Document rBJ8ozKLMG8vk7wM4VLGBgMmr

- CTp v u) 0 SUMMARY OF TESTIMONY BY UNIROYAL, INC. IN OBJECTION TO THE PROPOSED roRMANENT STANDARD 1910.93q RELATING TO VINYL CHLORIDE EXPOSURE DOCKET OSH-36 URL 18439 Jun 21, 1974 i 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 am Martin J. Kleinfeld, Commercial Planning Director of the Chemical Division of Uniroyal, Inc. I am a chemist and for 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 I have been successively Marketing Manager and Research and Develop ment 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~, Rldhafd^ Sfetiwc of Arthur, Dry & Kalish, our legal firm. -- Uniroyal 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) URL 18440 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/PVC 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. e 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 level" restriction. This, has been detailed in our EXHIBITS A-l, A-2, A-3, A-7, A-9 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-n) (CONTINUED) 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 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. (See EXHIBIT A-16) EXHIBIT A-I p. 1 of 2 Summary of Objections to Specific Sections of Proposed Standard 191093q URL 18443 Section: (a) Scope and application (1) and (2) Objection: 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-dectable" re striction is technologically infeasible in vinyl chloride l 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 *s to cost and utilisation of manpower. Ample precedent regarding exclusion of products containing trace amounts e.g., 0*1% - of potentially hazardous materials may be found in Fart 1910.93c-p, the recently promulgated standards on 14 alleged carcinogens. EXHIBIT A-l p. 2 of 2 We 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. t r r MRL 1o444 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 1844 EXHIBIT A-3 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q IJRL 1844b 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 PVC industry creates a difficult problem for a variety of reasons. Certain monomer plants - because of the nature of r 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. Our 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 1910.93q 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 18447 EXHIBIT A-S p* 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910,93a Section: (b) (Definitions) (lO) Objection: "Semifinished product" Grounds and/or Suggested Changes: Definition needs expansion to include "diced or pelletised stock" made from polyvinyl chloride. URL 18448 EXHIBIT A-6 p. I 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 would 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. f * 6 t*8 iia n EXHIBIT A-7 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Sections (d) Regulated areas (1) (ii) Objections Definition of regulated area involving polyvinyl chloride operations. Grounds and/or Suggested Changess Reasons have previously been stated regarding the need to change "detectable level" to "permissible level". Regarding application to polyvinyl chloride, the regulated areas should be restricted to those operations or activi ties where vinyl chloride levels in the air may exceed the established permissible level* URL 18450 EXHIBIT A-8 5j p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910,93q Section: (d) (Regulated areas) (3) Objection: Maintenance of "daily roster". Grounds and/or Suggested Changes: 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. : t URL 18451 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 tone confusion regarding appro priate monitoring methods as related to personal monitor ing versus area monitoring or a combination of both techniques. URL 184' 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 Changes: This entire section addresses itself to the need for immediate use of engineering controls and methods to reduce airborne concentrations of vinyl chloride to zero. Reasons have been previously stated indicating the infeasibility of the zero 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. r < URL 13453 EXHIBIT A-ll p. 1 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 18454 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 j 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 recognised that the volatile nature of vinyl chloride pre cludes the possibility of any significant residual life. EXHIBIT A-13 p* 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section: (j) Emergency situations Objection: Definition, Shower requirement. Grounds and/or Suggested Changes: "Emergency" is defined (Webster) as: "an unforeseen combination of circumstances or the resulting state that calls for immediate action." 