Document Xg0dpgO7Xpmb7mxMDzEKx894

K 'f e 1 v:Wy V :\ / "1 I ./ The Cosmetic, Toiletry and Fragrance Association, Inc. V i 1133 15th STREET, N.W., WASHINGTON, D.C. 20006 202/331-1770 TELEX 83-2673 James H. Merritt , Preside M * Norman P. Estrln, Ph.D. We* P m td e n l-- Science TALC SUBCOMMITTEE MINUTES A meeting of the Talc Subcommittee was held on March 15, 1976 at CTFA Headquarters. Those in attendance were: George Sandland, Bristol-Myers (CHAIRMAN) Murray Berdick, Chesebrough-Pond's, Inc. Christopher Costello, Colgate-Palmolive George Lee, Johnson & Johnson Roderick Mundy, Sterling Drug Inc, Fred Roesch, Whittaker, Clark & Daniels Joseph Simko, Jr., Colgate-rPalmolive Terry Smith, Paberge Ian Stewart, Walter C. McCrone Associates, John Travers, Avon Products, Inc. Norman Estrin, CTFA Anita Curry, CTFA Inc. The meeting opened by critically reviewing submissions made by members of the.subcommittee. Mr. Sandland highlighted the results of the Friday meeting with the Food and Drug Administration. Mr. Lee also summarized his letter describing Dr. Pooley's results. The meeting adjourned to reconvene at FDA. The Talc Subcommittee reconvened at FDA on March 15,. at 1:00 p.m. Those in attendance from industry were: George Sandland, Bristol-Myers Murray Berdick, Chesebrough-Pond's Christopher Costello, Colgate-Palmolive George Lee, Johnson & Johnson Roderick Mundy, Sterling Drug Inc. Fred Roesch, Whittaker, Clark & Daniels PLAINTIFFS EXHIBIT WCD-420 Goodhue WCD 000251 2 Joseph Siiriko, Jr., Colgate-Palmolive Terry Smith, Paberge Ian Stewart, Walter C. McCrone Associates, Inc. John Travers, Avon Products, Inc. Norman Estrin, CTFA Those in attendance from FDA were: Henry Davis Heinz Eiermann Martin Greif Robert Schaffner John Wenninger Ronald Yates The meeting opened with a brief description of the purpose of the meeting. A letter ana attachments prepared by cosmetic manufacturers and suppliers wore submitted to FDA. Chairman Sandland asked each member to summarize verbally the content of his letter. Mr. Eiermann reported samples have not yet been received by FDA and noted that FDA plans to provide Dr. Langer with samples collected by FDA in 1975. Dr. Estrin requested code numbers be identified to ensure the samples collected represent current production. Mr. Eiermann read the code numbers for products from Avon, Chesebrough-Pond/ Colgate-Palmolive, Helena Rubinstein and Sterling Drug. He afterwards provided the code numbrs for The Mennen Company. Dr. Schaffner advised inclusion of a chrysotile method in the CTFA Standards. Dr. Stewart responded he has not found chrysotile with instrumentation having a sensitivity of 2%. It was noted with instumentation having a sentivitity of a half a percent chrysotile also had not been found. Mr. Eiermann reported on FDA's analysis of 76 samples of talc products; no detectable findings of chrysotile by optical microscopy or tremolite by DTA were reported. Mr. Sandland noted the expected publication in the near future, of a revised standard for talc. The possibility was suggested that suppliers would afix a tag noting that their talc was CTFA grade. Mr. Eiermann discussed the problems involved in developing a statistically significant sampling plan for talc. Mr. Roesch noted the history of the mine source is very important and he was confident in the sources used to provide talc to the cosmetic industry. Mr. Eiermann agreed the data provided today gives the f. i Goodhue WCD 000252 3 PDA assurance of the purity of tale, but he needed information as to what universe these results represent. He asked how one could be assured that the results would represent tomorrow's talcs or those produced a year from how. He asked rhetorically, how do you control talcs. By regulation. How many samples would be .^ required. What would be the frequency of sampling. Would composites be desirable. Dr. Berdick stated categorically it was not feasible to develop a statistically valid sampling plan for talc. Dr. Estrin expressed bewilderment, that after reviewing the,nearly 4,000 analyses provided at this meeting, FDA would need anything further. Dr. Schaffner echoed Mr. Eiermann's recommendations that an adequate sampling plan be developed for quality assurance for talc. Mr. Sandland suggested if FDA considered all the talcs tested as being in one lot, the fact becomes apparent that no sample has . given positive results and this is a fact of very great statistical significance. A Dr. Schaffner and Mr. Eiermann"noted the oversight hearings taking place today and the fact that talc would be discussed at those meetings and the pressures that they are under to develop such an approach. In addition, Dr. Schaffner gave as analogies the specifications for botulism in food and pesticides in food. Dr. Berdick responded those very examples show that FDA relies on reports from industry on their practices rather.than requiring statistical sampling of food products. Dr. Schaffner suggested the possibility of having industry report periodically on the results of its analyses to the FDA. Dr. Estrin responded the subcommittee would give serious consideration to this suggestion. Dr. Schaffner noted the FDA is considering using the information submitted by industry together with its own data to prepare, a press release. There being no further business, the meeting adjourned. Norman Estrin, Ph.D. Vice President - Science NFE:MP March 18, 1976 Goodhue WCD 000253