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Johnson BABY PRODUCTS COMPANY - RARITAN N.J. 08869 April 28 1977 SUBJECT TO Status Report - Defense of Talc Safety Mr. D. D. Johnston Since our represent last report of February 7 1977 the follow new status in the talc safety program I. & Talc Data Generation .1 Battelle's exploratory work is still in progress for evaluating the interaction of talc with lung macrophage They are evaluating whether their vitro model can provide response data 2 The CTFA round robin analysis of seven major powder brands has indicated some discrepancies with several laboratories in their application of the methodology -Operator to be the problem and it will the CTFA Task Force inexperience be addressed appears by II FDA Panel ~ Talc Reviews 1. Misc External OTC Drug Products Panel This panel has reviewed tale and placed it in Category I Safe & Effective The Panel stated that Talc free from asbestos fibers is safe and effective as a lubricant and absorbent on intact skin III We do not expect any other OTC Panels to be reviewing tale Talc Scientific Publications The following paper was published Inhalation study of talc baby powder by hamsters Webner et al - Jrnl Food & Cosmetics Tox No. 2 Vol 15 p.121 April 1977 729 10 JNJ 000251368 Status Report MA Defense of Talc Safety D. D. Johnston The following cation in the papers have been submitted for publiJournal of Food & Cosmetics Toxicology Pulmonary deposition translocation and clearance of inhaled activated talc in hamsters Wehner et al Leaching of radio nuclides from activated talc in serum and dilute HCL Wehner et al Gastro intestinal absorption of tale in the Syrian Golden hamster Wehner et al IV Non & Talc Studies 1 Lovelace Foundation This laboratory reported that their animal study showed no treatment pathology had been observed after 6 months inhalation exposure to aerosolized talc 2. NIOSH Vermont Talc Workers Morbidity and Mortality An expert consultant has confirmed that there is strong basis for questioning the validity of their mortality study and their preliminary conclusions The final report has not been made available to us The NIOSH survey of current occupational environment has confirmed the absence of asbestos and negligible quartz Their environmental study report will be presented May 26th at the conference of the American Industrial Hygiene Association The morbidity data is still being analyzebdy Harvard V. BPC Product Strategy 1 Additional product tests are being conducted with aged treated JBP to reduce the respirable concentration 2 Single mold samples of new shaker tops were reviewed and the living hinge cap was selected for advanced prototype fabrication Fall product testing is anticipated i . j , f by cc Distribution George Lee \ i 3| \ JNJ 000251369 DISTRIBUTION TO D. D. Johnston CC B. D. R. E R. B. J. J. S. R. H. C. P. M. Deavenport R. Petterson C. C. Stites West S. Fine Semple R. Runnells R. Marshall P. Falk N. Miller Kramer La Rosa Lonergan JNJ 000251370