Document VeDNNyg6Qr0Boyxn55rbmgnN

FILE NAME: Johnson & Johnson (JAJ) DATE: 1972-1975 DOC#: JAJ212 DOCUMENT DESCRIPTION: Documents cited in Proof of Evidence [JAJ211] Our ref WJH/DMS Your ref ei /saun txI 2471 Date 4 t h , March, 19 7 5* I Dear Barry, I enclose a list of papers which I hope will be published in the near future on our work. The talc work is going to take a long time as there are so many questions to be answered. But if one takes into consideration the shape and knife-like shape of these particles it can obviously cause a good amount of tissue damage. The oxygen ashing system is working very well and we can now quantitate recovery per gram of tissue, as we can remove all the organic elements. Trust this information will keep you abreast with our present work. Best wishes, Yours sincerely, {W.J. HENDERSON) Dr. B arry C astlem an, C enter fo r S cience in th e P u b lic I n te r e s t, 1 7 7 9 , C h u rc h S t r e e t , N.W. W ashington, D .c . 20036. t `i 'ti li -------- - ' ^ . `/ffaM,|V.ft'jLfcr- a h ^ M a r i i h^n. tf ttm ,LL *M .,i 'BI JUL 271971 i ,V.-v ,X .s tf ,, ? ,< / `~ oV :.(*: * XV~-4-Y. r" (V X / / . vT ' '._' CONS a PROF SERVICE A il x r / / 7 / / / 7 . A l/'""'*-<l/tC>l'MPV/ SX / W ut- i-!. f A ^ u r i-tii Da ' X / X X X X X" ,. . -X <:n--C<U- zY. S id c - tU z c .'' c -7^ ,eX7 , X .jX t , 7; . -a X X// X ' ytrtS^C i'zG Z L<YJ /V //& & S / j'/u-iAiAii ^ I* . i X -X, <~^/ s-lsx. h* . '- * - X-X-if-r" , A <#-- ^ J* 7^ ^ --.. ~ < sp i **Crf i . y siYZ*?*-LYTZ'f^t. x X y y -Tl ( ) J ) X-X X ^ t? & -YY- P .X^"X ,a* ^ X cyv',,./s ,, : Protected Document-Subject to Protective Order X ^ - i ^ v '.-wr.-^/ --.' / ? .> / 7 >.',`fy,',1A/ L iC'4, ' C* di r,<// '>-- JNJ 000682902  * f !I k \ J I J4 i. \i \ i Ij j * Subject: Asbestos Inquiry-Mr. Barry Cast lemn -\CElVED New Brunswick, N.l. July 28, 1971 Dr. T. H. She!ley: JUL 2 '971 ^H.SHELLES Jack Walcott has asked me to direct the attached le tter from Barry Castleman to you. Hr. Castleman is in the Department of Environmental Engineering at Johns Hopkins University. From the tone of this le t t e r , i t seems clear that Mr. Castleman has s c i e n t i f i c knowledge far beyond the normal type of inquiry we have received from the public. The inquiry appears to require a more s c i e n t i f i c response than we have been using in handling consumer correspondence. Therefore, we believe that th is le tter should be handled by someone ! n RS-D. Before the response is sent to Mr. Castleman, it should be checked wi th Larry Foster. Thanks very much for your help. 1 \ GFT/lm Attachment Mr. J. T. Dettre Mr. L. G. Foster Dr, R. A. F u lle r Mr. R. J. Howland Mrs . D. Matsu 1 Mr. J. C. Walcott 1 Protected Document-Subject to Protective Order JNJ 000682901 DOMESTIC OPERATING COMPANY NEW B R U N S W IC K . N. J. A u g u st 2, 1971 M r. B arry C astlem an D epartm ent of E nvironm ental Engineering Johns-H opkins U niversity B a ltim o r e , Marj*Ja-od_2,1201 _____ D ear M r. C astlem an: This is in an sw er to your le tte r of Ju ly 25: 1. T he use of ta lc as a c o s m e tic ex ten d s fa r b ack in h is to r ic a l tim e. M ore specifically, Johnson & Johnson has m arketed baby pow der since 1895. 2. We have no asb esto s in our baby pow der. To prove th is, we have had extensive analytical w ork c a rried out by m ineralogists at the C olorado School of M ines, by M cCrone L ab o rato ries in C hicago and by P ro fe s s o r F re d P ooley at the U n iv ersity of W ales in C ardiff. P ro fe sso r Pooley is asso ciated w ith one of the teaching scientific groups studying the relationship of asbestos and other inorganic p a rtic le s to can cer. 3. We have no m eaningful inform ation reg ard in g baby pow der m an u factu red by o th er com panies. We su sp ect, how ever, that the " 5 to 25" p ercen t quoted by the new spapers is not based on carefully docum ented scientific evidence. I hope the above answ ers your questions. Thom as H. Shelled, P h. D D irector C entral R esearch L aboratories me MEMORANDUM OF A SYMPOSIUM ' August 3, 1,971 ASBESTOS AND TALC Held at the Food and Drug Administration 200 "C" Street, S.W. Washington, D.C. 20204 Moderator: Dr. Alfred Welssler, Director ' Division of Colors & Cosmetics Technology PLAINTIFFS EXHIBIT JNJ-95 SUMMARY The amount of asbestos fibers In talcum powder products, and the Inhalation health hazards associated with their presence, are subjects of current Interest but differing reports. At a symposium held on august 3 at the Food and Drug Administration 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 la working on the details of a laboratory procedure for the analysis of asbestos In talcum powders which will give consistent meaningful results. Accurate analyses for the amount of asbestos in talcum powder will be obtainable, according to many of the participants, only through the use of a battery of specialized Instruments and techniques, Including x-ray diffrac tion, polarizing optical microscopy, electron