Document QXnQogq1nGbQj0wN1J9RdQwY7

3 7ATERENT . f THE MANUFACT* '* ISG JH2uIiTS AS" vIATl^S BEFORE 7HE OCCLPAT ZONAL SAFETY AKD HEALTH AL VI S I ST RAT I *i *4 POSSIBLE HAZARDS OP VIMYL CHLORIDE MANUFACTURE AMD USE FEBRUARY IS, 1974 The Manufccuring Chemists Associatioo (MCA) is a non profit trad* association Having 174 united State* veatber com panies representing mors than 90 percent of the production capacity of bade industrial chemicals within thia country. With respect to vinyl chloride, the subject of this hearing, over 97 percent of the production capacity reported toy Chenical and nyin^arion Pews in May 1*73 ms tn our angers' plants. For the polyner plants, the corresponding figure wea then nearly 88 percent. Vinyl chloride (VC) is a chanteal derived ultimately from petrochenlcel feedstocks and chlorine. Of the 5.2 billion pouade of tks maser produced toy o. s. industry in 197 2, all tout a nail fraction -- lass than one percent -- wne used *n the pro duction of various plastics -- primarily polyvinyl chloride (FVC), Due including u wide .-4c .e uc - IX- '* r rtM. " u -n r Amc ".u *..-.e pl4t;rs. u .; pr.J. lie' t pc- - . e t - _ . * - -e-js c-.dt Of PVC. The importance of PVC prod-c t ;is not -ij -j . - s *- by the value of the unprocessed poly.-ner. Dut acre .roper., oy tr.e almost universal dependence of nearly every branch of industrial and cossercisl activity upon products and components fabricated from this plastic. with this statement, we are submitting a description of the industry and its products that appeared in the December 1973 Issue of Plastics Englamerlog. and wm ask that this reprint be made portion of the record of this hearing. This report makes it clear that the VC/PVC Industry involves a wide variety of chemicele -- initiators, catalysts, plaaticiasrs, stabilisers, antistatic agents, fillers, pigments, and a host of other special ised, but generally very minor, additlvee. under such circumstan ces . the identification of any adverse health affects among the employee# of a vertically-integrated VC/PVC plant with a specific causative agent becomes complex. k few more statistics concerning the industry may be helpful. The 0. f. VC/PVC industry has been operating over forty years, and over the past five years has shown an annually compounded 9 - igrowth rate of 14 percent -- a rate of growth that is expected to taper off only moderately in the next few years, to abc .t 11 percent. U. S. production now reeresents about one-fourth of the wrld total. Syntheaie of the vnoaer is conducted in fourteen U. S. plants, and thirty-seven plants are engaged in polymeri sation. It is estimated that about 1,500 workers are employed ui aonomer synthesis, and an additional 5,000 in polymerisation operations. Zt la difficult to estimate the nu^er of workers employed in converting, molding, and fabricating these polymers, but they axe mafeered in the team of thousands, working la thousands of pleats. It has been estimated the wholesale value of the annual output of fate looted products la over three billion dollars. MCA, as a regular and continuing service to its aateers. has Long had active progriaa in occupational health aad safety. Zta peat aad sarrsat activltiea with respect to vinyl chloride are a natural outgrowth of theme programs. nca`s safety sad fire Pro tect ice Coomittee is now la its twenty-eighth year. Among Its other activities* It has prepared NCA's highly-respected eeriee of Chemical safety Data Sheets for commodity cheaicala throughout this : -3 r -1 : ' *;- r j : : . - . l - .st i i ; - - tc <t i'.J other sp* : j - r - ?r - j . 1 - . i -.d : .i.Ttf-J -^odt, . i l H*a . t *. ' o.tlt i . AJdr ic-aliy, MCA is prepared to 4difU9'.