Document ZJxwgab0gEakG2YkgnLn16D7J

The Cosmetic, Toiletry and Fragrance Association, Inc. 1133 16th STREET. N.W.; WASHINGTON. D, 20Q5 -`202/331-1770 TELEX 69-2673 Jp.mcr H M'jriul Prrc.d-.-.'if NorWmeaen PFj-c, E^tri--n.StO-fhv.iDct.- March 15th, 1976 Mr.. Heins; J. Eiermanri _ Food -and Drug Administration 200 C Street, S.W. *. . Washington, D,C. 20204 On March 11th, 1976, Mr, Eierniann -- the CTFA Talc Subcommittee-mot to discuss the current sta tus of talc It was recognized'that a need exists o o r r i n g t o your a t t ^ t L n a -profile of the analyses f o r asbestos form materials in talc used in the U.S. production of cosmic., and toiletry products. the freeaem item e o n t ^ i n a t i t , by asbestos form materials of cosmetic talc products. Individual companies are .more, than willing to discuss the detailed data with you at your convenience- Norman F, Estrin, Ph.D. Vice President - Science NFE: j j " Attachments Avon products, inc. $ U F f F R N * V F W Y O R K l u i .0 l March 12, 1976 Dr* Norman E s trin CTFA 1133 15th S tre e t, N.W, Washington, D.C. 20005 Dear Norm: This i s to confirm our indication yesterday of our w illingness to disclo se to of, you al 1 and/or the Food lo ts of t a lc we and Drug Administration the re su lts of our analyses have used in our products during the past three years During 1973-a l l o f our-tale re ce ip ts were sampled, and aliquots were sent to McCrone Associates for X-ray d iffra c tio n analyses with the sp e c ific . request fo r confirmation of the prsence or absence of c h ry so tile . We did not specify other amphiboles at that time because our e a r lie r data indicated that they-.were present only ra re ly in the ta lc s we examined. A total of 1/v. samples of t a lc s used in our products were examined by McCrone during tnat year. The X-ray d iffra ctio n patterns are on f il e ..a t McCrone and can be - reviewed by authorized people.' .The results.'were negative.' / . Since February, 1974, we have analyzed about. 250 samples of ta lc receip ts -: in-house by D1A fo r ch ry so tile and IR for trem o lite. As mentioned above, , we f e l t that R fo r trem olite. was adequate for screening purposes, because of the rareness of Other amphiboles. The data from these analyses can be made a v a ila b le , a lso , i f needed.. The re s u lts were negative. - Please le t us know i f th e re .is anything e lse we can do to hejp resolve the question of asbestos: in cosmetic t a lc . Yours tru ly , .fULS ^ohn J . Travers JOT :mc .. c c : C. S, Rowland G, A. Sprott R. C. Reardon Central F ile Chesebrough Aotids Inc. R ESEA R C H LABORATORIES T R U M B U L L IN D U S T R IA L P A R K . T R U M B U L L . C O N N E C T IC U T 06(511 PHONE: 3 7 7 -T1DQ March 12, 1576 Drc Norman Estriri , . .' Cosmetic,. Toiletry & Fragrance Association 1133 _ 1 5 t h S t r e e t . , N.W. Washington, D,C. 20005 Dear Norman: For some-years, Chesebrough-Porid's Inc. has been concerncu about reports that some talcs-might contain ssoestoc. a. naturalise spurring contaminant. As "Ou Know, >'rc have, wiih CTEA,- and t h r o u g h -0T?A with .the FDA in d e v e l o p i n g s u i r a c l e and practical methodology.: to resolve _the very coupie.. c-m difficult task of identifying asbestiiorm fxoers in -- have also worked, closely with resuonsxole. talc .upp o identify high quality sources of talc. By the beginning'o f 1 9 7 3 , W^ f- -e-.-l-t t-h- -at -*practica.l me, thouol.oiv the. purpose- was applicable, i-.Since then, we na\e aull.