Document Dd0jGOpbbK6JbQpbap2Y4vNmQ

The Cosmetic, Toiletry and Fragrance Association, Inc. I I ISft STREET. N.W.. WASHINGTON D C. 2QCW 20J/3J1-IT7TJ . TELEX 9-2675 H Mcmit PittH&lnl NormjHl f , Estfn. Ph.Q. H u tntHftnt--Scronc March 15th, 1976 Hr. Heinz J. Eiermann Food and Drug Administration 200 C Street, S.W. Washington, D.C. 20204 On March 11th, 1976, Mr. Eiermann -- -- t h e C T F A T a l c S u b c o m m i t t e e m e t t o d i s c u s s t h e c u r r e n t s t a tus of talc. It was recognized that a need exists to bring to your attention a profile of the analyses for asbestos form materials in talc used in the U.S. production of cosmetics and toiletry product*. The attached letters demonstrate responsibility of industry in monitoring its talcs. We are certain that the summary will give you assurance as to the freedom from contamination by asbestos form materials of cosmetic talc products. Individual companies are more than willing to discuss the detailed data with you at your convenience. Cordially, N o r m a n F. Estrin, Ph.D. Vice President - Science OTEJJ Attachments FISHBAINWCD-00000001 \ / ) The Cosmetic,Toiletry and Fragrance Association, Inc. 1 3 3 t6 lh ST REET , N.W,, W A SH IN G T O N , D.C, 2000S * 202/331-1770 * T E L E X 89-2673 A l M i H. Merritt Norm en F. Eatrtn. PhD . Tt** Sewce MBMORAMDUM TO: FROM: PATE: N o r m a n F. E s t r i n , P h . D , Anita s. C u r r y March 12th, 1976 J i m J e n k i n s c a l l e d r e g a r d i n g t h e l e t t e r y o u h a v e a s h e d fa? A H (#P- rent talc analyses. He wishes to Inform you as to what they have been doing: 1. Hr. C l e m e n t s c o n t a c t e d Or. L a n g e r w h o g a v e h i m the code on the Coty Airspun that was tested. It turns out that this w a s a July, 1969 produc tion item. 2. In 1970 Coty changed to a comple t e l y d i f f e r e n t talc; since that time the supplier (WCiD) has supplied letters to the ef f e c t that they do continuous monitoring of production, even though individual batches sold to Coty may not be individually tested. 3. C o t y h a s had tests r u n o n i n t e r m i t t e n t b a t c h e s at the Pfizer Laboratory in Easton, Pennsylvania. These were done by X-ray diffraction and T EM. The results were all negative. Also, in the last week they have tested 1974 and 1975 lots. These too were negative. ! ASCijj ^ u ntffT EXHIBIT * W CD-106 A von PRODUCTS, m e. s u m * H HEW Y O R K ro iD I March 12, 1976 Or. Norman Estrin CTFA 1133 15th Street. N.W. Washington, D.C. 20005 Dear Norm: This 1s to confirm our Indication yesterday of our w illingness to disclose to you and/or the Food and Drug Administration the results of our analyses of a ll lo ts of talc we have used In our products during the past three years. During 1973 a ll of our talc receipts were sampled, and aliquots were sent to HcCrone Associates for X-ray diffraction analyses with the specific request for confirmation of the presence or absence of chrysotile. We did not specify other amphiboles at that time because our ea rlier data indicated that they were present only rarely in the talcs'we examined. A total of 170 samoles of talcs used in our products were examined by HcCrone during that year. The X-ray diffraction patterns are on f ile at McCrone and can be reviewed by authorized people. The results were negative. Since February, 1974, we have analyzed about 250 samples of talc receipts in-house by DTA fo r chrysotile and IR for tremolite. As mentioned above, we fe lt that IR for tremolite was adequate for screening purposes, because Of the rareness of other amphiboles. The data from these analyses can be made available, also, i f needed. The results were negative. Please le t us know i f there I s anything else we can do to help resolve the question of asbestos 1n cosmetic talc. Yours truly. JJT:mc Ce: C. S. Rowland G. A. Sprott R. C. Reardon Central File r FISH B