Document 3ezDZm75MnDn18pQmOpxXjV5D

FILE NAME: Johnson & Johnson (JAJ) DATE: 1971-1975 DOC#: JAJ210 DOCUMENT DESCRIPTION: Barry Castleman Letters & Communications D O M E S TIC O P E R A TIN G C O M P A N Y N E W B R U N S W IC K . N. J. A ugust 2, 1971 Mr. Barry Castlem an Department of Environm ental Engineering Johns-Hopkins U niversity B a ltim o r e , Mar.vland_2JL201 Dear Mr. Castlem an: This is in answ er to your letter of July 25: 1. The use of ta lc as a c o sm e tic extends far back in h isto r ic a l tim e. M ore specifically, Johnson & Johnson has m arketed baby powder since 1895. 2. We have no asb estos in our baby powder. To prove th is, we have had exten sive an alytical work carried out by m in eralogists at the C olorado School of M ines, by M cCrone L ab oratories in Chicago and by P r o fesso r Fred P ooley at the U n iversity of Wales in C ardiff. P ro fesso r P ooley is associated with one of the teaching scien tific groups studying the relationship of asb estos and other inorganic p articles to cancer. 3. We have no m eaningful inform ation regarding baby powder m an u factu red by oth er co m p a n ies. We su sp e c t, h o w ev er, that the "5 to 25" p ercen t quoted by the new spapers is not based on carefully documented scien tific evidence. I hope the above answ ers your questions. S in arerei' Thomas H. Shelle^ Ph. D D irector Central R esearch Laboratories me - -- ' " ` " ` VI ' r nMr nl ^j i.--------- ` ............................................................... ----------------------------------- , , I.m m t - - ' -II I t. i M rfv f n . ~ , i , . . .-- --------- M r. B arry Castlernan /> A ugust 2, 1971 Mr. L. G. F oster ! 1 .`5 T he attached is , I b e lie v e , se lf-e x p la n a to r y . I obtained the 1895 1 data from B ill A shton. i If you agree, p lease send it out. me cc: D r. G. H ildick-Sm ith D r . W. N ashed Talc F ile - 503 T . H. Shelley It Protected Document-Subject to Protective Order JNJNL61 000024920 August 2, 1971 M r, E arry C nstlem an D epartm ent of E nvironm ental E ngineering J . hns-H opkins U n iversity B a ltim o re, M aryland 21201 ' , Dear M r. C astlem an: T his is in an sw er to your letter of Ju ly 25: 1. The u se o f talc as a c o sm e tic exten d s far b ack in h isto r ic a l t i m e . M o r e s p e c i f i c a l l y , J o h n s o n Si J o h n so n h a s m a r k e te d Baby powder sin ce 1895. 2. Y/e have no a sb e sto s in our baby p ow d er. To p rove th is, w e . have had ex ten siv e a n alytical w ork carried out by m in era lo g ists at the C olorad o S ch ool of M in es, by IvlcCrone L a b o ra to ries in C hicago and by P r o fe s s o r F red P o o ley at the U n iv ersity of W ales in C ardiff. P r o fe sso r P o o ley is a sso cia ted w ith one of the teaching scien tific groups studying the relationsh ip of a sb esto s and other inorganic p a rticles to can cer. 3 . V7e h a v e no m e a n in g fu l in f o r m a t io n r e g a r d in g b ab y p o w d er m anufactured by other com p an ies. We su sp ect, how ever, that the "5 to 25" p ercen t quoted by the n ew sp apers is not b a sed on ca r efu lly docum ented s c ie n tific ev id en ce. I hope the above an sw ers your q u estion s, 4 S in cerely, me bcc: M r. L. G. F oster D r. G. rlildick -S m ith D r . \V. N a s h e d Document-Subject to Protective dfifclc F i l e - 503 Thom as H. Shelley, Ph. D D irector C entral R esearch L aboratories 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, 1,971 ASBESTOS AND TALC Held at the Food and Drug Administration 200 "C" Street, S.W. Washington, D.C. 20204 Moderator: Dr. Alfred Weissler, Director Division of Colors & Cosmetics Technology PLAINTIFF'S 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 is 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. Weissler opened the meeting by outlining some of the events which had brought the question of asbestos particles in talc to the attention of FDA. He indicated that in response to a letter from Jerome Kretchmer (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. L * As a first step the FDA would like to establish a laboratory procedure for the determination of asbestos in talcum powder products that will give meaningful and consistent results. Once the methodology is agreed upon FDA would be in a position to determine if such* products on the market contain asbestos fibers; The format of the meeting consisted of short presentations by each partici pant followed by informal discussions which served to pool the knowledge of the 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 mineralogist, outlined the various associations of asbestos mineral species with talc. During this presentation and the discussion which ensued the following salient points emerged: a. Definition: Asbestos is a generic term for a variety of hydrated silicate minerals which have one common attribute, the ability to be'separated into relatively soft, silky fibers. Although the name is ordinarily associated with those varieties which have technologic importance, it is applicable to all minerals which fit the above descriptions. The term "asbestoform minerals" is perhaps most descriptive (1 ). b. The known varieties of asbestoform minerals can be divided into two main classes on the basis of their crystal structures: serpentine and amphiboles. The sole member of the serpentine class is chrysotile asbestos, which is by far the most common of the asbestoform minerals. It accounts for more than 957. of the asbestos fiber produced today. There are five recognised asbestoform varieties of amphibole: crocidolite, amosite, anthophyllite, tremolite, and actinollte. . Although the amphiboles are coumon rock-forming minerals, the asbestoform varieties are much leps abundant than chrysotile (1 ). c. The empirical formula of talc and some asbestoform minerals can be represented as follows: Talc, Mg3 SI4 O1 0 (< )4 Serpentine Class Chrysotile, Mg3 Si2 O5 (OH) 4 (1) Spell, S. and Lelneweber, J.P., Environmental Research 2 166-208 (1969) JNJNLS1 nnnnn-i-iAn Page 3 Amphibole Class Anthophyllite (Mg, Pe) 7 Sig 02 2 (OH) 2 Tremolite Ca2 Mgs Slg 02 2 (OH) 2 Actinollte Ca2 (Mg Fe)j Sig (>22 (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," Araer. In dustrial Hygiene Association Journal. 