Document np16rNqkp0BEd9j5VxOyR5Mm2

12342 ) RULES AND REGULATIONS Tltk 29--Labor 50 ppm, in order to assess in a more rary standard. In a telegram to the As CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS definitive way whether that level of ex posure produces turnon in animals. Data reported by Torkelaon, Oyen and Rowe (American Industrial Hygiene Associa tion J 22:354-361 (1951)) indicate that exposure to VC at concentrations of 50 sistant Secretary of Labor, received on or about March 14, 1974, the President of the United Rubber Workers Interna tional Union urged the establishment of an emergency temporary standard lor VC. During the hearing of February 15, EmsfgsnqrTsmporary Standard tor ppm failed to induce turnon in rate, 1974, the Industrial Union Department, Exposure to Vinyl Chloride hamsters, rabbits, and dogs. AFL-CIO, and the United Rubber Work 1. Background. Vinyl chloride (chlaro- The employees of the B. F. Goodrich ers International Union made a Joint ethene), Chemical Abstracts Service Registry No. 75015, it a synthetic chemi cal made by oxychlorination of ethylene or by hydrocbtorinatiun of acetylene. It is the parent compound of a aeries of thermoplaetlc resin polymers and co polymers which are widely used for con tainers, wrapping tissues, electrical In sulation, pipe, conduit and a variety of other products. Vinyl chloride has been made commercially in this country since Chemical Company who died from an giosarcoma of the liver bad an average exposure of approximately 19 yean to vinyl chloride, at unknown concentra tions, and variable exposures to other volatile chemicals. (TR 93). Borne em ployees of Union Carbide Company and Goodyear Company are also reported in a post-bearing comment from NIOSH dated March 11. 1974, to have had ex posure to vinyl chloride and to have died petition for an emergency temporary standard for VC (TR 141-145), which was also joined by the OIL Chemical and Atomic Workers International Union (TR 37). At the same hearing, several participants urged, on the other hand a regular rulemaking proceeding as the most suitable for the orderly develop ment of relevant Information (TR 112, 180). The petitions for an emergency tem 1939 and present production is in excess of seven billion pounds per year. Vinyl chloride (VC) is a gas at am bient temperature ami pressure and la a chlorinated hydrocarbon which has mod erate liver toxicity. The present standard sets a ceiling value of 500 parte per tniuitm (ppm) (29 CFB 1910.93). On January 22.1974, the Occupational Safety and Health Administration was informed by the National Institute for Occupational Safety and Health (NIOSH) that the B. P. Goodrich Chem ical Company reported that deaths of several of its employees from a rare form of liver earner 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 haaards involved with the manufacture and use of both VC and polyvinyl chloride was an nounced on January 30, 1974 (39 VR 3974), and hold on February 15,1974. 2. Carcinogenicity of VC. Information produced at the bearing demonstrated that exposure of laboratory animals fran angiosarcoma of the lira. Finally, autopsies of four deceased employees re vealed that liver angiosarcoma tumora were histologically indistinguishable from the angiosarcoma turnon observed in'Professor Maltonl's experimental ani mals. It is concluded therefore, that vinyl chloride la carcinogenic for hu- We therefore conclude that the present standard tor VC should be lowered from a ceiling of 600 ppm to a celling of 50 ppm for the following reasons: (a) Xu light of the evidenoe referred to above Ineluding the Maltonl 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 seme level; (b) Although Frofeseor Maltonl did not Induce turnon In bis experimental animals at an exposure concentration of 50 ppm, those data do not support the concept that occupational exposure of employees to concentrations of 60 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 porary standard specified in detail the contents of the standard requested, in substance, the request is to issue a com prehensive fully-developed standard based on the recommendations of the Standards Advisory Committee on Car cinogens submitted to the Assistant Sec retary of Labor on or about August 27, 1973. The recommendations are fax ranging, and cover special categories of operations, signs and labels, medical sur veillance, reporting, etc., including a per mit system for.the me of a carcinogen. We agree that an emergency tempo 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 neces sary or even desirable. It has been de cided to promulgate a standard contain ing only those essential provisions which are deemed necessary to provide protec tion to employees from grave danger until a regular rulemaking proceeding in accordance with sections 6 (b) and (c> of the Act can be concluded. The rea sons for a decision to establish a celling value of 50 ppm have elieady been stated. A decision mi other possible, ap propriate provisions is best made after (mostly Sprague-Dawley rats) to VC by inhalation at end below the current OSHA standard of 500 ppm induced tumors. Including