Document O3XZaKEKownbY9e6JYowb6MwK

14896 DEPARTMENT OF LABOR -------1). Some of The espertments have 4. Additional tdformatton. On April 16. been and others are still on 1*74, information and data were pre f Occupational Safotyand Health going. The experimental results reported sented to TipnieiintiMni of OSHA. Administration were that tumors have been obeerved in NIOSH and the KPA by the industrial ^ [ 29tFR Part 19M ] " [Docket OSB-M] . grove of antmale exposed to VC at am- Sk>-Test Laboratories, Northbrook, Illi centratiens as low as 280 ppm. No tumors nois. concerning results of mmi were obeerved in the group cf snhnals posme studies with VC. sponsored by the VINYL CHLORIDE Prapoaad ttandatti otpnorm to VC at a of 80 Manufacturing Chemtits Amodation ppm. It also appears that the tirtal num (MCA). Although only preliminary m ber of tumors, as wsH as the numbers nature, these results mealed that 2 out 1. Background, vinyl chloride (chloro- of angiosarcomas of the liver, decreased cf 200 mice exposed to VC concentrations ethene) Chemical Ahetracta Service as the concentrations of VC were reduced of 80 ppm for 7 home a day, five days a Reelatry No. 7S01S, is a synthetic chemi to 250 ppm Another experiment by Pro- . weak, for approximately 7 months, de cal made by oxychlorination of ethylene feasor Maltonl was reported underway veloped aafcloeaieoBias of the liver. or by hydrochlorination of acetylene. It involving the exposure of 300 The Industrial Bio-Test Lab data in Is the parent compound of a series of to VC at concentrations of 50 ppm in dicate that exposure to VC at 80 ppm themoplastic resin polymers and co order to assess in a more definitive way may well constitute a serious health has- polymers which are widely used for con whether that level of exposure produces ard to employees. Ako, the question of a tainers, wrapping film, electrical insula tumors In Data reported by safe level of exposure for humans can tion, pipe, conduit, and a variety of other Torkelson, C ."en and Rowe (American not be determined at this time, and may products. Vinyl chloride has been made Industrial Hygiene Association J 22 : 284- continue as a matter for scientific de commercially in this country since 1939 381 (1991)) indicate that exposure to liberation for many yean. We therefore and present production is in excess of VC at concentrations of 50 ppm failed to conclude that it Is now neoeesary to pro seven billion pounds per year. induce tumors in rats, hamsters, rabbits, pose to change the 80 ppm leveTestab- Vinyl chloride (VC) is a gas at am and dogs. Ushed in the ETS to as low a level as can bient temperature and pressure and Is a The employees of the B. P. Goodrich be detected using methodologies outlined chlorinated hydrocarbon which has phumioai Company who died from angio in this proposal. moderate liver toxicity. The previous sarcoma of the liver had an average ex (5) The proposed permanent standard. standard set a ceiling value of 800 parts posure of approximately 19 years to vinyl The requirements for a complete stand per million (ppm) (29 CFR 1910.93, Table chloride, at unknown concentrations, ard under section 8(b) of the Occupa 0-1). On January 22,1974. the Occupational Safety and Health Administration (OSHA) was Informed by the National Institute for Occupational Safety and Health (NIOSH) that the B. p.. Good rich Chemical rinwipany reported that dfrsttii of several of its employees from a rare Hver cancer (angiosarcoma) may have hen occisiattonany related. As a result of this notification and after con sultation with the National Institute for Occupational Safety and Health (NIOSH). and a Joint inspection of the plant by OSHA, NIOSH. and the Ken tucky Department of Labor, a fact-find ing hearing an pomUrie hmsards involved with the manufacture and use of VC was announced an January 30: 1974 <39 PR 3874) and held on February 18,1874. 