Document bBXxmLNy02vwJpL5XRRqpe6eo

PO Box No 6 Bessemer Road V.'elwyn Garden City Hertfordshire AL.7 1HD Telephone Welwyn Garden 23400 (STD Code 07073) Telex 264251 Mr J T Seavell Chemists Manufacturing Association 1825 Connecticut Av NW Washington DC 20009 USA Imperial Chemical Industries Limited Plastics Division < Your ref. Our ref js/sew/dso-16 Tel ext 5162 Date 11 January 1980 * Dear Mr Seavell PYC DUST Thank you for the copy of your minutes of the meeting my colleagues and I attended on 28 November. Ke did enjoy our discussion with your YC Eesearch Coordinators group and thank you for your friendly reception and hospitalitj'. Dr Adams had hoped to vrite to you concerning your PVC dust minute but regrettably he had to go off to Germany for a few days and he asked me to vrite and give you his views. Getting to grips with this rather complex IOM study without previous immersion in it poses a number of problems for a secretary. I congratulate you on youx vrite--up. Dr Adams, like myself, wonders whether a page of your notes has gone missing at the end of 4.0. You dealt in some detail with the ''breathlessness" findings to which little importance is attached because the information is derived from a somewhat subjective examination by questionnaire. However you did not deal at all with the most important finding viz the effect of PYC dust on "lung function". While ve in ICI are sceptical about the radiological findings, we accept fully the "lung function" results. Dr Adams did describe the lung function work in the following terms: "FEV1 and FVC were inversely related to the index of PYC dust exposure. Dust effect was studied after standardization for age, height and weight by multiple regression. This demonstrated a small but significant dust effect on FEY and they were also able to demonstrate that the dust effect was most marked in cigarette smokers and not apparent in non-smokers. The magnitude of loss in FEV1 was small. After taking into account the effects of age, height and weight, the overall regression with dust index was - 0.0040 litres per dust index unit.This was equivalent to a loss of 52 ml of FEV1 for the mean dust index. An illustration of this would be equivalent to a loss for all men of 5*2 ml of FEV1 per year during exposure to the mean of the dust index over a period of 10 years. In cigarette smokers considered separately, this loss was 8.9 nil of FEY1 per year. These figures may be compared with the mean losses in the group due to age or smoking. The mean loss due to age is 35 cl and loss due to smoking 20 cigarettes a ilay, 6.2 ml a year- VMD 720501 un 2- fYC - This also showed a significant inverse relationship to dust index among currently exposed men. Gas Transfer -- No significant changes were noted in this test.11 I realise you do revert to "lung function" in summary form at the end of 4.1 but you had not previously dealt with it at length whereas you do give an exhaustive report on the less significant breathlessness results, I hope the above comments will be helpful to you when you come to discuss confirmation of the minutes at your' next meeting. One small point which always amuses us. We are described as "IMPERICAL" . More often IMPERIAL turns out as EMPIRICAL! Perhaps ve are empirical and pragmatic in our approach and it does show through!! The word "imperial" is not popular these days and leads to many a psychological block and Freudian slip. (By the way in 6.0, the company name is VINATEX). We hope you are well and look forward to meeting you again in the not too distant future. With best wishes. Yours sincerely Division Manager Health & Environment Protection VMD 720502 Mil V' 74928 k Q'^xA-C/ Federal Register / Vol. 44, No. 244 / Tuesday. December 18, 1979 / Noticea C Pllft]: D*c*mbr 10.1979. Frank H. Madden. AID AdtUory Committoc Repwntatiy*, Joint CoaunUt** an Agricultural Wrjky3m#s>(. Board(or IntamoUanal Food arxi Agricultural Dortlopmonl. P* D * ru IS-lF-m SM -l m i -** COM 7t*-a-N ' DEPARTMENT OF LABOR ccupeOonel Safety end Health Administration Occupational Exposure to Vlnyt CntortO# and Polyvtnyt Chloride DAT*; The information requested in this notice must be submitted in quadruplicate on or before February 10. 1980. AOOMfts: The information requested in this notice should be submitted to the Dockcl Officer, Docket No. M-034. Room S8212, U.S. Deportment of Labor. OSHA. 200 Constitution Avenue, N.W., Washington. D.C. 20210, (202-523-7894). ton FORTH!