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- v/r ' .'t- "7 vvA . Renate >. Kimbrough, M.D. A' --:*>**M? ' , . .aA. &*}. `' . *- - :''A> ^,^'^2 ' - O :*- T>r -'r't/'i- '' ' ^-A?p/ /. ;. ->' A*vv- . " A- .' - Martha Doemland, Ph.D. Mauri^ill^fdig/ Ph.D. -'A} January 1,1946 to June 15,1977 - V. I ' * ''tV'-T. aoNCoO. T-- CO Q STLCOPCB4042061 JOEM Volume 41, Number 3, March 1999 161 Mortality in Male and Female Capacitor Workers Exposed to Polychlorinated Biphenyls Renate D. Kimbrough, MD Martha L. Doemland, PhD Maurice E. LeVois, PhD A mortality study was conducted in -workers -with at least 90 days' exposure to polychlorinated biphenyls (PCBs) between 1946 and 1977. Vital status was establishedfor 98.7% of the 7075 workers studied. In hourly male -workers, the mortality from all cancers was significantly below, expected (standardized mortality ratio [SA1R] = 81; 95% confidence interval [Cl], = 68 to 97) and comparable to expected (SIvlR = 110; 95% Cl, 93 to 129) in hourly female workers. No significant''elevations in mortalityfor any site-specific causemerefound in the - hourly cohort. AU-cancer mortality was significantly below expected in salaried males (SMR -- 69; 95% Cl, 52 to 90) and comparable to expected in salariedfemales (SMR = 75; 95% Cl, 45 to 118). No significant elevations were seen in the most highly exposed workers, nor did SAlRs increase with length of cumulative employment and latency. None of the previously reported specific excesses in cancer mortality were seen. This is the largest cohort ofmale andfemale workers exposed to PCBs. The. lack of any significant elevations in the site-specific cancer mortality of the production workers adds important information about human health effects ofPCBs. From the Institute for Evaluating Health Risks. Washington, DC. Portions of this study were presented in poster form at the 1997 North American Congress of Clinical Tosicoldgy Annual Meeting. September 11-16, 1997. Address correspondence to: Renate D. Kimbrough, MD. Institute for Evaluating Health Risks, Suite 402, 1629 K Street, NW. Washington. DC 20006. ' ' Copyright O'.by Aimefieap pattege of Occupational and Environmental Medicine ; . .. olychlorinated biphenyls (PCBs) are complex mixtures ot` 209 different chlorinated biphenyl congeners. They were used extensively in the United States from the 1930s through 1977 in a variety of indus trial applications. PCB mixtures have several chemical and physical prop erties that'made them extremely ver satile, including resistance to acids and bases as well as oxidation and, reduction; compatibility with organic, materials; and thermal stability and nonflammability. The major volume usage, of PCBs was in capacitors and transformers as dielectric fluids, but