On January 05, 2023 a
Exhibit,Appendix
was filed
involving a dispute between
Dan Albasry
As Trustee Of The Estate Of Newal Al Saad,
Firas Mohammad,
and
Barretts Minerals Inc.,
Beacon Cmp Corp.,
Brenntag Specialties Llc,
Charles B. Chrystal Company Inc.;,
Colgate Palmolive Co.;,
Conopco Inc.,
Glaxosmithkline Consumer Healthcare Holdings,
Glaxosmithkline Llc,
Gsk Consumer Health Inc.,
Lornamead Inc.,
Pfizer Inc.,
Port Jervis Laboratories Inc.,
The Procter & Gamble Co.,
Whittaker, Clark & Daniels Inc.,
Yardley Of London Inc.,
Yardley Of London Ltd.,,
for Torts - Asbestos
in the District Court of New York County.
Preview
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023
EXHIBIT 28
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023
· .. x
The 'Cosrnetic, Toiletry and Fragrance Association, Inc.
1625 EYE STREET, N.W., WASHINGTO/l." D. C. 20006 2021393-2070 James H. Merritt
President
Norman F. Estrin, Ph.D.
Vice Plesiden/~Sc;ef1ce
October' II, 1973
~r..
MIN UTE S
CTFA SUBCO}lliITTEE OF SAC ON ASBESTOS IN TALC
The first meeting of the CTFA Subcommittee of the Scientific Advisory
Committee, on Asbestos in Talc, was held on October 4, 1~73 at the
Colgate Palmolive Research Center, Piscataway, N.J. Those in attendance
were:
Mr. "George Sandland, Bristol-Myers Products (Chairman)
Dr. Murray Berdick, Chesebrough-Ponds, Inc.
Dr. George Cohen, Bristol-Myers Products-
Dr. Christopher Costello, Colgate Palmolive Company
Mr. Salvatcre Di Bianca, The Mennen Company
Mr. John Facq, Colgate-Palmolive Company
Dr. David Hamer, Johnson & Johnson
Mr. Ray R. Krammer, ~~ittaker, Clark and Daniels
Dr. Robert Rolle, Johnson & Johnson
Mr. Fred Roesch, \~ittaker, Clark anrl Daniels
Dr. Joseph P. Simko, Jr., Colgate-Palmolive Company
Dr. John Travers, Avon Products, Inc.
Mr. Ronald Yakupcin, Kolmar Laboratories, Inc.
The meeting began with a discussion of the optical microscopic method
for detecting as)estos in talc, which was published in the Federal Register
of September 28, 1973.
The method, as written, is not completely reliable and discriminatory,
since fibers other than chrysotile might fall within the critical range
of refractive indices used. Cellulose fibers, for instance,would be counted
according to thE; method guidelines. .
It is estimated by at. least two academic sources, that the running
of a single sample would take at least six hours for a count and a tenta-
tive identification. The tedium effect on the person counting is obvious.
Several e~~~rts including Walter McCrone agree that there are probably
----;a---tcrta-l--uf--2fJ-Ill±"crm,cu15iHLs-rn:- -r-h--e-tJni"teC!---Sral:e:s--wno -w5ula---De--suffrcr-erirry--~------
qualified to do the analysis. .
i
.i
i
i
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023
-2-
CTFA SUBCOMMITTEE OF SAC ON ASBESTOS IN TALC
It was generally agreed that with some modification the methodology
could be strengthened to yield a more reliable identification and measure-
ment.
A major consideration in the method is the extremely small sample,
one milligram in size, which one must ,tI0re over for several hours, then
based on the nature of this miniscule 'sample, make a judgment on a 20
ton lot. Bearing in mind the fact that most talc is produced by a con-
tinuous process, the reliability of a one milligram sample is poor, even
if taken froIT. a composite of several samples, since homogeneity of the
sample is extremely difficult to achieve without changing fiber length.
