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FILE NAME Talc TALC DATE 1976 DOC TALC153 DOCUMENT DESCRIPTION Letters & Memos within the Cosmetic Companies and CTFA WINKELTRSCP0218Ex 6587-1 : The Cosmetic Toiletry and Fragrance Association Inc. ve 1133 156 STREET N.W. WASHINGTON DC 2000 + 331-+ 1 TEL7 EX 7 85-20 673 James H. Merrut . . F Norman Estrin Ph.D. HaeEstrinPh.D. March 15th 1976 Mr. Heinz J. Eiermann . Food and Drug Administration 200 C Street S.W. Washington D.C. 20204 On March 11th 1976 Mr. Eiermann -~ the CTFA current tus Talc Subcommittee met to discuss the sta- tus of tale It was recognized that a need exists to bring to your attention a profile of the analyses for asbestos form materials in tale used in the U.S. production of cosmetics and toiletry products Individual companies are more than willing to discuss the detailed data with you at your convenience Cordially - Norman F. Estrin Ph.D. Vice President - Science HEE Attachments iN) The Cosmetic Toiletry and Fragrance Association Inc. MEMORANDUM PresEestrnia t- TO Norman F. Estrin Ph.D. FROM Anita S. Curry a DATE March 12th 1975 Jim Jenkins called regarding the letter you have asked for AR GUP rent talc analyses He wishes to inform you as to what they have been doing 1. Mr. Clements contacted Dr. Langer who gave him the code on the Coty Airspun that was tested It turns out that this was a July tion item 1969 produc- . 2 In 1970 Coty changed to a completely different talc since that time the supplier WC has supplied letters to the effect that they do 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 at the Pfizer Laboratory in Easton Pennsylvania These were done by 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 ASC ij ~s r2 tas te mer Sece poans et WINKELTRSCP0219Ex 6587-2 AVON PRODUCTS INC SUFFERN . YORK --0901 March 12 1976 Dr. Norman Estrin CTFA 1133 15th Street N.W. Washington D.C. 20005 Dear Norm This is to confirm our to you and the Food of all lots of talc we indication yesterday of our willingness to disclose and Drug Administration the results of our analyses have used in our products during the past three years we During 1973 all of our tale receipts were sampled and aliquots were sent to McCrone Associates for 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 earlier data indicated that they were present only rarely in the talcs examined A total of 170 samples of tales used in our products were examined by McCrone during that year The ray diffraction patterns are on file at McCrone and reviewed by authorized people The results were negative can be Since February house by DTA we felt that IR of the rareness made available receipts 1974 we have analyzed about 250 samples of talc for chrysotile and IR for tremolite As mentioned for tremolite was adequate for screening purposes of other amphiboles The data from these analyses also if needed The results were negative above because can be Please let us know asbestos if there is anything else we can do to help resolve the of in talc JJT CC _ C. S. Rowland G. A. Sprott R. C. Reardon Central File Yours truly ---- ---- -- --,--, ---- ---- ------,----, ---- -- J. Travers --,--, . 13 at * . - ra a Chesebrough Inc. RESEARCH LABORATORIES TAUMBULL INDUSTRIAL PARK TRUMBULL CONNECTICUT 06411 PHONE acd 377-7100 March 12 1976 Dr. Norman Estrin Cosmetic Toiletry & Fragrance 1133 - 15th Street N.W. Washington D.C. 20005 - Association Dear Norman For some years Chesebrough Ine has been concerned about reports that some tales might contain asbestos as a occurring contaminant As you know we 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 tale 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 talcs of three types from three different in the attachment to monitor incoming that we have been using These three geographical areas cosmetic are I have reviewed the results of these analyses on the incoming lots of these tales used in recent production of cosmetic and toiletry products in the United States The last 84 reports covering a three period are without exception negative for chrysotile and negative for fibrous amphiboles If it can be useful we would be pleased to discuss these data with scientists at the Food and Drug Administration bm encl Sincerely = may Beroinet Beroinet may Murray Berdick Beroinet Beroinet Beroinet Beroinet Director of Regulatory Affairs + and 004 3.65 -0.03A 1/1 - 30- 20 reflections.and showing no line to the 14.GA evidence chlorite region is necessary and sufficient for the presence of chrysotils A line at 14.5A in addition to and of the proper intensity relative the 7.3A and _ 3.65A nes identifies chlorite rather than chrysotile When the