Document 4aDed6bwj7QBq5g27dVbZJNkx
ia Chemical Manufacturers Association
URGENT
February 27,1998
Dear Vinyl Chloride Health Committee Members:
Attached is a letter and data table from Dr. Ken Mundt. Please review the information with your appropriate company representative as soon as possible. In addition, I have enclosed a calendar for setting up a VCHC conference call to discuss the information. Fill out the calendar and fax it back to me at 703/741-6091.
If you have any questions, I can be reached at 703/741-5639.
Sincerely,
Attachments(2)
Wendy K. Sherman Manager, Vinyl Chloride Health Committee
CUtlllllKO
125
Innovation, Technology and Responsible Care At Work 1300 Wilson Blvd., Arlington, VA 22209 Telephone 703-741-5000 Fax 703-741-6000
CMA 171023
FEB 27 '98 12:56 TO 17037416091
FROM Applied Epidemiology T-731 P.02
APPLIED 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 ortwo 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 ofdeath 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 ofthe 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
{413) 256-3556 FAX (413) 256-3503
CMA 171024
FEB 27 '98 12:57 TO 1703741S091
FROM Applied EpidemioIogy T-781 P.03
(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 ofthe 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 "angiosarcoma1' 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 171025
'*
'FEB 27 98 12:57 TO 17037416091
FROM f lp p li d E pidem iology T-781 P.04
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 LT.S. white male mortality rates, plant state-specific white male mortality rates, for follow-up through December 31,1982
Cause of death AM causes
Obs 1569
Applied Epidemiology, Inc. baseline analysis
U.S. reference rates
Stale reference rales
Exp SMR 95% Cl
Exp SMR 95% Cl
1734.92 90
86-95 1876.87 84
80-88
Obs 1536
Wong el ai, 1992
U.S. reference rates
Exp SMR 95% Cl
1705.27 90
86-95
AM maligiaut neoplasms Cancer of:
Buccal cavity & pharynx Tongue Other parts buccal cavity Pharynx
Digestive organs & peritoneum Esophagus Stomach Intestine, except tectum 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
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
Page 1 of6
C M A 171026
C M A 171027
Cause of death Peritoneum ft other digestive organs
Respiratory system Larynx Trachea, bronchus ft lung Other respiratory system
Prostate Kidney Bladder Skin Eye Brain & other nervous system Thyroid Bone Connective ft soft tissue Lymphatic & hematopoietic
Ly mphosarcoma/reticu 1 osarcoma Hodgkin's disease Leukemia &. aleukemia
Ohs 5
128 3 122 3 15 11 6 7 2 22 2 2 7 37 10 3 12
Applied Epidemiology, Inc. baseline analysis
||
U.S. reference rates
Slate reference rates R
Exp SMR 95% Cl 1.65 302 98-706
Exp SMR 95% Cl Obs 1.82 274 89-640 4
Wong et a!., 1992 U.S. reference rates
Exp SMR 95% Cl or -
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-U6 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 33-972 120 15-434
0.73 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
8S 71-101 111
164 34-480
1
96 54-159 15
113 56-202
11
72 26-157
5
83 33-171
6
475 58-1717
0
169 106-255 23
274 33-989
2
91 L1-330 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 0.3! 12.76 0.68 1.81
nr 3628 7.98 5.45 13.94
94 78-1 (3 57 12-168 96 79-116 99 55-163 121 61-217 59 19-138 82 30-178 0 ISO 114-271 293 36-1059 1(1 13-399 102 72-141 138 69-247 55 11-161 93 50-159
Page 2 of6
FROM A p p lie d E pidem iology T-7B1 P.05
'27 98 12:57 TO 1703741S091
Cause ofdealh
Other lymphatic & hematopoietic
Unspecified
Benign & unspecified nature neoplasms
Unspecified nature of eye, brain & otlier nervous system
Other
Obs 12 29 7
4
3
Applied Epidemiology, Inc. baseline analysis
II
U.S. reference rates
State reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl Obs
9.25
130 67-227
9.23
130 67-227
10
22.37
130 87-186 25.13
115 77-166
23
5.70 123 49-253 5.54 126 51-260 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 al., 1992 U.S. reference rales
Exp SMR 95% Cl 8.37 119 57-220 nr -5.08 79 21-201
or
nr -
Diabetes raellitus
23 23.89 96 61-144 25.38 91 57-136 22 23.52 94 59-142
Diseases of llie blood & blood forming
2
4.17 48 6-173 4.37 46 6-165
2
3.76 53 6-192
organs
Mental, psycbonenrotic & personality disorders
Atcoltofism
Other mental disorders
7
12.74
55 22-113
13.15
S3 21-110
4
11.80
34
9-87
4
8.86
45
12-116
9.20
43
12-1 il
3
nr
-
3 3.87 77 16-226 3.94 76 16-222 l
