Document x1r5Be4ZDK1855MLzYJnG1qNE

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUDLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATION W A S H IN G T O N , D .C . 20204 October 6, 1971 To: P a r tic ip a n ts in "Asbestos and Talc" Discussion Session at FDA on August 3_p 197 X Attached is a s u g a r y of om recent Discussion Sescltat on "Asbestos and Talc," As warty of yen I have requested submissions of de tailed analytical procedures frees all of the laboratories represented which perform each work. At this writing, I have received m o t , but not yet all, of the cisterial requested, Wheu the subsicsions are com plete, X shall proceed with the synthesis of these into a package which will be circulated for eor&rsants, / lliank you once again for your assistance and participation. Sittccre 1v vour& Alfred Weiss1er, Ph,B., Acting Director Division of Colors and Cosmetics Techno Office of Product Technology PLAINTIFF'S EXHIBIT WCD-4 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 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 detail 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 diffrm 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 medics! 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 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 (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 to particle in talc. 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 Ap e r t s present. list of the discussion topics is attached. GENERAL DISCUSSION I. Dr. Ross of the U.S. Geological Survey made the first presentation. Dr. Ross, a rainerologist, outlined the various associations of asbestos mineral species with talc. During this presentation and the discussion which ensued the following salient point emerged: a. Definition: Asbestos is a generic tcra for a variety of hydrated silicate minerals which have one common attribute. the ability to be separated into relatively soft, silky fiber. 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 terra "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 i chrysotile asbestos, which i 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, araosite, anthophyllite, tremolite, and actinolite. Although the amphiboles are common rock-forming minerals, the asbestofona varieties are much le$ abundant than chrysotile (1). c. The empirical formula of fclc and ora asbestofom minerals can be represented as follows: Talc, Mg3 SI4 Oxo (0H) 4 Serpentine Class Chrysotile, Mg3 Si2 O5 (GH>4 (1) Spell, S. and Lelneweber, J.P., Environmental Research 2 166-208 (1969 Pag 3 Axaphlbole Class Anthophyllite (Mg, Fe) 7 Slg 022(OH) 2 Treraolite C&2 **85 Sig 022 (OH) 2 Aetinolite Ca2 (Mg Fe) 5 Sig C>22 (0H ) 2 dc 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," Arear. In dustrial Hygiene Association Journal. 29. 350-4 (1968). The following conclusions were made in this paper; "With 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. 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. . All of the 22 talcum products analysed 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 address 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. BildickSmitk, 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 data indicates that there is no health hazard associated with the use of cosmetic grade talc. It war also pointed out*that talc introduced surgically does not appar ently cause mesotheliomas. c. Br. Gross of the Medical University of South Carolina reported that there is very little if any data on the effects of talc in Plan or animal. Intratracheal injection of talc in hamsters caused no ill effects. In these animals no lung scarring was scon. Asbestos particles less than 5 microns in length reportedly do not cause lung damage. This point, however, has not been definitely confirmed. 4. Dr. Ersybill 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, Barzil&i of the Bureau of Drugs reported that particulate matter in drug products af@ 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 th subject of asbestos and talc would be resolved in the interest of the consumer rather than in the interest of the producer. 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. Sis 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 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. Speil felt, however, that the important question to be answered is: Eov much 'gets into the lung of the person who is exposed? He suggested that a model be eet 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 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. Danger and Dr. Maggiore of Mount'Sinai reported that they use the following techniques to detect and determine asbestoform miner &ls; light microscopy, x-ray powder diffraction, electron microsco electron microprobe 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 a high quality talc product. 5. Dr. Norwood of Charles Pfizer and Company agreed that x-ray dlffra ties would be the method of choice for the analysis of asbestos ir talc. He indicated that by using step scanning and other sophist! techniques you could probably detect down to 0 .17 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. Rolle recommended that optical microscopy be used as a first step in detecting fibers in talc. If very few or no fibers ore 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 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: Lewie J. Crailey, Ph.D. National Institute of Occupational Safety and Health, Cincinnati, Ohi Irving J. Selikoff, M.D. Arthur M. Langer, Ph.D. William J. Nicholson, Ph.D. C. J. Haggiore, Ph.D. Mt. Sinai School of Medicine it it h Malcolm Rees, Ph.D. U. S. Geological Survey Wilsoa Hashed, Ph.D. Gavin Kildick-Sinith, M.D. R. P. Rolls, Ph.D. T. H. Shelley, Ph.D. A. Goudie, Ph.D. Prof. F. B. Pooley (Consultant) W. . Caneer (Consultant Ian M. Stewart, Ph.D. (Consultant) G. R. Grieger, Ph.D. (Consultant) Johnson & Johnson h h It II It II If It Dr. Norwood Harold B. Stanley, Jr., Ph.D. Charles Pfizer & Company it Commr. Harold Roraer ,N.Y.C. Dept, of Air Resources S. R. Mounts1er, Jr. Prof. S.Z. Lewin (Consultant) Whittaker, Clark A Daniels tt Paul Gross, M.D. Medical University of South Carol Sidney Spell, Ph.D. Johns-Manvilie Morris Kaplan H o m a n Estrin, Ph.D. Murray Berdick, Ph.D. Consumers Union Cosmetic, Toiletry A Fragrance A6 " Herman F. Kraybill, Ph.D. Robert M. Schaffner, Ph.D. Alfred Weissler, Ph.D. John M. Gewdy, M-D. Sylvan H. Hewburger, Ph.D. John A. Wenninger Charles J. Kokoski, Ph.D. George Thompson, Ph.D. Dennis J. McGrath, M.B. J. W. Cook Hyman R. Gittes William V. Barailal, M.B. J'tile K. Lamar, M.D. Mrs. Manjeet Singh Armand R. Casola, Ph.D. M. A. Weinberger, M.B. Paul E. CoraeliuBsem K. S. Heine Albert C. Kolbye, M.D. Page 7 Food and Drug Adndnifitration tl n h It It 91 01 If II It t! II tl ft tl If (b) (5) 4ETH0D :i.cal . :roscopy FIBER ANALYSIS QUAL. QUANT. Yes Presence and ' Kind of Fiber Yes Point and Area Count MINIMUM PARTICLE SIZE DETECTABLE r*' 0 .5/s~ LOWER LIMIT OF DETECTABILITY TIME FOR QUANTITATF ANALYSIS Not Applicable ' 1/2 Day mning ctron :roscopy Presence of Fiber Yes Point and Area Count ^ 0 .lyLA. Not Applicable One Day ictron ;roscopy fcay :fraction Yes Presence and Kind of Fiber Kind of Fiber Yes Point and Area Count 0.01^- Not Applicable Yes (wt/wt) Minimum Particle 0.5% Size for Diffraction w is ca. 0.1/jl/~ More Favorable Cases One Day Two Hours to a Day Depending on Methoc From; R* F. Rolls, Ph.D. Johnson and Johnson Research Division New Brunswick, N.J. C8903 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'-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 Manville S. R liountsier, Jr., Whittaker, Clark & Dr. A. M. Langer, Mt. Sinai Dr. Norwood, Chas. Pfizer & Company Dr. W. Hashed et al., Johnson & Johnson