Document gnDppB29ZvRLp6Xr68Rbxwvq

l 14Z RULES AND REGULATIONS Title 29--Labor 50 ppm, in order to assess in a more rary standard. In a telegram to the As CHAPTER XVII--OCCUPATIONAL SAFETY definitive way whether that level of ex sistant Secretary of Labor, received on AND HEALTH ADMINISTRATION, DE posure produces tumors in animals. Data or about March 14, 1974, the President PARTMENT OF LABOR reported by Torkelson, Oyen and Rowe of the United Rubber Workers Interna PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS (American Industrial Hygiene Associa tional Union urged the establishment of tion J 22:354-361 (1981)) indicate that an emergency temporary standard for exposure to VC at concentrations of 60 VC. During the hearing of February 15, Emergency Temporary Standard for Exposure to Vinyl Chloride ppm failed to Induce tumors in rats, 1974, the Industrial Union Department, hamsters, rabbits, and dogs. AFL-CIO. and the United Rubber Work 1. Background. Vinyl chloride (chloro- The employees of the B. F. Goodrich ers International Union made a joint othene), Chemical Abstracts Service Chemical Company who died from an petition for an emergence temporary Registry No. 75015, is a synthetic chemi giosarcoma of the liver had an average standard for VC (TR 141-148), which cal made by oxychlorination of ethylene exposure of approximately 19 years to was also joined by the Oil, Chemical and or by hydrochlorination of acetylene. It vinyl chloride, at unknown concentra Atomic Workers International Union is the parent compound of a series of tions, and variable exposures to other (TR 37>. At the same hearing, several thermoplastic resin polymers and co volatile chemicals. (TR 93). Some em participants urged, on the other hand, a polymers which are widely used for con ployees of Union Carbide Company ancl regular rulemaking proceeding as the tainers, wrapping tissues, electrical in Goodyear Company are also reported in most suitable for the orderly develop sulation, pipe, conduit and a variety of a post-hearing comment from NIOSH ment of relevant Information tTR 112 other products. Vinyl chloride has been dated March 11, 1974, to have had ex 180). made commercially in this country since posure to vinyl chloride and to have died xiir: i -- m", nns iur an emergency tem I 939 and present production is In excess from angiosarcoma of the liver. Finally, porary standard specified in'detail Cv of seven billion pounds per year. autopsies of four deceased employees re contents of the standard requested. In Vinyl chloride (VC) is a gas at am vealed that liver angiosarcoma tumors substance, the request is to Issue n com bient temperature and pressure and is a were histologically indistinguishable prehensive fully-developed stand''.' chlorinated hydrocarbon which has mod from the angiosarcoma tumors observed based cm the recommendations of the erate liver toxicity. The present standard in Professor Maltoni's experimental ani Standards Advisory Committee on Car sets a ceiling value of 500 parts per mals. It is concluded therefore, that cinogens submitted to the Assistant Sec million (ppm) (29 CFR 1910.93). vinyl chloride is carcinogenic for hu retary of Labor on or about August 2h On January 22, 1974, the Occupational Safety and Health Administration was informed by the National Institute for Occupational Safety and Health <NIOftH) that the B. F. Goodrich Chem ical Company reported that deaths of several of its employees from a rare form of liver cancer may have been occupa tionally related. As a result of this notifi cation, and after consultation with NIOSH 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 both VC and polyvinyl chloride was an nounced on Januarv 30, 1974 (39 PR 3874), and held on February 15, 1974. 2. Carcinogenicity of VC. Information produced at the hearing demonstrated that exposure of laboratory animals (mostly Sprague-Dawley rats) to VC by inhalation at and below the current OSHA standard of 500 ppm induced tumors, including angiosarcomas of the liver. Professor Cesare Maltoni, of the Institute di Oncologia, Bologna, Italy, re ported on a scries 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 43-62). Some of the experiment?; have been con cluded, and others are still ongoing. Tf& experimental results so far reported are that tumors have been observed In groups of animals exposed to VC at con centrations as low as 250 ppm. No tumors have been observed in the group of ani mals exposed to VC at a concentration of 50 ppm. It also appears so far that the total number of tumors, as well as the numbers of angiosarcomas of the