Document L2mJjZ5GqKd8z6QLX2xv6zQX

URL 05738 SUMMARY OF TESTIMONY BY UNIROYAL, INC. IN OBJECTION TO THE PROPOSED PERMANENT STANDARD 1910.93q RELATING TO VINYL CHLORIDE EXPOSURE DOCKET OSH-36 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 am Martin J. Kleinfeld, Commercial Planning Director of the Chemical Division of Uniroyal, Inc. I an a chenist 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 Karris, 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. 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 at 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 600,000 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 05739 | i \ ' \ 4 1' *J INTRODUCTION p. 2 of 3 workers whose jobs would be effected 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 'nave pro duced over 1.5 billion lbs* of PVC and have employed 4out 600 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. Hie 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 level" restriction* This has been detailed in our EXHIBITS Al, 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 Ail) URL 05740 (CONTINUED) I /I INTRODUCTION p. 3 of 3 4) "Emergency" situation vy 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) URL ocn --j .a.  t EXHIBIT A-l p, 1 Of 2 Sunnary of Objections to Specific Sections of Proposed Standard 1910.93q 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 Chances: Occupational health evidence does not warrant imposition of this Standard on all workplaces where a "detectable" level of vinyl chloride nay be present. A "non-dectable" re* striction is technologically infeasible in vinyl chloride onomer and polyvinyl chloride production plants. Some pernitted level which has not been proven unsafe oust 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 utilisation 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. ro URL 0574 / EXHIBIT A-l p. 2 of 2 We recommend that (a) (X) 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. EXHIBIT A-2 p* 1 of 1 Summary of objections to Specific Sections of Proposed Standard 1910.93q Section} (b) (Definitions) (4) (5) Objections 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 05144 EJOUBIT A-3 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 19IO,93q URL 05745 Sections (b) (Definitions) (6) Objections 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 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 Sections (b) (Definitions) (6) Objections 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 05746 i t EXHIBIT A-5 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section; (b) (Definitions) (10) Objections "Semifinished product" Grounds and/or Suggested Changes: Definition needs expansion to include "diced.or pelletized stock" Bade from polyvinyl chloride* URL 05747 , *V_ EXHIBIT A-6 p* 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910*93q Sections (b) (Definitions) (13) Objections Definition of "protective clothing Grounds end/or Suggested Changes: As stated the definition has no practical meaning* Xhe 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* 8w so io n EXHIBIT A-7 p.l of 1 Summary of Objections to Specific Sections of Proposed Standard ]910.93q Section: (d) Regulated areas (1) (ii) Objection: Definition of regulated area involving polyvinyl chloride operations. Grounds and/or Suggested Changes: 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 th*; established permissible level. URL 05749 K EXHIBIT A.8 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Sections (d) (Regulated area?) (3) Objection: Maintenance of 'Maily roster"* Grounds and/or Suggested Changess This requirement is neither practical or useful* It is at least a duplication of effort* Current rime and work records provide information on each employee regarding his activities ai.