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FILE NAME Talc TALC DATE 1971-1975 DOC TALC301 DOCUMENT DESCRIPTION Barry Castleman Letters & Communications Johnson DOMESTIC OperatiNG COMPANY NEW BRUNSWICK N. J. August 2 1971 Mr. Barry Castleman Department of Environmental Engineering Hopkins University Baltimore Maryland 21201 Dear Mr. Castleman This is in answer to your letter of July 25 1 The use of talc as a cosmetic extends far back in historical time More specifically Johnson & Johnson has marketed baby powder since 1895 2 We have no asbestos in our baby powder To prove this we have had extensive analytical work carried out by mineralogists at the Colorado School of Mines by McCrone Laboratories in Chicago and by Professor Fred Pooley at the University of Wales in Cardiff Professor Pooley is associated with one of the teaching scientific groups studying the relationship of asbestos and other inorganic particles to cancer 3 We have no meaningful information regarding baby powder manufactured by other companies We suspect however that the 5 to 25 percent quotebdy the newspapers is not based on carefully documented scientific evidence I hope the above answers your questions Sincerely Thomas H. Director Shelley Ph D Central Research Laboratories i Mr. Barry Castleman August 2 1971 . L. Mr. G. Foster + bhen wate w The attached is I believe explanatory I obtained the 1895 data from Bill Ashton oe If you agree please send it out rethink T. H. Shelley , 3 7 . cc Dr. G. Hildick . { @--.0.0 5 mo, Dr. W. Nashed Talc File - 503 res a oo aa _ Protected Document to Protective Order . . . JNJNL61_000024920 JNJNL61_000024920 me Peta cae August 1971 SOT enon OE een ' E1. lve E vyve BR le T et. ae 3d Td cdbse bi nate bd Mr. Earry Castleman Department of Environmental Engineering J.hns Hopkins University Baltimore Maryland 21201 Dear Mr. Castleman This is in answer to your letter of July 25 1 The use of talc as a cosmetic extends far back in historical time More specifically Johnson & Johnson has marketed baby powder since 1895 2 We have no asbestos in our baby powder To prove this we . have had extensive analytical work carried out by mineralogists at the Colorado School of Mines by McCrone Laboratories in Chicago and by Professor Fred Pooley at the University of Wales in Cardiff Professor Pooley is associated with one of the teaching scientific groups studying the relationship of asbestos and other inorganic particles to cancer 3 ' We have no meaningful information regarding baby powder manufactured by other companies We suspect however that the 5 to 25 percent quoted by the newspapers is not based on carefully documented scientific evidence I hope the above answers your questions 4 Sincerely @ bcc Mr. L. G. Foster Dr. G. Hildick Dr. W. Nashed Protected Document to Protective of File - 503 Thomas H. Shelley Ph.D Director Central Research Laboratorics . JNJNL61 000024921 FILE NAME Johnson & Johnson JAJ DATE 1971 Aug 3 DOC JAJ105 DOCUMENT DESCRIPTION FDA Meeting Summary - Asbestos and Talc _ MEMORANDUM OF A SYMPOSIUM. August 3 1971 PLAINTIFF'S PLAINTIFF'S EXHIBIT JNJ ASBES ANT D TOALSC 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 health hazards associated with their interest but differing reports presence products and the inhalation are subjects of current At & 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 laboratory procedure for the analysis of asbestos in talcum will give consistent meaningful results details powders of a which 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 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 asbestos and talc ore deposits and other fibers and the mineralogy of INTRODUCTION Dr. Weissler opened the meeting by outlining some of the events which had brought the question of asbestos particles in tale 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 o tonsJupnaerti2c8le1s97i1n tthaelcFDA was taking steps to investigate investigate the problem of asbes- JNJNL61_000001139 JNJNL61_000001139 cage 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 products upon FDA would be in a position to determine if such contain asbestos fibers on the market 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 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 95 of the asbestos fiber produced today There are five recognized asbestoform varieties of amphibole crocidolite amosite anthophyllite tremolite and actinolite . Although the amphiboles are common forming minerals the | asbestoform varieties are much less abundant than chrysotile 1 c The empirical formula of talc and some asbestoform minerals can be represented as follows 0 Talc Mg3 S14 010 Serpentine Class Chrysotile M83 S12 05 OH 1 Speil S. and Leineweber J.P. Environmental Research 2 166-208 1969 JNJNL61 000001140 Page 3 Amphibole Class Anthophyllite Mg Fe Sig 022 OH 2 Tremolite Ca2 Mg5 Sig 022 OH ~ Actinolite Ca2 Mg Fe Sig 022 OH 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 Instituftoer Occupational Safety and Health spoke on the fibrous content of cosmetic talcum products His presentation centered in part on a paper he authored entitled Fibrous and Mineral Content of Cosmetic Talcum Products Amer 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 sales in the industry or to what extent the sourceosf the talc in these lations are the same as sources of talc four formu- specified for use in other talcum products in the competitive market The levels of silica chrom andiniu ckm el 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 probably contained minor amounts of tremolite anthophyllite 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 meaninogf the presence of these ferruginous bodies however is uncertain 3 The third discussion topic on the program dealt medical significance of asbestos and other fibers themselvetso this topic with the biological and Three speakers addressed a Dr. Selikoff of Mount Sinai School of Medicine outlined briefly the history of fibrosis in asbestos workers which has been known to years ago when officials was medical profession for over 30 he met with FDA years He reported that a few there no apparent JNJNL61_000001141 JNJNL61_0 0 01 41 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 possibility that lung cancer may result even from exposures at less than occupation levels b Dr. Hildick Director of Clinical Researc fohr Johnson and Johnson & outlined briefly the medical aspects of talc production and uses He reported that & has been in the talc business for over 70 years Talc along with a whole host of other materials can give risteo a biological response & has not noted any adverse effects from the use of talc in either their employees or reported in the literature Talc manufactured by & is highly refined to produce a . platy talc Available data indicates that there is no health hazard associated with the use of cosmetic grade It was also pointed out that talc introduced surgically does not apparently 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. 