Document qm06a6rqEQEwQmrNZo6jgOKDK

Corporate Health Physics Corporate occupationalMedicine Corporate Product Responsihility Corporate Toxicology 3M MedicalDepartinent 3M Center,220-2E-02 PO Box 33220 St.Paul,MN 55133-3220 651733 1110 FluorochemicalControlStudy Thisisa reportofa cross-sectiocnoarlrelatiaonalysiosfmedicalsurveillandcaeta collecteidn 1981 of Decaturchemicaland filmplantworkersand theirtotalorganic fluorinelevels.There were no statisticaslilgynificanctorrelationrseportedbetween SGOT, SGPT, GGT, alkalinpehosphataset,otalbilirubirne,d bloodcellsh,emoglobin and cholesterofloreithertheDecaturchemicalor filmplantworkers.The reportwas reviewedby Dr. Leonard Schuman, Professorand DirectoroftheUniversityof NfinnesotDaivisionofEpidemiologyDepartment (lettearttached)A.lthough thisreport does not specificalmleyntion perfluorooctanesulfonaittei,ssubmittedasit chronologicallfyollowedthe3M TechnicalReportthatobserved perfluorooetanesulfonawtaes a component of totalorganicfluorinientheseraof 5 Decatur employees. 10 F- A- UBEL, M.D. MEDICAL DEPARTMENT FIM D. E. ROACH, M.D. MEDICAL J@EPARTMENT sObJecl*Fluorochemical Control Study Dale: May 25, 1982 220-2E-02 220-2E-02 Tchoemprleevtieedw.oSftattheis1t9i8c1aDlaencaaltyusrifsluorochemicalcontrol study has been operations. In addition, vag performedby Riker ]ResearchData In turn reviewedin the Dethe conclusionsand statistical&naly.8es were Minnesota. Partment Of Epidemiology at the Universityof The Purpose of this between two POPulatistudy was to compare certain blood chemistry tests on groups assumed to be similar except for their work histories. The Decaturplant site was a logicalselectionfor this review. Participationby both the Film Plant and the Chemical Plant employees was On a voluntary basis* 31T employees (out of 450) in the Chemical Plant and 306 (out of 600) in the Film plant took part in the study. Althoughparticipationwas lover in the Film Plant these numbers were felt to be adequate for statisticalevaluation. Any employee in the Film Plant group with more than three months history of work within the chemicalplant was removed from this control group. These populations were comparedwith respect'tothe distributionof several test results such as liver enzymes (SGOT. S(;PTalkaline phosphatase. GGTP), some hematology-Parameters (hemoglobin and red blood cell count),cholesterol,and lastlyorganicfluorinelevels. .In sumMrY, we found no significantdifferencein the distributionof those blood test results between employees working in the Chemical Plant and those In the Film Plant control group. There was also no stiogtnailfoircgaannticcofrlrueolratiinoen.between these test resultsand blood levels of These results further confirmour clinical impressionthat to date we are unable to demonstrate evidence of illness or disease pa".ternsamong our fluorochemical exposed employees. Ffforts should continue in reducing employee exposure opportunitiesto help lover blood fluorinelevels. Fol'ow--,ip health evaiiiationwsill be continued on a regular basisL. Timing and structureof this program is present'Lyunder review. If there are elnyauestions please call. .)FP/cr PI.P.jr)r(-)chemircoRnltrol Stuiy Pot, several years health evalitations have been conducted at two major chemical plant production sites. The purpose or these evaliiations was to determine whether or not any patterns of disease could be detected that might be related (1) to the exposure of employees to certain fluoroebemicals and (2) to the presence of these fluorocliemicals in the blood of the workers. To date no pattern of disease has been* identified. Y4owever, two additional studies had not been performed. One was the collection of total blood organic fluorine levels on chemical plant employees. control. The other was to develop a suitable Both or these became available in 1981. The control study was undertaken at a plant site with two separate divisions represente(f by two manufacturing sites located approximately 500 yai,ds apart. All