Document Jr4MMr3Xy2e9bzvXxxmb0kV2Z

RECEIVED JUL 181974 SAFETY AND PLANT PROTECTION "'for. -"Lv V> SUMMARY OF TESTIMONY BY UNIROYAL, INC. IN OBJECTION TO THE PROPOSED PERMANENT STANDARD 1910.93q RELATING TO VINYL CHLORIDE EXPOSURE DOCKET OSH-36 URL 16695 June 21, 1974 INTRODUCTION p. 1 Of 3 SUMMARY OF TESTIMONY BY UNIROYAL, INC* IN OBJECTION TO THE PROPOSED PERMANENT STANDARD 1910.93q RELATING TO VINYL CHLORIDE EXPOSURE I an Martin J. Kleinfeld, Commercial Planning Director of the Chemical Division of Uniroyal, Inc* I am a chemist and tor nine years, from 1948 through 1956, I was involved in research and development and manufacturing of vinyl chloride and polyvinyl chloride resins. In subsequent years 1 have been successively Marketing Manager and Research and Develop-* sent Manager for Uniroyal's PVC resin operations* My associates are Dr* Walter Harris, Corporate Toxicologist; Mr* Benton Leach, Factory Manager of our Painesville, Ohio polyvinyl chloride manufacturing facility and Mr. Richard Weller of Arthur, Dry & Kalish, our legal firm* Uhixoyal has been in the business of manufacturing vinyl chloride monomer and polyvinyl chloride resins for 27 years* We are one of the world's major manufacturers of vinyl products such as coated fabrics (under the trade name of Naugahyde) and have been for 33 years. While we were the third producer of polyvinyl chloride in the U.S* we have not expanded as rapidly as some and currently account for only about 3 percent of the total U.S. production. It is noteworthy, however, that with only 3 percent of the total production and about 300 people directly involved in the manufacture of these resins we affect about 25,000 employees in customers* fabricating operations dependent at least in part upon our resins. A simplified extrapolation of this ratio for the industry would suggest that as many as 800,000 employees could be adversely affected by a major cut-off of the polyvinyl chloride supply; and this does not, of course, account for the hundreds of thousands of (CONTINUED) 9699 nun INTRODUCTION p. 2 of 3 workers whose Jobs would be affected by a stoppage in the flow of fabricated products which are dependent upon polyvinyl chloride and not amenable to near future substitution of other materials, many of which are also in short supply as a result of the energy shortage. As mentioned, our plant at Painesville, Ohio has been in continuous commercial operation for 27 years. During the first 14 years of operation we also produced vinyl chloride monomer at the same site. During these 27 years we have pro* duced over 1.5 billion lbs. of PVC and have employed about 800 people in this plant during this period. 150 of these have worked in close proximity to the VCM/FVC operation for over 16 years; 56 of these for over 25 years. The medical data we have accumulated to date have disclosed no incidence of angiosarcoma and the incidence of abnormal liver function test results appears to be no greater than in the general population. We are submitting to the OSHA at this time our written detailed discussion of our objections to the Proposed Standard; 19 are enumerated in our submittal. In the interests of conserving time I will highlight now only those points which we believe are of greatest importance relative to safety considerations and the economic impact of the Proposed Standard. A. Objections to Specific Portions of Proposed Standard 1) Our major objection is to the **no detectable level11 restriction. This has been detailed in our EXHIBITS A-l, A--2, A-3, A-7, A-g and A-17 following. 2) We do not see the need for special protective clothing as we are unaware of any evidence that has proven a medical risk due to skin absorption of vinyl chloride gas. (See EXHIBIT A-6) 3) We believe the respiratory section should be written with more flexibility to allow the use of a greater variety of respirators based upon their proven ability to cope with the situation at hand. (See EXHIBIT A-il) (CONTINUED) URL 16697 INTRODUCTION p. 3 of 3 )4 "Emergency" situation by definition should be con fined to release of large quantities of vinyl chloride* (See EXHIBIT A-4) 5) The mandatory requirement for removal of personnel from potential vinyl chloride contact areas if upon medical fescreening one or more abnormal liver function tests persist, leaves the examining physician no room for judgement. Furthermore, removal of an employee to an area with '*no detectable level" of vinyl chloride, which in our opinion, is unlikely to be found consistently in the vicinity of a vinyl chloride or polyvinyl chloride plant, would appear to leave no alternative but transfer or dismissal* (See EXHIBIT A-16) ** URL 16698 .EXHIBIT A-l p, 1 of 2 Summary of Objections to Specific SectiOTSOf^oposedStandardieiO^Sq URL 16699 Section: (a) Scope and application (1) and (2) Objections Application to all areas where "detectable** levels are released. Inclusion of polyvinyl chloride containing "detectable" amounts of vinyl chloride. Grounds and/or Suggested Changes: Occupational health evidence does not warrant imposition of this Standard on all workplaces where a "detectable" level of vinyl chloride may be present. A "non-dec-table" re striction is technologically infeasible in vinyl chloride monomer and polyvinyl chloride production plants. Some permitted level which has not been proven unsafe must be allowed in workplaces to avoid shut down of a major industry with the resultant severe effects upon both labor, i.e. loss of jobs, and our national economy. There is no proven risk or any reasonable expectation of any medical risk from trace amounts of residual vinyl Chloride in polyvinyl chloride in processing plants, i.e. fabricators. Further assurances of freedom from risk can be implemented by restricting the amount of free monomer in the polymer. Inclusion of the many thousands of processing work places under the total restrictions and demands of this Standard is we feel illogical as to need and unduly repressive as to cost and utilization of manpower. Ample precedent regarding exclusion of products containing trace amounts e.g., 0.1% - of potentially hazardous materials may be found in Part 1910.93c-p, the recently promulgated standards on 14 alleged carcinogens. EXHIBIT A-l p. 2 of 2 V W recommend that (a) (1) be rewritten so that -it applies only to vinyl chloride and polyvinyl chloride production operations. For these operations, the provisions of the Standard would apply in all areas where exposures to con* centrations of vinyl chloride in the workplace air exceed a specified "permissible level". Our definition of per mitted level may be found under (b) (6) (EXHIBIT A-3). We also recommend that (2) (2) be changed to clearly exempt both polyvinyl chloride processing workplaces as well as those workplaces involved in the handling or use of fabricated products from the scope and application of this Standard. URL 16700 EXHIBIT A-2 p. 1 of 1 Summary of objections to Specific . Sections of Proposed Standard 1910,93q Section: (b) (Definitions) (4) (5) Objection: The word "detectable"* Grounds And/or Suggested Changes: For reasons previously stated, we consider a no detect* able level is an untenable concept. We suggest that "contaminated" be redefined to mean "capable of releasing any amount of vinyl chloride which would exceed the allowable permissible level", 'Decontamination" should be redefined to mean reduction of vinyl chloride concentrations to less than permissible levels. URL 16701 EXHIBIT A-3 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section: (b) (Definitions) (6) Objection: The words "detectable level*' and specific definition Grounds and/or Suggested Changes: For reasons previously stated, a no detectable