Document rxVn8b7joBKaM97gZG6RQa78q

MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADM IN ISTRATIO N T O Robert M. Schaffner, Ph.D. DATE: March 18, 1976 Associate Director for Technology (HFF-400) F R O M Director, Division of Cosmetics Technology (HFF-440) SU BJECT: Asbestos in Talc I reviewed the correspondence submitted by CTFA's Dr. Estrin at the meeting of th CTFA Talc Subcommittee with the FDA on March 15 and would like to submit the following comments: AVON had McCrone Associates, a consulting laboratory, evaluate in 1973, 170 talc samples by x-ray diffraction (X-RI)). Since 1974, 250 samples have been evaluated in-house by differential thermal analysis (DTA) and by infrared spectroscopy (IR) for tremolite. This amount of analytical work appears to confirm Avon's statement that essentially every shipment of talc is tested. I do not know whether IR is adequate to determine tremolite. CHESEBROUGH-PONDS conducted 84 analyses in the last three years for chrysotile and amphiboles by X-RD. Where X-RD showed positive results the samples were subjected to analysis by optical micro scopy (OM) to verify the fibrous structure. Chesebrough-Ponds appears to be conducting only random analyses considering their talc business, number of tests conducted and the fact that talcs from three different sources are concurrently being used. COLGATE-PALMOLIVE claims to have conducted 42 talc analyses since 1971, however, these analyses reflect only 20 raw materials and 17 finished products, and the same material may have been tested twice, first as a raw material and then as a finished product. Tests have been conducted by McCrone Associates and in-house using X-RD and OM or TEM where necessary to determine the fibrous structure. Three samples, two in 1971 and one in 1972, were found to contain chrysotile up to 100 ppm which Colgate-Palmolive claims to be possible background contamination. Considering the size of Colgate-Palmolive's talc business/the analytical effort is very small. COTY claims to have analyzed selected lots of talc by X-RL and TEM at Pfizer's Laboratory. No numbers of analyses are provided. The talc supplier is Whittaker, Clark & Daniels. CYPRESS INDUSTRIAL MINERALS, CO., a supplier of Montana Talc to the cosmetic industry claims to have conducted 2,839 evaluations by CTFA's Associate Director for Technology 3 WHITTAKER, CLARK & DANIELS (WC&D); perhaps the most important supplier of talcs of various origins and quality grades to the cosmetic industry, claims to have analyzed, under contract, 74 samples during the past four years. Considering the nature of WC&DTs business volume, the variety of sources of supply, the various quality grades of talc involved, and the fact that this firm also supplies other industries with industrial talcs, which do contain asbestos, I am greatly concerned about their limited effort to control the quality of their cosmetic talc. Their sales catalogue lists at least 20 grades of types of cosmetic talc. Accordingly, any type of talc underwent one analysis for asbestos per year. On the basis of this effort WC&D have provided their consumers with written assurance that they routinely monitor shipments of talc for asbestiform minerals and have found no detectable amounts, This assurance might be mis leading and give the cosmetic industry the false impression that WC&D talcs are adequately tested for asbestos. I am also very much concerned about the fact that a firm of this standing in the cosmetic industry does not have facilities to do its own analytical work. In summary, though the submission by the CTFA Talc Subcommittee looks impressive at first hand, it does not offer much assurance that cosmetic talcs are adequately tested for asbestos. If this is all that can be expected from the cosmetic industry in the form of analytical effort in the light of the asbestos in talc publicity since 1971, we have not much choice but to move ahead as speedily as possible with a proposal of a regulation on asbestos in talc using X-RD and DTA procedures and basing the levels of adulteration of talc with asbestos fibers on the levels of sensitivity provided by these methods. Heinz J. Eiermann