were 3M production employees and the mobill.t.yof' the employees between the two sites was relatively low since two separate manufacturing divisions were involved. One ob.iective was to compare the incidence of certain-blood tests seen at each plant. compared were: of abnormal values Those tests to be 1. SGOT 2. SGPT 3. Alphaline phosphatase 4. GGPT 5. Cholesterol 6. Hemoglobin 7. Red Blood Count "Abnormal" was to be any variation from normal despite clinical assessment. Another objective was to see if there was a correlation between these blood test results and the levels of total bloo(I organic fluorine. The chemical plant employs approximately 450 people. These employees take part in a general health evaluation annually which among other things includes a chemistry profile and a CBC. Participation in the health testing is voluntary. The testinx is done aboard a commercial testing van which regularly visits the joint plant site. Total organic fluorine blood tests were drawn separately in the nursing department throughout the year at this Chemical Plant. These tests were spaced over 1981 and were sent to St. Paul for the analytical determination. The variations In organic fluorine level's changed slowly due to delayed excretion. Therefore, although not drawn simultaneously with the chemistry profile this was not thought to be a major inaccuracy in the comparison with the chemistry profile. 317 employees participated including several office personnel. The Film plant employs approximately 600 people and had not previously been involved either in health evaluations nor in organic fluorine blood testing. Here again participation was voluntary. These employees were tested in a random manner and interspersed among the chemical plant employees on the van each day. In addition blood fluorine samples in the Film group were also drawn on the van following the same protocol as when drawn in the nurses station. The blood fluorine samples were then taken promptly to the nurses station for centrifuging, packaging and deliver to St. Paul as Is the normal routine. 306 employees participated rand were almost. entirely production workers. Within this group any-employee identified as having worked In the chemical plant for over three months of 210 solely* wefrielm rpelmaonvted from this employees. group creating a subgroup In summary, the blood fluorine samples were handled differently between the two plants. Otherwise all blood te*sting was felt to be identical within both groups. The three groups to be analyzed were: 1. Chemical Plant employees (317) 2. Film Plant employees including approximately 33% of people who at one.time had spent some time in the chemical plant (306). 3. Those film plant employees who had essentially no previous exposure to the chemical plant (210). The attached results and statistical analyses are attached. PRELIMINARY DATA ANALYSIS "ABNORMAL" LIVER ENZYMES FILM VS, CHEMICAL PLANTS LOCATION CHFJ-11CAL FILM FILM MINUS WORKERS IN CHEM PLANT >3 MO,' NUMBER TESTED EIIIPLOYEESWITH 1 OR MORE "'ABNORMAL" ENZYMES NUMBER ABNORMAL TESTS GGTP SGPT ALK. P'TASE % OF ALL TESTED WITH ABNORMAL: GGTP SGPT ALK. P'TASE IF GGTP REMOVED FROM ALL TESTED '/"OQF PEOPLE WITH "ABNORMAL ENZYMES" 327 306 37 (11.3%) 26*(815%) 1210 20 (9.5%) 24 (65%) 11 (30%) 6 (16%) 12 (46%) 9 (35/wo) 7 (27%) 10 (50%) 7 (35%) 3 (15%) (7.3%) (3.4%) (1.8%) (3.9%) (2.9%) (2.3%) (4.8%) (3.3%) (1.5%) 5.8% 6.9% 7.1% c).4.r AMbi, CORPORATE MLDICAL Ci.Ircr?ELATIONSBETWEEN LIVER VALUES AND FLUORINE I VECATUK FILM WITHOUT I LIVER TEST I E)ECAlUk FIL@I I CHEMICAL WORKERS I UECATLIR CHEMICAL ------------ I -------------- I ----------------------I ----------------- S60T 1 100596 1 o03647 1 -OoOdS39 ------------ StiPT 1 19191 1 06109 1 :27.3 1 1'17. I -------------I.