Document xdaLgoJ85VBLkV5bjJe7OyZ40

BESTCOPYA M llM ll AR13.G-.on 5 P S - 2-- ANTWERP BLOOD TESTING RESULTS FROM JUNE, 1995 1. Purpose of tha Blood Testing Program (BTP) Blood testina for the presence of FC 95 (PFOS) and FC 143 (PFOA) was completed at the Antwerp plant in June, 1995. This was undertaken to eruantitate individual exposures as well as to oain additional insiahts into the mechanism of exposure. Specifically, the following insiahts were obtained throuah this proaram: A. Individual measures of PFOS and PFOA, chemistry profiles, blood counts, and occupational histories were obtained on all participants. (Feedback to individuals has already been done via independent communication. A sample of this letter is included in the information preceding the tables.) B. Areas within the Antwerp facility were compared to one another in terms of individual exposures. C. Comparisons of exposure levels were made to other fluorochemical manufacturing facilities. D. An examination was made of the relationship of fluorochemical blood levels to other laboratory parameters. 2. What was dona This proaram consisted of a medical and work history Questionnaire (see attached)/ blood chemistries (lipid levels, liver function tests, kidney function tests, blood sugar, calcium)/ blood counts (hemoglobin, hematocrit, white blood cell count, platelet count, differential counts), and blood levels of PFOA and PFOS. In addition, for those workers who were felt to have the potential for more exposure blood hormone levels (estradiol, testosterone, LH, FSH, sex hormone binding globulin, cortisol, 17-hvdroxv progesterone, TSH) were also done. Multiple laboratories were used in the analvses. The United Hospital Lab in St. Paul, performed blood chemistry and blood count tests on all participants. Hormones were measured at the University of Minnesota DeDt. of Laboratory Medicine and Pathology. Standardized hormone assay kits were used. These kits were the same kits that have been used previously in coni unction with other testina oroarams in Decatur and Cottage Grove. PFOA and PFOS tests were conducted via 3M*s Environmental Technology Services in St. Paul. The method used in this determination consisted of a standardized extraction technioue develoDed bv Ylinen et. al.(Arch. Environ. Contam. Toxicol. 14:713-717, 1985). This technioue uses tetrabutvlammonium to ion-Dair with PFO and PFOS in serum, and the ion-Dairs are extracted with ethvl acetate. The abstraction was then analyzed usino high performance liouid chromatoaraDhv-thermosDrav mass SDectrometrv. This technioue has been found reliable in orevious testino. Obtainino the medical and work history Dortion of this effort was handled locally bv Antwerp personnel, using the plant physician to translate the Questionnaire from English to Flemish. Employees essentially filled in Questionnaires with assistance from plant personnel. 3. Descriptive results Means, minimum and maximum values are listed in Table 1 for 55 variables. This is a complete listing of variables for which information was gathered. 93 individuals participated in the program. Their average aoe was 36 years. The mean PFOS value The highest waPsFOS1.v83alupoem.wasTh9e.9mdeaont PFQA value was 1.13 ppm. while the highest PFQA value was 13.2 p o t . Comparison distributions for Cottage Grove and Decatur plants is listed in Appendices 1 and 2. Other mean values of interest included an average time worked for 3M of 11 years, an average blood pressure of 125/78, an average of cigarette smoking of 15 years, an average of 9 drinks per week, an average weight of 163 lbs. (74 Kg), an average height of 5 feet, 9.6 inches (176.7 cm), and an average total cholesterol of 212 mg%. Hemoglobin, white blood cell count, red blood cell count, platelet count, liver function