Document 1yD3x06nvEJ6BDKwRMgr48Kmq

STATEMENT OF JOHN E, ERTEL GENERAL MANAGER, ROBINTECH INCORPORATED PREPARED FOR PRESENTATION AT DEPARTMENT OF LABOR HEARINGS ON VINYL CHLORIDE; OCCUPATIONAL EXPOSURE STANDARD JUNE 25, 1974 JUDGE MYATTj . I am John E, Ertel, presently General Manager of Robintech Incorporated, headquartered in Fort Worth, Texas, PVCRobintech is a manufacturer of resin in PVCPainesville, Ohio and has a second plant under con struction in Freeport, Texas, Robintech is also a large PVCmulti-plant manufacturer of pipe, fittings and vinyl siding. 1950,Since I have been in the employ of three PVCmajor producers, two of which were also fabricators, AS A DEVELOPMENT ENGINEER, SENIOR PROCESS ENGINEER, PUNT manager. Vice President of Production and most recently General Manager. During the period from 1950 to 1965 my job assign ments not only resulted in daily exposure to vinyl chloride SPl-04808 UCCLEW08 -2- AT LEVELS FREQUENTLY DETECTABLE BY SMELL* BUT ALSO RESULTED IN AN INTIMATE FAMILIARITY WITH ENGINEERING TECHNOLOGY AND WORK PRACTICES OF THOSE TIMES, Since the announcement of recent findings suggest ing A LINK BETWEEN VINYL CHLORIDE AND ANGIOSARCOMA OF THE LIVER; I HAVE DIRECTED EXTENSIVE PROGRAMS ON BEHALF OF MY COMPANY TO DISCERN THE THEN CURRENT EXPOSURE LEVELS; THE REASONS THEREFOR; AND TO INITIATE ENGINEERING AND WORK PRACTICE CHANGES TO MINIMIZE THIS EXPOSURE. I HAVE ALSO HAD OCCASION TO MEET IN VARIOUS INDUSTRY TECHNICAL SESSIONS HELD UNDER SPI AUSPICES WITH OTHER VCM AND PVC PRODUCERS7 REPRE SENTATIVES SCHOOLED IN MANY RELEVANT DISCIPLINES. In SUCH SESSIONS WE HAVE ATTEMPTED TO REVIEW PAST PROCESSES; WORK PRACTICES AND VCM EXPOSURE LEVELS IN THE WORKPLACE. From June 17 to June 19; 1974 a subcommittee of the Vinyl Chloride and Polyvinyl Chloride Producers Com mittee WAS CONVENED AND MET IN SPRINGFIELD; MASSACHUSETTS FOR A THREE-DAY *PROBLEM ANALYSIS* CONFERENCE. THE PLAN WAS TO UTILIZE THE KEPNER-TREGOE PROBLEM-SOLVING AND DECISION-MAKING ANALYSIS PROCEDURE APPLIED TO DATA AND INFORMATION WHICH WERE AVAILABLE AND RELATED TO THE 13 ANGIO SARCOMA CASES KNOWN TO HAVE OCCURED WITHIN THE RANKS OF THE \ VINYL CHLORIDE-POLYVINYL CHLORIDE MANUFACTURING WORKING SPI-04809 UCCLEW0818 3- - FORCE IN THE UNITED STATES, INCLUDED ALSO WERE SIMILAR; COMPARABLE DATA AND INFORMATION RELATING TO VINYL CHLORIDE AND POLYVINYL CHLORIDE MANUFACTURING FACILITIES WHERE CASES OF ANGIOSARCOMA HAVE NOT BEEN DETECTED, AlL OF THE COM PANIES WHICH HAD REPORTED ANGIOSARCOMA CASES WERE REPRE SENTED AND A MAJORITY OF THE OTHER PRODUCERS PARTICIPATED