A IN W C D -0 0 0 0 0 00 2 Chesebroughfonds lac. M I E A R C H LABORATORIES T R U M B U LL IN D U ST R IA L PARK, TRU M BU LL. C O NN EC TIC U T 06811 PHONI-B03 *77-7100 March 12, 1976 Dr. Norman Estrin Cosmetic, Toiletry &. Fragrance Association 1133 - 15th Street, N.W. ' Washington, D.C. 20005 Dear Norman: For some years, Chesebrough-Pond's Inc. has been concerned about reports' that some talcs might contain asbestos as a naturally-occurring contaminant. As you know, vie have cooperated with CTFA, and through CTFA with the FDA in developing suitable and practical methodology to resolve the very complex and difficult task of identifying asbestiform fibers in talc. We have also worked closely with responsible talc suppliers to identify high quality sources of talc. By the beginning of 1973, we felt that practical methodology for the purpose was applicable. Since then, we have utilized the techniques described in the attachment to monitor incoming cosmetic talcs of three types that we have been using. These three are from three different geographical areas. I have reviewed the results of these analyses on the incoming lotB of these talcs used In recent production of cosmetic and toiletry products In the United States. The last 8A reports, covering a three-year period, are, without exception, negative for ehrysotile and negative for fibrous amphlboles. If it can be useful, we would be pleased to discuss these data with scientists at the Food and Drug Administration. MB/bm end. M u r r a y B e r d i c k " Director of Regulatory Affairs  n J CD4 (j. * O.n; t/`if" 3 0 20; rcuections ana snowing no iino la toc 1 4 . G A chlorite region la n e c e s s a r y and suinclcnt evidence (or the p r e s e n c e of chrysotilo. A U n e at 1 4 . G A la addition to, and of tho p r o p e r Intensity relative to,the T . 3 A and 3 . G 5 A lines Identifies chlorite rather than chrysotilo. W h e n tha x - r a y evidence la equivocal, optical crystallography m a y bo U s e d to confirm chrysotilo. Positive Identification will then be b a s e d n n the k n o w n morphological an d optical properties of chrysolile. T h e n o r m a l f o r m of chrysotilo la a parallel bundle of long fibers, e a c h a hollow cylinder only about 2 2 0 A In d i a meter. It la roonoclioie with y ranging f r o m 1. 5 4 5 -- 1.556, p f r o m 1,539 -- 1.559 a n d or f r o m 1.532 -- 1.550. T h e sign of elongation Is positive since y Iles nearly parallel to tho length of the needles. T h e birefringence Is about 0. 0 1 5 hence a 5 p m thick hundlo will h o w a retardation of 75 a m (gray). T h e birefringence of a 2 p m thick bundle of . chrysotilo libers w o u l d be barely detectable e v e n with a. first or d e r r e d plats. Dispersion staining Is a sensitive an d spcifi m e t h o d (or long-fiber chrysotilo, la IhcCargillc high dispersion liquid n Zj5 * 1.550 m o s t chrysotilo fiber bundles s h o w >. colors la the b l u e - m a g e n t a region with the central stop lor the vibration direction parallel to the length a n d In the blue for vibration directions . crosswise. Unfortunately, to a preparation of quartz particles about 10% will tie In position showing the s a m e t w o colors for vibration directions 90' apart. T h e s e ca n usually be Identified as quartz b y m o r p h o l o g y o r b y tho fact that the s a m p l e contains m a n y other particles of similar m o r p h o l o g y but sh o w i n g blue central stop colors In all positions of stage rotation. All chrysolite fiber bundled are constrained by shape to lying flat,hence always sh o w i n g both blue (crosswise) and b l u e - m a g e n t a (parallel to the length) for central stop colors, T r c m o l l t e -- N e c e s s a r y a n d sufficient evidence for the presence of trcmolltc is an X - r a y p o w d e r diffraction pattern with linos at 8,4 Q . 1 A , 3.27 O.O S A , 3.03 * 0 . 