Document baNZoJOXzOKgZGrN1zZxqDEV6

-B.F. GOODRICH INVESTIGATING CANCER DEATHS OF 3 EMPLOYES AARON OHIO -DJ- B.F. GOODRICH CO SAID IT is investigating whether the cancer DEATHS OF THRCE EMPLOYES IN THE POLYVINYL CHLORIDE OPERATIONS AT ITS LOUISVILLE AY. PLANT HERE RELATED TO OCCUPATIONAL CAUSES. Vm COMPANY SAID ONE DEATH OCCHD LAST DECEMBER ONE LAST MARCH ME IN SEPTENKB 1971. OOOORICH SAID KENTUCKY AND FEDERAL MEAL7H OFFICIALS HAVE BEEN NOTIFIED OF THE INVESTIGATION. 10 15 AN SDT JAN 2S-74 a j&'P.'WIr.fLa a**-at-/* 7? Three Cancer Deaths May Be Job-Related, B.F. Goodrich Says Former Employes at Louisville Plant All Were Involved in Wyvinyi Chloride Operation Amo*. Ru -- nr C<nc> Ce n t' pva Met mm nvwaa UUMl iaa Mutn tM t AMMAM IWWT M. U4 A MHUt4IU>> IMl>lllty l t HOT AAA4* fi lhTAA Mm m a ma Lmmu. Ii.. ur er MlUM OmOM mM mm Mr Mtm ini< *A M M1M IMflllHI. red n tea liw <mr. Be. tt--i S iMtrwa OMOuh a cne Mr a* mmmmui ka4tt. aaM ua da* mm- ' aUMMM mm ha IU4 wnad; muni Batl trpana iarai uaa him a( aa *mmm M MM PiMAW. 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Aeaaaw. *M Im MtM an* C.ametey Aa Me m w wti nittW H i wmi Ml tea wwiw a* Ma U*rrn t *.! ea* an* eire a a raw* rat annwiM a me Aw iiimM erwa Ulai reatrrk nutnra ia tuner ham. Ter Avar atWtMM el ir C wt.'l naai ma maakraal tr im arwam at Ik.rAre. kw i*e Oaedrarr Mi Im atPrr adT>m fAMaidi ae*-M Arm I ear OMa, Paaricfeamre. * J ; 1 --r * uk. Ca: and Haw. Ul. i RSV 0017085 K4 * RSV 0017086 Medical Dept. , A2SX January 30, 1974 REPORTED CANCER IN POLYVINYL CbLOftIDE OPERATIONS PILE CONFIDENTIAL n. F. Clsqg - 5370 H. J. Corbatt - E3SH J. R. Durland - 5360 G. M. Ellsworth - 1070 Sal Lie - 5300 willies Nassau, n.d. - Phocion Perk - A3SA r. E. Reese - \2.*.A 1S70 A nesting of the MCA Task Pores Coneittee on vinyl Chloride Research held la etchington, o. c. on January 25. Goodrich requested the nesting to discuss the Louleville FVC operation deaths, A copy of their neve releeae wee distributed and little additional information was presented. Sines three canes of cancer had been identified they were required by lew to report thee to the state and ee they were alee reported to IIOU Ooodrieh hne seedeeded in lower leg ta levels in the plnats to sheet 20 ppe. At the nesting, Ooodrieh dietriheted the eatliod they here been eeU* ter steinephsrle eoeiterlag. They are eel eg fine ionisation sad, theepi it in ane-epneiflo, the lasiru--nl ie portable end applicable to neltiple point sailing* A eepy ef their nofhnd is attached. Zt wee npreed that Ki will write e letter to non reaffiminp BA's simpers Use ie the stedj ef thin prohlsa sad rolestearlag flasartlai expert, fie Task Perce eoeitering. The reports ef these osaeittsee ere dee fetranry >0, the tine of the aert Task farce eeetiag. Win att. n. d Mr. H. J. Corbett 2 March 20. I'tlu All our testing and review of records do not indicate any of our employes have a liver problea siailar co Chat reported by B. F. CoodrLch. The foregoing was reviewed with Eoeet Kelly, who agrees with you that we should cake this approach. JJSrow U)^ ,i\rOr A. Over the past several weeks there have been a number of published articles and comments by individuals and companies concerning im possible relationship of VCM^PVC exposure to employee health problems. A number, of meetings have been held invMvinr manuticturers labor unions, the National Institute of Occupational Safety and Health. OS HA. At this stnge the unanswered questions still outnumber those for which we hare firm answers, and it is uncertain when or how this whole matter will be resolved. There is uaivered agreement among all parties that exposure to VCM should be minimised, and most companies are working toward this end. There