Document X8oeRyN3R5L1bMoKOnm5ZX9QK

16S96 PROPOSED RULES have been occupationally related. As a result of this notification and after con sultation with the National Institute for Occupational Safety and Health <HIOSH>, and a joint inspection of the plant by OSHA, NIOSH, and the Ken tucky Department of Labor, a fact-find ing hearing on possible hazards involved with the manufacture and use of VC was announced on January 30, 1974 (39 PR 3374) and held on February 15, 1974. 2. 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 06HA standard- of 500 ppm induced tumors. Including angiosarcomas of the liver. Professor Cesare Maltonl, of the Instituto di Oncologia. Bologna. Italy, reported on a series of experiments on the effect of exposure of rats, mice, and hamsters to VC at concentrations of 10.000; 6,000; 2,500; 500; 250; and 50 ppm for varying periods of time <TR- 43-63). Some of the experiments have been concluded, and others are still on going. The experimental results reported were that tumors have been observed in groups of animals exposed to VC at con centrations as low as 250 ppm. No tumors were observed in the group of animals exposed to VC at a concentration of 50 ppm. It also appears that the total num ber of tumors, as well as the numbers of angiosarcomas of the liver, decreased as the concentrations of VC were reduced to 250 ppm. Another experiment by Pro DEPARTMENT OF LABOR Occupational Safety and Heaitn Administration fessor Maltonl was reported underway involving the exposure of 300 animals to VC at ccncentrat'or* of 50 ppm, in order to assess in a more definitive way [ 29 CFR Part 1910 ] [Docket OSH-36) whether that level of exposure produces tumors In animals. Data reported by Torfcelson, Oyen and Rowe (American VINYL CHLORIDE Industrial Hygiene Association J 22: 254- Proposed Standard 361 (1961)) indicate that exposure to VC at concentrations of 50 pom failed to 1. Background. Vinyl chloride (chloro- induce tumors in rats, hamsters, rabbits, ethene> Chemical Abstracts Service Registry No. 75015. Is a synthetic chemi cal made by oxychlorinatior* of ethylene or by hydrochiorination of acetylene. It Is the parent compound of a series of .themoplastic resin polymers and co polymers winch are widely used for con tainers. wrapping film, electrical insula tion, pipe, conduit, ana a variety ci other and dogs. The employees of the B. P. Goodrich Chemical Company who died from angio sarcoma of uie liver had an average ex posure of approximately 19 years to vinyl chloride, a-, unknown concentrations, and variable exposures to other volatile chemicals. (TR 93). Some employees of products. Vinyl chloride ruts been mace commercially in this country since 1939 and present production is in excess of seven toiiicn pounds per year. Vinyl chloride (VC? is a gas at am bient temperature and pressure and is a dderinated hydrocarbon which has moderate liver toxicity. The previous standard set a ceiling value of 500 parts per million <ppm> (29 CFR 1910.93, Table 0-1). ter. cud Go_ ."oar v.zve ctso reycitL'd in p^st-hearinir comments to have had ex posure to v.r.;'l <r ^r..1 to 1 -\v= i:cd from angiosarcoma cl the liver. Finally, autopsies o; :aur d.cc..s:d employees re vealed their liver ar-ric-mrccma turners were histologically indistinguishable from the angiosarcoma tumors observed in Professor Ma.tern's experimental animals. 3. Tbc Fnrrcenrii T'rwpowtw i'wrd- On January 22. 1974, the Occupational cri. On the basis ci ail information Safety and Health Administration available as. that time, uni the i:.o: that (OSHA) was informed by the National employees were being exposed at. levels Institute for Occupational Safety and around ihc experimea'.c.Ii/ oLac-rved ef Health *NIOSH> that the B. F. Good fect level of 251 ppm. r.n -.mere;rscy rich Chemical Company repotted that Te:r.:*crnry Stur.daru .-ITS ?;vmul- r>r rf *' , from r'.'