Document v15axMezVYMYJL2kkxqjMVVdZ

49 were engaged in operation* outside the actual resin production. The productivity of tfrfeae workers has probably increased since , ',<*; , '1 'V ',v 1969 in view of some significant technological changes such as the introduction of the bulk polymerization process, but, on balance, the total number of workers has probably increased beyond 5,000, although less than 10,000. Some of the job classifications of workers involved in resin production, with potential exposure to VC are shown in Table 4. No evaluation of the total industry exposure to vinyl chloride can be made at present, because no estimates of the personnel distribution in these categories are available for the entire industry, and because exposure varies according to job category. The information available does tend to indicate that exposure to VC is greater in resin producing plants than in those synthesizing the monomer. The areas of greatest exposure in a PVC plant are judged to be the following: Unloading of Incoming vinyl chloride; Reactor cleaning; Entry of vinyl chloride containing vessels for maintenance and repair work; Entry of PVC storage silos; Shipping or packaging of PVC; and 0 Leaks of vinyl chloride in the process area. *v Levels of VC exposure in these plants have been decreasing rapidly since January, 1974. For the entire Industry, the. average TWA is probably well below 25 ppm. Exposures differ i BOR 004732 Table 4 Job Categories of Worker* Production of PVC Resina Begging end shipping operetor Catalyst makeup man Dryer operator General laborer, custodial Laboratory technician Maintenance personnel Monomer maintenance personnel Monomer operator Monomer recovery operator Monomer supervisor Polymer supervisor Reactor cleaner Reactor operator Slurry blender Utilities operator Warehouse personnel 50 `S BOR 004733 ! 51 for each job category, but, from the available data. It appears that reactor cleaners are likely -to suffer the greatest exposure. Operators of the polymerization process equipment, those Involved In unloading or transferring the monomer, and maintenance personnel, respectively, have successively lower exposures to VC. Other personnel are likely to he exposed to considerably lower levels. Reactor cleaning poses a special hazard. During the reaction process, the polymer, with entrapped monomer, builds up on the surface of the reactor, so that periodic cleaning Is usually required. In the past, most of this cleaning was performed by hand using a scraper and chisel. Air analyses have shown that VC concentrations in the reactor prior to ventilation reach 3,000 ppm. After ventilation has been completed and the worker begins the scraping, concentrations between 50 and 100 ppm may easily be released. Air analyses have shown concentrations of 600 to 1,000 ppm of VC close to the hand. Since these studies were completed, industry has moved to greater use of water-jet or organic-solvent cleaning. Industry has also Instituted monitoring procedures of reactor interiors prior to worker entry. Another exposure problem concerning reactor cleaning has been that the air left in the reactor disperses into workroom air, thus producing a major source of vinyl chloride exposure. Substantial efforts are currently underway to recover all unreact d monomer prior to opening the vessel, but the low levels BOR 004734 52 Involved pose a significant technological difficulty. 3. Compounding of PVC Resins with Addltives^-*^*^*^ In most applications, PVC Is used with one or more additives to order to process and convert the compound into its final products. The additives used depend on the initial form of the resin, the type of processing to be used, and the desired application. Resins are classified either as general purpose (made by any of the techniques described In the previous section) or as dispersion (made primarily by emulsion polymerization). After the addition of a plasticizer, the general purpose resins can be further categorized into plasticized resins and unplastlclzed (l.e. rigid) resins. The dispersion resins, or latexes, may be plasticized for ultimate use as plastlsols or organosols, or they may be chlorinated for processing similar to that performed on the general purpose resins. To these basic resins, additives are compounded according to particular requirements. These additives are usually categorized as follows: Plasticizers. to Increase resin flexibility, softness, and elongation,and In some cases, to extend the basic resin; o Heat stabilizers, to prevent discoloration during the processing of resin compounds; o Fillers, to reduce costs, but sometimes to produce opacity, specific electrical properties, resistance >. BOR 004735 53 to ultraviolet light, resistance to blocking, improved dryblending characteristics, and other properties; o Pigments and dyes, to color FVC resin compounds; o Processing aids, .to facilitate the achievement of certain processing objectives, such as increased processing rates, lower processing temperatures, improved fusion, and reduced surface gloss; o Impact modifiers to protect rigid resins against brittle fracture; o Lubricants, to reduce friction of melts with the surfaces of processing machinery and molds; o Light stabilizers, to prevent FVC degradation from continuous exposure to sunlight; 0 fungicides, to inhibit the vulnerability of compounded PVC to attack by microorganisms; o flams retardants, to preserve the nonflammability of PVC cotg>romlsed by the use of flaomtable plasticizers; o Antistatic agents, to Improve electrical conductivity; o Antioxidants, to provide protection in high-temperature applications; and o Foaming agents, to Influence cell structure for resins expanded into foams. The compounding of these additives with PVC resins may occur in a plant producing the basic resin, in a plant designed for Che purpose of compounding alone, or in a plant whichNalso processes the compounded resins. Trade publications identify BOR 004736 54 approximately 200 companies supplying chlorinated, plasticized, and rigid PVC or copolymer resins. The mechanism of the compounding stage ensures that the additives are fully dispersed In the PVC resins to yield a homogeneous material suitable for further processing. The resultant compounds may be In powder or granular form. The latter form Is obtained by heating the conpound into granules or pellets. These are then used aa feedstock for subsequent extrusion and molding processes. The powder form can be fed directly Into fabrication equipment where the PVC resin need be heated only once, thus requiring fewer additives. (1) Process Descriptions A vide variety of compounding equipment Is currently available, most of which uses the resin and the various additives In dry form. Sometimes, the resin Is premixed with several additives before it is used In further processing with other additives. The order In which specific confounding equipment Is used depends on the specifications the PVC must meet. Two-Roll Mill - The material in the form of a powder blend Is fed into a mill consisting of two rolls separated by a small gap. The mill kneads the material for about 10 minutes at a temperature of 150-160C and strips It off as a continuous band. This strip of material 1b then granulated Into small cubes suitable for use in an extruder. , BOR 004737 55 WjnhMry Mt>r - The mixer consists of * jacketed mlxint chamber fitted with blades rotating in oppoalte directions. It mixes batcha of tha material under preaaure and heat to produce a fuead and kneaded mixture. The mixture then la dlaeharged in a doughlike mass which la converted Into aheet form for granulation. A two-roll mill la utilized for this purpoae. The use of Banbury mixers can lead to significant varlatlona between batches. This Inconsistency is tampered in some cases by the use of automatic weighing and feeding systems for the Injection of the various mixing materials. Continuous Mixers - This type of mixing is designed to enhance the consistency between batches by providing a continuous feed operation; however, this process requires great care to ensure tha homogeneity of tha resultant mixture. The machines used are basically single or twin-screw extruders, modified to optimize the handling of the materiel. The compound may be heated, fed directly to calenders, extruded through a die plate for granulation, or axtrudad through a die with a dle-face cutter for granulation. Multiscrew Cospounders - A twin-screw extruder, specially adapted for the purpose. Is also suitable for PVC compounding. The primary advantage this equipment offers,as opposed to the extruders described above,is that its screw sections and kneading discs can be changed to meet the specific requirements of the material being compounded. BOR 004738 56 Bleh-Bnaea - Equipment featuring Injection molding end extrusion has also been modified to accept FVC powder blends* To ensure satisfactory processing, such blends are combined in a high-speed mixer by friction-generated heat. When this type of equipment is used, the production of the proper blends must be performed with great care. Wat Granulation - In this process, the FVC is taken directly from the polymarlser while still in an aqueous dispersion. The additives are Introduced into the granulating vessel along with a plasticiser that had previously been mixed with some of the stabiliser and lubricants. The compounded resin particles ere then rapidly plasticised, producing s substance In the form of granules which are easily separated from the suspension. This process is limited to polymer manufacture, since it is not economically feasible to redlsperse the polymer once it has been dried out. Mixing of Plaetisols - FVC pastes can be produced using paddle-type mixers that can be operated under a vacuum, such as the vertical paddle mixer, the vertical planetary mixer, or the horizontal Z-blade mixer. The FVC resin is introduced into the mixer along with sufficient plasticiser to form a paste. Other Ingredients ere then incorporated slowly and at low temperatures until a smooth homogeneous paste Is obtained. BOR 004739 APPENDIX A EMERGENCY TEMPORARY STANDARD ON VINYL CHLORIDE BOR 004740 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 1910.93q 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, 11910.14. f 1910.15, or { 1910.10, 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. (Secs. 4. S. and 8, 84 Stat. 1893, 1598,1899 (29 TT.C. 663, 886, 687); Secretary of Labor's Order No. 13-71,36 FR 8754.) Signed at Washington, DC,, this 2d day of April 1974. John Stindir, Assistant Secretary of Labor. [KR Doc.74-7890 Piled 4-4-74:8:45 am] RULES AND RE ULATJONS 12U2 RULES AND REGULATIONS Tttte 29--Labor CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Emergency Temporary Standard for Exposure to Vinyl Chloride 1. Background. Vinyl chloride (chloroethene), Chemical Abstracts Service Registry No. 75015, Is a synthetic chemi cal made by oxychlorlnation 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 FR 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 Instituto di Oncologia, 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, another experiment by Professor Mal toni Is underway involving the exposure of 300 animals to VC at concentrations of 50 ppm, to order to m* to a more definitive way whether that level of ex posure produces tumors to animals. Data reported by Torkelson. Oyen and Rowe (American Industrial Hygiene Associa tion J 32:354-361 (1961)) Indicate that exposure to VC at concentrations of 50 ppm failed to Induce tumors to rats, hamsters, rabbits, end dogs. The employees of the B. F. 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 Maltoni'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 lrom 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, Oyen, and Rowe found that exposure to con centrations of 50 ppm of VC failed to in duce tumors in Tats, hamsters, rabbits, and dogs. Accordingly, there Is insuf ficient evidence at this time to conclude that VC at concentrations of 50 ppm or below pos*s 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, to our practical judgment, is the lowest level that can be complied with immediately; and (e) This standard will be to 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 time (TR 47, 49, 71-74), 3. Petitions for an emergency tempo- rare standard. In a telegram to the As sistant Secretary of Labor, received on or about March 14, 1074, the President of the United Rubber Workers Interna tional Union urged the establishment of an emergency temporary standard tor VC. During the hearing of February 15, 1974, the Industrial Union Department. AFL-CIO. and the United Rubber Work 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 and Atomic Workers International Union (TR 37). At the same hearing, several participants urged, on tire 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 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 arc farranging, and cover special categories of operations, signs and labels, medical sur veillance. reporting, etc.. Including 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 tor a decision to establish a ceiling 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 complied 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 os high as 220 ppm. Therefore, a regulation is considered necessary to provide, immedi ately, adequate protection to workers cx- FCDttAL MGISTES, VOL 39, NO. 67--WtDAY, ATtll 5, 1974 BOR 004742 RULES AND REGULATIONS 12343 posed to VC. Also, the eight-hour, timeweighted average standard suggested by several participants at the hearInc (see, for Instance, TR 178). has been rejected. The March 1974 report of the survey re vealed that several kinds of work or op erations are of short duration. Loading or unloading of a tank car may require approximately 19 minutes. The cleaning of a reactor may require approximately half an hour. An eight-hour, timeweighted 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 synthesizing 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 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 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 factfinding survey recommendations received from NiOSM, 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 6fc) of the Occu pational Safety and Health Act of 1970, a proceeding will commence shortly in accordance with section 8(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. Pursuant to sections 6(c) and 8(c) (3) of the Willlams-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. 13-71 (36 PR 6754), 29 CFR Part 1910 Is amended by adding thereto a new f 19i0,93q to read as set forth below. In addition, pur suant to section 4(b) (3) of the Act (84 Stat. 1592; (29 U.S.C. 653)). the stand ard In the new f 1910.93q Is determined to be more effective than the corre sponding standards now in Subpart B of Part mo. In Parts 1915.1916. 1917,1915, 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 3 1910.93Q. 1. In 29 CFR Part 1910. ! 1910.93 Is amended by deleting from Table 0-1 the line:............... Vinyl chloride * * * 500 * * 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 as follows: 1910.93q . Vinyl chloride. (a) Scope ami 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 chloride 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 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 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 throe consecutive weeks are at or be low 50 ppm. (3) Method 0/ 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) tmployee observation of monitor ing. Employees working in an area or operation whose ambient air is moni tored, or tbclr representatives, shall l>& given a reasonable opportunity to obscrvJ the personnel monitoring required this section. (5) Recordkeeping. The results of all monitoring shall be recorded in writing. The records shall be retained for at least 5 years and shall be made available for Inspection and copying by representa tives of the Assistant Secretary of Labor lor Occupational Safety and Health and the Director of the National Insti tute for Occupational Safety and Health (NIOSH). (6) 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 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 the work area unless they wear either Type C continuous flow or pres sure demand air supplied respirators od self-contained breathing apparatus. T| (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 oovered 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 auickly as possible. (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* 3 1910.19 Is revised to read as follows: 1910.19 Speciul provisions for air con- . taminoms. (a) Asbestos dust. Section 1910.93a shall apply to the exposure of every em ployee to asbestos dust in every employ ment and place of employment covered by 3 1910.12. 31910.13, 3 1910.14, 3 1910.15, or 3 1910.16, In lieu of any dlf No. 87--Pt. I- EEDCRAl REGISTER, VOL 39, N . 67--FRIDAY, APRIL S, 1974 BOR 004743 APPENDIX B PROPOSED STANDARD ON VINYL CHLORIDE BOR 004744 ttttt HOPOSID *UU* DEPARTMENT OF UtOft 43-63). some of the' experiments have 4. Additional information. On April 16, been occcluded. and others are' still on 1074, information and data were pre ' ^ Occupational Safety and Haaltti going. The experimental results reported sented to representatives of OSHA. Administration were that turnon have been observed m NIOSH and the EPA by the Industrial 5 [ 29CFR Part 191S ] ~ (Dock** OSH-84) . groups of animals exposed to VC at con Bio-Twt Laboratories. Northbrook. Illi centrations as low as 250 ppm. No tumors nois, concerning results of ex were observed in the group of animals posure studies with VC, sponsored by the VINYL CHLORIDE Popo--d Standard exposed to VC at a concentration of 60 Manufacturing Chemists Association ppm. It also appears that the total num- ' (MCA), awnnggh only preliminary m bar of tumors, as well as the numbers nature, these results revealed that 3 out 1. Background, vinyl chloride (chloro- of angiosarcomas of the liver, decreased of 200 mice exposed to VC concentrations ethene) Chemical Abstracts Service as the concentrations of VC were reduced at 60 ppm for 7 hours a day, five days a Registry No. 76015, Is t synthetic chemi to 250 ppm. Another experiment'by pro week, for approximately 7 months, de cal made by oxychlorl nation of ethylene fessor Maltonl was reported underway. veloped angiosarcomas at the liver. or by hydrochlorination of acetylene. It Involving the exposure of 300 animals 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 60 ppm themoplastic resin polymers and co order to assess m a more definitive way may well constitute a serious health haz polymers which are widely used for con whether that level of exposure produces ard to employees. Also, the question of a tainers, wrapping film, electrical insula tumors in animals. Data reported by safe level of exposure for humans can tion, pipe, conduit, and a variety of other Torkelson, C yen and Rowe (American not be determined at this time, and may products. Vinyl chloride has been made Industrial Hygiene Association J 22: 254- continue as a matter for scientific de commercially in this country since 1S39 361 (1961)) indicate that exposure to liberation for many years. We therefore and present production Is in excess of vc at concentrations of 80 ppm failed to conclude that it Is now necessary to pro seven billion pounds per year. Induce tumors In rats, hamsters, rabbits, pose to change the 60 ppm level estab Vinyl chloride (VC) Is s' gas at am and dogs. lished in the ETS to as low a level as can bient temperature and pressure and la k The employees of the B. F. Goodrich' be detected using methodologies outlined chlorinated hydrocarbon which has moderate liver toxicity.. The previous standard set a celling value of 600 parts per million (ppm) (SO CFR 1910.03, Table Chemical Company who died from angio sarcoma of the liver had an average ex posure of approximately 19 yean to vinyl chloride, at unknown concentrations, In this proposal. (6) The proposed permanent standard. The requirements for a complete stand ard under section 6(b) of the Occupa CM). and variable exposures to other .volatile tional Safety and Health Act of 1970 On January S3,1974, the Occupational Safety and Health Administration (OSHA) was informed by the National Institute for Occupational Safety and Health (NIOfKH) that the B. F., Good rich Chemical Company reported that deaths of several of Its employees from a ran Over cancer (angiosarcoma) may (TR 93). Borne employees of Union Carbide, Firestone Tire and Rub ber, and Goodyear were also reported m post-hearing comments to have had ex posure to vinyl chloride and to have died from angiosarcoma of the liver. Finally, autopsies of four deceased employees re vealed liver angiosarcoma tumors Wan W.toWi(Mlhr am much more comprehensive than the provisions of the ET8 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 of exposure. The proposed standard for employee exposure la set et no detectable level, me determined by a have beat occupationally related. A* a result of this notification and alter con sultation with the National institute for from the angiosarcoma turnon observed nampiing *nd analytical method capable in Professor Maltonl's experimental of detecting vinyl chloride at concentra tions of 1 ppm with an accuracy of 1 Occupational Bafety 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 on possible hazards involved with the manufacture and use of VC was announced on January 30r 1974 (39 FR 3874) and held an February 16,1974. 2. Carcinogenicity of VC. Information produced at this hearing demonstrated that exposure of laboratory animals (mostly Sprague-Dawlty rats) to VC by inhalation at and below the then current OSHA standard of 690 ppm Induced tumors. Including angiosarcomas of the liver. Professor Ceeare Maitool, of the Institute dl Oneok)gla, Bologna, Italy, reported on a aeries of experiments on the effect of exposure erf rats, mice, and hamsters to VC at concentrations of 10,000; 0,000; 2,500; 600; 250; and 60 3. The Emergency Temporary Stand ard. On the basis of all information available at that time, and the fact that employees were being exposed at levels around the experimentally observed ef fect level of 260 ppm, an Emergency Temporary Standard (ETS) was promul gated on April 6, 1974 (39-FR 12343) as 39 CFR 1910.930. This standard reduced the level from a celling of 600 ppm to 60 ppm ceiling. It was errnasty recognised that this standard limiting exposures to a 60 ppm level was intended to be a Imi tative, interim standard, to be in effect no longer than six months, during which 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 werb known to be under ppm-50 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 generally available. A method of A ppm sensitivity has been recommended to OSHA by NIOSH. To mlnlmtwi 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, or used, including opera tions with polyvinyl chloride containing detectable levels of vinyl chloride. Access to the areas would be limited to author ized 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 ppm for varying periods of time (TR- way at that time. tion of employee exposures on an in dividual basis. Provision would also be ftOIKAL MOISTS*, V L XV, NO. 93--MIDAT, MAY 10, 1974 BOR 004745 \ 16897 mde to an opportunity to otitm monitoring by employees or their designoted repraetntetlve*. as requiredjy sec tion 8(e) (3) (d the Act. C. Control method*. Where detectable level* of VC ere monitored, two pro gram* would be triggered: an engineer record to an employee's physician on the (5) "Decontamination" means reduc employee's request. Atabhehments con tion of vinyl chloride concentrations to ducting VC operations would ho required lees than detectable levels. to identify themselves to OSHA. and to (8) "Detectable level" means an air-Ato report Incidents (accidents! resulting in borne concentration of vinyl chloridi^^H the release of vinyl chloride. measurable by a sampling and anslytlcal^^ Accordingly, pursuant to sections 8(b). 'method capable of measuring concentra ing and work practice program to reduce 6(c), and 8(e) of the Occupational tions of 1 ppm. with an accuracy of 1 level* below detectability; and while this Safety and Health Act of 1970 (84 Scat. ppm50 percent. is on-going, * respiratory protection pro 1893,1698, W99: 29 UH.C. 858.857), Sec (7) "Director" means the Director. Na gram to employee* to the regulated area. retary of Labor's Order No. 12-71 (38 FR tional Institute for Occupations! Safety Engineering control* and work prac 8754) and 39 CFR Fart 1911. it Is here and Health, or any person directed by tice* ate favored method* of compliance by proposed to amend 29 CFR Fart 1910 him or the Secretary of Health. Educa beeaiiee they tend to avoid contamina by revising | I910.93q as aet forth below. tion. *nd Welfare to act for the Director. tion of the ambient air in the workplace, Written data, views, and arguments (8) "Emergency'' means an unforaeen Aaeordtncly. it ia proposed to require the concerning the proposals may be -matied circumstance or set of circumstances, re totitution of engineering controls and to the Socket Officer, Docket 06H-38, sulting in the release of vinyl chloride of worimractlce method* as soon a* feasi Room 230,1728 M Street. N.W., Occupa Into area* occupied by employees. bly and to require the use ot respirators tional Safety and Health Administra (9) "Exposure" means actual contact pending the institution of such oenttois, tion. Washington. D.C. 20210, poet- with vinyl chloride when unprotected by to supplement such control* where they marked net later than June 10.1074. required personal protective equipment an msudlolent to teduoe conoentrattona Pursuant to 39 CFR I9ii.il <b> and and clothing. of vtol chloride below the detectable (e>, interested persons may file objec (10) "Fabricated product" means a level* in specified work situations, and tion* to the proposals, requesting an in finished product or part of such product, in caaee of emergency. The proposal for formal hearing with respect thereto, in made of polyvinyl chloride, entirely or In continuous flow and pressure demand accordance with the following condi part, including semifinished products types of respirators is based on the rec- tions: such as film, sheet, Mock, bar, or extru- nnM>etinM of NI06H, which has ob (1) The objections must include the don stock. served 'Tn"*ir through chemical car name and address of the objector; (11) "OSHA Area Director" means the tridge reaplrators at high concentrations (2) The objections must be post- Director for the Occupational Safety end of VC. .marked on or before June 10,1974; Health Administration Area Office hav A requirement would also be estab (3) The objections must specify the ing jurisdiction over the geographic area lished to the provision and use of pro provisions of the proposed rule to which in which the establishment is located. tective clothing for employees in the reg objection is taken, and must state the (12) "Polyvinyl chloride" means poly ulated areas. The protective clothing would Minimi-- skin contact with' VC vapor, and would provide some measure of protection from splash of liquid in the event of a-spill or rupture of equip grounds therefor; (4) Each objection must be separately stated and numbered; and (5) The Objections must be accom panied by a summary of the evidence vinyl chloride homopolyiner or copol ymer before such is converted to a fabrlc&ted nrodUftt. (13) "Protective clothing" mesne clothing protective against vinyl chlo ment. Food, beverages, end like products proposed to be adduced at the requested ride. would be prohibited in the'regulated area. Written operational and emergency plana would be required, along with em ployee training In routine and emergency duties. Specific requirement* would be established for emergency actions and for routln* maintenance and decontami nation operations. Including vessel entry, which are known to present particular hazards. ' The purposes of operational and emer gency plans and training are to apprise employees of the hasdrds to which they may be exposed, of the precautions they must take to avoid such hazards, and to rehearse employees In the procedures they must follow in emergencies. D. Medical turveiOanoe. Comprehen sive requirements for employee medical examinations are proposed, Including necessary tests. Some additional guid ance is included for the convenience of physicians. The proposed requirements have been recommended to 08HA by NICJ8H as reasonably appropriate tp de tect liver dysfunction which may be in dicative `of. or predisposing to, the de velopment of liver angiosarcomas. ' E. Record* and reports. Records of monitonng, medical examinations, and bearing. As revised, f I910.93q would read as follows: f 1910.9Sq Vinyl Chloride. (a) Scope and application. (1) This section applies to any area or operation in which vinyl chloride (chloroethene). Chemical Abetracts Service Registry No. 75015. Is manufactured, reacted, re leased, repackaged, stored, or used,. In cluding areas and operations involving polyvinyl Chloride when detectable levels of vinyl chloride are released. (2) This section does not apply to the handling or use of fabricated products made entirely or in part of polyvinyl chloride. (b) Definitions. (1) "Assistant Secre tary" means the Assistant Secretary of Labor for Occupational Safety end Health, V.8. Department of Labor or his designee. (2) "Authorized employee" means an employee whose duties require him to bo in the regulated area and Who has been specifically assigned by the employer; and any employee who enters such an area as a designated representative ot employees to exercise an opportunity to observe monitoring and msaauriiw of vinyl ciiloride. 04) "Vinyl chloride" meant vinyl chloride monomer.' 05) "Waste resin" means any resii^to or .other reaction product* removed the cleaning of equipment, such as ael* and piping. (c) Reference. Collage of American Pathologists, 230 N. Michigan Ave., Chi cago, Illinois 80801. (4) Regulated areas. (l> A regulated area shall be established where (1) vinyl chloride is manufactured, reacted, re leased. repackaged, stored, or used; or (11) polyvinyl chloride capable of re leasing detectable levels of vinyl chlo ride is manufactured, reacted, released, repackaged, stored, or used. (2) Access to regulated areas shall be limited to authorized employees. (3) A daily roster of employees enter ing regulated areas shall be made and maintained. The rosters, or summaries thereof, shall be kept for at least 20 yean. (e) Monitoring. (1) Every regulated area shell be monitored for detectable levels of vinyl chloride. (2) The monitoring shall assure that any exposure may be determined for each authorised employee with a confi dence level of 95 percent. entry .to regulated areas are proposed, (3> "Closed container" mestin any (3) Employees or their designated rep with provision for access by appropriate container which prevents the release of resentatives shiUl be afforded an oppor OSHA and NIOSH officials. Specific pro vinyl chloride to the environment. tunity to observe monitoring mil measur visions for employee access to monitoring (4) "Contaminated" ni8bns capable ing required by this paragraph. records are included, as well as the re of releasing a detectable level of vinyl (1) Where exercise of an opportunity quirement t*o furnish/ a copy of a medical chloride. requites entry to an area when the use ___ No. 93--Ft. I---- 10 DIMl StOISTW, VOL 3f, NO. V3--ffilDAr, SUV JO, 1*74 BOR 004746 16S8 leorosfo ewes of protective equipment, fa- (31 There shall be teats made for . (J) fmerpencp litnations. (1) A writ ^jiitua, or procedures is required, *uch process or sqragrsent loake and tamemi^ ten openUonal. phm lor nseeigency clothing, equlwnoat, facilities. and pio- riou of vinyl chloride whleb mar result -hn ho developod for eoch it<TMn dull be provided to bH iwiaai from wohepmetiars. lbs frequency oi regulated area. entitled to exercise the opportunity, at no these tests sunII he such as to insure the (3) lit the event of an emergency, ap to Mif Of them. mtcgri!y of equipment and .adherence to propriate r^r* of the plan shall be UU Penoss exercising me opportu proper wwakpraciices. put into operation nity ebaO be Instructed regarding: (3) fJssfrirctory protection. (1> A re*- iii TTnTfi~*~7 created by (A) The toxicity end Are barard of piratazy protection pregram in aooard- the etieapenny sbull be eUminated and vinyl chloride; and trnoe with t TBIO-IM aball be eetabbaharl the aJactad area shall be decontami (B) HupietMttnitif>ftadmMcuMs and implamohUd where niepirmtofw arc nated pdor to the reaumptkm of normal necessary for tbelr protection. req-.drsd to U; used hy this section. operatkma <U) Observes aball be permitted, :) RsfiplrnUra^haU bo used only In (U) Special medical surveillance hy a without interference to the pemois per owos Gf "crecs'jrcr and where required physician ahull be tostlteKnd within 34- forming the monitoring and measuring, by any .