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  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
  • Patsy Young v. Aventis Inc., Avon Products, Inc., Block Drug Company, Inc. (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Block Drug Corporation (Sued Individually And As Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Brenntag North America, Inc. (Sued Individually And As Successor-In-Interest To Mineral Pigment Solutions, Inc. And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Brenntag Specialties, Inc. F/K/A Mineral Pigment Solutions, Inc. (Sued Individually And As Successor-In-Interest To Whittaker Clark & Daniels, Inc.), Charles B. Chrystal Company, Inc., Chattem, Inc. (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company), Colgate-Palmolive Company, Cyprus Amax Minerals Company (Sued Individually, Doing Business As, And As Successor To American Talc Company, Metropolitan Talc Co. Inc. And Charles Mathieu Inc. And Sierra Talc Company And United Talc Company), Cyprus Mines Corporation, Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A/K/A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And NOVARTIS CONSUMER HEALTH INC.), Gsk Consumer Health, Inc. F/K/A Novartis Consumer Health Inc. F/K/A Ciba Self-Medication, Inc., Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc., Insight Pharmaceuticals Llc, Macy'S Inc. F/K/A/ Federated Department Stores, Inc. (Sued Individually And As Successor-In-Interest To Twin Fair, Inc.), Novartis Corporation (Sued Individually And As A Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiaries Ciba Consumer Pharmaceuticals And Ciba Self-Medication, Inc.), Novartis Pharmaceuticals Corporation (Sued Individually And As Successor-In-Interest To Ciba-Geigy Corporation And Its Subsidiary Ciba Consumer Pharmaceuticals), Prestige Brands Holdings, Inc., Prestige Consumer Healthcare Inc. F/K/A Prestige Brands, Inc., Sanofi-Aventis U.S. Llc (Sued Individually And As Successor By Merger To Aventis Pharmaceuticals Inc.), Sanofi Us Services, Inc., Whittaker Clark & Daniels, Inc.Torts - Asbestos document preview
						
                                

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FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 EXHIBIT 153 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 MASTER EXHIBIT 40 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 - ' 'I • .-, I ' t ' " i •. ' ~ • " ! ' ~ •I ' f · • L'liCil\JO llhno.~. 60616 December 20, 1973 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fishers Lane Rockville, Maryland 20852 Subject: Comments on Proposed Standards for Asbestos Particles in Talc. Dear Sir: The Federal Register (Vol 38, No. 188, Friday, September 28, 1973) listed proposed standards limiting the quantity of asbestos in talc used for foods & drugs. The proposed standards state that, "A count of not more than 1000 amphibole types of asbestos fibers and not more than 100 chrysotile asbestos fibers per milligram-slide constitutes the maximum limit for the presence of these asbestos fibers in talc. These limits assure a purity of talc at least 99.9 percent free of amphibole types of asbestos fibers and at least 99.99 percent free of chrysotile asbestos fibers". The percentages listed for each category of asbestos fibers and the number of asbestos fibers per mg do not agree with each other, I present some calculations below for your review with the suggestion that the proftosed standards be modified to bring the "number of fibers' and "percentages" into agreement. Respectfully yours, Ci~~t~~ Research Scientist Fine Particles Research cc: C. Harwood J. Stockham M. Ingber RGD/nh FDA00003069 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 4-.. t , "Asbestos-Fiber" Concentrations in Talc 1. Number of Chrysotile Fibers in 99.99% Pure Talc. 1.1 ·Talc that is 99.99% pure may contain up to 0.01% chrysotile fibers by weight. 