Document eL6gN30x67rgBm1mVxzB7ZYE

FILE NAME: Colgate (COL) DATE: 1971 Aug 3 DOC#: COL004 DOCUMENT DESCRIPTION: Memo of Symposium on Asbestos and Talc with Cover Letter DEPARTMENT OF HEALTH, FDUCATION, AND WELFARE PUDL1C HEALTH SCTiViCE FOOD AND DrUG AOMJ fi STRATION WASHINGTON, P.C. 20204 OefcelK-r 6. 197! To: P s r tic ip a its in "tbeatoci and Tale" Dlhcutifior. Cessina afe FD'.. 0X2 ugus; 2'f 1971 Atfr.ebed ir; a su? lory o f enr reeaut )>7sonselc 0n "Asfceafcos A?i.d T a le ," As tuay o f ycu rii.', I havo". i/eques t-cl fiiibifiii-sicns or La- Caline! analytiiei l pcoceduirc-n i n a a l l u f ths laoa atari os renreernfcc-d whifb parforvn such Kork, Ai: t:hir. TaririLog, ' l>r ve ; s-.ai\p<; trai:, brK nafc >01, a l!., c i tiw w a te r? e 1 r e q u a s '-.ed, KV;u tlo? a n h -.'.L ^v.i^.-. .,,re e t plofe, I pvcecod -Neh t'-0 .-ynfc.'n.ia af ttiK.n 'H.ita a uhi eh o l i i 1-a cr-xulaLc: lo.? crr..,.,`5n!:c, T5i.?el: you once ageJn f a r yuur sesiatanoe tzd p-rntAcioafcioa, Sineere ly yr,uirs; / ADlifvrieiddo nVaiosfslCcso:l,orePhr.aCd,,CAectiae^ic si-i'lrocchtic'r-:; Offico of Prodiiol, Technology QE-CPC2-00000001 MEMORANDUM OF A SYMPOSIUM AuguBt 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 products, and the inhalation health hazards associated with their presence, are subjects of current interest but differing reports. 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 that most talcum powders of major manufacturers are relatively free of asbestos. Nevertheless, on behalf of consumers, FDA is working on the details of a laboratory procedure for the analysis of asbestos in talcum powders which will give consistent meaningful results. Accurate analyse 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 x-ray diffras 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 aa the medical significance of asbestos and other fibers, and the mineralogy of asbestos and talc ore deposits. INTRODUCTION Dr. Weissler opened the meeting by outlining soma 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 Kretchraer (Administrt Environmental Protection Agency, New York City) to HEW Secretary Richardson, on June 28, 1971 the FDA was taking steps to investigate the problem of asbe tos particles in talc. . QE-CPC2-00000002 As & 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 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 talc. During this presentation and the discussion which ensued the following salient points emerged: a. Definition: Asbestos is a generic tern 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 descriptive (1 ). b. The known varieties of aobestoform 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 io by far the most common of the asbestoform minerals. It accounts for more than 957. of the asbestos fiber produced today. There are five recognised asbestoform varieties of amphibole: crocidolite, smoaite, snthophyllite, tremolite, and actinolita. Although the amphiboles are common rockforming minerals, the asbeotofona varieties are touch leps abundant than chrysotile (1 ). c. The empirical formula of talc and some asbestoforsa minerals can be represented as follows: Talc, Mg3 Si4 O iq (OH)^ Serpentina Class Chrysotile, Kg3 Si2 O5 (OH)^1 (1) Speil, S. and Leineweber, J.P., Environmental Research 2 166-208 (1969 QE-CPC2-00000003 Amphibole Ciana Anthophyllite (Mg, Fe)? Sig 022(OH) 2 Treraolite Ca2 Mg5 Sig 022 (0H) 2 Actinolite Ca2 (Mg Fe) 5 Sig 022 (0K) 2 Page 3 if i e^ : i T r l t 0 flD? large varlatioM in the composition T h e M f Z * Wit5 iD a/ eUtively H area of a g i v S deposit, involved? dCpe C 3 gre3t eXCent Q the mineralogy Lli* s S " TM for Safety ,,,d on the fibrous content of cosmetic talcum products. His "Fibrous and*Mineral^ part on a paper he co-authored entitled l a t l i T i and Mineral Content of Cosmetic Talcum