Document qaNaXdy0LNZVvookrZG6QZ4JR

vfMW cn^'ofiAu an D O M ESTIC O PER A TIN G CO M PAN Y ' ' N E W B R U N S W I C K . N. J. 0 8 9 0 3 December 29, 1975 Hr. George Sandland Chairman, CTFA Committee on Asbestos in Talc Bristol Myers Products 225 Long Avenue Hillside., New Jersey 07207 Dear George, ^- The samples of S. Z. Lewin cosmetic talcum powders you received from Mr. Henry Davis, Division of Cosmetic Technology, Bureau of Foods, Food and Drug Administration have been analyzed for asbestiform amphibole by the CTFA procedure entitled ''Detection"of Asbestiform Amphibole Minerals in Cosmetic Talc" . As you know the CTFA method requires a slow x-ray diffraction scan in the region of 8.85-8.04A (11.0-10.0 29) for a peak indicating the possible presence of an amphibole mineral. If a peak is seen in this region then the talc is acid treated to remove interfering carbonate minerals and then examining by an optical microscopy/dispersion-staining procedure to confirm, the presence of amphibole and to see if it is the asbestiform variety. The criteria for asbestiform amphibole is the one adopted by the U.S. Department of Labor, Occupational Safety and Health Administration, Field Information Memorandum #74-92, November 21, 1974 which requires: a. Particles must appear to be fibrous rather than as crystals or slivers. b. The maximum diameter of a fiber to be counted is 3 microns. c. The maximumlength of afiber to be counted is 30 microns. ` d. The length to widthratio must be 5 or more to 1, that is, 5 times or more longer than wide. e. The separate or individual fibers must contain fibrils or the "bundle of sticks" effect, unless they are at a. non-divisible stage. A fibril cannot be subdivided and would be counted, if it meets the other criteria. The length to width ratio of 5 or more to 1 is not meant to imply that other particles are not hazardous. * S ^ * I-------- * '. - JAN14 1376 . G. W. SANDLAND HHS00000061 Analysis of FDA Samples for Asbestiform Amphibole FDA Code #DCST Amphibole X-ray Diffraction Asbestiform AmphiboT Dispersion Staining/ Optical Microscopy Pass/Fail 1338 1339 1340 Trace Trace Minor 1341 ' Minor '1342 - Trace 1343 Minor 1344 - Minor 1345 Minor 1346 1347 None Detected Trace 1348 Minor 1349 1350 None Detected Minor ' 1351 1352 None Detected None Detected * Amphibole confirmed/ not asbestiform Amphibole confirmed/ not asbestiform Amphibole confirmed/ not asbestiform Amphibole confirmed/ not asbestiform Amphibole confirmed not asbestiform Amphibole confirmed/ not asbestiform -' Amphibole confirmed/ asbestiform Amphibole confirmed/ not asbestiform '- Amphibole confirmed/ not asbestiform -' _ -- . Pass Pass Pass Pass Pass Pass Pass Pass Pass Conditional Faila Pass Pass Pass Pass Pass Quantitative Estimation Trace = 0 - 2 % (w/w) Minor - 2 - 10%. (w/w) *Talc was very fine; its size approached the resolution of the dispersion staining/optical microscopy method (5 urn) so a definitive answer by this method was not possible. A scanning electron microscope was employed for the detection of ''fibers" using the OSHA definition and none were seen. ' aA first examination revealed one bundle of amphibole fibers. This sample when examined twice more by the same operator did not reveal any asbestiform amphibole. HHS00000062 Mr. Davis also requested that serpentine analysis be performed on several samples. Sample DCST 1339 was found to contain approxi mately 1% serpentine by differential thermal analysis (DTA). Samples DCST 1341, 1347 and 1351 had many interfering DTA peaks in the thermogram caused by large quantities of impurities such . as chlorite and as a result the presence or absence of serpentine could not be determined. Sample DCST 1352 has no detectable levels of serpentine. We know of no completely successful routine backup method to DTA, however an optical microscopy examination of all five samples revealed no fibrous serpentine minerals. F. Robert Rolle, Ph.D. Chairman, CTFA Task Force on Methodology for the Detection of Asbestos Talc kd HHS00000063 DCST # 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 1350 1351 1352 Lewin # 72 77 96 97 101 102A 143 144B 151 154 15 7A 160 163 75 173A Product Lady Ester Face Powder, Rachel Touch and Glow Face Powder Blanchard's Dusting Powder Born Wild Dusting Powder, Del Labs ; ; Tai Winds Spray Talc, Avon ;; Tosca Dusting Powder j ; Pin-Zow Talque, Perf. Beauty Prod. Overton's "High Brown" Face Powder ; ; Early American Old Spice Talcum Powder Bismoline Medicated Powdet Mavis Imported Talcum Avon Beauty Dust Refill - Charisma Plnaud Clubman Talc OH! de London Talc, Yardley Corsage Dusting Powder HHS00000064