Document gDw3XgzV4ZpVb97K3XyGyx2oN

FILE NAME: Talc (TALC) DATE: 1973 A u g i i DOC#: TALC112 DOCUMENT DESCRIPTION: Memo - Report of Meeting with FDA r - ' ' i*" V v ' Research. &E n g in e e r in g C e n te r / * A ugust i l , (197J , ; ' REMO FOR' FILE : - f ) l7 > ' " . % -1 V `\ - , I ' i . : : %# ? : , . : ` t F O A rjffi T IN G ASBESTOS N^COSMETC %ALCS-, ' y t- AUG0ST7-3t . 1^71. - WASHIGTGlJ i Di Ci.. - > >i *. * * '. - v. 1 . v : i T h e Ip u rp o se 7 arid l i s t ' o f; p a r t i c i p a n t s and ..d is c u s s a n ts ; in I h e 'E tta c h e d - tw o h a h a o u ts from; th m e t in g i | | \ I' , are given e .. t ; Siwnar^ ^ . s r 1. ? ? . / . t , : Dr.. R oer (HY4'.Dep.iM:&ent|pf': A ir R s iu r c e s ) `s e t i h e f b a s i / ft>r ' th e m ee tin g ; arid r itiE ra t h i s ?3mans* th at! t h | FDA: 1'. . ; 2.- 3. s p e c i f proceuires for . ^ y a l V a t i b g t t ' a i c ] ; , ; V ; . [. . 'y .VE'"',' [ ` l e v a lu a te c p s m iio p ; s f iy \ :X - - - deciide bn ythe cepialale' li m it s o? a sb e sto s; and, . . ; 4. l -iKiO ; . W H>p. - jtvftr'. CRMC-TALC-000034 BCAL-RJLEE0003265 <aVVv!.'r5/> . tirchi- ;? ' * 1& AugUBt 11, 1971 Paga -2 . FDA MEETING . > . ASBESTOS IN COSMETrc TALCS . - st - ' ' .,, .' ' , Vermont taljcs l (source? of, J s J ) g e n e ra lly r e l a ti v e ly f r e e of t r e - ? m o l i t e j o r o th e r. a 8ib e # 08/.m in e r a ls '. . ; . : . ];' ,1:. v' ' 4 , ' -Dr. Lewis Ji C ra lle y N ational I n s t i t u t e ; q 'g .cfccu p atio n al - f- f ;; '' y Safety.- and; H e a lth - C i n c i n n a t i , O hio i fI } - t ^ - V'.. i - . i . Reviewed d e f in itio n of - f ib e r " and r e la te d th e hazard to r e s p ir a - | , h i l i t y l and *tdste'- O f ^ to ta l|> x p o s tt'r e y ..lilritro d u ced . ag ain ,- th e- c o n c e p t j of-''iwavV p u b liab ed Study of i r-.-t- J-tos";f i h f -ihf'the^ ;-:% alcsyw is / ,;in ;if a c t oi^ yv i on th e ;known ;.got^y !p f / t a l c ^ d ep o sits'.,-; , ; < . - ; *'< ^--v ; . I--, "* :,v V ->-y' i f :| -vor ; -Irvin g J i v S e lik o f f :-;: ^ ... ijsih a C S ch o l -of M e d ic in e ,, >- ' 'S,' ! -4 .< ' * i -.J/ ui ^ it. ' ; i; , ~i ;.. ' ^ _ -*5s\ * .fn l low ! na ,hr'uoh It:6 M s He: hotediiEl%ltff d .7ys$ay $ t -t'aic#'^ k #S f (Al-ch;'.. -Env. ^Health--,. ' Voi; 4:'&3i 967),S u t fa te d ' itVwas h o^ -,n ecessarily e x tr a p o la ta b le to community ehvirojim ent. He n o te d ie x c e ss lung cancer in t a lc workers In th e, Gouvfernur, New Y o rk :.d istric t o f tr e m o lite t a l c . ; | He 'mphaiizd "th ^ ^ t i^ c 2 q f - ; S B ^ i^ j h 8 B 'it 8 in -asbestos fo r k e r s i m&W bAtT-i `t i ; k . !:>* . ic ir-itf' -.'iSi i*':'> % .* -viT'- ' S, / a -- / i, f ,lr - t.\ ,X . ' *. /-x - ' *v ii> ` ^ . v 'i .- ^ * 2fe CRMC-TALC-000035 BCAL-RJLEE0003266 ST' A ugust-11,1971 i'age ' 3 FDA.; MEETING .. i . a. , IN., COSMETIC,,TALCS,4. /, i':p a ui.- G ross I n d u s tr ia l-* H e a lth I 4' Foundation: -b4?'. 0 ' D escribed ^ n ia^ -ex p eriih e'h ts w ith ?t a l c h J b v ib u s y sd on phv- ' ? h i nL o d 3 Si l n j e c t ? d. i n t e n t i o n a l l y '- i t o `b c X li^ S o f a n im a ls . i d r M TM ^ ^ n g ra n u lo m a s . H e d e sc rib b d i n t e f tis a c h e a l in-;:: J i S ? ? t ype s o f .ta lc ( h ig h f n i c k e l , 1/ow n ic k e l, and o f f- th e - s h e lf cosm etic t a l c ) N o f ib r o s is a f t e r i c o n c l ! ^ ! ' ^ k v ^ ! ^ 0688^ am ounts used.