tests, and kidney function tests all revealed only sporadic values out of the normal range. Tables 2 and 3 indicate the relationship of PFOS and PFOA levels (respectively) to location of the employees' current iobs. As shown, the highest levels of PFOS were found in workers who currently are in the new part of building 3. Their average PFOS level was 4.03 ppm for 15 individuals. For PFOS, background levels are around 0.35 ppm based on administration and QC lab personnel levels. Building 16 revealed the highest PFQA mean (2.8 d o t for 13 individuals). Background levels for PFOA are around 0.5 ppm in non-exposed iobs. G042S3 This same relationship exists when we examined the lonaest held iob. In this case those DeoDle who had their lonaest job at buildino 3 had the hicrhest PFOS levels (4.45 com for 15 oeonle). Those who indicated that their lonaest held iob was in Buildino 16 had the hiohest PFOA levels (2.88 oom for 14 individuals). In terms of oersonal hvoiene and its effect on blood levels of fluorochemieals, in the Antwerp workers there does not aoDear to be any relationship. There was no sianificant difference in PFOA or PFOS levels in those who washed their hands freouentlv vs. those who washed infreouentlv. Likewise, for those who laundered their work clothes freouentlv there were no differences in PFOA or PFOS levels vs. those who washed their clothes infreouentlv. More frecment skin contact with chemicals in oeneral did not seem to be related to hioher PFOA or PFOS levels. individuals indicated that thev had experienced the followino types and numbers of diseases: Hepatitis A or B. 5 individuals Cancer, tvpe unspecified, 1 individual Abnormal liver tests, 4 individuals Prostatic hvpertrophv. 1 individual Osteoporosis. 1 individual Diabetes mellitus, 1 individual Tables 4A and B are correlation matrices of variables associated with PFOA and PFOS for the entire orouo of workers. This is a preliminary step in the assessment of these chemicals to potential health problems. (The second step of this process is to do multivariate statistical analyses which will be forthcomincr under separate cover.) However, in aeneral, the simple correlations are a aood representation of what will show u p in the multivariate analyses. For the simple correlations, there are three values listed, the correlation coefficient (too), the d - value (middle) and the number of people in the analysis (bottom). For a sianificant statistical association in this settina, a o-value of less than .01 is considered sianificant. As the tables indicate, there were no strona associations with any of the blood test results. There are weak associations (see below) of PFOA and alkaline phosphatase (a liver enzyme) as well as PFOS and creatinine (an indicator of kidney function). In the latter, the relationship shows that with increasina PFOS levels, kidney function improves. The relationship is therefore of no clinical conseauence. ~ 004264 Tables 5A and B are correlation matrices of variables associated with PFOA and PFOS for the crrouD of workers who were felt to have more likelv exDosures. Aaam. there are few associations that are sionificant. Alkaline ohosDhatase is not correlated with PFOA an this croup. which should have more exposure. Included in these tables are the hormone values, some of which have been found to have associations with PFOA in the animal literature. Aaain, there is no strono relationship indicated with anv of the hormone variables. There were, however, weak relationships found between PFOA and trialvcerides (corr. coef.*.48, o.0005). The significance of which is in auestion, since this relationship has never appeared in the medical or toxicoloov literature and is likelv to be a chance findino. 