they were also used as lubricants and sealants; as additives in paint, plas tics, newspaper print, and dyes; as extenders in pesticides; and as heat transfer and hydraulic fluids. More than 95% of the liquid-filled electri cal capacitors and transformers pro duced before the early 1970s con tained PCBs. PCBs are persistent chemicals and have bioaccumulated in the environment. They continue.ro be detected in air, soil, water, and , sediment. Trace amounts .are also, present in .the tissues of wildlife,- . domestic animals, and. humans;1";; However, the levels .of PCBs in the environment are declining. The potential for adverse human health effects of PCB exposure has been a concern since the early 1970s and resulted in the Environmental Protection Agency's ban of the pro duction of PCBs in 1978. Current knowledge regarding the human health effects of PCBs is limited, inconsistent, and difficult to inter pret. Occupational mortality .studies of capacitor workers Have- reported . '. DSW 189732 i i. i i i STLCOPCB4042062 v. rv STLCOPCB4042063 gmi . -X: mmmmmmmsmm ' %y.r Methodology Assemble the cohort Assure completeness of cohort obtain death certificate e and . *. - . . . is truly alive Results Exposure cto"o>- 00 </) Q STLCOPCB4042064 TCi^ 7*7. '&&#; ;V;x7 t'.7'v*>. V-r^ ;rr^- ']. WWi 77#77-7 "i** *r *'' ' . ' r '' '<+> ``i'fev *. "7' JSJ 1 'r .'/ . . ' *'tf'Ssb/r ' ' : ~ v': , ' ^'7-7''^->*7' 7, '' #i7i : -o** *#*; ' ' . tfe's&g-; . A-;: . -' ' Vv. number v* : . . Correctederiors in electronic file icraonoo (0 Q STLCOPCB4042065 ness Review of pension records 941 Forms = quarterly earning reports _.sUT-:'-'T;A:-\r`-*r%/iti.i'y.*V.:t--*V'''/r . V-.' v-.*-''v .-- -.V^. 'v NationadDeath Index since 1979 , . yjci1- *%. i.. ti}- j'&i)'. O='. v**.;.`hsi.. ?v>v'; - r,;-. j?. &&& ? ".- * ' .>:.{'.-y'*&, / ~'i?K ,- ' .' -V :'r.' [f'f'jzffir ';. ' 7 'T. ' rS'-^&yX- ';*'* .7' *;,s ' ' . ' -V "V- X> ?''Vy^;v 'V .t . Obituaries tapes V* - ` v - r x -1 * . . > > Privateirivestigator -. ' '^..,*71 -K.v'. *` ICs-O Ios CO l o STLCOPCB4042067 DSW 189738 GE pension records Polk directories Telephone directories Private investigator Asking long-term worker > j1v .O ,v/./ jAy'*-'- t?*' . : ;-. :;; '^^VrV'' :' .; .*<*; : . }".y~-:. .. ^ W&i-\ ' .. . - * ";< - - 's' ; V' r . . ' ;c ? ` `` .-. '' < .4 . : v''.^c-Zv.;-.* - - ,, ;>c.';..*& ':' ;-j r ' '. ;;" S^^. -XS^ V, ,'7. ,. ' -` -."*r'': ; 'Z'j'ziffi*'*''; ' '^Nasie Birth Dafe Start arid end dates for each job during e: ........... * Job codes :|P|bbiehiZ^fftcidt to read records) &'*:' ' '* ' ' *'. *'' v/v-'- \: .1.