microscopy, and electron diffraction of selected particles. In addition to extensive discussions of the analytical methods for asbestos used by various laboratories, the group also considered such topics as the medical significance of asbestos and other fibers, and the mineralogy of asbestos and talc ore deposits. INTRODUCTION Dr. Welosler opened the meeting by outlining some of the events which had brought the question of asbestos particles In talc to the attention of FDA. He Indicated that In response to a letter from Jerome Kretchmer (Administrator Environmental Protection Agency, New York City) to HEW Secretary Richardson, on June 28, 1971 the FDA was taking steps to Investigate the problem of asbes tos particles in talc. ft s * As a first step the FDA would like to establish a laboratory procedure for the determination of asbestos in talcum powder products that will give meaningful and consistent results. Once the methodology is agreed upon FDA would be in a position to determine if such' products on the market contain asbestos fibers. The format of the meeting consisted of short presentations by each participant 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 minerologlst, 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 heve one cosmton 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 chry8otlle asbestos, which is by far the most common of the asbestoform minerals. It accounts for more than 95% of the asbestos fiber produced today. hre are five recognized asbestoform varieties of amphibole: crocidollte, amosite, anthophylllte, tremolite, and actinollte. . Although the amphiboles are cocmon rock-forming minerals, the asbestoform varieties are much less abundant than chrysotile (1 ). c. The empiHcal formula of talc and some asbestoform minerals can be represented as follows: Talc, M g 3 Si4 Oio (0H) 4 Serpentine Class Chrysotile, Mg3 Sij O 5 (OH)^ (1) Spell, S. and Lelneweber, J.P., Environmental Research 2 166-208 (1969) JNJNI fil nnnnn-MAn Page 3 Amphlbole Class Anthophyllite (Mg, Fe)^ Sig 022 (OH) 2 Tremolite C&2 Mgs Slg 022 (OH)2 ~ Actlnollte C a2 (Mg Fe>5 Sig Oj j (0H >2 d. It is not unusual to find large variations In the composition of a mineral within a relatively small area of a given deposit. The differences depend to a great extent on the mineralogy Involved. 2. Dr. Cralley of the National Institute for Occupational Safety and Health spoke on the fibrous content of cosmetic talcum products. His presentation, centered In part on a paper he co-authored entitled "Fibrous and Mineral Content of Cosmetic Talcum Products," Amer. In dustrial Ilvglene Association Journal. 29. 350-4 (1968). The following concJ.ucto7^ were made in this paper: "With the exception of 4 of the 22 cosmetic talcum products analyzed, the levels of free silica, cobalt, nickel, chromium, and manganese were generally of a low magnitude and within a narrow range. It is not known whether the four products represent a signif icant proportion of sales in the Industry or to what extent the sources of the talc in these four formu lations are the same as sources of talc specified for use in other talcum products in the competitive market. The levels of silica, chromium, and nickel ' in these four products are sufficiently high, however, to be of concern in their potential to cause disease. Ali of the 22 talcum products analyzed have an appre ciable fiber content, ranging from 8 to 30% by count of the total talcum particulates, and averaging 19%. The fibrous material was predominantly talc but pro bably contained minor amounts of tremolite, anthophyllitc, and chrysotlle as these are often present In fibrous talc mineral deposits. Cosmetic talcum products should be included as a source of the fibers, from which may be derived ferruginous bodies observed in the lungs of humans. The meaning of the presence of these ferruginous bodies, however, is uncertain." 3. The third discussion topic on the program dealt with the biological and medical significance of asbestos and other fibers. Three speakers addressed themselves to this topic. a. Dr. Selikoff of Mount Sinai School of Medicine outlined briefly the history of fibrosis in asbestos workers which has been known to the medical profession for over 30 years. He reported that a few years ago when he met with FDA officials there was no apparent JNJNL61 000001141 Paga 4 problem presented to the general population with regard to asbestos. It vas considered at that time to be mainly an occupational problem. He reported that recently acquired knowledge has greatly increased his concern over the whole question of asbestos fibers in the environment. He felt that the new dimension added to the problem was the possi bility that lung cancer may result even from exposures at less than occupation levels. b. Dr. Hildick-Smith, Director of Clinical Research for Johnson and Johnson (J&J), outlined briefly the medical aspects of talc production and uses. He reported that J&J has been in the talc