Products," Amar. m - 350-4 (19e8)* "With the exception of h cf the 22 cosmetic tsicua products enalysed, 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 sources of the talc in these four formu lations are the same as sources of talc 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. * t l L f ri! 22 tSlcum pm3ucts analysed have an appre,, fibef content> ranging from 8 to 30% by count ' the total talcum particulates, and averaging 19%. ine fibrous material was predominantly talc but pro bably contained minor amounts of tremolite, anthophy- Uite; and chrysotile as these are often present in fibrous taic mineral deposits. Cosmetic talcum produetc 8J?yUu 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." L tJirJ ^ iscussioa topic on the program dealt with the biological and h " i v L 8t t L T t o p i c ? `b<,ets " d other 1 W - Ihree spe`ltera * i f : f , E S1 " 1 of HxliciM outlleed briefly the history, of fibrosis in asbestos workers which has been known to the medical profession for over 30 rears. Ha wnorfcH h -,.,- n years ago when he met with FDA officials there^was^no apparent QE-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 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 leas than occupation levels. b. Dr. Kildick-Smitfc, Director of Clinical Research for Johnson and Johnson (J&J), outlined briefly the medical aspects of talc production and uses. He reported that J&J 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. J6sJ has not noted any adverse effects from the use of talc in either their employees or reported in the literature. Trie manufactured by J&J is highly refined to produce a "piety talc." Available Cc'ca indicates that there is no health hazard associated with the use of cosmetic grade talc. It was also pointed out'that talc 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 nan or animal. Intratracheal injection of talc in hamsters caused no ill effects. In these animals no lung scarring was seen. AGbesto3 particles less then 5 microns in length reportedly do not cause lung damage. This point, however, has not been definitely confirmed. 4. Dr. Krsybill 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. Barsilai of the Bureau of Drugs reported that particulate matter in drug products 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 then in the interest of the producer. QE-CPC2-00000005 Page 5 6. Dr. Estrin of the' Cosmetics, Toiletry and Fragrance Association reported that the Association waB ready to join with FDA and the academic community to determine if there is a consumer safety problem with 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 polarising microscope, for the detection of asbestoform minerals in talc. 2. Dr. Spell of Johns Manville Research Center reported that tremoliti and chrysotlle could be determined In talc at a level of about 0,5% by x-ray diffraction. Dr. Spell felt, however, that the important question to be answered isi 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. Levin, a consultant for Whittaker, Clark and Daniels reported that x-ray powder diffraction would be an ideal screening techniqm 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 follov?ing techniques to detect and determine asbestoform miner ale; light microscopy, x-ray powder diffraction, electron raicrosco electron microprobe and electron diffraction. During the diecussi that followed Dr. Langer's presentation he was asked if he had analyzed a sample, referred to as 344-L, from Johnson and Johnson. He said that ho 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 Pfiser and Company agreed that x-ray diffra tion would be the method of choice for the analysis of asbestos in talc. He indicated that by using step scanning and other sophist! techniques you could probably detect down to 0 .1% of chrysofcile it