* INFORMATION CONTACT; Dr. Puter Infunte. Office of Carcinogen Identification and Classification. Directorate of Health Standards Progrums. Room N3718. U S. Department of Labor, OS11A. 200 Constitution transplacental effect In rats. Inhalation exposure of pregnant rata to VC concenlrations of 6.000 and 10,000 ppm have rcsulled in VC-dependent tumors in their offspring (1). There is also evidence from animal studies thal PVC muy induce nonmulignant respiratory disouse, it has been reported that after seven months of exposure, ruts and guinea pigs caged in work areas where sacks were being filled with PVC powder duvclupcd pulmonary pathological chungcs und granulomatous lesions containing foreign particles thnught to lie PVC dust (3). aocmcy: Occupational Sufcty und huullh Admtmstrailon. Department of l^ibor. ACTSON: Request for information on vinyl chloride and polyvinyl chloride. (OMHAXr. This notice requests information on vinyl chloride (CAS No. 7i--oi -- 1 and on polyvinyl chloride ((.'AS No. 0002-80-2). Vinyl chloride (VC). Avcnuo. N.W., Washington, D.C. 20210. (202-357-0325). UPPLXUBNTARY INFORMATION: Dock ground Vinyl chloride (C,H,C1: CAS No. 75Ut-4: chloroethonu] is u colorless gus ut mom lompcrulure and pressure. After synthesis from VC monomer, polyvinyl Epidemiologic Studies Sovcrul Investigations of employee populations have lndn:uled thut VC/ PVC exposure is ussociutcd with an increased curclnogenic risk to several organ sites In addition to tho liver. A NIOSH retrospective cohort study of workers from four VC polmerlzallon plant showed un excess number of synthetic chemical, win once synthesized by ihc addition of hydrogen chloride <{C,11,Cl).: CAS No. UU02-80-2; chUiroolhone homopolymer) is in the deulha due to cancer of the liver, lung, lympho-hemutopoietic system, and chloride 10 acetylene. Currently. the form of white or colorless granules. central nervous system (4). most common route of production is by ihc haloRenaiion uf ethylene, (n this Residual vinyl chlorido monomer can become trapped In the PVC particles, Of further concern is the finding that tho carcinogenic risk may extend lo- Utter process, ethylene is reuctud wlth._ i iowevor, recent processing methods Induitrles fubricuting polyvinyl chloride. hydrujjen chlondc and oxygen to Rive cun reduce considerably the amount uf A proportlunala mortality study of ethylene dtchUirtde, which is residual VC trupped In the polymer plastic workers in Croat llrituin. which subsequently cracked thermally to resins. inciudod PVC fabricators, demonstrated prxxluLe vinyl chloride und hydroRen Thu vinyl chloride industry can be a statistically significant excess of chlondc. Vinyl chloride is used divided into three major components: stomach cancer (5). Also, un excess of primarily to produce polyvinyl chloride VC synthesis. VC polymerization, and mortality from digestive system cancer (I'VC), a plastic resin. ihrouRh PVC fabrication. It has been estimated among PVC fabricators of both sexes emu er si on of the VC monomer into a that In lha U.S.. 15 plants manufacture was found by Chiuzze ct. ul. in the U.S. poly mrr or copolymer form. Vinyl vinyl choride. 43 plants polymerize (8). Among white females In the study, chloride is also used in the production of polyvinyl chloride, and at least 7,500 observed douths from breast und methyl chloruform und in ihc production plunts uro engaged in the fabrication of urinary tract cancers were also greater of resms us s comonomer with PVC. During 1978. 3.47 million tons of than expected. Wuxweilor ct. ul. > my lidrne chloride. PVC is used in ihu VC und 2.94 million tom of PVC were performed a deluded study of tho excess manufacture of u vuriety of industrial produced. lung cancer risk previously observed at and consumer products, such us The present permissible Umlt for a synthetic plastics und rubber plant (7). containers, wrupping film, electrical occupational exposure to vinyl chloride Analysis of lung cuncer cases by cell insulation, and pipes. is 1.0 ppm averuged over any 8-hour type demonstrated a greater frequency In 1075, OSHA regulated vinyl period, and 5.0 ppm averaged over any of adcnocarcinomos (Type 3) and large chloride as a carcinogen, bused period not exceeding IS minutes (29 CFR cell undlffcrentcd (Type 4) cancer. primarily