29. 350-4 (1968). The following couclusicr-S re made in this paper: "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 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, anthophy llite, and chrysotile as these are often present in fibrous talc mineral deposits. Cosmetic talcum products should be included as a source of the fibers, from which may be derived ferruginous bodies observed in the lungs of humans. The meaning of the presence of these ferruginous bodies, however, is uncertain." 3. The third discussion topic on the program dealt with the biological and medical significance of asbestos and other fibers. Three speakers 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 was considered at that time to be mainly an occupational problem. He reported that recently acquired knowledge has greatly Increased his concern over the whole question of asbestos fibers In the environment. He felt that the new dimension added to the problem was the possi bility that lung cancer may result even from exposures at less than occupation levels. b. Dr. Hildlck-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 tise 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 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. Krayblil 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. 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 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 aabestoform minerals in talc. 2. Dr. Spell of Johns Manville Research Center reported that tremolite and chry80 tile could be determined in talc at a level of about 0.5T 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 all the talc producers represented at the meeting pro duced a high quality talc product. 5. Dr. Norwood of Charles Pfizer and Company agreed that x-ray 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 0.1% of chrysotlle in talc. 6. Dr. Hashed of Johnson and Johnson introduced Dr. Rolle who made available a table which outlined "Methods of Analysis of Fibers in Talc." (Copy attached). Dr. Rolle recommended that optical microscopy be used as a first step in detectingfibers 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. .IN .IM I fid AAAAAH A Page 6 7. In closing Che meeting Dr. Weissler thanked the participants and summarised the most promising approaches which might he used to determine the presence of asbestos in talc. Detailed procedures on analytical methodology will be sent to FDA by some of the participants at the meeting, and these will be synthesized by FDA and circulated for comments. 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. Magglore, Ph.D. Mt. Sinai School of Medicine It ft tl Malcolm Ross, Ph.D. U. S. Geological Survey Wilson Nashed, Ph.D. Gavin Hildlck-Smith, M.D. R. F. Rolle, Ph.D. T. H. Shelley, Ph.D. A. Goudle, Ph.D. Prof. F. D. Pooley (Consultant) W. T. Caneer (Consultant Ian M. Stewart, Ph.D. (Consultant) G. R. Grleger, Ph.D. (Consultant) Johnson & Johnson It II It tl tt tl II tl Dr. Norwood Harold D. Stanley, Jr., Ph.D. Charles Pfizer & Company II Commr. Harold Rosier ,N.Y.C. Dept, of Air Resources S. R. Mounts 1er,' Jr. Prof. S.Z. Lewin (Consultant) Whittaker, Clark & Daniels If 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. Iki iki Herman F. Kraybill, Ph.D. Robert M. Schaffner, Ph.D. Alfred Welssler, Ph.D. John M. Gowdy, M.D. Sylvan H. Hewburger, Ph.D. John A. Wenninger Charles J. Kokoskl, Ph.D. George Thompson, Ph.D. Dennis J. McGrath, M.D. J. W. Cook Hyman R. Gittep 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. Comellussen K. S. Heine Albert C. Kolbye, M.D. Page 7 Food and Drug Administration I II It II II II It II II II II II II It II II It II cc: To all Attendees JAWenninger :vbl:9-10-71 Iki iki .iM IttTiilttrii'kff'ftV'' I " ! * 1t n T<-,n x~ JUL 271971 CONS & PROF SERVICF / J . ... / ./ / r .. . / / / '.V /:' /"/ // , / A^' y - ^ ^ r .o / ` -Z S 2 C J-, X : iJ ' /Wtcr 0 \J N o r U. 77, =|-/ ^ : 7 J ^ *A 6 -^ tc -A 7/ f^ - ' -- y C c iy -c ^ u ^ L ^ A Z a ^ ^ A d A ^ u y k ^ v - tK / j . v-e, # i- i-- "Civ -t ,^rj; s X' ^ Z & A c A jk *. 7/ // z> -C i r' rZ U L^ -^ L . > jis u 'c ^ -L . J A . .-V--3-s. A A ^ A y d ^ ^ Jy O s L S o < r -0 ^ > C d y ^ A ) .s J u - y J -A J 'lL. A A ^ A ^ A ^ X .^ . )" . ' /A ^ - '* ^ 7 ' 'K r ^ P d J / 'X-iSC-'? 77" A s t y r . ' - t L - j C * - . t ? - J - . y (? '-*'(? -C . -c^f Z:- . < . i ' n 7 7 c ^ t i '^ / 'c S '-}-! y ,.v^<--*-*-<J_ C f^ y r-i-'iC * / . 3 c .^i f'c - ^ K - / J < z y - & o i-- Protected Document-Subject to Protective Order ` i - ''-(`_P^r^\f '. J ) / / / 'J a s .;* * * C o \ - C -V JNJ 000682902 FILE NAME: Johnson & Johnson (JAJ) DATE: 1971 July 28 DOC#: JAJ089 DOCUMENT DESCRIPTION: Memo RE Barry Castleman Letter Requesting Asbestos Health Information -- isasa. * 0 I i % \ i > i \ i t } I i 4 i i 1 1 \J V Subject: Asbestos I n q u ir y -- Mr. Barry Castleman EC E1VE D New Brunswick, N.J. J u ly 28, 1971 Dr. T . H. S h e lle y: JUL 2 1971 T,H. SHELUS Jack W alco tt has asked me to d i r e c t the attached l e t t e r from Barry Castleman to you. Mr. Castleman is in the Department of Environmental Engineering at Johns Hopkins U n iv e r s it y . From the tone o f t h i s l e t t e r , i t seems c le a r that Mr. Castleman has s c i e n t i f i c knowledge f a r beyond the normal type o f in q u iry we have received from the p u b l i c . The in q u ir y appears to re q u ire a more s c i e n t i f i c response than we have been using in handling consumer correspondence. T h e r e f o r e , we b e l ie v e t h a t t h i s l e t t e r should be handled by someone in RS-D. Before the response is sent to Mr. Castleman, i t should be checked wi th L a rry F o s te r . Thanks very much f o r your h e lp . j ' m T / i G. F. T y r r e l l GFT/lm : At tachment cc: Mr. J. T. D ettre ,,> M r. L. G. Foster D r, R. A. F u l l e r ; M r. R. J. Howland Mrs. D. Matsu Mr. J. C. Walcott i Protected Document-Subject to Protective Order JNJ 000682901 DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATION WASHINGTON, D.C. 20204 April 6, 1972 Hr. 