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 tale would be resolved in the interest of the consumer rather than in the interest of theproducer JNJNL61_000001142 JNJNL61_000001142 Page 5 6. Dr. Estrin of the Cosmetics Toiletry and Fragrance that the Association was ready to join with FDA and the to determine if there is a consumer safety problem with Association reported academic community 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 asbestoform minerals in talc Dr. Speil of Johns Manville Research Center reported that tremolite and chrysotile could be determined in talc at a level of about 0.5 by ray diffraction Dr. Speil 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 Dr. Lewin a consultant for Whittaker Clark and Daniels reported that 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 Dr. Langer and Dr. Maggiore of Mount Sinai reported that they use the following techniques to detect and determine asbestoform minerals light microscopy ray powder diffraction electron microscopy electron microprobe and electron diffraction During the discussion that followed Dr. Langer's presentation he was asked if he had analyzed a sample referred to as 344 from Johnson and Johnson He said that he had and that it was a high quality talc He added that all the talc producer's represented at the meeting produced a high quality tale product Dr. Norwood of Charles Pfizer and Company agreed that ray diffrac- tion would be the method 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 chrysotile in= talc . ; 6 Dr. Nashed 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 are seen electron microscopy with electron diffraction should be used If many fibers are seen ray diffraction should be used INI 61 00000144 00000144 Page6 7. In closing the meeting Dr. Weissler thanked the participants and summarized 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 and these will be synthesized by FDA and circulated for comments 7 ! Wenningu a John A. Wenninger Assistant Chief Cosmetics Branch Division of Colors & Cosmetics Technology The following people attended the symposium LewiJs. 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 11 Malcolm Ross Ph.D. Wilson Nashed Ph.D. Gavin Hildick M.D. R. F. Rolle Ph.D. T. H. Shelley Ph.D. A. Goudie Ph.D. Prof. F. D. Pooley Consultant W. T. Caneer Consultant Ian M. Stewart Ph.D. Consultant G. R. Grieger Ph.D. Consultant S. Geological Survey Johnson & Johnson " - Dr. Norwood HarolDd. Stanley Jr. Ph.D. Commr Harold Romer Charles Pfizer & Company " N.Y.C. Dept. of Air Resources S. R. MountsieJrr. Prof. S.Z. Lewin Consultant Whittaker Clark & Daniels " . Paul Gross M.D. Sidney Speil Ph.D. Medical University of South Carolina Manville Morris Kaplan Consumers Union Norman Estrin Ph.D. Murray Berdick Ph.D. Cosmetic Toiletry & Fragrance Assn . 7] IN IN CA Amann ss 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 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. 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. Kolby~ M.D. " Page 7 Food and Drug Administration " = = = cc To all Attendees JAWenninger 9-10-71 IN IN CA Amana s a ati suateatd p < FE ae CORT eS tid bia di Me . >e ' . JUL 1971 RECEIVED RECEIVED RECIVED RECEIVED RECEIVED CONS & PROF SERVICE . Deps Deps line Deps of of Exercentile Expensesing Exercentile Expensesing Julins Julins Mystion Mystion Julins Mystion Mystion Mystion Julins Mystion Julins CluCsluvsveerrsistyity Clusversity Clusversity Clusversity ClusverCsluisvetrsyity Baltimore Baltimore i q - j ... ... ... ... ... ... ... 6... ... .../. Jahunan Jahunan Jahunan Jahu nanJahunan July NewNew Brunswick New JerseJyersey P am perisiatly finishing @ c oo soni! es health effects asbestos asbestos asbestos asbestos of caolfls from current for pounders removal there are several assessing the justificationjustificationjustification asbestos asbestos toleum toleum things things lavish to know Johnson's been plant 4 : long Johnson's Johnson's soudersouder in widopane widopane widopane nipuli nipuli ae. in removingtheasbestos fiber from proces tails in which believe itnaturally occurs ? 3 Do all talcumpowders contain contain asbestos and among among those which is what is the range of tion platecontent @ information Anyinformation you 4 Protected Document to Protective Order can can will greatly provide provide greatly appreciatial , SincerelySincerely Sincerely Sincerely Sincerely Clamu Sincerely Babour Co. BabourBabour Clamu Clamu na appreciatial appreciatial JNJ 000682902 FILE NAME Johnson & Johnson JAJ DATE 1971 July 28 DOC JAJ089 DOCUMENT DESCRIPTION Memo RE Barry Castleman Letter Requesting Asbestos Health Information 4 @ r 3 tone Ws abet tere tet Beak Dpmbsebes rn tari: Johnson New Brunswick N.J. July 28 1971 Subject Asbestos Inquiry-- Mr. Barry Castleman RECEIVED Dr. T. H. Shelley JUL 1971 T.H. SHELLE Jack Walcott has asked me to Barry Castleman to you Mr. Environmental Engineering at direct the attached letter from Castleman is in the Department of Johns Hopkins University From the tone of this letter it seems clear that Mr. Castleman has scientific knowledge far beyond the normal type of inquiry we have received from the public The inquiry appears to require a more scientific response than we have been using in handling consumer correspondence Therefore we believe that this in & letter should be handled by someone Before the with Larry response Foster is sent to Mr. Castleman it should be checked Thanks very much for your help GFT 1m Attachment CC Mr. J. T. Dettre Mr. L. G. Foster Dr. R. A. Fuller Mr. R. J. Howland Mrs. D. Matsu Mr. J. C. Walcott he ah ste ia nati oe ne Te ve } Protected Document to Protective Order G. F. Tyrrell JNJ 000682901 DEPARTMENT OF HEALTH EDUCATION PUBLIC HEALTH SERVICE AND WELFARE FOOD AND DRUG ADMINISTRATION WASHINGTON D.C. 20204 April 6 1972 Mr. Barry I. Castleman Division of Air Pollution and Industrial Hygiene Bureau of Environmental Services Baltimore County Department of Health Maryland Avenue and Hillen Road Towson Maryland 21204 Dear Mr. Castleman Your inquiry of March 22 1972 been referred to me for reply to Dr. John Palmer concerning asbestos has chemical y The Food and Drug Administration is aware of the asbestos problem and we have been studying it intensively for the past year There is some difficulty in identifying asbestos in talc since they are chemically the same and much of our effort has been directed to the development of methods for the analysis of talcum powders for the presence of this We now have several methods which we are preparing to contaminant apply to commercially available talcs We do not anticipate that the of talc will be any- air levels of asbestos fibers incident to the use where near the tolerance level established for industrial exposure see attached FR statement of January 12th but are planning research to determine this point A proposal has been published except in those circumstances fireproofing A copy of this to ban asbestos coats and other garments where asbestos clothing is necessary for proposal is also enclosed February 18th materials as such do not come directly within the purview of Building is prepared