\ regulated areas* URL 05150 t * EXHIBIT A-9 p. 1 of I Summary of Objections to Specific Sections of Proposed Standard 1910.93q Section: (e) Monitoring (1) (2) Objection: Clarity of definitions. Grounds and/or Suggested Chances: 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 techniques. URL 05751 i EXHIBIT A-10 p. 1' of 1 Summary of Objections to Specific Sectionf of Proposed Standard 1910.93q URL 05152 Section: (f) Engineering controls end work practice methods Objection: Application and need. Grounds and/or Suggested Chanoes: This entire section addresses itself to the need for immediate use of engineering controls and nethods to reduce airborne concentrations of vinyl chloride to aero. Reasons have been previously stated indicating the infeasibility of the zero exposure concept. -We recommend that this section be rewritten to recog nize 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. t EXHIBIT A-ll p, 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Sections (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 hioh 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 My 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. -  y. Summary of Objections to Specific Sections of Proposed Standard 1910*93q EXHIBIT A-12 p* 1 of 1 Sections (h) Protective clothing Objections Definition of proper clothing and removal requirements* Application to polyvinyl chloride* 'Contaminated'1 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 would 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. Mo 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 05754 v EXHIBIT A-13 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q URL 05755 Section: (j) Emergency situations Objection: Definition, Shower requirement. Grounds and/or Suggested Changess ttoergency" is defined (Webster) as: "an unforeseen combination of circumstances or the resulting state .hat calls for immediate action." In any well run operation involving vinyl chloride there already exists a written operational plan for emergency situations. Sr^ll-scale excursions of air concentrations above a permissible level should not be defined as an "eaerger.cy 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. ' ^ 'J / {J'f) lb URL 05756 / EXHIBIT A-14 p. 1 of 1 Summary of Objections to Specific Sections of Proposed St* .Jard 1910,93q URL 05757 Section: (k) Signs and labels Objection: Wording of signs and labels* Grounds and/or Suggested Qianqes: 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 "Hazardousn plus action-oriented instructions in place of "Cancer-Suspect" would accomplish the desired purpose of this secticn* The requirement to wear "full impervious air-supplied equipment,r 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 X Summary of Objections to Specific Sections of Proposed Standard 1910.93q URL 05758 Section: (1) Maintenance and decontamination Objection: Definition of terms: "contaminated" and "decontamina ted" 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 emphasised 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 "whole-body air-supplied" suit* EXHIBIT A-16 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 191093q 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. EXHIBIT A-17 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q S1 ection* (n) Polymer handling operations Objection* "Detectable level" terminology. Grounds and/or Suggested Changes t For reasons previously stated, a "permissible11 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 0.19 - in polyvinyl chloride would add further assurance of insignificant risk to process ing workplaces. URL 05760 / EXHIBIT A-18 p. 1 of 1 Summary of Objections to Specific Sections of Proposed Standard 1910.93q Sections (q) Reports Objection: Definition of "incidents"* Grounds and/or Suggested Changess An "incident" oust be better quantified to avoid overly burdensome and voluminous report requirements covering each Incident involving the 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* TEXT B p. 1. of 1 B* Technological Nonfeasibility Regulations involving protection of workers and their health must recognize the tact that absolute safety in any work situation is impossible* Prom a technical point of view steps ean 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* URL 05762 19571 PoifLANO Avc. Cleveland. Ohio miit Phone 692-0460 Bowshot, Cooper & OfDonneII ENGINEERS June 14, 1974 EXHIBIT B p. 1 Of 2 W. L. COOPER J. f. O'COM NELL I*S7 l*T12 R. K.PICLO 2*17* R. C. SCHACFf CR amts URL 05763 Unlroyai, Inc. P.0. Box 460 Peinesville, Ohio 44077 Attention: Mx. W. H. Illff Plenc Engineer Subject: To reduce the concentration of Vinyl Chloride Monomer in the working areas of your Palnesville 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 gsve careful consideration to the following factors. 