business for over 70 years. Talc, along with a whole host of other materials can give rise to a biological response. J&J has not noted any adverse effects from the use of talc in either their employees or reported in the literature. Talc manufactured by J&J is highly refined to produce a . "platy talc." Available data indicates that there is no health hazard associated with the use of cosmetic grade, talc. It was also pointed out that talc introduced surgically does not appar ently cause mesotheliomas. c. Dr. Gross of the Medical University of South Carolina reported that there Is very little if any data on the effects of talc in man or animal. Intratracheal Injection of talc in hamsters caused no 111 effects. In these animals no lung scarring was seen. Asbestos particles leBS than 5 microns In length reportedly do not cause lung damage. This point, however, has not been definitely confirmed. 4. Dr. Krayblll of FDA's Bureau of Foods reported that the subject of asbestos In food and the environment had been evaluated within the past few years and that no need for regulatory action was Indicated. Recent events, however, may require that the problem be restudled. Dr. Barzllal of the Bureau of Drugs reported that particulate matter in drug products are under study and that he would be very interested In learning about the analytical methodology which can be used for the identification of small particles. 5. Morris Kaplan of Consumers Union Indicated that we always seem to be looking at problems after they occur rather than anticipating them. He hoped that existing knowledge on the subject of asbestos and talc would be resolved in the interest of the consumer rather than in the Interest of the producer. JNJNL61 000001142 Page 5 6 * Dr. Estrin of the Cosmetics, Toiletry and Fragrance Association reported that the Association was ready to Join with FDA and the academic community to determine If there Is a consumer safety problem with talc. ANALYTICAL METHODOLOGY The afternoon session was devoted to a discussion of analytical methods that could be used for the Identification and determination of asbestos In talc. Six presentations were given outlining methods used In various laboratories. 1. Mr. Eisenberg of the Division of Microbiology reported on optical methods, such as the use of the polarizing microscope, for the detection of asbestoform minerals In talc. 2. Dr. Spell of Johns Manville Research Center reported that tremollte and chrysotlle could be determined In talc at a level of about 0.51 by x-ray diffraction. Dr. Spell felt, however, that the Important question to be answered is: How much gets into the lung of the person who is exposed? He suggested that a model be set up to determine the real exposure values. 3. Dr. Lewin, a consultant for Whittaker, Clark and Daniels reported that x-ray powder diffraction would be an ideal screening technique for rapidly determining which samples of talc contain asbestos minerals. He Indicated that there are talcs on the market which appear to be objectionable. 4. Dr. Langer and Dr. Maggiore of Mount Sinai reported that they use the following techniques to detect and determine asbestoform miner als; light microscopy, x-ray powder diffraction, electron microscopy, electron microprobe and electron diffraction. During the discussion that followed Dr. Langer'a presentation he was asked if he had analyzed a sample, referred to as 344-L, from Johnson and Johnson. He said that he had and that it was a high quality talc. He added that ail the talc producers represented at the meeting pro duced a high quality talc product. 5. Dr. Norwood of Charles Pfizer and Company agreed that x-ray diffrac tion would be the method of choice for the analysis of asbestos in talc. He indicated that by using step scanning and other sophisticated techniques you could probably detect down to 0 .1Z of chrysotlle 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 x-ray diffraction should be used. Kl IMI fid nnnnA* 4 so Page 6 7. In closing Che meeting Dr. Welssler thanked the participants and summarised the most promising approaches which might be used to determine the presence of asbestos in talc. Detailed procedures on analytical methodology will be sent to FDA by some of the participants at the meeting, and these will be synthesised by FDA and circulated for comments. rjohn A. Wenninger 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. Sellkoff, M.D. Arthur M. Langer, Ph.D. William J. Nicholson, Ph.D. . C. J. Maggiore, Ph.D. Mt. Sinai School of Medicine ft ft Malcolm Ross, Ph.D. U. S. Geological Survey Wilson Nashed, Ph.D. Gavin Hiidick-Smith, M.D. R. P. 