Document jBKzMmM1ebnabQMavpM4mwXgO
32
Asbestos Air Pollution o
Laboratory. The following table gives the range of values ob tained from quarterly composites of biweekly 24 horn- samples.
Chrysolite asbestos content of ambient air samples collected by NAPCA in 4 9 United States cities.
Fiber rang'e Oj,n nnuograr.`*V m
0.1- 0.9 1.0- 4 . 9 5.0- 9.9 10.0-19 20 -4 9 50-1-
No. of samples in
6i 102
12 9 2 1
Total samples
187
Results were also obtained from a series of single 8 hour samples collected in New York City by the Doperement of Air Resources at 1? sites of their sampling netv/oik.
Chrysofjle content of ambient, air in Ne.v York City by borough
8amp]i ng Local ions
Number of Asbestos a:
Sain pic* s
Range
~y s level in 10 grain s/m
Average
Manha 11 an Lrooklyn lironx Queens Staten Island
7 3 4 4 4
8-65 6-3 9 2-25 3- 18 5-14
30 19 12
9 8
Sampling about construction site'- where extensive spraying of asbestos-cont ruling lirepi oof jng materia.! was taking place shows this procedure to contribute* significantly to asbestos air pollution. In soi ie instances chrysoti lc asbestos levels approximately 1U0 time "background" were observed.
Chrysolite asbnsl os concent r :*tions near spray 1Joe pi;iofing si its
Sampling Local!on Number of Sample:,
Asbestos /iir J/.V'l 7^
in 10 `fcVw
Range
Average
1/8-1/4 mile 1/1-1/2 mile jl/ 2- 1 mile
11
6
5
9 -375 8 - 54 3,3 36
GO 25 18
3j
, Asbestos Lung Burdens
Examination of human tissues nay provide information as to the in tensity of fiber exposure; fiber type (involving mixed exposure); fiber distribution; and fiber alteration in vivo.
The amount of tissue examined in the search for asbestos fibers is related to the degree of exposuie (occupationally exposed vs. the "general population," or "noil-exposed") end the materials avail able for study. Little material is required for the identification of libers in tissue from Individuals with "hot vy" asbestos exposure. Here, histologic, sections are quite adequate. However, in cases where small amounts of asbestos are likely to be encountered, bulk tissue will significantly incrcaa fiber yield, greatly reduce Lime of fiber search, and yield results with increased statistical validity.
Histologic sections may be prepared for fiber analysis by a number of methods. The technique selected is based upon the type of in strumentation which will be used in fiber localization and iden tification. The following technique is now used routinely in the preparation of tissues for examination wild) electron beam instru ments; it is called the carbon-extraction technique (Pooley, 1972; Lunger, ot a], 1972b). The preparation involves:
1. tiie ashing of a 5-8 micron thick, unstained, histologic section mounted on a glass si.ide;
2. impregnating the relict tissue in a watcr-soluble plastic (poly vinyl alcohol);
3. "peeling" the hardened plastic, and the incorporated ashed tissu from the slide;
4. inverting the relict tissue and depositing a thick carbon coat onto the inverted surface;
5. dissolving the plastic from the carbon sheet (which no'-' includes the relict tissue and the inorganic particles'*, and;
6. placing the carbon film onto approprj ate rubrtraxes for examina tion in an electron beam in si runout (EM copper locator grids arc. bust for this purpose).
The bulk tissue technique is the KOii digestion method as outlined
in Langur, et ;d (1971)
'
1. Dried lung tissue j digested in a 5V. k()H solution wh ilc being heated at 90 C for a 4-hour period;
2. Several eye les of washing and <eni j jiugat ion of the residue are required tor ihe com pi etc rcncr. ai a l digt. :d nuitoj ialr and the KOII;
Lung Burdens - 2
3. The residues are then dispersed in triple-distilled water by Bonification and a small amount pipetted onto an appropriate electron microscope substrate.
4. After drying, the grid is scanned in a transmission electron microscope at a magnification of 42,000 X, The scan is made across the diameter of the field and the fibr density con verted into mass.
The major advantage in using such a method is the concentration of particles from masses of tissue greatly in excess irom what one would normally encounter in a histologic slide. The major dis advantages are the oin.e required for a single specimen scan and the instrument commitment to such, an analysis.
Some e stimates of_lung burden have been m a d e . In one study of lung residues obtained from 28 people who died in New York City we estimated that their lungs contained chrysotile concontratj ons on the order of miurograms to tenths of milligrams quantities (several hundreds of ' millions of fibrils). However, that study produced conservative estimates on the basis of technique of preparation (sample loss) and enumeration (direct on Eli screen) , in another study ot 100 additional cases, fi oni the "general population," a more controlled procecut e produced lung burden estimate's which e iceed several 10 1s of mill .grams. he have compared these values with those obtained in the ana Lysis o.<. tissue:- iron vorkmen exposed to asbestos occu pational] y. Here the number of fnheis per lung is on the order of hundreds of billions, and the eeleul tr ed mass may be as high as 5 g u V J w g . Indirect oecuput tonal exposure to fiber results in lung burdens lying between the general pop.-il ation and occupational exposure levels.
Some observations of importancc a r c :
1. Histologic sections are adequate for p;rticle evaluation in cases of inten.se exposure:: however, bulk ti trues give best re sults in cases from th^ general population.
2 . Exposure intensities m ay be qualitatively evaluated in unknowns.
3. Sub-light microscopic fibers far exceed those scon by light micros copy in nunh&r in nil eases and tissues studied thus far. .
4. Asbestos bodies, objects visible by light mi ero.scopy and often user) as, ,m ami ex of rsbi st os exposure, only partially and onl y in some occupational cases reflect the lung burden of asbestos.
5. Chrysoti1c asbestos js the most common sub-light microscopic
m
Liber in hum an tissues, most- often, occurring in 1he fibril form.
J> ii
References
Lung Burdens 3
Longer, A . M . , 1970, Electron micropiobe analysis (study of asbestos fibers and bodies from lung tissue): In Laboratory Diagnosis of Diseases Caused by Toxic Agents, F.W. Sundcrraan and F.W. Sunderman, Jr., Eds., IV.H. Green, St. Louis, Mo., Chap. 14, p. 12G-136.
Langer, A . M . , Rubin, I.B . , and Selikoff, I . J, , 1972, Chemical character ization of asbestos-body cores by electron micruprobo analysis: Jour. Histoehenu and Cytochem. , v. 20, no. 9, p. 723-734.
Langer, A.M. , Rubin, I.B., Selikoff, I.J. , and Pooley, F.D., 1972b, Chemical c h a r a d crization of uncoated asbestos fibers from lungs of asbestos workers by electron microprobe analysis; Jour. IlisLuehem and Cytochcm., v.20, no. 9, p. 73 5-7 10.
Lange.' , A.M. , and Pooley, F.D. , 1973, Identification of single asbestos fibers in human tissues; In Proceed] ngs Inti. Agency for Res. on Cancer; Biol. Effects of asbestos, Lyon, 1972, C. Wagner, Id. , Paper 19, in press.
Langer, A.M:., Selikoff, T.J., and Sastre, A., 1971, Chrysotile asbestos xn the lungs of persons in New York City. Arch. L nv . Health, v. 22, p. 348-36].
Langer, A.M,, B,-de n , V. , H am mo n d, K. C. , and go] jkoff, I.J., 1971, Inorganic fiber's, including chrysotile, in .lungs at autopsy: preliminary report : In Inhaled Particles TJJ , Proceedings of the Coni. Brit. Occup. Hyg. Soc. .London, 1970, W. l l , Walton, Ed., Unwin i'.ros., Surrey, England, e 2, p. 683 -69 4.