on evidence of excess liver 1910.1017). For polyvinyl chloride dust, Neither cell type Is believed to be angiosarcoma incidence following VC the standard Is 15 mg/m*, averaged over strongly sssolcated with cigarette exposure (29 CFR 1010.1017). OSHA did any 8-hour period (29 CFR 1919.1000). smoking. Of 12 chemicals analyzed, only not regulate exposure to PVC dust in the same standard. Therefore, it continues Laboratory Studies PVC dust exposure proved to be tatisticlly significant, The authors to be regulated as an inert or nuisance Experimental bioassays have suggested that the excess of Type 3 and sir contaminant (29 CFR 1910.1000. demonstrated the induction of cancer by 4 lung cancer cases In this plant was Table Z-3), VC at levels of exposure lower than related to PVC dust exposure. Research since 1975 has provided thoao previously reported. In VC A recent epidemiologic study suggests considerably more information inhalation studies of rats. Maltoni (1) that PVC may be related to concerning tho carcinogenic and other has induced liver angiosarcomas at 25 pneumoconiosis (8). Employees of a toxic effects of VC and PVC exposure. ppm and mammary carcinomas at one polyvinyl chloride production factory in OSHA is currently In the process of ppm. In addition, several different test Italy were submitted to chest X-ray evaluating the available evidence system* have provided evidence for the examination. Twenty subjects were pertaining to the potential occupational mutagenic potential of VC. i.e.. E. coli, S. diagnosed as having pneumoconiosis. health hazards of VC and of PVC and. by this notice, is requesting information typhimurium, S. po/nbe. insects, plants, and cultured mammalian cells (2). VC All of these cases had worked five or more years In departments with related to several important issues. also has been demonstrated to have a demonstrated PVC dust pollution. No VMD 720503 Federal Register / Vol. 44. No. 244 / Tuesday, December 18. 1979 / Notices < 74929 pneumoconioaia wti obaerved In subjects who worked in areas free of PVC dust. These findings are consistent with earlier case reports of pneumoconiosis among workers exposed to PVC dust (9.10). The Institute of Oncology and Tumor Center in Bologna. Italy has demonstrated a higher frequency of cylolgoically abnormal sputum cells among the workers employed In the VC/PVC industry In contrast either to workers In the general chemical industry or to Individuals who are heavy smokers (11). Epidemiologic studies also exist which demonstrate the mutagenicity of VC In humans. Chromosomal aberrations in lymphocytes of mala workers, in exeats of the number observed in non-expoaed workers, have been reported In several studies (2). Morever. a study of miscarriages among the wives of men occupationally exposed to VC detected a significant excess In fetal mortality following the husband's exposure to VC (12). Information requested on vinyl chloride and polyvinyl chloride The date recently received by OSilA suggest that a reassessment of the knuwn 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 results for carcinogenicity of vinyl chloride at atmospheric exposures of less than 50 ppm. (2) Studies of transplacental carcinogenic and teratogenic effects in humans or animals at any level of exposure to vinyl chloride. (3| Experimental studies of carcinogenicity and other toxic manifestions for any level of polyvinyl chloride exposure. These effects should include, but ore not limited to, mutagenicity, teratogenicity, embryoloxicity, and other transplacental effects, as well as cytotoxic and cytogenetic effects on sperm cells. To the greatest extent possible, complete information concerning the industrial source of the polyvinyl chloride, the size and characteristics of the particles, and exposure levels or concentrations of PVC and residual VC should be included for each study. (4) Epidemiologic studies of either vinyl chloride or of polyvinyl chloride (i.e. cohort, cross-sectional, or cate* control). (5) Case reports and case series of brain. )ympho-hematopoietic, lung, and liver cancers by facility and relevant demographic variables, such as age, sex. race, date of diagnosis, date of death, date of first exposure, and length of exposure for either vinyl chloride or polyvinyt chloride. (6) Mutagenicity study results of vinyl chloride or polyvinyl chloride es measured