Document 0gapRwa5n9xGxz0NL2dnRRb5O

A PROPORTIONAL MORTALITY STUDY OP MONSANTO-INDIAN ORCHARD PLANT EMPLOYEES SUMMARY In a proportional mortality analysis of 564 deceased MonsantoIndian Orchard plant workers, no statistically significant excess was seen in the overall number of deaths due to cancer or in the number of deaths from any specific cancer site, including cancer of the pancreas. There is no suggestion of an increased proportion of cancer deaths when analyzed site-specifically by age at death,' year of death, or by the number of years since started working. An analysis of cancer deaths by place of birth revealed an excess of prostate cancer among the U. S. born, but not among the foreign born. This differential by place of birth has not been explained. No statistically significant excess was seen in any of several'nonmalignant cause of death categories, with the exception of arterio sclerotic heart disease. BACKGROUND In 1975, a Massachusetts activist group and a Massachusetts State Occupational Hygiene Physician reported that their examination of 86 death certificates indicated an overall excess of cancer and an excess of cancer of the pancreas among former Monsanto-lndian Orchard plant workers. In response to these concerns, Monsanto provided additional mortality data to the National Institute for Occupational Safety and Health, and independently initiated a proportional mortality epidemiology study to determine if there was an increased proportion of deaths from all cancers or from cancer of the pancreas, and if there was an in creased proportion of deaths from any of the major non-malignant causes of death. METHODOLOGY Selected for study were the 564 deaths observed from 1950 through 1976 among workers and former workers of the Monsanto-lndian Orchard plant. The decedents were identified mainly from personnel and medical benefits records and are basically comprised of persons who died while they were active employees and of pensioned employees who are known to have died. The death certificates of females and non-white males were excluded from analysis because of their relatively small number of deaths. All deaths were confirmed by death certificate. Information on underlying cause of death was coded from the death certificate by an independent trained nosologist to the Seventh.Revision of the Inter national Classification of Diseases, Adapted. The data were analyzed by the proportional mortality methodrwhereby the observed number of deaths is compared to an expected number of deaths based on standard population. For each cause of death, a proportional mortality ratio was calculated as the ratio of the number of observed deaths to the number of expected deaths. Proportional mortality ratios were calculated for fourteen cancer categories by age at death, year of death, number of years since started working,.and place of birth. RSV0027145 PT -2- Proportional mortality analyses were carried out using the age groupings: 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80+. The expected number of deaths was calculated based on mortality data from the Vital Statistics of' the United States^"1'* according to the formula: 2 Expected^ = P ? * Tjksjk. Where T3..k = number of observed deaths from all causes in the jth age group of the study population. sjk = nun'^,er deaths from cause k in the jth age group of the standard population. Sj - number of deaths from all causes in the jth age group of the standard population, p = time interval. Where U. S. death rates were coded to the Eighth Revision of the I.C.D.^ conversion was made to the Seventh Revision using comparability ratios. For each cause of death, an expected number of deaths was calculated over three time periods: 1950-1959, 1960-196.9, 19 70-1976, using mortality data from 1955, 1965, and 1973, respectively. For cancer deaths, the expected numbers based on U. S. rates were adjusted for the local cancer mortality-rate using data from U. S. Cancer Mortality by County: 1950-1969. The expected numbers were adjusted, site-specifically, according to the ratio of the Hampden County mortality rate to the U. S. mortality rate. The adjustment factors are given in Appendix A. It should be noted that the expected numbers for the sub-cancer categories will not add to the total expected numbers for the main cancer categories because of weighting factors. Mortality data on non-malignant causes of death are