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* , u*r>.'SAHT9W|yj| TESTIMONY ON THE PROPOSED STANDARD FOP. VINYL CHLO^.IDF PRESENTED BY THE DOW CHEMICAL COMPANY JUNE 25, 1974 rmiMritii'rfMi-'fiTl M R&S 132814 -' ? -if 1 " * *W*jj ; ~y 4,? < 5 jT^<iKS^wr/k'> -*f%' J? jf . tV . . ' 'J , lilt - ;^.r^ P iV- -..' ^ :??\ ^'TESTIMONY ~Ofl THE^ ^ :,v5; -^ajfrsci'v' ,' -<'-*- . \ ;_ ' -."- - .-- ,, '- * Xr'j-1'JS.- ` ` "' - > r .v- ' i,,--=4>--;-r^ii^N f ^^fjWKfc-t. - Tjj '\y.-`? .' * ~! ' ' * .*$weB cn -;?&**... *&+v:.,.J: ''""V?5 'V , !-* ,|.liV^|K; 'rv.< Si. f-. piSKJTJl f^rj. '&ii '- *,*. V. rf^-.^Vv-- ' :T vtion i mm. &&s INTRODUCTION V. K. Rowe The Dow Chemical Company Midland/ Michigan INTRODUCTION I V. K.am Rowe,, Director of Toxicological Affairs in Health and Environmental Research for Dow Chemical U.S.A. I i RECEIVED a BATCHELORS DEGREE WITH MAJORS IN CHEMISTRY AND BIOLOGY IN 1936,, A MASTERS OF SCIENCE DEGREE WITH A MAJOR IN BIOCHEMISTRY FROM THE STATE UNIVERSITY OF IOWA 1937in and an Honorary Doctor of Science degree from 1971.Cornell College in R&S 132818 2- - I joined the Biochemical Research Laboratory of The Dow 1937Chemical Company in the fall of and have remained WITH THE COMPANY THROUGHOUT MY CAREER. I 1973,n the fall of I was named a Research Scientist AND GIVEN MY PRESENT JOB TITLE. I am a Charter Member of the Society of Toxicology, and SERVED AS ITS PRESIDENT DURING THE YEAR 1966-67. I AM CERTIFIED BY THE AMERICAN BOARD OF INDUSTRIAL HYGIENE IN the Toxicological Aspects of Industrial Hygiene and served as President of the American Academy of Industrial Hygiene I 70THIS PAST YEAR. HAVE AUTHORED OR COAUTHORED OVER SCIENTIFIC PUBLICATIONS AND FIVE CHAPTERS OF A TEXT BOOK ON INDUSTRIAL TOXICOLOGY. R&S 132819 -3I HAVE BEEN ACTIVE THROUGHOUT MY ENTIRE CAREER IN THE AREA OF INDUSTRIAL TOXICOLOGY, INDUSTRIAL HYGIENE AND SAFETY EVALUATION. Throughout these years I have seen dramatic changes in THE DEGREE OF COMPREHENSIVENESS WITH WHICH TOXICOLOGICAL INDUSTRIAL HYGIENE AND MEDICAL SURVEILLANCE STUDIES HAVE BEEN AND ARE BEING CONDUCTED. THE TECHNOLOGIES USED IN THE 1930'S AND 1940'S WERE CRUDE WITH RESPECT TO THOSE USED IN THE 1950'S AND EARLY 1960's BUT IT MUST BE REMEMBERED THAT THEY WERE THE BEST AVAILABLE AT THE TIME. Likewise, those used in the late 1960's and now, are more COMPREHENSIVE THAN THOSE OF TEN YEARS AGO. I WILL BE AMAZED IF IN 1980 THE SAME CANNOT BE SAID OF THE TECHNOLOGY IN USE TODAY. THE SAME COMPARISONS APPLY TO ENGINEERING CAPABILITIES AND PRACTICES; PRODUCTION PLANTS AND PROCESSING PROCEDURES ENGINEERED TODAY BEAR R&S 132820 R&S 