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) Johnson & Johnson Dr. Nort/ood Harold D. Stanley, Jr., * Commr. Harold Rmer Ph.D. Charles Pfizer & Company I ,N.Y.C. Dept, of Air Resources S. R. Mountsier,' Jr. Prof. S.Z. Lewin (Consultant) Whittaker, Clark & Daniels Paul Gross, M.D. Medical University of South Carolina Sidney Spell, Ph.D. Johns-Manville Morris Kaplan Consumers Union Norman Estrin, Ph.D. Murray Berdick, Ph.D. Cosmetic, Toiletry & Fragrance Assn. Herman F. Kraybill, Ph.D. Robert M. Schaffner, Ph.D. Alfred Weissler, Ph.D. John M. Govdy, 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. Glttep 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. Comellusaen K. S. Heine Albert C. Kolbye, M.D. ' Page 7 Food and Drug It II It II II II H I II II I II I II II II II I Administration cc: To all Attendees JAWenningerrvbl:9-10-71 IM Ikll M a rc h 7, 1972 NEW B R U N S W IC K . N. J. M r. B arry C astlem an 305 W . B iddle S tre e t B altim ore, M aryland 21201 D ear M r. C astlem an: F ir s t, I m u st apo lo g ize fo r the delay in re p ly in g to your in q u iry ab o u t JOHN SON 'S B ran d Baby P o w d e r. Y our c a rd w as s e n t in in ter-o ffice m ail w ith som e correspondence in re -u sa b le envelope. The other m a il w as taken fro m the envelope w hich w as then placed in a sta c k to be used ag a in . U nfortunately, it w as not used again until this w eek, and your card w as re-discoK ered at that tim e. To answ er your q u estio n , Johnson & Johnson takes g re a t c a re in the fo rm u latio n and production of a ll its p ro d u cts. In the c a s e of JOHN SON 'S Baby P o w d e r, the ta lc co m es fro m o u r own m in es, sp ecifically selected for the quality of th eir ta lc . This h igh-grade talc is p ro cessed through rep eated "w ashings" in o rd e r to fre e it of im p u ritie s. U nder ca refu l an a ly sis by independent e x p e rts, the fin ish ed p ro d u ct has been shown to be free of asb e sto s. ' Thank you for your in te re s t in Johnson & Johnson products and p le a se fo rg iv e the d elay in re p ly in g to your c a r d . S incerely SS:ev Steven Sawchuk, M . D. A sso ciate D irecto r of C lin ical R esea rch J O $ U lc & jf' B & JL Jc s & u a f /? ? * - D ^ t ^ v fljA & a stso * /- v^^ v A 2$i<Ae $ j'U + 4~ U r& -y / f j t u f ^ U ^ J< rL ^ , J j& $ * l^ ^ K . **" A y d y ^ ' j t t -t7 A ^ u ^ J * ep<_ y ^ t c , ^C L& vijf'tZ^ S ts c s iy -e- ^ ^ C t 9^. L 4~ & 6*^ & 0-. r^ v-^-^ 3 4 ^ -- aJw J' ^ ^ a h iS Z s & y -^ U s v c /'j ---'^ ~<'~^4-' t--^e- A *Z 4U yJ-A Z & -i^ r 3 -s s y J 2 y& & < t^ 0 . . S U s is t^ o jL U A &- ^a^^>y y S _>n--*' m <5 ^ sK C t< < ? <*,**-& **- J jb u s* -V ^ X .^ s $ j-s *^StsM fl(ycj. A - w ^ (*--+ -^ **^ 0-) t ^ ^ t L i , Z u * s s & - ^ 7 4 -J ti* -. --<yat*e> 30% ? j^ i jiiM^jiil7l'ii-^rTj'';^^r^~'^Winn^ , V. j / ' yU srU ^ f & t< u z . A S T Z s i^ p :^ / S & k v is ^ ^ z^ o ^ ' -*-*- < t^ c ^ ^ y u ^ it^ c z . Y -2 A /~ C L ^2 ` CZ&Us 04lX - s * ^ < 2^ Z > + < J/ ^ ^ y u ^ /') /^ -V u-C - -et & Y '^ Lj ^ e tf 4 . Y , s * Z & Z L , D /t. . s ^ /L ts tfu if ---o - ^ U i z d c d L \j f^ g . e fi-^ a j f j L t ^ / rV -^ l o ^ ` i ~& 7yfi& <*C <st. ^c<s*& C C s^ -f I "2 r & y t s s t * l a ~ ^ ^ ' ! --<^'i~- /< t4<, ^(/Ui/ *?^. /~ -^*vt X ; ^4 45*-^>^ ^fcy? ^ -- yyr p-t- v / / sC i/V -tiJ !^!*->^ y ^ a i ^ slf& * c c ^ y*^z*<ru-c<i?c* *- -y L O -x tf - Y ~ * -^ ~ h s -C L ^ A ^ t~ - s &<2* 44^. f ^ < 5 ~ d t ~ lS f ~2-4>C>t (? 7/^ <Z *tisd -jCjCc^t*? A y V tM - ' < /^ < ^ - * > a ^ jZ ^ L c y & a - J i y - i . < ^ a ^ < ^ e sW 0-~ .y i y y^ P -r^ Y s& y- 5 .7 ^ A ^ -r NEW B R U N SW ICK . N J. P0" S eptem ber 19, 1972 M r. B arry I. C astlem an 305 W est B iddle S tre e t B altim o re, M aryland 21201 Dear M r. C astlem an: I am taking the lib erty of reply g to your le tte r dated A ugust 3, ad d ressed to D r. T. H. Shelle D irecto r of our C entral R esearch L aboratories. F irs t, : et m e express our a p p re c ia tio n o f your b rin g in g to o u r atte c ;ion your c o n c e rn about the possibility th at talc by itse lf m ay be carcinogen. As we m a rk e t talc we have re a l co n cern about ally p otential h arm fu l effects it m ay have and have been m onito ing on a continuing b asis the w orld lite ra tu re on the biologic tl activity of ta lc . We a re p rim a rily in te re ste d in determ ining rhether the cosm etic use of talc can cause any harm ful effects and at this tim e have no re a so n to b eliev e th a t ta lc alone w ill iduce n eo p lastic ch anges. The p ublication by K leinfeld (Ar ;h. E x p er. H ealth, 14: 663-7, 1967) th at you m entioned in your e tte r is fam iliar to us a n d , a s you k now , r e p o r t s o n th e in c id e n i;e o f p u lm o n a ry c a n c e r in m in ers w orking in talc m ines w hich cdntained trem o lite and s e rp e n tin e . I am subm itting som e points~wh ch support our po sitio n th at pure talc is not a carcinogen w hich oay be of in te re st to you. 1. The m onitoring of adverse ( ffects relating to the co m m ercial use of a prc duct th at has been m ark eted for over 70 years by us and used cosm etically for centuries. 