to the Food Drug and Cosmetic Act If no other agency deal with this problem it is possible that the Hazardous Substances could be stretched to cover it however we would require advice Act action in this area from our General Counsel before attempting any 2 In addition to the above problems we are are also of asbestos fibers in liquid and significance investigating the incidence drugs and beverages I hope this is the information you desire Sincerely yours M. Youdy John Assistant Director for Medical \ Division of Colors & Cosmetics Office of Product Technology Review Technology Enclosures April 13 1972 Division of Colors and Cosmetics Office of Product Technology Food and Drug Administration Washington D.C. 20204 Technology Attention Dr. John M. Gowdy Assistant Director for Medical Review Dear Dr. Gowdy I am writing in reply to your letter of April 6 about the FDA's studies on tale and asbestes containing products It is apparent that no epidemiological or toxicological studies are being performed by FDA on tales without asbestos It also appears that although the FDA could probably require labeling of containing products such as building materials sold to homeowners in hardware stores under the Hazardous Substances Act this course is not being actively pursued I don't know of another U.S. government agency which has responsibility for requiring labeling of hazardous substances on the consumer market or banning the use of hazardous products I am concerned about the availability of unlabeled asbestos products to the public I am also disturbed about the use of talc a suspected carcinogen as a major constituent in cosmetic powders and perfumed vaginal sprays its use in dusting surgical gloves has been discontinued The National Institute for Occupational Safety and Health has recommended that asbestos containing materials used industrially bear a hazard label in Criteria for a Recommended Standard . Occupational Exposure to Asbestos February 1972 It is possible that in adopting a new standard for occupational exposure to asbestos the Labor Department will require the labeling of containing products used by the labor force Nonetheless even if the Labor Department requires labeling of some asbestos products the problem of labeling other asbestos products on the consumer market will remain The problem of evaluating the hazards of specific products in the light or darkness of present knowledge and then deciding if these products should be withdrawn from the market yourself home boiler insulation of asbestos tale vaginal aprays asbestos filters in processing foods and drugs asbestos binder in cigars etc. - will remain Correct a ee Food and ru Administration April 13 1972 Page twe ne if am vrone Aduluistration Aduluistration but Ion't this the responsibility of the Food andTUE BIC cnu Very trul vours BDC Barry T. Castleman Technical Services Sectioa Mvision of Air Pollution and Industrial tiene Bureau of Environmental Services CC Senator Charles M. Mathias Representative Paul S. Sarbanes the cancer experience --,-- --"--, --,-- e--x"p--o,sed ) other studies ofworketordaste Dr. what needed neded are records of : Causes either Can you help me to locate from your compacompanny's ryeco'rdss study or from Reports of take particleisn tissue J. Obstet Gynecol 78 1971 and excess j they provide mo --,--"-- -- talc hazard hazard Barry I Castleman DOMESTIC OPERATING COMPANY NEW BRUNSWICK N. J. August 10 1972 Mr. Barry I. Castleman 305 West Biddle Street Baltimore Maryland 21201 Dear Mr. Castleman This is in reply to your letter of August 3. Since the information you request is largely medical in nature I have forwarded it to Dr. Hildick Director of Clinical Research Dr. Hildick is presently on vacation but am certain he will write to you shortly after his return mf CC Dr. G. Hildick Sincerely ---- ---- ---- -- T. ---- ---- ---- ---- -- ---- ------------------ -- Director Central Research Laboratories ~ Johnson Johnson Subject Mr. Barry Castleman's re Asbestos letter TF TF New Brunswick N.J. August 10 1972 aR Dr. G. Hildick ew cae rotah aide, Aw oe The attached re info on talc toxicity is self explanatory I a really think this demands a medical answer and would appre- cnarte ciate your handling > mf att CC Mr. J. T. Dettre Mr. L. G. Foster Dr. R. A. Fuller Mr. R. F. Kniffin Mrs. D. Matsu Dr. W. Nashed Mr. R. C. Stites Tor T. H. S. RECEIVED AUG 11 1972 W. NASHED JOHNSON & JOHNSON Protected Document to Protective Order 1 of 1 JNJ 000261178 Pltf_JNJ_00038491 Pltf_JNJ_00038491 _ CHARLES MCC MATHIAS JR MARYLAND Vlnited States Senate WASHINGTON D.C. 20510 June 15 1972 REPLY TO 1616 FEDERAL BUILDING 31 HOPKINS PLAZA BALTIMORE MARYLAND -962-4850 21201 Mr. Barry I. Castleman Technical Services Section Division of Air Pollution and Industrial Hygiene Bureau of Environmental Services Baltimore County Department of Health Maryland Avenue and Hillen Road Towson Maryland 21204 Dear Mr. Castleman Please find enclosed a copy of a letter I have received from the Department of Health Education and Welfare relative to containing products I hope the help to clarify to the Food and information provided in Mr. Meyer's letter will some of the points you raised in your correspondence Drug Administration in regard to this matter I was happy to have had an opportunity to be of assistance to you With best wishes Sincerely __ esg Enclosure Charles McC Mathias Mathias Jr. United States Senator / DEPARTMENT OF HEALTH EDUCATION AND PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION ROCKVILLE MARYLAND 20852 WELFARE JUN 7 1972 Honorable Charles McC Mathias Jr. United States Senator Suite 1616 Federal Building 31 Hopkins Plaza Baltimore Maryland 21201 Dear Senator Mathias This is in further reply to your letter of containing products April 20 concerning The Food and Drug Administration is the presence of asbestos aware of the recent concern over food products particles in talc which may be used in Since there is some difficulty in of their chemical similarity we identifying are asbestos in talc because the available analytic procedures now for in the process of evaluating talc However in the meantime determination of asbestos in products containing talc with we are moving ahead with analysis of of asbestos particles of exposure by the existing methodology for the We are attempting to determine thperedseegnrceee substances We average consumer to products containing these are also preparing a draft for a praegrutliactlieosn for the use in foods of talc which is fprreoepoosefdapsrobveissiotno als Funds for animal studies on the not been available A toxicological effects of talc have justify the needed memorandum of need is being developed to including talc funds for contract feeding studies on silicates The Bureau of Product Safety of the Food and reviewed the NIOSH document Criteria for Drug Administration has Occupational Exposure to Asbestos and a the Recommended Standard Castleman gave from page V We are quotation Mr. Castleman unaware of any type of asbestos product rise to such concentrations of airborne overwhelm the