4. Impression Overall, the mean PFOA and PFOS values for Antwerp are lower than Cottaae Grove and Decatur. Also, the maximum values are considerably lower than the other plants. Mv feelina is that exposure in Antwerp is minimal and seems to be under control. Whether this is due to a difference in processincr or to individual hvoiene/safetv practices or all of these is not known. Whatever exposures do take place seem to be focused in buildina 3 (new part) in the case of PFOS and buildino 16 in the case of PFOA. In terms of diseases present in current workers (which represents an incomplete ascertainment) there do not appear to be obvious problems in excess. Neither are there diseases present which would be of concern, relative to the animal literature. In recrard to the blood chemistries and blood counts, these appear to be unrelated to PFOS or PFOA levels. However, there are 9 individuals who have indicated some tvoe of liver problem currently or in the past. This appears to be related to viral etiolocries for the most part. There were no relationships of liver function abnormalities and PFOA or PFOS in the simple correlations. This needs to be further assessed in the multivariable analyses. Likewise, there do not appear to be relationships of PFOA and PFOS to anv of the hormones measured. In terms of the oeneral health parameters of the plant, there appears to be considerable smokina as well as alcohol use. 33% of the participants indicated that thev currently 0042S5 smoke. (This is areiter then the smoking rates in Minnesota, which run around*25%.) 32% of the participants indicated that they have more than 10 alcohol-containing drinks per week (range was 10-42 drinks per week). Smoking and drinkincr rates are clearly higher than in other chemical plants in the U.S. and probabiy reflect European customs to some degree. 5. Racoraaandatione Based on the above information the following suggestions are being made. First of all it makes sense to look further into the processes for buildings 3 and 16, since these had the highest levels of PFOA andPFOS. It would make less sense to look at individual hygiene, since the results were fairly uniformly distributed over the 15 workers in this area. But, this is an option. Of concern would be the possibility of not only respirable exposure but also skin exposure. It would be helpful for the plant to share this information with the work crews and to open up the dialogue between individual workers and the plant physician in this topic matter. Additionally, it has been our practice in the US. to have periodic updates in regard to any important toxicology studies that appear in the literature (human or animal), in an ongoing way. It's important to relay the information that although presumed to be without human health problems, workers need to follow strict safety precautions when working with them, as they would with any potential chemical exposure. A repeat of this assessment should be undertaken periodically. In the US. plants, this assessment is performed every two years. It becomes more of an expected work practice and facilitates future communication with workers. In the US., we are establishing a disease surveillance system for workers in the fluorochemical plants. This is designed to identify diseases in fluorochemical workers that have been described in animal studies. It is used as a mechanism to further enhance our ability to expediently find about these issues, if they do occur. Alternatively, this would also assist us in defending the company against false claims. Although the Belgium regulations may prohibit this, something similar to this would be helpful there. This should be explored in further detail. - 0042.66 The multivariate statistical analyses need to be finalized here before this bro-lect is complete. That should be takinc Dlace over the