Document 2jwjRJzZGqGGDrGjvo2Q6zQ6R

FILE NAME: Talc (TALC) DATE: 1971 Aug DOC#: TALC148 DOCUMENT DESCRIPTION: Memo RE FDA Meeting - Asbestos Cosmetic Talcs r,-.-,i.-' qfct zpv-"''y-'- Research.. * E n g in e e r in g 'C enter Augus t- 1 1 , 197] -\ : - MEMO FOtf FILE : . . ' i t '> \ t .:: i. , - .. AUGUST '! 19^1--- WftiSHiHpTN `D|C *; - : i; ' . /- ; , , .> ' ., I ! ' 4 Irtk cIp ts'an d ^ iscijfesarits ar^ gi^en : . t 1 r . ,, ' ; S&onary .^et hefbsifi.- t ^ l ^ p r ^ e i u i p i s , fo r ^ v a iW ti^ c jj^ a c ;-' 1., ] c. , e v a lu atte /oa&t.*t 4 * f- I- 4 T ' ^ d ecid e on i h e a ccep ta b le; l i m i t s o f a lb e s 4 ' ' ' ; :" ' ' ;,' and. ban th e ? s ie : o f th o se> ccs uhA ccep tab le- .%:'( ..; ic t a c s i wLch they deemed , h i "' " A 4*. 4 ; I :-J'. t- , * > > , ' v* ' , V 3B S -Sir ___ *C.. t Ex.6068-1 CPC-WINKELTRSCPT00001496 AuguBt 11, 1971 ' Page.. :'2- FDA MEETING . f .. ' ASBESTOS IN COSMETIC TALCS Vermont t a l^ e i(sb,urce of-J&vT). ^ e ir ie r a lly r e l a t i v e l y f r e e o f t r e - m ol.ttei or oth er a sb e sib s, m in e r a ls . ' .f "t ' ` :t. . -Dr. Lewis C r a lle y : f- N a tio n a l. In sti^ lu tef. p'f;t c fc c u p a tio n a l ? - - jr . y- "- %. Safety, andHealth} ' Cincinnati, Ohio . ); .R eview ed detf ir t it io n , o f "fibei|":; and r e la t e d t h e h azard to r e s p ir a - k rb i l i t y |a n d ' tlrae'i d ^ t o t a l | `iMcpd(B^re ' . In tr o d u ce d a g a in t h e .co n cep t c of- oubli^hed study of S***,1- |;- ' J?; r-V-1- .; -to a ;riper-, in;'. tne8e;^ aioss:w asv -.;iw';trac.t vona.y-3 a *- pro 'on' theIknowri':gebiogy'i'of, t a l c id epdaitsi;. "f .. ', ' t -.'.v- '! -Vv'tv. i - V ' -f i - ' f f i /, w ^ ^' - . 4; . r &- it. .-r.5.. Ai.ofc;.-.Irving-:Cf. Seiilfoiif^ %ihail>ScKo61.-of M edicinej - Ex.6068-2 CPC-WINKELTRSCPT00001497 T" ' August'11,; 1971 tage ' 3 . FDA'MEETING v - ; , ; v ' .ASBESTOS C O S ^ ^ IC , TALCS . f & %* % .-'siisfe- r ' - .. w, .. - D r :1P au l.G ross I n d u s t r ia l^ H e a lt h F oundation;, . f - ; ; o e s e tiS W 'a ih iJ ia i'-expe.rimehfc' w i t h'?*t a*l c ' v i b u s l y Used oI wn i -peh'yws ic ia n s * g lo v e s ! in je c te d in t e n t io n a lly lrt^o b e l l i e s of a n im alsThese produced no granulom as. H ecdescnbed in te rtr^ ic h e a l i. je c tio n s of1ham sters;w ithV th ree. types o f ,, ta lc J ^ S i s a f U r * n i c k e l ; and o f f - t h e - s h e l f c o s n ie tic t a i c ) ... No - f t g r , two. y e a r s, d e s p ite . e x c e s s iv e amounts u s e a .r He- n o te d -r a n Webjteir con clu sion s* that;; f ib e r s must.