angiosarcomas of the liver. Professor Cesare Maltonl, of the Institute di Oncologta, Bologna, Italy, re ported on a series of experiments on the effect of exposure of rate, mice, and be, is the subject of continuing scientific deliberation. In the case of VC, Profes sor Maltonl did not observe tumora in his animals at exposure concentrations of 50 ppm. to addition, Torkelaon, Oyen, and Rowe found that exposure to con centrations of SO ppm of VC tailed to In duce tumors in rats, hamsters, rabbits, consideration of all relevant data and views that interested persons may sub mit during the proceeding soon to be initiated. With respect to arguments in opposi tion to issuance of an emergency tem porary standard, the concern and efforts of several companies participating at the hamsters to VC at concentrations of 10.000; 6,000; 2,500; 500; 250; and 50 ppm for varying periods of time (TR 43-53). Some of the experiments have been con cluded, and others are still ongoing. The experimental results so far reported are and dogs. Accordingly, there is Insuf ficient evidence at this time to conclude that VC at concentrations of 60 ppm or below poses a grave danger to humans. (d) The emergency temporary stand ard adopted represents a substantial re hearing for the protection of their em ployees are recognised. It may also be that some employers in some plants have fully complied with the interim controls recommended by NIOSH on January F0. 1974. There is, however, reason to believe that tumors have been observed in groups of animals exposed to VC at con duction in the permissible level of expo sure and, In our practical judgment, is that employees are currently being ex posed to VC at concentrations well above 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 are reduced to 250 ppm. Finally, the lowest level that can be complied with immediately; and <e) 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 50 ppm. This was asserted revera! times at the hearing, and not seriously ques tioned. Moreover, a report, dated March 1974, of a survey by the staff of the 0.7i-n of Standards Development, OKHA, of several facilities manufacturing VC and polyvinyl chloride revealed concentra tions for some Job classifications as high another experiment by Professor Mal experiments which are under way at this as 229 ppm. Therefore, a regulation is tonl Is underway involving the exposure time (TR 47,49.71-74). considered necessary to provide immedi of 300 animals to VC at concentrations of 3. Petitions for on emergency tempo ately. adequate protection to workers ex- ItOEItAL REGISTER. VOL. 39, NO. 67--FRIDAY, AFRIL S, 1974 DTH 000016608 1 RULES AND RELATIONS 12343 posed to VC. Also, the eight-hour, timeweighted avenge standard suggested hr several participants at the hearing (see, for instance, TR178), has been rejected. The March 1974 report of the survey re vealed that several kinds of work or op erations are ot short duration. Loading or at a tank ear may require approximately IS minutes. Hie cleaning of a reactor may require approximately half 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 be commenced shortly. Because exposure to VC is hazardous, and because such exposure can occur in the processes of synthesising or polym 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 materials. The monitoring require ments serve taro purposes, to trigger into operation a compliance program and to check the effectiveness 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 are not feasible. Accordingly, by reason of 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 notice of the hearing, the post-hearing written submissions by the participants at the hearing, the March 1974 report of a fact finding survey recommendations received from NIOSH, 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 concentrations in excess of 50 ppm; and (4) that the emergency temporary stand ard set out below is necessary to provide immediate protection to employees from such danger. Pursuant to section 6(c) of the Occu pational Safety and Health Act of 1970, a proceeding will commence shortly in accordance with section 6(b) of the Act, in which the emergency temporary standard will serve as a proposed rule, together with other subsidiary rules. As soon as possible a draft environmental impact statement will be filed with the President's Council on Environmental Quality, and copies will be provided to other appropriate Federal agencies for their comments. Pursuant to sections 6(c) and 8(c) (3) of the Williams-Steiger Occupational Safety and Health Act of 1970 (84 Stat. 1596, 1599; (29 U.S.C. 655, 657)), and Secretary of Labor's Order No. 12-71 (36 PR 8754), 29 CFR Part 1910 Is amended by adding thereto a new 11910.93q to read as eat forth below. In addition, pur suant to section 4(b) (2) of the Act (84 Stat. 1592; (28 US.C. 653)), the stand ard in the new i 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 title 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 11910.93q. 1. In 29 CFR Part 1910, f 1910.93 Is amended by deleting from Table G-l the line; - c Vinyl chloride 500 1300". 