Document 4JqKY1VBjJJE3grvzr94aX6bQ

PR POSED RUIZS 18303 Copied by MCA DEPARTMENT OF LABOR Occupational Safety and Health Administration [29 CFR Part 1910] [Docket OSH-36] ,, VINYL CHLORIDE; OCCUPATIONAL EXPOSURE STANDARD ' Hearing On May 10, 1974, notice of proposed rulemaking with regard to a permanent standard for occupational exposure to ty and Health Act of 1970 (84 Stat. 1593. vinyl chloride was published In the Fed 1596. 1599; 39 U.S.C. 655, 657), Secretary eral Racism (39 PR 16996). The notice of Labor s Order No. 12-71 (36 FR 8754) provides an opportunity for public par and 29 CFR Part 1911, the notice of the ticipation in the proceeding, by means proposed rulemaking on vinyl chloride of written submissions to be mailed to the given address, postmarked no later than June 10,1974. The notice also per mits Interested persons to file objections to the proposed standard set out in the notice and request a hearing thereon. The objections must specify the pro visions of the proposed standard to which objections are made, state the grounds for the objections, be accom published on May 10, 1974 at 39 FR 16896, is hereby amended in the lollow- lng respects: (1) The part of the notice concerning the filing of objections and requests for hearing. In the third full paragraph of the middle column of page 16897 of the May 10 Issue of the Federal Register, Is withdrawn; and (2) In lieu thereof the following paragraphs are added: panied by a summary of the evidence to be adduced at the requested hearing, and must be postmarked no later than June 10, 1974. Informal contacts with Occupational Safety and Health Administration staff have disclosed widespread Interest in the proceeding, a probability of requests for a hearing, and an alleged need for more time for the submission of written com ments and the formulation of objections In accordance with the requirements of the notice. Accordingly, It has been decided to waive the requirements for objections and request for a hearing thereon and Instead to set for hearing the entire pro Data, views, and arguments concerning the proposed standard will be received by an ad ministrative law Judge, to be appointed bv the Chief Administrative Law Judge of the Department of Labor at an informal hear ing to begin at 6:30 a.m. June 25. 1974 In the Departmental Auditorium on Constitution Avenue, between 12th St 14th Streets, KW,, Washington. D.C. The hearing shall be conducted In accord ance with the rules of procedure In 29 CFR Fart 1911. Any Interested person desiring to , participate at the hearing must file a notice of intention to appear with Ms. Joanne Good ell, Attn: Docket OSH-35, Occupational Safety and Health Administration, 1726 M Street, NW,, Boom 200. OH. Department of Labor, Washington, D.C. 20210 no later than June 17, 1974. A notice must state the name posed standard, set forth In the May 10 notice. It is hoped that this decision will: (1) Eliminate the possible difficulty of formulating appropriate objections with in the short period of time fixed In the notice; (2> permit full participation at the hearing, without limitation as to Is sues; and (3) expedite the proceeding, and address of the person to eppear, the ee- paclty In which he will appear, and the ap proximate amount of time required for his presentation. In addition, to the extent prac ticable, the notice should contain a general statement of the position to be taken with respect to any provision of the proposed standard, and of the evidence to be adduced In support of the position. in view of the six-month provision in sec tion 6(c) of the Williams-Stelger Occu pational Safety and Health Act of 1970, and the expectation that a hearing would In all other respects, the May 10,1974 notice of proposed rulemaking remaim unchanged. Signed this 22d day of May 1974. be requested and scheduled anyway. John H. Stender, Therefore, pursuant to sections 6(b), Assistant Secretary of Labor. 6(c), and 8(c) of the Occupational Safe [FR Doc. 74-12188 Filed 5-23-74:11:15 am] Xo. 109--Ft. I- RflltAl Kfoism, VOL M, NO. 102--rtlOAT, MAT 24, 1074 UCC 083563 V Copied by MCA. CONSUMER PRODUCT SAFETY COMMISSION [ IS CFR Fait 1500 ] ____ SELF-PRESSURIZED HOUSEHOLD SUB STANCES CONTAINING VINYL CHLORIDE Proposed Classification as a Banned Hazardous Substance In response to recent Information on the toxicity of vinyl chloride monomer and in response to a petition received on February 21, 1974, from the Health Re search Group, Washington. D.C., the Consumer Product Safety Commission proposes to ban as a hazardous sub stance any self-pressurized product (aerosol product) for household use con taining vinyl chloride monomer. By notice published May 9. 