is considerable disagreement as to what constitutes a safe exposure and I don't believe this cowlroverey will end wtU OSHA comes oat with a permanent standard, and perhaps not then. Rather thaa provide more detail on the opposing points of view, have elected to prepare a chronological description of die most significant events, (from Monsanto's viewpoint) beginning with B* P Goodrich's initial disclosure of their problem. I January 22, 1974 Representatives from B. F. Goodrich meet with NXBH to express their concern thru recent deaths of several employees at their Louis villa, Ky., plant might be related to occupational work conditions. February 15, 1974 Public hearing held by OSHA. OSHA's objective was to determine whether the situation required an emergency ruling or whether a new standard should be developed along regular channels. There was a lot of medical testimony at this meeting and a wide variety of opinions. Everyone seemed agreed RSV 0017090 H. J. ''urbctt, St. !. -I... M<<rcli IZ, 1974 Sun*.m .; y 'jf Rvecr.t PotciHi.il Hraltb !) r.ird Comfr.u:iic H i * n s A. W. Andrews P. S. Park Ci. Rc.jih - Over the past several week* there have been a number of published articles and comments by individuals and companies concerning the possible relationship of VCM/PVG exposure to employee health problems. A number of meetings have L-rcn held involving manufacturers, labor unions, the National Institute of Occupational Safety and Health, and OSHA. At this stage the unanswered questions still outnumber those for which we have firm answers, and it is uncertain when or how this whole matter will be resolved. There ia \miversd agreement among all parties that exposure to VCM should be minimised, and most companies are working toward this end. There la considerable disagreement ae to what constitutes a safe exposure and 1 don't believe this controversy will cad one11 OSHA comes out with a permanent standard, and perhaps not then. Rather than provide more detail on the opposing poled* of view, have elected to prepare a chronological description of the most significant events, (from Monsanto's viewpoint) beginning with D. f, Goodrich's u<*<al disclosure of their problem. I January 22, 1974 Representatives from B. T, Goodrich meet with NJDSH to express their concern that recent deaths of several employees at their Louis villa r Ky., plant might be related to occupational work conditions. febnary 19, 1974 Public hearing held by O0HA. OSHA's objective was to determine whether the situation required an emergency ruling or whether a new standard should be developed along regular channels. There was a lot of medical testimony at this meeting and a wide variety of opinions. Everyone seemed agreed February 20, 1974 March 11 and March U, 19?4 March 11. 1974 March 19, 1974 th.il the OSH A *,\p05,i re >' . 'i rd * "hnuld or reduced from ^00 pari" per mill.on. The United Rubber Workers1 rrprvtrntative Xelt that 100 ppm at acceptable* Some groups wanted SO ppm and sorr.< wanted /.ere. (All numbers represent time v. righted average exposures.) Tabers haw Cooper's Vinyl Chloride Epidemiology Study Interim Progress Report was issued* The conclusions of this report, admittedly preliminary, did not indicate a different mortality experience for vinyl chloride workers than for non-vinyl chloride workers. Twenty-six North American plant* were involved with a study population of 4400 workers* The report alao concluded that for rare condition* suck as cancer of a specific site, the number of cnee* involved in this study was too small to enable definite conclusions to be drawn. Their work will eodheo. HXMH visited the SprlagfleM PYC plait as part of their survey of the P'VC industry* Complimentary