Document 5kxJL8gNmp0XyE7a1d42njeZJ

leRSSiTPJL^IW/SIR^ FRDBUCT1 A D I V I S I O N OP ^F I S T L - M Y' E R S C O M P A N Y 2 2 5 LONG AVENUS HILLSIDE, NEW JERSEY 0 7 2 0 7 TELEPHONE 2D1-B23-SOOO December 14, 1973 Dr. N. Estrinj \ Cosmetic, Toiletry & Fragrance Association 1625 Eye Street, N.W. Washington, D.C. 20006 Dear Norman: ' PLAINTIFFS EXHIBIT WCD-383 Enclosed herewith is the final draft of the CTFA Talc Subcommittee which we have prepared for submission to the Food & Drug Administration. It includes a description of the work performed by experts in evaluating samples of talc for chrysotile and tremolite using the F&DA microscopic method proposed in the Federal Register of September 28, 1973, and our interpretation of the resulting .data. It also recommends- a considerable modification of the optical method of. the development of a completely new method, and all of this to be accomplished in a cooperative, endeavor by' the F&DA and a task force which has been set up within our subcommittee, This report is now ready, in our opinion, for presentation to the Food and Drug Administration after Legal and Staff clearance at CU'A. We recommend that you provide a covering letter to be submitted with this report to the Food and Drug Administration. Very truly yours, /7 > . C s^C < I- L L L '-'--'f *: George W.Xandland , Chairman/CTFA Talc Subcommittee G W S :dd c: Talc Subcommittee Scientific Advisory Committee Enclosure . Goodhue WCD 000114 y- y -REPORT OF CTEA TALC SUBCOMMITTEE ON METHOD TO DETECT CHRYSOTILE AND TREMOLITE IN TALC. December 10, 1973 The Scientific Advisory Committee of the Cosmetic, Toiletry & EragranceiAssociation, 1625 Eye Street, N.W, , Washington, D.C. 20006 at a meeting held on September 2, 1973, designated that a subcommittee be set-up Ito study the optical microscopic method proposed by the Pood and Drug Administration. This method was published in the Eederal Register f September 28, 1973. The present membership of the CTEA Tale Subcommittee is shown-on an attached sheet; . At the first meeting of the Subcommittee, it was agreed to submit several samples of talc to members who volunteered to apply the EDA proposed optical microscopic method'. The following talc samples were distributed without identification - except for randomly applied and non-duplicated code numbers: Italian Talc Montana Talc Montana Talc Vermont Talc Alabama Talc . No. Carolina Talc Source I Source II In addition, a sample of Italian Talc spited w/w with 1% chrysotile and 0.15% tremolite was sent to each participant. The participants were aware that the sample was spiked, but did not know the percentage of spiking. The attached table summarizes all reports submitted: Final Report Goodhue WCD 000115 -2- Sample No. of Fibers No. of Fibers With R. I . Greater With R.I. Less Than 1590 . Than 1574 Status With Regard to Pro posed FDA Method - M r s . Lucy McCrone, McCrone Associates for .Chesebrougb Spiked Italian Montana- I Alabama Vermont No.Carolina Montana- II 320 120 0 0 0 0 .0 16 Passes 0 Passes 0 Passes 0 Easses 0 Passes 0 Passes 0 Passes Mr. Harold Stanley of Pfizer Italian Montana- r Montana- II Alabama Vermont No. Carolina Spiked r w 100 100 r^lOO 100 rv- 100 <1000 >100 >100 >100 >100 >100 >100 >100 Mr. David Hamer of Johnson & Johnson Italian Montana- I Montana- II Alabama Vermont No. Carolina 0 1 25 0 0 0 0 0 0 0 0 0 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 Passes Passes Passes Passes Passes Passes Spiked Italian Dr. John A. Reffner (D. of Conn.), for Avon . 632 12,930 220 1,114 Fails Chrysotile Passes Tremolite Fails Chrysotile Passes Tremolite Goodhue WCD 000116 -3- Sample No. of Fibers No. of Fibers With R.I.- Greater With R.I. Less Than 1590 Than 1574 Status With Regard to Pro posed FDA Method Dr. John A. Refiner (U. of Conn.) for Avon Cont'd Montana-1 Montana-- th Alabama Vermont 4 No. Carolina 0 5,844 Fails chrysotile Passes tremolite 13 9,281 Fails chrysotile Passes tremolite 26 15,125 Fails chrysotile Passes tremolite 41 165 Falls chrysotile ' Passes tremolite 14 11,852 Fails "chrysotile Passes tremolite Dr. Tryeeve Baak of United Sierra Spiked Italian Montana-I Montana-n Alabama Vermont No. Carolina 3,000 1,000 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. Fullam, Inc, for Whittaker-CAD Italian Montana-1 Montana-^ Alab ma 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 Sc tremolite Fails chrysotile Sc tremolite Falls chrysotile & tremolite Fails chrysotile & tremolite Fails chrysotile & tremolite Fails chrysotile Sc tremolite Spiked sample was not run. Goodhue WCD 000117 -4- Sample No. of Fibers With R.I. Greater Than 1590______ No. of Fibers With R.I. Less Than 1574 - S.tatus With Regard to-Proposed FDA'Method Mrs, Lucy McCrone of McCrone -Associates for Kolmar Italian 53 0 Passes Montana-I 0 0 Passes Montana-H 0 0 Passes Alabama 0 0 Passes Vermont 0 0 Passes *No. Carolina 0 0 Passes Spiked Sample 488 16 Passes *Sample noted to contain some fiber bundles which are rolled up talc plus some non-fihrous 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 DiBianca' - The Mennen Company Liberty Mutual Insurance Co., Research Center - for Kolmar Laboratories Mr. John Facq - The Colgate Palmolive Company, Research Center The table reveals strong inconsistency between results obtained by the different scientists applying the method tc the same group of-coded talc samples. This inconsistency is the result of problems encountered in the methodologv, 1. The alpha refractive index of talc - one of the two indices exhibited by talc plates standing on edge - varies in-value between ,1.539 and 1.550-*-. This in combination with item 2, below, miy easily result in the mis-classification of such plates aj "fibrous, less than 1,574" and therefore chrysotile. Dr. Refiner of the University of Connecticut, in his report to Avon, admits that this factor is paramount - "counts for chrysotile are high since (talc) edges will often be mistaken for fibrous particles". 