0 3 A A n d 2.92 O.OSA. (Note: zinc a n d m a g n e s i u m stcarato m a y Interfere at 8 . 4 A a n d calcltc H3.03A.) . t I When the x -ra y evidence Is equivocal, optical crystallography m a y be used to verify the presence of trcmolitc. Positive evidence will then bo based on accepted morphological a n d optical properties of Lrcmotitc, T h e c o m m o n f o r m is monocllnic r o d s elongated nearly parallel t o y (about X.G3) but with oblique extinction of 10-21' for crystals lying on the 010 face. T h e optic axial plane Is 01<lhcnce o (about 1.G0) Is also c h o w n on tho 010 view. T h e v i e w show i n g p (about 1.G1S) and y ' (about l.G3`) s h o w s parallel extinction, T h o optic axial angle Is about 80" with a negative sign and w e a k dispersion, v > r. Polarization colors ar e m o d e r a t e and approximately 100 n m (gray) for a 10 p m thick r o d In all cro s s w i s e orientations, 200 n m (yellow) for a 3 0 p m thick crystal. Characteristic dispersion staining colors are obs e r v e d la Cargilic high disper sion liquid 1 .COS: about 430 n m 1$ X 0 for y,blue-violet with the annular stop an d yellow with the central slop; about 490 nm for fi, bluo-grccn (annular stop) a n d golden m a g e n t a (central stop); and about GOO nm for o . yellow-orange (annular stop) and blue (central *?). . ' . * -f i FISH BAI NWCD-00000003 r if COLGATE-PALMOLIVE COMPANY 909 River Road PiBeataway N.J. 08854 March 15, 1976 N o r m a n F. Estrin, Ph.D. Vice President The Cosmetic, Toiletry and F r a g r a n ce 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 S a m ples (representing 20 raw m a t e r i a l s an d 17 finished products) covering the period 1971 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 tale products produced by the Colgate-Palmolive Company 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 b y Dr. Langer of Mt. Sinai Hospital was manufactured prior to 1970. The Bauer and Black Talc reported by Dr. Langer has not been manufactured since the end of World W ar II. This c o m p a n y wa s acquired b y C o l g a t e - P a l m o l i v e ap p r o x i m a t e l y three years ago. Very truly yours. CHC:nip Attachments C h r i s t o p h e r H. C o s t e l l o , Ph.D. Administrator Regulatory Affairs M a r c h 12, 1976 To: From: Dr. C. H. C o s t e l l o J, P. Simko, Jr. Subject: Analytical Data on Talc Samples 1972-Present Since late 1972 when the p o s s i b i l i t y of asbestos in talc was first raised, RED Analytical has been engaged in re-analyzing U.S. talc raw material and finished products for asbestos minerals by the most sophisticated methodology available at that time. A n a l y s e s w e r e m a d e on a s p o t - c h e c k basis. T e c h n i q u e s used inh o u s e are .x-ray d i f f r a c t i o n f o l l o w e d b y o p t i c a l and s c a n n i n g e l e c t r o n m i c r o s c o p y , if n e c e s s a r y . X - r a y is the b a s i c s c r e e n i n g tool and e x a m i n a t i o n by m i c r o s c o p y is made w h e n p o s i t i v e resp o n s e s occur. Additional tests on random samples were made by trans mission electron microscopy and selected area electron diffraction by an outside consulting firm. Forty-two samples ffrom 20 raw m a terials and from 17 finished products!, covering the period 1971 to the present, have been examined by these various techniques. Asbestos minerals were not d e t e c t e d in any of the s e w i t h the e x c e p t i o n of t r a c e a m o u n t s in J samples from 1971-2. These levels arc considered generally below the normal background levels encountered when this microscopic m e t h o d o l o g y is e m p l o y e d . It is b e l i e v e d that t h e s e t T a c e a m o u n t s a r e d u e t o l a b o r a t o r y c o n t a m i n a t i o n . A d e t a i l e d t a b u l a t i o n is attached. JPS/ed Att. FISH BAI NWCD-00000004 .