Langer, A . M . , Ashley, K . , Baden, V , , Berkley, C , , Hammond, E.C., Mnckler, A.D. , .Mug,-?Jo r e , C. J. , Nicholson, V'.J. , Rohl , A.N. , Rubin, I.B. , Sastre, A., and Sel i ko l f, I.J., 1973, Identification of asboslos in human tissues: Jour. Occup. Med., v. 15, (March) in press.
Ehrcnreich, T . , Mackler, A . D . , Langer, A.M. and Selikoff, I.J., 1973, Indentj fientjon and Chovacterizati on of Pulmonary Dust Burden in Pneumoc.oni osis : In Laboratory Diagnosis of. Diseases Caused by Toxic Agents., Applied Seminar on Clinical Pal hoi op,y of Respiratory Diseases, Sundonmnn, F.V,'. , Ed., in press.
Pooley, F.D. (1972) Electron microscope c h n m e t e i xsti cs of inhaled c h r y solite fiber. Brit. Join-, Industrjnl.M e d ,, 29, 1(6-153.
Pooley, 1'.1). , Oldham, p.D. , Cb nng-Lyuu, Urn, it L r.gner, ).C. (1970) The
del eel jon of asbestos in 1jsr.ues, In Pneumocon ios js Proe. of the Coni',, Johannesburg, 1969, ILA. Shapiro, L'd., Capetown, Oxford Univ. P r e s s , I08 -1]6.
Timbrel 1 , V. , Pooley, F.D. , R Wagner, J. r. (1970) Characteristics of res pi r-
able neltor.ro:- fibers in Prenmoron* re is i'rnc. of tho lull. Co nf . Johannesburg ,
1969, H .A , s;n g . i j ' o , E d . , C a p o ! o w n , O x f o r d U n i v , P j e s s , 120- 1 2 3 .
P roblem s and P e r s p e c tiv e s
The shipyard mesotheliorna question epitorai7.es the spectrum of difficulties now posed by the asbestos problem.
Background: Scientists have been sensitised to look for prior asbestos exposure, however brief, whenever mesothelioma is seen and, conversely, to watch for the occurrence of mesothelioma whenever an individual has hd ashes! os exposure. This sensi tization perhaps explains the increasing uneasiness with which recent British publications have been received in this country. Starting in 1968, a scries of papers has appealed reporting numerous mesotheliomas among individuals currently or previously employed in British shi pyr.rds. It is noteworthy that few of those people had been asbestos workers; they had merely been employed in the same yards (as carpenters, electricians, boiler makers , r ig gers, pipefitters, caul h e r s , etc..) in which a rela tively small number of other men (general ly instil at ors or "laggers") had been working with asbestos. Their shipyard em ployment had, in most instances, started thirty or so years before the onset of mesot hi,] ioma.
These British data arc oi interest to us because their ship building and fahiprepairing industry was rejuvinatod about, five years before ours: 193b to our 1939 -1910, ana tbei i mesothelioma experience could presage similar disease in this country.
U.S- shipyard employment 1940-1945: Between the two world wars, approxi mately 75,000 men and women were employed in our shipyards at any one time. The vast expansion of the industry in World War II led to rapid growth of the w o rk fo rc e, wlii ch reached a maximum of 1,750,000 in ihe fall of 19 ,3. .Altogether, 4,500,000 men and women worked in our shi pyards at some time 1910-1945. Given their age distribution in those years, about 3,000,000 are alive. Needless to say, lev.' of these WW II shipyard workers are currently employed in this occupation (which num bers 225,0001. They are working at a hos1 of other trades or professions and many only dimly remember the shipyard interludes in their lives, thirty \earns ago.
Shi py ard ir.esothel ic m a s : As in Britain, mesot heliomas arc now being seen
in this CC V!:t3 3 - in .indivi duals who, in UV 11, vere employed in one or
another Olii
< y jn shipyards -- men and women who bad worked for six
w e e k s , s i X non i h;:", two yeiir?.. Who:.1 1ung !issue is examined, asbestos
f ibcr.s cnd fi bri 3 s i.re readily found (by electron microscopy), in nun
berr conni decani y laiger than 1lie n-1 ati vely scant contamination found
among urban dwellers generally. Apparently, ihe mineral fibers inhaled
30 years ago have remained jntaet, in most instances, at least. The in
d iv id ua l's .xposm (' nay have been six weeks - that of the lung parenchyma
3 0 years..
The ir.osothel iomeo being seen a re boi h pleural and peritoneal, with a propende ance -so Car of the former. An a m i e , there hove b.-on no X-ray changes of eoncomi lani asbostosi s -- it would suoin that asbes tos exposure insuffiei ent to rxvilt in -radiologiealiy evident asbestos Is
Problem s and P e rs p e c tiv e s 2
may still be enough to induce mesothelioma. Cases have been seen in
former shipyard electricians, tinsmiths, engineers, riggers, boiler
makers, carpenters, laborers, etc. Parenthetically, the U.S. Navy
accepts responsibility (in terms of compensation)for cases of m e s o
thelioma among individuals who had worked in its yards in WW 11, pro
vided there has been no subsequent asbestos exposure, deeming itself
the last employer.''
These.1 arc inndom eases and it is not known
how many are occurring, nor what proportion of the 3,000,000 former
shipyard workers will develop mesothelioma. 7" of shipyard insulation
workers die of thi s ciisca^p; if j highly unlikely that those indirectly
exposed will reach this level, although i 1 is conceivable;. Those that
occur will be seen over the next twenty years.
We have1 no way at the moment of predicting which individuals will develop mesothelioma, nor have; we means oi "early" diagnosis (at a time when the tumor is presumably still localized). Therapy has been palliative; cure eludes us.
VillaL is to be done? Many groups are concerned with approaches to this asbestos problem, as to others; labor unions, industry, NIG,311, EPA, DOIi, for e xa mp le , are concerned \vi1h devel opment of engineering controls, administrative standards and clinical surveillance. Scientists at Nil! and elsewhere- can augment and extend these off or is, utilizing, a range of disc ipi;re,, from c pid, -m ioj ogy to cell biology.
1. Can we inseti vat e 1 he fillers n esontly in the lungs of shipyard workers? Can we "deiupc;'' tneir asbestos lung burden before dis ease supervenes? There n>c .our leads in this: r e ga r d.
2. C-'n we develop serological oi other means ol predictive value? Early diagnosis?
3. Develop understandi ng of pathogenot Lc mechanisms, at the inter face between "mineral mat Lei- and the living; world."
4 . Successful tren n.:c-nt of mesotholi o m a ; worth}' task for the National Cancer Plan.
ITegress in these areas will be oi value across ihe whole spectunn of asbestos disease, from occupation;!], groups to envi romacntal exposure, from tie asbestos worker to the urban dweller with, currently, asbestos lung contamination. In add) tier., i ' is likely that biological concepts of fundament al value will be added io scienti t i c u iderstanding.
ASBESTOS FI3R1EC IR DHVjJUAGFS I. GIN
Henry J. Koh'.non and BarLarc A. Flanthol";
n pre
vati- PuIIetln o l.uviroj'inonial Coutaihinatii-: ara Trxic.'?2 V , .I.U73
INTRODUCTION
The purpose of this study is to collect survey data on the presence of asbestos particles in commercially retailed bevtvages. This particular report is restricted to electron microscopic analyses of gin samples from four laanufacturerr-j.