- o> NCO. oOo) CO Q STLCOPCB4042069 STLCOPCB4042070 Demographic Characteristics* Characteristic < Number of workers Number of deaths Number lost to follow-up Mean years worked Number ever highly exposed Number ever undefinably exposed Number ever low exposed Mean years of follow-up Percent attended college Hourly Male Female 2984 2544 586 380 33 52 6.2 5.8 1268 352 2031 133 2343 2468 28 30 15 7 Salary Male Female 1078 469 177 52 73 5.7 4.8 87 10 407 9 831 459 32 34 73 26 TOTAL 7075 1195 (17%) 95 (1.3%) 1717 2580 6101 .;v ' . inclusion criteria: must have worked for at least 3 months between 01/01/46 - 06/15/77. total person years 212,778 STLCOPCB4042071 -v - . 'Sir `f'-C . vv- ... Deaths1 in 2,984 Hourly Males,2 2,544 Hourly Females,3 4,078 Salaried Males4 and 469 Salaried Females5 05 00 (0 Q vfe/V^p;. Sf- p, ' : Ca>w<L9f Peath V Alt Causes , v'/a. fT p;; '-`-i*,'--. `Hourly Males . ;v ^ 0,l?3/B?Rv SMR (95% C.l.) 586 / eRS^-.'aa.S'f (77-91) Females Qfc>S/EXP 380/420 ' ''. ' SALARY SMR (95% C,[.) 90.4* (82-100) Males . gt?s/Exp MR-(9$% CJ,) 177/328 53.9** (46-62) Females Pfrs/E^P 52/75 SMR (95% C.l.) 69.0** (52-91) . All Cancers 128p38-P 8tl*(68-97) 150/136 109 (93-129) , . 56/81 69.1** (52-90) .19/25 75(45-118) Cancer o.f Tongue 1 ^^^.10^(3.576) 2 / 0.4. 483 (59-1745) V 0/0.1- . -- 1 / 0.1 . 1348 (34-7498) Other Cancer of . Buccal Cavity . .. : Cancer of Pharynx, 17^(2^642) 'i..!c'`1Vfivf-i>;.l."*,,:'.-'C';. > .' ., ` ' - ,' 4 /Jfcjfcf* 199-^54-509) 2/0.5 365 (44-1317) 0/0.5 , 2/ 0.7 253 (31-915)' . 0/1.0 "-- -- 1/0.1 . 1021 (26-5690) 0/0.1 -- :. ' " Cancer of , Esophagus^ 5li'My'-r 134(42^04) 1 ' .y* -V^-' '.' v--: ' 1/1.1 87 (2-482) 1/2.0 49 (1-272) 0 / 0.2 -- ' 'yj. r/v ' :P- ..1-1 Cancer of Stomach Qancei; of l.n{eHne 4 L^.9^;.- 68' (IB-173) . 8 />1^0;,; r' ,57 (25-112) . Onhcer-of.Reptum 3/ip-., 87 (16-255) y>0^e^q^i^}/ , , V piassagjesA& Liver ; C9nc^/|Pa;hc;e^sTXs: uG.encerfQf^[_arypX ..A<' LV^.'JArt-'TVX'-iP 2/2>5'v:",,8e|4,0r289) -o'" `.I '/. 9/7A6 / -1.1845^19) 3 / Zip- - .147430:-4'28) 4 / 3.0 20/12.7 4/2,2 2/2.2 132 (36-339) ' 1/2.7 36(0.9-200) 157 (96-242) ,, , 7/7.1 98 (40-203) 169 (46-434) , 3/1.6 - 185 (38-540) 89 (11-321) .. V 1 /1.2 79 (2-439) 7 / 5,9 It0,4 117 (47-241) , 215 (5-1198) 673,9 - 150 (55-327) 0/1.0 -- 0/0.5 1/2.2 0 / 0.4 0/0.3 0/1.1 0 / 0,1 ' 44 (1-247)' ` -- .. . ' --. \ ' , r4- ' '' : A. - a ; -V,-*- -. :-;: .V. -fhi v.;. '<r^h>c:rr-:- A STLCOPCB4042072 -_ :.V: 7 ' Cause of Death ; * -. V- )' . ' .. HOURLY Male.s . 7: Females Qbs/E*6 $MFU85% c,i,) Obs/ExD 3v- Cancer of Trachea, V 7 Bronchus & Lung 42/54,51- ; >7(56-104) 32 / 25.2 Cancer of Breast / . 25/30 . Cancer of Cervix . Uteri : ; Cancer of Other '7-".. Parts of the Uterus - " . ; -4 ... : -- 6/4.7 5/3.8 C Cancer of Ovary, - . - Fallopian Tube, : Broad Ligament ' ' "TT 8/9.3 77'' Cancer of Prostate 12/10.9 110 (57-192) .. , Cancer of Kidney 3/4"- 75(15-219) 2 / 2.1 . ' : Cancer of. Bladder & ; Other Urinary Organs 3/3.8 `77(16-226) 2/1.3 Cancer of Skin 5 / 3.8 ; : 130 (42-303) 3 / 2.0 - ' Cancer of Brain and : . ..' Nervous System 21 5.1 '> V 39 (5-140) 2/3.7 Lymphosarcoma . 