Document on6V3oEXvrKQQ2dpVevkkeZ8

FILE NAME: Johnson & Johnson (JAJ) DATE: 1977-1978 DOC#: JAJ087 DOCUMENT DESCRIPTION: Internal Report - Special Talc Study, Dec 1977 - Jan 1978 BABY PRODUCTS COMPANY RARITAN, N.J. 08869 Special Talc Study Project No. 0503.01 Report for December 1977 - January 1978 OBJECTIVE: To monitor and defend against consumerist, scientific and regulatory attitudes/trends which could impact adversely on the safety image and marketability of cosmetic talcs. To generate or provide necessary data to support and reinforce the safety of our baby powder. SUMMARY: A. Lovelace/FDA Tale Exposure Study Two talc samples used in the Lovelace animal exposure study were submitted by W. Waggoner for characterization in this laboratory. 1. WC & D talc 141 Lot 12-21-22 (January 1976) 2. A classified fine fraction of (1) which was actually used in the study. Our examination revealed these talcs to be finely divided, relatively pure platy talcs. Talc (2) is obviously of finer particle size than talc (1). No asbestos minerals were detected by x-ray diffraction or microscopic examination. Automatic size analysis was run by an outside consultant (EMV); results were as follows: Results of Size Analysis Mean of the Mean of Aspect Mean of Maximum ^ Average Diameters ym Ratio Min/Max Diameters pm "unseparated talc" 2.75 0.47 3.97 (2) "classified talc" 1.17 0.38 1.78 Detail findings were reported to W. Waggoner for his discussion with Lovelace. 729 TO Protected Document-Subject to Protective Order 1 of 3 JN J 000231766 Pltf_JNJ_00028745 -2 - Project No. 0503.01 Report for December 1977 - January 1978 B. Model FAM Fibrous Aerosol Monitor GCA Corporation - Bedford, Mass. A visit was made to the Precision Scientific Group of GCA. The operation of a new instrument, the Fibrous Aerosol Monitor, was demonstrated on samples of talc and JBP which we supplied. This instrument detects and counts airborne fibers in the presence of high concentrations of non-fibrous particles. In our test the instrument was preset to detect fibers 3 pm or longer and an aspect ratio of 3:1 or greater. Other threshold limits can be set. The minimum detectable fiber diameter is 0.2 pm. The following tests were run and results obtained: Sample V-66 Talc Fiber Concentration Fibers/cc Entire Powder Respirable Fraction 0.28 No Test JBP 0.08 0 V-66 talc + 3% wt. Tremolite 0.40 0.24 These results indicate our talc and product are well below the current 2 fibers/cc permitted for asbestos. A good deal of interest has been generated by this device in both industry and government agencies, including NIOSH, who is currently testing a prototype. This instrument will greatly reduce the time required to determine airborne fiber concentrations which presently require a tedious microscopic recognition and counting technique. C. Weekly Talc Examination for Asbestos This is to remind everyone that weekly composite samples of Windsor 66 talc production are routinely examined for freedom from asbestos minerals and quartz. This testing program, which involves Differential Thermal Analysis and Slow Scanning X-Ray diffraction, has continued uninterrupted since March 1972. No asbestos minerals have been detected in this time period. Protected Document-Subject to Protective Order 2 of 3 JNJ 000231767 Pltf JNJ 00028745 -3 - Project No. 0503.01 Report for December 1977 - January 1978 D. Talc Criteria Document (NIOSH) A review of all J&J data on talc exposure was completed and collated. Dust levels were determined under operating conditions at ESDP using the Mass Monitor under supervision of BPC research; results show a remarkably low respirable dust level; similar tests are planned at SSDP. A decision was reached to submit a response to a recent NIOSH call for information on talc which is a first step in the preparation of a criteria document to be ultimately issued by that Federal Agency. Baby Products Company Research has begun to prepare the response aimed at establishing the safety and absence of hazards related to high grade (cosmetic) talc exposures. Prepared by: R. S. Russell & W. H. Ashton Protected Document-Subject to Protective Order 3 of 3 JNJ 000231768 Pltf JNJ 00028745 C on fid entiality C ustodian D ocum entType Y Legacy 1 Physical JNJ000231766 Metadata O R IG IN A L O R IG IN A L O R IG IN A L