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 18456 EXHIBIT A-14 p. 1 oil Summary of Objections to Specific Sections of Proposed Standard 1910.93q URL 18457 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. f * EXHIBIT A--15 pa 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, [ l The "whole-body" suit is objected to for reasons previously stated. It must be emphasised that this Proposed Standard is for the purpose of reducing an alleged carcinogenic medical risk. We are unaware of any indictment of vinyl chloride involving such a risk by skin absorption of airborne vinyl chloride, c XI ^ ^ ^ 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 ,(whole-body air-supplied" suit. 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. URL 18459 EXHIBIT A-17 p. 1 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 mould add further assurance of insignificant risk to process ing workplaces. [ l URL 18460 EXHIBIT A-18 p. 1 Of 1 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 the release of a small amount j- of vinyl chloride greater than some allowable permissible ; amount Incident reporting should be confined to those cases wherein a massive or extraordinary amount of vinyl chloride is released into the workplace environment. 5 2 a* TEXT B p. 1. of 1 B. Technological Nonfeasibilitv 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 PVC 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 O'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. : ?c URL 1846i 19571 Roselano Awe. Clevelaho, Ohio mii? Phone 692-0460 Boutthot, Cooper & O'Donnell ENGINEERS June 14, 1974 EXHIBIT B p. 1 O* 2 h. u. cooper J. F. O'DONNELL R. K. FIELD R. E. SCHAEFFER 1*570 11712 2437* 230*5 URL 184153 Uniroyal, Inc. P.0. Box 460 Painesvllle, Ohio 44077 Attention: Mr. W. M. Iliff Plant Engineer Subject: To reduce the concentration of Vinyl Chloride Monomer in the working areas of your Painesvllle 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 other 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 that immediate Improvements will be made to increase their reliability beyond what is now being experienced.  *. , J 19571 Pose land Ave. Cleveland. Ohio **m Phone 692-0460 Uniroyal, Inc. Bowshot, Cooper & 0*Donnell ENGINEERS June 14, 1974 EXHIBIT B p. 2 of 2 H. L. COOPER J. O'OONNELL R. K. FlELO R. C. SCHAEFFER 11970 10732 24370 23009 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 malntenace 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 air Is dilution by ventilation. ; t 6. The amount of ventilation required to approach 1FFM 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 18464 Very truly yours, BOWSHOT, COOPER & O'DONNELL ENGINEERS James F. O'Donnell Partner & Chief Engineer i Howard L. Cooper Partner TEXT C p. 1 of 2 C PVC Processing and Fabrication W 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* ?t URL 1846' <w1 Ilf MV. 1.I7 IU.RUBIER RECEIVED JUN 3 1974 m i7 1974 EXHIBIT C p, 1 of 8 UNIROYAL, Inc. Ml shawaka (Location) W. 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. We will continue the program as we set it up during your recent visit. Manager, Technical Services ?t cc: Factory Manager - Mishawaka URL 13466 INTERCOMPANY CORRESPONDENCE " r<*a n<v. * U4.BU8SIR exhibit c P* 2 of 8 UNIROYAL, Inc. Mishawaka (taction) Hay 31, 197** W. D. Harris Oxford Subject; The Determination of Vinyl Chloride Monomer in Air i m i ia r( 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: 1, Apoaratus 1. Hewlett - Packard 7620 Gas Chromatograph with flame ionization detector and recorder. 2. TWo stainless steel chromatographic columns: f 9 * 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 Oivislon, ESB Incorporated. 5. Flowator tube. Laboratory Equipment Corp. 6. Charcoal tubes 5" X 8 mm packed with Darco 12 X 20 charcoal, washed and dried. 