Document reJowZ517ZozXNzg41zLKMx5r

FILE NAME: CTFA (CTFA) DATE: 1974 Sept 6 DOC#: CTFA037 DOCUMENT DESCRIPTION: Letter- Less than 1% Asbestos Safe in Talc based on TLV-Cross Referencr J&J #8 SEP 9 G. LEE mxm h ew Br u n s w ic k , n. 00903 Septem ber 6, 1974 R obert M. S ch affn er, Ph. D. A ssociate D ire c to r for Technology Bureau of Foods Food and Drug A dm inistration D epartm ent of Health, Education, and W elfare 200 "C " S tr e e t, S. W. W ashington, D. C. 20204 Dear D r. Schaffner: Johnson & Johnson has been cooperating with the C osm etic, T oiletry and F rag ran ce A ssociation Subcom m ittee on A sbestos in Talc. In an e ffo rt to answ er the question about the re q u ire d degree of sen sitiv ity of the m ethod of assay for asb esto s in talc, our statistical group has made an estim ation of a th eo retical safe level of a sb esto s fib er in a baby powder utilizing the official TLV for asb esto s and the data on dusting of baby pow der. The calculation shows th at a substantial safety factor can be expected w ith talc co n tain in g 1% w /w a s b e s to s f ib e r s . T h e re fo re , m e th o d s capable of d e te rm in in g l e s s th an \io a s b e s to s in ta lc a r e not n e c e s s a r y to a s s u r e the; s a f e ty of c o s m e tic talfi.. The r e p o r t is a tta c h e d h erew ith . Since I have been assig n ed a new function a t ou r R e se a rc h C eiiter, 1 w ill be tu rn in g o v er m y resp o n sib ility in the ta lc /a s b e s to s a re a to the R e s e a rc h D ivision of our Baby P roducts Com pany. I would a p p reciate your giving me the opportunity to p e rso n a lly p re se n t them to you and your staff to a s s u re a continuation of the cooperative e ffo rts o f J o h n s o n &: Jo h n so n in th is d iffic u lt p ro b le m . The follow ing individuals fro m our Baby P roducts Com pany will be Protected Document-Subject to Protective Order JNJNL61_000013575 D r. B.. S chaffner - 2- S eptem ber 6, 1974 av ailab le fo r a m eeting to be s e t a t your convenience: D. R. P etterson, Ph. D ., V ice-P resident, R esearch . Sem ple, M. D ., D irecto r of M edical and R egulatory A ffairs G. Lee, M anager of Applied R esearch VT. C. W aggoner, Ph. D . , A d m in istra to r of M edical and Regulatory A ffairs. . I hope to h e a r fro m you soon. Very truly yours, JOHNSON & JOHNSON w n/cw *V,\j . Ki V-*> by: W. Nashed, Ph. D. A ssociate D irector of R esearch Domestic Operating Company A ttach. bcc: D r. A. Goudie D r. G. K ildiclt-S m ith M r. G. L eo^i . M r. J. Melton D r. D. P e tte rs o n D r. R. Rolle D r. T. Shelley M r. G. M iller M r. R. M iller, "Windsor M inerals M r. W. D ean, J& J G re a t B rita in D r. B. Semple D r. W. W aggoner Protected Document-Subject to Protective Order JNJNL61 _000013576