ray evidence is equivocal optical crystallography may be used to confirm chrysotile Positive identification will then be based on the known morphological and optical properties of chrysotile The normal form of chrysolile is a parallel bundle of long fibers each a hollow cylinder only about 220A in diameter It is monoclinic with y ranging from 1.545-1.556 1.545-1.556 1.545-1.556 p from 1.539 - 1.559 and a from 1.532-1.550 1.532-1.550 1.532-1.550 The sign of elongation is positive since y lies nearly parallel to the length of the needles The birefringence is about 0.015 hence a 5 m thick bundio will show a retardation of 75 am gray The birefringence of a 2 ...mthick bundle of chrysotile fibers would be barely detectable even with a first order red plate +1 Dispersion staining is a sensitive and specific method for liber n chrysotile In the Cargille high dispersion liquid = 1.550 most chrysotile fiber warebundles show colors in the magenta region with the central stop for the vibration direction parallel to the length and in the blue for vibration directions crosswise Unfortunately in a preparation of quartz particles about 10 will lie in position showing the same two colors for vibration directions 90 apart These can usually be identified as quartz by morphology or by the fact that the sample contains but many other particles of similar morphology showing blue central stop colors in all positions of stage rotation All chrysotile fiber bundles are constrained by shape to showing lying hence always showing both blus crosswise ) and blue parallel to the length for central stop colors ' . + evidence Tremolite - Necessary and sufficient for the presence of tremolite is an ray powder diffraction pattern with lines at 8.4 0.1A 3.27 -0.05A 3.03 -0.05A and 2.92 -0.05A Note zinc and magnesium stearate 23.03A may interfers at 8.4A and calcite When the ray evidence is equivocal optical crystallography may be used to verify the presence of tremolite Positive evidence will then be based on accepted morphological and optical properties of tremolite The common form is monoclinic rods elongated nearly parallel to y about 1.63 but with oblique extinction of 10-21 for crystals lying on the 010 face The optic axial plane is 010 hence a about 1.60 is also shown on the 010 view The view showing 8 about 1.615 and y about 1.63flshows parallel extinction The optic axial angle is about 80 with a negative sign and weak dispersion r Polarization colors are moderate and approximately 100 am gray for a 10 ...mthick rod in all crosswise orientations 200 num yellow for a 30 ...mthick crystal Characteristic dispersion staining colors are observed in Cargille bigh disper- y sion liquid 1.605 about 430 am is to for violet with the annular stop and yellow with the central stop about 490 nm for green annutar stop and golden magenta - atop and about 600 um for orange annular stop and blue central j . WINKELTRSCP02 central ' . . * s *, . o a WINKELTRSCP02 PALMOLIVE COMPANY 909 River Road Piscataway N.J. 08854 Norman F. Estrin Ph.D. Vice President The Cosmetic Toiletry and Fragrance Association Inc. 1133-15th Street N.W. Washington D.C. 20005 March 15 1976 Dear Dr. Estrin Attached please find a summary of Analytical Data on 42 Tale Samples representing 20 raw materials and 17 finished products covering the period 1971 to present and examined by various techniques by the Palmolive Research and Development Analytical Department and McCrone Associates Asbestos minerals were in any insignificant detected amounts these samples the exception of insignificant trace amounts found by micro- scopic in three samples from 1971-1972 which is believed methods due to laboratory absence of any laboratory asbestos contamination Other methodologies indicate the results of these analyses indicate 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 Palmolive's Cashmere Bouquet examined by Dr. Langer of Mt. Sinai Hospital was by Dr. Langer has not War II This company three years ago The Bauer and Black Talc reported been manufactured since the end of World was acquired by Palmolive approximately Very truly yours Excephen Excephen H. Get Get Christopher H. Costello Ph.D. Administrator Regulatory Affairs CEC Attachments March 12 1976 To From Subject Dr. C. H. Costello j P. Simko Jr. Analytical Data on Talc Samples Present first raised asbestos talc was Analytical has been engaged in analyzing U.S. talc raw material and finished products for asbestos minerals by the most sophisticated methodology available at that time Analyses were made on a check basis Techniques used inhouse are ray diffraction followed by optical and scanning electron microscopy if