7.* 5 ml plpet. 8. 10 ml glass stoppered volumetric flask. 9* 10 mlcroliter syringe (Hamilton Co.). 10. Lecture bottle - pure VC or gas (Matheson). 11. C$2 - Spectro grade (Fisher). INTERCOMPANY CORRESPONDENCE Determination of Vinyl Chloride Monomer in Air EXHIBIT C p. 3 of Page 2 11. Procedure for Sampling The sampling tubes were prepared in the laboratory as follows: Darko 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 O.D. 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 ind?vfdua1 Iy witlr the Wi11 son pump and flowator tube. The air volume sampled was 10 liters in every test. III. Oescription 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 wis used in each case. URL 19468 IV, In ject ton 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 Detector 200 C 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 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 VCM 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 directly 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. The Determination of Vinyl Chloride Monomer in Air EXHIBIT C Pi 4 of 8 Page 3 V. Preparation of a Standard (Cont'd.) Example: 100 microliters of VCM absorbed on charcoal and then desorbed with 5 mil CS^. Injected volume is 5 microliters. 5, 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. Analvtleal G. A. Shaw Deot. U92 D. K. Moore URL 18469 03 H m m OQ URL 18^70 * . i,,MMITS"HAWAKA PLAN'T' VINYL CHL0RI0E SAMPLING DATA TABLE SAMPLE DESIGNATION #18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 "35 36 37 38 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 Calender CF-6 Calender Hopper Car Under Silo (Inside) KoKneader - Mix Area Ensoitte Banbury #2 Sea Id Bin Bldg. 120 Ensolite Banbury 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 RBSIN 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 & 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 WIIIson-CaseItm Pump with Mishawaka 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 and 37* which were static samples. received JUN 13 1974 MED\CAL department EXHIBIT C p. 6 or 8 UNIROYAL, Inc Mishawaka Mi 7 1974 cOM. DKV- Dr. W. D. Harris Oxford URL 18471 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 Kay 31, 1974 report to you. 1 * iyC'Z *1 D. K. Moore Manager, Analytical Services cc: J. R. Sellers INTERCOMPANY CORRESPONDENCE Sample Designation #43 #44 #45 #46 #47 #48 #49 MISHAWAKA PLANT VINYL CHLORIDE SAMPLING DATA TABLE Date 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 Calender Hobart Mixer CP-8 Banbury CP-8 Calender Vinyl Resin In Use VR-23 VR-24 VR-22 VR-22 VR-24 VR-24 VR-24 P.P.M. V.C.M. 2.40 4.00 4.50 1.00 0.80 3.00 0.60 NOTES: 1* Sampling - 0.5 Uters/mlnute for 20 minutes using e 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 Dr. W. D. Harris from L. J. Graeco (G. A. Shaw & D. K. Moore). o nano zt-wnm CD Sample PeaIgnatIon #39 #40 #41 #42 CHICAGO PLANT VINYL CHLORIDE SAMPLING DATA TABLE Data 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 4 VR-24 VR-23 VR-23 & VR-24 P.P.M. V.C.H. 5.96 0.35 1.64 0.35 NOTES: 1. Sampling and testing - performed by G. A. Shaw (Mishawaka) per Mishawaka sampling & testing techniques. 2, This is a first sampling and testing of this plant. a t-s i idn w OB H H &n 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 18474 URL 18475 TEXT D p. 1 of 3 D* Economic Impact 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 (FR, 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 f 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* T." A rough breakdown of application areas follows. (Chemical Marketing Reporter - 5-20-74) Pipe and Fitting Flooring Construction Wire and Cable Furniture Transportation Film and Sheet Textile, Paper and Adhesives Sound Records Export Miscellaneous s : s : : : ; : : : : PVC Use Areas 27% 10 6 9 6 5 4 5 3 5 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. 