level is con sidered an untenable concept. We propose to substitute the term "permissible level" for "detectable level". However, establishment of a single, fixed, numerical, permissible level to be met immediately and to cover all operations within the FVC industry creates a difficult problem for a variety of reasons. Certain monomer plants - because of the nature of the process, age, size, location and other factors - could be expected to operate more easily at a lower level than PVC production units. Individual PVC plants also vary due to some of the same factors as above but also due to process variations, finishing operations, design and other reasons. We do not, however, see any justification for setting different permissible levels for different plants. It would be illogical to imply different levels of toxicity for different plants. Once properly established, one level should be applied to all. Taking all factors into consideration, we feel that within a reasonable period of time the industry could and should achieve compliance with a "permissible level" defined as a maximum airborne concentration of vinyl chloride not to exceed a ceiling of 40 ppm or a TWA (8 hour) concentration of 25 ppm. CHir long range goal could involve reduction of any exposures to values considerably less than our proposed definition of a "permissible level". However, before any major commitments are made to reduce exposures to levels approaching zero we feel that further evidence is required to show that there is more than a minimal health risk to workers exposed to levels covered by our proposed definition. EXHIBIT A-4 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard I91093q Section: (b) (Definitions) (8) Objection: Definition of 'Emergency"* Grounds and/or Suggested Changes: This definition is overly restrictive as it does not quantify what is meant by "release of vinyl chloride"* Standard operating procedures would be used in all cases where a higher than "permissible level" exposures might take place Emergency - and the action to be taken - should be con fined to such instances where release of vinyl chloride was of such magnitude that it would produce acute symptoms among exposed workers* URL 16703 EXHIBIT A-5 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section; (b) (Definitions) (10) Objection: "Semifinished product" Grounds and/or Suggested Changes: Definition needs expansion to include "diced or pelletized stock" made from polyvinyl chloride* URL 16704 EXHIBIT A-6 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section: (b) (Definitions) (13) Objection: Definition of "protective clothing" Grounds and/or Suggested Changes: As stated the definition has no practical meaning* The gaseous nature of vinyl chloride in the ambient air mould require completely impervious clothing for absolute protection. Any requirements involving use of impervious clothing should be restricted to extra ordinary exposure conditions such as emergencies involv ing large spills or massive release of vinyl chloride* URL 16705 EXHIBIT A-7 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910*93q Section: (d) Regulated areas (1) (ii) Objection: Definition of regulated area involving polyvinyl chloride operations* Grounds and/or Suggested Changes: Seasons have previously been stated regarding the need to change "detectable level'1 to "permissible level"* Regarding application to polyvinyl chloride, the regulated areas should be restricted to those operations or activities where vinyl chloride levels in the air may exceed the established permissible level.* URL 16706 EXHIBIT A-s p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 191093q Sections (d) (Regulated areas) (3) Objection: Maintenance of "daily roster"* Grounds and/or Suggested Chanoes: This requirement is neither practical or useful* It is at least a duplication of effort* Current time and work records provide information on each employee regarding his activities and regulated areas* a u s n tjn EXHIBIT A-9 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard__1910.93q Section: (e) Monitoring (1) (2) Objection: Clarity of definitions. Grounds and/or Suggested Changes: For reasons previously stated, ''detectable levels" should be changed to "permissible levels**. The phrase ''confidence level of 95 percent" presumes that adequate monitoring techniques can be developed by someone prior to the effective date of adoption of the Proposed Standard since they are not spelled out in the .Standard, There is also some confusion regarding appro priate monitoring methods as related to personal monitor* ing versus area monitoring or a combination of both technique s * URL 16708 EXHIBIT A.10 p. 1 of 1 Summary of Objections to Specific Sectionf of Proposed Standard 1910.93q Section: (f) Engineering controls and work practice methods Objection; Application and need. Grounds and/or Suggested Chances: This entire section addresses itself to the need for immediate use of engineering controls and methods to reduce airborne concentrations of vinyl chloride to aero. Reasons have been previously stated indicating the infeasibility of the 2ero exposure concept. We recommend that this section be rewritten to recog nise that appropriate controls and practices be implemented to reduce exposures to below the maximum permissible level, and that a time schedule of several years will be required to select, purchase and install the necessary equipment. URL 16709 EXHIBIT A-11 p. l Of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section: (g) Respiratory protection Objection: Definition of allowable respiratory protection devices. Grounds and/or Suggested Changes: Allowable devices all have "self-contained breathing apparatus" as a common denominator. There is no provision for independent use of continuous flow or pressure demand types as described in the Emergency Temporary Standard. There is no allowance for cannister respirators. Full facepiece equipment is mandatory. There should be more flexibility allowed in the choice of respiratory equipment. The use of what is specified can be impractical, cumbersome and hazardous in various typical production activities* Half face masks offer protection without the hazard of restricting visibility* Cannister masks - although shown to have fast breakthrough times at high concentrations of vinyl chloride - may be adequate to give protection at the low levels of exposure which may be expected to be experienced most of the time. This section of the Standard should be general enough to accommodate alternate suitable devices that may now be available - or could come on the market in the near future to provide the protection needed without creating other personal hazards in the workplace. - URL 16710 EXHIBIT A-12 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section* (h) Protective clothing Objection: Definition of proper clothing and removal requirements* Application to polyvinyl chloride* 'Contaminated" clothing. Grounds and/or Suggested Changes: The definition "full-body" implies some type of impervious suit* A demand of this type should apply only to extra ordinary exposure situations* Type of clothing required should fit the particular Job assignment - e.g*, an employee engaged in manual cleaning of a reactor vessel mould require more protection than a supervisor or process control operator Except under very special circumstances there should be no need to remove work clothing except at the end of the work day. No special clothing requirements should be associated with the handling of polyvinyl chloride powder unless such powder is capable of releasing vinyl chloride which exceeds the allowable permissible level in the air. It is difficult to