> */ Ho, of Semples Enmilnad for Asbestos Minerals 1972-76 Method T3J-SAZD Sample dates (yrs.) X-ray* plus microscopy (optical - SlDi) Sample dates (yrs,) m Sample dates (yrs.) Rav Talc *5 1S71-72 12 1971-76 6 1972 Cashmere Boiiouet ##7 1972-76 u 1972-76 1 1972 *1 senile 1971 rax talc contained 10-100 prpnu chrysctile *1 sample 1 9 7 1 r a w talc contained 1-10 ppm. chrysotile These levels re- present possible background con- . tamination **1 satple 19T2 Cashmere Bouquet talc contained < 5 ppo. chrysotile Bo Rmphitole detected in any of these. J?S/ed 3-12-76 -t 'CTFA V5H W VSH 1LXAl'4B VAFI39( 1427) (1- 0 1S216A0T2TPD 03/12/76 1424 TVX CIMI S3 L S A 00 L O S A C A m s THE COSMETIC. TOILETRY AND FRa GABNCE ASSOCIATION, 1133 F I F T E E N T H STREET, M. V . ' W A S H I N G T O N , 0. C. 0 0 0 5 IN. M A R C H 12, 1576 ITU N O R M A N E S T R I N VICE PRESIDENT - SCIENCE EEAR DR. ES T R I N 1 AS A R E S U L T OF D I S C U S S I O N S I H A V E H A D W I T H L O U I S M U R I N O C O N C E R N I N S T H E M A R C H 11, 19 7 6 C T F A T A L C S U D - C O K H I T T S E MEETING. I VOULD LIKE TO STATE THAT US HAVE A CONTINUING P R O G R A M Itl E X I S T E N C E T O T E S T O U R M O N T A N A G R A D E S OF T A L C S T H A T A R E B E I N G `O F F E R E D T O T H E C O S M E T I C I N D U S T R Y . PRIOR CORRESPONDENCE BETWEEN OURSELVES AND MR. GEORGE V. S A K C L A N D , C H A I R M A N O F T H E T A L C S U B - C O M M I T T E E , H A S ESTABLISHED THAT VE HAVE TESTED 2,39 SAMPLES FROM OUR CORE DRILLING PROGRAM AND BY X-RAY DIFFRACTION PATTERNS HAVE NO SEEN ANY DETECTABLE LEVELS OF CHRYSCTILD AMD TREVOLITE. O U R X - R A Y D I F F R A C T I O N T E C H N I Q U E S A R E IE ACCORDANCE VITH THE CTFA J-4-1 METHOD QUTH11ED FOR USE WIDER CTFA SPECIFICATIONS FOR COSMETIC TALC. S I N C E C U R O R I G I N A L I N V E S T I G A T I O H A N D S U B M I S S I O N ( A U G U S T 6, 1975). V E H A V E E V A L U A T E D AN A D D I T I O N A L F I F T Y MONAtAil PRODUCTION SAMPLES VITH THE SAME EXCELLENT RESULTS. VE CONTINUE TO USE X-RAY DIFFRACTION TECHNIQUES AS OUTLINED BY CTFA J-4-1. V E S H A L L B E H A P P T Y T O C O N T I N U E T O C O O P E R A T E V I T H C T F A IN OUR TESTING PROGRAM. VERY TRULY YOURS. FISH BAI NWCD-00000005 . CYPRUS INDUSTRIAL MINERALS COMPANY 555 SOUTH F L O U E S ST R E E T LOS ANGELES, C A L I F O R N I A 900T1 TELEPHONE (213) 489-3700 END WJNN H- T. M U L R Y A N PRESIDENT 323PEST CfA VSH TALC INVESTIGATIONS Our investigation of talc dates back to November 1972, when the following samples, were analyzed by McCroite Associates and found to be free of any asbestos content: Music Talc Aphrodlsia Women's .Talc Aphcodiaia Men's Talc Flambeau Talc Vcodhue Men's Talc Straw Nat Talc Tigress Talc Brut Talc Kiku Talc Woodhue Women's Talc Xanadu i'alc Zlzanie Talc 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 In November 1975, the following samples were again analyzed by MeCrone Associates and found to be free of any asbestos content: Brut Tale Brut Tale Kiku Tale Kiku Tale Kiku Tale Xanadu Tale 3.4.75 20.6.75 11.11.75 24.4.75 3.7.75 20.6.75 On March 9, 1976, JlcCrone Assoc, purchased in a Chicago store, one 4 oz. container of Brut Talc, Lot #2585, which was produced on September 15, 1975. This sample was also found to be free of any asbestos content. FfiBEHGE DIVISION 1$ R A ILR O A D AVENUE. RID GEFIELD, NEW JE R S E Y 0 ?6 5 7 |201) 94&-SAOO ___ + M B V PRODUCTS COMPANY mi on N EW BRU N SW IC K. N J, 0 6 9 0 3 M a r c h IS, 1976 Dr, N o r m a n F, Estrin Vice President - Science Cosmetic, Toiletries, and Fragrance Association 1 1 3 3 1 5 t h S t r e e t , N.lr. Washington, D.C, 20005 lie: E x a m i n a t i o n f o r A s b e s t o s I n T a l c Dear Dr. Estrin: T h e t a l c w h i c h i s u s e d by J o h n s o n Si J o h n s o n is s o l e l y d e r i v e d f r o m its own mine in Vermont, where the ore is mined selectively and then beneficiated by the process of