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I | Mortality Among Employees
? 1988
HMRIA1 NEVERJSKY
I
of PVC Fabricators
I
I Lf0njrd Chiazze, Jr., Sc.D,; William E. Nichols, PH.D.; and Otto Wong, Sc.D.
trassir>an
{ 4 (roo-sKtioiul mortality ttudy of 4,341 death* occurring l imong current and former employee* of 17 PVC fabricator*
during 1944.1973 i* presented. The objective* are: (1) to iden| ,j(, any angiosarcoma death* among the employees of these I ijbricators, and (2) to examine the distribution of death* by
ciuK. No angiosarcoma death* were found among the study | group. Sex-race-caute-tpecific Proportionate Mortality Ratio* , ipMR's! were computed, using the corresponding U.S. mor
ality as the standard. Among white employee*, there appear* to be an excess in total cancer mortality, particularly that of tho.dilpMMMNtRB. Observed deaths were found to exceed I thr expected in cancers of the breast and urinary organs
I among white females. Deficit mortality was observed in } cirrhosis of liver among both male and female white em
ployees.
The lanuary 1974 disclosure of three deaths from angio-
-arcoma of the liver in a single vinyl chloride polymerization plant and the attention focused on this new occupational disease are well known. A significant amount of information from animal ex perimentation and observation on humans engaged in the producon of vinyl chloride followed ' However, there was no informaion regarding the possible adverse effects on employees engaged n oolvvinyl chloride (PVC! fabrication, where potential exposures *ere thought to be low and to result from the release of unreact ed monomer trapped in the resin. This issue was considered of great import because of the very large number of workers believed :o be engaged In fabrication.
in March 1974, representatives of PVC producers, who are members of the Organization Resources Counselors (ORC), Oc cupational Safety and Health Standards Croup, contacted ORC about the feasibility of a study of health risks to employees workmg with vinyl chloride and polyvinyl chloride Since the National mititute Tor Occupational Safety and Health (NtOSH) was con flicting a study of vinyl chloride and resin producing employees, 'be scope of the proposed ORC study was limited to employees of
{,om in Division Qf Biostatistics and Ep*dem*otogv Department of Community international Health Georaetown University School of Medione,
'^shinqton DC 2000? Drs Chiazze and Wong1 and Organisation Resouces Couiv Inc Washington DC 20006 ;Dr Nicholsf
^ni of Occupational Medicine/Vol 19. No 9/September W97
companies engaged in the fabrication of PVC resin into finished products. A number of alternative study designs was considered, and it was decided that a proportional mortality study would best meet the urgent need for information. The study concentrated on deaths occurring during the ten-year period 1964-1973 among ac tive fabricating employees plus retirees Since it was not possible to identify those employees with only vinyl chloride exposure, the study focused on deceased employees who worked anywhere in those plants where PVC fabrication was carried on The primary objective of the study was to determine whether or not any angio sarcoma deaths had occurred among employees of the fabricators under study A secondary objective was to examine the distribu tion of all deaths by cause
The relatively tew producers of vinyl chloride monomer and of PVC resin are generally medium to large companies PVC fabri cators, however range from large plants of major companies to very small job shops Even in a large plant, there may be few em ployees who are in the vicinity of PVC resins The range of com pany plant size and number of exposed employees help to explain the wide range of estimates of total employment dependent upon PVC resins. Fabrication is geographically disbursed, with at least some Ofseration in almost every state Typical fabrication products include coated wire, upholstery fabrics, floor and wall coverings pipe and other construction materials, toys, recreational equip ment, phonograph records, containers and container lining, and a myriad of novelty items Since the fabrication of PVC resin into finished products is often a part of diversified product lines in a plant, raw materials other than resin are utilized Thus, employees may be exposed to toxic agents other than vinyl chloride Conse quently, in the current study, it is not possible to isolate only the effect of vinyl chloride Some departures from expectation may be due to exposures to vinyl chloride, to one or more other agents, to some combination, or to employee characteristics other than occupation.
