Document 2R31a9oXj813pLGdbj0aErNd6
,Meeting Date: December 7, 1973
Release Date: December 21 1973
M IN C in Meeting of CTFA Talc Subcommittee
Present : Mr. George W, Sandland (Chairman), Bristol-Myers Products Dr, Tryggve Baak Dr. Christopher Costello, Colgate-Palmolive Research Center Mr. John N. Facq, Colgate-Palmolive Research Center Mr. David H, Hamer, Johnson & Johnson Research Center Mr. Allan M, Harvey, R, T. Vanderbilt Company Mr. Raymond R. Kraminea Whittaker, Clark and Daniels Co. Dr. George Lee, Johnson & Johnson Research Center Mr. Louis D. Murino, United Sierra Co. Dr. Wilson Nashed, Johnson & Johnson Research Center Dr. Fred Roesch, Whittaker, Clark and Daniels Co. Dr. F. Robert Rolle, Johnson & Johnson Research Center Dr. John P. Schelz, Johnson & Johnson Research Center Dr. Joseph Slmko Colgate Polmolive Research Center Mr. Harold Stanley, Charles Pfizer Company Dr. John Travers, Avon Producta, Inc.
Mr. Ronald Yakupcin, Kolmar Laboratories, Inc.
The meeting was held in the Colgate-Palmolive Research Center, Plscataway, New Jersey The results of the "round robin" analysis of seven talc samples were discussed. A summary of the data follows:
^ u u tf f ? XHlLT
WCD-399
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t-2-
, Sample
.. No. of Fibers With R.I. Greater Than 1590
No. of Fibers With R.I. Less
Than 1574
Status With Regard to Proposed FDA Method
- Mrs. Lucy MeCrone, McCrone Associates for .Chesebrough
Spiked Italian Montana- I Alabama Vermont No.Carolina Montana- II
320 120
0 0 0
0
0
16 0 0 0 0 0. 0
-
Passes Passes Passes Passes Passes Passes Passes
Mr. Harold Stanley of Pfizer
Italian Montana- I Montana- II Alabama Vermont No. Carolina Spiked
/^-lOO ~ 100
~100
*wl00 w ' 100 /V. 100
<1000
>100 >100 >100 ' >100 >100 >100 >100
Mr, David Hamer of Johnson & Johnson
Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite
'
Italian Montana- I Montana- II Alabama Vermont No, Carolina
0 1
25
0
0
0
0 Passes
0 Passes
0 Passes
0 Passes
0
Passes
1
0 Passes
-Spiked Italian
-* Dr. John A. Refiner (U. of Conn.) for Avon .
632 12,930 *
220 1,114
Fails Chrysotile Passes Tremolite Fails Chrysotile Passes Tremolite
Goodhue WCD 000228
'Sample ,
.Montana-1 Montana-11 Alabama Vermont
ft H o . `Carolina "
-3- .
Ho. of Fibers With R.I.' Greater
Than 1590-
No, of Fibers iith R.l. Less;
Than-1574 `
Status With Regard to Pro posed- FDA Method
Sr. John A. Refiner (U. of Conn.) for Avon Cont'd-
0 13 26 41 14 '
5,844 9,281 15,125
165 11,852
Fails chrysotile Passes tremollte - Fails chrysotile Passes tremolite Fails chrysotile Passes tremolite Falls chrysotile ` Passes tremolite Fails chrysotile Passes tremolite
Sr. Tryggve Baak of United Sierra
Spiked Italian Montana-1 Montana-H Alabama Vermont No. Carolina
1
3,000 i;ooo
0 0 .0 0 500
'
`2,000 0 0 0 0 0 0
Fails Passes Passes Passes Passes Passes Passes
' Richard E. Stevens of Ernest F. Fullara, Inc. for Whittaker-C4D
Italian Montana-1 Montana-11 Alabama Vermont No. Carolina
.
8,250 18,000 29,250 21,825
3,225 20,850
1,350 450
5,200 6,075 `
675 6,000
Fails chrysotile & tremolite Fails chrysotile 4 tremolite Fails chrysotile 4 tremolite Fails chrysotile 4 tremolite Fails chrysotile 4 tremolite Fails chrysotile 4 tremolite
Spiked sample vas not run.