1.2 Therefore, one mg of talc can contain as much as 0.11-lg of chrysotile fibers: 1 mg x 0.01% chrysotile fibers = 0.1 1-lg of chrysotile fibers. 1.3 The size and shape criteria applied to asbestos fibers states that the fibers must be 5 1-lm in length or longer and have a length to width ratio of 3:1. This means that a chrysotile fiber would be counted if it were 5 1-lm long and 1. 7 1-lm wide. A chrysotile fiber that is 5 1-lm long by 1.7 1-lm wide, would have a volume of: volume = length x (width) 2 x n 2 2 volume ::: 5 1-lm x (1. 7 1-lm) x n z- volume = 11.349 l-lm 3 = 11.3 l-lm 3 1.4 The weight of a single chrysotile fiber can be calculated from its volume and density (2.5 g/cm 3 ). volume x density = weight To convert the density from g/cm 3 to l-lg/l-lm 3 : 6 b2..g x 10 u,g x 1 cm3 = 2.5 X 10- 6 Wi cm3 g ( 104 !Jm) 3 1-lm 3 Then the weight of a single chrysotile fiber is: 3 -6 -6 11.3 IJID X 2.5 X 10 ug = 28.3 X 10 !Jg l-lm3 -1- FDA00003070 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 '. 1.5 To determine the allowable number of chrysotile fibers in talc divide the allowable weight of chrysotile fibers by the weight of a single chrysotile fiber: Allowable wt/wt of single fiber = no. of fibers 0.11-lg/28.3 x 10- 6 1-Lg/fiber = 3,534 fibers 1.6 The above calculations show that a 99.99% pure talc can contain as many as 3,500 chrysotile fibers per mg instead of the 100 chrysotile fibers cited in the proposed standard. 2. Number of Amphibole Fibers in 99.9% Pure Talc. The calculations below follow the same outline pre- sented for chrysotile fibers in talc. 2.1 Wt. Percent allowable amphibole fibers: = 0.1% 2.2 Wt. of amphibole fibers in one mg of talc. 1 mg x 0.10% = 0.001 mg = 1.0 1-Lg 2.3 Volume of an amphibole fiber. (Amphibole fibers may be lath-like instead of cylindrical, therefore, their volume is computed from;) 5 IJID X 1. 7 1-J.m ~ 1. 7 ~Jffi = 14.5 1Jm3 2.4 Wt. of a single amphibole fiber (density taken as 3.3 g/cm 3 or 3.3 x 10- 6 ~) 3 IJ.ffi 6 14.5 IJID 3 X 3.3 X 10- ~ = 47.9 X 10- 6 IJ.g IJID3 2.5 Allowable number of amphibole fibers in pure talc; 1. 0 1-Lg/47. 9 x 10- 6 IJ.g = 20,876 fibers 2.6 The above calculations show that a 99.9% pure talc can contain as many as 20,000 amphibole fibers per mg instead of the 1000 amphibole fibers cited in the proposed standard. -2- FDA00003071 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 • 3. · • Discussion The calculations above were based on the presumption that all the chrysotile or amphibole fibers in a hypothetical talc sample were 5 ~m long. It is very unlikely that this would occur in practice. However, it may not be valid to cite any percentage purity for a given number of mineral fibers without knowing their size distribution. For example, the proposed standards for purity and number of fibers calculates to a weight average length of 16 ~m and 14 ~m respectively for chrysotile and amphibole fibers. Perhaps the simplest way of resolving the(obviously unintended) contradiction is to drop the percentage purity values and rely solely on the number of fibers in a given weight. -3- FDA00003072 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 McGIVNEY & KLUGER, P.C. 2J VREELAND ROAD TWO PENN CENTER PLAZA SUITE220 80 BROAD STREET 15~&J.F.K. BOULEVARD FLORHAM PARK. ~J 07932 23RDFLOOR SU1TE518 TELEPHONE (973) 822-1110 PHILADELPHIA, PA 19102 FACSIMILE (973) 822-1116 NEW YORK, NY 10004 TELEPHONE (215) 557-1990 FACSIMILE (215) 557-7590 ONE STATE STREET TELEPHONE (212) 509-3456 SUITE800 BOSTON, MA 02109 FACSIMILE (212) 509-4420 2 BATTERSON PARK ROAD TELEPHONE (617) 72.1-S888 FACSIMILE (617) 723-5899 www.mcgivncyandkluger.com FAR\UNGTON, CT 06032 TELEPHONE (860) 404-3000 FACSIMILE (860) 409-0754 PLEASE RESPOND TO: ONE LINCOLN CENTER SUITE 1010 ONE COMMERCE CENTER 110 WEST