liver, decrease as the concentrations of VC arc reduced to 250 ppm. Finally, another experiment by Professor Mal- mans. We therefore conclude that the present standard for VC should be lowered from a coiling of 500 ppm to a ceiling of 50 ppm for the following reasons: (a> In light of the evidence referred to above including the Mai toni experi ments demonstrating that VC is carcino genic in animals at 250 ppm, we conclude that VC must be considered carcino genic in man at the same level; <b) Although Professor Maltoni did not Induce tumors in his experimental animals at an exposure concentration of 50 ppm, these data do not support the concept that occupational exposure of employees to concentrations of 50 ppm throughout their working lifetime would be without detrimental health effects; (c) The question whether safe levels of exposure to carcinogens exist for hu mans and, if so, what such levels would be, is the subject of continuing scientific, deliberation. In the case of VC, Profes sor Malt-oni did not observe tumors in his animals at exposure concentrations of 50 ppm. In addition, Torkelson, Oyen, and Rowe found that exposure to con centrations of 50 ppm of VC failed to in duce tumors in rats, hamsters, rabbits, and dogs. Accordingly, there is insufiv ient evidence at this time to conclude that, VC at concentrations of 50 ppm or below poses a grave danger to humans. 'd> The emergency temporary stand ard adopted represents a substantial re duction in the permissible level of expo sure and, In our practical judgment, is the lowest level that can be complied with immediately; and ;c` This standard will be in effect for a period of no longer than six months, during which time the whole question of possible safe exposure of humans to VC will be reconsidered more fully and In the light of more information, including experiments which are under way at this 1973. The recommendations are far- ranging, and cover special categories of operations signs and labels, medical sur veillance, reporting, etc . including a per mit system for the use of a carcinnv'-ri. We agree that an emergency t. ~mo- rary standard is necessary; we cannot say on the basis of the information developed so far that a comprehensive standard, such as the one requested, is either nec es sary or even desirable. It has teen de cided to promulgate a standard c.ontair ing only those essential provisions which are deemed necessary to provide protec tion to employees from grave de : r" until a regular rulemaking ; rnceedr . u accordance with sections 6 <b> and of the Act can be concluded. The me sons for a decision to establish a ceding value of 50 ppm have already been stated. A decision on other possible, ap propriate provisions is best me '- .-'.'ter consideration of all relevant dria, and views that interested persons in :y sub mit during the proceeding sunn to be initiated. With respect to argument:; :n t-p;>osl- tion to issuance of an emergency tem porary standard, the concern and < Ports of several companies participating id the hearing for tho protection o, tin em ployees are recognized. It may bo that, some employers in some plants have fully complied with the interim ror.fcvs recommended by NIOSH on Janu i y .'o, 1974. There is. however, reaeon 's believe that employees are currently be ng ex posed to VC at concentrations v ' hove 50 ppm. This was asserted - - 1 tfv ; at the healing, and not. seu' : ./ m,. - tioned. Moreover, a, r-mort. dated Mr . '> 1974. of a survey by the .stVf c * T of Standards Development, O. T \ <. several facilities manufacturing V b and polyvinv 1. chloride revealed r,, nce 'Na tions for some job classifies teas as high as 229 ppm. Therefore, a regulation i tonl Is underway involving the exposure time (TR 47, 49, 71-74). considered necessary to provtd homed'. of 300 animals to VC at concentrations of 3. Petitions for an emergency tempo ateiy adequate protection to workers rx- FEDERAL REGISTER, VOl. 39, NO. 67--FRIDAY, APRIL 5, 1974 t VAB.0001205377 IP 1ir t* 't*r * " RULES AND REGULATIONS 1231. posed to VC. Also, the eight-hour; timeweighted average .standard suggested by .several participants at the hearing (see, for instance. Tit 178). bar, been rejected. The March 11)74 report of tho survey re vealed that, several kinds of work or op eration** are of short dural.ion. Ix>adlng or unloading of a tank ear may require approximately If) minutes. The cleaning of a reactor may require approximately h df an hour. An eight-hour, time- weighted average standard would permit exposure to VC at concentrations of 400 ppm for one hour. Such upward excur sions, several times the 50 ppm level, can not be permitted to occur. 