Document RjqZD73bLJ2LRDzpaZeKexZb7

Z .J # f M p MIMERALS. PIGMENTS & METALS DIVISION RESEARCH CENTER EASTON, PENNA. RECEIVED MEMORANDUM AUG 1 3197' i ;I * V' cASTON, pa. u^i^t, 1971Subject Asbestos in Talc "Analytical Methodology nnt* a ;o, Conference at FDA, Washington, D,C,,, 3 August 1 The writers attended the above conference as representatives for Pfizer. The purpose of the conference was to discuss in detail analytical methods for the determination of minor amounts of "asbestos like" material in talc with particular reference to cosmetic grade talcs. The agenda and the list of people attending are enclosed. Individual topics were discussed by people knowledgeable in the discussion topics listed. 1, Asbestos and talc mineral deposits were discussed by Dr. Malcolm Ross of U,S, Geological Survey, The important points of his dis cussion were that: a. There are two classes of asbestos type minerals which are commonly called chrysotlle and "ampiboles"- Under the class of ampiboles are included minerals such as tremolite and anthophyllite. b. During Dr. Ross's discussion, a basic description of asbestos as it applies to this discussion was offered. "Asbestos is a fibrous fine grain mineral of theampibole or chrysotile g r o u p s ." c. Chemical mineralciogy of common talc deposits was discussed with particular reference to the New York talcs. It was rather disappointing that in no part of Dr, Ross's discussion did he mention Montana type talcs. 2. Fiber content of cosmetic talcum products was presented by Dr. L . J. Cralley. Dr. Cralley's discussion dealt with a publication he co-authored in 1968 Involving the nature and extent of respirable fibers in typical samples of talc. Sources of fibers in talc according to Dr, Cralley are two fold (the ore itself and additives used in formulation of the final product). Dr. Cralley stated that of the 22 samples he examined the majority of them contained 9 to 30% fibers. Dr, Cralley defined a fiber as having a ratio of length and to width 3 to 1 or greater. When questioned by those assembled at the meeting, it became apparent that the 9 to 3 0 % fibrous fractions were essentially 100% talc as determined by Dr- Cralley's x-ray diffraction experi ments , EXHIBIT WCD-136 CONFIDENTIAL PFI KA 00000001 MEMORANDUM Subject Asbestos in Talc "Analytical Methodology Date August 10, 1971 Conference at PDA, Washington, D.C., 3 August 1971" Dr,, Cralley presented some data concerning trace metal content of some typical commercial talcs. Again, it was rather interest ing that no Montana talcs were considered in the study. He dis cussed New York, Georgia, North Carolina, French and Italian talcs. The purpose for the trace metals analysis information at this meeting was not clear, since the objective was to discuss the methods for the determination of asbestos in talc. Several of the attendees made this point to Dr. Weissler, the moderator from FDA. 3. Biological-Medical Significance of Asbestos and Other Fibers. a. Dr, Selikoff, M t . Sinai School of Medicine, presented data showing the affects of asbestos in the formation of certaintypes of rare lung cancer, A great deal of work has been done by the M t , Sinai group involving the collection of biological medical data from a controlled group of asbestos workers dating back over the last 30 years. The results of this study give very good evidence that indeed asbestos causes certain types of lung cancer. The reason for the present emphasis being placed upon the detrimental affect of asbestos is that prior to about 1963 it was thought, as a result of clincial studies, that asbestos only caused irritation to the lung. The results of M t - Sinai studies published in 1968, shows hard evidence for presence of lung cancer directly traceable to asbestos b. Dr. G. HiIdick-Smith from Johnson & Johnson discussed his experience in the biological medical investigation of asbestos and other fibers. Dr, Hildick-Smith's main argument was that in order to properly assess the asbestos in talc problem, one must determine the total lifetime exposure from talc for the average individual. In this context he has estimated that from birth to age 70 a person would have about two month's constant exposure to cosmetic talcum powder- In addition, Dr. HildickSmith presented complete results from a study involving the occurence of cancer in hamsters. The conclusions from this study were that tremolite and/or platty talc caused no case of cancer in any of the above mentioned subjects. - 2- CONFIDENTIAL PFI KA 00000002 MEMORANDUM Subject Asbestos In Talc "Analytical Methodology Date August 10, 1971 Conference at FDA, Washington, DcC,, 3 August 1971" Dr, Hildick-Smith was the first to point out that this information was only obtained on animals and did not necessary extrapolate to humans, However, he was very adamant in his opinion that specific work has not been completed to date to clearly demonstrate affects of fiber materials on the human system He made particular comment to Dr, Selikoff's work at M t . Sinai Hospital. Co Dr. Gross of the Medical University of South Carolina, dis cussed rather briefly, certain aspects of asbestos and other fibrous materials.D r . Gross's main question to the assembly was how long do the fiber particles have to be in order to be harmful. The threshold limit value (TLV) regulation on asbestos requires that only those particles greater than 5 microns in length be counted. Dr. Gross pointed out that this TLV was set up as a expedient to testing laboratories in that 5 microns is the smallest length that can easily be measured with a light microscope. He did admit that perhaps electron microscopy counting of particles would be a much better approach for the determination of the TLV for asbestos. 