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FILE NAME Talc TALC DATE 1971 DOC TALC149 DOCUMENT DESCRIPTION Memorandum of a Symposium Asbestos and Talc Aug 3 1971 with Cover Letter from the FDA i, a ed ~ DEPARTMENT OF HEALTH FDUCATION AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION WASHINGTON DC 20204 Catch^r_6 Catch^r_6 1971 To Participsats in Asbestos and Talc Discussion Session at FDA on August 3 1971 Attached : in a summary of our recent Discussion many of you know I have proceduzca from all ofof At work this writing proceed with the LynthesisLynthesis of circulatedcirculated for comments these into into a are package package package package package package package con Thank you once again for your assistance and pasticipation Sincerely yours Wester Alfred Wester Wester Alfred Alfred Wester Wester Alfred Alfred Wester Wester Wester Wester Product TechnologyTechnologyTechnology Technology CPC2-00000001 MEMORANDUM OF A SYMPOSIUM August 3 1971 ASBESTOS AND TALC Held at the Food and Drug Administration 200 C Street S.W. Washington D.C. 20204 Moderator Dr. Alfred Weissler Director Division of Colors & Cosmetics Technology SUMMARY The amount of asbestos fibers in talcum powder health hazards associated with their presence interest but differing reports products and the inhalation are subjects of current At a symposium held on August 3 at the Food and Drug Administration attende by over 40 scientists physicians and consumers it was generally agreed manufacturers that most talcum powders of major asbestos are Nevertheless on behalf of consumers FDA is working laboratory procedure for the analysis of asbestos in will give consistent meaningful resulta on the talcum details powders of a which Accurate analyses for the amount of asbestos in talcum powder will be obtainable according to many of the participants only through the use of a battery of specialized instruments and techniques including ray diffrac tion polarizing optical microscopy electron microscopanyd electron _ diffraction of selected particles In addition to extensive discussions of the analytical methods for asbestos used by various laboratories the group also considered such topics as the medical significance of asbestos and other fibers and the mineralogy of asbestos and tald ore deposits INTRODUCTION Dr. Weissler opened the meeting by outlining some of the events which had brought the question of asbestos particles in tale to the attention of FDA He indicated that in response to a letter from Jerome Kretchmer Administrat Environmental Protection Agency New York City to HEW Secretary Richardson on June 28 1971 the FDA was tos particles in talc taking steps to investigate the problem of asbe CPC2-00000002 As a first step the FDA would like to establish a laboratory procedure for the determination of asbestos in talcum powder products that will give meaningful and consistent results Once the methodology is agreed upon FDA would be in a position to determine if such products on the market contain asbestos fibers The format of the meeting consisted of short presentations by each participant followed by informal discussions which served to pool the knowledge of the experts present A list of the discussion topics is attached GENERAL DISCUSSION 1 Dr. Ross of the U.S. Geological Survey made the first presentation Dr. Ross a minerologist outlined the various associations of asbestos mineral species with talc During this presentation and the discussion which ensued the following salient points emerged a Definition Asbestos is a generic term for a variety of hydrated silicate minerals which have one common attribute the ability to be separated into relatively soft silky fibers Although the name is ordinarily associated with those varieties which have technologic importance it is applicable to all minerals which fit the above descriptions The term asbestoform minerals is perhaps most descripti1 ve b The known varieties of asbestoform minerals can be divided into two main classes on the basis of their crystal structures serpentine and amphiboles The sole member of the serpentine class is chrysotile asbestos which is by far the most common of the asbestoform minerals It accounts for more than 95 of the asbestos fiber produced today There are five recognized asbestoform varieties of amphibole crocidolite amosite anthophyllite tremolitaned actinolite Although the amphiboles are common rock forming minerals the asbestoform varieties are much less abundant than chrysotile 1 c The empirical formula of talc and some asbestoform minerals can be represented as follows . Talc Mg3 Si4 010 OH Serpentine Class Chrysotile Mg3 Si2 05 OH 1 Speil S. and Leineweber J.P. Environmental Research 2 166-208 1969 CPC2-00000003 Amphibole Class Page 3 Anthophyllite Mg Fe Sig 022 OH 2 Tremolite Ca2 Mgs Sig 022 OH Actinolite Caq Mg Fe Sig 022 OH d It is not unusual to find large variations in the composition of a mineral within a relatively small area of a given deposit The