understand why laundering or disposal of "contaminated" clothing is recommended when it is recognized that the volatile nature of vinyl chloride pre cludes the possibility of any significant residual life. URL 16711  Summary of Objections to Specific Sections of Proposed Standard 1910.93q EXHIBIT A-I3 p. 1 of 1 Section: (j) Emergency situations Objection: Definition* Shower requirement. Grounds and/or Suggested Changes: 'Emergency" is defined (Webster) as: 'fan unforeseen combination of circumstances or the resulting state that calls for immediate action.tT In any well run operation involving vinyl chloride there already exists a written operational plan for emergency situations. Small-scale excursions of air concentrations above a permissible level should not be defined as an "emergency situation". A massive release of vinyl chloride would constitute an emergency. This definition should be clarified. Further, (2) (iii), the requirement to shower after any skin contact with liquid vinyl chloride is not techni cally sound due to the rapid volatility effect. URL 16712 EXHIBIT A-14 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section: (k) Signs and labels Objection: Wording of signs and labels. Grounds and/or Suggested Changes: Use of the word "Cancer" on signs and labels creates emotional and irrational fears and morale problems which are not warranted. The use of the word `'Hazardous" plus action-oriented instructions in place of "Cancer-Suspect" would accomplish the desired purpose of this section. The requirement to wear "full impervious air-supplied equipment" is unwarranted and unnecessary. The use of such cumbersome equipment would create a safety hazard to the employee. Adequate protection for special situations can be insured through the use of proper respiratory equipment. In all instances where vinyl chloride levels are within the permissible range there should not be any special requirements regarding signs and labels. No special label requirements should apply to polyvinyl chloride unless a hazardous situation can be reasonably anticipated based on residual vinyl chloride content. Under no circumstances should any polyvinyl chloride product containing under 0.1% vinyl chloride fall under this special labelling requirement. EXHIBIT A-15 p.l of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section; (1) Maintenance and decontamination Objection; Definition of terms: "contaminated" and 'decontaminated"* Requirement involving "whole-body air-supplied impervious suit"* Grounds and/or Suggested Changes: '^Contamination" must be expressed in terms of exceeding a permissible level* "Decontamination" must relate to reducing a level to within the permissible range* How to achieve decontamination is unclear* The "whole-body" suit is objected to for reasons pre viously stated* It must be emphasized that this Proposed Standard is for the purpose of reducing an alleged carci nogenic medical risk* We are unaware of any indictment of vinyl chloride involving such a risk by skin absorption of airborne vinyl chloride* A practical consideration involving "vessel entry" should take into account that many reactors have small manholes which would make it impossible for a person to enter if clothed in the full f,whole-body air-supplied" suit* URL 16714 EXHIBIT A--16 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910*93q Section: (o) Medical surveillance (8) Objection: Mandatory removal of personnel from job. Grounds and/or Suggested Changes: The mandatory requirement for removal of personnel from potential vinyl chloride contact areas if upon medical rescreening one or more abnormal liver function tests persist, leaves the examining physician no room for judgement. Furthermore, removal of an employee to an area with '*no detectable level" of vinyl chloride, which in our opinion is unlikely to be found consistently in the vicinity of a vinyl chloride or polyvinyl chloride plant, would appear to leave no alternative but transfer or dismissal. We recommend that removal of personnel from a work area be the discretionary responsibility of the examining physician who will be in the best position to take into account all of the employee's symptoms and other medical background which can affect such a decision. s u 9 v i n EXHIBIT A--17 p. l of 1 Summary of Objections to Specific Sections of Proposed Standard 1910,93q Section: (n) Polymer handling operations Objection: "Detectable level" terminology* Grounds and/or Suggested Changes: For reasons previously stated, a "permissible" level should replace a no detectable level. Processing of polymer should be outside the scope of this Proposed Standard, Limiting of residual vinyl Chloride - e.g,, to 0,1% - in polyvinyl chloride would add further assurance of insignificant risk to process ing workplaces. URL 16716 EXHIBIT A-18 p. 1 of X Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section: (q) Reports Objection: Definition of "incidents"* Grounds and/or Suggested Changes: An "incident" must be better quantified to avoid overly burdensome and voluminous report requirements covering each incident involving tbe release of a small amount of vinyl chloride greater than some allowable permissible amount Incident reporting should be confined to those cases where~ in a massive or extraordinary amount of vinyl chloride is released into the workplace environment* URL16717 TEXT B p. 1, of 1 B. Technological Nonfeasibility Regulations involving protection of workers and their health must recognize the fact that absolute safety in any work situation is impossible* From a technical point of view steps can be taken to reduce risk to a minimum. At our FVC production facility it is not feasible to reduce airborne concentrations of vinyl chloride to zero. The attached report from our consulting engineers. Bowshot, Cooper and 0,Donnell supports this contention. (See EXHIBIT B) It is feasible to reduce exposure to vinyl chloride to a low level but not to a non-detectable level. At our plant we have initiated engineering changes and improved work practices to minimize worker exposure to vinyl chloride. A major change being planned involves automatic* vessel cleaning which requires an investment, in our relatively small operation, of over $1 million. Improved ventilation in general will also improve the working atmosphere. URL 16718 ^ * 19571 ROSELAND AVC. ^.Cleveland, Ohio 4*m7 Phone 692*0460 Bou>shot, Cooper & O'Donnell t {ENGINEERS June 14, 197A EXHIBIT B p 1 ol 2 M. U. COOPER J. r. O'OONNEUL N. K. FIELD N. C. SCHAEFFER 16570 16732 24376 23065 URL 16719 Uniroyal, Inc. P.0* Box 460 Painesville, Ohio 44077 Attention: Hr. W. M. Iliff Plant Engineer Subject: To reduce the concentration of Vinyl Chloride Monomer in the working areas of your Painesville Plant to a level of one part per million (1PPM) Dear Sir: Our study has indicated that from an engineering standpoint, reducing the concentration to this level is impractical to the point of being impossible. In reaching this conclusion we gave careful consideration to the following factors. 1. The "state of the art" at the present time does not permit the measurement of 1PPM of VCM in your area. All of the methods used for detecting VCM to some extent either respond to otheT hydrocarbons or are reduced in sensitivity by their presence. The use of alcohols and acetates etc. around and in the Uniroyal Plant plus marsh gas and automobile contaminants serve to produce > a variable "background" that would make calibration of any continuously monitoring instrument almost impossible to a level of one part in a million of VCM only. During our investigation of this problem we have examined most of the instruments used to measure the quantity of VCM present. All these instruments have had a poor history for serviceability. It is unlikely jhat immediate improvements will be made to increase their reliability ^beyond what is now being experienced. 