Document 3QyXVoyKaQdy2oZ4ZX31p41Ya
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FINAL REPORT
Epidemiology, 220-6W-08 Medical Department 3M Company St. Paul, MN 55144
Date: July 16, 2012
Title: A Cohort Mortality Study of the 3M Cordova Facility (1970-2009)
Study Start Date: March 24, 2011
Protocol Number: EPI-0037 IRB Approval #: 11-022
IRB Approval Date: March 24, 2011
Principal Investigator: Co-investigators:
Kara L. Andres, MS1
Geary W. Olsen, D.V.M., Ph.D1 Betsy Buehrer, DO, MPH1 Ken H. Ramm, MS2 Rebecca L. Cox, BSN2 Matthew C. Nunnally, MS2
Study Director:
Carol Ley, M.D., M.P.H.1
1 Corporate Occupational Medicine, Medical Department, 3M Company, Mail Stop
220-6W-08, St. Paul, MN 55144 2 EHS&R, 3M Cordova, Cordova, IL 61242
Table of Contents
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Report Title Page ...............................................................................................................1 Table of Contents ...............................................................................................................2
1
ABSTRACT ................................................................................................3
2
INTRODUCTION......................................................................................7
3
METHODS .................................................................................................8
3.1
Cohort Definition and Identification........................................................8
3.2
Determination of Vital Status ...................................................................9
3.3
Data Analyses ...........................................................................................10
4
RESULTS .................................................................................................12
4.1
Cohort Demographics..............................................................................12
4.2
Standardized Mortality Ratios ...............................................................13
4.2.1
Entire Cohort..............................................................................................13
4.2.2
By Major Departments...............................................................................16
5
DISCUSSION ...........................................................................................19
6
REFERENCES .........................................................................................23
Listing of Tables...............................................................................................................24
Appendix.............................................................................................(follows the tables)
1. ABSTRACT
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The purpose of this epidemiologic research was to conduct a general retrospective
cohort mortality study of 3M's Cordova, Illinois facility. The plant began operations in
1970 and is administered by the 3M Materials Resource Division. 3M Cordova is a two-
factory facility consisting of Electronic Materials and Internal Materials manufacturing
that produces specialty chemicals, adhesives, and fluorinated chemicals for a variety of
3M internal customers as well as external customers.
Study eligibility was defined as those 3M employees who had at least 6
cumulative months of employment at the Cordova facility from January 1, 1970 through
December 31, 2008. The vital status of the cohort and the underlying cause of death
information were ascertained through the National Death Index (1979-2009). For this
study, all underlying causes of death were coded to the International Classification of
Diseases (ICD) revision that was in effect at the time the death occurred. An online
search of the Social Security Death Index was also conducted to identify any deaths that
occurred prior to 1979.
Cause-specific mortality experience was examined by calculating Standardized
Mortality Ratios (SMRs) and 95% confidence intervals (95% CIs) for 63 causes of death
using the Occupational Cohort Mortality Analysis Program (OCMAP-PLUS). Statistical
significance of a cause-specific SMR was defined as the exclusion of the null SMR value
(1.0) from the 95% CI. Expected deaths were calculated using white male and female
mortality rates from 1970 through 2007 for the United States as well as the combined
region of the state of Iowa plus 46 counties in Illinois whose southern border is the
Interstate 72 corridor, excluding the 9 county Chicagoland area. Although no specific
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exposure analyses were conducted, the mortality experience was stratified by 6 major departments at the Cordova facility: Building 1 (administration), electronics, internals, magnetic (mag) oxide, maintenance, and warehouse. Analyses examined those employees who "ever" or "only" worked in these major departments.
Based on the above study eligibility criteria, the Cordova cohort represented 931 employees, 752 (81%) males and 179 (19%) females, with 21,019.5 total person-years of follow-up. At the end of study, the vital status of the 931 cohort members was: 870 (93%) alive, 61 (7%) deceased, and 0 lost-to-follow-up. Of the 61 total observed deaths, 51 (84%) were male and 10 (16%) were female. Because of the relatively few females in this Cordova cohort and the small number of associated deaths, all statistical analyses that follow represent the aggregate observed and expected totals for males and females. Based on United States mortality rates, there were 93.9 expected deaths (SMR 0.65, 95% CI 0.50-0.84). Using regional mortality rates, there were 85.0 expected deaths (SMR 0.72, 95% CI 0.55-0.92). Because of the comparability of SMRs using United States and regional white mortality rates, subsequent mortality analyses only present the data using expected values calculated based on the latter.
There were no statistically significant increased SMRs for any specific cause of death categories in the no latency analysis. Of the 61 observed deaths, 18 were in the category of all malignant neoplasms (24.7 expected, SMR 0.73, 95% CI 0.43-1.15). Two specific anatomic cancer sites had more than 1 observed death: pancreas (3 observed, 1.3 expected, SMR 2.28, 95% CI 0.47-6.66); and lung (9 observed, 8.0 expected, SMR 1.13, 95% CI 0.52-2.14). There were 16 deaths from heart disease compared to 21.6 expected (SMR 0.74, 95% CI 0.42-1.20), of which the majority were related to ischemic heart
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disease (14 observed vs. 16.2 expected). Although not statistically significant, there were more observed deaths than expected for cirrhosis of the liver (5 observed, 2.0 expected, SMR 2.56, 95% CI 0.83-5.97). There were fewer than expected deaths for external causes (8 observed, 14.2 expected, SMR 0.57, 95% CI 0.24-1.11) with slightly fewer than expected deaths for accidents.
Analyses by 10, 15, and 20 year latency periods resulted in no substantive changes in SMRs, although cirrhosis of the liver became statistically significant at the 15 year latency period (5 observed, 1.4 expected, SMR 3.63, 95% CI 1.18-8.45).
In the analyses based on employees who "ever" worked in the 6 major departments, the only statistically significantly elevated SMR occurred in Building 1 for cirrhosis of the liver (3 observed, 0.6 expected, SMR 5.01, 95% CI 1.03-14.64); however, this SMR was highly imprecise as seen by its wide confidence interval. There were no significantly increased SMRs for any causes of death among employees who "only" worked in the major departments (Building 1, internals, and maintenance were analyzed).
Cirrhosis of the liver represents a late stage of chronic liver disease resulting in progressive hepatic fibrosis characterized by distortion of the hepatic architecture and the formation of regenerative nodules. The 2 most common causes for cirrhosis of the liver are alcohol consumption and hepatitis C infection. Another common cause is nonalcoholic steatohepatitis (NASH). The major feature in NASH is fat in the liver that results in hepatic inflammation. Individuals with NASH do not have a significant history of alcohol consumption (Schuppan and Afdhal 2008).
For the 5 employees who died from cirrhosis of the liver, information obtained from both death certificates and archived 3M medical record review showed that 3 of the
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5 were known heavy users of alcohol. The remaining two people had sparse information with no known risk factors identified.
Based on the results from this study, we offer the following recommendations: 1) communicate the study results to 3M Cordova employees; 2) provide information to employees on cirrhosis of the liver including known risk factors; 3) conduct an update of this mortality study in approximately 5 years; 4) have Corporate Occupational Medicine (COM) nurses and physician continue monitoring for causes of liver disease, abnormal liver chemistry tests, alcohol consumption, elevated glucose, abnormal lipids, and elevated body mass index for employees participating in annual Cordova HAZWOPER medical surveillance; and 5) promote employee participation in health risk appraisal and biometric screening programs when offered at the Cordova facility.
2. INTRODUCTION
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A general retrospective cohort mortality study is often proposed as a means to
initially examine the long-term health of an occupational workforce. These analyses are
not designed to be exposure (chemical)-specific studies. They do, however, examine the
mortality experience of the worker population by major production departments that are
identified via the abstraction and computerization of the employees' work history records.
Exposure-specific retrospective cohort mortality or nested case-control studies can
subsequently be conducted based on the findings of a general retrospective cohort
mortality study. An important aspect of occupational retrospective cohort mortality
studies, whether they are general or exposure-specific research endeavors, is the fact that
death registration in the United States is complete and has good specificity and sensitivity
for those cancers with poor survival (e.g., lung, stomach, liver, and pancreas). These
studies have limited inference for those disease outcomes with good survival
probabilities.
3M Corporate Occupational Medicine (COM) has sponsored several cohort
mortality studies over the past 25 years. Studies have been conducted at the St. Paul
plant (tape and abrasives), Nevada (commercial graphics), the Industrial Mineral plants
(Belle Mead, Corona, Little Rock, and Wausau), Cottage Grove, and Decatur (film and
chemicals). The latter 2 studies focused on experience related to perfluorochemicals
(Lundin et al. 2009; Alexander et al. 2003; Alexander and Olsen 2007).