flotatiop. Shipments of this highly purified talc are routinely examined by our own laboratory to verify the a b sence of asbestos minerals. H i s t o r i c a l l y , J o h n s o n Sc J o h n s o n h a s a l w a y s b e e n c o n c e r n e d a b o u t t h e mineralogicai integrity of its talcs and even its earliest speci fications have required the examination for acicular particulates. Wh e n it w a s e r r o n e o u s l y r e p o r t e d in 1971 that o u r p o w d e r c o n t a i n e d asbestos, we sponsored a scientific seminar of inineralogical and analytical e x p erts for the FD A to p r o v e that our talc is not c o n taminated with asbestos. At that time numerous samples were analyzed by experienced consultants such as McCrone Associates, C o l o r a d o S c h o o l of Hines, P r o f e s s o r F. D. P o o l e y (of the U n i v e r s i t y College, Cardiff), P r o f e s s o r G. B r own (of P r i n c e t o n ) , and P r o f e s s o r M. B u e r g e r (o f H . I . T , ). T h e s e e x a m i n a t i o n s i n c l u d e d X - r a y d i f f r a c tion analysis, differential thermal analysis, and transmission electron microscopy. D u ring the period December 1972 to October 1973, 93 lots were indi vidually sampled and examined by X-ray diffractometry for the presence of asbestos minerals. No amphiboles or serpentine minerals were detected in any sample. FISH BAINWCD-00000006 */ Dr. N. F. E s trin C.T.F.A. - 2- U a r c h 15, 1 9 7 6 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 examination of sequential lots, A further 100 lots have since been examined, applying both metho d s to each sample. Again, no amp h l b o l e o r se r pentine minerals have been detected. I would like to advise that we are continuing to employ differential thermal analysis and X - ray d i f f r actometry in the e x a mination of sequential lots for the detection of amphibole and serpentine mi n erals. It should be pointed out that we also maintain a w o r ldwide m o n i t o r i n g of talcs used by our Johnson & Johnson affiliates, employing these same techniques. Finally, let me add that periodically, we also submit sub-samples for Transmission Electron Microscope examination and these have always verified the absence of asbestiform minerals. It is our understan d i n g that you would w i s h to submit this information to the FDA. Please regard this letter as non-confideatisi. Sincerely yours, ( . George Dee Director of Applied Research GL/mm ABY PRODUCTS COMPANY jjofwiDiioiJufiinon N EW BR U N SW IC K. N J. OSSOS M a r c h 14, 1976 EXAMINATION OF AMERICAN & BRITISH TALCUM POWDER ___________ P R O D U C T S B Y DR, F. D, P O O L E V _____________ A t o t a l o f .38 s a m p l e s o r i g i n a t i n g f r o m t h e l a b o r a t o r y o f t h e Department of Environmental Health, Ut. Sinai Hospital were e x a m i n e d by Dr. F. D. P o o l e y in an e f f o r t to s u b s t a n t i a t e r e s u l t s reported by staff of the Mt. Sinai Hospital. American Talcum Products A total of 20 samples (corresponding to 19 American products) were subjected to examination by X-ray and electron microscope. Dr. Poo l e y verified that five products contained several percent, by weight, of fibrous anthophyllite asbestos. T his is in cont r a s t to the Mt. Sinai report that five of the products c o n t a i n e d 8 t o 20% a s b e s t o s a n d t h a t a n o t h e r f i v e o f t h e p r o d u c t s contained less than 5% asbestos. British Talcum Products Similarly, 18 products w ere examined by Dr. Pooley. He verified one product as containing anthophyllite. On the o t h e r hand, the Mt. Sinai laboratory reported f i n d i n g t r e m o l i t e in three products and anthophyllite in a fourth product. They further reported that tre m o l i t e or an t h o p h y l l i t e w e r e " I n d i c a t e d at or near the lower limit o f d e t e c t a b i l i t y " in five o