- be a t . l e a s t ; 5- m icrons lon g t o be^, harm ful. : : y- : ; ; . >; . Y . - .1 ,i "'if' ' . ) * f v *., -* p r . iM orris ;Kplh - Consumers Union * 'i'l ' - H- Dr.-HrmnV-E^.'?-1' FJDXy in a c t i v e -Jfl" and; S.el 1X0 t B ' in .31.?./ Sith a fc ib ri;b y & n 6 i% isith a ^ . fib e r ibonterit,$d|Waer-- w h ich -o rig in a ted ;Perins^jlvania|Ser.i5bhtine |e l t ..- 1 . t -* 'i>`'~~:V . At 'Y. " 5t**s "'f, <. Williato Vi. S&aeni&rg .-^FPA~^ .;i r Y p ry i s .. - !'i'ari^ie'-:'vbhe' y;:-Y. sV'iWcrtir'r'Y % I ^ ihd; ofid i t s ; ; ' i h ^ e ia s ^t; from t h e * v. i'V- ... ^... I ;Y -Y'' . ; - i : - Y .1 i t y;,:- y' & ' ' ' "*71 ' " fil ' '* : Ex.6068-3 CPC-WINKELTRSCPT00001498 rii'-ssS'*/-,r >**$" ** August 11 > 1 9 7 1 r Page? "4 1 " ' PDA .,MEETING.. . ., , Asbestos ;m . cosmetic t? s u b j e c t ,o f A sb esto s in .n je c ta b le d ru g s and s ta te d thatCmOre than- o n e -^ ia if jof- i n j e c t a b l e d ru g s i n , a. su r v e y a t th e Mt; S in a i . iH o sp ita l^ h a i^ a cy rd o n ta w n ed - &sbfestoa` in-aunounCs up` t o 1 m icro-- grain, in A viaif> "' X. f . '''! . S > S p eil - Johns-M anville ' i' Seviewed ls b e ^ to s techn ology; and th e importance of r e sp ir a b le . . f r a c t io n ;Vs 'r.total sampl&. Sugg^ested l e p a r a t i q n r in t o airb o rn e sample :or=f u s e l o f :"slthuiSted - t e s t s " 'iw ifch'^ ersoiiaii saifiplersVand'' cou n tin g .by.lA ^lB /W th'c^s^bsihgl.rec^gni'^ia'. TL\^ withfiari;. "dxpo-; sure ".'time'" f a c t o r . i v'v 1 "i :T*1" 1f 1 .t ' . Tmat'eri'a'l's ,v- , , \i v} ><' >/ -'it V; ,s\ V '"A v ' X ' `.^T; -:V*'".''v ',. ' i v ^^EinDhasi^ed ^heed ^fdr't^'4mi!niriia f o r fiLbrousAAistratiilXxf X -r a v s 'in d i -- JRft*V.? Si1- 'W ^ f y 1?: IV -?* 'm+mt*.ww? Sfc-.u'S , ,. urie fof.X-ray itetecti-on:'wl|kh *0.5;jpir tTent' detectable. indic'atfedr]pi|d,sience o^--''Mq r o d i ^ l l t j s M|-iif-'on^>^1^4ain^'i4* (probably a d iffe r e n t iM phibol^) otH4 r - .|c o ^ b ^ io '^M..lc9 ' c l e a n by. It X V ; p t y ^ l v a l i i ^ r V ?,'% ' I ' -jSedtSv .tfcMUahtmlor^idreb^.:^ e r e !'heeeBsibfV4t^anOT?fffial&Ytel'eotrbn' Ex.6068-4 CPC-WINKELTRSCPT00001499 m* - 'it %: August 11, 19.71 sty Page 5 .. . FDA MEETI ASBESTOS; COSMETIC TALCS .$,v \i V. v ' * *-. ' . ,- s .-> ; t 44 ti' i- . *. :. V :. f i . P f i x ^ . ' t a l ' ' r i ^ ' ^ n i ^ - ^ ^ * ^ i n d i c a t e d . ^ l i g h ' ^ c b i o r i t e ', ; j im p u r ity , b i t :iw^'.aip^'ib|rl&',4 '. S u g g e s te d X -ra y ~ j|to ^ e d b y . , _-- ul ^s^^v'^vATn4^'iii -arAivcie bv .x^r.aV;yeniission.,Agree .. plus serpentine) w ere'se n sitiv e ray .m ately fO.5 -per; 'cent-, | approx i- .t - -i ` .'