Document 3NZqLyv78o7pL32vxowao9Gjn

uon DOMESTIC OPERATING COMPANY N E W B R U N S W I C K , N. J. 0 8 9 0 3 December 29, 1975 Mr. 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 asbes tiform 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 maximum length of a fiber to be counted is 30 microns. d. The length to width ratio 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. JAN 14 376 G. W. SANDLAND Analysis of.FDA Samples for Asbestiform Amphibole FDA Code #DCST 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 1350 1351 1352 Amphibole X-ray. Diffraction Trace Trace Minor Minor Trace Minor Minor Minor None Detected Trace Minor None Detected Minor None Detected None Detected Asbestiform Amphibole Dispersion Staining/ Optical Microscopy * * 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/Fail 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 - 107. (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. Mr. Davis also requested that serpentine analysis be performed on several samples. Sample DCST 1339 was found to contain approxi mately l/o 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. (b) (5) F. Robert Rolle, P h .D . Chairman, CTFA Task Force on Methodology for the Detection of Asbestos Talc