1974 (39 FR 16511), the commission determined that consumer products containing vinyl chloride monomer as a propellant or ingredient are products which could create a substantial product hazard and required manufacturers of such, products to submit certain information to CPSC. Section 2(f)(1)(A) of the Federal Hazardous Substances Act (15 UJS.C. 1261(f) (1) (A)) defines "hazardous sub stance" as "any substance or mixture of substances which is toxic * * * if such substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proxi mate result of any customary or rea sonably foreseeable handling or use, in cluding reasonably foreseeable Ingestion by children." Section 2(g) of the act states that "the term toxic shall apply to any substance * * * which has the capacity to produce personal injury or nine-- to man through ingestion, inhala tion. or absorption through any body surface." Section 2(q) (1) (B) of the act defines a "banned hazardous substance" as "any hazardous substance intended, or packaged in a form suitable, for use in the household, which the Secretary (now the Commission] by regulation classifies as a 'banned hazardous sub 1811' stance' on the basis of a finding that, notwithstanding such cautionary label ing as is or may be required under thii Act for the substance, the degree 0` nature of hazard involved in the pres ence or use of such substance in house holds is such that the objective of the protection of the public health and safe ty can be adequately served only by keeping such substance, when so in tended or packaged, out of the channeLi of interstate commerce." The Commission has determined that reasonable grounds exist to propose the banning of self-pressurized products for household use containing vinyl chloride on the basis of toxicity. These grounds Include the following: (1) Human data. On January 22.1974. the Occupational Safety and Health Ad ministration was informed by the Na tional institute for Occupational Safety 'and Health (NISH) that the B. F. Good rich Chemical Company reported that deaths of several of its employees from a rare form of liver cancer may have been occupationally related. The employees of the B. F. Goodrich Chemical Company who died from angio sarcoma of the liver had an average exposure of approximately 19 years of vinyl chloride, at unknown concentra tions, and variable exposures to other volatile chemicals. Some employees of Union Carbide Company and Goodyear Company are also reported to have bad exposure to vinyl chloride and to have died from angiosarcoma of the liver. Finally, autopsies of four deceased em ployees revealed that liver angiosarcoma tumors were histologically indistinguish able from the angiosarcoma tumors observed in Professor Maltoni's experi mental animals (see below). (2) Animal data. Professor Cesare Maltoni, of the Institute dl Oncologia, Bologna, Italy, reported on a series of experiments on the effect of exposure of rats, mice, and hamsters to vinyl chlo ride at concentrations of 10,000; 6,000; 2,500; 500; 250; and 50 ppm for varying period of time. Some of the experiments have been concluded, and others are still ongoing. The experimental results so far reported are that tumors have been ob served in groups of animals exposed to vinyl chloride at concentrations as low as 250 ppm. These data are contained in the trans cript of an "Informal Fact Finding Hear ing on Possible Hazards of Vinyl Chloride Manufacture and Use," US. Departmen'. of Labor, Occupational Safety and Health Administration. February If. 1974. A copy of this document is avail able for public Inspection at the Office of the Secretary, 1750 K street NW,, Wash ington, D.C. 20207. The Commission is In receipt of a peti - tion from the Health Research Group, set forth below, "to Immediately prohlbi, the continued use of vinyl chloride as :i propellant for aerosolized consume .* products and to remove all products con taining vinyl chloride as a propellan: from the market because there is sub stantial evidence that vinyl chloride 1* KPMAl ttoism, VOL 19, N . 