Document jmanJ1jdgL7jQ0M26rYNkMjvQ

\ Between: Subject: MEMORANDUM OF MEETIKG July'~S/i 971 Representatives of Johnson & Johnson Research Division, New Brunswick, N.J. and The Food and Drug Administration Asbestos Particles in Talc \ The meeting was held in Dr. Schaffner's office in FB-8, 200 "C" Street^ ~SW.r-Washington, D,C. - Dr. hashed of Johnson & Johnson opened the meeting by briefly reveiwing the recent events on the subject of asbestos particles in talc. He in dicated that the group present at the meeting from Johnson A Johnson*I& would like to review the analytical .vafehodalogy on the detection and 'determination of asbestos particles in talc. He indicated they would be I happy to answer any questions we had concerning methodology. Dr. Shelly indicated that talc used in Johnson's Baby Powder was Vermont talc obtained from their own mines. The mined talc is purified by flot ation. This talc is incorporated into baby powder which has the follcwin composition: Talc Calcium Carbonate (a constituentof talc) Sodium Citrate 0.27o ( a buffer) Per fume 0.2% & Dr. Rolie showed photographs of talc obtained by use of an electron micro jr Pagi <"1 scope at 50Ox magnification. In these photographs, compari sons were made between Vermont talc used in Johnson5s products and samples of talc containing 1, 5, 25 and 50% asbestos particles.. It was their opinion that these photographs leaded additional evidence that their talc contains less than 1%, if any, asbestos. Dr. Rolle was quick to point out that this technique was not very reliable analytically. Dr Hashed provided Dr. Schaffner with three (3) copies of a report on the analyses of Johnson's Baby Powder and various samples of Vermont talc used in Johnson's Baby Powder. This report contained the following 3 parts. 1. June 24, 1971, Report on Particle Siae and Shape Distributions of Grantham, Italian, and Vermont Talc Final Products for Johnson & Johnson by*23 Colorado School" of H i nes Research Institute.------------------ 2. July 7, 1971, X-ray analyses report on JOHNSON'S Baby Powder sample 344-L, and six samples of Vermont Talc by Colorado School of Mines Research Institute. 3. June 28, 1971, Report of x-ray examination of Talc Products by Dr. R. C, Reynolds, Jr., Geology Dept., Dartmouth College, Hanover, New Hampshire. Dr. Hashed noted that the information and data submitted contains trade, secrets and is confidential and that FDA may not make it public without written permission from the company. Dr. Cane at: then briefly discussed the contents of the reports submitted and described the various analytical techniques usad to obtain the re results. ported. The techniques used were microscopic exam ins,tion (point counts Page 3 were made at 500x) and X-ray diffraction* Dr. Caneer indicated that he would send the details of the procedures used to Dr. Schaffner in the near future. Dr. Caneer then described the results from X-ray diffraction examination of Vermont talc* These results indicated that this talc contains essen tially no anthcphyllita and only minor amounts (below 1%) of tremollte and actinolite, or in other words contains less than 1%, if any, asbestos particles. Dr. Caneer was confident that X-ray diffraction would detect most mineral forms of asbestos at a level of 1%. Dr. Shelly indicated that within the next few weeks Johnson and Johnson will have analyses of Vermont talc from an additional 3 or 4 independent laboratories. Dr. Smith then reviewed some of the medical reports in the literature about asbestos. He indicated that the presence of asbestos to the ex tent of 5% by weight gave rise to medical problems in industrial workers. He then outlined the type of future testing that would be carried out by Johnson and Johnson. Those attending from industry were: R.F. Rolle, Ph.D. Laboratory Supervisor Johnson & Johnson Research Division New Brunswick, N.J. 08903 Wilson Hashed, Ph.D. Division of Science Information JJ T. H. Shelley, Ph.D. s' Director, Research Dept. TT G. H. Smith, H.D. Director of Clinical Research JJ W ( T. Caneer Asst. Manger, Mining Division (Consultant for J. and J.) Colorado School of Mines Research Institute Golden, Colorado 80401 Page 4 From FDA*. R c N. Schaffner, Ph.D. Director Office of Technology Cc J. Kokoski, Ph.D. Division of Toxicology H. R. Gittes Division of Toxicology S. H. Kewburger, Ph.D. J. Ac Wenninger Division of Colors & Cosmetics Technology Division of Colors 6c Cosmetics Technology W. V, Eisenberg Division of Microbiology R. E. Newberry Division Case Guidance 7/1Q Lx77l1Jrj,r7A John A. Wenninger <r 7 .Assistant Chief, Cosmetics Branch /Division of Colors a Cosmetics &