4, Current FDA Interest in Asbestos, Dr, Barzilai of the FDA Bureau of Drugs, spoke very briefly on the results of a rather complete literature survey recently com pleted on the affects of asbestos and talc on humans. The main conclusions from this study were: a. There was no positive animal data showing asbestos and/or talc as the cause of cancer, b. There was no positive evidence for talc causing cancer even by the direct addition to certain body organs. In fact, talc is sometimes used as a filibrating agent in some types of complicated heart surgery - c. Inadequate physical and chemical data was collected on any of the materials reported in the literature up to 1963. Because of this it is very difficult for us to know precisely the individual minerals examined. - 3- CONFIDENTIAL PFI KA 00000003 MEMORANDUM Subject Asbestos in Talc "Analytical Methodology Date August 10, 1971 Conference at FDA, Washington, D..C\, 3 August 1971" 5. - Consumer Interest in Asbestos. Mr. Morris Kaplan, representating The Consumers Union, made a very brief statement; stressing the fact that any specification or requirements resulting from this meeting should be determined in such a manner that they eliminate any question of danger from the consumer standpoint 6. Cosmetic Industry Interest in Asbestos. Dr. Norman Estrin, representative from CTF A, gave a very brief statement expressing industry's concern in developing and supply ing safe products. At this point of the proceeds, we had progressed through 2 1/2 hours of discussion which had not touched upon its true purpose, the description of methodology for the determination of asbestos in talc.. Dr. Estrin stated this and indicated that we get down to the business at hand. 7. Analytical Methods for Asbestos-. a. Mr,. Wm. Eisenberg, from FDA, discussed the basic methods pro posed by FDA for asbestos and talc. He based his complete determination on optical microscopy and refractive index measurements. Most of these attending pointed out that many of the particles we wish to examine are smaller In size than are resolvable by light microscopy- It was felt that this determination could be used as a rough screening test on relatively coarse materials. b. Dr. Speil, from Jchns-Manvilie, in cur opinion was the high light of the meeting He was to the point and brief. He recommended the following procedures for the determination of asbestos in talc: 1. X-ray diffraction-- the ampiboles will give a 8-4 angstrom peak which is characteristic for ail of these materials. Serpentines and chrysettle give peaks at 7,0 angstrom which are again very characteristic. CONFIDENTIAL _ a_ PFI KA 00000004 MEMORANDUM Subject Asbestos in Talc "Analytical Methodology Date August 10, 1971 Conference at FDA, Washington, D ,C ,, 3 August 1971n 2, He suggested petrographic microscope observation for the determination of the fibrous nature of the specimen. Exception was taken to this idea, as indicated in Section 7a, with electron micrcscopy observation being a more practical approach. 3, A complete bulk chemical analysis The one really interesting point that Dr- Speil brought up was that instead of worrying about the bulk properties of talcum shouldn't we really be interested in air born analysis of talcs and the dusting properties of talc as determined in simulated test? c. Mr. S, R. Mountsier, Jr-, from Whittaker, Clark & Daniels, deferred his part of the discussion to Dr. Lewin, a consultant from New York University-. Dr. Levin's recommendations were that we consider x-ray diffraction as a primary test for the determination under discussion.. Dr. Lewin had measured some of the same samples that we had previously measured for Whittaker, Clark & Daniels and our results were the same. Of particular interest is the absence of fibrous minerals in MP 399 (BX-106;. d -, Dr, A, M, Langer,' frcm Mt Sinai Hospital, discussed the procedures used by them for the determination of asbestos in talc- They were: 1. Light microscope- 2. X-ray diffraction, 3 Electron microscopy. While discussing the aspects of the electron microscopy determination, Dr, Langer indicated that they had done a great deal of work by electron diffraction: However, when subsequently questioned on other points concerning electron diffraction, Dr, Langer was not clear thus raising some doubts in the minds of those attending as to the validity of their determine" ior.s e. The writers rep re sent.at ing "FILER INC , indicated that they essentially agreed with the comments made by Dr, Speil and Dr, Lewin, We indicated that PFIZER: CONFIDENTIAL PFI KA 00000005 MEMORANDUM Subject Asbestos in Talc "Analytical Methodology Date August 10, 1971 Conference at FDA, Washington, D,C., 3 August 1971" 1, Determines inineralology of the talcs by x-ray diffraction and that no ampiboles or chrysotile are detected in our Montana talcs. 