Document RNwg15258wxd106j6QEpknoB

FILE NAME: CTFA (CTFA) DATE: 1975 Feb 24 DOC#: CTFA006 DOCUMENT DESCRIPTION: Letter-From Dept of Health, Education & Welfare FILE NAME: CTFA (CTFA) DATE: 1975 Feb 24 DOC#: CTFA006 DOCUMENT DESCRIPTION: Letter - From Dept of Health, Education & W elfare DEPARTMENT OF HEALTH, EDUCATION, AND W ELFARE PUBLIC HEALTH SER VIC E FOOD A N D D R U G A D M IN IS T R A T IO N WASHINGTON. D.C. 20204 February 24, 1975 Mr* Harold Romer C o n s u lta n t to th e Com m issioner 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. Levin'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. Levin'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 diffxactometry 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. Elermann 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: *i 2 (1) Treasonte can be determined reliably at the G.1Z - 0.2* level by step-scanning 2-ray diffraction. Fibrous tresolite, however, cannot be distinguished from Che non-fibrous form. This has to be accomplished by optical microscopy. The determination can be carried out in 3-- 4 hours. The method is unsuitable for the determination of chrysotile because .of chlorite interference. (2) Chrysotile can be determinad by differential thermal analysis (DTA), however, the current detection 1licit is only 12. The analysis can be carried out in ooe hour. (3) Attempts are under vay to Improve the sensitivity of the DTA method to bring the detection level down to Q.5Z, Further improvanent of the detection limit will involve sample enrich-- sent techniques (i.e., specific gravity concentration of asbestos Binarais by means of ultrasonic treatment, centrifugation, or use of heavy liquids). JT * V (4) The Division of Cosmetics Technology (DOST) has analysed by optical microscopy aost of the same talc samples in xhich Dr. S. Z. Levin reported the presence of chrysotile. Chrysotile vas not detected in any of the talc samples. In addition, DCST analysed approximately 60 of Dr. Levin's samples py differential thermal analysis (DTA). DTA indicated the presence of a serpentine sineral in two of these talc samples, (hie of the tvs samples vas exsE-ined by optical microscopy. Chrysotile vas not detected. The remaining sample has not __ yet been examined by cicooscopy. The industry vas urged to participate in the search for improved analytical methodology. The Cosmetic, Toiletry and Fragrance Association talc subcommittee has become actively involved in this product; however, significant progress has cot yet been reported. Liaison is being maintained with this commit tes. If you desire further information concerning the activities c the Bureau of Drugs with regards to asbestos, I suggest you contact Dr. A m a n d S. Casla, Division of Anti-Infective Drug Products, GJD-14Q, Bureau of Drugs, Food and Drug Administratioa, 5600 Fishers Lane, Rockville, Maryland 20852. Sincerely yours, Enclosures i I Sobert M. S ch a ffn a r , Pli.D. Associate Director fer Technology Bureau of Focus !