The purpose of the present study was to conduct a general retrospective mortality
experience of 3M's Cordova, Illinois facility. This manufacturing plant began operations
in 1970 (see Appendix Table 1). It is currently administered by the 3M Materials
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Resource Division. 3M Cordova is a chemical manufacturing facility that produces specialty chemicals, adhesives, and fluorinated chemicals for a variety of 3M internal customers as well as external customers. It is a two-factory facility consisting of Electronic Materials and Internal Materials manufacturing that blends, reacts, and purifies hundreds of products utilizing many different technologies. The Internal Materials factory produces acrylate monomers and solid and liquid epoxy resins. The Electronic Materials factory produces 3M Novec TM Engineered Fluids, 3M Novec TM 1230 Fire Protection Fluid, specialty gases, and battery electrolytes. Internal Materials utilizes solvent, water based, and solid adhesive production technologies while Electronic Materials focuses on fluorination technologies.
More specific information regarding Cordova's highest used raw materials, top products, and significant changes or trends in materials by focus factory over the years is provided in Appendix Table 2. Although no specific exposure analyses were conducted in this study, the mortality experience by major departments, identified through a work history computerization process, was performed.
3. METHODS 3.1 Cohort Definition and Identification
All current and former 3M Cordova employees who had at least 6 cumulative months of employment at the Cordova facility between its inception (January 1, 1970) and December 31, 2008 were eligible for inclusion into the study.
The study cohort was identified through the use of multiple 3M record sources including: (1) Kardex (currently known as Kardex Remstar) files located in Cordova's
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human resource department; (2) the Human Resource Information System (HRIS), which covered the 1975 to 2000 time period; and (3) the company's current human resource record database (PeopleSoftTM). An ExcelTM job history file of employees who ever worked at the Cordova facility was provided to COM from the 3M Human Resources Department. A total of 1,394 Cordova employees were found in this job history file. Using these company record sources, COM staff abstracted demographic and work history information and entered it into a SAS (Version 9.1, Cary, NC) database. This resulted in a single Cordova work history database consisting of each employee's entire job history (kardex, HRIS, and PeopleSoftTM) in chronological order through December 31, 2008. The final Cordova work history database contained records for 1,392 employees (2 employees in the ExcelTM job history file were not included because they started working at the facility after 12/31/2008). Numerous quality assurance checks were performed throughout the data abstraction and entry process.
3.2 Determination of Vital Status An agreement with the National Death Index (NDI) of the National Center for
Health Statistics was approved in order to identify all eligible employee deaths and their underlying causes as listed on the death certificate. NDI Plus is a computerized database that allows for record linkage of study cohorts to identify deaths that have occurred since January 1, 1979 along with their underlying and contributing International Classification of Diseases (ICD) codes recorded on the death certificate. The ICD codes used in NDI Plus were revision 9 (ICD9) for deaths occurring prior to 1999 and revision 10 (ICD10) for deaths occurring in 1999 and onward. To identify any deaths prior to 1979, an online
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search of the Social Security Death Index (SSDI) was also conducted. As anticipated (since Cordova began production in 1970), all employee deaths in this study were identified through the NDI search. The cause of death was coded to "unknown" for any identified death with an unknown underlying cause. Vital status was ascertained through December 31, 2009.
3.3 Data Analyses The mortality experience was examined by calculating Standardized Mortality
Ratios (SMRs) and 95% confidence intervals (95% CIs) for 63 causes of death using the Occupational Cohort Mortality Analysis Program (OCMAP-Plus). The SMR is the ratio of the observed number of deaths (identified by NDI and SSDI searches) divided by the expected number of deaths for the study cohort. Person-years were accumulated across 5-year age-specific and calendar-year-specific categories from the date of entry into the cohort (beginning 6 months after the date of hire) until the earliest of the following events: (1) the employee died; (2) the employee was lost to follow-up; or (3) the employee was alive as of December 31, 2009. Subjects with unknown vital status were withdrawn from the analysis on the date of their last known work history date. Expected deaths among the study cohort were calculated by multiplying the race (assumed to be white)-, sex-, age-, and calendar year stratum-specific person-year estimates and mortality rates together, and then summing the products across strata.
External analyses were conducted using both the United States and region-specific mortality rates. The region-specific comparison population consisted of the entire state of Iowa plus 46 of the upper northern half of the counties in Illinois excluding the 9 county
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Chicagoland area (see Appendix Figure 1). Cause-, race-, sex-, age-, and time-specific mortality rates for the 1970-2007 time period were obtained from the Mortality and Population Data System (MPDS) at the University of Pittsburgh (Pittsburgh, PA). These mortality rates were unadjusted, which are appropriate to use for studies such as this where all the deaths being analyzed have been coded to the revision of the ICD that was in effect at the time of death (ICD9 or ICD10 for this study).
Statistical significance of a cause-specific SMR was defined as the exclusion of the null SMR value (1.0) from the 95% CI. SMRs were calculated when the number of observed deaths was greater than 0 and the expected value was 0.1 deaths or greater. However, SMR calculations based on less than 2 expected deaths can result in highly unstable estimates, as seen by the wide 95% CIs, thus caution should be exercised regarding any inferences based on these SMRs.
Stratified SMR estimates were calculated based on work in the following 6 major departments defined a priori: Building 1 (administration), electronics, internals, magnetic (mag) oxide, maintenance, and warehouse. The specific department codes used to define these 6 major departments categories can be found in Table 1. This categorization was done by 3M Cordova industrial hygienists (MCN, KHR) based on the Human Resource (HR) department code and the location where this department did the majority of its work. For example, for those HR electronic department codes assigned to the electronics department in Table 1, the primary location of work was in Building 20 and Building 30. Other HR electronic department codes were assigned to the Building 1 department in Table 1. These analyses classified cohort members' work experience as "ever" or "only" worked in these 6 major departments. "Ever" analyses for a specific department included
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all employees who worked in the department at some point during their Cordova work history experience (regardless of whether they worked in another major department as well). "Only" analyses for a specific department included all employees who only worked in the 1 specified department during their entire Cordova work experience. SMR estimates were not calculated for those "only" analyses for departments with a small number of employees (i.e. electronics, mag oxide, and warehouse) due to the lack of precision of the risk calculations. Within these major department classifications, analyses by years worked and latency intervals were also conducted for selected causes of death that were of interest based on the initial overall cohort analyses.
4. RESULTS 4.1 Cohort Demographics
A total of 931 employees met the study eligibility criteria of having worked for 6 cumulative months or longer at the Cordova facility. There were 752 (81%) males and 179 (19%) females. Altogether, the cohort represented 21,019.5 person-years of follow-up, with males having 17,161.9 person-years (82%) and females having 3,857.6 person-years (18%). The earliest hire date for any individual was June 22, 1970; therefore, the earliest start date of follow-up was December 22, 1970 (hire date + 6 months). The latest possible stop date of follow-up was December 31, 2009 (end of study date).
As shown in Table 2, at end of study there were 870 (93%) cohort members alive, 61 (7%) deceased, and 0 lost-to-follow-up. The 870 individuals considered alive included 406 individuals who were not deceased by end of study and had a last work
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history date of December 31, 2008. Of the 61 deceased individuals, the underlying cause of death was identified for 60 (98%). There were 51 (84%) male deaths and 10 (16%) female deaths.
The distribution of study subjects by age at hire, age at entry into follow-up, and age at death for males and females is presented in Table 3. For males, the average age at hire was 29 and the average age at death was 57. These values were similar for females, 28 and 59, respectively.
Presented in Table 4 is the distribution of the number of male and female employees and their person-years by age group. The distribution of the number of male and female employees and their person-years by calendar year is shown in Table 5. The number of cohort members who "ever" and "only" worked in the 6 major departments along with the number of deaths and person-years is presented in Table 6. Internals was the largest department by number of employees who "ever" worked and by "ever" person-years.
4.2 Standardized Mortality Ratios 4.2.1 Entire Cohort
Table 7 provides the observed and expected deaths, SMRs, and 95% CIs for selected causes of death using United States white mortality rates for the calculation of expected values. The 21 causes of death listed were those that had 1 or more observed deaths based on a no latency analysis. Among the 931 cohort members, there were 61 total observed deaths compared to 93.9 expected deaths (SMR 0.65, 95% CI 0.50-0.84). This SMR was statistically significantly below the null value of 1.0. Also statistically
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significantly lower than expected, was the number of deaths for the category of external causes (8 observed, 17.2 expected, SMR 0.47, 95% CI 0.20-0.92).
Of the 61 total deaths, 54 had an underlying cause that was classified into one of the specific cause of death categories displayed in Table 7 and 1 had an unknown underlying cause that displays as `unknown causes'. The remaining 6 deaths (4 males and 2 females) had underlying causes that were included in the OCMAP-Plus nonspecific category of `all other causes'. This nonspecific category was not included in the tables. A review of these 6 deaths (12.1 expected, SMR 0.50, 95% CI 0.18-1.08) found the following underlying causes of death according to ICD9 (numeric) or ICD10 (alphanumeric): 335.2, motor neuron disease; 557.0, acute vascular insufficiency of intestine; 578.9, hemorrhage of gastrointestinal tract, unspecified; A41.9, septicemia, unspecified; B18.2, chronic viral hepatitis C; and G90.9, disorder of autonomic nervous system, unspecified.