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 18477 STATEMENT FOR RMA ON VINYL CHLORIDE WALTER D. HARRIS n nA It is most interesting to me to take part in this hearing, One of the^great problems of the past was that we were unable to bring together all that was known about a large social-econoraic-scientific problem and to get balanced action. We have been a nation which sometimes lets the pendulum swing from one extreme to the other. Recent examples are DDT, cyclamates and spray adhesives. As has been pointed out by others, the PVC industry has grown rapidly during the past 35 years. It started at a time when the field of toxicology was not sufficiently advanced to predict long term effects of chemicals on man. No one suspected a chronic hazard from VC. In the light of present knowledge, it is most regrettable that men were exposed to what we now know were much too high concentrations. In spite of strong criticism of industry, I am mildly hopeful that the various segments of our economy are working in what I like to call dynamic tension. If kept within reasonable bounds, this tension can lead to a stronger economy. If the tension becomes too great, it can be destructive. We have here industry pooling resources and information. Universities, hospitals, research groups, labor and government are each > making their contribution. Together we have moved at a rate undreamed of ; even a few years ago. URL 18478 However, there is a danger that we may try to move too fast. Yes, we can live without PVC, the car or the airplane. A few would survive even in the cave. I submit that it is not necessary to destroy an industry because it can't meet an October 5, 1974 deadline which seeks to guarantee absolute safety. No prudent manufacturer knowing that VC is capable of causing cancer will long take the risk of exposing men to concentrations likely to cause harm. Let us not overlook our competitive system. Resin manufacturers will be forced to lower VC concentration by competition. A new criterion has entered the market place and I believe you will see the energies of the large companies turned to solving these problems. Whoever best invests talent and money to build or rebuild plants able to turn out acceptable products with a low level of VC at a profit will stay in business. It Is a sad fact that the small manufacturer will likely fall by the wayside. We have a tendency to over-react in this country. It is all or nothing. If we were to drive FVC off the market what will take its place? Do we know all we should about it? Let us not Jump from the frying pan into the fire. Let us approach this problem even handedly. We have already reduced the highest exposures probably 20 fold. This may already have reduced the problem to a non-hazardous level. Let us challenge industry to compete in finding even better solutions and marshall the best efforts of the industry. Lets 2- - keep alive the dynamic genius which has made America great and not try to operate by force alone. OSHA will never have enough inspectors to enforce an unrealistic standard. There is presently in this country too much dis respect for law. Setting unenforceable standards only increases this disrespect. We believe that an 8 hour time weighted average of 25 ppm is achievable in the near future. During the next two years much new data will be available. We urge OSHA to keep the regulation as simple as you can but build in provision for collection of meaningful data for periodic review. If it is necessary to move lower, some will build new plants to meet the new situation. We challenge OSHA to move creatively, not destructively. WDH/mab 6/27/74 Walter D. Harris, Ph.D. Corporate Industrial Toxicologist URL 18479 I am Walter D. Harris, Industrial Toxicologist for UNIROYAL located at its main office in Middlebury, Connecticut. I have a B.A. degree in chemistry from the College of Wooster in Ohio and a Ph.D. in Organic Chemistry from the Ohio State University. In 1944 I joined the then U.S. Rut - er Company at its Naugatuck Chemical headquarters where I was engaged in research in Agricultural Chemicals for 11 years. During this period I was auchor or co-author of 15 patents and several papers related to this field. For the next 9 years I handled patent liaison and toxicology problems for ~he division. In 1964 I joined the corporate staff where I remain as industrial Toxicologist. In this position, I maintain liaison with Corporate and Divisional research. Plant Management, Corporate Safety and the Medical Departments with respect to overall safety of chemicals. I am Chairman of the Health Sub-committee of the Rubber & Plastics Section, National Safety Council, a member of the RMA Occupational Safety and Health Conmittee and the AIHA Toxicology Committee. I have worked on various ad hoc committees in this field including MCA's vinyl chloride committee. 