19571 Roseland Ave. clevelaho. omo *4ii7 ' Phone 692-0460 Uniroyal, Inc. Bowshot* '_ Cooper c? O Donnell ENGINEERS June 14, 1974 EXHIBIT B p. 2 of 2 M. L. COOLER J. r. O'DONNELL ft, K. FIELO ft. E. SCHAEFFER 16570 16732 Z4376 23065 Page #2 2* Due to the batch process of making PVC, some VCM must be lost during cleaning and recharging of the vessels. 3. The polymerization or conversion of the monomer is less than 100% so that even with current stripping technology some of the monomer is included in the final product. Some monomer will be discharged from resin drying systems as well as in the finished product. 4* VCM must be stored, transported, and pumped at a pressure greater than atmospheric. The most assiduous maintenace program will not prevent some leaks. 5 Vinyl Chloride Monomer is a volatile explosive gas at normal ambient conditions and relatively low concentrations. The only safe method to eliminate the explosive danger after it has been exposed to aiT is dilution by ventilation. 6. The amount of ventilation required to approach 1PPM would result in air speeds through the buildings that would cause excessive noise, unsafe working conditions, and unacceptable structural changes to the walls for explosion release. The heat required to temper this volume of air would be an impractical waste of energy. 7. It is our opinion that the most practical way to significantly reduce VCM levels in a PVC resin plant is through the application of known engineering principles in the design of an entirely new facility. To bring a plant built within the last ten years to such a standard appears to be impractical. URL 16720 Very truly yours, BOWSHOT, COOPER & 0*DONNELL ENGINEERS 0,___, % JaWes F. O'Donnell Partner & Chief Engineer Howard L. Cooper Partner TEXT C p 1 of 2 C. PVC Processing and Fabrication We do not believe that the proposed Standard should be written to cover PVC processing workplaces* There is no evidence of medical hazard in these operations. Although it is possible to detect some VCM in the processing workplaces it is unusual to find any sub stantial concentrations. Proper workplace ventilation and emphasis on reducing residual VCM levels in PVC Should insure the absence of risk. Data on monitoring of processing workplaces within Uniroyal may be found in EXHIBIT C. URL 16721 IU.RUBBER n-ec^r' received JON 3 1974 EXHIBIT C p. 1 of 8 UNI ROYAL, Inc. Mishawaka (Uut<on) V. 0. Harris Oxford Attached you will find the initial results of our vinyl chloride sampling and analysis. The complete test method and chromatagraphic results are included. Ve will continue the program as we set it up dur7ng your recent visit. L. J. Grecco ' Manager, Technical Services cc: Factory Manager - Mishawaka URL 16722 INTERCOMPANY CORRESPONDENCE r-Ut l.*T tLS. RUBBER exhibit c p. 2 of 8 UNIROYAL, Inc. Mishawaka (Ueatnn) Hay 31. 197^ V. D. Harris Oxford Subject: The Determination of Vinyl Chloride-Monomer in Air A method has been developed by the Mishawaka Analytical Laboratory for the determination of VCM in air. Current tests are being done throughout the plant to determine VCM levels. This report will give the analytical method and the valves obtained to date: ]. Apparatus 1. Hewlett * Packard 7620 Gas Chromatograph with flame ionization detector and recorder. 2. TWo stainless steel chromatographic columns: i. a 10' X 1/8" 10% Silicone SE-30 on diatoport S. b. 20' X 1/8" 10% FFAP on Chromosorb WAN DMCS. 3. 100 microliter gas tight syringe (Hamilton Co.). 4. Air sampling pump. Willson Products Division, ESB incorporated. 5. Flcwator tube. Laboratory Equipment Corp. 6. Charcoal tubes 5" X 8 mm packed with Darco 12 X 20 charcoal, washed and dried. 7. 5 ml pipet. 8. 10 ml glass stoppered volumetric flask. 9. 10 microliter syringe (Hamilton Co.). 10. Lecture bottle - pure VC or gas (Matheson). 11. CS^ Spectro grade (Fisher). URL 16723 INTERCOMPANY CORRESPONDENCE Octermination of Vinyl Chloride Monomer in Air EXHIBIT C p. 3 of 8 Page 2 II. Procedure for Sampling The sampling tubes were prepared in the laboratory as follows: Oarko 12 X 20 mesh charcoal was placed on a 30 mesh screen and washed thoroughly with tap water to remove impurities and fines. The charcoal was dried in an oven at 370F for two hours. The glass tube 5'* X 8 mm 0.0. was crimped slightly toward one end and packed with one inch and two inches of charcoal respectively, separated by a fiberglass plug and fiber glass plugs on each end. The tube ends were covered with polyethylene caplugs. Each tube was calibrated individually with' the Willson pump and flowator tube. The air volume sampled was 10 liters in every test. III. Description The 2 inch sample section of the charcoal tube was desorbed with 5 ml of CS . The blank section was disorbed with one mil CS2* Spectral grade CS2 was used in each case. URL 16724 IV* Inlection The solvent flush injection technique was used to inject 5 microliters of sample into the G.C. The chromatographic parameters were as follows: Range I02 Attenuation 16 Injection Port 200 C Detector 210 C Oven 100 C isothermal Hydrogen Flow Tank pressure 10 psi Air Flow Nitrogen Flow Tank pressure 33 psi Tank pressure 70 psi flow 50 mil/min Double injections of the sample was made on each column. Only one injection was made on the plank to show that it was VCM free. If VCH was found in the blank, its total was added to the sample total. V. Preparation of a Standard A standard was prepared from the lecture bottle by removal of gas from an attached rubber tube which was purged of all air. This gas was injected dl rectly onto a charcoal tube while drawing air with the sampling pump. The charcoal was desorbed with CS2. A description factor is not necessary as both the sample to standard are desorbed by the same method. iinumfrr'iftw"~mr*ixun. % The Determination of Vinyl Chloride Monomer in Air EXHIBIT C p* 4 of 8 Page 3 V. Preparation of a Standard (Cont'd.) Example: 100 micro!iters of VCM absorbed on charcoal and then desorbed with 5 mil CS^. Injected volume is 5 microliters. microliters X 100 * Oi/ul VCM injected 5 mil i This standard is called 100 ppm and relates to 1 mil of air at 100 ppm concentration. The sample peak heights are related to this standard by direct ratio. Analvtical 6. A, Shaw Deot. 492 D. K. Moore <0 SAMPLE DESIGNATION #18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 URL 16726 MISHAWAKA PLANT VINYL CHLORIDE SAMPLING DATA TABLE DATE TAKEN 5/23/74 5/23/74 5/23/74 5/23/74 5/23 / 74 . 5/23/74 5/24/74 5/24/74 5/24/74 5/24/74 5/24/74 5/24/74 5/24/74 5/28/74 5/28/74 5/28/74 5/28/74 /5 30/74 5/28/74 /5 30/74 5/30/74 LOCATION CF-6 Banbury KoKneader - Exit KoKneader - Blender CF-8 Banbury CF-8 Calander CF-6 Calander Hopper Car Under Silo (Inside) KoKneader - Mix Area Ensolite Banbury #2 Sea Id Bin Bldg. 120 Ensolite Banbury #4 KoKneader - Mix Area CF-6 Banbury CF-8 Banbury KoKneader - Blender CF-8 Calander Hopper Car CF-6 Calander Under Silo (Inside) Bag Storage Bldg. 120 VINYL RESIN IN USE VR-22 . 24 VR-23 VR-23 VR-22 & 24 VR-22 VR-22 VR-22 VR-22 VR-22 . VR-23 VR-24 VR-23 VR-24 VR-22 6 24 VR-22 VR-23 VR-22 VR-22 VR-22 VR-22 VR-24 P.P.M. V.C.M. 0.0 0.0 38.0 1.4 2.2 1.5 0.5 12.5 0.2 0.0 1.3 0.0 0.0 2.3 1.4 23.3 1.5 2.6 0.3 25.8 13.0 Notes; 1. Sampling - 0.5 liters/minute for 20 minutes using a WilIson-Casel1m Pump with Hishawaka fabricated 5 Inch charcoal tubes. 