Document v6obBOL2L3je8vxMZ088nR78Z

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUDLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATION W A S H IN G T O N , D .C . 20204 O ctober 6, 1971 To: P a r tic ip a n ts in "A sbestos and T a lc " D iscusicm S e s s io n a t FDA on August 3_p 197 X A ttach ed i s a s u g a r y o f om re ce n t D iscu ssio n Sees lux* cm "A&bestos and T a l c ," As warty o f yen I have requested submissions o f de t a i l e d a n a ly t ic a l procedures frees a l l o f the la b o r a to r ie s rep resen ted which perform each work. At th is w r itin g , I have receiv ed m o t , but not y e t a l l , o f the c is t e r ia l re q u e ste d , When the s u b s ic s io n s are com p le te , X s h a ll proceed with the synthesis o f these in to a package which w i l l be c ir c u la te d fo r eor&rsants, / llian k you once again fo r your a s s is ta n c e and p a r t ic ip a t io n . Sin cerely yours / A lfre d Weiss1er, P h ,B ., A cting D irector D iv is io n o f C olors and Cosm etics Techno O ffic e o f Product Technology MEMORANDUM OF A SYMPOSIUM August 3, 1971 ASBESTOS AND TALC Held at the Food and Drug Adm inistration 200 "C" S tr e e t, S.W. Washington, D .C . 20204 Moderator: Dr. Alfred W eissler, D irector D ivision o f Colors & Cosmetics Technology SUMMARY The amount o f asbestos fib ers in talcum powder products, and the in halation health hazards associated with th eir presence, are subjects o f current in terest but d iffe rin g reports. At a symposium held on August 3 at the Food and Drug Adm inistration attende by over 40 s c ie n t is t s , physicians and consumers, I t was gen erally agreed that most talcum powders o f major manufacturers are r e la tiv e ly free o f asbestos. Nevertheless, on behalf o f consumers, FDA. is working on the detail o f a laboratory procedure for the an alysis o f asbestos in talcum powders which w ill give consistent meaningful r e su lts. Accurate analyse fo r the amount o f asbestos in talcum powder w ill be obtainable, according to many o f the p a rticip a n ts, only through the use o f a battery o f sp ecia lized instruments and techniques, including x -ra y d iffr m tio n , p o la rizin g o p tica l microscopy, electron microscopy, and electron d iffraction of selected p articles. In addition to extensive discussions o f the a n a ly tica l methods for asbestos used by various lab orato ries, the group also considered such topics as the medics! s ig n ific a n c e o f asbestos and other fib e r s , and the mineralogy o f asbestos and ta lc ore dep osits. INTRODUCTION Dr. W eissler opened the meeting by o u tlin in g some o f the events which had brought the question o f asbestos p a r ticle s in ta lc to the atten tion o f FDA. He indicated that in response to a le tte r from Jerome Kretchmer (Administrt Environmental Protection Agency, New York C ity ) to HEW Secretary Richardson, on June 28, 1971 the FDA was taking steps to in v estiga te the problem o f asbe to particle in t a l c . As a f i r s t step the FDA would lik e to e sta b lish a laboratory procedure for the determination o f asbestos in talcum powder products that w ill give meaningful and consistent r e s u lts . Once the methodology is agreed upon FDA would be in a p o sitio n to determine i f such products on the market contain asbestos fibers. The format o f the meeting consisted o f short presentations by each p a r t ic i pant followed by informal discussions which served to pool the knowledge of the A p e r ts present. l i s t o f the discussion topics is attached. GENERAL DISCUSSION I . Dr. Ross o f the U .S . G eological Survey made the f i r s t presentation. Dr. Ross, a rainerologist, outlined the various associations of asbestos mineral species with t a l c . During th is presentation and the discussion which ensued the follow ing s a lie n t point emerged: a . D efin ition : Asbestos is a generic tcra for a variety of hydrated s i l i c a t e minerals which have one common a ttr ib u te . the a b il it y to be separated into r e la tiv e ly s o f t , s ilk y fiber. Although the name is o rd in a rily associated with those v a r ie tie s which have technologic importance, i t is applicable to a l l mineral which f i t the above d e scrip