Document mG4OjJaoqE3a1VpNkRzB5d0Q
APPLIEI 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 ofdeath 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 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)
P.O.BOX 2424 AMHERST, MA 01004 W (413) 256-3556 FAX (413) 256-3503
CMA 171102
(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, deaths 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
CMA 171103
4
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
State reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl
1734.92 90
86-95 1876.87 84
80-88
Obs 1536
Wonget al., 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
110 59-188
11.61
112 60-192
12
4 2.74 146 40-374 2.56 156 43-400 4
3 3.15 95 20-278 2.98 101 21-294 3
5
5.66
88 29-206
5.79
86 28-202
4
106 94.82
112 92-135 91.43
116 95-140
99
7 8.59 81 33-168 8.37 84 34-172 7
11 16.10 68 34-122 14.78 74 37-133 10
21 31.44 67 41-102 29.57 71 44-109 20
5
9.71
51 17-120 8.89
56 18-131
5
39
8.11
481 342-657
9.11
428 304-585 37
18 19.21 94 55-148 18.89 95 56-151 16
11.55 nr nr nr
89.21 8.07 16.01 28.79 9.91 5.77 18.40
104 54-181 ~ ~ 111 90-135 87 35-179 63 30-115 70 42-107 50 16-118 641 450-884 87 50-141
Page I of6
C M A 171104
*
Cause of death Peritoneum & other digestive organs
Respiratory system Larynx Trachea, bronchus & lung Other respiratory system
Prostate Kidney Bladder Skin Eye Brain & other nervous system Thyroid Bone Connective & soft tissue Lymphatic & hematopoietic
Lymphosarcom a/ret iculosarcoma Hodgkin's disease Leukemia & aleukemia
Obs 5
128 3 122 3 15 1) 6 7 2 22 2 2 7 37 10 3 12
Applied Epidemiology, Inc. baseline analysis
Wonget 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% Cl
1.65 302 98-706 1.82 274 89-640 4
nr -
132.71 5.44 125.56 1.71 16.55 9.53 8.58 8.28 0.32 13.61 0.74 1.66 1.84 36.91 7.77 5.16 14.73
96 80-115 151.35
55 11-161 5.94
97 81-116 143.58
176 36-513
1.83
91 51-149 15.59
115 58-207
9.73
70 26-152
8.34
85 34-174
8.34
628 76-2269 0.42
162 101-245 13.05
269 33-972
0.73
120 15-434
2.19
381 153-785
1.91
100 71-138
37.29
129 62-237
7.72
58 12-170 5.31
81 42-142 15.03
85 71-101 115
50 10-148 3
85 71-101 111
164 34-480
1
96 54-159 15
1)3 56-202
11
72 26-157
5
83 33-171
6
475 58-1717
0
169 106-255 23
274 33-989
2
91 11-330 2
367 147-755
6
99 70-137 37
130 62-238
11
57 12-165 3
80 41-139 13
122.25 5.24 115.87 nr 15.20 9.06 8.46 7.36 0.31 12.76 0.68 1.81
nr 36.28 7.98 5.45 13.94
94 78-113 57 12-168 96 79-116 -99 55-163 121 61-217 59 19-138 82 30-178 0 180 114-271 293 36-1059 111 13-399 -102 72-141 138 69-247 55 11-161 93 50-159
Page 2 of6
C M A 171105
*
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 eta!., 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
C M A 171106
Page 3 of6
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 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% 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 (he 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 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
C M A 171107
Cause of death Diseases of the respiratory system
Pneumonia Chronic & unspecified bronchitis Emphysema* Asthma Pneumoconioses & other respiratory diseases (includes COPD) Emphysema & 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 I 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% Ci
Exp SMR 95% Cl Obs
Exp SMR 95% CI
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
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 --
C M A 171108
Page 5 of6
Cause of death
Diseases of musculoskeletal system & connective tissue
Obs 1
Applied Epidemiology, Inc. baseline analysis
Wonget 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% 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
Alt external causes Accidents Violence Suicide Homicide
Other causes
183 226.58 117 153.26 66 73.32 49 53.89 17 19.43 15 25.00
81 76 90 91 87 60
69-93 63-91 70-114 67-120 51-140 34-99
256.67 175.92 81.75 55.51 26.24 25.49
71 67 81 88 65 59
61-82 55-80 62-103 65-117 38-104 33-97
168 225.97 108 150.16 60 nr 46 52.78 14 nr
7 nr
74 72 -87 --
64-87 59-87
64-116
Unknown
28
1__--__
nr=no rates available for category of death
* In the NiOSH categories of death (used in AE1 baseline analysis), deaths from emphysema (1CD-7 527.1; ICD8 492; 1CD9 492) are included in Emphysema
and deaths from COPD (ICD-7 527.2; 1CD-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
C M A 171109
Page 4 of 5
Vinyl Chloride Health Committee Activities
timeline for finalizing the Guidelines.
DEADLINES
07/28/97
IMPORTANCE
" EPA / PETITION TO RAISE THE "REPORTABLE QUANTITY" (RQ) OF VINYL CHLORIDE
The Vinyl Institute will take the lead on determining whether a petition to raise the RQ is feasible. The VCHC will provide technical expertise if the VI decides that it is feasible. Caffey Norman wilt provide background on the criteria for determining the RQ.
ACTION ITEMS DEADLINES
IMPORTANCE
EPA / AIR TOXICS PROGRAM
ACTION ITEMS
EPA identified vinyl chloride and 36 other chemicals as "high priorities" for regulation under its Air Toxics Program. The Agency plans to develop a comprehensive integrated strategy for establishing an "air toxics management model." Caffey Norman provided background on EPA's activities with the Air Toxics Program, and CMA has asked to be a stakeholder.
DEADLINES
IMPORTANCE
ASSOCIATION OF PLASTICS MANUFACTURERS IN EUROPE (APME) / REGISTRY OF CASES OF ANGIOSARCOMA
APME has developed a protocol for the maintenance of a register of cases of angiosarcoma related to PVC production.
ACTION ITEMS CMA will monitor the development of the registry. DEADLINES
IMPORTANCE
C M A 171004
AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENISTS (ACG1H) / INITIATIVE TO LOWER THE THRESHOLD LIMIT VALUE (TLV> FOR VINYL CHLORIDE
The concern from ACT ill 1 is based on an article by Simonato, et al. in the Scand J. Work &
l- l i
AC T,111 met on C k lubei S, h, 7, IWo in Philadelphia. Peter de ta Cruz of Keller & Heckman cVniQ Institute} uspi Mulist to 1 >i William Waddell of the Univ. of Louisville (ACGIH) for 1 lank tiuuTli
ACTION ITEMS The Committee will examine the Simonato paper and make contact with William Waddell to propose presenting information to ACGIH.
DEADLINES
Page 5 of 5
Vinyl Chloride Health Committee Activities
07/28/97
IMPORTANCE
CALEPA / DEVELOPMENTAL AND REPRODUCTIVE TOXICANT (DART) 1 IDENTIFICATION COMMITTEE PRIORITY LIST
Vinyl chloride is a potential candidate for listing under Proposition 65. The VCHC submitted comments to CalEPA.
IMPORTANCE
ACTION ITEMS The Committee will monitor this issue.
DEADLINES
C M A 171005