-tber provides of this section. hours for amplqyees present in the af to: Rrapiratcrs may net used in lieu of fected are* at the time of the emergency. (A) Observe all stepe and prootdures faaaibfer eugluesrlnc centrals or work- U1D Where an eoeptayee baa e known related to the collecting, processing, snd practice metl-ucla, oontact with liquid vinyl chloride auch evaluation of particular monitoring and (3) Parailvatois or combinations of employee shall 1M remind to shower as measurement samples: letiafri.hrw io~ protection against vinyl soon as possible, union oantrmlndleated <B) Record queatlties and results obtained; (C) Observe the condition of lnonHoi ms and measuring equipment; chlarfci* shall be selected, froci among rim .udowJhK: Ui A positive pressure full faeepieoe astf-otivnuied breathing apparatus; (U) is ptessuve-deRuind full facepiece toy physical lnhntea (lv) An incident report on the emer- sukt shall be reported as required in paragraph (q) (3) of this eecUotv (SI Koch authorised employee shall (D) Receive a demonstration of tb: aaji-oonlaiaed broaUiL-g apparatus op be trained in a program relating to the calibration and function teste of the erating or the pressure-demand mode; hasards of vfayl ehloridc and the pre- monitoring and measuring equipment performed on site; and () wmiwiTM. instructions and docu Uiii .k oendamuon type "C" pressure- der.itntl fall fsjsi?trie xmpimtor optxhr -ho v.yrsture-dycr'Uid mode and fiwttoDiiariftfeiK <0 The program shall Include: (A) Th* nature of the mluaard, and ment* related to the procedures 'end equipment for monitoring and mea3U*> ing. <4) Accurate aud complete records cf all required monitoring shall be made and maintained for not less than 2o years. Such a recofd shall (!) state the date of snob monitoring and the levels determined; and <H) identify the instru ments and methods used. t- ' rgv.' j- desuanc icL'-ccctxtoeti orestbiut: - parairis oferqthsr in the presxurv-deuiai'rt mo'ta: or (It) a comhinn.tioB'tTpe "C" continu ous Low nwnirator end a pressuredemand e-Eii-coutained breathing ap parel! cot rating in the pitssme-dena--4 -rode. the necessary protective steps: (Mi DM natiue of the toxic hararo including local and systemic effects, acute and chronic effects including specifically the carcinogenic hazard; (Cl The specific nature of operations which could risiilt in sxpoaura to vinyl nhierifla and recMsaiy protective stepe; (D) The pmpois for and application (.'.; Protective clefMug. (1~> Employee*: of **'m iH--nw. (f) 'Engineering controls end workpractice methods, (l) 'Where detectable levels of vinyl chloride an measured, immediate protection atwdi be provided, agamst exposure to vinyl chloride by ihe use of engineering controls, workprectlce methods, and respirators as follows; <1) Feasible engineering controls end workpractlce methods shall (Tnmdifttnir be used to reduce airborne oonoentratkms of vinyl chloride below the detect able level; enterin'" regi^a-ed areas shall be pro vided XuU-i..rdr u'-oteciiv-i --.Ir thing, footwe:u' or shce ` ti-itra, and giovut, oi no cost to thciii. -*iic required to wear It while in the r:,p:'.q>sd .-irae. <2) 7. .1045 .rvjij'vijyi chloride powder cjataiolng >ieci.*jle levels of vinyl chlork'j is `i-iati'lcd, emptoyssa shall also be: .)> I'-rirridvd uy; rwr-hsd to reax (b) R;<rfatU to rervive protective K) The purpose tor end application of ceeontaminatica practices; (F) 7 he purpose fer a-it sf^nifle mcc of emergency practices r- -1 procedure, (0) The employee'* ape 'lfic role under normal operating or emergency condlhons; (H) Specific informitlon to aid the emploT(In recognUUm rnd evalubti in if ccjfitionG and tfMraticnn which n ay result in the re;eras of Tiuyl chloriue; (1) The putpnre .7 r *nd appllci.tion (Hi "Wherever feasible engineering controls and wcrkpractlce ' methods which can be Instituted 'immedia&y ere not sufficient to reduce coaceutr&tionc oi vinyl chloride below the detectable level, they Shall nonetheless be used to reduce the concentrations to the lowest prac ticable level, and shall be supplemented by means of respirators in uccotfl^nce with paragraph <g) of this section; (iii) Wherever no feasible engineering control or workpractice method can be instituted Immediately, immediate res piratory protection shall be provided in clothing : e*cj exit nrex; u-'. the regiuaied d.'j> Fr:(',;;-..-i to Grower after the last e;ii; or. ih.e c -7. (3) t iovr- ^'-cfrrti-c cljJbinB shall be provided vhi never cur laminated or soHed, !>ut : it less frequently ihnn weekly. 7o-,:c.t lusted clothirv; gludl l>* decontauitn-tr. J ' e' .'i'e reiwe hy remove iV> l-.nnoeilu'T o: dlsooesi. V, Hyoh.ic jacUUictt turd practices. (1) WTrre rirployeit- urr- req>Ursd bj* this #ec'.ic v he -year protective clothing equiirmeut. cbao'je rooms shah of srecifie ilret aid pre-sedana and prac tices; W) A review of this standard at the employee's first training nnd lndortrilaition program end anmaifc thereafter. id) AC materials relating to the pro gram shall be provided v-on request to wuthorired leereaentativ -J of the Atsi tant Docretan* "*d &r: TMrector. rk) -SIgns jtrj le jefc. c > 7hu~>iicit, uregutaisd arcus shall be posted with Mgns hearing the legend: CAHCTR-SDSraCT AOCJT AUKS. AUTBOgIZkD nBSONPXL ONLY accordance with paragraph (g) of this bo provided hi hccrdonee with (3> Arras containing operations cov section; and j li. ;(i...'i).(` J ered in iioregranh <k) <1) <4) of this sec (iv) In any case covered by paragraph (3) 7.here - cipkiyecr, a:t. loquired bv tion Gholl be posted with, dgns beiri n, (f)(1) (il) or (1H) of this section, the Uiis section lo shower, ab-wrer fact'ltire tho icqeud: employer shall also undertake as soon as shall be pi ovidei '..x accoidanc^ 'ta CANCxr-n T.ran mrir- 1y *ur practicable a program to reduce airborne S iai0.l4l(d)(3). FULL I\rPiVIOD8 AI-E JP."-n 1* BU JI '- concentrations of vinyl chloride below the detectable level, or to the greatest extent feasible, solely by means of engi neering emtaois and woikpractlce meth ods and aa aoon as leaalUe. (3) 3toi;.;;e 01 constunotiou of loo-.i or bcvci u^c-, s'cOi'-gc or -pe of iVLio'diig or ruxt-lc vj chewier px-cthrcifl. ajj^j ihe storage or appf of cesmetics ore prohibited in re^.dated ureas. 3 corr bscicuu A'JTUCWIZPD FJtRjONMSL ONLY Omcc`nets of wusteior other or.xteil.vM cwncndnatod With vinyl chloride ' anrfl ho labeled: msfitai. tf 34TS1, r -. re, ko. rs--jvxnr, iASiy 10, 'WC BOR 004747 ! lJ *5 *V raorosco tuii 16899 TDITL OHKHUDl OOMTAXOtATfeD (U) When veeeels are to be entered, all (1) Alcohol Intake; MATBUAL cmoMt-apgraoT ionT ___ DDNUOV OR DUOOUTAlCMATg USgfG piping to such vessel shall to; - (A) opened. Msnfcsd and tagged; or (B) Where welded piping is in use. not (U) Past history of hapeUtls; (hi) Past exposure to potential bsq^to totoxle agent* Including drum s^V lees than 3 valves in series, which isolate chemicals; . (4) bootalner* of polyvinyl chlorjde the vernal from any other to dv) Fast history of Mood- transfu detectable tonta of vinyl such line, must to closed and secured. sions; and ohlorlds shall bo latotad: (Ill) No employee shall enter a rrenr! (v) Fast history of hospitalisations. yoLTvnm. OHLORIDO oontawb Turn, chloridc except when another employee properly (I) At the time of initial emptoymsnt, trained and equipped for entry la pres or upon Institution of screening, a eerurn vhttl chloride is a ent and Is observing the employee In the specimen shall to obtained for screening OAMaEft-BUSPECT AGENT vessel. Hie observer shall have means with respect to the following Mo-chemi ABSORBED BT BREATHING AMD THROUGH BKIM for signalling for help in the event the cal determinations of liver function: employee experiences problems. Under (I) Total MUruhln; (5) Containers of vinyl chloride shall to labeled: vnm. CHLORIDE danoxb IITMMIIiT FLAMMABLE OAS UNDER FBE06URB__ HAT POLTMERIZB WITH such conditions, the observer sig nal for help, and shall not enter to assist the employee until another person la present to observe. (m) Transportation loading an$ un loading. (l) Facilities for the .loading and unloading of vinyl chloride to and (II) SHMm (III) Serum glutamic oxaiacetic trans aminase (BOOT); (lv) Serum glutamic pyruvic trane- - amlneae (SOFT); and (v) Gamma glustamyl trauspepUdas* (OOTF). explosive force from containers shall have each transfer (4) Additional teste that may option ^ POISON line and vapor-equalizing line equipped ally to considered for use In screening CAMPER SUSPECT AGENT AND ANESTHETIC ____ ABSORBED BT BREATHINO AMD THROUGH SKIN with vent connections, and shall nave an Inert gaa purging system. Vent and purge effluent shall be returned to a proc ess stream or dared In a safe location. Include: (I) Lactic dehydrogenase; (II) Serum protein determinations; (Ih) Serum protein electrophoresis; (6) No statement shall appear on or, (2) Procedures shall be developed and and near any required sign, label or Instruc Implemented for the transfer of vinyl (lv) Platelet count. tion, which contradicts or detracts from chloride. Written copies of such proce (ft) Laboratory analyses for all biologi the effect of any required warning, in dures shall be provided employees en cal specimens Included In medical exam formation or instruction. gaged in such operations, and such em inations shall be performed In labora (1) Maintenance and decontamina ployees shall be fully trained and re tories accredited by the College orf tion. (1) Emphasis sirail be placed upon hearsed in all procedures. American Pathologists or licensed under Immediate clean up of spills, periodic in (3) Employees engaged In transfer op 43 CFR Part 74, spection. prompt repair of equipment and erations shall be provided wftji and ' (ft) If the results of screening required leaks, and proper handling, storage and disposal or decontamination of materials to prevent airborne contamination and accidental ** contact with vinyl chlo ride. Waste materials, equipment, and other sources of vinyl chloride In closed containers, may not be placed In areas of excessive temperature or sunlight since build-up of internal pressure may result .In rupture of the container, fire or explosion. (2) Waste resins or other materials contaminated with vinyl chloride shall be placed in closed containers pending dis 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. (3) 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 posal or decontamination. under local exhaust ventilation which (3) Appropriate procedures shall be developed and implemented for the de reduces the concentration of vinyl chlo ride below the detectable level. contamination or disposal of all such (o) Medical surveillance. Not later waste material, than ------------------- 1974, a program (4) In maintenance or repair opera of medical surveillance shall be Insti tions an contaminated--systems or tuted, and shall provide each authorized equipment, Including vessel entry, em employee with an opportunity for ex ployees engaged In such operations shall aminations In accordance with this para be (1) provided with and required to graph. All medical examinations *nd wear and use a whole-body alr-supplled procedures shall be performed by or suit impervious to vinyl chloride, and a under the supervision at a Hrnnnod respirator In accordance with paragraph - Doctor of .Medicine (MD) or Doctor of <g> of this, section; and (11) required to Osteopathy (DO). All medical examina Bhower after removing protective equip tions and tests shall to provided without ment. cost to theemployee. In paragraph (o) (2) of this section are normal, screening shall be repented: (I) Every six months for empulooyejmes who have been employed in vinyl chj|^ ride related operations for 10 yeaarreel ^H more; and '_ (II) Annually for all other employee;, altering regulated areas. (7) If one or more Uver function tests perforated are abnormal, serum testing shall to repeated as soon as possible, preferably within two to four weeks. If no abnormalities are present upon re- screening, serum testing shall be re peated In three months. (8) If abnormalities persist upon re- screenlng, the employee shall be with drawn from areas where contact with vinyl chloride is possible, and an Individ ualized medical workshop shall be in stituted. Suggested as Initial stops are a complete physical examination and vari ous special procedures such as hepatitis B antigen determination and liver scan ning. If Uver function abnormalities are determined to to unrelated to Uver dis ease. the employee may. to permitted to return to vinyl chloride-related employ ment, subject to .Individual medical evaluation. <5) Protective clothing and equipment' shall be clean and dry for each use. (1) At the time of Initial employment, or upon institution of screening, a physi (9) A complete and accurate record of ' the results of medical examinations shall (6) When vessels or piping systems are opened local exhaust ventilation shall be provided to remove the escaping vapor from all occupied areas. cal examination shall to performed with specific attention to detecting enlarge ment of Uver or spleen by abdominal palpation. to made and maintained for the dura tion of employment plus five years, or for 20 years, whichever is longer. (p) Records. (1) Records of monitor (7) (1) Vessels to be entered shall first (2) At the time of initial employment ing and measuring, medical records, and be ventilated and monitored so that the or upon institution of screening, and an regulated area .entry roster* and sum concentration of vinyl chloride is reduced to a level within the protection factor capability of the protective equipment. nually thereafter, a medical history checklist shall to completed by the em ployee. This list shall include questions concerning: maries, shall to made available for ex amination and copying upon request to authorized representatives of the> .Assls^^ ant Secretary and the Director. FGOMAL MOUTH. VOL 3V, NO. *2--ttlDAV, MAY 10, 1474 004748 bob ifeU) ntorogo cuts hall be transmitted lv registered mall to the Director, and each employee indi vidually notified m writing of this treatoWr. <31 Employ-- and their designated repo--itattres sfeaff be prodded aocaas to '1+mirtm asd CD(V records of nvonltor- toi and Munbi. (4) Fanner wuptayees shall be pto~ vldad acce* to ermme and copy record* reflecting their own oxpoaures. ai Uptm written request of any em ployee. a copy of the medical record of mh employee shaft be famished to a physician designated tv the employee In svBhtmnHt (q> Report*. (1) Not later than--------the following information shall be reported to the OSHA Aiwa Director. Any change In such Information shftH be reported to the OfiBA Area Director wttbtu IS days of mob change, . <D The addrem and location of each establishment which has one or mare regulated areas; and (11) The number of employees In each regulated area dortagnormal operations, tUCIadlng iiSi1--*iii a (3) incident* which result In the relaaie of vinyl chloride into sny area where employees may be exposed shrill be reported in accordance with this pbxogrupft. <1) A report of the occurrence of the tncldmt and tbs facts obtainable at that time hteiudtng a report tm any medical treatment of affected employees shall be maoe within 34 hours to the OSHA Area Director. (ID A written reportshall be flleU with the 03HA Area Director wlthtn 15 calendar days thereafter and shall In clude: (A) A specification of the amount of material released: (Di A OeacrtpUan of the area involved and the extent of known and potential employee exposure and area affected; (C) A report on any medical tmvtmoit of affected employees and any medical surveillance program imple mented: and CD) An analysis of the ctrcnmetanceB of the Incident, and measures token or to be taken, with specific completion data*, to avoid farther similar releases. ( Upon oomplettcn of any moiltoitog and vuuawiling which discloses that imp employee has actually toren exposed to detectable tevel* of vinyl eWorld*, each aueh emptoyee shall be individually noti fied in writing. The notice shall: <11 Be delivered not later than 10 working days after completion of the monitoring and measuring; til) State the actaal exposure in twins of eoncKUrsOan and tome; and <1111 state the stops which haws been taken, are being taken, and will be taken, with gpedfle completion dates, toternl- nato the axpoenre and prevent a main- renee. da; of lUr. 1*74. Jaaor Siarasn, Assfctwf Seerwiw o/ Labor. [TO Doc-to-uma yosd S-S-T<:8:W sm! WSflM --into, VOL S*. MO. *S--IWlSAV, MAT 14k Ito4 BOR 004749 i APPENDIX C COMMENTS ON DRAFT ENVIRONMENTAL IMPACT STATEMENT BOR 004750 Appendix C List of government agencies, private industries, and other groups who have conmented on the Draft Environmental Impact Statement on Vinyl Chloride: 1. Hew England Plastics Corp. 2. John W, Whittlesey 3. Department of Health, Education, and Welfare 4. B.F. Goodrich Chemical Co. 5. Dow Chemical U.S.A. 6. Cities Service Co. 7. Keller and Heckman 8. Shell Chemical Co. 9. Union Carbide Corp. 10. Department of the Army 11. Fabri-Kal Corp. 12. Department of the Treasury 13. Atomic Energy Commission 14. Harvey Hubbell Inc, 15. Americhem Inc. 16. Department of Commerce 17. Goodyear Tire and Rubber Co. 18. Air Products and Chemicals Inc. 19. Industrial Union Dpt., AFL-CIO 20. Council on Environmental Quality \ BOR 004751 \ *f*al v to I kdJ. nblhi / //s::' SX6LM0 PL1S7/CS co,?m / * t W i UV t 910 9ALCM STRCCT WOBUHN, MABBACHUSCTtTB OIOO! AREA CODE 17. 033-0004 July 12, 1974 Mr. David R. Cell Department of Labor, OSHA Office of Standards Development Room 500 1726 " Street, N.W. Washington, D.C. 20210 Dear Mr. Ball: Herewith are ny comments on the Draft Environmental Impact .statement for the Proposed Vinyl Chloride Regulation^ BACHGR01UD The product listing is inadequate. It should mention; phono graph records, packaging films, house siding, 1 billion lbs. of piastifuis, agricultural products, calendered sheet and upnolstery. DKSCniPTXOM OP ACTION .do data is available that demonstrates the latency period for VC.i exposure. it is presumptive. It must be established by human Cj iiiic.. 1 c.ata. PROi-A b_: I)'.PACT Adoption of any VCM level that exceeds present engineering capability '/ill cause a major decrease in productivity and a sign!ileant increase in costs. Tne existence of substitutes is nil, the properties of PVC arc uni aa. It is the only thermoplastic that is naturally flanc re.'iistant. It lends itself to numerous methods of fabrication. It replaces many natural materials that arc expensive, in short supply and aren't as curable. AL'.'nict vTIVHS \ Tne basis for a ban on VCfl or the estaMishmenl- of very low Jovyls of exposure are not bafed on any humnd data, It. is all conjecture. PLANTS 310 *'Al PM 1 MEET ur.ro, MAERACHUBtnS 01001 (oi >; ran coo^ INDU; iC.IAL PARK, 1?b DUCMAINL UfHlt EVARn NEtt llCREOUn. MA -SAEMI |,,,l. rT? P"VR (G17) fi0R 004752 Mr. David R. Bell Department of Labor, nsiin Page 2 CHROMIC TOXICITY - pp 16, 17 & 13 If VCM is a carcinogen everyone who contracted acroosteolysis should dovelon angiosarcoma of the liver. If they haven't, your uryur.iene is lost. (jlevel ICd ) Mo evidence or data or testimony exists that establishes that the experimental animals metabolize VCf! the sane way as human ..beings, nor that liv er fn-.ctions are identical. do data wvmas introduced! as to the liver functions of the rats used in the clinical evaluai .ions, WORKER EXPOSURE Concentration level is conjecture and not quantitative. Most or all of the VCM found in resin i3 released in storage, very little is released in compounding unless rosin is fresh, which, is not common. 4 FABRICATION mp4 5 & _46 _ Estimated number of fabricators 4,000 - 20,000. Who estimated this number? What value is a range as broad as a factor of five (5). #*r-t "i-*' p - r'p* ' ^ ^ J ' r> O You don't understand PVC comnounds. The plnstisol is completely fused, not just the resin, but the entire mixture of resins, plastic izers, stabilisers, etc. all remain in the final product in much the sane concentration as existed for the wet mix. The same is true of flcxibles and rigids. WORKER EXPOSURE pp 49, 50 You state the worker exposure for fabricators is unknown. How can you propose a standard for something you don't know? Your own writing should be sufficient cause for deleting fabricators from the proposed standard. VI PROBABLE ir.pr.CT OP TKK PROPOSED KT.KIDAKD pg GO, etc. The first justification begs the argument. There is no known hazard at levels of 50 ppm or oven 200 ppm. The second sentence that adoption of a level in ambict air. is presumptive, Mo data exists to support standard will result in lower concentrationa N 2nd lhVtVJR.M'h You do not knowf if petrochemicals are an irreplaceable resource. BOR 004753 Page 3 What merit is there,in a human sense,in not fulling a need? This argument would certainly resolve the world-wide food shortage, i.c. '' * . *_ J < -. 1 J 1_ _* ...................... . . .v ^ * 1 - lJd 62 er-t.rel i --w *' c""i years? iuiu conjecture, this correctly. j_ ir*1 T 1 V +_ * ] ^^ t- i-i j i; r. 3 't'Vl"'/ oC ? ^ You con11 11,10*. you kiu^ u i.uo*.o *.'.o P<U L' What is the estimate by engineers of the cost of modifying not only VCM plants, but PVC plants? You offer no data only opinion c-f non-experts, i.e. industrial hygienists, etc. PG 64 LIWES 3*4 You certainly are ignoring the present inflation to say increased costs can be sustained. SUBSTITUTES PG 64 The materials such as wood, metal and rubber not only don't duplicate the properties and cost of PVC but are far more scarce. You do not know .if the raw materials for manufacturing VCM arc non-renewable. They v;ore produced by the earth and there is no evidence that the bio-geological process has ceased. SUMMARY Your Impact Study suffers from a gross lack of facts and conjec ture represented to be facts upon which its arguments are .based. . It must be redone by persons who are scientific and conversant in field. Very truly yours. JCC:gh NOL/'iWD PLASTICS qeUPORAVlOli /J / / (2 John C, Gir.clch Marketing Manager N BOR 004754 ) REGISTERED MAIL SRi^CiAli DaLli/LRY John W. Whittlesey COUNSELLOR AT LAW t0 RANK AVENUE NCW Y0K* N, Y. tOOl? 9l-77 July 15, 197^ Mr. David R. Bell Office of Standards Development Poem 5 00 1726 M.' Street., N.W. Washington, D.C. 20210 Re: Draft Environmental Impact Statement on Proposed Regulation - Vinyl Chloride Dear Mr. Bell: In accordance with Secretary Stender's letter of June 17, 19Y-'+ and the invitation therein to submit comments on the Draft Environmental Impact Statement on Proposed Regulation - Vinyl Chloride, I am making the following, response, as Counsel to Union Carbide Corporation. It seems perfectly clear that the entire draft Environmental Impact- Statement should either be rejected or that its conclusions whicn are wholly without substantial support, should be thoroughly revised and revised. Ho document of this nature, on a subject so important ns the production and manufacture of vinyl chloride mono mer; resins; and of fabricated products containing such resins, should ha accepted or utilized on the basis of what this statement purports to contain. There In here no need to review the lengthy and extensive '.carings that: have just been held an Docket OSH-30 before Judge Jc.ru on My&.it, It va-.s p] ain from personally hearing the evidence presented by NI03H and OSHA, together with the various unions that appeared, that no evidence of any kind or description whatsoever v;as presented shat would warrant adoption of OSHA's wholly preposterous nronosal to limit, employee exposure to vinyl chloride monomer to "no detectable level.1' All the evidence presented, in fact, contratores the need of such a' drastic standard. The OSHA proposal is especially unrealistic in the light of the massive contrary evidence presented by various industry spokesmen (including Union Carbide) that: 1. Not even continuous exposure to vinyl chloride monomer in high concentrations over a period of time will necessarily result in any d .vleterious effects In humans. No evidence of any such effects at level s below 200 parrs per million exposure were shown. - .1- BOR 004755 Mr. David R. Bell -2- July 15, 1974 2. The animal data on vinyl chloride monomer exposure which is the only possible basis cited for imposing any exposure limits. Is not only self-contradictory, inconclusive'and nonprobative in itself, but also cannot be and has not been related or translated into human experience. The testimony on the human experience, as for example, that of Dr. Dernehl, shows that little if any harm has in fact come from employee exposure to vinyl chloride monomer, even over extended periods at high concentrations; see also the Dow Chemical Company testimony that no ill effects on humans at less than 200 parts per million exposure levels were ascertainable from their extensive studies. Indeed, the only allegations in the entire El statement tending to endorse the proposed OSHA standard as appropriate do not state it is presently necessary to curtail exposure to no detectable levels. They merely say (p. 3, for example) that "vinyl chloride concentrations of 50 parts per million may yet pose a hazard." Such statements are clearly the antitheses of factual support for the proposed permanent OSHA standard, and are unquestionably admissions that the standard has in fact no evidentiary \backin?: whatever. It has destroyed any vestige of Justification for Issuance of an OSHA proposal which takes account of a mere speculation and not a reality or a present danger. The fact is, that the only basis cited for setting the proposed vinyl chlaride monomer exposure level below 50 parts per million is the extrapolation of a supposition and not the hard proof required in law to buttress adopting any permanent standard. 3. The claim on page 5 of the statement that the "standard for the most part will likely cause a slight decrease in productivity and small increase in costs for the products made from vinyl chloride" is wholly without justification of any sort whatever. A review of the entire El Statement to ascertain the basis for it is not only unrewarding but shows clearly that it is based on speculation and not solid fact. It is moreover, clearly reliant even for such a slender thread on non-management sources who have neither had nor sought access to the facts. The resort to respirators Is universally accepted, for example, as raising labor costs of production by up to 50$, hardly a minor figure. Also, the only authority for the BOR 004756 57 (2) Worker Exposure In regard to worker exposure during PVC compounding, the PVC resin and the confounds Involved in the processing at this stage contain residual amounts of vinyl chloride in concentrations which may be as high as 3,000 ppm. If the basic resin is stored for some time in bags or drums, it will release an amount of the monomer inside the container which could enter the ambient air upon opening the container. Mixing operations during compounding may allow an additional release of the monomer entrapped in the polymer. Levels in the workroom air are generally below 1 ppm, although evidence presented at the OSHA public hearing of June 25, 1974, shows that excursions above this level are not Infrequent. These studies do not conclusively establish one way or the other whether workers engaged in compounding are exposed to concentrations in excess of 1 ppm. Sufficient Information is not yet available to enable a categorisation of plants into those where concentrations above 1 ppm are likely and those where they are not likely. The highest exposures in this phase probably occur in storage areas, places where containers are opened, and near processing equipment where the PVC is heated. The numbers and types of workers exposed to vinyl chloride during these confounding operations are not known. Trade publications Hat about 200 firms, but give no estimate ofv their sizes. BOR 004757 58 4. Fabrication of End Products from PVC Compounds'*The usefulness of polyvinyl chloride arises from its adaptability to many processing techniques used in the production of intermediate and final goods. These processes have been designed to accomodate a wide variety of plastic compounds, including PVC because of the its ease in processing and its flexibility in allowing for the manufacture of a wide variety of products. In these processes, PVC resins compounded with the necessary additives are converted Into products which need no further chemical handling. The products at this stage may be final goods (such as pipes), components of other equipment (such as wires), or materials for other industries (such as films and sheets for packaging). As a result, products made at this stage may or may not be subjected to further processing, but if so, they will no longer be designated as PVC. The number of firms engaged in this processing stage is not precisely known, but has been estimated to be between 4,000 and 20,000. Such firms range in size from those with few employees and simple equipment to large plants Involving many employees and considerable capital. (1) Process Descriptions The processing of PVC confounds at this stage involves the shaping of the compound into its desired form. This is accomplished by subjecting it to Intense levels of heat and considerable pressure. Several types of equipment are used, according to the final product desired. The major processes BOR 004758 l r 59 used to convert PVC into fabricated products are described below. Extrusion - Both plasticized and rigid PVC formulations (as powder blends or granules) can be extruded (i.e. forced through a die) into a variety of shapes. Determination of the necessary temperatures and other process characteristics, such as rate at which the extrusion is to be carried out, can only be ascertained by careful experimentation. Extrusion is used primarily to produce wire and cable insulation, rigid pipe and tubing, blown film, and unplasticized PVC sheet. Injection Molding - Generally, low-molecular-weight PVC t ealim In l lie liiim of grudiilst or powder blende are used in si lew f ypc Injprl Ion molding nMohlnee. Tlie total Ion of 1 lie screw produces a homogeneous melt which is then injected into a mold at high pressure Blow Molding - This process is generally limited to the production of bottles, and primarily uses powder blends with some lntersperslon of granular compounds. Most of the equipment used in this process produces a prison (i.e. a partially formed mass of material still in plastic form) by continuous extrusion or by the use of a reciprocating-screw system. This parlson is then blown into the proper mold. Compression Molding - This technique is used primarily for processing rigid PVC compounds into phonographic records. Usually, a copolymer of vinyl chloride and vinyl acetate is BOR 004759 I \ i 60 used Co produce a 1 v-vlseoalcy melt. This melt Is mixed aud fused, passed to a two-roll mill from which it is stripped, and then molded by compression in a record press at high pressure. The initial compound can also be in pellet form from which a premeasured molten extrudate Is pressed In a mold. This technique is also the only method used to manufacture thick, high-quality, rigid sheet. Calendering - This technique Is used extensively for the production of flexible and rigid FVC film and sheeting. It Is usually found in conjunction with the mixing of additives rather than as a separate stage in the processing of PVC. Pellets or powder are fed directly to the hot rolls of the calender. The resulting molten material Is carried through finishing rolls to produce rigid sheets or material laminated to a substrate. Plastlsol Processing (Coating) - In this process a paste (or plastlsol) made from PVC resin compounded with various additives Is coated on various substrates such as fabrics, sheet steel, and paper. Several types of equipment may be used to perform the coating. The paste is generally fed Into a device which applies the material to the substrate, either once or several times to achieve the desired thickness. The material is then passed through a heating oven to produce complete fusion of the compounded PVC paste material. N BOR 004760 61 Plastlsol Processing (Molding Methods) - For molding purposes, several methods may be employed to shape a PVC pasts Into Its desired shape. A measured amount of paste may be charged into a mold. The mold is then rotated to cause the paste to gravitate to the walls where it is fused to form a uniform thickness. The paste may also be poured into a mold where it is fused. Low-pressure injection molding is also used to produce PVC shoe soles. Foams - Flexible or rigid PVC foams can be produced by subjecting PVC plastlsol to mechanical or chemical blowing. In this process, the plastlsol is mixed with an inert gas or air which is then fed through spray nozzles under carefully controlled conditions to produce a slowly expanding foam. The plastlsol is whisked and the resulting froth is stabllzed. One of these mixtures is then subjected to heat, while being calendered, extruded or molded, so that it is fused into the desired form. (2) Worker Exposure Exposure to vinyl chloride in the fabricating stage arises from the escape of residual monomer entrapped in the polyvinyl chloride. The monomer escapes at its fastest rate when the compound is heated. In general, the rate and the amount released depend on the residual amount, the extent to which the PVC has been diluted by additives, the type of equipment used for processing, and the temperature at which the PVC Is -v processed. Worker exposure depends on the rate and the amount Bor 004761 \ 62 released, as well as the extent to which the processing area Is ventilated. These factors have yet to be definitively delineated for each type of processing, so that it Is not possible at this tine to state which processes might result In excess exposures. Information presented at the OSHA public hearing of June 25, 1974,indicated that the concentrations of vinyl chloride In fabricating plants fall generally below 1 ppm with a snail number skirting this level. An even smaller number of readings showed concentrations in excess of 1 ppm, ranging as high as 40 or 50 ppm on occasion. However, the Information available as yet shows no clear-cut pattern which could permit a full characterization of exposure levels according to process type. In general the numbers and types of workers exposed to vinyl chloride In Its fabricating Btages cannot be estimated until a scientific sample of the industry is performed. 