2, The immersion method for the determination of'relative refractive index hexanes unreliable when applied to extremely small (ca. 1 pm)parcicles. This is due in part to the fact that particles around 1 P in width approach the limit of resolution of the human eye when both size and contrast are considered, especially when applying the Becke line technique prescribed. This will _ Goodhue WCD 000118 -5- 2. cause eye fatigue-and resulting errors. Thus, a fine talc shard or plate on edge may he easily mistaken 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 commonly found in pharmaceutical grade talc - would be incorrectly identified as tremolite. Refractive indices for chlorite vary in thejrange 1.57-1.66^. 4. The examination of a sample of one milligram1dispersed on a single microscope slide presents the investigator with a preparation which is too dense for a petrographic study. 5, The method is laborious and time consuming. Dr, Refiner quotes an analysis time of about five hours per sample and at JOHNSON & JOHNSON the investigator (D. H, Hamer), estimated at least two or three hours. - 6, Dr. Walter C. MeCrone in an earlier letter to the FDA suggested that there were relatively few scientists in the country who could 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. Thie 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 assumption. REFERENCES: 1, Deer, W.A., Howie, R.A., and Zussman, J, , Rock-Forming Minerals, Vol. 3, p. 121 (1962). 2, ibid, p. 131. ***************** We have concluded that the method published in the Federal Register does not provide a truly reliable means for the detection of asbestos in talc. It results in both false-positive and false-negative findings. It is also tedious and may consume as much as one half day per sample. The subcommittee urges that the Food and Drug Administration defer finalizing the proposed optical microscopic method and proceed into a Phase II program which would combine FDA and Industry in a strong effort to develop a truly reliable method for measuring chrysotile content in talc. We are confident that the detection and estimation of fibrous tremolite can also be done, If necessary, as a fringe benefit, at the same time, Goodhue WCD 000119 -6- We estimate that a satisfactory method will take at least six months to a year, to develop. We suggest a close liaison between FDA and industry in this all-out effort with updating reviews to take place as frequently as necessary. Review of Alternate Methods The CTFA Talc Subcommittee has reviewed several methods to detect chrysotlle and trjemolite in talc, Including modifications of the optical microscopic method. These are listed with comments.' '' 1- . Optical Microscopic Method - may be used.with some modification. Possibly better selection of R.I. liquids and redaction of sample size per slide. 2. X-ray Step Scanning - A good method for detecting tremolite if we could accept about 0.2% as the threshold of detection. It does not distinguish fibrous from non-fibrous tremolite. The simultaneous detection of chlorite makes method impractical for chrysotile, 3. X-Ray Step Scanning + Optical Microscopy - Acceptable as in #2 above but the optical method continues to present the dilemma in reliable identification of chrysotile. However, this does not rule out a major revision of the optical method to do the chrysotile identification! and counting. 4. X-Ray Scanning - The problem 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. Differential Thermal Analysis - This procedure is capable of detecting chrysotile at the 1% level, however, it will not detect tremolite. 6. Scanning Election Microscopy - This procedure is not capable of identi fying asbestos. Even with energy dispersive analysis, completely satisfactory identification is not possible. 7. Transmission Electron Microscopy + Electrcn Diffraction - This appears to offer the best, most reliable method 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 prohibitive for the small manufacturer who uses talc. The amount of talc sample examined by this procedure is miniscule, Goodhue WCD 000120 " 7- Smmnary . The CTFA Talc Subcommittee has completed its review of the Optical Microscopic Method for the Estimation of Chrysotile and Fibrous Tremolite in Talc, which appeared in the Federal Register, vol. 38 (No. 188),(p. 27076, September 28, 1973). It recommends postponement of the finalisation of the proposed regulation oh talc. In addition, a collaborative effort between FDA & industry toresolve a satisfactory method of estimating chryscjtile and tremolite in talc, is recommenjjed, with periodic liaison reviews to monitor the project status. A task force of industry experts has be!en designated to pursue alternate methods. We, invite FDA to participate in collaboration with the task force. George''W. Sandland Chairman CTFA Talc Subcommittee G W S :dd Goodhue WCD 000121