Document E302YZred4kYJLbDXejqr5jR

M ic h a e l F,MAmtHL V fjcn cE K. H i l l Wa l t b r E. B y URX-KT LA-WOPflCES Ma e k e l , Hi l l & B y e h l e y GOMMOITWKAI.T'ff B u i i d i s c D. C.1 6 2 E K S t h e ITT, N . W. W a s h in g t o n , 20006 (SOS) 6 3 3 - 0 5 3 0 September 28, 1973 Mr. George J. Dippold, Whittaker, Clark & Daniels 1.000 Coolidge Street South Plainfield, New Jersey Dear Mr. Dippold; 07080 FDA has finally published a long-awaited document concerning asbestos in food and drugs, and, particularly, in talc. We enclose herewith a Xerox copy of this complex document as published in today's Federal Register. The following observations with respect to the published proposals may assist in your evaluation of them. (1) These are proposals, not final regulations. Written comments on all of these are requested on or before December 27. (2) The proposals, by Center for Science in the Public Interest and by FDA, relate to food and to drugs, but do not relate to cosmetics. (3) The lengthy and interesting preamble to the FDA proposal establishes FDA awareness of the magnitude of the problem as well as the fact that it is not possible to eliminate all sources of asbestos contact with food and drugs. It also contains helpful scientific references. (4) FDA concludes that it is not presently possible to issue a final food additive regulation for talc "until a reproducible and accurate method can be specified for compliance purposes." (5) FDA obviously considered the comments which we filed in your behalf on October 12, 1972, in amending both its GRAS list proposed wording and its proposed food additive regu lation for talc. Note that these no longer speak in terms of c "free of asbestos-form particles." Also, FDA, in the preamble, describes with greater accuracy the meaning of "asbestos", though.the term, is still not fully defined. PLAINTIFFS WCFitDHl-B3i2r6 WCD000039 Mr. George J. Dippold September 28, 1973 (6) Note that comment is requested not only on the new proposed regulations but on all aspects of the public health significance, the need for use of asbestos-containing filters, the time heeded to switch over to other types, and on methods of quantitative assessment, j Please consider the enclosed aJhncd let me know if it is yo'ur desire to file further formal 'comments on these new proposals. If so, I believe it would be necessary for us . to meet with your technical personnel in order to appropriately plan proper comments which, you will note, will become part of the record available for public inspection. Best wishes, WKH:vr Enclosure ccj Mr. Frederick F. Beesoh Sincerely yours, , -XLtM Wayntf K. Hill it- 2- .17 ..i; r,f i*v WCD000040