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FILE NAME Talc TALC DATE 1973 Mar 2 DOC TALC073 DOCUMENT DESCRIPTION Letter to the Environmental Defense Fund from the FDA DEPARTMENT OF HEALTH EDUCATION AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION WASHINGTON D.C. 20204 March 2 1973 Dr. Lucile Adamson Staff Scientist Mr. Scott Lang Washington Counsel Environmental Defense Fund 1712 N Street N.W. Washington D.C. 20036 Dear Dr. Adamson and Mr. Lang I regret the long delay in replying to your letter about asbestos in talc Part of the delay was due to a heavy load of other responsibil- ities and part was due to a hope that events might have proceeded to the point this hope of resolution of the various questions involved has not yet been realized the lapse of time has Even though been great enough to impel me to write as follows in response to your specific ques- tions Your remarks on the health hazards of asbestos are of course well- founded this has been of concern to us for some time In August 1971 I organized a discussion session at FDA on asbestos in talc which was attended by almost fifty representatives of industry universities and government A major topic at the meeting was the analytical methodology for detecting small amounts of asbestos in talc This was recognized as a difficult problem which is best attacked by a battery of four methods optical microscopy ray diffraction electron microscopy and electron diffraction and possibly a fifth method elemental analysis by electron microprobe However it was noted that the combined use of all the methods would be almost prohibitively expensive One of those in attendance at the meeting was Prof. Seymour Z. Lewin of New York University a recognized expert on mineralogical chemistry and analysis Some time after the meeting I asked Dr. Lewin to undertake the analysis of samples of commercial talcum powder products for asbestos particularly the chrysotile and tremolite varieties by means of the ray diffraction technique primarily with additional work by optical microscopy as needed He carried out most of this work during 1972 to date he has examined 195 samples of talcum powders plus some miscellaneous samples for others at FDA Dr. Lewin has given us reports on his results from time to time but we do not yet have a truly final report from him Until we receive it we cannot publicize the incomplete information in our possession Dr. Lewin has written that the final report will be ready within a few weeks but he is a very busy man and our past experience suggests that it may not arrive until a few months from now Page 2 - Dr. Lucile Adamson and Mr. Scott Lang I hold a work of high regard for Dr. Lewin and the scientific course it is always necessary to maintain a quality of his critical attitude towards the results obtained by sophisticated analytical techniques This has been particularly true in the present case where the small amounts of asbestos involved and the presence of transitional and altered mineralogical species led to ambiguities in the data In his eagerness to protect the public interest to the fullest extent Dr. Lewin in certain cases interpreted borderline results as showing the presence of asbestos in his earlier reports but he later used a more conservative interpreta- tion He has spent a lot of time and energy in creative scientific work aimed at resolving the ambiguities for which the public and FDA owe him a debt of gratitude and he has succeeded for the most part As you may know some discussion of Dr. Lewin's earlier interpretation of the data was included in an article on asbestos in the Wall Street Journal of February 26 1973 Inasmuch as Dr. above comments Lewin's we have results are judged acceptable subject to the not undertaken a repeat survey Because of the possibility that optical microscopy alone may constitute an acceptable technique for the detection of asbestos in talc and is more generally available than ray diffraction we are currently making a comparison between Dr. Lewin's results on selected samples and the results obtained by house FDA microscopists After this comparison work is completed a decision will be made as to the preferred procedure for detection of asbestos in talc Details of the analytical procedure are needed for the official statement which FDA plans to issue on asbestos contamina- tion of talc One more point should be noted that FDA activities have already led to a substantial upgrading of the quality of talc used in cosmetic products This is evident both from the results obtained by Dr. Lewin upon reanalyses of a given product where repeat purchases were made at retail over a period of time and also from discussions with a principal supplier of talc who indicates that he now sells only asbestos grades of talc to the cosmetics industry With reference to your last question FDA has undertaken extensive literature surveys on the carcinogenicity of asbestos and of talc but the results thus far do not establish that tale itself is carcinogenic We also have had discussions with members of the National Cancer Institute where work is currently underway on carcinogenesis by fibers and minerals as well as other chemicals As you probably realize the mission and facilities of the National Cancer Institute are more appropriate than those of FDA for resolving the question of the possible carcinogenicity of pure talc also a period of many years will be needed to obtain the answer A oR aerate ante 4- oe a a aT qaj sore te ee Page 3 - Dr. Lucile Adamson and Mr. Scott Lang I trust that press regret the for above information the delay satisfies your needs and again ex- Sincerely yours sdeabnsied Junki Alfred Weissler Ph.D. Acting Director Division of Colors and Cosmetics Office of Product Technology Technology Fn ret Matern seinen cnitamsle sa tinea ree e Soe