-d 'n April 5. re* the level from a ceiling of 500 ppm to 50 ppm ceiling. It was expressly recognized that this standard limiting exposures to a 50 ppm level was intended to be a ten tative-interim standard, to be In effect no longer than six months, during wbich time the whole question of possible safe exposure to VC would be reconsidered more fully and in the light of more in formation, especially results of experi ments which were known to be under way at that time. 4. Additional information. On April 15. 1974, information and data were pre sented to representatives of OSHA. NIOSH and the EPA by the Industrial Bio-Test Laboratories. Northbrook, Illi nois, concerning results of animal ex posure studies with VC, sponsored by the Manufacturing Chemists Association (MCA). Although only preliminary in nature, these results revealed that 2 out of 200 mice exposed to VC concentrations of 50 ppm lor 7 hours a dayv five days a week, for approximately 7 months, de veloped angiosarcomas of the liver. The Industrial Bio-Test Lab data in dicate that exposure to VC at 50 ppm may well constitute a serious health haz ard to employees. Also, the question of a safe level of exposure for humans can not be determined at this time, and may continue as a matter for scientific de liberation for many years. We therefore conclude that It is now necessary to pro pose to change the 50 ppm level estab lished in the ETS to as low a level as can be detected using methodologies outlined in this proposal. (5) The proposed permanent standard. The requirements lor a complete tand- ard under section 6(b) of the Occupa tional Safety and Health Act of 1070 are much more comprehensive than the provisions of the ETS promulgated on April 5. The following proposals are re sponsive to the additional information on the carcinogenicity of VC, and the requirements of the Act. A. Level cf evpesure. The proposed standard for employee exposure is set at no detectable level, as determined by a sampling and analytical method capable of detecting vinyl chloride at concentra tions of 1 pp:r. with an secure::; of 1 ppu:=5C portent. Although mere sensi tive methods may to available new or in the fu; ire. the Tv.ethcdolsg;cal s-: :tjviry l iC'.ioic'i .'j Cw Lit: it*ius.e and gciieiUily avauao.e. A metnoc of 1 p.'m .'ienaiti.i'v c?e:i ltcor-.m ended to OSHA by NICSH. 7-:? immnr.ze the number cf r-;rs:r< at risk. ?. require ment would be established for regulating aro-os where viryi chloride is man uac- tured. reacted, stored, handled, released. i\ enchased. or used, including ou.ej-a- ticcs with polyvinyl chloride containing detectable levels of vinyl chloride. A cress to the areas would be iimatea to a j'.uor- irrd employees. B. .'lonitorinc. A program cf monitor ing would be required to establish whether there are detectable level.-; in rtpuh'.tcd areas and to permit dcter.nhsft- tion oi employee exposures on on in- 33 K> O cn -j cn FEDEBAl BcOISTEt, VOL 39, NO. FSiSiV, h\A; 10. ' *7 --- -*----J .- ^U.s... r -'*. .---. /'..-. _>'*.-'Wy-r.'..'.v-.r'*' -;n. .vx. 1^1 -| Pj|l ] -yiH--* x yjn.t.acani 1 --' v_ ^ PROPOSED RULES made lor an, opportunity to observe record to an employee's physician on the ' '(5) '"Decontamination* meahs~redticmonitoring by employees or their desig employ**'*-request, HjrtaWlshmwitB con tlcn of .vinyl chloride coacentrattopyto nated representatives,-asrequired bysee-; ducting VC operations -would be required lees than detectable levels. ;/j u grams would . .__ . . _ . _ , ____ ... _ ___ , ^Jng and workpiactlce program~toiedpee >6Te) ,*and ~0<cXi4fMbe,*O6cupuannaI '-licnspf *1' yimi^^th^an-aocijgdeyfof* Tevda-beloTr detectability; and while this -Safety.and Health'hciur 1970-(M'Stat. ppm*:50 percents .- - / '>VM^ gbraomngfooirnegm; ap'troeysepeirs*itnotrhye.prreogtre&eatttoemd a'prre6a^.