Document ZBOgb6B4a13X9B3L7JNpjRNaL

MONSANTO From (Name-Location-Phone) William R. Gaffey, A3NK, 4-8811 Date November 30, 1988 CC: Subject Reference Pathology Review of Vinyl Chloride Deaths TO B.R. Friedlander In 1986, Environmental Health Associates completed, for CMA, an update of an earlier cohort mortality study of workers employed in the manufacture and polymerization of vinyl chloride. Although Monsanto has not made vinyl chloride or PVC for several decades, we participated in both the original study and the update because we had a small population of workers who had been exposed in the past. The update showed an excess of liver and biliary cancer deaths over and above those stated on the death certificate to have been angiosarcoma, and the question has arisen as to whether that excess can be accounted for by angiosarcoma deaths that were not so stated on the death certificate. CMA asked the contractor, EHA, to get pathology data on the liver and biliary cancer deaths, but they were not successful. The CMA vinyl chloride panel decided that rather than abandoning the effort and leaving the possibility that vinyl chloride caused liver cancer other than angiosarcoma, they might be more successful going through the original participating companies. Therefore you will shortly receive a request from CMA to agree to chase down and obtain slides, where they exist, for the Monsanto liver and biliary cancer deaths that occurred in the study. Our Indian Orchard plant participated, and I estimate that there would be at the most about five such deaths.I I recommend that we agree to cooperate. I don't know whether we can find pathology data for our deaths or not, but we would be vulnerable if we didn't agree to try. william R. Gaffey /j j RSV 0007261 OBSERVED CANCER DEATHS AND SMRs BY NUMBER OF YEARS SINCE FIRST EXPOSURE TO VINYL CHLORIDE1 YEARS SINCE FIRST EXPOSURE < 20 YRS OBS SMR 20-30 YRS OBS SMR 30 + YRS OBS SMR ALL CANCERS BUCCAL CAVITY ESOPHAGUS STOMACH LGE. INTESTINE LIVER & BILIARY TRACT RESPIRATORY 130 93.2 133 6 126.5 2 66.5 A 54.7 8 72,7 10 385.7** 4 2 4 3 11 45 100.0 47 113.4 95.8 67.3 77.9 30.2* 590.1** 104.1 96 113.0 2 75.9 3 143.5 2 56.1 9 114.5 16 1213.3' 25 71.6 1ADAPTED FROM "AN UPDATE OF AN EPIDEMIOLOGIC STUDY OF VINYL CHLORIDE WORKERS, 1942-1982" BY EHA, INC. SIGNIFICANT AT 5l LEVEL SIGNIFICANT AT 1% LEVEL RSV 007262 LTV CRITERIA FOR INFERRING CARCINOGENICITY FROM EPIDEMIOLOGIC STUDIES 1. THERE MUST BE A STATISTICALLY SIGNIFICANT EXCESS OF CANCER IN THE EXPOSED GROUP COMPARED WITH A SIMILAR UNEXPOSED GROUP. 2. THE EXCESS MUST NOT BE EXPLAINABLE BY CONFOUNDING FACTORS. 3. THE EXCESS MUST VARY APPROPRIATELY WITH THE CIRCUMSTANCES OF EXPOSURE. A. THE RESULTS MUST BE FOUND IN SEVERAL INDEPENDENT STUDIES. . THERE MUST BE APPLAUSIBLE BIOLOGICAL MECHANISM. RSV 0007263 MORTALITY FROM SELECTED CANCERS BY NUMBER OF YEARS FROM FIRST EXPOSURE, ACRYLONITRILE WORKERS1 1 CANCERS STOMACH COLON LUNG BRAIN YEARS FROM FIRST EXPOSURE 1-9 OBS SMR 8 121 2 236 10-15 OBS SMR 8 133 1 167 16 + OBS SMR 5 S5 2 333 TOTAL OBS SMR 21 114 5 263 1 250 1 250 0 0 2 167 3 120 00 4 160 1 500 2 SO 1 1000 9 120 2 3.33 Adapted from werner, j.b, and carter, j.t. "mortality of UNITED KINGDOM ACRYLONITRILE POLYMERIZATION WORKERS" BR, J. IND. MED. 38:247-253, 1931 fcSV 000726*