^eo techniques described in'the attachment tc_ mc.;u, or^ talcs of three types that wc liavd been'using. -nese u from three different geographical areas. . :metic . I have reviewed the results- of. these analyses on the Iredmlng-lc-ti of these talcs used in recent production of ^saetn. ,;vnd . v a -.., products'in the United States. -The last 84 .reports, cuvtrin--, a ?h?ee-5ear period, are, .without.exception, negative for ohrysotlle- and negative for fibrous amph-ibol.es.. If It can be useful, we wouid.be pleased to discuss these data with scientists a t .the Food and Drug-Administration. - MB/bm end. Sincerely, V, l'V jL ^ lS~\ n.y Murray Berdick . . Director:of Regulatory Affairs- COLGATE-PALMOLIVE COMPANY 909 River Road Piscataway, N.J. 08854 March 15, 1976 Norman F . Estrin, Ph.D. Vice President . . The Cosmetic, Toiletry and Fragrance Association,' Inc.. 1133-15th Street, N. W. Washington, D.C. . 20005 Dear Dr. Estrin: Attached please find a summary of Analytical Data on 42 Talc .. Samples (representing 20 raw materials apd 17 finished products) covering the period 971 to present and examined by various tech niques by the Colgate-Palmolive Research and Development Analytical Department and McCrone Associates. - . ' Asbestos minerals were not detected in any of these samples, with the'exception of insignificant trace amounts found by micro scopic methods in three samples from 1971-1972, which is believed due to laboratory contamination. Other methodologies indicate the absence of any asbestos. The results of these analyses indicate to us that talc products produced by the Colgate-Palmolive Connany since 1972 are free of asbestos minerals when subjected to the. most sophisticated methodology available. : We have ascertained by inspection of the package and analyses of the product that the sample of Colgate-Palmolive's Cashmere Bouquet examined by D r . Langer of M t . Sinai-Hospital was manufactured prior to 1970. The Bauer and. Black Talc reported by D r . Langer, has not been manufactured .since the end of World War II. This company was acquired by Colgate-Palmolive approximately three years ago. . , .: : Very truly yours, t* X'! t f a Christopher H. Costello, Ph.D. Administrator Regulatory. Affairs C H C :mp Attachments March I d , 1976 To: Dr. C. H. C o s te llo From: J . P. Simko, J r. S u b ject: A n a ly tic a l Data on T alc Samples 1972-P resen t S in ce l a t e 1972 w hen-the p o s s i b i l i t y o f a s b e s to s in t a l c -was f i r s t r a is e d , RfD A n a ly tic a l has been engaged in r e -a n a ly s in g U .S. t a l c raw m a te r ia l a n d -fin is h e d produ cts fo r a s b e s to s m in e ra ls by th e most s o p h is t ic a t e d m e th o d o lo g y ,a v a ila b le a t th a t tim e. A n a ly ses were made on a sp ot *c h e c k b a s i s : T e c h n iq u e sused m house are x -ra y .d i f f r a c t i o n fo llo w e d by o p t i c a l a n d scanning e le c tr o n m icroscopy, i f n e c e ssa r y . X-ray is the b a sic screc-iu.no t o o l and exam in ation by m icroscop y i s made when p o s i t i v e v -sp o n s e s o c c u r . A d d itio n a l t e s t s on random sam ples were made by tr a ils m issio n e le c tr o n m icroscopy and s e le c t e d area e le c tr o n di ti.r a c tio n by an o u ts id e c o n su ltin g firm . F o rty -tw o sam ples (from dO raw m a te r ia ls and from 1/ f in is h e d products] , covering the period 1971 to the present., have