^r1o5t9a3r,y^o59fela.bl5oB8r'rs^'OUr.dHer.aW;oV5^l-aT5IT<>i3,`S*Te7ct- : (7) "Dlrector~ineai6the Dlrebtbrfoa^. atonal Institut^ar-OqeupktidbslSafety :- Knglneering controls wnd work prae^ .and 39 CPK PartTum/it4s Imre-^cand. Health^cr.py>percn'j.flirected-hy^ tices are favored methods of'compliance by proposed to 29CFR Part l910' .him ofthb Secretary:nTSeflth?gduca-. because they tend 46 hvoM containhia-/ hy revising t 1910.93q as set forthbelowl * tion, *hd'Welfarerto artfor^htfDirector/ Bnn y the wW*nt.fTF' Trvt!hir " r Written "Wi-yrrm^nfa* r^n4XT*rKrn*rf*Tir~v~iYT,**rutrnrti,,t,,ifmi, - n>T/ * -*Accordingly,lt is-proposed tdreqatrs the. concerning the. propoealrmsy bemailed >ctrcumsUmce6r!setuf circumstances/ve institution ^engiiiee;lna'ccantrol8 -and to--the DocketOfllcertDoeket>OGH-36I:;?sulting.drL'the ^release^ofninyl-xhlorlde , rOfworkpracticemethodsas soon as~lead-' Boom 230/1726^1 OUeeCJft.W./Occupa- vlnto areas occupied `byjeniployees.Vyf:^'' bEe/tond'tbrequlxe'the uaeot tedptratar^'J^kmalr^ety"nd''Bealth'!iSaihlnlstra^ -<SM0j,iBSBiponire%aneana'aetualAntact, pendlngtheinstitUtKm ofsueh'eantrota,' tiari/ '^ashtogton,^D.C, ^i20210,-p6st^ r,^rtth vinyl chloride whenrimprotacted by =- "f-'Ui to supplement such-controls where they marked hot later thinJune 10/ required personal jroUchve/jBiMUuuent : . . are'lnsufllcieht>tcPiedhce cbhcehtratioDa "^BursuanVto dg-CVB lBlItlt/fcbyiand -tand clothing. *,r g?.-W;r i vinylfchlbrld^h^law*the-'detectable^K^^tereeted'^pereaas 1. ^ rniiiii enTjmi i mi ViiT miil ipi'iijiiweT Tni fiTnii?flTiieViiii e1lir iieiiiiiT`11mnTii/:ii| T msili l>rjiiilji VTTjjT'jliTiifTiltiTTinf ^types^trfrespliwtOTrtfibm^raf^j^^^my^Sqi _ ^-omihendatians'.cif3CTQBH*sdiEhjbaarolpV/^l)ag3>6,;hbJectfc&muSlW^iide1fche ^Boh -- served`leakage^tthtottyir^eaiib^:.C9Br^^Baine nil ai1iliwn~iiif'T1>e'Ji1iJisilnr.ffeiefi~c ^mV ______ __ _ _ _ _ trldgeteepiratorsist nigh''concentrattaha*-^tst3>rtre aobJecttan*i*mart*le^pcei4/DirectorforIbeDcctr of VC.' on anheforeJune 10^1274/: _'^SHeaith^Adiziizilstritiarf'i ^A-requhemort' mninf inw < fru'iilm'i'Tnr Surtsdlctloh'vertt^ Itahed^for^the jiruviskm. tective elothing for empl ul&ted `2was/:rT^:tprotecttTe _______ mrisiii jsitj j homopClyinerScs {E^pol-. -' wouldrhintinii5iiJ*s>dn Icontagt/wlthtyc.^ _ _ _ _ _ _ _ _ ... ... .^ymenAefore^ochdsDconverted 4b a^abr /, Vapor.*^m-nl w' p- uld p--r-p--v- -l-d--e--'s--o--m---e--m*e*atesudr.ea.ndnumbered;nd-^ v - .^ofjprotectioq^frohi.;lspiash.sCEf/lk|Ulxi^3n, .tSX/Tbe .Aiecticns rnmst tfMt^cecnfe'^^1^. . _ _ rimams of W'spillor rupiane Gt^bCfnipi^ -fctTT^Tnnry rf.^elothtega^rotecttya' ifiemy^hhloff; W ?v :-*tfV&aa would hi4required.along:with n^/{ 1910.93q arfaviaadbMaAa>jB s5S^ t*vmyl --SabUs^tor-cwSylacaS^d <r-te^4tep^^o0ege^r >- which aro'known^-presentarticular -,,,v n^myunea,:-^ieactea-;:>reTt _ PROPOSED RULES 16809 VINYL CHLORIDE CONTAMINATED MATERIAL CANCER-SUSPECT AGENT DISPOSE OP OR DECONTAMINATE USING AUTHORIZED FRECB>UR3 (4) Containers of polyvinyl chloride containing detectable levels of vinyl chloride shall be labeled: POLYVINYL CHLORIDE CONTAINS VINYL CHLORIDE VINYL CHLORIDE IS A CANCER-SUSPECT AGENT ABSORBED BY BREATHING AND THROUGH SKIN (5) Containers of vinyl chloride shall be labeled: VINYL CHLORIDE DANGER EXTREMELY FLAMMABLE GAS UNDER PRESSURE MAY POLYMERIZE WITH EXPLOSIVE FORCE POISON CANCER SUSPECT AGENT AND ANESTHETIC ______ ABSORBED BY BREATHING AND THROUGH SKIN (S) No statement shall appear on or near any required sign, label or Instruc tion, which contradicts or detracts from the effect of any required warning, in formation or instruction. (1) Maintenance and decontamina tion. <l) Emphasis shall be placed upon immediate clean up of spills, periodic in spection, prompt repair of equipment and leaks, and proper handling, storage and disposal or decontamination of materials 'to prevent airborne contamination and acrid9"tjl *Wr> contact with vinyl chlo ride. Waste materials, equipment, and other sources of vinyi chloride in closed containers, may not be placed in areas of excessive temperature or sunlight since build-up of internal pressure mar result in rupture of the container, Are or explosion. (2) Waste resins or other materials contaminated with vinyl chloride shall be placed in closed containers pending dis posal or decontamination. (3) Appropriate procedures shall be developed and Implemented for the de contamination or disposal oi all such waste