not generally available by county. The expected numbers for the non-cancer deaths are based only on U. S. rates. The total number of observed deaths will not equal the total number of expected deaths because the cancer cause of death categories have been adjusted for the local death rate. A chi-square statistic was calculated for the observed and expected number of deaths where there were at least five expected and observed cases. Tests of significance using binomial probabilities were calcu lated where the number of expected or observed cases was less than five. All tests were made at the 5% level of significance. Tests of signifi cance for the overall cancer and pancreatic cancer categories are actually the only valid comparisons that can be made. Tests of significance for the other cause of death categories were carried out realizing that the probability of a comparison showing significance by chance alone increases with the number of comparisons made. With n comparisons, the probability of being wrong in one or more comparisons is 1 - (.95) . RSV0027146 RESULTS No statistically significant excess was seen in the overall number of cancer deaths with 118 observed and 116.75 expected (Table I). No increase was seen in deaths from pancreatic cancer with 6 observed and 6.89 expected. No significant increase was seen in any. of the other cancer mortality sites. With the exception of deaths from arteriosclerotic heart disease (237 observed with 203.23 expected), there is no suggestion of an increased proportion of deaths from any of several non-malignant causes of death. The analysis of cancer deaths by age at death (Table II), year of death (Table III), and the number of years since started working (Table IV) did not reveal any consistent trends that would indicate a positive association between employment and excess cancer mortality. In studying a relatively stable working population as we are here, one would look for increasing proportional mortality ratios, with increasing age at death, with more recent years of death, or with longer lengths of time since started working, as an indication of an occupational carcinogen operating on the mortality experience of workers. An analysis by birthplace was also carried out revealing a statistically significant excess of prostate cancer in the U. S. born. There were 9 cases of prostate cancer with 4.59 expected. There was no excess among the foreign born with 3 observed deaths and 3.67 expected. DISCUSSION - When studying cancer, the most representative rates to use in computing expected mortality are usually the mortality rates for the local population in the area in which the plant is located. The Indian Orchard plant is located in Hampden County, Massachusetts. Cancer mortality data are available on an age-adjusted site-specific basis for the period 1950-1969. There are some circumstances which might not favor the use of county mortality data. These include: 1) a large percentage of the county population may be employed in the plant under study, and 2) the county may have an unusually high concentration of related heavy industry and the industrial emissions could adversely affect the health experience of the surrounding community. However, these factors are not applicable to the present study in which data from Hampden County are used to assess the mortality experience of Indian Orchard plant employees. Based on Hampden County data, the- proportional mortality ratios do not show any consistent trends that would indicate an increased proportion of deaths from all cancers, pancreatic cancer, or from any site-specific cancer, with the exception of prostate cancer in the U. S. born. A review of the work histories of the prostate cancer cases was made to determine if there was any commonality in occupational exposures among the U. S. born that could account for the differential in prostate cancer by birthplace. The results of the work history analysi is detailed in Appendix B. There does not appear to be any departmental RSV0027147 x -4clustering that could explain the excess. However,-no further con clusions can be drawn because the small numbers of cases scattered over several departments will not permit a valid case~control analysis. An `excess was also seen in the number of deaths from arterio sclerotic heart disease, with 237 observed deaths and 203.23 expected. There was no overall excess in the number of deaths from cardiovascular disease with 318 observed and 307.23 expected, so that the excess in deaths from arteriosclerotic heart disease may be due to a deficiency of deaths from other cardiovascular disease. The proportional mortality method used here to screen for occupationally related diseases did not reveal any increased proportions in deaths that could be directly linked to occupational factors. Judith Killeen March 13, 1978 RSV0027148 REFERENCES 1. World Health Organization; International' Classification of Diseases/ 1955 revision, Geneva, 1957. 