MATERIALS AND METHODS
'
The general procedure of NICHOLSON., et al. (3.972) was followed with modifications as described below. Samples of gin sold under four different labels were purchased as "miniafares" (0.1 pints) from retail outlets in Baltimore County, Maryland. The samples were prepared for analysis by filtering 10 ml of each sample Through Miltiporo. membrane fi iters (AA, pore sice G.Spa, diameter 33 mm) in a Swianey hypodermic apparatus. The protocol for each sampi e warns: .filtration of 10 ml of deionized water through one filacer, followed by filtration of 10 ml of ;;a,male tnrou.gn soother filter, using the same syringe '^.d f.vinney adapt:;'. A13 f:It: t-Tious were dono in a jiUiCK/.- ?j.r hood wilt c. 1cm:a: outflow pressic-e of 0,35 inches lb Cm
A total of 28 contt-ol and unknown samples wore filtered: 14 control sample;;, 9 gin samples-- 3 n.cm Coneany A, 1 ir-on Company B, 3 from Company c, 2 from Company D--and 5 samples of wuxer taken from the water supply of Cc...pn:iy C.
San-ples v;ere prepared for electron micros copy by
allowing the Mi.llipore filters to dry on precleaned microscope
slider: in covered glass Petri dishes. The filters were
subsequent.I.y ashed in tin: sone vessels in av .slung oven at
500 C for 30 lain
os e".rung tin: ase;u rem
were
covered v/ith approxin-a to3y 0 .ff, poimvae solid ion, vhi cb vias
allowed to dry. All operations after ashi.rg v.-erc; cone in the
fit teied-ail* hood. When the Ibrmver ri3.m had dried, it we:
suripoed from the. glass slide by Pirating it onto tne. surface
or H
r-c:-filtered w
ur.dos.ice of the filri, >:id ..ms
moved iron the slice
the
fil1'1 was re m o v e d . 300-rm:sh copper grids (3.05 rr.ui c'ia:;,:to r )
iK'Sc deposited on the upper side o (' the film in arena overlying
the a.fnod residue. Tnc rormv-u- tcchnique describe i here is
*
routinely used in other EM applications where it is desirable to have a low contrast support film for the specimen to be examined.
The grids were, examined in an RCA EMU 3~G electron microscope as follows. Samples of gins, supply water, and control water ("blanks") were assigned code numbers by one investigator. A second investigator was instructed to scan each of three grids from each coded sample at low magnification (2200 X) to ascertain any regions of particle or fiber concentration. Next, the region of greatest particle con ventral ion was to be scanned at 9000 X over b contiguous grid square.-,. (If ,100 jr'-}. Photographs 'acre taken of any fiber observed in this area. If a grid appeared to be wholly negative, then 25 contiguous grid squares (each 55 x 55 g) were scanned to confirm this appearance. The "blind" investigator recorded semi--quantitative findings for each sample during scanning as F, RF, Vi';r, h-- fibers, rare fibers, very rare fibers, negative.
Each micrograph was scored for "asbestos fibrils" accord ing to these predetermined criteria: (a) exposed to 30 minutes' ashing at 5QQU C (true, cf all fibrils); (b) 150~b00 A diameter, and (c) vrhero at least one fibril on the same grid displayed the in, omul "capilLuq" or microtubular morphology described by previous investigators for chrvsotile asbestos (LANGEE, et al., 3911; FOULLY, 1972). Each micrograph displaying material which did .of meor ala of the. above criteria war recorded as "non-aobestor (ooiif-j.iiu.-ition. "
As estimated maximum nlumber of fibre is in each whole 1C-ml seepie Wt.s calce] area by mull.iplying The number of fi.Lrj.le observed in m grid squares by the factor (10.9 x 103). This factor is based on ino assumption ot a her:,ogencous di,stributiori of fibrils thi'-oiiphouU 11c cample, and it is dore'ved fro..i the areas of T grid squares, of the total grid, and of the total Mii3.1.1pore filter, as indicated in fable I.
TABLE J Calculation oi Factor fo:a Est5mate d Total li:tirer of Par-tides per
(A) open eroa of b gri d StjuciXes , 300 mesi) = 55 x b5 " 12 ,100 ;j2
(B) oinmete.r of grid - 3.05 nan ~ 3,C50 ju
(C) area or grid - D X 1575 x 15 25 - 7,30 2 ,'i62 .6 n 2
0 0 *e i\L'>) - 60 2.51 (E ) i.r'r ni* raid - pi x 1.525 x J .525 ~ 7. 32
2
(E) are7-; or i.i115 pore f liter ~ pi x 6.5 x 6.5 = .1.32.67
(to <r)/00 - 18.12
(H) (P) x ((,) = 10 ,936 : conversi on factor' i0 3 x IQ3
RESULTS
The data obtained from each of the 28 samples tested, including blanks, is compiled in Table II. All gin samples from Companies A, B, and D were completely free of asbestos contam ination. Asbestos was found in two of the 14 control samples; in both cases, the samples following those controls were negative. It should be noted that each odd-numbered sample is a control for- lhr. sample rui.iber imre-Ji arely voliowing it only. That is, the same syringe and V- inney ;dap,,or apparatus used for each even-numbered sample is first wesir-d with distilled water'1; the filter through which this water is filtered is assigned the preceding odd number . Such "bl-'o'i t u s u a l ! \ not included in published reports, are; given here for the sake of completeness.
One of five water supply samples was positive for asbestos. The three samples of gin from Company C had significantly more asbestos fibrils than the sar.pl from any other source.
Examples of the fibrillar morphology observed are illus trated 5n Figs. 1-3. Fibrils ver- ub./'st al./ay;. individual or in very tri-lj groups; ibis j m o s t likely because of the instahilify of mact-'ofih.;rs of cbrysoiiJv ashes in solutions of Itr.n Lban pf IC.f (FA.' 1 a..d rA'FF,, l'Jt-5). Tne dissojutj.ru of native cimyoolile info v.u' f5Fw.F j.s war; not F `rroar-.-god by our tcchuicui, L-weaer, ui;.r. y c inil '"C. .-1 iibril.; ail aw b'~tt.w resolution of their ioc.rn.J wax rboj ogy, and Thus allow for :ore posit'vo ir.usti f i itici oi a-real.-v in - 1nr ir-m micrcgj'cr.r.::..
DlbClSSKb'i
p Inevcaving eviclt wcp of envirorme>d al rsb^ctos coni amo n a tica from athor than ai ilo?re s o u r c e u , or ai fc cvi.eg ergono oiho-r than th l u n g , is curronty gfinng e iterition as e possiblc ha sordi to health (il ,11! S and Ldbkf",;. , iCCb; >Filili.C-ilAM arri ?0;TEFF ACT , 1271; liERUCC, 1271 ; NICiIOLLOF , et ai.., 1277; cfirKOlT. ut el. , 12bd; Sii.! KCFF, e.l rii., 1272). hence th. < ir a r.eed far i.Trdcpeucer.t inveri Igr cor,:: to fino out uh ere suoli ror.tw.T.inat 'c, : rerJdoc, end at th sarne timo to de/elop a lelitibe surv-jy ij^.tn-o 1 to monito?' commerci el s u O p t a u r e e . Tbi s r^f.bo'l cannot m, so oahaiv:- uivo rs to i'icp'iv ' 0 tir laser a'wii'w > l iiwn ol a tv si e i; a o m l usi w i (e.g . !br to 1 7 7 ar nr-esLoa >./, FlbdOI S P I , w a.'., 1272), bui ori ho uther b a n d , le must jlcld di stnge lri:L io -'wrltu which ore c b v w l y indie at ivo of asbesto:-; cori ras :nctior . Li th p r e d i c a i s]>ho c , tu adequate r-uvvey m d h e d night Le ar.od hy riamano ibi e gover-jn.-nt cgencier to eleo 1 ine rerpe.irib re coi.-a.mic-.s to imni-tabe moro iriorou,-h jt-eunarch i.nto tb.ir oupr-d of t,m-;r quality con tro! procedure::. Lue mefuo-d dscribed in thir w -w ; , unici ir
basically an application of those employed by previous investi gators, adequately fulfills these two prerequisites. By using a blank control for each sample, unexplained contaiainaLion as found in ii21 invalidates one sample only.