differences depend to a great extent on the mineralogy involved 2. Dr. Cralley of the National Institute for Occupational Safety and Health spoke on the fibrous content of cosmetic talcum products Hia . presentation centered in part on a paper he authored entitled Fibrous and Mineral Content of Cosmetic dustrial Hygiene Association Journal 29 conclusions were made in this paper Talcum Products Amer In350-4 1968 The following With the exception of 4 of the 22 cosmetic talcum products analyzed the levels of free silica cobalt nickel chromium and manganese were generally of a low magnitude and within a narrow range It is not known whether the four products represent a significant proportion of sales in the industry or to what extent the sources of the talc in these four form- lations are the same as sources of talc specified for use in other talcum products in the competitive market in these to be of The levels of silica chromium and nickel four products are sufficiently high however concern in their potential to cause disease All of the 22 talcum products analyzed have an appreciable fiber content ranging from 8 to 30 by count of the total talcum particulates and averaging 19 The fibrous material was predominantly talc but probably contained minor amounts of tremolite anthophyIlite and chrysotile as these are often present in fibrous talc mineral deposits Cosmetic talcum products should be included as a source of the fibers from which may be derived ferruginous bodies observed in the lungs of humans The meaning of the presence of these ferruginous bodies however is uncertain 3. The third discussion topic on the program dealt medical significance of asbestos and other fibers themselvetso this topic . with the biological and Three speakers addresse a Dr. Selikoff of Mount Sinai School of Medicine outlined briefly the history fibrosis in asbestos workers which has been known to when officials the medical years ago profession for over 30 he met with FDA years He reported that a few there was no apparent CPC2-00000004 Page 4 problem presented to the general population with regard to asbestos It was considered at that time to be mainly an occupational problem He reported that recently acquired knowledge has greatly increased his concern over the whole question of asbestos fibers the environment He felt that the new dimension added to the problem was the possibility that lung cancer may result even from exposures at less than occupation levels b Dr. Hildick Director of Clinical Research for Johnson and Johnson & outlined briefly the medical aspects of talc production and uses He reported that & has been in the talc business for over 70 years Talc along with a whole host of other materials can give rise to a biological response & has not noted any adverse effects from the use of talc in either their employees or reported in the literature Tole manufactured by J is highly refined to produce a platy talc Available data indicates that there is no health hazard associated with the use of cosmetic grade talc It was aiso pointed out that talc introduced surgically does not apparently cause mesotheliomas c Dr. Gross of the Medical University of South Carolina reported that there is very little if any data on the effects of talc in man or animal Intratracheal injection of talc in hamsters caused no ill effects In these animals no lung scarring was seen Asbestos particles do not cause lung damage less than 5 microns in length This point however has not reportedly ' been definitely confirmed 4. Dr. Kraybill of FDA's Bureau of Foods reported that the subject of asbestos in food and the environment had been evaluated within the past few years and that no need for regulatory action was indicated Recent events however may require that the problem be restudied Dr. Barzilai of the Bureau of Drugs reported that particulate matter in drug products are under study and that he would be very interested in learning about the analytical methodology which can be used for the identification of small particles 5. Morris Kaplan of Consumers Union indicated that we always seem to be looking at problems after they occur rather than anticipating them He hoped that existing knowledge on the subject of asbestos and talc would be resolved in the interest of the consumer rather than in the interest of the producer CPC2-00000005 Page 5 6. Dr. Estrin of the Cosmetics Toiletry and Fragrance that the Association was ready to join with FDA and the to determine if there is a consumer safety problem with Association reported academic community talc ANALYTICAL METHODOLOGY The afternoon session was devoted to a discussion of analytical methods that could be used for the identification and determination of asbestos in talc Six presentations were given outlining methods used in various laboratories 1 Mr. Eisenberg of the Division of Microbiology reported on optical methods such as the use of the polarizing microscope for the detection of asbestoform minerals in tale 3 Dr. Levin