FULLY. For the benefit of those who are not familiar with THE KEPNER-TREGOE PROBLEM-ANALYSIS AND DECISION-MAKING PRO CEDURE; IT MAY BE HELPFUL TO EXPLAIN THE PROCESS AT THIS POINT, The PROCESS CONSISTS OF ASSEMBLING THE AVAILABLE INFORMATION PERTAINING TO A DEFINITE PROBLEM OR CONCERN IN A STRUCTURED FASHION, THE CONFERENCE LEADER WHO IS TRAINED IN THE PROCEDURE ATTEMPTS TO ASSURE THAT ALL THE PARTICI PANTS HAVE AN OPPORTUNITY TO CONTRIBUTE UNDER CONDITIONS THAT OPTIMIZE THE FREE EXCHANGE OF DATA AND OPINIONS, During the course of the analysis, it becomes possible to MORE CLEARLY DEFINE WHAT THE SITUATION IS AND WHAT IT IS NOT. Following the information acquisition portion of THE ANALYSIS, A STRUCTURED SOLUTION PROCESS OF DEDUCTIVE REASONING IS FOLLOWED TO MAKE IT POSSIBLE TO REACH CONCLUSIONS ABOUT CAUSE AND EFFECT RELATIONS AND TO DEVELOP SOLUTIONS WHICH TAKE INTO CONSIDERATION ALL THE AVAILABLE INFORMATION, SPl-04810 UCCLEW0819 The Kepner-Tregoe process is described in a text PUBLISHED BY McGRAW"HlLL ENTITLED "The RATIONAL MANAGER*' AND WRITTEN BY DRS. KEPNER AND TrEGOE, THE ORIGINATORS OF THE SYSTEM, THE KEPNER-TREGOE METHODS OF PERSONNEL TRAINING IN AREAS OF PROBLEM-SOLVING AND DECISION-MAKING ANALYSIS IS THE ONE MOST WIDELY USED BY U. S. INDUSTRY, This system is also employed extensively by governmental AND INVESTIGATORY BODIES, EXAMPLES OF THESE.USES INCLUDE THE USE BY THE ClYIL AERONAUTICS BOARD IN DETERMINING CAUSES OF AIRCRAFT ACCIDENTS, IT IS ALSO USED BY NASA TO RESOLVE PROBLEMS ARISING IN VERY COMPLEX AREAS, TWO SPECIFIC EXAMPLES HAVE BEEN BROUGHT TO MIND, ONE WAS A RESOLUTION OF THE CAUSE OF THE FIRE IN WHICH THREE ASTRO NAUTS WERE KILLED. ANOTHER EXAMPLE OF ITS USE BY NASA WAS IN THE SUCCESSFUL RESOLUTION OF THE CAUSES OF A MALFUNCTION THAT AROSE AT THE LAUNCHING OF APOLLO 13. I AM ATTACHING AN UNEDITED SET OF'WORKING NOTES USED BY OUR CONFERENCE GROUP, THE NOTES REPRESENT A COL LECTION OF DATA; OPINIONS AND SPECULATIONS THAT FORMED THE INPUT FOR THE ANALYSIS AND ARE SUBMITTED FOR THE RECORD SO THAT INTERESTED PARTIES CAN BE FULLY AWARE OF THE INFOR MATION UPON WHICH THE CONCLUSIONS ARE BASED. SPI-04811 UCCLEW0820 - 5- In light of the fact that some of the key issues HERE CAN ONLY BE DEALT WITH IN TERMS OF PROBABILITIES, AS Mr. Heckman noted in his statement, we believe that the INFORMATION ASSEMBLED CONSTITUTES A CONTRIBUTION TO THE BODY OF KNOWLEDGE AVAILABLE, AND THAT IT DOES PROVIDE A SIGNIFICANT AND RELEVANT FOUNDATION FOR REASONED CONCLUSIONS, With this premise clearly understood, the following CHARACTERIZATIONS WERE ESTABLISHED FROM THE AVAILABLE CASE HISTORIES OF THE AFORESAID 13 CASES OF ANGIOSARCOMA: 1, Each individual case was exposed to VINYL CHLORIDE FOR A MINIMUM OF 12 AND A MAXIMUM OF 30 YEARS PRIOR TO DIAGNOSIS. 