Document 2Nq50QbvmE1JEDD1Bq2DD0x6a

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 ... We have no meaningful information regarding baby powder manufactured by other companies We suspect however that the 15 to 25 percent quotebdy the newspapers is not based on carefully documented scientific evidence I hope the above answers your questions Thomas H. Shelley Director Central Research Laboratories ; Mr. Barry Castleman Mr. L. G. Foster August 2 1971 The attached is I believe explanatory data from Bill Ashton I obtained the 1895 If you agree please send it out T. H. Shelley - ; | , . cc Dr. G. Hildick a Do co Dr. W. Nashed + . Talc File - 503 re ot ct 7 Protected Document to Protective Order . . . JNJNL61_000024920  Pt ae August 1971 eae eRe ane SE) On CO OR aoe wen S\ Riva (: svee p de deoi bib - sate L^' Mr. Earry Castleman oe Department of Environmental Engineering J.hns Hopkins University . > Ealtimore Maryland 21201 i. Dear Mr. Castleman This is in answer to your letter of July 25 . 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 Sincerely ) mc bcc Mr. L. G. Foster Dr. G. Hildick Dr. W. Nashed Protected Protected Document to Protective Fc File - 503 Thomas H. Shelley Ph.D Director , Central Research Laboratories . . 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 EXHIBIT PLAINTIFF'S JNJ ASBESTOS 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 presence health hazards associated with their interest but differing reports products and the inhalation are subjects of current At a symposium held on August 3 at the Food and Drug Administration attended by over 40 scientists physicians and consumers it was generally agreed _ that most talcum powders of major manufacturers are relatively free of asbestos Nevertheless on behalf of consumers FDA is working on the 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 on June 28 1971 tos particles in the FDA was talc taking steps to investigate the problem of asbes- JNJNL61_000001139 Lage rad 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 B. 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 1 asbestoform varieties are much less abundant than chrysotile 1 c The empirical formula of talc and some asbestoform minerals can be represented as follows Tale Mg3 S14 010 OH Serpentine Class Chrysotile M83 S12 05 OH 1 Speil S. and Leineweber J.P. Environmental Research 2 166-208 1969 JNJNL61 000001140 Amphibole Class Page 3 Tremolite Ca2 Mg5 Sig 022 OH a Ca2 Actinolite 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 Institut foer 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- 1968 350-4 - dustrial Hygiene Association Journal 29 conclusions were made in this paper The following With the exception of 4 of the 22 cosmetic taicum products analyzed the levels of free silica cobalt nickel chromium and manganese were generally of a low magnitude and within a narrow range It is not known whether the four products represent a signif- icant proportion of sales in the industry or to what extent the sources of the talc in these four forma- lations are the same as sources of talc specified for use in other talcum products in the competitive market The levels of silica chromium and nickel ' in these four products are sufficiently high however to be of concern in their potential to cause disease All of the 22 talcum products analyzed have an appre- ciable fiber content ranging from 8 to 30 by count of the total talcum particulates and averaging 19 The fibrous material was predominantly talc but probably 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 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 officials when the medical profession for over 30 years He reported that a few ago he met with FDA there was 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 Researfcohr 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 rise to a biological response J 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 talc It was also pointed out that talc introduced surgically does not appar- ently cause mesotheliomas ; c Dr. Gross of the Medical University of South Carolina reported that there is very little if any data on the effects of talc in man or animal Intratracheal injection of talc in hamsters caused no ill effects In these animals no lung scarring was seen Asbestos particles less than 5 microns in length reportedly do not cause lung damage This point however has not been - definitely confirmed 4. Dr. 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 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 3. 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 as 344 from Johnson and Johnson He said that he had and that it was a high quality tale He added that all the tale producers represented at the meeting pro- , duced 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 . 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 .IN.INI 61 000004442 | Page 6 . 