Document R20GkVyaQ5wjbx0Q4bq2NdmGX

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 n; DEPARTMENT OF HEALTH, FDUCATION, AND PUBLIC HEALTH SERVICE FOOD AND QRUG ADMINISTRATION W A S H IN O T O M , D C . 2020-1 W ELFARE Ocfceb&r 6, 1971 To: P a r ti ip s n ts in "Ashestoo and T ale" Discuafiicn Sasso n at FUA osa August 3, 1971 ttAcbed s a suraiary o f onr recen t D irsn ssian Euscen ort -l SS.'' As raptiy o f ycu - w , I havfc raquestod sabisissions o da~ t s l e d anslyfrienl ptoeeduxoa fr e s a i l u f Cha la b o r a te r a s r&pressnted which p e rfo ra eoch Kork. AE Chis n rlcin g, I htva rscaive* inna:, buf. nofc yac s i l . c f tiie Esiaterisl rcq ^ sse d . Whea Cha subciroionn re ca" p i s t a , I & hall proco wxfch cha aynfehoois o f fehete la t o a p.-rd-.age whieh w i l l l-a circuate?. or ccncr,safes. Thmk you once again fo r yemr asssuinaa and p a r tic ip a c i n . Sittceraly ycurs, AL > <. ,/-l \,' lfre W aissler, Ph.D .t Acting Directas D iv is i n o f Color.? and Cerrle ic s Tfichas O ffic a o f Produce Taehnelogy QE-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 Weiss1er, 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 sad Drug Administration attends' by over 40 scientists, physicians and consumers, it waa generally agreed that most talcum powders of major manufacturers are 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 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 x-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 medical significance of asbestos and other fibers, and the mineralogy of asbestos and talc ore deposits. INTRODUCTION Dr. Weiss1er opened the meeting by outlining some of the events which had brought the question of asbestos particles in talc to the attention of FDA. Ha indicated that in response to a letter from Jerome Kretchmer (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 Ab 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 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 ainerologist, 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 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 chrysotlle 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 recognised asbestoform varieties of amphibole: crpcidolite, smoslte, anthophyllite, tremolite, and actinolita. Although the amphiboles are common rock-forming minerals, the asbestoform varieties are much le#s abundant than chrysotile (1). c. The empirical formula of talc and some asbestoform minerals can be represented as follows: Talc, Mg3 Si4 Oio (OH)^ Serpentine Class Chrysotile, Mg3 Si2 O5 (0H>4 (1) Speil, S. and Leineweber, J.P., Environmental Research 2 166-20S (1969 QE-CPC2-00000003 Amphibole Class Page 3 Anthophyllite (Kg, Fe)? Si8 022(OH) 2 Tremolite Ca2 Mgs Sig 022 (0H>2 Actiaolite Ca2 <Mg Fe)s Sig <>22 (0H) 2 4. It ia 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 Rational Institute for Occupational Safety and Health spoke on the fibrous content of cosmetic talcum products. His presentation, centered in part on a paper he co-authored entitled "Fibrous and Mineral Content of Cosmetic Talcum Products," Amer, In* dugtrial Hygiene Association Journal. 29, 350-4 (1968). The following coneluoiesis were made in this papers "With the exception cf 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 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 aa sources of talc specified for use in ocher talcum products in the competitive market. The levels of silica, chromium, and nickel in these four products are sufficiently high, however, to he of concern in their potential to cause disease. . -All of the 22 talcum products analysed have an appre ciable fiber content, ranging from 8 to 30% by count r the total talcum particulates, and averaging 19%. The fibrous material was predominantly talc but pro bably contained minor amounts of tremolite, anthophy- llitej and chrysoeile 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 speakers address! themselves to this topic. . a. Dr. Selikoff of Mount Sinai School of Medicine outlined briefly the history, of fibrosis in asbestos workers which has been known to the medical profession for over 30 years. He reported that a few 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. Rildick-Smltfa, Diractor 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. J&J 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 "platy talc." Available data 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 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. Darsilai of the Bureau of Drugs reported that particulate matter in drug products afa 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. QE-CPC2-00000005 Page 5 6. Dr. Estrin of the Coameti.cs, Toiletry and Fragrance Association reported that the Association was ready to join with FDA and the academic community to determine if there is a consumer safety problem with talc'. ANALYTICAL METHODOLOGI The afternoon session was devoted to a discussion of analytical methods that could be used for the identification and determination of asbestos in talc. Sis presentations were given outlining methods used in various laboratories. 