next few weeks. The additional analyses are not exoected to alter the above comments. This effort will focus on the liver function tests. Drimarilv. One final note. It should be mentioned that the blood aatherina and shipping processes from Antwerp to Minnesota occurred without a sinale error. All tubes were collected and analvzed here without a loss. Additionally, it aooears that the Diant DarticiDation for this effort was the hiahest of anv of the fluorochemi cal exam programs in the recent past. The Deoole who helped with this effort in Antwerp need to be congratulated on a 1ob well done. Please feel free to call either of us with anv guestions or comments that you may have. Jeffrey H. Mandel, M.D., M.P.H. Associate Medical Director Jean Burris, R.N., O.H.N., M.P.H. Proiect Co-ordinator 11/6/95 004267 4 ~'r"r October 10, 1995 TO: FROM: Jeff Mendel, M. D., 3M Medical Department Your blood test for fluorine this year has been completed. Two types of fluorine were measured. The first one reflects FC 143. Your measured level was 2.000 ppm (parts per million). The average for people at your plant was 1.5 ppm. The second results was for FC 95. Your measured level was 4.200 ppm. The average for people at your plant was 1.9 ppm. If your level was greater than 5 ppm, you should check with your supervisor regarding safe handling of these chemicals. We will continue to give you feedback about the significance of the blood levels, from a health perspective. In the meantime, we're recommending that all employees with potential exposure to these compounds use strict safety precautions whenever possible. Check with your supervisors if you have any questions about safe handling and proper protection issues. 0Q4.25S Appendix BEST COPY AVAILABLE Fluorine Test Results Distribution of FC95 Values at Three Locations: Cottage Grove-1995, Antwerp-1995, and Decatur-1994 90% - FC95 3M MtdkiOl Dcteopbaerrtm19c9o5t efi Fluorine Test Results Distribution of FC143 Values at Three Locations: Cottage Grove-1995, Antwerp-1995, and Decatur-1994 Appendix BEST COPY AVAILABLE o* o ^ M y**> t*-* m oMs I FC143 JM MedicaOl DcteopbaerrtmIWea5t O o i\3 *1 O available Antwerp 1995 Fluorochemical Study Mean Vain RWnHTHHSLSHCCDCACSWHFFD'AMDSCeGDCAJonADeCAeYlYYDYYhrmyhiYCCYYdlonuYGiYmeYtYomerYnirAYYkfgOrPvieagLsiaooggdeomLitei19aignnnBknngnateisrngeneenTlnolec/naeanoynTTegontg45assaetkelCMmhtkkBlOgatctosortiBieaiswhl3wnwrstoesowwmrVwhnnMewnitVswwanBltcilenhntattci8woaeolsloitipseeoaoeotlpnoooBofetwooslloncwinotbotdwrrpelrwbrad#oalrtr-oseEgrorePlruoororptiirkrble*okkpeekkgelnk-nesokenrComyrrkkdnrloboesdeelneseueekeeoadedgrepbodreeprgartoodekDdIkd.deCdbdkidedekdrddeaondaelsmdBcshnierrldhneyweeRracaOtrddrtnfpsiBoBcetBodnailelygoldpiddedndhljAullghlpCraplliwdasorixafmedgkadnfdoideareplrDymboyej.igunrmalemsenoinaeLrss.sta.e.edn1obwgbttlsuci33i3naat2ne6oaneserdmMbbsaeairwae*nn-opWwrnlee3aiecdeiollnMdctlwoaildekeyhrpreenjpoummeomhalgnboentkrouraaasgltceeutoelkhaeroidly 999g7C9524SS23S3393671141t11222S21939995I90419N336033i 99999999999999999993393339329222222222223333 11|221912241421114453177246666320545625401002Z41193...1.9.1.15.23392931.661172224.1417355.199.0.4955.3999621(3.4540..47960.015333.40939..49.35.41.6123.9J.2..S619.39..336369.342.376490.9M599.2.1956.3990..3.0391920S.999.60339999099994717026014420341962659214797790400454907510996742169a2113396930231603762517902194e999960930169972602*6406 1f 116_1611200270091000000.00120_..0....0300.00.190.009.000.0.0M10.00..00.100.00..0000..0..900..2.7.0.5000.0.0509.0.000000g00000000502100000007000000i903009000000000103000d000000000000000000000000000000000t000000000w000 m 1219133231322611053340621199300020.......3.3..079.0.0.093000.0060000590000000000000000007000000000000000007000000000 Table 1 