Document wDqp5ZDm7j29GNOXKBMXX63Qo

FILE NAME: CTFA (CTFA) DATE: 1976 Mar 18 DOC#: CTFA012 DOCUMENT DESCRIPTION: Memo-Asbestos in Talc memorandum TO Robert M. Schaffner, ?h.D. Associate Director for Technology date M arch 18> 1976 FROM Director, Division of Cosmetics Technology (HFP-440) T reviewed the correspondence submitted by CTFA's Dr. Estrin at the meeting of th CTFA Tajc Subcommittee with the FDA on March .15 and would like to submit the following consents : AVON had MoCrorta Associates, a consulting laboratory, evaluate in 1973, 170 talc samples by x-ray diffraction (X-RD). Since 1974, 250 samples have been evaluated in-house by differential thermal analysis (DTA) and by infrared spectroscopy (IR) for treiDollte. This amount: of analytical work appears to confirm Avon's statement that essentially every shipment of talc is ----- tested---ludn-noL .know .Whether. I.lLAs aAfeq.ua,t, to determine tremolite. CRESEBROUGH-POKDS conducted 84 analyses in the last three years for chrysotile and amphiboles by X-RB. Vkere X-RB showed positive results the samples were subjected to analysis by optical micro scopy (0M) to verify the fibrous structure. Chesebrough-Ponds appears to be conducting only random analyses considering their talc business, number of tests conducted a.:d the fact that talcs from three different sources are concurtendy being used. COLGATE-PALMOLTVE 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 raw material and then as a finished product. Tests hove been conducted by Me Crone Associates and in-house using X-RD and 0M or 7EM where necessary to determine the fibrous structure. Three samples, two in 1971 a.d one in 1972, were found to con rain chrysutile up to 100 ppm which Cel gatc-Palmoli ve claims to be possible background contamination Considering the size of Colgate-Palmolive1s talc business,?}: analytical effort is very small. C0TY claims to have analysed selected lets of talc by X-RD and t|4 I Associate Director tor Technology 2 X-RD method up to August 1975 and 5G additional evaluations thereafter. This appears to be aresponsible rest program FABERGE had McCrone Associates investigate 12 talc products in 1972 when the asbestos Issue was first: race A mid an additional si>: samples in November 1975, Obviously, no meaningful quality control program has been instituted. JOHNSON & JOHNSON reports t*.o have tested In* 1972 - 1973, 93 lots of talc by X-RD and since October 1973 an additional 100 lots by X-RD and DTA, end occasionally, where appropriate, by TEM. Allegedly every talc shipment is routinely examined for asbestos. Tho number of analyses appears to be lev?, however. Johnson & Johnson also reported the a-ouly^ts of American and 3ritlsh talc products bussed on a cooperative study between Dr. Danger and Dr. Pooley. This study involved the 19 samples analyzed by Dr, Danger of which 10 samples were implicated to contain asbestos. Wherever Dr. Langer reported tremolile and athophylllte, Dr. Pooley only found anrhophyllite. Dr. Pooley did not find asbestos in those samples where Dr. Langer determined asbestos at concentrations of less than 5% i.e., Dr. Pooley implicated only five samples. In ..... teh-3rirJush.,JuU^ -sasipXes..Jl-- Enc.ey...foAii3id-^lr.hophyLLiLe^ia,.one--and._ Dr. Tinger found anthophyllite and tremoliti in four samples. These were also samples collected in 1973. McCRONE ASSOCIATES reported to have done analytical work under contract for Avon, Bristol-Myers, Chesebrough-Ponds, ColgatePalmolive, Faberge, Johnson & Johnson, Windsor Minerals, and Whittaker, Clark A Daniels, using principally X-RD and OM where appropriate. TEM examinations were also conducted. Since 1973 no ebrysotile or asbesti form amphiboly, was detected, however, no figures were provided on the analyses conducted. STERLING DRUGS the manufacturer of ZBT Baby Powder, reports one-third of all talc lots purchased have been vested by X-RD. No mention is made as to bow many samples of each lot were collected to obtain statisti rally inearp'ng'ul data. Furthermore, it is difficult to determine whether sairpllng of one-third of **:he l;ts Is adequate, particularly if one does not know vhetVtfr cifffei^nt sources of supply were used simultaneously. Associate Director for Technology 3 WHITTAKER, CLARK & DANIELS (WCtD), perhaps the most important supplier ox talcs of various origins and quality grades to the cosmetic industry* claims to have analysed, under contract, 74 samples during the past four years. Considering the nature of VC&D's business volume, the variety of sources of supply, the various qualify grades of talc involved, and the fact that this firm also supplies other ir.iasr-ies with industrial talcs which do contain asbestos, 1 greatly concerned about their limited effort no control the quality of their cosmetic calc. Their sales catalogue lists at least ?0 grades or types of cosmetic talc. Accordingly, any r tn!c underwent one . analysis for anher.ton per year. On the baa in of this effort WC&D 'nave provided their consumers with written assurance that they routinely monitor shipments of ale for asbestiforn minerals and have found no detectable amounts * This assurance might be mis leading and give the cosmetic industry the false impression that WC&D tales 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. T S ^ s x S g B R g r y T " ' 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 asbesto.s 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-RD and DTA procedures and basing the levels of adulteration of talc with asbestos fibers on the levels of sensitivity provided b> these methods. Hain2 J. Eieraaan