necessary ray is the basic screening tool and examination by microscopy is made when positive responses occur Additional tests on random samples were made by transmission electron microscopy and selected area electron diffraction by an outside consulting firm Forty samples from 20 raw materials and from 17 finished below products covering the period 1971 to the present have been examined by these various techniques Asbestos minerals were not detected in any of these with the exception of trace amounts 3 samples from 1971-2 These levels are considered generally below the normal background levels encountered when this microscopic methodology is employed It is believed that these trace amounts due to are attached laboratory contamination A detailed tabulation is JPS Att No. of Samples Examined for Asbestos Minerals 1972-76 Method SARD Sample dates yrs _ Raw Tale 45 1971-72 Cashmere Bounset ** 1972-76 ray plus microscopy optical SEX Sample dates yrs RTA Sample dates yrs 12 1971-76 $ 1972 21 1972-76 & 1972 1 sample 19 ra7 w t1 ale +1 sample 1971 raw tale contained 10-100 ppm contained 1-10 ppm chrysctile chrysotile These levels re- babcakgcrkogurndoupnodsscionb-le tamination ** sample 1972 Casimere Bouquet tale contained 5 ppm chrysctile No amphibole detected in any of these JPB ed 3-12-76 WINKELTRSCP021Ex a 6587-4 WINKELTRSCP02 WINKELTRSCP02Ex 6587-5 CTFA WSH u USH i, TLXAYAB VAF13901427341-018216A 03/12/76 1424 + TVX CIM123 LSA : , . 20 LOSA CA PIS THE COSMETIC TOILETRY AND FRAGARNCE 1133 FIFTEENTH STREET N. W. AND WASHINGTON D. C. 20005 ASSOCIATION IN MARCH 12 1976 DR NORMAN ESTRIN VICE PRESIDENT - SCIENCE * DEAR DR ESTRIN AS A RESULT OF DISCUSSIONS I HAVE HAD WITH LOUIS NURINO CONCERNING THE MARCH 11 1976 CTFA TALC COMITTEE MEETING I WOULD LIKE TO STATE THAT WE HAVE A CONTINUING PROGRAM IN EXISTENCE TO TEST OUR MONTANA GRADES OF TALCS THAT ARE BEING BEING OFFERED TO THE COSMETIC INDUSTRY PRIOR CORRESPONDENCE BETWEEN OURSELVES AND NR SZORGE V. SANDLAND CHAIRMAN OF THE TALC COMITTEE HAS ESTABLISHED THAT WE HAVE TESTED 2.839 SAMPLES FROM OUR CORE DRILLING PROGRAM AND BY RAY DIFFRACTION PATTERNS HAVE NO SEEN ANY DETECTABLE LEVELS OF CHRYSCHILE AND TREVOLITE DIFFRACTION OUR RAY DIFFRACTION TECHNIQUES ARE IN ACCORDANCE WITH THE CTFA 4-1 METHOD OUTLINED FOR USE UNDER CTFA SPECIFICATIONS FOR COSMETIC TALC SINCE OUR ORIGINAL INVESTIGATION AND SUBMISSION AUGUST 8 1975 WE HAVE EVALUATED AN ADDITIONAL FIFTY HONATAN PRODUCTION SAMPLES WITH THE SAME EXCELLENT RESULTS VE CONTINUE TO USE RAY DIFFRACTION TECHNIQUES AS OUTLINED BY CTFA 4-1 COOPERATE WE SHALL BE HAPPTY TO CONTINUE TO OUR TESTING PROGRAM WITH CIFA IN VERY TRULY YOURS CYPRUS INDUSTRIAL MINERALS COMPANY 555 SOUTH FLOWER STREET LOS ANGELES CALIFORNIA 98871 TELEPHONE / + NNNN 213 . 489-3708 | . H. T. ULAYAN PRESIDENT 323PEST CIFA USH TALC INVESTIGATIONS Our investigations of samples were analyzed asbestos content talc dates by McCrone back to November 1972 when the Associates and found to be free . : following of any Music Talc Aphrodisia Women's Talo Aphrodisia Man's Tale Flambeau Tale Woodhue Men's Tala Straw Hat Tale Tigress Talc Brut Tale Kiku Talc Woodhue Women's Talc Xanadu Tale . Zizania Tale 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 9-26-72 .9-2672 .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 McCrone Associates and found to be free of any asbestos contant Brut Tale Brut Talc Kiku Tale Kiku Talc Kiku Tale Xanadu Talc 3.4.75 20.6.75 11.11.75 24.4.75 3.7.75 20.6.75 On March 9 1976 McCrone Assoc purchased in a Chicago of Brut Tale Lot 2585 which was produced on September VAS also found to be free of any asbestos concent store one 15 1975 4 oz container This sample FABERGE DIVISION IS RAILROAD AVENUE RIDGEFIELD NEW JERSEY 07657 201 945-5800 . : +. SANY PRODUCTS COMPANY Johmon Johnson NEW BRUNSWICK N. 06903 March 15 1976 Dr. N. F. Estrin , C.T.F.A. -2- : - 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 & Johnson is solely derived from its own mine in Vermont where the ore is mined selectively and then beneficiated by the process of flotation Shipments of this highly purified talc are routinely examined by , our own laboratory to verify the absence of asbestos minerals : Historically Johnson & Johnson has always been concerned about the mineralogical integrity of its talcs and even its earliest speci- . fications have required the examination for acicular particulates When it was erroneously reported in 1971 that our powder contained asbestos we sponsored a scientific seminar of mineralogical and analytical experts for the FDA to prove that our talc is not con- taminated with asbestos At that time numerous samples were