Document Na08Q7JQe1YEgzQGjBMQGxvp

M eeting Date: February 4 , 1975 R elease Date: February 26, 1975 MEETING NOTES OF CTFA TALC'SUBCOMMITTEE PRESENT: Mr. George Sandland, Chairman Mr: S a lv a to r e DiBianca Dr. George Cohen Dr, A llan Harvey Mr. George Lee Dr, F. Robert R olle Dr. John Sch ela Mr. Joseph Sirako Dr. John Travers '1 Bristol-M yers Products Mnnen Co. Bristol-M yers Products R. T. V anderbilt Johnson & Johnson Johnson & Johnson Johnson 4 Johnson Colgate-Palm olive Avon Products COPY: Dr. Murray B erdick Dr. Christopher C ostello Mr, Ray Kraumes Mr. Fred Roesch Mr. Harold S ta n le y , Jr. Dr. C. S . Thompson Mr, Ronald Yakupcin Chesebrough-Ponds Colgate-Palm olive W hittaker, Clark & D aniels W hittaker, Clark & D aniels P fizer R. T, V an d erb ilt Kolmar L ab oratories CC: Members o f Standard Committee Ms. A n ita Curry Dr. Norman E str in Dr. John Menkart Mr. Eugene Lambert The m eetin g was h e ld i n th e T ech n ica l S e r v ic e s Conference Room a t B risto l-M y ers P ro d u cts, 225 Long Avenue, H i l l s i d e , N. J . ^ u mtf f ? EXHIBIT WCD-377 Goodhue WCD 000067 Jack Travers rep orted th a t NioSH has proposed a r e v is e d (lo w er) TLV o f 50 m eg/cubic m eter fo r c r y s t a l li n e s i l i c a . i I ;* Bob R o lle d escrib ed th e l a t e s t r e s u l t s o f Round Robin #3 u sin g th e CTFA Proposed O p tica l M icroscope Procedure Tor D e te c tio n o f C h r y so tile i n T a lc. T his i s th e method in ten d ed to be u sed as a back-up to the DTA method, s in c e DTA can g iv e a f a l s e p o s it iv e fo r c h r y s o t ile when non fib r o u s a n t ig o r it e i s p r e se n t. U n fo r tu n a te ly , th ere was disagreem ent among 3 v ery capable i n v e s t i g a t o r s , McCrone A s s o c ia te s , Harold S ta n le y o f P fiz e r and Dave Hamer o f Johnson & Johnson. I t was agreed, however, th at c h r y s o tile i s never found in co sm etic t a l c s , based on numerous a n a ly se s by s e v e r a l i n v e s t ig a t o r s . The o n ly d isc o v e r e r o f c h r y s o t ile in cosm etic t a lc s has been P rofessor Lewin, and h is r e s u lts have been refuted in a r e p e a t t e s t i n g o f th e same samples by John S tu a rt a t FDA. The com mittee concurred, th e r e fo r e , th a t our o n ly cou rses o f a c t io n are e it h e r to r e ly only on DTA by i t s e l f (w ithou t a back-up p rocedure), or e ls e , based on the w ealth o f data a v a ila b le , elim in ate the need fox a ch ry so tile sp e c ific a tio n in cosm etic ta lc . E ith er way, we are co n fid en t at th is p o in t, th a t c h r y s o tile w on 't be found and sim ply I s not p resen t in cosm etic t a lc . We are B t i l l a w aitin g a d d itio n a l DTA r e s u l t s on t a l c samples (some spiked) which were sen t to C olgate-P alm olive, Mennen, P f i z e r , and W hittaker Clark & D a n ie ls . In a d d itio n , Jack Travers has su b m itted a s e t o f samples to John R effn er (V. o f Comm) fo r DTA a n a ly s is . Jack S ch elz d escrib ed an in e x p e n siv e DTA u n it s o ld by Columbia S c i e n t i f i c In d u s tr ie s c o s tin g $3350 w ith o u t a reco rd er and about $4600 w ith a recorder. This instrum ent was evaluated by Dr. S ch elz and was found to he capable o f d e te c tin g se r p e n tin e m in erals above th e 0.5% w/w l e v e l in t a l c , when u sed accord in g to th e proposed CTFA t e s t method. .. I t was agreed th a t we in c lu d e i n th e procedure fo r c h r y s o t il e , th e l a t e s t d e f in it io n o f a f i b e r as p u b lish ed by 0SHA in F ie ld Inform ation Memorandum `7 4 -9 2 , w hich was s e n t to OSHA A s s is t a n t R egion al D ir e c to r s and Area D ir e c t o r s . This memorandum sta tes that: "In order to he considered asbestiform or fib rou s the fo llo w in g c r it e r ia w i l l be used by th e S a lt Lake City Laboratory o f OSHA, Goodhue WCD 000068 - 2- A. P a r t ic le s m ust appear to b e fib r o u s , ra th e r than as crystals or sliv e r s. 5 . The maximum diam eter o f a f ib e r to be counted i s 3 m icrons. C. The maximum le n g th o f a f ib e r to be counted i s 30 m icron s. D. The le n g th to w id th r a t io must be 5 or more to 1 , th a t i s , 5 tim es or more lo n g e r than w id e. E. The se p a r a te or in d iv id u a l f ib e r s must co n ta in f i b r i l s or the "bundle o f stic k s" e f f e c t , u n less they are