1. The "state of the art" at the peasant time doas not permit the measurement of 1PPM of VCK 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 Unlroyai Plant plus marsh gas and automobile contaminants serve to produce a variable "background" chat would make calibration of any continuously monitoring instrument almost impossible to s 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 pocr history for serviceability. It is unlikely chat immediate improvements will be made to Increase their reliability beyond what is new being experienced. 19571 Roselano Ave. CLivEtAm. oh.o *4H7 Phome 692*9460 Uniroyal, Inc. Bowshot, f Coober & O Donnell ENGINEERS June 14, 1974 EXHIBIT B p. 2 of 2 h. u COOATH tine . F. O'OOHNCLL . k. ncuo 24)7* It.C.SCHAEFFER 210*3 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 1002 so that even with current stripping technology some of the mrnomer is included in the final product. Some monomer will be discharged from resin drying systems as veil 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 aoblent 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. 6. The amount of ventilation required to approach 1PPX voul* result in air speeds through the buildings that would cause excessive noise, r 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. Very truly yours, BOWSHOT, COOPER & 0*DONNELL ENGINEERS James F. O'Donnell Partner & Chief Engineer URL 05764 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 wedical 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 enphasis on reducing residual VCM levels in PVC should insure the absence of risk. Data on aonitor'-ng of processing workplaces within Uniroyal aay b* found in EXHIBIT C. URL 05765  * TEXT C p, 2 of 2 Although we reject -f "zero exposure" to vinyl chloride, we rc.* - nd accept - our re sponsibility to protect >e :<eolth of our workers* We believe that low level exposure to vinyl chloride represents minimal risk situation* We recommend that a finite ''permitted level" be substituted in the Permanent Standard in place of the "no detectable" requirement* Zn cur PVC 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* Xt 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 05766 i U&miBHt RECEIVED JUN 31974 MEDICAL DEPARTMENT JVJN i7 1974 wvi EXHIBIT C Pi 1 Of 8 UNIROYAL, Inc. Mishawaka <UcatiMl com. nt**31 1974 Vf. D. Harris Oxford Attached you will find the Initial results of our vinyl chloride sampling and analysis. The complete test method and chromatographic results are included. We will continue the program as we set It up during your recent visit. L. J. Grecco Manager, Technical Services cc: Factory Manager - Mishawaka URL 05767 INTERCOMPANY CORRESPONDENCE ILS. RUBBER / EXHIBIT C p, 2 of 8 UNIROYAL, Inc. Hishawaka (Uutwn) Hay 31. 19?4 U, 0. Harris Oxford Subject: The Determination of Vinyl Chloride-Honomer in Air A method has been developed by the Hishawaka Analytical Laboratory for the determination of VCH in air. Current tests are being done throughout the plant to determine VCH levels. This report will give the analytical method and the valves obtained to date: I Apparatus I. Hewlett - Packard 7620 Gas Chromatograph with flame Ionization detector and recorder. 2* TWo stalntess steel chromatographic columns: e. 10' X 1/8" 10% Silicone SE-30 on diatoport S. b. 20' X 1/8" 10% FFAP on Chromosorb WAN DHCS. 3. 100 microliter gas tight syringe (Hamilton Co.). 4. Air sampling pump. Willson Products Division, ESB incorporated. I 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 plpet. 8. 10 ml glass stoppered volumetric flask. 9. 10 micro!iter syringe (Hamilton Co.). 