Document bawo4byq0n1rL92OeMKQL6eG1

12312 ruies 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 AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS definitive way whether that level of ex posure produces tumors In animals. Data reported by Torkelson. Oyen and Rowe (American Industrial Hygiene Associa tion J 22:354-361 (1961)) 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 for VC. During the hearing of February 15 Emeraency Temporary Standard for ppm failed to induce tumors in rats, 1974, the Industrial Union Department! Exposure to Vinyl Chloride hamsters, rabbits, snd dogs. AFL-CIO. and the United Rubber Work 1. Background. Vinyl chloride (chloroethene). Chemical Abstracts Service Registry No. 75015, Is a synthetic chemi cal made by oxychlorination of ethylene or by hydrochlorination of acetylene. It is the parent compound of a series of thermoplastic 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 1939 and present production Is In excess of seven billion pounds per year. Vinyl chloride (VC) Is a gas at am bient temperature and pressure and is a chlorinated hydrocarbon which has mod erate liver toxicity. The present standard sets a celling value of 500 parts per million (ppm) (29 CFR 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. 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 January 30, 1974 (39 PR 3874), and held on February 15,1974. 2, Carcinogenicity ot 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 ti\e Institute di Oneologia, Bologna, Italy, re ported 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 con cluded, and others are still ongoing. The 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, The employees of the B. P. Goodrich Chemical Company who died from an giosarcoma of the liver had an average exposure of approximately 19 years to vinyl chloride, at unknown concentra tions, and variable exposures to other volatile chemicals. (TR 93). Some em ployees of Union Carbide Company and Goodyear Company are also reported in a post-hearing comment from NIOSH dated March 11. 1974, to have had ex posure to vinyl chlbrldc and to have died from angiosarcoma of the liver. Finally, autopsies of four deceased employees re vealed that liver angiosarcoma tumors were histologically indistinguishable from the angiosarcoma tumors observed in Professor Maltonl's experimental ani mals, It Is concluded therefore, that vinyl chloride Is carcinogenic for hu mans. We therefore conclude that the present standard for VC should be lowered from a ceiling of 500 ppm to a ceiling of 50 ppm for the following reasons: (a) In light of the evidence referred to above including the Maltoni 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 Maltoni did not observe tumors In his animals at exposure concentrations of 50 ppm. In addition, Torkelson, Oycn, 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 Insuf ficient evidence at this time to conclude that VC at concentrations of 50 ppm or below poses a grave dancer 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 (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 to the light of more information, including ers International Union made a joint petition for an emergency temporary standard for VC (TR 141-148). which was also joined by the Oil. Chemical antf 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 tor the orderly develop ment of relevant Information (TR 112, 180). The petitions for an emergency tem porary standard specified to 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 farranging, and cover special categories of operations, signs and labels, medical sur veillance. reporting, etc.?ineluding a per mit system for the use 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 already been stated. A decision on other possible, ap propriate provisions is best made after 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 hearing for the protection of their em ployees are recognized. It may also be that some employers to some plants have fully compiled with the Interim controls recommended by NIOSH on January 30, 1974. There Is, however, reason to believe that employees are currently being ex posed to VC at concentrations well above, 50 ppm. This was asserted several times' at the hearing, and not seriously ques tioned. Moreover, a report, dated March 1974, of a survey by the staff of the Office of Standards Development, OSHA, 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 an emergency tempo ately, adequate protection to workers cx- FtDEtAL REGISTER, VOL 3, NO. 67--FRIDAY, AM11 3, 1V74 GENC 014872 RULES AND REGULATIONS 12343 posed to VC. Also, the eight-hour, time- Secretary of Labor's Order No. 12-71 (36 (4) Employee observation of monitor weighted average standard suggested by FR 8754). 