Document YrBJaJnoJjmmGE3z6wjZkmLOk

APPLIE! EPIDEMIOLOGY 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 of death 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 ofresults 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 mirror 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 ^ (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, rWhs 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 rales, for follow-up through December 31,1982 Cause of death All causes Applied Epidemiology, Inc. baseline analysis U.S. reference rates State reference rates Obs Exp SMR 95% Cl Exp SMR 95% Ci 1569 1734 92 90 86-95 1876.87 84 80-88 Wong et al., 1992 U.S. reference rates Obs Exp SMR 95% CI 1536 1705.27 90 86-95 1 All malignant neoplasms Cancer of: Buccal cavity A pharynx Tongue Other parts buccal cavity Pharynx Digestive organs A peritoneum Esophagus Stomach Intestine, except rectum Rectum Liver A biliary tract Pancreas 389 363.09 107 97-118 380.46 102 92-113 359 341.73 105 94-17 13 11.81 110 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 5.66 106 94.82 88 29-206 5.79 112 92-135 91.43 86 28-202 116 95-140 4 99 nr 89.21 * 111 90-135 7 8.59 81 33-168 8.37 84 34-172 7 8.07 87 35-179 11 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 ts 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 analysis I Wong et al., 1992 U.S. reference rales Slate reference rates I U.S. reference rales Cause of death Periloneum ft other digestive organs Obs Exp SMR 95% Cl Exp SMR 95% Cl 1 Obs Exp SMR 95% Cl 5 1.65 302 98-706 1.82 274 89-640 4 nr - Respiratory system Larynx Trachea, bronchus & lung 128 132.71 96 80-115 151.35 85 71-101 115 122.25 94 78-113 a 5.44 55 11-161 5.94 50 10-148 3 5.24 57 12-168 122 123.$6 97 81-116 143.58 85 71-101 III 115.87 96 79-116 Other respiratory system 3 1.71 176 36-513 1.83 164 34-480 1 nr - Prostate Kidney 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 Bladder 6 8.58 70 26-152 8.34 72 26-157 5 8.46 59 19-138 Skin Eye Brain ft other nervous system 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 22 13.61 162 101-245 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 III 13-399 Connective ft soft tissue 7 1.84 381 153-785 1.91 367 147-755 6 nr -- Lymphatic ft hematopoietic 37 36.91 100 71-138 37.29 99 70-137 37 36.28 102 72-141 Lymphosarcoma/reticulosarcoma 10 7.77 129 62-237 7.72 130 62-238 11 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 ft aleukemia 12 14.73 81 42-142 15.03 80 41-139 13 13.94 93 50-159 UCC 109075 Page 2 of6 1 Cause of death Other lymphatic & hematopoietic Unspecified Benign & unspecified nature neoplasms Unspecified nature of eye, brain & other nervous system Other Obs 12 29 7 4 3 Applied Epidemiology, Inc. baseline analysis U.S. reference rales Exp SMR 95% Cl 9.25 130 67-227 Stale reference rales IExp SMR 95% Cl Obs 9.23 130 67-227 10 22.37 130 87-186 25.13 115 77-166 1 23 I5.70 123 49-253 5.54 126 51-260 4 2.68 149 41-382 2.80 143 39-365 1 1 I2.07 145 30-424 2.01 149 31-436 3 Wong el 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 <fc blood forming organs 2 4.17 48 6-173 4.37 46 6-165 2 3.76 53 6-192 Mental, psychonenrotlc & 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 1 3 3 3.87 77 16-226 3.94 76 16-222 1 nr nr -- UCC 109076 Page 3 of6 Cause of death Diseases of the nervous system & sense organs Multiple sclerosis Other diseases of nervous system & sense organs Obs 14 3 II Applied Epidemiology, Inc. baseline analysis Wong et al., 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 17.29 81 44-136 17.40 80 44-135 IS 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 j 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 25 nr -- Page 4 of6 A Cause of death Diseases of (he respiratory system Pneumonia Chronic &. unspecified bronchitis Emphysema* Asthma Pneumoconioses 8c other respiratory diseases (includes COPD) Emphysema A COPD* Diseases of the digestive system Diseases of stomach & duodenum Hernia & 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 Wong et at., 1992 U.S. reference rates Stale reference rales 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 22.83 180 129-244 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 20.41 44 20-84 9.41 43 12-109 10.11 40 11-101 4 8.29 48 13-123 3.77 79 16-232 4.33 69 14-203 nr -- Page 5 of6 UCC 109078 Cause of death Diseases of musculoskeletal system A connective tissue Obs l Applied Epidemiology, Inc. baseline analysis Wongetal., 1992 U.S. reference rates State reference rates U.S. reference rates Exp SMR 95% Cl Exp SMR 95% Cl Obs Exp SMR 95% Cl 3.15 32 1-177 3.28 30 1-170 - Symptoms & ill-defined conditions 7 21.51 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 SI 69-93 256.67 71 61-82 168 225.97 74 64-87 117 153.26 76 63-91 175.92 67 55-80 108 150. j 6 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 - IS 25.00 60 34-99 25.49 59 33-97 ? nr - Unknown 28 [ 97 nr=no rales available for category ofdeath * In the NIOSH categories of death (used in AEI baseline analysis), deaths from emphysema (ICD-7 527.1; ICD8 492; ICD9 492) are included in Emphysema and deaths from COPD (ICD-7 S27.2; ICD-8 519.2; 1CD-9 496) are included in Pneumoconioses A other respiratory diseases. In the Monson categories of death (used in Wong et al. analysis), Emphysema A COPD includes deaths from any of the following: Pulmonary collapse (ICD-7 527.0); Emphysema without mention of bronchitis (ICD-7 527.1); Other diseases of the lung (includes COPD) (ICD-7 527.2). UCC 109079 Page 6 of6