Material* and Method*
The decision to focus on a cross-sectional mortality study rather than on an historical cohort study derived from several con siderations First, the primary study objective was to determine relatively quickly whether or not any angiosarcoma deaths could be identified among the study group, and this was best ac complished by examining causes of death among relatively recent
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(i e, past ten years) decedents. The desirability of identifying an historical cohort for follow-up was recognized, but it was deter mined that it would not be possible to identify clearly and com pletely the necessary cohort of workers within a reasonable period ot time if at all As a consequence, this study is based upon 4 341 deaths which occurred during the.period 1964-1973 among current or former employees of 17 companies engaged in PVC fabrication A total of S3 plants supplied data on all identifiable deaths since as was mentioned earlier it was not possible to iden tify those employees with only yinvl chloride exposure for the study
In order to be included in this study a deceased employee fell into one of the following categories. (Ii employee died while ac tively employed (2) employee died after retiring from the com pany with retirement benefits, and (3) employee died after ter minating employment but with vesting in a company-sponsored life insurance plan Deaths occurring among former employees with less than the number of years necessary for insurance vesting were not included in plant records and were, therefore, not available tor this study
An attempt was made to compensate for at least some of the "leakage" due to employees leaving the industry prior to the time they were vested in any insurance program by using the following procedures Once death records for a given company were identitied, death certificates were obtained and separated into two groups as follows (11 all deaths with cancer (ICDA 140-205 up to 1967: ICDA 140-209 for 1968 on), or liyer disease (ICDA 580-586 up to 1967, ICDA 570-576 for 1968 onl, or suspected liver con dition mentioned on the death certificate, and (2) all deaths from causes other than cancer or liver disease Death records men tioning cancer or liver disease and giving a hospital as place of death were segregated and sorted by hospital Where there were several death records for a single hospital or several hospitals in the same area arrangements were made for a Registered Records Administrator (RRA' to visit the hospitals review medical records, contact the hospital pathologist and review pathology records to determine whether there were any angiosarcoma cases in the hospital's pathology records If so, an attempt was made to deter mine whether or not the angiosarcoma possibly could be related to vinyl chloride exposure. This procedure enabled us to identify whether any employees, who had left the industry prior to vesting in an insurance program and remained in the local area, had died from angiosarcoma of the liver The hospital inquiry procedures turned up five deaths from angiosarcoma of the liver: according to company employment records, none were employed at any time in PVC fabricating plants These deaths were reported to 05HA, NIOSH, and CDC for inclusion in the nationwide angiosarcoma survey
Death certificates not mentioning a hospital as a place of death required an additional step to determine whether death occurred in a hospital or if a recent hospitalization had occurred prior to death The certifying physician was queried by mail tor in formation on recent hospitalization of the decedent and whether there was anv indication that he or she had cancer or liver disease Additionally identified hospitals were contacted as above
Originally, it was planned that death certificates would be ob tained from life insurance carriers In practice, both company and life insurance records were used because of record retention prac tices and retrieval problems in the insurance carriers All available death certificates were examined bv a trained nosologist for men tion of angiosarcoma anywhere on the certihcate and no angio sarcomas were found on the death certificates Underlying cause
624
of death was classified according to the eighth revision of the iP ternational Classification of Diseases '
Over the ten-year period under studv plant size was found y have cfianged drastically in many cases In one instance, a pUi i employing 300 employees in 1973 employed fewer than 10 ,- > 1964 At the other extreme, one plant employing 5,000 people m I
1964 had only 2,000 in 1973 Some companies had gone out r business Such developments show not only the rapid change ! taking place but also the difficulty of determining average industr, employment The 17 companies covered m this report ranger from single plant, small companies (one with 70 employees y multiplant large companies (one with over 7,000 employee Average number of employees clustered between 300 and 500 Although total employment is difficult to determine precisely, it estimated to have been between 65,000 and 70,000 at the end o1973
Since the population at risk could not be determined, morulit. rates as measures of risk could not be calculated Rather resultwere summarized in terms of Proportionate Mortality Ratios iPms ad|usted for the age distribution of the studv group The PMR u'e relative frequencies of specific causes of death by age in a coir parison population to obtain expected numbers of deaths iror that cause in the study population Selection of an appropru:, comparison population poses some difficulties since it would b* desirable to have a cause of death distribution for a similar grour of workers dying during the same period, but not sub|ected to the factor under studv. But such a comparison population was no: available, and the study used mortality for the United State specific for color and sex, for comparative purposes1 DW' recognized deficiencies, the PMR can provide clues on unu-~ distributions of causes of death where true rates cannot t> calculated
