Document pB3bJ29Q4Mxz12gLjaB80L6ND

APPL1E! EPIDEMIOLOG\ INC. February 27,1998 Ms. Wendy K. Sherman Manager, Vinyl Chloride Health Committee Chemical Manufacturers Association 1300 Wilson Blvd. Arlington, VA 22209 Dear Ms. Sherman: Enclosed please find our "baseline" results for the CMA Vinyl Chloride Study cohort. Specifically, these results reflect our re-calculation of all causes ofdeath reported by Dr. Wong through 1982, as well as several additional causes of death not previously analyzed or reported (due to limitations of the available analytical packages ofthe time) and with at least two observed or two expected deaths. Our cohort differs from that analyzed by Dr. Wong in that we have identified and corrected numerous errors, restored several hundred cohort members not included in Dr. Wong's analyses and discovered some additional deaths. The details of these differences have been presented in earlier progress reports, and the final description will be detailed in our final report to CMA. Three columns of results are presented in the accompanying table: the first column contains results based on our cleaned and expanded cohort using the United States mortality rates as the reference (methodologically most comparable to Dr. Wong's results); the second set contains results using rates for the states in which each plant was/is located; and the third reflects Dr. Wong's results. Almost universally, our results minor those of Dr. Wong. Most exceptions are due to some re arrangement of specific causes of death within broader disease categories, often reflecting the way deaths are coded over different time periods and in different states (e.g., liver cancers and cardiovascular disease deaths). The one result which might be considered a "new" finding is the elevated SMR for "connective and soft tissue" cancers (three-fourths of the way down on page two), with SMR=381 using the United States reference rates (95% confidence interval 153 to 785) and SMR=367 using state referent rates (95% confidence interval 147 to 755), based on seven observed deaths due to these cancers. (continued) UCC 109072 P.O. BOX 2424 AMHERST, MA 01004 W (413) 256-3556 FAX (413) 256-3503 (Ms. Sherman, page 2) Biologically, this observed excess might be related to the well-known association between vinyl chloride exposure and angiosarcoma of the liver, as angiosarcomas (tumors of the blood vessels) occurring outside of the liver are classified as soft tissue sarcomas. On the other hand, Heaths due to angiosarcoma of the liver but erroneously recorded on a death certificate simply as "angiosarcoma" without specifying "ofthe liver" will be classified as a soft tissue sarcoma as well. Unfortunately, it is not possible to determine from the death certificate whether this has occurred. Nevertheless, this association has not been reported elsewhere to date; therefore, we believe that you may have some obligation to report this finding to EPA under the Toxic Substances Control Act. Please feel free to call if you have any questions about these baseline results. Thank you. Sincerely yours, Kenneth A. Mundt, Ph.D. enclosure UCC 109073 Applied Epidemiology, Inc. baseline study results and Wong et al., 1992 results: Observed (Obs) and expected (Exp) deaths, standardized mortality ratios (SMR's) and ninety-five percent confidence intervals (95% Cl's) using U.S. white male mortality rates, plant state-specific white male mortality rates, for follow-up through December 31,1982 Cause of death All causes Obs 1569 Applied Epidemiology, Inc. baseline analysis U.S. reference rates Stale reference rates I R Exp 1734.92 SMR 90 95% Cl 86-95 Exp SMR 