2, Determines bulk chemical properties on many of the talcs used for cosmetic purposes = 3, Determines the morphology of talcs by detailed electron microscopy determinations. We demonstrated to the meeting typical electron micrographs of BX-106 Montana talc. Additionally, we showed electron micrographs of the same talc after doping with 1 % fine grain asbestos. The results of this experiment were rather dramatic and showed con clusively that at least at this level it was possible to determine asbestos accurately. It is of interest to note that none of those attending this meeting had tried an experiment as direct and as obvious as this. f. Johnson and Johnson arrived with a rather impressive group as can be seen by the list of attendees. Professor Pooley was from an environmental control agency in Wales dealing with lung diseases in miners. Dr. Gene Grieger and Dr. Ian Stuart were from McCrone Institute and are considered experts in electron microscopy techniques. Dr, Caneer was from U.S.G.S, and is considered expert, in optical microscopy and x-ray diffraction techniques. Each of the persons listed from Johnson and Johnson and their consultants described individual aspects of the asbestos in talc problem and dealt mainly with standard products from Johnson and Johnson. The methods recommended by Johnson and Johnson were x-ray diffraction coupled with electron microscopy, 8. As a result of this meeting, the following action will be taken 1, FDA will prepare a recommended procedure for the determina tion of asbestos in talc based upon the above discussion. The proposed procedure will include: CONFIDENTIAL PFI KA 00000006 MEMORANDUM Subject Asbestos in Talc "Analytical Methodology Date August 10, 1971 Conference at FDA, Washington, D C ,, 3 August 1971" a , X-ray diffraction. b , Electron microscopy - c . Electron diffraction, 2,. FDA will circulate copies of the proposed procedure to the attendees for comments and revisions. Robert E. Norwood H-P, Harold D. Stanley REN:HDS:bls Enclosures H. R. Bailey J . P. Bartels A, T. Gronet or'i , M. Grossmann C . F. Hagan M. Ho ffman/K, R. J . w. Jenkins W, E. McCoy E. G. Ratcliffe W. M. Stephenson G. A. Wells^ R. Linnett t CONFIDENTIAL PFI KA 00000007 II DIVISION OF COLORS 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, M t . Sinai School of Medicine Dr. G. Hildick-Smith, Johnson and 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 Mountsier, Jr, , Whittaker, Clark & Daniels Dr . A. M. Langer, Mt , Sinai R. E. Norwood, Cha s. Pfizer & Co. Dr . W., Washed et a l ., Johnson and Johnson CONFIDENTIAL PFI KA 00000008 DIVISION OF COLORS AND COSMETICS TECHNOLOGY FOOD AND DRUG ADMINISTRATION WASHINGTON, D,C. DISCUSSION SESSION ON "ASBESTOS AND TALC" Tuesday, August 3, 1971 - 9:30 A.M, Room 1Lo9 , Federal Building #8 200 "C" Street, S.W. Purpose: To specify a laboratory procedure for the determination of asbestos in cosmetic talcum powders which will give consistent, meaning ful results. This may require answers to such questions as: 1. Is there a need to count not only "asbestos fibers" but also "non asbestos fibers" or "fibrous talc"? 2. Is there a need to specify the variety of asbestos: tremolite, chrysotile, antho phy Hit e , etc,? 3. What particle size ranges should be reported, on the basis on bio logical effects? 4. Should the analytical results reported for "% asbestos" be based on number of particles counted or on percent by weight as estimated from particle areas? 5. Can a similar procedure be used for determining the asbestos content of a variety of foods, drugs, and other products? Format : Brief presentations (about 10 minutes each) on current work and judgments related to the problem. Emphasis on informal discussion and full exchange of information to provide a sound basis for the analytical procedure to be used, Prospective Participants: 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. L. J. Maggiori Malcolm Ross, Ph.D. M t . Sinai School of Medicine ft if U 1j.S . Geological Survey t Continued on .Next Page I CONFIDENTIAL PFI KA 00000009 iI I Wilson Nashed, Ph.D, - Johnson & Johnson Gavin Hildick-Smith, M.D. - " R. F. Rolle, Ph.D, T. H. Shelley, Ph.D. A, Goudie, Ph.D. -" Consultants: Prof, Fooley - " W. T, Caneer - " Ian Stuart, Ph.D, " Dr. Grieger - " S,, R. Mountsier, Jr. Prof. Lewin (consultant) - Whittaker, Clark & Daniels -" Paul Gross, M.D. Medical University of South Carolina Sidney Speil, Ph.D, Jchns-Manville Morris Kaplan Consumers Union Norman Estrin, Ph.D. Murray Berdick, Ph.D, Herman F. Kraybill, Ph.D. Robert M. Schaffner, Ph.D. Alfred Weissler, Ph.D, John M, Gowdy, M.D. Sylvan H. Newburger, Ph.D. John A. Wenninger Francis N. Marzulli, Ph.D. Charles J. Kokoski, Ph.D. George Thompson, Ph.D, Denis J. McGrath, M,D. Hyman R. Gittes William V. Eisenberg Richard A. Anderson Raymond E. Barzilai, M.D. Jule K. Lamar, M.D. Mrs, Manjeet Singh Armand R. Casola, Ph.D. William Cook . - Cosmetic, Toiletry, & Fragrance Association -" - Food and Drug Administration -" -" -" -" -" -" -" -" -" -" -" -" -" -" -" -" -" R. E. Norwood H. D. Stanley Ff i z* M ompany Commr. Harold Rmer Dent, of Air Resources CONFIDENTIAL PFI KA 00000010