Document M9RKmb663Y9mxkj28ydvnV3M

MEMORANDUM D E P a R T M ENT OF HEALTH, EDUCATI ON, A N D WEI.FAK l'JLC H i'.'.LTH .SI.'A ICE 'c.'Orj 'Xi.i DRUG ADMJ.N'IS TKaTION TO FROM Robert >1. Schaffner, Ph.D. Associate Director for Technology Date. (HFF--400)F:NI //A;./1 I Jf'\ March IS, 1976 Director, Division of Cosmetics Technology {HFF--440) SUBJECT Asbestos in Talc 1 reviewed the correspondence submitted by CTFA's Dr. Escrin at the meeting of the CT'FA Talc Subcommittee with the FDA on March 15 and would like to submit the following comments: ' ^ T o - f M^ rone Associates, a consulting laboratory, evaluate o' 1 / 0 talc samPles by x-ray diffraction (X-RD) . Since 19M, 250 samples have been evaluated in-house by differential thermal analysis (DTA) and by infrared spectroscopy (IR) for Lremolite. This amount of analytical work appears to confirm Avon s statement that essentially every shipment of talc is '"1"e'1^ ^ dii_nc!.t 3mQw._h.hftthftr-- IE_iS.adgq.aajLS_t..P.determine trerao1ite. gHaSEBROUGH-PONpS conducted 84 analyses in the last three years for chrysotile and amphiboles by X-RD. Where X-RD shewed positive results the samples were subjected to analysis by optical micro scopy (0M) to verify the fibrous structure. Chesebruugh-Ponds appears to be conducting only random analyses considering tbeir talc business, number of tests conducted and the fact chat talcs from three different sources are concurrently being used. .gQLGATE--PALMOLIVE, claims to have conducted 42 talc analyses since 1971, however, these analyses reflect only 20 raw materials and" 17 finished products, and the same material may have been tested twice, first as a rati material and then as a finished product. Tests have been conducted by McCrone Associates and in-house ' using X-RD and OM or TEM where necessary to determine the fibrous structure. Three samples, two in 1971 and one in 1972, were found to contain chrysotile up to 100 port which Colgate-Palmolive claims to be possible background contamination. Considering the size of Colgate-Palmolive's talc business.the analytical effort is very small. '` CO'TY claims to have analyzed selected lots of talc by X-RD and TEM at. Pfizer's Laboratory. No numbers of analyses are provided. The talc supplier is Whittaker, Clark & Daniels. INDUSTRIAL MINERALS, CO., a supplier of Montana Talc to the cosmetic, industry claims to have conducted 2,839 evaluations by CTFA's PLAINTIFF S EXHIBIT WCD-226 sociat.e Director for Techuolo gy " ? J Augcst 1975 a"d 50 * * , 1 ' ,k" " * to be a responsible test progr.j. FABER6E had McCrone Associates invest!care 12 rale f l r s c ^1972 when the asbestos .Issue vas *- sis samples In Soveaber 1975. Obviously. ;10 nesrvo.fi,, control program has been instituted. q ~ Ly reports to have tested ip*] 97? ,, 1 9 n . X - R f d SinCe ft0ber 1973 ' W o J 'ifc l o t ^ y 4 1 1 ^ ir ' and ^ s i o n a i i y , ,,here appropriate, by m . T h l p diy 7 ry fSlC Shlp:nftnt is routinely examined for asbestos The number of analyses appears to be lew, however. Johnson & Johnson also reported the analvses of ,, j .. Sr?K 3s U K a s w a a s r f f l ^ T S K i J S S Z J ,t in of less than 57 i p p*. v.% "tLCd oSbe:aLOt at concentrations the i n Vi \ Dr` P0ley p l i c a t e d only five samples. In Dr. Danger found anthophyllite and tramolite in'four samples The-e" wei e also samples collected in 1973, ^ M c C p N O | S 0 C | A T E S reported to have done analytical work under contract foi Avon, Bristol-Myers, Chesebrough-Ponds, Colgate- *-ltnol*ve, Faberge, Johnson & Johnson, Windsor Minerals, and .littaker, Clark & Daniels, using principally X-RD and DM where appropriate. TEM examinations were also conducted. Since 1973 no chrysotile or asbestiform amphiboly was detected, however no ngures were provided on the analyses conducted. * I P B M N G ^ R I j p the manufacturer of ZBT Baby Powder, reports one-third Oj all talc .Lots purchased have been tested by X-RD. Nc> mention is m a d e a s to how many samples of each lot were collected to obtain statistically meanmgrul data. Furthermore, it is difficult to determine whether sampling of one-third of the lots i adequate particularly if one does not know whether different sources of ' supply were used simultaneously* ~ .Associate Director for Technology 3 WHITTAKER, CLARK & DANIELS (WC&D), perhaps the most important supplier of talcs of various origins and quality grades to the cosmetic industry, cJ.ai.Tns to have analysed, under contract, I k samples during the pest four years. Considering the nature of WC&D's business volume, the variety of sources of supply, the various quality grades of talc involved, and the fact that this firm also supplies other industries with industrial talcs which do contain asbestos, 1 am greatly concerned about their limited effort to control the quality of their cosmetic talc. Their sales catalogue lists at least 20 grades of types of cosmetic, talc. Accordingly, any type n f talc underwent one analysis for asbestos per year. On the basis ot this effort WC&D have provided their consumers with written assurance that they routinely monitor shipments of tajc for asbestiform minerals and have found no detectable amounts, This assurance might be mis leading and give the cosmetic industry the false impression that WC&D talcs are adequately tested for asbestos. I am also very much concerned about the fact that a firm of this standing in the cosmetic industry does not have facilities to do its own analytical work. TfjF.nwnaTy7--rtrmTgh--riTe--sttfamjasierr-by--che--CTJ^-Xaln^.nhnoi3iidtt.tee looks__ impressive at first hand, it does not offer much assurance that cosmetic talcs are adequately tested for asbestos. If this is all that can be expected from the cosmetic industry in the form of analytical effort in the light of the asbestos in talc publicity since 1971, we have not much choice but to move ahead as speedily as possible with a proposal of a regulation on asbestos in talc using X-'R.D and DTA procedures and basing the levels of adulteration of talc, with asbestos fibers on the levels of sensitivity provided by these methods. /A A ,* Hein?. J. Eiermann