Document MM18wG8ZjpdgEDr13wq891jxV
R&S 109619
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BIO-MEDICAL.RESEARCH DOCUMENT DESCRIPTION FORM
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____40 4160 61 62
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separated from each other with comma-space. Avoid other punctuation;
do not abbreviate. 12
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61 62 21
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Source (Journal, Vol., Number, Pages,Date )
61 62 31 32
Brief Summary
12
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SUMMARY:
61 62
61 62 63 64
R&S 109620
PLASTICS COMPANY
TELEPHONE; 213-32S.Z000
February 4, 1980
Dr. T. R. Torkelson The Dow Chemical Company Health & Environmental Research 9008 Building Midland, Michigan 48640
Dear Dr. Torkelson:
Attached is a copy of the "Pasternack--Firestone" cohort study of employees exposed to VCM. This study was part of the presentation ' Firestone made at the June, 1974 OSHA hearings concerning the pro posed VCM standard. As we discussed, one of the criticisms of this study was the selection of tire workers as the comparison group. You will note, however, that Dr. Pasternack also compared the Firestone Plastics Company employee deaths to the relative frequency of specific causes of death among U.S. white males in 1988.
I hope this information will be of value to you. Should you have further questions, I would be happy to attempt an answer.
Sincerely,
Technical Manager
RWA:djs
Attachment
FIRESTONE PLASTICS COMPANY . DIVISION OF THE FIRESTONE TIRE & RUBBER COMPANY BOX 699, FIRESTONE BOULEVARD, POTTSTOWN, PENNSYLVANIA 19464
PLASTICS COMPANY
Jf**/ /=/'4T
TELEPHONE: 215-326.2000
April A, 1979
Dr. T. R. Torkelson The Dow Chemical Company Bennett Building 2050 Dow Center Midland, MI 48640
Dear Ted:
At the March 50, 1979 meeting of the SPI-FVC Safety Group it was suggested that manufacturers who were in possession of worker epidemiology studies send these data to you. Enclosed is a study by Dr. Bernard S. Pasternack titled "A Proportional Mortality Study of Workers Exposed to Vinyl Chloride 194-7-197AV - This study was incorporated into the statement presented to OSHA during the June, 1974- hearings.
If you have any questions regarding these data, please do not hesitate to give me a call. Best wishes for a pleasant summer season.
Sincerely,
Russell A. Park
lfc cc: Mr. T. C. Walker
Mr. John R. Lawrence Technical Director The Society of the Plastics Industry 355 Lexington Avenue New York, NY 10017
Mr. D. C. Nuechterlein Dow Chemical USA 2020 Dow Center Midland, MI 48640
Enelo stire
R&S 109621
FIRESTONE PLASTICS COMPANY . DIVISION OF THE FIRESTONE TIRE & RUBBER COMPANY BOX 699, FIRESTONE BOULEVARD, POTTSTOWN. PENNSYLVANIA 19464
R&S 109622
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A Proportional Mortality Study of Workers Exposed to Vinyl Chloride 1947-74
GOn
* *5
1
R&S 109623
by
Bernard S. Pasternack, Ph.D.
SUMMARY The mortality experience oj\Jt33^dmfcloyees who worked at^ The Firestone
Tire & Rubber Company Pottstovn complex and died during the period 1947-74 has been examined. \ Eighty-five of the 433 deceased employees worked in the chemical plant or plastics plant and were exposed to vinyl chloride; the remaining 348 worked in the tire plant and were not exposed to vinyl chloride. Death certificates were obtained for all 433 employees and the
* cause of death was coded according to the 8th revision of The International Hot of Diseases and Causes of Death (1967) by Michael Baden, M.D. Twelve additional employees have been identified as having died in the period 1947-74 (2 exposed and 10 nonexposed) but cause-of-death information was not available for these employees at the time of this analysis. The 445 employees who died since 1947 includes all workers who died while employed by Firestone or after their retirement. In addition. Firestone identified all of the employees who worked at Pottstown since 1947, had at least three years exposure to vinyl chloride, and terminated for some reason other than death or retirement. Of the 228 employees in this category (out of a total of 750 employees known to have worked in either the chemical plant or plastics plant), Firestone was able to trace all but 18 (8%) and verify that they arc
-1/
/
/
still alive (207 or 91%) or deceased (3 or 1%).