remarka were made concerning our record keeping and medical program, but no suggestions or remarks were made concerning work practices* NK36H advised OSHA of official work practice recommendations for VCM/PVC producers* Meeting of PVC producers at MCA office to discuss work practice* and develop programs to communicate to OSHA prior to developeneat of permanent standards. The purpose of this ND6H recommended work practices* Literal interpretation of these recommendations would shut down most of the industry, in the view of those present. w h'- r ". JO? K v~l ' 1. . , \ t ! r OSH V * - : v,urk ,i ri Act. 'V i. .* -r-. :L ' -u'. > r t i . < - - -T' ' - ' ! . f. : % i : H t- . ir1- The - Mfiiej 't PVC pr ! ..c * - v '.I.r.-i . i v . . .. 1.. IL j..s jrr at bi t uiicf nim-.ic, .r.d at w i M impossible v .<. .1 . ** .it * r*tinjj plant dilcs. Un'Orinnately, th.it in ah<n;t the only dung they would agree on .it the March 19 meeting, MCA doct not feel it should play a subatuntir.t role in resolving difference * and it seems unlikely that the major companies involved will be able to -<gree on a common approach in time to influence ObHA's final r ile si tting. Instead they will be- making individual communication* and appeals to OSH*, somewhat on an every man (or himseli basis. NJOSHs position is that they cannot determine that any exposure level to VCM is safe, therefore, they have taken the only way out, i.e. to recommend that there be no detectable exposure. They do allow fur a 'program timetable ' to be established for accomplishing he objectives with the condition that PVC workers wear impervious clothing with oxygen supplied breathing apparatus until the condition of no detectable VCM concentration is achieved. It isn't clear what 'program timetable means, but it could be a point of compromise between the various groups. Our current epo rating practice keep* below an estimated 50 ppm in the Springfield homopolymer PVC plaut, hut we are above 50 ppm (below 100 ppm) in the paste resin plant. Texas City is below 10 ppm. We are currently involved in analyzing what kinds of engineering modifications would be required, technical feasibility, and how much money and time are necessary, to achieve Springfield rxposurc levels of 50, .*5, or 10, anticipating that OS HA will permit a finite exposure level lower thin 50, Major modifications to the rxisting Springfield facility will be very expensive and possibly not justified by the amount of time we ha * r remaining to operate under our agreement with florden. From existing data it would appear lh.it Texas City would be able to meet a standard of 10 pprn or perhaps less without significant extra cost. All PVC producers .ire in trouble if the standard is "no detectable exposure". RSV 0017093 -4 L'p i-. l!. i v ;> . i ! . . i. - .. rV:1 iiilurr^H i oiu'i t' i . :n ini - nc !- . I *- I reci'Jiu'H-'-'' 1 1 > be .. "!v. t-H ! * >t f r , ;<>n* jnd r;.iU' . rk p r ct 1 t- s ' t.. '.!i `-f C.i **f -. IW' ..t Im'.i p.-ip..-!":1 ; r ( . nip r< h > i i- . .-i iviiiua 1 list t -**. tn- mcH'ii'jr.j will S. i:,i | inr,'. -.i -,t tr-'ngiN urgi-g adcf-tm'' of . t rk - ilt- *> .j nd .. ! : * in rnt t VC M p*|<-'firf le\ * 1 - :.ol : s v' t*a ^0 ;<j/. . The s . - c ' n;i *d t: : n a n >tiU of ho lr.t i* * in: , '.,^.1 a > t' 'Hit i . :i a : definitive ir f : m it ion i y i v.. ilable.