clearing mechanism fibers that its use would Since term exposure to levels contemplated by the standard would not be clearing mechanism the level expected to overwhelm the must be much higher contemplated by the quoted passage Page 2 - Honorable Charles McC Mathias Jr. a FDA has at the present time no specific regulatory actions except the prohibition of use of asbestos as underway use garments a component of general We are continuing to explore the possibility of hazard from other uses of asbestos containing products in the home and methods for control of such hazards as are our consideration labeling construction discovered including in and if it should become criteria such as bonding products to control likenleicheososdaroyf braenlneaisneg osfpecaiifribcornaes yfeitberusnidofentified asbestos Thank you for your interest further assistance Please let us know if we can be of Sincerely yours Enclosure Constituent's letter Gerald F. Meyer Director Office of Legislative Services CC Your Washington Office Johnson March 7 1972 NEW BRUNSWICK N. J. Mr. Barry Castleman 305 W. Biddle Street Baltimore Maryland 21201 Dear Mr. Castleman First I must apologize for the delay in replying to your inquiry about JOHNSON'S Brand Baby Powder Your card was sent in office mail with some correspondence in usable envelope The other mail was taken from the envelope which was then placed in a stack to be used again used again until this week and your Unfortunately it was not card was discovered at that time To answer your question Johnson & Johnson takes great care in the formulation and production of all its products In the case of JOHNSON'S Baby Powder the talc comes from our own mines specifically selected for the quality of their talc This grade talc is processed through repeated washings in order to free it of impurities Under careful analysis by independent experts the finished product has been shown to be free of asbestos . Thank you for please forgive your interest in Johnson & Johnson the delay in replying to your card products and Sincerely SS Steven Sawchuk M.D. Associate Director of Clinical Research March 22 1972 Food and Drug Administration Department of Health Education 5600 Fishers Lane Rockville Maryland 20852 and Welfare Attention Mr. John P. Palmer Bureau of Drugs M.D. Deputy Director Dear Dr. Palmer I am writing to find out what the FDA is doing to research the suspected carcinogenicity of talcs with and without tremolite asbestos ; and what measures are being taken to safeguard the public against exposure to containing consumer products building materials fabrics etc. As you and Health has Standard ..... probably know the National Institute for Occupational Safety just published the document Criteria for a Recommended Occupational Exposure to Asbestos The closing remark in section V Development of Standard reads Thus the affect after several decades of a time acute dose of limited duration which overwhelms the clearing mechanism and is retained in the lungs may be as harmful carcin- ogenic as the cumulative effect of lower daily years of work Asbestos is known to have been including filter media for production of drugs doses of exposure over many used in over 3000 applications cheap cigars hone holler cheap products insulation resistant clothing paper sprayed fireproofing ~s insulation and numerous building products ; Talc is mineralogically similar to asbestos and in a survey of 51 commercial tales in 1942 17 were found to have greater than trace amounts of tremolite asbestos which frequently occurs combined with talc deposits Recent publications have pointed out the possibility of tale causing ovarian cancer and stomach cancer in Japan However as far as I know no one has been able to firmly establish talc as being either carcinogenic or harmless The most disturbing use of talc I know as is in recently f^'minine hygiene sprays Also some cosmetic powders have strikingly high fibrous content content Any information you can send about the FDA's activities on asbestos and tale will be deeply appreciated ce BIC cms Pr Earl Meyers Mr. Jerome Goldstein Sincerely youre ; Hh at etl Pin spe Cos TE owe Barry Le Castleman Division of Air Pollution and Industrial Hygiene Bureau of Environmental Services DEPARTMENT OF HEALTH EDUCATION PUBLIC HEALTH SERVICE AND FOOD AND DRUG ADMINISTRATION WASHINGTON DC 20204 WELFARE May 2 1972 ed oe Spermech Nt Mr. Barry Castleman Technical Services Section RT Division of Air Pollution and te i a Industrial Hygiene ee Bureau of Environmental Services oe of Health alg Baltimore County Department ea Maryland Avenue and Hillen Towson Maryland 21204 Road care Dear Mr. Castleman Thank you for your letter of April 25 1972 and the enclosed material six months various members of the Food and Drug During the past with Dr. Selikoff have had a number of conferences Administration collected and reviewed about staff here and in New York We have hundred papers on asbestos toxicity and one his of the long time lag and also because of a reluctance the dose response Largely because to a potentially toxic substance to allow human exposure of asbestos toxicity are undetermined The industrial be 20 to 40 relationships rather shaky ground however it will tolerance rests on it is too high or too low before it can be determined whether years tremolite because it is not widely used does not have have talked with In the meantime of injury as does chrysotile I the background proven is less hazardous than other forms who feel that tremolite some experts be settled by argument of asbestos This point can not and Cosmetic Act which governs With regard to cosmetics the Food Drug that products must be shown to contain i.e. our activities states precisely to action substance before they are subject a harmful or deleterious is hazardous before it can The FDA must be prepared to prove a cosmetic act against it Condoms and Henderson diaphragms are dusted with W. J. C. A. F. Joslin A. talc Henderson et al C. Turnbull and K. Griffiths 5 y ore Page 2 - Mr. Barry Castleman abte Talc and 266 - carcinoma of the ovary and cervix J. Obstet Gynecol Br Commonw 272 March 1971 were able to demonstrate talc but not asbestos within malignant tissue Unfortunately they also noted talc es particles in normal tissue ee wr I would very much like to see the results of a survey such as you discuss There may be a problem in that women who do not use talc dusted contraceptives may have been examined with tatc dusted gloves so that there may be some problem in developing a control group Sincerely yours Alacer. M John John M. Gowdy Youdy M.D. Youdy . Assistant Director for Medical Division of Colors & Cosmetics Office of Product Technology Affairs Technology VI Phone Number 301-494-3775 May 10 1972 Dr. Albert Fritsch Center for Science in the Public 1346 Connecticut Avenue N.W. Washington D.C. Interest Dear Mr. Fritsch I was referred to you by Ken Lasson I am interested in research on the adverse effects on health of asbestos and tale in particular carcinogenisis Ken said that your center performs oriented investigations