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 ~ John A. a for comments Wenningu Wenningu Wenningu Weningu Assistant Chief Cosmetics Branch Division of Colors & Cosmetics Technology The following people attended the symposium Lewis J. Cralley Ph.D. _ National Institute of Occupational Safety and Health Cincinnati Ohio Irving J. Selikoff M.D. Arthur M. Langer Ph.D. William J. Nicholson Ph.D. C. J. Maggiore Ph.D. Mt. Sinai School of Medicine uw Malcolm Ross Ph.D. Wilson Nashed Ph.D. Gavin Hildick R. F. Rolle Ph.D. M.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 U. S. Geological Survey Johnson & Johnson " 11 11 11 +1 f1 11 - Dr. Norwood Harold D. Stanley Jr. Ph.D. Commr Harold Romer Charles Pfizer & Company " N.Y.C. Dept. of Air Resources S. R. Mountsier Jr. 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. Asen Cosmetic Toiletry & Fragrance e . IN INI 24 AAnAno soe 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 11 11 11 1 11 a 11 " 11 11 +1 11 = - " ih 11 cc To all Attendees JAWenninger 9-10-71 IN INI C 0 ARAnAno so tate chang gate Anes a ili am ssyisbsbbastnetendiss Se nec @ : RECEIVED RECEIVED RECEIVED RECEIVED RECEIVED RECEIVED JUL 27 1971 CONS & PROF SERVICE johnson johnson johnson Johnson Johnson and Johnson { johnson johnson and and : Johnson Johnson Johnson Dips Dips line line 1 Exconsel of Exconsel Exconsel Engineering Engineering Engineering Engineering Exconsel Exconsel Engineering Polins Polins Polins Polins Hopkin Hopkin Hopkin Stuiversity Stuiversity Stuiversity Stuiversity Stuiversity Baltimore Baltimore Baltimore Maryland fly fly fly fly fly fly 25 25 25 , 1971 1971 1971 1971 Maryland Maryland 212031 212031 New Brunswick New Jersey | @ santele os Dear presently iam literature finishing finishing a presently finishing literature review review review on health effectosf asbestosasbestos In assessing tthhee justification from of current calls for removal of asbestos asbestos asbestos pourers there are severathl ings talcumtalcum long 1 How have cosmetic talas in particular particular long Johnson's Johnson's souder been in suidspare suidspare to natali natali _: process 2 What would be involved cast plant fiber from in removing removing the the asbestos tale changes all talcum ( ) Do } talcum powderpsowders powders contain those those whichwhich do what is the range of tion olite conticng onting Any @ information information information you in in making making Protected Document to Protective Order can will appreciated provide willgreatly appreciated Sincerely SincerelySincerely Sincerely Sincerely CalmCaalmaCalma BinaBina Bina Bina Calma Calma JNJ 000682902 FILE NAME Johnson & Johnson JAJ DATE 1971 July 28 DOC JAJ089 DOCUMENT DESCRIPTION Memo RE Barry Castleman Letter Requesting Asbestos Health Information : nd x) : 4 j z 4 { j 1 F j 4 | { gq i . i@ 4 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 in & we believe that this letter should be handled by someone Before the response is sent to Mr. Castleman it should be checked with Larry Foster . Thanks very much for your help G. F. Tyrrell GFT 1m Attachment Attachment 3 CC Mr. J. T. Dettre Mr. L. G. Foster Dr. R. A. Fuller Mr. R. J. Howland Mrs. D. Matsu Mr. J. C. Walcott i fi | Protected Document to Protective Order JNJ 000682901 DEPARTMENT OF HEALTH EDUCATION AND WELFARE PUBLIC HEALTH SERVICE 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 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 tale 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 and Cosmetic Act If no other agency is prepared to the Food Drug that the Hazardous Substances deal with this problem it is possible Act could be stretched to cover it however we would require advice action in this area from our General Counsel before attempting any 2 In addition to the above problems we are also of asbestos fibers fibers in liquid and significance investigating the incidence drugs and beverages I hope this is the information you desire Sincerely yours Enclosures \ Division of Colors Office of Product Technology  ee Dee ot 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 talc 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 conteining 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 sprays asbestos filters in processing foods and drugs asbestos binder in cigars etc. - will remain Correct wm Food and ru Adainistration April 13 1972 Page twe me if I am wrone Administration but fun't this the responsibility of the ood and rug BIC cre Vary trul yours ---- Barry 1. Castleman Technical Services Section Mvision of Air Pollution sad Industrial M ieno Bureau of Environmental Services CC Senator Charles M. Mathias Representative Paul S. Sarbanes expo tos talu e r whie ch commenatcle ead st Reports of takeparticleisn ovarian tumor tissue J. Obstet Gynecol 78 266 1971 and excess lung cancer among workers with mixed tale tale asbestos asbestos asbestos exposure exposure -- ---- -- --...f--or concern but they no proof of tale hazard provide provide 7 * se oa ee : Ses7 rete Sa ee oo ee eyist sis a BE at ean aa 0 MF a Heston get as Hos = shit e e4) aes an A Wise a . to tte as 2a an Pe ts eneoie aeig naEe . ai he eeeto Po), end . BES Pa ee he, = amy Se OanRS ~ 92 oadee ESARYAle ats 5, % S,a Rs Sincerely, Barry I Castleman Johnson 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 TA T. H. Shelley Ph.D. Director Central Research Laboratories , ~ 4 4 T . . Johnson Subject Mr. Barry Castleman's re Asbestos letter TF TF TF New Brunswick N.J. August 10 1972 at Dr. G. Hildick set ie ema , Wohin The attached re info on talc toxicity is self explanatory I pt wet really think this demands a medical answer and would appreciate your handling ; . . 