been exam ined b^ th e s e v a rio u s tec h n iq u es.. A sb e sto s m in era ls w cre_not d e te c te d in any o f th e se w ith .th e 'e x c e p tio n o f . tr a c e amounts -in 3 sam nles- from 19''! - : . These l e v e l s are c o n sid er ed yeneu,ll>_ - n l u th e normal background le v e ls encountered wnen t h is m icroscop ic m ethodology is' employed, I t i s b e lie v e d th a t th e se trace amounts are due to' laboratory contam ination. A 'd eta iled tab u lation is a tta ch ed . JPS/ed tt Ko. of Samples Examined for Asbestos Minerals 1972-76 Method, TEM-SAED ;. Sample dates (yrs.) Raw Talc *5 ` . 1971-72 Cashmere Bououet **7 1972-76 X-ray plus microscopy (optical - SEMj- Sample dates (yrs.) 12 1971-76 11 1972-76 DTA Sample dates (yrs.J 6 1972 1 1972 sample 19 71 raw ta lc contained 10-100 ppm. chrysotile *1 sample 19 73 raw ta lc contained 1-10 rpm, chrysotile These level.,, A p re se n t po^sib background von tan. n a tio n **1 sample 197? Cashmere Bouquet ta ic contained <5 ppm. c h r y s c t i i h No araphlbole detected in. any of these. JPS/ed 3-12-76 * 1133 STREET, N.W., WASHINGTON, D C. 2005 202/331-1770 TELEX 69-2673 MEMRANDM James H.PrMresrHietUr1 Monrian F. Estrin, Ph.O VrCP Ycsrtferti--S^/fertce TO: FROM: DATE: Norman F, Estrin, Ph. Anita S. Curry March 12th, 1976 Jim Jenkins c a l l e d regarding t h e .letter you have asked for on cur rent talc analyses, -He wishes to inform you.as t o 'what they have been doing: 1. Mr. Clements contacted p r . Langer who gave n i m ' the code on th Coty Air spun that was tested.. . It turns out'that this was a July, 1?69 produc tion item. . 2 In 1970 Coty changed to a completely different * taic; since that time the supplier (WC&D) ha.s supplied letters to the effect'that they dc continuous monitoring- of production/ even . though individual.batches sold to. Coty may not be individually tested. 3, Coty has had tests- run on intermittent batches^ T at the Pfizer Laboratory in Easton,- Pennsylt a m a . These were done by X-ray diffraction and TEM. The results were all negative. Also, in the last week they have tested 1974 and 1975 lots. These too were negative. S C :jj CTFA v s m WL VSH TLXAl4fc VAF 139 C14 27) C.l-0)B216AS72)PD t w x cn-nao L3A Lgjg L-A 03/12/76 1424 RiS THE COSMETIC. TOILETRY AND FRAGARNCE ASSOCIATION. IN. 1123''f i f t e e n t h s THEFT, n. V. WASHINGTON. D. C. 0005 MARCH IS.' 1976 DR. MCRMa N ESTJUN ' VICE PRESIDENT - SCIENCE DE/R DR. ESTF-INs AS A RESULT. OF DISCUSS IDOS I HAVE HAD WITH LOUIS MJRIMC COKCE^MIMG THE MARCH It. 1973 CTFA TALC SUB-COMM ITT it. . -I WOULD LIKE TO STATU' TH-H-T VS HAV^. A CONTINUING PROGRAM 1 EXIST CUTS TO TEST OUR MONTANA GRADES OF TALCS THAT ARE LEINS OFFERED'TO THE.COSMETIC INDUSTRY- PRIOR COF.RESPOT'DE'-ICE BETWEEN 0UR3LLVE5 AMD 'H*_ _GEORGE V. 'SAMDLriUiL CHAIRMAN OF THE TALC SUS-CCHUITT-- . KAC ESTABLISHED THAT v s LAVI- TESTED 2. B39 Si^iPL^S F*ROM OUT; OCRS DRILLING PROGRAM AtID ST M-HAY DIFFRACT!JD PATTERNS HAVE HO SEEN AMT DETECTABLE .LEVEL.. OF. CH3YSvT.IL,F AMD TFF^CLITE- CUR X-RAY DIFFRACTION TZCHHX.aULS. i.E::L IM a c c c f d a h c s uir; t h e c t f a j -a - i m e t h o d o c t l u u d FCR USE UFFEH CTFi. SPECIFIC:.TJ ON5 F O R COSMETIC TnL C SINCE OUR OR I INAL I W E S T l G A T I C N AMD SUEUIS5I0N (i.UGj'ST A. 19 75) . 'IF HAV E V A L U A T E D h H ADDITIONAL FIFTY ' CNm TAN , PRODUCT!ON SAMPLES WITH-THE SAME 'OCCELLENT RESULTS. 