Document DMV5eMX50wdQMQv0LVNEw7myO

DEPARTM ENT OF HEALTH, EDUCATION, AND W ELFARE PUDLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION W A S H I N G T O N . D .C . 202C4 October 6, 1971 on August 3, 197X Attached is a sun n ary of o u r recent Discussion S u z tiv n on `^Asbestos emd Talc," As mmy o f you rnm-% I have requested submissions o f de tailed analytic*--1 procedures frocj all of the laborstories represented which perforin such work, k t this writing, I have, recoined m o t , but not yet all, cr the raptorial requested, When the cubuicsions are c plefe, 1 shall proceed with the oynthonio of these Into a packages which will he circulated for ceariaats, / Thank you once again for your assistance and participation. l...................... ......7 ____ ? _.___ g Y>ire.ctor Division of Co lore and Cerrntios Techno Office of Product Technology 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 Color & 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 scientist, 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 analyses for the amount of asbestos in talcum powder will be obtainable, according to many of the participant, only through the use of a battery of specialized instrument and techniques, including >:~ray diffrac tion, polarizing optical microscopy, electron microscopy, and electron diffraction of elected 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. Weissler opened the meeting by outlining some of the event 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 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. 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 i 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 mineral which fit the above descriptions. The term "asbestoform minerals'* is perhaps most descriptive (1 ). b. The known varieties of asbestofom minerals can be divided into two main d u s s e s 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 agbestoform minerals. It accounts for more than 95% of the asbestos fiber produced today. There are five recognised asbestoform varieties of amphibole: crocidolite, amosite, anthophyllite, tremolite, and actinolit. Although the amphiboles are common rock-forming minerals, the ashestofona varieties are touch le$s abundant than chrysotile (1 ). c. The empirical formula of talc and some asbestoform minerals can be represented as follows: Talc, Hg3 Si4 0 10 (CH) 4 Serpentine Class Chrysotile, Mg3 Si2 O5 (OH) 4 (1) Spell, S. nd Lelneweber, J.P., Environmental Research 2 166-208 (1969 Page 3 Amphibole Class Anthophyllite (Mg, Fe)y Sig 022^*^ 2 Treraolite C&2 ^S5 Sig 022 (OH>2 Actinolite C&2 (Hg Fe) 5 Sig C>22 (0H) 2 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. His presentation, centered in part on a paper he co-authored entitled "Fibrous and Mineral Content of Cosmetic Talcum Products," Araer. In- du&trial Hygiene Association Journal. 29. 350-4 (1968). a in u i ii iw aC T w c n j,a a ja T ifmii i f n*imi agaJ T P a a -- ~m w i .Tniftimimn vti .Ti* k u b b ' ^-- conclusions were mads in this paper: The following ---- "With the exception of 4 cf 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 & 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. -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 pro bably contained minor amounts of tremolite, anthophy llite) and ehrysotile 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 &ddrese< themselves to this topic. a. Br. 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 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. Bildick$mitk, Director of Clinical Research for Johnson and Johnson (JlsJ), 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 "piety talc." Available Ccta indicates that there is no health hasard associated with the use of cosmetic grade talc. It wan also pointed cut"that talc introduced surgically does not appar ently cause mesotheliomas. c. Dr. Cross 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. 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. Br. Barzilai of the Bureau of Drugs reported that particulate matter in drug products ate 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 th interest of the producer. Page 5 6. Dr. Estrin of the Cosmetics, Toiletry end 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 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. Sis presentations were given outlining methods used in various laboratories. 