Document MRXnRrjONK7L5zprBeyvmjQ7

MEMORANDUM OF TELEPHONE CONVERSATION Friday, February 27, 1976 BETOEEN: Marion Burros Reporter The Washington Post and Heinz J. Eiermann, Director Division of Cosmetics Technology Food and Drug Administration Subject: Asbestos in Talc Ms. Burros called at approximately 10:30 a.m. to inquire about the current status of our efforts with regard to the regulation of asbest in cosmetic talc products. She indicated that she had already talked to Dr. Shapiro (HFF-108) on this subject on February 10 and that she head had a conversation before that with Dr. I. Selikoff of Mt. Sinai School of Medicine. The following account covers the essential point of our conversation: (1) Analytical Evaluation of Commercial Talc Samples. In 1973, t agency had Dr. S. Z. Lewin, New York University, evaluate 195 samples of commercial talc products by x-ray diffraction. Dr. Lewin reported Chrysotile in 17 samples and Tremolite in 23. Other investigators, including the FDA, using other analytical methods, could not confirm the Lewin results, particularly in regard to Chrysotile. None of the Chrysotile results could be duplicated. In addition, DCST evaluated samples and consumer complaint samples for Tremolite and Chrysotile by DTA and optical microscopy and none was detected at the detectable level of approximately 0.5%. (2) Analytical Methodology. Currently available instrumental met dology which is suitable for routine quality control of talc is diffe thermal analysis (DTA) for the determination of Chrysotile at a level sensitivity of about 0.5 - 1.0% and stepscanning x-ray diffraction fo. the determination of Tremolite at a concentration of 0.3 - 0.5% (and Chrysotile when the talc is free of Chlorite, a common talc component These methods do not differentiate between fibrous and non-fibrous asbestos, and samples would have to be further analyzed by optical m i copy to confirm fibrous asbestos. In the case of Chrysotile where fi are usually too small to be visible under the microscope, this detenu tion is not always successful. Electron microscopy is not a suitable method for routine evaluation of talc because of the time-consuming methodology and the nature of talc mining and processing which demand multiple, continuous sampling to arrive at statistically meaningful results. Accordingly, our efforts during the past year, aside from analyzing commercial samples, concentrated on improvement in the F l o a t ^ i m Yt however, the e ^ ^ 2 1f o r f a ^7.jT^eri e S t O S 0,6 aforeIrentioned mathods. ere investigated, in separata on of t o l r T d noi,e"coura9 ^ fr reasons of p r o b l e m densities. engaged in '- A simi laxsl ndi I T T ^ - due to C l a r i t y in f the CTFA has been conclusions. StUdleS ^ at essentially the same whether we d e t e m m e the threshold concentration of a s t e S s S ? ? lung canoer. The answer was that such s t e S f S s ^ l Produced and were not index way She expressed 3k n h d 1x2611 nducte3 was toxic when inhaled vn0ern that talc itself deononstrating a ^ e f f L S ^ her of a recent!v o ., ' un ot talc, and I informed for Johnson s John."! ! The r e s u l t at 831 effects iron inhalation of exaggerated S e the conversation ohm 2ci,a j , ft SSs ieveis* ^Said loward the end o ,i effects of N i S e l l S S f t presence of toxicity of Nihkel cw^1 t t ^ ronoamed about the toxic ttat " e had " P l e d g e of the l a? " l n f o m a t Ln on the inhalatior of NichYi i n ^ d ^ r r 3^ s eb f t o 5 r d ^ ^ p-- why * d 5 9S f f S I l i 2 ' ? S in9 ^ f 05' a ^ r o s wanted to know and talc u s S as" j S 2 l ? ? ? POS;d 5 ^ ^ " . " asbestos in food 1973 (38 PR 37076! m , ditrve which was published on September 28, that " m of d e ^ S S o n t o o t i ^ ^ * " "* t ^ s L n d i n g ' for the aforementioned investicrati nn wu ^reanson,s and that other methods Was m s a t isfacto were under that I could not p r o v i d e ^ p T c i f i c ^ n f ^ ? 0^ h ^ 5 Were' 1 r e p H e d our efforts in the analytical field however/ wa would contu in the evaluation T nethodlo9y ^ d unable in recent investiaations cosmetic talc samples. a' ^ adready explained, we were 111 ashestos contaminated commercj (b) (5) Heinz J. Eiermann