10. Lecture bottle - pure VC or gas (Hatheson). 11, CSj - Spectro grade (Fisher). URL 05768 INTERCOM PAN/ CCMLSPONDENCE / n X Determination of Vinyl Chloride Monomer in Air EXHIBIT C P. 3 of 8 Page 2 11. Procedure for Samp!Im * 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 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 CS^. Spectral grade CS2 was used in each case. URL 05769 IV. Inlection The solvent flush Injection technique was used to inject S microliters of sample into the G.C. The chromatographic parameters were as follows: Range I02 AttenuatIon 16 Injection Port Detector Oven Hydrogen Flow 200 C 210 C 100 C isothermal Tank pressure 10 psi Air Flow Tank pressure 33 psi Nitrogen Flew 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 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 charcoa I. tube while drawing air with the sampling pump. The charcoal was desorbed with C$2. A description factor is not necessary as both the sample to standard are desorbed by the same method. y % The Determination of Vinyl Chloride Honomer In Air EXHIBIT C p. 4 of 8 Page 3 V. Preparation of a Standard (Cont'd.) Example: 100 microliters of VCH absorbed on charcoal and then desorbed with 5 mil CSj* Injected volume is $ micro!iters. micro!Iters X 100 " 01/ul VCH Injected 5 mil This standard Is called 100 ppm and relates to I mil of air at 100 ppm concentration. The sample peak heights are related to this standard by direct ratio. Analytical 0. A. Shaw Pent. 492 D. K. Moore URL 05770 U VINYL CHLORIDE SAMPLING CF D esignated Coated Fabrics- O OO^NIAIAUSN OM O O 00^N'oNOQ> *MS\o0 *rneO o -WN -NOIAN . , K Uf *8 3 iSi of a NMWNNNNNN IAJ N NmNNNN^ CCCNKNKNKNtfNCNCNtfKNK>N>afItN>eIN>aIcN>aINc >kNI >tNcI eNef. V>aNIe>rti f>NteI >NteI A e 35 Ol <b%--N%b e --x is* 0i la x-- *bV --. o - at S2 * b3 I Xe bo <>a9 "aO > b wa -- z^c ---oe^x .>* to b a bi b "O 'A I O I b b I *A <B 2 c C b o CD 2 93 CbC O 91 XA c AA b cb --b -- A V -- V X Xb C CO A -- AA b> -- ---- WA wAAA A9WBWA 9 ID^9 A AM O a u ul a * > a a aui.u CO CO bO lI V b A ~ "O -- A A ft e O -- O cvoocm ft-oX W A MX I I X I A to ft l AbA c/ <J> b b U. OCO C V C obb Ob Ob C A uuuzoxumuxuuxusu fo fv ro. ^ fk fk fk, fs ro. p-* n (k tk is n fk ^ ^ ^V'k'kNSVkS.osVSNSSNSNNVS Nno Nno NnoNf>0N*vN*>N^NJNJNXMJNJNJNCOINCO NCONCO SO CnO QmmO SmNiANtntN/tVStNmNtANVWNt.lNAU.VU'nki'/kllfStiAStSAISASViNlA.VOUk>A. B jo 5 *d o xiaiHxa O' o - n mj (nc K ffi o ec /mx wwx r*co - -- MNMNNNNNfyNmmmmmmmmm 3s aN 1 ec * I a. K 33 &o s wn A JM Ocl A CL XA AA 4e9-> X*3 N 8k> k$ A Xu 3C C - S'" rAs-> --4* AO u\x O tA. Ae t!n Nm i - .i RECEIVED EXHIBIT C p. 6 or 8 UNIROYAL, Inc. Mishawaka ` . JUN 13 1974 (UeitioA) June 11, 1974 k. ME01CAL DEPARTMENT M i? 1374 C0M- DKV' Or. W. O. Harris Oxford Attached you will find results of our vinyl chloride sampling end enelyses for the: 1* Chicago Plant (initial) 2. Mishawaka Plant (supplemental) The test procedure is outlined in Mr. L. J. Greeco's Kay 31. 1974 report to you. fcX- D. K. Moore Manager Analytical Services ec: J. R. Sellers URL 05772 INTERCOMPANY CORRESPONDENCE Sample Designation #43 #44 #45 #46 #47 #48 #49 urlosti3 MISHAWAKA PLANT VIWTL 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 CP-6 Banbury CP-6 Calender Hobart Mixer CP-8 Banbury CF-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. Sapling - 0*5 Uttn/ilnuti for 20 nlnutos using a Vlllson-Cssella Pump with MliHtviki fabricated S Inch charcoal tubas. 2* All samples attached to operator In breathing sons area. 3. A third week sapling of the major manufacturing areas (except #47). ' 4. This data table la a supplement to the 5/31/74 report to Dr. tf D. Harris from L. J. Graeco (G. A. Shaw & D. K. Moore). " V e x h ib it c p. 7 of 8 /* Samole Designation 039 #40 HI HZ URL 05774 CHICAGO PLAHT VTHYL 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 Hill - On Operator Vinyl Resin In Use VR-24 VR-23 & VR-24 ' VR-23 VR-23 & VR-24 P.P.H V.C.H 3.96 0.35 1.64 0.35 NOTES: 1. Sampling and Casting - performed by G. A* Shaw (Mishawaka) par Mishawaka aampllog 6 Ces clng techniques. 