*`t special programs benalf of groups of interested companies. in instances where onif- a limited number are directly involved. Thus, m 1966. when companies were alerted by the Europe an reports of an occupational dlaease among PVC polymerization kettle cleaners, a project was established at the University of Michigan* School of Public Health to detarmine the nature, extent, and etiology of the condition known as occupational acrooeteoly* sis. The results of this study have been published by Ors. Harold J. Magnuson, Bertram D. Dinman and others, in a series of three papers2,3,4 in the Archives of Environmental Health (January L971). Although the role, if any. of vinyl chloride in the causation of this condition could not be defined, the industrial hygiane con trols and improved work practices adopted by the industry have led to a decline to alaost xero in the number of new cases of even very mild forms of this disease. 1t waa in <in effort, to Jtjve.op . d "i i tna 1 ** Je L of t - . s condition tt.dt tt" f*rst observation? _f x-iiCit -a r . ino^e-.e - . - by vinyl rhloride were made. Dr. P. L. . ioia. in a report pub lished in March 19'0<'J reported that rats exposed to 3C.DD0 ppm vinyl chloride vapors for four hours per day, fi.e days per we k for a year.showed degeneration of the skeleton and connective tissue with h istopathological pictures siailar to those observed in human acroosteolysIs of the hands." In his paper, no Mention is mads of the appearance of any malignant tuaori. A few aonths later, however. at the Tenth internet lonei Cancer Congress*, Dr. viola briefly described obaervat lone of --llgnant tuaori in the eer canals of rats subjected to en exposure protocol aLeoet identical with that in hie earlier paper. 9s also reported tueors in the lungs and bones of theee rats, but closed his abstract with the specific disclat--rt "Mo implications to human pathology can be extrapolated froe the experimental soda l reported in this paper." MCA invited Or. Viola to come to the United States as a guest of the Industry, for a discussion with U. S. occupational health experts. On May S and 6. 1971, at a easting with MCA's Occupational Health Co --ittee, he discussed his sort detailed -b report then m press7, and referred to other _-oapleted or underway. Or. *'iola spoke of these jnreported -itjdie* only in rather general turn*. and declined to reveal details. He acknow ledged that hie vinyl chLcride wet of low purity, but expressed his personal opinion that it was the vinyl chloride, per se, and not any iapurities, that was responsible for the pathology he was observing. He claimed to have seen tumors in rate expoeed to $,000 pps, but expected the results would be negative et half that level. Xn his opinion, the $00 pps TLV provided an adequate margin of safety of employees froe the tumor induction he had *een in rat * at tha higher levels. We are not aware of any farther publications by Or. Viola on this subject. The disparity between Dr. viola's findings and the rela tively low toxicity reported by earlier researchers was immediately recognised. For many years, vinyl chloride monomer wee considered u be very low in toxicity, both froe single and repeated exposure. Because of its volatility. Inhalation was considered the only im portant rou*e of exposure for workman. The high flaasmbility of VCM has been considered to be a aore serious haxard than inhala tion. Froe the surliest lists until 1962. tha American Confer ence of Governmental Industrial %gienlsts tACGXH) recommended that the time-weighted average,long-term, 7-6 hour daily exposure RSV 000370? -7 of workMn to vinyl chlonda not xc*ad 500 ppa v/v (12?C ag'n^' Th Li race --ndat Lon basad on single exposure studies on animals and on huMn experience. Pirn -- nil il t im-weighted aver age concentration are published by the ACGIH in an annual liat of "Threshold Limit Valuea' (TLV). A TLV waa considered by this group to `represent condltlona undar which it la baliavad that naarly all workers may ba repeatedly exposed, day aftar day, with out advaraa effect." In 1M3, tha ACOZfl modified thalr rscoaaMdttioa ao that 500 ppm was to bo a mmximm oonceatratloa (or ca il lay) rather thaa a tiaa ws ighted average. it ia thla standard that la la tha 1970 