4 L T. H. S. ae mf ~ / att CC Mr. J. T. Dettre 7 4 Mr. L. G. Foster Dr. R. A. Fuller Mr. R. F. Kniffin 3 q Mrs. D. Matsu Dr. W. Nashed 4 Mr. R. C. Stites , RECEIVED AUG 11 1972 W. NASHED JOHNSON & JOHNSON Protected Document to Protective Order 1 of 1 JNJ 000261178 Pltf_JNJ_00038491 su CHARLES MCC MATHIAS JR MARYLAND Alnited States SenateSenateSenate 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 ee ae 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 containing products of 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 asbestos in talc because the available analytic are procedures now in the process of evaluating talc However in the for determination of asbestos in products containing meantime we talc with are moving ahead with analysis of of asbestos particles of exposure by the We eaxriesting methodology for the presence attempting to determine the degree substances We are aavlesroage consumer to products containing these preparing a draft for a proposed provisional Funds for animal studies on the not been available A toxicological effects of talc have justify the needed memorandum funds of need is being developed to including talc 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 Recommended Standard Castleman the quotation Mr. Castleman overwhelm the clearing mechanism Since contemplated by the standard would term exposure to levels clearing mechanism the level not be expected to overwhelm the must be much higher contemplated by the quoted passage Page 2 - Honorable Charles McC Mathias Jr. FDA has at the present time no specific regulatory actions except the prohibition of use of asbestos as underway use garments We are a component of general continuing to explore the possibility of hazard from other uses of 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 necessary banning likelihood of specific as yet unidentified asbestos release of airborne fibers of 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 discoxered 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 please you for 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 Tishers Lane Rockville Maryland 20252 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 overwhelus section V Development of Standard reads Thus the affect after several decades of a time acute dose of limited duration which the clearing mechanism and is retained in the lungs may be as harmful carcin producta ogenic as the cumulative effect of lower daily years of work Asbestos is known to have been including filter media for production of drugs insulation resistant clothing paper doses of exposure over many used in over 3000 applications cheap cigars home boiler sprayed fireproofing aa insulation and numerous building products ; Talc is mineralogically similar to asbestos and in a survey of 51 commercial talcs in 1942 17 were found to have greater than trace amounts of tremolite asbestos which frequently occurs combined with tale deposits Recent publications have pointed out the possibility of tale causing ovarian cancer and stomach cancer in Japan However as f^,r ad 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 4@ is hyglane sprays Also some cosmetic powders in recently have strikingly high f^'mining fibrous fibrous content. Any information you can send about the FDA's activities on asbestos and tale will be deeply appreciated ce 110 cms r Mr. Earl leyars Jerome Goldstein Sincerely youre Basay Castle can Basay Basay I Castle Castle can can 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 ee Se ern 4 DI Mr. Barry Castieman I Technical Services Section Division of Air Pollution and ee Industrial Hygiene ete Bureau of Environmental Services tor AG Baltimore County Department of Health cma Maryland Avenue and Hillen Road cs Towson Maryland 21204 - APES. Dear Mr. Castleman ee letter of April 25 1972 and the enclosed material T-Tant Thank you for your igeorle six months various members of the Food and Drug During the past with Dr. Selikoff and his a have had a number of conferences A Administration collected and reviewed about one staff here and in New York We have RE hundred papers on asbestos toxicity pape and also because of a reluctance a Largely because of the long time ag substance the dose response to a potentially toxic to allow human exposure of asbestos toxicity are undetermined The industrial be 20 to 40 relationships rather shaky ground however it will tolerance restist o cn an be determined whether it is too high or too low years before tremolite because it is not widely used have does not have talked with In the meantime of injury as does chrysotile I the background proven hazardous than other forms who feel that tremolite is Jess some