Maurice N. Johnson, the Company's director of environmental health, said he had recently received medical reports concerning the death of an employe late In December. A review of medical records uncovered that two other employes had apparently died from the same cause -- one In September, 1971 and one In March, 1973. The reported causes of death-are subject to verification, he added. f "Awareness of this grouping," said Dr. Johnson, "warranted a thorough investigation and prompt notification of the two government agencies most directly concerned." The B.F.Goodrich Company has been conducting programs to reduce exposures to hydrocarbons, particularly vinyl chloride, throughout its operations. While all plants were operating at levels well below those prescribed by Federal government standards, a successful effort has been made to reduce levels in these plants to approximately one-tenth those specified. (more) to tn o o o o - BFG49936 \ A*ZM UTHQ, '.S.A. -2- These efforts have included development of the most sophisticated monitoring systems now known; strict rules on procedures where exposure might be increased; a complete checking of all pipes, valves and similar equipment to prevent leaks, and extensive improvements in ventilation .s systems. "The death in December, considered-in relation to the two previous similar cases, has'caused us to initiate intensive Investigations throughout the vinyl products operations of the Company," Dr. Johnson said. "To be sure we get the best ^independent evaluation and guidance, the Company has engaged Tabershav-Cooper Associates, Inc. of Berkeley, Calif. Dr. Irving R. Tabershaw, one of the country's foremost experts in the field of public and occupational health and safety, is supervising the work of this consultant firm," Dr. Johnson said. The Company has instituted a program of explaining the new Informatio and steps the Company, is taking to all employes Involved in vinyl products r production. Xn addition, the Company has put into action a program to reduce exposures to vinyl chloride and other hydrocarbons to the minimum possible in all vinyl operations. Operations of the plants are continuing under the program of minimum exposure levels. "We are providing medical examinations to all employes involved In any phase of vinyl chloride or polyvinyl chloride production and reviewing available medical records of any deceased former or retired employes," Dr. Johnson said. "Ue have assured officials of NIOSH and Che state of Kentucky that we will continue to provide them with any significant new information as it develops," he said. -o- 1-2374 ucc 000740 0 Ui C' o o o c; medlCOl reportsconcerning me acaui cl an em-i pldy]th late Dcember. "A review of medical] records' uncovered that two other employee, had apparently {bed from the-aame 'cause--one In' September*; ltL and one In March company;' N . V thd ' 'wai'. qndeiatood that a .fourth death--lit IM^Invomng^a'more copmon.focm of liver ^anccrfwai ^nlr(&e&d:out8tde .the reasonable' bobodJ oJJthe'- V^roapln^', of the three recent d&iths^airattributed to.angiosarcoma. -\ ' ^<SoodriEfo|nl<li(;,ha4. lafoniied Kentucky heaim ottfdalir:phd `tfci. Federal National Instt.' tuba OccuphilOTai sif<ty, and Health tbat'th*; '^mi^^w^jiiiyesugiUlng^the possibility that? the diilprd^^;^ \^lat<|d to occupational 'Si . -.-jECeojUfflffi^rffidfrli V ftald theyhad Just learned of'the situation at tfie Louisville plant. iind'liadnHc^d.a'modieid.-^Mrt to Investigate.'' &''Ro<^vnie7^Md-v* epokeanjen for HIOSH said] i ala^-ofajcperfs vml airrtye lit Louisville this]! jnorningitobegih an investigation. * .'- "i 1 ' IDr.