3. Carcinogenicity of VC. Information produced at this hearing demonstrated that exposure of laboratory animals (mostly Sprague-Dawley rats) to VC by Inhalation at and below the then current OSHA standard of 800 ppm induced tumors, including angiosarcomas of the liver. Professor Ceeare Maltonl, of the Institute dl Oncotogla. Bologna, Italy, reported on a aeries of experiments an the effect of exposure of rats, mice, ana hftmsten to VC it concentrations of 10,000; 9.000; 2.800; 800; 280; and 80 ppm lor varying periods of time (TR- and variable exposures to other volatile (TR 93). Some employees of Union Carbide, Firestone Tire and Rub ber, and Goodyear were also reported fit post-bearing comments to have had ex posure to vinyl chloride and to have died from angiosarcoma of the liver. Finally, Mitnpdee of four deceased employees re vealed liver MiftnmiTM tumors were histologically i~wMwgmsmhto from the angioearcoma tumors obeerved In Professor Maltonl's experimental 3. TKe Emergency Temporary stand ard. On the basts of all information available at that time, and the fact that employees were being exposed at levels around the experimentally observed ef fect level ef 280 ppm an Bneegency Temporary Standard (ET8) was promul gated on April 8. 1874 (39 PR 12842) as 29 CFR 1910.93c. This standard reduced the level from a celling of 500 ptxn to 60 bbri c*uiM. it was comIj nootoiiid mat this standard limiting manures to a 60 ppm level was intended to be a ten tative, interim standard, to be m effect no longer than six during which time the whole question of possible safe exposure to VC would be reoentidered more fully and In the light of more in formation, especially results of experi ments which weds known to be under way at that time. tional Safety end Health Act of 1970 are much more comprehensive than the provisions of the STS promulgated on April 8. The following proposals are re sponsive to additional information on the carcinogenicity of VC, and the requirements of the Act. A. Level of exposure. The proposed standard for employee exposure is set at no detectable level, as determined by a --"i*11"! and analytical method capeibie of detecting vinyl chloride at concentra tions of 1 ppm with an accuracy of 1 pom80 percent. Although more sensi tive methods may be available now or in the future, the methodological sensitivity proposed appears to be the most feasible and gmferally available. A of J ppm sensitivity has been recommended to OSHA by NIOSH. To wUniwn-- the number of persons at risk, a require ment would be established for regulating areas where vinyl chloride is manufac tured, reacted, stored, handled, released, repackaged, dr used. iMimiing opera tions with polyvinyl chloride containing detectable levels of vinyl chloride. Acoees to the anas would be limited to authortied employees. B. Monitoring, a program of monitor ing would be required to establish whether there are detectable levels in regulated areas and to permit determina tion of employee exposures on an in dividual basis. Provision would also be HDCRAi. MONTH, VOL **, NO. VJ--NIOAY, MAY 10, 1**' OLI 923 1*#7 mad* for n hwIiiiiIIi to ab9WV9 monitoring by 9Hi|flmem or tlMtr dmlg- rmtadrsigaemitattrta.m requiredJby 99c- tton 0(c) ( of tb Act C. Control method!. WhorsTdotoctabl*' an airat vtayl chloride levels of VC in mmfitand. two pto- the release of vinyl chloride. analytical nmi would 1m Mand! in nitaMr- Accordingly, lnc ud wort practice pngram tomttaM (e), md (> of levels bslow dotictibiUty; and whfls this Safety and Health Act of 1379 (M toon-going, a respiratory protection pro Utt, UN, UN; 39 VAJC. gU. 917), fco- gram for employees tn the regulated am. rwtary of Labor* Order Ita. 12-71 mm Btctatecring control* and work prae- ctm) end at cm rut ltn, n n bmetton an fmnd methods at onmphsnoi hy proposed to amend IP CNN rut 111* beceosc they toad to evotd oontamtoa- by revisinf 11910JSq u set forth of Health, and Welfare to act for i tton of the emhtent air to tha wortplaoe. Written data, views, Accordingly, It ia proposed to nqutrc tha wwmhiIih the re laatttutlon of mgtaeertag oontrala and of workpraetioe methods es soon esfeetitala, and to require the nee of respirator* pandlac tha taatttotloo of aueh oantma. to supplement such oontroia when they an Jnaufflcint to nduoa oanoantrattone of Thirl chloride below the detectable to the Docket Room no. 1739 If Street, K.W. tienal Safety and Heelth tton, Washington. D C. 10110, post marked not later than Jim# 10,1074. Pursuant to 19 CVft 1011.11 (b) and (e), Interested paraona may flu ohjeo- sulting tat tha relsass of vtayl chloride Into areas ououptad by wnrOnTees (0) "Exposure" awns actual contact1 wttb vinyl chloride whan unprotected by required psrecnal