analyzed by experienced consultants such as McCrone Associates Colorado School of Wines Professor F. D. Pooley of the University College Cardiff Professor G. Brown of Princeton and Professor M. Buerger of M.I.T. These examinations included ray diffrac . tion analysis differential thermal analysis and transmission electron microscopy During the period December 1972 to October 1973 93 lots were indi- vidually sampled and examined by ray diffractometry for the presence of asbestos minerals No amphiboles or serpentine minerals were detected in any sample Beginning in October 1973 differential thermal analysis was added to our specified requirement Both differential thermal analysis and ray diffractometry were instituted for the routine examination of sequential lots A further 100 lots have since been examined applying both methods to each sample pentine minerals have been detected Again no amphibole or ser- I would like to advise that we are continuing to employ differential thermal analysis and ray diffractometry in the examination of sequential lots for the detection of amphibole and serpentine minerals It should be pointed of talcs used by our same techniques out that we also maintain a worldwide monitoring Johnson & Johnson affiliates employing these Finally let me add that periodically we also submit samples for Transmission Electron Microscope examination and these have ? always verified the absence of asbestiform minerals It is our understanding that you would wish to submit this information , to the FDA Please regard this letter as confidential Sincerely yours LM George Lee Director of Applied Research KM vy WINKELTRSCP023Ex 6587-6 WINKELTRSCP024 WINKELTRSCP024 Ex 6587- Johnson Johnson NEW BRUNSWICK NJ NJ 08903 March 14 1976 EXAMINATION OF AMERICAN & BRITISH TALCUM POWDER PRODUCTS BY DR F. D. POOLEY A total of 38 samples originating from the laboratory of the Department of Environmental Health Mt. Sinai Hospital were ex- amined by Dr. F. D. Pooley in an effort to substantiate results 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 ray and electron microscope Dr. Pooley verified that five products contained several percent by weight of fibrous anthophyllite asbestos This is in contrast to the Mt. Sinai contained 8 to 20 asbestos and that contained less than % asbestos report that five of another five of the the products products British Talcum Products Similarly 18 products were examined by Dr. Pooley He verified one product as containing anthophyllite On the other hand the Mt. Sinai laboratory reported finding tremolite in three products and anthophyllite in a fourth product They further reported that tre- molite or anthophyllite were indicated at or near the lower limit of detectability in five other samples It was also reported that serpentine phase was found in two and possibly 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 in 1973 and are not talcum production that these American products were necessarily representative representative of current . sampled American Ay ih walter c.mccrone c.mccrone associates inc CONSULTING ULTRAMCROANALYSIS + MICROSCOPY SMALL PARTICLE PROBLEMS STATE CHEMISTRY 12 March 1976 Dr. Norman Estrin Cosmetics Cosmetics Toiletries and Fragrances 1133 15th Street N.W. Washington D.C. 20005 As ociation . Dear Dr. Eatrin This letter will amplify our recent conversation on talo analyses for asbestos Since 1971 Walter C. McCrone Associates Inc. has worked with several producers and users of talc the of them with grades of tale During this period we have analyzed several hundred talc samples for the presence of asbestiform minerals The methodologies used been principally have staining although ray diffraction and light microscopy using dispersion have been carried out for some companies Subject to the approval of our clients we are prepared to make available to the FDA through CTFA results of these analyses We also have available retained samples for most of the analyses Verbal agreement to release this data has been already given by clients accounting for probably 80-90 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 clients together with identification of those materials used in our cosmetic The latter point is stressed because several of production the initiated results of raw material assessments which some companies and might include tale ore bodies which are unacceptable for cosmetic applica- tions violating that would be do notthink however I were to on the situation in tale any confidences if as we saw it over the ye5ayr eas rs I think our view can be summarized quite briefly as follows - 2820 SOUTH MICHIGAN AVENUE CHICAGO ILLINOIS 0816 + 