Refu Its
Table 1 gives the distribution of deaths among the employee4 f the 17 PVC fabricators within each of the ten years An increase14 the proportion of deaths taking place in later years of the decadf may reflect a variety of factors, such as an increasing employ population, less complete availability of records for earlier vea" (eg, in one company, there were no records for the first tour c the ten years), increase in duration of exposure, etc HowC'f there is no reason to believe that anv unavailable death record4 1 earlier years would be concentrated in a few causes and the,f` bias the distribution of deaths for those vears
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i , distribution of deaths in the study group bv race and set is ,n Table 2 Most deaths 184 7%i occurred among males The
' ma|0ritv (88 7%) of decedents were white and there were 288 ,0r whom race could not be determined Table 3 shows this
' ' itwt|0n of deaths by age. For both white male and white | employees more than half of the deaths occurred among
f aged 65 and over (581% and 51 9% for white men and w women. respectively) The corresponding proportions of I ej|6s which occurred after age 65 in the United States ^illation in 1968 were 59% and 72%, respectively) The higher I v100rtion of deaths among white women over 65 in the U S | YipulatiO" compared to the employee population may indicate , relatively fewer women work to retirement age than do men. v hl)^ the numbers of deaths among nonwhite employees are too j -ull for any definite conclusions, the distribution of deaths by te among nonwhite men is roughly comparable to that for the ,:1I united States. 'soles 4 and 5 show the distribution of deaths for selected |J-e. bv sex for whites and nonwhites, respectively Among l ,,-rte men, nearly 60% of the deaths are from diseases of the cirI j tiorv system (ICDA 390-458) and 20% are deaths from cancer I CD* 140-209' The corresponding percentages for the total U S stipulation of white males in 1968 (midpoint of the study period)
( ,,pe 54% for diseases of the circulatory system and 16% for caner Digestive and respiratory cancers account for somewhat less | -an two-thirds of all cancer deaths among the white males in the i .;odv group as compared to about 59% of all cancer deaths
J rnong U S white males in 1968 For white women, over 46% of
I nf deaths are from diseases of the circulatory system (compared s 51% for all U S white women in 1%8) . and 30% were from can s' compared to 18% for all U.S. white women in 1968)
| -iwwhat over half of the cancer deaths among white women in * study were from cancers of the breast and digestive system.
about the same proportion as tor all US white women in 1968 About two-thirds or the deaths tor both nonwhite men and women were from diseases ot the circulatory system and trom cancer The numbers ot deaths tor most causes among nonwhites, however are quite small making interpretation difficult and are presented mamlv for completeness
Age-ad|usted PMRs for white male and white female employees of the 17 PVC fabricators are presented in Table 6 tor selected causes of death There were no similar analyses tor nonwhites because for nearly all causes, the numbers of deaths were too small to produce stable PMRs Expected numbers of deaths have been calculated on the basis of the sex-cause-age specific distribution of deaths among U.S whites m 1968 applied to the total number of deaths by age among white men or white women in the study group The midpoint of the study period (1968) was selected tor the standard, since It IS representative of the study period and provides U 5. mortality data coded according to the eighth revision of the International Classification of Diseases fxpecred numbers are deaths for individual causes to be expected in the study group if the proportion of total deaths ascribed to a given cause were the same as for the corresponding U S, race-sex group, while accounting for differences between the age distributions of deaths in the study groups and deaths for the United 5tates A PMR larger than unity would indicate that the relative proportion of mortality from that particular cause in the study population is higher than would be expected based on the 1968 U S mortality experience Due to the nature of the data, for mal significance tests and interpretation in probabilistic terms are deemed inappropriate
in addition to the numerical value of the PMR itself, the ob served number of deaths is also of interest. The larger the number of deaths observed the more reliable the PMR There were two deaths ot unknown age among the white males, one a digestive cancer (ICDA 153' and one an unspecified cancer (ICDA 199) These were included m the age groups with the lowest relative frequency for those causes, that is, less than 35 years for total can cer and digestive cancer and 65 and over for other and un specified cancer 5uch an assignment has a trivial effect on the ex pectation but is the most conservative way of handling these unknowns since it serves to increase the expectation (and hence lower the PMR) by the least amount
Based upon both the number of deaths and the value of the PMR, there seems to be an important excess in total cancer mor tality among the white males in the study group. The distribution by specific cancer site suggests that any excess appears to be con-
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tentrated in digestive system cancer, given the large number of deaths (31% of all cancer deaths). For each of the sites within the digestive system, observed numbers of deaths are greater than ex pected. Although, except for intestinal cancer, the observed num bers of deaths are small. The PMR for liver cancer is rather high, out a definite conclusion is difficult with only six observed deaths On the other hand, the PMR for cirrhosis of the liver suggests a deficit in mortality from that cause.