1 s. BOR 004762 63 > NOTES 1. C. A. Brighton, J. L. Benton, C. C. Marks, and J. P. Dux in N. M. Bikales, ed.. Encyclopedia of Polymer Science and Technology, Volume 14, Interscience Publishers, a division of John Wiley & Sons, Inc., New York, 1971, pp. 305-483. 2. D. P. Keane, R. B. Stobaugh, and P. L. Townsend, "Vinyl chloride: how, where, who - future," Hydrocarbon Processing, February 1973, pp. 99-110. 3. Statement of R. J. Reynolds, Shell Chemical Company, at OSHA hearing on February 15, 1974. 4. "Tight monomer supply plagues PVC producers," Chemical and Engineering News, May 28, 1973, pp. 6-7. 5. D. W. F. Hardie in A. Standen, ed., Klrk-Otfrmer Encyclopedia of Chemical Technology. 2nd ed.. Volume 5, Interscience Publishers, a division of John Wiley & Sons, Inc., New York, 1964, pp. 171-178. 6. "Production processes for vinyl chloride," Hydrocarbon Processing, November 1971, pp. 220-223. 7. L. F. Albright, "Manufacture of vinyl chloride," Chemical Engineering, April 10, 1967, pp. 219-226. 8. Division of Health Standards, Office of Standards Development, OSHA, "Industrial Hygiene Survey Report on Vinyl Chloride and Polyvinyl Chloride Manufacturing Facilities," March 1974. 9. Statement of V. K. Rowe, Dow Chemical Company, at OSHA hearing on February 16, 1974, Appendix II. 10. Statement of the Manufacturing Chemists Association at OSHA hearing on February 15, 1974. 11. Statement of PPG Industries, Inc., at OSHA hearing on February 15, 1974. 12. H. E. Frey, "Polyvinyl chloride resins," Chemical Economic Handbook, Stanford Research Institute, Menlo Park, California, September 1973. BOR 004763 64 13. M. J. R. Cantov in A. Standen, ad., Kirk-Othmer Encyclopedia of Chemical Technology. 2nd ed., volume 21, Intaracience Publishers, a division of John Wiley & Sons, Inc., New York, 1970, pp. 369-412. 14. United States Tariff Comnisslon, "Preliminary Report on U.S. Production of Selected Synthetic Organic Chemicals, November, December, and Cumulative Totals, 1973," Washington, D.C., February 6, 1974. 15. "PVC," Plastics Engineering. December 1973, pp. 25-40. 16. W. A. Cook, P. M, Giever, B. D. Dinman, and H. J. Magnuson, "Occupational aeroosteolysls: II. An Industrial hygiene survey." Archives of Environmental Health. Volume 22, January 1971, pp. 74-82. 17. R. J. Gallueh, "Polyvinyl chloride," Plastics World, August 20, 1973, pp. 66-67, 149-152. 18. Chemical Marketing Reporter. Kay 20, 1974. 19. Comment of Union Carbide Company on Draft Environmental Impact Statement included in Appendix C. BOR 004764 65 V. DESCRIPTION OF ACTION In response co the health hazards of vinyl chloride that have recently become know the Occupational Safety and Health Administration (OSKA) published a proposed standard In the Hay 10, 1974, Pederal Register (Appendix B). Public hearings were held beginning June 25, 1974, to obtain Information from industry, labor, and other Interested parties regarding the provisions of the proposed standard. Information presented at the hearing and In post hearing comments^as well as recently available research data, feasibility studies and this Environmental Impact Statement are being considered in the development of the final standard. Applicability of Proposed Standard The proposal would apply to any company manufacturing or using vinyl chloride or polyvinyl chloride (when the latter releases detectable amounts of vinyl chloride). Detectable levels were defined as those measurable by a method capable of detecting 1 ppm with an accuracy of + 50 percent. Raw polyvinyl chloride resin and the many compounds made from this resin for molding, calendering,extrusion, or other similar processes were considered to have the potential for releasing detectable levels of vinyl chloride. If the PVC confounded resin contains a large proportion of unreacted monomer. Its handling and heating will release some part of that monomer. BOR 00476S I 66 Operations handling fabricated products made from polyvinyl chloride, entirely or in parts, were specifically excluded from the standard. The reason was that the release of monomer from such products had not yet been demonstrated. The proposed standard specified that fabricated products would Include such Items as film, sheet, block, bar, and extrusion stock. Level of Exposure The proposed standard for employee exposure to vinyl chloride was set at the no detectable level^to be determined by a sampling and analytical method capable of detecting vinyl chloride at concentrations of 1 ppm with the accuracy of 1 ppm + 50percent. The method of 1 ppm sensitivity was recommended to OSHA by NIOSH on the basis of its review of the problem. The proposal also attested to minimize the number of workers at risk by regulating areas where vinyl chloride is manufactured, reacted, stored, handled, released, repackaged, or used. Polyvinyl chloride operations containing detectable levels of vinyl chloride were also regulated. The proposal permitted only authorized employees to enter such areas; authorized workers were defined by the proposal as those employees whose duties require them to be In the regulated areas, and those employees who enter such an area as designated worker representatives to exercise their right to observe the monitoring and measuring of vinyl chloride. BOR 004766 i 67 Monitoring A monitoring program was to b required by the proposal to determine if there were detectable levels of vinyl chloride in the workplace and to measure employee exposures on an individual basis. The standard permitted a maximum amount of flexibility for the employer in devising a suitable monitoring system. This was done on account of the diversity of the processing methods involving the monomer, the polymer resin, and the compounded resin. The employer was, however, to be required to monitor in such a way that detectable levels could be perceived and that exposure to an employee could be determined with a confidence level of 95 percent. These programs were to Involve the use of point monitoring devices, portable air samplers, or personal samplers worn by employees. In addition. Section 8(c)(3) of the Occupational Safety and Health Act requires that employees or their designated representatives be provided an opportunity to observe monitoring. Engineering and Work Practices If detectable levels of vinyl chloride were present under normal operating conditions, the employer was to be required to Immediately institute engineering controls, work practice methods, and respirators in accordance with the proposal. Engineering \ controls and work practices were considered preferable to other methods of compliance, since they focus on eliminating contam ination of the air in the workplace rather than on simply providing a temporary s lutlon. BOB 004767 68 The prop sal also required that tests be conducted for process or equipment leaks to ensure the Integrity of the equipment and the propriety of work practices. In the event that these control measures were Insufficient to control airborne concentrations of vinyl chloride, lnnediate use of protective respiratory devices was to be required. Respiratory Protection Zn the event that respiratory protection would be required under normal or emergency situations, the employer would be required to select equipment from among the following types: " Positive pressure full facepiece self-contained breathing apparatus; 0 Pressure-demand full facepiece self-contained apparatus operating In the pressure-demand mode; * Combination type "C" pressure-demand full facepiece respirator operating In the pressure-demand mode and a pressure-demand self-contained breathing apparatus operating In the pressure-demand mode; or * Combination type "C" continuous flow respirator and a pressure-demand self-contained breathing apparatus operating In the pressure-demand mode. ProtietIon against vinyl chloride was not considered reliable from cartridge type respirators due to the short break-through time for vinyl chloride at high concentrations. As a result, NIOSH BOR 004768 i I ! 69 recommends the use of continuous flow and pressure-demand types of respirators. Respirators were not to be used instead of feasible engineering controls or work practice methods. Protection in Special Situations (1) Maintenance and Decontamination The proposed standard recognized that VC and PVC operations are frequently conducted in batch processing equipment requiring frequent cleaning to ensure the purity of the process. The proposed standard required special precautions for cleaning operations designed to maintain or decontaminate equipment. Some types of equipment, such as reactors in the polymerization process, were believed to allow significant buildups of vinyl chloride. The proposed standard required adequate venting of such vessels to remove escaping vapor from occupied areas before worker entry. In addition, employers were to provide workers with whole-body, air supplied suits impervious to vinyl chloride. Workers were also to be required to shower after removing such equipment. The proposal emphasized the immediate clean up of spills, periodic Inspections, and the prompt repair of equipment and leaks. Provisions also addressed the proper handling, storage, and disposal of materials to prevent airborne contamination and accidental skin contact. (2) Transporatlon Loading and Unloading The loading and unloading of vinyl chloride presents a v special problem for the escape of vapors at detectable levels. BOR 004769 I I I 70 The proposed standard required that each transfer line and vaporequalising line be equipped with vent connections and have an inert gas purging system. Vent and purge effluent would be returned to a process stream or flared in a safe location. The proposal required that procedures for the transfer of vinyl chloride be developed and implemented. (2) Emergency Situations Operations Involving the monomer have the potential for creating emergency situations In which significant leaks or spills occur. The proposal, therefore, required that a written operational plan for emergency situations be developed for each regulated area. Each employee was also to be trained to under stand the hazards of vinyl chloride and the precautions for Its safe use. In the event of an emergency, the decontamination of the affected area would be required before the resumption of normal operations. Special medical surveillance was also to be Instituted within 24 hours for employees with known contact with VC. These employees were to be required to shower as soon as possible. Medical Surveillance Vinyl chloride in sufficient concentrations Is known to cause changes In liver function. Elver dysfunction Increases risk to health, possibly preceding the development of liver angiosarcomas. NIOSH has recommended the medical regulations BOR 004770 I 71 included in the proposal as reasonably appropriate to detect liver dysfunction. If specified biochemical determinations of liver function tests were abnormal, further screening was required. The employee would also be required to be withdrawn from areas where contact with vinyl chloride was possible. Miscellaneous Requirements (1) Waste Materials The proposed standard required that waste materials be appropriately disposed of or decontaminated. (2) Protective Clothing The proposed standard required that each employee entering a regulated area be provided with full-body protective clothing, footwear or shoe covers, and gloves at no cost to them. The protective clothing required by the proposal would not only minimize skin contact with vinyl chloride vapor but would also protect the employee from splashes in the event of a spill or rupture of equipment containing liquid VC. Employees were to be required to remove all protective clothing upon leaving the regulated area. (3) Hygiene Facilities and Practices Shower facilities and change rooms were to be required under certain circumstances. Storage or consumption of food and beverages were to be prohibited in regulated areas. BOR 004771 \ 72 (4) Signs and Labels The proposal specified the signs and labels required at entrances, In regulated areas, on containers of waste materials contaminated with vinyl chloride, on containers of polyvinyl chloride containing detectable levels of vinyl chloride, and on containers of vinyl chloride. (5) Reports and Records The proposed standard required that monitoring and medical records be maintained for 20 years. In addition, reports identifying companies which have regulated areas, as well as other information, were to be provided to OSHA. Provisions regarding employee access to monitoring records were also Included. S BOR 004772 73 VI. PROBABLE IMPACT OF THE FINAL STANDARD* Sine* January 1974, when the human carcinogenicity of vinyl chloride firat became evident, significant measures were taken throughout the vinyl chloride and polyvinyl chloride Industries to protect workers (as well as consumers of final products) by reducing the amounts of vinyl chloride to which they might be expqsed, 1 ' 7 The Initial Industry-wide efforts were relatively easy to institute as compared to the goals which are sat by the proposed standard. The coat of continued reduction In exposure would be Increasingly significant in industry and would ultimately be passed to the consumer. 1. Reduction in Worker Risk Achieving a safe and healthful workplace in an effective and equitable maimer has been OSHA's goal in the development of a standard for vinyl chloride. The available data Buggest that to reduce worker risk, one must reduce to the maximum extant feasible worker exposure to vinyl chloride. The animal studies and epidemiologic information (discussed more fully in chapter III) strongly suggest a cause/effect relationship between exposure to vinyl chloride and certain types of liver cancer, including angiosarcoma. The data also *Note: References in this section have been selected as representative of testimony presented at the OSHA hearing of June 25, 1974. The cited references are in general not unique. BOR 004773 t 74 suggest that lower exposure levels are correlated to lower risk of occupational disease from vinyl chloride. However, the epidemiologic evidence Is too Inconclusive to estimate dosereeponse relationships with precision. Because the comparabil ity between human and experimental an<nu1 physiology Is not completely understood, the animal data provide only approximations of human susceptibility. Although the possibility of a threshold level of tumor Induction may exist, the available scientific evidence does not establish a threshold level for vinyl chloride. In addition, the metabolism of vinyl chloride in the human body has not been conclusively delineated, and no proximate or ultimate carglnogenic metabolltles have been demonstrated. Although knowledge of the quantitative relationship between vinyl chloride exposure and Induction of human liver angiosarcoma is lacking, the experience of workers exposed to vinyl chloride and of animal studies provides cogent reasons for regulating workplace exposure. One of the primary Impacts of the proposed standard will be to reduce. Insofar as practicable, the risk of employees developing occupational disease from exposure to vinyl chloride. 2. Expected Impact on Industry The vinyl chloride industry In the United States has become a vital component of the national economy since VC was first 2 produced In 1930. Applications of PVC tend to proliferate as rapidly aa available supplies permit; even though there are few BOR 004774 i i 75 market innovations. PTC has replaced many other materials because of Its superior qualities. The history of PVC is replete with examples where, once It has penetrated a particular market, q it has assumed a position of dominance. Prior to the current concern for reducing health hazards associated with exposure to VC, the industry was already somewhat unstable as VC production depends on the availability of petrochem ical feedstocks which have been in short supply. The appearance of the OSHA standard may upset the existing uneasy balance; however, prediction of the exact nature of the impact on this complicated industry is fraught with uncertainties. (1) Cost of Compliance The most direct Impact of the OSHA standard on industry will be the capital costs for implementing engineering controls and for purchasing monitoring, respiratory, and miscellaneous equipment. Monomer, compounding, and fabricating plants are likely to be less affected than polymer plants. According to industry estimates, the engineering changes required in polymer plants could well cost as much as the original capital expendltures for the plants. * Firestone estimates3 a coat of $55 million to attempt to achieve a "no-detectable" level at two PVC plants. Altogether, approximately 37 plants would be required to make major investments. The main sources of exposure in monomer plants are operations involving tank car loading, in-plant sampling, and laboratory BOR 004775 76 analysis. Additional emissions may come from pr cess venting and from fugitive sources such as pumps, flanges, and valves. Coats for equipment to control exposures associated with tankcar loading and process venting will be substantial. Capital costs for the other items will be much less, since the emissions from these sources can be reduced primarily by work-practice methodology. Costs for replacing pumps, flanges, and valves to provide more leakproof equipment may be necessary. Engineering changes to reduce emissions from these sources will be also substantial, and the capability of achieving 1 ppm may not be technologically and economically feasible for all plants. Compared to engineering costs, expenditures for monitoring instrumentation, respiratory protective devices, and other equip ment will be relatively low. In general, the capital expenditures and time required to reduce VC concentrations to acceptable levels may be substantial. Capital coats for compliance with the proposal in compounding and fabrication plants are not expected to be particularly 4 high, but they still may be significant for some smaller companies. In these plants, the greatest expenditures are expected to be for ventilation and monitoring equipment. Most companies already have Installed ventilation equipment to control dust problems. The cost of monitoring equipment may be several thousand dollars, but should be within the financial capability of large companies. For small companies, such purchases may be sufficiently \ prohibitive to upset their competitive position. However, such BOR 004776 79 likely be rapidly replaced by an increased demand elsewhere. There seems little likelihood of any total movement away from PVC unless it appears that U.S. industry cannot control the exposure hazards. (3) Imports and Exports^ Vinyl chloride and polyvinyl chloride currently constitute relatively minor products in international trade. The demands for PVC resins are so great that each producing country is hard pressed to meet its own needs and is able to export very little. This situation will probably remain static for the foreseeable future, although an increase in prices caused by the OSHA regulation could alter this stability. If domestic prices Increase substantially, PVC users may be able to obtain resins from manufacturers in countries where regulation is less strict. This is not likely to occur in the short run because of internal demands in all countries. In the long run, U.S. companies might find it profitable to build plants abroad. In any event, the extent to which the OSHA standard may impair the trade situation cannot be assessed at present, but some increased imports are expected. (3) Miscellaneous Impacts The OSHA standard may necessitate increased energy consumption in polymerization plants.-* Increases in energy demand will BOR 004777 i ! 80 not be as great In monomer, compounding, and fabricating plants, although some rises nay occur. An adverse environmental effect of the standard may be a t t ;>ry Increase In the amount of vinyl chloride entering the atmosphere as plants seek to eliminate VC from the workplace. Since vinyl chloride will readily disperse in the atmosphere, the increased background level of VC in the ambient air resulting from the standard will probably not be significant. The Environmental Protection Agency is examining the significance of levels presently found around various types of plants and will determine the necessity of imposing regulations to deal with VC emissions. S BOR 004778 i NOTES 81 X. Statement of Ralph L. Harding, Jr., Society of the Plastics Industry, at OSHA hearing of June 25, 1974 (Exhibit 20-B). 2. Statement of Viicent P. Ficcaglia, Arthur D. Little, Inc. at OSHA hearing of June 25, 1974 (Exhibit 20-F). 3. D. P. Keane, R. B. Stobaugh, and P. L. Townsend, "Vinyl Chloride: How, Where, Who-Future," Hydrocarbon Processing. February 1973, pp. 99-110. 4. Statement of Anton Vittone, B. F. Goodrich Chemical Company, at OSHA hearing of June 25, 1974 (Exhibit 20-D). 5. "Statement of Position of Firestone Plastics Company" presented as Exhibit 48-C at OSHA hearing of June 25, 1974. 6. Statement of John L. Nelson, R, F. Goodrich Chemical Company, at OSHA hearing of June 25, 1974 (Exhibit 27-A). 7. Statement of K. H. Oelfke, Dow Chemical Company, at OSHA hearing of June 25, 1974 (Exhibit 24). 8. Statement of Rodney P. Becker, Diamond Shamrock Chemical Company, at OSHA hearing of June 25, 1974 (Exhibit 20-R). 9. Statement of Louis J. Molinlusl, Gillot-Analytical Service Corp., at OSHA hearing of June 25, 1974 (Exhibit 20-0). 10. Statement of Michael J. George, Canvas Products Association International^at OSHA hearing of June 25, 1974 (Exhibit 16). 11. Comment of Dow Chemical Company on Draft Environmental Impact Statement reproduced in Appendix C. N BOR 004779 l t 82 VII. ALTERNATIVES The proposed OSHA standard Is based on an evaluation of wny factors* vest of which are not readily quantifiable. In its development, many alternatives, both in general approach and in specific provisions, were evaluated. Although the limited amount of available time has precluded a definitive analysis of all the relevant factors, each section of the standard was based on a careful weighing of the available evidence. This chapter describes the major alternatives that were considered during the development of the proposed standard. 1. ALTERNATIVES CONCERNING THE SCOPE AND APPLICATION OF proposed STANDARD Polyvinyl chloride (containing entrapped vinyl chloride) eventually finds its way to companies which constitute over 10 percent of the national economy. Because of its widespread industrial use, the breadth of the standard's applicability has always been an Important consideration. Polyvinyl chloride, even in products used by the general consuming public, apparently is always capable of releasing vinyl chloride. Thus, one alternative to the proposal would regulate all industries where VC er PVC might find application. This alternative is not supported by the data; the release of VC by most finished FVC products has not been documented. Once FVC has been heated to the point where it fuses, the amounts of vinyl chloride that can be released, generally seem to be substantially reduced. It \ appears that finished or semi-finished FVC products are not capable BOR 004780 of releasing measurable amounts of vinyl chloride as long as they are not further subjected to temperatures such as those used in processing. The position has also been proposed that compounding and fabricating plants handling FVC need not be covered by the OSHA regulation, but should be regulated by a separate standard. Indeed, it appears that no detectable or low levels of vinyl chloride will be observed in most compounding and fabricating plants. Although there appears to be little or no VC in the breathing zones of most workers in the majority of these plants, measurable and perhaps significant amounts of vinyl chloride can build up Inside heating and mixing vessels and in storage areas. A significant amount of PVC used by fabricating companies is in pellet form. Since PVC pellets have already been subjected to processing temperatures, it is conceivable that most of the vinyl chloride that may have been entrapped in the PVC would have been released on this basis. The position has been advanced that BOR 004781 84 FVC pellets do not constitute a significant source of vinyl chloride and that fabricators using pellets do not need to be regulated. However, these pellets are subjected at other points in their processing to high temperatures, and It Is not clear that further releases of VC do not occur. Another alternative that has been raised Is to distinguish between monomer and ploymer plants. Since these operations pose significantly different sets of hazards which may need to be regulated accordingly, It has been proposed that the OSHA standard reflect such differences. It Is possible that the monitoring .provisions may affect many companies where VC hazards will not be found. It seems necessary to Identify those companies where potentially hazardous exposures may occur. On the other hand, the exclusion of firms using finished or semi finished fabricated products Is not likely to exclude establish ments with measurable levels of VC. 2. ALTERNATIVES COKCEKNING LEVELS OF EXPOSURE At any level of exposure except zero (which In effect would ban vinyl chloride manufacture), there may be a risk that a worker will contact liver angiosarcoma. However, a complete ban, causing a total shutdown of vinyl chloride or PVC plants, would severely disrupt the economy and worsen the employment situation. In all likelihood, a shutdown of VC and PVC plants would reverberate throughout the economy by effecting work stoppages in important sectors of the economy. N BOR 004782 i I > 85 At the OSHA public hearing of June 25, 1974, many polymer producers stated that a requirement to reach a level of "nodetectable" VC upon the effective date of the standard would require them to shutdown. The producers claimed that the requisite technology to achieve a "no-detectable" level simply is not available; therefore, employees would be required to wear respirators at all times. The companies indicated that plants would close rather than attempt to meet this requirement. In anv event, where engineering changes are needed, some time would be required. Another alternative is to establish the permissible permanent level of exposure at or below 50 ppm. Risk estimates based on animal studies suggest the prudence of attaining TWA levels of exposure as low as feasible in all plants. 'S BOR 004783 I \ 86 3. STAGING OF COMPLIANCE Considerations of practicality must enter into the decision as to when companies will be required to comply with the particular provisions of the standard. As indicated at the hearing, many monomer and polymer producers already have initiated most of the actions needed to meet monitoring requirements. A problem arises with respect to the compounders and fabricators. If the alternative of immediate compliance with the monitoring procedures were adopted, industrial sources point out that the laree number of companies involved would induce a severe shortage in supplies of monitoring equipment and of industrial hygiene consultants. In evidence presented at the OSHA hearing of June 25, 1974, industrial sources claimed that a standard requiring immediate compliance to the proposed "no-detectable" level is not technically feasible in view of the massive engineering alterations that may be required. If companies are required to meet the exposure level goal stipulated in the proposed standard, the companies have alleged that the practical effect would be to require employees to wear respiratory equipment at all times. A substantial amount s. of testimony was presented at the public hearing describing the difficulties of reliance on personal protective equipment. Some respiratory equipment i8 bulky and BOR 004784 I 87 cumbersome. Wearing certain types of this equipment continuously may strain workers, perhaps lessening their alertness. Some workers could suffer a claustrophobic effect and would be unable to use some equipment at all, even for short time periods. In addition, monomer plant layouts require workers to climb narrow ladders and traverse narrow catwalks in the normal performance of their duties, thus creating a potential safety hazard. 004785 BOR 88 VIII. RELATIONSHIP TO OTHER FEDERAL ACTIONS Production workers constitute the part of the population most obviously exposed to the hazards of vinyl chloride. However, in view of the fact that polyvinyl chloride products contain residual amounts of vinyl chloride which may be released, the general population may also be exposed,though as yet to an un determined extent. Since vinyl chloride and polyvinyl chloride products find many uses throughout society, several Federal agencies in addition to OSHA have become concerned about possible population exposures to vinyl chloride. These agencies focused initially on the exposure that arose from the aerosol use of vinyl chloride; subsequently, efforts have been Initiated to determine the extent to which vinyl chloride exposure occurs in other uses and the precise extent to which such exposures constitute a problem. 1. REGULATORY ACTIVITY Historically, the only consumer use of vinyl chloride in monomer form has been as an aerosol propellant for hair sprays, pesticides, and other aerosol products. Tests conducted by the Environmental Protection Agency (EPA) and reported in the Federal* Register on April 26, 1974, revealed that a VC aerosol released for 30 seconds sometimes produced concentrations as high as 400 ppm in the air of a closed room. By that time, manufacturers nf aerosol hair sprays and pesticides indicated that they had voluntarily ended, in 1973, the use of vinyl chloride as a pro pellant, Nonetheless, some products containing vinyl chloride BOR 004786 89 probably still remained on the market even after this date. As a result, on April 26, 1974, EFA announced an emergency suspension of all pesticide spray products for indoor use containing vinyl chloride and also gave notice of its intent to cancel the registration of these products. At the same time, EFA requested that all existing stock of such products be recalled by the manufacturers. On April 22, 1974, the Food and Drug Administration (FDA) published two proposed rules: one which would regulate the use of vinyl chloride as an ingredient of aerosol drug products such as in the form of a propellant; and another which would regulate the use of vinyl chloride as an Ingredient (propellant Included) of cosmetic aerosol products. Since evidence Indicated that some supplies of hair sprays containing vinyl chloride were still on the market, FDA requested that all manufacturers initiate recalls ter such hair sprays as well as for other drug and cosmetic aerosol products containing VC. On May 9, 1974, the Consumer Pro duct Safety Commission comnenced an information gathering process to determine the specific aerosol products which now use or have used vinyl chloride. It may ban the use of VC in aerosols for such products as spray paints, household cleaners, and de-greasing agents. Significant programs are currently underway to determine other areas where vinyl chloride or polyvinyl chloride formulations % should be regulated. The Department of Transportation (DOT) currently regulates the shipping (46 CFR 145.24-100) and BOR 004787 90 transportation (49 CFR 172.5) of vinyl chloride as a flammable compressed gas. The containers that may be used are specified by these regulations. At present, DOT is considering whether any changes in its regulations are warranted by the fact that the chemical has been identified as a carcinogen. The major-issue is * whether a single exposure to the chemical can cause cancer. At present, DOT is considering changes in labeling requirements, but not necessarily in packaging regulations. The Environmental Protection Agency is currently collecting and assessing data on: (1) the ambient emission and effluent levels of vinyl chloride in air and water from VC and PVC manufacturing plants; (2) the environmental Impact of all disposal methods for vinyl chloride and polyvinyl chloride wastes; (3) the overall ecological effects of vinyl chloride. EPA has also collected data in a preliminary monitoring program covering seven industrial complexes containing 10 PVC and 2 VC plants. Similarly, it is receiving data concerning emissions and control from the VC/PVC industry under Section 114 of the Clean Air Act. The results of these studies will determine the need for EPA regulations. At present, certain polyvinyl chloride formulations are sanctioned for use in food packaging, and hence are exempt from classification as food additives subject to pre-marketing clearance by the Food and Drug Administration. Early in 1973, FDA S received reports that vinyl chloride was migrating to the interior surface of polyvinyl chloride bottles then being test marketed for alcoholic beverages. Use of polyvinyl chloride bottles for this BOR 004788 91 it * purpose ceased after the Commissioner of FDA issued a proposal which concluded that polyvinyl chloride bottles nay cause the adulteration of alcoholic beverages. There have been further reports of migration when polyvinyl chloride is used as an ingredient of containers for non-alcoholic products. Therefore, FDA has requested information on the extent of polyvinyl chloride usage by type of container and type of product, on the vinyl chloride content of polyvinyl chloride used to manufacture such containers, and on the level of and rate at which vinyl chloride can be extracted from such containers under certain test conditions. FDA nay establish maximum levels for the amount of the vinyl chloride that can be extracted from such polyvinyl chloride packaging. FDA has also requested that manufacturers submit information on every drug product containing vinyl chloride as an ingredient or packaged in polyvinyl chloride containers. FDA currently does not know whether vinyl chloride is being used in the manufacture of drug products. 