tio n s. The terra "asbestoform minerals" is perhaps most d escrip tive ( 1 ) . b. The known v a r ie tie s o f asbestoform minerals can be divided in to two main classes on the basis o f th e ir c r y s ta l stru ctu res: serpentine and amphiboles. The sole member o f the serpentine c la ss i ch ry so tile asbestos, which i by fa r the most common o f the agbestoform m inerals. I t accounts for more than 95% o f the asbestos fib e r produced today. There are fiv e recognised asbestoform v a r ie tie s o f amphibole: c r o c id o lite , araosite, an thop hyllite, trem olite, and a c tin o lit e . Although the amphiboles are common rock-forming m inerals, the asbestofona v a r ie tie s are much le$ abundant than ch ry so tile ( 1 ) . c . The em pirical formula o f fclc and ora asb estofom minerals can be represented as follow s: T alc, Mg3 S I4 Oxo (0H) 4 Serpentine Class C h ry so tile , Mg3 S i 2 O5 (GH>4 (1) S p e ll, S . and Lelneweber, J . P . , Environmental Research 2 166-208 (1969 Pag 3 Axaphlbole Class Anthophyllite (Mg, Fe) 7 S lg 02 2 (OH) 2 Treraolite C&2 **85 S ig 022 (OH) 2 A e tin o lite Ca2 (Mg Fe) 5 S i g C>22 (0H) 2 dc I t is not unusual to find large v a ria tio n s in the composition o f a mineral within a r e la tiv e ly small area o f a given deposit. The differences depend to a great extent on the mineralogy involved. 2. Dr. C r a lle y o f the National In s titu te for Occupational S a fe ty and Health spoke on the fibrous content o f cosmetic talcum products. His presentation, centered in part on a paper he co-authored e n title d "Fibrous and Mineral Content o f Cosmetic Talcum Products," Arear. In d u strial Hygiene Associa tio n Jo u rn a l. 29. 350-4 (1968). The follow ing conclusions were made in th is paper; "With the exception o f 4 o f the 22 cosmetic talcum products analyzed, the levels of free s i l i c a , cob alt, n ick e l, chromium, and manganese were generally o f a low magnitude and w ithin a narrow range. I t i s not known whether the four products represent a s i g n i f ican t proportion o f sales in the industry or to what extent the sources o f the t a lc in these four formu latio n s are the same as sources o f ta lc sp e cifie d for use in other talcum products in the com petitive market. The le ve ls o f s i l i c a , chromium, and nickel in these four products are s u f f ic ie n t ly high, however, to be o f concern in th e ir p o te n tia l to cause d isease. . A l l o f the 22 talcum products analysed have an appre cia b le fib e r content, ranging from 8 to 30% by count o f the to ta l talcum p a r tic u la te s , and averaging 19%. The fibrous m aterial was predominantly t a lc but pro bably contained minor amounts o f trem olite, anthophy llite > and ch ry so tile as these are often present in fibrous ta lc mineral deposits. Cosmetic talcum products should be included as a source o f the fib e r s , from which may be derived ferruginous bodies observed in the lungs o f humans. The meaning of the presence of these ferruginous bodies, however, is un certain ." 3. The th ird discussion to p ic on the program dealt with the b io lo g ic a l and medical sig n ific a n ce of asbestos and other fib e r s . Three speakers address themselves to th is to p ic. a . B r. S e lik o ff o f Mount S in a i School o f Medicine outlined b r ie fly the h istory, of fib r o s is 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 o f f i c i a l s there was no apparent Page 4 problem presented to the general population with regard to asbestos. I t was considered at that time to be mainly an occupational problem. He reported that recen tly acquired knowledge has greatly increased his concern over the whole question of asbestos fib e rs in the environment. He f e l t that the new dimension added to the problem was the p o ssi b i l i t y that lung cancer may resu lt even from exposures at less than occupation le v e ls . b. Dr. BildickSm itk, D irector of C lin ic a l Research for Johnson and Johnson (JlsJ), outlined b r ie fly the medical aspects o f t a lc production and u se s. He reported that J& J has been in the ta lc business for over 70 years. T a lc, along with a whole host o f other m aterials can give rise to a b io lo g ic a l response. J& J has not