101--THU2SDAY, MAY 23, 1*74 UCC 083564 V PROPOSED RISLES 18117 ine polvvinyl chloride plant. the Department Dr. Maltoni reported that he la currently Dated: Washington, DC. February 2'. of Libor published on January 30. 1974, a conducting an experiment using 800 rate 1974. request for Information and a notice of a exposed to 50 ppm, slnoe the failure of the fact-finding hearing on the possible hazard* low does of vinyl chloride to Induoe cancer aaaoctated with the maufacture and/or uae may be a function of the small number of Respectfully submitted, Anosca M. Hxicko of vinyl chloride (Roc*al Rraurxa Janu animals tested. SmwxT M. Wolfe, MD.. ary 30. 1974). At the hearing held on Febru- In addition. Maltoni has observed two fi tOOO P. Street. H.W. #7ot ,ry is, 1974. the Industrial Union Depart brosing ' angiosarcomas in ths offspring of Washington, D.C. 20036. ment of the AFL-CIO petitioned for an emer pregnant rata exposed to vinyl chlorlds. He gency temporary standard to prevent any stated that such fibrosing angiosarcomas Rtruzncss worker exposure to vinyl chloride. have never been observed es occurring spon American Conference of Government Indus VI. fhe Grape Danger Remitting from Ex- taneously In Sprague-Dawley rats. trial Hygienist* (ACOIB), Documentation porure to Vinyl Chloride--A. Acute Effect!. C. Other Evidence of Liver Disease. Aa of Threshold Limit Values, 1971, pp, 477- v'lnyl chloride la a fee which can cause un- early aa 1961 Torkelaon et at. reported that 478. -onsclousness at extremely high concentre- abnormal histologic changes were noted in Bernstein, I. L., "Medical Hazard* of Aero .Iona, inhalation of a 3.5% concentration of the livers of rabbit* after repeated exposures sols," Postgraduate Medicine, December vinyl chloride can cause dizziness, diaortente- to 300 ppm of vinyl chloride. Slight liver 1973. pp. 62-66. Mon and headache (ILO. p. I486). At an 8- enlargement was noted at dose* as low a* 100 "Consumer Packaging", Chemical and En .2% concentration cardiac orrythmlaa hare ppm (Torkelaon et al.). gineering News, April 13, 1971, p. 23. been observed In experimental dogs (ACQIH. A 1967 French study of 166 workers en Federal Register, Vol. 36, Jio. 105, May 39. p. 477). The Committee on Aerosol Toxicity gaged In the production of FVC found liver 1971, p. 10606. haa voiced ooncero over the use of certain enlargement in 30% of the case* studied Federal Register, Vol, 38, No. 95, May 15. gases--Including vinyl chloride--aa com (Suciu et al.). 1973, p. 12931. ponent* of propellant/solvent system* in A later report of the health experience of Federal Register, Vol. 36, No. 134. July 13. aerosols because they are capable of produc Dow Chemical s vinyl chloride workers re 1973, p. 18684. ing "cardiac sensitization" (Committee Re vealed no overt Illness, but did determine Federal Register, Vol. 39, No. 21, January 30. port, p. IB), that certain blood tests of liver function 1974, p. 3874. B. Evidence of Carcinogenicity. On Janu (e g. beta Uproproteln. the Icterus Index, and International Labour Organization (ILO), ary 33,1974, the B. 7. Qoodrich company an bromosulfalatn retention time) were abnor Encyclopedia of Occupational Safety and nounced that three--and It 1* now known mally altered. On the basis of their findings, Health, 1973, p. 1466. five--of Its Louisville, Kentucky, vinyl-chlo ths authors concluded that some degree of Kubier, Hans. "The Physiological Properties ride workers had died of angiosarcoma (or liver dysfunction might result from a TLV of Aerosol Propellants." Aerosol Age, April hemangioendothelioma) of the liver, an ex for vinyl chloride of 300 ppm (Mutchler et 1964. pp. 44-50,90-91. ceedingly rare form of liver cancer. The five al.). Maltoni, Prof. Ceeare, Instltuto dl Oncologies, deaths occurred between 1964 and 1973, with Marxtellar et al. reported within the past Bologna. Italy. Testimony at Department the time of development of liver cancer after few months that 19 out of 30 workers who of Labor Hearing on Vinyl chloride, Feb the onset of exposure to vinyl chloride In the had been exposed to vinyl chloride for 1% ruary 15.1974. four worker* for whom this Information la to 31 years at a PVC producing plant In Marstellar. H. J,, et al., Deutsche Med. Wlrk- known from 14 to 27 years. Germany bad