* '
on nonexposed ex-employees.
No follow-up was performed
* ti
There was an excess of malignant neoplasms in both the exposed and
nonexposed employees, and a statistically significant excess in major cardio
vascular deaths in the nonexposed emp* loyees, compared with the U.S. male population (1968) adjusted for age at death (Table 1). Comparison of the
exposed employees with the nonexposed employees shows a slight excess in
malignant neoplasms and a small deficit in major cardiovascular deaths In
the exposed (Table 2)--neither statistically significant. Further comparisons
P'
-J----------------------- :--------------------------- -
involving 4 subgroups of the exposed employees (< 10 years work exposure;
S 10 years work exposure; "low" level exposure; "medium" level exposure) show
no significant differences between observed and expected deaths (Tables 3-8). --------- 1
Two findings should be stressed:
(1) One death due to angiosarcoma of the liver was confirmed in an employee,
classified as having had "medium" level-exposure, who died in 1969 at the
age of 51--21 years after first exposure to vinyl chloride (with 19.4 years
of work exposure). This single angiosarcoma death was the same one previously
identified (independently) by Firestone.
/
(2) The ages-at-death were significantly lower in the exposed employees
compared with the nonexposed employees (P < .05); the mean ( S.D.) ages of death
being 55.3 ( 13.1) " exposed and 59.5 ( 14.6)-nonexposed (Tables 9 and 10).
In particular, 21 out of the 22 deaths due to malignant neoplasms (95.5%) for
the exposed employees occurred at ages < 65 compared with 44 out of 73 (60.3%)
for the nonexposed. This difference is statistically significant at the
0.01 probability level. On the other hand, 32 out of the 46 deaths due to
major cardiovascular diseases (69.6%) for the exposed employees occurred
*
at agC3 < 65 compared with 121 out of 218 (55.5%) for the nonexposed--a
R&S 109624
-2; *7 3
dfifference that is not statistically significant. Thus, the earlier ages noted for the cancer deaths in the exposed group of ` employees may not be solely attributable to a presumably younger cohort at risk.
R&S 109625
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m4
.t
R&S 109626
TABLE 1.-Observed and expected number of deaths due to selected causes among exposed and nonexposcd employees, 1947-74
?<-7
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Cause of death
.List No.+
Observed (and exnectcd) deaths
Exposed
Nonexnosed
Malignant neoplasms
Digestive
Liver Respiratory system
Urinary organs
Brain
Lymphatic and hematopoietic
Other
Major cardiovascular
Cirrhosis of liver
Accidents
Suicides
All other causes
.Total
140-209 150-159
155
p
160-163 188-189
191 200-209
--i
390-448 571
800-949 950-959
--
0-989
22(15.4)
73(61.1)
8(4.3)
24(17.5)
13
U(5.4) 1(0.8) 1
25(19.9) 3( 3.5) 3
CD
1(2.1)
3 46(41.1)
11
JLX,
218(178.5)
3( 1.8)
. 4( 5.7)
8( 8.0)
21( 28.9)
0( 2.5)
6( 8,3)
6(16.2)
26( 65.5)
85(85,0)
348(348.0)
+ Age-adjusted expected numbers determined from relative frequency of specific
causes of death among U.S. white males in 1968.
'Eight];revision of International List of Diseases and Causes of Death, 19G7.
^Statistically significant difference (P < 0.01).
* .* * TABLE 2.-Observed and expected
number of deaths due to selected causes, with chiamong exposed employees, 1947-74
Cause of death
4
Number of deaths List No.+ Observed Expected
Mantcl-Hacnszel summary
Chi-seuarc values
* Malignant neoplasms
140-209
22
19.4
0.36
Digestive
' 150-159
8 6.5
0.23
Liver
..
