On December 10, 2020 a
Exhibit,Appendix
was filed
involving a dispute between
Patsy Young,
and
Aventis Inc.,
Avon Products, Inc.,
Block Drug Company, Inc.,
Block Drug Corporation,
Brenntag North America, Inc.,
Brenntag Specialties, Inc. F K A Mineral Pigment Solutions, Inc.,
Charles B. Chrystal Company, Inc.,
Chattem, Inc.,
Colgate-Palmolive Company,
Cyprus Amax Minerals 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.,
Novartis Pharmaceuticals Corporation,
Prestige Brands Holdings, Inc.,
Prestige Consumer Healthcare Inc. F K A Prestige Brands, Inc.,
Sanofi-Aventis U.S. Llc,
Sanofi Us Services, Inc.,
Whittaker Clark & Daniels, Inc.,
for Torts - Asbestos
in the District Court of Erie County.
Preview
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
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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
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FDA00003070
FILED: ERIE COUNTY CLERK 03/17/2023 09:32 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 365 RECEIVED NYSCEF: 03/17/2023
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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
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FACSIMILE (973) 822-1116 NEW YORK, NY 10004
TELEPHONE (215) 557-1990
FACSIMILE (215) 557-7590
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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:
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October 30, 2009
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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