2. RESEARCH STUDIES Despite the fact that vinyl chloride and polyvinyl chloride have been present in large quantities in the U. S. for many years, little is known about their health effects. As a result, many studies have been initiated during the past several months, and others are being proposed. N BOR 004789 92 The Center for Disease Control (CDC) Is conducting a national search for all deaths from angiosarcoma of the liver which have been reported since 1965. For each case identified^ the health history of the individual will be reviewed and analyzed to determine whether or not there had been any exposure to vinyl chloride or polyvinyl chloride. CDC is also conducting studies to determine deaths from other causes that may be related to exposure to vinyl chloride. In these studies, pathological information will be obtained from hospitals. A survey among meat wrappers in Houston, Texas presently underway will determine whether vinyl chloride released from polyvinyl chloride packaging materials may be the cause of "meat wrappers asthma." The National Institute for Occupational Safety and Health (NIOSH), an agency of CDC, is conducting several studies on various aspects of the vinyl chloride question. The most significant effort is a comprehensive epidemiologic survey of workers from 11 polymerization and fabricating plants. Employee medical records are being subjected to intense screening to determine the scope and magnitude of vinyl chloride effects. All hospital data obtained in this study is being sent to CDC for its angiosarcoma search. NIOSH is also planning studies to determine if cosmeticians exposed to vinyl chloride from aerosol hair sprays have contracted any cases of liver angiosarcoma. NIOSH is examining the types of monitoring equipment that would be feasible for use in the workroom environment. The primary problem in this respect is developing monitoring equipment of greater sensitivity than was necessary in BOR 004790 in the past when the principal concern was the explosive potential of vinyl chloride. The Environmental Protection Agency will conduct epidemiologic studies of the neighborhoods surrounding selected VC and PVC production plants. In addition, studies are being made of the effects of vinyl chloride on developing rat fetuses, the effects of other stresses (such as ethanol and vinylidene chloride), and the importance of nutritional factors in vinyl chorlde toxicity. The National Cancer Institute is conducting some cell culture stndles to discover the carcinogenic mechanism of vinyl chloride. The Fish and Wildlife Service of the Department of Interior is concerned about the ecological effects of polyvinyl chloride piping, since the residues from such piping seem to give rise to liver problems in fish being raised in hatcheries. No clear statement as to the ultimate cause has been proposed, although a possible source of the problem may be the plasticizers used with the polymers. ' The National Bureau of Standards (NBS) is performing some preliminary investigations into the development of permeation tubes which could serve as more accurate calibration sources for vinyl chloride monitoring equipment. NBS is also examining the mechanism by which residual vinyl chloride escapes from the polymer. 9* 94 IX. COMMITS Those comments which have been submitted in direct response to the draft environmental Impact statement on vinyl chloride are included as Appendix C to this report. In addition, the testimony of witnesses at the OSHA public hearing on June 25, 1974, was permitted to stand as consents on the draft statement. Accordingly, the discussion of the comments presented in this chapter will attempt to treat the complete record of the public hearing. Although some of the contents presented at the public hearing are reflected in those included in Appendix C, this appendix does not show the full range of the testimony presented at the public hearing. Since the testimony at the public hearing was not specifledlly directed at the impact statement, but more dlrectlv addressed the substance of the standard, no attempt is made to reproduce it here. The testimony presented at the hearing and the consents on the draft environmental Impact statement fall into three main categories: critiques of sections of the dfaft environmental impact statement; background information on the nature of the health effects of vinyl chloride, the sources of occupational exposure, and the methods of dealing with the hazard; and critiques of the provisions in the proposed standard (Appendix B). The first category is relatively small, since few participants at the hearing commented directly on the statement and few responses have been received during the period provided for public comment. BOR 004792 95 1. Comments on Draft Environmental Impact Statement The comments shown in Appendix C primarily address the same issues as those discussed in the other two sections of this chapter. In addition, they also address specific statements made in the draft of this report. These latter comments fall into two categories: (1) those dealing with statements of fact; and (2) those dealing with the general tone and Interpretation of data made in the draft Impact statement. Suggested changes arising with respect to statements of fact have been accepted and are incorporated in the relevant portions of this final statement. The second category of comments was concerned primarily with the discussion of the impact and the alternatives included in the draft. Since these same issues were dealt with by witnesses appearing at the public hearing, particularly in their predictions of the impact of the proposed standard, the relevant chapters (VI and VII) have been revised to reflect these comments. 2. NATURE OF BACKGROUND INFORMATION PROVIDED A large number of witnesses at the public hearing presented evidence directly bearing on the health hazards associated with vinyl chloride. Generally, this testimony falls into the following areas: o Carcinogenicity of vinyl chloride in animals - Results of animal experiments - Interpretation of experiment results \ BOR 004793 96 Problems of extrapolation of results from animals to humans - Mechanism of vinyl chloride carcinogenesis - Unknown areas that await further study o Carcinogenicity of vinyl chloride in humans - Results of clinical studies - Results of epidemiologic studies - Problems in diagnosing angiosarcoma of the liver - Interpretation of results of studies in terms of a "safe" level of exposure for humans This testimony has been evaluated and incorporated into Chapter III of this report insofar as was possible in the time available. The second major area of information provided at the hearing was the results of monitoring studies designed to identify the current levels of exposure in several types of plants and operations. Witnesses provided the following types of information: (1) the major sources of vinyl chloride in the workplace, identifying the types of equipment which constitute the major problems; (2) exposure levels observed in the plant and related to worker job categories; and (3) the relationship between residual monomer levels and the existence of an exposure hazard in compounding and fabricating plants. This information was provided for monomer, polymer, compounding, and fabricating operations^ Much of this information has been provided in post-hearing comments which have been included in the hearing record. At this BOR 004794 97 rim*, the patterns that can be discerned from the data are relatively general In nature. To the extent possible) this information has been incorporated into Chapter IV. The third major type of information provided at the hearing bears on methods for dealing with exposures in the various plants and operations. The primary areas of discussion dealt with: (1) methods of monitoring to detect the presence of vinyl chloride; (2) the ability of respiratory equipment to reduce exposure; and (3) engineering changes and work practice methods that could reduce exposures in each of the types of plants and operations. N BOR 004795 98 3. COMMENTS OS PROVISIONS OF TPE PROPOSED STANDAFP Testimony presented at the public hearing and comments received on the draft environmental impact statement dealt with the ability of the affected companies to comply with its provisions. The comments fall into two categories: (1) those discussing the feasibility and effect of the proposed standard taken as a whole; and (2) those dealing with specific provisions of the proposed standard. In the first category of comments, witnesses described the structure of the PVC industry, demonstrating the interdependence of its various parts and the relationship to other parts of the economy. Vitnesses demonstrated the effect of the proposed standard if certain of its requirements were imposed on industry. Industry witnesses were concerned with the technological feasibility of complying with the standard as proposed, specifically, the feasibility of Installing engineering controls to achieve a "no detectable level". These issues are discussed in Chapter VI and VII. The second category of comments on the proposed standard concerned specific language that was used. In most cases, the comments reflected the difficulties of interpreting certain provisions. In particular, these comments addressed the following parts of the proposed standard: (1) definitions of the N terms "authorized employees," "contaminated," decontamination," "detectable level," emergency, "exposure," "fabricated product," and "waste resin;" (2) the accessibility of records to employees; (3) the nature of engineering controls for different types of BOR 004796 99 operations; (4) the necessity of certain requirements for hygiene facilities and practices and for protective equipment; (5) interpretation of the confidence level requirement for monitoring; (6) the necessity of specifying the medical surveillance requirements in detail; (7) the language to be used on signs and labels; (8) the correctness of the specifications for respiratory equipment; and (9) the length of time for record retention. A consideration of these comments have been incorporated into the discussion of the provisions of the proposed standard. Bor 004797 l I 77 companies may be able to satisfy their monitoring requirements by contracting for the services of industrial hygiene consultants # rather than by purchasing equipment themselves, thus avoiding the capital cost of monitoring equipment. the capital costs In polymer plants are likely to be substantial. Plants in this industry are so diverse that some may lose their competitive position, especially smaller firms with older equipment whose operations are already marginal. Previously, the heavy demands for PVC had ensured the continuance of such companies, but compliance with the proposed standard may prove to be an excessive strain. Several employers may find it necessary to close operations, concentrating the Industry intofewer companies and causing disruptions of several markets. It Is also possible that demand for PVC would in the long term induce some companies to enter the market with larger and safer Diants. Substantial increases in energy requirements and in number of personnel may significantly increase direct operating costs. According to an Industry spokesman, decreased efficiency of the equipment and lowered worker productivity may also have a signifi cant impact on operating costs.In all likelihood, a substantial price Increase may be necessary to insure the viability of the industry. Since demand for PVC is_Stong and users have'become dependent on this material, price increase will likely be accepted. BOR 004798 78 In situations In which several suppliers produce the same v'rC product, the competitive position of individual -companies may be seriously affected. However, the diversity of PVC types and characteristics may limit this type of impact to a small fraction of the companies involved. The standard may slightly improve the utilization of vinyl chlorid feedstocks, since less would escape during processing and more would 7- be reacted during polymerization. (2) Substitutes^ At present, there is no known material or materials which could substitute adequately for all the vide range of PVC uses. Historically, identification of a chemical as a carcinogen has resulted in an Increased search for substitutes and a gradual decrease In its uss. Howsver, few previously identified chemical carcinogens have had a volume of production close to that of vinyl chloride. While there are substitutes for almost every use of polyvinyl chloride, such materials have basn long abandoned for various reasons, such as scarcity, cost, snd their inferiority to PVC. Furthermore, most PVC users indicated that they are now too dependent on this substance to permit a very rapid switch to other materials. Thera is no evidence yet of a lessened demand for PVC (Implying a concomitant shift to substitutes). The search for adequate substitutes may be heightened as the price of PVC resin increases, but any slackening of demand In one area ^ould BOR 004799 Fal)ri-Kal Corporation 3 3 0 3 E a 9 t Cork St. / Kcicmatoo, Mich -19 0 0 1 / 6 1 6 July 19, 1974 -4 V Mr. David R. Bell Office of Standards Development Room 500 1726 M Street, N. W. Washington, D. C. 20210 Re:. Draft Environmental Impact Statement on Proposed Regulation Vinyl Chloride Dear Mr. Bell: To be sure our commentary thereon is in all appropriate hands, we are attaching a copy of our submission related to Docket OSH-36, OSHA hearing, We feel this is the most relevant data we can present specifically noting that the actual data of real operating PVC procedures and the pertinence, or lack of it, for the converting end of the industry are features which dictate against the proposed regulation. We would appreciate your making this statement part of the record. Very truly yours FABRI-K^t. CORPORATION RPK:d Attachment R. P. Kittredge - President SJ Mr I 9 ! U I' : .> Q u i I : u I ?' ll i> f i n c . f / . r; BOR 004800 Fabri-Kal j?j ti ` in*< June 28, 1974 POSITION STATEMENT Re: Vinyl Chloride Proposed Standard (Docket OSH-36) (29CFR Part 1910) A.. Background: Fabri-Kal Corporation was founded in 1950 in Kalamazoo, Michigan, pri marily to engage in the forming of sheet plastics into packages and indus trial components. It has grown from that time and an investment of $35,000 to become one of the leading plastics package manufacturers in in the country with assets of approximately $9,000,000. Sales are $18,000,000 a year and we employ about 450 people at plants in Kalamazoo; Hazleton, Pennsylvania; Somerville, New Jersey; El Segundo, California rinrl ^ O* The company entered into the FVC bottle producing business with th pur chase of the Tennepak Division of Tenneco in 1969 and the subsequent acquisition of Famco in 1973. Two of our plants (Somerville and El Segundo) with a combined employment of 11 8 are devoted exclusively tto the manufacture of PVC bottles. Furthermore, they represent approximately $3,000,000.00, or a third of our assets. Our company supplies between 5% and 10% of all the PVC bottles supplied in the country and our leading customers, to whom we supply more than 25% of their requirements, number 48. In some 10 cases we are the 100% source. B. Exposure Status; We have had our plants thoroughly reviewed by an established outside test ing concern. The results of these tests taken within the past few weeks indi cate that there are no operations or locations within our facilities that could meet the proposed zero ppm standard. We are, however, well within the 50 ppm current level and see no problem in retaining compliance to a 25 ppm level. Bor 0048qx impact of Proposed Standard: Of basic importance, it is our understanding that there is no possibility that any PVC manufacturer could produr u under the zero tolerance levels indicated, hence our total supply situation would be eliminated; we would be out of the bottle business. In spite of our diligent efforts over the past months to acquire materials re placements for PVC and/or variations of bottle business, this is not a viable situation since petrochemical supplies are in such short supply already that moving tonnage to the "EX" PVC bottle field is something that just can't be done. Logical choices of acrylic based materials, high density polyethylene and polyproplene are simply not available. Accordingly, the dismissal of our 118 employees would have to be immediate. The fallout to our customers in the absence of a minimum of 40,000,000 bottles per year could be even more traumatic since the replacement supply situation in glass, cans or paper bottles is likewise severely hampered by supply already. Of most significance to our company, it would have to be presumed that our banks would call their loans; we could not dispose of the unneeded bottle making equipment to a voided market and our whole company would be in jeopardy. D. Alternatives: It has been described above regarding alternate materials, the most obvious guiuuunj u* " ('"i *.j its <it. i3uu|ji ,.<< i i<< tv<> '. > < t, r.. Conversion of equipment to another use is likewise impossible; there are no other uses for plastic blow molding equipment. In short, we see no alternatives, nor have we had any explained. E. Summary Conclusion: Beyond the immediate fallout if the proposed standard is adopted of payroll terminations ("ME?); factory closings (2), and customer disorientation, we view the potential of this matter as nothing less than catastrophic for Fabri-Kal. We are privately held, we are not a division of any major corporation of any kind. We enjoy a record of growth and performance which is perhaps better than typical for the American free enterprise system. We feel that it is not proper from the scientific information and circumstances OSHA has utilized that wc should be administrated out of business. It is our firm opinion that the proposed standards are founded on incomplete informa tion and significantly jeopardize a major segment of the American economy. Proper steps can be taken to have VC exposure at safe and acceptable levels. They should be. A zero tolerance level is not required for safety or accept ability. The standard should be adjusted to the suggested plan of the *Socicty of the Plastics Industry. Fabri-Kal Corporation Kalamazoo, Michigan June 28, 1074 BOR 004802 OFFICE OF THE SECRETARY OF THE TREASURY WASHINGTON. D.C. 20220 \Z-- July 22, 1974 Dear Mr. Belli This is in response to Mr. Stender's letter of June 17 transmitting a copy of the OSHA draft environ mental impact statement on the Proposed Regulation Vinyl Chloride for comment. This Department has no comments on the statement. Mr. David R. Bell Office of Standards Development Department of Labor Room 500 1726 M Street, N.W. Washington, D. C. 20210 BOR 004803 UNITED STATES ATOMIC ENERGY COMMISSION WASHINGTON. O.C. 20345 jin. * Mr. David R. Bell Office of Standards Development Room 500 1726 M Street, N.W. Washington, D. C. 20210 Dear Mr. Bell: This is in response to Mr. John H. Stender's letter of June 17, 1974, inviting the U, S. Atomic Energy Commission to review and comment on the U. S. Department of Labor, Occupational Safety and Health Administration (OSHA), Draft Environmental Impact Statement entitled "Proposed Regulation - Vinyl Chloride," on the proposed action by OSHA to limit exposure of workers to vinyl chloride. We have reviewed the Statement and have determined that vinyl chloride is not being used in large quantities at any of the sites under the control of the AEC General Manager. However, at one of our sites, there is use of a liquid containing plasticized polyvinyl chloride, but air samplings taken in the vicinity of the operation have indicated vinyl chloride does not pose a significant hazard in this operation. The Statement in general is quite Informative and does serve as useful background to the proposed regulation, but additional information is needed. The animal data of Dr. Maltoni and Industrial Bio-Test provide the only quantitative dose-response data upon which to justify the concern regarding the 50 ppm exposure; however, there is inadequate detail presented as to the experimental design or the nature of the results. It would appear that sufficiently more detail of the experimental data should be presented to justify this or any other such concern that has such far reaching effects. Similarly, the discussion on alternatives (page 73) "to allow zero exposure" is superficial and also warrants considerably more discussion. BOR 004804 Mr. David R. Bell -2- The proposed work by the Environmental Protection Agency (EPA) should Include the assessment of the interaction of vinyl chloride exposure with other chemicals, such as HC1, Cl. and Hg salts, used in the manufacture of the monomer. This could also be expanded to include the many types of additives used during the manufacture of the polymer. In the discussion of the prospective work, the last two words of the phrase "the mutagenesis and teratogenesis of angiosarcomas" (line 12) appear to be a typographical error, and the meaning of "paralytic degradation of plastic" (line 13) is unclear. It is suggested that the impact of exposure upon lung, kidney, and brain malignancies may also warrant attention. Overall, we feel that more systematic and well-defined experimental needs and plans would be better met following a coordinated policy decision between the appropriate agencies, if vinyl chloride exposure standards are to be consistent with the potential released per annum. In this regard, we feel that a commitment to sponsor research and development on low-level vinyl chloride monitoring equipment, personal dosimeters, as well as continuous recording types, is needed. There are several aspects of concern with respect to the proposed regulation. The proposed standard, "no detectable level" is somewhat ambiguous since it is based on an analytical method which is sensitive to 1 ppm + 50% accuracy, but the detection method (sampling or analytical) is not specified nor described. There already appear to be even more sensitive methods available; it is not clear that industry can achieve the 1 ppm sensitivity level routinely. We suggest that the monitoring system for measuring the ambient levels of vinyl chloride involve the use of a continuous recorder with an alarm signal to detect out of range excursion. Finally, the precautionary measure of not employing females of child-bearing age or pregnant women should be noted. We appreciate the opportunity to comment on this Statement. Sincerely, W. H. Pennington Assessments and Coordination Officer Division of Biomedical and Environmental Research N cc: Council on Environmental Quality (5) BOR 004805 DEPARTMENT OF THE ARMY OFFICE OF THE SURGEON GENERAL WASHINGTON, O.C. S04I4 18 JUI / Mr. David R. Bell Office of Standards Development Room 500 1726 M Street, NW Washington, DC 20210 Dear Mr. Bell: The Draft Environmental Impact Statement, Proposed Regulation - Vinyl Chloride has been reviewed and the following consents are provided. a. The proposed standard limits employee exposure to no detectable level of vinyl chloride monomer when measured by an instrument capable of detecting 1 ppm + 50 per cent. Neither sampling nor analytical methods with this sensitivity and accuracy is addressed in the proposed standard or draft impact statement. Appendix C to the impact statement does refer to gas chromatography as being a common method for analysis, but a concentration of 2 ppm was given as the lower confidence limit. This is unacceptable. Recommend that preferred sampling and analytical methods be specified with the stipulation that other methods may be used if the accuracy and sensitivity meet the proposed standard requirements. b. Protective clothing, defined as "clothing protective against vinyl chloride," is required in regulated areas by the proposed standard to prevent dermal exposure to the chemical (Appendix B). However, Appendix C states that "vinyl chloride vapor or gas is not considered to be absorbed through the skin in sufficient amounts." Reconmend defining the need for protective clothing in light of above contradictions and, if required, specifying the type of clothing for particulate, liquid and gas exposures. c. The proposed standard requires that "waste materials be appro priately disposed of or decontaminated." Recommend specifying appropriate methods with the stipulation that equivalent quality alternative methods be permitted. \ BOR 004806 DASG-HCH-0 Mr. David R. Bell 1 JUL 1974 d. Medical surveillance requires numerous biochemical liver function tests including Garina Glustamyl Transpeptidase (GGTP). This test, reported to be a sensitive indicator of obstructive liver disease, is relatively new, not in common usage, and the sensitivity and specificity are'ill^defined. Recommend that this test not be included in standard until sufficient routine experience is obtained to establish quality control and confidence in the results. 1 Incl Memo US Dept, of Labor (wd incl) 2 BOR 004807 DASG-UCH-0 % 8 jin. 1974 Mr. David R. Dell Office of Standards Development Room 500 1726 li Street, 1,1-7 Washington, DC 20210 Dear Mr. Dell: The Draft Invironncntnl Impact Statement, Proponed PeculationVinyl Chloride has been reviewed and the following comments are provided. a. The proposed standard limits employee exposure to no detectable level of vinyl chloride! monomer when measured by an instrument capable of. detecting 1 ppm + 50 per cent, neither sampling nor analytical methods with this sensitivity and accuracy is addressed in the proposed standard or draft impact statement. Appcudix C to the impact ata foment does refer to gas chromatography as being a common method for ana lysis, but a concentration of 2 ppm ass given as the loser confidence Unit, This is unacceptable. Recommend that preferred sampling and analytical methods be specified with the stipulation that other methods may be used if the accuracy and sensitivity meet the proposed standard requirements. b. Protective clothing, defined as "clothing protective against vinyl chloride,'' ir. required in regulated areas by thn proposed standard Lo prevent dermal exposure to the chemical (Appendix il). llowever, Appendix C states that "vinyl chloride vapor or ga3 is not considered to be absorbed through the skin in sufficient amounts." Recoamiend defining the need for protective clothing in light of above contradictions and, if required, specifying the type of clothing lor particulate, liquid and gas exposures. c. The proposed standard requires that "waste materials be appro priately disposed of or decontaminated." Kecoiranend specifying appropriate methods with the stipulation that equivalent quality alternative methods be permitted. \ BOR 004808 iir. vta a. 1 8 JUL 1574 d. KwSicftl -urvoill: ,;..e re uir9 tvsaeroua biociiaBixo- 1 liver Xuoccxon tCi irtcl-iiu. i CX SSJ`> i.i ,,~../X *r->avyeptiu ,c i\*i,, tcec, rayortea by a ju -i'-iv a t-uiiccto? o.t li'/tr , i, ri L-.. fiv-aly .<>>. i-ot it y (,;, *nl Ui sensitivity muI upectiici iy -i`3 till tr- It '.i tilt !' tOt W iiT'jX it* It Tli UJUil i.-tk*i.c*sihk *`;a<.,.ay .-'-ivr-cacv i ovi;/:i.U la c-tt,i>lii.i %u--iily Cw'.tici * nj U0A:i;it^C4 iii u;e re.vlt . !>} nccreiy, 1 bb Jept* oi U.bcc C * ** ^ 2^ C iV Xi< , a i)> ijc;.t>aier Co.it't*!, iiii jjltctvor, iiM-ilUi Ct.*# Operation* 2 -v BOR 004809 Mr. David R. Bell -3- July 15, 1974 claim, (a. 4, 6l) that "700,000 workers_are exposed to vinyl chloride monomer1' is an estimate from the AFn-CxO, which plainly does not take Into account that all but a fraction of that number are engaged in operations which could not possibly result, in any exposure at all. This is a blind stab masquerading as fact. The critical facts are, as the hearing testimony clearly showed without meaningful rebuttal, that there is no way for the industry, with existing technology, to meet the standard proposed by 0SHA. The fact that many companies, including Union Carbide, are able to meet an employee exposure level for vinyl chloride mon omer lower than 50 parts per million does not mean that they can achieve levels below 25-30 parts per million and achieve a no detectable level. The companies are the only ones that have the facts on this phase of the problem, and are the only ones in any position to make this sort of assessment. They conclude, unanimously, as all have emphatically stated, achieving a no detectable level is simply not possible at the present time, even though they are all willing to make the attempt. Statements that the OSHA proposal can be met arise 'wholly out of ignorance or a self-serving desire to justify a position otherwise unsupportable. The allegation in the El Statement (p. 5) of "minimal economic impact," resulting from the standard proposed indeed, is wholly at variance with the statement admitting, in rhe very next sentence, that "some firms may incur substantial capital costs in meeting the requirements of the standard." The allegations on page 62-63 is so completely erroneous as to "readily available" technology that is is difficult to .see how they could have been made with any degree of confidence in their accur on the basis of a 5-plant walkaround alone. How substantial the compliance costs will be may bo judged from a survey of just one of the many Union Carbide polyvinyl chloride product lines that will have to be changed if the standard goes into effect as proposed. It will have cost the Corporation some $430,000 just to meet the requirements of the temporary emergency standard. To attempt even to meet the level of exposure in the pro posed permanent standard will require, it is estimated, an expenditure of some $12-14,000,000, without any assurance that the necessary results will be attainable in fact. The prospect of ttyis amount of expenditure for what may easily turn out to be a futility has BOR 004810 Mr. David R. Bell -4- July 15, 1974 led many companies to say they may well have to shut down rather than lace it. And the shove fimire was an estimate for only a portion of this Corporation's production of polyvinyl chloride resin. The most disturbing feature of this whole procedure is the type of thinking that it exhibits. This may be described as a willingness to plunge ahead with issuance of a proposal, regard less of the economic and social consequences, solely on the basis of fear-inspired assumptions that lack solid proof and whose major thrust is to place their targets on the defensive. American juris prudence has been founded on the principle that one who asserts a proposition has the burden of supporting it with proof. This wholly ealutory principle has been cast aside in this standard-making procedure. The proposed OSHA standard is promulgated as the answer to a possible, (^potential" in the language of the Statement), not a proven, or an actual hazard. Those affected are asked once the unsupported assertion is made, to undertake a massive effort to prove that a hazard does not exist in order to avoid costly, burden some, dangerous and wholly unnecessary regulation. The proof of the negative of a proposition, of course, is a legal impossibility in most cases, including this one, particularly where nothing of evidentiary support is offered for the positive of the proposition. This is a principle that the courts well recognize, and it is why they do not require indulgence in such absurdities, which they have repeatedly cited as untenable at law see Dry Color Mfrs. Ass'n. v. Labor Department (CCA 3, 1973), 486 Fed. 2d* $8. Certainly, OSHA should recognize the force of such Judicial logic is valid after its previous experiences in the courts, and should proceed to set standards based, as the statute requires on substantial evidence on the record as a whole. Yet, despite its past record, OSHA has apparently headed down the same road as before, of making non-factual and conclusionary assertions which almost seem to invite court action. This vinyl chloride monomer environmental impact statement is no exception; its conclusions have already been rendered nugatory by the hearing record. BOR 004811 Mr. David R. Bell -5- July 15. 