2/2.1 92 (11-331) 1/1.5 ; Leukemia & - '. Aleukemia 4 / 6.3 - 63 (17-162) 4/4.3 Other Lymphatic & v Hematopoietic -Tissue 5/ 5.7 . 87 (28-202) 5/4.7 SALARY Males Females SMR (95% C.l.l . Pfrs/EXP SMR (95% C.1.1 Qbs/Exp SMR(85% C,l,l 127 (87-179) ' 12/29.6 40.5**(21-71) 5/4.7 104 (34-244) 82(53-121) 128 (47-277) :- 131 (43-306) ` .- -- -- -- 6/5.7 1/0.9 0/0.6 104 (38-226) 112(3-622) -- 85(37-168) T- 2/1.7 115 (14-415) -- '. 94(11-341) 151 (18-545) 3 / 5.3 0/2.1 1/1.8 56 (5-136) -- 54(1-300) 144 (30-421)' ' 53 (6-192) 4/1.9 4/2.5 . 210 (57-538) 156 (42-398) 65 (2-364) 93 (25-238) 0/1.0 5/3.1 .-- 166 (54-387) 105 (34-245) 4/3.0 131 (36-336) 0/0.2 --. .-- --' 0/0.4 0/0.7 -- --. 0/0.2 0/0.8 -- --. . 0/0.8 -- CM o 00 5c/> Q \ STLCOPCB4042073 '"'Jr. ` <- `'."j-lrv ** ... , ... -v.~ Cause 9fEfrffitfr Diabetes ;. , ; -- -->i'.. tVf' ,, -V v ` * , . 1 }*'*'/'') ' ' _- " */^`V ' Males.} -; ' HOURLY - Obs/fop^ :ME&5%_CJJ - 'if- `A . Afi&JS'Jl:. 3i8* (10-97) Females Qbs/ExD 9 /10,3 .. ';- - . SALARY Males SMRj95%-gid- Obs/Exp 87 (40-1 ei). 5/5.1 Females SMR (95% C.l.) Qbs/Exp 97 (32-226) 0/1.8 SMR (95% C.l.) -- - . vvvj.-V-'Ss'c x *. .- Ischemic Heart . Disease 18' 2- t20':5-'"vv-` 89(76-103) 71/87 81 (64-103) 44) 97.5 45**(33-61) 8/14.3 56(24-110) tiM- Cerebrovascular -1U-. V^-v r . Disease- ', ;' '; ;. . _.;' .. ' 74(49-109) \V> !. S' . -Diseases of Arteries, 19/17.0 . 112(67-174) Veins, Pulmonary ; Circulation- Emphysema ' 7}7.i::' ;96 (39-198) 27/30 10/11 . 3/3.1 89 (59-130) 3/15.2 20**(4-58) 95 (46-17$)V , 4/8.0 50 (14-128) 6/5 120(44-260) 1 /1.8 . 56 (1-310) 97 (20-283) 1/3.3 30(0.8-168) 0 / 0.5 --- . ^2?I;J :y_ -. v,r> -T.'- Pneumoconioses &' ' AS2 (64-145) .other Respiratory ' "riV ,. ` ': ''"*** r*,w, Diseases / - .. .l; . Cirrhosis of the Liver lV/i7-V; :;7^(39-124) 10/11.9 84 (40-154) 7 3/10.2 29* (6-86) 6/9.2 65 (24-142) 3/9.1 - 33* (7-96) 0/2.1 " r7_ir . , 1 /1.7 57(1-318) .1Tra.asportation . -Accidents, 29;/$4;7': 64(56-l20) 14/9.1 : 153 (84-257) 3712.6 24** (5-69) 3/1.9 156 (32-455) flllf: :7 0|l?&r ApCjdents ^yy :`vi?V Suibjde. , W'T^'Vi . i`}:.<'r'- 'Homicide . ftl2???s~ 10/'U.4r ^9>(33-127): 5.7 3.1 - 66(36-110); 3/2 , 31 *.4 ' 96 (7-104) .2/2 158 (51-369) 3/5.9 44(9-128) : " 2/8.6 96 (12-345) . 0 / 3.0 51 (11-1,48) 23* (3-84) '-- 1 / 0.6 2/1.4 07 0.4 169 (4-886) 140 (17-507) ' --- ; - - ' i..;yyi'.:: / i^i^jfitf^fi^at^;<0.Q5; significant ait/P'-fSO.01 ''-- *. V ExD^cVeain u Hi Be rs basod oiiiaersex-race a n -^V^'^7 . ./V' *- ;'*" ^Tv. tr'i"'"; - "`^<K-"; V - '`vl feS'MzSgffii'* .-* rLv.v;J^vr? -!.