Document 8xV9eG9EMye0MQvKvZrJQY5d

Corporate Health Physics CCoorrppoorraattee POrcocduupcattiRonesaploMnseidbiicliintye Corporate Toxicology 3M Medical Department P3SOMt. BPCaoeuxnl,t3eM3r2,N2202505-213E3-0-32220 651 733 1110 mu Fluorochemical Control Study This is a report of a cross-sectional correlation analysis of medical surveillance data collected in 1981 of Decatur chemical and film plant workers and their total organic fluorine levels. There were no statistically significant correlations reported between SGOT, SGPT, GGT, alkaline phosphatase, total bilirubin, red blood cells, hemoglobin and cholesterol for either the Decatur chemical or film plant workers. The report was reviewed by Dr. Leonard Schuman, Professor and Director of the University of Minnesota Division of Epidemiology Department (letter attached). Although this report does not specifically mention perfluorooctanesulfonate, it is submitted as it chronologically followed the 3M Technical Report that observed perfluorooctanesulfonate was a component of total organic fluorine in the sera of 5 Decatur employees. 001713 i To F. A. UBEL, M.D. - MEDICAL DEPARTMENT - 220-2E-02 From D. E. ROACH, M.D. - MEDICAL DEPARTMENT - 220-2E-02 Subject Fluorocheraical C ontrol Study Date May 25, 1982 TMcoinohpimeentrnupraelretesnvitooieetndarwe..sv. ioeSfwItnetadhteaisdin1tdi9ic8ttha1ioel nDaD,enectapahlateyurtsrmcisofelnnuwtcoalruososfcpiohEenerpfmsiodrieamcnmaedlidosclobtogyanyttRirsaoittkliectsrhatueRldeyUasnenhaaiarlvycsehsrebssDeietaynwtaeoref wnewtbiTiPnnhmueholomtaierrpwskttnkblhheotpeeeweryhurenseeriivCmepsst hiwttothepuwoisieewnldneoorrmye.iyeitt.poechhsfoefaeee.PslpAtluahFctwPlrlhTtiiaalthltsaeishtmoocimneouiotspingbnPDtcuaheaaledntagalcidyanproaopdvtatnu3ewulorapg0qrtlanb6uisruscoyptnauiat(tltpoesowpabasanuroauytwsfctttmihoooibeomrrstnehdtafimphstsaeew6mtotiroa0vseaoweF.0strdbie)cialselsemot3tifrhnirw1astocaa7iPemmnatilrlhnoaleietmngtilhhnaebtipFricvrllseoataoiahleoneyllmdedcuxemosecaFptseecntohiipllhtnolaeert(metnoncohm.CltustfioPithosgthrleotnAraormiooystnnfhkuityftcopo1tea*epr.trli5hysra0et)rssot ef pbTselhhovoeoessdeprahcplaeottalpelsuselct,aotGiruoeGnnsTtsu)P,l)wt,sceshroesomulcecehosmhtaeepsmraoraleltid,ovleoawngridythenlpazrayesrmast lmpeyseecto(etS'rrGgstoOan(Thti,hcemeSGfoldPguTilosoartbriliniknbeaualintlniedoevnreeldso.f ttsPIhonilgoat asnnseultimf ibaomcnlroaadgornaydtnt,hicotcwesoeesfrltrfuoeinuorlanerdtitsinhuoeenln.otsFbsilbeimgtewtnwePieeflneiacnnatthneemctsopednloittfyrefoeeselrstegnwrrcoeoeusrpuk.iilnntsg Tt haihnneedr etdhbiewlsotaorCsidhbaeullmest iovioceannllso of o f Taoruheresueflnuaroebrsloeuclhttoesmdfiuecmartlohneexsrtprocasoteendfiervemmidpeolnuocryeeceosli.fn iicllanle sism porresdsiiosenasteh apt attote rdnaste amweong aahEojnep-fdeafpolotsarhrtnttrsyuuencvQsithatuuiolereuuessaltdtiiootoonfcnossth,nhetiwpilsnpleiulaepllosrowebigneercracrameboldllno.uitosicndiunpegfrdleuseomeonrnpitnllaoyeyerueleengvdeuxeelarplsro.rsebuvraieFseoiwsll..ow -TIufimptihngere H,,F.