material. (4) In maintenance or repair opera tions on contaminated--systems or equipment, including vessel entry, em ployees engaged in such operations shall be ti> provided noth and required to wear and use a whole-body air-supplied suit impervious to vinyl chloride, ana a respirator in accordance with paragraph (g) of this section: and (ii> required to shower after removing protective equip ment. (5) Protective clothing and equipment shall be clean and dry for each use, (6) When vessels or piping systems are opened local exhaust ventilation shall be provided to remove the escaping vapor from all occupied areas. (7> (i> 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 cr.pabiiriy c. `.he prctccti'. e eq'upTV.-ent. (U) When vessels are to be entered, all piping to such vessel shall be: (A) Opened, blanked and tagged: or <B) Where welded piping Is in use. not less than 2 valves in series, which isolate the vessel from any other connection to such line, must be closed and secured. (ill) No employee shall enter a vessel, except when another employee properly trained and equipped for entry is pres ent and is observing the employee in the vessel. The observer shall have means for signalling for help in the event the employee experiences problems. Under such conditions, the observer shall sig nal for help, and shall not enter to assist the employee until another person is present to observe. (m) Transportation loading and un loading. (1) Facilities for the loading and unloading of vinyl chloride to and from containers shall have each transfer line and vapor-equalizing Une equipped with vent connections, and shall have an inert gas purging system. Vent and purge effluent shall be returned to a proc ess stream or flared in a safe location. <2> Procedures shall be developed and Implemented for the transfer of vinyl chloride. Written copies of such proce dures shall be provided employees Migaged in such operations, and such em ployees shall be fully trained and re hearsed in all procedures. <3> Employees engaged in transfer op erations shall be provided with and required to wear respirators in accord ance with paragraph (g) of this section. <n) Polymer handling operations. (1) Containers of polyvinyl chloride releas ing detectable levels of vinyl chloride shall be opened and transferred only under local exhaust ventilation which reduces the concentration of vinyl chlo ride below the detectable level. (2) Hot operations, such as but not limited to milling, calendering and ex truding. which release detectable levels of vinyl chloride, shall be carried on only under local exhaust ventilation which reduces the concentration oi vinyl chlo ride below the detectable level. (o) Medical surveillance. Not later than -------------------- 1974. a program of medical surveillance shall be insti tuted. and shall provide each authorized employee with an opportunity for ex aminations in accordance with this para graph. .-.11 rr.echeal examr.'ncr.s and procedures shuU be periormed by or under the jupervasion of a licensed Doctor o: l--j- 'MU' or Doctor of Osteopathy (DO'. All medical examina tions and tests shaii be provided without cost to the employee. (lj At the time of initial employment, or upon institution of screening, a physi cal examination shall be performed with specific attention to detecting enlarge ment of liver or spleen by abdominal palpation. <2* At the time of initial employment or upon institution of screer.inc. and an nually thereafter, a medical history checklist shell be completed by the em ployee. Thu shad utciude questions coucei-,:;- j; (i) Alcohol intake; (U) Past history of hepatitis: (ili) Past exposure to potential hepatotoxic agents, including drugs and chemicals; (iv) Past history of blood transfu sions; and <v> Past history of hospitalizations. <3> At the time of initial employment, or upon institution of screening, a serum specimen shall be obtained for screening with respect to the following blo-chemi- cal determinations of liver function: (i) Total bilirubin: <ii) Alkaline