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MEMORANDUM OF A SYMPOSIUM August 3, 1971 ASBESTOS AND TALC Held at the Food and Drug Administration 200 TO/' Street, S.W. Washington, ;).C. 20204 Moderator : Dr. Alfred Weis1er, 1)5.rector Division of Colore & Cosmetics Technology SUMMARY The amount of asbestos fibers- in talcum powder products, and the Inhalation health hasards associated with their presence, are -subjects of current interest but differing reports. At s symposium held on August 3 at the Food and Drug Administration attende' by over 40 scientists, physicians and consumers, It was generally agreed thdfc most talcum powders of major manufacturers are relatively free of asbestos. Fevertheloss, 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. l\ Accurate analyses for the amount of asbestos in talcum powder will be obtainable, according to many cf the participants, only through the use of c battery of specialised instruments and techniques, including x*ray diffrat tlon, polarising optical microscopy, electron microscopy, and electron diffraction of selected particles. In addition to extensive discussions of the analytical methods for asbestos asused by various laboratories, the group also considered such topics the medical significance of asbestos and other fibers, and the mineralogy of asbestos and talc ore deposits. INTRODUCTION Dr. Ueiesler opened the meeting by outlining soma of the events which had brought the question of asbestos particles in talc to the attention of FDA. He indicated that In response to a letter from Jerome Kretchmsr (Administrai Environmental Protection Agency, Nev: York City) to HEW Secratary Richardson, on Juno 28,'971 the FDA vas taking steps to investigate the problem of asbe tes particles in talc. As n first: efc'ep the FDA would like to establish a laboratory procedures for the etcjemination of asbestos in talcum powder products that will give meaningful and ccurlstent 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 partial pant followed by informal discusslens which served to pool the knowledge of the experts present. A list of the diseusuvion topics is attached. GENERAL DISCUSSION 1. Dr. Ross of the U.S. Geological Survey made the first presentation. Dr. Rosts, & ralnerologist, outlined the various associations of asbestos mineral species with talc. During this presentation and the discussion which ensued the following salient points emerged: iu Definition: Asbestos is a generic term for a variety of hydrated silicate minerals which hav.e one eor-noa attribute, the ability to be separated into relatively soft, silky fibers. Although the name is ord1.n avi.iy associated with those varieties which have technologic importance, it is applicable to all minerals which fit. the above descriptions. The tern "ashesCoform minerals'' is perhaps moot descriptive (1 ). b. The icctova -varieties--of e&hmtonc' minerals c m be divided into two main classes on the basis of their crystal structures: (serpentine and arophibolcs. The sole member ox the serpentine class is chrysotile asbestos, which is by far the* most, common of the ashestoform mineral. It accounts for more than 95% of the asbestos fiber produced today. There are five recognised asbestoform varieties of amphibole: crocidolite, amostfce, anthophyllite, tremollte, and actinollte Although the amphibolic are common rockforming minerals, the asbestoforra varieties are much leys abundant than chrysotile (X). c. The empirical formula of talc and soma asbestofora minerals can be represented m follows: Talc, Mg3 Si* Oio (0H)4 Serpentine Class Chrysot lie, Hgg Si2 Og (OH) 4 (1) Spoil, S. and Leirteweber, J.P., Environmental Research 2 166-208 (1969 /Uophibole Class Anthophyllite (Mg, Pe)y Sig Tremolite C&2 Mg$ Slg O22 (011)2 \ Actinollte C&2 (Mg ?e>5 Sl^ (0I1>2 d. I t i s not unusual to fin d la rg e v a r ia tio n s In the com p osition o f a mineral w ithin a r e la t iv e ly small, area o f a given d e p o sit. The d iffe r e n c e s depend to a great ex ten t on the m ineralogy in v o lv e d 2, Dr. Cralley of the Rational Institute for Occupational Safety and Health spoke on the fibrous content of cosmetic talcum products, Hie presentation, centered in part on a paper he co-authored entitled "Fibrous and Mineral Content of Cosmetic Talcum Products," Atr*ny 7 n dnnfcrial Hygiene Association Journal. 