and you might be working on these topics now As far as I know no one has yet demonstrated that occupational environmental exposures to talc carry an excess risk of developing cancer This has been done for asbestos and the government has begun to effect restrictions on its use However the striking chemical similarity between talc and asbestos the occurrence of greater than trace amounts of tremolite asbestos in talcum powders and the knowledge that - occupational exposure to talc carries an excess risk of lung cancer are disturbing in view of the widespread use of talc in infant and very cosmetic powders perfumed vaginal sprays etc. My correspondence with FDA indicates that they are doing a minimal job analyzing talcs for asbestos about regulating both asbestos and tale in consumer goods I would like to know of ways to get them interested In my spare hours here 7 have reviewed some of the literature on cervical cancer epidemiology I also understand that some but not all are dusted with talc in processing and packaging Dr. Abraham pLriolpiheynlfaecltdicast the Johns Hopkins School of Hygiene has an interest in talc also and I hope to work out some kind of study with him soon Please let me asbestos and tale I it worthwhile know your interest and activities in the subjects of would be glad to come down see you if you think My best wishes in your work Sincerely dh Barry Castleman Technical Services Section Division of Air Pollution and Industrial Hygiene Bureau of Environmental Services 202 833-3721 CENTER FOR SCIENCE IN THE PUBLIC INTEREST 1346 Connecticut Avenue N.W. Room 812 Washington D.C. 20036 Barry Castleman Technical Services Section Division of Air Pollution & Industrial Hygiene Bureau of Environmental Services Baltimore Co Dept. of Health Towson MD 21204 May 15 1972 Dear Barry Thanks for writing and showing your interest in the talc and asbestos question since our There is no reason why type of public interest we can't cooperate on a project in work is so entirely different from the full what you anticipate doing We hope to have a program started in the fall on checking consumer items containing asbestos and talc and finding which ones are most dangerous We have a partial list of the 3000 or more items and I am hoping that Consumer's Union which is funding us on be willing to give us 10,000 for the coming year other chemicals will I program would where like to get together with you people and plot a we deliver items which are highly dangerous and cooperative you would test them to see how friable they really are We could then carry on the work we are doing now of alerting the FDA EPA etc through letters petitions and lawsuits if necessary we would eventually write a map of consumer items made from asbestos and talc and give this to Consumer's Union and other consumer groups to generate citizen pressure for regulations We asked the NIH to endorse our proposal They simply couldn't believe that scientists would work at sustenance wages and said the project was good but the funding about all the CU can afford was unrealistic If you folks would show an interest in a cooperative venture and be willing to do analysis it would fortify our project If you are so moved please send a note to the following Mr. David Swankin Consumers Union National Press Bldg Wash DC 20004 works uses You are right in with Sellikoff's I think the FDA suspecting that the talcs are bad Art Langer who group at Mt. Sinai is very concerned about their many will have to be shaken from their complacency and made to start some systematic action on these commodities Let's get together and talk about these problems talc and asbestos My schedule is very tight for the next 5 or 6 weeks three talks and the Environ- mental I have Forum a few in Europe free days plus next seeing some public interest week and will be back after centers in June 22 Europe Sincerely yours Albert J. Fritsch VI May 15 1972 Mr. Paul S. Sarbanes Congress of the United States House of Representatives Washington D.C. 20515 Dear Mr. Mr. Sarbanes the and Enclosed is my continued correspondence with Food and Drug Administration on the subject of containing consumer goods ; John Gowdy of regulation of asbestos- One thing is clear to me at this point the FDA unwilling to take regulatory action and I don't think await another 40 years of mortality studies to know the ; to which the public is now being exposed is either we should degree of unable or have to hasard * to Mr. Sarbanes I urge you to use your influence see that something is done about this situation Of course I will be glad to discuss it at length with you or members of your staff at your convenience Sincerely Barry Gentleman Technical Services Section Division of Air Pollution and Industrial Hygiene Bureau of Environmental Services 30 Encl Johnson NEW BRUNSWICK N. J. 08903 September 19 1972 Mr. Barry I. Castleman 305 West Biddle Street Baltimore Maryland 21201 Dear Mr. Castleman I am taking the liberty of replying replying to your letter dated August 3 addressed to Dr. T. H. Shelley , Director of our Central Research Laboratories First let me express our appreciation of your bringing to our attention attention your concern about the possibility that talc by itself may be carcinogen As we market talc we have real concern about any potential harmful effects it may have and have been monitoring monitoring on a continuing basis the world literature on the biological biological activity of talc We are primarily interested in determining whether the cosmetic use of talc can cause any harmful effects effects and at this time have no reason to believe that tale alone will induce neoplastic changes The publication by Kleinfeld Arch Arch Exper Health 14 663-7 1967 that you mentioned in your letter is familiar to us and as you know reports on the incidence incidence of pulmonary cancer in miners working in talc mines which contained contained tremolite and serpentine position am submitting some points which support our may Py; that pure talc is not a carcinogen which be of interest to you 1. The monitoring of adverse effects effects relating to the commercial use of a product product that has been marketed for over 70 years by us and used cosmetically for centuries 20 The continuing review of the world literature on talc shows that it has been used used therapeutically when introduced into the pleural pleural cavity has been J Mr. Barry I. Castleman -2- September 19 1972 } introduced into the peritoneal cavity from ruptured surgical gloves and has been respired by industrial workers In both the pleural cavity and the peritoneal cavity talc produces local fibrosis in the tissues and to date we have not been able to find any reports reports of cancer in the extensive medical literature on this subject Excessive exposure to talc causes talcosis in miners and I know of no data to indicate that cancer of the lung occurs in to talc free of asbestos * such miners exposed 3 Controlled studies have been conducted in hamsters in which talc was introduced into lungs and pleura and the results showed no