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 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
EXHIBIT 19
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
MASTER EXHIBIT 34
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
-REPORT 9F CTFA TALC SUBCOMMITTEE ON METHOD TO DETECT· CHRYSOTILE AND
.TREMOLITE IN TALC,
December 10, 1973
I j
The $cientific Advisory Committee of the Co~etic, Toiletry &
FragranceiAssociation, 1625 Eye Street, N.W,, Wa5hington, D.C. 200061
at a meeting held on September 2, 1973, designat;d that a subcommitt'e il
be set.uplto study the op~ica~ microscopic metho~ pr~posed by the Food I·
and Drug Administration. This method was published in the Federal iI:
Register •f September 28 1 1973. The present member~hi~ of the CTFA
rale Subcommittee is shown·on an attached sheet;
.. At the. firs.t l)leeting of the Subconnni ttet>, it was agreed to sublll;it
several sampJ.ea of talc to membe+s who vnlunteered to apply the FDA
proposed optical microscopic method', The foll:>wing talc samples were
distributed without identification- except for randomly.applied and
non-duplicated code numbers:
Italian Talc
Montana Talc
Montana Talc Source I
Vermont Talc Source I+
Al.aba.ma Talc. .
No. Carolina Talc
In addition, a sample of Italian Talc spiked wh~ with 1% chryaotile
and 0.15% tremolite was sent to each participant. The purticip~nts
were aware that the sample was spike~, but ~id not know the percentage
of spiking.
The attached table summarizes all reports submitted:
Final Report
WCD000115
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NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
~2-
No~ of Fibers No. of Fibers ·Status With
With R.I. Greater With R.I. Less Regard to Pro~
Samele Than 1590 Than 1574 Eoaed FDA Method
Mrs,·Lucz McCrone 2 McCrone Associates fo:r .Cbeseb:t:oush
ISpiked
Italian
?20
Jl20 11~ Pdsses
P~sses
:Montana- I 0 0 Passes
Alabama 0 0 Passes
Vermont 0 0 Passes
No.Ciirol:in11 0 0 Ptuises
Montana- II .0 0 Passes
Mr. Harold Stanley of Pfizer
Italian ,.....100 >100 Fails Chrysotile
Passes tremolita
Montana- r· -100 )100 Fails Chrysotile
Passes tremolite
Montana'- II -1oo >lOO Fails Chrysotile
Passes tremolite
Alabama ,....... 100 >.100 ·Fails Chrysotile
Passes tremolite
Vermont ""' 100 ~100 Fails Chrysotile
Passes tremolite
No. Carolina rw100 >100 Fa.ils Chrysotile
~asses tremolite
Spiked (1000 )100 Fails Chrysotile
Passes tremolite
Mr. David Hamer of Johnson & Johnson
Italian 0 0 Passes
Montana- I 1 0 Passes
Montana- II 25 .Q Passes
Alabama 0 0 Passes
Vermont 0 0 Passes
No. Carolina 0 0 Passes
Dr. J.ohn A. Reffner (U. of Conn.). for Avon
Spiked 632
-. 12,930 Fails Chrysotile
Passes Tremolite
Italian 220 1,114 Fails Chrysotile
Passes Tremolite
WCD000116
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
-3-
No. of Fibers No. of Fibers Status ~vith
With R.!; Greater With R. I r Less Refla-rd to Pro-
·Sa!J!Ple ,. ·Than 1590 Than· 1574 Eosed FDA Method
~1,;· John A. Reffner (U. of Conn.) for Avon Cont'd
I
.Montana-I 0 5,844 Fails chrysotile
Passes tremolite
Montana-II 13 9,281 Fails ch:rysotiile
Passes tremo~te
Alabama '26 15,125 Faile ch:rysoti!,le
Passes tremolite
Vermont
. 41 165 Faile chryaotile
Passes tremolita
No. ·Carolina 14' 11,852 Faihr ·chrysotile
Passes tremolite
Dr. T.ryggve Baak of United Sierra
Spiked 3.000 2,000 Fails
Italian 1;000 0 l?asses
:Hontana-I 0 0 Passes
Montana-II 0 0 Passes
Alabama 0 0 Passes
Vermont 0 0 'Passes
No, Carolina 500 0 Passes
Richard E. Stevens of Ernest F. Fullam 2 Inc. for Whitteker-C&D
Italian 8,250 1,350 Falls ch:rysotile & tremcilite
Montana- I 18;00() 450 Fails ch:rysotile & tremolite
Motltana-II 29 ;250 5,200 Fails chrysotile & tremol:ite
Alabama 21,825 6,075. Fails chrysotile & ·tremolite
Vermont 3,225 675 Fails chrysotile & cremolite
No. Carolina 20,850 6,000 Fails chrysotile & tremolite
Spiked sample was not run.