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 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. 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, Enclosures Assistant Director for Medical Review ^ Division of Colors & Cosmetics Technology Office of Product Technology AptriX 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 asbestos 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 U.S. government agency which has responsi bility for requiring labeling of hasardous 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 uajor constituent in cosmetic powders and perfumed vaginal spsays (its use In dusting surgical g&eves 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 t Asbestos1' 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, ate.) - will remain. Correct Food luid Cvif' A d m in istr a tio n Apr 13 33, l7' ?a sr two rx If I a; vronrs but isn't this the responsibility of the T`ood nmi '-rue /'dmlul Stratton? very trul" 'fuurs, S tC /cn a /3 J ) C ^ 'arry T . Cattleman T-aciiniea.1 rusrvtcus Section `Hvision of Air Pollution sod Indus trial t e z i n n e Marea of Favi roanental Servie CC: Senator Charlea M. Mathias Representative Paul S. Sarbanes J X a . L & TM *Z a H . - -1 *4 D w v LA**d f * A' ' & U t *K 4 4 v -& c -- / / f 1 30$ ^ y ^ t 3 / /??*- ^ & *n -0 > = -tt^ Lc -d ^ ' J j e - M * , - ^ 1 / ^ , a - * ^ .y ^ ,_ Jl~ 2 . s t s o g , - U v ---- ->'. ^ - t - L L Q ^ . ^ L*4 - g ' f / c ~ a O L-t-~ --< *-n ^ c ^ !-a --<s~>, ~ -a C t-r ^ ^ 4 _ s & i/ e - jf L e *- ^ d j . Cs*-- J U ^ L z - m - C j C -<s-?cr~ ($!>- 9 ^ -s 4 i p . ^ - ^ t * - -> a -e ^ < *- & -> _ . t-ts ,'v' ~ e *i. s O l , * l2 4 *Z 4 y & ? !c . <A-*-t < cuas -uz<x^i&* ~ytt*e> LC < - 0 O 5 ^ e d b u < % L 3 / q <^V SL^rZ^l^jTTs-^i-TrJ ^ A ^ o ^ x , V U ~ ^- * * y t * ? & ~ y ? -'*. * - ' ^ < Y ' J2 i^ I - o ^ c j ^ ' -^ e > - ^ y ^ _ j ^ / ) ^T^t^C-^V- ^ C t^ O L ^ s S & L t~ & 0 b O O n X ~ , J '^ 'V x ^ t ^ a . 's^l-O *& le 0 * ^ t s & -O & Z L . TU . /&P -- yt~<=> ~ 4su L se > !e d ? L ^ a . ~scr&&- ^^a^et ~ & 7C /P & c u < s t4 . & ' "Z2> ^e^t<L /-^u -*-*-9^ -^ y 3 - - ^ ^ e c ^ c *> - ( > * C jto o a ^ a , 7^ too c x ^ -r ^ s *u e *c & --i*o i. f * <& / y/*^-&i.sy. 's - ^ ~ s C t f & - t 2 ! / $ ^ s \ - O l / ' S fr ts l , 7 c > ^' Q *~ is 6 -lr-c < > c ^ <5l_- ^4^l<^ s\ 7 f ?6^ ? 7 ^ ' & t d s *-^ y ^u-e-c-^-^.'^ 'S&ctsf*' /?t<^' y D O M E S TIC O PE R A TIN G C O M PA N Y N E W B R U N S W IC K , N. J. August 10, 1972 Mr. B arry I. Castlem an 305 W est Biddle Street B altim ore, M aryland 21201 D ear Mr. C astlem an: This is in reply to your letter of August 3. Since the inform ation you req u est is Largely m edical in nature, I have forwarded it to Dr. H ildick-Sm ith, D irector of C linical R esearch. Dr. H ildick-Sm ith is presently on vacation, but I am certain he w ill w rite to you shortly after his return. S in c e r e ly , mf cc: Dr. G. H ildick-Sm ith D irecto r Central, R esearch Laboratories Im w n J jjv iv M o n Subject: M r. B arry CastLeman's letter re T alc-A sbestos New Brunswick, N.J. A u gu st 10, 1972 D r. G. H ildick-Sm ith 1i The attached re info on ta lc to x ic ity is s e l f exp lan atory. I rea lly think this dem ands a m ed ical an sw er and would a p p re ciate your handling. T . H . S. mf att. - cc: Mr. J. T. Dettre Mr. L. G. F oster Dr. R. A. F uller Mr. R. F . Kniffin M rs. D. Matsu D r . W. N ashed r Mr. R. C. Stites RECEIVED AUG 111972 W. NASHL-IO JOHNSON & JOHNSON 1 Protected Document-Subject to Protective Order 1 Of 1 JNJ 000261178 Pltf JNJ 00038491 CHARLES McC. MATHJAS, JR, MARYLAND 'J&tnxieb 4>euc*ie WASHINGTON. D.C. 20510 June 15, 1972 REPLY TO; 1616 F ederal B uilding 31 HOPKINS PLAZA B a l t im o r e , M a r ylan d 2120T (3 0 1 )-9 6 2 -4 8 5 0 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 2120b 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 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 le tte r of April 20 concerning asbestos-containing products. The Food and Drug Atfcvlnlstration 1s aware of the recent concern over the presence of asbestos-form particles in ta lc which may be used in food products. Since there is some d iffic u lty in Identifying asbestos 1 n talc because o f their chemical sim ilarity, we are now in the process of evaluating the available analytic procedures for determination o f asbestos in ta lc . However, in the meantime we are moving ahead with analysis of products containing ta lc , with existin g methodology, for the presence o f asbestos-form particles. We are attempting to determine the degree o f exposure by the average consumer to products containing these substances. We are also preparing a draft for a proposed provisional regulation for the use in foods of ta lc which is free o f asbestos-form particles. Funds for animal studies on the toxicological e ffe cts of talc have not been available. A memorandum o f need is being developed to ju stify the needed funds for contract feeding studies on s ilic a te s , including talc. The Bureau of Product Safety of the Food and Drug Administration has reviewed the HIQSH document "Criteria for a Recommended Standard . . . Occupations! Exposure to Asbestos" and the quotation Mr. Castleman gave from page V-3. We are unaware of any type of asbestos product, Intended for use in the household, which could be expected to give r ise to such concentrations of airborne fibers that Its use would overwhelm the clearing mechanism. Since long-term exposure to levels contemplated by the standard would not be expected to overwhelm the clearing mechanism, the level contemplated by the quoted passage must be much higher. Page 2 - Honorable Charles NcC. Mathias, J r, FDA has at the present time no sp ecific regulatory actions underway except the prohibition of use of asbestos as a component of general use garments. We are continuing to explore the p o ssib ility of hazard from other uses of asbestos-containing products in the home and methods for control of such hazards as are discovered, including In our consideration labeling, construction criteria such 4$ resin-bonding, and i f i t should become necessary * banning sp ecific as