155
1 1.0
0.33
Respiratory system
. 160-163
. .8
. 6.8 '
.. 0.11
Urinary organs
.188-189'
'l 0.7 . 0.09
1
)
1
'H
o->
' Brain. '
` '
19i
Vi '
` 0.33
*
.Awnrohatic and hematonoi.etic
'
Other
200-209 ' ' *
.1 .3
1.9; ' 2.5
0.00 -
Major cardiovascular .Cirrhosis of liver Accidents Suicides All other causes
390-443 C ' . 571* . 800-949
950-559
46 50.5 3 * 1.6 8 6.7 . 0 1.1 6 5.7 '
. 1.08 . ' .0.65
` 0.18 ' 0.46 -
Total-
0-989 '
85
85.0
-
'Age-adjusted expected numbers.determined from relative frequency of specific causes of .death among the 348 nonoxposed employees, with adaptation of Che MantclHaenszcl procedure.
`{S'ce footnote, table 1.
R&S 109627
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TABLE 3.-Observed and expected number cf deaths due to selected causes, with chisquare values, among employees with < 10 years work exposure, 1947-74
Cause of death
*
List Ko.*f
Number of deaths Observed Exnected
Man.tel-liaer.sael summary
Chi-sauare values
Malignant neoplasms
140-209
16
12.2
Digestive Liver
150-159
B*
6
4.0
155
0 . 0.6
Respiratory system
1(30-163 '
7 4.5
Urinary organs
. ' ` 188-189
Brain
191
Lymphatic and hematopoietic
200-209
0
6.8
/0 *
1
0.6 . 1.4
Other
'
-----; . .
2 0^6
lfajor cardiovascular Cirrhosis of liver .
t ' . 390-448 t*
571
26 `1
,31.0 0.9
Accidents
800-949
7
4.9
Suicides
/ . 950-959
0
0.8
All other causes
--3
3.2
Total
y'
0-989
53
53.0
1.37 0.71 0.01 1.17 0.23 0.01 . 0,02 ;; . / '2.10 , 0.25 0.87 0.13
-
See footnote, table 2. See footnote, table 1.
30 a 0) o 10 0M)
00
111
TABLE A.-Observed and expected number of deaths due to selected causes, with chiequare values, among employees with = 10 years work exposure, 1947-74
Cause of death
* List No.*}*
Number of deaths Observed Expected
Mantel-Kaenseel summary
Chi--square values* 1
Malignant neoplasms
140-209
' Digestive
ISO-159
Liver .Respiratory system Urinary'organs
; . '* .155 .
. . 160-163 188-189
Brain
191
Lymphatic and hematopoietic Other
200-2C9 --- ' *
Major cardiovascular Cirrhosis of liver
390-448 * *,# * * 571
Accidents Suicides All other causes
. 800-949 950-959 --
Total
0-989
6.
6.8
0.01
.' 2 1
2.2 0.4 '
o:o4 T *\ 0.05
1 ' ,2.2
0.26
1 f1 '
0:3 0.4
0.08 0.05
0 0.7
0.05
1:
1.0
-
20 20.2
0.01
2 * 0.5
` 1.88
'1
1.7 * .
' 0.04
o'
* * * * * ?** '
' 0.5 *
** ,
0.00
3 2.3
-'
32 32.0
. .. -
See footnote, table 2. 1See footnote, table 1.
R&S 109629
'T TABLE 5.-Observed and expected number of deaths due to selected causes, with chi-
square values, among employees with < 10 years work exposure, 1947-74
Cause of death
**
List Ko-T
Number of deaths Observed Expected
Mantel-Kuonszel summary
Chi- seuare values
Malignant neoplasms Digestive Liver .
. .` : ` -
140-209 . 150-159
155
16 14.8
0.15 `
6 i 5;5
0.00
#*
0
0.7 ` *
0.15
Respiratory system Urinary organs
Brain
160-163 1G8-1S9
191
7
6 ro'
' 5.2 .0.7
0.7 \
1.12 . .0.15
0.06
Lymphatic and hematopoietic-
Other
.
* .
pno-o^o
*
- 1
2
!^-- .2.0-
*0.28
*
** *
Major.cardiovascular
Cirrhosis of liver
Accidents
Suicides
-
All other causes .
.390-448
26
26.9
: 57i` 1 '1.7;''
0.04 0.07"
800-949 950-959
7 0
5.7
.' `
o.b
0.48 0.00
--
3
3.9
- ..