>*. / o->0 CrOr o 00 5w Q TABLE 9 Observed and Expected1 Deaths for Selected Causes Using Regional Comparison Data in 2544 Hourly Female (75,674 Person-Years) and 2984 Hourly Male Workers (86,056 Person-Years) Cause of Death2 All Causes All Cancers Cancer of Buccal Cavity & Pharynx Males . Observed/Expected 586/713 128/170 HA.2 SMR(95% Cl)3 82.2**(76-89) 75.2**(62-89) 164 (66-337) Females Observed/Expected 380/449 150/152 6/2.2 SMR (95% Cl) 84.6* (76-94) 99 (84-116) 268 (98-583) Cancer of Digestive Organs and Peritoneum 32/45.1 71 (49-100) 40/35.6 112(80-153) Cancer of Esophagus Cancer .... of ' S. tomac h i Cancer of Large . Intestine ' Cancer of Rectum Cancer of Biliary Passages & Liver , 5/4.1 4/5.1 7/17.0 . 3/5.0 3/3.2 120 (39-280) . 77 (21-199) 41.1* (17-85) 60 (13-174) 93 (19-273) 1 /1-5 . 4/3.2 ' 20/16.6 65 (2-360) 124 (33-318) 120(74-186) 4/3.0 , 3/2.6 ' 131 (36-335) 113(23-330) Cancer of Pancreas 9/8.6 104 (48-198) 7/7.2 97 (39-200) Cancer of All Other Digestive-Organs 1/1.8 54 (1-300) 1/1.3 73(2-408) Cancer of Respiratory System 46/64.0 72* (53-96) 34/29.0 117(81-164) Cancer of Larynx . ' 3/2.6 . ; Cancer of Trachea,. ;' V 42/60J . Bronchus & Long : ' " : dancer Mother Respiratory Sites ' < -v 1/0.5. " 114 (23-332) ' 69* (50-93) 185 (5-1033) .; - ; 1/0.8 121 (3-672) 32/ 27.8, . 115 (79-162) ' - i ,* ,* - ,r r . ' -1/0.3 ' v: ;; 273 (7-1519) Cancer of Breast -- . ' :-- 25/31.3 ' 80 (52-118) All Uterine Cancers Cancer of Cervix Uteri Cancer of Other Genital Organs -- -- -- -- '-- -- 11/11.3 6/7.6 9/11.7 97 (48-173) 78 (29-170) 77 (35-146) Cancer of Prostate . 12/11.3 105(55-184) .. -- ' --- - . ; i ` , * ''' \ . v.-, ' '>: /'_( *./. V, DSW 189744 STLCOPCB4042074 TABLE 9 (Cont.) Cause of Death : . : Males Observed/Expected SMR (95% Cl) . . Females , 7 . - v\.r . Qbsetved/Expected , SMR (95% Cl). Cancer of Testes and Other Male Genital Organs Cancer of Kidney . 3 / 4.9 Cancer of Bladder & Other Urinary Tract 3/5.1 Malignant Melanoma 5 /2.5 Cancer of Eye -- Cancer of Central NervoueSystem 2/4.3 . 61 (13-179) 58(12-170) 196(64-458) . --' 46 (5-164) . ' 2/2.9 2/1.8 2/1.5 -- 2/2.8 68(8-245) 111 (13-401) 130.(16^468) -- 69 (8-251) Cancer of Thyroid & .. OtherEndocrine Glands ' . - . ' / --7 .: . ' 1/0,4 / 206(5-1145) ; Cancer of Bone- 1 : Cancer ofAll Lymphatic and Hematopoietic Tumors . 1/0.5. , 11 /16.3 186(4-1035) 67(34^120) v-v 10 / Vi .8 - 84: (40-155). \ Lymphosarcoma & Reficulosarcoma 2/2.7 74(9-268) 2 /1.8 107 (12-385) Hodgkin's Disease Leukemia & Aleukemia "-- 4/6.1 .f 65(18-167) . --- 't . 4/4.6 ' . . -- .. 86 (23-220) Other Lymphafic & Hematopoiefic Tumors 5/5.5 91 (30-212) 5/4.1 ` 121 (39-282) Afl/OtShertotefignabt ... . : 7;V,' .. .v.V -I ' '*:1- ?- J ;;. v''? 77'7 y. j'>:' ? 'V?^- ;'Re%^afef^Disease w Motor VehicleAccidents 6;/9-7 ; 5/8,3 7, ; 60 (.19-139) : '} -v.:v:;-, ; 22$/266.