2 . T h e c o n tin u in g re v ie w o f th< w o rld l i t e r a t u r e on talc shows that it has been sed therapeutically w hen in tro d u c e d into th e pie a ra i ca v ity , has been M r. B arry I. G astlem an -2- S eptem ber 19, 1972 I introduced into the peritonea] cavity from ru p tu red su rg ica l gloves and has been re sp ire d by in d u strial w o rk ers. In both the p leu ral cavity and the peritoneal cavrty talc produces local fib ro sis in the tissu es snd to date we have not been able to find any repc rts of cancer in the extensive m edical lite ra tire on this subject. E x ce ssiv e exposure to talc c iu s e s ta lc o sis in m in e rs, and I know of no d a ti to indicate that ca n cer o f the lung o ccu rs in 3uch m in e rs exposed to talc fre e of asb esto s. * 3. C o n tro lled stu d ies have beeD conducted in h a m s te rs in w hich talc w as introduced into lungs and p leu ra and the re su lts showed no cancer developm ent when the an im als w ere followed for th e ir life. T hese data w ere in co n trast to re su lts obtained when asbestos was used in place cf ta lc . A paper on these studies w ill shortly be reported in the m edical lite ra tu re . 4 . In o r d e r to c o n f ir m th e fin d in g s r e p o r t e d in *3*, two sep a rate, extensive anim al studies are being con ducted independently in whic h the an im als w ill inhale talc for d ifferen t tim e perio is and w ill be followed for th eir lifetim e and then e cammed histologically. Your com m ent con cern in g th e follow up of ta lc m in e rs to d e te rm in e th e c a u se of th e ir d eath is p er vinent but is tim e consum ing, and the num bers involved a re relativ ely (m all. H ow ever, in o rd er to obtain epidem iological data m o re rapic ly, we a re c u rre n tly follow ing an extensive epidem iological su rv ey of the cause of d eath in a larg e group of in d u stria l w o rk ers expose 1 to talc w ith a view to d e te r m ining w h eth er they d iffe r fro m o th er ap p ro p ria te popu latio n s. In addition we are attem pting to obtain data on the cause of death of *Van O rstra n d , H .D .: T alc pneum oconiosis. C h e st, 58(1):2, July, 1970 M r. B arry I. C astlem an -3t S e p te m b e r 19 1972 ta lc m in e r s an d d e te r m in e if th e c a u s e o: d e a th d iffe rs fro m o th e r p o p u la tio n s . I am hopeful that the com m ents [ have subm itted w ill be of a ssista n c e to you. We ap p reciate your in te re st in w riting to us and look forw ard to supplying you w ith p ertin en t published data as they becom e a v a ila b le . S incerely yours. G H S:M M S A j'W G avin H ildic iinith, M . D. ,F .A .A .F . D irector C linical R esearch Call from Dr. Bruce Semple, Johnson & Johnson May 7, 1975 201-524-5025 i Semple responded to my letter to Dr, HI]dick-Smith, 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 it3 pure talc and stable population. Paper preprint will le sent in one month. Ko difference in mortality between miners *nd millers and controls. More pneumoconiosis in contrls, more ir miners than millers (the latfler indicating that other dusts than talc produce the disease talcosie). Semple thought there may be no pneumoconiosis caused by pure talc, so told him about the Mount Sinai case report on the man who cleaned ventilaticn 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... to be presented in September at a world congress, exposures up to 750 times that with normal cosmetic talc use. I asked about Henderson's work and its jimplications. He replied that Tenovus lab has been "scientificall y discredited" over that work, and Henderson is gone. Problem wa* background sources of contamination that were not controlled. The work has been repeated with better control. Will be presented jn September (Baden). Semple thinks the relative innocuousnes! of talc is because of its platy morphology, that it easily picked up by the mucous stream and little is retained in the lungs. 'a rch 22 , 1972 Food and Drug Adminis tration Lapartment of Health, Education and Welfare 5600 Fishers Lane Rockville, 'Maryland 20?,52 Attention: .Mr. John F. Palmer, M. o., Deputy Director bureau of Drugs `wir Or. Palmer; 1 art! writing to fine! out what the FT>A Is doing; to research the .inspected carcinogenic!tv of talcs (with and without tremolito Asbestos) ; and what measures are being taken to safeguard the public against exposure to ashesto--containing consumer products (building materials, fabrics, etc.). As you probably know, the National Institute for Occupational Safety and Health has just published the document, Crlterl for a Recommended Standard .... Occupttonal Exposure to Asbeotoa." The closing remark tn lection V, Development of Standard, reads, Thus, th Effect aftex several decades of a one-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 dally doses of exposure over manv years of work. Asbestos is known to have been used in over W O O applications Including filter media for production of drugs, cbftar^ cigars, home boiler Insulation, heat-resistant clothing, paper products, sprayed fireproofing insulation, and numerous building products. Talc la mineralogically similar to asbestos, and in a