'ME CONTINUE TO USE M-Ra Y DIFFRACTION TECHNIQUES AS OUTLINED 3i CTFA J-4-l. ' 'JS SHALL BE HAPPTY -TO CONTINUE TO COOPERATE WITH CTFA IN OUR t e s t in g p r o g r a m . VERY TRULY YOURS. CYPRUS INDUSTRIAL MINERALS COMPANY 555 SOUTH FLOWED STREET . LOS ANGELES... CALIFORNIA 900 7 1 TELEPHONE' C213) 459-3700 ' END ' iNN '' H. T. MULRYAN PRESIDENT 323PEST ' .CTFA WSH Ort" it i L--:-i! ;.-r .-.r.fi talc investigations Our investigations of talc dates back to.November 1972, whan the following samples were analyzed by McCrone Associates and round to be tree of any asbestos content: . Music Talc Aphrodisia Women's Talc Aphrodisia Men's Talc Flambeau Talc Woodhue Man's Talc Straw Hat Talc Tigress Talc Brut Talc Kiku Talc Woodhue Women's Talc Xanadu. T3l.c Zizanie Talc , 9-26-72 d-r-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9*26-7-2 9-26-72 9-26-72 9-26-72 9-26-72 In.November ,1.975, the following samples were and found to be free of any .asbestos content: ural hr' cAo-'h-1 bauaciates Brut Talc Brut Talc. Kiku Talc Kiku Taic Kiku Talc Xanadu Talc 3.4.75 20.6.75 11.11.75 24.4.75 3.7.75 20.6.75 __ On of March 9, 1976, McCrone Assoc, purchased Brut Talc, Lot #2585, which was produced in on a Chicago September store, one L5, 19/ 4 oz. container This sample was also found to be free of any asbestos content. FBtRG DIVISION -r - r a-;.s . -a BABY PROD UCTS COMPANY ^ofiHVon^ijcfttncii N E W BRUNSWICK. N J 0SS03. March 15, 1976 Dr. Norman F. Estrin Vice President - Science Cosmetic, Toiletries',;and Fragrance Association 1133. 15th Street, N.W. Washington, D.C. 20005 - Re: Examination for Asbestos In Talc Dear Dr. Estrin: The talc which is used by Johnson & J o h n s o n _is solely doriyed from its own mine in Vermont, where the ore ys/mined selectively and then-beneficiated by the.process of flotation. Shipments of this highly purified talc are.^ohtinelyex^inort by o u r o w n laboratory to verify the absence of asbestos mineral. .. Historically, Johnson &, Johnson has always been concerned about the M t a S i c a i integrity its t,lcs a,,d ey,a i t s ^ a r l ^ s s p e c i f firations have required the .examination for acicular part n...u. i . . m e n was roneously reported in 1971 that our powder contained a s b L t L L sponsored a scientific seminar of mineralcgical and a n a l l t w i l e a ? M ? s for the FDA to prove that our laid la not eon+ fl+edi with asbestos. At that time numerous samples we., e analyzed by experienced Consultants suchias- McCrone Associates, Collllto s choolof Mines, Prolessor F. f1. ^ y < o : ^ 1^ l ? i e Cra(olfM ):i hi! irao- iion analysis! dWferential thermal analysis, and transmissron electron microscopy. , . . During.-the period December .1972 to October 1973 93 J`B p ^ 0c* S d: S L r S ^ r a ? l : eXr S h S o ^ r L dsiipentine minerals .ere detected in any sample. Dr- N. F, E s t f i n C .T .F . . - 2 - MaPch 15, 1976 Beginning in October 1973, differential.thermal analysis was added to our specified requirement. Both, differential thermal analysis and X-ray diffraCtometry were instituted for the routine examine tid'd of sequential lots... A further 100 lots have since been examined, applying both methods to. each sample. Again, no amphibole r-r ser pentine minerals have been.detected, I would like to advise that we are. continuing to employ dit "eren.tial thermal analysis arid X-ray diffraetoiiietry in the examination of sequential lots for the detection of amphibole and serpentine min erals. ' It should be pointed out that we also maintain a