experts not be settied by argument of asbestos This point can 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 before they are subject to action a harmful or deleterious substance before it can a cosmetic is hazardous The FDA must be prepared to prove 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 pasts ta Page 2 - Mr. Barry Castleman Talc and carcinoma of the ovary and cervix J. Obstet Gynecol Br Commonw 266 - 272 March 1971 were able to demonstrate talc but not asbestos within malignant tissue Unfortunately they also noted talc eoeAk particies in normal tissue ree oem 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 tac dusted gloves so that there may be some problem in developing a control group Sincerely yours Malin YoudyYoudy John M. M. Gowdy M.D. . 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 goverment 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 ~ to talc carries an excess risk of lung cancer oar ce cupvaetryiondailsteuxrpboisnugre in view of the widespread use of tale in infant and cosmetic powders perfumed vaginal sprays etc. My correspondence with FDA indicates that they are doing a minimal job analyzing tales 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 " have reviewed some of the literature on cervical cancer epidemiology I also understand that some but not all are dusted with tale in processing and packaging Dr. Abraham pLriolpihaynlfaecltdicast the Johns Hopkins School of Hygiene has an interest in tale also and I hope to work out some kind of study with him soon Please let me asbestos and talc I it worthwhile know your interest and activities in the subjects of would be glad to come down and see you if you think My best wishes in your work Sincerely BC Barry Castleman Tachnical 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 other be willing to give us 10,000 for the coming year chemicals will I would like to get together with you people and plot a cooperative program where we deliver items which are highly dangerous and 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 Congress of the United States House of Representatives Washington D.C. 20515 Dear Mr. Mr. Sarbanes the and Enclosed is my continued correspondance 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 hazard _ to Mr. Sarbanes I urge you to use your influence see that something is done about this situation Of course will be glad to discuss it at length with you or members of your staff at your convenience Sincerely Barry Castleman Technical Services Section Division of Air Pollution and Industrial Hygiene Bureau of Environmental Services IG Enel Johnson NEW BRUNSWICK N. J. 08903 September 19 1972 Mr. Barry 1. Castleman 305 West Biddle Street Baltimore Maryland 21201 Dear Mr. Castleman 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 let me express our appreciation of your bringing to our attention attention your concern about the possibility that tale 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 and at this time have no reason to believe that talc 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 Erde position am submitting some points which support our | that pure talc is not a carcinogen which may may 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 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 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 dati 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 used in place of talc A paper on these studies will shortly be reported in the medical literature 4 In 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 is 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 a large group of industrial workers expose i 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 o death differs from other populations I 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 er Allyifteiu,ia Clinical Gavin Hildick Director F.A.A. Clinical Research ENVIRONMENTAL DEFENSE . FUND 1276 | 1525 18th 20 36/202 XTON 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 Re Comments on the Food and Drug Administration proposed tion Asbestos Particles and Drugs 38 Fed Sept. 28 1973 Reg regula- in Food 27076-81 1 Dear Sir and We attach the comments the Center for Science in of the Environmental Defense Fund | 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 Sual Adamson Lucile F. Adamson Ph.D. Environmental Defense Fund 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 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 Contraceptives Vaginal Drug Products and Other IV Human Safety Data on Talc A. Individual Active Components 5. Pertinent Medical and Scientific Literature 20 Henderson W.J. et al Talc and Carcinoma Carcinoma of the Ovary and Cervix J. Obstet Gyn Brit Comm 78. 