The 10 female deaths occurred in the following cause of death categories: 1 death each for esophageal cancer (< 0.1 expected), breast cancer (0.8 expected), other (not defined) malignant neoplasms (0.3 expected), non-malignant respiratory disease (0.8 expected), cirrhosis of the liver (0.2 expected), and motor vehicle accidents (0.4 expected); and 2 deaths each for ischemic heart disease (1.2 expected) and other (see explanation above) causes (1.6 expected). Because of the relatively few females in this Cordova cohort and the small number of associated deaths, all statistical analyses that follow represent the aggregate observed and expected totals for males and females.
Table 8 provides the observed and expected deaths, SMRs, and 95% CIs for the same 21 causes of death using the regional white mortality rates for the calculation of expected values for 4 latency periods (0, 10, 15 and 20 years). In the no latency analysis,
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the SMR of 0.72 (61 observed, 85.0 expected, CI 0.55-0.92) for all causes was slightly higher than that using the United States as the comparison group (SMR=0.65), but was also statistically significantly below the null value. The difference in these SMRs was due to 8.9 fewer expected deaths using the regional mortality rates. Because the use of region-specific rather than national rates for external comparisons may more accurately reflect the expected mortality experience, subsequent analyses present the data using expected values calculated based on regional mortality rates.
There were no statistically significantly elevated SMRs for any specific cause of death category in the no latency analysis in Table 8. Of the 61 observed deaths, 18 were in the category of all malignant neoplasms (24.7 expected, SMR 0.73, 95% CI 0.43-1.15). Two specific anatomic cancer sites had more than 1 observed death: pancreas (3 observed, 1.3 expected, SMR 2.28, 95% CI 0.47-6.66); and lung (9 observed, 8.0 expected, SMR 1.13, 95% CI 0.52-2.14). There were 16 deaths from heart disease compared to 21.6 expected (SMR 0.74, 95% CI 0.42-1.20), of which the majority were related to ischemic heart disease (14 observed vs. 16.2 expected). Although not statistically significant, there were more observed deaths than expected for cirrhosis of the liver (5 observed, 2.0 expected, SMR 2.56, 95% CI 0.83-5.97). There were fewer than expected deaths for external causes (8 observed, 14.2 expected, SMR 0.57, 95% CI 0.24-1.11) with slightly fewer than expected deaths for accidents (8 observed vs. 9.1 expected).
Analyses by 10, 15, and 20 year latency periods resulted in SMRs for all malignant neoplasms (0.73, 0.68, 0.57, respectively) that were similar to that from the no latency analysis (SMR=0.73) (Table 8). The SMRs for pancreatic cancer remained nonsignificantly elevated with fairly imprecise confidence intervals across these latency
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periods at 1.68 (95% CI 0.20-6.09), 1.87 (95% CI 0.23-6.76), and 1.12 (95% CI 0.03-6.22), respectively. SMRs for lung cancer also remained nonstatistically significant at 1.24 (95% CI 0.57-2.35), 1.08 (95% CI 0.43-2.22), and 0.93 (95% CI 0.30-2.16). SMRs for heart disease remained below the null value (0.75, 0.86, 0.91) for the 10, 15, and 20 year latency periods, respectively. Cirrhosis of the liver became statistically significant at the 15 year latency period (SMR 3.63, 95% CI 1.18-8.45), and was nonsignificantly increased at the 10 year (SMR 3.08, 95% CI 1.00-7.18) and 20 year (SMR 2.76, 95% CI 0.57-8.06) latency period analyses.
4.2.2 By Major Departments Table 9 provides the observed and expected deaths, SMRs, and 95% CIs for the 21
cause of death categories for employees who "ever" worked in the 6 major departments assuming no latency period. By definition of "ever", cohort members may have worked in more than 1 of these departments. The only statistically significantly increased SMR was for cirrhosis of the liver in Building 1 (3 observed, 0.6 expected, SMR 5.01, 95% CI 1.03-14.64). This SMR was also increased, although nonsignificantly, in the internals department (3 observed, 1.0 expected, SMR 2.94, 95% CI 0.61-8.58). Also, observed deaths for pancreatic cancer (n=2) were nonsignificantly greater than expected in the internals (0.6 expected) and warehouse (0.3 expected) departments, and for lung cancer the same was true in the internals (5 observed vs. 3.1 expected), maintenance (5 observed vs. 3.5 expected), and warehouse (3 observed vs. 1.7 expected) departments. There were no observed deaths for those who "ever" worked in the electronics department (as defined in Table 1), but the data are displayed to show the expected number of deaths. Overall,
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there were statistically significantly fewer deaths than expected (26 observed, 38.3 expected, SMR 0.68, 95% CI 0.44-1.00) among employees who "ever" worked in internals.
Table 10 provides the observed and expected deaths, SMRs, and 95% CIs for the cause of death categories for employees who "only" worked in the Building 1, internals, or maintenance major departments assuming no latency period. "Only" SMR estimates were not calculated for the electronics, mag oxide, and warehouse departments due to the small number of employees. There were no significantly increased SMRs for any causes of death; however, observed deaths were greater than expected for lung cancer in the internals (2 observed vs. 0.7 expected) and maintenance (3 observed vs. 1.8 expected) departments. There was only 1 death each in Building 1 and internals for cirrhosis of the liver and no pancreatic cancer deaths.
Tables 11-15 provide a summary of observed versus expected number of deaths for all malignant neoplasms (Table 11), pancreatic cancer (Table 12), lung cancer (Table 13), heart disease (Table 14), and cirrhosis of the liver (Table 15) for all jobs (whole cohort) as well as for each major job department. The data are stratified by years worked (< 5 years, 5-14 years, 15-24 years, and 25 years) and latency (< 10 years, 10-19 years, and 20 years). Electronics is not included in these tables since there were no observed deaths among employees who worked in this department.
The 18 employees who died from all malignant neoplasms "ever" worked in Building 1, internals, mag oxide, maintenance, and warehouse departments (Table 11). In each of these departments, the total number of observed deaths was always less than the number expected.
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As seen from Table 12 under all jobs, there was 1 pancreatic cancer death for an employee who worked at Cordova for less than 5 years that had a latency of at least 20 years (i.e. the death occurred 20 or more years after the hire date). Another employee who worked at Cordova between 5 and 14 years died from pancreatic cancer within 9 years of hire, and the third pancreatic death for an employee who worked between 15 and 24 years occurred between 10 and 19 years after hire. These 3 employees "ever" worked in Building 1, internals, mag oxide, and warehouse departments. When summed over years worked, the ratio of observed versus expected deaths was statistically significant in the mag oxide (latency of < 10 years) and warehouse (latency of 10-19 years) departments.
The 9 employees who died from lung cancer "ever" worked in Building 1, internals, maintenance, and warehouse departments (Table 13). Four of these deaths occurred between 10 and 19 years after hire date and 5 deaths occurred 20 or more years after hire. Overall, in the internals, maintenance, and warehouse departments, the total number of observed lung cancer deaths was nonsignificantly more than the number of expected deaths.
Table 14 shows that the 16 employees who died from heart disease "ever" worked in Building 1, internals, maintenance, and warehouse departments. In each of these departments, the total number of observed deaths was less than the number expected.
As presented in Table 15, there was 1 employee who worked at Cordova for less than 5 years and 1 employee who worked between 5 and 14 years that died from cirrhosis of the liver between 10 and 19 years after their hire date. The other 3 cirrhosis of the
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liver deaths occurred 20 or more years after hire for 1 employee who worked at Cordova less than 5 years, 1 employee who worked between 15 and 24 years, and 1 employee who worked for 25 years or more. These 5 employees "ever" worked in Building 1, internals, maintenance, and warehouse departments. In each of these departments, the number of observed cirrhosis of the liver deaths was higher than expected, with the overall ratio being statistically significant in the Building 1 department.
5. DISCUSSION This general retrospective cohort study for the Cordova facility examined the
mortality experience of employees who worked 6 months or longer from 1970 through 2008. A total of 931 employees met these eligibility criteria. The overall results of this study showed nearly 30% less observed deaths than expected based on regional mortality rates. A similar overall deficit was observed for deaths from malignant neoplasms, heart disease, and nonmalignant respiratory disease. These findings were not unexpected and likely the result of the healthy worker effect.
The healthy worker effect is most often manifested in cohort studies of relatively young, healthy working populations. In this study, the mean age at hire was 29 for males (28 for females) and the mean age at death was 57 for males (59 for females). Therefore, this cohort was young (and healthy) compared to the national and regional comparison populations used to calculate the external expected values for the SMR analyses. The healthy worker effect is commonly observed in occupational cohort mortality studies because relatively healthy individuals are more likely to secure employment and remain employed than the average person in the general population. In a cohort mortality study,
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the healthy worker effect has been viewed both as a confounding factor as well as a selection bias (Checkoway et al. 2004). Three major aspects of the healthy worker effect include: 1) the selection of healthy persons into employment; 2) the self-selection of unhealthy persons out of the workforce (also referred to as the healthy survivor effect); and 3) the length of follow-up time of the cohort.