2. Vital Statistics of the United States 1955, Volume II - Mortality Data, HEW Public Health Service, Washington, 1957. 3. Vital Statistics of the United States 1965, Volume II - Mortality, Part A, HEW Public Health Service, Washington, 1967. 4. Vital Statistics of the United States T973, Volume II - Mortality, Part A, DHEW Pub. NoV "(HRA) 77-1101. 5. Mortality Trends for Leading Causes of Death; United States ~ 1950-69, DHEW Pub. No. (HRA) 74-1853. 6. Mason TJ, et al: U.S. Cancer Mortality by County; 1950-1969, DHEW Pub. NO. (NIH) 74-615. J RSV0027149 Table I Observed and Expected Deaths, 1950-1976 1t Cause of Death with I.C.D. No. (Seventh Revision) Observed Expectedt P.M.R. Tuberculosis (001-019) Malignant neoplasms (140-205) Buccal cavity and pharynx (140-148) Digestive organs and peritoneum (150-156A.157-159) Biliary passages and liver (155) Pancreas (157) All other digestive organs (Residual) Respiratory system (160-164) Genital organs (177-179) Prostate (177) All other genital organs (Residual) Urinary organs (180-181) Other and unspecified sites (Residual) Leukemia and aleukemia (204) lymphomas (200-203,205) Diabetes mellitus (260) Diseases of cardiovascular system (330-334,400-468) ^icular lesions affecting CNS (330-334) l^Paraatic heart disease (400-402,410-416) Arteriosclerotic heart disease (420) Nonrheumatic chronic endocarditis (421-422) Other diseases of heart (430-434) Ifypertensive heart disease (440-443) Other hypertensive disease (444-447) General arteriosclerosis (450) Other diseases of circulatory system (451-468) : Influenza and pneumonia (480-493) Ulcer of stomach and duodenum (540-54l) Appendicitis (550-553) Hernia and intestinal obstruction (560-561,570) Gastritis, duodenitis, enteritis, and colitis (543,571-572) Cirrhosis of liver (581) Nephritis and nephrosis (590-594) Hyperplasia of prostate (610) Symptoms, senility, and ill-defined conditions Motor vehicle accidents (E810-E835) Other accidents (E800-E802,E840-E962) Suicide <E963,E9?0-E979) Homicide (E964.E980-E985) All other causes (Residual) 0 118 3 46 3 6 37 24 14 12 2 7 15 2 7 9 318 41 5 237 6 6 5 3 8 7 14 2 2 2 3 9 5 1 2 10 16 8 0 45 3-73 116.75 4.43 39.20 1.51 6.89 31.07 33.34 8.78 8.27 0.45 6.69 11.89 4.10 6.70 7.99 307.53 44.07 5.57 203.23 8.79 10.41 10.98 2.40 5.99 7-52 13.00 4.53 .57 2.11 1.07 13.14 3.67 1.40 6.19 16.14 18.53 11.68 2.82 44.71 1.01 .68 . 1.17 1.99 .87 1.19 _jtZ2 0*59, 1^45 4.44 1.05 1.26 .49 1.04 1.13 1.03 93 9. 1.17 .68 *58 .46* 1.25 1.34 .93 1.08 .44 3.51 .95 2.80 .68 i.36 .71 .32 .62 .86 .68 ---- 1.01 ^,ited numbers for cancer deaths adjusted for Hampden County, Mass, rates Significant at the 5$ level RSV0027150 f i Cause of Death Table II Observed and Expected Deaths by Age at Death Age at Death: 20-49 Observed Expected^` P.M.R. 50-69 Observed Expected P.M.R. Malignant neoplasms Buccal cavity and pharynx Digestive organs and peritoneum Biliary passages and liver Fancreas All other digestive organs Respiratory system Genital organs Prostate All other genital organs Urinary organs Other ana unspecified sites Leukemia and aleukemia Lymphomas 17 0 10 .1 3 6 3 1 0 l 0 2 0 1 15.48 0.58 3.97 0.13 0.?6 3-07 4.16 0.48 0.08 0.26 0.60 2.59 0.86 ' 1.64 1.10 -- 2.52 7.69 3-9^ 1.95 .72 2.08 3.84 -- .77 -- .6i 69 2 25 2 3 20 20 6 ... 5 1 3 7 2 4 * 70.09 2.96 23.40 0.95 4.25 18.36 22.50 3-60 3.46 0.14 3.95 6.89 2.09 3.80 .98 .68 1.07 2.11 .71 1.09 .89 1.6? 1.45 7.14 .76 1.02 .96 1.05 70+ .Observed - Expected P.M.R. 32 31.18 1.03 1 ~0.89 1.12 11 11.83 - .93 0 O.43 0 1.8? 11 9.64 1.14 1 6.68 .15* 7 4.?i 1,49 7 4.74 1.48 0 0.04 4 2.13 * 1.88 6 2.40 2.50* 0 1.14 2 1.2? 