- l v .:t snt il mo re We anticipate OSH-4 will issue iti* new proposed standard wjtnin the next few week*. Hopefully by that time we will have developed engineering ur.ei cost information which will allow ,< schedule of implement-, t ion to meet the new standards or perhaps an early phase-out .it Springfield if 05HA elects to adopt NIOSH's recom mendation* presented. Also, wc are proceeding with additional medical testing to confirm or deny the possible adverse effect of VCM/PVC exposure on Monsanto employees. To this point, examination of health records, death certificates, and results of physicat culminations on current employees (140* people tested) fail to indicate any work related health problems. This conclusion should not be stated more positively since the various medical groups involved are looking for more precise and definitive test methods. For now, our health records and physical examination results are encouraging. We will keep you advised as new developments occur. /d rd II--r P. WheaIt A3SA I July 22, 197* D, B* Colenbo - St, Louis VCH Anglosarco-- V. J. Heberle - St. Louis R, S. hurray - Detroit --randun - L. P. Paradis to fl. M. Sherwood 7-9-74 T. R. VanAcker - St. Louis TO R. N. Sherwood - St. Louis As we discussed last week, I would rnewer these questions In the referenced -- as follows* (1) Although the early wor.. done with rets In Italy raised the question of possible lnpurltles in the vinyl chloride causing the cancers, subsequent studies were done with "pure* eaterials. We don't know of any responsible people who still q--stloo tbs souse and effect of vinyl chloride and aagloeareo--. (2) The first la--la of w30or,t0c00repmoir*ted la 1970 waa with later studies have been at --re reasonable levels. Host rsc--tly, aloe were sxpossd to 30 PPM in the start! ss spo--end by 0. I, Industries sort rats sipossd to 30 P9K la studios sp--ssrert by ths Baroyeea Division hove tts osdssusus of Industry representatives is that ths oases la hi-- have resulted frua sayaaure years ago to levala greater than asvural hundred fflU farther, all of the lartustry representatives who tea* tlflert st ths resent 0S8A hearings Indi cated that aortas-- did aot suffer problsns with Iswals below 50 pm, (3) The OW proposed per--nt standards will nrpiln exposure less thsa *any detectable level using s --thod sensitive to o-- PPM*. Xnhor and so-- of the seleotlfle witnesses exporting the unions support ths 08BA Ths m witnesses hove proposed a level of 85 PPM as a "TWA* - tl-- weighted average with s pemltted excursion to AO PPM. further, this proposed level would be progressively reduced during the next two years, so thst la A. Item ruaaals 25 Octotoar,1976 loeiity of tha Plastics Industry 1. d TO C. OXER - St. Louis Dear Curt, You wrots to M on Icptiter 16th ssting about chronic tasta being conducted_oa plastic precursors sad aoaeaers* being carried out at BZW1, only study being carried out thara is ia raapact of which la baiay steinI starad to rata, la __________ They dual good a drinklag eyetsn eoyatlbla with tlwlfSlUtjr la uater, than procasdad udth a stady la tfcldi tbe telaa doaaga level ia 2M pp of vinyl ob Ionite la ustor. ibla etudp another ala uaaka ta nterd lea ante partod ia obmIi itloa la no difficulty In steal ab liberty to t thite ra of tba Jto sorter lea. on parsons! rolntlona with tba scalar ataff of USA sra aaoellaat, and It U not iapoaalblo a tlmm to oat tefca bafora it la tonally aOUihad. . . /2 Incidentally. with regard to vinyl chloride. I hear that a nuabcr of angiosarcomas have developed in Maltoni'a current inhalation study in the group of rats exposed at 23 pj*. / A. Nunn P.0. Z vct you are already aware that the Institute of Synthetic Mhbsr Procedures has wi--lossd a carcinogenicity study on butadiene, and that the International Isocyanate Saatltute has a carciaofwlsity study being carried out at tbe ns tel too labe. os a toluene di-lsncyesete. AM/jl# AM 5.D. lagletoo - LLH 12th November 1976 VINYL CHLORIDE # ** A. nunn - Hrur^cls G.J. Lcvinakas - St. Louis R.M. Pittllo - Brussels CXLLUi.!i.lXi.L At recent