- ' v 94 /144. v4lASf.3 ` a-tv* , '77-314 -' .; w. < " . "r - *' ; } '} ' ' ' '- 27/29:8 9O:;(60-13?l!). V ' /7 14/8.*' V 1 ' 86<57^12S}k , ,7; 167 (91-280) . , All other Accidents' . : . 207%1; ./ ' 'idr(4$-i23); , 97 7.'4 121(55-230): STLCOPCB4042075 <jr }h % . T-V' CONCLUSION , .'v>. In conclusion^ this is the largest cohort of workers directly exposed to PCBs that was assembled specifically for the examination of the association between exposure arid increased cancer mortality. ... Neither overall cancer mortality nor numbers of any of the a priori cancers of interest previously reported as being elevated were elevated in this cohort. ,.. ... [T]he best way to evaluate the validity of a reported association is to replicate the study in similarly exposed populations. To date none of the reported elevations in cancer mortality have been successfully replicated ... [T]he lack of consistent findings with respect to occupational PCB exposure and mortality in studies conducted to date would suggest a lack of an association. Kimbrough, R. D, et al.. JOEM. J999, 41(3), pi70. DSW 189746 `A *;V ' %V** ' 1 t&0\ mmAmWrm ` V ''.. : ^ . pry Committee on the Mortality Study of -General Electric Capacitor Workers #UW- ".-' ' < -" r iigl-?&'" ' _4. ,.;. - -.* r- . . . ;--A< T'QS*^'` ' " '- '.*. ' Rutgers XJi^versity)4 Piscataway, NJ '" * . .`.o;V'-- .*^:$5&^S?>.->-..*-' j*- ,- w?-'>-*i>' .-.'.*.;-'yV ..?: ' :' - - ;?A'1 J 1 ' "- Gilbe^ iV3eel>e, Ph.D. v Na'- Vtio.n. al' Ca;n&I.n.s.ut..--i*/t, u` te,' Beth. es d"a, MD . ,' " *' ... . ' .' ' J.'S'V /-; ..-v#-; v" ' '. . . ''..., Ph.D., M.P.H. Uwvrsit^ Minneapolis . " ; . :. , v*.'.-^<^ *./"... \w -.: :.. ... ' , . ' ' -v;:. sTr'-J1' r ;}., y t-'.Vvs*<i-* *??& D Cfl ' i. ,';''. . ' ^ -J -.'j ,'r tM-'-................ . `A A': 1:'A .. . . -hV^ V- 7 /*= . -r. --.4s rr^..'^. s.O'a*: -A 00 to "n| AA^k y-J, ;' , . v '.v-; ! -' ' r;v , Pli.B. Jr -tyysgyy/y , STLCOPCB4042077 STLCOPCB4042078 * ** ^ ^. .-- -/CV>9-.-'. 'S*'-r'./'-vT <*.\- -..~T {a -'t.; ".jc-.vr' / V . ,.i '' - ^4. / . `\A "-i*/- . '\ v1** (/) 00 C^4*4D. 00 PCBsandCancer: A Summary of the Literature . Author . ,4- :::amm !%y ; Nature of Exposure Persons Person years" All Cancer Obs Exp SMB 1. Zack PCB mfg. 89 ; 1800 8 4.5 1.79 2. Gtistavsson 3. BertazZi ie " . -> "r ' .V Equipment mfg. f i87 ' V -. - . '. Equipment fnfg. 142 2100 (1846) 7 5.4 1.30 41010 26 13.2 1.97 4. Brown - B7 Equipment mfg. 2588 55545 62 79.7 0.78 5. Nicholson ' . ." 6. Taylor v * > "t -V: 4 lee ' s - _ '.. _ Equipment m%. .. Equipment hnfg. : 7. Liss ;: 89 Equipment mfq. , 769 6292 502 NA 44 55.4 0.79 422783 136 144.4 0.94 NA 32 22.6 1.42 | 8. Sinks Tot# Equipment ttlfq. . - V ' ; ,' 3.588 72180 54 63.7 0.85 293318 J88-9 0*95