For white women, the PMR for total cancer appears high, as it did for white men, with cancer of the digestive system and, perhaps, cancer of the breast contributing a fair amount to the ex cess The PMRs for individual sites within the digestive system are based upon small numbers but suggest an increase in intestinal cancer The PMR for urinary cancer, though based upon only 11 deaths, seems strikingly high and mav be an indication for further investigation On the other hand in contrast to the observation in white men the PMR tor respiratory cancer among white women is very close to unity Similar to the observation in white men, mor-
t.'t'tv from cirrhosis of the liver seems to be in deficit, but t** corresponding observed number of deaths is quite small Amun both white male and female employees, diseases of the circulaW^
system account for a large percentage or total deaths in ei\ case, observed numbers of deaths are close to expected Tt,f'
appears to be a somewhat different pattern among men women for deaths due to accidents, poisonings, violence w.th tt* number of deaths somewhat low among men and high am1 women.
There were 39 cancer deaths among.nonwhite men, some** greater than expectation, although the numbers by site are small for meaningful analysis Mortality from cerebro*a*cl\ disease appeared high (PMR * 2,11) but the finding was bi"
upon only 19 deaths
Discussion
rbe I1
The present study was designed with two objectives ir ^
was to determine whether or not any angiosarcoma de*1*15
626
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xcurred among emplovees of the PVC fabricators under study, suet no angiosarcoma deaths were found among the employees 'tudied. the first question has an unequivocal answer A secondary obiective was that of examining the distribution of deaths by cause among the employees under study. Implicit in that obiective i the question of whether or not that distribution is, in some 'nse. unusual. There is no unequivocal answer to the latter Question Whether or not an observed distribution of causes of heath is unusual clearly relates to the standard or comparison Population as well as the analytic methodology.*
On the basis of a proportionate mortality analysis, there appear o he excesses in total cancer mortality among both white men *id white women in the study, when compared to the d'stributions of deaths for the total United States specific for color
sex and adjusted for age. Excesses in cancer mortality appear Wncentrated in cancers of the digestive system and, in particular, o cancers of the intestine for both men and women. In addition,
is a suggestion that mortality from cancer of the breast and "'inary organs among white women employees is higher than that <0f the total U.S. There are. however, several reasons why
***** of Occupational Medicine/Vol. 19, No. 9/September 1977
definitive interpretation is difficult It has. for example, been suggested that a Proportionate Mortality Ratio based on an exter nal population may not be sufficiently discriminating in screening for potential hazards/ In addition, an analysis using PMRs falls to take account of the absolute risk of dying in the population under study.6 Further, a number of studies have suggested an overall favorable mortality for industrial working populations, even in those where well-defined hazards increase risk for a specific cause.7 1 Factors such as these are meant to suggest that proportionate mortality analysis must be interpreted cautiously, with the intention of providing leads for further investigation.
