Document bBd9X6m8ky9jZO8qqgq6KB6gy

Meeting Date: February 4, 1975 Release Date: February 26, 1975 MEETING NOTES OF CTFA TALC SUBCOMMITTEE PRESENT: Mr. George Sandland, Chairman Mr. Salvatore DlBianca Dr. George Cohen Dr. Allan Harvey Mr. George Lee Dr. F, Robert Rolle Dr. John Schelz Mr. Joseoh Simko Dr. John Travers Bristol-Myers Products Mennen Co. Bristol-Myers Products R, T. Vanderbilt Johnson 4 Johnson Johnson & Johnson Johnson & Johnson Colgate-Palmolive Avon Products COPY; Dr. Murray B e r c k Dr. Christopher Costello Mr. Ray Kr anises Mr. Fred Roesch Mr. Harold Stanley, Jr. Dr. C. S. Thompson Mr. Ronald Yakupcin Che3ebrough-Ponds Colgate-Palmolive Whittaker, Clark & Daniels Whittaker, Clark & Daniels Pfizer R. T. Vanderbilt Kolmar Laboratories CC: Mergers of Standard Committee Ms. Anita Curry Dr. Norman Estrin Dr. John Menkart Mr. Eugene Lambert The meeting was held In the Technical Services Conference Rocm at Bristol--Myers Products, 225 Long Avenue, Hillside, N, J EXHIBIT WCD-227 WCD000067 Jack Travers reported that NlOSH has proposed a revised (lower) TLV of 50 mcg/cubic mater for crystalline silica. i|i j Bob Rolle described the latest results of Round Robin #3 using the CTFA Proposed Optical Microscope Procedure For Detection of Chrysotile in Talc. Tf^ie is the nethod intended to be used as' a back-up to the DIA method, since DTA can give a false positive for chrysotile when non fibrous antigorite Is present. Unfortunately, there was disagreement among 3 very capable investigators, McCrone Associates, Harold Stanley of Pfizer and Dave Hamer of Johnson & Johnson. It was agreed, however, that chrysotile is never found in cosmetic talcs, based on numerous analyses by several investigators. The only discoverer of chrysotile in cosmetic talcs has been Professor Lewin, and his results have been refuted in a repeat testing of the same samples by John Stuart at FDA. The committee concurred, therefore, that our only courses of action are either to rely only on DTA by itself (without a back-up procedure), or else, baaed on the wealth of data available, eliminate' the need for a chrysotile specification in cosmetic talc. Either way, we are confident at this point, that chrysotile won't be found and simply is not present in cosmetic talc. We are still awaiting additional DTA results on talc samples (soma spiked) which were sent to Colgate-Palmolive, Mennen, Pfizer, and Whittaker Clark & Daniels. In addition, Jack Ttavers has submitted a set of samples to John Reffner (V. of Comm) for DTA analysis. Jack Schelz described an inexpensive DTA unit sold by Columbia Scientific Industries costing $3350 without a recorder and about $4600 with a recorder. This instrument was evaluated by Dr. Schelz and was found to be capable of detecting serpentine minerals above the Q.5X w/w level in talc, when used according to the proposed CTFA test method. It was agreed that we include in the procedure for chrysotile, the latest definition of a fiber as published by OSHA in Field Information Memorandum #74-92, which was sent to OSHA Assistant Regional Directors and Area Directors. This memorandum states that: "In order to be considered asbeseiform or fibrous the following criteria will be used by the Salt Lake City Laboratory of OSHA, WCD00006B - 2- A. Particles must appear to be fibrous, rather than aa crystals Ior silvers. B. The raaodnum diameter of a fiber to be counted is! 3 microns. C. The maximum length of a fiber to be counted is 30 microns. D. The length to width ratio must be 5 or more to 1, that is, 5 times or more longer than wide. E. The separate or individual fibers must contain fibrils or the "bundle of sticks" effect, unless they are at a non-dlviaible stage. A fibril cannot be subdivided and would be counted, if it meets the other criteria. The electron microscope may be used to prove the fibrous nature of the particles. The length to width ratios of 5 or more to 1 is not meant to imply that other particles are not hazardous." The directive states at the end that the above guidance is temporary and may change as a result of findings from an on-going NIOSH study on this subject. A CTPA Talc Task Force comprised of Dr. Berdick, Dr. Estrin (CTFA), Mr. Lee, Dr. Rolle and Mr. Sandland will meat with Dr. Robert Schaffner, M r i .Eiermann and their designated personnel at FDA on Friday, February 7, 1975. It is planned to propose the 0.5 to 1.0X limit for each fibrous tremolite and chrysotile in cosmetic talc. Our CTFA Task Force developed methodology will be submitted in latest form as part of the proposal. A preliminary meeting at CTFA Headquarters will be held in the morning and the meeting with FDA is scheduled at 1:00 P.M. A report of this meeting will be submitted to the members of the CTFA Talc Subcommittee. Allan Harvey reported that he will attend a meeting on Tuesday, February 11, 1975 which has been called by Dr. Raymond E. Shapiro of FDA who xb heading up a Subcommittee on Asbestos Protocols. This subcommittee was assigned the job of reviewing all existing data with respect to the biological effects of orally administered asbestos, with particular reference to carcinogenesis, and if necessary of WCD000069 - 3- appropriate protocols for studies to elaborate on any data deficiencies in this area. At the meeting of February 11th., the subcommittee members will discuss a working draft which has been furnished to them to provide a basis for comment and discussion. A paper entitled "is Short-Fibered Asbestos Dust a Biological Hazard?" by Paul Gross, M.D., Charleston, S. C. was discussed. Here Gross states there is evidence that asbestos Particles which are submicroscopic in size (<5 microns)elicit only a macrophage reaction in the lungs of monkeys. Similar results resulted in several other animals including rats and hamsters when submicroscopic asbestos was injected intratracheally and intra-ab dominally. There being no further business, the meeting was adjourned. K. W. Sandland Chairman, CTFA Talc Subcommittee WCD000070