Cirrhosis of the liver was the only cause of death that was statistically significantly elevated. Cirrhosis of the liver represents a late stage of chronic liver disease resulting in progressive hepatic fibrosis characterized by distortion of the hepatic architecture and the formation of regenerative nodules (Schuppan and Afdhal 2008). Overall a total of 5 deaths were observed compared to 2.0 expected that became statistically significant with a 15 year latency analysis (5 observed, 1.4 expected, SMR 3.63, 95% CI 1.18-8.45). From a department standpoint, 3 of these individuals "ever" worked in Building 1, 3 "ever" worked in internals, and 1 each "ever" worked in maintenance and warehouse. Two individuals had "only" worked in their departments of Building 1 and internals. Potential exposure information specific to these individuals was unknown.
The 2 most common causes for cirrhosis of the liver are alcohol consumption and hepatitis C infection. Other causes of cirrhosis include autoimmune inflammation of the liver, disorders of the drainage system of the liver, such as primary biliary cirrhosis and primary sclerosing cholangitis, hepatitis B infection, metabolic disorders of iron (hemochromatosis) and copper (Wilson's disease), medications, environmental and occupational exposure to hepatoxins, and non-alcoholic steatohepatitis (NASH) which is a form of non-alcoholic fatty liver disease (NAFLD) (Schuppan and Afdhal 2008).
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The major feature in NASH is fat in the liver. Liver inflammation and damage occurs in NASH. Individuals with NASH do not have a significant history of alcohol consumption. Individuals with NASH have liver biopsy findings indistinguishable from alcoholic steatohepatitis. NASH and NAFLD are frequently associated with obesity, type 2 diabetes mellitus, and hyperlipidemia. After hepatitis C virus was identified in 1989 and non-alcoholic steatohepatitis in obese individuals with diabetes, the diagnosis of liver cirrhosis without a cause is rarely made (Schuppan and Afdhal 2008).
Information regarding causes for the 5 cirrhosis of the liver deaths in this study was obtained by review of the death certificates and archived 3M medical records. The latter included data from 2 Cordova medical surveillance programs: chemical and HAZWOPER (definition below) medical surveillance. The chemical medical surveillance program was not specific to any occupational exposure. The Occupational Safety and Health Administration (OSHA) enacted 29CFR 1910.120 Hazardous Waste Operations and Emergency Response (HAZWOPER) in March 1990. Components of these medical surveillance programs include medical history, occupational history, health habits including alcohol consumption, physical examination, and a battery of blood chemistry tests including liver transaminases, lipid panel and glucose. Employees with abnormal liver chemistry tests are advised to follow up with their personal physician.
For the 5 employees who died from cirrhosis of the liver, information obtained from both death certificates and archived 3M medical record review showed that 3 of the 5 were known heavy users of alcohol (Table 16). The remaining two people had sparse information with no known risk factors identified.
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There are methodological strengths in this Cordova cohort study. These include: 1) the vital status of all 931 cohort members was ascertained (0 were lost-to-follow-up); 2) the high percentage (98%) of the cohort whose underlying cause of death was determined; and 3) the use of regional and national mortality rates in the external population comparisons.
As with other cohort mortality investigations, the present study lacked information about cigarette smoking. Smoking history is an important confounder needed in the investigation of nonmalignant respiratory diseases and lung cancer. However, the SMRs in this study for these causes of death were not significantly increased. The other major limitation in this study was the lack of exposure-specific information. As this investigation was designed to be a general mortality study, such information was not collected a priori.
Based on the results from this study, we offer the following recommendations: 1) communicate the study results to 3M Cordova employees; 2) provide information to employees on cirrhosis of the liver including known risk factors; 3) conduct an update of this mortality study in approximately 5 years; 4) have COM nurses and physician continue monitoring for causes of liver disease, abnormal liver chemistry tests, alcohol consumption, elevated glucose, abnormal lipids, and elevated body mass index for employees participating in annual Cordova HAZWOPER medical surveillance; and 5) promote employee participation in health risk appraisal and biometric screening programs when offered at the Cordova facility.
6. REFERENCES
3M Company EPI-0037
Page 23 of 25
Alexander BH, Olsen GW, Burris JM, Mandel JH, Mandel JS. (2003) Mortality of employees of a perfluorooctanesulphonyl fluoride manufacturing facility. Occup Environ Med 60:722-729.
Alexander BH, Olsen GW. (2007) Bladder cancer in perfluorooctanesulfonyl fluoride manufacturing workers. Annals Epidemiol 17:471-478.
Checkoway H, Pearce N, Kreibel D. (2004) Cohort studies. (In) Research Methods in Occupational Epidemiology. Second Edition. New York, NY:Oxford University Press.
Lundin JI, Alexander BH, Olsen GW, Church TR. (2009) Ammonium perfluorooctanoate production and occupational mortality. Epidemiology 20:921-928.
Schuppan D, Afdhal N. (2008) Liver cirrhosis. Lancet 317:838-851.
3M Company EPI-0037
Page 24 of 25
Listing of Tables
Table 1. Specific Department Codes Included in Each Major Department Categorization
Table 2. Distribution of Cordova Cohort by Vital Status at End of Study (12/31/2009)
Table 3. Distribution of Age at Hire, Age at Entry into Follow-up, and Age at Death by Age Group and Sex for Cordova Cohort
Table 4. Distribution of the Number of Employees and Person-years by Age Group and Sex for Cordova Cohort
Table 5. Distribution of the Number of Employees and Person-years by Calendar Year and Sex for Cordova Cohort
Table 6. Distribution of the Number of Employees, Number of Deaths, and Personyears by Major Department for Cordova Cohort
Table 7.
Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death for the Cordova Cohort, Using United States White Mortality Rates for Expected Deaths, No Latency Period
Table 8.
Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death for the Cordova Cohort, by Latency Period, Using Regional White Mortality Rates for Expected Deaths
Table 9.
Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death by Employees Who Ever Worked in the Major Departments, Using Regional White Mortality Rates for Expected Deaths, No Latency Period
Table 10.
Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death by Employees Who Only Worked in Building 1, Internals, and Maintenance, Using Regional White Mortality Rates for Expected Deaths, No Latency Period
Table 11. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for All Malignant Neoplasms
Table 12.
3M Company EPI-0037
Page 25 of 25
Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Cancer of Pancreas
Table 13. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Cancer of Lung
Table 14. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Heart Disease
Table 15. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Cirrhosis of Liver
Table 16. Risk Factor Information for 5 Cirrhosis of the Liver Deaths
Table 1. Specific Department Codes Included in Each Major Department Categorization
Building 1
37
7914
225
7915
291
7921
311
7946
390
7956
795
8038
1299
51080
4293
79014
4294
108110
5104
108115
5108
108120
5900
108125
6821
108130
6825
108162
6840
108164
6844
401310
6850
430030
6853
430040
6854
431040
7294
431047
7390
431056
7604
600400
7904
610180
7905
803042
7907
816420
7910
819180
7912
822481
7913
826060
850020
Electronics 7920 7923 7960
108020 108022 108060 108061 108069 108160 108184
Internals 7930 7940 7945 7955
108045 108055 108145 108183
Mag Oxide 5101 5102 5105 5107 5250 5515 5516 5517 5518 5519 5520
108001 108017 108105
Maintenance 5106 7708 7808 7901 7902 7903 7908 7918
108100 108170 108175 108180 108185 108717
Warehouse 7906 7911 7939 9706
108140
Table 2. Distribution of Cordova Cohort by Vital Status at End of Study (12/31/2009)
Vital Status Alive Died while employed Deceased while terminated or retired Unknown Total
Cause of Death Identified
N
Percent
Yes
No
870
93.4
-
-
10
1.1
10
0
51
5.5
50
1
0
0.0
931
100.0
-
-
60
1
Table 3. Distribution of Age at Hire, Age at Entry into Follow-up, and Age at Death by Age Group and Sex for Cordova Cohort
Age Group <20
20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79
80 Total a
Number (%) of Males Age at Entry
Age at Hire Into Follow-up
86 (11)
62 (8)
212 (28) 218 (29)
172 (23) 178 (24)
111 (15) 111 (15)
82 (11)
90 (12)
49 (7)
48 (6)
22 (3)
27 (4)
16 (2)
16 (2)
2 (0)
2 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0) 752 (100)
0 (0) 752 (100)
Age at Death 0 (0) 0 (0) 1 (2) 2 (4) 0 (0) 6 (12) 4 (8) 9 (18) 7 (14) 11 (22) 5 (10) 3 (6) 3 (6) 0 (0) 51 (100)
Average Age
29
30
57
a Total percents were based on non-rounded values.