protective equipment and clothing. (10) "Fabricated product" means a level# in spectBari work situations. and ttone to the proposals, rtquaeting an In finished product or part of such product, to earn of emergency. The proposal for formal hearing with remeet thmsto, hi made of polyvinyl chloride, mtirely or in continuous flow and pressure demand aocordanoe with tha following condi part, Including eeoalftatehot types of respirators la baaed on the rec tion* : such as film, sheet, block, bar, or ommendations of NIOBH. which has ob (1) The objection* must Include tbe served leakage through chemical car tridge respirators at high concentrations of VC. A requirement would also be .estab lished for the provision and use of pro tective clothing for employees tn the reg ulated areas. The protective clothing would mutfaiu-- skin contact with' VC vaoor. and would orovlde some nicefilm of protection from splash at liquid in the event of a splll or rupture at equip ment. rood, beverages, and Ilka products would be prohibited in the'regulated area. Written operational and emergency plane would be required, along with em ployee training in routine and emergency duties. Specific requirements Would be established for emergency actions and for routine maintenance and decontami nation operations, including vessel entry, which are known to present particular haaards. v The purposes of operational and emer gency plane and training are to apprlae employees of the hasUrds to which they may be exposed, of the precautions they must take to avoid such haaards, and to rehearse employees in tbs procedures they must follow tn emergencies. D. Medical nrveOance. Comprwhen- tive tor amptoyoe medical examinations are proposed. Including necessary tmta suld- anee is Included for tbs convenience of phyirtam The proposed requirements have been *--wiii to OBHA by NIOfiH aa reasonably appropriate tp de tect liver dysfunction which may be In dicative of. or predisposing to, the de velopment of liver angiosarcomas. X. Recordt and report*. Reoords of monitoring, medical examinations, and entry to regulated areas art proposed, with provision for access by appropriate 06HA and NI06H Specific pro name and addnm of tbe objector; (2) The objections must be post marked on or before June 10.1074; (S> The objections must verify the provisions at the prcpoaad nils to which objection is taken, and must state the grounds therefor; (4) Kach objection must be separately stated and numbered; and (5) The objections must bs accom panied by a summary of the evidvoe proposed to be adduced at the requested hearing. As revised, f 1010.03a would teed as follows: 11910.93q Vtayl Chloride. (a) Scope and application. (1) This lection applies to any area or oouattan in which vinyl chloride (chloroethme). Chemical Abriracte Sendee Itegjstry lto. 70018, is manufactured, reacted, re leased, repackaged, stored, or used.tachiding areas and operations tavoMng polyvinyl chloride where detectable levels of vinyl chloride are rwlsesad. (3> This section does not apply to tbs handling or use of fabricated products made entirely or in part of polyvinyl chloride. (b) Definition*. (1) "Assistant Secre tary" means tbe Assistant Secretory of labor for Occupational ffiafSty and Heelth. VA. Department of labor or hie (2) "Authorised employee" means an employee whose duties require him to be in tbe regulated area and who has hew specifically eerignert fay tha employer; and any employee who enter* such an area as a designsted isprssmtettvs of employee* to MMCttoo an opportunity to observe monitoring and measuring at vinyl chloride. (3) '-Closed container" moans any container which prevents the release of vinyl chloride to the mvlronmant. Director for the Occupational Safety and Haaltb Administration Area Office hav ing Jurisdiction over tbs geographic area tat which tbe establishmeqt b located. (13) "polyvinyl chlmlde" modus nolyvlnyl chloride homopotytoer or copol ymer before such Is converted to a fab ricated product. (13) "Protective clothing" means clothing protective against vinyl chlo ride. (14) "Vinyl chloride" moans vtayl chloride monomer.r (10) "Waste resin" means any resin or ptber reaction produets removed tat tha cleaning of equipment, such as ves sels and piping. (e) Reference. CoOage of American Pathologists. 