Document 5Dk9jLNdddwqQ2yKLKYK31gjN

MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION TO Dr . _Philip P. McGrath, HFB-400 Division of Pathology Electron Microscopy Staff d a t e : March 23, 1979 FROM : Deputy Director, HFF-441 Division of Cosmetics Technology SUBJECT: identification of Cosmetic Samples Analyzed for Asbestos by Scanning Electron Microscopy (SEM). Attached you will find information relative to the identification of talc samples analyzed by your staff last January {see memo dated 1/11/79 Wenninger/Yates). Our analytical results are also summerized in this memorandum. If we can be of further help in this matter let us know. John A. Wenninger Attachments (2) Memos dated 1/12/79 and 1/11/79 MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION to : Dr. Philip P. McGrath, HFB-400 Division of Pathology Electron Microscopy Staff DATe: January 12, 1979 from Deputy Director, HFF-441 Division of Cosmetics Technology subject: Cosmetic Talc Products for Scanning Electron . Microscopy (SEM) Analysis. 1. Under separate cover I am forwarding 6 samples of cosmetic talc products identified by the following FDA sample numbers: INV 77-98-812 INV 77-38-815 INV 77-38-814 INV 77-89-481 INV 77-42-166 INV 77-65-450 2. These samples were analyzed by Division of Cosmetics Technology by X-Ray Diffraction (X-Ray). Samples found to be contaminated with tremolite or anthophyllite by X-Ray were also examined by optical microscopy (OM) to determine crystal morphology. In all cases, the amphiboles found (tremolite and anthophyllite) were present in the massive (non-fibrous) form. Our level of detectability is approximately 0.1% for tremolite and 2% for anthophyllite. None of the samples were found to contain serpentine at a detectability limit of 1-2% (X-ray). 3. These samples are finished talc products and in addition to talc contain other ingredients. Some of the ingredients listed on the labels are: zinc stearate, magnesium carbonate, calcium silicate, mica, titanium dioxide, benzthonium chloride and fragrance. 4. These samples are being submitted for SEM analysis per our discussion on December 14, 1978 at the FDA Asbestos Work Group meeting. As you recall Dr. Asher also is interested Page 2 - Dr. Philip McGrath in having these samples analyzed by SEM. If fibers are noted by SEM it is important that the samples also be examined by energy dispersive x-ray analysis (EDXA) to determine the nature of any fiber like particles detected. yoU have anY questions you may contact me on 245-1061. John A. Wenninger MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION to - John A. Wenninger, HFF-441 Deputy Director Division of Cosmetics Technology date: January 11, 1979 from : Ronald L. Yates, HFF-446 Product Composition Branch, DCST subject: Talc Samples for Analysis by Scanning Electron Microscopy (SEM) for Amphibole and Serpentine Fibers. The following talc samples are submitted to you for conveyance to Dr. Philip McGrath, HFB-400, for analysis by SEM to determine presence of amphibole and serpentine or other fibers of mineral origin: Sample No. INV 77-98-812 INV 77-38-815 INV 77-38-814 INV 77-89-481 INV 77-42-166 INV 77-65-450 Brand Green Apple Talcum Powder Mennen Shave Talc Mennen Bath Talc Satin Talc Mavis Superfine Talc Johnson's Baby Powder Manufacturer Code Village Bath 00272 products Mennen Co. 29KD Mennen Co. 19JD Avon Products 30331 Vivadou, Inc. Dist. Johnson and Johnson GO 96 Samples INV 77-38-814 and INV 77-98-812 contained 0.5 and 0.3% tremolite respectively by x-ray diffractometry. Sample INV 77-89-481 contain a trace of anthophyllite by Page 2 - John A. Wenninger x ray diffractometry. The above samples were also analyzed by optical microscopy (OM) to verify identification and to determine crystal morphology. In all cases, the amphibole was present in the massive (non-fibrous) form. No amphibole minerals were detected in samples INV 77-38-815, INV 77-42-166 and INV 77-65-450 by x-ray diffractometry. Level of detection is approximately 0.1% for tremolite and 2% for anthophyllite. Serpentine was not present in any of the above samples at detection limit of 1-2% (X-ray diffractometry). Ronald L. Yates (b)(5)