Document bO5Xm3MrEzRGExDO1E9q0pgmD

FILE NAME: Johnson & Johnson (JAJ) DATE: 1973 M ay DOC#: JAJ204 DOCUM ENT DESCRIPTION: Proposed Specs for Analyzing Talc for Asbestos Subject: (jjtmxmdjjt'wwm p I New Brunswick, N.J. M a y 16, 1973 Dr. F. R . Rolle I am going to England Friday, May 25. I have been asked to bring along our proposed specs for analyzing talc for "asbestos." P le a s e get me copies of all reports, correspondence, e t c ., that are pertinent, plus a cover m em o outlining our recom m endations. England is considering method of preconcentrating the asb estos so as to be able to analyze by X -r a y . They find no " asb estos" by doing this with Italian talc.. They find (Pooley) 0.05% of a trem olite-type in Vermont. mf c: Dr. R. A. F u ller Dr. A. J. Goudie D r . W. N a s h e d Dr. D. R. Petterson T. H. S h e lle y ' Protected Document-Subject to Protective Order JNJNL61 000008180 I / > S u b je c t: ,/ PROPOSED SPECS FOR ANALYZING i / TALC FOR ASBESTOS N e w Brunswick, N. J. May 22, 1973 Dr. T. H. Shelley > I. USP ' 'u II. Other Methods Step Scanning X-Ray Diffractometry Advantages Disadvantages Preconcentration of Asbestos (Pooley Method) Differential Thermal Analysis Microscopy Electron Microscopy and Petrology Dispersion Staining III. Present Strategy / F. Robert Rolle, Ph.D. ab cc: Dr. A. J. Gouc Dr. G. HildickVSmith Dr. W. Nashed \J Dr. D. R. Petterson received: MM 2373 Protected Document-Subject to Protective Order JNJNL61 000008181 1 USP 1 ' . - We have been working on a preliminary draft with Mr. George : Heinze on developing a USP method for the detection.of asbestos in talc. Exhibit A is the USP XIX comment proof 1 on X-ray diffraction. Exhibit B is our detailed procedure which has been submitted to Mr. Heinze, for determination of. amphiboie (such as, tremolite) and serpentine (such as, chrysotile) in talc by scanning X-ray diffractometry. ulsing this method on Italian Talc used in SHOWER TO SHOWER* powder, we find a level of detectability of .1% for Tremolite I and 5% Chrysotile. . l ' ' . ' o ' II. Other Methods Which Have Been or Are Under Consideration for the Detection of Asbestos in Talc Step Scanning X-Ray Diffractometry Advantages: Level of detectability better than by scanning X-ray diffraction. For example, by this method we can detect 0.1% tremolite and 3% chrysotile in Italian talc (Exhibit C ) . Disadvantage: Using the step scanning procedure, it takes one day per sample for analysis vs. a small fraction of a day for the scanning method. *A Trademark of JOHNSON & JOHNSON. Protected Document-Subject to Protective Order JNJNL61 000008182 - 2- Preconcentration of Asbestos followed by X-Ray Diffraction Analysis (Pooley Method) '!! ' Dr. Pooley has developed two techniques for preconcen- I' . tration of chrysotile and tremolite in talc followed by I . ' X - r a y diffraction analysis. For chrysotile (Exhibit D ) , !| his level of detectability is 0.05% and when this method is. applied to Italian and Vermont talc, no chrysotile is detected. The second technique developed also by Dr. / ' ' pooley involves preconcentration of tremolite in talc (different procedure) followed by X-ray diffraction analysis, This technique has not been written up yet, but evidently when applied to Vermont talc, 0.05% of tremolite-type is found. The limitation of this method is that it may be too sensitive. Differential Thermal Analysis.(DTA) DTA has proven to be a relatively fast and sensitive method (at least 1%) for detection of chrysotile in talc (Exhibit C ) . The DTA method is not applicable for the detection of tremolite in talc. At our suggestion, the FDA recently purchased a DTA unit, presumably to look into this method for detecting chrysotile. Protected Document-Subject to Protective Order JNJNL61 000008183 Microscopy it A. Electron Microscopy and Petrology The areas of electron microscopy and optical microscopy (petrology) have been thoroughly evaluated, but though, i not without merit, they suffer from the following a) require a fair degree of expertise b) in the case of electron microscopy, we are dealing with an expensive instrument that few laboratories have. c) one is viewing a very small amount of material (ig) under the microscopy and one wonders how representa tive it is of the bulk material. Multiply sampling and viewing under the microscopy may eliminate this problem, but it results in consumation of a great deal of time. d) the level of detection really depends upon the amount of time spent with the microscope. e) quantification by particle counting is very time consuming and normally not done. B. Dispersion Staining The dispersion staining method championed by Dr. Walter , McCrone looked initially very exciting as a quick, easy method for scanning talc for asbestos. .However, it was found (Exhibit E) that certain non-asbestos minerals gave the same dispersion staining characteristics as the asbestos minerals. The method evidently lacks, specificity when applied to talc. Protected Document-Subject to Protective Order JNJNL61 000008184 4 III1. Present Strategy I Present plans call for scanning X-ray diffraction for the detection of both amphibole and serpentine asbestos in : talc. In the case of chrysotile (serpentine), Differ ential Thermal Analysis may be a good alternate method since it offers a. level of detectability of 1% chrysotile in talc vs. 5% chrysotile in talc by scanning X-ray dii ffraction. Protected Document-Subject to Protective Order JNJNL61 000008185