Total
0-989
53
53.0
-
i
i f i > t t e
i
{ \ J
\ $\
<,
<1,
5
5i
i >
\ { i i ti 1i i*
'Age-adjusted numbers determined from relative frequency of specific causes of death among the 32 employees with ^ 10 years work exposures, with adaptation of the Mantcl-llaenszel procedure-
t'Sea footnote, table 1.
R&S 109630
/?*?
'
'
I
R & s 109631
}* TABLE 6."Observed and expected number of deaths due to selected causes, with chi-
square values, among employees in the ulow" level exposed group, 1947-74
List No.*H
Number of deaths Observed Kxoected
Mantcl-Hacnszel summary
Chi-square vaIvies
Malignant neoplasms
140-209
U
10,2
0.01
Digestive Liver
Respiratory system Urinary organs
. 150-159 155
160-163 . 188-189
3 1 `4 f-
3-4. * 0.5
3.6 0.3
0.42 0.00
' 0.00 0.28
Brain
" 191
Lymphatic and hematopoietic
200-2C9
iy,'l * . . 0
0.5 \ " 0.00 . ) 1.2,- . ; ' ' 0.11
ther
` -- ' * 1 1.2
'-
Major cardiovascular
Cirrhosis of liver
Accidents
Suicides
'-
All other causes
.390-448 ` 571'
800-949 950-959.
---
26
2 7'
0 1*
27.6 1.0 4.6 0.8 2.8
. 0.13 0.35
1.15 # 0.12
-
Total
/
0-989
47
47.0
-
See footnote, table 2.
tSee footnote, table 1.
Jto
TABLE 7.-Observed and expected nunber of deaths due to selected causes, with chisquare values, among employees in the "medium" level exposed group, 1947-74
Cause of death .
* 4* Nunber o f deaths List No .*}* Observed Expected
Mantel-Haenszcl sunna ry
Chi-seuare values
Malignant neoplasms .
140-209
11
8.6
0.62
Digestive
150-159
3 2.8 * 0.03 .
Liver
155
1
0.5 '
0.00
.Respiratory system
160-163
` 4 . 2.9
0.14
Urinary organs
Brain
Lvmphatic and hematopoietic , ^ **
Other
188-189
1 0.4
191
f'1-
`To^
{
ono-Tno *
\ o 0.9/
V__ .__ ,
^*
" 2 .
i.i.;
. *0.03
0.00
0il9 ' -
,
Major cardiovascular
''. 390-448
20
23.9
" 1.52
Cirrhosis of liver Accidents Suicides All other causes Total
571* ' 800-949
950-959 --
0-989
1 1 0 5 38
0.5 *' 1.9 . 0.5 ' 2.6 38.0
` .0.00 4 * V
0.11 . 0.00
1 ^*
J
1
3 37 (/)
CCoTO> s CroO
See footnote, table 2. Sec footnote, table 1.
/
t
TABLE 8.-Observed and expected"'" number of deaths due to selected causes, with chisquare values, among employees in the "low" level exposed group, 1947-74
Cause of death
> List Ko.'f
Number of deaths Observed Exdgc ted
Mantel-Haenszel summary
Chi-souare values
R&S 109633
' Malignant neoplasms
Digestive
.
Liver
Respiratory system
Urinary organs
'.
Brain
^Lymphatic and hematopoietic
^^ther
Major cardiovascular
Cirrhosis of liver
*
Accidents
Suicides
All other causes
Total
140-209
ii
12.5
0.25
. 150-159 155
160-163*
5 **
. 0.
*- . ' 4
4.6 0.5 .-4.4.
`0.00
* o.o'o
0.00
188-189 191
200-209
0 0.6 y ~ - _ - ------ X f 0 0.5 v
0.7 )
>1..
0.01 . 0.00
0.28
. ----- *
1 1.7
390-448
26
24.0
0.48
571* .800-949
950-959 * . -----
2 7 "0 1
. 1.5 '5.3 0,0 3.7
0.00 1.01 0.00
-
0-989
47
47.0
-
4. 1 c
Age-adjusted numbers determined from relative frequency of specific causes or
death among the 38 employees in the "medium" level exposed group, with adaptation
of the Mantcl-llacnsael procedure.
1, 'See footnote, table 1.
feE960l- S^y
4
Table 9.-Distribution of deaths by age and cause for exposed and nonexposed employees, j.