yet unidentified products, to control likelihood of release of airborne fibers of asbestos. Thank you for your in terest. Please le t us know i f we can be of further assistance. Sincerely yours, Enclosure Constituent's letter Gerald F. Meyer, Director Off1ce of Legislative Services cc: Your Washington Office M arch 7, 1972 N E W B R U N S W IC K . N. J. M r. Barry C astlem an 305 W. Biddle S treet B altim ore, M aryland 21201 Dear M r. C astlem an: F ir st, I m u st ap ologize for the delay in replying to your inquiry about JOHNSON'S Brand Baby P ow d er. Your card w as sen t in in ter-office m ail with som e correspondence in re-u sa b le envelope. The other m a il w as taken from the envelope w hich w as then placed in a stack to be used again. U nfortunately, it w as not used again until this w eek, and your card w as re-d isco v ered at that tim e. To answ er your question, Johnson & Johnson takes great care in the form ulation and production of a ll its products. In the c a se of JOHNSON'S Baby P ow der, the talc co m e s from our own m in es, sp ecifica lly selected for the quality of their ta lc. This high-grade talc is p rocessed through repeated "washings" in order to fr e e it of im p u rities. Under carefu l a n a ly sis by independent ex p e r ts, the fin ish ed product has b een shown to be free of a sb estos. Thank you for your in te r e st in Johnson & Johnson products and p le a se fo r g iv e the d ela y in rep lyin g to your ca r d . S incerely; SS:ev Steven Sawchuk, M .D . A ssociate D irector of C linical R esearch March 22, 1972 food and Drug Adminla fcration Department of calth, Education and Welfare 3600 Fishers Lan Rockville, 'iaryland 20S52 Attention: fir. John F. Palmar, M.i)., Deputy Director Sureau of Drugs Dear Dr. Palmer; 1 am writing to find out what the FDA is doing to research the suspected carcinogenicity of talcs (with and without tretsollte asbestos); and what m a s u r e s are being taken to safeguard the public against exposure to asbestos-containing consumer products (building material, fabrics etc.). As you probably know, the National Institute for Occupational Safety and Health has Just published the document Criteria for a Pecotasended Standard ..... Occupational Exposure to Asbestos." The closing remark in section V, Development of Standard, reads, Thus, the toffet aftx several decades of a one-time acute dose of limited duration which overwhelms the clearing mechanism, and is retained in the lungs, m y be as 'harmful [carcin ogenic] as the cumulative effect of lower daily doses of exposure over manv years of work. Asbestos is known to have been used in over 3n00 applications including filter media for production of drugs, d m a p cigars, home boiler Insulation, heat-resistant clothing, paper products, sprayed fireproofing insulation, and numerous building products. Talc la aineralogically 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 talc deoosits. Recent publications have pointed out the possibilit of talc causing ovarian cancer and stomach cancer (in Japan). However, ae far as I know, no one has been able t o firmly establish talc m being either carcinogenic or harmlessThe most disturbing use of talc I know # is in recently-marketed fminin byglana spray*. Also, so, cosmetic powder* have strikingly high, fibrous content. Any information you can send about the FDA's activities on asbestos and talc will bo deeply appreciated. Sincerely yours, BIC/cms ce-, nr. Earl Meyers Mr. Jerome boldscoin Barry I. / Hastleraan Division of Air Pollution and Industrial Hygiene Bureau of Environmental Servicon 'CMENr DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATION W A SH IN G T O N , D C 20204 May 2, 1972 Mr. Barry Castieman Technical Services Section Division of Air Pollution and Industrial Hygiene Bureau of Environmental Services Baltimore County Department of Health Maryland Avenue and Hi lien Road Towson, Maryland 21204 Dear Mr. Castieman: Thank you for your letter of April 25, 1972, and the enclosed material. During the past six months various members of the Food and Drug Administration have had a number of conferences with Dr. Selikoff and his staff here and in New York. We have collected and reviewed about one hundred papers on asbestos toxicity. Largely because of the long time tag and also because of a reluctance to allow human exposure to a potentially toxic substance the dose response relationships of asbestos toxicity are undetermined. The industrial tolerance rests on rather shaky ground, however it will be 20 to 40 years before it can be determined whether it is too high or too low. In the meantime, tremoiite, because it is not widely used, does not have the background of proven injury as does chrysotiie. I have talked with some experts who feel that tremoiite is iess hazardous than other forms of asbestos. This point can not be settled by argument. With regard to cosmetics, the Food, Drug and Cosmetic Act, which governs our activities states precisely that products must be shown to contain a harmful or deleterious substance before they are subject to action, i.e. The FDA must be prepared to prove a cosmetic is hazardous before it can act against it. Condoms and diaphragms are dusted with ta>c. Henderson et al (Henderson, W. J ., C. A. F. Joslin, A. C. Turnbull and K. Griffiths, i Page 2 - Mr. Barry Cast lemn Talc and carcinoma of the ovary and cervix, J. Obstet Gynecol Br. Commonw, 78:266 - 272, (March), 1971)] were able to demonstrate talc, but not asbestos within malignant tissue. Unfortunately, they also noted talc particles in normal tissue. 