266 1971 VI bo Blejer P. and Arlon R. Talc~- 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 tale deeply imbedded in the majority of primary malignant ovarian and cervical tumors examined The fact that these researchers could not find talc 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 had 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 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 asbestos- asbestostalcs in contraceptives other vaginal drug products and cosmetics immediately In view of Henderson's report and some points made by Blejer and Arlon there consider that talc per se is a is clearly reason to possible carcinogen In view of this it would be prudent to minimize the introduction of 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 vaginal sprays are additional sources of talc insult to the female genital tract it is obvious that FDA's findings and actions on talc both pure talc and ceptives will contaminated tale in contra- have direct implications for talc in cosmetics Sincerely yours| Barry Castlewan Castlewan MJ 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 Tale Safety Literature Review which has been recently updated I hope you will find it useful r 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 BarryCasCtalesmtalneman Protected Document to Protective Order 1 of 1 JNJ 000261166 Pitf_JNJ_00038480 oan ne ENVIRONMENTAL -'' DEFENSE 1 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 i , RE FDA Proposed Rulemaking relating to Asbestos Particles in Food and Drugs F.R. Sept. 28 1973 Dear Sir The noted proposal invited comments from interested before December 27 1973 The Environmental parties on or for Science in the Public Interest Defense Fund and the Center did file such comments before that date Since that time we have had the opportunity to consider the Comment of 12/21 filed Manville M on the same proposal As a result we bayre now submitting a supplemental comment with the hope that it although late can be considered as well WASIGNA comment can WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA to the WASIGNA use of WASIGNA tale WASIGNA WASIGNA WASIGNA if WASIGNA WASIGNA shown WASIGNA for WASIGNA control in food and drug WASIGNA with which the pa- such talc WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA WASIGNA the WASIGNA of WASIGNA WASIGNA WiASnIGgNA talc for brightness WASIGNA WASIGNA any WASIGNA WASIGNA WASIGNA not WASIGNA be acceptable in food and drug wrappings 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 make 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 AI AI 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 states that talc which contains up to 5 tremolite by volume and is used for pitch control becomes locked into place in the paper and will not migrate into food with which it is in contact M further maintains that due to tale'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 tale for pitch control need not be sacrificed if as M's tests ifnodoidcate the incorporated talc does not migrate from papers to It is our understanding that tale for control is added during pulping in amounts up to 1.53 with further addition of as much as % 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 no will migrate from paper to any food or drug during forseeable conditions of use we would notobject to this use of talc containing uup t p o % tremolite by volume in the amounts notea d bove for the purpose of pitch control Use of talc for other purposes in food and drug wrappings Use should notbe allowed For example Manville also sells a 20 to 30tremolite tale 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 tale 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 high 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 0134953 JNJ 000288720 Pltf_JNJ_00047581 1296 We are unable to comment on the recycled paper since we have no acceptability of treated is retained after the waste information as to how much talc is more or less pulp stock is reclaimed whether control and securely locked in to what extent recycled than talc paper is added for it pitch wrapping of food and drugs We are used for direct apt to contain other contaminants aware that recycled paper is i.e. unsuitable for food and which can make it these points before drug wrapping We urge FDA to clarify contact with food approving and the use of recycled paper for direct drugs - . Sincerely yours Lucele Lucele Lucele Lucile F. Adamson Ph.D. Environmental Defense Fund Barry Barry CastlemanCastleman Castleman Center for Science in the Public Interest LFA Protected Document to Protective Order 3 of 3 i 0134954 JNJ 000288721 Pltf_JNJ_00047581 Sa. & 3110 Main Dining Hall College Park Maryland University of Maryland 301 454-5601 MARYPIRG MARYLAND PUBLIC INTEREST RESEARCH GROUP INC 20742 Consumeriam Consumeriam Consumeriam . Consumeriam er, a ne Consumeriam LED April 17 1975 Dr. Gavin Hildick M.D. Director of Clinical Research F.A.A.P. Johnson & Johnson New Brunswick New Jersey 08903 Dear Dr. Hildick Several years ago I received a letter from you September 19 1972 in response 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 BC 1jk Canon Barry Castleman Environmental Engineer | 2021387-7595 2021387-7595 2021387-7595 Protected Document to Protective Order 1 of 1 JNJ 000261538 Pltf_JNJ_00038617 ee March 17 1975 Page 53 FOOD CHEMICAL NEWS = 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 opn ecnodnit na gipn roi pon sag l to