noted any adverse e ffe c t s from the use o f t a lc in e ith er th e ir employees or reported in the lite r a tu r e . T rie manufactured by J& J is h ig h ly refined to produce a " p ie ty t a l c ." A vailab le data in d icates that there is no health hazard associated with the use o f cosmetic grade t a l c . I t war a lso pointed out*that t a lc introduced s u r g ic a lly does not appar en tly cause mesotheliomas. c . B r. Gross o f the Medical U niversity o f South Carolina reported th at there is very l i t t l e i f any data on the e ffe c ts o f t a lc in Plan or animal. In tratrach eal in je c tio n o f ta lc in hamsters caused no i l l e f f e c t s . In these animals no lung scarrin g was scon. Asbestos p a r tic le s less than 5 microns in length reportedly do not cause lung damage. This poin t, however, has not b een d e fin ite ly confirmed. 4 . Dr. E r s y b ill o f FDA' s Bureau o f Foods reported that the sub ject o f asbestos in food and the environment had been evaluated w ithin the past few years and that no need for regulatory action was in dicated . Recent events, however, may require th at the problem be restudled. Dr, Barzil& i o f the Bureau o f Drugs reported that p a rticu la te matter in drug products af@ under study and that he would be very interested in learning about the a n a ly tic a l methodology which can be used for the id en tificatio n of small p a rticle s. 5. Morris Kaplan o f Consumers Union indicated that we always seem to be looking at problems a fte r they occur rather than a n ticip a tin g them. He hoped that e x is tin g knowledge on th subject o f asbestos and t a lc would be resolved in the in te r e st of the consumer rather than in the in te re st o f the producer. Page 5 6. Dr. E str in o f the Cosmetics, T o ile tr y and Fragrance A sso cia tio n reported that the A ssociation was ready to jo in with FDA and the academic community to determine i f there is a consumer sa fe ty problem with t a l c . ANALYTICAL METHODOLOGY The afternoon session was devoted to a discussion o f a n a ly tic a l methods that could be used for the id e n tific a tio n and determination o f asbestos in t a l c . S is presentations were given o u tlin in g methods used in various la b o ra to rie s. 1. Mr. Eisenberg o f the D iv isio n o f Microbiology reported on o p tica l methods, such as the use o f the p o la rizin g microscope, for the detection of asbestoform minerals in t a lc . 2. Dr. Sp ell of Johns Manville Research Center reported that tremolit and ch rysotile could be determined in ta lc at a le v e l o f about 0.5% by x -ra y d iffr a c t io n . Dr. S p e il f e l t , however, that the important question to be answered i s : Eov much 'gets in to the lung o f the person who is exposed? He suggested th at a model be e e t up to determine the real exposure v a lu e s . 3. Dr. Lewin, a consultant for W hittaker, Clark and Daniels reported that x -ra y powder d iffr a c t io n would be an id eal screening techniqui for rapidly determining which samples o f t a lc contain asbestos m inerals. He indicated that there are ta lc s on the market which appear to be ob jectio n ab le. 4. Dr. Danger and Dr. Maggiore o f Mount' Sin ai reported that they use the follow ing techniques to detect and determine asbestoform miner & ls; lig h t microscopy, x -ra y powder d iffr a c t io n , electron microsco electron microprobe and electron d iffr a c t io n . During the d iscu ssi that followed Dr. hanger's presentation he was asked i f he had analyzed a sample, referred to as 344-L, from Johnson and Johnson. He said that he had and that i t was a high q u a lity t a l c . He added that a l l the ta lc producers represented at the meeting pro duced a high q u a lity t a lc product. 5. Dr. Norwood of Charles P fiz e r and Company agreed that x -ra y d lffr a t i e s would be the method o f choice for the analysis o f asbestos ir t a l c . He indicated that by using step scanning and other sophist! techniques you could probably detect down to 0 . 17 o f ch ry so tile ir ta lc . 6 . Dr. Hashed o f Johnson and Johnson introduced Dr. R olle who made a v aila b le a table which outlined " Methods o f Analysis o f Fibers in Talc.