Document 1D5Qzp37OVVE4pOjkbREXn6K

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 & Welfare D EPARTM EN T OF HEALTH. EDUCATION. AND PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION W A SH IN G T O N . D .C . 2020 WELFARE February 24, 1975 Mr. Harold Rmer C o n s u lta n t to th e C om 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. 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. Tremolita 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: i 2 * (1) XresollEe can be determined reliably at the 0.11 - 0.22 level by step-scanning I-ray diffraction. Fibrous tresolite, however, cannot be distinguished froa the non-fibrous fora. 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 determined by differential therasl analysis (DTA), however, the current detection limit is only IT. The analysis can. be carried out in one hour. (3) Attempts are under way to improve the sensitivity of the DTA method to bring the detection level down to 0.52. Further improvement 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 (BCST) has analysed by optical microscopy most of the same talc samples in rhich Dr. S. 2. Lewin reported the presence of chrysotile. Chrysotile was not detected in any of the talc samples. In addition, BCST analyzed approximately 60 of Dr. Lewis's samples $y differential thermal analysis (DTA). DTA indicated the presence of a serpentine mineral is two of these talc earples. Ose of the two samples vaa exstdaed by optical silerosccpy. Chrysotile was not detected. The remaining sample has not __yet been examined by eiccoecopy. The industry ves urged to participate in the search for improved analytical methodology. The Cosmetic, Toiletry and Fragrance Association talc subcommittee has beccxae actively involved is this product; however, significant progress has not yet been reported. Liaison is being maintained with this committee. If you desire further infernstion concerning the activities cf the Bureau of Drugs with regards to asbestos I suggest you contact Dr. Armad . Casla, Division of Anti-Infective Drag Products, EFD-140, Bureau of Drugs, Pood and Drug Administration, 5600 Fishers Lane, Rockville, K&ryland 20852. Sincerely yours, Enclosures t I Robert H. Schsffeer, Ph.3. Associate Director for Technology Bureau of Foods