In the present instance, the type of asbestos observed is almost certainly chrysotile. The length distribution for ehrysotilr as determined for U.I.C.C. Standard Reference Asbesto Samples shows 3.8% of the fibrils observed ro be Jens; than 2 microns in length (KANBAnL, 1972). In addiiion, the internal capillary substructure referred to earlier is considered to be very good evidence of the presence of chrysolite (flCtiOLSON, c! 1972}.'
Since the method of scanning is biased toward the finding of fibrils, the projected nu.fibers of 'fibrils for each 3.0 ml sample represent a probable r.aximu. Thus Semple ilo , for example, could be said "to contain not more char: 23,980 fibrils per cubic centimeter." Therefore the method used in this in vestigation is recommended for doterironirg whether asbestos has hcna added to liquids during the course of their- manufnclure.
lib i: i i rOBLCLG
B in L S , B . , and LLERSCR, T .R . : ita t u r e 2 1 9 , S3 0 9 1 1 ) ,
CONNI 11 Gl] } ,`3 H .K. ,. and PC in EFRACT 0 . : La tu l a n c e '> r *i"i* 5 SELIK0FF > i *J . , and S A ST R O, ii
aHealt h 2 2 , 348 .971).
BERI.ISS, f.R. : Sciene 2 173, 1141 (13 71 ). N A G Y , B. and y. a Ht.l;s, T .F ,, ; Ai:icr. K Lnnxvii n
NIC! 1 0 I,SOR , O.J ' 5 MAGGI 0 0 - '5 C.J. , and SEBI l.5
!-_t-4
177 ,
(131 y ).
BOOLE Y, F ,D. : B, It, in dust. Med. if 1 hi
iff:LA LL, of U .j . C. C . K .R .l ,0.D
a ;r-tu C(he ets ot p r.trj ;(vl SL a n d are Ka.f e? c r . c e A h ,, o ;-t ) i) b ', j ts
1972.
t <*u ;>0 t*'*' s r.!V 7 <T
S E L I K 0 i ' i \ i . j . HAi'Hh-J.N L), V, . C . , ami CL iJi"_.d;h'> 5 J Aarm. 2 A ); 10 d (1 96 9) .
SC i d K01 F , i . J . , 1! hi il
at tu e Int< .rea L i o n e ]
O ct.
i t
*j`r 7 y ^
rO , F. C. Ar;c iiC y f o r
CL j DL Ar L a >lbO r e i \ r,r;
Orig. Mo.
TABLE li
FIBRILS, Code Semi- numbers of No. quant. asbestos.
PRINTS, numbers,t non-asb. Sample
Projected fibrils (x 103) per' 10 ml.
1 WS WS
2 24 N 0
3
8M
0
*4
9 RF
0
5
1 RF
2
b 15 H 0
7 WS MS
8
5h
0
9
4 RF
0
10
11 F
12
11 W3 IitTO
12
25 F
12
13
13 RF
0
14
23 F
22
15 14 N 0
16 19 K 0
17
2N
0
18 18 N 0
in 16 VPl" 0
Of'.
17
vi'.r
3
21 22
wr\
/*t 21 N
0
23
7N
0
24 10 M 0
25
2 pr
0
26
3N
0
27
6 RF
8
28 12 M 0
contr.
0 gin A
0 conti'.
2 gin A
0 contr.
0 gin A
21.3
contr.
0 gin B
1 contr.
1 gin C 130.0
contr.
3 gin C .130.8
4 conti'.
0 gin C 239.0
0 contr.
0 gin D
0 contr.
0 gin D
j contr.
0
iiata C
32.7
0 contr.
0 water C
0 contr.
0 water C
3 contr.
0 water C
0 contr.
07.2
0 Viator C
Original numb ar indica ter; other of fil frati on and asb ing : code number indicata 3 order of ana lysLs in Fi". "MS" - "won't strip," i .e ., Formvar film could not be si ripped fl'CIii sii do after ashin g . Other
abbrevi?rions given in 'C/'it"*
N/ //
l 'y"
\u
,
/I '/
/)
/ A/ ' &
/
y
ct.'"~h3 r
f
ri n
tyt l 1 ;
i< lJ
No. yo u
/ \ f . ..- -j
'. '> f ' - ~
i[ i
V ,'
Perm-J
a
l r-.v^ j> X i L-gL:
r-m r\ l- \
[ ei r`s.
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LIOIHD CLARirYiHG POLISHING \/
Cel)u1oPCry.stel W'niio "acid-woshc-J" asbasios-colioiosc filter pads, discs rnd '.mets offer you the I'lrmafc in c o n tml t e d liquid filtration ...run aftei run. Crystal Write filter pads are inert and chemically pure, ll.e ir-ige dimpled surface area, combined with its uniform depth for adduionai contaminant storage, assures economic;)! iilio bon cycles.
f.C ! i:C Ci.i
RA-FiL'c HNiSHING "X STF.RiLIZATiOf!
Idea! for Ultra-Fine Polishing arid Cienlization
Crystal While til' -J p'-dc c e paitmulany leccmiyu-nded for rub micion liquid idtnuion invoicing ulim-hu:1.nolmi. and brilliance, and cold aim Hi/-lion of bmucs, oharmaccuticuit, beverages, syrups, etc.
Cellule offers fifieen s* jr.doidizrd grades of OrveM White "a' id-
washed" asbestos c< ilulosc filter pads cicvelop.-ri f'rspecific de
grees of conmm.uant retention arc! flow into cep vrli'ic-s. Paler +o
chart on rcveiuc sole for actual relative filtration chr.iocferistics
of tna Crystal Wivte grades.
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All pliascs of imcriec luring ere Uife eordinuoir. CjUaldy corbie! Ccudant leivoriory test:, are irmdi. un uiieinical ole.inline:,. and ina,tnerc powuiy, p.i .bns.ty n n thrmricion d stabMity. No lim'ieb" euiry ni i-.,:.i.aoiy e q n . v nas been rpared to give y.'>n(he til.'d VO" r ' 5(-1
F.iectiolicall, C jnltoll'.cl Piodu m n me Pio.c'dm, built-in Unhcrnii'.y, Pad /-.iie .d
i'u-yi: IblT'liK , l ( : u:'6 yCh'-.r'y ,i 'cut Cry-iel Wtnlc idler pads, th avniinh!;.' ;ip vi 36" -- in any i.ea and snap nnv hlh-
iAi i i! r a i l a g e s o f " A e i d - W s h e d H A s b e s t o s
r. . , v r .t O f t tV. c j \ I i tU v >
D F' r ' J - B l C T A U L L F L O W R A I L ' S A K Q m m SI r i l F i R i u l ; . . .
A l i k RUN A g iv e n g ra d e o f
C R Y S IA l W H IT I. filte r pad is u n ifo rm fro m s h ip m e n t io s h ip m e n t Y ou a ie a ssu re d rig id filtra tio n q u a lity
co n tro l and eco nom ica l filte r cycles.
n C O M M ER C IA LLY FREE OF ii,PU R ITIES a h c d iu io filte r pa ds are co m m e rcia H v-fre e o f loachable tra ce s o f co p p e r, c a lc iu m and iro n n o rm a lly fo u n d in c o n v e n tio n a l u n tre a te d pads. T h e a sb e sto s fib e rs used in C rysta l W h ite pads are " acid -w a sh e d " and tre ated by our exclusive C eilu-W 'ish process u n d e r rigid q u a lity control.