-·.
WCD000117
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
-4-
No. of Fibers No, of Fibers S.tatus With
With R.I. Greater With R.I. Less Regard to.Pro-
Than'l590 Than 1574 po~ed FDA'Method
Mrs, Lucy McCrone of McCrone •Associates for Kolmar
i
'Italian
M~ntana-I
~3
:o
o,
0·
P~eses
I' asses
J
Mus particles".
2. The innne·:sion method for the determination of'relative refra.ctive'
index be!omes unreliable when applied to extremely small (ca.
1 pm)par;icles. This is due in part to ttie fact that particles
around l:Jllll- in width approach the liinit of resolution of. the
huinan ey,~ when both size and contrast are considered, especially.
when applyi?g the B'ecke line technique prescribed. Thifi '·rill'
WCD000118
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
·~
-5-
2, cause eye fatigue.and rssulting arro~s. Thus, a fine talc
shat:d or pJ.ate on edge may be easily mistakey; for an asbestos
fiber,. This applies to both the.chrysotile and amphibole
- portions of the test. ·
3. It is quite likely that chlorite ~a mineral of varied compo-
sition commonl~ found in pharmaceutical grade talc - wo~ld
;
be incorrectly identified as tremolite. Refractive indices
for lhlorite vary in the~range 1.57-1.662.
4. The examination of a sample of one milligram' dispersed on a
single microscope slide presents· the investigator with a
preparation which· ia too dense fo.r a petrographi,c .s.tud:y.
5. The method is.laborious and time consuming. Dr, Reffner
quotes .an analysis time of about five hours per sample and
at JOHNSON & JOHNSON the investigator (D. H. ~er). estimated
a..t least two or three hours •
6, Dr. Walter C. McCrone in an earlier letter to the FDA suggested
that there were relatively few scientists in the country who
couJ.d use the method effectively. Scientists at Bristol-Myers,
The Mennen Company,·Liberty Mutual and. Colgate~Palmolive had
great difficulty in following the method to conclusion.
7. The proposed FDA method implies that all fibrous particles in
talc having optical properties similar to those of asbestos
minerals are in fact asbestos. This is probably an unwarranted
SSSUlllption.
REFERENCES:
1, Deer, W.A., Howie, R.A., and Zussman, J,, Rock-Forming Minerals,
Vol. 3, p. 12~ (1962).
2, ibid, P• 131.
*****************
We have concluded that the method published in the Federal Register
does not provide a truly reliable means for tho detection of asbestos in
talc. It reaul~s in both false-positive' and false-negative findinss. It
is also tedious and may consume as much as one half day per sample.
The subcommittee urges that the Food and Drug Administration de~er
finalizing the proposed optical microscopic method and proceed into a
Phase II program which would comb~ne FDA and ~ndustry in a strong effort
to develop a truly reliable method for measuring chrysotile content in
talc. '~e are confideRt that the detection and estimation of fibrous
tremolite can also be done, if necessary, as a fringe benefit, at the sarnn
time,
WCD000119
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
-6-
We estimate tl1at a 'satisfactory method will take at least six
months to a year. to develop. We suggest· a close liais.on between FDA
:and industry in this all-out effort with updating· reviews to take
place as fre~uently as necessary.
Review' of Alternate Methods
The CTFA Ta~c Subcommittee has ~eviewed
several methods to detect
chrysotile and t~emolite in talc, in~luding modificationf of the optical
microscop~c method, Xheee are listed with comments.· ·
1. Optical Microscopic Method - may ·be ·us.ed. with s~me mod;ifi~.a.tion.
Possibly hetter selection of R.I. liquids and reduction of sample
size per slide.