phosphatase: (lit) Serum glutamic oxalacetic trans aminase (SGOT): (iv) Serum glutamic pyruvic trans aminase (SGPT); and (v) Gamma glustamyl transpeptidase (GGTP). (4) Additional tests that may option ally be considered for use in screening Include: (i) Lactic dehydrogenase: (il> Serum protein determinations; (ili) Serum protein electrophoresis; and (iv) Platelet count. (5) Laboratory analyses for all biologi cal specimens included in medical exam inations shall be performed in labora tories accredited by the College of American Pathologists or licensed under 43 CFR Part 74. (6> If the results of screening required in paragraph <o) (3) of this section are normal, screening shall be repeated: (i) Every six months for employees who have been employed In vinyl chlo ride related operations for 10 years or more: and (ii> Annually for all other employees entering regulated areas. (7) If one or more liver function tests performed are abnormal, serum testing shall be repeated as soon as possible, preferably within two to four weeks. If no abnormalities are present upon rescreening. serum testing shall be re peated in three months. (8) If abnormalities persist upon re screening, the employee shall be with drawn from areas -.-here contact with vinyl chloride is possible, and an Individ ualized medical workshop shall be in stituted. Suggested as initial steps are a complete physical examination and vari ous special procedures such as hepatitis B r-.v.uer. determination and liver scan ning. I: liver function abnormalities are deterrr.ired to bo unrelated to liver dis ease. the employee may be permitted to return to vir.yl chloride-related employ ment. subject to individual medical evaluation. <9> A complete and accurate record of the results of medical examinations shall be made and maintained for the dura tion of employment plus five years, or for 20 years, whichcicr 15 longer. fp' Records, il' Records of monitor ing and measuring, medical records, and regulated area entry rosters and sum maries, shall be maae available for ex amination end copying upon request to au'.horir.ed representatives c:' the Assist- URL 2 0 5 7 7 FEDEtAl REGISTEt, VOL 39, NO. 92--ttlOAY, MAY 10, 1974 16900 PROPOSEO RULES 2) In the even** t-lir.t the employer ceases 10 go business sr.u :.'.ere :s no suc cessor to receive and retain his records for uie rrrej. r '`i'll t.'' trar^:;:.' : . r- r~. .. Srcs. e . C,c'. and 6-o. f4 S*nt. 3-.*.1 I - J wU>.C. tijj. C.'7i; S-CTt '-ITT of L&our a Orue.- Mo. 12-71 (26 FR 8754)) 7: V.'r.-hlrr-cr.. DC. V.-** fth t\ i . ' 1 . itiually notified in writing of tJus transfer. (3) Employees ar.d their designated representatives shall be provided access to examine and copy records cf monitor ing and measuring. f4) Former employees shell be pro vided acces u> examine and copy records reflecting their own exposures. (5) Upon written request of any em ployee. a copy of the medical record of such employee shell te furnished to z physician designated by the employee in aueh request. iq' Reports, fit Jfot later than______ __.__. the lolic7.-Jtg information shall be reported to the OSHA Area Director. Any change in such information ;hah be reported to the OSKA Area Director within 15 days of such chance. (i) The address and location of each establishment which has one or more regulated areas; and ii) Tne number cf employees in each regulated area during normal operations, including maintenance. i2) Incidents which result in the re lease of vinyl chloride into an? area where employees may be exposed shall be reported in accordance with this para graph. <i> A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be ade within 24 hours to the OSKA Area director. (li) A written report shall be filed with the OSKA Area Director within IS calendar days thereafter and shall in clude: (A) A specification of the amount of material released; (B) a description of the area involved and the extent of known and potential employee exposure and area affected; (C) A report on any medical treat ment of affected