WIDEST S E L E C T I O N O F G R A D U A T E D G R A D E S A V A I L A B L E C r y s t a l w t v t e f i t t e r p a d s a r e a v a i l a b l e i n a
co m p le te ra nge o f g ra d u a te d g ra d e s ( 1 5 G ra des fro m N o. 3 0 io N o. 1 0 0 ) set to p re d ic ta b le sta n d a rd s . G ive you the a b iin y to m ake a p in p o in t selection o f t/io C r>stal W hite pad fo r o p tim u m flo w rate.
n PP E C S ELY AND CLEANLY DIE-CUT TO EXACT n ii.T f.'SiPN S C ellule C rystal W hite pads are die cu t to e x a c t d 'm c n '.'n o s , w ith all h o le s a n d e d g e s s h a rp a n d clc m . . . e lim in a te s tra y fib e rs a n d p ro d u c t c o n ta m i n a tio n . (J n b o rm fiiiin g o f C rysta l W h ite pads a s s u re s m in im u m la b o r cos! in d re s s in g y o u r filte r,
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n PRO B U LL SOI.Y iN ii Are you e xp erien cing a d iffic u lt n itra tio n problem ? C ellulo offers com plete field s e i v i c e a n d b b o r j i o r y p r o d u c t t e s t i n g t o h e lp y o u s o l wo { h o s e p r o b l e m s .
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Easy-io-coni? o! Carhac Process offers a prac tical, low cost method of maintaining rigid product standardization- purity, clarity, color, aroma and flavor. Equipment is uncompli cated. Procedures are simple arid controls
are positive. Can be operated at ambient tem perature.
SLVEN-UP BOTTLING CO., SAN JUAN, PUERTO RICO
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Dr. IK'-..;: Pago 3 March 15, 1573
If you xecruiro eocHtionc-l information plo no contact
rio ~t, rosy ti'.i-i.
Very truly vor?,';*;
rarxer,
Prosiec-nt
Hihi:r e
b e e : M r . Ca >s1 1i...`,aan b e e : Civ O'ulo le ; Hu'S
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THE USE OF NUClEEGC^ FILTERS IN LIGHT AND ELECTRON MICROSCOPY OF AEROSOLS
idvc-lyn E. F E A N tC , K .E . b i 'J P A 'i ' *, C.C. K K L I C L L V and Jantt..-. P. LOP Go Paboratory of AUitu^,jrit,ic ,,'n p -.Vufua.aZ C a n i t r :or At.-.-^iph
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p ri'tr.'w d lig h t a t.cm sca ry.
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DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
r PUBLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATIO N WASHINGTON, D.C. 20204
July 12, 1972
Barry 0. Casfcleman, M.D. 305 West Biddle Street Baltimore, Maryland 21201
_
Dear Dr. Castleman:
For the post year the Food and Drug Administration has been exploring methods for identifying asbestos fibers in foods and drugs. During this time a number of products have been analyzed for this contaminant. As an incidental result of this activity we believe the use of asbestos filters is being discontinued.
In spice of the best efforts of Pr. Longer, experts from the national Inotl tutc c Occupational Safety end Health end others, there are preblcims which have not been solved.
Briefly, the. problem is that methods which identify asbestos do not really shed any light on the number of fibers present. Methods of counting fibers, either optical or electron microscopy, do not definitively identify them as asbestos and do not give any idea as to the actual number present in U/U percentage. .Since asbestos is present in the air in most large cities, it would be impractical to set a zero tolerance for fibers without introducing changes in the irauufacturing environment and in our laboratories which are quite impossible at this time.
We are currently using all available methods for asbestos analysis but
it iu a ale.;; process and we are still unable to correlate weight of asbestos
end fiber content. Finally, no current method o f analysis is accurate
bedew 1%. Thus, we would not be able to enforce a tolerance below
this level,
.
bincoredy y o u \ .
/ A.,. t'JtV .
/ ' (.V-fi-df J
, ''I" I ll H t r t + ..J k X J i h u K , GovdyJ' I-i.Q , r~ leni t a u t Director far/Medical Review D i v i s i o n o f Colors & C o s m e tic s Technology Office o f Product Technology
1
DEPARTMENT OF HEALTH, LDUCATiOM, AND WELFARE
P U uU C HEALTH SERVICE FOOD AND DRUG ADM INISTRATIO N
RO CK V ILLE. M ARYLAND 20052
OCT 161972
Honorable Charles McC. Mathias , Jr United States Senate
Washington, D.C 20510
'. ,. `
'
.
-
Dear Senator Mathias;
This is in further reply to year August IS request for 'COmLunt on .
a letter from Hr* Barry Castlcs&a, Baltimore, I"dryland, petitioning
the Food and Drug Administration (FDA) to analyse beverages, etc.
for asbestos fibers used in filters i n food and drug processing
plants.
The Food and Drug Administration has each &n investigation in progress. If these investigations rc.ve.cl the presence of hazardous materials in food as a result of the use of asbestos filters or any other food contact materiel ell accessary measures provided for in the lay vill be undertaken to protect ' the public's health.
Our agency hat* been nvarc of the electron microse'/po methods rsed at the Mount Sinai Envirc-aruintsl Sciences labori^ory, to vhleh Hr* Ccntleman made reference., He hove collaborated v l t h . thetj i n ' eruilining samples of talc. The Food u; 1 Drug Adainistratimt has an on-going contract vith this group at the present time*
la further* coping vlth the problem of elimlimtiag achestos-fora particles from our food supply, FDA published a proposed regulation
in the August 3.2, 1972 Federal register which states in part that
"any food or food packaging material containing talc that is not free of asbestos-*fora particles shall be deemed to be adulterated in violation of Section 40.2(a)(1) of tha Act," (lederal Feed, Drug, and Cosmetic Act),.
If ve can bs of further noclstance, please let us Uucv.
Sincerely years.
2 iF`closures
C o n sti tu e n t' s I t r
Rcpr FR 8/12/72
G e ra ld * Ho, o r , D ire t i e r
Office of X/.-giulativo Sowices
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INTER-OFFICE C O R R E S P O N D E N C E
rpQ Thona_s_H. _Devli_n _ _
Date__ Senjt_cnbp_r__2_,_\CJJ?________
F R O M Barry Castlemnn and Valjean Ganbill
SUB JECT Ji?13.'N I P_3__FILT_r>)S_TN._R'JK-'A0 ppCC >51NG FUEL]MINAI Y REPORT
IN]'?<O D U C T I O N We are performing a survey to see where asbestos filters aie usecJ in
processing beverages (soda, beer and whiskey). Where such filters aie identifiable, we want to tissure that appropriate worker protection is in force and ascertain whether the fibers are showing up in the finished product. To determine the latter, tiie electron microscope laboratory at Rosewood State Hospital offered to perfore electron microscope analyses on samp]es of incoming water and plant products.
Our reason for concern is that ashes: os has been identifie) by numerous studies as a potent canccr-causing agent. In a mortality study of insula tion workers, Selikoff et a l . (Mt. Sinai School of Medicine, New York City) found 41 cases of gastrointestinal cancer where only 12 would 'be "expected" based on U.S. Mortality figures. A similar excess has been found in a study of insulation workers in Belfast.
The Food, Drug and Cosmetic Act states, "Thai no (food) additive shrill be deemed safe if it is found to induce cancer when ingested by nan or aniralP Cn August 1, 1972, the Food and Drug Administration proposed to ban all talcs for use. in food processing ah', eh contain asbesi ii orr. mineral fibers.