4. The standard. The standard set out below contains only the requirements deemed necessary to provide protection before the conclusion of the rulemaking proceeding to toe commenced shortly. Because exposure to VC is hazardous, and because such exposure can occur in the processes of synthesizing or polym Secretary of Labor's Order No. 12-71 (38 FR 8754). 29 CFR Part 1910 is amended by adding thereto a new 5 191.0.93q to read as set forth below. In addition, pur suant to section 4(b) *2) of the Act <84 Stat. 1502; (29 U.8.C. 653)), tho stand ard in the new 8 1910.93q is determined to be more effective than the corre sponding standards now in Subpart B of Part 1910, in Parts 1915, 1916, 1917, 1918. and 1926 of til !o 29. Code of Federal reg ulations, and in Part 50-204 of Title 41 of the Code of Federal Regulations. There fore, these corresponding standards are superseded by the new standard in 8 1910.93q. 1. In 29 CFR Part 1910. 8 1910.93 is amended by deleting from Table 0 -1 the line: "* * * C Vinyl chloride * * * 500 * * 1300". 2. Part 1910 of Title 29 of tho Code of Federal Regulations is amended by adding thereto a new 1910.P3q to read as follows; (4) Employee obseri'ation of monitor ing. Employees working in an area or operation whose ambient air is moni tored, or their representatives, shall be given a reasonable opportunity to obrerv1 tho personnel monitoring required by this section. *5) Recordkeeping. The results of all monihnlng shall be recorded in wntit' The records shall he retained for at lens) 5 years and shall be made available for inspection and copying by representa tives of the Assistant Secretary of I abor ter Occupational Safety and fted'h and the Director of tho National Insti tute for Occupational Safety and He-d* h < NIOSH). <6) Employee access. Each and former employee shall h ie a a e; ' 1 such records of the results o. mom:oring required by this see*'on as will in he ate his own exposure to airborne concentra tions oi vinyl chloride. <7> Employee, notification. Each em- p1 over shall promptly notify irnv em erizing of VC or in the handling of VC polymers or copolymers which contain absorbed VC, this standard applies to all such processes and to the handling, re acting, manufacturing, processing, re leasing, repackaging, or storage of any of these material :. I.he monitoring require ments serve two purposes, to trigger into operation a compliance program and to ( heck the rlFe< tivemv.s of the program Also, engineering controls are favored for compliance, and respirators are Intended to provide protection until such controls can be installed or in cases where such controls arc not feasible Accordingly, by reason oi the foregoing and on the basis of the record of the hearing of February 15. 1974, with ex hibits, the written submissions received before the hearing pursuant to the police of tho hearing, the post-hearing written .submissions by the participants at the hearing, the March 1974 report of a fact finding survey recommendations received from NFOSH, and the other data referred to herein, it is found (1) that. VC at con centrations in excess of 50 ppm Is physi cally harmful and carcinogenic; (2) that exposure to VC at concentrations in ex cess of a concentration of 50 ppm poses a grave danger to employees; (3) that em ployees are presently exposed to VC at concentration:-, in excess of 50 ppm; and <4) that 1 he emergency temporary stand ard set out below is necessary to provide immediate protection to employees from such danger. Pursuant to see'I'm go-p of the Occu lOlO.O.'ltj Vinyl chloride. (a) Scope and application. (1' This section applies to any area or operation in which vinyl chloride (chloroethene), Chemical Abstracts Service Registry Number 75015, is manufactured, reacted, handled, processed, released, repacked, or stored. <21 Tiiis section does not apply to the handling, storage, or other use of vinyl chloride polymers and copolymers in the form of fabricated prod net.s. <b> Permissible exposure. The occupa tional environment shall be controlled so that no employee is exposed to vinyl chloride at a concentration in excess of 50 parts per million (ppm) (127.0 mg cum). <e) Monitoring--(1) Initial monitormg. As soon as possible hut not later than April 22. 