Document rgO3MYxaKmj9Xdx74RYwdrVq

FILE NAME: CTFA (CTFA) DATE: 1976 Mar 18 DOC#: CTFA012 DOCUMENT DESCRIPTION: Memo - Asbestos in Talc STI MEMORANDUM TO Robert ft. Schaffner, ?h.D. DaTE March 18, 1976 Associate Director for Technology 0$FF-4GC' FROM Director, Division of Cosmetics Technology (KFP-440) T reviewed the correspondence submitted by CTFa 's Dr. Estrin at. the meeting of th CTFA Talc Subcommittee with the FDA on March 15 and would like to submit the following consents: AVON had McCrone Associates, a consulting laboratory, evaluate in 1973, 170 talc samples by x-ray diffraction (X-RD). Since 1974, 250 samples have bean evaluated in-house by differential thermal analysis (DTA) and by infrared spectroscopy (R) for tremolite. Tills amount of analytical, work appears to confirm Avon's statement that essentially every shipment of talc is ----- tested--- I-.dfl.nnt..know whether I K , i s adequate to determine tremolite. CHESEBROUGH -POMPS conducted 84 analyses in the last three years for chrysotile and amphiboles by X-RD. Vhere X-RP showed positive results the samples were subjected no analysis by optical micro scopy (OM) to verify the fibrous structure. Chesebrough-Ponds appears to be conducting only random analyses considering their talc business, number of tests conducted a.:J the fact that talcs from three different sources are concurrently being used. COLGATE-PALMOLIVE claims to have conducted 42 title 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 ss a finished product. Tests have been conducted by McCrone Associates and in-house using X-RD and OM or ?EM where necessary to determine the fibrous structure. Three samples, two in 1971 and one in 1972, were found to contain chrysotile up to 100 pure which Colgate-Palmolive claims to be possible background contamination. Considering the size of Colgate-Palmolive's talc business, the analytical, effort is very small. COTV claims to have analyzed selected lets of talc by X-RD and TF.M at Pfizer's Laboratory. Mo numbers of analyses are provided. The talc supplier is Whittaker, Clark * Darj.fls. CkPRESS INDUSTRIAL MINERALS. C O., a supplie, of Montana Talc to the elate Director for Technology 2 X-RD method up to August 1975 and 5G aedi clonal evaluat ions thereafter. This appears to be a responsible rest program. FABERGE had McCrone Associates investigate 12 itale, products in 1972 when the asbestos issue was first: rained end an additional six samples in November 1975. Obviously, no meaningful quality control program has been instituted. JOHNSON & JOHNSON reports to 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, and occasionally, where appropriate, by TEM. Allegedly every talc shipment is routinely examined for asbestos. The number of analyses appears to be. low, however. Johnson & Johnson also reported the 5.;..lysis or" American and 3ritish talc products bused on a cooperative study between Dr. Danger and Dr. Pooley. This study involved the 19 samples? analyzed by Dr. Danger of which 10 samples ware implicated to contain asbestos. Wherever Dr. Danger reported tremoli re and sothophyllite, Dr. Pooley only found anthophyllite. Dr. Pcclcy did not find asbestos in those samples where Dr. hanger determined asbestos at concentrations of less than 5% i.a., Dr. Pooley implicated only five samples. In .tha-3i;iJnlsli...4ralx..-saffip.les..-Dr-- .Boaley....tond-- an.thophyliia..in.one...and.___ Dr. T,anger found anthophyllite and Cremolite in four samples. These were also samples coll acted in 1973. McCRONE ASSOCIATES reported to have done analytical work under contract for Avon, Bristol-Myers, Chesebrough-Pcnds, ColgatePalmolive, Faberge, Johnson & Johnson, Windsor Minerals, and Whittaker, Clark & Daniels, using principally X-RD and OM where appropriate. TEM examinationswere also conducted. Since 1973 no ebrysotile or asbesti form araphthole .. was detected, however, no figures were provided on the analyses conducted. STERLING DRUGS, the manufacturer of ZBT Baby Powder, reports one-third of all ta.i.c iots purchased have been tested by X-RD. No mention is made as to bow many samples of each lot ware collected to obtain sr.atiKtJr.ally me an' n v;' u 1 data. FurtLtnm?re, it is difficult to determine whether sampling of one-third of he lots is adequate, particularly if one roes not know w harf~'X diii'ai ant sources of supply were used simultaneously. Associate Director for Technology 3 VH ITTAKER, C LARK. h DANIELS (WCAD); perhaps the most important supplier of 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 WCSD's business volume, the variety of 30 utc.es of supply, the various quality grades of talc involved, and the fact that this firm also supplies other ir.dusfvies 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 30 grades or types of cosmetic talc. Accordingly, any type or talc underwent one analysis for asbestos per year. On the basis of this effort VC&D have provided their consumers with written assurance that they routinely monitor shipments of !sjc for asbestifonn 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 ant also very much concerned about the ract that a firm of this standing in the cosmetic industry does not have facilities to do its own analytical work. Tn~sumffigr9".' Though--ther-^nbini-esi-on--%v--Ehe---CTS^Xalc..Jk&aaMaittee 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 V;, these methods. Heinz J. Eiermaan