worldwide-monitoring of- talcs used by our Johnson & Johnson affiliates, employing those same techniques. Finally', let .riie add that periodically, we. also submit sub-samples for Transmission Electron Microscope examination and these have always verified the absence oi asbestiform minerals. It is our understanding that you would wish to submit this information to the FDA, Please regard this letter as. lion-confidential., Sincerely yours, / George Lee ^ Director of Applied Hesecrch GL/mm V., BABY PRODUCTS COMPANY (jfcrflil VCIKtijoh11cu N E W B R U N S W I C K - N -1 O B 9 u 3 March 1 4 , 1976 A total of 3S samples Department ol Mt, S in ai H osptU t '_ s ^ au effort U , oubetanttn.e r*~ - " p u t r i i t," s t a f f o f th e 'It. S iu a i H o s p ita l- AmericonJ^Gffi^^i^ ' .- , ,,Ain-r fn 19 A m erican . ptc-nn C. il6- A total of 20 W 10 wre sunjeotwi to ^ " S S ' b y X-'rav rSrodu0TS and electron icr-cohtalaeo severa' K. 1.1;K- proo ut, K - . tn thP-'Mt. Sinai r e p o r t tiiat ' t' T his, i s and th a t an oth er f i v e o con tain ed 8 to * - 1 .^ b estow c o n ta in o c l l e s s th a n u.o a s h c s t o s . o f the pV' >d`.ic t s ;r dllCIS British Talcin^T^cKlU-cll;- P o o le; 1,^ f'it'4<d. one Similarly, IS products were ^inined b^ h,; cthor hand -.... produc-t. as containing nlltnop y - tromo M ts in th r e e products^ and__ m icr o sc o p e Han r o u t e d t I t sh ould he emphnaited that th e se in 1971 and arc not n c ,.e ssa i i1) l talcum p r o d u c tio n . . . ... rc ,.m picJ current American waiter c. me crone associates, Inc, CONSULTING: ULTRAMICROANALYSIS MICHOSCOPY SMALL PASTiOLe Pr.OB'-K-VS O U D .J Y A 't C 12 March 1976 Up , Norman Estriii _ Cosmetics Toiletries and Fragrances Association 1133 15th Street, N.VV. Washington, D.C. 20005 Dear T>r. Estrtn: This letter will amplify our recent conversation on-talc analyses for asbestos. Since'1971, Walter C. McCrone Associates, The., has worked With several producers and users of talc, the majority of them involved with cosmetic grades of talc. During this period wo have analyzed several nundmt talc _ samples for the presence of asbes.tiform minerals. 1 he mctnodologies Uscu have been principally X-ray diffraction and light microscopy using dispersion staining, although extensive transmission electron .microscopy examinations have been carried out for some companies. Subject to the approval ox our clients, wo ate prepared to make available to the FDA .through CfFA.tm. results of these analyses. We also have available retained samples lor mom of the analyses. Verbal agreement to release this data has been already given by clients accounting for probably 80-90ch of the samples; the others have not yet been approached. It would,, however, be improper for us to comment on specific samples until such time as written approval is received from our clmn-s, together with identification of those materials used in cosmetic production. The latter point is stressed because several of our ana lyses represent the results of raw material assessments which some companies initiated am might include talc ore bodies which are unacceptable.for cosmetic applica tions. ; I do not think, however, that I would be violating any company confidences if I were to comment on the asbestos in talc situation as wo saw it over the last 5 years. 1 think our view can be summarized quite briefly as follows. 