Document da2debqXNZMgzLDEN5RmqdErR

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION WASHINGTON. D.C. 20204 February 24, 1975 Mr. Harold Romer Consultant to the Commissioner Department of Health Resources 120 Wall Street New York, New York 13005 Dear Mr. Romer: This letter is a follow-up to our telephone conversation of February 13, 1975, regarding the status of FDA's review of talc for asbestos contamination. Enclosed is a copy of Dr. S. Z. Lewin's report of July 10, 1973, regarding his work on the analysis of talc for asbestiform minerals. Dr. S. Z. Lewin of New York University analyzed 195 com mercial cosmetic talc products under FDA contract. Some of the 195 samples were also investigated by Pfizer Inc., Columbia Scientific Industries, and by the Division of Microbiology, Food and Drug Administration. Dr. Lewin's results indicated that 17 of the 195 samples contained up to 15% chrysotile. Many of the chrysotile containing samples were also reported to contain up to 12% tremolite. Tremolite alone was detected in 23 of the samples. The chrysotile content reported by Dr. Lewin could not be con firmed with certainty by other investigators; however, tremolite was detected by others in most instances. The discrepancies in the analytical results, particularly in regard to the chrysotile content, were thought to have been caused by the interference of chlorite, a talc mineral, in the determination of chrysotile by X-ray diffractometry and by the marginal sensitivity of the analytical methods in general. A summary of the results of other investigators who have analyzed the samples which Dr. Lewin found contained either chrysotile or tremolite is also enclosed (see H. J. Eiermann Report 10-1-73). Considerable effort is being invested at the present time In the development of improved instrumental methodology. The current status may be summarized as follows: 2 (1) Tremollte can be determined reliably at the 0.1% - 0.21 level by steo--scanning X--ray diffraction. Fibrous tresKilitc, however, cannot be distinguished from the noti--fibrous fora. This has to be accomplished by optical microscopy. The determination, can. be carried out in 3--4 hours. The sethod is unsuitable for the detemi-nation of chrysotile because of chlorite interference. (2) Chrysotile can be determined by differential thermal analysis (B TA ), however, the current detection limit is only 1%. The analysis can he carried out in one hour. (3) Attempts are under way to improve the sensitivity of the OTA method to bring the detection level down to 0.5%. Further iEsorovaoeat of the detection limit will involve sample enrich ment techniques (i.e., specific gravity concentration of asbestos minerals by means of ultrasonic treatment, centrifugation, or ass of heavy liquids). (4) The Division of Cosmetics Technology (DCST) has analysed by optical microscopy moat of the same talc samples l which Br. S. X. Leifin reported the presence of chrysotile. Chrysotile was sot detected in any of the talc samples. Iu addition, DC5T analysed approximately SO of Dr. Levin'* samples $7 differential thermal analysis (BTA). BTA indicated the presence of a. serpentine mineral in two of these talc samples. On# of the two samples was examined by optical microscopy. Chrysotile was not detected. The remaining sample has act __ yet been examined by microscopy. The industry was urged to participate in the search for improved analytical methodology. The Cosmetic, Toiletry and Fragrance ^ ^ Association talc subcotsmittee has became actively involved in this product; however, significant progress has cot yet been reported. Liaison is being maintained with this committee. If you desire further information concerning the activities of the Bureau of Brags with regards te asbestos, 1 suggest you contact Dr. Anaim-l R."casola, Division of Anti-Infective Brag Products, EFB-14D, Bureau of Drug, Food and Drug Adsiaistratioa, 3600 Fishers Lane, Xackwille, Scryland 2QS52. .Sincerely yours, gohert H. Schsfiner, Ph.B. Associate Director for Technology Bureau of Foods