Document GK50jkavpBJnXQMJLwRV460x

INTEROFRCE MEMORANDUM To R. Fleming From J. 1. Bartl cc: C. E. Blades R. H. Schenck W. M. Smith L. B. Tepper <r. </,V Date 18 April 1980 Subject _Comments on VC/PV_C_for OSHA Executive (Location, OrganIsation, or Dspartmant) Regulatory Response (Location, Organisation. or Oeoartmanl) Attached are proposed draft comments to OSHA as the result of their inquiry for further information (attached) and the symposium held in Bethesda on March 20-21. Lloyd Tepper Is to perpare the Part I - Status Report on our employees. This Is due May 9. Could I please have your comments by May 5? q (dtow JTB/sjw Attachment / AP00048826 74020 FfHrrnl Kruistrr f Vnt. 44. No. 244 / Tur;(l;iv\ TVrrmbor in. inrp ( Notates Dulcd: Dfcembe/ja, 1979. Frank. H. / ,4ID A<h!*nryCommittee Reprcsmtatire. faint Commttor urfAgricultural Ocvelop/ietit/LZi.irtf far InternationalFood andAjficnlurrnl Development [TH Wfe r*JiMiflld i:-!7.:fce4Sun] cootilliho rris-er-u DEPARTMENT OF LABOR Occupational Safety and Health Administration Occupational Exposure to Vinyl Chloride and Polyvinyl Chloride AGENCY: Occupational Safety and health Administration. Department of Labor, action: Request for information on vinyl chloride and polyvinyl chloride. summary: This notice requests Information on vinyl chloride (CAS No. 75-01-4) and on polyvinyl chloride (CAS No. 0002-88-2). Vinyl chloride (VC), a synthetic chemical, was once synthesized by the addition of hydrogen chloride to acetylene. Currently, the most common route of production is by the halogcnation of ethylene. In this Utter process, ethylene is reacted with hydrogen chloride and oxygen to give ethylene bichloride, which is subsequently cracked thermally to produce vinyl chloride and hydrogen chloride. Vinyl chloride is used primarily to produce polyvinyl chloride (PVC). a plastic resin, through conversion of the VC monomer into a polymer or copolymer form. Vinyl chloride is also used in thB production of methyl chloroform and in the production of resins as a comonomer with vinylidene chloride. PVC is used in the manufacture of a variety of industrial and consumer products, such as containers, wrapping film, electrical Insulation, and pipes. In 1975. OS11A regulated vinyl chloride as a carcinogen, based primarily on evidence of excess liver angiosarcoma incidence following VC exposure (23 CFR 1910.1017). OSHA did not regulate exposure to PVC dust in the same standard. Therefore, it continues to be regulated as an inert or nuisance air contaminant (29 CFR 1910.1000. Table 2-31. Research since 1975 has provided considerably more infurmation concerning the carcinogenic and other toxic effects of VC ami PVC exposure. OSHA is currently in (he process of evaluating the available evidence pertaining to the potential occupational hentlli hazards of VC and of PVC and, by (Ids notice, is requesting information related to severut important issues. OATS: The information requested in this notice must be submitted in quadruplicate on or before February 10. 1000. Aooness: The information requested in this nolirc should he submitted to the Docket Officer. Docket Nu. 1 I*4);i4, Room S0212. U.S. Department of Labor. OSl fA. 200 Constitution Avenue. N'.W.. Washington. D-C. 20210. [202-523-7fiP4|. FOR FURTHER INFORMATION CONTACT: Dr. Peter Infante. Office of Carcinogen Identification and Classification. Directorate of UralIh Standards Programs. Room NUriB. U S. Department or Labor. OSllA. 200 Constitution Avenue. K.W.. Washington. D.C 20210, (202-357-0325). SUPPLEMENTARY INFORMATION! Background Vinyl chloride (C*HiCI: CAS No. 7501-4; chloroethene] is a colorless gas at room temperature and pressure. After synthesis from VC monomer, polyvinyl chloride ((C-H.C1L; CAS No. 9002-88-2: chloroeihene homopoiymer) is in the form of white or colorless granules. Residual vinyl chloride monomer can become trapped in the PVC particles. However, recent processing methods can reduce considerably the amount of residual VC trapped in the polymer resins. The vinyl chloride industry can be divided Into three major components: VC synthesis. VC polymerization, and PVC fabrication. It has been estimated that in the U.S.. 15 plants manufacture vinyl choride. 43 plants polymerize polyvinyl chloride, and at least 7,500 plants are engaged in the fabrication of PVC. During 1978. 