197^ What OSHA should have concluded; what the hearing record shows; and what OSIIA could validly have previously ascertained for itself had it (or NIOSH) been willing to listen; is that the . environmental impact ol' the proposed regulation of vinyl chloride monomer stemming from the severe economic impact of the regulation would he substantial; but, on the other hand, (as EPA has already concluded) the environmental impact of current vinyl chloride mono mer permissible limits was negligible, indeed, not even discernab.1 e; and that no environmental considerations whatsoever would dictate any vinyl chloride monomer regulation, even at the level of the current OSHA emergency standard. The actual economic disaster the permanent standard proposal portends is hardly Justified by the minimal number of individuals that could potentially (not actually) benefit. The evidence OSHA possesses merely shows that a statistically insignificant number of employees, exposed continuously for prolonged periods of time to high vinyl chloride monomer concentration, could possibly get angiosarcoma; even that result is not a proven certainty. The evidence showed nothing else, nor will a review of the OSHA and NIOSH presentations at the hearing show any warrant for any such stringent regulations as is proposed. If there is truly a hazard, even from unregulated vinyl chloride monomer exposures, it at best is slight; limited to a workplace producing or making vinyl chloride monomer and, indeed, to a very few areas in any such workplace, with out any impact on the environment outside; and a hazard in the workplac< only at continuous exposure levels far beyond those OSHA limits either in effect at any time or proposed. OSHA's findings should also include a statement that there will be a severe environmental impact resulting from the economic consequences of adopting the proposed standard, wholly unwarranted by the hazard sought to be met, and which ought not to be imposed either on employers; on the employees affected by Job loss; or on the consumers who use vinyl chloride monomer-related products in many harmless forms. S BOR 004812 Mr. David R. Bell 6- - July 15, 1974 I urge that such a conclusion is far more warranted even under OSHA's own factual assertions that the ones reached in.fact, and that OSHA should substitute such conclusions for those in the statements. If not, the only alternative would appear to-be a com plete rejection of the statement, and its Issuance in revised form, as above recommended. V^ry truly yours. JWW :me / c7 C <: - v* c i-'({ ., John W. Whittlesey BOR 004813 MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WR.l ARl PUBLIC HEALTH SERVICE CENTER FOR DISFASK CONTROL NATIONAL INSTITUTE FOR OCCUPATIONAL SAFKIY ANI) III Al III To : David R. Bell Office of Standards Development, OSHA DATE: July 16, 1974 > FROM : Director, Office of Research and Standards Development SUBJECT: Draft Environmental Impact Statement - Vinyl Chloride As requested in Mr. Stender's memorandum of June 17, the following comments concerning the Draft Environmental Impact Statement on Vinyl Chloride are offered. There are a compilation of a number of reviews made by NIOSIl professional staff and serves as the official NIOSH response to the draft statement. Page 1 Delete the term research arm of OSHA and replace with Center for Disease Control. U.S. Department of Health, Education, and Welfare. Page 3 You may wish to modify the final paragraph of the Background section to note that both foreign and U.S. animal studies have induced tumors at 50 ppm. The last sentence concerning protective respiratory devices should identify such items as interim measures until engineering controls can be implemented. Page 4 The statement that health effects resulting from Vinyl Chloride probably have a long latency period is somewhat misleading. The effects do have a long latency period, notably 20 years (average) for the development of angiosarcoma of the liver. It is stated that the proposed standards "deals with the disposition of waste materials." A review of the standard does not disclose any meaningful coverage of this subject. This should be deleted or clarified at a minimum. BOR 004814 Page 2 - Mr. David Bell Page 22 The last sentence discussing migration of VC to the surface of PVC docs not make sense. In that the VC can, under certain conditions, migrate to the surface of the PVC resin and subsequently be released, does this not constitute a potential worker exposure? It would seem that the intent of the standard should be to control VC in the workplace no matter what the source of exposure. Page 57 It is stated that the proposed standard requires adequate venting of reactor vessels before worker entry. This is also stated in the preamble to the standard but cannot be found in the standard itself. Aside from that point, it should be made clear that ventilation is also necessary during cleaning/repair operations. Pages 63-65 Starting on p. 63, we question the extent to which OSHA has demonstrated that "technology appears to be readily available" for engineering controls.We certainly don't have the data to support such a strong statement. Control techniques, including ventilation may not be too difficult for VC production which is Intended to be a closed process in the open. Ventilation of process vessels for maintenance should also be straight forward, although we don't have sufficient data to establish the effectiveness of air cleaning devices in removal of VC from exhaust air. In producing PVC, particularly with respect to the compounding operations including mixing, ahd in the fabrication of end products from PVC including calendering very specific control systems would be needed to achieve the no detectable level. In general, the broad statement on p. 63 appears too unsubstantiated and should be at least modified to more accurately reflect the state-of-theart. Unfortunately, the state-of-the-art for engineering control techniques for vinyl chloride has not in our opinion really been established and this BOR 004815 i ................ #. r, fitolrtch mratesil Comp*u * 11i i 11 i * * ** ** IIHI DM Tlt (DUMVDDD ' CLtMlADD. 0 0 4 4 t i I * ` P * f J f t > T 1 viMOh! OVIKIDIt fltlftMil July lb* i9& Hr. t-.viJ U. Hell Office of Standard* Developi^ot Roots 7 CVJ 1726 H Street ?. T*\ t'oshiMtort, D. C. TC-10 U=*Ar Mir. IkE.il: Pursuant co tne Kut- .'candum dated Juue 17, ! 97-^ from Jehu h Stendst. AteiSf.-tnt Secret cry f-f Labor, v have the fallowing Cc:=c,':-tiLS l'i ,*3j:di -;! the thrift Envii; ;. e.ui itriict (DLIS) on Pr^po^cd RcriO eti'Hi Vinyl Gnlorio:;. MIS ir. a *ort by a msmbOr of iK?orlo L:* tc the;-selvas, quickly to vary o. ; -isx problem chrcvgt, readily uViiiiablo publications and a -a Ik thmu.'V. .-. .i ^ey uf eevea ylf.utfi located in tUQ Southern part of the United Ste: . Use c*.`i;v:Iu.itir.3 t;v,r;. Ippen i" C .'r," the tu >eh so elfv'i'i. by both he iiucv*'y r.roup iu r.-; f he 1713 r. r.plied to th* 7.5 '.rji'CTsas pis-nta (aoeniy Su'j'J'Cia an-2 uveu lc ^T..iona) aoO niio 36 polyrser plants ^r,o=r?y bnttht 'r; ind closed r.;t itisa to be unsupported,. y- note a n;rL-,tT o/ inatci-xcci^e in cey-ei't publi&Ued loloTnisticr.i, but, since v? understand chi; BE IS ill bs eeuo:;i' ' ukiuy into ccowldexoil ini0; > priori presented -1; the rec-nt rieariug. vk will conaettit c-> unly e rerro' c. It apu*arc that the Pr' I I-' bes-ij uo ten _.!: itCSuaptlons which Si *' .-.i surp*-,ri >vd by fact, ,* y: 1. That the };rop:.::u'j ' * iter-- -'t itae-isru . oxpo;-.`.ra to Vo'- - ^P serf to ? re (i etOctable l*':v&i of ll'V** !. Of ) p,""- 2. That f: 17. te e:' . 1C' ' ;! * '.hy c ry/ ' > ! ;:;p.uu Ln - i t;rate VCii a-.,3 7VC rl-,..-n .-. .. v, v r ; i ; . . uf. L, : i ' 1 t! l.l rii * Cr.-,i i is :- , vitiW:. 7-.U.U `.ntlv.v.-i, , I ;.-r r - : * t * s ; ..t; "* b2ft it-1 op--vnto v.ith ver'nr. s in eri t en it - "ilr FV!]V : i ; -J ri^sk ."*,vi wlKsic-hody air fiuppjiifi Busts. BOR 004816 TJae possibility of engineering nr re-engineering to raeet the proposed standard is discussed oq pegs 62. There is no data offered to aupFort technological feasibility, except to say that "costs could be vtr> Substantial". Also, thnre is recognition that the use of "required personal protective equipr^nt sy reduce the productivity of a varher through reduced fobility", but again, no eorasrt ns to the discomfort and health cod rafety hasrrds to tho individual through such use, OSHA Industrial Hygienists conducted an on-site survey in March, 1974 (Appendix c) of five vinyl chloride manufacturing facllltlos end two FVC plants in the Baton Roy?,e-Nc Orleans area. From this survey, the following conclusions were drjnsn: '**2. The PFC manufacturers have a more serious problem of VCW 'xposur*: then tl.o VOH producers because most of the polymer ization process :'juipr;enL ie in enclosed areas and ventilation is insde-'VJrt-:-. "3 kr> ft or. t-Jr2 process S'leipixect. vessel entry, VOX tank car t::! 'r'biV..u., EP process p]lup, .WC reactor clcar.irg, cnrspuundir.c aaO pneksgiug areas are major pOUPutlal sources of ''CM c7rs`*ro found dvrir.g this survey. "4, njin&erirvi t^chnulor:v fur Control of VCM exposure is available ;i hss iS'S j.'sf'Iaoautod by ii-idustry. "5. obscEvc> practices relative to equipiastit maintenance, crnitcrinr:, r::^lccl crcrdnsl-ioEs and surveillance end training Ate CC:vii.`-ii : ;'i Lo be Inadequate to COIitrol the i irnloycd* p-rp&!iari to VC".''." bn .:;'*itrr;JicLio-a to thus-:- conclusions, .the *>E2,S (page CuO rtnts- "Since Uif. tccbr.ulo"'" &yp'?~r; tc- be readily uvail~"-Ie, it- can be as'ivrcd that substansial Jevf.'otii/v.t costs will aot fca incurred." t v-.T. the ce.um.t: d.j;.a quoted on the two ol cpvnn piaaha visited (both o!.-j if?utIy x'{~bi rssn- 'a;. Curing iu:ilitiiOu) dificloSod Only ct_P ooili>>)': vaiue '.:visv 1 ppm, Kut *. date Tuporfed .>. on k Tins Weighted Avur.-ge ba.ai.-i \u.je rerenusub i.Ti f.3. ; propeu-ou PfEndars) , ;;nn l) shewed detectable i~,. .V'E*..,C<< i, l>:, `ih'Lw <jat^ uertoinlv : r n p.!;-..: n.-vrjr.Sm, at;;- d poauru %'Wf* t pxr;t: of 3 50 i'*rr-'} v iux ur-ei to t uppart the luuu i Mi;,t y of rh: pro. Jr tubiiticn, thin dutu shywe. ui gaif bcant -p- x^x-yepey Brarid.xru (several r=Acinus ivs CdecSaS The DEIS (pap.;* t-3) \jr*.i r.io-tti several possible er*'jaa of improver*-nL which w^uld lead to j,.ru-,xr , .x.ru.urc lc-'cin. b*hilu v;; re.-xcgnizw t.het these Buf:;eas. iwnb r-ay ui-. , they ice ot uom i-finv sifecLivuly Icol*-':T&uted, reduce irj-'CMUo, v,-.; fi.T-' ot nu wry to touuev ernosurfe Co 1 ppri or nodeLtctobJc level. .tcovurt VC L-..,ov o no other fvC or VC r>lfiut v'uicit lr. oper.itinj.: or can operate within the proposed permanent standard. ' BOR 004817 3 In Bursary, there are no data in Appendix 0 that could logically lead to the conclusion that o ceiling or 1 ppn is feasible in vorV areas of existing facilities even with engineering codifications. Therefore, we find that there i* absolutely no substantial basis, either in the DEIS or in fact, fur the statersnt on page 6": "Vo evidence to date indicates that promulgation of the proposed litaudard viii etoy vinyl chloride pu - .cticn ot;J. cifc, vvh production in sou: plants could to curtailed if re-cnr.tnccrtnp, is required. " Tu the contrary - the evidence reinforces the industry position th^.L it ccrn^t r-:r, nor ir rh~ fi-reaecsble future, eairply with a vci3ia cfciiir';; level oj. 1 ppvi UH in c-itnor its VCfi or JVC tisnuiactorir, t^cil iti.es,. Cartridge respirators are fiixrrsariiy dismissed (p-56) wit.nout provision for future ir. proven at or recognition -?f their wffactivenfchfi under appropriate operating cyndit.iu.nfc. Theta ia no recognition of the personal problems irrvnlved in wearing 11full face respirators*', nor "whole-body air Supplied Suits i2p,-*rvjOuS to vinyl chloride". The fitetenfir/- the inclusion (prgs 33) of a specific protocol fo; testing, nfidical diagnouia and trCatntCi't for a ufcvly identified disease for which thorn i.-: t;o /iiovii predictive terming. There are a nua.l-.~r of technical inaccuracies. For RTfinple: 1, Production cf nyl chloride Table 1 ra%e 2fc Shell's testimony at the February 15, 1974 hearings is referenced SS source oi their viuyl chloride vjtmoivBT capacity. The reported figures of 1,200 and i,GQG Trillions of pounds (per yesr?) ere actually 51 a ted in fha testimony cfc 1200 and 1000 tons per day, respectively, for their tvo plants. This way explain vhv, On page 2li, tue authors vure vuiazicd by the anpcrtint discrepancy in the r.urjhcr ci workers rep-.'Ctod fcy i'FU end Shell required -- "per rtiliou too.1;11 -* (oi vhat 2. Proilucvtstz, on of vinvl chloride pulvw^r and coiolinger reeinft_ r BOR 004818  -4- Are OSHA and ocher Govermaental agencies cognizant that over 507. of vinyl Chloride (*u<J i-VC) Is derived /r.ju of vhjch the vorXd has a super abundance. likewise, tea percent ot the chlorine produced In the United Stores i used to IT-Ice FVC and a reduction of caustic production would have * significant environmental Jnpact. la .t-.- t in our v-' ft, the proponed petrsuwat standard is not technically fcutlble and the DEIS provides no evidence to til contrary. V"ur!5 very truly, B.F.GGOD&XCB CHEMICAL COHPA'tt s Division of The S,F.Goodrich Company AV/je > Auton Vittone Division President BOR 0048X9 DOW CHEMICAL U.S.A. <r July 16, 1974 POST OFFICE BOX 1706 MIDLAND, MICHIGAN 48640 Mr. David R. Bell Office of Standards Development Room 500 1726 M Street, N.W. Washington, D. C. 20010 DRAFT ENVIRONMENTAL IMPACT STATEMENT ON PROPOSED REGULATION OF VINYL CHLORIDE Dear Mr. Bell: OSHA is certainly faced with a most complex and difficult area of decision making in establishing a new occupational health standard for vinyl chloride. Preparation of an adequate environmental impact statement is thus a compounded difficulty. Even so, the draft environmental impact state ment is a gross over-simplification of a most complex ar a of technology and decision making. Extensive data were sub mitted at the June and July public hearing on the Propos d Standard for Vinyl Chloride. We sincerely suggest that the final environmental impact statement represent a more balanced perspective of the new data presented in these hearings. We have several suggestions relating to the gaps in data and in quantification of judgments in assessing risk and technical feasibility. We also feel that the consideration of alter native standards needs more reasoned judgment of benefit/risk considerations, weighing of technical feasibility, and articulation of the risk for each alternative. A. Gaps in Data and Quantification of Judgment Hazards of Vinyl Chloride and TVC - The data cited to illustrate the hazard of vinyl chloride are the results of animal experiments and the known cases of angiosarcoma of the liver which have been associated with only certain plants producing vinyl chloride and PVC. Most other re ports of adverse effects have been associated with operations where exposures are acknowledged to have been very high in the thousands ppm range. The data from the. TabershawCooper epidemiological study of the total industry, although available in early May, 1974 are not cited. AN OPERATING UNIT OF THE DOW CHEMICAL COMPANv r - 4" you vv'. BOR 004820 Mr. Bell 2- July 16, 1974 We also note that considerable data have been presented in the June/July public hearing indicating that a number of plants have been operating in a manner that has re sulted in no known cases of angiosarcoma of the .liver. We believe that a careful judgmental weighing of the epidemiological data must be made in establishing a standard. We base our conclusion on the hearing record which indicates that test animals, particularly mice, are more susceptible to diseases caused by vinyl chloride exposure than are humans. It may be worthy of note that in Professor Maltoni's studies the rats that developed angiosarcoma of the liver and elsewhere (at 50 ppm) were 135 weeks on the experiment - or about 148 weeks old. This equates to a human well over 100 years old. Data on metabolism of vinyl chloride in the rat is also relevant to the decision making because it suggests a reasonable explanation for a dose-response relationship. Occupational Exposure to Vinyl Chloride - The EIS indicates that at present "a reliable model designed to predict the expected number of cases" of angiosarcoma cannot be formu lated. With this statement, the assessment of health hazards is dismissed in the EIS. The statement implies that judgments of hazard will have to be made. We concur. It therefore seems that the EIS should reflect at least semi-quantitative estimates of risk at various exposure levels. We suggest that the final EIS reflect more accurately the trend in exposure levels that has occurred during the last twenty years. Semi-quantitative data on the trend of decreased exposure have been presented in the public hearing. To us, this trend seems highly relevant to the assessment of the degree of hazard faced by workers today compared to the hazards of approximately 20 years ago. The Proposed No-Detectable Level of Exposure - The EIS attempts, by strong inference, to imply that assignment of the level of exposure in the proposed standard is not a judgmental decision. The level of exposure selected in the proposed standard, no detectable level, as determined by a sampling and analytical method capable of detecting vinyl chloride at concentrations of 1 ppm with an accuracy of + 50 percent, is cited as the recommendation of NIOSH. Presumably, this recommendation was based on a judgmental assessment of the feasibility of analytical methodology. Further, to decide that the limit of analytical method feasibility will provide a reasonably safe workplace is another judgmental decision. We strongly believe, as -- BOR 004821 Mr. Bell -3- July 16, 1974 will be cited in part B of this communication, that there are better criteria of judgment for permissible exposure levels. The proposed standard "is intended to assure, so far as possible, a safe and healthful work environment." It seems to us that judgments should be made of the possible benefits and risks of the other alternatives, like zero exposure, the ETS, and some intermediate level(s) of environmental concentration. These will be difficult judgments, but certainly experience of plants at estimated environmental concentrations over 20 to 30 years of oper ating experience are now available to OSHA. Probable Impact of the Proposed Standard - The impact of the adverse consequences of the proposed standard seems to be grossly over-simplified. Recent news reports indi cate that compliance with the ETS is already decreasing productivity in the PVC industry; rated capacities hav been decreased by as much as 7 to 25% (Chem. Mktg. Reporter July 1, 1974). The statements in the EIS relating to "small increase in costs" and "ability to absorb such costs is in stark contrast to the preponderance of testimony presented in the public hearing. Substitution of other materials, wood, metal, or rubber, for polyvinyl chloride seems to be projected with undue optimism. Replacement of a five billion pound product simply cannot occur over night. Potential substitutes for relatively simple applications are already in short supply and it is questionable whether cited substitutes would meet product engineering property specifications testing for performance frequently takes 1, 2, or more years. If substitute materials are to be considered as part of the decision making, it seems only reasonable that their technical feasibility be documented. Also, the avail ability o fabricating equipment and the time to develop and produce it are among the practical problems associated with any switch in basic materials. The assertion is made that some substitute materials would be less consumptive of irreplaceable natural resources. This should be viewed in the context that U.S. PVC pro duction consumes hydrocarbons equivalent to only about 0.4% of U.S. gasoline consumption. Further, whereas potential plastic substitutes for PVC are essentially hydro carbon in origin, more than half of PVC derives from com mon salt. bor 004822 Mr. Bell -4- July 16, 1974 The impact of decreased commercial availability of caustic (sodium hydroxide) has not been considered in the EIS. Approximately twenty percent of U.S. chlorine production is utilized in manufacture of vinyl chloride. Caustic is a co-product in chlorine production. Shut down of PVC manufacture would result in loss of 20% of the U.S. caustic supply. Caustic is already in tight supply. Any decrease in caustic production will decrease pulp and paper and aluminum production and seriously threaten production levels of a larger number of essentials, such as soaps and detergents, petroleum refining, waste and water treatment, and food processing. Technical Feasibility - The courts have recently held that occupational health standards must meet certain tests of technical feasibility. The EIS contains several references to the technical feasibility of various engineering controls and other production techniques. These appear to be qualitative appraisals and often suppositions, with no cited basis for evaluation of their validity. In contrast,, the June/July public hearing record is filled with numerous references to lack of technical feasibility to meet the proposed standard. We feel that the discrepancies between the EIS statements and the public hearing statements must be resolved in the decision making. We note that EPA has recently developed a definition of "available technology" as follows: 1. Technology which has been demonstrated and is currently known to be feasible. 2. Technology for which there will be a production capacity to produce the esti mated number of parts required in reasonable time to allow for distribution and instal lation prior to the effective date of the regulation. 3. Technology that is compatable with all safety regulations and takes into account operational considerations, including maintenance, and other pollution control equipment. (Federal Register, 39, No. 129, page 24580, July 3, 1974). 004823 BOR Mr. Bell -5 July 16, 1974 Although this definition was developed in conjunction with proposed establishment of noise emission standards for railroad equipment, it's reasonableness and simplicity appear applicable to the present decision making. It seems to embrace the concept of technical feasibility. We urge that the EIS reflect objective evaluation of various proposals against the criteria enumerated above. B. The Weighing of Alternative Standards - We strongly urge adopting of a more reasoned judgment of benefit/risk considerations, the weighing of technical feasibility, and the articulation of risk in evaluating the various alternative standards that might be promulgated by OSHA. The alternative of "allowing zero exposure" which literally permits no exposure, is presented rather superficially. In reality, this is not a practical alternative. It is essentially the same as a ban. Dow supports reduction of the ETS to levels which can b reasonably attained within the limits of technical feasibility. However, to state that the ETS is inadequate because of the animal data, without giving an assessment of how this equates to 20 to 35 years of industrial ex perience, seems an over-simplification. The alternative of relying on personal protective equip ment is dismissed on the basis of not meeting the test of acceptability under OSHA. We believe the record should show that such an alternative would have highly und sirable features and hazards as cited in the testimony at the public hearing. This seems most important since many believe that the proposed standard would, in reality, necessitate the continual wearing of respirators and other protective equipment by a large percentage of the vinyl chloride workers. These comments do not imply that appropriate protective equipment should not be used for certain jobs of short duration or emergency situations. We strongly maintain that the alternative of setting a limit between one and 50 ppm vinyl chloride has been dis missed capriciously. This alternative was summarily dis missed on the basis that "the selection of a permissible level between 1 and 50 ppm would be judgmental\" As indicated earlier, the proposed standard is based on a judgmental decision - that the feasible limit pf detection equates to a reasonably safe workplace level. To select one alternative on a judgmental basis and to reject another alternative strictly on the basis that it would be judgmental is . incongruous. BOR 004824 Mr. Bell -6 July 16/ 1974 Dow, and others,-presented factual data at the June/July public hearing showing that operations on the leading edge of technology generally maintain 8-hour time weighted average environmental concentrations of approximarely 10 ppm with short-term concentrations in excess of this value. Epidemiological data are also now available (hearing record) to evaluate the health effects of such operations. We urge that any environmental impact statement should reflect decision making based upon carefully weighted judgments of technical feasibility, risk to workers, and the societal benefits of vinyl chloride. Sincerely, / Fred Hoerger, Ph.D. Operations Manager Health and Environmental Research cc: Council on Environmental Quality (5) Dr. V. K. Rowe, Dow D. A. Rausch, Dow Pi t N BOR 004825 Cities Service Company box wo TULSA, OKLAHOMA 74101 July 16, 1974 Mr. David R. Bell Office of Standards Development, Room 500 Occupational Safety and Health Administration U. S. Department of Labor 1726 M Street, N. W. Washington, D. C. 20210 Dear Mr. Bell: Cities Service Company is a large diversified company primarily engaged in petroleum, petrochemicals, gas, copper, industrial chemicals and plastics. One of the facets of Cities Service is Chester Cable Opera tions, a relatively small fabricating facility that uses polyvinyl chloride in insulating wire and cable. Cities Service does not produce vinyl chloride or polyvinyl chloride. Testimony has been presented by Cities Service at the hearing convened on June 25 to receive comments on the prepared vinyl chloride standard. We perceive a tone of retrospective condemnation in the draft state ment, for example, on Page 2: "Vinyl chloride has been used in this country for over 30 years with little concern for health problems .. . ". A more ac curate description would have been that vinyl chloride exposure was controlled according to the hazard potential described by the information available at the time. This is true of other substances as well, whether they are very hazardous radioactive isotopes or innocuous peanut hulls. Tf ........... .' views and arguments presented at the proposed vinyl chloride standard be considered in developing the final environmental impact statement. It is patently clear the draft state ment grossly underestimates the effect the proposed "no detectable level" would have. This underestimation is partly due to the misinterpretation that "no BOR 004826 i Mr. David R. Bell Page Two July 16, 1974 detectable level" means 1 ppm. The proposed standard only specifies the accuracy of the measuring technique at the 1 ppm level. There is no sensi tivity or lower detectable limit specified. Neither is a specific sampling and analytical technique required, allowing considerable variation in sensi tivity. Our own sample collection and analytical technique was given'in testimony at the hearing. This method measures accurately within the +^50% limits at 1 ppm but can detect vinyl chloride below 0. 1 ppm, and the detection limit can probably be extended another order of magnitude. Without specifying the lower detectable limit or sensitivity required or the precise details of one selected sample collection and analytical technique, the "no detectable level" is that detected by the best method available in the technical world. Unless other wise stated, the regulated must assume the regulator could have the best possible method at his disposal. Techniques used by a large research laboratory are not necessarily feasible for a small PVC fabricating plant. If the proposed standard intended to set an exposure limit of 1 ppm, 8-hour time weighted average, that could have been simply stated. In estimating the probable impact of the proposed vinyl chloride standard, the draft statement refers to low levels of exposure in many operations under normal operating conditions and favoring engineering controls, for example, Pages 55 and 62. The proposed standard is not a recommendation of guide lines for good practice -- it is a recommendation of law. The proposed standard clearly requires, not favors, engineering and work practice controls. The requirement is categorical and not limited to normal operations. Definitive results are currently not available to accurately describe the carcinogenic mechanism in man, define a precise no-effect level in man or animals, or identify an animal species that responds similarly to man. In spite of this, the draft statement draws on the Bio-Test Laboratory results using mice exposed to 50 ppm as more significant than the lack of angiosarcoma in rats and hampsters exposed under the same conditions. All data available must be considered in developing a vinyl chloride standard and estimating the possible environmental impact. We strongly recommend a thorough objective evaluation of all data, views and arguments available, including the testimony provided at the hearing convened on June 25 and reconvened July 8. From testimony to date it is clear the v^nyl chloride and PVC industry could not continue to,operate under a "no detectable level" BOR 004827 Mr. David R. Bell Page Three July 16, 1974 tandard. This environmental impact is significantly greater than, "additional capital and other operating costs". We have reviewed the Draft Environmental Impact Statement on the Proposed Vinyl Chloride Regulation. It is difficult to make specific comments on each of the sections and paragraphs of the draft statement. This is due to misinterpretation of the specific language of the proposed standard used in forming conclusions presented in the draft environmental impact statement. The imbroglio created does not encourage constructive recommendations. Sincerely, CITIES SERVICE COMPANY ELrS:jb JWSjsw Everett L. Smith Manager, Safety St Training N BOR 004828 7 somvwn i. imn an.f uarifWi eauiJi m msskax WILLIAM X. SOMBniRI, JR ROBERT R. TIKKXAX WAYX* V BLACK DAVID X.. IUIX MARTI* 'w. BKMCOVIC1 rnwnr. imvAci nrrxR m. jtkmkov JOSEPH 1. HADLET CAROLE C. HARRIS WILLIAM W. PUOH LAW OPflCKS Kelleh and Heckman uso inr itKiiT, v. v. rutk tooo WA5HINOTON, D- C- 20036 July 17, 1974 TGUniONE 80S Mfl'SIOO CARLS ADDRESS "WUCIK" Mr. David R. Bell Office of Standards Development Occupational Safety and Health Administration U.S. Department of Labor Room 500 1726 M Street, N.W. Washington, D. C. 20210 Ke: Draft Environmental Impact Statement on Proposed Action to Limit Exposure of Workers to Vinyl Chloride Dear Mr. Bell: Responsive to Assistant Secretary John H. Stender's June 17, 1974 "Memorandum for Recipients of the Draft En vironmental Impact Statement on Proposed Regulation--Vinyl Chloride", the following Comments are hereby submitted to the Office of Standards Development of the Occupational Safety and Health Administration (0SHA) on behalf of our client, The Society of the Plastics Industry, Inc. (SPI) and its Vinyl Chloride and Polyvinyl Chloride Resin Pro ducers Committee. 