132821 -4ONLY A RESEMBLANCE TO THOSE ENGINEERED AND BUILT AS LITTLE AS A DECADE AGO. WHY AM I TAKING THE TIME TO MAKE THIS POINT? I WANT TO EMPHASIZE THAT THESE CHANGES REPRESENT PROGRESS MADE THROUGH RESEARCH AND I BELIEVE THAT THE VINYL CHLORIDE PROBLEM WE HAVE TODAY WILL BE SOLVED BY RESEARCH, NEW DISCOVERY AND THE APPLICATION OF the Rule of Reason. Up until very recently when the toxicologists AND ONCOLOGISTS BEGAN TO ATTACH MUCH GREATER SIGNIFICANCE TO THE OVERALL CANCER PROBLEM, TYPICAL INHALATION TOXICOLOGY STUDIES, WHETHER DONE BY GOVERNMENT, INDUSTRY, OR ACADEMIA, CONSISTED OF EXPOSING RELATIVELY SMALL GROUPS OF ANIMALS FOUR TO SEVEN HOURS/DAY, 5 DAYS/WEEK FOR A FEW WEEKS, OR AT MOST, FOR A FEW MONTHS, The purpose was to find the maximum CONCENTRATION THAT DID NOT CAUSE A DISCERNIBLE EFFECT AND R&S 132822 -5TO CHARACTERIZE THE EFFECT AT HIGHER LEVELS. SUCH DATA, WHEN AVAILABLE,, WERE USED IN THE GUIDELINES FOR PERMISSIBLE INDUSTRIAL EXPOSURE. It WAS TO SUCH A TESTING PROGRAM THAT' WE SUBJECTED VINYL CHLORIDE IN 1960, THE RESULTS OF WHICH WERE PUBLISHED IN 1961. Even though these studies on vinyl chloride were of longer DURATION THAN ANY OTHERS, THEY WERE STILL OF TOO SHORT A DURATION TO PERMIT DETECTION OF CARCINOGENICITY. THEY DID, HOWEVER, GIVE US A USEFUL INDICATION OF SIMPLE TOXICITY WHICH HELPED TO CAUSE US TO EXERT A POSITIVE EFFORT TOWARD REDUCING THE INTENSITY OF EXPOSURE WITHIN OUR OPERATING UNITS. R&S 132823 6- - I MAKE THIS POINT BECAUSE I HEAR COMMENTS TO THE EFFECT THAT THE DEFINITIVE STUDIES SUCH AS PROF. MALTONI AND MCATHE ARE CONDUCTING NOW SHOULD HAVE BEEN CONDUCTED YEARS AGO, It IS TRUE THAT IT WOULD HAVE BEEN GREAT IF SOMEONE HAD CONDUCTED SUCH STUDIES YEARS AGO, BUT NO ONE, TO MY KNOWLEDGE, EVEN SUSPECTED VINYL CHLORIDE OF BEING A CARCINOGEN, HENCE, IT WOULD HAVE BEEN DIFFICULT TO JUSTIFY THE USE OF THE LIMITED RESOURCES AVAILABLE FOR SUCH STUDIES FOR VINYL CHLORIDE. Furthermore, I doubt that Prof, Maltoni's studies WOULD HAVE BEEN INITIATED WHEN THEY WERE IF IT HAD NOT BEEN FOR THE SERENDIPITOUS DISCOVERY BY PROF. VlOLA OF TUMORS IN THE RATS IN WHICH HE WAS ATTEMPTING TO INDUCE THE LIKENESS OF HUMAN ACROOSTEOLYSIS. 7- - I DO FEEL, HOWEVER, THAT THE VINYL CHLORIDE PROBLEM HAS TAUGHT US ALL A LESSON THAT WILL, IN THE LONG RUN, DO MUCH TO DEVELOP AN AWARENESS THAT WILL LEAD TO BETTER OCCUPATIONAL AND ENVIRONMENTAL HEALTH. I FEEL THAT IT IS EASY TO OVERREACT TO SITUATIONS SUCH AS THE VINYL CHLORIDE PROBLEM AND MUCH MORE DIFFICULT TO STEP BACK, OBJECTIVELY ASSESS THE SITUATION AND DEVELOP A COURSE OF ACTION THAT TAKES INTO CONSIDERATION THE