29, 350-4 (1968). The following conclusions were made in this paper; ''Uifck 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. Xt is not known whether the four product's represent a signif icant proportion of sales in the industry or to what -extent -the courees of the tale.in fchaee .four fom*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 arc 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 \ms predominantly talc but prob&bly contained minor amounts of trcmolite, nnthophyHite, and chryoctila 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 with the biological and medical significance of asbestos and other fibers. Three speaker*? address themselves t4o this topic. a. Dr. Solikoff of Mount Sina! School of Medicine outlined briefly the history of fibrosis in asbestos workers which he,3 been known to the medical profession for over 30 years lie reported that a few yerrS' ago when he n:*t with FDA officials there was no apparent problem presented to the general population with regard to asbestos. It vaz considered at that time to be mainly an occupational problem. He reported that recently acquired knowledge has greatly increased hie concern over the whole question of asbestos fibers in the environment. He felt that the new dimension added to the problem was the possi~ hllity that lung cancer may reau.lt even from exposures et less than occupation levels. b. Dr. Hildick~SKith, Director of Clinical Research for Johnson and Johnson (JC.-J), outlined briefly the medical aspects'of talc production and uses. He reported that J6J has been in the talc business for over 70 years. Talc, along with a whole hoot of other materials can give rise to a biological response. J&J has not noted any adverse effects from the use of talc in either their employees or reported in the literature. Talc manufactured by J&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. In was also pointed out that talc introduced surgically does not appar* ently cause mesotheliomas, 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 oatis-ed no-111 -offacto . 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. Barzil&i 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 ceem 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. & /* 'V A 6, Dr. Eotrin of the Cosmetici?, Toiletry and Fragrance Abb Gelation reported that the Association was ready to join with FDA and .ths academic community to determine if there Is a consumer safety problem with talc. ANALYTICAL METHOD01.0GY The afternoon session was devoted to a discussion of analytical methods that could be used for the identification and determination of asbestos in talc. Sir presentations were given outlining methods used in various laboratories. 1* Mr. Eiscnbcrg of the Division of Microbiology reported on optical methods, such as the use of the polarising microscope, for the detection of asbectoform minerals in talc. 2. Dr. Spell of Johns Manville Research Center reported that tremoliti and chryaotile could be determined in talc at a level of about 0.5% by x-ray diffraction. Dr. Spell felt, however, that the important question, tc be answered is: Kov much gets into the lung of the person who is exposed? He suggested that & model be set up to determine the real exposure values. 3. Dr. Lewin, a consultant for Whittaker, Clark and Daniels reported that x-ray powder diffraction would be an Ideal screening techniqm for rapidly determining which camples of talc contain asbestos minerals. He indicated that there are talcs on the market which appear to be objectionable. A. Dr. Langer and Dr. Maggiore of Mount Sinai reported that they use the following techniques to detect and determine asbestoform miner als; light microscopy, x-ray powder diffraction, electron micrcsco electron raicroprobe and electron diffraction. During the discuss! that followed Dr. Langer!a presentation he was asked if he had analysed a