Document a1EmqkXjpYqjnjOmGxX0Jr90b

FILE NAME: Talc (TALC) DATE: 1974 DOC#: TALC079 DOCUMENT DESCRIPTION: Letter to NIOSH RE Proposed Regulation Asbestos Particles in Food & Drugs 5* r r *r \ * \* - + \ r W * - A - V. CD hatlocal T )o'o-:uy; Fieri: . l-ood and Drue d i t i n i s t r a t i o i i t i t u t c f o r O c c u p a tio n a l S a f e t y ami H e a lth JAM 2 1 74 r e ctor, H a1 i-rhiho for OccupnH r-v,.\ finfoty ar.d Health J're-por.'C'd 'hfi'.lrt'.ion or' Asbestos Partidos In Food r>.r;d Drugs Tc- proponed regal ati <::! or; asbestos particles in food and drugs, described ir. d e rdHral j"-'! oter of Sopinrobor tS, l`J73 (2j fh. Farts 121 and 153)7 las' eon r e d eved and coronents are offered. Pago ?7077 2nd Col ur.n, ?::d full earngraph An additional reference could be included to deneriue the b'T.Ofih air repulir; colnviquc for asbesto:;: Leicel, 'A cl; al, bob: S/ DTX'Sli 'eel/isro Filter L'lcthol for hvrJ.ur.tiwg \irLcrne. Asbestos Fibers, 11-54, I'i'T M , PrS, NTOCH, Cincinnati, Ohio. (It is rov ,;in press" nrd should be publisn&d soon.) fie_cH.cn _77ix.77!7iiil_*_ - .The polarised light rcicroscr.pe techniques that are presented in this paragraph arc vc-.ry biff icult: and grconb-iy ovcrsi'rd if tea m the. proposed icgd ation. it is sute este cl teat t.ie r.-etbCK. oe referred 1:o in the regulation and in another putiication give stop--by--rstee procedures lo Le lollov'c, m i s is not accopplisi.cd in the 'reference to the AGAC bethods. . It is doubtful that the reconncndcd technique for dispersing taJe on, the oicrcseopci slide, r.entioned in lection l2i,,o!;6(c) (a) .. \iiil provide a unifori; particle distribution. It is expected that problems will he encountered when the slide cover is placed over the r.ui.-.nle, in tint the particles and liquid vil! tend to he ^ dispersed towards the outer edp.es of the slide. It is belueved vaore research is needed to ensure obtaining uniform particle - dispersion. , . .* The winiri-ura number of slide fields or nonlcr of filers per alteo that curt he counted r.uni: ho. stipulated so that conversion to fibers per rtiili.gram of saw-pie can he calculated. This tiimr.um 2 - sharing.1<'3crh ,ri)A . Duvhfr fitpend on t.ho tntiol icu of uniform distribution of particles doter^nci ttB in action CO above. The method for converting from number of fiber counted to the w e t of irtora Pe\ ^ ^ , rd-nuld 0 s-.c# bo stipulated, no i u uenr an trie uIG-li criteria docoru n o n noboot no (IhA reference 3) or in the previously mentioned IJlOG'i T i - b i . It -iru-d be iurKcntnh that fiber determinations chould be made on the" (Ire- a m p l e r , before and nicer filter application, since the fibers bo present prior to filter app.ii.cnL.ion. There is no indication of: how a "fiber-rcleesing filter" io found to be so. Io fiber counting to be conducted! a crer-ntsea reduction in fiber content should be stipulated, rather than a requirement "...to reduce the content of any asbetos~orm partides.. . The reference to the KIQS1T criteria document on asbestos for methods to defcc-vrine ucbectos reduction is not sufficient because the tech-duos described in that document arc for d r coup l end UuC& the Fibers arc on a r-illipore filter, subsequent proceuurna are adequate, bub sampling ire* a liquid u.ediuic vonia be cxrroraut than s^pXr.r/rom nlr, and these different aanpldc; procedures e h o u i a be described. If the statement that thorn shall be no fibers released into drugs is nernt lit ally, then the use of phase contrast mcroocopy, as d^ac'-ibef in. the , h O d criteria document, is not cuincaoit. av'cr.nrdnsiQn electron microscopy mould have to be uccu to ensure U . n; fibers are releasedt However, tho KIOSK analytical procedures ore acceptable if you desire to simple for fibers greater t frv raicroTit? in length* Marcus M. Key, HJ1. AuHiotant Surgeon General NIOSH:ORSD:TRAB:JMny:sme :1/17/7/t Official file located in room 31S