330 N. Michigan Ave., Chi cago. Dttnols 00001. (4) Regelated area*. (1) A regulated area shall be sotahUshod where (1) vinyl chloride Is manufhetitred, reacted, rel(a1A1)Mdp.o^rtvDtAacyklAfctehdto. riAdemcaipatwble of'rea? leasing detectable level* of vinyl chlo ride to manufactured, reacted, released, repackaged. stared, or used. (2> Access to regulated areas shall be limited to authorised isnplnjiss (3) A daily roster of employees enter ing regulated areas shall bo mads snd maintained. The rosters, or summaries thereof, dull be kept for at toast 20 (a) Monitoring. (1) Every regulated shall be monitored for detectable toreta of vtayl chloride. (3> Tha monitoring titan amuse that any exposure may be determined for each authmiaed employee with a eonfittonoe tovel of 00 percent (3) ffiuptoyosi or thrir designated repimwntaUvm shall he afforded an opportimtty to ohasrve monitoring and measur visions for employee secern to monitoring (4) "Contaminated- idtane capable ing required by this paragraph. reoords are included, as weD as the re of releasing a detectable level of vtayl (D Wbme exercise of an opportunity quirement to furnish a copy of a medical chloride. requires mtry to an area where tha use No. 93--Pt. I----- .10 Konui twitns, vot, tf, no. n--meAr, sur ie, iys OLI 924 of protect!!* ntetfalng. 'forming the to: (A) ntom on related to the * evaluation of particular monitoring aod (D) Reoelve calibration aad /motion monitoring aod measuring petfoonedonalte; aad <) IPremtno instruction* ate related to for In*, <4) Accurate aod complete records of dun be made for not tee than bo rears. Such a record ehall (I) state the date of neb monitoring and the lerels determined; aod (H> identify the Instru ments and methods used. if) ZwptoeeriMp control* and markpractice methods. Cl) Where detectable tetle of vtnyt chloride immediate protection than be against exposure to vinyl chloride by the use of engineering controls, wo*bpi settee methods, and rentxaton as follows: (I) Feasible engineering oontrola and wortpractlce methods shall immediately be need to reduce airborne eoneantrattene of vinyl chloride below the detect able level; (II) Wherever which can be instituted'Immediately as* not sufficient to reduce conconteettens at vinyl chloride below the detectable level, they Shall nonetheless be used to' reduoe the concentrations to the lowest prac ticable level, and shall be supplemented by at reaptmteS In accordance with paragraph <g) of this section; (1U> Wherever no feasible engineering control or worfcpisettee method can be instituted immediately, Immediate respirmtery protection shall be provided in accordance with paragraph (g) of this (tv) Jh any ease oovered by paragraph (f)(1) (ID or OH) of this section, the employer shall also imdsrtake as soon as practicable a program to reduoe airborne oaooen(rations of vinyl chloride below the detectable level, or to the greataot extent feasible, eotety by means at engi neering controls and vmrtpracttee meth ods and as aoon as feasible. (It) A comtdnsthw type "C" i ous flow respirator and a seif-contained hnathlng ap paratus operating In the (h) Protacttoe clothing. (1) ; marine xamlatad areas riiall be tided full-body proteettve clothing, fopt- at no oast to them, and required to wear It while In tho nvteted area. <1> what* pteyvtayl chloride _ containing detectable lerels of ihjl chteride Is empteyeas also ho; (!) Provided and snouted to (Id) ltequted to riarwer after the last exit of tfaa itey- - -CT) Cleon protective clothing shall be provided whonr soiled, bat not CctoUmimlvd doibt&c dnB tv dooontemlnetort brier* reuee by nmaul for laundering or "tm1 O) Mamma fadUtta* oad procSfcss. (I) Where employees an requted by this section to ..................... am bo. 11410.141(e). < this section to shall be provided bo f 1411.141(d) (V. (> prohibited in regulated areas. (H) miniOil Vi*.... . mlA Bit upturn In lecwirtlhm and svaluattco at -si*1--- and -viiteh may In the idem of vinyl chloride; <I) Hie puipoee far and appUcatten at mmcBte test aid prwtdtum and prac- <J) A review at lUs SOttTM, VOL sv, NOl ft--suioav, aiav V, 1W4 OLI 925 oomuouiD MONMD MUI (tt> i to potnittil 1 . (4) Containers of poJjrrtoji chloride <fr) of Mood transfu- --datactaMs Mi of vtiiyt Mdorids aboil bo labeled: FOtiTTOffL CMLCMPO oowtaiho Tnnii oinonw