a consultant for Whittaker Clark and Daniels reported that ray powder diffraction woulbde an ideal screening techniqu for rapidly determining which samples of talc contain asbestos minerals He indicated that there are talcs on the market which appear to be objectionable 4. Dr. Langer and Dr. Maggiore of Mount Sinal reported that they use the following techniques to detect and determine asbestoform miner als light microscopy ray powder diffraction electron microsco electron microprobe and electron diffraction During the discussi that followed Dr. Langer's presentation he was asked if he had analyzed a sample referred to as 344 from Johnson and Johnson He said that he had and that it was a high quality talc He added that all the talc producers represented at the meeting pro- duced a high quality talc product' . 5 Dr. Norwood of Charles Pfizer and Company agreed that ray diffra tion woulbde the method of choice for the analysis of asbestos in talc He indicated that by using step scanning and other sophisti techniques you could probably detect down to 0.1 of chrysotile ir talc 6. Dr. Nashed of Johnson and Johnson introduced Dr. Rolle who made available a table which outlined Methods of Analysis of Fibers in Talc Copy attached Dr. Rolle recommended that optical microscopy be used as a first step in detecting fibers in tale If very few or no fibers are seen electron microscopy with elect diffraction should be used If many fibers are seen ray diffract should be used CPC2-00000006 Page 6 7. In closing the meeting Dr. Weissler thanked the participants and summarized the most promising approaches which might be used to determine the presence of asbestos in talc Detailed procedures on analytical methodology be sent to FDA by some of the participants at the meeting and these will be synthesized by FDA and circulated for comments nig nnigig nig John John a Assistant Chief Cosmetics Branch Division of Colors & Cosmetics Technology The following people attended the symposium Lewis J. Cralley Ph.D. National Institute of Occupational Safety and Health Cincinnati Ohi Irving J. Selikoff M.D. Arthur M. Langer Ph.D. William J. Nicholson Ph.D. C. J. Maggiore Ph.D. Sinai School of Medicine " " It Malcolm Ross Ph.D. U. S. Geological Survey Wilson Nashed Ph.D. Gavin Hildick R. F. Rolle Ph.D. T. H. Shelley Ph.D. A. Goudie Ph.D. M.D. G. R. Grieger Ph.D. Consultant Dr. Norwood Harold D. Stanley Jr. Ph.D. Commr Harold Romer S. R. Mountsier Jr. Prof. S.Z. Lewin Consultant Paul Gross M.D. Sidney Speil Ph.D. Morris Kaplan Norman Estrin Ph.D. Murray Berdick Ph.D. . Charles Pfizer & Company " N.Y.C. Dept. of Air Resources Whittaker Clark & Daniels " Medical University of South Carol Manville Consumers Union Cosmetic Toiletry & Fragrance As $ - CPC2-00000007 Herman F. Kraybill Ph.D. Robert M. Schaffner Ph.D. Alfred Weissler Ph.D. John M. Gowdy M.D. Sylvan H. Newburger Ph.D. John A. Wenninger Charles J. Kokoski Ph.D. George Thompson Ph.D. Dennis J. McGrath M.D. J. W. Cook Byman R. Gittes William V. Barzilai M.D. Jule K. Lamar M.D. Mrs. Manjeet Singh Armand R. Casola Ph.D. M. A. Weinberger M.D. Paul E. Corneliussen K. S. Heine Albert C. Kolbye M.D. " Page 7 Food and Drug Administration 11 t . It 19 " 1 " 11 " = = = = = . = CPC2-00000008 METHOD tical . croscopy anning ectron croscopy ectron roscopy FIBER QUAL ANALYSIS QUANT Yes Presence and Kind of Fiber Yes Point Point and Area Count MINIMUM PARTICLE SIZE DETECTABLE ~ 0.5...m Presence of Fiber Yes Point and Area Count ~ 0.14 Yes Presence and Kind of Fiber Yes Point and Area Count ~ 0.01... LOWER LIMIT OF DETECTABILITY Not Applicable Not Applicable Not Applicable lay fraction Kind of Fiber Yes + wt. Minimum Particle Size for Diffraction is ca. 0.1... 0.1... ~ 0.5 # More Favorable Cases From R. F. Rolle Ph.D. Johnson and Johnson Research Division New Brunswick N.J. 08903 TIME FOR QUANTITATI ANALYSIS 1/2 Day One Day One Day Two Hours to a Day Depending on Metho CPC2-00000009 DIVISION OF COLORS AND COSMETICS TECHNOLOGY FOOD AND DRUG ADMINISTRATION WASHINGTON D.C. ASBESTOS AND TALC Discussion Session August 3 1971 Room 1409 200 C Street Moderator Dr. Alfred Weissler S.W. Discussion Topics 1. Asbestos and Talc Mineral Deposits - Dr. Malcolm Ross U.S. Geological Survey , 2 Fibrous Content of Cosmetic Talcum Products - Dr. L. J. Cralley NIOSH Biological Significance of Asbestos and Other Fibers - Dr. I. J. Selikoff Mt. Sinai School of Medi | Dr. G. Hildick Johnson & Johnson Dr. Paul Gross Medical University of S.C. Current FDA Interests in Asbestos - Dr. R. E. Barzilai Bureau of Drugs Dr. J. K. Lamar Bureau of Drugs Dr. H. F. Kraybill Bureau of Foods Consumer Interest in Asbestos - Morris Kaplan Consumers Union Cosmetics Industry Interest in Asbestos - Dr. Norman Estrin CTFA - 6 Analytical Methods for Asbestos - William Eisenberg FDA Dr. S. Speil Johns Manville S. R. Mountsier Jr. Whittaker Clark & Dr. A. M. Langer Mt. Sinai Dr. Norwood Chas Pfizer & Company Dr. W. Nashed et al Johnson & Johnson CPC2-00000010