7 08t>Rl Ib H romoiii Ml : 2 1974 , EEV EXHIBIT D p* 1 of 4 UNIROYAL, Inc. OXFORD D-?-9 (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 $18,500,000* (This value is exclusive of Fringe Benefits) - r The number of employees effected with monthly wage and salary loss by plant is* listed below: URL 18481 PLANT WAGE EMPLOYEES MONTHLY WAGE LOSS SALARIED Elff'LOYEES MONTHLY SALARY LOSS SALESMEN 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 26/6 of their business is derived from the sale of vinyl coated fabrics. j cc: W. J. Mulvey INTERCOMPANY CORRESPONDENCE sts n a n 211 RKV. a-#7 JUN 7 1974 com. dev. EXHIBIT D D* 2 Of UNIROYAL, Inc. Consumer Products Oxford R-l-31 (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. Salary and wage jobs eliminated 216. f \ 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 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 i OJ URL 1848 ------- ~1 uriinoYAL L - --31 UNIROYAL, INC. Route 2, Box 32 Firmvilt, Virginia 23901 June 7t 197U EXHIBIT D p. 4 of 4 RECEIVED JUN 12 1974 D. IHUMSON URL 18484 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 interest the information developing on the Poly Vinyl Chloride problem and have read the proposed rules for emission standards as contained in OSHA Regulation 1910.93Q* 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. f I $ , , .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. ACYssw Factory Manager Uniroyal, Incorporated Farmville, Virginia UHL 1848 Uniroyal Vinyl Chloride and Polyvinyl Chloride Experience TEXT E p. 1 of 2 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 Monochem (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 Ea p. 1). NIOSH 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 1968 1969 1970 1971 1972 1973 1 0 0 1 0 0 0 3 1 1 1 0 2 Vi-r -*? TEXT 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 materialised. 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 B, pp 2-12. URL 18486 an aiv. i-* EXHIBIT E P. 1 Of 12 UNIROYAL, Inc OXFORD {Location) June 14, 1974 TO W. 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. We 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 die 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. Rescreenlng 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 URL 18487 INTERCOMPANY CORRESPONDENCE J CONCLUSION p. 1 of 2 I 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 aero 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 I 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 / nr 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%. URL 18488 (CONTINUED) J CONCLUSION p. 2 Of 2 We do not believe that any schedule of future changes should be written into the initial Standard or should be adopted at this time. Such changes should be instituted only when and if justi fied by data from a properly designed study. And we think it is extremely important to emphasise that such a study, to be valid, must include proper control groups. Before we jump to the con clusion that angiosarcoma is related only to vinyl chloride, or any other agent for that matter, or that the potential for ? development of angiosarcoma is increased by any level of exposure, it should be mandatory that we determine first what the incidence of angiosarcoma is in the general population and how it relates to occupational exposure. URL 13489 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 18490 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 ; w 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. His data are presented in English translation in Tables II and III 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 8T1 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 BT1 at 59 weeks. TABLE II Experimental BTl: Experimental Results at 130 Weeks EXHIBIT B p. 3 of 12 fcroup and Treatment Animals (Rats) S prague-Davley Animals With Tumors Total Living Carcinoma of the Zymbal Nephro Gland biascomas Anaiosarcoma Other Liver Locations Other Types and/or locations Total I Vinyl Acetate 96 - - - -- 2500 ppm - \ II VC 10,000 ppm 69 - 16 4 7 III VC 6,000 ft 72 - 7 ,4 13 2 IV VC 2,500 tv 74 - 2 6 14 3 V VC 500 tl 67 - 3 4 72 VI VC 250 ff 67 1 -- 6 42 VII VC 50 tf 64 3 - - -- VIII Control 68 1 - - - - 6 25 1 24 1 24 1 16 2 12 - - TA1 577 5 28 24 45 9 11 101 URL 18491 o 8 *0 TABLE III Experimental BT3: Experimental Results at 59 Weeks Group and Treatment Animals (Rata) Sprague-Davley Animals With Tumors Total Living Carcinoma of the Zymbal Nephro Gland bias tomes Anaiosarcoma Other Liver Locations Other Types and/or locations Total I VC 10,000 ppm II VC ppm III VC 2,500 ppm 'V VC 500 ppm V VC 250 ppm VI VC SO ppm VII Control 60 60 60 60 60 60 190 36 48 54 56 44 50 183 3 1 -- - ------* - .