Document 99mObDyVD8kokOr91k4508Oyq

FILE NAME Talc TALC DATE 1971 Aug 3 DOC TALC420 DOCUMENT DESCRIPTION Agenda & Summary of FDA Meeting RE Asbestos & Talc on DIVISION OF COLORS AND COSMETICS TECHNOLOGY FOOD DRUG ADMINISTRATION 7 re WASHINGTON D.C. : ASBESTOASSBESTOSANDVALG 3 7 Discussion Scasion August 3 1971 Room 1409 200 C Street .. , Moderator Dr. Alfred Weissler Masussion Topica Deposits 2. Asbestos and Tale Mineral Mineral ~ - Dr. Malcolm Rosa . to Te ... By Fibrous Content of - Cosmetic Talem Products Dr. L. J. Cralley a , | 11108H Solikoff 3. BiologicalSignificanceSignificance of Aberton Other Fiber Sinai , of Medicine Medicine SG . J. SolikoffSolikoff Mt. School Dr. C. dick Sith Sith Johnson&Johnson Dr. Halal Halal Halal Halal Halal Unity Unity Unity eb 8 InteFrDAeIsntetressts Bureau ofDrugs| Consumer Interest in Asbeso toe n NorrinKaplan ; . a Consumers Union Bey -Dr. NormanNorman EstrinEstrin a = . Dr. SMo.unEtissieenbrerg 8 eT Mountsier 12 he Mer 15 15 i face Se Sra ARETE SEC EE NER use emt eenLOI etegt eee a HEMORANDUM OVAS71PO004S71PO004 August 3 1971 ASBESTOS ASBESTOS ASBESTOS A 7210 72le1 na 72100 7210 7210 + sb Hold at the Food and Drug Adinisgration Adinisgration Adinisgration | 200 C Surse . Machfgton Machfgton DC 20384 re Colors Technolgy her Medaretor Dr. Alfred Wincler Director Director Division of & Cortion Cortion Cortion Technolgy SUMMARY SUMMARY SUMMARY SUMMARY The amount of noboston fibers in ralcum powderproductapowderproducta Pea the busiang a. health hazards capociated with their prononce are subjects of current Interest but differing differing reported reportedreported 8 At a nymphatua nymphatua nymphatua bed on Apt 3 3 tho To il Gtaledacedreten hectic by over 40 fentines fentines platebd ad copie copie , Ph " a & lly p ww p major Lelutively that song inleum perdors of major nabestral nabestral unig unig unig unig Lelutively ; : . . fideos Nevertheless on behalf of consumere consumere working Inhoratory Inhoratory procedure procedure for the nash dn contengful en will give contengful contengful 10 FDA oflent oflent oflent oflent oflent , on the oflentoflent details a poodera poodera Witt analyods the amount Accurate for of cabenton in talcum powder will be binable accordintgo anyof the participent participent by th tie me ne a battery of specialised instruct and techniques includingincluding ray diffree . tion polazizin ' polazizin opeical mexcopy a Loe Ee a of Acented Acented pri o election copy and clectrocnlectron clectron eo ee - discussions In addition to extensive analytical nodical uned by Verica ihetuudesShe nodical afgificance afgificance afgificanocfe ezenket ezenket optoes of auben concept conceptconcept conceptconcept for acbentos ', Tr of the bee hie methods these much optoes optoesoptoes and oth oo vei didhenyt, Oe : cid rks we tien ae INTRODUCTIONINTRODUCTION cutlining Dr. Welanlar opened the meetingby cutlining comoof the events which had brought . question of asheaton asheaton perticles tale to the attention of FDA from He indicated that in responsteo a letter Jerona Kretchmer Administrator Divinental Divinental Divinental Protection Agency New YorkCity to HEL Secretary Richardson on Jura 28 1971 cho tos Jura Sn TEA +. vetak ing top p s to investigate investigateinvestigate the problem oa r aboe ae ee 000143 a fine sten the FDA tould like to establish a Li boy codure for the deteretantion of cheston in tilema ponder dezinho dezinho viil ' innigfainnilgfal and constatout reculto upon FDV would in a portion portion portion to chen.roberts determine chen.roberts bar . Once the ethodology in agreed market if such products on the oo : ee Ne forms of the rooting constated of abort pugnertationbsy each partici jent fabi y far ir fair which " to pool there there at No gapeete P A Mat of the ferventos toples fas attached toa , GW KRAL DISCUSSION a. Dr. Mose of the U.S. Nological Nological Survey made the fiat presentpraesentatiotn prieseontatnion narologist bes Bear oclined wineteh narologist poch. poch Twith Twith which ensued ensued the following licnt the vovhouy cities of cobearbe the presentatiopresenntation andand the S dllocution dllocution dllocution . polute charged te MafinitionMafinition Asbestos As a generico generico for a variety of hydrated silicate r^"neralwhich have one come attribute Aung y beerpasivay beerpasivay beerpasivay beerpasivay beerpasivay not ett be Although the roads only ociated with those variotion pertince which have techologic implicabl implicabl implicabimpllicabl fe ald, wartedo ich (26 the above dens. pi pi pi pi pi ona minazalminazal is perhaps most descriptive ( . Py a Taare, cent ne lig of about fas free can be divided into men cleases on the brain of theixtheix crystal eenturees entures _ expeutit expeutit expeutit nd bical The cole ber of that that feet clans