2. X-ray Step Scanning - A good .method for de.tecting tremolite if we·
could accept about 0.2% as the threshold of.detectjon. It does
not distinguish fibrous from non-fibrous tremolite. Th~ simultaneous
detection of chlorite m~kes method impractical for chrysotila.
3. X-Ray Step Scanni~g + Optical Microscopy - Acceptabie· as in #2
above but the ·optical method continues to present the dilemma in
reliabte identification of chrysotile. Rowever, this does not
rule out a major revision of the optical method to do the chrysotile
identificatiori anu countin.g.
4. X-Ray Scanniu.g - The probl~m of chlorite interference in the detection
of chrysotile is present in all x-ray procedures thus far· available,
It is reliable for the detection of 1% tremolite (both fibrous and
non-fibrous) , ·
5. pifferential Thermal Analysis - This procedure is capeble of detecting
chryaotile at the 1% level, however, it w111 not detect tremolite.
6. Scanning Election ~croscopy- This.procecure is not capable of identi-
~ying asbestos. Even with energy dispe~sive analysis, completely
satisfactory identification is not possibJe.
7. Transmission Electron Microscopy+ Blectrcn Diffraction -This
appeaTs to offer the bast, most reliable ~ethod and is probably
capable of detecting chrysotile and tremolite (fibrous), both at
a level of 0,1%, It is estimated that an installation would cost
about $130M+, and is obviously prohibiti~e for the small manufacturer
who uses talc. The amount of talc sample examined by this procedure·
is miniscule.
... .
WCD000120
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
-7-
SullllllarY
The 9TFA Talc Sub~ol!l!l)ittee. has completed i.ts. review of the Optical
Microscopic Method for the Estimation of Chrysotile and Fibrous Tremolite
in Talc, which appeared in th~ Federal Register, vol. 38 (No. 188),(p. 27076,
September 28, 1973). It recommends postponement of the finalization of
the proposed regulat;f..on on talc. In addition·, a collaborative' effort
betwe~n FDA & industry toiresolve a satiafactpry method of estimdting
chrys9tile and tremolite in talc, is recommenjled, with periodic ~iaison
revie~s to monitor the pr9ject status. A taa~ force of industry ;experts
has been designated to pursue alternate methods. We. invite FDA to
~articipate in collaboration with the task force.
• ..
I
GWS:dd
WCD000121
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023
1
••
l;'
!
MEMBERSHIP LIST.- CTFA TALC SUBCOMMITTEE
G. w.• Stmdland, Chairman (SAC) · Dr. DeWitt Pette~son /.
Br1atol-Myere Products Johnson & Johnson Research Center r
Dr. Murray Berdick (SAC) Dr. Robert Rolle
Cbesebrough-Pon4a 1 Inc. Johnson & Jo.hneO:n Research Center
Dr. George Cohed Mr , Fred Roesch !
Bristol-Myers Ptoducts Whittaker, Clar~ and Daniels
I
Dr. Christopher Costello (SAC) Dr. Charles Rowland (SAC)
Colgate-Palmolive Company Avon Products, Inc.
Mr. Salvatore DiBiarica Dr. Harold Sch~!artz
The Mennen Comp~y The Mennen Company
Mr, John Facq Dr. Joseph Simku
Colgate-Palmolive Company Co1gate-Palmolive Company
Mr, David Hamer Mr. Harold U, Stan!ey 1 Jr.
Johnson &. iohns·on Research Center Pfizer
Mr, Alan M. Harvey Mr.· Wallace Steinberg (SAC)
R. T• .Vanderbilt, Inc. Jonnson & Johnson
~~. Ray R. Krammes Dr, John Travers
Whittaker, Clark and Daniele Avon Products, Inc,
Mr.,'· Adolph Marusz~wski· (SAC) Dr. 6. ·s. Tho~pson
Kalmar ·Laboratories, Inc. R. T. VPnderbilt, Inc,
Mr. Louis D, Muriuo Mr. Ronnld Yakupcin
United Sierra Kolmar Laboratories
Dr. Tryt:,gve Baak
United Sierra
I,.