2. CF - Designated Coated Fabrics 3. All samples were taken with pump and sample tubes attached to operator In breathing zone area except samples #25 end 37, which were static samples. RECEIVED JUN 13 1974 EXHIBIT C p 6 or 8 UNIROYAL. Inc. Mishawaka * JUN 17 1974 rw*iDM. Df.V. Dr* W, D. Harris Oxford Attached you will find results of our vinyl chloride sampling and analyses for the: 1. Chicago Plant (initial) 2* Mishawaka Plant (supplemental) The test procedure is outlined in Mr* L. J. Grecco's May 31, 1974 report to you. D. K. Moore Manager, Analytical Services URL 16727 cc: J. R* Sellers INTERCOMPANY CORRESPONDENCE Sample Designation #43 #44 #45 #46 #47 #48 #49 M- MISHAWAKA PLANT VINYL CHLORIDE SAMPLING DATA TABLE Data Taken 6/7/74 6/7/74 6/7/74 6/7/74 6/10/74 6/11/74 6/11/74 Location KoKneader * Mix Area Seald Bln Bldg. 120 CF-6 Banbury CF-6 Calander Hobart Mixer CF-8 Banbury CF-8 Calander Vinyl Resin In Use VR-23 VR-24 VR-22 VR-22 VR-24 VR-24 VR-24 'k PP.M* V.C.M. 2.40,// 4.00 4.50 1.00 0.80 3.00 0.60 NOTES: 1. Sampling - 0*5 liters/minute for 20 minutes using a Wlllson-Casella Pump with Mishawaka fabricated 5 inch charcoal tubes* 2. All samples attached to operator In breathing zone area. 3. A third week sampling of the major manufacturing areas (except #47). ' 4. This data table is a supplement to the 5/31/74 report to Or. W. D. Harris from L. J. Graeco (G. A. Shaw & 0. K. Moore). * of 6 T le Designation #39 #41 #42 CHICAGO PLANT VINYL CHLORIDE SAMPLING DATA TABLE Date Taken 6/4/74 6/4/74 6/4/74 6/4/74 Location Static-Storage Banbury - On Operator Static - Storage Sheeter Mill - On Operator Vinyl Resin In Use VR-24 VR-23 & VR-24 VR-23 VR-23 A VR-24 P.P.M V.C.M 5.96 0.35 1.64 0.35 NOTES: 1* Sampling and testing - performed by G. A. Shaw (Mishawaka) per Mishawaka sampling 6 testing techniques* 2, This Is a first sampling and testing of this plant. 6219 nan 5H to CO H H O HO <0 TEXT C p. 2 of 2 Although we reject the concept of "zero exposure *' to vinyl chloride, we recognize - and accept - our re sponsibility to protect the health of our workers. We believe that low level exposure to vinyl chloride represents a minimal risk situation. We recommend that a finite "permitted level" be substituted in the Permanent Standard in place of the "no detectable" requirement. In our FVC manufacturing operation we feel that we can reduce airborne levels of vinyl chloride to under 50 ppm as a ceiling limitation. For practical purposes we strongly endorse the concept of a TWA value. In our opinion the TWA number could ultimately be set at 25 ppm and the ceiling at 40 ppm if it is felt that sufficient evidence exists to warrant reduction from 50 ppm called for in the Temporary Standard. It should be recognized that due to individual plant design and operation, compliance dates should be on a plant to plant basis. We urge that OSHA personnel - with outside engineering consultants if necessary - establish a proper and achievable timetable for regulatory com pliance at each plant location. Regarding the future, we do not believe that permissible vinyl chloride exposure levels should be set lower and lower unless there is more adequate medical justification. Proper epidemiological studies should be immediately initiated to evaluate the degree of risk at low levels of vinyl chloride exposure. URL 16730 - >v TEXT D p. 1 of 3 D. Economic Imoact Another major objection to the concept of "no detectable" restrictions on vinyl chloride involves the economic impact which would result from the closing of production plants due to the technological infeasibility of meeting such a Standard. The Department of Labor recognizes the validity of economic impact arguments in the prologue to carcinogen regulations issued as Part 1910*5 c-p (PR, Vol. 39, No. 20 - January 29, 1974)* They state ... "the intent of the standards is to reduce exposure of workers to any of the listed substances to the maximum extent practicable, consistent with continued use". The prologue also exempts or excludes certain opera tions or levels of alleged carcinogens on the basis that with out such exclusions or exemptions the Standards ... "would have the effect of closing down large segments of industry, such as steelmaking, wood preserving, roofing, aluminum reduction, and possibly even power plants". The polyvinyl chloride (PVC) industry is the single most important segment of the entire U.S. plastics industry. Annual output of base resin is close to 5 billion pounds per year. A recent survey by Peter Sherwood Associates (Chemical Marketing Reporter - 5-27--74) projects growth to 8.5 billion pounds in 1980. It should be recognized that the growth of PVC to this tremendous usage stemmed from the unique properties of this resin. Uses and fabricating techniques have for the most part been developed to handle PVC and are not easily adapted, or adapted at all, to other materials. One does not simply substitute rubber or another plastic without substantial changes in skills, equipment and capital costs. URL 16731 TEXT D .p. 2 of 3 A rough breakdown of application areas follows. Marketing Reporter - 5-20-74) {Chemical PVC Use Areas Pipe and Fitting Flooring Construction Wire and Cable Furniture Transpor ta tion Film and Sheet Textile, Paper and Adhesives Sound Records Export Miscellaneous : : i : s s 27% 10 6 9 6 5 4 5 3 *3 20 The total worth of the PVC industry in terms of jobs and dollars is difficult to measure exactly but it is known to be responsible for hundreds of thousands of jobs and many billions of dollars. Other presentations at this hearing will give additional data on the magnitude and importance of the PVC industry* To grasp the proliferation of impact starting with our Chemical Division PVC production facility, we have made a rough economic analysis based on predicted effects on Uniroyal as well as our customers. It has been noted that although we are a small producer of PVC (about 3% of the U.S. total) the impact of a shut down of our PVC plant would create severe economic effects* At our Painesville, Ohio PVC production plant we employ about 300 people with an annual payroll of about $4 million* The resin we produce is used by other Uniroyal divisions and outside customers giving employment to over 25,000 people and an annual payroll of over $200 million* URL 16732 TEXT D p. 3 of 3 Communities that would suffer from the loss of PVC - related jobs within the Uniroyal corporation are: Painesville, Ohio; Port Clinton, Ohio; Stoughton, Wisconsin; Philadelphia, Pennsylvania; Mishawaka, Indiana; Chicago, Illinois; Farmville, Virginia, and Washington, Indiana, Industries that would be severely affected by curtailment of our PVC production operations include: coated fabrics, flooring, footwear, medical, automotive, shoes, hose, insulation, wire and cable. In EXHIBIT D we have illustrated some detailed effects that would results within the Uniroyal organization. URL 16733 ronaois* JUfl : 3 1974 :cm. cev< EXHIBIT D p, 1 of 4 uniroyal, inc. QKFORD D-2-2 (Location) June 12, 1974 R. J. Dowling NAUGATUCK CHEMICAL SUBJECT: PROPOSED VCM OSHA REGULATION #1910.939 The Plastic Products Division would be forced to shut down our Coated Fabrics and certain Royalite ABS-Thermoplastic Sheet operations if the proposed Government standard of "zero" or "no detectable level" of vinyl chloride exposure is made permanent. This would result in an immediate loss in Divisional sales of over $100 million/yr* At a minimum, 1,812 salary and wage jobs would be eliminated with an annual value of wages and salaries in excess of $18,580,000. (This value is exclusive of Fringe Benefits) The number of employees effected with monthly wage and salary loss ty plant is listed below: PLANT WAGE EMPLOYEES MONTHLY WAGE LOSS SALARIED EMPLOYEES MONTHLY SALARY LOSS SALES!