some type of liver disease, in schaft 98:2311, 1973, cited by Dr. Irvtng The National Institute for Occupational cluding gross changes of the liver and spleen. Sarety and Health, estimating that only Direct Inspection of the liver and spleen (by Sellkoff at February 15, 1974, Department ot Labor Hearing on Vinyl Chloride. twenty to thirty people die In the United surgical operation) showed disease to be Mutchler, J. X., Kramer. C. Q., Report on States every year from this particular type present In 14 out of the 30 workers (Marstel- Relation of Exposure to State of Health ot of cancer, has announced the discovery of a lar et al.). Dow Chemical Workers, Gordon Confer new occupational cancer associated with the polymerization of polyvinyl chloride from vinyl chloride, with vinyl chloride as the chief causative suspect (Statement of Dr. Marcus Key, February 1, 1974). The disease D. Evidence of Other Chronic Effects. In October 1963 oeteolytlo lesions were first ob served in two Belgian plastic* worker* who were also suffering from Raynaud'* phenom enon due to constriction of the local blood ence, Tilton, New Hampshire, August, 1968, cited in Documentation of Threshold Limit Valuet, p. 278. Report of the Committee on Aerosol Toxicity. is invariably fatal, once cancer haa been Ini vessel* bx their hands (ILO, p. 1466). This August 4,1973, p. 19 (Chairman: Dr. Albert tiated (Statement of Dr. Irving Sellkoff, Feb ruary 15. 1974). The carcinogenic effect* of exposure to vinyl chloride have been demonstrated by Viola and Maltoni, In separate experiments. hand syndrome--termed acroo*teoly*ls--has slnoe been observed in over 30 worker* In the United State* employed In the manufacture of PVC reams (Wilson at al.). VII. Relief Requested. We request that C. Kolbye. Jr.) Samuels, Sheldon. Industrial Union Depart ment, AFL-CIO, Testimony presented February 16, 1974, at Department of Labor Viola produced angiosarcomas of the liver in rats when exposed to 30,000 ppm for 4 hour*/ day, 5 days/week, for 13 months (Viola, p. 30). Maltoni has produced the same type of cancers when exposing rats to much lower doses (Statement of Prof. Ceeare Maltoni, the Chairmen of the Consumer Product Safety Commission declare aerosolized con sumer products containing vinyl chloride to be "banned hazardous substances," under the definition of 15 CSC. 11361 (q)(l) and under the authority granted the Chairman Hearing on Vinyl Chloride, citing figures supplied by Industry sources. Sellkoff, Irving, Professor. Mt. Sinai School of Medicine, Testimony at Department of Labor Hearing, on Vinyl Chloride, Febru February 16, 1974). After 137 weeks of ex In I 1363. Moreover, under the authority of ary 15,1974. posure to vinyl chloride (4 houra/day. S days a week, by inhalation). Maltoni reported liver tumors In Sprague-Dawley rats at exposure* as low a* 350 ppm. (See table below). Resclts ov Maltomi's ExnumNTAt Srcov 1 1365. the Chairman 1* requested to remove from sale such consumer product* contain ing vinyl chloride es propellant* and to prohibit the introduction of such aerosolized product* containing vinyl chloride Into In Suciu, I,, Drsjman, L, and Valaskl, M. "Etude dee Maladies due* au Chloruro de Vinyle." Clinique dee maladies professionalcs, Vol. 58. No. 4.1967 (English abstract.) Torkelson. T. R-, Oyen, F,, Row*. V. K,, Forworn lev*!-- vinyl chloride, l>r inhalation Number ot animals exposed NtunbArof urimils Morini tt*r nfln--irrumi terstate oommeroe. Amer. Indust. Hyg. Assn. 33:354 (1961), The chronic toxicity and evidence of car-_ cited in Documentation of Threshold Limit dnogenicity of vinyl chloride monomer for' Values, p. 377. humans ha* been documented by scientific Viola, P. L, "Cancerogenie Effect of Vinyl studies and clinical reports. Further use of Chloride," Abifr. loth. International Gen 10.000 2.M) ppm_______ 900 ppm------------- > 280 ftprn.i. s 72 74 07 67 M 6 vinyl* chlorlds monomer es a propellant for 11ft 7 aerosolized consumer product* must be pro hibited slnoe there Is no evidence that hu I man belnga can eafely be exposed to th* 0 chemical. oa' Congress, Houston. Tex*s (1970), p. 20. Wilson, R. H., et al. "Occupational Acroo- steolyals: Report of 31 Cases,- JAMA, 301:877-581,1967. [FRDoe.74-11936 Filed 5-33-T4;8:45 am] 1*0.101--Ft. I- HDHAL tECISTft, VOL 37, NO. 101--TNUItOAY. MAY 13. 1974 UCC 083565