Goodhue WCD 000229
-4~
Sample
No. of Fibers
No. of Fibers ' Status With
With R.I, Greater With R.I. Less . Regard to Pro
Than 1590
" Than 1574 - posed FDA'Method
Mrs. Lucy McCrone of McCrone Associates for Kolmar
Italian Montana-I Montana-il
Alabama Vermont *No. Carolina Spiked Sample
. 53 0
0 0 0 0 488
0 0 0 0 0 0 16
, Passes Passes Passes Passes Passes Passes Passes
0
Sample noted to contain some fiber bundles which are rolled up talc plus some non-fibtous tremolite
The following participants examined their samples but were unable conscientiously to count particles with confidence, therefore, did not report numbers:
Miss Marie Jones for Dr. G. Cohen - Bristol-Myers Products Research Labs. Mr. Salvatore MBianca - The Mennen Company Liberty. Mutual Insurance Co,, Research Center - for Kolmar Laboratories Mr. John Facq - The Colgate Palmolive Company, Research Center
It was agreed that the strong inconsistencies among the data obtained by different scientists using the same method on duplicated sets of samples, clearly show that the optical microscopic method proposed in the Federal Register, vol. 38 (No. 188), p, 27076, September 28, 1973, requires either modification or replacement of a more dependable method.
Among the criticisms offered were:
1. Talc plates standing on edge are easily misidentifled as fibers', since one of the two indices of refraction will vary between 1.539 and 1.550.
2. The determination of relative refractive index becomes unreliable when
applied to extremely small (1 pm in width) particles, since at this
dimension we approach the limit of resolution and applying the Beeke
line technique becomes extremely difficult.
'
3. Chlorite, which has -a refractive index range of 1.57 to 1.66, will be incorectly identified as tremolite, in many instances,
4. The use of a one milligram sample provides a field which is too dense for good petrographic study.
5. The implication that all fibrous particles in talc, having optical properties similar to those of asbestos, are indeed asbestos is very
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n5r
probably an unwarranted assumption.
6. The number of petrographic experts with sufficient depth and training in. the use of the optical microscope, is very small, .
7. The amount of time required for one analysis ranges from 2 to 5 hours, and a borderline sample would likely to be considerably longer.
It was agreed to urge FDA to defer finalizing the proposed optical microscopic method until it can be altered to be more reliable, or even replaced if necessary. We hope that a cooperative effort between FDA and ourselves can be launched as soon as possible toward this goal.
Dr, Costello suggested that we set up a task force to develop alternative methods, and 11 agreed. The following scientists volunteered to serve as members:
Dr, Tryggve Baak Mr. John Facq Mr. David Hamer Dr. F. Robert Rolle
Dr. John Schelz Dr. Joseph Simko Mr. Howard Stanley
Dr. Rolle agreed to serve as head of the task force.
The question was raised whether we would be able to encourage a non industry scientist (or scientists) to serve on the task force. It was agreed that this is a good idea, however, there may be some financial considerations involved. Mr. Sandland will explore the availability of funds from CTFA if required.
Mr. Sandland will also draft an expanded version of Dr. Rolle's summary of data from the "round robin", along with our recommendations for presentation to the Food and Drug Administration. A copy of the draft will be sent to the membership of the CTFA Talc Subcommittee and Scientific Advisory Committee for review.
Addendum; The expanded, complete report was drafted By Mr. Sandland and submitted to the Talc Subcommittee and the Scientific Advisory Committee on December 10, 3973. After receiving comments and approval from members of both committees, the report was sent to Dr. Estrin. Dr. Estrin cleared the Subcommittee Report through the CTFA Oovemment Relations Committee on Wednesday, December 19, 1973 and indicated that it will be sent with a covering letter to FDA on Friday, December 21, 1973.
Respectfully submitted to the Scientific Advisory Committee,
GWS/lmv
George W. Sandland, Chairman
Goodhue WCD 000231