1876.87 84 95% Cl | Obs 80-88 1536 Wong et al., 1992 U.S. reference rates Exp 1705.27 SMR 90 95% Cl 86-95 All malignant neoplasms Cancer of: Buccal cavity A pharynx Tongue Other parts buccal cavity Pharynx Digestive organs & peritoneum Esophagus Stomach Intestine, except rectum Rectum Liver & biliary tract Pancreas 389 363.09 107 97-118 380.46 102 92-113 359 341.73 105 94-17 13 11.81 no 59-188 11.61 112 60-192 12 11.55 104 54-181 4 2.74 146 40-374 2.56 156 43-400 4 nr - 3 3.15 95 20-278 2.98 101 21-294 3 nr -- 5 5.66 88 29-206 5.79 86 28-202 4 nr - 106 94.82 112 92-135 91.43 116 95-140 99 89.21 Ill 90-135 7 8.59 81 33-168 8.37 84 34-172 7 8.07 87 35-179 II 16.10 68 34-122 14.78 74 37-133 10 16.01 63 30-115 21 31.44 67 41-102 29.57 71 44-109 20 28.79 70 42-107 5 9.71 51 17-120 8.89 56 18-131 5 9.91 50 16-118 39 8.11 481 342-657 9.11 428 304-585 37 5.77 641 450-884 18 19.21 94 55-148 18 89 95 56-151 16 18.40 87 50-141 UCC 109074 Page I of6 Applied Epidemiology, Inc. baseline analysts U.S. reference rates Stale reference rates Wongetal., 1992 U.S. reference rates Cause or death Peritoneum St other digestive organs Obs Exp SMR 95V* Cl Exp SMR 95% Cl Obs Exp SMR 95% Cl 5 1.65 302 98-706 1.82 274 89-640 4 nr _ Respiratory system 128 132.71 96 80-115 151.35 85 71-101 115 122.25 94 78-113 Larynx Trachea, bronchus Sc. lung Other respiratory system Prostate Kidney Bladder Skin Eye 3 5.44 55 11-161 5.94 50 10-148 3 5.24 57 12-168 122 125.56 97 81-116 143.58 85 71-101 111 115.87 96 79-116 3 1.71 176 36-513 1.83 164 34-480 1 nr - IS 16.55 91 51-149 15.59 96 54-159 15 15.20 99 55-163 II 9.53 115 58-207 9.73 113 56-202 11 9.06 121 61-217 6 8.58 70 26-152 8.34 72 26-157 5 8.46 59 19-138 7 8.28 85 34-174 8.34 83 33-171 6 7.36 82 30-178 2 0.32 628 76-2269 0.42 475 58-1717 0 0.31 0 Brain Sl other nervous system 22 1361 162 101-245 13.05 169 106-255 23 12.76 180 114-271 Thyroid 2 0.74 269 33-972 0.73 274 33-989 2 0.68 293 36-1059 Bone 2 1.66 120 15-434 2.19 91 11-330 2 1.81 111 13-399 Connective Sc. soft tissue 7 1.84 381 153-785 1.91 367 147-755 6 nr - Lymphatic St hematopoietic 37 36.91 100 71-138 37.29 99 70-137 37 36.28 102 72-141 Lymphosarcoma/reliculosarcmna 10 7.77 129 62-237 7.72 130 62-238 II 7.98 138 69-247 Hodgkin's disease 3 5.16 58 12-170 5.31 57 12-165 3 5.45 55 11-161 Leukemia & aleukemia 12 14.73 81 42-142 15.03 80 41-139 13 13.94 93 50-159 UCC 109075 Page 2 of6 Cause or death Other lymphatic ft hematopoietic Unspecified Benign ft unspecified nature neoplasms Unspecified nature of eye, brain ft other nervous system Other Obs 12 29 7 4 3 Applied Epidemiology, Inc. baseline analysis U.S. reference rales Stale reference rates Exp SMR 95% Cl Exp SMR 95% Cl 9.25 130 67-227 9.23 130 67-227 22.37 130 87-186 25.13 115 77-166 5.70 123 49-253 5.54 126 51-260 Obs 10 23 4 2.68 149 41-382 2.80 143 39-365 1 2.07 145 30-424 2.01 149 31-436 3 Wong et a!., 1992 U.S. reference rates Exp SMR 95% Cl 8.37 119 57-220 nr 5.08 79 21-201 nr - nr - Diabetes mellitus 23 23.89 96 61-144 25.38 91 57-136 22 23.52 94 59-142 Diseases of the blood ft blood forming 2 4.17 48 6-173 4.37 46 6-165 2 3.76 53 6-192 organs Mental, psychoneurotic ft personality disorders Alcoholism Other mental disorders 7 12.74 55 22-113 13.15 53 21-110 4 11.80 34 9-87 4 8.86 45 12-116 9.20 43 12-111 3 nr - 3 3.87 77 16-226 3.94 76 16-222 1 nr UCC 109076 Page 3 of6 Cause of death Diseases of the nervous system & sense organs Multiple sclerosis Other diseases of nervous system A sense organs Ohs 14 3 II Applied Epidemiology, Inc. baseline analysis H U.S. reference rates State reference rates I Exp SMR 95% Cl Exp SMR 95% Cl Obs 17.29 81 44-136 17.40 80 44-135 