1974, every employer of an em ployee working in an area or operation in which vinyl chloride is manufactured, re acted, handled, processed, released, re packed, or stored shall begin monitoring the ambient air of the area to determine whether it contains vinyl chloride in con centrations in excess of 50 ppm. (2) Frequency. Monitoring of a suffi cient number of employees so that a representative sample of exposures to viuv! chloride may he determined shrill be accomplished not less frequently than weekly until all results for three consecu tive weeks are at or below 50 ppm. There after, monitoring shall be conducted not less frequently than monthly so long as the concentrations of vinyl chloride do ployee who has been or is being exposed to vinyl chloride in concentrations in ex cess of 5f) ppm, and shall inform him ot the corrective action being token, I d > Compliance. ' 11 Whenever am' monitoring sample reveals vinyl chloride at a concentration in excess of 59 pprn. or whenever any accident, Mich a: rup ture of equipment or spidage, indtrail the likelihood of a greater then uso,d release of vinyl chloride into the ambien' air. all employees exposed to mi : ;v cent-rations shall be withdrawn to : .- he area end shall not l>e pe*""died 1 r enter the work area unle: . (her i r-*eit her Type C continuous he w r * pro . sure demand air sunphed h-'spit 1 or. or self-contained breathing apparatus. (2) Work which may r. asnn.V 'v be expected to relearn vim < chloride :n con centrations in excess of 59 ngn, such es rep:'- i r. maintenance or clean mg of re actors or other equipment containing vmvl chloride, shall be imromn* ' i,\i on1', by employees wearing Tyj>e O re muf" flow or pressure demand air : nnulin : < pirators or self-contaih' J hre h : : paratus. (3) In env c ase cove "ed by para graphs <d.Ml< or ute'2' of this section, in addition to providing the renun cd respirators, the ermdryer .'hah exe." end analyze the soar o o. the eia * : vc concent rations of vinyl chloride in cudcr to determine feasible engineering rv op erational controls appropri; f'k t< r; m- c the airborne concentration-, to * errmissable level. Such controls -e ' be pational Safety and Health Aet' of 1970, not exceed 50 ppm. If a monitoring sam implemented as quickly cs p rsib1 - a proceeding will commence shortly in ple reveals vinyl chloride in concentra <4) Periodic tests shall bo condo al accordance with sect ion 6(b) of the Act, tions in excess of 50 ppm, w eekly moni- for equipment, leaks and for env.ss'oxs in which the emergency temporary '"ling shall be resumed until all results of vmvl chloride which may result Pum standard wilt serve as a proposed rule, on- throe consecutive weeks are at or be work pi-,1 '-tires. together with other subsidiary rules. Ac. soon as po:, >!>)e a draft environmental impart statcovd will, lie fl'od with the low 5 ) ppm. *3) Method of monitoring. Personnel monitoring shall be accomplished bv col 3 Jr 29 CFR Part 19te revised to road e". Jo'lnv.o 1910 19 j*- President's Council on F.mn oilmen* :d Quality, and copies will be provided to lecting samp'os by suitable devices worn by the employee. The samples .sha'* be K M"J0,|O SjH-- i 1 proxs'ui.H for nir con- t:: :n;im other appropriate Federal agencies for analyzed by gras chromatography or by <7t Asbestos : "'* 1 on IP-IO.PSrx their comments. any other method which is of equivalent hall apply to the cx-mmim every cm Pursuant to sections 0(c) and 8'c) (3 sensitivity. 'J lie* analytical procedure plo. ee to asbestos de " in ever ' cm of tho Williams-Steiger Occupational shall be sensitive to 5 ppm of vinyl chlo meet and place of engdavir. - ' ^o. Med Safety and Her.'.'h Act of 1970 (84 St d ride in air with an accuracy of y-20 per by r 1910 13 f 1C1-) '2 : 19''* H. P-'JG. 1599; (29 I"SO. 655, 657m, and cent for a ten minute air sample. $'1910.15. or 8 If'1'- in heu of on i-i- No. 67 --PI. I federal 1STEA, VOL. 39, NO. 67--FRIDAY, APRIL 5, 1974 VAB.0001205378 n- 12314 fprent standard on exposure to asbestos dust which would otherwise be appli cable by virtue of any of those sections. (b) Vinyl chloride. Section 1910 93q shall apply to the exposure of every em ployee to vinyl chloride in every employ ment and place of employment covered by $ 1910.12, 1910 13. 1910.14. 1910.1ft. or 1910.16, in lieu of any dif ferent standard on exposure to vinyl chloride which would otherwise be ap plicable by virtue of any of those sec tions. Effective date. These amendments shall become effective on April 5, 1974. {Rees. *, 6. and fl, 84 Stat. 1592, 1590. 1599 (29 U.S.C. 053. 655, 657); Secretary of Luhcr'n Order No. 12- -71.30 FR 8754 ) Signed at Washington, DC., this 2d day of April 1974. John Sremun. Assistant Secretary of Laly l FR Doc.74 -7090 Filed 4-4-74:0:45 ainj RULES AND REGULATIONS s. FEDERAL REGISTER, VOL. 39, NO. tr--FRIDAY, APRIL 5, 1974 VAB.0001205379 m