- 1 -0*02662 1 oO2O44 1 9232u 1 l@7 I--. ------------1 -OoOS4 40 ------- 1 6475 1 o7756 1 94477 ;jl -------------- I / Ci7 1 ) el 7 --------------I----. ------ GGTP 1 -0907622 1 -o.o575 1 -0900369 1 1940 1 o4800 *95b9 ALKPHOS TDILI Rt$C HUB ------------------ ------ 1 -0*01766 1 oU935d 002925 1 .7630 1 *1909 I ;L(I-i I Ift7 I -------------lm-. o6632 --------m----I --- ------- I -OeO5b36 I -0,05eb9 1 -0903291 1 e3355 1 *4621 1 ob46a -7---------------- 1I---(-1--7------ 1 -0.09570 1 -0,03386 1 -0*01872 1 *1015 1 ob367 I .794b lr7f il(------------ 1 -0*08624 1 *1402 1 -Uool7j7 1 oboub -0.01159 *8719 ------ CHOLESTEROL 1 .03607 1 *5378 ----------- 1 *04051 1 95720 -.j 'LL----------- 1 -0*07620 1 *2872 ------------ --------- ---- -- -- --- - NUTE: FIRST SECOND VALUE VALUE IS CORRELATION BETWEEN LIVER TEST AND ULOOD FLUUHLNL IS THE SIGNIFICANCE PRUbAbILITY OF THE CORRELATIUN CUKPORATE MEDICAL CORRELATIONS BETWEEN LIVER VALUES AND FLUORINE CALCULATION INVOLVE ONLY EMPLOYEES FROM CHEMOLITL HAVING 1981 HEP EXAMS I I LIVER TEST I CHEMOLITE ------------ -------------- S Li(iT .01811 1 *7748 ------------ -------------- -SUPT 1-.10291 1 01031 ------------ -------------- GtiTli I oOb442 1 3084 ------------- -------------- ALKPHUS 1 *12979 1 *0395 ------------ ----------- TdlLl 1 -0.10845 1 1 .0858 ------------ -------------- .-(dc 1 -0*08738 1 1 .1693 ------------ -------------- tlob 1 -0*04083 1 .5214 ------------ -------------CMULESTEROL 1 .12222 1 .0526 ------------I -------------- AUE. 1 .08278 1 1 eIB59 ------------ -------------- NUTL: FIKST SECOND VALUE VALUE IS CORRELATION BETWEEN LIVER TEST AND BLOOD FLUORINE IS THE SIGNIFICANCE PROBABILITY OF THE CORKELATION LJNIVERc;1Y7C)FMit4NtS,ol'A -;:,I")Iel-;vi.-cIifio,-e-St?Ei t.iiiii,e.jMpiurlilr!i,e.sol5i5455 APP April 29, 1982 Frank Ubell Medical Director Medical Department, Medical Services 220-2E 3M Center St. Paul, MN 55144 Dear Dr. Ubell, I recently had the opportunityand the privilege of examining the protocol for and the data from the studies undertakenby Dr. Roach of your department on fluorochemicalexposuresin one of your chemical plants with a control populationdrawn from a film plant underyour jurisdiction. I was providedwith informationon the size of the respectiveplant populations,the extent of their'participation, the clinical laboratorytests on several blood parameters, the intervals-oftesting for blood fluorinelevels,the disease patterns in these populationsand the data derived therefrom. I-was impressedwith the care taken to avoid bias in collection and testing of the blood samples and the insight and sophistication of the data analyses by Hawkinson and McCormack. Although participation in the health testingwas voluntary the response in the chemical plant was high as would be expected (317 out of 450). (The participation in the health evaluationwas even higher.) Participationin the control plant, although lower (306 out of 600), was deemed adequate for control purposes. Those controls who did have earlier exposure of 3 months or more were properly set apart as a separate subgroup. In examiningthe distributionsof the resultson the clinical chemistrynoteworthy were the similaritiesamong all the groups. Although fluorine levels revealedincreases, correlationswith the clinical testswere insignificant. In the absence of any disease patterns elicited by history and clinicalexaminationand the geniralsimilaritiesin the distributions of such test results as for SGOT, SGPT, alkaline phosphatase, GGPT, cholesterol, hemoglobin and red blood cell counts, one must concludethat virtuallyno evidence for even pre-clinicaltoxicity Ur. Frank Ubel 1 April 29, 1982 page two exists. Compartmentalizationof the data on a spectrum of length of exposure and blood fluorine levels, although a refinement,would probablyyield little or no additionalinformationsince the N's in the stratawouldbe reduced to inadequatelevelsfor significance. Continued clinical followupon an annual basis with a view to eliciting possible chronic fluorocarbontoxicitywould be feasible and worthwhile in your setting. Thank you for permittingthis appraisalofyour protocol and data. Sinc5ep!lyyours, ip /@ LMS:sn . eonard M. Sc6uman, M.D. Professor and Director