Document KeVDLz8rJ1QEL6agL2Y8BBn6

Chemical Manufacturers Association Courtney m. Price Vice President CHEMSTAR March 18,1998 Via Certified Mail Document Processing Center Mail Code 7407 Room E-G99 East Tower Office of Pollution Prevention and Toxics Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 Attention: TSCA 8(e) Coordinator Dear Sir: The Vinyl Chloride Health Committee of the Chemical Manufacturers Association submits the enclosed preliminary results from an ongoing update of an epidemiology study of vinyl chloride workers last followed up by Wong et al, Am. J. Ind. Med. (1991) 20(3): 317-34. These results are submitted pursuant to Section 8(e) of the Toxic Substances Control Act. The enclosed tables represent the study contractor's baseline results compared to the results reported by Wong et al. According to the contractor, the current cohort differs from that analyzed by Wong et al. in that numerous errors are identified and corrected, several hundred cohort members not included in Wong et al.'s analyses have been restored, and some additional deaths have been discovered. Three columns of results are presented in each table; the first column contains results based on the cleaned and expanded cohort using U.S. mortality rates as the reference (methodologically most comparable to Wong et al.'s results); the second contains results using rates for the states in which each plant was/is located; and the third reflects Wong et al's results. Almost universally, the update results mirror those of Wong et al. Most exceptions are due to some rearrangement 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). CMA 171045 Innovation, Technology and Responsible Care At Work L1-3--0-0--W---il-s-o--n--B-l-v-d--.,--A-r--l-in-g--t-o-n--, -V--A--2-2--2-0--9----T--e-l-e-p-h-o-n-e--7--0-3-*-7-4--1---5--6-0-0-----F-a-x--7-0--3---7-4--1---6-0--9-1LSg IfRAesPpuoblnicsCibulnemCxaliriew*it 2- - The standardized mortality ratio (SMR) for "connective and soft tissue" cancers is significantly elevated (SMR=381 using the U.S. reference rates (95% confidence interval (Cl) 153 to 785) and SMR-367 using state reference rates (95% Cl 147 to 755)), based on seven observed deaths due to these cancers. Although the number of deaths due to "connective and soft tissue" cancers identified through 1982 by both Wong et al. and by AEI was similar (six and seven deaths, respectively), Wong et al. did not have available the analytical tools to calculate an SMR for this category. This information has not been reported elsewhere to date. Biologically, the 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, deaths due to angiosarcoma of the liver but erroneously recorded on a death certificate simply as "angiosarcoma" without specifying "of the 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. The SMR for cancers of the "peritoneum and other digestive organs" is also significantly elevated (SMR=302 using U.S. reference rates (95% Cl 98 to 706) and SMR=274 (95% Cl 89 to 640)), based on five observed deaths due to these cancers. The study contractor has indicated that these five observed cancers were broadly distributed by specific cancer site and likely have different etiologies. In light of the absence of consistency of these cancers, the contractor advises that this observation is unlikely to have any biological significance. This submission is made on behalf of the members of the CMA Vinyl Chloride Health Committee. The members of the Committee are: Borden Chemicals and Plastics 180 E. Broad Street, 15th FI. Columbus, OH 43215 Panel Contact: Mr. Mark Gruenwald Telephone: (614)225-3459 CONDEA Vista Company 900 Threadneedle P.O. Box 19029 Houston, TX 77079 Panel Contact: Dr. David A. Penney Telephone: (281) 588-3059 CMA 171046 The Dow Chemical Company 1803 Dow Center Midland, MI 48674 Panel Contact: Dr. Colin Park, Telephone: (517)636-1159 Formosa Plastics 9 Peachtree Hill Rd. Livingston, NJ 07039 Panel Contact: Mr. David Pun Telephone: (973) 716- 7279 The GEON Company One Geon Center Avon Lake, OH 44012 Panel Contact: Mr. Ed Beeler Telephone: (440)930-3030 Georgia Gulf Corporation 26100 Highway 405 P.O. Box 629 Plaquemine, LA 10165 Panel Contact Mr. Jay Strange Telephone: (504) 685-2642 Occidental Chemical Corp. 5005 Lyndon B. Johnson Freeway, Room 904 Dallas, TX 75244 Panel Contact: Dr. Steve Phillips Telephone: (972)404-2413 Westlake Chemical Corp. 2801 Post Oak Blvd. Suite 600 Houston, TX 77056 Panel Contact: Mr. John Gamble Telephone: (713) 960-9111 PPG Industries, Inc. One PPG Place Pittsburgh, PA 15272 Panel Contact: Dr. James A. Barter Telephone: (412)434-2801 If you have any questions regarding this letter, please contact Wendy Sherman of my staff at (703) 741-5639. Sincerely, r Courtney M. Price Vice President, CHEMSTAR Enclosure cc: Vinyl Chloride Health Committee CMA 171047 CM A 171048 Applied Epidemiology, Inc. baseline study results and Wong et at., 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 Applied Epidemiology, Inc. baseline analysis U.S. reference rates State reference rates Obs Exp SMR 95% Cl Exp SMR 95% Cl 1569 1734.92 90 86-95 1876.87 84 80-88 Obs 1536 Wong et a!., 1992 U.S. reference rates Exp SMR 95% Cl 1705.27 90 86-95 All malignant neoplasms Cancer of; Buccal cavity & 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 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 18 19.21 94 55-148 18.89 95 56-151 16 18.40 87 50-141 Page 1 of6 C M A 171049 Applied Epidemiology, Inc. baseline analysis Wong et al, IW2 U.S. reference rates State reference rates U S reference rates Cause of death Obs Exp SMR 95% C! Exp SMR 95% Cl Obs Exp SMR 95% Cl Peritoneum & other digestive organs Respiratory system 5 1.65 302 98-706 1.82 274 89-640 4 nr 128 132.71 96 80-115 151.35 85 71-101 115 122.25 94 78-113 Larynx 3 5.44 55 11-161 5.94 50 10-148 3 5.24 57 12-168 Trachea, bronchus & lung 122 125.56 97 81-116 143.58 85 71-101 111 115.87 96 79-116 Other respiratory system 3 1.71 176 36-513 1.83 164 34-480 1 nr - Prostate 15 16.55 91 51-149 15.59 96 54-159 15 15.20 99 55-163 Kidney li 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 7 8.28 85 34-174 8.34 83 33-171 6 7.36 82 30-178 Eye 2 0.32 628 76-2269 0.42 475 58-1717 0 0.31 0 Brain & other nervous system 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 1.81 111 13-399 Connective & soft tissue 7 1.84 381 153-785 1.91 367 147-755 6 nr - Lymphatic & 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 & aleukemia 12 14.73 81 42-142 15.03 80 41-139 13 13.94 93 50-159 Page 2 of6 *. C M A 171050 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 Wong et at., 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 9.25 130 67-227 9.23 130 67-227 10 8.37 119 57-220 22.37 130 87-186 25.13 115 77-166 23 nr - 5.70 123 49-253 5.54 126 51-260 4 5.08 79 21-201 2.68 149 41-382 2.80 143 39-365 1 nr "" 2.07 145 30-424 2.01 149 31-436 3 nr -- Diabetes mellitus 23 23.89 96 61-144 25.38 91 57-136 22 23.52 94 59-142 Diseases of the blood & blood forming 2 4.17 48 6-173 4.37 46 6-165 2 3.76 53 6-192 organs Mental, psychoneurotic & 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 Page 3 of6 C M A 171051 Cause of death Diseases of (he nervous system & sense organs Multiple sclerosis Other diseases of nervous system & sense organs Obs 14 3 11 Applied Epidemiology, Inc. baseline analysis Wong et a!., 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 17.29 81 44-136 17.40 80 44-135 15 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 -- Other diseases or 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 Diseases of arteries, veins & pulmonary circulation 78 86.64 90 71-112 96.46 81 64-101 70 91.93 76 28 38.55 73 48-105 41.99 67 44-96 25 nr - 60-96 Page 4 of6 C M A 171052 Cause of death Diseases of the respiratory system Pneumonia Chronic & unspecified bronchitis Emphysema* Asthma Pneumoconioses & other respiratory diseases (includes COPD) Emphysema & COPD* Diseases or 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 al., 1992 U.S. reference rates State reference rates U.S. reference rates Exp SMR 95% Cl Exp SMR 95% Cl Obs Exp SMR 95% C! 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 [-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 C M A 171053 Applied Epidemiology, Inc. baseline analysis Wong et al., 1992 U.S. reference rates State reference rates 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 & 1 3.15 32 1-177 3.28 30 1-170 connective tissue -- Symptoms & ill-defined conditions 7 21.51 33 13-67 26.68 26 l!-54 10 21.79 46 22-84 All external causes Accidents Violence Suicide Homicide Other causes 183 226.58 81 69-93 256.67 71 61-82 168 225.97 74 64-87 117 153.26 76 63-91 175.92 67 55-80 108 150.16 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 - 15 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-7 527.1; 1CD8 492; ICD9 492) are included in Emphysema and deaths from COPD (ICD-7 527.2; ICD-8 519.2; ICD-9 496) are included in Pneumoconioses & other respiratory diseases. In the Monson categories of death (used in Wong et al. analysis), Emphysema & 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). Page 6 of6