2, Each individual case was exposed to HIGH TIME WEIGHTED AVERAGE (TWA) EXPOSURE TO VINYL CHLORIDE FOR A MINIMUM OF TEN AND A MAXIMUM OF 28 YEARS. 3, OF THE 13 ANGIOSARCOMA CASES, 12 WERE EMPLOYED FOR MANY YEARS IN POLYVINYL CHLORIDE MANUFACTURING PLANTS, AND ONE IN A VINYL CHLORIDE PLANT. THE UTTER WAS EMPLOYED FOR A BRIEF PERIOD OF TIME IN A POLYVINYL CHLORIDE PUNT AS WELL. A. None of the 13 cases were reported TO HAVE HAD ACROOSTEOLYSIS (AOL). SPl-04812 UCCLEW0821 6- - 5. NO AGENT OTHER THAN VINYL CHLORIDE MONOMER WAS FOUND TO BE CONSISTENTLY RE LATED TO THE 13 CASES, 6. Four of the ten fatal angiosarcoma CASES WERE DETECTED ONLY UPON RETROSPECTIVE EXAMINATION OF HISTOPATHOLOGIC PREPARATIONS FROM THE AUTOPSY AT THE TIME OF DFATH. 7. NO MAINTENANCE PERSONNEL SUCH AS PIPEFITTERS, ELECTRICIANS AND THE LIKE WHO COULD HAVE BEEN EXPOSED TO HIGH LEVELS OF VINYL CHLORIDE MONOMER WERE AMONG THE 13 CASES. AS A RESULT OF THE CHARACTERIZATION OF THESE 13 CASES AND CONSIDERING THE OTHER AVAILABLE INFORMATION PRE' SENTED IN THE ATTACHED SUMMARY, THE FOLLOWING CONCLUSIONS WERE REACHED: 1. All 13 cases of angiosarcoma of THE LIVER WERE EMPLOYEES WHO HAD BEEN EX POSED OVER LONG PERIODS OF TIME TO CONTIN UOUS HIGH LEVELS OF VCM. THESE LEVELS WERE FREQUENTLY ABOVE THE ODOR THRESHOLD AND WERE ESTIMATED TO BE A MINIMUM OF 500 PPM j TWA AND MAY HAVE BEEN AS HIGH AS 2,000- 4,000 TWA.ppm There is some controversy SP1-04813 UCCLEW0822 -7- IN THE LITERATURE AS TO WHAT THE ACTUAL THRESHOLD LEVEL IS FOR THE OLFACTORY DE TECTION OF VINYL CHLORIDE. ONE SOURCE REPORTS 250 TO 500 PPMj ANOTHER USES AN APPROXIMATE MOO PPM FIGURE. MOREOVER, THE 2,000 TO 4,000 PPM FIGURE IS SUPPORTED BY RECENTLY GENERATED EVIDENCE FROM VERY SIMPLE EXPERIMENTS DEMONSTRATING THAT THE ODOR THRESHOLD IN INDIVIDUALS WITHOUT PRE VIOUS EXTENSIVE EXPOSURE TO VCM IS APPROXI MATELY 2,000 PPM WHILE TKE DETECTION ODOR THRESHOLD FOR INDIVIDUALS WITH CONSIDERABLE PREVIOUS VCM EXPOSURE IS INDICATED TO BE APPROXIMATELY 4,000 PPM. 2. The data reported last February by Dr. MaLTONI INDICATES THAT THE DEVELOPMENT OF ANGIOSARCOMA IN RATS IS DOSE RELATED. 3. The preliminary data reported in April by Industrial Bio-Test Laboratories, WHEN COMPARED WITH THE MALTONI DATA FOR RATS, SUPPORTS THE DOSE RELATIONSHIP CON CLUSION, BUT ALSO SUGGESTS A SIGNIFICANT DIFFERENCE IN SPECIES RESPONSE. THE IN DUSTRIAL BlO-TEST MICE APPEAR TO BE MUCH MORE SENSITIVE THAN MALTONl'S SPRAGUE- SPI-04814 UCCLEW0823 8- - Dawley rats, although it should be recog nized THAT EXPOSURE CONDITIONS IN THE TWO CASES WERE SOMEWHAT DIFFERENT. 