We aie alarmed by the careless use of asbestos in thousands of pro ducts, many of which give rise to hazards 1o an unsuspecting public,. In xln. case of beverage processing, the unique properties of asbestos - heat, acid, and aIk.' 1j resistance - aie not 'called foi, and substitutes can seedily be found,
F -d vP l M T H -V Y K . P P r:P N
hone o' ihe several sod.', ma.nui act u rerr. r-eri an ted wc;e found i. i a shew le..- car >ai ,i'u. ' i i t ' 5 S .
The Carling
wer y was found to use
the polishing (final) filter in beer processing.
called DIA5BLST0S il'i
The Calvert Distillery was found to use filter mats from the Seitz
.r
*
Asbestos Works in West Germany on all products. However, in aaost cases this was
followed by a cotton filter and a final charcoal filter.
Grefco, Inc. (in Los Angeles), which manufactures DIASBESTOS, did
not respond to our request for a breakdown on the composition of this material.
S'.VK Machines, U. S. distributor for Seitz, informed us that the
filters used by Calvert are 2/3 cotton and 1/3 asbestos.
Preliminay analyses of samples were performed by Dr. Henry Wehman
using standard electron microscope techniques (0.8 micron millipore filtration,
high temperature ashing, low power scanning, examination of representative fields
with E . M . ).
'
"
Numbered samples of Carling beer taken before and after the polishing
filter were examinee, the examiner did not know anything about the samples. The
post-filter sample had asbestos fibers present, the pre-filter sample did not.
A sample of Calvert gin drawn from a miniature contained asbestos
fibers. As a control, samples of metropolitan water (from which the gin is made)
were analyzed and found free of asbestos.
These preliminary results were made known to the companies on
September 21, 3972, by which time Carling had replaced DIASBEuTOS with a cotton
type of filter: medium. Ca.lvert was advised to seek a non-asbest os replacement
for the Seitz filters.
.TU:
A number of samples of water, beer and Calvert products were ps
pared for electron micro-cope analysis in a larger study which will have built-in
tests for consistency of iccnniquc. Several other beers brev/ed in tbs area will also b e an a 3y acd. The results should be: available in November, 1972.
-
1. Selikoff, I. J.. E.C. Hammond, li. iulnau, "Cancer Risk of
Insulation Workers in the United Stales", presented at the meeting of 1he 'Working
Group to Assess Biological Effects of Asbestos, International Agency for Research
on Cancer, Lyon, Fiance, October 4, 1972. 2. Elmes, P.C., and M.J.C. Simpson, "Insulation Workers in Belfast
3. Mortality 1 9 4 0 - 1 9 6 6 " , Brit. J. Inaustr. M e d . , 28, 226, {1971) .
_-
3. Federal Food, Drub and Cosmetic Act, Sect. 409 (348), (c)`(3)
(A).
'
4. "Proposal Regarding Regulation of Prior-Sanctioned Food Ingredi
ents", Federal Regi s t e r , August 1, 1972.
'
rAsT*Af:f, M?'. CNAtnMAN
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C H A fU > s M C C . M A T H I* 1?, JF ?,, M D ,
LiJV .'A R D J , G U H N D Y , P L A .
JO H N , i. SOLI O M A N if CH IEF CCUNS L i. ANO ST A FF DIRECTOR
COM .IHTi>: Oli THEJUDICIARY WV.i!HINGTOr-;, D.C- 20510
December 11, 1972
Mr. Barry D. Castieman 305 West Biddle Street Baltimore, Maryland 21201
Dear Mr. Castleman:
Thank you very much for writing me again on the problem of asbestos filters used in processing foods and drugs. Your diligence in pursuing this matter is greatly appreciated, as is your offer to discuss the problem further with me and my staff
With best wishes
Sincerely
CM :jTiwc
Charles McC. Mathias, Jr United States Senator
DE.PAR7M! .'T O}- HEAL'D!. "AnAAAA ! j'! AAD W 't'.lFARP PUBLIC IifAt TH ' r U V i r r
FOOD AND DiU'D /u5M ,N1bIAA'IION
V M S H IN .'.IO N , D C ?0.'U4
' January 2, 1973
Mr. Barrv I. CasPieman 305 Vest Biddle Street Baltimore, Maryland 21201
Dear Mr. Castleman:
This is in reply to your letter of October 24, 1972 requesting information on investigations of asbestos filters.
The Food and Drug Administration has requested several firms from the edible oil industry and the beverage industry (both non-alcoholic and alcoholic) and a representative of the asbestos manufacturing firms to attend a meeting January 4, 1973 to discuss the problem of asbestos, including the technological aspects of the use of any types or forms of asbestos in food processing applications.
If such materials are being used, we have requested that they furnish details of their use including data as to the amount of asbestos fil-err present, in their products and steps taken to assure- the absence of asfce tgs in the final consumer1 product . They should also consider when: they could use as a replacement in case it became necessary to eliminate all forms of asbestos from food and beverage processing industries.
Methodology is also being studied by Dr. Lewin, of hew York University who is under1 contract with FDA, and Dr. Selikofi, of Mt. Sinai Hospital While Dr. Selikoff is not under contract there has been considerable 1 contact with him. The most promising methodology appears to be X-ray . Diffraction plus Optical Microscopy. However, many problems remain on applying this methodology to the regulations of asbestos. Types of asbestos, how to report the fibers and levels of detection are some of tne things to be considered plus c o j loborat5cn of methodology.
Enel os"ore: cy Itr sent io
Senator t`a1.hia
Sincerely yours ,
O ' on
Pat T. Aaamo
Assistant to th Director
Division of RogulcLcry Guidance
Office of fornpllance
Bureau of Foods
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January 17, 1973
Mr. Barry D. Castinman 305 West Biddle Street Baltimore, Maryland 21201
Dear M r . Ca s11eman:
. 1' was dismayed to learn.that t h e r e s p o n se you ieccived from t h e Fooo and Drug Administration concerning asbestos 1liters a r r i v e d too late for you to attend t h e Administration's p l a n n e d meeting.
7"
X have
ta k e n
th e
liberty of c o n t a c t i n g
officials
at the FooJ arid Drug Administration once again on your
bchal to e P Tess your viems; as s o o n a s 1 ' i o c c J y o t h e i r
reply, f wi 1 be back in t o n e ' s vith you.
V.rith b(.-st v;ishes
Sincerely,
C M :mKc
DEPART,OPKNT Or !il-:Al li !I fliV.-CATION, oND WELFARK
p u i -;l !C. H f . / . i v > . i e r v c i : FOOD A l l O DRUG Ai iM : NST RATION
R O C K V I L L t , M M { Y L / i N O ZOV.S,
r . FEB 2 6 1973
Ilotorablc Charles McC, Mathias* Jr.
Unito:! h i ' . t c o Saint-; UrUiayton 2). (j, 2 0 5 1 0
D o n i' A v a n z a r M ritbf.us:
T his vc-plicu to your r(v.;ttc3t o Jormrty 17* 15??., ;rldroaec>tl feo " Viral?. 0 k Lrodcl^ o f cur Uwrcfi.u o f ro^dcs, fo r euroa-mt cn a
Jotter fresi Mr, Barry Cattleman* i'nli:ftz.-::z'&$ Mstylno"-* era tfc.3 use
o f c*b?r.tos f i l t e r s i n th a fo o d in d u s t r y .
Via U ovo n o t c o a ixU e d ar.y li& irjr .g cucii r.s reijwcDfctHl by M r , C s s tle s u m o f the typos o f asbestos filte .r o v M c h n ry bo used in the food in d u s try .