talc. 6. Dr. Hashed of Johnson and Johnson introduced Dr. Nolle 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 talic. If very few or no fibers are seen, electron microscopy with elect; diffraction chould be used. If many fibers are seen x-ray diffract should be used. QE-CPC2-00000006 Page b 7. In closing the meeting Dr. Weissler thanked the participants and summarised 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, end these will be synthesised by FDA and circulated for comments. A. Wenninger (j Assistant Chief, Cosmetics Branch Division of Colors & Cosmetics Technology The following people attended the symposium; Lewis J. Crailey, Ph.D. Irving J. Selikoff, M.D. Arthur M. Langer, Ph.D, William J. Nicholson, Ph.D. C, J. Maggiore, Ph.D. National Institute of Occupational Safety and Health, Cincinnati, Ohi Mt. Sinai School of Medicine It II If Malcolm Ross, Ph.D. Wilson Hashed, Ph.D. Gavin Hildick-Smith, M.D. R. F. Rolle, Ph.D. T. H. Shelley, Ph.D. A. Goudis, Ph.D. Prof. F. D. Pooley (Consultant) W. T. Csneer (Consultant Ian M. Stewart, Ph.D, (Consultant) G. R. Gricger, Ph.D. (Consultant) U. S. Geological Survey Johnson & Johnson II II II M II II . II ' It Dr. Norwood Harold D, Stanley, Jr., Ph.D. . Charles Pfiser & Company " Corsair. Harold Rmer S. R. Kountsier, Jr. Prof. S.Z. Lewin (Consultant) ,N.Y.C. Dept, of Air Resources Whittaker, Clark & Daniele It Paul Gross, M.D. Sidney Spetl, Ph.D. Morris Kaplan Norman Es triti, Ph.D. Murray Berdick, Ph.D. Medical University of South Carol Johns-Kanvilie Consumers Union Cosmetic, Toiletry A Fragrance Ae It QE-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 . Wenninger Charles J. Kokoski, Ph.D. George Thompson, Ph.D. Dennis J. McGrath, M.D. J. U. Cook Byraan R. Gittes William V. Barzilai, M.D. Jule K. Lamar, M.D. Mrs. Menjeet Singh Armand R. Casola, Ph.D. M. A. Weinberger, M.D. Paul E. Coraeliussen K. S. Heine Albert C. Kolbye, M.D. Page 7 Food and Drug Administration IT I It II II If I It II It QE-CPC2-00000008 1ETHOD :ical :roscopy inning ctron :roscopy FIBER ANALYSIS QUAL. QUANT. Yes Presence and Kind of Fiber Yes Point and Area Count MINIMUM PARTICLE SIZE DETECTABLE r* 0.5/^-- Presence of Fiber Yes Point and Area Count ^ 0 LOWER LIMIT OF DETECTABILITY Not Applicable Not Applicable ictron jroscopy Yes Presence and Kind of Fiber Yes Point and Area Count 0.01/*- Not Applicable tay `fraction Kind of Fiber Yes (wt/wt) Minimum Particle 0.5% Size for Diffraction w is ca. 0.1 More Favorable Cases From: R. F. Rolle, Ph.D. Johnson and Johnson Research Division New Brunswick, N.J. 08S03 TIME POR QUANTITATI' _______ ANALYSIS 1/2 Day One Day One Day Two Hours to a Day Depending on Methoc QE-CPC2-00000009 d i v i s i o n o f c o l o n s AND COS.'ETICS t e c h n o l o g y IOOD AND DRUG ADMINIS TEATION. WASHINGTON, D.C. ' ASBESTOS AND TAT.r Discussion Session August 3, 1971, Room 1409, 200 C StreetModerator: Dr. Alfred Weissler .Discussion Tonics S W ' ' 1. Asbestos and Talc Hineral Deposits - Dr. Malcolm Ross U. S. Geological Survey 2. Fibrous Content of Cosmetic Tale,TM Products - Dr. L. J. Cralley NIOSH 3. Biological-Medical Significance of Asbestos and Other Fibers - ' Dr. I. j. Selikoff, Mt. Sinai School of Medii Dr. G. Hildick-Sraith, Johnson & Johnson Dr. Paul Gross, Medical University of S.C. 4. Current FDA Interests 1 Asbestos - Dr. R. E. Barailai, Bureau of Drugs Dr, J. K, Lamar, Bureau of Drugs Dr. H, F. Kraybill, Bureau of Foods 5. Consumer Interest in Asbestos - Morris Kaplan Consumers Union 6. Cosmetics Industry Interest in Asbestos - Dr. Herman Estrin . - CTFA 7. Analytical Methods for Asbestos - William Eisenberg, FDA Dr. S, Speil, Johns Manville S. R, llountsier, Jr., Whittaker, Clark & Dr. A. M. Langer, Mt. Sinai Dr. Norwood, Chas. Pfizer & Company Dr. W. Hashed et al., Johnson & Johnson QE-CPC2-00000010