-Jfarct^s *' Hey,' director of KIOSK,'said. : thpThsUUiW'alisp'wIll atep up efforts to deter-, mine',,the extent! of ;knytoSartsoma- lii the U.S.,- and In.foreign fcountrieswith similar manufae-> tuting processes' 'A.spokesman for the Institute' so id.' the best\lnfonttatioa available shows 21 deaths per yeac^lii (he U.S. ^attributable to an-' giossKfflnia;=;' ' `i '-.' The recent deaths]at*UMiisvltlc,' according]; ttf br.'jjotaison 'pf ijoodrichi Involved worker^- In the CbnipanySa vinyl products operations. An, official--otJ&OSH.said heyunderstood that'the; i workers had -an'average ol;0 years' exposure' `to Varlouai; cliemicals;.ahd. agents Involved In; i vinyl-operations^' ; ' ' I Goodrich said It has bd conducting a pro-; gram to reduco-'expbsure to hydrocarbons, par-^ tlculajiy vthyl-'cltforjde, throughout Its opera tions^ "Further..`steps to limit'exposure and to' describe tha.aUuatlon;to workers In vinyl prod-, ucts production"are. being taken,-the company, said. -.'1 . Goodrl'ch^alsd said]It ls-providing medical' examinations,to.all employes Involved In any phase ot* Vinyl ichlodde'or-polyvinyl chloride production, and Is reviewing all Us medical records of former or-YcUred employes. : About1.2C0 persons work at tho Louisville uinnt. of whom about 270 are Involved Ln vinyl' prednets operations..- "J7rj,f.iiic of n .......... & * V\ I"* CJ h- o BFG49938 ucc nnn7do  "X U. S. OEPARTt.lL,IT OF LABOR OFFICE OF INFORMATION. WASHINGTON. 0. C. 2021Q CONTACT OFFICE AFTER HOURS Malcolo Barr (202) 961-3914 (703) 3S4-0199 USOL-- 74-37 FOR RELEASE: IMMEDIATE Thursday, January 24, 1974 OSHA INVESTIGATING GOODRICH CANCER FATALITIES The U.S. Department of Labor announced today it will hold* a public hearing early next month to determine the scope of occupa tional health problems affecting workers involved in vinyl chloride operations. The Department also announced it has sent two industrial hygien ists from the Occupational Safety and Health Administration (OSHA) to investigate polyvinyl chloride production operations of the B.F. Goodrich plant in Louisville, Ky. Goodrich announced Wednesday it is investigating whether the cancer deaths of three employees are related to occupational expo sure to its polyvinyl chloride production operations. One employee died in September 1971, one in March, 1973, and the most recent one last month. The OSHA experts will investigate jointly with officials from the state and from the National Institute for Occupational Safety and Health (NIOSH) of the Department of Health, Education, and Wel fare. OSHA's investigation is aimed at determining whether violations exist of federal job safety and health standards on worker exposure to vinyl chloride.' The hearing to be held next month will determine the extent of possible exposure and whether there is a need to amend the OSHA standard. Under federal limits, workers may not at any time be exposed to vinyl chLoride in concentrations greater than 500 parts per mil- to C/s iCJ Cv RSV 0000620 BFG49939 B. F. GOODRICH COMPANY POSSIBLE JOB-RELATED CANCER DEATHS The announcement by B. F. Goodrich Company of three possible job-related cancer deaths at their Louisville, Kentucky Vinyl Chloride Resin Plant is potentially a very serious problem^for the PVC resin industry. Our own medical records, along with a preliminary report by Tabershaw-Cooper Associates on the industry-wide epidemiological study indicates that the problem has only occurred at the one plant. The Tabershaw-Cooper study will be completed about the end of first quarter, 1974. This study, covering 6,000 industry employees, will show whether there is a significant occurrence of cancer or other disease in the industry versus a selected control popula tion. As a result of the announcement, Union Carbide reaffirms its plans in the following areas: 1. We will cooperate with and sponsor through MCA t}*e Xabershaw-Cooper Associates epidemiology study as well as other MCA-Indus try sponsored studies on vinyl chloride. ' . 2. Our employee medical surveillance ifl'much more thorough that of B. F. Goodrich and we will certainly cooperate if the industry proposes additional testing. 3. We have pursued a policy of minimizing employee exposure to vinyl chloride and will continue to reduce exposure levels. 4. We will cooperate fully with the NIOSH and other governmental agencies in their efforts to study the problem. 0 cn iCO o . RNWJr/ra January 28, 1974 BFG49940 ucc 000743