-W'i: or. W ilson .group -pres.nt'jmgj.iJfiJ'nt,ere^ts. ^ *s / T-: V -- .<. I'. wl- t'C .C a n e r I-:' ^ li^ r l.S c)ii< s^ i'v ^ v ;M in es'sarp > i'-riS ^i,tu ^e ; !^ . ;; Reviewedd >p , _i o g ^ p b i c , a i d ;% ljfp 'tr o n "p r o ^ s/stu d : clean ffiibbee rrs l"; I?." V :f V} .: . |. f 'y '|- ..p, r'Qne .: y " T -."Rev.i-"e'vJ^-a, tT-, tnJmetiihSi! .f -. " EM d e i ~ i h t i ied vi's'- ,lo i;i ;d l ^ perlaa-:';' y '5 y . y y - . y f \ j f % . * : Ex.6068-5 CPC-WINKELTRSCPT00001500 . <*#&$ ; ^S1 fv *: *-#v .Vagus t U , .1971.,; caa 63 - 1i f FDA MEETIN ;' 1 ASBESTOS l COSMETIC : : " | TALCS 2'. Ilydromagnesitfe i s fib rou s.- i n form Diameter. o f 200 Angstroms w ith a "hole'i down th e c e n t e r . ; Hydrdm agnesite i s known t o . occur in somei t a lc , d e p o s i t s . - G eicfexv-questions sdme o f j Art L a n g e i's^ id e n tific a tio n of chirysbtile: f ib r il s . .T h isi . was a .smoife crfeen, but a good cou n ter o f f e n s iv e ;to Langfer find ing clirystatila' everywhere'. ; ' J Dr.. F. Pi P ooley - ^ U n iv e r s ity 'o f Soutte.W ales T m. Examined. J j t a l c % EM' te c h n iq u e s , 'in c lu d in g , heavy l iq u id s i t y se p a r a tio n in la. C e n tr ifu g e . A l l .f i b r o u s c o n s t it u e n t s i d e n t i f ie d a1s t a l c by e l e c t r o n ' d i f f r a c t i o n . ; den-r w ere b Dr. R. ; F, ftfelle - joh n sob & Johnson ; ; -I "0 'V' % '* * ' ?. -, { ShpW edi'beajtifull elcb xq n 'm icrograp K S .^ f^ r'd -^ d ;'up.Jp|latablets, o f - t a l c . S am ples w ere m a d ^ b rei^ iQ i'!^ .;jis_ n q .gbldk'phll^ddiUra ; f plating.?/ ' . 'i- ; ; '.Jr. -7,f t;, ,v ? ; - . ' ` . < } ' `T-- -x \k.--A- :=-, - A. < ' '-X' Dr. W. F . N ic h o ls o n \ 4'* VMtf7' Sinar.- gcho'ol'dfrM edi<jih include polaM z^d lig h t .|rfos(|pp dnd then p o s s ib ly ; l5e c ^ ;;j^ q r o a c 9 p y |.p l :^ ^ i `f4fe% icin ' -?'i `'n eces sary, Lanqe|-.q6esfcibs|whet'he -In' f i b r i l - leiciit.co 'fd ^ w ^ e1*il^ C i^ -^ h w e^ ivi's.ls^ ii^ i`<i: S>ex m ille d ,N ic h o ls o n ' s' ts r ^ t e n s v e p r o ^ t a ^ r b d e V '. 'ln. n itip i.^ u x V e y : ` |7 7 < v *.''v. J j v ' 1 t o theV - s t a t i l s t i i a l s & d y ofc th Mt\ S iim i;iu n g . : S u r v ^ siun^les^ o f - New yb rJ ^ p n p p ^ t o C o r r e l a t e f ih e r '.-andj.'talc C o n te n t in th e l l u n g ^ w r t h t a lic s a ; .and',- - %, . 7;' ,] .*7 7 f ' ' ' Z :!< -i ' ' $ :J V I I^:C .-'iL Ex.6068-6 CPC-WINKELTRSCPT00001501 CPC-WINKELTRSCPT00001502