by ihe analysis of human body fluids, e.q., direct mutagenic tosling with peripheral blood 'lymphocytes, non-disjunction in humans with YFF sperm test, and in vivo cytogenetics. [7) Body burden measurements of vinyl chloride In humans. (0) For operations involving polyvinyl chlorido, the types of resin in use. the concentration of vinyl chloride trapped in the resin, end the concentration of VC and PVC dust in the atmosphere where individuals are working. This information should include estimates of the particles sizes end concentrations of particles that full within the respirable runge. (0) In PVC bagging and milling operations, atmuspheric levels of PVC and VC. monitoring devices used to dotecl 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) Typos of occupations, job classifications, and industries where exposure lo either VC or PVC at any level may occur, and the numbers of employees Involved in each vinyl chloride and polyvinyl chloride exposure situation, separated by sex and race. (11) Appropriate engineering controls, work practices, and personal protective equipment available to reduce levela of exposure lo VC or PVC below the current standards, or to the lowest levels feasible. SUBMITTALS OF INFORMATION REQUESTED Interested persons are Invited lo submit written data, views, and comments with respect to the issues described abve. All communications should be submitted in quadruplicate, by February 10.1980. to the Docket Officer. Docket H-034, Room S&212. U.S. Department of Labor. 200 Constitution Avenue. N.W., Washington. D.C. 20210 (202--523--7894). References The following documents, referred to In this notice, ar* available for inspection and copying at the OSHA Technical Data Canter. Room S02l'2. U.S. Department of Labor. 200 Constitution Avenue. N.W.. Washington, D.C. 20210. 1. Maltonl. C Vinyl chloride carcinogenicity: An experimental model for carcinogenesis studies. Origins of Human Cancer. Cold Spring Harbor Laboratory. 1977, pp. 119-145. 2. Wagoner.). K.. and P. F, Infante. Vinyl chloride: A case for the use of laboratory bloaaaay in the regulatory control procedure. Origins of Human Cancer, Cold Spring Harbor Laboratory. 1977. pp. 1797-1BG5. 3. Frongta. N.. A. Spineuola and A. Bucarelll. Leelonl polmonarl sperimentall da inaiaclone proiungata dl polveri di PVC in ambtente dl lavoro: (Expermental lung damage from prolonged inhalation of airborne PVC dual). Lo Medicina del Lavoro. AS: 321-342. 1974. 4. Waxweilar. R. ].. W. Stringer. |. K. Wagoner. |. jonea. H. Falk, and C. Carter. Neoplastic risk among workers exposed to vinyl chloride. Annals of Ihe Hew York Academy ofSciences. 271: 40-48.1978. 5. Baxter. P. J. and A.). Fox. Angiosarcoma of tha liver in PVC fabricators. Lancet. 1: 245- 240. 1976. S. Chlaxxe. L. W. E. Nichols, and O. Wang. Mortality among employees of PVC fabricators. Journal of Occupational Medicine. 1ST. 823-028.1977. 7. Waxweller, R. ]., A. H. Smith. M, A. Tyrolar. and H. Falk. An epidemiologic Investigation of tn excess lung cancer risk In synthetic chemicals plant. Presented el the XIX International Congress on Occupational 1 leaUh, Dubrovnik Yugoslavia, 25-00 September 1970. 0. Mastroangelo, CH M. Manno, C. Marier. C. D. Bertolucci, C. Cemlgneni, C. Saladlno. L Slmonato, and 0. Sale. Polyvinylchloride pneumoconiosis: Epidemiological study of exposed worken. Journal of Occupational Medicine. II: 340-842.1979. 0- Sxende. B-. K. Lapis, A. Names, and A Pinter. Pneumoconiosis caused by Ihe Inhalation of polyvinyl chloride dual. La Medicina del Lavoro. 01: 433-430.197a 10. Amend. A P. Pommier da Sentl, L Carbe. H. Payan. and J, Chsrpin. Polyvinyl chloride pneumoconiosis. Thorax. 33. 19-23, 1970. It. Maltoni. C Precursor lesions in exposed populelione as Indicators of occupations! cancer risk. Annals of the New Yank Academy of Science*. 271:444 447.1970. 12. lnfaats. P. P, ). K. Wagoner, A.}. McMlchaaL, R.). Waxweller. end H Falk. Cenatic risks of vinyl chloride. Lancet, 1: 734735. 1970. Signed si Washington. D.C. this 12lh day of December 1979. Eule Bingham. Assistant Secretary ofLabor. |rx Dm n saasa nu sumo coec asw-ss-as u>) Pension and Weftor* Boneflt Program* (Prohibited Transaction Exemption 79-79; Exemption AppBcrton No. D-437) Exemption from the Prohibitions for Certain Trert**ctSone Involving Coilog* Retirement Equities Fund AOCMCYi Department of Labor. 720504