VQT1L OVOBDR B A Mined and equipped for rot and 1 obenTia _ . i m the of Initial i icf acraanlac,ai , Broil be obtained tor i to the following 1 XTBDtQ AMD for HfMnwtf for Mp In the evrot the i of liver function: roiptayea expsrtwvws psobtama Ubdw (1) total MHruMn; (I) Containers of vinyl chloride aboil ififh tht dbetmt ^ nal for help, and than ns* roter to sseist (U) Alkahns phosphatase; (!H) Seram glutamic oxalaoetic ti vwn the employee unto another petaon Is --------- (BOOT); promt to observe. Or) Ssrmn gtwtamtr pyruvic ti ,7 HAMMABLI (US (m) Transportation loedhig and *- antfroee (SOFT); and loading. (1) IticfllMei tor the loading (v) Oaa MAT muBivt WITH and ct vinyl chloride to and (oonv). from containers shall have each Mmfxr (4) aAstsuMi tacts that may option v FOIBOH line AM fmoi- uuiititrn Hot oajpptd ally be conektered far use In "HCIBSUBl'It'f AQBMT AMD with vent eouaactions, and shall Imva ambbtbbttc______ an inert gas purging system. Vent and ABSOKBXD bt bbbathwo AMD THBOOQH BUM purge eguent ehaH be returned to a procees stream or flared In a safe location (6) No stotoment shall appear on or, (2) Procedures shall be developed and noor any required sign, label or instruc implemented far the transfer of vinyl (iv) Platelet count. tion, which contradicts or detract# from chloride. Written copies of such proce () Laboratory analyses for all MMflgl- the effect of any required warning. In dures shall be provided employees en oal specimens ewiiiAiii m medical exam formation or instruction. gaged In such operations, and such em inations shall be performed in labora (1) Maintenance and decontamina ployees Shan be fully Mined and re tories accredited by the College at tion. (1) --"rhMU dell be placed upon hearsed In ell procedures. ( American Pathologists or licensed under Immediate clean up of spills, periodic In (3) Bnployees engaged in transfer op spection. prompt repair of equipment and erations Shan be provided w*h and leaks, and proper handling, storage and required to wear roepliaton M accord dlirrTM* or decontamination of materials ance with paragraph (g) of this section. to prevent airborne contamination and (n) Polymer handling operations. (1) acrtdantr1 ain contact with vinyl chlo Container* of polyvinyl chloride releas ride. Waste materials, equipment, and ing detectable levels of vinyl chloride other sources of vinyl chloride In closed shall be opened and transferred only containers, may not be placed in areas of excessive temperature or sunlight since build-up of internal pressure may result under (m*1 tirhftiift ventilation which reduces the ocnoeotration of vinyl chlo ride below the detectable leveL in rupture of the container, fire or explosion. (2) Waste resins or other materials with vinyl chloride shall be placed In tinned containers pending dis posal Or - (3) Appropriate procedures shall be developed and implemented for the de contamination or disposal of all such waste material. (4) m or repair opera (2) Hot operations, such as but not limited to milling, nnd ex truding, which roleeae detectable levels of vinyl cbloridt, shan be carried on only ttodtr leowrcw^arool irozrah^wf^wtiei^crowt m-- rontemfsl^f^t^wtiPkvrioin Mehwnawemn reduces the concentration of vinyl chlo ride below the detectable M. (o) Medical enrveWance. Mot later then ---------------- - 1*74, a program of medical survelllanoe ahall be matt- tions on nontsmlnstisd sTttimii or eaulnment. tiinMne vesMl entry, em ployees engaged in such operations shall be (1) provided with and required to wear and use a whole-body air-supplied suit impervious to vinyl clticrtrte. and a respirator in accordance with paragraph(g) of this section; end (11) required to shower after removing protective equip ment. (8) Protective clothing and equipment tuted, and shall proylds each authorlasd employee with an opportimtw for ex aminations In accordance with this para graph. All medical examinations procedures Shan be performed by tM nmei i IsInn of a Doctor of lfedklne (HD) or Doctor of Osteopathy (DO). AH medical examina tions and tests shall be provided without cost to the employee. (1) At the time of Initial employment, shall be clean and dry for each use. or upon institution of screening, a physi (g) When vessels or piping systems are cal examination shall be performed with opened