A&bC'pi.T.n it. causi in Many focate of f:ho food r.'-d beverage Irdustry os
filCiiti'-.::ftiUo, Irfitoof: ilood industries* poli.?!* or filial filter? eve
v . o - ' l ; , .`..vt-v- tie- near ctoii bi? v v v , 7 .esc ere* irti v y of rcyon nn:l paper*
rilr
''Itero* o r i
eve-
-tor,,
Iri n -try lire cbm yed w, i m i t i e r Love I x t i K t -'to nveiX i r a on r t ?
m v v r o b -Jv.' o
.ms.av.rc cm eng y, ,v . `.e;; c l: \ c m m t r j m m e m
c:,v us..';.
cfcvdxm {.v v m m 'm ..y b m ; p,mrv.!m; rmm,U e t bey ima
f x l i v n i-r.iff.irvv to e a r n cr-i eecu s th e n to c v & io :: vmm fco u.;t:y tu e boor*
th e s m la e c ? logy i s max?!. ;m ?- '.vilixcuv.c adneuepm y,.
The Biuoy l>y tiro CcrtidCnr* ic e d {ivi Brag Y/Xztiitc v a f o u c i 3 n ic e trot n.ierem m yy bee i r o n te i,cd ly m im m i. m c c m c h c iy i t th e Im lm d i-tatea* b u t th e y ben;, m i B rea cbm, ro cm;v i r e t e th e in n lr m Ibem o f th e e x p e rt: o f a c tir n 'clogy fen? t i n t CiCecro.u rie ro v c o p y io i.ov r e l i a b l e read i s \o v y d i f f i c u l t to m a oc c c:viif: c ?. t e e i .
Ac Ii n C m pim m u navi rypr>.m r.f'C* i t ma-imo. bo r ; cV.ge. to ? c y y fs m Pio
lo v e ly o f o fx'l'i.'-or.m. u i o t i id edm m fm r.e.ii.pdam py io j-J t fcW.iLr.blu to datom i'..- ; .;,y v i o l t t f o . r ' tbiot t r y e c c i;r ,
X''!*. v " ;-v c e c o pi'.' : c-vi
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r t i ' V i s i :-. v a y io , L m v :; , i.u iv 'o ic a t \,v<> i hot vet, ie n n clr.r.o a>
c o lia
ko <-c.*> c o t a i m m r - C iic ia l (colL-l-i .-;!te a ) : ;3shod e t
rk m t i - - '-, b e ri; fri fm c c v y m beri vj?. fc. an u3 i \ z. zivjI u l . ho > id r;?;.
d a tn !v'va boon a l-m ir e d 1 / o m iy c tv t ^ i h i r r j on x?yi` i fc o c a .
5Y'[:,r.' 7. " 1iGTiOj.i!ri)o Charles McC. Math lets, Jr.
Via wmld appreciate any help va can get in obtaining workable methodology. Perhaps Mr. Caotlemnn w e l d earn to volunteer data he may have available on methodology techniques. Kr. CuGtlc::m may be asstuod that work is eontiinii'.tg in trying to perfect: reliable methodology.
If we can be of further assistance, please let. us know.
Sir.acroly your -,
'{?>r* 7 .'}i_<*' *--v
Con?titvarit1s It:r
Gerald F, Meyer s DJ.rector Office of Logielo tivc Services
T>in! L ' M O K C C O U N T
in irk-OFFtcr.: c o s i l l l :.<\'o:-r'C!.
Uill;;" !.. Phillips TO_________________________ _____________
Toccai e r i Gnrvces acct.Ion
FROM- ____ _________ ____________ _____
S F B I F C T Tsbc-etoc- l v . r S t u d y
Januars 23 1973 Date________ 1__________
h a v e I v e ; u p e ? . o u c i i s F r . T i c k V e n , L o r o f f r r , i rie o i t -o i x t m t
c e . c a v i a " ; Lr.t. ; .'ivd.-r; u a d i n t i h c r i F k i u f , o f b e a i . . L e , V i r i e i e ; c b e u l i o ].:;! a-::`t i.i i M i i u n r o r o t e r - t e 1 3 t e a r e d i , ; t o t h e b e e r : n u e f n e t ur. e r . _n
abe
o j . e n o M \;r.5 c a l i i n f t o i x n i r e v h a t r*: v o l a t i o v o a p p l i e d .
Y o a v.L! 1 t e v e v e e r fJ,M: I v o a i e u e . e b a-u i n v e r t :v;tio.i v i t e Y a X j e a a f - ,'v:'' c " v e a d fe r i i v o i v i v f i c a l e a f " o p t e r b e r an-S v a fouit;? . - n h e i P . ' o ^ - o . o v f ininf-, f i l t e r : . , ;.v t r e n z F a M i v : F e o v a r y , e l i b L a - . x r t D i M l i i e t y , e n t i p r o l i -va-: ; y > v < v r v - n e r . a n e - ' - i e e i ' n l v a e r - I v n i x c a s n F t.v i t a l u m n t ci' t h e f i l a n o i n t i t o l i r a i p r o d a : : ' - .',
; V Y b b r r i r f o r r a d re* t a r i fet-.r ; r o v o r i o a v e t o u n i r e ; G r e f c o C
D 7 .1'":. ; i ,;b,: .-e tb.' t i a.- o f o a t s t u d y ,
b i n a i ' t h m a l l f o u r lima:: v o r k o d o n
c u i t x V a L a . x a i -M
t:r ti t u f e r L i c h I n o l e a w i t b y C r e f e a , c u d v i i i c b
j a;
: ; b - v *- ; I ! corn:-";/ ;b tn.r.a-. o f p '. w f v e i ' o v a l i t y .
In fact, cur GovM;v
- ."--..l
: r- ' J . l f a
Ike M i r e a a n ; b r a v e r a to a a v e r t lx : no
; '-'''.a ; - '
b i . . t a f - l a " L e v t o - a r c a n i ; a w " - e n t a i " r e . M a L i a n ;i
'a n o Mi _ 1 e ,a i t - .'rop, n 1 bit. "'1C 1 '-te aCh M Mi,l-1CCy CC/; CC i.s'K' t111
\ .c
:.0 L ab tilt; La vi M l v a i ; * r.n *avi in.Lion. )n rcaponaa t pin
., . !1 -ni tve M a;- -1
Ira--ilvod ver e r::r; cicute-' u tv.. Dedarai
T --: : x d o; - ,.vie -it. i pa--- a ibi Li ay ,.b :J.t i o t i of il) poi fiancee or del.:, fui: lotut
es-...,, -ai O r.abat tf e ; vhl'b'r can ran reeCn.O , Lo i r e i -:. La aprati tuet it
rraient x t fa a:a c`abevtoo recae v, afe ;.'Nit j-i. Oli u ere rea.Illy available.
harry Carole-w I/o
f, :
ENVtRONr/iENT A L
DEFENSE FUND
1712 N STREET, N.W., WASHINGTON, D.C, 20036/202 833-1485
December 14, 1972
D. Henry Simmons, Director Bureau of Drugs Park Lawn Building 5600 Fishers Lane
Dockvi11c , Maryland
Dear Dr. Simmons:
'
I am sure you are aware that asbestos fibers have been reported to be present in some parenteral drug preparations (Nicholson a t a l , Science 177 (1972) 171).
Vie would like to know w h e t h e r in response to this report, the cempanj en concerned have modified their production methods in such o Wc.y as to exclude this carcinogen from all infection fluids. Tf by chance they have not, will IDA take action to asc u m that they do?
We would appreciate it if you would provide us with the answers to these questions, or advise us where, they can be obtained.