institute such a ban See FOOD delay any action on its 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 parenteral injection and at the same time discuasnsdedin apt alceknaggtihng See FOOD CHEMICAL its proposals dealing with talc in food drugs Oct. 22 1973 Page 18 Dec. 3 1973 Page 2 Dec. 10 1973 Page 3 Dec. and Feb. 18 NEWS 24 1973 Page 20 Jan. 7 1974 Page 30 Jan. 14 1974 Page 30 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 and of containing talc as a food or food processing of food and beverages unwarranted due to lack of sufficient data additive or in drugs or drug ingredients is 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 final regulations for talc until an acceptable FDA decided to delay any be developed for this As expected method for determining the presence of asbestos particles can said it 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 in the art than indicated effective compliance method must have greater utility and acceptance by the comments on the proposed method fo Most of those who commented did not actually use the proposed method FDA said or a personal but reflected their general experience with optical crystallography in none " preference for other analytical methods The proposed method was supported the difficulty in using the of the comments Most expressed objection was in incon- method A collaborative study by members of one trade associtahteiomnertehsouldtetdhe agency sistent results and four of the ten participants could not use said Page 55 FOOD Page NEWS meat March March 17 of ash recovered CHEMICAL CHEMICAL NEWS limited the bulk from products rice, Although Although detection limited by bulk ash recovered products such such as fresh wrapped limited packaged macaroni macaroni other and and corn flakes comment froazlenso demonstrated demonstrated these products dried than than p.p.b. asbestos comment limit said said of the salt represents a practical upper migration migration migration Concluding Concluding that practical practical upper represents represents migration to asbestos asbestos food paper paperboard explained explained that that consideration paper paperboard is based consideration abrasive salt as compared compared conclusion ig otherdry otherdry foods and unusually high extreme content test to high use tremolitic asbestos asbestos paperboard % compared compared reported levels paperboard promulgation paperboard of use of asbestos on the prohibition FDA delayed delayed promulgation any regulation prohibition of asbestos asbestos can and nonparenteral prohibition data data can filters filters for preparation preparation foods nonparenteral nonparenteral drugs more reliable and obtained on background concentration asbestos drinking water be obtained the addition of asbestos of asbestos filters filters regard regard decided not to issue a regulation that it had The governing agency stated stated its prfoiplotesrasl in food and beverage issue regulation regulation Some comments comments governing the use asbestos urged the basis of a beverage processing processing be regulated on lack evidence the ingestion ingestion use filters of asbestos is safe the ingestion ingestion small amounts industry that uniform and consistent regulations Commissioner agrees basis should be adopted on an method- this the lack of available reproducible method- ology ology determining fibers beverages beverages other foods determining asbestos to propose the regulation of before before the Commissiorneelarted matters any event regulation the the comment handling other the Commissioner moot since has decided to delay become talc a direct direct food or ingredient ingredient ingredient a final ruling on " or drug ingredient fibers fibers foods and and asbestos available data the addition addition asbestos and nonparenteral nonparenteral nonparenteral drugs use filters the data on the asbestos controls municipal water are sufficiently sufficiently asbestos regulatory regulatory permit permit promulgation controls at time Noting Noting asbestoassbersetloisabsolmee some municipal watersuppcloimpeasrasbailde the the a Canadian Canadian indicated indicated content beverages beverages comparable background background levels areas the asbestos the S. 8. Noting levels in areas of contro- the contro- demonstrate review 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 amounts amounts containing talc or expected expected and nonparentera nonparentera drug packaging beverages beverages foods filters drugs prepared asbestos filters -- -~ drugs drugs prepared prepared with filters FDA concluded concluded drugs The with the use of asbestos talc the limitations or asbestos filters for prohibition prohibition use the amount preparation preparation asbestos nonparenteral nonparenteral nonparenteral nonparenteral drfu oogdsand drugs drugs which of asbestos asbestos fibers in food drugs or which which asbestos fibers in tale for use 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 tale 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 tale 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