Document yk6e56d7RbyOJNYEjJ0k4vKnX

M eeting D ate: December 4, 1974 R elease D ate: December 19, 1974 MEETING NOTES 01 CTFA TALC SUBCOMMITTEE PRESENT; Mr. George Sandland, Chairman D r. George Cohen Mr, Alan M. Harvey Mr. Ray Krammes Mr. George Lee Dr. F. Robert R olle Mr. Jo sep h Simko Mr. Harold S ta n le y , J r Dr. John T ravers COPY: Dr. Murray B erdick Dr. C hristopher C o stello Mr. S a lv a to re D iBianca Dr. John M enkart D r. Norman E s t r l n Mr. Eugene 1. Lambert Mr. Fred Roesch D r. C. S. Thompson Mr. Ronald Yakupcin B ristol-M yers Products rietol-M yers Products R. T. V a n d e rb ilt W hittaker, Clark & D aniels Johnson & Johnson Johnson & Johnson C olgate-Palm olive P fizer Avon P ro d u cts Chesebrough-Ponds - C olgate-Palm olive Hennen Co. C lairol CTFA Covington & B urling W hittaker, Clark & D aniels R. T. V an d erb ilt Kolmar L a b o ra to rie s The m eeting was h eld In th e B ristol-M yers T echnical S ervices C o n feren ce Room a t H i l l s i d e , N. J , G .'S a n d la n d p r e s id e d . ^u w T IF F ? EXHIBIT WCD-404 Goodhue WCD 000242 The com m ittee d isc u sse d th e r e s u lt s o f th e round ro b in te s tin g of ta lc samples to e v a lu a te th e D TA /optical microscope procedure fo r c h ry so tlle and th e x -ray d iffr a c tio n /o p tic a l m icroscope p ro c e d u re f o r am p h ib o le, d ev elo p ed by th e Ad Hoc M ethodology C om m ittee, I t was concluded t h a t we can recommend x - r a y d i f f r a c t i o n w ith the o p tic a l m icroscope as back-up fo r the d e te c tio n of amphibole a t a 1% l e v e l . , Only 2 members s u p p lie d d a t a u s in g th e DTA p ro c e d u re f o r s e rp e n tin e . The use of th e o p tic a l m icroscope as back-up to d if f e r e n tia te n o n -fib ro u s serp en tin e (a ritig o rite ) from fib ro u s s e rp e n tin e (c h ry s o tlle ) was shown to be u n re lia b le based on r e s u l t s from 3 in v e s tig a to rs . In v e s tig a to r and R esu lts Coded Sample Lucy St W a lte r McCrone H. S ta n le y McCrone A s s o c ia te s P f i z e r D. Hamer Johnson & Johnson A - Talc Sample from P fizer containing c h ry so tlle and A ntigorlte none d etected pass c h ry s o tlle C h ry so tlle found found - f a i l fa il B-1% C h r y s o tlle i n Talc prepared by a sim ulated in d u s tria l m illing process c h ry so tlle found none found fa il pass C hrysotlle found fa il C-l.2% fib ro u s t a l c in platy talc none found pass none found pass none found pass The o n ly o th e r b ac k -u p p ro c e d u re w ould b e TEM w hich t h e o r e t i c a l l y i s s a tis f a c to r y , b u t which has the follow ing d isad v an tag es: 1. Lack o f a v a ila b ility to most ta lc u se rs. 2. I t s u ltr a s e n s itiv ity could be a problem. 3. A s t a t i s t i c a l l y s ig n if ic a n t sam ple s iz e cannot be examined w ith in a reasonable tim e frame. 4. Hot amenable or com patible in a Q u ality A ssurance environm ent. Goodhue WCD 000243 - 2- S in c e we do n o t h av e a r e a d i l y a v a i l a b l e b ack -u p f o r DTA, i t was agreed t h a t we would have to depend s o le ly on i t , knowing th a t i t w ill d e te c t b o th fib ro u s and n o n -fib ro u s s e r p e n tin e . However, sin c e no one to our knowledge has ever d e te c te d c h ry s o tile or a n tig o r ite by DTA i n any c o sm e tic t a l c , i t i s o u r o p in io n t h a t th e r i s k in v o lv e d , w ithout a back-up method, is extrem ely sm all. The com m ittee co n c u rre d , th o u g h , t h a t we sh o u ld o b ta in a d d i t i o n a l d a ta to co n firm th e r e l i a b i l i t y o f DTA. Avon and Johnson & Johnson a lre a d y have c o n trib u te d d a ta . The follo w in g a d d itio n a l so u rc es o f d a ta w i l l p ro b ab ly b e a v a ila b le w ith in th e n e x t few weeks: < H. S ta n le y ( P f i z e r ) - e x p e c ts d e l i v e r y o f new DTA (M e ttle r ) t h i s week and w ill do sam ples. S. DiBianca(Mennen) - expects re c e ip t of 1200 c e ll very soon and w i l l do a s soon as p o s s i b l e . Has d uP ont DTA. R. Krammes (W h itta k e r, C la rk & D a n ie ls ) - w i l l h av e sam ples a n a ly z e d by De B el and R ic h a rd so n T e s tin g I n s t i t u t e , E n f ie ld , Conn. J . Simko (C o lg a te -P a lm o liv e ) - e x p