A discussion of the step scanning X-ray diffraction procedure fol-
lowed ,olith a description by Joseph Simko of the method which ,.;as developed
at Colgate. In contrast to optical microscopy, the X-rayOmethod has a
lmver limit of detection of O.S%. It is considera.bly more reliable for
discriminating chrysotile and tremolite and uses a 500 milligram sample,
thus providing TIillch greater statistical assurance that the sample is
representative. It takes about 3 hours to run including manual compu-
tation of results.
It was agreed that we run a "round robin" test using six samples of
sources in the United States and including Italian
.....•... t.."0. furnish a set of which will be "seeded"
eity. These are intended to assist in optical recognition mid to estimate
reproducibility of procedure.
The following eight volunteered to test (or have tested) samples by
optical microscopy (Fed. Reg. 9/28/73) and those designated by asterisk
will also test by the X-ray diffraction step scannin~ method used by
Colgate.
Dr. Murray Berdick, Chesebrough Ponds
Dr. George Cohen, Bristol-Myers Products
*Dr. Christopher Costello, Colgate-Palmolive Company
Mr. Salvatore diBianca, The Mennen Company
*Dr. DeWitt Petterson, Johnson & Johnson
Mr. Fred Roesch, ~bittaker, Clark and Daniels
Dr. John Travers, Avon Products, Inc.
Hr. Ronald Yakupcin, Kolmar Laboratories, Inc.
George Sannland ,viII prepare, code and dis tribute the samples to
the ahove list of persons.
It was also a.greed that George Cohen will contact Pfizer to encourage
______on_ on omn_un _ ~o~~ rif i p at;i,Qn. .:i-.!l .t::.h~ o}~91:j(__ 9J !lL~o s,;:9l1lom:i-_1:;tg~!n_ _ __ u_nn n _ __ _ H
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023
-3-
CTFA SUBCOMMITTEE OF SAC ON ASBESTOS IN TALC
The Committee wishes to approach the evaluation of the FDA proposed
optical microscopic with an open mind and recommends withholding the
critical commenting in these notes until a fair evaluation through
the "round robin" is completed. .""
Following the meeting, several members of the Committee visited
the instrument facilities at Colgate to see the X-ray and optical units.
We wish to thank Dr. Costello and Colgate for permitting us to use
their facilities for this meeting. Dr. Costello also offered to accomo-
date us for future meetings.
Respectfully submitted to the
Scientific Adv.isory Committee,
. "
.. ~
.
.' !'
c
;I
.., r ...
George W. Sandland, Chairman
GWS:dd
,.
Preview
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023 EXHIBIT 28 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023 · .. x The 'Cosrnetic, Toiletry and Fragrance Association, Inc. 1625 EYE STREET, N.W., WASHINGTO/l." D. C. 20006 2021393-2070 James H. Merritt President Norman F. Estrin, Ph.D. Vice Plesiden/~Sc;ef1ce October' II, 1973 ~r.. MIN UTE S CTFA SUBCO}lliITTEE OF SAC ON ASBESTOS IN TALC The first meeting of the CTFA Subcommittee of the Scientific Advisory Committee, on Asbestos in Talc, was held on October 4, 1~73 at the Colgate Palmolive Research Center, Piscataway, N.J. Those in attendance were: Mr. "George Sandland, Bristol-Myers Products (Chairman) Dr. Murray Berdick, Chesebrough-Ponds, Inc. Dr. George Cohen, Bristol-Myers Products- Dr. Christopher Costello, Colgate Palmolive Company Mr. Salvatcre Di Bianca, The Mennen Company Mr. John Facq, Colgate-Palmolive Company Dr. David Hamer, Johnson & Johnson Mr. Ray R. Krammer, ~~ittaker, Clark and Daniels Dr. Robert Rolle, Johnson & Johnson Mr. Fred Roesch, \~ittaker, Clark anrl Daniels Dr. Joseph P. Simko, Jr., Colgate-Palmolive Company Dr. John Travers, Avon Products, Inc. Mr. Ronald Yakupcin, Kolmar Laboratories, Inc. The meeting began with a discussion of the optical microscopic method for detecting as)estos in talc, which was published in the Federal Register of September 28, 1973. The method, as written, is not completely reliable and discriminatory, since fibers other than chrysotile might fall within the critical range of refractive indices used. Cellulose fibers, for instance,would be counted according to thE; method guidelines. . It is estimated by at. least two academic sources, that the running of a single sample would take at least six hours for a count and a tenta- tive identification. The tedium effect on the person counting is obvious. Several e~~~rts including Walter McCrone agree that there are probably ----;a---tcrta-l--uf--2fJ-Ill±"crm,cu15iHLs-rn:- -r-h--e-tJni"teC!