Results consistent with those of previously published studies would be of particular interest. With no comparable working populations in the fabrication industry, potential contrasts may be found in studies of vinyl chloride workers Monson, et al, provided a proportionate mortality analysis of 161 deceased workers (all presumably white males) in two plants, one where vinyl chloride monomer is produced and one where it is polymerized into polyvinyl chloride.* Results of that study suggest a possible excess in total cancer mortality, primarily cancer of the
627
UCC 060551
liver However there was a suggestion that cancers of the lung and brain also appeared with excess frequency The current study, while suggesting an excess in total cancer, particularly digestive cancer, does not clearly point to marked excesses for cancers of the liver lung, and brain among white men, although the PMRs for these cancers are greater than one The observed-to-expected PMRs reported by Monson for vascular lesions affecting the cen tral nervous system, circulatory diseases, and external causes are similar to those reported here
Tabershaw and Caffey. in a study of workers engaged in the manufacture of vinyl chloride and its polymers, conclude that no specific cause of death was statistically significantly greater than expectations based upon Standardized Mortality Ratios (SMRsI using the U S male population as the standard * By other criteria, however, the authors conclude there may be an excess risk for mortality from digestive cancer, respiratory cancer, cancer of other and unspecified sites, and lymphomas At lower exposure levels, thev suggest some excess for cancers of the buccal cavity and cancers of the other and unspecified sites
The current study would seem to indicate that excesses of mor tality from cancer of the digestive system are not sex-specific and are not limited to liver cancer The maiority of the PMRs for cancer among both white men and white women are in excess of unity Such results must be interpreted with caution but. since they ap pear to be consistent with previously studied workers, they suggest the need for continued investigation.
Summary
Results of a study of 4 )41 deaths occurring among current and former employees of 17 PVC fabricators during the period 19641973 are presented. The study was carried out to determine whether any angiosarcoma deaths had occurred among em ployees of these fabricators and to examine the distribution of deaths by cause No angiosarcoma deaths were found among the study population. Distributions by cause of death among white male and white female employees were compared with those for
the entire L1 S. specific for color and sex and ad|usted for age bi
means of Proportionate Mortality Ratios There appears to be an important excess in total cancer mortality among both white mai* and while female employees with^gMto* MMer particular
(
that of the^QtiftiBe. contributing to the excess Among the women employees, cancers of the breast and urinary organs mai also be in excess. No excesses were found for diseases of the o culatory system. There were deficits in mortality from cirrhosis oi the liver among both male and female employees and a deficit m accidents, poisonings, and violence among men The use ot tly
Proportionate Mortality Ratio based on an external standard requires ^g^f^nterpreting these results, but the need for tut ther investigations is indicated.
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Thu studv was sponsored by the following organizations American Can Cwnpin, B F Goodrich Company. Diamond Shamrock Corporation Firestone Tre and Sutxw Company lohns ManviNe, Motor Ve+Kle Manufacturer* Association Siaur* Chemical Company union Carbide Corporate Unroyal Incorporated
Occ
Reference*
1 Sehkoff l| and Hammond EC 'Eds' Toxiotv of vmvl chloride -- polyvinyl chloride Ann V V Acad So 24b 1975
2 Manual of the International Classification of Diseases Adapted for I* m the United States Eighth Revision. Washington. DC U S Govt Pnnttnt Office. 1967 Vol 1.
3 National Center For Health Statistics Vital Statistics of the Umtrc States, 1968 * Volume II - Mortality, Part A Washington, DC., US Co*' Printing Office, 1972, pp 140-205.
4 Chiazze L Problems of study design and interpretation of industry mortality experience IOM 14 169-170. 1976.
5 Redmond CK and Bresim PP Comparison of methods for assessing a cupational hazards /OM 17-313-317 1975
6 Monson RR Peters |M and lohnson MN Proportional mortality amon* vinyl-chloride workers Lancer 2 397*398. 1974
7 Llovd JW and Ciocco A Long term mortality study of steelworkprMethodology /OM 11 299-310. 1969
8 Redmond OC, Ciocco A Uovd |W, and Rush HW Long term moru1' study of steelworkers IV Mortality from malignant neoplasms among oven workers /OM 14 621-629 1972
9 Tabershaw IR and Gaffev WR- Mortality study of workers m ** manufacture of vinyl chloride and its polymers /OVf 16 509*518 ^ i
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