Document J3NnQ323zBrBN7D2RGgJdY3gv

^ ` c?t+tuf s^Uy J y /a Xv, /_*;*:/. J jLj&ccij ^{>,<xj '<./ ^f uJu/si> y^aT tf*y t,-os,'~+a^ tU s-'w/* v a^/v* ^.' *^:- /, ''. ?<S.''*r'~' !' Adyt>y Jn C*t+i'&,?:**. in:'-.' July 3, 1373 $ /A._ ^/V^z. C-u:.;,: .-. . ;* .j 1:. Jr., V. 1>. Jxtcufcr, 7Ju:-c. o." '' I:rcivu; 6 /'vir.va-;cr.i:j.l ITruXih Tic : r:\,'.r;tr3 Jcv'-ccy coo :;. n.v.j. Si;. I.mjLrT. i'.'j oJZt;5 i)?**: ur. "outIi: Hr. 'Jnr-jil ;-toa^o ff.r 1 a 20^y of v.ho VICkV, wyort or.; li.lt d :`.\ Fra-urr.iru ..t *\.i ';clitv .`r.aj.ya :.n c; a Cl.: "-c.''! >1-:': in :'r.oa-,oi'';2ry:rL.`.'' TM'S v;'T /.'.'a^u . ruy 1^/7 Vioci-'t Hy ii'.v: 4 ^ar.idinj auy. 's: i: '.'.-.la pa<in. Ly v,.'.nr:y,CT;-'u i . I.'.Icy, md a^.-ilcviic cnviv VhrnV van for yovr hrln lu i'l.lc cy. J.uTcrroiy ycuro, Pji'.'Vt 'I': .i t a : r\ RSV 0007560 A PROPORTIONAL MORTALITY ANALYSIS OF A CHEMICAL PLANT IN MASSACHUSETTS BY Karen Stanislawczyk*, M.P.H. Rose Kaminski, MS. Hyg. Robert Spirtas, Dr. P.H. .Illness Effects Section, SB/DSHEFS/NIOSH Robert A. Taft Laboratories 4676 Columbia Parkway Cincinnati, Ohio 43226 Currently employed by Colorado State University, College of Veterinary Medic and Biomedical Sciences, Institute of Rural Environmental Health, Colorado Epidemiologic Pesticide Studies Center, Fort Collins, Colorado May 1978 *SV 0007561 rmopo:.a' i.u.. *i. mu . my. l j'rv lx-. ; - li.~i ek_r round In 1975, NICSH was informed of an apparent unusual frequency of deaths from pancreatic cancer among former workers of Monsanto Polymers and Resins Company, Indian Orchard plant in Massachusetts. This information arose frerr. efforts of a group of workers concerned about a- possible pro blem in areas of the plant where vinyl chloride had been used, it was based on a grossly incomplete listing of 86 death certificates from former employees of the Monsanto Indian Orchard facility which were reported to a NIOSH physician stationed in Boston. NIOSH review of causes of death entered on the death, certificates indicated cancer was the underlying cause in 21 cases, and pancreatic cancer in 4 of these. Based on the proportion of cancer deaths to all deaths in the general white male population, the expected number from 86 deaths estimated by NIOSH was 15.3 deaths from cancer and 1 death from pancreatic cancer. Further reason for concern was stated because two of the four pancreatic cancer cases were only 42 and 43 years of age at death. In response to these concerns, Monsanto searched out, collected and supplied over 465 death certificates for NIOSH selection and examination of causes of death for a more complete group of workers at the Indian Orchard, Massachusetts facilities over a defined period of time. Draft results of the NIOSH analysis have been publicized and were presented at an APHA meeting in Washington, D. C. on November 1, 1977. K$V 0007562 Page In the oresent studv reported by Monsanto, all of the available mortality data on workers supplied for NIOSH plus additional mortality data collected throuqh August 15 , 19 77, have been utilized, (total 59 3 deaths'. This epidemiologic study was initiated to answer the following questions: 1. Does the number of pancreatic deaths of Monsanto-Springfield v/orkers exceed the number expected based on U.S. rates for white males, adjusted for geographic locality, for the specified study period? 2. More generally, does the pattern of mortality in Monsanto-Springfield workers differ significantly from what would be expected? Methodology This is a study of male Monsanto-Springfield Indian Orchard Plant workers. The population was followed for deaths from 1/1/50 - 4/22/76. A total of 593 death certificates were obtained from 564 white and 29 non-white males. Mon-white malos were excluded from analysis because of their relatively small number of deaths. The study population, consisting of 564 white males, represents all identified deaths regardless of length of employment, date of termination, or eligibility for death benefits. All death certi ficates were coded to an underlying cause by an experienced independent nosologist. All