3.47 million tons of VC and 2.94 million tons of PVC were produced. The present permissible limit for occupational exposure to vinyl chloride is 1.0 ppm averaged over any fl-hour period, and 5.0 ppm averaged over any period not exceeding 15 minutes (29 CFR 3910.1017). For polyvinyl chloride dust, the standard is 15 mg/m1, averaged over any 8-hour period (29 CFR 1S19.IC00J. Laboratory Studios Experimental bioassavs have demonstrated the induction of cancer by VC at levels of exposure lower than those previously reported. In VC inhalation studies of rats. Multnni (1) has induced liver angiosarcomas at 25 ppm and mammary carcinomas at one ppm. in addition, several different last systems have provided evidence for the mutagenic potential of VC. i.e.. cult. S. typhirmrium. S. pomht, insects, plants, and cultured mammalian cells (2). VC also has beam demonstrated to have a transplacental effect in rots. Inhalation exposure nf pregnant ruts to VC concentrations of G.000 wild 10.000 ppm have resulted in VC-depcndeiU turners in their offspring (!] There is also evidence from animal > studios ili.it PVC may induce non* malign,ir.l respiratory diseasc.lt has been reported that after seven months of exposure, rat* and guinea pigs Caged in work nre.i* where sacks were being filled with PVC powder developed pulmonary pathological changes and granulomatous lesions containing foreign particles thought to be PVC dust (3). Epidemiologic Studies Several investigations of employes population* have indicated that VC/ PVC exposure is associated with an increased carcinogenic risk to several organ sites in addition to the liver. A NIOSH retrospective cohort study of workers from four VC polmerizalion plant showed an excess number of deaths due to cancer of the liver, lung, lympho-hemaiopoietic system, and central nervous system (4). Of further concern is the finding that the carcinogenic risk may extend to industries fabricating polyvinyl chloride. A proportionate mortality study of plastic workers in Great Britain, which included PVC fabricators, demonstrated a statistically significant excess of stomach cancer (5). Also, an excess of mortality from digestive system cancer among PVC fabricators of both sexes was found by Chiazze et. al. in the U.S. (8). Among white females in the study, observed deaths from breast and urinary tract cancers were also greater than expected. Waxweiler et. al. performed a detailed study of the excess lung ca neer risk previously observed a t a synthetic plastics and rubber plant (7). Analysis of lung cancer cases by cell type demonstrated a greater frequency of adenocarcinomas (Type 3) and large cell undifforcnled (Type 4) cancer. Neither cell type is believed lo be strongly assoicafcd with cigarette smoking. Of 12 chemicals analyzed, only PVC dust exposure proved lo be statistically significant, The authors suggested that (he excess of Type 3 and 4 lung cancer cases in this plant was related to PVC dust exposure. A recent epidemiologic study suggests that PVC may be related to pneumoconiosis (8). Employees of a polyvinyl chloride production factory in Italy were submitted to chest X-ray examination. Twenty subjects were difivnnseiJ as having pneumoconiosis. All of those cahus had worked five or more years in departments with demonstrated PVC dust pollution. No AP00048827 Fotlrml 1. .M. Vn. 2-M / Tih-iH.tv. Orri'mlmr ' 15)71) / Notirnu 74029 ,,nioi!s wns nbarrucd in livnr enneers by facility and relevant who worked in hmmj fret) of demoErnphic vnri.iblrs. such ns rc. sex, These findings ure consistent race, date of diiivmisis. dale of death, Ah earlier ctise reports of dale of first exposure, und length of i?ieumoi;ftrii(i5is snuirnt workers exposure fur either vinyl chloride or exposed to PVC du-.l 19.101. The Institute polyvinyl chloride. of Oncolov/and Tumnr Center in (0) Mutagenicity study results of vinyl Bologna. Italy has demonstrated a chloride or polyvinyl chloride as higher frequency ui cvtoicoic.iily measured by the analysis nf human abnormal sputum cells among me body fluids, e.q.. direct mutagenic workers employed in the VC/PVC industry in contrast either to workers in the general chemical industry or to testing with peripheral blood lymphocytes, non-disjunction in humans with YFF sperm test, and m viva individuals who arc heavy smokers (11). Epidemiologic studies also exist which demonstrate the mutagenicity of VC in humans. Chromosomal aberrations in lymphocytes of mate workers, in excess of the number observed in non-exposed workers, have been reported in several studies (2]. Morever. a study of miscarriaces among tha wives o! men occupationally exposed to VC delected a significant excess in fetal mortality following the husband's exposure to VC (12). cytogenetics. (7} Body burden measurements of vinyl chloride in humans. (8) For operations involving polyvinyl chloride, the types of resin in use, the concentration of vinyl chloride trapped in the resin, and the concentration of VC and PVC dust in the atmosphere where individuals are work inn. This information should include estimates of the particles sizes and concentrations of particles that fall within the respirable range. Information requested on vinyl chloride (9) In PVC bagging and milling and polyvinyl chloride operations, atmospheric levels of PVC The date recently received by OSHA suggest that a reassessment of the known health effects of vinyl chloride and polyvinyl chloride is appropriate at this time. Additional information in several areas is needed before a reassessment can be completed. The requested information includes, but is not limited to. the following: (1) Experimental test resuits for carcinogenicity of vinyl chloride at atmospheric exposures of less than SO ppm. (2) Studies of transplacental and VC. monitoring devices used to detect VC. and the type of respirator protection program for individuals working in these operations. This should include the sensitivity and validity of analytic techniques in use. (10) Types of occupations, job classifications, and industries where exposure to either VC or PVC at any level may occur, and the numbers of employees involved in each vinyl chloride \d polyvinyl chloride .