local exhaust ventilation shall be pacific to detecting silorso* provided to remove the eecaplng vapor ment of liver or Mean by 43 CTO Part 7A '(g) Xf the results of serening required In paragraph (o) (3) of this section are normal, serroning shall be repeated: (i) Every six months for employees who have hero employed In vinyl chlo ride Mated operations for 10 years or more; and (11) Annually for all other employees entering Tegulsteri area#. (7) If one or more liver function tests performed are abnormal, serum testing Shan be repeated as soon as possible, preferably within two to four weeks. XX no abnormalities an present upon reaereeufng. serum --**-g shall be re peated In three months. (g) If abnormalities persist upon re maining, the employee shall be with drawn from areas whan contact with vinyl chloride is possible, and an Individ- medical workshop shaU be inBugsrotid as Initial steps are a physical exsmtnstinr and varispedal procedures such as broattUs B antigen determination and Uver scanU liver function ahncrmeWlee are to he unrelated to Uver (ba the roipioyee may be permitted to return to vinyl chloride-related emstoysorot, subject to -Individual medical valuation. () A complete and accurate record of the results of medical examinations shall be mads and maintained for the dura tion of emptoymrot plus Sve years, or for 30 years, whichever Is longer. from Ml occupied areas. (p) Accords. (1) Reoords of monitor (7) (1) Vessels to be entered shall first be ventilated and monitored so that the concentration of vinyl chloride is reduced to a level within the protection factor (2) At the time of Initial employment or upon institution at screening, and an nually thereafter, a history checklist shall be completed fay the roi pioyee. This Hit than Include questions ing and measuring, medical records, and regulated area rotry roster* aad sum maries, shall be made available for ex amination and copying upon request to authorised representatives of the Astist- capability of the protective equipment concerning: ant Secretary aad the Director. MMMI. SSOtSTBL VOL 3f, NO. W--MOAT, MAT It. 1V74 OLI 926 (X) Z& the cea-- to do shall be*tH^SSadllllg%lrtaiaa mall (), <), um4 ), a um. im <m ojux oh. atb: labor's 0dwife. 1B-T1 (M f V7M)) dwllU^ItTC DC. We *th ^ p tttf iDdl* Ideally notified In wrlttnt ef this [TB DotTt-lcrTU (4) shall be pro- Tided aooss to I son opr records reflectinc tbsir own < (U Upon mitten wwa of nr em- plena, a copy of the medical wart at emh employee 4a& be famished to a physician desicaated hr the employee In W Report*. (1) Not later than .... _____ th* MknrijK Mo ha reported to the OSHA Ana Director. Any chance In such information ahafi be reported to the OSSA Area Director wttbhi id days of sacb chance. . (1) The addram and location of each establishment which has one or men recnlated areas; and <11> The sootier ef employees in each recedeted area dnitag normal operations, twtee^ mrichnanee. <t) incidents which result hi the re lease ef atari chloride tate soy ana where employees may be txpoeedshah be reported In accordance with this paracraph. <l) A report of the oocaience of tbe tucbhnt and the facts obtainable at that time tarfartfng a report aa any medical treatment of efTeetad employees stud be made within 34 hours to tbe i (11) A written report shall be fifed with the OSHA Area Director srNhta 19 days thereafter and shall ta ut) A specification of the sneimt of material releassd; (B) A description of the area Inspired and the extent of known and peUmttal employee mpoaure and area effected; <C)-A report on any medical treat ment irf aCscted employeea and any oaminanoe procram CD) An analysis of the < ef the tatadrnt, and to be taken, with data, to aaotd ftorttw timfler <> Upon oomplettonef any mcmltortac and measartnc which dtacloi that any amptoyoe has aetnally bean exposed to detectable levels of vtayl chloride, each antib employee shell be indtrldneJly noti fied in writing. The notice sbefi: <1) Be delivered not later Otan 10 wmfttad days after completion of the mcnltoiinc and meanutap; til) Btata tbe aetaal aoMmue In 1 <lh) State the atepe wUeh have 1 takm,sn betas taken, and wQI be taken, with specific completion dates, to termi nate tbe exposure and prevent a recur rence. leenn. seaursi. vol se, mo. vs--mAv, may i, itas OU 927