nr
C M A 171028
Page 3 of6
'FEB 27 99 12:58 TO 17037416091
Cause of death
______________
Diseases of the nervous system & sense organs
Multiple sclerosis
Other diseases of nervous system & sense organs
Qbs 14
3 11
Applied Epidemiology, Inc. baseline analysis
1
U.S. reference rates
Slate reference rates I
Exp J7.29
SMR 81
95% Cl 44-136
Exp 17,40
SMR 80
95% Cl | Obs
44-135
15
2.31 14.98
130 27-380 73 37-131
1.87 15.53
161 33-470 71 35-127
3 12
Wong el al., 1992 U S. reference rates Exp SMR 95% Cl
nr -
nr or
FROM A p p lie d E pidem iology T-7S1 P .07
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 M 19.33 72 40-122
533 583.71 92 84-100 630.80 85
78-92 1 488 597.73 82
75-89
5 3.55 141 46-329 3.17 158 51-368 3
nr -
3 7.89 38 8-1 It 5.84 51 1l-l50 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 syiteu
Hypertension without heart disease
109 129.73 84 69-101 143.51 76 3 4.53 66 14-193 5.06 59
62-92
103
12-173
8
nr nr
-
Cerebrovascular disease
78 86.64 90 71-112 96.46 81 64-101 70 91.93 76 60-96
Diseases ofarteries, veins & pulmonary circulation
28 38.55 73 48-105 41.99 67 44-96 25 nr -
Page 4 of6
C M A 171029
FEB 27 ' 98 12:59 TO l70c>741bt>91
C M A 171030
Applied Epidemiology, Inc. baseline analysis
| Wi>ng et af1992
U.S. reference rates
State reference rates H
U.S. reference rates
k Cause of death
Obs Exp SMR 95% Cl Exp SMR 95% Cl | Obs Exp SMR 95% Cl
Diseases of Ike respiratory system
70
91.93
76
59-96
111.60
63
49-79
70
87.61
80 62-101
Pneumonia
16 31.54 51
29-82
34.41
47
27-76
15 31.94 47 26-78
Chronic & unspecified bronchitis
2 4 38 46 6-165 5.44 37 4-133 2
nr -
Emphysema*
17 20.12 84 49-135 23.45 72 42-116 17 nr -
Asthma
1 3.00 33 1-185 3.76 27 1-148 1 2.89 35 1-192
Pneumoconioses & other respiratory diseases (includes COPD)
33
30.30 109 75-153 4121
80 55--L12 35
nr
-
Emphysema & COPD*
41 22.83 180 329-244
Diseases of the digestive system
63 97.55 65
50 S3
93.36
67
52-86
60 95.58 63
48-81
Diseases of stomach & duodenum
9 12.11 74 34-141 12.02 75 34-142 8 It.IS 72 31-414
Hernia & intestinal obstruction
2 3.81 53 6-190 3.83 52 6-189 2
or --
Cirrhosis of the liver Other digestive system diseases
38 56.70 67 14 24.93 56
47-92 31-94
50.91 26.60
75 53-102 | 35 53 29-88 ' 14
56.06 or
62 --
43-87 '
Diseases of the genitourinary system Chronic/unspecified nephritis Other genitourinary diseases
S 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
1
20.41 44 20-84 8.29 48 13-123 nr
Page 5 of6
*
'FEB 27 98 12:59 TO 17037416091
FROM rip p u e d E pidem iology F-731 r . 09
Applied Epidemiology, Inc. baseline analysis
Wonget al1992
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 & i 3.15 32 1-177 3.28 30 1-170 connective tissue
--
Symptoms & ill-defined conditions
All external causes Accidents Violence Suicide Homicide
Other causes
7
21.51
33
13-67
26.68
26
11-54
10 21.79 46 22-84
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 2624 65 38-104 14 nr -
15 25.00 60 34-99 25.49 59 33-97
?
nr
-
Unknown
28
97
nr=ao rates available for category ofdead) * In the NIOSH categories of death (used in AEI baseline analysis), deaths from emphysema (1CD-7 527.1; 1CD8 492; ICD9 492) are included in Empitysema and deaths from COPD (1CD-7 5272; 1CD-8 519.2; ICD-9 496) are included in Pneumoconioses dc other respiratory disease*, In the Mooson categories of death (used in Wong et al. analysis), Emphysema & COPD includes deaths from any ofthe following: Pulmonary collapse (1CD-7 527.0); Emphysema without mention of bronchitis (1CD-7 527.1); Other diseases oftlie lung (includes COPD) ((CD-7 527.2).
Page 6 of6
C M A 171031
02/27/98
MONDAY 9
Vinyl Chloride Health Committee Mar-98
TUESDAY 3
WEDNESDAY
4
to a
Please Fax to Cynthia Barrett at 703/741-6091
THURSDAY 5 onW (Wfc-i 1
FRIDAY 6
^`>(VVt^Sprn fS
C M A 171032
YOUR NAME: COMPANY.
Please Indicate the dates that you are NOT available for a Conference Call.
/Z\ CHEMICAL MANUFACTURERS
ASSOCIATION
FAX Cover Sheet
iTo:
QoJVUA
(hM\ 7//
Pnmpany ^/d Q
Telephone #:
Js7?Q
Fax Number d(* l ^ 3- YbID
From;
SkzAma^----_______
ChemicalManufacturers Association
(703)741-^31
Number of Pages (including cover sheet) 1L j3
CMA 171033
4
A
CHEMICAL MANUFACTURERS ASSOCIATION
FAX Cover Sheet
To: /If)Am --Company: Pq Telephone #: <3o fe/S~7~~PTO Fax Number 3o2./*t5 7'(c>3/S~
From:
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Number of Pages (including cover sheet) O _
CMA 171034