2. Part 1910 of Title 29 of the Code of Federal Regulations is amended by adding thereto a new { 1910S3q to read as follows: 8 1910.93q 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 75010, is manufactured, reacted, handled, proceesed, released, repacked, or stored. -- ' (2) This section does not apply to the handling, storage, or other use of vinyl chloride polymers and copolymers in the form of fabricated products. (b) Permissible exposure. The occupa tional environment shall be controlled so that no employee is exposed to vinyl chloride at a concentration in excess at SO parts per million (ppm) (127.0 mg/CUm): x ~i ~ ...'V. J (c> Monitoring--(1) initial monitor ing. As soon ms possible but not later than April 22,1074, every employer of an em ployee working in an area m-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 vinyl chloride may be determined shall 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 he conducted not less frequently than monthly so long as the concentrations of vinyl chloride do not exceed 50 ppm. If a monitoring sam ple reveals vinyl chloride in concentra tions in excess of 50 ppm, weekly moni toring shall be resumed until all results for three consecutive weeks are at or be low 50 ppm. (3) Method of monitoring. Personnel monitoring shall be accomplished by col lecting samples by suitable devices worn by the employee. The samples shall be analyzed by gas chromatography or by any other method which is of equivalent sensitivity. The analytical procedure shall be sensitive to 5 ppm of vinyl chlo ride in air with an accuracy of 20 per cent for a ten minute air sample. (4) Employee observation of monitor ing. Employees working in an area or operation whose ambient air is moni tored, or their representatives, riiaii be given a reasonable opportunity to observe the personnel monitoring required by this section. (5) Recordkeeping. The results of all monitoring shall be recorded in writing. The records shall be retained for at least 5 yean and Shall be made available for inspection and copying by representa tives of the Assistant Secretary of Labor for Occupational Safety and Health and the Director of the National Insti tute for Occupational Safety and Health (NIOSH). (0) Employee access. Each employee and former employee shall have access to such records of the results of monitoring required by this section as will indicate his own exposure to airborne concentra tions of vinyl chloride. (7) Employee notification. Each em ployer shall promptly notify- any em ployee who has been or is being exposed to vinyl chloride in concentrations in ex cess of 50 ppm, and shall Inform him of the corrective action being taken. (d) Compliance. (1) Whenever any monitoring cample reveals vinyl chloride at a concentration In excess of 50 ppm, or whenever any accident, such as rup ture of equipment or spillage. Indicates ' the likelihood of a greater than usual release of vinyl chloride Into the ambient air, all employees exposed to such con- centrations shall be withdrawn to a safe , area and shall not be permitted to re-.. enter the work area unless they wear - -either Type C continuous flow or pres-3 sure demand air supplied respirators or,, self-contained breathing apparatus.' -3. /1 (2) Work which may reasonably be expected to release vinyl chloride in con centrations in excess of 50 ppm, such as repair, maintenance or churning of re actors or other equipment containing vinyl chloride, shall be accomplished only by employees wearing Type C continuous,- flow or pressure demand air supplied res pirators or self-contained breathing ap paratus. (3) In any case covered by para-: graphs (d> (1) or (d) (2) of this section, in addition to providing the required respirators, the employer shall examine and analyze the source of the excessive concentrations of vinyl chloride in order to determine feasible engineering or op erational controls appropriate to reduce the airborne concentrations to the permissable level. Such controls shall be implemented as quickly as possible. (4) Periodic teste shall be conducted for equipment leaks and for emissions of vinyl chloride which may result from work practices. 3. In 29 CFR Part 1910. 11910.19 is revised to read as follows: 1910.19 Specie! provisions for air con taminants. (a) Asbestos dust. Section 1910.93a shall apply to the exposure cf every em ployee to asbestos dust In every employ ment and place of employment covered by 1 1910.12, t 1010.13, 1910 14, S 1910.15, or { 1910.16, in lieu of any dif- Ho. 67--Pt. I- FEDERAl REGISTER, VOL. 39, NO. 67--FRIDAY, APRIL S, 1974 DTH 000016609 12344 ferent standard an 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 11810.12, 11910.13, t 1910.14, 11010.16, or 11910.16, In lieu of any dif ferent standard an 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. (Sec*. 4, e. end B, 84 Stat. 1892, ISM, 1599 (29 un.c. ess, ess, M7); Secretary of Labor's Order No. 12-71.80 nt 8784.) Signed at Washington, DC., this 2d day of April 1974. JOSH SlXNDEB, Assistant Secretary of Labor. ira Doc.74-7890 Hied 4-4-74:8:48 am] RULES A, . REGULATIONS ! KDERAL IE6ISTER, VOL. 39, NO. 67--FRIDAY, APRIL S, 1974 dTH 000016610