cancer development when the animals were followed for their life These data were in contrast to results obtained when asbestos was these studies literature used in place talc A paper on will shortly be reported in the medical 4 order to confirm the findings reported in 3 two separate extensive animal studies are being conducted independently in which the animals will inhale talc for different time perio and will be followed for their lifetime and then examined histologically Your comment concerning the follow up of talc miners to determine the cause of their death is pertinent but is time consuming and the numbers involved are relatively small However in order to obtain epidemiological data more rapidly we are currently following an extensive epidemiological survey of the cause of death in large group of industrial workers expose to talc with a view to determining whether they differ from other appropriate populations In addition we are attempting to obtain data on the cause of death of Van Orstrand July 1970 H.D Talc pneumoconiosis Chest 58 Mr. Barry I. Castleman -3- September 19 1972 talc miners and determine if the cause of death differs from other populations am hopeful that the comments assistance to you I have submitted will be of We appreciate your interest in writing to us and forward to supplying you with pertinent published data as available look they become MMS Sincerely yours A "4 py \ 4 Aldi up ; >} a Ae Clinical Gavin Hildick Director F.A.A. of Clinical Research ENVIRONMENTAL DEFENSE : FUND 1276 | 1525 18th XXXXXN STREET N.W. WASHINGTON D.C. 20036/202 833-1485 December 19 1973 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fishers Lane Rockville Maryland 20852 Comments on the Food and Drug Administration proposed tion Asbestos Particles and Drugs 38 Fed Sept. 28 1973 Reg regula- in Food 27076-81 % Dear Sir We attach the comments of the Environmental Defense Fund | and the Center for Science in the Public Interest concerning the 1 proposed regulation cited above CSPI is a Washington profit corporation composed of scientists dedicated to public interest research and advocacy on public health and environmental issues EDF isa profit public benefit corporation organized under the New York State law with a nationwide membership of approximately 45,000 indi- viduals - CSPI and EDF had earlier petitioned FDA to promulgate a regulation prohibiting the use of materials or procedures in the manufacture of food and drugs which would result in the addition of asbestos to food or drugs In the following comment: we discuss the adequacy of the resultant proposal by FDA Respectfully submitted 7 Lucile F. Adamson Ph.D. Environmental Defense Fund Barry Castleman Barry Castleman Center for Science in the Public . Enclosure Interest OFFICES IN EAST SETAUKET NY MAIN OFFICE NEW YORK CITY PROGRAM SUPPORT OFFICE WASHINGTON DC BERKELEY CALIF This paper is recycled to protect the environment . JNJNL61_002535 JNJNL61_000022535 JNJNL61_000022535 202 332-6000 CENTER FOR SCIENCE IN THE PUBLIC INTEREST 1779 Church Street N.W. Washington D.C. 20036 June 4 1973 Food and Drug Administration Bureau of Drugs OTC Drugs Products Evaluation 5600 Fishers Lane Rockville MD 20852 Staff 109 OTC Drug Review Information Contraceptives Vaginal Drug Products and Other IV Human Safety Data on Talc VI A. Individual Active Components 5. Pertinent Medical and Scientific Literature 20 Henderson W.J. et al Tale and Carcinoma Carcinoma of the Ovary and Cervix J. Obstet Gyn Brit Comm 78 266 1971 ---- Blejer H.P. and Arlon R. Tale a Possible Occupational and Environmental Carcinogen J. Occup Med 15 92 1973 Summary Statement is commonly used in the manufacture and packaging of condoms and diaphragms Henderson's study revealed the presence of talc deeply imbedded in the majority of primary malignant ovarian and cervical tumors examined The fact that these researchers could not find tale in thorough studies of a secondary tumor and the fact that no asbestos was found in any of the tissue studied support the hypothesis that talc per se nad a role in causing malignancies to develop Blejer and Arlon develop the hypothesis of tale carcinogenicity in their recseinmtilalriitteyratbuerteweernevtiaelwc and citing the strong chemical certain asbestiform minerals which have been proven to be carcinogenic agents One problem in trying to isolate the effects of pure talc is the fact that most talc deposits and talc products contain traces to large fractions of tremolite asbestos On August 12 1972 the FDA proposed to ban the use of asbestoscontaining talcs in the preparation and packaging of foods Federal Register v 37 no 157 It would OTC Drugs Products Evaluation Staff 2 certainly be contaminated appropriate to ban the use of asbestostalcs in contraceptives other vaginal drug products and cosmetics immediately In view of Henderson's report and some points made by Blejer and consider that talc Arlon there per se is a is clearly reason to possible carcinogen In view of this introduction of it would be prudent to minimize the bearing contraceptives into the vagina where the talc may easily find its way to prime cancer sites As talcum cosmetic powders when used by females and males and of talc insult vaginal sprays are additional sources to the female genital tract it is obvious that FDA's findings and actions on talc both pure talc and ceptives will asbestos contaminated talc in contra- have direct implications for talc in cosmetics Sincerely yours| Barry Castleman Michael Jacobson ) November 13 1973 Mr. Barry Castleman Center for Science in the Public 1779 Church Street W. Washington D.C. 20036 Interest Dear Mr. Castleman Thank you for your letter of October 30 1973 As requested we are attaching a copy of our Talc Safety Literature Review which has been recently updated I hope you will find it useful Very truly yours JOHNSON & JOHNSON W. Nashed Ph.D. Director of Science Information wn Attach 1 vol bcc Mr. D. Clare Dr. R. Fuller Dr. G. Hildick Mr. D. D. Johnston Mr. J. Melton Dr. T. Shelley Mr. H. Stolzer Dr. D. Petterson Protected Document to Protective Order 2 of 2 JNJ 000261164 Pltf_JNJ_00038478 202 332-6000 CENTER FOR SCIENCE IN THE PUBLIC INTEREST 1779 Church Street N.W. Washington D.C. 20036 October 30 1973 W. Nashed Ph.D. Director of Science Information Johnson and Johnson Company New Brunswick New Jersey Dear Dr. Nashed I read with interest a copy of your informative booklet Talc Safety submitted to the Food -A and Literature Review Drug Administration which was this March I would be grateful if you would send me a copy Sincerely yours Barry Castleman Protected Document to Protective Order 1 of 1 JNJ 000261166 Pltf_JNJ_00038480 en | ion ENVIRONMENTAL DEFENSE * FUND a 1294 1525 18th STREET NW WASHINGTON D.C. 20036/202 833-1485 January 28 1974 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fishers Lane Rockville Md 20852 \ . , RE ~ DAProposed Rulemaking relating to Asbestos Particles in Food and Drugs F.R. Sept. 28 1973 Dear Sir The noted proposal invited comments from interested or before December 27 1973 The Environmental