coding was made to the Seventh Revision of the Internationa! Classification of Diseases. The data were analyzed using the proportionate mortality method whereby the observed number of deaths is compared to an expected number of deaths based on a standard population. A proportionate mortality analysis for eighteen RSV 0007563 Page -3- selectcd causes of death was carried out for white males using the age groupings: 20-29, 30-39, 40-49, 50-59, 60-G9, 70-79, and 80+. The expected number of deaths was calculated based on mortality data from the United States Vital Statistics for the years 1955, 1965, and 1973 according to the formula: Expected, = P ** -- P3 Tjk ik s. where Sj* p number of observed deaths from all causes in the jth age group of the study population number of deaths from cause K in the jth age group of the standard population number of deaths from all causes in the jth age group of the standard population time interval Where U.S. death rates were coded to the 8th Revision, conversion was made using comparability ratios to the Seventh Revision. For each cause of death an expected number of deaths was calculated for three time periods 1950-1959, 1960-1969, 1970-4/22/76^using U.S. mortality data from 1955, 1965, and 1573 respectively. The expected number of deaths for the 26-year study period was calculated by summing the expected numbers over time. For cancer deaths, the expected number based on U.S. rates was ad justed for the local death rate using data from U.S. Cancer Mortality by RSV 0007564 Page -4- County: 1950-1969. For each cause of death, a chi-square statistic was calculated between the observed and expected number of deaths where there were at least five expected cases. Tests of significance using binomial probabilities were calculated where the expected number of cases was less the five. All tests of significance were made at the .05 level. Results This study indicates no statistically significant increase in any of eighteen cause of death categories studied (Table 1). Two of these categories which are of particular interest are malignant neoplasms and cardiovascular disease. 2n the case of malignant neoplasms, there were 118 observed and 117 expected deaths (p7-90) There was no significant increase in deaths from digestive cancer with 46 observed and 39 expected (p>.2G). There were six deaths from pancreatic cancer with seven expected (p>.70). There were 318 deaths from cardiovascular diseases when 307 were expected (p>.50). There was one instance within the category of cardiovascular disease which showed a significant increase. There were 237 observed deaths from ischemic heart disease when 203 were expected (p<.025). Discussion When studying - cancer, th<- most representative rates to use are usually the mortality rates for * he local population in the area in which the plant is located. Data for Hampden County are available in U.S. Cancer Mortality by County 195 0"1969{ The Indian Orchard plant employees comprise RSV 0007565 Page -5a very small percentage of the area population and their death rates would most lively be expected to reflect those of the local area. There is no evidence for the alternate assumption that the plant emissions could bias the cancer incidence for the Hampden County area as a whole. There is no significant difference between the observed and expected overall cancer mortality experience. Even though no statistical significanc can be shown, one cannot assume that the mortality experience is equal to that expected. It is only possible`to demonstrate virtually no real difference on a very large sample. With an increased sample size, the probability of determining a difference where there is none would decrease. In addition, the power of the statistical tests would increase and might detect statistical significance not shown here. It is, therefore, important to carefully examine the difference between observed and expected numbers for each of the cancer sites in order to not overlook the differences of possible importance. Three classes of malignant neoplasms need to be considered further: malignant neoplasms of the digestive organs including the pancreas, respiratory system, and genital organs. There were 46 deaths from digestive cancer with 39 expected and 6 pancreatic cancer deaths when 7 were expected. There were 24 cancers of the respiratory system, which is ca.72% of that expected. This is an unusual finding in an industrial population, in which an excess of such cancers are often found. There were 14 deaths from cancer of the genital organs with 9 expected, an excess of ca. 60t, with 12 deaths from cancer of the prostate and 2 deaths from cancer of other genital organs. RSV 0007566 Page -G- Incidence rates for prostate cancer vary considerably with geographic location and other unexplained factors. We are not aware of any esta blished associations of the chemicals handled in the Springfield, Indian Orchard plant with elevated rates of prostate cancer. For certain of these cancer mortality sites with marginally increased mortality proportions, a review of the work histories of the decedents could determine v/hether there is some link in their occupational exposures. If some commonality in exposure history can be established, further study should take the form of a case-controlled investigation. Although there was no significant increase in overall deaths from cardio vascular diseases, there was a significant increase in deaths from ischemic heart disease (p < . 025) with 238 observed deaths and 204 expected. No adjustment was made to determine whether this difference is a reflection ' of a higher local death or a higher rate in assigning ischemic heart disease as a cause of death, as data from Hampden County were not availa ble. This difference may be an artifact of the multiple comparisons made. From the currently available data, it does not seem justifiable to implicate occupational factors in any of the deaths of former workers of the Monsanto-Springfield Indian Orchard plant. The mortality experience of these employees did not differ significantly from that expected in any of 18 major cause of death categories and in the subset analyses of cancer cateaories. ftSV 0007567 Cause of Death with ICD Number (7tia Revision) Observed Expected** Tuberculosis (001-019) Malignant Neoplasms (140-205) * Buccal Cavity and Pharynx (140-140) Digestive Organs and Peritoneum (150-156A, 157-159) Biliary Passages and Liver (155) Pancreas (157) Respiratory System (160--164) Genital Organs (171-179) Prostate (177) All Other and Unspecified Genitai Organs (178-179) Urinary Organs (180-181) ` Other and Unspecified Sites (156B, 165, 170,190-199) Leukemia and Aleukemia (204) Lymphosarcoma, Lymphatic and Hematopoietic Tissues (200-203, 205) Diabetes Mellitus (260) Major Cardiovascular Diseases (330-334, 400-468) Cerebrovascular Diseases (330-334) Rheumatic Fever and Chronic Rheumatic Heart Disease (400--402, 410--416) Ischemic Heart Disease (420) Nonrheumatic Endocarditis (421, 422) All Other Forms of Heart Disease (430-434) Hypertensive Heart Disease (440-443) Hypertension (444-447) Arteriosclerosis (450) Other Disease of Arteries, Arterioles, and Capillaries (451-468) Influenza and Pneumonia (480-493) Peptic Ulcer (540-541) Appendicitis (550-553) Hernia and Intestinal Obstruction (560, 561, 570) enteritis and Other Diarrheal Diseases (543, 571, 572) Cirrhosis of Liver (581) Nephritis and Nephrosis (590-594) Hyperplasiia ol Prostate (610) Symptoms and Ill-Defined Conditions (780-795) Ml Other Diseases (Residual) Motor Vehicle Accidents (E8-10-E835) Ml ether Accidents (E800-E802, E840-E962) Suicide (E9C3, L970-L979) [.cn.icide (964, E980-E985) 0 118 3 46 3 6 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 45 10 16 8 0 3.702 116.720 4.437 39.199 1.520 6.076 33.356 8.769 8.175 .453 6.672 11.674 4.092 6.692 8.002 307.416 ' 44.090 5.503 203.215* 11.066 10.387 10.979 2.24 8' 5.963 8.232 12.997 4.546 .580 1.940 1.096 13.148 3.667 1.337 6.166 16.133 18.554 11.602 3.064 p <TCf5 [~Ch I - S q u a r e = 3.8~42 F 1 RSV 0007568 ** Calculated using statistics from 1955, U.S. white males. Exocctod numbers for adjusted for Hampden Countv, Mass, rates.