1/ 1/ The Society of the Plastics Industry, Inc. (SPI) is a Corporation organized under the Not-For-Profit Corporation Law of the State of New York. It is composed of approxi mately 1400 member companies and individuals who supply raw materials; process or manufacture plastics or plastics products, engineer or construct molds or similar accessory equipment for the plastics industry; and engage in the manufacture of machinery used to make plastics products or materials of all types. SPI is the major national trade association of the plastics industry, its membership being responsible for an estimated.75^ of the total dollar volume of sales of plastics in this country. A more complete (cont'd) BOR 004829 2 It should be noted at the outset that the following Comments are being submitted for your consideration with full recognition of the fact that Dr. Daniel P. Boyd, Direc tor of the Office of Standards Development, clearly stated on the record at the recent OSHA Hearings on the proposed permanent standard for occupational exposure to vinyl chloride that, to the extent any interested party testified regarding the proposed permanent standard, such testimony will be considered as that party's comments on the Draft Environmental Impact Statement referenced above. 2/ In light of Dr. Boyd's statement, in the following paragraphs we have simply summarized the basic SPI positions on the proposed standard and are requesting that the views ex pressed be considered along with the entire record as a statement of SPI's Comments on the Draft Environmental Impact Statement. I. STATEMENT OF POSITION 1. The positions of the Society and the members of its Vinyl Chloride and Polyvinyl Chloride Resin Pro ducers Committee on the technological feasibility and economic impact issues relative to the proposed standard were presented in depth at the recently concluded OSHA Hearings, and, in our view, stand generally uncontroverted by factual evidence. We respectfully submit that a "no detectable" level of vinyl chloride in the workplace is (a) infeasible, (b) unwarranted, and (c) therefore, beyond the intent and scope of the Occupational Safety and Health Act and the case law developed to date. 2. More specifically, SPI and many other parties participating in the referenced Hearing repeatedly pro vided hard data showing that the proposed "no detectable" level of vinyl chloride is technologically infeasible to 17 (cont1d) discussion of the interest of the Society in this entire matter is set forth in the Occupational Safety and Health Administration Hearings, In the Matter Of: PROPOSED PERMANENT STANDARD FOR OCCUPATIONAL EXPOSURE TO VINYL CHLORIDE, Transcript at 330 ct seg. , June 26, 1974. (Hereinafter cited as: Transcript at ______ , (date) .). 2/ Transcript at 1110, 1111, July 8, 1974. BOR 004830 achieve because the vinyl chloride monomer and polyvinyl chloride producers, in the present state of the art, can not completely eliminate vinyl chloride exposure in their manufacturing operations. This most vital element of the Society's position was not countered by even a scintilla of evidence showing that a "no detectable" exposure limita tion is technologically feasible. Furthermore, no evidence was adduced at the Hearings that would controvert the Society's position that the imposition of an infeasible exposure level would result in a shut-down of the vinyl chloride and polyvinyl chloride industries. 3. It is also SPI's position with respect to the proposed standard that the medical and scientific evidence alleged as the basis for proposing the complete insulation of the work force from minimal vinyl chloride exposure is not sufficient to warrant the conclusion that more reason able exposure limitations would cause an undue hazard to employees. The Society's view is that the toxicity of vinyl chloride does justify limiting exposure levels but that the industry's alternative proposals to a "non-detectable" level give reasonable assurance that any hazard will be reasonably delimited and that employees will be protected from exposure to dangerous levels of vinyl chloride in the breathing zone. 4. Furthermore, medical experts testifying on behalf of the Society and others urged that the human experience data assembled is entitled, on toxicological grounds, to far greater weight than the inconclusive animal test data presented. Additionally, the human ex perience data justifies those exposure limitations which the industry considers feasible now and in the future. Considering all the testimony given at the Hearings, it is submitted that the tenor of the composite medical opinion was that the human experience data indicates that human toxicity problems associated with vinyl chloride stem from a time period when occupational exposure to vinyl chloride was at a considerably higher level than currently exists under the Emergency Temporary Standard. II. COMMENTS ON THE DRAFT ENVIRONMENTAL _________ IMPACT STATEMENT 5. OSHA's Draft Environmental Impact Statement is premised on the finalization of the current proposal without BOR 004831 4 change, the conclusion that the proposed standard is technologically feasible, and a presumption that the animal toxicology data mitigates against human exposure at levels above "non-dctectable". SP1 takes exception to these general propositions and urges that they be revised in the final Environmental Impact Statement insofar as evidence adduced during the Hearing and otherwise con tained in the record illustrates that these premises are invalid. 6. With regard to the outline of the proposed standard at Pages 53-60 in the Draft Environmental Impact Statement, the Society's specific comments on the details of the proposed standard are a matter of record and can be found in the transcript of the Hearing. 3/ 7. The Society, herein addressing the Draft En vironmental Impact Statement rather than the proposed standard, takes strong exception, as enumerated below, to the sections in the Draft Environmental Impact Statement dealing with: "VI. Probable Impact of the Proposed Standard" at Pages 60-65 and "VIII. Alternatives" at Pages 8. The Probable Impact section begins with the conclusion that adoption of the proposed standard will result in a workplace free of vinyl chloride exposure and result in less vinyl chloride escaping into the ambient air. It is stated also that compliance costs will threaten marginal firms, raise the price for PVC, and encourage the substitution of other materials but that high reliance on PVC will reduce demand elasticity despite these price changes. The Draft likewise postulates that other costs associated with compliance are deemed capable of internal ization. 9. While understanding that the Draft Environmental Impact Statement was prepared prior to .the conduct of the above-referenced Hearings and that the evidence adduced at those Hearings consolidated considerable background and expertise upon which OSHA's ultimate decision will be reached, the Society is compelled to note that, in its view, the Draft Statement itself offers no documentation \ 3/ Transcript at 300-685, June 26-27, 1974 (and elsewhere throughout the record). BOR 004832 or supporting evidence for the conclusions reached. In fact, it is respectfully submitted that the evidence gathered through the hearing process just completed in dicates that it is technologically infeasible to achieve the proposed "no detectable" level of exposure in the workplace, that this technological infeasibility is not primarily economically related, and that substitutes fOr PVC are not in adequate supply. 4/ 10. At Page 62 in the Draft Statement it is in dicated that the proposed standard favors engineering and work practice methods that would reduce the exposure level and, at Page 64 and elsewhere, it is indicated that these engineering and work practice methods should include im proved ventilation, air filtration, and housekeeping. Testimony at the Hearing indicates that engineering and work practice methods could reduce but not eliminate ex posure to vinyl chloride in the workplace. It is submitted that the record is replete with information on these points and that such should be reviewed in great detail prior to the finalization of this Statement so that the environmental analysis will be based on a more accurate assessment of the state of the technology. 11. On the same page the Draft addresses supply problems, specifically with regard to personal protective equipment, that should be expected to occur with the im plementation of a regulation such as is now proposed. Supply shortages, and lead-time for ordering and instal ling various types of equipment to reduce vinyl chloride concentrations in the workplace were addressed at length throughout the course of the Hearings. SPI submits that, since indications were that order placement and installa tion lead-time are currently running in excess of 20 months, this factor must be addressed in more detail in the final Statement. 12. Again on Page 62, the Draft states that pre liminary assessments of the cost of compliance indicate that the expenditures to achieve such compliance will not be prohibitive. Without addressing the economics involved in detail here, reference should again be made to the statements in the record concerning ability to comply 4/ Transcript at 350 et seg., June 26, 1974 and at 455 et seq., June 26, 1974. BOR 004833 6 with the proposed standard; the testimony simply does not support the conclusion that economic consequences may not be prohibitive. Moreover, review of the Draft does not indicate that the preliminary assessment of cost of com pliance is supported by the data in Appendix C. This Appendix indicates, at Page 6, that control technology is available, and in some cases installed, for limiting vinyl chloride exposure. However, we have found nothing in Ap pendix C to indicate that technology which would eliminate exposure to vinyl chloride is either available or installed. 13. We hasten to emphasize this point because, on Page 63 of the Draft, it is stated that since the technology appears to be readily available and existing practices already result in low exposure levels, some hazardous function operations, housecleaning and maintenance improve ments required notwithstanding, the conclusion is that substantial development costs for vinyl chloride control technology will not be incurred. Continuing on the same page, there is a statement that no evidence exists to date indicating that the promulgation of the proposed standard will stop vinyl chloride production and use. Again, Ap pendix C does not support this conclusion and the evidence now in the hearing record as a minimum tends to controvert it almost completely. As a conclusion, its only support seems to stem from the statement on Page 64 indicating that PVC-reliant customers can be expected to sustain the industry despite the increased costs of polyvinyl chloride end products. 14. However, as pointed out above, industry members repeatedly pointed out during the course of the Hearings that the technology required to achieve a "no detectable" level of occupational exposure to vinyl chloride simply does not exist. Consequently, it is respectfully submitted that the final Statement should address the question of available technology in depth and in a more realistic light. Since compliance with the proposed standard would be abso lutely predicated upon the existence of technical know-how, SPI submits that it is essential that the final Statement address and resolve these questions and the probable effects of such a standard on an industry unable to achieve compliance, 15. Turning now to the treatment of "Alternatives" at Pages 73 through 75, the options OSHA sees available BOR 004834 -7 could be simply restated as (1) a ban on vinyl chloride production, (2) adoption of the current proposal, (3) re tention of the Emergency Temporary Standard, (4) complete reliance on personal protective equipment and (5) an oc cupational exposure limitation somewhere between 1 and 50 parts per million (ppm). 16. The first alternative, a ban on polyvinyl chloride production, is not, it is submitted, a viable alternative because (1) such action would be contrary to the public interest as a matter of common sense, and (2) the Occupational Safety and Health Act does not contemplate elimination of any industry. It is, therefore, urgently submitted that, since legal authority for such an action is lacking, further consideration of a ban as an alterna tive is inappropriate. 17. Insofar as the second alternative deals with the instant proposal, the comments in the preceding para graphs hereof on Probable Impact are wholly applicable and indicate the inaptness of this approach. 18. Alternative number 3, retention of the cur rent 50 ppm exposure level specified by the Emergency Temporary Standard, is stated, on Page 73, to have been rejected as inadequate because animal tests "indicate that exposure to vinyl chloride at 50 ppm may well constitute a serious health hazard to employees." This statement im plies that the conclusion is justified not only by animal toxicity studies but that such animal experience can be directly extrapolated to human experience. 19. It is respectfully suggested that this con clusion is no longer supported by the available evidence. During the referenced Hearings, considerable new evidence, interpretations and further reports on animal studies being conducted and their relationship to human experience were introduced into the record. It is the SPI position that in addition to the ongoing animal studies being con ducted, some of which were referenced in the Draft Environ mental Impact Statement, careful attention in the final Statement must be directed to the human experience data presented 5/ and the new toxicological research studies reported. fT/. IT See, e.g. , Transcript at 500, et seq., June 26, 1974 y See, c. g. , Transcript at 955, et June 28, 1974 a 01 BOR 004835 -8- 20. At Page 74, the last alternative offered in the draft Statement refers to the "judgemental" [sic] selection of an exposure level between 1 and 50 ppm. Such an alternative is stated to be viable only assuming that disease in man from vinyl chloride exposure is dose related and low levels are not hazardous to man. 21. Since this is precisely the essence of the medical and scientific evidence given in the Hearings, it is respectfully submitted that such evidence, entered into the record subsequent to the time when the Draft Environmental Impact Statement was prepared, should be thoroughly reviewed and given great weight prior to prepara tion of the final Statement. It is our view that the medical and scientific data specifically indicate a dose related response and that industry will do everything feasible to reduce the dose/exposure levels of vinyl chloride. This "Alternative," therefore, appears a feasible one, as does alternative three. 22. Finally, Appendix C, the Industrial Hygiene Survey Report on Vinyl Chloride and Polyvinyl Chloride Manufacturing Facilities, states, at Page 6, that vinyl chloride control technology is available and installed in some cases but that a reasonable time should be allowed for implementation of further engineering control methods such as local exhaust ventilation systems. It is important to note that this report does not and should not state or be interpreted to imply that the VCM exposure control technology currently available and implemented by the industry is capable of eliminating vinyl chloride exposure or making it possible for producers and manufacturers to reach a "no detectable" exposure level in the foreseeable future. * ** THESE PREMISES CONSIDERED, it is respectfully submitted that the Draft Environmental Impact Statement should be revised extensively so that the final Statement more completely and accurately addresses all of the issues as they have now been more fully developed. It is the BOR 004836 -9Society's view that unless the draft is so changed, the final Environmental Impact Statement may well lack the balance and objectivity required by the National Environ mental Policy Act. Respectfully submitted, THE SOCIETY OF THE PLASTICS INDUSTRY, INC. The Society of the Plastics Industry, Inc. BOR 004837 SHELL CHEMICAL COMPANY A DIVISION or SHELL OIL COMPANY ONE SHELL PLAZA P.O. BOX 2463 HOUSTON, TEXAS 77001 July 17, 1971* U. S. Department of Labor Occupational Safety and Health Administration Office of Standards Development Roam 500 1726 M. Street, N.W. Washington, DC 20210 Attention David R. Bell Gentlemen; Draft Environmental Impact-Statement June 12. 197** Proposed Regulation - Vinyl Chloride 29 CPR Part 1910 This submission by Shell Chemical Company, a division of Shell Oil Company, P. 0. Box 2t63, Houston, Texas, 77001 responds to the notice in 39 FR 1^522, April 2ht 197^, of OSHA's intent to prepare an environmental impact statement and the subsequent issuance of a draft of such statem nt on June 12, 1971*, The Draft Environmental Impact Statement was introduced formally into the public record by Edward Klein, solicitor for 0SHA, as evidence during the public hearings June 25, 197b in the matter of the Vinyl Chloride Proposed Standard 29 CFR Part 1910 (see transcript page 7 lines 17-18), Shell Chemical Company, commenting from the standpoint of a monomer producer only, disagrees with statements made in the Draft Environmental Impact Statement and questions its acceptability as a valid impact statement, as drafted for purposes of deliberating the necessity, feasibility or potential impact- of the Vinyl Chloride Proposed Standard. As drafted; l) It presents insufficient bases in fact or supposition to permit a reasonable estimate or judgement to be made of the technical feasibility or economic practicality of achieving the Vinyl Chloride Proposed Standurd. BOR 004838 U. S. Department of Labor 2 2) It 1b misleading with respect to: a) The Justification for a "no detectable level" standard. b) The feasibility and costs to achieve such a standard. c) The possible consequences to the work force and to the economy if the proposed standard was imposed. 3) It failB to cite some pertinent toxicologic and epidemiologic evidence and is imprecise and misleading in citations of some of the evidence which is presented. 4) Statements of the vinyl chloride monomer capacity operated by our company (Table I) and of the personnel exposure per unit of capacity (pg. 28) are incorrect. These overstate the available domestic vinyl chloride monomer capacity (by 660 million pounds per year) and understate the work force directly employed. 5) There is an error in one of the exposure levels in Table II. No acknowledgment is made of the substantial information on sampling conditions and methods given OSHA during and subsequent to the visit to the Shell Chemical plant referred to in Appendix C. 6) The references to cost of compliance and the availability of technology and implications as to feasibility on pages 62, 63, and elsewhere in the report are not Justified. It is apparent that these are attributable, at least in part, to a visit to our monomer plant at Norco, Louisiana the afternoon of March 13, 197^. At that visit, an OSHA industrial hygienist, an industrial hygienist trainee, and one OSHA fire protection specialist spent approximately 60 minutes touring the facility and another 90 minutes in discussions with our plant staff during the referenced "fact-finding survey." It would be extremely difficult even for engineering and design per sonnel highly qualified in the specifics of vinyl chloride manufacture to perform a preliminary investigation to relate exposure levels to equipment source, equipment capability, and to the operating conditions during such a brief visit. These considerations do not permit acceptance of OSHA's contention that compliance with the proposed standard is technically feasible and carries little economic consequence based as it is on the short visit and discussion by the OSHA representatives cited above. BOR 004839 U. S. D pertinent of Labor 3 7) With respect to our operations, the report gives an incorrect impression that our housekeeping was poor and our maintenance inadequate or non-existant. Such misrepresentation invites an erroneous impression that more effort merely on housekeeping and maintenance will permit easy compliance with the vinyl chloride proposed standard. The last sentence on page 6 of Appendix C "Usually, a time period of six months may be sufficient to install VCM emission controls..." is not Justified. 8) The report possibly could generate unwarranted uneasiness amongst the public and our workers as to our Company's attitude, progress and efforts to deal with the VCM problem. Contrary to the implications in Appendix C of the impact statement, our equipment is evacuated and purged before attempting maintenance, vessel entry is seldom necessary and requires a signed permit. We have an established medical surveillance program (see reference 3, bibliography pg. 51)i our housekeeping and maintenance programs are thorough. We shut down operations when equipment malfunctions cannot be readily corrected during evening hours or in any case when continued operations would significantly increase worker exposure levels. Substantial maintenance is better investigated and planned in daylight hours when visibility is better. 9) The rigorous definition and imposition of a "no detectable limit" standard as proposed would require our discontinuance of vinyl chloride monomer manufacture. This would deprive industry of about 23% of the installed monomer capacity in the U.S.A. and cause a very serious upset to the PVC industry and to other major industries dependent on PVC. Loss to the U.S. economy could be serious as suggested by testimony at the recent public hearings and which OSIIA could confirm by thorough economic impact studies. The Draft Environmental Impact Statement suggests there may be alternatives to PVC but does not identify viable substitutes. Shortages of some natural or synthetic products which might be suggested may already be severe and it would be expected that considerable retooling may be required to accomodate such substitutes as may be viable. Attachment I to this letter is a copy of portions of the Draft marked to identify those portions which should be modified. We believe the need for revision in many of these cases will be readily apparent to OSHA in the light of our comments and of testimony at the recent public hearings dealing with evidence previously and newly available. Accordingly, we shall not comment on all of these cases. Attachment II offers comments on those numbei-ed portions identified in Attachment I, which are most objectionable to us from the stand point of need and feasibility as seen from the vantage point of a monomer producer. BOR 004840 U. S. Department of Labor 1* We request that OSHA include this letter and its attachments as part of the record in opposition both to the Draft Environmental Impact Statement and to the Vinyl Chloride Proposed Standard 29 CFR Part 1910. We request that OSHA give serious consideration to the comments in this letter and its attachments as well as to the comments previously submitted by our letter of June 25 197^ re 29 CFR Part 1910 before promulgating a permanent standard. Very truly yours. R. J. Reynolds, Manager Chemical Intermediates BOR 004841 Cl SOUTH CHARLESTON PLANT UNION CAriDE CORPORATION CHEMICALS AND PLASTICS P.O. BOX 8004, SOUTH CHARLESTON, W. VA. 25303 July 17, 1974 1 Mr. David R. Bell Office of Standards Development Room 500 Occupational Safety and Health Administration Department of Labor 1726 M Street N. W. Washington, D. C. 20210 Draft Environmental Impact Statement-Vinyl Chloride Dear Mr. Bell; Attached are detailed comments on the Draft Environ mental Impact Statement-Vinyl Chloride to be attached to a general state ment sent you earlier by Mr. J. W. Whittlesey Union Carbide Corporation 270 Park Avenue New York, N. Y. I hope these additional comments will be of value in revising the Draft Statement. Very truly yours, ./!' Attachment. cc: Mr. J. W. Whittle sly Dr. A. B. Steele Dr. N. L. Zutty Mr. M. E. Eisenhour Mr. J. L. Carvajal R. N. Wheeler, Jr, . BOR 004842 DRAFT ENVIRONMENTAL IMPACT STATEMENT Proposed Regulation Vinyl Chloride COMMENTS Summary Pago 2 The second paragraph implies that 13 people in the U. S. died recently of angiosarcoma. The initial death in this series occurred in 1961 and the last two occurred in 1974, a 14 year period. Summary Page 3 The method of analysis as specified permits a variability in absolute yinyl chloride concentration of 0. 3 ppm to 3 ppm. The propos d standard .calls for no detectable by this method but the last paragraph states that the proposed standard is to assure that levels do not go above 1 ppm. In addition it*states that*the employer is required to initiate engineering and work practices dejsigned'to bring the level below 1 ppm. This is all very confusing. . Summary Page 4 The last paragraph states that the proposed standard will reduce pollution of the environment external to the immediate work place. This is a conclusion based on no data. All discussions in regard to control of the work place air have stressed ventilation i.e. remove th .vinyl chloride from the work place and blow it into the external air. Summary Page 5 "The proposal is not without adverse consequences. s The standard for the most part will likely cause a slight decrease in productivity and a small increase in costs for products made from vinyl chloride." 4 BOR 004843 Summary Page 5 fCont'd) This is a conclusion not based on the facts presented in the statement and is contrary to industry statements that the proposed stand ards will cause withdrawal from the business. The carcinogenic potential of vinyl chloride will not initiate a search for substitutes for polyvinyl chloride products are not hazardous to man; therefore, the only incentive to replace them will be economic. This does not fit with the statment that productivity will decrease slightly and there will be a small increase in costs of PVC resins. Page 22 IV Occupational Exposure to Vinyl Chloride Paragraph 2 This paragraph ignores the fact that after the vinyl chloride poly merization step the polymer is exposed to a vinyl chloride stripping or removal step. The final vinyl chloride monomer content of the resin is a function of resin particle size, particle porosity, and the efficiency of the monomer removal operation. The unconverted monomer contained in the resin is a factor in worker exposure only if ventilation at the first processing is poor or if the worker enters a closed vessel containing resin. OSHA is obviously concerned with the migration of VC to the surface of a PVC product since the proposed standard often refers to resin containing detectabl quanti ties of vinyl chloride monomer. Page 25 (1) Process Descriptions "Until the late 1950's VC was generally produced from acetylene and hydrogen chloride. " Vinyl chloride was initially produced in the U. S. by caustic hydrolysis of ethylene dichloride. This process was followed by pyrolysis of ethylene dichloride to vinyl chloride and hydrogen chloride. Since hydro gen chloride was a pollution problem, the material was reacted with acetylen to yield vinyl chloride. The statement that vinyl chloride prior to the 1950's was generally produced from acetylene and hydrogen chloride is erroneous. "Acetylene Route ., , The product gases are then purified to vinyl chloride by water and alkaline scrubbing, drying and.finally fractional distillation. " ^ The product gases are fractionally condensed. The liquid conden sate is then fractionally distilled to recover the pure vinyl chloride. The purified vinyl chloride is often caustic scrubbed after distillation. BOR 004844 Acetylene Route (Cont'd) The oxychlorination process from ethylene to ethylene dichloride to vinyl chloride is replacing the "balanced" or acetylene route because of the high cost of acetylene, not because of greater efficiency. 3 Pose. 28 Process Descriptions The differences noted between PPG and Shell in workers employed per million tons of vinyl chloride capacity is due to failure to secure the same information from both producers. Shell is giving information on all workers involved including maintenance and services whereas PPG has given informa tion on only workers directly involved in production. 33 Process Descriptions "Four basic processes ** polymerization* The bulk process is a dry process requiring no water, suspending agents, or emulsifiers, the other three processes require water, solvents, or other liquids, but they are similar enough that they can be used in the same equipment. " This statement implies that any given suspension, dispersion or solution polymerization plant can operate on any other process. This impli cation is erroneous. Each process usee a specialized plant to produce products for a particular market. Page .33 (1) Process Descriptions In the United States approximately 78% of PVC resins are produced by suspension polymerization, 13% by emulsion polymerization (not solution as printed), 6% by bulk polymerzation and 3% by solution polymerization. Pago 34 Suspension Polymerization The PVC slurry is then blended in another vessel with other batches to reduce small variations, and dewatered by a continuous solid bowl centrifugal (Supcrdecanter is a trade name) to yield a polymer cake containing about 20% moisture. 