parties on Science in the Public Interest Defense Fund and the Center for did file such comments before that date Since that time we have had the opportunity to consider the Comment of 12/21 filed by Manville M on the same proposal As a result we comment with the hope that it are now submitting a supplemental although late can be considered as well This comment can be summarized by two statements a We to the described use of containing talc do not object if it is shown that for pitch control in food and drug papers with which the pa- such talc does not migrate into food or drugs is in contact and b the use of additional contain- pienrg talc for brightness filling or any other purpose should not - be acceptable in food and drug wrappings make There are a number of statements in Section 3 of the M Comment Health Hazard of Ingestion to which we would take strong We do not wish any of the statements which we here exception that asbestos ingestion can be assumed to to indicate agreement believe that such an assumption is just- be harmless We do not use of talc ified However this question is not relevant to any which does not give rise to asbestos ingestion NEW YORK CITY PROGRAM SUPPORT OFFICE WASHINGTON DC BERKELEY CALIF DENVER COL OFFICES IN EAST SETAUKET NY MAIN OFFICE EI EI 0134952 Protected Document to Protective Order 1 of 3 JNJ 000288719 Pltf_JNJ_00047581 2 1295 We have considered the matter of talc use in the manufac- : ture of paper used for food packaging M which contains up to % tremolite by volume states and is that used talc for pitch control becomes locked into place in the paper and will not migrate into food with which it is in contact M further main- tains that due to talc's unique surface properties no equivalent substitutes are known and that surface active agents if used as an alternative to talc are a cause of pollution at pulpmills We are now making our own appraisal of the environmental impact of talc and talc systems for pitch control However it is our preliminary opinion that the advantages of the use of talc for pitch control need not be sacrificed if as M's tests indicate the incorporated talc does not migrate from papers to food It is our understanding that tale for control is added during pulping in amounts up to 1.5 with further addition of as much as 23 during paper making These figures were given by Manville in their December 21 1973 Comment to you If testing by procedures approved by the FDA does establish that no tremolite will migrate from paper to any food or drug object duringforseeable conditions of use we would not use of talc containing up to % tremolite by volume to this in the amounts notea d bove for the purpose of pitch control Use of talc for other purposes in food and drug wrappings not should 20 to 30 be allowed For example Manville also sells a tremolite talc for use as a functional filler in paper making and says that such filler is used little in making food papers Normal rates of talc addition for this purpose exceed the combined amounts used in pitch control and serve only an admittedly cosmetic purpose Where manufactures require such brighteners for food or drug wrappings substitutes for talc such as titanium dioxide can be used As the use of 5 to 15 percent talc containing 20 to 30 tremolite constitutes a relatively massive amount of tremolite added we believe that the use of talc for brightness filling in food and drug papersshould be prohibited immediately It is unlikely that papers with such high talc loading would completely retain their tale during the tearing abrasion and repeated foldings to which some food papers are subjected M states that the use of such tale papers for food and drug packaging would be unusual due to high cost Nevertheless we believe that such use should be explicitly prohibited in the regulation to be promulgated by FDA Protected Document to Protective Order 2 of 3 0134953 JNJ 000288720 Pltf_JNJ_00047581 1296 We are unable to comment on the recycled paper since we have no acceptability of treated retained after the waste information as to how much talc is more or less pulp stock is reclaimed whether it securely locked in than talc added for control and to what extent recycled paper is used for pitch direct wrapping of food and drugs We apt to contain other are aware that recycled paper is contaminants unsuitable for food and i.e. which can make it these points before drug wrapping We urge FDA to approving the use of recycled paper cfloarrify contact with food and drugs direct - . Sincerely yours , Lucil FAdamson FAdamson Lucile F. Adamson Ph.D. Environmental Defense Fund ---- CastlemanCastleman Castleman Barry Center for Science in the Public Interest LFA mew Protected Document to Protective Order 3 of 3 0134954 JNJ 000288721 Pltf_JNJ_00047581 te by Sd MARYPIRG MARYLAND PUBLIC INTEREST RESEARCH GROUP INC 3110 Main Dining Hall Consumeriam College Park Maryland University of Maryland 301 454-5601 20742 -- ----, --, __ emer pepe oF ee Hymne OS ee April 17 1975 | Dr. Gavin Hildick M.D. F.A.A.P. Director of Clinical Research Johnson & Johnson New Brunswick New Jersey 08903 Dear Dr. Hildick Several years ago 1972 in response I received a letter from you Septemb1er 9 to my concern that talc per se may be a ~ carcinogen You referred to several ongoing studies and I would like to receive prints or reports of any that have been completed I would also like to know of any new literature 1972- in which cohorts of exposed individuals were followed up for mortality any case reports regarding the possible carcinogenicity of talc and pertinent animal studies Specifically your letter mentioned 1 controlled studies on hamsters inwhich talc was introduced into the lungs and pleura separate extensive animal inhalation studies with talc 3 an extensive epidemiological survey of the cause of death in a group of exposed workers 4 other studies on the mortality of talc miners I hope this request is not overly burdensome As sometimes asked about the health effects of talc as date on the literature as possible one who is I try to keep Sincerely ljk CR Barry Castleman Environmental Engineer | 2021387-7595 2021387-7595 2021387-7595 Protected Document to Protective Order 1 of1 JNJ 000261538 Pltf_JNJ_00038617 March 17 1975 Page 53 FOOD CHEMICAL NEWS r~ FDA DELAYS ACTION ON CONTAINING TALC IN FOOD March 14 said that available information The Food and Drug Administration on talc in foods acknowledging that it will does not warrant a ban on containing delay any action on its pending proposal to institute such a ban See FOOD CHEMICAL NEWS Oct. 1 1973 Page 37 to At the same time FDA withdrew its proposal to tie the generally use of talc in packaging paper and paperboard the absence particles The agency also reaffirmed its decision not to propose of containing filters in food and beverage processing recognized as safe of asbestos limitations on use dealing with asbestos particles in drugs for The agency did issue a regulation the comments filed on and at the same time discussed at length parenteral injection and in packaging See FOOD