FAVETTE STREET NEW YORK OFFICE SYRACUSE, NY 1.1202-1306 SUITE 501 TELEPHONE (315) 473-9648 1201 ORANGE STREET FACSIMILE (315) 473-9654 WILMINGTON, DELAWARE 19801 TELEPHONE (302) 656-1200 FACSIMILE (302) 656-1220 191 WOOD PORT ROAD SUITE210B October 30, 2009 SPARTA, NJ 07871 TELEPHONE (973) 726-4958 72 PINE STREET FACSIMILE (973) 726-0432 1ST FLOOR PROVIDE~CE, RI 02903 TELEPHONE (401) 272-5300 FACSIMILE (401) 331-7454 Food and Drug Administration Division of Freedom oflnformation (HFI-35) Office of Shared Services Office ofPublic Information and Library Services 5600 Fishers Lane Rockville, :MD 20857 Re: Talc and Asbestos Please provide a complete copy of all documents and information including but not limited to records, minutes, reports, articles, correspondence, petitions, memorandums, notes, pictures, diagrams, photographs, publications, and rulings relating to the following: • the presence of asbestos in talc; • Cashmere Bouquet talcum powder; • Cosmetic talcum powder/cosmetic talc and; • The Colgate-Palmolive Company (formerly know as Colgate & Co. and Colgate-Palmolive-Peet Co.). In addition, please provide a complete copy of all documents and information including but not limited to records, minutes, reports, articles, correspondence, petitions, memorandums, notes, pictures, diagrams, photographs, publications, and rulings relating to the biological and pathological effects of talc. Please do not hesitate to contact the undersigned with any questions you may have. Please confirm receipt ofthis message. FDA00003789 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023 Dated: New York, NY October 30, 2009 Very truly yours, Eli Granek McGivney & Kluger, P.C. 80 Broad Street, 23rd Fl New York, NY 10004 Phone: (646) 520-2100 Fax: (212) 509-4420 Email: egranek@mcgivneyandkluger. com FDA00003790 FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 365 1/22/2018 RECEIVED RONALD DRAFTZ Obituary: RONALD DRAFTZ's Obituary by the Daily Herald. NYSCEF: 03/17/2023 RONALD G. DRAFTZ ..--17' Gl UeL.Keft Ronald G. Draftz of Arlington Heights Ronald G. Draftz was born March 10, 1937, in Chicago, to Theodore and Marie (nee Sowinski) Draftz. He went to his forever home to be with our Lord on il!li$!l!it.'l~M~t:1~~l~~ Saturday, Aug. 20, 2011, from Waldenstrom's macroglobulinemia, a bone marrow cancer at his home in Arlington Heights, surrounded by his family. Mr. Draftz was a research scientist at liT Research Institute. He loved his family and cherished his time with his grandchildren. He enjoyed taking photos of family, friends, weddings and celebrations. He is survived by his loving wife, Germaine Draftz (nee Wiora); his beloved children, Angelique (Rich Skubis) Draftz, Aimee Draftz and David (Ginny) Draftz; and his adoring grandchildren, Lauren, Mattie, Mary, Anna, Kate, Teddy and Ben. Ronald was preceded in death by his parents. Visitation will be from 3 until 9 p.m. Thursday, Aug. 25, at the Glueckert Funeral Home, Ltd., 1520 N. Arlington Heights Road (four blocks south of Palatine Road), Arlington Heights, and on Friday, Aug. 26, from 10 a.m. until the time of the funeral Mass at 11 a.m. at St. Edna Catholic Church, 2525 N. Arlington Heights Road, Arlington Heights. A private family interment will be in St. Michael the Archangel Cemetery. A special thank you to Dr. Bruce Bank, his nurse Kelly, and the office staff. Also, thank you to the special angels of mercy, the nurses and staff at NCH Infusion Center. In lieu of flowers, memorial contributions may be given to International Waldenstrom's Macroglobulinemia Foundation, 3932 D Swift Road, Sarasota, FL 34231. For funeral information and condolences, www.GiueckertFH.com or 847-253-0168. Published in Chicago Suburban Daily Herald on Aug. 24, 2011 http ://wvvw.legacy.com/obituaries/dailyherald/obituary-print.aspx?n=ronald-g-draftz&pid=153268122 1/1