1.57 ^Expected numbers Tor cancer deaths adjusted for Hampden County, Mass. rates ^Significant at the 5$ level x/x < o oto -o Table III i Observed and Expected Deaths by Year of Death Cause of Death Year of'Death;__________________1950-1959_____________________________1960-1969____________________________1970-1976 Observed Expected*!" P.M.R. Observed Expected P.M.R. Observed Expected P.M.R. Malignant neoplasms Buccal cavity and pharynx Digestive1 organs and peritoneum Biliary passages and liver Pancreas All other digestive organs Respiratory system Genital organs Prostate /JL1 other genital organs Urinary organs Other and unspecified sites . leukemia and aleukemia Lymphomas 32 0 12 .0 1 OP 8 4 4 0 2 3 0 3 26.77 1.13 10.64 0.42 1.52 8.82 5.94 2.13 1.9^ 0.15 1.62 2.68 1.04 1.50 1.20 -- 1.13 -- .66 1.25 1.35 1.88 2.06 ~ 1.23 1.12 -- 2.00 46 1 17 1 3 13 ' 9 6 4 2 4 6 1 2 48.55 1.89 16.19 0.81 2.91 12.52 14.10 3.41 3.18 0.19 2.76 5.03 1.73 2.78 .95 .53 I.05 1.23 1;03 1.04 .64 1.76 1.26 10.53 1.45 1.19 .58 .72 40 2 17 2 2 13 7 4 4 0 1 6 1 2 41.43 1.41 12.37 0.28 2.46 9-73 13*30 3.24 3.15 0.11 2.31 4.18 1.33 2.42 .97 1.42 1*37 7.14* .81 1.34 53 1.23 1.27 -- .43 * 1.44 .75 .83 ^Expected numbers for cancer deaths adjusted for Hampden County, Mass, rates *Signifleant at the 5# level fMa <OONJ to Table IV ;i Observed and Expected Deaths by Number of Years .since Started Working lmiiuer ui xecu s Cause of Death ducu ucu nurxvx -____ 'V fcy .YtScU'S Observed Expectedt P.M.R. ___________ tAi'S Observed Expected P.M.R. Malignant neoplasms Buccal cavity and pharynx Digestive organs and peritoneum Diliary passages and liver Fancreas All other digestive organs Respiratory system Genital organs Prostate All other genital organs Urinary organs Other and unspecified sites Leukemia and aleukemia Lymphomas 34 0 10 .0 i 9 8 4 2 2 2 5 1 4 34.4? 1.38 11.29 0.44 1*93 8.96 9.57 1.82 1.36 0.27 1.81 4.13 1.41 2.40 .99 .-- .89 - 52 1.00 .84 2.20 1.47, 7.4l 1.10 1.21 .71 1.67 . 41 2 16 1 2 13 9 5 5 0 1 5 l 2 40.20 1.59 13.09 0.50 2.39 10i28 12.33 2.57 2.46 0.11 2.25 4.13 1.31 2.29 1.02 1.26 1.22 2.00 .84 1.26 .73 1.95 2.03 -- .44 1.21 .76 .87 JU jrccu a Observed Expected P.M.R. 43 1 20 2 3 15 7 5 5 0 4 5. 0 1 42.05 1.14 14.80 0.57 2.53 11.84 11.42 4.38 4.36 0.06 2.62 3.62 1.38 2.04 1.02 .88 i-35 3-51 1.19 1.2? .61 1.14 1.15 --- 1.53 . 1.38 -- 0.49 fExpected numbers for cancer deaths adjusted for Hampden County, Hass* rates *Signifleant at the 5$ level Table V Observed and Expected Deaths by Place of Birth Place of Birth! U .S. Born Foreign Born Cause of Death Observed Expected^ P.M.R. t, Observed Expected P.M.R. Malignant neoplasms Buccal cavity and pharynx Digestive organs and peritoneum Biliary passages and liver Pancreas All other digestive organs Respiratory system Genital organs Prostate All other genital organs. Urinary organs Other and unspecified sites Leukemia and aleukemia Lymphomas 80 2 : 29 !. 2 23 18 10 9 1 4 10 2 '5 82.13* 3.22 26.24 0.97 ^.33 20.63 24.84 5.06 4.59 O.37 4.46 8*87 2.90 5.09 97. .62 i.ll 2.06 .92 1.11 72 1.98* 1.96* 2.70 .90 1-13 .69 .98 38 .1 1? 1 2 14 6 4 3 ' 1 3 5 0 2 . 34.63 1.23 12.96 0.52 2.05 10.47 8.51 3.71 3.67 0,09 2.22 2.99 1.20 1.6l 1.10 .81 1.31 1.92 .98 1.34 -71 1.08 .82 11.11 1.35 1.6? 1.24 ^Expected numbers for cancer deaths adjusted for Hampden County, Mass, rates '"significant at the 5# level !t &i<ot~noo Appendix A Ratios of Hampden County to U.S. Cancer Mortality Rates, White Males, 1950-1969 Cause of Death Hampden County Rate* Malignant neoplasms Buccal cavity and pharynx Digestive organs and peritoneum Biliary passages and liver Pancreas All o> her digestive organs Respiratory system G nital organs Prostate ^^11 other genital organs nary organs Other and unspecified sites Leukemia and aleukemia lymphomas 192.5 a 7.0 S 71.3 5.5 11.0 * 54.8 42.2 2? 20.0 '19.4 a 0.6 11.9 a 10.0 8.5 9.8 U.S. Rate 174.04 ` S5-36 58.30 5.16 9.63 a 43.51 40.95 18.6? 17-84 s 0.83 10.64 s 10.73 8.81 8.94 *Rate per 100,000 population Adjustment Factor 1.11 a 1.31 a 1.22 1.07 1.14 1.26 1.03 a 1.07 1.09 = 0.72 1.12 s 0.93 0.96 1.10 RSV0027155 < APPENDIX B WORK EXPERIENCE BY DEPARTMENT OF PROSTATE CANCERDEATHS DEPARTMENT S Sheet IRasinox Saflex Vuepak Lustrex U. S. Bom Case 1 Case 2 Case 3 Case 4 Case 5 Case 6 Case 7 Case 8 Case 9 X X X (j) Foreign Bom Case 1 Case 2 Case 3 <3 x (5p x X PVC X Yard Shipping Law Maintenance Storeroom Guards Xa l &X / X Legend: Sheet - cellulose nitrate,cellulose acetate, (2)~ MDST EEPRESENIATIVE DEPARTMENT Resinox - phenol - formaldehyde resins. < Saflex - polyvinyl butyral. x = EVER WORKED DEPARTMENT Vuepak - cellulose acetate. &in < Lustrex - polystyrene. PVC - polyvinyl chloride. o oto -4 U> Ch