Sincerely,
L A :ro.h
r>.
Lucilc Adoiiikon, Ph.D. Staff Scientist.
i:'\
C . ,-/*/
Scott Lang Wrish in o ton Cc un se 1
/
O H .1 i ' f TfU S-.V JK. i, NY u M l'J Cl V r " N L `. iOFih V IIY
"'rO H i ('"Mtt|, V.'ASHiNG'tON', HC, Btf.hHc: r, C <f.
r N s p u p '"r i .(i c y c - o to p h / t c i f i';,, cr'\ Iro'tni eot
p
H e n r y Dii m o n e , Director 'rn.'`;;~v >i i\.
Pari inv.'n Frail/tln
5r-C,r)
r; Lane
iodlV 11 C:e Coty] rOK
Kttention: H r n . Po,Inarovo.
D o n r Di*. li iron a :
C i P ocer-bor 34, i ^ l t vn noni you n lottcr inquinine!vHrrlor Hot i.s t r i o n -- r.clior: i:o inauro !'>. e x h r i o n o f
Co;. i rem prrc.r-Cornl dnv.'j, cove oo ; chici in ou-
coi,iid. t.o oT line ente * 4 :otrrin lo or - v;o Uovo recoi re e no r...: .i.c-.
V]io prooonoe of nobocioo in an'rc v m edl'-c lo t he
t-';! V.iorn-o^"
n.premi) li 3y ? veoivr; o.q o , or poro -
l.orr'orr noliem l-y llo en c m e
" 1 n loop o v e t i o .
il>o c,V':ci.S OiiG cor:to ?poh in oro cernirai lui' <*- cit
noi r-' oft ielle curi o'jity ,, Ve v.'onir rmi!'/ li io
l;r>f / t K - ' rea, morr r e t r a m
H o v.c-l i o v o Lhnt: ir-: h :-vn b o e n
fine :'ic i;nl}y p o t i m i in vnJ nne ?or c roqjy, loiooo ir'
r c r o r o yr-ypon&e io ino y m otri tted io iter
oro
rno' i'ro'0 Uii-y, 00 vili
n'cv CPc int a r i n o no
ari :'cn c-onoern.i *9 l'v pro'lfc"' r'oni-lon'-p f r.,n vr_ >0.'! 1 "<" .
CCOlllpl y ,
Folnceroly ;
L e v i l o !-'. / C m n o n , P h J> Stari rciirv-iot
f'or-tt H, L o r o T-'- 1 !,;;Leo C o
t
/; ' l> WEI FARE
fanne ur/,i ,, ;'r ,
f o o d a f ;.> d .-j u c : v n ; u r n '. ' n o w w a s h lucci o r , : ; c 2 u.v.
March 2, 1973
Dr. Lucile Adamson, Staff Scientist Mr. Scott Lang, Washington Counsel Environmental Defense Fund 1712 K Street, N.N. Washington, D.C. 20026
Dear Dr. Adamson and Mr. Lang:
I regret the long delay in replying to your letter about asbestos in talc.. Part of the delay was due. to a heavy load of other responsibil ities, and part was due to a hope that events might have proceeded to the point of resolution of the various questions involved. Even though this hope has not yet bean realized, the lapse of time has been great enough to impel ne to write as follows in response to your specific ques tions ,
Your re mirks on the health hazards of asbestos are of course wellfounded; this his be mi of concern to us for some time. In August 1971 I organized a discussion session at FDA on asbestos: in talc, which was attend,.d by almost fifty representatives of industry, universities, and govern.':,' ah. A major topic at the mee.'jug was the analytical methodology for dotnoting smell amounts of asbestos in talc. This was recognized as a difj-j.c j lb problem which is best: attacked by a battery of four methods (optical microscopy. X-ray7 diffraction, electron microscopy, and electron diffraefion) and possibly a fifth method, elemental analysis by electron microprobe. however, it was noted that the combined use of all the methods would be almost prohibitive!y expensive.
One of those in attendance at the meeting was Prof, Seymour Z. Levin of New York University, a recognized expert on miner.3logical clrnuistry and analysis. Some time after the meeting, 1 asked Dr. Lewin to undertake the analysis of samples of commercial talcum powder products for ashosto-' (particularly the chrysotile and tri.mnlj.Le varieties) by means of the X-ray dirfraction technique primarily, with additional work by o] Lieul microscopy as needed. He carried out most of this work during 197.:; to date he has examined 195 san.plas of talcum powders plus some miscellan eous samples fc- others at FDA.
Dr. Levin has given us reports on liis results from time to time but ve do not yet have a truly final report fiom him. Until we receive it , we cannot: publicize the incomplete ini ermati on in our possession. Dr., Levin has vi Iften tha L the final report: v 111 he ready `Sri thin a few weeks'* but he js a very busy man and our past experience suggests that if may not arrive, until a few months from now.
Page 2 - Dr. Lucile Adamson and Mr. Scott Lang
1 hold a high regard for Dr. Lewin and the scientific quality of his work; of course, it is always necessary to maintain a critical attitude towards the results obtained by sophisticated analytical techniques. This has been particularly true in the present case, where the small amounts of asbestos involved, and the presence of transitional and aluered mineralogical species, led to ambiguities in the data. In his eagerness to protect the public interest to the fullest extent, Dr. Lewin in certain cases interpreted borderline results as showing the presence of asbestos, In his earlier reports, but he later used a more conservative interpretaTM tion. He has spent a lot of time and energy in creative scientific work aimed at resolving the ambiguities (for which the public and FDA owe him a debt of gratitude) and he lias succeeded for the most part. As you may know, some discussion of: Dr. Low in 's earlier interpretation of the data was included in an article on asbestos in the Hall Street Journal of F ehrue ry 26, 1973.
Inasmuch as Dr. Levin's results are judged acceptable, subject to the above comments, we. have not undertaken a repeat survey. Because of the possibility that optical microscopy alone, may constitute an acceptable technique for the detection of asbestos in talc (and is more generally available than X-ray diffraction) we are currently making a comparison between Dr. Levin's results on selected samples and the results obtained by in-house FDA microscopists. After this comparison work is completed, a decision will b made as to the preferred procedure for detection of asbestos in talc. Details of the analytical procedure are needed for the official statement which Fife plans to issue on asbestos contamina tion of talc.
One more point should be noted, that FDA activities have already led to a substantial upgrading of the qua liny of talc used in cosmetic products. This is evident both from the results obtained by Er. Lewin upon reanalyses of a given product vhe: c repeat purchases were made at retailover a period of time, and also Iron discussions with a principal sup plier of talc who indicates the L ho now sells only ashes Los-fre.e grades of talc to the cosmetics industry.
With reform'' to your last question, FQA has undertaken extensive litera ture surveys on the carcinogenicity of asbestos and of talc, but the n sriLts thus, far do rot establish that talc .itself is carcinogenic.. We also have had discussions with members of the National C a n e e Institute, where \ orle is currently underway on carcinogenesis by fibers and rm i ex*a1s as well as other chemicals. As you probably realize, the mission, and iaril it ios of the National Cancc-i Institute are more appropriate than those of FDA ior rcso tvix.g the question of the possible care inogen rcity of pure Laic; also, a period of w.my years 'will be needed to obtain the ansver.
*f Page 3 - Dr Lucilo Adamson and Mr* Scot.! Lang
X trust that the above information satis lies your needs} and again ex press regret 'for the delay*
Sincerely yours
;i! v h/;
' // t},,hu y,,
Alfred Weissler, PIl, D,, Acting Director Divjs 3on of Colo rr, and Cosnveti cs Oxfice of Product Technology