Document k6YL4b9ZJGd8BeYjyyv7DEvMb

FILE NAME Talc TALC DATE 1976 Mar 18 DOC TALC154 DOCUMENT DESCRIPTION Memos RE Asbestos in Talc MEMORANDUM MEMORANDUM DEPARTMENT OF HEALTH EDUCATION AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION TO TO Robert M. Schaffner Ph.D. DATE March 18 1976 Associate Director for Technology RAF RAF RAF Director Division of Cosmetics Technology HFF Asbestos in Talc I reviewed meeting of would like the the correspondence submitted by CTFA Talc Subcommittee with CTFA's Dr. the FDA on to submit the following comments Estrin at the March 15 and AVON had McCrone Associates a consulting laboratory evaluate in 1973 170 talc samples byray diffraction RD Since 1974 250 samples have been evaluated house by differential thermal analysis DTA and by infrared spectroscopy IR for tremolite This amount of analytical work appears to confirm Avon's tested statement that essentially do not know whether IR every shipment of talc is is adequate todetermine tremolite CHESEBROUGH conducted 84 analyses in the last three years for chrysotile and amphiboles by RD Where RD showed positive results the samples were subjected to analysis by optical microscopy OM to verify the fibrous structure Chesebrough appears to be conducting only random analyses considering their talc business number of tests conducted and the fact that talcs from three different sources are concurrently being used 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 raw material and then as a finished product Tests have been conducted by McCrone Associates and house using 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 ppm which Palmolive claims to be possible background contamination Considering the size of Palmolive's talc business the analytical effort is very small COTY claims to have analyzed selected lots TEMat Pfizer's Laboratory No numbers of of talc by RD and analyses are provided The talc supplier is Whittaker Clark & Daniels CYPRESS INDUSTRIAL MINERALS CO a supplier of Montana Talc to the cosmetic industry claims to have conducted 2,839 evaluations by CTFA's CTFA's Associate Director for Technology 2 RD method thereafter up to This August 1975 and appears to be a 50 additional evaluations responsible test program FABERGE had McCrone Associates investigate 12 1972 when the asbestos issue was first raised talc products in and an additional six samples in November 1975. Obviously control program has been instituted no meaningful quality JOHNSON & JOHNSON reports to have tested in 1972 F 1973 93 lots of talc by RD and since October 1973 an additional 100 lots by 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 analyses of talc products based on a cooperative cooperative samples Dr. Pooley This study involved the the American and British study between Dr. Langer and 19 samples analyzed by Dr. Langer of which 10 samples were implicated implicated to contain asbestos Wherever Dr. Langer reported tremolite and anthophyllite Dr. Pooley only found anthophyllite Dr. Pooley did not find asbestos in those samples where Dr. Langer determined asbestos at concentrations of less than % i.e. Dr. Pooley implicated only five samples In the British talc samples Dr. Pooley found anthophyllite in one and Dr. Langer found anthophyllite and tremolite in four samples These were also samples collected in 1973 MCCRONE ASSOCIATES reported to have done analytical work under Bristol contract for Avon Chesebrough Colgate- Palmolive Faberge Johnson & Johnson Windsor Minerals and Whittaker Clark & Daniels using principally RD and OM where appropriate TEM examinations also conducted Since 1973 no chrysotile or asbestiform amphibole was detected however no figures were provided on the analyses conducted STERLING DRUGS the manufacturer of ZBT Baby Powder reports third of all talc lots purchased have been tested by RD No mention is made as to how many samples of each lot were collected to obtain statistically meaningful data Furthermore it is difficult to determine whether sampling of third of the lots is adequate particularly if one does not know whether different sources of supply were used simultaneously Associate Director for Technology 3 WHITTAKER CLARK & supplier of talcs DANIELS WC perhaps of various origins and the most important quality grades to the cosmetic industry claims to have analyzed under contract 74 samples during the past four years Considering the nature of 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 I am greatly concerned about limited effort to control the quality of their cosmetic their talc Their sales catalogue lists at least 20 grades or types of cosmetic talc Accordingly any type of talc underwent one analysis for asbestos per year On the basis of this effort WC have provided their consumers with written assurance that they routinely monitor shipments of talc 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 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 In summary though submission Talc Subcommittee 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 tale 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 RD and DTA procedures and basing the levels of adulteration of talc with asbestos fibers on the levels of sensitivity provided by these methods Asesora Asesora Asesora Asesora Asesora Asesora Asesora Asesora ' Asesora Asesora AsesorAseasora Heinz J. Fiermann MEMORANDUM Acting Director Bureau of Foods EDUCATION DEPARTMENT OF HEALTH PUBLIC HEALTH EDUCATION AND WELFARE SERVICE w a FOOD AND DRUG ADMINISTRATION __ DATE March 19 1976 Associate Director for Technology SUBJECT Asbestos in Talc - Proposed Regulation As you may recall since the recent Washington Post article our people have been having numerous meetings with members of the cosmetic industry regarding talc At our last meeting on March 15 1976 various companies submitted to Mr. Eiermann summaries of their analyses Mr. Mr. Mr. Eiermann has in summaries and comes the attached memorandum evaluated their to the conclusion that although the com- panies have done some work the work has not been terribly extensive and based on the work to date we probably could tarle tarle ae x ty JONNY not say with the problem certainty that the industry is recommaednedqsuately Therefore Mr. Eiermann and handling concur esesens tials ly entially y n ny em \ Yr \\ 7 \ that a proposed that talc would diffraction and regulation be drawunp stating essentially be asbestos free when examined by using ray differential thermal analysis ever tate If you agree we will prepare such a proposed regulation discuss with our counterparts within the Agency and try to Complian have it to you within a month If you agree to the proposal Complian Complian think it should appear on our priority list and I would sug- Complian gest that we plan to have the second quarter of the it ready to leave the 1976 calendar year Bureau during , a a ()tp of a Pog f \! teetact Schaf ner NAoF Robert M. Schaffner Attachment cc HFF