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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 HYATT: 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 MULTI-PLANT MANUFACTURER OF PVC PIPE, FITTINGS AND VINYL SIDING. 1950,Since I have been in the employ of three MAJOR PVC PRODUCERS, TWO OF WHICH WERE ALSO FABRICATORS, AS A DEVELOPMENT ENGINEER, SENIOR PROCESS ENGINEER,. PLANT MANAGER, VlCE PRESIDENT OF PRODUCTION AND MOST RECENTLY General Manager, 1950 1965During the period from to my job assign ments NOT ONLY RESULTED IN DAILY EXPOSURE TO VINYL CHLORIDE RSV 0002539 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 PRODUCERS` 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. 17From June 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 RSV 0002540 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 FRODUCERS 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. RSV 0002541 4- - 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 ClVIL AERONAUTICS BOARD IN DETERMINING NASAcauses of aircraft accidents. It is also used by 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. RSV 0002542 5- - In light of the fact that some of the key issues HERE CAN ONLY BE DEALT WITH IN TERMS OF PROBABILITIES, AS Hr. 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 LATTER WAS EMPLOYED FOR A BRIEF PERIOD OF TIME IN A POLYVINYL CHLORIDE PLANT AS WELL. 4. Hone of the 13 cases were reported TO HAVE HAD ACROOSTEOLYSIS (AOL). RSV 0002543 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 DEATH, 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 TWA AND MAY HAVE BEEN AS HIGH AS 2,000" TWA.A,000 ppm There is some controversy RSV 0002544 -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 PPM; ANOTHER USES AN APPROXIMATE 4,000 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 THE 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 PATS 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 Bio-Test mice appear to be much MORE SENSITIVE THAN MALTONI'S SpRAGUE- RSV 0002545 8- - Dawley rats, although it should be recog nized THAT EXPOSURE CONDITIONS IN THE TWO CASES WERE SOMEWHAT DIFFERENT. 4. E 13ven if it is assumed that the 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 VETERAN WORKERS EMPLOYED WHO HELD THEIR JOBS DURING THE 1940'S, 1S50'S AND EARLY 1960's. RSV 0002546 -9 - In this connection, it was also pointed out during our sessions that the new attention being focused on angio sarcoma of THE LIVER, EER E, 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 PLACE GREAT RELIANCE ON THE 25 CASES PER YEAR FIGURE FOR THE GENERAL POPULATION 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 RSV 0002547 10 POPULATION WITH ITS OCCURENCE AMONG WORKERS IN THE VINYL CHLORIDE AND POLYVINYL CHLORIDE PRODUCING INDUSTRIES. RSV 0002548