e c ts to p u rc h a s e DTA, b u t w i l l attem pt to have samples run by th e In stru m en t s u p p l i e r p r i o r to p u rc h a s e . Mr. Simko f e e l s th a t te s ts could be com pleted w ith in nex t 2 m onths. Dr. R olle w ill fu rn ish coded sam ples to each of th e above p artic ip a n ts as required. One o f th e o r i g i n a l aims o f o u r Ad Hoc M ethodology Committee was to w ork c o l l a b o r a t i v e l y w ith th e t e c h n i c a l s t a f f a t PDA, and a t f i r s t , i t appeared th a t John S tu a rt would be th e c o n ta c t. However, he has been deluged w ith assignm ents to the ex te n t th a t he has been unable to be an a c tiv e p a r tic ip a n t on th e Methodology Committee. T his i s u n fo rtu n a te , s in c e su ch a d i v i s iv e arrangem ent h as made i t v i r t u a l l y im p o ssib le to ap p ro ach o u r g o a l on a common ground w ith FDA. I t was su g g e ste d t h a t we a tte m p t to s e t up a l i a i s o n m eetin g w ith Dr. S h a ffn e r o r Mr. Eierm ann i n o rd e r to e s t a b l i s h a c o lla b o r a tiv e approach to the problem s involved in th is p ro je c t. Goodhue WCD 000244 3 Mr. S andland p o in te d o u t t h a t CTFA m eets w ith FDA ro u tin e ly by means of th e Government L ia iso n Committee, and agreed to d is c u s s th e m a tte r w ith Dr. E s tr in in o rd e r to d eterm in e th e b e s t way to re so lv e the problem . Mr. Harvey c a lle d th e a t t e n t i o n o f th e com m ittee to an e n try in th e F ed eral R e g iste r o f Monday, J u ly 1 , 1974, p e r ta in in g to D epartm ent o f th e I n t e r i o r , Bureau o f Mines and d e fin in g H ealth and S afety S ta n d ard s in M etal and N o n m etallic Open P i t M ines. T hreshold l i m i t v alu es a re s ta te d fo r "asb e sto s" which i s d efin ed to in clu d e only e h ry so tlle , am oslte, c ro c id o lite , anthophylite asb esto s, trem o lite a sb e sto s and a c t i n o l i t e a s b e s to s . The word " a s b e s to s " i s in c lu d e d in naming th e l a s t 3 m a te r ia ls in o rd e r to d i f f e r e n t i a t e them from th e non-asbestiform types o f these m a te ria ls, such as trem o lite of a nonasb e etifo rm , which occurs in ta lc d e p o s its , and i s n o t m entioned in the d e fin itio n , and, th e re fo re , is not covered in the reg u latio n . The S-hour tim e w eighted average a irb o rn e c o n c e n tra tio n o f a sb e sto s dust to which employees are exposed s h a ll n o t exceed 5 fib e rs p e r m i l l i l i t e r , g r e a t e r th a n 5 m icro n s i n l e n g t h . Mo em ployee s h a l l b e exposed a t any tim e to airb o rn e co n cen tratio n s o f asb esto s fib e rs in ex cess o f 10 f ib e r s lo n g e r than 5 m icro n s, p e r m i l l i l i t e r o f a i r , as d e te rm in e d by th e membrane f i l t e r m ethod o v e r a minimum sam p lin g tim e o f 15 m in u te s. Mr. H arvey a l s o s t a t e d t h a t NXOSH i s c o n s id e r in g th e estab lish m en t of a stan d ard fo r ta lc which w ill be se p a ra te from the asb esto s stan d ard . This w ill re q u ire a jo in t overview study to determ ine the n a tu re of a l l ta lc s and w ill probably take 2 to 3 years to com plete from th e tim e I t is s ta r te d . Mr. Krannr.es c i r c u l a t e d to th e com m ittee a F ie l d In fo rm a tio n Memorandum # 7 4-92, to a l l OSHA A s s i s t a n t R eg io n a l D ir e c to r s and A rea D ir e c to r s on th e s u b j e c t o f T re m o lite and T a lc , A copy o f t h e memorandum is attached. A s ig n if ic a n t fe a tu re which i s ap p aren t in both o f the above government p u b lic a tio n s i s a change in the d e f in itio n o f a f ib e r and an ap p aren t d ev iatio n from th e previous 3 to 1 asp e ct r a tio d e fin itio n . Goodhue WCD 000245 The n e x t m eeting w ill be h e ld on February 4, 1975 a t 10:00 A.M. a t th e B ris to l-M y e rs T e c h n ic a l S e r v ic e s C onference Room, 225 Long Avenue, H i l l s id e , N. J . The agenda w i l l in c lu d e : 1 , C o n s id e ra tio n o f a l l a v a il a b le d a t a on th e DTA a n a ly s is fo r C hrysotile. 2. F i n a l i z a t i o n o f o u r p ro p o s a l f o r p r e s e n t a t i o n to FDA. Y. W. S andland C hairm an, CTFA T a lc Subcom m ittee Goodhue WCD 000246