survey of 51 commercial talcs in 1942, 17 were found to have greater than trac amounts of tremolitts asbestos, which frequently occurs combined with talc denoaits. Recent publications have pointed out the possibility of talc causing ovarian cancer mu! stomach cancer (in Japan), however, as far as I know, no one hay been able to firmly establish talc as being either carcinogenic or harmless. The nsoflt disturbing use of talc know is in recently-marketed fminieo hygiene spray. Also, aw. cosmetic powders have strikingly high fibrous content. Any information you can send about the TOA'o activities on aabestos and talc will bo deeply appreciated. BTC/c*.s c.v. Hr. Earl 'Meyers AT. Jerome Goldstein Sincerely yours, ? Barry T V Gastleraan nivision of Air Pollution and Industrial Hygiene Bureau of Dnvtronnent.al Servicon DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PU BLIC H EA LTH S E R V IC E FO O D AND D R U G A D M IN ISTR A TIO N W A SH IN G TO N . 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 Hilien Road Towson, Maryland 21204 Dear Mr. Castleman: Your inquiry of March 22, 1972 to Dr. John Palmer concerning asbestos has been referred to me for reply. 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 contaminant. We now have several methods which we are preparing to apply to commercially available talcs. We do not anticipate that the air levels of asbestos fibers incident to the use of talc will be any 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 to ban asbestos coats and other garments except in those circumstances where asbestos clothing is necessary for fireproofing. A copy of this proposal is also enclosed (February 18th) Building materials as such do not come directly within the purview of the Food, Drug and Cosmetic Act. If no other agency is prepared to deal with this problem it is possible that the Hazardous Substances Act could be stretched to cover it, however we would require advice from our General Counsel before attempting any action in this area. - 2- In addition to the above problems we are also investigating the incidence and significance of asbestos fibers in liquid drugs and beverages. I hope this is the information you desire. Sincerely yours, n M. Go istant Director for Medical Review Division of Colors & Cosmetics Technology Office of Product Technology Enclosures April 13, 1972 Division of Colors and Cosmetics Technology Office of Product Technology Food and Drug Administration Washington, D.C. 20204 Attention: Dr, John M. Gowdy Assistant Director for Medical Review Dear Dr. Gowdy: 1 am writing in reply to your letter of April 6, about the FDA's studies on talc and asbestea containing products. It is apparent that no epidemiological or toxicological studies are being performed by FDA on talcs without asbestos. It also appears that, although the FDA could probably require labeling of asbestos-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 II.S. government agency which has responsi bility 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. 1 am also disturbed about the use of talc, a suspected carcinogen, as a iiajor constituent in cosmetic powders and perfumed vaginal spaays (its use in dusting surgical gSoves 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 asbestos-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 (do-it-yourself home boiler Insulation of asbestos, talc vaginal sprays, asbestos filters in processing foods and drugs, asbestos "binder" in cigars, etc.) - will remain. Correct F-joJ .lui 'ni" Adi-siriistraff od Apri] ]]., X H 2 Pn?" two n 1. f I a; v r o n r , frut ino. ' t Chi 3 t h rN ponti . b i l i ty o f t h T`oo nini ' tuo A drctul strafelai? lre 'ry t r u " '- o o r s . S tC /cm CC: Seuator Charles M. Hathlas Bapresentative Paul S. Sarbanes 'iarrv T. Cn^tlewan Tacimi ca.I T orvi ceri P e c tin a .`HVision of Air Pollution sno T n riu s trin i iena Itureau o f Fnvl romnttnt n i V orvicea DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PU BLIC H EA LTH S E R V IC E FO O D AND D RU G A D M IN ISTR A TIO N W ASH INGTON . O C 20204 May 2, 1972 Mr. B a rry C astiem an T echnical S ervices S ection D iv is io n o f A ir P o llu tio n and I n d u s tr ia l H ygiene Bureau of E nvironm ental S erv ices B altim o re County D epartm ent o f H ealth M aryland A venue and H ille n Road Towson, M aryland 21204 D e ar Mr. C astiem an : Thank you fo r your l e t t e r o f A p ril 25, 1972, and th e en c lo se d m a te r ia l. D u rin g th e p a s t s ix m onths v a rio u s members o f th e Food and Drug A d m in istra tio n have had a number of co n feren ces w ith D r. S e lik o ff and h is s t a f f h e r e and i n New Y o rk . We h a v e c o l l e c t e d and re v ie w e d a b o u t one hundred papers on asb esto s to x ic ity . L arg ely because o f th e long tim e iag and a ls o because of a re lu c ta n c e to a llo w human ex p o su re to a p o t e n t i a l l y to x ic s u b s ta n c e th e d ose re sp o n se re la tio n s h ip s o