Document 2qJmmaLor40O5gyRvVLaLv2O7

The 'Cosmetic, Toiietry and Fragrance Association, ine. 1625 EVE STREET, N.W., WASHINGTON, D. C. 2QDC6 202/393-2070 James H. Merrilt Pre tid ont Norman F. Estrin, Ph.O. Wc# Pttident--Sc/ertc* October U f 1973 MINUTES CITA SUBCOMMITTEE OF SAC N ASBESTOS IN TALC The .first meeting of the CTFA Subcommittee of the Scientific Advisory Committee, on Asbestos in Talc, was held on October 4, 1973 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. Salvatore Di Bianca, The Mermen Company Mr. John Pacq, Colgate-Palmolive Company Dr. David Hamer, Johnson fit Johnson Mr. Ray R. Kratnmer, Whittaker, Clark and Daniels Dr. Dewitt Petterson, Johnson & Johnson Dr. Robert Rolle, Johnson fi Johnson Mr. Fred Roesch, Whittaker, Clark and 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 asbestos 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 experts including Walter McCrone agree that there are probably a total of 20 microscopists in the United States who would be sufficiently ' qualified to do the analysis. ' ^ uEXnHtIBfITf s WCD000078 -2 CIFA SUBCOMMITTEE OF SAC ON ASBESTOS IN TALC It was generally agreed that with some modification the methodology could he 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 ^ore over for several hours, then KbaO sc de dr i /or nn the vn-vao ture no4*f >4t.I*hJ i--s --m~Tiniscul'I eA samp..l^ e, make, a_ j udt gme. 1nt. on a 2i . 0 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 from 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 with a description by Joseph'Simko of the method which was developed at Colgate,^ In contrast to optical microscopy, the X--ray'method has a lower limit'of detection of 0.5%. It is considerably more reliable for discriminating chrysotile and tremolite and uses a 500 milligram sample, thus providing much 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 talc from several sources-in the United States and including Italian talc. Bob Rolle, agreed to furnish a set of samples which will be "seeded" with tremolite and chrysotile using a special technique to assure homogen eity. These are intended to assist in optical recognition and 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 scanning-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, Whittaker, Clark and Daniels Dr. John.Travers, Avon Products, Inc. Mr, Ronald Yakupcin, Kolmar Laboratories, Inc. . ' ' **' ' George Sandland will prepare, code and distribute the samples to the above list of persons. " It was also agreed that George Cohn will contact Pfizer to encourage participation to. the work of the Committee, WCD000079 ! -3 - CIFA SUBCOMMITTEE OF SAC OK ASBESTOS IN TALC The Committee wishes to approach the evaluation of the FDA proposed I 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. f* j I Following th 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 Advisory Committee, ' lr *J h . '* George *?>'Sandland, Chairman *-`V(' f GWS:dd cc: P. Reisberg - Carter Products WCD000080