842-7180CALE 842-7180CALE 842-7180CALE CHEMICRONE WINKELTRSCP025 WINKELTRSCPT0 0 2025 WINKELTRSCP025Ex 6587-8 13 March 1976 Dr. Norman Estrin Cosmetics Toiletries and Fragrances Association Page Two Anthophyllite Some cosmetic tales prior to about 1972 to early 1973 were found contain amphiboles principally of the to levels determined by ray diffraction of the order of 5-15 bytywpeeiagtht . Microscopical examination of these tales of this however indicated that the bulk amphibole content 90 was fibrous even applying the 3 asbestos aspect ratio criterion for a fiber and hence not No chrysotile asbestos was found in these tales any levels Since 1973 none of the talcs which we have examined and identified to us as production materials have shown which have been detectable of either chrysotile or asbestiform amphibole ' Yours sincerely Jan Stewart Ian M. Stewart Manager Electron Optics Group Companiincluede s contacted and granting verbal approval to release information Avon Products Inc. Bristol Products Chesebrough Inc. Palmolive Inc. Faberge Inc. Johnson & Johnson Windsor Minerals Inc. Whittaker Clark & Daniels Inc. . Ima STERLING STERLING STERLING DRUG INC GO PARK AVENUE NEW YORK 10016 EXECUTIVE OFFICES March 12 1976 Corporate Director of Quality AREA CODE 214 72.44721 .441 ATA one CABLE Team 30 Dr. Norman Estrin Vice President - Science The Cosmetic Toiletry & Fragrance 1133 Pifteenth Street Street N.W. Washington D.C. 20005 Association Inc. Dear Norman of Sterling Drug Inc. initiated testing in November November 1971 the talc used in ZBT Baby Powder for the presence asbestiform minerals . presence of Since that time we have had had tested by ray diffraction analysis about third of the lots received In all instances the results indicated there was no detectable asbestiform minerals present in in these samples We also have had assurance from our supplier Whittaker Clark & Daniels Daniels Inc. that they supplier routinely monitor the shipments of talc supplied us for the the of asbestiform minerals minerals and have found presence no detectable amounts testing We are willing to meet with FDA at some to present the detailed detailed results of this future date As I told you the code on the of ZBT package Powder tested by thethe Mount Sinai Hospital Baby and was produced in June 1970. We group was coded 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 contain asbestiform minerals Sincerely Py : bse ee + HfpS kPa. Roderick A. Mundy vt, WINKELTRSCP026Ex 6587-9 2011 .4100 WHITTAKER WHIT AKER WHITTAKER DANIELS 1000 COOLIDGE STREET " SOUTH PLAINFIELD NJ 07680 March 11 1978 + Dr. Norman Estrin CTFA Headquarters . 1133 Fifteenth Street Washington D.C. 20005 * Dear Dr. Estrin . 1371 In August test program was instituted by our company to insure customers using our cosmetic grade talcs that they are free of fibrous asbestos . It was determined that the use of ray diffraction would be the most practical method of detecting the possible presence of asbestos and thus assure us of a reliable and workable means of periodic monitoring our tales In the event that the results of this subjected testing showed possible positive results the sample was further to optical microscopy In all cases the testing of our products was performed by outside independent laboratories We have also used other test methods such as Differential Thermal Analysis and Optical Microscopy however ray diffraction gave us the best reproducable results Our file contains reports on various grades of cosmetic talc from areas in Alabama North Carolina Montana Italy South Korea and Vermont These reports were based on approximately 74 ground ore samples analyzed over a period of four years all of which show detectable amounts of fibrous asbestos form minerals Additionally separate tests made during this period by many of our customers supported and substantiated our test results All of the testing for the presence of asbestos form minerals in talc has been performed by outside experts including the following Walter C. McCrone Associates Chicago Illinois Ernest Fullom Associates Schenectadyr Schenectadyr New York E.S. Laboratories Marlton New Jersey Prof. Charles R. Manning North Carolina University Prof. Seymour Z. Lewin New York University Dr. Gordon Brown Princeton University wv ee continued IMPORTERS ' MANUFACTURERS + EXPORTIN EXPORTIN MINERALS COLORS PIGMENTS ry a -en De Bell & Richardson Enfield Connecticut Columbia Scientific Industries Austin Texas We are willing to submit this information to the committee in detail to help substantiate their claims Very truly yours WHITTAKER CLARK & DANIELS INC Frederick F. Roesch Executive Vice President