f a sb e sto s to x ic ity a re undeterm ined. The in d u s tr ia l to l e r a n c e r e s t s on r a t h e r sh ak y g ro u n d , how ever i t w i l l be 20 to 40 y e a rs b e fo re i t can be d eterm in ed w hether i t is too high o r to o low. In th e m eantim e, tre m o iite , because i t is not w idely used, does not have th e background of proven in ju ry as does c h ry s o tiie . I have ta lk e d w ith som e e x p e r t s who f e e l t h a t t r e m o i i t e i s i e s s h a z a rd o u s th a n o t h e r form s o f a sb e sto s. T his p o in t can not be s e ttle d by argum ent. W ith re g a rd to c o sm e tic s, th e Food, D rug and C osm etic A ct, w hich governs o u r a c t i v i t i e s s t a t e s p r e c is e ly th a t p ro d u c ts m ust be shown to c o n ta in a harm ful or d e le te rio u s substance b efo re they are su b je c t to a c tio n , i .e . The FDA m u st be p r e p a r e d t o p ro v e a c o s m e tic i s h a z a r d o u s b e f o r e i t c a n act ag ain st i t . Condoms and diaphragm s a re d u sted w ith t a ! c . H enderson e t a l (H e n d e rs o n , W. J . , C. A. F . J o s l i n , A. C. T u r n b u l l and K. G r i f f i t h s , i Page 2 - Mr. Barry Castlernan T a l c an d c a r c in o m a o f t h e o v a r y and c e r v i x , J . O b s t e t G y n e co l B r. Commonw, 78:266 - 272, (M arch), 1971)j w ere a b le to d em o n strate ta lc , but not a sb e sto s w ith in m alignant tis s u e . U n fo rtu n a te ly , th ey a lso noted ta lc p a r tic le s in norm al tis s u e . I w ould v e ry much l i k e to s e e th e r e s u l t s o f a s u rv e y su ch as you d is c u s s . T h e re may b e a p ro b le m i n t h a t women who do n o t u s e t a l c d u s te d c o n tr a c e p t i v e s may h av e b ee n exam ined w ith t a t d u s te d g lo v e s so t h a t t h e r e may be some problem in d e v e lo p in g a c o n tro l group. S in cerely yours, /A ssista n t D ire c to r fo r M edical A f f a i r s ^ /D iv is io n of C olors & C osm etics Technology O ffic e o f P roduct Technology / C H A R LE S MCC. M A TH IA S, J R . MARYLAND 'H C w ie E l a t e s Genette W ASHINGTON. O.C. 20910 June 15, 1972 REPLY TO: 1616 F ederal B uilding 31 Ho p k in s P laza Baltim ore, M aryland 2120T (30T ) -9 6 2 -4 B50 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 Tovson, Maryland 21201 Dear Mr. Castleman: Please find enclosed a copy of a letter I have received from the Department of Health, Education, and Welfare relative to asbestos-containing products. I hope the information provided in Mr. Meyer's letter will help to clarify some of the points you raised in your correspondence to the Food and 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, CM/esg Enclosure United States Senator DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PU BLIC H EA LTH S E R V IC E FO O D AND D RU G A D M IN ISTR A TIO N RO CKV ILLE, M ARYLAND 20852 JUN 7 1972 Honorable Charles McC. Mathias, Or. United States Senator Suite 1616, Federal Building 31 Hopkins Plaza Baltimore, Maryland 21201 Dear Senator Mathias: This is in fu rther reply to your le t t e r of A pril 20 concerning asbestos-containing products. The Food and Drug Administration i s aware of the recent concern over the presence of asbestos-form p a rtic le s 1n t a lc which may be used In food products. Since there is some d if f ic u lt y 1n Identifying asbestos In ta lc because o f th e ir chemical s im ila r it y , we are now in the process of evaluating the a v a ila b le a n a ly tic procedures for determination of asbestos 1n t a lc . However, in the meantime we are moving ahead with an alysis of products containing t a lc , with e xistin g methodology, for the presence o f asbestos-form p a r t ic le s . We are attempting to determine the degree of exposure by the average consumer to products containing these substances. We are also preparing a d raft fo r a proposed provisional regulation fo r the use in foods of t a lc which i s free of asbestos-form p a rtic le s. Funds fo r animal studies on the toxicolog ical e ffe c ts of t a lc have not been a v a ila b le . A memorandum of need 1s being developed to ju s t if y the needed funds for contract feeding studies on s i l ic a t e s , including ta lc . The Bureau o f Product Safety of the Food and Drug Administration has reviewed the NIOSH document " C rite ria for a Recommended Standard . . . Occupations! Exposure to Asbestos'1 and the quotation Mr. Castleman yave from page V-3. We are unaware of any type o f asbestos product, intended for use in the household, which could be expected to give r is e to such concentrations of airborne fib e rs that i t s use would overwhelm the clearin g mechanism. Since long-term exposure to lev e ls contemplated by the standard would not be expected to overwhelm the clearin g mechanism, the level contemplated by the quoted passage must be much higher. Page 2 - Honorable Charles McC. Mathias, Jr. FDA has at the present time no s p e c ific regulatory