'N qq4B^ BOR Page 34 Emulsion Folvm rization "This process is very similar to the suspension process and is used to produce very fine particles. There are two primary differences: (1) Usually two emulsifying agents are soluble in water and one soluble in the monomer, are used to prevent coalescence of the polymer particles, and (2) The polymer is separated from the water by spray drying." This is erroneous. The suspension polymerization process uses mechnaical mixing to suspend monomer particles in water and thereby pro duces large spherical particles. The emulsion process uses one or more surfactants and agitation to convert the monomer and water mixture to a stable emulsion containing very fine .particles of monomer which polymerize to very fine particles of resin in a stable latex. The polymer is recovered by spray drying because there is no choice but to use this form of drying. Page 35 Bulk Polymerication "The output of bulk processing plants is said to be more than twice that of good suspension plants of comparable size. " A resin plant is normally sized by its output.; thus this statement is in error. The author may have meant that output per fixed investment dollar is twice that of suspension plants. Page 36 Solution Polymerization The author of this section obviously took this information from an ancient patent. The process description is erroneous. Page 53 V The Proposed Standard Detailed comments on this Proposed Standard are as follows: N BOr 4846 harvey hubball incorporated HARVEY HUBBELL INCORPORATED 984 Darby Milford Road Orango, Connecticut 06477 (203) 789-1100 // July 22, 1974 Mr. David R. Bell Office of Standards Development Room 500 1726 M Street, N. W. Washington, D. C. 20210 Dear Mr. Bell: I understand that the deadline for comments on the draft environ mental impact statement for vinyl chloride has been extended, there fore, we request that our comments contained in this letter be considered before a final environmental impact statement is issued. Harvey Hubbell, Incorporated is a Connecticut Corporation with operations producing electrical wiring devices, outdoor lighting products, electrical control equipment, specialty electric cable, communications equipment and commerical plastic molded products. Our concern with the vinyl chloride impact statement arises primarily from our use of FVC in our plastic molding operation and in our specialty electric cable operation. We are unable to offer technical substantiation for our comments beyond the attached report prepared by the Liberty Mutual Insurance Company at our Kerite Company Subsidiary, the producer of specialty electric cable. We believe, however, that the attached report substantially confirms much of the comment at the public hearings on the proposed OSHA stand ard in regard to the almost non-existent hazard associated with the handling and storage of FVC in the diced or pelletized form. The draft environmental Impact statement of June 12, 1974 could be modified on page 22, by rewriting the last sentence as follows: "Since the proposed OSIIA regulation is concerned only with the worker potentially exposed, the migration of VC to the surface of the diced or pelletized PVC compound or of u FVC product has not been considered." BOR 004847 Mr. David R. Bell--2--July 22, 1974 Wc be Move that this addition will make clear that the VC monomer is probably not present in detectible levels in the materials used for conversion to the final product. We can see the possibility that residua], monomer may be released during the conversion process. We arc concerned in this case with regulations governing the unloading, storage and handling of the diced or pelletized compound. Page 23, first sentence of the second paragraph does not, we believe, express what was intended by the writer of the statement. We believe that there has been some confusion about the fourth stage product and that the term "extrusion stock" is intended to include milled pel-lets or diced material. We believe this inclusion should be stated specifically, and that the fourth box from the top on figure 1, page 24, should also be reworded to specifically include the diced or pelletized form of FVC. Wp are concerned with the last paragraph on page 49 headed " (2) Worker Exposure." The second sentence of this paragraph uses the term raw materials to describe the material used in the fabricating stage. We believe that the general interpretation of the term raw materials would apply to a product prior to compounding and converting it into the diced or pelletized in-process material, and we recommend study of this sentence for the purpose of clarification of the meaning intended. Page 53, last paragraph, states that "fabricated products include such items as..................... " In this case we again reconvnend that the description be modified to include specific reference to the pelletized or diced in-process material. Pages 63 and 64 seem to understate the problem of potential interrup tion of production of vinyl chloride and FVC. We believe that an argument can be supported with substantial logic to the effect that conversion to the proposed OSHA standard can cause substantial interruption in the supply of both the monomer and FVC, that prices of the products may increase substantially, and that the competitive position of the manufacturers of the end products could be seriously affected ]jy such reduction in supply and increase in price levels. We must repeat, other than on the attached copy of an inspection report at our subsidiary's plant, we are unable to supply substantiat ing technical data, but we suggest that an examination of the record of the testimony at the OSHA hearings on the proposed regulation related to the environmental impact statement will produce testimony and, hopefully, test data which will support pur position. Sincerely , WllCrarl William Vice President BOR 004848 AMERICHEM, fNC.. 2038 MAIN STREET. CUYAHOGA FALLS, OHIO 44221 (216) 929-4213 July 24, 1974 Mr David R Bell Office of Standards Development Room 500 1726 M Street N.W. Washington, D.C. 20210 Dear Mr Bell: Enclosed is a copy of our comments relative to the proposed OSHA standard for vinyl chloride monomer exposure. We have chosen this method of comment rather than personal presentation. Thank you for including it in the minutes of the proceedings. Very truly yours AMERICHEM, INC; JLS/md attachment Ocr `John L SSaatterfield New Products Manager BOR 004849 COMMENTS ON THE DRAFT ENVIRONMENTAL IMPACT STATEMENT PROPOSED STANDARD FOR OCCUPATIONAL EXPOSURE TO VINYL CHLORIDE Americhem is a pvc processor engaged in the manufacture of color concentrate compounds which are used by other PVC processors. Our unique position as both user and supplier puts us into close contact with all aspects of the vinyl industry and because of the multiplier effect of the low usage levels of our product, we have access to a sizable portion of the market. In addition, our management has been associated with the development, manufacture, compounding and processing of PVC resin since shortly after World War II. It is this background of long association with this industry that makes us feel compelled to offer our comments as to the probable effects that this proposed standard will have on us and on our customer. We have no expert opinion to offer as to the existence or nonexistance of carcinogenic hazard from vinyl chloride monomer and we do agree that if a hazard does exist then reasonable steps should be taken to either eliminate it or control it. Our concern is with the very real economic impact that will be felt if over reaction causes productive capacity to be shut down rather than comply with over restrictive controls. PVC resin is presently in short supply. Presently this is due to the combination of petroleum shortage, increased demand and inadequate production capacity. During the recent Arab oil embargo PVC processors had great difficulty in purchasing adequate supplies of resin and, as a matter of fact, some companies were unable to buy any at all. It i has been our experience that shortages have not been equally distributed over the industry but rather were quite spotty in their effect with some BOR 004850 tag 2 July 24, 1974 users being hit quite hard while other more fortunate ones were hardly affected. A number of reasons can be advanced for this result. Some processors through their purchasing policies had either limited their own sources of resin or had so negotiated the price that their suppliers felt encouraged to phase out their business when allocation time came. Some grades of resin had become so competitive or improfitable that suppliers chose to discontinue them in favor of more profitable grades. Some customers were favored over others either because of geographic proximity or because of other relationships that had been develop d over the years. Each situation was different but the point is, supply shortages affected different people differently and unequally. The whole thrust of this discussion was to support the proposition that what may seem to an outside observer to be a minor disruption in supply may well have a devastating effect on some people and almost none on others. OSHA's own impact statement recognized that increased cost of compliance with the standard would threaten marginal producers. By OSHA's own figures there are seven plants out of thirty-six which produce less than 100 million pounds of PVC per year. If just one of these plants were forced to close, it is a good bet that some of their customers would not be able to replace this loss and would have to curtail their production. BOR 004851 3uly 24 Page 3 It is also a reasonable assumption that any productivity decrease in the larger plants would not be distributed evenly. For one reason or another this decrease would be unevenly felt by their customers and in all probably would result in severe hardship to some processors ven to the point of closing them up. We have had a number of experiences in which we have invest d substantial time, money and effort into development programs which have fallen through when resin suppliers dried up. Jobs have be n eliminated and product lines canceled not because they were non-productive or non-profitable, but because resin was not available. Increased production costs may not be distributed equally eith r. Resin prices vary with grade and with volume. If product lines are drop because of marginal profitability, some customers will be forced to use alternate grades of resin which may be considerable more costly than the proprotional increased production cost. No doubt, competitiv forces will connect this problem when production catches up with demand but until then some processors will bear a disproportionate share of the burden. Another probable result of decreased domestic production will be an increase in the purchase of imported PVC resin. Aside from inter national balance of payment problems, importing PVC is less than desirable. Not only will any increased cost be disproportionately distributed to the industry but there is some real chance that residual monomer will BOR 004852 Pag 4 July 24, 1974 be higher in foreign material than in domestic. If so then use of such resin will increase our hazard to domestic workers rath r than lessen it. Responsible industry experts have proposed a step wise reduction in exposure which will have minimum impact on production. We urge serious consideration be given to the adoption of this proposal. It i our view that the certainty of serious economic effects outweigh the possible benefits of an over restrictive regulation. We ask that the regulation finally adopted be established in such a way as to minimize unequal burdens on our segment of the vinyl industry. Respectfully submitted, July 24, 1974 John L Satterfield \ BOR 004853 August 1, 1974 UNITED STATES DEPARTMENT OF C MMERCE The Assistant Secretary for Science and Technology Washington, O.C. 20230 }L> Mr. David R. Bell Office of Standards Development 1726 M Street, N. W., Room 500 Washington, D. C. 20210 Dear Mr. Bell: The draft environmental impact statement for the proposed "Regulation Vinyl Chloride," which accompanied your letter of June 17, 1974, has been received by the Department of Commerce for review and comment. The statement has been reviewed and the following comments are offered for your consideration. General Comment The draft statement furnishes a rather comprehensive and generally accurate description of the processes used in the vinyl chloride industry. The following weaknesses are evident. (1) Critical judgment has not been applied to some of the data reported, and invalid and unsupported generalizations are numerous. (2) The scope of the impact of the proposed regulation is limited and conspicuous by the lack of documentation. (3) A time plan offering an orderly transition has not been presented. We suggest that the statement be revised to accommodate these points. S .tMCAjv BOR 004854 -2- Specific Comments X. Summary Introduction, page 1-3 The manner of presenting pertinent information on vinyl chloride implies precipitous action without adequate justifica tion. To soften this effect the second paragraph on page 1 may be inserted at the end of the Introduction. The discussion of health problem on page 2 relates only 4 deaths from li^er angiosarcoma among workers with industrial exposure to vinyl chloride in this country. A total of 19 deaths are declared from angiosarcoma, 13 of which occurred in this country. The remaining six cases of angiosarcoma which are recorded presumably occurred outside the U. S., but the etiology of these cases is not clearly related to vinyl chloride. The last paragraph of the introduction which ends on page 3 explains why the Occupational Safety and Health Administra tion (OSHA) established a temporary standard for vinyl chloride at 50 ppm and implies that a permanent standard of no detectable level (1 ppm +0.5 ppm) will adequately assure no material impair ment of health or functional capacity of men exposed for the dura tion of their working lives. The available evidence indicates the need for a permanent standard, but use of available data to support the claims for the proposed permanent standard is not apparent. --- ' s The proposed range of alternates u*. expanded to include the possibility that results of additional testing may indicate a safe level. The second sentence asserts that hazards of vinyl chloride have been assessed. An interim evaluation has been made> but scientific data which support the parameters used in the assessment have not been presented. It is agreed that retaining 50 ppm as a standard level may be un tenable. However, since a dose response has been reported, the degree of hazard will depend on the amount and durationsof the exposure. The reason:, for not using this in forma tion in selecting the proposed standard should be explained. BOR 004855 II. Background Page 7, paragraph 1, reports that on January 22, 1974, B. F. Goodrich identified four deaths among their employees of angiosarcoma of the liver. It is our understanding that only three such deaths were identified at that time. The fourth was, as of that date, only identified as liver cancer of unspecified type. Ill, Hazards of Vinyl Chloride and Polyvinyl Chloride This section appears to be a historical account of the toxicology studies with vinyl chloride. In several instances alleged effects have not been precisely identified with the cited documents. Pertinent information has been cited which apparently was not used in the subsequent evaluation of hazards of exposure. Information used to support the establishment of safe vinyl chloride levels in air has not been clearly identified. In the first paragraph of page 15 reversible changes in liver functions were mentioned. Available results of these tests apparently were not considered in selecting the 50 ppm interim standard or the standard of "no detectable amount." An explana tion of this omission is necessary to justify requiring liver function studies of humans in the proposed monitoring studies. On page 17 the impression is given that all the pathology reported is considered to constitute a syndrome of interrelated symptoms. The wide disparities in the comparative incidence and/or the association of these symptoms in affected employees in different studies reported in the literature do not appear to support that concept. In the second paragraph, page 18, occurrence of angiosarcoma* in employees of the B. F. Goodrich company is cited. However, no mention was made of the incidence of angiosarcomas reported among vinyl chloride workers by Union Carbide, Firestone Tire and Rubber or.Goodyear cited Ln F. R. 39:92 May 10, 1974. The reason for this omission should be explained. No data were presented which permitted relating occurrence of tumors with the rate of exposure, or the type of work performed. This omission seriously limits the range of amounts to be considered in selecting a safe level of exposure. 004856 bob -4- On page 19, the reference to Industrial BIO-TEST Laboratories studies fails to identify the experimental animals in which the experimental findings were observed as mice rather than rats which were used in earlier studies. IV. Occupational Exposure to Vinyl Chloride In the second sentence of the first paragraph on page 22 reference is made to the "mechanism of carcinogenesis ... Relevance of the mechanism to an assessment of hazard has not been identified. How knowledge of the mechanism might influence the selection of a standard value is not clear. The last sentence of the second paragraph on page 22 infers that the regulation is concerned only with potential hazard. In reality the hazard of exposure is the factor to be regulated, and the extent to which hazards may be regulated should be influenced by the gravity of the consequence. In this case the potential hazard is the tendency for vinyl chloride to be released. The hazard is the amount of vinyl chloride in the air breathed by workers. Worker Exposure, page 27 The discussion of the numbers of employees involved in production of vinyl chloride is a typical example of the authors' failure to evaluate critically the data they report. The cited levels of employment cannot possibly be per million tons of stated capacity (which would give PPG somewhere between 0,3 and 0,6 employees to operate the Lake Charles plant), nor can it be per million pounds capacity (in which case the entire 1500 people reported for industry would be required to operate the plant). In the last paragraph on page 28 reference is made to timeweighted-average of exposure of workers in different categories. However, no attempt is made to make these projections with available data or to confirm the validity of the projection by comparing occur rence of adverse effects of exposure with the exposures sustained by workers in the different categories. BOR 004857 - 5- In the last two sentences at the top of page 30 the state ments are made "time-weighted-averages are generally well below 50 ppm" and without information on sampling time and analytical method ''the data cannot be used to estimate the employees exposure to vinyl chloride." Reconciling the validity of both of these statements is difficult. Worker Exposure, page 36 It is apparent that all available data have not been con sidered in assessing worker exposure to vinyl chloride. Although adequate air sampling information may be lacking, other references cited in the Acroosteolysis section on page 15 indicate results of several recent epidemiological studies which may be useful in comparing rates of occurrence of adverse effects of exposure with job categories of workers. No attempt has been made to relate the occurrence of angiosarcomas or other adverse effects among workers in different plants with job -categories of workers. It is of interest to note that the Goodrich Chemical Company cited several cases of angiosarcoma among its workers but Dow Chemical Company did not. Some justification probably should be offered for failing to discuss this difference. On line 14 of page 36 a range "between 4,000 and 20,000," is stated. It is not clear what these values represent; do they refer to the number of processing firms, or the number of employees? V. The Proposed Standard, page 53 The term "detectable amounts" is misleading and difficult to enforce. To avoid confusion a finite value should be specified, i.e., 1 ppm as measured by a method with sensitivity of 1 ppm + 50 percent. Industrial sources claims that adherence to no detectable levels would cause close down of the industry due to the lack of technology to completely eliminate exposure. As a short-term interim standard consideration could be given to the proposal set by the Society of Plastic Industry (SPI) of concen tration of 40 ppm through October 1974, with scheduled reductions as set forth by SPI. (Chemical and i;ng. News July 22, 1974, pages 9-10). While the SPI recommended schedule may prove to be some what on the high side, the risks from such exposure levels over a BOR 004858 6 limited time period would appear to be nominal. There should be a re-examination of all relevant data within 12 months to determine whether firm factual information has been developed to establish a standard substantially lower than the SPI proposal, VI. Probably Impact of the Proposed Standard, page 60-65 In the space of 4 pages the editors have attempted to present the substantive matter relating to the title of this document. The first paragraph on page 60 states: "the major impact of the proposed OSHA standard ... is a working place free of vinyl chloride exposure." This assumes the attainability and the enforceability of the proposed standard and ignores the basic considerations that the proposed standard is an effective 1 ppm ceiling standard, and that its attainment would not constitute a workplace free of vinyl chloride exposure. In the second paragraph the capital and operating costs of complying with the standard are discussed. The feasibility of compliance is implicitly assumed and no consideration is given to the possibility that efforts at compliance may engender unlimited capital and operating costs and still fail of achieving their goal. The statement is made that, as vinyl chloride is a product dependent upon nonrenewable natural resources, a reduced demand for vinyl chloride could be considered an environmental benefit. Without an expressed comparison of the stresses on the environment from the production of vinyl chloride as compared with those involved in production of substitute materials, such a statement is sheer speculation. Termination of production of VCM and PVC resin, and replace ment of PVC products with other material, is not a viable option. In many cases, there is no reasonable substitute material which can serve as a replacement material. In many cases, the required quantity of replacement material would not be available on short notice. Hence, the economic impact on downstream industries would be very significant if PVC resins were not available. The concluding section of this statement "that a preliminary assessment of the cost of compliance indicates that expenditures required will not be prohibitive" is completely unsupported by BOR 004859 7 evidence in this document. The industrial hygiene on-site survey referenced in this identified techniques for reduction of vinyl chloride exposures but nowhere makes the judgment that these tech niques would be adequate to achieve compliance with the "no detect able level" standard. The reduction in productivity associated with efforts to comply with this "no detectable level" standard has been estimated as high as 50% by union representatives. At the current OSHA hearings industry representatives have testified that,for all intents and purposes, productivity would decline to almost zero. The Industrial Union Department of the AFL-CIO is reported to have estimated that 700,000 men and women are exposed to vinyl chloride monomer in monomer, polymer, secondary, and tertiary production. The authors also state: "because of turnover of employees, the population over time exposed to vinyl chloride will be significantly larger than any estimate of the working population exposed." The number cited by the union refers to people working in the identified industries and has no relationship to the number of employees exposed to vinyl chloride monomer. A great majority of these people work in secondary and tertiary operations with no known evidence of vinyl chloride monomer exposure. Exception must be taken to the presentation of this kind of unsupported generali zation. VII. The Relationship to Other Federal Actions, pages 66-72 Regulatory Activity, page 66 The reference to the EPA tests on vinyl chloride aerosols erroneously associates the 400 ppm vinyl chloride monomer in the air of a closed room with a reported persistence of vinyl chloride in a sealed space. The implication that only about 1% of vinyl chloride propellant would dissipate in 4 days from a room in which an aerosol product is used seems totally unwarranted. Vinyl chloride has been banned by FDA as a propellant in hair sprays and other cosmetics, and by EPA in insecticides. Air pollution threat by VCM around plants may require closii down ventilation systems outlets. However, EPA has stated that VCM is not a threat now around plants as more than 95 percent of r BOR 004860 i -8- samples taken showed levels of less than 1 ppm. Pollution of plant water effluents varied in the amounts of VCM depending with degree of waste water treatment. Highest level found was 20 ppm, but typical levels were 2-3 ppm. EPA has also stated that there is no evidence to indicate VCM is presented in detect able levels in drinking water. In the first paragraph, on page 71 the discussion of EPA ongoing research programs, reference is erroneously made to "the mutagenesis and tcratogenesis of angiosarcoma." Presumably the intent was to identify studies of possible mutagenesis and teratogenesis by vinyl chloride monomer. In the same paragraph "paralytic degradation of plastics" should read pyrolytic. In the discussion of alleged liver problems in hatcheryraised fish, if in fact the ultimate cause is the plasticisers in flexible tubing, such tubing should be identified as such. PVC pipe, such as is used in domestic water supply systems, is prepared from unplasticized resins. VIII. Alternatives, pages 73-75 It must be kept in mind that the proposed standard, to which the listed alternatives are compared, does not "eliminate vinyl chloride from the workplace air." The standard of "no detectable exposure," as written, constitutes a 1 ppm ceiling standard, not a "zero exposure." The points made in the fourth alternative against depen dence upon respiratory protection for workers are well taken, and OSHA should recognize that the promulgation of a workplace standard that cannot be met by engineering and work practices changes will inevitably result in the situation there portrayed. The fifth alternative, the setting of a vinyl chloride standard at some point between 1 ppm and 50 ppm, is rejected on the ground "in the absence of scientific evidence to conclusively establish a safe level selection of a permissible level between 1 and 50 ppm would be judgmental." This certainly is true, but it is no less arguable that the selection of a "no detectable level based on a 1 ppm level sensitivity" is also judgmental and just as unsupported by scientific evidence as would be some nund set at a higher level between 1 and 50 ppm. BOR 004861 M 9 ** The reported occurrence of angiosarcoma among employees with long histories of exposure to vinyl chloride offers con vincing evidence of the need to establish an allowable rate of exposure to humans. However, there appears to be no attempt to relate this effect to the degree of exposure or the type of work assignment of each stricken individual. Lack of this information hinders assessing a cause and effect relationship needed to justify the selection of the 1 ppm level published in the Federal Register May 14, 1974. The significance of the results of studies with experi mental animals was not discussed. Two investigators reported the same levels of no-effect (50 ppm) from long-term feeding studies with several animal species. A graded response to dosage was reported by Maltoni (page 18) which indicates possible drug effect type of response and a reasonable possibility to establish a safe level of exposure. Rowe reported that low levels of vinyl chloride may pose little hazard, but high levels may overload metabolic pathways and cause subsequent carcinogenic metabolities. Thank you for giving us an opportunity to provide these comments which we hope will be of assistance to you. We would appreciate receiving a copy of the final statement. Sincerely, Sidney R. G&ller Deputy Assistant Sefcretary for Environmental Affairs 004862 BOR n ffiLui (Ss dilynaatfELrosfjibl>erfeospaiuy ATfopanim 9 Hurceu 4t4LS3 H <S August 2, 197^ Hr David R Bell Office of Standards Development Occupational Safety and Health Administration U S Department of Labor Room 500 1726 M Street, N W Washington, D C 20210 Re: Draft Environmental Impact Statement on Proposed Action to Limit Exposure of Workers to Vinyl Chloride Dear Mr Bell: The Goodyear Tire & Rubber Company, in commenting on the Draft Environmental Impact Statement on Vinyl Chloride, is not interested in reciting the text of its submission or in restating a general industry position advanced during the informal hearings on the Proposed Standard for Occupational Exposure to Vinyl Chloride, held June 25, 197^ through July 11, 1971!* It is Goodyear's intent, however, to take strong excep tion to the Department of Labor's position that the proposed level of exposure to vinyl chloride is currently technically achievable and that the economic impact of the proposed st."'.; '-rd on '.'ll '! . The Draft Statement, at pages 5 and 62, draws conclusions from Appendix C, an on-site survey of several vinyl chloride (VCH) and polyvinyl chloride (PVC) manufacturing facilities. One of those facilities surveyed was Goodyear's PVC bulk polymerization plant in Plaquemine, Louisiana. This facility is an outdoor plant where little improvement in VCM exposure can be accomplished by forced ventilation. The 8-hour TWA mean for all operators in its open reactor building with the latest in modern equipment and controls is 8 PPM with a range of 1J+ to 28 PPM over a 27-day period. While this is a low exposure level, it is nevertheless an exposure level above "no detectable level." BOR 004863 Mr David R Bell Page 3 contained in the last alternative offered in the Draft State ment at page 75. As the great weight of evidence indicates that disease from vinyl chloride exposure is dose-related and at low levels not hazardous to man, this is the only feasible solution suggested in the Draft Statement. In conclusion, Goodyear respectfully submits that the SPI recommendation of a graduated standard with an eventual limitatloh of 25 PPM ceiling with a TWA limit of 10 PPM is a realistic and achievable goal. Sincerely, D H Francis eg REGISTERED AIRMAIL RETURN RECEIPT REQUESTED Director of Chemical Production BOR 004864 Labor Organizations Mr. Arnold Mayer Legislative Representative Amalgamated Meat Cutters and Butcher Workmen 2800 North Sheridan Road Chicago, Illinois 60657 Mr. Peter Bommarito President United Rubber, Cork, Linoleum and Plastic Workers of America 87 South High Street Akron, Ohio 44308 Mr. Angelo Cafalo Special Assistant to the International President International Association of Machinists and Aerospace Workers Machinists Building 1300 Connecticut Avenue, N.W. Washington, D.C. 20036 Mr. Adolph E. Schwartz Director Safety and Health Department United Steelworkers of America Five Gateway Center Pittsburgh, Pennsylvania 15222 Mr. Sheldon W. Samuels Director Industrial Union Department, AFL-CIO 815 Sixteenth Street Street, N.W. Washington, D.C. 20006 Mr. Anthony Mazzocchi Director Oil, Chemical and Atomic Workers International Union 1126 16th Street, N.W. Washington, D.C. 20036 Mr. Louis S. Bellczky Director of Industrial Hygiene United Rubber, Cork, Linoleum and Plastic Workers of America 87 South High Street Akron, Ohio 44308 s BOR 004865 Mr. Harvey R. Robinson Attorney at Law 609 Third Avenue Freedom, Pennsylvania 15042 Mr. William E. Nichols Consultant Organization Resources Counselors, Inc. 1660 L Street, N.W., Suite 212 Washington, D.C. 20036 Mr. Onslow B. Hager Environmental Advisor Alco Standard Corporation Valley Forge, Pennsylvania 19481 Mr. Michael J. George Director Canvas Products Associate International 600 Endlcott Building St. Paul, Minnesota 55101 Ms. Donna J. Roberts Attorney The Dow Chemical Company Bennett Building 2030 Dow Center Midland, Michigan 48640 Mr. Martin J. Klelnfleld Director Uniroyal Chemical, Inc. Elm Street Naugatuck, Connecticut 06770 Mr. William W. Sadd President and General Manager Glass Container Manufacturing Institute 1800 K Street, N.W. Washington, D.C. 20006 Mr. David A. Weinstein Attorney Borden, Inc. 277 Park Avenue New York, New York 10017 Mr. Paul I. Weiner Associate Counsel Certain-Teed Products Corporation Post Office Box 860 Valley Forge, Pennsylvania 19482 Miscellaneous Dr. Everett Marcum Chairman, Safety Studies Department West Virginia University Room 280 Coliseum Morgantown, West Virginia 26505 Mr. C. Nelson Codding Cooperate Environmental Control Jim Walter Research Corporation 10301 Ninth Street North St. Petersburg, Florida 33702 Mr. Charles E. Kupchella Administrative and Scientific Coordinator University of Louisville Health Sciences Center Louisville, Kentucky 40201 Mr. John Messervey Refinished Mouldings Manufacturers Association 1201 Waukegan Road Glenview, Illinois 60025 Mr. Edwin A. Olsen Secretary and Treasurer Compressed Gas Association, Inc. 500 Fifth Avenue New York, New York 10036 Mr. Ulrich H. F. Wollmann Representative of the Huls-Group for the United States of America 750 Third Avenue New York, New York 10017 Mr. H. Paul Friesema Associate Professor Northwestern University Center for Urban Affairs 2040 Sheridan Rd. Evanston, Illinois 60201 Dr. William Olson 2347 Paddock Lane Reston, Virginia 22091 BOR 004867 Mr. R. F. Kalmbach Jomact Inc. 863 Easton Road Warrington, Pennsylvania 18976 Mr. William H. Gatenby Vice President Harvey Hubbell Incorporated 584 Derby Milford Road Orange, Connecticut 06477 Mr. Barton J. Menitove Collier, Shannon, Hill and Edwards 1666 K Street, N.W. Washington, D.C. 20006 Mr. Thomas F. Mitchell Executive Representative Georgia-Pacific Corporation 1735 I Street, N.W. Washington, D.C. 20006 Mr. Robert F. Magill Vice President Industry Government Relations General Motors Corporation 1660 L Street, N.W. Washington, D.C. 20036 Mr. Jerome H. Heckman Keller and Heckman 1150 17th Street, N.W. Suite 1000 Washington, D.C. 20036 Mr. John C. Gmelch New England Plastics Corporation 310 Salem Street Woburn, Massachusetts 01801 Mr. Robert I. Martin President RIMAR, Inc. 27 East Ferdinand Street Manheim, Pennsylvania 17545 Mr. George E. Field Vice President and General Manager 1450 South Chillicothe Road Aurora, Ohio 44202 Mr. John D. Farr Technical Service and Development Manager Emergy Industries, Inc. 4900 Este Avenue Cincinnati, Ohio 45232 Mr. Harold Jones Scandura Company Post Office Box 949 Charlotte, North Carolina 28201 Mr. Earl F. Webster UNILOK Belting Division Georgia Duck and Cordage Mill Scottdale, Georgia 30079 Mr. Thomas F. Humphries Fenner America 400 East Main Street Middletown, Connecticut 06457 Mr. Lyall Morrill, Jr. Lyall Electric, Inc. Post Office Box 107 Alvion, Indiana 46701 Mr. Boris Osheroff Interim Principal Environmental Offices for Health Parklawn Building, Room 17A-43 5600 Fishers Lane Rockville, Md. 20852 S Mr. Radford and Wandrel Attorney at Law Post Office Box 223 ' Bedford, Virginia 23523 BOR 004868 i Mr. Gerald Kessler Secretary-Treasurer Kessler Products Company, Inc. 302 McClurg Road Box 389 Youghstown, Ohio 44501 Mr. Gerard R. Quinn Vice President U-Brand Corporation Clark Street Ashland, Ohio 44805 Mr. John L. Satterfield New Products Manager Americhem, Inc. 2038 Main Street Cuyahoga Falls, Ohio 44221 Mr. Chris Seibel Junior Vice President Posh Chemical, Inc. 17 Matinecock Avenue Port Washington, New York 11050 Mr. Paul A. Korody, Jr. Director of Governmental Affairs The National Association Food 1725 Eye Street, N.W. Washington, D.C. 20006 Mr. Morton F. Guerlne Executive Vice President/ General Manager Geauga Plastics Company 900 South Wiley Street Crestline, Ohio 44827 Mr. Harry J. Lambeth Kothe, Eagleton, Barton and Lambeth 632 Shoreham Building 806 Fifteenth Street, N.W. Washington, D.C. 20005 Mr. H. M. Basow Kreonlte, Inc. 715 East 10th Street Post Office Box 2099 Wichita, Kansas 67201 Mr. Stephen B. Bogese President Virginia Plastics Company Post Office Box 165 Roanoke, Virginia 24002 Mr. John E. Sloat Technical Director L. Frank Markel & Sons, Inc. Norristown, Pennsylvania 19404 Mr. Leonard H. Devenow Director of Procurement Sheller-Globe Corporation Toledo, Ohio 43624 Mr. Jack C. White President Tridyn Industries, Inc. Post Office Box 156 Colfax, North Carolina 27235 Mr. Frank D. Gaus President Superior Products Cosq>any, Inc. 833 47th Avenue Oakland, California 94601 Mr. Richard Douslas, Jr. President FEP Industries, Inc. 6115 Robertson Avenue Nashville, Tennessee 37209 Mr. W. D, Lovett Development Engineer Calgon Corporation Post Office Box 1346 Pittsburgh, Pennsylvania 15230 Mr. M. Martin Maglio Executive Vice President PCI Industries, Inc. Post Office Box 9845 Riviera Beach, Florida 33404 Mr. H. M. Zimmerman Director of Manufacturing A. Schulman, Inc. 3550 West Market Street Akron, Ohio 44313 w ^, BOR 004869 Mr. Addison Hawley President United States Concrete Pipe Company and Sedco Corporation Post Office Box 6982 Cleveland, Ohio 44101 Mr. William P. Miller, Jr. Johnson Plastic Corporation Post Office Box 100 Munn and Stafford Road Chagrin Falls, Ohio 44022 Mr. John Steven Harris Chairman of the Board American Plastics Balnbridge, New York 13733 Mr. R. F. Williams, Sr. Chairman Genova, Inc. 300 Rising Street Davison, Michigan 48423 Mr. Nelson E. Schmidt 39 South LaSalle Suite 1500' Chicago, Illinois 60603 Mr. Phillips Covington and Burling 888 Sixteenth Street, N.W. Washington, D.C. 20006 Mr. Robert Homel Assistant General Counsel Boise Cassett Corporation One Jefferson Square Boise, Idaho 83701 Mr. John E. Sloat Apartment B-406 251 W. Dekalb Pike King of Prussia, Pennsylvania 19406 Mr. Etcyl H. Blair Director of Health and Environmental Research U.S. Area Research and Development Dow Chemical U.S.A. 2020 Dow Center Bennett Building Midland Michigan 48640 Mr. Joseph T. Flanagan Technical Consultant The Hartford Insurance Group Loss Control Department - ESU Hartford Plaza Hartford, Connecticut 06115 Mr. W. M. Laughton Standards Section Engineering Assurance Stone and Webster Engineering Corporation Post Office Box 2325 225 Franklin Street Boston, Massachusetts 02107 Mr. R.J. O'Leary General Manager Plastic Film Department Allied Chemical Corporation Post Office Box 1057R Morristown, New Jersey 07960 Mr. Eugene Ritchie Ray Josephs 230 Park Avenue New York, New York 10017 Shell Development Company Library Biological Sciences Research Center Post Office Box 4248 Modesto, California 95352 Mr. G. E. Westerlund Facilities Engineering The Okonite Company Post Office Box 340 Ramsay, New Jersey 07446 Mr. Harlan Bentzinger Chemical Products King Philip Road East Providence, Rhode Island 02914 Mr. Thomas G. Riley Goodyear Tire arid Rubber. Co. Manager of Public Relations 812 National Press Building Washington, D.C.' 20004 * BOR 004870 I Private Industry Mr. H. B. Allick Goodyear Tire and Rubber Conq>any 5408 Baker Avenue Nlagra Falls, New York 14302 Mr. Marshall Miller Reavls, Pogue, Neal and Rose 1100 Connecticut Avenue, N.W. Washington, D.C. 20036 Mr. Fred Sacks Diamond Shamrock Technical Center Post Office Box 191 Painesville, Ohio 44099 Mr. Jon Heider Law Department Air Products and Chemical, Inc. Five Executive Mall Wayne, Pennsylvania 19087 Mr. George Coling APHA 1015 Eighteenth Street, N.W. Washington, D.C. 20036 Mr. J. T. Moore, Jr. President Moore Chemical Corporation Post Office Box 34184 San Francisco, California 94134 Mr. R. Craig Andrews Counsel Diamond Shamrock Chemical Corporation 1100 Superior Avenue Cleveland, Ohio 44114 Mr. F. V. Prus Vice President The Goodyear Tire and Rubber Company Akron, Ohio 44316 Mr. William C. Becker Assistant General Counsel The B. F, Goodrich Company 500 South Main Street Akron, Ohio . 