noetlnt of BXBRA Ptntl IV Dr. Lloyd gave soaa confidential information which should not 90 outside the company oe tha proyrass of tha BIBIIA VCM feedlny trials vita rata* Tha study was at its 97th weak and will contlnua pant tha 104 th weak* Dostbs started at tha 90th weak. Laval of VCM la water 2M pe as " a.s Males Olad heouri 17 2 90 *0 17 t Paneles Diad 37 12 11 If 4 0 0 Zt is ooadSadad that Intestine of VCM prodocas results stellar ts iahalatloa. Z theeyht yea should knew of thoso raselts sad yoa will aadoratand tZMA's dasiro to keep thee coafldaatlal until the stady la wlsts. . .-v Morisant* Mi iecAnw-i 0pL <* Sn# & Environments! He July 29. 1979 mmct VINYL CHLORIDE AND HOWARD YOUNG nrr(>-(( 70 Dr. Sherwio Mlt C2SA * Wa have saarchad our fila for any data ralatad to naurologic affacts and vinyl chlorida. I baliava that wa can aay that thara la no avidaaca that thara la a chronic affact on tha narvoua ayatan, though thara car- tainly ia an aaaathatlc or narcotlc-lika action canon to nany hydrocarbon gaaaa. Our fllaa ineladad a tranaXation of a caach vinyl chlorida affacta and it doaa daacriba naiioaa dia- 3. Tha sacood itm is s raport is s trallai *flw Saw Fntilnair " atilrh dna ito oaaa aaaoelatad with tha fabrication of WC. ly l larga, it is ranotniiad that fabrication affacta baoauna of tha ralativaly to i * ***** ohiorlda^la^tha reals. Vbn> 1hbTMla?>??aoffy0af<y?ip?rtrfrqs*s0iMt^BfIrii1t by finally, wa gat^a^toratwra anarsh^fT** Jr., M. D UMivKJtarrr urn cwscjmmati a. SCns**- . .li . Me Ji ai T i ! " ti r Mon-ante t, . North Ur. tc-r.v Cc . ,<I: .uri - Dear Eaoet: You will rT.ea'*-r that I ?-.. . .1 about a poaslbie oc .-upati^ral ii.^as*' ;.Lr. such for all pra-cticai purpose.*) '.nvolvlr..' r* manufacture of P.V.J. I tain*i _ /cur %_s*. ' Dr. Maurice Johnson, about this at the tl-- c. of the Academy In Coluaous, but have n^\ ;>r*r-J :`r since. r-.i.-j I an now informed by George Hcuor. of cur *.Lr.i Staff, that this disease has b**en 'encountered ir. f manu facture of F.V.C, in one of the countries which he .'isitej last month, and that an article on the subject i- or *c appear in print. This poses a problem to the w-ci- Indus*..-;/ and involves the necessity of being on the lcoicout fer th* occurrence of this syndrome. I would suspe:*. that see: fat-'.. lr.*-r.alv inves tigation is indicated. In ary -a:*-', you ar.i year p ;pl*` should b ow of the prospect, in *:.an.ee, Li s-*- :, f 1* appearance among your Company's vsplyy*~.*. I have retired from the headship of this Daporai-.; r, and Department, as of June 30, and I shall oLru; -o tl 7 South America (Santiago, Chile) on a consult**ion wit J. J. (Jack) Bioaafleld, after a vacation in Montana. I1 till here only to clear up my deK and office, altr.wwh Z ahall return, in same capacity, in D^-ao^r. You \r*> probably awars of the appointment of Eiward p. fcadf-rt. Jr.. M.D. and Ri.D. as ay successor, and I .elicit, for 'in anu RSV 0017103 VOUVOQ ASH 134 abstracts: fourteenth annual meeting ooce daily for 7 days. Since pretreatmrni with 1254 ut this dose caused loss of body weight and striking enlargement and pallor of the liver, lower doses were included. Controls were given H*0 by mouth. On the eighth day, after a 16-hr fast, animals were either sacrificed for determi nation of microsomal cytochrome 6, P-448. P-450, NADPH-P-450 reductase and NADHcytochrome-c reductase, oxidatri9fcv-<lefn'*thvIase. and glucose-6-phosphatase, or exposed to 5 * VCM for 6brand sacrifice 24 hr later ,iver in ury as indicated by centrolobular vacuoliza tion, focal midzonal necrosis an-j increased serum transaminase activity wa* rot apparent in HjO-, SNL-. 3-MC-. or P( .