123
Cause of Death Malignant neoplasms
Digestive
Respiratory system
. Urinary organs
*
Lymphatic and hematopoietic Major cardiovascular Cirrhosis of liver
Accidents Suicides
All other causes
.*
List Ko.'t'
Groups
140-209
E. NE
150-159
E NE
160-163
E NE
188-189
E NE
200-209 E >1. NE
' 390-448
E. NE
571 .
E NE
800-949
E NE
950-959 --
E NE
`e NE
Age at Death
t 34'
0 0
35-44
3 11
45-54
5 15
55-64
13 18
.
0 0
0 0
o 0
0 0
0 '* 3
0 0
1 2
1 5
0*.0
1 0
'4 *'13
.
0 1
3 6
0 3
1 0
0 4
19 47
1 2
4 5
6 8
0 ..1
0 2
9, 58
1 1
41
3
11 4 5
0 0
00 12
o 0 10
0 3 1
33
4
1 2
65
1 29
0 11
1 9
0 2
0 1
14 97
1 0
0 1
0 2
1 14
Total
22 . ?3
8 24
8 25
' 1 3
1 7 46 218
3. 4
8 21
0 '6
6 26
Total
0-989
E
NE
4 18 .
11 34
29 74
24 17 85 79 143 348 ;
E " Exposed. ME " Nonexposed.
*532 footnote, table 1.
I
-I1I I
*rII
I 3
TABLE 10.-Distribution of age at death by year of death for exposed and nonexposed groups
I i
i
ii i
Ase at Death
Year of Death
Group
< 34
35-44
45-54
55-64
65
Total
1947-54 ii 1955-59
E1 . NE 8
E1 NE 4
00 3 11
0 8
*
3'- 3
1
798
0 -* 3 T-
. .0 17
1 33
8 45
1960-64 1965-69 '
E NE
`E NE
0 2
1 2
4
2 11 * *
3 10
10 14 .
9 23
6 16
6 18
1,' 31
3 39
19' 74
22 .92
1970-74 X v Let Ju
E NE
.E ' NE
t E 3 Exposed NE = Konexposed
13 23
4 . 11 18 34
7' ` 17
29 ' 74
11 29
24 79
13 53
17 143
35 104
85 348
88960L SSH
MICHAEL M. BADEN, M.D, 520 >'I Ji.ST avenue NEW YORK, NEW YORK 10016
Juno 19, 1974
Mr. Arthur Smith 39 South Lasalle Street Chicago, Illinois G0603
Dear Mr, Smith:
I have reviewed 433 death certificates and the vinyl chloride exposure records
of 445 employees identified by the l'irestone Company as the total number of
workers at the Potts town complex who have died since 1947. Included arc 85 of
87 employees who were exposed to vinyl chloride. Thus 97.3 % of all deaths
and 97,7% of the vinyl chloride exposed deaths were examined. Hospital
records and histologic slide material were reviewed by me when indicated,
*,,
#
The major findings can be separated into four categories:
1. Angioscarcoina: One angiosarcoma of the liver was identified (which I bad not known was pz'eviously known to Fiz'estone) and no other angiosarcomas were found among the 433 decedents. This tumor occurred in a 51 year old male in the long exposure higher concentration group 21 years after initial exposure. A single tumor, even a rare one such as angiosarcoma of the liver, can occur spontaneously andjby itself, its significance cannot be propferly evaluated. However, when considered together with other data presently available which was not known at the time of the death in 1969, including recent animal studies and reports of angiosarcomas in vinyl chloride exposed persons elsewhere, it appears that this angiosarcoma is consequent to the vinyl chloride exposure.
2. Malignancy in general: There was no significant increase in deaths from any specific malignancy in the exposed and non-exposed employees as demonstrated by Dr. Bernard Pasternak's statistical evaluations. A slight excess of cancers of the respiratory and digestive systems present in both groups when compared to the.total United States white male population must bo further examined as to smoking habits of these groups and other local environmental factors (including fads among physicians in determining cause of death in non-autopsied fatalities.) This examination should include.- evaluation of Potts town employees who are still alive. Such evaluation of living employees is also necessary to further evaluate the finding by l)r. Pasternak, on the basis of information presently available, that the moan age of deal): from all causes of exposed employees (55,3 years) was less than for non-exposed employees (59.5 years). There may ho reasons for this difference other than exposure to vinyl chloride.