- . - -3 -1 ----- - TOTAL 550 471 4 4 EXHIBIT B p. 4 of 12 6 Lined - Rfnd. Sc. fis. mat. e nat. - Vol. LVt - marzo 1974 Nellc Tahclle II-VI vengono esposti i dati preliminary relativi agli esperimenti BT 1, BT 3, BT BT 5, BT4. Per quanto conceme gli altri esperimenti dobbiamo attenderc ancora per avcrc risultati. Da quanto presemato nelle Tabelle e dallo studio istologico emergono i Scgucnti punti: 1) il CV e oncu^cno nellc eonditioni sperimentali da noi saggiate: esso provoca carcinomi del.> ghiandole di Zymbal (fig. r), nefrobiastomi (fig. 2) t angiosarcomi epatici (figg. 3, 4) e di altri tessuti ed organi (figg. 5, 6) nel ratto, e adenomi-adenocarcinomi polmonari, carcinomi mammarii e angiosar" comi epatici nel topo.- ( TU Tabella II Espernnento BTi: Risultati sperimentali a IJO settimane Gruppi e TRATTAMEKTI A.vtmali (RATT! SPRAGUE- Dawley) A K1U A L1 COM TUM0R1 Total r- Carcino mi delle NefroSoprav- ghiandole blastoroi vissuti diZymbal <B) (A) Angiosarcomi Fegato cc> Altre localizzazioni Altri tipi e/o Joeaiiz- zazioni Totale (0) N. N. N. N. N. N. I) AV 2.500 ppm > -- -- -- -- -- ---- H) CVio.oooppm 69 -- 16 4 7 -- 6(H) *5 HI) CV 6.000 ppm 7* -- 7 4 *3 2 (D) 1 (I) 24 IV) CV 2.500 ppm 74 j a 6 14 3 (E) t (L) 24. V) CV 500 ppm 67 si " '3 4 7 a (F) i(M) 16 VI) CV 250 ppm 67 1 . -- 6 4 * (C) a (N) 13 VII) CV 50 ppm 64 1 3 -- -- VTU) Xessun trattamento . . . 1 68 1 1 -- ---- | 1 38 Totals . . . 577 5 14 45 9 11 101 i A) Metastasi al polmnne. B) Metastasi al fegato e/o al polmone e alia miiza. C) Metastasi al polmone. D) 1 angiosarcoma in angioma tibrosante sottocutaneo; 1 angiosarcoma osaiAcante auri- colare. 2 angiosarcomi intradduminali (1 viemo alia miiza. 1 vicino aU'ovaio); 1 angiosarcoma ossifirante latcrocervicale. T; 1 angiosarcoma polmonarc: angiosarcoma deU'utero. 0) 1 angiosar* coma intraddominale ,, vicino ali.i miiza); I angiosarcoma ossificante intnuoracico. H) 2 adcuomi dclle ghiandole di Cymbal; 1 neurilemmoma del padtglione auricolare; 2 carcinomi mammarii; l cistoadcnncjrcinoma dcll'ovuiu. I) 1 carcinoma scbaceo della cute. L) t adenoma dclle ghiandole di Zymhal- M) 1 epatomu a minima devmzione, Nx r adenoma dclle ghiandole di Zyrnbal; I car cinoma dclle ghiandule salivstn. O) Divcrsi animali con due o piu tumori. l \ l r X> 0-U0 >12 fO l) c\ ii) c\ HI) o IV) c\ V) c\ VI) C' VII) K ( 59 s* T I) < > pen* lenti <rto i esso > 2) > nel isar' Totals (O) ' N. *5 #4 M l6 12 101 asiasi al rue auri* sarcoma mgiosaradenomi unmarii; hiandole J; 1 car* EXHIBIT E p. 5 Of 12 C. Maltoxi e C. Lefemin'K. Lc pctemiaiita dti saggi sperimentati, tee. 7 Tapella III Uspcrimcnto BT3: Risultati sperimentali a 59 settiman<e (l1 Grcppi E TRATTAM K XT I Aximali (ratti SfKAGl'E* Dawlev) Animali con u-j 0 R I mi dcllc Nefnv Totale Sopravvissuti ghiandole blastoini di ZytnbaJ Angiosarcomi Fegato Altre localizzazioni Ahri tipi e/o tocaliz* zazioni Totale (i> N. N. N. X. N. N. I) CV 10.000 ppm II) CV 6.000 ppm III) CV a.500 ppm IV) CV 500 ppm V) CV 250 ppm VI) CV 50 ppm VII) Kessun tratta* memo .... 60 60 60 60 60 60 190 36 48 54 56 44 50 >83 3 (iO 1 (3) - (1) -- (0 -- -- --W -- (a) -- (0 -- -- -- -- (a) - (3) -- (1) -- (J) -(0 -- _,, -- (0 -- -- -- -- -- (4) 3 (IS) -- * (9) -- (1) -- (5) -- -(a) -- -- (0 ---- Totals . . . 