2. This Is a first sampling and testing of this plant* o xiancca & TEXT D a p. 1 of 3 D* Econoaic 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 recognises the validity of econoaic impact arguments in the prologue to carcinogen regulations issued as Part 1910*8 c-p (PR, Vol* 30, 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* tlons 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 recognised 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 05775 * 11 TEXT ] P. * of 3 URL 05776 A rough breakdown of application areas follows* (Chemical Marketing Reporter - 5-20-74) PVC Use Areas Pipe and Fitting Flooring Construction Wire and Cable Furniture Transportation Film and Sheet textile, Paper and Adhesives Sound Records Export Miscellaneous t < s : s t 3 s * : i 27% 10 6 0 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 Painesville9 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 1 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 thae 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 0 we have illustrated some detailed effects that would results within the Uniroyal organisation. URL 05777 JUH 131974 cev. EXHIBIT O p. I Of 4 uniroyal,inc. OXFORD D-2-2 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 Royelite ABS-Thermoplastic Sheet operations if the proposed Government standard of "zero" or "no detectable level" of vinyl chloride exposure is snde 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 HONTHIY SALARY LOSS SAU5SMEN Chicago, HI. 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, U6 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 ts 26% of their business is derived from the sale of vinyl coated fabrics. URL 05778 J ccs W. J. Mulvey i JUN 7 1974 com. dev. EXHIBIT D p. 2 of UNIROYAL. Inc. Consumer Products .1 I Oxford R-l-31_______ (UWMft) June 6, 1974 TO: K. J. Dowling Naugatuck Chemical Division FROM: F. C. Cesare SUBJECT: Proposed VCM OSHA Regulation #1910.93q Rc: 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. Value of wages and salary in dollars Si,600,000* The loss of S2,600,000 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 -jver $4 million and the elimination of JOO salary and wage positions. The value of salary and wages is S870,000 and the materials and overhead dollars which would be lost to the community is estimated at 3366,000. Since tlw 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 t^e loss in net sales would amount to 312,000,000,thr salary and wages lost would be approx imately 33,565,000. The materials and overhead dollars lost to the local community and vendors would be $1,335,000. The total number of positions eliminated asLuming complete plant close down would be 416. URL 05779 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. Dudrov F. C. Cesare U R L05180 r--n UMIROYAL laalJ UNIROYAL, INC. Rout* 2. Boi 32 Fftrmvill*, Virginia 23901 June 7, 1974 EXHIBIT O p, 4 of 4 RECtiVEb JUN12 1974 0. JHUMSON Mr. John Stender Assistant Secretary of Labor U. S. Department of Labor Washington, D. C. 20210 Dear Hr, Stender: Ve 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 0SHA 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. $ , , .The material cost for manufacturing our products approximates 1 600 000 Ve 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 05781 ACY:aw aTCT Young Factory Manager Uniroyal, Incorporated Farmv 11lo, Virgin1a TEXT B p. 1 of 2 Uniroyal Vinyl Chloride 3. and Polyvinyl Chloride Experience UF>i 05782 We started making both VCM and PVC in Fainesville, 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 aeetylene 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. 