t her samples. It w a s a l s o r e p o r t e d that "serpentine pha s e w a s found in two, and p o s s i b l y in several other samples," but "electron microscopic examination would be required to resolve the possiblity of the existence of chrysotile". However, Dr. Pooley's subsequent examination with the transmission electron microscope has refuted the existence of any chrysotile. It should be emphasized that these American products were sampled in 1973 and arc not necessarily representative of current American talcum production. FISH BAINWCD-00000007 > w aiter c. me crone associates, inc. C O N S U L T S . ULTflAMICRQANALYSIS M ICROSCOPY SMALL PARTICLE PROBLEM S SOUO-STATC CHEMISTRY 12 M a r c h 1976 D r . N o r m a n Estrln Cosmetics Toiletries and Fragrances Association 1133 15th Street, N . W , Washington, D.C. 20005 D e a r ftr.Eatrto: This letter will amplify our recent conversation on talc analyses for asbestos. Since 1971, Walter C. M c C r o n e Associates, Inc., has worked with several producers and users of talc, the majority of them involved with cosmetic grades of talc. During this period w e have analyzed several hundred talc samples for the presence of asbestiform minerals. The methodologies used have been principally X- r a y diffraction and light microscopy using dispersion staining, although extensive transmission electron microscopy examinations have been carried out for s o m e companies. Subject to the approval of our clients, w e are prepared to m a k e available to the F D A .through C TFA.the results of these analyses. W e also have available retained samples for mo s t of the analyses. Verbal agreement to release this data has been already given by clients accounting for probably SQ-90% of the samples; the others have not yet been approached. It would, however, be improper for us to c o m m e n t on specific samples until such time as written approval is received from our clients, together with identification of those materials used in cosmetic production. T h e latter point is stressed because several of our anafyses represent the results of raw material assessments which s o m e companies initiated and 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 1 w e r e to c o m m e n t on the asbestos in talc situation as w o s a w It over the last 5 years. I think our view can be s u m m a r i z e d quite briefly as follows. M t o SOUTH M ICHIGAN AVENUE CHICAGO. ILLINOIS 60516 - 3 12/64J-7100 - C A K E CHEMlCRONE f* U M a r c h 1976 D f N o r m a n Estrln Cosmetics Toiletries and Fragrances Association Pag T w o S o m e cosmetic talcs prior to about mid-1972 to early 1973 w e r e found to contain amphiboles -- principally of the Tremotite-Anthophyllite lype at levels, determined by X- r a y diffraction, of the order of 5-15% by weight. Microscopical examination of these' talcs, however, Indicated that the bulk of this amphibole content (>90%) w a s non-fibrous, even applying the 3:1 aspect ratio criterion for a fiber, and hence not asbestos. N o chrysotlle asbestos wa s found in these taka. Since 1973 none of the talcs which w e hare examined and which bare been identified to us as production materials have s h o w n any detectable levels of either chrysotlle or asbestlform amphibole. Yours sincerely, lan M . Stewart Manager* Electron Optics Group Companies contacted and granting verbal approval to release information include : Avon Products, Inc. Bristol-Myers Products Chesetrough-Ponds, Inc. Colgate-Palmolive, Inc. Faberge, Inc Johnson G Johnson Windsor Minerais, Inc. Whittaker, Clark G Daniels, Inc. F ISH B A IN W C D -00000008 S v a t L J Q D l i liiftftl, 9<3 P A R K A V E N U E . N E W Y O R K . N Y . 