15 Wong et al., 1992 U.S. reference rates Exp SMR 95% Cl nr - 2.31 130 27-380 1.87 161 33-470 3 nr -- 14.98 73 37-131 15.53 71 35-127 12 nr Diseases of the heart Rheumatic heart disease Ischemic heart disease Chronic disease of endocardium Other myocardial degeneration Hypertension with heart disease Other heart diseases 642 680.17 94 87-102 735.95 87 81-94 601 nr -- 12 18.71 64 33-112 16.46 73 38-127 14 19.33 72 40-122 535 583.71 92 84-100 630.80 85 78-92 488 597.73 82 75-89 5 3.55 141 46-329 3.17 158 51-368 3 nr - 3 7.89 38 8-111 5.84 51 11-150 31 nr - 23 15.20 151 96-227 14.50 159 101-238 23 nr -- 64 51.12 125 96-160 65.17 98 76-125 42 nr - UCC 109077 Other diseases of the circulatory system 109 129.73 84 69-101 143.51 76 62-92 103 nr ~ Hypertension without heart disease 3 4.53 66 14-193 5.06 59 12-173 8 nr -- Cerebrovascular disease 78 86.64 90 71-112 96.46 81 64-101 70 91.93 76 60-96 Diseases of arteries, veins & pulmonary circulation 28 38.55 73 48-105 41.99 67 44-96 nr -- Page 4 of6 Cause ofdeath Diseases of the respiratory system Pneumonia Chronic Sc unspecified bronchitis Emphysema* Asthma Pneumoconioses Sc other respiratory diseases (includes COPD) Emphysema & COPD* Diseases of the digestive system Diseases of stomach Sc duodenum Hernia Sc intestinal obstruction Cirrhosis of the liver Other digestive system diseases Obs 70 16 2 17 1 33 63 9 2 38 14 Applied Epidemiology, Inc. baseline analysis Wongetal., 1992 U.S. reference rales State reference rates U.S. reference rates Exp SMR 95% Cl Exp SMR 95% Cl Obs Exp SMR 95% Cl 91.93 76 59-96 111.60 63 49-79 70 87.61 80 62-101 31.54 51 29-82 34.41 47 27-76 15 31.94 47 26-78 4.38 46 6-165 5.44 37 4-133 2 nr - 20.12 84 49-135 23.45 72 42-116 17 nr - 3.00 33 1-185 3.76 27 1-148 1 2.89 35 1-192 30.30 109 75-153 41.21 80 55-112 35 nr " 41 22.83 ISO 129-244 97.55 65 50-83 93.36 67 52-86 60 95.58 63 48-81 12.11 74 34-141 12.02 75 34-142 8 11.15 72 31-414 3.81 53 6-190 3.83 52 6-189 2 nr -- 56.70 67 47-92 50.91 75 53-102 35 56.06 62 43-87 24.93 56 31-94 26.60 53 29-88 14 nr -- Diseases of the genitourinary system Chronic/unspecified nephritis Other genitourinary diseases 8 4 3 19.80 40 17-80 21.55 37 16-73 9 9.41 43 12-109 10.11 40 11-101 4 3.77 79 16-232 4.33 69 14-203 20.41 44 20-84 8.29 48 13-123 nr UCC 109078 Page So/6 Applied Epidemiology, Inc. baseline analysis U.S. reference rales Slate reference rates I I Wong el al., 1992 U.S. reference rates Cause of death Obs Exp SMR 95% Cl Exp SMR 95% Cl Obs Exp SMR 95% Cl Diseases of musculoskeletal system ft 1 3.13 32 1-177 3.28 30 1-170 connective tissue -- Symptoms ft ill-defined conditions 7 21.31 33 13-67 26.68 26 11-54 10 21.79 46 22-84 All external causes Accidents Violence Suicide Homicide Other causes 183 226.58 81 69-93 236.67 71 61-82 168 225.97 74 64-87 117 153.26 76 63-91 175.92 67 55-80 108 150.16 72 59-87 66 73.32 90 70-114 81.75 81 62-103 60 nr - 49 53.89 91 67-120 55.51 88 65-117 46 52.78 87 64-116 17 19.43 87 51-140 26.24 65 38-104 14 nr - 13 25.00 60 34-99 25.49 59 33-97 ? nr ~ Unknown 28 97 nr=no rates available for category of death * In the NIOSH categories of death (used in AEI baseline analysis), deaths from emphysema (ICD-7 327.1; ICD8 492; ICD9 492) are included in Emphysema and deaths from COPD (ICD-7 327.2; ICD-8 319.2; ICD-9 496) are included in Pneumoconioses A other respiratory diseases. In the Monson categories of death (used in Wong el al. analysis), Emphysema & COPD includes deaths from any of the following: Pulmonary collapse (ICD-7 327.0); Emphysema without mention of bronchitis (ICD-7 327.1); Other diseases of the lung (includes COPD) (ICD-7 327.2). UCC 109079 Page 6 of6