-; H e-rioted Ia n W e b ste r1s h a rm fu l10nS,r *? f i b e r s m ust, be a t . l e a s t ' S- m ic ro n s lo n g t o b & : ' . Pr *^M orris . V> . J " f. Kaplan V - Consumers Union -- ---- -------------------------- Dr .'Ha^mdhdfei?- - l 'pg 1 His-t|re\/dew' of. th e l^ is ; <$? :p a x t 'u ls 't e s 'a n 'Vbio--' raedca| ;4re /^d?';^ ^ a4ed-C the.-.e^rStoSj>|&ttl^^ 'V" np/jfev^derice;:o&r,^er,eride--- * h a l | | ^ 2 t i ^ b r ' th ' a ^ r & i l ^ n h ^ S H S ' ^ , em?v:^ ,urbm # . ' r c inliaty-; tal, with afe p n ib o le im p u r ity ^ a d j b een -ricjjbd >ih"-ri-'e--'ont|bhe->!W e8t' .cb ast. '$-: CRM C-TALC-000036 BCAL-RJLEE0003267 ^' s XS? /,- A ugust '1 1 / i $ y i : . ' f ;. Page* "4 ` '. ! . FDA.MEETING, . " ASBESTOS tlN COSMETIC; TALCS; su b ject o f'k sb e sto s in :|.h jectab le drugs;and sta te d thaf.m ore th an ' one-fhalf {of-' i n je c t a b l e d ru g s in a su rv ey a t th e Mt. S in a i 'H ospital^PH artnacyf ;dontned. a s b f e s to s 'U r i- f o u n ts 'up*.to 1 m icro-; grain in v i a l . ' ; f ' ' i ' "| ! S. S p e il - Johns-M anV ilfe ; ' : Reviewed - a s te ^ to s tec h n o lo g y ;an d th e im portance of r e s p ir a b le . f r a c tio n .Vs'`t o t a l Sampljs . ' S u g g ested y e p ^ ra tio n ^ i n to a irb o rn e $#:* Ihdicatedvptesfence of- -------- - a d if f e r e n t Laaphibole} , |b u tL a |ll other-.,cosine|iC |ta.lc3 c le a n X -rayai ' ' ' _ 1 ` . *^, `t _K*`X'\ V ; 1. ` , V ' *~TiL` : - -1 '< *5 *' J, by. . ' ' ' i l Pr Sikx t -f* ^scopy t- /' n^ ^ Ssf?,: M Sr.- iir / J 9 - ; ntf-e 'M .w.. ^ .:v CRMC-TALC-000037 BCAL-RJLEE0003268 ir 3r I.f n- A ugust 11, 1971 i Page 5 _ i i ! . * FDA MEETli ASBESTOS', COS.'iETrc TALCS ' , ? , S' "; f ` ` - : I---, : microscopy; .I,ndic,a_t_ed approximately one/week work for com- plete catihg evaluation dt presence .o& a b ta|l8crbsVa|m-palned-.-' Showed ,,many "ghry'sile" slides- .indi|nofc' verified; by elettroni diif r^td*1^' Still,feels 'dfit'if i.cation df chry-j s o l i l e by sh a p e .;? # tp 9$ p e r - c e n t c e r t a i n ; / !.. f ' / " i* * - I Dr. Norwood; - Chaa^ - P fi^ r-f.t iCompany Pfizei-^tadlfirpro,-Montana 'indicated l l i g h | ;cito,or ite y. Angs trotoa;\ {rnp p ld s s e rp e n tin e ) wr'-s e n s itiv e X -ry d e te c to r s fo r ap p r x i- : m a te ly -0.5 per'-'cent-. ;y :* - l '"!:'. V, ' -/ l-4\ |v,/ ; ; Ili' .-'`s /-.-/f "q. ' 'X,. "I' 1; 55 i Dir. W ilson,iNMaasshidd;Vpf dinsbn'lfc J o h n s o n .:'^ n tr c e d `t e 'fi o p 6 iftg $ g ro u p r p r e s^nnt ft e ^ '; '^ J :|:n f c e x ^ tis . .*: {:. K " K>. T-. C an eer i- loIcsrdoiSchedi, i MiriesfeRsarch"-ihjttu.t.e1'y '' X Reviewed, p,, .io g f p h ic % r c lW n .'fib e r., i ' liSctron 'pr& aje''3f^ ' 1 ;.Shbwd]:y ; T :?: ;:j. Di:. '?G|w Gxg'er^TVMcCrohe';;;'. '-j ' --.R w its . i t c t i W ^ ^ ^ IT ' ^s'' ' ^ f e $ h ` f II * Ir-'.'T'1' i f ' .- I '.. a ,5 u- '-'>h .- ' t, ' ' vir' f e : : . CRMC-TALC-000038 BCAL-RJLEE0003269 : - .'