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 O 0 1 O 0 O 3 1 1 1 0 2 TEXT E p. 2 of 2 ? Since more end 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 recognised that more vinyl chloride related deaths could come in the future but me believe it is scientifically reasonable that these occurrences will also relate to earlier extensive exposures to high levels. fhe relatively recent overall industry reductions in exposure coupled with future . mandatory reductions should eventually reduce the hasard to a minimal risk situation* We do not believe that the available human medical evidence warrants reduction of worker exposure to 'tan-detectable levels"* Experiments with animals may suggest levels of potential hasard 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 toxieological 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 05783 rati act. <' i EXHIBIT B p. 1 of 12 UNIROYAL, Inc OXFORD (tKAUont June 14, 1974 TO: FROM: V. D. Harris J. D. Forbes, H.D. SUBJECT: MEDICAL RESULTS FROM FAINESVILLE Ever since the description of acroosteolysls, ve 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 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 angiosareoma, we have found no cases In Paineavllle to date. Ve have followed the NIOSH medical surveillance reconsnendations 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, SCFT, end CGTF.) 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 teats. Resereenlng results have returned on less than half of these 46 with the result that all of them continue to show a persistence of one or more abnormalities. Thus It would appear with our testing still under way Chat those who will deserve an extended and Individualised 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 (15.9T) shoved one or more abnormalities. Resereenlng is presently in progress. JDF/mab io n INTERCOMPANY CORRESPONDENCE ' EXHIBIT E STATEMENT RE "DETECTABLE LEVELS" P# 2 of 12 URL 05785 The concept of "detectable levels" Is unrealistic and meaningless, JU.'dvare 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 aueh low levels. TOXICOLOGICAL DATA We are Indebted to Prof. Cesare Maltonl for his exeellant 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. Maltonl extended and greatly refined these studies. Bla data are presented in English translation in Tables II and III which follow. The complete tables from which these date were taken are from a paper by Cesare Maltonl and Gulseppe Lefemine, Eatratto dal fasc, .3, Serie VIII,'Vol. LVI, and Marso 1974 are given untranslated In the pages which follow our tables. Experiment 9T1 Involved exposure of animals at Che various concentrations for 52 weeks end observation until death. At tho 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 tracks. 1t I URL 05786 TABLE II Sxpsrlatntal BTl: Experimental Result* at 130 Weeks EJHISIT B p. 3 of 12 fcroup and Treatment Animal* (Rats) Bprague-Dawliy Aalsals With Tiaaors Total Living Carcinoma f the Zyabal Kephro Gland blestoaas Anclotareoma Other Liver Locations Other Type* end/or locations Total z Vinyl Acetate 2500 ppa XX VC 10.000 ppa 111 VC 6,000 m 1? VC 2,300 m V VC 300 n VI VC 350 n VII VC 30 m VIII Control 96 69 72 74 67 67 64 68 - 1 3 1 - 16 7 2 3 -- - 0 4 > 6 4 * - - .- 7 13 2 14 3 72 42 --- 6 25 1 24 1 24 1 16 2 12 --- IAL 377 5 28 24 45 9 11 101 TABLE III Experimental BT3: Experimental Results at 39 Weeks Group and Traatmant Aalaels (Rats) Sprague-Davley Aalaels With Tmors Total living Carclneaa of tha Zyabal Nephro Gland blas eoass Anelossrcoma Other Liver Locations Ocher Typee and/or locations Total S VC 10,000 ppa 60 11 VC 6,000 ppa 60 HI VC 2,500 ppa 60 *V VC 500 ppa 60 V VC 250 ppa 60 VI VC 50 ppa 60 VII Control 190 36 48 54 56 44 50 183 3 1 -- .- m m mm m m m m cb mmm mmm m m -3 -1 ----- - TOTAL 550 471 4 m m m4 * *> * 6 Uneet - R-nd. Sc fit. mat. c naL - Vo!. LV1 - mars* 1974 EXHIBIT fi P. 4 of 12 NellcTabcllc II-V1 vcngono csjx>sti i dati jircliminari relative agli cspcrimcnti BT i, BT 3, BTt\ BT 3, BT4. Per quanto concerns gli altri esperimen dobbiamo attendere ancora per avcrc risultati. Da quanto presemato nolle TabcUc e datlo studio istologico emergono i seguenti punti: 1) it CV b oncojjcno ncllc condizioni spenmentali da not saggiate; esso provoca carcinomi dcl'e ghiandole di Zymbal (fig. 1), nefroblastomi (fig. a) d sngiosarcomi epattci (figg. 3, 4) c di altri tessuti ed organi (figg. 5, 6) net ratio, e adcnomi-adcnocorcmomi polmonari, carcinomi mammarii e angiosar" com: cpatici net topo; *. G*it * n*ru\ URL 05787 Tabella II Esperirntnio BTt: Risultati spcrimentali a JJO settitnane Ctmi X TZATTAMEKTI I) AV 3400 ppm ID CVtoooo npm AVtXALl )MTTI&nACCS> DAV.TKY) AKIMALt CO* Tl'UOKI Careino- 1 T* ouJr*|1 s^mrrntiu mi delle phiandole di Zymbal blastemi (B) (A) Anfiesarcoim Fcgato (Q Altre localii* zaxiooi Altri tipi e/o localiz* TotaJe sazioni (0) 1 K. N. N. N. N. N. J > __ __ _ _ __ -- -- *9 -- 16 4 7 -- 6(H) s$ HI) CV 6.000 ppm 7* -- 4 13 * (O) < (I) S4. IV) CV 3.500 ppm 74 s V) CV 500 ppm _ *7 *3 VI) CV 350 ppm 67 1 -- 6 *4 3(E) I (L) *4. 