* URL 16734 Chicago, 111, Stoughton, Wise. Port Clinton, Ohio Masland-Phila., Pa. Mishawaka, Ind. 150 240 250 350 360 $155,204 198,663 192,436 230,046 305,712 30 42 65 90 147 $ 35,268 42,116 62,906 91,702 139,240 4 12 73 The economic impact on the local communities of Mishawaka, Port Clinton, and Stoughton would be extremely severe since these plants are either the largest or next largest employer in their respective area. In addition, approximately 122 Coated Fabrics Distributors averaging 10 employees each would be effected as 26% of their business is derived from the sale of vinyl coated fabrics. t J cc: W. J. Mulvey charc^Morgan INTERCOMPANY CORRESPONDENCE r-a* rbwi JUN 7 1974 com. dev. EXHIBIT D p* 2 of 4 UNIROYAL, Inc. Consumer Products Oxford R-I-51_________ (Location) June 6, 1974 TO: R. J. Dowling Naugatuck Chemical Division FROM: F. C. Cesare SUBJECT: Proposed VCM OSHA Regulation #1910.93q Re: Consumer Products Co*_______ The Consumer Products Co* would include the Farmville, VA and Washington, Indiana plants* In Farmville the economic impact would be as follows if we could no longer operate under the non-detectable OSHA requirements, loss in Net Sales in excess of $6 million. URL 16735 Salary and wage jobs eliminated 216. Value of wages and salary in dollars $1,600,000. The loss of $2,600,000 in materials cost and overhead which includes purchases from local vendors and the community such as taxes, utilities, etc. At the Washington Indiana plant the loss in net sales would be over $4 million and the elimination of 100 salary and wage positions. The value of salary and wages is $870,000 and the materials and overhead dollars which would be lost to the community is estimated at $366,000. Since the Washington Indiana plant manufactures other products it is conceivable that a balanced plant could not exist profitably and that under these conditions the losses could be greater. In the event of total plant shut down the loss in net sales would amount to $12,000,000,the salary and wages lost would be approx imately $3,585,000- The materials and overhead dollars lost to the local community and vendors would be $1,335,000. The total number of positions eliminated assuming complete plant close down would be 416. INTERCOMPANY CORRESPONDENCE R. J. Dowling Naugatuck Chemical Div June 6, 1974 Page 2 EXHIBIT D p, 3 or 4 There are no substitutes for plastisol or slush cast footwear in Farmville, VA or for the clothing operation in Washington, Indiana. $ FCC/dh cc: D. Thomson P. G. Brown E C. VanBuskirk D. Dudrow F* C. Cesare URL 16736 urjinoYALi I. - 31 EXHIBIT D p. 4 of 4 UNIROYAL, INC. Route 2, Sox 32 RECEIVED Farmville, Virginia 23901 JUN 1 2 1974 T. June 1, 1974 D. I HUMSW Mr* John Stender Assistant Secretary of Labor U* S. Department of Labor Washington, D. C. 20210 Dear Mr. Stender: We have been following with some developing on the Poly Vinyl Chloride proposed rules for emission standards Regulation 1910.93Q* interest the information problem and have read the as contained in OSHA Our plant currently employs some 220 people with an annual payroll in the area of $1,600,000. In addition we are billed from the community for services some $600,000 annually. ;* $ , , .The material cost for manufacturing our products approximates 1 600 000 We are certainly receptive to practical regulations for the protection of personnel both in industry and at the consumer level and encourage such action. Any regulations set up must be manageable and realistic in order for us to protect the livelihood and health of everyone involved. Any impractical regulations resulting in cutbacks or shutdowns would certainly introduce undue hardship on people employed in our plant and have an adverse effect on the local community. Any efforts by your department to help insure practical regulatory procedures while also insuring proper health safeguards would be appreciated. URL 16737 ACY:sw Factory Manager Uniroyal, Incorporated Farmville, Virginia Uniroyal Vinyl Chloride and Polyvinyl Chloride Experience TEXT E . p 1 of 2 sem w We started making both VCM and PVC in Painesville, Ohio in 1947* In 1961 we discontinued VCM production and started pur chasing our VCM requirements from Monochera (a Joint company formed by Uniroyal and Borden)* At all times - up to the present - the acetylene process has been used for VCM product ion* Our PVC operations involve the manufacture of both suspension and dispersion resins* We also manufacture a PVC-nitrile rubber blend at our Painesville facility* Our total work force is about 300 people, 56 of whom have been employed continuously for over 25 years* No cases of either acroosteolysis or angiosarcoma have been found among any of our workers (See EXHIBIT E, p. l). NX OSH published data (EXHIBIT E, p. 9) shows 13 cases of deaths from angiosarcoma in the U*S. confirmed as related to vinyl chloride* These cases were confined to only 4 individual plants out of 36 producing locations, Further, it should be made clear that there hasn't been any significant increase in annual rate of angiosarcoma fatalities as shown by available yearly summary data: Year Angiosarcoma Deaths 1961 1962 1963 1964 1965 1966 1967 196B 1969 1970 1971 1972 1973 1 O O 1 O O O 3 1 1 1 O 2 2EXT E p. 2 of 2 Since more and more people have become directly involved in vinyl chloride operations over the past 30 years, if this chemical was a truly potent human carcinogen there should be an Indication of such a fact by a steady increase in angio sarcoma fatalities. As yet, these have not materialized. It is recognized that more vinyl chloride related deaths could come in the future but we believe it is scientifically reasonable that these occurrences will also relate to earlier extensive exposures to high levels. The relatively recent overall industry reductions in exposure coupled with future mandatory reductions should eventually reduce the hazard to a minimal risk situation. We do not believe that the available human medical evidence warrants reduction of worker exposure to **non-detectable levels". Experiments with animals may suggest levels of potential hazard but these levels are not exactly translatable to man. In fact, as prior testimony has strongly indicated, the methods used for projecting animal data and correlating with expectations of similar occurrences in humans are far from precise. Identified angiosarcoma cases in man to date appear to be directly related to high level, long term exposures. A review and update of medical and toxicological considerations by our Corporate Medical Director, Dr. J. D. Forbes and by our Corporate Toxicologist, Dr. W. D. Harris, may be found in EXHIBIT E, pp 2-12. URL 16739 v 1: EXHIBIT p. 1 of 12 UNIROYAL, Inc. OXFORD (Location) June 14, 1974 TO: V. D. Harris FROM: J. D. Forbes, M.D. SUBJECT: MEDICAL RESULTS FROM PAINESVILLE Ever since the description of acroosteolysis, we have been conducting an examination program for those in poly cleaning, ye can report that we have had no cases of acroosteolysis. We are continuing on with our annual examinations for all active poly cleaners with the evaluation consisting of a special AOL history, physical examination and hand x-rays. Since the plant has an annual or biannual (depending upon age of the employee) exami nation program, all individuals who have worked in poly cleaning in the past are covered in our medical surveillance. In regard to the recent revelations about angiosarcoma, we have found no cases in Painesville to date. We have followed the NIOSH medical surveillance recommendations of screening the entire plant with a brief medical history, limited physical examination, and five biochemical tests of liver function. (These are total bilirubin, alkaline phosphatase, SGOT, SGPT, and GGTP.) To date, 410 people have had initial biochemical tests complete with the