Joseph Campau at the &Detroit, M ichigan 48232 Telephone (313) 567-5300 Quality Comrol and ^ Governmen' Regulations Division PARKE-DAVIS December 19, 1973 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fishers LanRockville, Maryland Gentlemen: As a manufacturer of biological and pharmaceutical (both oral and parenteral) products, Parke, Davis & Company is an interested person concerning. the Commissioner's proposals and related petition on asbestos in fQfpd and drugs as published in the Federal Register of September 28, 3.973, page 27076.

The Cosmetic, Toiletry and Fragrance Association, Inc. 1625 EYE STREET, N W , WASHINGTON, D C 20006 202/393-2070 December 26, 1973 James H Merritt P re s id e n t Norman F.

I'A'v i h o w i i a j Aij iiisK M in i (i, 13 2 - 1 1 3 (,1973) # A Study of Workers Exposed to Asbestiform Minerals in Commercial Talc Manufacture M.

ifetrch 5, 1973 M$* liarjorie &*K* Inservice Education Coordinator Edgamoor Geriatric hospital Horth Mgemoor Drive Santee, California 92071 Dear He* Briggsi Vour letter o February 6, 1973 to the attention of the Food and Drug Administration hm been referred Iso me for reply* We are at present cxapilta$ information on various talc products, but this is not yet ready for release* Inhalation of large rraomat of eshastee, a# in occupational exposure, is kno&tt to increase the incidence of lung cancer and pwseothelfossa, e&peeially in heavy sobers of cigarettes* Aabeafcos is often found- as a. natural contaminont of talc; both are magnesium silicates, end aro geochemicalXy Infcercoarvcriifele* Taleoei* if seaa only tmder conditions of heavy exposure and talc has not been demonstrated of itself to bo careino^onic* the levels of the various types of asbestos found in talc vary depending upon the source frm. which the talc comas, and: the use for Which it is intended, i.s* ties in heavy Industry, food UqpmUmdt, cosmetic* Generally* the bat-tar grades of commtc and food talcs are reportedly free of ae~ bastes* Iveadlcss to- ay, the suppliers and cotaaercial users of talc are aware of the potential problems presented cad in the last year or so the industry lias made an effort to reduce or eliminate asbestos in talc as required* Two statements from 1971 report on Asbestos by the national Acatoay of Sciences are of interest there are levels of asbestos exposure that will not he associated vlth any detectable risk.

DETERMINATION OF ASBESTOS T"i TALC BY OPTICAL MICROSCOPY The six kinds of asbestos can he distinguish.ee] from talc and from each other by their refractive indices, other optical crystallographic properties, and morphology as determined with a polarizing- microscope (AOAC 1970 36.54136.543).

BETWEEN: SUBJECT: MEMORANDUM OF MEETING January 7, 1975 FDA Representatives Robert M.

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUDLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATION W A S H IN G T O N , D .C . 20204 O ctober 6, 1971 To: P a r tic ip a n ts in "A sbestos and T a lc " D iscusicm S e s s io n a t FDA on August 3_p 197 X A ttach ed i s a s u g a r y o f om re ce n t D iscu ssio n Sees lux* cm "A&bestos and T a l c ," As warty o f yen I have requested submissions o f de t a i l e d a n a ly t ic a l procedures frees a l l o f the la b o r a to r ie s rep resen ted which perform each work.

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION WASHINGTON.

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CABLE -SLE1NAD* (2 0 !)

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r-s,t-7f Cyprus Mines Corporation 555 Soulh Flower Streel Los Angeles, California 90071 Telephone 213),189-3700 Cable Selmud Losangeles Telex 67-4601 CONFIDENTIAL Mr.

V ; `V ." i ^ f w o c o ) .

BABY PRODUCTS COMPANY RETURN RECEIPT REQUESTE R A R IT A N .

*1 X, th .i 28 June 1971 TO: Mr.