TLV liat promulgated by 0*1 oa my 39, 1971, aa a national con- aanaua standard. Tha chftifs froa a Has weighted to a oaillmg ataadard as, in part, dua to tha pabl loot inn by Tbrhelaoe, Cyan aad Iaa* of tha raaolts of a l* aoath rapaatad Inhalation etudtes oa laboratory aniaala. Thaoa author* raportad slight reversible liver Lajury La rata empaaad ssvss boors par day to 100 ppa, and recommended that tha time-weighted average exposure of workara not emceed 50 ppm. Thla recommendation waa not da --ad sppropriata by Laatar, Qreenberg, ( i and Adame*, howavar, who did not conaidar signifleant injury to j have raaultad in rata which thay had rapaatadly exposed to 500 ppa. 0003708 1 -8 In 1970, ths ACG1H proposed reduction of tSeLr r scoosndsd TLV to * tlas-w* ightsd vsrage of 200 ppa pnaanly on ths Mill of work reported by xruwr end Mutchler^ . The author* reported evidence of clinical findings in workers exposed to t Lnewe ighted average concantrations of 300 ppa vinyl ehlor Ida for many yeera. In 1972, tha ACGIH took vinyl eh lor ids fro* the Hat of Intandsd Chang** and rsvlssd ths vales in thair roguiar Hat to 200 ppa (510 ag/n3>. This value raaalaa ths rsiM--anrtart value la ths 1973 Hat. A copy of ths docuasnt at ion for ths t/ww TLV for vinyl chlorids is provided as sa sttachasot to this In vlv of thsss dsvslopasots, it wi MCA convsns a conference of vinyl chloride aaaafactorors to 41acusa ths prospoct aad feasibility of establishing aa supported research prograa. This nesting* etteeded by tivss of U. I., caaadl-- aad aropsan firms. took place it, 1971. Oo the ialtiatlvo of ooapaaiss attending, a rssssrch project was foraod with MCA participating in an adainUtrtt 1vs role. A contrast with ths Industrial 1I0-TBST Laboratories, lac. of Morthbrook, Illinois, was signed on February 1, 1973, hn cxm^ plsta experimental protocol is subaltted aa an attachaoat to this stataasnt. Ths specifl goals in alnd worst 9 1. to attempt to dupii-ate the European cciervat icr.* with vinyl chloride of a source and quality characteristic cf the U. S. industrial product; 2. to extend these studios to two other species of laboratory rodents -- eice and hamsters, to determine whether the response* of rats eight be species-specific: J. to develop dose-response relationship# with higher limits of statistical confidence, to permit eetimation of potea* tial risks at occupational levels of exposure with greater pre cision} and 4. to determine what the no-reepomee level Is. In these studiee on rats, mice and haswters, groups of 100 aele and 100 female of each species (600 animals at each ex posure level) are being exposed to either 0 (control), 2,500 ppm, 200 ppm, or 50 ppm of vinyl chloride sonowsr, sewn hourk par day. five days per meek, for twelve months. They will then be observed for an additional twelve eonthe (six months for eice). These animals will not have food and voter during exposure. This "lifetime" study is designed primarily as a cancer study and will include only a limited amount of other observations. Because Viola's studies involved simultaneous exposure of food, watsr, and bedding, a separata group of 100 rats of one on sex is being ex- RSV 0003710 t posed to I <.- ; -*_. t'" : I.*;:. d-.: l T"is has been t.";uded te. j ,sv c; c pc s * .l, - - - * . i *. a : - a -1 . _ r f e vinyl chloride notne r with * 11 * r - e f xd. -ate:. i : 11 - j -4, result ir a toxic reaction product. Alt .ho ug h a n l m 1 *poi star tec . n . i~ 3 . eq^. pme n t problems gave rij* to a number of uncertainties that sight have compromised the validity of the results, nence the .nitial 'roup of animals was discarded and a new set procured. The new exposures got underway on September 10. 