Document QxKLbm8QEoyy0byVyNJKJDg5

FILE NAME: Colgate (COL) DATE: 1971 Aug 3 DOC#: COL101 DOCUMENT DESCRIPTION: Memorandum of an FDA Symposium - Asbestos and Talc MEMORANDUM OP 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 Colors & Cosmetics Technology TMF'S JNJ-95 SUMMARY The amount of asbestos fibers i n 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 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 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. Weiss ler opened the meeting by outlining some 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 Kretchmer (Administrator Environmental Protection Agency, New York City) to HEW Secretary Richardson, on June 28, 1971 the FDA was taking steps to Investigate the problem of asbes tos particles in talc. JNJNL61 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 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 mineralogist, 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 chrysotile asbestos, which is 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, amosite, anthophyllite, tremolite, and actinollte. . Although the amphiboles are coumon rock-forming minerals, the asbestoform varieties are much leps abundant than chrysotile (1). c. The empirical formula of talc and some asbestoform minerals can be represented as follows: Talc, Mg3 SI4 O 10 (<)4 Serpentine Class Chrysotile, Mg3 Si2 O5 (OH)4 (1) Spell, S. and Lelneweber, J.P., Environmental Research 2 166-208 (1969) Amphibole Class Page 3 Anthophyllite (Mg, Pe)y Sig ( ^ ( O H ^ Tremolite Ca2 Mgs Slg O22 (OH)2 ' Actlnollte Ca2 (Mg Fe>5 Sig Oj2 (OH)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 dustrial Hygiene Association Journal. 29. 350-4 (1968). The following coudlusicr-S re made in this paper: "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 signlf- leant 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. Ali 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 chrysotile 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 addressed 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 JNJNL61 000001141 Paga 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. Hildlck-Smith, 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 tise 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. 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. Krayblll 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 restudled. 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 talc would be resolved in the interest of the consumer rather than in the interest of the producer. JNJNL61 000001142 Page 5 6. Dr. Estrin of the Cosmetics, 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 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 polarizing microscope, for the detection of aabestoform minerals in talc. 2. Dr. Spell of Johns Manville Research Center reported that tremolite and chry80tile 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 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 x-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 miner als; light microscopy, x-ray powder diffraction, electron microscopy, electron microprobe and electron diffraction. During the discussion that followed Dr. Langer'a 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 a high quality talc product. 5. Dr. Norwood of Charles Pfizer and Company agreed that x-ray diffrac tion would be the method of 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 chrysotlle in talc. 6. Dr. Hashed of Johnson and Johnson Introduced Dr. Loi le 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 detectingfibers in talc. If very few or no fibers are seen, electron microscopy with electron diffraction should be used. If many fibers are seen x-ray diffraction should be used. IM IM I C 4 n n n n A ^ ^ ii Page 6 7. In closing Che meeting Dr. Weissler thanked the participants and summarised the most promising approaches which might he 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 comments. 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 It ft tl Malcolm Ross, Ph.D. U. S. Geological Survey Wilson Nashed, Ph.D. . Gavin Hildlck-Smith, M.D. R. F. Rolle, Ph.D. T. B. Shelley, Ph.D. A. Goudie, Ph.D. Prof. F. D. Pooley (Consultant) W. T. Caneer (Consultant Ian M. Stewart, Ph.D. (Consultant) G. R. Grleger, Ph.D. (Consultant) Johnson & Johnson Dr. Norwood Harold D. Stanley, Jr., Ph.D. Charles Pfizer & Company tl Commr. Harold Rmer ,N.Y.C. Dept, of Air Resources S. R. Mounts 1er,' Jr. Prof. S.Z. Lewin (Consultant) Whittaker, Clark & Daniels II Paul Gross, M.D. Medical University of South Carolina Sidney Spell, Ph.D. Johns -Manville Morris Kaplan Consumers Union Norman Estrin, Ph.D. Murray Berdick, Ph.D. Cosmetic, Toiletry & Fragrance Assn. . II Herman F. Kraybill, Ph.D. Robert M. Schaffner, Ph.D. Alfred Welssler, Ph.D. John M. Gowdy, M.D. Sylvan H. Hewburger, Ph.D. John A. Wenninger Charles J. Kokoski, Ph.D. George Thompson, Ph.D. Dennis J. McGrath, M.D. J. W. Cook Hyman R. Gittep 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 I II II II II II II II II . M II . II H . II II It II cc: To all Attendees JAWenninger:vbl:9-10-71