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 contracep tives may have been examined with t a x dusted gloves so that there may be some problem in developing a control group. Sincerely yours /Assistant Director for Medical Affairs Division of Colors & Cosmetics Technology Office of Product Technology VI Phons Nusiber 301-494-3775 *7 10, 1972 Dr. Albert Fritsch Canter for Science in the Public Interest 1346 Connecticut Avenue, N.W. Washington, D.C. Dear Hr. Fritsch: X was referred to you by Ken Lassen. I ant Interested in research on the adverse effects on health of asbestos end talc, In particular carcinogenisia. Ken said that your center performs action-oriented investigations and you might be working on these topics now. As far as I know, no one has yet 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 tresaolite 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, perfused vaginal sprays, etc. My correspondence with FDA indicates that they arc doing a minimal job (analysing talcs for asbestos) about regulating both asbestos and talc in consumer goods. I would like to know of ways to get them "interested." In my spare hours hert, 7 have reviewed seme of the literature on cervical cancer epidemiology. X also understand that soma, but not all, prophylactics are dusted with talc In processing and packaging. Dr. Abraham Lillenfeld at the Johns Hopkins School of Hygiene has an Interest in talc also, and X hope to work out some kind of study with him soon. Please let me know your interest and activities In the subjects of asbestos and talc. 1 would be glad to come down and see you if you think it worthwhile. Hy best wishes ir your work. Sincerely, BC;dh Barry Castleraan 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 fco 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, AiDerr j. tritscn VI May 15 1972 Mr. Paul 5. Sarbanes Congrats of the Unitad States Souse of Representatives Washington D.c. 20515 Dear Mr. Sarbanes: Incloeed is wy eontinned correapandance vieh Dr. John Candy of the food and Deng Administration, on the subject of regulation of asbeatoeend tale-containing consoner goods. One thing is clear to ne at this point: the FDA la either unable or unwilling to taka regulatory action; and, I don't think wa should have to await another 40 years of mortality studies to know the degree of haaard to which the public is now being exposed. Mr. Serbanea, I urge you to use your influence to see that something * ie dene boot this situation. Of course, I will be glad to discuss it at length with you or meabers of your staff at your convenience. Sincerely, harry Ceatleaen Technical Services Section Division of Air Pollution end Industrial hygiene Bure) of Baviroamental Services BCid| S nel. N E W BRUNSWICK. N J. Pg9P> Septem ber 19, 1972 Mr. Barry I. Castlem an 305 W est Biddle Street B altim ore, M aryland 21201 Dear Mr. Castlem an: I am taking the liberty of replyii g to your letter dated August 3, addressed to Dr. T. H. Shelie D irector of our Central R esearch L aboratories. F irst, et m e express our appreciation o f your bringing to our atten io n your concern about the p ossib ility that talc by itse lf m ay be carcinogen. A s we m a r k e t ta lc w e have r e a l co n ce rn about ny p o ten tia l h arm ful effects it m ay have and have been monito ing on a continuing b a s is the w o rld lite r a tu r e on the b io lo g ic :|.l a c tiv ity o f ta lc . We a re p r im a r ily in te r e s te d in d eterm in in g rhether the c o s m e tic u se of talc can cause any harm ful effects and at this tim e have no reason to b eliev e that talc alone w ill iduce n eop lastic changes. The publication by K leinfeld (Ar ;h. E x p er. H ealth, 14: 663-7, 1967) that you m entioned in your ' etter is fam iliar to us and, as you know, reports on the inciden ;e of pulm onary cancer in m in e r s w ork in g in ta lc m in e s w h ich c< ntained tr e m o lite and se r p e n tin e . I am subm itting som e points^wh ch support our RSMtion that pure talc is not a carcinogen which m ay be of in terest to you. 1. The m onitoring of ad verse ffects relating to the com m ercial use of a prqduct that has been m arketed for over 70 years by us and used co sm etically for centuries. 2. The continuing r e v ie w o f th< w orld lite r a tu r e on talc shows that it has been t sed therapeutically when introduced into the pie Ural ca v ity , has been Mr. Barry I. Castlem an - 2- Septem ber 19, 1972 1 introduced into the peritonea] cavity from ruptured su rg ica l gloves and has been resp ired by in d u strial w ork ers. In both the pleural cavity and the peritoneal cav.ty talc produces lo ca l fib ro sis in the tissu es end to date we have not been able to find any repc rts of cancer in the extensive m edical liter a tire on this subject. E x c e ssiv e exposure to talc c iu s e s ta lc o sis in m in ers, and I know of no d a ti to indicate that cancer o f the lung occurs in such m in ers exposed to talc free of asb estos. * 3. Controlled studies have been conducted in h am sters in which talc w as introduced into lungs and pleura and the resu lts showed no cancer developm ent when the anim als w ere followed for their life. T hese data w ere in contrast to resu lts obtained when asb estos was used in place cf ta lc. A paper on these studies w ill shortly be reported in the m edical lite r a tu r e . 4 . In o rd er to co n firm the findings rep o rted in *31, two sep arate, exten sive anim al studies are being con ducted independently in whic h the anim als w ill inhale talc for differen t tim e perio is and w ill be follow ed for their lifetim e and then exam ined h isto lo g ica lly . Your com m ent concerning the follow up o f ta lc m in ers to determ ine the cause of their death is per' inent but is tim e consum ing, and the num bers involved are rela tiv ely sm a ll. H ow ever, in order to obtain ep id em iological data m ore rapit ly, we are currently follow ing an exten sive epidem iological survey of the cause of death in a large group of ind u strial w orkers expose 1 to talc with a view to d eter m ining w h eth er th ey d iffer fro m other ap propriate p opu lation s. In addition we are attem pting to obtain data on the cau se of death of *Van O rstrand, H .D . : Talc pneum oconiosis, C hest, 58(1):2, July, 1970 M r. B arry I. Castleman -3 ) Septeraber 19 1972 ta lc m in e r s and d e te r m in e i f th e c a u se o; d eath d iffe r s fr o m oth er populations. I am hopeful that the com m ents [ have subm itted w ill be of a ssistan ce to you. We appreciate your in terest in w riting to us and look forward to supplying you with pertinent published data as they becom e available. Sincerely yours, G H S.'M M S A 'W ' G avin H Lidie imth, M. D . , F . A . A . P . D irecto: C linical R esearch ENVIRONMENTAL DEFENSE /O p N FUND 1276 1525 18th XXtftN 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 regula tion Asbestos Particles in Food and Drugs, 38 Fed. Reg. 27076-'81, Sept. 28, 1973.