1973. Up to this time, no significant results have been observ ed in this study, nor would the appearance of any tumors be expected in so short a t Ism . We will keep both OSSA and MXOSH informed as this study progresses. Recognising that there eust always exist a substantial degree of uncertainty in axtrapolating tha results of animal studiaa to the evaluation of workplace hazards. MCA has contracted with Tabershaw-Oooper Associates. (TCA) of terkeley, California, to con duct a study of the causes of death in vinyl chloride and polyvinyl chloride production workers. The objectives aret 1. to compare.the mortality of individuals who have worked in vinyl chloride plants with that of the general popu lation. corrected for area. age. snd sex: RSV 0003711 t - 11 - .2 to conpars Mortality pattern* within the popu lation of vinyl chloride workers, based upon estimated occupational exposure; and 3. to conpara Mortality aaong vinyl chloride workers with the Mortality of othar occupational groups which TCA has studlad. This study is now in its sighth aonth. and a final *eport ia axpactMd to be Issued in April. A copy of tha protocol is submitted with this statsmant. Although tha aortalIty statistics are as yet incomplete, and haws not been analysed, a preliminary review -f the ctvrent data from all plants, other than tha ooe coocerning which the a. T. Ooodrlcb chesiioal Compeer has mm da a public disclosure, fails to show any obvious departure from the pattern and Incidence of the death# that weald be expect ad among a population of the kind that has bean tha subject of this survey. Me will, of aourse, provide OdlA end MXOtM with the final report and alert them promptly should any significant evidemce of occupationally-related deaths appear earlier. NCA'a first direct contact with BXOSH specifically on vinyl chloride led to a conference between an industry delegation. KSV 0003712 L. - 13 frequently far above current standards have not deKnstrated any crrcinogsnLeity to huiaan*.' MCA will expedite the reissue of this data sheet, revised as necessary to reflect new knowldege concerning possible hazards of vinyl chloride exposures. A copy of a February 6. 1974, news release on the withdrawal is attached. As discussed herein. Manufacturers are aware of the poten tial hazard of vinyl chloride and. we are tnforaed. are voluntarily taking steps to reduce employee exposure. Substantial research in now in progress, the rssulta of idiich they believe will provide a fire basis for any standard applicable to VC/PVC nenufacture. Therefore, it is their rsm--snilatinn that OMt proceed under the I provisions of Section 6(b) of the Act. On behalf of its producer eaters. MCA pledgee full cooperation with both VXOdl and OOHA as they atteapt to define the hasards now tentatively identified with vinyl chloride, and develop standards that will assure the safety of workers in this industry. RSV 0003714 t 4_ * LIST OK HCFf f-ENCES PVC Primer. Pl.is.ics hr. i i r.eer i nu _-h-4. I'f 2. Dinman, B. L. Cook, W. A. Wh i Leinou^e, W. X. Haqnuson, II. J.r Ditcheck, Theodore; occupational Ac r -.os teo Ly * i s I. An Epidemiological Study. Arch. Envir'-.r.. Health. 22. 61-73 (Jan. 19711. 3. Cook, w. A Giever, P. M.; Dirusan, B. 0.' Magnuson. H. J.; Occupational Acroo^ttoiyis - II. An Industrial Hygiene Study. Arch. Environ. Health. 22. 74-02 (Jan. 1971) 4. Dodson. V. N.; Dinean, B. D.; Whitehouse, W. M.; Near, Ahnen N. M.; Magnuson, H. J.: Occupational Acroosteolysis - ill. A clinical study. Arch. Environ. Health. 22. 83-91 (Jan. 1971). 5. Viola, P. L.r Pathology of Vinyl Chloride. Medicine del Lavoro. 61, 174-179 (March 1970). 6. viola, P. L.: Cancerogenic Effect of Vinyl Chloride. Presented at the Tenth International Cancer Congress. Houston, Texas (May 22-29, 1970), 7. Viola, P. L.r Bigotti, A.; Caputo, A.: Oncogenic Response of Rat Skin. Lungs, and Bones to Vinyl Chloride. Cancer Research. 31, 516-522 (Mey 1971). 6. Torkelson, T. R.; Oyen, F.r Rowe, V. K.: Am. Ind. Hyg. Assn. J. 22, 354 (1961). 9. Lester, D.: Greenberg, L. A.; . Hyg. Asan. J. 44, 265 (1963). R.j am. ind. 10. Mutchler, J. I.; Krawer, c. G: Report on Relation of Expoeore to State of Health of Dow CheMieal Workers, Gordon Conf., Tilton, M. h. (August 1968). RSV 0003715