44318 Mr. L. H. Bingham President Gaspro, Inc. Post Office Box 2454 Honolulu, Hawaii 96804 Mr. R. 0. Kittredge President Fabri-Kal Corporation 3303 East Cork Street Kalamazoo, Michigan 49001 Mr. B. W. Smith, Jr. Vice President Olin Corporation 120 Long Ridge Road Stamford, Connecticut 06904 Mr. John W. Swanson Cities Service Conq>any Post Office Box 300 Tulsa, Oklahoma 74102 Mr. David A. De Ghetto Manager Carlon Three Commerce Park Square 23200 Chagrin Boulevard Cleveland, Ohio 44122 Mr. Harold A. Wagner Vice President Harvel Plastics, Inc. Post Office Box 757 Easton, Pennsylvania 18042 Mr. Saul Goldstein President Lyncor Plastics Corp. Two Brookline Street Lynn, Massachusetts 01902 Mr. Zvi R. Cohen President Prevue Products, Inc. 195 McGregor Street Manchester New Hampshire s03120 BOR 004871 Mr. Willard Smith Economic Analysis Division Office of Planning and Evaluation Environmental Protection Agency Room 3009, Waterside Mall 401 M Street, S.W. Washington, D.C. 20460 BOR 004872 Department of Libor Oanlal t. Boyd, Ph.D. Dlraetor Offlca of Standard* Development U.S. Department of Labor, OSHA Boon 610, 1726 M Streat, N.W. Washington, D.C. 20210 Mr. Edward Klein Office of the Solicitor U.S. Department of Labor 14th 6 Conatltutlon Avenue, N.W. Waahlngton, D.C. 20210 Mr. Ray McClure Office of Compliance Programing U.S. Department of Labor, OSHA Room 760, 1726 M Street, N.W. Waahlngton, D.C. 20210 Mr. Benjamin L. Mintz Offlca of the Solicitor U.S. Department of Labor Room 5420, Main Labor 14th & Conatltutlon Avenue, N.W. Waahlngton, D.C. 20210 Dr. John P. O'Neill Office of Standards Development U.S. Department of Labor, OSHA Room 660, 1726 M Street, N.W. Waahlngton, D.C. 20210 Mr. John E. Plummer Associate Assistant Secretary for Administrative Programs U.S. Department of Labor, OSHA Room 1100, 1726 M Street, N.W. Washington, D.C. 20210 Mr. Eugene Regad, Jr. Offlca of Standards Development U.S. Department of Labor, OSHA Room 660, 1726 M Street, N.W. Waahlngton, D.C. 20210 Mr. Howard Sehulta Deputy Assistant Secretary U.S. Department of Labor, OSHA Room 2116, Main Labor 14th & Constitution Ave.,N.W. Waahlngton, D.C. 20210 Mr. John H. Stender Assistant Secretary for Occupational Safety and Health Administration U.S. Department of Labor Room 3115 14th & Constitution Ave.,N.W. Washington, D.C. 20210 Mr. Barry S. White Associate Assistant Secretary for Regional Programs U.S. Department of Labor, OSHA Room 620 1726 M Streat, N.W. Washington, D.C. 20210 BOR 004873 Ml. M. Poepur HEW North Building 300 Independence Avenue, S.W. Boon 37U Washington, D.C. 20201 Mercua M. Key, M.D. Director, National Institute for Occupational Safety and Health Department of Health, Education, and Welfare 12420 Parklawn Drive DANAC Building Rockville, Maryland 20852 Mr. Vernon Rose Office of Research and Standard Development National Institute for Occupational Safety and Health 12420 Parklawn Drive DANAC Building Rockville, Maryland 20852 Mr. Gene Proctor Occupational Medicine and Environmental Health NASA, 600 Maryland Avenue, S.W. Washington, D.C. 20546 Mr. William C. Salmon Deputy Director Office of Environmental Affairs State Department Washington, D.C. 20520 Mr. Stanley D. Allen Chief, Management Analysis Division Office of the Secretary Department of Treasury Washington, D.C. 20220 Mr. W. J. Burns Director, Office of Hazardous Materials Department of Transportation Washington, D.C, 20590 Mr. Martin Convlasar Director Office of Envlronnmntal Quality Office of the Secretary Department of Transportation 400 Seventh Street, S.W. Washington, D.C. 20590 Deputy Secretary of the Treasury Treasury Department 15th & Pennsylvania Ave., N.W. Washington, D.C. 20220 Mr. Walter J. Barrows Landscape Coordinator Parks Department 501 Poll Street Ventura, California 93001 Mr. Barry H. Lockton Director of Public Works 107 North Venture Street OJai, California 93023 Mr. J. L. Wootan Environmental Program Specialist II Occupational Health Planning Project Oklahoma State Department of Health N.E. Tenth & Stonewall Oklahoma City, Oklahoma 73105 Ms. Williams Office of Environmental Affairs Department of Commerce Room 3425 Washington, D.C. 20350 Mr. S. A. Leone DBER Room E-201 U.S. Atomic Energy Commission Washington, D.C. 20545 \ BOR 004874 Governmental Agencies Colonel Herbert E. Bell Headquarters 0>AT (Prev) Washington, D.C. 20330 T. C. Byerly, Ph.D. Coordinator Environmental Activities Department of Agriculture Room 312-E Washington, D.C. 20250 Colonel John E. Ward Occupational Health Consultant Office of the Surgeon General Department of the Army Forrestal Building, Room B207 Washington, D.C. 20314 Mrs. Grlffltts Joint Medical Library Office of the Surgeon General Forrestal Building, Room 6E040 Washington, D.C. 20314 Mr. M. B. Biles U.S. Atomic Energy Consolsalon Washington, D.C. 20545 Mr. Robert J. Catlln Division of Environmental Affairs U.S. Atomic Energy Commission Washington, D.C. 20545 Mr. W. H. Pennington Division of Environmental Affairs U.S. Atomic Energy Coned.ssion Mr. Julius Ruben Assistant General Manager of Environment and Safety U.S. Atomic Energy Commission Room A303 Washington, D.C. 20545 Sidney R. Geller, Ph.D. Deputy Assistant Secretary Envlronsmntal Affairs Department of Comserce Washington, D.C. 20230 Dr. Warren Muir Council on Environmental Quality 722 Jackson Place, N.W. Washington, D.C. 20575 Mr. David Roase Materials Division-Chemicals Department of Comnerce 14th and E Street, N.W. Washington, D.C. 20230 Mr. George L. Feazall Director of Safety Policy Department of Defense The Pentagon Washington, D.C. 20301 Sheldon Meyers, M.D. Director of Federal Activities Environmental Protection Agency Waterside Mall Building Room 535, 4th & M Street, S.W. Washington, D.C. 20460 Mr. Pope Laurence Environmental Protection Agency Waterside Mail Building Room 535, 4th & M Street, S.W. Washington, D.C. 20460 Mr. Peul Cromwell Acting Chief Environmental Officer Department of Health, Education and Welfare Room 3718N 300 Independence Avenue, S.W. Washington, D.C. 20201 BOR 004875 appendix d DISTRIBUTION LIST FOR FINAL ENVIRONMENTAL IMPACT STATEMENT S BOR 004876 -3Worker exposure to vinyl chloride can occur at VCM plants, PVC plants, and at plants which fabricate the PVC into plastics. The greatest number of workers exposed and the greatest economic impact of vinyl chloride regulation would occur if the plastic fabri cation facilities were severely impacted. If, as we expect, your proposed standard will result in very low VCM residuals in the resins produced at PVC plants, they will probably cause no detectable exposure to workers in plastics fabrication plants and eliminate the need for any additional action by the plastics manufacturers. In this event, the economic impact of your regulations would be limited to the relatively few VCM and PVC manufacturers. The Council is convinced that OSHA's proposed standard is both necessary and feasible. We encourage you to pursue it. We look forward to receiving your final impact statement and remain available for consul tation at any time. Sincerely Dr. Daniel Boyd Director, Office of Standards Development Occupational Safety & Health Administration Room 610, 1726 M Street, N.W. Washington, D.C. 20210 BOR 004877 2- - We wrote the Manufacturing Chemists Association (MCA), sponsors of the T-C Associates study, for additional information, but only part of the data we requested was supplied. We were informed that the remainder will not be forthcoming. We are concerned that this industry has not seen fit to supply this important data. Thus, while the T-C Associates study shows excess cancers due to vinyl chloride it by .design vastly underestimates the rate, and analyses to correct this deficiency will not be conducted. Similarly, the Industrial Bio-Test data shows angiosarcomas in animal feeding studies at 50ppm VCM. This data is very preliminary since few animals had full pathological examinations and the study group was reduced by an unspecified number due to cannibalism. So, while the study tends to confirm carcinogencity and the preliminary findings of Professor Maltoni, a complete analysis of the data when the experiment is run full-term is likely to show a very substantially higher rate of malignancies. Based on our review of the draft EIS and other available information, we strongly believe that an occupational standard, such as that proposed, which affords workers no detectable level of exposure to vinyl chloride, is necessary. The vinyl chloride issue, however, is more than just an occupational health concern. It is also a consumer and environmental concern. In order to eliminate risks to consumers from vinyl chloride entrapped in polyvinyl chloride plastic products and in order to prevent environmental exposures from air and water pollution emissions from VCM, polyvinyl chloride (FVC), or plastics plants, it is clear that industrial process changes are required. The proposed standard would make such changes necessary and, we believe, wou]d substantially improve environmental levels of vinyl chloride outside the plant. N BOR 004878 EXECUTIVE OFFICE OF THE PRESIDENT COUNCIL, on environmental, quality 722 JACKSON PLACE. N. W. WASHINGTON. 0. C. 20006 MG 5 1974 Dear Dr. Boyd: The Council has received and reviewed OSHA's Draft Environmental Impact Statement (EIS) on Proposed Regula tion of Vinyl Chloride. We note with approval that the proposal upon which the EIS is based is fully articulated in the statement. We encourage this approach in the future and expect it to be followed in the case of each final impact statement. Much additional information concerning the health risk from vinyl chloride exposure has become available since the draft EIS was filed. This includes industry supplied epidemiological data from Tabershaw-Cooper (T-C) Associate's, preliminary animal feeding study data from Industrial Bio-Test, and the report of angiosarcomas potentially resulting from environmental exposures in plastic fabrication plants. This new data should be included in the final EIS. It will strengthen the already compelling case for the strong standard OSHA has proposed. Although we encourage incorporation of the Tabershaw-Cooper Associates study and the Industrial Bio-Test data in the final EIS, we are concerned that some interpretations of these studies might understate their findings. The T-C study covers some 8,000 workers with a history of exposure to vinyl chloride. It reports elevated incidents of several types of cancer, but it provides only a grossly underestimated incident rate over the expected rate because a very large fraction of the workers studied were not exposed to VCM long enough ago to show cancers that will develop after the latency period characteristic of all chemical carcinogenesis. "v BOR 004879 of worker exposure may be even more serious than previously believed. Finally, the draft quotes us as saying that some 700,000 workers are seriously exposed in this country. Indirect data, a study of the industry in Japan, would indicate that our estimate is grossly in error and that the actual population at risk is in the order of 1.5 million. Respectfully submitted, She 1 don W. Samuels Director Health, Safety and Environment Attachment SWS:aek opeiu#2 BOR 004880 i rJ D U O T n! A L U LMIO ^ DSPARTr/iEE^T A F L-C I O 015 Sixteenth Street. N W.. Washington. D.C. 2000C Area Code 202 393-5581 I. W. Abel. President Jacob dayman. Secretary-Treasurer August 5, 1974 Dr. Dan Boyd, Director Office of Standards and Development Occupational Safety and Health Administration 1726 M Street, N. W. Washington, D. C. Dear Dr. Boyd: Enclosed is a detailed comment on the draft environmental impact statement for the proposed regulation of vinyl chloride. A general comment on the statement is In order. First, if economics must be considered, then micro-economic cost/benefit analyses are grossly inadequate. Second, the full range of effects to be considered include those which are not quantifiable and those which lie entirely out of the normal discourse of even macro-economics. In addition, we wish to denote that our comment cannot take into account two new lines of evidence: teratogenic and genetic effects noted at the NIEHS meeting last week by Dr. Irving Selikoff and the additional case of angiosarcoma identified by thr NIOSH epidemiological study of B. F. Goodrich's Louisville plant. Evidenced by death certificate data (an autopsy was performed at death), James W. E. Howard becomes the 16th vinyl chloride-related angiosarcoma case found in the United States and the 8th at the Louisville plant. Mr. Howard died on March 27, 1969 at the age of 42. He worked for B. F. Goodrich for four and one-half years in the early 1950's and spent only nine months on the polymer ization operations there. This case is especially distress ing because of the short period of exposure to vinyl chloride ancl, in concordance with the increasing numbers of cases being found worldwide among fabricators, suggests tliat the problems VICE rnESIIICNTS Purer V ilier ! Hu ku ->o! O Ch.iir.m IVr i Hu,*.! Mu* ('wiOorj M iU't. .v m IG\)iUl' loJ'i"t.MJuinwOclki ( 'lAiiv. fr'llllkf l It.iuy II Po<;ln !, r lank n.tiiiM/ A Philip Randolph *V Vuiitto Heed RoMnd Roiciy So. l-n Ju&eph f* Tonrlll Sh.'truiun J. Wfih C.lnnn Wmi'i ('!,WeN of BOR 004881 RICHARD FLEMING CROUP Vice PRCSIDLNT-CHIMIC Al S CHEMICALS GROUP Five Executive Mall. Swedesford Road, Wayne, Pa. 19087 August 5, 1974 Telephone: Telex: (215) 087-6150 846-445 Mr. David R. Bell Occupational Safety and Health Administration Office of Standards Development Room 500 1726 M. Street N.W. Washington, D.C. 20210 HAND DELIVERED Re: Draft Environmental Impact Statement Proposed Regulation _Vinyl Chloride Dear Mr. Bell: Air Products and Chemicals, Inc. submits herewith its comments on the Draft Environmental Impact Statement ("Draft") - Proposed Regulation Vinyl Chloride. In addition to the comments contained herein, we incorporate by reference the testimony of Richard Fleming, John T. Barr and Dr. Paul Kotin, M.D. on behalf of Air Products which is found at pp. 781-857 of the Official Report: of Proceedings (hereinafter cited as "Official Report") before the Occupational Safety and Health Administration ("OSHA") of the U.S. Department of Labor in the matter of Proposed Permanent Standard for Occupational Exposure to Vinyl Chloride (Attached hereto as Exhibit A). This pro cedure is in accordance with the statement made by Dr .v Daniel P. Boyd, Director of the Office of Standards Development BOR 004882 for OMRA (pp. 1110-11 of the Official Report). Also in corporated by this reference arc our detailed continents on the proposed standard itself which have previously been submitted to OSHA and made part of the Official Report as Exhibit 23-B. (Attached hereto as Exhibit B.) 1. INTRODUCTION The National Environmental Policy Act ("NEPA") requires that every major federal action, such as the promulgation of the proposed standard for vinyl chloride, be preceded by detailed statement on (i) the environmental impact of the proposed action, (ii) any adverse environmental effects which cannot be avoided should the proposal be implemented, (j.ii) Alternatives to the proposed action, (iv) the relationship between local short term uses of man's environment and the maintenance and enhancement of long-term productivity, and (v) any irreversible and irretrievable commitments of resources which would be involved in the proposed action should it be implemented. Preliminarily we would like to note that the Draft goes far beyond the scope of its purpose as specified by NEPA. S Wo note this point for two reasons: (1) our comments will -2- BOR 004883 be restricted to responses relative to assertions made by OSHA which are pertinent to the purpose of the Draft as outlined above; and (2) we would hope that in the final Statement, OSHA will restrict its observations and remarks to those areas relevant to NEPA. In this manner we believe that those individuals directly involved in reducing employee exposure to vinyl chloride can avoid wasting the time and effort involved in refuting irrelevant, but erroneous, remarks such as those contained in the Draft. Thus, while there are substantial errors, mis-statements and omissions in Sections 1 through IV of the Draft, we do not believe these Sections are at all pertinent, and should be deleted in their entirety. We will confine our comments to Sections V through VIII which are the Sections mandated by NEPA. With respect to Section V dealing with the Standard as proposed, we will merely reference our detailed comments which are attached as Exhibit B. As a general comment applying to practically every Section of the Draft, it must be emphasized at the outset that much of what is contained in the Draft is in error because the underlying assumptions arc erroneous. One erroneous assumption is that technology exists which will meet the nodetectable level of the proposed Standard. This is simply not the care. The underlying erroneous assumption is somewhat explained by the fact that OSHA did not make any technological - 3- BOR 004884 or feasibility studies prior to the time the Draft was prepared. This fact was pointed out by Dr. Boyd. (See pages 1110 and 1132 of the Official Report.) We cannot help but comment that the issuance of this draft statement, based as it is on largely unfounded assumptions and expressing viewpoints far beyond any valid purpose of the document is indeed lamentable. It is to be hoped that in the future OSHA will take a much more responsible and factual approach before making documents of this kind public. Promulgating misinformation is hardly a function of OSHA. I1. Comments on Sections VI. Probable Impact of the Proposed Standard 1. The Draft states that one major impact of the proposed standard would be a workplace environment free of the "known hazards" of vinyl chloride exposure (p. 60). The uncontradicted testimony adduced at the hearings, however, was to the effect that it is technologically impossible to meet the "no detectable level" required by the proposed standard. Indeed, Dr. Maircus Key of NTOSH testified that it was not his impression that a non-detectable level of vinyl ch3ori.de could be achieved (p. 131 of the Official Report). The major impact of the standard would, therefore, be the complete shutdown of the VCM/PVC industry with its attendant economic and social disruptions. -A - BOR 004885 Moreover, since the standard, in effect, sets a level of 1 part per million, one would assume that levels above that constitute "known hazards" of vinyl chloride. But the hazards to humans of exposure to vinyl chloride are "known" only in relation to high concentrations over long periods of time. (See the chart of the estimated levels of exposure of those PVC workers who have died of angiosarcoma which is attached hereto as Exhibit C.) It is not known that exposure to 50 ppm VCM constitutes a hazard to man. In fact, the most authoritative human toxicological study done to date demon strates no adverse medical effects related to continuous long term exposure to concentrations of vinyl chloride up to 200 parts per million. (See pages 932 et. seq. of Dow testimony in the Official Report.) Therefore, it would be a true statement to assert that the temporary standard of 50 ppm would create a "workplace environment free of the known hazards of vinyl chloride exposure." 2. Even though it is technologically impossible to achieve the level of vinyl chloride concentration mandated by the proposed standard, it is possible to achieve average levels lower* than the 50 ppm provided for in the Temporary Emergency Standard. Meeting these levels will also cause the impact of substantial additional capital and other operating costs which OS1IA states (page 60) industry will incur in -5- BOR 004886 attempting to meet the proposed standard. The degree of this impact will be governed in part by the reasonableness of the final standard and in part by the time frame during which compliance is mandated. 3. While it is true that vinyl chloride is a petro chemical produced from irreplaceable natural resources, diminished production of vinyl chloride and polyvinyl chloride would only increase the demand for ABS, poly ethylene and other plastics similarly derived from petrochemicals. The proposed standard would not, therefore, reduce the total demand for such irreplaceable natural resources. Moreover, petrochemical production accounts for less than 5% of the use of petroleum in the United States; the remaining 95+% is burned as fuel, producing heat and carbon dioxide. Rather than discourage petrochemical production, the policy of the United States should be to encourage the shift in petrochemical usage from fuel to durable products such as polyvinyl chloride, while more plentiful resources such as coal should be used for fuel. 4. Implementation of the proposed standard would affect the working environment of the estimated 1,500 workers engaged in monomer production, 5,000 in PVC resin production, and others in processing and fabrication. The AFL-CIO estimate of 700,000 exposed workers is too high, however, since the - 6- BOR 004887 proposed standard does not purport to apply to tertiary production. A shutdown of the entire industry would, however, have an adverse economic and social impact on at least the 700,000 workers cited in the AFL-CIO estimate as well as tens of thousands more in jobs that depend on polyvinyl chloride products. A study by A. D. Little concluded that between 1.7 million and 2.2 million workers could lose their jobs if vinyl chloride and PVC production terminated immediately. (Page 456 in the Offical Report.) 5. The Draft is too casual in its analysis of the decline in productivity that would result from implementation of the proposed standard. Work practice changes will have a significant adverse impact on worker productivity, and personal protective equipment (e.g. respirators) of the type proposed will result not only in decreased productivity, but more importantly will in themselves constitute a safety hazard due to decreased vision, mobility and oral communication and increased fatigue and psychological distress. (See pp. 88 and 307-16 of the Official Report.) 6. The statement at the bottom of page 62 of the Draft that "a preliminary assessment of the cost of compliance indicates that the expenditures required will not be pro hibitive" is preposterous and totally refuted by the fact \ that OSllA has made no study whatever to support this statement. Moreover, the testimony of the companies affected, the only -7- BOR 004888 knowledgeable people to comment on this, is quite to the contrary. See, e.g. the testimony of Tenncco Chemicals, Inc. at pp. 694-95 and the Firestone testimony at pp. 169899 of the Offical Report. The steps which industry has already taken to reduce VCM exposure are described at the top of page 63 of the Draft, but the last sentence of that paragraph stating that technology is readily available to meet the proposed level without substantial developmental costs is without foundation. As testified by Air Products at pp. 790-91 of the Official Report, "Everyone has obviously done the quickest, easiest, most effective things first." Existing technology and improved work practices have been utilized to bring the VCM level as low as possible; further reductions in the VCM level must await new technology and/or the installation of new equipment. As was stated throughout the OSHA hearings on the proposed standard, there is no known technology to achieve the standard. Since the technology is not available, development will require substantial expenditures of time and money without any degree of certainty as to the achievable levels. Indeed, as was pointed out in Tenneco's testimony, they estimate that they will spend approximately 10 million dollars (plus millions in additional operating costs) attempting to attain a TWA level of 10 ppm by 1976. (p. 694 in the Official Report.) Firestone estimated that botween^SO and 55 million dollars would be required in attempting to reach a non-doteetable level, (p. 1699 in the Official Report.) 8 BOR 004889 7. Contrary to the last sentence on page 63 of the Draft, promulgation of the proposed standard will most certainly stop vinyl chloride production and polymerization in the United States. It is impossible to retrofit existing polymerization plants to meet the proposed standard, and APCI has estimated the cost of replacing its present capacity with a new PVC plant at approximately $30 million. Since this estimate was determined in 1973, the same plant would cost considerably more because of inflation. We do not believe, however, that a new plant will meet the no detectable standard. To propose as on page 63, that, improvements in housekeeping and main tenance schedules will permit meeting the standard shows a degree of naivete about the difficulty of the proposed standard that is incredible. 8. The only discussion of the adverse environmental .impact of the proposed standard occurs in the middle of page 64 of the Draft. Not discussed, however, are other adverse effects. For example, there was testimony at pp. 202-03 of the Official Report concerning the use of PVC conveyor belting in the crucial industries of coal mining, grain handling and food processing. A shortage' of PVC belting in the coal mining industry would have disastrous consequences for this nation's energy policy. \ Among other adverse impacts resulting from the proposed standard which readily came to mind are the following. Any 9 BOR 004890 reduction in PVC, for example, will reduce the demand for chlorine; since caustic soda is produced simultaneously with production of chlorine, caustic soda products will be reduced by about 20%. The adverse impact of lower caustic production will be evident in the paper, aluminum, pollution control fields and many others. In addition, as a non-flammable wire coating, PVC is virtually irreplaceable for a number of applications. 9. The Draft states on page 64 that one of the likely methods of approaching compliance with the proposed standard will be in the form of improved ventilation into the atmosphere for dilution and dispersal. It seems pertinent to comment that following control of vinyl chloride losses from the equipment wherever possible, the primary engineering control to reduce vinyl chloride monomer concentrations in the working atmosphere is the ventillation of vinyl chloride laden air to the atmosphere. No feasible method other than ventilation is now known. It must be stated, therefore, that controls on atmospheric ventilation by the EPA, or other governmental agencies will have an interlocking impact along with OSTIA regulations on vinyl chloride monomer and polyvinyl chloride industry. There was testimony at the hearing from Calgon Corp. concerning the adsorption of VCM on activated carbon.N (The - 10 - BOR 004891 word "filtration" is a misnomer since it is impossible to filter a gas from a gas.) Calgon had no practical or technical suggestions as to how the ambient air in a PVC or VCM plant could be moved in such a way as to pass through a bed of activated carbon. Even if Calgon's activated carbon technology could effectively remove VCM from an airstream, the evidence clearly shows that its use would be primarily directed to the reduction of emissions to the atmosphere, and not to solving the problem of in-plant worker exposure to VCM. HI. Comments on Section VII. Relationship to Other Federal Action Our comments here are limited to our previous statements to the effect that, action by one agency, sucli as the EPA in limiting VCM emissions, would increase worker exposure to VCM. Wc eurmol help but also comment, however, that the report on page 66 of the Draft concerning retention of all but 1% of vinly chloride in a room for four days is sheer nonsense. IV. f,_on Section VIII Alternatives 1. It is submitted that OSHA does not have the authority to ban the production of vinyl chloride. (See IUD, AFL-C10 v. Hodgson, April 15, 1974, U.S. Ct. of Appeals, D.C. Cir.) lhe first alternative is therefore not viable. - 11 - BOR 004892 2. Since the practical effect of a zero exposure level is equivalent to a ban on vinyl chloride, it is submitted that the second alternative is likewise not viable. Given the inevitability of vinyl chloride leaks, the only conceivable method of complying with a zero exposure level would be by continuous use of respirators. As noted at pp. 88 and.307-16 of the Official Report, such continuous use of respirators would in itself constitute a safety hazard and prove impractical. 3. It is unwise to dismiss summarily the third alternative providing for retention of the 50 ppm level prescribed by the Temporary Emergency Standard. While it is true that mice have developed angiosarcomas at 50 ppm, the translation of this data cannot be directly related to human experience. Moreover, the testimony of Dow Chemical referenced above and the medical testimony of Air Products (pp. 805-12 of the Office] Report); SPI (pp. 500-14 of the Official Report) Diamond t'- L . (pp. n--i-1040 of the Official Report) and others give great credibility to the position that 50 ppm will not. create adverse medical effects. 4. While V7c agree that reliance on personal protective equipment cannot be th^ sole source of protection, setting a ceiling level requires that such equipment be permitted when the coiling is exceeded. Since it is impossible to avoid occurs i ona 1 excursions above any given level., use of protective equipment on those occasrions are the only means; of protecting the employee. - 12 BOR 004893