________________ , Dear Sir: We attach the comments of the Environmental Defense Fund and the Center for Science in the Public Interest concerning the proposed regulation cited above. CSPI is a Washington-based non-profit corporation composed of scientists dedicated to public interest research and advocacy ,, on public health and environmental issues. EDF is a non-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, Lucile F. Adamson, Ph.D. Environmental Defense Fund Enclosure Barry astleman Center for Science in the Public Interest OFFICES IN: EAST SETAUKET, NY (MAIN OFFICE); NEW YORK CITY (PROGRAM SUPPORT OFFICE): WASHINGTON, DC; BERKELEY, CALIF. Thla paper la recycled to protect the environment. ^ JNJNL61JD00022535 (202) 332-6000 CENTER FOR SCIENCE IN THE PUBLIC INTEREST 1779 Church Street, N.W, Washington, D.C. 20036 June 1973 Food and Drug Administration Bureau o f Drugs OTC Drugs Products Evaluation 5600 Fishers L a n e , Rockville, MD 20852 Staff (BD-109) OTC Drug Review Informalion-"Contraceptives and Other Vaginal Drug Productsi IV. Human Safety Data on Talc A. Individual Active Components 5 Pertinent Medical and Scientific Literature. a. Hendersons- V/.J. et al, "Talc and Carcinoma of the Ovary and Cervix," J. Obstet. G y m Brit. Comm,, 2 3 * 266, 1971 b. Blejer, H.P. and Arlon, R . , "Talci a Possible Occupational and Environmental Carcinogen^" J. Occup, Med,, ljj? 92, 1973 VI, Summary Statement-- Talc is commonly used in the manufacture and packaging of condoms and diaphragms, Henderson's study revealed the presence of talc deeply imbedded in the majority of primary malignant ovarian and cervical tumors examined. The fact that these researchers could not find 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 asbestos- containing talcs in the preparation and packaging of foods (Federal Register v, 37 no. 157)* It would OTC Drugs Products Evaluation Staff-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 FDA'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 Castleman Michael Jacob$on y November 13, 1973 Mr. Barry Caetleman Center for Science in the Public Internet 1779 C hurch S tre e t, N. W. Washington, D .C . 20036 Dear Mr. Caetleman: Thank you for your letter of October 30, 1973. As requested, we are attaching a copy of our Talc Safety Literature Review which has been recently updated. I hope you will find it useful. Very truly yours, JOHNSON & JOHNSON wn/cw W. Nashed, P h .D . Director of Science Information Attach: 1 vol. Mr. D. Clare Dr. R. Fuller Dr. G. tiildick-Sm ith Mr. D. D. Johnston Mr. J. Melton Dr. T. Shelley Mr. H. Stolzer Dr. D. Petterson Protected Document-Subject 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. N a sh e d , P h .D . D irecto r o f S cien ce Inform ation J o h n so n and J o h n so n Company New B r u n sw ic k , New J e r s e y Dear Dr. N ashed: I read w ith in te r e s t a copy o f your in form ative b o o k le t, "Talc S a fe ty - A L ite r a tu r e R eview ", w hich was su b m itted to th e Food and Drug A d m in istr a tio n t h i s March. I w ou ld be g r a t e f u l i f you w ou ld s e n d me a c o p y . S in cerely yours, tA A y B a rry /Cusa stle m a n Protected Document-Subject to Protective Order 1 Of 1 JNJ 000261166 Pltf JNJ 00038480 ENVIRONMENTAL DEFENSE O P ) FUND 1294 1525 18th STREET, NW, W ASHINGTON, D.C. 20036/202 333-1495 January 28, 1974 Hearing Clerk Food and Drug A d m in istra tio n Room 6-86 5600 F is h e r s Lane R o c k v ille , Md. 20852 RE; FDA P rop osed Rulemaking i rela tin g to Asbestos P a r t ic le s in Food and Drugs (F.R. S ep t. 28, 1973) Dear S ir : The ab ove-n oted p ro p o sa l in v it e d comments from in t e r e s t e d p a r t ie s on or b efo r e December 27, 1973. The E nvironm ental D e fen se Fund and th e C en ter fo r S c ie n c e in th e P u b lic I n t e r e s t d id f i l e such comments b e fo r e t h a t d a t e . S in c e t h a t tim e , we have had th e o p p o r tu n ity to c o n s id e r th e Comment o f 1 2 /2 1 f i l e d by J o h n s-M a n v ilie (J-M) on th e same p r o p o s a l. As a r e s u l t , we a re now su b m ittin g a su p p lem en tal comment w ith th e hope t h a t i t , although la t e , can be considered as w e ll. T h is comment can be summarized by two s ta te m e n ts : a) We do n ot o b jec t to th e d escrib ed use o f a sb esto s-c o n ta in in g t a lc fo r p itc h c o n tr o l in food and drug papers i f i t i s shown th a t such t a lc does not m igrate in to food or drugs w ith which th e pa per i s in c o n ta c t; and b) th e use o f a d d itio n a l a s b e s t o s - c o n t a in ing ta lc fo r b rig h tn ess f i l l i n g or any other purpose should not be a c c e p ta b le in food and drug w rapp ings. There a re a number o f s ta te m e n ts in S e c t io n 3 o f t h e J-M Comment (H ealth Hazard o f I n g e s tio n ) to w hich we would ta k e str o n g e x c e p t io n . We do n ot w ish any o f th e s ta te m e n ts w hich we make h ere to in d ic a te agreement th a t a sb esto s in g e stio n can be assumed to be h a r m le ss. We do n o t b e l i e v e t h a t such an assu m p tion i s j u s t i f i e d . However, th is q u estion i s n ot re le v a n t to any u se o f t a lc which does not g iv e r is e to asb estos in g e s tio n . OFFICES IN; EAST SETAUXET. NV (MAIN OFFICE); NEW YORK CITY (PROGRAM SUPPORT OFFICE); WASHINGTON, OC; BERKELEY. CALIF.; DENVER. COL J&J-0134952 Protected Document-Subject to Protective Order JNJ 000288719 1 of 3 Pltf JNJ 00047581 # 2 1295 . We have c o n s id e r e d th e m atter o f t a l c u se i n th e m anufac t u r e o f paper u sed f o r food p a ck a g in g . J-M s t a t e s t h a t t a l c w hich c o n ta in s up t o 5% t r e m o lit e by volum e and i s u sed f o r p it c h c o n tr o l becomes "locked in to p la ce in th e paper" and w i l l not m ig r a te in t o food w ith w hich i t i s in c o n