4 7 * (F) KM) |6 6 4 * <C) * (N) IS VII) CV 50 ppm 64 5 -- -- -- -- -- -- V1U) Nmun tmta* memo . . . tt 1 -- -- -- -- -- --' Totals . . . 577 5 si *4 45 II IOI A) Mfiauati al potmoc*. U) Mcutuii a! frgato r.'o al polmnne * alia rnilza. Q Motattati a) polmone. D) l anpioMrcMiu in Mpoma iibrotante wHiocwiante; t aniiio'Mcenui Miiiinnic auri* Cotarc. El 2 an(H<saMNi iirtradtlwmmali {1 vinno alia milia. 1 vieiuo .tH'pvaio;; 1 angiouitma wilitMir iurRKtrvi{lr. I~: l in;'wuirntt ptlatmarr; 1 angiotareoma riell'iitero. C) 1 an^iovw* coma iniradilomitialc vicino alU miiza'; 1 ancHnarcMM MtiAcanie imraiorariro. tl) 3 adenomi delk ghiaiMlwh di Zymbal; t neurilemmoma del p.idcimnr aurieptan*; 2 carcinomi mammarii: 1 ctanadrnicarrmotna dcH*o\uiu. ll 1 carcinoma Hmoo della cute. L' 1 adenoma Jrlle ghnndole di Zyml*al. M't rpsiunu a minima tlrviaxmnc. S' l adenoma drib phiamlole di ZymbaJ, t car* cinooii drlle ghuniiiilt ulnan. O; linriii auimati Con due o piii tumori. I) CV 101 II) CVfeo tit) CVt.p IV) CV joe V) CVtjc VI) CVjo VI!) Kama meats Tota $9 tettima G* TSAT1 l) CY> EXHIBIT E p. 5 pf 12 C. MALTOXl e C. rjEfCMIXK. Li pmttmsialit* dri Wfgi t^triinentati, ict. 7 Tabella III HtptrimtHto BTj: Rixuttuti tp<rimcHt>\li a ft xettimmu n> Ctvm % nATTA)IU(TI ANIMAL! (ATTI Srtt tCl'L- Hawley) AXIMALI COX TUMORI rotate Soprav* riuwti mi ilrlle Nefrtw eiiiandolc Wastomi uiXymbal A{ittRomi Akre Fiyuo localit* tttioni Attn tipi e/o incalit* tasioni Totale K. H. N. X. N. X. t) CV 10.000 ppm II) CV 6x00 ppm III) CV 9.500 ppm IV) CV $00 ppm V) CV 950 ppm VI) CV jo ppm VII) Kmun tntu* memo .... 60 60 to to to to 190 36 4* P l* 44 So 3 3 In) (3) -CD "(0 -- -- -- CD -CD -(0 -- -- -- -- CD - (3) "(0 -- 0) -0) -- -- -- CD -- -- -- -- - H) 3 (i$> -- ' l CD -CD -(5) -- -- CD -- -CD ---- -- Totals . . . SJO 47* 4 (17) -<S) -(*) -CD -- (SI 4(3*) (t) Ti* parcnteii vicne indicato it numero <li tumori ritconlnt* neU'eiperimento BTi, dopo {9 iettimanc. (2) Akuni animali con due tumori. --ggcssa^^a-- URL 05788 Tabella IV Etperimento BT6: Risuitati tptrimrutali a 34 srttimanx Gaum TutTAiimi . Aximali (RATTI SPIUCtC- Hawley) Aximali cok tumori % Circiflo Totals Soprav. vmuti mi iklle Nefroghiamtotr Uaatonti iliZytntai Anpiosarcomt Akre Fcpaie localiz* tuioni Altri tipi e/o loealis* Totale aatiortt K. N. N. X. X. N. I) CVjMeoppm to to t ---- -- 1V .4 .. . .3. EXHIBIT E p. 6 of 12 ' Total tumors are susssarlsed for both BT1 and BT3 In simplified form. (1) It is obvious that the critical concentration range in experiment BTl is j. 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 Tabershav-Cooper report shows number of workers entering the work 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 05789 Most of the angiosareoma 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 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 wet.: used as monitors so the available data is not precise. The Identification of aeroosteolysls 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 NZ0SH. Year of First Exposure M10SH No. Years In PVC Years From First Exposure to Deaeh 1944 U.S. 05 18 20 U.S. 07 18 24 Ave 25 U.S. 13 30 30 (alive) oaiM E X H IB IT E p . 