Document 3NrBbZJ22mDNvZyk6gMKDMv2D

FILE NAME: CTFA (CTFA) DATE: 1973 Oct 11 DOC#: CTFA018 DOCUMENT DESCRIPTION: Meeting Minutes-CTFA Subcommittee of SAC on Asbestos in Talc /-re. ' f t /' e The Cosmetic, Toiletry and Fragrance Association, Inc. 1625 EVE STREET, &W ., WASHINGTON, O. C, 20QC5 2C2/393-23T0 Jame H, Mem Norman F, Eatrin, Ph.Q, Wff Pwitiefii--Setene* October 11, 1973 * H1HIES I CTFA SUBCOMMITTEE UF SAC OK ASBESTOS IN TALC The first meeting of the CTF Subcommittee of the Scientific Advisory Committee, on Asbestos in Talc, was held on October 4, 19'73 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, 3ristol-Myers Products Dr. Christopher Costello, Colgate Palmolive Company Mr. Salvatore Di Bianca, The Mennen Company Mr. Joan Facq, Colgate-Palmolive Company Dr. David Hamer, Johnson & Johnson Mr. Pay R. Kxammar, Whittaker, Clark and Daniels Dr. Dewitt Petcerson, Johnson & Johnson * Dr. Robert Frolle, Johnson & Johnson Mr. Fred Roesch, Whittaker, Clark and Daniels Dr. Joseph P. Simko, Jr.t 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 thi method guidelines. It is estimated by at least two academic sources, that the running of a single sessile would take at least six hours for a count and a tenta tive identification. The tedium effect pn the person counting is obvious. Several experts including Walter McCroae agree that there are probably a total of 20 microscopists in the United States who would be sufficiently qualified to do the analysis, WCDQ00078 -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 smell sample, one milligram in size, which| one must oxe 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 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 scantling 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*57*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 scantling* method used by Colgate. Dr. Dr. *Dr. Mr *Dr. Mr. Dr. Mr, Murray Berdick, Chesebrough Ponds George Cohen, Bristol-Myers Products Christopher Costello, Colgate-Palmolive Company Salvatore diBIanca The Mermen Company DeWitt Petterson, Johnson & Johnson Fred Roesch, Whittaker i Clark and Daniels John. Travers, Avon Products, Inc. Ronald lakupcin, Kolmar Laboratories, Ipc. 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 in the work of the Committee, WCD000079 -3 - CTFA SOTCOMMITTEE OF SAC OK ASBESTOS IN TALC The Committee wishes to approach the evaluation o the FDA proposed optical microscopic with an open mind and recommends withholding the i critical commenting in these notes until a fair evaluation through the ,rrotmd robin11!is completed, p* 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 Bri Costello and Colgate for permitting ns to nse their facilities for this meeting. Dr. Costello also offered*to accomo date us for future meetings. Respectfully submitted to the Scientific Advisory Committee* y ' George W v `Sandland, Chairman GWS ;dd cc: P. Relsberg - Carter Products WCD000080