R&S 109636
R&S 109637
Smith
-2-
Juno ID, 1973
The median ace of'death of those dying of cancer in the exposed group (22/65) is the same as the median age of death of those dying of cancer in the lion-exposed group (73/346) -- 58 years). There is no greater number of early deaths from cancer in the exposed group. However, in the exposed group the oldest death from cancer was 67; in the non-exposed group 19 deaths from cancer occurred between 71 and 87 years of age. This difference may be an artifact caused by initial population ago differences but should be explored further. There is no difference in all causes of death among the 32 decedents exposed to vinyl chloride for more than 10 years as compared to the 53 decedents who had briefer exposure;and among the 22 malignancies in the exposed group there is no difference in type of cancer in those exposed more or less than 10 years (except for the one angiosarcoma in the longer exposed group).
3. Cirrhosis of the liver: The three fatalities attributed to cirrhosis of the liver in the exposed, population and four in the non-exposed population may be accounted for on the basis of alcohol consumption, a highly significant factor in evaluating the etiology of cirrhosis and a factor which is noticably not mentioned in the medical chai'ts I was able V: to examine.
4. The Tabershaw and Gaffey study: This mortality study, a draft of which I reviewed which may not be the final report, evaluates mortality rates employing data on living as well as dead employees exposed to vinyl chloride in 34 plants. 6384 workers wei*e identified of which 352 wore known to have died and 326 death ccrtificates were reviewed (in 1256 or 15% of the workers they had not yet been able to determine whether the individual was still alive). Dr. Tabershaw states that "This is the first epidemiological study which suggests that in humans vinyl chloride may also be associated with cancer of multiple sites." (The only published repox*t ho refers to in support of-this concern is work by Viola in which "large doses of the chemical in rats produced cancer of the skin, lung and other organs." When Viola's work was reviewed by Maltotii, the latter concluded that those wore not primary cancers but wore metastasos from JJymbal gland tumors which tumors are produced by a largo variety of carcinogens and arc not specific for vinyl chloride.) PrT Tabershaw'.Sdata gugg^f^ tHn-t in hi]|i;nnt; vinyl chloride exposure may cause an increase
] in cancel's of the digestive system (primarily angiosarcomas), respiratory system (primarily lung cancer), brain, unknown sites and in lymphosarcoma: Lung cancer - this is the most common fatal malignancy in males in the United States; there was a slight excess of this tumor in the Firestone population in both the exposed and non-exposed groups. The significance of this finding can only be evaluated after dbtaini.ng adequate smoking histories.
/i )
t I
Mr, Smith
-3- Junc 19, 1974
Brain can cor - there was only ono death from a brain tumor in the exposed Fii*estonc group and there were three in the non-exposed group. As Mr. Taborshaw indicates deaths diagnosed as due to.primary brain cancers may include metastatic cancel's from other undiagnosed primary sites, especially from the lung. (In only one of Dr. Tabershaw's six cases is. an autopsy listed as having been performed). Byrnphosarcomn - there was only one death from lymphosarcoma indicated on the death certifications in the exposed Firestone group. On further review of this decedent's medical records (after Dr. Pasternak's study was completed) it became apparent that the cause of death was not a lymphoma but rather . a metastatic cancer, probably from the trachea. This demonstrates the necessity of not accepting death certificates at face value. Dr. Tnbershaw found six lymphosarcomas in his study which apparently was limited to a review of the death certificates. Cancer of unknown sites - includes many different typos of cancer and cannot be evaluated without reviewing each decedent's medical and autopsy records.
Thee-above represents a preliminary evaluation of vinyl chloride exposed and non-exposed employees from the Pottstown Firestone plant who have died. This group should be evaluated together witji employees who have not died so that mortality incidences can be determined and maximal information can be obtained. This further study should include information as to smoking and alcohol habits.
The issue of threshold still remains to be resolved but there may be a level beneath which exposure to vinyl chloride is not harmful.
Sincerely,
MMQlfp
Michael M. Baden, M.D,
* * * fV.Vt.
>? J V U A J J
R&S 109638
/87
* -- . * ,, .
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