*' (Copy attached). Dr. R olle recommended that o p tica l microscopy be used as a f i r s t step in detecting fib ers in t a l c . I f very few or no fib ers ore seen, electron microscopy with e le c t: d iffr a c tio n should be used. I f many fibers are se e n x -ra y d iffr a c t should be used. Page b 7. In clo sin g the meeting Dr. W eissler thanked the p a rticip a n ts and summarised the most promising approaches which might be used to determine the presence o f asbestos in t a l c . Detailed procedures on a n a ly tic a l methodology.will be sent to FDA by some o f the p a rticip an ts at the meeting, end these w ill be synthesized by FDA and circu la te d for comments. \John A . Wenninger A ssista n t C h ie f, Cosmetics Branch D ivision of Colors & Cosmetics Technology The follow ing people attended the symposium: Lewie J . C r a ile y, Ph.D. National In stitu te of Occupational S a fe ty and H ealth, C in cin n a ti, Ohi Irv in g J . S e lik o ff, M.D. Arthur M. Langer, Ph.D. William J . Nicholson, Ph.D. C. J . Haggiore, Ph.D. Mt. Sin ai School of Medicine it it h Malcolm Rees, Ph.D. U. S . Geological Survey Wilsoa Hashed, Ph.D. Gavin K ildick-Sin ith , M.D. R. P. R o lls, Ph.D. T. H. S h e lle y , Ph.D. A. Goudie, Ph.D. Prof. F. B. Pooley (Consultant) W. . Caneer (Consultant Ian M. Stewart, Ph.D. (Consultant) G. R. Grieger, Ph.D. (Consultant) Johnson & Johnson h h It II It II If It Dr. Norwood Harold B. Stanley, J r . , Ph.D. Charles P fiz e r & Company it Commr. Harold Roraer , N .Y .C . Dept, o f A ir Resources S . R. Mounts1er, J r . P rof. S .Z . Lewin (Consultant) Whittaker, Clark A Daniels tt Paul Gross, M.D. Medical U n iv ersity of South Carol Sidney S p e ll, Ph.D. Joh ns-M an vilie Morris Kaplan Consumers Union Homan E s tr in , Ph.D. Murray Berdick, Ph.D. Cosmetic, T o ile try A Fragrance A6 " Herman F . K r a y b ill, Ph.D. Robert M. Schaffner, Ph.D. Alfred W eissler, Ph.D. John M. Gewdy, M-D. Sylvan H. Hewburger, Ph.D. John A. Wenninger Charles J . Kokoski, Ph.D. George Thompson, Ph.D. Dennis J . McGrath, M.B. J . W. Cook Hyman R. G itte s W illiam V. B a r a ila l, M.B. J'tile K. Lamar, M.D. Mrs. Manjeet Singh Armand R. Casola, Ph.D. M. A. Weinberger, M.B. Paul E. CoraeliuBsem K. S . Heine Albert C . Kolbye, M.D. Page 7 Food and Drug A dn dnifitration tl n h It It 91 01 If II It t! II tl ft tl If (b) (5) 4ETH0D :ic a l . :r o s c o p y in n in g c tr o n :r o s c o p y c tr o n ;r o s c o p y tay [fractio n FIBER ANALYSIS QUAL. QUANT. Yes Presence and ' Kind o f Fib er Yes P oin t and Area Count MINIMUM PAR TICLE S IZ E DETECTABLE 0 .5 / ^ LOWER L IM IT OF DETECTABILITY Not A p p licab le Presence of Fib er Yes P oin t and Area Count ^0 Not A p p licab le Yes Presence and Kind o f Fib er Yes P oin t and Area Count ^ 0 . CKL/^ Not A p p licab le Kind o f Fib er Yes (w t/w t) Minimum P a r t i c l e Size for D iffra ctio n r * 0.5% w i s c a . O.lycA- More F a v o ra b le Cases From; R. F . R o ile , Ph.D. Johnson and Johnson Research D ivision New Brunswick, N .J , 08903 TIME FOR QUANTITATr A N A L Y SIS 1/2 Day One Day One Day Two H o u rs t o a Day D epending on Methoc DIVISION OF COLONS AND COSMETICS TECHNOLOGY FOOD AND DRUG ADMINISTRATION. WASHINGTON, D .C. ASBESTOS AND TALC Discussion Session, August 3, 1971, Room 1409, 200 C Street^ S.W, Moderator: Dr. A lfre d W eissler Discussion Topics 1. Asbestos and Talc Mineral Deposits - Dr. Malcolm Ross U .S. Geological Survey 2. Fibrous Content o f Cosmetic Talcum Products - Dr. L. J . C r a lle y NIOSH 3. B io lo gica l-M e d ical S ig n ifica n ce o f Asbestos and Other Fibers * Dr. I . J . S e li k o f f , Mt. S in a i School o f Medi< Dr. G. Kildick'-Sroith, Johnson & Johnson Dr. Paul Gross, Medical U niversity o f S .C . 4 . Current FDA In te re sts in Asbestos - Dr. R. E. B a r z ila i, Bureau o f Drugs Dr. J . K. Lamar, Bureau o f Drugs Dr. H. F. K r a y b ill, Bureau o f Foods 5. Consumer In te re st in Asbestos - Morris Kaplan Consumers Union 6 . Cosmetics Industry In te re st in Asbestos - Dr. Norman E s tr in * CTFA 7. A n a ly tic a l Methods for Asbestos - William Eisenberg, FDA Dr. S. S p e il, Johns M anville S. R liountsier, J r . , W hittaker, Clark & Dr. A. M. Langer, Mt. S in a i Dr. Norwood, Chas. P fiz e r & Company Dr. W. Hashed et a l . , Johnson & Johnson