actions underway except the prohibition of use of asbestos as a component of general use garments. He are continuing to explore the p o s s ib ilit y of hazard from other uses of asbestos-containing products in the home and methods fo r control of such hazards as are discovered, including in our consideration la b e lin g , construction c r it e r ia such as resin-bonding and i f i t should become necessary, banning sp e c ific as yet unidentified products, to control likeliho od of release of airborne fib e rs of asbestos. Thank you fo r your In te re s t. Please le t us know i f we can be of further assistance. Sincerely yours. Enclosure Constituent's le tte r Gerald F. Meyer, Director Office of Legislative Services cc: Your Washington O ffice (202) 332-0000 CENTER FOR SCIENCE IN THE PUBLIC INTEREST 1779 Church Street, N.W. Washington, D.C. 20036 June 1973 Food and Drug Administration Bureau of Drugs OTC Drugs Products Evaluation 5600 Fishers L a n e , Rockville, MD 20352 Staff (BD-109) OTC Drug Review Information^-Contraceptives and Other Vaginal Drug Products 1 IV. Human Safety Data on Talc A. Individual Active Components 5. Pertinent Medical and Scientific Literature. a. Henderson,. W.J. et al, "Talc and Carcinoma of the Ovary and Cervix," J. Obstet. Gyru Brit. Comm., 81 266, 1971 b. Blejer, H.P. and Arlon, R . , "Talci a Possible Occupational and Environmental Carcinogen^" J. Occup. Med., _L! 92, 1973* VI. Summary Statement-- Talc is commonly used in the -t--- manufacture and packaging of condoms and diaphragms. Henderson* 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 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 nad a role in causing malignancies to develop. Blejer and Arlon develop the hypothesis of talc carcinogenicity in their recent literature review, citing the strong chemical similarity between talc and 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 S taff--Page 2 certainly be appropriate to ban the use of asbestoscontaminated talcs in contraceptives, other vaginal drug products, and cosmetics immediately In view of Henderson's report and some points made by Blejer and Arlon there is clearly reason to consider that talc per se is a "possible carcinogen." In view of this it would be prudent to minimize the introduction of talc-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 PDA's findings and actions on talc (both pure talc and asbestos-contaminated talc) in contra ceptives will have direct implications for talc in cosmetics. Sincerely yours, Barry Castieman Michael Jacob?on ne Number 494-3775 Hay 10, 1972 Sr. Albert Frltsch Center for Science in the Public 1346 Connecticut Avenue, N.W. Washington, D.C. Interest Dear Mr. Frltsch: I was referred to you by Kan Lessen. I am interested in research on the adverse effects on health of asbestos and talc, in particular carcinoganisis. Ken said that your canter performs action-oriented investigations and you might be working on chase topics now. As far as I know, no one has yat demonstrated, that non-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 very disturbing, in view of the widespread use of talc in infant and cosmetic powders, perfumed vaginal sprays, etc. My correspondence with FDA indicates that they arc doing e minimal job (analyzing talcs for asbestos) ebout regulating both asbestos end tele in consumer goods. 1 would like to know of ways to get them "interested." In my spare hours her*, 7 have reviewed some of the literature on cervical cancer epidemiology. I also understand that some, but not all, prophylactics are dusted with talc in processing and packaging. Dr. Abraham Lilienfeld at the Johns Uopkine 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 know your interest end activities in the subjects of eebestos end tele. I would be glad to come down end see you if you think it worthwhile. My best wishes ir your work. 81ncerely, BC;dh Barry Castleman. Technical Services Section Division of Air Pollution end 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 May 15, 1972 Barry Castleman Technical Services Section Division of Air Pollution Industrial Hygiene' Bureau of Environmental Services Baltimore Co Dept, of Health Towson, MD 21204 Dear Barry: Thanks for writing and showing your interest in the talc and asbestos question. There is no reason why we can't cooperate on a project in the full since our type of public interest work is so entirely different from 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 chemicals) will be willing to give us $10,000 for the coming year. 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. You are right in suspecting that the talcs are bad. Art Langer who works with Sellikoff's group at Mt. Sinai is very concerned about their many uses. I think the FDA 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 Forum in Europe plus seeing some public interest centers in Europe. I have a few free days next week and will be back after June 22. Sincerely yours, AiDerx j. r ntscn