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C olorado School of M ines R esearch P.O.

Johns-Manville Products Corporation G reenw ood Plaza Denver, Colorado 80217 (303) 770-1000 December 21, 1973 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fischers Lane Rockville, Maryland 20852 CERTIFIED MAIL RETURN RECEIPT REQUESTED Dear Sir: I am responding in behalf of Johns-Manville Products Cor poration ("J-M") to the Food and Drug Administration's (FDA) Notice of Proposed Rule Making relating to asbestos particles in food and drugs, as published in the Federal Register on September 28, 1973 (hereinafter referred to as the "Proposal").

PLAINTIFFS EXHIBIT CAM-13 National Bureau of Standards Special Publication 506.

Cyprus Mines Corporation 555 South Flower Street Los Angeles, California 90071 Telephone 213) 489-3700 Cable Selmud Losangeles Telex 67-4&01 CONFIDENTIAL Mr.

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.w m V D U DEPARTMENT OF HEALT: .DUCATION, AND WELFARE PUBLIC HEALTH SERVICE CDC, National Institute for Occupational Safety and Health TO Hearing Clerk Food and Drug Administration from : SUBJECT: Director, National Institute for Occupational Safety and Health Proposed Regulation on Asbestos Particles in Food and Drugs The proposed regulation on asbestos particles in food and drugs, described in the Federal Register of September 28, 1973 (21 CFR Parts 121 and 133), has been reviewed and comments are offered.

f THE UPJOHN COMPANY K A LA M A ZO O , M IC HIG A N 49001 TELEPHONE (616) 382-4000 M EDICAL SERVICES Office of KENNETH B HAAS D V M July 13, 1976 Hearing Clerk Food and Drug Administration Room h-SS 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: In compliance with the Federal Register Notice, Volume 40, Number 51, March lA, 1975, page 11865, titled "Asbestos-form Particles in Drugs for Parenteral Injection", we are supplying the attached memo as an updated report for replacement of asbestos filters.

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DETECTION OF ASBESTIFORM AMPHIBOLE IN TALC FOR COSMETIC USE The method for the detection of asbestiform ' amphibole in talc for cosmetic use consists of initial analysis for amphibole minerals above the 0.5% (w/w) level, followed by characterization of the amphibole m ineral present, if any, as asbestiform or nonasbestiform by dispersion staining/optical m icroscopy.

*-------- -------- ------ 1 FY: 1974 DATE: 9/6/73 "-ogram: COSMETICS PPE USE ONLY 00679 # Subprogram: Aerosols & Hair Preparations rroject litle: Asbestos and Other Contaminants in Talc Project Manager 6 Mailing Symbol : John Stuart (BF-446) Statement of Obi active: Develop one or several methods of sufficient sensitivity and reliability which will permit the determination of asbestos and other contaminants in talc-containing products with the necessary degree of accuracy and at concen trations at which such contaminants present a potential health hazard. -- ------- * The inhalation of certain asbestiform minerals is a known health hazard.

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TALC A N D CHLORITE D E P O S IT S IN MONTASIA by Richard B.