8 o f 12 URL 05791 Table 3 Distribution of Months in Exposed Employment by Year In Which Exposure Began, for 7128 Vinyl Oilorlde Workers vlth Completed follow-up Year Exp. Started Total 1930-39 1940-49 1950-59 1960-69 1970-71 35 1043 1962 3368 715 Total 7128 <60 2 135 389 1714 715 2955 60-119 4 93 2S7 1442 120-179 1 119 383 195 Months of Exposure 180-239 240-299 300-359 4 6 13 151 277 237 631 282 360-419 5 34 Unknown 2 20 17 1796 698 786 565 250 39 39 k April 15, 1974 .t \ Year of First Exposure 1945 1946 1946 1949 1953 1951 1952 1955 1957 1962 4 NIOSH No. D.S. u.s. Sweden u.s. D.S. 6r.Br. 03 09 02 08 11 01 U.S. D.S. Norway D.S. Sweden D.S. D.S. tf.Ger. 01 12 01 10 01 04 ' 02 01 02 D.S. 06 Total 19 Years In FVC 28 17 23 15 23 20 16 15 21 17 19 15 13 14 11 12 Ave 18.2 EXHIBIT E p. 9 of 12 Years From First Exposure to Death 28 29 Ave 28 27 15 23 Ave 22 27 Average to here 2S 25 20 22 17 19 15 16 14 11 12 (alive) 4 21.3 Two point* appear likely. (1) The eause of death for some of Che people who died from exposure* In che early years has not been found. The records for those who died in the 50's ere probably not readily found. c* Ui O HO M CO H* aj a ai URL 05793 .. CONFIRMED CASES OF LIVER ANGIOSARCOMA AKOKG PVC WORKERS COUNTRY CASE 8 United States 01 United States 02 United States 03 United States 04 United States 05 United States 06 United States 97 Vn11 od States 08 United States 09 United States 10 United States 11 Unit ed States 12 United States 13 W C-raany 01 W. Cerneny 02 Croat Britain 01 No rway 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 08-J6-13 05-27*09 * 31-17-18 12-01-21 07-26-31 06-04-39 09-00-01 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 C8-00-44 10-97-46 05-28-45 06-00-51. JO-J4-46 09-33-49 08-19-44 * 10-14-57 * * 30-01-57 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 05-09-68 03-00-7Q 05-09-69 05-00-74 ' 00-00-71 00-00-69 12-00-72 12-20-71 00-00-70 00-00-72 ACE . YRS AT 1st PVC DX f TO DX TOT YRS PVC 49 22 16 36 14 11 % 58 26 26 43 15 15 52 20 , 18 45 12 12 45 24 18 41 15 43 29 IS J7 55 37 37 61 . 23 23 50 20 *15 .53 30 40 14 30 * 14 39 * H 11 71 26 20 56 22 21 43 19 18 61 27 2? Koto: Note s Note: CO' indicates unknown date In Column tided YRS 1ST PVC TO DX tlia Mean - 20, the Median - 20 And the Modes In Column titled TOT YRS PVC the Keen 18, the Median 17 end the Modes 15 an DATS OF DFATH 03- 03-73 09-28-71 12-l-73 01-07-68 04- 09-64 ALIVF 03-23-68 08-20-61 ALIVE 03-10-68 03-16-.7 CL 05- 02-69 AU? 32-14-71 01-25-59 32-00-72 01-04-72 00-00-70 00-00-72 15/20, 22 /-* 5- EXHXBZT p. 11 of 12 (2) Additional eases 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 eases 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 ve find a Vest German worker who died after only 11 yeers exposure. Assuming 1000 ppm TVA exposure ell fall between 11,000 and 30,000 ppm years. (From the various reports reaching this country It is likely that exposure In the Carman plane was particularly high). If we apply a liberal safety factor of 10 (remembering that we are using huaan data so thara 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 st 25 ppm, 100 years at 10 ppm, etc. r 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 sxmltorlng in these plants can be greatly restricted, limiting it to those areas shown by preliminary study to have the highest levels. PVC plants should be monitored periodically in all areas which are frequently !\' URL 05794 i / 6- &XHXBIT p. 12 of 12 ay^fm, bov 1WA of leoe level such Sequential samplers should monitor carefully chosen spots as an ongoing check with alarms set when excursions indicate a leak. VDH/nab 6/17/74 V. D. Harris, Ph. 0 >* \ CONCLUSION p. 1 of 2 Z think that the testimony and comments presented at this hearing should have Bade it clear to all of us who are concerned with the health of ind of the economy that the precipitate action proposed in the Permanent Standard would not be in any one's bent interest* Z 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; X want to get the risk down as low as feasible, so low that X wouldn't hesitate myself to take that employment* But I don't want to make it so low that X 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 time weighted average of ^5cTppa)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*15. \ \ URL 05796 (CONTINUED) * CONCLUSION p. 2 of 2 W do sot 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 angiosaxoma is in the general population and how it relates to occupational exposure*