Number (%) of Females
Age at Entry
Age at Hire
Into Follow-up
Age at Death
33 (18)
32 (18)
0 (0)
52 (29)
48 (27)
0 (0)
40 (22)
42 (24)
1 (10)
21 (12)
20 (11)
0 (0)
13 (7)
15 (8)
0 (0)
10 (6)
10 (6)
0 (0)
4 (2)
6 (3)
1 (10)
5 (3)
5 (3)
1 (10)
0 (0)
0 (0)
2 (20)
1 (1)
1 (1)
1 (10)
0 (0)
0 (0)
1 (10)
0 (0)
0 (0)
2 (20)
0 (0)
0 (0)
1 (10)
0 (0) 179 (100)
0 (0) 179 (100)
0 (0) 10 (100)
28
28
59
Table 4. Distribution of the Number of Employees and Person-years by Age Group and Sex for Cordova Cohort
Age Group <20
20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80 Totala
Males
N
Person-yrs
62
44.6
280
828.5
452
1,798.4
543
2,351.7
593
2,631.1
579
2,617.6
552
2,447.0
460
1,894.6
318
1,329.6
201
654.2
88
328.8
45
144.0
17
63.5
10
28.3
---
17,161.9
a Total person-yrs were based on non-rounded values.
Females
N
Person-yrs
32
38.2
80
262.2
120
452.7
123
542.1
128
589.4
128
570.4
120
545.7
100
401.1
65
221.3
29
103.9
13
58.3
11
38.1
5
22.2
5
11.9
---
3,857.6
Total
N
Person-yrs
94
82.8
360
1,090.7
572
2,251.1
666
2,893.8
721
3,220.5
707
3,188.0
672
2,992.7
560
2,295.7
383
1,550.9
230
758.1
101
387.1
56
182.1
22
85.7
15
40.2
---
21,019.5
Table 5. Distribution of the Number of Employees and Person-years by Calendar Year and Sex for Cordova Cohort
Calendar Year
Males
N
Person-yrs
1970-1974
74
126.9
1975-1979
329
1,203.8
1980-1984
432
1,925.8
1985-1989
469
2,208.6
1990-1994
505
2,425.3
1995-1999
612
2,719.6
2000-2004
657
3,141.4
2005-2009 Totala
720
3,410.5
---
17,161.9
a Total person-yrs were based on non-rounded values.
Females
N
Person-yrs
0
0.0
62
152.4
93
385.8
110
486.0
127
598.4
150
667.5
160
740.9
171
826.5
---
3,857.6
Total
N
Person-yrs
74
126.9
391
1,356.2
525
2,311.6
579
2,694.6
632
3,023.7
762
3,387.1
817
3,882.3
891
4237.0
---
21,019.5
Table 6. Distribution of the Number of Employees, Number of Deaths, and Person-years by Major Department for Cordova Cohort
Major Department Building 1 Electronics Internals Mag Oxide Maintenance Warehouse
Ever Worked In
N
# of Deaths Person-yrs
326
23
6,446.9
212
0
3,102.4
521
26
12,157.0
72
5
1,880.7
278
24
6,708.1
167
13
4,385.5
Only Worked In
N
# of Deaths Person-yrs
173
12
3,123.4
34
0
n/a
154
12
3,204.8
14
2
n/a
96
11
2,346.5
13
2
n/a
n/a=Not applicable. Due to small numbers, "only" analyses were not done for these departments.
Table 7. Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death for the Cordova Cohort, Using United States White Mortality Rates for Expected Deaths, No Latency Period
Cause of Death All causes All malignant neoplasms
Esophagus Pancreas Lung Breast Central nervous system All lymphatic & hematopoietic
Leukemia Other malignant neoplasms Cerebrovascular dis. All heart disease Ischemic heart dis. Nonmalignant respiratory disease Bronchitis, emphysema & asthma Cirrhosis of liver Nephritis & nephrosis All external causes of death Accidents
Motor vehicle Other accidents Unknown causes
* p 0.05; **p 0.01
Obs
Exp
61
93.9
18
24.5
1
0.9
3
1.3
9
7.7
1
0.8
1
1.0
1
2.6
1
1.0
2
2.2
2
2.9
16
22.4
14
16.1
4
5.3
3
2.5
5
3.0
1
0.8
8
17.2
8
10.1
6
5.2
2
5.0
1
SMR 0.65** 0.73
1.17 2.27 1.17 1.22 0.98
0.39
1.02 0.92
0.68 0.71 0.87 0.75
1.19
1.66 1.18 0.47*
0.79 1.16 0.40
95% CI 0.50 - 0.84 0.44 - 1.16
0.03 - 6.53 0.47 - 6.62 0.54 - 2.23 0.03 - 6.82 0.02 - 5.46
0.01 - 2.16
0.03 - 5.68 0.11 - 3.33
0.08 - 2.47 0.41 - 1.16 0.47 - 1.46 0.20 - 1.92
0.25 - 3.47
0.54 - 3.88 0.03 - 6.60 0.20 - 0.92
0.34 - 1.55 0.43 - 2.52 0.05 - 1.45
Table 8. Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death for the Cordova Cohort, by Latency Period, Using Regional White Mortality Rates for Expected Deaths
Cause of Death
Obs
All causes
61
All malignant
18
neoplasms
Esophagus
1
Pancreas
3
Lung
9
Breast
1
Central nervous 1 system
All lymphatic & 1 hematopoietic
Leukemia
1
Other malignant 2 neoplasms
Cerebrovascular dis. 2
All heart disease 16
Ischemic heart dis. 14
Nonmalignant
4
respiratory disease
Bronchitis,
3
emphysema &
asthma
Cirrhosis of liver
5
Nephritis & nephrosis 1
All external
8
causes of death
Accidents
8
Motor vehicle 6
Other accidents 2
Unknown causes
1
* p 0.05; **p 0.01
No Latency
Exp
SMR
85.0
0.72**
24.7
0.73
95% CI 0.55 - 0.92 0.43 - 1.15
0.9
1.05
0.03 - 5.87
1.3
2.28
0.47 - 6.66
8.0
1.13
0.52 - 2.14
0.8
1.26
0.03 - 7.00
1.1
0.91
0.02 - 5.05
2.6
0.38
0.01 - 2.13
1.0
0.99
0.03 - 5.51
2.0
1.02
0.12 - 3.69
2.8
0.72
0.09 - 2.59
21.6
0.74
0.42 - 1.20
16.2
0.87
0.47 - 1.45
5.5
0.73
0.20 - 1.88
2.7
1.09
0.23 - 3.19
2.0
2.56
0.83 - 5.97
0.7
1.52
0.04 - 8.49
14.2
0.57
0.24 - 1.11
9.1
0.88
0.38 - 1.74
5.1
1.17
0.43 - 2.55
3.9
0.51
0.06 - 1.84
10 Year Latency
Obs
Exp
SMR 95% CI
54
69.9
0.77
0.58 - 1.01
16
21.8
0.73
0.42 - 1.19
1
0.9
1.14
0.03 - 6.37
2
1.2
1.68
0.20 - 6.09
9
7.3
1.24
0.57 - 2.35
1
0.6
1.54
0.04 - 8.60
1
0.9
1.13
0.03 - 6.27
0
2.2
---
0.00 - 1.70
0
0.8
---
0.00 - 4.47
2
1.7
1.16
0.14 - 4.18
2
2.5
0.81
0.10 - 2.94
14
18.7
0.75
0.41 - 1.25
12
14.1
0.85
0.44 - 1.49
4
5.0
0.80
0.22 - 2.06
3
2.6
1.15
0.24 - 3.36
5
1.6
3.08
1.00 - 7.18
1
0.6
1.68
0.04 - 9.34
6
8.2
0.73
0.27 - 1.59
6
5.1
1.18
0.43 - 2.57
4
2.6
1.55
0.42 - 3.96
2
2.5
0.80
0.10 - 2.88
1
15 Year Latency
Obs
Exp
SMR 95% CI
47
60.4
0.78
0.57 - 1.04
13
19.3
0.68
0.36 - 1.15
1
0.8
1.25
0.03 - 6.97
2
1.1
1.87
0.23 - 6.76
7
6.5
1.08
0.43 - 2.22
1
0.5
1.91
0.05 - 10.63
1
0.7
1.35
0.03 - 7.54
0
1.9
---
0.00 - 1.96