result that 46 (11.2%) showed abnormalities in one or more of these five tests. Rescreening results have returned on less than half of these 46 with the result that all of them continue to show a persistance of one or more abnormalities. Thus it would appear with our testing still under way that those who will deserve an extended and individualized medical evaluation might be in the vicinity of the same 11.2%. At Monochem, our vinyl chloride monomer plant where our exposures have been significantly less, 44 people have had initial biochemical screening with the result that 7 individuals (15.9%) showed one or more abnormalities. Rescreening is presently in progress. JDF/mab O biJU Itin INTERCOMPANY CORRESPONDENCE statement re "detectable levels" EXHIBIT E p. 2 of 12 The concept of "detectable levels" Is unrealistic and meaningless. Hardware is now available to detect a few parts per billion of VC and this can undoubtedly be extended. If this wording persists those who favor the zero concept will insist that the most sensitive tests be used resulting in unnecessary expense and waste of scarce technical manpower. Furthermore, there is nothing in the toxicology data to support the need for such low levels. TOXICOLOGICAL DATA URL 16741 He are indebted to Prof. Cesare Maltoni for his excellent animal studies which throw careful light on the toxicity of vinyl chloride. The earlier work of Viola showed that while animals can live in tremendous concentrations of vinyl chloride for long periods with no apparent effect, under these conditions it caused cancer. Maltoni extended and greatly refined these studies. Bis data are presented in English translation in Tables II and HI which follow. The complete tables from which these data were taken are from a paper by Cesare Maltoni and Guiseppe Lefemine, Estratto dal fasc, .3, Serie VIII, Vol. LVI, and Marzo 1974 are given untranslated in the pages which follow our tables, Experiment BTl involved exposure of animals at the various concentrations for 52 weeks and observation until death. At the time the paper was presented this was 130 weeks and a few animals were still alive. Experiment BT3 is Identical except that the animals were exposed for only 17 weeks and at the time of writing observation had continued for a total of 59 weeks. To get a comparison he shows records for BTl at 59 weeks. TABLE II Experimental BTl: Experimental Results at 130 Weeks EXHIBIT E p. 3 Of 12 (Sroup and Treatment Animals (Rats) Sprague-Davley Animals With Timers Total Living Carcinoma of the Zymbal Nephro Gland blastomas Angiosarcoma Other Liver Locations Other Types and/or locations Total 1 Vinyl Acetate 96 2500 pint mm m < II VC 10,000 ppm 69 - 16 4 7 III VC 6,000 99 IV VC 2,500 n 72 74 - 7 4 0 13 2 2 6 14 3 V VC 500 It 67 - 3 4 72 6 25 1 24 1 24 1 16 VI VC 250 ft 67 1 -- 6 42 VII VC 50 fl 64 3 - - -- VIII Control 68 1 - - - - 2 12 -- -- TAL 577 5 26 24 45 9 11 101 URL 1674 TABLE III Experimental BT3: Experimental Results at 59 Weeks Group and Treatment Animals (Rats) Sprague-Dawley Total Living I VC 10,000 ppm 11 VC 6,000 ppm III VC 2,500 ppm *v VC 500 ppm V VC 250 ppm VI VC 50 ppm VII Control 60 60 60 60 60 60 190 36 48 54 56 44 50 183 Animals With Tumors of the Zymbal Gland Nephro biastomas Anelosarcoma Other Liver Locations Other Types and/or locations Total 3 1 -- -- - -- - -- - - - - -- * -3 -1 ---- - -- --- *- TOTAL 550 471 4 4 * 4 6 Lincei - Rrad, Sc. fis. mat. e nat. - VoJ. LVI -- marxo 1974 Nellc Tahcllc II-V1 vengono esposti i dati prclirninari relativi agli csperi- tnenti BT 1, BT 3, BT 6, BT 5, BT 4. Per quanto conccmc gli altri esperimenti dofabiamo attenderc arscora per averc risultati. Da quanto presenxato nclle Tabelle e dallo studio istoiogico emergono i seguenti punti: j) j] CV e onco^cno ncllc condizioni sperimentali da noi saggiate: esso provoea carcinomi dcl'e ghiandole di Zvmbal (fig. 1), nefroblastomi (fig. 2) angiosarcomi cpatici (figg. 3, 4) e di altri tessuti ed organi (figg. 5, 6) nel ratio, e adcnomi-adcnocarcinomi polmonari, carcinomi mammarii e angiosar" comi cpatici nel topo; *. EXHIBIT E p. 4 of 12 -- Ctl*i * **ATTA! Tabella II Esperirrunto BTi: Risultati sperimentali a Jjo settimone Gsuppi % TEATTAME.VTI AxratAU (RATTl SPAAGUE- DAWLEY) A K t 21 A L I COX Tl'UOtl i f Carcino mi delle Nefro ghiandole blastomi di Zvmbal <A) <B) Angiosarcomi Fegato vC) Altre localizzazioni Altri tipi e/o loealizzaiioni Totale (0) N. N. N. N. N. U AV 2.50 PP<n 96 ____ _ -- ---- -- H) CV 10.000 ppm 69 -- 16 4 7 -- (H) 25 ni) CV 6.000 ppm 73 -- 7 4 *3 3 (t 3 (I) 34 TV) CV 2.500 ppm 74 1 2 6 14 3 (E) 1 (L) 24- V) CV 500 ppm 67 1 i 3 4 7 a (E) 1 (M) 16 VI) CV 250 ppm 67 ! . --* 6 4 a (G) a (N) xa VII) CV 50 ppm 64 3 -- -- -- -- -- -- VIII) Nosun trattamento . . . 1 68 l 1 -- -- *- ---- 1 sTotajle . . . 577 38 34 45 9 IX 101 1 A) Metastasi al polmorr. B) Metastasi al fegato e('o al polmone e alia milza. C) Metastasi al polmonc. D) J angiosarcoma in angioma tibrosantr sortocutaneo; 1 angiosarcoma ssincantc auricolare. El 2 angiosarcomi iniraddonnnali (1 vicmo alia iniiza. 1 vicino all'ovaio";; t angiosarcoma ossificantc latcrocervicale. 1`; 1 angiosarcoma polmonarc; 1 angiosarcoma riell'utero. C) 1 angiosar coma intradUominalf ;vicim> alk.i milza'; 1 angiosarcoma ossificante intrntoracico. H) 2 adeuomi dclle ghiandole di Zyxnbal; 1 neurilemmoma del padigliont- auricoiarc; 3 carcinomi mammarii; I cistoadmocarcinonia dcH'oeaio. i) 1 carcinoma sob;ceo della cure. Li t adenoma delle gbiandole di Zymbal. M) 1 epaioma a minima devmzione. X} 1 adenoma dclle ghinndole di Zytnbal; 1 car cinoma dclle ghiandole salivan. Oj Lbvcrsi animaJj con due o piu tumori. I 1 C 33 c--ni -5* CO 1) CV10 ID CV6t III) CVS; IV) CVj: V) CVa5 VI) VII) N'essi ment Tot; 0)1 59 setting G THAT I) C\' < Ol O 1 > ) 1 -- jtale 0) ; -- *5 U 16 11 01 >i at iuri* onu war* <omi lArii; dole car* EXHIBIT E p. 5 pf 12 -*5' ' C. MALTOXI e C. Lefemivk. Lc ^eUsinhia /tei st/ggi speritnentali, tee. - >' 7 Tabella III EsPeritncnto BT5: Risuhati sperimcntali a 59 xettimane <1J Aximali (rattiShragve- Dawlev) AKIMAtl CON TUMORI i GfcUPM z TRATTAMLXTl Carcino* mi dcllc Nefro- Total? Soprav- gliiotidole blastomi vissuti di Zymbal Angiosarcomi Fegato Ahrc localiz* zazioni Attri i tipi e/o localiz* Totale zazioni <i) N. N. N. X. N. N. I) CV 10.000 ppm 60 36 3 00 - w -- () _ -(4) 3 05) II) CV 6.000 ppm 60 48 1 (3) -- (2) -- (3) -- (1) -- * (9) * III) CV 2.500 ppm 60 54 -(2) -- (0 - (1) -- -<*> -(5) | IV) CV 500 ppm 60 5* -- ti) -- -- <D -- -- -- (2) V) CV 250 ppm 60 44 -- -- -- (1) -- -- -- (1) VI) CV 50 ppm 60 50 -- -- -- -- ---- VII) Kessun tratta* mento .... 190 183 -m URL 16744 Totale . . . 