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FILE NAME Pfizer PFIZ DATE 1971 Aug 3 DOC PFIZ101 DOCUMENT DESCRIPTION Memorandum of an FDA Symposium - Asbestos and Talc MEMORANDUM OF A SYMPOSIUM. August 3 1971 1971 ASBESTOS AND TALC PLAINTIFF'S EXHIBIT JNJ 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 & symposium held on August 3 at the Food and Drug Administration attended by over 40 scientists physicians and consumers it was generally agreed _ that most talcum powders of major manufacturers are relatively free of asbestos Nevertheless on behalf of consumers FDA is working laboratory procedure for the analysis of asbestos in will give consistent meaningful results 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 microscopy and 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 fibers medical significance of asbestos and other asbestos and talc ore deposits and the mineralogy of 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 Administrator Environmental Protection Agency New York City to HEW Secretary Richardson particles on June 28 1971 the FDA was taking steps to investigate investigate the problem of asbes- tos in talc JNJNL61_000001139 JNJNL61_000001139 JNJNL61_000001139 sSge 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 products upon FDA would be in a position to determine if such contain asbestos fibers on the market The format of the meeting consisted of short presentations by each partici- pant 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 tale During this presentation and the discussion which ensued the following salient points emerged 8 Definition Asbestos is a generic term for a variety of hydrated silicate minerale 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 descriptive 1 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 tremolite and actinolite Although the amphiboles are common 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 OH Tale Mg3 Si4 010 Serpentine Class Chrysotile Mg3 S12 05 OH 1 Speil S. and Leineweber J.P. Environmental Research 2 166-208 1969 JNJNI 000001140 Page 3 Amphibole Class Anthophyllite Mg Fe Sig 022 OH 2 Tremolite Ca2 Mg5 Sig 022 OH x Actinolite Ca2 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 Institut foer Occupational Safety and Health spoke on the fibrous content of cosmetic talcum products His presentation centered in part on a paper he authored entitled Fibrous and Mineral Content of Cosmetic Talcum Products Amer In- 350-4 1968 - dustrial Hygiene Association Journal 29 conclusions were made in this paper The following With the exception of 4 of the 22 cosmetic taicum 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 signif- icant proportion of sales in the industry or to what extent the sourceosf the talc in these lations are the same as sources of talc four formu- specified for use in other talcum products in the competitive market The levels of silica chromium and nickel in these four products are sufficiently high however to be of concern in their potential to cause disease All of the 22 talcum products analyzed have an appre- ciable 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 anthophyllite and chrysotile as these are often present in fibrous tale 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 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 addressed a Dr. Selikoff of Mount Sinai School of Medicine outlined briefly the history of fibrosis in asbestos workers which has been known to years medical profession for for officials over 30 FDA was years He reported that a few there no apparent e JNJNL61_000001141 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 in the environment He felt that the new dimension added to the problem was the possi- bility 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 tale business for over 70 years Talc along with a whole host of other materials can give risteo a biological response & has not noted any adverse effects from the use of talc in either their employees or reported in the literature Talc manufactured by & is highly refined to produce a . platy tale Available data indicates that there is no health hazard associated with the use of cosmetic grade It was also pointed out that tale introduced surgically does not appar- ently 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 less than 5 microns in length reportedly do not cause lung damage This point however has not 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 tale would be resolved in the interest of the consumer rather than in the interest of the producer 000001142 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 tale ~ 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 talc Dr. Speil of Johns Manville Research Center reported that tremolite and chrysotile could be determined in tale at a level of about 0.5 by ray diffraction Dr. Speil felt however that the important question to be answered is How much gets into the lung of the person who is exposed He suggested that a model be set up to determine the real exposure values 3. Dr. Lewin a consultant for Whittaker Clark and Daniels reported that ray powder diffraction would be an ideal screening technique 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 Sinai reported that they use the following techniques to detect and determine asbestoform minerals light microscopy ray powder diffraction electron microscopy electron microprobe and electron diffraction During the discussion that followed Dr. Langer's presentation he was asked if he had analyzed a sample referred to 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 produced a high quality talc product 5 Dr. Norwood of Charles Pfizer and Company agreed that ray diffrac- tion would be the method choice for the analysis of asbestos in talc He indicated that by using step scanning and other sophisticated techniques you could probably detect down to 0.1 of chrysotile in talc . 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 talc If very few or no fibers are seen electron microscopy with electron diffraction should be used If many fibers are seen ray diffraction , should be used IN.INI 61 000004004 00044 Page6 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 will be sent to FDA by some of the participants at the meeting and these will be synthesized by FDA and circulated for comments & Henning Hening a John A. Wenninger 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 Ohio Irving J. Selikoff M.D. Arthur M. Langer Ph.D. William J. Nicholson Ph.D. C. J. Maggiore Ph.D. Mt. Sinai School of Medicine 11 Malcolm Ross Ph.D. Wilson Nashed Ph.D. Gavin Hildick M.D. R. F. Rolle Ph.D. T. H. Shelley Ph.D. A. Goudie Ph.D. Prof. F. D. Pooley Consultant W. T. Caneer Consultant Ian M. Stewart Ph.D. Consultant G. R. Grieger Ph.D. Consultant - Dr. Norwood HarolDd. Stanley Jr. Ph.D. Commr Harold Romer U. S. Geological Survey Johnson & Johnson oe 11 1 .01 11 11 " Charles Pfizer & Company 1 N.Y.C. Dept. of Air Resources S. R. MountsieJrr. Prof. S.Z. Lewin Consultant Whittaker Clark & Daniels 7) ; Paul Gross M.D. Sidney Speil Ph.D. Morris Kaplan Medical University of South Carolina Manville Consumers Union Norman Estrin Ph.D. Murray Berdick Ph.D. Cosmetic Toiletry & Fragrance Assn El . INDINITA INDINITA INDINITA AAannes-- 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 Hyman 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 1 11 It " 11 = 11 bi] i] 11 ** " = = = = " cc To all Attendees JAWenninger 9-10-71 INDINITA INDINITA INDINITA AAR Anes