employees and any medical surveillance program imple mented; and (D> An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases, <3) Upon completion of any monitoring and measuring which discloses that any employee has actually been exposed to detectable levels of vinyl chloride, each such employee shall be individually noti fied in writing. The notice shall: (i) Be delivered not later than 10 working days after completion of the monitoring and measuring; (li) State the actual exposure In terms of concentration end time; and Oil) State the steps which have been taken, are being taken, and will be taken, with specific completion dates, to termi nate the exposure and prevent a recur- -nee. Aszis'.crtt Sccrcza^ o; Lc,i>or. IFft Dce.74-;Q74S ruel 5-9-74:8:45 ami KoiiAi seotsn*. vol je, no. *2--mjday, mat 10, 1*74 i' \ URL 20578 URL 2 0 5 7 9 i i:.J2 PROPOSED RULES DEPARTMENT OF LABOR Of::-! '.*' ?--**> -- ''J-- Aom:r.istraticn aud Health Administration. 1726 M m7*v ;CG v..-. DC [ 23 CfR Part 1S39 ] STANDARD FOR OCCUPATIONAL EXPOSURE TO VINYL CHLORIDE Notice of Intent To Prepare an Environmental Impact Statement The National Environmental Policy Act of 1S69 (42 U.S.C. section 102) reauires earh Federal scenev to consider the cnvircr.rr.tjnral effects of proposed ac tions and to prepare environmental im pact statements on major actions affect ing the quality of the human environ ment. Accordingly, the Occupational Safety and Health Administration. U.S. Department of Labor, in conformance with its procedures for environmental impact statements (23 CFR Part 1999), announces its intention to prepare an environmental statement assessing the specuon at the OfLce of Standards Development. Ween the draft environmental impact statement or. vinyl chloride is completed, copies will be available to any member of the public who requests it. A 45-day period will be allowed for the public to submit their comments. Signed at Washington, D.C., this 18th cay of .April lyTi. John Stexper. Assistant Secretary o/ Labor. (FR Doc.74-#300 Filed 4-23-74:8:43 *m| impact of a proposed standard for occu pational exposure to vinyl chloride to be published in the Feoeral Register in the near future. The Office of Standards Development, Occupational Safety and Health Admin istration. is currently collecting infor mation and data on possible environ mental impacts of the proposed stand ard, such as any adverse environmental effects which cannot be avoided should the standard be adopted; alternatives to such a standard: the relationship be tween local short-term uses of man's en vironment and the maintenance and en- * ueureut of long-term productivity; any irreversible commitments of re sources which would be involved if the standard be implemented. Those issues of particular interest are: a. Any medical or toxicological evi dence which indicates that exposure to vinyl chloride or its polymers produces adverse effects to living organisms, es pecially primates. b. Current and historical levels of oc cupational exposure. c. Combustible characteristics asso ciated with vinyl chloride or Its polymers, especially Information correlating acci dent experience; damage to facilities, in terruption of plant activities, and/or. storage and shipment difficulties. d. Identification of the uses of vinyl chloride or its polymers, through finished products, and determination of the quan tity of use. e. Any information suggesting substi tutes for vinyl chloride or its polymers, to include estimates of the extent to which substitution is feasible. f. Any suggested actions which will control the health hsxaxds associated with production, storage, or shipment of vinyl chloride or its polymers through finished products. g. Any other pertinent information. Any person having Information or data on this subject which Is not readily avail able in the open literature Is Invited to submit It. with accompanying documen- / on. to the Director. Office of StandV 4 Development, Occupational Safety FEDMAI UeiSTK*, VOL 5*. NO. SO--WEDNESDAY, AFRIl >4, 1V74