REASONABLY m EXPECTED CONSEQUENCES OF THAT ACTION. I BELIEVE THAT the Emergency Temporary Standard was a good example of THE LATTER TYPE OF ACTION FOR IT FOLLOWED THE RULE OF Reason, r &S 132824 8- - I FEEL THAT THE DEPT. OF LABOR SHOULD BE COMPLIMENTED ON THE SPEED AND FORCEFULNESS OF THE ACTION IT TOOK. Today,, with additional data in hand, the Dept, of Labor MUST REEVALUATE ITS POSITION. It IS OUR PURPOSE HERE TODAY TO SUPPLY THE INFORMATION AND THOUGHTS WE HAVE THAT MAY HELP THE DEPT. OF LABOR IN ITS DELIBERATIONS WITH RESPECT TO THE DEVELOPMENT OF A PERMANENT STANDARD for Occupational Exposure to vinyl chloride. The Dow Chemical Company, from top management down, is DEEPLY CONCERNED ABOUT THE HAZARDS TO HEALTH PRESENTED BY EXPOSURE TO VINYL CHLORIDE, AS WELL AS OTHER SUBSTANCES. DOW HAS BEEN IN THE FOREFRONT IN ITS CONCERNS ABOUT THE TOXICOLOGICAL HAZARDS PRESENTED BY THE MATERIALS IT USES, MANUFACTURES AND SELLS, R&S 132825 -9- This is attested to by the fact that Dow supports TOXICOLOGICAL RESEARCH LABORATORIES IN MIDLAND, MICHIGAN, Freeport, Texas and zionsville, Indiana employing a total of 126 persons, 25 of whom have doctorate degrees. Its industrial hygiene laboratories are staffed with over TWENTY INDUSTRIAL HYGIENISTS SUPPORTED BY A NUMBER OF ANALYTICAL SPECIALISTS. ITS MEDICAL FACILITIES AT Midland, Michigan and Freeport, Texas are extensive; THE STAFFS CONSIST OF BETWEEN 70 AND 85 PERSONS, H THEOF WHOM ARE FULLTIME PHYSICIANS. SMALLER PLANTS ARE ALL SERVED BY PART-TIME PHYSICIANS AND FULLTIME STAFFS UNDER THE SUPERVISION OF THE PHYSICIANS OF OUR CORPORATE MEDICAL DEPARTMENT. 3J #> </> 132826 R & S 132827 -10- It is from this cadre of expertise that our subsequent TESTIMONY WILL BE DRAWN, We HOPE IT WILL BE HELPFUL TO THOSE CHARGED WITH THE RESPONSIBILITY OF WEIGHING RISK VERSUS BENEFIT WITHIN THE CONCEPT OF THE RULE OF Reason. We WILL PRESENT TESTIMONY DEALING WITH ENGINEERING PRACTICES/ INDUSTRIAL HYGIENE MEASUREMENTS/ PERSONAL PROTECTIVE DEVICES/ MEDICAL SURVEILLANCE/ MEDICAL OBSERVATION BASED ON A STUDY OF MORTALITY AND A PROGRESS REPORT ON RESEARCH INTO THE POSSIBLE MECHANISM OF ACTION OF VINYL CHLORIDE. It IS OUR PLAN TO HAVE THOSE MOST FAMILIAR WITH THE VARIOUS ASPECTS TO MAKE THESE PRESENTATIONS, 11- - M .NOW, I SHOULD LIKE TO INTRODUCE r KARL OELFKE, PRODUCTION Manager of vinyl chloride who will discuss our experiences RELATIVE TO THE RELATIONSHIP BETWEEN ENGINEERING, WORK PRACTICE AND MONITORING IN THE REDUCTION OF THE RELEASE OF VINYL CHLORIDE AND CONCOMITANTLY THE REDUCTION IN THE OPPORTUNITY FOR EXPOSURE OF PERSONS TO THE VAPOR. 37 Co CO