CHEMICAL its proposals dealing with talc in food drugs 18 Dec. 3 1973 Page 2 Dec. 10 1973 Page 3 Dec. NEWS Oct. 22 1973 Pa7ge1974 Page 30 Jan. 14 1974 Page 30 and Feb. 18 24 1973 Page 20 Jan. 1974 , Page 16 with other agencies extensive experiments FDA noted that it plans in conjunction a definitive determine if long term exposure to ingested asbestos fibers represents the to hazard to human health Until the study is completed or other data are available filters in the concluded that a prohibition of the use of containing agency containing talc as a food or food processing of food and beverages and of " due to lack of sufficient data additive or in drugs or drug ingredients is unwarranted Industry Investigations Urged by FDA all means of eliminating the use of However FDA urged manufacturers to investigate in formulation and such filters and talc and to keep the FDA informed about changes " processing of this type a final regulations for talc until an acceptable As expected FDA decided to delay any be developed for this method for determining the presence of asbestos particles can said is substance See FOOD CHEMICAL NEWS Feb. 17 Page 32 The agency actively pursuing research on methodology that the designated optical crystallographic method FDA did not agree with comments " but did recognize that an is unreliable when used by those experienced inuttihleityaratnd acceptance than indicated effective compliance method must have greater by the comments on the proposed method did not actually use the proposed method FDA said Most of those who commented with optical crystallography or a personal but reflected their general experience methods The proposed method was supported in none preference for other analye tix calpressed objection was the difficulty in using the in incon- of the comments Most members of one trade association resulted method A collaborative study by the method the agency sistent results and four of the ten participants could not use said Page 55 FOOD Page NEWS March March 17 limited the of ash recovered CHEMICAL CHEMICAL NEWS bulk recovered other products rice, Although Although detection limited by bulk ash recovered products such such as fresh wrapped limited packaged macaroni macaroni other meat and and corn flakes comment froazlenso demonstrated demonstrated these these products dried than than 10 asbestos comment limit said said of salt represents a pra ctical upper migration migration migration Concluding Concludic ng tohant tthaect paper represents represents practical practicalexpllai inem d ei xplained tthat that migration to asbestos asbestos consideration consideration paper paperbeoaxrtd rpaepmereboaarbdrasive salt as compared conclusion cot nclo usion "3s is based otherdry foods and unusually high asbestos content test tremolitic optapehrbeoarrd d% ry compared compared reported levels high use promulgation paperboard paperboard of use of asbestos promulgation any regulation regulation on the prohibition asbestos asbestos can FDA delayed delayed on prohibition prohibition of preparation foods and nonparenteral drugs more reliable data data can be filters for preparation concentration nonparenteral nonparentasbeesrtosaldrinking water and be obtained obtained on background of fibers regard the addition of asbestos filters filters regard decided not to issue a regulation that it had regulation regulation The governing agency stated stated its proposal in food and beverage issue comments comments governing the use asbestos filters of beverage beverage processing processing Some urged be regulated regulated on the basis the ingestion ingestion use filters of asbestos is safe small amounts lack of the ingestion ingestion reproducible that uniform and consistent regulations Commissioner agrees industry basis should be adopted on an method- this the lack of available method- In ology determining fibers beverages beverages foods determining asbestos the regulation regulation other Commissioner to propose regulation of before before handling other related matters any event the the comment handling since the Commissioner has decided to delay becomerumloiontg soincn e talc as a direct direct food or ingredient ingredient ingredient a final " or drug ingredient. and and the addition addition fibers fibers foods use asbestos available data the asbestos asbestos and nonparenteral nonparenteral nonparenteral drugs filters the data on controls municipal water are sufficiently sufficiently asbestos regulatory regulatory permit permit promulgation controls at time Noting Noting asbestoassbersetloisabsolmee some municipal watersuppcloimpeasraconbtrloles the the a Canadian Canadian indicated indicated beverages beverages comparable the asbestos content background background levels areas of the U. 5. Noting levels in areas the contro- contro- demonstrate hazard the methodology methodology ingestion of evidence evidence demonstrate hazard health presented presented ingestion oF versial nature evidence expected asbestos asbestos fibers normally talc used in food drugs drugs or food amounts containing talc or in expected and nonparentera nonparentera drug packaging foods FDA beverages , drugs prepared asbestos filters that -~ in drugs prepared prepared with filters, FDA concluded concluded drugs The with the use of asbestos the limitations or asbestos filters for use prohibition prohibition foods nonparenteral drugs and the amount preparation preparation preparation which asbestos nonparenteral nonparenteral nonparenteral and drugs drugs which talc asbestos asbestos fibers food and or which which for use in food asbestos fibers in tale Call from Dr. Bruce Semple Johnson & Johnson May 7 1975 201-524-5025 { Semple responded to my letter to Dr. Hildick to tell me of current studies on the effects of talc There are several reports that will be issued between now and September Talc miners and millers in Italy Choser for its pure talc and stable population Paper preprint will be sent in one month No. difference in mortality between miners and millers and controls More pneumoconiosis in controls more ir miners than millers the latter indicating that other dusts than talc produce the disease talcosis Semple thought there may be no pneumoconiosis caused by pure talc so I told him about the Mount Sinai case report on the man who cleaned ventilation equipment in the condom factory A prospective study is underway on millers dust levels are known and good ventilation has been there since 1971 Battelle hamster study congress exposures up to use to be presented in September at a world 750 times that with normal cosmetic talc I asked about Henderson's work and its implications He replied that Tenovus lab has been scientifically discredited over that work and Henderson is gone Problem was background sources of contamination that were not controlled The work has been repeated with better control Will be presented in September Baden Semple thinks the relative innocuousness of talc is because of its platy morphology that it easily picked up by the mucous stream and little is retained in the lungs