29 CFR Port 1910 is amended ing, Employees working in an area or several participants at the hearing (see. by adding thereto a new 119l0.93q to opeRation whose ambient air is moni for instance, TR 178), ha* been rejected. read as set forth below. In addition, pur tored, or their representatives, shall be The March 1974 report of the survey re suant to section 4(b) (2) of the Act (84 given a reasonable opportunity to observe vealed that several kinds of work or op Stat. 1592; (29 U.S.C. 653)). the stand the personnel monitoring required by erations are of short duration. Loading ard in the hew 3 i9l0.93q i. determined this section. or unloading of a tank car may require to be more effective than the corre (5) Recordkeeping. The results of all approximately 15 minutes. The cleaning sponding standards now in Subpart B of monitoring shall be recorded in writing. of a reactor may require approximately Par*. 1910. in Parts 1915. 1916. 1917,1918. The records shall be retained for at least' half an hour. An eight-hour, time- and 1926 of title 29, Code of Federal Reg 5 years and shall be made available for weighted average standard would permit ulations. and in Part 50-304 of Title 41 of inspection and copying by representa exposure to VC at concentrations of 400 the Code of Federal Regulations. There tives of the Assistant Secretary of Labor ppm for one hour. Such upward excur fore. these corresponding standards are for Occupational Safety and Health sions, several times the 50 ppm level, can superseded by the new standard in and the Director of the National Insti not be permitted to occur. 1 1910 93q. 4. The standard. The standnrd set out 1. In 29 CFR Part 1910, 3 1910.93 is tute for Occupational Safety and Health (NIOSH). .below contains only the requirements amended by deleting from Table 0-1 the (6) Employee access. Each employee deemed necessary to provide protection line:........... .... Vinyl chloride * * 500 and former employee shall have access to before the conclusion of the rulemaking proceeding to be commenced shortly. Because exposure to VC is hazardous, and because such exposure can occur in 1300". 2. Part 1910 of Title 29 of the- Code of Federal Regulations Is amended by adding thereto a new 3 1910.93q to read such records of the results of monitoring required by this section as will indicate his own exposure to airborne concentra tions of vinyl chloride. the processes of synthesizing or polym erizing of VC dr 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 two 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 tire 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 NTOSH, 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 wnich 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. as follows: 19I0.93q . 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 75015, is manufactured, reacted, handled, processed, 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 cliloride at a concentration in excess of 50 parts per million (ppm) (127.0 mg/cum). (c) Monitoring--(1) Initial monitor ing. As soon os possible but 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 vinyl chloride may be determined shall be accomplished not less frequently than weekly mitil all results for three consecu tive w.eeks ore 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 not exceed 50 ppm. If a monitoring sam ple reveals vinyl cliloride 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 (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 sample 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 tlie work area unless they wear either Type C continuous flow or pres sure demand air supplied respirators or self-contained breathing apparatus. (2) Work which may reasonably be expected to release vinyl chloride in con centrations in excess of 50 ppm, such as repair, maintenance or cleaning 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 per missible lev?'. Such controls shall be implemented as ouickly os passible. (4) Periodic tests 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 .Special provision* for sir con- , tammnfit** (a) Asbestos dust. Section 1910.93a' shall apply to the exposure of every em- Pursuant to sections 6(c) and 8(c) (3) sensitivity. The analytical procedure ployee to asbestos dust in every employ of the Wllllams-Steiger Occupational shall be sensitive to 5 ppm of vinyl chlo ment and place of employment covered Safety and Health Act of 1970 (84 Stat. ride in air with an accuracy Of 20 per by 3 1919,12. 3 1910.13, f 1910.14, 1596, 1599; (29 UjS.C. 655, 657)), and cent for a ten minute air sample. 3 1910.15, or 3 1910.16, in lieu of any dlf- No. 87--Pt. I- FCDBtAl lECISTE*, VOL. 39,. NO. 47--WIOAY, AMU 3, 1974 12344 ferent standard on exposure to asbestos dust which would otherwise be appli cable by virtue of any of those sections. (b) Vinyl chloride. Section 1910.930 shall apply to the exposure of every em ployee to vinyl chloride In every employ ment and place of employment covered by } 1910.13. 11910.13, i 1910.14, i 1910.13, or i 1910.18, la lieu of any dif ferent standard on exposure to vinyl chloride which would otherwise be ap plicable by virtue ol any of those sec tions. Effective date. These amendments shall become effective on April 5, 1974. (Sees. 4, e, and 8, M Stat. 1893,1898,1899 (39' Ui?.C. 063, 066, 667); Secretary of Labor's Order No. 10-71.30 FR 07W,) Signed at Washington, DC, this 2d day of April 1974. John Sitsitt, Assistant Secretary of Labor, (TTt Doc.74-7890 Plied 4-4-74,8:48 am] kULES AND REGULATIONS r 6ENC 014374