1. Mr. Eieenberg 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. 2. Dr. Spell of Johns Manville Research Center reported that tremolit< and chrysotile 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 is: How much gcta 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 Hhittaker, Clark and Daniels reported that x-ray powder diffraction would be an ideal screening techniqw 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. Lsnger and Dr. M&ggiore of Mount' Sinai reported that they use the following techniques to detect and determine msbestoform miner als; light microscopy, x-ray powder diffraction, electron mierosco electron microprob and electron diffraction. During the discussi that followed Dr. hanger'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 talc. He added that all the talc producers represented at the meeting pro duced & high quality talc product. 5. Dr. Norwood of Charles Pfizer and Company agreed that x-ray dlffra tics would be the method of choice for the analysis of asbestos is 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 fetj or no fibers are seen, electron microscopy with elect: diffraction should be used. If many fibers are seen x-ray diffract should be used. Page b 7. In closing the meeting Dr. Weissler thanked the participants and sunsaarised 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. Oohn A. Wenninger Assistant Chief, Cosmetics Branch Division of Colors & Cosmetics Technology The following people attended the symposium: Lewis J. Crailey, Ph.D. National Institute of Occupational Safety and Health, Cincinnati, Obi 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 it it n Malcolm Rose, Ph.D. U. S. Geological Survey Wilson Hashed, Ph.D. Gavin Hildick-Siaith, M.D. R, F. Rolle, Ph.D. T. H. Shelley, Ph.D. A. Goudie, Ph.D. Prof. F. D. Pooley (Consultant) W. . Cancer (Consultant Ian M. Stewart, Ph.D. (Consultent) G. R. Grlcger, Ph.D. (Consultant) Johnson & Johnson Dr. Norwood Rarold B* Stanley, Jr., Ph.D. Charles Pfizer & Company h Commr. Harold Rmer #N.Y.C. Dept, of Air Resources S. R. Mounts1er, Jr. Prof. S.Z. Lewln (Consultant) Whittaker, Clark & Daniels it Paul Gross, M.D. Medical University of South Carol Sidney Spell, Ph.D. Johns-Manvilie Morris Kaplan Consumers Union Norman Estrin, Ph.D. Murray Berdick, Ph.D. Cosmetic, Toiletry A Fragrance As " Herman F. Krayblll, Ph.D. Robert M. Schaffner, Ph.D. Alfred Weiss1er, Ph.D. John M. Gowdy, M.D. Sylvan H. Wewburger, 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. Barsilai, M.D. Jule K. Lamar, M.D. ' Mrs. Manjest Singh Armand R. Cssola, Ph.D. M. A, Weinberger, M.D. Paul E. Coraeliussen K. S. Heine Albert C. Kolbye, M.D. Page 7 Food and Drug Administration " " " " ** " *' " " " M " M " " " " ." ce: To all Attendees 4ETHOD :ical . :roscopy FIBER ANALYSIS QUAL. QUANT. Yes Presence and `Kind of Fiber Yes Point and Area Count MINIMUM PARTICLE SIZE DETECTABLE 0. LOWER LIMIT OF DETECTABILITY Not Applicable inning ictron :roscopy Presence of Fiber Yes Point and Area Count ^0 Not Applicable ictron :roscopy Yes Presence and Kind of Fiber Yes Point and Area Count ^ 0 Not Applicable tay fraction Kind of Fiber Yes Minimum. Particle rv 0.5% (wt/wt) . Size for Diffraction w is ca. 0.1 More Favorable Cases From? R. F. Rolls, Ph.D Johnson and Johnson Research Division New Brunswick, N.J. 08903 TIME FOR QUANTITATIF ANALYSIS 1/2 Day One Day One Day Two Hours to a Day Depending on Methoc DIVISION OF COLONS AND COSMETICS TECHNOLOGY FOOD AND DRUG ADMINISTRATION. WASHINGTON, D.C. ASBESTOS AND TALC Discussion Session, August 3, 1971, Room 1409, 200 C Street, S.W, Moderator: Dr, Alfred Weissler 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 3, Biological-Medical Significance of Asbestos and Other Fibers Dr. I. J, Selikoff, Mt. Sinai School of Medi< Dr. G. Kildick'-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 6, Cosmetics Industry Interest In Asbestos - Dr. Norman Estrin CTFA a 7, Analytical Methods for Asbestos - William Eisenberg, FDA Dr. S, Spell, Johns Msnville S, R Mountsiex*, Jr., Whittaker, Clark & Dr. A. M, Langer, Mt. Sinai Dr, Norwood, Chss. Pfizer & Company Dr. W. Hashed et al., Johnson & Johnson