December 11,. 1973
.......
WCD000122
Preview
FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 EXHIBIT 19 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 MASTER EXHIBIT 34 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 -REPORT 9F CTFA TALC SUBCOMMITTEE ON METHOD TO DETECT· CHRYSOTILE AND .TREMOLITE IN TALC, December 10, 1973 I j The $cientific Advisory Committee of the Co~etic, Toiletry & FragranceiAssociation, 1625 Eye Street, N.W,, Wa5hington, D.C. 200061 at a meeting held on September 2, 1973, designat;d that a subcommitt'e il be set.uplto study the op~ica~ microscopic metho~ pr~posed by the Food I· and Drug Administration. This method was published in the Federal iI: Register •f September 28 1 1973. The present member~hi~ of the CTFA rale Subcommittee is shown·on an attached sheet; .. At the. firs.t l)leeting of the Subconnni ttet>, it was agreed to sublll;it several sampJ.ea of talc to membe+s who vnlunteered to apply the FDA proposed optical microscopic method', The foll:>wing talc samples were distributed without identification- except for randomly.applied and non-duplicated code numbers: Italian Talc Montana Talc Montana Talc Source I Vermont Talc Source I+ Al.aba.ma Talc. . No. Carolina Talc In addition, a sample of Italian Talc spiked wh~ with 1% chryaotile and 0.15% tremolite was sent to each participant. The purticip~nts were aware that the sample was spike~, but ~id not know the percentage of spiking. The attached table summarizes all reports submitted: Final Report WCD000115 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 ~2- No~ of Fibers No. of Fibers ·Status With With R.I. Greater With R.I. Less Regard to Pro~ Samele Than 1590 Than 1574 Eoaed FDA Method Mrs,·Lucz McCrone 2 McCrone Associates fo:r .Cbeseb:t:oush ISpiked Italian ?20 Jl20 11~ Pdsses P~sses :Montana- I 0 0 Passes Alabama 0 0 Passes Vermont 0 0 Passes No.Ciirol:in11 0 0 Ptuises Montana- II .0 0 Passes Mr. Harold Stanley of Pfizer Italian ,.....100 >100 Fails Chrysotile Passes tremolita Montana- r· -100 )100 Fails Chrysotile Passes tremolite Montana'- II -1oo >lOO Fails Chrysotile Passes tremolite Alabama ,....... 100 >.100 ·Fails Chrysotile Passes tremolite Vermont ""' 100 ~100 Fails Chrysotile Passes tremolite No. Carolina rw100 >100 Fa.ils Chrysotile ~asses tremolite Spiked (1000 )100 Fails Chrysotile Passes tremolite Mr. David Hamer of Johnson & Johnson Italian 0 0 Passes Montana- I 1 0 Passes Montana- II 25 .Q Passes Alabama 0 0 Passes Vermont 0 0 Passes No. Carolina 0 0 Passes Dr. J.ohn A. Reffner (U. of Conn.). for Avon Spiked 632 -. 12,930 Fails Chrysotile Passes Tremolite Italian 220 1,114 Fails Chrysotile Passes Tremolite WCD000116 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 -3- No. of Fibers No. of Fibers Status ~vith With R.!; Greater With R. I r Less Refla-rd to Pro- ·Sa!J!Ple ,. ·Than 1590 Than· 1574 Eosed FDA Method ~1,;· John A. Reffner (U. of Conn.) for Avon Cont'd I .Montana-I 0 5,844 Fails chrysotile Passes tremolite Montana-II 13 9,281 Fails ch:rysotiile Passes tremo~te Alabama '26 15,125 Faile ch:rysoti!,le Passes tremolite Vermont . 41 165 Faile chryaotile Passes tremolita No. ·Carolina 14' 11,852 Faihr ·chrysotile Passes tremolite Dr. T.ryggve Baak of United Sierra Spiked 3.000 2,000 Fails Italian 1;000 0 l?asses :Hontana-I 0 0 Passes Montana-II 0 0 Passes Alabama 0 0 Passes Vermont 0 0 'Passes No, Carolina 500 0 Passes Richard E. Stevens of Ernest F. Fullam 2 Inc. for Whitteker-C&D Italian 8,250 1,350 Falls ch:rysotile & tremcilite Montana- I 18;00() 450 Fails ch:rysotile & tremolite Motltana-II 29 ;250 5,200 Fails chrysotile & tremol:ite Alabama 21,825 6,075. Fails chrysotile & ·tremolite Vermont 3,225 675 Fails chrysotile & cremolite No. Carolina 20,850 6,000 Fails chrysotile & tremolite Spiked sample was not run. -·. WCD000117 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 -4- No. of Fibers No, of Fibers S.tatus With With R.I. Greater With R.I. Less Regard to.Pro- Than'l590 Than 1574 po~ed FDA'Method Mrs, Lucy McCrone of McCrone •Associates for Kolmar i 'Italian M~ntana-I ~3 :o o, 0· P~eses I' asses J Mus particles". 