0
0.7
---
0.00 - 5.16
1
1.5
0.65
0.02 - 3.63
2
2.2
0.91
0.11 - 3.29
14
16.4
0.86
0.47 - 1.44
12
12.3
0.97
0.50 - 1.70
4
4.6
0.88
0.24 - 2.25
3
2.5
1.21
0.25 - 3.53
5
1.4
3.63* 1.18 - 8.45
1
0.5
1.82
0.05 - 10.16
4
6.0
0.67
0.18 - 1.71
4
3.7
1.07
0.29 - 2.75
2
1.8
1.11
0.13 - 4.00
2
1.9
1.04
0.13 - 3.76
0
20 Year Latency
Obs
Exp
SMR 95% CI
37
48.9
0.76
0.53 - 1.04
9
15.9
0.57
0.26 - 1.08
1
0.7
1.45
0.04 - 8.09
1
0.9
1.12
0.03 - 6.22
5
5.4
0.93
0.30 - 2.16
1
0.4
2.64
0.07 - 14.73
0
0.6
---
0.00 - 6.45
0
1.5
---
0.00 - 2.43
0
0.6
---
0.00 - 6.36
1
1.3
0.78
0.02 - 4.37
2
1.9
1.08
0.13 - 3.90
12
13.2
0.91
0.47 - 1.58
11
10.1
1.09
0.55 - 1.95
4
3.9
1.02
0.28 - 2.62
3
2.3
1.32
0.27 - 3.84
3
1.1
2.76
0.57 - 8.06
1
0.5
2.07
0.05 - 11.54
3
4.2
0.72
0.15 - 2.09
3
2.6
1.14
0.23 - 3.32
1
1.2
0.81
0.02 - 4.51
2
1.4
1.42
0.17 - 5.13
0
Table 9. Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death by Employees Who Ever Worked in the Major Departments, Using Regional White Mortality Rates for Expected Deaths, No Latency Period
Cause of Death All causes All malignant neoplasms
Esophagus Pancreas Lung Breast Central nervous system All lymphatic & hematopoietic
Leukemia Other malignant neoplasms Cerebrovascular dis. All heart disease Ischemic heart dis. Nonmalignant respiratory disease Bronchitis, emphysema & asthma Cirrhosis of liver Nephritis & nephrosis All external causes of death Accidents
Motor vehicle Other accidents Unknown causes
* p 0.05; **p 0.01
Building 1 Obs Exp SMR 95% CI
23
28.7 0.80 0.51 - 1.20
6
8.9 0.68 0.25 - 1.47
1
0.3 3.33 0.08 - 18.57
1
0.5 2.20 0.06 - 12.24
2
2.8 0.71 0.09 - 2.57
0
0.5
--- 0.00 - 7.62
0
0.4
--- 0.00 - 10.46
1
0.9 1.12 0.03 - 6.23
1
0.3 2.88 0.07 - 16.07
1
0.7 1.47 0.04 - 8.21
0
1.1
--- 0.00 - 3.47
7
7.3 0.96 0.38 - 1.97
6
5.5 1.10 0.40 - 2.40
2
2.1 0.95 0.12 - 3.45
2
1.1 1.87 0.23 - 6.76
3
0.6 5.01* 1.03 - 14.64
1
0.2 4.04 0.10 - 22.51
1
3.8 0.27 0.01 - 1.48
1
2.4 0.42 0.01 - 2.33
1
1.3 0.77 0.02 - 4.27
0
1.1
--- 0.00 - 3.39
0
Electronics Obs Exp SMR 95% CI
0
9.4
---** 0.00 - 0.39
0
2.4
--- 0.00 - 1.55
Internals Obs Exp SMR 95% CI
26
38.3 0.68* 0.44 - 1.00
8
10.2 0.79 0.34 - 1.55
0
0.1
--- 0.00 - 32.94
0
0.4
--- 0.00 - 8.52
0
0.1
--- 0.00 - 26.77
2
0.6 3.58 0.43 - 12.94
0
0.7
--- 0.00 - 5.02
5
3.1 1.60 0.52 - 3.73
0
0.0
--- 0.00 - 177.87
1
0.2 4.35 0.11 - 24.23
0
0.1
--- 0.00 - 26.35
0
0.6
--- 0.00 - 6.63
0
0.3
--- 0.00 - 14.16
0
1.1
--- 0.00 - 3.29
0
0.1
--- 0.00 - 36.88
0
0.4
--- 0.00 - 8.45
0
0.2
--- 0.00 - 17.64
0
0.8
--- 0.00 - 4.34
0
0.2
--- 0.00 - 16.00
2
1.0 1.98 0.24 - 7.15
0
2.2
--- 0.00 - 1.67
5
9.0 0.55 0.18 - 1.29
0
1.6
--- 0.00 - 2.26
4
6.7 0.60 0.16 - 1.53
0
0.4
--- 0.00 - 8.63
1
1.9 0.53 0.01 - 2.95
0
0.2
--- 0.00 - 16.93
1
0.9 1.07 0.03 - 5.98
0
0.3
--- 0.00 - 13.68
3
1.0 2.94 0.61 - 8.58
0
0.1
--- 0.00 - 58.42
0
0.3
--- 0.00 - 14.59
0
2.2
--- 0.00 - 1.65
4
8.7 0.46 0.13 - 1.17
0
1.4
--- 0.00 - 2.67
0
0.8
--- 0.00 - 4.74
0
0.6
--- 0.00 - 6.12
0
4
5.6 0.72 0.20 - 1.84
4
3.3 1.23 0.33 - 3.14
0
2.3
--- 0.00 - 1.60
1
Table 9. Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death by Employees Who Ever Worked in the Major Departments, Using Regional White Mortality Rates for Expected Deaths, No Latency Period
(Continued)
Cause of Death All causes All malignant neoplasms
Esophagus Pancreas Lung Breast Central nervous system All lymphatic & hematopoietic
Leukemia Other malignant neoplasms Cerebrovascular dis. All heart disease Ischemic heart dis. Nonmalignant respiratory disease Bronchitis, emphysema & asthma Cirrhosis of liver Nephritis & nephrosis All external causes of death Accidents
Motor vehicle Other accidents Unknown causes
* p 0.05; **p 0.01
Mag Oxide Obs Exp SMR 95% CI
5
10.5 0.48 0.16 - 1.12
2
3.3 0.61 0.07 - 2.19
0
0.1
--- 0.00 - 27.36
1
0.2 5.54 0.14 - 30.88
0
1.1
--- 0.00 - 3.29
0
0.1
--- 0.00 - 45.75
1
0.1 7.51 0.19 - 41.84
0
0.3
--- 0.00 - 10.96
0
0.1
--- 0.00 - 29.04
0
0.3
--- 0.00 - 14.28
0
0.4
--- 0.00 - 10.10
0
2.9
--- 0.00 - 1.29
0
2.2
--- 0.00 - 1.69
1
0.7 1.36 0.03 - 7.57
1
0.4 2.53 0.06 - 14.09
0
0.2
--- 0.00 - 15.59
0
0.1
--- 0.00 - 43.11
0
1.2
--- 0.00 - 3.04
0
0.8
--- 0.00 - 4.75
0
0.4
--- 0.00 - 8.95
0
0.4
--- 0.00 - 10.12
0
Maintenance Obs Exp SMR 95% CI
24
33.7 0.71 0.46 - 1.06
6
10.3 0.58 0.21 - 1.27
0
0.4
--- 0.00 - 8.87
0
0.6
--- 0.00 - 6.62
5
3.5 1.43 0.46 - 3.33
0
0.2
--- 0.00 - 17.30
0
0.4
--- 0.00 - 8.57
0
1.1
--- 0.00 - 3.46
0
0.4
--- 0.00 - 9.08
1
0.8 1.24 0.03 - 6.91
1
1.1 0.88 0.02 - 4.91
6
9.1 0.66 0.24 - 1.43
6
6.9 0.87 0.32 - 1.88
1
2.3 0.44 0.01 - 2.43
0
1.2
--- 0.00 - 3.16
1
0.8 1.28 0.03 - 7.16
1
0.3 3.79 0.10 - 21.11
5
4.6 1.10 0.36 - 2.56
5
2.9 1.72 0.56 - 4.01
3
1.6 1.90 0.39 - 5.54
2
1.3 1.50 0.18 - 5.43
0
Warehouse Obs Exp SMR 95% CI
13
17.9 0.73 0.39 - 1.24
5
5.3 0.95 0.31 - 2.21
0
0.2
--- 0.00 - 17.85
2
0.3 7.16 0.87 - 25.86
3
1.7 1.73 0.36 - 5.05
0
0.1
--
0.00 - 27.05
0
0.2
--- 0.00 - 15.58
0
0.6
--- 0.00 - 6.64
0
0.2
--- 0.00 - 17.10
0
0.4
--- 0.00 - 8.84
1
0.6 1.76 0.04 - 9.82
1
4.6 0.22 0.01 - 1.21
1
3.5 0.29 0.01 - 1.61
1
1.1 0.88 0.02 - 4.92
1
0.6 1.78 0.05 - 9.92
1
0.4 2.38 0.06 - 13.28
0
0.1
--- 0.00 - 27.66
4
3.0 1.35 0.37 - 3.46
4
1.9 2.10 0.57 - 5.39
3
1.1 2.78 0.57 - 8.12
1
0.8 1.22 0.03 - 6.78
0