1|26392211314221519S611299243242054421667103274401756224031213.102.0.3..2232..33.9.6.2.20.2703917020M.5500302.0.2005141.5210..620.321.1706.0.00.010004990003.0.900..090.0.001.010100..07000.00.60S0.0000.00.0000.00000000000900a0..00.0.00.000.000..000000000001000O00000000020000000040x00000000000000000000000000000700000000030000i000000000000000000m00000000000000000000a 004.271 BEST COPY AVAILABLE Antwerp 1995 Fluorochemical Study ~ All Employees Bar Charts by Department Carnal Dcpartmcat Adala aad BMg I It ft* . *p. Adarialitratlaa Mil* BMg2 WarchovM * * BUg3aad other f*** r*i BMg3, Adaila, Bldg3, Near P O rty^ ^ BMg3.Old ANew BMg3,Old Part Maiateaaact Other QCLab_ plV RADLab,, `V H----- h S.400 O.SOO \----- 1----- h 1.200 1.000 2.000 2.400 IFC9$| ppa Table! H----- 1----- * 4 - 2J00 3JOO 3.000 4.000 6 ifc* BEST COPY AVAILABLE Antwerp 1995 FhiorCocohrcroeii*ctailoSa*tudy --AHEmploye AKPH BUN CCHhoOleLsterol CCrReaEmA DDBireILct Bilirubin GGlLuUcoCse GGOGT. Treni HHDDLL-Qtolamrol ULDLL-C h o k n u u l SSGOOOTT SSGGPPTT Table 4A 00F0.*C010126943263 0.00.4*23992299 00.1.F03C5194993S29 *--- npu-vmslbueer of workers 00.0.9102956202 I 1 II1 0.02.60113119 92 00.0.8115099123 <00.1.21*3914263 00.0.64*294*297 00.0.47*4921229 00.1.21*3913230 00,2.0045*99294 00.0.475*974325 00.0.56267760 92 - 00.0.7400391*27 -00J2.020991527 -00.1.121*979220 -00.1.15359*7226 00.0.643*509124 -00.2.10369*6205 00.0.479209*126 00.0.4*319*1220 00..1901S9*2*0 1I 11j1i I i I i I I I I I I II I1I1I I I I 1 1 1 ]1 11 1 004273 BEST COPY AVAILABLE Antwerp 1995 rinoroCcobrermeltaetaiolnS*tudy --AUEmployee* TTBotIaLl_B_i_li_ru_b_i_n TTrRigJlycerides HHEemMaAtoDloAgTyEPete HHeCmTatocrit HHGemBoglobin MCH MCHC MCV PlLaCteTlet Corn* RRBadCB__lo_o_d_C__el_ls_ WWBhiCte_B__lo_o_d_C__el_ls_ Table 4B 00.F0.C14701374383 00-2.0809933224 -00.1.512971935* __00._0._37_44971352 00.0.5640494134 __0_0.1_.15_35964386 __0_0.0_.56_26596365 _0_0._1._22_42099336 00.0.7500970326 _-_0_.00_.55_76981349 00.0.91027216 93 00.1JF00C799291205 *--npCu-ovmatrlbeuelear_ro_itf_w_c_oor_ek_fef_ri?_ci_e_n_t 0.01.0299968270 00.1.6482963359 00.1.09641570 _____ 93_ ___0_0.1_.16_22901348_ ___0_02_.20_62299322_ 00.0.47746729 _________ __0_.0_2.5_031249313_ -0.11574 ___0_.2_69932_ __0_0.0_.90_73935340_ 002.4091695398 004.274 BEST COPY AVAILABLE-twerp 1995 FluorodbamicCaloSrtruedlayti-onMi ain with Hormone Teating i IH . rr Si Si 1LH Tabic 5A ! 00.F0.C5(071484373 | SO 0.00.F75C3108S9O53S j4-----pnC-uvomarribeueleartioofnwcoonecffeincient I FFoSlHliclemutating hormone 000.844655120 00.1-7242165160 PPRroOlaLcAtinC .4.10.81590S8O43 TThSyHroid mmulenng hormone 00.1.26475S1O90 SSmHBhaGnonnMHlavfiotala 00.0.85646S9O18 CCOorRtiRso1lA -00.105844S41O7 DDHHEEAAS-S 4.01.14118S1O22 HHeTight 4.10S.29638SO38 WWTeight 4.10.04858S2O00 BBModIy Man fader 4.00.(90837S1O3 SYSTOL 00.0.67211613 ___________ I______ 2LL 00.1.32791S1O29 00.106476S0O32 00.106399S43O8 00.1.4064S88O90 j 1 4.10.81890S0O89 i 00.1.407229SO39 400.66928S9O39 4.10706198S3O3 4.00.098581S1O6 I I J I I I 1 1 j 1 |1 j Ij I ( 1 I { 1 1 1 1 1 j 1 j I|1| 004275 Antwerp 1995 Fhrorochemteal Study - Maks with Hormone Testing BEST COPY AVAILABLE Correlations CCIiCsaSr2aaasperday TobkSB 00.F0.C7399I41243421 00.0.F95C23449I$Ii *---pnC*uvomarrlbeueleartoiofnwcoorekfefri*cient ALCSTRT A ft ra ra d dm km i alctatoi ftfuUriy 00.0.7661410739 0.00.5750749179 ALCSTOP Month *o o p n rt* lu m K o h o l -003.27371649 00.9.036546440 DArLinCkP*/WwKdcPwben were dnnkm* -00.1.5012433302 00J.6001247376 ALCPWKNW D n tiB ^ v n k mpw -00.0J1U049576 00.13114541472 DALriCnk3) per day -0.00.761446079 00.1.19S545259 EESstTraRd.iol 00.13331151900 00.0.9066544055 %TEFSrTePeCTestosterone -00.05162155509 003.0194145906 TTEesStToeTtsnae (Total) TTeEsSto7sFterone (Free) 003.1153652106 003.6006657106 00.1.4124155500 -00.0.6501557305 1*17 00.1J3S4235207 0401.66704S9O23 CQ4276