cample, referred to.as 344-L, from Johnson and Johnson. Ha said that he had ana 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 diffrs tion would be the method of choice for the analysis of asbestos It talc. He indicated that by using step scanning and other sophioti techniques you could probably detect down to 0.1% of chrysotilo is talc. 6 . Dr. Hashed of Johnx?on and Johnson Introduced Dr. Rollo who roade available a table which outlined "Methods of Analysis of Fibers in Talc." (Copy attached). Dr. Lolle 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 elect diffraction should be used. X many* fibers are seen x-ray diffrac should be used. 7. Xn closing the meeting Dr. Weiseler thanked the participants and fsutm&vized the saost'promising approaches which might bo 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 synthesised by FDA and circulated for conseenta. \ 0 x' * ATohn A. Wenninger " Assistant Chief, Cosmetics Branch Division of: Colors & Cosmetics Technology The following people attended the symposium: Lewis J. Oralley, Fh.D* National Institute of Occupational Safety and Health, Cincinnati, OhS Irving J. Selikoff, M.D. Arthur M. Langer, Ph.D, Will less J. Nicholson, Fh.D. C. J Hagglere, PhD. lit. Sinai School of Medicine H (1 <1 Malcolm Rose, Ph.D. U S. Geological Survey ftilsoa Hashed, Ph.D. Gavin Hildick-Saith, M.D. R. F. Rolls, Ph.D. T. :H. Shelley, Ph.D. A. Goudie, Ph.D. Prof. F. B. Pooley (Consultant) W . |T . Caneer ( C oneu11ent Ian M. $tew,rt, Ph.D. (Consultant) G. ;R. Griegor, Ph.D. (Consultant) Johnson & Johnson u II It II II ft 11 1! Dr. Norwood Harold D. Stanley, Jr., Ph.D. Charles Pfizer & . Company ti Consnr, Hat old Rmer ^ N.Y.C. Dopt. of Air Resources S. R. Mounts1er, Jr. Prof. S.Z. L e w in (Consultant) Whittaker, Clark 6. Daniels u Paul Gross, K.D. Medical University of South Caro! Sidney Spell, Ph.D. Johns-Manvilie Morris Kaplan Consumers Union Norman Es trin, Ph.D . Murray Berlck, Ph.D. Cosmetic, Toiletry & Fragrance A it He m a n F. Kraybill, Ph.I). Robert M. Schaffner, Ph.D. Alfred Weissler, Ph.D. John M. Go'wdy, K.D. Sylvan H. Mowburger, Fh,I>. John A, Wenningor Charles J,, Kokoski, Ph.D. George Thompson, F h .D . Dennis J = licGrath, M.)). J. TJ. Cook Byaan R . Gi 11es William V. n&rsilai, M.D. Jule K. Lamar, K.D. Kr * Hanj eet Singh Arc&nd R. Casola, Ph.D. H. A. Weinberget, M.D. Paul . Gerne Hussen K. S. Reine Albert 0. SColbye, K.D. Food and Drug Administration !t 15 I II \ N et ii et ii tt ei ei 81 ft II II II 91 II cc: To all Atfcendees JAUenningersvbl:9ra10"71 THOD cal . oscopy FIBER ANALYSIS MINIMUM PARTICLE QUAL ,, QUANT. SIZE DETECTABLE Yes Presence and `Kind of Fiber Yes Point and Area Count * r-' 0 .Sf*-- . LOWER LIMIT OF DETECTABILITY Not Applicable ming :tron :oscopy Presence of Fiber Yes Point and Area Count rss 0 Not Applicable :tron :oscopy Yes Presence and Kind of Fiber Yes Point * and Area Count <"^0.01^- Not Applicable ay fraction Kind of Fiber Yes (wt/wt) /i From: R. F. Rolle, Ph.a. Johnson and Job na'cn > Research Livision New Brunswick, N.J. 03903 Minimum Particle c* 0.5% Size for Diffraction w is ca, 0.l//~ More Favorable Cases TIME FOR QUANTITATI ANALYSIS 1/2 Day One Day One Day Two Hours to a Da Depending on Meth - Division OF COLORS AND COSMETICS TECHNOLOGY FOOD ANT) DRUG ADM INTS TRATI ON WASHINGTON, D.C. ASBESTOS AND TALC Discussion Session, August 3, 1971, Room 1409, 200 C Street, S eW. Mod erst:or: Dr, Alfred Weissler Discession Tonics 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 3 r Biological-Medical Significance of Asbestos and Other Fibers Dr* I. J. Selikoff, Mt, Sinai School of Medic , Dr. G. HiId.ick-Smith, Johnson & Johnson Dr. Paul Gross, Medical University of S.C. 4. 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 5 Consumer Interest in Asbestos - Morris Kaplan Consumers Union .. Se Cosmetics Industry Interest in Asbestos - Dr. Norman Estrin CTFA r. Analytical Methods for Asbestos William Eisenberg, FDA Dr. S. Spell, Johns Manville S. R. Mountsier, Jr., Whittaker, Clark & Dr. A. M. Danger, Mt. Sinai 'Dr, Norwood, Chas. Pfizer & Company Dr. \K Nashed et al*, Johnson & Johnson 6'