t a c t . J-M f u r t h e r main ta in s th a t due to t a l c 's unique su rface p r o p e r tie s , no eq u iv a len t s u b s t i t u t e s are known and t h a t s u r fa c e a c t i v e a g e n t s , i f used a s an a lte r n a tiv e to t a l c , are a cause o f p o llu tio n a t p u lp m ills. We are now making our own a p p r a is a l o f t h e en v iro n m en ta l im pact o f t a l c and n o n -ta lc system s fo r p itc h c o n tr o l. However, i t i s our prelim inary opinion that the advantages o f the use of t a lc for p itch co n tro l need not be s a c r ific e d i f , as J-M 's t e s t s in d ic a t e , th e incorp orated t a lc does n ot m igrate from papers to food. I t i s our understanding th at t a lc fo r p itc h -c o n tr o l i s added d u rin g p u lp in g in amounts up t o 1.5%, w ith fu r t h e r a d d it io n o f a3 much as 2% durin g paper m aking. T hese f i g u r e s w ere g iv e n by J o h n s-M a n v ille in t h e i r December 2 1 , 1973 Comment t o y o u . If testing by procedures approved by the FDA does establish that no tremolite will migrate from'paper to any food or drug during forseeable conditions of use, we would not obiect to this use of talc containing up to 5% tremolite by volume, in the amount; noted above, for the purpose of pitch control. Use o f t a l c fo r o th er purposes in food and drug wrappings should not be a llo w ed . For example, Joh ns-M an ville a ls o s e l l s a 20 t o 30% t r e m o lit e t a l c fo r u se as a " fu n c t io n a l f i l l e r " in paper m aking, and sa y s th a t such f i l l e r i s used l i t t l e in making food p a p ers. Normal r a te s o f t a l c a d d itio n fo r t h i s purpose exceed th e combined amounts used in p it c h c o n t r o l, and s e r v e o n ly an a d m itte d ly c o sm e tic p u r p o se . Where m an u factu res r e q u ir e such b rig h ten ers fo r food or drug wrappings, s u b s titu te s fo r t a lc such as titanium d ioxid e can be used. As th e u se o f 5 t o 15 p e r c e n t t a l c c o n ta in in g 20 t o 30% tr e m o lite c o n s titu te s a r e la t iv e ly m assive amount o f tr e m o lite a d d ed , we b e l i e v e t h a t th e u se o f t a l c fo r b r ig h t n e s s f i l l i n g in food and drug papers should be p r o h ib ite d im m ed ia tely . I t is u n lik ely th at papers with such high ta lc loading would com pletely r e ta in th e ir t a lc during th e te a r in g , ab rasion , and re p e a ted f o ld in g s to which some food p ap ers are s u b je c te d . J-M states that the use of such high-talc 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-Subject to Protective Order 2 Of 3 J&J-0134953 JNJ 000288720 Pltf JNJ 00047581 3 '296 We a re u n ab le t o comment on th e a c c e p t a b i l i t y o f ta lc -^ tr e a te d r e c y c le d p aper s i n c e we have no in fo r m a tio n a s t o how much t a l c i s retain ed a fte r the w aste pulp stock is reclaim ed , whether i t i s more or l e s s s e c u r e ly "locked in " than t a l c added fo r p itc h c o n tr o l, and t o what e x te n t r e c y c le d paper i s u sed fo r d ir e c t wrapping o f fo o d and d ru g s. We are aware t h a t r e c y c le d paper i s a p t t o c o n ta in o th e r con tam in an ts ( i . e . PCB' s)w h ic h can make i t u n s u ita b le fo r food and drug w rapping. We u rge PDA t o c l a r i f y th ese p o in ts b efore approving th e use o f recy cled paper for d ir e c t c o n ta c t w ith food and d ru gs. S in cerely yours, L u c ile F . Adamson, Ph.D. E nviron m en tal D e fe n se Fund LFA/BC:mew ] cen ter for Science in the Public In terest Protected D o c u m e n t-S u b je c t to Protective O rder 3 of 3 J8.J-0134954 JNJ 000288721 Pltf JNJ_00047581 J u * 3110 Main Dining Hall College Park, Maryland University of Maryland (301) 454-5601 MARYLAND 20742 PUBLIC INTEREST RESEARCH April 17, 1975 GROUP, INC. Dr. Gavin Hildick-Smith, M.D., F.A.A.P. Director of Clinical Research Johnson 6e Johnson New Brunswick, New Jersey 08903 Dear Dr, Hildick-Smith: Several years ago I received a letter from you (September 19, 1972) in response to my concern that talc per se may be a " c a r c in o g e n . You r e fe r r e d to s e v e r a l o n g o in g s t u d ie s , 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 talc-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. (2) separate, extensive animal inhalation studies with talc (3) an extensive epidemiological survey of the cause of death in a group of talc-exposed workers (4) other studies on the mortality of talc miners. I hope this request is not overly burdensome. As one who is sometimes asked about the health effects of- talc, I try to keep as up-to-date on the literature as possible. S in c e re ly , BC :ljk Barr/ Castleman Environmental Engineer Protected Document-Subject to Protective Order 1 of 1 JNJ 000261538 Pltf JNJ 00038617 M arch 17, 197 5 Page 53 FOOD CHEMICAL NEWS FDA DELAYS ACTION ON ASBESTOS-CONTAINING TALC IN FOOD The Food and Drug A dm inistration on M arch 14 s a id th a t c u rre n tly -a v a ila b le inform ation does not warrant a ban on asbestos-containing talc in foods, acknowledging that it will delay any actio n on its long-pending proposal to in stitu te such a ban (See FOOD CHEMICAL NEWS, Oct. 1 , 1973, Page 37). At the sam e tim e , FDA w ithdrew its p ro p o s a l to tie the " g e n e ra lly re c o g n iz e d a s s a fe " use of talc in food-packaging paper and paperboard to the absence of asbestos-form p a rtic le s . The agency a lso reaffirmed its d e cisio n not to propose lim itations on use of asbestos-containing filters in food and beverage processing. The agency did issu e a regulation dealing w ith asbestos-form particles in drugs for parenteral in je c tio n , and a t the same time d is c u s s e d at length the comments filed on its proposals dealing w ith talc in food, drugs, and in packaging (See FOOD CHEMICAL NEWS, O c t. 2 2 , 1973, Page 18; D e c . 3, 1973, Page 2; D e c . 10, 1973, Page 3; D e c . 