2320 SOUTH hV C tl'dA N AVENUE < CHICAGO, ILL'NGI EOT,16-SiT/bV'mc. C.'iSLE C iA V iC riONE 12 March 1976 Bh * Norman Estrin Cosmetics Toiletries and Fragrances Association Page Two Some cosmetic talcs prior to about mid-1972 to early 1973 were found to contain amphiboles --principally-of th Tromolite-Anthcphyllite type at levels, determined by X-ray diffraction, of the order of 5-15% by"weight. Microscopical examination of these talcs, however, indicated that the bulle of this amphibole content (>99%) was non-fibrous, even applying the 3:1 aspect ratio criterion for a fiber, and hence not asbestos. No ehrysotile asbestos was found in thse talcs. Since 1973 none of the talcs which we have examined and winch have been identified to us as production materials have shown any detectable level:; of either ehrysotile or asbestjform amphibole. " Yours sincerely, P- In M. Stewart Manager, Electron Optics Group Companies contacted and granting verbal approval to release, inrbrmctiar include : ~ Avon Products, Inc. Bristol-Myers .Products Chesebrough-Ponds, IncColgate-Palmolive, Inc. Fabrge, Inc. Johnson & Johnson Windsor Mrnerals, Inc. Whittaker, Clark' & Daniels, Inc. . lmh 0 - D ' I i ' U G 1 VI* riJ EXECUTIVE 0FTIC E5 S O - P R K A V E N U E . MT W \ O R K . M / 10016 March 1 2 , 1976 Corporate Director of Quality * -- j'. ; it * *N . Dr< Norman Estrin. f>resident " Science 1133 ?ifteehthTStrJetyN \ FragranCe Association, ln c . Washington, D.c. 20 0 0s' Dear Norman: Of the taiinL e d U?71IZBT1B ^ i ap ^ dgJntir]a November 1 3 7 1 asbestiform minerals. S i n S ^ h S tfme " ? " ** of by x^ray diffraction anal?" s a b ju t S S e t, T 5 ** tasted received* In all instances--th- ^ Qf the lozs was no detectable as'bestifnrm^i '1RdlGated there samples. We also h a v e hsrl a nerals present in these' Whittaker,. Clark & D a n i e l s monitor the shipments of t4lc Ur suPPlierr ^ l0* ti3ielir amoantJ?tifrm rainerals and have found no d e L c t L l ^ ^ TM ^ to teatinatare Powder" tested b^thlTMount Qj ',zflf Baby and Was produced in June 1970. tie are^df t?roup." as coded !971 does not contain asbesliform L e r a S " Sincerely, S1"Ce l9ts RAM:mm Roderick A. Mundy C* B L E ~ SL!rlNAot '^0,, 5f-ioo ri,,, I 1T33 F ifi-tTdi:jUarters W a s h ir,9tonen^ N. w. . , U *C - 20005 0 a> !>.. ,,5!riii! In A u p ^ y i'! custom ers ut; P^3ram was f[fanouS a 3b4 t e 9 Ur cosTMetfc f ! ? * 61** our com ,, ^ < w T hr r D^ ` w -^ould be thr S ' 7t deterrfV de ta,Cs that to Pa,"'y r insure ion nee *>* m i c r c S f ,>la P<tivS ri; , r ent.that Eg? is ' ,A/ . . tSldei^ p e n d e r U ^ r eSt,n5 c F 0u,. aSfort`'ersoubjeoteci have also Us e o ' ' ' - borat c ie s . . ., ,,PrjdUcts wa3-sS ' Analvsf.r. UsecJ ther'tecj. .** * T e * s ^ r * s s ^-- .... . .-. -'''iw rfite , '"i.iai ,ur te eonta,,,, . in a k l ains rervmtK ^ '- . V . actln Sav ' t/.; c,'onsa^ ;; Walter c '\A ~ i ' r n e s , Rullo,t, , \ .'C Udl3 the > 0ijnw *? '*lc A-W'`=iat.,., Ch , 'na' p ' ; L bnat6r1`e s ^ a te i!' S t i n a S ' ^ n o f. C harles ft ^ Mabl`n: N ' f ^ -* * Vow, r o f - S e y tn 0 w a ^ nn.'r'9 ' N n ., r - C Orc!o n f.;r avv|n . \ avv v --. ' ''''"v >'-n.-v Wn' p n ,n ceton U h ^ e ^ O I t y . ^ c htinuec/ .' : . - De Bell. Si Richardson, Enfield, Connecticut ' Columbia S cien tific Industries, Austin, Texas' W e are w illin g to subm it th is inform ation to the com m ittee in d eta il to help substantiate their cla im s. ' Very tru ly y o u rs, ' ",' / ; . WHITTAKER, CLAR^K & DANIE L S, INC. .J > ... Frederick F. Roesch ' Executive Vice President ^ FFR/dm