-.exposure situation, separated by sex and race. carcinogenic and teratogenic effects in (11) Appropriate engineering controls, humans or animals at any level of work practices, and personal protective exposure to vinyl chloride. equipment available to reduce levels of (3) Experimental studies of exposure to VC or PVC below the carcinogenicity and other toxic current standards, or to the lowest manifestions for any level of polyvinyl levels feasible. chloride exposure. These effects should Include, but arc not limited to. mutagenicity, teratogenicity, SUBMITTALS OF INFORMATION REQUESTED . embryotoxicitv. and other Interested persons are invited to transplacental effects, as well as submit written data, views, und cytotoxic and c\ tocenctic effects on sperm cells. To the greatest extent comments with respect to the issues described ubve. All communications possible, complete information concerning the industrial source of the polyvinyl chloride, the size and should be submitted in quadruplicate, by February 10, lyttu. to tha Docket Officer. Docket 15-044. Room Sti212. U.S. characteristics of thu particles, and exposure levels or curccntrsitions of PVC and residual VC should he Department of Labor. 200 Constitution Avenue. N.W.. Washington. D.C. 20210 (202-523-7tJ!Hj. included for each study. (4) EpidrmioK'uic studies of cither vinyl chloride or of polyvinyl chloride (i.c. cohort, cross-sectional, or cuso- control). (5) Case reports und case aeries of Reference* The following documents, referred to in this notice, arc uvuilnblu for inspection and copying at the CJSt IA Technical Data Center. Room So212. U.S. Lhp.irtim-nt v( Libor. 2<'0 Constitution Avenue. NAY,, Woshington. D.C. brain, lyinplio-hcmutopoictic. lung, end 20210. 1. Mnltonl. C. Vinyt chlnriife e*rcint>ni*ntciiy: An espi'rimentnl model for csrcinoKcnrrnis studies. Or/curs of Unman Concur. Cold Spring HarUor Laboratory, 1977. pp. 11tM4i>. 2. Wagoner. J. K.. and P. F. Infante. Vinyl chloride: A case fur the use of l.iburutory bioossny in the regulatory control procedure. Origins of tfunion Cancer. Cold Spring Harbor Laboratory. 1977, pp. t7'j7-mo5. 3. Fronqio. N.. A. Spinszztiij and A. Bucarclli. I.cjioni polmon.m spr:mcruali da inoiazionc proiumtnUi di pniveri rJi PVC in arobiente di lavoro: iKxparmcntal lung damage from prolonged ir.haialion of airborne PVC dust). La Mcoicina del Lavoro. 65: 321-342.1974. 4. Waxweiier, R. f.. W. Stringer. /. K. Wagoner, j. Jones. H, Falk, and C. Carter. Neoplastic risk among workers exposed to vinyl chloride. Annals of rne.Vew York Academy of Sciences. 211: 40--18.1976. 5. Baxter. P. f. and A. L Fox. Angiosarcoma of tha liver in PVC fabricators. Lancet. 1: 245248.1976. 6. Chlazse. L. W. E. Nichols, and O. Wang. Mortality among employees of PVC fabricators. Journal of Occupational Medicine. Id. 823-623. 1977. 7. Waxweiier. R. J.. A. H. Smith. H. A. Tyroler. and H. Falk. An epidemiologic investigation of an excess iunz cancer risk in % synthetic chemicals plant. Presented at the XIX International Congress on Occupational Health. Dubrovnik Yugoslavia. 25-30 September 3978. 8. MasttOangelg, G.. M. Manno. G. Marier. G. B. Eartoiucci. C. Gcmignani. G. Saiadino. L. Simonate. and B. Saia. Polyvinyl chloride pneumoconiosis: Eptdemioioaicai study of exposed workers. Journal of OccuoationaJ Medicine. 21- 540-542.1979. 9. Szende. B., K. Lapis. A. Names, and A. Pinter. Pneumoconiosis caused by the Inhalation of poVyrinyl chloride dust. Le Meaiana del Lavoro. Si: 433-436.1970. 10. Amaud. A.. P. Pommer de Sami. L. Garbo. H. Payan. and J. Charptn. Polyvinyl chloride pneumoconiosis. Thorax, 33, 19-25. 1978. 11. Maltoni. C. Precursor lesions in exposed populations as indicators of occupational eaneer risk. Annals of the Xew York Academy of Sciences. 2Tj: 444-447.1978. 12. Infante. P. F, J. K. Wagoner, A. J. McMichael. R.). Waxweiier. and H. Falk. Cenalie risks of vinyl chloride. Lancet, i: 734735.1976. Signed at Washington. D.C this 12th day of December 1979. Eulo Binj;bom, Assistant Secretary ofLcbar. l>HUuc.re-ssasa Filed i2~tr.?;.tsan| 81U.1HO coot S1MM Pension and Welfer^'Senefit Programs (Prohibited Trapiaetfon Exemption 79-79; Exemption Application Mq^O-337) Exemption from ^^Prohibitions for Sirr Transp^fions Involving Collego lircrncntifquilies Fund ' AOEHCvrlJcpuftmcnt of Lubor. AP00048828