asbestos " in chrysotilechrysotile chrysotile the best.foza best.foza Mio. Mio. Mio. Mio. which is by far the most common of It accountaccountaccount fee fee then then then 82 of of th ambenton fiber produced today AlthoughAlthough theemphiboles are coroncoron r abundant formforiming ngmineralsminerals th : racetoform racetoform varieties are much much lepo abundant thenthenchrysotile 1ee c The empiriceal mpirical fomulaofthethe end Reaa Pobse vokowes cao be represented as follows follows re Doge Ley ra Shy vig WING Serpentine Cloon Chrynotile83 612 05 011 000144 Apphibola Claun Claun Claun Anthophy11 Anthophy11 11g Ye 18.9118.91 18.91 18.9118.91 ( ( 8 ) 2 Tromolice Tromolice Cay Mas St 22 0aoa s ) 2 Actinolite Cng NE Fe Sg 18922 102 gelatively diljenki d da ut ual to fluf lange variations variations Rs Co ate on of a minorel within gelatively all and Avan diljenki The devices devices depend to genting genting on the mineralogy mineralogy " involvod . ake ot 7m 7 Health spoke on the fibrous content of cosmetic talcum products Ho presentation conuereidn part a on paper be coated coated coated entitled entitled ne ME Fibrouvelos gion oral Content of Cometic Talcum Products Amer Jlie conclusions were made in this paper 350-4 1968 the following With the exception of 4 of the 22 cosmetic thieur deodnele and the lovele of feali feali 2416 nickel chro.fuanmd mangva eranpe enasrae ll of a low magniantd uwid the in a narrow rung~ It in not mv whether the lone producta letras galf- galf- Scant proportion of onies in theindustry or to what extent the sources of the tale in three lations are the out out ourced ourced male fox we in other talem products in the four form opal find competitive market The levels of silica chorium chorium and nickel in these four products are sufficiently high however to be of con in the potential to add in . | All of the calcum product analged betalen betalen appe ok + oy or a 20 of of the total cum particulareansd orging 19 - 2 The fibrous storial was predominanttellye but pro- 7 bably contained minor counts of xenolico authophys 11t ande chrysotile en chiacrecoo ften present in OARS rents SE cludedPAL Leonie Geen Leind peeed ' Fi 2 chouid in cluded ca ae 4 aif fiber from , which defheednefdend defend fo o as BA eas a MOE . ORV is FEthe lungosf tran the preta he c pree ace of ( these ferruginous bodies however certain 5 : 5 e third discussion topiocn the program dealt with the biologicaanld - medical cignificance of cobeatos and other fibers Three openkoro addrens^' themselves to this topic 90cobeatos 8 Ue Ee mee ne hes Me, Tapa 4 e a alpulation ' problem peenestad to the prs alpulation alpulation achenton It was considered considered at that met athad athad to met be inly n koncocwluepdagte iknowoledgenahlas pgrroebaltelmy inHce reraespeodrtheids tchoatncerrencenotvleyr tachqeuirwedhaocquirled e question of asbestos fibero in the environment No felt the the now diction added to the problem wawsas the pagal- bility that lung cancer may could sheva sheva ercupation level 1000 then expozuzen expozuzen et SmithJJ aspects biological b Dr. Hildick Hildick Smith Director of ChinchChinch Chinch For Johnca | and Jolimon JJ outlined briefly the medical of tale production and uses He He reported that J has been in the tale bantuan for over 70 years Pla along with wh wh host of other materialo can give rise to a rresponge esponge J67 hen not notednoted my / dvosed dvosed effect effectfrom the use of tale in alther the employees employees by reported reported in Lis : icontuto manufactured manufactured Tale manufactured . by 363 is highly refined to produce a platy tale Adable data indicates that there is no health associated hazard with the use of cosmetic grade Cole IC WO nino petuted petuted cutting cutting cate introdointrodo introdo congeally does not ently chicq monotholforas monotholforas appar Gre c Dr. of the dial University UniversityUniversito y f South Carolina reported little that there in very little if any data on the offects of tale in man or coused neen not animal- Intratracheal injectiofon tale in hamsters no 111 feel oS thingthing cano cano Jug roeerts hamsters Asbeston particles labsthen 5 lezeno in length reportsdiy cauza ung dage ThisThis point however has been definitely coniimmed . a a Dr. Kraybill Bureau 4 of 1DA'e of Foods that *, ey,te, 2 cebenton reported in food and the enviromentenviroment had Counting Counting Counting Counting Counting Counting Counting Counting Counting Counting Counting Counting Counting Counting CountinCgounting Counting Counting Counting Counting Counting . CountingCountine ge Counting ata ts Counting at Recent evento however requing that theproblem be restudied Recent may requing | Barzilat Dr. of ding lytical can Accents Barzilat of products arthe Accents pyc a Bureau Drug reported . that particulate diab diab ew ee lytical methodologyae CMe nt ve Tebow uted gal. methodologymethodology which Accents Accents Accents be uned for the Consters 5. Morric : Morric Kaplan indicated that always Union Tooked Tooked at of indicated prime prime they occur thereparing thereparing subject prime asbestos hoped isting knowledge on the subject subject in would be rented of rather producar the in interest interest of the rented the consumer consumer thereparing thereparing recto va thereparing thereparing thereparing recto bes the| hi^fe fee of asbestos asbestos and tale than the 000146 RSI Gem PAREMT erI tE ieN s ey 4 ee Dri Motrin of the CebustioCnebustion ToiletTry oiletry surt kagamine that the Apociation une ready to with FDA and cho determine to thoru if to a consumer ocfety problem problem with o fonsistion fonsistion fonsistion andand and nendemic nendemic community tule CAPICALLY CAPICALLY CAPICALLYCAPICALLY The afteronin afteronin sesalon was devoted to a dispusates Of ; thew wintesta out could be used for the identificaci^nnad decenation of asinatos in Life Six prosentations were given outlining methods used in valious Leborn man at 14 Ye. Eigenberg of the Division of Microbiology Microbiology reportedreported an epitaal epitaal methode much as the of the polarizing dicip dus the detection of clitoralo clitoralo in tnlc. Dr. Spail of Johns Manville Rodovch Contor that relied reported and chrysoLfic be.date.ined be.date.ined in could 0.5 by xay difction diffction Dr. Spelle calc ce a level of about about about Spelle however that Important question question to be andered io How mich gets into the Thng of the nauson who ts exposed Me used that a al . relied not up to determine the real exposure values Tor Dr. His petulant feeWalported Walported Walported WalportedWalported perfection thet ray perfection perfection would be an ideal screening technique technique technique objectionable determining for rapidly th^>ch sampice of tale contufo dobustes minarele HedenteHdedented Hedented that there are telen on the market ob^>n^"t Appear to be objectionable objectionable Maggiore use Dr. Langer and Dr. of Mount Sinai that they reported use the following technique to detect Py retornine retornine rebent form 1 : mic ale Right picroscopy day praction praction pprraactciotnion praction alacton electron mexsprobe mexsprobe Janger's pres^'ntation wasThankig had that fwot llowed Dr. . and election Janger's fiction fictfiictiononffiiccttiioonn fiction he was the discussion if asked he ce Pog 2 3446 oo he : He said that he had and that it was highhigh quality tale He high quality product added that all the tale producero represented at the meeting pro- duceda tale Dr. HorwHoool rwool of Chain Pend Pend fompn ey ane they they site. ; = other sophisticH techniques step SCANNING tale a rs using using 2 dated you could probably probably dated dated dated to 0.1 on choir choir in TEU fl Nasked of Johnson and Johnson introduced Dr. Rolle who made x. available table which outlined Methods of Analysin of Fiboro in Talc Copy attached Dr. Rolle recommended that optionl- diffraction used microscopy he step step step stepstep decreting fiber in cale If very fo or no fibers are seen electron microscopy with cheerson cheerson diffction diffction chould be used Thy Thy Fiera are ecen ray diffraction diffraction should be used oe 000147 Dr. at 7. In closing the resting Welobter dhisked the participants mid approactus tech night he need to determine determine seen red theoft bancproousinginprouitng aaplpreoactus ctiled procedures on cutlyi feat will be mtehetphroeadmeodlogy caut to FDA by some of the participants the meeting and thene vill bo cynglinized by FDA and circulated for consent Jan Monninger Jan Monninger a Monninger JaJ n an ection John A. radnict Monninger Abafett Gief ection ection Breach Breach Breach Division of Colabatire Colabatire ColabatirColabeatire Teit sg! The following people attended Louis J. Grally .. the symposium symposium ' bokeh criture ' Safety and Health of a Pate pteteed Chichimati Onto Irving J. Selikoff H.D. Arthur H. Boy Ph.D. WI 3 Wenetsoo, Ph.D. - Miand Miand School of Medicine : ". 41 11 linlcolm Roon Thib Wilson Heshed Ph.D. Gavin R. P. I. 13th 13th 13th M.D. Rolle Ph.D. Shelley Ph.D. A. Goudia PhD Crosulurne e. Prof. F. B. Posley Crosulurne W. T. Cancer Consultant In 11. Stout Tha ( la G. R. Grieger Ph.D. Consultant U. s Geological Survey Johnson Johnson . " { " " " te " "i | : : { at Com Harold Romer 3 7 : MY.C. Dept. of Air Resources Prof. S.Z. Levin Consultant Consultant Pak Gran 11.17 oy - Sidney Spell Ph.D. Whitakery Cloric & Diale Medical Univocity of South Carolina Carolina Joline ville ville Morris Yo pn Norman Enerin Ph.D. Thurdy Bordick Ph.D. Consumers Union os gros Cosmetic Toiletry & Fragrance Acnn 000148