4. Even if it is assumed that the 13 REPORTED CASES WERE CAUSALLY CONNECTED TO VINYL CHLORIDE EXPOSURE, THE EXAMINATION OF THE MALTONI DATA AT LEVELS OF 250 PPM AND HIGHER COMPARED WITH THE HUMAN EXPERIENCE AT LEVELS SIGNIFICANTLY HIGHER THAN 250 PPM INDICATES THAT THE SpRAGUE-DAWLEY RATS ARE SIGNIFICANTLY MORE SENSITIVE TO THE DEVEL OPMENT OF LIVER ANGIOSARCOMA THAN HUMANS. 5. It was our conclusion that the EMERGENCY TEMPORARY STANDARD WHICH SET THE MAXIMUM EXPOSURE TO VINYL CHLORIDE IN THE WORKPLACE AT 50 PPM APPEARS TO ASSURE THAT EMPLOYEES WILL NO LONGER BE EXPOSED TO ANY UNDUE OCCUPATIONAL HAZARDS. It SHOULD BE NOTED, HOWEVER, THAT ADDITIONAL ANGIOSARCOMA CASES FROM AMONG THE VINYL INDUSTRY WORKFORCE ARE LIKELY TO BE REPORTED OVER THE NEXT TEN OR TWENTY YEARS DIE TO THE FACT THAT THERE ARE STILL MANY VETEFAN WORKERS EMPLOYED WHO HELD THEIR JOBS DURING THE 1940'S, 1950'S AND EARLY 1960'S. SPI-04815 UCCLEW0824 9- In this connection, it was also.pointed out during our sessions that the new attention being focused on angio sarcoma of THE LIVER, EB. S, IS VERY LIKELY TO LEAD TO INCREASED DIAGNOSIS OF THIS CONDITION IN THE GENERAL POPU LATION. IN THE PAST, DIAGNOSIS OF THIS DISEASE WAS EXTREMELY LIMITED FOR ANY NUMBER OF REASONS. DIAGNOSIS OF ANGIOSARCOMA AS A CAUSE OF DEATH REQUIRES THOROUGH HISTOPATHOLOGIC EXAM INATION OF THE LIVER IN ADDITION TO REQUIRING GENERAL AUTOPSY AND PREPARATION OF SLIDES, THE EXAMINATION REQUIRES AN AWARENESS OF THE DISEASE SYNDROME AND A WILLINGNESS TO COMMIT TO IT AS A DIAGNOSIS. THERE HAVE BEEN RECORDED INCIDENCES WHERE CAUSE OF DEATH WAS ATTRIBUTED TO A GENERAL HEPATOMA AND UPON SUBSEQUENT RE-EXAMINATION BY SKILLED INDIVIDUALS WITH A HIGH AWARENESS OF ANGIOSARCOMA, IT WAS DETERMINED THAT THE DECEASED PERSON HAD DIED FROM ANGIO SARCOMA. IN SHORT, IT WOULD APPEAR REASONABLE TO ASSUME THAT THE MUCH DISCUSSED RARITY OF THIS DISEASE MAY WELL HAVE BEEN OVERSTATED WITH RESPECT TO THE GENERAL POPULATION. It would be unwise to puce great reliance on the 25 cases PER YEAR FIGURE FOR THE GENERAL POPUUTION SO WIDELY PUBLI CIZED IN THE PRESS AND ELSEWHERE AS AN AVERAGE AS A BASIS FOR COMPARING THE OCCURENCE OF THE DISEASE IN THE GENERAL SPt-04816 UCCLEW0825 - 10 - POPULATION WITH ITS OCCURENCE AMONG WORKERS IN THE VINYL CHLORIDE AND POLYYINYL CHLORIDE PRODUCING INDUSTRIES. SPI-04817 UCCLEW0826