550 471 4 (*7) -- (5) -- (8) -- (I) -- (5) 4 (32) (t) Tra parentesi vit-ne indicato il numcro di tumori riscontrati neU'esperimento BTl, dopo 59 settimanc. (2) Alcuni animali con due tumori. t 6 W [ )an' Tabella IV 4perimento BT6: Risuitati sperimentali a 34 settimane Gruppi s TRATTAMENTI Animali (RATTI SPRACI'SDawley) Aximali cox tumori k Totale Sopravvissuti Carcinomi dcllc ghiandole di Zymbul Xefroblastomi Angiosarcomi Fegato Altre lodliz* zazioni Altri tipi e/o localiz* zazioni Totale N. X. N. N. xN. N. I) CV 30.000 ppm 60 60 2 -- -- . -- 1-------------- -3- EXHIBIT B p. 6 of 12 Total tumors are sunmarized for both BTl and BT3 in simplified form. (1) IC 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 Tabershaw-Cooper report shows number of workers entering the work force where VC was handled either in monomer or polymer plants. Note the rapid growth of the industry in the 50's and 60's. URL 18494 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 ppm. We know that some men were overcome by VC indicating concentrations over* 10,000 ppm. In the late 5Q*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 niosh No. Years In PVC Years From First Exposure to Death 1944 U.S. 05 18 20 U.S. 07 18 24 Ave 25 U.S. 13 30 30 (alive) URL 18495 E X H IB IT E D . 8 O f 12 Table 3 URL 18496 Distribution of Exposed Employment by Year In Which Exposure Began, for 7128 Vinyl Chloride Workers with Completed Follow-up Year Exp. Started Total 1930-39 1940-49 1950-59 1960-69 1970-71 Total 35 1043 1962 3358 715 7128 <60 2 135 389 1714 715 2955 60-119 4 93 257 1442 120-179 1 119 383 195 Months of Exposure 180-239 240-299 300-359 4 151 631 6 277 282 13 237 360-419 Unknown 5 34 2 20 17 1796 698 786 565 250 39 39 April 15, 1974 Year of First Exposure 1945 1946 1948 1949 1950 1951 1952 1955 1957 1962 -4- NZOSU No. u.s. 03 u.s. 09 Sweden 02 U.S. 08 U.S. 11 Gr.Br. 01 U.S. U.S. Norway U.S. Sweden u.s. U.S. V.Ger. 01 12 01 10 01 04 ' 02 01 02 U.S. 06 Total 19 Years In PVC 28 17 23 15 23 20 16 15 21 17 19 15 13 14 11 12 Ave 18.2 BXHIBIT E p. 9 of 12 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 Calive) % 21.3 l Itli t Two points appear likely. (1) The cause of death for some of the people who died from exposures In the early years has not been found. The records for those who died In the 50*s are probably not readily found. -1 ts fid O * HO wH a M 5a ad URL 184!: CONFIRMED CASES 0? LIVER ANGIOSARCOMA AMONG PVC WORKERS tf/cSft -r/jy'/y I ii lr > i COUNTRY CASE 9 United States 01 United States 02 United States 03 United States 04 Unit cd States 05 United States 06 United States 07 United States 08 United States 09 United States 10 United States 11 United States 12 United States 13 W. Germany 01 W. Cernany 02 Great Britain 01 Norway 01 Sweden 01 Sweden 02 BIRTH DATE 1st PVC WORK DX ANGIO SARCOMA 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 03-16-13 05-27-09 ' 11-17-13 12-01-21 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 05-28-45 06-00-51. JO-J4-46 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 03-00-70 05-00-69 05-00-74 00-00-71 00-00-69 12-00-72 12-20-71 00-00-70 00-00-72 AGE AT DX 49 36 58 43 52 45 45 41 43 55 61 50 53 40 39 71 56 43 61 YRS 1st PVC TO DX TOT YRS PVC 22 14 28 15 20 12 24 15 29 17 23 20 30 14 ' 11 26 22 19 27 . 16 n' 28 15 18 12 18 15 17 37 23 ' 15 30 " 14 11 20 21 18 23 DATE Or DEATH 03-03-73 09-20-71 l2-l-73 01-07-68 04-09-64 ALIVE 03-23-68 08-29-61 ALIVE 05-10-68 03-16-70. 05-02-69 ALi*;E 12-14-71 01-25-69 12-00-72 01-04-72 00-00-70 00-00-72 Note: *00' Indicates unknown date Note: In Column titled YRS 1ST PVC TO DX the Mean - 20, the Median - 20 and the Modes " 14, 15, *20, 22, Note: In Column titled TOT YRS PVC the Mean 18, the Median * 17 and the Modes - 15 and 18. \ URL 18499 -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. \ t (From the various reports reaching this country it is likely that exposure in the German plant was particularly high). If ve 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 23 years at 40 ppm, 40 years at 23 ppm, 100 years at 10 ppm, etc. e Our sampling confirms what others are finding that monomer plants generally operate with no 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 areas where the breathing zone level can reach as high as 25-50 ppm but typically no one 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. FVC plants should be monitored periodically in all areas which are frequently -6- EXHIB1X E p. 12 of 12 above TWA of some level such ag/ppm. Sequential samplers should monitor carefully chosen spots as an ongoing check with alarms set when excursions Indicate a leak. WDH/mab 6/17/74 W. D. Harris, Ph. D URL 18500 %