^r/?cr 001714 1 uorochemical Control Study P o p several .years health evaluations have been conducted at two major chemical plant production sites. The purpose of these evaluations 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 fluorochemicals and (2) to the presence of these fluorochemicals in the blood of the workers. To date no pattern of disease has been identified. However, two additional studies had not been performed. One was the collection of total blood organic fluorine levels on chemical plant employees. The other was to develop a suitable control. Roth of these became available in 1981. The control study was undertaken at a plant site with two separate divisions represented by two manufacturing sites located approximately 500 yards apart. All were 3M production employees and the mobility of the employees between the two sites was relatively low since two separate manufacturing divisions were involved. One objective was to compare the incidence of abnormal values of certain blood tests seen at each plant. Those tests to be compared were: 1. SGOT 2. SGPT 3. Alphaline phosphatase 4. GGPT 5. Cholesterol 6. Hemoglobin 7. Red Rlood 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 blood organic fluorine. The chemical plant employs approximately ^50 people. These employees take part in a general health evaluation annually which among other things includes a chemistry profile and a C B C . Participation in the health testing is voluntary. The testing is done aboard a commercial testing van which regularly visits the Joint plant site. 001715 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 levels 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 and were almost.entirely production workers. Within this group any'employee Identified as having worked in the chemical plant for over three months were removed from this group creating a subgroup of 210 solely film plant employees. In summary, the blood fluorine samples were handled differently between the two plants. Otherwise all blood testing 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. 001716 PRELIMINARY DATA ANALYSIS "ABNORMAL" LIVER ENZYMES FILM VS. CHEMICAL PLANTS LOCATION CHEMICAL FILM FILM MINUS WORKERS IN CHEM PLANT > 3 MO NUMBER TESTED EMPLOYEES WITH 1 OR MORE "ABNORMAL" ENZYMES 327 306 37 (11.3%) 26 (8.5%) 210 20 (9.5%) NUMBER ABNORMAL TESTS GGTP SGPT ALK. P'TASE 2A (65%) 11 (30%) 6 (16%) 12 (46%) 9 (35%) 7 (27%) 10 (50%) 7 (35%) 3 (15%) % OF ALL TESTED WITH ABNORMAL: GGTP SGPT ALK. P'TASE (7.3%) (3.4%) (1.8%) (3.9%) (2.9%) (2.3%) (4.8%) (3.3%) (1.5%) IF GGTP REMOVED FROM ALL TESTED % OF PEOPLE WITH "ABNORMAL ENZYMES" 5.8% 6.9% 7.1% i' < 001717 - 3 J V c!>.r fZ'.'h*, it yoc '"h L / * i ; 2-QU bj CORPORATE MEDICAL CORRELATIONS BETWEEN LIVER VALUES AND FLUORINE 1 1 DECATUR FILM WITHOUT 1 LIVER TEST 1 DECATUR FILM 1 CHEMICAL WORKERS 1 DECATUR CHEMICAL SOOT 1 .00596 1 .9191 1 SGPT GGTP 1 -0.02662 1 .64 75 1 Hi 1 -0.07622 1 .1940 1 ALKPHOS 1 -0.01766 1 .7630 z'n TdlLI RBC HUB CHOLESTEROL 1 -0.05636 1 .3355 1 ?. `i i 1 -0.09570 1 .1U15 1 _/ `i f 1 -0.08624 1 .1402 1 2 '11 1 .03607 1 .5378 1 1L 'f<-/ 1 .03647 1 .6109 ! fV 1 -0.08539 1 .2328 j /?7 1 02044 1 .7756 1 I e! 7 -0.05440 1 .4477 \ ) cn 1 -0.0575 1 .4800 ! __________ 1 .09358 1 .1909 ! /7 7 1 -0.05869 1 .4621 ! n? 1 -003366 1 .6367 ! l ((7 i -0.00369 1 .9509 \ ..iiv _ 1 .02925 I .6632 _____!.. ! l\ i I -0.03291 1 .6462 1 i cM \ -0.01872 1 .7946 1 ni. 1 -0.01737 1 .8086 ! - j <n -- - - I .04051 1 .5720 i -0.01159 1 .8719 !. 