2. The innne·:sion method for the determination of'relative refra.ctive' index be!omes unreliable when applied to extremely small (ca. 1 pm)par;icles. This is due in part to ttie fact that particles around l:Jllll- in width approach the liinit of resolution of. the huinan ey,~ when both size and contrast are considered, especially. when applyi?g the B'ecke line technique prescribed. Thifi '·rill' WCD000118 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 ·~ -5- 2, cause eye fatigue.and rssulting arro~s. Thus, a fine talc shat:d or pJ.ate on edge may be easily mistakey; for an asbestos fiber,. This applies to both the.chrysotile and amphibole - portions of the test. · 3. It is quite likely that chlorite ~a mineral of varied compo- sition commonl~ found in pharmaceutical grade talc - wo~ld ; be incorrectly identified as tremolite. Refractive indices for lhlorite vary in the~range 1.57-1.662. 4. The examination of a sample of one milligram' dispersed on a single microscope slide presents· the investigator with a preparation which· ia too dense fo.r a petrographi,c .s.tud:y. 5. The method is.laborious and time consuming. Dr, Reffner quotes .an analysis time of about five hours per sample and at JOHNSON & JOHNSON the investigator (D. H. ~er). estimated a..t least two or three hours • 6, Dr. Walter C. McCrone in an earlier letter to the FDA suggested that there were relatively few scientists in the country who couJ.d use the method effectively. Scientists at Bristol-Myers, The Mennen Company,·Liberty Mutual and. Colgate~Palmolive had great difficulty in following the method to conclusion. 7. The proposed FDA method implies that all fibrous particles in talc having optical properties similar to those of asbestos minerals are in fact asbestos. This is probably an unwarranted SSSUlllption. REFERENCES: 1, Deer, W.A., Howie, R.A., and Zussman, J,, Rock-Forming Minerals, Vol. 3, p. 12~ (1962). 2, ibid, P• 131. ***************** We have concluded that the method published in the Federal Register does not provide a truly reliable means for tho detection of asbestos in talc. It reaul~s in both false-positive' and false-negative findinss. It is also tedious and may consume as much as one half day per sample. The subcommittee urges that the Food and Drug Administration de~er finalizing the proposed optical microscopic method and proceed into a Phase II program which would comb~ne FDA and ~ndustry in a strong effort to develop a truly reliable method for measuring chrysotile content in talc. '~e are confideRt that the detection and estimation of fibrous tremolite can also be done, if necessary, as a fringe benefit, at the sarnn time, WCD000119 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 -6- We estimate tl1at a 'satisfactory method will take at least six months to a year. to develop. We suggest· a close liais.on between FDA :and industry in this all-out effort with updating· reviews to take place as fre~uently as necessary. Review' of Alternate Methods The CTFA Ta~c Subcommittee has ~eviewed several methods to detect chrysotile and t~emolite in talc, in~luding modificationf of the optical microscop~c method, Xheee are listed with comments.