a t a n o n - d iv is ih le s ta g e . A f i b r i l cannot be su b d ivid ed and would be counted, i f i t meets the oth er c r it e r ia . The e le c tr o n m icroscope may be used to prove th e fib ro u s n atu re o f th e p a r t i c l e s . The len g th to w idth r a t io s o f 5 or more to 1 Is n ot meant to im ply th a t o th er p a r t i c l e s are not hazardous." The d ir e c t i v e s t a t e s a t th e end th a t th e above guidance i s temporary and may change as a r e s u l t o f fin d in g s from an o n -goin g NIOSH study on t h i s s u b j e c t. A CTFA T alc Task Porce com prised o f Dr. B erd ick , Dr. E str in (CTFA), Mr. L ee, Dr. R o lle and Mr. Sandland w i l l meet w ith Dr. Robert S c h a ffn e r , M r.. Eiermann and t h e ir d esig n a ted p erso n n el a t FDA on F rid ay, February 7, 1975. I t i s planned to p ropose the 0 .5 to 1.0% lim it for each fib ro u s trem o lite and c h r y s o tile In cosm etic t a lc . Our CTFA Task F orce developed methodology w i l l be subm itted in l a t e s t form as p a rt o f th e p r o p o sa l. A p relim in a ry m eeting a t CTFA Headquarters w i l l be h e ld in th e morning and th e m eeting w ith FDA i s sch ed u led a t 1:00 P.M. A r e p o r t o f t h i s m eeting w i l l be subm itted to the members o f th e CTFA T ale Subcom mittee, A llan Harvey rep o rted th a t he w i l l a tten d a m eeting on Tuesday, February 1 1 , 1975 which has been c a lle d by Dr. Raymond E. Shapiro o f FDA who i s h ead in g up a Subcommittee on A sb estos P r o to c o ls . This subcommittee was assign ed the job o f review ing a l l e x is tin g data w ith resp ect to the b io lo g ic a l e ffe c ts of o ra lly adm inistered asb estos, w ith p a r tic u la r re fer en ce to ca r c in o g e n e sis, and i f n ecessary o f Goodhue WCD 000069 - 3- dd evelop in g a p p rop riate p r o to c o ls f o r studies:' to e la b o r a te on sn i data d eficien cies in th is area. I At the m eeting of February 11th, the subcommittee members w i l l d is c u s s a working d r a ft which has been fu rn ish ed to them to p rovid e a b a s is fo r comment and d is c u s s io n . A paper e n title d "Is Short-Fibered A sbestos Dust a B io lo g ic a l Hazard?" by Paul G ross, M. D. , C h a rlesto n , S. C. was d iscu ssed . Here Gross s ta te s there i s evidence th a t asb estos p a r t i c l e s which are subm icroscopic in s i z e (<5 m ic r o n s ) e lic it only a macrophage re a ctio n in the lungs o f monkeys. Sim ilar r e su lts r e s u lte d in s e v e r a l oth er anim als in c lu d in g r a ts and ham sters when subm icroscopic a sb e sto s was in j e c t e d in t r a t r a c h e a lly and ln t r a-ab dom inally. There b ein g no fu r th e r b u s in e s s , th e m eeting was adjourned. W. Sandland Chairman, CTFA T alc Subcommittee Goodhue WCD 000070 |r V ''{/ J A A A a^ -Z.^- talc fa -fz ^ fe sr CTF Specification TALC (Form erly TGA.Spac No. 10} idSiiei*?: 6-]-<12 ftarfejid; 3-23-G;: G'30-7J D E F IN IT IO N : Talc is a white, odorless or very slightly earthy, finely powdered, native, hydrous, magnesium silicate, sometimes containing a small portion o aluminum silicate. TEST 1 Color ......................................... SP ECIFJCATION 1 ! As specified by the buyer and showing no change after heating METHOD Heat 1 to 2 g at 200C for 5 mmutes Odorless . . As specified by the buyer Identification Positive: Close match to CTFA Spectrum--IR with no indication of foreign materials CTFA G 3-1 Slip Lustre , . . . , As specified by the buyer Do. Carbonates . . . No effervescence USP X V III, page 70S Observe reaction for aifsrveacence during digestion in Test for Acid-Soluble Substances Water-Soluble Iron Passes test USP XVI11, page 703 Screen Test . . , 100% through 100 mesh 98% minimum through 500 mesh Finer grades: as specified by the buyer CTFA C 6-1 Alkalis and A cids. Neutral to litmus paper USP X V III, page 708 See Test for Reaction and Sol uble Substances. .Water Soluble Substances . . 0.1% maximum Do. Acid-Soluble Substances . , . 2.0% maximum USP X V III, page 708 Loss on Ig n itio n ....................... 5.0% maximum Do. ` Arsenic (as A s )............................ 3 ppm maximum CTFA F 1-1, Parts I-A and II Lead (as Pb) . . . . . . . . 20 ppm maximum CTFA F 2-1, Parts l-A and II t T f / t -- ----- H rC COSMETIC,TOILETRY AND FRAGRANCE ASSOCIATION, INC. 1625 Eye Street. N.W., Washington Goodhue WCD 000071