.ilSf-H : " <*V* :-*&- r i August 11/ 1971,,. ^ * ; f i i ' FDA MEETING ... i ASBESTOS iil COSME; TIC TALC'S, ` ; r ''...' ; . .' J ; t 2' llydrom agnesi is jfib ro u ^ -irt form .:- D iam eter. o f 200 A ngstrom s j w ith a "hole"! down . t h e - c e n t e r , H y d r m ag h site is known p 1 o c c u r i n some* t a l c d e p o s i t s . Geiger.;1q u e s ti o n s , scijne o f i A rt Langeifc' 5 i d e n t i f i c a t i o n o f c h ir y s o tile : f i b r i l 3 . T h isi was a smofe sc r e n , b u t a good co u n ter o f f e n s iv e ;to Langer t ' :. fin d in g c b r y s o t i l e everyw here} . . ' .{ . . : ; . ;. } ; -, ! Dr... F . D P o o le y - ^ U n iv e rs ity ' o f S o u p . W ales | """.. ~i I .... i,... ~ ' ... ----- . ^ , Examined? J6>ff t a l c & BM t e c W g u e s , p o d d i n g heavy U g u id d e n - s ity separation in C entrifuge. A ll. fib ro u s c o n stitu e n ts w ee l i d e n t i f i e d a s t a l c by e l c t r o n 'd i f r a c t i o n . , . . 1 . V. f Dr. R. i F.- i l l e - Jo h n so li f, J o h n so n ; -U <= -j ' -, ! I 7 .J-'fv i-.T Showedibeaujti fu 1? ? f t a l c . Samples were madetby r e p lic a tio n ..p in g gold .p > llp iu m , p l a t i n g . f/ ' " " - | ' ' -i - <1 i .= f ' ' n r . w. F. N id h o lso n Mb'. ' S in a i- g g h o o i - l p l M p i ^ i g e s a le s p itc h Iro o s ld a' E ow U ev^ nd-lhigh y b |' s p d ^ . p ^ a m l f b r ^ u r v K i n l c l s m l t i c . & ! . . Th.; include p o la |iz p .|lg h tim p ro E p p y - p ^ ^ c h ^ i q u e would eam lnations and then possibl; -- - s a r j;. ./ Langei lartfo p . ~ ch ry so ti.le, I cu iisric i i c h o l i o h ' s- 4 > re i t o y J w 'e :fi> ro |ra ^ r i. n i t i M fl: i C . ' " u r v y : ; a f . ; i I ' ` . 1Aj .` ' ` i f M ito # t o the- V' XJ ^ . f . -K ' 'Ok yj 'ti l . '4 3y' I m 2. idy o f ,tH Mi. ^ ^ tp L p I'L lo r r ll U S in a i'- lu n g ,?jsurvpy K f c i S f u '^ n iS r in X, the i.lu n g siw ix h t a l c .usage? ,ind- >- " ` - * * ****** nj ?, . 3^ /^>/-7 4h? ! . v>*s:t CRMC-TALC-000039 BCAL-RJLEE0003270 ''"i: < I.v:. q August .H ', 1971 Page;. 7 - f FDA MEETING - i ' ASBESTOS IN COSMETIC:TALCS I IWPMI,! J ; a c o m p le te e p id e ra ia lo g Leal s tu d y o f th e lworke>rs m in in g and * ' p ro d u c in g c o s m e tic t a l p s . ** ' . \ i : i . .. . C. M aggiore -- Mt.{ S ih a il School of M edicine R eported on k t .' S in a i ,< lx p l|rato ry work tow ards th e developm ent o f in s tru m e n ta tio n f o r C o m p letely c h a r a c te r iz in g many and a l l ' fib ers-h n d p ftrtic le s ,'iri a-sam ple by*shape, s iz e , chem ical a n a l y s i s , 'e ^ c . ' He i n d i c a t e d th e need f o r a p p ro x im a te ly 5300,000 a n d -2 -tfe. 3. y e a r s f o r , d e s ig n and c o n s t r u c t i o n of,' a p r o to ty p e u n i t . . , j- .{ > s'. fePEIL , I : SS/rs. " , . A ttachm ents (2) cc: ' w. p.-; R a in e s; DH M. S w eto n ic,,D H ^ C.' S h a c k le r , Fi Ll;. P .uhdsack^ E, H,} F enner i J,. P . L einew eber , Fi 1e .hotedtby: c.; s|tre|b ; i- . ' ' f 'I' ? '>: i ft ' ''' 'f% "'j ' ` " <, 1*. ' V- ' - ' t - z ' *. <}' l '1' i ii 4\ - .Vl. J .X . 1 1 ' i. , I- - 1: f if i ' ylk: 4 4 , , \v' ,'ryi! ri 1 . ' 4' i \t I- ( , 't r- 'I / 1 - 1)v \ 4 , ,2:' A ' : f-. iti ' fI . - - i, > * . : .m, i - ;---***-i' , ` i .. y vv l :>.^1e . .i.' - 't , i1 c \- *,^'>4 r.^iSSte ; ' CRMC-TALC-000040 BCAL-RJLEE0003271