550 471 4 <17? -- (5) -- (8) -- w - (5) 4(3^) (l) Tra parentesi viene indicato il mnnero di tumori mcontrati neiresperimento BTl, dopo 59 settimanc. (2) Alcuni animaii con due tumori. -- -- ~ -- Tabella IV Expcrimento BT6: Risuitati sperimcntali a 34 ssttimane Gruppi Z TRATTAMENTI Aximali (RATTI SPRAGUEUawley) Aximali con tumori \ Totale Sopravvissuti Carci nomi dcllc Netro* ghiandolc blasionu di Zymbal Argriosatcomt Fcgato Alt re localiz* zazioni Altri i tipi e/o localiz* Totale 2azioni N. N. X. X. N. N. I) CV 30.000 ppm 60 60 3 ---- '-- -- 4 EXHIBIT E p, 6 of 12 Total tumors are summarized for both BTl and BT3 in simplified form, (1) It is obvious that the critical concentration range in experiment BTl is between 250 and 50 ppm. Studies are underway at 100, 150 and 200 ppm. (2) Both time of exposure and concentration are important factors. Table 3 from the TabershawCooper report shows number of workers entering the work i force where VC was handled either in monomer or polymer plants. Mote the rapid growth of the industry in the 50's and 60*s. URL 16745 Host of the angiosarcoma have been found in workers who were vessel cleaners. There is general agreement in Europe and the U.S. that exposure in the early years of the industry in the vessel cleaning operations probably exceeded 1,000 pgm. We know that some men were overcome by VC indicating concentrations over 10,000 ppm. In the late 50*s and early 60's most manufacturers tightened the operation somewhat to reduce losses for economic reasons and also to try to conform to the 500 ppm TLV. However, explosion meters were used as monitors so the available data is not precise. The identification of acroosteolysis in this country in the late 60*s and of angiosarcoma in January 1974 has resulted in an order of magnitude reduction in exposure so that most plants are now well below a TWA of 50 ppm except for vessel cleaning where it is necessary for the present to wear supplied air respirators. Keeping the above in mind, it is interesting to dissect the data compiled by NI0SH. Year of First Exposure 1944 U.S MIOSH No. 05 Years In FVC 18 Years From First Exposure to Death 20 U.S 07 18 24 Ave 25 U.S 13 30 30 (alive) M 3? oa *Qo-* URL 16746 ,,--f... ...--,I--trT-rj ~C--6.'-KA> -L*?--& O_ -O: ' ! ! i: : ! ; i ; 1 : i . I . i : }: j. . i i. i : i --{ t--rr--!---i-- t-- T"~ O-- O-^ -0~ O-- p? x-j- 3 c-5Jo*.*- j'.'d \ ^i 1 !':: I 1 i. . i ;. J j- j j' i ] t.r I! 1.. t EXHIBIT E p. 8 Of 12 >* A p r il IS , 1974 1 1 * * * H 0 rt U *+ * ^ ^ f-- t-- o o o o o O' W> i' U ooo o o 4 1 1 i g O' v/i f' lj vft >0 iO troe re U ZJ re n rt re m (X X o * 3 w sz -4 w - si U O O o i-r ro - O' O' i' w 00 oi o to Co m g n=r M *Xo o (n Cn a N w* *o %1 <4 U H (41 I-* -> Co u Ul ui VO U< M * O' o a (a w r* O(tQft I O" ac : S .< ` ft , * O' *- o o 4* U1 O -- a* NSU^ t--* o o3 n o OTV \0 aro> 5 3 t-* ro <H* o O' H U r- r vO O CD H oo m W <0 r 0 vO .S3 3 h- :< 6c-*Jr !r-e co to rO+1- TOv3i u so O' -- O3 i rt (aft. nQ. CO O' Ur- Ur--l X* fO 3* W VI w o o oi *3o i-n X* t- <r in M ro IO pi X O *3 io (9i vO: wg rft <3 xi CO O' CD >sj ro to r in M sJ O' vT> c vO ri sr cr -wj o s; N in O ro UJ hsi U to o o 1 to u> *3o fior-et* (ft noj o a. *1 O u; O' o o 1 u o U * in Xs *-* v) co . c j X* 3 u r-- rg o M O tO *: n /* Year of First Exposure 1945 1946 1 - NIOSH No. U.S. u.s. 03 09 Sweden 02 U.S. 08 U.S. 11 6r.Br. 01 1948 1949 1950 1951 1952 1955 1957 1962 U.S, U.S. Norway U.S. Sweden U.S. U.S. W.Ger. 01 12 01 10 01 04 * 02 01 02 U.S. 06 Total 19 -4- . Years In PVC 28 17 23 15 23 20 16 15 21 17 19 15 13 14 11 12 Ave 18.2 EXHIBIT E p. 9 of Years From First Exposure to Death 28 29 Ave 28 27 15 23 Ave 22 27 Average to here 25 25 20 22 17 19 15 16 14 11 12 (alive) "" _Lr S 21.3 URL 18748 Two points appear likely. (1) The cause of death for some of the people who died front exposures in the early years has not been found. The records for those who died in the 50's are probably not readily found. i fM <H U) o HO HH 03 URL 16749 CONFIRMED CASES OF LIVER ANGIOSARCOMA AMONG PVC WORKERS COUNTRY CASE 0 BIRTH 1 DATE 1st PVC WORK DX ANGIO SARCOMA AGE AT DX i YRS 1st PVC TO DX TOT YRS PVC PATE OF DEATH United States 01 United States 02 United States 03 United States United States 05 United States 06 Uni ted States 07 United States 08 United States 09 United States 10 United States 11 United States 12 United States 13 W. Germany 01 W. Cerraany 02 Great; Britain 01 Norway 01 Sweden Sweden 01 02 00-00-22 00-00-34 00-00-15 00-00-24 ' 00-00-12 00-00-29 ` 05-03-22 05-06-20 00-00-31 08-16-13 05-27^09 * 31-.17-18 32-01-21 07-26-31 06-04-30 00-00-01 12-23-15 00-00-27 * 00-00-11 12-09-48 11-15-55 11-28-45 07-06-52 06-19-44 01-17-62 08-00-44 10-07-46 05-23-45 06-00-51. 10-J 4^46 09-13-49 08-19-44 ` 10-14-57 * ` 10-01-57 00-00-46 03-00-50 00-00-51 00-00-45 03-00-71 05-00-70 12-00-73 08-00-67 .04-00-64 02-00-74 00-00-68 08-00-61 03-01-74 05-00-68 Q3-QO-7G 05-00-69 05-00-74 ' 00-00-71 00-00-69 12-00-72 12-20-71 00-00-70 00-00-72 49 22 36 14 58 28 43 . 15 52 20 45 12 45 24 41 15 43 29 55 17 . 61 . 23 50 20 53 30 40 14 . 39 * 11 71 26 56 22 43 19 61 27 16 n' 28 15 18 12 18 15 17 17 23 ` 15 30 ` 14 11 20 21 18 25* 03-03-73 09-28-71 12-10-73 01-07-68 04-09-64 ALIVF 03-23-68 08-29-61 ALIVE 05-10-68 03-16-.7CL 05-02-69 ALii'E 12-14-71 01-25-59 12-00-72 01-04-72 00-00-70 00-00-72 r Note: 00' indicates unknown dace Note: In Column titled YRS 1ST FVC TO DX the Mean 20, the Median - 20 and the Modes 14, 15,*20, 22. Nates In Column titled TOT YRS FVC the Mean 18, the Median \J and the Modes 15 and 18. 5- EXHIBIT E p. 11 of 12 (2) Additional cases of angiosarcoma are likely to be found for several years from the people exposed In the early fifties no mater what steps are taken today. This is almost certain to be interpreted by the untrained as Indicating that controls are not tight enough. The paragraphs which follow are intended to show that the steps already taken should eliminate the problem of cancer due to VC once the already exposed population is removed from consideration. Looking back at the compilation of cases by year of first exposure note that the longest period of exposure is 30 years and this worker is still alive. At the Other extreme we find a West German worker who died after only 11 years exposure. Assuming 1000 ppm TWA exposure all fall between 11,000 and 30,000 ppm years. (From the various reports reaching this country It is likely that exposure in the German plant was particularly high). If we apply a liberal safety factor of 10 (remembering that we are using human data so there is no need for the 100 fold safety factor relied on by FDA to convert animal safe levels to general human exposure), we arrive at a figure of about 1000 ppm years. Thus a worker could work for 25 years at 40 ppm, 40 years at 25 ppm, 100 years at 10 ppm, etc. r Our sampling confirms what others are finding that monomer plants generally operate with tio more than a very few ppm exposures. Fabricating, plants for the most part operate at 0-5 ppm with a few "hot spots" in storage areaswhere the breathing sone level can reach as high as 25-50 ppm but typically noone works steadily in these locations. Thus monitoring in these plants can be greatly restricted, limiting it to those areas shown by preliminary study to have the highest levels. PVC planes should be monitored periodically in all areas which are frequently URL 16750 -6 EXHIBIT B p 12 of 12 *5 above TWA of some level such a^ppm. Sequential samplers should monitor carefully chosen spots as an ongoing check with alarms set when excursions indicate a leak. VDH/mab 6/17/74 V. D. Harris, Fh. D URL 16751 * CONCLUSION p. 1 of 2 1 think that the testimony and comments presented at this hearing should have made it clear to all of us who are concerned with the health of people and of the economy that the precipitate action proposed in the Permanent Standard would not be in any one's best interest. I believe Dr. Hammond, Vice President of the American Cancer Society, made a very rational statement when he said, as quoted in the news media, "There's no such thing as zero risk; I want to get the risk down as low as feasible, so low that I wouldn't hesitate myself to take that employment. But 1 don't want to make it so low that I couldn't earn a living....* We would like to go on record in favor of a practical and reason able set of controls* We feel in good conscience that a tahiTir weighted average of 50 ppm of vinyl chloride in both vinyl chloride monomer plants and polyvinyl chloride plants would be proper protection, supported by the data now available. We believe that there should be no restriction on polyvinyl chloride processing and fabricating plants so long as the residual vinyl chloride content of the resins used is not over 0.1%. (CONTINUED) URL 16752