-prttreated rats, while siigh' moderate, and severe injury were consistently found ir HCB-. PC-, and IC'4-preireaicvI animals, respectively. In animals pre treated with 150 //mol 1254 kg. d< * which nearl> tripled P-450. VCM produced the most severe injur> of the combination- toted. Although liver injury was only rur .1 in animals pre treated with an agent which induced P-450, induction of P-450 alone did not correlate with injurv. PC N ahich induced P-450 JiJ .ot potentiate VCM injury. Other cellular components in addition to P-450 may be important in the potentia ion of VCM toxicity. (Supported by N1H Grants ES-00002, OH-00315, AM-16183, and HI -06370.) 29. Results ofa Vinyl Chloride- Teratology Study in Mice, Rats, and Rabbits. B. A. Schwetz, B. K. J. Leonc. F. A. Smith. M. Bxlmer and P. J. Gehring, Toxicology Research Laboratory, Health and Environmental Research. The Dow Chemical Company, Midland, Michigan. The potential of inhaled vinyl chloride monomer (VCM) to have a deleterious effect on the developing embryo and fetus of laboratory animals has been evaluated. In an initial experi ment, CF-t mice, Sprague-Dawley rats, and New Zealand white rabbits were exposed to 500 ppm VCM 7 hr daily during organogenesis. Some of the VCM^xposed mice were also treated with 15 * ethanol (EtOH) in the drinking water as their only source of liquid to determine if concomitant ingestion of ethanol would alter the toxicity and/or teratogenicity of VCM. No signs of toxicity were observed in the adult rats or rabbits during exposure or at the time of necropsy and caesarean section. Among the rats, there was a significant decrease in fetal body weight but the incidence of external, soft tissue and skeletal malformations was not different than among control litters. There was no effect on fetal body measurements or the incidence of external, soft tissue or skeletal malformations in rabbits. Mice were more susceptible to VCM than either of the other two species. There was a slight decrease in the weight gain among mice and maternal deaths were observed (6 deaths/30 exposed mice). The percentage of pregnancy among mice was slightly lower than among controls. There was a slight increase in the incidence of resorptions and fetal body weights were slightly lower than control values but the incidence of external, soft tissue and skeletal malformations was not different than among controls. Concomitant treatment of mice with EtOH in the drinking water accentuated some of the toxic effects associated with exposure to VCM alone. The maternal weight gain and the pregnancy rate was further decreased, but the incidence of maternal deaths was not increased by con comitant EtOH ingestion. The incidence of cleft palate and certain skeletal anomalies was significantly increased among mice receiving EtOH plus VCM. Thus, based on the results of this initial study, exposure of bred mice, rats, and rabbits to 500 ppm VCM during organo genesis did not result in a teratogenic response. Mice were slightly more susceptible to the toxic effect of VCM than either rats or rabbits. Simultaneous exposure of mice to VCM by inhalation and EtOH in the drinking water resulted in toxic effects greater than that observed among mice exposed to either one alone. These results are being used to design additional studies to assess the toxicity of VCM. 30. A Laboratory Aerosol Systemfor Conducting Inhalation Toxicity Studies. B. S. Brar, C. E. Traitor, C. R. Boshart and J. F. Noble, Toxicology Research Section, Lederle Labora tories Division of American Cyanamid Company. Pearl River, New York. An aerosol system has been developed for the safety evaluation of drugs to be used in the respiratory tract. Design features of the equipment include: (1) a spinning disc generator RSV 0017105