1 0 0 1 9 executive ornes March 12, 1976 C orporat< D irector o f Quality M U COOC Ut c m U- innoMit m i Mit D r . Korin an E s t r i n Vice President - Science The Cosmetic, Toiletry & Fragrance 1133 Fifteenth Street N.W, Washington, D.C. 20005 Association, Inc. Dear Borman: Sterling Drug Inc. initiated testing in November 1971 of the talc used in "ZBT Baby Powder" for the presence of a"beftti f o r m m i n e r a l s . S i n c e t h a t t i m e w e h a v e h a d t e s t e d by x-ray diffraction analysis about one-third of the lots received. In all instances the results indicated there was no detectable asbestiform minerals present in these samples: We also have had assurance from our supplier, Whittaker, Clark & Daniels, Inc., that they routinely monitor the shipments of talc supplied us for the presence of asbestiform minerals and have found no detectable amounts. We are willing to meet with FDA at some future date to present the detailed results of this testing. As I told you the code on the p a c k a g e o f "Z B T Ba b y Powder" tested by the Mount Sinai Hospital group was coded and was produced in June 1970. We are of the opinion that the testing we and our suppliers have performed assures us that the "ZBT Baby Powder" produced since late 1971 does not contain asbestiform minerals. Sincerely, RAM:mm ; Roderick A. Mundy - ft r-:.' -<f- : V ' CABLE -ILEINAD' i i t O l l M l 4 1 DO 'lO O O COOL1DOE ETN EET * SOUTH P LA IN F IE LD . n j 0 7 0 8 0 M a r c h it, 176 Or. N o r m a n Estrin C T F A Headquarters 1t33 Fifteenth S t r e e t , N . W . Washington, D.C. 20005 D e a r Dr. Estrin: 1171 In A u g u s t / a test p r o g r a m w a s instituted by o u r c o m p a n y to insure c u s t o m r s using o u r c o s m e t i c g r a d e talcs that they a r e Free of fibrous as bestos . It w a s d e t e r m i n e d that the u s e of X - r a y diffraction w o u l d be the m o s t practical m e t h o d of detecting the possible p r e s e n c e of asbestos a n d thus a s s u r e u s of a reliable a n d w o r k a b l e m e a n s of periodic m o n i t o r i n g o u r talcs. In the event that the results of this testing s h o w e d possible positive results, the s a m p l e w a s further subjected to optical m i c r o s c o p y . In all cases the testing of our products w a s p e r f o r m e d by outside independent laboratories. W e h a v e also u s e d other test m e t h o d s s u c h as Differential T h e r m a l Analysis an d Optical M i c r o s c o p y , h o w e v e r X - r a y diffraction g a v e us the best reproducable results. O u r file contains reports o n various g r a d e s of c o s m e t i c talc f r o m a r e a s in A l a b a m a , N o r t h Carolina, M o n t a n a , Italy, South K o r e a a n d V e r m o n t . T h e s e reports w e r e based on approximately 74 ground ore samples a n a l y z e d o v e r a period of four y e a r s all of w h i c h s h o w non-detectable a m o u n t s of fibrous as b e s t o s f o r m m i n e r a l s . Additionally, sep a r a t e tests m a d e during this period b y m a n y of o u r customr-i-s suppcrteci anti substantiated o u r test results. A l l of the testing for the p r e s e n c e of a s bestos f o r m m i n e r a l s In talc ha s b e e n p e r f o r m e d b y "outside experts" including the Following: W a l t e r C , M c C r o n e Ass o c i a t e s , Chicago, Illinois Ernest Fullom Associates, Schenectsdyr, Mow Y o r k E .S . L a b o r a t o r i e s , Mar.lton. N e w J e r s e y Prof* Charles R, Manning, North Carolina University Prof. S e y m o u r Z . Lewin, N e w Y o r k University Dr. G o r d o n B r o w n , Princeton University continued ....... ^ .. . IMPORTERS * M A N lirAC11IHFHS . TM'O RW IINERALS, COLORS. PIG M EN TS FISH BAI NWCD-00000009 / W D e Bell a Richardson, Enfield, Connecticut C o l u m b i a Scientific Industries, Austin, T e x a s W e a r e willing to s u b m i t this information to the c o m m i t t e e In detail to help substantiate their claims. V e r y truly ycrurs, W H I T T A K E R , C L A R K a DANIELS,INC. Frederick F* Roesch Executive Vice President FFR/dm