24, 1973, Page 20; Jan. 7, 1974, Page 30; Jan. 14, 1974, Page 30; and Feb. 18, 1974 , Page 16). FDA n o te d th a t i t p l a n s , in c o n ju n c tio n w ith o t h e r a g e n c i e s , " e x te n s iv e e x p erim en ts to determine if long term exposure to ingested asb esto s fibers represents a definitive hazard to human h e a lth ." Until the study is completed or other data are available, the agency concluded "that a prohibition of the use of asbestos-containing filters in the processing of food and beverages, and of asbestos-containing talc as a food or food additive or in drugs or drug ingredients is unwarranted due to lack of sufficient d ata, " I n d u s try I n v e s t i g a t i o n s Urged by FDA H o w e v e r, FDA urged m a n u fa c tu re rs "to i n v e s t i g a t e a ll m e a n s of e lim in a tin g the u s e of s u c h f il te r s a n d t a l c , and to k e ep the FDA inform ed a b o u t c h a n g e s in form ulation and processing of this type." As e x p e c t e d , FDA d e c id e d to d e la y a n y f in a l r e g u la tio n s for ta lc u n til "an a c c e p ta b le method for determining the presence of asbestos particles can be developed for this su b sta n c e" (See FOOD CHEMICAL NEWS, Feb. 17, Page 32). The agency said it is actively pursuing research on methodology. FDA did not a g re e w ith com m ents "th a t the d e s ig n a te d o p tic a l c ry s ta llo g ra p h ic m ethod is unreliable when used by those experienced in the a rt," but did recognize "that an effective compliance method must have greater utility and acceptance than indicated by the comments on the proposed method." M o s t of th o s e w ho com m ented did no t a c tu a lly u s e the p ro p o se d m eth o d , FDA s a i d , but reflected their general experience with optical crystallography, or "a personal preference for other analytical m ethods." The proposed method w as supported in none of the comments. M ost com m only-expressed objection was the difficulty in using the method. A collaborative study by members of one trade association resulted in incon siste n t re su lts, and four of the ten participants could not use the method, the agency said. M arch 17, 1975 Page 55 FOOD CHEMICAL NEWS "Although detection w as limited by the bulk of a sh recovered from other products , such as fresh wrapped and frozen meat, dry packaged macaroni, dried milk, rice, and corn flakes, the comment also demonstrated that these products contain less th an 10 p . p . b . a s b e s t o s u n d e r t e s t and m arket c o n d i t i o n s , " FDA s a i d . Concluding that the sa lt study "represents a p ractical upper limit of migration of a s b e s t o s from f o o d - c o n ta c t p a p e r and p a p e r b o a r d ," FDA e x p la in e d th a t th e c o n c lu s io n "is based upon consideration of the extreme abrasive nature of salt as compared to otherdry fo o d s, and the unusually high tremolitic asbestos content of the test paper (6%), a s com pared to re p o rte d le v e ls of u s e ( 0 .0 2 - 0 .4 % ) in fo o d - c o n ta c t p a p e r and paperboard." FDA d e la y e d " th e p ro m u lg a tio n of a n y re g u la tio n on the p ro h ib itio n of u s e of a s b e s t o s filters for the preparation of foods and nonparenteral drugs until more reliable data can be obtained on the background concentration of asbestos in drinking water and the role of asbestos filters in regard to the addition of fibers to ingestible products." The agency had stated in its proposal that it had decided not to issue a regulation governing the use of asb e sto s filters in food and beverage processing. Some comments urged that use of filters be regulated on the b a sis of a lack of evidence to show that the in g e s tio n of sm all am ounts of a s b e s to s is s a f e . FDA said : "The Commissioner agrees that uniform and co n sisten t regulations should be adopted on an industry-w ide b a sis . In this in stan ce, the lack of available reproducible method ology for determining asbestos-form fibers in beverages and other foods led the Commissioner to propose the regulation of talc before handling other related m atters. In any event, the comment has now become moot since the Commissioner has decided to delay a final ruling on talc as a direct food or drug ingredient. " FDA a l s o s a id th a t " n e ith e r the a v a il a b le d a ta on the a d d itio n of fib e rs to foods and nonparenteral drugs by use of asb e sto s filters nor the data on the asb e sto s content of municipal w ater are sufficiently reliable to permit promulgation of regulatory controls a t th is t i m e . " N oting a s b e s t o s c o n te n t in some m u n ic ip a l w a te r -s u p p lie s , FDA s a id a Canadian study indicated that asbestos content of beverages i s ; comparable to the background levels in areas of'the U. S. Noting its analysis of the comments, a re-review of the methodology, and the "contro versial nature of evidence to dem onstrate the hazard to health presented by ingestion of the amounts of a sb e sto s fibers normally to be expected in talc used in food or drugs, or in food or drug packaging containing talc, or in beverages, other foods and nonparentere d ru g s p re p a re d w ith the u s e of a s b e s t o s f i l t e r s , " FDA c o n c lu d e d th a t -- " . . . The promulgation of regulations on the lim itations or prohibition of the use of asb esto s filters for the preparation of foods and nonparenteral drugs and of the amount of asbestos fibers in talc for use in food and drugs or which Call from Dr, Bruce Semple, Johnson & Johnson May 7, 1975 201-524-5025 Semple responded to my letter to Dr. Hi!dick-Smith, to tell me of current studi.es on the effects of talc. There are several reports that will be issued between now and September. Talc miners and millers in Italy. Choser for its pure talc and stable population. Paper preprint will le sent in one month. No difference in mortality between miners nd millers and controls. More pneumoconiosis in contrils, more ir miners than millers (the latfter 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 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 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 vriLth 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 raucous stream and little is retained in the lungs.