1. Mr. Eiaenberg 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. 3. Dr. Lewin, a consultant for Whittaker, Clark and Daniels reported that x-ray powder diffraction would be an ideal screening techniqui 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 miner alsj Light microscopy, x-ray powder diffraction, electron microsco electron microprobe and electron diffraction. During the diacussi that followed Dr. anger's presentation he was asked if he had analyzed a sample, referred to as 344-L, from Johnson and Johnson. He said that he had and that it was a high quality calc. . He added that all the talc producer's represented at the meeting pro duced a high quality talc product. 5. Dr, Norwood of Charles Pfizer and Company agreed that x-ray diffra tion would be the method of choice for the analysis of asbestos it talc. He indicated that by using.step scanning and other sophist! techniques you could probably detect down to 0.1% of chrysotile ir talc. 6 . Dr. Hashed of Johnson and Johnson introduced Dr. Rolle who made available a table which outlined "Methods of Analysis of Fibers in Talc." (Copy attached). Dr. Rolls 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, if many fibers are seen x-ray diffracl should be used. QE-CPC2-00000006 Page 6 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 synthesized by FDA and circulated for comments. -'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, Ohi Irving J. Selikoff, M.D. Arthur M. Danger, Ph.D. William J. Nicholson, Ph.D. C. J. Kaggiora, Ph.D. Mt..Sinai School of Medicine , " " " Malcolm Ross, Ph.D. Wilson Hashed, Ph.D. Gavin Mldick-Siaith, R, P. Rolla, Ph.D. T. H. Shelley, Ph.D. A. Goudie. Ph.D. M.D. U. S. Geological Survey Caneer (Consultant (Consultant) G. R. Grieger, Ph.D. (Consultant) Dr. Norwood Harold D Stanley, Jr., Ph.D. ' . Charles Pfizer & Company " Coemr. Harold Roraer cN.T.C. Dept, of Air Resources S . R. Kountsier, Jr. Prof. S.2. Lewin (Consultant) Whittaker, Clark & Daniels Paul Gross, M.D. Sidney Spell, Ph.D. Medical University of South Carol Johns-Kanvil le Morris Kaplan Consumers Union N o m e n Es trio, Ph.D. Murray Berdick, Ph.D Cosmetic, Toiletry A Fragrance Ae ir - QE-CPC2-00000007 Herman. F. Krayblll, Ph.D. Robert M. Schsffnsr, Ph.D. Alfred Weiss1er, 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. Jale K. Lamar, M.D. " Mrs. Maajeet Singh Armand R. Casla, Ph.D. M. A. Weinberger, M.D. Paul E. Cornellussen K. S. Hine Albert C. Kolbye, M.D. ' Page 7 Food and Drug Administration It If II It II It it ft If tl . It It ft tt tt It QE-CPC2-00000008 4ETHOD :ical . :roscopy FIBER ANALYSIS QAL. QUANT. Yes PreicncG and ' Kind of Fiber , Yes Point and Area Count MINIMUM PARTICLE SIZE DETECTABLE r-' 0.5/-*- LOWER LIMIT OF DETECTABILITY Not Applicable TIME FOR QUANTITATI' ANALYSIS ' 1/2 Day inning ictxon :roscopy Presence of Fiber Yes Point and Area Count Q.lyi*- Not Applicable One Day ;ctron ;roscopy lay fraction Yes Presence and Kind of Fiber Kind of Fiber Yes Point and Area Count 0.01^-- Not Applicable Yes Minimum. Particle ^ 0.5% (wt/wt). Size for Diffraction w is ca. 0.1^ ' ' More Favorable Cases One Day Two Hours to a Day Depending on Metho< From: R. F. Rolle, Ph.D. Johnson and Johnson Ragearch Division Sew Brunswick, N.J. 08S03 QE-CPC2-00000009 DIVISION OF COLONS AND COSiETICS 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 Discussion Topics S.W, 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. Biological-Medical Significance of Asbestos and Other Fibers - ' Dr. I. J. Selikoff, Mt. Sinai School of Kedit Dr. G. Hildick-Sroith, 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 ' 6 . Cosmetics Industry Interest in Asbestos - Dr. Norman Estrin CTFA * - 7. Analytical Methods for Asbestos - William Eisenberg, FDA * Dr. S. Speil, Johns Msnville S. R. Mountsier, Jr,, Whittaker, Clark & , Dr, A. M. Langer, Mt. Sinai Dr. Norwood, Chas. Pfizer & Company ' Dr. W. Hashed et al., Johnson & Johnson QE-CPC2-00000010