---Sral:e:s--wno -w5ula---De--suffrcr-erirry--~------ qualified to do the analysis. . i .i i i FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023 -2- CTFA SUBCOMMITTEE OF SAC ON ASBESTOS IN TALC It was generally agreed that with some modification the methodology could be strengthened to yield a more reliable identification and measure- ment. A major consideration in the method is the extremely small sample, one milligram in size, which one must ,tI0re over for several hours, then based on the nature of this miniscule 'sample, make a judgment on a 20 ton lot. Bearing in mind the fact that most talc is produced by a con- tinuous process, the reliability of a one milligram sample is poor, even if taken froIT. a composite of several samples, since homogeneity of the sample is extremely difficult to achieve without changing fiber length. A discussion of the step scanning X-ray diffraction procedure fol- lowed ,olith a description by Joseph Simko of the method which ,.;as developed at Colgate. In contrast to optical microscopy, the X-rayOmethod has a lmver limit of detection of O.S%. It is considera.bly more reliable for discriminating chrysotile and tremolite and uses a 500 milligram sample, thus providing TIillch greater statistical assurance that the sample is representative. It takes about 3 hours to run including manual compu- tation of results. It was agreed that we run a "round robin" test using six samples of sources in the United States and including Italian .....•... t.."0. furnish a set of which will be "seeded" eity. These are intended to assist in optical recognition mid to estimate reproducibility of procedure. The following eight volunteered to test (or have tested) samples by optical microscopy (Fed. Reg. 9/28/73) and those designated by asterisk will also test by the X-ray diffraction step scannin~ method used by Colgate. Dr. Murray Berdick, Chesebrough Ponds Dr. George Cohen, Bristol-Myers Products *Dr. Christopher Costello, Colgate-Palmolive Company Mr. Salvatore diBianca, The Mennen Company *Dr. DeWitt Petterson, Johnson & Johnson Mr. Fred Roesch, ~bittaker, Clark and Daniels Dr. John Travers, Avon Products, Inc. Hr. Ronald Yakupcin, Kolmar Laboratories, Inc. George Sannland ,viII prepare, code and dis tribute the samples to the ahove list of persons. It was also a.greed that George Cohen will contact Pfizer to encourage ______on_ on omn_un _ ~o~~ rif i p at;i,Qn. .:i-.!l .t::.h~ o}~91:j(__ 9J !lL~o s,;:9l1lom:i-_1:;tg~!n_ _ __ u_nn n _ __ _ H FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 113 RECEIVED NYSCEF: 07/10/2023 -3- CTFA SUBCOMMITTEE OF SAC ON ASBESTOS IN TALC The Committee wishes to approach the evaluation of the FDA proposed optical microscopic with an open mind and recommends withholding the critical commenting in these notes until a fair evaluation through the "round robin" is completed. ."" Following the meeting, several members of the Committee visited the instrument facilities at Colgate to see the X-ray and optical units. We wish to thank Dr. Costello and Colgate for permitting us to use their facilities for this meeting. Dr. Costello also offered to accomo- date us for future meetings. Respectfully submitted to the Scientific Adv.isory Committee, . " .. ~ . .' !' c ;I .., r ... George W. Sandland, Chairman GWS:dd ,.