Document QJ51mQqyndvNvBa24OwZO0N4E

A/s N O R W E G I A N T A L C MINfPili Food and Drug Administration Hearing Clerk Ron 6 - 8 6 5600 Fishers Lane Rockville, M D 20852 U.S.A. P .O .B O X 744. N -$001 B ER G EN . NORW AY TELEGRAM S: TALKUM - BERGEN T E L E P R I N T E R NO. 4 2034 - OW NER N T E L E P H O N E N A T I O N A L (05) 27 15 80 I N T . N A T - f 47 5 27 15 80 O U F R E F hjk/lm YOU R REF b e r g e n June 19, 1974 Re : Asbestos particles - FDA proposal on adulteration of food and drugs. Federal Register Sept. 28, 1973, page 27076 ( FR Doc. 73-20711, filed 9.27.73 ) Gentlemen : Subject proposal was brought to our attention by a European customer who was evaluating one of our talc grades. However, by the time we had obtained a copy of the proposed method for determination of asbestos in talc and tested it, the closing date for filing of comments was by far exceeded. Nevertheless, we would still like to give our comments on the proposed test method. Our analytical laboratory has reviewed the proposed method as referred to in F.R., Vol 38, No. 188, Sept. 28, 1973, page 27079, 121.2006. They conclude that this method can not be used to determine possible asbestos particles in finely ground talcs. This concerns in particular one of our products, Micro-Talc I.T. Extra, which has the following particle size distribution as determined by sedimentation analysis : Particles < 20 pm ( micron ) < 10 pm < 5 pm < 2 pm 100% 99 % 85 % 40% Thus, it is our opinion that this method does not permit an accurate and satisfactory way of determining possible content of asbestos in talcs. For your information, our Micro-Talc I.T. Extra, of which a technical data sheet is enclosed, is produced from Indian talc raw material. It is not of the needle shaped types like for instance the talcs produced from talc deposits in the State of New York. Page 2 - (2/65 A/s N O R W E G IA N T A LC Food and Drug Admmistral-ion dat 19.6.74 SHEET NO. To investigate M icro-Talc I.T. Extra for possible content of asbestos, we have on our part had it analysed by x-ray diffraction method and with the polarisation microscope. None of the two methods did identify the presence of asbestos particles. In this context we would also like to be informed about when the FD A expects to have reviewed the received comments in this matter, and when new action will be taken. We would also like to know if comments received from interested parties are public documents and, if so, if copies thereof can be obtained from your office. We hope our viewpoints are of interest to you, and that you will answer the above two questions. If you should have any questions regarding our comments, please let us know. Yours very truly, pr. A/S N O R W E G IA N TALC H . J. Knudsen Enel.: Technical data sheet for M icro-Talc I.T. Extra