· · 1. Optical Microscopic Method - may ·be ·us.ed. with s~me mod;ifi~.a.tion. Possibly hetter selection of R.I. liquids and reduction of sample size per slide. 2. X-ray Step Scanning - A good .method for de.tecting tremolite if we· could accept about 0.2% as the threshold of.detectjon. It does not distinguish fibrous from non-fibrous tremolite. Th~ simultaneous detection of chlorite m~kes method impractical for chrysotila. 3. X-Ray Step Scanni~g + Optical Microscopy - Acceptabie· as in #2 above but the ·optical method continues to present the dilemma in reliabte identification of chrysotile. Rowever, this does not rule out a major revision of the optical method to do the chrysotile identificatiori anu countin.g. 4. X-Ray Scanniu.g - The probl~m of chlorite interference in the detection of chrysotile is present in all x-ray procedures thus far· available, It is reliable for the detection of 1% tremolite (both fibrous and non-fibrous) , · 5. pifferential Thermal Analysis - This procedure is capeble of detecting chryaotile at the 1% level, however, it w111 not detect tremolite. 6. Scanning Election ~croscopy- This.procecure is not capable of identi- ~ying asbestos. Even with energy dispe~sive analysis, completely satisfactory identification is not possibJe. 7. Transmission Electron Microscopy+ Blectrcn Diffraction -This appeaTs to offer the bast, most reliable ~ethod and is probably capable of detecting chrysotile and tremolite (fibrous), both at a level of 0,1%, It is estimated that an installation would cost about $130M+, and is obviously prohibiti~e for the small manufacturer who uses talc. The amount of talc sample examined by this procedure· is miniscule. ... . WCD000120 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 -7- SullllllarY The 9TFA Talc Sub~ol!l!l)ittee. has completed i.ts. review of the Optical Microscopic Method for the Estimation of Chrysotile and Fibrous Tremolite in Talc, which appeared in th~ Federal Register, vol. 38 (No. 188),(p. 27076, September 28, 1973). It recommends postponement of the finalization of the proposed regulat;f..on on talc. In addition·, a collaborative' effort betwe~n FDA & industry toiresolve a satiafactpry method of estimdting chrys9tile and tremolite in talc, is recommenjled, with periodic ~iaison revie~s to monitor the pr9ject status. A taa~ force of industry ;experts has been designated to pursue alternate methods. We. invite FDA to ~articipate in collaboration with the task force. • .. I GWS:dd WCD000121 FILED: ERIE COUNTY CLERK 03/17/2023 07:22 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 226 RECEIVED NYSCEF: 03/17/2023 1 •• l;' ! MEMBERSHIP LIST.- CTFA TALC SUBCOMMITTEE G. w.• Stmdland, Chairman (SAC) · Dr. DeWitt Pette~son /. Br1atol-Myere Products Johnson & Johnson Research Center r Dr. Murray Berdick (SAC) Dr. Robert Rolle Cbesebrough-Pon4a 1 Inc. Johnson & Jo.hneO:n Research Center Dr. George Cohed Mr , Fred Roesch ! Bristol-Myers Ptoducts Whittaker, Clar~ and Daniels I Dr. Christopher Costello (SAC) Dr. Charles Rowland (SAC) Colgate-Palmolive Company Avon Products, Inc. Mr. Salvatore DiBiarica Dr. Harold Sch~!artz The Mennen Comp~y The Mennen Company Mr, John Facq Dr. Joseph Simku Colgate-Palmolive Company Co1gate-Palmolive Company Mr, David Hamer Mr. Harold U, Stan!ey 1 Jr. Johnson &. iohns·on Research Center Pfizer Mr, Alan M. Harvey Mr.· Wallace Steinberg (SAC) R. T• .Vanderbilt, Inc. Jonnson & Johnson ~~. Ray R. Krammes Dr, John Travers Whittaker, Clark and Daniele Avon Products, Inc, Mr.,'· Adolph Marusz~wski· (SAC) Dr. 6. ·s. Tho~pson Kalmar ·Laboratories, Inc. R. T. VPnderbilt, Inc, Mr. Louis D, Muriuo Mr. Ronnld Yakupcin United Sierra Kolmar Laboratories Dr. Tryt:,gve Baak United Sierra I,. December 11,. 1973 ....... WCD000122