Document 2J81Nq8NeKdp3DvMjLxJjgXkR

Jack Travers reported that NioSH has proposed a revised (lower) TLV of 50 meg/cubic meter for crystalline silica. Bob Rolle described the latest results of Round Robin #3 using the CTFA Proposed Optical Microscope Procedure For Detection of Chrysotile in Talc. This is the method intended to be used as a back-up to the.DTA method, since DTA can give a false positive for chrysotile when non fibrons 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 ef.il" awaiting additional DTA results on tale samples (some spiked) which were sent to Colgate-Palmolive, Mennen, Pfizer, and Whittaker Clark & Daniels. In addition, Jack Travers has submitted a set of samples to John Refiner (V. of Comm) for DTA analysis. Jack Schelz described an inexpensive DTA unit sold byColumbia 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 0.5% 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 asbestiform or fibrous the following criteria will be used by the Salt Lake City Laboratory of OSHA, AAAKBPXLD CF-BALL-6 PLAINTIFFS EXHIBIT CAM-164 2- - A. Particles must appear to be fibrous, rather than as crystals or slivers. B. The maximum diameter of a fiber to be counted is 3 microns. C. The maximum length of a fiber to be counted is 30 microns. B. The length to width ratio must be 5 or more to 1, that is, S 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-divislble 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 CTFA Talc Task Force c- ^.o:.ed of l':c , Berdiek, Br, Kstrln (CTFA), Mr, Lee, Br. Rolle and Mr. Sandland will meet with B r . Robert Schaffner, Mri Eiermann and their designated personnel at FDA on Triday, February 7, 1975. It is planned to propose the 0.5 to 1.0% 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 is 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 3- - developing 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 submieroscopie 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-abdominally. There being no further business, the meeting was adjourned. W. Sandland Chairman, CTFA Talc Subcommittee