Table 10. Observed (Obs) and Expected (Exp) Deaths, Standardized Mortality Ratios (SMRs), and 95% Confidence Intervals (CI) for Selected Causes of Death by Employees Who Only Worked in Building 1, Internals, and Maintenance, Using Regional White Mortality Rates for Expected Deaths, No Latency Period
Cause of Death All causes All malignant neoplasms
Esophagus Pancreas Lung Breast Central nervous system All lymphatic & hematopoietic
Leukemia Other malignant neoplasms Cerebrovascular dis. All heart disease Ischemic heart dis. Nonmalignant respiratory disease Bronchitis, emphysema & asthma Cirrhosis of liver Nephritis & nephrosis All external causes of death Accidents
Motor vehicle Other accidents Unknown causes
* p 0.05; **p 0.01
Building 1 Obs Exp SMR 95% CI
12
16.3 0.74 0.38 - 1.29
3
5.0 0.60 0.12 - 1.74
1
0.2 6.43 0.16 - 35.81
0
0.3
--- 0.00 - 14.63
0
1.6
--- 0.00 - 2.31
0
0.3
--- 0.00 - 12.50
0
0.2
--- 0.00 - 20.75
1
0.5 1.96 0.05 - 10.90
1
0.2 5.04 0.13 - 28.09
1
0.4 2.65 0.07 - 14.77
0
0.7
--- 0.00 - 5.36
6
4.3 1.39 0.51 - 3.03
5
3.2 1.56 0.51 - 3.64
1
1.3 0.74 0.02 - 4.14
1
0.7 1.51 0.04 - 8.42
1
0.3 3.40 0.09 - 18.93
0
0.2
--- 0.00 - 23.99
0
1.8
--- 0.00 - 2.07
0
1.1
--- 0.00 - 3.25
0
0.6
--- 0.00 - 6.17
0
0.5
--- 0.00 - 6.85
0
Internals Obs Exp SMR 95% CI
12
8.7 1.37 0.71 - 2.40
3
2.3 1.33 0.27 - 3.88
0
0.1
--- 0.00 - 41.32
0
0.1
--- 0.00 - 30.29
2
0.7 3.07 0.37 - 11.10
1
0.1 10.21 0.26 - 56.87
0
0.1
--- 0.00 - 27.95
0
0.2
--- 0.00 - 14.95
0
0.1
--- 0.00 - 37.88
0
0.2
--- 0.00 - 19.42
1
0.2 4.60 0.12 - 25.63
3
1.9 1.55 0.32 - 4.53
2
1.4 1.42 0.17 - 5.12
0
0.4
--- 0.00 - 9.70
0
0.2
--- 0.00 - 20.39
1
0.2 4.13 0.10 - 23.01
0
0.1
--- 0.00 - 67.49
1
2.2 0.46 0.01 - 2.53
1
1.4 0.72 0.02 - 4.00
1
0.8 1.22 0.03 - 6.77
0
0.6
--- 0.00 - 6.45
1
Maintenance Obs Exp SMR 95% CI
11
16.1 0.68 0.34 - 1.22
4
5.1 0.78 0.21 - 2.01
0
0.2
--- 0.00 - 17.52
0
0.3
--- 0.00 - 13.24
3
1.8 1.65 0.34 - 4.81
0
0.0
--- 0.00 - 78.19
0
0.2
--- 0.00 - 19.37
0
0.5
--- 0.00 - 6.91
0
0.2
--- 0.00 - 18.34
1
0.4 2.54 0.06 - 14.16
0
0.6
--- 0.00 - 6.33
4
4.6 0.87 0.24 - 2.22
4
3.5 1.13 0.31 - 2.90
1
1.2 0.82 0.02 - 4.58
1
0.6
--- 0.00 - 5.74
0
0.3
--- 0.00 - 10.90
0
0.1
--- 0.00 - 27.42
2
1.7 1.20 0.15 - 4.34
2
1.1 1.87 0.23 - 6.74
1
0.6 1.80 0.05 - 10.05
1
0.5 1.93 0.05 - 10.77
0
Table 11. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for All Malignant Neoplasms
All Jobs
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 1/1.5 1/1.4 0/0.0 0/0.0 2/3.0
Latency (yrs) 10-19 20 1/1.3 5/3.6 3/3.1 1/2.9 3/1.6 0/4.9* 0/0.0 3/4.4 7/5.9 9/15.9
TOTAL 7/6.5 5/7.4 3/6.5 3/4.4 18/24.7
All Malignant Neoplasms
Building 1
< 10 2/1.0 0/0.5 0/0.0 0/0.0 2/1.5
Latency (yrs) 10-19 20 0/0.7 0/1.6 2/1.3 1/1.5 1/0.4 0/1.5 0/0.0 0/0.4 3/2.5 1/4.9
TOTAL 2/3.3 3/3.3 1/1.9 0/0.4 6/8.9
Internals
< 10 0/0.8 0/0.3 0/0.0 0/0.0 0/1.1
Latency (yrs) 10-19 20 2/1.2 2/4.0 1/0.7 1/1.1 0/0.3 0/0.9 0/0.0 2/0.8 3/2.2 5/6.8
TOTAL 4/6.0 2/2.1 0/1.2 2/0.8 8/10.2
Mag Oxide
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.3 1/0.2 0/0.0 0/0.0 1/0.5
Latency (yrs) 10-19 20 0/0.3 0/0.6 0/0.5 0/0.6 1/0.1 0/0.5 0/0.0 0/0.2 1/0.9 0/1.9
TOTAL 0/1.2 1/1.3 1/0.6 0/0.2 2/3.3
Maintenance
< 10 0/1.0 0/0.5 0/0.0 0/0.0 0/1.4
Latency (yrs) 10-19 20 0/1.2 4/2.9 2/1.0 0/0.8 0/0.5 0/1.5 0/0.0 0/0.9 2/2.7 4/6.2
TOTAL 4/5.1 2/2.2 0/2.0 0/0.9 6/10.3
Warehouse
< 10 0/0.5 1/0.2 0/0.0 0/0.0 1/0.7
Latency (yrs) 10-19 20 2/0.9 1/1.9 0/0.5 1/0.6 0/0.1 0/0.4 0/0.0 0/0.2 2/1.5 2/3.1
TOTAL 3/3.3 2/1.2 0/0.5 0/0.2 5/5.3
* p 0.05; **p 0.01
Table 12. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Cancer of Pancreas
All Jobs
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.1 1/0.1 0/0.0 0/0.0 1/0.1
Latency (yrs) 10-19 20 0/0.1 1/0.2 0/0.1 0/0.2 1/0.1 0/0.3 0/0.0 0/0.3 1/0.3 1/0.9
TOTAL 1/0.3 1/0.4 1/0.4 0/0.3 3/1.3
Cancer of Pancreas
Building 1
< 10 0/0.0 0/0.0 0/0.0 0/0.0 0/0.1
Latency (yrs) 10-19 20 0/0.0 0/0.1 0/0.1 0/0.1 1/0.0* 0/0.1 0/0.0 0/0.0 1/0.1 0/0.3
TOTAL 0/0.2 0/0.2 1/0.1 0/0.0 1/0.5
Internals
< 10 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0
Latency (yrs) 10-19 20 1/0.1 1/0.2 0/0.0 0/0.1 0/0.0 0/0.1 0/0.0 0/0.1 1/0.1 1/0.4
TOTAL 2/0.3 0/0.1 0/0.1 0/0.1 2/0.6
Mag Oxide
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.0 1/0.0* 0/0.0 0/0.0 1/0.0*
Latency (yrs) 10-19 20 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.1
TOTAL 0/0.1 1/0.1 0/0.0 0/0.0 1/0.2
Maintenance
< 10 0/0.0 0/0.0 0/0.0 0/0.0 0/0.1
Latency (yrs) 10-19 20 0/0.1 0/0.2 0/0.0 0/0.0 0/0.0 0/0.1 0/0.0 0/0.1 0/0.1 0/0.4
TOTAL 0/0.3 0/0.1 0/0.1 0/0.1 0/0.6
Warehouse
< 10 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0
Latency (yrs) 10-19 20 2/0.0** 0/0.1 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 2/0.1** 0/0.2
TOTAL 2/0.2* 0/0.1 0/0.0 0/0.0 2/0.3
* p 0.05; **p 0.01
Table 13. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Cancer of Lung
All Jobs
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.3 0/0.4 0/0.0 0/0.0 0/0.7
Latency (yrs) 10-19 20 1/0.4 2/1.2 2/1.0 0/1.0 1/0.5 0/1.7 0/0.0 3/1.5 4/1.9 5/5.4
TOTAL 3/1.9 2/2.4 1/2.2 3/1.5 9/8.0
Cancer of Lung
Building 1
< 10 1/0.3 0/0.2 0/0.0 0/0.0 1/0.4
Latency (yrs) 10-19 20 0/0.2 0/0.5 1/0.4 0/0.5 0/0.1 0/0.5 0/0.0 0/0.1 1/0.8 0/1.6
TOTAL 1/1.0 1/1.1 0/0.6 0/0.1 2/2.8
Internals
< 10 0/0.2 0/0.1 0/0.0 0/0.0 0/0.2
Latency (yrs) 10-19 20 1/0.3 0/1.3 1/0.2 1/0.4 0/0.1 0/0.3 0/0.0 2/0.3 2/0.6 3/2.3
TOTAL 1/1.8 2/0.6 0/0.4 2/0.3 5/3.1
Mag Oxide