1 u 1 -0.07620 1 .2872 1 /7 ------ _ _ L L Z ------------- NOTE: f i k s t v a l u e is c o r r e l a t i o n b e t w e e n l i v e r test and b l o o d f l u o r i n e SECOND VALUE IS THE SIGNIFICANCE PROBABILITY OF THE CORRELATION 001718 corporate medical correlations between liver values and fluorine CALCULATION INVOLVE ONLY EMPLOYEES FROM CHEMOLITt HAVING 1981 HEP EXAMS LIVER TEST SGOT 1 ! CHEMOLITE 1 01811 1 .7740 1 b(sP T .10291 1 1 . l O*J i GOT p 1 .06442 1 .3084 1 ALKPHOS 1 .12979 .0395 1 TdlLl .-t rfC 1 -0.10845 1 .0858 i 1 -0.08738 1 .1693 1 Hob 1 -0.04083 1 .5214 1 CHOLESTEROL 1 .12222 1 .0526 1 AGE 1 .08278 1 .1859 1 NOTE: FIk ST VALUE IS CORRELATION BETWEEN LIVER TEST AND BLOOD FLUORINE SECOND VALUE IS THE SIGNIFICANCE PROBABILITY OF THE CORRELATION 001719 UNIVERSITY Of- MINNESOTA I//IN f l l t '3 M m iiO.ipulib. M irm esolrl 55455 fipK ./ U :rd April 29, 1982 ^ r . Frank Ubell Medical Director Medical Department, Medical 220-2E 3M Center St. Paul, MN 55144 Services Dear Dr. U b e l 1, I recently had the opportunity and the privilege of examining the protocol for and the data from the studies undertaken by Dr. Roach of your department on fluorochemical exposures in one of your chemical plants with a control population drawn from a film plant under your jurisdiction. I was provided with information on the size of the respective plant populations, the extent of their partici pation, the clinical laboratory tests on several blood parameters, the intervals of testing for blood fluorine levels, the disease patterns in these populations and the data derived therefrom. I was impressed with 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 partici pation in the health testing was voluntary the response in the chemical plant was high as would be expected (317 out of 450). (The partici pation in the health evaluation was even higher.) Participation in 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 examining the distributions of the results on the clinical chemistry noteworthy were the similarities among all the groups. Although fluorine levels revealed increases, correlations with the clinical tests were insignificant. In the absence of any disease patterns elicited by history and clinical examination and the general similarities in the distribu tions of such test results as for SGOT, SGPT, alkaline phosphatase, GGPT, cholesterol, hemoglobin and red blood cell counts, one must conclude that virtually no evidence for even pre-clinical toxicity 001720 Dr. Frank Ubell April 29, 1982 page two exists. Compartmentalization of the data on a spectrum of length of exposure and blood fluorine levels, although a refinement, would probably y i e l d little or no additional information since the N's in the strata would be reduced to inadequate levels for significance. Continued clinical followup on an annual basis with a view to eliciting possible chronic fluorocarbon toxicity would be feasible and worthwhile in your setting. Thank you for permitting this appraisal of your protocol and data. Sincejcely yours, LMS:sn Leonard M. Schuman, M.D. Professor and Director 1 001721