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.1 0/0.1 0/0.0 0/0.0 0/0.1
Latency (yrs) 10-19 20 0/0.1 0/0.2 0/0.2 0/0.2 0/0.0 0/0.2 0/0.0 0/0.1 0/0.3 0/0.7
TOTAL 0/0.4 0/0.4 0/0.2 0/0.1 0/1.1
Maintenance
< 10 0/0.3 0/0.1 0/0.0 0/0.0 0/0.4
Latency (yrs) 10-19 20 0/0.4 3/1.0 2/0.3 0/0.3 0/0.2 0/0.6 0/0.0 0/0.3 2/0.9 3/2.2
TOTAL 3/1.7 2/0.7 0/0.7 0/0.3 5/3.5
Warehouse
< 10 0/0.1 1/0.0 0/0.0 0/0.0 1/0.2
Latency (yrs) 10-19 20 0/0.3 1/0.7 0/0.2 1/0.2 0/0.0 0/0.1 0/0.0 0/0.1 0/0.5 2/1.1
TOTAL 1/1.1 2/0.4 0/0.2 0/0.1 3/1.7
* p 0.05; **p 0.01
Table 14. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Heart Disease
All Jobs
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 1/1.5 1/1.4 0/0.0 0/0.0 2/2.9
Latency (yrs) 10-19 20
TOTAL
0/1.1 4/2.9 5/5.5
1/2.8 1/2.7 3/7.0
1/1.5 4/4.1 5/5.6
0/0.0 3/3.5 3/3.5
2/5.5 12/13.2 16/21.6
Heart Disease
Building 1
< 10 1/0.8 0/0.5 0/0.0 0/0.0 1/1.3
Latency (yrs) 10-19 20 0/0.6 2/1.1 0/1.1 1/1.3 1/0.3 2/1.2 0/0.0 0/0.3 1/2.1 5/4.0
TOTAL 3/2.6 1/2.9 3/1.6 0/0.3 7/7.3
Internals
< 10 0/0.7 0/0.3 0/0.0 0/0.0 0/1.0
Latency (yrs) 10-19 20 0/1.1 2/3.4 0/0.7 0/0.9 0/0.3 1/0.8 0/0.0 2/0.7 0/2.2 5/5.8
TOTAL 2/5.3 0/1.9 1/1.1 2/0.7 5/9.0
Mag Oxide
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.3 0/0.2 0/0.0 0/0.0 0/0.5
Latency (yrs) 10-19 20 0/0.3 0/0.4 0/0.4 0/0.5 0/0.1 0/0.4 0/0.0 0/0.2 0/0.8 0/1.5
TOTAL 0/1.1 0/1.1 0/0.5 0/0.2 0/2.9
Maintenance
< 10 0/1.0 1/0.5 0/0.0 0/0.0 1/1.5
Latency (yrs) 10-19 20 0/1.2 2/2.4 1/0.9 0/0.7 0/0.5 1/1.2 0/0.0 1/0.7 1/2.6 4/5.1
TOTAL 2/4.6 2/2.1 1/1.7 1/0.7 6/9.1
Warehouse
< 10 0/0.5 0/0.2 0/0.0 0/0.0 0/0.7
Latency (yrs) 10-19 20 0/0.9 1/1.6 0/0.4 0/0.5 0/0.1 0/0.3 0/0.0 0/0.1 0/1.4 1/2.6
TOTAL 1/3.0 0/1.1 0/0.4 0/0.1 1/4.6
* p 0.05; **p 0.01
Table 15. Observed versus Expected Deaths, by Major Department, Years Worked, and Latency Interval, Using Regional White Mortality Rates for Expected Deaths for Cirrhosis of Liver
All Jobs
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.2 0/0.2 0/0.0 0/0.0 0/0.3
Latency (yrs) 10-19 20 1/0.1 1/0.3 1/0.3 0/0.1 0/0.2 1/0.3 0/0.0 1/0.4 2/0.5 3/1.1
TOTAL 2/0.6 1/0.5 1/0.5 1/0.4 5/2.0
Cirrhosis of Liver
Building 1
< 10 0/0.1 0/0.0 0/0.0 0/0.0 0/0.1
Latency (yrs) 10-19 20 0/0.1 1/0.1 1/0.1 0/0.1 0/0.0 1/0.1 0/0.0 0/0.0 1/0.2 2/0.3
TOTAL 1/0.3 1/0.2 1/0.1 0/0.0 3/0.6*
Internals
< 10 0/0.1 0/0.0 0/0.0 0/0.0 0/0.1
Latency (yrs) 10-19 20 0/0.1 1/0.4 0/0.1 1/0.1 0/0.0 0/0.1 0/0.0 1/0.1 0/0.3 3/0.6
TOTAL 1/0.6 1/0.2 0/0.1 1/0.1 3/1.0
Mag Oxide
Years Worked < 5 yrs 5 - 14 yrs 15 - 24 yrs 25 yrs TOTAL
< 10 0/0.0 0/0.0 0/0.0 0/0.0 0/0.1
Latency (yrs) 10-19 20 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.1 0/0.1
TOTAL 0/0.1 0/0.1 0/0.0 0/0.0 0/0.2
Maintenance
< 10 0/0.1 0/0.1 0/0.0 0/0.0 0/0.2
Latency (yrs) 10-19 20 1/0.1 0/0.2 0/0.1 0/0.0 0/0.0 0/0.1 0/0.0 0/0.1 1/0.2 0/0.4
TOTAL 1/0.4 0/0.2 0/0.1 0/0.1 1/0.8
Warehouse
< 10 0/0.1 0/0.0 0/0.0 0/0.0 0/0.1
Latency (yrs) 10-19 20 1/0.1 0/0.2 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 0/0.0 1/0.1 0/0.2
TOTAL 1/0.3 0/0.1 0/0.0 0/0.0 1/0.4
* p 0.05; **p 0.01
Table 16. Risk Factor Information for 5 Cirrhosis of the Liver Deaths
Person A B C D E
Death Certificate Alcohol Alcohol No information No information No information
Risk Factor Information Source 3M Medical Record Review
No 3M medical record found Abnormal liver chemistry tests No 3M medical record found No risk factor information found on 3M medical record Heavy alcohol use, abnormal liver chemistry tests
Appendix
Appendix Figure 1. Appendix Table 1. Appendix Table 2.
Illinois County Map
3M Cordova Facility Evolution
Top Raw Materials, Top Products, and Changes or Trends by Focus Factory
Appendix Figure 1. Illinois County Map
Appendix Table 1. 3M Cordova Facility Evolution
1970 First Chemical Production 1973 First Mag Oxide Production 1976 First Fluorochemical Production and Polymer Expansion 1977 Office, Laboratory, and Warehouse Expansion 1981 Fluorochemical Cell Expansion 1983 Fluorochemical Reactor Expansion 1986 Boilerhouse, Wastewater Treatment, and Utility Expansion 1987 Polymer Expansion (Building 23) 1988 Fluorochemical Cell Expansion 1990 Office and Laboratory Expansion 1995 IOA Continuous Distillation 1996 Building 20 HFE Expansion 1998 Fluorochemical Expansion (Building 30) 1999 IOA, GMP, and Polymer Expansion; CS-15, Building 30 Packaging 2001 Fire Station (Building 74) 2003 Thermal Oxidizer
Appendix Table 2. Top Raw Materials, Top Products, and Changes or Trends by Focus Factory
Top Raw Materials
Electronics Anhydrous Hydrogen Fluoride (HF)
Potassium Hydroxide (KOH) Isobutyric Anhydride Dimethyl Sulfate
Internals Isooctyl Alcohol
Acrylic Acid KOH Heptane
Top Products
C3/C4 Acid Fluorides NovecTM 1230 Fire Protection Fluid
NovecTM 7100 Engineered Fluid
Isooctyl Acylate
Super Seximer family of water based adhesives (used in Scotch MagicTM Tape, Scotch-BlueTM Painters Tape)
High Performance Synthetics (HPS) Solution Polymers
Changes/Trends
Increased HF, Perfluorobutanesulfonyl Fluoride (PBSF), C3/C4 Acid Fluorides
Increased use of Acrylamides Decreased Methylene Bisphenyl Isocyanate (MDI) use, Epoxy Resins, and Stain Release Production No longer use Toluene2,4-Diisocyanate (TDI) No longer manufacture K-salt master premix that was used as a post-market carpet application. Contained PFOS and PFHxS.
